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BioMarin Pharmaceutical (BMRN - Free Report) reported adjusted earnings of 45 cents per share in third-quarter 2022, beating the Zacks Consensus Estimate and our estimates of 37 cents and 35 cents, respectively. Earnings rose 150% from the year-ago quarter’s figure, driven by higher year-over-year revenues, which offset the impact of higher marketing costs.
Total revenues were $505.3 million in the reported quarter, up 24% from the year-ago quarter’s level. However, revenues missed the Zacks Consensus Estimate and our estimate of $513 million and $515.5 million, respectively.
Following the earnings announcement, shares of BioMarin declined 2.3% in after-market trading on Oct 26. In the year so far, the stock has increased 4.2% against the industry’s fall of 24.5%
Image Source: Zacks Investment Research
Quarter in Detail
Product revenues (including Aldurazyme) were $493.3 million in the quarter, up 25.3% year over year. Product revenues from BioMarin's marketed brands (excluding Aldurazyme) were up 26% year over year to $464.3 million on higher revenues from the new drug, Voxzogo, which offset lower sales of Kuvan. Royalty and other revenues were $12.0 million in the quarter, down 19.5%.
Vimizim sales were up 14% year over year to $155.5 million. Naglazyme sales were up 40% to $99.5 million. Vimizim and Naglazyme sales upside can be attributed to the favorable timing of large irregular orders in some countries in Europe and Latin America during the quarter. While Naglazyme sales beat our expectations of $95.1 million, Vimizim sales missed our model estimate of $162.9 million.
Brineura generated sales of $37.8 million in the quarter, up 15% year over year, driven by 20% year-over-year growth in commercial patients. The drug’s sales, however, missed our model estimate of $40.7 million for the quarter.
The new drug Voxzogo, approved last year in the United States and Europe to treat achondroplasia, generated sales worth $48.3 million in the third quarter compared with $34.4 million in the second quarter. Higher sales of Voxzogo were driven by new patients initiating therapy in Europe and the United States. As of Sep 30, an estimated 713 children were being treated with Voxzogo. During the quarter, Voxzogo was approved in Japan, accounting for half of the 1,500-patient opportunity in the Asia-Pacific region. The Voxzogo sales figure also beat our model estimates of $42.5 million.
In the phenylketonuria (PKU) franchise, Kuvan revenues declined 16% to $57 million due to generic competition, as the drug lost U.S. market exclusivity in late 2020.
Palynziq injection sales grossed $66.2 million in the quarter, up 9% year over year. Though the growth in sales was below management expectations, management expects the drug’s growth to reach within their expectations in the long term. 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 $29 million, up 19% likely 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. The Sanofi subsidiary is also responsible for marketing and selling Aldurazyme to third parties.
Updates 2022 Guidance
BioMarin reiterated its previously-issued total revenue and earnings guidance for 2022. Management expects to record sales in the range of $2.06-$2.16 billion, backed by growth of Voxzogo. The company reiterates its total revenue guidance despite ongoing currency headwinds.
However, BioMarin has raised the sales guidance for Voxzogo for the full year 2022. It now expects to record the drug’s sales in the range of $140-$170 million, up from the previous guidance of $130-$160 million, backed by robust demand for the drug in the United States and Europe.
Management, however, maintained its guidance for the other marketed drugs. Vimizim sales are expected in the range of $655-$700 million, while Kuvan sales are anticipated in the range of $210-$235 million. Palynziq and Naglazyme sales are expected in the range of $250-$275 million and $415-$450 million, respectively. Brineura sales are expected within $145-$160 million.
While the company slightly raised its guidance for selling, general and administrative (SGA) expenses, it slightly reduced its projections for research and development (R&D) costs. The company now expects R&D expenses in the range of $650-$700 million (previously $665-$715 million) and SGA expenses in between the $800-$850 million range (previously $790-$840 million).
BioMarin maintained its adjusted net income guidance in the range of $350-$390 million.
Pipeline Updates
This August, the European Commission granted conditional approval to valoctocogene roxaparvovec (valrox), a gene therapy for treating adults with severe hemophilia A. The therapy will be marketed by BioMarin under the trade name Roctavian for which management has already initiated launch preparations in Europe. Management expects the Roctavian product launch by year-end.
Last month, BioMarin refiled its biologics license application (BLA) with the FDA for Roctavian. The BLA has been accepted for review and an FDA decision is expected by March 2023-end. The FDA is also planning to seek an advisory committee’s recommendation for the drug’s approval.
BioMarin is also planning to seek label expansion for Voxzogo in infants and young children up to five years of age with achondroplasia. In this regard, management expects to submit regulatory filings by year-end.
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.
In the past 60 days, estimates for Codiak BioSciences’ 2022 loss per share have narrowed from $1.94 to $1.81. During the same period, the loss estimates per share for 2023 have narrowed from $2.14 to $1.53. Shares of Codiak BioSciences have lost 93.6% in the year-to-date period.
Earnings of Codiak BioSciences beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 35.40% on average. In the last reported quarter, CDAK delivered an earnings surprise of 61.54%.
In the past 60 days, estimates for Morphic’s 2023 loss per share have narrowed from $3.77 to $3.61 during the same period. Shares of Morphic have lost 40.8% in the year-to-date period.
Earnings of Morphic beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 48.29%, on average. In the last reported quarter, MORF delivered an earnings surprise of 183.95%.
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BioMarin (BMRN) Q3 Earnings Beat, Sales Miss, Ups Voxzogo View
BioMarin Pharmaceutical (BMRN - Free Report) reported adjusted earnings of 45 cents per share in third-quarter 2022, beating the Zacks Consensus Estimate and our estimates of 37 cents and 35 cents, respectively. Earnings rose 150% from the year-ago quarter’s figure, driven by higher year-over-year revenues, which offset the impact of higher marketing costs.
Total revenues were $505.3 million in the reported quarter, up 24% from the year-ago quarter’s level. However, revenues missed the Zacks Consensus Estimate and our estimate of $513 million and $515.5 million, respectively.
Following the earnings announcement, shares of BioMarin declined 2.3% in after-market trading on Oct 26. In the year so far, the stock has increased 4.2% against the industry’s fall of 24.5%
Image Source: Zacks Investment Research
Quarter in Detail
Product revenues (including Aldurazyme) were $493.3 million in the quarter, up 25.3% year over year. Product revenues from BioMarin's marketed brands (excluding Aldurazyme) were up 26% year over year to $464.3 million on higher revenues from the new drug, Voxzogo, which offset lower sales of Kuvan. Royalty and other revenues were $12.0 million in the quarter, down 19.5%.
Vimizim sales were up 14% year over year to $155.5 million. Naglazyme sales were up 40% to $99.5 million. Vimizim and Naglazyme sales upside can be attributed to the favorable timing of large irregular orders in some countries in Europe and Latin America during the quarter. While Naglazyme sales beat our expectations of $95.1 million, Vimizim sales missed our model estimate of $162.9 million.
Brineura generated sales of $37.8 million in the quarter, up 15% year over year, driven by 20% year-over-year growth in commercial patients. The drug’s sales, however, missed our model estimate of $40.7 million for the quarter.
The new drug Voxzogo, approved last year in the United States and Europe to treat achondroplasia, generated sales worth $48.3 million in the third quarter compared with $34.4 million in the second quarter. Higher sales of Voxzogo were driven by new patients initiating therapy in Europe and the United States. As of Sep 30, an estimated 713 children were being treated with Voxzogo. During the quarter, Voxzogo was approved in Japan, accounting for half of the 1,500-patient opportunity in the Asia-Pacific region. The Voxzogo sales figure also beat our model estimates of $42.5 million.
In the phenylketonuria (PKU) franchise, Kuvan revenues declined 16% to $57 million due to generic competition, as the drug lost U.S. market exclusivity in late 2020.
Palynziq injection sales grossed $66.2 million in the quarter, up 9% year over year. Though the growth in sales was below management expectations, management expects the drug’s growth to reach within their expectations in the long term. 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 $29 million, up 19% likely 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. The Sanofi subsidiary is also responsible for marketing and selling Aldurazyme to third parties.
Updates 2022 Guidance
BioMarin reiterated its previously-issued total revenue and earnings guidance for 2022. Management expects to record sales in the range of $2.06-$2.16 billion, backed by growth of Voxzogo. The company reiterates its total revenue guidance despite ongoing currency headwinds.
However, BioMarin has raised the sales guidance for Voxzogo for the full year 2022. It now expects to record the drug’s sales in the range of $140-$170 million, up from the previous guidance of $130-$160 million, backed by robust demand for the drug in the United States and Europe.
Management, however, maintained its guidance for the other marketed drugs. Vimizim sales are expected in the range of $655-$700 million, while Kuvan sales are anticipated in the range of $210-$235 million. Palynziq and Naglazyme sales are expected in the range of $250-$275 million and $415-$450 million, respectively. Brineura sales are expected within $145-$160 million.
While the company slightly raised its guidance for selling, general and administrative (SGA) expenses, it slightly reduced its projections for research and development (R&D) costs. The company now expects R&D expenses in the range of $650-$700 million (previously $665-$715 million) and SGA expenses in between the $800-$850 million range (previously $790-$840 million).
BioMarin maintained its adjusted net income guidance in the range of $350-$390 million.
Pipeline Updates
This August, the European Commission granted conditional approval to valoctocogene roxaparvovec (valrox), a gene therapy for treating adults with severe hemophilia A. The therapy will be marketed by BioMarin under the trade name Roctavian for which management has already initiated launch preparations in Europe. Management expects the Roctavian product launch by year-end.
Last month, BioMarin refiled its biologics license application (BLA) with the FDA for Roctavian. The BLA has been accepted for review and an FDA decision is expected by March 2023-end. The FDA is also planning to seek an advisory committee’s recommendation for the drug’s approval.
BioMarin is also planning to seek label expansion for Voxzogo in infants and young children up to five years of age with achondroplasia. In this regard, management expects to submit regulatory filings by year-end.
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.
BioMarin Pharmaceutical Inc. Price
BioMarin Pharmaceutical Inc. price | BioMarin Pharmaceutical Inc. Quote
Zacks Rank & Other Stocks to Consider
Currently, BioMarin carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the overall healthcare sector include Codiak BioSciences and Morphic (MORF - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Codiak BioSciences’ 2022 loss per share have narrowed from $1.94 to $1.81. During the same period, the loss estimates per share for 2023 have narrowed from $2.14 to $1.53. Shares of Codiak BioSciences have lost 93.6% in the year-to-date period.
Earnings of Codiak BioSciences beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 35.40% on average. In the last reported quarter, CDAK delivered an earnings surprise of 61.54%.
In the past 60 days, estimates for Morphic’s 2023 loss per share have narrowed from $3.77 to $3.61 during the same period. Shares of Morphic have lost 40.8% in the year-to-date period.
Earnings of Morphic beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 48.29%, on average. In the last reported quarter, MORF delivered an earnings surprise of 183.95%.