DANBURY, Conn. and BURLINGTON, Mass., Oct. 07, 2025 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) successfully completed the previously announced acquisition of scPharmaceuticals Inc. The acquisition of scPharmaceuticals is expected to diversify and accelerate MannKind’s double-digit revenue growth, driven by FUROSCIX® (furosemide injection), an innovative therapy for edema due to chronic heart failure and chronic kidney disease. The transaction will strengthen MannKind’s commercial and medical ca ...

MannKind FY Conference Summary Company Overview - MannKind Corporation (NasdaqGM:MNKD) has been in operation for 34 years, primarily known for inhalation therapeutics and diabetes treatments [4][5] - The company is diversifying away from diabetes, focusing on applying inhalation technology in various therapeutic areas [4] Recent Developments - MannKind has entered late-stage development programs, including cofazamine in Phase 3 and nintedanib in Phase 2 [4] - The company has partnered with United Therapeutics, which has positively impacted the performance of Tyvaso DPI [4][5] - A significant acquisition of SC Pharmaceuticals was announced, marking a transformative decision for the company [5][14] Key Growth Drivers - Upcoming label change for Afrezza in October 2025, aimed at resolving dosing issues [9] - Anticipated acceptance of the pediatric file for Afrezza within the next few weeks [9] - Enrollment of the 100th evaluable patient for cofazamine expected in the next 60 to 90 days [9] - SC Pharmaceuticals acquisition expected to close in Q4 2025 [9][10] - Multiple catalysts anticipated over the next 18 months, including pediatric approval and autoinjector developments [11] SC Pharmaceuticals Acquisition - The acquisition was driven by the need for a complementary asset and the potential for faster growth [14] - The overlap between diabetes and heart failure markets was highlighted, with a significant percentage of heart failure patients also having diabetes [15] - The integration plan focuses on maximizing the sales force's effectiveness across both companies [15][20] Tyvaso DPI and IPF Developments - Positive results from the TEPTEN-2 study are expected to enhance the royalty stream from United Therapeutics [21] - United Therapeutics is heavily investing in idiopathic pulmonary fibrosis (IPF), with a billion-dollar commitment to manufacturing and development [22] - MannKind is confident in the FDA's expedited review process for Tyvaso DPI and its potential impact on patients [22][23] Nintedanib Phase 2 Trial - The trial is expected to start soon, with top-line data anticipated in the first half of 2027 [30] - The study will involve 228 patients, testing different dosing regimens [30][34] - Confidence in the inhaled approach is based on previous studies showing no significant gastrointestinal side effects [41] Afrezza Relaunch Strategy - The label change for Afrezza is seen as a critical step for its relaunch, particularly in pediatric populations [62][64] - A new marketing campaign and sales materials are set to be implemented in Q4 2025 [62] - The company aims to target a broader market, including pediatric patients and those with gestational diabetes [72][75] Financial Outlook - MannKind is positioned for a challenging financial year ahead but has sufficient capital to support its initiatives [78] - The company anticipates significant revenue growth from multiple product launches and clinical trial results in 2026 [78] - The management emphasizes the importance of successful integration of SC Pharmaceuticals to build confidence for future M&A opportunities [81] Conclusion - MannKind is at a pivotal moment with multiple upcoming catalysts and a strong focus on expanding its product offerings and market presence [84] - The company believes it remains undervalued compared to peers, with a solid revenue growth outlook and cash reserves to fund innovation [84]

Core Insights - The company has transitioned from being primarily a diabetes-focused entity to diversifying its portfolio, particularly in the area of rare diseases and orphan lung conditions [1] - The partnership with UT has been fruitful and continues to develop positively, indicating a strong collaborative effort in research and development [1] - The company aims to create more catalysts for growth and positive developments to attract momentum and catalyst-driven investors [1]

Core Insights - The company is focused on the acquisition and integration process, emphasizing its importance for future success [1] - A label change for Afrezza is anticipated, which is considered a significant upcoming event [1] - The company is preparing to scale up manufacturing and ensure emergency supplies as new data from the TETON study becomes available [1] - There is ongoing collaboration related to a new formulation opportunity, indicating continued innovation efforts [1]

Summary of MannKind's Conference Call Company Overview - **Company**: MannKind Corporation - **Industry**: Biotechnology, specifically focusing on inhaled insulin and treatments for pulmonary diseases Key Points and Arguments Strategic Priorities - **Acquisition Integration**: The primary focus is on the integration of a recent acquisition, emphasizing that successful integration is crucial for future growth [3][4] - **Label Change for Afrezza**: A significant label change for Afrezza is anticipated, which is considered important for the company's future [3][4] - **Teton Data**: The company is preparing for the influx of data from the Teton studies, which will influence manufacturing and supply strategies [4][5] Financial Insights - **Royalty Deal**: A royalty deal valued at $1.5 billion for a 10% royalty on Tyvaso was initiated, with a milestone payment of $50 million contingent on achieving certain sales targets [10][11] - **Valuation Concerns**: Despite the positive developments, the company's current trading value is below the estimated $2 billion valuation based on the royalty sale [11][12] Market Opportunities - **IPF Market**: The idiopathic pulmonary fibrosis (IPF) market is highlighted as having significant potential, with current treatments showing high dropout rates. The company believes that their product could become a backbone treatment [16][18] - **Patient Needs**: There is a strong emphasis on the unmet needs of IPF patients, with current options being inadequate [14][16] Product Development - **Internal Candidate (MNKD 201)**: The company is developing an inhaled version of Nintentinib, believing it will complement existing treatments rather than compete directly [27][30] - **Phase Two Trials**: Plans for a Phase Two trial are underway, focusing on different dosing regimens and the potential for combination therapies [30][36] Commercial Strategy - **Acquisition of SC Pharma**: The acquisition aims to diversify revenue streams and reduce reliance on Tyvaso, which currently accounts for 65% of revenue [45][48] - **Sales Force Expansion**: The company plans to increase the number of sales representatives to enhance market presence and support for new products [55][56] Regulatory and Market Access - **Label Expansion for Afrezza**: A label change is expected in October, which will allow for new dosing information and potentially improve market access [63][64] - **Pediatric Opportunity**: The company is preparing for a pediatric launch, with dedicated resources to ensure focus on this segment [65][66] Challenges and Considerations - **Part D Redesign**: The redesign of Medicare Part D poses challenges for patient access, but the company is optimistic about improving access as the year progresses [59][71] - **Physician Acceptance**: There is a noted shift in physician attitudes towards inhaled insulin, particularly regarding lung safety, which has historically been a barrier to prescription [68][70] Additional Important Insights - **Patient-Centric Approach**: The company emphasizes the importance of patient access and the need for effective treatments for those with limited options [14][25] - **Market Dynamics**: The competitive landscape is evolving, and the company is focused on ensuring that their products can meet the needs of patients effectively [40][42] This summary encapsulates the key discussions and insights from MannKind's conference call, highlighting the company's strategic direction, market opportunities, and challenges ahead.

Financial Data and Key Metrics Changes - The company is profitable and growing, with a focus on diversifying its revenue streams and increasing operational leverage [6][10][88] - The goal is to achieve a roughly 50-50 ratio between royalties/manufacturing and in-line commercialization products [10] Business Line Data and Key Metrics Changes - The acquisition of SC Pharmaceuticals is aimed at diversifying the business, with a focus on drug-device combinations and leveraging existing expertise in injectable platforms [4][6] - The company is targeting a $5 billion market for insulin pumps, indicating significant revenue potential from this segment [8] Market Data and Key Metrics Changes - There are approximately 100,000 patients in the U.S. and over 100,000 in Japan for the targeted market, indicating a large unmet need despite existing competition [38] - The company anticipates that the pediatric segment could significantly influence overall insulin prescriptions, as it represents a critical entry point for new treatments [69][72] Company Strategy and Development Direction - The company is focusing on the cardiometabolic space, with a strategy to integrate new acquisitions and enhance its product pipeline [9][60] - There is a strong emphasis on clinical development in rare diseases, particularly in orphan lung diseases, to differentiate from competitors [2][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to navigate the competitive landscape and highlighted the importance of timely clinical trial enrollments to avoid delays [24][25] - The management team is optimistic about the upcoming pediatric launch of Afrezza, viewing it as a potential inflection point for revenue growth [65][68] Other Important Information - The company has invested significantly in scaling up manufacturing capabilities to meet future demand, with plans for a new facility in North Carolina [60] - The management is focused on ensuring that the integration of SC Pharmaceuticals is successful while also preparing for the pediatric launch of Afrezza [65][86] Q&A Session Summary Question: How does the acquisition of SC Pharmaceuticals fit into the company's strategy? - The acquisition is seen as a way to diversify the business and leverage existing expertise in drug-device combinations, with a focus on scaling revenue [4][6] Question: What is the expected market opportunity for the new products? - The company estimates a large market potential, particularly in the cardiometabolic space, with significant overlap in patient populations [9][38] Question: How does the company plan to address competition in the market? - Management believes there is enough unmet need to support multiple products in the market, and they are focusing on differentiating their offerings [37][40] Question: What are the key priorities for the company moving forward? - Key priorities include the integration of SC Pharmaceuticals, the pediatric launch of Afrezza, and advancing clinical development programs [65][86] Question: How does the company view the potential for Afrezza in the pediatric market? - The management sees a significant opportunity in the pediatric segment, with plans to hire a dedicated team to support the launch [68][69]

Core Insights - MannKind Corporation has agreed to acquire scPharmaceuticals Inc. for a deal value of up to approximately $360 million, or $5.35 per share, marking a strategic expansion into cardiorenal medicine [1] - The acquisition is supported by MannKind's recent $500 million strategic financing agreement with Blackstone [1] Company Overview - ScPharmaceuticals markets Furoscix, an FDA-approved on-body infuser for treating fluid overload in adult patients with chronic heart failure and chronic kidney disease, with a total addressable market opportunity exceeding $10 billion in the U.S. [2] - For the six months ended June 30, scPharmaceuticals reported net sales of $27.8 million, reflecting a 96% year-over-year increase [2] Product Development - The Furoscix ReadyFlow Autoinjector is expected to submit a supplemental New Drug Application in Q3 2025, aiming to reduce treatment time from five hours to less than 10 seconds [3] Strategic Goals - MannKind's CEO highlighted that the acquisition expands patient-centered brands and demonstrates the company's commitment to innovative therapies for cardiometabolic and orphan lung diseases, with expectations for double-digit growth over the next decade [4] - The combined company will own Afrezza, Furoscix, and V-Go, with an annualized run rate of over $370 million based on second-quarter 2025 earnings [4] Market Reaction - Following the acquisition announcement, scPharmaceuticals' stock rose by 15.36% to $5.59, while MannKind's stock decreased by 4.50% to $3.93 [5] Pipeline Advancements - MannKind is advancing a late-stage pipeline that includes inhaled Clofazimine (MNKD-101) for nontuberculous mycobacterial lung disease and Nintedanib DPI (MNKD-201), which is expected to initiate a phase 2 clinical trial for idiopathic pulmonary fibrosis by the end of 2025 [6]

Core Viewpoint - MannKind Corporation has signed a definitive merger agreement to acquire scPharmaceuticals Inc, marking a strategic expansion into cardiorenal medicine and enhancing its cardiometabolic business alongside its orphan lung division [1][2]. Strategic and Financial Benefits - The acquisition is expected to diversify and accelerate double-digit revenue growth, particularly through FUROSCIX, which addresses significant unmet needs in chronic heart failure and chronic kidney disease [6][7]. - MannKind will pay an upfront cash of $5.35 per share, representing a 36% premium to scPharmaceuticals' 90 trading day VWAP, with total consideration potentially reaching $6.35 per share [6][9]. - The total equity value of the transaction is approximately $303 million, with a total deal value of up to $360 million, expected to close in Q4 2025 [9]. Commercial Momentum - scPharmaceuticals has shown strong commercial momentum, with net sales of $27.8 million for the first half of 2025, reflecting a 96% year-over-year increase [3]. - The FUROSCIX ReadyFlow Autoinjector is on track for a supplemental New Drug Application submission in Q3 2025, which could significantly reduce treatment time for patients [3][6]. Revenue Diversification - The combined company will have a stronger revenue base with three commercial assets: Afrezza, FUROSCIX, and V-Go, leading to an annualized run rate of over $370 million based on Q2 2025 results [7]. - MannKind anticipates double-digit annual growth from its commercial products, supported by upcoming product launches and indication expansions [7][8]. Integration and Growth Opportunities - The integration of scPharmaceuticals' established commercial and medical capabilities into MannKind's infrastructure is expected to unlock meaningful growth opportunities [6][8]. - MannKind's existing strengths in endocrinology and scPharmaceuticals' expertise in cardiovascular care will enhance the market opportunity for FUROSCIX in chronic kidney disease [8].

Financial Data and Key Metrics Changes - The company reported Q2 revenues of $77 million, a 6% increase over 2024, and year-to-date revenues of $155 million, reflecting a 12% increase over 2024 [6][18] - The balance sheet remains strong with $201 million in cash and access to $500 million in non-dilutive capital from Blackstone [7][22] - Total revenues over the trailing four quarters exceeded $300 million, with expectations for continued growth [18] Business Line Data and Key Metrics Changes - The endocrine business unit generated $18.3 million in revenue, representing a 13% growth over 2024 [6] - Afrezza net revenues for Q2 were $18 million, a 13% increase year-over-year, while V Go net revenue was approximately $4 million, an 8% decrease [19][20] - Tyvaso DPI royalties contributed $31 million in Q2, marking a 22% increase from the same quarter last year [18] Market Data and Key Metrics Changes - The company targets about 25% of all rapid-acting scripts, with 1% of the rapid-acting market estimated at a $300 million run rate for Afrezza [4] - The NTM market is expected to exceed $1 billion by the end of the decade, with a focus on the US and Japan [7] Company Strategy and Development Direction - The company is focused on creating shareholder value, minimizing dilution, and enhancing flexibility for future growth [3] - Upcoming trials include the launch of the inflow trial for NTM by the end of 2025 and the pediatric indications for Afrezza [6][14] - The company aims to enhance its commercial infrastructure and expand its sales force in preparation for the pediatric launch of Afrezza [16][73] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming TETON-two results and their potential impact on business plans [3][14] - The company anticipates continued growth in royalty revenue driven by Tyvaso DPI sales and expects Afrezza to maintain its growth trajectory [20][21] - Management highlighted the importance of the Blackstone deal in providing the necessary capital for growth and innovation [25][22] Other Important Information - The company has entered into a strategic financing arrangement with Blackstone, providing access to up to $500 million in non-dilutive funding [22] - The company is preparing for a new marketing campaign called "insulin in the moment" to enhance awareness and adoption of Afrezza [15] Q&A Session Summary Question: Can you walk us through the timeline for a potential bridging study in IPF? - Management indicated that the timeline could be faster than previous studies, depending on the results of TETON-two and TETON-one [30][31] Question: How is the intended DPI program positioned in the current treatment landscape? - Management noted that the program is designed to be used in combination with existing therapies and is focused on patients intolerant to current treatments [34][40] Question: What is the typical Afrezza patient profile today? - The breakdown of patients is approximately 45% Type 1 and 55% Type 2, with a growing focus on Type 1 patients [66][67] Question: What are the conditions for drawing additional capital from the Blackstone agreement? - The company can draw funds at its discretion without specific sales or development milestones [98]

Core Viewpoint - MannKind Corporation has entered into a strategic financing agreement with Blackstone, providing up to $500 million in non-dilutive capital to support its growth strategies and commercial initiatives [1][2]. Group 1: Financing Details - MannKind will receive an initial $75 million in cash at closing, with a total financing facility of up to $500 million [1]. - The financing includes a $125 million delayed draw term loan (DDTL) available over the next 24 months, and an additional $300 million uncommitted DDTL subject to mutual consent [2]. - The facility bears interest at a SOFR variable rate plus 4.75%, with potential increases based on leverage ratios, and matures in August 2030 without scheduled amortization payments [2]. Group 2: Strategic Implications - The funding will enhance MannKind's operational flexibility and support the expansion of its commercial team in anticipation of the pediatric indication for Afrezza, pending approval [2]. - The capital will also facilitate continued pipeline advancement and potential business development opportunities [2]. - Blackstone's involvement is expected to provide MannKind with access to a value creation platform and life sciences expertise, aiding in commercialization efforts [2]. Group 3: Company Overview - MannKind Corporation focuses on developing and commercializing inhaled therapeutic products for endocrine and orphan lung diseases [3]. - The company aims to address serious unmet medical needs through innovative dry-powder formulations and inhalation devices [4].