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BioMarin (BMRN) Beats on Q3 Earnings, Ups 2021 Guidance
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BioMarin Pharmaceutical Inc.’s (BMRN - Free Report) third-quarter 2021 adjusted earnings of 18 cents per share beat the Zacks Consensus Estimate of 11 cents. Earnings declined 66.6% year over year on lower net product revenues.
Total revenues were $408.7 million in the reported quarter, down 14% from the year-ago period’s figure. Sales lagged the Zacks Consensus Estimate of $432 million.
Shares of BioMarin have declined 18.2% so far this year compared with the industry’s decrease of 9.6%.
Image Source: Zacks Investment Research
Quarterly Details
Product revenues (including Aldurazyme) were $393.8 million in the quarter, down 14.5% year over year. Product revenues from BioMarin's marketed brands (excluding Aldurazyme) decreased 12.0% year over year to $369.5 million. Royalty and other revenues were $14.9 million in the quarter, down 7.1%.
In the phenylketonuria (“PKU”) franchise, Kuvan revenues declined 45% to $67.7 million due to generic competition as the drug lost U.S. market exclusivity in October 2020. Palynziq injection sales grossed $60.7 million in the quarter, up 32% year over year, driven by the growing number of U.S. patients who have now achieved maintenance dosing as well as new patients initiating therapy.
Naglazyme sales decreased 7% to $71.2 million. Vimizim contributed $136.9 million to total revenues, which went down 7% year over year. Lower sales of both Naglazyme and Vimizim were driven by unfavorable 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 $32.9 million in the quarter, up 30% year over year. Management stated that Brineura maintained a strong patient compliance and continued to grow on strong underlying demand.
Product revenues from Aldurazyme totaled $24.4 million, down 40% 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. During the reported quarter Aldurazyme sales declined due to unfavorable timing of product fulfillment to Genzyme.
R&D expenses increased 6.4% year over year to $133.7 million while SG&A expenses marginally increased 0.8% to $151.3 million.
2021 Guidance
BioMarin raised the lower end of its revenue guidance range for the year. The company now expects total revenues in the range of $1.82-$1.88 billion compared with the earlier projection of $1.79-$1.88 billion. The Zacks Consensus Estimate for the same stands at $1.85 billion.
Vimizim sales are expected in the range of $595-$620 million compared with the previous guidance of $580-$620 million. Kuvan sales are anticipated in the range of $265-$290 million compared with the previous expectation of $260-$290 million. Palynziq sales are expected in the range of $230-$260 million compared with the previous range of $220-$260 million. Naglazyme sales are expected between $375-$405 million, unchanged from the previous projection.
Brineura sales are expected within $120-$140 million, which is also unchanged from its previous expectation.
R&D costs are expected in the $635-$675 million band, which was previously expected within $645-$685 million. SG&A expenses are anticipated in the range of $735-$775 million, unchanged from the previous expectation.
The company now expects adjusted net income in the range of $215-$255 million, which was earlier expected in the band of $190-$240 million.
Pipeline Update
In August 2021, the European Commission approved BioMarin’s once-daily injection, Voxzogo (formerly known as vosoritide), to treat achondroplasia, a common form of dwarfism in children from the age of two until after puberty, when they attain final adult height.
The commercial launch of Voxzogo is currently underway and the drug generated sales worth $0.1 million in this brief period of time.
In the United States, the new drug application or NDA for Voxzogo for the treatment of achondroplasia is under priority review with a PDUFA target date of Nov 20, 2021. Marketing authorization for Voxzogo is also under review in Japan, Brazil and Australia, with potential approvals expected in 2022.
We note that BioMarin is developing the investigational gene therapy valoctocogene roxaparvovec for treating adult patients with severe hemophilia A. In July 2021, the European Medicines Agency (“EMA”) validated the marketing authorization application for valoctocogene roxaparvovec, with an opinion from the EMA’s Committee for Medicinal Products for Human Use expected in the first half of 2022.
Last August, the FDA issued a complete response letter to valoctocogene roxaparvovec’s biologics license application (“BLA”). 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. A BLA on the same is expected to be re-filed to the regulatory body in the second quarter of 2022.
This apart, in September 2021, the FDA placed a clinical hold on BioMarin’s phase I/II study — PHEarless — evaluating its AAV5-phenylalanine hydroxylase gene therapy candidate, BMN 307. The study was evaluating ascending doses of the candidate in adult patients with PKU.
BioMarin has temporarily halted enrollment in the study until the investigation is completed. The company is currently working with the FDA and other health authorities to decide a future path for the development of BMN 307 in PKU patients.
BioMarin Pharmaceutical Inc. Price, Consensus and EPS Surprise
Image: Bigstock
BioMarin (BMRN) Beats on Q3 Earnings, Ups 2021 Guidance
BioMarin Pharmaceutical Inc.’s (BMRN - Free Report) third-quarter 2021 adjusted earnings of 18 cents per share beat the Zacks Consensus Estimate of 11 cents. Earnings declined 66.6% year over year on lower net product revenues.
Total revenues were $408.7 million in the reported quarter, down 14% from the year-ago period’s figure. Sales lagged the Zacks Consensus Estimate of $432 million.
Shares of BioMarin have declined 18.2% so far this year compared with the industry’s decrease of 9.6%.
Quarterly Details
Product revenues (including Aldurazyme) were $393.8 million in the quarter, down 14.5% year over year. Product revenues from BioMarin's marketed brands (excluding Aldurazyme) decreased 12.0% year over year to $369.5 million. Royalty and other revenues were $14.9 million in the quarter, down 7.1%.
In the phenylketonuria (“PKU”) franchise, Kuvan revenues declined 45% to $67.7 million due to generic competition as the drug lost U.S. market exclusivity in October 2020. Palynziq injection sales grossed $60.7 million in the quarter, up 32% year over year, driven by the growing number of U.S. patients who have now achieved maintenance dosing as well as new patients initiating therapy.
Naglazyme sales decreased 7% to $71.2 million. Vimizim contributed $136.9 million to total revenues, which went down 7% year over year. Lower sales of both Naglazyme and Vimizim were driven by unfavorable 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 $32.9 million in the quarter, up 30% year over year. Management stated that Brineura maintained a strong patient compliance and continued to grow on strong underlying demand.
Product revenues from Aldurazyme totaled $24.4 million, down 40% 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. During the reported quarter Aldurazyme sales declined due to unfavorable timing of product fulfillment to Genzyme.
R&D expenses increased 6.4% year over year to $133.7 million while SG&A expenses marginally increased 0.8% to $151.3 million.
2021 Guidance
BioMarin raised the lower end of its revenue guidance range for the year. The company now expects total revenues in the range of $1.82-$1.88 billion compared with the earlier projection of $1.79-$1.88 billion. The Zacks Consensus Estimate for the same stands at $1.85 billion.
Vimizim sales are expected in the range of $595-$620 million compared with the previous guidance of $580-$620 million. Kuvan sales are anticipated in the range of $265-$290 million compared with the previous expectation of $260-$290 million. Palynziq sales are expected in the range of $230-$260 million compared with the previous range of $220-$260 million. Naglazyme sales are expected between $375-$405 million, unchanged from the previous projection.
Brineura sales are expected within $120-$140 million, which is also unchanged from its previous expectation.
R&D costs are expected in the $635-$675 million band, which was previously expected within $645-$685 million. SG&A expenses are anticipated in the range of $735-$775 million, unchanged from the previous expectation.
The company now expects adjusted net income in the range of $215-$255 million, which was earlier expected in the band of $190-$240 million.
Pipeline Update
In August 2021, the European Commission approved BioMarin’s once-daily injection, Voxzogo (formerly known as vosoritide), to treat achondroplasia, a common form of dwarfism in children from the age of two until after puberty, when they attain final adult height.
The commercial launch of Voxzogo is currently underway and the drug generated sales worth $0.1 million in this brief period of time.
In the United States, the new drug application or NDA for Voxzogo for the treatment of achondroplasia is under priority review with a PDUFA target date of Nov 20, 2021. Marketing authorization for Voxzogo is also under review in Japan, Brazil and Australia, with potential approvals expected in 2022.
We note that BioMarin is developing the investigational gene therapy valoctocogene roxaparvovec for treating adult patients with severe hemophilia A. In July 2021, the European Medicines Agency (“EMA”) validated the marketing authorization application for valoctocogene roxaparvovec, with an opinion from the EMA’s Committee for Medicinal Products for Human Use expected in the first half of 2022.
Last August, the FDA issued a complete response letter to valoctocogene roxaparvovec’s biologics license application (“BLA”). 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. A BLA on the same is expected to be re-filed to the regulatory body in the second quarter of 2022.
This apart, in September 2021, the FDA placed a clinical hold on BioMarin’s phase I/II study — PHEarless — evaluating its AAV5-phenylalanine hydroxylase gene therapy candidate, BMN 307. The study was evaluating ascending doses of the candidate in adult patients with PKU.
BioMarin has temporarily halted enrollment in the study until the investigation is completed. The company is currently working with the FDA and other health authorities to decide a future path for the development of BMN 307 in PKU patients.
BioMarin Pharmaceutical Inc. Price, Consensus and EPS Surprise
BioMarin Pharmaceutical Inc. price-consensus-eps-surprise-chart | BioMarin Pharmaceutical Inc. Quote
Zacks Rank & Stocks to Consider
BioMarin currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Amicus Therapeutics, Inc. (FOLD - Free Report) and Athenex, Inc. , 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.
Amicus Therapeutics’ loss per share estimates have narrowed 1.3% for 2021 and 37.5% for 2022, over the past 60 days.
Athenex’s loss per share estimates have narrowed 9% for 2021 and 9.2% for 2022, over the past 60 days.