MNKD — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-05

• The other major program in our pipeline that will potentially address an orphan lung disease is MNKD-201, a dry-powder formulation of nintedanib for the treatment of idiopathic pulmonary fibrosis (or IPF). An oral dosage form of nintedanib has been available for more than a decade. However, a fairly…

• Gross revenue from sales of Afrezza decreased by $2.8 million, or 6%, for the six months ended June 30, 2026 compared to the same period in the prior year. The decrease was driven primarily by lower demand. The gross-to-net adjustment was 32% of gross revenue, or $15.2 million, for the six months en…

• Furoscix — Gross revenue from sales of Furoscix was $31.1 million for the three months ended June 30, 2026. The gross-to-net adjustment was 29% of gross revenue, or $8.9 million, resulting in net revenue of $22.2 million for the three months ended June 30, 2026. Gross revenue from sales of Furoscix …

• V-Go — Gross revenue from sales of V-Go decreased by $2.7 million, or 40%, for the three months ended June 30, 2026 compared to the same period in the prior year and was primarily a result of lower demand. The gross-to-net adjustment was 32% of gross revenue,

• or $1.3 million, for the three months ended June 30, 2026 compared to 39% of gross revenue, or $2.6 million, for the same period in the prior year. As a result, net revenue from sales of V-Go decreased by $1.4 million, or 33%, for the three months ended June 30, 2026 compared to the same period in t…

Text removed vs the prior filing · source: 10-Q · 2026-05-06

• We anticipate two potential milestones for our cardiometabolic business in 2026 based on regulatory submissions that we made in 2025. The FDA is currently reviewing a supplemental biologics license application (or sBLA) pursuant to which we are seeking approval for Afrezza in children and adolescent…

• will formulate ralinepag (MNKD-1501) as a dry powder using our proprietary technologies. United Therapeutics will conduct preclinical and clinical development activities of MNKD-1501. Per the agreement, we received an upfront payment and are eligible to receive milestone payments upon achievement of…

• The other major program in our pipeline that will potentially address an orphan lung disease is MNKD-201, a dry-powder formulation of nintedanib for the treatment of idiopathic pulmonary fibrosis (or IPF). An oral dosage form of nintedanib has been available for more than a decade. However, a fairly…

• Furoscix — Gross revenue from sales of Furoscix was $20.9 million for the three months ended March 31, 2026. The gross-to-net adjustment was 26% of gross revenue, or $5.4 million, resulting in net revenue of $15.5 million for the three months ended March 31, 2026. There was no Furoscix revenue in th…

• V-Go — Gross revenue from sales of V-Go decreased by $1.5 million, or 23%, for the three months ended March 31, 2026 compared to the same period in the prior year and was primarily a result of lower demand. The gross-to-net adjustment was 36% of gross revenue, or $1.8 million, for the three months e…

Text added vs the prior filing · source: 10-Q · 2026-08-05

• We are subject to stringent, ongoing government regulation.*

• As part of the approval of Afrezza, the FDA required us to conduct certain additional clinical studies of Afrezza, including a long-term safety study that was originally intended to compare the incidence of pulmonary malignancy observed with Afrezza to that observed in a standard of care control gro…

• care related legislation that could impact the drug approval process and make changes to the Medicare Drug Price Negotiation Program. We cannot predict which additional measures may be adopted or the impact of current and additional measures on the marketing, pricing and demand for our products, whi…

• regulatory investigations and actions, and lawsuits. If we are unable to use generative AI, it could make our business less efficient and result in competitive disadvantages.

Text removed vs the prior filing · source: 10-Q · 2026-05-06

• As part of the approval of Afrezza, the FDA required us to conduct certain additional clinical studies of Afrezza, including a long-term safety study that was originally intended to compare the incidence of pulmonary malignancy observed with Afrezza to that observed in a standard of care control gro…

• approvals, or failure to comply with existing or future regulatory requirements could have a material adverse effect on our business and results of operations.

• for Afrezza outside of the United States. In such event and subject to the terms of our agreements with our ex-U.S. partners, we may choose to forgo the ex-U.S. market. Likewise, our royalty revenue from Tyvaso DPI could suffer for the same reason. In June 2024, the U.S. Supreme Court’s Loper Bright…

• payments and other transfer of value to physicians and other healthcare providers and entities; marketing expenditures or drug pricing.