Theravance Biopharma, Inc. Reports Third Quarter 2024 Financial Results and Announces Initiatives to Unlock Shareholder Value
Theravance Biopharma (NASDAQ: TBPH) reported Q3 2024 results, highlighting strong performance in key areas. YUPELRI net sales reached $62.2M, a 7% YoY increase and 14% QoQ growth. TRELEGY sales hit $789M, up 17% YoY. The company formed a Strategic Review Committee to explore alternatives for unlocking shareholder value. R&D expenses were $9.3M, while SG&A expenses stood at $16.9M. A non-cash impairment charge of $1.6M was recorded. Net loss was $12.7M, impacted by the impairment. Cash reserves totaled $91.4M. The company expects R&D expenses of $30-36M and SG&A expenses of $45-55M for full-year 2024. A settlement agreement with Qilu resolved ongoing patent litigation over YUPELRI.
Theravance Biopharma (NASDAQ: TBPH) ha riportato i risultati del terzo trimestre 2024, evidenziando una forte performance in aree chiave. Le vendite nette di YUPELRI hanno raggiunto i 62,2 milioni di dollari, con un incremento del 7% rispetto all'anno precedente e del 14% rispetto al trimestre precedente. Le vendite di TRELEGY hanno toccato i 789 milioni di dollari, in aumento del 17% rispetto all'anno scorso. L'azienda ha costituito un Comitato di Revisione Strategica per esplorare alternative volte a sbloccare il valore per gli azionisti. Le spese per ricerca e sviluppo sono state di 9,3 milioni di dollari, mentre le spese SG&A si sono attestate a 16,9 milioni di dollari. È stata registrata una perdita per impairment non monetaria di 1,6 milioni di dollari. La perdita netta è stata di 12,7 milioni di dollari, influenzata dall'impairment. Le riserve di cassa ammontavano a 91,4 milioni di dollari. L'azienda prevede spese per R&D di 30-36 milioni di dollari e spese SG&A di 45-55 milioni di dollari per l'intero anno 2024. Un accordo di conciliazione con Qilu ha risolto una controversia sui brevetti relativa a YUPELRI.
Theravance Biopharma (NASDAQ: TBPH) reportó los resultados del tercer trimestre de 2024, destacando un sólido desempeño en áreas clave. Las ventas netas de YUPELRI alcanzaron $62.2M, con un aumento del 7% interanual y un crecimiento del 14% trimestral. Las ventas de TRELEGY alcanzaron $789M, un incremento del 17% interanual. La compañía formó un Comité de Revisión Estratégica para explorar alternativas para desbloquear el valor para los accionistas. Los gastos de I+D fueron de $9.3M, mientras que los gastos SG&A se sitúan en $16.9M. Se registró un cargo por deterioro no monetario de $1.6M. La pérdida neta fue de $12.7M, afectada por el deterioro. Las reservas de efectivo totalizaron $91.4M. La compañía espera gastos de I+D de $30-36M y gastos SG&A de $45-55M para el año completo 2024. Un acuerdo de conciliación con Qilu resolvió la litigación de patentes sobre YUPELRI.
Theravance Biopharma (NASDAQ: TBPH)는 2024년 3분기 실적을 발표하며 주요 분야에서 강력한 성과를 강조했습니다. YUPELRI의 순매출은 6220만 달러에 이르며, 전년 대비 7%, 직전 분기 대비 14% 증가했습니다. TRELEGY의 매출은 7억8900만 달러에 달하며, 전년 대비 17% 증가했습니다. 회사는 주주 가치를 unlock하기 위한 대안을 모색하기 위해 전략적 검토 위원회를 구성했습니다. 연구개발 비용은 930만 달러였고, 판매 및 관리 비용은 1690만 달러로 나타났습니다. 160만 달러의 비현금 손상차손이 기록되었습니다. 순손실은 1270만 달러로 손상을 영향을 받았습니다. 현금 유보액은 9140만 달러였습니다. 회사는 2024년 전체에 대해 3000만~3600만 달러의 연구개발 비용과 4500만~5500만 달러의 판매 및 관리 비용을 예상하고 있습니다. Qilu와의 합의는 YUPELRI에 대한 지속적인 특허 소송을 해결했습니다.
Theravance Biopharma (NASDAQ: TBPH) a annoncé les résultats du troisième trimestre 2024, mettant en avant une performance solide dans des domaines clés. Les ventes nettes de YUPELRI ont atteint 62,2 millions de dollars, soit une augmentation de 7 % par rapport à l'année précédente et de 14 % par rapport au trimestre précédent. Les ventes de TRELEGY se sont élevées à 789 millions de dollars, en hausse de 17 % par rapport à l'année précédente. L'entreprise a formé un Comité de Révision Stratégique pour explorer des alternatives afin de libérer la valeur pour les actionnaires. Les dépenses de R&D ont été de 9,3 millions de dollars, tandis que les dépenses SG&A se sont élevées à 16,9 millions de dollars. Une charge d'amortissement non monétaire de 1,6 million de dollars a été enregistrée. La perte nette s'est élevée à 12,7 millions de dollars, impactée par la dépréciation. Les réserves de liquidités totalisaient 91,4 millions de dollars. L'entreprise prévoit des dépenses de R&D de 30 à 36 millions de dollars et des dépenses SG&A de 45 à 55 millions de dollars pour l'année entière 2024. Un accord de règlement avec Qilu a résolu le contentieux en cours sur le brevet de YUPELRI.
Theravance Biopharma (NASDAQ: TBPH) hat die Ergebnisse des dritten Quartals 2024 veröffentlicht und hebt eine starke Leistung in Schlüsselbereichen hervor. Die Nettoumsätze von YUPELRI erreichten 62,2 Millionen US-Dollar, was einem Anstieg von 7 % im Jahresvergleich und 14 % im Vergleich zum vorherigen Quartal entspricht. Der Umsatz von TRELEGY betrug 789 Millionen US-Dollar, was einem Anstieg von 17 % im Jahresvergleich entspricht. Das Unternehmen bildete einen Strategischen Prüfungsausschuss, um Alternativen zur Freisetzung des Aktionärswertes zu prüfen. Die F&E-Kosten betrugen 9,3 Millionen US-Dollar, während die allgemeinen Verwaltungskosten bei 16,9 Millionen US-Dollar lagen. Es wurde eine nicht zahlungswirksame Wertberichtigung von 1,6 Millionen US-Dollar erfasst. Der Nettoverlust betrug 12,7 Millionen US-Dollar, beeinflusst durch die Wertberichtigung. Die Barreserven beliefen sich auf 91,4 Millionen US-Dollar. Das Unternehmen rechnet für das gesamte Jahr 2024 mit F&E-Ausgaben zwischen 30 und 36 Millionen US-Dollar sowie SG&A-Ausgaben zwischen 45 und 55 Millionen US-Dollar. Ein Vergleich mit Qilu hat den laufenden Patentstreit über YUPELRI beigelegt.
- YUPELRI net sales of $62.2M, a 7% YoY increase and 14% QoQ growth.
- TRELEGY net sales of $789M, a 17% YoY increase.
- Formation of a Strategic Review Committee to unlock shareholder value.
- Cash reserves of $91.4M.
- Net loss of $12.7M in Q3 2024.
- Non-cash impairment charge of $1.6M on long-lived assets.
- Increased R&D expenses to $9.3M and SG&A expenses to $16.9M.
- Third quarter results highlight strong operational performance across key value drivers:
- YUPELRI® (revefenacin) net sales of
$62.2 million 7% versus Q3 2023 and14% versus Q2 20241 - CYPRESS enrollment in-line with expectations, with timelines on track
- TRELEGY net sales increased
17% , to$789 million - Q4 sales of at least
~ needed to earn$260 million $25 million - Q4 sales of at least
~ needed to earn$610 million $50 million
- Q4 sales of at least
- YUPELRI® (revefenacin) net sales of
- Board of Directors announces initiatives to unlock shareholder value and enhance corporate governance
Reflecting on the quarter's operational performance, Rick Winningham, Theravance Biopharma CEO commented, "Through our collaboration with Viatris, we achieved a strong quarter for YUPELRI demand and made progress on recent mix-related pricing headwinds, therein driving quarterly net sales to an all-time high. We believe we are well positioned to build on recent momentum and achieve continued YUPELRI growth, while continuing to pay careful attention to our cost structure." He continued, "In addition, we are pleased with the progress we made in CYPRESS this quarter and reaffirm our development timelines with a goal of making this important therapy available to patients."
Third Quarter Recent Highlights
YUPELRI® (revefenacin) inhalation solution, the first and only once-daily, nebulized LAMA (long-acting muscarinic antagonist) bronchodilator approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD):
- Realized total net sales of
$62.2 million 7% growth compared with Q3 2023 and14% sequential growth compared with Q2 2024.1 - Demand up
14% , (Q3 2024 vs Q3 2023) exceeding expectations and year-to-date trends.3 - Hospital doses sold increased by
40% (Q3 2024 vs Q3 2023).4 - Continued to achieve all-time market share highs within the long-acting nebulized segment of the COPD market, with hospital share approaching
19% and community share reaching32% , respectively.5 - In October, published YUPELRI FEV1 AUC6 analysis of registrational Phase 3 Studies 0126 and 0127, demonstrating a substantial peak response and confirming the significant and sustained improvements in lung function compared with placebo over 24 hours.7
Ampreloxetine, an investigational, once-daily norepinephrine reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA):
- CYPRESS open-label enrollment still targeted for completion in mid-2025, with data anticipated to be available approximately six months later.
- In September, presented data on the long-term safety of ampreloxetine in nOH at the 2024 International Congress of Parkinson's Disease and Movement Disorders®.
- Data indicate ampreloxetine was generally well tolerated with a low incidence of treatment-emergent adverse events and study withdrawals over approximately 9 months of exposure to ampreloxetine.
- In November, presented data from Study 0169 at the 2024 American Autonomic Society meeting highlighting the significant burden of symptomatic nOH and the high unmet needs in patients with MSA.
- MSA patients experienced higher baseline symptom burden, and reduced activities of daily living and quality of life, despite treatment with available pressor agents.
TRELEGY Update:
- GSK posted third quarter 2024 global net sales of approximately
$789 million 17% from$675 million $2.6 billion 30% from the same period in 2023). - Based on 2024 through 2026 performance, Theravance Biopharma is eligible to receive a total of up to
$200 million - Theravance estimates that the first milestone payment of
$25 million $2.9 billion ~ ).2$260 million - Theravance estimates that a second
$25 million $50 million $3.2 billion ~ ).2$610 million
- Theravance estimates that the first milestone payment of
Third Quarter Financial Results
- Revenue: Total revenue for the third quarter of 2024 was
$16.9 million $1.2 million 8% , in the third quarter compared to the same period in 2023, and by18% sequentially compared to Q2 2024. The Viatris collaboration revenue represents amounts receivable from Viatris and comprises the Company's35% share of net sales of YUPELRI, as well as its proportionate amount of the total shared commercial costs incurred by the two companies. The non-shared YUPELRI costs incurred by Theravance Biopharma are recorded within operating expenses. While Viatris records the total net sales of YUPELRI within its financial statements, Theravance Biopharma's implied35% share of net sales of YUPELRI for the third quarter of 2024 was$21.8 million 7% increase compared to the same period in 2023. - Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2024 were
$9.3 million $8.3 million $1.1 million - Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the third quarter of 2024 were
$16.9 million $16.1 million $3.9 million - Non-Cash Impairment of Long-Lived Assets: The Company incurred a non-cash impairment charge of
$1.6 million - Share-Based Compensation: Share-based compensation expenses for the third quarter of 2024 was
$5.0 million $6.3 million $1.1 million $3.9 million $2.0 million $4.3 million - Net Loss and Non-GAAP Net Loss from Operations8: Net loss was
$12.7 million $9.0 million $1.6 million $2.9 million $0.7 million - Cash Position: Cash, cash equivalents and marketable securities totaled
$91.4 million
2024 Financial Guidance
- Operating Expenses (excluding share-based compensation): The Company continues to expect full year 2024 R&D expenses of
$30 million $36 million $45 million $55 million - Share-Based Compensation: The Company continues to expect full year share-based compensation expenses of
$18 million $22 million - Non-GAAP Net Profit / Loss: The Company expects levels of both non-GAAP losses and cash burn in the second half to be similar to first half actuals 2024.
Formation of Strategic Review Committee & Enhanced Corporate Governance
The Board of Directors has formed a Strategic Review Committee (the "Committee") composed entirely of independent directors to assess all strategic alternatives available to the Company, including those related to YUPELRI, ampreloxetine and TRELEGY, with the objective of unlocking shareholder value. The Committee is chaired by Susannah Gray and includes Jeremy Grant, Dean Mitchell, Donal O'Connor, and Deepa Pakianathan. Lazard will be acting as financial advisor to assist in this review process.
There can be no assurance that the Company's strategic review process will result in any transaction. Theravance Biopharma has not set a timetable for completion of this process, and it does not intend to disclose further developments unless and until it determines that such disclosure is appropriate or necessary.
Additionally, as part of its ongoing review of its corporate governance policies, the Company announced today that it has separated the roles of Chair of the Board and Chief Executive Officer. The Company believes that the separation of these roles will allow management to sharpen its focus on operational goals, including growing YUPELRI and completing the CYPRESS study. The Board of Directors elected Susannah Gray as Chair of the Board of the Company, while Rick Winningham will continue as a member of the Board of Directors and Chief Executive Officer.
Settlement Agreement
On September 18, 2024, certain subsidiaries of Theravance Biopharma and Viatris, entered into a settlement agreement (the "Settlement Agreement") with Qilu Pharmaceutical Co., Ltd. and Qilu Pharma Inc. (together Qilu) relating to Theravance Biopharma's and Viatris' YUPELRI® (revefenacin) inhalation solution. The Settlement Agreement resolves ongoing patent litigation brought by Theravance Biopharma and Viatris against Qilu pursuant to the Hatch-Waxman Act based on Qilu's filing of an abbreviated new drug application (ANDA) seeking approval to market a generic version of YUPELRI® (revefenacin) inhalation solution prior to expiration of certain Orange Book listed patents.
Under the Settlement Agreement, Theravance and Viatris granted Qilu a royalty-free, non-exclusive, non-sublicensable, non-transferable license to manufacture and market Qilu's generic version of YUPELRI® (revefenacin) inhalation solution in
Conference Call and Live Webcast Today at 5:00 pm EST
Theravance Biopharma will hold a conference call and live webcast accompanied by slides today at 5:00 pm EST / 2:00 pm PST / 10:00 pm GMT. To participate in the live call by telephone, please register here. Those interested in listening to the conference call live via the internet may do so by visiting Theravance Biopharma's website at www.theravance.com, under the Investors section, Events and Presentations.
A replay of the webcast will be available on Theravance Biopharma's website for 30 days through December 12, 2024.
About Ampreloxetine
Ampreloxetine, an investigational, once-daily norepinephrine reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA). The unique benefits of ampreloxetine treatment reported in MSA patients from Study 0170 included an increase in norepinephrine levels, a favorable impact on blood pressure, clinically meaningful and durable symptom improvement, and no signal for supine hypertension. In the US, the Company has been granted an Orphan Drug Designation for ampreloxetine for the treatment of symptomatic nOH in patients with MSA and, if results from the ongoing Phase 3 CYPRESS study are supportive, plans to file an NDA for full approval in this indication.
About CYPRESS (Study 0197), a Phase 3 Study
Study 0197 (NCT05696717) is currently enrolling. This is a registrational Phase 3, multi-center, randomized withdrawal study to evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of treatment; the primary endpoint of the study is change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score. The Study includes four periods: screening, open label (12-week period, participants will receive a single daily 10 mg dose of ampreloxetine), randomized withdrawal (eight-week period, double-blind, placebo-controlled, participants will receive a single daily 10 mg dose of placebo or ampreloxetine), and a long-term treatment extension. Secondary outcome measures include change from baseline in Orthostatic Hypotension Daily Activity Scale (OHDAS) item 1 (activities that require standing for a short time) and item 3 (activities that require walking for a short time).
About Multiple System Atrophy (MSA) and Symptomatic Neurogenic Orthostatic Hypotension (nOH)
MSA is a progressive brain disorder that affects movement and balance and disrupts the function of the autonomic nervous system. The autonomic nervous system controls body functions that are mostly involuntary. One of the most frequent autonomic symptoms associated with MSA is a sudden drop in blood pressure upon standing (nOH).9 There are approximately 50,000 MSA patients in the US10 and 70
Neurogenic orthostatic hypotension (nOH) is a rare disorder defined as a fall in systolic blood pressure of ⩾20 mm Hg or diastolic blood pressure of ⩾10 mm Hg, within 3 minutes of standing. Severely affected patients are unable to stand for more than a few seconds because of their decrease in blood pressure, leading to cerebral hypoperfusion and syncope. A debilitating condition, nOH results in a range of symptoms including dizziness, lightheadedness, fainting, fatigue, blurry vision, weakness, trouble concentrating, and head and neck pain.
About Theravance Biopharma
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 (COPD). Ampreloxetine, its late-stage investigational once-daily norepinephrine reuptake inhibitor in development for symptomatic neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA), has the potential to be a first in class therapy effective in treating a constellation of cardinal symptoms in MSA patients. The Company is committed to creating/driving shareholder value.
For more information, please visit www.theravance.com.
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).
YUPELRI® is a registered trademark of Mylan Specialty L.P., a Viatris company. Trademarks, trade names or service marks of other companies appearing in this press release are the property of their respective owners.
Forward-Looking Statements
This press release and the conference call will contain certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events. Theravance Biopharma intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to: the Company's expectations regarding its future profitability, expenses and uses of cash, the Company's goals, designs, strategies, plans and objectives, future growth of YUPELRI sales, future royalty payments, the ability to provide value to shareholders, the Company's regulatory strategies and timing of clinical studies, possible safety, efficacy or differentiation of our investigational therapy, the status of patent infringement litigation initiated by the Company and its partner against certain generic companies in federal district courts; contingent payments due to the Company from the sale of the Company's TRELEGY ELLIPTA royalty interests to Royalty Pharma, and expectations around the use of OHSA scores as endpoints for clinical trials. These statements are based on the current estimates and assumptions of the management of Theravance Biopharma as of the date of this press release and the conference call and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance Biopharma to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: factors that could increase the Company's cash requirements or expenses beyond its expectations and any factors that could adversely affect its profitability, whether the milestone thresholds can be achieved, delays or difficulties in commencing, enrolling or completing clinical studies, the potential that results from clinical or non-clinical studies indicate the Company's product candidates or product are unsafe, ineffective or not differentiated, risks of decisions from regulatory authorities that are unfavorable to the Company, dependence on third parties to conduct clinical studies, delays or failure to achieve and maintain regulatory approvals for product candidates, risks of collaborating with or relying on third parties to discover, develop, manufacture and commercialize products, and risks associated with establishing and maintaining sales, marketing and distribution capabilities with appropriate technical expertise and supporting infrastructure, the ability of the Company to protect and to enforce its intellectual property rights, volatility and fluctuations in the trading price and volume of the Company's shares, and general economic and market conditions. Other risks affecting Theravance Biopharma are in the Company's Form 10-Q filed with the SEC on August 8, 2024, and other periodic reports filed with the SEC. In addition to the risks described above and in Theravance Biopharma's filings with the SEC, other unknown or unpredictable factors also could affect Theravance Biopharma's results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance Biopharma assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.
Non-GAAP Financial Measures
Theravance Biopharma provides a non-GAAP profitability target and a non-GAAP metric in this press release. Theravance Biopharma believes that the non-GAAP profitability target and non-GAAP net profit (loss) from operations provide meaningful information to assist investors in assessing prospects for future performance and actual performance as they provide better metrics for analyzing the performance of its business by excluding items that may not be indicative of core operating results and the Company's cash position. Because non-GAAP financial targets and metrics, such as non-GAAP profitability and non-GAAP net loss from continuing operations, are not standardized, it may not be possible to compare these measures with other companies' non-GAAP targets or measures having the same or a similar name. Thus, Theravance Biopharma's non-GAAP measures should be considered in addition to, not as a substitute for, or in isolation from, the Company's actual GAAP results and other targets.
Please see the appendix attached to this press release for a reconciliation of non-GAAP net profit (loss) from operations to its corresponding measure, net profit (loss) from operations. A reconciliation of non-GAAP net profit (loss) from operations to its corresponding GAAP measure is not available on a forward-looking basis without unreasonable effort due to the uncertainty regarding, and the potential variability of, expenses and other factors in the future.
Contact:
investor.relations@theravance.com
650-808-4045
1 | In the US, Viatris is leading the commercialization of YUPELRI, and the Company co-promotes the product under a profit and loss sharing arrangement ( |
2 | The first payment of |
3 | Source: Viatris Customer Demand (Q3'24). |
4 | Source: IQVIA DDD, HDS, VA and Non-Reporting Hospital through Sep '24. |
5 | Hospital LA-NEB Market Share - IQVIA DDD through Sep '24. Community LA-NEB Market Share includes Retail + DME / Med B FFS through Jul '24. |
6 | Area under the forced expiratory volume in 1 second vs time curve. |
7 | LeMaster, W. B., Witenko, C. J., Lacy, M. K., Olmsted, A. W., Moran, E. J., & Mahler, D. A. (2024). Revefenacin Area Under the Curve Spirometry in Patients with Moderate to Very Severe COPD. International Journal of Chronic Obstructive Pulmonary Disease, 19, 2299–2308. https://doi.org/10.2147/COPD.S483176 |
8 | Non-GAAP profit (loss) consists of GAAP net income (loss) before taxes less share-based compensation expense, non-cash interest expense, and non-cash impairment expense. See the section titled "Non-GAAP Financial Measures" for more information. |
9 | https://medlineplus.gov/genetics/condition/multiple-system-atrophy/ |
10 | UCSD Neurological Institute (25K-75K, with ~10K new cases per year); NIH National Institute of Neurological Disorders and Stroke (15K-50K). |
11 | Delveinsight MSA Market Forecast (2023); Symptoms associated with orthostatic hypotension in pure autonomic failure and multiple systems atrophy, CJ Mathias (1999). |
THERAVANCE BIOPHARMA, INC. | |||||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||
(In thousands) | |||||
September 30, | December 31, | ||||
2024 | 2023 | ||||
Assets | (Unaudited) | (1) | |||
Current assets: | |||||
Cash and cash equivalents and short-term marketable securities | $ | 91,361 | $ | 102,426 | |
Receivables from collaborative arrangements | 16,845 | 17,474 | |||
Prepaid clinical and development services | 597 | 2,038 | |||
Other prepaid and current assets | 7,677 | 11,603 | |||
Total current assets | 116,480 | 133,541 | |||
Property and equipment, net | 7,788 | 9,068 | |||
Operating lease assets | 29,334 | 36,287 | |||
Future contingent milestone and royalty assets | 194,200 | 194,200 | |||
Restricted cash | 836 | 836 | |||
Other assets | 7,467 | 8,067 | |||
Total assets | $ | 356,105 | $ | 381,999 | |
Liabilities and Shareholders' Equity | |||||
Current liabilities | $ | 23,435 | $ | 24,767 | |
Long-term operating lease liabilities | 40,785 | 45,236 | |||
Future royalty payment contingency | 29,691 | 27,788 | |||
Unrecognized tax benefits | 71,563 | 65,294 | |||
Other long-term liabilities | 4,977 | 5,919 | |||
Shareholders' equity | 185,654 | 212,995 | |||
Total liabilities and shareholders' equity | $ | 356,105 | $ | 381,999 | |
(1) | The condensed consolidated balance sheet as of December 31, 2023 has been derived from the audited consolidated financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2023. |
THERAVANCE BIOPHARMA, INC. | ||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||
(In thousands, except per share data) | ||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||
(Unaudited) | (Unaudited) | |||||||||||
Revenue: | ||||||||||||
Viatris collaboration agreement (1) | $ | 16,868 | $ | 15,687 | $ | 45,627 | $ | 39,841 | ||||
Collaboration revenue | - | 6 | - | 18 | ||||||||
Total revenue | 16,868 | 15,693 | 45,627 | 39,859 | ||||||||
Costs and expenses: | ||||||||||||
Research and development (2) | 9,268 | 8,311 | 28,190 | 32,308 | ||||||||
Selling, general and administrative (2) | 16,875 | 16,142 | 50,673 | 54,603 | ||||||||
Impairment of long-lived assets (non-cash) | 1,562 | - | 4,513 | - | ||||||||
Restructuring and related expenses (2) | - | - | - | 2,743 | ||||||||
Total costs and expenses | 27,705 | 24,453 | 83,376 | 89,654 | ||||||||
Loss from operations | (10,837) | (8,760) | (37,749) | (49,795) | ||||||||
Interest expense (non-cash) | (630) | (609) | (1,903) | (1,727) | ||||||||
Interest income and other income (expense), net | 1,415 | 1,786 | 3,977 | 7,269 | ||||||||
Loss before income taxes | (10,052) | (7,583) | (35,675) | (44,253) | ||||||||
Provision for income tax expense | (2,646) | (1,367) | (5,216) | (2,430) | ||||||||
Net loss | $ | (12,698) | $ | (8,950) | $ | (40,891) | $ | (46,683) | ||||
Net loss per share: | ||||||||||||
Basic and diluted net loss per share | $ | (0.26) | $ | (0.17) | $ | (0.84) | $ | (0.81) | ||||
Shares used to compute basic and diluted net loss per share | 49,038 | 52,361 | 48,690 | 57,287 | ||||||||
Non-GAAP net loss | $ | (2,897) | $ | (712) | $ | (13,692) | $ | (22,979) | ||||
________________________________ | ||||||||||||
(1) While Viatris, Inc. records the total YUPELRI net sales, the Company is entitled to a | ||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
(In thousands) | 2024 | 2023 | 2024 | 2023 | ||||||||
YUPELRI net sales ( | $ | 62,189 | $ | 58,325 | $ | 171,945 | $ | 160,318 | ||||
YUPELRI net sales (Theravance Biopharma implied | 21,766 | 20,414 | 60,181 | 56,111 | ||||||||
(2) Amounts include share-based compensation expense as follows: | ||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
(In thousands) | 2024 | 2023 | 2024 | 2023 | ||||||||
Research and development | $ | 1,111 | $ | 2,004 | $ | 3,727 | $ | 6,301 | ||||
Selling, general and administrative | 3,852 | 4,258 | 11,840 | 12,890 | ||||||||
Restructuring and related expenses | - | - | - | 356 | ||||||||
Total share-based compensation expense | $ | 4,963 | $ | 6,262 | $ | 15,567 | $ | 19,547 | ||||
THERAVANCE BIOPHARMA, INC. | ||||||||||||
Reconciliation of GAAP to Non-GAAP Net Loss | ||||||||||||
(In thousands) | ||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||
(Unaudited) | (Unaudited) | |||||||||||
GAAP net loss | $ | (12,698) | $ | (8,950) | $ | (40,891) | $ | (46,683) | ||||
Adjustments: | ||||||||||||
Share-based compensation expense | 4,963 | 6,262 | 15,567 | 19,547 | ||||||||
Non-cash impairment of long-lived assets | 1,562 | - | 4,513 | - | ||||||||
Non-cash interest expense | 630 | 609 | 1,903 | 1,727 | ||||||||
Income tax expense | 2,646 | 1,367 | 5,216 | 2,430 | ||||||||
Non-GAAP net loss | $ | (2,897) | $ | (712) | $ | (13,692) | $ | (22,979) | ||||
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SOURCE Theravance Biopharma, Inc.
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