Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Q1 2020 Earnings Presentation
30 slides from Theravance Biopharma's earnings presentation, May 6, 2020
Slide 1: First Quarter 2020 Financial Highlights and Business Update
First Quarter 2020 Financial Highlights and Business Update May 6, 2020 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 herein are the property of their respective owner
Slide 2: Forward-looking statements
Forward - looking statements 2 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 resul
Slide 3: Q1 Financial highlights and business update agenda
Q1 Financial highlights and business update agenda 3 Introduction Gail B. Cohen Vice President, Corporate Communications & Investor Relations Overview Rick E Winningham Chief Executive Officer Commercial and Development Update Brett Haumann, M.D. Senior Vice President, Chief Medical Officer Frank Pa
Slide 4: Theravance Biopharma response to COVID-19
Theravance Biopharma response to COVID - 19 4 ‣ Travel restrictions and remote work since early March ‣ Lab - based employees, with appropriate safety precautions, contributing in the labs ‣ Suspended in - person customer visits ‣ COVID - 19 Task Force established SAFEGUARD EMPLOYEES/ COMMUNITIES ‣
Slide 5: Respiratory experience
Respiratory experience ‣ Historical involvement in development of beta - agonists in collaboration with GSK to support combination therapies (ANORO ELLIPTA, BREO ELLIPTA, TRELEGY ELLIPTA)* ‣ Discovered and developed YUPELRI ® (revefenacin) inhalation solution, the first and only once - daily, nebuli
Slide 6: TD-0903 Nebulized lung-selective pan-JAK inhibitor
TD - 0903 Nebulized lung - selective pan - JAK inhibitor Goal: Inhibit the cytokine storm associated with Acute Lung Injury (ALI) and prevent progression to Acute Respiratory Distress Syndrome (ARDS)
Slide 7: Potential for TD-0903 effect
Potential for TD - 0903 effect Host inflammatory response to COVID - 19 drives ALI and ARDS Adapted from Siddiqi HK, et al. J Heart Lung Transplant 2020 Mar 20. 7 7 Clinical symptoms Clinical signs Potential therapies Mild constitutional symptoms Fever >99.6 ° F Dry cough, diarrhea, headache Shortne
Slide 8: Multiple pathogenic processes contribute to alveolar injury during ALI and ARDS
Multiple pathogenic processes contribute to alveolar injury during ALI and ARDS 1 ‣ Host factors driving the initiation and progression of exuberant inflammatory response 2 – Rapid viral replication – Infection of alveolar epithelial cells – Delayed IFN response – Macrophage and neutrophil accumulat
Slide 9: TD-0903: Potent, lung-selective pan-JAK inhibitor
Bronchoalveolar lavage fluid lymphocytes and relevant mediators inhibited by OA tool JAK inhibitor TR065925. Based on internal data on file. Tyk, Tyrosine kinase. ‣ High affinity for JAK1, JAK2, JAK3, and Tyk2 kinase domains ‣ High potency for inhibition of cytokine - induced activation of JAK - STA
Slide 10: TD-0903: Development plan designed to progress rapidly
TD - 0903: Development plan designed to progress rapidly Program is subject to ongoing regulatory and IRB review and approval SOC, standard of care. 10 Phase 1: Healthy volunteers Dose 1 Dose 2 Dose 3 Dose 1 x 7 days Dose 2 x 7 days Dose 3 x 7 days Dose A + SOC x 7 days Dose B + SOC x 7 days Placebo
Slide 11: TD-8236 Inhaled lung-selective pan-JAK inhibitor
TD - 8236 Inhaled lung - selective pan - JAK inhibitor Goal: Treat moderate - to - severe asthma regardless of T2 phenotype
Slide 12: TD-8236: Preliminary positive FeNO data in mild asthmatics
-16 -14 -12 -10 -8 -6 -4 -2 0 2 BL 1 2 3 4 5 6 7 TD - 8236: Lung - selective pan - JAK inhibitor Preliminary positive FeNO data in mild asthmatics Phase 1 biomarker study in moderate - to - severe asthmatics ongoing; data expected 2H 2020 FeNO, fractional exhaled nitric oxide. 12 Phase 1 data; mild
Slide 13: TD-8236: Phase 2 allergen challenge study
TD - 8236: Lung - selective pan - JAK inhibitor Phase 2 allergen challenge study 13 Phase 2 allergen challenge study underway Data expected 2H 2020 TD - 8236 Phase 2 Lung Allergen Challenge 12 weeks (N=21) Dose characterization Randomized, double - blind, placebo - controlled, crossover study
Slide 14: YUPELRI (revefenacin) inhalation solution
YUPELRI ® (revefenacin) inhalation solution First and only once - daily, nebulized maintenance medicine for COPD
Slide 15: First and only once-daily, nebulized maintenance medicine for COPD
First and only once - daily, nebulized maintenance medicine for COPD YUPELRI ® (revefenacin) inhalation solution FDA - approved for the maintenance treatment of COPD 1. Global Strategy for Diagnosis, Management, and Prevention of COPD, 2018; 2. TBPH market research (N = 160 physicians); ref ers to U
Slide 16: YUPELRI launch metrics
Majority of YUPELRI ® volume flows through durable medical equipment channel (approximately 3 - month lag in data capture); remaining volume flows thro ugh hospitals, retail and long - term care pharmacies. Wholesale acquisition cost (WAC): $1,066 per month (or ~$35 per day). 1. As of April 30, 2020
Slide 17: TD-1473 (JNJ-8398) Oral gut-selective pan-JAK inhibitor
TD - 1473 (JNJ - 8398) Oral gut - selective pan - JAK inhibitor Goal: Treat inflammatory intestinal diseases
Slide 18: Development of Gut-Selective Pan-Janus Kinase Inhibitor TD-1473
Journal of Crohn's and Colts, 2020, 1-12 oto. 108a/ecco-jcfiaao19 ‘Advance Access publication March 11,2020 Original Article Original Article Development of Gut-Selective Pan-Janus Kinase Inhibitor TD-1473 for Ulcerative Coli A Translational Me e Programme William J. Sandborn,** Deanna D. Nguyen,”*
Slide 19: TD-1473: Late-stage studies in Crohn's disease and ulcerative colitis
TD - 1473: Gut - selective pan - JAK inhibitor Late - stage studies in Crohn’s disease and ulcerative colitis Phase 2 Crohn’s and Phase 2b/3 ulcerative colitis studies ongoing Phase 2 Crohn’s and Phase 2b ulcerative colitis data expected 2021 Global collaboration with Janssen leverages joint develop
Slide 20: Ampreloxetine (TD-9855)
Ampreloxetine (TD - 9855) Once - daily norepinephrine reuptake inhibitor in development for symptomatic neurogenic orthostatic hypotension
Slide 21: Ampreloxetine: Potential to provide meaningful and durable symptom improvement
Ampreloxetine: Potential to provide meaningful and durable symptom improvement to underserved patients Baseline OHSA #1 (Orthostatic Hypotension Symptom Assessment Question 1) >4 points. Negative change indicates improvement in symptoms; improvement of 1 point is defined as the MCID (minimal clinica
Slide 22: Key programs supported by proven development and commercial expertise
Program Indication Research Phase 1 Phase 2 Phase 3 Filed Marketed Collaborator Ampreloxetine (TD - 9855) NRI S ymptomatic nOH Wholly - owned Organ - selective TD - 1473 GI JAKi UC CD TD - 5202 Irreversible JAK3i Inflammatory intestinal diseases YUPELRI ® (revefenacin) LAMA COPD TD - 8236 Inhaled JA
Slide 23: Economic interest: GSK's TRELEGY ELLIPTA
Economic interest GSK’s TRELEGY ELLIPTA (FF/UMEC/VI): First and only once - daily single inhaler triple therapy
Slide 24: Economic interest in GSK's TRELEGY ELLIPTA
50 100 150 200 250 300 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 TRx Volume (Thousands) Month Post Launch Strongest US ELLIPTA launch to date ANORO ARNUITY BREO INCRUSE Economic interest in GSK’s TRELEGY ELLIPTA Upward - tiering royalties of ~5.5 – 8.5% of worl
Slide 25: First quarter 2020 financial highlights
1 Cash, cash equivalents and marketable securities. 2 Amounts include share - based compensation. 25 First quarter 2020 financial highlights Well capitalized with $492.1M 1 as of March 31, 2020 $, in thousands Three Months Ended March 31 2020 2019 (Unaudited) Collaboration revenue 6,632 5,338 Licens
Slide 26: The Theravance Biopharma Difference
The Theravance Biopharma Difference
Slide 27: Multiple potential milestones and value-driving catalysts
GSK’s TRELEGY ELLIPTA 1 ‣ FDA decision for asthma and separately for mortality benefit vs. ANORO in COPD TD - 8236 ‣ Phase 1 Part C data in severe asthmatics ‣ Phase 2 allergen challenge data Ampreloxetine ‣ Phase 3 4 - week efficacy data TD - 1473 ‣ Phase 2b/3 ulcerative colitis topline data ‣ Phas
Slide 28: In conclusion
In conclusion ‣ Continuing our strong collaboration with Janssen on our gut - selective compounds TD - 1473 and TD - 5202 28 ‣ Staying focused in respiratory and advancing our innovative lung - selective pipeline with TD - 0903 and TD - 8236 ‣ Continuing to drive YUPELRI ® sales growth ‣ Committed t
Slide 29: About YUPELRI (revefenacin) inhalation solution
About YUPELRI ® (revefenacin) inhalation solution YUPELRI ® (revefenacin) inhalation solution is a once - daily nebulized LAMA approved for the maintenance treatment of COPD in the US . Market research by Theravance Biopharma indicates approximately 9 % of the treated COPD patients in the US use neb
Slide 30: YUPELRI indication and Important Safety Information
YUPELRI ® (revefenacin) inhalation solution YUPELRI® inhalation solution is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) . Important Safety Information (US) YUPELRI is contraindicated in patients with hypersensitivity to revefenacin or any com