Mylan Sign-On Letter
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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 -
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. -
Mylan Signs Agreement with Gilead to Enhance Access to Tenofovir Alafenamide (TAF)- Based HIV Treatments in Developing Countries
December 1, 2014 Mylan Signs Agreement with Gilead to Enhance Access to Tenofovir Alafenamide (TAF)- based HIV Treatments in Developing Countries PITTSBURGH and HYDERABAD, India, Dec. 1, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Laboratories Limited has entered into an agreement with Gilead Sciences, Inc. under which Mylan has licensed the non-exclusive rights to manufacture and distribute Tenofovir Alafenamide (TAF) as both a single agent product and in combination with other drugs. Tenofovir Alafenamide (TAF) is an investigational antiretroviral drug for the treatment of HIV-1 infection. The license being granted to Mylan extends to 112 countries, which together account for more than 30 million people living with HIV, representing 84% of those infected globally.1 Mylan CEO Heather Bresch said, "Mylan's mission is to provide the world's 7 billion people access to high quality medicines and set new standards in health care. By working with partners like Gilead to help ensure access to innovative new products such as Tenofovir Alafenamide (TAF) in the countries hardest hit by this disease, we can help stem the tide of HIV/AIDS around the world." As part of the licensing agreement, on U.S. Food and Drug Administration (FDA) approval, Mylan will receive a technology transfer from Gilead, enabling the company to manufacture low-cost versions of Tenofovir Alafenamide (TAF), if approved as a single agent or in approved combinations containing Tenofovir Alafenamide (TAF) for developing markets. Phase III trials by Gilead Sciences met their primary objective supporting the potential for Tenofovir Alafenamide (TAF) to provide a new treatment option for individuals living with HIV. -
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 -
Combination Medications
Combination Medications WHAT ARE COMBINATION MEDICATIONS? Combination medications are pills, tablets, or injections that contain more than one medication to treat HIV. They are listed in the tables below. Pharmaceutical companies have been working hard to make their medications easier to take. Part of this effort has been to combine more than one medication into a single pill. These combinations are referred to as fixed-dose combinations (FDCs). Combinationantiretroviral therapy (ART), sometimes called highly active antiretroviral therapy (HAART), has revolutionized the management of HIV infection and rendered it a chronic manageable disease. The first FDC to treat HIV wasCombivir , manufactured by ViiV Healthcare. Combivir contains two nucleoside reverse transcriptase inhibitors (NRTIs): lamivudine and zidovudine. This was followed byTrizivir , also manufactured by ViiV Healthcare. Trizivir includes three NRTIs:abacavir , lamivudine, and zidovudine. Both Combivir and Trizivir are no longer widely used in the U.S. due to the frequency and severity of side effects. Be sure that you do not take a combination medication along with any of its components!For example, do not take Truvada (which contains emtricitabine and tenofovir DF) with tenofovir DF (Viread) or emtricitabine (Emtriva). Your healthcare provider will help you decide which HAART regimen is best for you; take your medications exactly as your healthcare provider tells you to. TABLE OF COMBINATION HIV MEDICATIONS Brand name Year Approved Individual Components Also Known As Manufacturer -
Big Pharma Freshens Up
April 09, 2021 Big pharma freshens up Amy Brown Reliance on established drugs lessened for most large drug makers last year, but staleness is creeping in at Merck and Bristol. All successful drug franchises must one day fade – the challenge comes in finding replacements. It is encouraging therefore to see that almost all major developers improved on the sales freshness index last year, versus 2019, with a couple of notable exceptions. This percentage measure is derived from the proportion of a company’s prescription drug sales that come from products more than 10 years old. Scores range widely within the cohort, showing that some groups have much more work to do than others. Take Abbvie, with 74% of 2020’s drug sales derived from drugs at least a decade old, compared with a much fresher Astrazeneca, at 44%. Abbvie is still very reliant on its mega-blockbuster Humira – the autoimmune antibody contributed 44% of the company’s drugs sales last year – and the big pharma group’s freshness score has not shifted from 2019, when Evaluate Vantage last ran these numbers (Sanofi's geriatric pipeline fails to freshen up, January 22, 2020). Astrazeneca was at the other end of the scale last time and its performance improved again in 2020. The previous laggard Sanofi, meanwhile, has the huge success of Dupixent to thank for its big shift towards the fresher end of the group. The French company’s departure from the top of the table leaves Abbvie, Pfizer and Roche as the stalest big pharma groups, and arguably under the most pressure to find new sales sources. -
Merck & Co., Inc
As filed with the Securities and Exchange Commission on February 25, 2021 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D. C. 20549 _________________________________ FORM 10-K (MARK ONE) ☒ Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the Fiscal Year Ended December 31, 2020 OR ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File No. 1-6571 _________________________________ Merck & Co., Inc. 2000 Galloping Hill Road Kenilworth New Jersey 07033 (908) 740-4000 New Jersey 22-1918501 (State or other jurisdiction of incorporation) (I.R.S Employer Identification No.) Securities Registered pursuant to Section 12(b) of the Act: Title of Each Class Trading Symbol(s) Name of Each Exchange on which Registered Common Stock ($0.50 par value) MRK New York Stock Exchange 1.125% Notes due 2021 MRK/21 New York Stock Exchange 0.500% Notes due 2024 MRK 24 New York Stock Exchange 1.875% Notes due 2026 MRK/26 New York Stock Exchange 2.500% Notes due 2034 MRK/34 New York Stock Exchange 1.375% Notes due 2036 MRK 36A New York Stock Exchange Number of shares of Common Stock ($0.50 par value) outstanding as of January 31, 2021: 2,530,315,668. Aggregate market value of Common Stock ($0.50 par value) held by non-affiliates on June 30, 2020 based on closing price on June 30, 2020: $195,461,000,000. Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. -
Fellow Shareholders, Since Perrigo Company
Fellow Shareholders, Since Perrigo Company plc (NYSE and TASE: PRGO) rejected Mylan N.V.’s (NASDAQ: MYL) unsolicited offer, I have spent a great deal of time speaking with our shareholders and sharing our views on why Mylan’s offer substantially undervalues Perrigo. We are confident in our bright prospects and firmly convinced of the standalone value of Perrigo. I have also engaged with you not only about value, but also about the right way to run a company. I have always believed that good corporate governance creates value for shareholders while bad corporate governance can destroy it. Since becoming the CEO of the Perrigo Company, I have had the privilege of working alongside a Board that shares my commitment to shareholder value creation and sound corporate governance. Together, we believe deeply in our responsibility to shareholders, who are Perrigo’s true owners, and in our obligation to build sustainable, long-term value, which informs everything we do. This commitment has rewarded Perrigo shareholders with a total return exceeding 970 percent since 2007. I have watched with increasing distress the contrast in attitude to shareholders and governance principles that Mylan has presented in its pursuit of Perrigo. Our Board has considered Mylan’s offer in good faith and we have been earnest and straightforward in explaining why we think it substantially undervalues Perrigo and creates significant risks. We have also engaged with you to explain how Perrigo’s ‘Base Plus, Plus, Plus’ strategy is poised to continue to create value in the future for our shareholders. In recent weeks, it has become clear to me that Mylan’s pursuit of Perrigo at all costs has further highlighted some very troubling corporate governance values. -
Valeant Pharmaceuticals International, Inc. 2012 Annual Report Valeant Inc
Valeant Pharmaceuticals International, Inc. 2012 Annual Report Valeant Pharmaceuticals International, Inc. 2012 Annual Report Valeant Gathering Momentum Company Overview Valeant Pharmaceuticals International, Inc. (NYSE/TSX:VRX) is a multinational specialty pharmaceutical company that develops and markets prescription and non-prescription pharmaceutical products that make a meaningful difference in patients’ lives. Valeant’s primary focus is principally in the areas of dermatology and neurology. The Company’s growth strategy is to acquire, develop and commercialize new products through strategic partnerships, and build on the company’s strength in dermatology and neurology. Valeant plans to strategically expand its pipeline by adding new compounds or products through product or company acquisitions and will maximize its pipeline through strategic partnering to optimize its research and development assets and strengthen ongoing internal development capabilities. Valeant’s strategic markets are primarily in the United States, Canada, Central and Eastern Europe, Latin America, Australia and South East Asia. Headquartered in Montreal, Quebec, Valeant has approximately 7,000 employees worldwide. FORWARD-LOOKING Statements In addition to current and historical information, this Annual Report contains forward-looking statements, including, without limitation, statements regarding our strategy, expected future revenue, the prospects for approval of product candidates and the timing of regulatory approvals, and the growth and future development of the company, its business units and its products. Words such as “expects,” “anticipates,” “intends,” “plans,” “should,” “could,” “would,” “may,” “will,” “believes,” “estimates,” “potential,” or “continue” or similar language identify forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties. Our actual results may differ materially from those contemplated by the forward-looking statements. -
Proxy Statement 2021
Purpose Blueprint OUR PURPOSE Breakthroughs that change patients’ lives OUR BOLD MOVES 1. Unleash the 2. Deliver 3. Transform our 4. Win the 5. Lead the power of our first-in-class go-to-market digital race conversation people science model in pharma OUR BIG IDEAS 1.1 Create room for 2.1 Source the best 3.1 Improve access 4.1 Digitize drug 5.1 Be known as the meaningful work science in the through new payer discovery and most patient- 1.2 Recognize both world partnerships development centric company leadership and 2.2 Double our 3.2 Address the 4.2 Enhance health 5.2 Drive pro- performance innovation success patient outcomes and innovation/pro- 1.3 Make Pfizer an rate affordability patient experience patient policies amazing 2.3 Bring medicines to challenge 4.3 Make our work 5.3 Focus the narrative workplace for all the world faster 3.3 Transform the way faster and easier on the value of our we engage science patients and physicians OUR VALUES Courage Excellence Equity Joy A Letter from Pfizer’s Chairman & Chief Executive Officer To Our Shareholders: 2020 was a year like none other in Pfizer’s history – defined by bold decisions, even bolder actions and incredible results. With the separation of Upjohn, we created a company that was 20% smaller, but more focused than ever on delivering first-in-class science for the benefit of patients. Through our collaboration with BioNTech, we delivered a breakthrough COVID-19 vaccine in less than a year. And by harnessing the power of a variety of digital capabilities – as well as our own steadfast commitment to patients – we made sure that despite lockdowns and travel restrictions, we continued to reach more than 400 million patients worldwide with our medicines and vaccines. -
1:19-Cv-02226 Document #: 1 Filed: 04/01/19 Page 1 of 74 Pageid #:1
Case: 1:19-cv-02226 Document #: 1 Filed: 04/01/19 Page 1 of 74 PageID #:1 IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF ILLINOIS WELFARE PLAN OF THE INTERNATIONAL UNION OF OPERATING ENGINEERS LOCALS 137, 137A, 137B, 137C, 137R, on behalf of itself Civil Action No.______________ and all others similarly situated, CLASS ACTION Plaintiff, v. JURY TRIAL DEMANDED ABBVIE INC., ABBVIE BIOTECHNOLOGY LTD, and AMGEN INC., Defendants. CLASS ACTION COMPLAINT Case: 1:19-cv-02226 Document #: 1 Filed: 04/01/19 Page 2 of 74 PageID #:2 TABLE OF CONTENTS I. INTRODCUTION ...............................................................................................................1 II. PARTIES .............................................................................................................................3 III. JURISDICTION AND VENUE ..........................................................................................5 IV. THE REGULATORY FRAMEWORK OF BIOLOGICS ..................................................6 A. Cost Concerns Prompt Congress to Enact the Biologics Price Competition and Innovation Act ..............................................................................6 1. New biologic drug approval under the BPCIA ............................................7 2. Biosimilar drug approval under the BPCIA .................................................8 3. Biosimilar entrants’ effect on marketplace ..................................................9 B. Patent Challenges Under the BPCIA .....................................................................11 -
February 2021 EPS Pipeline Report
Pipeline Report February 2021 Pipeline Report February 2021 © 2021 Envolve. All rights reserved. Page 1 This quarterly at-a-glance publication is developed by our Clinical Pharmacy Drug Information team to increase your understanding of the drug pipeline, Table of Contents ensuring you’re equipped with insights to prepare for shifts in pharmacy benefit management. In this issue, you’ll learn more about key themes and notable drugs referenced in the following points. COVID-19 1 > Veklury is currently the only agent that is FDA-approved for the treatment of COVID-19. Three additional therapeutics and two vaccines have been granted Emergency Use Authorization (EUA), and at least three more vaccines are Recent Specialty Drug Approvals1 4 expected to receive an EUA in the relatively near future. > The previous quarter noted the approval of several breakthrough therapies for rare or ultra-rare conditions, which previously had no available FDA-approved Recent Non-Specialty Drug Approvals 9 treatments — Zokinvy for Hutchinson-Gilford progeria syndrome and progeroid laminopathies, Oxlumo for primary hyperoxaluria type 1, and Imcivree for genetically mediated obesity. Upcoming Specialty Products 10 > Other notable approvals include: Lupkynis — the first oral therapy approved for lupus nephritis; Orladeyo — the first oral therapy approved as prophylaxis of hereditary angioedema attacks;Cabenuva – the first long-acting injectable antiretroviral therapy intended as maintenance treatment of HIV; and Breyanzi — Upcoming Non-Specialty Products 18 the