Full Press Release Details
| BioMarin Contacts | Amicus Contacts | |||
| Traci McCarty, Investors BioMarin Pharmaceutical Inc. (415) 455-7558 | Andrew Faughnan, Investors Amicus Therapeutics (609) 662-3809 | |||
| Marni Kottle, Media BioMarin Pharmaceutical Inc. (415) 218-7111 | Brendan McEvoy, Media Amicus Therapeutics (202) 320-7767 |
BioMarin to Acquire Amicus Therapeutics for $4.8 Billion, Expanding Position as a Leader in Rare Diseases, Accelerating Revenue Growth and
Strengthening Financial Outlook
BioMarin to Gain Galafold (migalastat) for Fabry Disease and Pombiliti (cipaglucosidase alfa-atga) + Opfolda (miglustat) for Pompe Disease, Adding Two Marketed, High-Growth Products with $599 Million in
Revenue Over Past Four Quarters
Provides Opportunity to Expand Access to Galafold and Pombiliti + Opfolda to Patients in New
Markets Across BioMarin's Global Footprint; Pending U.S. Galafold Patent Litigation Resolved
Will Accelerate Revenue Growth
Immediately After Close; Expected to be Accretive to Non-GAAP Diluted Earnings Per Share (EPS) in the First 12 Months Post-Close and Substantially Accretive to Non-GAAP
Diluted EPS Beginning in 2027
Conference Call Today at 8:15 a.m. Eastern Time
SAN RAFAEL, Calif., and PRINCETON, N.J., Dec. 19, 2025 /PRNewswire/ - BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) and Amicus Therapeutics
(Nasdaq: FOLD) announced today that BioMarin has entered into a definitive agreement to acquire Amicus for $14.50 per share in an all-cash transaction for a total equity value of approximately
$4.8 billion. The agreement has been unanimously approved by the Boards of Directors of both companies and Amicus' Board of Directors unanimously recommended that Amicus' stockholders vote to adopt the agreement. The transaction is
expected to close in the second quarter of 2026, subject to regulatory clearances, approval by the stockholders of Amicus and other customary closing conditions.
"Amicus, like BioMarin, is a company that has been profoundly dedicated to transforming care for
patients with rare diseases since its founding, developing and bringing to market important therapies for individuals living with Fabry disease and Pompe disease. BioMarin's scale of operations, including our global commercial footprint and
industry-leading, in-house manufacturing capabilities make the combination of these companies an exceptional strategic fit," said Alexander Hardy, President and Chief Executive Officer of BioMarin.
"Immediately upon close, this transaction is expected to accelerate BioMarin's revenue growth and strengthen our financial outlook, delivering significant value to patients, employees and stockholders. The transaction is expected to be
accretive to Non-GAAP Diluted EPS in the first 12 months following close."
"I am enormously proud of
our Amicus team. Together with our partners in the rare disease community, we created a truly patient-centric biotech and successfully developed two transformative medicines for people living with rare diseases, which impacted the lives of more than
3,400 patients around the world," said Bradley L. Campbell, President and Chief Executive Officer of Amicus. "With BioMarin's unwavering commitment to patients, along with greater resources and scale, Amicus' medicines will
reach even more patients around the world, faster. We are confident that this agreement is in the best interests of our shareholders by providing compelling, certain and premium value, and will accelerate progress for the rare disease
Transaction Will Expand and Diversify BioMarin's Rare Disease Product Portfolio
The acquisition will strengthen BioMarin's commercial portfolio, adding two new treatments to the company's existing portfolio of medicines that
target lysosomal storage disorders: Galafold (migalastat), the first oral treatment for Fabry disease, and Pombiliti (cipaglucosidase
alfa-atga) + Opfolda (miglustat), a two-component therapy for Pompe disease. Amicus also has U.S. rights to
DMX-200, a potential first-in-class investigational small molecule for the treatment of focal segmental glomerulosclerosis
(FSGS), a rare and fatal kidney disease in Phase 3 development. The transaction is expected to:
Under the terms of the
agreement, BioMarin will acquire Amicus for $14.50 per share in an all-cash transaction, representing a 33% premium to Amicus' last close, a 46% premium to the
30-day volume-weighted average stock price and a 58% premium to the 60-day volume-weighted average stock price.
The consummation of the transaction is subject to customary closing conditions, including approval by the stockholders of Amicus, the expiration or
termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and other antitrust authority clearances, and other customary conditions. Following the satisfaction of the closing conditions to the proposed
transaction, a wholly owned subsidiary of BioMarin will merge with Amicus and the outstanding Amicus shares will be converted into the right to receive $14.50 per share in cash, without interest and subject to any withholding of taxes.
The transaction is not subject to
financing conditions. BioMarin intends to finance the transaction through a combination of cash on hand and approximately $3.7 billion of non-convertible debt financing. Morgan Stanley Senior Funding,
Inc. is acting as sole lead arranger and has provided a bridge commitment for this amount. The permanent financing structure will include a meaningful portion of pre-payable debt, in line with
BioMarin's commitment to deleveraging with a target of gross leverage of <2.5x within two years after the closing of the proposed transaction.
Pending U.S. Galafold IP Litigation Resolved
Separately, Amicus has resolved the patent litigation it brought in response to Aurobindo Pharma's and Lupin Ltd.'s Abbreviated New Drug
Applications seeking approval to market a generic version of Galafold 123 mg capsules prior to expiration of the certain Amicus patents. In connection with the resolution of the patent litigation, Amicus entered into License Agreements with
Aurobindo and Lupin for Galafold 123 mg capsules. Pursuant to the terms of the agreements, Amicus will grant Aurobindo and Lupin licenses to market generic versions of Galafold in the United States beginning on January 30, 2037, if
approved by the U.S. Food and Drug Administration (FDA) and unless certain limited circumstances customarily included in these types of agreements occur. As required by law, the companies will submit the confidential license agreements to the U.S.
Federal Trade Commission and the U.S. Department of Justice for review. In accordance with the agreements, the parties will terminate all ongoing Hatch-Waxman litigation between Amicus and Aurobindo and Lupin regarding Galafold patents pending
in the U.S. District Court for the District of Delaware.
Morgan Stanley & Co. LLC acted as the lead financial advisor to BioMarin and J.P. Morgan Securities, LLC also provided financial advice to BioMarin;
Jones Day is serving as legal counsel to BioMarin in connection with the acquisition and Cooley LLP is serving as legal counsel to BioMarin in connection with the financing. Centerview Partners LLC and Goldman Sachs & Co. LLC are acting as
financial advisors to Amicus, and Kirkland & Ellis LLP is serving as legal counsel to Amicus.
BioMarin will host a conference call and webcast to discuss the acquisition today, Dec. 19, at 8:15 a.m. ET. This event can be accessed through this link or on
the investor section of the BioMarin website at www.biomarin.com.
| U.S./Canada Dial-in Number: 800-715-9871 | Replay Dial-in Number: 800-770-2030 | |
| International Dial-in Number: 646-307-1963 | Replay International Dial-in Number: 609-800-9909 | |
| Conference ID: 7225321 | Conference ID: 7225321 |
Galafold (migalastat) 123 mg capsules is an oral pharmacological chaperone of alpha-Galactosidase A (alpha-Gal A) for the treatment of Fabry disease in adults who have amenable galactosidase alpha gene (GLA) variants. In these patients, Galafold works by stabilizing the body's own dysfunctional enzyme so
that it can clear the accumulation of disease substrate. Globally, Amicus Therapeutics estimates that approximately 35 to 50 percent of people living with Fabry disease may have amenable GLA variants, though amenability rates within this range
vary by geography. Galafold is approved in more than 40 countries around the world, including the U.S., EU, U.K., and Japan.
U.S. INDICATIONS AND
Galafold is indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA)
variant based on in vitro assay data.
This indication is approved under accelerated approval based on reduction in kidney interstitial capillary cell
globotriaosylceramide (KIC GL-3) substrate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
U.S. IMPORTANT SAFETY INFORMATION
REACTIONS: The most common adverse reactions reported with Galafold ( 10%) were headache, nasopharyngitis, urinary tract infection, nausea and pyrexia. USE IN SPECIFIC POPULATIONS: There is insufficient clinical data on Galafold use
in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Advise women of the potential risk to a fetus. It is not known if Galafold is present in human milk. Therefore, the developmental and health benefits of
breastfeeding should be considered along with the mother's clinical need for Galafold and any potential adverse effects on the breastfed child from Galafold or from the underlying maternal condition. Galafold is not recommended for use in
patients with severe renal impairment or end-stage renal disease requiring dialysis. The safety and effectiveness of Galafold have not been established in pediatric patients. To report Suspected Adverse
Reactions, contact Amicus Therapeutics at 1-877-4AMICUS or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch. For additional information about Galafold, including the full U.S.
Prescribing Information, please visit https://www.amicusrx.com/pi/Galafold.pdf.
About Pombiliti + Opfolda
Pombiliti + Opfolda, is a two-component therapy that consists of cipaglucosidase alfa-atga, a bis-M6P-enriched rhGAA that facilitates high-affinity uptake through the M6P receptor while retaining its capacity for processing into the most active form of the enzyme, and
the oral enzyme stabilizer, miglustat, that's designed to reduce loss of enzyme activity in the blood.
U.S. INDICATIONS AND USAGE
POMBILITI in combination with OPFOLDA is indicated for the treatment of adult patients with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA]
deficiency) weighing 40 kg and who are not improving on their current enzyme replacement therapy (ERT).
HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS: Appropriate medical support measures, including cardiopulmonary resuscitation equipment, should be readily
available. If a severe hypersensitivity reaction occurs, POMBILITI should be discontinued immediately and appropriate medical treatment should be initiated. INFUSION-ASSOCIATED REACTIONS (IARs): If severe IARs occur, immediately discontinue
POMBILITI and initiate appropriate medical treatment. RISK OF ACUTE CARDIORESPIRATORY FAILURE IN SUSCEPTIBLE PATIENTS: Patients susceptible to fluid volume overload, or those with acute underlying respiratory illness or compromised cardiac or
respiratory function, may be at risk of serious exacerbation of their cardiac or respiratory status during POMBILITI infusion. See PI for complete Boxed Warning. CONTRAINDICATION: POMBILITI in combination with Opfolda is contraindicated in
pregnancy. EMBRYO-FETAL TOXICITY: May cause embryo-fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for at least 60 days after the last dose.
Adverse Reactions: Most common adverse reactions 5% are headache, diarrhea, fatigue, nausea, abdominal pain, and pyrexia. Please see full PRESCRIBING INFORMATION, including BOXED WARNING, for POMBILITI (cipaglucosidase alfa-atga)
LINK and full PRESCRIBING INFORMATION for OPFOLDA (miglustat) LINK.
BioMarin is a leading, global rare disease biotechnology company focused on delivering medicines for people living with genetically defined conditions. Founded
in 1997, the San Rafael, California-based company has a proven track record of innovation, with eight commercial therapies and a strong clinical and preclinical pipeline. Using a distinctive approach to drug discovery and development, BioMarin seeks
to unleash the full potential of genetic science by pursuing category-defining medicines that have a profound impact on patients.
To learn more, please visit www.biomarin.com.
About Amicus Therapeutics
Amicus Therapeutics (Nasdaq: FOLD) is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering novel high-quality
medicines for people living with rare diseases. With extraordinary patient focus, Amicus Therapeutics is committed to advancing and expanding a pipeline of cutting-edge, first- or
best-in-class medicines for rare diseases.
To learn more, please visit
the company's website at www.amicusrx.com.
Forward-Looking Non-GAAP Financial Information
BioMarin defines Non-GAAP Diluted EPS as Non-GAAP Income divided
by Non-GAAP Weighted-Average Diluted Shares Outstanding. Non-GAAP Income is defined by BioMarin as GAAP Net Income excluding amortization of intangible assets,
stock-based compensation expense and, in certain periods, certain other specified items. BioMarin defines Non-GAAP Weighted-Average Diluted Shares Outstanding as GAAP Weighted-Average Diluted Shares
Outstanding, adjusted to include any common shares issuable under BioMarin's equity plans and convertible debt in periods when they are dilutive under Non-GAAP. BioMarin has not provided an expectation
regarding the impact to EPS in the first 12 months after close or in 2027 because BioMarin is unable to predict with reasonable certainty the financial impact of changes resulting from its strategic portfolio and business operating model reviews;
potential future asset impairments; gains and losses on investments; and other unusual gains and losses without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results.
Forward-Looking Statements