BioMarin (NASDAQ: BMRN) commits $275M to potential first oral HPP treatment
Rhea-AI Filing Summary
BioMarin Pharmaceutical Inc. is entering into a definitive agreement to acquire Alesta Therapeutics B.V. via a share purchase transaction on a cash‑free, debt‑free basis. Alesta shareholders will receive an upfront cash payment of $275 million, plus up to $215 million in additional payments tied to development and regulatory milestones. Closing is targeted for the third quarter of 2026, subject to customary conditions, including a pre‑closing spinout of Alesta’s non‑ALE1 assets into a separate entity and the absence of legal orders blocking completion.
The acquisition gives BioMarin rights to ALE1, an orally active small molecule in an ongoing Phase 1/2a trial for hypophosphatasia (HPP), a rare genetic bone disease. ALE1 is positioned as a potential first oral therapy targeting the disease‑central metabolite PPi. BioMarin plans to fund the deal with cash on hand and expects the transaction, excluding the upfront consideration, to be modestly dilutive to 2026 financial results. Following closing, ALE1 will join BioMarin’s Skeletal Conditions Business Unit, supporting its strategy to expand into larger rare disease markets.
Positive
- None.
Negative
- Excluding the upfront consideration, the acquisition is expected to be modestly dilutive to 2026 financial results.
Filing Explained
The August 17 share-purchase agreement is signed but not closed: before completion, Alesta must move all non-ALE1 assets and businesses to SpinCo, and its employees will move there, limiting BioMarin’s acquired operating perimeter to ALE1 after that separation.
8-K Event Classification
Key Figures
Key Terms
cash-free, debt-free basis financial
development and regulatory milestones financial
hypophosphatasia (HPP) medical
inorganic pyrophosphate (PPi) medical
Phase 1/2a clinical trial medical
FAQ
What acquisition did BioMarin (BMRN) announce involving Alesta Therapeutics?
How much is BioMarin (BMRN) paying to acquire Alesta Therapeutics?
When is the BioMarin (BMRN) acquisition of Alesta expected to close?
What is ALE1, the asset BioMarin (BMRN) is acquiring from Alesta?
How will the Alesta acquisition affect BioMarin’s (BMRN) financial results?
Will Alesta employees join BioMarin (BMRN) after the acquisition closes?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 OR 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 18, 2026 (
(Exact name of registrant as specified in its charter)
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 1.01 | Entry into a Material Definitive Agreement. |
On August 17, 2026, BioMarin Pharmaceutical Inc., a Delaware corporation (“BioMarin”), entered into a Share Purchase Agreement (the “Purchase Agreement”) with (i) Alesta Therapeutics B.V., a Dutch private limited liability company (besloten vennootschap met beperkte aansprakelijkheid) (the “Company” or “Alesta”), (ii) each of the holders of shares of Alesta identified on Schedule 1.1(a) to the Purchase Agreement, (iii) Anaheim SpinCo B.V., a Dutch private limited liability company (besloten vennootschap met beperkte aansprakelijkheid) (“SpinCo”), and (iv) Shareholder Representative Services LLC, solely in its capacity as the representative and attorney-in-fact of the Company Participating Equityholders (as defined in the Purchase Agreement). Capitalized terms used but not otherwise defined herein have the meanings set forth in the Purchase Agreement.
Pursuant to the Purchase Agreement, BioMarin has agreed to acquire Alesta via a share purchase transaction (the “Share Purchase”) on a cash-free, debt-free basis for (a) an upfront cash amount of $275 million, subject to a customary post-closing purchase price adjustment; and (b) up to $215 million of future payments, subject to the achievement of various development milestones. Alesta, a private company headquartered in the Netherlands, develops novel oral small molecule therapies for underserved rare diseases.
The Share Purchase is expected to be completed in the third quarter of the calendar year 2026 and is subject to certain closing conditions, including (x) the absence of any temporary restraining order, injunction or other legal order, which would have the effect of making illegal or otherwise prohibiting the completion of the Share Purchase, (y) completion of a pre-closing transfer of certain of Alesta’s assets and businesses to SpinCo, and (z) other customary conditions specified in the Purchase Agreement.
The Purchase Agreement contains certain representations, warranties, agreements and covenants of BioMarin and Alesta, including customary operating restrictions on the conduct of the business of Alesta and cooperation provisions that apply until the completion of the Share Purchase or termination of the Purchase Agreement.
The Purchase Agreement also contains customary termination rights for each of BioMarin and Alesta.
The foregoing summary of the Purchase Agreement is subject to, and qualified in its entirety by, the text of the Purchase Agreement, which is filed as Exhibit 2.1 hereto and incorporated herein by reference.
The representations, warranties and covenants set forth in the Purchase Agreement have been made only for the purposes of the Purchase Agreement and solely for the benefit of the parties to the Purchase Agreement, may be subject to limitations agreed upon by the contracting parties, including being qualified by confidential disclosures made for the purposes of allocating contractual risk between the parties to the Purchase Agreement instead of establishing these matters as facts, and may be subject to standards of materiality applicable to the contracting parties that differ from those applicable to investors. In addition, such representations and warranties (1) may not survive the completion of the Share Purchase and, therefore, could not be the basis for any claims under the Purchase Agreement by the other parties after termination of the Purchase Agreement, and (2) were made only as of the dates specified in the Purchase Agreement. Accordingly, investors should not rely on the representations, warranties and covenants or any description thereof as characterizations of the actual state of facts or condition of BioMarin, Alesta or any of their respective subsidiaries, affiliates or businesses.
| Item 7.01 | Regulation FD Disclosure. |
On August 18, 2026, BioMarin issued a press release announcing the execution of the Purchase Agreement. A copy of the press release is attached as Exhibit 99.1 hereto and is incorporated herein by reference.
The information contained in this Item 7.01 of this report, including Exhibit 99.1 attached hereto, is furnished pursuant to Item 7.01 of Form 8-K and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or subject to the liabilities of that section. The information shall not be deemed incorporated by reference into any other filing with the SEC made by BioMarin regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit Number |
Description | |
| 2.1* | Share Purchase Agreement, dated as of August 17, 2026, by and among BioMarin Pharmaceutical Inc., Alesta Therapeutics B.V., each holder of shares of Alesta Therapeutics B.V. identified on Schedule 1.1(a) thereto, Anaheim SpinCo B.V. and Shareholder Representative Services LLC, solely in its capacity as the representative and attorney-in-fact of the Company Participating Equityholders | |
| 99.1 | Press Release issued by BioMarin Pharmaceutical Inc. on August 18, 2026 | |
| 104 | Cover Page Interactive Data File - the cover page XBRL tags are embedded within the Inline XBRL document. | |
| * | Certain exhibits and schedules have been omitted pursuant to Item 601(a)(5) of Regulation S-K. BioMarin agrees to furnish supplementally a copy of any omitted exhibit or schedule to the SEC upon request; provided, however, that BioMarin may request confidential treatment pursuant to Rule 24b-2 of the Exchange Act for any schedule so furnished. |
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements about, among other things, the proposed acquisition of Alesta by BioMarin and the business prospects of Alesta and BioMarin, including, without limitation, statements about: the anticipated occurrence, manner and timing of the closing of the proposed acquisition; expectations regarding Alesta’s product candidates and their ongoing development; the potential impact of the acquisition on BioMarin’s financial results and financial guidance; BioMarin’s plans for external innovation, including BioMarin’s ability to execute additional transactions in future quarters; statements about BioMarin’s future financial performance; and other statements that are not historical facts. Actual results could differ materially from those anticipated in these forward-looking statements. Except as required by law, BioMarin assumes no obligation to update these forward-looking statements, whether as a result of new information, future events or otherwise. These statements, which represent BioMarin’s current expectations or beliefs concerning various future events that are subject to significant risks and uncertainties, may contain words such as “may,” “will,” “would,” “could,” “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “project,” “seek,” “should,” “strategy,” “future,” “opportunity,” “potential” or other similar words and expressions indicating future results.
These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. Forward-looking statements reflect current beliefs and expectations; however, these statements involve inherent risks and uncertainties, including, without limitation, with respect to: consummating the proposed acquisition in the anticipated timeframe, if at all; the possibility that various closing
conditions for the transaction may not be satisfied or waived; the difficulty of predicting the timing or outcome of regulatory approvals or actions, if any; the effects of the proposed acquisition (or the announcement thereof) on BioMarin’s stock price and/or BioMarin’s operating results; unknown or inestimable liabilities; the development, launch and commercialization of products and product candidates; the parties’ ability to realize the anticipated benefits of the proposed acquisition, including the possibility that the expected benefits from the proposed acquisition will not be realized or will not be realized within the expected time period and that BioMarin and Alesta will not be integrated successfully or that such integration may be more difficult, time-consuming or costly than expected; obtaining and maintaining adequate coverage and reimbursement for BioMarin’s or Alesta’s products; the time-consuming and uncertain regulatory approval process; the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success, including risks related to failure or delays in successfully initiating or completing clinical trials and assessing patients, including with respect to current and planned future clinical trials; global economic, financial and healthcare system disruptions and the current and potential future negative impacts to BioMarin’s or Alesta’s business operations and financial results; the sufficiency of BioMarin’s or Alesta’s cash flows and capital resources; BioMarin’s ability to fund the acquisition; BioMarin’s evaluation of the potential impact of the transaction on its financial results and financial guidance; BioMarin’s or Alesta’s ability to achieve targeted or expected future financial performance and results and the uncertainty of future tax, accounting and other provisions and estimates; the effects of the transaction on relationships with key third parties, including employees, customers, suppliers, other business partners or governmental entities, including the risk that the proposed acquisition adversely affects employee retention; transaction costs; risks that the proposed acquisition disrupts current plans and operations; risks that the proposed transaction diverts management’s attention from ongoing business operations; changes in Alesta’s business during the period between announcement and closing of the proposed acquisition; any legal proceedings and/or regulatory actions that may be instituted related to the proposed acquisition; and other risks and uncertainties affecting BioMarin and Alesta, including those risk factors detailed in BioMarin’s filings with the SEC, including, without limitation, the risk factors contained under the caption “Risk Factors” in BioMarin’s Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2026, as such risk factors may be updated by any subsequent reports. Stockholders of BioMarin are urged not to place undue reliance on forward-looking statements, which speak only as of the date hereof. BioMarin is under no obligation, and expressly disclaims any obligation, to update (publicly or otherwise) or alter any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events or otherwise.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| BioMarin Pharmaceutical Inc., a Delaware corporation | ||||||
| Date: August 18, 2026 | By: | /s/ G. Eric Davis | ||||
| G. Eric Davis | ||||||
| Executive Vice President, Chief Legal Officer | ||||||
Exhibit 99.1
Contacts:
| Investors Traci McCarty BioMarin Pharmaceutical Inc. (415) 455-7558 |
Media Erin Rau BioMarin Pharmaceutical Inc. (925) 683-9622 |
BioMarin to Acquire Alesta Therapeutics to Gain ALE1, a Potential First Oral Therapy for Hypophosphatasia, Adding an Important Clinical Program to BioMarin’s Pipeline
BioMarin to pay $275 million upfront, plus additional payments upon achievement of development and regulatory milestones
Alesta to spin out all non-ALE1 assets to a new entity and Alesta employees to transfer to the spinout entity prior to close
ALE1 has significant potential to help BioMarin expand into larger rare disease markets with a medicine intended to address a high unmet need for patients and offers strong strategic fit for the company
SAN RAFAEL, Calif., August 18, 2026 /PRNewswire/ — BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced today that BioMarin has entered into a definitive agreement to acquire Alesta Therapeutics to gain Alesta’s lead clinical-stage asset, ALE1. Alesta plans to spin out all non-ALE1 assets prior to the close of the transaction, which has been approved by the boards of directors of both companies and is expected to be completed this quarter, subject to customary closing conditions.
ALE1 is an orally active, small molecule for the potential treatment of hypophosphatasia (HPP), a rare genetic bone disease caused by mutations in the ALPL gene. ALE1 has the potential to be the first oral therapy for HPP and is currently being evaluated in an ongoing Phase 1/2a clinical trial assessing safety, tolerability and pharmacokinetics/pharmacodynamics in healthy volunteers and adults with HPP.
HPP is a serious condition that can affect bone and tooth mineralization, resulting in easy or frequent bone breaks, early tooth loss, and, in adults, clinically significant muscle weakness, fatigue and pain. If approved, ALE1 is expected to be the first oral therapy approach that targets the central disease metabolite, PPi (inorganic pyrophosphate), with the potential to impact both skeletal and broader manifestations of HPP through systemic correction of disease biology. The program will become part of BioMarin’s Skeletal Conditions Business Unit following close.
“ALE1 is a strong strategic fit for BioMarin, bringing a potential oral alternative to the injectable therapies available today for people living with HPP around the world while meaningfully strengthening our early-stage clinical pipeline,” said Alexander Hardy, President and Chief Executive Officer of BioMarin. “This is exactly the kind of opportunity to address a significant unmet need that lets us compete in larger rare disease markets – adding an asset that has the potential to reach our largest addressable patient population. We plan to continue to seek these kinds of opportunities as we focus on clinical-stage innovation to drive durable growth for BioMarin.”
Under the terms of the agreement, BioMarin will acquire Alesta and Alesta shareholders will receive an upfront payment of $275 million plus up to $215 million in subsequent payments upon achievement of certain development and regulatory milestones. Additionally, immediately prior to the close of BioMarin’s acquisition of Alesta, Alesta will spin out all non-ALE1 assets to a new entity and former Alesta employees will transfer to the spinout entity. As a result, no Alesta employees will become employees of BioMarin in connection with the transaction. BioMarin intends to fund the transaction with cash on hand. BioMarin expects to provide updated full-year 2026 guidance reflecting the acquisition of Alesta following the closing of the transaction. Excluding the upfront consideration, the transaction is expected to have a modestly dilutive impact on 2026 financial results.
“We chose to partner with BioMarin due to their deep commitment to people living with rare diseases,” said Ilan Ganot, Chief Executive Officer of Alesta Therapeutics. “BioMarin’s global reach, scale, and proven expertise in rare disease drug development make it an ideal partner to advance ALE1 and realize its potential as a promising treatment for patients with HPP worldwide. This acquisition is also a testament to the extraordinary work, scientific expertise, and drug development capabilities of the Alesta team.”
Morgan Stanley & Co. LLC is acting as the exclusive financial advisor to BioMarin, and Jones Day is serving as legal counsel in connection with the acquisition. J.P. Morgan Securities LLC is acting as exclusive financial advisor to Alesta, and Goodwin Procter LLP and NautaDutilh N.V. are serving as legal counsel.
About ALE1
ALE1 is designed to inhibit a novel target that regulates levels of inorganic pyrophosphate (PPi), the metabolite at the center of HPP pathology. By lowering excess PPi, ALE1 aims to restore healthier bone and mineral metabolism across the full spectrum of HPP.
More than 9,000 people have been diagnosed with HPP in the U.S., however, the disease is often underdiagnosed due to a broad spectrum of symptoms that can mimic more common conditions.
About BioMarin
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 nine 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 Alesta Therapeutics
Alesta Therapeutics is a clinical-stage biotechnology company committed to developing novel oral small-molecule therapies for underserved diseases. The company’s lead asset, ALE1, is being developed for hypophosphatasia (HPP), a rare genetic disorder with significant unmet need.
For more information, visit www.alestatherapeutics.com.
Forward-Looking Statements
This press release contains forward-looking statements about, among other things, the proposed acquisition of ALE1, the lead clinical-stage asset, of Alesta Therapeutics (Alesta) by BioMarin Pharmaceutical Inc. (BioMarin) and the business prospects of BioMarin, including, without limitation, statements about: the anticipated occurrence, manner, funding and timing of the closing of the proposed acquisition; BioMarin’s plans to update financial guidance; the potential impact of the acquisition on BioMarin’s financial results and financial guidance; the prospective benefits of the proposed acquisition, including expectations that it will be a strong strategic fit for BioMarin and will meaningfully strengthen BioMarin’s early-stage clinical pipeline; expectations regarding ALE1 and its ongoing development, including its potential to be a first-in-class oral therapy for the treatment of hypophosphatasia (HPP) and the potential benefits of ALE1 to patients with HPP around the world; BioMarin’s plans to drive durable growth and strengthen its pipeline for the future; BioMarin’s ability to compete in larger rare disease markets; BioMarin’s expectations regarding unmet need and opportunities in HPP that may potentially be addressed by ALE1, including BioMarin’s estimates regarding the prevalence of HPP; and other statements that are not historical facts.
These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others: consummating the proposed acquisition in the anticipated timeframe, if at all; Alesta’s ability to complete the contemplated spinout of non-ALE1 assets prior to closing of the proposed acquisition, if at all; the possibility that competing offers or acquisition proposals will be made; the possibility that various closing conditions for the transaction may not be satisfied or waived, including that a governmental entity may prohibit, delay, or refuse to grant approval for the consummation of the transaction (or only grant approval subject to adverse conditions or limitations); the difficulty of predicting the timing or outcome of regulatory approvals or actions, if any; the effects of the proposed acquisition (or the announcement thereof) on BioMarin’s stock price and/or BioMarin’s operating results; unknown or inestimable liabilities; the development, launch and commercialization of products and product candidates; BioMarin’s ability to realize the anticipated benefits of the proposed acquisition, including the possibility that the expected benefits from the proposed acquisition will not be realized or will not be realized within the expected time period and that integration will not be successful or that such integration may be more difficult, time-consuming or costly than expected; the time-consuming and uncertain regulatory approval process for pharmaceutical product development; the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success, including risks related to failure or delays in successfully initiating or completing clinical trials and assessing patients, including with respect to current and planned future clinical trials; global economic, financial, and healthcare system disruptions and the current and potential future negative impacts to BioMarin’s business operations and financial results; the sufficiency of BioMarin’s cash flows and capital resources; BioMarin’s ability to fund the acquisition; BioMarin’s evaluation of the potential impact of the transaction on its financial results and financial guidance; BioMarin’s ability to achieve targeted or expected future financial performance and results and the uncertainty of future tax, accounting and other provisions and estimates; the effects of the transaction on relationships with key third parties, including employees, customers, suppliers, other business partners or governmental entities; transaction costs; risks that the proposed acquisition disrupts current plans and operations; risks that the proposed transaction diverts management’s attention from ongoing business operations; changes in Alesta’s business during the period between announcement and closing of the proposed acquisition; any legal proceedings and/or regulatory actions that may be instituted related to the proposed acquisition; and those factors detailed in BioMarin’s filings with the Securities and Exchange Commission, including, without limitation, the factors contained under the caption “Risk Factors” in BioMarin’s Quarterly Report on Form 10-Q for the quarter
ended June 30, 2026, as such factors may be updated by any subsequent reports. Investors are urged not to place undue reliance on forward-looking statements, which speak only as of the date hereof. BioMarin is under no obligation, and expressly disclaims any obligation to update or alter any forward-looking statement, whether as a result of new information, future events or otherwise.
BioMarin® is a registered trademark of BioMarin Pharmaceutical Inc.