BioMarin Pharmaceutical Inc. ( BMRN Quick Quote BMRN - Free Report) reported first-quarter 2022 adjusted earnings of 55 cents per share, beating the Zacks Consensus Estimate of 38 cents. However, earnings slid 1.8% from the year-ago quarter’s figure.
Total revenues were $519.4 million in the reported quarter, up 7% from the year-ago quarter’s level. The revenues beat the Zacks Consensus Estimate of $505 million.
Quarter in Detail
Product revenues (including Aldurazyme) were $505.5 million in the quarter, up 8.1% year over year. Product revenues from BioMarin's marketed brands (excluding Aldurazyme) were up 15% year over year to $481.1 million on higher revenues from Vimzim, Naglazyme, Voxzogo and Brineura. Royalty and other revenues were $13.8 million in the quarter, down 24.2%.
Vimizim sales were up 16% year over year to $183 million while Naglazyme sales were up 19% to $128 million. The rise in sales was driven by the new patients initiating therapy as well as the favorable timing of orders in the Middle East and Europe. On the conference call, management said that both Naglazyme and Vimzim achieved record quarterly sales in first-quarter 2022.
Brineura generated sales of $36.2 million in the quarter, up 33% year over year, driven by 18% growth in new patients starting treatment in Europe.
The new drug Voxzogo, approved last year in United Sates and Europe to treat achondroplasia, generated sales worth $19.7 million in the first quarter with the majority of sales coming from Europe. During the previous quarter, the drug generated $5.2 million of revenues. Per management, an estimated 284 children are being treated with Voxzogo, of which 83 reside in the United States.
Palynziq injection sales grossed $54.9 million in the quarter, up 2% year over year. Sales continued to be hurt by the pandemic impact as PKU clinics were not operating at full capacity.
In the phenylketonuria (PKU) franchise, Kuvan revenues declined 16% to $59.3 million due to generic competition as the drug lost U.S. market exclusivity in late 2020.
Product revenues from Aldurazyme totaled $24.4 million, down 51% due to the unfavorable timing of product fulfillment to
Sanofi’s ( SNY Quick Quote SNY - Free Report) subsidiary Genzyme.
BioMarin has a collaboration agreement with Sanofi’s Genzyme for Aldurazyme. SNY through Genzyme is BioMarin's sole customer for Aldurazyme and is responsible for marketing and selling Aldurazyme to third parties.
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. A BLA is expected to be re-filed with the FDA later this year in June. BMRN scheduled a pre-submission interaction with the regulatory agency during the second quarter to discuss its resubmission efforts.
In first-quarter 2022, BioMarin announced that a study participant who was treated in a phase II study evaluating Roctavian in 2016 had reported a salivary gland tumor. Alongside its first quarter earnings, BMRN announced that it had completed a genomic analysis of the tissue sample from the tumor mass, which did not show any evidence of vector integration contributing to the tumor. BMRN already submitted this information to the EMA.
An important candidate in BioMarin’s pipeline is BMN 307, an investigational gene-therapy for PKU. Its phase I/II PHEarless study has beenplaced under clinical hold by the FDA since September 2021. In February 2022, BMRN reported that it received a request from the regulatory body to submit data from additional non-clinical studies to assess the theoretical oncogenic risk to human study participants to resolve the clinical hold. Management believes that 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 Revision
BioMarin now expects to record Voxzogo sales in the range of $100-$125 million in 2022, up from the previously affirmed guidance of $90-$115 million. On the conference call, management said that it expects Voxzogo to be a meaningful contributor to BMRN’s total revenues. BMRN expects robust prescription demand to continue driving the drug’s growth, including approval in the new markets.
Shares of BioMarin were up 3.4% in after-hours trading on Wednesday as investors were most likely impressed with the raised financial guidance for 2022 revenues from Voxzogo. In the year so far, the stock has declined 9.1% compared with the
industry’s fall of 20%. Image Source: Zacks Investment Research
Apart from Voxzogo sales, BioMarin maintained its previously issued guidance for 2022. BMRN reiterated total 2022 revenues in the range of $2.05-$2.15 billion, indicating growth of 14% at the midpoint.
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. BioMarin expects Roctavian to be a modest contributor to its current-year revenues.
BioMarin expects adjusted net income in the range of $350-$390 million, indicating more than 50% growth from the 2021 actuals.
Zacks Rank & Other Stocks to Consider
Currently, BioMarin sports a Zacks Rank #1 (Strong Buy). Other top-ranked stocks in the same sector include
Deciphera Pharmaceuticals ( DCPH Quick Quote DCPH - Free Report) and Vertex Pharmaceuticals ( VRTX Quick Quote VRTX - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see . the complete list of today’s Zacks #1 Rank stocks here
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