DOCSLIB.ORG

Bausch Health 2019 Annual Report

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text

Load more

BAUSCH HEALTH COMPANIES INC. Pivot to BAUSCH HEALTH COMPANIES INC. Offense 2019 ANNUAL REPORT 2019 ANNUAL REPORT Quality Customer Health Care Focused Our Vision Outcomes To Be Your Trusted Core Health Care Partner Principles CORE VALUES • Accountability People Innovation • Agility • Courage • Integrity • Teamwork • Results Orientation Effciency Our Mission Improving People’s Lives With Our Health Care Products COMPANY OVERVIEW We are a global company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of branded, generic and branded generic pharmaceuticals, medical devices (contact lenses, intraocular lenses, ophthalmic surgical equipment and aesthetics devices) and over-the- counter (OTC) products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. More information can be found at www.bauschhealth.com. FORWARD-LOOKING STATEMENTS This annual report contains forward-looking information and statements, within the meaning of applicable securities laws (collectively, “forward-looking statements”), including, but not limited to, statements regarding the Company’s future prospects and performance, anticipated product launches and geographic expansion and the expected timing of such launches and expansion, anticipated timing for the submission of certain of our pipeline products and R&D programs, anticipated advances in our development programs and pipeline products, and expectations regarding leveraging our IBS and other portfolios. Forward-looking statements may generally be identified by the use of the words “anticipates,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “will,” “believes,” “estimates,” “potential,” “target,” or “continue” and variations or similar expressions, and phrases or statements that certain actions, events or results may, could, should or will be achieved, received or taken, or will occur or result, and similar such expressions also identify forward-looking information. These forward-looking statements, including the Company’s future performance and growth, are based upon the current expectations and beliefs of management and are provided for the purpose of providing additional information about such expectations and beliefs, and readers are cautioned that these statements may not be appropriate for other purposes. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in the Company’s most recent annual or quarterly report and detailed from time to time in the Company’s other filings with the Securities and Exchange Commission and the Canadian Securities Administrators, which risks and uncertainties are incorporated herein by reference. In addition, certain material factors and assumptions have been applied in making these forward-looking statements, including, without limitation, the assumption that the risks and uncertainties outlined above will not cause actual results or events to differ materially from those described in these forward-looking statements, and additional information regarding certain of these material factors and assumptions may also be found in the Company’s filings described above. The Company believes that the material factors and assumptions reflected in these forward-looking statements are reasonable in the circumstances, but readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch Health undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this annual report or to reflect actual outcomes, unless required by law. THE BAUSCH FOUNDATION Improving Lives Around the World The Bausch Foundation was established in 2017 to improve the lives of people around the world by providing access to safe, effective medicines and by financially supporting health care education and causes. The Bausch Foundation is a charitable foundation that oversees and directs all of Bausch Health’s global charitable giving. The Bausch Foundation supports initiatives aimed at disease prevention, improving patient outcomes and lives, and education related to our core businesses. Additionally, it supports disaster-recovery efforts and those who need help in the communities where we live and work. Our goal is to direct efforts toward contributions that can be repeatable, gather critical mass and make important benefits within our therapeutic communities. Since its inception, the Bausch Foundation has contributed millions of dollars’ worth of financial and product donations to global charitable health organizations, including: 2019 Annual Report 1 BAUSCH HEALTH COMPANIES INC. Fellow Shareholders, We entered 2019 with ambitious goals, and I am Pivot to Offense Yields Results pleased to report that our team has continued to In 2019, our shift to offense was driven by innovative new products, further debt paydown and business development make significant progress in delivering on our com- opportunities designed to enhance our core businesses and mitments to transform Bausch Health. Our “pivot to expand our product portfolio and pipeline. Within each of our three offense” strategy enabled us to add several important, core businesses, there were several important achievements, as well as strategic business development opportunities, that were complementary products to our core businesses completed for less than $250 million. Among these include: through acquisitions or licensing agreements. Bausch + Lomb/International Today, Bausch Health is a diverse, global company that develops, √ Launched Bausch + Lomb ULTRA® Multi-Focal for Astigmatism manufactures and markets a wide range of pharmaceutical, contact lenses, Zen Multifocal and Tangible Science Hydra-PEG® medical device and over-the-counter products. Each of our coating contact lenses, PreserVision® AREDS2 Formula Minigel Eye businesses is independently strong, durable and well-positioned to Vitamins, Ocuvite® Eye Performance vitamins and LOTEMAX® SM capitalize on the megatrends that are driving growth in the thera- (loteprednol etabonate ophthalmic gel) 0.38% for treating peutic areas of eye health, gastroenterology and dermatology. inflammation and pain following eye surgery √ Continued the expansion of our daily disposable contact lens During 2019, we delivered on the following key commitments: parameter offerings • Grew reported total Company revenue for the year (compared √ Acquired EM-100, an investigational eye drop that, if approved, with 2018); will be the first over-the-counter preservative-free eye drop • Generated $1.5 billion in cash from operations, and used more for the treatment of itchy eyes associated with allergies than $1 billion to reduce debt and make “bolt-on” acquisitions; √ Licensed in XIPERE™, an investigational treatment for macular • Grew R&D investment by 14 percent in 2019 versus 2018; and edema associated with uveitis that will be resubmitted to the • Improved operational efficiency, resulting in approximately U.S. Food and Drug Administration (FDA) for review $75 million of operating profit. √ Licensed in NOV03, an investigational first-in-class medicine In addition, we settled the U.S. securities class action litigation, with a novel mechanism of action to treat Dry Eye Disease also known as the “Valeant stock drop” case, which was one of associated with Meibomian gland dysfunction the largest remaining legacy liabilities we needed to address. Salix Pharmaceuticals Still subject to final court approval, this settlement removes a √ Acquired TRULANCE® (plecanatide), a treatment for adults with cloud of uncertainty and gives current and future stakeholders chronic idiopathic constipation and irritable bowel syndrome confidence in the ongoing turnaround of Bausch Health. with constipation We continued to deliver on our commitment to create share- √ Acquired dolcanatide, an investigational compound that has holder value as our stock price significantly outperformed the demonstrated proof-of-concept in treating patients with broader market. Bausch Health stock rose 62 percent for the multiple gastrointestinal conditions year, compared with Standard & Poor’s 500 (+29 percent), the √ Entered into an exclusive licensing agreement for MT-1303 Toronto Stock Exchange (+25 percent), the Dow Jones Industrial (amiselimod), a late-stage investigational sphinogosine Average (+22 percent) and the New York Stock Exchange Arca 1-phosphate (S1P) modulator for the treatment of inflammatory Pharmaceutical Index (+15 percent). We also saw several positive bowel disease upgrades or initiations from the sell-side. √ Entered into a licensing agreement with the University of California, Los Angeles, to develop and commercialize an early- stage novel investigational compound for the treatment of non- alcoholic fatty liver disease and non-alcoholic steatohepatitis 2 Bausch Health Companies Inc. Ortho Dermatologics √ Launched DUOBRII® (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%, a treatment for plaque psoriasis √ Continued the launch of Thermage FLX®, an aesthetic We are building a world-class skin-tightening
Recommended publications
  • Abbvie Allergan Acquisition

    Abbvie Allergan Acquisition

    Creating a New Diversified Biopharmaceutical Company The Combination of AbbVie and Allergan Investor Presentation June 25, 2019 NO OFFER OR SOLICITATION This presentation is not intended to and does not constitute an offer to sell or the solicitation of an offer to subscribe for or buy or an invitation to purchase or subscribe for any securities or the solicitation of any vote or approval in any jurisdiction pursuant to the acquisition or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. In particular, this presentation is not an offer of securities for sale into the United States. No offer of securities shall be made in the United States absent registration under the U.S. Securities Act of 1933, as amended, or pursuant to an exemption from, or in a transaction not subject to, such registration requirements. Any securities issued in the acquisition are anticipated to be issued in reliance upon available exemptions from such registration requirements pursuant to Section 3(a)(10) of the U.S. Securities Act of 1933, as amended. The acquisition will be made solely by means of the Scheme Document (or, if applicable, the Takeover Offer document), which will contain the full terms and conditions of the acquisition, including details with respect to the AbbVie shareholder vote in respect of the acquisition. Any decision in respect of, or other response to, the acquisition, should be made only on the basis of the information contained in the Scheme Document. IMPORTANT ADDITIONAL INFORMATION WILL BE FILED WITH THE SEC In connection with the proposed Acquisition, Allergan will file with the Securities Exchange Commission (the “SEC”) a Proxy Statement, which will include the Scheme Document.
  • Understanding the FTC's Monetary Equitable Remedies Under Section

    Understanding the FTC's Monetary Equitable Remedies Under Section

    Understanding the FTC’s monetary equitable remedies under Section 13(b) for antitrust violations By Gerald A. Stein, American Bar Association — Fall 2019 Until recently the Federal Trade Commission’s ability to seek monetary equitable remedies (particularly disgorgement and restitution) for alleged antitrust violations— whether ongoing, impending, or stale— went virtually unchallenged. After it first gained statutory authority under Section 13(b)1 of the FTC Act to bring suit in federal district court to preliminarily enjoin conduct that “is violating, or is about to violate” the antitrust laws, the FTC successfully convinced many federal courts that Section 13(b) also impliedly allowed the FTC to seek standalone permanent injunctions and monetary equitable remedies regardless of whether a defendant’s alleged anticompetitive conduct was ongoing or completed long ago.2 The FTC brought few antitrust cases in the years following the enactment for alleged antitrust violations pursuant to Section 13(b) where the alleged of Section 13(b) in 1973, and the agency formalized its conservative anticompetitive conduct was neither ongoing nor imminent. Next, in approach in its unanimously approved 2003 Policy Statement on Monetary FTC v. Credit Bureau Center LLC,5 the Seventh Circuit vacated an award for Equitable Remedies in Competition Cases. In 2012, however, the FTC restitution in a consumer protection case based on its determination that abruptly, and without providing an opportunity for public comment, Section 13(b) authorizes only restraining orders and injunctions. And, in a withdrew its 2003 Policy Statement, asserting that it created “an overly third case that is still pending, FTC v.
  • Inside Valeant's Fall

    Inside Valeant's Fall

    March 29, 2017 ROB MAGAZINE Inside Valeant’s fall How an analyst, a hedge fund manager and a journalist exposed the fatal flaws in CEO Michael Pearson’s strategy and ended a drug-fuelled capital markets rampage CHARLES WILLIAMS BRUCE LIVESEY SPECIAL TO THE GLOBE AND MAILLAST UPDATED: WEDNESDAY, MAR. 29, 2017 9:49AM EDT U.S. Senator Elizabeth Warren is renowned for pillorying captains of industry when the opportunity presents itself. Such an occasion arose one cool, overcast day in April of last year, when J. Michael Pearson sat in front of a group of senators in a wood-panelled chamber on Capitol Hill in Washington, D.C. As the recently fired (but still acting) CEO of Laval, Quebec-based Valeant Pharmaceuticals International Inc., Pearson was appearing before the Senate’s Special Committee on Aging to answer for Valeant’s penchant for jacking up drug prices to unholy levels. The room was packed with aides, reporters and anxious businesspeople. Warren, a Democrat from Massachusetts, is a former Harvard law professor with a rapier intelligence and a willingness to be blunt. At one point she drilled down on Valeant’s use of “patient assistance programs.” Warren felt that such programs—which typically cover some or all of a patient’s co-payment—were a cunning way to keep consumers using overpriced drugs after the company hiked prices. “What is the return to Valeant on the money that you’re currently putting into the patient assistance program?” Warren demanded pointedly. Pearson, a fleshy 57-year-old with grey hair and a long puffy face, was looking rather whipped despite his natty charcoal suit and burgundy tie.
  • Responding to Mylan's Inadequate Tender Offer

    Responding to Mylan's Inadequate Tender Offer

    Responding To Mylan’s Inadequate Tender Offer: Perrigo’s Board Recommends That You Reject the Offer and Do Not Tender September 2015 Important Information Forward Looking Statements Certain statements in this presentation are forward-looking statements. These statements relate to future events or the Company’s future financial performance and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “potential” or other comparable terminology. The Company has based these forward-looking statements on its current expectations, assumptions, estimates and projections. While the Company believes these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond the Company’s control, including future actions that may be taken by Mylan in furtherance of its unsolicited offer. These and other important factors, including those discussed under “Risk Factors” in the Perrigo Company’s Form 10-K for the year ended June 27, 2015, as well as the Company’s subsequent filings with the Securities and Exchange
  • Print Layout 1

    Print Layout 1

    TECHNICAL PROGRAM Monday, March 19 5:00 – 8:00 pm Welcome Reception Tuesday, March 20 8:00 – 10:00 Session 1: Setting the Conference Context and Drivers Chair: Geoff Slaff (Amgen) Roger Perlmutter (Amgen) Conquering the Innovation Deficit in Drug Discovery Helen Winkle (CDER, FDA) Regulatory Modernization 10:00 – 10:30 Break Vendor and poster review 10:30 – 12:30 Session 2: Rapid Cell Line Development and Improved Expression System Development Chairs: Timothy Charlebois (Wyeth) and John Joly (Genentech) Amy Shen (Genentech) Stable Antibody Production Cell-Line Development with an Improved Selection Process and Accelerated Timeline Mark Leonard (Wyeth) High-Performing Cell-Line Development within a Rapid and Integrated Platform Process Control Pranhitha Reddy (Amgen) Applying Quality-by-Design to Cell Line Development Lin Zhang (Pfizer) Development of a Fully-Integrated Automated System for High-Throughput Screening and Selection of Single Cells Expressing Monoclonal Antibodies 12:30 – 2:00 Lunch Vendor and poster review 2:00 – 4:30 Session 3: High-Throughput Bulk Process Development Chairs: Brian Kelley (Wyeth) and Jorg Thommes (Biogen Idec) Colette Ranucci (Merck) Development of a Multi-Well Plate System for High-Throughput Process Development Min Zhang (SAFC Biosciences) CHO Media Library – an Efficient Platform for Rapid Development and Optimization of Cell Culture Media Supporting High Production of Pharmaceutical Proteins in Chinese Hamster Ovary Cells Nigel Titchener-Hooker The Use of Ultra-Scale-Down Approaches to Enable Rapid Investigation
  • Recommendations for the Primary Analysis of Continuous Endpoints in Longitudinal Clinical Trials

    Recommendations for the Primary Analysis of Continuous Endpoints in Longitudinal Clinical Trials

    02-DIJ42(4) 2348.qxd 6/9/08 1:46 PM Page 303 STATISTICS 303 Recommendations for the Primary Analysis of Continuous Endpoints in Longitudinal Clinical Trials Craig H. Mallinckrodt, PhD Research Advisor, Lilly This position paper summarizes relevant theo- simple methods in favor of joint analysis of Research Laboratories, Eli ry and current practice regarding the analysis data from all time points based on a multivari- Lilly and Company, of longitudinal clinical trials intended to sup- ate model (eg, of a mixed-effects type). One Indianapolis, Indiana port regulatory approval of medicinal prod- such newer method, a likelihood-based mixed- Peter W. Lane, MA, CStat ucts, and it reviews published research regard- effects model repeated measures (MMRM) ap- Director of Consultancy and Training, Research Statistics ing methods for handling missing data. It is proach, has received considerable attention in Unit, GlaxoSmithKline, one strand of the PhRMA initiative to improve the clinical trials literature. We discuss specif- Harlow, United Kingdom efficiency of late-stage clinical research and ic concerns raised by regulatory agencies with Dan Schnell, PhD gives recommendations from a cross-industry regard to MMRM and review published evi- Section Head, Pharmaceutical Statistics, team. We concentrate specifically on continu- dence comparing LOCF and MMRM in terms Procter & Gamble ous response measures analyzed using a linear of validity, bias, power, and type I error. Our Pharmaceuticals, model, when the goal is to estimate and test main conclusion is that the mixed model ap- Mason, Ohio treatment differences at a given time point. proach is more efficient and reliable as a Yahong Peng, PhD Traditionally, the primary analysis of such tri- method of primary analysis, and should be Senior Biometrician, Clinical Biostatistics, Merck als handled missing data by simple imputation preferred to the inherently biased and statisti- Research Lab, Upper using the last, or baseline, observation carried cally invalid simple imputation approaches.
  • Pfizer and Mylan Will Own 57% and 43% of the New Company (“Newco”), Respectively

    Pfizer and Mylan Will Own 57% and 43% of the New Company (“Newco”), Respectively

    DEAL PROFILE PFIZER | MYLAN VALUES 57% 43% $12.0bn PFIZER SHARE OF NEWCO MYLAN SHARE OF NEWCO NEW DEBT RAISED Pfizer Inc. (NYSE:PFE) Pfizer Inc. (“Pfizer”) is a pharmaceutical company that develops, manufactures, and sells products in internal medicine, vaccines, oncology, inflammation & immunology, and rare diseases. Upjohn, a subsidiary of Pfizer, is composed of Pfizer’s oral solid generics and off-patent drugs franchise, such as Viagra, Lipitor, and Xanax. Upjohn has a strong focus in emerging markets, and is headquartered in Shanghai, China. TEV: $265.4bn LTM EBITDA: $22.5bn LTM Revenue: $55.7bn Mylan N.V. (NASDAQ:MYL) Mylan N.V. (“Mylan”) is a pharmaceutical company that develops, manufactures, and commercializes generic, branded-generic, brand-name, and over-the-counter products. The company focuses in the following therapeutic areas: cardiovascular, CNS and anesthesia, dermatology, diabetes and metabolism, gastroenterology, immunology, infectious disease, oncology, respiratory and allergy, and women’s health. Mylan was founded in 1961 and is headquartered in Canonsburg, PA. TEV: $23.9bn LTM EBITDA: $3.5bn LTM Revenue: $11.3bn Bourne Partners provides strategic and financial advisory services to BOURNE clients throughout the business evolution life cycle. In order to provide PARTNERS the highest level of service, we routinely analyze relevant industry MARKET trends and transactions. These materials are available to our clients and partners and provide detailed insight into the pharma, pharma services, RESEARCH OTC, consumer health, and biotechnology sectors. On July 29, 2019, Pfizer announced the spin-off of its off-patent drug unit, Upjohn, in order to merge the unit with generic drug manufacturer, Mylan.
  • Final Attendee List

    Final Attendee List

    Jennifer Abnet GlaxoSmithKline I GlaxoSmithKline I Jane Arboleda APRN Guardant I Molly Benson Sanjiv Agarwala MD Puma Biotechnology I Cancer Expert Now I Joe Arminger AbbVie I Seth Berkowitz LCSW, Manmeet Ahluwalia MD, CCLS MBA Patricia Armstrong The Leukemia & Lymphoma Miami Cancer Institute I Novartis I Society V Steve Albers Kim Arnold APRN CPNP Barry Berman MD, MS Alexion V CPHON Florida Cancer Specialists I Servier Pharmaceuticals I Maritza Alencar DNP, Tizano Bernard MBA, APRN, BMTCN Sheila Arrington MSN, Cancer Care Centers of Miami Cancer Institute V APRN, NP-C, AOCN Brevard I Puma Biotechnology I Carmen Allen MSIT Ana Mari Bernardini Pharmavoxx V Shannon Ashmon Novartis Oncology I Eisai, Inc I Luly Almeida Bernard Berry MBA Incyte Corporation I Sarah Ashton MS AstraZeneca Pharmaceuticals Guardant Health I I Talat Almukhtar MD Orlando Health Cancer Melissa Austin Jason Bever Institute I Cancer Care Centers of Oncopeptides I Brevard I Beatrice Alvarado Roberts Amy Bignon MD Garland Avera Doyle Caris Life Sciences I University of Florida I Jazz Pharmaceuticals I Nadeem Bilani MD Tadeu Ambros MD Francie Babcock Cleveland Clinic I FCS I AMAG Pharmaceuticals/Covis I Angela Bilik RN BSN Douglas Anderson AstraZeneca I Incyte Corporation I Craig Bailey Astra Zeneca I Jamie Bilsky BS Blesson Andrews Genentech V Genentech I Kevin Barr Daiichi Sankyo I Rohit Bishnoi MD Ollie Annum PharmD University of Florida I BHMCR I Leonard Bennett PharmD EMD Serono I Brady Blackman Susmitha Apuri MD MorphoSys I Florida Cancer Specialists I Michael Bennett As of 4-22-21 Kimberly Blandon RN MSN Rick Breitenstein Memorial Cancer Institute I Apellis Pharmaceuticals I Denise Capo Karyopharm Therapeutics I Taryn Boiteau GlaxoSmithKline I Amanda Bridges Florida Society of Clinical Heidi Caravetta Tracy Bonds RN, BSN, Oncology I Exelixis, Inc.
  • Faculty Disclosure

    Faculty Disclosure

    Faculty Disclosure In accordance with the ACCME Standards for Commercial Support, course directors, planning committees, faculty and all others in control of the educational content of the CME activity must disclose all relevant financial relationships with any commercial interest that they or their spouse/partner may have had within the past 12 months. If an individual refuses to disclose relevant financial relationships, they will be disqualified from being a part of the planning and implementation of this CME activity. Owners and/or employees of a commercial interest with business lines or products relating to the content of the CME activity will not be permitted to participate in the planning or execution of any accredited activity. Nature of Relevant Financial Relationship Last Name Commercial Interest What Was Received For What Role AbbVie, Allergan/ Tobira Therapeutics Inc, Gilead Research Grant Research Balart Sciences Inc, Pfizer, Salix Pharmaceuticals AbbVie, Merck Honorarium Advisory Board Bau None N/A N/A Benz None N/A N/A AbbVie, Arbutus Biopharma, Dieterich Gilead Sciences, Inc., Bristol- Research Grant Consultant Myers Squibb, Merck Bayer HealthCare Pharmaceuticals, Gilead Sciences Honorarium Speaking, Consultant Inc. Bristol-Myers Squibb, Gilead Speaking, Advisory Sciences, Inc, Salix Honorarium Frenette Board Pharmaceuticals, Inc, Merck Intercept Pharmaceuticals Honorarium Advisor Conatus Pharmaceuticals Inc Honorarium Consulting Principle Investigator, Research Grant, Han Gilead Sciences,
  • Endo Pharmaceuticals Inc. V. Actavis

    Endo Pharmaceuticals Inc. V. Actavis

    United States Court of Appeals for the Federal Circuit ______________________ ENDO PHARMACEUTICALS INC., MALLINCKRODT LLC, Plaintiffs-Appellees v. ACTAVIS LLC, FKA ACTAVIS INC., ACTAVIS SOUTH ATLANTIC LLC, TEVA PHARMACEUTICALS USA, INC., Defendants-Appellants ______________________ 2018-1054 ______________________ Appeal from the United States District Court for the District of Delaware in No. 1:14-cv-01381-RGA, Judge Richard G. Andrews. ______________________ Decided: May 3, 2019 ______________________ MARTIN JAY BLACK, Dechert LLP, Philadelphia, PA, ar- gued for plaintiffs-appellees. Also represented by SHARON K. GAGLIARDI; BLAKE GREENE, Austin, TX; JONATHAN LOEB, Mountain View, CA; ROBERT RHOAD, Princeton, NJ. JEFFREY J. TONEY, Kasowitz, Benson, Torres & Fried- man LLP, Atlanta, GA, for plaintiff-appellee Mallinckrodt LLC. Also represented by RODNEY R. MILLER, PAUL GUNTER WILLIAMS. 2 ENDO PHARM. INC. v. ACTAVIS LLC JOHN C. O'QUINN, Kirkland & Ellis LLP, Washington, DC, argued for defendants-appellants. Also represented by WILLIAM H. BURGESS; CHARLES A. WEISS, ERIC H. YECIES, Holland & Knight, LLP, New York, NY. ______________________ Before WALLACH, CLEVENGER, and STOLL, Circuit Judges. Opinion for the court filed by Circuit Judge WALLACH. Dissenting opinion filed by Circuit Judge STOLL. WALLACH, Circuit Judge. Appellees Endo Pharmaceuticals Inc. (“Endo Pharma- ceuticals”) and Mallinckrodt LLC (“Mallinckrodt”) (collec- tively, “Endo”) sued Appellants Actavis LLC, Actavis South Atlantic LLC, and Teva Pharmaceuticals USA, Inc. (collec- tively, “Actavis”) in the U.S. District Court for the District of Delaware (“District Court”), alleging that two Abbrevi- ated New Drug Applications filed by Actavis infringed claims 1–6 (“the Asserted Claims”) of Mallinckrodt’s U.S. Patent No. 8,871,779 (“the ’779 patent”), which Endo Phar- maceuticals licenses.
  • Q1 Pharma Sector Snapshot

    Q1 Pharma Sector Snapshot

    SPECIALTY & GENERIC PHARMA Q1 2021 Report Market Commentary – Debt Capital Markets Debt Markets ▪ 2020 saw increased amounts of debt used in buyouts across the board, resulting in the highest debt / EBITDA Median US Buyout Multiples levels since 2014 − The increased use of debt was driven by 2H20 back- end loaded lending activity (primarily 4Q20) as 16.0x 12.7x 14.1x 12.2x 12.0x 11.6x 11.5x certainty around the U.S. election and vaccination 11.1x 10.0x 9.8x 12.0x 9.7x expectations increased 9.4x 8.6x 8.3x 8.2x 7.5x 7.8x 5.2x 6.7x 5.7x 5.6x ▪ 8.0x 5.9x As the effects of COVID now begin to diminish, debt 5.4x 4.4x 4.1x 3.7x 4.6x 4.3x 3.8x markets have seemingly recovered, signaling that 3.6x lenders have become increasingly comfortable with 4.0x 4.3x 6.9x 6.5x 6.3x 6.0x 5.9x 5.7x 5.7x 5.7x 5.7x 5.6x 5.3x 4.5x 4.4x macroeconomic and company-specific fundamentals 4.3x 0.0x 3.2x − With increased confidence, lenders are currently looking to provide strong leverage for high-quality assets, particularly ones that have proven their Debt/EBITDA Equity/EBITDA EV/EBITDA stability through the recent market downturn Source: PitchBook ▪ The spread on U.S. high-yield debt has returned to pre- Historical US High Yield Debt Effective Yield COVID levels − 4.22% current effective yield compared with a 12.0% 11.4% 11.38% effective yield on March 23, 2020 (peak of the pandemic) 9.0% ▪ We expect increased activity by lenders in 2021 due to: 6.0% 4.2% − Pent-up demand in M&A activity driven by the impact of COVID 3.0% − Limited Partner agreements and investor
  • 2020 Annual Report Products

    2020 Annual Report Products

    Products 2020 Annual Report From the CEO Dear Fellow Shareholders, Perrigo’s transformation to a pure-play Consumer Self-Care Company has come a long way LQMXVWWZRVKRUW\HDUV:HKDYHUHVWRUHGVXVWDLQDEOHWRSOLQHJURZWKGHOLYHUHGRQRXU¿QDQFLDO SURPLVHVUHFRQ¿JXUHGRXUSRUWIROLRRIEXVLQHVVHVXSGDWHGWKH,7LQIUDVWUXFWXUHDQGSURFHVVHV of the Company, expanded capacity, upgraded leadership talent, installed business intelligence capabilities, built a new product pipeline of over $500 million and re-instilled a sense of pride and energy among our 11,000 team members. Making this even more remarkable, is that we kept the WUDQVIRUPDWLRQRQWUDFNLQWKHIDFHRIWKHJOREDO&29,'SDQGHPLF,KRSH\RXDUHDVSURXGRI3HUULJR¶VJOREDOWHDP DV,DPIRUKRZWKH\ZRUNHGWRNHHSHDFKRWKHUVDIHNHSWRXUHVVHQWLDOSURGXFWVÀRZLQJDQGNHSWRXUWUDQVIRUPDWLRQ to a consumer self-care company on track through all of the personal and professional uncertainty that came their way LQ7KH\DUHKHURHV As a result of their efforts, Perrigo delivered strong net sales growth for the second year in a row in 2020 and World-wide Consumer sales reached a new record high. Equally important, the team stabilized adjusted operating income after a few years of decline even as we invested over $50 million in our business and overcame $35 million RIXQSODQQHGKHDGZLQGVGXHSULPDULO\WR&29,'UHODWHGVDIHW\FRVWVDQGEXVLQHVVLPSDFWIURPWKHZHDNFROG FRXJKDQGÀXVHDVRQUHODWHGWR&29,'¶VLPSDFWRQSXEOLFOLIH$OOLQDOOZHKDGDYHU\VWURQJ\HDU Our transformation efforts reached an essential milestone after the year closed when we announced the sale of RXU3UHVFULSWLRQ3KDUPDFHXWLFDOVEXVLQHVVWR$OWDULV&DSLWDO3DUWQHUV//&7KHWUDQVDFWLRQUHLQIRUFHVRXUDELOLW\