Budesonide/Formoterol Fumarate Dihydrate

AstraZeneca and Daiichi Sankyo have changed up their approval plans for a closely watched lung cancer medicine, a decision that could limit the sales potential of a drug viewed by Wall Street analysts as a blockbuster in the making.On Tuesday, the companies said that, after discussions with U.S. regulators, theyve withdrawn an approval application for a drug called datopotamab deruxtecan, or dato-dxd, in a common form of lung cancer.The partners have replaced that filing with a new one focused on a narrower group of people whose metastatic, non-small cell lung tumors are driven to growth by mutations in a gene known as EGFR. Within that group, theyre aiming for an “accelerated“ approval in people whove received prior systemic therapies, among them a drug that targets EGFR specifically.The companies estimate that EGFR mutations are found in anywhere from 10% to 15% of people with non-small cell lung cancer in the U.S. and Europe, and about 30% to 40% of those in Asia.For AstraZeneca and Daiichi, the new request trims dato-dxds potential. The drug is one of several antibody-drug conjugates the companies are developing in hopes these therapies can supplant chemotherapy in many tumor types.The first of those drugs, Enhertu, succeeded in several key trials and, in the process, changed how certain breast cancers are treated. Its now one of AstraZenecas best-selling cancer medicines, earning it $510 million in global sales in the third quarter, the company reported Tuesday.AstraZeneca and Daiichi are hoping for a similar success with dato-dxd. They initially aimed to bring the drug to market for people whose non-small cell lung tumors express a protein, TROP2, that its designed to target and thats overexpressed in most lung cancers.But dato-dxd didnt significantly extend survival in a Phase 3 study testing it directly against the chemotherapy docetaxel. The companies then focused on the drugs apparent benefit against tumors classified as nonsquamous, a group for which they believed dato dxd might be most helpful. They filed an approval application for use in those patients specifically, setting up a decision by the Food and Drug Administration that was expected by late December.Yet study results presented at a medical meeting in September showed dato-dxd didnt meaningfully extend survival in that group either, complicating the companies argument. Analysts at the time questioned whether the FDA might delay its decision or call on a panel of advisers to further scrutinize the data. Instead, after consulting with regulators, AstraZeneca and Daiichi have found another solution, turning to a combination of results from a trio of trials to secure a more limited approval.According to the companies, a new, pooled analysis from two of those studies and focused specifically on people with previously treated, EGFR-mutated non-small lung cancer will be presented at a medical meeting in Asia next month.The findings showed an especially pronounced benefit in those patients, which informed our discussions with the FDA, said Susan Galbraith, AstraZenecas head of oncology R&D, in the statement.The companies revised approval plans are a setback but not entirely unanticipated, wrote Jefferies analyst Peter Welford, adding that the new strategy also removes the risk of a rejection altogether.Dato-dxd is being evaluated alongside another AstraZeneca medicine, Tagrisso, in a pair of Phase 3 trials in EGFR-mutated, nonsquamous non-small cell lung cancer. The drug is also under an FDA review in breast cancer, but mixed study results have led to questions about its approval prospects in that indication as well. A decision is expected by early 2025.AstraZeneca reported third quarter earnings alongside the announcement. Revenues of about $13.6 billion exceeded consensus analyst estimates by 4%, driven in part by better than expected results for the asthma medicine Symbicort and rare disease drug Ultomiris.The company also raised its financial outlook for the year. It now expects revenue to grow by a high teens percentage, versus the mid teens percentage increase it previously projected. '

PITTSBURGH, Aug. 8, 2024 /PRNewswire/ --Strong Results Demonstrate Power of Company's Diversification, Execution and Growing Base Business Continue Reading View PDF Viatris Reports Second Quarter Financial Results for 2024. View PDF Viatris Reports Second Quarter Financial Results for 2024. Total Revenues of $3.8 Billion and Operational Revenue Growth of ~2% on a Divestiture-Adjusted Basis[1] Strong New Product Revenues in the Quarter of $210 Million Drove Growth Across Segments U.S. GAAP Net Loss was $326 Million; Adjusted EBITDA Grew ~2% to $1.2 Billion on a Divestiture-Adjusted Basis; U.S. GAAP Diluted EPS was a Loss of $0.27 per Share; Adjusted EPS Grew ~3% to $0.69 per Share on a Divestiture-Adjusted Basis[2] Completion of Divestitures Marks Inflection Point in Company's Move Towards Accelerated Growth and Shareholder Return Raises 2024 Full-Year New Product Revenues Range to $500 Million-$600 Million Expects 2024 Full-Year Total Revenues Growth of ~2% on a Divestiture-Adjusted Operational Basis[3] Viatris Inc. (NASDAQ: VTRS) today announced strong financial results for the second quarter of 2024, including total revenues of $3.8 billion and new product revenues of $210 million, demonstrating the Company's ability to continue to grow its diversified base business. With the substantial completion of its divestitures the Company believes it has increased its financial strength and has a strong foundation from which to accelerate growth and shareholder return. "I am pleased to report strong second quarter results in which we delivered divestiture-adjusted operational revenue growth across all segments, including strong growth in Greater China. This represents our fifth consecutive quarter of divestiture-adjusted operational revenue growth and demonstrates our ability to execute and grow our base business," said Scott A. Smith, CEO, Viatris. "With our divestitures behind us and a strong foundation to build on, we believe we are at an inflection point for our Company. In our next chapter, our strategy will focus on three main pillars: our diversified and growing base business, our financial strength and significant cash flow, and our expanding innovative portfolio. We expect these three pillars will enable us to accelerate growth and shareholder return." "Our solid fundamentals, including our growing base business, our financial strength and our ability to generate significant cash flow drove our second quarter results," said Doretta Mistras, CFO, Viatris. "We had another quarter of divestiture-adjusted operational revenue growth, up approximately two percent, which benefited from strong new product revenues. Adjusted EBITDA grew approximately two percent and adjusted EPS grew approximately three percent in the quarter, each on a divestiture-adjusted operational basis, supported by strong gross margins and disciplined investment to advance our pipeline. We expect the momentum we are seeing in the business to continue and we believe we are well positioned for a strong second half of the year." [1] For the quarter ended June 30, 2024, total revenues declined ~3% on a U.S. GAAP basis to $3.8 billion. [2] For the quarter ended June 30, 2024, U.S. GAAP net earnings (loss) declined from $264 million to ($326 million), and U.S. GAAP diluted EPS declined from $0.22 per share to ($0.27) per share on a U.S. GAAP basis. [3] U.S. GAAP total revenues for 2024 as of August 8, 2024, is estimated to be between $14.60 and $15.10 billion, with a midpoint of $14.85 billion or a full-year decrease of ~4%. Please see "Financial Guidance" and "Non-GAAP Financial Measures" for additional information. Financial Highlights Second quarter 2024 total net sales were $3.8 billion, up ~2% on a divestiture-adjusted operational basis compared to second-quarter 2023 results, with divestiture-adjusted operational net sales growth across all segments. Brands net sales reflect strong growth in Greater China and the expansion of the Company's portfolio in Emerging Markets and JANZ. This was partially offset by unfavorable channel dynamics in North America and the impact of government price regulations in Japan and Australia. Generics net sales reflect strong growth from new product launch performances in Developed Markets, continued growth from complex products, and solid performance across our broader European portfolio. The Company generated approximately $210 million in new product revenues in the quarter primarily driven by Breyna™, lisdexamfetamine, and other new products globally. The Company's strong year-to-date performance gives it confidence in raising its outlook to approximately $500 million to $600 million in new product revenues in 2024. U.S. GAAP net loss was $326 million and adjusted EBITDA was $1.2 billion, up ~2% on a divestiture-adjusted operational basis. U.S. GAAP diluted EPS was a loss of $0.27 per share and adjusted EPS was $0.69 per share, up ~3% on a divestiture-adjusted operational basis. This quarter's results demonstrate the Company's financial strength, as the Company generated U.S. GAAP net cash provided by operating activities of $379 million, and free cash flow, excluding the impact of transaction costs primarily related to the divestitures, of $426 million, and paid down approximately $800 million of debt. Additional Updates In July, the Company brought to substantial completion all divestitures with the closing of its Over-the-Counter (OTC) business to Cooper Consumer Health, a leading European over-the-counter drug manufacturer and distributor. In June, the Company was named to TIME's World's Most Sustainable Companies 2024 List recognizing leading companies in corporate social responsibility from more than 30 countries. In May, the Company published its 2023 Sustainability Report highlighting its actions and initiatives across multiple areas of focus in support of the Company's efforts to continue to be a model for sustainable access to medicine and to make a difference in the communities it serves. Financial Guidance The following table summarizes the Company's 2024 financial guidance as of August 8, 2024. The Company is not providing forward-looking guidance for U.S. GAAP net (loss) earnings or U.S. GAAP diluted (loss) earnings per share (EPS) or a quantitative reconciliation of its 2024 adjusted EBITDA or adjusted EPS guidance to the most directly comparable U.S. GAAP measures, U.S. GAAP net (loss) earnings 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, and other contingencies, such as changes to contingent consideration, acquired IPR&D and certain other gains or losses, including for the fair value accounting for non-marketable equity investments, 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 provided as of August 8, 2024, U.S. GAAP net cash provided by operating activities for 2024 is estimated to be between $2.62 billion and $2.92 billion, with a midpoint of approximately $2.77 billion. With respect to the Estimated Ranges provided as of May 9, 2024, Viatris did not provide forward-looking guidance for U.S. GAAP net earnings or U.S. GAAP diluted EPS or a quantitative reconciliation of its 2024 adjusted EBITDA or adjusted EPS guidance. Please see "Non-GAAP Financial Measures" for additional information. With respect to the Estimated Ranges provided on May 9, 2024, U.S. GAAP net cash provided by operating activities for 2024 was estimated to be between $2.71 billion and $3.01 billion, with a midpoint of approximately $2.86 billion. The Company currently expects to be at the midpoint of the August 8, 2024, guidance ranges. Conference Call and Earnings Materials Viatris will host a conference call and live webcast, today at 8:30 a.m. ET, to review the Company's second quarter 2024 financial results. 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 Q2 2024 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 uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health challenges, access takes on deep meaning at Viatris. 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 (formerly Twitter). 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 costs primarily related to the divestitures, 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, and divestiture-adjusted operational change, 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. Divestiture-adjusted operational change refers to operational change, further adjusted for the impact of divestitures that have closed during 2023 and 2024 by excluding proportionate net sales from those divested businesses from comparable prior periods. The "Summary of Total Revenues by Segment" table below compares net sales on an actual and constant currency basis for each reportable segment for the quarters and six months ended June 30, 2024 and 2023 as well as for total revenues, as well as divestiture adjusted operational change in net sales and total revenues. 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 months ended June 30, 2024. With respect to the Estimated Ranges as provided as of May 9, 2024, 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 2024 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 and other contingencies, such as changes to contingent consideration, acquired IPR&D and certain other gains or losses, including for the fair value accounting for non-marketable equity investments, 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 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 included the full-year expected performance for the then-pending announced divestiture of substantially all of our OTC business and excluded any potential related costs, such as taxes and transaction costs, as well as any acquired IPR&D to be incurred in any future period as it could not be reasonably forecasted. Certain Key Terms and Presentation Matters New product sales, new product launches or new product revenues: Refers to revenue from new products launched in 2024 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 2024 constant currency net sales, revenues, adjusted EBITDA, and adjusted EPS to the corresponding amount in the prior year. Divestiture-adjusted operational change: Refers to operational changes, further adjusted for the impact of the proportionate results from the divestitures that closed in 2023 and 2024, from the 2023 period by excluding such net sales from those divested businesses from comparable prior periods. Also, for adjusted EBITDA and adjusted EPS, refers to operational changes, adjusted as outlined in the previous sentence and further adjusted for the mark up for the TSA services provided to Biocon Biologics from the 2023 period. SG&A and R&D TSA reimbursement: Expenses related to TSA services provided for divested businesses are recorded in their respective functional line item; however, reimbursement of those expenses plus the mark-up is included in other expense (income), net. For comparability purposes, amounts related to the cost reimbursement were reclassified to adjusted SG&A and adjusted R&D during 2023 and the first quarter of 2024. This reclassification had no impact on adjusted net earnings, adjusted EBITDA or adjusted EPS. Closed divestitures or divestitures closed in 2023 and 2024: Refers to the divestiture of the Company's rights to two women's healthcare products in certain countries (other than the U.K., which remains subject to regulatory approval) that closed in December 2023, the divestitures of the commercialization rights in certain of the Upjohn Distributor markets that closed in 2023 and 2024, the divestiture of the women's healthcare business that closed in March 2024, and the divestiture of the API business in India that closed in June 2024. Forward-Looking Statements This 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 2024 financial guidance; strong results demonstrate power of Company's diversification, execution and growing base business; completion of divestitures marks inflection point in Company's move towards accelerated growth and shareholder return; raises 2024 full-year new product revenues range to $500-$600 million; expects 2024 full-year total revenue growth of ~2% on a divestiture-adjusted operational basis; the Company's ability to continue to grow its diversified base business; with the substantial completion of its divestitures the Company believes it has increased its financial strength and has a strong foundation from which to accelerate growth and shareholder return; this represents our fifth consecutive quarter of divestiture-adjusted operational revenue growth and demonstrates our ability to execute and grow our base business; with our divestitures behind us and a strong foundation to build on, we believe we are at an inflection point for our Company; in our next chapter, our strategy will focus on three main pillars: our diversified and growing base business, our financial strength and significant cash flow, and our expanding innovative portfolio; we expect these three pillars will enable us to accelerate growth and shareholder return; we expect the momentum we are seeing in the business to continue, and we believe we are well positioned for a strong second half of the year; the Company's strong year-to-date performance gives it confidence in raising its outlook to approximately $500 million to $600 million in new product revenues in 2024; the Company currently expects to be at the midpoint of the August 8, 2024, guidance ranges; the goals or outlooks with respect to the Company's strategic initiatives, including but not limited to the Company's two-phased strategic vision and potential, announced and completed divestitures, acquisitions or other transactions; the benefits and synergies of such divestitures, acquisitions, or other transactions, or restructuring programs; future opportunities for the Company and its products; and any other statements regarding the Company's future operations, financial or operating results, capital allocation, dividend policy and payments, stock repurchases, debt ratio and covenants, anticipated business levels, future earnings, planned activities, anticipated growth, market opportunities, strategies, competitions, commitments, confidence in future results, efforts to create, enhance or otherwise unlock the value of our unique global platform, 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 (including divestitures, acquisitions, or other potential transactions) or move up the value chain by focusing on more complex and innovative products to build a more durable higher margin portfolio; the possibility that the Company may be unable to achieve intended or expected benefits, goals, outlooks, synergies, growth opportunities and operating efficiencies in connection with divestitures, acquisitions, other transactions, or restructuring programs, within the expected timeframes or at all; with respect to divestitures, failure to realize the total transaction values or proceeds, including as a result of any purchase price adjustment or a failure to achieve any conditions to the payment of any contingent consideration; goodwill or impairment charges or other losses, including but not limited to related to the divestiture or sale of businesses or assets; the Company's failure to achieve expected or targeted future financial and operating performance and results; the potential impact of public health outbreaks, epidemics and pandemics; 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 (including the impact of recent and potential tax reform in the U.S. and pharmaceutical product pricing policies in China); 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, including but not limited to "at-risk launches"; 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 inspections, remediation and restructuring activities, supply chain or inventory or the ability to meet anticipated demand; 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 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, 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, 2023, as amended, 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 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 release other than as required by law. SOURCE Viatris Inc.