Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Q2 2019 Earnings Presentation
17 slides from Theravance Biopharma's earnings presentation, Jul 31, 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 TRELEGY ELLIPTA is FF/UMEC/VI or fluticasone furoate/umeclidinium/vilanterol; comprised of ICS, LAMA, and LABA, active components of Anoro (UMEC/VI). 1
Slide 3: TD-1473: Gut-selective oral JAK inhibitor
TD-1473: Gut-selective oral JAK inhibitor LATE STAGE STUDIES IN ULCERATIVE COLITIS AND CROHN’S DISEASE 1 Maintenance phase of the study will have induction responder subjects re-randomized to active doses compared to placebo at 44 weeks Crohn’s disease Ulcerative colitis Phase 2 (N=160) Dose-finding
Slide 4: TD-1473 Research Vision
5 TD-1473 Research Vision ORGAN-SELECTIVE APPROACH DESIGNED TO EXPAND THERAPEUTIC INDEX 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
Slide 5: Ampreloxetine: Phase 2 Study in nOH
Ampreloxetine: Phase 2 Study in nOH DESIGNED TO EVALUATE INITIAL AND DURABLE RESPONSE TO THERAPY 6 Purpose: To evaluate the effect of ampreloxetine in improving blood pressure and key nOH symptoms Part C: Responders in Part A eligible for open-label treatment for up to 5 months Designed to assess du
Slide 6: Ampreloxetine: Phase 2 Results in nOH
7 Ampreloxetine: Phase 2 Results in nOH Mean Change From Baseline in OHSA and OHDAS Composite Scores (Symptomatic Subjects1) 1Baseline OHSA #1 >4 points. Negative change indicates improvement. OHDAS, Orthostatic Hypotension Daily Activity Scale; OHSA, Orthostatic Hypotension Symptom Assessment. Effi
Slide 7: Ampreloxetine Clinical Program
Ampreloxetine Clinical Program PHASE 3 REGISTRATIONAL PROGRAM IN SYMPTOMATIC NOH 8 Phase 2 data supportive of ongoing Phase 3 program; Phase 3 4-week efficacy data expected 2H 2020 Study 0169: 4 weeks (N=188) Randomized, double-blind, placebo-controlled, parallel group Study 0170: 22 weeks (N=254) R
Slide 8: TD-8236: Lung-selective Inhaled pan-JAK Inhibitor
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-9 Mixed granulocytic Eosinophilic Neutrophilic Paucigranulocytic Patient heterogeneity in severe asthma Th2-low Th2-high Bold denotes biologics in development or approved Novel approved bi
Slide 9: YUPELRI®: Formal Commercial Launch Underway
YUPELRI®: Formal Commercial Launch Underway FDA-APPROVED FOR THE MAINTENANCE TREATMENT OF COPD 10 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 10: Compelling Need for Once-Daily Nebulized LAMA
Compelling Need for Once-Daily Nebulized LAMA ENDURING PATIENT NICHE AND SIGNIFICANT MARKET OPPORTUNITY 11 Enduring patient niche 9% of COPD patients currently use nebulizers for ongoing maintenance therapy 1 >100M patient treatment days in nebulized COPD segment 2 41% of COPD patients use nebulizer
Slide 11: Partnership with Mylan Brings Commercial Strength in Nebulized Opportunity
Partnership with Mylan Brings Commercial Strength in Nebulized Opportunity 12 HD = hospital discharge HCPs = health care providers Targeting HCPs at key intersections in the patient’s disease management process Hospital is an important site of care for patients with worsening of COPD symptoms Therav
Slide 12: YUPELRI® Launch Update
YUPELRI® Launch Update ENCOURAGING INITIAL MARKET RESPONSE 13 42 Wins (equates to 136 accounts) ~93 Reviews Scheduled (~405 potential accounts) 100% medical support requests fulfilled <30 days FORMULARY Field force productivity goals exceeded ~7,000 patients prescribed (thru 2Q19) PATIENT 100% Medic
Slide 13: Opportunity for YUPELRI® (revefenacin) in China
Opportunity for YUPELRI® (revefenacin) in China POTENTIAL TO ADDRESS LARGE AND UNDERSERVED COPD PATIENT POPULATION 14 Expansion of development and commercialization agreement Mylan granted exclusive development and commercialization rights to revefenacin in China and adjacent territories Theravance
Slide 14: Second Quarter 2019 Financial Highlights
1 Cash, cash equivalents, and marketable securities 2 Amounts include share-based compensation 15 Three Months Ended, June 30, ($, in thousands) 2019 2018 (Unaudited) Product sales - 5,361 Collaboration revenue 7,650 18,115 License revenue 18,500 - Profit sharing revenue - - Total revenue 26,150 23,
Slide 15: GSK’s TRELEGY ELLIPTA
GSK’s TRELEGY ELLIPTA FIRST AND ONLY ONCE-DAILY SINGLE INHALER TRIPLE THERAPY 16 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 36
Slide 16: Key programs drive near- and long-term value-creating events
Key programs drive near- and long-term value-creating events Focus on Strategic Priorities COMMITMENT TO CREATING TRANSFORMATIONAL MEDICINES 17 TRELEGY ELLIPTA is FF/UMEC/VI or fluticasone furoate/umeclidinium/vilanterol; comprised of ICS, LAMA, and LABA, active components of Anoro (UMEC/VI). 1 TBPH
Slide 17: Focus on Strategic Priorities
Focus on Strategic Priorities COMMITMENT TO CREATING TRANSFORMATIONAL MEDICINES Opportunities to Create Transformational Medicines Economic Interest