Full Press Release Details
DUBLIN , Aug. 5, 2024 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ: TBPH ) today announced financial and operational results for the second quarter of 2024.
"YUPELRI net sales decreased 1% from the prior quarter, owing to near-term headwinds from an evolved channel mix and a lower realized net price," said Rick Winningham , Theravance Biopharma CEO. "We are disappointed with this quarter's net sales result, but remain confident in our ability to continue to grow YUPELRI in the future, given strong and consistent demand generation." He continued, "In addition, while we have activated over 80% of study sites in CYPRESS and achieved solid enrollment in the quarter, we now anticipate enrolling the last patient into the open-label portion of the study in mid-2025. We continue to prioritize delivering a high-quality study in pursuit of making ampreloxetine available to those MSA patients suffering without viable treatment options for their symptomatic nOH. Finally, we are pleased with another exceptional quarter for TRELEGY, which increases our confidence in achieving milestones in 2024, which would contribute to our existing balance sheet strength."
Second Quarter Highlights
YUPELRI ® (revefenacin) inhalation solution, the first and only once-daily, nebulized LAMA (long- acting muscarinic agent) bronchodilator approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD):
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):
TRELEGY Update:
Second Quarter Financial Results
Updated 2024 Financial Guidance
Corporate Initiatives to Maximize Shareholder Value
Pursuant to a recently-completed review of its substantial Irish tax assets, the Company is engaging tax and financial advisors to explore opportunities through which to unlock value, given the gap between our share price and the value of our diverse and unique portfolio, including YUPELRI, ampreloxetine, TRELEGY and the Company's tax assets. We will provide further updates as appropriate.
Intellectual Property Updates
Additional Patent An additional method of use patent for YUPELRI was granted on July 30, 2024 , which expires in August 2039 , and is listed in the FDA Orange Book.
Conference Call and Live Webcast Today at 5:00 pm ET
Theravance Biopharma will hold a conference call and live webcast accompanied by slides today at 5:00 pm ET / 2:00 pm PT / 10:00 pm IST . 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 September 4, 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). 6 There are approximately 50,000 MSA patients in the US 7 and 70-90% of MSA patients experience nOH symptoms. 8 Despite available therapies, many MSA patients remain symptomatic with nOH.
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
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: [email protected] 650-808-4045
| THERAVANCE BIOPHARMA, INC. | |||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||||
| (In thousands) | |||||
| June 30, | December 31, | ||||
| 2024 | 2023 | ||||
| Assets | (Unaudited) | (1) | |||
| Current assets: | |||||
| Cash and cash equivalents and short-term marketable securities | $ | 96,078 | $ | 102,426 | |
| Receivables from collaborative arrangements | 14,299 | 17,474 | |||
| Prepaid clinical and development services | 2,646 | 2,038 | |||
| Other prepaid and current assets | 6,284 | 11,603 | |||
| Total current assets | 119,307 | 133,541 | |||
| Property and equipment, net | 8,142 | 9,068 | |||
| Operating lease assets | 31,815 | 36,287 | |||
| Future contingent milestone and royalty assets | 194,200 | 194,200 | |||
| Restricted cash | 836 | 836 | |||
| Other assets | 7,729 | 8,067 | |||
| Total assets | $ | 362,029 | $ | 381,999 | |
| Liabilities and Shareholders' Equity | |||||
| Current liabilities | $ | 22,946 | $ | 24,767 | |
| Long-term operating lease liabilities | 42,441 | 45,236 | |||
| Future royalty payment contingency | 29,061 | 27,788 | |||
| Unrecognized tax benefits | 69,007 | 65,294 | |||
| Other long-term liabilities | 4,885 | 5,919 | |||
| Shareholders' equity | 193,689 | 212,995 | |||
| Total liabilities and shareholders' equity | $ | 362,029 | $ | 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 June 30, | Six Months Ended June 30, | |||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||
| (Unaudited) | (Unaudited) | |||||||||||
| Revenue: | ||||||||||||
| Viatris collaboration agreement (1) | $ | 14,256 | $ | 13,743 | $ | 28,759 | $ | 24,154 | ||||
| Collaboration revenue | - | 6 | - | 12 | ||||||||
| Total revenue | 14,256 | 13,749 | 28,759 | 24,166 | ||||||||
| Costs and expenses: | ||||||||||||
| Research and development (2) | 9,954 | 9,425 | 18,922 | 23,997 | ||||||||
| Selling, general and administrative (2) | 17,056 | 19,278 | 33,798 | 38,461 | ||||||||
| Impairment of long-lived assets (non-cash) | 2,951 | - | 2,951 | - | ||||||||
| Restructuring and related expenses (2) | - | 1,169 | - | 2,743 | ||||||||
| Total costs and expenses | 29,961 | 29,872 | 55,671 | 65,201 | ||||||||
| Loss from operations | (15,705) | (16,123) | (26,912) | (41,035) | ||||||||
| Interest expense (non-cash) | (644) | (568) | (1,273) | (1,118) | ||||||||
| Interest income and other income (expense), net | 1,128 | 2,504 | 2,562 | 5,483 | ||||||||
| Loss before income taxes | (15,221) | (14,187) | (25,623) | (36,670) | ||||||||
| Provision for income tax expense | (1,308) | (1,458) | (2,570) | (1,063) | ||||||||
| Net loss | $ | (16,529) | $ | (15,645) | $ | (28,193) | $ | (37,733) | ||||
| Net loss per share: | ||||||||||||
| Basic and diluted net loss per share | $ | (0.34) | $ | (0.28) | $ | (0.58) | $ | (0.63) | ||||
| Shares used to compute basic and diluted net loss per share | 48,747 | 56,682 | 48,515 | 59,791 | ||||||||
| Non-GAAP net loss | $ | (6,250) | $ | (7,355) | $ | (10,795) | $ | (22,267) | ||||
| ________________________________ | ||||||||||||
| (1) While Viatris, Inc. records the total YUPELRI net sales, the Company is entitled to a 35% share of the net profit (loss) | ||||||||||||
| pursuant to a co-promotion agreement with Viatris as presented below: | ||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||
| (In thousands) | 2024 | 2023 | 2024 | 2023 | ||||||||
| YUPELRI net sales (100% recorded by Viatris) | $ | 54,530 | $ | 55,038 | $ | 109,756 | $ | 101,993 | ||||
| YUPELRI net sales (Theravance Biopharma implied 35%) | 19,085 | 19,263 | 38,415 | 35,697 | ||||||||
| (2) Amounts include share-based compensation expense as follows: | ||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||
| (In thousands) | 2024 | 2023 | 2024 | 2023 | ||||||||
| Research and development | $ | 1,151 | $ | 1,855 | $ | 2,616 | $ | 4,296 | ||||
| Selling, general and administrative | 4,225 | 4,409 | 7,988 | 8,632 | ||||||||
| Restructuring and related expenses | - | - | - | 357 | ||||||||
| Total share-based compensation expense | $ | 5,376 | $ | 6,264 | $ | 10,604 | $ | 13,285 |
| THERAVANCE BIOPHARMA, INC. | ||||||||||||
| Reconciliation of GAAP to Non-GAAP Net Loss | ||||||||||||
| (In thousands) | ||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||
| (Unaudited) | (Unaudited) | |||||||||||
| GAAP net loss | $ | (16,529) | $ | (15,645) | $ | (28,193) | $ | (37,733) | ||||
| Adjustments: | ||||||||||||
| Share-based compensation expense | 5,376 | 6,264 | 10,604 | 13,285 | ||||||||
| Non-cash impairment of long-lived assets | 2,951 | - | 2,951 | - | ||||||||
| Non-cash interest expense | 644 | 568 | 1,273 | 1,118 | ||||||||
| Income tax expense | 1,308 | 1,458 | 2,570 | 1,063 | ||||||||
| Non-GAAP net loss | $ | (6,250) | $ | (7,355) | $ | (10,795) | $ | (22,267) |
SOURCE Theravance Biopharma, Inc.