Apellis Pharmaceuticals, Inc.


APLS

delivered earnings of 93 cents per share in the fourth quarter of 2020 against the year-ago quarter’s loss of $1.77. The Zacks Consensus Estimate was pegged at a loss of 48 cents per share.

With no approved drug in its portfolio, the company does not generate revenues from the sale of products. However, in the fourth quarter, Apellis recorded licensing revenues of $250 million owing to the upfront proceeds from the Sobi transaction. In the year-ago quarter, the company did not record any revenue. Meanwhile, the top line beat the Zacks Consensus Estimate of $185 million.

Shares of Apellis have declined 21.3% in the year so far against the

industry’s

increase of 5.9%.

Quarter in Detail

Research and development (R&D) expenses were $75.4 million in the fourth quarter of 2020 compared with $78.5 million for the same period in 2019.

General and administrative expenses were $44.5 million in the fourth quarter of 2020 compared with $27.5 million reported in the year-ago quarter.

Apellis ended the fourth quarter of 2020 with cash, cash equivalents and marketable securities of $877.6 million, higher than $728.2 million at the end of the third quarter.

Full-Year Results

For 2020, Apellis generated licensing revenues of $250.6 million.

For the same period, the company reported loss of $4.59 per share compared with the year-ago loss of $4.90 per share.

Pipeline Update

Apellis’ lead pipeline candidate, pegcetacoplan, is being developed for subcutaneous administration in several indications.

The company has submitted a new drug application (“NDA”) for pegcetacoplan to the FDA for the treatment of paroxysmal nocturnal hemoglobinuria (“PNH”). With the FDA granting a priority review to the NDA, a decision from the regulatory body is expected on May 14, 2021. A potential approval will be a boost for the company as it can generate revenues from the sale of the drug in future quarters.

The company has also file marketing authorization application (MAA) to the European Medicines Agency for pegcetacoplan for treating PNH with a decision from the European Commission expected in the second half of 2021. Both the NDA and the MAA fillings for pegcetacoplan were based on results from the PEGASUS study.

Please note that, in December 2020, the company reported additional data from the phase III PEGASUS study, which evaluated pegcetacoplan for PNH as compared to

Alexion

’s

ALXN

blockbuster drug, Soliris (eculizumab). Data from the same showed that treatment with pegcetacoplan led to statistically significant improvements in overall treatment response and substantial quality-of-life improvements versus Soliris at 16 weeks.

Meanwhile, pegcetacoplan is also being evaluated in the phase III PRINCE study in treatment-naive PNH patients. Top-line data from the same is expected in the second quarter of 2021. The candidate is also being evaluated in two phase III studies, namely, DERBY and OAKS for treating in patients with geographic atrophy. Top-line results from both studies are expected in the third quarter of 2021.

Zacks Rank Stocks to Consider

Apellis currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include

Lexicon Pharmaceuticals, Inc.


LXRX

and

Nabriva


Therapeutics AG


NBRV

, 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


.

Lexicon’s loss per share estimates have narrowed 74.2% for 2021 over the past 60 days. The stock has skyrocketed 118.7% year to date.

Nabriva’sloss per share estimates have narrowed 8.9% for 2021 over the past 60 days.

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