DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Jan. 08, 2026 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions for cardiometabolic and orphan lung diseases, today provided business updates and outlined anticipated growth drivers for 2026, including progress across its commercial programs and clinical development initiatives. “MannKind closed 2025 on a high note, marked by milestones ...

Core Viewpoint - Truist Securities has initiated coverage on MannKind (NASDAQ: MNKD) with a Buy rating and a price target of $9 [1] Group 1: Commercial and Development Programs - MannKind's execution in both commercial and development programs is viewed positively by Truist [2] - The valuation outlook is primarily driven by Tyvaso DPI royalty revenue, with projected growth in idiopathic pulmonary fibrosis (IPF) and pulmonary hypertension associated with interstitial lung disease (PPF) [2] - Truist estimates peak revenue of approximately $300 million for the Tyvaso franchise by 2030 [2] Group 2: Additional Growth Opportunities - Additional upside is anticipated from Afrezza in diabetes, with potential expansion into pediatric use next year [3] - Furoscix, acquired through the purchase of scPharma, is also expected to contribute to growth [3] - MannKind's orphan-lung pipeline offers further diversification and long-term growth opportunities [3]

Summary of MannKind Conference Call Company Overview - **Company**: MannKind Corporation (NasdaqGM: MNKD) - **Date**: November 19, 2025 - **Focus**: Development and commercialization of innovative therapies for diabetes and other serious conditions Key Points Industry and Market Opportunities - **Furoscix**: An on-body infuser for furosemide targeting heart failure patients, representing a market opportunity exceeding $10 billion in the U.S. and G7 countries [1][2] - **Fluid Edema Episodes**: Approximately 2.1 million episodes in the U.S., with 80% of costs attributed to hospitalizations due to inability to administer IV Lasix at home [2] - **Readmission Penalties**: New penalties for physicians based on managing heart failure patients effectively, potentially impacting their compensation by 15%-20% [2] Financial Performance - **Furoscix Revenue**: Generated $19.3 million in Q3, with a year-over-year growth of 93% [3] - **Doses Dispensed**: Over 61,000 doses dispensed, with 27,000 in Q3 alone [3] Product Development and Sales Strategy - **Sales Force Expansion**: Increased from a small team to 80 representatives, enhancing market penetration [3][4] - **Nephrology Indication**: 15% of Q3 sales attributed to nephrology, expected to grow further [4] - **Market Engagement**: Targeting 5,000 to 7,000 cardiologists and nephrologists to increase product awareness and adoption [5] Technological Innovations - **FDKP Technology**: Aimed at providing an IV-like experience for bumetanide, enhancing bioavailability and patient compliance [7][8] - **Auto Injector Development**: Designed to simplify administration for patients, reducing the hassle associated with on-body infusers [6] Competitive Landscape - **Tyvaso DPI**: Marketed by United Therapeutics, reported $59 million in Q3 revenue, up 15% year-over-year [9] - **Collaboration with United Therapeutics**: Ongoing partnerships to enhance product offerings and market reach [10][25] Future Trials and Research - **Phase One Trials**: Initiating trials for new formulations, including a nebulized version of clofazimine and a dry powder inhalation for IPF [11][12] - **Pediatric Market Focus**: Exploring opportunities in the pediatric diabetes market, with potential for significant revenue growth [16][17] Revenue Projections - **Pro Forma Revenues**: Expected to exceed $100 million in Q3, driven by product growth and collaborations [24] - **Market Potential**: Every 100,000 patients represents approximately $350 million in revenue, indicating a large unmet need in the market [25] Strategic Vision - **Long-term Growth**: Emphasis on building a diversified pipeline and inline revenue, with a focus on innovative therapies for diabetes and cardiometabolic conditions [26] Additional Insights - **Gestational Diabetes Opportunity**: Physicians have expressed interest in Afrezza for gestational diabetes, highlighting its safety and efficacy [22][23] - **AI Integration**: Future plans to incorporate AI for real-time insulin control and patient management [21] This summary encapsulates the key insights and strategic directions discussed during the MannKind conference call, highlighting the company's focus on innovative therapies and market expansion opportunities.

Liquidia Corp (NasdaqCM:LQDA) Conference Call Summary Company Overview - **Company**: Liquidia Corp - **Product**: YUTREPIA, a PRINT-enabled product for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) [3][5] Key Points Product Launch and Financial Performance - YUTREPIA achieved **$51.7 million** in revenue during its first full quarter post-launch [3] - Over **2,000 prescriptions** and **1,500 new patient starts** reported by the end of October [7] - October was noted as the highest referral month since the launch, indicating strong momentum [7] Product Profile and Market Position - YUTREPIA's product profile includes benefits in **efficacy, safety, and convenience** [4] - The formulation leads to **reduced cough**, allowing for higher dose tolerability and quicker dose escalation [4][5] - The company aims to capture a significant share of the PAH and PH-ILD market, targeting **6,000 prescribers** with **650 currently prescribing** YUTREPIA [11] Patient Dynamics and Market Access - **75%** of current patients are new users of prostacyclin, with **25%** switching from existing therapies [10] - The company is focusing on transitioning patients from Tyvaso and Tyvaso DPI, particularly those unable to tolerate higher doses [12][13] - The **voucher program** has been utilized by over **50%** of patients, facilitating access to YUTREPIA [9] Clinical Data and Efficacy - Clinical studies show significant improvements in walk distance for patients on YUTREPIA, with a **20% discontinuation rate** compared to a **70% rate** for Tyvaso [17] - The company is preparing additional studies to demonstrate the benefits of transitioning patients from other therapies to YUTREPIA [12][16] Legal Considerations - The company is awaiting a court decision regarding ongoing litigation, with management expressing confidence in their position [26][28] - Various potential outcomes are being considered, including a reasonable royalty rate or a modified label for YUTREPIA [27][30] Future Development and Pipeline - Liquidia is exploring the use of YUTREPIA in other indications such as idiopathic pulmonary fibrosis (IPF) and pulmonary hypertension associated with chronic obstructive pulmonary disease (PHCOPD) [38][40] - The company is also developing L606, a sustained-release formulation, which is expected to have a favorable safety profile and dosing regimen [42][46] Financial Outlook - The company became operationally profitable two quarters ahead of expectations, with gross margins for YUTREPIA at **96%** in Q3 [50] - Management plans to reinvest profits into the pipeline while maintaining a disciplined approach to growth [52] Additional Insights - Physician feedback has been positive, with many practices considering wholesale transitions to YUTREPIA based on clinical data [19] - The company emphasizes the importance of patient access and the need for effective treatments in the market [30][32]

Summary of United Therapeutics Conference Call Company Overview - **Company**: United Therapeutics (NasdaqGS: UTHR) - **Event**: Jefferies Linden Healthcare Conference 2025 - **Date**: November 18, 2025 Key Points Current Commercial Business - **Revenue Growth**: United Therapeutics reported significant growth in total revenue, particularly from Tyvaso and Tyvaso DPI, which are expected to be the main growth drivers moving forward [4][6] - **Tyvaso DPI**: The product has no dosing limitations, is well-received by prescribers and patients, and has a favorable product profile, including ease of use [5][6] - **Market Position**: The company believes it is well-positioned in the pulmonary space, with a strong understanding of the market dynamics [4][6] Competitive Landscape - **Utrepia Launch**: Despite the launch of Utrepia, a competing product, United Therapeutics has seen a return in referrals and start trends towards Tyvaso, indicating strong market positioning [11][12] - **Market Expansion**: The presence of more therapies in the market is expected to expand the overall patient population rather than create a zero-sum game [13][14] Litigation Concerns - **Ongoing Litigation**: The company is awaiting a ruling on litigation related to Utrepia but remains confident in its growth trajectory regardless of the outcome [15][17][18] Future Projections - **Revenue Target**: United Therapeutics aims for a quarterly revenue run rate of $1 billion by the end of 2027, primarily driven by existing commercial products [19][21] - **IPF Opportunity**: The company sees a significant market opportunity in idiopathic pulmonary fibrosis (IPF), with an estimated 100,000 patients in the U.S. and a multi-billion dollar market potential [25][34] Clinical Trials and Pipeline - **Teton Trials**: The Teton 2 trial for IPF showed promising results, and there is high conviction that these results will translate to the Teton 1 trial in the U.S. [28][31] - **Regulatory Strategy**: The company plans to meet with the FDA to discuss the approval process for Tyvaso in IPF, aiming to expedite market entry [32][33] Additional Opportunities - **PPF and Rilendipag**: The company is optimistic about the potential for Tyvaso in pulmonary fibrosis (PPF) and is conducting trials for Rilendipag, an oral therapy expected to read out in 2026 [36][38] - **Xenotransplantation**: United Therapeutics is exploring organ transplantation, having conducted its first kidney transplant in a clinical trial, with plans to expand into lung and heart transplants [43][44] Financial Position and Strategy - **Overall Strategy**: The company is confident in its commercial pipeline and long-term organ manufacturing strategy, indicating a strong financial position [46][47] Conclusion United Therapeutics is positioned for significant growth driven by its existing products, promising clinical trials, and strategic market expansion. The company remains optimistic about its future revenue targets and the potential impact of its innovative therapies in the pulmonary and transplant markets.

Financial Data and Key Metrics Changes - The company reported record revenue of $82 million for Q3 2025, representing a 17% increase year-over-year [14] - Total revenues for the year-to-date period reached $237 million, indicating a 14% growth compared to the same period last year [17] - GAAP net income for Q3 was $8 million, down from $11.6 million in the prior year, while non-GAAP net income increased to $22.4 million from $15.4 million [18] Business Line Data and Key Metrics Changes - Tyvaso DPI generated $33 million in royalties, a 23% increase, and $26 million in manufacturing-related revenue [4] - Afrezza's net revenue rose 23% to $18.5 million, with a 31% increase in new prescriptions and a 27% increase in total prescriptions year-over-year [5][14] - V-Go contributed $3.8 million, down 19% year-over-year, consistent with the company's expectations as it no longer actively promotes the product [15] Market Data and Key Metrics Changes - Furoscix revenue reached $19.3 million in Q3 2025, with year-to-date revenue of $47.1 million, a 95% increase over the same period in 2024 [9] - The company anticipates significant market opportunities in heart failure and chronic kidney disease, with 2.1 million addressable heart failure episodes in the U.S. [10] Company Strategy and Development Direction - The acquisition of SC Pharmaceuticals is aimed at unlocking the potential of Furoscix and advancing inhaled bumetanide for fluid overload and heart failure [2][7] - The company is focused on expanding its footprint in cardiometabolic care and enhancing its commercial scale through the integration of SC Pharmaceuticals [6][7] - The strategy includes increasing the share of voice in cardiology and nephrology to raise awareness and drive adoption of Furoscix [12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the momentum in clinical development programs and the potential for growth through various catalysts [3] - The company is preparing for the pediatric launch of Afrezza, with a focus on driving prescribing among top prescribers [6] - Management highlighted the importance of early intervention in heart failure care, aligning with upcoming changes in Medicare payment models [11] Other Important Information - The company has submitted a supplemental BLA for Afrezza, with a PDUFA date set for Q2 2026 [2] - The company utilized $133 million of its cash and investments to fund the acquisition of SC Pharmaceuticals and borrowed $325 million on a term loan facility [16] Q&A Session Summary Question: Thoughts on recent approvals from Furoscix competitors and pricing context - Management acknowledged awareness of competitors and emphasized product differentiation and lifecycle management as key focuses [28] Question: Timing for the Tyvaso bridging study in IPF - Management indicated that the bridging study could be similar to the BREEZE study, with communication to the FDA expected soon [34] Question: Integration process with SC Pharmaceuticals - Integration is progressing smoothly, with cultural similarities easing the process and key personnel already placed in leadership roles [36] Question: Peak sales opportunity for Furoscix - Management referenced analyst reports suggesting peak sales could exceed $500 million, with further guidance pending [45] Question: Impact of the Ready Flow Auto-Injector on unique prescribers - Management highlighted the potential for market expansion and increased awareness among cardiologists as key growth drivers [79]

Core Insights - MannKind Corporation reported a 17% increase in Q3 2025 revenues to $82.1 million compared to Q3 2024, driven by higher royalties and product sales [6][9][14] - The acquisition of scPharmaceuticals is expected to enhance MannKind's commercial capabilities and accelerate revenue growth [2][7] - The FDA has accepted the sBLA for Afrezza in the pediatric population, with a PDUFA date set for May 29, 2026 [6][7] Financial Performance - Q3 2025 revenues reached $82.1 million, a $12.1 million increase from Q3 2024, with royalties up 23% to $33.3 million and Afrezza sales up 23% to $18.5 million [9][12] - Year-to-date revenues for 2025 totaled $237.0 million, reflecting a 14% increase compared to the same period in 2024 [14] - The company reported a net income of $8.0 million for Q3 2025, down from $11.6 million in Q3 2024, while non-GAAP net income increased by 45% to $22.4 million [16][23] Business Developments - The acquisition of scPharmaceuticals was completed on October 7, 2025, which is anticipated to diversify and accelerate revenue growth, particularly through the FUROSCIX product [6][7] - The company initiated a Phase 2 clinical trial for MNKD-201 in idiopathic pulmonary fibrosis (IPF) and plans to enroll the first patient in Q1 2026 [5][6] - MannKind's MNKD-101 Phase 3 trial achieved interim enrollment targets ahead of schedule, with an interim analysis expected mid-year 2026 [6][7] Research and Development - Research and development expenses increased by 9% in Q3 2025, primarily due to ongoing clinical trials and patient enrollment [12][17] - The company is advancing its investigational molecule under collaboration with United Therapeutics and has planned pre-clinical studies for Bumetanide DPI [11][17] Cash and Investments - As of September 30, 2025, MannKind had cash, cash equivalents, and investments totaling $286.3 million, with significant cash utilized for the acquisition of scPharmaceuticals [11][12] - The company reported an impairment of available-for-sale investment of $6.4 million for Q3 2025 due to the write-off of the Thirona investment [16][23]

Core Insights - United Therapeutics is a biotechnology company focused on developing treatments for chronic and life-threatening conditions, particularly pulmonary arterial hypertension (PAH) and pediatric neuroblastoma [1] Financial Performance - The company reported a 12% increase in earnings per share for Q3 2025, reaching $7.16, surpassing the Zacks Consensus Estimate of $6.89 [3][6] - Revenues for the quarter were $799.5 million, which was below the expected $818 million but still represented a 7% year-over-year growth [3] Product Sales - Tyvaso sales grew by 10%, while Tyvaso DPI saw a significant increase of 22% [4][6] - The TETON-2 study indicated that Tyvaso improved lung function in patients with idiopathic pulmonary fibrosis (IPF), suggesting potential for future growth [4] Stock Performance - UTHR's stock is currently trading at $455.32, reflecting a notable increase of 9.63% or $39.98 [5][6] - The stock has fluctuated between $415.26 and $479.50 on the trading day, with a market capitalization of approximately $20.59 billion [5]

Core Insights - United Therapeutics reported revenue of $799.5 million for the quarter ended September 2025, reflecting a year-over-year increase of 6.8% [1] - The company's EPS was $7.16, up from $6.39 in the same quarter last year, indicating a positive earnings performance [1] - Revenue fell short of the Zacks Consensus Estimate of $817.8 million, resulting in a surprise of -2.24%, while EPS exceeded expectations by 3.92% [1] Revenue Breakdown - U.S. revenues were $774.8 million, compared to an estimated $810.22 million, marking an 8% increase year-over-year [4] - Revenues from the Rest-of-World segment were $24.7 million, below the estimated $33.09 million, representing a decline of 21.8% year-over-year [4] - Tyvaso generated $470.1 million in U.S. revenue, falling short of the $507.8 million estimate, while Unituxin brought in $46.5 million, below the $62.24 million estimate [4] - Adcirca revenues were $9.7 million, exceeding the $5.49 million estimate, with a significant year-over-year increase of 38.6% [4] - Orenitram revenues reached $131.1 million, slightly above the $124.02 million estimate, reflecting a 15.8% year-over-year increase [4] - Tyvaso DPI revenues were $336.2 million, surpassing the $322.54 million estimate, with a year-over-year growth of 22.4% [4] - Other products generated $6.9 million, exceeding the $5.35 million estimate, with a year-over-year increase of 25.5% [4] Stock Performance - Over the past month, United Therapeutics shares have returned -0.9%, contrasting with the Zacks S&P 500 composite's increase of 3.8% [3] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the broader market in the near term [3]

Financial Data and Key Metrics Changes - United Therapeutics reported record total revenues of $800 million for Q3 2025, representing a 7% growth from Q3 2024 [8] - The company is guiding for a revenue run rate of $4 billion by 2027 [6] Business Line Data and Key Metrics Changes - Continued year-over-year growth in Tyvaso and Orenitram sales, with Tyvaso showing double-digit revenue growth [8] - The launch of Tyvaso DPI is driving a meaningful shift in treprostinil dosing behavior, with an increase in average dosing from nine breaths per treatment to twelve breaths [9] - The introduction of new Tyvaso DPI 80 microgram cartridges is expected to enhance patient convenience and dosing flexibility [10] Market Data and Key Metrics Changes - The company has secured multiple favorable coverage decisions with major payers, validating Tyvaso DPI's market position [11] - The TETON 2 study demonstrated unprecedented treatment benefits for inhaled treprostinil in patients with idiopathic pulmonary fibrosis (IPF), potentially broadening the therapeutic reach [11] Company Strategy and Development Direction - United Therapeutics is actively engaged in business development and anticipates partnerships with major pharmaceutical companies due to its strong data in pulmonary disease [6] - The company is focusing on expanding its product portfolio in pulmonary fibrosis, which presents a larger market opportunity compared to pulmonary hypertension [60] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth profile of Tyvaso, expecting continued growth in both pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) [42] - The management is optimistic about the potential for ralinepag, highlighting its long patent life and synergy with other treatments [28] Other Important Information - The company is preparing for upcoming conferences to present its pipeline and engage with investors [3][4] - The Remunity Pro pump was launched to enhance the experience of parenteral therapy for patients [11] Q&A Session Summary Question: Are you seeing an uptick in diagnoses of IPF patients due to TETON 2 results? - Management noted that physicians are more aggressive in screening for pulmonary hypertension in IPF patients, but it is too early to quantify any direct impact on sales [15][17] Question: What is the market opportunity for ralinepag? - Ralinepag is exceeding expectations, with strong enrollment in its outcomes trial and best-in-class results in six-minute walk distances [26][28] Question: Can you clarify the guidance for a $4 billion run rate by 2027? - Management confirmed the expectation to reach $1 billion in quarterly revenue by 2027, driven by strong IPF results [38][40] Question: What are the commercial dynamics for Tyvaso? - Management indicated no material impact from the launch of Eutrepia, with continued strong growth in patient shipments and prescriber metrics [41][42] Question: What is the status of the TETON PPF enrollment and regulatory path? - Enrollment is about halfway through, and the company is meeting with the FDA to discuss expediting the regulatory review process [50][51] Question: What are the launch plans for the new 80 microgram cartridge for Tyvaso DPI? - The new cartridge is expected to launch within 30 to 60 days, aimed at enhancing patient convenience and dosing [58][60]