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BioMarin (BMRN) Q4 Earnings Top Estimates, Sales Fall Y/Y
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BioMarin Pharmaceutical Inc. (BMRN - Free Report) reported fourth-quarter 2021 adjusted earnings of 3 cents per share in contrast to the Zacks Consensus Estimate of a loss of 2 cents. Earnings declined 85.7% year over year on lower net product revenues and higher operating costs.
Total revenues were $449.8 million in the reported quarter, down 1% from the year-ago quarter.
BioMarin’s stock was down 1.9% in after-hours trading on Wednesday after the results were announced. In the year so far, the stock price of BioMarin has declined 6.6% compared with the industry’s decline of 9.5%.
Image Source: Zacks Investment Research
Quarterly Details
Product revenues (including Aldurazyme) were $435.9 million in the quarter, almost flat year over year. Product revenues from BioMarin's marketed brands (excluding Aldurazyme) decreased 5% year over year to $414.9 million due to lower Kuvan and Naglazyme revenues. Royalty and other revenues were $14.6 million in the quarter, down 3.2%.
In the phenylketonuria (“PKU”) franchise, Kuvan revenues declined 23% to $68.5 million due to generic competition as the drug lost U.S. market exclusivity in late 2020.
Palynziq injection sales grossed $63.8 million in the quarter, up 29% 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. The number of U.S. patients on commercial Palynziq therapy rose 15% in 2021. However, new patient starts in the United States continued to be hurt by the pandemic impact as PKU clinics were not operating at full capacity.
Vimizim contributed $156.3 million to total revenues, which were up 10% year over year driven by the favorable timing of orders from the Middle East and Latin America. Naglazyme sales decreased 31% to $83.1 million due to the unfavorable timing of orders from the Middle East, Latin America 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 $37.4 million in the quarter, up 7% year over year due to continued growth in EMEA and North America. Patients on commercial Brineura therapy increased 18%, which reflects strong underlying demand trends that the product enjoys.
The new drug Voxzogo, to treat achondroplasia, was approved in the United States in November and in Europe in August 2021. The drug generated sales worth $5.8 million in the fourth quarter with the vast majority of sales coming from Europe. On the conference call, BioMarin management said that Voxzogo’s global launch is on a strong trajectory with the drug witnessing robust early prescription demand.
Product revenues from Aldurazyme totaled $20.3 million compared with $1.2 million in the year-ago quarter 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. Genzyme is BioMarin's sole customer for Aldurazyme and is responsible for marketing and selling Aldurazyme to third parties.
Full-Year Results
Full-year total revenues declined 1% to $1.85 billion. Adjusted earnings were $1.33 per share in 2021 compared with $1.63 per share in 2020.
Pipeline Update
Along with the earnings release, BioMarin announced a top-line update from a phase II study on Voxzogo in infants and young children up to five years of age with achondroplasia. The 52-week results trended in favor of Voxzogo compared to placebo on height Z-score (which measures height adjusted for age and sex), annualized growth velocity and no worsening of proportionality in the overall study population. Based on this data, BioMarin will initiate regulatory discussions to expand Voxzogo’s label to allow its use in this age group.
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 and the marketing authorization application (MAA) in Europe was withdrawn. BioMarin resubmitted the MAA along with this one-year data to the 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 European Medicines Agency (EMA). A BLA is expected to be re-filed to the FDA in the second quarter of 2022.
Another important pipeline candidate is the gene therapy PKU candidate, BMN 307. In September 2021, the FDA placed a clinical hold on BioMarin’s phase I/II study — PHEarless — on BMN 307 based on the interim preclinical data, which showed that some mice developed liver malignancy. Earlier this month, BioMarin received a request from the FDA to submit data from additional non-clinical studies to assess the theoretical oncogenic risk to human study participants, in order to resolve the clinical hold of the PHEARLESS. BioMarin believes this data will take several quarters to be available.
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 now open for enrolment.
2022 Guidance
BioMarin expects to return to double-digit revenue growth and profitability in 2022.
BioMarin expects total revenues in the range of $2.05-$2.15 billion, which indicates growth of 14% at the mid-point. The Zacks Consensus Estimate stands at $2.09 billion. BioMarin expects Voxzogo to contribute significantly to 2022 revenues. BioMarin expects Roctavian to be a modest contributor to 2022 revenues.
Vimizim sales are expected in the range of $650-$700 million in 2022. Kuvan sales are anticipated in the range of $225-$250 million. Palynziq sales are expected in the range of $280-$310 million. Naglazyme sales are expected between $400 million and $440 million. Brineura sales are expected within $145-$160 million. Voxzogo sales are expected to be between $90 million and $115 million.
The company expects adjusted net income in the range of $350-$390 million, indicating more than 50% growth from 2021.
Vertex Pharmaceuticals’ stock has risen 5.1% this year so far. Estimates for Vertex Pharmaceuticals’ 2022 earnings have gone up from $13.32 to $14.33 per share while those for 2023 have increased from $13.85 to $15.31 per share over the past 60 days.
Vertex Pharmaceuticals’ earnings performance has been strong with the company beating earnings expectations in each of the last four quarters. Vertex Pharmaceuticals has a four-quarter earnings surprise of 10.01%, on average.
Estimates for Gamida Cell’s 2022 bottom line have narrowed from a loss of $1.83 to $1.35 per share in the past 60 days. Gamida Cell’s stock is up 20.1% this year so far.
Gamida Cell beat estimates in two of the last four quarters while missing in the other two with the average negative surprise being 22.6%.
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BioMarin (BMRN) Q4 Earnings Top Estimates, Sales Fall Y/Y
BioMarin Pharmaceutical Inc. (BMRN - Free Report) reported fourth-quarter 2021 adjusted earnings of 3 cents per share in contrast to the Zacks Consensus Estimate of a loss of 2 cents. Earnings declined 85.7% year over year on lower net product revenues and higher operating costs.
Total revenues were $449.8 million in the reported quarter, down 1% from the year-ago quarter.
BioMarin’s stock was down 1.9% in after-hours trading on Wednesday after the results were announced. In the year so far, the stock price of BioMarin has declined 6.6% compared with the industry’s decline of 9.5%.
Image Source: Zacks Investment Research
Quarterly Details
Product revenues (including Aldurazyme) were $435.9 million in the quarter, almost flat year over year. Product revenues from BioMarin's marketed brands (excluding Aldurazyme) decreased 5% year over year to $414.9 million due to lower Kuvan and Naglazyme revenues. Royalty and other revenues were $14.6 million in the quarter, down 3.2%.
In the phenylketonuria (“PKU”) franchise, Kuvan revenues declined 23% to $68.5 million due to generic competition as the drug lost U.S. market exclusivity in late 2020.
Palynziq injection sales grossed $63.8 million in the quarter, up 29% 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. The number of U.S. patients on commercial Palynziq therapy rose 15% in 2021. However, new patient starts in the United States continued to be hurt by the pandemic impact as PKU clinics were not operating at full capacity.
Vimizim contributed $156.3 million to total revenues, which were up 10% year over year driven by the favorable timing of orders from the Middle East and Latin America. Naglazyme sales decreased 31% to $83.1 million due to the unfavorable timing of orders from the Middle East, Latin America 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 $37.4 million in the quarter, up 7% year over year due to continued growth in EMEA and North America. Patients on commercial Brineura therapy increased 18%, which reflects strong underlying demand trends that the product enjoys.
The new drug Voxzogo, to treat achondroplasia, was approved in the United States in November and in Europe in August 2021. The drug generated sales worth $5.8 million in the fourth quarter with the vast majority of sales coming from Europe. On the conference call, BioMarin management said that Voxzogo’s global launch is on a strong trajectory with the drug witnessing robust early prescription demand.
Product revenues from Aldurazyme totaled $20.3 million compared with $1.2 million in the year-ago quarter 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. Genzyme is BioMarin's sole customer for Aldurazyme and is responsible for marketing and selling Aldurazyme to third parties.
Full-Year Results
Full-year total revenues declined 1% to $1.85 billion. Adjusted earnings were $1.33 per share in 2021 compared with $1.63 per share in 2020.
Pipeline Update
Along with the earnings release, BioMarin announced a top-line update from a phase II study on Voxzogo in infants and young children up to five years of age with achondroplasia. The 52-week results trended in favor of Voxzogo compared to placebo on height Z-score (which measures height adjusted for age and sex), annualized growth velocity and no worsening of proportionality in the overall study population. Based on this data, BioMarin will initiate regulatory discussions to expand Voxzogo’s label to allow its use in this age group.
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 and the marketing authorization application (MAA) in Europe was withdrawn. BioMarin resubmitted the MAA along with this one-year data to the 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 European Medicines Agency (EMA). A BLA is expected to be re-filed to the FDA in the second quarter of 2022.
Another important pipeline candidate is the gene therapy PKU candidate, BMN 307. In September 2021, the FDA placed a clinical hold on BioMarin’s phase I/II study — PHEarless — on BMN 307 based on the interim preclinical data, which showed that some mice developed liver malignancy. Earlier this month, BioMarin received a request from the FDA to submit data from additional non-clinical studies to assess the theoretical oncogenic risk to human study participants, in order to resolve the clinical hold of the PHEARLESS. BioMarin believes this data will take several quarters to be available.
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 now open for enrolment.
2022 Guidance
BioMarin expects to return to double-digit revenue growth and profitability in 2022.
BioMarin expects total revenues in the range of $2.05-$2.15 billion, which indicates growth of 14% at the mid-point. The Zacks Consensus Estimate stands at $2.09 billion. BioMarin expects Voxzogo to contribute significantly to 2022 revenues. BioMarin expects Roctavian to be a modest contributor to 2022 revenues.
Vimizim sales are expected in the range of $650-$700 million in 2022. Kuvan sales are anticipated in the range of $225-$250 million. Palynziq sales are expected in the range of $280-$310 million. Naglazyme sales are expected between $400 million and $440 million. Brineura sales are expected within $145-$160 million. Voxzogo sales are expected to be between $90 million and $115 million.
The company expects adjusted net income in the range of $350-$390 million, indicating more than 50% growth from 2021.
Zacks Rank & Stocks to Consider
BioMarin currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
BioMarin Pharmaceutical Inc. Price, Consensus and EPS Surprise
BioMarin Pharmaceutical Inc. price-consensus-eps-surprise-chart | BioMarin Pharmaceutical Inc. Quote
Some better-ranked stocks in the drug/biotech sector include Vertex Pharmaceuticals (VRTX - Free Report) and Gamida Cell , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Vertex Pharmaceuticals’ stock has risen 5.1% this year so far. Estimates for Vertex Pharmaceuticals’ 2022 earnings have gone up from $13.32 to $14.33 per share while those for 2023 have increased from $13.85 to $15.31 per share over the past 60 days.
Vertex Pharmaceuticals’ earnings performance has been strong with the company beating earnings expectations in each of the last four quarters. Vertex Pharmaceuticals has a four-quarter earnings surprise of 10.01%, on average.
Estimates for Gamida Cell’s 2022 bottom line have narrowed from a loss of $1.83 to $1.35 per share in the past 60 days. Gamida Cell’s stock is up 20.1% this year so far.
Gamida Cell beat estimates in two of the last four quarters while missing in the other two with the average negative surprise being 22.6%.