Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Investor Presentation (August 2017)
29 slides from Theravance Biopharma's investor presentation, Aug 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 $498.3M in cash, cash equivalents, and marketable securities as of 6/30/17. Productive Research Engine Validated in Multiple Disease Areas Pipeline Internally-Discovered High Value Assets Robust Business Model Unlocking Near- and Long-term Value Managemen
Slide 3: Upcoming Milestones
Upcoming Milestones Program Milestone Target TD-1439 (NEP inhibitor) Phase 1a SAD/MAD results in healthy volunteers Completed Revefenacin (TD-4208) Phase 3 long-term safety results in COPD patients Completed Velusetrag (TD-5108) Phase 2b results in Gastroparesis patients Completed TD-1473 (JAK inhib
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 Represents a 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: 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 Preclinical findings indicate potential breakthrough approach in UC Selective distribution of TD-1473 to tissues in the GI tract, with reduction in UC disease activity score comparable to systemically deliv
Slide 7: TD-1473: Phase 1 Clinical Data Support Progression into Phase 1b Trial
TD-1473: Phase 1 Clinical Data Support Progression into Phase 1b Trial in Ulcerative Colitis Patients Multiple Ascending Dose PK on Day 14 Log Scale Mean ± SD plotted Multiple Ascending Dose PK on Day 14 Linear Scale 1 Stool concentrations of TD-1473 were comparable to concentrations associated with
Slide 8: TD-1473: Phase 1b Study Progressing in Ulcerative Colitis Patients
Phase 1b designed to evaluate safety, tolerability, PK and PD of TD-1473 in moderately-to-severely active ulcerative colitis patients over 28 days Secondary/exploratory objectives to demonstrate biologic effect through biomarker analysis and clinical, endoscopic and histologic assessments TD-1473: P
Slide 9: Evidence of Localized Target Engagement and Minimal Systemic Exposure from Cohort 1
Evidence of Localized Target Engagement and Minimal Systemic Exposure from Cohort 1 of TD-1473 Phase 1b TD-1473 to advance into induction and maintenance study in 2018 Minimal Systemic Exposure; No Evidence of Systemic Immunosuppression Minimal levels of drug in plasma, consistent with SAD/MAD in he
Slide 10: TD-9855 NSRI for neurogenic orthostatic hypotension (nOH)
TD-9855 Dual norepinephrine and serotonin reuptake inhibitor (NSRI) for neurogenic orthostatic hypotension (nOH)
Slide 11: Neurogenic Orthostatic Hypotension (nOH) Represents a Significant Unmet Need
Neurogenic Orthostatic Hypotension (nOH) Represents a Significant Unmet Need nOH is characterized by a sustained drop in blood pressure that occurs upon standing up and is associated with the nervous system, specifically due to the body producing insufficient levels of norepinephrine Associated with
Slide 12: 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 13: 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 14: Velusetrag (TD-5108) for gastroparesis
Velusetrag (TD-5108) Highly selective 5-HT4 agonist for gastroparesis
Slide 15: Encouraging Development Progress for Velusetrag
Encouraging Development Progress for Velusetrag Highly selective 5-HT4 receptor agonist with high intrinsic activity Partnered ex-US with Alfasigma2 FDA Fast Track designation in gastroparesis Long term tox and carc studies complete Two studies complete in gastroparesis Symptom improvements at 5 mg
Slide 16: Phase 2b Results Provide POC in Symptom Effect
Phase 2b Results Provide POC in Symptom Effect First Clinical Evaluation of Effect of Velusetrag on Symptoms of Gastroparesis Scintigraphy Retention % after 28 Days Dosing LS Mean Change from Baseline GCSI Total Score Weeks Hours *Nominal p value for all doses < 0.001 versus placebo *Nominal p-value
Slide 17: Developing Proprietary PRO to Validate for Phase 3
Developing Propriety PRO to Validate for Phase 3 Gastroparesis Rating Scale (GRS) Designed in Alignment with FDA Guidance Week 4 GRS Subscale Score LS Mean Change from Baseline GRS Total Score Weeks *Nominal p-value < 0.05 on difference from placebo Treatment Period Follow-up GRS evaluates 7 symptom
Slide 18: Neprilysin Inhibitor (NEPi) Program
Neprilysin Inhibitor (NEPi) Program Potential Best-in-Class Therapeutic for Cardiovascular and Renal Disease
Slide 19: 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 20: 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 21: Acute Care Commercial Infrastructure Positioned to Support VIBATIV and Revefenacin
Acute Care Commercial Infrastructure Positioned to Support VIBATIV® and Revefenacin Label Expansion Strategy for VIBATIV Growth Complementary Products to Optimize the Acute Care Organization Potential for broadest set of indications of any branded anti-MRSA antibiotic Approval in cSSSI and HABP/VABP
Slide 22: Compelling Need for Once-Daily Nebulized LAMA
Compelling Need for Once-Daily Nebulized LAMA Enduring Patient Niche and Significant Market Opportunity Unmet Need for Nebulized LAMA Therapy Once-daily LAMAs are first-line therapy for moderate to severe COPD1 No nebulized LAMAs available today; only available in handheld devices Nebulized therapy
Slide 23: Revefenacin: Phase 3 Registrational Program Complete, NDA Filing Planned in Late 2017
* P < 0.0001 versus placebo ** P <0.001 versus placebo * ** * * * ** Revefenacin: Phase 3 Registrational Program Complete, with NDA Filing Planned in Late 2017 Primary endpoint achieved for both doses in both replicate efficacy studies Robust and sustained improvements in FEV1 Effective as monothera
Slide 24: Opportunities for Value Creation
Opportunities for Value Creation Economic Interests and Upcoming Milestones
Slide 25: 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 26: Upcoming Milestones
Upcoming Milestones Program Milestone Target TD-1439 (NEP inhibitor) Phase 1a SAD/MAD results in healthy volunteers Completed Revefenacin (TD-4208) Phase 3 long-term safety results in COPD patients Completed Velusetrag (TD-5108) Phase 2b results in Gastroparesis patients Completed TD-1473 (JAK inhib
Slide 27: 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 28: 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 29: VIBATIV (telavancin) Important Safety Information (US)
VIBATIV® (telavancin) Important Safety Information (US) Mortality Patents wih pre-existing moderatelsevere renal impairment (Cr sO mLini) who were weoed wih VIBATIV® fr hospts-acquired bactral peumonia/veniatr associated Dactrlal pneumenia had increased morally served versus vancomycin. Use of VIBAT
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