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Amicus' (FOLD) Q3 Loss Narrows, Galafold Sales View Updated
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Amicus Therapeutics, Inc. (FOLD - Free Report) reported third-quarter 2023 loss of 7 cents per share, narrower than the Zacks Consensus Estimate of a loss of 8 cents. The company had reported a loss of 12 cents per share in the year-ago quarter.
The year-over-year improvement can be attributed to Galafold revenue growth and careful expense management by the company.
Revenues in the third quarter totaled $103.5 million, up 27% year over year. The figure beat the Zacks Consensus Estimate of $101 million. The top line comprised sales of Galafold (migalastat), approved for Fabry disease. On a constant-currency (cc) basis, total year-over-year revenue growth was 22%.
Quarter in Detail
Galafold net product sales were $100.7 million in the third quarter, reflecting an increase of 19% year over year at cc. The drug’s sales beat our model estimate of $93.7 million.
Net product sales of newly approved Pombiliti + Opfolda were $2.8 million in the third quarter, representing sales in Germany and the United Kingdom.
Adjusted research and development expenses decreased 23.7% year over year to $36.3 million.
Adjusted selling, general and administrative expenses totaled almost $53.5 million, up 40.8% from the year-ago quarter’s level.
As of Sep 30, 2023, Amicus had cash, cash equivalents and marketable securities worth $280.3 million compared with $265.6 million as of Jun 30, 2023.
Shares of Amicus have lost 7% in the year-to-date period compared with the industry’s 20.9% decline.
Image Source: Zacks Investment Research
Galafold View Tightened
The company tightened its previously issued guidance for 2023, reflecting the strong performance of Galafold.
Amicus now expects total Galafold revenue growth of 16-18% at cc compared with the previous projection of 14-18%. This was due to continued patient demand from both switch and treatment-naïve patients, expansion into other geographies, label extensions, continued diagnosis of new Fabry patients and commercial execution across all major markets, including the EU, Japan, the U.K. and the United States.
Adjusted operating expenses are estimated in the band of $330-$350 million, unchanged from the previous expectation.
The company targets to achieve profitability on a non-GAAP basis in the fourth quarter of 2023.
Recent Updates
In September 2023, the FDA approved Pombiliti (cipaglucosidase alfa) + Opfolda (miglustat) 65mg capsules, a two-component therapy for treating late-onset Pompe disease (LOPD) in adults who weigh over 40 kg and are not improving on their current enzyme replacement therapy.
Cipaglucosidase alfa is a long-term enzyme replacement therapy and miglustat is an enzyme stabilizer component.
The FDA nod was based on positive data from the phase III PROPEL study, the only randomized, controlled trial in LOPD.
We note that, the approval in the United States is a huge boost and provides a significant commercial opportunity for Amicus in 2024 and beyond.
Amicus Therapeutics, Inc. Price, Consensus and EPS Surprise
In the past 60 days, estimates for Dynavax Technologies’ 2023 loss per share have narrowed from 24 cents to 12 cents. Meanwhile, during the same period, earnings per share estimates for 2024 have improved from 2 cents to 18 cents. Year to date, shares of DVAX have rallied 24.8%.
Earnings of Dynavax Technologies beat estimates in two of the last three quarters while missing the same on the remaining two occasions. DVAX delivered a four-quarter average earnings surprise of 24.28%.
In the past 60 days, estimates for MEI Pharma’s 2023 loss per share have improved from $6.54 to $4.89. During the same period, loss per share estimates for 2024 have narrowed from $5.14 to $4.02. Year to date, shares of MEIP have rallied 46.6%.
Earnings of MEI Pharma beat estimates in three of the trailing four quarters and met the same on the other occasion. On average, MEIP came up with a four-quarter earnings surprise of 53.58%.
In the past 60 days, Ligand Pharmaceuticals’ earnings per share estimates for 2023 have improved from $4.98 to $5.10. During the same period, earnings per share estimates for 2024 have moved up from $4.26 to $4.59. Year to date, shares of LGND have lost 21.8%.
Earnings of Ligand Pharmaceuticals beat estimates in three of the trailing four quarters and missed the same on the other occasion. On average, LGND came up with a four-quarter earnings surprise of 52.47%.
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Amicus' (FOLD) Q3 Loss Narrows, Galafold Sales View Updated
Amicus Therapeutics, Inc. (FOLD - Free Report) reported third-quarter 2023 loss of 7 cents per share, narrower than the Zacks Consensus Estimate of a loss of 8 cents. The company had reported a loss of 12 cents per share in the year-ago quarter.
The year-over-year improvement can be attributed to Galafold revenue growth and careful expense management by the company.
Revenues in the third quarter totaled $103.5 million, up 27% year over year. The figure beat the Zacks Consensus Estimate of $101 million. The top line comprised sales of Galafold (migalastat), approved for Fabry disease. On a constant-currency (cc) basis, total year-over-year revenue growth was 22%.
Quarter in Detail
Galafold net product sales were $100.7 million in the third quarter, reflecting an increase of 19% year over year at cc. The drug’s sales beat our model estimate of $93.7 million.
Net product sales of newly approved Pombiliti + Opfolda were $2.8 million in the third quarter, representing sales in Germany and the United Kingdom.
Adjusted research and development expenses decreased 23.7% year over year to $36.3 million.
Adjusted selling, general and administrative expenses totaled almost $53.5 million, up 40.8% from the year-ago quarter’s level.
As of Sep 30, 2023, Amicus had cash, cash equivalents and marketable securities worth $280.3 million compared with $265.6 million as of Jun 30, 2023.
Shares of Amicus have lost 7% in the year-to-date period compared with the industry’s 20.9% decline.
Galafold View Tightened
The company tightened its previously issued guidance for 2023, reflecting the strong performance of Galafold.
Amicus now expects total Galafold revenue growth of 16-18% at cc compared with the previous projection of 14-18%. This was due to continued patient demand from both switch and treatment-naïve patients, expansion into other geographies, label extensions, continued diagnosis of new Fabry patients and commercial execution across all major markets, including the EU, Japan, the U.K. and the United States.
Adjusted operating expenses are estimated in the band of $330-$350 million, unchanged from the previous expectation.
The company targets to achieve profitability on a non-GAAP basis in the fourth quarter of 2023.
Recent Updates
In September 2023, the FDA approved Pombiliti (cipaglucosidase alfa) + Opfolda (miglustat) 65mg capsules, a two-component therapy for treating late-onset Pompe disease (LOPD) in adults who weigh over 40 kg and are not improving on their current enzyme replacement therapy.
Cipaglucosidase alfa is a long-term enzyme replacement therapy and miglustat is an enzyme stabilizer component.
The FDA nod was based on positive data from the phase III PROPEL study, the only randomized, controlled trial in LOPD.
We note that, the approval in the United States is a huge boost and provides a significant commercial opportunity for Amicus in 2024 and beyond.
Amicus Therapeutics, Inc. Price, Consensus and EPS Surprise
Amicus Therapeutics, Inc. price-consensus-eps-surprise-chart | Amicus Therapeutics, Inc. Quote
Zacks Rank & Stocks to Consider
Amicus currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Dynavax Technologies Corporation (DVAX - Free Report) , MEI Pharma, Inc. (MEIP - Free Report) and Ligand Pharmaceuticals Incorporated , sporting a Zacks Rank #1 (Strong Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Dynavax Technologies’ 2023 loss per share have narrowed from 24 cents to 12 cents. Meanwhile, during the same period, earnings per share estimates for 2024 have improved from 2 cents to 18 cents. Year to date, shares of DVAX have rallied 24.8%.
Earnings of Dynavax Technologies beat estimates in two of the last three quarters while missing the same on the remaining two occasions. DVAX delivered a four-quarter average earnings surprise of 24.28%.
In the past 60 days, estimates for MEI Pharma’s 2023 loss per share have improved from $6.54 to $4.89. During the same period, loss per share estimates for 2024 have narrowed from $5.14 to $4.02. Year to date, shares of MEIP have rallied 46.6%.
Earnings of MEI Pharma beat estimates in three of the trailing four quarters and met the same on the other occasion. On average, MEIP came up with a four-quarter earnings surprise of 53.58%.
In the past 60 days, Ligand Pharmaceuticals’ earnings per share estimates for 2023 have improved from $4.98 to $5.10. During the same period, earnings per share estimates for 2024 have moved up from $4.26 to $4.59. Year to date, shares of LGND have lost 21.8%.
Earnings of Ligand Pharmaceuticals beat estimates in three of the trailing four quarters and missed the same on the other occasion. On average, LGND came up with a four-quarter earnings surprise of 52.47%.