Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Investor Presentation (September 2016)
47 slides from Theravance Biopharma's investor presentation, Sep 7, 2016
Slide 1: 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 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: Pipeline programs and 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 NE
Slide 4: JAK Inhibitor Program
JAK Inhibitor Program Oral Intestinally Restricted Pan-Janus Kinase (JAK) Inhibitors for Ulcerative Colitis & Other Inflammatory Intestinal Diseases
Slide 5: Significant Need Remains for Improved Therapies for Ulcerative Colitis
Oral Small Molecule Intravenous Biologic ~700K UC patients in the US, according to www.ccfa.org 1 D.T. Beattie, et al., TD-1473, a novel, potent, orally administered intestinally restricted pan-Janus kinase (JAK) inhibitor. Poster session presented at: 11th Congress of the European Crohn's and Colit
Slide 6: TD-1473: Oral, Intestinally Restricted JAK Inhibitor
TD-1473: Oral, Intestinally Restricted JAK Inhibitor with the Potential for Robust Efficacy and Minimal Side Effects Based on preclinical findings TD-1473 may represent a potential breakthrough approach to treating UC without the risk generally associated with systemically active therapies TD-1473 E
Slide 7: TD-1473: Phase 1 Clinical Data Support Progression into Phase 1b
TD-1473: Phase 1 Clinical Data Support Progression into Phase 1b Trial in Ulcerative Colitis Patients Clinical and preclinical data validate strategy of targeting JAK inhibition to affected tissues in the intestinal tract to achieve favorable risk/benefit profile Multiple Ascending Dose PK on Day 14
Slide 8: TD-1473: Phase 1b Study in Ulcerative Colitis Patients
TD-1473: Phase 1b Study in Moderately-to-Severely Active Ulcerative Colitis Patients to Initiate in 2016 Designed to evaluate safety, tolerability, PK and PD of TD-1473 in moderately to severely active ulcerative colitis patients over 28 days Secondary/exploratory objective: demonstrate biologic eff
Slide 9: TD-3504: Prodrug of Tofacitinib
TD-3504: Innovative Prodrug of Tofacitinib Provides Alternative Strategy to Achieve Intestinally Restricted JAK Inhibition Superior Therapeutic Index Compared to Tofacitinib in Preclinical Oxazolone Colitis Model Preclinical data for TD-3504 showed: Rapid formation of tofacitinib in intestinal tract
Slide 10: Neprilysin Inhibitor (NEPi) Program
Neprilysin Inhibitor (NEPi) Program Potential Best-in-Class Therapeutic for Cardiovascular and Renal Disease
Slide 11: Best-in-Class NEPi Could Improve Treatment Regimens
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 12: TBPH NEPi Program: Differentiated and Versatile Platform
TBPH NEPi Program: Differentiated & Versatile Platform with Multiple Development Candidates Advancing Range of Cardiovascular and Renal Indications TBPH NEP Inhibitor Target Product Profile Sustained 24-hour target engagement Non-renal clearance Favorable safety and tolerability Flexible administrat
Slide 13: Revefenacin (TD-4208)
Revefenacin (TD-4208) Nebulized Long-Acting Muscarinic Antagonist (LAMA)
Slide 14: 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 15: Revefenacin 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 16: Significant funding from Mylan collaboration
Significant funding for Theravance Biopharma (TBPH) $15M initial payment to TBPH Up to $220M in development and commercialization milestones Reimbursement of US development program expenses* $30M equity investment at a 10% premium Profit share in US and low to mid-teen double-digit royalties ex-US T
Slide 17: VIBATIV (telavancin)
VIBATIV® is a registered trademark of the Theravance Biopharma group of companies VIBATIV® (telavancin) Commercial, Once-Daily, Dual Mechanism Antibiotic
Slide 18: 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 19: Opportunity 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 IMS Health National Sales Perspective and Decision Resources Hospital Antibiotic Market Guide *Others includes Tygacil and Synercid (2014) 79% 21% Total Days
Slide 20: VIBATIV Commercialization
VIBATIV® Commercialization 1Total Factored Vials = 750mg vials + (250mg vials/3); Source: Symphony Health Solutions, NonRetailSourceTM , January 2015 – March 2016, based on Theravance factored vials. 2 TBPH Market Research Acute Care Focused Sales Force in Hospitals and Outpatient Centers Physicians
Slide 21: VIBATIV: Label Expansion Strategy
VIBATIV®: Label Expansion Strategy 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 anal
Slide 22: Theravance Biopharma Opportunities for Value Creation
Theravance Biopharma Opportunities for Value Creation
Slide 23: Economic Interest in GSK Respiratory Programs
Economic Interest in GSK Respiratory Programs *TBPH holds economic interest in future payments that may be made by GSK relating to certain programs, including “Closed Triple” (FF/UMEC/VI), MABA/FF, MABA monotherapy and other future products that may be combined with VI or MABA. All statements based
Slide 24: Expected Key Milestones
Expected Key Milestones Program Milestone Target TD-1473 (JAK inhibitor) Complete Phase 1 2016 TD-1473 (JAK inhibitor) Complete Phase 1b Study in UC Patients 2017 TD-0714 (NEP inhibitor) Complete Phase 1 (incl. target engagement) 2016 Revefenacin (TD-4208) Complete Phase 3 Efficacy Studies 2016 Reve
Slide 25: 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 26: 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 27: VIBATIV 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 28: VIBATIV Important Safety Information (US)
VIBATIV® (telavancin) Important Safety Information (US) Mortality Patents wih pre-exsting moderatelsevere renal impairment (CrC 50 mLimi) who were Weoed with VIBATIV® fr hospts-acquired bacterial paumoniventlatr-associted Dactral pneumonia had increased morally served versus vancomycin. Use of VIBAT
Slide 29: Back-Up
Theravance ik’ Biopharma A. Medicines That Make a Difference” Back-Up jeravance Kt Biopharma 7”.
Slide 30: Optimizing Pipeline Value by Leveraging Partnerships and Commercial Infrastructure
Optimizing Pipeline Value by Leveraging Partnerships and Commercial Infrastructure Late-stage=Regulatory submission filed, P3 development, P3-ready; Mid-stage=between P1 and P2b; Early-stage=pre-clinical; 1Data added to label for approved indications (cSSSI & HABP/VABP); 2TBPH holds economic interes
Slide 31: Optimizing Pipeline Value by Leveraging Partnerships and Commercial Infrastructure
Optimizing Pipeline Value by Leveraging Partnerships and Commercial Infrastructure Program eerie Collaborator Marketed VIBATIV® (telavancin) eae Multiple Partners SSSI, HABP/VABP, Concurrent Bacteremia’ dead (ous) Telavancin Multiple Partners Bacteramia Aniinfecive (eUS) Revefenacin (TD-4208) COPD &
Slide 32: 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 33: Patient Need Driving Utilization
Patient Need Driving Utilization Taking SSRI’s Immunocompromised patients HABP/VABP in institutions with vancomycin MICs>1µg/mL HABP/VABP patients with comorbidities Requiring >7 days of therapy Patients with persistent or recurrent infection OPAT*– given convenience of QD dosing When a bactericidal
Slide 34: Phase 3 HABP/VABP Clinical Trial Results
Phase 3 HABP/VABP Clinical Trial Results Microbiologically Evaluable (ME) TLV % Cure VAN % Cure % Difference (TLV – VAN; 95% CI) Single Gram-positive (only) 84.0 (147/175) 75.9 (132/174) 8.1 (-0.2%, 16.5%) MRSA (only) 80.2 (73/91) 74.1 (86/116) 6.1 (-5.3%, 17.5%) S. aureus with VAN MIC 1 μg/mL 85.7
Slide 35: Activity in Clinically Relevant HABP/VABP Subgroups
Activity in Clinically Relevant HABP/VABP Subgroups Pooled Clinical Cure Rates in Phase 3 Trials (CE population) 95% CI -1.0%, 28.3% 95% CI -4.0%, 13.4% 95% CI -7.9%, 47.5% 95% CI -11.5%, 36.5% 95% CI -9.4%, 27.5% 56/70 43/65 17/20 18/26 125/155 146/192 24/32 8/15 36/53 33/58 Rubinstein, Crit Care C
Slide 36: VIBATIV: Potential for Broadest Set of Indications Among Branded Anti-MRSA Agents
VIBATIV®: Potential for Broadest Set of Indications Among Branded Anti-MRSA Agents 1Complicated or Acute Bacterial Skin or Skin Structure Infection 2Approved for use in acute bacterial skin and skin structure infections with baseline S. aureus bacteremia telavancin ceftaroline2 dalbavancin daptomyci
Slide 37: VIBATIV: Potential for Broadest Set of Indications Among Branded Anti-MRSA Agents
VIBATIV®: Potential for Broadest Set of Indications Among Branded Anti-MRSA Agents Primary Indication Compound sssi' HABP/VABP Bacteremia telavancin S S Registrational Study ceftaroline? a dalbavancin Y daptomycin v v oritavancin v tedizolid A Theravance uv Biopharma A
Slide 38: 9% of Treated COPD Patients in the U.S. Use Nebulized Therapy
Despite Limited Options, 9% of Treated COPD Patients in the U.S. Use Nebulized Therapy on Enduring Basis1 1TBPH market research (N = 160 physicians); 2© 2014 DR/Decision Resources, LLC. All rights reserved. This data is provided for informational purposes only and is not intended to, and does not, c
Slide 39: Physicians Readily Identify Patients Appropriate for Nebulizer Therapy
Physicians Readily Identify Patients Appropriate for Nebulizer Therapy % of Time Physicians Ranked as Top 3 Characteristic 1TBPH market research (N = 160 physicians) Characteristics of Patients Suitable for Nebulizer Therapy 73% 57% 51% 30% 28% 19% 0% 100% Severe/very severe COPD Patients prefer neb
Slide 40: 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 41: Revefenacin Showed Sustained 24-hour Duration of Action
Revefenacin (TD-4208) Showed Sustained 24-hour Duration of Action Following Once-daily Dosing Effects Maintained throughout 4-week Dosing Period Placebo-adjusted change from baseline in FEV1 on Day 28 Source: Phase 2 once- versus twice-daily (QD versus BID) study of TD-4208 0 50 100 150 200 250 PD 1
Slide 42: Revefenacin Showed Sustained 24-hour Duration of Action
Revefenacin (TD-4208) Showed Sustained 24-hour Duration of Action Following Once-daily Dosing Effects Maintained throughout 4-week Dosing Period Adjusted LS Mean FEV1 Change from Baseline (mL) y g 8 L TD-4208 Treatment Groups = 44mog —* 175 mog —* 88 meg —- 350 meg a 8 L 3 8 L a 8 1 ° Time point (ho
Slide 43: Axelopran Aims to Offer a Differentiated Product
Axelopran Aims to Offer a Differentiated Product 1. Pappagallo et al. American J of Surgery 182 (Suppl) Nov 2001, 11S-18S Once-daily Oral PAMORA for Opioid-Induced Constipation Evolving Treatment Class PAMORAs offer targeted peripheral efficacy without altering central analgesia Regulatory path to a
Slide 44: Commercial Potential for Opioid/Axelopran Fixed Dose Combinations
Substantial Commercial Potential for Opioid/ Axelopran Fixed Dose Combinations (FDC) FDC offers the opportunity for pain relief without constipation in a single abuse-deterrant pill Could represent a paradigm shift in opioid treatment TBPH has developed a proprietary spray-coating formulation Enable
Slide 45: Study of Axelopran Fixed-Dose Combination and Controlled-Release Oxycodone
Phase 1 Study of Axelopran Fixed-Dose Combination (FDC) and Controlled-Release Oxycodone Fixed dose combination Oxycontin plus axelopran Axelopran Did Not Significantly Alter Systemic Exposure to OxyContin® When Delivered as a FDC Relative vs. Co-Administered as Individual Tablets Oxycodone Relative
Slide 46: Economic Interest in GSK Respiratory Programs
Economic Interest in GSK Respiratory Programs Opportunity for “Triple Therapy” “Closed Triple” (FF/UMEC/VI): Upward-tiering royalty 6.5% - 10% of annual global net sales MABA Monotherapy (batefenterol): 10% to 20% of annual global net sales up to $3.5 billion, and 7.5% for all annual global net sale
Slide 47: Economic Interest in GSK Respiratory Programs
Economic Interest in GSK Respiratory Programs Opportunity for “Triple Therapy” 85% Economic Interest! in Future Payments Made by GS' Certain Potential Respiratory Products, including “Closed Triple” (FF/UMEC/VI): Upward-tiering royalty 6.5% - 10% of annual global net sales MABA Monotherapy (batefent
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