MannKind Corp. reported a substantial rise in revenue and a shrinking net loss in the third quarter of 2021 on Nov. 9, despite news since the quarter ended that the U.S. Food and Drug Administration will not yet approve a hypertension treatment the company is developing with United Therapeutics.
MannKind, a Westlake Village-based biotechnology company that develops drugs and treatments for those suffering from diabetes and pulmonary arterial hypertension, delivered year-over-year revenue growth of 45% for the quarter ended Sept. 30. Revenue was at $22.2 million in the third quarter of 2021, an increase of $6.9 million from the third quarter of 2020.
The growth in revenue could be directly attributed to MannKind’s Afrezza inhaler product and treatment, which saw sales increase 34% as a result of higher prescription demand and price, including lower gross-to-net deductions, the company said. Afrezza sales were $12.5 million in the third quarter of 2021, compared to $7.5 million a year earlier.
In the third quarter of 2021, MannKind’s net loss was $4.4 million, or 2 cents per share. That was an improvement over the previous year’s third quarter, when the company lost $11.3 million, or 5 cents per share. Afrezza’s gross profit for the third quarter of 2021 was $5.9 million, compared to $3.7 million in the same period of 2020.
The smaller net loss was a direct result of the big growth seen by Afrezza, the company said in a news release. Afrezza is an inhaled insulin treatment for patients with type 1 and type 2 diabetes.
“The MannKind team continues to stay focused and execute our corporate objectives of preparing for the commercial launch of Tyvaso DPI, moving our pipeline forward and growing Afrezza,” MannKind CEO Michael Castagna said in the release.
MannKind’s third quarter was spoiled a bit after it ended, by the FDA’s news on Oct. 18 that it declined to approve a new drug application for Tyvasio DPI, a treatment being developed by MannKind and United for pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.
MannKind’s shares dropped 18% on the news to $4.16. The shares have recovered some of that loss and closed at $4.81 on Nov. 10.
Plans to resubmit the drug are underway and Castagna said during the company’s earnings call that he expects FDA approval by the summer of 2022.
Castagna told the Business Times last month that United Therapeutics has agreed to a 10-year agreement to supply Tyvaso. This is a longer-term commitment than the companies’ original five-year deal, he said.
MannKind ended the third quarter with $181.1 million in cash and cash equivalents.