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Ultragenyx (RARE) Posts Narrower-Than-Expected Loss in Q4
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Ultragenyx Pharmaceutical (RARE - Free Report) reported loss per share of $1.73 in the fourth quarter of 2018, which was narrower than the loss of $1.89 in the year-ago quarter. Loss was also narrower than the Zacks Consensus Estimate of a loss of $1.74.
For the fourth quarter, Ultragenyx reported $16.3 million in total revenues, down from $2.4 million in the year-ago quarter. Revenues beat the Zacks Consensus Estimate of $13 million.
Total revenues included $9.9 million from collaboration revenues in the U.S. profit share territory. It also includes $1.6 million received from Bayer (BAYRY - Free Report) in relation to Ultragenyx’s research agreement with the former to develop adeno-associated virus gene therapies. Ultragenyx recognized $1.3 million in profit sharing and royalty revenues from Japanese collaboration partner, Kyowa Hakko Kirin, for Crysvita. Net product sales for Crysvita in other regions were $0.4 million. Mepsevii product revenues were $2.7 million and UX007 revenues were $0.5 million.
Please note that though UX007 is not an approved product, the company recognizes sales from the candidate on a “named patient” basis. This is allowed in certain countries, prior to the commercial approval of a product.
We remind investors that the FDA approved Crysvita in April for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients aged one year or older. Further, Mepsevii, an enzyme replacement therapy, is the first and the only medicine approved for the treatment of children and adults with mucopolysaccharidosis VII (MPS VII) in the United States.
Shares of Ultragenyx have rallied 17.9% in the past year, against the industry’s decline of 15.2%.
2018 Results
For 2018, the company reported a loss of $3.97 per share, narrower than the year-ago loss of $7.12.
Revenues were $51.5 million in 2018 compared with $2.6 million in 2017.
Pipeline Updates
The company released longer-term data from the phase III pediatric study of Crysvita for the treatment of XLH. The study showed superior efficacy of Crysvita compared with conventional oral phosphate treatment. Crysvita was approved and launched in Canada for the treatment of XLH in adults and pediatric patients aged one year or older. Canada is included in the North American profit share agreement with the company’s partner Kyowa Hakka Kirin.
The company reported positive top-line data from ongoing long-term extension study of UX007 for the treatment of long-chain fatty acid oxidation disorders (LC-FAOD), which showedsustained reductions in the duration and frequency of major clinical events (MCEs), primarily hospitalizations for hypoglycemia, cardiomyopathy and rhabdomyolysis. Ultragenyx is on track to submit a new drug application (NDA) to the FDA for UX007to treat LC-FAODin mid-2019.
During the fourth quarter, the company announced positive top-line results from the first cohort of the phase I/II clinical study of DTX401 gene therapy in Glycogen Storage Disease Type Ia(GSDIa). Enrollment is ongoing in the second-dose cohort of the phase I/II study inGSDIa. Cohort 2 data are expected in mid-2019.
Enrollment is ongoing in the third-dose cohort of the phase I/II study ofDTX301gene therapy in Ornithine Transcarbamylase (OTC) deficiency. Cohort 3 data are expected in mid-2019.
Our Take
The company reported narrower-than-expected loss and sales beat estimates in the fourth quarter of 2018. In 2019, the company looks forward to expand the global commercial reach of its approved therapies, submit an NDA for UX007 and advance its gene-therapy platform toward pivotal studies.
Ultragenyx Pharmaceutical Inc. Price, Consensus and EPS Surprise
Ultragenyx currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks are Celgene Corporation and BioDelivery Sciences International, Inc. . Both the stocks carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Celgene’s earnings per share estimates have increased from $10.21 to $10.69 for 2019 and from $11.61 to $12.62 for 2020 in the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters, with average of 2.65%.
BioDelivery Sciences’ loss per share estimates have narrowed from 25 cents to 22 cents for 2019 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with average of 8.57%.
Zacks' Top 10 Stocks for 2019
In addition to the stocks discussed above, would you like to know about our 10 finest buy-and-holds for the year?
Who wouldn't? Our annual Top 10s have beaten the market with amazing regularity. In 2018, while the market dropped -5.2%, the portfolio scored well into double-digits overall with individual stocks rising as high as +61.5%. And from 2012-2017, while the market boomed +126.3, Zacks' Top 10s reached an even more sensational +181.9%.
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Ultragenyx (RARE) Posts Narrower-Than-Expected Loss in Q4
Ultragenyx Pharmaceutical (RARE - Free Report) reported loss per share of $1.73 in the fourth quarter of 2018, which was narrower than the loss of $1.89 in the year-ago quarter. Loss was also narrower than the Zacks Consensus Estimate of a loss of $1.74.
For the fourth quarter, Ultragenyx reported $16.3 million in total revenues, down from $2.4 million in the year-ago quarter. Revenues beat the Zacks Consensus Estimate of $13 million.
Total revenues included $9.9 million from collaboration revenues in the U.S. profit share territory. It also includes $1.6 million received from Bayer (BAYRY - Free Report) in relation to Ultragenyx’s research agreement with the former to develop adeno-associated virus gene therapies. Ultragenyx recognized $1.3 million in profit sharing and royalty revenues from Japanese collaboration partner, Kyowa Hakko Kirin, for Crysvita. Net product sales for Crysvita in other regions were $0.4 million. Mepsevii product revenues were $2.7 million and UX007 revenues were $0.5 million.
Please note that though UX007 is not an approved product, the company recognizes sales from the candidate on a “named patient” basis. This is allowed in certain countries, prior to the commercial approval of a product.
We remind investors that the FDA approved Crysvita in April for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients aged one year or older. Further, Mepsevii, an enzyme replacement therapy, is the first and the only medicine approved for the treatment of children and adults with mucopolysaccharidosis VII (MPS VII) in the United States.
Shares of Ultragenyx have rallied 17.9% in the past year, against the industry’s decline of 15.2%.
2018 Results
For 2018, the company reported a loss of $3.97 per share, narrower than the year-ago loss of $7.12.
Revenues were $51.5 million in 2018 compared with $2.6 million in 2017.
Pipeline Updates
The company released longer-term data from the phase III pediatric study of Crysvita for the treatment of XLH. The study showed superior efficacy of Crysvita compared with conventional oral phosphate treatment. Crysvita was approved and launched in Canada for the treatment of XLH in adults and pediatric patients aged one year or older. Canada is included in the North American profit share agreement with the company’s partner Kyowa Hakka Kirin.
The company reported positive top-line data from ongoing long-term extension study of UX007 for the treatment of long-chain fatty acid oxidation disorders (LC-FAOD), which showed sustained reductions in the duration and frequency of major clinical events (MCEs), primarily hospitalizations for hypoglycemia, cardiomyopathy and rhabdomyolysis. Ultragenyx is on track to submit a new drug application (NDA) to the FDA for UX007 to treat LC-FAOD in mid-2019.
During the fourth quarter, the company announced positive top-line results from the first cohort of the phase I/II clinical study of DTX401 gene therapy in Glycogen Storage Disease Type Ia (GSDIa). Enrollment is ongoing in the second-dose cohort of the phase I/II study in GSDIa. Cohort 2 data are expected in mid-2019.
Enrollment is ongoing in the third-dose cohort of the phase I/II study of DTX301 gene therapy in Ornithine Transcarbamylase (OTC) deficiency. Cohort 3 data are expected in mid-2019.
Our Take
The company reported narrower-than-expected loss and sales beat estimates in the fourth quarter of 2018. In 2019, the company looks forward to expand the global commercial reach of its approved therapies, submit an NDA for UX007 and advance its gene-therapy platform toward pivotal studies.
Ultragenyx Pharmaceutical Inc. Price, Consensus and EPS Surprise
Ultragenyx Pharmaceutical Inc. Price, Consensus and EPS Surprise | Ultragenyx Pharmaceutical Inc. Quote
Zacks Rank and Stocks to Consider
Ultragenyx currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks are Celgene Corporation and BioDelivery Sciences International, Inc. . Both the stocks carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Celgene’s earnings per share estimates have increased from $10.21 to $10.69 for 2019 and from $11.61 to $12.62 for 2020 in the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters, with average of 2.65%.
BioDelivery Sciences’ loss per share estimates have narrowed from 25 cents to 22 cents for 2019 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with average of 8.57%.
Zacks' Top 10 Stocks for 2019
In addition to the stocks discussed above, would you like to know about our 10 finest buy-and-holds for the year?
Who wouldn't? Our annual Top 10s have beaten the market with amazing regularity. In 2018, while the market dropped -5.2%, the portfolio scored well into double-digits overall with individual stocks rising as high as +61.5%. And from 2012-2017, while the market boomed +126.3, Zacks' Top 10s reached an even more sensational +181.9%.
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