Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Investor Day (December 2014)
103 slides from Theravance Biopharma's investor day presentation, Dec 12, 2014
Slide 1: Introduction to Theravance Biopharma: Strategic Vision and Differentiation
Rick E Winningham Chairman and Chief Executive Officer Introduction to Theravance Biopharma: Strategic Vision and Differentiation
Slide 2: Today's Agenda
Today’s Agenda Introduction to Theravance Biopharma: Strategic Vision and Differentiation Rick E Winningham Chairman and Chief Executive Officer 9:00-9:20 a.m. VIBATIV® Business Strategy Frank Pasqualone SVP, Operations 9:20-9:35 a.m. Telavancin: A Clinician’s Perspective Louis D. Saravolatz, MD, MA
Slide 3: Safe Harbor Statement
Safe Harbor Statement This presentation contains certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives and future events. Theravance Biopharma intends such fo
Slide 4: Theravance Biopharma Today
Theravance Biopharma Today (NASDAQ: TBPH) Theravance Biopharma was created to drive value from a unique and diverse set of assets A pipeline of high-value assets A productive research platform An approved product A pipeline of high-value assets A productive research platform
Slide 5: Strategic Anchors for Our Business
Strategic Anchors for Our Business Guiding Principles for How We Operate Focus on Insight and Innovation Outsource Non-core Activities Create and Foster an Integrated Environment Aggressively Manage Uncertainty
Slide 6: 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
Slide 7: The Theravance Biopharma Strategy
The Theravance Biopharma Strategy Payors Partners Value Creation Leverage Our Insights to Make a Difference for Patients and Create Meaningful Value for Shareholders
Slide 8: Commercializing Our Products
Optimize commercial potential of products Leverage expertise and geographic reach Mitigate risk Highly focused on pivotal episodes in the patient journey Effective market coverage with specialized resources Infectious disease Lung disease GI disease Other selective areas Meaningful difference for pa
Slide 9: Enhanced Opportunities for Value Creation
Enhanced Opportunities for Value Creation Focus on Infectious Disease, Lung and GI Late-stage Mid-stage Lung GI Tract Infectious Disease / Other TD-4208 (COPD) Closed Triple (COPD) Axelopran (OIC) Axelopran/Opioid FDC VIBATIV: cSSSI HABP/VABP (Bacteremia) MABA (COPD) MABA-ICS (COPD, Asthma) Velusetr
Slide 10: Enhanced Opportunities for Value Creation: Strategic Partnerships
Enhanced Opportunities for Value Creation Strategic Partnerships / Partner Funded Programs Late-stage Mid-stage Lung GI Tract Infectious Disease / Other TD-4208 (COPD) Closed Triple (COPD) Axelopran (OIC) Axelopran/Opioid FDC VIBATIV: cSSSI HABP/VABP (Bacteremia) MABA (COPD) MABA-ICS (COPD, Asthma)
Slide 11: Manage Our Portfolio
Manage Our Portfolio Pipeline Provides Strategic Options Go Alone (U.S. - Acute) Partner Monetize/Divest Determine the appropriate path for each program to optimize program value and allocation of resources
Slide 12: Commercializing Our Products: Focus on VIBATIV
Commercializing Our Products Focus on VIBATIV® Therapeutic Focus: Serious MRSA infections (approved for cSSSI and HABP/VABP, Phase 3 for bacteremia) Product Attributes: Treatment for Gram-positive serious infection across multiple body sites Dual mechanism of action Partnering Strategy: Regional par
Slide 13: Leveraging Our Commercial Infrastructure
Leveraging Our Commercial Infrastructure Developing products initiated or used in and around acute care centers leverages existing commercial infrastructure Strategic commercial partnerships to expand reach will be key in certain specialty markets and outside the U.S. Acute Care Center Opportunities
Slide 14: Focus on TD-4208
Commercializing Our Products Focus on TD-4208 Therapeutic Focus: Respiratory: COPD and other diseases of lung Product Attributes: Potential first-in-class nebulized, once-daily bronchodilator designed to selectively target the lung without significant exposure Compatible with requirements for DPI/MD
Slide 15: Focus on Axelopran and Opioid/Axelopran FDC
Commercializing Our Products Focus on Axelopran and Opioid/Axelopran Fixed Dose Combo Therapeutic Focus: GI: Opioid-induced constipation (OIC) Pain: Fixed-Dose Combo (FDC) with opioid Product Attributes: Potential best-in-class, orally-administered and peripherally selective opioid receptor antagoni
Slide 16: Focus on Velusetrag
Commercializing Our Products Focus on Velusetrag Therapeutic Focus: GI: Gastroparesis Product Attributes: Oral, once-daily highly selective 5-HT4 agonist Accelerated gastric emptying in Phase 2a study Partnering Strategy: Partnered with Alfa Wassermann (AW) for EU, Russia, China and Mexico Rights re
Slide 17: Focus on Closed Triple
Leveraging Monetization/Divestment Focus on Closed Triple Therapeutic Focus: Respiratory: COPD and potentially asthma Product Attributes: Potential first-in-class once-daily closed triple therapy in LABA/LAMA/ICS Triple therapy targeted towards patients with more symptoms and higher exacerbation ris
Slide 18: 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 ICS/LABA COPD sales
Slide 19: The Theravance Biopharma Difference
The Theravance Biopharma Difference † TBPH holds economic interest in future payments that may be made by GlaxoSmithKline plc (GSK) relating to certain programs, including “Closed Triple” (FF/UMEC/VI) (Fluticasone Furoate/Umeclidinium/Vilanterol), MABA/FF (‘081), MABA monotherapy and other future pr
Slide 20: The Theravance Biopharma Strategy
The Theravance Biopharma Strategy Payors Partners Value Creation Leverage Our Insights to Make a Difference for Patients and Create Meaningful Value for Shareholders
Slide 21: VIBATIV Business Strategy
Frank Pasqualone Senior Vice President of Operations VIBATIV® Business Strategy
Slide 22: 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 23: Transforming VIBATIV: Efficient Transition to Acute Care
Transforming VIBATIV Efficient Transition to Acute Care
Slide 24: Potential for Broadest Set of Indications
VIBATIV (*) Complicated or Acute Bacterial Skin or Skin Structure Infection 1Potential for broadest set of indications among branded anti MRSA agents Potential for Broadest Set of Indications1 telavancin ceftaroline dalbavancin daptomycin linezolid oritavancin tedizolid Compound Indications SSSI* HA
Slide 25: Theravance Biopharma Difference: Strategy Science Delivering Value
Theravance Biopharma Difference: Strategy Science Delivering Value Astellas Theravance Biopharma 1st line use in the competitive cSSSI population Position VIBATIV is the preferred anti-MRSA treatment for patients not likely to respond to current S. aureus therapy in approved indications None Develop
Slide 26: Current U.S. Market Opportunities for VIBATIV
Current U.S. Market Opportunities Exist for VIBATIV Among Alternative MRSA Therapies Source: TBPH estimates based on integrating data from multiple sources *Others includes Tygacil and Synercid
Slide 27: VIBATIV Approach: Deliberate and Targeted
VIBATIV Approach SECONDARY Microbiology Hospitalists TERTIARY ER PRIMARY Infectious Disease Critical Care Pulmonology Pharm D Targets Deliberate and Targeted
Slide 28: The Approach Targets Appropriate Patient Populations
The Approach Targets Appropriate Patient Populations 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
Slide 29: Market Research
Market Research Data for bacteremia or osteomyelitis would be welcome since there is an unmet need in those indications Key differentiating benefits of VIBATIV are said to be its activity when vancomycin MICs rise, once daily dosing convenience, and bactericidal action Former users welcome VIBATIV b
Slide 30: The Future: Building the VIBATIV Brand
The Future Multicenter, randomized, open-label, non-inferiority trial in 250 patients For complicated Staphylococcus aureus (SA) bacteremia and SA right-sided infective endocarditis (RIE) Generate medical/scientific publications to address information gaps Over 500 publications* to date Characterize
Slide 31: Building the Global VIBATIV Brand
The Future Theravance Biopharma Partner Presence Ongoing Partner Discussions Hikma Building the Global VIBATIV Brand
Slide 32: Foundation Built on VIBATIV
Theravance Biopharma Difference Foundation Built on VIBATIV VIBATIV: Attractive commercial brand Potential for broadest set of indications1 Strong IP position Market feedback validates brand and commercial strategy Foundation for an acute care business within TBPH with the potential for significant
Slide 33: Telavancin: A Clinician's Perspective
Louis D. Saravolatz, MD, MACP St. John Hospital, Detroit, MI Infectious Disease Specialist Disclosure: Theravance Biopharma Antibiotics Scientific Advisor Full Prescribing Information, including Boxed Warning and Medication Guide in the U.S., is available at www.VIBATIV.com. Telavancin: A Clinician’
Slide 34: The Challenge of MRSA in the United States
The Challenge of MRSA in the United States U.S. Mortality Rates in Infectious Diseases and Other Causes MRSA is responsible for more US deaths annually than many other serious infectious diseases . 60,000 40,000 Infectious agents (selected) Other causes (selected) Estimated Deaths: United States (20
Slide 35: The Challenge of MRSA in the U.S.
The Challenge of MRSA in the U.S. MRSA is an ongoing challenge in the community and hospitals Over 50% of infections caused by Staphylococcus aureus are methicillin-resistant S. aureus (MRSA) MRSA is among the most common hospital-acquired pathogens Serious MRSA infections require prompt and effecti
Slide 36: The Challenge of Serious Infections: Bacterial Pneumonia
The Challenge of Serious Infections: Bacterial Pneumonia Hospital-acquired and Ventilator-associated Bacterial Pneumonia (HABP/VABP) Second most common hospital-acquired infection in the US Up to 27% of all ICU infections are caused by HABP/VABP Results in over 50% of antibiotics prescribed in the I
Slide 37: The Challenge of Treating HABP/VABP
The Challenge of Treating HABP/VABP Significant impact on morbidity, mortality and cost of care MRSA is the most common Gram-positive pathogen in HABP/VABP Early and appropriate therapy is critical In ICU patients, research demonstrated that early, appropriate antimicrobial therapy is associated wit
Slide 38: The Challenge of HABP/VABP due to MRSA Infection
The Challenge of HABP/VABP due to MRSA Infection Higher Vancomycin MICs are Associated with Increased Mortality Haque et al, Chest, 2010, 138:1356-62 Mortality Rates by Vancomycin MIC
Slide 39: Individualization of Care
Individualization of Care Treatment Decisions must be made at the Individual Patient Level
Slide 40: Why Physicians Choose Telavancin
Why Physicians Choose Telavancin 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 resistance ide
Slide 41: Bactericidal Activity against MRSA
Bactericidal Activity against MRSA In Vitro Time-Kill Curves Vancomycin 10 9 8 7 6 5 4 3 2 1 0 0 4 8 12 16 20 24 Log (CFU/mL) Time (hours) Linezolid Telavancin All agents tested at 8x MIC1 for MRSA ATCC 33591 using earlier methodology2 Growth control Pace, AAC, 2003;47(11):3602-3604; CLSI. M7 A9
Slide 42: Telavancin Lung Penetration for Treatment of HABP/VABP
Time (h) 0 5 10 15 20 25 1000 100 10 1 0.1 Telavancin Concentration (µg/mL) Telavancin lung penetration for treatment of HABP/VABP Concentration in Plasma, Alveolar (AM) and Epithelial Lining Fluid (ELF) Mean (±SD) concentrations of telavancin in plasma, AM, and ELF AM Plasma ELF Gotfried MH et al.
Slide 43: Telavancin Cure Rates in HABP/VABP Phase 3 Trials
Telavancin Cure Rates in HABP/VABP Phase 3 Clinical Trials Mean (±SD) concentrations of telavancin in plasma, AM, and ELF VIBATIV® (televancin) Prescribing Information. Theravance Biopharma Antibiotics, Inc. March 2014 Data on File. Theravance Biopharma, Inc. Study Population ATTAIN 1 ATTAIN 2 COMBI
Slide 44: Efficacy in Clinically Relevant HABP/VABP Patient Subgroups
Efficacy in Clinically Relevant HABP/VABP Patient Subgroups . Pooled Clinical Cure Rates by Subgroup 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 R
Slide 45: HABP Patient Successfully Treated with Telavancin
HABP Patient Successfully Treated with Telavancin 57 yo. male smoker readmitted to hospital due to post-operative complications from surgical intervention for wound infection. Prior hospital admission was within prior 3 months (1 week in ICU post-op) and prior antibiotic treatment. Medical history i
Slide 46: HABP Patient Successfully Treated with Telavancin
HABP Patient Successfully Treated with Telavancin 49 yo. male admitted for Shortness of Breath (SOB), dyspnea and fever Medical history includes: urinary retention and renal abscess. Previously treated for MRSA bacteremia and UTI with vancomycin and daptomycin. T = 101.6; CrCL = 75mL/min, WBC = 13.6
Slide 47: Effective Treatment for Serious Infections Is Critical
Effective Treatment for Serious Infections, including HABP/VABP due to MRSA, is Critical For the public health Increasing incidence and severity of MRSA infections Increasing burden of HABP/VABP due to MRSA Moving Target: Continuing evolution of drug resistance For individual patients When vancomyci
Slide 48: VIBATIV Important Safety Information (U.S.)
VIBATIV® (telavancin) for injection Important Safety Information (U.S.) Full Prescribing Information, including Boxed Warning and Medication Gide in the U.S., is available at www.VIBATIV.com. VIBATIV® is a registered trademark of the Theravance Biopharma group of companies.
Slide 49: Q&A Session #1
Theravance i’ Biopharma AK. Medicines That Make a Difference” Q&A Session #1
Slide 50: Break
Theravance i Biopharma AK. Medicines That Make a Difference” Break
Slide 51: TD-4208: Nebulized LAMA for COPD
Brett Haumann, MD, MBA Senior Vice President, Development and Operations TD-4208: Nebulized LAMA for COPD
Slide 52: TD-4208 Addresses the Unmet Need for a Nebulized LAMA
TD-4208 aims to address the unmet need for a standard of care nebulized LAMA Unmet Need: Once-daily LAMAs are first-line therapy for moderate to severe COPD1 43% of COPD treatment regimens in U.S. include a LAMA2 LAMAs are only available in handheld devices Compelling Market Opportunity: 9% of COPD
Slide 53: 9% of Treated COPD Patients Use Nebulized Therapy
Despite limited options, 9% of treated COPD patients in the U.S. use nebulized therapy on an enduring basis1 This is in the absence of any nebulized LAMAs 1TBPH market research (N = 160 physicians) 2© 2014 DR/Decision Resources, LLC. All rights reserved. This data is provided for informational purpo
Slide 54: Physicians Identify Patients Appropriate for Nebulizer Therapy
Physicians readily identify those patients who are most appropriate for nebulizer therapy Based on disease severity, patient preference & functional status % of Physicians Ranking in Top 3 1TBPH market research (N = 160 physicians)
Slide 55: Limited Options for COPD Patients Using Nebulized Bronchodilators
There are limited options for COPD patients who use nebulized bronchodilators 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
Slide 56: Nebulized Twice-Daily LABA Market Sales
The nebulized twice-daily LABA market has sales approaching $400M annually in U.S.1 Growth seen despite generic short-acting bronchodilators, restricted tier status and not being the gold standard LAMA Sales CAGR: 26% 1Estimate derived from the use of information under license from the following IMS
Slide 57: TD-4208 Improves Lung Function in COPD Patients
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 58: TD-4208 Shows Sustained 24-Hour Duration of Action
TD-4208 shows a sustained 24-hour duration of action following once-daily dosing Effects are maintained throughout 4-week dosing period Placebo-adjusted change from baseline in FEV1 on Day 28 0 50 100 150 200 250 PD 1 2 3 4 6 8 10 12 15 21 23.75 Time point (hours) Adjusted LS Mean FEV1 Change from B
Slide 59: The Regulatory Path Is Clear and Well-Precedented
The regulatory path is clear and well-precedented FDA has confirmed that TD-4208 can progress to Phase 3 studies Phase 3 program matches previous LAMA programs: 2 replicate 3-month efficacy studies Single 12-month safety study FDA meeting held December 8th Agreement on once-daily dosing Agreement on
Slide 60: Nebulized Therapy in Hospitalized COPD Exacerbation
Nebulized therapy may be initiated in patients hospitalized with an acute COPD exacerbation COPD is responsible for 800,000 U.S. hospitalizations annually1 1Wier et al; HCUP Statistical Brief #106; Agency for Health Care Policy and Research, 2011 2TBPH market research (N = 160 physicians)
Slide 61: TD-4208 Potential Nebulized Bronchodilator of Choice
TD-4208 has the potential to become the nebulized bronchodilator of choice in COPD Aims to become the standard of care in the nebulized space Complements existing nebulized LABA treatment options Provides sustained bronchodilation over 24 hours Offers the convenience of once-daily dosing via jet neb
Slide 62: Axelopran: Oral PAMORA for Opioid-Induced Constipation
Brett Haumann, MD, MBA Senior Vice President, Development and Operations Axelopran: Oral PAMORA for Opioid-Induced Constipation
Slide 63: Axelopran Aims to Offer a Differentiated Product
Axelopran aims to offer a differentiated product Treatment class is evolving: PAMORAs offer targeted peripheral efficacy without altering central analgesia Regulatory path to approval has been clarified Recent product approvals will help build the market Patient need exists: Over the counter laxativ
Slide 64: OIC Limits Effective Pain Management
OIC limits effective pain management OIC results in frequent adjustments to analgesic therapy FREQUENCY OF ALTERING PAIN MEDICATION TO MANAGE CONSTIPATION1 - Patients and HCPs - % of Remaining Patients Whose Dose is Changed % of Patients for Whom HCPs Change Opioid 1TBPH patient (N=386) and HCP (N=5
Slide 65: Health Care Professionals Not Satisfied with Current Options
Health care professionals are not satisfied with current treatment options HCP ATTITUDES REGARDING OIC TREATMENTS1 - % Top 3 Box - Agreement rated on a scale from 1 to 10 where 1 means “Disagree Completely” and 10 means “Agree Completely”: I would value new therapy that allowed patients to return to
Slide 66: Sizable, Symptomatic and Dissatisfied U.S. Patient Population
There is a sizable, symptomatic and dissatisfied patient population in the U.S.1 U.S. patients using chronic opioids (>1 episode of >90 days per year) Patients reporting constipation due to opioids Candidates for axelopran therapy (Used OTC laxatives, have discussed OIC with physician, and have drug
Slide 67: OIC Patients Are Readily Accessible
The population of OIC patients is readily accessible and not satisfied with current treatment options OIC patients are already in the healthcare system and visit physicians who prescribe their scheduled opioids every month Patients report discussing OIC with HCPs an average of 4.4 times per year1 Pa
Slide 68: Well Placed to Access Patients in Changing Prescribing Environment
Theravance Biopharma is well placed to access suitable patients within a changing prescribing environment CDC Mortality and Morbidity Weekly Report July 1st 2014: http://www.cdc.gov/mmwr/pdf/wk/mm63e0701a2.pdf Legislative changes are driving a shift in opioid prescribing from primary care to pain sp
Slide 69: Axelopran Development Program Focused on Differentiation
The axelopran development program is focused on differentiation Axelopran aims to: Improve bowel function better than the competition Restore normal bowel function Address patient symptoms
Slide 70: Axelopran Phase 2 Data Shows Potential for Differentiation
Axelopran Phase 2 data shows potential for differentiation Improvements in Spontaneous Bowel Movements (SBM) are the current benchmark KODIAK-04 Study Phase 3 axelopran study will include an evaluation comparable to that done for MOVANTIK in Phase 3, including an increase of >1 SBM/week for at least
Slide 71: Study 0084: Rapid Restoration of Normal Bowel Function
Study 0084 Rapid restoration of normal bowel function followed by maintenance Patients consider >5 SBM/week a return toward normal bowel function
Slide 72: Increased Frequency of Complete Spontaneous Bowel Movements
Increased frequency of Complete Spontaneous Bowel Movements (CSBM) Provides a more rigorous assessment of return to normal function p=0.0010 p=0.0003
Slide 73: Improvement in Gastrointestinal Symptoms
Improvement in gastrointestinal symptoms Suggests potential for differentiation on patient-reported symptoms Gastrointestinal-related Symptom Domain Abdominal pain Bloating Need to have a bowel movement but cannot
Slide 74: Patients Need Symptom Relief Beyond Normalizing Bowel Function
Patients need symptom relief beyond normalizing bowel function Increasing SBM alone does not address patients’ needs 1TBPH patient (N=386) market research
Slide 75: 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 Enabled
Slide 76: Axelopran Does Not Alter Systemic Oxycodone Exposure in FDC
Axelopran does not alter systemic exposure to oxycodone when delivered as a fixed dose combination (spray-coating) Fixed dose combination Oxycontin plus axelopran Oxycodone Relative Bioavailability to Reference (Reference = OxyContin Alone) Relative Bioavailability 50 150 AUC 0- ¥ AUC 0-last C max A
Slide 77: Axelopran Aims to Be the Treatment of Choice for OIC
Axelopran aims to be the treatment of choice for OIC Targeted approach to address OIC effectively, in contrast to laxatives Large, well-defined, accessible patient population Increasingly managed by pain specialists, aligned with TBPH focus on specialty business Clear regulatory pathway and FDA alig
Slide 78: Research and Development: Evolution of Insight and Approach
Mathai Mammen, MD, PhD Senior Vice President, Research and Development Research and Development Evolution of Insight and Approach
Slide 79: Evolution of Insight at Theravance Biopharma
Evolution of Insight at Theravance Biopharma Axelopran OIC Telavancin Bacteremia TD-4208 COPD Late Stage Early Stage Research TD-6450 HCV ARNI Heart Failure Localized Medicine for Localized Disease Lung GI Multivalent Design to Medicines
Slide 80: Multivalent Design at Theravance Biopharma
Multivalent Design at Theravance Biopharma Examples of Differentiating Features Clinical Benefit Axelopran (TD-1211) m-opioid antagonist Opioid Induced Constipation VIBATIV® Gram-positive antibacterial cSSSI & HABP/VABP TD-4208 Inhaled LAMA COPD Dual Pharmacology Controlled Distribution Receptor and
Slide 81: High Potential Early Stage Programs
Evolution of Insight at Theravance Biopharma Axelopran OIC Telavancin Bacteremia TD-4208 COPD Late Stage Early Stage Research TD-6450 HCV ARNI Heart Failure Localized Medicine for Localized Disease Lung GI High Potential Early Stage Programs
Slide 82: TD-6450: Multivalent NS5a Inhibitor Viral Load Decline
TD-6450: Multivalent NS5a Inhibitor: Greatest Reported GT-1a Viral Load Decline after Three Doses Phase 1b: Genotype 1a Patients TD-6450 MK-8742 GS-5816 ACH-3102 IDX-719 Mean Reduction HCV GT-1a RNA (log10 IU/mL) -5.00 -4.17 -3.56 -3.78 -3.50 Non-symmetric structure permits distinct binding mode TD-
Slide 83: TD-6450 Granted Fast Track Designation
TD-6450: Multivalent NS5a Inhibitor: Greatest Reported GT-1a Viral Load Decline after Three Doses Phase 1b: Genotype 1a Patients TD-6450 MK-8742 GS-5816 ACH-3102 IDX-719 Mean Reduction HCV GT-1a RNA (log10 IU/mL) -5.00 -4.17 -3.56 -3.78 -3.50 Non-symmetric structure permits distinct binding mode TD-
Slide 84: ARNI Class May Be a Paradigm Shift for Heart Failure
ARNI Class of Medicines May be a Paradigm Shift for Patients with Congestive Heart Failure However, important considerations: Inflexible 1:1 valsartan:sacubitril Excluded patients with severe renal dysfunction (~ 1M patients)3 Symptomatic Hypotension 1McMurray et al (2014) N Engl J Med, 371:993-1004
Slide 85: Objective: Best-in-Class ARNI for Heart Failure
Our Objective is to Create a Best-in-Class ARNI for Heart Failure Best NEPi Best ARB + Sustained Ang II Receptor Blockade in Preclinical Model = Best ARNI Improved efficacy All HF patients QD dosing Sustained Neprilysin Inhibition in Preclinical Model Value Inflection in Phase 1b / 2a Time (hr) % In
Slide 86: Objective: Best-in-Class ARNI for Heart Failure
Our Objective is to Create a Best-in-Class ARNI for Heart Failure Best NEPi Best ARB + Sustained Ang II Receptor Blockade in Preclinical Model = Best ARNI Improved efficacy All HF patients QD dosing Sustained Neprilysin Inhibition in Preclinical Model Go Alone (U.S. - Acute) Partner Monetize/Divest
Slide 87: 15+ Years of Learning Led to Research Strategy
Evolution of Insight at Theravance Biopharma Axelopran OIC Telavancin Bacteremia TD-4208 COPD Late Stage Early Stage Research TD-6450 HCV ARNI Heart Failure Localized Medicine for Localized Disease Lung GI 15+ Years of Learning Led to Research Strategy Goal of localization is enhanced efficacy in ta
Slide 88: Insights Evolved Over 15 Years Along Three Dimensions
Multiple Successful P2 Studies Expertise in: Smooth Muscle Biology and Immuno-Inflammation Disease Insights Lung and GI Disease Biological and Chemical Research Insights Evolved Over 15 Years Along Three Dimensions Inhaled Medicines by Design “Design-in” Tissue Kinetics, Dynamics and Systemic Cleara
Slide 89: Localized Medicines for Localized Diseases
Localized Medicines for Localized Diseases Leveraging Multivalent Design to Treat Severe Immuno-inflammatory Diseases of Lung and GI Tract
Slide 90: Control Is Significant Challenge for Severe Asthma
Control is Significant Challenge for Severe Asthma ~ 2M asthmatics (U.S. + EU) refractory to high-dose bronchodilator/ICS therapy1 10-15% patients account for ~50% of asthma budget2 Small subgroups benefit from Biologics Asthma is a complex, heterogeneous disease and inhibition of multiple mediators
Slide 91: Broadly Active Inhaled JAK Inhibitors for Severe Asthma
We are Creating Broadly Active Inhaled Inhibitors of JAK as Powerful Potential Treatment for Severe Asthma Potential applications beyond severe asthma Low risk Localized Drug Targeted Benefit High Impact BALF eosinophils Control JAK inhibitor Rodent Lung Inflammation Lung Plasma Time (h) 300x [JAK I
Slide 92: 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 93: Oral GI-Restricted Small Molecules for Ulcerative Colitis
We are Creating Oral Small Molecules for Ulcerative Colitis that are Restricted to the GI Tract Low risk High Impact Localized Drug Targeted Benefit Systemically-active agent TBPH compound Potential applications beyond UC Low dose Healthy Control High dose Rodent GI Inflammation Rodent Pharmacokinet
Slide 94: Evolution of Insight: High Potential Early and Late Stage Programs
Evolution of Insight at Theravance Biopharma We make highly impactful medicines based on our experience and our understanding of patient needs Today’s Research leverages 15+ years of evolution of insight Multiple programs poised to deliver value in the near and medium term Axelopran OIC Telavancin B
Slide 95: Financial Highlights and Outlook
Renee Gala Chief Financial Officer Financial Highlights and Outlook
Slide 96: Financial Highlights and Outlook
Financial Highlights and Outlook Financial Management of the Business Investment Focus for 2015 2015 Financial Guidance
Slide 97: Financial Management Starts with Focus on Insight and Innovation
Financial Management of Business Starts with a Focus on Insight and Innovation Objective of Tax Efficient Corporate Structure is to Optimize Future Cashflows Insight & Innovation Separation Ex-U.S. Domicile
Slide 98: Integration of Finance within the Business
Financial Management of Business Integration of Finance within the Business Prioritize and Optimize Program Investments Reduce Financial Risk to Company Financial Management of the Business Applying Insight and Innovation to Financial Operations
Slide 99: VIBATIV and TD-4208 Drive Investments in 2015
VIBATIV® and TD-4208 Drive Investments in 2015 VIBATIV® Commercial Infrastructure Initiation of Two Phase 3 Programs Research Programs Investment Focus for 2015 Investments in Other Programs Depend on Multiple Factors
Slide 100: 2015 Financial Guidance
2015 Financial Guidance Operating Loss: $150 – 160M † Excluding stock-based compensation Likely to be front-loaded VIBATIV® net sales of approximately $20M Factors that May Impact Guidance: Partnering Data and other program-related decisions Financial Guidance May be Impacted by Partnering and Other
Slide 101: The Theravance Biopharma Strategy
The Theravance Biopharma Strategy Payors Partners Value Creation Leverage Our Insights to Make a Difference for Patients and Create Meaningful Value for Shareholders Insight and Innovation Important in Everything We Do
Slide 102: Q&A Session #2
Theravance i Biopharma AK. Medicines That Make a Difference” Q&A Session #2
Slide 103: Thank You
Theravance ik’ Biopharma AK. Medicines That Make a Difference” Thank You