Annual Report 2008
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Otonomy Inc. 2021 Proxy Statement
OTONOMY, INC. Dear Stockholder: I am pleased to invite you to attend the 2021 Annual Meeting of Stockholders (the “Annual Meeting”) of Otonomy, Inc. (“Otonomy”), which will be held on June 22, 2021 at 8:00 a.m. Pacific Time. The Annual Meeting will be conducted virtually via live webcast. You will be able to attend the Annual Meeting by visiting www.virtualshareholdermeeting.com/OTIC2021, where you will be able to listen to the meeting live, submit questions and vote online by entering the control number located on your proxy card. The attached Notice of Annual Meeting of Stockholders and proxy statement contain details of the business to be conducted at the Annual Meeting. Whether or not you attend the Annual Meeting, it is important that your shares be represented and voted at the meeting. Therefore, I urge you to promptly vote and submit your proxy via the Internet, by phone, or by signing, dating and returning the enclosed proxy card in the enclosed envelope. If you decide to attend the Annual Meeting, you will be able to change your vote or revoke your proxy, even if you have previously submitted your proxy. On behalf of Otonomy, I would like to thank you for your continued support. Sincerely, David A. Weber, Ph.D. President and Chief Executive Officer OTONOMY, INC. 4796 Executive Drive San Diego, California 92121 NOTICE OF ANNUAL MEETING OF STOCKHOLDERS Time and Date June 22, 2021 at 8:00 a.m. Pacific Time The Annual Meeting will be a completely virtual meeting of stockholders, to be conducted via live webcast. -
Chief Executive Officer Graham Baker
OVERVIEW OUR BUSINESS OPERATIONAL FINANCIAL RISK GOVERNANCE ACCOUNTS 48 & MARKETPLACE REVIEW REVIEW OUR BOARD OF DIRECTORS ROBERTO QUARTA (67) OLIVIER BOHUON (58) GRAHAM BAKER (48) CHAIRMAN CHIEF EXECUTIVE OFFICER CHIEF FINANCIAL OFFICER Joined the Board in December 2013 and Joined the Board and was appointed Chief -RLQLQJWKH%RDUGDV&KLHI)LQDQFLDO2I²FHULQ appointed Chairman following election by ([HFXWLYH2I²FHULQ$SULO+HUHVLJQHGDV March 2017. shareholders at the April 2014 Annual General a Member of the Nomination & Governance Meeting. He was also appointed Chairman of &RPPLWWHHRQ)HEUXDU\ CAREER AND EXPERIENCE the Nomination & Governance Committee and Graham holds an MA degree in Economics from a Member of the Remuneration Committee on CAREER AND EXPERIENCE Cambridge University and qualified as a Chartered that day. Olivier holds a doctorate in Pharmacy from the Accountant and Chartered Tax Advisor with Arthur University of Paris and an MBA from HEC, Paris. Andersen. In 1995, he joined AstraZeneca PLC where CAREER AND EXPERIENCE He started his career in Morocco with Roussel Uclaf he worked for 20 years, holding multiple senior roles, Roberto is a graduate and a former Trustee of the S.A. and then, with the same company, held a number including Vice President, Finance, International (2013- College of the Holy Cross, Worcester (MA), US. of positions in the Middle East with increasing levels of 2015) with responsibility for all emerging markets, He started his career as a manager trainee at David responsibility. He joined Abbott in Chicago as head of Vice President, Global Financial Services (2011-2013) Gessner Ltd, before moving on to Worcester Controls their anti-infective franchise with Abbott International and Vice President Finance & Chief Financial Officer, Corporation and then BTR plc, where he was a before becoming Pharmaceutical General Manager North America (2008-10). -
Analyst Report
ASTRAZENECA PLC AZN LN Sector: Healthcare Industry: EUROPEAN EQUITY Pharmaceuticals RESEARCH I SHORT POSITION MEMO Market Unattractive position with a limited scope REDUCE Capitalization: €58,920.65 m With negative sales growth of 6 %, a loss of 23% in earnings per share (01/28/2014) compared to 2012 and a last quarter negative operating and net income, AstraZeneca is facing a challenge to recover a decent sales and profitability level in the Pharmaceutical industry. Country: GB FY 2013 ISIN: GB0009895292 In Millions Est FY 2012 FY 2011 FY 2010 FY 2009 Index: STOXX 600 12/31/2013 12/31/2012 12/31/2011 12/31/2010 12/31/2009 Market: London Stock Shares issued 1,257.00 1,261.00 1,361.00 1,438.00 1,448.00 Dividend yield (%) Exchange 2.26 1.99 1.77 1.48 Price 43.07 36.94 36.25 34.73 32.78 Revenue 20,462.28 21,768.38 24,151.51 25,129.22 23,588.60 oji Growth %, YoY -6.00 -9.87 -3.89 6.53 Source : Bloomberg # of employees: 53,500 CEO: Pascal Soriot AZN AVG P/E 17.38 21.32 P/S 3.05 3.56 P/EBITDA 8.04 11.11 P/B 3.45 5.72 2Y RV GR -2% OPE CF -5% ANALYST: Valentin ROUSSEL [email protected] The stock is outperforming the Legal & General Global Health and Pharmaceuticals Index since December (+24.6% in one year,Source +17.8% : Bloomberg in 5 years). The price should reflect a reaction to pipeline new introductions and investors looking beyond the patent cliff. -
Affymetrix and the "DNA Chip" Revolution
taken pride in placing in the top 10 among the The Evolution of Astra best companies to work for in a number of ∗ magazine surveys, from Fortune to Working Merck Inc. in 1998 Mother. Merck & Co. sales grew from $9.6 billion in 1992 to $23 billion by the end of "We plan to revolutionize the pharmaceutical industry by 19972, topping the world drug sales league in being the best at linking patients and products.” Wayne Yetter, President of Astra Merck Inc. both years. In fact, Merck has seen its global market share jump one-third in the 1992-1998 period to edge Glaxo Wellcome in 1997 with a Section I. Background 3 4.6% world market share. In contrast to the In 1982, Merck & Co. and Astra AB signed an strategy of other pharmaceutical companies such agreement by which products resulting from as Glaxo, this growth was largely fueled by Astra’s research pipeline would be taken through internal R&D efforts as opposed to mergers and clinical trials and registration, to be ultimately acquisitions. marketed and sold by Merck in the United States. The initial terms of the contract specified Another major strategic move made to enhance that Astra’s products would be transferred to its competitive position was the acquisition of Merck’s development and marketing Medco Containment Services Inc. in 1993 organizations, with Astra receiving royalties on (renamed Merck-Medco Managed Care). the sales of the Astra drugs.1 Merck-Medco provides pharmaceutical benefit services in the United States to control The initial cooperation and relationship between prescription drug benefits cost. -
Pharmaceuticals, Medical Devices and Biologics Regulatory and Policy Bulletin
Antitrust Connection Spring 2009 To: Our Clients and Friends August 27, 2010 Pharmaceuticals, Medical Devices and Biologics Regulatory and Policy Bulletin Top News During China Visit, FDA Commissioner’s Focus Not on Heparin Investigation FDA Commissioner Margaret Hamburg’s recent trip to China focused primarily on avenues of collaboration and cooperation between the FDA and Chinese regulators rather than on the current investigation into the contamination of heparin, which has caused some to express concern that US legislators may perceive the two bodies as not trying to work effectively to determine the cause of the contamination. FDA officials have indicated that the issue was discussed, but it was not focused on during the meetings. Industry Expresses Concern Over New Drug User Fees The drug industry is expressing concern over the FDA’s recent increase in prescription drug user fee rates, saying that the increase of approximately 10 percent is not appropriate given the backlog and failure to meet other review deadlines. Industry has indicated that it would like more accountability and adherence to performance goals if will be paying such increased fees. As the FDA discusses drug user fees and other programs as part of the Prescription Drug User Fee Act legislative proposal, some consumer, safety, and patient groups are voicing their concern that the agency is not including them in its discussions of the Act. Official, Panel Members Criticize Glaxo’s Report on Avandia Committee Meeting An article in the New York Times indicates that a government official and some members of the FDA advisory panel that recently reviewed Avandia are critical of Glaxo’s letter to doctors participating in the TIDE trial, intended to compare the risks of Avandia with those of competing drug Actos. -
Astrazeneca Plc
6/15/2020 AstraZeneca - Wikipedia AstraZeneca AstraZeneca plc[3] is a British-Swedish multinational pharmaceutical and biopharmaceutical company with its global AstraZeneca plc headquarters in Cambridge, England.[4] Its R&D is concentrated in Cambridge, Gaithersburg, Maryland, and Mölndal in Sweden.[5] AstraZeneca has a portfolio of products for major disease areas including cancer, cardiovascular, gastrointestinal, infection, Type Public limited neuroscience, respiratory and inflammation.[6] company Traded as LSE: AZN (https:// The company was founded in 1999 through the merger of the www.londonstocke [7][8] Swedish Astra AB and the British Zeneca Group (itself formed xchange.com/exch by the demerger of the pharmaceutical operations of Imperial ange/searchengin Chemical Industries in 1993). Since the merger it has been among e/search.html?lang the world's largest pharmaceutical companies and has made =en&x=0&y=0&q= numerous corporate acquisitions, including Cambridge Antibody AZN) Technology (in 2006), MedImmune (in 2007), Spirogen (in 2013) NYSE: AZN (http and Definiens (by MedImmune in 2014). s://www.nyse.com/ quote/XNYS:AZN) AstraZeneca has a primary listing on the London Stock Exchange Nasdaq and is a constituent of the FTSE 100 Index. It has secondary listings Stockholm: AZN (ht on the New York Stock Exchange and the OMX exchange. tp://www.nasdaqom xnordic.com/aktier/ microsite?language Contents Id=1&Instrument=S SE3524) History FTSE 100 2000–06 Component 2007–12: The patent cliff and subsequent acquisitions ISIN GB0009895292 2013 -
How to Sustain Healthcare Transformations
Voices on transformation A marathon, not a sprint: How to sustain healthcare transformations Voices on transformation is written by experts and practitioners in McKinsey & Company’s Pharmaceuticals and Medical Products Practice. To send comments or request copies of this publication, please email us at [email protected] Editors: Gayane Gyurjyan, Ioana Parsons, Shail Thaker, Jill Willder, Carla Zwaanstra Artwork and design: Afitha de Rijk-Voeten Portrait illustrations: Allan Burch Special thanks to: Lucia Darino, Martin Dewhurst, Claudio Feser, Vincent Forlenza, Jane Griffiths, Judith Hazlewood, Nadine Mansour, Angelika Reich, Pascal Soriot, David Speiser, Kirsten Westhues, André Wyss Copyright © 2016 McKinsey & Company. All rights reserved. This publication is not intended to be used as the basis for trading in the shares of any company or for undertaking any other complex or significant financial transaction without consulting appropriate professional advisers. No part of this publication may be copied or redistributed in any form without the prior written consent of McKinsey & Company. 2 PMP Voices on transformation <Chaper title> Contents Introduction 4 Cracking the code: How successful pharma leaders 7 manage transformations A health check for pharma: Overcoming change fatigue 15 in the pharmaceutical industry Putting science at the heart of renewed purpose 26 An interview with Pascal Soriot, AstraZeneca Transforming a medical devices company into a solutions provider 34 An interview with Vincent Forlenza, Becton Dickinson Refocusing the business around patient outcomes 42 An interview with Jane Griffiths, Janssen EMEA NBS: Creating value across Novartis 48 An interview with André Wyss, Novartis Voices on digital: How pharma can win in a digital world 57 About the authors 66 3 Introduction Over the past decade, the pharmaceutical industry has been struggling to keep up with rapid and dramatic changes in the external environment. -
1999 Annual Report and Form 20-F CONTENTS
1999 Annual Report and Form 20-F CONTENTS Key Achievements in 1999 1 Financial Highlights 2 Shareholder Highlights 5 Chairman’s Statement 6 Chief Executive’s Review 7 Operational Review 8 Safety, Health and Environment 32 In April 1999, Astra AB and Zeneca Group PLC People and Community 34 merged to form AstraZeneca, one of the world’s Financial Review 35 leading pharmaceutical and agrochemical Board of Directors and Officers companies, which provides innovative, effective of the Company 48 products to improve health, nutrition and quality Directors’ Report 49 of life worldwide. The company is research and Financial Statements 55 technology intensive, with extensive international Financial statements and notes development and marketing skills. Its healthcare relating to the financial statements 55 business is strategically focused on seven major Principal subsidiaries, joint ventures therapeutic areas: gastrointestinal, oncology, pain and associates 118 control and anaesthesia, cardiovascular, central Additional information for US investors 120 nervous system, respiratory and infection. Zeneca Group Financial Record 129 Agrochemicals provides crop protection products Shareholder Information 131 designed to improve crop yields and food quality. Exchange rates 138 Definitions 139 Glossary of Terms 140 Cross Reference to Form 20-F IBC Cautionary statement regarding forward-looking statements In order to utilise the ‘Safe Harbor’ provisions of the United States Private Securities Litigation Reform Act of 1995, AstraZeneca is providing the following cautionary statement. This Annual Report and Form 20-F 1999 contains forward-looking statements with respect to the financial condition, results of operations and businesses of AstraZeneca. By their nature, forward-looking statements and forecasts involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. -
Astrazeneca Annual Report 2006
AND FORM 20-F ANNUAL INFORMATION REPORT 2006 CONTENTS 2006 IN BRIEF 1 FINANCIAL STATEMENTS 19. Reserves 120 CHAIRMAN’S STATEMENT 2 Preparation of the Financial Statements 20. Minority interests 121 CHIEF EXECUTIVE OFFICER’S REVIEW 3 and Directors’ Responsibilities 96 21. Dividends to shareholders 121 FINANCIAL HIGHLIGHTS 6 Directors’ Responsibilities for, and Report 22. Acquisitions of on, Internal Control over Financial DIRECTORS’ REPORT business operations 121 Reporting 96 Business review 8 23. Disposal of business operations 123 Auditors’ Reports on the Financial 24. Post-retirement benefi ts 123 > Business environment 9 Statements and on Internal Control over > Strategy 11 Financial Reporting (Sarbanes-Oxley Act 25. Employee costs and share option plans for employees 128 > Our resources, skills Section 404) 97 and capabilities 12 Independent Auditors’ Report to the 26. Commitments and contingent liabilities 133 > Measuring performance 15 Members of AstraZeneca PLC (Group) 97 27. Leases 146 > Therapy area review Consolidated Income Statement 98 28. Statutory and other information 146 – Cardiovascular medicines 16 Consolidated Statement of Recognised Income and Expense 98 29. Share capital of parent – Gastrointestinal medicines 20 Consolidated Balance Sheet 99 company 147 – Neuroscience medicines 23 Consolidated Cash Flow Statement 100 Principal Subsidiaries 148 – Oncology medicines 26 Accounting Policies (Group) 101 Additional Information for US Investors 149 – Respiratory and Independent Auditors’ Infl ammation medicines 29 Notes to the Financial Statements (Group) Report to the Members of – Infection medicines 32 AstraZeneca PLC (Company) 157 1. Operating profi t 104 > Geographic review 33 Company Balance Sheet 158 2. Profi t on sale of interest > Research and development 37 in joint venture 104 Accounting Policies (Company) 159 > Development pipeline table 40 3. -
204200Orig1s000 204200Orig2s000
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 204200Orig1s000 204200Orig2s000 MEDICAL REVIEW(S) CLINICAL REVIEW Application Type NDA Application Number(s) 204-200 and 204-640 Priority or Standard Standard Submit Date(s) March 7, 2012 Received Date(s) March 7, 2012 PDUFA Goal Date January 7, 2013 Division / Office DPARP/OND Reviewer Name(s) Peter Starke, MD Review Completion Date October 29, 2012 Established Name Epinephrine injection, USP, 1mg/mL (Proposed) Trade Name Adrenalin® Therapeutic Class Catecholamine Applicant JHP Pharmaceuticals, LLC Formulation(s) Solution for injection Proposed Dosing Hypersensitivity reactions: IM or SC Regimen injection(b) (4) [Ophthalmic use: Topical irrigation or intraocular bolus injection] Proposed Indication(s) Hypersensitivity reactions: severe acute anaphylactic reactions, (b) (4) [Ophthalmic use: induction and maintenance of mydriasis during cataract surgery] Intended Population(s) Hypersensitivity reactions: No age restrictions [Ophthalmic use: No age restrictions] Reference ID: 3209828 Clinical Review ● Peter Starke, MD NDA 204-200 ● Adrenalin® (epinephrine) MEDICAL OFFICER REVIEW Division of Pulmonary, Allergy and Rheumatology Products (DPARP) SUBMISSIONS REVIEWED IN THIS DOCUMENT Document Date CDER Stamp Date Submission Comments March 7, 2012 March 7, 2012 SD-1, eCTD-0000 New NDA submission April 9, 2012 April 9, 2012 SD-2, eCTD-0001 PREA waiver request – Anaphylaxis April 9, 2012 April 9, 2012 SD-3, eCTD-0002 PREA waiver request – Mydriasis April 18, 2012 April 18, 2012 SD-4, eCTD-0003 Request for proprietary name review Sept 5, 2012 Sept 6, 2012 SD-22, eCTD-0021 Draft Ophthalmic Labeling Oct 22, 2012 Oct 22, 2012 SD-27, eCDT-0026 Certification that EpiPen is the reference for the 505(b)(2) application RECOMMENDED REGULATORY ACTION NDA/SUPPLEMENTS: X APPROVAL COMPLETE RESPONSE OTHER ACTION: 2 Reference ID: 3209828 Clinical Review ● Peter Starke, MD NDA 204-200 ● Adrenalin® (epinephrine) Table of Contents 1 RECOMMENDATIONS/RISK BENEFIT ASSESSMENT ........................................ -
Zusammenfassung Dit-Votum Vom 01.01.2005 Bis 31.12.2005
Zusammenfassung dit-Votum vom 01.01.2005 bis 31.12.2005 ISIN Gesellschaft Antrag- Mgmt- dit- Datum-HV Tagesordnungspunkt steller Empfehlung Votum Art-HV ES0105200416 Abengoa S.A. 25.06.2005 AGM 1 Genehmigung von Einzel- und Konzernjahresabschluss für das Geschäftsjahr 2004; Mgmt für für Genehmigung der Entlastung der Directors 2 Genehmigung der Gewinnzuweisung Mgmt für für 3 Wahl der Abschlussprüfer für Unternehmen und konsolidierten Konzern Mgmt für für 4 Änderung von Artikel 39 bezüglich: Erhöhung der maximalen Anzahl an Mgmt für für Vorstandsmitgliedern von 7 auf 9 5 Wiederwahl, Nominierung und/oder Bestätigung von Mitgliedern des Vorstands Mgmt für für 6 Ermächtigung zur Ausgabe von Aktien oder aktiengebundenen Anleihen ohne Mgmt für gegen Bezugsrechte 7 Ermächtigung zur zusätzlichen Ausgabe von wandelbaren und nicht wandelbaren Mgmt für für Schuldverschreibungen und/oder Schuldpapieren 8 Genehmigung zum Rückkauf von Anteilen Mgmt für für 9 Genehmigung für Aufsichtsrat zur Ratifizierung und Umsetzung der genehmigten Mgmt für für Beschlüsse 10 Bestätigung des Versammlungsprotokolls Mgmt für für ES0105200416 Abengoa S.A. 15.10.2005 EGM 1 Vorlage des Aktienrückkaufplans; Ermächtigung des Aufsichtsrats zur Festlegung der Management Für Für Bedingungen für den Aktienrückkaufplan 2 Genehmigung zum Rückkauf von Anteilen Management Für Für 3 Genehmigung für den Aufsichtsrat zur Ratifizierung und Umsetzung der genehmigten Management Für Für Beschlüsse bezüglich: Aktienrückkauf 4 Bestätigung des Versammlungsprotokolls Management Für Für US00339B1070 Abgenix, Inc. 13.06.2005 AGM 1.1 Wahl von R. Scott Greer zum Director Mgmt für für 1.2 Wahl von M.K. Behrens, Ph.D., zum Director Mgmt für für 1.3 Wahl von R.S. Kucherlapati Ph.D., zum Director Mgmt für für 1.4 Wahl von Kenneth B. -
Årsredovisning Med Information Från Form 20-F 2008 Inledning 2
ASTRAZENECA – ÅRSREDOVISNING MED INFORMATION FRÅN FORM 20-F 2008 INLEDNING 2 AstraZeneca och året i korthet 2 Utvecklingen i sammandrag 2 Ordföranden har ordet 4 Koncernchefens översikt 5 FÖRVALTNINGSBERÄTTELSE 8 FÖRVALTNINGSBERÄTTELSE 8 Inledning 8 Omvärldsanalys 9 Strategi, mål och mätetal 12 > Mäta våra resultat 14 > Vår utveckling – Ekonomiska och övriga nyckeltal 15 Resurser, kompetenser och möjligheter 16 > Läkemedel 16 > Forskning och utveckling 17 > Forsknings- och utvecklingsportfölj den 29 januari 2009 22 BOKSLUT 98 > Försäljning och marknadsföring 25 >6 Immateriella rättigheter 2 > Varuförsörjning och produktion 27 > Medarbetare 28 Ekonomisk översikt 31 > Rapporteringsprinciper 31 > Verksamhetsbakgrund och viktiga händelser 2008 32 > Kortfattad analys av perioden jan–dec 2008 33 > Finansiell ställning , inklusive kassafl öde och likviditet – 2008 35 > Omstrukturerings- och synergi- RAPPORT OM ERSÄTTNINGAR 174 kostnader 36 > Kapital och aktieavkastning 37 > Framtidsutsikter 37 > Kortfattad analys av perioden jan–dec 2007 38 > Finansiell ställning, inklusive kassafl öde och likviditet – 2007 40 > Hantering av fi nansiella risker 41 > Viktiga redovisningsprinciper och bedömningar 43 > Övrig redovisnings information 47 YTTERLIGARE INFORMATION 190 VIKTIG INFORMATION FÖR LÄSARE som var tillgänglig vid utarbetandet av denna Användandet av redovisad utveckling, fasta AV DENNA REDOVISNING årsredovisning med information från Form 20-F och valutakurser och ekonomiska mått för kärn- företaget åtar sig inget ansvar för att uppdatera dessa verksamheten framåtriktade kommentarer. Vi identifi erar framåtriktade I förvaltningsberättelsen och i avsnittet Utvecklingen i Risker beträffande framåtriktade kommentarer kommentarer genom ord som till exempel ”förutse”, sammandrag på sidorna 2 och 3 hänvisas till följande Syftet med denna årsredovisning med information från ”tror”, ”förväntar”, ”avser” och snarlika uttryck i sådana mått: Form 20-F är att tillhandahålla information till företagets kommentarer.