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Apellis' (APLS) Earnings Top, Empaveli Sales Boost Revenues

Apellis Pharmaceuticals, Inc. APLS reported a loss per share of $1.50 for fourth-quarter 2022, narrower than the Zacks Consensus Estimate of a loss of $1.65. The loss was also narrower than our estimate of a loss of $1.82 per share. The company reported a loss of $1.61 per share in the year-ago quarter.

Total revenues were $22.7 million, surpassing the Zacks Consensus Estimate of $21 million. Total revenues were also higher than our estimate of $21.2 million in the reported quarter. In the year-ago quarter, the company reported revenues of $60.3 million. The drastic difference is due to the $51.1 million milestone and additional licensing revenues received from the Swedish Orphan Biovitrum (Sobi) collaboration in the year-ago quarter.

Revenues in the reported quarter included product sales of the marketed drug Empaveli (pegcetacoplan), which were $19.7 million and licensing and other revenues of $3 million under the collaboration with Sobi.

Shares of Apellis have risen 39.9% so far this year against the industry’s decline of 6.9%.

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Zacks Investment Research

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Empaveli was approved by the FDA in May 2021 as a monotherapy treatment for adult patients suffering from Paroxysmal Nocturnal Hemoglobinuria (PNH), a rare blood disorder.

Empaveli was approved for treatment-naïve patients and those switching from Alexion’s [now part of AstraZeneca AZN] C5 inhibitor therapies for PNH, namely Soliris and Ultomiris (ravulizumab).

AZN closed the acquisition of rare-disease drugmaker Alexion for $39 billion in July 2021, strengthening its immunology franchise.

Quarter in Detail

Research and development expenses were down 8.13% to $99.4 million in the fourth quarter of 2022 compared with $108.2 million in the year-ago quarter.

General and administrative expenses were up 103.4% to $84.4 million in the fourth quarter of 2022 compared with $41.5 million in the year-ago quarter, driven by higher employee-related costs and an increase in professional and consulting fees.

As of Dec 31, 2022, Apellis had cash, cash equivalents and marketable securities worth $551.8 million compared with $708.6 million as of Sep 30, 2022.

Full-Year 2022 Results

For the full-year 2022, Apellis generated total revenues of $75.4 million, representing a year-over-year growth of 13.2%.

The company recorded a loss per share of $6.15 for the full year 2022, narrower than the loss per share of $8.84 in the previous year.

Pipeline Updates

On Feb 17, 2023, Apellis announced that the FDA has approved pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration. The drug is to be marketed under the brand name Syfovre. The commercial launch of the drug is expected by the beginning of March 2023.

A marketing authorization application seeking approval of pegcetacoplan for geographic atrophy is currently under review by the European Medicines Agency. A decision regarding the same is expected in early 2024.

In February 2023, the FDA approved the supplemental new drug application (sNDA), seeking approval of Empaveli for treatment-naive PNH patients. The approval was based on results from the phase III PRINCE and the 48-week phase III PEGASUS studies.

Apellis’ Empaveli Injector sNDA is also currently under review. Empaveli injector is an on-body drug delivery system capable of self-administering pegcetacoplan through subcutaneous infusion.

Apellis expects to report top-line results from its ongoing phase II MERIDIA study of systemic pegcetacoplan for amyotrophic lateral sclerosis in mid-2023.

The phase III VALIANT study of systemic pegcetacoplan for Immune complex membranoproliferative glomerulonephritis and C3 glomerulopathy is currently enrolling patients.

Apeelis’ partner, Sobi, is currently enrolling patients in its phase II study evaluating the efficacy and safety of systemic pegcetacoplan in patients with hematopoietic stem cell transplantation-associated thrombotic microangiopathy. Data from this study is expected in the second half of 2023. Additionally, Sobi is also currently enrolling patients for its phase III CASCADE study of systemic pegcetacoplan for cold agglutinin disease.

Zacks Rank and Stocks to Consider

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

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Some top-ranked stocks in the medical industry are Catalyst Pharmaceuticals CPRX and Collegium Pharmaceutical COLL, both sporting a Zacks Rank of 1.

Estimates for Catalyst’s 2023 earnings per share have improved from $1.10 per share to $1.13 in the past 60 days.

Earnings of Catalyst missed estimates in two of the trailing four quarters and beat the same twice. The average negative earnings surprise for CPRX is 4.10%. CPRX stock has risen 105.3% in the past year. Catalyst is expected to report its fourth-quarter results next month.

Estimates for Collegium Pharmaceutical’s 2023 earnings have risen from $5.84 to $6.20 per share in the past 60 days.

Collegium Pharmaceutical missed earnings estimates in each of the last four quarters, the average negative surprise being 77.06%. COLL’s stock has risen 15.3% in the past year.

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