If you are interested in keeping up to date with stocks making moves within the biotech, pharma and healthcare industries, and understanding the key trends and catalysts driving valuations ahead of the market, why not subscribe to my weekly newsletter via my Investing Group, Haggerston BioHealth ?My last two ratings on Apellis Pharmaceuticals, Inc. ( APLS ), the Waltham, Massachusetts-based pharma company and complement system specialist, have been Holds, the first beingEdmund Ingham is a biotech consultant ...

Core Insights - Apellis Pharmaceuticals announced positive results from the Phase 3 VALIANT study for EMPAVELI (pegcetacoplan) in treating C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), rare kidney diseases [1][4] Company Overview - Apellis Pharmaceuticals is a biopharmaceutical company focused on complement science, developing therapies for serious diseases, including the first treatment for C3G and primary IC-MPGN in patients aged 12 and older [25] Study Results - The VALIANT study demonstrated a statistically significant 68% reduction in proteinuria in EMPAVELI-treated patients compared to placebo [7] - EMPAVELI-treated patients showed stabilization of kidney function with a difference of +6.3 mL/min/1.73 m compared to placebo [7] - A majority of EMPAVELI-treated patients achieved zero C3 staining intensity, indicating complete clearance of C3 deposits [7][6] Safety Profile - The VALIANT study reported favorable safety and tolerability for EMPAVELI, with common adverse reactions including infusion site reactions, pyrexia, and nasopharyngitis [3][22] - No cases of meningococcal infection due to encapsulated bacteria were reported across over 2,750 patient-years of experience with EMPAVELI [3] Market Potential - Approximately 50% of patients with C3G and primary IC-MPGN may experience kidney failure within five to ten years of diagnosis, highlighting the urgent need for effective treatments [8] - The diseases are estimated to affect around 5,000 individuals in the U.S. and up to 8,000 in Europe, indicating a significant market opportunity for EMPAVELI [8]

Question-and-Answer SessionCedric FrancoisCo-Founder, President, CEO & Director Yes. Thank you, John, and thank you for inviting us again. This is a wonderful conference. So the launch is going exactly the way the commercial team had told us it would go. And that is really gratifying to see because it was a feat as many people on the buy and sell side will appreciate to understand the epidemiology of this disease, right? Patients with C3G and IC-MPGN, it's a rare disease, of course, are highly spread out ac ...

Summary of Apellis Pharmaceuticals FY Conference Call Company Overview - **Company**: Apellis Pharmaceuticals (NasdaqGS:APLS) - **Focus**: Development and commercialization of therapies for rare diseases, specifically targeting C3G and IC-MPGN with their product Empaveli, and geographic atrophy with Syfovre Key Points on Empaveli Launch - **Launch Progress**: The launch of Empaveli is proceeding as expected, with the commercial team effectively identifying the epidemiology of C3G and IC-MPGN, which are rare diseases [3][5] - **Patient Estimates**: The estimated patient population for C3G is around 5,000, aligning with internal expectations, contrasting with competitors' larger estimates [5] - **New Patient Starts**: In Q3, there were 152 new patient starts, with expectations of reaching 225 by year-end [6] - **Patient Identification**: The identification of new patients is facilitated through various sources, including patient organizations and claims data, leading to a robust pipeline of potential patients [7] - **Treatment Urgency**: There is a higher urgency for treatment in pediatric and post-transplant settings, where Apellis is the only approved product [8][10] - **Nephrologist Engagement**: Pediatric nephrologists are highly engaged and informed about Empaveli, with a good uptake in the transplantation segment [11][12] - **Long-term Adoption**: The adoption of Empaveli is expected to grow as nephrologists gain experience with the drug, with positive feedback from those who have used it [13][15] Key Points on Syfovre and Geographic Atrophy - **Market Perception**: The market for Syfovre has faced challenges, particularly due to funding issues affecting patient access to treatments for wet AMD, which indirectly impacted geographic atrophy patient enrollment [20][22] - **Patient Segments**: There are three key patient segments for Syfovre: advanced geographic atrophy, early geographic atrophy, and patients with wet macular degeneration [24] - **Long-term Data**: The GALE trial data indicates that treatment can save patients 1.5 years of vision over five years, which is significant for patient outcomes [25] - **Prefilled Syringes**: The introduction of prefilled syringes is anticipated to improve the adoption of Syfovre by streamlining the administration process [28][29] - **Market Position**: Apellis maintains a competitive position in the market, with prescription rates stabilizing around mid-50% for Syfovre compared to competitors in the low 45% range [33] Additional Insights - **Seasonality and Cadence**: There is no expected significant seasonality affecting new patient starts for Empaveli, but the conversion from start forms to paying customers may take time [19] - **Future Outlook**: The company aims to help physicians reimagine the treatment landscape for geographic atrophy, focusing on long-term data and patient outcomes [26][27] - **Combination Studies**: Apellis is exploring combination therapies, such as the Abelast 3007, which aims to enhance treatment efficacy and dosing frequency [34] This summary encapsulates the key insights from the Apellis Pharmaceuticals FY Conference Call, highlighting the company's strategic focus, market dynamics, and future growth opportunities.

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Apellis Pharmaceuticals (NasdaqGS:APLS) FY 2025 Conference December 02, 2025 02:30 PM ET Company ParticipantsCedric Francois - CEOTim Sullivan - CFOConference Call ParticipantsYigal Nochomovitz - AnalystYigal NochomovitzOkay. Ready to go. All right. So, Apellis, welcome. Great to see you. So, of course, we have Cedric Francois, CEO and also the co-founder and president of the company, and Tim Sullivan, CFO. So, welcome for those listening on the webcast and then in person. I'm Yigal Nochomovitz, biotech ana ...

Apellis Pharmaceuticals (NasdaqGS:APLS) FY 2025 Conference December 02, 2025 02:30 PM ET Company ParticipantsCedric Francois - CEOTim Sullivan - CFOConference Call ParticipantsYigal Nochomovitz - AnalystYigal NochomovitzOkay. Ready to go. All right. So, Apellis, welcome. Great to see you. So, of course, we have Cedric Francois, CEO and also the co-founder and president of the company, and Tim Sullivan, CFO. So, welcome for those listening on the webcast and then in person. I'm Yigal Nochomovitz, biotech ana ...

Apellis Pharmaceuticals (NasdaqGS:APLS) FY 2025 Conference December 02, 2025 02:30 PM ET Speaker1Okay. Ready to go. All right. So, Apellis, welcome. Great to see you. So, of course, we have Cedric Francois, CEO and also the co-founder and president of the company, and Tim Sullivan, CFO. So, welcome for those listening on the webcast and then in person. I'm Yigal Nachamovitz, biotech analyst at Citi. Been covering Apellis since the very beginning, a long time. So, it's great to be continuing to follow the st ...

Core Insights - Apellis Pharmaceuticals Inc. is highlighted as a promising investment opportunity due to the positive long-term benefits of its drug SYFOVRE for treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD) [1][3] Group 1: Drug Efficacy and Study Results - A post hoc analysis of the Phase 3 GALE extension study indicates that SYFOVRE can delay GA lesion growth by approximately 1.5 years with both monthly and bi-monthly administration compared to sham treatment [2][3] - SYFOVRE is the first FDA-approved therapy for geographic atrophy, targeting C3 to control the complement cascade effectively [3] Group 2: Disease Impact - Geographic atrophy is a progressive and irreversible disease that leads to blindness, affecting over 1 million Americans and 5 million people globally [2]

Core Insights - Apellis Pharmaceuticals Inc. is considered one of the most oversold biotech stocks to invest in, with a Neutral rating maintained by Mizuho and a price target reduction from $24 to $19 [1] Financial Performance - In Q3 2025, Syfovre's revenue was $150.9 million, slightly down from $152.0 million in Q3 2024, but there was a 4% quarter-over-quarter increase in injections [2] - Apellis Pharmaceuticals reported that Syfovre holds over 60% market share in the geographic atrophy (GA) treatment area, with 52% of new patient starts in Q3 2025 [2] - Mizuho has lowered its revenue projections for Syfovre, now estimating a peak annual revenue of about $800 million, which is 25-30% lower than consensus estimates [2] Company Overview - Apellis Pharmaceuticals Inc. is a commercial-stage biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutic compounds for diseases with high unmet needs [2]