Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Q1 2019 Earnings Presentation
17 slides from Theravance Biopharma's earnings presentation, May 7, 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: Focus on Strategic Priorities
Significant existing cash resources to fund strategic priorities2 Focus on Strategic Priorities COMMITMENT TO CREATING TRANSFORMATIONAL MEDICINES 3 1 TBPH holds 85% economic interest in upward-tiering royalty stream of 6.5% – 10% payable by GSK (net of TRC LLC expenses paid and the amount of cash, i
Slide 3: GSK's TRELEGY ELLIPTA: First and Only Once-Daily Single Inhaler Triple Therapy
GSK’s TRELEGY ELLIPTA FIRST AND ONLY ONCE-DAILY SINGLE INHALER TRIPLE THERAPY 4 Economic interest in TRELEGY ELLIPTA Upward-tiering royalty of ~5.5% - 8.5% of worldwide net sales1 Passive economic interest; no product cost obligations Growth continues after first full year on market Available in 30
Slide 4: TD-1473 Research Vision: Oral Gut-Selective Pan-JAK Inhibitor
5 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 5: TD-1473 Clinical Program
Phase 3 induction, 2 arms (N=640) Dose-confirming induction, 8 weeks Phase 2b induction, 4 arms (N=240) Dose-finding induction, 8 weeks 6 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 week
Slide 6: Organ-selective Approach
7 Conventional Systemic Compound EFFECTIVE NON-EFFECTIVE DOSE-LIMITING SAFETY NON-EFFECTIVE DOSE-LIMITING SAFETY EFFECTIVE Theravance Biopharma Organ-selective Compound Illustrated example: lung selectivity Opportunity to increase dose for improved efficacy, without cost of systemic safety risk Expa
Slide 7: Gut-selective Design
Gut-selective Design INFLAMMATION TREATED AT THE TISSUE OF INTEREST 8 Metabolism Gut-selective JAK inhibitor Absorption Metabolism Absorption Systemic JAK inhibitor To feces Gut wall & mucosa Liver Portal vein Intestine To feces Gut wall & mucosa Liver Portal vein Intestine Systemic Circulation Syst
Slide 8: TD-1473: Innovative Approach in Treating IBD
TD-1473: Innovative Approach in Treating IBD compelling Preclinical PACKAGE AND ENCOURAGING Phase 1b DATA 9 Gut selectivity Potent inhibition of Tyk2 Anti-inflammatory activity in disease model Lumen Vehicle treated control TD-1473 treatment Inhibitory potency (pKi) Tyk2 7.5 8 8.5 9 9.5 10 Tofacitin
Slide 9: Ampreloxetine: Top-line Phase 2 Results in nOH
10 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 10: Ampreloxetine Clinical Program
Ampreloxetine Clinical Program PHASE 3 REGISTRATIONAL PROGRAM IN SYMPTOMATIC NOH 11 De Novo Study 0169 4 weeks (N=188) Randomized, double blind, placebo-controlled, parallel group study Study 0170 22 weeks (N=258) Randomized 6-week withdrawal phase (preceded by 4-month open label) Supportive 5-month
Slide 11: TD-8236: Lung-selective Pan-JAK Inhibitor
TD-8236: Lung-selective pan-JAK Inhibitor POTENTIAL TO ADDRESS PATIENTS NEEDS REGARDLESS OF TH2 PHENOTYPE JAK/STAT cytokines implicated in severe asthma Patient heterogeneity in severe asthma 19 Neutrophilic 38 Th2-low 29 Eosinophilic Paucigranulocytic Bold denotes biologics in development or approv
Slide 12: YUPELRI: Formal Commercial Launch Underway
YUPELRI®: Formal Commercial Launch Underway FDA-APPROVED FOR THE MAINTENANCE TREATMENT OF COPD 13 YUPELRI® (revefenacin) inhalation solution. Approved for the maintenance treatment of patients with COPD. COPD = Chronic Obstructive Pulmonary Disease. 1 Global Strategy for Diagnosis, Management, and P
Slide 13: Partnership with Mylan Provides Commercial Strength in Nebulized Opportunity
Partnership with Mylan Provides Commercial Strength in Nebulized Opportunity 14 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 ma
Slide 14: YUPELRI Launch Update
YUPELRI® Launch Update ENCOURAGING INITIAL MARKET RESPONSE ACCESS FORMULARY PATIENT 17 Wins (equates to 63 accounts) Field force productivity goals exceeded ~50% Commercial 72 Reviews Scheduled (~280 potential accounts) 100% Medicare Part B (for patients with supplemental insurance) ~4,500 patients
Slide 15: First Quarter 2019 Financial Highlights
First Quarter 2019 Financial Highlights Three Months Ended, March 31, ($, in thousands) 2019 2018 (Unaudited) - 5,338 Product sales Collaboration revenue Total revenue Cost of good sold Research and development1 Selling, general and administrative1 Total costs and expenses Loss from operations 3,679
Slide 16: Strategic Focus with Inflection Points Near- and Long-term
Strategic Focus with Inflection Points Near-and Long-term Differentiated organ-selective projects advancing to clinical development Economic interest in TRELEGY ELLIPTA serves as an important strategic asset1 – Strong launch following approvals in US and EU in late 2017 1 TBPH holds 85% economic int
Slide 17: Strategic Focus with Inflection Points Near- and Long-term
Strategic Focus with Inflection Points Near- and Long-term Formal Launch Underway Pivotal Phase 3 program in Phase 2 DIONE study in Crohn’s symptomatic nOH progressing _—_disease and Phase 2b/3 RHEA First and only once-daily nebullzed study in ulcerative colitis ongoing LAMA for treatment of COPD Du