MannKind Corp. Announces Q2 2024 Financial Results and Clinical Update

MannKind Corporation, headquartered in both Danbury, Connecticut, and Westlake Village, California, released its financial results for the quarter ending June 30, 2024. The CEO, Michael Castagna, celebrated the company’s ninth consecutive quarter of revenue growth, highlighting a projected annual revenue surpassing $275 million. Castagna emphasized the importance of their diversified strategy, focusing on their pipeline, in-line growth, and debt reduction, which he believes will deliver sustainable value to shareholders.

For the second quarter of 2024, MannKind reported total revenues of $72.4 million, marking a 49% increase compared to the same period in 2023. This surge was largely driven by significant gains in collaboration and services revenue, which rose by 132% to $26 million. Royalties from Tyvaso DPI® also saw a 34% increase, amounting to $25.6 million, due to heightened sales by United Therapeutics. Furthermore, Afrezza® net revenue went up by 20%, reaching $16.3 million, attributed to price adjustments and higher demand. Conversely, V-Go® net revenue slightly declined by 7% to $4.5 million due to reduced product demand.

The company's commercial product gross margin for Q2 2024 was 73%, up from 72% in the same period of the previous year, primarily due to increased Afrezza revenue. The cost of revenue for collaborations and services rose to $14.8 million from $9 million, reflecting higher manufacturing volumes for Tyvaso DPI, which led to better production efficiencies.

R&D expenses climbed to $11.8 million, up from $6.5 million, mainly due to increased costs associated with developing clofazimine inhaled suspension (MNKD-101), an Afrezza pediatric study (INHALE-1), and the initiation of a Phase 1 clinical study for nintedanib (MNKD-201). Selling expenses decreased to $11.5 million from $14 million, primarily due to a sales force restructuring.

General and administrative costs increased slightly to $12.6 million, influenced by higher estimated returns for V-Go and personnel costs. Interest income more than doubled to $3.2 million due to better yields on securities and increased investments. However, interest expenses, including costs related to the sale-leaseback of MannKind's Danbury facility and other debts, remained significant.

For the first half of 2024, total revenues reached $138.6 million, a 55% increase from the same period in 2023. Royalties from Tyvaso DPI rose by 57%, while collaborations and services revenue surged by 125%. Afrezza net revenue increased by 18%, although V-Go net revenue saw an 11% decline. The commercial product gross margin for the first half of 2024 improved to 76%, up from 70%.

Increased manufacturing activities contributed to a higher cost of revenue for collaborations and services, which totaled $29.6 million. R&D expenses for the first half of 2024 were $21.8 million, up from $12.1 million, due to ongoing clinical studies and increased headcount. Selling expenses dropped to $23.1 million from $27.3 million following a sales force restructuring.

General and administrative expenses edged up to $23.3 million, while interest income rose to $6.6 million. Interest expenses slightly decreased, partly due to the repayment of certain debts in April 2024. MannKind reported a net income of $9 million for the first half of 2024, contrasting with a net loss of $15 million in 2023.

MannKind also provided updates on its clinical developments. The Afrezza INHALE-3 study showed promising results, improving the ability to achieve target A1c levels and generating significant interest among participants. Data from the pediatric INHALE-1 study is expected later in 2024, with an FDA submission planned for 2025. The MNKD-101 Phase 3 trial for clofazimine inhalation suspension has commenced, aiming to evaluate 180 patients across up to 120 global sites. Additionally, the MNKD-201 Phase 1 trial for a dry-powder formulation of nintedanib is underway, with results anticipated by the end of 2024.

Overall, MannKind’s financial performance and strategic advancements indicate a robust trajectory towards sustained growth and development in the field of inhaled therapeutic products.