Item 1.01 Entry Into a Material Definitive Agreement
On November 11, 2022, Lantheus Two, LLC ("Lantheus Two"), an indirect wholly
owned subsidiary of Lantheus Holdings, Inc. (the "Company"), entered into
a license and collaboration agreement (the "PNT-2002 License Agreement") with an
affiliate of POINT Biopharma Global Inc. ("POINT"), to co-develop and
commercialize PNT-2002, a prostate-specific membrane antigen-targeted
radiopharmaceutical therapy for the treatment of metastatic castrate-resistant
prostate cancer. Lantheus Medical Imaging, Inc. ("LMI"), a wholly owned
subsidiary of the Company, will guarantee Lantheus Two's obligations under the
PNT-2002 License Agreement. Pursuant to the terms of the PNT-2002 License
Agreement, POINT has granted to Lantheus Two exclusive rights to develop and
commercialize PNT-2002 worldwide, except certain countries in Asia (the
"Territory"). The parties' collaboration is governed through an executive
steering committee and joint functional steering committees. The effectiveness
of the transactions contemplated under the PNT-2002 License Agreement are
subject to specified conditions, including the expiration or early termination
of any waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of
1976, as amended (the "HSR Act").
POINT is generally responsible for funding and development activities required
for U.S. Food and Drug Administration ("FDA") approval of PNT-2002, including
generating all clinical and nonclinical data, analysis and other information,
and Lantheus Two is responsible for preparing for and seeking regulatory
approval for PNT-2002, as well as performing and funding all future development
and commercialization of PNT-2002 following such approval. POINT will be
responsible for all manufacturing of PNT-2002, subject to certain exceptions
described in the PNT-2002 License Agreement.
Under the terms of the PNT-2002 License Agreement, Lantheus Two will pay POINT
an upfront cash payment of $250 million within five business days after the
PNT-2002 License Agreement becomes effective, with the potential for up to an
additional $281 million in milestone payments upon the achievement of specified
U.S. and ex-U.S. regulatory milestones related to PNT-2002. POINT is also
eligible to receive up to $1.28 billion in sales milestone payments upon the
achievement of specified annual sales thresholds of PNT-2002. In addition, after
Lantheus Two achieves $500 million in cumulative Gross Profit, POINT is eligible
to receive royalty payments of twenty percent of net sales of PNT-2002 in the
Territory. Prior to achieving that financial recoupment threshold, POINT is
eligible to receive royalty payments of twenty percent on that portion of annual
net sales of PNT-2002 in the Territory that generate annual gross profit in
excess of specified levels.
The PNT-2002 License Agreement will remain in effect, unless terminated earlier,
until the expiration of all royalty terms for PNT-2002 in the Territory. The
PNT-2002 License Agreement may be terminated for cause by either party based on
uncured material breach of the other party or bankruptcy of the other party. The
PNT-2002 License Agreement may be terminated prior to becoming effective upon
the failure of certain closing conditions or upon notice from either party if
the PNT-2002 License Agreement has not been consummated on or prior to June 30,
2023, which date Lantheus Two may extend to August 30, 2023 upon payment of an
extension fee. Lantheus Two may terminate the PNT-2002 License Agreement without
cause on specified notice periods, subject to the passage of time and specified
milestones or triggers. Upon early termination by either party, all licenses
granted by the parties will automatically terminate.
The description of the PNT-2002 License Agreement in this Current Report on Form
8-K does not purport to be complete and is qualified in its entirety by
reference to the PNT-2002 License Agreement, a copy of which is attached hereto
as Exhibit 10.1 and incorporated by reference herein.
Item 8.01 Other Events
Also on November 11, 2022, Lantheus Three, LLC ("Lantheus Three" and, together
with Lantheus Two, "Lantheus LLC"), an indirect wholly owned subsidiary of the
Company, entered into a license and collaboration agreement (the "PNT-2003
License Agreement" and, together with the PNT-2002 License Agreement, the
"License Agreements") with POINT to co-develop and commercialize PNT-2003, a
somatostatin receptor targeted radioligand ("SSTR") therapy with non-carrier
added lutetium-177, which is in development to treat patients with SSTR-positive
neuroendocrine tumors. LMI will guarantee Lantheus Three's obligations under the
PNT-2003 License Agreement. Pursuant to the terms of the PNT-2003 License
Agreement, POINT has granted to Lantheus Three exclusive rights to develop and
commercialize PNT-2003 in the Territory. The parties' collaboration is governed
through an executive steering committee and joint functional steering
committees. The effectiveness of the transactions contemplated under the
PNT-2003 License Agreement are subject to specified conditions, including the
expiration or early termination of any waiting period under the HSR Act.
POINT is responsible for curating all data, analysis and other information
necessary for regulatory approval, and supporting Lantheus in the preparation of
regulatory filings for PNT-2003, and Lantheus Three is responsible for preparing
for and seeking regulatory approval of all such applications, as well as
performing and funding all future development and commercialization of PNT-2003
following such approval. POINT will be responsible for all manufacturing of
PNT-2003, subject to certain exceptions described in the PNT-2003 License
Agreement.
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Under the terms of the PNT-2003 License Agreement, Lantheus Three will pay POINT
an upfront cash payment of $10 million within five business days after the
PNT-2003 License Agreement becomes effective, with the potential for up to an
additional $34.5 million in milestone payments upon the achievement of specified
U.S. and ex-U.S. regulatory milestones related to PNT-2003. POINT is also
eligible to receive up to $275 million in sales milestone payments upon the
achievement of specified annual sales thresholds of PNT-2003. In addition, POINT
is eligible to receive royalty payments of fifteen percent of net sales of
PNT-2003 in the Territory.
The PNT-2003 License Agreement will remain in effect, unless terminated earlier,
until the expiration of all royalty terms for PNT-2003 in the Territory. The
PNT-2003 License Agreement may be terminated for cause by either party based on
uncured material breach of the other party or bankruptcy of the other party. The
PNT-2003 License Agreement may be terminated prior to becoming effective upon
the failure of certain closing conditions or upon notice from either party if
the PNT-2003 License Agreement has not been consummated on or prior to June 30,
2023, which date Lantheus Three may extend to August 30, 2023 at its option. At
any time after filing the first application for obtaining market authorization
for PNT-2003 with the FDA, Lantheus Three may terminate the PNT-2003 License
Agreement without cause on 30 days' prior written notice. Upon early termination
by either party, all licenses granted by the parties will automatically
terminate.
The description of the PNT-2003 License Agreement in this Current Report on Form
8-K does not purport to be complete and is qualified in its entirety by
reference to the PNT-2003 License Agreement, a copy of which is attached hereto
as Exhibit 10.2 and incorporated by reference herein.
Forward-Looking Statements
This Current Report on Form 8-K and information included herein, contain
forward-looking statements relating to, among other things, Lantheus LLC's
partnership with POINT and the success thereof; POINT's and Lantheus LLC's
abilities to successfully develop and commercialize PNT-2002 and PNT-2003; and
POINT's eligibility to receive development, regulatory and commercial milestone
payments and royalties under the License Agreements. Any such statements that
are not statements of historical fact may be deemed to be forward-looking
statements. Words such as "potential," "may," "will," "expects" and similar
expressions are intended to identify these forward-looking statements. These
forward-looking statements are based on the current expectations of the Company
and inherently involve significant 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, without limitation, risks that the FDA or other regulatory authorities
may make adverse decisions regarding PNT-2002 or PNT-2003; risks regarding
closing conditions under the agreement with POINT, including review under
the HSR Act; risks related to POINT's and Lantheus LLC's decisions regarding
development, manufacture and commercialization of PNT-2002 and PNT-2003; risks
that PNT-2002 and PNT-2003 clinical trials may not be predictive of real-world
results or of results in subsequent clinical trials; the availability of
resources to develop these product candidates; market competition; as well as
other risks detailed from time to time in the Company's reports filed with the
Securities and Exchange Commission. The Company does not undertake any
obligation to update any forward-looking statements and expressly disclaims any
obligation or undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
Exhibit
Number Exhibit Description
10.1* License and Collaboration Agreement between Point Biopharma, Inc.
and Lantheus Two, LLC, dated as of November 11, 2022
10.2* License and Collaboration Agreement between Point Biopharma , Inc.
and Lantheus Three, LLC, dated as of November 11, 2022
104 Cover Page Interactive Data File (embedded within the Inline XBRL
document)
* Certain confidential portions (indicated by brackets and asterisks) have been
omitted from this exhibit.
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