1Q 2024 Total revenues of $66M; +63% vs. 1Q 2023 1Q 2024 Net income of $11M; Non-GAAP net income of $15M $304M of cash and cash equivalents and investments at March 31, 2024 In early April, repaid Midcap senior-secured debt and Mann Group convertible debt totaling approximately $37M FDA Fast Track designation and IND clearance received for MNKD-101 DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today reported financial results for the quarter ended March 31, 2024. "We achieved our eighth consecutive quarter of revenue growth putting us on a run rate of over $250 million in revenue for 2024," said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. "In the last week, we received Fast Track designation and clearance of the IND for MNKD-101 which may allow us to bring this innovative product to patients more quickly." Revenue Highlights     Three Months Ended March 31,       2024     2023     $ Change     % Change       (Dollars in thousands)   Royalties – collaborations   $ 22,651     $ 11,678     $ 10,973       94 % Revenue – collaborations and services     24,848       11,386     $ 13,462       118 % Net revenue – Afrezza     14,438       12,423     $ 2,015       16 % Net revenue – V-Go     4,326       5,139     $ (813 )     (16 %) Total revenues   $ 66,263     $ 40,626     $ 25,637       63 %                                   Royalties related to Tyvaso DPI for the first quarter of 2024 increased $11.0 million, or 94%, due to increased patient demand. Collaborations and services revenue increased $13.5 million, or 118%, compared to the same period in 2023 primarily attributable to an increase in manufacturing Tyvaso DPI for United Therapeutics ("UT"). Afrezza® net revenue for the first quarter of 2024 increased $2.0 million, or 16%, compared to the same period in 2023 as a result of higher price (including a decrease in gross-to-net adjustments). V-Go® net revenue for the first quarter of 2024 decreased $0.8 million, or 16%, compared to the same period in 2023 as a result of lower product demand. Commercial product gross margin in the first quarter of 2024 was 80% compared to 69% for the same period in 2023. The increase in gross margin was primarily attributable to an increase in Afrezza net revenue. Cost of revenue – collaborations and services for the first quarter of 2024 was $14.8 million compared to $10.7 million for the same period in 2023. The $4.1 million increase was primarily attributable to increased manufacturing volume and related production activities. Higher manufacturing volumes resulted in efficiencies which contributed to a lower effective cost per unit. Research and development ("R&D") expenses for the first quarter of 2024 were $10.0 million compared to $5.6 million for the same period in 2023. The $4.4 million increase was primarily attributed to increased development activities for clofazimine inhaled suspension (MNKD-101), costs for an Afrezza post-marketing clinical study (INHALE-3) which commenced in the second quarter of 2023 and personnel expenses due to increased headcount. Selling expenses were $11.6 million in the first quarter of 2024 compared to $13.3 million for the same period in 2023. The $1.7 million decrease was primarily due to reduced personnel and travel expenses related to sales force restructuring activities completed during the quarter. General and administrative expenses for the first quarter of 2024 were $10.7 million compared to $10.5 million for the same period in 2023. The $0.2 million increase was primarily attributable to a loss of $1.2 million related to estimated returns associated with sales of V-Go that pre-date our acquisition of the product, partially offset by reduced personnel costs. Interest income, net, was $3.4 million for the first quarter of 2024 compared to $1.3 million for the same period in 2023. The $2.1 million increase was primarily due to higher yields on our securities portfolio and an increase in the underlying investments from the proceeds of the sale of 1% of our Tyvaso DPI royalties in December 2023. Interest expense on notes was $2.6 million and interest expense on financing liability (related to the sale-leaseback of our Danbury manufacturing facility) was $2.4 million for the first quarter of 2024 and remained consistent with the same period in 2023. Interest expense on liability for sale of future royalties was $4.2 million for the first quarter of 2024 due to imputed interest and amortization of debt issuance costs on the liability recorded in connection with the sale of a portion of our future royalties in December 2023. Cash, cash equivalents and investments as of March 31, 2024 were $304.5 million. Non-GAAP Measures To supplement our condensed consolidated financial statements presented under U.S. generally accepted accounting principles ("GAAP"), we are presenting non-GAAP net income (loss) and non-GAAP net income (loss) per share - diluted, which are non-GAAP financial measures. We are providing these non-GAAP financial measures to disclose additional information to facilitate the comparison of past and present operations, and they are among the indicators management uses as a basis for evaluating our financial performance. We believe that these non-GAAP financial measures, when considered together with our GAAP financial results, provide management and investors with an additional understanding of our business operating results, including underlying trends. These non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with our condensed consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that we may exclude for purposes of our non-GAAP financial measures; and we may in the future cease to exclude items that we have historically excluded for purposes of our non-GAAP financial measures. Likewise, we may determine to modify the nature of adjustments to arrive at our non-GAAP financial measures. Because of the non-standardized definitions of non-GAAP financial measures, the non-GAAP financial measures as used by us in this report have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to similarly titled measures used by other companies. The following table reconciles our financial measure for net income (loss) and net income (loss) per share ("EPS") for diluted weighted average shares as reported in our condensed consolidated statements of operations to a non-GAAP presentation as adjusted for select non-cash items: 1% royalty on net revenues for Tyvaso DPI ("sold portion of royalty revenue") and interest expense on the related liability, stock-based compensation expense and (gain) loss on foreign currency transaction for the periods presented:   Three Months     Ended March 31,     2024     2023     Net Income     Diluted EPS     Net Loss     Diluted EPS     (In thousands except per share data)   GAAP reported $ 10,630     $ 0.04     $ (9,795 )   $ (0.04 ) Select non-cash adjustments:                       Sold portion of royalty revenue (1)   (2,265 )     (0.01 )     —       —   Interest expense on liability for sale of future royalties   4,248       0.01       —       —   Stock compensation   3,885       0.01