Apellis Pharmaceuticals, a biotech focused on complement-mediated diseases [20], delivered standout financial results for the third quarter of 2025 – yet its stock took a beating. The company reported Q3 revenue of $458.6 million, more than doubling from $196.8 M in the same quarter last year [21]. This record top-line was boosted by a one-time $275 M licensing deal with partner Sobi [22], which paid Apellis upfront for future ex-U.S. royalties on Aspaveli (Empaveli’s overseas brand). Thanks largely to this deal, Apellis swung to a net profit of $215.7 M (versus a $57.4 M loss a year ago) [23].
However, the market’s reaction was harsh. Shares of APLS plunged over 20% after earnings – falling to around $24 – as investors focused on management’s guidance that the current profitability is not yet permanent [24]. Despite beating analyst forecasts (EPS $1.67 vs. $1.03 est.) [25], Apellis indicated it expects to return to net losses in coming quarters, once the one-off Sobi windfall is absorbed. This cautious outlook spooked traders, sending the stock on a steep slide in Thursday’s session. The sharp drop erased a rally that had lifted Apellis shares to about $29–30 in late October [26]. Prior to earnings, the stock had climbed on optimism from an analyst upgrade and data updates, but the post-earnings “whiplash” highlights Wall Street’s jitters about Apellis’s trajectory going forward.
Syfovre injection volumes have risen steadily each quarter (gray portions indicate free doses provided) [27] [28]. Q3 2025 saw ~101,000 total doses shipped, including ~15,000 free samples, as Apellis works to expand the geographic atrophy treatment market.
Apellis’s flagship drug Syfovre (pegcetacoplan injection) was the first therapy approved for geographic atrophy (GA) – an advanced form of macular degeneration that causes progressive vision loss. Syfovre remains the market leader in GA, capturing an estimated 60%+ market share in the U.S. [29]. In Q3, Syfovre generated $150.9 M in U.S. sales [30], accounting for the bulk of Apellis’s product revenue. However, year-over-year sales were roughly flat (Q3 2024 also saw ~$152 M) [31] – a sign that growth has plateaued after the initial launch phase. On a quarterly basis, use is still rising: Apellis reported about 101,000 doses delivered in Q3 (including ~15k free doses), representing a 4% increase in injection volume from Q2 [32]. The company says Syfovre’s clinical profile – with effects that deepen over time and flexible dosing – and its broad insurance coverage have helped maintain uptake [33]. Indeed, roughly 52% of new GA patients who started treatment in Q3 went on Syfovre [34], indicating it’s capturing over half of new prescriptions.
Yet headwinds are emerging for Syfovre. By Apellis’s estimates (and those of partner Astellas), only ~10–15% of diagnosed GA patients have begun treatment with any GA drug so far [35] – meaning the vast majority of patients remain untreated. This represents a huge growth opportunity, but also raises questions about uptake barriers. Goldman Sachs analysts recently warned that some retina specialists are not fully convinced that slowing GA lesion growth yields tangible quality-of-life improvements for patients [36]. In other words, if doctors and patients don’t see meaningful preservation of vision, they may be reluctant to undergo costly, frequent eye injections. Additionally, Astellas’s Izervay (a rival GA therapy approved shortly after Syfovre) is vying for market share. Goldman cited key opinion leader feedback suggesting a “superior risk-benefit perception” for Izervay among some physicians [37]. Notably, Apellis faced safety concerns last year when a rare side effect (ocular inflammation and blood clots) was linked to Syfovre, though the company implemented mitigation measures. Still, perception of risk could tilt some doctors toward the competitor. Another challenge has been patient drop-off due to funding hurdles: Apellis offers co-pay assistance, but Goldman noted that charitable support programs for GA patients have recently been scaled back, leading to higher attrition rates among patients who cannot afford continuous treatment [38].
Apellis is working to expand Syfovre’s reach and reinforce its value proposition. The company is investing in educating physicians and patients on the benefits of treating GA earlier to preserve vision. It also continues to provide free starter doses (as reflected by ~$15 M worth of free vials in Q3) to encourage adoption [39]. Looking ahead, Apellis is already developing a next-generation GA therapy: a combination of Syfovre with an investigational siRNA drug (APL-3007) that more fully suppresses the destructive complement pathway in the retina [40]. A Phase 2 trial of this combo is ongoing, and could potentially boost efficacy beyond Syfovre alone if successful. This shows Apellis’s commitment to defending its lead in GA – a market that could grow substantially if more patients opt for treatment. For now, Syfovre provides a steady revenue base, but Wall Street clearly wants to see re-acceleration of its growth in coming quarters to justify Apellis’s valuation.
Empaveli’s New Indication and Pipeline Progress
While GA is Apellis’s highest-profile market, the company is also making waves in rare disease therapeutics. Its systemic C3 inhibitor Empaveli (pegcetacoplan) was originally approved for paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder. In July 2025, Empaveli gained an important label expansion: the FDA approved Empaveli as the first-ever treatment for two rare kidney diseases, C3 glomerulopathy (C3G) and primary IC-MPGN, in patients age 12 and up [41]. These ultra-rare conditions (fewer than ~5,000 U.S. patients) involve a similar complement system dysfunction that Empaveli targets. Approval was backed by impressive Phase 3 trial results – a 68% reduction in proteinuria (protein in urine) and stabilization of kidney function in treated patients [42] [43]. Apellis launched Empaveli in nephrology over the summer, and by the end of Q3 had 152 patient start forms for C3G/IC-MPGN on file [44]. This includes ~50 patients rolled over from a pre-approval access program, indicating a core base of early adopters. Apellis’s CEO Cedric Francois heralded the approval as a major milestone that “adds to Empaveli’s robust profile” and could make it “the treatment of choice” in these diseases [45].
Commercial uptake in rare diseases tends to build gradually, but Empaveli’s initial traction in kidney clinics is encouraging. In Q3, Empaveli’s U.S. sales came in at $26.8 M, a modest increase from $24.6 M in the prior-year quarter [46]. Beyond PNH and these new kidney indications, Apellis sees further expansion opportunities. The company plans to initiate two pivotal trials by late 2025: one in focal segmental glomerulosclerosis (FSGS) and another in delayed graft function (DGF), both kidney disorders with high unmet need linked to complement activation [47]. If Empaveli can succeed in additional renal diseases, it would broaden the drug’s reach and reinforce Apellis’s franchise in complement inhibition. Notably, Apellis’s partner Sobi (Swedish Orphan Biovitrum) is handling Empaveli (branded “Aspaveli”) outside the U.S. Sobi expects a European approval decision by late 2025 for C3G/IC-MPGN [48] – which would trigger up to $25 M in milestone payouts to Apellis [49] and, more importantly, open another market for growth.
Overall, Apellis now has two approved products (Syfovre and Empaveli) covering four indications across ophthalmology and nephrology – all leveraging its core strategy of inhibiting C3, a central protein in the immune complement cascade [50]. This pipeline-in-a-product approach means successes in new indications can amplify revenue without entirely new drugs. However, it also means the company’s fortunes ride on the continued clinical benefits of pegcetacoplan across different diseases. So far, data has been strong, and Apellis is bolstering that with long-term studies (for instance, 52-week results from the VALIANT trial in C3G/IC-MPGN were presented at a kidney conference, reinforcing Empaveli’s sustained efficacy [51]). As Apellis broadens its label and pursues new trials, it is gradually transforming into a multi-indication biotech with a growing addressable market – from a niche PNH base to larger populations like GA and beyond.
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