AMRX Amneal Pharmaceuticals Inc. Class A

4.25
-0.02  -0%
Previous Close 4.27
Open 4.25
52 Week Low 2.27
52 Week High 5.79
Market Cap $1,273,539,007
Shares 299,656,237
Float 297,231,774
Enterprise Value $3,987,716,131
Volume 779,358
Av. Daily Volume 1,408,782
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Drug Pipeline

Drug Stage Notes
IPX203
Parkinson's disease
Phase 3
Phase 3
Phase 3 trial ongoing.
K127
Myasthenia Gravis
NDA Filing
NDA Filing
NDA filing planned.

Latest News

  1. WARSAW, Ind., Aug. 12, 2020 (GLOBE NEWSWIRE) -- WishBone Medical, Inc., a leader in pediatric orthopedic medical devices, is pleased to announce the appointment of Jeff George, global healthcare executive and investor, to the company's board of directors, effective August 12, 2020.

    "As WishBone takes on more opportunities and acquisitions, it is important to add expertise and capital, of which Jeff George provides both," said Nick Deeter, founder, Chairman, and CEO of WishBone Medical. "Emerging growth companies like ours go through numerous phases in their development. Jeff is an extremely important addition to the Board – he will help WishBone to implement the plan and become the undisputed leader in pediatric orthopedics. WishBone has…

    WARSAW, Ind., Aug. 12, 2020 (GLOBE NEWSWIRE) -- WishBone Medical, Inc., a leader in pediatric orthopedic medical devices, is pleased to announce the appointment of Jeff George, global healthcare executive and investor, to the company's board of directors, effective August 12, 2020.

    "As WishBone takes on more opportunities and acquisitions, it is important to add expertise and capital, of which Jeff George provides both," said Nick Deeter, founder, Chairman, and CEO of WishBone Medical. "Emerging growth companies like ours go through numerous phases in their development. Jeff is an extremely important addition to the Board – he will help WishBone to implement the plan and become the undisputed leader in pediatric orthopedics. WishBone has moved at light speed to raise standards for the 95%* of children who still receive adult implants that are not FDA-cleared for pediatric use. As the first and only pediatric orthopedic company operating with a 'single-use' business model, we're on track to fully mitigate this issue once and for all."

    Jeff is currently Managing Partner of Maytal Capital, a healthcare-focused private equity and venture capital investment and advisory firm he founded in 2017, and an Operating Partner at Revival Healthcare Capital, a medical device-focused private equity firm based in Texas.  He serves on the Board of Directors at Amneal Pharmaeuticals (NYSE:AMRX), a leading specialty and generic pharmaceuticals company, and at Roam Analytics, a Silicon Valley-based artificial intelligence healthcare software firm. From 2008 to 2016, Jeff served on the Executive Committee of Switzerland-based Novartis Group AG, one of the world's largest pharmaceutical companies, where he served as Division Head & CEO of Sandoz, Novartis's $10 billion generic pharmaceuticals and biosimilars subsidiary headquartered in Munich, Germany and then as Division Head & CEO of Texas-based Alcon, Novartis's then $10 billion eyecare subsidiary.  

    "WishBone is an exciting, mission-driven, and rapidly-growing leader in pediatric orthopedics, and I am honored to join the Board," said Jeff George. "Spending time with Nick and his leadership team the past year has given me strong conviction that WishBone is poised for continued break-out growth as we work to meet the significant unmet need for kids in this important field. I look forward to partnering with Nick and the Board to support WishBone as it scales in the US and globally."

    Jeff holds an MBA from Harvard Business School and a master's degree from Johns Hopkins University's School of Advanced International Studies (SAIS), where he studied international economics and emerging markets political economy.  He received his B.A. in international relations, magna cum laude and Phi Beta Kappa, from Carleton College.  An active volunteer, Jeff also serves on the board of directors for several non-profit organizations, including Education Opens Doors (where he is Chairman), the North Texas Food Bank, and the Young Presidents' Organization (YPO) of Dallas.  He previously served on the Board of Directors for AdvaMed, the medical device industry association.  Both he and Maytal Capital are based in Dallas, Texas.

    *Data on file.

    About WishBone Medical

    WishBone Medical is a global pediatric orthopedic company, committed to providing anatomically appropriate innovative implants, instruments and biologics in single-use, sterile packed procedure kits, designed to prevent infection, reduce overall costs for customers and achieve the best outcomes for children around the world who are still growing. The WishBone Medical Family of Companies offers 42 product systems with operations in Warsaw, IN, Istanbul, and Singapore.

    For further information, visit WishBoneMedical.com or contact Kaitlyn Hughes, Director of Marketing & Communications, at +1-574-306-4006.

    Contact:

    Kaitlyn Hughes

    +1-574-306-4006



    WishBoneMedical.com

    Primary Logo

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  2.  ‒ Q2 2020 Net Revenue of $465 million; GAAP Net Loss of $(12) million; Diluted Loss per Share of $(0.08) ‒

    ‒ Q2 2020 Adjusted Net Income (1) of $38 million; Adjusted EBITDA (1) of $101 million; Adjusted Diluted EPS (1) of $0.13‒

    ‒ Maintaining 2020 Full Year Financial Outlook ‒

    Amneal Pharmaceuticals, Inc. (NYSE:AMRX) (the "Company") announced its results today for the second quarter ended June 30, 2020.

    "Amneal executed well against our operational and strategic goals in the second quarter and, even in the face of COVID-related headwinds, delivered strong financial results," said Chirag and Chintu Patel, Co-Chief Executive Officers. "Our commitment to execution, innovation and cost efficiency continues to drive growth across our Generics…

     ‒ Q2 2020 Net Revenue of $465 million; GAAP Net Loss of $(12) million; Diluted Loss per Share of $(0.08) ‒

    ‒ Q2 2020 Adjusted Net Income (1) of $38 million; Adjusted EBITDA (1) of $101 million; Adjusted Diluted EPS (1) of $0.13‒

    ‒ Maintaining 2020 Full Year Financial Outlook ‒

    Amneal Pharmaceuticals, Inc. (NYSE:AMRX) (the "Company") announced its results today for the second quarter ended June 30, 2020.

    "Amneal executed well against our operational and strategic goals in the second quarter and, even in the face of COVID-related headwinds, delivered strong financial results," said Chirag and Chintu Patel, Co-Chief Executive Officers. "Our commitment to execution, innovation and cost efficiency continues to drive growth across our Generics, Specialty and AvKARE segments and positions us well for the remainder of 2020 and beyond. We are extremely proud of our employees across the globe, who have demonstrated resiliency during this public health crisis and remain dedicated to our mission of bringing affordable medicines to patients."

    Net revenue in the second quarter of 2020 was $465 million, an increase of 15% compared to $405 million in the second quarter of 2019, primarily due to the acquisition of 65% of AvKARE and its related entities, hereinafter referred to as "AvKARE" and growth of our Specialty segment. Net loss attributable to Amneal Pharmaceuticals, Inc. of $12 million in the second quarter compared to a net loss of $17 million in prior year period, reflects higher gross profit and lower interest expense, partially offset by higher operating expenses related to AvKARE. Diluted loss per share in the second quarter was $0.08 compared to a loss of $0.13 in the prior year period.

    Adjusted EBITDA(1) in the second quarter of 2020 was $101 million, an increase of 9% compared to the prior year period, primarily due to higher gross profit partially offset by higher operating expenses. Adjusted net income(1) in the second quarter was $38 million, an increase of 42% compared to the prior year period, and primarily reflects higher adjusted EBITDA(1) and lower interest expense, partially offset by higher non-controlling interests due to the acquisition of 65% of AvKARE. Adjusted diluted EPS(1) in the second quarter was $0.13, compared to $0.09 for the prior year period.

    (1)

    See "Non-GAAP Financial Measures" below.

    Maintaining Full Year 2020 Financial Outlook

    Amneal is maintaining its previously provided 2020 guidance; operating cash flow excludes an expected $110 million cash tax refund, of which approximately $106 million was received during July 2020.

     

    Full Year 2020 Financial Guidance

    Net revenue

    $1,875 million - $1,975 million

    Adjusted gross margin

    44% - 46%

    Adjusted EBITDA (1)

    $400 million - $450 million

    Adjusted diluted EPS (2)

    $0.45 - $0.60

    Operating cash flow

    $150 million - $200 million

    Capital expenditures

    $60 million - $70 million

    Weighted average diluted shares outstanding (3)

    Approximately 300 million

    (1)

    Includes 100% of EBITDA from the AvKARE acquisition.

    (2)

    Accounts for 35% non-controlling interest in AvKARE.

    (3)

    Assumes the weighted average diluted shares outstanding of Class A and Class B shares under the if-converted method.

    Conference Call Information

    Amneal will host a conference call and live webcast at 8:30 am Eastern Time on August 6, 2020 to discuss its results. The live webcast and presentation will be accessible through the Investor Relations section of the Company's website at https://investors.amneal.com. To access the call through a conference line, dial (844) 746-0741 (in the U.S.) or (412) 317-5273 (international callers). A replay of the conference call will be posted shortly after the call and will be available for seven days. To access the replay, dial (877) 344-7529 (in the U.S.) or (412) 317-0088 (international callers). The access code for the replay is 10145923.

    About Amneal

    Amneal Pharmaceuticals, Inc. (NYSE:AMRX), headquartered in Bridgewater, NJ, is a fully-integrated pharmaceutical company focused on the development, manufacturing and distribution of generic and specialty drug products. The Company has operations in North America, Asia, and Europe, working together to bring high-quality medicines to patients primarily within the United States.

    Amneal has an extensive portfolio of approximately 250 product families and is expanding its portfolio to include complex dosage forms, including biosimilars, in a broad range of therapeutic areas. The Company also markets a portfolio of branded pharmaceutical products through its Specialty segment focused principally on central nervous system and endocrine disorders.

    The Company also owns 65% of AvKARE. AvKARE provides pharmaceuticals, medical and surgical products and services primarily to governmental agencies, primarily focused on serving the Department of Defense and the Department of Veterans Affairs. AvKARE is also a packager and wholesale distributor of pharmaceuticals and vitamins to its retail and institutional customers who are located throughout the United States focused primarily on offering 340b-qualified entities products to provide consistency in care and pricing. For more information, visit www.amneal.com.

    Cautionary Statement on Forward-Looking Statements

    Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management's intentions, plans, beliefs, expectations or forecasts for the future, including, among other things, future operating results and financial performance, product development and launches, integration strategies and resulting cost reduction, market position and business strategy. Words such as "may," "will," "could," "expect," "plan," "anticipate," "intend," "believe," "estimate," "assume," "continue," and similar words are intended to identify estimates and forward-looking statements.

    The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company. Such risks and uncertainties include, but are not limited to: the potential impact of the COVID-19 pandemic on our business, manufacturing, supply chain, financial results, financial condition, and planned capital expenditures and national and international economies, the risk that our goodwill may become impaired, which could adversely affect our financial condition and results of operations, the impact of global economic conditions; our ability to successfully develop, license, acquire and commercialize new products on a timely basis; our ability to obtain exclusive marketing rights for our products; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to manage our growth through acquisitions and otherwise; our dependence on the sales of a limited number of products for a substantial portion of our total revenues; the risk of product liability and other claims against us by consumers and other third parties; risks related to changes in the regulatory environment, including United States federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to FDA product approval requirements; risks related to federal regulation of arrangements between manufacturers of branded and generic products; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; the continuing trend of consolidation of certain customer groups; our reliance on certain licenses to proprietary technologies from time to time; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; our dependence on third-party agreements for a portion of our product offerings; our ability to identify and make acquisitions of or investments in complementary businesses and products on advantageous terms; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; the significant amount of resources we expend on research and development; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; and the high concentration of ownership of our Class A Common Stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company's filings with the Securities and Exchange Commission, including under Item 1A, "Risk Factors" in the Company's most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

    Non-GAAP Financial Measures

    This release includes certain non-GAAP financial measures, including adjusted EBITDA, adjusted net income, adjusted net income per diluted share, adjusted gross profit, adjusted gross margin and adjusted operating income, which are intended as supplemental measures of the Company's performance that are not required by or presented in accordance with U.S. General Accepted Accounting Principles ("GAAP"). All business results presented in this release are not prepared in accordance with Article 11 of Regulation S-X. The calculation of non-GAAP adjusted diluted earnings per share assumes the conversion of all outstanding shares of Class B Common Stock to shares of Class A Common Stock.

    Management uses these non-GAAP measures internally to evaluate and manage the Company's operations and to better understand its business because they facilitate a comparative assessment of the Company's operating performance relative to its performance based on results calculated under GAAP. These non-GAAP measures also isolate the effects of some items that vary from period to period without any correlation to core operating performance and eliminate certain charges that management believes do not reflect the Company's operations and underlying operational performance. The compensation committee of the Company's board of directors also uses certain of these measures to evaluate management's performance and set its compensation. The Company believes that these non-GAAP measures also provide useful information to investors regarding certain financial and business trends relating to the Company's financial condition and operating results facilitates an evaluation of the financial performance of the Company and its operations on a consistent basis. Providing this information therefore allows investors to make independent assessments of the Company's financial performance, results of operation and trends while viewing the information through the eyes of management.

    These non-GAAP measures are subject to limitations. The non-GAAP measures presented in this release may not be comparable to similarly titled measures used by other companies because other companies may not calculate one or more in the same manner. Additionally, the non-GAAP performance measures exclude significant expenses and income that are required by GAAP to be recorded in the Company's financial statements; do not reflect changes in, or cash requirements for, working capital needs; and do not reflect interest expense, or the requirements necessary to service interest or principal payments on debt. Further, our historical adjusted results are not intended to project our adjusted results of operations or financial position for any future period. To compensate for these limitations, management presents and considers these non-GAAP measures in conjunction with the Company's GAAP results; no non-GAAP measure should be considered in isolation from or as alternatives to net income, diluted earnings per share or any other measure determined in accordance with GAAP. Readers should review the reconciliations included below, and should not rely on any single financial measure to evaluate the Company's business.

    The Company cannot provide a reconciliation between non-GAAP projections and the most directly comparable GAAP measures without unreasonable efforts because it is unable to predict with reasonable certainty the ultimate outcome of certain significant items required for the reconciliation. The items include, but are not limited to, acquisition-related expenses, restructuring expenses and benefits, asset impairments and other gains and losses. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results.

    A reconciliation of each non-GAAP measure to the most directly comparable GAAP measure is set forth below.

    Amneal Pharmaceuticals, Inc.

    Consolidated Statements of Operations

    (Unaudited; In thousands, except per share amounts)

     

     

    Three Months Ended

    June 30,

     

    Six Months Ended

    June 30,

     

    2020

     

    2019

     

    2020

     

    2019

    Net revenue

    $

    464,662

     

     

    $

    404,642

     

     

    $

    963,195

     

     

    $

    850,762

     

    Cost of goods sold

    319,666

     

     

    296,381

     

     

    633,244

     

     

    606,124

     

    Cost of goods sold impairment charges

    759

     

     

    3,012

     

     

    2,215

     

     

    56,309

     

    Gross profit

    144,237

     

     

    105,249

     

     

    327,736

     

     

    188,329

     

    Selling, general and administrative

    80,944

     

     

    67,281

     

     

    158,920

     

     

    151,717

     

    Research and development

    45,572

     

     

    48,016

     

     

    81,951

     

     

    101,874

     

    In-process research and development impairment charges

     

     

     

     

    960

     

     

    22,787

     

    Intellectual property legal development expenses

    3,550

     

     

    2,511

     

     

    4,820

     

     

    6,677

     

    Acquisition, transaction-related and integration expenses

    1,787

     

     

    3,519

     

     

    4,362

     

     

    9,551

     

    Charges related to legal matters, net

    1,300

     

     

     

     

    5,800

     

     

     

    Restructuring and other charges

    333

     

     

    2,835

     

     

    2,381

     

     

    8,996

     

    Operating income (loss)

    10,751

     

     

    (18,913)

     

     

    68,542

     

     

    (113,273)

     

    Other (expense) income:

     

     

     

     

     

     

     

    Interest expense, net

    (36,669)

     

     

    (43,886)

     

     

    (76,568)

     

     

    (87,167)

     

    Foreign exchange gain (loss), net

    3,466

     

     

    8,311

     

     

    (1,715)

     

     

    2,847

     

    Gain (loss) on sale of international businesses, net

    123

     

     

    (1,888)

     

     

    123

     

     

    6,930

     

    Other income, net

    571

     

     

    149

     

     

    1,204

     

     

    1,256

     

    Total other expense, net

    (32,509)

     

     

    (37,314)

     

     

    (76,956)

     

     

    (76,134)

     

    Loss before income taxes

    (21,758)

     

     

    (56,227)

     

     

    (8,414)

     

     

    (189,407)

     

    Provision for (benefit from) income taxes

    2,186

     

     

    (5,701)

     

     

    (105,987)

     

     

    (14,129)

     

    Net (loss) income

    (23,944)

     

     

    (50,526)

     

     

    97,573

     

     

    (175,278)

     

    Less: Net loss attributable to non-controlling interests

    11,948

     

     

    33,624

     

     

    5,498

     

     

    110,495

     

    Net (loss) income attributable to Amneal Pharmaceuticals, Inc.

    (11,996)

     

     

    (16,902)

     

     

    103,071

     

     

    (64,783)

     

    Net (loss) income per share attributable to Amneal

    Pharmaceuticals, Inc.'s common stockholders:

     

     

     

     

     

     

     

    Class A and Class B-1 basic

    $

    (0.08)

     

     

    $

    (0.13)

     

     

    $

    0.70

     

     

    $

    (0.51)

     

    Class A and Class B-1 diluted

    $

    (0.08)

     

     

    $

    (0.13)

     

     

    $

    0.69

     

     

    $

    (0.51)

     

    Weighted-average common shares outstanding:

     

     

     

     

     

     

     

    Class A and Class B-1 basic

    147,392

     

     

    128,016

     

     

    147,286

     

     

    127,852

     

    Class A and Class B-1 diluted

    147,392

     

     

    128,016

     

     

    148,309

     

     

    127,852

     

    Amneal Pharmaceuticals, Inc.

    Condensed Consolidated Balance Sheets

    (Unaudited; In thousands)

     

     

    June 30, 2020

     

    December 31, 2019

    Assets

     

     

     

    Current assets:

     

     

     

    Cash and cash equivalents

    $

    266,143

     

     

    $

    151,197

     

    Restricted cash

    2,129

     

     

    1,625

     

    Trade accounts receivable, net

    582,734

     

     

    604,390

     

    Inventories

    443,956

     

     

    381,067

     

    Prepaid expenses and other current assets

    184,748

     

     

    70,164

     

    Related party receivables

    1,164

     

     

    1,767

     

    Total current assets

    1,480,874

     

     

    1,210,210

     

    Property, plant and equipment, net

    460,528

     

     

    477,997

     

    Goodwill

    527,475

     

     

    419,504

     

    Intangible assets, net

    1,423,826

     

     

    1,382,753

     

    Operating lease right-of-use assets

    49,159

     

     

    53,344

     

    Operating lease right-of-use assets - related party

    26,183

     

     

    16,528

     

    Financing lease right-of-use assets - related party

    59,980

     

     

    61,284

     

    Other assets

    28,731

     

     

    44,270

     

    Total assets

    $

    4,056,756

     

     

    $

    3,665,890

     

    Liabilities and Stockholders' Equity

     

     

     

    Current liabilities:

     

     

     

    Accounts payable and accrued expenses

    $

    599,489

     

     

    $

    507,483

     

    Current portion of long-term debt, net

    29,756

     

     

    21,479

     

    Current portion of operating lease liabilities

    12,512

     

     

    11,874

     

    Current portion of operating and financing lease liabilities - related party

    3,807

     

     

    3,601

     

    Current portion of note payable - related party

    1,000

     

     

     

    Related party payable - short term

    8,455

     

     

    5,969

     

    Total current liabilities

    655,019

     

     

    550,406

     

    Long-term debt, net

    2,764,578

     

     

    2,609,046

     

    Note payable - related party

    35,661

     

     

     

    Operating lease liabilities

    38,591

     

     

    43,135

     

    Operating lease liabilities - related party

    24,478

     

     

    15,469

     

    Financing lease liabilities - related party

    60,782

     

     

    61,463

     

    Related party payable - long term

    479

     

     

     

    Other long-term liabilities

    93,772

     

     

    39,583

     

    Total long-term liabilities

    3,018,341

     

     

    2,768,696

     

    Redeemable non-controlling interests

    12,380

     

     

     

    Total stockholders' equity

    371,016

     

     

    346,788

     

    Total liabilities and stockholders' equity

    $

    4,056,756

     

     

    $

    3,665,890

     

    Amneal Pharmaceuticals, Inc.

    Consolidated Statements of Cash Flows

    (Unaudited; In thousands)

     

     

    Six Months Ended June 30,

     

    2020

     

    2019

    Cash flows from operating activities:

     

     

     

    Net income (loss)

    $

    97,573

     

     

    $

    (175,278)

     

    Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:

     

     

     

    Depreciation and amortization

    116,155

     

     

    99,574

     

    Amortization of Levothyroxine Transition Agreement asset

     

     

    36,393

     

    Unrealized foreign currency loss (gain)

    1,251

     

     

    (3,695)

     

    Amortization of debt issuance costs and discount

    4,214

     

     

    3,218

     

    Gain on sale of international businesses, net

    (123)

     

     

    (6,930)

     

    Intangible asset impairment charges

    3,175

     

     

    79,096

     

    Non-cash restructuring and asset-related charges

     

     

    1,314

     

    Deferred tax benefit

     

     

    (18,209)

     

    Stock-based compensation

    10,202

     

     

    10,571

     

    Inventory provision

    34,708

     

     

    50,410

     

    Other operating charges and credits, net

    4,156

     

     

    3,155

     

    Changes in assets and liabilities:

     

     

     

    Trade accounts receivable, net

    75,769

     

     

    (162,954)

     

    Inventories

    (33,182)

     

     

    (19,658)

     

    Income taxes receivable associated with the CARES Act

    (110,069)

     

     

     

    Prepaid expenses, other current assets and other assets

    8,772

     

     

    28,614

     

    Related party receivables

    633

     

     

    (1,624)

     

    Accounts payable, accrued expenses and other liabilities

    15,172

     

     

    (13,538)

     

    Related party payables

    (139)

     

     

    2,225

     

    Net cash provided by (used in) operating activities

    228,267

     

     

    (87,316)

     

    Cash flows from investing activities:

     

     

     

    Purchases of property, plant and equipment

    (15,919)

     

     

    (29,629)

     

    Acquisition of intangible assets

    (1,050)

     

     

    (50,000)

     

    Acquisitions, net of cash acquired

    (254,000)

     

     

     

    Proceeds from sale of international businesses, net of cash sold

     

     

    34,834

     

    Net cash used in investing activities

    (270,969)

     

     

    (44,795)

     

    Cash flows from financing activities:

     

     

     

    Proceeds from issuance of debt

    180,000

     

     

     

    Payments of principal on debt, financing leases and other

    (17,072)

     

     

    (13,500)

     

    Payments of deferred financing costs

    (4,102)

     

     

     

    Proceeds from exercise of stock options

    158

     

     

    1,385

     

    Employee payroll tax withholding on restricted stock unit vesting

    (557)

     

     

    (921)

     

    Acquisition of non-controlling interest

     

     

    (3,543)

     

    Tax distribution to non-controlling interest

     

     

    (13,494)

     

    Payments of principal on financing lease - related party

    (530)

     

     

    (866)

     

    Net cash provided by (used in) financing activities

    157,897

     

     

    (30,939)

     

    Effect of foreign exchange rate on cash

    255

     

     

    1,293

     

    Net increase (decrease) in cash, cash equivalents, and restricted cash

    115,450

     

     

    (161,757)

     

    Cash, cash equivalents, and restricted cash - beginning of period

    152,822

     

     

    218,779

     

    Cash, cash equivalents, and restricted cash - end of period

    $

    268,272

     

     

    $

    57,022

     

    Cash and cash equivalents - end of period

    266,143

     

     

    54,893

     

    Restricted cash - end of period

    2,129

     

     

    2,129

     

    Cash, cash equivalents, and restricted cash - end of period

    $

    268,272

     

     

    $

    57,022

     

    Amneal Pharmaceuticals, Inc.

    Generics Operating Results

    (Unaudited; In thousands)

     

    Generics

    Three Months Ended

    June 30,

     

    Six Months Ended

    June 30,

     

    2020

     

    2019

     

    2020

     

    2019

    Net revenue – Generics

    $

    306,559

     

     

    $

    335,064

     

     

    $

    659,145

     

     

    $

    717,541

     

    Cost of goods sold

    218,909

     

     

    263,423

     

     

    437,774

     

     

    542,301

     

    Cost of goods sold impairment charges

    759

     

     

    3,012

     

     

    2,215

     

     

    56,309

     

    Gross profit

    86,891

     

     

    68,629

     

     

    219,156

     

     

    118,931

     

    Selling, general, and administrative

    12,802

     

     

    14,379

     

     

    29,425

     

     

    38,527

     

    Research and development

    40,316

     

     

    45,448

     

     

    69,350

     

     

    95,599

     

    Charges related to legal matters

    3,050

     

     

     

     

    5,550

     

     

     

    In-process research and development impairment charges

     

     

     

     

    960

     

     

    22,787

     

    Intellectual property legal development expenses

    3,550

     

     

    2,511

     

     

    4,815

     

     

    5,632

     

    Other operating expenses, net

    657

     

     

    1,405

     

     

    703

     

     

    6,083

     

    Operating income (loss)

    $

    26,516

     

     

    $

    4,886

     

     

    $

    108,353

     

     

    $

    (49,697)

     

     

     

     

     

     

     

     

     

    Gross margin

    28.3

    %

     

    20.5

    %

     

    33.2

    %

     

    16.6

    %

    Adjusted gross profit (Non-GAAP) (1)

    $

    108,167

     

     

    $

    115,434

     

     

    $

    256,546

     

     

    $

    277,711

     

    Adjusted gross margin (Non-GAAP) (2)

    35.3

    %

     

    34.5

    %

     

    38.9

    %

     

    38.7

    %

    Adjusted operating income (Non-GAAP)

    $

    61,835

     

     

    $

    64,748

     

     

    $

    164,335

     

     

    $

    161,567

     

    (1)

    Adjusted gross profit is calculated as net revenue less adjusted cost of goods sold.

    (2)

    Adjusted gross margin is calculated as adjusted gross profit divided by net revenue.

    Generics net revenue was $307 million in the second quarter of 2020 compared to $335 million for the prior year period. The reclassification of Oxymorphone to the Specialty segment and divestiture of our international business in 2019 accounted for $15 million of the quarter to quarter decline. In addition, new product launches in 2019 including EluRyng (Generic NuvaRing) and Sucralfate partially offset base portfolio erosion primarily related to Levothyroxine and Diclofenac Gel generic competition.

    Generics gross margin for the second quarter of 2020 was 28% compared to 20% for the prior year period. The increase primarily relates to new product launches and lower inventory related charges, partially offset by erosion and the reclassification of Oxymorphone. Generics adjusted gross margin for the second quarter of 2020 was 35% for the both the current and prior year period.

    Generics operating income for the second quarter of 2020 was $27 million compared to of $5 million for the prior year period. The increase primarily reflects the increase in gross margin described above and lower SG&A as well as R&D expenses due to cost reduction initiatives and the timing of expenses in 2020 due to delayed spending as a result of COVID-19.

    Generics adjusted operating income for the second quarter of 2020 was $62 million compared to $65 million for the prior year period primarily due to a reduction in Levothyroxine and Diclofenac revenue and the reclassification of Oxymorphone, partially offset by new product launches and a reduction of expenses as a result of cost saving initiatives and delayed spending as a result of COVID-19.

    Amneal Pharmaceuticals, Inc.

    Specialty Operating Results

    (Unaudited; In thousands)

     

    Specialty

    Three Months Ended

    June 30,

     

    Six Months Ended

    June 30,

     

    2020

     

    2019

     

    2020

     

    2019

    Net revenue - Specialty:

     

     

     

     

     

     

     

    Rytary®

    $

    38,389

     

     

    $

    33,000

     

     

    $

    76,235

     

     

    $

    61,828

     

    Unithroid®

    13,777

     

     

    8,904

     

     

    26,726

     

     

    18,625

     

    Zomig®

    12,060

     

     

    14,427

     

     

    24,488

     

     

    25,551

     

    All other specialty products

    30,030

     

     

    13,247

     

     

    54,784

     

     

    27,217

     

    Total net revenue – Specialty

    94,256

     

     

    69,578

     

     

    182,233

     

     

    133,221

     

    Cost of goods sold

    50,229

     

     

    32,958

     

     

    98,047

     

     

    63,823

     

    Gross profit

    44,027

     

     

    36,620

     

     

    84,186

     

     

    69,398

     

    Selling, general, and administrative

    16,870

     

     

    16,150

     

     

    37,812

     

     

    37,477

     

    Research and development

    5,256

     

     

    2,568

     

     

    12,601

     

     

    6,275

     

    (Gains) charges related to legal matters, net

    (1,750)

     

     

     

     

    250

     

     

     

    Intellectual property legal development expenses

     

     

     

     

    5

     

     

    1,045

     

    Other operating expenses, net

    82

     

     

    1,366

     

     

    82

     

     

    3,428

     

    Operating income

    $

    23,569

     

     

    $

    16,536

     

     

    $

    33,436

     

     

    $

    21,173

     

     

     

     

     

     

     

     

     

    Gross margin

    46.7

    %

     

    52.6

    %

     

    46.2

    %

     

    52.1

    %

    Adjusted gross profit (Non-GAAP) (1)

    $

    69,472

     

     

    $

    56,780

     

     

    $

    135,077

     

     

    $

    109,769

     

    Adjusted gross margin (Non-GAAP) (2)

    73.7

    %

     

    81.6

    %

     

    74.1

    %

     

    82.4

    %

    Adjusted operating income (Non-GAAP)

    $

    49,798

     

     

    $

    39,312

     

     

    $

    89,105

     

     

    $

    68,038

     

    (1)

    Adjusted gross profit is calculated as net revenue less adjusted cost of goods sold.

    (2)

    Adjusted gross margin is calculated as adjusted gross profit divided by net revenue.

    Specialty net revenue was $94 million in the second quarter of 2020 compared to $70 million for the prior year period, primarily due to the reclassification of Oxymorphone to the Specialty segment during the third quarter of 2019, and higher revenue from Rytary® and Unithroid®.

    Specialty gross margin for the second quarter of 2020 was 47% compared to 53% for the prior year period primarily due to product sales mix and the impact of Oxymorphone which is a lower margin product.

    Specialty adjusted gross margin for the second quarter of 2020 was 74% compared to 82% for the prior year period primarily due to the addition of lower margin Oxymorphone.

    Specialty operating income for the second quarter of 2020 was $24 million compared to $17 million for the prior year period, primarily due to higher revenue, partially offset by higher cost of goods sold and R&D expenditures, including IPX203.

    Specialty adjusted operating income for the second quarter of 2020 was $50 million compared to $39 million for the prior year period primarily due to the higher revenue.

    Amneal Pharmaceuticals, Inc.

    AvKARE Operating Results

    (Unaudited; In thousands)

     

    AvKARE (1)

    Three Months Ended

    June 30,

     

    Six Months Ended

    June 30,

     

    2020

     

    2019

     

    2020

     

    2019

    Net revenue - AvKARE (2)

    $

    63,847

     

     

    $

     

     

    $

    121,817

     

     

    $

     

    Cost of goods sold (2)

    50,528

     

     

     

     

    97,423

     

     

     

    Gross profit (2)

    13,319

     

     

     

     

    24,394

     

     

     

    Selling, general, and administrative

    15,647

     

     

     

     

    26,435

     

     

     

    Operating loss

    $

    (2,328)

     

     

    $

     

     

    $

    (2,041)

     

     

    $

     

     

     

     

     

     

     

     

     

    Gross margin

    20.9

    %

     

    %

     

    20.0

    %

     

    %

    Adjusted gross profit (Non-GAAP) (3)

    $

    13,319

     

     

    $

     

     

    $

    24,394

     

     

    $

     

    Adjusted gross margin (Non-GAAP) (3)

    20.9

    %

     

    %

     

    20.0

    %

     

    %

    Adjusted operating income (Non-GAAP)

    $

    5,682

     

     

    $

     

     

    $

    12,449

     

     

    $

     

    (1)

    The AvKARE segment includes the results of operations of AvKARE from January 31, 2020, the date of the acquisition, to June 30, 2020.

    (2)

    AvKARE excludes net revenue, costs of goods sold and gross profit from sales of Amneal products through this distribution channel. These financial results are included in the Generics segment.

    (3)

    There are no non-GAAP adjustments associated with gross profit and gross margin.

    Amneal Pharmaceuticals, Inc.

    Non-GAAP Reconciliations

    (Unaudited; In thousands)

     

    Reconciliations of Cost of Goods Sold to Adjusted Cost of Goods Sold

     

    Generics

    Three Months Ended

    June 30,

     

    Six Months Ended

    June 30,

     

    2020

     

    2019

     

    2020

     

    2019

    Cost of goods sold

    $

    218,909

     

     

    $

    263,423

     

     

    $

    437,774

     

     

    $

    542,301

     

    Cost of goods sold impairment charges

    759

     

     

    3,012

     

     

    2,215

     

     

    56,309

     

    Adjusted to deduct (add):

     

     

     

     

     

     

     

    Amortization

    10,521

     

     

    14,636

     

     

    21,171

     

     

    25,388

     

    Inventory related charges

    4,630

     

     

    21,443

     

     

    4,630

     

     

    21,777

     

    Acquisition and site closure expenses (1)

    2,540

     

     

    6,969

     

     

    5,572

     

     

    16,480

     

    Asset impairment charges (2)

    1,718

     

     

    3,012

     

     

    3,174

     

     

    56,309

     

    Stock-based compensation expense

    1,085

     

     

    813

     

     

    2,061

     

     

    1,409

     

    Amortization of upfront payment (4)

     

     

     

     

     

     

    36,393

     

    Other

    782

     

     

    (68)

     

     

    782

     

     

    1,024

     

    Adjusted cost of goods sold (Non-GAAP)

    $

    198,392

     

     

    $

    219,630

     

     

    $

    402,599

     

     

    $

    439,830

     

    Specialty

    Three Months Ended

    June 30,

     

    Six Months Ended

    June 30,

     

    2020

     

    2019

     

    2020

     

    2019

    Cost of goods sold

    $

    50,229

     

     

    $

    32,958

     

     

    $

    98,047

     

     

    $

    63,823

     

    Adjusted to deduct:

     

     

     

     

     

     

     

    Amortization

    25,445

     

     

    20,160

     

     

    50,891

     

     

    40,371

     

    Adjusted cost of goods sold (Non-GAAP)

    $

    24,784

     

     

    $

    12,798

     

     

    $

    47,156

     

     

    $

    23,452

     

    Amneal Pharmaceuticals, Inc.

    Non-GAAP Reconciliations

    (Unaudited; In thousands)

     

    Reconciliations of Operating Income (Loss) to Adjusted Operating Income

     

    Generics

    Three Months Ended

    June 30,

     

    Six Months Ended

    June 30,

     

    2020

     

    2019

     

    2020

     

    2019

    Operating income (loss)

    $

    26,516

     

     

    $

    4,886

     

     

    $

    108,353

     

     

    $

    (49,697)

     

    Adjusted to add (deduct):

     

     

     

     

     

     

     

    Acquisition and site closure expenses (1)

    4,188

     

     

    10,885

     

     

    8,788

     

     

    29,670

     

    Amortization

    10,521

     

     

    14,636

     

     

    21,171

     

     

    25,388

     

    Inventory related charges

    4,630

     

     

    21,443

     

     

    4,630

     

     

    21,777

     

    Stock-based compensation expense

    2,219

     

     

    3,875

     

     

    3,877

     

     

    5,373

     

    Asset impairment charges (2)

    2,299

     

     

    3,059

     

     

    4,774

     

     

    79,211

     

    Restructuring and other charges (3)

    332

     

     

    418

     

     

    378

     

     

    2,499

     

    Charges related to legal matters

    3,050

     

     

     

     

    5,550

     

     

     

    Amortization of upfront payment (4)

     

     

     

     

     

     

    36,393

     

    R&D milestone payment

    6,841

     

     

    5,614

     

     

    6,841

     

     

    9,929

     

    Other

    1,239

     

     

    (68)

     

     

    (27)

     

     

    1,024

     

    Adjusted operating income (Non-GAAP)

    $

    61,835

     

     

    $

    64,748

     

     

    $

    164,335

     

     

    $

    161,567

     

    Specialty

    Three Months Ended

    June 30,

     

    Six Months Ended

    June 30,

     

    2020

     

    2019

     

    2020

     

    2019

    Operating income

    $

    23,569

     

     

    $

    16,536

     

     

    $

    33,436

     

     

    $

    21,173

     

    Adjusted to add (deduct):

     

     

     

     

     

     

     

    Amortization

    25,445

     

     

    20,159

     

     

    50,891

     

     

    40,371

     

    Acquisition and site closure expenses (1)

    83

     

     

    2,251

     

     

    83

     

     

    5,806

     

    Stock-based compensation expense

    717

     

     

    366

     

     

    1,326

     

     

    510

     

    Restructuring and other charges (3)

     

     

     

     

     

     

    178

     

    R&D milestone payment

     

     

     

     

    2,000

     

     

     

    Other

    (16)

     

     

     

     

    1,369

     

     

     

    Adjusted operating income (Non-GAAP)

    $

    49,798

     

     

    $

    39,312

     

     

    $

    89,105

     

     

    $

    68,038

     

    AvKARE

    Three Months Ended

    June 30,

     

    Six Months Ended

    June 30,

     

    2020

     

    2019

     

    2020

     

    2019

    Operating loss

    $

    (2,328)

     

     

    $

     

     

    $

    (2,041)

     

     

    $

     

    Adjusted to add:

     

     

     

     

     

     

     

    Amortization

    8,010

     

     

     

     

    14,490

     

     

     

    Adjusted operating income (Non-GAAP)

    $

    5,682

     

     

    $

     

     

    $

    12,449

     

     

    $

     

    Amneal Pharmaceuticals, Inc.

    Non-GAAP Reconciliations

    (Unaudited; In thousands, except per share amounts)

     

    Reconciliation of Net (Loss) Income to Adjusted Net Income and Calculation of Adjusted Diluted EPS

     

     

    Three Months Ended

    June 30,

     

    Six Months Ended

    June 30,

     

    2020

     

    2019

     

    2020

     

    2019

    Net (loss) income

    $

    (23,944)

     

     

    $

    (50,526)

     

     

    $

    97,573

     

     

    $

    (175,278)

     

    Adjusted to add (deduct):

     

     

     

     

     

     

     

    Non-cash interest

    1,998

     

     

    1,617

     

     

    3,864

     

     

    3,218

     

    GAAP Income tax expense (benefit)

    2,186

     

     

    (5,701)

     

     

    (105,987)

     

     

    (14,129)

     

    Amortization

    41,181

     

     

    34,796

     

     

    81,495

     

     

    65,759

     

    Stock-based compensation expense

    5,663

     

     

    6,224

     

     

    10,202

     

     

    10,571

     

    Acquisition and site closure expenses (1)

    5,650

     

     

    19,056

     

     

    12,628

     

     

    47,258

     

    Restructuring and other charges (3)

    333

     

     

    2,835

     

     

    2,381

     

     

    8,996

     

    Inventory related charges

    5,125

     

     

    21,443

     

     

    5,125

     

     

    21,777

     

    Charges related to legal matters (5)

    3,050

     

     

     

     

    5,550

     

     

     

    Asset impairment charges (2)

    2,299

     

     

    4,408

     

     

    4,774

     

     

    81,008

     

    Amortization of upfront payment (4)

     

     

     

     

     

     

    36,393

     

    Foreign exchange (gain) loss

    (3,466)

     

     

    (8,311)

     

     

    1,715

     

     

    (2,847)

     

    (Gain) loss on sale of international businesses, net (6)

    (123)

     

     

    1,888

     

     

    (123)

     

     

    (6,930)

     

    R&D milestone payments

    6,841

     

     

    5,614

     

     

    8,841

     

     

    9,929

     

    Other

    2,431

     

     

    491

     

     

    (238)

     

     

    1,583

     

    Income tax at 21%

    (10,969)

     

     

    (7,104)

     

     

    (27,974)

     

     

    (18,334)

     

    Net income attributable to NCI not associated with our Class B shares

    (305)

     

     

    (61)

     

     

    (1,544)

     

     

    (140)

     

    Adjusted net income (Non-GAAP)

    $

    37,950

     

     

    $

    26,669

     

     

    $

    98,282

     

     

    $

    68,834

     

    Adjusted diluted EPS (Non-GAAP) (7)

    $

    0.13

     

     

    $

    0.09

     

     

    $

    0.33

     

     

    $

    0.23

     

    Amneal Pharmaceuticals, Inc.

    Non-GAAP Reconciliations

    (Unaudited, In thousands)

     

    Reconciliation of Net (Loss) Income to EBITDA and Adjusted EBITDA

     

     

    Three Months Ended

    June 30,

     

    Six Months Ended

    June 30,

     

    2020

     

    2019

     

    2020

     

    2019

    Net (loss) income

    $

    (23,944)

     

     

    $

    (50,526)

     

     

    $

    97,573

     

     

    $

    (175,278)

     

    Adjusted to add (deduct):

     

     

     

     

     

     

     

    Interest expense, net

    36,669

     

     

    43,886

     

     

    76,568

     

     

    87,167

     

    Income tax expense (benefit)

    2,186

     

     

    (5,701)

     

     

    (105,987)

     

     

    (14,129)

     

    Depreciation and amortization

    58,072

     

     

    50,706

     

     

    116,155

     

     

    99,574

     

    EBITDA (Non-GAAP)

    $

    72,983

     

     

    $

    38,365

     

     

    $

    184,309

     

     

    $

    (2,666)

     

    Adjusted to add (deduct):

     

     

     

     

     

     

     

    Stock-based compensation expense

    5,663

     

     

    6,224

     

     

    10,202

     

     

    10,571

     

    Acquisition and site closure expenses (1)

    5,650

     

     

    19,056

     

     

    12,628

     

     

    47,258

     

    Restructuring and other charges (3)

    333

     

     

    2,835

     

     

    2,381

     

     

    8,996

     

    Inventory related charges

    5,125

     

     

    21,443

     

     

    5,125

     

     

    21,777

     

    Charges related to legal matters (5)

    3,050

     

     

     

     

    5,550

     

     

     

    Asset impairment charges (2)

    2,299

     

     

    4,408

     

     

    4,774

     

     

    81,008

     

    Amortization of upfront payment (4)

     

     

     

     

     

     

    36,393

     

    Foreign exchange (gain) loss

    (3,466)

     

     

    (8,311)

     

     

    1,715

     

     

    (2,847)

     

    (Gain) loss on sale of international businesses, net (6)

    (123)

     

     

    1,888

     

     

    (123)

     

     

    (6,930)

     

    R&D milestone payments

    6,841

     

     

    5,614

     

     

    8,841

     

     

    9,929

     

    Other

    2,431

     

     

    559

     

     

    (238)

     

     

    559

     

    Adjusted EBITDA (Non-GAAP)

    $

    100,786

     

     

    $

    92,081

     

     

    $

    235,164

     

     

    $

    204,048

     

    Amneal Pharmaceuticals, Inc.

    Non-GAAP Reconciliations

    (Unaudited; In thousands)

    1. Acquisition and site closure expenses for the three and six months ended June 30, 2020, include costs related to: (i) system integration associated with the combination with Impax Laboratories, LLC, (ii) integration and transaction activities associated with the acquisition of AvKARE, and (iii) the planned cessation of manufacturing at our Hauppauge, NY facility. Acquisition and site closure expenses for the three and six months ended June 30, 2019 include costs related to: (i) the planned cessation of manufacturing at our Hauppauge, NY facility and redundant employee costs and (ii) the combination with Impax and related integration including legal, investment banking, accounting and information technology.
    2. Asset impairment charges for the three and six months ended June 30, 2020 are associated with equipment and intangible assets. Asset impairment charges for the three and six months ended June 20, 2019 are primarily associated with in-process research and development and intangible assets.
    3. For the three months ended June 30, 2020, restructuring and other charges primarily consisted of cash severance charges associated with cost of benefits for management employees. For the six months ended June 30, 2020, restructuring and other charges primarily consisted of cash severance charges associated with cost of benefits for former senior executives and management employees. For the three and six months ended June 30, 2019, restructuring and other charges are primarily associated with cash severance associated with the cost of benefits for former senior executives and cash severance provided pursuant to our severance programs for employees at Hayward, CA and other facilities.
    4. Amortization of upfront payment represents the amortization of the upfront payment made to Lannett in connection with our Transition Agreement for Levothyroxine.
    5. For the three and six months ended June 30, 2020, charges related to legal matters were approximately $3 million and $6 million, respectively, for commercial legal claims in our Generics segment.
    6. For the three and six months ended June 30, 2020, gain on the sale of international businesses, net was immaterial. For the three months ended June 30, 2019, loss on the sale of international businesses, net represents the loss from the sale of our Amneal Deutschland GmbH subsidiary, which comprised substantially all of the Company's operations in Germany. For the six months ended June 30, 2019, gain on the sale of international businesses, net represents the gain from the sale of our Creo Pharma Holding Limited subsidiary, which comprised substantially all of the Company's operations in the United Kingdom, partially offset by the loss from the sale of our Amneal Deutschland GmbH subsidiary.
    7. For the three and six months ended June 30, 2020, utilizes weighted average diluted shares outstanding of 300,779 and 300,426, respectively, which consists of Class A shares and Class B shares under the if-converted method. For the three and six months ended June 30, 2019, utilizes weighted average diluted shares outstanding of 299,139 and 299,117, respectively, which consists of Class A & Class B shares under the if-converted method.

     

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  3. BRIDGEWATER, N.J., July 14, 2020 (GLOBE NEWSWIRE) -- Cosette Pharmaceuticals, Inc. ("Cosette" or the "Company"), a privately held specialty generic pharmaceutical company primarily focused on extended topical and suppository products, announced today the appointment of Apurva Saraf as President and Chief Executive Officer.

    "We are very pleased to welcome Apurva to the Cosette team. His deep knowledge of the pharmaceutical industry, along with his corporate strategy and business development experience, will be of great value as Cosette continues to expand its portfolio of differentiated complex products, both internally and through strategic collaborations," stated Sriram Venkataraman, Partner of Avista Capital Partners. "We are proud of Cosette's…

    BRIDGEWATER, N.J., July 14, 2020 (GLOBE NEWSWIRE) -- Cosette Pharmaceuticals, Inc. ("Cosette" or the "Company"), a privately held specialty generic pharmaceutical company primarily focused on extended topical and suppository products, announced today the appointment of Apurva Saraf as President and Chief Executive Officer.

    "We are very pleased to welcome Apurva to the Cosette team. His deep knowledge of the pharmaceutical industry, along with his corporate strategy and business development experience, will be of great value as Cosette continues to expand its portfolio of differentiated complex products, both internally and through strategic collaborations," stated Sriram Venkataraman, Partner of Avista Capital Partners. "We are proud of Cosette's unique corporate culture, consumer-centric focus, and emphasis on high-quality products and believe that Apurva will be the ideal leader to drive the next phase of the Company's growth," concluded Venkataraman.

    "I am excited for the opportunity to contribute to Cosette's growth and build upon its impressive portfolio of products. I look forward to working with the entire Cosette team as we remain steadfastly focused on ensuring our high-quality prescription and OTC products are consistently accessible to patients and caregivers," stated Apurva Saraf, President and Chief Executive Officer.

    Apurva brings more than 20 years of pharmaceutical experience in global corporate strategy and operations. Prior to joining Cosette, Apurva was part of Amneal Pharmaceutical's (NYSE:AMRX) executive leadership team with responsibility for global corporate development and strategic growth initiatives. He has broad experience in commercial operations across various channels and in negotiating and integrating merger and acquisition transactions globally. While at Amneal, Apurva also co-founded Gemini Laboratories, a successful endocrinology-focused specialty pharmaceuticals company. Before joining Amneal, Apurva served in positions of increasing responsibility at Ranbaxy USA. Prior to Ranbaxy, Apurva was an equity analyst with UBS, JPMorgan and Credit Suisse in New York, covering the US Specialty and Generic Pharmaceuticals sector. Apurva earned his MBA in Finance from Baruch College in New York and Bachelor of Commerce in Economics and Accounting from Bombay University.

    About Cosette Pharmaceuticals, Inc.

    Cosette Pharmaceuticals, Inc. is a specialty and generics pharmaceutical company specializing in the areas of dermatology and allergy, with products available in dosage forms such as creams, ointments, lotions, solutions, gels, pastes, suppositories and oral liquid products. The company was formed when Avista Capital Partners, a leading private equity firm focused on growth-oriented healthcare businesses, purchased the extended topicals and dermatology portfolio of G&W Laboratories in December 2018. Cosette is expanding its product offering by bringing new products to market via internal development and external licensing or acquisitions. For further information on Cosette, please visit the company's website, cosettepharma.com.

    Investor and Media Relations for Cosette Pharmaceuticals, Inc.

    Lisa M. Wilson

    In-Site Communications, Inc.

    T: 212-452-2793

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  4. FLORHAM PARK, N.J., July 13, 2020 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (NASDAQ:PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today announced that it has appointed Todd Branning as Chief Financial Officer.  Interim CFO, David Socks, will continue with the company as a strategic advisor and remain a member of the Board of Directors.

    Mr. Branning was most recently with Amneal Pharmaceuticals, Inc. (NYSE:AMRX) where he served as Senior Vice President and Chief Financial Officer.  He brings a diverse global finance background consisting of over 25 years of experience in corporate finance and accounting, tax, financial planning and analysis…

    FLORHAM PARK, N.J., July 13, 2020 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (NASDAQ:PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today announced that it has appointed Todd Branning as Chief Financial Officer.  Interim CFO, David Socks, will continue with the company as a strategic advisor and remain a member of the Board of Directors.

    Mr. Branning was most recently with Amneal Pharmaceuticals, Inc. (NYSE:AMRX) where he served as Senior Vice President and Chief Financial Officer.  He brings a diverse global finance background consisting of over 25 years of experience in corporate finance and accounting, tax, financial planning and analysis, and investor relations.

    "I am delighted to welcome Todd to Phathom and to have him join our executive leadership team.  As we continue to grow our organization and prepare for the potential commercialization of vonoprazan, Todd's expertise in finance and accounting will add great value to our company," said Terrie Curran, President and Chief Executive Officer of Phathom.  "I would also like to thank David for his many contributions to Phathom and am excited that we will continue to benefit from his expertise in business development and his involvement in other key strategic areas."

    Mr. Branning has extensive finance experience in the pharmaceutical industry.  As SVP, CFO at Amneal Pharmaceuticals, he helped to build, leverage, and optimize infrastructure following the completion of a transformational merger in May 2018.  Prior to Amneal Pharmaceuticals, he served as Senior Vice President, Chief Financial Officer for Teva Pharmaceuticals' (NYSE:TEVA) Global Generic Medicines division.  Mr. Branning led the finance function and served on the leadership team responsible for managing the day-to-day operations of Teva's largest multi-billion dollar commercial unit.  Prior to joining Teva in 2016, he served as Vice President, Finance, for Allergan plc.  Mr. Branning has also served in financial leadership roles at PricewaterhouseCoopers, PPG Industries, Inc. and Merck & Co., Inc.

    Mr. Branning holds an MBA degree from Carnegie Mellon University and a BBA from the University of Miami.  He is a Certified Public Accountant and has completed a CFO certification program from The Wharton School at the University of Pennsylvania.  

    About Vonoprazan

    Vonoprazan is an oral small molecule potassium-competitive acid blocker (P-CAB). P-CABs are a novel class of medicines that block acid secretion in the stomach. Vonoprazan has shown the potential to have rapid, potent, and durable anti-secretory effects as a single agent in the treatment of gastroesophageal reflux disease (GERD) and in combination with antibiotics for the treatment of Helicobacter pylori (H. pylori) infection. The U.S. Food and Drug Administration (FDA) has designated vonoprazan as a qualified infectious disease product (QIDP) and awarded Fast Track status for the treatment of H. pylori infection in combination with both amoxicillin and clarithromycin and with amoxicillin alone. Phathom in-licensed the U.S., European, and Canadian rights to vonoprazan from Takeda, which completed 18 Phase 3 trials for vonoprazan and received marketing approval in 13 countries in Asia and Latin America.

    About Phathom

    Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases and disorders. Phathom has in-licensed the exclusive rights in the United States, Europe, and Canada to vonoprazan, a novel potassium competitive acid blocker (P-CAB) in late-stage development for the treatment of acid-related disorders. For more information about Phathom, visit the company's website at www.phathompharma.com or follow the Company on LinkedIn at www.linkedin.com/company/phathompharma.

    CONTACTS

    Joe Hand

    1-877-742-8466

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    Nick Benedetto

    1-877-742-8466

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  5. Amneal Pharmaceuticals, Inc. (NYSE:AMRX) ("Amneal" or the "Company") today announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for a generic version of Fluphenazine Hydrochloride Tablets USP, 1 mg, 2.5 mg, 5 mg, and 10 mg. Fluphenazine Hydrochloride is the generic version of Prolixin for treatment of schizophrenia. Amneal immediately initiated commercialization activities across all dosages.

    According to IQVIA™, a leading healthcare data and analytics provider, U.S. annual sales for Fluphenazine Hydrochloride Tablets for the 12 months ended May 2020 were approximately $143 million.

    About Amneal

    Amneal Pharmaceuticals, Inc. (NYSE:AMRX), headquartered in Bridgewater…

    Amneal Pharmaceuticals, Inc. (NYSE:AMRX) ("Amneal" or the "Company") today announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for a generic version of Fluphenazine Hydrochloride Tablets USP, 1 mg, 2.5 mg, 5 mg, and 10 mg. Fluphenazine Hydrochloride is the generic version of Prolixin for treatment of schizophrenia. Amneal immediately initiated commercialization activities across all dosages.

    According to IQVIA™, a leading healthcare data and analytics provider, U.S. annual sales for Fluphenazine Hydrochloride Tablets for the 12 months ended May 2020 were approximately $143 million.

    About Amneal

    Amneal Pharmaceuticals, Inc. (NYSE:AMRX), headquartered in Bridgewater, NJ, is a fully-integrated pharmaceutical company focused on the development, manufacturing and distribution of generic and specialty drug products. The Company has operations in North America, Asia, and Europe, working together to bring high-quality medicines to patients primarily within the United States.

    Amneal has an extensive portfolio of approximately 250 product families and is expanding its portfolio to include complex dosage forms, including biosimilars, in a broad range of therapeutic areas. The Company also markets a portfolio of branded pharmaceutical products through its Specialty segment focused principally on central nervous system and endocrine disorders.

    The Company also owns 65% of AvKARE. AvKARE provides pharmaceuticals, medical and surgical products and services primarily to governmental agencies, primarily focused on serving the Department of Defense and the Department of Veterans Affairs. AvKARE is also a packager and wholesale distributor of pharmaceuticals and vitamins to its retail and institutional customers who are located throughout the United States focused primarily on offering 340b-qualified entities products to provide consistency in care and pricing. For more information, visit www.amneal.com.

    Forward-Looking Statements

    Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the Private Securities Litigation Reform Act of 1995, as amended). Such forward-looking statements include statements regarding management's intentions, plans, beliefs, expectations or forecasts for the future, including, among other things, future operating results and financial performance, product development and launches, integration strategies and resulting cost reduction, market position and business strategy. Words such as "may," "will," "could," "expect," "plan," "anticipate," "intend," "believe," "estimate," "assume," "continue," and similar words are intended to identify estimates and forward-looking statements.

    The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Amneal. A list and descriptions of these risks, uncertainties and other factors can be found in the Company's most recently filed Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as supplemented by any subsequently filed Quarterly Reports on Form 10-Q. Copies of these filings are available online at www.sec.gov, www.amneal.com or on request from the Company.

    Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof, except as otherwise required by United States securities laws.

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