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BioMarin (BMRN) Beats on Q2 Earnings, Ups 2021 Guidance
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BioMarin Pharmaceutical Inc.’s (BMRN - Free Report) second-quarter 2021 adjusted earnings of 53 cents per share beat the Zacks Consensus Estimate of 30 cents. Earnings surged 65.6% year over year on higher gross profit.
Total revenues were $501.7 million in the reported quarter, up 17% from the year-ago period’s figure. Sales also beat the Zacks Consensus Estimate of $449 million.
Shares of BioMarin have declined 10.2% so far this year compared with the industry’s decrease of 2.8%.
Image Source: Zacks Investment Research
Quarterly Details
Product revenues (including Aldurazyme) were $486.7 million in the quarter, up 16.1% year over year. Product revenues from BioMarin's marketed brands (excluding Aldurazyme) increased 19% year over year to $458.6 million. Royalty and other revenues were $15 million in the quarter, up 43.7%.
In the phenylketonuria (PKU) franchise, Kuvan revenues declined 36% to $78.8 million due to generic competition as the drug lost U.S. market exclusivity in October 2020. Palynziq injection sales grossed $59 million in the quarter, up 45% year over year, driven by the growing number of U.S. patients who now achieved maintenance dosing as well as new patients initiating therapy. Total sales of PKU franchise declined 16% year over year to $137.8 million.
Naglazyme sales increased 47% to $118.8 million. Vimizim contributed $171.7 million to total revenues, up 47% year over year. Sales of both Naglazyme and Vimizim benefited from the favorable timing of orders from the Middle East and Europe. Naglazyme and Vimzim revenues vary on a quarterly basis, primarily according to the timing of central government orders from some countries.
Brineura generated sales of $30.3 million in the quarter, up 17% year over year. On the second-quarter conference call, management stated that Naglazyme, Vimizim and Brineura maintained a strong patient compliance and continued to grow on strong underlying demand.
Product revenues from Aldurazyme totaled $28.1 million, down 13% year over year.
Sanofi’s (SNY - Free Report) subsidiary Genzyme is BioMarin's sole customer for Aldurazyme and is responsible for marketing and selling Aldurazyme to third parties.
R&D expenses declined 1.5% year over year to $133.2 million while SG&A expenses increased 3.7% to $151.5 million.
2021 Guidance
BioMarin raised its financial guidance for the year. The company now expects total revenues in the range of $1.79-$1.88 billion compared with the earlier projection of $1.75-$1.85 billion. The Zacks Consensus Estimate stands at $1.83 billion.
Vimizim sales are expected in the range of $580-$620 million compared with the previous guidance of $570-$610 million. Kuvan sales are anticipated in the range of $260-$290 million compared with the previous expectation of $250-$290 million. Naglazyme sales range is $375-$405 million compared with the previous range of $365-$395 million. Palynziq sales are expected in the range of $220-$260 million compared with the previous range of $210-$250 million.
Brineura sales are expected within $120-$140 million, unchanged from its previous expectation.
R&D costs are expected in the $645-$685 million band, which was previously expected within $645-$695 million. SG&A expenses are anticipated in the range of $735-$775 million, which was earlier anticipated within $725-$775 million.
The company now expects adjusted net income in the range of $190-$240 million, which was earlier expected in the band of $170-$220 million.
Pipeline Update
Earlier this month, the European Medicines Agency (EMA) validated BioMarin’s marketing authorization application (MAA) for the investigational gene therapy valoctocogene roxaparvovec for treating adult patients with severe hemophilia A. An opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) is expected in the first half of 2022.
In June, the company re-submitted the MAA for valoctocogene roxaparvovec to the European Commission. The company had withdrawn the MAA for valoctocogene roxaparvovec in the EU last year.
Also, in May 2021, the EMA granted accelerated assessment for the review of valoctocogene roxaparvovec. The accelerated assessment is likely to reduce the time period for the EMA’s CHMP and Committee for Advanced Therapies to review the MAA for valoctocogene roxaparvovec from 210 days to 150 days.
We remind investors that last August, the FDA issued a complete response letter (CRL) to valoctocogene roxaparvovec’s biologics license application (BLA), ahead of the Aug 21 PDUFA date as it was not satisfied with the available data. The FDA asked for two-year follow-up data on annualized bleed rates from the ongoing phase III GENEr8-1 study to have additional evidence of a durable effect. This data is not expected to be available before November 2021.
Investors were expecting the FDA to grant an accelerated approval to the drug on the PDUFA date. However, the CRL delayed the potential approval for valoctocogene roxaparvovec. A BLA on the same is expected to be re-filed to the regulatory body in the second quarter of 2022.
Another important candidate in the company’s pipeline is vosoritide, which was developed to treat achondroplasia, the most common form of dwarfism. In the United States, the new drug application (NDA) for the drug is under a priority review with the FDA with a PDUFA target date of November 2021.
Once approved, the drug will be marketed under the trade name Voxzogo.
In June 2021, BioMarin received a positive recommendation from the CHMP for vosoritide to treat achondroplasia. The company anticipates the approval from the European Commission (EC) in third-quarter 2021.
BioMarin Pharmaceutical Inc. Price, Consensus and EPS Surprise
Bio-Techne’s earnings estimates have been revised 2.3% upward for 2021 and 4.2% for 2022 over the past 60 days. The stock has rallied 50.1% year to date.
Repligen’s earnings estimates have been revised 2.3% upward for 2021 and 3.5% for 2022 over the past 60 days. The stock has increased 22.8% year to date.
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BioMarin (BMRN) Beats on Q2 Earnings, Ups 2021 Guidance
BioMarin Pharmaceutical Inc.’s (BMRN - Free Report) second-quarter 2021 adjusted earnings of 53 cents per share beat the Zacks Consensus Estimate of 30 cents. Earnings surged 65.6% year over year on higher gross profit.
Total revenues were $501.7 million in the reported quarter, up 17% from the year-ago period’s figure. Sales also beat the Zacks Consensus Estimate of $449 million.
Shares of BioMarin have declined 10.2% so far this year compared with the industry’s decrease of 2.8%.
Image Source: Zacks Investment Research
Quarterly Details
Product revenues (including Aldurazyme) were $486.7 million in the quarter, up 16.1% year over year. Product revenues from BioMarin's marketed brands (excluding Aldurazyme) increased 19% year over year to $458.6 million. Royalty and other revenues were $15 million in the quarter, up 43.7%.
In the phenylketonuria (PKU) franchise, Kuvan revenues declined 36% to $78.8 million due to generic competition as the drug lost U.S. market exclusivity in October 2020. Palynziq injection sales grossed $59 million in the quarter, up 45% year over year, driven by the growing number of U.S. patients who now achieved maintenance dosing as well as new patients initiating therapy. Total sales of PKU franchise declined 16% year over year to $137.8 million.
Naglazyme sales increased 47% to $118.8 million. Vimizim contributed $171.7 million to total revenues, up 47% year over year. Sales of both Naglazyme and Vimizim benefited from the favorable timing of orders from the Middle East and Europe. Naglazyme and Vimzim revenues vary on a quarterly basis, primarily according to the timing of central government orders from some countries.
Brineura generated sales of $30.3 million in the quarter, up 17% year over year. On the second-quarter conference call, management stated that Naglazyme, Vimizim and Brineura maintained a strong patient compliance and continued to grow on strong underlying demand.
Product revenues from Aldurazyme totaled $28.1 million, down 13% year over year.
Sanofi’s (SNY - Free Report) subsidiary Genzyme is BioMarin's sole customer for Aldurazyme and is responsible for marketing and selling Aldurazyme to third parties.
R&D expenses declined 1.5% year over year to $133.2 million while SG&A expenses increased 3.7% to $151.5 million.
2021 Guidance
BioMarin raised its financial guidance for the year. The company now expects total revenues in the range of $1.79-$1.88 billion compared with the earlier projection of $1.75-$1.85 billion. The Zacks Consensus Estimate stands at $1.83 billion.
Vimizim sales are expected in the range of $580-$620 million compared with the previous guidance of $570-$610 million. Kuvan sales are anticipated in the range of $260-$290 million compared with the previous expectation of $250-$290 million. Naglazyme sales range is $375-$405 million compared with the previous range of $365-$395 million. Palynziq sales are expected in the range of $220-$260 million compared with the previous range of $210-$250 million.
Brineura sales are expected within $120-$140 million, unchanged from its previous expectation.
R&D costs are expected in the $645-$685 million band, which was previously expected within $645-$695 million. SG&A expenses are anticipated in the range of $735-$775 million, which was earlier anticipated within $725-$775 million.
The company now expects adjusted net income in the range of $190-$240 million, which was earlier expected in the band of $170-$220 million.
Pipeline Update
Earlier this month, the European Medicines Agency (EMA) validated BioMarin’s marketing authorization application (MAA) for the investigational gene therapy valoctocogene roxaparvovec for treating adult patients with severe hemophilia A. An opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) is expected in the first half of 2022.
In June, the company re-submitted the MAA for valoctocogene roxaparvovec to the European Commission. The company had withdrawn the MAA for valoctocogene roxaparvovec in the EU last year.
Also, in May 2021, the EMA granted accelerated assessment for the review of valoctocogene roxaparvovec. The accelerated assessment is likely to reduce the time period for the EMA’s CHMP and Committee for Advanced Therapies to review the MAA for valoctocogene roxaparvovec from 210 days to 150 days.
We remind investors that last August, the FDA issued a complete response letter (CRL) to valoctocogene roxaparvovec’s biologics license application (BLA), ahead of the Aug 21 PDUFA date as it was not satisfied with the available data. The FDA asked for two-year follow-up data on annualized bleed rates from the ongoing phase III GENEr8-1 study to have additional evidence of a durable effect. This data is not expected to be available before November 2021.
Investors were expecting the FDA to grant an accelerated approval to the drug on the PDUFA date. However, the CRL delayed the potential approval for valoctocogene roxaparvovec. A BLA on the same is expected to be re-filed to the regulatory body in the second quarter of 2022.
Another important candidate in the company’s pipeline is vosoritide, which was developed to treat achondroplasia, the most common form of dwarfism. In the United States, the new drug application (NDA) for the drug is under a priority review with the FDA with a PDUFA target date of November 2021.
Once approved, the drug will be marketed under the trade name Voxzogo.
In June 2021, BioMarin received a positive recommendation from the CHMP for vosoritide to treat achondroplasia. The company anticipates the approval from the European Commission (EC) in third-quarter 2021.
BioMarin Pharmaceutical Inc. Price, Consensus and EPS Surprise
BioMarin Pharmaceutical Inc. price-consensus-eps-surprise-chart | BioMarin Pharmaceutical Inc. Quote
Zacks Rank & Other Stocks to Consider
BioMarin currently carries a Zacks Rank #2 (Buy). Other stocks worth considering in the biotech sector include Bio-Techne Corporation (TECH - Free Report) and Repligen Corporation (RGEN - Free Report) , both carrying the same Zacks Rank of 2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Bio-Techne’s earnings estimates have been revised 2.3% upward for 2021 and 4.2% for 2022 over the past 60 days. The stock has rallied 50.1% year to date.
Repligen’s earnings estimates have been revised 2.3% upward for 2021 and 3.5% for 2022 over the past 60 days. The stock has increased 22.8% year to date.