MannKind(MNKD)

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MannKind Announces IND Clearance From U.S. FDA to Start Phase 3 Study of Clofazimine Inhalation Suspension for Nontuberculous Mycobacterial (NTM) Lung Disease
Newsfilter· 2024-04-29 10:05
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., April 29, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced today that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for MNKD-101 (Clofazimine Inhalation Suspension), enabling the initiation of a Phase 3 study f ...
MannKind Repays Certain Debt Obligations
Newsfilter· 2024-04-03 10:00
Core Viewpoint - MannKind Corporation has successfully repaid all outstanding debts under its credit agreement with MidCap Financial Trust and a convertible note issued to Mann Group LLC, significantly reducing its total debt by approximately $41.8 million since December 31, 2023 [1][2][3] Debt Repayment Details - On April 1, 2024, MannKind made a payment of approximately $31.6 million to fully satisfy its obligations under the Loan Agreement, which included an exit fee of $2.8 million and a prepayment fee of approximately $0.3 million [2] - The repayment resulted in the automatic termination of all liens, mortgages, and security interests related to the Loan Agreement, releasing MannKind and its subsidiaries from all guarantees [2] - On April 2, 2024, MannKind satisfied its obligations under the convertible note by paying approximately $8.9 million and issuing 1.5 million shares of common stock, fully terminating all obligations under the Note [3] Management Commentary - The CEO of MannKind stated that repaying the MidCap loan eliminates the company's most expensive debt and releases its assets from security interests, which is a strategic move for future financial flexibility [3] - The CEO also expressed the belief that the company's stock price is currently undervalued, leading to the decision to repay the Mann Group debt through a partial conversion to reduce future potential dilution by over two million shares [3] Company Overview - MannKind Corporation focuses on developing and commercializing innovative therapeutic products and devices for patients with endocrine and orphan lung diseases [4] - The company aims to address serious unmet medical needs using its formulation capabilities and device engineering, particularly for conditions like diabetes and pulmonary arterial hypertension [4] - MannKind's technologies include dry-powder formulations and inhalation devices that provide rapid and convenient delivery of medicines [4]
INHALE-3 Study's Initial Meal Challenge Results Comparing Afrezza® Head-To-Head With Multiple Daily Injections (MDI) and Insulin Pumps
Newsfilter· 2024-03-11 10:05
Post-meal hyperglycemia was significantly reduced by 20% with inhaled insulin compared with rapid-acting insulin delivered through MDI or insulin pumpsSubjects utilizing inhaled insulin experienced a 22% decrease in mean glucose excursions in the first two hours compared to the standard of care17-week primary endpoint results will be presented during a 90-minute symposium at the American Diabetes Association's Scientific Sessions in June DANBURY, Conn. and WESTLAKE VILLAGE, Calif., March 11, 2024 (GLOBE NEW ...
MannKind Announces New Clinical Data From Inhale-3 Study to be Presented by Dr. Irl B. Hirsch at ATTD on March 8
Newsfilter· 2024-03-05 11:05
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., March 05, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD), a company focused on the development and commercialization of inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced today that new clinical data from the INHALE-3 study first meal challenge will be presented at the upcoming 17th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD) in Florence on March 6-9. INHAL ...
MannKind Corporation Announces Participation at Upcoming Conferences
Newsfilter· 2024-03-04 18:01
WESTLAKE VILLAGE, Calif. and DANBURY, Conn., March 04, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD), a company focused on the development and commercialization of inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced today that it will be participating at upcoming conferences. Leerink Partners Global Biopharma Conference 2024 – Investor Meetings, Monday, March 11, 2024 Oppenheimer 34th Annual Healthcare MedTech & Services Conference – Corpora ...
MannKind Corporation Announces Participation at Upcoming Conferences
Globenewswire· 2024-03-04 18:01
WESTLAKE VILLAGE, Calif. and DANBURY, Conn., March 04, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced today that it will be participating at upcoming conferences. Leerink Partners Global Biopharma Conference 2024 – Investor Meetings, Monday, March 11, 2024 Oppenheimer 34th Annual Healthcare MedTech & Services Conference – Corpor ...
MannKind(MNKD) - 2023 Q4 - Earnings Call Transcript
2024-02-28 03:33
MannKind Corporation (NASDAQ:MNKD) Q4 2023 Earnings Conference Call February 27, 2024 5:00 PM ET Company Participants Michael Castagna - Chief Executive Officer Steven Binder - Chief Financial Officer Conference Call Participants Andreas Argyrides - Wedbush Securities Olivia Brayer - Cantor Fitzgerald Steven Lichtman - Oppenheimer and Company Oren Livnat - H.C. Wainwright Thomas Smith - Leerink Partners Anthony Petrone - Mizuho Group Operator Good afternoon and welcome to MannKind Corporation 2023 Fourth Qu ...
Here's What Key Metrics Tell Us About MannKind (MNKD) Q4 Earnings
Zacks Investment Research· 2024-02-28 00:01
For the quarter ended December 2023, MannKind (MNKD) reported revenue of $58.47 million, up 62.2% over the same period last year. EPS came in at $0.02, compared to -$0.07 in the year-ago quarter.The reported revenue represents a surprise of +11.67% over the Zacks Consensus Estimate of $52.36 million. With the consensus EPS estimate being -$0.01, the EPS surprise was +300.00%.While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compare to Wall Stree ...
MannKind (MNKD) Q4 Earnings and Revenues Surpass Estimates
Zacks Investment Research· 2024-02-27 23:36
Company Performance - MannKind reported quarterly earnings of $0.02 per share, exceeding the Zacks Consensus Estimate of a loss of $0.01 per share, and improved from a loss of $0.07 per share a year ago, representing an earnings surprise of 300% [1] - The company achieved revenues of $58.47 million for the quarter ended December 2023, surpassing the Zacks Consensus Estimate by 11.67%, and up from $36.06 million in the same quarter last year [1] - Over the last four quarters, MannKind has consistently surpassed consensus EPS and revenue estimates [1] Future Outlook - The sustainability of MannKind's stock price movement will largely depend on management's commentary during the earnings call and future earnings expectations [2] - Current consensus EPS estimate for the upcoming quarter is $0.01 on revenues of $53.4 million, and for the current fiscal year, it is $0.06 on revenues of $236.57 million [4] - The estimate revisions trend for MannKind is mixed, resulting in a Zacks Rank 3 (Hold), indicating expected performance in line with the market [4] Industry Context - MannKind operates within the Medical - Biomedical and Genetics industry, which is currently ranked in the top 32% of over 250 Zacks industries, suggesting a favorable industry outlook [5] - The performance of MannKind's stock may also be influenced by the overall industry outlook, as the top 50% of Zacks-ranked industries tend to outperform the bottom 50% by more than 2 to 1 [5] - Zymeworks Inc., another company in the same industry, is expected to report a quarterly loss of $0.39 per share, reflecting a year-over-year change of -108.4%, with revenues anticipated to be $18.32 million, down 95.5% from the previous year [5][6]
MannKind(MNKD) - 2023 Q4 - Annual Results
2024-02-26 16:00
EXHIBIT 99.1 mannkind MANNKIND CORPORATION REPORTS 2023 FOURTH QUARTER AND FULL YEAR FINANCIAL RESULTS: PROVIDES CLINICAL DEVELOPMENT UPDATE Conference Call to Begin Today at 5:00 p.m. (ET) • 2023 Total revenues of $199M; +99% vs. 2022 • 4Q 2023 Total revenues of $58M; +62% vs. 2022 • 4Q 2023 Net income of $1M; Non-GAAP net income of $7M • $302M of cash and cash equivalents and investments at December 31, 2023 DANBURY, Conn. and WESTLAKE VILLAGE, Calif. February 27, 2024 (Globe Newswire) — MannKind Corporat ...