Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Investor Presentation (January 2017)
28 slides from Theravance Biopharma's investor presentation, Jan 9, 2017
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 1 $289.3M in cash, cash equivalents, and marketable securities as of 9/30/16, excluding $22.7M in receivables from collaborative arrangements as of 9/30/16 and $330.3M in net proceeds from financing in Q4. Productive Research Engine Validated in Multiple Di
Slide 3: Upcoming Milestones
Upcoming Milestones Program Milestone Target TD-1439 (NEP inhibitor) Phase 1 SAD/MAD results 1H 2017 TD-1473 (JAK inhibitor) Phase 1b results in UC patients Mid 2017 TD-9855 (NSRI) Phase 2a results in nOH patients Mid 2017 Velusetrag (TD-5108) Phase 2b results in Gastroparesis patients Mid 2017 Reve
Slide 4: JAK Inhibitor Program
JAK Inhibitor Program Oral intestinally restricted pan-janus kinase (JAK) inhibitors for ulcerative colitis and other inflammatory intestinal diseases
Slide 5: Intestinally Restricted JAK Program: Potential Breakthrough Approach to Treating IBD
1 Tofacitinib (Xeljanz®) - an oral, systemically available, JAK inhibitor, which has demonstrated efficacy in treating moderate to severe ulcerative colitis patients. Estimated to be 900K cases of ulcerative colitis in 2017 in the US. Source: Ulcerative Colitis Epidemiology, November 2016 Intestinal
Slide 6: Efficacy of tofacitinib in rodent colitis model driven by local exposure in the colon
Efficacy of tofacitinib in rodent colitis model driven by local exposure in the colon1 Intracecal (direct to colon) delivery (IC) versus oral delivery (PO) of tofacitinib2: IC results in equivalent efficacy of PO, with 15-fold lower dose, similar colon concentration, and 80-fold lower plasma concent
Slide 7: TD-1473: Designed to Maximize Local Anti-Inflammatory Efficacy and Minimize Systemic Exposure
TD-1473: Designed to Maximize Local Anti-Inflammatory Efficacy and Minimize Systemic Exposure 1 Shen et al. Colon Targeted Delivery of Tofacitinib Inhibits Oxazolone-induced Colitis in Mice, Despite Low Systemic Exposure. European Crohn’s and Colitis Organisation Conference, March 2016 Preclinical f
Slide 8: TD-1473: Phase 1b Study in Ulcerative Colitis Patients Underway
Phase 1 SAD/MAD study of TD-1473 in healthy subjects met objectives Data suggest slow absorption of TD-1473 throughout intestinal tract Minimal levels of TD-1473 in systemic circulation High levels of TD-1473 in stool1 Well tolerated at all dose levels Phase 1b designed to evaluate safety, tolerabil
Slide 9: TD-9855 NSRI for neurogenic orthostatic hypotension
TD-9855 Dual norepinephrine and serotonin reuptake inhibitor (NSRI) for neurogenic orthostatic hypotension (nOH)
Slide 10: nOH Represents a Significant Unmet Need
Neurogenic Orthostatic Hypotension (nOH) Represents a Significant Unmet Need 1 Current approved therapies used in treatment of OH include midodrine, fludrocortisone, Northera (droxidopa), nOH is characterized by a sustained drop in blood pressure that occurs upon standing up and is associated with t
Slide 11: Current Approved Therapies in nOH Have Limitations
Current Approved Therapies in Neurogenic Orthostatic Hypotension (nOH) Have Limitations 1 Associated with one or both therapies noted above Successful nOH therapy would target reduction in symptoms and offer meaningful improvements in quality of life for patients Current therapies limited in safety,
Slide 12: Reasons to Pursue TD-9855 in nOH
Reasons to Pursue TD-9855 in nOH Designed to restore deficits in noradrenergic function Norepinephrine dominance confirmed in human PET study1 QD dosing and long half-life may offer improved patient outcomes ADME studies suggest low probability of DDIs Favorable safety and tolerability profile estab
Slide 13: Velusetrag (TD-5108)
Velusetrag (TD-5108) Highly selective 5-HT4 agonist for gastroparesis
Slide 14: Velusetrag has Demonstrated Gastrointestinal Motility Effect with Favorable Safety Profile
Multiple positive Phase 2a studies completed (chronic constipation and gastroparesis) Long term toxicity studies completed Well-tolerated in >600 subjects exposed Velusetrag has Demonstrated Gastrointestinal Motility Effect with Favorable Safety Profile 1 Rey et al., Prevalence of Hidden Gastropares
Slide 15: Neprilysin Inhibitor (NEPi) Program
Neprilysin Inhibitor (NEPi) Program Potential Best-in-Class Therapeutic for Cardiovascular and Renal Disease
Slide 16: 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 17: NEPi Program: Differentiated & Versatile Platform with Multiple Development Candidates
NEPi Program: Differentiated & Versatile Platform with Multiple Development Candidates Advancing Range of Cardiovascular and Renal Indications Theravance NEP Inhibitor Target Product Profile Sustained 24-hour target engagement Non-renal clearance Favorable safety and tolerability Flexible administra
Slide 18: Late Stage & Commercial Assets, Acute Care
Late Stage & Commercial Assets, Acute Care Revefenacin (TD-4208): Nebulized Long-Acting Muscarinic Antagonist (LAMA) VIBATIV® (telavancin): Commercial, Once-Daily, Dual Mechanism Antibiotic
Slide 19: 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 20: Revefenacin: Pivotal Phase 3 Studies Met Primary Endpoints
* P < 0.0001 versus placebo ** P <0.001 versus placebo * ** * * * ** Revefenacin: Pivotal Phase 3 Studies Met Primary Endpoints; Long-term Safety Study Underway Primary endpoint achieved for both doses in both replicate efficacy studies Robust and sustained improvements in FEV1 Effective as monother
Slide 21: VIBATIV: Opportunity Among Alternative MRSA Therapies in Current US Market
VIBATIV®: Opportunity Exists Among Alternative MRSA Therapies in Current US Market Source: TBPH estimates based on integrating data from IMS Health National Sales Perspective and Decision Resources Hospital Antibiotic Market Guide 1Total Factored Vials = 750mg vials + (250mg vials/3); Source: Sympho
Slide 22: VIBATIV Label Expansion and Complementary Products
VIBATIV® Label Expansion and Complementary Products to Optimize Acute Care Organization Opportunity for Broadest Set of Indications of Any Branded Anti-MRSA Agent Acute Care Commercial Focus Phase 3 Registrational Study in Bacteremia ~250 patients in ~70 sites in US & ROW Expected to complete in 201
Slide 23: Opportunities for Value Creation
Opportunities for Value Creation Economic Interests and Full Pipeline Summary
Slide 24: Economic Interest in GSK Respiratory Programs
Economic Interest in GSK Respiratory Programs Royalties from Closed Triple Expected as Early as 2018 1 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 tha
Slide 25: Upcoming Milestones
Upcoming Milestones Program Milestone Target TD-1439 (NEP inhibitor) Phase 1 SAD/MAD results 1H 2017 TD-1473 (JAK inhibitor) Phase 1b results in UC patients Mid 2017 TD-9855 (NSRI) Phase 2a results in nOH patients Mid 2017 Velusetrag (TD-5108) Phase 2b results in Gastroparesis patients Mid 2017 Reve
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 (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 28: VIBATIV (telavancin) Important Safety Information (US)
VIBATIV® (telavancin) Important Safety Information (US) Mortality Patents wth pre-existing moderatelsevere renal imparment (CrCl <50 mL/min) who were treated wih VIBATIV® fer hospital acquired bacterial pneumoniavventlator associated Dacteral pneumonia had inreased moray observed verus vancomycin. U
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