Let's start off with pSivida Corp (NASDAQ:PSDV). This is a small drug maker with a market capitalization of just north of $100 million. pSivida is a provider of miniaturized, sustained-release drug delivery products.
Their lead development product is a compound named Iluvien and is licensed to Alimera Sciences, Inc. (ALMN). The FDA has approved Iluvien for the treatment of Diabetic Macular Edema for patients treated with a course of corticosteroids and did not have a significant rise in intraocular pressure. The company has developed three of the only four products approved by either the United States or EU for the long-term, sustained-released delivery of drug to treat chronic eye disease. Global sales of Iluvien were just over $22 million in 2015 and it should continue to grow as it's applied to new indications and rolled out in new countries.
The stock has quietly moved up some 20% in the past month. The company should file a New Drug Application (NDA) with the FDA for Medidur™ for the treatment of chronic noninfectious uveitis affecting the posterior of the eye sometime in the first half of 2017. It should file for approval in Europe by the end of the year. The company reported successful Phase III trial results for this treatment late in 2015. The company provided solid six month safetyresults in mid-March. Submission of the NDA could be a positive catalyst for the stock when it occurs in the near future.
Medidur is the first fully owned product by pSivida. This product provides treatment of posterior-uveitis, for 36 months from a single administration. The company also has an interesting compound to treat Osteoarthritis in Phase II and other pre-clinical drugs as well.
The company ended 2015 with some $21 million in net cash on its balance and raised a little more than $16 million in a secondary offering in January. At its last conference call, management guided to an average quarterly burn rate of $5 million this year to fund operations and development. This means the company is well funded until late 2017 when recurring revenue should be established with Medidur.
Posterior-uveitis affects just under 200,000 individuals in the United States and results in blindness in about 30,000. This obviously is a large addressable market. Only three analyst firms cover this small cap concern. Their price targets from $6.00 to $12.50 a share. PSDV currently trades just above $3.25 a share even with its recent rally.
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