Nintedanib esylate

2024 revenues of $286M , +43% v. 2023; 4Q 2024 revenues of $77M , +31% v. 4Q 2023 2024 net income of $28M ; Non-GAAP net income of $68M 4Q 2024 net income of $7M ; Non-GAAP net income of $23M Reduced debt principal by $236M ; remaining convertible debt of $36M Year-end 2024 cash, cash equivalents and investments of $203M Advanced pipeline: Reported primary endpoint of INHALE-1 for Afrezza in pediatrics Progressed MNKD-101 to Global Phase 3 Completed Phase 1 of MNKD-201 Reported primary endpoint of INHALE-1 for Afrezza in pediatrics Progressed MNKD-101 to Global Phase 3 Completed Phase 1 of MNKD-201 DANBURY, Conn. and WESTLAKE VILLAGE, Calif. , Feb. 26, 2025 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today reported financial results for the quarter and year ended December 31, 2024 , and provided a business update. “Throughout 2024, we accomplished the milestones we outlined at the beginning of the year, including delivering robust revenues as we exited the year with an annual run rate of $300 million ,” said Michael Castagna , PharmD, Chief Executive Officer of MannKind Corporation . “We are thrilled to have welcomed Dominic Marasco as President, Endocrine Business Unit, positioning Afrezza for further growth, including a planned submission this summer to seek approval in the pediatric population. In our orphan lung clinical programs, nintedanib DPI is progressing to the next phase of development and our Phase 3 trial of clofazimine inhalation suspension in NTM lung disease is expected to meet the interim enrollment target by the end of 2025.” 4Q 2024 Business Update and Upcoming Milestones Afrezza® INHALE-1 Pediatric Phase 3 clinical trial Six-month safety and efficacy results announced Requested meeting with the U.S. Food and Drug Administration ("FDA") in 1H 2025 to discuss data submission for potential approval of Afrezza in the pediatric population Expect twelve-month data set with safety extension in 1H 2025 Anticipate supplemental new drug application filing in 1H 2025 pending FDA feedback Clofazimine Inhalation Suspension Phase 3 (ICON-1) global clinical trial (MNKD-101) Approximately 70% of anticipated sites have been activated in four countries ( U.S. , Japan , Australia , South Korea ) Patients randomized in two countries ( U.S. and Australia ) Expect to meet the interim enrollment target by YE 2025 Nintedanib DPI Phase 1 clinical trial (MNKD-201) Successfully completed Phase 1 trial, demonstrating nintedanib DPI was well tolerated with no serious adverse events or study drug discontinuation reported Expect to meet with the FDA in 1H 2025 to advance MNKD-201 into next phase of development Commercial – Endocrine Business Unit Announced the appointment of Dominic Marasco as President, Endocrine Business Unit Afrezza INHALE-3 Phase 4 clinical trial 17-week data published in Diabetes Care; 30-week data manuscripts expected to be published in 1H 2025 Inhaled insulin recognized as comparable to injectable insulin in the American Diabetes Association ® Standards of Care in Diabetes – 2025 Label application to update initial Afrezza conversion dose submitted to FDA Afrezza approved in India for adults; expect to ship in 4Q 2025 once Cipla obtains registration certificate and import license; earned $1.1M regulatory milestone Corporate and Financial: Strong Balance Sheet Cash, cash equivalents and investments as of December 31, 2024 totaled $203 million Eliminated principal of $236 million across three debt instruments during 2024 resulting in: Remaining outstanding debt balance of $36 million in 2.5% senior convertible notes due 2026 Utilized a combination of cash and stock to avoid potential dilution of 12 million shares of common stock Interest expense savings of $9 million through the respective maturity dates Remaining outstanding debt balance of $36 million in 2.5% senior convertible notes due 2026 Utilized a combination of cash and stock to avoid potential dilution of 12 million shares of common stock Interest expense savings of $9 million through the respective maturity dates Fourth Quarter and Full Year 2024 Financial Results Revenues Total revenues for the fourth quarter and full year 2024 rose due to increases in revenue from royalties, collaborations and services, and commercial sales. The rise in royalties was primarily due to higher patient demand for Tyvaso DPI. Collaborations and services revenue grew due to increased manufacturing of Tyvaso DPI for United Therapeutics Corporation ("UT"). Net revenues for Afrezza and V-Go increased primarily as a result of improved gross-to-net percentages and higher demand and, to a lesser extent, pricing for Afrezza, partially offset by a decrease in V-Go product demand. Operating Expenses and Other Financial Highlights Cost of revenue – collaborations and services was $14.8 million for the fourth quarter of 2024, compared to $12.0 million for the same period in 2023, an increase of 24%. For the full year 2024, cost of revenue – collaborations and services was $59.2 million , compared to $41.9 million , an increase of 41%. These increases are primarily the result of increased manufacturing volume of Tyvaso DPI. Research and development ("R&D") expenses were $11.1 million for the fourth quarter of 2024 compared to $9.2 million for the same period in 2023, an increase of 21%. For the full year 2024, R&D expenses were $45.9 million compared to $31.3 million , an increase of 47%. The increases were primarily attributable to development activities including the ICON-1 clinical study, a Phase 1 clinical study of MNKD-201, and personnel costs primarily due to increased headcount resulting from the Pulmatrix Transaction. Selling, general and administrative ("SG&A") expenses were $24.0 million for the fourth quarter of 2024 compared to $20.5 million for the same period in 2023, an increase of 17%. For the full year 2024, SG&A expenses remained consistent compared to the same period in 2023. This was primarily attributable to a loss of $1.4 million for estimated returns associated with sales of V-Go that pre-date MannKind's acquisition of the product and increases in personnel costs, professional fees and promotional activities, offset by a decrease in selling expenses related to sales force restructuring activities completed during the first quarter of 2024. For the fourth quarter of 2024, MannKind reported net income of $7.4 million , or $0.03 earnings per share – basic, compared to net income of $1.4 million , or $0.01 earnings per share – basic, for the same period in 2023. For the full year 2024, MannKind reported net income of $27.6 million , or $0.10 earnings per share – basic, compared to net loss of $11.9 million , or $0.04 loss per share – basic for the same period in 2023. For the fourth quarter of 2024, MannKind reported non-GAAP net income of $23.0 million , or $0.08 earnings per share – basic, compared to non-GAAP net income of $7.1 million , or $0.02 earnings per share – basic, for the same period in 2023. For the full year 2024, MannKind reported non-GAAP net income of $67.7 million , or $0.25 earnings per share – basic, compared to non-GAAP net income of $5.9 million , or $0.03 earnings per share – basic for the same period in 2023. For a reconciliation of GAAP reported net income (loss) and net income (loss) per share for basic weighted average shares to these non-GAAP measures, please see the end of this press release. Conference Call MannKind will host a conference call and presentation webcast to discuss these results today at 4:30 p.m. Eastern Time . The webcast will be accessible via a link on MannKind’s website. A replay will also be available in the same location within 24 hours after the call and accessible for approximately 90 days. About MannKind MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies – dry-powder formulations and inhalation devices – offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication. With a passionate team of Mannitarians collaborating nationwide, we are on a mission to give people control of their health and the freedom to live life. Please visit mannkindcorp.com to learn more, and follow us on LinkedIn, Facebook, X or Instagram. Forward-Looking Statements Statements in this press release that are not statements of historical fact are forward-looking statements that involve risks and uncertainties. These statements include, without limitation, statements regarding MannKind's expectations about the development of Afrezza for the pediatric population, MNKD-101 and MNKD-201, including the expected timing for data readouts, regulatory filings, meetings with the FDA and patient enrollment timelines; expectations regarding the commercialization of Afrezza in India , including the estimated timing for the shipment of product; and MannKind being positioned for further growth. Words such as “believes,” “anticipates,” “plans,” “expects,” “intend,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind’s current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with developing product candidates; risks and uncertainties related to unforeseen delays that may impact the timing of clinical trials and reporting data; risks associated with safety and other complications of our products and product candidates; risks associated with the regulatory review process; risks associated with competition; and other risks detailed in MannKind’s filings with the Securities and Exchange Commission (“SEC”), including under the “Risk Factors” heading of its Annual Report on Form 10-K for the year ended December 31, 2024 , being filed with the SEC later today, and subsequent periodic reports on Form 10- Q. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release. Tyvaso DPI is a trademark of United Therapeutics Corporation. AFREZZA, MANNKIND , and V-GO are registered trademarks of MannKind Corporation . _________________(1) Diluted weighted average shares ("DWAS") differs from basic weighted average shares due to the weighted average number of shares that would be outstanding upon exercise or vesting of outstanding share-based payments to employees and conversion of convertible notes. For the year ended December 31, 2024 , DWAS included 9,429 shares issuable upon exercise or vesting of outstanding share-based payments. 6,967 shares issuable upon conversion of our senior convertible notes were excluded as their effect would be antidilutive. Non-GAAP Measures To supplement our consolidated financial statements presented under GAAP, we are presenting non-GAAP net income (loss) and non-GAAP net income (loss) per share - basic, 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 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 its 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 measures for net income (loss) and net income (loss) per share ("EPS") for basic weighted average shares as reported in our consolidated statement of operations to a non-GAAP presentation: _________________(1) Represents the non-cash portion of the 1% royalty on net sales of Tyvaso DPI which is remitted to the royalty purchaser and recognized as royalties from collaborations in our consolidated statements of operations. Source: MannKind

上海 2025年2月24日 /美通社/ -- 勃林格殷格翰今日宣布，其在研肺纤维化疗法口服磷酸二酯酶4B（PDE4B）抑制剂nerandomilast的上市申请已获得中国国家药品监督管理局（NMPA）药品审评中心（CDE）的受理，用于治疗成人特发性肺纤维化（Idiopathic Pulmonary Fibrosis, IPF）。此前，该疗法已被CDE纳入优先审评审批程序，以加速其在中国获批上市的步伐。本次上市申请递交是基于nerandomilast关键性III期临床试验FIBRONEER™-IPF的积极结果，这是十年来首个达到主要终点的IPF III期临床试验。IPF治疗领域有望迎来下一代突破性疗法。 IPF是一种严重的致死性肺部疾病，特征性的表现为肺纤维化程度持续增加、肺功能持续下降、呼吸症状加重，严重影响患者生活质量。IPF的自然病程多变且无法预测，预后不佳，患者在确诊后的中位生存期约为3年 [1] ，比大多数癌症的5年生存率都低，因此又被称为"不是癌症的癌症"。目前，IPF直接的致病途径尚不明确，治疗手段一直十分有限。 Nerandomilast是勃林格殷格翰在研的新型PDE4B抑制剂，其通过抑制PDE4B酶发挥作用，该酶在肺部高度表达，并与纤维化和炎症过程密切相关。通过抑制这些通路，nerandomilast展现了抗纤维化和抗炎的双重效果，有望为IPF患者带来临床获益。2022年，美国食品药品监督管理局（FDA）曾授予nerandomilast突破性疗法认定，凸显了其在IPF治疗中的潜力 [2] 。 Nerandomilast关键性III期临床试验FIBRONEER™-IPF结果显示：与安慰剂相比，接受在研化合物nerandomilast治疗的第52周，患者的用力肺活量（FVC，mL）较基线的绝对变化达到了主要终点 [3],[4] 。研究结果将在今年稍晚时候公布。 勃林格殷格翰大中华区研发和医学负责人张维博士表示："作为肺纤维化领域的领导者，勃林格殷格翰一直以患者需求为中心进行研发创新，特发性肺纤维化一直是临床上极具挑战性的疾病，存在巨大的未被满足的治疗需求。Nerandomilast是我们继维加特 ® 之后研发的又一重磅抗纤维化创新药物，它的到来标志着IPF研发领域的突破性进步。我们将与相关部门紧密合作，期待继续以‘中国速度'推动这款全球创新药在中国获批上市，为中国肺纤维化患者带来全新治疗选择。" 关于特发性肺纤维化（ IPF） 特发性肺纤维化（IPF）是一类最常见的进展性纤维化间质性肺疾病（ILD），其临床症状包括：活动诱发的呼吸急促、持续干咳、胸部不适、疲劳和乏力。尽管被视为"罕见"病，但IPF影响了全球约三百万人 [5],[6] 。该疾病主要影响50岁以上的人群，且男性患者多于女性 [6] 。 关于 nerandomilast Nerandomilast是一款在研的口服磷酸二酯酶4B（PDE4B）抑制剂，正被开发作为特发性肺纤维化（IPF）和进展性肺纤维化（PPF）的潜在治疗药物 [3] 。Nerandomilast于2022年2月获得美国食品药品监督管理局（FDA）授予的特发性肺纤维化（IPF）突破性疗法认定 [3] 。 [1] Strongman H, Kausar I, Maher TM. Incidence, Prevalence, and Survival of Patients with Idiopathic Pulmonary Fibrosis in the UK. Adv Ther. 2018 May;35(5):724-736. [2] Boehringer Ingelheim (2022) FDA Grants BI 1015550 Breakthrough Therapy Designation for Idiopathic Pulmonary Fibrosis. Accessed August 2024. Available at: https://www.boehringer-ingelheim.com/us/human-health/lung-diseases/pulmonary-fibrosis/fda-grants-bi-1015550-breakthrough-therapy . [3] Richeldi L, et al. (2023) Design of a phase III, double-blind, randomised, placebo-controlled trial of BI 1015550 in patients with idiopathic pulmonary fibrosis (FIBRONEER-IPF). In: BMJ Open Respir Res. 2023; 10(1): e001563. [4] Boehringer Ingelheim (2024) A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs). Accessed August 2024. Available at: https://clinicaltrials.gov/study/NCT05321082?tab=results . [5] European Lung Foundation (2023) IPF - Idiopathic Pulmonary Fibrosis. Accessed August 2024. Available at: https://europeanlung.org/en/information-hub/factsheets/ipf-idiopathic-pulmonary-fibrosis/ [6] Koudstaal T, Wijsenbeek MS. Idiopathic pulmonary fibrosis. Presse Med 2023; 52(3):104166.