Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Q2 2022 Earnings Presentation
26 slides from Theravance Biopharma's earnings presentation, Aug 4, 2022
Slide 1: Second Quarter 2022 Financial Results and Business Update
Second Quarter 2022 Financial Results and Business Update August 4, 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 pa
Slide 2: Forward-looking statements
Forward - looking statements This presentation contains certain "forward - looking" statements as that term is defined in the Private Securities Litigation Ref orm Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events. Theravance B
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: Theravance Biopharma transformed and focused
Theravance Biopharma transformed and focused 4 Focused on specialized respiratory and rare neurological therapeutics Streamlined development investment to focus on ampreloxetine Leverage partnerships to unlock value of pipeline assets Overarching goal: maximize shareholder value
Slide 5: 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 6: 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 7: 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%. 7 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) $5.8 $10.4 $12
Slide 8: YUPELRI hospital performance continues strong growth
8 YUPELRI ® hospital performance continues strong growth Source: IQVIA DDD, HDS, VA and Non - Reporting Hospital through 6/30/2022. Quarterly YUPELRI Hospital Doses 53,880 34,320 46,950 54,150 56,130 70,050 78,090 93,360 97,500 107,670 K 20 K 40 K 60 K 80 K 100 K 120 K Q1'20 Q2'20 Q3'20 Q4'20 Q1'21
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 2.2% 3.4% 5.4% 6.5% 6.6% 7.4% 7.8% 8.7% 9.5% 10.8% 11.3% 11.9% 0% 5% 10% 15% 20% 25% 30% Q3'19 Q4'19 Q1'20 Q2'20 Q3'20 Q4'20 Q1'21 Q2'21 Q3'21 Q4'21 Q1'22 Q2'22 Hospital LA -
Slide 10: YUPELRI Phase 4 PIFR-2 study design
Randomization 1:1 Q1’23 Results YUPELRI SPIRIVA ® via HH* Once - daily treatment: 12 weeks N=366 Run - in YUPELRI ® : Phase 4 randomized, double - blind, parallel - group study (PIFR - 2) Endpoints ‣ Primary: Change from baseline in trough FEV 1 on Day 85 ‣ Key secondary: Trough overall treatment ef
Slide 11: Ampreloxetine (TD-9855)
Ampreloxetine (TD - 9855) Investigational once - daily norepinephrine reuptake inhibitor for symptomatic neurogenic orthostatic hypotension in m ultiple system atrophy patients
Slide 12: Commercial opportunity for ampreloxetine in MSA
Commercial opportunity for ampreloxetine in MSA 1. 2019 IQVIA Claims Analysis; NIH . 2. Symptoms associated with orthostatic hypotension in pure autonomic failure and multiple systems atrophy CH Mathias, Journa l o f Neurology (1999); ODD Analysis. 3. Data on file. MOA, mechanism of action; MSA, mul
Slide 13: Ampreloxetine mechanism of action
Untreated nOH NE Release Systolic Blood Pressure Ampreloxetine mechanism of action 1. Palma JA, Kaufmann H. Mov Disord Clin Pract 2017;4:298 - 308. NE, norepinephrine; NET, norepinephrine transporters. 13 Vasodilation Blood pressure Vasoconstriction Blood pressure Syncope Normal x Increased standing
Slide 14: Ampreloxetine increases norepinephrine, prevents blood pressure drop in MSA
Ampreloxetine increases norepinephrine, prevents blood pressure drop, and prevents symptoms worsening in MSA 1. Data from MSA patients. Error bars represent SE. * p < 0.05 comparison to baseline reported after 4 weeks of ampreloxetine administration in study 0169. 2. Data from MSA patients at week 6
Slide 15: Sale of Economic interest
Sale of Economic interest GSK’s TRELEGY ELLIPTA (FF/UMEC/VI): Once - daily single inhaler triple therapy
Slide 16: Delivering Strategic Value of 85% TRELEGY ELLIPTA Interest
Delivering Strategic Value of Theravance Biopharma’s 85% TRELEGY ELLIPTA Interest 1 1. All of its units in Theravance Respiratory Company, LLC. 2. 85 % of TRELEGY ELLIPTA royalties return to Theravance Biopharma beginning July 1, ௗ 2029 ௗ for sales ex - U.S., and January 1, ௗ 2031 ௗ for sales within
Slide 17: Second quarter 2022 financial highlights
Second quarter 2022 financial highlights $ 132.9 million cash 1 as of June 30 , 2022 1. Cash, cash equivalents and marketable securities. 2. Amounts include share - based compensation. 3. Represents legal expenses related to the TRC sale to Royalty Pharma in July 2022. 17 ($, in thousands) Revenue:
Slide 18: Financial Guidance
Financial Guidance ‣ 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 Q3 and onward will reflect recurring spend only ‣ Guidance exclude
Slide 19: Theravance Biopharma transformed and focused
Theravance Biopharma transformed and focused 19 Focused on specialized respiratory and rare neurological therapeutics Streamlined development investment to focus on ampreloxetine Leverage partnerships to unlock value of pipeline assets Overarching goal: maximize shareholder value
Slide 20: 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 21: YUPELRI 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 22: 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
Slide 23: Appendix
Appendix August 4, 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 trademarks used herein are the property of th
Slide 24: Symptomatic nOH Treatment Landscape
Symptomatic nOH Treatment Landscape 1. 2019 IQVIA Claims Analysis; NIH. 2. Symptoms associated with orthostatic hypotension in pure autonomic failure and multip le systems atrophy CH Mathias, Journal of Neurology (1999); ODD Analysis. 3. Primary readout of RESTORE study expected in 2022. 4. Reflects
Slide 25: Theravance Biopharma transformed and focused
Theravance Biopharma transformed and focused Delivering TRELEGY ELLIPTA’s strategic value, providing capital that enables: FDA, U.S. Food and Drug Administration; MSA, multiple system atrophy; NDA, new drug application. ‣ Well - capitalized : estimated cash balance of ~ $430M before implementation o
Slide 26: TRELEGY ELLIPTA Royalty Pharma Deal Summary
TRELEGY ELLIPTA Theravance Biopharma and Royalty Pharma Deal Summary ‣ Upfront: $1.1B ‣ Milestones: Up to $250M 26 1. If both milestones are achieved in a given year, Theravance Biopharma will only earn the higher milestone. 2. Based on 100% of TRELEGY ELLIPTA royalties. 3. U.S. royalties expected t