Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Q1 2022 Earnings Presentation
24 slides from Theravance Biopharma's earnings presentation, May 5, 2022
Slide 1: First Quarter 2022 Financial Results and Business Update
First Quarter 2022 Financial Results and Business Update May 5, 2022 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
Slide 2: Forward-looking statements safe harbor
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 differ materially from th
Slide 3: Agenda
Agenda 3 Introduction Gail B. Cohen Corporate Communications Overview Rick E Winningham Chief Executive Officer Commercial and Development Update Rhonda F. Farnum Senior Vice President, Chief Business Officer Richard A. Graham Senior Vice President, Research and Development Financial Update Andrew A
Slide 4: Rapid transition to a focused and streamlined Theravance Biopharma
Rapid transition to a focused and streamlined Theravance Biopharma 4 Significant cost reduction program reduces Company size to become sustainably cash - flow positive beginning 2H 2022 Focus on leveraging expertise in developing and commercializing respiratory therapeutics Streamlined R&D investmen
Slide 5: Key pillars of focused value creation plan
Key pillars of focused value creation plan 1. 1. Source: TBPH Analysts Consensus [8] December 9, 2021. 2. Source: Bloomberg GSK Analyst Consensus April 27, 2022. 3. TBPH h old s 85% economic interest in upward - tiering royalty stream of 6.5% – 10% payable by GSK (net of TRC expenses paid and the am
Slide 6: YUPELRI: FDA-approved for maintenance treatment of COPD
FDA - approved for maintenance treatment of COPD First and only once - daily, LAMA (long - acting muscarinic agent) nebulized maintenance medicine for COPD
Slide 7: YUPELRI (revefenacin) inhalation solution
‣ Once - daily LAMAs are first - line therapy for moderate - to - very severe COPD 1 ‣ 9% of COPD patients (~800,000) use nebulizers for ongoing maintenance therapy; 41% use nebulizers at least occasionally for bronchodilator therapy 2 YUPELRI ® ( revefenacin ) inhalation solution 1. Global Initiati
Slide 8: YUPELRI hospital performance accelerating despite pandemic
8 Quarterly YUPELRI Hospital Doses 53,880 34,470 47,010 54,210 56,250 70,170 78,180 93,420 97,410 K 20 K 40 K 60 K 80 K 100 K 120 K Q1'20 Q2'20 Q3'20 Q4'20 Q1'21 Q2'21 Q3'21 Q4'21 Q1'22 YUPELRI ® hospital performance accelerating despite pandemic Source: IQVIA DDD, HDS, VA and Non - Reporting Hospit
Slide 9: YUPELRI hospital sales and community TRx trends
YUPELRI ® hospital sales and community TRx trends Continued market share growth across both the hospital and retail channels 1.1% 2.2% 3.4% 5.4% 6.5% 6.6% 7.4% 7.8% 8.7% 9.5% 10.8% 11.3% 0% 5% 10% 15% 20% 25% 30% Q2'19 Q3'19 Q4'19 Q1'20 Q2'20 Q3'20 Q4'20 Q1'21 Q2'21 Q3'21 Q4'21 Q1'22 Hospital LA - N
Slide 10: TBPH implied 35% of YUPELRI US net sales by quarter
TBPH implied 35% of YUPELRI ® US net sales by quarter See TBPH 10K filed February 28, 2022 for greater detail re TBPH implied 35%. 10 TBPH implied 35% of YUPELRI US net sales represents TBPH’s portion of the combined TBPH and VIATRIS net revenue TBPH Implied 35% of Total Net Sales ($M) $3.2 $5.8 $10
Slide 11: A new focused and streamlined Theravance Biopharma
A new focused and streamlined Theravance Biopharma 1. TBPH estimate derived from integrating multiple data sources 2. TBPH holds 85% economic interest in upward - tiering royalty st ream 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
Slide 12: Ampreloxetine Phase 3 program overview
Ampreloxetine Phase 3 program overview 12 Study 0169: 4 weeks Randomized, double - blind, placebo controlled, parallel group Phase 3 Registrational Program Extension Study All patients who complete 0169 may enroll into 0170 All patients who complete 0170 may enroll into 0171 + de novo Study 0170*: 2
Slide 13: Study 0170 design and patient population
Study 0170 design and patient population NCT03829657 *n=154 planned; n =number of subjects enrolled in the randomized withdrawal period. RWD, randomized withdrawal design. 13 Disease type Placebo n=64 Ampreloxetine n=64 Total n=128* (%) Multiple system atrophy (MSA) 20 20 40 (31%) Parkinson’s diseas
Slide 14: Study 0170 pre-specified subgroup analyses: patient reported outcomes
OHDAS LS Mean Difference (95% CI) Overall (n=112) - 0.0 ( - 0.6, 0.6) MSA (n=36) - 0.8 ( - 2.1, 0.4) PD (n=58) 0.1 ( - 0.6, 0.9) PAF (n=18) 1.4 ( - 0.3, 3.0 ) Odds Ratio (95% CI) Overall (n=128 ) 0.60 (0.27, 1.29) MSA (n=40) 0.28 (0.05, 1.22) PD (n=68) 0.79 (0.26, 2.30) PAF (n=20) 0.89 (0.09, 8.41)
Slide 15: Study 0170 OHQ composite scores for MSA patients
LS Mean (95% CI) OHSA Symptom composite score - 1.6 ( - 2.7, - 0.5) Dizziness - 1.5 ( - 3.2, 0.2) Vision - 1.7 ( - 3.2, - 0.3) Weakness - 0.7 ( - 2.3, 0.9) Fatigue - 1.5 ( - 3.1, 0.1) Trouble concentrating - 1.8 ( - 3.3, - 0.4) Head/neck discomfort - 2.2 ( - 3.7, - 0.7) OHDAS Daily activities compos
Slide 16: Ampreloxetine longitudinal analysis of OHSA composite score for MSA patients
Ampreloxetine longitudinal analysis of OHSA composite score for MSA patients 16 33 34 33 33 33 33 31 33 31 32 64 60 51 44 42 20 20 19 17 20 19 18 20 0 0 4 0 4 8 12 16 18 20 22 2 4 6 8 0169 4 - week double - blind 0170 6 - week RW period 0170 16 - week open label period Placebo, n= Ampreloxetine, n=
Slide 17: GSK's TRELEGY ELLIPTA economic interest
Economic interest GSK’s TRELEGY ELLIPTA (FF/UMEC/VI): First and only once - daily single inhaler triple therapy
Slide 18: Economic interest in GSK's TRELEGY
Economic interest in GSK’s TRELEGY 1. 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 four fiscal quarters). 75% of TRC in
Slide 19: First quarter 2022 financial highlights
First quarter 2022 financial highlights 1. Cash, cash equivalents and marketable securities. 2. Amounts include share - based compensation. 19 $147.5 million cash 1 as of March 31, 2022 ($, in thousands) Revenue: Viatris collaboration agreement $ 10,687 $ 10,385 Collaboration revenue 9 3,872 Licensi
Slide 20: Financial Guidance
Financial Guidance 20 Reiterating 2022 OPEX guidance: – R&D: range of $45 – 55M – SG&A: range of $35 – 45M 2022 guidance includes ~$10M in non - recurring spend: – Majority in Q1 to support completion of late - stage programs – OPEX Q2 and onward will reflect recurring spend only Guidance excludes n
Slide 21: Rapid transition to a focused and streamlined Theravance Biopharma
Rapid transition to a focused and streamlined Theravance Biopharma 21 Significant cost reduction program reduces Company size to become sustainably cash - flow positive beginning 2H 2022 Focus on leveraging expertise in developing and commercializing respiratory therapeutics Streamlined R&D investme
Slide 22: Q&A Session
Q&A Session Rick E Winningham Chairman and Chief Executive Officer Andrew A. Hindman Senior Vice President, Chief Financial Officer Rhonda F. Farnum Senior Vice President, Chief Business Officer Richard A. Graham Senior Vice President, Research and Development
Slide 23: 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
Slide 24: 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