Core Insights - Theravance Biopharma announced new analyses supporting the efficacy and safety of ampreloxetine for treating symptomatic neurogenic orthostatic hypotension (nOH) at the 77th Annual Meeting of the American Academy of Neurology [1][2] Group 1: Efficacy of Ampreloxetine - The Phase 3 program included two trials focusing on patients with nOH due to multiple system atrophy (MSA), Parkinson's Disease, and pure autonomic failure, with ongoing studies supporting its potential for registration [2][3] - In Study 0169, patients treated with ampreloxetine showed a mean increase of 58% in venous plasma norepinephrine levels after 4 weeks, with a 79% increase in MSA patients [6][12] - The pharmacodynamic effects demonstrated durable target engagement and a physiological effect on blood pressure, particularly in MSA patients [2][6] Group 2: Safety Profile - Analyses indicated no worsening of supine hypertension in patients treated with ampreloxetine, a significant concern with existing therapies [5][7] - Patients on ampreloxetine did not experience increased overnight supine hypertension compared to those on placebo, suggesting a favorable safety profile [7][8] - The unique mechanism of action of ampreloxetine may allow for effective treatment of nOH without the side effects associated with high blood pressure in the supine position [8][10] Group 3: Ongoing Studies and Future Prospects - The ongoing CYPRESS study aims to evaluate the efficacy and durability of ampreloxetine in MSA patients with symptomatic nOH, with a primary endpoint focused on changes in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score [11][12] - The company plans to file a New Drug Application (NDA) for ampreloxetine if results from the ongoing studies are supportive [10][12] - The potential for ampreloxetine to become a first-in-class therapy for nOH in MSA patients is highlighted, addressing a significant unmet medical need [10][14]

It has been about a month since the last earnings report for Theravance Biopharma (TBPH) . Shares have added about 0.4% in that time frame, outperforming the S&P 500.Will the recent positive trend continue leading up to its next earnings release, or is Theravance Bio due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important drivers.How Have Estimates Been Moving Since ...

Core Insights - Theravance Biopharma is presenting new analyses of the Phase 3 program for ampreloxetine at the upcoming AAN Meeting, highlighting its selective pharmacodynamic profile [1][2] - The ongoing CYPRESS Study 197 aims to confirm the efficacy of ampreloxetine in treating neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA) [1][4] Company Overview - Theravance Biopharma focuses on developing innovative therapies, including ampreloxetine, a once-daily norepinephrine reuptake inhibitor for symptomatic nOH in MSA patients [3][9] - The company has received Orphan Drug Designation for ampreloxetine in the U.S. and plans to file a New Drug Application (NDA) if ongoing studies yield positive results [3] Clinical Study Details - The CYPRESS Study 197 is a multi-center, randomized withdrawal study evaluating the efficacy of ampreloxetine after 20 weeks of treatment, with a primary endpoint of change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score [4] - Previous studies (Study 169 and Study 170) indicated that while Study 169 did not meet its primary endpoint, a subgroup analysis suggested significant benefits for MSA patients, showing a 72% reduction in treatment failure odds with ampreloxetine [5][6] Disease Context - Multiple system atrophy (MSA) is a progressive disorder affecting movement and autonomic functions, with approximately 50,000 patients in the U.S., and 70-90% experiencing nOH symptoms [7][8] - Neurogenic orthostatic hypotension (nOH) is characterized by significant drops in blood pressure upon standing, leading to debilitating symptoms such as dizziness and fainting [8]

Financial Performance - YUPELRI net sales increased by 8% to $238.6 million in 2024 compared to 2023, with hospital volumes growing 41%[15] - TRELEGY's global net sales reached $3.46 billion in 2024, exceeding the threshold for a $50 million milestone payment[17] - The company received a $50 million milestone payment from Royalty Pharma related to TRELEGY's 2024 global net sales[17] - Total 2024 TRELEGY global net sales represented a 26% increase compared to 2023, with expectations of generating global peak sales of $4.0 billion in 2026[40] - A total of $150.0 million in potential Milestone Payments remain available, with eligibility for $25.0 million if 2025 TRELEGY global net sales reach approximately $3.06 billion[40] - YUPELRI's implied net sales share for Theravance Biopharma was $83.5 million in 2024, reflecting an 8% increase from 2023[29] - For the year ended December 31, 2024, Theravance Biopharma recognized a net loss of $56.4 million, with a cumulative net loss of $965.5 million since the spin-off from Innoviva, Inc.[117] Strategic Initiatives - The company has formed a Strategic Review Committee to assess strategic alternatives aimed at unlocking shareholder value[18] - The company completed the sale of its equity interests in Theravance Respiratory Company for approximately $1.11 billion, retaining future value through contingent milestone payments[38] - The company is undergoing a strategic review process to assess alternatives for unlocking shareholder value, which may be time-consuming and disruptive[144] - The company has incurred substantial expenses related to identifying and evaluating potential strategic alternatives, which may impact its operating results[144] Product Development and Regulatory Affairs - Ampreloxetine Phase 3 clinical study enrollment is on track for completion in mid-2025, with data expected approximately six months later[16] - Ampreloxetine has received Orphan Drug Designation from the FDA for the treatment of symptomatic nOH in MSA patients[36] - Regulatory approval processes for pharmaceutical products are extensive, requiring rigorous clinical studies and compliance with FDA standards[52] - The ability to market products outside the US depends on receiving marketing authorizations from regulatory authorities, similar to FDA approval processes[64] - Regulatory compliance is critical, as failure to meet FDA standards could lead to penalties and adversely affect the company's financial condition[153] - The FDA regulates marketing and promotion of drugs, allowing only claims consistent with approved labeling[60] - The company must navigate complex legal and regulatory environments regarding pricing and reimbursement, which could impact market acceptance and sales of its products[70] Intellectual Property - The company owns a total of 177 issued US patents and 1,070 granted foreign patents as of December 31, 2024, which are crucial for protecting its technology[76] - The patent rights for YUPELRI (revefenacin) inhalation solution include multiple US patents expiring between 2025 and 2039, providing a competitive advantage[76] - The company’s patent applications may be eligible for limited patent term extensions under the Hatch-Waxman Act, which could extend patent protection by up to five years[80] - The company has multiple patents protecting YUPELRI, with expiration dates ranging from 2025 to 2039, but faces competition from generic versions, which could significantly impact its market position[161] - The FDA has imposed a stay of approval on generic versions of YUPELRI until May 2026 due to ongoing patent infringement lawsuits[85] - As of February 28, 2025, the company has settled litigation with several generic companies, allowing them to market their generic versions of YUPELRI starting April 23, 2039[88] Market Competition - The commercial success of YUPELRI is contingent on its acceptance by physicians, patients, and third-party payors, with potential declines in revenue if acceptance does not grow[123] - The company faces substantial competition from larger firms, which may hinder its ability to discover and commercialize products successfully[118] - YUPELRI competes with short-acting nebulized bronchodilators and new products like Verona Pharma's ensifentrine and Sanofi's Dupixent, which could affect its market position[148] - The company faces substantial competition from larger companies with more resources, which may hinder its ability to successfully develop and commercialize new medicines[145] Operational Risks - The company relies on third-party contract manufacturing organizations for production, mitigating the need for internal manufacturing capacity[48] - The company relies on single-source suppliers for YUPELRI's API and drug product, posing risks if these suppliers fail to meet demand[149] - Significant disruptions to information technology systems or security breaches could adversely affect the company's operations and financial results[181] - The distribution of YUPELRI through various suppliers may be impacted by security breaches, potentially leading to reduced revenue[184] Employee and Corporate Culture - The company has 97 employees as of December 31, 2024, with 86 based in the US and 11 in Dublin, Ireland[98] - The employee engagement survey for 2024 achieved a participation rate of 96% with an average score of 4.4 out of 5[102] - The company emphasizes a culture of diversity, equity, inclusion, and belonging, supported by employee-led groups[105] - The company offers a competitive total rewards package, including base salary, cash bonuses, equity incentives, and health benefits[107] - The company has implemented workplace safety initiatives to comply with health and safety standards[111] Financial Position and Future Outlook - The company had cash, cash equivalents, and marketable securities of approximately $88.4 million as of December 31, 2024, which is expected to meet anticipated operating needs for at least the next twelve months[193] - Future capital needs will depend on various factors, including support for YUPELRI commercialization strategies and the ampreloxetine program[194] - The company may need to seek additional funding through public or private equity, debt financings, or collaborations, which could dilute current shareholders' ownership[197] - The company is vulnerable to geopolitical and economic conditions, including the ongoing war in Ukraine and inflation, which may negatively affect its operations and stock price[186] - Future tax reforms and changes in tax laws could materially impact the company's financial condition and results of operations[206] - The company may be subject to challenges regarding its tax structure and transfer pricing arrangements, which could result in increased tax liabilities[209] Compliance and Reporting - The company is subject to reporting obligations under the Exchange Act, including the requirements of Section 404 of the Sarbanes-Oxley Act of 2002[212] - Effective internal controls are crucial for the reliability of financial reporting and the preparation of financial statements[212] - Any failure to maintain effective internal controls could adversely affect the company's business, financial position, and results of operations[212] - The management is responsible for establishing and maintaining adequate internal control over financial reporting[212] - Significant demands are placed on management and operational resources due to reporting obligations[212]

Financial Performance - Theravance Biopharma reported a fourth-quarter 2024 adjusted net loss of 5 cents per share, consistent with the Zacks Consensus Estimate, compared to earnings of 3 cents per share in the same quarter last year [1] - Total revenues for the quarter were $18.8 million, slightly exceeding the Zacks Consensus Estimate of $18.0 million, and reflecting a year-over-year increase of 6.8% due to higher collaboration revenues from partner Viatris [3] - The reported loss, including share-based compensation, income tax expense, and non-cash interest expense, was 31 cents per share, compared to a loss of 17 cents in the year-ago quarter [2] Collaboration and Revenue Sources - The revenue was entirely derived from Viatris' collaboration revenues related to Yupelri (revefenacin) sales, which increased by 8% year over year in the fourth quarter [4] - Viatris recorded U.S. net sales of Yupelri at $66.7 million, marking a 10% year-over-year increase [6] - Viatris retains 65% of the profits from Yupelri sales, while Theravance receives 35%, which includes its share of net sales and proportionate costs [5] Expenses and Financial Guidance - Research and development expenses (excluding share-based compensation) totaled $8.1 million, up nearly 23% from the previous year, while selling, general, and administrative expenses increased around 23% year over year to $14.1 million [9] - For 2025, Theravance expects adjusted R&D expenses to be in the range of $32-$38 million and adjusted SG&A expenses between $50 million and $60 million, with share-based compensation expenses projected at $18-$20 million [12] Cash Position and Future Outlook - As of December 31, 2024, Theravance had cash, cash equivalents, and marketable securities amounting to $88.4 million, down from $91.4 million as of September 30, 2024 [11] - The company anticipates adjusted losses and cash burn in 2025 to be similar to 2024 levels, with an adjusted loss of $16 million and cash burn of $14 million recorded in 2024 [13] Pipeline Developments - Theravance is developing ampreloxetine (TD-9855), a norepinephrine reuptake inhibitor for treating neurogenic orthostatic hypotension in patients with multiple system atrophy [14] - The phase III CYPRESS study for ampreloxetine was initiated in 2024, with patient enrollment expected to complete by mid-2025, and top-line data anticipated six months post-enrollment [15]

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]

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]