Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Bank of America Merrill Lynch 2015 Health Care Conference
30 slides from Theravance Biopharma's conference presentation, May 12, 2015
Slide 1: Theravance Biopharma at BofA Merrill Lynch 2015 Health Care Conference
Theravance Biopharma, Inc. (NASDAQ: TBPH) Rick E Winningham Chief Executive Officer Bank of America Merrill Lynch 2015 Health Care Conference
Slide 2: Cautionary Statement Regarding Forward-Looking Statements
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 m
Slide 3: Theravance Biopharma Today
Theravance Biopharma Today (NASDAQ: TBPH) Theravance Biopharma was created to drive value from a unique and diverse set of assets An approved product A pipeline of high-value assets A productive research platform
Slide 4: The Theravance Biopharma Strategy
The Theravance Biopharma Strategy Payors Partners Acute Care Leverage Our Insights to Make a Difference for Patients and Create Meaningful Value for Shareholders Insight and Innovation Patient Provider Payor
Slide 5: Theravance Biopharma Milestones
Theravance Biopharma Milestones VIBATIV®: targeting 2015 net sales of $20M Initiate LAMA TD-4208 Phase 3 registrational program in 2015 Progression of high value development candidates in heart failure and ulcerative colitis into the clinic in late 2015/early 2016 Completion of 3 Phase 3 studies in
Slide 6: VIBATIV (telavancin)
Theravance ik’ Biopharma A. Medicines That Make a Difference” VIBATIV® (telavancin) Theravance uv Biopharma 7.
Slide 7: 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 8: VIBATIV: Focus for 2015
VIBATIV®: Focus for 2015 Targeting 2015 net sales of approximately $20 million Increasing sales force to 50 reps in targeted U.S. territories Regional partners outside the U.S. contribute cash plus insight to drive commercial success Establishing VIBATIV in the market as a differentiated product In
Slide 9: Why Physicians Choose VIBATIV
Why Physicians Choose VIBATIV® In Vitro Activity Dual Mechanism of Action; Bactericidal against clinically important Gram+ organisms Active against S. aureus strains with reduced susceptibility to other agents VAN MIC > 1 µg/mL VISA, hVISA strains Daptomycin and linezolid-resistant No resistance det
Slide 10: VIBATIV Commercialization
VIBATIV® Commercialization Source: Symphony Sales Data, through March 2015 Robust Growth in New Accounts Since Launch 7 22 39 57 81 107 131 153 173 200 234 253 262 285 319 332 352 372 398 423 0 50 100 150 200 250 300 350 400 450 Accounts with VIBATIV Sales
Slide 11: VIBATIV Expanded Sales Force Intended to Drive Market Uptake
VIBATIV® Expanded Sales Force Intended to Drive Market Uptake Source: Symphony Health Source Non-Retail Sales Data, March 2015 data month MTM Sales Volume; Growth Outpaced Competition in March 0 200 400 600 800 1,000 1,200 1,400 1,600 1,800 Nov-14 Dec-14 Jan-15 Feb-15 Mar-15 VIBATIV 250mg & 750mg Vo
Slide 12: Telavancin Phase 3 Study in Bacteremia
Telavancin Phase 3 Study in Bacteremia Trial, if successful, designed to support regulatory filing and label expansion1 Multi-center, randomized, open-label study in ~250 patients at ~70 clinical sites in the U.S. and ROW initiated February 2015 Study will evaluate non-inferiority of telavancin vs.
Slide 13: VIBATIV Indication Profile
VIBATIV® Indication Profile (*) Complicated or Acute Bacterial Skin or Skin Structure Infection Potential for Broadest Set of Indications Among Branded Anti-MRSA telavancin ceftaroline dalbavancin daptomycin linezolid oritavancin tedizolid Compound Indications SSSI* HABP/VABP Bacteremia Registration
Slide 14: TD-4208
Theravance ik’ Biopharma AK. Medicines That Make a Difference” TD-4208 Theravance uv Biopharma 7”
Slide 15: TD-4208: Potential First Once-daily Nebulized Bronchodilator
TD-4208: Potential First Once-daily Nebulized Bronchodilator Goal: Standard of Care in Nebulized Therapy 1 Global Strategy for Diagnosis, Management, and Prevention of COPD 2 Encuity Research, LLC., TreatmentAnswers™ (2013) 3 TBPH market research (N = 160 physicians) 4Estimate derived from use of in
Slide 16: Limited Nebulized Bronchodilators for COPD Available
Limited Nebulized Bronchodilators for COPD Available No Nebulized LAMAs and No Once-daily Products of any Class Frequency Class Handheld segment Nebulized segment 4x daily SAMA SABA SAMA/SABA 2x daily LAMA LABA 1x daily LAMA LABA LAMA/LABA First-in-Class Opportunity No once-daily marketed nebulized
Slide 17: TD-4208 Demonstrates Clinically Meaningful Improvements in Lung Function
TD-4208 Demonstrates Clinically Meaningful Improvements in Lung Function in COPD Patients Study 0117 Met Primary Endpoint at Doses of 88 mcg and Above 355 patients with moderate to severe COPD Primary endpoint: Change from baseline in trough FEV1 following 28 days Note: FEV1 = forced expiratory volu
Slide 18: 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 19: TD-4208: Phase 3 Registrational Program
TD-4208: Phase 3 Registrational Program Plan to initiate Phase 3 program in second half of 2015 Phase 3 program Two replicate 3-month efficacy studies expected to read-out in 2016 Single 12-month safety study expected to read-out in 2017 ~2,200 patients across three studies Studies will test two dos
Slide 20: NEPI Program
Theravance ik’ Biopharma AV. Medicines That Make a Difference” NEPI Program Theravance uv Biopharma 7
Slide 21: Potential Best-in-Class NEPI for Congestive Heart Failure
Focus: Potential Best-in-Class NEPI that could Transform the Treatment of Congestive Heart Failure Fixed 1:1 ratio with valsartan Renal clearance Novartis (Sacubitril) Flexible NEP:ARB ratio Non-renal clearance Theravance Biopharma (NEPI) Constraints Challenge to dose patients with severe renal impa
Slide 22: Primary Endpoint: CV Death or HF Hospitalization
Primary Endpoint: CV Death or HF Hospitalization1,2 LCZ696 (1:1 Valsartan:Sacubitril) 20% 1McMurray et al (2014) N Engl J Med, 371:993-1004 2Solomon et al (2012) Lancet, 380:1387-95 3TBPH estimate based on integrating data from multiple sources ARNI (ARB + NEPI) Class of Medicines may be a Paradigm
Slide 23: Sustained Ang II Receptor Blockade in Preclinical Model
Sustained Ang II Receptor Blockade in Preclinical Model Potential to treat patients with renal impairment Ability to titrate both ARB and NEP to the maximum benefit of any patient type Value inflection Phase 1b / 2a Sustained Neprilysin Inhibition in Preclinical Model Objective: Best ARB + Best NEPI
Slide 24: Theravance Biopharma Value Creation
Theravance Biopharma Value Creation
Slide 25: Theravance Biopharma Milestones
Theravance Biopharma Milestones VIBATIV®: targeting 2015 net sales of $20M Initiate LAMA TD-4208 Phase 3 registrational program in 2015 Progression of high value product candidates in heart failure and ulcerative colitis into the clinic in late 2015/early 2016 Completion of 3 Phase 3 studies in 2016
Slide 26: Theravance Biopharma Value Creation
Theravance Biopharma Value Creation † 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 marketable secu
Slide 27: Thank you
Theravance ik’ Biopharma A. Medicines That Make a Difference” Thank you Theravance i Biopharma 7’.
Slide 28: 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 29: 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 30: Q&A Session
Theravance ik’ Biopharma AV. Medicines That Make a Difference” Q&A Session Theravance uv Biopharma AY.
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