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BioMarin (BMRN) Posts Earnings in Q1, Sales Top, Stock Up
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BioMarin Pharmaceutical Inc. (BMRN - Free Report) reported earnings of 3 cents per share in the first quarter of 2017 (including stock-based compensation expense), significantly better than the year-ago loss of 36 cents and the Zacks Consensus Estimate of a loss of 30 cents per share. Higher gross margins from net product sales and lower R&D costs pulled up profits in the quarter.
Total revenue came in at $304 million in the quarter, up 28% from the year-ago quarter. The top line was aided by strong net product sales. Revenues also beat the Zacks Consensus Estimate of $292 million by 3.9%
Shares of BioMarin were up more than 2% in after-market hours on Thursday in response to the strong financial results. In fact, so far this year, BioMarin’s shares are up 18.1%, which compares favorably with an increase of 4.7% registered by the Zacks classified Biomed/Genetics industry during this period.
Quarterly Details
Vimizim contributed $106 million to total revenue, up 45% year over year and 13% sequentially attributable to 31% growth in new patients on Vimizim therapy.
The company expects continued growth in 2017 as the franchise continues to benefit from robust underlying patient demand.
Kuvan revenues rose 19% to $92 million, reflecting patient growth in North America and the addition of new patients in the international markets.
Naglazyme sales rose 25% year over year to $81 million. Naglazyme revenues vary on a quarterly basis, primarily due to the timing of central government orders from Latin America. Nevertheless, the drug continued to witness steady patient growth with the number of commercial patients increasing 9% in the quarter.
BioMarin received Aldurazyme royalties – totaling $19 million (up 19%) – from Sanofi’s (SNY - Free Report) Genzyme in the quarter.
Research and development (R&D) expenses declined 8.6% to $127.0 million (excluding stock-based compensation expense) owning to the discontinuance of the Kyndrisa and reveglucosidase alfa programs last year. Selling, general and administrative (SG&A) expenses increased 15.5% to $97.0 million (excluding stock-based compensation expense).
Other Updates
Last month, BioMarin announced that it has received approval from the FDA for Brineura for the treatment of children with CLN2 disease, which is a form of Batten disease. With this approval, Brineura is now the first approved treatment for children with CLN2. The company has begun the commercial launch of Brineura in the U.S.
Brineura is also under review in the EU, where a decision should be out by the second quarter of 2017. Last month, BioMarin received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending approval of Brineura in EU.
Last month, BioMarin entered into a settlement agreement with Par Pharmaceutical, subsidiary of Endo International plc related to a patent infringement lawsuit for Kuvan (tablets and powder). With this agreement, Kuvan should not face generic competition from Par until Oct 1, 2020. The company had earlier entered into a settlement agreement with Dr. Reddy's Laboratories Limited (RDY - Free Report) for Kuvan tablets in Sep 2015. The settlement agreement removes an overhang on the shares.
BioMarin has a robust pipeline with several data readouts lined up for the coming quarters. The most important candidate in its pipeline is vosoritide, which is currently in a phase III study for the treatment of children with achondroplasia, the most common form of dwarfism. This will be followed by an open-label extension study with the lower dose (15 µg/kg/day). In addition, BioMarin is planning a separate phase II study to evaluate the effect of vosoritide in infants and toddlers.
The company plans to submit a regulatory application to the FDA for another important pipeline candidate, pegvaliase for the treatment of phenylketonuria in the second quarter of 2017.
2017 Outlook Re-Affirmed
The company re-affirmed its previously issued 2017 sales and earnings guidance.
BioMarin expects total revenue in the range of $1.25 −$1.30 billion, representing double-digit revenue growth. The revenue guidance assumes the launch of Brineura in 2017. Vimizim sales are expected in the range of $400–$430 million while Kuvan sales are projected in the range of $380−$410 million, representing an increase of about 14% over 2016 at the mid-point. Naglazyme sales are projected in the range of $300−$330 million.
R&D expenses are expected within $620–$650 million while SG&A expenses are projected in the range of $520–$550 million.
Adjusted earnings are expected to turn positive. The company expects adjusted net income of $30 - $70 million in 2017. Meanwhile, management committed to continued profitability improvements over the longer term.
BioMarin Pharmaceutical Inc. Price, Consensus and EPS Surprise
More Stock News: 8 Companies Verge on Apple-Like Run
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Now 2017 looks to be a pivotal year to get in on another emerging technology expected to rock the market. Demand could soar from almost nothing to $42 billion by 2025. Reports suggest it could save 10 million lives per decade which could in turn save $200 billion in U.S. healthcare costs.
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BioMarin (BMRN) Posts Earnings in Q1, Sales Top, Stock Up
BioMarin Pharmaceutical Inc. (BMRN - Free Report) reported earnings of 3 cents per share in the first quarter of 2017 (including stock-based compensation expense), significantly better than the year-ago loss of 36 cents and the Zacks Consensus Estimate of a loss of 30 cents per share. Higher gross margins from net product sales and lower R&D costs pulled up profits in the quarter.
Total revenue came in at $304 million in the quarter, up 28% from the year-ago quarter. The top line was aided by strong net product sales. Revenues also beat the Zacks Consensus Estimate of $292 million by 3.9%
Shares of BioMarin were up more than 2% in after-market hours on Thursday in response to the strong financial results. In fact, so far this year, BioMarin’s shares are up 18.1%, which compares favorably with an increase of 4.7% registered by the Zacks classified Biomed/Genetics industry during this period.
Quarterly Details
Vimizim contributed $106 million to total revenue, up 45% year over year and 13% sequentially attributable to 31% growth in new patients on Vimizim therapy.
The company expects continued growth in 2017 as the franchise continues to benefit from robust underlying patient demand.
Kuvan revenues rose 19% to $92 million, reflecting patient growth in North America and the addition of new patients in the international markets.
Naglazyme sales rose 25% year over year to $81 million. Naglazyme revenues vary on a quarterly basis, primarily due to the timing of central government orders from Latin America. Nevertheless, the drug continued to witness steady patient growth with the number of commercial patients increasing 9% in the quarter.
BioMarin received Aldurazyme royalties – totaling $19 million (up 19%) – from Sanofi’s (SNY - Free Report) Genzyme in the quarter.
Research and development (R&D) expenses declined 8.6% to $127.0 million (excluding stock-based compensation expense) owning to the discontinuance of the Kyndrisa and reveglucosidase alfa programs last year. Selling, general and administrative (SG&A) expenses increased 15.5% to $97.0 million (excluding stock-based compensation expense).
Other Updates
Last month, BioMarin announced that it has received approval from the FDA for Brineura for the treatment of children with CLN2 disease, which is a form of Batten disease. With this approval, Brineura is now the first approved treatment for children with CLN2. The company has begun the commercial launch of Brineura in the U.S.
Brineura is also under review in the EU, where a decision should be out by the second quarter of 2017. Last month, BioMarin received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending approval of Brineura in EU.
Last month, BioMarin entered into a settlement agreement with Par Pharmaceutical, subsidiary of Endo International plc related to a patent infringement lawsuit for Kuvan (tablets and powder). With this agreement, Kuvan should not face generic competition from Par until Oct 1, 2020. The company had earlier entered into a settlement agreement with Dr. Reddy's Laboratories Limited (RDY - Free Report) for Kuvan tablets in Sep 2015. The settlement agreement removes an overhang on the shares.
BioMarin has a robust pipeline with several data readouts lined up for the coming quarters. The most important candidate in its pipeline is vosoritide, which is currently in a phase III study for the treatment of children with achondroplasia, the most common form of dwarfism. This will be followed by an open-label extension study with the lower dose (15 µg/kg/day). In addition, BioMarin is planning a separate phase II study to evaluate the effect of vosoritide in infants and toddlers.
The company plans to submit a regulatory application to the FDA for another important pipeline candidate, pegvaliase for the treatment of phenylketonuria in the second quarter of 2017.
2017 Outlook Re-Affirmed
The company re-affirmed its previously issued 2017 sales and earnings guidance.
BioMarin expects total revenue in the range of $1.25 −$1.30 billion, representing double-digit revenue growth. The revenue guidance assumes the launch of Brineura in 2017. Vimizim sales are expected in the range of $400–$430 million while Kuvan sales are projected in the range of $380−$410 million, representing an increase of about 14% over 2016 at the mid-point. Naglazyme sales are projected in the range of $300−$330 million.
R&D expenses are expected within $620–$650 million while SG&A expenses are projected in the range of $520–$550 million.
Adjusted earnings are expected to turn positive. The company expects adjusted net income of $30 - $70 million in 2017. Meanwhile, management committed to continued profitability improvements over the longer term.
BioMarin Pharmaceutical Inc. Price, Consensus and EPS Surprise
BioMarin Pharmaceutical Inc. Price, Consensus and EPS Surprise | BioMarin Pharmaceutical Inc. Quote
BioMarin sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
More Stock News: 8 Companies Verge on Apple-Like Run
Did you miss Apple's 9X stock explosion after they launched their iPhone in 2007?
Now 2017 looks to be a pivotal year to get in on another emerging technology expected to rock the market. Demand could soar from almost nothing to $42 billion by 2025. Reports suggest it could save 10 million lives per decade which could in turn save $200 billion in U.S. healthcare costs.
A bonus Zacks Special Report names this breakthrough and the 8 best stocks to exploit it. Like Apple in 2007, these companies are already strong and coiling for potential mega-gains. Click to see them right now >>