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Theravance Biopharma(TBPH) - 2024 Q3 - Quarterly Results
2024-11-12 21:08
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 ...
Theravance Biopharma, Inc. Reports Third Quarter 2024 Financial Results and Announces Initiatives to Unlock Shareholder Value
Prnewswire· 2024-11-12 21:05
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 ...
Theravance Biopharma to Report Third Quarter 2024 Financial Results on November 12, 2024
Prnewswire· 2024-10-24 10:00
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 ...
Theravance Announces Publication of YUPELRI® (revefenacin) Area Under the Curve Spirometry Analysis in the International Journal of Chronic Obstructive Pulmonary Disease
Prnewswire· 2024-10-18 13:00
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 ...
Theravance Bio (TBPH) Up 2.2% Since Last Earnings Report: Can It Continue?
ZACKS· 2024-09-04 16:35
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 ...
Theravance Biopharma(TBPH) - 2024 Q2 - Quarterly Report
2024-08-08 20:57
Company Overview - Theravance Biopharma is focused on developing and commercializing medicines, with YUPELRI® (revefenacin) approved for COPD maintenance treatment in the US[67]. Sales Performance - YUPELRI net sales for the three months ended June 30, 2024, were $54.5 million, a 1% decrease from $55.0 million in the same period last year, while six-month net sales increased by 8% to $109.8 million[75]. - Theravance Biopharma's COPD market share grew, with hospitals surpassing 18% and community settings reaching 32% market share in the second quarter of 2024[75]. - TRELEGY global net sales for the six months ended June 30, 2024 were $1.81 billion, representing a 37% year-over-year growth, with total 2023 sales at $2.74 billion, a 28% increase[84]. Financial Milestones and Royalties - The company is eligible for up to $205 million in global development, regulatory, and sales milestone payments from Viatris, with $160 million related to YUPELRI monotherapy[71]. - In the China Region, Theravance Biopharma could receive tiered royalties on net sales of nebulized revefenacin, ranging from 14% to 20% based on annual sales thresholds[73]. - Royalty Pharma invested up to $40.0 million in ampreloxetine, with a $25.0 million upfront payment and a $15.0 million payment upon regulatory approval, receiving royalties of 2.5% on sales up to $500.0 million and 4.5% on sales over that amount[81]. - As of June 30, 2024, $200.0 million in potential milestone payments remain available, with eligibility for $25.0 million if TRELEGY global net sales reach approximately $2.86 billion in 2024[83]. - The royalty rates for TRELEGY are tiered from 6.5% to 10% based on annual global net sales, with specific thresholds outlined[87]. Research and Development - Ampreloxetine, an investigational drug for symptomatic neurogenic orthostatic hypotension in MSA patients, is advancing to a Phase 3 study following positive results from earlier trials[76][80]. - The REDWOOD Phase 3 study for ampreloxetine did not meet its primary endpoint, but subgroup analysis indicated benefits for MSA patients[79]. - The company anticipates the final patient enrollment for the additional Phase 3 study of ampreloxetine in mid-2025, with top-line data expected approximately six months later[80]. - R&D expenses increased by $0.5 million for the three months ended June 30, 2024, primarily due to increased employee-related and external costs related to the ampreloxetine Phase 3 study[95]. Operating Expenses - SG&A expenses for the three months ended June 30, 2024 were $9.95 million, a 6% increase compared to the prior year[98]. - Employee-related costs in SG&A increased by 16% for the three months ended June 30, 2024, while share-based compensation decreased by 38%[98]. - Total SG&A expenses for the three months ended June 30, 2024, were $17.1 million, a decrease of 12% compared to $19.3 million in the prior year[100]. - Excluding share-based compensation, total SG&A expenses for the six months ended June 30, 2024, were $25.8 million, down 13% from $29.8 million in the prior year[101]. Financial Position - As of June 30, 2024, the company had approximately $96.1 million in cash, cash equivalents, and investments in marketable securities, with no long-term debt[110]. - Net cash used in operating activities for the six months ended June 30, 2024, was $5.4 million, a decrease of 77% from $23.7 million in the prior year[112]. - Net cash provided by investing activities was $14.0 million for the six months ended June 30, 2024, compared to a net cash outflow of $32.0 million in the prior year[113]. - Net cash used in financing activities was $1.8 million for the six months ended June 30, 2024, a significant decrease from $136.9 million in the prior year[116]. Tax and Interest - The provision for income tax expense for the six months ended June 30, 2024, was $2.6 million, a significant increase of 142% from $1.1 million in the prior year[109]. - Interest expense for the three months ended June 30, 2024, was $0.6 million, representing a 13% increase compared to $0.5 million in the prior year[106]. - Interest income and other income (expense), net, decreased by 55% to $1.1 million for the three months ended June 30, 2024, compared to $2.5 million in the prior year[107].
Theravance (TBPH) Q2 Loss Wider Than Expected, Revenues Rise Y/Y
ZACKS· 2024-08-06 16:01
Theravance Biopharma, Inc. (TBPH) reported a second-quarter 2024 adjusted net loss of 13 cents per share, which was wider than the Zacks Consensus Estimate of a loss of 9 cents per share. In the year-ago quarter, the company had reported a loss of 13 cents 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 34 cents per share in the second quar ...
Theravance Biopharma(TBPH) - 2024 Q2 - Earnings Call Transcript
2024-08-05 23:37
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]
Theravance Biopharma(TBPH) - 2024 Q2 - Quarterly Results
2024-08-05 20:16
Exhibit 99.1 Theravance Biopharma, Inc. Reports Second Quarter 2024 Financial Results and Provides Business Update · Q2 2024 YUPELRI (revefenacin) net sales of $54.5 million, recognized by Viatris, decreased 1% from Q2 2023 · Viatris collaboration revenue of $14.3 million, increased 4% versus Q2 2023 · Partner Viatris submitted YUPELRI NDA in China; $7.5 million milestone if approved · Now expecting last patient into the open label portion of CYPRESS in mid-2025, top line data anticipated approximately 6 mo ...
Theravance Biopharma to Participate in an Upcoming Investor Conference
Prnewswire· 2024-07-25 10:00
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 ...