Insulin Recombinant Human(MannKind)

肺癌是全球最高发的实体瘤，每年新发患者240万人，每年引发死亡180万人，30年蝉联全球头号肿瘤杀手。 作为全人类共同的挑战，患者和药企都在努力克服病难，而药企的持续创新与进阶正逐渐成为抗癌的“利器”。 可进阶大厂，至少应拥有一款代表性大药，就像率先生产出人胰岛素、研制出超级重磅药物赫赛汀的生物技术巨头“基因泰克”一样。 当患者在传统治疗中屡屡碰壁，当免疫疗法遭遇耐药困境，一款靶向PD-L1的抗体偶联药物（ADC）正从中国药企走向世界舞台，引起业内轰动。 是的，国产创新药又有新突破，这家药企不仅要做first-in-class，更要做中国的“基因泰克”。 针对肺癌，复宏汉霖（02696.HK）已成功推出9款上市产品；而且，还有6款产品在海外获批上市，覆盖全球60余个国家和地区。 作为第一家凭借产品销售实现盈利的18A创新药企，复宏汉霖已经连续三年实现盈利，如今更是进入创新药爆发期。 二级市场也开始关注医药企业更核心的价值——创新。 年初至今，复宏汉霖股价一飞冲天，涨幅超过200%，年内最高点较最低点涨幅一度逼近500%。 究其根本，它成功打造汉曲优与汉斯状两款10亿+级别重磅单品并手握全球首个进入临床II期的PD-L1靶向ADC药物HLX43，全球潜力不小。 值得一提的是，正是国产创新药企的推陈出新，才有了今日中国在创新药领域的不断突破。 以复宏汉霖为代表的本土企业正通过斯鲁利单抗等“中国方案”展现了创新实力，推动中国原研药物走向国际。 2025年前三季度，中国创新药License-out（对外授权）总金额突破900亿美元，BD交易总额超千亿美元，单笔交易屡创新高，反映全球对中国创新药价值的认可。 现在创新药行业的一个共识是，中国必将涌现国际化大厂。‌ 从跟随仿制到自主创新，创新药出海见证着中国生物医药从“制造”到“创造”的转变。

Q3 2025 revenues of $82.1M , +17% v. Q3 2024 YTD 2025 revenues of $237.0M , +14% v. YTD 2024 Completed acquisition of scPharmaceuticals on October 7 , accelerating MannKind’s revenue growth with FUROSCIX® Program updates: sBLA for Afrezza® in pediatric population accepted for FDA review; PDUFA date of May 29, 2026 FUROSCIX ReadyFlow™ Autoinjector sNDA submitted to the FDA MNKD-101 NTM global Phase 3 trial (ICoN-1) achieved interim enrollment target ahead of schedule MNKD-201 IPF Phase 2 trial (INFLO) initiated and expect to enroll first patient in Q1 2026 sBLA for Afrezza® in pediatric population accepted for FDA review; PDUFA date of May 29, 2026 FUROSCIX ReadyFlow™ Autoinjector sNDA submitted to the FDA MNKD-101 NTM global Phase 3 trial (ICoN-1) achieved interim enrollment target ahead of schedule MNKD-201 IPF Phase 2 trial (INFLO) initiated and expect to enroll first patient in Q1 2026 DANBURY, Conn. and WESTLAKE VILLAGE, Calif. , Nov. 05, 2025 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today reported financial results for the third quarter of 2025 and provided a business update. “The acquisition of scPharmaceuticals marks a significant expansion of our commercial capabilities and is expected to accelerate growth of our product revenues and build upon our commitment to delivering innovative, patient-centric therapies,” said Michael Castagna , PharmD, Chief Executive Officer of MannKind Corporation . “With the FDA’s acceptance for review of the Afrezza pediatric sBLA, the submission of the FUROSCIX ReadyFlow Autoinjector sNDA, and continued progress in the pipeline programs, we are executing across a diversified portfolio with significant growth opportunities ahead.” Business Update and Upcoming Milestones scPharmaceuticals Acquisition Completed the previously announced acquisition of scPharmaceuticals on October 7, 2025 Expected to diversify and accelerate MannKind’s double-digit revenue growth, driven by FUROSCIX (furosemide injection), an innovative therapy for edema due to chronic heart failure and chronic kidney disease FUROSCIX ReadyFlow Autoinjector supplemental New Drug Application (sNDA) filing submitted as planned in Q3 2025; review acceptance decision expected by YE 2025 Expected to diversify and accelerate MannKind’s double-digit revenue growth, driven by FUROSCIX (furosemide injection), an innovative therapy for edema due to chronic heart failure and chronic kidney disease Afrezza FDA accepted for review the sBLA for Afrezza® (insulin human) Inhalation Powder in the pediatric population (aged 4 – 17 years) and assigned a PDUFA date of May 29, 2026 Topline results from the full pediatric study including the safety extension to be discussed at the International Society for Pediatric and Adolescent Diabetes meeting, November 5-8, 2025 Application to update labeling regarding initial Afrezza conversion dose under FDA review; decision expected Q1 2026 Afrezza performance Q3 2025 compared to Q3 2024: $18.5 million v. $15.0 million , a 23% increase Inhaled Clofazimine MNKD-101 (nebulized) Phase 3 global clinical trial for the treatment of NTM (ICoN-1) achieved interim enrollment target of 100 patients ahead of schedule; interim analysis (study sample size re-estimation) expected mid-year 2026 MNKD-102 (DPI) advancing program following the completion of initial pre-clinical studies in NTM Nintedanib DPI (MNKD-201) Initiated IPF Phase 2 clinical trial (INFLO) and plan to enroll first patient in Q1 2026 Pre-clinical Formulating a second dry powder investigational molecule under the expanded collaboration with United Therapeutics using MannKind’s proprietary Technosphere® platform Bumetanide DPI pre-clinical study planned Corporate and Financial Appointed Dr. Ajay Ahuja as Chief Medical Officer Cash, cash equivalents and investments as of September 30, 2025 totaled $286.3 million ; In October 2025 , MannKind utilized approximately $133.2 million of available cash, cash equivalents and investments and borrowed an additional $250.0 million in delayed draw term loans to fund the acquisition of scPharmaceuticals and the related debt extinguishment Third Quarter 2025 Financial ResultsRevenues Total revenues increased $12.1 million , or 17% for the third quarter of 2025 compared to the same period in the prior year. Revenue increases were driven by royalties earned on increased net sales of Tyvaso DPI®, higher revenue from collaborations and services due to increased product sold to United Therapeutics Corporation (“UT”) and MannKind’s co-promotion agreement with Amphastar, as well as higher commercial product revenue for Afrezza, mainly due to higher price and demand and a lower rate of sales deductions. There was a decrease in net revenue for V-Go® due to lower demand, partially offset by higher price and lower rebates on certain commercial contracts. Operating Expenses and Other Financial Highlights Research and development expenses increased by $1.1 million , or 9%, for the third quarter of 2025 compared to the same period in the prior year. The increase was primarily attributable to continued patient enrollment in the ICoN-1 study for MNKD-101, and the clinical production scale up for MNKD-201. These increases were partially offset by the completion of the INHALE-3 clinical study of Afrezza and the Phase 1 study of MNKD-201 in 2024, as well as lower costs for the INHALE-1 pediatric clinical study of Afrezza, which was closed out in the second quarter of 2025. Selling, general and administrative expenses increased by $5.2 million , or 22%, for the third quarter of 2025 compared to the same period in the prior year. The increase was primarily driven by higher headcount and personnel-related costs, including the deployment of a medical science liaison team and higher Afrezza promotional costs. Additionally, general and administrative expenses included incremental costs associated with the acquisition of scPharmaceuticals which was completed in October 2025 . Gain on foreign currency transaction was $0.1 million for the third quarter 2025 compared to a loss of $2.5 million for the same period in the prior year. These non-cash changes were due to fluctuations in U.S. dollar to Euro exchange rates. Under the Company’s Insulin Supply Agreement with Amphastar, payment obligations for future purchases are denominated in Euros. The Company records the foreign currency transaction impact of the U.S. dollar to Euro exchange rate associated with the future purchase commitments. Impairment of available-for-sale investment of $6.4 million for the three months ended September 30, 2025 was a result of the write-off of the Thirona investment. For the third quarter of 2025, the Company reported net income of $8.0 million , or $0.03 earnings per share – basic, compared to net income of $11.6 million , or $0.04 earnings per share – basic, for the same period in 2024, a decrease in net income of $3.6 million . For the third quarter of 2025, the Company reported non-GAAP net income of $22.4 million , or $0.07 earnings per share – basic, compared to non-GAAP net income of $15.4 million , or $0.06 earnings per share – basic, for the same period in 2024, an increase in non-GAAP net income of $7.0 million , or 45%. For a reconciliation of GAAP reported net income and net income per share for basic weighted average shares to these non-GAAP measures, please see Non-GAAP Measures below. Nine Months Ended September 30, 2025 Revenues Total revenues increased $28.3 million , or 14%, for the nine months ended September 30, 2025 compared to the same period in the prior year. Revenue increases were driven by royalties earned on increased net sales of Tyvaso DPI®, higher revenue from collaborations and services due to increased product sold to UT and MannKind’s co-promotion agreement with Amphastar, as well as higher commercial product revenue for Afrezza, mainly due to higher price and demand, partially offset by a decrease in net revenue for V-Go® due to lower demand. The decrease in demand for V-Go was partially offset by higher price and lower rebates on certain commercial contracts. Operating Expenses and Other Financial Highlights Research and development expenses increased by $4.0 million , or 12%, for the nine months ended September 30, 2025 compared to the same period in the prior year. The increase was primarily attributable to continued patient enrollment in ICoN-1 study, clinical production scale up for MNKD-201, and personnel costs primarily due to additional headcount as a result of the Pulmatrix transaction in the third quarter of 2024, which bolstered research capabilities and capacity. These increases were partially offset by the completion of the INHALE-3 study, the Phase 1 and toxicology studies for MNKD-201 in 2024 as well as lower costs for the INHALE-1 study, which was closed out in the second quarter of 2025. Selling, general and administrative expenses increased by $15.4 million , or 22%, for the nine months ended September 30, 2025 compared to the same period in the prior year. The increase was largely attributable to higher headcount and personnel-related expenses as well as deploying a medical science liaison team and Afrezza promotional costs. Additionally, general and administrative expenses included incremental costs associated with the acquisition of scPharmaceuticals, which was completed in October 2025 . These increases were partially offset by a $1.4 million charge recorded in the prior year period for estimated returns associated with sales of V-Go that pre-dated the Company’s acquisition of the product. Loss on foreign currency transactions was $7.8 million for the nine months ended September 30, 2025 , compared to a loss of $0.5 million for the same period in the prior year. These non-cash changes were due to fluctuations in U.S. dollar to Euro exchange rates related to the future purchase commitments. Impairment of available-for-sale investment of $6.4 million for the nine months ended September 30, 2025 was a result of the write-off of the Thirona investment. Impairment of available-for-sale investment for the nine months ended September 30, 2024 was $1.6 million as a result of modification of the Thirona investment. For the nine months ended September 30, 2025 , the Company reported net income of $21.8 million , or $0.07 earnings per share – basic, compared to net income of $20.2 million , or $0.07 earnings per share – basic, for the same period in 2024, an increase in net income of $1.6 million . For the nine months ended September 30, 2025 , the Company reported non-GAAP net income of $58.0 million , or $0.19 earnings per share – basic, compared to non-GAAP net income of $44.8 million , or $0.16 earnings per share – basic, for the same period in 2024, an increase in non-GAAP net income of $13.2 million , or 30%. For a reconciliation of GAAP reported net income and net income per share for basic weighted average shares to these non-GAAP measures, please see Non-GAAP Measures below. Conference Call MannKind will host a conference call and presentation webcast to discuss these results today at 9:00 a.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) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. Focused on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, and fluid overload in heart failure and chronic kidney disease. With deep expertise in drug-device combinations, MannKind aims to deliver therapies designed to fit seamlessly into daily life. Learn more at mannkindcorp.com. 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 potential benefits from the scPharma acquisition, including diversifying and accelerating revenue growth; MannKind’s ongoing clinical trials and preclinical studies, including the Phase 3 clinical trial of MNKD-101 and the timing for patient enrollment for and an interim analysis thereof and the Phase 2 study of MNKD-201 and the expected initiation and patient enrollment timelines thereof, and the expected timing for trial results; the development of a new dry powder inhalation therapy and investigational molecule under the expanded collaboration with United Therapeutics and the planned preclinical studies thereof; the expected timing for regulatory events related to Afrezza and the FUROSCIX ReadyFlow™ Autoinjector; and other statements about future events. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “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 and uncertainties associated with competition; commercial execution; regulatory changes impacting the pharmaceutical, medical device and healthcare industries; developing product candidates; unforeseen delays that may impact the timing of clinical trials and reporting data; the regulatory review process; manufacturing; intellectual property protection; personnel; and macroeconomic and geopolitical factors. These and other risks are detailed in MannKind’s filings with the Securities and Exchange Commission (“SEC”), including under the “Risk Factors” heading of its most recently filed Quarterly Report 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, FUROSCIX, MANNKIND , SCPHARMACEUTICALS and V-GO are registered trademarks and FUROSCIX READYFLOW is a trademark of MannKind Corporation or its subsidiaries. Non-GAAP MeasuresTo supplement MannKind's condensed consolidated financial statements presented under GAAP, we are presenting non-GAAP financial measures for net income and net income per share – basic. We are providing these non-GAAP financial measures, which are among the indicators management uses as a basis for evaluating our financial performance, to disclose additional information to facilitate the comparison of past and present operations. 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 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 press release 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 and net income per share ("EPS") for basic weighted average shares as reported in our condensed consolidated statements of operations to a non-GAAP presentation: 1) Represents the non-cash portion of the 1% royalty on net sales of Tyvaso DPI earned during the three and nine months ended September 30, 2025 and 2024, which is remitted to the royalty purchaser and recognized as royalties from collaborations in our condensed consolidated statements of operations. Our royalties from collaborations during the three and nine months ended September 30, 2025 totaled $33.3 million and $94.6 million , respectively, of which $3.3 million and $9.5 million , respectively were remitted to the royalty purchaser.2) Represents transaction fees incurred during the three and nine months ended September 30, 2025 associated with the acquisition of scPharma. Source: MannKind