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]

Financial Performance - YUPELRI net sales reached $62.2 million in Q3 2024, a 7% increase year-over-year, driven by a 14% rise in customer demand and market share growth to 19% in hospitals and 32% in community settings [95]. - TRELEGY global net sales for Q3 2024 were $789 million, representing a 17% year-over-year growth, and total sales for the nine months ended September 30, 2024, were $2.60 billion, reflecting a 30% increase [106]. - The company recognized $16.9 million in revenue from the Viatris collaboration agreement for Q3 2024, an 8% increase year-over-year, and $45.6 million for the nine months ended September 30, 2024, a 15% increase [121]. - As of September 30, 2024, YUPELRI's implied 35% share of net sales was $21.8 million for Q3 and $60.2 million for the nine months ended [95]. - The provision for income tax expense increased by 94% to $(2.6) million for the three months ended September 30, 2024, compared to $(1.4) million in the prior year [134]. - As of September 30, 2024, the company had approximately $91.4 million in cash, cash equivalents, and investments in marketable securities, with no long-term debt [135]. - Net cash used in operating activities was $10.6 million for the nine months ended September 30, 2024, an improvement from $26.1 million in the prior year [139]. - Net cash used in financing activities decreased significantly to $2.1 million for the nine months ended September 30, 2024, compared to $168.3 million in the prior year [144]. Research and Development - Ampreloxetine is in Phase 3 development for treating symptomatic neurogenic orthostatic hypotension in MSA patients, with the first pivotal study not meeting its primary endpoint [97][98]. - The company initiated a Phase 3 clinical study (CYPRESS) for ampreloxetine in MSA patients with symptomatic nOH in Q1 2023, with top-line data expected in mid-2025 [102]. - R&D expenses for Q3 2024 totaled $9.27 million, a 12% increase compared to the prior year, driven by external-related costs associated with the ampreloxetine Phase 3 study [124]. - R&D expenses decreased by $4.1 million for the nine months ended September 30, 2024, compared to the prior year period, primarily due to the discontinuation of investment in research activities [125]. - The company is focused on executing the ampreloxetine registration Phase 3 study and preparing for the NDA filing process [112]. Strategic Initiatives - The company has formed a Strategic Review Committee to explore strategic alternatives aimed at unlocking shareholder value [83]. - The roles of Chair of the Board and CEO have been separated to enhance corporate governance and operational focus [84]. - The company completed the sale of its 85% economic interest in TRELEGY for approximately $1.11 billion, retaining rights to future milestone payments and royalties [104]. - As of September 30, 2024, there are $200 million in potential milestone payments available, with thresholds for the next payments based on TRELEGY global net sales of $2.86 billion and $3.21 billion, representing increases of approximately 4% and 17% compared to 2023 [105]. Product Development and Market Position - The FDA approved YUPELRI in November 2018 for the maintenance treatment of COPD, with ongoing market research indicating a stable demand for nebulized delivery among COPD patients [85]. - The Phase 4 study comparing YUPELRI to Spiriva did not meet its primary endpoint, but YUPELRI maintained an efficacy and safety profile consistent with previous studies [94]. - The company retains worldwide rights to revefenacin in other dosage forms, while Viatris leads commercialization efforts in the US [88]. - In the China Region, the company could receive tiered royalties on net sales of nebulized revefenacin, ranging from 14% to 20% based on annual sales thresholds [93]. - Royalty Pharma invested up to $40 million in ampreloxetine, including a $25 million upfront payment and a $15 million payment upon regulatory approval, with future royalties of 2.5% on sales up to $500 million and 4.5% on sales over that threshold [103]. - The company anticipates TRELEGY to generate global peak sales of $4 billion in 2026 according to Bloomberg consensus estimates [106]. Expenses and Financial Management - Total SG&A expenses were $16.9 million for the three months ended September 30, 2024, representing a 5% increase from $16.1 million in the prior year period [126]. - Excluding share-based compensation, total SG&A expenses for the nine months ended September 30, 2024, were $38.8 million, down from $41.7 million in the prior year, reflecting a 7% reduction [127]. - Non-cash impairment charges of $1.6 million and $4.5 million were recognized for the three and nine months ended September 30, 2024, respectively, related to vacant laboratory space [130]. - Interest expense was $0.6 million and $1.9 million for the three and nine months ended September 30, 2024, respectively, primarily due to non-cash interest associated with $25.0 million received from Royalty Pharma [132]. - Interest and other income decreased by $0.4 million and $3.3 million for the three and nine months ended September 30, 2024, respectively, due to reduced interest income from cash and marketable securities [133]. Upcoming Events - The company will hold its 2025 Annual General Meeting of Shareholders on May 19, 2025, in Dublin, Ireland [113].

Theravance Biopharma (TBPH) reported third-quarter 2024 adjusted net loss of 6 cents per share, narrower than the Zacks Consensus Estimate of a loss of 10 cents. In the year-ago quarter, the company had incurred an adjusted loss of 1 cent per share.The reported loss excludes share-based compensation expense, non-cash impairment of long-lived assets, income tax expense and non-cash interest expense. Including these items, the company reported a loss of 26 cents per share in the third quarter compared with a ...

Financial Data and Key Metrics Changes - Theravance Biopharma reported quarterly net sales for YUPELRI of $62.2 million, reflecting a 7% year-over-year growth and a 14% quarter-over-quarter increase, marking a new launch high [5][11] - Collaboration revenue reached $16.9 million, an 8% increase compared to the previous year, with total operating expenses slightly better than expectations [33][34] - The company closed the period with $91 million in cash and 49 million shares outstanding [35] Business Line Data and Key Metrics Changes - YUPELRI's demand increased by 14% and hospital doses rose by 40% year-over-year, contributing to a nearly 19% market share in the hospital long-acting Neb market [5][17] - Trelegy sales increased by 17% to $789 million for the quarter, with year-to-date sales reaching $2.6 billion, up 30% [22] - Ampreloxetine is progressing well in the CYPRESS study, with patient enrollment on track to meet objectives [26][27] Market Data and Key Metrics Changes - The company is optimistic about YUPELRI's growth potential in the U.S. and has filed an NDA in China, with potential milestones and royalties outlined [20][21] - The strategic objective includes expanding YUPELRI's utilization in the U.S. and exploring opportunities in international markets [39] Company Strategy and Development Direction - The Board has formed a strategic review committee to explore alternatives for unlocking value from key assets, including YUPELRI and Ampreloxetine [9][10] - The company aims to maximize the number of patients benefiting from YUPELRI and is focused on disciplined investment to drive long-term shareholder value [40][41] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about YUPELRI's growth trajectory and the potential for achieving sales milestones with Trelegy [6][40] - The company is committed to returning excess capital to shareholders and managing expenses carefully to limit cash utilization [10][40] Other Important Information - The company incurred a $1.6 million non-cash impairment charge related to excess lab space [35] - Management highlighted the importance of therapeutic interchange protocols in driving market share for YUPELRI [49] Q&A Session Summary Question: Changes in YUPELRI prescribing patterns post ensifentrine launch - Management noted anecdotal feedback indicating that ensifentrine is being added on to YUPELRI, with a focus on concomitant use [44] Question: Status of site activations for the CYPRESS study - Management confirmed that the majority of key sites are now activated, progressing as planned [45] Question: Drivers of YUPELRI's growth and expectations moving forward - Growth is attributed to formulary approvals and therapeutic interchange, with expectations for continued market share gains [48] Question: Rationale behind the newly formed strategic review committee - The Board is evaluating the company's strategy against both short-term and long-term goals, aiming to unlock value from key assets [50][52] Question: Progress on ASP and expectations for 2025 - Management indicated that improvements in ASP are expected to manifest in early 2025, driven by strong demand growth [56][57]

Core Insights - Theravance Biopharma reported a quarterly loss of $0.06 per share, better than the Zacks Consensus Estimate of a loss of $0.10, representing a 40% earnings surprise [1] - The company generated revenues of $16.87 million for the quarter ended September 2024, exceeding the Zacks Consensus Estimate by 4.71% and showing an increase from $15.69 million year-over-year [2] - The stock has underperformed, losing approximately 19.2% since the beginning of the year, while the S&P 500 has gained 25.8% [3] Financial Performance - Over the last four quarters, Theravance Biopharma has surpassed consensus EPS estimates three times and topped revenue estimates two times [2] - The current consensus EPS estimate for the upcoming quarter is -$0.05 on revenues of $34.22 million, and for the current fiscal year, it is -$0.45 on revenues of $79.17 million [7] Market Outlook - The Zacks Rank for Theravance Biopharma is currently 2 (Buy), indicating expectations for the stock to outperform the market in the near future [6] - The Medical - Drugs industry, to which Theravance belongs, is currently in the top 27% of Zacks industries, suggesting a favorable outlook compared to the bottom 50% [8]

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Exhibit 99.1 Theravance Biopharma, Inc. Reports Third Quarter 2024 Financial Results and Announces Initiatives to Unlock Shareholder Value · Third quarter results highlight strong operational performance across key value drivers: o YUPELRI (revefenacin) net sales of $62.2 million, recognized by Viatris, an all-time high, increased 7% versus Q3 2023 and 14% versus Q2 2024 o CYPRESS enrollment in-line with expectations, with timelines on track o TRELEGY net sales increased 17%, to $789 million, as reported by ...