RT John Collison (@collision)Dave Ricks has been at @EliLillyandCo for 20% of its 150-year history. He came to the pub, poured his own Guinness, and gave us a 2-hour state of the pharma union: drug prices, clinical trials, patent clocks, the rise of generics, Chinese peptides, compounding pharmacies, the US healthcare system, and how the broad success of GLP-1s have transformed Lilly's business. If you've never heard Dave speak before, you're in for a treat.Timestamps:00:00 Intro05:08 Making R&D decisions10 ...

Core Insights - ANI Pharmaceuticals reported Q3 CY2025 results exceeding market revenue expectations, with a year-on-year sales increase of 53.6% to $227.8 million [1][3] - The company's full-year revenue guidance of $863.5 million at the midpoint is 1.8% above analysts' estimates, and its non-GAAP profit of $2.04 per share surpassed consensus estimates by 15.2% [1][5] Financial Performance - Revenue for Q3 was $227.8 million, beating analyst estimates of $214.1 million, reflecting a 53.6% year-on-year growth and a 6.4% beat [5] - Adjusted EPS was reported at $2.04, exceeding analyst estimates of $1.77 by 15.2% [5] - Adjusted EBITDA reached $59.6 million, surpassing analyst estimates of $55.24 million, with a margin of 26.2% [5] - The company raised its full-year revenue guidance to $863.5 million from $830.5 million, marking a 4% increase [5] - Full-year Adjusted EPS guidance was lifted to $7.51 at the midpoint, a 4.7% increase [5] - EBITDA guidance for the full year is set at $224.5 million at the midpoint, above analyst estimates of $221.9 million [5] - Operating margin improved to 15.9%, up from -13.8% in the same quarter last year [5] - Market capitalization stands at $1.87 billion [5] Business Segments and Growth Drivers - The significant growth was attributed to strong performance in the Rare Disease and Generics segments, with Cortrophin Gel nearly doubling net revenue compared to the prior year [3] - The company experienced record new patient starts and expanded prescriber adoption, particularly in pulmonology and ophthalmology [3] - Management emphasized strong underlying demand and addressable patient populations as key drivers of success [3] Future Outlook - Updated guidance reflects expectations of continued growth, particularly from the Rare Disease portfolio, with a focus on Cortrophin Gel [4] - The company aims to expand clinical evidence, invest in commercial initiatives, and enhance patient convenience [4] - Management expressed confidence in the multi-year growth trajectory of Cortrophin and acknowledged ongoing efforts to support ILUVIEN's adoption [4] - Future business development opportunities are anticipated to expand the Rare Disease segment [4]

Financial Data and Key Metrics Changes - The company reported a total revenue increase of 22% to $64 billion, driven by strong demand across all five operating segments [11][12] - Operating earnings grew by 37% and EPS increased by 36%, with Q1 EPS reported at $2.55 [9][12] - Gross profit rose by 22% to $2.3 billion, while SG&A expenses increased by 14% to $1.5 billion [11][12] - The effective tax rate for Q1 was 21.9%, about 100 basis points better than the previous year [12] Business Line Data and Key Metrics Changes - **Pharmaceutical and Specialty Solutions**: Revenue increased by 23% to $59 billion, with segment profit up 26% to $667 million, driven by brand and specialty pharmaceutical sales [12][13] - **GMPD**: Revenue grew by 2% to $3.2 billion, with profit increasing by $38 million to $46 million, supported by volume growth from existing customers [14] - **Other Businesses**: Revenue surged by 38% to $1.6 billion, with segment profit rising by 60% to $166 million, reflecting strong demand across all three businesses [15][16] Market Data and Key Metrics Changes - The company experienced strong demand trends across its pharmaceutical segment, particularly in brand and specialty products, with approximately 6 percentage points of revenue growth attributed to GLP-1 sales [12][13] - The GMPD segment saw over 6% revenue growth in the U.S. [14] - The integration of ADS into At Home Solutions is progressing well, with earlier realization of planned synergies [15][16] Company Strategy and Development Direction - The company is focused on expanding its Specialty Alliance platform and enhancing its capabilities through the acquisition of Solaris Health, which is expected to close shortly [6][11] - Investments are being made to modernize the national pharmaceutical distribution network and improve operational efficiency [25][26] - The company aims to leverage its MSO platforms to broaden its impact in key therapeutic areas such as autoimmune, urology, and oncology [26][27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's momentum and raised full-year EPS guidance to a range of $9.65 to $9.85, reflecting 17% to 20% growth from the prior year [11][18] - The company anticipates continued strong demand in the pharmaceutical sector and expects to benefit from the integration of recent acquisitions [18][19] - Management highlighted the importance of maintaining service levels and operational performance to capitalize on market opportunities [58][100] Other Important Information - The company generated $1.3 billion in adjusted free cash flow during Q1 and ended the quarter with a cash position of $4.6 billion [17] - The company is increasing its adjusted free cash flow guidance to a new range of $3 billion to $3.5 billion for the full year [18] Q&A Session Summary Question: What is the broader momentum going forward and what has driven the upside in Q1? - Management noted strong demand across the board and highlighted that the Specialty business was trending above historical levels, contributing significantly to growth [36][43] Question: Does the guidance include Rite Aid from CVS? - Management indicated that while they do not support Rite Aid, they are likely picking up a greater share of that volume due to strong performance across various customers [49][51] Question: How do you view the growth outlook for the Pharmaceutical and Specialty Solutions segment? - Management emphasized that they are focused on what they can control, expecting strong utilization and continued demand, while also factoring in contributions from acquisitions [56][58] Question: What is the impact of recent policy changes in D.C.? - Management stated that they align with the administration's intent to ensure access to affordable healthcare, which could drive utilization positively [52][53] Question: Can you discuss the onboarding of distribution businesses from recent acquisitions? - Management confirmed that the onboarding of distribution for ION and GIA is going well and is included in the guidance, while Solaris Health's distribution will be addressed once the acquisition closes [94][96] Question: What opportunities arise from competitors divesting their businesses? - Management noted that they continue to focus on service levels and performance, which positions them favorably in the competitive landscape [99][100]

Financial Data and Key Metrics Changes - BrightSpring reported total revenue of $3.3 billion for Q3 2025, representing a 28% year-over-year growth [9][24] - Adjusted EBITDA for the quarter was $160 million, an increase of 37% compared to the same period last year, with an EBITDA margin of 4.8% [9][26] - Cash flow from operations exceeded $100 million in Q3, with leverage declining to 3.3x [10][27] Business Line Data and Key Metrics Changes - Pharmacy Solutions revenue was $3.0 billion, growing 31% year-over-year, while Provider Services revenue reached $367 million, increasing 9% year-over-year [9][24] - Within Pharmacy Solutions, infusion and specialty revenue was $2.4 billion, reflecting a 42% growth from the prior year, while home and community pharmacy revenue was approximately flat at $590 million [24][26] - Provider Services segment adjusted EBITDA grew 16%, with home healthcare revenue increasing 12% year-over-year [18][24] Market Data and Key Metrics Changes - Home healthcare average daily census was 29,592, representing a 3% increase year-over-year, with hospice revenue increasing approximately 15% [18][19] - Specialty pharmacy scripts grew approximately 40% in Q3, driven by strong performance in both brand limited distribution drugs (LDDs) and generics [15][16] Company Strategy and Development Direction - BrightSpring aims to leverage its scaled platform in home and community healthcare to differentiate itself in the market [7] - The company is focused on quality and continuous improvement, with high patient satisfaction scores across service lines [11][12] - Future growth strategies include expanding chronic infused therapy offerings and optimizing go-to-market strategies in pharmacy [17][19] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing operational execution and continuous improvement driving financial results [8] - The company anticipates closing the community living divestiture transaction in Q1 2026, which is subject to regulatory approvals [8][10] - Management expects to achieve adjusted EBITDA guidance of $605 million-$615 million for 2025, reflecting a growth of 31.5%-33.7% over 2024 [30] Other Important Information - BrightSpring will host an Investor Day on March 17 in Louisville to discuss company strategy and service line prospects [21][22] - The company is implementing operational initiatives to enhance efficiency and has seen positive impacts from targeted growth investments [25][88] Q&A Session Summary Question: On the pacing of new drug launches - Management confirmed that the pipeline remains robust, with expectations of 16 to 18 launches over the next 12 to 18 months [32][33] Question: Sources of accretion for the Amedisys transaction - Management indicated that integration of operations and applying best practices will drive incremental margin and profit [41][42] Question: EBITDA per script increase sustainability - Management noted that higher growth in specialty scripts, which have the highest gross profit, contributed to the increase [44][45] Question: Impact of community living divestiture delay - Management stated that the delay is due to regulatory processes but remains optimistic for a Q1 closure [71] Question: Future opportunities in specialty pharmacy - Management highlighted ongoing focus on rare and orphan therapies and the growth potential in both acute and chronic therapies [94][95]

Industry Trend - Patents for active ingredients in Ozempic and Wegovy are expiring, potentially leading to cheaper weight-loss drugs globally [1] - Indian generics giants could play a key role in making slimming drugs more affordable worldwide [1]

All right, look at some new data uh from RSM. They say about more than 40% of the branded drugs we use here in the US, they come from Europe, about 18% of gener. So really, how big of an impact will these tariffs have not only on pricing but availability.>> Well, I think uh you know what was really causing investors the most concern was that this was completely uncharted territory. We've never seen tariffs in the pharma sector before. Um and um so it was a lot of sort of a guessing game of what the final ra ...

Financial Performance and Guidance - ANI Pharmaceuticals projects net revenues of $768 million to $793 million for 2025, representing a year-over-year growth of 25% to 29%[10] - The company anticipates adjusted non-GAAP EBITDA of $195 million to $205 million in 2025[10] - Adjusted non-GAAP diluted EPS is expected to be between $627 and $662 in 2025[26] - Generics revenue in Q1 2025 reached $99 million, up 41% year-over-year and 26% quarter-over-quarter[69, 70] Rare Disease Business - Cortrophin Gel net revenue is projected to be $265 million to $274 million in 2025, a 34% to 38% increase from 2024[26] - ILUVIEN and YUTIQ net revenue is expected to be $97 million to $103 million in 2025[26] - Acute gouty arthritis flares now account for approximately 18% of Cortrophin Gel usage[23] Strategic Focus and Operations - Approximately 95% of total company revenues are from products sold in the U S [10] - Over 90% of total company revenues are sourced from finished goods manufactured in the U S [10] - The company has $150 million in cash as of March 31, 2025[10]

Financial Data and Key Metrics Changes - ANI Pharmaceuticals reported record fourth quarter and full year 2024 results, raising 2025 guidance for total revenues and adjusted non-GAAP EBITDA [10][11] - 2025 revenue is now expected to be between $756 million and $776 million, representing growth of 23% to 26% over 2024 [10][62] - Adjusted non-GAAP EBITDA for 2025 is projected to be between $190 million and $200 million, reflecting growth of 22% to 28% over 2024 [10][62] Business Line Data and Key Metrics Changes - Rare Disease was the primary growth driver in 2024, with Cortrophin Gel generating close to $200 million in sales [11][12] - Generics business achieved 12% revenue growth, marking the third consecutive year of double-digit growth [12] - Fourth quarter revenues for Rare Disease and Brands were $106.9 million, up 97% year-over-year, with Rare Disease revenues more than doubling to $87 million [53][55] Market Data and Key Metrics Changes - The overall ACTH market is expected to have grown about 25% to approximately $660 million in 2024 [38] - There are currently fewer than 5,000 patients on therapy for ILUVIEN and YUTIQ, with an estimated addressable patient population 6 to 10 times higher [89][113] - The demand for Cortrophin Gel increased across all targeted specialties, including neurology, rheumatology, nephrology, pulmonology, and ophthalmology [15][35] Company Strategy and Development Direction - The company aims to broaden its presence in the rare disease space, as evidenced by the acquisition of Alimera Sciences [12][11] - A core strategic rationale for the Alimera acquisition was to add synergistic assets and leverage existing infrastructure to unlock the potential of ILUVIEN and YUTIQ [17][51] - The company plans to continue investing in R&D and commercial initiatives to drive growth in its Rare Disease business [45][51] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth prospects for Cortrophin Gel and the overall ACTH market, despite current access issues for ILUVIEN and YUTIQ [89][114] - The company anticipates a typical Q4 to Q1 revenue drop for Cortrophin Gel, followed by strong sequential growth in subsequent quarters [63][90] - Management highlighted the importance of addressing unmet needs in autoimmune disorders and the potential for significant market expansion [39][40] Other Important Information - The company has expanded its U.S. ophthalmology sales team from 30 to 46 representatives to promote ILUVIEN, YUTIQ, and Cortrophin Gel [20][48] - A prefilled syringe for Cortrophin Gel is under FDA review, expected to launch in the second quarter of 2025 [44][45] - The company has taken steps to enhance supply security for ILUVIEN and YUTIQ through partnerships and capacity expansions [22][100] Q&A Session Summary Question: Business development and M&A capacity - Management indicated a thoughtful approach to leverage ratios, historically keeping it under three, and expressed intent to pursue additional business development while maintaining balance sheet health [76][78] Question: Gout's contribution to Cortrophin sales - Currently, 15% of Cortrophin's volume comes from gout, which is seen as a gateway indication for new prescribers [80] Question: Access issues for Alimera assets - Management acknowledged access issues for ILUVIEN and YUTIQ due to funding shortfalls in patient assistance programs but remains confident in long-term growth prospects [88][89] Question: Seasonality impact on Cortrophin - Typical Q4 to Q1 dynamics are expected, with a drop in sales followed by sequential growth, supported by strong early trends [90] Question: Transitioning supply from EyePoint to Siegfried - Management confirmed that supply transitions are being managed carefully, with inventory buildup and a focus on maintaining supply security [100][101]