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BioMarin (BMRN) Q3 Loss Narrows Y/Y, Pipeline in Focus
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BioMarin Pharmaceutical Inc. (BMRN - Free Report) reported a loss of 18 cents per share in the third quarter of 2016 (including stock-based compensation expense), narrower than the year-ago loss of 44 cents. The Zacks Consensus Estimate was of a loss of 39 cents per share.
Total revenue came in at approximately $280 million in the quarter, up 34% from the year-ago quarter. The top line was aided by strong net product sales. However, revenues were short of the Zacks Consensus Estimate of $289.1 million.
Quarterly Details
Vimizim contributed $81 million to total revenue, up 25% year over year. However, sequentially it was down 24.2% due to significant forward purchases in Latin America and the Middle East in second-quarter 2016, which were not repeated in the third quarter.
Kuvan revenues soared 42% to $91 million, reflecting contribution from North America and the newly acquired ex-North American territories.
Naglazyme sales surged 44% year over year to $78 million, mainly due to the timing of central government orders from Latin America.
BioMarin received Aldurazyme royalties – totalling $24 million (up 14%) – from Sanofi’s (SNY - Free Report) Genzyme.
Meanwhile, Firdapse revenues remained flat year over year at $4 million.
Research and development (R&D) expenses grew 1.3% to $160.8 million while selling, general and administrative (SG&A) expenses increased 26.3 % to $118.8 million.
2016 Outlook
BioMarin maintained its total revenue outlook for 2016. The company continues to expect total revenue in the range of $1.10−$1.15 billion. However, it anticipates total revenue at the lower end of the projected range due to political and economic instability in Brazil and the Middle East.
Vimizim sales are still expected in the range of $340–$360 million while Kuvan sales are projected in the range of $340−$360 million. However, economic and political conditions in Brazil and Turkey have led the company to forecast Naglazyme sales at the lower end of the previously projected range of $290−$320 million.
However, R&D expenses are now expected in the $650–$670 million range (old guidance: $670–$690 million) while SG&A expenses are now projected in the $460–$480 million range (old guidance: $470–$490 million).
The company now expects loss of $10−$30 million (old guidance: loss in the range of $30−$50 million) due to continued strong top-line growth and operating expense discipline.
Pipeline Update
During the reported quarter, BioMarin received a regulatory setback in the form of an extension of the review period for Brineura by three months following the submission of additional data from an ongoing extension study, per the FDA’s request. The regulatory agency will announce its decision on Apr 27, 2017, instead of the previous date of Jan 27, 2017. Brineura was accepted for review in the EU, where a decision should be out in the third quarter of 2017. The company is looking to get Brineura approved for the treatment of children with CLN2 disease, which is a form of Batten disease.
Meanwhile, BioMarin remains on track to initiate a phase III study on vosoritide in children with achondroplasia by year end. The company plans to submit a regulatory application to the FDA for pegvaliase for the treatment of phenylketonuria in the first quarter of 2017.
Incyte’s earnings estimates for 2016 and 2017 were up a respective 10% and 2.1% over the last 60 days. The company has beaten earnings estimates thrice in the last four quarters with an average surprise of 335.16%.
Exelixis has an average positive surprise of 9.10% over the trailing four quarters. Its share price has jumped more than 90% year to date. The loss estimates for both 2016 and 2017 have narrowed over the past 60 days.
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BioMarin (BMRN) Q3 Loss Narrows Y/Y, Pipeline in Focus
BioMarin Pharmaceutical Inc. (BMRN - Free Report) reported a loss of 18 cents per share in the third quarter of 2016 (including stock-based compensation expense), narrower than the year-ago loss of 44 cents. The Zacks Consensus Estimate was of a loss of 39 cents per share.
Total revenue came in at approximately $280 million in the quarter, up 34% from the year-ago quarter. The top line was aided by strong net product sales. However, revenues were short of the Zacks Consensus Estimate of $289.1 million.
Quarterly Details
Vimizim contributed $81 million to total revenue, up 25% year over year. However, sequentially it was down 24.2% due to significant forward purchases in Latin America and the Middle East in second-quarter 2016, which were not repeated in the third quarter.
Kuvan revenues soared 42% to $91 million, reflecting contribution from North America and the newly acquired ex-North American territories.
Naglazyme sales surged 44% year over year to $78 million, mainly due to the timing of central government orders from Latin America.
BioMarin received Aldurazyme royalties – totalling $24 million (up 14%) – from Sanofi’s (SNY - Free Report) Genzyme.
Meanwhile, Firdapse revenues remained flat year over year at $4 million.
Research and development (R&D) expenses grew 1.3% to $160.8 million while selling, general and administrative (SG&A) expenses increased 26.3 % to $118.8 million.
2016 Outlook
BioMarin maintained its total revenue outlook for 2016. The company continues to expect total revenue in the range of $1.10−$1.15 billion. However, it anticipates total revenue at the lower end of the projected range due to political and economic instability in Brazil and the Middle East.
Vimizim sales are still expected in the range of $340–$360 million while Kuvan sales are projected in the range of $340−$360 million. However, economic and political conditions in Brazil and Turkey have led the company to forecast Naglazyme sales at the lower end of the previously projected range of $290−$320 million.
However, R&D expenses are now expected in the $650–$670 million range (old guidance: $670–$690 million) while SG&A expenses are now projected in the $460–$480 million range (old guidance: $470–$490 million).
The company now expects loss of $10−$30 million (old guidance: loss in the range of $30−$50 million) due to continued strong top-line growth and operating expense discipline.
Pipeline Update
During the reported quarter, BioMarin received a regulatory setback in the form of an extension of the review period for Brineura by three months following the submission of additional data from an ongoing extension study, per the FDA’s request. The regulatory agency will announce its decision on Apr 27, 2017, instead of the previous date of Jan 27, 2017. Brineura was accepted for review in the EU, where a decision should be out in the third quarter of 2017. The company is looking to get Brineura approved for the treatment of children with CLN2 disease, which is a form of Batten disease.
Meanwhile, BioMarin remains on track to initiate a phase III study on vosoritide in children with achondroplasia by year end. The company plans to submit a regulatory application to the FDA for pegvaliase for the treatment of phenylketonuria in the first quarter of 2017.
BIOMARIN PHARMA Price, Consensus and EPS Surprise
BIOMARIN PHARMA Price, Consensus and EPS Surprise | BIOMARIN PHARMA Quote
Zacks Rank & Key Picks
BioMarin currently sports a Zacks Rank #1 (Strong Buy). A couple of favorably placed stocks in the health care sector are Exelixis, Inc. (EXEL - Free Report) and Incyte Corporation (INCY - Free Report) . Both the stocks carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Incyte’s earnings estimates for 2016 and 2017 were up a respective 10% and 2.1% over the last 60 days. The company has beaten earnings estimates thrice in the last four quarters with an average surprise of 335.16%.
Exelixis has an average positive surprise of 9.10% over the trailing four quarters. Its share price has jumped more than 90% year to date. The loss estimates for both 2016 and 2017 have narrowed over the past 60 days.
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>