Ligand Bio Presentation


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Ligand Bio Presentation

  1. 1. 14th Annual BIO CEO and Investor ConferenceFebruary 13, 2012John HigginsPresident and Chief Executive Officer
  2. 2. Safe Harbor Statement The following presentation contains forward-looking statements regarding Ligand’s prospects, plans and strategies, drug development programs and collaborations. Forward-looking statements include financial projections, expectations regarding research and development programs, and other statements including words such as “will,“ “should,” “could,” “plan,” etc. Actual events or results may differ from Ligand’s expectations. For example, expense reductions and drug development programs may not be realized. In addition there can be no assurance that Ligand will achieve its guidance in 2012 or thereafter. The forward-looking statements made in the presentation are subject to several risk factors, including, but not limited to, statements regarding intent belief or current expectations of the Ligand its internal and partnered to intent, belief, Ligand, programs, including Promacta, Ligand’s reliance on collaborative partners for milestone and royalty payments, regulatory hurdles facing Ligands and partners product candidates, uncertainty regarding Ligands and partners product development costs, the possibility that Ligands and partners drug candidates might not be proved to be safe and efficacious and commercial performance of Ligands and/or its partners products. Additional risks may apply to forward looking statements made in this presentation forward-looking presentation. The risk factors facing Ligand are explained in greater detail in Ligand’s filings with the SEC, including the most recently filed annual reports on Form 10-K and quarterly reports on Form 10-Q, as well as other public filings. While forward-looking statements reflect our good faith beliefs (or those of the indicated third parties), they are not guarantees of future performance. We disclaim any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.2
  3. 3. Ligand 2012 3 Focus Points for Investors Unprecedented Asset  p Portfolio f Revenue Expansion Potential Expansion Potential Investment  Leverage L3
  4. 4. Late-Stage Assets to Watch in 2012 12 in 2012 We expect these programs are either starting or ending PIII studies, filing  NDAs or hearing decisions from the FDA in 2012 Carfilzomib (Onyx) – FDA Review of NDA Delafloxacin (Rib‐X) – Initiate PIII Promacta (GSK) – File sNDA for HepC (GSK)  File sNDA for HepC CE‐Melphalan (Ligand) – Initiate Pivotal (Ligand) – Initiate Pivotal Aprela (Pfizer) – File NDA Dinaciclib (Merck) – Initiate PIII CE Carbamazepine (Lundbeck) PIII Readout CE‐Carbamazepine (Lundbeck)– PIII Readout Merck Undisclosed CE  Initiate Pivotal Merck Undisclosed CE – Initiate Pivotal CE‐Clopidogrel (MDCO) – Initiate Pivotal Study Lilly Undisclosed CE – Initiate PIII Promacta (GSK) – Initiate PIII Oncology ( ) gy Hospira Undisclosed CE – Initiate Pivotal p4
  5. 5. Illustrative Revenue Growth Potential "Shots on Goal"    2015 Vision                                                                                   Vision Promacta Turning into Reality Carfilzomib 2012 Avinza Conbriza Nexterone Promacta Aprela Avinza Dinaciclib Conbriza CE‐Clopidogrel p g Nexterone N t CE‐Melphalan Captisol Material Sales CE‐Carbamazepine License/Milestone Fees Lilly CE Program Hospira CE Program p g $30M Captisol Material Sales License/Milestone Fees $150 200M $150-200M5
  6. 6. Ligand’s Partnered Portfolio More than 50 Partnered Programs M th 50 P t dP Approved/  Over 25 Different Partners Marketed k d 16% Over 10 Different Therapeutic Areas Phase III/NDA  Over 50% in Phase II or Later Phase I Phase I 12% 35% Phase II 30%6
  7. 7. The Value of Ligand’s Partnered Portfolio Unprecedented Size Unprecedented Size Enables High Probability of Success7
  8. 8. The Value of Ligand’s Partnered Portfolio Substantial Upside Major News Flow Diverse Revenue Sources Diverse Revenue Sources Multiple Blockbuster Programs8
  9. 9. The Value of Ligand’s Partnered Portfolio Highly Diversified g y Lowers Risk More Ways to Succeed More Ways to Succeed9
  10. 10. The Value of Ligand’s Partnered Portfolio Fully Funded y Partners Carry Majority of Risk Allows Ligand to Run Lean Business Allows Ligand to Run Lean Business10
  11. 11. Leveraging Partnerships 2012 Investment E i dP E di Estimated Partner Expenditure >$300 M Ligand Cash Expenses $20 M11
  12. 12. Promacta
  13. 13. Promacta A blockbuster driver for Ligand growth A bl kb t d i f Li d th Approved in all major markets for ITP Marketed by GSK Significant royalty interest Major upcoming 2012 catalysts Major upcoming 2012 catalysts Long patent protection through 2025 Potential for major label expansion13
  14. 14. Promacta A blockbuster driver for Ligand potential growth A bl kb t d i f Li d t ti l th Promacta Annual Sales ($M) Promacta Annual Sales ($M) $140.0  Other EU $120.0  $120.0 US •Dramatic Revenue Acceleration •Dramatic Revenue Acceleration •252% growth in 2011  $100.0  •Promacta is Gaining ITP Market Share vs. Nplate $80.0  $80 0 •17% in 2010 •29% in 2011 $60.0  •Ligand will earn a net 8.3% royalty on $1 billion  $40.0  in annual sales i l l $20.0  $‐ 0 2009 2010 201114
  15. 15. Promacta Hepatitis C Related‐Thrombocytopenia H titi C R l t d Th b t i PIII ENABLE 1 and 2 studies are complete PIII ENABLE 1 d 2 t di l t •Primary endpoint successfully met in both studies •Full data to be presented at 2012 EASL meeting in Barcelona (April) GSK has stated sNDA will be filed in 2012 Potential blockbuster market opportunity for HepC indication alone •8‐10% of all HepC patients world‐wide have thrombocytopenia that limits  their ability to start or complete a HepC anti‐viral treatment1 th i bilit t t t l t H C ti i l t t t •Third party sell‐side analysts project major sales potential for Promacta in  HepC 1Thrombocytopenia in Hepatitis C: Impact on Patient Management
  16. 16. Promacta The Future for Promacta i H C Th F t f P t in HepC Q: Will the new nucleoside inhibitors that are on the horizon eliminate the  Q: Will the new nucleoside inhibitors that are on the horizon eliminate the need for Promacta? A: In Ligand’s view, very unlikely •Promacta’s target HepC patients have underlying cirrhosis,  which hepatologists suggest will require a combination  p g gg q treatment for full cure •These “cocktail” treatments will all likely impact platelets,  meaning Promacta will still be needed to initiate and  g maintain anti‐viral therapy •These new nuclease inhibitors have yet to be tested in  these very sick patients, so data is still needed to determine  their impact on platelets in these patients16
  17. 17. Promacta Th N The Near‐Term Future of the Promacta F T F t f th P t Franchise hi Phase I Phase II Phase III Approved Clinical Studies Approved A d Idiopathic Thrombocytopenia (IT) (11 Label Expansion and LT Safety Studies Ongoing) Hepatitis C‐Related Thrombocytopenia l d h b 2 P-III Studies P III Complete (1 Open-Label Study Ongoing) Oncology‐Related Thrombocytopenia 11 PI and PII St dies Studies• Ligand anticipates the following upcoming Promacta events  Filing of HepC sNDA in 2012  Initiation of Phase III oncology-related trial  Potential start of new Phase III CLD study17
  18. 18. CaptisolFormulationTechnology
  19. 19. Captisol The Need for an Enabling Solubility Technology Th N d f E bli S l bilit T h l “… between 70 and 90% of drug candidates in  pipelines are believed to have low solubility.  In fact,  pipelines are believed to have low solubility In fact poor solubility problems are considered to be the  leading challenge in drug development” ‐ Chemical Engineering News, 201019
  20. 20. Captisol Th S l bilit S l ti The Solubility Solution Patented, chemically-modified cyclodextrin Increase drug solubility, reduce site reactions I d l bilit d it ti Versatile across molecule families and sizes Type V Drug Master File Over 100 clinical studies20
  21. 21. Captisol 2011 D l E di th P t B 2011 Deals Expanding the Partner Base Merck Undisclosed Captisol program The Medicines Company Captisol‐enabled clopidogrel Sage Therapeutics Captisol‐enabled CNS Lilly Captisol platform relationship Hospira Undisclosed Captisol program21
  22. 22. SelectPartnership Highlights
  23. 23. Ligand Partnership Highlight Pfizer Aprela Pfizer has recently announced they will be filing an NDA in 2012 for Aprela Aprela is the combination of Conbriza® (bazedoxifene) and Premarin and is designed as a therapeutic for post- g menopausal symptoms Conbriza, a SERM molecule, was discovered by Ligand and licensed to Wyeth (now Pfizer) in the 1990’s Ligand is entitled to receive milestones and royalties from the Aprela program23
  24. 24. Ligand Partnership Highlight The Medicines Company Captisol‐enabled clopidogrel MEDCO has announced they plan to initiate a pivotal registration study in 2012 for CE-clopidogrel, with potential NDA filing in 2013 l is h i ingrediant in Plavix®, currently Clopidogrel i the active i Cl id di i Pl i l only available orally This program offers the first intravenous formulation of clopidogrel to doctors and patients Ligand is entitled to receive milestones and royalties, and Captisol material sales from the clopidogrel p g program24
  25. 25. Ligand Partnership Highlight Onyx Carfilzomib Onyx has filed the NDA for carfilzomib and currently has an PDUFA date of July, 27, 2012 for an FDA decision Carfilzomib is Captisol-enabled and has shown strong efficacy and safety to date in patients with multiple myeloma Third party analysts predict over $1 billion in peak sales for carfilzomib Ligand is entitled to receive milestones and royalties, and Captisol material sales from the carfilzomib program25
  26. 26. Ligand Partnership Highlight Rib‐X Delafloxacin Rib-X has Rib X h recently completed a PIIb program for the tl l t d f th delafloxacin program and anticipates starting a PIII registration study in 2012 Delafloxacin is a novel hospital-based fluoroquinolone antibiotic formulated with Captisol Fluoroquinolones are a class of broad spectrum antibiotics which kill bacteria by interfering with DNA p replication Ligand is entitled to receive milestones and royalties from the delafloxacin program26
  27. 27. Summary
  28. 28. Financial Highlights 2012 Fi i l G id 2012 Financial Guidance 2012 R 2012 Revenue Composition C iti •$30M in total revenue •$25M in operating expenses ~25% % ‐ Includes $6M non‐cash expense Material  •COGS at 30‐35% of material sales Sales ~ 50% Royalty ~ 25% ~ 25% License  Fees NOLs exceed $500 million 19.7 million shares outstanding28
  29. 29. The Ligand Investment Thesis Promacta is a blockbuster asset that can drive significant valuation Cash‐flow positive with increasing revenue base Uniquely large asset portfolio creates tremendous upside Innovative internal R&D with focus on ROI Innovative internal R&D with focus on ROI 12 in 2012 ‐ potential for major late‐stage news flow this year29