Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Q2 2017 Earnings Presentation
13 slides from Theravance Biopharma's earnings presentation, Aug 8, 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: 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 3: JAK Inhibitor Program
JAK Inhibitor Program Oral intestinally-restricted pan-Janus kinase (JAK) inhibitors for ulcerative colitis and other inflammatory intestinal diseases
Slide 4: 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 5: Evidence of Localized Target Engagement and Minimal Systemic Exposure from Cohort 1 of TD-1473
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 6: Velusetrag (TD-5108)
Velusetrag (TD-5108) Highly selective 5-HT4 agonist for gastroparesis
Slide 7: 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 8: 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 9: Revefenacin (TD-4208)
Revefenacin (TD-4208) Nebulized Long-Acting Muscarinic Antagonist (LAMA) for COPD
Slide 10: Revefenacin: Phase 3 Registrational Program Complete, with 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 11: 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 12: Upcoming Milestones
Upcoming Milestones Multiple Opportunities for Value Creation in Near-term ‘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 patien
Slide 13: Theravance Biopharma Q&A
Theravance ik’ Biopharma A. Medicines That Make a Difference” Q&A Theravance uv Biopharma 7”.