Ultragenyx Pharmaceutical (RARE - Free Report) reported loss per share of $1.87 in the second quarter of 2018 which was wider than the loss per share of $1.72 in the year-ago quarter. The loss excludes $40.3 million gain from Ultragenyx’s portion of the sale of the priority review voucher [PRV] received with Crysvita approval. Loss was however narrower than the Zacks Consensus Estimate loss of $2.10.
For the second quarter of 2018, Ultragenyx reported $12.8 million in total revenue. Revenues beat the Zacks Consensus Estimate of $5 million.
Total revenues include $8.9 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 $1.6 million in profit sharing and royalty revenue from Japanese collaboration partner Kyowa Hakko Kirin for Crysvita. Mepsevii product revenue was $2.0 million, and UX007 revenue was $0.2 million.
Please note that though UX007 is not an approved product, the company recognizes sales from UX007 on a “named patient” basis. This is allowed in certain countries prior to the commercial approval of a product.
We remind investors that FDA approved Crysvita in April for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients one year of age and 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 increased 70.7% year to date against the industry’s decline of 2.7%.
Ultragenyx gained aa positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in Europe for Mepsevii that recommended the marketing authorization under exceptional circumstances of Mepsevii for the treatment of non-neurological manifestations of MPS VII.
UX007 is being developed for the treatment of long-chain fatty acid oxidation disorders (LC-FAOD). The company is in discussions with FDA and EMA based on the phase II study for UX007 for a potential early submission of the new drug application (NDA) for the treatment of LC-FAOD.
However, per the FDA the data are confounded and are not sufficient to support a NDA. The company expects to end discussions in the second half of 2018. These discussions also should provide further clarity regarding whether an additional study would be required for approval.
The FDA granted fast track designation to DTX401 for the treatment of glycogen storage disease type Ia (GSDIa) in July 2018.
Some better-ranked stocks worth considering are Gilead Sciences Inc. (GILD - Free Report) and Vanda Pharmaceuticals Inc. (VNDA - Free Report) . Both of them carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
Gilead’s earnings per share estimates have increased from $6.11 to $6.57 for 2018 and from $6.36 to $6.48 for 2019 over the past 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 6.43%. The stock has rallied 8.4% so far this year.
Vanda’s earnings per share estimates have increased from 18 cents to 20 cents for 2018 and from 77 cents to 80 cents for 2019 over the past 30 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 133.1%. The stock has rallied 42.8% so far this year.
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