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) is set to release its 2020 fourth quarter and full year financial results on February 25, 2021, at 9:00 AM ET. The call, featuring CEO Michael Castagna and CFO Steven Binder, will discuss financials and corporate updates. Investors can participate via the company's website or by telephone, with a replay available for 14 days post-call. MannKind focuses on inhaled therapeutic products, commercializing Afrezza, the only FDA-approved inhaled insulin in the U.S., which is also available in Brazil through partner Biomm SA.
MannKind Corporation (Nasdaq: MNKD) announced that its CEO, Michael Castagna, will participate in a Fireside Chat at the H.C. Wainwright Bioconnect 2021 Conference. This event will be available on demand starting January 11, 2021, at 6:00 am (ET). Interested viewers can access the webcast link from the Events & Presentations section on MannKind's website. The replay will remain accessible for 14 days post-event. MannKind specializes in inhaled therapies for endocrine and orphan lung diseases, including Afrezza, the only inhaled ultra rapid-acting mealtime insulin in the U.S.
MannKind Corporation (Nasdaq: MNKD) and Vertice Pharma announced a co-promotion agreement for Thyquidity™ (levothyroxine sodium) oral solution, aimed at treating hypothyroidism. MannKind's sales force will market Thyquidity to US healthcare providers specializing in endocrinology. Vertice will compensate MannKind with quarterly payments and royalties on sales. Michael Castagna, CEO of MannKind, emphasized the arrangement's potential to enhance customer relationships and extend market reach. Thyquidity is indicated for various forms of hypothyroidism, which affects approximately 4.6% of the US population.
MannKind Corporation (Nasdaq: MNKD) has appointed James S. Shannon, M.D., as the new Chairman of the Board effective December 9, 2020. He succeeds Kent Kresa, who remains as a Board member and Chair of the Compensation Committee. Dr. Shannon brings over 20 years of pharmaceutical leadership experience, previously serving as Chief Medical Officer at GlaxoSmithKline and leading Pharma Development at Novartis. This leadership change aims to strengthen MannKind's focus on its pipeline and innovative therapies for endocrine and orphan lung diseases.
MannKind Corporation (Nasdaq: MNKD) has acquired QrumPharma, Inc., a firm focused on inhalation therapies for severe pulmonary infections, including Nontuberculous Mycobacterial (NTM) lung disease. The acquisition includes $3.5 million in cash and 3,067,179 shares of MNKD. The lead product, QRM-003, is set to enter Phase 1 trials by late 2021 and has received FDA orphan drug and QIDP designations. This deal aims to enhance MannKind's pipeline in orphan lung disease treatments and leverage advanced inhalation technologies.
MannKind Corporation (Nasdaq: MNKD) has amended its credit agreement with MidCap Financial Trust, securing $10 million immediately and an additional $25 million contingent upon FDA approval of Treprostinil Technosphere (TreT). The interest-only period extends to September 1, 2022. Key objectives include growing Afrezza as a standard of care for mealtime insulin and advancing TreT toward NDA submission. The amendment also adjusts financial covenants linked to Afrezza's revenue and mandates TreT marketing if Tranche 3 is funded.
MannKind Corporation (NASDAQ: MNKD) announced the appointment of Sabrina Kay, Ed.D., to its Board of Directors, effective December 1, 2020. Dr. Kay will also join the Audit Committee, bringing extensive experience in marketing, finance, and executive leadership. Currently the CEO of Fremont Private Investments, she has successfully managed several companies and is involved in numerous philanthropic initiatives. With Dr. Kay's appointment, MannKind aims to enhance its strategic vision and leadership as it continues to develop its inhaled therapeutic products, including Afrezza.
MannKind Corporation (NASDAQ:MNKD) has successfully achieved the final development milestone under its collaboration with United Therapeutics for their dry powder formulation of treprostinil, a treatment for pulmonary arterial hypertension (PAH). All clinical trials are fully enrolled, including the BREEZE study and pivotal pharmacokinetics study. MannKind's stability program has met the requirements for a regulatory filing, paving the way for an FDA submission in early 2021. With all milestone payments received, MannKind will also earn royalties and manufacturing margins from TreT sales.
MannKind Corporation (NASDAQ:MNKD) reported third quarter 2020 results showing a net revenue of $15.4 million, comprising $7.3 million from Afrezza, an increase of 27% year-over-year. The company achieved a gross profit of $3.7 million, a significant recovery from a loss of $0.7 million in the same quarter of 2019. Cash and cash equivalents stood at $52.4 million as of September 30, 2020. The net loss for the quarter was $11.3 million or $0.05 per share, slightly higher than $10.4 million in Q3 2019. The company is on track to finalize Treprostinil Technosphere development by year-end.
MannKind Corporation (NASDAQ:MNKD) will announce its 2020 third quarter financial results on November 4, 2020, at 5:00 PM ET. CEO Michael Castagna and CFO Steven Binder will discuss the results and corporate updates during a conference call. Interested parties can listen live via the company's website or join a telephone replay available for 14 days post-call. MannKind specializes in inhaled therapeutic products, notably the FDA-approved Afrezza® inhalation powder, the only inhaled ultra-rapid acting mealtime insulin available in the U.S. and Brazil.