8-K
Biomarin Pharmaceutical Inc (BMRN)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 14, 2022
BioMarin Pharmaceutical Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 000-26727 | 68-0397820 | |
|---|---|---|---|
| (State or other jurisdiction of incorporation or organization) | (Commission File Number) | (I.R.S. Employer Identification No.) | |
| 770 Lindaro Street | San Rafael | California | 94901 |
| (Address of Principal Executive Offices) | (Zip Code) |
(415) 505-6700
(Registrant's telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report.)
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)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Stock, par value $0.001 | BMRN | The Nasdaq Global Select Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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. ☐
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Item 1.01 Entry Into a Material Definitive Agreement.
On February 8, 2022, BioMarin Pharmaceutical Inc., a Delaware corporation (BioMarin), and BioMarin International Ltd., a private limited liability company registered in Ireland and wholly owned subsidiary of BioMarin (together with BioMarin, the Company), entered into a definitive agreement (the Asset Purchase Agreement) to sell a Rare Pediatric Disease Priority Review Voucher (PRV) for a lump sum payment of $110,000,000. The Company received the PRV under a United States Food and Drug Administration (FDA) program intended to encourage the development of treatments for rare pediatric diseases. BioMarin was awarded the PRV in November 2021 when the FDA granted accelerated approval to VOXZOGO™ (vosoritide) for injection, indicated to increase linear growth in pediatric patients with achondroplasia five years of age and older with open epiphyses (growth plates).
The transactions contemplated by the Asset Purchase Agreement remain subject to customary closing conditions, including the expiration or termination of the required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. The Agreement contains customary representations, warranties and covenants.
The foregoing description of the Asset Purchase Agreement does not purport to be complete and is qualified in its entirety by reference to the complete text of the Asset Purchase Agreement, which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ending March 31, 2022.
Item 7.01 Regulation FD Disclosure.
On February 9, 2022, the Company issued a press release pursuant to which it announced that it had entered into the Asset Purchase Agreement. A copy of the press release is furnished as Exhibit 99.1 hereto. The press release is not incorporated by reference in this Current Report on Form 8-K.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit Number | Description |
|---|---|
| 99.1 | Press Release of the Company dated February 9, 2022 |
| 104 | Cover Page Interactive Data File - the cover page XBRL tags are embedded within the Inline XBRL document. |
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements, including, but not limited to, statements about the closing of the transactions contemplated by the Asset Purchase Agreement and the Company’s receipt of the payment for the PRV. These forward-looking statements are predictions and involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to anti-trust review of the Asset Purchase Agreement and those factors detailed in the Company’s filings with the Securities and Exchange Commission, including, without limitation, the factors contained under the caption “Risk Factors” and elsewhere in the Company’s Securities and Exchange Commission (SEC) filings and reports (Commission File No. 000-26727), including the Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 filed with the SEC on October 29, 2021, and future filings and reports by the Company. The Company undertakes no duty or obligation to update any forward-looking statements contained in this Current Report on Form 8-K as a result of new information, future events or changes in its expectations.
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., <br>a Delaware corporation | ||
|---|---|---|
| Date: February 14, 2022 | By: | /s/ G. Eric Davis |
| G. Eric Davis | ||
| Executive Vice President, General Counsel |
Document
Exhibit 99.1
BioMarin Sells Priority Review Voucher for $110 Million
SAN RAFAEL, Calif., Feb. 9, 2022—SAN RAFAEL, Calif.,—BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced that it has entered into a definitive agreement with an undisclosed purchaser to sell the Rare Pediatric Disease Priority Review Voucher (PRV) it obtained in November 2021 for a lump sum payment of $110,000,000. The Company received the voucher under a Food and Drug Administration (FDA) program intended to encourage the development of treatments for rare pediatric diseases. BioMarin was awarded the voucher when it received approval of VOXZOGO™ (vosoritide) for Injection, indicated to increase linear growth in pediatric patients with achondroplasia five years of age and older with open epiphyses (growth plates). The transaction remains subject to customary closing conditions, including anti-trust review.
"We are pleased to announce the sale of the PRV and plan to direct the proceeds from this voucher sale towards additional investment in an already robust pipeline of investigational therapies for people with genetic diseases,” said Jean-Jacques Bienaimé, Chief Executive Officer of BioMarin. "We are proud to be able to participate in this program and that this voucher will be accelerating the availability of a therapy for patients.”
This is the third Priority Review Voucher that BioMarin has received. The FDA also awarded PRVs to the company when Brineura® (cerliponase alfa) and Vimizim® (elosulfase alfa) were approved. Company Management expects that the net gain on the sale of the PRV, after income taxes, will be incremental to the Company’s previously communicated expectation to earn positive GAAP net income in 2022.
About the Rare Pediatric Disease Priority Review Voucher Program
The program is intended to encourage development of new drug and biological products for the prevention and treatment of certain rare pediatric diseases. A PRV is issued to the sponsor of a rare pediatric disease product application and entitles the holder to priority review of a single New Drug Application or Biologics License Application. The sponsor receives the voucher upon approval of the rare pediatric disease product application. PRVs may be sold or transferred, and there is no limit on the number of times a PRV can be transferred.
About FDA Standard Review and Priority Review Designations
Prior to approval, each drug marketed in the United States must go through a detailed FDA review process. In 1992, under the Prescription Drug User Act (PDUFA), FDA agreed to specific goals for improving the drug review time and created a two-tiered system of review times - Standard Review and Priority Review. A Priority Review designation is given to drugs that provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition. The FDA goal for reviewing a drug with Priority Review status is six months from the time the application is filed by the FDA, compared to 10 months under standard review.
About BioMarin
BioMarin is a global biotechnology company that develops and commercializes innovative therapies for people with serious and life-threatening rare disorders. The company's portfolio consists of seven commercialized products and multiple clinical and pre-clinical product candidates.
For additional information, please visit www.BMRN.com. Information on BioMarin's website is not incorporated by reference into this press release.
Forward-Looking Statements
This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc., including, without limitation, statements about: the Company’s plans to use the PRV sale proceeds towards additional investment in BioMarin’s development programs and
expectations that the net gain on the sale of the PRV, after income taxes, will be incremental to the Company’s previously communicated expectation to earn positive GAAP net income in 2022. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. Additional important factors to be considered in connection with forward-looking statements are detailed from time to time under the caption "Risk Factors" and elsewhere in BioMarin's Securities and Exchange Commission (SEC) filings, including BioMarin's Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, and future filings and reports by BioMarin. BioMarin undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information, future events or changes in its expectations.
BioMarin®, Brineura® and VIMIZIM® are registered trademarks of BioMarin Pharmaceutical Inc. or its affiliates. VOXZOGO™ is a trademark of BioMarin Pharmaceutical Inc. or its affiliates.
Contact:
Investors: Media:
Traci McCarty Debra Charlesworth
BioMarin Pharmaceutical Inc. BioMarin Pharmaceutical Inc.
(415) 455-7558 (415) 455-7451