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Apellis' (APLS) Q2 Earnings & Revenues Fall Shy of Estimates
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Apellis Pharmaceuticals, Inc. (APLS - Free Report) reported second-quarter 2021 loss per share of $2.72, wider than the Zacks Consensus Estimate of a loss of $1.70. The company had reported a loss of $1.57 per share in the year-ago quarter.
Total revenues of $0.6 million comprising solely Empaveli (pegcetacoplan) sales also missed the Zacks Consensus Estimate of $2 million. In the year-ago quarter, the company did not record any revenues.
In May 2021, the FDA approved Apellis’ targeted C3 therapy Empaveli as a monotherapy treatment for adult patients suffering paroxysmal nocturnal hemoglobinuria (PNH). This marked the first FDA nod to the company for any of its products. 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 (AZN - Free Report) ] C5 inhibitor therapies for PNH, namely Soliris (eculizumab) and Ultomiris (ravulizumab).
Shares of Apellis have rallied 8.4% in the year so far compared with the industry’s increase of 1.8%.
Image Source: Zacks Investment Research
Quarter in Detail
Research and development (R&D) expenses were $145.9 million in the second quarter of 2021 compared with $87.1million for the same period in 2020. This increase was primarily due to cost under the Beam collaboration.
General and administrative expenses were $49 million in the second quarter of 2021 compared with $28.4million 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 second quarter with cash, cash equivalents and marketable securities of $599 million, lower than $723.7 million at the end of the first quarter of 2021.
Pipeline Update
We remind investors that a marketing authorization application seeking an approval for Empaveli as a treatment of PNH patients is under review in Europe. A potential approval is anticipated in the second half of 2021.
Apart from PNH, Apellis is developing Empaveli for systemic administration for several indications. Empaveli is being evaluated as a monotherapy in two phase III studies, namely DERBY and OAKS for treating patients with geographic atrophy. Top-line data from the same is due next month.
The company also plans to initiate a potentially registrational study on Empaveli for intermediate dry age-related macular degeneration next year if the DERBY and OAKS studies meet their primary efficacy endpoints in the monthly arm.
In May 2021, Apellis and partner Swedish Orphan Biovitrum (Sobi) announced top-line data from the phase III PRINCE study, which showed that treatment with Empaveli led to a statistical superiority on the co-primary endpoints of hemoglobin stabilization and reduction in lactate dehydrogenase as compared to the standard of care at week 26 of treatment.
Empaveli is also being investigated in the phase II MERIDIAN study for treating amyotrophic lateral sclerosis (ALS). The company plans to complete enrollment in this study by 2021 end.
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 (CAD) and a potentially registrational program to treat hematopoietic stem cell transplantation-associated thrombotic microangiopathy (HSCT-TMA).
Apellis Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Image: Bigstock
Apellis' (APLS) Q2 Earnings & Revenues Fall Shy of Estimates
Apellis Pharmaceuticals, Inc. (APLS - Free Report) reported second-quarter 2021 loss per share of $2.72, wider than the Zacks Consensus Estimate of a loss of $1.70. The company had reported a loss of $1.57 per share in the year-ago quarter.
Total revenues of $0.6 million comprising solely Empaveli (pegcetacoplan) sales also missed the Zacks Consensus Estimate of $2 million. In the year-ago quarter, the company did not record any revenues.
In May 2021, the FDA approved Apellis’ targeted C3 therapy Empaveli as a monotherapy treatment for adult patients suffering paroxysmal nocturnal hemoglobinuria (PNH). This marked the first FDA nod to the company for any of its products. 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 (AZN - Free Report) ] C5 inhibitor therapies for PNH, namely Soliris (eculizumab) and Ultomiris (ravulizumab).
Shares of Apellis have rallied 8.4% in the year so far compared with the industry’s increase of 1.8%.
Image Source: Zacks Investment Research
Quarter in Detail
Research and development (R&D) expenses were $145.9 million in the second quarter of 2021 compared with $87.1million for the same period in 2020. This increase was primarily due to cost under the Beam collaboration.
General and administrative expenses were $49 million in the second quarter of 2021 compared with $28.4million 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 second quarter with cash, cash equivalents and marketable securities of $599 million, lower than $723.7 million at the end of the first quarter of 2021.
Pipeline Update
We remind investors that a marketing authorization application seeking an approval for Empaveli as a treatment of PNH patients is under review in Europe. A potential approval is anticipated in the second half of 2021.
Apart from PNH, Apellis is developing Empaveli for systemic administration for several indications. Empaveli is being evaluated as a monotherapy in two phase III studies, namely DERBY and OAKS for treating patients with geographic atrophy. Top-line data from the same is due next month.
The company also plans to initiate a potentially registrational study on Empaveli for intermediate dry age-related macular degeneration next year if the DERBY and OAKS studies meet their primary efficacy endpoints in the monthly arm.
In May 2021, Apellis and partner Swedish Orphan Biovitrum (Sobi) announced top-line data from the phase III PRINCE study, which showed that treatment with Empaveli led to a statistical superiority on the co-primary endpoints of hemoglobin stabilization and reduction in lactate dehydrogenase as compared to the standard of care at week 26 of treatment.
Empaveli is also being investigated in the phase II MERIDIAN study for treating amyotrophic lateral sclerosis (ALS). The company plans to complete enrollment in this study by 2021 end.
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 (CAD) and a potentially registrational program to treat hematopoietic stem cell transplantation-associated thrombotic microangiopathy (HSCT-TMA).
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 #4 (Sell).
Better-ranked stocks in the biotech sector include Repligen Corporation (RGEN - Free Report) and Spero Therapeutics, Inc. (SPRO - 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.
Repligen’s earnings estimates have been revised 19% upward for 2021 and 14.8% for 2022 over the past 60 days. The stock has surged 33.3% year to date.
Spero Therapeutics’ loss per share estimates have narrowed 1% for 2021 and 2% for 2022 over the past 60 days.