Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — FY2018 Earnings Presentation
16 slides from Theravance Biopharma's earnings presentation, Feb 26, 2019
Slide 1: Forward Looking Statements
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 may cause actual results to diff
Slide 2: 2018 Key Milestones
3 First patient dosed in Phase 2 study in Crohn’s TD-1473 Patient screening in Phase 2b/3 study in UC TD-1473 4-week results of Phase 2 study in nOH Ampreloxetine Sites initiated for Phase 3 program enrollment Ampreloxetine Global collaboration agreement with Janssen TD-1473 Completion of Phase 1b s
Slide 3: Maximize Efficacy and Minimize Adverse Events
4 Maximize Efficacy and Minimize Adverse Events SYSTEMIC THERAPIES OFTEN FAIL TO ACHIEVE MAXIMAL EFFICACY DUE TO DOSE LIMITING SAFETY Conventional Systemic Drugs Organ-selective Drugs EFFECTIVE NON-EFFECTIVE DOSE-LIMITING SAFETY NON-EFFECTIVE DOSE-LIMITING SAFETY EFFECTIVE Illustrated example: lung
Slide 4: JAK-STAT Pathway
5 Clark JD, et al. J Med Chem 2014; 57:5023-5038. JAK-STAT Pathway ORCHESTRATING SIGNALING OF MULTIPLE PRO-INFLAMMATORY CYTOKINES STAT-induced Inflammation Nucleus STAT P STAT P STAT P STAT P STAT JAK JAK JAK inhibitor c cytokines (IL-2, IL-4, IL-7, IL-9, IL-15, IL-21) Type 1 IFNs, IL-10 family IL-6
Slide 5: TD-1473 Research Vision: Oral Gut-Selective Pan-JAK Inhibitor
6 TD-1473 Research Vision: ORAL GUT-SELECTIVE PAN-JAK INHIBITOR Treat disease at site to maximize efficacy Optimize pharmacology to include potent inhibition of Tyk2 Improve upon the efficacy of a clinically validated target WARNING: SERIOUS INFECTIONS AND MALIGNANCY See full prescribing information
Slide 6: Differentiated organ-selective projects advancing to clinical development
7 Differentiated organ-selective projects advancing to clinical development, featured at December 2018 R&D Day Economic interest in TRELEGY ELLIPTA serves as an important strategic asset1 Strong launch following approvals in US and EU in late 2017 Pivotal Phase 3 program in symptomatic nOH progressi
Slide 7: YUPELRI: Formal Commercial Launch Underway
YUPELRITM: Formal Commercial Launch Underway FDA-APPROVED FOR THE MAINTENANCE TREATMENT OF COPD 8 YUPELRITM (revefenacin) inhalation solution. Approved for the maintenance treatment of patients with COPD. COPD = Chronic Obstructive Pulmonary Disease. 1 Global Strategy for Diagnosis, Management, and
Slide 8: Partnership with Mylan Provides Commercial Strength in Nebulized Opportunity
Partnership with Mylan Provides Commercial Strength in Nebulized Opportunity 9 HD = hospital discharge. 1 IMS Health information service: NSP for period MAT May, 2015. Excludes nebulized SABAs. IMS expressly reserves all rights, including rights of copying, distribution and republication. 2 TBPH mar
Slide 9: TD-1473: Late-stage Studies in UC and Crohn's Disease
Phase 3 induction, 2 arms (N=640) Dose-confirming induction, 8 weeks Phase 2b induction, 4 arms (N=240) Dose-finding induction, 8 weeks 10 Phase 3 maintenance 44 weeks Phase 2b/3 study in ulcerative colitis Phase 2 study in Crohn’s disease Phase 2 study, 3 arms (N=160) Dose-finding induction, 12 wee
Slide 10: Ampreloxetine: Top-line Phase 2 Results in nOH
11 Ampreloxetine: Top-line Phase 2 Results in nOH PART B and C: VERSUS PLACEBO and REPEAT DOSE EXTENSION PHASE Positive results including durability of effect provide basis for registrational Phase 3 program in symptomatic nOH SBP = systolic blood pressure. OHSA = orthostatic hypotension symptom ass
Slide 11: TD-8236: Potential for Inhaled Pan-JAKi to Address Needs of Patients
JAK/STAT cytokines implicated in severe asthma Th2 High Th2 Low IL-4 IL-23/IL-12 IL-13 IL-6 IL-5 IL-27 TSLP IFN- 12 Mixed granulocytic Eosinophilic Neutrophilic Paucigranulocytic Patient heterogeneity in severe asthma Th2 Low Th2 High Bold denotes biologics in development or approved Novel approved
Slide 12: 4Q and Full Year 2018 Financial Highlights
13 4Q and Full Year 2018 Financial Highlights Three Months Ended, December 31, Year Ended December 31, ($, in thousands) 2018 2017 2018 2017 Unaudited Unaudited (1) Product sales 2,415 4,124 15,304 14,788 Collaboration revenue 10,047 391 41,791 598 Profit sharing revenue 3,275 - 3,275 - Total Revenu
Slide 13: GSK's TRELEGY ELLIPTA: Strong Early Trajectory
GSK’s TRELEGY ELLIPTA: Strong Early Trajectory FIRST AND ONLY ONCE-DAILY SINGLE INHALER TRIPLE THERAPY 14 Economic interest in TRELEGY ELLIPTA Upward-tiering royalty of approximately 5.5% - 8.5% of worldwide net sales1 Passive economic interest; no product cost obligations Impressive progress follow
Slide 14: Focus on Strategic Priorities
Significant existing cash resources to fund strategic priorities2 Focus on Strategic Priorities COMMITMENT TO CREATING TRANSFORMATIONAL MEDICINES 15 1 Economic interest managed by GSK and Innoviva. Innoviva formerly Theravance, Inc. TBPH holds 85% economic interest in upward-tiering royalty stream o
Slide 15: Building Near- and Long-term Value
16 YUPELRITM (revefenacin) inhalation solution TRELEGY ELLIPTA YUPELRITM Ampreloxetine TD-1473 TD-8236 Emerging organ-selective programs Building Near- and Long-term Value
Slide 16: Building Near- and Long-term Value
Building Near- and Long-term Value Emerging organ-selective programs TD-1473 Ampreloxetine YUPELRI™ TRELEGY ELLIPTA vanes