Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Q3 2019 Earnings Presentation
17 slides from Theravance Biopharma's earnings presentation, Nov 5, 2019
Slide 1: Third Quarter 2019 Financial Results & Business Update
Theravance Biopharma, Inc. (NASDAQ: TBPH) Third Quarter 2019 Financial Results & Business Update November 5, 2019 THERAVANCE ® , the Cross/Star logo, and MEDICINES THAT MAKE A DIFFERENCE ® are registered trademarks of the Theravance Biopharma group of companies. All third party trademarks used herei
Slide 2: 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 t
Slide 3: Focus on Strategic Priorities
Focus on Strategic Priorities KEY PROGRAMS DRIVE NEAR AND LONG - TERM VALUE - CREATING EVENTS TRELEGY ELLIPTA is FF/UMEC/VI or fluticasone furoate/umeclidinium/vilanterol; comprised of ICS, LAMA, and LABA, active compon ent s of ANORO (UMEC/VI). 1 TBPH holds 85% economic interest in upward - tiering
Slide 4: TD-1473: Gut-selective Oral Pan-JAK Inhibitor
TD - 1473: Gut - selective Oral Pan - 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 w eeks Crohn’s disease Ulcerative colitis Phase 2 (N=160)
Slide 5: TD-1473 Research Vision
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 fu
Slide 6: Ampreloxetine: Supplemental Phase Data in nOH
Ampreloxetine: Supplemental Phase 2 Data in nOH NOREPINEPHRINE PLASMA LEVELS & OHSA #1 IN SYMPTOMATIC PATIENTS Study Visit N=13 N=13 Day -1 (Pre-dose) Ampreloxetine Week 4 Open-label 0 1 2 3 4 5 6 7 8 9 10 O H S A # 1 S c o r e N=12 N=11 Day 1 Pre-dose Ampreloxetine Week 4 Open-label 0 1000 2000 300
Slide 7: Ampreloxetine: Norepinephrine Reuptake Inhibitor (NRI)
Ampreloxetine: Norepinephrine Reuptake Inhibitor (NRI) PHASE 3 REGISTRATIONAL PROGRAM IN SYMPTOMATIC NOH 7 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
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 - γ 8 38 19 29 7 Mixed granulocytic Eosinophilic Neutrophilic Paucigranulocytic Patient heterogeneity in severe asthma Th2 - low Th2 - high Bold denotes biologics in dev
Slide 9: TD-8236: Positive Phase 1 Trial in Healthy Subjects and Mild Asthmatics
TD - 8236: Positive Phase 1 Clinical Trial in Healthy Subjects and Mild Asthmatics 9 Data demonstrated evidence of biological activity in the lung with minimal systemic exposure FeNO , fractional exhaled nitric oxide. Key Findings Favorable overall safety and tolerability No evidence of local irrita
Slide 10: TD-8236: Preliminary Positive FeNO Data in Mild Asthma
TD - 8236: Preliminary Positive FeNO Data in Patients with Mild Asthma & Elevated FeNO Levels at Baseline FeNO , fractional exhaled nitric oxide. 10 6 - Hour Post - Dose FeNO Day -16 -14 -12 -10 -8 -6 -4 -2 0 2 1 2 3 4 5 6 7 BL 4000µg 500µg 1500µg 150µg ‣ FeNO is an established disease activity biom
Slide 11: TD-5202: Gut-selective Irreversible JAK3 Inhibitor
‣ Proof - of - relevance for T - cell mediated disease from positive Phase 2 data with systemic JAK3 inhibitor in alopecia areata 1 ‣ Localized JAK3 inhibition important to avoid systemic immunosuppression (genetic JAK3 deficiency leads to severe immunodefici enc y) ‣ Phase 1 study of TD - 5202 in h
Slide 12: YUPELRI: Commercial Launch Underway
YUPELRI ® : Commercial Launch Underway FDA - APPROVED FOR THE MAINTENANCE TREATMENT OF COPD 12 YUPELRI ® (revefenacin) inhalation solution. Approved for the maintenance treatment of patients with COPD. COPD = Chronic Obstructive P ulm onary Disease. 1 Global Strategy for Diagnosis, Management, and P
Slide 13: Partnership with Mylan Brings Commercial Strength in Nebulized Opportunity
Partnership with Mylan Brings Commercial Strength in Nebulized Opportunity 13 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 ‣ Th
Slide 14: YUPELRI Launch Update
YUPELRI ® Launch Update ENCOURAGING INITIAL MARKET RESPONSE 1 70 Wins (equates to 196 accounts) ~60 Reviews Scheduled (>300 potential accounts) 100% medical support requests fulfilled <30 days FORMULARY Field force productivity goals exceeded ~21,000 patients prescribed (thru Q3 2019) PATIENT 100% M
Slide 15: Third Quarter 2019 Financial Results
1 Cash, cash equivalents, marketable securities, and restricted cash. 2 Amounts include share - based compensation. 3 Operating loss excluding share - based compensation. Operating loss guidance does not include royalty income for TRELEGY ELLIPTA which the Company recognizes as non - operating incom
Slide 16: GSK's TRELEGY ELLIPTA
GSK’s TRELEGY ELLIPTA FIRST AND ONLY ONCE - DAILY SINGLE INHALER TRIPLE THERAPY 1 6 Economic interest in TRELEGY ELLIPTA ‣ Upward - tiering royalty of ~5.5% - 8.5% of worldwide net sales 1 ‣ Passive economic interest; no product cost obligations Growth continues after first full year on market Presc
Slide 17: Focus on Strategic Priorities
Focus on Strategic Priorities KEY PROGRAMS DRIVE NEAR AND LONG - TERM VALUE - CREATING EVENTS 17 TRELEGY ELLIPTA is FF/UMEC/VI or fluticasone furoate/umeclidinium/vilanterol; comprised of ICS, LAMA, and LABA, active compon ent s of ANORO (UMEC/VI). 1 TBPH holds 85% economic interest in upward - tier