MannKind Corporation reports developments across its biopharmaceutical business in cardiometabolic and orphan lung diseases. Company updates center on commercial products such as Afrezza, an inhaled insulin for diabetes, and Furoscix, a furosemide injection for fluid overload in heart failure and chronic kidney disease, as well as financial results, product demand, launch infrastructure and capital-structure actions.
MannKind news also covers dry powder inhalation programs and drug-device combinations, including work using its Technosphere platform. Recurring topics include Afrezza clinical and real-world data, Furoscix device and regulatory updates, Nintedanib DPI for idiopathic pulmonary fibrosis, ralinepag DPI collaboration activity with United Therapeutics, and other pipeline decisions affecting inhaled therapies.
MannKind Corporation (MNKD) reported Q2 2021 revenues of $23.3 million, a 54% increase year-over-year, driven by Afrezza net revenue of $10.0 million. The company reported a net loss of $35.5 million, or $0.14 per share, compared to a net loss of $10.3 million in Q2 2020. Gross profit from Afrezza surged 68% to $5.6 million, enhancing gross margin to 56% (or 76% on a non-GAAP basis). Cash equivalents amounted to $201.4 million as of June 30, 2021, bolstered by $230 million in convertible notes issued earlier this year.
NRx Pharmaceuticals has partnered with MannKind Corporation to develop a dry powder formulation of ZYESAMI™ (aviptadil) for respiratory conditions. Utilizing MannKind's Technosphere® platform, the collaboration aims to create an inhalable delivery system that enhances patient convenience. ZYESAMI™ has shown promising results in clinical trials for COVID-19 patients. NRx has received Fast Track Designation from the FDA and is conducting phase 3 trials for both intravenous and inhaled formulations, funded by the NIH and BARDA.
MannKind Corporation (Nasdaq: MNKD) has partnered with NRx Pharmaceuticals (Nasdaq: NRXP) to explore a dry powder formulation of ZYESAMI (aviptadil), aimed at treating respiratory failure due to COVID-19. Currently, ZYESAMI's intravenous formulation is in clinical trials with FDA Fast Track Designation. MannKind's CEO emphasized the potential of their Technosphere technology for delivering treatments effectively. The research is set to occur at MannKind's Danbury facility, which has significant production capabilities.
MannKind Corporation (Nasdaq:MNKD) will announce its Q2 2021 financial results on August 11, 2021, at 5 PM ET. The conference call will feature insights from CEO Michael Castagna and CFO Steven B. Binder. Investors can access the call and the subsequent replay on MannKind's website. MannKind focuses on inhaled therapeutic products, notably the FDA-approved Afrezza, the only inhaled ultra-rapid-acting insulin available in the U.S. and Brazil. The company was founded in 1991 and is based in Westlake Village, California.
MannKind Corporation (Nasdaq: MNKD) announced that CEO Michael Castagna will participate in a Fireside Chat at the BTIG Virtual Biotechnology Conference on August 10, 2021, at 12:30 PM (ET). This event is exclusive to BTIG clients. MannKind focuses on developing and marketing inhaled therapies for patients with endocrine and orphan lung diseases. Its leading product is Afrezza®, the only inhaled ultra-rapid-acting mealtime insulin available in the U.S. for prescription.
MannKind Corporation (Nasdaq: MNKD) is partnering with U.S. professional racing driver Conor Daly, who has Type 1 diabetes, to engage local youth during the Music City Grand Prix week. Scheduled for August 4, 2021, Daly will share his diabetes journey and racing tips while racing go-karts with participants. Known for his resilience, Daly was diagnosed at 14 yet has competed successfully in over 70 Indy car races. This initiative aims to inspire youth and raise awareness of living with diabetes, emphasizing that it should not limit one's aspirations.
MannKind Corporation (Nasdaq: MNKD) announced a positive policy change by the Centers for Medicare and Medicaid Services (CMS) effective July 18, 2021. This change to the Local Coverage Determination (LCD) L33822 allows Medicare patients with diabetes to use both Afrezza® and Continuous Glucose Monitors (CGMs) simultaneously. Previously, patients had to choose between the two, which resulted in Medicare denials. MannKind's CEO emphasized the importance of patient convenience, while experts anticipate broader access for Afrezza users, enhancing diabetes management options.
MannKind Corporation (Nasdaq: MNKD) presented two posters at the American Diabetes Association's virtual 81st Scientific Sessions from June 25-29, focusing on its inhaled insulin, Afrezza®. Poster 923-P details a Phase 2 clinical study demonstrating the pharmacokinetics and safety of Afrezza in pediatric patients with type 1 diabetes, showing no severe hypoglycemic events. Poster 722-P presents findings from a Levin study indicating that Afrezza helps reduce hyperglycemia in patients with uncontrolled type 2 diabetes, improving daytime time-in-range by 83.5%. MannKind is set to initiate a Phase 3 study in fall 2021.
MannKind Corporation (Nasdaq: MNKD) and United Therapeutics Corporation (Nasdaq: UTHR) announced the FDA's acceptance for priority review of the New Drug Application (NDA) for Tyvaso DPI™. This inhaled treatment addresses pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The review is set to conclude by October 2021, with no identified review issues thus far. This marks the second FDA review for a product developed using MannKind's Technosphere® technology, following the approved Afrezza®.
MannKind Corporation (Nasdaq: MNKD) announces the FDA's acceptance of the NDA for Tyvaso DPI™, intended for pulmonary arterial hypertension treatment. The priority review is expected to complete by October 2021, with no identified review issues so far. This advancement follows the company's collaboration with United Therapeutics to develop Tyvaso DPI, using MannKind’s Technosphere® technology. Additionally, MannKind is expanding its manufacturing facility in Connecticut, planning to hire over 100 employees to support the pre-launch inventory of Tyvaso DPI.