Apellis Pharmaceuticals' Q3 2025 Earnings Call: Contradictions Emerge on Market Growth, Revenue & Market Share, Co-Pay Assistance, EMPAVELI Launch, and SYFOVRE Sales

Date of Call: October 30, 2025

Financials Results

• Revenue: $459M total Q3 revenue, includes $275M upfront from Sobi; SYFOVRE net product revenue $151M; EMPAVELI net product revenue $27M

Guidance:

• SYFOVRE: Q4 total injection growth expected low- to mid-single-digit; Q4 revenue broadly in line with Q3.
• Gross-to-net for SYFOVRE in low- to mid-20% range, expected to trend slightly above that in Q4.
• Expect a modest channel build in Q4 and stable inventory quarter-over-quarter.
• EMPAVELI: expect ≥225 cumulative start forms by year-end; EAP patients to convert to commercial by year-end (4–6 week start time).
• Full-year operating expenses expected in line with 2024; cash ~$475M post Sobi upfront, sufficient to fund to profitability.

Business Commentary:

* SYFOVRE Sales and Market Share: - SYFOVRE net product revenue for Q3 was $151 million, with an estimated 4% injection growth. - While SYFOVRE maintains its leading position with 52% of new patient starts and more than 60% of the overall GA market, growth is expected to be steady in the near term. - The slower growth is attributed to a wait-and-see approach by retina specialists and obstacles in patient access due to co-pay assistance and funding issues.

• EMPAVELI Launch and Market Expansion:
• EMPAVELI achieved 152 patient start forms in Q3, including approximately 50 from the expanded access program.
• This launch expands the addressable market by 5,000 patients, marking a breakthrough therapy with broad efficacy across key disease control measures.

• The strong feedback and differentiated efficacy are expected to drive treatment decisions and support the growth in adoption, particularly in nephrology practices.

• Operating Expenses and Financial Strategy:

• Apellis reported operating expenses of $235 million for Q3, down from $244 million in the same quarter last year.
• The reduction in operating expenses reflects disciplined cost management, prioritizing commercialization of core products, and continued investment in innovation.

• The company ended the quarter with $475 million in cash and cash equivalents, ensuring financial flexibility for future developments and supporting sustainable profitability.

• Pipeline and Future Initiatives:

• Apellis is expanding EMPAVELI's development into rare kidney diseases, FSGS and DGF, with plans to initiate pivotal trials by year-end.
• The company is investing in AI tools and a prefilled syringe for SYFOVRE to enhance physician and patient experience, anticipating these initiatives to drive broader adoption and market growth.
• These strategic investments are aimed at leveraging complement-mediated disease expertise to positively affect the lives of patients with serious illnesses.

Sentiment Analysis:

Overall Tone: Positive

• Management highlighted progress: "Total revenue for the third quarter was $459 million" (includes $275M Sobi upfront); FDA approved EMPAVELI expanding the addressable market by ~5,000 patients; SYFOVRE delivered ~4% injection growth and ~52% of new patient starts; management said they "remain confident in our pricing and access position heading into 2026."

Q&A:

• Question from Jonathan Miller (Evercore ISI): Do you still expect past this first bolus of patients that kidney is going to be a distributed or slow indication to penetrate? Do you expect that to continue? Or is your strong penetration into these top practices indicative of the launch could be more rapid than people expect?
  Response: Expect the initial bolus to conclude by year-end, then a steady, consistent gradual ramp into next year rather than a rapid broad penetration.

• Question from Anupam Rama (JPMorgan): On SYFOVRE sampling — samples on higher end of 10%–15% range; should we expect this to stabilize or could it continue to creep up as you expand the market?
  Response: Free-goods/sampling programs are monitored to ensure appropriate use and patient access; programs will be managed as the market grows.

• Question from Steven Seedhouse (Cantor Fitzgerald): Of the ~152 patient start forms, can you break out C3G vs IC-MPGN and pre- vs post-transplant, adult vs adolescent? Any switches from Fabhalta and market share sense?
  Response: Starts span the broad label across indications; we are seeing switches from Fabhalta driven by efficacy, tolerability and dosing convenience (EMPAVELI twice-weekly vs competitor twice-daily).

• Question from Yigal Nochomovitz (Citigroup): Are the ~50 EAP patients on commercial drug now or still in process? Of the other ~102 starts, what fraction have actually started and how long have they been on drug since end of July?
  Response: ~50 EAP patients are being converted with goal of commercial product by year-end; many new starts remain in process—typical time from start form to treatment is ~4–6 weeks.

• Question from Elizabeth (Goldman Sachs): On the 4–6 week time frame from start form to treatment for EMPAVELI, when could we see acceleration and what might it normalize to?
  Response: Working to shorten the 4–6 week start time via payer policy updates and operational improvements, but no firm timeline provided.

• Question from Kathy (Jefferies): SYFOVRE revenue flat QoQ ($151M) and 4% injection growth—do you see this as a floor before efficacy data/PFS; when to expect return to growth given patient funding issues?
  Response: Q3 demand grew ~4% (largely driven by free goods headwind); long-term reacceleration expected from initiatives such as the prefilled syringe and other education tools—timing to be clarified early next year.

• Question from Colleen Hanley (Robert W. Baird): You mentioned learnings on prescribers' habits in C3G/IC-MPGN—can you elaborate and implications for the launch?
  Response: Physicians are aligned with the broad label and data; focus now is on educating beyond top accounts to scale adoption across more prescribers.

• Question from Ellen Horste (TD Cowen): Any progress with the Good Days co-pay assistance charity and visibility on funding for new GA patients?
  Response: Largest charity is open for existing patients but not for new patients; no expected change to patient assistance this quarter.

• Question from Judah Frommer (Morgan Stanley): How did patient start forms come in versus internal expectations, and is sampling self-driven or competitive?
  Response: Start forms met internal expectations; free-goods usage reflects true patient demand/access needs (not a pure competitive sampling dynamic).

• Question from Ryan Deschner (Raymond James): When was EMPAVELI first made available for the C3G/IC-MPGN launch and any timeline for a topline readout for the Phase II SYFOVRE + APL-3007 study?
  Response: EMPAVELI launched the week of July 28; the APL-3007 combination trial is enrolling with a one-year endpoint and no readout timing guidance was provided.

• Question from Derek Archila (Wells Fargo): Prefilled syringe — when could it be available and will it expand market or shift share? Any post-quarter trends on EMPAVELI start forms?
  Response: Prefilled syringe is in clinical testing, meets quality expectations and should broaden adoption though no launch timing was given; no additional update on EMPAVELI starts beyond the year-end start-form guidance.

• Question from Biren Amin (Piper Sandler): Given Izervay's revised guidance and your low- to mid-single-digit injection growth, is this due to undertreatment and what shifts physician dynamics?
  Response: Affordability and co-pay/charity funding gaps are a significant headwind depressing GA treatment; Apellis is pursuing AI diagnosis tools, a prefilled syringe and targeted education to address undertreatment.

• Question from Douglas Tsao (H.C. Wainwright): Are co-pay operational challenges creating practice headaches or patient frustration? And has availability of EMPAVELI led to more biopsies/diagnoses of C3G/IC-MPGN?
  Response: Co-pay/access complexity creates operational burden for practices and can delay or pause new patient starts; conversely, having an available treatment (EMPAVELI) motivates clinicians to diagnose more actively (biopsy) to identify treatable patients.

• Question from Graig Suvannavejh (Mizuho): Can you provide EMPAVELI revenue breakout by PNH vs new kidney indications and how the 152 start forms translated into kidney revenue?
  Response: No formal revenue breakout will be provided; PNH has been roughly ~$20M in recent quarters and new-kidney contribution should be inferred from start-form timing (4–6 weeks to treatment), but no explicit split was given.

• Question from Lisa Walter (RBC Capital Markets): Any color on pivotal trial design for FSGS and DGF?
  Response: Pivotal programs for FSGS and DGF have been initiated; no further design details beyond clinicaltrials.gov were provided.

Contradiction Point 1

Market Growth and Share

It involves differing perspectives on the company's market growth and competitive positioning, which are key indicators for investors and stakeholders.

Do you still expect slow penetration of kidney indications, or could EMPAVELI's launch be faster due to strong adoption in top practices? - Jonathan Miller (Evercore ISI)

2025Q3: David expects the launch to go through the initial bolus of patients and then transition to a steady, consistent growth into 2023. Feedback from nephrology communities has been positive, which is encouraging for the launch. - David Acheson(CRO)

Can you explain the discrepancy between your mid-single-digit GA market growth and your competitor's 20%+ quarter-on-quarter growth attributed to insurance claims for majority market share? - Jonathan Miller (Evercore)

2025Q2: We have clear leadership to be clear on every single metric. On revenue, new patient share, overall market share on vials and injections, on preferred payer coverage and also present at academic conferences. We're here at ASRS in Long Beach. We have 5 volume presentations, our competitor has 0. The data that has been presented is still is by now 4 years old. We have a much larger database set than what our competitor uses. Ours is representative of approximately 50% of injections in the offices. - Cedric Francois(CEO)

Contradiction Point 2

Revenue and Market Share Distribution

It involves differing perspectives on the distribution of revenue and market share, which are crucial for understanding the company's financial performance and competitive positioning.

What was the revenue from PNH versus new rare kidney indications for EMPAVELI? - Graig Suvannavejh (Mizuho Securities USA LLC)

2025Q3: Tim mentions that PNH revenue has been relatively static at around $20 million. The new kidney indications are expected to grow, but detailed revenue contributions are not broken out due to their complexity. - Timothy Sullivan(CFO)

Given your competitor's 20%+ QoQ growth in the GA market using insurance claims to secure their claimed majority share, how do you reconcile this with your mid-single-digit growth? - Jonathan Miller (Evercore)

2025Q2: We have clear leadership to be clear on every single metric. On revenue, new patient share, overall market share on vials and injections, on preferred payer coverage and also present at academic conferences. We're here at ASRS in Long Beach. We have 5 volume presentations, our competitor has 0. The data that has been presented is still is by now 4 years old. We have a much larger database set than what our competitor uses. Ours is representative of approximately 50% of injections in the offices. - Cedric Francois (CEO)

Contradiction Point 3

Co-Pay Assistance and Patient Access

It involves the impact of co-pay assistance funding and patient access to SYFOVRE, which directly affects the company's revenue and market penetration.

Will SYFOVRE sampling stabilize or continue to rise as the market expands? - Anupam Rama (JPMorgan Chase & Co)

2025Q3: We maintain regular reviews of sampling programs and prioritize patient access. The sampling programs are utilized to ensure patients have access to necessary products. - David Acheson(EVP-Commercial)

Is the sample increase due to co-pay assistance, and will it continue? - Biren Amin (Piper Sandler)

2025Q1: The increase in samples is due to the funding issue. We continue to work on transitioning patients from samples to commercial doses by educating offices on benefit design. - Cedric Francois(CEO) and David Acheson(EVP-Commercial)

Contradiction Point 4

EMPAVELI's Market Launch and Patient Transitions

It pertains to the expectations and strategies surrounding the market launch of EMPAVELI and the transition of patients from SYFOVRE to EMPAVELI, which impacts the company's product revenue and market share.

Do you still expect slow adoption for kidney indications, or could EMPAVELI’s launch be faster than expected due to adoption in top practices? - Jonathan Miller (Evercore ISI)

2025Q3: David expects the launch to go through the initial bolus of patients and then transition to a steady, consistent growth into 2023. Feedback from nephrology communities has been positive, which is encouraging for the launch. - David Acheson(EVP-Commercial)

What are your launch plans for C3G and IC-MPGN, and how does co-pay assistance impact them? - Yigal Nochomovitz (Citigroup Inc.)

2025Q1: Our field teams are ramping up for a major launch. We emphasize the urgency for treatment and seamless access. The benefit of every other month dosing is a strong differentiator. - David Acheson(EVP-Commercial)

Contradiction Point 5

SYFOVRE Sales and Growth Prospects

It involves differing expectations regarding SYFOVRE's sales growth and market share, which are crucial for investors to assess the company's financial health and competitive positioning.

Can you provide an update on SYFOVRE's growth trajectory? - Timothy Arcuri (UBS)

2025Q3: We are confident in SYFOVRE's growth trajectory and long-term potential. We expect SYFOVRE's long-term potential to be reinvigorated through various initiatives. - Timothy Sullivan(CFO)

How should we view SYFOVRE's 2025 cadence given potential label updates and formulary expansion? - Salveen Richter (Goldman Sachs)

2024Q4: SYFOVRE's revenue should grow gradually over the next 2 years as we drive towards the peak of the addressable market. - David Acheson(CRO)