Alimera Sciences (ALIM) is a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals. Presently, Alimera is focused on diseases affecting the back of the eye, or retina.
On May 1st, Alimera announced that its recent resubmission of the New Drug Application (NDA) for ILUVIEN has been acknowledged as received by the U.S. Food and Drug Administration (FDA) as a complete class 2 response to the FDA's November 2011 letter and that a new Prescription Drug User Fee Act (PDUFA) goal date of October 17, 2013 has been established.
ILUVIEN is Alimera's sustained release intravitreal implant that delivers sub-microgram levels of fluocinolone acetonide (FAC) for up to 36 months for the treatment of chronic DME. The clinical trial data showed that in patients with chronic DME at month 30, after receiving the ILUVIEN implant, 38 percent of patients experienced an improvement from baseline in their best corrected visual acuity on the Early Treatment of Diabetic Retinopathy Study (ETDRS) eye chart of 15 letters or more. At the completion of the 36-month study, 34 percent had achieved the same result. This effect was highly statistically significant as compared to the sham control group, which received laser and other intravitreally administered therapies
In the resubmission, Alimera responded to questions raised in the FDA's letter and provided additional analyses as well as new information to support that ILUVIEN is safe and effective in the treatment of patients with chronic diabetic macular edema (DME).
ILUVIEN® has received its marketing authorization approval in Austria, France, Germany, Portugal, Spain and the United Kingdom and is going through the national phase in the approval process in Italy.
On May 7th, they announced that ILUVIEN®, the first sustained release pharmaceutical product for the treatment of chronic diabetic macular edema (DME), is now commercially available in Germany. It was also announced, on that day, that they had treated the world's first patient with the implant injection since the product became commercially available.
Revenue from the six European countries will start to roll in the remainder of 2013.
Here is a wonderful breakdown of the potential revenue for Iluvien. To see this great article in full go here.
Approximately 10% of diabetics will develop Diabetic Macular Edema. The proposed price for Iluvien in Europe will be somewhere between $5,500 to $8,800. For the purpose of this article I will use the average, which is $7150.
Has approximately 400,000 diabetics.
400,000 * 0.10 = 40,000 potential patients
40,000 * $7150 = $286,000,000 sales
900,000 * 0.10 = 90,000 potential patients
90,000 * $7150 = $643,500,000 sales
3,945,753 * 0.10 = 394,575 potential patients
394,575 * $7150 = $2,821,211,250 sales
Has approximately 3,635,946 diabetics
3,635,946 * 0.10 = 363,594 potential patients
363,594 * $7150 = $2,599,697,100 sales
Has approximately 7,372,226 diabetics
7,372,226 * 0.10 = 737,222 potential patients
737,222 * $7150 = $5,271,137,300 sales
I will use a cost of $5500 for the U.K. since it is most likely to be lower in the U.K.
Has approximately 3,636,375 diabetics
3,636,375 * 0.10 = 363,637 potential patients
363,637 * $5500 = $2,000,003,500 sales
From what you can see above, the potential revenue possibilities are enormous. Alimera's fully diluted share count is 44,199,512. At today's price per share value of 3.11, it would have a market capitalization of 138 million. If the company produces even 15% of the above projected revenues, it would equal 2.1 billion. This is not even including the U.S. market, which i feel will be a slam dunk on October 17th.
Alimera shares the revenue with pSvida Corporation (PSDV), in which 80% goes to ALIM and 20% goes to pSivida for its tiny, sustained release, drug delivery implant in which Iluvien is delivered.
Therefore, based on the above projections, presuming that Alimera will get 1.6 billion in revenue, the share price target of Alimera should be way north of $10.00. Analysts will be coming out with their price per share targets well above this prediction very soon. Best to be in early for big profits.
Trius Therapeutics (TSRX) is a biopharmaceutical company focused on the discovery, development and commercialization of innovative antibiotics for serious, life-threatening infections.
Tedizolid phosphate (TR-701) is an IV and orally administered second generation oxazolidinone for the treatment of serious gram-positive infections, including methicillin-resistance Staphylococcus aureus (MRSA).
Acute bacterial skin and skin structure infections (ABSSSI), a new FDA classification for complicated skin and skin structure infections (cSSSI), are a significant and growing problem throughout the world.
ABSSSI are infections that involve deeper tissue or require surgical intervention (e.g. cellulitis, major cutaneous abscesses, and infected wounds) or are associated with a significant underlying disease (e.g., diabetes or systemic immunosuppression) that complicates response to therapy. A variety of pathogens may be identified in ABSSSI but the two most common Gram-positive pathogens are Staphylococcus aureus and Streptococcus pyogenes. The significant increase in the incidence of MRSA in community as well as hospital acquired infections has resulted in a need for therapy of ABSSSI that is effective against MRSA.
The recent phase 3 results met primary and secondary endpoints. Now we await the company to file an NDA (New Drug Application), which should be in August- September.
On Friday, Guggenheim initiated coverage on Trius Therapeutics with a buy and a $20.00 price target. A number of other analysts have also recently weighed in on TSRX. Analysts at Zacks reiterated an "outperform" rating on shares of Trius Therapeutics in a research note to investors on Monday, March 25th. They now have a $12.00 price target on the stock. Separately, analysts at Aegis raised their price target on shares of Trius Therapeutics from $14.00 to $18.00 in a research note to investors on Monday, March 25th. They now have a "buy" rating on the stock. Finally, analysts at Oppenheimer reiterated an "outperform" rating on shares of Trius Therapeutics in a research note to investors on Wednesday, March 13th. They now have a $12.00 price target on the stock.
For investor looking for big gains in the short term, ALIM and TSRX present compelling opportunities to more than double your money. The companies are attractive speculative picks for potentially high returns. These 2 stocks will be among the biggest gainers for 2013.