Ligand Pharmaceuticals Incorporated filed SEC Form 8-K: Other Events
$LGND
Biotechnology: Pharmaceutical Preparations
Health Care
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
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CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 27, 2024
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Item 8.01 Other Events.
On June 27, 2024, Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) (the “Company”) announced that its partner Verona Pharma plc has received approval from the U.S. Food and Drug Administration (“FDA”) for OhtuvayreTM (ensifentrine), the first inhaled product with a novel mechanism of action available for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients in more than 20 years. The Company has earned a $5.8 million milestone payment upon FDA approval of Ohtuvayre and will earn an additional $13.8 million upon its commercial launch which is expected to occur during the third quarter of 2024. COPD is a multi-billion-dollar market opportunity in the U.S. The Company is entitled to a low single-digit royalty on potential worldwide net sales of Ohtuvayre.
Forward-Looking Statements
This report contains forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. Words such as “plans,” “believes,” “expects,” “anticipates,” “potential,” “will” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding: the timing of the anticipated commercial launch of Ohtuvayre by Verona; the timing and amount of milestone payments Ligand expects; and the potential royalties to be paid on sales of Ohtuvayre by Verona. Actual events or results may differ from Ligand’s or its partner’s expectations due to risks and uncertainties inherent in Ligand’s and its partner’s business, including, without limitation: Verona may not be able to successfully commercialize Ohtuvayre which will depend on a number of factors including coverage and reimbursement levels from governmental authorities and health insurers as well as market acceptance by healthcare providers; the market size for Ohtuvayre may be smaller than estimated; Ligand is dependent on Verona for the commercialization of Ohtuvayre; and other risks described in Ligand’s prior filings with the Securities and Exchange Commission available at www.sec.gov. The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand’s stock price. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| LIGAND PHARMACEUTICALS INCORPORATED | |||||
| Date: June 27, 2024 | By: /s/ Andrew Reardon Name: Andrew Reardon Title: Chief Legal Officer and Secretary | ||||