分组1 - Theravance Biopharma reported a quarterly loss of $0.08 per share, better than the Zacks Consensus Estimate of a loss of $0.14, representing an earnings surprise of +42.86% [1] - The company posted revenues of $26.2 million for the quarter ended June 2025, exceeding the Zacks Consensus Estimate by 53.76%, compared to $14.26 million in the same quarter last year [2] - Theravance Bio shares have increased by approximately 21.2% since the beginning of the year, outperforming the S&P 500's gain of 8.4% [3] 分组2 - The current consensus EPS estimate for the upcoming quarter is -$0.09 on revenues of $18.12 million, and for the current fiscal year, it is $0.01 on revenues of $96.03 million [7] - The Medical - Drugs industry, to which Theravance Bio belongs, is currently ranked in the top 35% of over 250 Zacks industries, indicating a favorable outlook [8]

Financial Data and Key Metrics Changes - The company reported net sales for YUPELRI of approximately $66 million for the quarter, representing a 22% year-over-year increase, marking the highest Q2 results since launch [4][8] - Collaboration revenue grew by 31% year-over-year, driven by YUPELRI's net sales growth, leading to improved brand-level profit margins [22][24] - Non-GAAP losses improved to $4.2 million compared to $6.3 million in the prior year, excluding one-time items [25] Business Line Data and Key Metrics Changes - YUPELRI's hospital channel volume increased by 31% compared to 2024, with a long-acting nebulized market share in hospitals reaching approximately 20% [10][11] - The company completed the $225 million sale of its remaining royalty interest in Trelegy to GSK, significantly strengthening its balance sheet [4][22] - Ampreloxetine's Phase 3 Cyprus trial is nearing completion of enrollment, with expectations to report top-line data approximately six months after [5][28] Market Data and Key Metrics Changes - YUPELRI received approval in China, triggering a $7.5 million milestone payment, with plans for commercialization led by Beatrice [4][11] - GSK reported an all-time high of $1.1 billion in Trelegy sales for Q2, contributing to a year-to-date sales total of approximately $2 billion, an 8% increase year-over-year [22] Company Strategy and Development Direction - The company is focused on enhancing shareholder value through strategic reviews and disciplined capital management [6][28] - Ampreloxetine is positioned as a potential transformative therapy for patients with multiple system atrophy (MSA), with a targeted addressable population of approximately 40,000 patients in the U.S. [21][28] - The company aims to maintain a strong financial position while preparing for the upcoming data readout from the Cyprus study [28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the $250 million sales threshold for YUPELRI, which would trigger a $25 million milestone payment [9][10] - The company anticipates a stronger second half of the year compared to previous expectations, creating a solid financial foundation as it approaches the Cyprus data readout [26][28] - Management highlighted the importance of the upcoming Cyprus trial results, which could redefine the standard of care for patients with MSA [28] Other Important Information - The company ended the quarter with approximately $340 million in cash and no debt, indicating strong cash management [6][25] - The company is preparing for NDA readiness in parallel with the Cyprus study, with modules already in advanced stages of drafting [19] Q&A Session Summary Question: What contributed to the improved pull-through for YUPELRI this quarter? - Management attributed the improved pull-through to the shift of volume to specialty pharmacy, which enhances patient support and fulfillment [32][35] Question: What is the outlook for YUPELRI in China and the enrollment trends for Cyprus? - Management noted that Beatrice will lead the commercialization in China, and the enrollment profile for Cyprus is expected to be similar to previous studies [41][42] Question: How will pricing for Ampreloxetine be determined? - Management indicated that while it is early to finalize pricing, analysis of recent rare neuro drug launches suggests an average price around $380,000 per year [47] Question: What are the expectations for SG&A increases associated with Ampreloxetine? - Management expects SG&A to remain stable through the second half of the year, with potential increases post-data readout if results are positive [54][56]

YUPELRI Performance and Growth - YUPELRI net sales reached $663 million in Q2 2025, a 22% increase compared to Q2 2024[8, 19] - Excluding a one-time favorable price adjustment, YUPELRI sales still experienced mid-teens growth[19] - Hospital doses of YUPELRI grew by 31% compared to Q2 2024, achieving a new market share high of 204%[8, 19] - The YUPELRI approval in China triggered a $75 million milestone payment and potential tiered royalties of 14-20%[8, 19] Ampreloxetine Development - Enrollment in the pivotal Phase 3 CYPRESS study for Ampreloxetine is expected to be completed in late summer, with topline data anticipated approximately 6 months later[8] - Ampreloxetine targets approximately 40000 underserved patients with symptomatic nOH due to MSA[61] TRELEGY Milestones and Financials - Q2 2025 net sales of TRELEGY were approximately $11 billion, and year-to-date net sales reached approximately $20 billion, up 8% year-over-year[8, 40] - The company completed the sale of TRELEGY royalty interest for $225 million[8] - Theravance Biopharma is on pace to achieve $150 million in TRELEGY sales milestones in 2025 and 2026[40] Financial Highlights - Viatris collaboration revenue was $187 million in Q2 2025, a 31% increase year-over-year[47, 52] - Licensing revenue was $75 million in Q2 2025, driven by the YUPELRI China approval milestone[47, 52] - The company's cash and cash equivalents totaled $3388 million as of the end of Q2 2025, including the $225 million cash receipt from the TRELEGY royalty sale[52] - Non-GAAP net loss for Q2 2025 was $42 million[47, 52]

[Executive Summary and Corporate Update](index=1&type=section&id=Executive%20Summary%20and%20Corporate%20Update) Theravance Biopharma reported strong Q2 2025 performance, driven by commercial growth, strategic asset monetization, and clinical development progress [Q2 2025 Performance Overview](index=1&type=section&id=Q2%202025%20Performance%20Overview) Theravance Biopharma reported strong Q2 2025 performance, fueled by YUPELRI's commercial growth, a China approval milestone, and strategic TRELEGY royalty monetization, with ampreloxetine Phase 3 enrollment progressing - Strong execution across the business, driven by commercial growth, disciplined operations, and continued progress on ampreloxetine[3](index=3&type=chunk) - YUPELRI posted another strong quarter in the U.S., and its recent approval in China triggered a **$7.5 million** milestone payment[3](index=3&type=chunk) - Completion of the strategic monetization of TRELEGY royalty interest brought in **$225 million**, meaningfully strengthening the business[3](index=3&type=chunk) - Enrollment in the pivotal Phase 3 CYPRESS study for ampreloxetine is on track for completion by late summer, with top-line data anticipated approximately six months later[3](index=3&type=chunk) [Second Quarter Operational Highlights](index=1&type=section&id=Second%20Quarter%20Operational%20Highlights) Q2 operational highlights include strong YUPELRI sales, ampreloxetine Phase 3 progress, and the strategic TRELEGY royalty sale [YUPELRI (revefenacin) Performance](index=1&type=section&id=YUPELRI%20%28revefenacin%29%20Performance) YUPELRI achieved **$66.3 million** in U.S. net sales in Q2 2025, a **22%** year-over-year increase, supported by customer demand growth and a **$7.5 million** China approval milestone YUPELRI Performance Metrics | Metric | Q2 2025 Value | Year-over-Year Change | | :-------------------------------- | :------------ | :-------------------- | | YUPELRI U.S. Net Sales (Viatris) | $66.3 million | +22% | | Customer Demand Growth | 4% | | | Hospital Channel Doses Growth | | +31% | | China Approval Milestone Payment | $7.5 million | N/A | - Net sales benefited from continued improvement to net pricing and a one-time favorable adjustment; excluding this, year-over-year net sales growth would have been in the mid-teens[6](index=6&type=chunk) [Ampreloxetine Development Update](index=1&type=section&id=Ampreloxetine%20Development%20Update) The pivotal Phase 3 CYPRESS study for ampreloxetine is on track for enrollment completion by late summer, with pre-launch activities advancing for potential approval - Pivotal Phase 3 CYPRESS study enrollment nearing completion with final patient expected to be enrolled by late summer; top-line data anticipated approximately six months later[9](index=9&type=chunk) - Advancing pre-launch activities across medical affairs and commercial functions in preparation for the potential approval of ampreloxetine[9](index=9&type=chunk) [TRELEGY Royalty Interest Sale](index=1&type=section&id=TRELEGY%20Royalty%20Interest%20Sale) Theravance Biopharma completed the sale of its TRELEGY ELLIPTA royalty interest to GSK for a **$225 million** cash payment, resulting in a **$75.1 million** net gain - Completed sale of TRELEGY ELLIPTA royalty interest to GSK for **$225 million**[5](index=5&type=chunk) - One-time cash payment of **$225 million** received in late Q2 2025[9](index=9&type=chunk) - Net gain on realized contingent milestone and royalty assets was **$75.1 million**, based on sales proceeds of **$225.0 million** less carrying value and transaction costs[11](index=11&type=chunk) - This transaction is the first outcome of the Strategic Review Committee's ongoing efforts to assess strategic alternatives and enhance shareholder value[9](index=9&type=chunk) [Second Quarter Financial Results](index=2&type=section&id=Second%20Quarter%20Financial%20Results) Q2 financial results highlight revenue growth, controlled expenses, a net income turnaround, and a strengthened cash position [Revenue Breakdown](index=2&type=section&id=Revenue%20Breakdown) Total revenue for Q2 2025 surged to **$26.2 million**, an **83.7%** increase year-over-year, driven by Viatris collaboration revenue and a **$7.5 million** licensing payment Revenue by Type | Revenue Type | Q2 2025 (in thousands) | Q2 2024 (in thousands) | Change YoY | | :-------------------------- | :--------------------- | :--------------------- | :--------- | | Viatris collaboration agreement | $18,695 | $14,256 | +31% | | Licensing revenue | $7,500 | $0 | N/A | | **Total Revenue** | **$26,195** | **$14,256** | **+83.7%** | - Viatris collaboration revenue represents the Company's **35% share of net sales of YUPELRI**, as well as its proportionate amount of total shared commercial costs[8](index=8&type=chunk) - Theravance Biopharma's implied **35% share of net sales of YUPELRI** for Q2 2025 was **$23.2 million**, a **22% increase** compared to the same period in 2024[8](index=8&type=chunk) [Operating Expenses](index=3&type=section&id=Operating%20Expenses) Q2 2025 R&D and SG&A expenses saw slight increases to **$10.5 million** and **$18.4 million** respectively, while share-based compensation decreased to **$4.5 million** Operating Expenses by Type | Expense Type | Q2 2025 (in thousands) | Q2 2024 (in thousands) | Change YoY | | :-------------------------- | :--------------------- | :--------------------- | :--------- | | Research and Development | $10,490 | $9,954 | +5.4% | | Selling, General and Administrative | $18,430 | $17,056 | +8.1% | | Share-Based Compensation | $4,543 | $5,376 | -15.4% | [Net Income (Loss) and Non-GAAP Net Loss](index=3&type=section&id=Net%20Income%20%28Loss%29%20and%20Non-GAAP%20Net%20Loss) The company achieved a net income of **$54.8 million** in Q2 2025, a significant turnaround from a prior-year loss, primarily due to a **$75.1 million** gain from the TRELEGY royalty sale Net Income (Loss) and Non-GAAP Net Loss | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | | :-------------------------- | :--------------------- | :--------------------- | | Net Income (Loss) | $54,835 | $(16,529) | | Non-GAAP Net Loss from Operations | $(4,225) | $(6,250) | - The increase in net income was driven by the **$75.1 million net gain** on contingent milestone and royalty assets arising from the sale of the remaining interest in TRELEGY royalties[11](index=11&type=chunk) - Income tax expense for Q2 2025 was **$18.4 million**, compared to **$1.3 million** in Q2 2024, primarily due to the net gain on royalty assets[11](index=11&type=chunk) [Cash Position](index=3&type=section&id=Cash%20Position) Theravance Biopharma's cash, cash equivalents, and marketable securities significantly increased to **$338.8 million** by June 30, 2025, largely due to the TRELEGY royalty sale proceeds Cash, Cash Equivalents and Marketable Securities | Metric | June 30, 2025 (in thousands) | Dec 31, 2024 (in thousands) | | :------------------------------------------ | :--------------------------- | :-------------------------- | | Cash, cash equivalents and short-term marketable securities | $338,804 | $88,350 | - Strong balance sheet with **$339 million in cash** and no debt[5](index=5&type=chunk) [2025 Financial Guidance](index=4&type=section&id=2025%20Financial%20Guidance) Theravance Biopharma maintains its full-year 2025 expense guidance, with non-GAAP net income and cash burn projected similar to 2024 [Full Year 2025 Outlook](index=4&type=section&id=Full%20Year%202025%20Outlook) The company reaffirms its 2025 guidance for R&D expenses between **$32-38 million** and SG&A between **$50-60 million**, with share-based compensation at **$18-20 million** Full Year 2025 Guidance | Metric | Full Year 2025 Guidance (in millions) | | :------------------------------------------ | :---------------------- | | R&D Expenses (excluding share-based comp.) | $32 to $38 | | SG&A Expenses (excluding share-based comp.) | $50 to $60 | | Share-Based Compensation Expenses | $18 to $20 | - Non-GAAP Net Income (Loss) from Operations and Cash Burn in 2025 are expected to be similar to levels incurred in 2024, excluding one-time, non-recurring revenue and income items[16](index=16&type=chunk) [Product and Clinical Program Details](index=4&type=section&id=Product%20and%20Clinical%20Program%20Details) This section details ampreloxetine as an investigational nOH therapy for MSA, outlining its Phase 3 study and the underlying disease [About Ampreloxetine](index=4&type=section&id=About%20Ampreloxetine) Ampreloxetine is an investigational, once-daily selective norepinephrine reuptake inhibitor for symptomatic nOH in MSA, with Orphan Drug Designation and potential for NDA filing - Ampreloxetine is an investigational, once-daily, selective norepinephrine reuptake inhibitor in development for symptomatic nOH in patients with MSA[15](index=15&type=chunk) - Unique benefits reported include increased norepinephrine levels, favorable blood pressure impact, clinically meaningful and durable symptom improvement, and no signal for worsening of supine hypertension[15](index=15&type=chunk) - Granted **Orphan Drug Designation** in the US for symptomatic nOH in MSA; plans to file an NDA for full approval if Phase 3 CYPRESS study results are supportive[15](index=15&type=chunk) [About CYPRESS (Study 0197), a Phase 3 Study](index=5&type=section&id=About%20CYPRESS%20%28Study%200197%29%2C%20a%20Phase%203%20Study) Study 0197 (CYPRESS) is a registrational Phase 3 randomized withdrawal study evaluating ampreloxetine's efficacy and durability in MSA patients with symptomatic nOH - Study 0197 (CYPRESS) is a registrational Phase 3, multi-center, randomized withdrawal study currently enrolling[17](index=17&type=chunk) - Evaluates the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after **20 weeks of treatment**[17](index=17&type=chunk) - The primary endpoint of the study is change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score[17](index=17&type=chunk) [About Multiple System Atrophy (MSA) and Symptomatic Neurogenic Orthostatic Hypotension (nOH)](index=5&type=section&id=About%20Multiple%20System%20Atrophy%20%28MSA%29%20and%20Symptomatic%20Neurogenic%20Orthostatic%20Hypotension%20%28nOH%29) MSA is a progressive brain disorder, frequently associated with nOH, a debilitating condition affecting **70-90%** of the approximately **50,000** US MSA patients - MSA is a progressive brain disorder affecting movement, balance, and autonomic nervous system function[18](index=18&type=chunk) - Neurogenic orthostatic hypotension (nOH), a sudden drop in blood pressure upon standing, affects **70-90%** of the approximately **50,000 MSA patients** in the US[18](index=18&type=chunk) - nOH is a debilitating condition resulting in symptoms such as dizziness, lightheadedness, fainting, fatigue, blurry vision, weakness, trouble concentrating, and head and neck pain[19](index=19&type=chunk) [About Theravance Biopharma](index=5&type=section&id=About%20Theravance%20Biopharma) Theravance Biopharma focuses on impactful medicines, leveraging expertise for FDA-approved YUPELRI and advancing ampreloxetine - Theravance Biopharma, Inc.'s focus is to deliver Medicines that Make a Difference in people's lives[20](index=20&type=chunk) - Leverages decades of expertise, leading to the development of FDA-approved **YUPELRI (revefenacin)** for COPD[20](index=20&type=chunk) - Ampreloxetine, its late-stage investigational therapy for symptomatic nOH in MSA, has the potential to be a first-in-class therapy[20](index=20&type=chunk) [Non-GAAP Financial Measures](index=3&type=section&id=Non-GAAP%20Financial%20Measures) Non-GAAP financial measures adjust GAAP net income for non-cash and non-recurring items, offering insights into core operating results and cash - Non-GAAP profit (loss) consists of GAAP net income (loss) before taxes less share-based compensation, non-cash interest expense, non-cash impairment expense, and non-recurring revenue and income items[10](index=10&type=chunk) - Non-GAAP profitability targets and metrics provide meaningful information to assist investors by excluding items not indicative of core operating results and the Company's cash position[26](index=26&type=chunk) - Non-GAAP measures should be considered in addition to, not as a substitute for, or in isolation from, the Company's actual GAAP results[26](index=26&type=chunk) - A reconciliation of non-GAAP net loss to its corresponding GAAP measure is not available on a forward-looking basis without unreasonable effort due to the uncertainty and potential variability of future expenses[27](index=27&type=chunk) [Financial Statements](index=8&type=section&id=Financial%20Statements) This section presents condensed consolidated balance sheets, statements of operations, and GAAP to non-GAAP net loss reconciliation [Condensed Consolidated Balance Sheets](index=8&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets increased to **$426.0 million** by June 30, 2025, driven by a significant rise in cash and equivalents, while liabilities and shareholders' equity also grew Condensed Consolidated Balance Sheets | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :------------------------------------------ | :--------------------------- | :------------------------------- | | Cash and cash equivalents and short-term marketable securities | $338,804 | $88,350 | | Receivables from milestone and royalty assets | $0 | $50,000 | | Future contingent milestone and royalty assets | $0 | $144,200 | | Total assets | $426,035 | $354,161 | | Total current liabilities | $54,633 | $32,085 | | Shareholders' equity | $224,848 | $175,545 | - The significant increase in cash and total assets is largely due to the **$225 million proceeds** from the TRELEGY royalty sale, which also eliminated the 'Future contingent milestone and royalty assets' line item[30](index=30&type=chunk) [Condensed Consolidated Statements of Operations](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q2 2025 saw total revenue of **$26.2 million** and a net income of **$54.8 million**, a substantial improvement from Q2 2024's net loss, primarily due to the TRELEGY royalty asset gain Condensed Consolidated Statements of Operations | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | | :------------------------------------------ | :---------------------------------------------- | :---------------------------------------------- | | Total Revenue | $26,195 | $14,256 | | Total Costs and Expenses | $28,920 | $29,961 | | Loss from operations | $(2,725) | $(15,705) | | Net gain on realized contingent milestone and royalty assets | $75,137 | $0 | | Net income (loss) | $54,835 | $(16,529) | | Net income (loss) per share - basic | $1.09 | $(0.34) | | Net income (loss) per share - diluted | $1.08 | $(0.34) | | Non-GAAP net loss | $(4,225) | $(6,250) | - The significant net income in Q2 2025 was primarily driven by the **$75.1 million net gain** from the sale of TRELEGY royalty assets[33](index=33&type=chunk) [Reconciliation of GAAP Net Income (Loss) to Non-GAAP Net Loss](index=11&type=section&id=Reconciliation%20of%20GAAP%20Net%20Income%20%28Loss%29%20to%20Non-GAAP%20Net%20Loss) GAAP net income of **$54.8 million** for Q2 2025 was adjusted to a non-GAAP net loss of **$4.2 million**, primarily by excluding non-recurring revenue and the TRELEGY royalty asset gain Reconciliation of GAAP Net Income (Loss) to Non-GAAP Net Loss | Adjustment Item | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | | :------------------------------------------ | :---------------------------------------------- | :---------------------------------------------- | | GAAP net income (loss) | $54,835 | $(16,529) | | Licensing revenue (non-recurring) | $(7,500) | $0 | | Net gain on realized contingent milestone and royalty assets (non-recurring) | $(75,137) | $0 | | Non-cash impairment expense of long-lived assets | $0 | $2,951 | | Share-based compensation expense | $4,543 | $5,376 | | Non-cash interest expense | $663 | $644 | | Income tax expense | $18,371 | $1,308 | | **Non-GAAP net loss** | **$(4,225)** | **$(6,250)** | [Additional Information](index=4&type=section&id=Additional%20Information) This section provides details on the conference call, forward-looking statements, and investor relations contact information [Conference Call and Live Webcast](index=4&type=section&id=Conference%20Call%20and%20Live%20Webcast) Theravance Biopharma held a conference call and webcast on **August 12, 2025**, to discuss Q2 results, with a replay available on the company's website until **September 11, 2025** - Conference call and live webcast held on **August 12, 2025**, at **5:00 pm ET / 2:00 pm PT / 9:00 pm GMT**[13](index=13&type=chunk) - A replay of the webcast will be available on Theravance Biopharma's website for **30 days** through **September 11, 2025**[14](index=14&type=chunk) [Forward-Looking Statements](index=6&type=section&id=Forward-Looking%20Statements) This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from projections - The press release contains "forward-looking" statements regarding goals, plans, objectives, expectations, and future events, covered by safe harbor provisions[24](index=24&type=chunk) - Statements are subject to risks, uncertainties, changes in circumstances, assumptions, and other factors that may cause actual results to be materially different[24](index=24&type=chunk) - Important factors include risks related to cash requirements, milestone achievement, delays in clinical studies, regulatory decisions, dependence on third parties, and intellectual property protection[24](index=24&type=chunk) [Contact Information](index=7&type=section&id=Contact%20Information) Investor Relations contact details are provided for further inquiries - Investor Relations Contact: **investor.relations@theravance.com**, **650-808-4045**[28](index=28&type=chunk)

Core Insights - Theravance Biopharma reported strong execution in Q2 2025, driven by commercial growth and operational discipline, with significant progress on ampreloxetine and a milestone payment from YUPELRI's approval in China [2][5][10] Financial Performance - Total revenue for Q2 2025 was $26.2 million, comprising $18.7 million from Viatris collaboration and $7.5 million from licensing revenue [10] - Viatris collaboration revenue increased by 31% year-over-year, amounting to $18.7 million in Q2 2025 [10] - Net income for Q2 2025 was $54.8 million, a significant improvement from a net loss of $16.5 million in Q2 2024 [10][30] - Non-GAAP net loss from operations was $4.2 million in Q2 2025, compared to a loss of $6.3 million in the same period in 2024 [10][30] Operational Highlights - YUPELRI net sales reached $66.3 million in Q2 2025, reflecting a 22% increase year-over-year [5][6] - The pivotal Phase 3 CYPRESS study for ampreloxetine is on track for enrollment completion by late summer 2025, with top-line data expected approximately six months later [5][10] - The company completed the sale of its TRELEGY royalty interest to GSK for $225 million, enhancing its financial position [5][10] Cash Position and Guidance - As of June 30, 2025, the company had $339 million in cash and no debt, indicating a strong balance sheet [5][10] - The company anticipates full-year 2025 global net sales to exceed $3.4 billion, with a milestone of $50 million from Royalty Pharma expected to be triggered [5][10] Strategic Focus - The company is focused on disciplined capital allocation and returning excess cash to shareholders, with ongoing evaluations of strategic alternatives to enhance shareholder value [7][10]

Core Viewpoint - Theravance Biopharma, Inc. is set to report its second quarter 2025 financial results and provide a business update on August 12, 2025, after market close [1] Company Overview - Theravance Biopharma focuses on delivering innovative medicines, including the FDA-approved YUPELRI® for chronic obstructive pulmonary disease (COPD) [3] - The company is developing Ampreloxetine, a late-stage investigational drug for neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA), which has the potential to be a first-in-class therapy [3] - Theravance Biopharma is committed to creating and driving shareholder value [3]

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]