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Amicus (FOLD) Q3 Earnings Beat, Galafold Sales Miss Estimates
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Amicus Therapeutics (FOLD - Free Report) reported a loss of 12 cents per share in third-quarter 2022, narrower than the Zacks Consensus Estimate of a loss of 19 cents. The company reported an adjusted loss of 19 cents per share in the year-ago quarter.
Revenues increased 2.7% year over year to $81.7 million in the third quarter, missing the Zacks Consensus Estimate of $85 million. Revenues were generated0 from the sales of Galafold (migalastat), approved for Fabry disease. On a constant-currency (cc) basis, total revenue growth was 14% year over year.
Shares of Amicus Therapeutics have slumped 10.6% in the year compared with the industry’s 20.3% decline.
Image Source: Zacks Investment Research
Quarter in Detail
Revenues in the third quarter were driven by strong new patient accruals but were partially offset by order timing in certain ex-US markets and foreign currency impact.
Operating expenses (adjusted basis) were $85.5 million, down 8.7% year over year.
As of Sep 30, 2022, Amicus Therapeutics had cash, cash equivalents and marketable securities of $354.7 million compared with $368.8 million on Jun 30, 2022.
Maintains 2022 Guidance
For the full year, Amicus Therapeutics expects total Galafold revenue growth between 15% and 20% at CER driven by continued underlying demand from geographic expansion, continued diagnosis of new Fabry patients and commercial execution across all major markets, including the United States, European Union, United Kingdom and Japan.
Adjusted operating expenses for the year have been updated and are presently estimated between $430-$440 million, down from the previous estimate of $470-$485 million. The downside can be attributed to prudent expense management and offset by continued investments for the global Galafold launch, AT-GAA clinical studies and pre-launch activities
Other Updates
The lead pipeline candidate in Amicus Therapeutics’ 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 Biologic License Application (BLA), reflective of 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-elated 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.
In the EU, Amicus Therapeutics completed the marketing authorization application (MAA) submissions for AT-GAA in fourth-quarter 2021. A positive opinion on the MAA by the EMA’s Committee for Medicinal Products for Human Use (CHMP) is expected in December this year
Amicus Therapeutics, Inc. Price, Consensus and EPS Surprise
Puma Biotechnology’s loss estimates for 2022 have remained steady at 6 cents over the past 30 days. Shares of PBYI have returned 29.5% year to date. Earnings of Puma beat earnings estimates in three of the trailing four quarters and missed the same in the remaining occasion. PBYI delivered an earnings surprise of 201.37%, on average.
Kodiak Sciences’ loss estimates for 2022 have remained steady at $7.12 over the past 30 days. Shares of Kodiak have declined 91.8% year to date. Earnings of KOD beat earnings estimates only once in the last four quarters. KOD delivered a negative earnings surprise of 20.20%, on average
AVEO Pharmaceuticals’ loss estimates for 2022 have improved from 94 cents to 76 cents in the past 30 days. Shares of Aveo have returned 214.1% year to date. Earnings of AVEO beat earnings estimates in three of the trailing four quarters, while missing the same in one. AVEO delivered a positive earnings surprise of 13.10%, on average.
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Amicus (FOLD) Q3 Earnings Beat, Galafold Sales Miss Estimates
Amicus Therapeutics (FOLD - Free Report) reported a loss of 12 cents per share in third-quarter 2022, narrower than the Zacks Consensus Estimate of a loss of 19 cents. The company reported an adjusted loss of 19 cents per share in the year-ago quarter.
Revenues increased 2.7% year over year to $81.7 million in the third quarter, missing the Zacks Consensus Estimate of $85 million. Revenues were generated0 from the sales of Galafold (migalastat), approved for Fabry disease. On a constant-currency (cc) basis, total revenue growth was 14% year over year.
Shares of Amicus Therapeutics have slumped 10.6% in the year compared with the industry’s 20.3% decline.
Image Source: Zacks Investment Research
Quarter in Detail
Revenues in the third quarter were driven by strong new patient accruals but were partially offset by order timing in certain ex-US markets and foreign currency impact.
Operating expenses (adjusted basis) were $85.5 million, down 8.7% year over year.
As of Sep 30, 2022, Amicus Therapeutics had cash, cash equivalents and marketable securities of $354.7 million compared with $368.8 million on Jun 30, 2022.
Maintains 2022 Guidance
For the full year, Amicus Therapeutics expects total Galafold revenue growth between 15% and 20% at CER driven by continued underlying demand from geographic expansion, continued diagnosis of new Fabry patients and commercial execution across all major markets, including the United States, European Union, United Kingdom and Japan.
Adjusted operating expenses for the year have been updated and are presently estimated between $430-$440 million, down from the previous estimate of $470-$485 million. The downside can be attributed to prudent expense management and offset by continued investments for the global Galafold launch, AT-GAA clinical studies and pre-launch activities
Other Updates
The lead pipeline candidate in Amicus Therapeutics’ 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 Biologic License Application (BLA), reflective of 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-elated 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.
In the EU, Amicus Therapeutics completed the marketing authorization application (MAA) submissions for AT-GAA in fourth-quarter 2021. A positive opinion on the MAA by the EMA’s Committee for Medicinal Products for Human Use (CHMP) is expected in December this year
Amicus Therapeutics, Inc. Price, Consensus and EPS Surprise
Amicus Therapeutics, Inc. price-consensus-eps-surprise-chart | Amicus Therapeutics, Inc. Quote
Zacks Rank & Other Stocks to Consider
Amicus Therapeutics currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the overall health sector are Puma Biotechnology (PBYI - Free Report) , sporting a Zacks Rank #1 (Strong Buy), Kodiak Sciences (KOD - Free Report) and AVEO Pharmaceuticals each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Puma Biotechnology’s loss estimates for 2022 have remained steady at 6 cents over the past 30 days. Shares of PBYI have returned 29.5% year to date. Earnings of Puma beat earnings estimates in three of the trailing four quarters and missed the same in the remaining occasion. PBYI delivered an earnings surprise of 201.37%, on average.
Kodiak Sciences’ loss estimates for 2022 have remained steady at $7.12 over the past 30 days. Shares of Kodiak have declined 91.8% year to date. Earnings of KOD beat earnings estimates only once in the last four quarters. KOD delivered a negative earnings surprise of 20.20%, on average
AVEO Pharmaceuticals’ loss estimates for 2022 have improved from 94 cents to 76 cents in the past 30 days. Shares of Aveo have returned 214.1% year to date. Earnings of AVEO beat earnings estimates in three of the trailing four quarters, while missing the same in one. AVEO delivered a positive earnings surprise of 13.10%, on average.