Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Wedbush PacGrow Healthcare Conference 2015
26 slides from Theravance Biopharma's conference presentation, Aug 12, 2015
Slide 1: Wedbush PacGrow Healthcare Conference
Wedbush PacGrow Healthcare Conference August 12, 2015 Theravance Biopharma, Inc. (NASDAQ: TBPH) Rick E Winningham, Chief Executive Officer
Slide 2: Cautionary Statement Regarding Forward-Looking Statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company are subject to risks and uncertainties that may cause actual results to differ materially from the forw
Slide 3: Theravance Biopharma Investment Highlights
Theravance Biopharma Investment Highlights † TBPH is entitled to receive an 85% economic interest in any future payments that may be made by GSK pursuant to its agreements with Theravance, Inc. relating to the Closed Triple program and the MABA program. ‡ Includes cash, cash equivalents and marketab
Slide 4: VIBATIV (telavancin) Commercial, Once-Daily, Dual Mechanism Antibiotic
VIBATIV® (telavancin) Commercial, Once-Daily, Dual Mechanism Antibiotic
Slide 5: What is VIBATIV?
What is VIBATIV®? First FDA approved lipoglycopeptide exhibiting concentration-dependent bactericidal activity via a dual mechanism of action that inhibits cell wall synthesis and disrupts membrane barrier function Active against Gram-positive bacteria, including methicillin-resistant Staphylococcus
Slide 6: VIBATIV: Focus for 2015
VIBATIV®: Focus for 2015 1Includes U.S. net sales, revenue from ex-U.S. sales and sales and milestones generated from ex-U.S. partnerships Targeting 2015 worldwide revenue1 of $15-18 million Increasing U.S. sales force to 50 reps in targeted territories Leveraging regional partners outside the U.S.
Slide 7: VIBATIV Commercialization: Steady Growth in Accounts and Formulary Wins
VIBATIV® Commercialization Source(s): Account data from Symphony Sales, through June 2015; Formularies based on field intelligence 1As reported August 10, 2015 Steady Growth in Accounts and Formulary Wins Important metric for in-hospital antibiotics; on track to achieve 2015 goal 79 formularies YTD
Slide 8: VIBATIV Commercialization: Month-to-Month Sales Volume
VIBATIV® Commercialization 1Percent change on total mgs sold 2Symphony Sales Data, through June 2015 Clinical data, MSLs and publications driving physician education Physician know-how and experience driving usage Physicians use VIBATIV when3 “other agents fail” “need rapid bactericidal activity” “p
Slide 9: Telavancin Phase 3 Study in Bacteremia
Telavancin Phase 3 Study in Bacteremia Trial designed to support regulatory filing and potential label expansion1 ~250 patients at ~70 clinical sites in the U.S. and ROW initiated February 2015 Only two antibiotics approved in the U.S. for the treatment of MRSA bacteremia; treatment failure is commo
Slide 10: VIBATIV: Potential for Broadest Set of Indications Among Branded Anti-MRSA Agents
VIBATIV®: Potential for Broadest Set of Indications Among Branded Anti-MRSA Agents (*) Complicated or Acute Bacterial Skin or Skin Structure Infection telavancin ceftaroline dalbavancin daptomycin linezolid oritavancin tedizolid Compound Indications SSSI* HABP/VABP Bacteremia Registrational Study
Slide 11: TD-4208 Nebulized Long-Acting Muscarinic Antagonist (LAMA)
TD-4208 Nebulized Long-Acting Muscarinic Antagonist (LAMA)
Slide 12: TD-4208: Compelling Need for Once-Daily Nebulized LAMA
TD-4208: Compelling Need for Once-Daily Nebulized LAMA 1 Global Strategy for Diagnosis, Management, and Prevention of COPD 2 TBPH market research (N = 160 physicians); Refers to US COPD patients 3Estimate derived from use of information under license from the following IMS Health information service
Slide 13: Favorable Phase 2b Results Support Phase 3 Registrational Program in COPD
Favorable Phase 2 Results Support Phase 3 Registrational Program in COPD 355 patients with moderate to severe COPD Primary endpoint: Change from baseline in trough FEV1 following 28 days Note: FEV1 = forced expiratory volume in one second TD-4208 (mcg) p-values versus placebo: <0.001*** Phase 2b Stu
Slide 14: Strategic Collaboration with Mylan
Strategic Collaboration with Mylan Significant funding for Theravance Biopharma including $15M initial payment and up to $220M in development/commercialization milestones Profit share in US and low to mid-teen double-digit royalties ex-US TBPH leads development program in U.S. program fully funded b
Slide 15: Neprilysin Inhibitor (NEPi) Program
Neprilysin Inhibitor (NEPi) Program Potential Best-in-Class Therapeutic for Cardiovascular and Renal Disease
Slide 16: Targeting Broad Population of Patients in Large Markets
Targeting Broad Population of Patients in Large Markets Across Range of Cardiovascular and Renal Diseases 1www.circ.ahajournals.org 2www.cdc.gov 3www.cdc.gov 4www.prconline.gov (U.S. estimates) Neprilysin Inhibitor (NEPi) Acute Heart Failure Chronic Heart Failure Chronic Kidney Disease Treatment- Re
Slide 17: NEP: Key Therapeutic Target for Cardiovascular and Renal Diseases
NEP: Key Therapeutic Target for Cardiovascular and Renal Diseases Degradation of natriuretic peptides Reduction in mortality and morbidity in CHF patients Diuresis Control of blood pressure Reversal of maladaptive changes in heart and vascular tissue Utility of NEP in Cardiovascular and Renal Diseas
Slide 18: ARNI Class of Medicines: Potential Paradigm Shift for Congestive Heart Failure
ARNI (ARB + NEPI) Class of Medicines: Potential Paradigm Shift for Patients with Congestive Heart Failure Cardiorenal function End-organ damage Mortality and hospitalization Entresto® FDC of valsartan (ARB) and sacubitril (NEPI) Indicated to reduce risk of CV death and hospitalization for HF patient
Slide 19: NEPi Program: Versatile Platform Across Wide Spectrum of Treatments
NEPi Program: Versatile Platform Across Wide Spectrum of Treatments Disease Indications Clinical Validation1 Preclinical Validation2 Chronic Heart Failure Acute Heart Failure Hypertension Chronic Kidney Disease ARB Combination (ARNI) Optimized for CHF and/or CKD 1 Using LCZ696/omapatrilat 2 Using ca
Slide 20: Theravance Biopharma Value Creation
Theravance Biopharma Value Creation
Slide 21: Theravance Biopharma Milestones to Value Creation
VIBATIV®: targeting 2015 worldwide revenue1 of $15-18 million Initiation of LAMA TD-4208 Phase 3 registrational program second half 2015 Progression of high value development candidates in cardiovascular / renal disease and ulcerative colitis into the clinic in late 2015/early 2016 Completion of 3 P
Slide 22: Theravance Biopharma Investment Highlights
Theravance Biopharma Investment Highlights Value Creation Acute Care Commercial Strategy Led by VIBATIV® Pipeline of High Value Assets Strong Financial Position Productive Research Engine Team Track Record of Success Closed Triple Financial Assets
Slide 23: Thank You
Theravance ik’ Biopharma AK. Medicines That Make a Difference” Thank You
Slide 24: About VIBATIV (telavancin)
About VIBATIV® (telavancin) VIBATIV was discovered internally in a research program dedicated to finding new antibiotics for serious infections due to Staphylococcus aureus and other Gram-positive bacteria, including MRSA. VIBATIV is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic
Slide 25: VIBATIV (telavancin) Important Safety Information (US)
VIBATIV® (telavancin) Important Safety Information (US) Mortality Patients with pre-existing moderate/severe renal impairment (CrCl <50 mL/min) who were treated with VIBATIV® for hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia had increased mortality observed versus v
Slide 26: Q&A Session
Theravance ik’ Biopharma AV. Medicines That Make a Difference” Q&A Session
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