Fidelity® Select Portfolio® Pharmaceuticals Portfolio
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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 -
COVID-19 Treatment and Vaccine Tracker This Document Contains an Aggregation of Publicly Available Information from Validated Sources
COVID-19 Treatment and Vaccine Tracker This document contains an aggregation of publicly available information from validated sources. It is not an endorsement of one approach or treatment over another but simply a list of all treatments and vaccines currently in development. TREATMENTS Current Type of FDA-Approved Clinical Trials for Funding Clinical Trials for Anticipated Next Number Developer/Researcher Stage of Published Results Sources Product - Treatment Indications Other Diseases Sources COVID-19 Steps Timing Development ANTIBODIES PhRMA Begin Phase 1 trials in late Polyclonal hyperimmune Alliance among Takeda, CSL Behring, Wall Street Journal spring. To patients between 1 globulin (H-IG), formerly N/A Biotest AG, Bio Products Laboratory, Pre-clinical Pink Sheet December 2020 and December known at TAK-888 LFB, and Octapharma Press release from the 2021 alliance Biomedical Stat News Advanced MarketWatch Antibodies from mice, Research and Reuters 2 REGN3048-3051, against the N/A Regeneron Pre-clinical Start Phase 1 June 2020 Development Bloomberg News spike protein Authority FierceBiotech (BARDA) FiercePharma Korea Herald Antibodies from recovered 3 N/A Celltrion Pre-clinical Start Phase 1 in July 2020 UPI COVID-19 patients Celltrion press release Super-antibody or antibody 4 cocktail to target potential N/A Celltrion Pre-clinical Celltrion press release mutations of SARS-CoV-2 Antibodies from recovered BioSpace 5 N/A Kamada Pre-clinical COVID-19 patients AbbVie Stat News Antibodies from recovered 6 N/A Vir Biotech/WuXi Biologics/Biogen Pre-clinical Start Phase 1 ~ July 2020 Vir Biotech COVID-19 patients Vir Biotech * Indicates updated or new field This document contains an aggregation of publicly available information from validated sources. -
Companies in Attendance
COMPANIES IN ATTENDANCE Abbott Diabetes Care Archbow Consulting LLC Business One Technologies Abbott Laboratories ARKRAY USA BusinessOneTech AbbVie Armory Hill Advocates, LLC CastiaRX ACADIA Artia Solutions Catalyst Acaria Health Asembia Celgene Accredo Assertio Therapeutics Celltrion Acer Therapeutics AssistRx Center for Creative Leadership Acorda Therapeutics Astellas Pharma US Inc. Cigna Actelion AstraZeneca Cigna Specialty Pharmacy AdhereTech Athenex Oncology Circassia Advantage Point Solutions Avanir Coeus Consulting Group Aerie Pharmaceuticals Avella Coherus Biosciences AGIOS AveXis Collaborative Associates LLC Aimmune Theraputics Bank of America Collegium Akcea Therapeutics Bausch Health Corsica Life Sciences Akebia Therapeutics Bayer U.S. CoverMyMeds Alder BioPharmaceuticals Becton Dickinson Creehan & Company, Inc., an Inovalon Company Alexion Biofrontera CSL Behring Alkermes Biogen Curant Health Allergan Biohaven CVS Health Almirall BioMarin D2 Consulting Alnylam BioMatrix Specialty Pharmacy Daiichi Sankyo Amarin BioPlus Specialty Pharmacy DBV Technologies Amber Pharmacy Bioventus Deloitte Consulting LLP AmerisourceBergen Blue Cross Blue Shield Association Dendreon Amgen Blue Fin Group Dermira Amicus Therapeutics bluebird bio Dexcom Amneal Boehringer Ingelheim Diplomat Pharmacy Anthem Boston Biomedical Dova Applied Policy Bowler and Company Decision Resources Group Aquestive Therapeutics Braeburn Eisai Arbor Pharmaceuticals Bristol-Myers Squibb 1 electroCore Indivior Merz Pharmaceuticals EMD Serono Inside Rx Milliman Encore Dermatology, -
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. -
Case 5:19-Cv-01087-OLG Document 55 Filed 05/07/20 Page 1 of 11
Case 5:19-cv-01087-OLG Document 55 Filed 05/07/20 Page 1 of 11 UNITED STATES DISTRICT COURT WESTERN DISTRICT OF TEXAS SAN ANTONIO DIVISION RAMON D. JOHNSON, II, § Plaintiffs, § § v. § § Civil Action No. 5:19-cv-01087-OLG NOVARTIS PHARMACEUTICALS § CORPORATION; TARO § PHARMACEUTICALS USA, INC.; § BAUSCH HEALTH US, LLC; SUN § PHARMACEUTICAL INDUSTRIES § LTD.; and TORRENT PHARMA, INC., § Defendants. § ORDER On this day, the Court considered the status of the above-captioned case. Currently pending before the Court are Defendants Sun Pharmaceutical Industries and Tara Pharmaceuticals USA’s Motion to Dismiss (docket no. 8); Defendant Novartis Pharmaceuticals Corporation’s Motion to Dismiss (docket no. 9); Defendant Torrent Pharma, Inc.’s Motion to Dismiss (docket no. 12); and Defendant Bausch Health US, LLC’s Motion to Dismiss (docket no. 23). Also pending are Plaintiff’s Motion for Leave to File a Combined Rebuttal to Defendants’ Replies in Support of their Motions to Dismiss (docket no. 44) and Plaintiff’s Motion for Leave to File a First Amended Complaint for a Civil Case and To Edit the Style of the Case (docket no. 47). Having considered each of these Motions and the record, the Court finds that Defendants’ Motions to Dismiss should be GRANTED. BACKGROUND On September 10, 2019, Plaintiff Ramon D. Johnson II (“Plaintiff”) initiated this lawsuit alleging that he suffered personal injuries resulting from his use of two drugs: Minocycline and Carbamazepine. See docket no. 1. Specifically, Plaintiff alleges that he was prescribed 1 Case 5:19-cv-01087-OLG Document 55 Filed 05/07/20 Page 2 of 11 Minocycline in April 2013 for an unrelated condition. -
FDA Listing of Authorized Generics As of July 1, 2021
FDA Listing of Authorized Generics as of July 1, 2021 Note: This list of authorized generic drugs (AGs) was created from a manual review of FDA’s database of annual reports submitted to the FDA since January 1, 1999 by sponsors of new drug applications (NDAs). Because the annual reports seldom indicate the date an AG initially entered the market, the column headed “Date Authorized Generic Entered Market” reflects the period covered by the annual report in which the AG was first reported. Subsequent marketing dates by the same firm or other firms are not included in this listing. As noted, in many cases FDA does not have information on whether the AG is still marketed and, if not still marketed, the date marketing ceased. Although attempts have been made to ensure that this list is as accurate as possible, given the volume of d ata reviewed and the possibility of database limitations or errors, users of this list are cautioned to independently verify the information on the list. We welcome comments on and suggested changes (e.g., additions and deletions) to the list, but the list may include only information that is included in an annual report. Please send suggested changes to the list, along with any supporting documentation to: [email protected] A B C D E F G H I J K L M N O P Q R S T U V X Y Z NDA Applicant Date Authorized Generic Proprietary Name Dosage Form Strength Name Entered the Market 1 ACANYA Gel 1.2% / 2.5% Bausch Health 07/2018 Americas, Inc. -
12/31/20 at 0.06% Due 01/04/21 $ 969,572 969,572 Barclays Capital, Inc
Biotechnology Fund SCHEDULE OF INVESTMENTS (Unaudited) December 31, 2020 Shares Value COMMON STOCKS† - 99.6% Biotechnology - 72.9% Amgen, Inc. 46,124 $ 10,604,830 Gilead Sciences, Inc. 137,327 8,000,671 Vertex Pharmaceuticals, Inc.* 30,030 7,097,290 Illumina, Inc.* 18,293 6,768,410 Regeneron Pharmaceuticals, Inc.* 13,496 6,520,053 Biogen, Inc.* 22,700 5,558,322 Moderna, Inc.* 49,814 5,204,069 Corteva, Inc. 125,161 4,846,234 Alexion Pharmaceuticals, Inc.* 30,030 4,691,887 Seagen, Inc.* 26,529 4,646,289 Exact Sciences Corp.* 31,204 4,134,218 Incyte Corp.* 44,634 3,882,265 Bio-Rad Laboratories, Inc. — Class A* 6,450 3,759,963 BioMarin Pharmaceutical, Inc.* 38,909 3,411,930 Alnylam Pharmaceuticals, Inc.* 25,838 3,358,165 Guardant Health, Inc.* 25,656 3,306,545 Mirati Therapeutics, Inc.* 13,253 2,910,889 Ionis Pharmaceuticals, Inc.* 48,279 2,729,695 ACADIA Pharmaceuticals, Inc.* 49,103 2,625,046 CRISPR Therapeutics AG* 16,740 2,563,061 BeiGene Ltd. ADR* 9,710 2,508,967 Acceleron Pharma, Inc.* 18,632 2,383,778 Iovance Biotherapeutics, Inc.* 50,194 2,329,002 Arrowhead Pharmaceuticals, Inc.* 30,137 2,312,412 United Therapeutics Corp.* 15,148 2,299,315 BioNTech SE ADR*,1 27,800 2,266,256 Ultragenyx Pharmaceutical, Inc.* 16,339 2,261,808 Twist Bioscience Corp.* 15,850 2,239,446 Exelixis, Inc.* 111,104 2,229,857 Novavax, Inc.*,1 19,860 2,214,589 Amicus Therapeutics, Inc.* 95,070 2,195,166 Halozyme Therapeutics, Inc.* 50,560 2,159,418 Blueprint Medicines Corp.* 18,770 2,105,056 Fate Therapeutics, Inc.* 23,040 2,095,027 Sage Therapeutics, Inc.* 23,286 2,014,472 Biohaven Pharmaceutical Holding Company Ltd.* 22,920 1,964,473 Arena Pharmaceuticals, Inc.* 25,260 1,940,726 ChemoCentryx, Inc.* 30,270 1,874,318 PTC Therapeutics, Inc.* 29,928 1,826,506 Emergent BioSolutions, Inc.* 20,360 1,824,256 Bluebird Bio, Inc.* 36,415 1,575,677 Global Blood Therapeutics, Inc.* 34,845 1,509,137 Inovio Pharmaceuticals, Inc.*,1 125,840 1,113,684 Total Biotechnology 143,863,178 Pharmaceuticals - 17.5% AbbVie, Inc. -
Bausch Health Update – 3Q19 Seventh Consecutive Quarter of Total Company Organic Revenue Growth1,2
3Q 19 Financial Results Forward-Looking Statements This presentation contains forward-looking information and statements, within the meaning of Commission and the Canadian Securities Administrators, which risks and uncertainties are applicable securities laws (collectively, “forward-looking statements”), including, but not limited incorporated herein by reference. In addition, certain material factors and assumptions have to, statements regarding Bausch Health's future prospects and performance (including the been applied in making these forward-looking statements, including, without limitation, Company’s 2019 full-year guidance and targeted three-year CAGR1 of revenue growth and assumptions regarding our 2019 full-year guidance with respect to currency impact, adjusted Adjusted EBITDA (non-GAAP) growth), planned dermatology growth, anticipated growth of SG&A expense (non-GAAP) and the Company’s ability to continue to manage such expense revenues in Salix business unit, anticipated revenue from TRULANCE®, the expected impact in the manner anticipated, the anticipated timing and extent of the Company’s R&D expense, on long-term growth of new product approvals, the anticipated submission, approval and the expected timing and impact of loss of exclusivity for certain of our products, expected base launch dates for certain of our pipeline products and R&D programs, the anticipated timing of performance, expectations regarding our newly acquired TRULANCE® product and commencement of studies or other development work of our pipeline products and R&D expectations regarding gross margin, assumptions respecting our targeted three-year CAGR programs, the anticipated timing of the loss of exclusivity of certain of our products and the of revenue growth and Adjusted EBITDA (non-GAAP) growth including, without limitation, expected impact of such loss of exclusivity on our financial condition, expected reported expectations on constant currency and mid-point of Feb. -
Horizon Pharma Plc 2018 Irish Statutory Accounts
Horizon Pharma plc 2018 Irish Statutory Accounts (“Irish Annual Report”) CONTENTS Page DIRECTORS AND OTHER INFORMATION 2 DIRECTORS' REPORT 3 – 69 INDEPENDENT AUDITOR’S REPORT 70 – 75 CONSOLIDATED PROFIT AND LOSS ACCOUNT 76 CONSOLIDATED STATEMENT OF COMPREHENSIVE LOSS 77 CONSOLIDATED BALANCE SHEET 78 – 79 CONSOLIDATED STATEMENT OF SHAREHOLDERS’ EQUITY 80 CONSOLIDATED STATEMENT OF CASH FLOWS 81 – 82 NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS 83 – 142 PARENT COMPANY FINANCIAL STATEMENTS 143 – 153 DIRECTORS AND OTHER INFORMATION Board of Directors at December 31, 2018 Timothy P. Walbert Michael Grey William F. Daniel Jeff Himawan, Ph.D. Ronald Pauli Gino Santini James Shannon, M.D. H. Thomas Watkins Pascale Witz Secretary and Registered Office Anne-Marie Dempsey Connaught House 1st Floor 1 Burlington Road Dublin 4 D04 C5Y6 Ireland Registered Number: 507678 Auditor PricewaterhouseCoopers Chartered Accountants and Statutory Audit Firm One Spencer Dock North Wall Quay Dublin 1 D01 X9R7 Ireland Solicitor Matheson 70 Sir John Rogerson’s Quay Grand Canal Dock Dublin 2 D02 R296 Ireland 2 DIRECTORS’ REPORT The directors present their report and the audited financial statements of the Company (as defined below) for the financial year ended December 31, 2018. Basis of Presentation The Company is a public limited company formed under the laws of Ireland. The Company operates through a number of international and U.S. subsidiaries with principal business purposes to either perform research and development or manufacturing operations, serve as distributors -
Biopharma Leaders Join Trump and Thunberg in Davos
No. 3989 January 31, 2020 again a key theme at Davos, and many biopharma executives are joining the con- versation this year. These include Werner Baumann, CEO of Bayer, who spoke on a panel on 21 Janu- ary about ‘When Humankind Overrides Evolution,’ focusing on gene-editing tech- nologies for use in agriculture, food and medicine. Meanwhile Takeda CEO Chris- tophe Weber joins a discussion on shap- ing the future of health and healthcare systems on 22 January. Speaking on the gene-editing panel, Baumann said there was “less and less trust in society for the advances of tech- nology,” adding that “the only way to get beyond it is that we do a better job in terms of explaining what we are doing.” Bayer is working with CRISPR Thera- peutics on CRISPR/Cas9 gene-editing in hemophilia, ophthalmology and autoim- Biopharma Leaders Join Trump mune diseases, but also has a major stake in genetically modified seeds via its Mon- And Thunberg In Davos santo division. He called for absolute transparency ANDREW MCCONAGHIE [email protected] from corporations and governments on gene-editing technology, but also decried fter focusing on the year ahead tive to plant 1 trillion trees, an effort aimed the previous “insane dominance” that anti- in biopharma business at the J.P. at soaking up rising levels of carbon diox- GM crop campaigners have been allowed AMorgan conference in San Fran- ide in the atmosphere. to wield. cisco last week, the sector’s attention has 17-year-old environmental campaigner Others taking part include Stéphane switched to the World Economic Forum in Greta Thunberg made her own address to Bancel, Moderna Therapeutics’ chief exec- Davos, Switzerland from 21-24 January. -
Rebateable Manufacturers
Rebateable Labelers – July 2021 Manufacturers are responsible for updating their eligible drugs and pricing with CMS. Montana Healthcare Programs will not pay for an NDC not updated with CMS. Note: Some manufacturers on this list may have some NDCs that are covered and others that are not. Manufacturer ID Manufacturer Name 00002 ELI LILLY AND COMPANY 00003 E.R. SQUIBB & SONS, LLC. 00004 HOFFMANN-LA ROCHE 00006 MERCK & CO., INC. 00007 GLAXOSMITHKLINE 00008 WYETH PHARMACEUTICALS LLC, 00009 PHARMACIA AND UPJOHN COMPANY LLC 00013 PFIZER LABORATORIES DIV PFIZER INC 00015 MEAD JOHNSON AND COMPANY 00023 ALLERGAN INC 00024 SANOFI-AVENTIS, US LLC 00025 PFIZER LABORATORIES DIV PFIZER INC 00026 BAYER HEALTHCARE LLC 00032 ABBVIE INC. 00037 MEDA PHARMACEUTICALS, INC. 00039 SANOFI-AVENTIS, US LLC 00046 WYETH PHARMACEUTICALS INC. 00049 ROERIG 00051 ABBVIE INC 00052 ORGANON USA INC. 00053 CSL BEHRING L.L.C. 00054 HIKMA PHARMACEUTICAL USA, INC. 00056 BRISTOL-MYERS SQUIBB PHARMA CO. 00065 ALCON LABORATORIES, INC. 00068 AVENTIS PHARMACEUTICALS 00069 PFIZER LABORATORIES DIV PFIZER INC 00071 PARKE-DAVIS DIV OF PFIZER 00074 ABBVIE INC 00075 AVENTIS PHARMACEUTICALS, INC. 00078 NOVARTIS 00085 SCHERING CORPORATION 00087 BRISTOL-MYERS SQUIBB COMPANY 00088 AVENTIS PHARMACEUTICALS 00093 TEVA PHARMACEUTICALS USA, INC. 00095 BAUSCH HEALTH US, LLC Page 1 of 19 Manufacturer ID Manufacturer Name 00096 PERSON & COVEY, INC. 00113 L. PERRIGO COMPANY 00115 IMPAX GENERICS 00116 XTTRIUM LABORATORIES, INC. 00121 PHARMACEUTICAL ASSOCIATES, INC. 00131 UCB, INC. 00132 C B FLEET COMPANY INC 00143 HIKMA PHARMACEUTICAL USA, INC. 00145 STIEFEL LABORATORIES, INC, 00168 E FOUGERA AND CO. 00169 NOVO NORDISK, INC. 00172 TEVA PHARMACEUTICALS USA, INC 00173 GLAXOSMITHKLINE 00178 MISSION PHARMACAL COMPANY 00185 EON LABS, INC. -
SCHEDULE of INVESTMENTS (Unaudited) HEALTH CARE FUND
SCHEDULE OF INVESTMENTS (Unaudited) June 30, 2021 HEALTH CARE FUND SHARES VALUE SHARES VALUE COMMON STOCKS† - 99.7% Jazz Pharmaceuticals plc* 701 $ 124,526 GlaxoSmithKline plc ADR 2,917 116,155 HEALTHCARE-PRODUCTS - 30.2% Novartis AG ADR 1,250 114,050 Abbott Laboratories 3,480 $ 403,436 Viatris, Inc. 7,920 113,177 Thermo Fisher Scientific, Inc. 784 395,504 Cardinal Health, Inc. 1,962 112,011 Danaher Corp. 1,454 390,195 Elanco Animal Health, Inc.* 3,174 110,106 Medtronic plc 2,655 329,565 Perrigo Company plc 2,294 105,180 Intuitive Surgical, Inc.* 319 293,365 Teva Pharmaceutical Industries Ltd. ADR* 10,447 103,425 Stryker Corp. 1,051 272,976 PRA Health Sciences, Inc.* 540 89,213 Edwards Lifesciences Corp.* 2,164 224,125 Bausch Health Companies, Inc.* 3,026 88,722 Boston Scientific Corp.* 4,995 213,586 Neurocrine Biosciences, Inc.* 855 83,209 IDEXX Laboratories, Inc.* 328 207,148 Organon & Co.* 2,475 74,893 Align Technology, Inc.* 313 191,243 Sarepta Therapeutics, Inc.* 871 67,712 Baxter International, Inc. 2,171 174,766 ResMed, Inc. 679 167,387 Total Pharmaceuticals 5,624,909 Zimmer Biomet Holdings, Inc. 994 159,855 BIOTECHNOLOGY - 20.5% West Pharmaceutical Services, Inc. 399 143,281 Amgen, Inc. 1,348 328,575 10X Genomics, Inc. — Class A* 649 127,087 Moderna, Inc.* 1,229 288,790 STERIS plc 616 127,081 Gilead Sciences, Inc. 3,768 259,464 Avantor, Inc.* 3,564 126,558 Illumina, Inc.* 493 233,293 Novocure Ltd.* 549 121,779 Regeneron Pharmaceuticals, Inc.* 389 217,272 Hologic, Inc.* 1,761 117,494 Vertex Pharmaceuticals, Inc.* 1,023 206,268 PerkinElmer, Inc.