Financial Data and Key Metrics Changes - For Q4 2024, consolidated revenues were $111 million, a decline of 3% year-over-year, primarily due to a $9 million decrease from a change in accounting estimate [53][54] - Full-year revenues for 2024 totaled $440 million, down 10% from the previous year, impacted by broader macro pressures on printer sales [56] - Non-GAAP gross margin for Q4 was 31.3%, down from 39.8% in the prior year, with a full-year gross margin of 37.4%, compared to 40.6% in 2023 [58][59] Business Line Data and Key Metrics Changes - Industrial Solutions revenues grew 11% in Q4 to $71 million, driven by strength in printer systems sales and services, particularly in aerospace and defense [54] - Healthcare Solutions reported Q4 revenues of $40 million, down 21% year-over-year, influenced by the accounting change and inventory management issues among dental customers [55][57] - Full-year revenues for Industrial Solutions were $250 million, a decline of 9%, while Healthcare Solutions revenues were $190 million, down approximately 11% [56][57] Market Data and Key Metrics Changes - The aerospace and defense markets showed significant growth, contributing to the uptick in industrial printer sales [54][72] - The dental market is expected to see substantial growth, particularly in the aligner segment, with a projected addressable market of over $1 billion in the U.S. alone by 2029 [33][35] Company Strategy and Development Direction - The company is focusing on in-sourcing manufacturing operations to gain control over product introduction, costs, and quality, which is expected to yield long-term competitive advantages [22][23] - A strategic emphasis is placed on high-reliability markets such as automotive, aerospace, and medical devices, with plans to expand on these markets in future earnings releases [18][19] - The company aims to improve profitability through cost reduction initiatives targeting over $50 million in annualized savings by mid-2026 [42][44] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenging macroeconomic environment affecting customer CapEx spending, but noted signs of stabilization and strengthening demand in Q4 [15][16] - The company expects revenues for 2025 to be flat to modestly growing, with significant improvements in profitability anticipated due to cost actions [50][67] - Management expressed confidence in long-term growth prospects driven by advancements in additive technology and increased customer interest in production applications [20][21] Other Important Information - The company announced a divestiture of its Geomagic Software platform for $123 million, expected to close shortly, which will enhance its balance sheet [45][64] - Cash and cash equivalents at year-end 2024 were $171 million, down from $332 million in the prior year, with significant cash used for debt repurchases [64][65] Q&A Session Summary Question: Update on the industrial vertical and Q1 expectations - Management noted an encouraging uptick in new printer sales in Q4, particularly in high-reliability markets, but expects Q1 to be seasonally weaker [72][75] Question: Focus on dental business and revenue expectations - Management indicated that while aligners will dominate in 2025, significant revenue from other segments like dentures is expected to ramp up in 2026 [80][82] Question: Cost cuts and their impact on growth opportunities - Management confirmed that most cost cuts are permanent and focused on efficiency improvements, with minimal expected revenue impact [114][116] Question: Cash flow expectations and timeline for positive cash flow - Management aims for operating cash flow positivity in 2026, with improvements expected as cost savings are realized [120][121]

Financial Data and Key Metrics Changes - For Q4 2024, consolidated revenues were $111 million, a decline of 3% year-over-year, primarily due to a $9 million decrease from a change in accounting estimate [53][54] - Full-year revenues for 2024 totaled $440 million, down 10% from the previous year, impacted by broader macro pressures on printer sales [56] - Non-GAAP gross margin for Q4 was 31.3%, down from 39.8% in the prior year, with a full-year gross margin of 37.4%, compared to 40.6% in 2023 [58][59] Business Line Data and Key Metrics Changes - Industrial Solutions revenues grew 11% in Q4 to $71 million, driven by strength in printer systems sales and services, particularly in aerospace and defense [54] - Healthcare Solutions reported Q4 revenues of $40 million, down 21% year-over-year, affected by the accounting change and inventory management issues [55] - Full-year revenues for Industrial Solutions were $250 million, a decline of 9%, while Healthcare Solutions revenues were $190 million, down approximately 11% [56][57] Market Data and Key Metrics Changes - The aerospace and defense markets showed significant growth, contributing to the uptick in industrial printer sales [54][72] - The dental market is expected to see substantial growth, particularly in the aligner segment, with a projected addressable market of over $1 billion in the U.S. alone by 2029 [33][35] Company Strategy and Development Direction - The company is focusing on in-sourcing manufacturing operations to gain control over product introduction, costs, and quality, which is seen as a long-term competitive advantage [22][23] - A strategic emphasis is placed on high-reliability markets such as automotive, aerospace, and medical devices, with plans to expand on these markets in future earnings releases [18][19] - The company aims to improve profitability through cost reduction initiatives targeting over $50 million in annualized savings by mid-2026 [42][44] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenging macroeconomic environment affecting customer CapEx spending, but noted signs of stabilization and increased demand in Q4 [15][16] - The company expects revenues in 2025 to be flat to modestly growing, with significant improvements in profitability anticipated due to cost actions [50][51] - Management expressed confidence in long-term growth prospects driven by advancements in additive technology and increased customer interest [20][21] Other Important Information - The company announced a divestiture of its Geomagic Software platform for $123 million, expected to close shortly, which will enhance its balance sheet [45][64] - Cash and cash equivalents at year-end 2024 were $171 million, down from $332 million in the prior year, with significant cash used for debt repurchases [64][65] Q&A Session Summary Question: Update on the industrial vertical and Q1 expectations - Management noted an encouraging uptick in new printer sales in Q4, particularly in high-reliability markets, but expected Q1 to follow a normal seasonal pattern with flat to slightly positive growth [72][75] Question: Focus on dental business and revenue expectations - Management indicated that while the aligner segment will dominate in 2025, significant revenue from other segments like dentures is expected to ramp up in 2026 [80][82] Question: Cost cuts and their impact on growth opportunities - Management confirmed that most cost cuts are permanent and focused on efficiency improvements, with minimal expected revenue impact [114][116] Question: Cash flow expectations and timing for positive cash flow - Management aims for operating cash flow positivity in 2026, with improvements expected from cost savings and operational efficiencies [120][121]

Financial Data and Key Metrics Changes - Fourth quarter revenues were $77 million, a 31% increase over the previous year's fourth quarter [35] - Full year revenues reached $286 million, a 43% increase compared to the prior year [35] - Net income for 2024 was $28 million, or $0.10 per share, compared to a net loss of $12 million, or $0.04 per share for 2023 [41] - The year-end cash position was $203 million, with a debt reduction of $236 million in 2024 [42] Business Line Data and Key Metrics Changes - The endocrine business unit achieved record revenues of $23 million in Q4 and $82 million for the full year [6] - Afrezza net revenue for Q4 was $18 million, an 18% increase, and $64 million for the full year, a 17% increase [37] - V-Go net revenue was approximately $5 million for Q4, a 1% increase, but full year revenues decreased by 4% to $18 million [38] Market Data and Key Metrics Changes - Tyvaso DPI royalties contributed $27 million in Q4, a 28% increase, and $102 million for the year, a 42% increase [36] - DPI-related revenues exceeded $200 million for the year, marking a significant milestone for the Technosphere platform [18] Company Strategy and Development Direction - The company focuses on five key pillars, including two FDA-approved products and funding for pipeline opportunities [5] - The strategy includes expanding the pediatric market for Afrezza and exploring gestational diabetes [11][14] - The company aims to leverage its strong balance sheet to support growth and pipeline development [42] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, highlighting the potential for significant growth in the pediatric market for Afrezza [15] - The company is preparing for upcoming FDA meetings and expects to advance its pipeline projects [33][45] - Management emphasized the importance of effective reimbursement and education strategies for successful product launches [72][75] Other Important Information - The company successfully reduced its debt and improved its cash position, providing a strong foundation for future growth [42] - The collaboration with Amphastar is expected to enhance the pediatric footprint and expedite the filing for pediatric indications [7] Q&A Session Summary Question: Can you talk about margins over the next few quarters? - Management indicated that margins are expected to stabilize as manufacturing utilization increases with Tyvaso DPI and Afrezza [52] Question: Can you provide more details on gross to net discounting and rebates? - Management noted that the current discounting trends are expected to continue throughout the year [54] Question: How do you balance operational profitability with investment in Afrezza? - Management stated that capital deployment will focus on driving the best returns for shareholders while preparing for the pediatric launch [60] Question: What are the critical success factors for Afrezza in pediatrics? - Management identified reimbursement processes, institutional selling capabilities, and education as key factors for success [71][75] Question: What are the expectations for the agreement with CIPLA in India? - Management anticipates that the agreement could lead to significant volume implications and improve overall efficiency [78] Question: What are the safety and efficacy endpoints for the upcoming FDA meeting? - Management plans to discuss various endpoints and trial designs with the FDA, aiming for a solid foundation for future milestones [86][88]

Financial Data and Key Metrics Changes - Fourth quarter revenues were $77 million, a 31% increase over the previous year's fourth quarter. For the full year 2024, revenues reached $286 million, a 43% increase compared to the prior year [35] - Net income for 2024 was $28 million, or $0.10 per share, compared to a net loss of $12 million, or $0.04 per share for 2023. On a non-GAAP basis, net income was $68 million, or $0.25 per share for 2024, compared to $6 million, or $0.02 per share for the prior year [41] - The year-end cash position was $203 million, with a reduction in debt principal by $236 million in 2024, resulting in a remaining debt balance of $36 million [42] Business Line Data and Key Metrics Changes - The endocrine business unit achieved record revenues with Q4 revenue of $23 million and full-year revenue of $82 million [6] - Afrezza net revenue for Q4 was $18 million, an 18% increase due to higher demand and improved growth-to-net adjustments. For the full year 2024, Afrezza revenue was $64 million, a 17% increase over 2023 [37] - V-Go net revenue was approximately $5 million for Q4, a 1% increase over the same quarter in the prior year, but full-year revenues were $18 million, a decrease of 4% due to lower product demand [38] Market Data and Key Metrics Changes - Tyvaso DPI royalties contributed $27 million in Q4, a 28% increase over the same quarter last year. Royalties for the year were $102 million, a 42% increase due to United Therapeutics' increase in net revenue from sales of Tyvaso DPI [36] - DPI-related revenues exceeded $200 million in 2024, marking a significant milestone for the Technosphere platform [18] Company Strategy and Development Direction - The company has five key pillars for future growth, including two FDA-approved products, a strong balance sheet, and funding for novel pipeline opportunities [5] - The strategy includes expanding the pediatric market for Afrezza, with a filing expected in the first half of 2025 and potential approval in the second quarter of 2026 [13][15] - The company is also focusing on the development of clofazamine inhalation suspension and TETON DPI, with ongoing clinical trials and FDA meetings planned [8][9][33] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, highlighting record revenues and a strong pipeline. They emphasized the importance of pediatric opportunities and the potential for significant revenue growth from Afrezza [44][49] - The management team acknowledged the competitive landscape but believes that their products can meet unmet needs in the market, particularly in the IPF space [30][32] Other Important Information - The company transformed its balance sheet in 2024, paying down significant debt and maintaining a robust cash position to support growth initiatives [42] - The company is preparing for a busy travel schedule to engage with stakeholders and promote its growth story [48] Q&A Session Summary Question: Can you talk about margins over the next few quarters? - Management indicated that margins are improving due to better utilization of manufacturing plants and expect steady state margins going forward [52] Question: Can you provide more details on gross to net discounting and rebates? - Management noted that the current discounting trends are expected to continue and that discussions regarding bridging studies are ongoing [54][56] Question: How do you balance operational profitability versus investment in pediatric launch for Afrezza? - Management stated that capital deployment will focus on driving the best return for shareholders while preparing for the pediatric launch [60][62] Question: What are the critical success factors for Afrezza in the pediatric market? - Management identified reimbursement processes, institutional selling capabilities, and education as key factors for success in the pediatric market [71][75] Question: What are the potential contributions from the agreement with CIPLA in India? - Management expects that the agreement could have significant volume implications, improving overall efficiency and cost of goods sold [78] Question: Can you elaborate on the contracting dynamics and potential catch-up in Q1? - Management expects steady state revenue dynamics and does not anticipate major shifts in gross margins or net revenue [81][84] Question: What are the safety and efficacy endpoints for the upcoming FDA meeting regarding 201? - Management outlined plans for a Phase 2 trial with multiple arms to assess different dosing regimens and their efficacy [88][89]

MannKind (MNKD) FY 2025 Conference February 11, 2025 11:20 AM ET Company Participants Michael Castagna - CEOChristopher Prentiss - Chief Financial Officer Conference Call Participants Andreas Argyrides - Managing Director & Senior Analyst - Biotechnology Andreas Argyrides Great. Good morning, everyone, and welcome to Oppenheimer's thirty fifth annual Healthcare Life Science Conference. My name is Andreas Zagredes. I'm one of the senior biotech analysts at Oppenheimer. And today, I have the pleasure to be jo ...

Core Viewpoint - United Therapeutics (UTHR) is currently viewed as a more attractive investment option compared to Catalent (CTLT) for value investors, based on various valuation metrics and analyst outlooks [2][5]. Valuation Metrics - UTHR has a P/B ratio of 2.67, while CTLT has a P/B ratio of 2.89, indicating that UTHR is relatively undervalued compared to CTLT [4]. - The forward P/E ratio for UTHR is 12.93, significantly lower than CTLT's forward P/E of 49.05, suggesting UTHR is more favorably priced [8]. - UTHR's PEG ratio stands at 1.40, while CTLT's PEG ratio is 1.68, further supporting UTHR's position as a better value investment [8]. Analyst Outlook - UTHR holds a Zacks Rank of 2 (Buy), reflecting a positive earnings estimate revision activity, whereas CTLT has a Zacks Rank of 5 (Strong Sell), indicating a less favorable outlook [2][5]. - UTHR has a Value grade of B, while CTLT has a Value grade of D, highlighting the relative strength of UTHR in terms of value metrics [9].