Item 1.01 Entry into a Material Definitive Agreement.
On July 15, 2022, Ultragenyx Pharmaceutical Inc. (the "Company") entered into a
Unit Purchase Agreement (the "Purchase Agreement") with GeneTx Biotherapeutics
LLC ("GeneTx"), the Unitholders (as defined in the Purchase Agreement) and
Deborah A. Guagliardo, solely in her capacity as a representative of the
Unitholders, pursuant to which the Company purchased all the outstanding units
of GeneTx. The closing of the transaction (the "Closing") contemplated by the
Purchase Agreement occurred on July 15, 2022 and following the Closing, GeneTx
became a wholly owned subsidiary of the Company. The Company and GeneTx
previously entered into a Program Agreement, dated as of August 13, 2019, and a
Unitholder Option Agreement, dated as of August 13, 2019 and subsequently
amended, pursuant to which, respectively, the parties agreed to collaborate on
the development of GTX-102, an antisense oligonucleotide for the treatment of
Angelman syndrome, and pursuant to which the Company received an exclusive
option to acquire GeneTx.
In accordance with the terms of the Purchase Agreement, the Company acquired
GeneTx for a purchase price of $75.0 million in cash, subject to customary
adjustments for working capital and transaction expenses. The Company is also
required to make milestone payments of up to $115.0 million in the aggregate to
the Unitholders based on certain regulatory milestone events, including a
milestone payment in an amount up to $30.0 million upon achievement of the
earlier of a Phase 3 clinical study start and product approvals in Canada and
the U.K, and commercial milestone payments of up to $75.0 million in the
aggregate based on specified worldwide net product sales, if such milestones are
achieved. In addition, the Company is required to pay tiered royalties ranging
from a mid-single to low double-digit percentage based on the Company's
worldwide annual net sales of GTX-102 (as a single agent or in a combination
product) and tiered royalties ranging from mid to high single-digit percentage
based on the Company's worldwide annual net sales of products other than GTX-102
that are covered by certain of GeneTx's patents or are developed with,
manufactured using, or practice GeneTx know-how. The Company is also required to
pay an amount equal to either (i) 30% of the cash value of consideration
received (net of certain specified fees and commissions) upon the sale by the
Company of a priority review voucher awarded by the FDA in connection with a
rare pediatric product application for GTX-102 ("PRV") or (ii) $25.0 million if
the Company chooses to retain the PRV.
The Purchase Agreement contains customary representations and warranties of the
parties and provides for indemnification of the Company by the Unitholders,
subject to customary limitations. The representations, warranties and covenants
contained in the Purchase Agreement were made only for purposes of such
agreement and as of specific dates, were solely for the benefit of the parties
to the Purchase Agreement, and are subject to limitations set forth in the
Purchase Agreement.
The foregoing description of the terms of the Purchase Agreement is qualified in
its entirety by reference to the full text of the Purchase Agreement, a copy of
which the Company intends to file with the Securities and Exchange Commission
(the "SEC") as an exhibit to the Company's Quarterly Report on Form 10-Q.
Item 2.01 Completion of Acquisition or Disposition of Assets.
The information set forth in Item 1.01 of this Current Report on Form 8-K is
incorporated herein by reference in response to this Item 2.01.
Item 7.01 Regulation FD.
On July 18, 2022, the Company posted a presentation ("Presentation") related to
a program update for GTX-102 to its website at www.ultragenyx.com in the "Events
and Presentations" subsection of the "Investors and Media" tab.
The information set forth under Item 7.01 and in the Presentation shall not be
deemed "filed" for purposes of Section 18 of the Securities Exchange Act of
1934, nor shall it be deemed incorporated by reference in any filing under the
Securities Act of 1933, except as shall be expressly set forth by specific
reference in any such filing
Item 8.01 Other Events.
On July 18, 2022, the Company issued a press release announcing the acquisition
of GeneTx and a program update, including interim data results from the
Company's ongoing Phase 1/2 study of GTX-102.
Item 9.01 Financial Statements and Exhibits.
(d)Exhibits
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Exhibit No. Description
99.1 Press Release, dated July 18, 2022.
104 The cover page from the Company's Current Report on Form 8-K dated
July 15, 2022 formatted in Inline XBRL.
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