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Amicus Therapeutics (FOLD - Free Report) reported a loss of 19 cents per share in fourth-quarter 2022, wider than the Zacks Consensus Estimate of a loss of 13 cents. The company reported an adjusted loss of 29 cents per share in the year-ago quarter.
Revenues in the fourth quarter were $88.1 million, up 7% year over year, beating the Zacks Consensus Estimate of $87 million. Revenues were generated from the sales of Galafold (migalastat), approved for Fabry disease. On a constant-currency (cc) basis, total year-over-year revenue growth was 16%.
Shares of Amicus have surged 63% in the past year against the industry’s 10.9% decline.
Image Source: Zacks Investment Research
2022 Results
Revenues in 2022 were $329.2 million, up 8% from 2021, driven by strong patient demand. On a CC basis, total revenue growth was 16%. Reported revenues were offset by a negative currency impact of 8%.
Further, 65% of revenues came from outside the country and the remaining 35% from the United States.
Operating expenses (adjusted basis) were $413.2 million, up from $406.9 million in the year-ago quarter.
As of Dec 31, 2022, Amicus had cash, cash equivalents and marketable securities of $293.6 million compared with $354.7 million as of Sep 30, 2022.
2023 Guidance
For 2023, Amicus expects total Galafold revenue growth between 12% and 17% at CC, driven by continued underlying demand from both switch and treatment-naïve patients, geographic expansion, label extensions, the continued diagnosis of new Fabry patients, and commercial execution across all major markets, including the United States, EU, the U.K. and Japan.
Adjusted operating expenses are estimated between $340-$360 million.
Other Updates
The lead pipeline candidate in Amicus’ portfolio is AT-GAA, developed as a potential treatment for Pompe disease. The FDA had previously extended the target action dates to Aug 29, 2022, for the new drug application (NDA) and Oct 29, 2022, for the biologics license application (BLA), reflecting the two components of AT-GAA.
On Oct 28, 2022, Amicus reported that the FDA had deferred action on the BLA for cipaglucosidase alfa, the biologic component of AT-GAA, since the regulatory body was unable to conduct the required inspection of the WuXi Biologics manufacturing site in China during the review cycle due to COVID-19-related travel restrictions. Thus, the FDA has deferred action on the application until the inspection of the manufacturing site is complete. Amicus expects the FDA to approve the two components of AT-GAA, including the BLA and the NDA for miglustat, together.
On the call, management stated that the FDA scheduled the required pre-approval inspection of the WuXi Biologics manufacturing site in China in the second quarter of this year.
Management expects regulatory approval and the launch of AT-GAA in the United States in the third quarter of 2023, pending the completion of a successful inspection. In December 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the marketing authorization of cipaglucosidase alfa, a long-term enzyme replacement therapy (ERT) used in combination with miglustat for adults with late-onset Pompe disease.
AMRN’s loss estimates narrowed by 2 cents for 2023 and by 5 cents for 2024 in the past 60 days. Amarin surpassed earnings in two of the trailing four quarters and missed in the remaining two, the average negative earnings surprise being 14.29%.
GERN’s loss estimates for 2022 have been flat too but have narrowed by 2 cents for 2023 in the past 60 days. Geron surpassed earnings in two of the trailing four quarters and missed in the remaining two, the average earnings surprise being 1.07%.
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Amicus (FOLD) Q4 Earnings Miss, Galafold Sales Beat Estimates
Amicus Therapeutics (FOLD - Free Report) reported a loss of 19 cents per share in fourth-quarter 2022, wider than the Zacks Consensus Estimate of a loss of 13 cents. The company reported an adjusted loss of 29 cents per share in the year-ago quarter.
Revenues in the fourth quarter were $88.1 million, up 7% year over year, beating the Zacks Consensus Estimate of $87 million. Revenues were generated from the sales of Galafold (migalastat), approved for Fabry disease. On a constant-currency (cc) basis, total year-over-year revenue growth was 16%.
Shares of Amicus have surged 63% in the past year against the industry’s 10.9% decline.
Image Source: Zacks Investment Research
2022 Results
Revenues in 2022 were $329.2 million, up 8% from 2021, driven by strong patient demand. On a CC basis, total revenue growth was 16%. Reported revenues were offset by a negative currency impact of 8%.
Further, 65% of revenues came from outside the country and the remaining 35% from the United States.
Operating expenses (adjusted basis) were $413.2 million, up from $406.9 million in the year-ago quarter.
As of Dec 31, 2022, Amicus had cash, cash equivalents and marketable securities of $293.6 million compared with $354.7 million as of Sep 30, 2022.
2023 Guidance
For 2023, Amicus expects total Galafold revenue growth between 12% and 17% at CC, driven by continued underlying demand from both switch and treatment-naïve patients, geographic expansion, label extensions, the continued diagnosis of new Fabry patients, and commercial execution across all major markets, including the United States, EU, the U.K. and Japan.
Adjusted operating expenses are estimated between $340-$360 million.
Other Updates
The lead pipeline candidate in Amicus’ portfolio is AT-GAA, developed as a potential treatment for Pompe disease. The FDA had previously extended the target action dates to Aug 29, 2022, for the new drug application (NDA) and Oct 29, 2022, for the biologics license application (BLA), reflecting the two components of AT-GAA.
On Oct 28, 2022, Amicus reported that the FDA had deferred action on the BLA for cipaglucosidase alfa, the biologic component of AT-GAA, since the regulatory body was unable to conduct the required inspection of the WuXi Biologics manufacturing site in China during the review cycle due to COVID-19-related travel restrictions. Thus, the FDA has deferred action on the application until the inspection of the manufacturing site is complete. Amicus expects the FDA to approve the two components of AT-GAA, including the BLA and the NDA for miglustat, together.
On the call, management stated that the FDA scheduled the required pre-approval inspection of the WuXi Biologics manufacturing site in China in the second quarter of this year.
Management expects regulatory approval and the launch of AT-GAA in the United States in the third quarter of 2023, pending the completion of a successful inspection. In December 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the marketing authorization of cipaglucosidase alfa, a long-term enzyme replacement therapy (ERT) used in combination with miglustat for adults with late-onset Pompe disease.
Zacks Rank & Stocks to Consider
Amicus currently carries a Zacks Rank #4 (Sell).
A couple of better-ranked stocks in the sector are Amarin (AMRN - Free Report) and Geron (GERN - Free Report) , both currently carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
AMRN’s loss estimates narrowed by 2 cents for 2023 and by 5 cents for 2024 in the past 60 days. Amarin surpassed earnings in two of the trailing four quarters and missed in the remaining two, the average negative earnings surprise being 14.29%.
GERN’s loss estimates for 2022 have been flat too but have narrowed by 2 cents for 2023 in the past 60 days. Geron surpassed earnings in two of the trailing four quarters and missed in the remaining two, the average earnings surprise being 1.07%.