Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — 14th Annual Needham Healthcare Conference (April 2015)
35 slides from Theravance Biopharma's conference presentation, Apr 14, 2015
Slide 1: 14th Annual Needham Healthcare Conference
Rick E Winningham Chief Executive Officer 14th Annual Needham Healthcare 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 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 6: VIBATIV (telavancin)
Theravance ik’ Biopharma A. Medicines That Make a Difference” VIBATIV® (telavancin) Theravance uv Biopharma 7.
Slide 7: What is VIBATIV (telavancin)?
What is VIBATIV® (telavancin)? The 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 Approved in the U.S. for treatment of the following infections in ad
Slide 8: Opportunity Exists for VIBATIV Among Alternative MRSA Therapies
Opportunity Exists for VIBATIV® Among Alternative MRSA Therapies in Current US Market Source: TBPH estimates based on integrating data from multiple sources *Others includes Tygacil and Synercid 79% 21% Total DOTs for MRSA Antibiotics 34 M for 2014 Vancomycin Alternatives
Slide 9: Why Physicians Choose Telavancin
Why Physicians Choose Telavancin tedizolid Potent 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 resi
Slide 10: VIBATIV Commercialization
VIBATIV® Commercialization Source: Symphony Sales Data, thru Feb 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 0 50 100 150 200 250 300 350 400 450 Accounts with VIBATIV Sales
Slide 11: Telavancin Phase 4 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 12: 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 13: VIBATIV: Focus for 2015
VIBATIV®: Focus for 2015 Expanded commercial and medical program in select U.S. territories Field team increased to 21 sales reps and 10 medical sales liaisons (MSLs) Highly experienced institutional reps; Significant medical information focus Regional partners outside the U.S. contribute cash plus
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 Four times daily SAMA SABA SAMA/SABA Twice daily LAMA LABA Once daily LAMA LABA LAMA/LABA No once-daily marketed nebulized bronchodilator
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: TD-4208: Phase 3 Registrational Program
TD-4208: Phase 3 Registrational Program Plan to initiate Phase 3 program in 2015 Trial designed to support regulatory filing 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 program Study will test tw
Slide 19: Closed Triple
Theravance ik’ Biopharma A. Medicines That Make a Difference® Closed Triple Theravance uv Biopharma 7’.
Slide 20: Economic Interest in GSK Respiratory Programs
Economic Interest in GSK Respiratory Programs Opportunity for “Triple Therapy” 1TBPH is entitled to this economic interest through its ownership interest in Theravance Respiratory Company, LLC. 2If MABA medicine containing ‘081 commercialized only as a combination, such as ‘081/FF, the above noted r
Slide 21: GSK/Theravance Closed Triple Addresses a Significant, Growing Patient Segment
GSK/Theravance Closed Triple Addresses a Significant, Growing and High Value Patient Segment 18% of prescribed COPD regimens include co-Rx for LAMA+LABA/ICS1 Patients on triple therapy constitute highest value/greatest need segment These patients represent >40% of total LAMA and LABA/ICS COPD sales
Slide 22: Programs Emerging from Research
Programs Emerging from Research
Slide 23: Focus: Potential Best-in-Class NEPI for Congestive Heart Failure
Focus: Potential Best-in-Class NEPI that could Transform the Treatment of Congestive Heart Failure Off-patent Fixed 1:1 ratio with valsartan Renal clearance Novartis (Sacubitril) IP Filed Flexible NEP:ARB ratio Non-renal clearance Theravance Biopharma (NEPI) Constraints Challenge to dose patients wi
Slide 24: Considerations for LCZ696 ARNI
However, important considerations for LCZ696 ARNI: Inflexible 1:1 valsartan:sacubitril Excluded patients with severe renal dysfunction (~ 1M patients)3 Symptomatic Hypotension Primary Endpoint: CV Death or HF Hospitalization1,2 LCZ696 (1:1 Valsartan:Sacubitril) 20% 1McMurray et al (2014) N Engl J Me
Slide 25: Sustained Ang II Receptor Blockade in Preclinical Model
Sustained Ang II Receptor Blockade in Preclinical Model Best ARB + Best NEPI = Best ARNI Improved efficacy, all HF patients, QD dosing Sustained Neprilysin Inhibition in Preclinical Model Objective: Create a Best-in-Class ARNI (ARB + NEPI) for Heart Failure Value Inflection in Phase 1b / 2a Time (hr
Slide 26: Ulcerative Colitis: A Major Unmet Medical Need Remains
Ulcerative Colitis: A Major Unmet Medical Need Remains ~ 680K patients in the U.S.1 Current treatments have limited efficacy, lose efficacy with time, or are inappropriate for long term use Graham & Xavier (2013) Trends Immunol., 34: 371-378 UC is a complex, heterogeneous disease, and optimal therap
Slide 27: Focus: Oral Small Molecules for Ulcerative Colitis
Focus: Oral Small Molecules for Ulcerative Colitis Restricted to the GI Tract Low risk High Impact Localized Drug Targeted Benefit Systemically-active agent TBPH compound Low dose Healthy Control High dose Rodent GI Inflammation Rodent Pharmacokinetics Systemically-active agent TBPH compound Healthy
Slide 28: Major Unmet Medical Need in Ulcerative Colitis
Major unmet medical need ~ 680K patients in the U.S.1 Current treatments have limited efficacy UC is a complex, heterogeneous disease Optimal therapy may require targeting multiple inflammatory pathways Agents are needed to treat severe, refractory acute disease and provide a sustained response for
Slide 29: Theravance Biopharma Value Creation
Theravance Biopharma Value Creation
Slide 30: 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 31: 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 32: Thank you
Theravance ik’ Biopharma A. Medicines That Make a Difference® Thank you Theravance uv Biopharma AY.
Slide 33: 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 34: 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 35: Q&A Session
Theravance ik’ Biopharma A. Medicines That Make a Difference” Q&A Session Theravance uv Biopharma 7’.
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