In addition to the other information set forth in this report, you should carefully consider the risk factors discussed in Part I, Item 1A “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 , which could materially affect our business, financial condition, or results of operations.
−Removed: There has been no material change in the risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, with the exception of the addition of the following risk factors:
−Removed: Adverse global conditions, including economic uncertainty and tariffs, may negatively impact our financial results.
−Removed: Global conditions, dislocations in the financial markets, or inflation could adversely impact our business.
−Removed: In addition, the global macroeconomic environment has been and may continue to be negatively affected by, among other things, instability in global economic markets, increased U.S.
−Removed: trade tariffs and trade disputes with other countries, instability in the global credit markets, supply chain weaknesses, instability in the geopolitical environment, political tensions, and foreign governmental debt concerns.
−Removed: Such challenges have caused, and may continue to cause, uncertainty and instability in local economies and in global financial markets, which may adversely affect our business.
−Removed: Executive actions on drug pricing could negatively impact our ability to obtain adequate reimbursement for our products, if and when they are approved.
−Removed: On April 15, 2025, the Trump Administration published Executive Order 14273, “Lowering Drug Prices by Once Again Putting Americans First,” which generally directs the federal government to take measures to reduce drug prices, including eliminating the so-called “pill penalty” under the Inflation Reduction Act that creates a distinction between small molecule and large molecule products for purposes of determining when a drug may be eligible for drug price negotiation.
−Removed: On May 12, 2025, the Trump Administration published Executive Order 14297, “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” which generally, among other things, directs the federal government to establish and communicate most-favored-nation price targets to pharmaceutical manufacturers to bring prices for American patients in line with comparably developed nations.
−Removed: Further, the Executive Order directs the federal government to support regulatory paths to allow direct-to-patient sales for companies that meet these targets.
−Removed: It also states that the Administration will take additional aggressive action (for example, examining whether marketing approvals should be modified or rescinded or opening the door for individual drug importation waivers) should manufacturers fail to offer American consumers the most-favored-nation lowest price.
−Removed: It also directs the Secretary of Commerce and the U.S.
−Removed: Trade Representative to “take all necessary and appropriate action to ensure foreign countries are not engaged in any act, policy, or practice that may be unreasonable or discriminatory or that may impair United States national security .
−Removed: including by suppressing the price of pharmaceutical products below fair market value in foreign countries.” Notably, a similar “Most Favored Nation” pricing rule enacted under the first Trump Administration was subject to an injunction resulting from judicial challenges to the rule, which was formally rescinded by the former Biden Administration in August 2021.
−Removed: For more information, see the section titled, “Business - Government Regulation - Current and future healthcare reform legislation” in our Annual Report on Form 10-K.
+Added: There has been no material change in the risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025.
Unregistered Sales of Equity Securities and Use of Proceeds.
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