Apellis Pharmaceuticals, Inc. APLS reported a fourth-quarter 2021 loss per share of $1.61, wider than the Zacks Consensus Estimate of a loss of $1.32. The company reported earnings of 93 cents per share in the year-ago quarter.
Total revenues were $60 million, which comprehensively beat the Zacks Consensus Estimate of $9 million. Revenues in the reported quarter comprised sales of marketed drug Empaveli (pegcetacoplan), which were $9.2 million, and $51.1 million under the collaboration with Swedish Orphan Biovitrum (Sobi). In the year-ago quarter, the company recorded $250 million as licensing revenues.
In May 2021, the FDA approved Empaveli as a monotherapy treatment for adult patients suffering from PNH. A rare blood disorder, PNH is associated with abnormally low hemoglobin levels as the disease destroys red blood cells.
Empaveli is approved for treatment-naïve patients and those switching from Alexion’s [now part of AstraZeneca’s AZN] C5 inhibitor therapies for PNH, namely Soliris and Ultomiris (ravulizumab).
In July 2021, AstraZeneca closed the acquisition of rare disease drugmaker, Alexion, for $39 billion.
Shares of Apellis have lost 6.7% in the past year compared with the industry’s plunge of 36.5%.
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For 2021, Apellis generated total revenues of $66.6 million compared with $250.6 million recorded in 2020.
For the year, the company reported a loss of $8.84 per share compared with a net loss of $4.59 per share in 2020.
Quarter in Detail
Research and development expenses were $108.2 million in the fourth quarter of 2021 compared with $75.4 million for the same period in 2020.
General and administrative expenses were $41.5 million in the fourth quarter of 2021 compared with $44.5 million reported in the year-ago quarter.
Apellis ended the fourth quarter with cash, cash equivalents and marketable securities of $700.6 million compared with $430.3 million at the end of the third quarter of 2021.
In December 2021, the European Commission approved Aspaveli for the treatment of adult patients with PNH who are anemic after treatment with a C5 inhibitor for at least three months. The drug is marketed under the trade name Empaveli in the United States.
Apart from PNH, Apellis is developing pegcetacoplan with Sobi for other rare diseases.
Pegcetacoplan is being evaluated in two phase III studies, namely, DERBY and OAKS, for treating patients with geographic atrophy or GA. Apellis is planning to submit a new drug application or NDA to the FDA for intravitreal pegcetacoplan to treat GA in the second quarter of 2022.
The company is looking to submit a marketing authorization application to the European Medicines Agency for pegcetacoplan to treat GA in the second half of 2022.
The phase II MERIDIAN study is evaluating systemic pegcetacoplan for treating amyotrophic lateral sclerosis or ALS. The company plans to complete enrollment in the study in the first half of 2022. A potential label expansion of the drug for any of the above indications will be a boost to the company’s top line.
Apellis plans to initiate a phase III study evaluating systemic pegcetacoplan for the treatment of immune complex membranoproliferative glomerulonephritis/C3 glomerulopathy in the first half of 2022.
Meanwhile, Sobi plans to begin a phase III study evaluating systemic pegcetacoplan to treat cold agglutinin disease in the first half of 2022. Earlier this year, Sobi enrolled the first patient in a phase II study evaluating the safety and efficacy of systemic pegcetacoplan to treat patients with hematopoietic stem cell transplantation-associated thrombotic microangiopathy.
Apellis Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Apellis Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Apellis Pharmaceuticals, Inc. Quote
Zacks Rank & Stocks to Consider
Apellis currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Dynavax Technologies Corporation DVAX and Kaleido Biosciences, Inc. KLDO, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Dynavax’s earnings estimates have been revised 10.3% upward for 2022 over the past 60 days. The stock has rallied 42.1% in the past year.
Earnings of Dynavax have surpassed estimates in each of the trailing four quarters.
Kaleido Biosciences’ loss per share estimates have narrowed 11.3% for 2022 over the past 60 days.
Earnings of Kaleido Biosciences have surpassed estimates in three of the trailing four quarters and missed the same once.
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