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LANTHEUS HOLDINGS, INC.

(LNTH)
  Report
Delayed Nasdaq  -  04:00:00 2023-02-03 pm EST
60.80 USD   +0.23%
01/13POINT Biopharma Completes Randomization in PNT2002's Phase 3 SPLASH TrialEnrollment for the randomization phase of SPLASH completed prior to EOY 2022, meeting previous guidance
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01/13POINT Biopharma Completes Randomization in PNT2002's Phase 3 SPLASH Trial
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01/12POINT Biopharma Completes Randomization in PNT2002’s Phase 3 SPLASH Trial
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LANTHEUS HOLDINGS, INC. : Entry into a Material Definitive Agreement, Other Events, Financial Statements and Exhibits (form 8-K)

11/14/2022 | 07:32am EST

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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© Edgar Online, source Glimpses

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