Archive for July, 2013
(TTHI) FDA Grants Fast Track to ELND005 for Alzheimer’s
TORONTO, July 17, 2013 /CNW/ – Transition Therapeutics Inc. (“Transition” or the “Company”) (NASDAQ: TTHI, TSX: TTH) announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation to the development program for ELND005 which was submitted for the treatment of Neuropsychiatric Symptoms (NPS) in Alzheimer’s disease (AD). The FDA concluded that the development program for ELND005 for the treatment of NPS in AD meets their criteria for Fast Track Designation.
Transition’s licensing partner, Elan Corporation, plc (“Elan”), is responsible for all development and commercialization activities and costs of ELND005.
About Study AG201
The objectives of Study AG201 are to evaluate the efficacy, safety and tolerability of ELND005 over 12 weeks of treatment in patients with moderate to severe AD, who are experiencing at least moderate levels of agitation/aggression. The study is expected to enroll approximately 400 patients at multiple sites in the US, Canada and other selected regions. In the Phase 2 AD Study (AD201), ELND005 appeared to decrease the emergence and severity of specific NPS, an effect which seemed to correlate with drug exposure for some symptoms. ELND005 also led to a sustained reduction of brain Myo-inositol levels that are thought to play a role in phospho-inositol signaling pathways and synaptic activity. More information on Study ELND005-AG201 is available at http://www.clinicaltrials.gov/.
About Neuropsychiatric Symptoms and Alzheimer’s Disease
It is currently estimated that approximately 5.4 million Americans and approximately 7.2 million Europeans have AD and these numbers are expected to rise to 16 million by 2050. AD is a progressive brain disorder that gradually destroys a person’s memory and ability to learn, reason, make judgements, communicate and carry out daily activities. Approximately 90% of AD patients develop NPS, and up to 60% develop agitation/aggression over the course of their disease. Agitation/aggression are among the most disruptive NPS in AD and are associated with increased morbidity and caregiver burden.
About ELND005
ELND005 is an orally bioavailable small molecule that is being investigated by Transition’s licensing partner, Elan, for multiple neuropsychiatric indications on the basis of its proposed dual mechanism of action, which includes β-amyloid anti-aggregation and regulation of brain myo-inositol levels. An extensive clinical program of Phase 1 and Phase 2 studies have been completed with ELND005 to support clinical development, including the recently published Phase 2 study ELND005-AD201 in AD. ELND005 is also being studied as a maintenance treatment of Bipolar Disease in an ongoing study (Study ELND005-BPD201).
About Fast Track Designation
The fast track programs of the FDA are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs (fast track products). This designation enables more frequent interactions with the FDA during drug development and indicates the NDA may be considered for priority review. In addition, portions of marketing applications for drugs with Fast Track designation can be submitted before a complete application is submitted, known as rolling review.
About Transition
Transition is a biopharmaceutical company, developing novel therapeutics for disease indications with large markets. The Company’s lead CNS drug candidate is ELND005 for the treatment of Alzheimer’s disease and bipolar disorder. Transition’s lead metabolic drug candidate is TT-401 for the treatment of type 2 diabetes and accompanying obesity. The Company’s shares are listed on the NASDAQ under the symbol “TTHI” and the Toronto Stock Exchange under the symbol “TTH”. For additional information about the Company, please visit www.transitiontherapeutics.com.
Notice to Readers: Information contained in our press releases should be considered accurate only as of the date of the release and may be superseded by more recent information we have disclosed in later press releases, filings with the OSC, SEC or otherwise. Except for historical information, this press release may contain forward-looking statements, relating to expectations, plans or prospects for Transition, including conducting clinical trials and potential efficacy of its products. These statements are based upon the current expectations and beliefs of Transition’s management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include factors beyond Transition’s control and the risk factors and other cautionary statements discussed in Transition’s quarterly and annual filings with the Canadian commissions.
SOURCE: Transition Therapeutics Inc.
For further information on Transition, visit www.transitiontherapeutics.com or contact:
Dr. Tony Cruz
Chief Executive Officer
Transition Therapeutics Inc.
Phone: 416-260-7770, x.223
tcruz@transitiontherapeutics.com
(GFED) Announces Preliminary Second Quarter 2013 Financial Results
SPRINGFIELD, Mo., July 15, 2013 (GLOBE NEWSWIRE) — Guaranty Federal Bancshares, Inc., (Nasdaq:GFED), the holding company (the “Company”) for Guaranty Bank, today announces the following results for its second quarter ended June 30, 2013.
Second Quarter 2013 Financial Highlights
- Basic and diluted earnings per common share for the quarter increased to $0.50 and $0.49, respectively, compared to basic and diluted loss per common share of $(0.02) for the same quarter in 2012.
- Net income increased to $1.6 million for the quarter compared to $344,000 for the same quarter in 2012. This is also an increase from the $953,000 earned in the first quarter of 2013.
- Annualized return on average assets increased to .97% for the quarter compared to .21% for the same quarter in 2012.
- Annualized return on average equity increased to 12.33% for the quarter compared to 2.16% for the same quarter in 2012.
- Transaction deposit account balances as of June 30, 2013 increased $25.9 million, or 7%, since December 31, 2012.
- Long-term borrowings (classified as non-core funding liabilities) decreased $30.1 million as of June 30, 2013 compared to December 31, 2012.
Net income for the second quarter ended June 30, 2013 was $1,567,000 as compared to $344,000 for the same quarter in 2012. This is also an increase from the $953,000 earned in the first quarter of 2013. After preferred stock dividends and accretion, diluted earnings per common share was $0.49 for the quarter, an increase from the loss per diluted common share of $(.02) during the same quarter in 2012 and an increase from the $.25 per diluted common share earned in the first quarter of 2013.
The following were key issues that contributed to the second quarter operating results compared to the same quarter in 2012 and the financial condition results compared to December 31, 2012:
Net interest income – Improvement in net interest income and margin continues to be a primary objective for the Company. However, economic conditions, weak loan demand and the prolonged low interest rate environment have made it difficult to increase balances in the loan portfolio. Total net loans have declined $7.4 million since December 31, 2012 and $14.2 million since June 30, 2012 which has had a negative impact on interest income and net interest margin. Despite the decline in loans, net interest income and margin have increased slightly over the prior year quarter due to the Company’s efforts in growing core deposits and reducing non-core liabilities. Also, the Company has benefited from the continued repricing of its deposit products in the latter half of 2012 and into 2013 as well as the interest expense reduction from eliminating $30.1 million of wholesale funding balances (Federal Home Loan Bank advances and repurchase agreements) during the six month period ended June 30, 2013. The average cost of funds for the quarter was .92% compared to 1.24% for the same quarter in 2012.
Non-interest income – Non-interest income increased $1.6 million during the quarter primarily due to the Company’s gains on investments and tax credit assets. In May 2013, the Company sold $3.7 million of investment securities and low-income housing tax credits for a gain of $1.5 million. With those proceeds and available cash, the Company prepaid a $15 million repurchase agreement (bearing annual interest at 2.60%) incurring a prepayment penalty of $1.5 million. The prepayment has allowed the Company to significantly reduce higher cost, non-core funding liabilities on its balance sheet and eliminate future annual interest expense of $390,000.
Non-interest expense – Non-interest expense increased $1.6 million over the prior year quarter primarily due to a $1.5 million prepayment penalty incurred on a structured transaction discussed above. All other non-interest expenses have been closely managed and controlled. Excluding the structured transaction, the Company’s efficiency ratio would have been 63.30% for the quarter, rather than 70.29%, and would have been an improvement over the same quarter in 2012.
Provision for loan loss expense and allowance for loan losses – Based on its reserve analysis and methodology, the Company recorded a provision for loan loss expense of $250,000 during the quarter, a decrease from the $2.1 million recognized in the prior year quarter. The allowance for loan losses as of June 30, 2013 was 1.79% of gross loans outstanding (excluding mortgage loans held for sale) compared to 1.84% as of December 31, 2012.
Capital – At June 30, 2013, as compared to December 31, 2012, stockholders’ equity decreased $2.4 million, with a corresponding reduction in book value per common share of $.95 to $13.39. This is due to a few factors. First, stockholders’ equity increased for the six month period due to $2.1 million in net income after preferred stock dividends and accretion. However, other factors reduced stockholders’ equity. In May 2013, the Company completed a $2 million repurchase of the warrant issued to the United States Department of the Treasury in 2009 as part of its Troubled Asset Relief Program’s Capital Purchase Program. The Treasury no longer has any equity interest in the Company which eliminates any potential shareholder dilution that would have occurred had the warrant been exercised rather than repurchased. Also, as a result of increases in market interest rates on many debt securities during the quarter, the Company’s unrealized gains on available-for-sale securities declined $2.7 million at June 30, 2013 as compared to December 31, 2012. Despite the reduction in stockholders’ equity, the Company and the Bank’s regulatory capital ratios remain strong and well above regulatory requirements.
Non-performing assets – Compared to December 31, 2012, the Company experienced an improvement in nonperforming assets which were $19.7 million as of June 30, 2013. Nonperforming assets as a percentage of total assets was 3.08% as of June 30, 2013 compared to 3.01% as of December 31, 2012. The percentage increase is only due to the Company’s decline in total assets. Reducing non-performing assets has been and will continue to be a primary focus of the Company.
Non-Generally Accepted Accounting Principle (GAAP) Financial Measures
In addition to the GAAP financial results presented in this press release, the Company presents non-GAAP financial measures discussed below. These non-GAAP measures are provided to enhance investors’ overall understanding of the Company’s current financial performance. Additionally, Company management believes that this presentation enables meaningful comparison of financial performance in various periods. However, the non-GAAP financial results presented should not be considered a substitute for results that are presented in a manner consistent with GAAP. A limitation of the non-GAAP financial measures presented is that the adjustments concern gains, losses or expenses that the Company does expect to continue to recognize; the adjustments of these items should not be construed as an inference that these gains or expenses are unusual, infrequent or non-recurring. Therefore, Company management believes that both GAAP measures of its financial performance and the respective non-GAAP measures should be considered together.
Operating Income
Operating income is a non-GAAP financial measure that adjusts net income for the following non-operating items:
- Gains on sales of available-for-sale securities
- Losses on foreclosed assets held for sale
- Gains on sales of Missouri low-income housing tax credits
- Prepayment penalty on repurchase agreements
- Charge for loss on deposit accounts
- Provision for loan loss expense
- Provision (credit) for income taxes
A reconciliation of the Company’s net income to its operating income for the three and six months ended June 30, 2013 and 2012 is set forth below.
Three Months Ended | Six Months Ended | |||
30-Jun-13 | 30-Jun-12 | 30-Jun-13 | 30-Jun-12 | |
(Dollar amounts are in thousands) | ||||
Net income | $ 1,567 | $ 344 | $ 2,520 | $ 1,179 |
Add back: | ||||
Provision (credit) for income taxes | 521 | (192) | 753 | (112) |
Income before income taxes | 2,088 | 152 | 3,273 | 1,067 |
Add back/(subtract): | ||||
Gains on investment securities | (116) | (70) | (205) | (107) |
Loss on foreclosed assets held for sale | 76 | 71 | 148 | 172 |
Gain on sale of low-income housing tax credits | (1,441) | — | (1,441) | — |
Prepayment penalty on repurchase agreements | 1,510 | — | 1,510 | — |
Loss on deposit accounts | — | — | 231 | — |
Provision for loan loss expense | 250 | 2,100 | 650 | 3,000 |
279 | 2,101 | 893 | 3,065 | |
Operating income | $ 2,367 | $ 2,253 | $ 4,166 | $ 4,132 |
About Guaranty Federal Bancshares, Inc.
Guaranty Federal Bancshares, Inc. (Nasdaq:GFED) has a subsidiary corporation offering full banking services. The principal subsidiary, Guaranty Bank, is headquartered in Springfield, Missouri, and has nine full-service branches in Greene and Christian Counties and a Loan Production Office in Webster County. In addition, Guaranty Bank is a member of the TransFund ATM network which provides its customers surcharge free access to over 100 area ATMs and over 1,600 ATMs nationwide. For more information visit the Guaranty Bank website: www.gbankmo.com.
The discussion set forth above may contain forward-looking comments. Such comments are based upon the information currently available to management of the Company and management’s perception thereof as of the date of this release. When used in this release, words such as “anticipates,” “estimates,” “believes,” “expects,” and similar expressions are intended to identify forward-looking statements but are not the exclusive means of identifying such statements. Such statements are subject to risks and uncertainties. Actual results of the Company’s operations could materially differ from those forward-looking comments. The differences could be caused by a number of factors or combination of factors including, but not limited to: changes in demand for banking services; changes in portfolio composition; changes in management strategy; increased competition from both bank and non-bank companies; changes in the general level of interest rates; the effect of regulatory or government legislative changes; technology changes; fluctuation in inflation; and other factors set forth in reports and other documents filed by the Company with the Securities and Exchange Commission from time to time.
Financial Highlights: | ||||
Three Months Ended | Six Months Ended | |||
Operating Data: | 30-Jun-13 | 30-Jun-12 | 30-Jun-13 | 30-Jun-12 |
(Dollar amounts are in thousands, except per share data) | ||||
Total interest income | $ 6,467 | $ 6,846 | $ 12,886 | $ 13,712 |
Total interest expense | 1,281 | 1,732 | 2,709 | 3,582 |
Net interest income | 5,186 | 5,114 | 10,177 | 10,130 |
Provision for loan losses | 250 | 2,100 | 650 | 3,000 |
Net interest income after provision for loan losses | 4,936 | 3,014 | 9,527 | 7,130 |
Noninterest income | 2,684 | 1,040 | 3,704 | 1,887 |
Noninterest expense | 5,532 | 3,902 | 9,958 | 7,950 |
Income before income taxes | 2,088 | 152 | 3,273 | 1,067 |
Provision (credit) for income taxes | 521 | (192) | 753 | (112) |
Net income | $ 1,567 | $ 344 | $ 2,520 | $ 1,179 |
Preferred stock dividends and discount accretion | 198 | 398 | 397 | 679 |
Net income (loss) available to common shareholders | $ 1,369 | $ (54) | $ 2,123 | $ 500 |
Basic income (loss) per common share | $ 0.50 | $ (0.02) | $ 0.78 | $ 0.18 |
Diluted income (loss) per common share | $ 0.49 | $ (0.02) | $ 0.76 | $ 0.17 |
Annualized return on average assets | 0.97% | 0.21% | 0.78% | 0.37% |
Annualized return on average equity | 12.33% | 2.16% | 9.91% | 4.33% |
Net interest margin | 3.42% | 3.39% | 3.37% | 3.38% |
Efficiency ratio | 70.29% | 63.41% | 71.74% | 66.16% |
As of | As of | |||
Financial Condition Data: | 30-Jun-13 | 31-Dec-12 | ||
Cash and cash equivalents | $ 23,855 | $ 41,663 | ||
Investments | 109,349 | 102,162 | ||
Loans, net of allowance for loan losses 6/30/2013 — $8,377; 12/31/2012 — $8,740 | 460,943 | 468,376 | ||
Other assets | 46,050 | 48,231 | ||
Total assets | $ 640,197 | $ 660,432 | ||
Deposits | $ 511,889 | $ 500,015 | ||
FHLB advances | 52,950 | 68,050 | ||
Subordinated debentures | 15,465 | 15,465 | ||
Securities sold under agreements to repurchase | 10,000 | 25,000 | ||
Other liabilities | 1,431 | 1,034 | ||
Total liabilities | 591,735 | 609,564 | ||
Stockholders’ equity | 48,462 | 50,868 | ||
Total liabilities and stockholders’ equity | $ 640,197 | $ 660,432 | ||
Equity to assets ratio | 7.57% | 7.70% | ||
Book value per common share | $ 13.39 | $ 14.34 | ||
Nonperforming assets | $ 19,748 | $ 19,861 |
CONTACT: Shaun A. Burke, President & CEO or Carter M. Peters, CFO 1341 W. Battlefield Springfield, MO 65807 417.520.4333
(FFEX) Enters Into Merger to be Acquired by Duff Brothers for $2.10 Per Share in Cash
DALLAS and COLUMBIA, Miss., July 15, 2013 (GLOBE NEWSWIRE) — Frozen Food Express Industries, Inc. (Nasdaq:FFEX) (“FFE” or the “Company”) and Duff Brothers Capital Corporation today announced they have entered into a definitive agreement pursuant to which Duff Brothers Capital Corporation will offer to acquire all of the outstanding shares of common stock of FFE (except shares owned by its affiliates) for $2.10 in cash per share of common stock. Duff Brothers Capital Corporation is wholly owned by Thomas and James Duff, who also indirectly own KLLM Transport Services, LLC. The transaction, which values FFE at approximately $38.2 million in equity value, was unanimously approved by the FFE Board of Directors.
“For over a year, we have been reviewing a variety of strategic alternatives for FFE, which included exiting less profitable businesses, such as dry van truckload services, entering into the bulk tank water transportation business, and re-engineering our LTL services with technology enhancements that further differentiate our service offerings in the marketplace,” said Russell Stubbs, President and CEO of FFE. “As part of this process, we were pleased when the Duffs expressed an interest in FFE. We believe the value of this transaction achieves our objective of delivering immediate and compelling value for our shareholders. Through the Duff’s ownership of KLLM, they have demonstrated a strong track record in the trucking industry, which will be beneficial to our customers, vendors, employees and drivers.”
On behalf of James and Thomas Duff, Mr. Thomas Duff stated that, “We are excited about the opportunity to add another leader in the temperature controlled trucking industry to our family group of businesses. With the synergies and increased capacity that we can gain from the ownership of both FFE and KLLM, we know that we will be able to enhance the quality service that both companies have been providing to their customers. With our resources, we will be able to bring to FFE the financial strength that is needed to preserve and expand its operations for its valued employees for years to come. Overall, we see great things ahead for both of the companies.”
Under the terms of the merger agreement, FFE’s stockholders will receive $2.10 in cash for each outstanding share of FFE common stock they own, representing a 23.5% premium over the closing price on July 12, 2013, the last full trading day before today’s announcement, a 26.5% premium over the closing price on March 1, 2013, the last full trading day before the announcement that the Duffs had acquired approximately 5.84% of the outstanding shares of common stock of FFE and expressed an intent to discuss with FFE a negotiated acquisition and a 144.2% premium over the closing price on December 18, 2012, the last full trading day before the Duffs began open market purchases of FFE shares with a view towards accumulating a significant position.
The transaction is expected to close by late August or early September 2013.
In accordance with the terms of the merger agreement, Duff Brothers Capital Corporation will commence a tender offer for all of the outstanding shares of common stock of FEE not already owned by the Duffs or their affiliates. FFE’s Board of Directors has unanimously recommended that the FFE shareholders tender their shares into the offer. Under the terms of the agreement, the transaction is conditioned upon satisfaction of the minimum tender condition of greater than two-thirds of the outstanding shares of FFE common stock when added to the shares then beneficially owned by Duff Brothers Capital Corporation and its affiliates and other customary closing conditions. Consummation of the transactions contemplated by the merger agreement is not subject to a financing condition and Duff Brothers Capital Corporation will pay the offer price from cash resources on hand.
Concurrent with the execution and delivery of the merger agreement, Stoney M. Stubbs, Jr., FFE’s Chairman of the Board, Russell Stubbs, FFE’s President and CEO, and John Hickerson, FFE’s Executive Vice President and Chief Operating Officer, representing in the aggregate approximately 12.8% of the outstanding shares of FFE common stock have each entered into separate agreements with Duff Brothers Capital Corporation and Duff Brothers Subsidiary, Inc. pursuant to which each has agreed to tender the shares of common stock beneficially owned by them into the tender offer, as well as providing certain covenants and releases related to the transactions contemplated by the merger agreement.
Stephens Inc. is acting as exclusive financial advisor to the FFE Board of Directors and provided a fairness opinion to the FFE Board of Directors. Baker & McKenzie LLP is acting as legal counsel to the FFE Board of Directors. Krage & Janvey, L.L.P. is acting as legal counsel to Duff Brothers Capital Corporation.
Additional Information and Where to Find It
The tender offer described in the communication has not yet commenced and this communication is neither an offer to purchase nor a solicitation of an offer to sell shares of common stock of Frozen Food Express Industries, Inc. (“FFE”). At the time the tender offer is commenced, Duff Brothers Capital Corporation will file with the SEC a Tender Offer Statement on Schedule TO, and FFE will file a Solicitation/Recommendation Statement on Schedule 14D-9 with respect to the tender offer. FFE stockholders and other investors are strongly advised to read the tender offer materials (including the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents) and the Solicitation/Recommendation Statement, as they may be amended from time to time, because they will contain important information which should be read carefully before any decision is made with respect to the tender offer. The Offer to Purchase, the related Letter of Transmittal and certain other offer documents, as well as the Solicitation/Recommendation Statement, will be made available to all FFE stockholders at no expense to them. The Tender Offer Statement and the Solicitation/Recommendation Statement will also be available for free at the SEC’s website at www.sec.gov. Free copies of these materials and other tender offer documents will also be made available by the information agent for the tender offer.
In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, FFE files annual, quarterly and special reports, proxy statements and other information with the SEC. You may read and copy any reports, statements or other information filed by FFE at the SEC public reference room at 100 F Street, N.E., Washington, D.C. 20549. Please call the Commission at 1-800-SEC-0330 for further information on the public reference room. FFE’s filings with the SEC are also available to the public from commercial document-retrieval services and at the website maintained by the SEC at www.sec.gov.
About FFE
Frozen Food Express Industries, Inc. is one of the leading temperature-controlled truckload and less-than-truckload carriers in the United States with core operations in the transport of temperature-controlled products and perishable goods including food, health care and confectionery products. Service is offered in over-the-road and intermodal modes for temperature-controlled truckload and less-than-truckload, as well as dry truckload on a non-dedicated fleet basis. We also provide bulk tank water transportation, brokerage/logistics and dedicated services to our customers. Additional information about FFE can be found at www.ffeinc.com.
Forward-Looking Statements
This communication contains “forward-looking statements,” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, relating to the acquisition of FFE by Duff Brothers Capital Corporation. All statements relating to plans, strategies, objectives, expectations and intentions, all statements identified by words such as “will”, “could”, “should”, “believe”, “expect”, “intend”, “plan”, “schedule”, “estimate”, “project”, and similar expressions and all statements other than historical facts included in this communication, including, but not limited to, the statements regarding the timing and the closing of the tender offer and merger transactions, the expected benefits of the transaction, any plans to operate FFE post-closing and any assumptions underlying any of the foregoing, are forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown, or unknown risks or uncertainties materialize, actual results could vary materially from expectations and projections. Risks and uncertainties include, among other things, uncertainties as to the timing of the tender offer and merger; uncertainties as to how many of FFE’s stockholders will tender their stock in the tender offer; the possibility that various closing conditions to the tender offer and merger transactions may not be satisfied or waived, including that a governmental entity may prohibit, delay, or refuse to grant approval for the consummation of the transaction; that there is a material adverse change to FFE; any material adverse development in pending or threatened litigation involving FFE; other business effects, including effects of industry, economic or political conditions outside FFE’s control; transaction costs; actual or contingent liabilities; as well as other cautionary statements contained elsewhere herein and in FFE’s periodic reports filed with the SEC including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which apply only as of the date of this communication. FFE expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. Additional information about FFE is available at www.ffeinc.com.
CONTACT: Frozen Food Express Industries, Inc. Russell Stubbs, President and CEO John Hickerson, EVP and COO Steve Stedman, VP and Interim CFO (214) 630-8090
(COGO) Chairman and CEO Proposes Acquiring 30.4% of Cogo Net Assets
– Upon completion of the transaction, Net Asset Value of Cogo shares is expected to be more than $6 a share, compared to the current share price of [1]$2.05 a share. – Such assets represent approximately 30.5% of Cogo’s net assets, generated approximately 98.7% of its revenues and 66.5% of its gross profits as of the first quarter of 2013.
SHENZHEN, China, July 15, 2013 /PRNewswire/ — Cogo Group, Inc. (“Cogo,” or the “Company”) (NASDAQ: COGO), a leading gateway for global semiconductor companies to access the industrial and technology markets in China, today announced that its founder, CEO and Chairman, Jeffrey Kang, submitted a proposal to the Cogo Board of Directors for the purchase of approximately 30.5% of Cogo’s net assets, which as of the first quarter of 2013, generated approximately 98.7% of Cogo’s revenues through a company he wholly owns, Brilliant Group Global Limited (“Brilliant Group”).
The proposed purchase price is US$80 million. Mr. Kang has proposed that the transaction close before the end of 2013. Since this is a related-party transaction, the Board of Directors has delegated the review and negotiation of the potential transaction to the Company’s Audit Committee, which is comprised of three independent directors. The Audit Committee is expected to oversee the entire process. In accordance with the Company’s organizational documents, the Company anticipates that it will hold a meeting of stockholders to approve the transaction if the transaction is approved by Audit Committee.
As a condition of the proposed transaction, Brilliant Group would be required to pay $750,000 to Cogo on a quarterly basis for Cogo’s remaining subsidiaries and the target companies to continue to provide cross guarantees to each other until the end of 2014. Consideration is proposed to be payable in 2 installments, of which $10 million would be payable on Closing and $70 million by the end of 2013.
Upon completion of the transaction, Net Asset Value of Cogo shares is expected to be more than $6 a share. At the NASDAQ close on July 12, 2013, Cogo’s share price was $2.05 a share.
Based on Cogo’s Q1 2013 unaudited results as filed on Form 6-K on May 31, 2013, the proposed target assets represent approximately 30.5% of the Company’s net assets, 98.7% of its revenues and 66.5% of its gross profit.
A portion of the proceeds of the sale will be reserved for Cogo’s buyback program. There are more than 3.6 million outstanding shares under Cogo’s current buyback program authorized for repurchase out of the original 10 million shares. Management plans to authorize another plan to repurchase up to 10 million shares upon completion of the current program. As of July 12, 2013, there are approximately 29.4 million outstanding shares, of which insiders own approximately 40.8%. The Company will continue to disclose all material information relating to the proposed transaction in order to be able to continue to execute buyback program in accordance with applicable securities law requirements.
“This proposed deal is set to maximize shareholder value, and I am excited about what it means for our shareholders,” said Mr. Kang. “Upon the completion of this deal, Cogo is estimated to have more than $140 million net cash based on Q1’s financials and other assets, and a small amount of higher margin services and system solution revenue. The deal will help the Company evolve into a light asset, service revenue oriented business. The Company has no intention to dissolve or go private. The plan is to maintain the Company’s listing position with a business focus that aims to create greater value for shareholders.”
About Cogo Group, Inc.:
Cogo Group, Inc. (Nasdaq: COGO) is the leading gateway for global semiconductor companies to access the rapidly growing Industrial and Technology sectors in China. Through its unique business-to-business services platform, Cogo designs customized embedded solutions using technology from suppliers including Broadcom, Xilinx, Atmel and others for a customer base of over 2,100 Chinese OEMs/ODMs. Cogo’s customer list includes approximately 100 blue-chip companies, including ZTE, BYD and NARI, as well as nearly 2,000 Small and Medium Enterprises (SMEs). The Company serves a broad list of rapidly growing end-markets in China, including 3G Smartphones, Tablets, Automotives, High-Speed Railway, Smart Meter/Smart Grid, Healthcare and High Definition Television “HDTV.”
For further information:
Investor Relations
www.cogo.com.cn/investorinfo.html
communications@cogo.com.cn
H.K.: +852 2730 1518
U.S.: +1 (646) 291 8998
Fax: +86 755 2674 3522
Safe Harbor Statement:
This press release includes certain statements that are not descriptions of historical facts, but are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities and Exchange Act of 1934. These forward-looking statements may include statements about our proposed discussions related to our business or growth strategy such as growth in new business initiatives or potential disposals and acquisitions, all of which are subject to change. Such information is based upon expectations of our management that were reasonable when made, but may prove to be incorrect. All 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. For further descriptions of other risks and uncertainties, see our most recent Annual Report filed with the Securities and Exchange Commission (SEC) on Form 20-F, 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 www.sec.gov.
[1] Closing price as of July 12, 2013
(IQNT) Inteliquent Increases 2013 Financial Estimates
CHICAGO, July 15, 2013 (GLOBE NEWSWIRE) — Inteliquent, Inc. (Nasdaq:IQNT), a leading provider of voice services, today announced that it is revising its 2013 financial estimates as follows:
Revised Estimates | |
Revenue | $215—$225 million |
Adjusted EBITDA* | $57—$62 million |
Capital Expenditures | $12—$16 million |
The financial estimates include the results for Inteliquent’s global data business prior to its divestiture on April 30, 2013.
*Adjusted EBITDA (a non-GAAP financial measure). See “Use of Non-GAAP Financial Measures” below for a discussion of the presentation of Adjusted EBITDA and reconciliation to net income.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” that involve substantial risks and uncertainties. All statements, other than statements of historical fact, included in this press release are forward-looking statements. The words “anticipates,” “believes,” “efforts,” “expects,” “estimates,” “projects,” “proposed,” “plans,” “intends,” “may,” “will,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Factors that might cause such differences include, but are not limited to: the effects of competition, including direct connects, and downward pricing pressure resulting from such competition; risks associated with the sale of our data business, including issues regarding separating our network, IT and billing systems from the network and systems sold to the buyer, and that the cost savings and other benefits we hope to receive may not materialize in part or at all; our ability to maintain relationships with business providers following the sale of the data business; our regular review of strategic alternatives; the impact of current and future regulation, including intercarrier compensation reform enacted by the Federal Communications Commission; the risks associated with our ability to successfully develop and market new services, many of which are beyond our control and all of which could delay or negatively affect our ability to offer or market new services; technological developments; the ability to obtain and protect intellectual property rights; the impact of current or future litigation; the potential impact of any future acquisitions, mergers or divestitures; natural or man-made disasters; the ability to attract, develop and retain executives and other qualified employees; changes in general economic or market conditions; and other important factors included in our reports filed with the Securities and Exchange Commission, particularly in the “Risk Factors” section in our Annual Report on Form 10-K for the period ended December 31, 2012, as such Risk Factors may be updated from time to time in subsequent reports. Furthermore, such forward-looking statements speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements.
About Inteliquent
Headquartered in Chicago, Inteliquent is a leading provider of wholesale voice services for carriers and service providers. Inteliquent is used by nearly all national and regional wireless carriers, cable companies and CLECs in the markets it serves, and its network carries approximately ten billion minutes of traffic per month. Please visit Inteliquent’s website at www.inteliquent.com and follow us on Twitter@Inteliquent.
Use of Non-GAAP Financial Measures
In this press release we disclose “Adjusted EBITDA”, which is a non-GAAP financial measure. For purposes of SEC rules, a non-GAAP financial measure is a numerical measure of a company’s performance, financial position, or cash flows that either excludes or includes amounts that are not normally excluded or included in the most directly comparable measure, calculated and prepared in accordance with generally accepted accounting principles in the United Sates (GAAP). EBITDA is defined as net income before (a) interest expense, net (b) income tax expense and (c) depreciation and amortization. Adjusted EBITDA is defined as EBITDA as further adjusted to eliminate non-cash share-based compensation and any gain on sale on the divestiture of the Company’s global data business. We believe that the presentation of Adjusted EBITDA included in this press release provides useful information to investors regarding our results of operations because it assists in analyzing and benchmarking the performance and value of our business. We believe that presenting Adjusted EBITDA facilitates company-to-company operating performance comparisons of companies within the same or similar industries by backing out differences caused by variations in capital structure, taxation and depreciation of facilities and equipment (affecting relative depreciation expense), which may vary for different companies for reasons unrelated to operating performance. These measures provide an assessment of controllable operating expenses and afford management the ability to make decisions which are expected to facilitate meeting current financial goals as well as achieve optimal financial performance. They provide an indicator for management to determine if adjustments to current spending decisions are needed. Furthermore, we believe that the presentation of Adjusted EBITDA has economic substance because it provides important insight into our profitability trends, as a component of net income, and allows management and investors to analyze operating results with and without the impact of depreciation and amortization, interest and income tax expense, non-cash share-based compensation and any gain on sale on the divestiture of the Company’s global data business. Accordingly, these metrics measure our financial performance based on operational factors that management can impact in the short-term, namely the operational cost structure and expenses of our business. In addition, we believe Adjusted EBITDA is used by securities analysts, investors and other interested parties in evaluating companies, many of which present an EBITDA measure when reporting their results. Although we use Adjusted EBITDA as a financial measure to assess the performance of our business, the use of Adjusted EBITDA is limited because it does not include certain material costs, such as depreciation, amortization and interest and taxes, necessary to operate our business. We disclose the reconciliation between EBITDA and Adjusted EBITDA and net income below to compensate for this limitation. While we use net income as a significant measure of profitability, we also believe that Adjusted EBITDA, when presented along with net income, provides balanced disclosure which, for the reasons set forth above, is useful to investors in evaluating our operating performance and profitability. Adjusted EBITDA included in this press release should be considered in addition to, and not as a substitute for, net income as calculated in accordance with generally accepted accounting principles as a measure of performance.
INTELIQUENT, INC. AND SUBSIDIARIES | |
Reconciliation of Non-GAAP Financial Measures to GAAP Financial Measures | |
(Unaudited) | |
(Dollars in thousands) | |
The following is a reconciliation of net income to EBITDA and Adjusted EBITDA: |
|
2013* | |
Net income | $22,210 |
Interest income | (10) |
Provision for income taxes | 13,600 |
Depreciation and amortization | 16,200 |
EBITDA | $52,000 |
Non-cash share-based compensation | 7,500 |
Adjusted EBITDA | $59,500 |
*The amounts expressed in this column are based on current estimates as of the date of this press release. This reconciliation is based on the midpoint of the full year 2013 estimated range announced in this press release. The financial estimates include results from the global data services business for the first four months of 2013 only. |
CONTACT: Investor Contact: Inteliquent Darren Burgener (312) 380-4548
(CLPI) Calpian’s Money-on-Mobile Grows to Serve over 57 Million Unique Users
Calpian, Inc. (OTC:CLPI) announced today that, as of June 30, 2013, the Money-on-Mobile service offered by its Indian subsidiary is now being supported by 143,057 retail locations, increased from 138,711 on May 31, 2013. Additionally, Money-on-Mobile was accessed by approximately 57.8 million unique phone number customers as of June 30, 2013, up from the 53 million reported from the previous month.
According to Calpian CEO, Harold Montgomery, “With the recent launch of an Android solution, Money-on-Mobile is poised to extend its growth into entirely new Indian consumer markets. We could not be more pleased with its performance.”
About Calpian, Inc.
Calpian, Inc. (CLPI) is a publicly traded company with corporate offices in Dallas, Texas, operating centers in Georgia, New York and Illinois and mobile payments emerging-market operations through its subsidiary in India.
Calpian’s Indian subsidiary offers Money-on-Mobile, a pre-paid mobile payment solution, to more than 143,057 Indian retail locations. Calpian’s management team has over 70 years in combined experience in the payments business. Calpian’s CEO, Harold Montgomery, is a recognized industry leader who has provided expert testimony to the U.S. Congress and Federal Reserve Bank on payments-related issues and regularly appears in numerous industry publications, such as Transaction World Magazine. Please visit our website at www.calpian.com for more information.
(JMSN) Jameson Stanford Resources Details Current Projects
Jameson Stanford Resources Details Current Projects
LAS VEGAS, NV–(Marketwired – Jul 15, 2013) – Jameson Stanford Resources Corp. (OTCBB: JMSN) (the “Company”), a metals and minerals exploration, development and production company, wishes to provide detailed information on its three current projects, each of which represent a very credible opportunity for the extraction and sale of high quality ores and precious metals.
“The preliminary geological reports have confirmed that our sites contain substantial reserves of high-grade copper, gold and silver as well as other highly marketable metals,” commented Michael Stanford, President and CEO of Jameson Stanford Resources. “We have enlisted some of the top names in the mining industry to complete testing and create the necessary assay and industry reports that we believe will translate into substantial shareholder value as we get further into our next phase of production and delivery.”
Star Mountain (Star Mining District) – The Star Mountain project consists of 117 lode mining claims and four metalliferous mineral lease sections located in the Star Mountain range, Star Mining District, in Beaver County, Utah. Based on the Company’s geological analysis, magnetometry studies and reverse circulation drilling samples, it is estimated that total inferred reserves at the Star Mountain site may ultimately involve more than 100,000,000 metric tons of copper ore, plus additional precious and base metals.
Spor Mountain (Spor Mountain Mining District) – The Spor Mountain project consists of nine lode mining claims and three metalliferous mineral lease sections located in Juab County, Utah. Jameson Stanford Resources’ Spor Mountain/Dugway Minerals project involves total area of 2,098 acres. Based on the company’s preliminary geological analysis and two prospect pit excavations, it is estimated that total inferred reserves at the Dugway Minerals site may ultimately involve more than 4,000,000 ounces of silver, commercial concentrations of beryllium, and other precious and base metals. Planned project activities at Spor Mountain in 2012-2013 include prospecting, exploration and development.
Ogden Bay Minerals – The Ogden Bay Minerals property represents a developing mineral excavation project on federal protected wetlands and river systems across 25 square miles of land area known as North Delta, located in West Ogden, Utah. Jameson Stanford Resources was commissioned by the State of Utah Division of Natural Resources, USDA Natural Resources Conservation Service and Weber County Emergency Management to restore wildlife habitat, repair damage, dredge silt and sand, and remove debris from the Weber River. The project contains deposits of alluvial mineral deposits that are created and replenished from 125 miles of river flow from the nearby Wasatch Mountain Range. These alluvial mineral deposits have commercial grades of zircon, usable silica, and other heavy mineral ore.
Jameson Stanford Resources intends to make the results of the technical studies public when available and deemed appropriate.
About Jameson Stanford Resources Corp.
Jameson Stanford Resources is focused on developing significant mining claims, mineral leases and excavation rights for projects located in historic mining districts and other sites in central and southwestern Utah. The Company is presently engaged in exploration and development activities in connection with two high-grade copper, gold, silver and base metals properties located in historic mining districts in Beaver County and Juab County, Utah. In addition, Jameson Stanford Resources has acquired excavation rights and special permitting related to deposits of alluvial minerals and silica sand located in Weber County, Utah.
Safe Harbor Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including those set forth in the Company’s Form 10-K filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.
Contact:
Jameson Stanford Resources Corp.
Las Vegas, NV
www.JamesonStanford.com
702-933-0808
IR@JamesonStanford.com
Mission Investor Relations
Atlanta, GA
www.MissionIR.com
404-941-8975
Investors@MissionIR.com
(URRE) Announces Amended Uranium Supply Contract
Agreement Paves the Way for Return to Production in Texas
LEWISVILLE, Texas, July 12, 2013 (GLOBE NEWSWIRE) — Uranium Resources, Inc. (Nasdaq:URRE) (URI) today announced that it amended its uranium supply contract with ITOCHU International Inc. effective July 11, 2013, to include a new sales pricing structure, new delivery dates and quantity levels.
Pursuant to the amended agreement, ITOCHU would purchase one-half of all production from URI’s Vasquez, Rosita or Kingsville properties up to three million pounds of U3O8. Any new production outside of those areas is not subject to the agreement. The purchase price will be based on published market prices at the time of delivery subject to a five percent discount when the market price is $56.50 per pound of U3O8 or less, or seven percent when greater than $56.50 per pound.
“Given the current dynamics in our industry, renegotiating our supply contract was an important step in our strategic plan to resume production activities in Texas,” stated Christopher M. Jones, President and CEO of URI. “This agreement improves the economics of production from our facilities and builds on our long-term relationship with ITOCHU by providing them access to a supply of uranium.”
About Uranium Resources, Inc.
Uranium Resources, Inc. explores for, develops and mines uranium. Since its incorporation in 1977, URI has produced uranium by in-situ recovery (ISR) methods in Texas and currently has a number of initiatives underway to return the Company to production. URI has over 206,600 acres of uranium mineral holdings and 144.8 million pounds of in-place mineralized uranium material in New Mexico and an NRC license to produce up to 3 million pounds of uranium per year. URI has an additional 664,000 pounds of in-place reserves in Texas. The Company acquired these properties over the past 20 years along with an extensive information database of historic drill hole logs, assay certificates, maps and technical reports.
Uranium Resources routinely posts news and other information about the Company on its website at www.uraniumresources.com.
Safe Harbor Statement
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to risks, uncertainties and assumptions and are identified by words such as “expects,” “estimates,” “projects,” “anticipates,” “believes,” “could,” and other similar words. All statements addressing operating performance, events, or developments that the Company expects or anticipates will occur in the future, including but not limited to statements relating to the Company’s mineralized uranium materials, development plans for properties in South Texas and New Mexico and returning to production are forward-looking statements. Because they are forward-looking, they should be evaluated in light of important risk factors and uncertainties. These risk factors and uncertainties include, but are not limited to, the Company’s ability to raise additional capital in the future, spot price and long-term contract price of uranium, the outcome of negotiations with the Navajo Nation, the Company’s ability to reach agreements with current royalty holders, weather conditions, operating conditions at the Company’s mining projects, government and tribal regulation of the mining industry and the nuclear power industry, world-wide uranium supply and demand, availability of capital, timely receipt of mining and other permits from regulatory agents, maintaining sufficient financial assurance in the form of sufficiently collateralized surety instruments and other factors which are more fully described in the Company’s documents filed with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should any of the Company’s underlying assumptions prove incorrect, actual results may vary materially from those currently anticipated. In addition, undue reliance should not be placed on the Company’s forward-looking statements. Except as required by law, the Company disclaims any obligation to update or publicly announce any revisions to any of the forward-looking statements contained in this news release.
CONTACT: Investor Contact: Deborah K. Pawlowski Kei Advisors LLC Phone: 716.843.3908 Email: dpawlowski@keiadvisors.com
(QGEN) Receives FDA Approval for therascreen® EGFR RGQ PCR Kit
GERMANTOWN, Maryland, and HILDEN, Germany, July 12, 2013 /PRNewswire/ —
- U.S. launch of therascreen EGFR RGQ PCR Kit (therascreen EGFR test) follows FDA approval of system to select non-small cell lung cancer (NSCLC) patients eligible for treatment with GILOTRIF™ (afatinib)
- therascreen EGFR test addresses high volume, high value need with the broadest coverage of validated mutations
- Patients and healthcare providers benefit from reliable FDA-approved companion diagnostic to guide the use of new therapy targeting patients with EGFR gene mutations
- Laboratories gain additional content for high performance Rotor-Gene Q MDx
QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced it has received approval by the U.S. Food and Drug Administration (FDA) to market the therascreen EGFR test as a companion diagnostic to guide the use of Boehringer Ingelheim’s new targeted therapy, GILOTRIF™ (afatinib), for treatment of metastatic NSCLC in patients whose tumors have certain EGFR gene mutations. More than 200,000 new lung cancer cases are diagnosed every year in the United States, with NSCLC accounting for approximately 85% of cases, leading to an estimated 160,000 deaths.
The therascreen EGFR test enables doctors to identify EGFR mutation-positive patients eligible for treatment with GILOTRIF™ (afatinib). The FDA approval of the therascreen EGFR test marks a further milestone in the global expansion of QIAGEN’s Personalized Healthcare franchise – and adds a third FDA-approved or cleared diagnostic kit to run on QIAGEN’s efficient Rotor-Gene Q MDx. Approximately 120,000 metastatic NSCLC patients each year in the U.S. could benefit from testing for EGFR mutations, a total potential testing market of about $35 million, according to QIAGEN estimates.
“We are very pleased to receive approval to market our therascreen EGFR test in the United States, a successful outcome from our collaboration with Boehringer Ingelheim. QIAGEN’s companion diagnostics are transforming patient care and extending lives around the world by providing personalized genomic information to guide treatment decisions,” said Peer M. Schatz, Chief Executive Officer of QIAGEN N.V. “The U.S. launch of the therascreen EGFR test adds to our growing menu of FDA-approved diagnostics running on the Rotor-Gene Q MDx, a real-time PCR platform in our revolutionary QIAsymphony family. Following the 2012 launch of our therascreen KRAS RGQ PCR Kit (therascreen KRAS test) in colorectal cancer, U.S. laboratories already have adopted this test for more than half of the KRAS testing volume.”
Benefiting patients and healthcare providers
FDA approval of the therascreen EGFR test follows an FDA priority review of GILOTRIF™ (afatinib), and the drug’s labeling requires the use of an FDA-approved test to select EGFR mutation-positive patients for the therapy. GILOTRIF™ (afatinib) is indicated for NSCLC patients with the most common mutations in the EGFR gene which are EGFR exon 19 deletions and exon 21 L858R substitution mutations.
EGFR (the epidermal growth factor receptor) is a protein found on the surface of cells. In some patients, genetic mutations involving EGFR lead to constant activation, which is associated with uncontrolled cell division and development of advanced NSCLC. By using a companion diagnostic to identify patients whose cancer involves these EGFR mutations, oncologists can determine who is likely to benefit from targeted therapy that inhibits the EGFR protein.
Analytical performance of the therascreen EGFR test has been established for 21 EGFR mutations, including the most prevalent resistance mutation (T790M). The therascreen EGFR test also includes certain unique features that are valuable for pathologists, such as the detection of EGFR mutations in separate tubes.
Unlike laboratory-developed tests (LDTs), QIAGEN’s therascreen EGFR test technology offers performance proven by comprehensive analytical studies and clinical data. The kit covers the complete workflow from sample preparation to detection technology, through generation of test reports by the Rotor-Gene Q MDx. This standardized workflow delivers reproducible and objective results for oncologists. QIAGEN will provide laboratories with conversion and validation support for the therascreen EGFR test, plus ongoing assistance with co-marketing and reimbursement. At the Annual Meeting of the American Society of Clinical Oncology last month, FDA commissioner Margaret A. Hamburg, M.D., announced plans that the Agency will enforce regulations against LDTs, stating that FDA “is working to make sure that the accuracy and clinical validity of high-risks tests are established before they come to market.”
Adding value to QIAGEN’s Instrument platforms
The therascreen EGFR test offers laboratories an efficient workflow on the Rotor-Gene Q MDx, a molecular detection instrument that uses real-time PCR technology. The Rotor-Gene Q MDx is part of the QIAsymphony family of products. The therascreen EGFR test is the second FDA-approved companion diagnostic to run on the Rotor-Gene Q MDx. The instrument was approved as part of the system on which the therascreen® KRAS test runs for colorectal cancer patients. Most major U.S. laboratories have adopted the therascreen KRAS test and the Rotor-Gene Q MDx.
QIAGEN continues to expand its pipeline of Personalized Healthcare technologies and intends to submit more tests for U.S. clearance or approval to run on the Rotor-Gene Q MDx, including a JAK2 RGQ PCR kit and a companion diagnostic paired with a new lung cancer compound from Pfizer. The company already markets Personalized Healthcare tests covering about 30 biomarkers in Europe, Asia/Pacific and Japan. QIAGEN is developing many of these companion diagnostics, plus a range of other molecular tests, for submission to the FDA as part of a broad menu of reliable, cost-effective molecular diagnostics.
In addition, QIAGEN has more than 15 projects to co-develop and market companion diagnostics with leading pharmaceutical and biotech companies such as Amgen, AstraZeneca, Bristol-Myers Squibb, Eli Lilly and Company, and Pfizer.
About QIAGEN
QIAGEN N.V., a Netherlands holding company, is the leading global provider of Sample & Assay Technologies that are used to transform biological materials into valuable molecular information. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are then used to make these isolated biomolecules visible and ready for interpretation. QIAGEN markets more than 500 products around the world, selling both consumable kits and automation systems to customers through four customer classes: Molecular Diagnostics (human healthcare), Applied Testing (forensics, veterinary testing and food safety), Pharma (pharmaceutical and biotechnology companies) and Academia (life sciences research). As of March 31, 2013, QIAGEN employed approximately 4,000 people in more than 35 locations worldwide. Further information can be found at http://www.qiagen.com/.
Certain of the statements contained in this news release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN’s products, markets, strategy or operating results, including without limitation its expected operating results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products in applied testing, personalized healthcare, clinical research, proteomics, women’s health/ HPV testing and nucleic acid-based molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN’s products (including fluctuations due to general economic conditions, the level and timing of customers’ funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN’s products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors’ products; market acceptance of QIAGEN’s new products, the consummation of acquisitions, and the integration of acquired technologies and businesses. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).
###
Contacts:
Public Relations:
Dr. Thomas Theuringer
Director Public Relations
+49-2103-29-11826
+1-240-686-7425
Email: pr@qiagen.com
http://www.twitter.com/qiagen
http://www.qiagen.com/About-Us/Press-and-Media/
Investor Relations:
John Gilardi
VP Corporate Communications
+49-2103-29-11711
+1-240-686-2222
Email: ir@qiagen.com
http://www.qiagen.com/About-Us/Investors/
(CONN) New Store Opens in Mesa, Arizona
Conn’s, Inc. (NASDAQ: CONN), a specialty retailer of home appliances, furniture, mattresses, consumer electronics and provider of consumer credit, today announced the opening of a Conn’s HomePlus™ store in Mesa, Arizona. This is Conn’s first new store in the Phoenix metropolitan market.
Located at 1655 S. Stapley Drive, the new Conn’s HomePlus store format showcases furniture and mattresses in addition to the leading brands and the latest technologies in consumer electronics and home appliances.
About Conn’s, Inc.
Conn’s is a specialty retailer currently operating 71 retail locations, with 58 in Texas, six in Louisiana, three in Oklahoma, two in New Mexico and two in Arizona. The Company’s primary product categories include:
- Home appliance, including refrigerators, freezers, washers, dryers, dishwashers and ranges;
- Furniture and mattress, including furniture and related accessories for the living room, dining room and bedroom, as well as both traditional and specialty mattresses;
- Consumer electronic, including LCD, LED, 3-D and plasma televisions, Blu-ray players, home theater and video game products, camcorders, digital cameras, and portable audio equipment; and
- Home office, including computers, tablets, printers and accessories.
Additionally, the Company offers a variety of products on a seasonal basis, including lawn and garden equipment, room air conditioners and outdoor furniture. Unlike many of its competitors, the Company provides flexible in-house credit options for its customers, in addition to third-party financing programs and third-party rent-to-own payment plans.
(SPRD) Enters into Merger Agreement to be Acquired by Tsinghua Unigroup
SHANGHAI, July 12, 2013 /PRNewswire/ — Tsinghua Unigroup Ltd. (“Tsinghua Unigroup”), an operating subsidiary of Tsinghua Holdings Co. Ltd., a solely state-owned limited liability corporation funded by Tsinghua University in China, and Spreadtrum Communications, Inc. (NASDAQ: SPRD; “Spreadtrum” or the “Company“), a leading fabless semiconductor provider in China with advanced technology in 2G, 3G and 4G wireless communications standards, today jointly announced that they have entered into a definitive merger agreement under which Tsinghua Unigroup will acquire all of the outstanding Ordinary Shares of Spreadtrum for US$31.00 per American Depositary Share (or US$10.33 per Ordinary Share, each American Depositary Share representing three Ordinary Shares). The merger values Spreadtrum’s equity at approximately US$1.78 billion, on a fully diluted basis. The transaction is subject to approval by the shareholders of Spreadtrum, and antitrust and other regulatory approvals, and is not subject to any financing condition.
The Company’s Board of Directors unanimously approved the merger agreement and recommends that the Company’s shareholders vote to approve the merger agreement. Spreadtrum expects to hold a special meeting of its shareholders to consider and act upon the proposed transaction as promptly as practicable. Details regarding the record date for, and the date, time and place of, the special meetings will be included in a press release when finalized.
With annual revenues of approximately US$720 million as of 2012, Spreadtrum is a fabless semiconductor company that develops mobile chipset platforms for smartphones, feature phones and other consumer electronics products, supporting 2G, 3G and 4G wireless communications standards. Spreadtrum’s solutions combine its highly integrated, power-efficient chipsets with customizable software and reference designs in a complete turnkey platform, enabling customers to achieve faster design cycles with a lower development cost. Spreadtrum’s customers include global and China-based manufacturers developing mobile products for consumers in China and emerging markets around the world.
“We believe Spreadtrum and Tsinghua Unigroup will supplement each other and create enormous synergies in China and abroad,” commented Mr. Zhao Weiguo, Chairman and Chief Executive Officer of Tsinghua Unigroup. He continued, “Spreadtrum’s capable and talented management team will be encouraged to continue their strong performance and innovative corporate culture, while Tsinghua Unigroup is in the unique position to offer unique expertise in consumer products, protection and support from a vast IP portfolio, and unique access to important capital markets in China.”
Dr. Leo Liyou Li, Chairman and Chief Executive Officer of Spreadtrum said, “The acquisition by Tsinghua will provide investors with significant returns, and position the Spreadtrum business for continued growth. The vast IP portfolio of Tsinghua Unigroup and Tsinghua University also gives the original Spreadtrum business advantageous boosts in the area of IP protection. In short, we feel this transaction is favorable to Spreadtrum shareholders, and unlocking potential value otherwise hidden in the assets of Spreadtrum.”
Morgan Stanley Asia Limited rendered a fairness opinion to the Board of Directors of Spreadtrum. Fenwick & West LLP is serving as legal advisor to Spreadtrum, and Morrison & Foerster LLP is serving as legal advisor to Tsinghua Unigroup.
Spreadtrum will furnish to the Securities and Exchange Commission (the “SEC”) a Report on Form 6-K regarding the transaction, which will include the merger agreement. All parties desiring details regarding the transaction are urged to review these documents, which are available at the SEC’s website (http://www.sec.gov).
This announcement is neither a solicitation of proxies, an offer to purchase nor a solicitation of an offer to sell any securities and it is not a substitute for any proxy statement or other proxy materials that may be filed or furnished with the SEC with respect to the proposed merger.
About Tsinghua Unigroup Ltd.
Tsinghua Unigroup Ltd. (“Unigroup”) is an operating subsidiary of Tsinghua Holdings Co. Ltd., a solely state-owned limited liability corporation funded by Tsinghua University in China. Tsinghua Holdings Co. Ltd. is the controlling shareholder of Unigroup. The other shareholder is Beijing Jiankun Investment Group Co. Ltd. Unigroup’s business lines include high-technology, bio-technology, science park development, and urban infrastructure construction.
About Spreadtrum Communications, Inc.
Spreadtrum Communications, Inc. (NASDAQ: SPRD; “Spreadtrum“) is a fabless semiconductor company that develops mobile chipset platforms for smartphones, feature phones and other consumer electronics products, supporting 2G, 3G and 4G wireless communications standards. Spreadtrum’s solutions combine its highly integrated, power-efficient chipsets with customizable software and reference designs in a complete turnkey platform, enabling customers to achieve faster design cycles with a lower development cost. Spreadtrum’s customers include global and China-based manufacturers developing mobile products for consumers in China and emerging markets around the world. For more information, visit www.Spreadtrum.com.
SAFE HARBOR STATEMENT:
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, without limitation, statements regarding the synergies between Spreadtrum and Tsinghua, positioning the Company’s business for continued growth, the increased intellectual property protection for the Company, the unlocking of hidden value, and other anticipated benefits of the merger for shareholders. The Company uses words like “believe,” “anticipate,” “intend,” “estimate,” “expect,” “project” and similar expressions to identify forward-looking statements, although not all forward-looking statements contain these words. These statements are forward-looking in nature and involve risks and uncertainties that may cause actual market trends and the Company’s actual results to differ materially from those expressed or implied in these forward-looking statements for a variety of reasons. Potential risks and uncertainties include, but are not limited to, continuing competitive pressure in the semiconductor industry and the effect of such pressure on prices; unpredictable changes in technology and consumer demand for mobile phones; market acceptance of the Company’s smartphone products; transition trend from 2.5G feature phones to smartphones; the state of and any change in the Company’s relationship with its major domestic and international customers and Chinese government agencies; and changes in political, economic, legal and social conditions in China. For additional discussion of these risks and uncertainties and other factors, please consider the information contained in the Company’s filings with the U.S. Securities and Exchange Commission (the “SEC”) and the annual report on Form 20-F filed on April 26, 2013 especially the section under “Risk Factors” and such other documents that the Company may file with the SEC from time to time, including on Form 6-K. The Company assumes no obligation to update any forward-looking statements, which apply only as of the date of this press release, and does not intend to update any forward-looking statement whether as a result of new information, future events or otherwise except as required by law.
(WBMD) Announces Preliminary Q2, Increases Financial Guidance for 2013
NEW YORK, July 12, 2013 /PRNewswire/ — WebMD Health Corp. (NASDAQ: WBMD), the leading source of health information, today announced preliminary financial results for the three months ended June 30, 2013 and increased financial guidance for 2013.
Preliminary Results for the Three Months Ended June 30, 2013
For the three months ended June 30, 2013, WebMD expects:
- Revenue to be between $124 million and $125 million, an increase of 10% to 11% from the prior year period. Prior financial guidance provided for revenue to be in excess of $115 million.
- Earnings before interest, taxes, non-cash and other items (“Adjusted EBITDA”) to be approximately $29 million, or approximately 23% of revenue, an increase of 104% from the prior year period. Prior financial guidance provided for Adjusted EBITDA, as a percentage of revenue, to be in excess of 18%.
- Net income to be approximately $3 million, or $0.05 per diluted share, or approximately 2% of revenue. Prior financial guidance provided for net loss, as a percentage of revenue, to be approximately (1%).
Balance Sheet Highlights
As of June 30, 2013, WebMD had approximately $1 billion in cash and cash equivalents and $800 million in aggregate principal amount of convertible notes outstanding.
Traffic Highlights
Traffic to the WebMD Health Network during the second quarter reached an average of 125.5 million unique users per month and total traffic of 2.64 billion page views for the quarter, increases of 17% and 6%, respectively, from the prior year period.
Increased 2013 Financial Guidance
WebMD has increased its financial guidance for 2013 and expects the following:
- Revenue of $485 million to $505 million, an increase of 3% to 7% from the prior year. Prior financial guidance provided for revenue of $450 million to $470 million.
- Adjusted EBITDA of $100 million to $110 million, an increase of 37% to 50% from the prior year. Prior financial guidance provided for Adjusted EBITDA of $75 million to $88 million.
- Net income of $3 million to $11 million. Prior financial guidance provided for net loss of $(13) million to $(1.5) million.
WebMD’s prior financial guidance for 2013 was last disseminated on May 7, 2013.
WebMD expects 2013 revenue of $485 million to $505 million to assume the following distribution:
- Approximately 83% from public portals advertising and sponsorship, representing growth of approximately 3% to 7% over the prior year, and
- Approximately 17% from private portal licensing, representing growth of approximately 5% to 9% over the prior year.
WebMD’s revised guidance reflects: (a) actual results for the first half of 2013; (b) improved visibility for the second half of 2013 based upon several factors, including orders received to date and those expected over the balance of the year; and (c) anticipated expenses relating to new private portal customer implementations as well as public portal initiatives such as enhanced data and analytics and new content and enhanced offerings for both users and advertisers.
“Our better than anticipated second quarter preliminary results and our increased financial guidance for 2013 is primarily due to increased demand for our public portals advertising and sponsorship services, particularly from biopharmaceutical customers,” said David J. Schlanger, Interim CEO, WebMD. “Additionally, while not impacting our increased 2013 guidance, we are experiencing significant new commitments for our private portal offerings, including the previously announced contract with Blue Cross and Blue Shield Association Federal Employee Program, which are expected to generate revenue beginning in 2014.”
A schedule outlining WebMD’s preliminary second quarter results and updated 2013 financial guidance is attached to this press release.
Final Results to Be Released on July 31, 2013
The information in this release is preliminary. WebMD is completing its normal closing process and will release its second quarter results on July 31, 2013, at approximately 4:00 p.m. (Eastern time) and will hold a conference call with investors and analysts to discuss its second quarter results at 4:45 p.m. (Eastern time) on that day. The call can be accessed at www.wbmd.com (in the Investor Relations section). A replay of the audio webcast will be available at the same web address.
About WebMD
WebMD Health Corp. (NASDAQ: WBMD) is the leading provider of health information services, serving consumers, physicians, healthcare professionals, employers, and health plans through our public and private online portals, mobile platforms and health-focused publications.
The WebMD Health Network includes WebMD Health, Medscape, MedicineNet, eMedicineHealth, RxList, theheart.org, Medscape Education and other owned WebMD sites.
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All statements contained in this press release other than statements of historical fact, are forward-looking statements, including those regarding: our preliminary second quarter results (which reflect what we currently expect to report and is subject to adjustment); guidance on our future financial results and other projections or measures of our future performance; market opportunities and our ability to capitalize on them; and the benefits expected from new or expected contracts with customers, from new or updated products or services and from other potential sources of additional revenue. These statements speak only as of the date of this press release, are based on our current plans and expectations, and involve risks and uncertainties that could cause actual future events or results to be different than those described in or implied by such forward-looking statements. These risks and uncertainties include those relating to: market acceptance of our products and services; our relationships with customers and strategic partners; and changes in economic, political or regulatory conditions or other trends affecting the healthcare, Internet and information technology industries. Further information about these matters can be found in our Securities and Exchange Commission filings and this press release is intended to be read in conjunction with those filings. Except as required by applicable law or regulation, we do not undertake any obligation to update our forward-looking statements to reflect future events or circumstances.
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This press release, and the accompanying tables, include both financial measures in accordance with accounting principles generally accepted in the United States of America, or GAAP, as well as certain non-GAAP financial measures. The tables attached to this press release include reconciliations of these non-GAAP financial measures to GAAP financial measures. In addition, an “Explanation of Non-GAAP Financial Measures” is attached to this press release as Annex A.
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WebMD®, Medscape®, CME Circle®, Medpulse®, eMedicine®, MedicineNet®, theheart.org® and RxList® are among the trademarks of WebMD Health Corp. or its subsidiaries.
WebMD Health Corp. | |||||||||
Preliminary Financial Information for the Quarter Ended June 30, 2013 | |||||||||
and Updated Financial Guidance Summary | |||||||||
(In millions, except per share amounts) | |||||||||
Quarter Ended | Year Ending | ||||||||
June 30, 2013 | December 31, 2013 | ||||||||
Preliminary Results | Guidance Range | ||||||||
Revenue | $ 124.0 | $ 125.0 | $ 485.0 | $ 505.0 | |||||
Earnings before interest, taxes, non-cash | |||||||||
and other items (“Adjusted EBITDA”) (a) | $ 29.0 | $ 29.5 | $ 100.0 | $ 110.0 | |||||
Interest, taxes, non-cash and other items (b) | |||||||||
Interest expense, net | (5.8) | (5.8) | (23.0) | (23.0) | |||||
Depreciation and amortization | (6.7) | (6.7) | (28.0) | (27.0) | |||||
Non-cash stock-based compensation | (11.2) | (11.2) | (39.0) | (37.0) | |||||
Other expense (c) | (1.4) | (1.4) | (1.4) | (1.4) | |||||
Pre-tax income | 3.9 | 4.4 | 8.6 | 21.6 | |||||
Income tax provision | (1.4) | (1.6) | (5.6) | (10.6) | |||||
Net income | $ 2.5 | $ 2.8 | $ 3.0 | $ 11.0 | |||||
Net income per share: | |||||||||
Basic | $ 0.05 | $ 0.06 | $ 0.06 | $ 0.22 | |||||
Diluted | $ 0.05 | $ 0.05 | $ 0.06 | $ 0.21 | |||||
Weighted-average shares outstanding usedin computing per share amounts: | |||||||||
Basic | 49.0 | 49.0 | 50.0 | 50.0 | |||||
Diluted | 51.0 | 51.0 | 52.0 | 52.0 | |||||
(a) See Annex A – Explanation of Non-GAAP Financial Measures | |||||||||
(b) Reconciliation of Adjusted EBITDA to Net Income | |||||||||
(c) Represents severance expense for the Company’s former Chief Executive Officer | |||||||||
Additional information regarding full year forecast: | |||||||||
– The distribution of the annual revenue is expected to be approximately 83% public portals advertising and sponsorship and 17% private portal licensing. Quarterly revenue distributions may vary from this annual estimate. | |||||||||
– Convertible Notes are not expected to be dilutive for the full year or any quarter. | |||||||||
The above guidance does not include the impact, if any, of future deployment of capital for items such as share repurchases or acquisitions, gains or losses from discontinued operations, or other non-recurring, one-time or unusual items. | |||||||||
ANNEX A
Explanation of Non-GAAP Financial Measures
The accompanying WebMD Health Corp. press release and attachment include both financial measures in accordance with U.S. generally accepted accounting principles, or GAAP, as well as non-GAAP financial measures. The non-GAAP financial measures represent earnings before interest, taxes, non-cash and other items (which we refer to as “Adjusted EBITDA”) and related per share amounts. Adjusted EBITDA should be viewed as supplemental to, and not as an alternative for net income or loss calculated in accordance with GAAP (referred to below as “net income”). The attachment to the press release includes reconciliations of non-GAAP financial measures to GAAP financial measures.
Adjusted EBITDA is used by our management as an additional measure of our company’s performance for purposes of business decision-making, including developing budgets, managing expenditures, and evaluating potential acquisitions or divestitures. Period-to-period comparisons of Adjusted EBITDA help our management identify additional trends in our company’s financial results that may not be shown solely by period-to-period comparisons of net income. In addition, we may use Adjusted EBITDA in the incentive compensation programs applicable to some of our employees in order to evaluate our company’s performance. Our management recognizes that Adjusted EBITDA has inherent limitations because of the excluded items, particularly those items that are recurring in nature. In order to compensate for those limitations, management also reviews the specific items that are excluded from Adjusted EBITDA, but included in net income, as well as trends in those items. The amounts of those items are set forth, for the applicable periods, in the reconciliations of Adjusted EBITDA to net income that accompany our press releases and disclosure documents containing non-GAAP financial measures, including the reconciliations contained in the accompanying press release attachment.
We believe that the presentation of Adjusted EBITDA is useful to investors in their analysis of our results for reasons similar to the reasons why our management finds it useful and because it helps facilitate investor understanding of decisions made by management in light of the performance metrics used in making those decisions. In addition, as more fully described below, we believe that providing Adjusted EBITDA, together with a reconciliation of Adjusted EBITDA to net income, helps investors make comparisons between our company and other companies that may have different capital structures, different effective income tax rates and tax attributes, different capitalized asset values and/or different forms of employee compensation. However, Adjusted EBITDA is intended to provide a supplemental way of comparing our company with other public companies and is not intended as a substitute for comparisons based on net income. In making any comparisons to other companies, investors need to be aware that companies use different non-GAAP measures to evaluate their financial performance. Investors should pay close attention to the specific definition being used and to the reconciliation between such measures and the corresponding GAAP measures provided by each company under applicable SEC rules.
The following is an explanation of the items excluded by us from Adjusted EBITDA but included in net income:
- Depreciation and Amortization. Depreciation and amortization expense is a non-cash expense relating to capital expenditures and intangible assets arising from acquisitions that are expensed on a straight-line basis over the estimated useful life of the related assets. We exclude depreciation and amortization expense from Adjusted EBITDA because we believe that (i) the amount of such expenses in any specific period may not directly correlate to the underlying performance of our business operations and (ii) such expenses can vary significantly between periods as a result of new acquisitions and full amortization of previously acquired tangible and intangible assets. Accordingly, we believe that this exclusion assists management and investors in making period-to-period comparisons of operating performance. Investors should note that the use of tangible and intangible assets contributed to revenue in the periods presented and will contribute to future revenue generation and should also note that such expense will recur in future periods.
- Stock-Based Compensation Expense. Stock-based compensation expense is a non-cash expense arising from the grant of stock-based awards to employees. We believe that excluding the effect of stock-based compensation from Adjusted EBITDA assists management and investors in making period-to-period comparisons in our company’s operating performance because (i) the amount of such expenses in any specific period may not directly correlate to the underlying performance of our business operations and (ii) such expenses can vary significantly between periods as a result of the timing of grants of new stock-based awards, including grants in connection with acquisitions. Additionally, we believe that excluding stock-based compensation from Adjusted EBITDA assists management and investors in making meaningful comparisons between our company’s operating performance and the operating performance of other companies that may use different forms of employee compensation or different valuation methodologies for their stock-based compensation. Investors should note that stock-based compensation is a key incentive offered to employees whose efforts contributed to the operating results in the periods presented and are expected to contribute to operating results in future periods. Investors should also note that such expenses will recur in the future.
- Interest Income and Expense. Interest income is associated with the level of marketable debt securities and other interest bearing accounts in which we invest, and interest expense is related to our company’s capital structure (including non-cash interest expense relating to our convertible notes). Interest income and expense varies over time due to a variety of financing transactions and due to acquisitions and divestitures that we have entered into or may enter into in the future. We have, in the past, issued convertible debentures, repurchased shares in cash tender offers and repurchased shares and convertible debentures through other repurchase transactions, and completed the divestiture of certain businesses. We exclude interest income and interest expense from Adjusted EBITDA (i) because these items are not directly attributable to the performance of our business operations and, accordingly, their exclusion assists management and investors in making period-to-period comparisons of operating performance and (ii) to assist management and investors in making comparisons to companies with different capital structures. Investors should note that interest income and expense will recur in future periods.
- Income Tax Provision (Benefit). We maintain a valuation allowance on a portion of our net deferred tax assets (including our net operating loss carryforwards), the amount of which may change from quarter to quarter based on factors that are not directly related to our results for the quarter. The valuation allowance is either adjusted through the statement of operations or additional paid-in capital. The timing of such adjustments has not been consistent and as a result, our income tax expense can fluctuate significantly from period to period in a manner not directly related to our operating performance. We exclude the income tax provision (benefit) from Adjusted EBITDA (i) because we believe that the income tax provision (benefit) is not directly attributable to the underlying performance of our business operations and, accordingly, its exclusion assists management and investors in making period-to-period comparisons of operating performance and (ii) to assist management and investors in making comparisons to companies with different tax attributes. Investors should note that income tax provision (benefit) will recur in future periods.
- Other Items. We engage in other activities and transactions that can impact our net income. In recent periods, these other items have included, but were not limited to: (i) gain or loss on investments; (ii) a restructuring charge; and (iii) severance expense. We exclude these other items from Adjusted EBITDA because we believe these activities or transactions are not directly attributable to the performance of our business operations and, accordingly, their exclusion assists management and investors in making period-to-period comparisons of operating performance. Investors should note that some of these other items may recur in future periods.
(BCRX) to File Peramivir NDA Supported by BARDA/HHS Funding
BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the Biomedical Advanced Research and Development Authority (BARDA/HHS) has released funding under the current $234.8 million contract to enable completion of a New Drug Application (NDA) filing for intravenous (i.v.) peramivir. BioCryst is seeking an indication for the treatment of acute uncomplicated influenza and expects to submit the peramivir NDA by the end of 2013.
On June 28, BioCryst completed a pre-NDA meeting with the FDA regarding peramivir. BioCryst reached agreement with FDA regarding all requirements for a complete NDA submission.
“We thank BARDA/HHS for its continued support of this program. This remaining funding is what we need to get peramivir to the finish line,” said Jon P. Stonehouse, President & Chief Executive Officer. “We are excited about the potential approval of peramivir as an i.v. treatment option that could benefit influenza patients in the United States.”
About Peramivir
Peramivir is a potent, intravenously administered investigational anti-viral agent that rapidly delivers high plasma concentrations to the sites of infection. Discovered by BioCryst, peramivir inhibits the interactions of influenza neuraminidase, an enzyme which is critical to the spread of influenza within a host. In laboratory tests, peramivir has shown activity against multiple influenza strains, including H7N9 and pandemic H1N1 swine flu viral strains. Peramivir is being developed under a $234.8 million contract from BARDA/HHS. In January 2010, Shionogi & Co., Ltd. launched intravenous peramivir in Japan under the name RAPIACTA® to treat patients with influenza and in August 2010, Green Cross Corporation announced that it had received marketing and manufacturing authorization for i.v. peramivir in Korea to treat patients with influenza A & B viruses, including H1N1 and avian influenza. For more information about peramivir please visit BioCryst’s Web site at http://www.biocryst.com/peramivir.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals designs, optimizes and develops novel small molecule drugs that block key enzymes involved in infectious and inflammatory diseases, with the goal of addressing unmet medical needs of patients and physicians. BioCryst currently has two late-stage development programs: peramivir, a viral neuraminidase inhibitor for the treatment of influenza, and ulodesine, a purine nucleoside phosphorylase (PNP) inhibitor for the treatment of gout. In addition, BioCryst has several early-stage programs: BCX4161 and a next generation oral inhibitor of plasma kallikrein for hereditary angioedema and BCX4430, a broad spectrum antiviral for hemorrhagic fevers. For more information, please visit the Company’s website at www.BioCryst.com.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause BioCryst’s actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: that the FDA may not provide regulatory approval for any use of peramivir or that the approval may be limited; that BARDA/HHS may further condition, reduce or eliminate future funding of the peramivir program; that BioCryst may never file an NDA for peramivir regulatory approval in any country; that the Company may not be able to access adequate capital to move peramivir forward; that the Company may not be able to retain its current pharmaceutical and biotechnology partners for further development of its product candidates or may not reach favorable agreements with potential pharmaceutical and biotechnology partners for further development of product candidates. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and current reports on Form 8-K, all of which identify important factors that could cause the actual results to differ materially from those contained in BioCryst’s projections and forward-looking statements.
(ALNY) Positive Top-Line Results in TTR-Mediated Amyloidosis
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today positive top-line results from its ongoing Phase I trial of ALN-TTRsc, a subcutaneously administered RNAi therapeutic targeting the transthyretin (TTR) gene for the treatment of TTR-mediated amyloidosis (ATTR). The company is reporting that ALN-TTRsc achieved robust and statistically significant (p<0.01) knockdown of serum TTR protein levels of greater than 80% in healthy volunteer subjects, in line with results for ALN-TTRsc previously reported in non-human primates. In addition, to date ALN-TTRsc was found to be generally safe and well tolerated. Dose escalation in this trial continues and results will be presented at the Annual Scientific Meeting of the Heart Failure Society of America (HFSA), being held September 22 – 25, 2013 in Orlando, Fla. These human study results are the first to be reported for Alnylam’s proprietary GalNAc-siRNA conjugate delivery platform, enabling subcutaneous dosing of RNAi therapeutics with a wide therapeutic index.
“These clinical results with ALN-TTRsc establish human translation for RNAi therapeutics that utilize our GalNAc-siRNA conjugate delivery platform. This platform enables subcutaneous dose administration with a wide therapeutic index and has now become our primary approach for development of RNAi therapeutics. As a result, we believe these data are very meaningful not only for the continued advancement of ALN-TTRsc, but also for the continued execution on our entire ‘Alnylam 5×15’ product strategy,” said John Maraganore, Ph.D., Chief Executive Officer of Alnylam. “Specifically, we are very excited to report top-line results from the study showing statistically significant knockdown of serum TTR to levels greater than 80% in treated subjects, results which are in line with our non-human primate experience. We look forward to continued advancement of our ALN-TTRsc program, including presentation of data from the Phase I trial at the HFSA meeting in September, start of a Phase II study in familial amyloidotic cardiomyopathy patients by the end of this year, and – assuming positive results – start of a pivotal Phase III trial for ALN-TTRsc in 2014.”
ATTR is caused by mutations in the TTR gene which cause abnormal amyloid protein deposits to accumulate in various tissues including peripheral nerves and heart, resulting in neuropathy and/or cardiomyopathy. ATTR represents a major unmet medical need with significant morbidity and mortality; familial amyloidotic polyneuropathy (FAP) affects approximately 10,000 people worldwide and familial amyloidotic cardiomyopathy (FAC) affects at least 40,000 people worldwide. ALN-TTRsc, which is being developed for the treatment of FAC, is a subcutaneously administered RNAi therapeutic that comprises an siRNA conjugated to a GalNAc ligand that enables receptor-mediated delivery to the liver. ALN-TTRsc is the first GalNAc-siRNA – and the first subcutaneously delivered – systemic RNAi therapeutic to enter clinical development stages. Alnylam is also developing ALN-TTR02, an intravenously administered RNAi therapeutic targeting TTR for the treatment of FAP patients with ATTR.
The ongoing Phase I trial of ALN-TTRsc is being conducted in the U.K. as a randomized, double-blind, placebo-controlled, single- and multi-dose, dose-escalation study, enrolling up to 40 healthy volunteer subjects. Subjects received single or multiple ascending subcutaneous doses of ALN-TTRsc ranging from 1.25 to 10 mg/kg. The primary objective of the study is to evaluate the safety and tolerability of single and multiple doses of subcutaneously administered ALN-TTRsc. Secondary objectives include assessment of clinical activity of the drug as measured by serum TTR levels. Upon completion of the Phase I trial, the company plans to start a Phase II clinical study of ALN-TTRsc in FAC patients in late 2013 and, assuming positive results, expects to start a pivotal Phase III trial for ALN-TTRsc in FAC patients in 2014.
Pre-clinical studies have shown that subcutaneous administration of ALN-TTRsc resulted in potent and sustained suppression of TTR. In non-human primates, ALN-TTRsc administration resulted in an approximately 80% reduction of TTR at doses as low as 2.5 mg/kg. In single- and multi-dose pre-clinical safety studies in rodents and non-human primates, ALN-TTRsc was found to be generally safe and well tolerated. Specifically, at doses as high as 300 mg/kg in non-human primates, ALN-TTRsc was well tolerated with no clinical signs, no adverse laboratory or histopathologic findings, no elevations in cytokines or complement, and no significant injection site reactions; these results demonstrate an approximately 100-fold therapeutic index for GalNAc-siRNA conjugates.
In 2012, Alnylam entered into an exclusive alliance with Genzyme, a Sanofi company, to develop and commercialize RNAi therapeutics, including ALN-TTR02 and ALN-TTRsc, for the treatment of ATTR in Japan and the broader Asian-Pacific region. Alnylam plans to develop and commercialize the ALN-TTR program in North and South America, Europe, and rest of the world.
Alnylam is hosting an R&D Day today from 8:30 a.m. – 12:00 p.m. ET at the Sofitel New York in New York City. Alnylam scientists and management will review progress with the company’s “Alnylam 5×15” product strategy for the development of RNAi therapeutics. The event will be webcast live on the News & Investors section of the company’s website, www.alnylam.com. An audio replay of the event will be available on the Alnylam website approximately 90 minutes after the event.
About Transthyretin-Mediated Amyloidosis
Transthyretin (TTR)-mediated amyloidosis (ATTR) is an inherited, progressively debilitating, and fatal disease caused by mutations in the TTR gene. TTR protein is produced primarily in the liver and is normally a carrier for retinol binding protein. Mutations in TTR cause abnormal amyloid proteins to accumulate and damage body organs and tissue, such as the peripheral nerves and heart, resulting in intractable peripheral sensory neuropathy, autonomic neuropathy, and/or cardiomyopathy. ATTR represents a major unmet medical need with significant morbidity and mortality; familial amyloidotic polyneuropathy (FAP) affects approximately 10,000 people worldwide and familial amyloidotic cardiomyopathy (FAC) affects at least 40,000 people worldwide. FAP patients have a life expectancy of five to 15 years from symptom onset, and the only treatment options for early stage disease are liver transplantation and tafamidis (approved in Europe). The mean survival for FAC patients is approximately 2.5 years, and there are no approved therapies. There is a significant need for novel therapeutics to treat patients who have inherited mutations in the TTR gene.
About GalNAc Conjugates
GalNAc-siRNA conjugates are a proprietary Alnylam delivery platform and are designed to achieve targeted delivery of RNAi therapeutics to hepatocytes through uptake by the asialoglycoprotein receptor. Research findings demonstrate potent and durable target gene silencing, as well as a wide therapeutic index, with subcutaneously administered GalNAc-siRNAs from multiple “Alnylam 5×15” programs.
About RNA Interference (RNAi)
RNAi (RNA interference) is a revolution in biology, representing a breakthrough in understanding how genes are turned on and off in cells, and a completely new approach to drug discovery and development. Its discovery has been heralded as “a major scientific breakthrough that happens once every decade or so,” and represents one of the most promising and rapidly advancing frontiers in biology and drug discovery today which was awarded the 2006 Nobel Prize for Physiology or Medicine. RNAi is a natural process of gene silencing that occurs in organisms ranging from plants to mammals. By harnessing the natural biological process of RNAi occurring in our cells, the creation of a major new class of medicines, known as RNAi therapeutics, is on the horizon. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam’s RNAi therapeutic platform, target the cause of diseases by potently silencing specific mRNAs, thereby preventing disease-causing proteins from being made. RNAi therapeutics have the potential to treat disease and help patients in a fundamentally new way.
About Alnylam Pharmaceuticals
Alnylam is a biopharmaceutical company developing novel therapeutics based on RNA interference, or RNAi. The company is leading the translation of RNAi as a new class of innovative medicines with a core focus on RNAi therapeutics toward genetically defined targets for the treatment of serious, life-threatening diseases with limited treatment options for patients and their caregivers. These include: ALN-TTR02, an intravenously delivered RNAi therapeutic targeting transthyretin (TTR) for the treatment of TTR-mediated amyloidosis (ATTR) in patients with familial amyloidotic polyneuropathy (FAP); ALN-TTRsc, a subcutaneously delivered RNAi therapeutic targeting TTR for the treatment of ATTR in patients with familial amyloidotic cardiomyopathy (FAC); ALN-AT3, an RNAi therapeutic targeting antithrombin (AT) for the treatment of hemophilia and rare bleeding disorders (RBD); ALN-AS1, an RNAi therapeutic targeting aminolevulinate synthase-1 (ALAS-1) for the treatment of acute intermittent porphyria (AIP); ALN-PCS, an RNAi therapeutic targeting PCSK9 for the treatment of hypercholesterolemia; ALN-TMP, an RNAi therapeutic targeting TMPRSS6 for the treatment of beta-thalassemia and iron-overload disorders; ALN-AAT, an RNAi therapeutic targeting alpha-1-antitrypsin (AAT) for the treatment of AAT deficiency liver disease; and ALN-CC5, an RNAi therapeutic targeting the C5 component of the complement pathway for the treatment of complement-mediated diseases, amongst other programs. As part of its “Alnylam 5×15TM” strategy, the company expects to have five RNAi therapeutic products for genetically defined diseases in clinical development, including programs in advanced stages, on its own or with a partner by the end of 2015. Alnylam has additional partnered programs in clinical or development stages, including ALN-RSV01 for the treatment of respiratory syncytial virus (RSV) infection and ALN-VSP for the treatment of liver cancers. The company’s leadership position on RNAi therapeutics and intellectual property have enabled it to form major alliances with leading companies including Merck, Medtronic, Novartis, Biogen Idec, Roche, Takeda, Kyowa Hakko Kirin, Cubist, Ascletis, Monsanto, Genzyme, and The Medicines Company. In addition, Alnylam holds an equity position in Regulus Therapeutics Inc., a company focused on discovery, development, and commercialization of microRNA therapeutics. Alnylam has also formed Alnylam Biotherapeutics, a division of the company focused on the development of RNAi technologies for applications in biologics manufacturing, including recombinant proteins and monoclonal antibodies. Alnylam’s VaxiRNA™ platform applies RNAi technology to improve the manufacturing processes for vaccines; GlaxoSmithKline is a collaborator in this effort. Alnylam scientists and collaborators have published their research on RNAi therapeutics in over 100 peer-reviewed papers, including many in the world’s top scientific journals such as Nature, Nature Medicine, Nature Biotechnology, and Cell. Founded in 2002, Alnylam maintains headquarters in Cambridge, Massachusetts. For more information, please visit www.alnylam.com.
About “Alnylam 5×15™”
The “Alnylam 5×15” strategy, launched in January 2011, establishes a path for development and commercialization of novel RNAi therapeutics toward genetically defined targets for the treatment of diseases with high unmet medical need. Products arising from this initiative share several key characteristics including: a genetically defined target and disease; the potential to have a major impact in a high unmet need population; the ability to leverage the existing Alnylam RNAi delivery platform; the opportunity to monitor an early biomarker in Phase I clinical trials for human proof of concept; and the existence of clinically relevant endpoints for the filing of a new drug application (NDA) with a focused patient database and possible accelerated paths for commercialization. By the end of 2015, the company expects to have five such RNAi therapeutic programs in clinical development, including programs in advanced stages, on its own or with a partner. The “Alnylam 5×15” programs include: ALN-TTR02, an intravenously delivered RNAi therapeutic targeting transthyretin (TTR) for the treatment of TTR-mediated amyloidosis (ATTR) in patients with familial amyloidotic polyneuropathy (FAP); ALN-TTRsc, a subcutaneously delivered RNAi therapeutic targeting TTR for the treatment of ATTR in patients with familial amyloidotic cardiomyopathy (FAC); ALN-AT3, an RNAi therapeutic targeting antithrombin (AT) for the treatment of hemophilia and rare bleeding disorders (RBD); ALN-AS1, an RNAi therapeutic targeting aminolevulinate synthase-1 (ALAS-1) for the treatment of acute intermittent porphyria (AIP); ALN-PCS, an RNAi therapeutic targeting PCSK9 for the treatment of hypercholesterolemia; ALN-TMP, an RNAi therapeutic targeting TMPRSS6 for the treatment of beta-thalassemia and iron-overload disorders; ALN-AAT, an RNAi therapeutic targeting alpha-1-antitrypsin (AAT) for the treatment of AAT deficiency liver disease; and ALN-CC5, an RNAi therapeutic targeting the C5 component of the complement pathway for the treatment of complement-mediated diseases, amongst other programs. Alnylam intends to focus on developing and commercializing certain programs from this product strategy itself in North and South America, Europe, and other parts of the world; these include ALN-TTR, ALN-AT3, and ALN-AS1; the company will seek global development and commercial alliances for other programs.
Alnylam Forward-Looking Statements
Various statements in this press release concerning Alnylam’s future expectations, plans and prospects, including without limitation, Alnylam’s expectations regarding its “Alnylam 5×15” product strategy, Alnylam’s views with respect to the potential for RNAi therapeutics, including ALN-TTRsc, its expectations regarding the reporting of data from its ALN-TTRsc clinical trials, its expectations with respect to the timing and success of its clinical trials for ALN-TTRsc, and its expectations regarding the potential market opportunity for ALN-TTRsc, 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, without limitation, Alnylam’s ability to discover and develop novel drug candidates and delivery approaches, successfully demonstrate the efficacy and safety of its drug candidates, including ALN-TTRsc, the pre-clinical and clinical results for its product candidates, which may not support further development of product candidates, actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials, obtaining, maintaining and protecting intellectual property, Alnylam’s ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties, obtaining regulatory approval for products, competition from others using technology similar to Alnylam’s and others developing products for similar uses, Alnylam’s ability to obtain additional funding to support its business activities and establish and maintain strategic business alliances and new business initiatives, Alnylam’s dependence on third parties for development, manufacture, marketing, sales and distribution of products, the outcome of litigation, and unexpected expenditures, as well as those risks more fully discussed in the “Risk Factors” filed with Alnylam’s current report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 7, 2013 and in other filings that Alnylam makes with the SEC. In addition, any forward-looking statements represent Alnylam’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Alnylam explicitly disclaims any obligation to update any forward-looking statements.
(PSIX) Announces Pricing of Public Offering
WOOD DALE, Ill., July 11, 2013 (GLOBE NEWSWIRE) — Power Solutions International, Inc. (Nasdaq:PSIX), a leader in the design, engineering and manufacture of emissions-certified alternative-fuel and conventional power systems, today announced the pricing of its underwritten public offering of 1,750,000 shares of its common stock at a price to the public of $35.00 per share. The Company is selling 1,050,000 shares of common stock, and certain selling stockholders are selling 700,000 shares of common stock in the offering. In addition, the selling stockholders have granted the underwriters an option to purchase up to an additional 255,000 shares of common stock in the aggregate at the public offering price, less the underwriting discount, to cover the over-allotment of shares. The offering is expected to close on or about July 16, 2013, subject to the satisfaction of customary closing conditions.
Craig-Hallum Capital Group LLC is acting as sole book-running manager of the offering, with Roth Capital Partners, LLC acting as co-lead manager.
The offering is being made only by means of a prospectus. Copies of the final prospectus related to the offering may be obtained from Craig-Hallum Capital Group LLC, 222 South Ninth Street, Suite 350, Minneapolis, MN 55402, Attention: Bart Federak, Phone 612-334-6357 / Fax 612-334-6348, Email: bart.federak@craig-hallum.com; or from Roth Capital Partners, LLC, 888 San Clemente Drive, Newport Beach, California 92660, Attention: Equity Capital Markets, Phone (800) 678-9147 / Fax (949) 720-7227.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or 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.
About Power Solutions International, Inc.
Power Solutions International, Inc. (PSI) is a leader in the design, engineering and manufacture of emissions-certified, alternative-fuel power systems. PSI provides integrated turnkey solutions to leading global original equipment manufacturers in the industrial and on-road markets. The company’s unique in-house design, prototyping, engineering and testing capacities allows PSI to customize clean, high-performance engines that run on a wide variety of fuels including natural gas, propane, biogas, diesel and gasoline.
PSI develops and delivers complete .97 to 22 liter power systems, including the new 8.8 liter engine aimed at the industrial and on-road markets including medium duty fleets, delivery trucks, school buses and garbage/refuse trucks. PSI power systems are currently used worldwide in power generators, forklifts, aerial lifts, and industrial sweepers, as well as in oil and gas, aircraft ground support, agricultural and construction equipment.
CONTACT: Power Solutions International, Inc. Dan Gorey Chief Financial Officer +1 (630) 451-2290 dan.gorey@psiengines.com
(RMTI) SFP Meets Primary/Secondary Endpoints in Kidney Disease Phase 3
WIXOM, MI — (Marketwired) — 07/11/13 — Rockwell Medical (NASDAQ: RMTI)
- In dialysis patients not receiving IV iron, SFP effectively delivers iron via dialysate and maintains hemoglobin without increasing stored iron (ferritin); strong safety data demonstrates no anaphylactic or hypersensitivity events and no increase in hypotension or infection
- Conference call to be held today, Thursday July 11, 2013 at 8:00am Eastern Time
Rockwell Medical (NASDAQ: RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis, today announced successful top-line results from the long-term CRUISE-1 Phase 3 efficacy study of SFP. SFP is the Company’s late-stage investigational iron-delivery drug for the treatment of iron deficiency in chronic kidney disease patients receiving hemodialysis. In the Phase 3 efficacy study, SFP met the primary endpoint, demonstrating a statistically significant mean change in hemoglobin from baseline to End-of-Treatment. Additionally, SFP met key secondary endpoints, including maintenance of hemoglobin, maintenance of reticulocyte hemoglobin, and increase in serum iron pre-to-post treatment without an increase in ferritin. This long-term study is the first of two identical Phase 3 efficacy studies to provide clinical data required for the Company to file a New Drug Application (NDA) with the U.S. FDA.
Rob Chioini, Founder, Chairman and CEO of Rockwell Medical stated, “We are thrilled with the successful results of this CRUISE-1 efficacy study. In addition to demonstrating statistical significance and meeting the primary efficacy endpoint, the data show that in place of IV iron, SFP is a safe and effective iron replacement therapy that consistently maintains hemoglobin levels without increasing iron stores. These successful results, coupled with the recent positive PRIME study data demonstrating SFP’s ability to significantly reduce ESA use, support our belief that SFP will set a new paradigm in iron therapy treatment for hemodialysis patients. We believe SFP is positioned to become the new standard of care in iron therapy. We anticipate confirmatory and successful results from the CRUISE-2 trial, which is nearing completion.”
Primary Efficacy Endpoint
The CRUISE-1 study successfully met its pre-defined primary efficacy endpoint, which was a change in hemoglobin from Baseline to End-of-Treatment between the SFP and placebo groups. The mean difference between SFP and placebo was 3.6 g/L (95% CI 0.8, 6.3) in favor of SFP, and was statistically significant (p=0.011).
At baseline the two groups had similar hemoglobin levels (109.6 g/L SFP and 109.0 g/L placebo). The mean adjusted change from baseline hemoglobin to the end of the randomized treatment period in the SFP group was 0.6 g/L (95% CI -1.7, 2.8). In the placebo group there was a statistically significant decline of -3.0 g/L (95% CI -5.3, -0.8).
Key Secondary Endpoints
The key secondary endpoints at End-of-Treatment showed statistically significant differences between the SFP and placebo groups, including the pre-dialysis reticulocyte hemoglobin (CHr) and serum ferritin. CHr, an early index and the best marker of iron-delivery to the bone marrow, was maintained at baseline levels in the SFP group during the randomized treatment, compared to a significant decrease in the placebo group. At End-of-Treatment, the difference between groups was a statistically significant 2.1% difference in favor of SFP (p < 0.001). Serum ferritin, a marker of tissue iron stores, declined by 14.7% from baseline in the SFP arm while the placebo group ferritin level declined by 28.2%. The difference between groups was statistically significant (p < 0.001). These results indicate that hemodialysate containing 2 µM SFP iron delivers sufficient iron to maintain erythropoiesis and does not lead to tissue iron overload.
Safety
Overall the adverse events reported were those that are expected in the chronic hemodialysis population. There were no differences in frequency or severity between the SFP and placebo groups with respect to AEs or serious adverse events. Importantly, the incidence of intradialytic hypotension, infections, and cardiac events in the SFP group was similar to or less than that observed in the placebo group. There were no events of anaphylaxis or hypersensitivity reported with dialysis administrations of SFP.
---------------------------------------------------------------------------- SFP N=149 Placebo N=151 Adverse Events N (%) N (%) ---------------------------------------------------------------------------- Procedural (Intradialytic) Hypotension 43 (28.9) 41 (27.2) ---------------------------------------------------------------------------- AVF complication 17 (11.4) 17 (11.3) ---------------------------------------------------------------------------- Hemodialysis induced Symptom 7 (4.7) 5 (3.3) ---------------------------------------------------------------------------- AVF Hemorrhage or Thrombosis 8 (5.4) 6 (4.0) ---------------------------------------------------------------------------- AVG complication or Thrombosis 6 (4.0) 4 (3.3) ---------------------------------------------------------------------------- Device Thrombosis 3 (2.0) 5 (3.3) ---------------------------------------------------------------------------- Infections 29 (19.5) 31 (20.5) ---------------------------------------------------------------------------- Cardiac Disorders 14 (9.4) 21 (13.9) ----------------------------------------------------------------------------
Dr. Raymond Pratt, Chief Medical Officer of Rockwell Medical, commented on the results, “We are extremely pleased to see such outstanding clinical results for safety and efficacy in a very well-designed and well-run Phase 3 study. We congratulate the investigators and our clinical team for their dedication and work. The successful achievement of meeting the CRUISE-1 primary efficacy endpoint with statistical significance confirms our belief that SFP, administered via dialysate, safely and effectively replaces the iron loss experienced by hemodialysis patients. The positive CHr and ferritin data demonstrate that iron from SFP is directed at erythropoiesis and is not increasing iron stores. The safety profile for SFP, which was similar to placebo treated patients, is excellent and to date we have not identified a single safety issue attributable to SFP. We expect that the CRUISE-2 study results will confirm CRUISE-1 data and we are working toward filing our NDA submission. We have great confidence in ultimately gaining FDA market approval for this unique iron treatment therapy.”
Dr. Ajay Gupta, Chief Scientific Officer of Rockwell Medical, added, “This successful CRUISE-1 study data confirm our belief that SFP is an extremely safe drug that consistently maintains hemoglobin and that can effectively replace the general need for IV iron administration in dialysis patients. This is the first demonstration of an iron therapy preventing the development of the iron deficient state and iron deficiency anemia in hemodialysis dependent CKD patients. The increasing safety concerns centered on IV iron, with tissue iron overload, infections, and anaphylactic reactions, highlight the importance of the strong safety profile of SFP in our large clinical program, comprising approximately 60,000 human doses of SFP iron. In contrast to the rapid bolus administration of IV iron, SFP delivers iron slowly and continuously in a physiologic manner during every hemodialysis session replacing dialytic iron loss. SFP has the potential to be the first and only iron product indicated for maintenance of hemoglobin and reducing ESA utilization, and we fully expect SFP to become the new standard of care for iron management in CKD-HD patients.”
Study Design
The CRUISE-1 study was a single-blind, placebo controlled, parallel group study comparing SFP (2µM [110 µg iron/L] delivered via hemodialysate concentrate) to placebo (standard hemodialysate concentrate). Adult patients with chronic kidney disease on regular hemodialysis, who were receiving stable doses of erythropoiesis stimulating agents (ESAs) and who were iron replete (as measured by serum transferrin saturation between 15 % to 40% and serum ferritin between 200 to 800 µg/L), were eligible for randomization. Patients who met the inclusion criteria entered a run-in period of 1 to 4 weeks. During the run-in, no study drug was administered, and no changes in the dose or route of administration of ESA were allowed. IV and oral iron products were not allowed from run-in through the end of randomized treatment.
Patients who continued to meet inclusion criteria during the run-in period were randomized 1:1 to receive either SFP via dialysate or placebo (standard dialysate) in a blinded manner for up to 48 weeks. Patients received the designated study drug at each dialysis session during the randomized treatment period. Hemoglobin, the measurement for the primary endpoint, was assessed weekly, along with iron parameters every two weeks. Randomized patients could remain in the study for up to 48 weeks
Over the course of the study patients were not permitted to have their ESA dose adjusted from baseline dose, and were not permitted IV or oral iron. The study design incorporated a pre-defined protocol to address safety criteria and removed patients prior to 48 weeks who met any of the following removal criteria: 1) a need to change ESA dose for low or high (< 90 or > 120 g/L) hemoglobin values, 2) rapidly rising hemoglobin defined as > 115 g/L and an increase of 10 g/L over 4 weeks, or 3) serum ferritin < 100 µg/L. By withholding iron and not allowing ESA dose adjustment during the study period, the study was designed for removal of the majority of patients prior to end of study while demonstrating a statistically significant change in hemoglobin from Baseline to End-of-Treatment between the SFP and placebo groups. All patient hemoglobin values, no matter what time point patients were removed from the study due to the pre-defined protocol safety criteria, were included in the primary endpoint calculation. Patients removed from the study were transitioned into an open-label extension period. Patients could also be withdrawn from the randomized treatment period for transfusions, adverse events, protocol violations or by request of the patient or investigator.
The primary study population was the modified Intent-to-Treat (mITT) population, defined as all patients who were randomized, and received at least one dose of study drug, and had at least one post-baseline hemoglobin value during the randomized treatment period.
The primary outcome measure for this study was the mean change in hemoglobin level from baseline to the End-of-Treatment. End-of-Treatment was defined as the average of the hemoglobin levels during the last 1/6th of the randomized treatment period of each patient. A minimum of at least two on-study hemoglobin values were necessary for inclusion in the analysis. The primary outcome statistic was provided by an analysis of covariance (ANCOVA) for the change from baseline hemoglobin between treatment groups, using baseline hemoglobin value as a covariate.
Secondary endpoints included the changes from baseline in pre-dialysis reticulocyte hemoglobin (CHr), ferritin and serum iron parameters. Safety endpoints included all treatment emergent adverse events (TEAEs), serious adverse events (TESAEs), intradialytic hypotension, cardiac events and anaphylactic/hypersensitivity events.
Baseline Characteristics
At baseline, the two treatment groups were well balanced with respect to age (mean 58 years), gender (32% female, 68% male), race (55% white, 32% black and 13% other) and ethnicity. There were 152 patients randomized to the SFP treatment arm and 153 patients were randomly assigned to receive placebo. The mean duration of participation in the randomized treatment period was approximately 6 months (23 weeks). As the pre-defined safety criteria protocol specified, there were a number of patients removed prior to end of study for reasons of safety/anemia management. Due to pre-defined reasons of safety/anemia management (see pre-defined safety criteria under Study Design, above), 69 patients were removed in the SFP arm and 83 were removed in placebo. Due to anemia related protocol violations (IV iron or ESA given), 19 patients were removed from the study in the SFP arm and 22 in placebo. 1 patient was removed in the SFP arm and 7 patients in placebo due to blood transfusions. Other reasons for early termination were balanced between the groups.
Conference call information
Rockwell will host a conference call today, July 11, 2013 at 8:00am Eastern Time to present the top-line results from this Phase 3 CRUISE-1 study for SFP. The conference call can be accessed by dialing 1-877-383-7438 (U.S.), 1-678-894-3975 (outside the U.S.), call-in ID: 16758531. The call will be simultaneously webcast at http://ir.rockwellmed.com/events.cfm and will be available for replay at this link for 14 days.
About SFP
SFP is a unique iron compound that is delivered to the hemodialysis patient via dialysate, replacing the 5-7 mg of iron lost during a dialysis treatment. SFP is introduced into the sodium bicarbonate concentrate that subsequently is mixed into dialysate. Once in the dialysate, SFP crosses the dialyzer membrane and enters the bloodstream where it immediately binds to apo-transferrin and is taken to the bone marrow, similar to how dietary iron is processed in the human body. In completed clinical trials to date, SFP has demonstrated that it can safely deliver iron and maintain hemoglobin levels while decreasing ESA use, without increasing iron stores.
About Rockwell Medical
Rockwell Medical is a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis.
Rockwell’s lead drug candidate in late-stage clinical development is for the treatment of iron deficiency in dialysis patients and is called Soluble Ferric Pyrophosphate (SFP). SFP delivers iron to the bone marrow of dialysis patients in a non-invasive, physiologic manner via dialysate during their regular dialysis treatment. In completed clinical trials to date, SFP has demonstrated that it can safely deliver sufficient iron to the bone marrow. SFP is nearing completion of its Phase 3 clinical study program (CRUISE-1 and CRUISE-2) and is expected to address an estimated $600M U.S. market.
Rockwell is preparing to launch its FDA approved generic drug Calcitriol, to treat secondary hyperparathyroidism in dialysis patients. Calcitriol (active vitamin D injection) is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy. Rockwell intends to launch Calcitriol once it receives FDA manufacturing approval, addressing an estimated $350M U.S. market.
Rockwell is also an established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad. As one of the two major suppliers in the U.S., Rockwell’s products are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient’s bloodstream. Rockwell has three manufacturing/distribution facilities located in the U.S. and its operating infrastructure is a ready-made sales and distribution channel that is able to provide seamless integration into the commercial market for its drug products, Calcitriol and SFP upon FDA market approval.
Rockwell’s exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are intended to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience. Rockwell Medical is developing a pipeline of drug therapies, including extensions of SFP for indications outside of hemodialysis. Please visit www.rockwellmed.com for more information. For a demonstration of SFP’s unique mechanism of action in delivering iron via dialysate, please view the animation video at http://www.rockwellmed.com/collateral/documents/english-us/mode-of-action.html.
Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, Rockwell’s intention to launch Calcitriol and SFP following FDA approval. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Rockwell Medical believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in Rockwell Medical’s SEC filings. Thus, actual results could be materially different. Rockwell Medical expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.
Michael Rice
Investor Relations
646-597-6979
David Connolly
Media Contact
(LBIX) Announces Q1 Results
Q1 Net Income $689,000 or $0.24 per share ($0.22 fully diluted)
Q1 EBITDAS $1,173,000 or $0.40 per Share ($0.37 fully diluted)
Quarterly Revenues increase 3.7%
VANCOUVER, British Columbia, July 11, 2013 (GLOBE NEWSWIRE) — Leading Brands, Inc. (Nasdaq:LBIX), North America’s only fully integrated healthy branded beverage company, announces results for its first quarter of fiscal 2013, which ended May 31, 2013. All financial amounts are denominated in Canadian dollars, with all financial figures rounded to the nearest $000.
Q1 2013 net income was $689,000 or $0.24 per share ($0.22 fully diluted) versus net income of $411,000 or $0.13 per share in the same quarter of fiscal 2012.
Q1 2013 net income before stock based compensation (SBC) was $729,000 or $0.25 per share ($0.23) fully diluted) versus $457,000 or $0.14 per share in the same quarter last year.
Q1 2013 EBITDAS (Earnings Before Interest, Depreciation, Amortization and SBC) was $1,173,000 or $0.40 per share ($0.37 fully diluted), versus $796,000 or $0.25 per share during the same period last year.
Non-GAAP Net Income before SBC is determined as follows: | ||
Q1 2013 | Q1 2012 | |
Net Income | $ 689,000 | $ 411,000 |
Add Back SBC | 40,000 | 46,000 |
Net income before SBC | $ 729,000 | $ 457,000 |
Non-GAAP Net Income per share before SBC is determined as follows: | ||
Q1 2013 | Q1 2012 | |
Net Income | $ 0.24 | $ 0.13 |
Add Back SBC | 0.01 | 0.01 |
Net income before SBC – Basic | $ 0.25 | $ 0.14 |
Pro-forma results for EBITDAS, as defined below, are determined as follows: | ||
Q1 2013 | Q1 2012 | |
Net Income | $ 689,000 | $ 411,000 |
Add Back: | ||
Interest | 3,000 | 3,000 |
Depreciation and amortization | 182,000 | 158,000 |
Non-cash stock based compensation | 40,000 | 46,000 |
Non-cash income tax expense | 259,000 | 178,000 |
Total Add Backs | 484,000 | 385,000 |
EBITDAS | $ 1,173,000 | $ 796,000 |
EBITDAS per share reconciles to earnings per share as follows: | ||
Q1 2013 | Q1 2012 | |
Net Income | $ 0.24 | $ 0.13 |
Add Back: | ||
Interest | — | — |
Depreciation and Amortization | 0.06 | 0.05 |
Non-cash stock based compensation | 0.01 | 0.01 |
Non-cash income tax expense | 0.09 | 0.06 |
Total Add Backs | 0.16 | 0.12 |
EBITDAS | $ 0.40 | $ 0.25 |
Gross profit margin for the quarter was 47.0% representing a significant increase over the same quarter of last year.
Gross revenue for Q1 2013 was $5,123,000, an increase of 3.7% over $4,940,000 in the comparative period of last year. The increase in revenue was principally due to a rise in demand for co-packing services although sales of the Company’s new Happy Water® brand rose significantly as well.
Discounts, rebates and slotting fees were $206,000 in Q1 2013, a decrease of $70,000 compared to the same period of the prior year as a result of lower discounts on the Company’s licensed brands. SG&A expenses were $1,148,000 in Q1 of fiscal 2013, versus $1,081,000 in Q1 of the previous year.
As at May 31, 2013 the Company had cash and available credit totaling approximately $1,647,000.
During Q1 2013 the Company repurchased an additional 18,996 shares of its common stock at an average price of USD$4.56 per share, pursuant to its share repurchase program. As at May 31, 2013 the Company had outstanding 2,942,349 common shares. The Company’s Board of Directors has increased the amount of the repurchase program by an additional USD$500,000 as it believes that the Company’s common shares remain undervalued. Following this increase, the share repurchase program now has approximately USD$730,000 remaining.
The repurchase program will continue concurrent with this announcement and expire upon the expenditure of the committed amount. It is subject to applicable laws, the insider-trading windows imposed by the Company’s trading policy and may be suspended or terminated at any time by the Company’s Board, without prior notice. Under the program, the Company may, but is not required to, purchase its shares from time to time through open market or privately negotiated transactions, as market and business conditions permit. Any repurchased shares will be returned to authorized but unissued shares of its common stock.
AGM
The Company’s Annual General Meeting was held on July 10, 2013. All motions put to the Meeting, being those described in the Notice of Meeting and supporting materials mailed to shareholders, were passed with significantly greater percentages than required. Ralph McRae and Darryl Eddy were re-elected as directors of the Company, each for a three year term.
About Leading Brands, Inc.
Leading Brands, Inc. (Nasdaq:LBIX) is North America’s only fully integrated healthy beverage company. Leading Brands creates, designs, bottles, distributes and markets its own proprietary premium beverage brands via its unique Integrated Distribution System (IDS)™ which involves the Company finding the best and most cost-effective route to market. The Company strives to use the best natural ingredients hence its mantra: Better Ingredients – Better Brands.
Non-GAAP Measures
Any non-GAAP financial measures referenced in this release do not have any standardized meaning prescribed by GAAP and are therefore unlikely to be comparable to similar measures presented by other issuers.
EBITDAS is a non-GAAP financial measure. EBITDAS is defined as net income (loss) before income taxes, interest expense, depreciation and amortization and stock-based compensation. EBITDAS should not be construed as a substitute for net income (as determined in accordance with GAAP) for the purpose of analyzing operating performance, as EBITDAS is not defined by GAAP. However, the Company regards EBITDAS as a complement to net income and income before taxes.
Forward Looking Statements
Certain information contained in this press release includes forward-looking statements. Words such as “believe”, “expect,” “will,” or comparable terms, are intended to identify forward-looking statements concerning the Company’s expectations, beliefs, intentions, plans, objectives, future events or performance and other developments. All forward-looking statements included in this press release are based on information available to the Company on the date hereof. Such statements speak only as of the date hereof. Important factors that could cause actual results to differ materially from the Company’s estimations and projections are disclosed in the Company’s securities filings and include, but are not limited to, the following: general economic conditions, weather conditions, changing beverage consumption trends, pricing, availability of raw materials, economic uncertainties (including currency exchange rates), government regulation, managing and maintaining growth, the effect of adverse publicity, litigation, competition and other risk factors described from time to time in securities reports filed by Leading Brands, Inc. For all such forward-looking statements, we claim the safe harbor for forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
Better Ingredients | Better Brands™
©2013 Leading Brands, Inc.
This news release is available at www.LBIX.com
(table follows)
LEADING BRANDS, INC. | ||
INTERIM CONSOLIDATED STATEMENT OF INCOME | ||
(UNAUDITED) | ||
(EXPRESSED IN CANADIAN DOLLARS) | ||
Three months ended | ||
May 31, 2013 | May 31, 2012 | |
Gross revenue | $ 5,123,363 | $ 4,939,938 |
Less: Discounts, rebates and slotting fees | (206,482) | (275,827) |
Net Revenue | 4,916,881 | 4,664,111 |
Cost of sales | 2,608,141 | 2,787,039 |
Operations, selling, general & administration expenses | 1,148,192 | 1,081,478 |
Depreciation of property, plant and equipment | 181,695 | 158,498 |
Interest on long-term debt | 3,240 | 5,243 |
Interest income | — | (2,636) |
Foreign exchange loss | 248 | 8,477 |
Change in fair value of derivative liability | 27,447 | 18,003 |
Loss on disposal of assets | 332 | 18,140 |
3,969,295 | 4,074,242 | |
_______________ | ____________ | |
Net income before taxes | 947,586 | 589,869 |
Income tax expense | 258,852 | 178,390 |
Net income and other comprehensive income | $ 688,734 | $ 411,479 |
Earnings per share | ||
Basic income per share | $ 0.24 | $ 0.13 |
Weighted average number of shares – basic | 2,930,220 | 3,236,668 |
Diluted income per share | $ 0.22 | $ 0.12 |
Weighted average number of shares – diluted | 3,183,776 | 3,509,326 |
CONTACT: Leading Brands, Inc. Tel: (604) 685-5200 Email: info@LBIX.com
(WAVX) CEO Sprague to Present Paper on Network Modernization in India
LEE, MA — (Marketwired) — 07/11/13 — Wave Systems Corp. (NASDAQ: WAVX), the Trusted Computing Company, today announced that CEO Steven Sprague will present the paper, “Modernize the Network: Device Identity Network Meets Enterprise Needs” at the Data Security Council (DSCI) “Best Practices Meet” in Chennai, India on Friday, July 12.
An annual event, “Best Practices Meet” gathers leading members of the security community to discuss the changing dynamics of the threat landscape and evaluate defense architectures to counter advanced persistent threats. The event is coordinated by IEEE in association with DSCI.
Who: Mr. Sprague, CEO of Wave Systems
What: The paper outlines how a stronger foundation for network security can be built on the identity of the device, as opposed to the user. Because network access is granted based on user identity, it leaves corporate networks vulnerable to advanced persistent threats and socially engineered hacks. The cable and cellular phone industries have successfully adopted this model, and are now less vulnerable to attack.
Where: Mr. Sprague will appear via video conference at DSCI “Best Practices Meet” at the Hyatt Regency 365 Anna Salai, Teynampet, Chennai
When: Friday, July 12, 3:30 p.m. (local time in Chennai)
More information on the agenda and track session can be found at http://www.dsci.in/events/about/1336
The paper will be among several presented before an esteemed group of judges, including Ponnavaikko Murugesan, Head, IEEE India Council; Deepak Garg, Director, IEEE India Council; B M Mehtre, Associate Professor, IDRBT; Vishal Salvi, CISO, HDFC Bank; Maria Bellarmine, CISO, Tech Mahindra; Sunil Varkey, CISO, Wipro; Roop Chandar, Director Global Operations, HCL.
DSCI is a focal body on data protection in India, set up as an independent self-regulatory organization by NASSCOM®, to promote data protection, develop security and privacy best practices & standards and encourage the Indian industries to implement the same.
Wave is represented locally by Sasi Bhushan of Infodat Technologies (+91 40 44886999 X 989) and Vinod Kumar of Satcom Infotech +91-98200-35781. Both Infodat Technologies and Satcom Infotech are Wave Gold Distributor Partners.
About Wave Systems
Wave Systems Corp. (NASDAQ: WAVX) reduces the complexity, cost and uncertainty of data protection by starting inside the device. Unlike other vendors who try to secure information by adding layers of software for security, Wave leverages the security capabilities built directly into endpoint computing platforms themselves. Wave has been a foremost expert on this growing trend, leading the way with first-to-market solutions and helping shape standards through its work as a board member for the Trusted Computing Group.
Safe Harbor for Forward-Looking Statements
This press release may contain forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), including all statements that are not statements of historical fact regarding the intent, belief or current expectations of the company, its directors or its officers with respect to, among other things: (i) the company’s financing plans; (ii) trends affecting the company’s financial condition or results of operations; (iii) the company’s growth strategy and operating strategy; and (iv) the declaration and payment of dividends. The words “may,” “would,” “will,” “expect,” “estimate,” “anticipate,” “believe,” “intend” and similar expressions and variations thereof are intended to identify forward-looking statements. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the company’s ability to control, and that actual results may differ materially from those projected in the forward-looking statements as a result of various factors. Wave assumes no duty to and does not undertake to update forward-looking statements.
All brands are the property of their respective owners.
Company:
Pratap S. Kesarkar
Wave Systems Corp.
609-750-6869 (O)
india@wave.com
Investor Relations:
David Collins
Eric Lentini
212-924-9800
wavx@catalyst-ir.com
(MDRX) Q2 Bookings To Exceed $200M, Demonstrating Growth
Company expects 2Q 2013 backlog of approximately $3.1 billion, a Company record Second quarter 2013 financial results to be released on August 8
CHICAGO, July 10, 2013 /PRNewswire/ — Allscripts (NASDAQ: MDRX) announced preliminary sales results for the second quarter of 2013. Allscripts expects bookings to exceed $200 million for the three months ended June 30, 2013. This compares positively with bookings of approximately $194 million for the second quarter of 2012 and approximately $178 million for the first quarter of 2013, respectively.
In addition, the Company expects total contract backlog as of June 30, 2013 to approximate $3.1 billion, or approximately 13 percent quarter-over-quarter growth, a Company record. Preliminary second quarter contract backlog includes the five-year extension for Managed IT Services with North Shore-LIJ Health System, as well as several other client extensions signed during the second quarter. The contract renewal at North Shore-LIJ Health System did not contribute to the bookings result for the second quarter.
“I am pleased to report tangible progress with several of our strategic initiatives,” said Paul Black, Allscripts President and Chief Executive Officer. “Our focus on client obligations is beginning to deliver results as we see improving confidence from both inside and outside the Allscripts client base. We are seeing a healthy mix of new agreements with existing clients as well as new client wins, growing our recurring revenue backlog as well as bookings. We look forward to discussing our progress in further detail on August 8th.”
Earnings Call Details
Allscripts will report its financial results for the three months ended June 30, 2013, after the stock market closes on Thursday, August 8, 2013. Allscripts management will host a conference call and webcast to discuss the company’s earnings and other information at 4:30 p.m. Eastern Daylight Time that same day. The press release also will be available on the company’s website at http://investor.allscripts.com.
To listen to the conference call, participants may log onto http://www.allscripts.com/. Participants also may access the conference call by dialing (877) 303-0543 (toll free in the U.S.) or (973) 935-8787 (international) and requesting Conference ID #13179595.
A replay of the call will be available two hours after the conclusion of the call, for a period of two weeks, at http://www.allscripts.com/ or by calling (855) 859-2056 or (404) 537-3406 – Conference ID #13179595.
The presentations may be accessed live or as archived files at http://investor.allscripts.com.
About Allscripts
Allscripts (NASDAQ: MDRX) delivers the insights that healthcare providers require to generate world-class outcomes. The company’s Electronic Health Record, practice management and other clinical, revenue cycle, connectivity and information solutions create a Connected Community of Health™ for physicians, hospitals and post-acute organizations. To learn more about Allscripts, please visit www.allscripts.com, Twitter, YouTube and It Takes A Community: The Allscripts Blog.
© 2013 Allscripts Healthcare, LLC. All Rights Reserved.
Allscripts, the Allscripts logo, and other Allscripts marks are either registered trademarks or trademarks of Allscripts Healthcare, LLC in the United States and/or other countries. All other trademarks are the property of their respective owners.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the federal securities laws. Statements regarding future events or developments, our future performance, as well as management’s expectations, beliefs, intentions, plans, estimates or projections relating to the future are forward-looking statements with the meaning of these laws. These forward-looking statements are subject to a number of risks and uncertainties, some of which are outlined below. As a result, no assurances can be given that any of the events anticipated by the forward-looking statements will transpire or occur, or if any of them do so, what impact they will have on our results of operations or financial condition. Such risks, uncertainties and other factors include, among other things: the possibility that our current initiatives focused on product delivery, client experience, streamlining our cost structure, and financial performance may not be successful, which could result in declining demand for our products and services, including attrition among our existing customer base; the impact of the realignment of our sales and services organization; potential difficulties or delays in achieving platform and product integration and the connection and movement of data among hospitals, physicians, patients and others; the risks that we will not achieve the strategic benefits of the merger with Eclipsys Corporation (Eclipsys) or our acquisition of dbMotion, Ltd. (dbMotion), or that the Allscripts products will not be integrated successfully with the Eclipsys and dbMotion products; competition within the industries in which we operate, including the risk that existing clients will switch to products of competitors; failure to maintain interoperability certification pursuant to the Health Information Technology for Economic and Clinical Health Act (HITECH), with resulting increases in development and other costs for us and possibly putting us at a competitive disadvantage in the marketplace; the volume and timing of systems sales and installations, the length of sales cycles and the installation process and the possibility that our products will not achieve or sustain market acceptance; the timing, cost and success or failure of new product and service introductions, development and product upgrade releases; any costs or customer losses we may incur relating to the standardization of our small office electronic health record and practice management systems that could adversely affect our results of operations; competitive pressures including product offerings, pricing and promotional activities; our ability to establish and maintain strategic relationships; errors or similar problems in our software products or other product quality issues; the outcome of any legal proceeding that has been or may be instituted against us and others; compliance obligations under new and existing laws, regulations and industry initiatives, including new regulations relating to HIPAA/HITECH, increasing enforcement activity in respect of anti-bribery, fraud and abuse, privacy, and similar laws, and future changes in laws or regulations in the healthcare industry, including possible regulation of our software by the U.S. Food and Drug Administration; the possibility of product-related liabilities; our ability to attract and retain qualified personnel; the continued implementation and ongoing acceptance of the electronic record provisions of the American Recovery and Reinvestment Act of 2009, as well as elements of the Patient Protection and Affordable Care Act (aka health reform) which pertain to healthcare IT adoption, including uncertainty related to changes in reimbursement methodology and the shift to pay-for-outcomes; maintaining our intellectual property rights and litigation involving intellectual property rights; legislative, regulatory and economic developments; risks related to third-party suppliers and our ability to obtain, use or successfully integrate third-party licensed technology; breach of data security by third parties and unauthorized access to patient health information by third parties resulting in enforcement actions, fines and other litigation. See our Annual Report on Form 10-K/10K-A for 2012 and other public filings with the SEC for a further discussion of these and other risks and uncertainties applicable to our business. The statements herein speak only as of their date and we undertake no duty to update any forward-looking statement whether as a result of new information, future events or changes in expectations.
(GIG) to Announce Second Quarter Fiscal Year 2013 Financial Results
GigOptix, Inc. (NYSE MKT: GIG), a supplier of advanced semiconductor and optical communications components, today announced that it will hold a conference call to discuss its financial results for the second quarter of fiscal year 2013, which ended June 30, 2013, on Monday, August 5, 2013.
Date: Monday, August 5, 2013
Time: 5:00 p.m. ET/2:00 p.m. PT
Conference Call Number: (800) 901-5213
International Call Number: (617) 786-2962
Passcode: 34132933
Replay Number: (888) 286-8010
International Call Number: (617) 801-6888
Passcode: 93960694
Duration: Through August 12, 2013
A webcast of the conference call will be broadcast live over the Internet and can be accessed in the Investor Relations section of the Company’s website at http://ir.gigoptix.com.
About GigOptix, Inc.
GigOptix is a leading fabless supplier of semiconductor and optical components that enable high speed information streaming that address emerging high growth opportunities in the communications, industrial, defense and avionics industries. The Company offers a broad portfolio of high performance MMIC solutions that enable next generation wireless microwave systems up to 90GHz and drivers, TIAs and TFPSTM optical modulators for 40Gbps and 100Gbps fiber-optic telecommunications and data-communications networks. GigOptix also offers a wide range of digital and mixed-signal ASIC solutions and enables product lifetime extension through its GigOptix Sunset Rescue Program.
(PCYC) New Drug Application for Ibrutinib Submitted to the U.S. FDA
SUNNYVALE, Calif., July 10, 2013 /PRNewswire/ — Pharmacyclics, Inc. (Nasdaq: PCYC) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational oral Bruton’s tyrosine kinase (BTK) inhibitor, ibrutinib, for two relapsed/refractory B-cell malignancy indications: mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). The submission was based on data from Phase II studies in patients with relapsed/refractory MCL and in patients with relapsed/refractory CLL/SLL. With this submission, Pharmacyclics is also requesting Priority Review. Pharmacyclics is jointly developing ibrutinib with Janssen.
The NDA submission follows the receipt of a Breakthrough Therapy Designation from the FDA in February 2013 for ibrutinib as a monotherapy for the treatment of patients with relapsed/refractory MCL, and receipt of a second Breakthrough Therapy Designation for the treatment of patients with CLL/SLL with deletion of the short arm of chromosome 17 (del 17p). Further information on the implications of this filing for potential commercialization will be provided subsequent to the FDA rendering a decision on the filing.
“We are very excited having achieved this major milestone. This first NDA for ibrutinib was made possible in record time because of the continuous support and consultations we received from the FDA,” said Dr. Urte Gayko, Senior Vice President of Global Regulatory Affairs, Pharmacyclics. “We look forward to continuing to work with the FDA as they review the application for ibrutinib through the new Breakthrough Therapy Designation process.”
“These past months have been enormously active and productive for Pharmacyclics and our ibrutinib partner, Janssen. We received our first of three Breakthrough Therapy Designations just this past February and since then published various clinical results in patients with CLL del17p and also in patients with Waldenstroms; in April we completed enrollment of our first Phase III study; last month, results of two of our trials were published in the prestigious New England Journal of Medicine and today Pharmacyclics announced the filing of its first NDA for ibrutinib with the Food and Drug Administration,” said Bob Duggan CEO and Chairman of Pharmacyclics. “Thus far, more than 1600 patients have been treated in our studies with ibrutinib and we are making excellent progress in the development and preparation for commercialization of this investigational drug. As of today, we have initiated 7 Phase III studies together with our partner Janssen and have currently registered with the US National Institute of Health 31 clinical trials using ibrutinib. It is Pharmacyclics’s goal to advance science and drug development in the hopes of making a significant difference for the betterment of patients with serious unmet healthcare needs, and with the announcement today we have accomplished an important milestone in our timeless journey.”
About CLL / SLL
CLL, a B-cell malignancy, is a slow-growing blood cancer that starts in the white blood cells (lymphocytes), most commonly from B-cells. CLL is the second most common adult leukemia. Approximately 15,680 patients in the US are diagnosed each year with CLL. The prevalence of CLL is approximately 113,000 in the U.S. It is a chronic disease of the elderly with a five-year survival of approximately 82 percent.1 Patients commonly receive multiple lines of treatment over the course of their disease. When cancer cells are located mostly in the lymph nodes, the disease is called SLL. CLL and SLL are considered to be different manifestations of the same underlying disease; they share similarities in signs and symptoms, genetic features, disease progression and treatment.
In CLL, the genetic mutation del 17p occurs when the short arm of chromosome 17 is missing. Del 17p CLL is associated with abnormalities of a key tumor suppressor gene, TP53, which results in poor response to chemoimmunotherapy and worse treatment outcomes. It occurs in about seven percent of treatment naïve CLL patients, with approximately 20-40 percent of relapsed/refractory patients harboring the mutation.
About Mantle Cell Lymphoma
MCL is a B-cell malignancy, an aggressive type of B-cell non-Hodgkin lymphoma (NHL) that usually occurs in older adults.2 The disease typically begins in the lymph nodes, but can spread to other tissues, such as bone marrow, liver, and spleen3. Patients typically survive an average of five years.4 In the U.S., there are approximately 5,000 new cases of MCL each year.3
About Ibrutinib
Ibrutinib is an investigational agent designed to provide potent and sustained inhibition of an enzyme called Bruton’s tyrosine kinase (BTK). BTK is a key mediator of at least three critical B-cell pro-survival mechanisms occurring in parallel – regulation of apoptosis, adhesion, and cell migration and homing. Through these multiple signals, BTK regulation helps to direct malignant B-cells to lymphoid tissues, thus allowing access to a micro-environment necessary for survival.
The effectiveness of ibrutinib alone or in combination with other treatments is being studied in several B-cell malignancies, including chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, Waldenström’s macroglobulinemia and multiple myeloma. To date, 7 Phase III trials have been initiated with ibrutinib and a total of 31 trials are currently registered on www.clinicaltrials.gov. Janssen and Pharmacyclics entered a collaboration and license agreement in December 2011 to co-develop and co-commercialize ibrutinib.
About Pharmacyclics
Pharmacyclics® is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative small-molecule drugs for the treatment of cancer and immune mediated diseases. Our mission and goal is to build a viable biopharmaceutical company that designs, develops and commercializes novel therapies intended to improve quality of life, increase duration of life and resolve serious unmet medical healthcare needs; and to identify promising product candidates based on scientific development and administrational expertise, develop our products in a rapid, cost-efficient manner and pursue commercialization and/or development partners when and where appropriate.
Presently, Pharmacyclics has three product candidates in clinical development and several preclinical molecules in lead optimization. The company is committed to high standards of ethics, scientific rigor, and operational efficiency as it moves each of these programs to viable commercialization.
Pharmacyclics is headquartered in Sunnyvale, California and is listed on NASDAQ under the symbol PCYC. To learn more about how Pharmacyclics advances science to improve human healthcare visit us at http://www.pharmacyclics.com.
NOTE: This announcement may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements, among others, relating to our future capital requirements, including our expected liquidity position and timing of the receipt of certain milestone payments, and the sufficiency of our current assets to meet these requirements, our future results of operations, our expectations for and timing of ongoing or future clinical trials and regulatory approvals for any of our product candidates, and our plans, objectives, expectations and intentions. Because these statements apply to future events, they are subject to risks and uncertainties. When used in this announcement, the words “anticipate”, “believe”, “estimate”, “expect”, “expectation”, “goal”, “should”, “would”, “project”, “plan”, “predict”, “intend”, “target” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements are based on information currently available to us and are subject to a number of risks, uncertainties and other factors that could cause our actual results, performance, expected liquidity or achievements to differ materially from those projected in, or implied by, these forward-looking statements. Factors that may cause such a difference include, without limitation, our need for substantial additional financing and the availability and terms of any such financing, the safety and/or efficacy results of clinical trials of our product candidates, our failure to obtain regulatory approvals or comply with ongoing governmental regulation, our ability to commercialize, manufacture and achieve market acceptance of any of our product candidates, for which we rely heavily on collaboration with third parties, and our ability to protect and enforce our intellectual property rights and to operate without infringing upon the proprietary rights of third parties. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, performance or achievements and no assurance can be given that the actual results will be consistent with these forward-looking statements. For more information about the risks and uncertainties that may affect our results, please see the Risk Factors section of our filings with the Securities and Exchange Commission, including our transition report on Form 10-K for the six month period ended December 31, 2012 and quarterly reports on Form 10-Q. We do not intend to update any of the forward-looking statements after the date of this announcement to conform these statements to actual results, to changes in management’s expectations or otherwise, except as may be required by law.
1 Cancer.net. “Leukemia – Chronic Lymphocytic – CLL”. http://www.cancer.net/cancer-types/leukemia-chronic-lymphocytic-cll/statistics. Accessed June 2013.
2 Cancer.net. “Lymphoma – Non-Hodgkin”. http://www.cancer.net/cancer-types/lymphoma-non-hodgkin/subtypes. Accessed April 2013.
3 Know Cancer. “Mantle Cell Lymphoma”. Available at: http://www.knowcancer.com/oncology/mantle-cell-lymphoma/. Accessed April 2013.
4 Geisler, C. (2010) “Front-line treatment of mantle cell lymphoma.” Haematologica, 95:8:1241-1243. Available at: http://www.haematologica.org/content/95/8/1241.full
(BMJ) Reports First Quarter Comparable Store Sales Increase of 9%
Birks & Mayors Inc. (NYSE MKT LLC: BMJ) (the “Company”) announced today that net sales during the 13 weeks ended June 29, 2013 were $70.1 million, representing an increase of $1.3 million, or 2%, compared to net sales of $68.8 million during the first quarter of fiscal 2013. Comparable store sales increased 9% during the first quarter (comparable store sales include stores open in both the current and prior period and are expressed at a constant exchange rate). The net increase in sales of $1.3 million was primarily driven by the 9% increase in comparable store sales, partially offset by the $2.1 million of lower sales associated with the closure of seven underperforming stores, $1.7 million of decreased revenues related to non-retail activities (corporate sales, refining activities and internet sales) and $0.6 million of lower sales related to translating the Company’s Canadian sales into U.S. dollars due to the weaker Canadian dollar. The comparable store sales increase reflects a 5% increase in sales from the stores in Canada while comparable store sales in the U.S. increased by 15%.
About Birks & Mayors Inc.
Birks & Mayors is a leading operator of luxury jewelry stores in the United States and Canada. As of June 29, 2013, the Company operated 29 stores under the Birks Brand in most major metropolitan markets in Canada, 20 stores in Florida and Georgia under the Mayors brand, one store under the Rolex brand name and two retail locations in Calgary and Vancouver under the Brinkhaus brand. Birks was founded in 1879 and developed over the years into Canada’s premier retailer, designer and manufacturer of fine jewelry, timepieces, sterling and plated silverware and gifts. Mayors was founded in 1910 and has maintained the intimacy of a family-owned boutique while becoming renowned for its fine jewelry, timepieces, giftware and service. Additional information can be found on Birks & Mayors web site, www.birksandmayors.com
(INO) Publishes Phase 1 CELLECTRA® Data in HIV Vaccine Human Study
Next-generation HIV vaccine achieves seven-fold increase (7% to 52%) in response rate of CD8 T-cells when delivered with electroporation; robust CD4 or CD8 T-cell responses observed in 89% of subjects Results published in peer-reviewed Journal of Infectious Diseases
BLUE BELL, Pa., July 10, 2013 /PRNewswire/ — Inovio Pharmaceuticals, Inc. (NYSE MKT: INO) announced today the peer-reviewed publication of results from two phase I trials (HVTN 070 and HVTN 080) of its PENNVAX®-B preventive HIV DNA vaccine delivered with a DNA adjuvant and with or without Inovio’s proprietary CELLECTRA® electroporation delivery device. The studies were conducted by the HIV Vaccine Trials Network (HVTN). Inovio’s HIV DNA vaccine together with the CELLECTRA device significantly increased the number of responders producing robust and durable CD4 and CD8 T-cell responses in humans. The observation of robust T-cell responses against distinct targeted diseases generated by different Inovio SynCon® DNA vaccines delivered using CELLECTRA electroporation technology have now been published in two respected peer-reviewed journals. These results are compelling because T-cells are considered critical to fighting cancers and chronic infectious diseases.
While Inovio previously released preliminary data from these two trials, this comparison and durability data was published in the peer-reviewed Journal of Infectious Diseases in the article, “Safety and comparative immunogenicity of an HIV-1 DNA vaccine in combination with plasmid IL-12 and impact of intramuscular electroporation for delivery.” The lead author was Dr. Spyros Kalams, who is Associate Professor of Medicine, Vanderbilt University Medical Center and principal investigator of Vanderbilt’s HIV Vaccine Trials Unit for both clinical studies.
Robust T-cell responses were generated in 89% of the subjects that received three vaccinations of PENNVAX-B, which consists of 1 mg of each of three DNA plasmids (encoding for HIV gag, pol, and env proteins) along with 1 mg of IL-12 DNA plasmid, followed by intramuscular electroporation with Inovio’s CELLECTRA device. Three or four vaccinations with a 2 mg dose of each PENNVAX-B plasmid plus 1.5 mg of IL-12 DNA generated fewer responses when delivered without electroporation.
Comparative T-Cell Response Rates: | ||
PENNVAX-B Plus DNA IL-12 With and Without CELLECTRA Electroporation (EP) | ||
Regimen | CD4 | CD8 |
Half dose, 3 vaccinations, with EP | 80.8% (21/26) | 51.9% (14/27) |
Full dose, 3 vaccinations, without EP | 19.2% (5/26) | 6.9% (2/29) |
Full dose, 4 vaccinations, without EP | 40.7% (11/27) | 3.6% (1/28) |
Notably, using only half the vaccine dose, and only three doses as compared to four, CELLECTRA electroporation generated a 45% point increase (7% to 52%) in the generation of CD8 T-cells compared to the subjects that received a full dose without electroporation. In the three-vaccination regimen with electroporation, 88.9% (24/27) of subjects developed a robust CD4 or CD8 response. Six months after vaccination, T-cell response rates remained strong and persistent in the subjects that received only three doses delivered by CELLECTRA EP. Of 24 positive CD4 or CD8 T-cell responders following the third and last vaccination in month 3, 79% (19/24) showed persistent CD4 or CD8 T-cell responses at month 9. There were no safety issues observed when Inovio’s DNA vaccine for HIV was co-administered with IL-12 DNA and delivered using electroporation with CELLECTRA.
CD4 and CD8 T-cells are both important in cellular immunity, however, CD8 T-cells are considered especially integral to fighting cancers and chronic infectious diseases. Achieving a robust CD8 T-cell response in a significant number of patients, i.e. a significant response rate, has been a particular challenge for HIV researchers. In this study, PENNVAX-B generated CD8 T-cell responses with significant magnitude (as measured by the validated HVTN assay).
In other study arms that did not achieve statistical significance, the use of IL-12 DNA appeared to positively impact T-cell response rates. The increased response rate only occurred when IL-12 DNA was delivered with electroporation. This effect may be further investigated in future studies of Inovio DNA vaccines delivered with electroporation.
Dr. J. Joseph Kim, Inovio’s President and CEO, said, “This is the second major scientific journal to publish clinical papers demonstrating our best-in-class T-cell responses from two of Inovio’s product candidates in two different disease indications.
“This proof-of-concept data highlights not only the robust HIV-specific T-cell production achievable with next-generation vaccine technology, but clearly defines in a human comparison study the very significant impact of our CELLECTRA electroporation technology in increasing targeted immune responses – with a dose sparing benefit and excellent safety outcomes to date. The difference in T-cell generation is striking and will benefit the further development of our transformative DNA vaccines to treat and prevent HIV infection and other diseases. We have incorporated this knowledge from the single-clade PENNVAX-B program into the design of our multi-clade PENNVAX®-GP vaccine, which is now our lead preventive and therapeutic vaccine that broadly targets global HIV strains, and look forward to initiating our first human study of this vaccine later this year. PENNVAX-GP was developed through a $25 million contract with the NIAID; the clinical study of PENNVAX-GP will also be conducted by the HVTN.”
Inovio’s patented CELLECTRA electroporation delivery technology uses controlled, millisecond electrical pulses to create temporary pores in the cell membrane and allow significant cellular uptake of a synthetic DNA vaccine previously injected into muscle or skin. This technique has been shown to increase gene expression of the encoded “antigen” by as much as 1000-fold compared to vaccination without electroporation.
Inovio’s cutting-edge DNA and electroporation technology also avoids issues that have plagued some other vaccine platforms: for example, researchers have observed that some vector-based vaccines may be associated with the lessening of immune responses driven by vaccination.
The two HIV phase I trials, HVTN 070 (without electroporation; n=120 patients); and 080 (with electroporation; n=48 patients); were multicenter, randomized, clinical trials. The studies were sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), an agency of the National Institutes of Health, and conducted by the NIAID-funded HIV Vaccine Trials Network (HVTN) at several clinical sites.
About the HVTN
The HIV Vaccine Trials Network (HVTN), headquartered at Fred Hutchinson Cancer Research Center in Seattle, Wash., is an international collaboration of scientists and educators searching for an effective and safe HIV vaccine. The HVTN’s mission is to facilitate the process of testing preventive vaccines against HIV/AIDS. The HVTN conducts all phases of clinical trials, from evaluating experimental vaccines for safety and the ability to stimulate immune responses, to testing vaccine efficacy. Support for the HVTN comes from the National Institute of Allergy and Infectious Diseases (NIAID) of the U.S. National Institutes of Health (NIH). The Network’s HIV Vaccine Trial Units are located at leading research institutions in 27 cities on four continents. Internationally renowned HIV vaccine and prevention researchers lead the units.
About Inovio Pharmaceuticals, Inc.
Inovio is revolutionizing vaccines to prevent and treat today’s cancers and challenging infectious diseases. Its synthetic consensus design approach is intended to help the immune system identify and fight cancer cells or multiple unmatched strains of a mutating virus. These proprietary synthetic vaccines, in combination with Inovio’s electroporation delivery, have in humans generated best-in-class immune responses with a favorable safety profile. Inovio’s lead vaccine, a therapeutic against HPV-caused diseases, is in phase II. Other phase I and preclinical programs focus on HIV, influenza, malaria and hepatitis C virus. Partners and collaborators include the University of Pennsylvania, Merck, National Cancer Institute, U.S. Military HIV Research Program, NIH, HIV Vaccines Trial Network, University of Southampton, US Dept. of Homeland Security, University of Manitoba and PATH Malaria Vaccine Initiative. More information is available at www.inovio.com.
This press release contains certain forward-looking statements relating to our business, including our plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines and our capital resources. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials and product development programs (including, but not limited to, the fact that pre-clinical and clinical results referenced in this release may not be indicative of results achievable in other trials or for other indications, that the studies or trials may not be successful or achieve the results desired, that pre-clinical studies and clinical trials may not commence or be completed in the time periods anticipated, that results from one study may not necessarily be reflected or supported by the results of other similar studies and that results from an animal study may not be indicative of results achievable in human studies), the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA vaccines, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by the company or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that the company and its collaborators hope to develop, evaluation of potential opportunities, issues involving product liability, issues involving patents and whether they or licenses to them will provide the company with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether the company can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of the company’s technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2012, our Form 10-Q for the quarter ended March 31, 2013, and other regulatory filings from time to time. There can be no assurance that any product in Inovio’s pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proven accurate.
CONTACTS:
Investors: Bernie Hertel, Inovio Pharmaceuticals, 858-410-3101, bhertel@inovio.com
Media: Jeff Richardson, Inovio Pharmaceuticals, 267-440-4211, jrichardson@inovio.com
(AMS) Announces 2014 Gamma Knife Reimbursement Rates Proposed by CMS
AMERICAN SHARED HOSPITAL SERVICES (NYSE MKT:AMS), a leading provider of turnkey technology solutions for advanced radiosurgical and radiation therapy services, announced today that the Centers for Medicare and Medicaid Services (CMS) has posted the proposed rule for Medicare’s hospital outpatient prospective payment system for calendar year 2014. Within this proposed rule, CMS proposes updates for the delivery codes used for stereotactic radiosurgery (SRS), including Gamma Knife services.
CMS proposes to reimburse hospitals for a complete course of treatment comprised of a single session of SRS at $8,576 in 2014. This payment level would apply to single session treatment for all forms of SRS – Cobalt-60 SRS (Gamma Knife), robotic linear accelerator (LINAC) SRS or non-robotic LINAC SRS. By comparison, effective April 1, 2013, the Gamma Knife was reimbursed by CMS at $3,300 and during the period January 1, 2013 to March 31, 2013 at $7,910. This CMS proposed reimbursement rate is subject to comments from interested parties, and could change. Final CMS reimbursement rates are anticipated to be issued in fall 2013.
About AMS
American Shared Hospital Services provides turnkey technology solutions for advanced radiosurgical and radiation therapy services. AMS is the world leader in providing Gamma Knife radiosurgery equipment, a non-invasive treatment for malignant and benign brain tumors, vascular malformations and trigeminal neuralgia (facial pain). The Company also offers the latest IGRT and IMRT systems, as well as its proprietary Operating Room for the 21st CenturySM concept. AMS owns common stock in Mevion Medical Systems, Inc., developer of the compact MEVION S250™ Proton Therapy System.
Safe Harbor Statement
This press release may be deemed to contain certain forward-looking statements with respect to the financial condition, results of operations and future plans of American Shared Hospital Services, which involve risks and uncertainties including, but not limited to, the risks of the Gamma Knife and radiation therapy businesses, the risks of developing The Operating Room for the 21st Century program, and the risks of investing in a development-stage company, Mevion Medical Systems, Inc., without a proven product. Further information on potential factors that could affect the financial condition, results of operations and future plans of American Shared Hospital Services is included in the filings of the Company with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2012, the Quarterly Report on Form 10-Q for the quarter ended on March 31, 2012, and the definitive Proxy Statement for the Annual Meeting of Shareholders held on June 7, 2012.
(HITK) Reports Sales of $58.5M for the Fourth Quarter
Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) today reported results for the fourth quarter and year ended April 30, 2013.
- Net sales of $58.5 million for the fourth quarter compared to $61.3 million for the same prior year period
- GAAP loss of $4.6 million or $0.34 per diluted share for the fourth quarter
- Adjusted non-GAAP net income of $6.9 million or $0.50 per diluted share for the fourth quarter
- Net sales of $232.4 million for the fiscal year compared to $230.0 million for the same prior year period
- GAAP income of $16.3 million or $1.19 per diluted share for the fiscal year
- Adjusted non-GAAP net income of $31.0 million or $2.28 per diluted share for the fiscal year
Fourth Quarter | Fiscal Year | |||||||||||||||||||||
2013 | 2012 | 2013 | 2012 | |||||||||||||||||||
Net sales | $ | 58,473,000 | $ | 61,292,000 | $ | 232,384,000 | $ | 230,003,000 | ||||||||||||||
GAAP net income | $ | (4,617,000 | ) | $ | 9,989,000 | $ | 16,251,000 | $ | 48,351,000 | |||||||||||||
Adjusted non-GAAP net income | $ | 6,868,000 | $ | 11,033,000 | $ | 31,049,000 | $ | 51,796,000 | ||||||||||||||
GAAP Diluted EPS | $ | (0.34 | ) | $ | 0.73 | $ | 1.19 | $ | 3.59 | |||||||||||||
Adjusted non-GAAP Diluted EPS | $ | 0.50 | $ | 0.81 | $ | 2.28 | $ | 3.85 |
(see Table I for reconciliation to GAAP numbers)
Fourth Quarter Results
For the three months ended April 30, 2013, the Company reported net sales of $58,473,000, a decrease of 5% from $61,292,000 for the same period last year.
During the quarter ended April 30, 2013, net sales of generic pharmaceutical products were $48,906,000, a decrease of 7% compared to $52,699,000 for the same fiscal 2012 period. The primary reason for the change was a decrease in sales of Fluticasone Propionate nasal spray. Sales of Fluticasone Propionate nasal spray totaled $19,600,000, down from $28,400,000 in the same fiscal 2012 period due to lower average prices. New product launches such as Nystatin oral suspension, Lidocaine 5% ointment, Levetiracetam oral solution, and Paregoric partially offset this decline in sales.
Sales for the Health Care Products division (“HCP”), which markets the Company’s branded OTC products, decreased 7% to $4,912,000 for the three months ended April 30, 2013 compared to $5,265,000 for the same fiscal period in the prior year. The decrease was primarily due to lower sales of Diabetic Tussin® which was partially offset by an increase in sales of MagOx®.
Sales for ECR Pharmaceuticals (“ECR”), which markets the Company’s branded prescription products, were $4,655,000 for the three months ended April 30, 2013, up 40% from $3,328,000 for the same period in the prior year. The increase was due to increased sales of TussiCaps®, which was acquired in fiscal 2012. Higher sales of Bupap® also contributed to this increase in ECR sales for the quarter.
Cost of goods sold increased to $31,182,000 for the three months ended April 30, 2013 from $29,461,000, and increased as a percentage of sales to 53% from 48% of sales. The increase in cost of goods sold as a percentage of net sales is primarily due to pricing declines for Fluticasone Propionate nasal spray. This trend was partially offset by launches of new generic products with above average margins and increased sales of higher margin products in the ECR subsidiary.
Selling, general and administrative expenses increased to $14,700,000 from $13,731,000, a 7% increase compared to the same fiscal 2012 period. The increase was primarily due to additional selling and marketing expenses in the ECR subsidiary. As a percentage of sales, SG&A increased to 25% from 23% for the three months ended April 30, 2013.
Amortization expense for the quarter ended April 30, 2013 was $1,606,000, a slight decrease from $1,618,000 for the comparable fiscal 2012 period.
For the three months ended April 30, 2013, Research and Development costs increased by 5% to $3,552,000 from $3,372,000 for the comparable fiscal 2012 period as a result of increased spending on internal projects for the generic division, which include five projects that require clinical trials. Clinical trials for two of these projects were ongoing during the quarter.
In the fourth quarter of 2013, the Company established a $15,500,000 settlement and loss contingency accrual to cover potential settlement or other outcomes in connection with the investigation by the Texas Health and Human Services Commission relating to the submission of price information. Additionally, the Company established a $700,000 accrual for the settlement of a class action lawsuit relating to the advertising of Nasal Ease®.
The Company reported adjusted non-GAAP quarterly net income of $6,868,000 or $0.50 per fully diluted share for the three months ended April 30, 2013, compared to adjusted non-GAAP net income of $11,033,000 or $0.81 per fully diluted share for the same period in the prior year.
Full Year Results
For the fiscal year ended April 30, 2013, the Company reported net sales of $232,384,000, an increase of 1% from $230,003,000 for the same period last year.
Sales of generic pharmaceutical products were $196,262,000, a decrease of 1% compared to $197,877,000 for the prior year. The decrease was primarily due to pricing declines of Fluticasone Propionate nasal spray. Sales of Fluticasone Propionate nasal spray decreased to $86,100,000 for the current fiscal year versus $99,400,000 in the previous fiscal year as the Company sold more units at a lower average price. The Company benefited from recent product launches such as Nystatin oral suspension, Lidocaine 5% ointment, Levetiracetam oral solution, and Paregoric which helped offset lower sales of Fluticasone.
Sales for the HCP division, which markets the Company’s branded OTC products, increased 3% to $17,700,000 for the fiscal year ended April 30, 2013 compared to $17,234,000 for the prior year. Stronger sales of Mag-Ox® led the increase in addition to sales of Sinus Buster®, which was acquired in the prior year.
ECR, which markets the Company’s branded prescription products, contributed $18,422,000 in sales for the full fiscal year, up 24% from $14,892,000 for the fiscal year ended April 30, 2012. The increase was due to higher sales of TussiCaps®, which was acquired in fiscal 2012. Increased sales of Bupap® and DexPak® also contributed to this increase in ECR sales for the fiscal year.
Cost of goods sold as a percentage of sales was 50% for the year ended April 30, 2013 compared to 44% for the year ended April 30, 2012. Pricing declines for Fluticasone Propionate nasal spray were partially offset by launches of new generic products with above average margins as well as increased sales in the higher margin ECR subsidiary.
Selling, general and administrative expenses increased to $53,575,000 from $44,698,000 primarily due to an increase of $4,428,000 in selling, marketing and severance costs at the ECR subsidiary as the Company restructured its sales organization. Additionally, advertising expense increased to $10,603,000 in fiscal 2013 from $8,864,000 in fiscal 2012 primarily to support the re-launch of Nasal Ease® and the newly acquired Sinus Buster® brand in the HCP division.
Amortization expense increased to $6,742,000 from $5,341,000, a 26% increase compared to the same fiscal 2012 period. The increase was due to intangible asset purchases over the last fiscal year which includes TussiCaps® and Sinus Buster®.
Research and Development costs increased by 41% to $17,331,000 from $12,256,000 as the Company increased spending on internal projects for the generic division. Additionally, the Company increased expenditures on five projects requiring clinical trials, four of which it has undertaken with partners. Clinical trials for three of these projects were ongoing during the year.
Royalty income decreased to $1,789,000 from $3,000,000 primarily because royalties on sales of certain divested products came to an end in June 2012.
In the fourth quarter of 2013, the Company established a $15,500,000 settlement and loss contingency accrual to cover potential settlement or other outcomes in connection with the investigation by the Texas Health and Human Services Commission relating to the submission of price information. Additionally, the Company established a $700,000 accrual for the settlement of a class action lawsuit relating to the advertising of Nasal Ease®.
Adjusted non-GAAP net income decreased to $31,049,000 or $2.28 per fully diluted share in fiscal 2013 compared to adjusted non-GAAP net income of $51,796,000 or $3.85 per fully diluted share for the prior year.
David Seltzer, President and CEO, commented: “The Company showed growth while facing several challenges along the way. Pricing of Fluticasone Nasal Spray, our best selling product saw steeper price declines than we expected throughout the fiscal year. However we continue to reduce our costs to partially offset this pricing decline. In addition, we had some one-time expenses associated with restructuring the ECR sales force under new leadership of Dr. Cameron Durrant. In our Health Care Products division, we spent more heavily on advertising to promote consumer products Nasal Ease® and Sinus Buster®, which we acquired last year. We believe that the investment we made in each of our branded divisions will enable them to grow and become more profitable. The increase in research and development spending in our generic division enabled us to build a pipeline of products developed in house and some recently licensed products which will drive our future growth.”
Non-GAAP Financial Measures
The Company is disclosing non-GAAP financial measures when providing financial results. Primarily due to settlements and loss contingency accruals, the Company believes that an evaluation of its ongoing operations (and comparisons of its current operations with historical and future operations) would be difficult if the disclosure of its financial results were limited to financial measures prepared only in accordance with accounting principles generally accepted in the U.S. (“GAAP”). In addition to disclosing its financial results determined in accordance with GAAP, the Company is disclosing certain non-GAAP results that exclude items such as amortization expense and other costs related to settlements and loss contingency accruals in order to supplement investors’ and other readers’ understanding and assessment of the Company’s financial performance, because the Company’s management uses these measures internally for forecasting, budgeting and measuring its operating performance. Whenever the Company uses such a non-GAAP measure, it will provide a reconciliation of non-GAAP financial measures to the most closely applicable GAAP financial measure. Investors and other readers are encouraged to review the related GAAP financial measures and the reconciliation of non-GAAP measures to their most closely applicable GAAP measure set forth below and should consider non-GAAP measures only as a supplement to, not as a substitute for or as a superior measure to, measures of financial performance prepared in accordance with GAAP.
Conference Call Information
The Company will hold a conference call to discuss its financial results today, July 9, 2013, at 10 a.m. Eastern Time.
To access the conference call, dial toll free 877-280-4953, or 857-244-7310 for international callers, five minutes before the conference. The passcode of the conference call is 15156675.
A replay of the conference call will be available after 12:00 p.m. on July 9, 2013, for one week by calling toll free 888-286-8010, or 617-801-6888 for international callers. The passcode for the replay is 38645450. Additionally, the conference call will be available on the Hi-Tech Pharmacal Investor Relations web page at www.hitechpharm.com.
Other Information
The following table shows Hi-Tech’s current R&D pipeline:
(Dollars in Billions) | |||||||||||||||||||||
Hi-Tech | Partnered | Total | |||||||||||||||||||
Products | # | Market | # | Market | # | Market | |||||||||||||||
At FDA | 14 | $ | 1.0 | 4 | $ | 1.6 | 18 | $ | 2.6 | ||||||||||||
Development | 21 | $ | 2.5 | 4 | $ | 1.4 | 25 | $ | 3.9 |
The pipeline includes sterile ophthalmic products, controlled substances, topicals, oral solutions and suspensions and solid dosage forms.
Hi-Tech is a specialty pharmaceutical company developing, manufacturing and marketing generic and branded prescription and OTC products. The Company specializes in difficult to manufacture liquid and semi-solid dosage forms and produces a range of sterile ophthalmic, otic and inhalation products. The Company’s Health Care Products division is a leading developer and marketer of OTC products for the diabetes marketplace. Hi-Tech’s ECR Pharmaceuticals subsidiary markets branded prescription products.
This press release contains certain future projections and forward-looking statements (statements which are not historical facts) with respect to the anticipated future performance of Hi-Tech made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such future projections and forward-looking statements are not assurances, promises or guarantees and investors are cautioned that all future projections and forward-looking statements involve significant business, economic and competitive risks and uncertainties, many of which are beyond Hi-Tech’s ability to control or estimate precisely, including, but not limited to, the impact of competitive products and pricing, product demand and market acceptance, new product development, the regulatory environment, including without limitation, reliance on key strategic alliances, availability of raw materials, fluctuations in operating results, loss of customers or employees, the possibility that legal proceedings may be instituted against Hi-Tech and other results and other risks detailed from time to time in Hi-Tech’s filings with the Securities and Exchange Commission. The actual results will vary from the projected results and such variations may be material. These statements are based on management’s current expectations and assumptions concerning the future performance of Hi-Tech and are naturally subject to uncertainty and changes in circumstances. No representations or warranties are made as to the accuracy or completeness of any of the information contained herein, including, but not limited to, any assumptions or projections contained herein or forward-looking statements based thereon. We caution you not to place undue reliance upon any such forward-looking statements which speak only as of the date made, except to the extent specifically dated as of an earlier date. Hi-Tech is under no obligation, and expressly disclaims any such obligation, to update, alter or correct any inaccuracies herein, whether as a result of new information, future events or otherwise.
Fiscal Year Ended April 30, | Three Months Ended April 30, | ||||||||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||||||||
Net sales | $ | 232,384,000 | $ | 230,003,000 | $ | 58,473,000 | $ | 61,292,000 | |||||||||||||
Cost of goods sold | 117,304,000 | 100,804,000 | 31,182,000 | 29,461,000 | |||||||||||||||||
Gross profit | 115,080,000 | 129,199,000 | 27,291,000 | 31,831,000 | |||||||||||||||||
Costs and expenses: | |||||||||||||||||||||
Selling, general and administrative expense | 53,575,000 | 44,698,000 | 14,700,000 | 13,731,000 | |||||||||||||||||
Amortization expense | 6,742,000 | 5,341,000 | 1,606,000 | 1,618,000 | |||||||||||||||||
Research and product development costs | 17,331,000 | 12,256,000 | 3,552,000 | 3,372,000 | |||||||||||||||||
Royalty income | (1,789,000 | ) | (3,000,000 | ) | (386,000 | ) | (707,000 | ) | |||||||||||||
Contract research (income) | (102,000 | ) | (428,000 | ) | (100,000 | ) | (202,000 | ) | |||||||||||||
Settlements and loss contingencies | 16,200,000 | — | 16,200,000 | — | |||||||||||||||||
Interest expense | 541,000 | 410,000 | 100,000 | 163,000 | |||||||||||||||||
Interest (income) and other | (291,000 | ) | (887,000 | ) | (108,000 | ) | (191,000 | ) | |||||||||||||
Total | $ | 92,207,000 | $ | 58,390,000 | $ | 35,564,000 | $ | 17,784,000 | |||||||||||||
Income (loss) before provision for income taxes | 22,873,000 | 70,809,000 | (8,273,000 | ) | 14,047,000 | ||||||||||||||||
Provision for income tax expense (benefit) | 6,622,000 | 22,458,000 | (3,656,000 | ) | 4,058,000 | ||||||||||||||||
Net income (loss) | $ | 16,251,000 | $ | 48,351,000 | $ | (4,617,000 | ) | $ | 9,989,000 | ||||||||||||
Basic earnings (loss) per share | $ | 1.22 | $ | 3.75 | $ | (0.34 | ) | $ | 0.77 | ||||||||||||
Diluted earnings (loss) per share | $ | 1.19 | $ | 3.59 | $ | (0.34 | ) | $ | 0.73 | ||||||||||||
Weighted average common shares outstanding,basic | 13,302,000 | 12,878,000 | 13,571,000 | 13,049,000 | |||||||||||||||||
Effect of potential common shares | 345,000 | 573,000 | — | 629,000 | |||||||||||||||||
Weighted average common shares outstanding,diluted | 13,647,000 | 13,451,000 | 13,571,000 | 13,678,000 | |||||||||||||||||
Table IHi-Tech Pharmacal Co., Inc.
Reconciliation of Non-GAAP Measures |
|||||||||||||||||||||||||||||||
Three Months Ended April 30, | |||||||||||||||||||||||||||||||
2013 | 2012 | ||||||||||||||||||||||||||||||
GAAP | Non-GAAP Adjustments | Non-GAAP As Adjusted | GAAP | Non-GAAP Adjustments | Non-GAAPAs Adjusted | ||||||||||||||||||||||||||
Net sales | $ | 58,473,000 | $ | — | $ | 58,473,000 | $ | 61,292,000 | $ | — | $ | 61,292,000 | |||||||||||||||||||
Cost of goods sold | 31,182,000 | — | 31,182,000 | 29,461,000 | — | 29,461,000 | |||||||||||||||||||||||||
Gross profit | 27,291,000 | — | 27,291,000 | 31,831,000 | — | 31,831,000 | |||||||||||||||||||||||||
Costs and expenses: | |||||||||||||||||||||||||||||||
Selling, general andadministrative expense | 14,700,000 | — | 14,700,000 | 13,731,000 | — | 13,731,000 | |||||||||||||||||||||||||
Amortization expense | 1,606,000 | 1,606,000(a | ) | — | 1,618,000 | 1,618,000(a | ) | — | |||||||||||||||||||||||
Research and productdevelopment costs | 3,552,000 | — | 3,552,000 | 3,372,000 | — | 3,372,000 | |||||||||||||||||||||||||
Royalty income | (386,000 | ) | — | (386,000 | ) | (707,000 | ) | — | (707,000 | ) | |||||||||||||||||||||
Contract research (income) | (100,000 | ) | — | (100,000 | ) | (202,000 | ) | — | (202,000 | ) | |||||||||||||||||||||
Settlements and losscontingencies | 16,200,000 | 16,200,000(b | ) | — | — | — | — | ||||||||||||||||||||||||
Interest expense | 100,000 | — | 100,000 | 163,000 | — | 163,000 | |||||||||||||||||||||||||
Interest (income) andother | (108,000 | ) | — | (108,000 | ) | (191,000 | ) | — | (191,000 | ) | |||||||||||||||||||||
Total | $ | 35,564,000 | $ | 17,806,000 | $ | 17,758,000 | $ | 17,784,000 | $ | 1,618,000 | $ | 16,166,000 | |||||||||||||||||||
Income (loss) beforeprovision for income taxes | (8,273,000 | ) | (17,806,000 | ) | 9,533,000 | 14,047,000 | (1,618,000 | ) | 15,665,000 | ||||||||||||||||||||||
Provision for incometax expense (benefit) | (3,656,000 | ) | (6,321,000 | )(c) | 2,665,000 | 4,058,000 | (574,000 | )(c) | 4,632,000 | ||||||||||||||||||||||
Net income (loss) | $ | (4,617,000 | ) | $ | (11,485,000 | ) | $ | 6,868,000 | $ | 9,989,000 | $ | (1,044,000 | ) | $ | 11,033,000 | ||||||||||||||||
Basic earnings (loss)per share | $ | (0.34 | ) | $ | 0.51 | $ | 0.77 | $ | 0.85 | ||||||||||||||||||||||
Diluted earnings (loss)per share | $ | (0.34 | ) | $ | 0.50 | $ | 0.73 | $ | 0.81 | ||||||||||||||||||||||
Weighted average commonshares outstanding, basic | 13,571,000 | 13,571,000 | 13,049,000 | 13,049,000 | |||||||||||||||||||||||||||
Effect of potential common shares | — | 183,000 | 629,000 | 629,000 | |||||||||||||||||||||||||||
Weighted average commonshares outstanding, diluted | 13,571,000 | 13,754,000 | 13,678,000 | 13,678,000 | |||||||||||||||||||||||||||
Fiscal Year Ended April 30, | |||||||||||||||||||||||||||||||
2013 | 2012 | ||||||||||||||||||||||||||||||
GAAP | Non-GAAP Adjustments | Non-GAAPAs Adjusted | GAAP | Non-GAAP Adjustments | Non-GAAPAs Adjusted | ||||||||||||||||||||||||||
Net sales | $ | 232,384,000 | $ | — | $ | 232,384,000 | $ | 230,003,000 | $ | — | $ | 230,003,000 | |||||||||||||||||||
Cost of goods sold | 117,304,000 | — | 117,304,000 | 100,804,000 | — | 100,804,000 | |||||||||||||||||||||||||
Gross profit | 115,080,000 | — | 115,080,000 | 129,199,000 | — | 129,199,000 | |||||||||||||||||||||||||
Costs and expenses: | |||||||||||||||||||||||||||||||
Selling, general andadministrative expense | 53,575,000 | — | 53,575,000 | 44,698,000 | — | 44,698,000 | |||||||||||||||||||||||||
Amortization expense | 6,742,000 | 6,742,000(a | ) | — | 5,341,000 | 5,341,000(a | ) | — | |||||||||||||||||||||||
Research and productdevelopment costs | 17,331,000 | — | 17,331,000 | 12,256,000 | — | 12,256,000 | |||||||||||||||||||||||||
Royalty income | (1,789,000 | ) | — | (1,789,000 | ) | (3,000,000 | ) | — | (3,000,000 | ) | |||||||||||||||||||||
Contract research(income) | (102,000 | ) | — | (102,000 | ) | (428,000 | ) | — | (428,000 | ) | |||||||||||||||||||||
Settlements and losscontingencies | 16,200,000 | 16,200,000(b | ) | — | — | — | — | ||||||||||||||||||||||||
Interest expense | 541,000 | — | 541,000 | 410,000 | — | 410,000 | |||||||||||||||||||||||||
Interest (income) and other | (291,000 | ) | — | (291,000 | ) | (887,000 | ) | — | (887,000 | ) | |||||||||||||||||||||
Total | $ | 92,207,000 | $ | 22,942,000 | $ | 69,265,000 | $ | 58,390,000 | $ | 5,341,000 | $ | 53,049,000 | |||||||||||||||||||
Income (loss) beforeprovision for income taxes | 22,873,000 | (22,942,000 | ) | 45,815,000 | 70,809,000 | (5,341,000 | ) | 76,150,000 | |||||||||||||||||||||||
Provision for incometax expense (benefit) | 6,622,000 | (8,144,000 | )(c) | 14,766,000 | 22,458,000 | (1,896,000 | )(c) | 24,354,000 | |||||||||||||||||||||||
Net income (loss) | $ | 16,251,000 | $ | (14,798,000 | ) | $ | 31,049,000 | $ | 48,351,000 | $ | (3,445,000 | ) | $ | 51,796,000 | |||||||||||||||||
Basic earnings per share | $ | 1.22 | $ | 2.33 | $ | 3.75 | $ | 4.02 | |||||||||||||||||||||||
Diluted earnings per share | $ | 1.19 | $ | 2.28 | $ | 3.59 | $ | 3.85 | |||||||||||||||||||||||
Weighted average commonshares outstanding, basic | 13,302,000 | 13,302,000 | 12,878,000 | 12,878,000 | |||||||||||||||||||||||||||
Effect of potential common shares | 345,000 | 345,000 | 573,000 | 573,000 | |||||||||||||||||||||||||||
Weighted average commonshares outstanding, diluted | 13,647,000 | 13,647,000 | 13,451,000 | 13,451,000 |
(a) Amortization expense
(b) Net charge related to settlements and loss contingencies
(c) Total tax effect for non-GAAP pre-tax adjustments measured at enacted statutory rates
(UBIC) Achieves World First in Machine-Learning Document Analysis for Japanese and Korean
Accuracy and Speed of UBIC’s In-House-Developed Predictive Coding Technology Confirmed by Independent Review in Multiple Cases
TOKYO, July 9, 2013 (GLOBE NEWSWIRE) — UBIC, Inc. (TSE:2158) (Nasdaq:UBIC), a global provider of comprehensive eDiscovery and digital forensics solutions and services for corporations and law firms, announced today that the performance of its predictive coding technology has been validated by client review in cases involving Asian-language and English documents, a world first for UBIC’s technology.
UBIC’s predictive coding technology is based on machine-learning software that accurately and quickly reviews and codes large volumes of data in multiple languages including Japanese, Korean and English. To date, this technology has been successfully applied in electronic discovery (eDiscovery) projects to effectively code documents for use in cross-border litigation where its performance and accuracy was confirmed in independent review by client attorneys.
Cost of human review a burden
Discovery (and eDiscovery) is an essential fact-finding process in the contest of lawsuits and in administrative investigations related to state and federal laws in the United States (e.g., anti-monopoly or anti-corruption) and other, similar laws and regulations enforced by nations around the world. “The significance of UBIC’s predictive coding technology is its potential to reliably achieve the same or better accuracy as with human review while significantly reducing costs related to eDiscovery,” UBIC Chairman and Chief Executive Officer Masahiro Morimoto said.
Of the several stages involved in the eDiscovery process – which include the identification, collection, processing and storage of data – it is the review stage where individual attorneys sift through potentially relevant documents one-by-one to definitively establish relevance, that is often most cost intensive. Review costs are driven even higher when attorneys hired for review must possess specific “expert” knowledge such as multi-lingual capability or specific knowledge in engineering, medicine or other specialization.
“Fees associated with hiring attorneys to read and precisely code large volumes of documents have become huge burdens for corporations involved in litigation,” according to Mr. Morimoto.
Cost relief from UBIC technology
Significantly reducing the cost of human review is the need addressed by UBIC’s predictive coding technology, where machine-learning technology assists human (attorney) review with a performance in speed and accuracy that equals or betters human review, a performance standard UBIC has confirmed in numerous, large-scale international-litigation cases. At the same time, the cost savings and accuracy of predictive coding is acknowledged and supported in decisions by U.S. Courts and the U.S. Department of Justice – these same decisions further acknowledge the use of predictive coding as effective and acceptable in the discovery process.
Predictive coding technologies are available from several suppliers currently. “However, UBIC is the first company in the world to successfully develop a unique predictive coding technology that works with Japanese and Korean language documents and data,” Mr. Morimoto said. Moreover, Mr. Morimoto added, UBIC has used the technology in Japanese and Korean eDiscovery projects to successfully achieve significant increases in review accuracy and speed at substantially reduced costs.
UBIC is completing development of its predictive coding technology for Chinese-language data, according to Mr. Morimoto, who adds that this key project is underway at the company’s recently-opened R&D Center, which specializes in the development of improved data mining technologies and application of behavioral and information sciences-based artificial intelligence to current predictive coding technology.
“The R&D Center is also involved in exploring technologies and applications for UBIC’s predictive coding technology that go beyond electronic discovery,” Mr. Morimoto said.
About UBIC, Inc.
UBIC, Inc. is a leading provider of Asian-language eDiscovery solutions and services. UBIC has extensive eDiscovery and forensic experience and expertise with information documented in Japanese, Korean, Chinese as well as English languages, and applies its expertise in connection with cross-border litigation, administrative proceedings and internal investigations, including those related to anti-trust investigations, intellectual property (IP) litigation, the Foreign Corrupt Practices Act (FCPA) and product liability (PL) investigations. UBIC serves its clients, including leading law firms, corporate legal departments and government agencies, from offices in Japan, the United States, South Korea, Taiwan, Hong Kong and the United Kingdom.
For more information about UBIC, visit http://www.ubicna.com.
CONTACT: For more information, please contact: Sunil Mudunuri Sunil_mudunuri@ubicna.com (650) 654-7664
Intevac (IVAC) Names Wendell Blonigan President and CEO
Norm Pond Continues as Chairman
Intevac, Inc. (Nasdaq:IVAC) announced today that Mr. Wendell Blonigan will join the company as President and Chief Executive Officer (CEO) on July 15, 2013. Mr. Norman Pond, Intevac’s founder and current CEO, will continue as Chairman of the Board of Directors.
Mr. Blonigan, 51, brings to Intevac nearly 30 years of senior management and technical experience in the high-technology industry. He joins the company from Orbotech LT Solar, which he founded and where he had served as chief executive officer since 2009. Previously, he was chief operating officer of Photon Dynamics, which he joined in 2006 after serving as president of Applied Materials’ AKT display subsidiary. Mr. Blonigan’s extensive high-technology experience spans the semiconductor, flat panel display, and solar capital equipment markets.
“We are delighted that Wendell will become CEO of Intevac,” commented Mr. Pond. “He has a demonstrated track record of success managing high-technology equipment businesses as well as successfully bringing innovative products to market.”
“Intevac is uniquely positioned as an innovative company possessing strong technologies in both their equipment and photonics businesses,” said Mr. Blonigan. “I’m excited to join the Intevac team, where we will work together to deliver increasing value to our customers and shareholders.”
About Intevac
Intevac was founded in 1991 and has two businesses: Equipment and Intevac Photonics.
In our Equipment business, we are a leader in the design, development and manufacturing of high-productivity, vacuum process equipment solutions. Our systems are production-proven for high-volume manufacturing of small substrates with precise thin film properties, such as those required in the hard drive and solar cell markets we currently serve.
In the hard drive industry, our 200 Lean® systems process approximately 60% of all magnetic disk media produced worldwide. In the solar cell manufacturing industry, our LEAN SOLAR™ systems increase the conversion efficiency of silicon solar cells.
In our Photonics business, we are a leader in the development and manufacturing of leading-edge, high-sensitivity imaging products and vision systems. Our products primarily address the defense markets.
For more information call 408-986-9888, or visit the company’s website at www.intevac.com.
(CDTI) Advanced Platinum Group Metal Catalyst Featured on Accord Hybrids
VENTURA, Calif., July 9, 2013 (GLOBE NEWSWIRE) — Clean Diesel Technologies, Inc. (Nasdaq:CDTI) (“CDTi” or the “Company”), a leader in advanced emissions control solutions, is pleased to announce that Honda Motor Co. (“Honda”) is now selling its 2013 Accord Hybrid and Accord Plug-In Hybrid, featuring CDTi’s high-performance Mixed Phase Catalyst (MPC®) technology. The Hybrid is expected to begin production in the U.S. this summer with sales commencing in the U.S. in the fall while the Plug-In Hybrid model has recently become available for sale in the U.S.
Along with the Hybrid and Plug-In Hybrid models, CDTi also provides its catalyst solutions to Honda for North American versions of their four- and six-cylinder Accord as well as the Acura TSX.
The MPC design is focused on excellent thermal stability, giving its catalyst products three critical attributes that differentiate them from competing offerings:
- Allows significantly improved performance with a given level of precious metals – to meet increasingly stringent emissions standards and powertrain diversification
- Achieves a given emission standard with greatly reduced precious metal use
- Enables the development of ZPGM catalysts with unique activity and performance
“Hybrid and plug-in vehicles can improve fuel economy, lower fuel costs, and provide significant emissions benefits over conventional vehicles by producing no tailpipe emissions when in all-electric mode. Honda has been a leader in the advancement of hybrid vehicles and we are proud to be the supplier to such a premium brand. With advancing degrees of hybridization a much higher performance level from the catalyst is required due to the intermittent use of the combustion engine. The use of the CDTi catalyst by Honda for these types of vehicles is a strong endorsement of our capabilities. As global emission regulations continue to tighten, we are well positioned with our advanced MPC technology platform to deliver automakers increasingly cost-effective, high-performance catalyst emission solutions,” said Craig Breese, President and Chief Executive Officer of CDTi.
CDTi’s Catalyst Division began delivering catalysts to Honda in 2001 — offering a unique combination of high performance and low platinum group metal content, resulting in significant economic benefits. Since then, CDTi’s catalysts have been sourced for new model programs that typically span four to five years, including the popular model years 2004 and 2008 Accord.
About CDTi
CDTi is a vertically integrated global manufacturer and distributor of emissions control systems and products, focused on the heavy duty diesel and light duty vehicle markets. CDTi utilizes its proprietary patented Mixed Phase Catalyst (MPC®) technology, as well as its ARIS® selective catalytic reduction, Platinum Plus® fuel-borne catalyst, and other technologies to provide high-value sustainable solutions to reduce emissions, increase energy efficiency and lower the carbon intensity of on- and off-road engine applications. CDTi is headquartered in Ventura, California and currently has operations in the U.S., Canada, France, Japan and Sweden. For more information, please visit www.cdti.com.
Forward-Looking Statements Safe Harbor
Certain statements in this news release, such as statements regarding expected production and sales schedules, use of the Company’s products by Honda, anticipated benefits and competitive features of the Company’s products, future sales volumes and momentum, the Company’s relationship with Honda, tightening of emissions standards and regulations, and any impact the foregoing may have on the Company’s business, operations, growth, profitability and shareholder value, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known or unknown risks, including those detailed in Clean Diesel’s filings with the U.S. Securities and Exchange Commission, uncertainties and other factors that may cause the actual results, performance or achievements of Clean Diesel to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Clean Diesel assumes no obligation to update the forward-looking information contained in this release.
CONTACT: Kevin M. McGrath Cameron Associates, Inc. Tel: +1 (212) 245-4577
(AMBT) Awarded Application and Communications Contract by Consolidated Edison
Smart Grid Nodes to communicate with the Commercial and Industrial meters to retrieve power quality and billing data
NEWTON, Mass., July 9, 2013 /PRNewswire/ — Ambient Corporation (NASDAQ:AMBT), provider of a secure, flexible, and scalable communications and applications platform, today announced that Consolidated Edison Company of New York, Inc. (NYSE:ED) has contracted Ambient® to provide application development and communications equipment to replace discontinued technology for commercial and industrial metering. Following a year of testing and a successful pilot, this contract award signals the acceptance of the Ambient solution for a roll-out to further locations across the New York City area.
(Logo: http://photos.prnewswire.com/prnh/20090311/AMBIENTLOGO)
“Consolidated Edison needed a solution to interface with Commercial and Industrial (C&I) meters at remote customer premises to collect and transmit data directly to their control center. Ambient’s Smart Grid Nodes were selected due to their ability to meet all the specified criteria,” stated David Masters, Ambient’s Chief Technology Officer. “In addition, Ambient developed an application hosted locally on our node to collect, store, and transmit data from the meters.”
“It is a testament to the versatility of our communications and applications platform that Consolidated Edison selected Ambient for this commercial and industrial project,” said John J. Joyce, President and CEO of Ambient Corporation.
Ambient Corporation helps utilities modernize the grid with IP-based networking products and applications that integrate and connect existing and future grid assets on a secure, flexible, and scalable smart grid communications platform. Ambient’s Smart Grid Node family enables real-time data communication for multiple applications, in parallel: smart metering, distribution automation, power quality monitoring for voltage optimization, and more.
About Ambient Corporation
Ambient designs, develops and sells the Ambient Smart Grid®communications and applications platform. The Ambient Smart Grid products and services include communications nodes; a network management system, AmbientNMS®; integrated applications; and maintenance and consulting services. Using open standards-based technologies along with in-depth industry experience, Ambient provides utilities with solutions for smart grid initiatives. Headquartered in Newton, MA, Ambient is a publicly traded company (NASDAQ: AMBT). More information on Ambient is available at www.ambientcorp.com.
Except for historical information, this press release contains statements that may be deemed to be “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These include statements relating to the diversification of our customer base, further development and marketing of our communications platform and cultivating projects with potential customers, among others. These forward-looking statements are based upon our current expectations, estimates and projections about our business and our industry and reflect our beliefs and assumptions based upon information available to us at the date of this release. We caution readers that forward-looking statements are predictions based on our current expectations about future events. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Our actual results, performance or achievements could differ materially from those expressed or implied by the forward-looking statements as a result of a number of factors, which could have a material adverse effect on our operations and future prospects including, but not limited to, continuing compatibility of our platform with new utility applications and requirements, our ability to retain and attract customers, particularly in light of our dependence on a single customer for substantially all of our revenue; our expectations regarding our expenses and revenue, including our expectations that our research and development expenses and selling, general and administrative expenses may increase in absolute dollars; anticipated trends and challenges in our business and the markets in which we operate, including the market for smart grid technologies; our expectations regarding competition as more and larger companies enter our markets and as existing competitors improve or expand their product offerings; our plans for future products and enhancements of existing products; our anticipated cash needs and our estimates regarding our capital requirements; and our anticipated growth strategies. We undertake no obligation to publicly update or revise any forward-looking statements. Further information on the company’s risks and uncertainties is available in our filings with the Securities and Exchange Commission.
Ambient, AmbientNMS and Ambient Smart Grid are registered trademarks of Ambient Corporation.
CytRx’s (CYTR) Aldoxorubicin Shrinks Tumors and Prolongs Survival
CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced that aldoxorubicin, its more potent version of the widely used chemotherapeutic agent doxorubicin, demonstrated statistically significant efficacy (p<.0001) in the treatment of rapidly growing human brain (glioblastoma) cancer in the brains of animals. Complete results from this favorable confirmatory trial, which was conducted in collaboration with Louisiana State University (LSU) School of Medicine, will be presented at the European Society for Medical Oncology being held September 29-October 1 2013 in Amsterdam.
“We are surprised and excited about the effectiveness demonstrated by aldoxorubicin in this particularly difficult-to-treat cancer,” said Om Prakash, Ph.D., the study’s principal investigator and Research Professor of Medicine, Stanley S. Scott Cancer Center, Louisiana State University Health Sciences Center, New Orleans. “It has been well documented that doxorubicin, although active against glioblastoma cancer cells in tissue culture, does not cross the blood-brain barrier, the body’s natural defense system protecting the brain, to effectively treat patients with brain tumors. In fact, in our study doxorubicin was no more effective than saline in suppressing glioblastoma tumor growth. We have shown that aldoxorubicin uptake is confined only to the tumor in the brain and does not enter normal brain tissue. Thus, we would expect toxicity in the central nervous system to be negligible. Our conclusion from this trial is that aldoxorubicin has the potential to safely shrink glioblastoma tumors which could dramatically prolong the average survival time in patients. We initially had observed a similar effect of aldoxorubicin on glioblastoma in a preliminary study, and are quite pleased to have confirmed the result in a larger, well-controlled study that included native doxorubicin.”
Dr. Prakash’s main focus of his research efforts in the last few years has been to understand the pathogenesis and treatment of glioblastoma multiforme, the most malignant and the most deadly type of brain tumor. He is the corresponding author on several poster presentations in national/international meetings. More recently, he is the first author on a publication, Gliomas and Seizures in the Medical Hypothesis Journal (Prakash et al. 2012; 79:622).
“This trial produced remarkable results in a deadly cancer that virtually always returns regardless of whether treated with surgery, radiation, chemotherapy or a combination of methods,” said CytRx President and CEO Steven A. Kriegsman. “Animals treated with aldoxorubicin survived on average more than twice as long as those treated with saline or doxorubicin.
“Aldoxorubicin could provide an exciting new approach in how we attack brain tumors. These outstanding results support our plan to initiate a Phase 2b clinical trial with aldoxorubicin in patients with relapsed glioblastoma. We remain on track with expanding our aldoxorubicin clinical development activities and expect our progress to accelerate in the coming months and year,” he added. If the data from the company’s planned Phase 2b clinical trial for glioblastoma are positive, it plans to file for breakthrough therapy designation with the U.S. Food and Drug Administration, which could expedite marketing approval for aldoxorubicin.
Aldoxorubicin has shown to be superior to doxorubicin in seven different tumor types and animal models of cancer, including ovarian, lung, breast and pancreatic cancer, as well as multiple myeloma, and has demonstrated activity in human trials for the treatment of soft tissue sarcomas and other cancers. Aldoxorubicin is the first drug candidate CytRx is developing based on a novel linker technology that has proven ability to allow attachment of multiple chemotherapeutic agents and is designed to provide both greater anti-cancer activity and to mitigate the toxicity that limits these agents’ use.
About Glioblastoma Multiforme
Glioblastom multiforme (GBM) is the most common and most malignant brain tumor in adults and afflicts more than 12,000 new patients in the U.S. annually. Despite surgical resection, radiotherapy and chemotherapy, the median survival after diagnosis is about 12-14 months. Although the reason for treatment failure may depend upon several factors, limited efficacy of chemotherapeutic agents has been attributed to several contributing factors including insufficient drug delivery to the tumor site through the blood-brain barrier.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. The CytRx oncology pipeline is focused on the clinical development of aldoxorubicin (formerly known as INNO-206), its improved version of the widely used chemotherapeutic agent doxorubicin. CytRx has initiated an international Phase 2b clinical trial with aldoxorubicin as a treatment for soft tissue sarcomas, has completed its Phase 1b/2 clinical trial primarily in the same indication and a Phase 1b study of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors, and is conducting a Phase 1b pharmacokinetics clinical trial in patients with metastatic solid tumors. The Company is initiating a Phase 3 pivotal trial under a special protocol assessment (SPA) with aldoxorubicin as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy. CytRx is expanding its pipeline of oncology candidates based on a novel linker platform technology that can be utilized with multiple chemotherapeutic agents and could allow for greater concentration of drug at tumor sites. The Company also has rights to two additional drug candidates, tamibarotene and bafetinib. The Company completed its evaluation of bafetinib in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL), and plans to seek a partner for further development of bafetinib, and is evaluating further development of tamibarotene. For more information about CytRx Corporation, visit www.cytrx.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks relating to the outcome, timing and results of CytRx’s clinical trials, the risk that any future human testing of aldoxorubicin might not produce results similar to those seen in past human or animal testing, including the mouse study described in this press release, risks related to CytRx’s ability to manufacture its drug candidates in a timely fashion, cost-effectively or in commercial quantities in compliance with stringent regulatory requirements, risks related to CytRx’s need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, including the Phase 3 clinical development of aldoxorubicin, and the risks and uncertainties described in the most recent annual and quarterly reports filed by CytRx with the Securities and Exchange Commission and current reports filed since the date of CytRx’s most recent annual report. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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