News Article | November 7, 2016
MORRISTOWN, N.J., Nov. 07, 2016 (GLOBE NEWSWIRE) -- Pernix Therapeutics Holdings, Inc. (NASDAQ:PTX), a specialty pharmaceutical company with a focus on Pain and CNS conditions, today announced the appointment of Graham G. Miao, Ph.D. and Dennis H. Langer, M.D., J.D. to its Board of Directors, effective immediately. The Board also determined that Dr. Langer is an independent director and appointed him as chairperson of the Compensation Committee and as a member of the Audit and Nominating Committees. Accordingly, Pernix regained compliance with NASDAQ Listing Rule 5605(c)(2)(A), which requires Pernix to have at least three independent directors on its Audit Committee for continued listing on The NASDAQ Global Market. “I’m pleased to welcome Dr. Miao and Dr. Langer to the Board,” said John Sedor, Chairman and Chief Executive Officer. “Dr. Miao and Dr. Langer are industry leaders. Their breadth of knowledge and experience will provide invaluable insight to Pernix as we move forward with the vision that I outlined when I first took over as Chief Executive Officer – to grow our current brands, pursue other growth opportunities and, ultimately, maximize shareholder value.” Dr. Miao has served as Pernix’s President and Chief Financial Officer since July 2016. He was Senior Advisor to the Pernix interim CEO and Board of Directors from May 2016 to July 2016. Prior to joining Pernix, Dr. Miao served as Executive Vice President, Chief Financial Officer of PDI, Inc., a NASDAQ listed healthcare commercialization and molecular diagnostic company, from October 2014 until March 2016. In this role, he helped achieve double-digit revenue growth and lead the successful sale of PDI's contract sales business to Publicis Healthcare. From September 2011 to September 2014, Dr. Miao served as Executive Vice President and Chief Financial Officer and held the additional role as Co-President and Co-Chief Executive Officer from September 2013 to September 2014 of Delcath Systems, Inc., a NASDAQ traded specialty pharmaceutical and medical device company focused on cancer treatment. From September 2009 until September 2011, Dr. Miao served as Chief of Staff for the Global CFO Organization at Dun & Bradstreet Corporation. Previously, Dr. Miao held senior management roles including EVP and CFO at Pagoda Pharmaceuticals and Vice President of Strategic Planning & Financial Analysis at Symrise Inc. He also worked at Schering-Plough Corporation, serving as division CFO for the company's $3 billion primary care pharmaceuticals franchise. Dr. Miao held management roles at Pharmacia Corporation, including division CFO for the company's $1.3 billion Global Oncology franchise where he led finance teams across marketing, sales, medical affairs, business development, and mergers & acquisitions. Earlier in his career, Dr. Miao worked as a biotechnology equity analyst at J.P. Morgan and a research scientist at Roche. Dr. Miao earned an M.B.A. in Finance and a Ph.D., M.Phil., M.A. in Biological Sciences from Columbia University, an M.S. in Molecular Biology from Arizona State University, and a B.S. in Biology from Fudan University. Dr. Langer has served as director of several biotechnology, specialty pharmaceutical, and diagnostic companies, and has been CEO and/or co-founder of several health care companies. From January 2013 to July 2014 he served as Chairman and Chief Executive Officer of AdvanDx, Inc., a healthcare solutions company. From 2005 to 2010, Dr. Langer served as a Managing Partner of Phoenix IP Ventures, a private equity/venture capital firm specializing in life sciences. Previously, he was President, North America, of Dr. Reddy’s Laboratories, Limited, a multinational pharmaceutical company. From September 1994 until January 2004, Dr. Langer held several high-level positions at GlaxoSmithKline plc, and its predecessor, SmithKline Beecham, including most recently as a Senior Vice President of Research and Development. Prior to SmithKline Beecham, Dr. Langer was President and CEO of Neose Technologies, Inc. and before that held R&D and marketing positions at pharmaceutical companies Eli Lilly and Company, Abbott Laboratories and G. D. Searle & Company. At the beginning of his career, he was a Chief Resident at Yale University School of Medicine, and held clinical fellowships at Harvard Medical School and the National Institutes of Health. Dr. Langer currently serves as a Director of Myriad Genetics, Inc., Dicerna Pharmaceuticals, Inc., and several private companies. Dr. Langer served as a Director of several pharmaceutical and biotechnology companies, including Auxilium Pharmaceuticals, Inc., Ception Therapeutics, Inc. (acquired by Cephalon, Inc.), Cytogen Corporation, (acquired by EUSA Pharma, Inc.) Delcath Systems, Inc., Myrexis, Inc. Pharmacopeia, Inc. (acquired by Ligand Pharmaceuticals, Inc.), Sirna Therapeutics, Inc. (acquired by Merck & Co., Inc.), and Transkaryotic Therapies, Inc. (acquired by Shire plc). Dr. Langer is a Clinical Professor, Department of Psychiatry, Georgetown University School of Medicine. Dr. Langer received a J.D. from Harvard Law School, a M.D. from Georgetown University School of Medicine, and a B.A. in Biology from Columbia University. About Pernix Therapeutics Pernix Therapeutics is a specialty pharmaceutical business with a focus on acquiring, developing and commercializing prescription drugs primarily for the U.S. market. The Company targets underserved therapeutic areas such as CNS, including neurology and pain management, and has an interest in expanding into additional specialty segments. The Company promotes its branded products to physicians through its integrated Pernix sales force and markets its generic portfolio through its wholly owned subsidiaries, Macoven Pharmaceuticals, LLC and Cypress Pharmaceutical, Inc. To learn more about Pernix Therapeutics, visit www.pernixtx.com.
News Article | December 19, 2016
VALLEY FORGE, Pa.--(BUSINESS WIRE)--AmerisourceBergen Corporation (NYSE: ABC) today announced that Keri Mattox will join the Company as Vice President, Corporate & Investor Relations, effective January 3, 2017. In this role, Ms. Mattox will assume responsibility for the Company’s relationships with the analyst and investor community, reporting directly to Tim G. Guttman, Executive Vice President and Chief Financial Officer. Ms. Mattox succeeds Barbara A. Brungess, currently Vice President, Corporate & Investor Relations, who has announced that she is leaving the Company, effective December 31, 2016, to pursue other opportunities. “ I am delighted to have Keri lead our investor relations efforts going forward. In addition to the investor relations and healthcare industry experience she brings to AmerisourceBergen, Keri has established a great reputation and many strong relationships across the financial community,” said Steven H. Collis, Chairman, President and Chief Executive Officer of AmerisourceBergen. “ We look forward to Keri’s contributions and support as AmerisourceBergen continues to pursue its long-term growth strategies in the global pharmaceutical supply chain.” “ I also want to thank Barbara for her leadership and dedication to AmerisourceBergen during the 16 years she has been with the Company,” Collis continued. “ Barbara has made a significant impact on AmerisourceBergen during her tenure and helped us build and solidify relationships with the investment community. Her integrity, sound judgment and industry expertise have served AmerisourceBergen and our shareholders extremely well. It has been a pleasure working with Barbara, and we wish her all the best.” Ms. Mattox brings over 15 years of investor relations and corporate communications experience spanning both corporate roles and public relations firms. She has significant experience within the specialty, generics and biotech pharmaceutical sectors. Most recently, Ms. Mattox served as Senior Vice President, Investor Relations & Corporate Public Affairs with Endo International, a role she assumed in 2015 following Endo’s acquisition of Auxilium Pharmaceuticals, where she led the investor relations function. At Endo, she was responsible for investor relations, corporate communications and government affairs. Ms. Mattox started her career in journalism with positions at the Washington Post and Hearst Newspapers before transitioning into public relations and then the pharmaceutical industry. Ms. Mattox graduated magna cum laude with a bachelor’s degree in Political Science from Boston University and has her master’s degree in Journalism from the University of Maryland. As of January 3, 2017, Ms. Mattox can be reached at AmerisourceBergen at 610-576-7801 and email@example.com. In the interim period, Investor Relations questions can be directed to Bennett Murphy, Manager, Corporate & Investor Relations at 610-727-3693 and firstname.lastname@example.org. AmerisourceBergen is one of the largest global pharmaceutical sourcing and distribution services companies, helping both healthcare providers and pharmaceutical and biotech manufacturers improve patient access to products and enhance patient care. With services ranging from drug distribution and niche premium logistics to reimbursement and pharmaceutical consulting services, AmerisourceBergen delivers innovative programs and solutions across the pharmaceutical supply channel in human and animal health. With over $145 billion in annual revenue, AmerisourceBergen is headquartered in Valley Forge, PA, and employs approximately 19,000 people. AmerisourceBergen is ranked #12 on the Fortune 500 list. For more information, go to www.amerisourcebergen.com. Certain of the statements contained in this press release are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Words such as "expect," "likely," "outlook," "forecast," "would," "could," "should," "can," "will," "project," "intend," "plan," "continue," "sustain," "synergy," "on track," "believe," "seek," "estimate," "anticipate," "may," "possible," "assume," variations of such words, and similar expressions are intended to identify such forward-looking statements. These statements are based on management's current expectations and are subject to uncertainty and change in circumstances. These statements are not guarantees of future performance and are based on assumptions that could prove incorrect or could cause actual results to vary materially from those indicated. Among the factors that could cause actual results to differ materially from those projected, anticipated, or implied are the following: competition; industry consolidation of both customers and suppliers resulting in increasing pressure to reduce prices for our products and services; changes in pharmaceutical market growth rates; unfavorable trends in brand and generic pharmaceutical pricing, including in rate or frequency of price inflation or deflation; substantial defaults in payment, material reduction in purchases by or the loss, bankruptcy or insolvency of a major customer; changes to the customer or supplier mix; the retention of key customer or supplier relationships under less favorable economics or the adverse resolution of any contract or other dispute with customers or suppliers; changes to customer or supplier payment terms; the disruption of AmerisourceBergen's cash flow and ability to return value to its stockholders in accordance with its past practices; risks associated with the strategic, long-term relationship between Walgreens Boots Alliance, Inc. and AmerisourceBergen, including with respect to the pharmaceutical distribution agreement and/or the global sourcing arrangement; changes in the United States healthcare and regulatory environment, including changes that could impact prescription drug reimbursement under Medicare and Medicaid; increasing governmental regulations regarding the pharmaceutical supply channel and pharmaceutical compounding; federal and state government enforcement initiatives to detect and prevent suspicious orders of controlled substances and the diversion of controlled substances; federal and state prosecution of alleged violations of related laws and regulations, and any related litigation, including shareholder derivative lawsuits or other disputes relating to our distribution of controlled substances; increased federal scrutiny and qui tam litigation for alleged violations of fraud and abuse laws and regulations and/or any other laws and regulations governing the marketing, sale, purchase and/or dispensing of pharmaceutical products or services and any related litigation; material adverse resolution of pending legal proceedings; declining reimbursement rates for pharmaceuticals; the acquisition of businesses that do not perform as expected, or that are difficult to integrate or control, including the integration of PharMEDium, or the inability to capture all of the anticipated synergies related thereto; regulatory action in connection with the production, labeling or packaging of products compounded by our compounded sterile preparations (CSP) business; declining economic conditions in the United States and abroad; financial market volatility and disruption; the loss, bankruptcy or insolvency of a major supplier; interest rate and foreign currency exchange rate fluctuations; managing foreign expansion, including non-compliance with the U.S. Foreign Corrupt Practices Act, anti-bribery laws and economic sanctions and import laws and regulations; malfunction, failure or breach of sophisticated information systems to operate as designed; risks generally associated with data privacy regulation and the international transfer of personal data; changes in tax laws or legislative initiatives that could adversely affect AmerisourceBergen's tax positions and/or AmerisourceBergen's tax liabilities or adverse resolution of challenges to AmerisourceBergen's tax positions; natural disasters or other unexpected events that affect AmerisourceBergen's operations; the impairment of goodwill or other intangible assets, resulting in a charge to earnings; and other economic, business, competitive, legal, tax, regulatory and/or operational factors affecting AmerisourceBergen's business generally. Certain additional factors that management believes could cause actual outcomes and results to differ materially from those described in forward-looking statements are set forth (i) in Item 1A (Risk Factors) in the Company’s Annual Report on Form 10-K for the fiscal year ended September 30, 2016 and elsewhere in that report and (ii) in other reports filed by the Company pursuant to the Securities Exchange Act.
Gelbard M.K.,Urology Associates Medical Group |
Chagan L.,Auxilium Pharmaceuticals |
Tursi J.P.,Auxilium Pharmaceuticals
Journal of Sexual Medicine | Year: 2015
Introduction: The conception of collagenase Clostridium histolyticum (CCH) as treatment for Peyronie's disease (PD) was a vital first step in providing a nonsurgical, minimally invasive FDA-approved treatment for men with PD. Aim: To review the origins, clinical research history, and ultimately FDA approval of collagenase as PD treatment. Methods: A PubMed search using (Peyronie's or Peyronie) AND collagenase, and limited to clinical research studies, returned nine papers that were examined in the current review. Results: Collagenase as a PD treatment arose in response to a lack of effective nonsurgical treatments and the incomplete understanding of underlying PD etiology. Awareness of dense collagen in PD scarring and parallel initial exploration of collagenase to treat herniated lumbar discs coincided with and inspired laboratory-based investigation of collagenase effects on excised PD plaque tissue. The foundational conceptual work and the critical development of purified injectable collagenase allowed the pursuit of clinical studies. Progression of clinical studies into large-scale robust trials culminated in two important outcomes: development of the first validated, PD-specific measure of psychosexual function, the Peyronie's Disease Questionnaire, and the first FDA-approved treatment for PD. Conclusions: Collagenase therapy began as an attempt to modify the structure of PD-related tunica albuginea scarring, despite the lack of a fundamental understanding of the scar's origin. If we wish to advance PD treatment beyond this first effective step, the future needs to bring us full circle to the starting point: We need a greater understanding of the control of collagen deposition and wound healing in men with PD. © 2015 International Society for Sexual Medicine.
Hellstrom W.J.G.,Tulane University |
Feldman R.,Connecticut Clinical Research Center and Urology Specialists |
Rosen R.C.,New England Research Institutes, Inc. |
Smith T.,Auxilium Pharmaceuticals |
And 2 more authors.
Journal of Urology | Year: 2013
Purpose: We validated the Peyronie's Disease Questionnaire (http://www.auxilium.com/PDQ), a 15-question self-reported survey that measures the impact and severity of Peyronie's disease symptoms in 3 domains, including 1) psychological and physical symptoms, 2) penile pain and 3) symptom bother. Materials and Methods: We used baseline data from 2 phase 3 clinical trials (334 and 345 patients, respectively) of collagenase clostridium histolyticum treatment for Peyronie's disease associated penile curvature and bother. Collected data included PDQ domain scores, International Index of Erectile Function scores, objective penile curvature measures and patient reported Peyronie's disease symptom severity. Psychometric analyses included confirmatory factor analysis, inter-item reliability, and tests of convergent and discriminant validity, all related to the overall construct validity of the scale. Results: Confirmatory factor analysis supported the conceptual framework of the PDQ with 3 confirmed subdomains. Each scale showed good consistency, ie internal reliability (each Cronbach α >0.70). Convergent and discriminant validity were noted in the pattern of associations between PDQ domains and other Peyronie's disease measures. PDQ domain scores significantly differed between patients with vs without erectile dysfunction and between patients with vs without Peyronie's disease related symptom distress, further supporting PDQ construct validity. Conclusions: This study confirms the conceptual framework, factor structure, and convergent and discriminant validity of the PDQ psychological and physical symptoms, penile pain, and symptom bother domains. Used in conjunction with objective penile curvature measurements, the PDQ can serve as a valuable diagnostic tool or outcome measure to assess treatment related improvements in Peyronie's disease symptoms. © 2013 American Urological Association Education and Research, Inc.
Coyne K.S.,Outcomes Research |
Currie B.M.,Outcomes Research |
Thompson C.L.,Outcomes Research |
Smith T.M.,Auxilium Pharmaceuticals
Journal of Sexual Medicine | Year: 2015
Introduction: In order to reliably assess treatment effectiveness, patient-reported outcome instruments must demonstrate adequate psychometric properties. Aim: To assess the responsiveness of the Peyronie's Disease Questionnaire (PDQ) using data from two Phase 3 trials of collagenase clostridium histolyticum for Peyronie's disease (PD). Methods: Both trials recruited adult males with PD who were in a stable relationship with a female partner for at least 3 months. Patients completed the PDQ, International Index of Erectile Function (IIEF), and a global assessment of PD (GAPD) questionnaire at baseline and Weeks 24 and 52. Anchor- and distribution-based methods were used to evaluate the responsiveness of the PDQ. Main Outcome Measure: Peyronie's Disease Questionnaire. Results: The number of men available with baseline and Week 52 data was 267 for Study 1 and 270 for Study 2. The mean age was 58.0 for Study 1 and 57.4 for Study 2; the majority were white (95.2% and 97.3%, respectively). Mean PDQ subscale change scores from baseline to Week 52 for both studies ranged from -1.5 to -4.6 (P<0.0001). In Study 1, effect sizes were moderate to large on the Psychological and Physical Symptoms (-0.56) and Symptom Bother subscales (-0.84). For patients with penile pain at baseline, the effect size was large (-1.05) for the Penile Pain subscale. Similar effect sizes were seen in Study 2. The Psychological and Physical Symptoms and Symptom Bother subscales significantly discriminated patient improvement ratings of GAPD and degree of penile curvature at Weeks 24 and 52. Conclusions: The PDQ is highly responsive to change in men with PD. Coyne KS, Currie BM, Thompson CL, and Smith TM. Responsiveness of the Peyronie's Disease Questionnaire (PDQ). J Sex Med 2015;12:1072-1079. © 2015 International Society for Sexual Medicine.
Auxilium Pharmaceuticals | Date: 2014-04-17
The present invention is directed to a method of treating or reducing EFP in a patient comprising administering one or multiple low dose injections of collagenase to an area affected by EFP. The invention encompasses methods wherein the dose of collagenase per injection is between about 50 to about 200 ABC units and/or wherein the concentration of collagenase is between about 50 to about 2000 ABC units/milliliter (ml).
News Article | October 24, 2014
Whichever party is in the majority in the House and Senate after the November elections, the next Congress should make repairing our broken tax code a bipartisan priority. That fix must be comprehensive; more tinkering won't work. Last month, Treasury Secretary Jack Lew unveiled proposed regulations intended to bring an end to so-called inversions -- which allow a U.S.-based company to change its address to a foreign country to avoid our high tax rates and escape our uncompetitive tax code. Rather than addressing the flaws in our tax system that drive our companies overseas, the new regulations try to hem businesses into an outdated system that includes, at 39 percent for combined federal and state taxes, the highest statutory corporate rate among the developed countries. Worldwide, only the United Arab Emirates and Chad have higher rates. When companies leave the U.S., they take along jobs and investment, so inversions must end. But Treasury's proposed regulations won't achieve that goal because they offer no remedy for our broken code. Only this week, my home state of Ohio received confirmation of their ineffectiveness. Steris Corp., a health-care products company, based in Mentor, announced that it would merge with U.K.-based Synergy Health and move its corporate home to England. Analysts say the move will lower Steris's effective tax rate to 25 percent and save the company millions of dollars. Burger King and Medtronic also have decided to go through with their inversion deals despite Treasury's announced inversions. Worse yet, companies that the regulations would keep at home are becoming foreign takeover targets. One of those, Pennsylvania drugmaker Auxilium Pharmaceuticals, has agreed to be acquired by Endo, which itself Steris Corp. its headquarters to Ireland from Pennsylvania last year. Casting blame or questioning the patriotism of these companies will achieve nothing. Instead, we should use this opportunity to make the U.S. the best place to do business again. The defects in the tax code that make inversion Steris are the same as those that make those companies attractive as foreign takeover targets. They are well-documented and fixable: Not only does the U.S. have the highest corporate tax rate in the developed world, but in contrast to most of its foreign competitors, which use a so-called territorial system, this rate is imposed not only on income companies make at home, but also on income earned around the world. Making matters worse, the U.S. only taxes foreign sales when companies repatriate earnings, providing a strong disincentive for companies to bring money home. As a result, $2 trillion that could be reinvested in the U.S. economy sits in foreign bank accounts or is spent in other countries, creating jobs overseas that should be here. The good news is that, unlike many problems in Washington, there is bipartisan consensus on a solution: Tax reform. There's also general agreement on how it should be done. We must rid the code of ineffective deductions and loopholes that go only to favored interest groups. The money raised by eliminating those loopholes should be used to get our corporate rate down to at least the global average of 25 percent. We also have to move to a competitive territorial system of international taxation that taxes only income made in the U.S. There's an example of a country that has successfully applied this approach. In 2010, after the U.K. had endured its own spate of inversions, the government lowered the corporate rate to 21 percent from 28 percent, adopted a territorial system and declared the country "open for business." These reforms stopped inversions, and some companies that had left even came home. It shouldn't be surprising that that many U.S. companies now are ending up in the U.K. Given this broad agreement among U.S. policy makers that changing our tax code is urgent and necessary, it was disappointing to hear the Treasury secretary attempt to redefine a central ingredient of any change -- revenue-neutral tax reform -- saying that the traditional, 10-year budget window shouldn't apply. This has important consequences for businesses and workers. Put simply, the administration believes revenue-neutral tax reform outside of the 10-year budget window will require billions in tax increases in the first 10 years after reform legislation is enacted. Instead of sticking to a bipartisan approach, Secretary Lew suggested a return to the policies of using tax reform as a piggy bank to pay for new spending. But even more distressing, the secretary and President Barack Obama must know that such a proposal would be dead on arrival, no matter which party controls Congress. If we allow politics to stop us from fixing our broken code, the American worker will suffer. A 2007 Congressional Budget Office study showed that as much as 70 percent of the burden of corporate taxation is passed on to labor in the form of lower wages and benefits. Our labor force is struggling already: Unemployment is still high, and for every net job created under President Obama, almost three people have dropped out of the labor force completely, leaving us with the lowest labor participation rate since the Carter administration. Tax reform can only happen as a bipartisan effort, not a partisan squabble about tax cuts versus tax increases. We have accomplished that kind of bipartisanship in the past. Leading up to the last large-scale tax reform in 1986, President Ronald Reagan directed the Treasury to provide recommendations for a comprehensive overhaul. President Reagan then submitted 489 pages of specific policy proposals to a Democratic House and a Republican Senate, which hammered out the new code. We need this kind of engagement from the executive branch again if we're going to get tax reform across the finish line. This column does not necessarily reflect the opinion of Bloomberg View's editorial board or Bloomberg LP, its owners and investors.
News Article | March 31, 2015
(http://www.researchandmarkets.com/research/vn485q/testosterone) has announced the addition of the "Testosterone Replacement Therapy (TRT) - Global Strategic Business Report" report to their offering. This report analyzes the worldwide markets for Testosterone Replacement Therapy (TRT) in US$ Million. The Global and the US markets are analyzed by the following Product Segments: Topicals, Patches, and Others. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World. Annual estimates and forecasts are provided for the period 2013 through 2020. Also, a seven-year historic analysis is provided for these markets. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based on public domain information including company URLs. The report profiles 35 companies including many key and niche players such as: Key Topics Covered: 1. INDUSTRY OVERVIEW 2. GROWTH DRIVERS AND MARKET TRENDS 3. COMPETITION 4. AN OVERVIEW OF SELECT DRUGS ON THE MARKET 5. TESTOSTERONE DEFICIENCY AND TRT - AN OVERVIEW 6. PRODUCT LAUNCHES/APPROVALS 7. RECENT INDUSTRY ACTIVITY 8. FOCUS ON SELECT PLAYERS 9. GLOBAL MARKET PERSPECTIVE
News Article | November 8, 2016
"During the third quarter 2016, Endo further sharpened its focus on operational execution. We have continued to deliver results across all of our businesses that are on-track or ahead of Company expectations for the quarter. Today we are reaffirming our full year 2016 revenue and adjusted diluted EPS financial guidance," said Paul Campanelli, President and CEO of Endo. "This is an important time for Endo. The leadership team is working closely and collaboratively to build on our strengths and develop a go-forward strategy that best positions the Company to improve the lives of the patients and customers we serve." Total revenues increased by 19 percent to $884 million in third quarter 2016 compared to the same period in 2015, primarily attributable to revenues related to the September 2015 Par acquisition. GAAP net loss from continuing operations in third quarter 2016 decreased to $191 million compared to a GAAP net loss from continuing operations of $804 million during the same period in 2015, primarily attributable to the amount of goodwill and intangible asset impairment charges recorded during the third quarter 2015. GAAP net loss per share from continuing operations for the three months ended September 30, 2016 was $0.86, compared to a GAAP net loss from continuing operations of $3.84 in third quarter 2015. Adjusted net income from continuing operations for third quarter 2016 increased by 5 percent to $226 million compared to third quarter 2015, driven primarily by the contribution of Par, offset partially by an increase in interest expense. Adjusted net income per share from continuing operations for the three months ended September 30, 2016 decreased 1 percent to $1.01 compared to third quarter 2015. During third quarter 2016, the U.S. Branded Pharmaceuticals business unit continued to focus on supporting demand growth for XIAFLEX® in both the Dupuytren's contracture and Peyronie's disease indications and the BELBUCA™ launch continues to progress. During third quarter 2016, the U.S. Generic Pharmaceuticals business unit continued to execute on its sales and marketing, research and development (R&D), and manufacturing plans for the year. Third quarter and recent 2016 U.S. Generic Pharmaceuticals results include: During third quarter 2016, the International Pharmaceuticals business unit continued to focus on expanding adjusted margins for its emerging markets businesses, while in-licensing new products and managing the expected loss of exclusivity for certain products at Paladin. For the full twelve months ended December 31, 2016, at current exchange rates, Endo is reaffirming its full year revenue and adjusted diluted EPS financial guidance. The Company estimates: The Company's 2016 financial guidance is based on the following assumptions: As of September 30, 2016, the Company had $561.6 million in unrestricted cash; net debt of approximately $7.7 billion and a net debt to adjusted EBITDA ratio of 4.9. Third quarter 2016 cash used in operating activities was $111.3 million, primarily attributable to the funding of mesh payments, offset partially by improved cash collections. During third quarter 2016, the Company recorded impairment charges of $93.5 million primarily related to unfavorable formulary changes and market conditions impacting its Sumavel® DosePro® product. Endo will conduct a conference call with financial analysts to discuss this press release today at 8:30 a.m. ET. The dial-in number to access the call is U.S./Canada (866) 497-0462, International (678) 509-7598, and the passcode is 1074797. Please dial in 10 minutes prior to the scheduled start time. A replay of the call will be available from November 8, 2016 at 11:30 a.m. ET until 11:30 a.m. ET on November 22, 2016 by dialing U.S./Canada (855) 859-2056, International (404) 537-3406, and entering the passcode 1074797. A simultaneous webcast of the call can be accessed by visiting . In addition, a replay of the webcast will be available until 11:30 a.m. ET on November 22, 2016. The replay can be accessed by clicking on "Upcoming Events" in the Investor Relations section of the Endo website. The following table presents Endo's unaudited Net Revenues for the three and nine months ended September 30, 2016 and 2015: The following table presents unaudited consolidated Statement of Operations data for the three and nine months ended September 30, 2016 and 2015 (in thousands, except per share data): The following table presents unaudited condensed consolidated Balance Sheet data at September 30, 2016 and December 31, 2015 (in thousands): The following table presents unaudited condensed consolidated Statement of Cash Flow data for the nine months ended September 30, 2016 and 2015 (in thousands): The following schedule presents the significant pre-tax cash outlays and cash receipts impacting our Net cash provided by (used in) operating activities for the nine months ended September 30, 2016 and 2015 (in thousands): To supplement the financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP), the Company uses certain non-GAAP financial measures. For additional information on the Company's use of such non-GAAP financial measures, refer to Endo's Current Report on Form 8-K furnished today to the Securities and Exchange Commission, which includes an explanation of the Company's reasons for using non-GAAP measures. The table below provides reconciliations of our consolidated income (loss) from continuing operations (GAAP) to our adjusted income from continuing operations (non-GAAP) for the three and nine months ended September 30, 2016 and 2015: Notes to the reconciliation of certain line items included in the GAAP Statements of Operations to the Non-GAAP line items are as follows: (1) Adjustments for amortization of commercial intangible assets included the following: (2) Adjustments for inventory step-up and other cost savings included the following: (3) Adjustments for upfront and milestone-related payments to partners included the following: (4) To exclude decreases of excess inventory reserves of $(9.0) million recorded during the three months ended September 30, 2016, primarily related to the 2016 U.S. Generic Pharmaceuticals restructuring initiative. This adjustment resulted from the sell-through of certain inventory previously reserved. (5) Adjustments for separation benefits and other restructuring included the following: (7) To exclude asset impairment charges. During the three months ended September 30, 2016 and 2015, we recorded impairment charges of $93.5 million resulting from a charge of $72.8 million in our U.S. Branded Pharmaceuticals segment relating to our Sumavel® DosePro® product, which resulted from unfavorable formulary changes and a downturn in its performance, and a $16.2 million charge on a definite-lived intangible asset in our International Pharmaceuticals segment relating to a third quarter 2016 decision not to pursue commercialization of a product in certain international markets. During the three months ended September 30, 2015, we recorded impairment charges of $923.6 million resulting from a charge of $680.0 million, representing the difference between the estimated implied fair value of the former UEO reporting unit's goodwill and its respective net book value, and charges of approximately $242.9 million on certain intangible assets primarily from our U.S. Branded Pharmaceuticals and U.S. Generic Pharmaceuticals segments. (8) Adjustments for acquisition and integration items primarily relate to various acquisitions, including Par Pharmaceuticals and Auxilium Pharmaceuticals, and included the following: (9) To exclude the impact of the change in fair value of contingent consideration resulting from certain market conditions impacting the commercial potential of the underlying products. (11) Adjustments to other included the following: (12) Adjusted income taxes are calculated by tax effecting adjusted pre-tax income at the applicable effective tax rate that will be determined by reference to statutory tax rates in the relevant jurisdiction in which the Company operates and includes current and deferred income tax expense commensurate with the non-GAAP measure of profitability. During the third quarter of 2016, Endo completed a legal entity reorganization of the Generics business. The restructuring resulted in the recording of a deferred tax charge of $395.1 million in accordance with applicable accounting guidance. Within the third quarter, Endo recorded a net discrete tax expense of $42.6 million primarily related to the amortization of the aforementioned deferred charge, which was partially offset by a favorable return to provision adjustment resulting from filing U.S. federal income tax returns. In accordance with our adjusted policy, all but a tax benefit of $4.4 million of the net discrete tax expense has been removed from our adjusted tax expense due to the distortive nature of the deferred charge amortization. The remaining tax benefit of $4.4 million is associated with the filing of the U.S. federal income tax returns. Refer to footnote 14 in the Reconciliation of GAAP and Non-GAAP Financial Measures tables for nine months ended September 30, 2016 and 2015 for further discussion of the legal entity reorganization discussed above and our change in policy resulting from the SEC's updated guidance on Non-GAAP measures issued in May 2016. (13) To exclude the results of the Astora business reported as discontinued operations, net of tax. (14) This amount includes non-controlling interest $(46) for the three months ended September 30, 2015. (15) Calculated as income (loss) from continuing operations divided by the applicable weighted average share number. The applicable weighted average share number for the three months ended September 30, 2016 is 222,767 and 223,139 for the GAAP and non-GAAP EPS calculations, respectively. The applicable weighted average share number for the three months ended September 30, 2015 is 209,274 for the GAAP EPS calculation and 210,787 for the non-GAAP EPS calculations, respectively. Notes to the reconciliation of certain line items included in the GAAP Statements of Operations to the Non-GAAP line items are as follows: (1) Adjustments for amortization of commercial intangible assets included the following: (2) Adjustments for inventory step-up and other cost savings included the following: (3) Adjustments for upfront and milestone-related payments to partners included the following: (4) To exclude charges due to increases of excess inventory reserves related to the 2016 U.S. Generic Pharmaceuticals restructuring initiative. (5) To adjust for the reversal of the remaining Voltaren® Gel minimum royalty obligations as a result of a generic entrant. (6) Adjustments for separation benefits and other restructuring included the following: (7) To exclude the acceleration of Auxilium employee equity awards at closing of acquisition. (9) To exclude asset impairment charges. During the nine months ended September 30, 2016 we recorded pre-tax, non-cash impairment charges of $263.1 million as a result of a charge of $72.8 million in our U.S. Branded Pharmaceuticals segment relating to our Sumavel® DosePro® product, which resulted from unfavorable formulary changes and a downturn in its performance, a $16.2 million charge on a definite-lived intangible asset in our International Pharmaceuticals segment relating to a third quarter 2016 decision not to pursue commercialization of a product in certain international markets, a $69.0 million charge due to certain market conditions impacting the commercial potential of certain intangible assets in our U.S. Generic Pharmaceuticals segment, a $100.3 million charge related to the 2016 U.S. Generic Pharmaceuticals restructuring initiative, which resulted from the discontinuation of certain commercial products and the abandonment of certain IPR&D projects. During the nine months ended September 20, 2015, we recorded pre-tax, non-cash impairment charges of $1.0 billion as a result of a third quarter 2015 provisional impairment charge of $680.0 million, representing the difference between the estimated implied fair value of the former UEO reporting unit's goodwill and its respective net book value, $313.1 million on certain intangible assets primarily from our U.S. Branded Pharmaceuticals and U.S. Generic Pharmaceuticals segments, and $7.0 million on certain leasehold improvements associated with Auxilium's former headquarters. (10) Adjustments for acquisition and integration items primarily relate to various acquisitions, including Par Pharmaceuticals and Auxilium Pharmaceuticals, and included the following: (11) To exclude the impact of the change in fair value of contingent consideration resulting from certain market conditions impacting the commercial potential of the underlying products. (12) Adjustments to interest charges included the following: (13) Adjustments to other included the following: (14) During the third quarter of 2016, Endo completed a legal entity reorganization that moved the Generics business to a new U.S. holding company structure that is separate from the legacy Branded business structure. The reorganization also provides operating flexibility and benefits and reduces the potential impact related to any future limits that could apply to the use of tax attributes by utilizing most of the Company's attributes to offset the gain in the intercompany sale that stepped-up the tax basis of the U.S. Generics business assets. The utilization of acquired attributes in the reorganization would have had an unfavorable impact of $157 million on our full-year 2016 adjusted tax expense under Endo's non-GAAP policy prior to the adoption of the SEC's updated guidance on Non-GAAP measures (see below). The elimination of this acquired attribute benefit was largely offset by an improved mix of jurisdictional adjusted pre-tax income resulting primarily from the reorganization. The reorganization also gave rise to a discrete GAAP tax benefit of $635 million arising from outside basis differences. This benefit has been excluded from our adjusted effective tax rate in accordance with our policy. Separately, as a result of the SEC's updated guidance on Non-GAAP measures issued in May 2016, Endo is no longer excluding the non-cash deferred tax expense associated with acquired attributes in our adjusted income tax expense. This change has no impact on Endo's historic or forward looking GAAP tax or cash tax profile. Additionally, as we have utilized substantially all of our acquired attributes through the recent legal entity reorganization, our change in policy is not expected to have a material impact on our 2016 and forward looking adjusted tax rate. The following table presents the impact of our change in policy on Adjusted Diluted EPS from Continuing Operations for each relevant period of 2015 and 2016: *Amounts in the table above may not add due to rounding (15) To exclude the results of the Astora business reported as discontinued operations, net of tax. (16) This amount includes noncontrolling interests of $16 and $(153) for the nine months ended September 30, 2016 and 2015, respectively. (17) Calculated as income (loss) from continuing operations divided by the applicable weighted average share number. The applicable weighted average share number for the nine months ended September 30, 2016 is 223,060 for both the GAAP and non-GAAP EPS calculations. The applicable weighted average share number for the nine months ended September 30, 2015 is 188,085 and 192,144 for the GAAP and non-GAAP EPS calculations, respectively. The Company's guidance is being issued based on certain assumptions including: The Company utilizes certain financial measures that are not prescribed by or prepared in accordance with accounting principles generally accepted in the U.S. (GAAP). These Non-GAAP financial measures are not, and should not be viewed as, substitutes for U.S. GAAP net income and its components and diluted earnings per share amounts. Despite the importance of these measures to management in goal setting and performance measurement, we stress that these are Non-GAAP financial measures that have no standardized meaning prescribed by U.S. GAAP and, therefore, have limits in their usefulness to investors. Because of the non-standardized definitions, Non-GAAP adjusted EBITDA and Non-GAAP adjusted net income and its components (unlike U.S. GAAP net income and its components) may not be comparable to the calculation of similar measures of other companies. These Non-GAAP financial measures are presented solely to permit investors to more fully understand how management assesses performance. See Endo's Current Report on Form 8-K furnished today to the Securities and Exchange Commission for an explanation of Endo's non-GAAP financial measures. Endo International plc (NASDAQ: ENDP) (TSX: ENL) is a global specialty pharmaceutical company focused on improving patients' lives while creating shareholder value. Endo develops, manufactures, markets and distributes quality branded and generic pharmaceutical products as well as over-the-counter medications though its operating companies. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA. Learn more at www.endo.com. This press release contains forward-looking statements, including but not limited to the statements by Mr. Campanelli and other statements regarding product development, market potential, corporate strategy, optimization efforts and restructurings, expected growth and regulatory approvals, as well as Endo's earnings per share amounts, product net sales, revenue forecasts and any other statements that refer to Endo's expected, estimated or anticipated future results. Because forecasts are inherently estimates that cannot be made with precision, Endo's performance at times differs materially from its estimates and targets, and Endo often does not know what the actual results will be until after the end of the applicable reporting period. Therefore, Endo will not report or comment on its progress during a current quarter except through public announcement. Any statement made by others with respect to progress during a current quarter cannot be attributed to Endo. All forward-looking statements in this press release reflect Endo's current analysis of existing trends and information and represent Endo's judgment only as of the date of this press release. Actual results may differ materially from current expectations based on a number of factors affecting Endo's businesses, including, among other things, the following: changing competitive, market and regulatory conditions; Endo's ability to obtain and maintain adequate protection for its intellectual property rights; the timing and uncertainty of the results of both the research and development and regulatory processes; domestic and foreign health care and cost containment reforms, including government pricing, tax and reimbursement policies; technological advances and patents obtained by competitors; the performance, including the approval, introduction, and consumer and physician acceptance of new products and the continuing acceptance of currently marketed products; the effectiveness of advertising and other promotional campaigns; the timely and successful implementation of strategic initiatives; the results of any pending or future litigation, investigations or claims; the uncertainty associated with the identification of and successful consummation and execution of external corporate development initiatives and strategic partnering transactions; and Endo's ability to obtain and successfully maintain a sufficient supply of products to meet market demand in a timely manner. In addition, U.S. and international economic conditions, including higher unemployment, political instability, financial hardship, consumer confidence and debt levels, taxation, changes in interest and currency exchange rates, international relations, capital and credit availability, the status of financial markets and institutions, fluctuations or devaluations in the value of sovereign government debt, as well as the general impact of continued economic volatility, can materially affect Endo's results. Therefore, the reader is cautioned not to rely on these forward-looking statements. Endo expressly disclaims any intent or obligation to update these forward-looking statements except as required to do so by law. Additional information concerning the above-referenced risk factors and other risk factors can be found in press releases issued by Endo, as well as Endo's public periodic filings with the U.S. Securities and Exchange Commission and with securities regulators in Canada, including the discussion under the heading "Risk Factors" in Endo's 2015 Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q. Copies of Endo's press releases and additional information about Endo are available at www.endo.com or you can contact the Endo Investor Relations Department by calling 484-216-0000.