On May 9, 2023 MannKind Corporation (Nasdaq: MNKD) reported financial results for the quarter ended March 31, 2023 (Press release, Mannkind, MAY 9, 2023, View Source [SID1234631279]).
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"Demand for Tyvaso DPI has been very strong, which resulted in $23 million in revenues in the first quarter of 2023," said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. "I’m excited about our inhaled platform and orphan lung pipeline as we get ready to launch our Phase 2/3 inhaled clofazimine trial for patients in the second half of 2023."
Revenue Highlights
Three Months
Ended March 31,
2023 2022 $ Change % Change
(Dollars in thousands)
Net revenue – Afrezza $ 12,423 $ 9,826 $ 2,597 26 %
Net revenue – V-Go 5,139 — $ 5,139 *
Revenue – collaborations and services 11,386 2,166 $ 9,220 426 %
Royalties – collaborations 11,678 — $ 11,678 *
Total revenues $ 40,626 $ 11,992 $ 28,634 239 %
___________________
* Not meaningful
Afrezza net revenue for the first quarter of 2023 increased compared to the same period in 2022 as a result of higher product demand, higher price (including a more favorable gross-to-net adjustment) and a more favorable cartridge mix. V-Go was acquired in the second quarter of 2022. The increase in collaborations and services revenue reflected that the commercial manufacturing of Tyvaso DPI had not yet commenced in the prior period. Royalties related to Tyvaso DPI, launched in the second quarter of 2022 by United Therapeutics ("UT"), continued to grow based on strong patient demand.
Commercial product gross margin in the first quarter of 2023 was 69% compared to 77% for the same period in 2022 primarily related to the addition of V-Go in the second quarter of 2022 which had a lower gross margin than Afrezza.
Cost of revenue – collaborations and services for the first quarter of 2023 was $10.7 million compared to $8.7 million for the same period in 2022, an increase of $2.0 million, due to an increase in manufacturing activities for Tyvaso DPI.
Research and development expenses for the first quarter of 2023 were $5.6 million compared to $3.5 million for the same period in 2022. The $2.1 million increase was primarily attributed to costs incurred to develop our product pipeline, including MNKD-101 (inhaled clofazimine) and the Afrezza pediatrics clinical study (INHALE-1).
Selling expenses for the first quarter of 2023 were $13.3 million compared to $12.7 million for the same period in 2022. The $0.6 million increase was primarily due to V-Go promotional efforts and increased headcount after the acquisition in the second quarter of 2022 as well as an increase in Afrezza promotional activities, partially offset by the termination of an Afrezza pilot promotional effort targeting primary care physicians which ended in the third quarter of 2022.
General and administrative expenses for the first quarter of 2023 were $10.5 million compared to $7.9 million for the same period in 2022. The $2.6 million increase was primarily attributable to higher stock-based compensation, increased headcount, and higher professional fees.
Interest expense on financing liability was $2.4 million for the first quarter of 2023 and remained consistent with the same period in 2022.
Interest expense on notes was $2.8 million in the first quarter of 2023 and remained consistent with the same period in 2022 due to fixed interest rates and no changes in debt balances.
Cash, cash equivalents and investments as of March 31, 2023 were $166.6 million.
Conference Call
MannKind will host a conference call and presentation webcast to discuss these results today at 5:00 p.m. Eastern Time. Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at mannkindcorp.com under Events & Presentations. A replay will be available on MannKind’s website for 14 days.