Core Insights - Apellis Pharmaceuticals reported a fourth-quarter 2025 loss of 47 cents per share, which was wider than the Zacks Consensus Estimate of a loss of 39 cents, compared to a loss of 29 cents in the same quarter last year [1][7] Financial Performance - Total revenues for the fourth quarter were $199.9 million, exceeding the Zacks Consensus Estimate of $194 million, but down 6% year-over-year from $212.5 million in the previous year [2] - Revenues included product sales from Empaveli and Syfovre, along with licensing and other revenues from a collaboration agreement with Sobi [3] - Syfovre sales were $155.2 million, an 8% decline year-over-year, although it slightly surpassed the Zacks Consensus Estimate of $154.2 million [4] - Empaveli recorded sales of $35.1 million, a 50% increase from the previous year, driven by early launch momentum in C3G and IC-MPGN, and also beat the Zacks Consensus Estimate of $28.5 million [9] Market Position and Product Performance - Syfovre holds approximately 60% market share in geographic atrophy treatment, with total injections growing about 17% year-over-year despite the revenue decline attributed to increased use of free goods [5] - Apellis delivered over 89,000 commercial vials and nearly 13,000 samples of Syfovre to doctors in the reported quarter [5] Cost Management - Research and development expenses decreased by 3% year-over-year to $74.2 million, attributed to lower program-specific external costs and personnel costs [10] - Selling, general, and administrative expenses rose by 21% year-over-year to $147.1 million, driven by higher professional fees and personnel costs [11] Cash Position - As of December 31, 2025, Apellis had cash, cash equivalents, and marketable securities totaling $466.2 million, down from $479.2 million as of September 30, 2025, with expectations that this will fund operations to profitability [12] Annual Performance - For the full year 2025, Apellis reported total revenues of $1.0 billion, a 28% increase year-over-year, surpassing the Zacks Consensus Estimate of $998.3 million, which included a one-time $275 million upfront payment from a royalty repurchase agreement [14] - The company reported earnings per share of 20 cents for 2025, compared to a loss of $1.60 per share in 2024, although it missed the Zacks Consensus Estimate of 24 cents [14] Pipeline Developments - Apellis has initiated two pivotal phase III studies of Empaveli for focal segmental glomerulosclerosis and delayed graft function, both of which are rare kidney diseases with no approved therapies [16] - A mid-stage multi-dose study of siRNA candidate APL-3007 in combination with Syfovre is ongoing, with top-line data expected in 2027 [17]

Summary of Swedish Orphan Biovitrum (Sobi) Capital Markets Day 2026 Company Overview - **Company**: Swedish Orphan Biovitrum (Sobi) - **Event**: Capital Markets Day 2026 - **Date**: February 18, 2026 - **Focus**: Progression of the company, development pipeline, and strategic outlook towards 2030 [1][2] Key Points Strategic Outlook - Sobi is transitioning from a focus on hemophilia to a more diversified portfolio, with significant growth in various therapeutic areas [4][5] - The company aims to double its size by 2030, building on a foundation of six major product launches planned by 2028 [24][43] - Sobi has achieved significant EBITDA growth and nearly doubled its business over the last five years, indicating strong operational resilience [8][9] Product Pipeline and Launches - **Current Products**: - Altuviiio (hemophilia A) - Gamifant (HLH) - Aspaveli (nephrology) - Tringalza (FCS) - **Upcoming Launches**: - NASP (uncontrolled gout) expected mid-year - Tringalza in SHDG, already launched in Germany and Austria - Posotenurad (gout) anticipated with the acquisition of Arthrosie Therapeutics [20][21][30][31] Therapeutic Areas - **Gout**: Sobi has two products in this area, with a focus on addressing high unmet medical needs [19][20] - **Sepsis**: The company is exploring interferon gamma-driven sepsis, which affects a significant patient cohort [36][37] - **Chronic Synovitis**: Sobi aims to improve joint health in hemophilia patients, addressing chronic complications through clinical trials [56][57] Market Expansion - Sobi has expanded its global footprint, now covering over 90% of the global rare disease market directly, with new organizations established in key markets like Japan, Korea, Australia, and Brazil [12][39] - The company anticipates that international business could exceed 20% of total revenue by 2030 [39] Commitment to Patients and Sustainability - Sobi ranked as the most reputable company in the rare disease space according to a survey of 518 patient organizations [47] - The company has set scientific-based targets to reduce its carbon footprint while increasing business operations [15][16] Research and Development - Sobi is currently running over 40 clinical trials globally, with a focus on regulatory approvals and scientific leadership [44][45] - The company has achieved 36 regulatory approvals in major markets over the past year, indicating strong growth potential [45][48] Financial Performance - Sobi's financial outlook remains positive, with expectations of sustained growth driven by new product launches and market expansion [3][24] Conclusion - Sobi is positioned for significant growth with a robust pipeline and strategic focus on rare diseases, aiming to double its size by 2030 while maintaining a commitment to patient care and sustainability [43][44]

Sobi Capital Markets Day 2026 18 February 2026 Forward-looking statements In order to utilise the 'Safe Harbor' provisions of the United States Private Securities Litigation Reform Act of 1995, Swedish Orphan Biovitrum AB (publ) is providing the following cautionary statement. This presentation contains forward-looking statements with respect to the financial condition, results of operations and businesses of Swedish Orphan Biovitrum AB (publ), By their nature, forward-looking statements and forecasts invol ...

Core Insights - Apellis Pharmaceuticals reported Q3 2025 earnings of $1.67 per share, exceeding the Zacks Consensus Estimate of $1.03 per share, compared to a loss of 46 cents in the same quarter last year [1][7] - Total revenues for the quarter reached $458.6 million, surpassing the Zacks Consensus Estimate of $366 million and more than doubling from $196.8 million in the prior year, largely due to a $275 million upfront payment from Sobi related to a royalty purchase agreement [2][7] Financial Performance - The revenue growth was primarily driven by the one-time payment from Sobi, raising concerns about the sustainability of core performance, as Syfovre sales declined year-over-year [3][6] - Syfovre sales were reported at $150.9 million, down 1% year-over-year, missing both the Zacks Consensus Estimate of $156.6 million and the internal estimate of $160.4 million [5][7] - Empaveli generated sales of $26.8 million, reflecting a 9% increase from the previous year, and exceeded the Zacks Consensus Estimate of $22.1 million [8] Expenses and Cash Position - Research and development expenses decreased by 23% year-over-year to $68.2 million, attributed to lower external costs and personnel expenses [9] - Selling, general, and administrative expenses rose 17% year-over-year to $142.7 million due to increased commercial activities and personnel costs [9] - As of September 30, 2025, Apellis had cash and marketable securities totaling $479.2 million, up from $370 million as of June 30, 2025, indicating sufficient liquidity to fund operations towards profitability [10] Product Pipeline and Market Position - Syfovre is the market leader in geographic atrophy with over 60% market share, and new patient starts increased by over 52% in Q3 [6] - Empaveli is approved for treating paroxysmal nocturnal hemoglobinuria in the U.S. and Europe, with ongoing regulatory filings for expanded indications [11][12] - Apellis plans to initiate two pivotal phase III studies for Empaveli in rare kidney diseases by the end of 2025 [14] Strategic Developments - A capped royalty purchase agreement with Sobi allows Apellis to receive up to $300 million, with $275 million paid upfront for 90% of ex-U.S. Aspaveli royalties [16]

Core Insights - Apellis Pharmaceuticals (APLS) shares increased by 3.2% following a capped royalty agreement with Sobi, allowing Apellis to receive up to $300 million for 90% of its future ex-U.S. royalties from Aspaveli [1][5] - The deal significantly enhances Apellis' financial position, providing operational flexibility with cash and marketable securities totaling $358.4 million as of the end of Q1 2025 [2] - The agreement includes a $275 million upfront payment and potential milestone payments of up to $25 million upon EU approval for Aspaveli in two severe kidney diseases [3][5] Financial Impact - The capped royalty deal will allow Sobi to receive 90% of ex-U.S. royalties until performance-based caps are met, after which all royalties will revert to Apellis [4] - Year-to-date, APLS shares have decreased by 44%, contrasting with a 3.4% decline in the industry [4] Regulatory Developments - Apellis and Sobi are seeking label expansion for Empaveli, with FDA and EU reviews currently underway for C3 glomerulopathy and primary immune complex membranoproliferative glomerulonephritis [7] - A decision from the FDA is anticipated on July 28, 2025, while the EU decision is expected by year-end [7] Clinical Study Results - The phase III VALIANT study demonstrated a statistically significant 68% reduction in proteinuria for patients treated with Empaveli compared to placebo, indicating its effectiveness in C3G and IC-MPGN [9] - The study also showed that patients experienced stabilized kidney function, with 71% achieving complete clearance of C3c staining intensity [10][12]