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30-week results from the Phase 4 INHALE-3 study expand upon the positive 17-week data presented earlier this year at the American Diabetes Association’s 84th Scientific SessionsSwitching to, or remaining on Afrezza allowed twice as many people to get to goal during the extension phase DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Sept. 30, 2024 (GLOBE NEWSWIRE) --  MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products and devices for p ...

Clearance to proceed also received from health authorities in South Korea and Australia, with Taiwan expected in 4Q 2024First U.S. patient randomized DANBURY, Conn., Sept. 18, 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 it has received clearance from Japan’s Pharmaceuticals and Medical Devices Agency (PM ...

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Sept. 10, 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 Chief Financial Officer Chris Prentiss and Dr. Wasim Fares Therapeutic Area Head, Orphan Lung Diseases, will share updates during a fireside chat at the 2024 Cantor Fitzgerald Global Healthcare Conference i ...

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Aug. 27, 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 Chief Executive Officer Michael Castagna, PharmD, and Chief Financial Officer Chris Prentiss will share updates during fireside chats at three upcoming investor conferences: 2024 Wells Fargo Healthcare Confe ...

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Aug. 14, 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 Kent Kresa has decided to retire from MannKind’s Board of Directors effective September 30, 2024. In addition, the Board of Directors has appointed Steven B. Binder to the Board, also effective September 30, ...

Financial Data and Key Metrics - Record revenue of $72 million in Q2 2024, a 49% increase YoY, with a GAAP net loss of $2 million and non-GAAP net income of $14 million [5] - Total revenue for the six-month period reached $139 million, a 55% increase YoY [14] - Cash and investments stood at $262 million at the end of Q2 2024, with a strong balance sheet and reduced debt [18] Business Line Performance - **Tyvaso DPI**: Contributed $26 million in Q2 revenue, a 34% increase YoY, driven by strong patient demand and new patient starts [15] - **Afrezza**: Q2 sales grew 20% YoY to $16.3 million, with 8% NRX growth leading to 5% TRX growth QoQ [10] - **V-GO**: Declined 7% to $4 million in Q2 2024, reflecting lower demand as the company focused on Afrezza [16] Market Performance - **NTM Market**: The refractory population represents 10%-20% of the market, with significant potential for clofazimine inhalation suspension [6] - **IPF Market**: A $4 billion market with OFEV as the backbone, offering opportunities for improved tolerability and efficacy [24] Strategic Direction and Industry Competition - The company is focused on advancing its pipeline, including clofazimine inhalation suspension and nintedanib DPI, with Phase 3 results expected in Q4 2024 [3][4] - The company is leveraging its Technosphere technology, with IP protection extending into the 2030s and 2040s [32] - Expansion of manufacturing capacity for Tyvaso DPI is underway, with high-speed fill/finish lines operational and spray drying capacity expected to be completed in Q3 2024 [21] Management Commentary on Operating Environment and Future Outlook - Management highlighted the strong progress in the first half of 2024, with significant revenue growth supporting pipeline development [18] - The company is optimistic about the future, with multiple data readouts expected in the coming quarters and years, particularly for Afrezza and Tyvaso DPI [22][25] Other Important Information - The company has orphan and QIDP designations for clofazimine, providing a minimum of 12 years of exclusivity [8] - The company is considering an expanded access program for clofazimine, pending FDA approval [49] Q&A Session Summary Question: IP and Revenue Runway for Pipeline Candidates - The company has strong IP protection for its Technosphere technology, extending into the 2030s and 2040s, with additional IP filed for clofazimine and OFEV [32] - For clofazimine, the company expects to have data from the first three dosing cohorts in Q4 2024, with plans to move to a Phase 2/3 design in 2025 [34] Question: Powering Assumptions for ICoN-1 Phase 3 Design - The ICoN-1 trial is powered at 90% for its six-month primary endpoint, with an interim analysis after 100 patients to assess futility [40] Question: Feedback on INHALE-3 Results and Impact on Afrezza Sales - Feedback from ADA on INHALE-3 results has been positive, with potential for increased growth in 2025, particularly with the pediatric launch [43] Question: Site Activation and Confidence in Clofazimine Program - Site activation for the clofazimine trial is progressing well, with pre-screening of patients underway and positive feedback from investigators [47] Question: Expanded Access Program for Clofazimine - The company is exploring an expanded access program for clofazimine, potentially for patients who do not qualify for the trial, pending FDA approval [49] Question: Phase 2/3 Trial Design for 201 and Manufacturing Capacity for Tyvaso DPI - The company is considering multiple dose levels for the Phase 2/3 trial of 201, with a focus on balancing efficacy, speed, and tolerability [53] - Manufacturing capacity for Tyvaso DPI is sufficient to meet demand, with no significant additional investment required [52]

For the quarter ended June 2024, MannKind (MNKD) reported revenue of $72.39 million, up 48.9% over the same period last year. EPS came in at $0.05, compared to $0.00 in the year-ago quarter.The reported revenue compares to the Zacks Consensus Estimate of $62.8 million, representing a surprise of +15.26%. The company delivered an EPS surprise of +400.00%, with the consensus EPS estimate being $0.01.While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street ex ...

MannKind (MNKD) came out with quarterly earnings of $0.05 per share, beating the Zacks Consensus Estimate of $0.01 per share. This compares to break-even earnings per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 400%. A quarter ago, it was expected that this biopharmaceutical company would post earnings of $0.02 per share when it actually produced earnings of $0.05, delivering a surprise of 150%.Over the last four quarters, the ...

EXHIBIT 99.1 mannkind MANNKIND CORPORATION REPORTS 2024 SECOND QUARTER FINANCIAL RESULTS: PROVIDES CLINICAL DEVELOPMENT UPDATE Conference Call to Begin Today at 9:00 a.m. (ET) • 2Q 2024 Total revenues of $72M; +49% vs. 2Q 2023 • YTD 2024 Total revenues of $139M; +55% vs. YTD 2023 • YTD 2024 Net income of $9 million; Non-GAAP net income of $29 million • Advances two orphan lung programs to human studies o MNKD-101 Phase 3 clinical trial activities initiated o MNKD-201 Phase 1 clinical trial on schedule to re ...