Apellis Pharmaceuticals Is Maintained at Outperform by Baird

Apellis Pharmaceuticals, Inc. APLS incurred third-quarter 2024 loss of 46 cents per share, wider than the Zacks Consensus Estimate of a loss of 32 cents. The company had incurred a loss of $1.17 per share in the year-ago quarter.

Total revenues in the third quarter amounted to $196.8 million and missed the Zacks Consensus Estimate of $199 million. In the year-ago quarter, the company had reported revenues of $110.4 million.

The top line jumped 78.3% year over year, owing to higher sales of Syfovre (pegcetacoplan injection) in the third quarter.

Syfovre was approved for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration by the FDA in February 2023.

Year to date, shares of Apellis have plunged 53.1% compared with the industry’s decline of 3.8%.

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More on APLS' Q3 Results

Revenues in the third quarter included product sales of the marketed drugs — Empaveli (pegcetacoplan) and Syfovre — and licensing and other revenues under the collaboration agreement with Sobi.

Syfovre recorded sales of $152 million in the third quarter, which surged 101.8% year over year, owing to continued strong demand. However, Syfovre's sales missed the Zacks Consensus Estimate of $162 million but slightly beat our model estimate of $151.7 million.

Apellis delivered more than 84,500 commercial vials and nearly 4,000 samples of Syfovre to doctors in the third quarter. As of Sept 30, 2024, the total number of doses of the drug delivered since launch was 420,000.

The potential approval and successful launch of Syfovre in additional geographies will add an incremental stream of revenues to APLS in the future.

Empaveli recorded sales of $24.6 million in the third quarter, up 2.9% from the year-ago quarter’s figure, owing to continued high patient compliance rates of 97%. Empaveli sales were in line with the Zacks Consensus Estimate and beat our model estimate of $23.9 million.

Empaveli is approved in the United States for the treatment of paroxysmal nocturnal hemoglobinuria. The drug is also approved in Europe under the brand name Aspaveli for the same indication.

Licensing and other revenues came in at $20.3 million, up 81.3% year over year.

Research and development expenses increased 11.6% from the prior-year quarter’s level to $88.6 million. This was due to an increase in program-specific external costs and other external costs.

General and administrative expenses totaled $122 million, down 16.2% year over year. This was due to decreases in personnel-related costs, marketing activities, office costs, and professional and consulting fees.

As of Sept 30, 2024, Apellis had cash, cash equivalents and marketable securities worth $396.9 million compared with $360.1 million as of June 30, 2024. APLS expects its cash balance, combined with cash anticipated from sales of marketed products, to be enough to fund its operations in the foreseeable future.

APLS' Recent Pipeline Update

In September 2024, Apellis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency confirmed its June 2024 negative opinion on the regulatory filing for intravitreal pegcetacoplan to treat geographic atrophy secondary to age-related macular degeneration.

APLS also stated that the CHMP opinion was issued despite broad support for pegcetacoplan from the European retina community and several dissenting votes from CHMP members who had advocated for a path to approval.

In August 2024, Apellis and partner Sobi announced positive top-line data from the phase III VALIANT study evaluating systemic pegcetacoplan in C3 glomerulopathy (C3G) and primary immune complex glomerulonephritis (IC-MPGN) patients.

Per the data readout, the study achieved its primary endpoint, demonstrating a statistically significant and clinically meaningful 68% proteinuria reduction in C3G and IC-MPGN patients treated with pegcetacoplan versus placebo, both in addition to background therapy, at week 26.

Additionally, the study also achieved its key secondary endpoints with statistical significance, whereas nominal significance was observed on the histological endpoint. In the VALIANT study, pegcetacoplan was overall well-tolerated with a consistent safety profile.

Apellis is planning to submit a supplemental new drug application seeking approval for pegcetacoplan in C3G and IC-MPGN in early 2025. A similar regulatory filing by Sobi in the EU is also planned for early 2025.

Apellis Pharmaceuticals, Inc. Price, Consensus and EPS Surprise

Apellis Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Apellis Pharmaceuticals, Inc. Quote

APLS' Zacks Rank

Apellis currently carries a Zacks Rank #3 (Hold).

Key Biotech Picks

Some better-ranked stocks from this space are CRISPR Therapeutics AG CRSP, Atea Pharmaceuticals, Inc. AVIR and Amicus Therapeutics, Inc. FOLD, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 60 days, estimates for CRISPR Therapeutics’ 2024 loss per share have narrowed from $5.58 to $5.55. Loss per share estimates for 2025 have narrowed from $4.98 to $4.94 during the same time. Year to date, shares of CRSP have decreased 19.5%.

CRSP’s earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 101.83%.

In the past 60 days, estimates for Atea Pharmaceuticals’ 2024 loss per share have narrowed from $2.55 to $2.22. Loss per share estimates for 2025 have narrowed from $2.58 to $1.80 during the same time. Year to date, shares of AVIR have increased 9.8%.

AVIR’s earnings beat estimates in two of the trailing four quarters while missing on the remaining two occasions, the average surprise being 5.23%.

In the past 60 days, estimates for Amicus’ 2024 earnings per share have moved up from 21 cents to 22 cents. Earnings per share estimates for 2025 have improved from 50 cents to 53 cents during the same time. Year to date, shares of FOLD have declined 17.2%.

FOLD’s earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 23.96%.

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