Viatris Inc. · NASDAQ:VTRS
Viatris — Mylan Laboratories — Investor Presentation (June 2005)
47 slides from Viatris's investor presentation, Jun 14, 2005
Slide 1: Strategic Update and Business Outlook
June 14, 2005 Mylan Laboratories Inc. Strategic Update and Business Outlook
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation will include statements that constitute "forward-looking statements", including with regard to the Company's future business and financial performance including its revenues and earnings per share; the anticipated effects of today's announcements; and the
Slide 3: Robert J. Coury, Vice Chairman and CEO
Robert J. Coury Vice Chairman and Chief Executive Officer 3
Slide 4: Key Developments
Key Developments Update on Nebivolol Update on Mylan Bertek
Slide 5: Key Developments: Nebivolol
Key Developments Nebivolol Next-generation beta blocker for the treatment of hypertension Approvable Letter on NDA for hypertension received May 31, 2005 Intend to partner with major pharmaceutical company to maximize nebivolol opportunity
Slide 6: Key Developments: Closing Mylan Bertek
Key Developments Closing Mylan Bertek Internal operational efficiencies Significant enhancement to EPS
Slide 7: Mylan Technologies / UDL: Subsidiary Achievements
Mylan Technologies / UDL: Subsidiary Achievements UDL: Largest unit dose packager in the US Shipped over 800 million doses in fiscal 2005 400 line items individually blistered, labeled and bar coded Well positioned to capitalize on growth opportunities Mylan Technologies: Transdermal drug delivery p
Slide 8: Generics: Update
Generics: Update Generics remain the core of our business Significant change over the past 18 months: Authorized generics Regulatory, legal changes Increased competition in base business Mylan took action -- industry leader in government relations Early on, Mylan foresaw the generic industry challen
Slide 9: Generics: Strategy
Generics: Strategy Mylan is a dominant force in pharmaceuticals: The leading domestic generic pharmaceutical company Over 200 million prescriptions dispensed Unmatched science, manufacturing and distribution capabilities Product innovation and selection is critical: generic product cycle runs 3-5 ye
Slide 10: History of Long-Term Sales Growth
Revenue Stock Price 1961 22 0.59 ... 0.59 1984 36.9 0.59 0.59 1985 53.6 2.04 1986 80.844 2.25 1987 95.135 2.48 1988 96.017 1.44 1989 87.93 1.26 1990 95.415 2.93 1991 91.082 3.98 1992 131.936 5.61 1993 211.964 8.59 1994 251.773 5.19 1995 396.12 9.41 1996 392.86 9.33 1997 440.1919 6.56 1998 555.4229 1
Slide 11: Capital Structure Changes
Capital Structure Changes $1.25 Billion share buy-back Up to $1 billion Dutch auction tender at a price range of $18.00 to $20.50 per share Follow on $250 million buyback in the open market or otherwise Total repurchase of nearly 25% of shares outstanding, assuming 65 million shares at $19 per share
Slide 12: Adjusted EPS Guidance: Fiscal 2006 and 2007
Adjusted EPS Guidance: Fiscal 2006 and 2007(1) Fiscal 2006 EPS Range of $0.92 to $1.15 Fiscal 2007 EPS Range of $1.20 to $1.74 (1) All references to adjusted EPS and GAAP EPS throughout this presentation relate to diluted EPS
Slide 13: Presentation Agenda
Presentation Agenda Name Title Agenda John O'Donnell, Ph.D. Chief Scientific Officer Nebivolol Clinical Overview Carolyn Myers, Ph.D. Vice President, Strategic Marketing The Commercial Opportunity for Nebivolol Edward Borkowski Chief Financial Officer Financial Guidance
Slide 14: Nebivolol: Overview of Clinical Program
Nebivolol: Overview of Clinical Program John O'Donnell, Ph.D. Chief Scientific Officer 27
Slide 15: dl-Nebivolol
dl-Nebivolol O F H N OH O OH F * * * * Nebivolol Composition of matter patent expiration in 2020
Slide 16: Nebivolol Clinical Overview
Nebivolol Clinical Overview Studies filed in the hypertension NDA Proposed near term life cycle management plan and long term study considerations Menarini's trial in congestive heart failure in the elderly (SENIORS)
Slide 17: Nebivolol: U.S. Registration Trials in Patients With Hypertension
Nebivolol: U.S. Registration Trials in Patients With Hypertension Monotherapy vs. placebo Trial 302 (General population)* Trial 305 (General population) Trial 202 (African-American patients) Add-on therapy vs. placebo Trial 321 (Nebivolol added to current antihypertensive treatment) Long-term safety
Slide 18: Near Term Life Cycle Management Program
Near Term Life Cycle Management Program Studies Focused in Hypertensive Patients Confirming the benefits in African Americans Comparing the tolerability of nebivolol Conducting studies in metabolic syndrome patients Differentiating nebivolol from other major beta blockers
Slide 19: Long Term Study Consideration
Long Term Study Consideration Further exploration of nitric oxide effects of nebivolol Effects of nebivolol therapy on blood vessels Effects of nebivolol on the kidney Effects of nebivolol on exercise tolerance Outcomes study
Slide 20: SENIORS Trial
SENIORS Trial* Study of Effects of Nebivolol Intervention on Outcomes and Rehospitalization in Seniors with Heart Failure Study Objective: To evaluate the effect of nebivolol compared with placebo on mortality and morbidity in elderly patients with CHF With preserved or diminished Left Ventricular E
Slide 21: Nebivolol: The SENIORS Study
Nebivolol: The SENIORS Study SENIORS was conducted by Menarini Research In February 2005, SENIORS was submitted through Mutual Recognition to obtain a CHF indication in EU Mylan has signed a collaboration agreement with Menarini to have access to the SENIORS trial In collaboration with Menarini, Myl
Slide 22: Study Administrative Organization
Study Administrative Organization Steering Committee: Philip Poole-Wilson (UK), Andrew Coats (AUS) (Co-Chairs), Anker S, Bohm M, Borbola J, Cohen-Solal A, Dumitrascu D, Ferrari R, Flather M, Lechat P, Parkhomenko A, Shibata M, Soler-Soler J, Spinarova L, Tavazzi L, Toman J, Van Veldhuisen D Clinical
Slide 23: Summary of Clinical Program
Summary of Clinical Program Approvable Letter on NDA for hypertension received May 31, 2005 Near term Life Cycle Management program to continue to differentiate nebivolol from other major beta blockers Long term studies to further enhance clinical knowledge of the unique in vitro properties of nebiv
Slide 24: The Commercial Opportunity for Nebivolol
The Commercial Opportunity for Nebivolol Carolyn Myers, Ph.D. Vice President, Strategic Marketing 49
Slide 25: Cardiovascular Market is a Compelling US Business Opportunity
Cardiovascular (CV) Market is a Compelling US Business Opportunity 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 TRx 259775 280325 297033 315632 334673 354612 385034 419011 457654 489745 518859 544905 578999 Sales 6990403 7252014 7679739 8063875 8159206 8547053 10713177 11777702 1
Slide 26: Beta Blockers Account for Large and Growing Segment of CV Market
Source: IMS National Sales Perspectives, Total Dollar Sales; IMS National Prescription Audit, TRx Beta Blockers Account for Large and Growing Segment of the CV Market 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 BB 1319558 1175973 1039787 987570 974883 977723 1249617 1434989 1826
Slide 27: Nebivolol is a Global Product
Nebivolol is a Global Product Approved in over 65 countries Registrational status as of April 2005.
Slide 28: Nebivolol is a Global Product: Registration Pending
Nebivolol is a Global Product Approved in over 65 countries Registration pending Registrational status as of April 2005.
Slide 29: Nebivolol has Successful Track Record in Europe
Nebivolol has Successful Track Record in Europe 1997 1998 1999 2000 2001 2002 2003 2004 Sales 4126 12183 31566 48735 67441 88678 124819 158203 Units 7890 23348 67361 121973 174169 220439 275798 325059 *Compounded annual growth both in terms of prescriptions and dollars has increased by 17% and 24%,
Slide 30: Driven by Success in Germany and Italy
Driven by Success in Germany and Italy 1997 1998 1999 2000 2001 2002 2003 2004 France 0 0 0 0 0 0 0 2810 Germany 4123 11473 17891 20921 26876 34713 51528 61282 Italy 0 0 10459 21388 28829 35167 43607 52653 Spain 0 248 1505 2752 4624 6661 9472 11572 UK 0 0 182 1019 2282 3483 4904 6729 Europe 4126 121
Slide 31: Nebivolol's Commercial Evolution is Poised for Growth
Other Potential Indications Heart Failure Hypertension Nebivolol's Commercial Evolution is Poised for Near and Long Term Growth
Slide 32: Nitric Oxide: A Next Frontier for Discovery
Nitric Oxide: A Next Frontier for Discovery > 67,000 nitric oxide citations in PubMed 35 companies exploring the emerging pathophysiology of nitric oxide* 1950-1979 1980-1989 1990-1999 2000-2005 Pubications 463 882 30963 34981 *Source: Mindbranch and LeadDiscovery Pharma Market Research Reports: Car
Slide 33: Positioned With A Clear Competitive Focus
Positioned With A Clear Competitive Focus 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 Atenolol 21768 24498 27386 31541 36142 40373 43577 45208 46023 47289 Metoprolol IR 8657 10413 11836 13757 15546 17758 19563 21014 22361 24798 Toprol XL 2699 4337 6279 8256 10235 12990 17190 23722 29730 35024
Slide 34: A Strong Commercialization Plan Is Integral To Success
A Strong Commercialization Plan Is Integral To Success Medical Education Sales & Marketing Market Development Lifecycle Management COMPREHENSIVE AND INTEGRATED SUPPORT
Slide 35: Financial Guidance
Financial Guidance Edward J. Borkowski Chief Financial Officer 71
Slide 36: Adjusted EPS Guidance: Fiscal 2006 and 2007
Adjusted EPS Guidance: Fiscal 2006 and 2007(1) Fiscal 2006 EPS Range of $0.92 to $1.15 Fiscal 2007 EPS Range of $1.20 to $1.74 5-Year EPS Compound Annual Growth Rate (CAGR) of approximately 20% (1) All references to adjusted EPS and GAAP EPS throughout this presentation relate to diluted EPS
Slide 37: Guidance Assumptions
Guidance Assumptions Product Pipeline: Detailed product-by-product review based on historical performance, current market conditions and future trends Over 45 new products, including six first-to-files, projected to launch in fiscal 2006-2007 Low end of guidance assumes no Paragraph IV wins High end
Slide 38: Guidance Assumptions: Out-license Nebivolol and Recapitalization
Guidance Assumptions Out-license Nebivolol No royalty revenue projected in fiscal 2006; minimal royalty revenue in fiscal 2007 Assumes no R&D or selling and marketing expenses Excludes any potential milestone payments Recapitalization Assumes close of $1 billion self-tender on July 15, 2005 and $250
Slide 39: Fiscal 2006 and 2007 Adjusted Guidance
Fiscal 2006 and 2007 Adjusted Guidance Fiscal 2006 Fiscal 2007 Net Revenues (in millions) $1,135 - $1,340 $1,250 - $1,600 Gross Margins* 52-54% 53-56% R&D* 6-8% 6-8% SG&A* 13-16% 12-15% Operating Margins* 28-35% 30-38% Tax Rate 34-36% 34-36% EPS - adjusted $0.92 - $1.15 $1.20 - $1.74 *stated as a pe
Slide 40: Revenue Guidance
Revenue Guidance (in millions) Fiscal 2006 Fiscal 2007 Base business $1,100 - $1,200 $1,000 - $1,100 New products $35 - $140 $250 - $500 Total $1,135 - $1,340 $1,250 - $1,600
Slide 41: Investing in Generic Research & Development
Investing in Generic Research & Development FY99 FY00 FY01 FY02 FY03 FY04 FY05 FY06E FY07E R&d 58.7 39.2 47.2 33.814 44.562 59.066 68.859 78 85 $ in millions
Slide 42: Capital Expenditures
Capital Expenditures FY02 FY03 FY04 FY05 FY06E FY07E CapEx 20.6 32.6 118.5 90.7 128 68 $ in millions Maintenance capex returns to normalized range of $40 to $50 million in FY '08
Slide 43: Financial Summary
Financial Summary $1.25 billion share buyback, expected to represent nearly 25% of the Company's stock Doubling annual dividend effective June 30, 2005 Strongest product pipeline in Company's history Strong cash flows Fiscal 2006 adjusted EPS range of $0.92 to $1.15 Fiscal 2007 adjusted EPS range of
Slide 44: Additional Information About the 2005 Annual Meeting
IN CONNECTION WITH MYLAN'S 2005 ANNUAL MEETING OF SHAREHOLDERS (THE "ANNUAL MEETING"), MYLAN WILL FILE RELEVANT MATERIALS WITH THE SECURITIES AND EXCHANGE COMMISSION (THE "SEC"), INCLUDING A PRELIMINARY PROXY STATEMENT AND A DEFINITIVE PROXY STATEMENT. INVESTORS AND SHAREHOLDERS OF MYLAN ARE URGED T
Slide 45: Appendix
Appendix 91
Slide 46: Reconciliation of Adjusted EPS Guidance to GAAP EPS Guidance
Fiscal 2006 Low High Adjusted EPS $0.92 $1.15 Mylan Bertek expenses including nebivolol ($0.11) ($0.11) Restructuring charges and other non-recurring expenses ($0.05) ($0.05) GAAP EPS $0.76 $0.99 Reconciliation of Adjusted EPS Guidance to GAAP EPS Guidance (1) (1)Fiscal 2007 guidance excludes any po
Slide 47: Questions and Answers
Ml) Mylan Laboratories Inc. vee Questions and Answers
Mylan Laboratories — Investor Presentation (June 2005) on 6ix