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Apellis Pharmaceuticals Balances Growth With Revenue Headwinds

Tipranks - Sat Mar 7, 6:14PM CST

Apellis Pharmaceuticals ((APLS)) has held its Q4 earnings call. Read on for the main highlights of the call.

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Apellis Pharmaceuticals’ latest earnings call struck a cautiously optimistic tone, with management leaning on strong drug uptake, robust clinical data, and a solid cash position to offset near-term revenue noise. Investors heard a story of growing underlying demand for SYFOVRE and EMPAVELI, but also of accounting headwinds, seasonality, and looming financing choices that could blur the near-term growth picture.

Full-Year Revenue Lifted by One-Time Sobi Payment

Apellis reported 2025 revenue of $1.0 billion, but that headline figure was materially boosted by a $275 million upfront payment from the Sobi royalty repurchase deal. Management stressed that this makes year-over-year comparisons tricky and that investors should focus more on underlying product trends rather than straight-line revenue growth.

SYFOVRE Injections Rise Despite Revenue Headwinds

SYFOVRE showed solid commercial momentum, with total injections growing about 17% year over year in 2025 as demand remained resilient. Q4 SYFOVRE net product revenue reached $155 million and full-year net product revenue was $587 million, underscoring sustained use even as accounting factors weighed on reported sales.

Five-Year GALE Data Underscore SYFOVRE’s Durability

Post-hoc 5-year GALE extension data indicated that SYFOVRE delayed progression of geographic atrophy by roughly 1.5 years in nonsubfoveal disease versus sham. Management argued this long-term clinical benefit strengthens the drug’s differentiation and supports its staying power in a competitive retina market.

EMPAVELI Launch Beats Early Expectations

EMPAVELI’s first full quarter on the market delivered more than 5% market penetration and U.S. net product revenue of $35 million in Q4. Full-year 2025 revenue reached $102 million, supported by 267 cumulative patient start forms by year-end, signaling strong early uptake in an ultra-rare patient population.

Payer Access Supports EMPAVELI Adoption

Roughly 95% of published payer policies now reimburse EMPAVELI to label or with only minimal restrictions, according to management. This broad coverage base is expected to support continued adoption and gives the company a favorable backdrop as it builds toward what it sees as blockbuster potential.

SYFOVRE Maintains Leadership in Geographic Atrophy

In geographic atrophy, Apellis said SYFOVRE retains a durable lead with an estimated 60% market share. That position is underpinned by extensive clinical and real-world evidence, including the new 5-year data, preferred payer status, and ongoing initiatives to streamline practice workflow and drive further adoption.

Pipeline Progress and Upcoming Milestones

The company highlighted pivotal trials for EMPAVELI in FSGS and DGF as key value drivers, alongside a Phase II combo study of SYFOVRE plus APL-3007 with topline results expected in 2027. Additional milestones include an IND for APL-9099 in the second half of 2026, a prefilled syringe submission in the first half of 2026, and OCT-F research availability in the back half of 2026.

Growing Scientific Profile Bolsters Physician Confidence

Apellis’ scientific profile continued to rise, with EMPAVELI data appearing in the New England Journal of Medicine and multiple oral presentations at Macula Society and other meetings. Management believes this level of peer-reviewed and podium exposure enhances clinical credibility and fosters stronger physician receptivity to its platforms.

Cash Cushion Provides Financial Flexibility

The company ended 2025 with $466 million in cash and equivalents, giving it room to fund operations and its pipeline in the near term. Management reiterated its ambition to largely self-fund development, though it acknowledged that capital allocation and balance-sheet choices remain important as the business scales.

Free Goods Weigh on SYFOVRE Reported Revenue

While SYFOVRE volume expanded, full-year revenue was modestly down versus 2024 because of elevated free good utilization in the 12%–14% range during 2025. These free doses, used to support patient access, dampened net revenue even as the total number of injections increased.

Higher Gross-to-Net Ratios Pressure Net Pricing

SYFOVRE gross-to-net adjustments in Q4 ran just above the mid-20% range, and management expects this to move into the high-20% range in 2026. That trend will continue to weigh on net realized revenue, even if list pricing and underlying demand remain stable.

Seasonality and Ultra-Rare Dynamics Add Volatility

Executives cautioned that quarter-to-quarter variability should be expected, citing normal seasonal factors such as Medicare reverifications and holiday patterns. EMPAVELI’s focus on ultra-rare diseases also contributes to lumpier patient flows, adding uncertainty to near-term revenue cadence.

Operating Expense Drift Higher With Trial Spend

Operating expenses climbed to $251 million in Q4 2025 from $239 million a year earlier, reflecting growing R&D and launch activity. For 2026, management forecast modestly higher opex as pivotal trials and milestone payments ramp, though some of that increase should be offset by lower SG&A costs.

Convertible Debt Maturity a Near-Term Capital Consideration

Apellis also flagged a roughly $94 million tranche of convertible debt maturing in September 2026 as a key balance-sheet item. The company is evaluating alternatives to address the obligation, which investors will watch closely as it intersects with cash usage and pipeline funding.

Patient Assistance Dynamics Remain a Wild Card

Third-party co-pay assistance programs began reopening to new patients late in the period, but management said visibility remains limited on how this will evolve. Changes in patient assistance and free goods use could significantly affect net sales over time, adding another layer of uncertainty to revenue forecasting.

One-Time Items Distort Revenue Comparisons

Beyond the Sobi payment, management stressed that one-time factors make 2025 revenue less comparable to prior periods. Investors are encouraged to separate structural product performance from these non-recurring items when assessing underlying growth and valuing the business.

Outlook and Guidance: Stable Pricing, Higher Gross-to-Net

Looking to 2026, Apellis expects SYFOVRE gross-to-net to settle in the high-20% range, with net pricing broadly stable and a modest Q1 inventory reduction tied to Medicare seasonality. Operating expenses should be slightly higher as pivotal trials progress and milestones hit, but management expects to self-fund the pipeline while managing the 2026 convertible debt from a $466 million year-end cash base.

Apellis’ earnings call painted a picture of a company with real commercial traction, differentiated data, and a still-solid balance sheet, but also a complex revenue story in the near term. For investors, the key questions now center on how quickly reported sales can catch up with underlying demand and how management navigates growing R&D spend and upcoming debt maturities without diluting its long-term growth narrative.

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