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 (Nasdaq: MNKD) and United Therapeutics have submitted a new drug application (NDA) to the FDA for Tyvaso DPI, a dry powder formulation of treprostinil. This marks a significant milestone as it follows MannKind's earlier product, Afrezza. The NDA submission could expedite the review process, with a potential FDA decision by December 2021. If approved, Tyvaso DPI aims to provide an innovative inhalation therapy for patients with pulmonary arterial hypertension (PAH) and associated conditions, impacting around 75,000 patients in the U.S.
MannKind Corporation (Nasdaq: MNKD) has announced the issuance of an additional $30 million in 2.50% Convertible Senior Notes due 2026, following the full exercise of the initial purchasers' option. This brings the total net proceeds from the offering to approximately $222.9 million. The notes will accrue interest at 2.50% annually, with a conversion rate of 191.8281 shares per $1,000 principal, translating to an initial conversion price of about $5.21 per share, a 30% premium over the stock's last reported sale of $4.01. The funds will be used for working capital and a Phase 3 clinical trial of Afrezza.
MannKind Corporation (Nasdaq: MNKD) announced its participation in the 2022 Medicare Part D Senior Savings Model to enhance insulin affordability for Medicare beneficiaries, capping monthly co-pays at $35 for its inhaled insulin, Afrezza®. With one-third of Medicare beneficiaries having diabetes, this initiative aims to alleviate cost barriers to treatment. MannKind's CEO, Michael Castagna, emphasized the importance of this model in improving healthcare access for seniors. The company recently launched AfrezzaAssist to further assist patients with affordability programs, including co-pay and cash purchase options.
MannKind Corporation (Nasdaq: MNKD) announced that its CEO, Michael Castagna, PharmD, will take part in a Fireside Chat at the Oppenheimer 31st Annual Healthcare Conference on March 17, 2021, at 1:50 PM (ET). Investors can access the webcast via the Events & Presentations section of MannKind's website, with a replay available for 14 days post-event. MannKind specializes in inhaled therapies for endocrine and orphan lung diseases, including the FDA-approved Afrezza inhalation powder, the only inhaled ultra rapid-acting mealtime insulin available in the U.S.
MannKind Corporation (Nasdaq: MNKD) announced that CEO Michael Castagna will present at the H.C. Wainwright Global Life Sciences Conference. The presentation will be available on demand starting March 9, 2021, at 7:00 am (ET). Interested viewers can access the webcast link from the Events & Presentations section of MannKind's website. The replay will be available for 14 days after the live event. MannKind focuses on inhaled therapeutic products, including the FDA-approved Afrezza®, an ultra-rapid-acting mealtime insulin available by prescription in the U.S. and Brazil.
MannKind Corporation (Nasdaq: MNKD) announced the pricing of $200 million of 2.50% Convertible Senior Notes due 2026. The offering to qualified institutional buyers is set to close on March 4, 2021. The notes will accrue interest at 2.50% per annum, payable semiannually. The initial conversion price is approximately $5.21 per share, a premium of 30% over the last sale price of $4.01. Net proceeds of approximately $193.8 million will fund working capital, including a Phase 3 clinical trial of Afrezza and other corporate purposes.
MannKind Corporation (NASDAQ: MNKD) announced a private placement offering of $150 million in Convertible Senior Notes due 2026. The offering may increase by an additional $22.5 million. Proceeds will support working capital, a Phase 3 clinical trial of Afrezza in pediatric patients, and development of other products. The notes are unsecured, and upon conversion, MannKind may pay in cash, stock, or both. The company does not currently plan to use proceeds for debt repayment or acquisitions. The securities will not be registered under the Securities Act.
MannKind Corporation (MNKD) reported its fourth quarter and full-year 2020 results, highlighting Afrezza net revenue of $10.1 million, a 30% increase year-over-year. Total revenues for 2020 reached $65.1 million, with Afrezza contributing $32.3 million. The company experienced a net loss of $26.4 million in Q4 and $57.2 million for the year. Gross profit from Afrezza surged 230% to $17.2 million. The acquisition of QrumPharma for $12.8 million and entering into a co-promotion agreement for Thyquidity are key strategic moves. Cash reserves stood at $67.2 million at year-end.
Vertice Pharma launched THYQUIDITY, a liquid levothyroxine solution, on February 24, 2021. This product is designed for patients with hypothyroidism, providing precise, individualized dosing. THYQUIDITY will serve as a replacement therapy for various types of hypothyroidism and assist in managing thyroid cancer. The product contains 100 mcg per 5 mL and is supplied in two 100 mL bottles. MannKind Corporation (NASDAQ: MNKD) will co-promote THYQUIDITY to healthcare providers. This marks Vertice's first branded pharmaceutical product aimed at improving patient health.
MannKind Corporation (Nasdaq: MNKD) will have its CEO, Michael Castagna, PharmD, participate in a Fireside Chat at the 2021 SVB Leerink Global Healthcare Conference on February 25, 2021, at 1:00 pm (ET). Interested individuals can access the webcast through the Company's website, with a replay available for 14 days post-event. MannKind is known for developing inhaled therapeutic products, including Afrezza® (insulin human) Inhalation Powder, the only FDA-approved inhaled ultra rapid-acting mealtime insulin in the U.S.