viatris biosimilars pipeline

Viatris global portfolio comprises more than 1,400 molecules across a broad range of major therapeutic areas, including best-in-class, iconic brand-name products, as well as global key brands, generics, including branded and complex generics, biosimilars and over-the-counter offerings. Find me at my marketplace channel, Haggerston BioHealth - model portfolio + 4 exclusive stock tips every week. If we treat free cash flow as net income, we can estimate a forward earnings per share ("EPS") figure of ~$2.2, and a forward price to earnings ("PE') ratio of ~4.75x. Viatris announced that its Board of Directors has authorized a share repurchase program of up to $1 billion. VIATRIS and the Viatris Logo are trademarks and GLOBAL HEALTHCARE GATEWAY, PARTNER OF CHOICE and the Global Healthcare Gateway logo are registered trademarks of Mylan Inc., a Viatris company. The Company maintains that it acted lawfully and pro-competitively and the settlement contains no admission of liability. With a team of ~ 4,800 people, Biocon Biologics is committed to transforming healthcare and transforming lives by enabling affordable access to millions of patients' worldwide. For the year ended December 31, 2021, charges of approximately $534.7 million are included in cost of sales, approximately $13.3 million are included in R&D, and approximately $351.5 million are included in SG&A. It is a milestone achievement for both Biocon Biologics and our partner Viatris. Viatris affiliate sites and third party sites are provided as a resource to These vital products can help increase access for current and future patients while supporting the sustainability of healthcare systems. Executive Comments Revenues. and Filings, Stock The company has a forward P/S ratio of <1x and a forward P/E ratio of <5x, suggesting it is fundamentally undervalued. applicable to this site and unaffiliated third party sites are subject to Areas, Working The new company brings together Mylan's diverse portfolio across many geographies and key therapeutic areas and its robust pipeline, high-quality manufacturing, and supply chain excellence with Upjohn's trusted brands and proven commercialization capabilities, including leadership positions in China and other emerging markets. Products disclosed may change in future periods, including as a result of seasonality, competition or new product launches. # In-licensed molecules. Any company that wants to be successful in the long term needs to have a growth plan, but it is tricky to discern precisely what that plan is in the case of Viatris. Currency impact is shown as unfavorable (favorable). You are now leaving this page for a Viatris affiliate site Such measures also do not reflect the effect of any purchase accounting adjustments, including but not limited to the elimination of intercompany sales and the fair value of assets and liabilities. Biocon Biologics, Executive Chairperson, Kiran Mazumdar-Shaw said: "We are extremely proud to be the first to obtain approval of an interchangeable Biosimilar product in the U.S. Severe, life-threatening generalized allergy, including anaphylaxis can occur with insulin products, including Semglee. U.S. GAAP earnings from operations is calculated as U.S. GAAP gross profit less U.S. GAAP total operating expenses. $16.5bn of revenues and a 25% profit margin is arguably better than $20bn of revenues and a 15% margin, but when does a lack of growth become a problem? Pursuant to the transaction documents, Biocon Biologics will target an initial public offering (IPO) in India as early as late 2023. U.S. GAAP net cash provided by operating activities for 2022 is estimated to be between $3.2 billion and $3.4 billion, with a midpoint of approximately $3.3 billion. It's not quite clear what the growth plan is at present - if it wasn't so significantly undervalued, I'd be looking to sell. Viatris' pipeline now looks thin and its revenues are very likely to keep shrinking. Webcast Information Viatris Inc. (NASDAQ: VTRS) is a new kind of healthcare company, empowering people worldwide to live healthier at every stage of life. I wrote this article myself, and it expresses my own opinions. October 18, 2022; Biosimilar Bytes . Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. 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. Post closure of the deal, Biocon Biologics will realize the full revenue and associated profits from its products partnered with Viatris, which is a step-up . PITTSBURGH, Nov. 7, 2022 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS) today reported strong results for the third quarter of 2022 and reaffirmed its 2022 financial guidance. A generic version of Novo Nordisk's GLP-1 receptor agonist Wegovy (semaglutide) treatment for obesity is among seven complex generic injectables for which Viatris is claiming first-to-file status, as it looks to return to growth in 2024 and beyond. Our diverse and differentiated portfolio, supported by world-class commercial and regulatory expertise, delivers trusted, quality medicines that treat nine out of 10 of the World Health Organizations (WHO) leading causes of death and more than 200 of our medicines are on the WHO Essential Medicines List. U.S. GAAP gross margin is calculated as U.S. GAAP gross profit divided by total revenues. 400+ Acquisition related costs consist primarily of transaction costs including legal and consulting fees and integration activities. We believe that executing on our recently announced initiatives will not only unlock value and provide additional access to capital but will also accelerate our Phase I financial commitments, increase our investments into the business, while returning additional capital to our shareholders, including our announced Board authorization of a share repurchase program.". 2022 Financial Guidance $3.3B deal with Mylan-Upjohn offshoot gives Indian biotech leader pipeline of 20 biosimilars and over $1B in revenue. Leaders, Corporate Viatris is committed to improving the health and well-being of communities just like yours through strong partnerships dedicated to providing education, outreach, and better access to treatment. 2022, the two companies reached a definitive agreement wherein Biocon Biologics will acquire substantially all of Viatris' biosimilars portfolio globally, including Abevmy; the transaction will create a . Links to I wrote this article myself, and it expresses my own opinions. or third party site that is solely responsible for its content, including About the Viatris and Biocon Biologics Collaboration About Biocon Biologics Limited Management needs to restore belief in its products and their sales potential, ensure that the company maintains or ideally increases its profitability, and create a pipeline that investors can get excited about. I am not receiving compensation for it (other than from Seeking Alpha). A reconciliation of the estimated 2022 GAAP Net Cash provided by Operating Activities to Free Cash Flow is presented below: Estimated GAAP Net Cash provided by Operating Activities, Combined Adjusted EBITDA - Three and twelve months ended December31, 2020, Twelve months ended 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 2021 constant currency net sales or revenues to the corresponding amount in the prior year. VIATRIS combines best-in-class scientific manufacturing and distribution expertise with proven regulatory, medical and commercial capabilities to bring quality medicines to patients when and where they need them. An archived version also will be available following the live event and can be accessed at the same location for a limited time. For the year ended December 31, 2021, other revenues in Developed Markets, JANZ, and Emerging Markets were approximately $51.0 million, $1.5 million, and $20.2 million, respectively. We are excited to continue our journey of moving up the value chain and leveraging our capabilities to focus on more complex and novel products. Management uses these measures internally for forecasting, budgeting, measuring its operating performance, and incentive-based awards. its compliance with guidelines applicable in certain geographies. 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. Privacy Notice, California Supply Viatris: Products, Profitability, Pipeline - Keys to Success - Looking for Alpha | Vette Leader. Story, Our From a global perspective, Viatris has over 300 approvals for 7 different biosimilar products in over 75 countries around the world. That was the dream that was sold to investors in detailed March 2021 investor day presentation - there was talk of establishing a "new kind of pharmaceutical company" but the company seems to have had its wings trimmed significantly since those hopeful days. and Inclusion, Locations You are now leaving the Viatris page for a Viatris affiliate site or third party site that is solely responsible for its content, including its compliance with guidelines applicable in certain geographies. Choose Your Viatris: MYL-1701P: Eylea: Filing expected Q4 2021: Potential FDA decision Q3-Q4 2022: Bevacizumab: . 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' Annual Report on Form 10-K for the year ended December31, 2021. The Company also announced today that following the completion of a comprehensive strategic review, it has taken the first bold step in its long-term strategy to unlock value and reshape the Company by reaching a definitive agreement with Biocon Biologics Limited ("Biocon Biologics") to contribute its biosimilars portfolio to Biocon Biologics, which will become a uniquely positioned, vertically integrated company that we expect to be a global biosimilars leader. . These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Viatris and Biocon Biologics have an exclusive collaboration for the development, manufacturing and commercialization of a broad portfolio of biosimilars and insulin analogs. See "Certain Key Terms" in this release for more information. Presently, Viatris' market cap valuation is $13bn, meaning its forward price to sales ratio is <1x, which again, in ordinary circumstances, hints at a company being undervalued. It could be a bumpy ride, but that would be preferable to an incremental slide. August 20, . ERYGEL (Erythromycin) Topical Gel, USP. Includes impact of EpiPen litigation settlement of $264 million. Toolkit, Investor EPIFOAM (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) Topical Aerosol. Below is a reconciliation of U.S. GAAP net loss to adjusted net earnings for the three months and year ended December31, 2021, compared to the prior year period: Purchase accounting related amortization (primarily included in cost of sales) (a), Interest expense (primarily amortization of premiums and discounts on long term debt), Acquisition related costs (primarily included in SG&A) (b), Selling, general and administrative expense, Tax effect of the above items and other income tax related items (f). Our Pipeline Our pipeline and research and development capabilities, which are focused on investments to continue moving the company up the value chain, include expertise in formulation, device development, toxicology, analytical, clinical, bioanalytical, medical affairs, product safety and risk management across a wide range of product types. Policy, Corporate Primarily due to acquisitions 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. Location, Purchase accounting related amortization (primarily included in cost of sales), Acquisition related costs (primarily included in SG&A), Tax effect of the above items and other income tax related items, Restructuring, acquisition related and other special items, Our applicable to this site and unaffiliated third party sites are subject to at Viatris, Diversity This allows substitution at the pharmacy counter, thus expanding patient access and sets the stage for future approvals for our other insulin products.". Choose Your Viatris intends to continue to invest in expanding its commercial and scientific capabilities in key focus areas for the future, while continuing to participate in the global biosimilars market through its ownership position in Biocon Biologics. their own terms and data protection notices and practices. ", Biocon Biologics Managing Director Arun Chandavarkar said: "This interchangeability approval for Semglee by the U.S. FDA, another first to our credit, is a testament to our scientific excellence and robust quality comparability data. Viatris will own a stake of at least 12.9% of Biocon Biologics, on a fully diluted basis. for use in your country. We currently market Zarzio 2 / Zarxio 2 , Binocrit 3 and Ziextenzo 4 , used in supportive cancer care and Rixathon 5 to treat blood cancers. If hypersensitivity reaction occurs, discontinue Semglee and treat per standard of care and monitor until symptoms and signs resolve. This transaction is the right natural next step for our partnership. their own terms and data protection notices and practices. At the time of close, which is currently expected to occur in the second half of 2022 subject to satisfaction of closing conditions, including certain regulatory approvals, Viatris will receive $3 billion in consideration in the form of a $2 billion cash payment and $1 billion of convertible preferred equity. AlixPartners acted as strategic advisor to the management team on Viatris' comprehensive strategic review. The $3.3 billion purchase by Biocon Biologics is more than 16.5 times the projected income figure. Includes amortization of premiums and discounts on long-term debt. compliance with guidelines applicable in certain geographies. Represents operational change for net sales. As responsible stewards of capital allocation, the Company strives to ensure it is maximizing value for shareholders with every decision. We deliver proven,best-in-class, medicines, including treatments for 9 out of 10 of the World Health Organizations leading causes of death. Viatris stock looks attractive based on several factors. The Company also . Information, Shareholder compliance with guidelines applicable in certain geographies. Our best-in-class manufacturing and global distribution capabilities help deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance. Viatris and Biocon Biologic's insulin glargine has received regulatory approval in more than 60 countries around the world and was the third product approved by the FDA through the Viatris-Biocon Biologics collaboration. Adjusted gross margin is calculated as adjusted gross profit divided by total revenues. You are now leaving the Viatris page for a Viatris affiliate site or third The overall sales decline in this combined category was attributed to generic drug competition. Our pipeline Our pipeline and research and development capabilities, which are focused on investments to continue moving the company up the value chain, include expertise in formulation, device development, toxicology, analytical, clinical, bioanalytical, medical affairs, product safety and risk management across a wide range of product types. or third party site that is solely responsible for its content, including The Company is providing the following financial guidance measures for fiscal year 2022. its compliance with guidelines applicable in certain geographies. Brands accounted for $2.48bn, or ~60% of revenue, Complex Gx and Biosimilars $355m, or ~9%, and generics $1.27bn, or 31%. Mylan is the accounting acquiror in the combination of Mylan N.V. with Pfizer Inc.'s Upjohn business, which was completed on November 16, 2020, and therefore the historical financial statements of Mylan for periods prior to the combination are considered to be the historical financial statements of Viatris. Operational Change Viatris believes its unlocking of value will accelerate the Company's path to financial flexibility by enabling the Company to accelerate deleveraging, to return capital to shareholders through the potential for share repurchases and further dividend growth and to invest for growth by increasing investment in R&D and engaging in targeted business development activities. Looked at in the context of debt, however, Viatris has generated $4.3bn of free cash flow over the past 6 quarters, enough to pay off ~17% of its debt. Change It will be 5 long years before Viatris can say that it is close to eradicating the level of debt it inherited, so investors should not hold out too much hope of raised dividends and expansive share buyback programs, particularly when each passing year results in a decreased top-line contribution. Significant items for the three months and year ended December31, 2021, include the following: Includes amortization of the purchase accounting inventory fair value adjustment related to the Combination totaling approximately $1.19 billion for the year ended December 31, 2021. The companies will also enter into a Transition Services Agreement ("TSA"), pursuant to which Viatris will provide certain transition services for an expected two-year period, including commercialization services. If you have an ad-blocker enabled you may be blocked from proceeding. Build a More Durable, Higher-Margin Portfolio It is almost behaving like a store holding a closing down sale. From product development to making or sourcing raw materials to producing finished dosage forms, every step of our development, manufacturing and monitoring processes is grounded in this commitment. Zealand, United Governance, Therapeutic At first, management appeared to be dedicated to establishing Viatris as a generics and biosimilar drug manufacturer and marketer of global significance, but perhaps it has all proven to be too difficult. Developing a portfolio of <$500m p.a. It has a strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other non- communicable diseases. A Levothyroxine generic has recently won approval, with a total addressable market of ~$4 - $5bn, of which it will likely only claim a very minor share. Let's look at each part of the Product / Profit / Pipeline trifecta in more detail. For the three months ended December31, 2021, other revenues in Developed Markets, JANZ, and Emerging Markets were approximately $4.4 million, $0.2 million, and $5.7 million, respectively. Links to Viatris affiliate sites and third party sites are provided as a resource to our visitors and may not be governed by the same regulatory requirements applicable to this site and unaffiliated third party sites are subject to their own terms and data protection notices and practices. March 1, 2022 2:21 AM UTC. 2.75+ billion doses of Recombinant human insulin provided to patients globally since 2004. Shrinking top line revenues does not necessarily make a business a bad one. Adjusted gross profit is calculated as total revenues less adjusted cost of sales. The U.S. biosimilars market is in for a very exciting year in 2023, largely owing to the slate of potentially 10+ biosimilar competitors anticipated to launch against the world's top selling drug of all time, Humira (adalimumab) 1.Since first launching in the U.S. in 2003, Humira as a product has evolved in many ways including new concentrations, citrate free versions, latex free . By development stage - as of October 31, 2022. You may also be interested in. Viatris comes across as a company that is praying for a Benjamin Button style existence to me. For the three months ended December31, 2021, charges of approximately $135.2 million are included in cost of sales, approximately $1.4 million are included in R&D, and approximately $21.4 million are included in SG&A. That is not necessarily management's problem, but investors who expected to see an exciting new biosimilars player emerge from the ashes of yesteryear's blockbusters may end up disappointed and out of pocket. States, Viatris Reports Strong Fourth Quarter and Full-Year 2021 Financial Results, Viatris Viatris earned $17.8bn revenues in 2021, with EBITDA of $6bn. Chain Transparency, UK and Australia Modern Slavery PITTSBURGH and BENGALURU, India, July 28, 2021 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS) and Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) today announced that the U.S. Food and Drug Administration (FDA) has approved Semglee (insulin glargine-yfgn) injection as the first interchangeable biosimilar product under the 351(k) regulatory pathway. Governance, Therapeutic Free cash flow refers to U.S. GAAP net cash provided by operating activities, less capital expenditures. Near You, Search Viatris will also have certain priority rights with respect to certain liquidity events. Viatris is committed to increasing investment in R&D development to up to approximately 9% of total revenues by 2026 and will focus on business development through its Global Healthcare Gateway to additionally drive our efforts. Although the companies are not yet profitable; Viatris has the expertise, infrastructure and marketing to make these businesses EBITDA positive. Leaders, Corporate With a float of >1.25bn shares, investors are almost certain to feel the pinch at some point, and sizeable profit margins may not appease them when net income is declining every year. The newly combined business entity, Viatris, has joined the original 9 members of the Washington, DC-based Biosimilars Forum. Generics performed better than expected, driven primarily by favorability in the JANZ and Emerging Markets segments. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway. Since Q420, Viatris has reduced its debt from $25.1bn, to $20.4bn (according to its Q222 earnings presentation), and its gross leverage from 3.7x, to 3.3x. FCF across H122 is even better - $1.79bn - up 41% year-on-year - for a margin >21%. Get them exclusively at Haggerston BioHealth. ", Viatris CEO Michael Goettlersaid: "As promised, while delivering strong financial performance in our first year, we spent 2021 conducting a comprehensive strategic review of our entire business. Sales >$500m would likely be miraculous. Advisors Viatris affiliate sites and third party sites are provided as a resource to The resolution of these indirect purchaser cases will allow the Company to move forward and continue focusing on its strategic priorities and its mission of empowering people worldwide to live healthier at every stage of life. ET. Under the terms of the agreement, Viatris will contribute to Biocon Biologics its biosimilars portfolio and related commercial and operational capabilities, amounting to 2022 estimated revenue of approximately $875 million(2) and 2022 estimated adjusted EBITDA of approximately $200 million(2), in exchange for pre-tax consideration of up to $3.335 billion, which represents a transaction multiple of 16.5x of estimated 2022 biosimilars adjusted EBITDA. and Filings, Stock Certain Key Terms Important factors that could cause actual results to differ materially from our expectations include, amongst other: general economic and business conditions in India and overseas, our ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currency changes, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global biotechnology and pharmaceuticals industries, increasing competition in and the conditions of the Indian and global biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in the foreign exchange control regulations in India. 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