Archive for November, 2015
(FGEN) to Present Roxadustat Clinical Data
SAN FRANCISCO, Nov. 03, 2015 — FibroGen, Inc. (NASDAQ:FGEN) (“FibroGen”), today announced that analyses of clinical data from Phase 2 clinical trials of roxadustat (FG‑4592), a potential first-in-class oral compound in late-stage development for the treatment of anemia associated with chronic kidney disease (CKD), will be presented at the American Society of Nephrology (ASN) Kidney Week on November 5, 2015.
Roxadustat is currently in Phase 3 development as a potential therapy for anemia of chronic kidney disease both in patients on dialysis and in patients not on dialysis. The global development program is being conducted by FibroGen and its development partners, AstraZeneca and Astellas.
The schedule and details for the presentations are as follows:
- Anemia Correction with Roxadustat Lowers Hepcidin in Chronic Kidney Disease (both CKD and ESRD) Patients in Phase 2 Studies
Session: CKD: Clinical Trials
Thursday, November 5, 2015 10:00 AM – 12:00 PM PT
Abstract Session # TH-PO646 (Szczech, et al.)
- Anemia Correction with Roxadustat Increases Soluble Transferrin Receptor in Chronic Kidney Disease (CKD) Patients in Phase 2 Studies
Session: CKD: Clinical Trials
Thursday, November 5, 2015 10:00 AM – 12:00 PM PT
Abstract Session # TH-PO647 (Szczech, et al.)
- Anemia Correction with Roxadustat Lowers Cholesterol in Chronic Kidney Disease (CKD) Patients in Phase 2 Studies
Session: CKD: Clinical Trials
Thursday, November 5, 2015 10:00 AM – 12:00 PM PT
Abstract Session # TH-PO648 (Szczech, et al.)
- Anemia Correction with Roxadustat Improves Health Related Quality of Life (HRQOL) in Chronic Kidney Disease (CKD) Patients in Phase 2 Studies
Session: Clinical Trials in CKD: Pursuing a New Horizon
Thursday, November 5, 2015, 6:06 PM PT
Oral Program # TH-OR039 (Szczech, et al.)
About Chronic Kidney Disease
CKD affects more than 200 million people worldwide and more than 30 million adults in the U.S. Although it can occur at any age, it becomes more common in aging populations and its prevalence is increasing. Kidney disease can have multiple causes such as diabetes mellitus and hypertension. While there are treatments for many causes of kidney disease, there are currently no treatments that are curative or that can completely halt the loss of kidney function in CKD, creating a significant unmet medical need.
About Roxadustat
Roxadustat (FG-4592) is an orally administered small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase activity, in development for the treatment of anemia of chronic kidney disease both in patients on dialysis and in patients not on dialysis. Hypoxia-inducible factor is a transcription factor that induces the natural physiological response to conditions of low oxygen, “turning on” erythropoiesis (the process by which red blood cells are produced) and other protective pathways.
About FibroGen
FibroGen is a research-based biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics to treat serious unmet medical needs. We have capitalized on our extensive experience in fibrosis and hypoxia-inducible factor (HIF) biology to generate multiple programs targeting various therapeutic areas. Our most advanced product candidate, roxadustat, or FG-4592, is an oral small molecule inhibitor of HIF prolyl hydroxylases (HIF-PHs), in Phase 3 clinical development for the treatment of anemia in chronic kidney disease (CKD). Our second product candidate, FG-3019, is a monoclonal antibody in Phase 2 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), pancreatic cancer and liver fibrosis. For more information about FibroGen, please visit www.fibrogen.com.
Contact Greg Mann FibroGen, Inc. (415) 978-1433 gmann@fibrogen.com
(TANH) Establishes Wholly-Owned PRC Subsidiary for its BBQ Products
LISHUI, China, Nov. 3, 2015 — Tantech Holdings Ltd. (NASDAQ: TANH) (“Tantech” or the “Company”), a leading manufacturer of bamboo-based charcoal products, announced today that it has established a wholly-owned subsidiary, Zhejiang Babiku Charcoal Co., Ltd. (“Babiku”), a PRC company with registered capital of RMB10 million, to manage its BBQ products business.
The Company is in the process of transferring its self-produced BBQ products business, currently managed by Zhejiang Tantech Energy Technology Co., Ltd. (“Energy Tech”), a wholly owned subsidiary, to Babiku. The Company currently sells two categories of BBQ products, 1) OEM BBQ Charcoal – non-bamboo based charcoal briquettes produced by third parties, and 2) self-produced BBQ Charcoal – bamboo based charcoal briquettes produced in the Company’s Lishui facility and primarily sold in the international market.
As a result of today’s announcement, the Company will have three wholly-owned manufacturing subsidiaries managing the three key product categories separately and independently, with Babiku for self-produced BBQ products, Energy Tech for EDLC carbon products, and Zhejiang Tantech Bamboo Charcoal Co., Ltd. (“Tantech Charcoal”) for branded Charcoal Doctor products. The new corporate structure, with improved focus and accountability, is expected to allow the Company to manage its businesses more effectively.
About Tantech Holdings Ltd.
Established in 2001 and headquartered in Lishui City, Zhejiang Province, China, Tantech Holdings Ltd., together with its subsidiaries, develops and manufactures bamboo-based charcoal products in China and internationally. It operates through three segments: Consumer Products, Trading, and Biofuel Energy. The company produces pressed and formed charcoal briquettes for use in grills, incense burners, and other applications under the Algold brand. It also offers Charcoal Doctor branded products, such as air purifiers and humidifiers, automotive accessories for air purification, underfloor humidity control, pillows and mattresses, wardrobe deodorizers, mouse pads and wrist mats, refrigerator deodorants, charcoal toilet cleaner disks, liquid charcoal cleaners, shoe insoles, and decorative charcoal gifts. In addition, the Company provides liquid byproduct consists of bamboo vinegar that is used in disinfectants, detergents, lotions, specialized soaps, toilet cleaners, and fertilizers, as well as in various agricultural applications. Further, it engages in providing bamboo carbon for use in EDLCs; the production of electric double-layer capacitor carbon products; and the industrial purchase and sale of rubber. The Company provides its products for industrial energy applications, as well as household cooking, heating, purification, agricultural, and cleaning uses. The company also exports its bamboo vinegar, bamboo charcoal purification, and EDLC carbon products. For more information about Tantech Holdings Ltd., please visit: http://www.tantech.cn/en/index.asp
Forward-Looking Statements
This news release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements that are other than statements of historical facts. These statements are subject to uncertainties and risks including, but not limited to, product and service demand and acceptance, changes in technology, economic conditions, the impact of competition and pricing, government regulations, and other risks contained in reports filed by the company with the Securities and Exchange Commission. All such forward-looking statements, whether written or oral, and whether made by or on behalf of the Company, are expressly qualified by this cautionary statement and any other cautionary statements which may accompany the forward-looking statements. In addition, the Company disclaims any obligation to update any forward-looking statements to reflect events or circumstances after the date hereof.
For more information please contact:
Tantech Holdings Ltd.
Ms. Ye Ren
IR Manager
+86-578-261-2869
ir@tantech.cn
Weitian Investor Relations
Ms. Tina Xiao
+1-917-609-0333
TANH@weitian-ir.com
(IMDZ) Preclinical Data on G100 and ZVex(TM)
Demonstrates Potential of “Prime-Pull” Immunotherapy Approach
SEATTLE and SOUTH SAN FRANCISCO, Calif., Nov. 3, 2015 — Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, today announced new preclinical data showing that a dendritic-cell targeting lentiviral vector from its ZVex™ immunotherapy platform administered with G100, which contains a potent synthetic TLR4 agonist, synergize with immune check point inhibitors and demonstrate potent local and systemic anti-tumor activity in cancer models. These data are being presented at the 30th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) Conference, National Harbor, Maryland, November 4-8, 2015.
“These findings further illustrate the potential of ZVex-based product candidates and G100 to play an important role in the emerging field of cancer immunotherapy, especially in potential combination therapies with immune checkpoint inhibitors,” said Jan ter Meulen, MD, PhD, Chief Scientific Officer at Immune Design. “Mechanistically, it is generally believed that the generation of tumor-specific CD8 T-cells can improve the clinical efficacy of checkpoint inhibitors, especially in patients with insufficient T-cell responses. These preclinical data provide a strong rationale for our ongoing and planned clinical trials which combine LV305, CMB305 and G100, agents from our ZVex and GLAAS discovery platforms, with KEYTRUDA and Atezolizumab.”
In the presentations, Immune Design scientists present data showing that in the murine B16 melanoma model, intratumoral injection of G100 improves the trafficking of ZVex-induced antigen-specific CD8 T-cells into tumors and induces systemic anti-tumor immunity mediated by antigen spreading. This discovery that Immune Design’s two platforms appear to “pull” T cells (G100) that were “primed” (ZVex agent) into the tumor potentially opens up new possibilities of enhancing the immunotherapy of solid tumors by changing the tumor microenvironment. In addition, combining G100 or a ZVex agent with both anti-PD1 and anti-PDL1 antibodies demonstrated increased efficacy in this experiment. The presentations are entitled “Intratumoral Injections of G100 (synthetic TLR4 agonist) Increases Trafficking of Lentiviral Vector-induced Antigen-specific CD8 T Cells to the Tumor Microenvironment” and “Checkpoint Inhibitors Synergize with Therapeutic Platforms, ZVex™ and GLAAS™ by Enhancing Lentiviral Vector-induced Tumor-specific Immunity and Adjuvant-mediated Anti-tumor Efficacy.”
These abstracts will be published in the Journal for ImmunoTherapy for Cancer on November 4, 2015, and the posters will be posted on the publications page of the Immune Design website following presentation at the conference.
About G100
G100 is a product candidate generated from the company’s GLAASTM discovery platform, and includes a specific formulation of Glucopyranosyl Lipid A (GLA), a synthetic, toll-like receptor-4 (TLR-4) agonist. G100 is part of Immune Design’s intratumoral immune activation, or ‘Endogenous Antigen’ approach to treating cancer, which leverages the activation of dendritic cells, T cells and other immune cells in the tumor microenvironment to potentially create a robust immune response against the tumor’s preexisting diverse set of antigens. Preclinical and clinical data have demonstrated the ability of G100 to activate dendritic cells in tumors and to increase antigen-dependent systemic humoral and cellular Th1 immune responses. A Phase 1 study of G100 in patients with Merkel cell carcinoma (MCC) recently completed enrollment, and Immune Design presented data at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting. In the first eight patients in MCC study, G100 had an acceptable safety profile and the combined therapy of G100 followed by radiation and/or surgery resulted in an objective response rate (ORR) of 50%. A second Phase 1 trial is planned to examine intratumoral administration of G100 with intravenous administration of KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with follicular non-Hodgkin’s lymphoma receiving local radiation. In addition to an evaluation of the safety of the combination, the study will assess the response in both injected and non-injected lesions.
About ZVex™
ZVex is Immune Design’s discovery platform designed to activate and expand the immune system’s natural ability to create tumor-specific cytotoxic T cells (CTLs) in vivo.
The ZVex delivery system uses a re-engineered virus to carry genetic information of a tumor antigen selectively to dendritic cells (DCs) in the skin. This ultimately results in the creation of CTLs designed to kill tumor cells bearing that same specific tumor antigen.
About Immune Design
Immune Design is a clinical-stage immunotherapy company employing next-generation in vivo approaches to enable the body’s immune system to fight disease. The company’s technologies are engineered to activate the immune system’s natural ability to generate and/or expand antigen-specific cytotoxic T cells, while also enhancing other immune effectors, to fight cancer and other chronic diseases. CMB305 and G100, the primary focus of Immune Design’s ongoing immuno-oncology clinical programs, are products of its two synergistic discovery platforms, ZVexTM and GLAASTM, the fundamental technologies of which were licensed from the California Institute of Technology and the Infectious Disease Research Institute (IDRI), respectively. Immune Design has offices in Seattle and South San Francisco. For more information, visit www.immunedesign.com.
Forward Looking Statement:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Immune Design’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the timing of initiation, progress, scope and outcome of clinical trials for Immune Design’s product candidates and the reporting of clinical data regarding Immune Design’s product candidates. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of Immune Design’s collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. Other factors that may cause Immune Design’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Immune Design’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein. Except as required by law, Immune Design assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
CONTACT: Contact for Immune Design: Media Contact Julie Rathbun Rathbun Communications julie@rathbuncomm.com 206.769.9219 Investor Contact Shari Annes Annes Associates sannes@annesassociates.com 650-888-0902
(CTMX) Appoints Matthew Young to Board of Directors
SOUTH SAN FRANCISCO, Calif., Nov. 3, 2015 — CytomX Therapeutics (Nasdaq: CTMX), a biopharmaceutical company developing investigational Probody™ therapeutics for the treatment of cancer, today announced that Matthew Young has joined the company’s board of directors. Mr. Young currently serves as chief financial officer of Jazz Pharmaceuticals, and brings more than two decades of experience in finance.
“Matt’s broad financial expertise and long-standing relationships with the investment community enrich our growing board of directors,” said Sean McCarthy, D. Phil, chief executive officer of CytomX. “His extensive corporate development experience and financial acumen will help guide us as we advance our innovative Probody pipeline and build CytomX for the long term.”
Mr. Young was appointed executive vice president and chief financial officer of Jazz Pharmaceuticals in February 2015. He previously held numerous positions within Jazz, including senior vice president, corporate development. Prior to joining the company, Mr. Young worked in investment banking for approximately 20 years. From 2009 to 2013, he served as a managing director in global healthcare of Barclays Capital, including acting as the co-head of life sciences. From 2007 to 2008, Mr. Young served as a managing director of Citigroup Global Markets, and from 2003 to 2007 as a managing director of Lehman Brothers. From 1992 to 2003, Mr. Young served in various capacities at other investment banking firms. In 2015, he joined the board of directors of PRA Health Sciences, a contract research company. Mr. Young received a bachelor’s degree in economics and a master’s in business from the Wharton School of the University of Pennsylvania.
About CytomX Therapeutics
CytomX is an oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody technology platform. The company uses the platform to create development-stage proprietary cancer immunotherapies against clinically-validated targets, as well as to develop first-in-class investigational cancer therapeutics against novel targets. CytomX believes that its Probody platform has the potential to improve the combined efficacy and safety profile of monoclonal antibody modalities, including cancer immunotherapies, antibody drug conjugates and T-cell-recruiting bispecific antibodies. Probody therapeutics are designed to take advantage of unique conditions in the tumor microenvironment to enhance the tumor-targeting features of an antibody and reduce drug activity in healthy tissues. Investigational Probody therapeutics are being developed that address clinically-validated cancer targets in immuno-oncology, such as PD-L1 against which our clinical candidate CX-072 is directed, as well as novel targets, such as CD-166, that are difficult to drug without causing damage to healthy tissues, or toxicities. In addition to its proprietary programs, CytomX is collaborating with strategic partners including Bristol-Myers Squibb Company, Pfizer Inc. and ImmunoGen, Inc. For more information, visit www.cytomx.com.
Forward-Looking Statements
This press release includes forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that are difficult to predict, may be beyond our control, and may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in such statements. Accordingly, you should not rely on any of these forward-looking statements. Our Probody platform is in preclinical development, and the process by which a preclinical technology could potentially lead to an approved product is long and subject to significant risks and uncertainties. Applicable risks and uncertainties include those relating to our preclinical research and development and other risks identified under the heading “Risk Factors” included in our filings with the SEC. The forward-looking statements contained in this press release are based on information currently available to CytomX and speak only as of the date on which they are made. CytomX does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise.
Media Contacts:
Canale Communications
Ian Stone
ian@canalecomm.com
619-849-5388
Investor Contacts:
Trout Group
Pete Rahmer
prahmer@troutgroup.com
646-378-2973
(KERX) Announces Participation at Two Upcoming Investor Conferences
BOSTON, Nov. 03, 2015 — Keryx Biopharmaceuticals, Inc, (NASDAQ:KERX), a biopharmaceutical company focused on bringing innovative therapies to market for people with renal disease, today announced that corporate presentations would be delivered at the following upcoming investor conferences.
Credit Suisse 24th Annual Healthcare Conference
Presenter: Greg Madison, Chief Executive Officer
Presentation Date: Tuesday, November 10, 2015
Presentation Time: 10:00 a.m. MST (12:00 p.m. EST)
Stifel 2015 Healthcare Conference
Presenter: Greg Madison, Chief Executive Officer
Presentation Date: Tuesday, November 17, 2015
Presentation Time: 11:00 a.m. EST
Live audio webcasts of these presentations will be accessible from Keryx’s website at http://investors.keryx.com within the Investor Relations section under the “webcasts and presentations” page. Archived versions of these webcasts will be available for at least 15 days following the conclusion of the live presentation.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals, with offices in New York and Boston, is focused on bringing innovative therapies to market for patients with renal disease. In December 2014, the company launched its first FDA-approved product, Auryxia™ (ferric citrate) for the control of elevated serum phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease (CKD) on dialysis, in the United States. In January 2014, ferric citrate was approved for the treatment of patients with all stages of CKD in Japan, where it is being marketed as Riona® by Keryx’s Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd. In September 2015, the European Commission granted European market authorization for Fexeric® (ferric citrate coordination complex) for the control of hyperphosphatemia in adults with non-dialysis and dialysis-dependent chronic kidney disease. For more information about Keryx, please visit www.keryx.com.
KERYX CONTACT: Lora Pike Senior Director, Investor Relations T: 617-466-3511 lora.pike@keryx.com
(ISCO) Moves Forward With Parkinson’s Disease Clinical Trials in Australia
CARLSBAD, CA–(November 03, 2015) – International Stem Cell Corporation (OTCQB: ISCO), a California-based biotechnology company developing novel stem cell-based therapies and biomedical products, announced today that after a recent meeting with Australian Therapeutics Goods Administration (TGA) the Company’s wholly owned subsidiary Cyto Therapeutics signed a Letter of Intent (LOI) with Royal Melbourne Hospital (Australia) to conduct phase I/IIa clinical trials of ISCO’s proprietary human parthenogenetic neural stem cells (hPNSCs) for the treatment of Parkinson’s Disease. Under this process, a full agreement will be signed after TGA and the HREC approve the clinical protocol for the phase I/IIa trials.
“We had a productive meeting with TGA where we discussed the clinical protocol and potentially came to an agreement on all remaining items. We look forward to receiving TGA approval for clinical trials in November and enrolling patients soon thereafter,” said Russell A. Kern, Ph.D., chief scientific officer of ISCO.
ISCO’s Parkinson’s disease program uses human parthenogenetic neural stem cells (hPNSC) which are a novel therapeutic cellular product derived from the Company’s proprietary human pluripotent stem cells. hPNSC are self-renewing multipotent cells that are precursors for the major cells of the central nervous system. The ability of hPNSC to differentiate into dopaminergic neurons and express neurotrophic factors to protect the nigrostriatal system offers a potential new opportunity for the treatment of Parkinson’s disease.
About International Stem Cell Corporation
International Stem Cell Corporation (ISCO) is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO’s core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at www.internationalstemcell.com.
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Safe harbor statement
Statements pertaining to anticipated developments, expected clinical studies (including timing and results of both the studies and regulatory approvals), progress of research and development initiatives, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company’s business, particularly those mentioned in the cautionary statements found in the company’s Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.
Contact
International Stem Cell Corporation
Russell A. Kern, PhD
Phone: +1-760-940-6383
Email: ir@intlstemcell.com
Media:
Christopher R. Hippolyte
Phone: +1-646-942-5634
Email: chris.hippolyte@russopartnersllc.com
Amiad Finkelthal
Phone: +1-646-942-5626
amiad.finkelthal@russopartnersllc.com
(EXAS) Aims to Collaborate with City of Madison & University of Wisconsin
Madison-Based Manufacturer of Cologuard Focuses on a Scalable Environment that Expands Existing Footprint
Exact Sciences Corp. (NASDAQ: EXAS) announced today that it will continue collaborating with the City of Madison in an attempt to establish a headquarters in Madison and is in discussions with the University of Wisconsin to develop a biotech campus that expands the company’s existing operations and research and development facilities.
“This is an opportunity to work with the city, build on our current footprint in Madison and partner with the University to continue grooming its aspiring talent,” said Exact Sciences Chairman and CEO Kevin Conroy. “We’re grateful for the Mayor and the City Council’s efforts to help efficiently bring our teams together. While the chance to build a headquarters downtown was incredibly appealing, an opportunity to develop a campus allows us to bring our team together and make a prudent investment that benefits the company and community for the long term.”
Exact Sciences and its more than 425 Madison-based employees are currently stretched across three buildings in the University Research Park and the 35,000 square foot Exact Sciences Laboratories. More than sixty percent of Exact Sciences research and development staff are graduates of the UW-System.
“The City understands and respects the reasons that Exact Sciences will not be moving its corporate headquarters to the downtown. I am encouraged that the company plans to focus its future facility planning in the City of Madison at University Research Park. We will now proceed to review other development plans for parking, a new hotel and other commercial development on the downtown site,” said Madison Mayor Paul Soglin. “City staff as well as those from Exact Sciences and the Hammes Corporation have invested hundreds of hours of work into this project and I am grateful for the commitment.”
“I’m pleased that through University Research Park, UW-Madison is able to help the city and Exact Sciences find a solution that keeps the company in Madison. We look forward to continuing to partner with Exact Sciences on workforce development and lifesaving research,” said University of Wisconsin-Madison Chancellor Rebecca Blank.
“University Research Park is one of the most concentrated communities of life sciences companies in the Midwest,” said University Research Park Managing Director Aaron Olver. “We’re proud to be called home by Exact Sciences and look forward to the opportunity to support their continued growth.”
Established in 1984, University Research Park is an internationally recognized research and technology park that supports early-stage and growth-oriented businesses in a range of sectors, including engineering, computer and life sciences. The park is home to more than 125 companies employing more than 3,800 workers. University Research Park is a non-profit 501(c)(3) affiliated with the University of Wisconsin-Madison.
About Exact Sciences Corp.
Exact Sciences Corp. is a molecular diagnostics company focused on the early detection and prevention of the deadliest forms of cancer. The company has exclusive intellectual property protecting its noninvasive, molecular screening technology for the detection of colorectal cancer. Cologuard is included in the colorectal cancer screening guidelines of the American Cancer Society and stool DNA is included in the U.S. Multi-Society Task Force on Colorectal Cancer. For more information, please follow us on Twitter @ExactSciences or find us on Facebook.
About Cologuard
Cologuard was approved by the FDA in August 2014 and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the colorectal cancer screening guidelines of the American Cancer Society and stool DNA is listed in the screening guidelines of the U.S. Multi-Society Task Force on Colorectal Cancer.
Cologuard is indicated to screen adults of either sex, 50 years or older, who are at average risk for colorectal cancer. Cologuard is not for everyone and is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. False positives and false negatives do occur. Any positive test result should be followed by a diagnostic colonoscopy. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. Cologuard performance when used for repeat testing has not been evaluated or established. For more information about Cologuard, visit www.CologuardTest.com. Rx Only.
Exact Sciences:
J.P. Fielder, 608-210-5220
jfielder@exactsciences.com
(ZSAN) Positive Phase 1 Results, ZP-Triptan Patch for Migraine
ZP-Triptan Patch is Well-Tolerated and Achieves Rapid Absorption With Potential for Fast Relief Alternative for Migraine Patients
FREMONT, Calif., Nov. 02, 2015 — Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage specialty pharmaceutical company, today announced positive results from the Phase 1 clinical trial of its proprietary ZP-Triptan patch treatment for migraine.
ZP-Triptan is a zolmitriptan-coated microneedle patch that is applied to an individual’s upper arm to deliver zolmitriptan to the body. The objective of the Phase 1 clinical study was to evaluate the tolerability and pharmacokinetics of the ZP-Triptan patch in healthy volunteers. The crossover study among 20 healthy volunteers tested five doses of ZP-Triptan compared to an oral administration of zolmitriptan and additionally a subcutaneous injection of sumatriptan. ZP-Triptan demonstrated rapid absorption compared to the zolmitriptan tablet. All treatments were well tolerated and no safety issues were identified. The results for the sumatriptan injection were similar to those reported in the literature.
Cmax (SD) ng/ml |
Tmax (range) minutes |
AUC0-2hr (SD) ng/ml hour |
AUC0-last (SD) ng/ml hour |
|||||
ZP-Triptan 0.48 mg | 1.8 (0.53) | 20 (2-30) | 2.1 (0.73) | 2.8 (1.36) | ||||
ZP-Triptan 2 x 0.48 mg | 3.7 (1.05) | 20 (2-30) | 4.2 (0.95) | 6.5 (1.97) | ||||
ZP-Triptan 1.9 mg | 6.8 (2.75) | 20 (2-30) | 7.4 (2.53) | 12.3 (4.31) | ||||
ZP-Triptan 2 x 1.9 mg | 14.6 (4.46) | 17.5 (2-30) | 16.4 (5.34) | 27.8 (9.93) | ||||
ZP-Triptan 3.8 mg | 22.6 (14.00) | 15 (2-30) | 19.3 (5.37) | 31.7 (8.35) | ||||
Zolmitriptan Oral Tablet | 3.8 (1.51) | 60 (30-240) | 4.7 (2.24) | 22.2 (10.79) | ||||
Note: Mean values (median for Tmax) for the various zolmitriptan treatments are shown in the table above
“We are extremely pleased with the tolerability and pharmacokinetic results from our ZP-Triptan Phase 1 study,” said Thorsten von Stein, MD, PhD, Zosano Chief Medical Officer. “We expect that the demonstrated fast absorption will translate into fast pain relief. If so, ZP-Triptan’s fast absorption and simple injection-free administration may represent a strong product option for patients suffering from migraines. We look forward to discussing the program with the U.S. Food and Drug Administration (FDA) and to advancing clinical development.”
The company, which holds exclusive global rights to develop and commercialize the ZP-Triptan patch, intends to discuss further development plans with FDA and expects to initiate a Phase 2 clinical trial in 2016.
About Zosano Pharma
Zosano Pharma Corporation is a clinical-stage specialty pharmaceutical company that has developed a proprietary transdermal microneedle patch system to deliver drug formulations through the skin for the treatment of a variety of indications. Zosano Pharma’s microneedle patch system offers rapid onset, consistent drug delivery, improved ease of use and room-temperature stability, benefits that the company believes often are unavailable using oral formulations or injections. Zosano Pharma’s microneedle patch system has the potential to deliver numerous medications for a wide variety of indications in commercially attractive markets. It has been tested in more than 400 patients with over 30,000 patches successfully applied to humans in Phase 1 and Phase 2 clinical studies. Learn more at www.zosanopharma.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding the timing of clinical trial data and other expectations, beliefs and future events. Readers are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “might,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “forecast,” “designed,” “goal,” “unaudited,” “approximately” or the negative of those words or other comparable words to be uncertain and forward-looking. These statements are subject to risks and uncertainties that are difficult to predict and actual outcomes may differ materially. These include risks and uncertainties, without limitation, associated with the process of discovering, developing and commercializing products that are safe and effective for use as human therapeutics, risks inherent in the effort to build a business around such products and other risks and uncertainties described under the heading “Risk Factors” in Zosano Pharma Corporation’s Annual Report on Form 10-K for the year ended December 31, 2014 filed with Securities and Exchange Commission on March 26, 2015. Although the company believes that the expectations reflected in these forward-looking statements are reasonable, it cannot in any way guarantee that the future results, level of activity, performance or events and circumstances reflected in forward-looking statements will be achieved or occur. All forward-looking statements are based on information currently available to Zosano Pharma and Zosano Pharma assumes no obligation to update any such forward-looking statements.
Zosano Contact: Vikram Lamba Chief Executive Officer 510-745-1200 Investor Contact: Patti Bank Westwicke Partners 415-513-1284 patti.bank@westwicke.com Media Contact: Jamie Lacey-Moreira PressComm PR, LLC 410-299-3310 jamielacey@presscommpr.com
(BLCM) to Present at Two Healthcare Conferences in November
Bellicum Pharmaceuticals, Inc. (Nasdaq:BLCM), a clinical stage biopharmaceutical company focused on discovering and developing novel cellular immunotherapies, today announced that Tom Farrell, President and CEO, will present a corporate overview at two healthcare investor conferences in November.
24th Annual Credit Suisse Healthcare Conference
- Location: The Phoenician, Scottsdale, AZ
- Presentation Date: Tuesday, November 10, 2015
- Presentation Time: 11:00 a.m. MST (1 p.m. EST)
Jefferies 2015 Global Healthcare Conference
- Location: The May Fair Hotel, London, UK
- Presentation Date: Thursday, November 19, 2015
- Presentation Time: 2:00 p.m. GMT (9:00 a.m. EST)
The presentations will be webcast live and may be accessed from the News & Events section of the Bellicum website. Archived versions of the webcasts will be available for replay for at least two weeks following the events.
About Bellicum Pharmaceuticals
Bellicum is a clinical stage biopharmaceutical company focused on discovering and developing novel cellular immunotherapies for various forms of cancer, including hematological cancers and solid tumors, as well as orphan inherited blood disorders. The Company is using its proprietary Chemical Induction of Dimerization, or CID, technology platform to engineer and control components of the immune system in real time. Bellicum is developing next-generation product candidates in some of the most important areas of cellular immunotherapy, including hematopoietic stem cell transplantation (HSCT), and CAR T and TCR cell therapies. More information can be found at www.bellicum.com.
Investors:
Bellicum Pharmaceuticals
Alan Musso, CFO
832-384-1116
amusso@bellicum.com
or
Media:
BMC Communications
Brad Miles, 646-513-3125
bmiles@bmccommunications.com
(CONN) Closing of Amended/Restated Credit Facility, Authorization of New Repurchase Program
Conn’s, Inc. (NASDAQ:CONN) (the “Company”), a specialty retailer of furniture and mattresses, home appliances, consumer electronics and home office products, and provider of consumer credit announced today that it has amended and restated its asset-based revolving credit facility (the “Amended Credit Facility”) that, among other things:
- Provides total commitments of $810 million;
- Extends the maturity date from November 25, 2017 to October 30, 2018;
- Increases the total leverage ratio covenant from 2.0x to 4.0x;
- Eliminates the fixed charge coverage ratio covenant and replaces it with an interest coverage covenant; and
- Adds a new minimum liquidity requirement for repurchases of the Company’s common stock, notes and other debt pre-payment, which, combined with the new total leverage ratio covenant, is expected to provide the Company greater flexibility for repurchases.
Concurrently with execution of the Amended Credit Facility, the Company executed a Second Supplemental Indenture (the “Supplemental Indenture”) to the Indenture (as supplemented or amended, the “Indenture”) that governs the Company’s 7.250% Senior Notes due 2022 (the “Notes”). The Supplemental Indenture changes the restricted payments provisions under the Indenture by:
- Amending, from May 1, 2014 to November 1, 2015, the beginning of the accounting period from which consolidated net income is calculated for purposes of determining the size of the “restricted payment basket” exception to the restricted payments limitation; and
- Increasing, from $75.0 million to $375.0 million, the dollar threshold exception to the restricted payments limitation (together with the first point, the “Indenture Amendments”).
The Indenture Amendments were approved by the holders of a majority in principal amount of the Notes through the Company’s consent solicitation that was completed on October 29, 2015.
Norm Miller, Conn’s President and Chief Executive Officer commented, “We are pleased with the successful completion of these amendments and believe they reflect the confidence of our lenders and bond holders in our company. The credit facility, combined with expected future securitizations and use of high-yield notes provides us with ample liquidity to pursue our growth initiatives supported by a diversified capital structure.”
“With the completion of the amendments to our bank facility and senior notes indenture, we are also pleased to announce an additional $100 million share repurchase program which supports our goal of returning value to our shareholders while investing in our business and improving our capital structure. We intend to complete the repurchases under this authorization during our fiscal quarter ending January 31, 2016, as long as market conditions and other factors continue to support such use of our capital. The amendments to our bank facility and senior note indenture give us the ability to consider additional repurchase programs over time, dependent on market conditions, capital availability and other factors.”
The Company utilized substantially all of its authorization available under the previously approved $75 million repurchase program. During the quarter ended October 31, 2015, the Company purchased 1.9 million shares, using $51.6 million of its $75 million stock and bond repurchase authorization. Additionally, the Company utilized $22.9 million of the repurchase authorization to acquire $23.0 million of face of value of its senior notes. As a result of the bond repurchases, the Company incurred a loss during the quarter of approximately $0.5 million, related primarily to the write-off of deferred costs related to the bonds acquired. Additionally, the Company will write off approximately $0.9 million of deferred costs related to the amendment of its bank facility.
About Conn’s, Inc.
The Company is a specialty retailer currently operating approximately 100 retail locations in Arizona, Colorado, Georgia, Louisiana, Mississippi, Nevada, New Mexico, North Carolina, Oklahoma, South Carolina, Tennessee and Texas. The Company’s primary product categories include:
- Furniture and mattress, including furniture and related accessories for the living room, dining room and bedroom, as well as both traditional and specialty mattresses;
- Home appliance, including refrigerators, freezers, washers, dryers, dishwashers and ranges;
- Consumer electronics, including LCD, LED, 3-D and Ultra HD televisions, Blu-ray players, home theater and portable audio equipment; and
- Home office, including computers, printers and accessories.
Additionally, the Company offers a variety of products on a seasonal basis. 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.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include information concerning the Company’s future financial performance, business strategy, plans, goals and objectives. Statements containing the words “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,” “should,” or the negative of such terms or other similar expressions are generally forward-looking in nature and not historical facts. Although we believe that the expectations, opinions, projections, and comments reflected in these forward-looking statements are reasonable, we can give no assurance that such statements will prove to be correct, and actual results may differ materially. A wide variety of potential risks, uncertainties, and other factors could materially affect the Company’s ability to achieve the results either expressed or implied by the Company’s forward-looking statements including, but not limited to: general economic conditions impacting the Company’s customers or potential customers; the Company’s ability to execute periodic securitizations of future originated loans including the sale of any remaining residual equity on favorable terms; the Company’s ability to continue existing customer financing programs or to offer new customer financing programs; changes in the delinquency status of the Company’s credit portfolio; unfavorable developments in ongoing litigation; increased regulatory oversight; higher than anticipated net charge-offs in the credit portfolio; the success of the Company’s planned opening of new stores; technological and market developments and sales trends for the Company’s major product offerings; the Company’s ability to protect against cyber-attacks or data security breaches and to protect the integrity and security of individually identifiable data of the Company’s customers and employees; the Company’s ability to fund its operations, capital expenditures, debt repayment and expansion from cash flows from operations, borrowings from the Company’s revolving credit facility, and proceeds from accessing debt or equity markets; the ability to continue the Company’s stock repurchase program; and the other risks detailed in the Company’s most recent SEC reports, including but not limited to, the Company’s Annual Report on Form 10-K and the Company’s Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. If one or more of these or other risks or uncertainties materialize (or the consequences of such a development changes), or should our underlying assumptions prove incorrect, actual outcomes may vary materially from those reflected in our forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. We disclaim any intention or obligation to update publicly or revise such statements, whether as a result of new information, future events or otherwise. All forward-looking statements attributable to us, or to persons acting on our behalf, are expressly qualified in their entirety by these cautionary statements.
S.M. Berger & Company
Andrew Berger, 216-464-6400
(APDNW) Enters Diagnostics Market With New DNA Orders
STONY BROOK, NY–(November 02, 2015) – Applied DNA Sciences, Inc. (NASDAQ: APDN) (Twitter: @APDN), a provider of DNA-based anti-counterfeiting and anti-theft technology, product genotyping and product authentication solutions, announced that it has shipped its first orders of DNA used as a diagnostic reagent to reagent suppliers and two international diagnostics customers. The total value of these shipments, which were made in its fiscal 2015 fourth quarter and the current fiscal first quarter, is over $400,000.
On September 11, 2015, APDN announce the acquisition of Vandalia Research, Inc., whose core technology and intellectual property portfolio allows for the large-scale production of specific DNA sequences using polymerase chain reaction (PCR). As part of the acquisition, Applied DNA assumed Vandalia’s backlog of orders.
Dr. James Hayward, CEO of Applied DNA Sciences, stated: “With the fulfillment of these orders, we are already beginning to reap the benefits of the acquisition. Whereas Vandalia’s PCR technology enhances our in-house DNA manufacturing capacity as demand drivers strengthen across key business verticals, it simultaneously provides us entrée into biotechnology, pharmaceutical and diagnostic markets. As we continue to provide contract production of DNA to clients in these markets, we plan to also introduce them to our DNA-based security solutions to protect their products against theft of their IP and the invasion of counterfeits into their supply chains.”
DNA production by PCR is not a broadly available commercial service, especially at large scale. The advantage of PCR-based production is the purity of product compared to the DNA produced by the more commonly available fermentation methods. DNA-based diagnostic reagents may be used in the early detection of cancer, or the diagnosis of genetic, metabolic or infectious diseases. DNA-based therapeutics may be used in gene therapies, DNA vaccines, and other therapies that are generally in the early stage of development. By providing the production of DNA for diagnostics and therapeutics, APDN expects to gain access to pharmaceutic customers who will likely have supply chain concerns, and need to protect themselves against the potential of counterfeit infiltration and comply with FDA efforts to eliminate counterfeits.
“Double-stranded DNA is fundamental to the biotechnology, pharmaceutical and diagnostics markets and we believe our capacity to manufacture it by PCR is unsurpassed in the world,” concluded Dr. Hayward. “Unlike “synthetic DNA,” which is single-stranded, double-stranded DNA provides more informational content and is less subject to degradation, which can lead to an inability to authenticate when the need is critical. Much of our patent portfolio addresses the stability of our double-stranded DNA markers, which, when supplemented by Vandalia’s enhancements to our manufacturing capabilities, delivers cutting-edge value, purity of product and capacity to manufacture to the demanding specifications these markets require. With leadership positions in double-stranded DNA and its manufacture, we believe we are well positioned to succeed in these markets.”
About Applied DNA Sciences
Applied DNA Sciences makes life real and safe by providing biotechnology-driven solutions to help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion. Patented botanical DNA solutions can be used to identify, tag, track, and trace products, to help assure authenticity, traceability and quality of products. SigNature DNA is at the heart of a family of uncopyable, security and authentication solutions such as SigNature® T and fiberTyping®, targeted toward textiles and apparel, DNAnet®, for anti-theft and loss prevention, and digitalDNA®, providing powerful track and trace. All provide a forensic chain of evidence, and can be used to prosecute perpetrators.
Go to adnas.com for more information, events and to learn more about how Applied DNA Sciences makes life real and safe. Common stock listed on NASDAQ under the symbol APDN, and warrants are listed under the symbol APDNW.
Forward Looking Statements
The statements made by APDN in this press release may be “forward-looking” in nature within the meaning of the Private Securities Litigation Act of 1995. Forward-looking statements describe APDN’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of APDN. Actual results could differ materially from those projected due to our short operating history, limited financial resources, limited market acceptance, market competition and various other factors detailed from time to time in APDN’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 15, 2014, as amended on March 6, 2015, and our subsequent quarterly reports on Form 10-Q filed on February 9, 2015, May 11,2015 and August 10, 2015, which are available at www.sec.gov. APDN undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof to reflect the occurrence of unanticipated events, unless otherwise required by law.
Investor contact:
Debbie Bailey
631-240-8817
debbie.bailey@adnas.com
Sanjay M. Hurry, LHA
212-838-3777
shurry@lhai.com
Media contact:
Susan Forman
Dian Griesel Int’l.
212-825-3210,
sforman@dgicomm.com
Web: www.adnas.com
Twitter: @APDN
(OPCO) Q3 2015 Results, Record Net Revenue Near $6M, Net Income Up 428%
FAIRPORT HARBOR, OH–(November 02, 2015) – OurPet’s Company (OTCQX: OPCO) (www.ourpets.com), a leading proprietary pet supply company, today reported record third-quarter revenue of $5.99 million, an increase of 7% from $5.60 million in revenues for the comparable three months of 2014. Net income for the third quarter ended September 30, 2015, increased 428% to $410,450, or $0.02 diluted earnings per share, compared to $77,751, or $0.00, for the year prior.
Dr. Steven Tsengas, President and CEO, commented, “We are pleased with our results for the third quarter in which we achieved record net revenue, gross margins improving to 34%, and net income from operations of almost 11% of sales. We continue to see strong sales growth in the Pet Specialty channel driven by our cat toys and bowls/feeder lines. E-commerce sales rebounded and grew 7% while the Food, Drug, Mass channel slightly decreased; however, we anticipate improved sales as the conversion to the PetZone brand is completed by year end. Unfortunately, with the strengthening of the U.S. dollar, international sales have been negatively impacted particularly in Canada and the United Kingdom.”
Dr. Tsengas continued, “We have expanded and strengthened our relationship with several domestic and international independent sales representative organizations, and have added another experienced salesperson to our staff. With the recent and anticipated introduction of a significant number of new innovative products in all our product categories, we are experiencing robust sales activity. Our Catty Whack™, winner of the SuperZoo ‘Best New Cat Product’ award, is beginning to ship and is receiving strong consumer reaction. We expect to release more information on other major, trend-setting products over the next six months.
“As we have previously communicated, the last five years have been challenging for OurPet’s as we have transitioned from a small- to a medium-sized company poised for accelerated future growth in both revenue and net income. This required large investments in management/operating informational systems; strengthening and, where appropriate, adding management and professional/technical talent; improving warehousing and inventory management efficiencies; strengthening relationships of strategic domestic and overseas suppliers; and strengthening our relationship with our banking resources. We sincerely believe that these improvements will positively impact revenue and profit results going into the fourth quarter of 2015 and beyond.”
2015 Third Quarter Results
Net revenue increased 7% to $5,986,645 for the 2015 third quarter versus the same period last year. The $386,000 increase was attributable to strong sales in the Pet Specialty and Value channels, partially offset by a decrease in the Food, Drug and Mass channel.
Gross Profit was $2,012,177 for the 2015 third quarter compared to $1,640,751 the prior year. Gross profit margin increased 4.3 percentage points to 33.6% for the 2015 third quarter from 29.3% for the same period a year ago due to continuous improvement initiatives, price increases, and product mix.
Income from operations increased to $649,023 for the 2015 third quarter from $152,768 a year ago. This increase was primarily due to higher gross profit and also benefited from lower selling, general, and administrative expenses.
Other income for the 2015 third quarter increased to $14,582 from $6,051 a year ago due to a higher amount of patent infringement settlements.
Income before taxes was almost five times greater at $627,686 for the 2015 third quarter compared to $127,666 a year ago.
Income tax expense for the 2015 third quarter increased to $217,236 from $49,915 a year ago due to the higher income.
Net income increased to $410,450 for the 2015 third quarter from $77,751 last year. Net income per diluted share increased to $0.02 for the third quarter of 2015 from $0.00 a year ago.
EBITDA was $825,696 for the 2015 third quarter versus $323,140 a year ago. A reconciliation of EBITDA to GAAP net income is provided in an attachment to the summary financial statements.
2015 First Nine Months Results
Net revenue increased 6% to $17,170,795 for the first nine months of 2015. The year-over-year increase was due to strong Pet Specialty sales, especially in the bowls and feeders category.
Gross profit increased 15% to $5,424,591 for the first nine months of 2015 versus the prior year. Gross profit margin increased 2.5 percentage points to 31.6% for the first nine months of 2015 from 29.1% the prior year due to the same factors that benefited the 2015 third quarter results.
Income from operations increased 143% to $1,427,797 for the first nine months of 2015, which was attributable to higher gross profit and lower selling, general, and administrative expenses.
Other income decreased to $40,582 for the first nine months of 2015 from $77,713 for the same period last year due to a greater amount of patent infringement settlements in 2014.
Income before taxes increased to $1,383,158 for the first nine months of 2015 compared to $566,658 for the same period a year ago.
Income tax expense was $496,839 for the first nine months of 2015 compared to $206,723 the prior year.
Net income for the first nine months of 2015 increased 146% to $886,319 from $359,935 for the same period in 2014. Net income per share increased to $0.04 for the first nine months of 2015 from $0.02 last year.
EBITDA increased 72% to $1,984,688 the first nine months of 2015 compared to $1,153,656 the prior year. A reconciliation of EBITDA to GAAP Net Income is provided in an attachment to the summary financial statements.
The Current Ratio improved to 5.61, reflecting or strong liquidity, while Stockholders’ Equity improved by $904,319 or 12.1% over the comparable date last year.
About OurPet’s Company
OurPet’s Company designs, produces and markets a broad line of innovative, high-quality accessory and consumable pet products in the U.S. and overseas. Investors and customers may visit www.ourpets.com for more information about our company and its products. OurPet’s websites include www.petzonebrand.com and www.ourpets.com.
Forward-Looking Statements
Certain of the matters set forth in this press release are forward-looking and involve a number of risks and uncertainties. Among the factors that could cause actual results to differ materially are the following: business conditions; growth in the industry; general economic conditions; addition or loss of significant customers; the loss of key personnel; product development; competition; risks of doing business abroad; foreign government regulations; fluctuations in foreign currency rates; rising costs for raw materials and sources of supply that may be limited or unavailable from time to time; the timing of orders booked; and the other risks that are described from time to time in OurPet’s SEC reports.
OURPET’S COMPANY AND SUBSIDIARIES | ||||||||||||||||||
CONSOLIDATED OPERATING RESULTS | ||||||||||||||||||
For the Three Months Ended | For the Nine Months Ended | |||||||||||||||||
September 30, | September 30, | |||||||||||||||||
2015 | 2014 | 2015 | 2014 | |||||||||||||||
Net revenue | $ | 5,986,645 | $ | 5,601,011 | $ | 17,170,795 | $ | 16,175,692 | ||||||||||
Cost of goods sold | 3,974,468 | 3,960,260 | 11,746,204 | 11,462,593 | ||||||||||||||
Gross profit on sales | 2,012,177 | 1,640,751 | 5,424,591 | 4,713,099 | ||||||||||||||
Selling, general and administrative expenses | 1,363,154 | 1,487,983 | 3,996,794 | 4,126,635 | ||||||||||||||
Income from operations | 649,023 | 152,768 | 1,427,797 | 586,464 | ||||||||||||||
Other (income) and expense, net | (14,582 | ) | (6,051 | ) | (40,582 | ) | (77,713 | ) | ||||||||||
Interest expense | 35,919 | 31,153 | 85,221 | 97,519 | ||||||||||||||
Income before taxes | 627,686 | 127,666 | 1,383,158 | 566,658 | ||||||||||||||
Income Tax expense | 217,236 | 49,915 | 496,839 | 206,723 | ||||||||||||||
Net Income | $ | 410,450 | $ | 77,751 | $ | 886,319 | $ | 359,935 | ||||||||||
Basic and Diluted Net Income Per Common Share After Dividend Requirements For Preferred Stock | $ | 0.02 | $ | 0.00 | $ | 0.04 | $ | 0.02 | ||||||||||
Weighted average number of common shares outstanding used to calculate basic earnings per share | 17,562,239 | 17,056,910 | 17,558,085 | 16,884,581 | ||||||||||||||
Weighted average number of common and equivalent shares outstanding used to calculate diluted earnings per share | 19,824,793 | 18,037,565 | 19,220,115 | 18,160,977 | ||||||||||||||
OURPET’S COMPANY AND SUBSIDIARIES | ||||||||
CONSOLIDATED BALANCE SHEETS | ||||||||
September 30, | December 31, | |||||||
2015 | 2014 | |||||||
ASSETS | ||||||||
Cash and equivalents | $ | 101,775 | $ | 192,448 | ||||
Receivables, net | 4,048,759 | 3,116,448 | ||||||
Inventories, net | 7,802,675 | 6,894,115 | ||||||
Prepaid expenses | 467,126 | 478,593 | ||||||
Total current assets | 12,420,335 | 10,681,604 | ||||||
LONG TERM ASSETS | ||||||||
Property and equipment, net | 1,867,252 | 1,769,548 | ||||||
Amortizable intangible assets, net | 361,259 | 384,063 | ||||||
Non amortizable Intangible Assets | 461,000 | 461,000 | ||||||
Goodwill | 67,511 | 67,511 | ||||||
Deposits and Other assets | 18,003 | 18,003 | ||||||
Total long term assets | 2,775,025 | 2,700,125 | ||||||
Total assets | $ | 15,195,360 | $ | 13,381,729 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Current maturities of long-term debt | 311,470 | 601,632 | ||||||
Accounts payable | 1,244,885 | 1,489,982 | ||||||
Accrued expenses | 656,652 | 565,491 | ||||||
Total current liabilities | 2,213,007 | 2,657,105 | ||||||
LONG TERM LIABILITIES | ||||||||
Long-term debt – less current portion above | 938,894 | 119,780 | ||||||
Revolving line of credit | 3,473,032 | 2,862,032 | ||||||
Deferred income taxes | 204,947 | 281,651 | ||||||
Total long term liabilities | 4,616,873 | 3,263,463 | ||||||
Total liabilities | 6,829,880 | 5,920,568 | ||||||
Stockholders’ Equity | 8,365,480 | 7,461,161 | ||||||
Total liabilities and stockholders’ equity | $ | 15,195,360 | $ | 13,381,729 | ||||
OURPET’S COMPANY AND SUBSIDIARIES | ||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
September 30, | December 31, | |||||||
2015 | 2014 | |||||||
Unaudited | ||||||||
ASSETS | ||||||||
CURRENT ASSETS | ||||||||
Cash and cash equivalents | $ | 101,775 | $ | 192,448 | ||||
Accounts receivable – trade, less allowance for doubtful accounts of $37,824 and $39,539 | 4,048,759 | 3,116,448 | ||||||
Inventories net of reserve | 7,802,675 | 6,894,115 | ||||||
Prepaid expenses | 467,126 | 478,593 | ||||||
Total current assets | 12,420,335 | 10,681,604 | ||||||
PROPERTY AND EQUIPMENT | ||||||||
Computers and office equipment | 1,020,239 | 883,163 | ||||||
Warehouse equipment | 585,815 | 567,816 | ||||||
Leasehold improvements | 289,217 | 276,952 | ||||||
Tooling | 4,207,203 | 3,885,401 | ||||||
Construction in progress | 222,573 | 157,031 | ||||||
Total | 6,325,047 | 5,770,363 | ||||||
Less accumulated depreciation | 4,457,795 | 4,000,815 | ||||||
Net property and equipment | 1,867,252 | 1,769,548 | ||||||
OTHER ASSETS | ||||||||
Amortizable Intangible Assets, less amortization of $476,677 and $417,349 | 361,259 | 384,063 | ||||||
Intangible Assets | 461,000 | 461,000 | ||||||
Goodwill | 67,511 | 67,511 | ||||||
Deposits and other assets | 18,003 | 18,003 | ||||||
Total other assets | 907,773 | 930,577 | ||||||
Total assets | $ | 15,195,360 | $ | 13,381,729 | ||||
The accompanying notes are an integral part of the condensed consolidated financial statements.
OURPET’S COMPANY AND SUBSIDIARIES | ||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS (CONTINUED) | ||||||||
September 30, | December 31, | |||||||
2015 | 2014 | |||||||
Unaudited | ||||||||
LIABILITIES | ||||||||
CURRENT LIABILITIES | ||||||||
Current maturities of long-term debt | 311,470 | 601,632 | ||||||
Accounts payable – trade | 1,244,885 | 1,489,982 | ||||||
Other accrued expenses | 656,652 | 565,491 | ||||||
Total current liabilities | 2,213,007 | 2,657,105 | ||||||
LONG-TERM LIABILITIES | ||||||||
Long-term debt – less current portion above | 938,894 | 119,780 | ||||||
Revolving Line of Credit | 3,473,032 | 2,862,032 | ||||||
Deferred Income Taxes | 204,947 | 281,651 | ||||||
Total long term liabilities | 4,616,873 | 3,263,463 | ||||||
Total liabilities | 6,829,880 | 5,920,568 | ||||||
STOCKHOLDERS’ EQUITY | ||||||||
COMMON STOCK, | ||||||||
no par value; 50,000,000 shares authorized, 17,562,239 and 16,657,660 shares issued and outstanding at September 30, 2015 and December 31, 2014 respectively | 5,031,766 | 5,031,766 | ||||||
CONVERTIBLE PREFERRED STOCK, | ||||||||
no par value; convertible into Common Stock at the rate of 10 common shares for each preferred share; 4,825,000 shares authorized, 63,500 shares issued and outstanding at September 30, 2015 and December 31, 2014 | 579,850 | 579,850 | ||||||
Series 2009 no par value; convertible into Common Stock at the rate of 10 common shares for each preferred share; 175,000 shares authorized, 123,616 shares issued and outstanding at September 30, 2015 and December 31, 2014 | 865,312 | 865,312 | ||||||
PAID-IN CAPITAL | 71,307 | 53,307 | ||||||
ACCUMULATED EARNINGS | 1,817,245 | 930,926 | ||||||
Total stockholders’ equity | 8,365,480 | 7,461,161 | ||||||
Total liabilities and stockholders’ equity | $ | 15,195,360 | $ | 13,381,729 | ||||
The accompanying notes are an integral part of the consolidated financial statements.
OURPETS COMPANY AND SUBSIDIARIES | |||||||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||
(Unaudited) | |||||||||||||||||
For the Three Months Ended September 30, | For the Nine Months Ended September 30, | ||||||||||||||||
2015 | 2014 | 2015 | 2014 | ||||||||||||||
Net revenue | $ | 5,986,645 | $ | 5,601,011 | $ | 17,170,795 | $ | 16,175,692 | |||||||||
Cost of goods sold | 3,974,468 | 3,960,260 | 11,746,204 | 11,462,593 | |||||||||||||
Gross profit on sales | 2,012,177 | 1,640,751 | 5,424,591 | 4,713,099 | |||||||||||||
Selling, general and administrative expenses | 1,363,154 | 1,487,983 | 3,996,794 | 4,126,635 | |||||||||||||
Income from operations | 649,023 | 152,768 | 1,427,797 | 586,464 | |||||||||||||
Other income | (14,582 | ) | (6,051 | ) | (40,582 | ) | (77,713 | ) | |||||||||
Interest expense | 35,919 | 31,153 | 85,221 | 97,519 | |||||||||||||
Income before income taxes | 627,686 | 127,666 | 1,383,158 | 566,658 | |||||||||||||
Income tax expense | 217,236 | 49,915 | 496,839 | 206,723 | |||||||||||||
Net income | $ | 410,450 | $ | 77,751 | $ | 886,319 | $ | 359,935 | |||||||||
Basic and Diluted Earnings Per Common Share After Dividend Requirements For Preferred Stock: | |||||||||||||||||
Net Income | $ | 0.02 | $ | 0.00 | $ | 0.04 | $ | 0.02 | |||||||||
Weighted average number of common shares outstanding used to calculate basic earnings per share | 17,562,239 | 17,056,910 | 17,558,085 | 16,884,581 | |||||||||||||
Weighted average number of common and equivalent shares outstanding used to calculate diluted earnings per share | 19,824,793 | 18,037,565 | 19,220,115 | 18,160,977 | |||||||||||||
The accompanying notes are an integral part of the consolidated financial statements.
OURPET’S COMPANY AND SUBSIDIARIES |
CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY (Unaudited) |
FOR THE NINE MONTHS ENDED September 30, 2015 |
Preferred Stock | Series 2009 Preferred Stock | Common Stock | ||||||||||||||||||||||
Number of Shares |
Amount | Number of Shares |
Amount | Number of Shares |
Amount | Paid-In Capital |
Accumulated Earnings |
Total Stockholders’ Equity |
||||||||||||||||
Balance at December 31, 2014 | 63,500 | $ | 579,850 | 123,616 | $ | 865,312 | 17,553,007 | $ | 5,031,766 | $ | 53,307 | $ | 930,926 | $ | 7,461,161 | |||||||||
Common Stock issued upon exercise of stock options | – | – | – | – | 9,232 | – | – | – | – | |||||||||||||||
Net income | – | – | – | – | – | – | – | 886,319 | 886,319 | |||||||||||||||
Stock-Based compensation expense | – | – | – | – | – | – | 18,000 | – | 18,000 | |||||||||||||||
Balance at September 30, 2015 (unaudited) | 63,500 | $ | 579,850 | 123,616 | $ | 865,312 | 17,562,239 | $ | 5,031,766 | $ | 71,307 | $ | 1,817,245 | $ | 8,365,480 | |||||||||
The accompanying notes are an integral part of the condensed consolidated financial statements.
OURPET’S COMPANY AND SUBSIDIARIES | ||||||||||||
CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||||||||||
(Unaudited) | ||||||||||||
For the Nine Months Ended | ||||||||||||
September 30, | ||||||||||||
2015 | 2014 | |||||||||||
CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||||||
Net income | $ | 886,319 | $ | 359,935 | ||||||||
Adjustments to reconcile net income to net cash used in operating activities: | ||||||||||||
Loss on Disposal of Fixed Assets | 20,657 | 12,323 | ||||||||||
Depreciation expense | 456,981 | 430,988 | ||||||||||
Amortization expense | 59,328 | 58,491 | ||||||||||
Stock option expense | 18,000 | 9,000 | ||||||||||
(Increase) decrease in assets: | ||||||||||||
Accounts receivable – trade | (932,311 | ) | (417,090 | ) | ||||||||
Inventories | (908,560 | ) | (1,848,425 | ) | ||||||||
Prepaid expenses | 11,467 | 33,901 | ||||||||||
Amortizable Intangible Asset Additions | (36,524 | ) | (67,154 | ) | ||||||||
Increase (decrease) in liabilities: | ||||||||||||
Accounts payable – trade | (245,097 | ) | 933,303 | |||||||||
Accrued expenses | 91,161 | (415,195 | ) | |||||||||
Deferred tax liabilities | (76,704 | ) | (58,234 | ) | ||||||||
Net cash used in operating activities | (655,284 | ) | (968,157 | ) | ||||||||
CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||||||
Acquisition of property and equipment | (490,341 | ) | (398,816 | ) | ||||||||
Net cash used in investing activities | (490,341 | ) | (398,816 | ) | ||||||||
CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||||||
Principal borrowings of long-term debt | 1,000,000 | – | ||||||||||
Principal payments on long-term debt | (556,048 | ) | (335,289 | ) | ||||||||
Borrowings on bank line of credit | 611,000 | 1,649,000 | ||||||||||
Issuances of Common Stock | – | 72,500 | ||||||||||
Net cash provided by financing activities | 1,054,952 | 1,386,211 | ||||||||||
Net increase (decrease) in cash | (90,673 | ) | 19,238 | |||||||||
CASH AT BEGINNING OF PERIOD | 192,448 | 57,975 | ||||||||||
CASH AT END OF PERIOD | $ | 101,775 | $ | 77,213 | ||||||||
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION | ||||||||||||
Interest paid | $ | 126,552 | $ | 81,856 | ||||||||
Income taxes paid | $ | 472,150 | $ | 425,466 | ||||||||
SUPPLEMENTAL DISCLOSURE OF NON CASH TRANSACTIONS | ||||||||||||
Non cash exercise of stock options/ warrants | $ | 6,933 | $ | 539,128 | ||||||||
Tooling Obtained through Asset Purchase | $ | 85,000 | $ | – | ||||||||
The accompanying notes are an integral part of the consolidated financial statements.
OURPET’S COMPANY AND SUBSIDIARIES | |||||||||||||||
STATEMENT OF COMPUTATION OF NET INCOME PER SHARE | |||||||||||||||
For the Three Months Ended | For the Nine Months Ended | ||||||||||||||
September 30, | September 30, | ||||||||||||||
2015 | 2014 | 2015 | 2014 | ||||||||||||
Net income (loss) | $ | 410,450 | $ | 77,751 | $ | 886,319 | $ | 359,935 | |||||||
Preferred Stock dividend requirements | – | (24,610 | ) | (35,621 | ) | (73,028 | ) | ||||||||
Net income (loss) attributable to common stockholders | $ | 410,450 | $ | 53,141 | $ | 850,698 | $ | 286,907 | |||||||
Basic weighted average number of common shares outstanding | 17,562,239 | 17,056,910 | 17,558,085 | 16,884,581 | |||||||||||
Preferred Stock Common Share Equivalents | 1,871,160 | – | 1,236,160 | – | |||||||||||
Dilutive Stock Options outstanding for the Period | 97,973 | 380,077 | 111,733 | 594,024 | |||||||||||
Dilutive Warrants outstanding for the Period | 293,420 | 600,578 | 314,137 | 682,372 | |||||||||||
Diluted weighted average number of common and equivalent shares outstanding | 19,824,793 | 18,037,565 | 19,220,115 | 18,160,978 | |||||||||||
Basic and Diluted Net income (loss) per common share | $ | 0.02 | $ | 0.00 | $ | 0.04 | $ | 0.02 | |||||||
EBITDA Q3’15 | |||||||||||||
EBITDA | Q3’15 | Q3’14 | 1st nine months 2015 |
1st nine months 2014 |
|||||||||
Net Income | $ | 410,450 | $ | 77,751 | $ | 886,319 | $ | 359,935 | |||||
Interest | 35,919 | 31,153 | 85,221 | 97,519 | |||||||||
Tax Expense | 217,236 | 49,915 | 496,839 | 206,723 | |||||||||
Depreciation | 143,135 | 143,977 | 456,981 | 430,988 | |||||||||
Amortization | 18,956 | 20,344 | 59,328 | 58,491 | |||||||||
Total EBITDA | $ | 825,696 | $ | 323,140 | $ | 1,984,688 | $ | 1,153,656 | |||||
The above table reconciles the Company’s disclosure of Net Income per GAAP with the non GAAP financial measure EBITDA (Earnings Before Interest, Taxes, Depreciation and Amortization). As the investment community has often requested the EBITDA calculation to help them evaluate performance, Management has chosen to provide this disclosure. Although EBITDA is widely used in the investment community as a benchmark to reflect operating performance, financing capability and liquidity, it is not regarded as a measure of operating performance and liquidity under generally accepted accounting principles (“GAAP”). It also does not represent cash flows from operating activities. In addition, the Company’s EBITDA may not be comparable to similar indicators provided by other companies. The Presentation of this additional information is not meant to be considered in isolation or as a substitute for net income (loss), or any component thereof, in accordance with GAAP.
For further information, contact:
OurPet’s Company
Dr. Steven Tsengas
CEO
(440) 343-6500, x111
DreamTeamNetwork
Austin, Texas
www.DreamTeamNetwork.com
512.758.8877 Office
Editor@DreamTeamNetwork.com
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