Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — FY2020 Earnings Presentation
23 slides from Theravance Biopharma's earnings presentation, Feb 23, 2021
Slide 1: Fourth Quarter and Full Year 2020 Financial Results and Business Update
Fourth Quarter and Full Year 2020 Financial Results and Business Update February 23, 2021 THERAVANCE BIOPHARMA ® , THERAVANCE ® , the Cross/Star logo and MEDICINES THAT MAKE A DIFFERENCE ® are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countri
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: Agenda
Agenda 3 Introduction Gail B Cohen Vice President, Corporate Communications Overview Rick E Winningham Chief Executive Officer Commercial and Development Update Frank Pasqualone Senior Vice President, Chief Business Officer Brett Haumann, M.D. Senior Vice President, Chief Medical Officer Financial U
Slide 4: 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 Izencitinib (TD - 1473) GI JAKi UC CD Janssen Biotech, Inc . TD - 5202 Irreversible JAK3i Inflammatory intestinal diseases YUPELRI ® (revefe
Slide 5: YUPELRI (revefenacin) inhalation solution
YUPELRI ® (revefenacin) inhalation solution 1. Global Strategy for Diagnosis, Management, and Prevention of COPD, 2018. 2. TBPH market research (N = 160 physicians); refers to US COPD patients. COPD, chronic obstructive pulmonary disease; LAMA, long - acting muscarinic receptor antagonist. 5 Once -
Slide 6: YUPELRI hospital sales and community TRx trends
YUPELRI ® hospital sales and community TRx trends Continued growth through Q4’20 across both the hospital and retail channels 0.3% 1.1% 2.2% 3.4% 5.4% 6.5% 6.3% 7.5% 0% 2% 4% 6% 8% 10% 12% 14% 16% 18% 20% Q1'19 Q2'19 Q3'19 Q4'19 Q1'20 Q2'20 Q3'20 Q4'20 Hospital LA - NEB Market Share* Hospital Market
Slide 7: TBPH implied 35% of YUPELRI US net sales by quarter
TBPH implied 35% of YUPELRI ® US net sales by quarter See TBPH 10Q filed Nov 9, 2020 for greater detail re TBPH implied 35%. 7 TBPH implied 35% of YUPELRI US net sales represents TBPH’s split of the combined TBPH and VIATRIS net revenue Growth in net sales through Q1’20 and recovery in Q3’20 driven
Slide 8: Nebulized lung-selective pan-JAK inhibitor program
TD - 0903 Program Nebulized lung - selective pan - JAK inhibitor to treat: ► Acute hyperinflammation of the lung in COVID - 19 ► Chronic inflammation for the treatment and prevention of lung transplant rejection
Slide 9: Phase 2 study in hospitalized COVID-19 patients
TD - 0903: a two - part placebo - controlled Phase 2 study in hospitalized patients with COVID - 19 requiring oxygen support PK, pharmacokinetics; SOC, standard of care. *Loading dose (double the standard dose) administered on Day 1. NCT04402866 . 9 Dose 3 mg* + SOC Placebo + SOC 1 mg* 3 mg* 10 mg D
Slide 10: Executive Summary
Executive Summary CRP, C - reactive protein; IL, interleukin; PK, pharmacokinetics; RAGE, receptor for advanced glycation end - products; S/F ratio, r atio of oxygen saturation in the blood vs the flow of oxygen administered to the patient. 10 Safety & Tolerability Findings ‣ TD - 0903 was generally
Slide 11: Clinical status through Day 7 versus placebo
TD - 0903 appears to stabilize clinical status within 7 days, compared to placebo ‣ TD - 0903 showed a positive trend toward more clinical improvement ‣ 50% of placebo patients required mechanical ventilation by Day 6 Placebo pooled from Cohorts 1 – 3; ECMO, extracorporeal membrane oxygenation. Hosp
Slide 12: Clinical status through 28 days versus placebo
TD - 0903 shows numerical improvement in clinical status compared to placebo through 28 days ‣ 2 deaths on placebo and 1 death on 1mg, but none on 3 and 10mg groups ‣ More patients out of hospital and with no limitations by Day 28 with TD - 0903 than placebo Placebo pooled from Cohorts 1 – 3; ECMO,
Slide 13: Lung-selective profile demonstrates low plasma exposure
TD - 0903 lung - selective profile demonstrates low plasma exposure ‣ Day 7 steady - state exposures of TD - 0903 approximately dose proportional ‣ Initial loading dose on Day 1 for 1 mg and 3 mg doses in order to achieve near - steady - state exposures as quickly as possible ‣ Plasma exposures were
Slide 14: Positive trend in blood oxygenation (S/F ratio)
2 3 4 5 6 7 -100 -50 0 50 100 150 Day M e a n S a O 2 / F i O 2 R a t i o C h a n g e F r o m B a s e l i n e ( S E M ) TD - 0903 3 mg showed positive trend in improving blood oxygenation versus placebo as measured by S/F Ratio SEM, standard error of mean; S/F ratio, ratio of oxygen saturation in th
Slide 15: Economic interest in GSK's TRELEGY ELLIPTA
Economic interest GSK’s TRELEGY ELLIPTA (FF/UMEC/VI): First and only once - daily single inhaler triple therapy
Slide 16: Economic interest in GSK's TRELEGY
Economic interest in GSK’s TRELEGY Q4 net sales of £238MM (or $315MM) Full year - over - year sales growth of 60% US asthma indication approved September 9, 2020, and launched Q3 ‣ Results from the CAPTAIN study published in The Lancet Respiratory Medicine 1. TBPH holds 85% economic interest in upwa
Slide 17: 2021 Financial Guidance
2021 Financial Guidance 17 2020 Actuals GAAP (Including share - based comp) Non - GAAP (Excluding share - based comp) R&D Expense $261M $230M SG&A Expense $109M $77M Total Operating Loss $298M $235M (used for 2020 guidance) 2021 Guidance Non - GAAP (Excluding share - based comp) $195M - $225M $80M -
Slide 18: Multiple potential milestones and value-driving catalysts
Q4 Q2 Q3 Q1 2021 Multiple potential milestones & value - driving catalysts TBPH holds 85% economic interest in upward - tiering royalty stream of 6.5% – 10% payable by GSK (net of TRC expenses paid and the amount of cash, if any, expected to be used by TRC pursuant to the TRC Agreement over the next
Slide 19: 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 20: 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 co
Slide 21: Appendix
Appendix THERAVANCE BIOPHARMA ® , THERAVANCE ® , the Cross/Star logo and MEDICINES THAT MAKE A DIFFERENCE ® are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries). All third party trademarks used herein are the property of their respective
Slide 22: Nebulized lung-selective pan-JAK inhibitor program
TD - 0903 Program Nebulized lung - selective pan - JAK inhibitor to treat: ► Acute hyperinflammation of the lung in COVID - 19 ► Chronic inflammation for the treatment and prevention of lung transplant rejection
Slide 23: Reduces relevant systemic biomarkers
% Difference in GM From BL (95% CI) TD - 0903 3 mg reduces relevant systemic biomarkers BL, baseline; CI, confidence interval; CRP, C - reactive protein; GM, geometric mean; IL, interleukin; RAGE, receptor for advanced glycation end - products. 23 -200 -100 0 100 200 300 400 -200 -100 0 100 200 300