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U.S. Department of Justice Informs Viatris That It No Longer Considers Mylan a Subject of Generic Drug Industry Antitrust Investigation

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Viatris (NASDAQ: VTRS) announced that the U.S. Department of Justice (DOJ) no longer considers Mylan, a Viatris subsidiary, and its former President, Rajiv Malik, subjects of an antitrust investigation in the generic drug industry. Additionally, the DOJ's Civil Division will not take further action regarding a civil investigative demand on generic drug pricing and sales. Viatris has consistently maintained that Mylan found no evidence of wrongdoing. The company is now focused on defending itself against remaining civil lawsuits related to these matters. More details are available in Viatris' Quarterly Report on Form 10-Q for the quarter ended March 31, 2024.

Positive
  • The DOJ no longer considers Mylan and its former President, Rajiv Malik, as subjects of an antitrust investigation.
  • The Civil Division of the DOJ will not pursue further actions regarding generic drug pricing and sales.
Negative
  • Viatris still faces remaining civil lawsuits pertaining to these matters.

Insights

The resolution of the DOJ's criminal and civil investigations into Mylan is a noteworthy development. Legal clarity concerning significant regulatory issues often leads to a more stable operational environment for the company. For investors, this reduces the legal overhang that may have previously affected stock performance negatively.

Additionally, the closure of these investigations highlights the robustness of Mylan's compliance and governance frameworks. This outcome may signify a turning point, potentially lowering the company's risk profile and mitigating future regulatory scrutiny. However, the ongoing civil lawsuits still necessitate attention, as their outcomes could have financial ramifications.

Investors should note that while this news is positive, the potential costs and distractions from defending against the remaining lawsuits should not be disregarded. The company's legal expenses and any potential settlements or judgments could impact its financial health in the future.

The DOJ's decision not to pursue further investigations into Mylan removes a significant uncertainty from Viatris’s business landscape. For investors, this signals a potential positive shift in market sentiment. Regulatory uncertainty often leads to stock price volatility and this news could stabilize investor confidence in Viatris.

With regulatory risks subsiding, Viatris can now channel more resources towards growth initiatives and strategic goals without the overhang of potential legal liabilities. However, it's essential for investors to monitor the company's progress in resolving the remaining civil lawsuits and how Viatris plans to handle any financial implications from these litigations.

Furthermore, the positive resolution of these high-profile investigations could enhance Viatris’s reputation, potentially making it a more attractive partner for future collaborations and business ventures within the pharmaceutical industry.

PITTSBURGH, July 2, 2024 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS) today announced that the Antitrust Division of the U.S. Department of Justice ("DOJ") has advised that it no longer considers Mylan, and its former President, Rajiv Malik, a subject of its antitrust investigation in the generic drug industry. The Civil Division of the DOJ has also informed the Company that it does not expect to take any further actions in connection with a civil investigative demand related to the pricing and sales of generic drug products.  

This outcome affirms the Company's longstanding position, which it has consistently maintained and asserted, for many years, that Mylan investigated these allegations thoroughly and found no evidence of wrongdoing on the part of Mylan or its employees. 

The Company is pleased to put these DOJ investigations behind it and will continue to move forward to vigorously defend itself against the remaining civil lawsuits pertaining to these matters. Please refer to Viatris' Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 for more information regarding these drug pricing matters.

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).

Forward-Looking Statements
This statement 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 about the outcome of investigations and litigation and that the Company is pleased to put these DOJ investigations behind it and will continue to move forward to vigorously defend itself against the remaining civil lawsuits pertaining to these matters. 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 statement other than as required by law.

Viatris OUS Logo (PRNewsfoto/Viatris Inc.)

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SOURCE Viatris Inc.

FAQ

What recent announcement did Viatris make about the DOJ investigation?

Viatris announced that the DOJ no longer considers Mylan and its former President, Rajiv Malik, subjects of an antitrust investigation in the generic drug industry.

What is the significance of the DOJ's Civil Division's decision for Viatris?

The DOJ's Civil Division decision not to take further action on the civil investigative demand related to generic drug pricing and sales is significant as it clears Viatris from further legal scrutiny on that front.

How has Viatris responded to the DOJ's decisions?

Viatris is pleased with the DOJ's decisions, affirming their longstanding position of no wrongdoing and is now focused on defending against remaining civil lawsuits.

Where can more information about Viatris' drug pricing matters be found?

More information can be found in Viatris' Quarterly Report on Form 10-Q for the quarter ended March 31, 2024.

Viatris Inc.

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