Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Investor Presentation (January 2016)
25 slides from Theravance Biopharma's investor presentation, Jan 11, 2016
Slide 1: 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 2: Theravance Biopharma Investment Highlights
Theravance Biopharma Investment Highlights Productive Research Engine Pipeline of High Value Assets Robust Business Model Team Track Record of Success Strong Financial Position
Slide 3: Optimizing Pipeline Value by Leveraging Partnerships and Commercial Infrastructure
Optimizing Pipeline Value by Leveraging Partnerships and Commercial Infrastructure Late-stage = Regulatory submission filed, Phase 3 development, Phase 3-ready; Mid-stage = assets between Phase 1 and Phase 2b; Early-stage = pre-clinical assets *TBPH holds economic interest in future payments that ma
Slide 4: 2016 Focus
Program Phase 1 Phase 2 Phase 3 Filed Approved VIBATIV® (telavancin) cSSSI, HABP/VABP sNDA Concurrent Bacteremia & cSSSI sNDA Concurrent Bacteremia & HABP/VABP Phase 3 Registrational Study – Bacteremia Revefenacin (TD-4208) Phase 3 Efficacy Studies (2) – COPD Phase 3 Long-Term Safety Study – COPD TD
Slide 5: Neprilysin Inhibitor (NEPi) Program
Neprilysin Inhibitor (NEPi) Program Potential Best-in-Class Therapeutic for Cardiovascular and Renal Disease
Slide 6: Best-in-Class NEPi Could Improve Treatment Regimens for Cardiovascular & Renal Diseases
Best-in-Class NEPi Could Improve Treatment Regimens for Cardiovascular & Renal Diseases Source: © 2015 Decision Resources, LLC. All rights reserved. Reproduction, distribution, transmission or publication is prohibited. Reprinted with permission. All estimates US. Utility of NEP Inhibitors (NEPi) La
Slide 7: TBPH NEPi Program: Differentiated & Versatile Platform
TBPH NEPi Program: Differentiated & Versatile Platform with Potential for Broad Applicability Beyond CHF Range of Cardiovascular and Renal Indications Potential Points of Differentiation Phase 1 Clinical Trial Initiated December 2015 Additional development candidates advancing Key value inflection P
Slide 8: TD-1473 Oral GI-Targeted Pan-JAK Inhibitor
TD-1473 Oral GI-Targeted Pan-JAK Inhibitor for Ulcerative Colitis and Other Inflammatory Intestinal Diseases
Slide 9: Significant Need Remains for Therapies to Treat Moderate to Severe Ulcerative Colitis
1 www.ccfa.org Clinical data: Not head to head comparisons. Clinical data sources: Remicade & Entyvio, Prescribing Information; Ozanimod, Sandborn et al., 2015 Tofacitinib, Sandborn et al., 2012. Significant Need Remains for Therapies to Treat Moderate to Severe Ulcerative Colitis (UC) UC is a Compl
Slide 10: TD-1473: Oral GI-Targeted JAK Inhibitor with Potential for Robust Efficacy
TD-1473: Oral GI-Targeted JAK Inhibitor with the Potential for Robust Efficacy and Minimal Side Effects Phase 1 Clinical Trial Initiated December 2015 TD-1473 Exhibits GI-Restriction after Oral Administration in Rodents TD-1473 is Active in Rodent Colitis Model without Systemic Effects Pharmacokinet
Slide 11: Revefenacin (TD-4208) Nebulized LAMA
Revefenacin (TD-4208) Nebulized Long-Acting Muscarinic Antagonist (LAMA)
Slide 12: Compelling Need for Once-Daily Nebulized LAMA
Compelling Need for Once-Daily Nebulized LAMA 1 Global Strategy for Diagnosis, Management, and Prevention of COPD COPD = Chronic Obstructive Pulmonary Disease 2 TBPH market research (N = 160 physicians); Refers to US COPD patients 3Estimate derived from use of information under license from IMS Heal
Slide 13: Revefenacin (TD-4208) Phase 3 Program
Revefenacin (TD-4208) Phase 3 Program 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 Study 0117 Met Primary Endpoint at 88
Slide 14: Strategic Collaboration with Mylan
Strategic Collaboration with Mylan 1 Applies through FDA approval of first product containing 4208 Nebulized Revefenacin for COPD and Other Respiratory Diseases A world-leader in nebulized therapy Expert in manufacturing and marketing of respiratory products $15M initial payment and $30M equity inve
Slide 15: VIBATIV (telavancin)
VIBATIV® (telavancin) Commercial, Once-Daily, Dual Mechanism Antibiotic
Slide 16: 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 17: Opportunity Exists for VIBATIV Among Alternative MRSA Therapies
Opportunity Exists for VIBATIV® Among Alternative MRSA Therapies in Current U.S. Market Source: TBPH estimates based on integrating data from multiple sources (2014) *Others includes Tygacil and Synercid 79% 21% Total Days of Therapy (DOT) for MRSA Antibiotics 34 Million Vancomycin Alternatives
Slide 18: VIBATIV Commercialization
VIBATIV® Commercialization 1Formularies based on field intelligence; 2TBPH Market Research; 3Q4 estimated US Net Product Sales range: $2.6 million - $3.0 million Steady Growth in Formulary Wins and Product Sales Physicians use VIBATIV when2 “other agents fail” “need rapid bactericidal activity” “pat
Slide 19: VIBATIV: Building a Global Brand
VIBATIV®: Building a Global Brand 1“Treatment Trends®: Hospital Discharge and Outpatient Parenteral Antibiotic Therapy (US)” © June 2014 DR/Decision Resources, LLC. All rights reserved. Reproduction, distribution, transmission or publication is prohibited. Reprinted with permission; Note: This analy
Slide 20: Theravance Biopharma Opportunities for Value Creation
Theravance Biopharma Opportunities for Value Creation
Slide 21: Upcoming Key Milestones
Upcoming Key Milestones Program Milestone Target TD-0714 (NEP inhibitor) Complete Phase 1 (incl. target engagement) 2016 TD-1473 (JAK inhibitor) Complete Phase 1 2016 Revefenacin (TD-4208) Complete Phase 3 Efficacy Studies 2016 Revefenacin (TD-4208) Complete Phase 3 LTSS 2017 VIBATIV® (telavancin) C
Slide 22: Theravance Biopharma Investment Highlights
Theravance Biopharma Investment Highlights Productive Research Engine Pipeline of High Value Assets Robust Business Model Team Track Record of Success Strong Financial Position
Slide 23: 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 24: 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 va
Slide 25: VIBATIV (telavancin) Important Safety Information (US)
VIBATIV® (telavancin) Important Safety Information (US) Mortality Patents wih pre-existing moderatelsevere renal imparment (CrC 50 mLini) who were ead with VIBATIV® fr hospts-acquired bacterial peumonia/ventlatr-ssocited bactral pneumonia had increased morally served versus vancomycin. Use of VIBATI
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