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 ...

Financial Data and Key Metrics Changes - Total revenues for 2023 doubled compared to 2022, reaching nearly $200 million, with a 62% increase in Q4 2023 versus Q4 2022 [23][24] - Tyvaso DPI royalty revenue for Q4 was $21 million, a 132% increase year-over-year, while full-year royalty revenue reached $72 million, up 361% from 2022 [24][25] - The endocrine business unit reported total revenues of $20 million for Q4 and $74 million for the full year, with Afrezza's net revenue growing 27% year-over-year [25][26] Business Line Data and Key Metrics Changes - The endocrine business unit contributed approximately 37% of total revenue in 2023, with Afrezza net revenue increasing by $12 million or 27% year-over-year, marking the largest jump in seven years [5][7][25] - V-Go net revenue for Q4 was $5 million, a 13% decrease from 2022, primarily due to lower patient demand [26] Market Data and Key Metrics Changes - The Endocrine business grew 32% year-over-year, contributing $20 million in Q4 and a run rate of $80 million [6][25] - The company anticipates significant market potential expansion with several clinical readouts expected in 2024 [7][10] Company Strategy and Development Direction - The company aims to drive shareholder value by focusing on operational opportunities and maintaining a strong financial position, having sold a portion of Tyvaso royalty for $150 million [4][5] - The Endocrine business is seen as a core pillar for future growth, with plans to optimize sales force capabilities and enhance prescriber adoption [8][9] - The company is also focusing on expanding its pipeline with new clinical trials for MNKD-101 and MNKD-201, targeting significant market opportunities in NTM and IPF [16][20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, highlighting the company's strong financial position and the potential for double-digit growth in the endocrine business [5][6] - The management emphasized the importance of upcoming clinical data from INHALE-1 and INHALE-3 trials, which are expected to drive future growth [10][12] Other Important Information - The company ended 2023 with $302 million in cash and investments, positioning itself well for future investments in clinical trials and debt reduction [37][38] - The company has restructured its insulin purchase commitments, reducing near-term cash outlay by $50 million [5] Q&A Session Summary Question: Can you elaborate on the differences with the DPI device compared with competitors? - The DPI device offers advantages in ease of use and safety, with a focus on deep lung penetration and minimal powder containment, which enhances patient satisfaction and dosing consistency [46][48] Question: How does NTM fit into your strategic priorities? - The company plans to target refractory patients first and is exploring partnerships for international licensing, while also developing a dry powder version for earlier treatment lines [51][52] Question: What data will be presented at ATTD? - The presentation will include first dose and meal tolerance data for Afrezza, aiming to highlight its advantages in treatment [54][55] Question: How is the sales force being optimized? - The company is reallocating resources to create key account managers and reimbursement specialists to enhance future growth capabilities [56]

Core Insights - MannKind reported revenue of $58.47 million for the quarter ended December 2023, marking a 62.2% increase year-over-year [1] - The earnings per share (EPS) was $0.02, a significant improvement from -$0.07 in the same quarter last year [1] - The revenue exceeded the Zacks Consensus Estimate of $52.36 million by 11.67%, while the EPS surpassed the consensus estimate of -$0.01 by 300% [1] Revenue Breakdown - Royalties and collaborations revenue reached $21.03 million, exceeding the average estimate of $19.25 million by analysts, representing a 120.3% increase year-over-year [2] - Revenue from collaborations and services was $17.25 million, surpassing the average estimate of $15.46 million [2] - Net revenue from commercial product sales was $20.20 million, compared to the average estimate of $19.42 million, reflecting a 15.8% year-over-year change [2] Stock Performance - MannKind shares have returned +1.7% over the past month, while the Zacks S&P 500 composite increased by +3.8% [2] - The stock currently holds a Zacks Rank 3 (Hold), indicating potential performance in line with the broader market in the near term [2]

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]

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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 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 incorpora ...

Core Insights - MannKind Corporation has successfully enrolled 305 patients with type 1 or type 2 diabetes in its INHALE-1 study, which focuses on the efficacy and safety of inhaled insulin in the pediatric population [1][2] - The primary endpoint analysis is anticipated to be completed in the fourth quarter of 2024, with data dissemination and FDA submission expected in 2025 [1][3] Company Overview - MannKind Corporation specializes in the development and commercialization of innovative therapeutic products for endocrine and orphan lung diseases, utilizing dry-powder formulations and inhalation devices for effective drug delivery [4] - The company aims to address serious unmet medical needs, particularly in diabetes management, pulmonary arterial hypertension, and nontuberculous mycobacterial lung disease [4] Study Details - The INHALE-1 study is a 26-week open-label, randomized clinical trial with a 26-week extension, focusing on the change in HbA1c levels as the primary endpoint [2] - Secondary endpoints include changes in fasting plasma glucose and the rate of hypoglycemic events, comparing Afrezza in combination with basal insulin against multiple daily injections of insulin in children and adolescents aged 4-17 [2]

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]

[PART I: FINANCIAL INFORMATION](index=2&type=section&id=PART%20I%3A%20FINANCIAL%20INFORMATION) This section provides MannKind Corporation's unaudited condensed consolidated financial statements and management's discussion and analysis for the reporting period [Item 1. Financial Statements (Unaudited)](index=2&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Presents MannKind Corporation's unaudited condensed consolidated financial statements and related notes, detailing financial position and performance [Condensed Consolidated Statements of Operations](index=3&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported a net income of $1.7 million for Q3 2023, with significant revenue growth driven by collaborations and royalties Total Revenues (in thousands) | Period | 2023 (in thousands) | 2022 (in thousands) | Change (YoY) | % Change (YoY) | | :----- | :------------------ | :------------------ | :----------- | :------------- | | 3 Months Ended Sep 30 | $51,253 | $32,825 | $18,428 | 56% | | 9 Months Ended Sep 30 | $140,490 | $63,711 | $76,779 | 121% | Net Income (Loss) (in thousands) | Period | 2023 (in thousands) | 2022 (in thousands) | Change (YoY) | | :----- | :------------------ | :------------------ | :----------- | | 3 Months Ended Sep 30 | $1,721 | $(14,432) | $16,153 | | 9 Months Ended Sep 30 | $(13,339) | $(69,453) | $56,114 | Basic and Diluted EPS | Period | 2023 | 2022 | | :----- | :--- | :--- | | 3 Months Ended Sep 30 | $0.01 | $(0.06) | | 9 Months Ended Sep 30 | $(0.05) | $(0.27) | [Condensed Consolidated Statements of Comprehensive Income (Loss)](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Income%20(Loss)) Comprehensive income improved to $1.7 million for Q3 2023, with a reduced nine-month loss partly due to unrealized gains Comprehensive Income (Loss) (in thousands) | Period | 2023 (in thousands) | 2022 (in thousands) | | :----- | :------------------ | :------------------ | | 3 Months Ended Sep 30 | $1,721 | $(14,432) | | 9 Months Ended Sep 30 | $(12,896) | $(70,659) | - Unrealized gain (loss) on available-for-sale securities (9 months ended Sep 30): **$443 thousand in 2023** vs. **$(1,206) thousand in 2022**[11](index=11&type=chunk) [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets increased to $320.3 million, driven by property and equipment, while liabilities and stockholders' deficit also rose Balance Sheet Summary (in thousands) | Metric | Sep 30, 2023 (in thousands) | Dec 31, 2022 (in thousands) | Change | | :----- | :-------------------------- | :-------------------------- | :----- | | Total Assets | $320,328 | $295,282 | +$25,046 | | Total Liabilities | $572,107 | $545,820 | +$26,287 | | Total Stockholders' Deficit | $(251,779) | $(250,538) | $(1,241) | - Cash and Cash Equivalents: Increased to **$83.0 million** as of Sep 30, 2023, from **$69.8 million** as of Dec 31, 2022[14](index=14&type=chunk) - Property and Equipment, net: Increased to **$80.4 million** as of Sep 30, 2023, from **$45.1 million** as of Dec 31, 2022[14](index=14&type=chunk) [Condensed Consolidated Statements of Stockholders' Deficit](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Deficit) Stockholders' deficit slightly increased to $(251.8) million, influenced by net loss and stock issuances, partially offset by gains Stockholders' Deficit (in thousands) | Date | Amount (in thousands) | | :--- | :-------------------- | | Jan 1, 2023 | $(250,538) | | Sep 30, 2023 | $(251,779) | - Common Shares Outstanding: Increased from **263,793 thousand** at Jan 1, 2023, to **269,543 thousand** at Sep 30, 2023[19](index=19&type=chunk) - Additional Paid-in Capital: Increased by **$11.6 million** during the nine months ended Sep 30, 2023[19](index=19&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Operating activities generated **$12.4 million** cash for the nine months, a significant improvement, with investing providing cash and financing using cash Net Cash from Operating Activities (in thousands) | Period | 2023 (in thousands) | 2022 (in thousands) | | :----- | :------------------ | :------------------ | | 9 Months Ended Sep 30 | $12,416 | $(78,303) | Net Cash from Investing Activities (in thousands) | Period | 2023 (in thousands) | 2022 (in thousands) | | :----- | :------------------ | :------------------ | | 9 Months Ended Sep 30 | $5,907 | $(10,136) | Net Cash from Financing Activities (in thousands) | Period | 2023 (in thousands) | 2022 (in thousands) | | :----- | :------------------ | :------------------ | | 9 Months Ended Sep 30 | $(5,074) | $18,563 | - Cash and Cash Equivalents, End of Period: Increased to **$83.0 million** as of Sep 30, 2023, from **$54.3 million** as of Sep 30, 2022[22](index=22&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Provides detailed explanations and disclosures for the financial statements, covering business, accounting policies, and key financial components [1. Description of Business and Significant Accounting Policies](index=10&type=section&id=1.%20Description%20of%20Business%20and%20Significant%20Accounting%20Policies) MannKind is a biopharmaceutical company focused on endocrine and orphan lung diseases, detailing key accounting policies including revenue recognition - Business Focus: Development and commercialization of innovative therapeutic products and devices for endocrine and orphan lung diseases, utilizing Technosphere dry-powder formulations and Dreamboat inhalation devices[28](index=28&type=chunk) - Key Products: Afrezza (inhaled insulin), V-Go (wearable insulin delivery device), and Tyvaso DPI (treprostinil inhalation powder, commercialized by United Therapeutics)[28](index=28&type=chunk) - Revenue Recognition: Recognizes revenue when customers obtain control of goods/services, applying a five-step model for contracts. Commercial product sales are net of variable consideration (rebates, discounts, returns). Collaboration revenue is recognized based on performance obligations and stand-alone selling prices[31](index=31&type=chunk)[32](index=32&type=chunk)[36](index=36&type=chunk) Net Revenue by Type (in thousands) | Revenue Type | 3 Months Ended Sep 30, 2023 (in thousands) | 3 Months Ended Sep 30, 2022 (in thousands) | 9 Months Ended Sep 30, 2023 (in thousands) | 9 Months Ended Sep 30, 2022 (in thousands) | | :----------- | :----------------------------------------- | :----------------------------------------- | :----------------------------------------- | :----------------------------------------- | | Product sales | $30,727 | $26,175 | $88,731 | $54,602 | | Services | $308 | $430 | $808 | $2,585 | | Royalties | $20,218 | $6,220 | $50,951 | $6,524 | | **Total Net Revenue** | **$51,253** | **$32,825** | **$140,490** | **$63,711** | [2. Acquisition](index=18&type=section&id=2.%20Acquisition) MannKind acquired V-Go in May 2022 for **$15.3 million** upfront, with potential **$10.0 million** in sales-based milestones - V-Go Acquisition Date: May 2022[87](index=87&type=chunk) - Up-front Consideration: **$15.3 million** cash[87](index=87&type=chunk) - Contingent Milestone Payments: Up to **$10.0 million** based on annual revenue milestones ($40M-$100M)[87](index=87&type=chunk) - Goodwill: **$1.9 million** as of September 30, 2023, adjusted for rebate-related liabilities and inventory obsolescence[110](index=110&type=chunk) [3. Investments](index=20&type=section&id=3.%20Investments) Investments include Thirona convertible notes and debt securities, with the fair value of Thirona notes increasing to **$8.4 million** - Fair Value of Thirona Convertible Notes: **$8.4 million** as of Sep 30, 2023 (vs. **$7.1 million** as of Dec 31, 2022)[95](index=95&type=chunk) Interest Income from Held-to-Maturity Investments (in thousands) | Period | 2023 (in thousands) | 2022 (in thousands) | | :----- | :------------------ | :------------------ | | 3 Months Ended Sep 30 | $1,000 | $700 | | 9 Months Ended Sep 30 | $3,200 | $1,600 | Held-to-Maturity Debt Securities by Maturity (in thousands) | Maturity | Sep 30, 2023 (in thousands) | Dec 31, 2022 (in thousands) | | :------- | :-------------------------- | :-------------------------- | | One year or less | $126,616 | $152,862 | | After one year through five years | $3,271 | $1,961 | | **Total** | **$129,887** | **$154,823** | [4. Accounts Receivable](index=21&type=section&id=4.%20Accounts%20Receivable) Total accounts receivable, net, increased to **$21.8 million**, primarily in collaboration and services receivables, with high concentration among distributors - Total Accounts Receivable, Net: **$21.8 million** as of Sep 30, 2023 (vs. **$16.8 million** as of Dec 31, 2022)[103](index=103&type=chunk) - Accounts Receivable – Collaborations and Services: Increased to **$11.2 million** as of Sep 30, 2023 (vs. **$4.1 million** as of Dec 31, 2022)[103](index=103&type=chunk) - Concentration: Three wholesale distributors represented **~79%** of commercial accounts receivable as of Sep 30, 2023. United Therapeutics comprised **100%** of collaboration and services net accounts receivable[103](index=103&type=chunk)[104](index=104&type=chunk) [5. Inventories](index=21&type=section&id=5.%20Inventories) Total inventory increased to **$27.1 million**, driven by finished goods, with **$3.7 million** in inventory write-offs for the nine months - Total Inventory: **$27.1 million** as of Sep 30, 2023 (vs. **$21.8 million** as of Dec 31, 2022)[105](index=105&type=chunk) - Finished Goods: Increased to **$8.8 million** as of Sep 30, 2023 (vs. **$2.2 million** as of Dec 31, 2022)[105](index=105&type=chunk) - Inventory Write-offs: **$3.7 million** for the nine months ended Sep 30, 2023 (vs. **$1.4 million** in 2022)[106](index=106&type=chunk) [6. Property and Equipment](index=22&type=section&id=6.%20Property%20and%20Equipment) Total property and equipment, net, significantly increased to **$80.4 million**, primarily due to construction in progress, with higher depreciation expense - Total Property and Equipment, Net: **$80.4 million** as of Sep 30, 2023 (vs. **$45.1 million** as of Dec 31, 2022)[108](index=108&type=chunk) - Construction in Progress: **$48.3 million** as of Sep 30, 2023 (vs. **$16.7 million** as of Dec 31, 2022)[108](index=108&type=chunk) - Depreciation Expense (9 months ended Sep 30): **$3.3 million** in 2023 (vs. **$2.3 million** in 2022)[109](index=109&type=chunk) [7. Goodwill and Other Intangible Asset](index=22&type=section&id=7.%20Goodwill%20and%20Other%20Intangible%20Asset) Goodwill from the V-Go acquisition was **$1.9 million**, with other intangible assets having a net book value of **$1.1 million** - Goodwill Balance: **$1.9 million** as of Sep 30, 2023 (vs. **$2.4 million** as of Dec 31, 2022)[110](index=110&type=chunk) - Other Intangible Asset (Developed Technology): Net Book Value of **$1.093 million** as of Sep 30, 2023[111](index=111&type=chunk) - Estimated Annual Amortization: Approximately **$0.1 million** per year for the other intangible asset through 2027[112](index=112&type=chunk) [8. Accrued Expenses and Other Current Liabilities](index=23&type=section&id=8.%20Accrued%20Expenses%20and%20Other%20Current%20Liabilities) Accrued expenses and other current liabilities decreased to **$32.1 million**, including salary expenses and commercial product discounts - Total Accrued Expenses and Other Current Liabilities: **$32.1 million** as of Sep 30, 2023 (vs. **$35.6 million** as of Dec 31, 2022)[114](index=114&type=chunk) - Discounts and Allowances for Commercial Product Sales: **$9.9 million** as of Sep 30, 2023 (vs. **$8.5 million** as of Dec 31, 2022)[114](index=114&type=chunk) [9. Borrowings](index=23&type=section&id=9.%20Borrowings) Total debt carrying amount was **$273.2 million**, primarily Senior convertible notes (**$230.0 million**) and MidCap credit facility (**$38.3 million**) - Total Debt – Net Carrying Amount: **$273.2 million** as of Sep 30, 2023 (vs. **$273.5 million** as of Dec 31, 2022)[116](index=116&type=chunk) Debt Summary (as of Sep 30, 2023) | Debt Type | Amount (Sep 30, 2023) | Annual Interest Rate | Maturity Date | Conversion Price | | :-------- | :-------------------- | :------------------- | :------------ | :--------------- | | Senior convertible notes | $230.0 million | 2.50% | March 2026 | $5.21 per share | | MidCap credit facility | $38.3 million | One-month SOFR (1% floor) + 6.25%; cap of 8.25% | August 2025 | N/A | | Mann Group convertible note | $8.8 million | 2.50% | December 2025 | $2.50 per share | Future Principal Payments on Debt (in thousands) | Year | Amount (in thousands) | | :--- | :-------------------- | | 2023 | $5,000 | | 2024 | $20,000 | | 2025 | $22,163 | | 2026 | $230,000 | | **Total** | **$277,163** | [10. Collaboration, Licensing and Other Arrangements](index=27&type=section&id=10.%20Collaboration%2C%20Licensing%20and%20Other%20Arrangements) Collaboration revenue significantly increased to **$86.5 million** from United Therapeutics, with deferred revenue rising to **$71.7 million** Revenue from United Therapeutics (in thousands) | Period | 2023 (in thousands) | 2022 (in thousands) | | :----- | :------------------ | :------------------ | | 3 Months Ended Sep 30 | $33,289 | $16,529 | | 9 Months Ended Sep 30 | $86,546 | $24,268 | - Deferred Revenue: **$71.7 million** as of Sep 30, 2023 (vs. **$37.9 million** as of Dec 31, 2022), with **$3.5 million** current and **$68.2 million** long-term[146](index=146&type=chunk) - UT CSA Agreement Revenue Allocation: Total anticipated cash flow of **$722.3 million**, with **$10.0 million** for Next-Gen R&D Services and **$712.3 million** for Manufacturing Services and Product Sales[145](index=145&type=chunk) - Thirona Collaboration: Amended to extend term through June 2024, with MannKind funding a minimum of **$1.1 million** for development[147](index=147&type=chunk) [11. Fair Value of Financial Instruments](index=29&type=section&id=11.%20Fair%20Value%20of%20Financial%20Instruments) Fair values of financial liabilities, including Senior convertible notes (**$237.3 million**) and Milestone Rights (**$11.7 million**), are determined using Level 3 inputs Fair Value of Financial Liabilities (in thousands) | Financial Liability | Carrying Amount (in thousands) | Fair Value (in thousands) | | :------------------ | :----------------------------- | :------------------------ | | Senior convertible notes | $226,487 | $237,293 | | MidCap credit facility | $37,921 | $40,032 | | Mann Group convertible note | $8,829 | $15,857 | | Milestone rights | $3,914 | $11,700 | | Contingent milestone liability | $610 | $610 | | Financing liability | $104,122 | $99,940 | - Valuation Method: Fair values determined using discounted cash flow analysis and Monte Carlo simulation, primarily with Level 3 inputs[153](index=153&type=chunk) [12. Common and Preferred Stock](index=30&type=section&id=12.%20Common%20and%20Preferred%20Stock) Authorized common stock increased to **800 million** shares, with **269.5 million** outstanding, including shares issued via ATM offerings and for note interest - Authorized Common Stock: Increased from **400 million** to **800 million** shares in May 2023[158](index=158&type=chunk) - Common Shares Outstanding: **269,543,539** as of Sep 30, 2023 (vs. **263,793,305** as of Dec 31, 2022)[158](index=158&type=chunk) - At-the-Market Offerings (9 months ended Sep 30, 2023): Sold **1,478,090 shares** for **$6.9 million** gross proceeds[159](index=159&type=chunk) - Mann Group Convertible Note Interest: Issued **37,122 common shares** for interest payments during the nine months ended Sep 30, 2023[160](index=160&type=chunk) [13. Earnings per Common Share ("EPS")](index=30&type=section&id=13.%20Earnings%20per%20Common%20Share%20(%22EPS%22)) Basic and diluted EPS was **$0.01** for Q3 2023 and **$(0.05)** for the nine months, with antidilutive securities excluded - Basic and Diluted EPS (3 months ended Sep 30, 2023): **$0.01**[164](index=164&type=chunk) - Basic and Diluted EPS (9 months ended Sep 30, 2023): **$(0.05)**[164](index=164&type=chunk) - Antidilutive Securities (9 months ended Sep 30, 2023): Excluded **7.7 million** RSUs/Market RSUs, **12.1 million** options/PNQs, and **47.5 million** shares from convertible notes[164](index=164&type=chunk) [14. Stock-Based Compensation Expense](index=31&type=section&id=14.%20Stock-Based%20Compensation%20Expense) Stock-based compensation expense increased to **$13.8 million** for the nine months, and the 2018 Equity Incentive Plan authorized **25 million** more shares Stock-Based Compensation Expense (in thousands) | Period | 2023 (in thousands) | 2022 (in thousands) | | :----- | :------------------ | :------------------ | | 3 Months Ended Sep 30 | $4,601 | $3,622 | | 9 Months Ended Sep 30 | $13,836 | $10,850 | - 2018 Equity Incentive Plan: Authorized shares increased by **25 million** in May 2023[167](index=167&type=chunk) - Unrecognized Stock-Based Compensation: **$21.1 million** for RSUs (**2.56 years** weighted average period) and **$17.4 million** for Market RSUs (**1.83 years** weighted average period) as of Sep 30, 2023[170](index=170&type=chunk) [15. Commitments and Contingencies](index=32&type=section&id=15.%20Commitments%20and%20Contingencies) Milestone Rights liability is **$3.9 million** with **$55.0 million** remaining, financing liability is **$104.1 million**, and insulin purchase commitments total **€64.6 million** - Milestone Rights Liability: **$3.9 million** as of Sep 30, 2023 (vs. **$4.8 million** as of Dec 31, 2022), with **$55.0 million** remaining payable upon achievement of milestones[176](index=176&type=chunk)[175](index=175&type=chunk) - Financing Liability (Sale-Leaseback): **$104.1 million** as of Sep 30, 2023 (**$9.7 million** current, **$94.4 million** long-term)[180](index=180&type=chunk) Insulin Purchase Commitments (€ in millions) | Year | Amount (€) | | :--- | :--------- | | 2023 | 2.4 | | 2024 | 14.6 | | 2025 | 15.5 | | 2026 | 19.4 | | 2027 | 9.2 | | **Total** | **64.6** | - Operating Lease Liabilities: **$5.5 million** as of Sep 30, 2023 (**$1.2 million** current, **$4.3 million** long-term)[188](index=188&type=chunk) [16. Income Taxes](index=35&type=section&id=16.%20Income%20Taxes) A full valuation allowance is maintained against net deferred tax assets, with no liability for unrecognized tax benefits expected - Valuation Allowance: Full valuation allowance recorded against net deferred tax assets[191](index=191&type=chunk) - Unrecognized Tax Benefits: No liability recognized; no significant changes expected in the next 12 months[191](index=191&type=chunk) - Tax Years Subject to Examination: Since 2018[191](index=191&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=36&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses MannKind's financial condition, operating results, key trends, revenue drivers, expense changes, and liquidity needs [Overview](index=36&type=section&id=OVERVIEW) MannKind, a biopharmaceutical company, reported **$1.7 million** net income for Q3 2023, with an accumulated deficit of **$3.2 billion**, funded by various sources - Business Focus: Biopharmaceutical company developing and commercializing products for endocrine and orphan lung diseases (Afrezza, V-Go, Tyvaso DPI)[195](index=195&type=chunk) - Financial Performance (Q3 2023): Net income of **$1.7 million** for the three months ended Sep 30, 2023[197](index=197&type=chunk) - Accumulated Deficit: **$3.2 billion** as of Sep 30, 2023[197](index=197&type=chunk) - Funding Sources: Equity and convertible debt sales, upfront/milestone payments from collaborations, borrowings, product sales (Afrezza, V-Go), royalties/manufacturing revenue (UT), and sale-leaseback proceeds[197](index=197&type=chunk) [Critical Accounting Policies and Estimates](index=36&type=section&id=CRITICAL%20ACCOUNTING%20POLICIES%20AND%20ESTIMATES) Refers to the Annual Report on Form 10-K and Note 1 for detailed critical accounting policies and estimates - Reference: Critical accounting policies and estimates are detailed in Item 7 of the Annual Report on Form 10-K for December 31, 2022, and Note 1 of the current 10-Q[198](index=198&type=chunk) [Results of Operations](index=36&type=section&id=RESULTS%20OF%20OPERATIONS) Total revenues grew **56%** (QoQ) and **121%** (YoY), driven by collaboration royalties, with Afrezza revenue up and R&D expenses significantly increasing Total Revenues (in thousands) | Period | 2023 (in thousands) | 2022 (in thousands) | Change (YoY) | % Change (YoY) | | :----- | :------------------ | :------------------ | :----------- | :------------- | | 3 Months Ended Sep 30 | $51,253 | $32,825 | $18,428 | 56% | | 9 Months Ended Sep 30 | $140,490 | $63,711 | $76,779 | 121% | - Royalty Revenue – Collaborations: Increased by **$14.0 million (225%)** for the three months and **$44.4 million** for the nine months ended Sep 30, 2023, primarily due to increased patient demand for Tyvaso DPI[202](index=202&type=chunk)[203](index=203&type=chunk)[208](index=208&type=chunk)[209](index=209&type=chunk) - Afrezza Net Revenue: Increased by **24%** for the three months and **26%** for the nine months ended Sep 30, 2023, driven by higher product demand and price[203](index=203&type=chunk)[204](index=204&type=chunk) - V-Go Net Revenue: Decreased by **18%** for the three months but increased by **92%** for the nine months ended Sep 30, 2023 (due to acquisition in May 2022)[206](index=206&type=chunk)[207](index=207&type=chunk) - Commercial Product Gross Margin: **78%** for the three months and **73%** for the nine months ended Sep 30, 2023 (vs. **69%** for both periods in 2022)[211](index=211&type=chunk)[212](index=212&type=chunk) - Research and Development Expenses: Increased by **142% ($5.9 million)** for the three months and **75% ($9.5 million)** for the nine months ended Sep 30, 2023, due to MNKD-101 development, INHALE-3 study, headcount, and other pipeline products[215](index=215&type=chunk)[216](index=216&type=chunk)[217](index=217&type=chunk) [Liquidity and Capital Resources](index=41&type=section&id=LIQUIDITY%20AND%20CAPITAL%20RESOURCES) Liquidity is **$144.3 million**, with **$12.4 million** cash from operations, **$277.1 million** outstanding debt, and **€64.6 million** in insulin purchase commitments - Cash, Cash Equivalents, and Investments: **$83.0 million** in cash and cash equivalents, **$58.0 million** in short-term investments, and **$3.3 million** in long-term investments as of Sep 30, 2023[233](index=233&type=chunk) - Net Cash from Operating Activities (9 months ended Sep 30): **$12.4 million** provided in 2023 (vs. **$78.3 million** used in 2022)[230](index=230&type=chunk) - Outstanding Debt: **$277.1 million** principal amount as of Sep 30, 2023[227](index=227&type=chunk) - Insulin Purchase Commitments: **€64.6 million** as of Sep 30, 2023[227](index=227&type=chunk) - Liquidity Outlook: Believes resources are sufficient for the next twelve months[226](index=226&type=chunk)[234](index=234&type=chunk) [Contractual Obligations](index=42&type=section&id=Contractual%20Obligations) Refers to Note 9 (Borrowings) and Note 15 (Commitments and Contingencies) for details on contractual obligations - Reference: Material changes in contractual obligations are discussed in Note 9 – Borrowings and Note 15 – Commitments and Contingencies[235](index=235&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=43&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Discusses market risks, including interest rate risk from the MidCap credit facility and foreign currency risk from Euro-denominated obligations [Interest Rate Risk](index=43&type=section&id=Interest%20Rate%20Risk) Exposed to interest rate risk from the variable-rate MidCap credit facility, but a **10%** SOFR change would not materially affect obligations - MidCap Credit Facility: Variable interest rate (one-month SOFR + **6.25%**, capped at **8.25%**, **1%** SOFR floor)[237](index=237&type=chunk) - Other Debt: Fixed interest rates (Senior convertible notes **2.50%**, Mann Group convertible note **2.50%**)[237](index=237&type=chunk) - Sensitivity: A hypothetical **10%** change in one-month SOFR would not have a material effect on interest payment obligations[238](index=238&type=chunk) [Foreign Currency Exchange Risk](index=43&type=section&id=Foreign%20Currency%20Exchange%20Risk) Faces foreign currency exchange risk from Euro-denominated obligations, uses hedging, and a **10%** USD to Euro change could impact pre-tax loss by **$6.5 million** - Exposure: Euro-denominated insulin supply obligations[240](index=240&type=chunk) - Hedging: Uses 90-day foreign currency hedging transactions[239](index=239&type=chunk) - Currency Gain (9 months ended Sep 30, 2023): **$0.9 million**[240](index=240&type=chunk) - Sensitivity: A hypothetical **10%** change in USD to Euro exchange rate could result in a **$6.5 million** impact on pre-tax loss[241](index=241&type=chunk) [Item 4. Controls and Procedures](index=43&type=section&id=Item%204.%20Controls%20and%20Procedures) Evaluates disclosure controls and procedures, confirming effectiveness as of Sep 30, 2023, with no material changes in internal control [Disclosure Controls and Procedures](index=43&type=section&id=Disclosure%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2023 - Effectiveness: Disclosure controls and procedures were effective as of September 30, 2023[243](index=243&type=chunk) [Changes in Internal Control over Financial Reporting](index=44&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) No material changes in internal control over financial reporting were identified during the latest fiscal quarter - No Material Changes: No material changes in internal control over financial reporting during the latest fiscal quarter[245](index=245&type=chunk) [PART II: OTHER INFORMATION](index=45&type=section&id=PART%20II%3A%20OTHER%20INFORMATION) This section provides additional information including legal proceedings, risk factors, equity sales, and executive trading plans [Item 1. Legal Proceedings](index=45&type=section&id=Item%201.%20Legal%20Proceedings) MannKind is involved in ordinary course legal proceedings, not expected to materially affect financial position or results - Impact: Final disposition of legal proceedings not expected to have a material adverse effect on financial position, results of operations, or cash flows[247](index=247&type=chunk) [Item 1A. Risk Factors](index=45&type=section&id=Item%201A.%20Risk%20Factors) Outlines significant risks to common stock investment, categorized into business, government regulation, common stock, and general market conditions - Summary of Key Risks: Investment in common stock is speculative due to risks related to commercial success, manufacturing, capital needs, regulatory environment, stock price volatility, and general market conditions[248](index=248&type=chunk)[249](index=249&type=chunk)[250](index=250&type=chunk)[253](index=253&type=chunk)[254](index=254&type=chunk)[255](index=255&type=chunk) [Summary Risk Factors](index=45&type=section&id=Summary%20Risk%20Factors) Summarizes principal factors making common stock investment speculative, categorized into business, government regulation, common stock, and general risks - Categorized list of key risks (commercial success, manufacturing, capital needs, regulatory, stock price volatility)[250](index=250&type=chunk)[253](index=253&type=chunk)[254](index=254&type=chunk) [Risks Related to Our Business](index=46&type=section&id=RISKS%20RELATED%20TO%20OUR%20BUSINESS) Details business risks including commercialization, manufacturing, supply chain, capital needs, operating losses, indebtedness, and IT systems - Commercial success of products (Afrezza, V-Go, Tyvaso DPI) is uncertain[256](index=256&type=chunk) - Manufacturing risks at Danbury facility and reliance on contract manufacturers in China for V-Go[260](index=260&type=chunk)[265](index=265&type=chunk) - Dependence on single-source suppliers for critical components[267](index=267&type=chunk) - Need for additional capital to fund operations[274](index=274&type=chunk) - History of operating losses and potential for future losses[280](index=280&type=chunk) - Ability to service indebtedness and commitments depends on financial performance[282](index=282&type=chunk) - Business susceptible to health pandemics/epidemics and geopolitical events[286](index=286&type=chunk)[320](index=320&type=chunk) - Delays in product development goals (e.g., MNKD-101 Phase 2/3 study)[295](index=295&type=chunk) - Risks related to V-Go acquisition and integration[298](index=298&type=chunk) - Vulnerability to cyber-attacks and data breaches[324](index=324&type=chunk)[325](index=325&type=chunk) - Adverse developments in financial services industry[334](index=334&type=chunk) [Risks Related to Government Regulation](index=61&type=section&id=RISKS%20RELATED%20TO%20GOVERNMENT%20REGULATION) Covers risks from regulatory approval, ongoing compliance with healthcare laws, data privacy, and impacts of healthcare legislation - Costly and time-consuming regulatory approval process[340](index=340&type=chunk) - Ongoing stringent government regulation and compliance requirements[347](index=347&type=chunk) - Impact of healthcare legislation (PPACA, IRA) on product pricing and reimbursement[353](index=353&type=chunk)[355](index=355&type=chunk) - Compliance with federal and state healthcare fraud and abuse laws[357](index=357&type=chunk) - Stringent and changing data privacy and security obligations (HIPAA, CCPA, GDPR)[360](index=360&type=chunk)[363](index=363&type=chunk) - Risks from generative AI technologies[364](index=364&type=chunk) [Risks Related to Our Common Stock](index=68&type=section&id=RISKS%20RELATED%20TO%20OUR%20COMMON%20STOCK) Addresses stock price volatility, potential dilution from future equity sales, delisting risks, anti-takeover provisions, and reliance on appreciation - Stock price volatility due to various factors[395](index=395&type=chunk) - Potential for dilution from future equity/debt sales[406](index=406&type=chunk) - Risk of delisting from Nasdaq Global Market[398](index=398&type=chunk) - Anti-takeover provisions and exclusive forum provisions[401](index=401&type=chunk)[402](index=402&type=chunk) - No expected dividends; reliance on stock appreciation[405](index=405&type=chunk) [General Risk Factors](index=73&type=section&id=GENERAL%20RISK%20FACTORS) Discusses broader risks from unstable market, economic, and geopolitical conditions and their potential adverse impact - Impact of unstable market, economic, and geopolitical conditions[410](index=410&type=chunk)[411](index=411&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=74&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) MannKind issued **13,439** common shares in July 2023 to The Mann Group LLC for convertible note interest, relying on registration exemptions - Common Stock Issuance: **13,439 shares** issued in July 2023 to pay interest on Mann Group convertible note[412](index=412&type=chunk) - Exemption: Relied on Section 3(a)(9) or 4(a)(2) of the Securities Act of 1933[412](index=412&type=chunk) [Item 3. Defaults Upon Senior Securities](index=74&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - No Defaults: No defaults upon senior securities[413](index=413&type=chunk) [Item 4. Mine Safety Disclosures](index=74&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to MannKind Corporation - Not Applicable: Mine safety disclosures are not applicable[413](index=413&type=chunk) [Item 5. Other Information](index=74&type=section&id=Item%205.%20Other%20Information) Three executive officers adopted Rule 10b5-1 trading plans in Q3 2023 for orderly disposition of company securities - Executive Trading Plans: Three executive officers adopted Rule 10b5-1 trading plans in Q3 2023[414](index=414&type=chunk)[415](index=415&type=chunk) - Shares to be Sold: Michael Castagna (**190,482 shares**), Steven Binder (approx. **31,000 shares**), David Thomson (approx. **37,000 shares**)[415](index=415&type=chunk) [Item 6. Exhibits](index=75&type=section&id=Item%206.%20Exhibits) Lists all exhibits filed with the Form 10-Q, including corporate documents, debt agreements, and certifications - Exhibit List: Includes Amended and Restated Certificate of Incorporation, Bylaws, Milestone Rights Purchase Agreement, Convertible Promissory Notes, Indenture for Senior Convertible Notes, and CEO/CFO certifications[417](index=417&type=chunk)[422](index=422&type=chunk)[424](index=424&type=chunk)[426](index=426&type=chunk)[429](index=429&type=chunk)[431](index=431&type=chunk)[433](index=433&type=chunk) [SIGNATURES](index=77&type=section&id=SIGNATURES) This section contains the official signatures of the Chief Executive Officer and Chief Financial Officer, certifying the report [Signature](index=77&type=section&id=SIGNATURE) The report is duly signed by the Chief Executive Officer and Chief Financial Officer on November 7, 2023 - Signatories: Michael E. Castagna (CEO) and Steven B. Binder (CFO)[434](index=434&type=chunk) - Date: November 7, 2023[434](index=434&type=chunk)