Financial Data and Key Metrics Changes - In Q4 2024, YUPELRI net sales increased by 10% year-over-year, reaching $66.7 million, marking an all-time high [4] - Full year YUPELRI sales totaled $239 million, with an 8% increase in net sales for 2024 and an 11% growth in demand [11][14] - Collaboration revenue grew by 8% to approximately $19 million in Q4 [32] - Operating expenses, excluding share-based compensation, increased to $22 million due to commercial and medical affairs spending [32] Business Line Data and Key Metrics Changes - YUPELRI's hospital performance saw doses increase by 49% year-over-year, with 285,000 redoses pulled through to hospital customers [12][13] - The hospital business accounts for roughly 10% of total YUPELRI volume, with the remaining 90% coming from community settings [77] - Ampreloxetine is on track for expedited NDA filing, with solid enrollment in the CYPRESS study and positive FDA interactions [5][23] Market Data and Key Metrics Changes - GSK reported full year TRELEGY sales of $3.5 billion, up 26% year-over-year, triggering a $50 million milestone payment to Theravance [15] - The company expects to receive several hundred million in cumulative royalties starting in 2029 based on projected sales [17] Company Strategy and Development Direction - The company aims to grow YUPELRI revenue while increasing brand profitability, with potential near-term milestones in the U.S. and royalties from China [7][14] - There is a focus on completing enrollment in the CYPRESS study and preparing for an expedited NDA filing for ampreloxetine [8][23] - The company is committed to maximizing the value of TRELEGY and returning excess capital to shareholders [9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong financial position entering 2025, with $88 million in cash and no debt [39] - The company is focused on driving YUPELRI growth through strong demand generation and a patient-centered strategy [40] - Management highlighted the potential impact of ampreloxetine on patients with MSA suffering from nOH symptoms [41] Other Important Information - The company plans to request priority review for ampreloxetine at the time of NDA filing [23] - The accounting treatment for TRELEGY milestones has been updated, affecting the recognition of other income [37] Q&A Session Summary Question: What drove the success on the hospital channel this quarter? - Management attributed the success to effective execution of strategy and wins in larger systems, leading to increased volume through therapeutic interchange [45][46] Question: What is the trajectory of the hospital performance into 2025? - Management noted that Q1 is typically softer but indicated that the need for YUPELRI is strong due to high hospital census [59][60] Question: What percentage of YUPELRI sales are non-hospital sales dollars? - Management clarified that the hospital business accounts for roughly 10% of total YUPELRI volume, with 90% from community settings [77] Question: What is the bar for success for the CYPRESS readout? - A one-point change in the OHSA composite score is considered clinically meaningful for success [88] Question: Will there be an increase in the commercial organization ahead of the data? - Management stated that no incremental FTEs are planned until after the CYPRESS data readout [93]

Financial Data and Key Metrics Changes - In Q4 2024, YUPELRI net sales increased by 10% year-over-year, reaching $66.7 million, marking an all-time high [4] - Full year YUPELRI sales totaled $239 million, with an 8% increase in net sales for 2024 and an 11% growth in demand [11][14] - Collaboration revenue grew by 8% to approximately $19 million in Q4 [32] - Operating expenses, excluding share-based compensation, increased to $22 million due to higher commercial and medical affairs spending [32] Business Line Data and Key Metrics Changes - YUPELRI's hospital performance saw doses increase by 49% year-over-year, with 285,000 redoses pulled through to hospital customers [4][13] - The hospital business accounts for roughly 10% of total YUPELRI volume, with 90% coming from community settings [77] - Ample enrollment in the CYPRESS study for ampreloxetine is on track, with expectations for expedited NDA filing [5][20] Market Data and Key Metrics Changes - TRELEGY reported full year sales of $3.5 billion, up 26% year-over-year, triggering a $50 million milestone payment [15] - The company anticipates achieving an additional $150 million in milestones from TRELEGY in 2025 and 2026 [16] Company Strategy and Development Direction - The company aims to grow YUPELRI revenue while increasing brand profitability, with potential near-term sales milestones in the U.S. and royalties from China [7] - For ampreloxetine, the focus is on completing enrollment in the CYPRESS study and preparing for an expedited NDA filing [8] - The company is committed to maximizing the value of TRELEGY and returning excess capital to shareholders [9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the financial position entering 2025, with $88 million in cash and no debt [39] - The company is focused on driving YUPELRI growth through strong demand generation and a patient-centered strategy [40] - Management highlighted the potential impact of ampreloxetine on patients with MSA suffering from nOH symptoms [41] Other Important Information - The company completed market research indicating a significant unmet need for better nOH therapies, with over 70% of surveyed neurologists agreeing [25] - The target product profile for ampreloxetine aligns with physician preferences, suggesting a favorable outlook if approved [28] Q&A Session Summary Question: What drove the success in the hospital channel this quarter? - The success was attributed to effective execution of strategy and wins in larger systems, with therapeutic interchange contributing to increased volume [45][46] Question: What is the trend for the hospital performance into 2025? - Q1 is typically softer, but there is a demonstrated need for YUPELRI, which may provide a tailwind [60] Question: What are the next steps for YUPELRI in China? - The company is waiting for regulatory feedback from Viatris, with a typical two-year window expected from submission to approval [62] Question: What was the nature of the recent FDA feedback on ampreloxetine? - The feedback was from a Type C meeting to clarify filing content and ensure alignment on key requirements for full approval [67] Question: What percentage of YUPELRI sales are non-hospital sales? - The hospital business accounts for roughly 10% of total YUPELRI volume, with the community setting making up the majority [77] Question: What is the bar for success for the CYPRESS readout? - A one-point change in the OHSA composite score is considered clinically meaningful for success [88]

Theravance Biopharma Fourth Quarter & Full Year 2024 Financial Results and Business Update February 26, 2025 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. © 2025 Theravance Biopharma. All rights reserved. Forward Looking Statements This presentation contains certa ...

分组1 - Theravance Biopharma reported a quarterly loss of $0.05 per share, consistent with the Zacks Consensus Estimate, compared to earnings of $0.03 per share a year ago [1] - The company posted revenues of $18.75 million for the quarter ended December 2024, exceeding the Zacks Consensus Estimate by 3.50% and up from $17.57 million year-over-year [2] - Over the last four quarters, Theravance Biopharma has surpassed consensus EPS estimates two times and revenue estimates two times [2][1] 分组2 - The stock has underperformed, losing about 4.7% since the beginning of the year, while the S&P 500 gained 1.3% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.12 on revenues of $17.65 million, and for the current fiscal year, it is $0.84 on revenues of $111.23 million [7] - The Zacks Industry Rank for Medical - Drugs is in the top 50% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8]

Financial Performance - Theravance Biopharma reported record Q4 2024 net sales of YUPELRI at $66.7 million, an increase of 10% year-over-year, and total FY 2024 net sales of $238.6 million, up 8% compared to 2023[6]. - FY 2024 TRELEGY global net sales reached $3.46 billion, a 26% increase from 2023, triggering a $50 million milestone payment to Theravance Biopharma[6][8]. - Total revenue for Q4 2024 was $18,754,000, an increase from $17,565,000 in Q4 2023, representing a growth of 6.8%[32]. - YUPELRI net sales recorded by Viatris for Q4 2024 were $66,680,000, compared to $60,644,000 in Q4 2023, indicating a year-over-year increase of 9.4%[32]. Expenses - R&D expenses for Q4 2024 were $9.5 million, compared to $8.3 million in Q4 2023, while SG&A expenses increased to $18.5 million from $15.5 million in the same period[12]. - The company expects full-year 2025 R&D expenses to be between $32 million and $38 million, and SG&A expenses to be between $50 million and $60 million, excluding share-based compensation[18]. - Research and development expenses for Q4 2024 were $9,452,000, up from $8,314,000 in Q4 2023, marking an increase of 13.7%[32]. - Selling, general and administrative expenses for Q4 2024 totaled $18,502,000, compared to $15,492,000 in Q4 2023, an increase of 19.5%[32]. Net Loss - Theravance Biopharma's net loss for Q4 2024 was $15.5 million, compared to a net loss of $8.5 million in Q4 2023, with a non-GAAP net loss of $2.5 million[12]. - The net loss for Q4 2024 was $15,528,000, compared to a net loss of $8,511,000 in Q4 2023, reflecting a deterioration of 82.5%[32]. - Non-GAAP net loss for Q4 2024 was $2,472,000, a decrease from a non-GAAP net income of $1,431,000 in Q4 2023[35]. Cash and Assets - The company ended Q4 2024 with $88 million in cash, excluding the $50 million TRELEGY milestone, with cash receipt expected in February 2025[6]. - Cash and cash equivalents decreased to $88,350,000 as of December 31, 2024, down from $102,426,000 as of December 31, 2023, a decline of 13.8%[30]. - Total current assets increased to $161,067,000 as of December 31, 2024, compared to $133,541,000 as of December 31, 2023, representing a growth of 20.6%[30]. - Future contingent milestone and royalty assets decreased to $144,200,000 as of December 31, 2024, down from $194,200,000 as of December 31, 2023, a decline of 25.8%[30]. - Shareholders' equity decreased to $175,545,000 as of December 31, 2024, compared to $212,995,000 as of December 31, 2023, a decrease of 17.6%[30]. Strategic Initiatives - Theravance Biopharma formed a Strategic Review Committee to assess strategic alternatives aimed at unlocking shareholder value[10]. - The CYPRESS study is on track to enroll the final patient in mid-2025, with top-line data anticipated approximately six months later[9]. - Ampreloxetine, an investigational drug for symptomatic neurogenic orthostatic hypotension, is preparing for an expedited NDA filing post-CYPRESS readout[9][16]. Market Demand - Customer demand for YUPELRI grew by 9% in Q4 2024 compared to Q3 2024, and doses sold into the hospital channel increased by 49% year-over-year[9].

Core Insights - Theravance Biopharma reported strong financial and operational results for Q4 and FY 2024, highlighting record net sales for YUPELRI and significant milestones related to TRELEGY [2][4][5] Financial Performance - Q4 2024 US net sales for YUPELRI reached $66.7 million, a 10% increase year-over-year, while FY 2024 total US net sales were $238.6 million, up 8% compared to 2023 [4][5] - Global net sales for TRELEGY in Q4 2024 were $853 million, marking a 16% increase, and $3.46 billion for FY 2024, a 26% increase year-over-year, triggering a $50 million milestone payment to Theravance Biopharma [3][4][5] - Total revenue for Q4 2024 was $18.8 million, entirely from Viatris collaboration revenue, which increased by 8% compared to Q4 2023 [9] Research and Development - R&D expenses for Q4 2024 were $9.5 million, compared to $8.3 million in Q4 2023, with full-year R&D expenses of $32.5 million falling within the guidance range [9][10] - The CYPRESS study is on track to enroll the final patient by mid-2025, with top-line data expected approximately six months later [4][5] Strategic Initiatives - The company formed a Strategic Review Committee to explore alternatives for unlocking shareholder value [7] - Theravance Biopharma is preparing for an expedited NDA filing post-CYPRESS readout and has received confirmation from the FDA regarding the content of a complete application [5][10] Market Position and Future Outlook - The company anticipates continued growth in YUPELRI sales, with a potential $25 million milestone payment from Viatris if YUPELRI achieves at least $250 million in US net sales in 2025 [5][10] - Royalties of up to 8.5% on TRELEGY net sales will return to Theravance Biopharma in eligible territories starting mid-2029, contributing to long-term value [5][10]

Core Viewpoint - Theravance Biopharma, Inc. is set to report its fourth quarter and full year 2024 financial results on February 26, 2025, along with a business update [1] Company Overview - Theravance Biopharma focuses on delivering impactful medicines, leveraging decades of expertise [3] - The company has developed the FDA-approved YUPELRI® (revefenacin) inhalation solution for chronic obstructive pulmonary disease (COPD) [3] - Ampreloxetine, a late-stage investigational drug, is being developed for symptomatic neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA) [3] - The company aims to create and drive shareholder value [3]

Company Overview - Theravance Biopharma (TBPH) shares increased by 8.3% to $10.47 in the last trading session, contrasting with a 1.9% loss over the past four weeks [1] - The company has developed Yupelri, a nebulized treatment for chronic obstructive pulmonary disease, in collaboration with Viatris [2] - Theravance is also advancing ampreloxetine in late-stage studies for treating neurogenic orthostatic hypotension in patients with multiple system atrophy [2] Financial Performance - The company is expected to report a quarterly loss of $0.05 per share, reflecting a year-over-year change of -266.7% [3] - Revenues are anticipated to be $35.19 million, representing a 100.3% increase from the same quarter last year [3] - The consensus EPS estimate for the quarter has remained unchanged over the last 30 days [4] Market Sentiment - The recent share price rally may be attributed to growing optimism regarding pipeline progress and the uptake of Yupelri [2] - A strong correlation exists between trends in earnings estimate revisions and near-term stock price movements, indicating the importance of monitoring these trends [3] - Theravance Bio currently holds a Zacks Rank of 3 (Hold), suggesting a neutral outlook [4]

Company Overview - Theravance Biopharma, Inc. focuses on delivering Medicines that Make a Difference® in people's lives [2] - The company has developed the FDA-approved YUPELRI® (revefenacin) inhalation solution for the maintenance treatment of chronic obstructive pulmonary disease (COPD) [2] - Ampreloxetine, a late-stage investigational drug, is being developed for symptomatic neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA) and has the potential to be a first-in-class therapy [2] Upcoming Events - Theravance Biopharma's management team will hold investor meetings during the 43rd Annual J.P. Morgan Healthcare Conference from January 13-16, 2025, in San Francisco, CA [1]

Company Overview - Theravance Biopharma reported a narrower adjusted net loss of 6 cents per share for Q3 2024, compared to the Zacks Consensus Estimate of a loss of 10 cents, and a loss of 1 cent per share in the same quarter last year [2][3] - The total revenues for the quarter were $16.9 million, exceeding the Zacks Consensus Estimate of $16 million, and representing an 8% year-over-year increase driven by collaboration revenues from Viatris [3] Financial Details - The reported loss of 26 cents per share includes share-based compensation, non-cash impairment of long-lived assets, income tax expense, and non-cash interest expense, compared to a loss of 17 cents in the year-ago quarter [3] - Research and development expenses (excluding share-based compensation) were $8.2 million, up nearly 30% from the previous year, while selling, general and administrative expenses increased around 10% year-over-year to $13 million [4] Cash Position and Guidance - As of September 30, 2024, Theravance had cash, cash equivalents, and marketable securities totaling $91.4 million, down from $96.1 million as of June 30, 2024 [5] - The company expects adjusted R&D expenses in the range of $30-$36 million and adjusted SG&A expenses between $45 million and $55 million for 2024 [6] Market Performance and Estimates - There has been an upward trend in estimates for Theravance over the past month, with a consensus estimate shift of -43.43% [8][9] - The stock currently holds a Zacks Rank 3 (Hold), indicating an expectation of an in-line return in the coming months [12] Industry Comparison - Theravance operates within the Zacks Medical - Drugs industry, where Ionis Pharmaceuticals reported revenues of $134 million for the last quarter, reflecting a year-over-year decline of 6.9% [13] - Ionis Pharmaceuticals is expected to post a loss of $1.03 per share for the current quarter, indicating a significant change from the previous year, and holds a Zacks Rank 2 (Buy) [14]