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BioMarin Pharmaceutical (BMRN - Free Report) reported second-quarter 2022 adjusted earnings of 59 cents per share, beating the Zacks Consensus Estimate of 43 cents. Earnings rose 11.3% from the year-ago quarter’s figure driven by higher revenues, which offset the impact of higher marketing costs.
Total revenues were $533.8 million in the reported quarter, up 6% from the year-ago quarter’s level. The revenues beat the Zacks Consensus Estimate of $511 million.
In the year so far, BioMarin’s stock is up 0.1% against the industry’s fall of 22%.
Quarter in Detail
Product revenues (including Aldurazyme) were $517.7 million in the quarter, up 6.4% year over year. Product revenues from BioMarin's marketed brands (excluding Aldurazyme) were up 5% year over year to $480.4 million on higher revenues from the new drug, Voxzogo, which offset lower sales of Kuvan and Naglazyme. Royalty and other revenues were $16.1 million in the quarter, up 7.4%.
Vimizim sales were up 1% year over year to $173.3 million, while Naglazyme sales declined 3% to $115.8 million. Vimzim and Naglazyme sales were lower than in the first quarter due to the volume of large irregular orders placed in the first quarter. Both Naglazyme and Vimzim experience uneven quarterly revenue patterns.
Brineura generated sales of $37.7 million in the quarter, up 24% year over year, driven by 18% year-over-year growth in commercial patients.
The new drug Voxzogo, approved last year in the United States and Europe to treat achondroplasia, generated sales worth $34.4 million in the second quarter compared with $19.7 million in the first quarter. Higher sales of Voxzogo were driven by new patients initiating therapy in Europe as well as the United States. As of Jun 30, an estimated 446 children were being treated with Voxzogo, of which 164 were from the United States and 282 from international markets. Voxzogo was approved in Japan and Australia in the quarter.
In the phenylketonuria (PKU) franchise, Kuvan revenues declined 27% to $57.6 million due to generic competition as the drug lost U.S. market exclusivity in late 2020.
Palynziq injection sales grossed $61.6 million in the quarter, up 4% year over year. Sales were below management expectations. BioMarin expects Palynziq patient trends to grow at a slower pace than initial expectations. Palynziq sales continue to be hurt as PKU clinics particularly in the United States, to treat adult PKU patients with Palynziq, have not recovered their capacity lost due to the pandemic.
Product revenues from Aldurazyme totaled $37.3 million, up 33% due to the favorable timing of product fulfillment to Sanofi’s (SNY - Free Report) subsidiary, Genzyme.
BioMarin has a collaboration agreement with Sanofi’s Genzyme for Aldurazyme. Sanofi through Genzyme is BioMarin's sole customer for Aldurazyme and is responsible for marketing and selling Aldurazyme to third parties.
2022 Sales View Up Slightly
Despite ongoing economic challenges like currency fluctuations, BioMarin slightly raised its previously issued sales guidance for 2022 from a range of $2.05-$2.15 billion to $2.06-$2.16 billion, backed by the growth of Voxzogo.
BioMarin now expects to record Voxzogo sales in the range of $130-$160 million in 2022, up from the previous guidance of $100-$125 million, backed by robust demand for the drug in the United States and Europe.
Vimizim sales are expected in the range of $655-$700 million (previously $650-$700 million). Kuvan sales are anticipated in the range of $210-$235 million (previously $225-$250 million). Palynziq sales are expected in the range of $250-$275 million (previously $280-$310 million). Naglazyme sales are expected between $415 million and $450 million (previously $400 million and $440 million). Brineura sales are expected within $145-$160 million (maintained). BioMarin expects Roctavian to be a modest contributor to second-half revenues.
BioMarin maintained its adjusted net income guidance in the range of $350-$390 million.
Pipeline Update
BioMarin’s biologics license application (BLA) for Roctavian/valoctocogene roxaparvovec (valrox), a gene therapy for severe hemophilia A, was given a complete response letter (CRL) by the FDA in August 2020 while the marketing authorization application (MAA) in Europe was withdrawn. BioMarin resubmitted the MAA along with this one-year data to the European Medicines Agency (EMA) in June 2021. BioMarin announced two-year follow-up safety and efficacy data from the phase III GENEr8-1 study in January 2022 and submitted the same to the EMA.
In June, the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) issued a positive opinion recommending the approval of valoctocogene roxaparvovec. A final decision of the European Commission is expected in a couple of months. A BLA is expected to be re-filed with the FDA in September, delayed from the earlier timeline of June 2022. Along with the earnings release, BioMarin said that the review procedure should take nine months rather than the normal six-month review procedure as several related data-readouts are expected during that time.
Another gene therapy candidate in BioMarin’s pipeline is BMN 331 for the treatment of hereditary angioedema. A phase I/II HAERMONY study on BMN 331 is ongoing and patients have been dosed.
Deciphera Pharmaceuticals’ loss per share estimates for 2022 have narrowed from $2.62 to $2.57 in the past 30 days. DCPH’s stock has risen 38.9% in the year-to-date period.
Earnings of Deciphera Pharmaceuticals missed estimates in three of the last four quarters and beat the mark once, the average negative surprise being 2.0%.
BioNTech’s stock is down 30.9% this year so far. Earnings estimates for 2022 have gone up from $33.18 per share to $34.28 per share while that for 2023 has increased from $14.28 per share to $20.17 per share over the past 30 days.
Earnings of BioNTech beat estimates in all the last four quarters, the average surprise being 56.87%.
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BioMarin's (BMRN) Q2 Earnings Top, Voxzogo Drives Sales
BioMarin Pharmaceutical (BMRN - Free Report) reported second-quarter 2022 adjusted earnings of 59 cents per share, beating the Zacks Consensus Estimate of 43 cents. Earnings rose 11.3% from the year-ago quarter’s figure driven by higher revenues, which offset the impact of higher marketing costs.
Total revenues were $533.8 million in the reported quarter, up 6% from the year-ago quarter’s level. The revenues beat the Zacks Consensus Estimate of $511 million.
In the year so far, BioMarin’s stock is up 0.1% against the industry’s fall of 22%.
Quarter in Detail
Product revenues (including Aldurazyme) were $517.7 million in the quarter, up 6.4% year over year. Product revenues from BioMarin's marketed brands (excluding Aldurazyme) were up 5% year over year to $480.4 million on higher revenues from the new drug, Voxzogo, which offset lower sales of Kuvan and Naglazyme. Royalty and other revenues were $16.1 million in the quarter, up 7.4%.
Vimizim sales were up 1% year over year to $173.3 million, while Naglazyme sales declined 3% to $115.8 million. Vimzim and Naglazyme sales were lower than in the first quarter due to the volume of large irregular orders placed in the first quarter. Both Naglazyme and Vimzim experience uneven quarterly revenue patterns.
Brineura generated sales of $37.7 million in the quarter, up 24% year over year, driven by 18% year-over-year growth in commercial patients.
The new drug Voxzogo, approved last year in the United States and Europe to treat achondroplasia, generated sales worth $34.4 million in the second quarter compared with $19.7 million in the first quarter. Higher sales of Voxzogo were driven by new patients initiating therapy in Europe as well as the United States. As of Jun 30, an estimated 446 children were being treated with Voxzogo, of which 164 were from the United States and 282 from international markets. Voxzogo was approved in Japan and Australia in the quarter.
In the phenylketonuria (PKU) franchise, Kuvan revenues declined 27% to $57.6 million due to generic competition as the drug lost U.S. market exclusivity in late 2020.
Palynziq injection sales grossed $61.6 million in the quarter, up 4% year over year. Sales were below management expectations. BioMarin expects Palynziq patient trends to grow at a slower pace than initial expectations. Palynziq sales continue to be hurt as PKU clinics particularly in the United States, to treat adult PKU patients with Palynziq, have not recovered their capacity lost due to the pandemic.
Product revenues from Aldurazyme totaled $37.3 million, up 33% due to the favorable timing of product fulfillment to Sanofi’s (SNY - Free Report) subsidiary, Genzyme.
BioMarin has a collaboration agreement with Sanofi’s Genzyme for Aldurazyme. Sanofi through Genzyme is BioMarin's sole customer for Aldurazyme and is responsible for marketing and selling Aldurazyme to third parties.
2022 Sales View Up Slightly
Despite ongoing economic challenges like currency fluctuations, BioMarin slightly raised its previously issued sales guidance for 2022 from a range of $2.05-$2.15 billion to $2.06-$2.16 billion, backed by the growth of Voxzogo.
BioMarin now expects to record Voxzogo sales in the range of $130-$160 million in 2022, up from the previous guidance of $100-$125 million, backed by robust demand for the drug in the United States and Europe.
Vimizim sales are expected in the range of $655-$700 million (previously $650-$700 million). Kuvan sales are anticipated in the range of $210-$235 million (previously $225-$250 million). Palynziq sales are expected in the range of $250-$275 million (previously $280-$310 million). Naglazyme sales are expected between $415 million and $450 million (previously $400 million and $440 million). Brineura sales are expected within $145-$160 million (maintained). BioMarin expects Roctavian to be a modest contributor to second-half revenues.
BioMarin maintained its adjusted net income guidance in the range of $350-$390 million.
Pipeline Update
BioMarin’s biologics license application (BLA) for Roctavian/valoctocogene roxaparvovec (valrox), a gene therapy for severe hemophilia A, was given a complete response letter (CRL) by the FDA in August 2020 while the marketing authorization application (MAA) in Europe was withdrawn. BioMarin resubmitted the MAA along with this one-year data to the European Medicines Agency (EMA) in June 2021. BioMarin announced two-year follow-up safety and efficacy data from the phase III GENEr8-1 study in January 2022 and submitted the same to the EMA.
In June, the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) issued a positive opinion recommending the approval of valoctocogene roxaparvovec. A final decision of the European Commission is expected in a couple of months. A BLA is expected to be re-filed with the FDA in September, delayed from the earlier timeline of June 2022. Along with the earnings release, BioMarin said that the review procedure should take nine months rather than the normal six-month review procedure as several related data-readouts are expected during that time.
Another gene therapy candidate in BioMarin’s pipeline is BMN 331 for the treatment of hereditary angioedema. A phase I/II HAERMONY study on BMN 331 is ongoing and patients have been dosed.
Zacks Rank & Stocks to Consider
Currently, BioMarin carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the same sector worth considering are Deciphera Pharmaceuticals (DCPH - Free Report) and BioNTech (BNTX - 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.
Deciphera Pharmaceuticals’ loss per share estimates for 2022 have narrowed from $2.62 to $2.57 in the past 30 days. DCPH’s stock has risen 38.9% in the year-to-date period.
Earnings of Deciphera Pharmaceuticals missed estimates in three of the last four quarters and beat the mark once, the average negative surprise being 2.0%.
BioNTech’s stock is down 30.9% this year so far. Earnings estimates for 2022 have gone up from $33.18 per share to $34.28 per share while that for 2023 has increased from $14.28 per share to $20.17 per share over the past 30 days.
Earnings of BioNTech beat estimates in all the last four quarters, the average surprise being 56.87%.