Amicus (FOLD) Misses on Q2 Earnings, Raises Revenue Guidance
Amicus Therapeutics FOLD reported a second-quarter 2023 loss of 15 cents per share, wider than the Zacks Consensus Estimate of a loss of 12 cents. The company reported a loss of 21 cents per share in the year-ago quarter.
The year-over-year improvement can be attributed to revenue growth in Galafold and careful expense management by the company.
Revenues in the quarter totaled $94.5 million, up 17% year over year. The figure beat the Zacks Consensus Estimate of $90 million. The top line comprised of sales of Galafold (migalastat), approved for Fabry disease. On a constant-currency (cc) basis, total year-over-year revenue growth was also 17%.
Quarter in Details
Galafold revenues beat our model estimate of $89.6 million.
Adjusted research and development expenses decreased 58% year over year to $31 million.
Adjusted selling, general and administrative expenses totaled almost $53 million, up 17% from the year-ago quarter’s level.
As of Jun 30, 2023, Amicus had cash, cash equivalents and marketable securities worth $265.6 million compared with $267.1 million as of Mar 31, 2023.
Updates 2023 Guidance
The company updated its previously issued guidance for 2023, reflecting strong performance of Galafold.
Shares of Amicus were up almost 10.5% on Aug 8, soon after the company reported earnings. The stock gained 13.5% in the year-to-date period against the industry’s 13% decline.
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FOLD now expects total Galafold revenue growth of 14-18% at cc, up from the previous projection of 12-17%. This was driven by continued underlying demand from both switch and treatment-naïve patients, geographic expansion, label extensions, continued diagnosis of new Fabry patients, and commercial execution across all major markets, including EU, Japan, the U.K. and the United States.
Adjusted operating expenses are estimated in the band of $330-$350 million, down from the previously estimated range of $340-$360 million.
The company plans on achieving profitability on a non-GAAP basis in the second half of 2023.
Other Updates
The lead pipeline candidate in Amicus’ portfolio is AT-GAA with two components — cipaglucosidase alfa and miglustat. The candidate is being developed as a potential treatment for Pompe disease.
In the quarter, FOLD received approval for Opfolda (miglustat) from the European Commission to treat the adult late-onset Pompe disease (LOPD). Earlier in March, Pombiliti (cipaglucosidase alfa) was also approved in Europe for LOPD. Management is moving forward with the launch of Pombiliti + Opfolda in Europe.
The biologics license application (BLA) and new drug application (NDA) for the two components of AT-GAA were accepted by the FDA in September 2021.The FDA has deferred the dates of the NDA and BLA. Amicus completed the required pre-approval inspection of the WuXi Biologics manufacturing site in China.
Management expects regulatory approval and the launch of AT-GAA in the United States in the third quarter of 2023.
Amicus Therapeutics, Inc. Price and Consensus
Amicus Therapeutics, Inc. price-consensus-chart | Amicus Therapeutics, Inc. Quote
Zacks Rank & Other Stocks to Consider
Amicus currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the same industry are ADC Therapeutics ADCT, Acadia Pharmaceuticals ACAD and ImmunoGen IMGN, each carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate for ADC Therapeutics has narrowed from a loss of $2.77 per share to a loss of $2.61 for 2023. The consensus estimate has narrowed from a loss of $2.59 per share to a loss of $2.55 for 2024 during the same time frame. Shares of the company have lost 58.3% year to date.
ADCT’s earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 10.70%.
In the past 90 days, the Zacks Consensus Estimate for Acadia Pharmaceuticals has narrowed from a loss of 58 cents per share to a loss of 41 cents for 2023. The consensus estimate has improved from a loss of 9 cents per share to a profit of 47 cents for 2024 during the same time frame. Shares of the company have rallied 67.9% year to date.
ACAD’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 20.33%.
In the past 90 days, the Zacks Consensus Estimate for ImmunoGen has narrowed from a loss of 55 cents per share to a loss of 21 cents for 2023. The consensus estimate has improved from a loss of 31 cents per share to a profit of 3 cents for 2024 during the same time frame. Shares of the company have rallied 185.1% year to date.
IMGN’s earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 31.24%.
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