MNKD 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-06

• We are 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 hypert…

• Our cardiometabolic business is currently comprised of three commercial products: Afrezza (insulin human) Inhalation Powder; Furoscix (furosemide injection); and the V-Go wearable insulin delivery device:

• Afrezza is an ultra rapid-acting inhaled insulin indicated to improve glycemic control in adults with diabetes. Afrezza was developed by us and consists of a dry powder formulation of human insulin delivered from a small portable inhaler. Administered at the beginning of a meal, Afrezza dissolves ra…

• Furoscix is a novel formulation of furosemide that delivers an 80 mg dose via an on-body infusor over a five-hour period. Furoscix is approved by the U.S. Food and Drug Administration (or FDA) for the treatment of edema in pediatric patients who weigh at least 43 kg and adult patients with chronic h…

• V-Go is a mechanical basal-bolus insulin delivery system that is worn like a patch and can eliminate the need for taking multiple daily injections. V-Go administers a continuous preset basal rate of insulin over 24 hours and provides discreet on-demand bolus dosing at mealtimes. V-Go received 510(k)…

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• We are a biopharmaceutical company focused on the development and commercialization of patient-centric therapies that address serious unmet medical needs for those living with cardiometabolic and orphan lung diseases. We currently commercialize two products: Afrezza (insulin human) Inhalation Powder…

• Our pipeline of potential treatments for orphan lung diseases includes inhaled clofazimine (MNKD-101) for the treatment of severe chronic and recurrent pulmonary infections, including nontuberculous mycobacterial ("NTM") lung disease. The FDA has designated inhaled clofazimine as both an orphan drug…

• In October 2025, we acquired scPharmaceuticals Inc. ("scPharma") whose approved product, Furoscix, consists of a novel formulation of furosemide delivered via scPharma’s device supplier-developed on-body infusor, which delivers an 80 mg/10 mL dose over five hours. Furoscix was approved by the FDA fo…

• As of September 30, 2025, we had cash, cash equivalents and investments of $286.3 million, an accumulated deficit of $3.2 billion and a total stockholders’ deficit of $44.6 million. We had net income of $8.0 million and $21.8 million for the three and nine months ended September 30, 2025, respective…

• Afrezza and V-Go, from royalties and manufacturing revenue from UT, from proceeds of the sale-leaseback of our manufacturing facility in Danbury, CT and from the sale of a portion of future royalties that we receive from UT.

相对上期新增的文字 · 来源:10-Q · 2026-05-06

• If United Therapeutics reduces its commercial emphasis on Tyvaso DPI, our revenues could decline materially.

• Our products, product candidates and technology may not be able to compete effectively or may be rendered obsolete.

• We may not realize the anticipated benefits of the scPharma acquisition or any future acquisition or strategic transaction; we may be unable to successfully integrate new products, technologies or businesses we acquire.

• Healthcare legislation may impact the net sales of commercial products sold by us or any partner.

• If United Therapeutics reduces its commercial emphasis on Tyvaso DPI, our revenues could decline materially.*

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• Our products and product candidates may be rendered obsolete by rapid technological change.

• In order to increase adoption and sales of our products, we need to continue to develop our commercial organization, including maintaining and growing a highly experienced and skilled workforce with qualified sales representatives.*

• With the closing of our acquisition of scPharma, we now have two sales forces that promote our products to different target groups of physicians. In order to successfully commercialize our approved products, we must continue to build our sales, marketing, distribution, managerial and other commercia…

• Similarly, the drug formulation and device components of FUROSCIX are manufactured for us by third parties. In addition to the risks identified above, any future curtailment in the availability of materials could result in production or other delays with consequent

• adverse effects on us. In addition, because regulatory authorities must generally approve raw material sources for pharmaceutical products, changes in raw material suppliers may result in production delays or higher raw material costs.

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• (3) These trading plans include the potential exercise and sale by Michael Castagna and David Thomson of short-dated options and performance options exercisable for up to 692,665 and 280,355 shares of common stock, respectively. The remainder of the plan for David Thomson, as well as the plan for St…