Viatris Announces Exclusive Licensing Agreement with Lexicon Pharmaceuticals for Sotagliflozin in all Markets Outside of the U.S. and Europe

Rhea-AI Summary

Viatris Inc. (Nasdaq: VTRS) has entered an exclusive licensing agreement with Lexicon Pharmaceuticals for sotagliflozin in all markets outside the U.S. and Europe. Sotagliflozin, approved by the FDA in May 2023, reduces cardiovascular risks in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.

This agreement leverages Viatris' expertise in cardiovascular diseases and its Global Healthcare Gateway®. Viatris will pay Lexicon an upfront payment of $25 million, with additional potential contingent payments including regulatory milestones, sales milestones, and tiered royalties ranging from low-double-digit to upper-teens on annual net sales. Viatris will handle regulatory and commercialization activities in licensed territories, while Lexicon will provide clinical and commercial supply of sotagliflozin.

Positive

• Expansion of Viatris' innovative portfolio in cardiovascular diseases
• Potential for accelerated and durable revenue growth
• Leveraging Viatris' global infrastructure and expertise in cardiovascular diseases
• Opportunity to expand sotagliflozin to additional indications

Negative

• Upfront payment of $25 million to be expensed as in-process research and development
• Additional potential contingent payments and royalties to be paid to Lexicon

Insights

Financial Analyst

This licensing agreement represents a strategic move for Viatris to expand its innovative portfolio in cardiovascular diseases. The $25 million upfront payment, while significant, is relatively small compared to Viatris' $14 billion market cap. The real value lies in the potential future revenue from sotagliflozin sales. With tiered royalties ranging from low-double-digit to upper-teens on annual net sales, this deal could become a substantial revenue driver if the drug performs well in markets outside the U.S. and Europe. The agreement aligns with Viatris' strategy to leverage its global infrastructure and expertise to commercialize innovative products. However, investors should note that the immediate financial impact will be an expense for in-process R&D, which may affect short-term earnings.

Medical Research Analyst

Sotagliflozin's FDA approval for reducing cardiovascular risks in adults with heart failure or type 2 diabetes with chronic kidney disease is significant. As a dual SGLT1 and SGLT2 inhibitor, it offers a unique mechanism of action that could provide advantages over existing SGLT2 inhibitors. The potential for additional indications, as mentioned in the agreement, could substantially expand the drug's market opportunity. Viatris' expertise in cardiovascular diseases and global reach could accelerate sotagliflozin's adoption in new markets. However, the success of this deal will depend on the drug's performance in real-world settings and its ability to differentiate from established competitors in the SGLT inhibitor class.

• Continues to Expand Viatris' Innovative Portfolio in Cardiovascular Diseases
• Leverages Viatris' Unique Global Infrastructure and Expertise
• Includes Opportunities to Leverage the Potential of Sotagliflozin to Additional Indications

PITTSBURGH, Oct. 16, 2024 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced it has entered into an exclusive licensing agreement with Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) for sotagliflozin in all markets outside of the United States and Europe.

Sotagliflozin was approved by the U.S. Food and Drug Administration in May 2023 to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.

This licensing agreement leverages Viatris' expertise in cardiovascular diseases and its Global Healthcare Gateway^® — which offers partners ready access to more markets and patients worldwide through the Company's unique global infrastructure and expertise. This transaction is another example of how the Company is continuing to expand its innovative portfolio by identifying, vetting and securing highly innovative, patent-protected assets that address significant unmet medical needs.

Viatris Chief Commercial Officer Corinne Le Goff said: "This licensing agreement with Lexicon adds another asset to our expanding innovative portfolio in cardiovascular diseases which gives us the opportunity to further drive accelerated and durable revenue growth in the future. We believe we will be able to leverage our strong foundation in cardiovascular diseases and our unique infrastructure to execute on the potential of sotagliflozin. We look forward to working with Lexicon to make a real difference and expand access for patients."

Lexicon CEO and Director, Dr. Mike Eaton, Ph.D., said: "We are pleased to be working with Viatris, a company with strong cardiometabolic expertise, global commercial capabilities and a successful track record of launching medicines in new territories. We are confident that this agreement will expand the reach of sotagliflozin to more patients in need. Partnering with high quality companies to support commercialization of our medicines globally is a critical pillar of our Lead to Succeed strategy at Lexicon. We plan to continue to evaluate strategic partnerships for additional assets, territories and indications to augment Lexicon's development and commercial capabilities, advance our pipeline and expand access of our medicines to more patients around the world." 

Terms of the Transaction
Under the terms of the agreement, Viatris will acquire rights to sotagliflozin in all global markets outside of the U.S. and Europe in exchange for an upfront payment to Lexicon of $25 million, and additional potential contingent payments, including regulatory milestones, sales milestones and tiered royalties ranging from low-double-digit to upper-teens on annual net sales. Viatris will be responsible for all regulatory and commercialization activities for sotagliflozin in the licensed territories. Lexicon will be responsible for providing clinical and commercial supply of sotagliflozin to Viatris. Viatris currently expects to account for the transaction as an asset acquisition, with the upfront payment being expensed as in-process research and development.

About Sotagliflozin
Sotagliflozin is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose and sodium reabsorption by the kidney and SGLT1 is responsible for glucose and sodium absorption in the gastrointestinal tract. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients.

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).

About Lexicon Pharmaceuticals
Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients' lives. Through its Genome5000™ program, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. Lexicon is commercially launching one of these medicines, INPEFA® (sotagliflozin) in the United States, and has a pipeline of other promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, diabetes and metabolism and other indications. For additional information, please visit www.lexpharma.com. 

Forward-Looking Statements
This press release includes statements that constitute "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 statements that this continues to expand Viatris' innovative portfolio in cardiovascular diseases; this licensing agreement leverages Viatris' expertise in cardiovascular diseases and its Global Healthcare Gateway^® — which offers partners ready access to more markets and patients worldwide through the Company's unique global infrastructure and expertise; this transaction is another example of how the Company is continuing to expand its innovative portfolio by identifying, vetting and securing highly innovative, patent-protected assets that address significant unmet medical needs; this licensing agreement with Lexicon adds another asset to our expanding innovative portfolio in cardiovascular diseases which gives us the opportunity to further drive accelerated and durable revenue growth in the future; we believe we will be able to leverage our strong foundation in cardiovascular diseases and our unique infrastructure to execute on the potential of sotagliflozin; we look forward to working with Lexicon to make a real difference and expand access for patients; and the terms of the transaction. 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: actions and decisions of healthcare and pharmaceutical regulators; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; any regulatory, legal or other impediments to Viatris' ability to bring new products to market, including but not limited to "at-risk" launches; Viatris' or its partners' ability to develop, manufacture, and commercialize products; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings; the possibility that Viatris may be unable to realize the intended benefits of, or achieve the intended goals or outlooks with respect to, its strategic initiatives; the possibility that Viatris 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; goodwill or impairment charges or other losses related to the divestiture or sale of businesses or assets; Viatris' failure to achieve expected or targeted future financial and operating performance and results; the potential impact of public health outbreaks, epidemics and pandemics; any significant breach of data security or data privacy or disruptions to our information technology systems; risks associated with international operations; the ability to protect intellectual property and preserve intellectual property rights; changes in third-party relationships; the effect of any changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties and matters beyond the control of management, including general economic conditions, inflation and exchange rates; failure to execute stock repurchases consistent with current expectations; stock price volatility; and the other risks described in Viatris' filings with the Securities and Exchange Commission (SEC). Viatris routinely uses its website 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). Viatris undertakes no obligation to update these statements for revisions or changes after the date of this press release other than as required by law.

 

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SOURCE Viatris Inc.

FAQ

What is the exclusive licensing agreement between Viatris and Lexicon Pharmaceuticals for?

Viatris (VTRS) has entered an exclusive licensing agreement with Lexicon Pharmaceuticals for sotagliflozin in all markets outside the United States and Europe.

What is sotagliflozin approved for by the FDA?

Sotagliflozin was approved by the FDA in May 2023 to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.

What are the financial terms of the licensing agreement between Viatris (VTRS) and Lexicon?

Viatris (VTRS) will pay Lexicon an upfront payment of $25 million, with additional potential contingent payments including regulatory milestones, sales milestones, and tiered royalties ranging from low-double-digit to upper-teens on annual net sales.

How does Viatris (VTRS) plan to account for the transaction with Lexicon?

Viatris (VTRS) currently expects to account for the transaction as an asset acquisition, with the upfront payment being expensed as in-process research and development.