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Why Is Ultragenyx (RARE) Up 12.4% Since Last Earnings Report?
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It has been about a month since the last earnings report for Ultragenyx (RARE - Free Report) . Shares have added about 12.4% in that time frame, outperforming the S&P 500.
Will the recent positive trend continue leading up to its next earnings release, or is Ultragenyx due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important catalysts.
Ultragenyx Reports Narrower-Than-Expected Loss in Q4
Ultragenyx reported loss of $1.73 per share in the fourth quarter of 2018, which was narrower than loss of $1.89 in the year-ago quarter. Loss was also narrower than the Zacks Consensus Estimate of 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 included $1.6 million received from Bayer in relation to Ultragenyx’s research agreement with the former to develop adeno-associated virus gene therapies. Ultragenyx received $1.3 million in profit sharing and royalty revenues from the collaboration partner based in Japan, 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.
2018 Results
For 2018, the company reported 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.
How Have Estimates Been Moving Since Then?
In the past month, investors have witnessed an upward trend in fresh estimates.
VGM Scores
At this time, Ultragenyx has a poor Growth Score of F, however its Momentum Score is doing a lot better with a B. However, the stock was allocated a grade of F on the value side, putting it in the lowest quintile for this investment strategy.
Overall, the stock has an aggregate VGM Score of F. If you aren't focused on one strategy, this score is the one you should be interested in.
Outlook
Estimates have been trending upward for the stock, and the magnitude of these revisions looks promising. Notably, Ultragenyx has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months.
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Why Is Ultragenyx (RARE) Up 12.4% Since Last Earnings Report?
It has been about a month since the last earnings report for Ultragenyx (RARE - Free Report) . Shares have added about 12.4% in that time frame, outperforming the S&P 500.
Will the recent positive trend continue leading up to its next earnings release, or is Ultragenyx due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important catalysts.
Ultragenyx Reports Narrower-Than-Expected Loss in Q4
Ultragenyx reported loss of $1.73 per share in the fourth quarter of 2018, which was narrower than loss of $1.89 in the year-ago quarter. Loss was also narrower than the Zacks Consensus Estimate of 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 included $1.6 million received from Bayer in relation to Ultragenyx’s research agreement with the former to develop adeno-associated virus gene therapies. Ultragenyx received $1.3 million in profit sharing and royalty revenues from the collaboration partner based in Japan, 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.
2018 Results
For 2018, the company reported 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.
How Have Estimates Been Moving Since Then?
In the past month, investors have witnessed an upward trend in fresh estimates.
VGM Scores
At this time, Ultragenyx has a poor Growth Score of F, however its Momentum Score is doing a lot better with a B. However, the stock was allocated a grade of F on the value side, putting it in the lowest quintile for this investment strategy.
Overall, the stock has an aggregate VGM Score of F. If you aren't focused on one strategy, this score is the one you should be interested in.
Outlook
Estimates have been trending upward for the stock, and the magnitude of these revisions looks promising. Notably, Ultragenyx has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months.