Ultragenyx Pharmaceutical (RARE - Free Report) reported loss per share of $1.82 in the first quarter of 2019 against profit of 62 cents in the year-ago quarter. Loss was also wider than the Zacks Consensus Estimate of a loss of $1.73.
For the first quarter, Ultragenyx reported $18.2 million in total revenues, up from $10.7 million in the year-ago quarter. However, revenues missed the Zacks Consensus Estimate of $19.3 million.
Ultragenyx recognized $14.5 million in total Crysvita revenues. This includes $11.9 million of collaboration revenues in the U.S. profit share territory and $2.0 million of royalty revenues in the European territory from the collaboration and license agreement with Japanese partner, Kyowa Hakko Kirin. Net product sales for Crysvita in other regions were $0.6 million. Revenue also includes $0.3 million received from Bayer (BAYRY - Free Report) in relation to Ultragenyx’s research agreement with the former to develop adeno-associated virus gene therapies. Mepsevii product revenues were $2.7 million and UX007 revenues were $0.7 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 2018 for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients aged one year or older. Strong launch of the drug in the United States continued. Crysvita was approved in Brazil for the treatment of XLH in adults and pediatric patients aged a 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 increased 54.7% year to date compared with the industry’s growth of 5.2%.
The FDA granted Fast Track designation and Rare Pediatric Disease designation to UX007 for the treatment of long-chain fatty acid oxidation disorders (LC-FAOD). Ultragenyx is on track to submit a new drug application (NDA) to the FDA for UX007 in mid-2019 to treat LC-FAOD.
The company reported positive longer-term results from the first cohort of the phase I/II study of DTX401 gene therapy in Glycogen Storage Disease Type Ia (GSDIa). Data from second dose cohort of the phase I/II study in GSDIa is expected by mid-2019.
The company reported data from the first two dose cohorts of DTX301 gene therapy in Ornithine Transcarbamylase (OTC) deficiency. DTX301 phase I/II data from the third dose cohort are expected by mid-2019.
Ultragenyx reported wider-than-expected loss and missed sales estimates in the first quarter of 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.
The company expects strong momentum from the Crysvita launch in the United States. Further, the company remains on track to submit UX007 for LC-FAOD for regulatory review in the coming months, and is advancing its gene therapy platform with key data readouts expected from two clinical programs. In addition, the company plans to move three preclinical programs into the clinic in 2020.
Zacks Rank and Stocks to Consider
Ultragenyx currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks are Fibrocell Science Inc. (FCSC - Free Report) and Ligand Pharmaceuticals Incorporated (LGND - Free Report) . Both the stocks carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Ligand’s earnings per share estimates have increased from $28.72 to $29.14 for 2019 and from 24 cents to 69 cents for 2020 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, the average being 37.44%.
Fibrocell’s loss per share estimates has narrowed from $2.68 to $1.15 for 2019 and from $2.55 to 97 cents for 2020 in the past 60 days. The company delivered a positive earnings surprise in two of the trailing four quarters, the average being 28.30%.
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