LAMA

OhtuvayreTM (ensifentrine) recorded net product sales of $36.6 million in Q4 and $42.3 million in 2024 More prescriptions filled through February 2025 than in Q4 2024 Over 4,600 unique prescribers with ~55% of Tier 1 HCPs prescribing Ohtuvayre through February 2025 Phase 2 programs in bronchiectasis and fixed-dose combination in COPD advance Conference call today at 9:00 a.m. EST / 2:00 p.m. GMT LONDON and RALEIGH, N.C., Feb. 27, 2025 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), a biopharmaceutical company focused on respiratory diseases, announces its financial results for the fourth quarter and full year ended December 31, 2024, and provides a corporate update. “2024 was another transformational year for Verona Pharma with the US approval and launch of Ohtuvayre (ensifentrine), the first novel inhaled therapy available for the maintenance treatment of Chronic Obstructive Pulmonary Disease (“COPD”) in over 20 years,” said David Zaccardelli, Pharm. D., President and Chief Executive Officer. “We are very pleased to report the extremely strong start to the launch continues to build momentum with more prescriptions dispensed through February 2025 than in the entire fourth quarter of 2024. “More than 4,600 unique healthcare professionals (“HCPs”) including approximately 55% of our Tier 1 HCPs have prescribed Ohtuvayre. Additionally, to date, more than 275 HCPs have prescribed Ohtuvayre to over 20 patients in their practice. Ohtuvayre is being prescribed for maintenance therapy across a broad COPD population including those receiving background single, dual and approximately 50% on triple therapy. These data strengthen our belief that ensifentrine’s novel bronchodilator and non-steroidal anti-inflammatory activity will redefine the treatment paradigm for COPD. “Alongside our commercialization efforts, in the third quarter we initiated two Phase 2 clinical trials: a dose-ranging trial with glycopyrrolate, a long-acting muscarinic antagonist (“LAMA”), to support a nebulized fixed-dose combination of ensifentrine and glycopyrrolate for the maintenance treatment of COPD, and a study assessing the safety and efficacy of nebulized ensifentrine in patients with non-cystic fibrosis bronchiectasis (“bronchiectasis”). We are pleased to report the glycopyrrolate dose-ranging trial was successfully completed and we plan to initiate a dose ranging Phase 2b trial with a fixed-dose combination of ensifentrine and glycopyrrolate in the second half of 2025. “In addition to our successful Ohtuvayre launch, our development partner in Greater China, Nuance Pharma, announced in February 2025 that Ohtuvayre was approved in Macau, the first approval outside of the US, for the maintenance treatment of COPD. In addition, Nuance Pharma has completed enrollment in its own pivotal Phase 3 trial in China to evaluate ensifentrine for the maintenance treatment of COPD and expects to report results in mid-2025. “In 2025, we will continue to build on the successful commercialization of Ohtuvayre in the US while progressing our Phase 2 programs. We are also initiating activities with regulatory authorities in the European Union and the UK for potential marketing authorization application submissions for Ohtuvayre.” Program Updates and Key Milestones The Company’s near-term milestones include: In the second half of 2025, the Company plans to start a dose-ranging Phase 2b trial to assess the safety and efficacy of a fixed-dose nebulized combination of ensifentrine with glycopyrrolate. The Company has successfully completed a Phase 2 dose-ranging trial with glycopyrrolate to support this program. The Company continues to enroll subjects in a Phase 2 trial to assess the efficacy and safety of nebulized ensifentrine in patients with bronchiectasis. In 2025, the Company plans to progress the regulatory activities for potential marketing authorization application submissions for Ohtuvayre for the maintenance treatment of COPD in the European Union and in the UK. In mid-2025, the Company’s development partner in Greater China, Nuance Pharma, is expected to report results from its pivotal Phase 3 trial evaluating ensifentrine for the maintenance treatment of COPD in China. Fourth Quarter and Recent Highlights In October 2024, the Company gave four oral presentations and presented two posters on analyses from the ENHANCE studies at CHEST Annual Meeting 2024. These included subgroup data supporting improvements in lung function, symptoms and quality of life, as well as reductions in the rate of exacerbations, regardless of COPD severity (moderate or severe), smoking status (current or former) and chronic bronchitis (with or without). An analysis of Ohtuvayre’s impact on reducing exacerbation rates and COPD-related healthcare resource utilization was also presented. In November 2024, the 2025 GOLD report added Ohtuvayre to the COPD treatment algorithm. Also in November 2024, the Company completed enrollment in a Phase 2 dose-ranging trial with glycopyrrolate, a LAMA, supporting a fixed-dose combination program for the maintenance treatment of COPD via a nebulizer. On January 1, 2025, Ohtuvayre’s product specific J-code became effective. In February 2025, the Company’s development partner in Greater China, Nuance Pharma, announced Ohtuvayre has been approved in Macau for the maintenance treatment of COPD in adult patients. This is the first regulatory approval outside of the US. Fourth Quarter 2024 Financial Results Cash position: Cash and cash equivalents at December 31, 2024, were $399.8 million (December 31, 2023: $271.8 million). Product sales: Net sales of Ohtuvayre were $36.6 million for the fourth quarter ended December 31, 2024 (Q4 2023: $0 million). The Company received FDA approval on June 26, 2024 and the product was commercially available beginning in August 2024. Cost of sales: Cost of sales was $2.0 million for the fourth quarter ended December 31, 2024 (Q4 2023: $0 million), which included Ohtuvayre manufacturing costs incurred after US approval, inventory overhead costs and sales-based royalties. R&D Expenses: Research and development (“R&D”) expenses were $7.9 million for the fourth quarter ended December 31, 2024 (Q4 2023: $4.1 million). This increase of $3.8 million was primarily due to an increase of $3.2 million in clinical trial and other development costs as we initiated two Phase 2 studies in the third quarter of 2024 related to the combination of nebulized ensifentrine and glycopyrrolate and for Ohtuvayre in patients with bronchiectasis, and an increase of $1.1 million in share-based compensation. SG&A Expenses: Selling general and administrative expenses (“SG&A”) were $45.1 million for the fourth quarter ended December 31, 2024 (Q4 2023: $15.0 million). The increase of $30.1 million was driven primarily by an increase of $9.8 million in marketing and other commercial related activities, including travel, primarily related to the launch of Ohtuvayre, and an increase of $2.6 million in professional and consulting fees, information technology costs and other support costs due to the continued buildout of our commercial organization. Additionally, we had an increase of $8.8 million in people-related costs as we built out our commercial organization including much of the field sales team as well as an increase of $7.8 million related to share-based compensation. Net loss: Net loss was $33.8 million for the fourth quarter ended December 31, 2024 (Q4 2023: Net loss $14.1 million). Full Year 2024 Financial Results Product sales: Net sales were $42.3 million for the year ended December 31, 2024 (2023: $0 million) related to product sales of Ohtuvayre. Cost of sales: Cost of sales was $2.6 million for the year ended December 31, 2024 (2023: $0 million), which included Ohtuvayre manufacturing costs incurred after US approval, inventory overhead costs and sales-based royalties. R&D Expenses: R&D expenses were $44.6 million for the year ended December 31, 2024 (full year 2023: $17.2 million), an increase of $27.4 million. This increase was primarily due to an increase of $17.5 million in clinical trial and other development costs we incurred related to the two Phase 2 studies which were initiated in the third quarter of 2024 related to the combination of nebulized ensifentrine and glycopyrrolate and for Ohtuvayre in patients with bronchiectasis, the $6.3 million approval milestone, $3.1 million increase in share-based compensation, $2.0 million increase for people-related costs and $1.1 million related to pre-launch manufacturing costs for commercial supply. This was partially offset by a decrease of $1.3 million in consultant and professional fee costs which were higher in the prior year due to service costs associated with our New Drug Application and the related approval process. SG&A Expenses: SG&A expenses were $149.8 million for the year ended December 31, 2024 (full year 2023: $50.4 million), an increase of $99.4 million. This increase was driven primarily by an increase of $29.7 million in marketing and other commercial related activities, including travel, primarily related to the launch of Ohtuvayre, a charge of $15.0 million for the first sale milestone and an increase of $7.3 million in professional and consulting fees, information technology costs and other support costs due to the continued buildout of our commercial organization. Additionally, we had an increase of $26.8 million in people-related costs as we built out our commercial organization including much of the field sales team as well as an increase of $18.8 million related to share-based compensation. Net loss: Net loss was $173.4 million for the year ended December 31, 2024 (full year 2023: $54.4 million). Conference Call and Webcast Information Verona Pharma will host an investment community webcast and conference call at 9:00 a.m. EST / 2:00 p.m. GMT on Thursday, February 27, 2025, to discuss the fourth quarter and full year 2024 financial results and the corporate update. To participate, please dial one of the following numbers and ask to join the Verona Pharma call: +1-800-836-8184 for callers in the United States +1-646-357-8785 for international callers A live webcast will be available on the Events and Presentations link on the Investors page of the Company’s website, www.veronapharma.com, and the audio replay will be available for 90 days. An electronic copy of the fourth quarter and full year 2024 results press release will also be made available today on the Company’s website. Important Safety Information Indication Ohtuvayre is a prescription medicine used to treat COPD in adults. COPD is a chronic (long-term) lung disease that includes chronic bronchitis, emphysema, or both. What is the most important information I should know about Ohtuvayre? Ohtuvayre can cause serious side effects, including: Sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using Ohtuvayre and call your healthcare provider right away or go to the nearest hospital emergency room right away. Mental health problems including suicidal thoughts and behavior. You may experience mood or behavior changes when taking Ohtuvayre. Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts of suicide or dying, attempt to commit suicide, trouble sleeping (insomnia), new or worse anxiety, new or worse depression, acting on dangerous impulses, and/or other unusual changes in your behavior or mood. Do not use Ohtuvayre to treat sudden breathing problems. Always have a rescue inhaler with you. Who Should Not use Ohtuvayre? Do not use Ohtuvayre if you have had an allergic reaction to ensifentrine or any of the ingredients in Ohtuvayre. What should I tell my healthcare provider before using Ohtuvayre? Before you use Ohtuvayre, tell your healthcare professional if you have or have had a history of mental health problems including depression and suicidal behavior; have liver problems; are pregnant or plan to become pregnant; are breastfeeding. It is not known if Ohtuvayre may harm your unborn baby. It is not known if the medicine in Ohtuvayre passes into your breast milk and if it can harm your baby. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What are the most common side effects of Ohtuvayre? The most common side effects of Ohtuvayre include back pain, high blood pressure, bladder infection and diarrhea. These are not all the possible side effects of Ohtuvayre. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This summary does not include all the information about Ohtuvayre and is not meant to take the place of a discussion with your healthcare provider about your treatment. For further information, please see the full Prescribing Information, including the Patient Information Leaflet. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. For further information please contact: About Verona Pharma Verona Pharma is a biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs. OhtuvayreTM (ensifentrine) is the Company’s first commercial product and the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Ensifentrine has potential applications in non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements. Words such as “anticipate,” “believe,” “plan,” “expect,” “intend,” “may,” “potential,” “prepare,” “possible” and similar words and expressions are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the potential benefits and efficacy of our drug Ohtuvayre to treat adult patients in the US with COPD, statements regarding our two recently initiated Phase 2 clinical trials, the Company’s plans to initiate a Phase 2b clinical trial, potential regulatory approvals in the EU and UK, and Nuance Pharma’s results from its pivotal Phase 3 trial, and the timing of any of the foregoing. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from our expectations expressed or implied by the forward-looking statements, including, but not limited to, the following: risks related to our limited operating history; our need for additional funding to complete development and commercialization of Ohtuvayre which may not be available and which may force us to delay, reduce or eliminate our development or commercialization efforts; our reliance on the success of Ohtuvayre, our only commercial product; our reliance on third-party manufacturers and suppliers; the efficacy of Ohtuvayre compared to competing drugs; our ability to successfully commercialize Ohtuvayre; serious adverse, undesirable or unacceptable side effects associated with Ohtuvayre which could adversely affect our ability to commercialize Ohtuvayre; failure to develop Ohtuvayre for additional indications, alternate delivery methods, or as a combination therapy; failure to obtain approval for and commercialize Ohtuvayre in multiple major pharmaceutical markets; our commercial capabilities and infrastructure, including sales, marketing, operations, distribution, and reimbursement infrastructure, may not be adequate to successfully commercialize Ohtuvayre; lawsuits related to patents covering Ohtuvayre and the potential for our patents to be found invalid or unenforceable; lawsuits related to our licensing of patents and know-how from third parties for the commercialization of Ohtuvayre; changes in our tax rates, unavailability of certain tax credits or reliefs or exposure to additional tax liabilities or assessments that could affect our profitability, and audits by tax authorities that could result in additional tax payments for prior periods; the terms of our credit agreement and the revenue interest purchase and sale agreement (“RIPSA”) place restrictions on our operating and financial flexibility, and if we fail to comply with certain covenants in the RIPSA, our results of operations and financial condition may be harmed; our vulnerability to natural disasters, global economic factors, geo-political actions and unexpected events, including health epidemics or pandemics; and the other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the period ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on February 27, 2025, as such factors may be updated from time to time in our other filings with the SEC. We disclaim any obligation to update or revise any forward-looking statement contained in this press release, even if subsequent events cause our views to change, except as required under applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Verona Pharma plc Consolidated Financial Summary (unaudited) (in thousands, except share and per share amounts)

YUPELRI® (revefenacin) US net sales, recognized by Viatris, reached an all-time high of $66.7 million in Q4 2024 and $238.6 million in FY 2024, up 10% and 8%, respectively, compared with 20231 FY 2024 TRELEGY Net Sales, as reported by GSK, of $3.46 billion, up 26% compared with 2023 and triggering a $50 million milestone to Theravance Biopharma2,3 CYPRESS study on track to enroll final patient in the open label portion by mid-2025 Ended Q4 2024 with $88 million in cash, excluding the $50 million TRELEGY milestone, with cash receipt in February 2025 DUBLIN, Feb. 26, 2025 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) today announced financial and operational results for the fourth quarter and full-year ended December 31, 2024. "Theravance Biopharma ended 2024 on a high note, having collaborated closely with Viatris to deliver record fourth quarter YUPELRI net sales and profitability, while achieving $50 million in TRELEGY related sales milestones," said Rick E Winningham, Theravance Biopharma CEO. "Our hospital-based commercial organization executed particularly well through the end of the year, positioning us to continue driving YUPELRI growth in 2025 and beyond. These achievements, coupled with steady progress towards enrolling the last patient in the open label portion of our pivotal CYPRESS Study by mid-2025 and additional potential YUPELRI and TRELEGY milestones in the coming 12-24 months, highlight the multiple components of value created by our ongoing strategy." Portfolio 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): Achieved total US net sales of $66.7 million in Q4 2024, increasing 10% year-over-year (Q4 2024 vs Q4 2023), driven by increased customer demand.1,4 Achieved 2024 total US net sales of $238.6 million, up 8% year-over-year; Theravance Biopharma stands to receive a one-time $25 million milestone payment from Viatris for the first calendar year in which YUPELRI achieves at least $250 million in US net sales, which would represent 4% growth from 2024 levels. Reached launch-to-date highs in brand profitability during the fourth quarter and full year 2024. Grew customer demand 9% for the quarter (Q4 2024 vs Q3 2024) and 11% for the year.4 Grew Q4 2024 doses sold into the hospital channel by 49% year-over-year (Q4 2024 vs Q4 2023), capping off a record year for hospital performance.5 TRELEGY GSK posted Q4 2024 and FY 2024 global TRELEGY net sales of $853 million and $3.46 billion, up 16% and 26%, respectively, compared with prior-year periods.2 FY 2024 global net sales of $3.46 billion sufficient to trigger $50M milestone from Royalty Pharma, with cash received in February 2025. FY 2024 global net sales of $3.46 billion would exceed the threshold required to achieve $50 million of milestones in 2025 (based on $3.41 billion of net sales) with only 2% growth required to achieve $100 million of milestones in 2026 (based on $3.51 billion of net sales). Royalties of up to 8.5% on TRELEGY net sales return to Theravance Biopharma in eligible territories beginning mid-2029, a significant driver of long-term value. 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): On track to enroll the final patient in the open label portion of the CYPRESS in mid-2025, with top-line data anticipated to be available approximately six months later. Continue to prepare for an expedited NDA filing post CYPRESS readout and plan to request a priority review. Recent successful interaction with FDA confirming agreement on the content of a complete application, solidifying our path to an NDA. Two abstracts accepted for oral presentation at the American Academy of Neurology 2025 Annual Meeting taking place April 5–9, 2025, in San Diego: "The Impact of Ampreloxetine on Supine Hypertension: An Ambulatory Blood Pressure Monitoring Study" "NET-Inhibition with Ampreloxetine, Blood Pressure, and Catecholamines in Patients with Neurogenic Orthostatic Hypotension" Continued launch readiness activities, including primary provider-focused research. Initial findings confirm strong need for more effective therapies with greater durability in nOH in MSA, as well as existence of many MSA patients with persistent symptoms despite available therapies. Fourth Quarter Financial Results Revenue: Total revenue for the fourth quarter of 2024 was $18.8 million, consisting entirely of Viatris collaboration revenue. Viatris collaboration revenue increased by $1.4 million, or 8%, in the fourth quarter compared to the same period in 2023 due primarily to higher net sales. The Viatris collaboration revenue represents amounts receivable from Viatris and comprises the Company's 35% share of net sales of YUPELRI, as well as its proportionate amount of the total shared 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 implied 35% share of net sales of YUPELRI for the fourth quarter of 2024 was $23.3 million which represents a 10% increase compared to the same period in 2023. Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2024 were $9.5 million, compared to $8.3 million in the same period in 2023. Fourth quarter R&D expenses included total non-cash share-based compensation of $1.4 million. In terms of Financial Guidance, full year 2024 R&D expenses excluding non-cash share-based compensation were $32.5 million which was within our Financial Guidance of $30 million to $36 million. Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the fourth quarter of 2024 were $18.5 million, compared to $15.5 million in the same period in 2023. Fourth quarter SG&A expenses included total non-cash share-based compensation of $4.4 million. In terms of Financial Guidance, full year 2024 SG&A expenses excluding non-cash share-based compensation were $52.9 million which was within our Financial Guidance of $45 million to $55 million. Share-Based Compensation: Share-based compensation expenses for the fourth quarter of 2024 were $5.8 million, compared to $5.8 million in the same period in 2023. Share-based compensation expenses consisted of $1.4 million for R&D and $4.4 million for SG&A in the fourth quarter of 2024, compared to $1.7 million and $4.1 million, respectively, in the same period in 2023. In terms of Financial Guidance, full year 2024 share-based compensation expenses were $21.4 million which was within our Financial Guidance of $18 million to $22 million. Net Loss and Non-GAAP Net Income (Loss) from Operations 6: Net loss was $15.5 million in the fourth quarter of 2024 compared to $8.5 million in the same period in 2023, and non-GAAP net loss was $2.5 million in the fourth quarter 2024 compared to a non-GAAP net income of $1.4 million in the same period in 2023. See the section titled "Non-GAAP Financial Measures" for more information. Cash Position: Cash, cash equivalents and marketable securities totaled $88.4 million as of December 31, 2024. Strategic Review Committee Theravance Biopharma announced on November 12th, 2024, that the Board of Directors had formed a Strategic Review Committee (the "Committee") composed entirely of independent directors to assess all strategic alternatives available to the Company. The Committee is continuing to evaluate a range of alternatives with the objective of unlocking shareholder value. Until this review is complete, we are not in a position to provide additional details on the review process. 2025 Financial Guidance Operating Expenses ( excluding share-based compensation) : The Company expects full year 2025 R&D expense of $32 million to $38 million and SG&A expense of $50 million to $60 million, in each case excluding share-based compensation. Share-Based Compensation: The Company expects full year share-based compensation expense of $18 million to $20 million. Non-GAAP Loss from Operations and Cash Burn6: The Company expects minimal levels of Non-GAAP Losses from Operations and Cash Burn in 2025, similar to levels incurred in 2024. 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 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 , under the Investors section, Presentations and Events. A replay of the webcast will be available on Theravance Biopharma's website for 30 days through March 28, 2025. 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 worsening of 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).7 There are approximately 50,000 MSA patients in the US8 and 70-90% of MSA patients experience nOH symptoms.9 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 . 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, potential, and objectives, future growth of YUPELRI sales, future milestone and royalty payments, the ability to provide value to shareholders, the Company's regulatory strategies and timing of clinical studies, potential or 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 November 14, 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 income (loss) 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 income (loss) to its corresponding measure, net income (loss). A reconciliation of non-GAAP net income (loss) 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 SOURCE Theravance Biopharma, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED