Archive for November, 2012
Ever-Glory (EVK) Reports Third Quarter 2012 Financial Results
NANJING, China, Nov. 12, 2012 /PRNewswire/ — Ever-Glory International Group, Inc. (the “Company” or “Ever-Glory”) (NYSE MKT: EVK), a leading apparel supply chain manager and retailer based in China, today reported its financial results for the third quarter ended September 30, 2012.
Total sales for the quarter were $69.3 million, an increase of 29.1% compared to $53.7 million in the third quarter of last year. This increase was primarily attributable to increased sales in our retail business as well as our wholesale business.
Retail sales for the quarter from LA GO GO, the Company’s branded retail division, increased 109.5% to $24.4 million, compared to $11.6 million last year. This increase was primarily due to the increase in new stores opened and same store sales. Ever-Glory had 644 LA GO GO stores as of September 30, 2012, compared to 421 LA GO GO stores as of September 30, 2011. Currently, there are LA GO GO stores in more than 20 provinces in China.
Wholesale sales generated from the Company’s wholesale business for the quarter increased 6.8% to $44.9 million, compared to $42.0 million last year. This increase was primarily attributable to increased sales in the United Kingdom and Japan.
Total gross profit for the quarter was $15.3 million, or 22.1% of total sales, compared to $11.2 million, or 20.9% of total sales last year.
Selling expenses for the quarter increased 102.2% to $8.6 million compared to $4.3 million last year. As a percentage of sales, selling expenses increased 450 basis points to 12.4% compared to 7.9% last year. The increase was attributable to the increased number of stores, leading to increased numbers of retail employees and increased average salaries, as well as the increased store decoration and marketing expenses associated with the promotion of the LA GO GO brand.
General and administrative expenses for the quarter increased 20.6% to $4.2 million compared to $3.4 million last year. As a percentage of sales, general and administrative expenses decreased 40 basis points to 6.0% compared to 6.4% last year. The decrease was attributable to the increase in sales.
Income from operations for the quarter decreased 26.5% to $2.6 million compared to $3.5 million last year as a result of increased selling expenses for our retail business
For the third quarter, net income was $2.3 million, or $0.15 per diluted share, a decrease of 15.9% from $2.7 million, or $0.18 per diluted share in the third quarter of 2011.
Balance Sheet and Cash Flow
As of September 30, 2012, Ever-Glory had approximately $10.4 million of cash and cash equivalents, compared to approximately $8.8 million as of December 31, 2011. Ever-Glory had working capital of approximately $39.4 million as of September 30, 2012, and outstanding bank loans of approximately $38.6 million as of September 30, 2012.
Business Outlook
For the fourth quarter of 2012, Every-Glory anticipates total net sales in the range of $70 to $90 million and net income in the range of $3.6 to $5.0 million. For full year 2012, Every-Glory anticipates total net sales in the range of $230 to $260 million and net income in the range of $9.5 to $12 million. The full year revenue forecast is comprised of $140 to $160 million in anticipated wholesale revenue and $90 to $100 million in anticipated revenue from retail operations.
About Ever-Glory International Group, Inc.
Based in Nanjing, China, Ever-Glory International Group, Inc. is a leading apparel supply chain manager and retailer in China. Ever-Glory is the first Chinese apparel Company listed on the American Stock Exchange (now called NYSE MKT), and has a focus on middle-to-high grade casual wear, outerwear, and sportswear brands. Ever-Glory maintains global strategic partnerships in Europe, the United States, Japan and China, conducting business with several well-known brands and retail chain stores. In addition, Ever-Glory operates its own domestic chain of retail stores known as “LA GO GO”.
Conference Call
The Company will hold a conference call today at 8:00 a.m. Eastern Time which will be hosted by Edward Yihua Kang, Chairman of the Board, President, and CEO, and Jason Jiansong Wang, Chief Financial Officer. Listeners can access the conference call by dialing # 1-719-325-2473 and referring to the confirmation code 9757142. The conference call will also be broadcast live over the Internet and can be accessed at the Company’s web site at the following URL: http://www.everglorygroup.com.
A replay of the call will be available from 11:00 a.m. November 12, 2012 through November 17, 2012 Eastern Time by calling # 1-858-384-5517; pin number: 9757142.
Cautionary Note Regarding Forward-Looking Statements
Certain statements in this release and other written or oral statements made by or on behalf of Ever-Glory International Group, Inc. (the “Company”) are “forward looking statements” within the meaning of the federal securities laws. Statements regarding future events and developments and the Company’s future performance, as well as management’s expectations, beliefs, plans, estimates or projections relating to the future, are forward-looking statements within the meaning of these laws. The forward looking statements are subject to a number of risks and uncertainties including, without limitation, market acceptance of the Company’s products and offerings, development and expansion of the Company’s wholesale and retail operations, the Company’s continued access to capital, currency exchange rate fluctuation and other risks and uncertainties. The actual results the Company achieves (including, without limitation, the results stemming from the future implementation of the Company’s strategies and the revenue, net income and new retail store projections set forth herein) may differ materially from those contemplated by any forward-looking statements due to such risks and uncertainties (many of which are beyond the Company’s control). These statements are based on management’s current expectations and speak only as of the date of such statements. Readers should carefully review the risks and uncertainties described in the Company’s latest Annual Report on Form 10-K and other documents that the Company files from time to time with the U.S. Securities and Exchange Commission. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
Contact Information
Company Contact
Yanhua Huang
Tel: +86-25-5209-6875
EVER-GLORY INTERNATIONAL GROUP, INC. AND SUBSDIARIES |
|||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME |
|||||||||||||||||
FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2012 AND 2011 (UNAUDITED) |
|||||||||||||||||
Three months ended |
Nine months ended |
||||||||||||||||
September 30, |
September 30, |
||||||||||||||||
2012 |
2011 |
2012 |
2011 |
||||||||||||||
NET SALES |
$ |
69,269,905 |
$ |
53,673,933 |
$ |
169,691,109 |
$ |
149,805,810 |
|||||||||
COST OF SALES |
53,941,736 |
42,478,209 |
129,173,371 |
119,141,327 |
|||||||||||||
GROSS PROFIT |
15,328,169 |
11,195,724 |
40,517,738 |
30,664,483 |
|||||||||||||
OPERATING EXPENSES |
|||||||||||||||||
Selling expenses |
8,608,695 |
4,257,401 |
21,409,222 |
11,613,276 |
|||||||||||||
General and administrative expenses |
4,152,162 |
3,443,713 |
11,355,568 |
9,772,868 |
|||||||||||||
Total Operating Expenses |
12,760,857 |
7,701,114 |
32,764,790 |
21,386,144 |
|||||||||||||
INCOME FROM OPERATIONS |
2,567,312 |
3,494,610 |
7,752,948 |
9,278,339 |
|||||||||||||
OTHER (EXPENSES) INCOME |
|||||||||||||||||
Interest income |
360,001 |
214,814 |
970,221 |
361,688 |
|||||||||||||
Interest expense |
(449,413) |
(411,206) |
(1,454,157) |
(932,381) |
|||||||||||||
Change in fair value of derivative liability |
91,000 |
15,500 |
381,800 |
345,800 |
|||||||||||||
Other (expenses) income |
(130,359) |
36,058 |
105,954 |
60,192 |
|||||||||||||
Total Other (Expenses) Income |
(128,771) |
(144,834) |
3,818 |
(164,701) |
|||||||||||||
INCOME BEFORE INCOME TAX EXPENSE |
2,438,541 |
3,349,776 |
7,756,766 |
9,113,638 |
|||||||||||||
INCOME TAX EXPENSE |
(164,609) |
(646,793) |
(1,010,475) |
(1,539,790) |
|||||||||||||
NET INCOME |
2,273,932 |
2,702,983 |
6,746,291 |
7,573,848 |
|||||||||||||
Foreign currency translation (loss) gain |
(192,935) |
332,262 |
7,066 |
1,048,757 |
|||||||||||||
COMPREHENSIVE INCOME |
$ |
2,080,997 |
$ |
3,035,245 |
$ |
6,753,357 |
$ |
8,622,605 |
|||||||||
EARNINGS PER SHARE |
|||||||||||||||||
Basic and diluted |
$ |
0.15 |
$ |
0.18 |
$ |
0.46 |
$ |
0.51 |
|||||||||
Weighted average number of shares outstanding |
|||||||||||||||||
Basic and diluted |
14,765,942 |
14,758,944 |
14,765,568 |
14,756,122 |
Escalon® (ESMC) and Modernizing Medicine, Inc. Announce Partnership
Escalon® Medical Corp. and Modernizing Medicine, Inc. Announce Partnership for Offering Integrated EMR and Image Management
WAYNE, Pa., Nov. 9, 2012 /PRNewswire/ — Escalon® Medical Corp. (Nasdaq: ESMC) today announced the partnering of its Sonomed Escalon™ group with Modernizing Medicine, Inc. to provide cloud-based end-to-end electronic medical records (EMR) and image management solutions for ophthalmic practices. Seamless integration of Sonomed Escalon’s AXIS™ image management software and Modernizing Medicine’s Electronic Medical Assistant™ EMA Ophthalmology EMR solution provides complete patient management from a single merged solution, from coding and prescribing at the touch of a button to powerful exam image review tools, and more. The companies will introduce the integrated solutions at the American Academy of Ophthalmology’s Annual Meeting in Chicago, IL November 10-13, 2012.
“EMA Ophthalmology is a cloud-enabled EMR that is fast becoming one of the industry’s leading solutions due to its power, flexibility, ease of use, and focus on improving clinical efficiency,” noted Matthew Carnevale, Sonomed Escalon’s Chief Technology Officer. “Now added to that is unparalleled exam image review capabilities and complete integration with nearly any diagnostic imaging device.”
“We are excited to save doctors even more time with the addition of AXIS’ advanced integration of diagnostic images to patient records stored in EMA,” said James Brooks, Executive Vice President of Sales & Marketing at Modernizing Medicine. “Sonomed Escalon is an ideal partner for Modernizing Medicine since both companies have demonstrated a commitment to making accessible mobile offerings, especially on the iPad platform. With the combined AXIS EMA Ophthalmology solution, ophthalmologists can now both review diagnostic images such as OCT, fluorescein angiography, color fundus, and others, and interpret the results of the exam directly on an iPad.”
The partnership allows Modernizing Medicine and Escalon to offer their respective products either as stand-alone solutions or as an integrated package, depending upon the needs of particular clients. For more information, visit www.modmed.com or www.sonomedescalon.com, or meet both companies at the American Academy of Ophthalmology’s Annual Meeting, booth #2771 for Modernizing Medicine and #3238 for Sonomed Escalon.
About Modernizing Medicine
Modernizing Medicine is delivering the next generation of electronic medical records (EMR) technology for the healthcare industry. Its Electronic Medical Assistant™ (EMA) is a cloud-based specialty-specific EMR with a massive library of built-in medical content, designed to save physicians time. Available as a native iPad application or from any web-enabled Mac or PC, EMA adapts to each provider’s unique style of practice and is designed to interface with over 400 different practice management systems. Today, Modernizing Medicine provides specialty-specific offerings for the dermatology, ophthalmology, optometry and plastic surgery markets, and to over 700 practices across the country.
About Escalon Medical Corp.
Founded in 1987, Escalon Medical Corp. (www.escalonmed.com) develops markets and distributes ophthalmic diagnostic and surgical products. The Company seeks to utilize strategic partnerships to enhance its development programs and also seeks acquisitions to further expand its product offering to achieve critical mass and better leverage the Company’s distribution capabilities, although such partnerships or acquisitions may or may not occur. The Company has headquarters in Wayne, Pennsylvania and operations in Long Island, New York, New Berlin, Wisconsin and Stoneham, Massachusetts.
Note: This press release contains statements that are considered forward-looking under the Private Securities Litigation Reform Act of 1995, including statements about the Company’s future prospects. These statements are based on the Company’s current expectations and are subject to a number of uncertainties and risks, and actual results may differ materially. The uncertainties and risks include whether the Company is able to:
- implement its growth and marketing strategies, improve upon the operations of the Company business units, including the ability to make acquisitions and the integration of any acquisitions it may undertake, if any, of which there can be no assurance,
- grow our remaining ophthalmic business unit,
- implement cost reductions,
- generate cash,
- identify, finance and enter into business relationships and acquisitions.
Other factors include uncertainties and risks related to:
- new product development, commercialization, manufacturing and market acceptance of new products,
- marketing acceptance of existing products in new markets,
- research and development activities, including failure to demonstrate clinical efficacy,
- delays by regulatory authorities, scientific and technical advances by the Company or third parties,
- introduction of competitive products,
- ability to reduce staffing and other costs and retain benefit of prior reductions
- third party reimbursement and physician training, and
- general economic conditions.
Further information about these and other relevant risks and uncertainties may be found in the Company’s report on Form 10- K for year ended June 30, 2012, and its other filings with the Securities and Exchange Commission, all of which are available from the Securities and Exchange Commission as well as other sources.
China Shen Zhou (SHZ) Redeems Preferred Stock
BEIJING, Nov. 09, 2012 /PRNewswire-FirstCall/ — China Shen Zhou Mining & Resources, Inc. (“China Shen Zhou”, or the “Company”) (NYSE Amex: SHZ), a company engaged in the exploration, development, mining and processing of fluorite, barite, zinc, copper, and other nonferrous metals in China, today announced that the Company has successfully entered into agreements with a group of institutional investors to redeem, and fulfill its dividend obligations with respect to 1,332 shares of Convertible Preferred Stock using $398,519.46 in cash, $391,764.48 of which will be used to redeem the Convertible Preferred Stock.
On March 26, 2012, the Company completed an offering of Series A Convertible Preferred Stock for gross proceeds of $5.0 million. The Company issued 5,000 shares of Series A Convertible Preferred Stock and warrants to purchase 1,960,785 shares of common stock of the Company at $2.05. The proceeds were used for the completion of the acquisition of several fluorite mines and processing plants as well as necessary infrastructure upgrades.
Per the terms of the Series A Convertible Preferred Stock, the Preferred Stock’s conversion price is subject to adjustment according to market price. The Company believes that the redemption with cash will disable the conversion of these shares of Preferred Stock to common stock and reduce dilution to other common stock shareholders.
Despite the current economic climate adversely affecting many resource companies in China whose important customers are steel and aluminum producers, the Company is making its best efforts to grow business, optimize cash flow and improve shareholder value.
Regarding the prior announcement of the Company from November 7th, the Company remains confident that it can provide the NYSE MKT LLC (the “Exchange”) with a satisfactory plan by November 30, and regain its compliance within the timeframe set forth by the Exchange.
About China Shen Zhou Mining & Resources, Inc.
China Shen Zhou Mining & Resources, Inc., through its subsidiaries, is engaged in the exploration, development, mining, and processing of fluorite, barite and nonferrous metals such as zinc, lead and copper in China. The Company has the following principal areas of interest in China: (a) fluorite extraction and processing in the Sumochaganaobao region of Inner Mongolia; (b)fluorite and barite extraction and processing in the Wuchuan County of Guizhou province (c)fluorite and barite extraction and processing in the Yanhe County of Guizhou province.(d)fluorite extraction and processing in Jingde County, Anhui Province; (e) zinc/copper/lead processing in Wulatehouqi of Inner Mongolia; and (f) zinc/copper exploration, mining and processing in Xinjiang. For more information, please visit http://www.chinaszmg.com/.
Safe Harbor Statement
This press release may include certain statements that are not descriptions of historical facts, but are forward-looking statements. Forward-looking statements can be identified by the use of forward-looking terminology such as “will”, “believes”, “expects” or similar expressions. These forward-looking statements may also include statements about our proposed discussions related to our business or growth strategy, which is subject to change. Such information is based upon expectations of our management that were reasonable when made but may prove to be incorrect. All of such assumptions are inherently subject to uncertainties and contingencies beyond our control and upon assumptions with respect to future business decisions, which are subject to change. We do not undertake to update the forward-looking statements contained in this press release. For a description of the risks and uncertainties that may cause actual results to differ from the forward-looking statements contained in this press release, see our most recent Annual Report filed with the Securities and Exchange Commission (SEC) on Form 10-K, and our subsequent SEC filings. Copies of filings made with the SEC are available through the SEC’s electronic data gathering analysis retrieval system (EDGAR) at http://www.sec.gov.
Contact Information
Min Liu
Investor Relations
Grayling
Tel: +1-646-284-9413
min.liu@grayling.com
Shiwei Yin
Grayling
Tel: +1-646-284-9474
shiwei.yin@grayling.com
Advanced Photonix (API) Receives $5.9 Million Telecom 100G Commitment
Picometrix®, LLC, an Advanced Photonix® company (NYSE MKT: API), announced today that it has secured a $5.9 million commitment for calendar year 2013 for its industry leading 100 gigabit per second (Gb/s or G) and 40G high-speed optical receivers from a leading telecommunications network equipment customer. The annual commitment is estimated at more than $5.2 million for the Company’s industry leading 100G family of coherent receivers for DP-QPSK modulation and $760K for the company’s 40G receivers for DPSK modulation, both of which are used in long-haul dense wavelength division multiplexing (DWDM) systems. Shipments are expected to begin in the Company’s 4th quarter of FY2013.
The state of the art CR-100A 100G optical receiver utilizes the company’s patented photodiode arrays, an optical photonic integrated circuit (PIC), and high-speed linear amplifiers to deliver industry leading performance. The product comes in the industry standard CCRx™ Multisource Agreement (MSA) form factor, is consistent with OIF, and supports data rates up to 128 Gb/s. The CR-100A exemplifies the company’s continued technology leadership in high-speed optical receivers (HSOR) for telecom applications. Picometrix offers the industry’s most complete line of 100G and 40G HSOR solutions for both client-side and line-side equipment.
“We are pleased to have received a substantial increase in commitment for 2013 from our lead customer, further solidifying our industry leading position in 100G coherent receivers. This further validates our success in developing optical receivers that support our network equipment customers’ deployment of next generation optical networks to global telecom service providers,” said Robin Risser, COO of API. “This agreement demonstrates that 100G coherent network deployment is in the early growth stage as service providers continue to selectively spend on capacity expansion, despite a weak macro-economic environment, to accommodate traffic growth driven by video, mobile video, the proliferation of network-attached devices, and social networking applications that are enabling consumers to access bandwidth-intensive content anytime and anywhere over fixed and wireless networks. We believe that 100G networks are in the very early stage of deployment and we are committed to developing and supplying state of the art and products to support this fast growing market.”
About Advanced Photonix, Inc.
Advanced Photonix, Inc.® (NYSE MKT: API) is a leading supplier with a broad offering of optoelectronic products to a global customer base. We provide optoelectronic solutions, high-speed optical receivers and terahertz instrumentation for telecom, homeland security, military, medical and industrial markets. With our patented technology and state-of-the-art manufacturing we offer industry leading performance, exceptional quality, and high value-added products to our OEM customer base. For more information visit us on the web at www.advancedphotonix.com.
The information contained herein includes forward looking statements that are based on assumptions that management believes to be reasonable but are subject to inherent uncertainties and risks including, but not limited to, unforeseen technological obstacles which may prevent or slow the development and/or manufacture of new products; potential problems with the integration of the acquired company and its technology and possible inability to achieve expected synergies; obstacles to successfully combining product offerings and lack of customer acceptance of such offerings; limited (or slower than anticipated) customer acceptance of new products which have been and are being developed by the Company; and a decline in the general demand for optoelectronic products; and the risk factors listed from time to time in the Company’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings. The Company assumes no obligation to update forward-looking statements contained in this release to reflect new information or future events or developments. API-G
CAMAC Energy (CAK) to Host Third Quarter 2012 Results Conference Call
HOUSTON, Oct. 26, 2012 /PRNewswire/ — CAMAC Energy Inc. (NYSE MKT: CAK), a U.S.-based energy company engaged in the exploration, development and production of oil and gas in Africa, today announced that it will be hosting its third quarter 2012 results conference call at 11:00 a.m. Eastern Time (10:00 a.m. Central Time) on Friday, November 9, 2012. Hosting the call will be Dr. Kase Lawal, Chairman and CEO and Earl W. McNiel, Interim Chief Financial Officer.
Earnings Call details – |
|
Date: |
Friday, November 9, 2012 |
Time: |
11:00 a.m. ET / 10:00 a.m. CT / 9:00 AM MT / 8:00 AM PT |
Participate: |
The call can be accessed live over the telephone by dialing: |
Listen only: |
A live webcast of the call will be available at http://www.videonewswire.com/event.asp?id=88662 |
Replay: |
The webcast replay will be available until December 12, 2012 at 9:00 a.m. ET using Conference Number 10020244. The webcast will also be archived on the Company’s website shortly following the call for approximately 30 days. |
About CAMAC Energy Inc.
CAMAC Energy Inc. (NYSE MKT: CAK) is a U.S.-based energy company engaged in the exploration, development and production of oil and gas. The Company’s principal assets include interests in OML 120 and OML 121, offshore oil and gas leases in deep water Nigeria which include the currently producing Oyo Oilfield, and six recently acquired exploration blocks in Kenya and Gambia. The Company is currently pursuing further additions to its exploration portfolio in East and West Africa. The Company was founded in 2005 and has offices in Houston, Texas and Lagos, Nigeria.
Contacts
Media:
CAMAC Energy Inc.
Cristy Taylor, 713-797-2940
PR@camacenergy.com
or
Investor Relations:
Jason Lee
832-209-1419
IR@camacenergy.com
Liviakis Financial Communications, Inc.
John Liviakis, CEO
415-389-4670
Cambium (ABCD) Announces Date for Q3 2012 Earnings Call
DALLAS, Oct. 22, 2012 /PRNewswire/ — Cambium Learning Group, Inc. (Nasdaq: ABCD, the “Company”), a leading educational company focused primarily on serving the needs of at-risk and special student populations, today announced it will hold a conference call to discuss 2012 third quarter financial results on Thursday, November 8, 2012, at 5:00 p.m. Eastern Time. The call will be based on unaudited results through September 30, 2012.
(Logo: http://photos.prnewswire.com/prnh/20100129/CLGROUPLOGO)
To listen to the Company’s upcoming conference call, please dial (800) 860-2442 and reference “Cambium Learning” at 5:00 p.m. Eastern Time on Thursday, November 8, 2012. The call will be recorded and archived until Friday, December 7, 2012, and can be replayed by calling (877) 344-7529 and entering ID#10019972. The conference call will also be Webcast and available on the Company’s Website at http://cambiumlearning.investorroom.com/events.
About Cambium Learning Group, Inc.
Cambium Learning® Group (Nasdaq: ABCD) is the leading educational company focused primarily on serving the needs of at-risk and special student populations. The company is comprised of three business units: Voyager Learning provides comprehensive print and online intervention solutions, professional development, and school turnaround offerings and includes Lincoln National Academy, Class.com, and Voyager Education Services; Sopris Learning is known for supplemental solutions, including assessment, supplemental intervention, positive behavior supports and professional development; and Cambium Learning Technologies develops instructional and assistive technology and represents IntelliTools®, Kurzweil Educational Systems®, Learning A–Z, and ExploreLearning. Cambium Learning Group is committed to providing evidence-based support and expert professional services to empower educators and raise the achievement levels of all students. Learn more at www.cambiumlearning.com.
Investor Contact:
Chris Cleveland
Cambium Learning Group, Inc.
214.932.9474
chris.cleveland@cambiumlearning.com
MTS (MTSL) Announces Third Quarter 2012 Financial Results
Year over Year Quarterly Revenues Increased 12% and Operating Income Increased 180%; Generated $1.3 Million of Free Cash Flow During the First Nine Months of 2012; The Company Recorded a Non-Recurring Charge of $0.45 Million Due to a Tax Ruling
RA’ANANA, Israel, November 8, 2012 /PRNewswire/ —
MTS – Mer Telemanagement Solutions Ltd. (Nasdaq Capital Market: MTSL), a global provider of MVNE services and telecommunications expense management (TEM) services and solutions, today announced its financial results for the third quarter of 2012.
Revenues for the third quarter of 2012 were $3.4 million, compared with $3.0 million in revenues during the same quarter last year and revenues of $3.3 million in the second quarter of 2012. The Company’s operating profit was $692,000 in the third quarter of 2012 compared to an operating profit of $244,000 for the third quarter of 2011 and $517,000 in the second quarter of 2012. On a non-GAAP basis, excluding the non-recurring tax charge related to a court ruling, net income for the third quarter of 2012 was $691,000 or $0.15 per diluted share, compared with net income of $226,000 or $0.05 per diluted share in the third quarter of 2011 and $460,000 or $0.10 per diluted share in the second quarter of 2012. Net income for the third quarter, after a $446,000 non-recurring tax charge, was $245,000 or $0.05 per diluted share, compared with net income of $226,000 or $0.05 per diluted share in the third quarter of 2011 and $460,000 or $0.10 per diluted share in the second quarter of 2012.
Revenues for the nine months period ended September 30, 2012 were $9.6 million, compared with $8.8 million for the comparable period in 2011. The Company’s operating profit was $1.5 million for the nine months period ended September 30, 2012 compared to an operating profit of $439,000 for the same period last year. On a non-GAAP basis, excluding the non-recurring tax charge related to the court ruling, net income for the nine months ended September 30, 2012 was $1.5 million or $0.32 per diluted share, compared with net income of $588,000 or $0.13 per diluted share in the comparable period of 2011. Net income for the nine months ended September 30, 2012 was $1.0 million or $0.22 per diluted share, compared with net income of $588,000 or $0.13 per diluted share in the comparable period in 2011.
Net income for the third quarter and for the nine months period ending September 30, 2012 was negatively affected by a non-recurring tax charge of approximately $446,000, as a result of a court ruling relating to the Company’s appeal of a tax ruling of the Israeli tax authorities that was issued with respect to the 1997 to 1999 period. The Company has not as yet received an assessment from the tax authorities.
As of September 30, 2012, we had cash and marketable securities of $4.6 million as compared to $3.4 million as at December 31, 2011. During the nine month period ended September 30, 2012 we had positive operating cash flow of $1.3 million, as compared to positive operating cash flow of $800,000 during the nine month period ended September 30, 2011.
“Our third quarter results represent continued improvements in our financial results and indicators as a result of our efforts to develop our Mobile Virtual Network Enabler (MVNE) activity and the Telecom Expense Management opportunities through partners, new customer acquisitions and expanding our existing customer base” said Eytan Bar, CEO of MTS.
“As we previously announced, we extended our largest existing MVNO services contract, with minimum revenues of $3.6 million during 2013. In addition, following last quarter’s announcement that we signed a new managed service agreement, we recently were able to successfully launch our MVNE service with this new MVNO in the US. The Company sees other opportunities in this market and we are working diligently to turn them into new contracts. We are looking forward to improving both our top and bottom line performance,” concluded Mr. Bar.
Non-GAAP Financial Measures
This release includes non-GAAP net income and diluted earnings per share financial measures. These non-GAAP measures exclude a non-recurring tax charge.
The Company’s management believes that the presentation of non-GAAP measures provides useful information to investors and management regarding financial and business trends relating to the Company’s financial condition and results of operations.
These non-GAAP financial measures are not in accordance with, or an alternative for, generally accepted accounting principles. In addition, these non-GAAP financial measures are not based on any comprehensive set of accounting rules or principles. The Company believes that non-GAAP financial measures have limitations in that they do not reflect all of the amounts associated with the Company’s results of operations as determined in accordance with GAAP and that these measures should only be used to evaluate the Company’s results of operations in conjunction with the corresponding GAAP measures. Please refer to the reconciliation of GAAP to Non-GAAP table below.
About MTS
Mer Telemanagement Solutions Ltd. (MTS) is a worldwide provider of innovative products and services for comprehensive telecom expense management (TEM) and enterprise mobility management (EMM) solutions used by enterprises, telecom billing solutions used by telecommunication service providers, and mobile virtual network operators and enablers (MVNO/MVNE) solutions used by mobile service providers.
Headquartered in Israel, MTS markets its solutions through wholly owned subsidiaries in the United States, Hong Kong and The Netherlands as well as through OEM partnerships with Siemens, Phillips, NEC and other vendors. MTS shares are traded on the NASDAQ Capital Market (symbol MTSL). For more information please visit the MTS web site: http://www.mtsint.com.
Certain matters discussed in this news release are forward-looking statements that involve a number of risks and uncertainties including, but not limited to, risks in product development plans and schedules, rapid technological change, changes and delays in product approval and introduction, customer acceptance of new products, the impact of competitive products and pricing, market acceptance, the lengthy sales cycle, proprietary rights of the Company and its competitors, risk of operations in Israel, government regulations, dependence on third parties to manufacture products, general economic conditions and other risk factors detailed in the Company’s filings with the United States Securities and Exchange Commission.
CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
September December 30, 31, 2012 2011 ASSETS CURRENT ASSETS: Cash and cash equivalents $ 4,516 $ 3,269 Restricted cash 146 45 Restricted marketable securities 123 127 Trade receivables, net 751 854 Prepaid expenses and other assets 152 93 Total current assets 5,688 4,388 LONG-TERM ASSETS: Severance pay fund 696 619 Other long term assets 35 37 Total long-term assets 731 656 PROPERTY AND EQUIPMENT, NET 201 161 OTHER ASSETS: Goodwill 3,479 3,479 Other intangible assets, net 809 1,050 Total other assets 4,288 4,529 Total assets $ 10,908 $ 9,734
CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
September 30, December 31, 2012 2011 LIABILITIES AND SHAREHOLDERS' EQUITY CURRENT LIABILITIES: Trade payables $ 255 $ 326 Accrued expenses and other liabilities 2,694 2,354 Deferred revenues 1,690 2,025 Liabilities of discontinued operations 435 435 Total current liabilities 5,074 5,140 LONG-TERM LIABILITIES - Accrued severance pay 835 762 COMMITMENTS AND CONTINGENT LIABILITIES SHAREHOLDERS' EQUITY: Share capital 13 13 Additional paid-in capital 19,903 19,773 Treasury shares (29) (29) Accumulated other comprehensive income 3 (19) Accumulated deficit (14,891) (15,906) Total shareholders' equity 4,999 3,832 Total liabilities and shareholders' equity $ 10,908 $ 9,734
CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share and per share data)
Nine months ended Three months ended September 30, September 30, 2012 2011 2012 2011 Revenues: Product sales $ 2,622 $ 2,933 $ 870 $ 926 Services 7,026 5,911 2,515 2,083 Total revenues 9,648 8,844 3,385 3,009 Cost of revenues: Product sales 887 836 269 255 Services 2,458 1,982 846 662 Total cost of revenues 3,345 2,818 1,115 917 Gross profit 6,303 6,026 2,270 2,092 Operating expenses: Research and development, net of grants from the OCS 1,003 1,445 299 500 Selling and marketing 1,600 1,465 557 439 General and administrative 2,206 2,267 717 909 Total operating expenses 4,809 5,587 1,573 1,848 Operating profit 1,494 439 697 244 Financial income (expenses), net (20) 79 1 (11) Capital gain on sale of investment - 78 - - Income before taxes on income 1,474 596 698 233 Tax on income (benefit), net 459 8 453 7 Net income $ 1,015 $ 588 $ 245 $ 226 Net Income per share: Basic net income per Ordinary share $ 0.23 $ 0.13 $ 0.05 $ 0.05 Diluted net income per Ordinary share $ 0.22 0.13 $ 0.05 $ 0.05 Weighted average number of Ordinary shares used in computing basic net income per share 4,462,807 4,459,057 4,470,306 4,459,057 Weighted average number of Ordinary shares used in computing diluted net income per share 4,525,694 4,459,057 4,533,193 4,459,057
RECONCILIATION OF GAAP TO NON-GAAP RESULTS
U.S. dollars in thousands (except share and per share data)
Nine months ended Three months ended September 30, September 30, 2012 2011 2012 2011 GAAP Net Income 1,015 588 245 226 Tax charge related to court ruling 446 - 446 - Non-GAAP Net income $ 1,461 $ 588 $ 691 $ 226 Net Income per share: GAAP diluted net income per Ordinary share $ 0.22 $ 0.13 $ 0.05 $ 0.05 Non-GAAP diluted net income per Ordinary share $ 0.32 $ 0.13 $ 0.15 $ 0.05 Weighted average number of Ordinary shares used in computing GAAP diluted net income per share 4,525,694 4,459,057 4,533,193 4,459,057 Weighted average number of Ordinary shares used in computing Non-GAAP diluted net income per share 4,525,694 4,459,057 4,533,193 4,459,057
Company Contact:
Alon Mualem
CFO
Tel: +972-9-7777-540
Email: Alon.Mualem@mtsint.com
Mannatech (MTEX) Announces Upcoming Distribution into Hong Kong
Mannatech, Incorporated (NASDAQ: MTEX), the leading innovator and provider of nutritional supplements based on Real Food Technology® solutions, announced today the initiation of order shipments into Hong Kong from its existing Taiwan operation. Implementation is planned to be completed by the end of 2012.
This step serves as Mannatech’s first toward a formal opening of the Hong Kong market. While dates for opening have not yet been set, this newest development exhibits Mannatech’s strategic commitment to international growth. According to the World Federation of Direct Selling Associations, 2011 retail sales in Hong Kong from direct sales companies reached $406 million in U.S. currency, with more than 155,000 identified independent distributors.
“We are excited about both the short-term potential of this new cross-border strategy and the long-term possibilities of the Hong Kong market for Mannatech,” said Dr. Robert Sinnott, Mannatech’s CEO and Chief Science Officer. “Our goal is to nourish the world with Mannatech’s Real Food Technology supplementation, and to expand the reach of our global seamless compensation plan for those who choose to champion our cause. Expanding into this emerging Asian market is a promising and exciting step for our company’s future.”
Al Bala, Executive Vice President of Global Sales & Marketing, added, “We’re not just excited about the opening of this new market, but also what it means for our existing markets. For example, we’ve seen impressive, ongoing growth from our North American Chinese base of Associates. Creating this opportunity in Hong Kong should only further support their efforts in building a global business with Mannatech.”
Individuals interested in Mannatech’s products or exploring its business opportunity are encouraged to learn more at Mannatech.com.
About Mannatech
Mannatech, Incorporated, develops high-quality health, weight and fitness, and skin care products that are based on the solid foundation of nutritional science and development standards. Mannatech is dedicated to its platform of Social Entrepreneurship based on the foundation of promoting, aiding and optimizing nutrition where it is needed most around the world. Mannatech’s proprietary products are available through independent sales Associates around the globe including the United States, Canada, South Africa, Namibia, Australia, New Zealand, Austria, Denmark, Germany, Norway, Sweden, the Netherlands, the United Kingdom, Japan, Taiwan, Singapore, Estonia, Finland, the Republic of Ireland, Czech Republic, the Republic of Korea and Mexico. For more information, visit Mannatech.com.
Please note: This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by use of phrases or terminology such as “intend” or other similar words or the negative of such terminology. Similarly, descriptions of Mannatech’s objectives, strategies, plans, goals or targets contained herein are also considered forward-looking statements. Mannatech believes this release should be read in conjunction with all of its filings with the United States Securities and Exchange Commission and cautions its readers that these forward-looking statements are subject to certain events, risks, uncertainties and other factors. Some of these factors include, among others, Mannatech’s inability to attract and retain Associates and Members, increases in competition, litigation, regulatory changes and its planned growth into new international markets. Although Mannatech believes that the expectations, statements and assumptions reflected in these forward-looking statements are reasonable, it cautions readers to always consider all of the risk factors and any other cautionary statements carefully in evaluating each forward-looking statement in this release, as well as those set forth in its latest Annual Report on Form 10-K and Quarterly Report on Form 10-Q, and other filings filed with the United States Securities and Exchange Commission, including its current reports on Form 8-K. All of the forward-looking statements contained herein speak only as of the date of this release.
Palatin Tech (PTN) Reports Positive Results for Female Sexual Dysfunction Trial
Palatin Technologies Reports Positive Results for Phase 2B Bremelanotide Female Sexual Dysfunction Trial
Statistical Significance Achieved for Primary Endpoint and Key Secondary Endpoints Teleconference and Webcast to be held at 10:00 a.m. ET on Thursday, November 8, 2012
CRANBURY, N.J., Nov. 8, 2012 /PRNewswire/ — Palatin Technologies, Inc. (NYSE MKT: PTN) today reported positive top-line results, including the successful achievement of statistical significance for the primary endpoint and key secondary endpoints in its Phase 2B clinical trial evaluating the efficacy and safety of bremelanotide for the treatment of female sexual dysfunction (FSD).
The data demonstrate that women taking bremelanotide showed statistically significant increases in the number of Satisfying Sexual Events (SSEs) and also showed statistically significant improved measures of overall sexual functioning and distress related to sexual dysfunction, compared with placebo.
The primary endpoint data analysis of 327 pre-menopausal women with female sexual arousal disorder (FSAD), hypoactive sexual desire disorder (HSDD), or a combination of both disorders, the most common types of FSD, shows a clinically meaningful and statistically significant improvement (p=0.018) in the number of SSEs in women taking bremelanotide doses (mean change from 1.6 at baseline increasing to 2.4; pooled 1.25 mg and 1.75 mg doses) versus placebo (mean change from 1.7 at baseline increasing to 1.9) over the study period, resulting in a 50% increase in SSEs with bremelanotide versus 12% with placebo.
“We are extremely pleased to report the successful completion of this trial, which achieved statistical significance in our primary endpoint and key secondary endpoints using independently developed and validated measurement tools. Importantly, we met the objectives of the trial which demonstrated excellent safety and efficacy of the drug and identified doses for advancement into Phase 3 trials and activities” stated Carl Spana, Ph.D., President and CEO of Palatin. “Our next steps are to continue to compile and analyze additional data, to start the preparation process for an end-of-Phase 2 meeting with the FDA, and to further our discussions with potential collaboration partners.”
In addition to meeting the primary endpoint, preliminary analysis of key secondary endpoints showed clinically meaningful and statistically significant improvement in patients who received bremelanotide vs. placebo (mean change from baseline to end of study; pooled 1.25 mg and 1.75 mg bremelanotide doses):
- Improved overall sexual function, as measured by the Female Sexual Function Index (FSFI). The FSFI is a 19-item questionnaire which provides for an additional measurement of changes over a longer recall period.
- FSFI total score improvement (mean change of 3.55 vs. 1.88, p=0.0017)
- Reduction in distress related to sexual dysfunction, as measured by the Female Sexual Distress Scale-DAO (FSDS-DAO). The FSDS-DAO 15-item questionnaire is designed to assess and quantify the change in personal distress associated with female sexual dysfunction.
- FSDS-DAO total score improvement (mean change of -11.1 vs. -6.8, p=0.036)
The primary endpoint and key secondary endpoints measurement period was defined as reported results during the last four weeks of treatment compared to the reported results during the baseline period. For all endpoints, the pre-specified statistical analysis as agreed to with the FDA was the pooled data for the 1.25 mg and 1.75 mg doses, compared to placebo.
Data analysis of the individual 0.75 mg, 1.25 mg and 1.75 mg bremelanotide doses each showed clinically meaningful improvement for the primary endpoint and key secondary endpoints, with the 1.75 mg dose achieving statistical significance for the endpoints cited above.
Jeff Edelson, M.D., Chief Medical Officer for Palatin stated, “These data provide an important demonstration of the safety and efficacy of bremelanotide and suggest its potential utility for the treatment of FSD in premenopausal women. Moreover, the trial provides important data that will be instrumental in planning Phase 3 clinical trials and activities. We look forward to working closely with our expert advisors, and the FDA, to identify next steps in the late stage clinical development of this exciting drug.”
“These safety and efficacy trial results are very encouraging and clearly warrant further clinical testing of bremelanotide in this patient population. Despite the pressing need for such treatments, there are presently no FDA approved therapies for the treatment of female sexual disorders, conditions with major negative health impacts on patients,” said Sheryl Kingsberg, Ph.D., Division Chief, OB/GYN Behavioral Medicine, UH Case Medical Center, and a clinical investigator on the study.
Bremelanotide was well-tolerated during the trial. The most common types of treatment-emergent adverse events reported more frequently in the bremelanotide arms were facial flushing, nausea and emesis, which were mainly mild-to-moderate in severity. The study dosed 395 patients. A total of 26 patients discontinued from the study based on predefined blood pressure criteria: these patients were evenly distributed across the placebo and bremelanotide dosing arms. An additional 12 patients discontinued from the study due to adverse events (N=12, Placebo: 2, bremelanotide arms 0.75 mg: 0, 1.25 mg: 4, 1.75 mg: 6). Adverse events that most commonly led to discontinuation were nausea and emesis.
The study was supervised by an independent Data Safety Monitoring Board. No serious adverse events were attributed to bremelanotide during the trial.
Detailed analysis of the data results in this trial will be presented at upcoming medical and scientific conferences and publications. Based on the results of discussions with the FDA and external advisors regarding the results of this trial and further development steps, Phase 3 activities are anticipated to start in the second-half of calendar year 2013.
Study Design
Approximately 400 premenopausal women, diagnosed with female sexual arousal disorder, hypoactive sexual desire disorder or both, were enrolled in the study. Patients were treated for 16 weeks and were randomized to one of four double-blind treatment groups and received placebo or bremelanotide doses of 0.75, 1.25, or 1.75 milligrams.
The trial was a multi-centered, randomized, placebo-controlled, parallel-group dose-ranging trial designed to evaluate the safety and efficacy of three subcutaneous (SC) bremelanotide fixed doses intended for on-demand use in premenopausal females with FSD. The pharmacokinetics of SC bremelanotide was also assessed during this trial.
The objectives of the Phase 2B trial were to demonstrate and identify safe and effective SC doses of bremelanotide and to define endpoint measurements to support transition to Phase 3 clinical studies and activities.
About Female Sexual Dysfunction
Female Sexual Dysfunction (FSD) covers multi-factorial conditions that have anatomical, physiological, medical, psychological and social components. FSD includes four categories: Sexual Desire Disorders (hypoactive sexual desire disorder [HSDD], sexual aversion disorder), Female Sexual Arousal Disorder (FSAD), Female Orgasmic Disorder (FOD), and Sexual Pain Disorders (dyspareunia, vaginismus). To establish a diagnosis of FSD, one or more of these disorders must be associated with personal distress, as determined by the affected women. In the 2008 PRESIDE study (Prevalence of Female Sexual Problems Associated with Distress and Determinants of Treatment Seeking, reference: Obstet Gynecol. 2008 Nov: 112(5):970-8), Shifren and colleagues studied over 30,000 US women, reporting an age – adjusted point prevalence of sexual difficulties causing personal distress in 12% of respondents.
There are no drugs in the United States approved for the treatment of FSD. Bremelanotide is an on-demand treatment for FSD and has the potential to transform the treatment of patients with FSD.
Bremelanotide for Sexual Dysfunction
Palatin is developing subcutaneously administered bremelanotide for the treatment of FSD in premenopausal women diagnosed with FSD. Bremelanotide, which is a melanocortin agonist (a compound which binds to a cell receptor and triggers a response) drug candidate, is a synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone).
Conference Call/Webcast
Palatin will host a conference call and webcast on November 8, 2012 at 10:00 a.m. Eastern Time to discuss the results of its Phase 2B clinical trial in greater detail. Individuals interested in listening to the conference call live can dial 1-888-471-3843 (domestic) or 1-719-325-2491 (international), pass code 1406375. The webcast and replay can be accessed by logging on to the “Investor/Media Center-Webcasts” section of Palatin’s website at http://www.palatin.com. A telephone and webcast replay will be available approximately one hour after the completion of the call. To access the telephone replay, dial 1-888-203-1112 (domestic) or 1-719-457-0820 (international), pass code 1406375. The webcast and telephone replay will be available through November 15, 2012.
About Palatin Technologies
Palatin Technologies, Inc. is a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential. Palatin’s strategy is to develop products and then form marketing collaborations with industry leaders in order to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin’s website at http://www.palatin.com.
Forward-looking Statements
Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc. such as statements about clinical trial results, potential actions by regulatory agencies including the U.S. Food and Drug Administration (FDA), regulatory plans, development programs, proposed indications for product candidates and market potential for product candidates, are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Palatin intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin’s actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements. Palatin’s actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, results of clinical trials, regulatory actions by the FDA and the need for regulatory approvals, Palatin’s ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin’s products, and other factors discussed in Palatin’s periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating for events that occur after the date of this press release.
Arotech Corp. (ARTX) Reports Results for the Third Quarter and First Nine Months, 2012
ANN ARBOR, MI — (Marketwire) — 11/07/12 — Arotech Corporation (NASDAQ: ARTX), a provider of quality defense and security products for the military, law enforcement and homeland security markets, today reported results for the quarter and nine months ended September 30, 2012.
Third Quarter Results
Revenues from continuing operations for the third quarter reached $21.4 million, compared to $21.1 million for the corresponding period in 2011, an increase of 1.4% over the same period last year.
Gross profit from continuing operations for the quarter was $5.0 million, or 23.1% of revenues, compared to $4.1 million, or 19.5% of revenues, for the corresponding period last year, a 3.6 point increase in the gross margin percentage.
Earnings Before Interest, Taxes, Depreciation and Amortization (EBITDA) from continuing operations for the quarter was $1.4 million, compared to $288,000 for the corresponding period of 2011. Arotech believes that information concerning EBITDA enhances overall understanding of its current financial performance. Arotech computes EBITDA, which is a non-GAAP financial measure, as reflected in the table below.
The Company’s net income from continuing operations for the third quarter was $433,000, or $0.03 per share, versus a net loss of $(977,000), or $(0.07) per share, for the corresponding period last year.
The Company’s net income from all operations, including discontinued operations, for the third quarter was $498,000, or $0.03 per share, versus a net loss of $(1.5 million), or $(0.11) per share, for the corresponding period last year.
“We are extremely pleased with the results of this quarter,” declared Arotech Chairman and CEO Robert S. Ehrlich. “On every measure of performance — revenues, margins, EBITDA and net income — we met the goals we had set for ourselves, and improved both year-over-year and quarter-over-quarter,” continued Ehrlich. “We anticipate that we will continue to perform well in the fourth quarter, and that we will bring a strong backlog into 2013,” concluded Ehrlich.
First Nine Months Results
Revenues from continuing operations for the first nine months of 2012 reached $57.9 million, compared to $44.2 million for the corresponding period last year, an increase of 31.1% over the same period last year.
Gross profit from continuing operations for the first nine months of 2012 was $12.6 million, or 21.8% of revenues, compared to $11.1 million, or 25.2% of revenues, for the corresponding period last year, a 3.4 point decrease in the gross margin percentage.
Earnings (Loss) Before Interest, Taxes, Depreciation and Amortization (EBITDA) from continuing operations for the first nine months of 2012 was $1.8 million, compared to a loss of $(256,000) for the corresponding period last year. Arotech believes that information concerning EBITDA enhances overall understanding of its current financial performance. Arotech computes EBITDA, which is a non-GAAP financial measure, as reflected in the table below.
The Company’s net loss from continuing operations for the first nine months of 2012 was $(2.0 million), or $(0.12) per share, versus a net loss of $(3.4 million), or $(0.25) per share, for the corresponding period last year.
The Company’s net loss from all operations, including discontinued operations, for the first nine months of 2012 was $(3.5 million), or $(0.22) per share, versus a net loss of $(6.2 million), or $(0.45) per share, for the corresponding period last year.
Backlog
Backlog of orders totaled approximately $90.0 million as of September 30, 2012, as compared to $89.1 million at September 30, 2011 and $87.3 million as of June 30, 2012.
Cash Position at Quarter End
As of September 30, 2012, the Company had $758,000 in cash and $94,000 in restricted collateral deposits, as compared to December 31, 2011, when the Company had $2.3 million in cash and $1.7 million in restricted collateral deposits.
The Company also had $289,000 in unused bank lines of credit with its main bank as of September 30, 2012, under a $10.0 million credit facility under its FAAC subsidiary, which is secured by the Company’s assets and the assets of the Company’s other domestic subsidiaries and guaranteed by the Company and its other domestic subsidiaries, at a rate of LIBOR plus 375 basis points. This credit facility expires May 2013. There was $289,000 of available credit on this line as of September 30, 2012, based on the borrowing base calculations.
The Company had trade receivables of $10.0 million as of September 30, 2012, compared to $11.9 million as of December 31, 2011. The Company had a current ratio (current assets/current liabilities) of 1.33 as of September 30, 2012 and 1.36 as of December 31, 2011.
Conference Call
The Company will host a conference call Tuesday, November 13, 2012 at 9:00 a.m. EST. Those wishing to access the conference call should dial 1-877-407-0778 (U.S.) or 1-201-689-8565 (international) a few minutes before the 9:00 a.m. EST start time. A replay of the conference call will be available starting Tuesday, November 13, 2012 at 10:30 a.m. EST until Tuesday, November 20, 2012 at 11:59 p.m. The replay telephone number is 1-877-660-6853 (U.S.) and 1-201-612-7415 (international). The replay ID pass code for both the call and the replay is 403549.
About Arotech Corporation
Arotech Corporation is a leading provider of quality defense and security products for the military, law enforcement and homeland security markets, including multimedia interactive simulators/trainers and advanced zinc-air and lithium batteries and chargers. Arotech operates through two major business divisions: Training and Simulation, and Battery and Power Systems.
Arotech is incorporated in Delaware, with corporate offices in Ann Arbor, Michigan and research, development and production subsidiaries in Alabama, Michigan and Israel.
Except for the historical information herein, the matters discussed in this news release include forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, readers are cautioned not to place undue reliance on these forward-looking statements, as they are subject to various risks and uncertainties that may cause actual results to vary materially. These risks and uncertainties include, but are not limited to, risks relating to: product and technology development; the uncertainty of the market for Arotech’s products; changing economic conditions; delay, cancellation or non-renewal, in whole or in part, of contracts or of purchase orders; Arotech’s ability to remain listed on the Nasdaq Stock Market in accordance with the Nasdaq’s $1.00 minimum bid price and other continued listing standards; and other risk factors detailed in Arotech’s most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2011 and other filings with the Securities and Exchange Commission. Arotech assumes no obligation to update the information in this release. Reference to the Company’s website above does not constitute incorporation of any of the information thereon into this press release.
TABLES TO FOLLOW
AROTECH CORPORATION CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) (U.S. Dollars, except share data) Nine months ended Three months ended September 30, September 30, ------------------------ ------------------------ 2012 2011 2012 2011 ----------- ----------- ----------- ----------- Revenues $57,915,901 $44,170,119 $21,435,063 $21,137,932 ----------- ----------- ----------- ----------- Cost of revenues, exclusive of amortization of intangibles 45,307,654 33,043,351 16,475,160 17,019,125 Research and development expenses 1,657,056 1,290,656 610,095 435,707 Selling and marketing expenses 3,868,531 3,654,211 1,255,337 1,251,978 General and administrative expenses 7,066,080 7,744,637 2,064,695 2,780,788 Amortization of intangible assets and capitalized software 893,743 1,432,507 292,438 477,884 ----------- ----------- ----------- ----------- Total operating costs and expenses 58,793,064 47,165,362 20,697,725 21,965,482 ----------- ----------- ----------- ----------- Operating income (loss) (877,163) (2,995,243) 737,338 (827,550) ----------- ----------- ----------- ----------- Other income 9,894 36,086 9,141 3,587 Financial expenses, net (565,301) (162,873) (186,301) (152,768) ----------- ----------- ----------- ----------- Total other income (expense) (555,407) (126,787) (177,160) (149,181) ----------- ----------- ----------- ----------- Income (loss) from continuing operations before income tax expense (1,432,570) (3,122,030) 560,178 (976,731) ----------- ----------- ----------- ----------- Income tax expense 524,091 281,335 126,937 89 ----------- ----------- ----------- ----------- Income (loss) from continuing operations (1,956,661) (3,403,365) 433,241 (976,820) Income (loss) from discontinued operations, net of income tax (1,506,353) (2,837,061) 64,848 (549,022) ----------- ----------- ----------- ----------- Net income (loss) (3,463,014) (6,240,426) 498,089 (1,525,842) ----------- ----------- ----------- ----------- Other comprehensive income, net of income tax Foreign currency translation adjustment (189,414) (474,631) (17,903) (796,578) ----------- ----------- ----------- ----------- Comprehensive income (loss) $(3,652,428) $(6,715,057) $ 480,186 $(2,322,420) =========== =========== =========== =========== Basic net income/loss per share - continuing operations $ (0.13) $ (0.25) $ 0.03 $ (0.07) Basic net income/loss per share - discontinued operations $ (0.10) $ (0.20) $ 0.00 $ (0.04) ----------- ----------- ----------- ----------- Basic net income/loss per share $ (0.23) $ (0.45) $ 0.03 $ (0.11) =========== =========== =========== =========== Diluted net income/loss per share - continuing operations $ (0.12) $ (0.25) $ 0.03 $ (0.07) Diluted net income/loss per share - discontinued operations $ (0.10) $ (0.20) $ 0.00 $ (0.04) ----------- ----------- ----------- ----------- Diluted net income/loss per share $ (0.22) $ (0.45) $ 0.03 $ (0.11) =========== =========== =========== =========== Weighted average number of shares used in computing basic net income/loss per share 15,308,724 13,922,270 15,336,947 14,216,701 =========== =========== =========== =========== Weighted average number of shares used in computing diluted net income/loss per share 15,911,464 13,922,270 15,939,687 14,216,701 =========== =========== =========== ===========
Reconciliation of Non-GAAP Financial Measure – Continuing Operations
To supplement Arotech’s consolidated financial statements presented in accordance with U.S. GAAP, Arotech uses a non-GAAP measure, Earnings (Loss) Before Interest, Taxes, Depreciation and Amortization (EBITDA). This non-GAAP measure is provided to enhance overall understanding of Arotech’s current financial performance and its progress towards GAAP profitability. Reconciliation of EBITDA to the nearest GAAP measure follows:
Nine months ended Three months ended September 30, September 30, ------------------------ ----------------------- 2012 2011 2012 2011 ----------- ----------- ----------- ----------- Net Income (loss) continuing (GAAP measure) $(1,956,661) $(3,403,365) $ 433,241 $ (976,820) Add back: Financial (income) expense - including interest 565,301 162,873 186,301 152,768 Income tax expenses (benefit) 524,091 281,335 126,937 89 Depreciation and amortization expense 1,726,573 2,250,146 571,865 759,155 Other adjustments* 912,978 452,902 61,555 352,484 ----------- ----------- ----------- ----------- Total adjusted EBITDA $ 1,772,282 $ (256,109) $ 1,379,899 $ 287,676 =========== =========== =========== =========== * Includes stock compensation expense, adjustments to allowances, one-time transaction expenses and other non-cash expenses.
CONTACT:
Victor Allgeier
TTC Group
(646) 290-6400
FAB Universal (FU) Announces over 100% Increase in Advertising Revenue For Libsyn
AB Universal (NYSE MKT: FU), a worldwide distributor of digital entertainment, today announced 2012 third quarter revenue growth of 186% over the third quarter of 2011 for its podcasting platform, Libsyn.
The Libsyn podcasting platform offers a suite of powerful monetization tools for publishers including a dynamic advertising and campaign management system (Alchemy) that targets the 25 million unique monthly audience members who download entertainment from the network. Advertising revenue grew 116% in the third quarter versus the second quarter of 2012. Advertising revenue is generated through the placement of third party podcast advertisements and producer-provided ads. The Alchemy system dynamically stitches ads into the content and provides campaign management and reporting. Revenues are generated through paid placement of podcast advertising from which the producers receive revenue sharing.
“It is very exciting to see a resurgence in podcast advertising, resulting from continued growth in podcast popularity. Advertising was one of the early monetization options for producers and Libsyn has developed many tools specifically geared to help producers maximize their monetization opportunities via advertising,” said Chris Spencer, CEO, FAB Universal Corp. “We know that podcast advertising is successful and have worked with many different Advertising Agencies including Performance Bridge, with whom we have run various monthly ad campaigns each and every month over the last five years. We now look forward to using our knowledge base and technology lead to expand our marketing channels in the US as well in our international franchises across China.”
Libsyn is very excited to announce a new advertiser, Ting.com, that is now working with podcasts on the Libsyn network. Ting is a mobile phone service provider covering the U.S. market. “We find that the relationship between podcast hosts and their audience creates an ROI for our advertising spend that is second to none,” said Sean Hurley, Marketing Manager of Ting. “There is a level of engagement between a podcaster and his audience that banner advertisements just can’t come anywhere close to replicating.”
About FAB Universal Corp:
FAB Universal Corp. is a global leader in digital media entertainment sales and distribution. FAB delivers media to its customers worldwide through Intelligent Kiosks, Retail Stores, Retail Franchises and online through Apple iTunes and Google Android through three business units: Digital Media Services, Retail Media Sales and Wholesale Media Distribution. We distribute billions of movie, music, podcast, TV show and other digital files to consumers in 240 countries. Sales of digital media are generated through kiosks networks, subscription sales for mobile devices, smartphone Apps and Netflix-like subscription models. In 2011, we distributed billions of downloads of copyrighted music, video games, ringtones, ebooks, movies and podcasts to over 50 million people worldwide through iPods, iPhones, iPads, iTunes, Blackberrys, Windows Phones, Androids and many other devices and destinations. We are a publicly held, Pittsburgh based company with thousands of shareholders and a world-class team. Visit us on the web at www.fabuniversal.com, email us at contact@fabuniversal.com.
Legal Notice
Legal Notice Regarding Forward-Looking Statements: “Forward-looking Statements” as defined in the Private Securities litigation Reform Act of 1995 may be included in this news release. These statements relate to future events or our future financial performance. These statements are only predictions and may differ materially from actual future results or events. We disclaim any intention or obligation to revise any forward-looking statements whether as a result of new information, future developments or otherwise. There are important risk factors that could cause actual results to differ from those contained in forward-looking statements, including, but not limited to risks associated with changes in general economic and business conditions, actions of our competitors, the extent to which we are able to develop new services and markets for our services, the time and expense involved in such development activities, the level of demand and market acceptance of our services, changes in our business strategies and acts of terror against the United States.
IFMI (IFMI) Reports Third Quarter 2012 Financial Results
Adjusted Operating Income of $4.4 million or $0.27 per Diluted Share Net Income Attributable to IFMI of $2.0 million or $0.18 per Diluted Share Board Declares Dividend of $0.02 per Share
Institutional Financial Markets, Inc. (NYSE AMEX: IFMI), an investment firm specializing in credit-related fixed income investments, today reported financial results for its third quarter ended September 30, 2012.
Adjusted operating income was $4.4 million, or $0.27 per diluted share, for the three months ended September 30, 2012, compared to adjusted operating loss of $4.0 million, or $0.25 per diluted share, for the three months ended September 30, 2011, and adjusted operating income of $2.8 million, or $0.17 per diluted share, for the three months ended June 30, 2012. Adjusted operating income was $3.1 million, or $0.20 per diluted share, for the nine months ended September 30, 2012, compared to adjusted operating income of $3.2 million, or $0.20 per diluted share, for the nine months ended September 30, 2011. Adjusted operating income (loss) is not a measure recognized under generally accepted accounting principles (“GAAP”). See Note 1 on page 4.
“We are generally pleased with IFMI’s performance during the third quarter, which reflected continued improvement in our operating results, despite volume pressures that persisted in our trading business,” said Daniel G. Cohen, Chairman and Chief Executive Officer of IFMI. “Quarterly year-over-year net trading revenue was basically flat even though we substantially reduced headcount and compensation in our capital markets business. Also, we generally anticipate some drop off in our trading business during the third quarter summer months. The biggest decline from the prior quarter was in Europe, which seems to be rebounding nicely in early fourth quarter results. Also this quarter, we closed several investment banking transactions in our capital markets business, benefited from realized gains in our principal investing business, and experienced positive developments in our asset management business. While there is still some work to be done, we are encouraged by the significant progress made across our diverse operating units and our focus remains on increasing value for our shareholders.”
Comparisons to Prior Year Periods
Revenue was $28.1 million for the three months ended September 30, 2012, compared to $20.9 million for the three months ended September 30, 2011. The $7.2 million increase was primarily the result of increases in asset management revenue of $3.2 million, in new issue and advisory revenue of $1.1 million, and in principal transactions and other revenue of $3.3 million, partially offset by a decrease in net trading revenue of $0.3 million. The increase in asset management revenue was primarily the result of a one-time final portfolio management fee of $3.8 million related to the termination of one of IFMI’s European collateralized debt obligations in the third quarter of 2012, partially offset by reductions in revenue due to the continued deterioration in assets under management in the Company’s managed collateralized debt obligations. The increase in new issue and advisory revenue was due to a large advisory assignment completed in the third quarter of 2012 while there were several smaller advisory assignments completed in the third quarter of 2011. The increase in principal transactions and other revenue was primarily the result of a realized gain of $1.7 million on one of the Company’s investments that was sold in the third quarter of 2012; $1.7 million in unrealized mark-to-market gains on the Company’s permanent capital vehicle investments in the third quarter of 2012 versus $0.7 million in unrealized mark-to-market gains in the third quarter of 2011; and $0.4 million of dividends in the third quarter of 2012 versus $0.2 million of dividends in the third quarter of 2011. The offsetting decline in year-over-year net trading revenue occurred in the Company’s PrinceRidge operations, while net trading revenue at JVB and in Europe increased slightly.
Revenue was $71.9 million for the nine months ended September 30, 2012, compared to $76.6 million for the nine months ended September 30, 2011. The $4.8 million decrease was the result of decreases of $6.2 million in net trading revenue and $1.1 million in principal transactions and other revenue, partially offset by increases in new issue and advisory revenue of $1.1 million and asset management revenue of $1.5 million. The decrease in principal transactions and other revenue was primarily the result of $2.7 million more in mark-to-market losses on the investment in Star Asia during the current year nine month period, partially offset by the previously mentioned realized gains of $1.7 million on one of the Company’s investments that was sold in the third quarter of 2012. The increase in asset management revenue was primarily the result of the one-time final portfolio management fee of $3.8 million, partially offset by reductions in revenue due to the continued deterioration in assets under management in the Company’s managed collateralized debt obligations.
Compensation and benefits expense was $16.5 million for the three months ended September 30, 2012, compared to $19.4 million for the three months ended September 30, 2011, a decrease of $2.9 million, or 15%. Compensation as a percentage of revenue was 59% in the third quarter of 2012, as compared to 93% in the third quarter of 2011. The number of IFMI employees decreased from 240 at September 30, 2011 to 204 at September 30, 2012.
Net income attributable to IFMI was $2.0 million, or $0.18 per diluted share, for the three months ended September 30, 2012, compared to net loss attributable to IFMI of $4.0 million, or $0.38 per diluted share, for the three months ended September 30, 2011. Net loss attributable to IFMI was $3.9 million, or $0.37 per diluted share, for the nine months ended September 30, 2012, compared to a net loss attributable to IFMI of $7.0 million, or $0.65 per diluted share, for the nine months ended September 30, 2011.
Comparisons to Prior Quarter
Revenue was $28.1 million for the three months ended September 30, 2012, compared to $25.0 million for the three months ended June 30, 2012. This increase was the result of increases of $3.9 million in asset management revenue, $1.6 million in new issue and advisory revenue, and $3.9 million in principal transactions and other revenue, which were partially offset by a decrease of $6.3 million in net trading revenue. The increase in asset management revenue was primarily a result of the one-time final portfolio management fee of $3.8 million in the third quarter of 2012. The increase in new issue and advisory revenue was due to the large advisory assignment completed in the third quarter of 2012 while there were several smaller advisory assignments completed in the second quarter of 2012. The increase in principal transactions and other revenue was primarily the result of the realized gain of $1.7 million on one of the Company’s investments that was sold in the third quarter of 2012; $1.3 million in unrealized mark-to-market gains on the Company’s Star Asia investment in the third quarter of 2012 versus $0.1 million in unrealized mark-to-market gains in the second quarter of 2012; $0.3 million in unrealized mark-to-market gains on the Company’s other permanent capital vehicle investments in the third quarter of 2012 versus $0.2 million in unrealized mark-to-market losses in the second quarter of 2012; and $0.4 million of dividends in the third quarter of 2012 versus $0.1 million in the second quarter of 2012. The offsetting decline in net trading revenue occurred across all of the Company’s broker-dealer businesses and was primarily driven by less trading activity during the slower summer months, and was most predominant in Europe, which had a strong second quarter in 2012.
Net income attributable to IFMI was $2.0 million, or $0.18 per diluted share, for the three months ended September 30, 2012, compared to net loss attributable to IFMI of $2.1 million, or $0.19 per diluted share, for the three months ended June 30, 2012.
Total Permanent Equity and Dividend Declaration
- At September 30, 2012, total permanent equity was $71.5 million, as compared to $77.4 million as of December 31, 2011.
- The Company’s Board of Directors has declared a dividend of $0.02 per share. The dividend will be payable on December 3, 2012 to stockholders of record on November 19, 2012.
Other Events
Opening of Asset Management Office in Madrid, Spain. At the end of August, the Company became the lead manager of a collateralized loan obligation (“CLO”) containing a portfolio of broadly syndicated European loans. Prior to August 2012, the Company served only as the junior manager of this CLO and shared the management fees evenly with the lead manager. In August, the Company became the lead manager (and remained as junior manager) and now earns all of the management fees related to this CLO. As the junior manager, the Company recognized $1.7 million of revenue during the twelve months ended September 30, 2012. In connection therewith, the Company hired a CLO asset management team of ten professionals and opened an office in Madrid, Spain.
Completion of PrinceRidge Leadership Change. During the third quarter, the Company completed the previously announced separation with the former Chairman and the former CEO of PrinceRidge, as well as the related buyout of their ownership interests in PrinceRidge. In connection with the related separation agreements, PrinceRidge agreed to repurchase all PrinceRidge securities owned by the former Chairman and the former CEO of PrinceRidge. PrinceRidge paid the former Chairman and the former CEO of PrinceRidge, in the aggregate, approximately $8.2 million in cash, of which $6.1 million represented the aggregate value of their capital accounts in PrinceRidge and $2.1 million was a one-time compensation expense. In addition, the former Chairman and the former CEO of PrinceRidge agreed to forfeit all unvested equity awards that they had received from PrinceRidge and the Company, including, in the aggregate, 848,742 shares of restricted common stock of IFMI.
Buyout of PrinceRidge Minority Partners. On October 5, 2012, the Company entered into Separation, Release and Repurchase Agreements with three PrinceRidge minority partners (the “Separated Employees”). Under these agreements, each of the Separated Employees resigned from all positions and offices held with PrinceRidge and its affiliates. In addition, PrinceRidge agreed to accelerate its obligation to repurchase all PrinceRidge securities owned by the Separated Employees. In connection with the repurchase of these securities, PrinceRidge paid the Separated Employees, in the aggregate, approximately $2.6 million in cash, and PrinceRidge issued to the Separated Employees promissory notes in the initial aggregate principal amount of approximately $4.8 million. The aggregate consideration received by the Separated Employees represented a discount of approximately 6% from the aggregate value of the Separated Employees’ capital accounts in PrinceRidge as of September 30, 2012. The terms and conditions of each of the promissory notes are substantially the same. Under each of the promissory notes, interest accrues on the unpaid balance of the principal amount at a rate of 5% per annum until the aggregate principal amount is paid in full. Each of the promissory notes matures on December 21, 2012, and there is no penalty for pre-payment. Following the repurchase of these securities, IFMI owns 98% of the equity interests in PrinceRidge.
Conference Call
Management will hold a conference call this morning at 10:00 AM EST to discuss these results. The conference call will also be available via webcast. Interested parties can access the live webcast by clicking the webcast link on the Company’s homepage at www.IFMI.com. Those wishing to listen to the conference call with operator assistance can dial (877) 686-9573 (domestic) or (706) 643-6983 (international), participant pass code 67399304, or request the IFMI earnings call. A recording of the call will be available for two weeks following the call by dialing (800) 585-8367 (domestic) or (404) 537-3406 (international), participant pass code 67399304.
About IFMI
IFMI is a financial services company specializing in credit-related fixed income investments. IFMI was founded in 1999 as an investment firm focused on small-cap banking institutions, but has grown to provide an expanding range of asset management, capital markets, and investment banking solutions to institutional investors and corporations. IFMI’s primary operating segments are Capital Markets and Asset Management. The Capital Markets segment consists of credit-related fixed income sales, trading, and financing as well as new issue placements in corporate and securitized products and advisory services, operating primarily through IFMI’s subsidiaries, PrinceRidge Holdings LP and JVB Financial Holdings, LLC in the United States, and Cohen & Company Financial Limited in Europe. The Asset Management segment manages assets through collateralized debt obligations, permanent capital vehicles, and managed accounts. As of September 30, 2012, IFMI managed approximately $6.3 billion in credit-related fixed income assets in a variety of asset classes including U.S. trust preferred securities, European hybrid capital securities, Asian commercial real estate debt, and mortgage- and asset-backed securities. For more information, please visit www.IFMI.com.
Note 1: Adjusted operating income (loss) and adjusted operating income (loss) per share are non-GAAP measures of performance. Please see the discussion of non-GAAP measures of performance below. Also see the tables below for the reconciliations of non-GAAP measures of performance to their corresponding GAAP measures of performance.
Forward-looking Statements
This communication contains certain statements, estimates and forecasts with respect to future performance and events. These statements, estimates and forecasts are “forward-looking statements.” In some cases, forward-looking statements can be identified by the use of forward-looking terminology such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “seek” or “continue” or the negatives thereof or variations thereon or similar terminology. All statements other than statements of historical fact included in this communication are forward-looking statements and are based on various underlying assumptions and expectations and are subject to known and unknown risks, uncertainties and assumptions, and may include projections of our future financial performance based on our growth strategies and anticipated trends in our business. These statements are based on our current expectations and projections about future events. There are important factors that could cause our actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied in the forward-looking statements including, but not limited to, those discussed under the heading “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition” in our filings with the Securities and Exchange Commission (“SEC”), which are available at the SEC’s website at www.sec.gov and our website at www.IFMI.com/sec-filings. Such risk factors include the following: (a) a decline in general economic conditions or the global financial markets, (b) losses caused by financial or other problems experienced by third parties, (c) losses due to unidentified or unanticipated risks, (d) a lack of liquidity, i.e., ready access to funds for use in our businesses, (e) the ability to attract and retain personnel, (f) litigation and regulatory issues, (g) competitive pressure, (h) a potential ownership change under Section 382 of the Internal Revenue Code, (i) an inability to generate incremental income from acquired businesses, and (j) unanticipated market closures due to inclement weather. As a result, there can be no assurance that the forward-looking statements included in this communication will prove to be accurate or correct. In light of these risks, uncertainties and assumptions, the future performance or events described in the forward-looking statements in this communication might not occur. Accordingly, you should not rely upon forward-looking statements as a prediction of actual results and we do not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Cautionary Note Regarding Quarterly Financial Results
General
Due to the nature of our business, our revenue and operating results may fluctuate materially from quarter to quarter. Accordingly, revenue and net income in any particular quarter may not be indicative of future results. Further, our employee compensation arrangements are in large part incentive-based and therefore will fluctuate with revenue. The amount of compensation expense recognized in any one quarter may not be indicative of such expense in future periods. As a result, we suggest that annual results may be the most meaningful gauge for investors in evaluating our business performance.
INSTITUTIONAL FINANCIAL MARKETS, INC. | |||||||||||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) | |||||||||||||||||||||
(in thousands, except per share data) | |||||||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||||||
9/30/12 | 6/30/12 | 9/30/11 | 9/30/12 | 9/30/11 | |||||||||||||||||
Revenues | |||||||||||||||||||||
Net trading | $ | 13,669 | $ | 19,951 | $ | 14,008 | $ | 51,311 | $ | 57,522 | |||||||||||
Asset management | 8,465 | 4,608 | 5,296 | 18,010 | 16,521 | ||||||||||||||||
New issue and advisory | 1,758 | 189 | 705 | 3,024 | 1,945 | ||||||||||||||||
Principal transactions and other income | 4,174 | 289 | 869 | (482) | 661 | ||||||||||||||||
Total revenues | 28,066 | 25,037 | 20,878 | 71,863 | 76,649 | ||||||||||||||||
Operating expenses | |||||||||||||||||||||
Compensation and benefits | 16,484 | 17,053 | 19,399 | 49,811 | 62,820 | ||||||||||||||||
Business development, occupancy, equipment | 1,520 | 1,276 | 1,942 | 3,970 | 5,216 | ||||||||||||||||
Subscriptions, clearing, and execution | 2,602 | 2,899 | 3,500 | 8,574 | 9,042 | ||||||||||||||||
Professional services and other operating | 4,015 | 2,636 | 3,237 | 9,702 | 12,389 | ||||||||||||||||
Depreciation and amortization | 289 | 343 | 612 | 1,023 | 1,585 | ||||||||||||||||
Total operating expenses | 24,910 | 24,207 | 28,690 | 73,080 | 91,052 | ||||||||||||||||
Operating income (loss) | 3,156 | 830 | (7,812) | (1,217) | (14,403) | ||||||||||||||||
Non-operating income (expense) | |||||||||||||||||||||
Interest expense, net | (868) | (1,104) | (1,282) | (3,187) | (4,211) | ||||||||||||||||
Other non-operating income (expense) | – | (4,357) | – | (4,357) | – | ||||||||||||||||
Gain (loss) on repurchase of debt | 83 | – | – | 86 | – | ||||||||||||||||
Income (loss) on from equity method affiliates | 647 | 1,526 | 838 | 2,689 | 5,368 | ||||||||||||||||
Income (loss) before income taxes | 3,018 | (3,105) | (8,256) | (5,986) | (13,246) | ||||||||||||||||
Income tax expense (benefit) | 54 | 63 | (571) | 108 | (917) | ||||||||||||||||
Net income (loss) | 2,964 | (3,168) | (7,685) | (6,094) | (12,329) | ||||||||||||||||
Less: Net income (loss) attributable to the noncontrolling
interest |
956 | (1,090) | (3,640) | (2,165) | (5,288) | ||||||||||||||||
Net income (loss) attributable to IFMI | $ | 2,008 | $ | (2,078) | $ | (4,045) | $ | (3,929) | $ | (7,041) | |||||||||||
INSTITUTIONAL FINANCIAL MARKETS, INC. | |||||||||||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) | |||||||||||||||||||||
(in thousands, except per share data) | |||||||||||||||||||||
Earnings per share | |||||||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||||||
9/30/12 | 6/30/12 | 9/30/11 | 9/30/12 | 9/30/11 | |||||||||||||||||
Basic | |||||||||||||||||||||
Net income (loss) attributable to IFMI | $ | 2,008 | $ | (2,078) | $ | (4,045) | $ | (3,929) | $ | (7,041) | |||||||||||
Basic shares outstanding | 10,849 | 10,756 | 10,595 | 10,683 | 10,772 | ||||||||||||||||
Net income (loss) attributable to IFMI per share | $ | 0.19 | $ | (0.19) | $ | (0.38) | $ | (0.37) | $ | (0.65) | |||||||||||
Fully Diluted | |||||||||||||||||||||
Net income (loss) attributable to IFMI | $ | 2,008 | $ | (2,078) | $ | (4,045) | $ | (3,929) | $ | (7,041) | |||||||||||
Net income (loss) attributable to the noncontrolling interest | 956 | (1,090) | (3,640) | (2,165) | (5,288) | ||||||||||||||||
Net loss attributable to the noncontrolling interest that is not
converted |
11 | 109 | 1,335 | 249 | 1,388 | ||||||||||||||||
Adjustment | (5) | (23) | 247 | (93) | 440 | ||||||||||||||||
Enterprise net income (loss) | $ | 2,970 | $ | (3,082) | $ | (6,103) | $ | (5,938) | $ | (10,501) | |||||||||||
Basic shares outstanding | 10,849 | 10,756 | 10,595 | 10,683 | 10,772 | ||||||||||||||||
Unrestricted Operating LLC membership units exchangeable
into IFMI shares |
5,252 | 5,252 | 5,258 | 5,252 | 5,275 | ||||||||||||||||
Additional dilutive shares | 76 | – | – | – | – | ||||||||||||||||
Fully diluted shares outstanding | 16,177 | 16,008 | 15,853 | 15,935 | 16,047 | ||||||||||||||||
Fully diluted net income (loss) per share | $ | 0.18 | $ | (0.19) | $ | (0.38) | $ | (0.37) | $ | (0.65) | |||||||||||
Reconciliation of adjusted operating income (loss) to operating income (loss) and calculations of per share amounts | |||||||||||||||||||||
Operating income (loss) | $ | 3,156 | $ | 830 | $ | (7,812) | $ | (1,217) | $ | (14,403) | |||||||||||
Noncontrolling interest portion of PrinceRidge operating loss | 401 | 196 | 1,642 | 791 | 1,708 | ||||||||||||||||
Depreciation and amortization | 289 | 343 | 612 | 1,023 | 1,585 | ||||||||||||||||
One-time cash compensation related to former CEO of
capital markets segment |
– | – | – | – | 3,000 | ||||||||||||||||
One-time cash compensation related to former Chairman
and former CEO of PrinceRidge |
2,104 | – | – | 2,104 | – | ||||||||||||||||
IFMI share of incentive fees included in income from equity
method investments |
– | – | – | – | 4,359 | ||||||||||||||||
Share-based compensation | (1,534) | 1,420 | 1,543 | 434 | 6,969 | ||||||||||||||||
Adjusted operating income (loss) | $ | 4,416 | $ | 2,789 | $ | (4,015) | $ | 3,135 | $ | 3,218 | |||||||||||
Fully diluted shares outstanding | 16,177 | 16,008 | 15,853 | 15,935 | 16,047 | ||||||||||||||||
Adjusted operating income (loss) per share | $ | 0.27 | $ | 0.17 | $ | (0.25) | $ | 0.20 | $ | 0.20 | |||||||||||
INSTITUTIONAL FINANCIAL MARKETS, INC. | |||||||||
CONSOLIDATED BALANCE SHEETS | |||||||||
(in thousands) | |||||||||
September 30, 2012 | |||||||||
(unaudited) | December 31, 2011 | ||||||||
Assets | |||||||||
Cash and cash equivalents | $ | 12,876 | $ | 18,221 | |||||
Receivables from brokers, dealers, and clearing agencies | 3,149 | 70,963 | |||||||
Due from related parties | 712 | 679 | |||||||
Other receivables | 7,023 | 5,531 | |||||||
Investments – trading | 204,854 | 124,546 | |||||||
Other investments, at fair value | 39,472 | 42,772 | |||||||
Receivables under resale agreements | 153,039 | 129,978 | |||||||
Goodwill | 11,113 | 11,206 | |||||||
Other assets | 15,364 | 16,694 | |||||||
Total assets | $ | 447,602 | $ | 420,590 | |||||
Liabilities | |||||||||
Payables to brokers, dealer, and clearing agencies | $ | 102,549 | $ | 24,633 | |||||
Accounts payable and other liabilities | 11,755 | 13,567 | |||||||
Accrued compensation | 10,081 | 8,657 | |||||||
Trading securities sold, not yet purchased | 55,800 | 99,613 | |||||||
Securities sold under agreements to repurchase | 153,173 | 134,870 | |||||||
Deferred income taxes | 7,914 | 7,500 | |||||||
Debt | 25,646 | 37,167 | |||||||
Mandatorily redeemable equity interests | 8,368 | 3,149 | |||||||
Total liabilities | 375,286 | 329,156 | |||||||
Temporary Equity | |||||||||
Redeemable noncontrolling interest | 770 | 14,026 | |||||||
Permanent Equity | |||||||||
Series B voting nonconvertible preferred stock | 5 | 5 | |||||||
Common stock | 11 | 10 | |||||||
Additional paid-in capital | 64,290 | 63,032 | |||||||
Accumulated other comprehensive loss | (503) | (626) | |||||||
Accumulated deficit | (10,024) | (5,121) | |||||||
Treasury stock, at cost; 0 and 50,400 shares of common stock, respectively | – | (328) | |||||||
Total IFMI stockholders’ equity | 53,779 | 56,972 | |||||||
Noncontrolling interest | 17,767 | 20,436 | |||||||
Total permanent equity | 71,546 | 77,408 | |||||||
Total liabilities and equity | $ | 447,602 | $ | 420,590 | |||||
Non-GAAP Measures
Adjusted operating income (loss) and adjusted operating income (loss) per diluted share
Adjusted operating income (loss) is not a financial measure recognized by GAAP. Adjusted operating income (loss) represents operating income, computed in accordance with GAAP, before depreciation and amortization, one-time compensation charges related to the former CEO of the capital markets segment and the former Chairman and former CEO of PrinceRidge, share-based compensation expense, and the non-convertible non-controlling interest’s share of operating income (loss), plus the Company’s share of any incentive fees earned included in income from equity method affiliates. The one-time compensation charges related to the former CEO of the capital markets segment and the former Chairman and former CEO of PrinceRidge were excluded due to the non-recurring nature of the expenses. Depreciation, amortization and share based compensation expenses that have been excluded from adjusted operating income (loss) are non-cash items. Incentive fees earned as a component of income from equity method affiliates is included so that all incentive fees earned are treated in a consistent manner as part of adjusted operating income (loss). Adjusted operating income (loss) per diluted share is calculated, by dividing adjusted operating income (loss) by diluted shares outstanding calculated in accordance with GAAP.
We present adjusted operating income (loss) and related per diluted share amounts in this release because we consider them to be useful and appropriate supplemental measures of our performance. Adjusted operating income (loss) and related per diluted share amounts help us to evaluate our performance without the effects of certain GAAP calculations that may not have a direct cash or recurring impact on our current operating performance. In addition, our management uses adjusted operating income (loss) and related per diluted share amounts to evaluate the performance of our operations. Adjusted operating income (loss) and related per diluted share amounts, as we define them, are not necessarily comparable to similarly entitled measures of other companies and may not be appropriate measures for performance relative to other companies. Adjusted operating income (loss) should not be assessed in isolation from or construed as a substitute for operating income prepared in accordance with GAAP. Adjusted operating income (loss) is not intended to represent, and should not be considered to be a more meaningful measure than, or an alternative to, measures of operating performance as determined in accordance with GAAP.
VistaGen (VSTA) and Duke University Announce Heart Tissue Engineering Progress
VistaGen Therapeutics and Duke University Announce Heart Tissue Engineering Progress at American Heart Association 2012 Scientific Sessions
SOUTH SAN FRANCISCO, CA — (Marketwire) — 11/07/12 — VistaGen Therapeutics, Inc. (OTCBB: VSTA) (OTCQB: VSTA), a biotechnology company applying stem cell technology for drug rescue, predictive toxicology and drug metabolism screening, and Duke University, one of the country’s premier academic research institutions, announced that results of their collaboration were presented yesterday at the American Heart Association 2012 Scientific Sessions in Los Angeles.
The presentation, entitled “Human embryonic stem cell-derived cardiac tissue patch with advanced structure and function,” highlighted the important synergistic interactions of VistaGen’s stem cell-derived human cardiomyocytes (heart cells) and Duke’s tissue engineering and analytical technologies. The research, which expands the scope of VistaGen’s drug rescue capabilities focused on heart toxicology, was led at Duke by Dr. Nenad Bursac, Associate Professor in the Departments of Biomedical Engineering and Cardiology, and at VistaGen by Dr. Ralph Snodgrass, President and Chief Scientific Officer.
The high-quality and purity of VistaGen’s cardiomyocytes, together with Dr. Bursac’s innovative tissue engineering technologies, enabled the development of novel methods of engineering three-dimensional (3D) cardiac tissues and unique in vitro systems for studying the maturation and electromechanical function of human cardiac muscle. These technologies provide novel in vitro tools for evaluating drug effects, positive and negative, on human cardiac tissues.
“I am very excited by the opportunities created and results we have achieved by combining our stem cell-based cardiomyocyte technologies and expertise with Dr. Bursac’s leading-edge tissue engineering team at Duke,” stated Dr. Snodgrass. “This important collaboration further demonstrates the quality and functionality of our pluripotent stem cell-derived cardiomyocytes, and suggests potential new tools for our cardiac drug rescue program, while also highlighting the potential therapeutic applications for our combined technologies.”
“VistaGen’s human cardiomyocytes produced engineered cardiac tissues that exhibited functional properties far superior to those previously reported,” said Dr. Bursac. “These superior properties offer exciting new opportunities to develop novel electrical and mechanical tools to guide and evaluate our tissue engineering design of functional bioartificial muscle for stem cell-based therapies aimed at treating heart disease and injury, as well as cardiac arrhythmias.”
About Dr. Bursac
Dr. Bursac, Associate Professor in the Departments of Cardiology and Biomedical Engineering at Duke University, is a leader in the field of cardiac tissue engineering and cell-based therapies in which different cells, either alone or in combination with therapeutic molecules or biomaterials, can be transplanted into the human body to restore function of damaged or diseased organs. Dr. Bursac’s research has additional applications in the fields of cardiac electrophysiology and in vitro drug screening. Over the last five years, Dr. Bursac’s lab has developed and validated novel bioengineered model systems and experimental tools that are providing a more detailed understanding of normal and abnormal heart muscle development and function, the intricate processes of cardiomyogenesis and the potential of stem cell-based tissue engineering therapies for the treatment of different heart muscle diseases, cardiac infarction and arrhythmias.
About VistaGen Therapeutics
VistaGen is a biotechnology company applying human pluripotent stem cell technology for drug rescue, predictive toxicology and drug metabolism screening. VistaGen’s drug rescue activities combine its human pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube™, with modern medicinal chemistry to generate new chemical variants (Drug Rescue Variants) of once-promising small-molecule drug candidates. These are drug candidates discontinued by pharmaceutical companies, the U.S. National Institutes of Health (NIH) or university laboratories after substantial investment and development due to heart or liver toxicity or metabolism issues. VistaGen uses its pluripotent stem cell technology to generate early indications, or predictions, of how humans will ultimately respond to new drug candidates before they are ever tested in humans, bringing human biology to the front end of the drug development process.
Additionally, VistaGen’s small molecule drug candidate, AV-101, is completing Phase 1 development for treatment of neuropathic pain. Neuropathic pain, a serious and chronic condition causing pain after an injury or disease of the peripheral or central nervous system, affects millions of people worldwide. To date, VistaGen has been awarded over $8.5 million from the NIH for development of AV-101.
Visit VistaGen at http://www.VistaGen.com, follow VistaGen at http://www.twitter.com/VistaGen or view VistaGen’s Facebook page at http://www.facebook.com/VistaGen.
Cautionary Statement Regarding Forward Looking Statements
The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to the success of VistaGen’s research collaboration with Duke University, its stem cell technology-based predictive toxicology and metabolism screening and drug rescue activities, its AV-101 Phase 1 clinical program, its ability to enter into predictive toxicology, metabolism screening and/or drug rescue collaborations and/or licensing arrangements with respect to one or more drug rescue variants, risks and uncertainties relating to the availability of substantial additional capital to support its research, drug rescue, development and commercialization activities, and the success of its research and development plans and strategies, including those plans and strategies related to AV-101 and any drug rescue variant identified and developed by VistaGen. These and other risks and uncertainties are identified and described in more detail in VistaGen’s filings with the Securities and Exchange Commission (SEC). These filings are available on the SEC’s website at www.sec.gov. VistaGen undertakes no obligation to publicly update or revise any forward-looking statements.
For More Information:
Shawn K. Singh, J.D.
Chief Executive Officer
VistaGen Therapeutics, Inc.
www.VistaGen.com
650-244-9990 x224
Investor.Relations@VistaGen.com
Mission Investor Relations
Atlanta, Georgia
http://www.MissionIR.com
404-941-8975
AdCare Health Systems (ADK) Prices Offering of Series A Preferred Stock
ATLANTA, Nov. 6, 2012 /PRNewswire/ — AdCare Health Systems, Inc. (NYSE MKT: ADK) (the “Company”) announced today that it has priced a “best efforts” underwritten public offering of its 10.875% Series A Cumulative Redeemable Preferred Stock (the “Series A Preferred Stock”) at a public offering price of $23.00 per share. Gross proceeds to the Company are expected to be approximately $10,350,000. The closing of the offering is scheduled for November 14, 2012, subject to customary closing conditions. The Company intends to use the net proceeds from the offering for working capital and other general corporate purposes, which may include the repayment of certain indebtedness. The Company has filed an application to list the Series A Preferred Stock on the NYSE MKT under the symbol “ADK.PRA.” MLV & Co. LLC is acting as Sole Book-Running Manager for the offering. GVC Capital LLC, Ladenburg Thalmann & Co. Inc. and C.K. Cooper & Company are acting as Co-Managers.
The offering is being made pursuant to the Company’s existing effective shelf registration statement, previously filed with the Securities and Exchange Commission (“SEC”). A final prospectus relating to the offering will be filed with the SEC. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
The offering of these securities will be made only by means of a prospectus and related prospectus supplement, when available. Before you invest, you should read the prospectus in the registration statement and related prospectus supplements and other documents that the Company has filed with the SEC for more complete information about the Company and this offering. Copies of the prospectus and accompanying preliminary prospectus supplement relating to these securities can be obtained for free by visiting EDGAR on the SEC website at www.sec.gov or by written request to AdCare Health Systems, Inc., 1145 Hembree Road, Roswell, GA 30076. Alternatively, you may obtain these documents by contacting the underwriters at MLV & Co. LLC, 1251 Avenue of the Americas, New York, NY 10020, Attention: Randy Billhardt, Email: rbillhardt@mlvco.com; Telephone: (212) 542-5882.
About AdCare Health Systems, Inc.
AdCare Health Systems, Inc. is a recognized provider of senior living and health care facility management. AdCare owns and manages long-term care facilities and retirement communities, and since the company’s inception in 1988, its mission has been to provide the highest quality of healthcare services to the elderly through its operating subsidiaries, including a broad range of skilled nursing and sub-acute care services. For more information about AdCare, visit www.adcarehealth.com.
Important Cautions Regarding Forward-Looking Statements
This press release includes statements that may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with regard to the Company’s planned offering of the Series A Preferred Stock and the intended use of proceeds. Such forward-looking statements are subject to a variety of known and unknown risks, uncertainties, and other factors that are difficult to predict and many of which are beyond management’s control. Factors that can affect future results are discussed in the documents filed by the Company from time to time with the Securities and Exchange Commission. Except where required by law, the Company undertakes no obligation to update or revise any forward-looking statement to reflect events or circumstances after the date of this press release.
AMRI (AMRI) Announces Third Quarter 2012 Results
– Increases 2012 EPS Guidance, Including Higher 2012 Royalty Revenue Guidance; Tightens Range for 2012 Contract Revenue Guidance
ALBANY, New York, Nov. 6, 2012 /PRNewswire/ — AMRI (NASDAQ: AMRI) today reported financial and operating results for the third quarter and year-to-date period ended September 30, 2012.
(Logo: http://photos.prnewswire.com/prnh/20120229/NY61160LOGO )
Highlights for the third quarter include:
- 14% Increase in Large Scale Manufacturing Revenue Compared With Prior Year
- Third Consecutive Quarter of Year-Over-Year Improvement in Contract Margin
- Raises 2012 EPS and Royalty Revenue Guidance and Reaffirms and Tightens 2012 Contract Revenue Guidance
- Sequential Improvement in Discovery Services Revenue
- Positive Operating Cash Flow
- New Royalty Stream from a Long-Standing Customer on a Generic Commercial Product Launch Raising Overall Royalty Revenue for 2012
- Milestone Recognized for Selection of Fourth Compound for Advancement Under Terms of Bristol Myers Squibb (BMS) License Agreement
Third Quarter 2012 Results
Total revenue for the third quarter of 2012 was $55.8 million, an increase of 11% compared to the third quarter of 2011.
Total contract revenue for the third quarter of 2012 was $45.6 million, an increase of 4% compared to total contract revenue of $43.8 million reported in the third quarter of 2011. Total contract revenue encompasses revenue from AMRI’s Discovery Services, Development and Small-Scale Manufacturing, and Large-Scale Manufacturing business components.
- Discovery Services contract revenue for the third quarter was $8.9 million, consistent with amounts reported in 2011
- Development/Small-Scale Manufacturing contract revenue for the third quarter was $7.4 million, a decrease of 20% from $9.2 million in 2011
- Large-Scale Manufacturing contract revenue for the third quarter was $29.3 million, an increase of 14% from $25.7 million in 2011
Royalty revenue in the third quarter of 2012 was $9.4 million, an increase of 45% from $6.5 million in the third quarter of 2011. AMRI earns royalties from worldwide net sales of the non-sedating antihistamine Allegra® (Telfast® outside the United States), as well as certain generic forms of Allegra®, for patents relating to the active ingredient in Allegra®. Royalty revenue for the third quarter of 2012 also includes $3.3 million earned by the Company under a longstanding contract pursuant to which the Company provides the active pharmaceutical ingredient for a generic product, which is manufactured in the Company’s Rensselaer, N.Y. facility, and is also eligible for royalties on net sales of the final drug product. Royalty revenue from this product in the third quarter reflects launch quantity net sales of the product.
Total revenue in the third quarter of 2012 includes milestone revenue of $0.8 million resulting from the Company’s 2005 licensing agreement with BMS. This milestone recognizes the selection of a fourth compound for possible advancement.
Net loss under U.S. GAAP was $(2.1) million, or $(0.07) per basic and diluted share in the third quarter of 2012, compared to a net loss of $(5.9) million, or $(0.19) per basic and diluted share for the third quarter of 2011. Adjusted net loss for the third quarter of 2012 was break even, or $(0.00) per basic and diluted share, and excludes additional restructuring charges primarily related to the closure of our Hungary facility and certain executive transition costs. Adjusted net loss for the third quarter of 2011 was $(5.7) million or $(0.19) per basic and diluted share.
Year-to-Date
Total revenue for the nine-month period ended September 30, 2012 was $159.5 million, a decrease of $1.6 million or 1% compared to $161.1 million for the same period in 2011.
Total contract revenue for the first nine months of 2012 was $130.7 million, an increase of $0.5 million or 0.4% from $130.2 million for the same period in 2011.
- Contract revenue for Discovery Services in the nine-month period ended September 30, 2012 was $27.2 million, a decrease of 5% from $28.5 million in 2011.
- Contract revenue for Development/Small-Scale Manufacturing in the nine-month period ended September 30, 2012 was $25.2 million, a decrease of 12% from $28.7 million in 2011.
- Contract revenue for Large-Scale Manufacturing in the nine-month period ended September 30, 2012 was $78.3 million, an increase of 7% compared to $73 million 2011.
Recurring royalties for the first nine months of 2012 were $27.9 million, consistent with the first nine months of 2011. Recurring royalties from Allegra ® for this period were $24.6 million, a decrease of 12% compared to 2011. The remaining year-to-date royalty revenue is related to the generic launch discussed above.
Total revenue for the nine months ended September 30, 2012 and 2011 include milestone revenue of $0.8 million and $3 million, respectively, primarily from the Company’s 2005 licensing agreement with BMS.
Net loss under U.S. GAAP for the nine months ended September 30, 2012 was $(5.7) million or $(0.19) per basic and diluted share, compared to net loss of $(7.9) million or $(0.26) per basic and diluted share for the nine months ended September 30, 2011. Adjusted net income for the nine months ended September 30, 2012 was $2.4 million or $0.08 per basic and diluted share and excludes certain restructuring and asset impairment charges primarily related to our exit from the Hungary operation and executive transition costs incurred during the period. Adjusted net loss for the nine months ended September 30, 2011 was $(6.7) million or $(0.22) per basic and diluted share. For a reconciliation of net (loss) and (loss) per diluted share as reported to adjusted net income and earnings per diluted share for the 2012 and 2011 reporting periods, please see Table 1 at the end of this press release.
AMRI Chairman, President and CEO Thomas E. D’Ambra said, “The quarter marks year-over-year and sequential improvement in revenue for our contract services business driven by continued strength in our large scale manufacturing operations. Although contract service operating margins in the quarter were impacted by the underlying mix of services within each segment, this was offset by the favorable impact of royalties received on product sales from the commercial launch of an FDA approved generic product by one of our customers. On balance, we remain confident in our ability to drive improved financial performance given the positive underlying trends in our business, including continued improvement in customer orders and inquiries, the significant number of products in our pipeline approaching PDUFA dates over the next 24 months, and our ongoing commitment to optimizing our cost structure.”
Dr. D’Ambra continued, “SMARTSOURCING™ is a highly competitive, customer-centric approach for serving clients that has enabled AMRI to strengthen its customer base with global pharmaceutical and biotechnology companies, government agencies and academic institutions. In addition to the recently announced agreement with Knopp Biosciences and the multi-year extension of our agreement with Shire, we are actively pursuing several other opportunities with existing and new customers that could potentially provide AMRI with a stronger, more diverse business base as we enter 2013. Although the global economy remains challenging, our outlook for the market remains unchanged with anticipated growth in R&D spending and incremental increases in the level of outsourcing across the biopharmaceutical industry over the coming year. With SMARTSOURCING™, which empowers clients to better balance risk, enhance flexibility, and obtain tailored solutions that meet their specific needs, AMRI is well positioned to benefit from these market trends.”
Liquidity and Capital Resources
At September 30, 2012, AMRI had cash, cash equivalents and restricted cash of $20.7 million, compared to $18.4 million at June 30, 2012. These amounts include $5 million of restricted cash, which was pledged to collateralize the Company’s term loan and line of credit.
Total debt at September 30, 2012 was $8 million, unchanged from June 30, 2012. Cash, cash equivalents and restricted cash, net of debt, were $12.7 million at September 30, 2012, compared to $10.4 million at June 30, 2012. The increase in cash and cash equivalents for the quarter ended September 30, 2012 was comprised of cash from operations of $4.5 million, partially offset by capital expenditures of $2.7 million. Total common shares outstanding, net of treasury shares, were 30,924,980 at September 30, 2012.
2012 Financial Guidance
AMRI Chief Financial Officer and Treasurer Michael Nolan provided contract revenue guidance for the fourth quarter and full year 2012. “Building off the momentum we saw in large scale manufacturing in the third quarter, we anticipate sequential growth in fourth quarter contract revenue with a range of $50 to 56 million. With this outlook we are tightening our range and reconfirming the top end of our full year contract revenue guidance at $180 – $186 million, an increase of up to 10% versus 2011. Based on the addition of a new royalty stream, we expect total royalty revenue to increase by $2 million to a range of $34 to $36 million. Considering this we have increased our full year adjusted earnings per diluted share estimate from a range of $0.10 to $0.16 to a range of $0.16 to $0.20. To reach this we expect fourth quarter adjusted earnings per diluted share in the range of $0.08 to $0.12.”
Mr. Nolan continued, “AMRI continues to benefit from previous restructuring actions resulting in both improvements in contract margins and lower SG&A and R&D spend. In addition, operating cash flow was $4.5 million for the quarter, which represents continued improvement in the Company’s financial position. Extending existing relationships and securing new contracts along with the announcement of our new royalty stream demonstrates the value AMRI brings to our customers.”
Recent Highlights
Recent noteworthy announcements or milestones at AMRI include the following:
- The appointment of Michael Nolan Vice President, Chief Financial Officer and Treasurer
- The promotion of Steven R. Hagen, Ph.D., to Senior Vice President of Pharmaceutical Development and Manufacturing
- A five-year extension of an API supply agreement with Shire Pharmaceuticals
- A strategic contract with Knopp Biosciences
- The promotion of Daniel Conlon to Senior Director of Business Development
Third Quarter Conference Call
The Company will hold a conference call at 10:00 a.m. ET on November 6, 2012 to discuss its quarterly results, business highlights and prospects. During the conference call, the Company may discuss information not previously disclosed to the public. The conference call can be accessed by dialing 1-888-364-3108 (domestic calls) or +1-719-457-2645 (international calls) at 9:45 a.m. ET and entering passcode 8248928. The webcast will be available live via the Internet and can be accessed on the Company’s website at www.amriglobal.com .
Replays of the webcast can also be accessed for up to 90 days after the call via the investor area of the Company’s website at www.amriglobal.com/investor_relations.
About AMRI
Albany Molecular Research, Inc. (AMRI) is a global contract research and manufacturing organization offering customers fully integrated drug discovery, development, and manufacturing services. For over 21 years, AMRI has demonstrated its adaptability as the pharmaceutical and biotechnology industries have undergone tremendous change in response to multiple challenges. This experience, a track record of success, and locations in the United States, Europe and Asia now provides our customers with SMARTSOURCING™, a full range of value-added opportunities providing customers informed decision-making, enhanced efficiency and more successful outcomes at all stages of the pipeline. AMRI has also successfully partnered R&D programs and is actively seeking to out-license its remaining programs for further development. For press releases and additional information about the Company, please visit www.amriglobal.com.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. These statements include, but are not limited to, statements regarding the Company’s estimates of revenue and earnings per share for the fourth quarter and full year 2012, statements made by the Company’s chief executive officer and chief financial officer, including statements under the caption “2012 Financial Guidance,” statements regarding the cost saving expected from certain restructuring activities, statements regarding the strength of the Company’s business and prospects including the expected revenue to be derived from the sale of the Allegra and other royalty bearing products, and statements concerning the Company’s momentum and long-term growth. Readers should not place undue reliance on our forward-looking statements. The Company’s actual results may differ materially from such forward-looking statements as a result of numerous factors, some of which the Company may not be able to predict and may not be within the Company’s control. Factors that could cause such differences include, but are not limited to, the Company’s ability to attract and retain experienced scientists, trends in pharmaceutical and biotechnology companies’ outsourcing of chemical research and development, including softness in these markets, sales of Allegra ® and the impact of the “at-risk” launch of generic Allegra ® and the conversion by Sanofi of Allegra to an OTC product on the Company’s receipt of significant royalties under the Allegra ® license agreement, the over-the-counter sale of Claritin, and competitive alternatives, including generic products for the treatment of allergies and the risk of new product introductions for the treatment of allergies including generic forms of Allegra ® , the risk that the Company will not be able to replicate either in the short or long term the revenue stream that has been derived from the royalties payable under the Allegra ® license and other royalty-bearing agreements, the success of the Company’s collaborations with customers including the collaboration with Bristol-Myers Squibb Company related to biogenic amine reuptake inhibitors, the risk that clients may terminate or reduce demand under any strategic or multi-year deal, the Company’s ability to enforce its intellectual property and technology rights, the Company’s ability to successfully develop novel compounds and lead candidates in its collaborative arrangements, the Company’s ability to integrate the acquisitions closed during 2010 and make such acquisitions accretive to the Company’s business model, the Company’s ability to take advantage of proprietary technology and expand the scientific tools available to it, the ability of the Company’s strategic investments and acquisitions to perform as expected, as well as those risks discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2011 as filed with the Securities and Exchange Commission on March 15, 2012, and the Company’s other SEC filings. Revenue and other financial guidance offered by senior management today represent a point-in-time estimate and are based on information as of the date of this press release. Senior management has made numerous assumptions in providing this guidance which, while believed to be reasonable, may not prove to be accurate. Numerous factors, including those noted above, may cause actual results to differ materially from the guidance provided. The Company expressly disclaims any current intention or obligation to update the guidance provided or any other forward-looking statement in this press release to reflect future events or changes in facts assumed for purposes of providing this guidance or otherwise affecting the forward-looking statements contained in this press release.
Non-GAAP Adjustment Items
To supplement our financial results prepared in accordance with U.S. GAAP, we have presented non-GAAP measures of income (loss) from operations, net (loss) income and (loss) earnings per diluted share adjusted to exclude certain asset impairment charges, restructuring charges, executive transition costs, FDA remediation costs, purchase accounting adjustments, deferred financing write-offs, real property tax adjustments, and arbitration charges in the 2012 and 2011 periods. We believe presentation of these non-GAAP measures enhances an overall understanding of our historical financial performance because we believe they are an indication of the performance of our base business. Management uses these non-GAAP measures as a basis for evaluating our financial performance as well as for budgeting and forecasting of future periods. For these reasons, we believe they can be useful to investors. The presentation of this additional information should not be considered in isolation or as a substitute for income from operations, net income or earnings per diluted share prepared in accordance with U.S. GAAP.
Albany Molecular Research, Inc. |
|||||||||
Condensed Consolidated Statements of Operations (unaudited) |
|||||||||
Three Months Ended |
Nine Months Ended |
||||||||
(Dollars in thousands, except for per share data) |
Sept. 30, 2012 |
Sept. 30, 2011 |
Sept. 30, 2012 |
Sept. 30, 2011 |
|||||
Contract revenue |
$ 45,627 |
$ 43,771 |
$ 130,727 |
$ 130,199 |
|||||
Recurring royalties |
9,393 |
6,458 |
27,907 |
27,854 |
|||||
Milestone revenue |
750 |
─ |
840 |
3,000 |
|||||
Total revenue |
55,770 |
50,229 |
159,474 |
161,053 |
|||||
Cost of contract revenue |
43,660 |
45,388 |
119,581 |
128,116 |
|||||
Technology incentive award |
621 |
646 |
2,473 |
2,839 |
|||||
Research and development |
196 |
1,608 |
800 |
6,122 |
|||||
Selling, general and administrative |
10,774 |
10,504 |
30,461 |
31,702 |
|||||
Restructuring charges |
1,616 |
─ |
3,743 |
951 |
|||||
Impairment charges |
─ |
─ |
3,967 |
─ |
|||||
Arbitration charge |
─ |
─ |
─ |
127 |
|||||
Total operating expenses |
56,867 |
58,146 |
161,025 |
169,857 |
|||||
Loss from operations |
(1,097) |
(7,917) |
(1,551) |
(8,804) |
|||||
Interest expense, net |
(109) |
(205) |
(364) |
(327) |
|||||
Other (expense) income, net |
(445) |
547 |
(1,101) |
133 |
|||||
Loss before income taxes |
(1,651) |
(7,575) |
(3,016) |
(8,998) |
|||||
Income tax expense (benefit) |
492 |
(1,723) |
2,677 |
(1,111) |
|||||
Net loss |
$ (2,143) |
$ (5,852) |
$ (5,693) |
$ (7,887) |
|||||
Basic and diluted loss per share |
$ (0.07) |
$ (0.19) |
$ (0.19) |
$ (0.26) |
|||||
Albany Molecular Research, Inc. |
||||
Selected Consolidated Balance Sheet Data |
||||
(unaudited) |
||||
Sept. 30, 2012 |
Dec. 31, 2011 |
|||
(Dollars in thousands, except for per share data) |
||||
Cash and cash equivalents |
$ 15,673 |
$ 19,984 |
||
Accounts receivable, net |
35,180 |
30,437 |
||
Royalty income receivable |
9,260 |
6,819 |
||
Inventory |
33,156 |
26,004 |
||
Total current assets |
107,387 |
100,560 |
||
Restricted cash |
5,000 |
─ |
||
Property and equipment, net |
141,495 |
149,796 |
||
Total assets |
264,467 |
263,067 |
||
Total current liabilities |
38,149 |
37,976 |
||
Longterm debt, excluding current installments |
7,407 |
3,003 |
||
Total liabilities |
59,906 |
56,633 |
||
Total stockholders’ equity |
204,561 |
206,434 |
||
Total liabilities and stockholders’ equity |
264,467 |
263,067 |
||
Table 1: Reconciliation of third quarter 2012 and 2011 reported income (loss) from operations, net loss and loss per diluted share to adjusted income (loss) from operations, adjusted net (loss) income and adjusted (loss) earnings per share:
Third Quarter |
Third Quarter |
Nine Months Ended |
Nine Months Ended |
||||||
Loss from operations, as reported |
$ (1,097) |
$ (7,917) |
$ (1,551) |
$ (8,804) |
|||||
Impairment (recoveries) charges |
– |
– |
3,908 |
– |
|||||
Restructuring charges |
1,616 |
– |
3,743 |
951 |
|||||
Executive transition costs |
1,001 |
– |
1,001 |
– |
|||||
FDA remediation costs |
– |
200 |
– |
615 |
|||||
Arbitration charges |
– |
– |
– |
127 |
|||||
Real property tax credit adjustment |
– |
– |
– |
375 |
|||||
Income (loss) from operations, as adjusted |
$ 1,520 |
$ (7,717) |
$ 7,160 |
$ (6,736) |
|||||
Net loss, as reported |
$ (2,143) |
$ (5,852) |
$ (5,693) |
$ (7,887) |
|||||
Adjustments, net of tax: |
|||||||||
Impairment (recoveries) charges |
– |
– |
3,870 |
– |
|||||
Restructuring charges |
1,485 |
– |
3,557 |
627 |
|||||
Executive transition costs |
651 |
– |
651 |
– |
|||||
FDA remediation costs |
– |
130 |
(16) |
400 |
|||||
Arbitration charges |
– |
– |
– |
83 |
|||||
Real property tax credit adjustment |
– |
– |
– |
245 |
|||||
Purchase accounting adjustments |
– |
– |
(102) |
(190) |
|||||
Write-off of deferred financing |
– |
– |
120 |
– |
|||||
Net (loss) income, as adjusted |
$ (7) |
$ (5,722) |
$ 2,387 |
$ (6,722) |
|||||
Loss per diluted share, as reported |
$ (0.07) |
$ (0.19) |
$ (0.19) |
$ (0.26) |
|||||
Adjustments , net of tax: |
|||||||||
Impairment (recoveries) charges |
– |
– |
0.13 |
– |
|||||
Restructuring charges |
0.05 |
– |
0.12 |
0.02 |
|||||
Executive transition costs |
0.02 |
0.02 |
|||||||
FDA remediation costs |
– |
– |
– |
0.01 |
|||||
Arbitration charges |
– |
– |
– |
– |
|||||
Real property tax credit adjustment |
– |
– |
– |
0.01 |
|||||
Purchase accounting adjustments |
– |
– |
– |
– |
|||||
Write-off of deferred financing |
– |
– |
– |
– |
|||||
Net income (loss), as adjusted |
$ 0.00 |
$ (0.19) |
$ 0.08 |
$ (0.22) |
|||||
Rosetta Genomics (ROSG) New York State Grants Final Approval for miRview®
New York State Grants Final Approval for miRview® lung; Expands Access for Rosetta Genomics’ microRNA Diagnostic for Identification of Four Major Subtypes of Lung Cancer
New, Targeted Therapies Make Accurate Classification of Lung Cancer Increasingly Important
PHILADELPHIA and REHOVOT, Israel, Nov. 6, 2012 /PRNewswire/ — Rosetta Genomics (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostic assays, announces that the New York State Department of Health has given the Company final approval for its miRview® lung assay following conditional approval issued in June 2012. With this final approval, Rosetta Genomics can continue to offer the miRview® lung assay in all 50 U.S. states. New York is the only U.S. state that requires an independent regulatory review process for laboratory-developed tests.
miRview® lung is the Company’s proprietary microRNA-based assay that can accurately differentiate between the four main subtypes of lung cancer using small amounts of tumor cells.
“We are pleased to have final New York State approval for our micro-RNA-based miRview lung assay. This represents an important validation of our technology as many jurisdictions around the world recognize the rigor of review in the state of New York. With the introduction of targeted lung cancer therapies, along with new targeted drugs entering the clinical arena, accurate classification of lung cancer is becoming increasingly important to better assess efficacy profiles and to enhance treatment strategies,” noted Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics. “We look forward to continuing to offer this important assay to the benefit of patients and physicians throughout the U.S. where, according to the National Cancer Institute, there are an estimated 226,000 new cases of lung cancer and an estimated 160,000 lung cancer related deaths expected in 2012.”
About miRview® lung
miRview lung accurately identifies the four main subtypes of lung cancer with a sensitivity of 95%, using very small pre-operative biopsies such as fine needle aspirate and cytological samples. The assay differentiates neuroendocrine tumors from non-small cell lung tumors (NSCLC), and then further subtypes neuroendocrine tumors into small cell lung cancer and carcinoid; and subtypes NSCLC tumors into squamous and non-squamous.
About miRview® Products
miRview® products are a series of microRNA-based molecular diagnostic products offered by Rosetta Genomics. The miRview® mets² assay accurately identifies the primary tumor type in patients with primary or metastatic Cancer of Unknown or Uncertain primary (CUP). miRview® meso diagnoses mesothelioma, a cancer connected to asbestos exposure. miRview® lung accurately identifies the four main subtypes of lung cancer. miRview® kidney accurately classifies the four most common kidney tumors: clear cell renal cell carcinoma (RCC), papillary RCC, chromophobe RCC and oncocytoma. miRview® assays are designed to provide objective diagnostic data; it is the treating physician’s responsibility to diagnose and administer the appropriate treatment. In the U.S. alone, Rosetta Genomics estimates that 200,000 patients a year may benefit from the miRview® mets² test, 60,000 from miRview® meso, 54,000 from miRview® kidney and 226,000 patients from miRview® lung. The Company’s assays are offered directly by Rosetta Genomics in the U.S., and through distributors around the world. For more information, please visit www.mirviewdx.com. Parties interested in ordering the test can contact Rosetta Genomics at (215) 382-9000 ext. 309.
About Rosetta Genomics
Rosetta develops and commercializes a full range of microRNA-based molecular diagnostics. Founded in 2000 Rosetta’s integrative research platform combining bioinformatics and state-of-the-art laboratory processes has led to the discovery of hundreds of biologically validated novel human microRNAs. Building on its strong patent position and proprietary platform technologies, Rosetta is working on the application of these technologies in the development and commercialization of a full range of microRNA-based diagnostic tools. Rosetta’s miRview® product line is commercially available through its Philadelphia-based CAP-accredited, CLIA-certified lab. Frost & Sullivan recognized Rosetta Genomics with the 2012 North American Next Generation Diagnostics Entrepreneurial Company of the Year Award.
Forward-Looking Statement Disclaimer
Various statements in this release concerning Rosetta’s future expectations, plans and prospects, including without limitation, statements relating to the market acceptance of Rosetta’s miRview® assays, particularly miRview® lung, as well as the increasing importance of accurate classification and subtyping of lung cancer and Rosetta’s capitalization of its microRNA platform constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those risks more fully discussed in the “Risk Factors” section of Rosetta’s Annual Report on Form 20-F for the year ended December 31, 2011 as filed with the SEC. In addition, any forward-looking statements represent Rosetta’s views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Rosetta does not assume any obligation to update any forward-looking statements unless required by law.
Company Contact: |
Investor Contacts: |
Rosetta Genomics |
LHA |
Ken Berlin, President & CEO |
Anne Marie Fields |
(215) 382-9000, ext. 326 |
(212) 838-3777 |
investors@rosettagenomics.com |
afields@lhai.com |
or |
|
Bruce Voss |
|
(310) 691-7100 |
|
bvoss@lhai.com |
MEI Pharma (MEIP) Reports New Data Showing High Response Rates in Clinical Trial
MEI Pharma Reports New Data Showing High Response Rates in Clinical Trial of Pracinostat and Azacitidine in Myelodysplastic Syndrome
Data Accepted for Presentation at American Society of Hematology Annual Meeting
SAN DIEGO, Nov. 6, 2012 /PRNewswire/ — MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, announced today that preliminary data from a pilot Phase II clinical trial of the Company’s investigational oral histone deacetylase (HDAC) inhibitor, Pracinostat, in combination with azacitidine in patients with advanced myelodysplastic syndrome (MDS) has been accepted for poster presentation at the American Society of Hematology Annual Meeting on December 10, 2012.
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An abstract of the presentation, entitled “Very high rates of clinical and cytogenetic response with the combination of the histone deacetylase inhibitor Pracinostat (SB939) and 5-azacitidine in high-risk myelodysplastic syndrome,” submitted by Dr. Quintas-Cardama and Dr. Garcia-Manero of the MD Anderson Cancer Center, is now available online at www.hematology.org. The poster will be presented at 6:00 p.m. Eastern time from Hall B1-B2, Level 1, Building B of the Georgia World Congress Center in Atlanta.
“We are very encouraged not only by the response rates reported to date, but also by the rapid appearance of the responses with the combination of Pracinostat and azacitidine,” said Daniel P. Gold, Ph.D., President and Chief Executive Officer of MEI Pharma. “These data are particularly compelling given that most patients in the study had treatment-related MDS and expressed high-risk cytogenetic abnormalities, both of which carry a poor prognosis. With these data in hand, combined with the capital raise we announced yesterday, we expect to be in a position to rapidly advance to the next stage of development and initiate a randomized Phase II trial of Pracinostat in combination with azacitidine in patients with MDS by the second quarter of next year.”
About Pracinostat
Pracinostat is a selective inhibitor of a group of enzymes called histone deacetylases (HDAC). There are currently two HDAC inhibitors approved by the U.S. Food and Drug Administration (FDA) for the treatment of cutaneous T-cell lymphoma, one of which is also approved for the treatment of peripheral T-cell lymphoma. Pracinostat has shown evidence of single-agent activity in multiple clinical trials, including advanced hematologic malignancies such as MDS, acute myeloid leukemia and myelofibrosis. Pracinostat has also demonstrated pre-clinical activity in hematologic disorders and solid tumors when used alone or in combination with a wide range of therapies in laboratory studies. Pracinostat has been generally well tolerated in clinical testing of more than 150 patients, with readily manageable side effects often associated with drugs of this class. The most common adverse event (all grades) is fatigue. Pracinostat has not been approved by the FDA for commercial distribution.
About MEI Pharma
MEI Pharma, Inc. (Nasdaq: MEIP) is a San Diego-based oncology company focused on the clinical development of novel therapies for cancer. The Company’s clinical development pipeline includes lead drug candidate Pracinostat, a potential best-in-class HDAC inhibitor. Pracinostat has been tested in multiple Phase I and exploratory Phase II clinical trials, including advanced hematologic malignancies such as MDS, acute myeloid leukemia and myelofibrosis. The Company expects to initiate a randomized Phase II trial of Pracinostat in combination with azacitidine in patients with MDS by the second quarter of 2013. In addition, MEI Pharma is developing two drug candidates derived from its isoflavone-based technology platform, ME-143 and ME-344. Results from a Phase I trial of intravenous ME-143 in heavily treated patients with solid refractory tumors were presented at the American Society of Clinical Oncology Annual Meeting in June 2012. A Phase I clinical trial of intravenous ME-344 in patients with solid refractory tumors is ongoing. For more information, go to www.meipharma.com.
Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical trials and approved by the FDA as being safe and effective for the intended use. Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management’s current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval, or the failure to obtain such approval, of our product candidates; uncertainties or differences in interpretation in clinical trial results; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.
Cardium Therapeutics (CXM) on European Union’s First Gene Therapy Approval
SAN DIEGO, Nov. 6, 2012 /PRNewswire/ — Cardium Therapeutics (NYSE MKT: CXM) today reported that uniQure’s Glybera® (alipogene tiparvovec) approval by the European Commission, the first gene therapy approval by a major health regulatory authority, represents a significant milestone and validation for the gene therapy industry. Glybera® is a treatment for patients diagnosed with an inherited metabolic disease called familial lipoprotein lipase deficiency (LPLD or familial hyperchylomicronemia), who suffer from severe or multiple pancreatitis attacks despite dietary fat restrictions. The European Commission’s marketing authorization of Glybera covers all 27 European member states and uniQure plans to apply for regulatory approval in the U.S., Canada and other countries.
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“The EU approval of Glybera represents a major milestone for the global gene therapy industry,” stated Christopher J. Reinhard, Chairman and CEO of Cardium. “This is an important step forward for our field and the millions of patients expected to benefit from new and innovative gene-based therapeutics. Gene therapy offers the opportunity to simplify treatments for serious medical problems and to develop new products for which there are no current medical treatments.”
Cardium’s late-stage gene therapy Generx product candidate (Ad5FGF-4) is a disease-modifying interventional cardiology biologic being developed as a one-time non-surgical treatment for patients with coronary artery disease. Generx can be delivered using a standard cardiac catheter and is capable of promoting and enhancing cardiac perfusion in the heart through the enlargement of pre-existing collateral arterioles (arteriogenesis) and the formation of new capillary vessels (angiogenesis).
About Cardium
Cardium is an asset-based health sciences and regenerative medicine company focused on the acquisition and strategic development of innovative products and businesses with the potential to address significant unmet medical needs and having definable pathways to commercialization, partnering or other economic monetizations. Cardium’s current portfolio includes the Tissue Repair Company, Cardium Biologics, and the Company’s newly-acquired To Go Brands® nutraceutical business. The Company’s lead commercial product, Excellagen® topical gel for wound care management, has received FDA clearance for marketing and sale in the United States. Cardium’s lead clinical development product candidate Generx® is a DNA-based angiogenic biologic intended for the treatment of patients with myocardial ischemia due to coronary artery disease. To Go Brands® develops, markets and sells dietary supplements through established regional and national retailers. In addition, consistent with its capital-efficient business model, Cardium continues to actively evaluate new technologies and business opportunities. News from Cardium is located at www.cardiumthx.com.
Forward-Looking Statements
Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from expectations. For example, there can be no assurance that the approval of a gene therapy in Europe will improve the prospects for other gene therapy products; that results or trends observed in one clinical study or procedure will be reproduced in subsequent studies or in actual use; that new clinical studies will be successful or will lead to approvals or clearances from health regulatory authorities, or that approvals in one jurisdiction will help to support studies or approvals elsewhere; that the company can attract suitable commercialization partners for our products or that we or partners can successfully commercialize them; that our product or product candidates will not be unfavorably compared to competitive products that may be regarded as safer, more effective, easier to use or less expensive or blocked by third party proprietary rights or other means; that the products and product candidates referred to in this report or in our other reports will be successfully commercialized and their use reimbursed, or will enhance our market value; that our To Go Brands business can be successfully integrated and expanded; that new product opportunities or commercialization efforts will be successfully established; that third parties on whom we depend will perform as anticipated; that we can raise sufficient capital from partnering, monetization or other fundraising transactions to maintain our stock exchange listing or adequately fund ongoing operations; or that we will not be adversely affected by these or other risks and uncertainties that could impact our operations, business or other matters, as described in more detail in our filings with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.
Copyright 2012 Cardium Therapeutics, Inc. All rights reserved.
For Terms of Use Privacy Policy, please visit www.cardiumthx.com.
Cardium Therapeutics®, Generx®,Cardionovo™, Tissue Repair™, Gene Activated Matrix™, GAM™, Excellagen®, Excellarate™, Osteorate™, MedPodium®, Appexium®, Linée®, Alena®, Cerex®, D-Sorb™, Neo-Energy®, Neo-Carb Bloc®, Neo-Chill™, and Nutra-Apps® are trademarks of Cardium Therapeutics, Inc. or Tissue Repair Company. To Go Brands® is a trademark of To Go Brands, Inc.
(Glybera® and other trademarks belong to their respective owners)
FuelCell Energy (FCEL) Announces Manufacturing Agreement With Partner, POSCO Energy
- $26 million license payment for manufacturing rights
- POSCO Energy to pay royalties for each fuel cell power plant sold over the next 15 years
DANBURY, Conn., Nov. 5, 2012 (GLOBE NEWSWIRE) — FuelCell Energy, Inc. (Nasdaq:FCEL), a global leader in the design, manufacture, operation and service of ultra-clean, efficient and reliable fuel cell power plants, today announced the execution of a series of strategic initiatives with its South Korean partner, POSCO Energy, to expand the market for stationary fuel cell power plants in Asia, including a license agreement for POSCO Energy to manufacture Direct FuelCell® (DFC®) power plants in South Korea and sell throughout Asia. POSCO Energy is Korea’s largest independent power producer and is a subsidiary of POSCO, a leading global steel producer.
“With growing demand in South Korea and strong interest in Asian markets for ultra-clean distributed power generation, manufacturing in South Korea is necessary to meet customer expectations of lead times and costs,” said Jung-Gon Kim, Senior Vice President, POSCO Energy. “Local manufacturing is a cornerstone of our growth plans in South Korea and we will continue to work closely with FuelCell Energy to develop other Asian markets.”
The Cell Technology Transfer and License Agreement provides POSCO Energy the rights to manufacture carbonate fuel cell components in South Korea based on DFC technology and grants commercial rights to Asian markets. The agreement harmonizes two prior license agreements so that POSCO Energy has rights to manufacture the entire carbonate DFC power plant.
“This license agreement enables our partnership to expand global market growth while leveraging our respective capital and local production capacity,” said Chip Bottone, President and Chief Executive Officer, FuelCell Energy, Inc. “POSCO Energy will manufacture in South Korea for the South Korean market and export markets in Asia.”
A production facility will be built at the POSCO Energy campus in Pohang, South Korea to produce up to 140 megawatts of fuel cell components annually, with equipment initially procured for an expected annual production volume of 70 megawatts. Construction will begin in early 2013 and fuel cell component production is expected to start in late 2014 or early 2015. FuelCell Energy will collaborate with POSCO Energy under the license agreement to provide design and procurement assistance for the facility. POSCO Energy has already invested in fuel cell module assembly capabilities and balance of plant manufacturing at its Pohang campus.
“A second source of global supply and production capacity for our DFC fuel cell modules is important to project investors and customers,” commented Michael Bishop, Chief Financial Officer, FuelCell Energy, Inc. “This licensing agreement is a key development milestone for accelerating global expansion of highly efficient and environmentally friendly fuel cell power plants.”
The License Agreement payments total $18 million and the amendment to prior agreements totals $8 million. The initial payment of $10 million was received on November 1, 2012. POSCO Energy will also pay a 3.0 percent royalty to FuelCell Energy for each power plant built and sold by POSCO Energy during the next 15 years. This royalty is expected to develop into a consistent and growing revenue stream as the Asian fuel cell market expands. The license agreement may be extended for two additional terms of five years each by mutual agreement.
DFC power plants excel at solving energy, environmental and business problems by providing ultra clean, efficient and reliable distributed power generation solutions. Direct FuelCells combine a fuel such as natural gas or renewable biogas with oxygen from the ambient air to efficiently produce ultra-clean electricity and usable high quality heat through an electrochemical process. DFC power plants emit virtually no pollutants due to the absence of combustion. Avoiding the emission of nitrogen oxide (NOx), sulfur dioxide (SOx) and particulate matter supports clean air regulations and benefits public health. The high efficiency of the fuel cell power generation process reduces fuel costs and carbon emissions, and producing both electricity and heat from the same unit of fuel further supports favorable economics while also promoting sustainability.
POSCO Energy is a wholly owned subsidiary of POSCO, a leading global steel producer headquartered in Pohang, South Korea. With annual revenues of approximately $1.8 billion in 2011, POSCO Energy is the largest independent power producer in South Korea with power generation assets that provide power to POSCO and to the electric grid. POSCO Energy also develops and sells new and renewable power generation facilities and owns power generation assets in Southeast Asian countries including Indonesia and Vietnam as well as a solar park in Nevada, USA. The parent, POSCO, is publicly held, trading on the Korean Stock Exchange under the symbol 005490 and on the New York Stock Exchange under symbol PKX.
About FuelCell Energy
Direct FuelCell® power plants are generating ultra-clean, efficient and reliable power at more than 50 locations worldwide. With approximately 300 megawatts of power generation capacity installed or in backlog, FuelCell Energy is a global leader in providing ultra-clean baseload distributed generation to utilities, industrial operations, universities, municipal water treatment facilities, government installations and other customers around the world. The Company’s power plants have generated more than one billion kilowatt hours of ultra-clean power using a variety of fuels including renewable biogas from wastewater treatment and food processing, as well as clean natural gas.For more information please visit our website at www.fuelcellenergy.com
See us on YouTube at www.youtube.com/user/FuelCellEnergyInc?feature=watch
The FuelCell Energy, Inc. logo is available athttp://www.globenewswire.com/newsroom/prs/?pkgid=3284
This news release contains forward-looking statements, including statements regarding the Company’s plans and expectations regarding the continuing development, commercialization and financing of its fuel cell technology and business plans. All forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause such a difference include, without limitation, whether the Company is able to reach definitive agreements on the terms contemplated in the memorandums of agreement with POSCO Energy, general risks associated with product development, manufacturing, changes in the regulatory environment, customer strategies, potential volatility of energy prices, rapid technological change, competition, and the Company’s ability to achieve its sales plans and cost reduction targets, as well as other risks set forth in the Company’s filings with the Securities and Exchange Commission. The forward-looking statements contained herein speak only as of the date of this press release. The Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statement to reflect any change in the Company’s expectations or any change in events, conditions or circumstances on which any such statement is based.
Direct FuelCell, DFC, DFC/T, DFC-H2 and FuelCell Energy, Inc. are all registered trademarks of FuelCell Energy, Inc. DFC-ERG is a registered trademark jointly owned by Enbridge, Inc. and FuelCell Energy, Inc.
CONTACT: FuelCell Energy, Inc. Kurt Goddard, Vice President Investor Relations 203-830-7494 ir@fce.com
Entree Gold (EGI) Provides Update on Oyu Tolgoi Power Purchase Agreement
VANCOUVER, BRITISH COLUMBIA — (Marketwire) — 11/05/12 — Entree Gold Inc. (TSX:ETG)(NYSE MKT:EGI)(FRANKFURT:EKA) (“Entree” or the “Company”) is pleased to announce that the power supply deal for the Oyu Tolgoi mine in Mongolia has been finalized. Turquoise Hill Resources announced today that Oyu Tolgoi LLC has signed a binding power purchase agreement with the Inner Mongolia Power Corporation. This agreement is a critical milestone in the development of the Oyu Tolgoi mining complex.
Turquoise Hill stated that finalization of the power purchase agreement will enable Oyu Tolgoi to complete commissioning leading to the first production of copper-gold concentrate. Oyu Tolgoi is expected to begin a seven-week commissioning of the ore-processing equipment within the next few weeks. First concentrate production will follow within one month and the commencement of commercial production is expected three to five months later.
Greg Crowe, Entree’s President and CEO commented, “On October 9, 2012, Turquoise Hill announced that construction of the power transmission infrastructure has been completed and the power lines are ready for use. Conclusion of the power purchase agreement is the final step to securing the initial supply of electricity to the nearly-completed mine. Rio Tinto, Turquoise Hill and Oyu Tolgoi LLC are reportedly on track to bring the first phase of the world-class Oyu Tolgoi mine into production in the first half of 2013. The commencement of commercial production from the open pits will be vital to the further development of Mongolia’s economy.”
Lift 1 of the Entree-Oyu Tolgoi LLC joint venture’s Hugo North Extension deposit is included in the second phase of development. Entree has a carried interest in the Hugo North Extension deposit and the much larger Heruga deposit, both of which form part of the Oyu Tolgoi mining complex. First development production on the joint venture property is expected as early as 2015.
ABOUT ENTREE GOLD INC.
Entree Gold Inc. is a Canadian mineral exploration company balancing opportunity and risk with key assets in Mongolia and Nevada. As a joint venture partner with a carried interest on a portion of the Oyu Tolgoi mining complex in Mongolia, Entree Gold has a unique opportunity to participate in one of the world’s largest copper-gold projects managed by one of the premier mining companies – Rio Tinto. Oyu Tolgoi, with its series of deposits containing copper, gold and molybdenum, has been under exploration and development since the late 1990s. Phase 1 is on the verge of production, and Entree Gold could see first development production from the joint venture ground as early as 2015.
In addition to being on the path to production in Mongolia, Entree Gold has been advancing its Ann Mason Project in one of the world’s most favourable mining jurisdictions, Nevada. The Ann Mason Project hosts the sizeable Ann Mason copper and molybdenum porphyry deposit as well as the Blue Hill copper deposit within the rejuvenated Yerington copper camp. Based on the PEA announced in October, 2012, the Ann Mason deposit is expected to yield a base case pre-tax, 7.5% net present value of $1.11 billion and an internal rate of return of 14.8%, using assumed copper, molybdenum, gold and silver prices of $3.00/lb, $13.50/lb, $1,200/oz and $22/oz, respectively(i).
Rio Tinto and Turquoise Hill Resources (formerly Ivanhoe Mines) are major shareholders of Entree, holding approximately 13% and 11% of issued and outstanding shares, respectively. Rio Tinto, through its majority ownership of Turquoise Hill Resources, beneficially owns 23.6% of Entree’s issued and outstanding shares.
(i)Readers are cautioned that the PEA on the Ann Mason deposit is preliminary in nature and includes inferred mineral resources that are considered too speculative geologically to have the economic considerations applied to them that would enable them to be categorized as mineral reserves, and there is no certainty that the PEA will be realized.
This News Release contains forward-looking statements and forward-looking information (together, “forward-looking statements”) within the meaning of applicable securities laws and the United States Private Securities Litigation Reform Act of 1995, with respect to future mineral production, anticipated business activities, corporate strategies and future financial performance. In certain cases, forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not expect”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, or “does not anticipate” or “believes” or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved”. While Entree has based these forward-looking statements on its expectations about future events as at the date that such statements were prepared, the statements are not a guarantee of Entree’s future performance and are subject to risks, uncertainties, assumptions and other factors which could cause actual results to differ materially from future results expressed or implied by such forward-looking statements. Such factors and assumptions include, amongst others, that the size, grade and continuity of deposits and resource and reserve estimates have been interpreted correctly from exploration results; that the prices of copper, gold, silver and molybdenum and foreign exchange rates will remain relatively stable; the effects of general economic conditions, including inflation; future actions by Rio Tinto, Turquoise Hill Resources, Oyu Tolgoi LLC and government authorities including the Government of Mongolia; the availability of capital; that applicable legislation, including legislation with respect to taxation, will not materially change; uncertainties associated with legal proceedings and negotiations; and misjudgements in the course of preparing forward-looking statements.
In addition, there are also known and unknown risk factors which may cause the actual results, performances or achievements of Entree to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include, among others, risks related to international operations, including legal and political risk in Mongolia; recent global financial conditions; actual results of current exploration activities; changes in project parametres as plans continue to be refined; inability to upgrade inferred mineral resources to indicated or measured mineral resources; inability to convert mineral resources to mineral reserves; conclusions of economic evaluations; future prices of copper, gold, silver and molybdenum; possible variations in ore reserves, grade recovery and rates; failure of plant, equipment or processes to operate as anticipated; accidents, labour disputes and other risks of the mining industry; delays in obtaining government approvals, permits or licences or financing or in the completion of development or construction activities; environmental risks; title disputes; limitations on insurance coverage; as well as those factors described in the Company’s Annual Information Form for the financial year ended December 31, 2011, dated March 29, 2012 and the Company’s most recent Management’s Discussion and Analysis filed with the Canadian Securities Administrators and available at www.sedar.com. Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results not to be as anticipated, estimated or intended. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements. The Company is under no obligation to update or alter any forward-looking statements except as required under applicable securities laws.
Contacts:
Entree Gold Inc.
Mona Forster
Executive Vice President
604-687-4777 or Toll Free: 866-368-7330
604-687-4770 (FAX)
iCAD (ICAD) Reports Significantly Improved Medicare Payment for Intraoperative Radiation Therapy
iCAD, Inc. (Nasdaq: ICAD), a leading provider of advanced imaging and radiation therapy for the early identification and treatment of cancer, today announced the U.S. Centers for Medicare & Medicaid Services (CMS) has issued an improved payment policy for Intraoperative Radiation Therapy (IORT), which is delivered by the Company’s Xoft® Axxent® Electronic Brachytherapy System®. In the 2013 Final Rule issued November 1, 2012, CMS unpackaged the IORT payment codes and assigned a distinct payment value for IORT treatment delivery. CMS assigned IORT treatment delivery to the same ambulatory payment classification as Stereotactic Radiosurgery, MRgFUS and MEG, Level 1.
The payment value for IORT treatment delivery in the Final Rule is more than twice the value included in the Proposed Rule released by CMS in July 2012. The 2013 Final Rule payment codes will take effect on January 1, 2013.
“The decision by CMS to unpackage IORT payments and increase reimbursement rates underscores the cost-effectiveness of this potentially life-saving radiation therapy option that can dramatically reduce treatment times, while providing more convenient and aesthetically desirable outcomes for women with early-stage breast cancer,” said Ken Ferry, President and CEO of iCAD. “We believe this ruling will provide greater access to IORT and accelerate the growing adoption of our technology by radiation oncologists and breast surgeons nationwide. It is noteworthy that IORT reimbursement was substantially improved in light of the overall streamlining of payments for radiation oncology services.”
About the Xoft System
iCAD’s Xoft System delivers IORT for breast cancer in a single, prescribed, targeted dose of isotope-free radiation directly to the tumor cavity during surgery. This minimizes radiation to healthy tissue and organs and eliminates the need for a shielded treatment environment. Typical radiation therapy methods for breast cancer include whole breast radiation, which involves daily treatments for five to seven weeks, and partial breast irradiation where 10 treatments are delivered over a period of five days.
The Xoft System is FDA-cleared for the treatment of early-stage breast cancer, endometrial cancer, skin cancer and for the treatment of other cancers or conditions where radiation therapy is indicated.
Xoft, Inc. is a wholly owned subsidiary of iCAD, Inc. For more information about Xoft visit www.xoftinc.com.
About iCAD, Inc.
iCAD is an industry-leading provider of Computer-Aided Detection (CAD) technologies, advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of common cancers. iCAD offers a comprehensive range of high-performance, upgradeable CAD solutions for mammography and advanced image analysis and workflow solutions for Magnetic Resonance Imaging, for breast and prostate cancers and Computed Tomography for colorectal cancer. iCAD’s Xoft System, offers radiation treatment for early-stage breast cancer that can be administered in the form of intraoperative radiation therapy or accelerated partial breast irradiation. The Xoft System is also cleared for the treatment of non-melanoma skin cancer and endometrial cancer. For more information call (877) iCADnow or visit www.icadmed.com.
“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995:
Certain statements contained in this News Release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve a number of known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, but are not limited to, the Company’s ability to defend itself in litigation matters, the risks relating to the Company’s acquisition of Xoft including, the expected benefits of the acquisition may not be achieved in a timely manner, or at all; the Xoft business operations may not be successfully integrated with iCAD’s and iCAD may be unable to achieve the expected synergies, business and strategic objectives following the transaction, the risks of uncertainty of patent protection; the impact of supply and manufacturing constraints or difficulties; product market acceptance; possible technological obsolescence; increased competition; customer concentration; and other risks detailed in the Company’s filings with the Securities and Exchange Commission. The words “believe”, “demonstrate”, “intend”, “expect”, “estimate”, “anticipate”, “likely”, and similar expressions identify forward-looking statements. Readers are cautioned not to place undue reliance on those forward-looking statements, which speak only as of the date the statement was made. The Company is under no obligation to provide any updates to any information contained in this release. For additional disclosure regarding these and other risks faced by iCAD, please see the disclosure contained in our public filings with the Securities and Exchange Commission, available on the Investors section of our website at http://www.icadmed.com and on the SEC’s website at http://www.sec.gov.
Primo Water (PRMW) and Cuisinart Sign Agreement
WINSTON-SALEM, N.C., Nov. 5, 2012 (GLOBE NEWSWIRE) — Primo Water Corporation (Nasdaq:PRMW), a leading provider of multi-gallon purified bottled water and related products, and Cuisinart, a dominant force in the kitchen electrics and cookware industries, announced today that the companies have signed a three-year sales, distribution and licensing agreement. Under the terms of the agreement, Cuisinart will market and sell Primo Water’s existing line of sparkling beverage appliances and related consumables in North America, and Primo will supply CO2 cylinders for Cuisinart’s new proprietary line of sparkling beverage makers.
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Primo Water’s beverage maker line consists of the Flavorstation and Liberty models, both of which fall under the marketing and sales terms of the new agreement. Beginning this month, Cuisinart will debut its own sparkling beverage makers, which will be powered by Primo Water CO2 cylinders and available in Cuisinart’s traditional retail channels, which encompass department and specialty stores (including online segments). Additionally, Primo Water will provide the distribution and refilling of CO2 cylinders for both its own units and Cuisinart branded sparkling beverage makers.
“This strategic alliance is consistent with our decision to re-focus on our core businesses and strengths, and we are excited to partner with Cuisinart, a leader in kitchen appliances, cookware and other housewares markets,” said Billy Prim, Chairman and CEO of Primo Water. “Cuisinart has the experience and proficiency to grow and maintain sales in this quickly expanding category. Primo has experience and expertise in managing a retail distribution network and can support the growth of this new category by supplying the appliances’ key consumable component – the CO2 cylinder.”
“Cuisinart has been successfully building on its diverse product assortment and strong retail presence, and the beverage maker segment was a natural next step for the company,” said Ron Diamond, President of Conair Corporation, Cuisinart’s parent company. “There are many significant reasons that led us to partner with Primo Water in this endeavor, one of the most important being its direct-store-delivery network to major retailers. This offers a clear advantage over other forms of distribution for CO2 cylinders.”
The Primo Water/Cuisinart partnership was reached at a time when the sparkling beverage maker category is expanding, and offers a significant growth opportunity for both companies. As consumer demand increases, both Primo Water and Cuisinart will be poised to provide a wide range of innovative home beverage-making options for a variety of household needs.
About Cuisinart:
Cuisinart, universally known for introducing the food processor in America, is a leader in culinary appliances, professional quality cookware and kitchen accessories. The company’s cutting edge reputation can be seen on numerous fronts, from industry-first products and design awards to sponsorships of culinary events and TV cooking shows. Cuisinart manufactures a full range of products under the tagline, “Savor the Good Life®.” These products include cookware, countertop cooking appliances, blenders, stand mixers and coffeemakers, as well as food processors, toasters and toaster ovens, ice cream makers, kitchen gadgets and flatware. Cuisinart has the following websites: www.cuisinart.com, www.cuisinart.com/baby and www.cuisinartcleanwater.com, and social media sites: www.facebook.com/cuisinart, www.twitter.com/cuisinart and www.twitter.com/cuisinartpr. The company also has a new iPhone, iPad and Android app, Cuisinart’s KitchenSync http://www.cuisinart.com/recipes/kitchensync.html.
The Cuisinart logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=15558
About Primo Water Corporation:
Primo Water Corporation is a leading provider of multi-gallon purified bottled water, self-serve filtered drinking water, water dispensers and CO2 cylinders sold through major retailers throughout the United States and Canada. Primo’s purified water and appliances can be found at over 20,000 retailers across North America including, Walmart (NYSE:WMT), Lowes Home Improvement (NYSE:LHI), Kmart (Nasdaq:SHLD), Kroger (NYSE:KO), H.E. Butt and many others. Learn more about Primo Water at www.primowater.com
The Primo Water Corporation logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=11942
Forward-Looking Statements
Certain statements contained herein are not based on historical fact and are “forward-looking statements” within the meaning of the applicable securities laws and regulations. Generally, these statements can be identified by the use of words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “feel,” “forecast,” “intend,” “may,” “plan,” “potential,” “project,” “should,” “would,” “will,” and similar expressions intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Owing to the uncertainties inherent in forward-looking statements, actual results could differ materially from those stated here. Factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, the failure of Primo Water’s new agreement with Conair Corporation (described in this news release) to generate anticipated sales, earnings or other benefits, the loss of major retail customers of Primo Water or the reduction in volume or change in timing of purchases by major retail customers, lower than anticipated consumer and retailer acceptance of Primo Water’s products and services, changes in Primo Water’s relationships with its independent bottlers, distributors and suppliers, the entry of a competitor with greater resources into the marketplace and competition and other business conditions in the water and water dispenser industry in general, Primo Water’s experiencing product liability, or sales returns associated with a product quality or safety issue, the loss of key Primo Water personnel, changes in the regulatory framework governing Primo Water’s business, Primo Water’s inability to efficiently and effectively integrate acquired businesses with its historical businesses, Primo Water’s inability to efficiently expand operations and capacity to meet growth, Primo Water’s inability to develop, introduce and produce new product offerings (including the Flavorstation line of appliances) within the anticipated timeframe or at all, as well as other risks described more fully in Primo Water’s Annual Report on Form 10-K filed with the Securities and Exchange Commission and its subsequent filings under the Securities Exchange Act of 1934. Forward-looking statements reflect management’s analysis as of the date of this press release. Primo Water does not undertake to revise these statements to reflect subsequent developments, except as required by applicable law.
CONTACT: Mary M. Rodgers Cuisinart Phone: (203) 975-4609 E-mail: mary_rodgers@conair.com or Mark Castaneda Primo Water Corp. Phone: (336) 331-4047 E-mail: mcastaneda@primowater.com
MEI Pharma (MEIP) Announces $27.5 Million Private Placement
Financing Led by New Institutional Investors Vivo Ventures and New Leaf Venture Partners
SAN DIEGO, Nov. 5, 2012 /PRNewswire/ — MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, announced today that it has obtained commitments to purchase $27.5 million of its common stock and warrants in a private placement.
(Logo: http://photos.prnewswire.com/prnh/20120628/LA32362LOGO)
The financing was led by new investors Vivo Ventures and New Leaf Venture Partners with participation from additional institutional investors, including RA Capital Management and Three Arch Opportunity Fund, among others.
“We and Vivo Ventures are excited to have had the opportunity to build a high-quality syndicate of long-term investors that allows MEI Pharma to aggressively pursue development of Pracinostat,” said Srini Akkaraju, M.D., Ph.D., Managing Director at New Leaf Venture Partners. “We are particularly encouraged by Pracinostat’s evidence of clinical activity in hematologic malignancies with large unmet medical needs, such as myelodysplastic syndrome and acute myeloid leukemia.”
“We believe that Pracinostat has the potential to become a best-in-class compound and that MEI Pharma’s management team is equipped with the drug development expertise to secure marketing approval and realize its significant market potential,” said Albert Cha, M.D., Ph.D., Managing Partner at Vivo Ventures.
MEI Pharma has entered into a securities purchase agreement with the investors pursuant to which the Company will sell units consisting of an aggregate of 55,000,000 shares of its common stock and warrants to purchase up to 38,500,000 additional shares of common stock. Each unit, consisting of one share of common stock and a warrant to purchase 0.7 of a share of common stock, will be sold for a purchase price of $0.50. The warrants will be exercisable at $0.52 per share. Upon closing of the transaction, the warrants will be immediately exercisable and will expire five years from the date of issuance.
MEI Pharma intends to use the net proceeds from the private placement primarily to advance the clinical development of Pracinostat, an oral histone deacetylase (HDAC) inhibitor acquired by the Company in August 2012, and its isoflavone-based drug candidates.
“We are very pleased with the success of this capital raise and the expression of confidence from high-quality healthcare investors such as Vivo Ventures and New Leaf Venture Partners,” said Daniel P. Gold, Ph.D., President and Chief Executive Officer of MEI Pharma. “We believe that this financing will enable us to execute the optimal clinical development and marketing approval strategy for Pracinostat, as well as continue the development of our earlier stage drug candidates.”
Stifel Nicolaus Weisel acted as the sole placement agent for the offering. ROTH Capital Partners and Trout Capital served as advisors to the Company.
The private placement is subject to customary closing conditions and is expected to close in December 2012.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities of MEI Pharma, Inc. nor shall there be any sale of securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
The units, shares and warrants offered in the private placement and the shares issuable upon the exercise of the warrants have not been registered under the Securities Act of 1933, as amended, or state securities laws, and may not be offered or sold in the United States without being registered with the Securities and Exchange Commission (SEC) or through an applicable exemption from SEC registration requirements. The units, shares of common stock and warrants were offered only to accredited investors. The Company has agreed to file a registration statement with the SEC covering the common stock purchased by the investors, as well as the common stock issuable upon exercise of the warrants. Any offering of the Company’s securities under the resale registration statement will be made only by means of a prospectus.
About MEI Pharma
MEI Pharma, Inc. (Nasdaq: MEIP) is a San Diego-based oncology company focused on the clinical development of novel therapies for cancer. The Company’s clinical development pipeline includes lead drug candidate Pracinostat, a potential best-in-class, oral histone deacetylase (HDAC) inhibitor. Pracinostat has been tested in more than 150 patients in multiple Phase I and exploratory Phase II clinical trials, including advanced hematologic malignancies such as myelodysplastic syndrome, acute myeloid leukemia and myelofibrosis. The Company expects to initiate a randomized Phase II trial of Pracinostat in combination with standard-of-care in at least one hematologic malignancy toward the middle of 2013. In addition, MEI Pharma is developing two drug candidates derived from its isoflavone-based technology platform, ME-143 and ME-344. Results from a Phase I trial of intravenous ME-143 in heavily treated patients with solid refractory tumors were presented at the American Society of Clinical Oncology Annual Meeting in June 2012. A Phase I clinical trial of intravenous ME-344 in patients with solid refractory tumors is ongoing. For more information, go to www.meipharma.com.
Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical trials and approved by the FDA as being safe and effective for the intended use. Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management’s current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval, or the failure to obtain such approval, of our product candidates; uncertainties or differences in interpretation in clinical trial results; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.
Hastings (HAST) to Host Midnight Release Parties for The Amazing Spider-man
AMARILLO, Texas, Nov. 2, 2012 /PRNewswire/ — Hastings Entertainment, Inc. (NASDAQ: HAST), a leading multimedia entertainment superstore retailer, has announced its plans to host midnight release parties for The Amazing Spider-man. Fans are encouraged to visit their local Hastings for a midnight release party on Thursday, November 8, 2012. Festivities for the night will begin at 9:00 P.M. local time and will end after the release of the movie at midnight. The midnight release party will be in select stores so check with your local store to see if they are participating.
Fans enjoying the party and awaiting the release of the movie will be able to take advantage of special promotions during the release party. These offers will include: Buy 2 get 3rd free on all magazines and bagged and boarded comics, 30% off used music CD’s, books, video games and video game accessories, and 25% off all action figures. We will also have 2 for $12 on music CDs regularly priced $6.99, any soundtrack priced at $18.99 or less for just $9.99 and many more offers. Make sure to reserve your copy of The Amazing Spider-man early and you could save even more!
To find out more about The Amazing Spider-man midnight release party in your area, visit or contact your local Hastings superstore or visit us online at www.goHastings.com.
About Hastings
Founded in 1968, Hastings Entertainment, Inc. is a leading multimedia entertainment retailer that combines the sale of new and used books, videos, video games and CDs, as well as trends and consumer electronics merchandise, with the rental of videos and video games in a superstore format. We currently operate 137 superstores, averaging approximately 24,000 square feet, primarily in medium-sized markets throughout the United States. We also operate three concept stores, Sun Adventure Sports, located in Amarillo, Texas and Lubbock, Texas, and TRADESMART, located in Littleton, Colorado.
We also operate www.goHastings.com, an e-commerce Internet Web site that makes available to our customers new and used entertainment products and unique, contemporary gifts and toys. The site features exceptional product and pricing offers. The Investor Relations section of our web site contains press releases, a link to request financial information and other literature, and access to our filings with the Securities and Exchange Commission.
Perceptron (PRCP) Announces Conference Call/Webcast for First Quarter Results
PLYMOUTH, MI — (Marketwire) — 11/02/12 — Perceptron, Inc. (NASDAQ: PRCP) will hold its first quarter earnings conference call/webcast chaired by Harry T. Rittenour, President and Chief Executive Officer, on Thursday, November 8, 2012 at 10:00 AM (EST).
Call-in numbers and webcast information for the call are provided below.
Webcast
http://www.visualwebcaster.com/event.asp?id=90672
Conference Call
888 364-3109 (domestic callers) or
719 325-2420 (international callers)
Conference ID
5853545
If you are unable to participate during the live webcast, the call will be digitally rebroadcast for seven days, beginning at 2:00 PM (EST) on Thursday, November 8, 2012.
Rebroadcast
888 203-1112 (domestic callers) or
719 457-0820 (international callers)
Passcode 5853545
A replay of the call will also be available on the Company’s website at www.perceptron.com for approximately one year following the call.
About Perceptron:
Perceptron develops, produces, and sells non-contact measurement and inspection solutions for industrial and commercial applications. The Company’s IBU Products provide solutions for manufacturing process control as well as sensor and software technologies for non-contact measurement, scanning, and inspection applications. Automotive and manufacturing companies throughout the world rely on Perceptron’s metrology solutions to help them manage their complex manufacturing processes to improve quality, shorten product launch times and reduce overall manufacturing costs. IBU also offers Value Added Services such as training and customer support services. Perceptron’s CBU develops and manufactures a variety of handheld visual inspection devices and add-on accessories that are sold to and marketed through strategic partners. Headquartered in Plymouth, Michigan, Perceptron has approximately 230 employees worldwide, with operations in the United States, Germany, France, Spain, Brazil, Japan, Singapore, China and India. For more information, please visit www.perceptron.com.
Contact:
Jack Lowry
Vice President, Finance & CFO
GenVec (GNVC) To Release Third Quarter 2012 Financial Results
GAITHERSBURG, Md., Nov. 2, 2012 /PRNewswire/ — GenVec, Inc. (Nasdaq: GNVC) will report financial results for the third quarter ended September 30, 2012 on Friday, November 9, 2012, before the U.S. financial markets open. The announcement will be followed by a webcast and conference call at 10:00 a.m. EST to discuss the Company’s third quarter financial results and business outlook.
To listen to the live conference call, please dial 877-558-0567 (U.S. or Canada) or 706-643-4980 (international) and use the following Conference ID: 47688439. An audio replay of the conference call will be available starting at 1:00 p.m. EST on November 9, 2012 through November 16, 2012. To listen to the audio replay, dial 855-859-2056 or 404-537-3406 and use Conference Replay ID: 47688439.
To access the webcast or the replay, go to www.genvec.com, click on “Investors and Media,” and click on “Events and Presentations.”
About GenVec
GenVec is a biopharmaceutical company using differentiated, proprietary technologies to create superior therapeutics and vaccines. A key component of our strategy is to develop and commercialize our product candidates through collaborations. GenVec is working with leading companies and organizations such as Novartis, Merial, and the U.S. Government to support a portfolio of product programs that address the prevention and treatment of a number of significant human and animal health concerns. GenVec’s development programs address therapeutic areas such as hearing loss and balance disorders; as well as vaccines against infectious diseases including respiratory syncytial virus (RSV), herpes simplex virus (HSV), dengue fever, malaria, and human immunodeficiency virus (HIV). In the area of animal health, we are developing vaccines against foot-and-mouth disease (FMD). Additional information about GenVec is available at www.genvec.com and in the Company’s various filings with the Securities and Exchange Commission.
Retail Investor and Media Contact: |
Institutional Investor Contact: |
GenVec, Inc. |
S.A. Noonan Communications |
Douglas J. Swirsky |
Susan A. Noonan |
(240) 632-5510 |
(212) 966-3650 |
dswirsky@genvec.com |
susan@sanoonan.com |
Trunkbow (TBOW) Announces Receipt of “Going Private” Proposal
BEIJING, Nov. 2, 2012 /PRNewswire/ — Trunkbow International Holdings Limited (NASDAQ: TBOW) (“Trunkbow” or the “Company”), a leading provider of Mobile Payment Solutions (“MPS”) and Mobile Value Added Services (“MVAS”) in the PRC, today announced that its board of directors has received a preliminary non-binding proposal letter, dated November 2, 2012, from Hou Wanchun, Chairman of the board of directors of the Company, and Li Qiang, Chief Executive Officer and a director of the Company (together, the “Consortium Members“), that proposes a “going-private” transaction involving the acquisition of all of the outstanding shares of the Company’s common stock (the “Shares“) not beneficially owned by the Consortium Members at a price of US$1.46 per Share in cash (the “Acquisition“).
According to the proposal letter, the Acquisition is intended to be financed with a combination of debt and equity capital. A copy of the proposal letter is attached hereto as Exhibit A.
The Company’s board of directors has formed a special committee of independent directors (the “Special Committee“) consisting of Dr. Tan Kokhui, Dr. Lv Tingjie, and Mr. Huang Zhaoxing to consider the Acquisition. The Special Committee intends to retain financial, legal and other advisors to assist it in its review of the Acquisition.
The Company cautions its shareholders and others considering trading in its securities that the board of directors has just received the non-binding proposal from the Consortium Members and no decisions have been made with respect to the Company’s response to the proposal. There can be no assurance that any definitive offer will be made, that any agreement will be executed or that this or any other transaction will be approved or consummated. The Company does not undertake any obligation to provide any updates with respect to the Acquisition or any other transaction, except as required under applicable law.
About Trunkbow International Holding Limited
Trunkbow International Holdings (NASDAQ: TBOW) is a leading provider of Mobile Payment Solutions (“MPS”) and Mobile Value Added Solutions (“MVAS”) in PRC. Trunkbow’s solutions enable the telecom operators to offer their subscribers access to unique mobile applications, innovative tools, value-added services that create a superior mobile experience, and as a result generate higher average revenue per user and reduce subscriber churn. Since its inception in 2001, Trunkbow has established a proven track record of innovation, and has developed a significant market presence in both the Mobile Value Added and Mobile Payment solutions markets. Trunkbow supplies its mobile payment solutions to all three Chinese mobile telecom operators, as well as re-sellers, in several provinces of China. For more information, please visit www.trunkbow.com.
Safe Harbor Statement
This press release contains forward-looking statements that reflect the Company’s current expectations and views of future events that involve known and unknown risks, uncertainties and other factors that may cause its actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such forward looking statements involve known and unknown risks and uncertainties, including but not limited to uncertainties relating to the Company’s relationship with China’s major telecom carriers and its resellers, competition from domestic and international companies, changes in technology, contributions from revenue sharing plans and general economic conditions. The Company has based these forward-looking statements largely on its current expectations and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. You should understand that the Company’s actual future results may be materially different from and worse than what the Company expects. Information regarding these risks, uncertainties and other factors is included in the Company’s annual report on Form 10-K and other filings with the SEC.
Contact Information |
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In China: |
In the U.S. |
Trunkbow International Holdings Limited |
The Piacente Group |
Ms Alice Ye, Chief Financial Officer |
Brandi Floberg/Lee Roth |
Phone: +86 (10) 8571-2518 (Beijing) |
Phone: + (1) 212-481-2050 (New York) |
Email: ir@trunkbow.com |
E-mail: trunkbow@tpg-ir.com |
Exhibit A
November 2, 2012
The Board of Directors
Trunkbow International Holdings Ltd.
Unit 1217-1218, 12F of Tower B, Gemdale Plaza
No. 91 Jianguo Road Chaoyang District, Beijing
People’s Republic of China
Dear Sirs:
We, Hou Wanchun, Chairman of the board of directors of Trunkbow International Holdings Ltd. (the “Company“), and Li Qiang, Chief Executive Officer and a director of the Company (collectively, “we“), are pleased to submit this preliminary non-binding proposal to acquire all of the outstanding shares of the Company’s common stock (the “Shares“) not beneficially owned by us at a price of US$1.46 per Share in cash in a going-private transaction (the “Acquisition“).
We believe that our proposal of US$1.46 per Share in cash will provide a very attractive opportunity to the Company’s shareholders. This price represents a premium of approximately 24.8% to the Company’s closing price on November 1, 2012, a premium of approximately 48.6% to the volume-weighted average price during the last 30 trading days, and a premium of approximately 49.5% to the volume-weighted average price during the last 90 trading days.
The terms and conditions upon which we are prepared to pursue the Acquisition are set forth below. We are confident in our ability to consummate an Acquisition as outlined in this letter.
1. Purchase Price. We are prepared to pay for the Shares acquired in the Acquisition at a price of US$1.46 per Share in cash.
2. Financing. We intend to finance the Acquisition with a combination of debt and equity capital. We are in preliminary discussions with third party financing sources, including VStone Investment Management Limited. We are confident that we will secure adequate financing to consummate the Acquisition.
3. Due Diligence. Parties providing financing will require an opportunity to conduct customary due diligence on the Company.
4. Definitive Agreements. We are prepared to negotiate and finalize definitive agreements (the “Definitive Agreements“) in a timely manner.
5. Confidentiality. We will, as required by law, promptly file a Schedule 13D to disclose this letter. However, we are sure you will agree with us that it is in all of our interests to ensure that we proceed in a confidential manner, unless otherwise required by law, until we have executed the Definitive Agreements or terminated our discussions.
6. Process. We believe that the Acquisition will provide superior value to the Company’s shareholders. We recognize of course that the board of directors of the Company will evaluate the Acquisition independently before it can make its determination whether to endorse it. In considering the proposed Acquisition, you should be aware that we are interested only in acquiring the outstanding Shares that we do not already own, and that we do not intend to sell our stake in the Company to a third party.
7. Advisors. We have retained Cleary Gottlieb Steen & Hamilton LLP as our legal advisor in connection with the Acquisition.
8. No Binding Commitment. This letter constitutes only a preliminary indication of our interest, and does not constitute any binding commitment with respect to the Acquisition. Such a commitment will result only from the execution of Definitive Agreements, and then will be upon the terms and conditions as set out in such agreements.
In closing, each of us would like to personally express our commitment to working together to bring this Acquisition to a successful and timely conclusion. Should you have any questions regarding this proposal, please do not hesitate to contact us.
Sincerely,
____________
Hou Wanchun
____________
Li Qiang
Threshold Pharma (THLD) Reports Third Quarter 2012 Financial and Operational Results
SOUTH SAN FRANCISCO, CA — (Marketwire) — 11/02/12 — Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) today reported financial results for the third quarter ended September 30, 2012. Revenue for the third quarter ended September 30, 2012 was $1.8 million. The operating loss for the third quarter ended September 30, 2012 was $4.0 million. The net loss for the third quarter ended September 30, 2012 was $1.0 million, which included the operating loss of $4.0 million and non-cash income of $3.0 million related to the changes in fair value of the Company’s outstanding and exercised warrants and was classified as other income (expense). As of September 30, 2012, Threshold had $65.8 million in cash, cash equivalents and marketable securities, with no debt outstanding.
Threshold recognized revenue of $1.8 million in the third quarter of 2012, related to a $25 million upfront payment and $32.5 million in milestone payments earned during the first quarter of 2012 as part of the global license and co-development agreement for TH-302 with Merck KGaA, Darmstadt, Germany. Subsequent to the third quarter of 2012, Threshold earned an additional $10 million milestone payment. The revenue from the upfront payment and milestone payments earned under the agreement is being amortized over the relevant performance period, rather than being immediately recognized when the upfront payment and milestone is earned or received. To date, the Company has received $45 million in upfront and milestone payments. The remaining $22.5 million in earned milestone payments will be paid during the fourth quarter of 2012. Threshold could also receive an additional $42.5 million in potential milestone payments in the near term.
The net loss for the third quarter of 2012 was $1.0 million compared to a net loss of $4.0 million for the third quarter of 2011. Included in the net loss for the third quarter of 2012 was non-cash income of $3.0 million compared to non-cash income of $3.7 million in the third quarter of 2011. The non-cash income is related to the change in fair value of the Company’s outstanding and exercised warrants and was classified as other income (expense). Operating loss for the third quarter of 2012 was $4.0 million compared to $7.8 million for the third quarter of 2011. Research and development expenses were $4.0 million for the third quarter of 2012, compared to $6.5 million for the third quarter of 2011. The $2.5 million decrease in research and development expenses are primarily related to the $4.8 million reimbursement credit obtained as part of Merck’s 70% share of total TH-302 development funding under the Merck collaboration, partially offset by an increase of $2.5 million in clinical development and employee related expenses.
General and administrative expenses were $1.7 million for the third quarter of 2012 versus $1.3 million for the third quarter of 2011. The $0.4 million increase in general and administrative expenses was due to an increase in employee related expenses. Non-cash stock-based compensation expense included in operating expenses was $0.9 million for the third quarter of 2012 versus $0.3 million for the third quarter of 2011. The increase in stock-based compensation expense is due to the amortization of a greater number of options with a higher fair value.
For the nine months ended September 30, 2012, cash provided by operating activities was $24.9 million. During the quarter ended September 30, 2012, the Company received approximately $1.6 million from the exercise of warrants to purchase approximately 0.9 million shares of common stock. As of September 30, 2012, Threshold had $65.8 million in cash, cash equivalents and marketable securities.
Clinical Development Update
Threshold is evaluating TH-302, its lead hypoxia-targeted drug, in patients with various solid tumors and hematologic malignancies. Threshold has several ongoing clinical trials of TH-302, including the most advanced “406 trial,” a pivotal Phase 3, randomized controlled trial in combination with doxorubicin in patients with metastatic or locally advanced unresectable soft tissue sarcoma. The “404 trial” is a randomized Phase 2 trial investigating two dose levels of TH-302 in combination with gemcitabine versus gemcitabine alone in patients with advanced pancreatic adenocarcinoma. The “407 trial” is a Phase 1 monotherapy trial in patients with advanced leukemias. The “408 trial” is a Phase 1/2 trial exploring TH-302 monotherapy and in combination with bortezomib in patients with multiple myeloma. The “410 trial” is a Phase 1/2 trial in combination with sunitinib in patients with renal cell carcinoma, gastrointestinal stromal tumors or pancreatic neuroendocrine tumors. To date, across all clinical trials, TH-302 has been administered to more than 700 patients with cancer.
Key accomplishments during the quarter were as follows:
- Updated data including the overall survival results from the “404 trial” evaluating TH-302 in patients with first-line advanced pancreatic cancer were presented at the European Society for Medical Oncology (ESMO) 2012 Congress in Vienna, Austria.
- First data from an ongoing dose-escalation Phase 1/2 investigator-sponsored clinical trial evaluating the safety and efficacy of TH-302 in combination with bevacizumab in patients with recurrent glioblastoma were also reported at the ESMO 2012 Congress.
- The U.S. Food and Drug Administration (FDA) reached agreement with the U.S. affiliate of Merck KGaA covering a Special Protocol Assessment (SPA) for a Phase 3 randomized trial of TH-302 in patients with metastatic or locally advanced unresectable pancreatic cancer.
Key Milestones
Threshold currently anticipates the following key near term clinical milestones for TH-302:
- Merck to initiate the planned pivotal Phase 3 randomized study in patients with first-line pancreatic cancer.
- Provide an update in the first half of 2013 on the interim progression free survival futility analysis for the “406 trial”.
About TH-302
TH-302 is a hypoxia-targeted drug designed to be activated under tumor hypoxic conditions, a hallmark of many cancers. Areas of low oxygen levels (hypoxia) are common in many solid tumors due to insufficient blood vessel growth. Similarly, the bone marrow of patients with hematological malignancies has also been shown, in some cases, to be extremely hypoxic.
TH-302 has been investigated in over 700 patients in Phase 1/2 clinical trials to date in a broad spectrum of tumor types, both as a monotherapy and in combination with chemotherapy treatments and other targeted cancer drugs. Threshold has several additional ongoing clinical trials, the most advanced of which is a Phase 3 pivotal study evaluating TH-302 in combination with doxorubicin versus doxorubicin alone in patients with soft tissue sarcoma. In February 2012, Threshold signed a global license and co-development agreement for TH-302 with Merck KGaA, Darmstadt, Germany.
About Threshold Pharmaceuticals
Threshold is a biotechnology company focused on the discovery and development of drugs targeting Tumor Hypoxia, the low oxygen condition found in microenvironments of most solid tumors as well as the bone marrows of some hematologic malignancies. This approach offers broad potential to treat a variety of cancers. By selectively targeting tumor cells, we are building a pipeline of drugs that hold promise to be more effective and less toxic to healthy tissues than conventional anticancer drugs. For additional information, please visit our website (www.thresholdpharm.com).
Forward-Looking Statements
Except for statements of historical fact, the statements in this press release are forward-looking statements, including statements regarding Threshold’s product candidates, anticipated milestones, clinical trials and anticipated results and announcements, potential therapeutic uses and benefits of TH-302 and financial results, estimates, projections and requirements, including anticipated and potential payments from Merck KGaA. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, Threshold’s ability to enroll or complete its anticipated clinical trials, the time and expense required to conduct such clinical trials and analyze data, whether Merck elects to initiate additional trials, issues arising in the regulatory or manufacturing process and the results of such clinical trials (including product safety issues and efficacy results). Further information regarding these and other risks is included under the heading “Risk Factors” in Threshold’s Quarterly Report on Form 10-Q, which has been filed with the Securities Exchange Commission on August 6, 2012 and is available from the SEC’s website (www.sec.gov) and on our website (www.thresholdpharm.com) under the heading “Investors.” We undertake no duty to update any forward-looking statement made in this news release.
THRESHOLD PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) (Unaudited) Three Months Ended Nine Months Ended September 30, September 30, ------------------ ------------------ 2012 2011 2012 2011 -------- -------- -------- -------- Revenue $ 1,797 $ - $ 3,846 $ - Operating expenses Research and development 4,039 6,481 12,623 17,646 General and administrative 1,741 1,308 5,229 4,290 -------- -------- -------- -------- Total Operating Expenses 5,780 7,789 17,852 21,936 -------- -------- -------- -------- Loss from operations (3,983) (7,789) (14,006) (21,936) Interest income (expense), net 25 6 55 21 Other income (expense) (1) 2,967 3,658 (85,572) 1,537 -------- -------- -------- -------- Net loss $ (991) $ (4,125) $(99,523) $(20,378) ======== ======== ======== ======== Net loss per common share Basic $ (0.02) $ (0.08) $ (1.86) $ (0.45) ======== ======== ======== ======== Diluted $ (0.06) $ (0.08) $ (1.86) $ (0.45) ======== ======== ======== ======== Weighted-average shares used in per common share calculation: Basic 55,654 49,052 53,516 44,812 ======== ======== ======== ======== Diluted 64,405 49,052 53,516 44,812 ======== ======== ======== ======== (1) Noncash income (expense) related to change in the fair value of the Company's outstanding and exercised warrants, classified as other income (expense). THRESHOLD PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) September 30, December 31, 2012 2011 ------------ ------------ (unaudited) (1) Assets Cash, cash equivalents and marketable securities $ 65,825 $ 20,290 Collaboration Receivable 17,457 - Prepaid expenses and other current assets 1,149 254 Property and equipment, net 728 543 Other assets 1,059 1,349 ------------ ------------ Total assets $ 86,218 $ 22,436 ============ ============ Liabilities and stockholders' equity Total current liabilities (2) $ 16,189 $ 8,591 Deferred Revenue 46,467 - Long-term liabilities (3) 67,646 9,362 Stockholders' equity (net capital deficiency) (44,084) 4,483 ------------ ------------ Total liabilities and stockholders' equity $ 86,218 $ 22,436 ============ ============ (1) Derived from audited financial statements (2) Amount includes current portion of deferred revenue of $7.2M as of September 30, 2012 (3) Includes as of September 30, 2012 and December 31, 2011, $67.4 million and $9.2 million of warrant liability, respectively.
Contact
Laura Hansen, Ph.D.
Senior Director, Corporate Communications
Phone: 650-474-8206
Dendreon (DNDN) Announces Third Quarter 2012 Results
November 2, 2012 – Dendreon Corporation (Nasdaq: DNDN) today reported results for the quarter ended September 30, 2012. Net product revenue for the quarter was $78 million, compared to $61 million for the quarter ended September 30, 2011, up 27% year over year and down 2.5% on a sequential basis.
Net loss in the third quarter of 2012 was $154.9 million, or $1.04 per share, compared to a net loss of $147.1 million, or $1.00 per share, for the same period in 2011. The current period includes a one-time charge of approximately $81 million related to cash and non-cash restructuring expenses. Excluding these expenses and other non-cash charges, the Company had a non-GAAP loss of approximately $50 million, or $0.33 per share.
As of September 30, 2012, Dendreon had approximately $445.1 million in cash, cash equivalents, and short-term and long-term investments, compared to $617.7 million as of December 31, 2011.
Recent Highlights:
- Delivered solid performance in community accounts:
- Community urology grew 14% overall quarter over quarter; accounts serviced by the new key account management team put in place earlier this year grew 16%, demonstrating that commercial investments made earlier in the year are paying off
- Performance in community oncology was essentially flat (a decrease of less than 1%), representing an improvement over the 8% decline in the second quarter
- Performance in academic medical centers declined 25%, which we believe is largely driven by an increase in clinical trial activity and site activation by other companies
- Continued new physician interest in PROVENGE® (sipuleucel-T):
- Added 54 net new accounts in the third quarter, bringing total number of infusing accounts to 741
- Continued improvement in reimbursement landscape for physicians:
- Aetna enhanced its coverage policy for PROVENGE prescribers
- Received contract award from the Department of Veterans Affairs
- Reported average time to payment remains less than 30 days for physicians
- Implemented direct-to-consumer initiatives:
- Continued PROPEL education series, with physicians presenting an overview of PROVENGE to patients at local and regional prostate cancer support group meetings
- During Prostate Cancer Awareness Month, executed national media campaign to raise awareness in disparity of prostate cancer in African American men and hosted community events to disseminate PROVENGE information to patients, families and caregivers
- Restructuring is on track:
- Expense reductions are as expected, which bring administrative functions in line with companies of comparable size and complexity
- Expect to begin to see net benefits associated with the restructuring initiatives to begin to appear in financial results as early as the first half of 2013, with full benefits realized in the third quarter of 2013
- Expect to continue to reduce cost of goods sold (COGS) and anticipate seeing COGS below 50% following the closure of the Morris Plains, NJ facility, which is scheduled to close by the end of 2012
- Expect to begin generating positive cash-flow from US operations at $100 million in quarterly sales
- Continued focus on clinical data:
- Data presented at European Society for Medical Oncology’s (ESMO) annual congress continues to provide important insights into the treatment of advanced prostate cancer with PROVENGE
- Actively evaluating partnering strategies for European expansion; completed first patient’s treatment in the sipuleucel-T European Union open-label study; expect a mid-2013 regulatory decision in Europe
- Completed enrollment of Zytiga (abiraterone acetate) sequencing study; expect to present data in 2013
- Made decision to proceed with Xtandi (enzalutamide) sequencing study
“We delivered strong growth in urology and have continued to improve results in oncology, which demonstrate our commercial progress,” said John H. Johnson, chairman, president and chief executive officer. “These results were offset by a decline in the academic setting, which we believe is being driven by an increase in clinical trial activity from other companies. That said, we are pleased with the progress we’ve made in strengthening our commercial organization.”
“With our restructuring on track, we believe we are in a strong financial position and are looking to the future as we meet the growing interest for PROVENGE in the marketplace,” concluded Mr. Johnson.
Conference Call Information
Dendreon will host a conference call on November 2, 2012 at 9:00 a.m. ET. To access the live call, dial 1-877-548-9590 (domestic) or +1-720-545-0037 (international); the conference ID number is 38408702. The call will also be audio webcast with supplemental information slides available from the Company’s website at http://www.dendreon.com under the “Investor/Webcasts and Presentations” section. A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1- 800-585-8367 or +1-404-537-3406 for international callers; the conference ID number is 38408702. The replay will be available from 12:00 p.m. ET on Friday, November 2, 2012 until 11:59 p.m. ET on Thursday, November 8, 2012. In addition, the webcast will be archived for on-demand listening for 90 days at www.dendreon.com and the supplemental information slides will be posted to the Company’s website.
PROVENGE Indication and Important Safety Information
PROVENGE (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.
The safety evaluation of PROVENGE was based on 601 prostate cancer patients in four randomized clinical trials who underwent at least one leukapheresis. The most common adverse events (incidence greater-than or equal to 15%) are chills, fatigue, fever, back pain, nausea, joint ache, and headache. Serious adverse events reported in the PROVENGE group include acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. In controlled clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.
To fulfill a post marketing requirement and as a part of the company’s ongoing commitment to patients, Dendreon will conduct a registry of approximately 1500 patients to further evaluate a small potential safety signal of cerebrovascular events. In four randomized clinical trials of PROVENGE in prostate cancer patients, cerebrovascular events were observed in 3.5% of patients in the PROVENGE group compared with 2.6% of patients in the control group.
For more information on PROVENGE, please see the full prescribing information at http://www.provenge.com or call 1-877-336-3736.
About Dendreon
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development, commercialization and manufacturing of novel therapeutics. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy (ACI) product candidates designed to stimulate an immune response in a variety of tumor types. Dendreon’s first product, PROVENGE® (sipuleucel-T), was approved by the U.S. Food and Drug Administration (FDA) in April 2010. Dendreon is exploring the application of additional ACI product candidates and small molecules for the potential treatment of a variety of cancers. The Company is headquartered in Seattle, Washington, and is traded on the NASDAQ Global Market under the symbol DNDN. For more information about the Company and its programs, visit http://www.dendreon.com/.
Statements in this press release that are not strictly historical in nature constitute “forward-looking statements.” Such statements include, but are not limited to, statements regarding the expected benefits of the restructuring, the timing and elements of the restructuring, the timing and form of related charges, the expected annual operating expense reduction, expectations and beliefs regarding Dendreon’s profitability and Dendreon’s ability to achieve improved performance as a result of the restructuring, expectations regarding regulatory approval of PROVENGE in Europe, expectations regarding the presentation of clinical data, developments affecting Dendreon’s business and prospects and potential revenue and earnings from product sales, and progress generally on commercialization efforts for PROVENGE. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause Dendreon’s actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, our inability to achieve and sustain commercial success for PROVENGE; the identification of efficacy, safety or other issues with PROVENGE; a slower than anticipated adoption by treating physicians of PROVENGE for the treatment of patients with advanced prostate cancer due to competing therapies, perceived difficulties in the treatment process, delays in obtaining reimbursement or for other reasons; any promotional limitations imposed by the FDA on our ability to commercialize and market PROVENGE; unexpected difficulties and costs associated with the rapid expansion of our operations to support the commercial launch of PROVENGE; and other factors discussed in the “Risk Factors” section of Dendreon’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2012. All forward-looking statements are qualified in their entirety by this cautionary statement. Dendreon is providing this information as of the date of this release and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.
DENDREON CORPORATION | ||||||||||||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||||||||
(in thousands, except per share amounts) | ||||||||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||||||||
September 30, | September 30, | |||||||||||||||||||||
2012 | 2011 | 2012 | 2011 | |||||||||||||||||||
(unaudited) | (unaudited) | |||||||||||||||||||||
Product revenue, net | $ | 77,942 | $ | 61,409 | $ | 239,878 | $ | 136,549 | ||||||||||||||
Royalty and other revenue | 29 | 2,878 | 159 | 2,919 | ||||||||||||||||||
Total revenue | 77,971 | 64,287 | 240,037 | 139,468 | ||||||||||||||||||
Operating expenses: | ||||||||||||||||||||||
Cost of product revenue | 51,749 | 54,978 | 173,521 | 102,070 | ||||||||||||||||||
Research and development | 18,643 | 20,417 | 55,683 | 56,591 | ||||||||||||||||||
Selling, general and administrative | 68,109 | 84,920 | 243,643 | 285,280 | ||||||||||||||||||
Restructuring, contract termination and asset impairment | 80,994 | 38,482 | 81,969 | 38,482 | ||||||||||||||||||
Total operating expenses | 219,495 | 198,797 | 554,816 | 482,423 | ||||||||||||||||||
Loss from operations | (141,524 | ) | (134,510 | ) | (314,779 | ) | (342,955 | ) | ||||||||||||||
Interest income | 313 | 285 | 1,071 | 1,078 | ||||||||||||||||||
Interest expense | (13,732 | ) | (12,910 | ) | (41,312 | ) | (34,024 | ) | ||||||||||||||
Other income (expense) | 79 | 24 | 105 | (2 | ) | |||||||||||||||||
Net loss | $ | (154,864 | ) | $ | (147,111 | ) | $ | (354,915 | ) | $ | (375,903 | ) | ||||||||||
Basic and diluted net loss per share | $ | (1.04 | ) | $ | (1.00 | ) | $ | (2.39 | ) | $ | (2.58 | ) | ||||||||||
Shares used in computation of basic and diluted net loss per share | 149,593 | 146,426 | 148,455 | 145,953 | ||||||||||||||||||
September 30, | December 31, | |||||||||
2012 | 2011 | |||||||||
Balance Sheet Data: | ||||||||||
Cash and cash equivalents | $ | 226,696 | $ | 427,100 | ||||||
Short-term investments | 163,519 | 111,525 | ||||||||
Long-term investments | 54,854 | 79,071 | ||||||||
Total cash and cash equivalents, short-term investments and long-term investments | 445,069 | 617,696 | ||||||||
Trade accounts receivable | 38,307 | 35,541 | ||||||||
Prepaid antigen costs | 963 | 7,490 | ||||||||
Inventory | 68,594 | 69,502 | ||||||||
Total assets | 742,093 | 1,001,491 | ||||||||
Convertible senior notes due 2016 | 526,477 | 508,418 | ||||||||
Convertible senior subordinated notes due 2014 | 27,685 | 27,685 | ||||||||
Total stockholders’ equity | 57,828 | 352,637 | ||||||||
DENDREON CORPORATION | ||||||||||||||||||||||
RECONCILIATION OF GAAP TO NON-GAAP NET LOSS | ||||||||||||||||||||||
(in thousands, except per share amounts) | ||||||||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||||||||
September 30, | September 30, | |||||||||||||||||||||
2012 | 2011 | 2012 | 2011 | |||||||||||||||||||
(unaudited) | (unaudited) | |||||||||||||||||||||
GAAP net loss | $ | (154,864 | ) | $ | (147,111 | ) | $ | (354,915 | ) | $ | (375,903 | ) | ||||||||||
Non-GAAP adjustments: | ||||||||||||||||||||||
Depreciation and amortization expense | 9,498 | 9,842 | 31,152 | 25,797 | ||||||||||||||||||
Imputed interest related to the convertible senior notes due 2016 | 6,142 | 5,664 | 18,059 | 15,515 | ||||||||||||||||||
Restructuring, contract termination and asset impairment, including stock-based compensation expense: | ||||||||||||||||||||||
Severance, contract termination and other expense | 14,009 | 18,630 | 14,984 | 18,630 | ||||||||||||||||||
Non-cash stock-based compensation expense | 1,690 | 5,022 | 1,690 | 5,022 | ||||||||||||||||||
Non-cash asset impairment | 65,295 | 14,830 | 65,295 | 14,830 | ||||||||||||||||||
Management severance and other termination benefits: | ||||||||||||||||||||||
Severance expense | — | — | 6,965 | — | ||||||||||||||||||
Non-cash stock-based compensation expense | — | — | 15,112 | — | ||||||||||||||||||
Other stock-based compensation expense | 8,194 | 11,684 | 40,462 | 43,114 | ||||||||||||||||||
Non-GAAP net loss | $ | (50,036 | ) | $ | (81,439 | ) | $ | (161,196 | ) | $ | (252,995 | ) | ||||||||||
Non-GAAP net loss per share- basic and diluted | $ | (0.33 | ) | $ | (0.56 | ) | $ | (1.09 | ) | $ | (1.73 | ) | ||||||||||
Shares used in computation of basic and diluted net loss per share | 149,593 | 146,426 | 148,455 | 145,953 | ||||||||||||||||||
The above table provides certain non-GAAP financial measures that include adjustments to GAAP figures. Dendreon believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Dendreon’s financial performance and its prospects for the future. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of operational results and trends. We believe excluding these items provides important insight into our operational results, important for a company at our stage in development. In addition, these non-GAAP financial measures are among the indicators Dendreon management uses for planning and forecasting purposes and measuring the Company’s performance. These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP figures.
Vimicro Subsidiary (VIMC) Receives Major Video-Surveillance Contract
BEIJING, Nov. 1, 2012 /PRNewswire-FirstCall/ — Vimicro International Corporation (NASDAQ: VIMC) (“Vimicro” or the “Company”), a leading PC-camera processor and IP-based surveillance solution provider, today announced that its subsidiary Vimicro Electronics Corporation has secured a major government purchase contract (the “Contract”) from the Jinzhong City Public Security Bureau of Shanxi province to provide Surveillance Video and Audio Coding (SVAC)-based security surveillance products and services (the “Project”).
Vimicro Electronics Corporation, together with local partners, including Jinzhong Broadcast and TV Network Co., Ltd., will develop the Project. Vimicro Electronics Corporation will supply the products and services for the Project, including key video surveillance-related hardware and software. Vimicro Electronics Corporation’s portion of the contract value will be US $6.23 million (RMB 39.49 million), out of a total contract value of US $13.1 million (RMB 82.5 million), which will be shared by all partners. Work on the Project is expected to be completed by the end of February 2013.
“We are pleased to receive this significant contract from a local government entity,” said David Tang, Chief Financial Officer of Vimicro. “The award of this project shows that Vimicro’s surveillance technology is achieving recognition by the market, especially by the important public security sector we are targeting. We look forward to working with our partners to implement a surveillance system centered on our SVAC-based products and services. The success of this implementation should enable Vimicro to secure additional surveillance contracts in the future.”
About Vimicro International Corporation
Vimicro International Corporation is a leading multimedia semiconductor and solution provider that designs, develops and markets mixed-signal semiconductor products and system-level solutions that enable multimedia capabilities in a variety of products for PC/Notebook, consumer electronics and surveillance markets. Vimicro is aggressively expanding business into the surveillance market with system-level solutions and semiconductor products to capitalize on China’s domestic demand. Vimicro’s ADSs, each of which represents four ordinary shares, are currently trading on the NASDAQ Global Market under the ticker symbol “VIMC.”
Forward-Looking Statements
This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “confident” and similar statements. Among other things, the quotations from management in this announcement, as well as Vimicro’s expectations and forecasts, contain forward-looking statements. Vimicro may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission on forms 20-F and 6-K, etc., in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about Vimicro’s beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: the company’s ability to develop and sell new mobile multimedia products; the expected growth of the mobile multimedia market; the company’s ability to increase sales of notebook camera multimedia processors; the company’s ability to retain existing customers and acquire new customers and respond to competitive market conditions; the company’s ability to respond in a timely manner to the evolving multimedia market and changing consumer preferences and industry standards and to stay abreast of technological changes; the company’s ability to secure sufficient foundry capacity in a timely manner; the company’s ability to effectively protect its intellectual property and the risk that it may infringe on the intellectual property of others; and cyclicality of the semiconductor industry. Further information regarding these and other risks is included in Vimicro’s annual report on Form 20-F filed with the Securities and Exchange Commission. Vimicro does not undertake any obligation to update any forward-looking statement, except as required under applicable law. All information provided in this press release is as of the date hereof, and Vimicro undertakes no duty to update such information, except as required under applicable law.
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