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Apellis' (APLS) Q3 Earnings Miss Estimates, Revenues Top Mark
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Apellis Pharmaceuticals, Inc. (APLS - Free Report) reported a loss per share of $1.75 for third-quarter 2022, wider than the Zacks Consensus Estimate of a loss of $1.48. The loss was also wider than our estimate of a loss of $1.46 per share. The company reported a loss of $2.28 per share in the year-ago quarter.
Total revenues were $22.1 million, surpassing the Zacks Consensus Estimate of $20 million. Revenues in the reported quarter included sales of the marketed drug Empaveli (pegcetacoplan), which were $17.7 million and $4.4 million under the collaboration with Swedish Orphan Biovitrum (Sobi). In the year-ago quarter, the company reported revenues of $5.3 million.
Total revenues were higher than our estimate of $20.4 million in the reported quarter.
Shares of Apellis have risen 0.7% so far this year against the industry’s decline of 21.8%.
Image Source: Zacks Investment Research
In May 2021, the FDA approved Empaveli as a monotherapy treatment for adult patients suffering from PNH. PNH, a rare blood disorder, 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 (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 in July 2021, strengthening its immunology franchise.
Quarter in Detail
Research and development expenses were $95.2 million in the third quarter of 2022 compared with $87.7 million in the year-ago quarter. The increase can be primarily attributed to higher personnel-related costs, as well as innovation costs and device development expenses.
General and administrative expenses were $78.4 million in the third quarter of 2022 compared with $45.8 million in the year-ago quarter, driven by higher employee-related costs and an increase in professional and consulting fees.
As of Sep 30, 2022, Apellis had cash, cash equivalents and marketable securities worth $708.6 million compared with $852.8 million as of Jun 30, 2022.
Pipeline Update
Last week, APLS announced an update related to the new drug application (NDA) for its targeted C3 therapy, pegcetacoplan, for the treatment of geographic atrophy (“GA”) secondary to age-related macular degeneration (“AMD”).
The company plans to submit the 24-month efficacy data from the phase III DERBY and the phase III OAKS studies as part of its NDA application. This will be a major amendment to the NDA for pegcetacoplan as it will extend the review period by three months. A decision from the FDA is now expected in February 2023.
In July, the FDA accepted and granted priority review to the NDA for pegcetacoplan to treat GA secondary to AMD. A decision from the regulatory body was expected on Nov 26, 2022.
A marketing authorization application for pegcetacoplan to treat GA is expected to be filed in December 2022 with the European Medicines Agency.
Apellis is evaluating systemic pegcetacoplan in the phase II MERIDIAN study for treating amyotrophic lateral sclerosis. Top-line data from the same is expected in mid-2023.
Apellis and its Swedish partner Sobi dosed the first patient in the phase III VALIANT study evaluating pegcetacoplan for treating 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
Loss per share estimates for ASLAN Pharmaceuticals have narrowed 6.1% for 2022 and 5.7% for 2023 in the past 60 days.
Earnings of ASLAN Pharmaceuticals surpassed estimates in two of the trailing four quarters and missed the mark on the remaining two occasions. ASLN witnessed an earnings surprise of 1.64% on average.
Loss per share estimates for Amarin have narrowed 21% for 2022 and 50% for 2023 in the past 60 days.
Earnings of Amarin surpassed estimates in two of the trailing four quarters and missed the same on the other two occasions. AMRN witnessed a negative earnings surprise of 14.29% on average.
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Apellis' (APLS) Q3 Earnings Miss Estimates, Revenues Top Mark
Apellis Pharmaceuticals, Inc. (APLS - Free Report) reported a loss per share of $1.75 for third-quarter 2022, wider than the Zacks Consensus Estimate of a loss of $1.48. The loss was also wider than our estimate of a loss of $1.46 per share. The company reported a loss of $2.28 per share in the year-ago quarter.
Total revenues were $22.1 million, surpassing the Zacks Consensus Estimate of $20 million. Revenues in the reported quarter included sales of the marketed drug Empaveli (pegcetacoplan), which were $17.7 million and $4.4 million under the collaboration with Swedish Orphan Biovitrum (Sobi). In the year-ago quarter, the company reported revenues of $5.3 million.
Total revenues were higher than our estimate of $20.4 million in the reported quarter.
Shares of Apellis have risen 0.7% so far this year against the industry’s decline of 21.8%.
Image Source: Zacks Investment Research
In May 2021, the FDA approved Empaveli as a monotherapy treatment for adult patients suffering from PNH. PNH, a rare blood disorder, 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 (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 in July 2021, strengthening its immunology franchise.
Quarter in Detail
Research and development expenses were $95.2 million in the third quarter of 2022 compared with $87.7 million in the year-ago quarter. The increase can be primarily attributed to higher personnel-related costs, as well as innovation costs and device development expenses.
General and administrative expenses were $78.4 million in the third quarter of 2022 compared with $45.8 million in the year-ago quarter, driven by higher employee-related costs and an increase in professional and consulting fees.
As of Sep 30, 2022, Apellis had cash, cash equivalents and marketable securities worth $708.6 million compared with $852.8 million as of Jun 30, 2022.
Pipeline Update
Last week, APLS announced an update related to the new drug application (NDA) for its targeted C3 therapy, pegcetacoplan, for the treatment of geographic atrophy (“GA”) secondary to age-related macular degeneration (“AMD”).
The company plans to submit the 24-month efficacy data from the phase III DERBY and the phase III OAKS studies as part of its NDA application. This will be a major amendment to the NDA for pegcetacoplan as it will extend the review period by three months. A decision from the FDA is now expected in February 2023.
In July, the FDA accepted and granted priority review to the NDA for pegcetacoplan to treat GA secondary to AMD. A decision from the regulatory body was expected on Nov 26, 2022.
A marketing authorization application for pegcetacoplan to treat GA is expected to be filed in December 2022 with the European Medicines Agency.
Apellis is evaluating systemic pegcetacoplan in the phase II MERIDIAN study for treating amyotrophic lateral sclerosis. Top-line data from the same is expected in mid-2023.
Apellis and its Swedish partner Sobi dosed the first patient in the phase III VALIANT study evaluating pegcetacoplan for treating 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 & Stocks to Consider
Apellis currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the biotech sector are ASLAN Pharmaceuticals Limited (ASLN - Free Report) and Amarin Corporation plc (AMRN - 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.
Loss per share estimates for ASLAN Pharmaceuticals have narrowed 6.1% for 2022 and 5.7% for 2023 in the past 60 days.
Earnings of ASLAN Pharmaceuticals surpassed estimates in two of the trailing four quarters and missed the mark on the remaining two occasions. ASLN witnessed an earnings surprise of 1.64% on average.
Loss per share estimates for Amarin have narrowed 21% for 2022 and 50% for 2023 in the past 60 days.
Earnings of Amarin surpassed estimates in two of the trailing four quarters and missed the same on the other two occasions. AMRN witnessed a negative earnings surprise of 14.29% on average.