Financial Performance - The company reported record revenue growth of 29% year over year, with adjusted EBITDA increasing by 9% year over year [6][21][22] - Net product revenues reached $188 million, with Jornay PM contributing $32.6 million, BELBUCA at $52.6 million (up 1%), Xtampza at $52.6 million (up 18%), and Nucynta franchise at $46.4 million (up 4%) [22][23] - GAAP net income was $12 million, down from $19.6 million in the prior year, while non-GAAP adjusted earnings per share increased to $1.68 from $1.62 [23][24] Business Lines Performance - Jornay PM prescriptions grew by 23% year over year, with record quarterly revenues of $32.6 million [6][22] - The pain portfolio generated record revenues of $155.4 million, up 7% year over year, with all three core pain medicines showing growth [6][18] Market Data - Jornay PM's market share in the long-acting branded methylphenidate market grew to 23%, up 7.6 percentage points year over year [15] - The company expanded its prescriber base for Jornay PM to over 26,000, a 23% increase compared to the previous year [15][35] Company Strategy and Industry Competition - The company aims to build a diversified biopharmaceutical portfolio, focusing on significant growth for Jornay PM and maximizing the pain portfolio [4][9] - The company is committed to strategic capital deployment, including share repurchases and business development opportunities [7][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver on financial and strategic commitments, raising 2025 revenue guidance to approximately 19% growth year over year [8][28] - The company is focused on increasing awareness of Jornay PM among healthcare providers and patients, particularly in the adult ADHD market [12][17] Other Important Information - The company completed a $25 million accelerated share repurchase program and announced a new $150 million share repurchase program [7][26] - The company ended the quarter with $222.2 million in cash and cash equivalents, while reducing debt by $16.1 million [10][24] Q&A Session Summary Question: What is the target goal for additional prescribers for Jornay PM by year-end? - Management indicated that there is no specific goal for prescribers but expects continued growth in prescriber breadth [34][35] Question: What are the specific levers for growth in the third quarter? - Management highlighted the importance of raising awareness among healthcare providers and patients to drive prescriptions [51] Question: Any updates on generic competition for the pain portfolio? - Management noted that there are no immediate threats from generics due to regulatory and manufacturing barriers [53][56] Question: How does the company view potential business development opportunities? - Management stated a commitment to disciplined assessment of potential opportunities, focusing on commercial-ready assets [60][61]

Financial Data and Key Metrics Changes - AbbVie reported adjusted earnings per share of $2.97, which is $0.11 above the guidance midpoint [6] - Total net revenues were $15.4 billion, exceeding expectations by over $400 million, reflecting a 6.5% operational growth [7][36] - The company raised its full-year revenue guidance to $60.5 billion, an increase of $800 million, and adjusted EPS guidance to between $11.88 and $12.08 [8][37] Business Line Data and Key Metrics Changes - Immunology revenues exceeded $7.6 billion, with SKYRIZI global sales at $4.4 billion, up 61.8% operationally [10][11] - RINVOQ global sales reached $2 billion, up 41.2% operationally, with strong uptake in IBD [12][13] - Neuroscience revenues were approximately $2.7 billion, up 24% operationally, driven by Vraylar and UBRELVY [20] - Oncology revenues were nearly $1.7 billion, with IMBRUVICA sales down 9.5% and VENCLEXTA sales up 8.3% [16][17] - Aesthetics revenues were nearly $1.3 billion, down 8% operationally, impacted by economic challenges [18] Market Data and Key Metrics Changes - SKYRIZI continues to capture robust market share in psoriatic disease, leading in the US across all lines of therapy [10][11] - HUMIRA global sales were over $1.1 billion, down 58.2% due to biosimilar competition [15] - The aesthetics market is performing below historical levels, with economic challenges affecting consumer sentiment [18][19] Company Strategy and Development Direction - AbbVie is focused on advancing its pipeline and strategic transactions to support long-term growth, with over 30 business development transactions executed since last year [9] - The company is enhancing its immunology pipeline with innovative therapies and technologies, including the acquisition of Capstan Therapeutics [26][27] - AbbVie aims to leverage its global aesthetics commercial footprint to sell obesity drugs in the future [72][73] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong outlook for 2025 and beyond, driven by the performance of SKYRIZI and RINVOQ [10][41] - The company is well-positioned to manage potential impacts from tariffs and is investing in US manufacturing capacity [56] - Management highlighted the importance of external innovation and strategic investments to drive growth in the next decade [66] Other Important Information - AbbVie announced impressive Phase III results for RINVOQ in alopecia areata, indicating significant commercial potential [24][97] - The company is actively working to stabilize and grow the dermal filler market amid economic challenges [99] Q&A Session Summary Question: Impact of Stellara biosimilar on SKYRIZI and RINVOQ - Management noted that while there may be some impact, the core momentum for SKYRIZI and RINVOQ is driven by outstanding data and breadth of indications [44][46] Question: Confidence in SKYRIZI and RINVOQ long-term guidance - Management indicated strong performance and momentum, with updates to long-term guidance expected at appropriate times [52][54] Question: Commercial opportunity for alopecia areata - Management highlighted that the new indications for RINVOQ could add approximately $2 billion to peak year sales, with significant potential for momentum [97] Question: Impact of GLP-1s on aesthetics - Management stated that the overall effect is net neutral, with some potential tailwinds for dermal fillers due to patient concerns about facial aesthetics [90]

Financial Data and Key Metrics Changes - The company reported total revenues of $15.8 billion, a decrease of 2% both nominally and excluding foreign exchange impact [16] - Earnings per share were $2.13, reflecting strong fundamentals despite revenue decline [23] Business Line Data and Key Metrics Changes - Oncology sales, particularly from Keytruda, increased by 9% to $8 billion, driven by robust demand in both US and international markets [17] - Sales of Gardasil decreased by 55% to $1.1 billion, primarily due to a decline in China [18] - Winrevir achieved global sales of $336 million, with cumulative sales exceeding $1 billion in just over a year since launch [20] - The Animal Health business saw an 11% increase in sales, reflecting higher demand across all species [21] Market Data and Key Metrics Changes - Global growth, excluding Gardasil sales in China, was 7%, driven by strength in oncology and animal health [16] - The company noted that Gardasil channel inventories in China remain elevated, with soft demand impacting sales [28] Company Strategy and Development Direction - The company announced a multi-year optimization initiative to redirect $3 billion in cost savings from lower growth areas to higher potential areas [25] - The acquisition of Verona Pharma is expected to enhance the cardiopulmonary program and reflects the company's commitment to transformative science [10][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in returning to growth in 2025, supported by new product launches and a strong pipeline [7][26] - The company anticipates challenges in the second half of the year, particularly with Gardasil in Japan and China [28] Other Important Information - The company is conducting over 80 phase three studies across various therapeutic areas, indicating strong clinical momentum [8] - The FDA approved Inflonsia for RSV prevention in infants, marking a significant milestone for the company [9] Q&A Session Summary Question: Context for Cadence outcomes - Management indicated that the most important signal for success in the Cadence study is the PVR, with the six-minute walk also being significant [51][52] Question: Ex-US uptake of Winrevir - Management noted that growth in the ex-US market is expected to accelerate in the second half of the year, with recent approvals in Japan [61][62] Question: Impact of $3 billion restructuring - Management clarified that the $3 billion will be reinvested into high-potential areas, with a focus on funding the pipeline and commercial launches [67][69] Question: Gardasil demand dynamics - Management expressed confidence in Gardasil's safety and efficacy, but noted challenges in the CDC purchasing dynamics and soft demand in China [72][78] Question: Valuation for Chinese partner Lenovo - Management confirmed that the Lenovo program is progressing as planned, with no issues reported [88][89]

Financial Data and Key Metrics Changes - Total revenue grew 32% to $18,500,000 compared to $14,000,000 in the same quarter last year [22] - Net income was $4,000,000, a significant improvement from a net loss of $2,900,000 in the prior year [6][27] - Basic earnings per share increased to $0.65 from a loss of $0.52 in the same quarter last year [6][27] - Adjusted EBITDA rose to $3,900,000 from $900,000 in the prior year [6][27] Business Line Data and Key Metrics Changes - ADHD portfolio net revenue increased by 25% to $15,400,000 compared to $12,300,000 in Q3 of the previous year [22] - Pediatric portfolio net revenue surged 77% to $3,100,000 from $1,700,000 in the same quarter last year [22][14] Market Data and Key Metrics Changes - ADHD prescriptions were approximately 94,000 during the third quarter, reflecting a return to normalized market conditions following previous shortages [10] - The pediatric business saw a rebound due to a return to growth plan and improved payer coverage [14][15] Company Strategy and Development Direction - The company has focused on its prescription pharmaceutical business, halting clinical development and selling its consumer health business [7] - Future growth is expected to be driven by leveraging the A2 RxConnect platform and pursuing additional in-licensed or acquired products [8][19] - The company aims to maintain a balanced focus on both ADHD and pediatric portfolios for growth [18] Management's Comments on Operating Environment and Future Outlook - Management expressed satisfaction with the operational and financial performance, highlighting the achievement of positive income from operations for the second consecutive quarter [5][6] - The company is optimistic about future growth, particularly in the ADHD and pediatric segments, and is focused on operational efficiencies [18][19] Other Important Information - Gross margin for the third quarter was 69%, down from 74% in the same quarter last year, with expectations for improvement as inventory issues are resolved [22][25] - The company paid down $2,500,000 in long-term debt during the quarter, maintaining compliance with all debt covenants [29] Q&A Session Summary Question: Were there any one-time effects in the ADHD or pediatric business this quarter? - Management confirmed that the growth was organic and driven by optimization efforts, with no one-time effects impacting the numbers [35] Question: What are the expectations for the ADHD franchise moving forward? - Management expects continued growth in the ADHD franchise, supported by optimization efforts and a balanced focus on both ADHD and pediatric products [36][37] Question: What is the potential for the pediatric business? - Management indicated realistic growth expectations but does not foresee returning to a $25,000,000 annual business, aiming for something north of current levels [39][40] Question: What are the main factors affecting business development and asset acquisition? - The main gating factor is finding the right asset that complements the company's capabilities and therapeutic focus, with a preference for commercial-ready products [41][42] Question: What impact do tariffs have on the company? - Management stated that tariffs have a minimal impact as all ADHD products are manufactured in the U.S., with only small components sourced internationally [46][47] Question: Can you elaborate on the return to growth plan for the pediatric business? - The plan involved deploying the sales force against more pediatric targets and expanding coverage through creative contracting with payers [54][56] Question: What is the breakeven revenue number based on current operating expenses? - The breakeven revenue is approximately $15,000,000 on a quarterly basis, with a cash-based breakeven closer to $13,100,000 [61][62]

Core Viewpoint - Recordati S.p.A. has approved its 2025-2027 three-year plan, targeting significant revenue and income growth through organic expansion and strategic acquisitions [1][2][7] Financial Targets - Net Revenue is projected to be between €3,000 million and €3,200 million, driven by strong organic growth in both Specialty & Primary Care and Rare Diseases segments [3][5] - EBITDA is expected to range from €1,140 million to €1,225 million, maintaining a margin of at least 38% [5] - Adjusted Net Income is forecasted to be between €770 million and €820 million [5] Growth Drivers - The Specialty & Primary Care business is anticipated to grow at a mid-single digit CAGR of approximately 3.5-4.5% from 2024 to 2027, while the Rare Diseases segment is expected to achieve a double-digit CAGR of 17-20% during the same period [3] - The company plans to leverage recent FDA approvals, such as the expanded label for Isturisa, increasing its peak sales target for the product to between €550 million and €650 million [4] Business Development Strategy - Recordati will continue to focus on organic growth, complemented by business development and M&A activities, while investing in lower-risk pipeline opportunities [1][7] - The company aims to maintain a net debt level between 1.7-2.0 times EBITDA, with flexibility for temporary increases for high-quality acquisitions [6] Recent Performance - In Q1 2025, Recordati reported revenue of €680 million, reflecting an 11.9% increase compared to Q1 2024, with notable growth in both business units [8] - Specialty and Primary Care revenue was €408.6 million, up 3.3%, while Rare Diseases revenue reached €254.8 million, a 29.0% increase [8]

Financial Data and Key Metrics Changes - In Q4 2024, net product revenues reached a record $181.9 million, up 22% year-over-year [42] - For the full year 2024, net product revenues were a record $631.4 million, up 11% year-over-year [42] - Adjusted EBITDA grew by 9% year-over-year, reaching a record $401.2 million for 2024 [47] - GAAP net income for Q4 was $12.5 million, down from $31.9 million in Q4 2023, while full year net income was $69.2 million, up from $48.2 million in 2023 [46] Business Line Data and Key Metrics Changes - Jornay PM generated net revenue of $29.3 million in Q4 2024, with full year pro forma net revenue of $100.7 million, expected to exceed $135 million in 2025, representing over 34% growth [12][42] - Belbuca achieved net revenue of $55.2 million in Q4 2024, up 12% year-over-year, and $211.3 million for the full year, up 16% year-over-year [43] - Xtampza ER net revenue was $51.5 million in Q4, up 6% year-over-year, and $191.3 million for the full year, up 8% year-over-year [44] - Nucynta franchise net revenue was $41.8 million in Q4, down 11% year-over-year, and $176.5 million for the full year, down 7% year-over-year [45] Market Data and Key Metrics Changes - The ADHD market has been growing at an average rate of 6% from 2019 to 2024, with stimulant medications comprising almost 90% of the market [21] - Jornay PM prescriptions grew 29% year-over-year in Q4 2024, with a total of 636,200 prescriptions for the full year, up 31% compared to 2023 [12][27] Company Strategy and Development Direction - The company aims to drive significant growth in Jornay, maximize the pain portfolio, and strategically deploy capital to create shareholder value [16][19] - The focus is on expanding and diversifying the portfolio through business development, particularly in ADHD and neuropsychiatry [62] - The company plans to invest in raising awareness of Jornay among healthcare professionals and patients, with targeted investments expected to impact growth primarily in 2026 and beyond [31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strong financial position, with net leverage expected to be less than one time by the end of 2025 [53] - The company anticipates a modest decline in revenue in Q1 2025 due to typical dynamics, but expects over 10% adjusted EBITDA growth for the year [50][51] - Management highlighted the importance of disciplined capital deployment and the potential for significant growth in the ADHD market [62] Other Important Information - The company repurchased $60 million in shares during 2024, with $90 million remaining in the share repurchase program authorized through Q2 2025 [52] - The acquisition of Ironshore Therapeutics and its lead medicine Jornay PM is seen as a strategic move to enter the neuropsychiatry market [9][66] Q&A Session Summary Question: Path for Collegium over the next three to five years and update on business development opportunities - Management indicated a focus on both organic and inorganic growth, particularly in ADHD and neuropsychiatry, while maintaining a strong financial position [58][62] Question: Synergies realized from the integration of Ironshore - Management noted typical synergies related to senior management overlap and G&A but emphasized the strategic investment in Jornay as the primary focus [66] Question: Impact of the NO PAIN Act on the pain treatment category - Management stated that the NO PAIN Act had no impact on their portfolio as it primarily focuses on inpatient settings, while their products are retail-based chronic pain therapies [67] Question: Sales force expansion and coverage of ADHD prescribers - The expanded sales force will cover 60% of the long-acting ADHD market, targeting approximately 23,000 healthcare professionals [79] Question: Long-term planning for generic entry of Belbuca and Nucynta - Management expressed confidence that no party currently has the necessary combination of ingredients and regulatory clearance to launch competitive generics against their pain products [81]