La Jolla Pharmaceutical Company LJPC has an upcoming catalyst in the form of a Feb. 28 PDUFA date. An analyst at H.C. Wainwright recommends buying of the shares ahead of the decision.
The Analyst
H.C. Wainwright analyst Edward White initiated coverage of the shares of La Jolla with a Buy rating and a $62 price target.
The Thesis
The top-notch rating is based on the outlook for La Jolla's pipeline, including LJPC-501 and LJPC-401, White said in a Thursday note. (See White's track record here.)
LJPC-501 is La Jolla's proprietary formulation of angiotensin II, a naturally occurring regulator of blood pressure, and LJPC-401 is its proprietary formulation of hepcidin, an endogenous peptide hormone that controls and regulates iron metabolism.
With the company having submitted the NDA for LJPC-501 — a treatment candidate for vasodilatory shockm — to the FDA, the PDUFA date is set for Feb. 28, White said. The company released positive Phase 3 data from the ATHOS-3 Phase 3 study for LJPC-501 in late February 2017, sending the stock higher, the analyst said.
White expects the company to launch LJPC-501 in March 2018 pending approval. La Jolla plans to submit a marketing authorization approval for the product in the third quarter of 2018. The pricing is expected to be $5,000 per patient course, White said.
La Jolla's LJPC-401 for iron overload is now being evaluated in a pivotal clinical study in patients with beta-thalassemia and in a Phase 2 study of hereditary hemochromatosis, according to H.C. Wainwright.
The firm estimates revenues of $27 million for 2018 and $113 million for 2019, against consensus estimates of $33 million and $97 million, respectively. The below-consensus revenue guidance for 2018 is due to a slower ramp up rate, White said.
The Price Action
The shares of La Jolla are up about 55 percent year-to-date.
Related Links:
Attention Biotech Investors: Mark Your Calendar For These December PDUFA Dates
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