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]

MannKind (NasdaqGM:MNKD) 2025 Conference November 19, 2025 06:30 AM ET Company ParticipantsMichael Castagna - CEOMichael CastagnaWhich insulin and IU patient will get? Insulin and IU patient will get. I'll talk about in a second. We've initiated a IB trial here for nintedanib. That'll be mainly in the U.S. to satisfy the FDA to go into phase III. We have INFLOW 2, which will be going out ex-U.S., and that will be the bridge to the phase III dosing. I'll start off with the newest acquisitions, and that's whe ...

Liquidia Corp (NasdaqCM:LQDA) 2025 Conference November 18, 2025 08:00 AM ET Company ParticipantsMike Kaseta - CFO and COORoger Jeffs - CEO and Board MemberConference Call ParticipantsAmy Lee - Biotech AnalystAmy LeeOkay, awesome. Hey, everyone, thanks so much for attending the Liquidia Fireside Chat. Day two of the conference. The weather in London is, you know, it's getting a little chilly, but it's good for staying awake. So my name is Amy Lee. I am a biotech analyst at Jefferies. I have the pleasure of w ...

United Therapeutics (NasdaqGS:UTHR) 2025 Conference November 18, 2025 07:00 AM ET Company ParticipantsJames Edgemond - CFO and TreasurerHarry Silvers - Manager of Investor RelationsConference Call ParticipantsRoger Song - Senior Equity Research AnalystRoger SongWelcome, everyone, to Jefferies Linden Healthcare Conference 2025. My name is Roger Song, one of the Senior Analysts who covers Mid-Cap Biotech in the U.S. It is my pleasure to have the fireside chat with our next company, United Therapeutics, James ...

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]

Financial Performance - Total revenue reached $800 million, representing a 7% year-over-year increase compared to Q3 2024[30] - Tyvaso DPI and nebulized Tyvaso combined revenue increased by 10% year-over-year to $478 million[30, 58] - Orenitram revenue increased by 16% year-over-year to $131 million[30, 58] - Remodulin revenue decreased slightly by 2% year-over-year to $126 million[30, 58] - Unituxin revenue decreased by 22% year-over-year to $48 million[30, 58] - The company's trailing twelve months (TTM) operating cash flow is $16 billion, and it holds $43 billion in cash, cash equivalents, and marketable investments[31] Pipeline Development - TETON-2 study of nebulized Tyvaso for Idiopathic Pulmonary Fibrosis (IPF) met its primary endpoint[37] - TETON-1 study data for Tyvaso in IPF in the U S and Canada is expected in the first half of 2026[37, 40, 42] - The ADVANCE OUTCOMES study of Ralinepag for Pulmonary Arterial Hypertension (PAH) is fully enrolled with 728 patients, and data is expected in the first half of 2026[47, 50]