LCI may start to climb after today's FDA approvalLannett stock has struggled lately due to opioid litigation and a weakening of its earnings forecast back in November. However, the company announced several product launches in December and early January, and today Lannett got FDA approval for, of all things, a cocaine-based anesthetic nasal spray. The stock has shown little positive reaction to any of this news, but that might change if analysts start to adjust their earnings forecasts to reflect the new product offerings. Despite its underwhelming reaction to the news today, I think Lannett may start to show momentum this week as investors digest the announcement from today.
Lannett has an attractive forward P/E of 6.84 and a history of beating analyst expectations on its earnings reports. Its last round of guidance was neutral, with increased administrative and sales costs offset by decreased tax burden and interest expense. Lannett should have enough cash on hand to cover its product launches thanks to a convertible notes offering last year. It has about $100 million in cash per its last earnings report, although with apparently $66 million in debt due toward the end of this year.
Fdaapproval
$KDMN Set To Keep Climbing$KDMN is set up well both technically and fundamentally. The FDA just approved CLOVIQUE (TM), A Room-Temperature Stable Trientine Hydrochloride Product. This bodes well for the company as it moves forward. According to the press release:
Product Offers Room Temperature Stability, Improving Convenience for Patients
NEW YORK, NY / ACCESSWIRE / October 21, 2019 / Kadmon Holdings, Inc. (KDMN) today announced that the U.S. Food and Drug Administration (FDA) has approved CLOVIQUE™ (Trientine Hydrochloride Capsules, USP), a room-temperature stable, branded generic product. Trientine hydrochloride is used for the treatment of Wilson's disease in patients who are intolerant of penicillamine.
CLOVIQUE is the first FDA-approved trientine product in a portable blister pack that offers room temperature stability for up to 30 days, potentially providing patients more convenience. In a recently published survey, approximately 30% of Wilson's disease patients cited product storage as a medication-associated inconvenience of disease management.1
"CLOVIQUE is an innovative treatment option that can be stored at room temperature, which is an added convenience for Wilson's disease patients," said Harlan W. Waksal, M.D., President and CEO of Kadmon. "We are pleased to offer CLOVIQUE to patients in need as part of our goal to develop novel therapies for chronic, rare diseases."
Kadmon has immediately commenced commercialization activities for CLOVIQUE through Kadmon Pharmaceuticals, its wholly-owned commercial operation.
In September 2019, the FDA approved Kadmon's generic Trientine Hydrochloride Capsules USP, 250 mg, available in 100-count bottles. The FDA had determined Kadmon's Trientine Hydrochloride Capsules to be bioequivalent and therapeutically equivalent to the reference listed drug, Syprine® Capsules, 250 mg.
About Wilson's Disease
Wilson's disease is a rare genetic disorder causing excess copper accumulation in the body that results in neurological and metabolic adverse events.
About Kadmon
Kadmon is a biopharmaceutical company developing innovative products for significant unmet medical needs. Our product pipeline is focused on inflammatory and fibrotic diseases as well as immuno-oncology.
As always, use protective stops and trade with caution.
Good luck to all!
