Reached enrollment goal of 305 patients living with Type 1 or Type 2 diabetesPrimary endpoint analysis expected in 4Q 2024 Data dissemination and FDA submission expected in 2025 DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Feb. 15, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, announced today that it has fully enrolled 305 patients living with type 1 ...

Core Viewpoint - MannKind's recent sale of a 10% stake in Tyvaso DPI for $150 million upfront, with potential additional payments, highlights the company's financial maneuvering despite a 14% decline in stock since October [1][9]. Financial Performance - MannKind reported a significant year-over-year revenue increase to $51.253 million from $32.825 million for Q3 2023, resulting in a profit of $1.721 million compared to a net loss previously [4]. - The company's liquidity improved with $144.3 million in assets, including $83 million in cash and equivalents, and a current ratio of 1.50, indicating sound short-term liquidity [5]. - The enterprise value of MannKind is estimated at $1.18 billion, with projections indicating revenue growth from $193.64 million in 2023 to $306.82 million by 2025 [2][6]. Market Position and Competition - Tyvaso DPI's sales reached $205 million in Q3 2023, up 225% year-over-year, with expectations of reaching $1.9 billion in trailing 12-month revenue by the end of 2026 [2]. - Liquidia's upcoming product YUTREPIA, which uses the same active ingredient as Tyvaso, may pose competitive pressure, but it is not expected to significantly impact Tyvaso's market share [3][9]. Market Sentiment - MannKind's market capitalization is approximately $946.21 million, with a high short interest of 13.31%, indicating bearish sentiment among investors [6][8]. - Institutional ownership stands at 50.47%, with mixed changes in holdings among major institutional investors, suggesting a cautious but engaged investor base [8]. Strategic Outlook - The recent Tyvaso DPI deal is seen as a positive step for MannKind, potentially leading to a reevaluation of its stock value [9]. - The company is committed to innovation, as evidenced by increased research and development spending, despite concerns over share dilution due to an increase in shares outstanding [4][5].

Financial Data and Key Metrics Changes - Total revenues grew 56% year-over-year in Q3 2023 and 121% for the nine months ended compared to the same period in 2022, driven by the launch of Tyvaso DPI and growth in the endocrine business [15][16] - The company achieved a net income of $2 million in Q3 2023, marking its first profitable quarter in history, compared to a net loss of $14 million in the same quarter last year [21][22] - The gross margin for commercial products was reported at 78%, an increase from previous quarters, attributed to improved efficiencies in Afrezza and V-Go products [34] Business Line Data and Key Metrics Changes - Tyvaso royalty revenue exceeded $20 million in Q3 2023, with collaboration services revenue of $13 million, reflecting strong patient demand [16][17] - The endocrine business generated total revenues of $18 million, with Afrezza net revenue increasing by 24% year-over-year to $13 million, driven by higher patient demand [17][18] - V-Go net revenue was $4 million in Q3 2023, an 18% decline compared to 2022, but the downward trend has stabilized [18] Market Data and Key Metrics Changes - The company reported a current run rate of over $200 million in revenues, with approximately 40% from royalties, which contribute directly to the bottom line [20] - The insulin market remains relatively flat to a small single-digit decline year-over-year, with Afrezza showing resilience against market changes [10] Company Strategy and Development Direction - The company is focused on expanding its pipeline, particularly in the orphan lung space and diabetes business, with significant progress in clinical trials for MannKind-101 and MannKind-201 [24][26] - The management emphasized the importance of capital allocation and deleveraging to enhance shareholder value while investing in growth drivers [26] - The company aims to leverage its manufacturing capacity to serve 25,000 to 35,000 patients annually, with potential to increase to 50,000 through efficiencies [8] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, highlighting the strong position of the company and the potential for growth in both the orphan lung and endocrine markets [23][24] - The management acknowledged the impact of GLP-1 medications on the diabetes market but maintained that the need for insulin, particularly for Type 1 diabetes patients, remains strong [36] - The company expects to continue seeing growth in revenues and patient demand, particularly for Tyvaso DPI, as out-of-pocket costs for patients are capped under Medicare [45] Other Important Information - The company has begun paying down its mid-cap debt and expects to manage cash flows tightly, with only a $2 million reduction in cash and investments in Q3 2023 [22] - The management is preparing for regulatory submissions and trial initiations in 2024, with a focus on maintaining momentum in clinical development [25][48] Q&A Session Summary Question: How will the INHALE trials shape the trajectory of Afrezza? - Management indicated that data from the INHALE trials will drive decisions regarding the commitment to the endocrine business and Afrezza, with expectations for improved efficacy and tolerability based on trial outcomes [30] Question: What are the economics of Tyvaso DPI? - The royalty rate for Tyvaso DPI is fixed at 10% on net sales, with collaboration services revenue on a cost-plus basis, leading to a margin of over 20% [31] Question: What is the outlook for gross margins? - The gross margin for commercial products was reported at 78%, with expectations for this level to be sustainable moving forward [34] Question: Is there any impact from GLP-1s on the diabetes business? - Management noted that while GLP-1s may slow growth in the diabetes market, they do not expect a significant impact on Afrezza, as Type 1 patients will still require insulin [36] Question: What are the next steps for IND submissions and trial designs? - The company is on track to file INDs for MannKind-101 and MannKind-201, with ongoing discussions with the FDA to streamline trial designs [48]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission file number: 000-50865 MannKind Corporation (Exact name of registrant as specified in its charter) Delaware 13-3607736 (State or other jurisdiction o ...

MannKind Corporation (NASDAQ:MNKD) Q2 2023 Earnings Conference Call August 7, 2023 5:00 PM ET Company Participants Michael Castagna - Chief Executive Officer Steve Binder - Chief Financial Officer Conference Call Participants Steven Lichtman - Oppenheimer & Company Olivia Brayer - Cantor Anish Nikhanj - RBC Capital Market Thomas Smith - Leerink Partners Oren Livnat - H.C. Wainwright Anthony Petrone - Mizuho Operator Good afternoon and welcome to MannKind Corporation 2023 Second Quarter Financial Results Ear ...

PART I: FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=2&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) MannKind Corporation's unaudited condensed consolidated financial statements for Q2 2023 and 2022 are presented, covering operations, balance sheets, and cash flows [Condensed Consolidated Statements of Operations](index=3&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Net loss significantly narrowed for Q2 2023, driven by a substantial increase in total revenues, primarily from collaborations Condensed Consolidated Statements of Operations (In thousands, except per share data) | | **Three Months Ended June 30,** | **Six Months Ended June 30,** | | :--- | :--- | :--- | | | **2023** | **2022** | **2023** | **2022** | | **Total revenues** | $48,611 | $18,894 | $89,237 | $30,886 | | **Total expenses** | $46,890 | $39,348 | $93,514 | $72,596 | | **Income (loss) from operations** | $1,721 | $(20,454) | $(4,277) | $(41,710) | | **Net loss** | $(5,265) | $(29,023) | $(15,060) | $(55,021) | | **Net loss per share – basic and diluted** | $(0.02) | $(0.11) | $(0.06) | $(0.22) | [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2023, total assets increased, total liabilities rose, and cash and cash equivalents improved, resulting in an increased stockholders' deficit Condensed Consolidated Balance Sheet Highlights (In thousands) | | **June 30, 2023** | **December 31, 2022** | | :--- | :--- | :--- | | **Cash and cash equivalents** | $86,184 | $69,767 | | **Total current assets** | $230,233 | $234,896 | | **Total assets** | $313,422 | $295,282 | | **Total current liabilities** | $96,966 | $67,296 | | **Total liabilities** | $573,909 | $545,820 | | **Total stockholders' deficit** | $(260,487) | $(250,538) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash from operating activities significantly improved for the six months ended June 30, 2023, contributing to an overall increase in cash and cash equivalents Cash Flow Summary (Six Months Ended June 30, In thousands) | | **2023** | **2022** | | :--- | :--- | :--- | | **Net cash provided by (used in) operating activities** | $3,752 | $(50,230) | | **Net cash provided by (used in) investing activities** | $17,456 | $(37,484) | | **Net cash used in financing activities** | $(4,791) | $(963) | | **Net increase (decrease) in cash and cash equivalents** | $16,417 | $(88,677) | | **Cash and cash equivalents, end of period** | $86,184 | $35,507 | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes detail the company's accounting policies and financial results, covering revenue recognition, product acquisitions, investments, debt, and significant commitments - The company's main commercial products are **Afrezza®** (insulin human) Inhalation Powder and the **V-Go®** wearable insulin delivery device. A key collaboration is with **United Therapeutics (UT)** for **Tyvaso DPI®**, for which MannKind receives royalties and manufacturing revenue[27](index=27&type=chunk) - In **May 2022**, the company acquired assets related to the **V-Go** wearable insulin delivery device from **Zealand Pharma** for up-front consideration of **$15.3 million** and potential sales-based milestones up to **$10.0 million**[82](index=82&type=chunk) - The collaboration with **United Therapeutics (UT)** for **Tyvaso DPI** is a major revenue driver, with three distinct performance obligations: **R&D Services and License**, **Next-Gen R&D Services**, and **Manufacturing Services**[45](index=45&type=chunk)[139](index=139&type=chunk) - The company has a significant insulin supply commitment with **Amphastar**, with remaining purchase commitments totaling approximately **€63.5 million** from **2023 through 2027**[179](index=179&type=chunk)[180](index=180&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=33&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial performance, highlighting significant revenue growth and a narrowed net loss, while affirming sufficient liquidity for the next twelve months [Results of Operations](index=35&type=section&id=Results%20of%20Operations_MD%26A) Total revenues for Q2 2023 surged **157%**, primarily driven by collaboration royalties and services related to Tyvaso DPI, alongside growth in commercial product sales Revenue Comparison (in thousands) | | **Three Months Ended June 30,** | **Six Months Ended June 30,** | | :--- | :--- | :--- | | | **2023** | **2022** | **% Change** | **2023** | **2022** | **% Change** | | **Net revenue – commercial product sales** | $18,345 | $12,722 | 44% | $35,907 | $22,548 | 59% | | **Revenue – collaborations and services** | $11,211 | $5,868 | 91% | $22,597 | $8,034 | 181% | | **Royalties – collaborations** | $19,055 | $304 | * | $30,733 | $304 | * | | **Total revenues** | **$48,611** | **$18,894** | **157%** | **$89,237** | **$30,886** | **189%** | - **Afrezza** net revenue increased by **27%** for the three months ended **June 30, 2023**, compared to the prior year, driven by higher product demand and price[202](index=202&type=chunk) - **V-Go**, acquired in **May 2022**, contributed significantly to revenue growth, with net revenue increasing **132%** for the three months ended **June 30, 2023**, compared to the same period in the prior year[205](index=205&type=chunk) - **R&D expenses** increased **32%** in **Q2 2023** YoY due to development activities for **MNKD-101** (inhaled clofazimine) and the **Afrezza INHALE-3 study**[214](index=214&type=chunk) - **Selling expenses** decreased **12%** in **Q2 2023** YoY, primarily due to the termination of a pilot promotional effort for **Afrezza** targeting primary care physicians[214](index=214&type=chunk) [Liquidity and Capital Resources](index=39&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity is supported by cash, equivalents, and investments, deemed sufficient for the next twelve months despite significant outstanding debt and purchase commitments - The company believes it has **sufficient liquidity** to fund operations for the **next twelve months** based on cash on hand, investments, and projected revenues[225](index=225&type=chunk)[234](index=234&type=chunk) Outstanding Debt Principal as of June 30, 2023 | Debt Instrument | Principal Amount | | :--- | :--- | | Senior convertible notes | $230.0 million | | MidCap credit facility | $40.0 million | | Mann Group convertible note | $8.8 million | | **Total** | **$278.8 million** | - For the six months ended **June 30, 2023**, the company generated **$3.8 million** in cash from operations, a significant improvement from the **$50.2 million** used in the prior-year period[229](index=229&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=40&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces market risks primarily from interest rate fluctuations on variable-rate debt and foreign currency exposure from Euro-denominated purchase obligations - Interest rate risk is linked to the **MidCap credit facility's** variable rate (**SOFR-based**), while other major debt instruments have fixed rates[237](index=237&type=chunk) - The company has significant foreign currency exchange risk due to its insulin supply agreement with **Amphastar**, which has obligations denominated in **Euros**. For the six months ended **June 30, 2023**, a **$1.2 million** currency loss was realized[240](index=240&type=chunk) - A hypothetical **10%** change in the U.S. dollar to Euro exchange rate as of **June 30, 2023**, would result in a foreign currency impact of approximately **$6.9 million** to the pre-tax loss[241](index=241&type=chunk) [Item 4. Controls and Procedures](index=40&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2023, with no material changes to internal control over financial reporting during the quarter - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were **effective** as of **June 30, 2023**[243](index=243&type=chunk) - **No material changes** to the internal control over financial reporting were identified during the latest fiscal quarter[245](index=245&type=chunk) PART II: OTHER INFORMATION [Item 1. Legal Proceedings](index=42&type=section&id=Item%201.%20Legal%20Proceedings) The company is subject to ordinary course legal proceedings, which management believes will not materially adversely affect its financial position or results - The company states that it is **not involved** in any legal proceedings that are expected to have a **material adverse effect** on its financial condition[247](index=247&type=chunk) [Item 1A. Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) This section details significant business, operational, and financial risks, including product commercialization, supply chain, regulatory compliance, capital needs, and cybersecurity threats - **Business Risks:** The company faces risks of **limited commercial success** for its products, manufacturing challenges, reliance on **single-source suppliers** like **Amphastar** for insulin, and the need to raise **additional capital** despite a **history of losses**[250](index=250&type=chunk)[256](index=256&type=chunk)[266](index=266&type=chunk) - **Regulatory Risks:** The business is subject to **stringent government regulation**, including ongoing compliance with **cGMP**, potential for **healthcare reform** to impact pricing and reimbursement, and complex data privacy laws like **GDPR** and **CCPA**[253](index=253&type=chunk)[347](index=347&type=chunk)[362](index=362&type=chunk) - **Financial Risks:** The company may **not generate sufficient cash** to service its **significant debt and commitments**. Its stock price is **volatile**, and future equity or debt financing could be **dilutive** to existing shareholders[284](index=284&type=chunk)[394](index=394&type=chunk)[404](index=404&type=chunk) - **Operational Risks:** The company's IT systems are **vulnerable to cyber-attacks**, and a **fire** at a contract manufacturer's facility for an investigational product (**MNKD-101**) is expected to cause a **3-6 month delay** in clinical supply production[297](index=297&type=chunk)[327](index=327&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=70&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) In April 2023, the company issued common stock to the Mann Group LLC for interest payment on a convertible note, exempt from registration - In **April 2023**, the company issued **13,192 shares** of common stock to the Mann Group LLC to pay approximately **$0.1 million** in quarterly interest on the **Mann Group convertible note**[410](index=410&type=chunk) [Item 5. Other Information](index=70&type=section&id=Item%205.%20Other%20Information) An executive officer adopted a Rule 10b5-1 trading plan in Q2 2023 for the sale of common stock, set to expire in May 2024 - An executive officer adopted a **Rule 10b5-1 trading plan** on **May 24, 2023**, to sell **384,020 shares** of common stock over the following year[411](index=411&type=chunk)[413](index=413&type=chunk)

MannKind Corporation (NASDAQ:MNKD) Q1 2023 Earnings Conference Call May 9, 2023 5:00 PM ET Company Participants Michael Castagna - CEO Steven Binder - CFO Conference Call Participants Oren Livnat - H.C. Wainwright Brandon Folkes - Cantor Fitzgerald Anish Nikhanj - RBC Capital Markets Thomas Smith - SVB Securities Steven Lichtman - Oppenheimer Anthony Petrone - Mizuho Operator Good afternoon. And welcome to the MannKind Corporation 2023 First Quarter Financial Results Earnings Call. As a reminder this call i ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission file number: 000-50865 MannKind Corporation (Exact name of registrant as specified in its charter) Delaware 13-3607736 (State or other jurisdiction of in ...

Oppenheimer 33rd Annual Healthcare Conference Michael Castagna, PharmD Chief Executive Officer March 14, 2023 NASDAQ: MNKD 1 © Copyright 2023. All rights reserved. MannKind Corporation. / 15 March 2023 Cautionary Statement Today's presentation includes forward-looking statements relating to the development, commercialization and benefits of our products and investigational product candidates, including AFREZZA®, that are subject to certain risks and uncertainties that could cause actual results to differ ma ...

MannKind Corporation (NASDAQ:MNKD) Q4 2022 Results Conference Call February 23, 2023 5:00 PM ET Company Participants Michael Castagna - Chief Executive Officer Steven Binder - Chief Financial Officer Conference Call Participants Brandon Folkes - Cantor Gregory Renza - RBC Mike Kratky - SVB Operator Good afternoon, and welcome to the MannKind Corporation 2022 Fourth Quarter and Full Year Financial Results Earnings Call. As a reminder, this call is being recorded on February 23, 2023 and will be available for ...