February 01, 2017: Lannett Company reports Q2 EPS of $0.92 versus the $0.83 estimate. Revenue also beat coming in at $170.9 million versus the $169 million estimate.
The CEO said, “Higher sales across a number of products and the addition of KU’s operations were key drivers to the 35% increase in our fiscal 2017 second quarter net sales… Our outlook for the current fiscal year remains strong. During the quarter, we received several product approvals and continued to make excellent progress integrating KU’s operations and consolidating our manufacturing, sales, R&D and distribution functions. And more recently, we voluntarily paid down $75 million of debt, lowering our annualized cash interest expense by approximately $4 million, and our board of directors approved a plan to invest in our pain management facilities, which will significantly increase our active pharmaceutical ingredients (APIs) production and bolster our efforts to vertically integrate.”
January 3, 2016: Lannett received approval last week from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Lopinavir and Ritonavir Oral Solution USP, 80 mg/20 mg per mL, the therapeutic equivalent to the reference listed drug, KaletraOral Solution of AbbVie Inc. Lannett, the first applicant to file a substantially complete ANDA for Lopinavir and Ritonavir Oral Solution USP, 80 mg/20 mg per mL with a Paragraph IV certification, may be eligible for 180 days of generic drug marketing exclusivity for the product, although the FDA has not made a final determination at this time.
The CEO said, “Lopinavir and Ritonavir Oral Solution, indicated for HIV-1 infections, represents the twelfth product approval we received in calendar 2016 and extends our line of oral generic drugs. This approval comes from our wholly owned subsidiary, Silarx Pharmaceuticals, which we acquired nearly 18 months ago to diversify our manufacturing capabilities and differentiate our product offering. I commend our entire regulatory team for the approval of this first-to-file, Paragraph IV product. We anticipate launching our product shortly.”
I predict a future trend of increased ANDA approvals from the FDA including legislation that will lean in favor of generic drug companies like Lannett in response to the practice by some pharmaceutical companies of buying older drugs, then jacking up the price to astronomical levels.
December 19, 2016: Lannett announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Supplemental New Drug Application (sNDA) for Morphine Sulfate Oral Solution CII, color and flavor added, 20 mg/mL. According to IMS, total U.S. sales for the 12 months ended October 2016 of Morphine Sulfate Oral Solution, at Average Wholesale Price (AWP) were approximately $22 million.
Morphine Sulfate Oral Solution is an opioid agonist indicated for the management of acute and chronic pain in opioid-tolerant patients severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
November 28, 2016: Lannett announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Metaxalone Tablets USP, 800 mg, the therapeutic equivalent to the reference listed drug, Skelaxinof King Pharmaceuticals, Inc. According to IMS, total U.S. sales for the 12 months ended September 2016 of Metaxalone Tablets USP, 800 mg, at Average Wholesale Price (AWP) were approximately $173 million.
Lannett Stock Chart
The Finviz screener settings used to find Lannett are: Forward P/E Under 10, EPS growth past 5 years Over 30%, Sales growth past 5 years Over 30%, Sales growth qtr over qtr Over 30%, Institutional Transactions Positive (>0%)
Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a broad range of medical indications.
Fox Business’ Maria Bartiromo interviewed Lannett Company CEO Arthur Bedrosian back on December 23, 2015.