Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Q3 2024 Earnings Presentation
45 slides from Theravance Biopharma's earnings presentation, Nov 12, 2024
Slide 1: Third Quarter 2024 Financial Results and Business Update
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 owners.
Slide 2: Forward Looking Statements
2 Forward Looking Statements This presentation contains certain "forward - looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events . Theravance B
Slide 3: Agenda
3 Agenda Welcome / Opening Remarks Rick Winningham : Chief Executive Officer YUPELRI ® / Commercial Update Rhonda Farnum: Senior Vice President, Chief Business Officer Ampreloxetine Update Dr. Áine Miller: Senior Vice President, Development Financial Update Closing Remarks / Q&A Aziz Sawaf: Senior V
Slide 4: Strategic Objectives: Q3 2024 Progress
4 Strategic Objectives: Q3 2024 Progress 1. In the US, Viatris is leading the commercialization of YUPELRI, and Theravance Biopharma co - promotes the product under a profit and loss sharing a rrangement (65% to Viatris ; 35% to Theravance Biopharma). 2. Source: Viatris Customer Demand (Q3’24) . 3 .
Slide 5: Initiatives to Unlock Shareholder Value
5 Initiatives to Unlock Shareholder Value 5 • Separated roles of Chair of the Board and Chief Executive Officer • Elected Susannah Gray as Chair of the Board • Ms. Gray brings more than 30 years of biopharmaceutical experience specifically in corporate finance and capital markets roles, most recentl
Slide 6: The Only Once-Daily, Nebulized LAMA Maintenance Medicine for COPD
The Only Once - Daily, Nebulized LAMA Maintenance Medicine for COPD Co - promotion agreement with VIATRIS TM (35% / 65% Profit Share) Rhonda Farnum Senior Vice President, Chief Business Officer COPD, chronic obstructive pulmonary disease; LAMA, long - acting muscarinic antagonist
Slide 7: YUPELRI US Net Sales Performance
7 YUPELRI ® US Net Sales Performance In the US, Viatris is leading the commercialization of YUPELRI, and Theravance Biopharma co - promotes the product under a profit and loss sharing arrangement (65% to Viatris ; 35% to Theravance Biopharma). $16.5 $29.6 $36.8 $30.3 $37.0 $38.7 $36.9 $41.8 $39.4 $4
Slide 8: US Hospital Growth a Significant Contributor to Overall Performance
8 US Hospital Growth a Significant Contributor to Overall Performance Source: IQVIA DDD, HDS, VA and Non - Reporting Hospital through Sep’24. Preliminary data subject to revision upon receipt of final data. 19 K 30 K 54 K 34 K 47 K 54 K 56 K 70 K 78 K 93 K 98 K 108 K 113 K 138 K 163 K 158 K 162 K 19
Slide 9: YUPELRI Market Share Trends
9 YUPELRI ® Market Share Trends 1. Joint VTRS/TBPH Market Research (Jun’24). * Hospital LA - NEB Market Share - IQVIA DDD through Sep’24. †Community LA - NEB Market Share includes Retail + DME / Med B FFS through Aug’24. 9 10.8% 11.3% 11.6% 13.3% 12.4% 15.0% 15.2% 16.1% 16.7% 16.6% 18.2% 18.9% 0% 5%
Slide 10: The YUPELRI China Opportunity
10 The YUPELRI ® China Opportunity NDA Filed June 2024 Viatris is the 8 th largest multinational company in China, with a sales force of ~4,200 covering >70K hospitals and 400K pharmacies in over 300 cities 5 #2 pharmaceutical market globally 1 Nearly 100M individuals with COPD; ~43% suffer from mod
Slide 11: YUPELRI Value Proposition
11 Once - Daily Nebulized LAMA COPD Maintenance Medicine o Medicare Part B therapy; FFS beneficiaries with supplemental insurance face out - of - pocket costs as low as $0 1 o Last twelve months’ US sales up 8% to $233M; Theravance receives 35% of US profits 2 o Brand profitable, with expanding marg
Slide 12: TRELEGY ELLIPTA: Milestone and Royalty Agreement with Royalty Pharma
The First And Only Once - Daily Triple Therapy In a Single Inhaler For Adult Patients With COPD Or Asthma Milestone and royalty agreement with Royalty Pharma Aziz Sawaf Senior Vice President, Chief Financial Officer GSK’s TRELEGY COPD, chronic obstructive pulmonary disease
Slide 13: $200M in Potential TRELEGY Sales Milestones
13 $200M in Potential TRELEGY Sales Milestones if Upper Tier Thresholds are Met 1. If both milestones are achieved in a given year, Theravance Biopharma will only earn the higher milestone. As of 09/30/24, Th eravance stands to receive up to $200 million in TRELEGY sales milestones paid directly fro
Slide 14: Global TRELEGY Royalties to Return Beginning in 2029
14 Global TRELEGY Royalties to Return Beginning in 2029 1. Eligibility generally ends 15 years after first launch in an eligible territory: U.S. royalties are expected to end late 2 032 , while ex - U.S. royalties are expected to end in the mid - 2030s on a country - by - country basis. 2. Total roy
Slide 15: Ampreloxetine
The first once - daily, selective norepinephrine reuptake inhibitor in development to treat symptomatic nOH in MSA Dr. Áine Miller Senior Vice President, Development MSA, multiple system atrophy; nOH , neurogenic orthostatic hypotension AMPRELOXETINE
Slide 16: Ampreloxetine Update
16 Ampreloxetine Update CYPRESS Study: o Significant progress activating remaining key Academic Centers / Centers of Excellence o Enrollment consistent with projections, with development timelines on track 1. Long - term safety of ampreloxetine in patients with symptomatic neurogenic orthostatic hyp
Slide 17: Ampreloxetine Value Proposition in MSA with nOH
17 Ampreloxetine Value Proposition in MSA with nOH Significant unmet medical need o Rare disease with ~40,000 patients in the United States and significant unmet need ex - US 1,2,3 o Commonly used agents rarely work in MSA and face important safety and tolerability limitations 4,5 Differentiated fir
Slide 18: Financial Update
Financial Update Aziz Sawaf Senior Vice President, Chief Financial Officer
Slide 19: Third Quarter 2024 Financials (Unaudited)
19 Third Quarter 2024 Financials (Unaudited) 1. Amounts include share - based compensation. 2. Non - GAAP net profit (loss) from continuing operations consists of GAAP net loss before taxes excluding share - based compensation expense, non - cash interest expense and non - cash impairment expense; s
Slide 20: Third Quarter 2024 Financials (Cont'd)
20 Third Quarter 2024 Financials (Unaudited) (Cont’d) 20 See the section titled "Non - GAAP Financial Measures" on Slide 2 for more information. GAAP Net Loss $ (12,698) $ (8,950) $ (40,891) $ (46,683) Adjustments: Share-based compensation expense 4,963 6,262 15,567 19,547 Non-cash impairment of lon
Slide 21: Q3 2024 Financial Highlights
21 Q3 2024 Financial Highlights 1. Non - GAAP net profit (loss) from continuing operations consists of GAAP net income (loss) before taxes less share - based compen sation expense, non - cash interest expense, and non - cash impairment expense; see reconciliation on Slide 20 and the section titled "
Slide 22: 2024 Financial Guidance
22 2024 Financial Guidance 1. Non - GAAP net profit (loss) from continuing operations is expected to consist of GAAP net income (loss) before taxes less shar e - based compensation expense, non - cash interest expense and non - cash impairment expense; the section titled “Non - GAAP Financial Measur
Slide 23: Summary: Theravance's Strategic Priorities
23 Maximize Value for Shareholders Complete Pivotal Phase 3 in Patients with MSA and nOH Devastating rare neurological disorder causing unremitting symptoms of autonomic failure in ~80% of patients 2,3 Ampreloxetine : p otential first - in - class agent may be uniquely tailored to mitigate these sym
Slide 24: Q&A Session
Rick Winningham Chief Executive Officer Aziz Sawaf, CFA Senior Vice President, Chief Financial Officer Rhonda Farnum Senior Vice President, Chief Business Officer Áine Miller Senior Vice President, Development Q&A Session
Slide 25: YUPELRI (revefenacin) Inhalation Solution
25 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 26: About YUPELRI (revefenacin) Inhalation Solution
26 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
Slide 27: Appendix I: YUPELRI
Appendix I: YUPELRI®
Slide 28: YUPELRI Opportunity: Expand Use of Neb LAMA in ~1.9M COPD Patients
28 YUPELRI Opportunity: Expand Use of Neb LAMA in ~1.9M COPD Patients 1 1. Addressable patient population quantifies the number of patients within the intended target profile. Source: Citeline Mark et Research (Jun’23). 2. Global Initiative for Chronic Obstructive Lung Disease 2024 Report. 3. Medica
Slide 29: Theravance / Viatris Partnership Drives YUPELRI Prescription Growth
29 Theravance / Viatris Partnership Drives YUPELRI Prescription Growth US Co - Promotion Agreement (35% / 65% Profit Share) Community (Doctor’s Office) Hospital MD starts YUPELRI Community MD starts YUPELRI Hospital starts make a sizeable contribution to the business • >80% of patients receiving YUP
Slide 30: Appendix II: ampreloxetine
Appendix II: ampreloxetine
Slide 31: Multiple System Atrophy: A Progressive Neurological Disorder
31 Multiple System Atrophy (MSA): A progressive neurological disorder leading to autonomic failure and neurogenic orthostatic hypotension ( nOH ) Sources: Biorender.com. In MSA , abnormal deposits of mis - folded - synuclein are associated with progressive neuro - degeneration Neuro - degeneration l
Slide 32: Neurogenic Orthostatic Hypotension: One of the Most Devastating Consequences of MSA
32 Neurogenic Orthostatic Hypotension ( nOH ): One of the Most Devastating Consequences of MSA 1. 203202ORIG1S000 - FDA, www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203202Orig1s000SumR.pdf. Accessed 8 Sept. 2024. 2. Kau fmann H. (2023, November 15 - 18). Evaluating clinically meaningful changes
Slide 33: Ampreloxetine Intended to Increase Norepinephrine and Treat nOH
33 Ampreloxetine Intended to Increase Norepinephrine and Treat nOH Post - ganglionic sympathetic nerve Pre - ganglionic sympathetic nerve Autonomic ganglia NE Post - ganglionic Sympathetic Nerve ending NET NE VMAT Effector Cell NET Sympathetic activity ( NE released into the synapse) stimulates adre
Slide 34: Durable, Clinically-Significant Symptom Improvements Seen in MSA Patients
34 Durable, Clinically - Significant Symptom Improvements Seen in MSA Patients CI, confidence interval; DB, double - blind; MSA, multiple system atrophy; OHSA, orthostatic hypotension symptom assessment; OL, o pen label; RW, randomized withdrawal. BL1 2 3 4 0 2 4 6 8 BL 4 8 12 16 BL 18 20 22 time (w
Slide 35: Consistent Symptom Benefits Across Individual OHSA Items
35 Consistent Symptom Benefits Across Individual OHSA Items in MSA Patients Data from MSA patients at week 6 of the randomized withdrawal period of study 0170; individual item score analyses are post - hoc, except for dizziness. CI, confidence interval; LS, least squares; MSA, multiple system atroph
Slide 36: Ampreloxetine Prevented Worsening of Standing SBP in MSA Patients
36 -40 -20 0 20 40 60 M e a n C h a n g e , m m H g ( S D ) Supine SBP No Difference + 1.6 + 0.5 Ampreloxetine Prevented Worsening of Standing SBP in MSA Patients with No Impact on Supine SBP • Standing blood pressure improvement of 18.5 mmHg compared to placebo during randomized withdrawal phase •
Slide 37: CYPRESS Designed to Reproduce Study 0170 MSA Patient Results
37 CYPRESS Designed to Reproduce Study 0170 MSA Patient Results MSA, multiple system atrophy; nOH , neurogenic orthostatic hypotension; OHSA, orthostatic hypotension symptom assessment; RW, randomized withdrawal. Entry Endpoint 8 - week double blind RW 12 - week open - label Baseline Randomization A
Slide 38: Alignment with FDA on CYPRESS Trial Design and Regulatory Approach
38 Alignment with FDA on CYPRESS Trial Design and Regulatory Approach 1. Kaufmann H. (2023, November 15 - 18). Evaluating clinically meaningful changes in the Orthostatic Hypotension Symptom Assessmen t domain of the Orthostatic Hypotension Questionnaire. [Poster presentation]. OHSA, orthostatic hyp
Slide 39: Ampreloxetine Global Opportunity
39 Prevalence in Europe 1,2 45 - 60K MSA Patients with nOH Prevalence in China & Japan 1 90 - 105K MSA Patients with nOH Ampreloxetine Global Opportunity Significant unmet needs in leading therapeutics markets 1. Thelansis nOH Market Report 2023; TBPH Internal Analysis. nOH graphics reflect the mid
Slide 40: The Unmet Need in MSA Patients with nOH is High
40 The Unmet Need in MSA Patients with nOH is High 1. Claassen D.O., Adler C.H., Hewitt L.A., Gibbons C. (2018), BMC Neurology, 18 (1), art. no. 125. MSA, multiple system atrophy; nOH neurogenic orthostatic hypotension. Advocacy groups, patients and caregivers are actively engaged and seeking new th
Slide 41: MSA Patients with nOH are Not Optimally Treated
41 MSA Patients with nOH are Not Optimally Treated Clinically meaningful options are needed 1. MSA Natural History Statistics, NYU September 2019. 2. Veeva Compass patient - level claims data, MSA patients (G90.3) with at least 1 Rx from 2020 - 2023. Product share defined as total “days supplied” in
Slide 42: Concentrated Treatment Landscape, Centered on MSA, nOH Specialists
42 Concentrated Treatment Landscape, Centered on MSA, nOH Specialists 1. Centers of Excellence: https://missionmsa.org/resource - library/centers - of - excellence - overview/ , https://www.psp.org/centers - of - care , accessed Nov 5, 2024 2. Veeva Compass patient - level claims data, MSA patients
Slide 43: MSA Patients with nOH Suffer Worse Symptom Burden and Daily Functioning
43 MSA Patients with nOH Suffer Worse Symptom Burden and Daily Functioning Impact of symptomatic neurogenic orthostatic hypotension ( nOH ) on symptom burden and daily functioning in patients with alpha synucleinopathies . V Iodice , T Guerin, S Johnstone, L Norcliffe - Kaufmann, A Miller, R Vickery
Slide 44: Appendix III: Corporate / Other
Appendix III: Corporate / Other
Slide 45: Granted Patent Protection into Late 2030s
45 Granted Patent Protection into Late 2030s COPD, chronic obstructive pulmonary disease; nOH , neurogenic orthostatic hypotension; PTE, patent term extensions. Estimated Patent Expiry Invention Compound 2028 Composition of Matter YUPELRI ® / revefenacin 2030 - 2031 Polymorph 2039 Method for the mai