Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Patients Presenting to the Emergency Department With Acute Exacerbation of COPD (ECOPD): A Phase IV, Prospective, Randomized, Blinded, Parallel-group Trial

The primary aim is to determine whether nebulized Formoterol twice daily plus Revefenacin once daily is non-inferior to standard-of-care nebulized Albuterol and Ipratropium therapy four times daily in relieving dyspnea among patients with ECOPD presenting to the ED and requiring hospitalization, as measured by the Modified Borg Dyspnea Scale.
The hypothesize is that patients in the ED for ECOPD, improvement in symptoms, safety, and length of ED or hospital stay after treatment with nebulized Revefenacin and Formoterol will be non-inferior to the Albuterol and Ipratropium combination. The long-acting bronchodilator regimen will provide comparable symptom control with fewer total drug doses compared with standard treatment with short-acting bronchodilators, namely, nebulized Albuterol and Ipratropium. To the best of our knowledge, this will be the first prospective, randomized, double-blind investigation to compare a combination of long-acting nebulized LAMA/LABA bronchodilators with a standard-of-care combination of short-acting nebulized SAMA/SABA bronchodilators in patients with an ECOPD in the ED/hospital setting.

Start Date12 Nov 2026

Sponsor / Collaborator

University of Tennessee

[+1]

CTRI/2025/12/099782

/ Active, not recruitingPhase 3

A open label Randomized Active Controlled Non inferiority Parallel Multicenter Phase III Clinical Trial to Evaluate the Efficacy and Safety of Revefenacin 175 mcg In 3 ml Inhalation Solution Manufactured by BDR Pharmaceuticals International Pvt Ltd India Comparing With Tiotropium Bromide Inhalation Powder Manufactured by Lupin Limited Pithampur M P 454775 India In Patients Receiving Tiotropium Bromide Inhalation Powder for Chronic Obstructive Pulmonary Disease - NIL

Start Date05 Jan 2026

Sponsor / Collaborator

BDR Pharmaceuticals International Pvt Ltd.

NCT07133880

/ RecruitingPhase 4IIT

Differentiating the Effects of Long-acting Bronchodilators Administered by Nebulizer Versus Dry Powder Inhaler in Symptomatic Patients With Chronic Obstructive Pulmonary Disease

The purpose of this study is to compare the effectiveness of inhaled bronchodilators delivered via nebulizers vs. dry powder inhalers (DPIs) in symptomatic participants with Chronic Obstructive Pulmonary Disease (COPD) who have airflow obstruction (FEV1/FVC ≤ 70%) and show significant air trapping (RV ≥ 120% of predicted).
The investigators hypothesize that, in patients with symptomatic COPD, therapy with a long-acting anti muscarinic agent/long-acting beta agonist (LAMA/LABA) combination administered by nebulizer will improve hyperinflation (increase in inspiratory capacity and reduction in residual volume) and reduce symptoms related to COPD to a greater extent than LAMA/LABA therapy given by a DPI.
The study aims to demonstrate the following:
1. Compare the values of inspiratory capacity (IC) and residual volume (RV) in patients receiving LAMA/LABA by DPI with those receiving LAMA/LABA by nebulizer
2. Compare patient reported outcomes (COPD Assessment Test (CAT score), Baseline/Transition Dyspnea Index (BDI/TDI) and the St. George Respiratory Questionnaire (SGRQ) in symptomatic patients with COPD receiving LAMA/LABA by DPI with those receiving LAMA/LABA by nebulizer

Start Date05 Dec 2023

Sponsor / Collaborator

University of Tennessee

[+1]

100 Clinical Results associated with Revefenacin

100 Translational Medicine associated with Revefenacin

100 Patents (Medical) associated with Revefenacin

Literatures (Medical) associated with Revefenacin

01 Sep 2025·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Development of a novel stability-indicating UHPLC method for revefenacin quality control and impurity identification using 2D-LC-HRMS

Article

Author: Xu, Nuo ; Xiao, Chaoqiang ; Guo, Wei ; Sun, Lu ; Zhou, Sunxin ; Zhang, Weifeng ; Zhang, Tong ; He, Shuwang

Revefenacin (Rev) inhalation solution is the only once-daily nebulized bronchodilator approved in the USA for chronic obstructive pulmonary disease treatment. Despite the critical role of quality control in pharmaceutical manufacturing, no established methods exist for Rev, and its degradation pathways remain unreported. This study performed forced degradation to generate impurity-containing samples, which were used to develop a novel ultrahigh-performance liquid chromatography (UHPLC) method. Qualitative analysis of 12 impurities was conducted using two-dimensional liquid chromatography-high-resolution mass spectrometry. Characteristic fragment ions and mass fragmentation processes were examined, leading to the identification and verification of four specific impurities using reference standards. Impurities A (C₂₂H₃₃N₃O₄), B (C₃₅H₄₂N₄O₅), and C (C₁₂H₁₁N) were identified definitively by comparison to reference materials, while DP-9 and DP-11 were tentatively identified based on MS studies. The remaining seven impurities were not identified due to concentrations below the identification threshold. The primary degradation pathways of Rev were oxidation and hydrolysis. The UHPLC method achieved baseline separation of the 12 degradation products (DPs), and its effectiveness was confirmed by assessing sample stability under the proposed chromatographic conditions. The results demonstrate that this method is suitable for Rev quality control. The novel stability-indicating UHPLC method developed for quantifying Rev DPs offers a reliable approach for quality assurance.

08 Aug 2025·Cureus Journal of Medical Science

Stepwise Management of Status Asthmaticus Refractory to Initial Therapy: A Case Report

Article

Author: Singh, Sumi ; Chowdhury, Shafayath ; Shen, Kevin ; Weissman, Brandon

Asthma is one of the most prevalent chronic respiratory illnesses, significantly impacting patients through shortness of breath and even death. Acute exacerbations are usually controlled with a short-acting beta agonist, such as an albuterol inhaler, as well as long-acting agents to prevent the occurrence of exacerbations and status asthmaticus. Status asthmaticus is an emergent episode of asthma that is refractory to standard treatment. This disease presents as tachycardia, tachypnea, and dyspnea. The forced expiratory volume measures the severity of asthma in one second and the serial peak expiratory flow rate. Proper treatment is vital for patient survival. This case report reviews the proper treatment of a patient in her mid-30s presenting to the emergency department due to an asthmatic attack refractory to albuterol. The patient went through a five-stage treatment plan. First, the patient was treated with inhaled beta-2 agonist (albuterol) and corticosteroids (prednisone, dexamethasone, and methylprednisolone). The patient did not improve with these treatments and was given the anticholinergic agent ipratropium bromide in an attempt to increase bronchodilation. Nebulized racemic epinephrine was then added to the patient to optimize maximum bronchodilation and vasoconstriction in an attempt to reduce airway edema and inflammation. To reduce ventilator peak airway pressures through sedation and paralytics, rocuronium and cisatracurium (Nimbex) were administered. Ketamine was added as a sedative and bronchodilator. Propofol and midazolam (Versed) were used to sedate the patient for mechanical ventilation. After the acute episode, maintenance therapy included inhaled corticosteroids (budesonide), a long-acting beta-2 agonist (arformoterol), a long-acting muscarinic antagonist (revefenacin), and montelukast (a leukotriene receptor antagonist). This case illustrates the importance of status asthmaticus treatment as a vital, stepwise process that focuses on bronchodilation, maintaining the airway, mechanical ventilation, sedation, and reducing inflammation and paralysis.

01 Aug 2025·JOURNAL OF SEPARATION SCIENCE

Quantification and Aerodynamic Particle Size Distribution of Revefenacin Aerosol With UHPLC‐MS/MS

Article

Author: Yawen Hong ; Li Ping ; Jing Dou ; Wenjie Luo ; Difeng Zhu ; Chao Chen ; Qixiu Li ; Chenxing Yuan ; Xiaoqing Chi

ABSTRACT:

Aerosol inhalation therapy offers significant benefits in treating chronic obstructive pulmonary disease, including rapid onset of action and reduced systemic side effects. Revefenacin, a long‐acting bronchodilator, has demonstrated efficacy in improving lung function and alleviating chronic obstructive pulmonary disease symptoms through aerosol delivery. However, quantitative methods for determining the inhaled concentration of revefenacin aerosol remain limited. This study developed and validated a rapid, robust ultrahigh‐performance liquid chromatography‐tandem mass spectrometry (UHPLC‐MS/MS) method to quantify revefenacin aerosol concentration. The method, with an analysis time of 2 min, exhibited excellent specificity, precision, and a lower limit of quantification of 2 ng/mL. The aerosol extraction recovery averaged 98.5%. The method was successfully applied to assess aerosol concentration and aerodynamic particle size distribution under different sampling conditions. Results showed that after 15 min of nebulization, the average aerosol concentrations collected using syringe aspiration and impactor sampling methods were 0.98 and 0.95 mg/m 3 , respectively, demonstrating consistency between the techniques. Aerodynamic particle size distribution analysis revealed stable particle size distribution with atomization times of 5 and 15 min, yielding mass median aerodynamic diameters of 2.31 and 2.35 µm, fine particle fractions of 76.5% and 76.7%, and geometric standard deviations of 2.44 and 2.41, respectively. These findings indicate that the aerodynamic properties of revefenacin aerosol remain stable over prolonged nebulization. This study establishes a reliable analytical method for revefenacin aerosol quantification and provides valuable insights into its aerodynamic characteristics, supporting its further application in chronic obstructive pulmonary disease treatment.

112

News (Medical) associated with Revefenacin

05 Nov 2026

·www.biospace.com

Viatris Reports Third-Quarter 2026 Financial Results

Delivers Total Revenues of $3.75 Billion, U.S. GAAP Net Loss of $325 Million and Adjusted EBITDA of $1.20 Billion Receives Regulatory Approval for RYZUMVI® for Presbyopia in the U.S. and WAKIX® in Japan Returns Approximately $717 Million of Capital to Shareholders Year to Date, Including Through Share Repurchases Advances Innovative Medicines Strategy with Planned Acquisition of Pacira BioSciences, Expected to Close by the End of November Raises 2026 Financial Guidance Midpoints for All Metrics [1] PITTSBURGH , Nov. 5, 2026 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced its third-quarter 2026 financial results. Executive Commentary "Our third-quarter results reflect strong execution and reinforce our confidence in the growth trajectory of our business," said Scott A. Smith , CEO, Viatris. "Momentum across key areas of our base business, progress in our pipeline and the benefits of our enterprise-wide strategic review continue to strengthen our company. With the recent U.S. launch of Gwyn Lo, approvals of RYZUMVI in the U.S. and WAKIX in Japan, the potential upcoming approval and launch of fast-acting meloxicam and our recently announced agreement to acquire Pacira BioSciences, we are taking important steps to position Viatris for sustained revenue and earnings growth." "We are very pleased with the operational momentum across our higher-margin businesses and continued focus on cost discipline, which led to strong overall third-quarter results," said Paul Campbell , Interim CFO, Chief Accounting Officer & Corporate Controller, Viatris. "Based on this performance and our confidence in the outlook for the rest of the year, we are once again raising the midpoints of our financial guidance ranges across all key metrics. Also, consistent with our disciplined and balanced capital allocation strategy, we continued returning additional value to shareholders in the quarter and expect the Pacira transaction to have minimal impact on our gross leverage ratio upon expected closing by the end of November." [1] Viatris is not providing forward-looking guidance for U.S. GAAP net earnings (loss) or U.S. GAAP diluted EPS (loss) or a quantitative reconciliation of its 2026 adjusted EBITDA or adjusted EPS guidance. U.S. GAAP net cash provided by operating activities for 2026 is estimated to be between $2.025 billion and $2.1 billion, with a midpoint of approximately $2.0625 billion. 2026 financial guidance ranges as provided on November 5, 2026, exclude the impact of any transaction-related and restructuring-related costs (as defined below) and acquired IPR&D for unsigned deals as they cannot be reasonably forecasted. 2026 financial guidance ranges also exclude any contribution from the planned acquisition of Pacira BioSciences. Please see "2026 Financial Guidance" and "Non-GAAP Financial Measures" for additional information. Third-Quarter Results Three Months Ended September 30, (Unaudited; in millions, except %s and per share amounts) 2026 2025 Reported Change Operational Change (1) (2) Total Revenues $ 3,749.5 $ 3,759.9 — % — % Total Net Sales $ 3,734.7 $ 3,747.5 — % — % Developed Markets 2,215.9 2,255.6 (2) % (1) % Emerging Markets 529.1 570.4 (7) % (6) % JANZ 287.1 306.3 (6) % (5) % Greater China 702.6 615.2 14 % 10 % Net Sales by Product Category Brands $ 2,461.4 $ 2,436.8 1 % 1 % Generics 1,273.3 1,310.7 (3) % (3) % U.S. GAAP Gross Profit $ 1,438.0 $ 1,371.5 5 % U.S. GAAP Gross Margin 38.4 % 36.5 % Adjusted Gross Profit (2) $ 2,176.0 $ 2,104.4 3 % Adjusted Gross Margin (2) 58.0 % 56.0 % U.S. GAAP Net Loss $ (325.3) $ (128.2) NM U.S. GAAP Loss Per Share $ (0.28) $ (0.11) NM Adjusted Net Earnings (2) $ 821.4 $ 784.3 5 % Adjusted EPS (2) $ 0.71 $ 0.67 6 % 3 % EBITDA (2) $ 937.5 $ 800.2 17 % Adjusted EBITDA (2) $ 1,195.7 $ 1,154.6 4 % 1 % U.S. GAAP Net Cash Provided by Operating Activities $ 899.4 $ 744.9 21 % Capital Expenditures 85.7 86.8 (1) % Free Cash Flow (2)(3) $ 813.7 $ 658.1 24 % ___________ (1) See "Certain Key Terms and Presentation Matters" in this release for more information. (2) Non-GAAP financial measures. See "Non-GAAP Financial Measures" for additional information. (3) Excluding the impact of transaction-related and restructuring-related costs of $81 million, free cash flow for the three months ended September 30, 2026, was $895 million. Excluding the impact of transaction-related costs of $70 million, free cash flow for the three months ended September 30, 2025, was $728 million. Nine Months Ended September 30, (Unaudited; in millions, except %s and per share amounts) 2026 2025 Reported Change Operational Change (1) (2) Total Revenues $ 11,023.3 $ 10,596.3 4 % 2 % Total Net Sales $ 10,990.3 $ 10,559.7 4 % 2 % Developed Markets 6,430.4 6,266.6 3 % 1 % Emerging Markets 1,606.8 1,645.4 (2) % (3) % JANZ 856.6 888.1 (4) % (2) % Greater China 2,096.5 1,759.6 19 % 15 % Net Sales by Product Category Brands $ 7,212.3 $ 6,838.2 5 % 3 % Generics 3,778.0 3,721.5 2 % — % U.S. GAAP Gross Profit $ 4,051.7 $ 3,865.6 5 % U.S. GAAP Gross Margin 36.8 % 36.5 % Adjusted Gross Profit (2) $ 6,305.2 $ 5,952.4 6 % Adjusted Gross Margin (2) 57.2 % 56.2 % U.S. GAAP Net Loss (3) $ (267.7) $ (3,174.8) NM U.S. GAAP Loss Per Share (3) $ (0.23) $ (2.70) NM Adjusted Net Earnings (2) $ 2,324.0 $ 2,110.6 10 % Adjusted EPS (2) $ 1.99 $ 1.78 12 % 8 % EBITDA (2) $ 2,215.4 $ (938.8) NM Adjusted EBITDA (2) $ 3,433.5 $ 3,156.9 9 % 6 % U.S. GAAP Net Cash Provided by Operating Activities $ 1,669.5 $ 1,500.1 11 % Capital Expenditures 178.4 182.3 (2) % Free Cash Flow (2)(4) $ 1,491.1 $ 1,317.8 13 % ___________ (1) See "Certain Key Terms and Presentation Matters" in this release for more information. (2) Non-GAAP financial measures. See "Non-GAAP Financial Measures" for additional information. (3) For the nine months ended September 30, 2025, includes the previously disclosed goodwill impairment charge of $2.9 billion as a result of the interim goodwill impairment test performed as of March 31, 2025. (4) Excluding the impact of transaction-related and restructuring-related costs of $312 million, free cash flow for the nine months ended September 30, 2026, was $1.8 billion. Excluding the impact of transaction-related costs of $186 million, free cash flow for the nine months ended September 30, 2025, was $1.5 billion. Financial Highlights for the Third Quarter of 2026 Total revenues were $3.75 billion, essentially flat on both a reported and operational basis compared to third-quarter 2025 results, as new product sales, primarily in Developed Markets, the strength of the North American business, and strong net sales in Greater China largely offset the impact of continued supply constraints in Europe and Emerging Markets and additional competition on certain products. Brands net sales reflect continued strength in Greater China and Emerging Markets. Generics net sales reflect contributions from new product launches and growth in certain products in North America, more than offset by continued supply constraints in Europe and Emerging Markets. The Company generated approximately $115 million in new product revenues (approximately $287 million for the year) and now expects to deliver approximately $450 million in new product revenues in full-year 2026. U.S. GAAP net loss was $325 million compared to U.S. GAAP net loss of $128 million in the third quarter of 2025 and U.S. GAAP diluted loss per share was $(0.28) compared to a loss of $(0.11) per share in the third quarter of 2025. The loss in the third quarter of 2026 was primarily driven by an increase in income tax provision due to losses in jurisdictions for which minimal benefit can be realized. Adjusted EBITDA was $1.20 billion, up 4% on a reported basis and up 1% on an operational basis compared to the third quarter of 2025, and adjusted EPS was $0.71 per share, up 6% on a reported basis and up 3% on an operational basis compared to the third quarter of 2025. The Company generated U.S. GAAP net cash provided by operating activities of $899 million ($1.67 billion for the year) and free cash flow, excluding the impact of transaction-related and restructuring-related costs, of $895 million ($1.80 billion for the year). Additional Highlights In October, the Company launched Gwyn Lo™ (norelgestromin and ethinyl estradiol transdermal system) in the U.S. Gwyn Lo is a combined hormonal contraceptive (CHC) patch indicated for the prevention of pregnancy in women with a BMI < 30 kg/m2. Approved by the U.S. Food and Drug Administration (FDA) in July, Gwyn Lo is designed to provide a low-dose estrogen, non-daily contraceptive option for appropriate patients. In October, the Company announced that the FDA approved RYZUMVI ® (phentolamine ophthalmic solution 0.75%) for the treatment of presbyopia in adults. RYZUMVI was previously approved in the U.S. for the treatment of pharmacologically induced mydriasis and is the only commercially available FDA-approved product for that use. This approval expands the product's indications to include presbyopia. In October, the Company and Pacira BioSciences, Inc. (Nasdaq: PCRX), a leader in innovative non-opioid pain therapies, announced that they entered into a definitive agreement under which Viatris has agreed to acquire all of the outstanding shares of common stock of Pacira for $36.50 per share in cash, representing an aggregate equity value of $1.65 billion. The transaction is expected to close by the end of November 2026. In September, the Company announced that Japan's Ministry of Health, Labour and Welfare granted approval for WAKIX® (pitolisant) for the treatment of excessive daytime sleepiness (EDS) associated with obstructive sleep apnea syndrome (OSAS) in patients receiving treatment for airway obstruction, and approval for narcolepsy (type 1 and 2 – with and without cataplexy). In September, the Company received notice from the FDA that the inspection classification of Company's oral solid dose manufacturing facility in Nashik, India was Official Action Indicated, following the issuance of 483 observations in May. In October, out of an abundance of caution, the Company voluntarily suspended manufacturing at the facility to focus on remediation activities. The Company expects to resume production at the facility during the first quarter of 2027. The Company estimates the total revenue impact of supply constraints was approximately $100 million in the third quarter of 2026 and currently anticipates an impact of approximately $100 million to total revenues in the fourth quarter of 2026. Capital Allocation Through September 30, 2026, the Company has returned approximately $717 million of capital to shareholders, including approximately $300 million through share repurchases. The Company has approximately $700 million remaining under its existing board-authorized share repurchase program, providing continued flexibility to return additional capital to shareholders. 2026 Financial Guidance Viatris is raising the midpoints of its 2026 financial guidance ranges, each as set forth below. The Company is not providing forward-looking guidance for U.S. GAAP net earnings (loss) or U.S. GAAP diluted earnings (loss) per share (EPS) or a quantitative reconciliation of its 2026 adjusted EBITDA or adjusted EPS guidance to the most directly comparable U.S. GAAP measures, U.S. GAAP net earnings (loss) or U.S. GAAP diluted EPS, respectively, because it is unable to predict with reasonable certainty the ultimate outcome of certain significant items, including integration, acquisition and divestiture-related expenses, restructuring expenses, asset impairments, litigation settlements, future share repurchases, and other contingencies, such as changes to contingent consideration, acquired IPR&D and certain other gains or losses as well as related income tax accounting, because certain of these items have not occurred, are out of the Company's control and/or cannot be reasonably predicted without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on U.S. GAAP reported results for the guidance period. With respect to the Estimated Ranges as provided on November 5, 2026, U.S. GAAP net cash provided by operating activities for 2026 is estimated to be between $2.025 billion and $2.1 billion, with a midpoint of approximately $2.0625 billion. With respect to the Estimated Ranges as provided on August 6, 2026, U.S. GAAP net cash provided by operating activities for 2026 was estimated to be between $1.9 billion and $2.1 billion, with a midpoint of approximately $2.0 billion. (In millions, except Adjusted EPS) Estimated Ranges (2) August 6, 2026 Midpoint (2) August 6, 2026 Estimated Ranges (3) November 5, 2026 Midpoint (3) November 5, 2026 Total Revenues $14,550 - $14,950 $14,750 $14,700 - $14,900 $14,800 Adjusted EBITDA (1) $4,300 - $4,500 $4,400 $4,450 - $4,550 $4,500 Adjusted EPS (1) $2.45 - $2.59 $2.52 $2.56 - $2.63 $2.60 Free Cash Flow (1) Excluding Transaction-related and Restructuring-related Costs $2,050 - $2,350 $2,200 $2,225 - $2,375 $2,300 (1) Non-GAAP financial measures. See "Non-GAAP Financial Measures" for additional information. (2) 2026 Financial Guidance as provided on August 6, 2026, excluded any acquired IPR&D for unsigned deals to be incurred in any future period as it could not be reasonably forecasted. (3) 2026 Financial Guidance as provided on November 5, 2026, excludes any acquired IPR&D for unsigned deals to be incurred in any future period as it cannot be reasonably forecasted. Also excludes any contribution from the proposed acquisition of Pacira BioSciences. Conference Call and Earnings Materials As previously announced, Viatris will host a conference call and live webcast, today at 8:30 a.m. ET, to review the Company's third-quarter 2026 financial results and the planned acquisition of Pacira BioSciences. Investors and the general public are invited to listen to a live webcast of the call at investor.viatris.com or by calling 844.308.3344 or 412.317.1896 for international callers. The "Viatris Q3 2026 Earnings Presentation," which will be referenced during the call, can be found at investor.viatris.com . A replay of the webcast also will be available on the website. About Viatris Viatris Inc . (Nasdaq: VTRS) is a global healthcare company whose mission is to empower people worldwide to live healthier at every stage of life. We meet the needs of patients around the world by acting decisively with ingenuity and resolve. Whether we're developing new medicines, working to maintain a resilient supply of needed therapies, or pursuing bold innovation, we strive to deliver solutions that are effective at scale and built to endure. We're purpose-built to make an impact with a broad portfolio that spans generics, value-added medicines, established brands and innovative medicines that address areas of significant unmet need. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at viatris.com and investor.viatris.com , and connect with us on LinkedIn , Instagram , YouTube and X . Non-GAAP Financial Measures This press release includes the presentation and discussion of certain financial information that differs from what is reported under accounting principles generally accepted in the United States ("U.S. GAAP"). These non-GAAP financial measures, including, but not limited to, adjusted gross profit, adjusted gross margins, adjusted net earnings, adjusted EPS, EBITDA, adjusted EBITDA, free cash flow, free cash flow excluding the impact of transaction-related and restructuring-related costs, adjusted R&D and as a % of total revenues, adjusted SG&A and as a % of total revenues, adjusted earnings from operations, adjusted interest expense, adjusted other income, net, adjusted effective tax rate, constant currency total revenues, constant currency net sales, constant currency adjusted EBITDA, constant currency adjusted EPS, notional debt, gross leverage ratio and long-term gross leverage ratio target, are presented in order to supplement investors' and other readers' understanding and assessment of the financial performance of Viatris Inc. ("Viatris" or the "Company"). Free cash flow refers to U.S. GAAP net cash provided by operating activities less capital expenditures. Management uses these measures internally for forecasting, budgeting, measuring its operating performance, and incentive-based awards. Primarily due to acquisitions, divestitures and other significant events which may impact comparability of our periodic operating results, Viatris believes that an evaluation of its ongoing operations (and comparisons of its current operations with historical and future operations) would be difficult if the disclosure of its financial results was limited to financial measures prepared only in accordance with U.S. GAAP. We believe that non-GAAP financial measures are useful supplemental information for our investors and when considered together with our U.S. GAAP financial measures and the reconciliation to the most directly comparable U.S. GAAP financial measure, provide a more complete understanding of the factors and trends affecting our operations. The financial performance of the Company is measured by senior management, in part, using adjusted metrics included herein, along with other performance metrics. In addition, the Company believes that including EBITDA and supplemental adjustments applied in presenting adjusted EBITDA is appropriate to provide additional information to investors to demonstrate the Company's ability to comply with financial debt covenants and assess the Company's ability to incur additional indebtedness. The Company also believes that adjusted EBITDA better focuses management on the Company's underlying operational results and true business performance and is used, in part, for management's incentive compensation. We also report sales performance using the non-GAAP financial measures of "constant currency", also referred to herein as "operational change", total revenues, net sales, adjusted EBITDA, and adjusted EPS. These measures provide information on the change in total revenues, net sales, adjusted EBITDA, and adjusted EPS assuming that foreign currency exchange rates had not changed between the prior and current period. The comparisons presented at constant currency rates reflect comparative local currency sales at the prior year's foreign exchange rates. We routinely evaluate our net sales, total revenues, adjusted EBITDA, and adjusted EPS performance at constant currency so that sales results can be viewed without the impact of foreign currency exchange rates, thereby facilitating a period-to-period comparison of our operational activities and believe that this presentation also provides useful information to investors for the same reason. The "Summary of Total Revenues by Segment" table below compares total revenues and net sales on an actual and constant currency basis for each reportable segment for the three and nine months ended September 30, 2026 and 2025. Also, set forth below, Viatris has provided reconciliations of such non-GAAP financial measures to the most directly comparable U.S. GAAP financial measures. Investors and other readers are encouraged to review the related U.S. GAAP financial measures and the reconciliations of the non-GAAP measures to their most directly comparable U.S. GAAP measures set forth below, and investors and other readers should consider non-GAAP measures only as supplements to, not as substitutes for or as superior measures to, the measures of financial performance prepared in accordance with U.S. GAAP. For additional information regarding the components and uses of non-GAAP financial measures refer to Management's Discussion and Analysis of Financial Condition and Results of Operations--Use of Non-GAAP Financial Measures section of Viatris' Quarterly Report on Form 10-Q for the three and nine months ended September 30, 2026. With respect to the guidance ranges as provided on August 6, 2026, at that time the Company did not provide forward-looking guidance for U.S. GAAP net earnings (loss) or U.S. GAAP diluted EPS or a quantitative reconciliation of its 2026 adjusted EBITDA or adjusted EPS guidance to the most directly comparable U.S. GAAP measures, U.S. GAAP net earnings (loss) or U.S. GAAP diluted EPS, respectively, because it was unable to predict with reasonable certainty the ultimate outcome of certain significant items, including integration, acquisition and divestiture-related expenses, restructuring expenses, asset impairments, litigation settlements, future share repurchases, and other contingencies, such as changes to contingent consideration, acquired IPR&D and certain other gains or losses, as well as related income tax accounting, because certain of these items had not occurred, were out of the Company's control, and/or could not be reasonably predicted without unreasonable effort. These items were uncertain, depended on various factors, and could have had a material impact on U.S. GAAP reported results for the guidance period. As previously disclosed, such guidance ranges excluded the impact of transaction-related and restructuring-related costs as well as any acquired IPR&D for unsigned deals to be incurred in any future period as it could not be reasonably forecasted. With respect to the Estimated Ranges as provided on August 6, 2026, U.S. GAAP net cash provided by operating activities for 2026 was estimated to be between $1.9 billion and $2.1 billion, with a midpoint of approximately $2.0 billion. Certain Key Terms and Presentation Matters New product sales, new product launches or new product revenues: Refers to revenue from new products launched in 2026 and the carryover impact of new products, including business development, launched within the last 12 months. Operational change: Refers to constant currency percentage changes and is derived by translating amounts for the current period at prior year comparative period exchange rates and in doing so shows the percentage change from 2026 constant currency net sales, total revenues, adjusted EBITDA, and adjusted EPS to the corresponding amount in the prior year. Transaction-related costs: Refers to the impact of any acquisition and divestiture-related transaction costs, including taxes. Restructuring-related costs: Refers to the impact of any cash costs associated with the restructuring activities of the enterprise-wide strategic review, which are expected to be primarily related to severance and employee benefits expense, as well as other costs, including those related to contract terminations, vendor consolidations, product transfer costs and network related simplification and modernization costs. Revenue and Earnings : Refers to Total Revenues, Adjusted EBITDA and Adjusted EPS. Forward-Looking Statements This press release contains "forward-looking statements". These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include, without limitation, statements about our 2026 financial guidance; advances innovative medicines strategy with planned acquisition of Pacira BioSciences, expected to close by the end of November; our third-quarter results reflect strong execution and reinforce our confidence in the growth trajectory of our business' momentum across key areas of our base business, progress in our pipeline and the benefits of our enterprise-wide strategic review continue to strengthen our company; with the recent U.S. launch of Gwyn Lo, approvals of RYZUMVI in the U.S. and WAKIX in Japan, the potential upcoming approval and launch of fast-acting meloxicam and our recently announced agreement to acquire Pacira BioSciences, we are taking important steps to position Viatris for sustained revenue and earnings growth; we are very pleased with the operational momentum across our higher-margin businesses and continued focus on cost discipline, which led to strong overall third-quarter results; based on this performance and our confidence in the outlook for the rest of the year, we are once again raising the midpoints of our financial guidance ranges across all key metrics; consistent with our disciplined and balanced capital allocation strategy, we continued returning additional value to shareholders in the quarter and expect the Pacira transaction to have minimal impact on our gross leverage ratio upon expected closing by the end of November; now expects to deliver approximately $450 million in new product revenues in full-year 2026; the Company expects to resume production at the facility during the first quarter of 2027; the Company estimates the total revenue impact of supply constraints was approximately $100 million in the third quarter of 2026 and currently anticipates an impact of approximately $100 million to total revenues in the fourth quarter of 2026; the Company has approximately $700 million remaining under its existing board-authorized share repurchase program, providing continued flexibility to return additional capital to shareholders; the goals or outlooks with respect to the Company's strategic initiatives and priorities, including but not limited to divestitures, acquisitions, strategic alliances, collaborations, or other potential transactions; the anticipated benefits of such strategic initiatives or priorities or restructuring activities; future opportunities for the Company and its products; the outcomes of clinical trials and research studies; R&D and new product development; and any other statements regarding the Company's future operations, financial or operating results, capital allocation, dividend policy and payments, share repurchases, debt ratio and covenants, anticipated business levels, future earnings, planned activities, anticipated growth, market opportunities, strategies, imperatives, competitions, commitments, confidence in future results, efforts to create, enhance or otherwise unlock value, and other expectations and targets for future periods. Forward-looking statements may often be identified by the use of words such as "will", "may", "could", "should", "would", "project", "believe", "anticipate", "expect", "plan", "estimate", "forecast", "potential", "pipeline", "intend", "continue", "target", "seek" and variations of these words or comparable words. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the possibility that the Company may not realize the intended benefits of, or achieve the intended goals or outlooks with respect to, its strategic initiatives and priorities; the possibility that the Company may be unable to achieve the intended or expected benefits of its enterprise-wide strategic review and related cost-saving and restructuring activities within the expected timeframe or at all; the possibility that the Company may be unable to achieve intended or expected benefits in connection with divestitures, acquisitions, strategic alliances, collaborations, or other transactions, or restructuring programs, within the expected timeframes or at all; the possibility that the Company may not complete the proposed acquisition of Pacira within the timeframe it anticipates or at all and, if completed, the possibility that the Company may not realize the anticipated benefits, synergies and operating efficiencies of the proposed acquisition; goodwill or impairment charges or other losses; success of clinical trials and the Company's or its partners' ability to execute on new product opportunities and develop, manufacture and commercialize products; any changes in or difficulties with the Company's manufacturing facilities, including with respect to short- or long-term shutdowns, inspections, remediation and restructuring activities, supply chain continuity, inventory management, or the ability to meet anticipated demand; the Company's failure to achieve expected or targeted future financial and operating performance and results; the potential impact of natural or man-made disasters, public health outbreaks, fires, accidents, weather, unrest or other emergencies in regions where we or our partners or suppliers operate; actions and decisions of healthcare and pharmaceutical regulators; changes in relevant laws, regulations and policies and/or the application or implementation thereof, including but not limited to tax, healthcare and pharmaceutical laws, regulations and policies globally; the ability to attract, motivate and retain key personnel; the Company's liquidity, capital resources and ability to obtain financing; any regulatory, legal or other impediments to the Company's ability to bring new products to market; products in development that receive regulatory approval may not achieve expected levels of market acceptance, efficacy or safety; longer review, response and approval times as a result of evolving regulatory priorities and reductions in personnel at health agencies; the scope, timing and outcome of any ongoing legal proceedings, including government inquiries or investigations, and the impact of any such proceedings on the Company; any significant breach of data security or data privacy or disruptions to our IT systems; risks associated with having significant operations globally; the ability to protect intellectual property and preserve intellectual property rights; changes in third-party relationships; the effect of any changes in the Company's or its partners' customer and supplier relationships and customer purchasing patterns, including customer loss and business disruption being greater than expected following an adverse regulatory action, acquisition or divestiture; the impacts of competition, including decreases in sales or revenues as a result of the loss of market exclusivity for certain products; changes in the economic and financial conditions of the Company or its partners; uncertainties regarding future demand, pricing and reimbursement for the Company's products; uncertainties and matters beyond the control of management, including but not limited to general political and economic conditions, wars or other conflicts, potential for adverse impacts from future tariffs and trade restrictions, inflation rates and global exchange rates; and inherent uncertainties involved in the estimates and judgments used in the preparation of financial statements, and the providing of estimates of financial measures, in accordance with U.S. GAAP and related standards or on an adjusted basis. For more detailed information on the risks and uncertainties associated with Viatris, see the risks described in Part I, Item 1A of the Company's Annual Report on Form 10-K for the year ended December 31, 2025, Part II, Item 1A of the Company's Quarterly Report on Form 10-Q for the three months ended September 30, 2026, and our other filings with the SEC. You can access Viatris' filings with the SEC through the SEC website at or through our website, and Viatris strongly encourages you to do so. Viatris routinely posts information that may be important to investors on our website at investor.viatris.com, and we use this website address as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). The contents of our website are not incorporated into this press release or our filings with the SEC. Viatris undertakes no obligation to update any statements herein for revisions or changes after the date of this press release other than as required by law. Viatris Inc. and Subsidiaries Condensed Consolidated Statements of Operations (Unaudited) Three Months Ended Nine Months Ended September 30, September 30, (In millions, except per share amounts) 2026 2025 2026 2025 Revenues: Net sales $ 3,734.7 $ 3,747.5 $ 10,990.3 $ 10,559.7 Other revenues 14.8 12.4 33.0 36.6 Total revenues 3,749.5 3,759.9 11,023.3 10,596.3 Cost of sales 2,311.5 2,388.4 6,971.6 6,730.7 Gross profit 1,438.0 1,371.5 4,051.7 3,865.6 Operating expenses: Research and development 231.7 250.4 728.6 691.2 Acquired IPR&D 5.0 — 5.2 10.0 Selling, general and administrative 950.8 886.6 3,014.1 2,763.4 Impairment of goodwill — — — 2,936.8 Litigation settlements and other contingencies, net (11.0) 55.7 115.7 (65.4) Total operating expenses 1,176.5 1,192.7 3,863.6 6,336.0 Earnings (loss) from operations 261.5 178.8 188.1 (2,470.4) Interest expense 112.4 119.6 353.2 351.7 Other expense, net 21.2 67.1 18.3 499.9 Earnings (loss) before income taxes 127.9 (7.9) (183.4) (3,322.0) Income tax provision (benefit) 453.2 120.3 84.3 (147.2) Net loss $ (325.3) $ (128.2) $ (267.7) $ (3,174.8) Loss per share attributable to Viatris Inc. shareholders Basic $ (0.28) $ (0.11) $ (0.23) $ (2.70) Diluted $ (0.28) $ (0.11) $ (0.23) $ (2.70) Weighted average shares outstanding: Basic 1,148.6 1,164.6 1,155.8 1,176.7 Diluted 1,148.6 1,164.6 1,155.8 1,176.7 Viatris Inc. and Subsidiaries Condensed Consolidated Balance Sheets (Unaudited) (In millions) September 30, 2026 December 31, 2025 ASSETS Assets Current assets: Cash and cash equivalents $ 1,789.2 $ 1,322.4 Accounts receivable, net 3,121.2 3,031.3 Inventories 3,829.2 3,999.2 Prepaid expenses and other current assets 1,558.2 1,436.3 Total current assets 10,297.8 9,789.2 Intangible assets, net 13,079.5 15,102.1 Goodwill 6,620.0 6,754.7 Other non-current assets 4,685.3 5,547.1 Total assets $ 34,682.6 $ 37,193.1 LIABILITIES AND EQUITY Liabilities Current portion of long-term debt and other long-term obligations $ 1,727.5 $ 1,933.3 Other current liabilities 4,909.0 5,161.0 Long-term debt 11,587.5 12,480.6 Other non-current liabilities 2,773.1 2,906.9 Total liabilities 20,997.1 22,481.8 Shareholders' equity 13,685.5 14,711.3 Total liabilities and equity $ 34,682.6 $ 37,193.1 Viatris Inc. and Subsidiaries Key Product Net Sales, on a Consolidated Basis (Unaudited) Three months ended September 30, Nine months ended September 30, (In millions) 2026 2025 2026 2025 Select Key Global Products Lipitor ® $ 451.9 $ 396.1 $ 1,366.1 $ 1,172.0 Norvasc ® 190.2 179.7 600.4 534.7 EpiPen® Auto-Injectors 155.8 157.2 386.1 390.7 Lyrica ® 114.2 126.5 355.4 367.2 Creon ® 98.1 93.1 292.9 266.9 Viagra ® 94.1 105.2 302.0 304.0 Zoloft ® 78.8 66.8 222.8 188.1 Celebrex ® 70.2 73.3 213.7 206.7 Effexor ® 63.9 67.2 192.6 189.6 Xalabrands 43.9 38.6 121.9 116.4 Select Key Segment Products Influvac ® $ 90.6 $ 125.4 $ 100.5 $ 130.8 Yupelri ® 71.5 71.4 204.7 196.3 Xanax ® 36.6 34.2 109.5 100.4 Amitiza ® 36.4 40.8 109.8 115.7 Dymista ® 35.4 33.8 112.5 125.0 ____________ (a) The Company does not disclose net sales for any products considered competitively sensitive. (b) Products disclosed may change in future periods, including as a result of seasonality, competition or new product launches. (c) Amounts include the impact of foreign currency fluctuations compared to the prior year period. Viatris Inc. and Subsidiaries Reconciliation of Non-GAAP Financial Measures (Unaudited) Reconciliation of U.S. GAAP Net Loss to Adjusted Net Earnings and U.S. GAAP Loss Per Share to Adjusted EPS Below is a reconciliation of U.S. GAAP net loss and diluted loss per share to adjusted net earnings and adjusted EPS for the three and nine months ended September 30, 2026, compared to the prior year period: Three Months Ended September 30, Nine Months Ended September 30, (In millions, except per share amounts) 2026 2025 2026 2025 U.S. GAAP net loss and U.S. GAAP diluted loss per share $ (325.3) $ (0.28) $ (128.2) $ (0.11) $ (267.7) $ (0.23) $ (3,174.8) $ (2.70) Purchase accounting amortization (primarily included in cost of sales) 613.7 605.8 1,791.6 1,787.1 Impairment of goodwill — — — 2,936.8 Litigation settlements and other contingencies, net (11.0) 55.7 115.7 (65.4) Interest expense (primarily amortization of premiums and discounts on long term debt) (10.6) (9.9) (30.9) (28.6) (Gain) / loss on divestitures of businesses (included in other expense, net) — (1.6) 13.9 79.1 Acquisition and divestiture-related costs (primarily included in cost of sales and SG&A) (a) 44.5 40.0 158.2 134.4 Restructuring costs (b) 66.2 17.2 206.5 136.7 Share-based compensation expense 39.6 36.0 126.5 128.3 Other special items included in: Cost of sales (c) 65.8 89.4 264.5 190.1 Research and development expense 1.7 5.6 5.6 7.7 Selling, general and administrative expense (d) 37.2 18.0 313.7 65.7 Other expense, net (e) 26.8 102.4 52.3 508.4 Tax effect of the above items and other income tax related items (f) 272.8 (46.1) (425.9) (594.9) Adjusted net earnings and adjusted EPS $ 821.4 $ 0.71 $ 784.3 $ 0.67 $ 2,324.0 $ 1.99 $ 2,110.6 $ 1.78 Weighted average diluted shares outstanding 1,160.6 1,172.2 1,169.4 1,184.0 ____________ Significant items include the following: (a) Acquisition and divestiture-related costs consist primarily of contractual obligations related to divestitures, transaction costs including legal and consulting fees, and integration activities. (b) For the three and nine months ended September 30, 2026, charges include approximately $19.1 million and $95.8 million, respectively, in cost of sales, approximately $0.8 million and $3.4 million, respectively, in R&D, and approximately $46.3 million and $107.3 million, respectively, in SG&A, primarily relating to the 2026 restructuring program. (c) For the three and nine months ended September 30, 2026, includes certain asset impairments, contractual termination costs, and incremental manufacturing variances and certain remediation costs at plants slated for sale or closure or undergoing remediation activities of approximately $52.4 million and $227.3 million, respectively, including charges of $11.8 million and $98.6 million, respectively, primarily related to the write off of inventory and fixed assets damaged in the fire at the Nashik manufacturing facility and incremental manufacturing variances. (d) For the three and nine months ended September 30, 2026, includes a (gain)/loss of $(0.8) million and $177.0 million, respectively, related to the sale of the product rights for Tyrvaya®. (e) For the three and nine months ended September 30, 2026, charges include a pre-tax loss of approximately $27.4 million and $36.0 million, respectively, as a result of changes in the fair value and subsequent sale of the Biocon Limited equity shares. (f) Adjusted for changes for uncertain tax positions. Reconciliation of U.S. GAAP Net Loss to EBITDA and Adjusted EBITDA Below is a reconciliation of U.S. GAAP net loss to EBITDA and adjusted EBITDA for the three and nine months ended September 30, 2026, compared to the prior year period: Three Months Ended Nine Months Ended September 30, September 30, (In millions) 2026 2025 2026 2025 U.S. GAAP net loss $ (325.3) $ (128.2) $ (267.7) $ (3,174.8) Add / (deduct) adjustments: Income tax provision (benefit) 453.2 120.3 84.3 (147.2) Interest expense (a) 112.4 119.6 353.2 351.7 Depreciation and amortization (b) 697.2 688.5 2,045.6 2,031.5 EBITDA $ 937.5 $ 800.2 $ 2,215.4 $ (938.8) Add / (deduct) adjustments: Share-based compensation expense 39.6 36.0 126.5 128.3 Litigation settlements and other contingencies, net (11.0) 55.7 115.7 (65.4) (Gain) / loss on divestitures of businesses — (1.6) 13.9 79.1 Impairment of goodwill — — — 2,936.8 Restructuring, acquisition and divestiture-related and other special items (c) 229.6 264.3 962.0 1,016.9 Adjusted EBITDA $ 1,195.7 $ 1,154.6 $ 3,433.5 $ 3,156.9 ____________ (a) Includes amortization of premiums and discounts on long-term debt. (b) Includes purchase accounting related amortization. (c) See items detailed in the Reconciliation of U.S. GAAP Net Loss to Adjusted Net Earnings. Summary of Total Revenues by Segment Three Months Ended September 30, (In millions, except %s) 2026 2025 % Change 2026 Currency Impact (1) 2026 Constant Currency Revenues Constant Currency % Change (2) Net sales Developed Markets $ 2,215.9 $ 2,255.6 (2) % $ 16.3 $ 2,232.2 (1) % Greater China 702.6 615.2 14 % (26.3) 676.3 10 % JANZ 287.1 306.3 (6) % 5.0 292.1 (5) % Emerging Markets 529.1 570.4 (7) % 6.9 536.0 (6) % Total net sales $ 3,734.7 $ 3,747.5 — % $ 1.9 $ 3,736.6 — % Other revenues (3) 14.8 12.4 NM 0.3 15.1 NM Consolidated total revenues (4) $ 3,749.5 $ 3,759.9 — % $ 2.2 $ 3,751.7 — % Nine Months Ended September 30, (In millions, except %s) 2026 2025 % Change 2026 Currency Impact (1) 2026 Constant Currency Revenues Constant Currency % Change (2) Net sales Developed Markets $ 6,430.4 $ 6,266.6 3 % $ (132.3) $ 6,298.1 1 % Greater China 2,096.5 1,759.6 19 % (80.5) 2,016.0 15 % JANZ 856.6 888.1 (4) % 9.3 865.9 (2) % Emerging Markets 1,606.8 1,645.4 (2) % (5.6) 1,601.2 (3) % Total net sales $ 10,990.3 $ 10,559.7 4 % $ (209.1) $ 10,781.2 2 % Other revenues (3) 33.0 36.6 NM 0.1 33.1 NM Consolidated total revenues (4) $ 11,023.3 $ 10,596.3 4 % $ (209.0) $ 10,814.3 2 % ____________ (1) Currency impact is shown as unfavorable (favorable). (2) The constant currency percentage change is derived by translating net sales or revenues for the current period at prior year comparative period exchange rates, and in doing so shows the percentage change from 2026 constant currency net sales or revenues to the corresponding amount in the prior year. (3) For the three months ended September 30, 2026, other revenues in Developed Markets, JANZ, and Emerging Markets were approximately $8.9 million, $3.9 million, and $2.0 million, respectively. For the nine months ended September 30, 2026, other revenues in Developed Markets, JANZ, and Emerging Markets were approximately $23.4 million, $4.1 million, and $5.5 million, respectively. (4) Amounts exclude intersegment revenue which is eliminated on a consolidated basis. Reconciliation of Statements of Operations Line Items (Unaudited) Three Months Ended Nine Months Ended September 30, September 30, (In millions, except %s) 2026 2025 2026 2025 U.S. GAAP cost of sales $ 2,311.5 $ 2,388.4 $ 6,971.6 $ 6,730.7 Deduct: Purchase accounting amortization and other related items (613.7) (605.8) (1,791.6) (1,787.1) Acquisition and divestiture-related costs (38.8) (23.6) (99.2) (62.2) Restructuring costs (19.1) (13.4) (95.8) (44.5) Share-based compensation expense (0.6) (0.7) (2.4) (2.9) Other special items, including restructuring related costs (65.8) (89.4) (264.5) (190.1) Adjusted cost of sales $ 1,573.5 $ 1,655.5 $ 4,718.1 $ 4,643.9 Adjusted gross profit (a) $ 2,176.0 $ 2,104.4 $ 6,305.2 $ 5,952.4 Adjusted gross margin (a) 58 % 56 % 57 % 56 % Three Months Ended Nine Months Ended September 30, September 30, (In millions, except %s) 2026 2025 2026 2025 U.S. GAAP R&D $ 231.7 $ 250.4 $ 728.6 $ 691.2 Deduct: Acquisition and divestiture-related costs (1.3) (5.7) (4.4) (9.0) Restructuring costs (0.8) — (3.4) (2.2) Share-based compensation expense (2.2) (1.4) (7.0) (5.9) Other special items (1.7) (5.6) (5.6) (7.7) Adjusted R&D $ 225.7 $ 237.7 $ 708.2 $ 666.4 Adjusted R&D as % of total revenues 6 % 6 % 6 % 6 % Three Months Ended Nine Months Ended September 30, September 30, (In millions, except %s) 2026 2025 2026 2025 U.S. GAAP SG&A $ 950.8 $ 886.6 $ 3,014.1 $ 2,763.4 Deduct: Acquisition and divestiture-related costs (4.7) (10.6) (54.8) (63.1) Restructuring costs (46.3) (3.7) (107.3) (90.0) Share-based compensation expense (36.8) (33.8) (117.1) (119.4) Other special items and reclassifications (37.2) (18.0) (313.7) (65.7) Adjusted SG&A $ 825.8 $ 820.5 $ 2,421.2 $ 2,425.2 Adjusted SG&A as % of total revenues 22 % 22 % 22 % 23 % Three Months Ended Nine Months Ended September 30, September 30, (In millions) 2026 2025 2026 2025 U.S. GAAP total operating expenses $ 1,176.5 $ 1,192.7 $ 3,863.6 $ 6,336.0 Add / (Deduct): Litigation settlements and other contingencies, net 11.0 (55.7) (115.7) 65.4 R&D adjustments (6.0) (12.7) (20.4) (24.8) SG&A adjustments (125.0) (66.1) (592.9) (338.2) Impairment of goodwill adjustments — — — (2,936.8) Adjusted total operating expenses $ 1,056.5 $ 1,058.2 $ 3,134.6 $ 3,101.6 Adjusted earnings from operations (b) $ 1,119.5 $ 1,046.2 $ 3,170.6 $ 2,850.8 Three Months Ended Nine Months Ended September 30, September 30, (In millions) 2026 2025 2026 2025 U.S. GAAP interest expense $ 112.4 $ 119.6 $ 353.2 $ 351.7 Add / (Deduct): Accretion of contingent consideration liability (0.8) (1.1) (2.6) (3.5) Amortization of premiums and discounts on long-term debt 11.7 11.7 35.2 34.1 Other special items (0.2) (0.7) (1.6) (2.0) Adjusted interest expense $ 123.1 $ 129.5 $ 384.2 $ 380.3 Three Months Ended Nine Months Ended September 30, September 30, (In millions) 2026 2025 2026 2025 U.S. GAAP other expense, net $ 21.2 $ 67.1 $ 18.3 $ 499.9 Add / (Deduct): Fair value adjustments on non-marketable equity investments — (100.0) — (499.8) Fair value adjustments on marketable equity investments (27.4) — (36.0) — Gain (loss) on divestitures of businesses — 1.6 (13.9) (79.1) Other items 0.9 (2.6) (16.1) (8.7) Adjusted other income, net $ (5.3) $ (33.9) $ (47.7) $ (87.7) Three Months Ended Nine Months Ended September 30, September 30, (In millions, except %s) 2026 2025 2026 2025 U.S. GAAP earnings (loss) before income taxes $ 127.9 $ (7.9) $ (183.4) $ (3,322.0) Total pre-tax non-GAAP adjustments 873.8 958.5 3,017.5 5,880.3 Adjusted earnings before income taxes $ 1,001.7 $ 950.6 $ 2,834.1 $ 2,558.3 U.S. GAAP income tax provision (benefit) $ 453.2 $ 120.3 $ 84.3 $ (147.2) Adjusted tax (benefit) expense (272.9) 46.1 425.8 594.9 Adjusted income tax provision $ 180.3 $ 166.4 $ 510.1 $ 447.7 Adjusted effective tax rate 18.0 % 17.5 % 18.0 % 17.5 % ___________ (a) U.S. GAAP gross profit is calculated as total revenues less U.S. GAAP cost of sales. U.S. GAAP gross margin is calculated as U.S. GAAP gross profit divided by total revenues. Adjusted gross profit is calculated as total revenues less adjusted cost of sales. Adjusted gross margin is calculated as adjusted gross profit divided by total revenues. (b) U.S. GAAP earnings from operations is calculated as U.S. GAAP gross profit less U.S. GAAP total operating expenses. Adjusted earnings from operations is calculated as adjusted gross profit less adjusted total operating expenses. Reconciliation of Estimated 2026 U.S. GAAP Net Cash Provided by Operating Activities to Free Cash Flow as of November 5, 2026 (Unaudited) A reconciliation of the estimated 2026 U.S. GAAP Net Cash provided by Operating Activities to Free Cash Flow is presented below: (In millions) Estimated U.S. GAAP Net Cash provided by Operating Activities $2,025 - $2,100 Less: Capital Expenditures $(325) - $(400) Free Cash Flow $1,625 - $1,775 Add: Estimated Transaction-related and Restructuring-related Costs ~$600 Free Cash Flow Excluding Transaction-related and Restructuring-related Costs $2,225 - $2,375 Reconciliation of Estimated 2026 U.S. GAAP Net Cash Provided by Operating Activities to Free Cash Flow as of August 6, 2026 (Unaudited) A reconciliation of the estimated 2026 U.S. GAAP Net Cash provided by Operating Activities to Free Cash Flow is presented below: (In millions) Estimated U.S. GAAP Net Cash provided by Operating Activities $1,900 - $2,100 Less: Capital Expenditures $(350) - $(450) Free Cash Flow $1,450 - $1,750 Add: Estimated Transaction-related and Restructuring-related Costs ~$600 Free Cash Flow Excluding Transaction-related and Restructuring-related Costs $2,050 - $2,350 Gross Leverage Ratio Gross Leverage Ratio is the ratio of Viatris' total debt at notional amounts at September 30, 2026 to the sum of Viatris' adjusted EBITDA for the quarters ended December 31, 2025, March 31, 2026, June 30, 2026 and September 30, 2026. Three Months Ended Twelve Months Ended (In millions, except ratio) December 31, 2025 March 31, 2026 June 30, 2026 September 30, 2026 September 30, 2026 Adjusted EBITDA $ 1,003.1 $ 1,049.5 $ 1,188.3 $ 1,195.7 $ 4,436.6 Reported debt balances: Long-term debt, including current portion 13,312.3 Short-term borrowings and other current obligations — Total 13,312.3 Add / (deduct): Net premiums on various debt issuances (411.9) Deferred financing fees 23.6 Total debt at notional amounts $ 12,924.0 Gross debt to adjusted EBITDA 2.9 x Long-term Gross Leverage Target The stated forward-looking non-GAAP financial measure of long-term gross leverage target range of 2.8x – 3.2x, is based on the ratio of (i) targeted notional gross debt and (ii) targeted Adjusted EBITDA. However, the Company has not quantified future amounts to develop this target but has stated its goal to manage notional gross debt and Adjusted EBITDA over time in order to generally maintain or reach the target. This target does not reflect Company guidance. Reconciliation of U.S. GAAP Net Loss to EBITDA and Adjusted EBITDA – Last Twelve Months Three Months Ended December 31, 2025 March 31, 2026 June 30, 2026 September 30, 2026 U.S. GAAP net (loss) earnings $ (340.1) $ 176.4 $ (118.8) $ (325.3) Add / (deduct) adjustments: Income tax (benefit) provision (2.9) (423.7) 54.8 453.2 Interest expense (a) 119.6 120.1 120.7 112.4 Depreciation and amortization (b) 766.8 676.1 672.3 697.2 EBITDA $ 543.4 $ 548.9 $ 729.0 $ 937.5 Add / (deduct) adjustments: Share-based compensation expense 49.4 48.2 38.7 39.6 Litigation settlements and other contingencies, net (3.1) 53.5 73.2 (11.0) Loss on divestitures of businesses 21.9 13.9 — — Restructuring, acquisition and divestiture-related and other special items 391.5 385.0 347.4 229.6 Adjusted EBITDA $ 1,003.1 $ 1,049.5 $ 1,188.3 $ 1,195.7 ____________ (a) Includes amortization of premiums and discounts on long-term debt. (b) Includes purchase accounting related amortization. View original content to download multimedia: SOURCE Viatris Inc.

Drug ApprovalAcquisitionFinancial Statement

24 Oct 2026

·www.globenewswire.com

Zymeworks Presents New Phase 1 Data for Folate Receptor Alpha-Targeting Antibody-Drug Conjugate ZW191 at ESMO Congress 2026

ZW191 demonstrates compelling anti-tumor activity in heavily pretreated patients with platinum-resistant ovarian cancer across folate receptor alpha (FRα) expression levelsConfirmed objective response rates (cORR) of 64.5% at the 6.4 mg/kg dose in patients with high-grade serous platinum-resistant ovarian cancerMedian duration of response not yet reached at either dose level at median 7 months follow-up, with six-month progression-free survival rate of 61% in both groupsFavorable tolerability profile, particularly at 6.4 mg/kg, supports continued clinical development in partnership or through a strategic collaborationConference call with Zymeworks management on October 27 at 8:30 am Eastern Time (ET) VANCOUVER, British Columbia, Oct. 24, 2026 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a biotechnology company managing a portfolio of licensed healthcare assets while developing a diverse pipeline of novel, multifunctional biotherapeutics, today presented new clinical data from the randomized dose-optimization portion of its ongoing Phase 1 study evaluating ZW191, a FRα-targeting antibody-drug conjugate (ADC), at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain. The presentation highlights compelling anti-tumor activity in heavily pretreated patients with platinum-resistant ovarian cancer (PROC), including patients with high-grade serous disease across all levels of FRα expression. The results demonstrate compelling response rates, durability and a favorable tolerability profile, particularly at the 6.4 mg/kg dose, further supporting the potential of ZW191 to address limitations of currently available FRα-targeted therapies and expand treatment opportunities for patients with ovarian cancer. “We are highly encouraged by these results, which further demonstrate the differentiated clinical profile of ZW191 and its potential to deliver meaningful benefit to patients with platinum-resistant ovarian cancer,” said Sabeen Mekan, M.D., Senior Vice President and Chief Medical Officer, Zymeworks. “The robust response rates observed at both doses, including meaningful activity in patients with low or negative FRα expression, reinforce the potential of ZW191 to benefit a broader patient population. Importantly, the encouraging durability of responses and favorable tolerability profile, particularly at 6.4 mg/kg, provide valuable insights to guide dose selection and the next stage of clinical development.” The analysis included efficacy and safety data from 80 patients with PROC randomized to receive ZW191 at 6.4 mg/kg (n=37) or 9.6 mg/kg (n=43) every three weeks, as of the September 10, 2026 data cutoff date. Patients were heavily pretreated, having received a median of four prior lines of therapy, with 45% receiving five or more prior lines. Median follow-up was seven months. FRα expression was assessed by immunohistochemistry and categorized as low/negative (0%–24%), intermediate (25%–74%) or high (75%–100%) based on the percentage of tumor cells with 2+ or 3+ staining intensity. Key Findings Among response-evaluable patients with high-grade serous PROC, ZW191 demonstrated a cORR of 64.5% at 6.4 mg/kg and 55.3% at 9.6 mg/kg, with disease control rates of 100% and 92.1%, respectively. These findings demonstrate compelling anti-tumor activity at both doses in a heavily pretreated patient population. ZW191 demonstrated meaningful anti-tumor activity across FRα expression in patients with high-grade serous PROC. Confirmed objective response rates were 69.2% in patients with high FRα expression, 50.0% in patients with intermediate FRα expression and 55.0% in patients with low or negative FRα expression. These findings support the potential of ZW191 to show improved efficacy than existing FRα targeted therapies in FRα high population and meaningfully benefit patients with lower expression who may not be eligible for currently approved FRα targeting therapies. Responses to ZW191 were deep and durable, with median duration of response not yet reached at either dose. Six-month progression-free survival (PFS) was 61% in both groups, while median PFS was 7.9 months at 6.4 mg/kg and 9.8 months at 9.6 mg/kg in patients with high-grade serous PROC. At the time of data cutoff, 45% of patients remained on treatment, and PFS data continue to mature, especially at 6.4 mg/kg. ZW191 continued to demonstrate a favorable tolerability profile, particularly at 6.4 mg/kg. Grade 3 or higher treatment-related adverse events occurred in 22% of patients receiving 6.4 mg/kg compared with 44% at 9.6 mg/kg. Treatment-emergent adverse events leading to dose reductions occurred in 5% and 33% of patients, respectively, while discontinuations due to adverse events occurred in 14% and 19%. No deaths due to treatment-emergent adverse events were reported in either treatment group. The overall safety profile was manageable and supports continued clinical development. “These results are particularly promising for patients with platinum-resistant ovarian cancer who have exhausted available treatment options,” said Jung-Yun Lee, M.D., Ph.D., Yonsei Cancer Center and Severance Hospital, Seoul, Republic of South Korea, and primary investigator who presented the results at ESMO 2026. “We observed substantial anti-tumor activity in patients who had received multiple prior therapies, including meaningful responses across high, intermediate and low or negative FRα expression levels. The encouraging durability of responses, together with the favorable safety profile observed at the lower dose, suggests ZW191 has the potential to become an important new treatment option for patients with this difficult-to-treat disease.” The findings demonstrate encouraging anti-tumor activity across the 6.4 mg/kg and 9.6 mg/kg dose levels, with a more favorable tolerability profile at 6.4 mg/kg. These results will inform optimal dose selection for further clinical development. ZW191's differentiated profile, including its novel FRα-targeting antibody, proprietary topoisomerase I inhibitor payload, ZD06519, and high drug-to-antibody ratio, supports its potential to address key limitations of existing therapies and broaden the applicability of FRα-targeted treatment approaches. The presentation will be available on Zymeworks’ website at www.zymeworks.com/publications/. Investor Call Details Zymeworks invites investors and the general public to view and listen to a live webcast of its conference call with investment analysts at 8:30 am ET on October 27, 2026. Dial-in details and webcast link are available on Zymeworks’ website at https://ir.zymeworks.com/events-and-presentations. A webcast replay of the call will be available on the Zymeworks website within 24 hours following the conclusion of the live call and will be archived for a limited period. About ZW191 ZW191 is an antibody-drug conjugate engineered to target a protein called folate receptor-⍺ found in ~75% of high-grade serous ovarian carcinomas,1 over 50% of endometrial cancers,2,3 and ~70% of lung adenocarcinomas4. ZW191’s differentiated design strongly supports its ability to internalize into FR⍺-expressing cells with the potential to release bystander active topoisomerase-1 inhibitor (ZD06519), a novel proprietary payload developed by Zymeworks to kill tumor cells. The Company has engaged MTS Healthcare to evaluate strategic partnering opportunities to fund further development for ZW191 with the objective of maximizing long-term value. About Zymeworks Inc. Zymeworks is a global biotechnology company building a diversified portfolio of healthcare assets designed to generate durable cash flows while advancing innovative medicines for difficult-to-treat diseases. The Company’s asset and royalty aggregation strategy combines a growing portfolio of commercial and near-commercial assets, including YUPELRI® (revefenacin), with a differentiated internal research and development engine. Zymeworks’ portfolio also includes Ziihera® (zanidatamab-hrii), a HER2-targeted bispecific antibody discovered and developed by Zymeworks and commercialized through global partnerships with Jazz Pharmaceuticals and BeOne Medicines, and pasritamig, a clinical-stage multispecific antibody developed by Johnson & Johnson using Zymeworks’ proprietary antibody engineering technologies. Zymeworks is advancing a diverse pipeline of novel biotherapeutics, leveraging its proprietary Azymetric™ platform and expertise in antibody-drug conjugates, multispecific antibodies and other next-generation antibody technologies. These capabilities, together with Zymeworks’ integrated drug development expertise, enable the Company to develop differentiated therapeutics and create value through both internal innovation and strategic partnerships. For more information about Zymeworks, its portfolio and pipeline, visit www.zymeworks.com and follow @ZymeworksInc on X. Cautionary Note Regarding Forward-Looking Statements This press release includes “forward-looking statements” or information within the meaning of the applicable securities legislation, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include, but are not limited to, statements that relate to the potential safety profile and therapeutic effects of ZW191; Zymeworks’ development of product candidates; status of studies and the related data; anticipated clinical data presentations; Zymeworks’ implementation of its long-term strategy; and other information that is not historical information. When used herein, words such as “plan”, “believe”, “expect”, “may”, “continue”, “anticipate”, “potential”, “will”, “on track”, “progress”, “preserve”, “intend”, “could”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation: any of Zymeworks’ or its partners’ product candidates, including ZW191, may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; Zymeworks may not achieve milestones or receive additional payments or royalties under its collaborations; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of new or changing laws and regulations; market conditions, including the impact of tariffs; potential negative impacts of FDA regulatory delays and uncertainty around recent policy developments, changes in the leadership of federal agencies such as the FDA, staff layoffs, budget cuts to agency programs and research, and changes in drug pricing controls; the impact of global and regional geopolitical or public health developments on Zymeworks’ business, research and clinical development plans and timelines and results of operations, including impact on its clinical trial sites, collaborators, and contractors who act for or on Zymeworks’ behalf; zanidatamab may not be successfully commercialized; Zymeworks’ business strategy related to anticipated and potential future milestones and royalty streams and existing and potential new partnerships may not be successfully implemented; Zymeworks’ evolution of its business strategy may not deliver meaningful shareholder returns; Zymeworks may be unsuccessful in actively managing and/or aggregating revenue generating assets alongside its active R&D operations; ongoing and future clinical trials may not demonstrate safety and efficacy of any of Zymeworks’ or its collaborators’ product candidates, including ZW191; Zymeworks’ assumptions and estimates regarding its financial condition, future financial performance and estimated cash runway may be incorrect; inability to maintain or enter into new partnerships or strategic collaborations; and the factors described under “Risk Factors” in Zymeworks’ quarterly and annual reports filed with the Securities and Exchange Commission (copies of which may be obtained at www.sec.gov and www.sedarplus.ca). Although Zymeworks believes that such forward-looking statements are reasonable, there can be no assurance they will prove to be correct. Investors should not place undue reliance on forward-looking statements. The above assumptions, risks and uncertainties are not exhaustive. Forward-looking statements are made as of the date hereof and, except as may be required by law, Zymeworks undertakes no obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances, or to reflect the occurrences of unanticipated events. Contacts: Investor Inquiries: Shrinal InamdarVice President, Investor Relations(604) 678-1388ir@zymeworks.com Media Inquiries: Diana PapoveVice President, Corporate Communications(604) 678-1388media@zymeworks.com --- 1 Köbel, M., Madore, J., Ramus, S. et al., Br J Cancer 111, 2297–2307 (2014).2 May B, Conway N, Truong T, Linhart S, et al. FRα, B7-H4, & HER2 Expression in Endometrial Cancer: Assessing the Promise of Antibody Drug Conjugate Therapies. Presented at: SGO 2025 Winter Meeting; January 30 - February 1, 2025; Whistler, British Columbia, Canada.3 Senol S, Ceyran AB, Aydin A, Zemheri E, Ozkanli S, Kösemetin D, Sehitoglu I, Akalin I. Folate receptor α expression and significance in endometrioid endometrium carcinoma and endometrial hyperplasia. Int J Clin Exp Pathol. 2015 May 1;8(5):5633-41.4 O'Shannessy DJ, et al., Oncotarget. 2012 Apr; 3(4):414-25.

Phase 1Clinical ResultADC

23 Oct 2026

·www.biospace.com

Zymeworks Enters into an Exclusive Global License and Collaboration Agreement with Roche for ZW209, a Trispecific T cell Engager Targeting DLL3

Zymeworks to receive a $55 million upfront payment and a $40 million payment upon initiation of the Phase 1b trial, with potential for up to $718 million in additional development, commercial and sales-based milestones Zymeworks also eligible to receive tiered high-single-digit to mid-teen royalties on global net sales protected by patents extending into 2040’s Zymeworks will conduct the Phase 1a monotherapy clinical trial of ZW209 in collaboration with Roche U.S. FDA IND clearance received with additional global regulatory applications planned to support the opening of clinical study sites outside the U.S. Transaction is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 Conference call with Zymeworks management on October 27 at 8:30 am Eastern Time (ET) VANCOUVER, British Columbia, Oct. 23, 2026 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a biotechnology company managing a portfolio of licensed healthcare assets while developing a diverse pipeline of novel, multifunctional biotherapeutics, today announced that it has entered into a global license and collaboration agreement with Roche for the research, development and commercialization of ZW209, a T cell engager targeting DLL3. Under the agreement, Zymeworks is eligible to receive an upfront payment of $55 million, a $40 million payment upon initiation of the Phase 1b trial, and additional development, commercial and sales-based milestone payments of up to $718 million, and tiered high single digit to mid-teen royalties on future net sales of any approved medicines resulting from the collaboration. The transaction remains subject to the expiration or termination of the applicable waiting period under the HSR Act, as well as the satisfaction of other customary closing conditions and, where applicable, receipt of other required regulatory approvals. Zymeworks will conduct the Phase 1a monotherapy trial of ZW209 in collaboration with Roche, bringing together Zymeworks’ expertise in multispecific antibody therapeutics with Roche’s global capabilities in the research, development, manufacturing and commercialization of cancer medicines. Roche will fund the Phase 1a trial and be responsible for subsequent global development and commercialization of ZW209. Under the agreement, Roche will have the exclusive right to develop and commercialize ZW209 globally. “This collaboration allows us to continue advancing ZW209 through its initial clinical development while leveraging Roche’s complementary capabilities to accelerate and expand its development across indications and treatment settings. The agreement also reflects our broader strategy of generating innovative programs through our R&D engine and partnering selected assets in ways that share development risk while preserving meaningful participation in their future success,” said Adam Schayowitz, Ph.D., MBA, Executive Vice President and Head of R&D at Zymeworks. “ZW209 represents an innovative approach that complements our ongoing efforts to develop new treatment options for people living with lung cancer,” said Boris L. Zaïtra, Head of Corporate Business Development at Roche. “We look forward to collaborating with Zymeworks to fully explore its therapeutic potential.” The collaboration is part of Zymeworks’ broader strategic initiative to advance differentiated therapeutic candidates internally while selectively partnering programs where complementary capabilities can accelerate development, expand potential and share development risk. Beyond ZW209, Zymeworks has an extensive portfolio of research programs of multispecific T cell engagers against targets in solid tumors, hematological tumors, and AIID. Investor Call Details Zymeworks invites investors and the general public to view and listen to a live webcast of its conference call with investment analysts at 8:30 am ET on October 27, 2026. Dial-in details and webcast link are available on Zymeworks’ website at A webcast replay of the call will be available on the Zymeworks website within 24 hours following the conclusion of the live call and will be archived for a limited period. About ZW209 ZW209 is a novel trispecific T cell engager (TriTCE), developed to target DLL3-expressing tumor cells while simultaneously engaging T cells via binding to CD3 and CD28. Optimally configured using Zymeworks’ novel TriTCE Co-Stim and clinically validated Azymetric™ and EFECT™ platforms, ZW209 is designed to enhance patient anti-tumor T cell responses through CD28 co-stimulation. By leveraging obligate cis-T cell binding and conditional CD28 engagement, ZW209 is structured to prevent unintended T cell activation, while enabling tumor-targeted cytotoxicity. Preclinically ZW209 has demonstrated differentiated long-term cytotoxicity in vitro, with enhanced T cell proliferation and survival, offering significant potential to increase durability of responses in DLL3-expressing cancers. With U.S. Food and Drug Administration Investigational New Drug clearance received, a Phase 1, open-label, multicenter, global study investigating ZW209 has been initiated to evaluate safety, tolerability, pharmacokinetics, and preliminary antitumor activity. The study will enroll adult participants with select advanced solid tumors, including small cell lung cancer and other DLL3 expressing neuroendocrine tumors. About Zymeworks Inc. Zymeworks is a global biotechnology company building a diversified portfolio of healthcare assets designed to generate durable cash flows while advancing innovative medicines for difficult-to-treat diseases. The Company’s asset and royalty aggregation strategy combines a growing portfolio of commercial and near-commercial assets, including YUPELRI® (revefenacin), with a differentiated internal research and development engine. Zymeworks’ portfolio also includes Ziihera® (zanidatamab-hrii), a HER2-targeted bispecific antibody discovered and developed by Zymeworks and commercialized through global partnerships with Jazz Pharmaceuticals and BeOne Medicines, and pasritamig, a clinical-stage multispecific antibody developed by Johnson & Johnson using Zymeworks’ proprietary antibody engineering technologies. Zymeworks is advancing a diverse pipeline of novel biotherapeutics, leveraging its proprietary Azymetric™ platform and expertise in antibody-drug conjugates, multispecific antibodies and other next-generation antibody technologies. These capabilities, together with Zymeworks’ integrated drug development expertise, enable the Company to develop differentiated therapeutics and create value through both internal innovation and strategic partnerships. For more information about Zymeworks, its portfolio and pipeline, visit and follow @ZymeworksInc on X. Cautionary Note Regarding Forward-Looking Statements This press release includes “forward-looking statements” or information within the meaning of the applicable securities legislation, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include, but are not limited to, statements that relate to Zymeworks’ expectations regarding implementation of its long-term strategy to maximize value creation; Zymeworks’ and its partners’ clinical development of product candidates; potential safety pro therapeutic effects of product candidates; the commercial potential of technology platforms and product candidates; the anticipated benefits of its collaboration agreements; and other information that is not historical information. When used herein, words such as “plan”, “believe”, “expect”, “may”, “continue”, “anticipate”, “potential”, “will”, “on track”, “progress”, “preserve”, “intend”, “could”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation: any of Zymeworks’ or its partners’ product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; uncertainties regarding the commercial success of YUPELRI® and TRELEGY; Zymeworks may not achieve milestones or receive additional payments or royalties under its collaborations; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of new or changing laws and regulations; market conditions, including the impact of tariffs; potential negative impacts of FDA regulatory delays and uncertainty around recent policy developments, changes in the leadership of federal agencies such as the FDA, staff layoffs, budget cuts to agency programs and research, and changes in drug pricing controls; the impact of pandemics and other health crises on Zymeworks’ business, research and clinical development plans and timelines and results of operations, including impact on its clinical trial sites, collaborators, and contractors who act for or on Zymeworks’ behalf; zanidatamab may not be successfully commercialized; Zymeworks’ business strategy related to anticipated and potential future milestones and royalty streams and existing and potential new partnerships may not be successfully implemented; Zymeworks’ evolution of its business strategy may not deliver meaningful stockholder returns; Zymeworks may be unsuccessful in actively managing and/or aggregating revenue-generating assets alongside its active R&D operations; ongoing and future clinical trials may not demonstrate safety and efficacy of any of Zymeworks’ or its collaborators’ product candidates; data providing early validation of our antibody drug conjugate platform and next generation pipeline programs may not be replicated in future studies; Zymeworks’ assumptions and estimates regarding its financial condition, future financial performance and estimated cash runway may be incorrect; inability to maintain or enter into new partnerships or strategic collaborations; the inability of Zymeworks to identify and consummate a strategic acquisition; and the factors described under “Risk Factors” in Zymeworks’ quarterly and annual reports filed with the Securities and Exchange Commission (copies of which may be obtained at and ). Although Zymeworks believes that such forward-looking statements are reasonable, there can be no assurance they will prove to be correct. Investors should not place undue reliance on forward-looking statements. The above assumptions, risks and uncertainties are not exhaustive. Forward-looking statements are made as of the date hereof and, except as may be required by law, Zymeworks undertakes no obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances, or to reflect the occurrences of unanticipated events. Contacts: Investor Inquiries: Shrinal Inamdar Vice President, Investor Relations (604) 678-1388 ir@zymeworks.com Media Inquiries: Diana Papove Vice President, Corporate Communications (604) 678-1388 media@zymeworks.com

License out/inPhase 1ADC

100 Deals associated with Revefenacin

External Link

KEGG	Wiki	ATC	Drug Bank
D10978	Revefenacin	R03BB08	DB11855

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Pulmonary Disease, Chronic Obstructive	United States	Mylan Ireland Ltd.	09 Nov 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Respiratory Failure	Phase 2	United States	Theravance Biopharma, Inc.	01 Nov 2020
Respiratory Failure	Phase 2	United States	Mylan Pharmaceuticals, Inc.	01 Nov 2020
Respiratory Insufficiency	Phase 2	United States	Mylan Pharmaceuticals, Inc.	01 Nov 2020
Respiratory Insufficiency	Phase 2	United States	Theravance Biopharma, Inc.	01 Nov 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04315558 (RARICO, CTgov)	Phase 2	Respiratory Failure \| Pulmonary Disease, Chronic Obstructive \| Respiratory Insufficiency	21	Revefenacin Inhalation Solution [Yupelri] (Revefenacin)	mjdlquexny = qbpsycosiy ichlxzhlkr (nntlnlzneh, rjvhkssfsj - fiiiqgmurd) View more	-	14 Oct 2026
				Ipratropium Bromide (Ipratropium)	mjdlquexny = qnyvpkxomj ichlxzhlkr (nntlnlzneh, moiwtaqhhw - hwdqmitcmm) View more
NCT04655170 (CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive	60	Revefenacin (YUPELRI)+Formoterol (Perforomist) (Experimental: Group 1: Revefenacin (YUPELRI) & Formoterol (Perforomist))	lzmkcibsdj(hzflqnungq) = nxtiyblsod quddezngal (auzrtxwcgv, vcxyahgxyo - rkqsqpqnul) View more	-	03 Aug 2026
				Albuterol(Ventolin)+Ipratropium Bromide (Atrovent) (Active Comparator: Group 2: Ipratropium Bromide (Atrovent) & Albuterol(Ventolin) as Standard of Care)	lzmkcibsdj(hzflqnungq) = qeuydfechl quddezngal (auzrtxwcgv, wcbofxpigy - tvjaugpfbh) View more
0128 (ATS2026)	Not Applicable	Pulmonary Disease, Chronic Obstructive	1,055	Revefenacin 175 mcg	kkwikoaivz(qzalgrtgsr) = ntuirgtcex tfzkvknxrf (sszzdufszc ) View more	Positive	15 May 2026
				Tiotropium	-
NCT05165485 (PIFR-2, CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive	404	Revefenacin Placebo+Tiotropium (Tiotropium)	xldihekdmy(danmmackcl) = nsszvgeoof ckqlkzwvmx (tzmcqjmfiy, 17) View more	-	20 Dec 2024
				Tiotropium Placebo+Revefenacin (Revefenacin)	xldihekdmy(danmmackcl) = oeispjgrkw ckqlkzwvmx (tzmcqjmfiy, 17) View more
NCT05046795 (CTgov)	Phase 3	Pulmonary Disease, Chronic Obstructive	258	Revefenacin 175 mcg in 3 ML Inhalation Solution (Revefenacin Inhalation Solution 175 mcg QD.)	byhnbaukfd(tiufswwyau) = zknzebndny puvyylamok (hgacylsygz, 23.974) View more	-	01 Nov 2024
				Placebo inhalation solution QD (Placebo Inhalation Solution QD.)	byhnbaukfd(tiufswwyau) = tgdedtdqea puvyylamok (hgacylsygz, 24.504) View more
NCT02512510 (Pubmed \| Int J Chron Obstruct Pulmon Dis)	Phase 3	Pulmonary Disease, Chronic Obstructive	97	Revefenacin 175 μg	zdsnesdptl(xehmyhdpui) = aqdiyfzbnb epionasuib (tuipfqdwtj ) View more	Positive	01 Oct 2024
				Placebo	-
NCT05165485 (PIFR-2, PRNewswire) Manual	Phase 4	Pulmonary Disease, Chronic Obstructive	404	Revefenacin	jjcrpujndt(cvszftcexp) = The study did not show a statistically significant difference between YUPELRI and Spiriva HandiHaler. ngxvxzwvdq (uellxmobel ) Not Met	Negative	05 Jan 2024
				Tiotropium
NCT05046795 (PRNewswire) Manual	Phase 3	Pulmonary Disease, Chronic Obstructive	257	YUPELRI	rbimyuiqcn(fxjrtlvthq): Difference = 150.9 (95% CI, 104.1 - 197.7) View more	Positive	13 Nov 2023
				placebo
ATS2021	Not Applicable	Severe chronic obstructive pulmonary disease	-	Revefenacin 175 µg	kmzdzktcgv(sikjfkufjv) = vlolcfnpli akdxxudyvi (bmhsuhvgfv, 85.7 - 178.0)	-	03 May 2021
NCT03573817 (Pubmed \| Chronic Obstr Pulm Dis) Manual	Phase 3	Pulmonary Disease, Chronic Obstructive	122	formoterol+revenacin	btptnljekt(bjuebkjzqy) = udyvhmmfyo hddbcrptna (lbsjctpucj ) View more	Positive	01 Apr 2020
				formoterol+Placebo	btptnljekt(bjuebkjzqy) = rvuqizoryh hddbcrptna (lbsjctpucj ) View more

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