Industry Overview - The uncertainty surrounding tariffs and trade measures has impacted economic growth, with President Trump threatening to impose tariffs as high as 200% on pharmaceutical imports to encourage domestic production [1] - Despite these threats, the biotech sector has remained stable, with many global pharmaceutical companies already investing in domestic manufacturing [1] Current Trends - The Zacks Medical-Drugs industry is showing promising trends due to positive pipeline and regulatory developments [2] - Key areas of innovation include rare diseases, next-generation oncology treatments, obesity, immunology, and neuroscience, attracting significant investor interest [3] M&A Activity - M&A activity in the sector remains healthy, indicating growth potential for companies like Catalyst Pharmaceuticals, Zevra Therapeutics, Theravance Biopharma, Aldeyra Therapeutics, and Larimar Therapeutics [3] Industry Characteristics - The Zacks Medical-Drugs industry consists of small to medium-sized drug companies that produce medicines for human and veterinary use, often relying on collaboration payments for revenue [4] Factors Influencing Future Growth - The success of key pipeline candidates in clinical studies can significantly impact stock prices, with successful innovations acting as catalysts [5] - Strong collaboration with larger drugmakers is a positive indicator for small pharma companies, especially when equity investments are involved [6] - Investment in technology and personalized medicine is crucial for smaller companies to thrive in a changing healthcare landscape [7] Performance Metrics - The Zacks Medical-Drugs industry currently holds a Zacks Industry Rank of 96, placing it in the top 39% of 245 Zacks industries, indicating strong prospects [9] - Year-to-date, the industry has risen 5.6%, outperforming the Zacks Medical sector, which has decreased by 2.9%, while slightly underperforming the S&P 500, which has risen by 6.9% [11] Valuation - The industry is currently trading at a trailing 12-month price-to-sales ratio of 2.32, compared to the S&P 500's 5.66 and the Zacks Medical sector's 2.37 [12] Company Highlights - **Catalyst Pharmaceuticals**: Lead drug Firdapse shows strong demand; stock has risen 0.4% this year; earnings estimate for 2025 increased from $2.23 to $2.25 [16][17] - **Theravance Biopharma**: Strong sales from Yupelri; stock has risen 22.6% this year; earnings estimate for 2025 declined from 3 cents to 1 cent [20][21] - **Larimar Therapeutics**: Developing nomlabofusp for Friedreich's ataxia; stock has declined 18.3% this year; loss estimate for 2025 narrowed from $1.90 to $1.89 [24][25] - **Zevra Therapeutics**: Early adoption of Miplyffa exceeds expectations; stock has risen 53.4% this year; earnings estimate for 2025 increased from 31 cents to 76 cents [28][29] - **Aldeyra Therapeutics**: Focused on RASP modulators; stock has declined 0.4% this year; loss estimate for 2025 narrowed from $1.03 to 90 cents [31][32]

Core Viewpoint - Theravance Biopharma announces that Viatris has received regulatory approval in China for YUPELRI® (revefenacin), marking it as the first once-daily nebulized long-acting muscarinic antagonist (LAMA) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in the country [1][7] Financial Impact - The approval triggers a one-time milestone payment of $7.5 million from Viatris to Theravance Biopharma, expected in Q3 2025 [2] - Theravance Biopharma is also eligible for additional sales-based milestones of up to $37.5 million and tiered royalties ranging from 14% to 20% on net sales in China [2] - The company reported a financial position that includes $131 million in cash as of March 31, 2025, and an additional $225 million from the recent sale of TRELEGY royalties to GSK [3] Product Development - Theravance Biopharma is nearing completion of enrollment in the open label portion of CYPRESS, a registrational study for ampreloxetine, which targets symptomatic neurogenic orthostatic hypotension associated with multiple system atrophy [3] - Ampreloxetine has shown potential benefits in increasing norepinephrine levels and improving blood pressure without worsening supine hypertension in MSA patients [4] Study Details - The CYPRESS study (Study 0197) is a Phase 3, multi-center, randomized withdrawal study evaluating the efficacy and durability of ampreloxetine after 20 weeks of treatment [5] - The primary endpoint of the study is the change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score [5] Company Overview - Theravance Biopharma focuses on delivering innovative medicines, with YUPELRI® approved for COPD maintenance treatment and ampreloxetine in late-stage development for symptomatic neurogenic orthostatic hypotension [6][8]

Core Insights - Theravance Biopharma (TBPH) has entered into an agreement to sell its remaining royalty interest in Trelegy Ellipta to GSK plc for $225 million in cash [1][2] - The transaction is part of Theravance's strategic review efforts to maximize shareholder value, with potential additional milestone payments of up to $150 million from Royalty Pharma based on Trelegy Ellipta's net sales in 2025 and 2026 [2][7] - Following the announcement, Theravance's shares increased by 22% [2] Financial Performance - Theravance's stock has increased by 18.5% year-to-date, contrasting with a 1.9% decline in the industry [3] - In February 2025, Theravance received a $50 million milestone payment based on Trelegy Ellipta's net sales of $3.46 billion in 2024, with a similar milestone payment of $150 million contingent on projected sales of approximately $3.41 billion in 2025 and $3.51 billion in 2026 [4][8] Revenue Generation - Theravance generates revenue from its collaboration with Viatris (VTRS) related to the sales of Yupelri, a nebulized therapy for COPD, sharing profits at a ratio of 35% for Theravance and 65% for Viatris [9][10] - In Q1 2025, Theravance reported $15.4 million in collaboration revenues from Yupelri sales, reflecting a year-over-year increase of 6.2% [11] Pipeline Development - Theravance is developing ampreloxetine, a norepinephrine reuptake inhibitor for treating symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA) [11] - The phase III CYPRESS study for ampreloxetine is expected to complete patient enrollment by late summer, with top-line data anticipated six months post-enrollment [12]

Financial Data and Key Metrics Changes - The total YUPELRI business has shown strong growth, particularly in the hospital channel, recovering well post-COVID pandemic [2][3] - The company has been able to slightly increase pricing, stabilizing it after previous disruptions [12] Business Line Data and Key Metrics Changes - The hospital business for YUPELRI has been growing unit volume at a faster rate, driven by formulary wins and increased sales representative collaboration with Viatris [4][5] - The company is still in the early stages of growth for YUPELRI, indicating significant potential for future expansion [9] Market Data and Key Metrics Changes - The entry of ensifentrine has not significantly impacted the market share of YUPELRI, as it is generally added to existing therapies rather than replacing them [10][11] - The company is focused on optimizing the channel to improve net pricing and overall fulfillment processes [12] Company Strategy and Development Direction - The company is prioritizing the growth of YUPELRI in the hospital setting before considering adding new products to the sales force [14][15] - Ampreloxetine is viewed as a critical asset for future growth, with a focus on efficient commercialization strategies [30][32] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the long-term potential of YUPELRI and Trelegy, highlighting the challenges of replicating Trelegy's success [33][35] - The company is committed to returning excess capital to shareholders while focusing on the success of YUPELRI and the development of ampreloxetine [38] Other Important Information - The company has a strong cash position with $130 million on the balance sheet and potential milestones from Trelegy and YUPELRI [31] - The development of Ampreloxetine is seen as a unique opportunity to address a significant unmet need in treating MSA patients [19][24] Q&A Session Summary Question: Are you losing patients at the initial script fill or during refills? - Management indicated that they lose patients both at the initial fill and during follow-up with regional pulmonologists [8] Question: How is the enrollment for the Ampreloxetine study progressing? - Management emphasized the importance of selecting the right patients and sites for the study, ensuring quality care throughout the process [26][27] Question: What is the long-term outlook for Trelegy and its royalties? - Management believes that Trelegy will continue to perform well in both asthma and COPD markets, with royalties reverting back to the company in 2029 [35]

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements (unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) Unaudited Q1 2025 financial statements detail a net loss and a significant increase in cash from a milestone payment Key Financial Highlights (Q1 2025 vs Q1 2024) | Metric | Q1 2025 ($ thousands) | Q1 2024 ($ thousands) | | :--- | :--- | :--- | | Total Revenues | 15,388 | 14,503 | | Loss from Operations | (14,434) | (11,207) | | Net Loss | (13,579) | (11,664) | | Net Loss per Share | (0.27) | (0.24) | | Cash from Operating Activities | 43,039 | (1,022) | - Total assets decreased slightly to **$343.6 million** as of March 31, 2025, from **$354.2 million** at year-end 2024, while cash and cash equivalents significantly increased to **$110.6 million** from **$37.8 million**, primarily due to a **$50.0 million** milestone payment from Royalty Pharma[8](index=8&type=chunk)[40](index=40&type=chunk) - The company confirms it has sufficient cash, cash equivalents, and marketable securities to fund its operations for at least the next twelve months from the filing date[18](index=18&type=chunk) [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The March 31, 2025 balance sheet highlights total assets of $343.6 million and a notable increase in cash and cash equivalents Balance Sheet Summary (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $110,614 | $37,797 | | Total current assets | $150,264 | $161,067 | | Total assets | $343,582 | $354,161 | | Total current liabilities | $31,502 | $32,085 | | Total shareholders' equity | $165,983 | $175,545 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Q1 2025 statements of operations report total revenues of $15.4 million and a net loss of $13.6 million Q1 2025 vs Q1 2024 Statement of Operations (in thousands) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Total Revenues | $15,388 | $14,503 | | Research and development | $11,452 | $8,968 | | Selling, general and administrative | $18,370 | $16,742 | | Loss from operations | $(14,434) | $(11,207) | | Net loss | $(13,579) | $(11,664) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Q1 2025 cash flow statements show net cash provided by operating activities of $43.0 million, significantly boosted by a $50.0 million milestone payment Cash Flow Summary (in thousands) | Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $43,039 | $(1,022) | | Net cash provided by investing activities | $30,632 | $17,028 | | Net cash used in financing activities | $(854) | $(1,716) | | Net increase in cash, cash equivalents, and restricted cash | $72,817 | $14,290 | - The positive operating cash flow was mainly due to the collection of a **$50.0 million** receivable related to milestones and royalty assets[13](index=13&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes to financial statements detail accounting policies, Viatris collaboration revenue, a $50.0 million milestone, and YUPELRI patent litigation - Revenue of **$15.4 million** is derived from the Viatris collaboration agreement for YUPELRI, under which the company receives **35%** of the profit/loss from US commercialization[29](index=29&type=chunk)[34](index=34&type=chunk)[35](index=35&type=chunk) - In February 2025, the company received a **$50.0 million** milestone payment from Royalty Pharma related to 2024 TRELEGY global net sales, with a remaining future contingent milestone and royalty asset of **$144.2 million**[51](index=51&type=chunk)[52](index=52&type=chunk) - The company is in patent infringement litigation against several generic companies regarding YUPELRI, with settlements granting five companies a license to launch a generic version on April 23, 2039, while litigation against three others remains pending[73](index=73&type=chunk)[75](index=75&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2025 financial condition and results, noting YUPELRI sales growth, increased R&D and SG&A expenses, and sufficient liquidity - The company's focus is on its commercial product **YUPELRI®** for COPD and its late-stage investigational drug, **ampreloxetine**, for symptomatic neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA)[80](index=80&type=chunk) - A **$50.0 million** milestone payment related to TRELEGY sales was received from Royalty Pharma in February 2025, with an additional **$150.0 million** in potential milestone payments remaining[99](index=99&type=chunk)[100](index=100&type=chunk) Key Expense Changes (Q1 2025 vs Q1 2024) | Expense Category | Q1 2025 ($ thousands) | Q1 2024 ($ thousands) | % Change | Primary Driver | | :--- | :--- | :--- | :--- | :--- | | Research & Development | $11,452 | $8,968 | 28% | Ampreloxetine Phase 3 study costs | | Selling, General & Administrative | $18,370 | $16,742 | 10% | Ampreloxetine pre-launch activities | - As of March 31, 2025, the company had approximately **$130.9 million** in cash, cash equivalents, and marketable securities, with no long-term debt, and expects this to be sufficient to fund operations for at least the next twelve months[123](index=123&type=chunk)[125](index=125&type=chunk) [Management Overview](index=28&type=section&id=Management%20Overview) This overview details the company's core programs, YUPELRI and ampreloxetine, including collaboration terms and economic interests in TRELEGY - **YUPELRI** (revefenacin) is co-promoted with Viatris in the US under a **35%** (Theravance) / **65%** (Viatris) profit and loss sharing arrangement[84](index=84&type=chunk) - **Ampreloxetine** is in a Phase 3 study (CYPRESS) for MSA patients with symptomatic nOH, with top-line data anticipated approximately six months after final patient enrollment by late summer 2025[96](index=96&type=chunk) - The company retains a mid- and long-term economic interest in **TRELEGY**, including up to **$150.0 million** in remaining potential milestone payments from Royalty Pharma and **85%** of royalties in outer years (post-2029/2031)[98](index=98&type=chunk)[100](index=100&type=chunk)[104](index=104&type=chunk) [Results of Operations](index=37&type=section&id=Results%20of%20Operations) This section details Q1 2025 financial performance, noting a 6% revenue increase, a 28% rise in R&D expenses, and a 10% increase in SG&A expenses YUPELRI Net Sales (in thousands) | Metric | Q1 2025 | Q1 2024 | % Change | | :--- | :--- | :--- | :--- | | YUPELRI net sales (100% recorded by Viatris) | $58,344 | $55,226 | 6% | | YUPELRI net sales (Theravance Biopharma implied 35%) | $20,420 | $19,329 | 6% | - The increase in YUPELRI sales was driven by a **5%** rise in customer demand and a **48%** increase in doses through the hospital channel compared to the prior year[112](index=112&type=chunk) - R&D expenses increased by **$2.5 million** (**28%**) YoY, mainly due to a **$2.2 million** increase in external costs for the ampreloxetine CYPRESS study and related NDA activities[115](index=115&type=chunk) - SG&A expenses increased by **$1.6 million** (**10%**) YoY, primarily due to a **$1.2 million** increase in pre-launch medical/commercial expenses for ampreloxetine and a **$0.3 million** increase in G&A costs for the ongoing strategic review[117](index=117&type=chunk)[118](index=118&type=chunk) [Liquidity and Capital Resources](index=41&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company held $130.9 million in cash and marketable securities, with sufficient liquidity for the next twelve months - The company had **$130.9 million** in cash, cash equivalents, and marketable securities as of March 31, 2025, and no long-term debt[123](index=123&type=chunk) - Management believes existing cash resources are sufficient to fund operations for at least the next twelve months[125](index=125&type=chunk) Cash Flow Summary (in thousands) | Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $43,039 | $(1,022) | | Net cash provided by investing activities | $30,632 | $17,028 | | Net cash used in financing activities | $(854) | $(1,716) | [Quantitative and Qualitative Disclosures About Market Risk](index=43&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a "smaller reporting company," the company is not required to provide quantitative and qualitative disclosures about market risk - As a "smaller reporting company," the company is not required to provide quantitative and qualitative disclosures about market risk[134](index=134&type=chunk) [Controls and Procedures](index=43&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal controls - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of March 31, 2025[135](index=135&type=chunk) - No changes in internal control over financial reporting occurred during Q1 2025 that materially affected, or are reasonably likely to materially affect, internal controls[138](index=138&type=chunk) [PART II. OTHER INFORMATION](index=45&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=45&type=section&id=Item%201.%20Legal%20Proceedings) This section details ongoing patent infringement litigation concerning YUPELRI, including FDA stays and settlements with some generic companies for a 2039 launch - The company is engaged in patent infringement lawsuits against multiple generic companies that filed ANDAs for a generic version of YUPELRI[139](index=139&type=chunk) - The lawsuits have triggered an FDA stay, preventing approval of the generic ANDAs through May 2026, pending court decisions[139](index=139&type=chunk) - Settlements have been reached with five generic companies (Accord, Lupin, Orbicular, Qilu, and Teva), allowing for a licensed generic launch on April 23, 2039, while litigation against three other generic companies remains pending[141](index=141&type=chunk) [Risk Factors](index=47&type=section&id=Item%201A.%20Risk%20Factors) This section outlines principal risks, including net losses, reliance on YUPELRI, ampreloxetine development uncertainties, generic competition, and strategic review outcomes - The company has a history of net losses, including **$13.6 million** in Q1 2025, and may never achieve or sustain profitability from operations[147](index=147&type=chunk) - The company's business is highly dependent on the continued commercial success of **YUPELRI**, which faces competition and pricing pressures, and on its collaboration with Viatris[153](index=153&type=chunk)[162](index=162&type=chunk) - There are significant risks associated with the development of **ampreloxetine**, including the potential for the Phase 3 CYPRESS study to be delayed, fail to meet its endpoints, or not receive regulatory approval[155](index=155&type=chunk)[158](index=158&type=chunk) - The company faces patent litigation from generic companies seeking to market a version of **YUPELRI**, which could result in earlier-than-expected generic competition[187](index=187&type=chunk)[241](index=241&type=chunk) - The ongoing strategic review process, announced in November 2024, may be distracting, costly, and may not result in a transaction, which could adversely affect the business and shareholder value[169](index=169&type=chunk)[170](index=170&type=chunk)[171](index=171&type=chunk) [Exhibits](index=110&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the 10-Q report, including CEO and CFO certifications and financial statements in iXBRL format - The exhibits include certifications from the Chief Executive Officer and Chief Financial Officer as required by SEC rules (Exhibits 31.1, 31.2, and 32)[316](index=316&type=chunk) - The financial statements and notes are provided in iXBRL format (Exhibit 101), and the cover page interactive data file is also included (Exhibit 104)[316](index=316&type=chunk)

Core Viewpoint - Theravance Biopharma reported a wider-than-expected adjusted net loss for Q1 2025, indicating ongoing financial challenges despite a year-over-year revenue increase driven by collaboration revenues from Viatris [1][2]. Financial Performance - The adjusted net loss for Q1 2025 was 17 cents per share, compared to a loss of 11 cents estimated by Zacks Consensus, and a loss of 9 cents in the same quarter last year [1]. - Total revenues for the first quarter were $15.4 million, missing the Zacks Consensus Estimate of $16 million, but representing a 6.2% increase year-over-year due to higher collaboration revenues from Viatris [2]. - The reported loss, including share-based compensation and other expenses, was 27 cents per share, compared to a loss of 24 cents in the prior year [2]. Collaboration and Revenue Sources - Revenues were entirely derived from Viatris' collaboration related to Yupelri (revefenacin) sales, which is used for chronic obstructive pulmonary disease treatment [4]. - Viatris recorded $58.3 million in U.S. net sales of Yupelri for Q1 2025, reflecting a 6% year-over-year increase [6]. - Theravance receives 35% of the profits from Yupelri sales, while Viatris retains 65% [5]. Expenses and Financial Guidance - Research and development expenses (excluding share-based compensation) were $10.4 million, up 40.5% from the previous year, while selling, general, and administrative expenses increased by 13.2% to $14.6 million [10]. - Theravance reaffirmed its financial guidance for 2025, expecting adjusted R&D expenses between $32 million and $38 million, and SG&A expenses between $50 million and $60 million [11]. Pipeline Developments - Theravance is developing ampreloxetine, a norepinephrine reuptake inhibitor for treating symptomatic neurogenic orthostatic hypotension in patients with multiple system atrophy [12]. - The phase III CYPRESS study for ampreloxetine is expected to complete patient enrollment by late summer, with top-line data anticipated six months post-enrollment [13].

Core Insights - Theravance Biopharma presented analyses of its Phase 3 program for ampreloxetine, targeting symptomatic neurogenic orthostatic hypotension (nOH) at the International MSA Congress in Boston [1][2] Company Overview - Theravance Biopharma focuses on developing innovative therapies, including ampreloxetine, a selective norepinephrine reuptake inhibitor for treating nOH in patients with multiple system atrophy (MSA) [6][13] - 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 [6] Clinical Study Findings - A subgroup analysis from the REDWOOD 0170 study indicated that MSA patients had the highest nOH symptom burden, emphasizing the need for improved therapies [2] - Results from the studies support the ongoing registrational study (CYPRESS) evaluating ampreloxetine's efficacy in MSA patients [3] - Patients with MSA showed clinically meaningful improvement in nOH symptoms after 16 weeks of treatment with ampreloxetine, with stable symptoms in the treatment group compared to worsening in the placebo group [7][10] Study Details - The CYPRESS study is a Phase 3, multi-center, randomized withdrawal trial assessing ampreloxetine's efficacy after 20 weeks of treatment, with primary endpoints focused on changes in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score [9] - The REDWOOD 0170 study included a 16-week open-label period followed by a 6-week double-blind, placebo-controlled withdrawal period, with a primary endpoint of treatment failure defined by specific worsening scores [10] Patient Impact - MSA patients experience severe symptoms affecting their quality of life due to nOH, with 70-90% of MSA patients experiencing these symptoms [11] - The clinical profile of ampreloxetine demonstrated target engagement and sustained blood pressure effects, indicating its potential as a first-in-class therapy for MSA-related nOH [6][7]

YUPELRI Performance and Potential - YUPELRI net sales for Q1 2025 reached $58.3 million, a 6% increase compared to Q1 2024[10, 24] - Hospital doses of YUPELRI increased by 48% in Q1 2025 compared to Q1 2024[10, 20] - Theravance Biopharma receives 35% of US profits from YUPELRI sales due to a co-promotion agreement with Viatris[9, 11, 16, 23, 58] - A $25 million milestone is achievable if US net sales of YUPELRI exceed $250 million, requiring a 5% growth from 2024[24, 57] - Viatris submitted an NDA in China for YUPELRI in June 2024, with a potential $45 million milestone and 14-20% tiered royalties for Theravance Biopharma[24, 57] TRELEGY Milestones and Royalties - 2024 TRELEGY net sales reached $854 million, a 14% year-over-year increase, positioning the company to trigger a $50 million milestone in 2025[10, 27] - Theravance Biopharma could receive up to $150 million in TRELEGY sales milestones in 2025 and 2026[9, 27, 57] - To trigger the first $25 million milestone in 2025, Royalty Pharma needs to receive $260 million or more in royalty payments from GSK, equivalent to $3063 billion in TRELEGY global net sales[9] - Royalties from TRELEGY net sales, ranging from 5.5% to 8.5%, will return to Theravance Biopharma starting July 1, 2029 (ex-US) and January 1, 2031 (US), extending through the mid-2030s[32, 34, 57, 58] Financial Overview - Theravance Biopharma's cash and cash equivalents totaled $130.9 million at the end of Q1 2025, including a $50 million TRELEGY milestone payment received in February 2025, with no debt[10, 50, 57] - Non-GAAP net loss for Q1 2025 was $8.6 million, compared to $4.5 million for Q1 2024[45, 50] - VIATRIS collaboration revenue was $15.4 million in Q1 2025, compared to $14.5 million in Q1 2024[45, 50]

Company Performance - Theravance Biopharma reported a quarterly loss of $0.17 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.11, and compared to a loss of $0.09 per share a year ago, indicating a significant earnings surprise of -54.55% [1] - The company posted revenues of $15.39 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 4.20%, but showing an increase from year-ago revenues of $14.5 million [2] - Over the last four quarters, the company has surpassed consensus EPS estimates just once and topped consensus revenue estimates two times [2] Stock Outlook - Theravance Bio shares have increased by approximately 6.2% since the beginning of the year, contrasting with the S&P 500's decline of -4.3% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.12 on revenues of $17.1 million, and for the current fiscal year, it is $0.08 on revenues of $96.9 million [7] - The estimate revisions trend for Theravance Bio is mixed, resulting in a Zacks Rank 3 (Hold), suggesting that the shares are expected to perform in line with the market in the near future [6] Industry Context - The Medical - Drugs industry, to which Theravance Bio belongs, is currently ranked in the top 26% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Financial Data and Key Metrics Changes - YUPELRI net sales increased by 6% to just over $58 million, driven by increased demand and favorable pricing [2][4] - Collaboration revenue reported at $15.4 million, up 6% year over year, with YUPELRI brand level cash profitability growing faster than collaboration revenue [16][18] - The company ended the quarter with $131 million in cash and no debt, reflecting a strong financial position [18][24] Business Line Data and Key Metrics Changes - Hospital doses of YUPELRI increased by 48% year on year, achieving record high volume with approximately 316,000 units pulled through the hospital channel [2][7] - GSK reported Trelegy global net sales up 14%, positioning the company to achieve a $50 million milestone from Royalty Pharma in 2025 [4][10] Market Data and Key Metrics Changes - Market research indicates significant future potential for YUPELRI, with additional demand growth expected and a sizable remaining addressable patient population [8] - The company anticipates a decline in clinical trial costs in the second half of the year as the Cyprus study nears completion [19] Company Strategy and Development Direction - The company remains focused on advancing the Sypris trial and optimizing patient enrollment and experience [3] - YUPELRI is positioned as a core growth driver, with strategies in place to improve its financial contribution and achieve key economic milestones [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the commercial prospects of ampreloxetine, with ongoing engagement with payers to ensure understanding of the therapy's role [35][38] - The company reaffirmed its financial guidance metrics and does not anticipate material impacts from potential tariff measures [19][21] Other Important Information - The company is on track to achieve a one-time $25 million milestone if YUPELRI sales reach $250 million in the calendar year [24] - The company is preparing for an expedited NDA submission for ampreloxetine, with significant progress on key modules already completed [16][25] Q&A Session Questions and Answers Question: Status update on ampreloxetine manufacturing and IP - The IP for ampreloxetine is currently in Ireland, with manufacturing of the API outside the U.S. in Taiwan, allowing flexibility in supply adjustments [28] Question: Efforts to increase hospital prescriptions turning into filled chronic prescriptions - The company is focused on ensuring patients receive support through fulfillment programs and follow-up care, emphasizing the importance of local partnerships [29][31] Question: Feedback from payers on ampreloxetine - The company has started engaging with payers to educate them on the disease burden and the role of ampreloxetine, with further discussions expected post-top line data [35][36] Question: Update on YUPELRI Paragraph IV filers - The company has settled with five of the eight filers, with three outstanding litigants remaining [39]