MannKind Corporation Announces Q3 2024 Financial Results and Business Update

MannKind Corporation, based in Danbury, Connecticut, and Westlake Village, California, has released its financial results for the third quarter of 2024, showcasing significant growth and progress in various areas. Michael Castagna, CEO of MannKind, highlighted the company's impressive revenue growth and clinical advancements. The company saw total revenues of $70 million, a 37% increase compared to the same period in 2023. Year-to-date revenues for 2024 reached $209 million, marking a 49% increase over the previous year. Net income for the year so far stands at $20 million, with non-GAAP net income at $45 million.

Revenue growth was primarily driven by royalties from Tyvaso DPI, which increased by 34% to $27.1 million, and revenue from collaborations and services, which surged by 78% to $23.3 million. Afrezza net revenue also saw a 12% rise to $15 million, while V-Go net revenue experienced a modest 5% increase to $4.7 million. The commercial product gross margin improved to 84%, up from 78% in the previous year, mainly due to the increase in Afrezza net revenue.

The company also reported a significant rise in cost of revenue for collaborations and services, which increased by $4.5 million to $14.8 million, attributed to higher manufacturing volumes for Tyvaso DPI. Research and development expenses grew by $2.9 million to $12.9 million, driven by the costs associated with the Phase 3 clinical study of MNKD-101 and the Phase 1 study of MNKD-201, as well as increased personnel costs following a transaction with Pulmatrix, Inc.

Selling expenses slightly decreased by $0.3 million to $13.1 million, primarily due to reduced personnel costs from a sales force restructuring earlier in the year, offset by increased promotional activities. General and administrative expenses saw a marginal increase of $0.3 million to $10.8 million due to higher personnel costs, partially offset by reduced consulting fees.

Interest income doubled to $3.2 million, a result of increased investments and higher yields on the company's securities portfolio. However, interest expenses related to the sale of future royalties and financing liabilities remained significant, with the former amounting to $4.1 million and the latter staying consistent at $2.5 million. The company also reported a $1 million decrease in interest expense due to the repayment of the MidCap credit facility and Mann Group convertible note in April 2024.

A notable gain on bargain purchase of $5.3 million was recorded, stemming from the Pulmatrix transaction where the fair value of net assets acquired exceeded the consideration paid.

For the nine months ended September 30, 2024, MannKind's total revenues reached $208.7 million, a 49% increase compared to the same period in 2023. This growth was driven by a 48% increase in royalties from Tyvaso DPI, a 108% surge in revenue from collaborations and services, and a 16% rise in Afrezza net revenue. However, V-Go net revenue declined by 6% due to lower product demand, despite improved pricing and gross-to-net adjustments.

The company's commercial product gross margin increased to 79%, up from 73% the previous year, primarily due to higher Afrezza net revenue. Research and development expenses rose significantly by $12.8 million to $34.8 million, largely due to ongoing development activities, clinical studies, and increased personnel costs post-Pulmatrix transaction. Selling expenses decreased by $4.6 million to $36.2 million, reflecting reduced personnel costs. General and administrative expenses saw a slight increase to $34.2 million.

Interest income for the nine months doubled to $9.8 million, while interest expenses relating to the sale of future royalties and financing liabilities remained substantial. The company also reported a $7.1 million loss on extinguishment of debt due to the repayment of the MidCap credit facility and Mann Group convertible note.

MannKind's cash, cash equivalents, and investments as of September 30, 2024, were $268.4 million. The company presented non-GAAP financial measures to provide additional insights into its operating results, indicating a non-GAAP net income of $44.8 million for the nine months ended September 30, 2024, compared to a non-GAAP net loss of $1.3 million for the same period in 2023.

In terms of clinical development, MannKind reported significant progress in its ongoing trials. The Phase 3 trial of MNKD-101 for NTM lung disease is expanding globally, and the Phase 1 trial of MNKD-201 for IPF was successfully completed. The company also announced positive topline results from the Afrezza INHALE-3 post-marketing study and expects to release topline data from the Phase 3 INHALE-1 pediatric study by the end of the year. MannKind plans to meet with the FDA in the first half of 2025 to discuss the next steps for MNKD-201.

MannKind will discuss these results in a conference call today at 4:30 p.m. ET, which will be accessible via a webcast on their website.