BMRN — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-06

• On April 27, 2026, we completed the acquisition of Amicus Therapeutics, Inc. (Amicus). The results of operations of Amicus, along with the preliminary estimated fair values of assets acquired and liabilities assumed in the acquisition, have been included in the Condensed Consolidated Financial State…

• A summary of our commercial products, as of June 30, 2026, is provided below:

• POMBILITI + OPFOLDA (cipaglucosidase alfa-atga/miglustat)(2)

• (1) In 2026, we announced that we will no longer market ROCTAVIAN. For additional information related to ROCTAVIAN, see Note 19 - Restructuring to the Consolidated Financial Statements accompanying our Annual Report on Form 10-K for the year ended December 31, 2025.

• (2) We acquired two commercial products, GALAFOLD and POMBILITI + OPFOLDA, in connection with the acquisition of Amicus on April 27, 2026. Refer to Note 2 - Acquisitions to our accompanying Condensed Consolidated Financial Statements for additional information.

Text removed vs the prior filing · source: 10-Q · 2026-05-05

• A summary of our commercial products, as of March 31, 2026, is provided below:

• (1) In 2026, we announced that we will no longer market ROCTAVIAN. For additional information related to ROCTAVIAN, see Note 19 to the Consolidated Financial Statements accompanying our Annual Report on Form 10-K for the year ended December 31, 2025.

• •In April 2026, we completed the acquisition of Amicus Therapeutics, Inc. (Amicus), a publicly traded, global, biotechnology company for $14.50 per share in an all-cash transaction for a total equity value of approximately $4.8 billion. In connection with the acquisition, the Company also repaid in …

• •In April 2026, in connection with the Amicus acquisition, we obtained senior secured term loan facilities for $2.8 billion in aggregate principal and a new $600.0 million senior secured revolving credit facility. Upon entry into the senior secured term loan facilities, the remaining bridge commitme…

• •In April 2026, we submitted its U.S. supplemental new drug application (sNDA) for full approval of VOXZOGO for achondroplasia.

Text added vs the prior filing · source: 10-Q · 2026-08-06

• Our exposure to market risk for changes in interest rates relates primarily to our cash, cash equivalents, investments, and our variable-rate term loans. The interest rate risk related to our variable-rate term loans arises from these bearing interest based on Secured Overnight Financing Rate (SOFR)…

• There were no borrowings under the 2026 Revolving Facility as of June 30, 2026.

Text added vs the prior filing · source: 10-Q · 2026-08-06

• On April 27, 2026, we completed our acquisition of Amicus Therapeutics, Inc. (Amicus), which was accounted for as a business combination using the acquisition method of accounting. The results of operations of the acquired Amicus business have been included in our results of operations since April 2…

Text added vs the prior filing · source: 10-Q · 2026-08-06

• we may not successfully commercialize any product candidate for which we obtain marketing approval or continue to market any product that has already been commercialized.

• The success of the Amicus Acquisition will depend, in part, on our ability to realize the anticipated benefits from successfully combining our and Amicus’ businesses. We have and plan to continue to devote substantial management attention and resources to integrating our and Amicus’ businesses so th…

• •the inability to successfully commercialize and continue the commercial growth of GALAFOLD and POMBILITI + OPFOLDA;

• company, including key financial metrics and prospects. If we are unable to accurately forecast and meet our financial guidance, our stock price can be materially adversely affected.

• in early clinical trials may not be repeated in later clinical trials. Accordingly, there are no assurances that we will obtain regulatory approval for any of our product candidates. Furthermore, there can be no assurance that approval of one of our product candidates by one regulatory authority wil…

Text removed vs the prior filing · source: 10-Q · 2026-05-05

• The success of the Amicus Acquisition will depend, in part, on our ability to realize the anticipated benefits from successfully combining our and Amicus’ businesses. We plan on devoting substantial management attention and resources to integrating our and Amicus’ businesses so that we can fully rea…

• integration process may be disruptive to our and Amicus’ businesses, and, if implemented ineffectively, could restrict realization of the expected benefits of the Amicus Acquisition. In addition, the acquired Amicus business, including GALAFOLD and POMBILITI + OPFOLDA, may not be successful, may req…

• We have had fewer interactions with regulatory authorities outside the U.S. and the EU as compared to our interactions with the FDA, the EC and the EMA. The approval procedures vary among countries and can involve additional clinical testing, and the time required to obtain approval may differ from …

• compliance. Failure of third-party companies to assist in the approval process or to maintain their own regulatory compliance could delay or prevent approval of our product candidates, or limit our ability to sell a product once it is approved.

• Moreover, promotional communications with respect to drugs, including biologics, are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the product’s approved labeling and Summary of Product Characteristics. In particular, a product may not be pr…

Text added vs the prior filing · source: 10-Q · 2026-08-06

• On April 27, 2026, we committed to a restructuring plan related to the integration of Amicus. This restructuring plan is intended to realize certain targeted synergies following the acquisition, primarily through reductions in overlapping personnel costs within the general and administrative functio…