Apellis Pharmaceuticals, Inc. ( APLS Quick Quote APLS - Free Report) reported third-quarter 2021 loss per share of $2.28, wider than the Zacks Consensus Estimate of a loss of $1.73. The company had reported a loss of $1.79 per share in the year-ago quarter.
Total revenues came in at $5.7 million, which beat the Zacks Consensus Estimate of $2 million. Revenues in the reported quarter comprised sales of marketed drug Empaveli (pegcetacoplan), which were $5.3 million, and $0.4 million under the collaboration with Swedish Orphan Biovitrum (Sobi). In the year-ago quarter, the company recorded $0.6 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 as well as those switching from Alexion’s [now part of
AstraZeneca’s ( AZN Quick Quote AZN - Free Report) ] C5 inhibitor therapies for PNH, namely Soliris and Ultomiris (ravulizumab).
Shares of Apellis have plunged 41.1% in the year so far compared with the
industry’s decrease of 12.5%. Image Source: Zacks Investment Research Quarter in Detail
Research and development (R&D) expenses were $87.7 million in the third quarter of 2021 compared with $93.2 million for the same period in 2020, owing to decrease in contract manufacturing expenses.
General and administrative expenses were $45.8 million in the third quarter of 2021 compared with $37 million reported in the year-ago quarter. The rise was due to high cost of commercial activities and high employee-related other costs.
Apellis ended the third quarter with cash, cash equivalents and marketable securities of $430.3 million, lower than $599 million at the end of the second quarter of 2021.
In October 2021, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use or CHMP rendered a positive opinion on, and has recommended marketing authorization to Aspaveli (pegcetacoplan) for the treatment of PNH in adult patients who are anemic following treatment with a C5 inhibitor for at least three months. The opinion will now be reviewed by the European Commission, with a decision expected by 2021-end.
Apart from PNH, Apellis is developing Empaveli with Sobi for systemic administration in several indications.
Pegcetacoplan, as a monotherapy, is being evaluated in two phase III studies, namely, DERBY and OAKS, for treating patients with geographic atrophy. In September 2021, Apellis
announced mixed top-line data from the DERBY and OAKS studies. While the OAKS study met the primary endpoint, the DERBY study did not.
Pegcetacoplan was well tolerated across both studies and demonstrated a favorable safety profile. The company plans to submit a new drug application to the FDA for pegcetacoplan to treat GA in the first half of 2022.
Pegcetacoplan is also being investigated in the phase II MERIDIAN study for treating amyotrophic lateral sclerosis or ALS. The company plans to complete enrollment in this 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 phase III studies for the treatment of immune complex membranoproliferative glomerulonephritis (IC-MPGN) and C3 glomerulopathy (C3G). Concurrently, Sobi plans to begin a phase III study to address cold agglutinin disease and a potentially registrational program to treat hematopoietic stem cell transplantation-associated thrombotic microangiopathy (HSCT-TMA). All these studies are expected to begin later in the fourth quarter of 2021.
Zacks Rank & Stocks to Consider
Apellis currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include
Amicus Therapeutics, Inc. ( FOLD Quick Quote FOLD - Free Report) and Agenus Inc. ( AGEN Quick Quote AGEN - Free Report) , 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
Amicus Therapeutics’ loss per share estimates have narrowed 1.3% for 2021 and 37.5% for 2022 over the past 60 days.
Agenus’ loss per share estimates have narrowed 17.8% for 2021 and 20.6% for 2022 over the past 60 days. The stock has rallied 31.4% year to date.