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Apellis (APLS) Q2 Earnings and Sales Miss Estimates, Stock Down
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Apellis Pharmaceuticals, Inc. (APLS - Free Report) reported a loss per share of $1.46 in second-quarter 2022, wider than the Zacks Consensus Estimate of a loss of $1.43. The company reported a loss of $2.72 per share in the year-ago quarter.
Total revenues were $16.3 million, missing the Zacks Consensus Estimate of $17 million. Revenues in the reported quarter included sales of marketed drug Empaveli (pegcetacoplan), which were $15.7 million, and $0.6 million under the collaboration with Swedish Orphan Biovitrum (Sobi). In the year-ago quarter, the company reported revenues of $1.0 million.
Shares of Apellis were down 3.7% after market hours, on Aug 8, probably due to the earnings results. In the year so far, the stock has returned 31.9% compared with the industry’s decrease of 17.3%.
Image Source: Zacks Investment Research
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 for those switching from Alexion’s [now part of AstraZeneca (AZN - Free Report) C5 inhibitor therapies for PNH, namely Soliris and Ultomiris (ravulizumab).
AZN closed the acquisition of rare-disease drugmaker, Alexion, for $39 billion last July, strengthening the former’s immunology franchise.
Quarter in Detail
Research and development expenses were $101.7 million in the second quarter of 2022 compared with $145.9 million in the year-ago quarter. The decline can be primarily attributed to decreased cost of manufacturing expenses and the $50 million cost of research collaboration with Beam Therapeutics (BEAM - Free Report) .
The company entered into an exclusive five-year research collaboration with Beam in June 2021 to work on six research programs focused on C3 and other complement targets in the eye, liver and brain. Per the management, the company has made progress with the Beam partnership, advancing complement inhibition as a novel approach, enhancing adeno-associated virus (AAV) -based gene therapy products.
General and administrative expenses were $63.2 million in the second quarter of 2022 compared with $49 million in the year-ago quarter, driven by employee-related expenses and general commercialization activities.
As of Jun 30, 2022, Apellis had cash, cash equivalents and marketable securities worth $852.8 million compared with $965.3 million as of Mar 31, 2022.
Pipeline Update
Apellis submitted a new drug application (NDA) to the FDA seeking approval for its targeted C3 therapy, pegcetacoplan, for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in June. In July, FDA accepted and granted priority review to its NDA for pegcetacoplan for the aforementioned indication. A decision from the regulatory body is expected on Nov 26, 2022.
A marketing authorization application for pegcetacoplan to treat GA is expected to be filed in the second half of 2022 to the European Medicines Agency.
Apellis and its Swedish partner Sobi dosed the first patient in phase III VALIANT study evaluating pegcetacoplan to treat primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) and C3 glomerulopathy (C3G) — two rare and debilitating kidney diseases.
Apellis Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Novavax’s earnings estimates for 2022 have remained steady at $27.23 over the past 30 days. Shares of NVAX have declined 59.9% year to date. Earnings of Novavax missed estimates in all of the last four quarters. NVAX reported a negative earnings surprise of 184.49%, on average.
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Apellis (APLS) Q2 Earnings and Sales Miss Estimates, Stock Down
Apellis Pharmaceuticals, Inc. (APLS - Free Report) reported a loss per share of $1.46 in second-quarter 2022, wider than the Zacks Consensus Estimate of a loss of $1.43. The company reported a loss of $2.72 per share in the year-ago quarter.
Total revenues were $16.3 million, missing the Zacks Consensus Estimate of $17 million. Revenues in the reported quarter included sales of marketed drug Empaveli (pegcetacoplan), which were $15.7 million, and $0.6 million under the collaboration with Swedish Orphan Biovitrum (Sobi). In the year-ago quarter, the company reported revenues of $1.0 million.
Shares of Apellis were down 3.7% after market hours, on Aug 8, probably due to the earnings results. In the year so far, the stock has returned 31.9% compared with the industry’s decrease of 17.3%.
Image Source: Zacks Investment Research
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 for those switching from Alexion’s [now part of AstraZeneca (AZN - Free Report) C5 inhibitor therapies for PNH, namely Soliris and Ultomiris (ravulizumab).
AZN closed the acquisition of rare-disease drugmaker, Alexion, for $39 billion last July, strengthening the former’s immunology franchise.
Quarter in Detail
Research and development expenses were $101.7 million in the second quarter of 2022 compared with $145.9 million in the year-ago quarter. The decline can be primarily attributed to decreased cost of manufacturing expenses and the $50 million cost of research collaboration with Beam Therapeutics (BEAM - Free Report) .
The company entered into an exclusive five-year research collaboration with Beam in June 2021 to work on six research programs focused on C3 and other complement targets in the eye, liver and brain. Per the management, the company has made progress with the Beam partnership, advancing complement inhibition as a novel approach, enhancing adeno-associated virus (AAV) -based gene therapy products.
General and administrative expenses were $63.2 million in the second quarter of 2022 compared with $49 million in the year-ago quarter, driven by employee-related expenses and general commercialization activities.
As of Jun 30, 2022, Apellis had cash, cash equivalents and marketable securities worth $852.8 million compared with $965.3 million as of Mar 31, 2022.
Pipeline Update
Apellis submitted a new drug application (NDA) to the FDA seeking approval for its targeted C3 therapy, pegcetacoplan, for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in June. In July, FDA accepted and granted priority review to its NDA for pegcetacoplan for the aforementioned indication. A decision from the regulatory body is expected on Nov 26, 2022.
A marketing authorization application for pegcetacoplan to treat GA is expected to be filed in the second half of 2022 to the European Medicines Agency.
Apellis and its Swedish partner Sobi dosed the first patient in phase III VALIANT study evaluating pegcetacoplan to treat primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) and C3 glomerulopathy (C3G) — two rare and debilitating kidney diseases.
Apellis Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Apellis Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Apellis Pharmaceuticals, Inc. Quote
Zacks Rank & A Stock to Consider
Apellis currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the same sector is Novavax (NVAX - Free Report) , carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Novavax’s earnings estimates for 2022 have remained steady at $27.23 over the past 30 days. Shares of NVAX have declined 59.9% year to date. Earnings of Novavax missed estimates in all of the last four quarters. NVAX reported a negative earnings surprise of 184.49%, on average.