Third quarter results highlight strong operational performance across key value drivers: YUPELRI® (revefenacin) net sales of $62.2 million, recognized by Viatris, an all-time high, increased 7% versus Q3 2023 and 14% versus Q2 20241 CYPRESS enrollment in-line with expectations, with timelines on track TRELEGY net sales increased 17%, to $789 million, as reported by GSK: Q4 sales of at least ~$260 million needed to earn $25 million milestone2 Q4 sales of at least ~$610 million needed to earn $50 million m ...

DUBLIN, Oct. 24, 2024 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) will report its third quarter 2024 financial results and provide a business update after market close on Tuesday, November 12, 2024. An accompanying conference call and simultaneous webcast will be hosted at 5:00 pm EST (2:00 pm PST/10:00 pm GMT) that day.Conference Call InformationTo participate in the live call by telephone, please pre-register here. Those interested in listening to the conference call live via the internet ma ...

DUBLIN, Oct. 18, 2024 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) today announced the publication of a sub-study of the pivotal 12-week, randomized, registrational revefenacin Phase 3 trials (Trials 0126 [NCT02459080] and 0127 [NCT02512510]) for YUPELRI, the first and only FDA approved once-daily nebulized long-acting muscarinic antagonist (LAMA), evaluating the area under the curve (AUC) lung function effects in moderate-to-very-severe chronic obstruc ...

A month has gone by since the last earnings report for Theravance Biopharma (TBPH) . Shares have added about 2.2% in that time frame, underperforming 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 the most recent earnings report in order to get a better handle on the important drivers. Theravance's Q2 Loss Wider Than Expect ...

Core Viewpoint - Theravance Biopharma reported a wider adjusted net loss in Q2 2024 compared to estimates, with total revenues missing expectations despite a year-over-year increase due to collaboration revenues from Viatris [1][2]. Financial Performance - The adjusted net loss for Q2 2024 was 13 cents per share, exceeding the Zacks Consensus Estimate of a loss of 9 cents per share, and matching the loss reported in the same quarter last year [1] - Total revenues were $14.3 million, falling short of the Zacks Consensus Estimate of $16 million, but representing a 4.4% increase year-over-year [2] - The reported loss, including share-based compensation and other expenses, was 34 cents per share [2] Collaboration and Revenue Breakdown - Revenues were entirely derived from collaboration with Viatris related to Yupelri (revefenacin) sales, with Theravance receiving 35% of the profits from this collaboration [3][4] - Viatris recognizes product sales from Yupelri and also holds a stake in Theravance [4] Expense Analysis - Research and development expenses (excluding share-based compensation) totaled $8.8 million, an increase of 17.3% from the previous year [6] - Selling, general and administrative expenses (excluding share-based compensation) decreased by 13.4% year-over-year to $12.9 million [6] Cash Position and Guidance - As of June 30, 2024, Theravance had cash, cash equivalents, and marketable securities amounting to $96.1 million, down from $100 million as of March 31, 2024 [7] - The company expects adjusted R&D expenses to be in the range of $30-$36 million and adjusted SG&A expenses between $45 million and $55 million for 2024 [7] - Theravance anticipates that adjusted losses and cash burn for the remainder of 2024 will match the first half of the year, contrary to earlier expectations of breakeven in the second half [8] Pipeline Developments - Theravance is developing ampreloxetine (TD-9855) for neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA), which has received Orphan Drug designation from the FDA [9] - The phase III CYPRESS study for ampreloxetine began in Q1 2024, with patient enrollment expected to complete by mid-2025, and top-line data anticipated six months post-enrollment [10]

Financial Data and Key Metrics Changes - The company reported $54.5 million in net sales for YUPELRI, reflecting a 1% year-over-year decrease despite a 43% increase in hospital doses and a 13% increase in overall customer demand [3][8][10] - Collaboration revenue was reported at $14.3 million, representing a 4% year-over-year growth, although this was below internal expectations due to pricing dynamics affecting net sales [29][30] - The company ended the quarter with $96 million in cash and no debt, with operating expenses and cash burn metrics in line with expectations [7][30] Business Line Data and Key Metrics Changes - YUPELRI's net sales performance showed a 1% decline quarter-on-quarter and year-on-year, driven by lower realized net prices due to an evolved channel mix [8][10] - Hospital doses shipped increased by 43% year-on-year, reaching an all-time high, indicating strong demand generation [11] - The company reported an increase in market share for long-acting net market, with hospital share surpassing 18% and community share reaching 32% [12] Market Data and Key Metrics Changes - The company anticipates a more stable pricing environment for YUPELRI in 2025 and beyond, with continued demand growth expected across all patient fulfillment channels [4][10] - The potential introduction of YUPELRI in China is highlighted as a significant opportunity, with the market being the second largest globally for respiratory medications [16][17] Company Strategy and Development Direction - The company aims to grow YUPELRI in the U.S. and sees a clear path forward, focusing on hospital strategies and concomitant messaging to drive adoption [34] - The company is executing a well-designed development regulatory strategy for Ampreloxetine, with expectations for key milestones in the CYPRESS study [35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth potential of YUPELRI, despite short-term pricing challenges, and anticipates improvements in pricing dynamics in 2025 [37][50] - The company remains optimistic about achieving significant milestones in the near term, particularly related to Trelegy, with sales trajectory showing positive trends [34] Other Important Information - The company incurred a $3 million non-cash impairment charge due to the write-down in the value of operating lease assets, which is expected to be a one-time charge [30] - The company is managing the CYPRESS study internally to ensure high-quality results and has encountered longer timelines for site activations [20][24] Q&A Session Summary Question: Update on YUPELRI pricing dynamics - Management noted that the channel mix has shifted, impacting gross to net pricing, and anticipates slight price increases in the second half of the year [36][37] Question: Details on channel mix effects - Management explained that varied discounting ranges across different channels contribute to the channel mix dynamics [38][39] Question: Update on Paragraph IV litigations for YUPELRI - Management provided a brief update on ongoing litigation, noting settlements with some litigants and the addition of a new patent for YUPELRI [43][44] Question: Clarification on CYPRESS study timeline - Management confirmed that top-line data from the CYPRESS study is expected approximately six months after the last patient is enrolled in mid-2025 [47][54]

About Theravance Biopharma THERAVANCE BIOPHARMA®, THERAVANCE® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries). DUBLIN, July 25, 2024 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) will participate in a fireside chat at the BTIG Virtual Biotechnology Conference on Tuesday, August 6 at 12:00 pm ET (9:00 am PT/5:00 pm IST). Members of Theravance Biopharma senior management will also be hosting one-on-one meeti ...

Conference Call Information A replay of the webcast will be available on Theravance Biopharma's website for 30 days through September 4, 2024. Theravance Biopharma, Inc.'s focus is to deliver Medicines that Make a Difference® in people's lives. In pursuit of its purpose, Theravance Biopharma leverages decades of expertise, which has led to the development of FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease ...

Prioritizing Resource Allocation Toward Ampreloxetine: Theravance is prioritizing the development of ampreloxetine, a norepinephrine reuptake inhibitor, for the treatment of symptomatic nOH in patients with MSA. The FDA has granted Orphan Drug designation to ampreloxetine for the treatment of symptomatic nOH in patients with MSA. Theravance has collaborated with Viatris (VTRS) for the commercialization of Yupelri, as a once-daily, nebulized treatment of chronic obstructive pulmonary disease (COPD) in the Un ...

Table of Contents Form 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-36033 (Mark One) Cayman Islands 98-1226628 (State or Other Jurisdiction of (I.R.S. Employer Incorporation or Organizatio ...