Recent Updates
Recently added Catalysts
TBPH Negative Sentiment Score: 35/100

E xhibit 99.1 Theravance Biopharma Reports Phase 3 CYPRESS Study Did Not Meet Primary Endpoint; Board Accelerates Strategic Review and Announces Cost Reduction Actions Phase 3 CYPRESS study did not meet the primary endpo

Key Takeaway: Theravance Biopharma announced that its Phase 3 CYPRESS study did not meet the primary endpoint, leading the company to wind down the ampreloxetine program. In response, Theravance's Board is accelerating a strategic review and implementing significant cost reductions, expecting to cut operating expenses by about 60%. Despite this setback, the company remains optimistic about YUPELRI's performance and has a healthy cash balance projected at $400 million by Q1 2026, along with the potential for a $100 million milestone payment from TRELEGY.

Market Sentiment Analysis

POSITIVE FACTORS

  • Theravance has a cash balance of approximately $400 million.
  • YUPELRI is generating durable cash flow with expected growth.
  • The company expects a $100 million TRELEGY milestone payment in 2026.

CONCERNS & RISKS

  • The Phase 3 CYPRESS study did not meet its primary endpoint.
  • The company will wind down the ampreloxetine program due to poor study results.
  • Organizational restructuring will impact approximately 50% of the workforce.

Full Press Release Details

Phase 3 CYPRESS Study Did Not Meet Primary Endpoint;
Accelerates Strategic Review and Announces Cost Reduction Actions
Phase 3 CYPRESS study did not meet the primary endpoint, the OHSA Composite Score, a patient reported outcome (PRO)
Cash of $326.5 million at Q4 2025 (no debt); approximately $400 million expected at end of Q1 2026 including receipt of 2025 milestones; Theravance highly confident in achieving $100 million 2026 TRELEGY milestone 1
Strategic Review Committee accelerating ongoing efforts to evaluate alternatives to maximize shareholder value
Organizational restructuring to reduce cost base by approximately 60% (or approximately $70 million); expected to result in the Company generating approximately $60 - $70 million of annualized cash flow
Streamlined portfolio focused on YUPELRI , a growing product to treat COPD with durable cash-flow generation and long-dated intellectual property protection in the U.S. into 2039; FY 2025 net sales $266.6 million recognized by Viatris (+12% YoY) 2
IRELAND - March 3, 2026
- Theravance Biopharma, Inc. ("Theravance
Biopharma" or the "Company") (NASDAQ: TBPH) today announced topline results from the Phase 3 CYPRESS study evaluating
the efficacy and safety of ampreloxetine in patients with symptomatic neurogenic orthostatic hypotension (nOH) due to multiple system
atrophy (MSA), a rare disease. The study did not meet its primary endpoint in the Orthostatic Hypotension Symptom Assessment (OHSA) composite
score. As a result of this outcome, the Company has decided to wind down the ampreloxetine program.
connection with this announcement, the Strategic Review Committee of the Theravance Biopharma Board of Directors (the "Committee")
is accelerating its ongoing review of alternatives to maximize value for shareholders. Since its formation in 2024, the Committee has
been working on an ongoing basis with Lazard, its independent financial advisor, to evaluate opportunities available to the Company,
including under multiple potential outcomes for the CYPRESS study. Building upon this work, the Committee will act with urgency to evaluate
a broad range of value maximizing and tax efficient alternatives, including but not limited to a sale of the company. There can be no
assurance that the Committee's strategic review process will result in any transaction. Theravance Biopharma does not intend to
disclose further developments on this review process unless and until it determines that such disclosure is appropriate or necessary.
1 Payments from Royalty Pharma (RP)
will be triggered if RP receives certain minimum royalty payments from GSK based on TRELEGY global net sales.
2 In the U.S., Viatris is leading
the commercialization of YUPELRI, and the Company co-promotes the product under a profit and loss sharing arrangement (65% to Viatris;
35% to the Company).
the Committee accelerates its review, Theravance Biopharma is implementing an organizational restructuring to streamline costs and align
its resources with its commercial focus on YUPELRI . The restructuring will involve winding down the R&D function
and significantly reducing the G&A function. The restructuring is expected to reduce operating expenses by approximately 60%, relative
to 2025 preliminary actuals of approximately $110 million. The full run-rate cost savings of approximately $70 million are expected to
fully materialize in the third quarter of 2026.
the cost savings from the restructuring and continued sales from YUPELRI are expected to result in the Company
generating approximately $60 to $70 million of annualized cash flow, starting in Q3 2026. This cash flow projection is comprised of an
estimated $45 to $55 million of Income from Operations (excluding non-cash share-based compensation) and projected Interest and Other
Income, and does not include potential income from the $100 million TRELEGY milestone.
the decision to wind down the ampreloxetine program, the Company's sources of value include approximately $400 million of expected cash
at the end of Q1 2026, a 35% interest in YUPELRI that generates durable cash flow, and the potential TRELEGY milestone
payment, as well as Irish tax attributes.
are disappointed that ampreloxetine did not meet the primary endpoint in the CYPRESS study. These results are particularly disheartening
for the patients who are suffering from this rare disease and were hoping for a new treatment option and for the employees who dedicated
years of work to this program. I want to sincerely thank the patients, caregivers, investigators, and our team for their commitment and
contributions to this effort," said Rick E Winningham, Chief Executive Officer of Theravance Biopharma. "Given these results,
we are taking decisive steps to restructure the organization and significantly reduce our cost base, which we expect will allow YUPELRI
to drive meaningful and sustainable cash flow for the company. With a profitable commercial product, an expected cash balance of approximately
$400 million at the end of the first quarter of 2026, and the anticipated $100 million TRELEGY milestone in 2026, we continue to have
a strong set of assets."
with our commitment to act in the best interests of the Company and its shareholders, and alongside the organizational restructuring
actions we announced today, the Strategic Review Committee is accelerating its ongoing evaluation of value maximizing strategic alternatives,"
said Susannah Gray, independent Chair of the Board and Chair of the Strategic Review Committee. "The Committee was established
with a clear mandate to deliver maximum value to Theravance Biopharma shareholders, and over the last year and a half, has been actively
engaged in overseeing that the Company's strategy delivers on this objective, including with the $225 million sale of our remaining
royalty interest in TRELEGY in 2025. Today, Theravance Biopharma has a cash-generative commercial asset, strong balance sheet and sizable
near-term milestone payout opportunity, and the Committee is squarely focused on acting with urgency and discipline to ensure that we
achieve the best outcome for shareholders."
3 CYPRESS Topline Data Study Results
the Phase 3 CYPRESS study, the primary endpoint, the change in OHSA composite score at Week 8 during the double-blind randomized withdrawal
period, was not statistically significant. Similar trends were observed in the secondary endpoints at week 8. Changes in blood pressure,
heart rate and norepinephrine levels confirmed a consistent pressor effect and reaffirmed ampreloxetine's biological activity.
Ampreloxetine was generally well tolerated, with safety findings consistent with prior studies, including no signal of worsening of supine
the Company proceeds with the orderly wind down of the ampreloxetine program, it will complete additional analyses of the CYPRESS dataset
and Phase 3 program, in consultation with external experts, to assess whether the data merits further regulatory discussion. This assessment
is intended to provide the Committee with additional clarity regarding any remaining value in ampreloxetine for Theravance shareholders.
There can be no assurance that any additional regulatory engagement will occur.
restructuring is expected to impact approximately 50% of the overall workforce. This reduction includes the complete wind-down of the
R&D organization and a decrease of approximately 50% in G&A employees. These actions will be implemented over the next two quarters,
and the Company expects to incur approximately $5 to $7 million in one-time cash severance costs related to these actions.
(revefenacin) inhalation solution, the first and only once-daily, nebulized LAMA (long-acting muscarinic antagonist) bronchodilator approved
in the U.S. for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD):
Quarterly U.S. net sales of $70.6 million in Q4 2025, increasing 6% year-over-year (YoY) (Q4 2025 vs Q4 2024) 3 .
Annual U.S. net sales of $266.6 million, increasing 12% year-over-year (YoY) (FY 2025 vs FY 2024) triggering $25 million sales-based milestone from VIATRIS with cash received in January 2026.
GSK reported FY 2025 global TRELEGY net sales of approximately $3.91 billion 4 , meeting the threshold for a $50 million milestone from Royalty Pharma, with cash received in February 2026.
Company expects FY 2026 global net sales of at least approximately $3.51 billion, which will trigger an additional $100 million milestone from Royalty Pharma.
3 In the U.S., Viatris is leading
the commercialization of YUPELRI, and the Company co-promotes the product under a profit and loss sharing arrangement (65% to Viatris;
35% to the Company).
4 GSK-reported Net Sales in USD.
Cash totaled $326.5 million as of December 31, 2025, with no debt.
The Company received a $25 million YUPELRI U.S. sales milestone from Viatris in January 2026 and a $50 million TRELEGY milestone from Royalty Pharma in February 2026.
After receiving the TRELEGY and YUPELRI milestones in Q1 2026, the Company expects to have approximately $400 million in cash at the end of Q1 2026.
The Company also benefits from approximately $2.6 billion of Irish tax attributes.
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 (Study 0197), a Phase 3 Study
0197 (NCT05696717) 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. Secondary endpoints include change from baseline in Orthostatic
Hypotension Daily Activity Scale (OHDAS) composite score, OHDAS item 1 (activities that require standing for a short time) and OHDAS
item 3 (activities that require walking for a short time).
Theravance Biopharma
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).
The Company is committed to creating/driving shareholder value.
more information, please visit www.theravance.com.
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).
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.
Financial and Operating Results
financial information in this press release is preliminary, unaudited, based on currently available information, and subject to adjustment
in the final financial statements to be filed with the Company's Annual Report on Form 10-K for the year ended December 31, 2025. The
preliminary results set forth above reflect preliminary, unaudited estimates based solely on currently available information, which is
subject to change. Such preliminary results are subject to the finalization of year-end financial and accounting procedures. While carrying
out such procedures, the Company may identify items that would require it to make adjustments to the preliminary estimates of financial
results set forth herein. As a result, the Company's actual financial results could differ from the information set forth herein
and such differences could be material. Moreover, preliminary and estimated financial results should not be viewed as a substitute for
the Company's full annual financial statements for the year ended December 31, 2025, which will be prepared in accordance with
press release contains 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

Frequently Asked Questions

What was the result of the Phase 3 CYPRESS study?

The Phase 3 CYPRESS study did not meet its primary endpoint, the OHSA composite score.

What steps is Theravance Biopharma taking after the CYPRESS results?

Theravance Biopharma is restructuring its organization and winding down the ampreloxetine program.

What is the expected cash flow for Theravance Biopharma by Q3 2026?

The company expects to generate approximately $60 to $70 million in annualized cash flow.

How much cash does Theravance Biopharma have as of Q4 2025?

Theravance Biopharma had $326.5 million in cash with no debt as of Q4 2025.

What is the future focus of Theravance Biopharma?

The company will focus on YUPELRI, aiming for durable cash-flow generation in COPD treatment.

Last updated: Mar 3, 2026