Continued strong demand, with more than 100,000 vials (commercial and sample) distributed to date; growth in week-over-week demand returned starting in August

Permanent J-code effective as of October 1, and more than 95% of all Medicare payers now covering SYFOVRE

Up to 45% reduction of nonsubfoveal GA lesion growth observed between Months 24-30 compared to projected sham in the GALE extension study

Estimated rate of retinal vasculitis continues to be rare at 0.01% per injection

Apellis expects approximately $74 million in preliminary U.S. net product revenue for SYFOVRE in the third quarter and approximately $160 million in preliminary total U.S. net product revenue for SYFOVRE since launch in March 2023 through September 30, 2023.ⁱ

Approximately 37,000 commercial vials and 10,000 samples were distributed to physician practices in the third quarter; more than 100,000 total vials have been delivered to date.

Continued strong demand; week-over-week growth returned starting in August, with weekly orders from both new and existing sites of care.

Permanent J-code effective as of October 1, which will help ensure accurate and efficient reimbursement of SYFOVRE.

93% of Medicare Advantage payers and 100% of Original Medicare (fee-for-service) payers are now covering SYFOVRE.

Apellis estimates that 94% of the U.S. GA population is covered by Medicare.

The estimated revenue figures are preliminary and based on management’s estimate as of the date of this press release and are subject to completion of the Company’s financial closing and review procedures.

In the GALE long-term extension study, which was reported in July 2023, SYFOVRE continued to slow GA progression between Months 24 and 30 compared to projected sham (all p-values nominal):

SYFOVRE reduced GA lesion growth with both monthly (39%; p<0.0001) and every-other-month (EOM) (32%; p<0.0001) treatment.

SYFOVRE reduced nonsubfoveal GA lesion growth with monthly (45%; p<0.0001) and EOM (33%; p=0.0023) treatment.

New functional data from post-hoc microperimetry analysis demonstrating that SYFOVRE prolonged foveal sensitivity in the Phase 3 OAKS study will be presented as a late-breaking presentation at the EURETINA Congress on Friday, October 6 at 12:24 CEST.

In the GALE study at 30 Months, the safety profile of SYFOVRE continued to be consistent with previously reported Phase 3 data.

The estimated real-world rate of retinal vasculitis remains rare, at 0.01% per injection.

In total, there have been 10 confirmed events of retinal vasculitis (seven occlusive, three non-occlusive) and two suspected events.

Since the last update on August 22, there was one new confirmed event that occurred in early August and two new suspected events, one that occurred in mid-August and one in September. Of the two events that were previously classified as suspected, one event has been confirmed and the other was adjudicated to not be retinal vasculitis.

Of the confirmed retinal vasculitis events, six patients have recovered vision either fully or partially, three patients have severe vision impairment that is unlikely to be resolved, and one patient’s outcome is pending. Visual outcomes in both suspected events are pending.

All suspected retinal vasculitis events reported to Apellis are independently evaluated and adjudicated by two external sources: a panel of four retina/uveitis experts and an independent reading center as well as Apellis’ internal safety and medical teams.

Apellis submits all reported adverse events to the U.S. FDA consistent with reporting guidelines for drug manufacturers. Apellis and the American Society of Retina Specialists (ASRS) are in close communication regarding reported cases of retinal vasculitis.

Rudnicka AR, Jarrar Z, Wormald R, et al. Age and gender variations in age-related macular degeneration prevalence in populations of European ancestry: a meta analysis. Ophthalmology 2012;119:571–580.

Wong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health 2014;2:e106–116.

Lindblad AS, et al, and AREDS Research Group. Arch Ophthalmol. 2009;127(9):1168-1174.

SYFOVRE is contraindicated in patients with ocular or periocular infections, and in patients with active intraocular inflammation

Endophthalmitis and Retinal Detachments

Intravitreal injections, including those with SYFOVRE, may be associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering SYFOVRE to minimize the risk of endophthalmitis. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately.

Neovascular AMD

In clinical trials, use of SYFOVRE was associated with increased rates of neovascular (wet) AMD or choroidal neovascularization (12% when administered monthly, 7% when administered every other month and 3% in the control group) by Month 24. Patients receiving SYFOVRE should be monitored for signs of neovascular AMD. In case anti-Vascular Endothelial Growth Factor (anti-VEGF) is required, it should be given separately from SYFOVRE administration.

Intraocular Inflammation

In clinical trials, use of SYFOVRE was associated with episodes of intraocular inflammation including: vitritis, vitreal cells, iridocyclitis, uveitis, anterior chamber cells, iritis, and anterior chamber flare. After inflammation resolves, patients may resume treatment with SYFOVRE.

Increased Intraocular Pressure

Acute increase in IOP may occur within minutes of any intravitreal injection, including with SYFOVRE. Perfusion of the optic nerve head should be monitored following the injection and managed as needed.

Most common adverse reactions (incidence ≥5%) are ocular discomfort, neovascular age-related macular degeneration, vitreous floaters, conjunctival hemorrhage.

To report suspected adverse reactions, contact Apellis Pharmaceuticals, Inc. at 1-833-866-3346 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.