Thursday, May 31, 2012

ELTP - P&D or Stock Hero ?

Tough to call these days, the market is at an all-time low for marginal companies.  These days a lot of really great news won't budge the PPS upward.  In fact, if there's anticipation for the news and a run-up brings the stock up 20-40%, chances are there will be a sell-off.  This happened to ELTP after the announcement that they were awarded a patent for 216, a huge accomplishment that gave the shareholders going long more reasons to question the meaning of life.  The stock moved up to a 26-week high of .17(and change) prior to the announcement on May 22nd, and since then the stock has slipped down in to the .11 range.  11 cents?  So what is really going on here? So much.  The nature of the beast is there's still too many people betting for ELITE to lose for a little patent tech to be that driving force.  I know, right? Anyway, lots of great links and DD to find out there.  While the margin of error is slim for ELTP, there's so much to look forward to.  The company isn't pumping us with useless PRs or weak CCs.

Following a few posts over Ihub (shoot me now), here's today's vibe...  which you will notice hasn't changed a whole lot in recent weeks/months/years.

by poster TOOFUN:
Unfortunately, I have to keep this brief. Unlike the vast majority of penny stocks, this one has a foundation in reality. Meaning products that are presently on sale or soon to be on sale and a reasonable promise of future drugs (including the return of Lodrane) which are not dependent on some binary phase three efficacy event, which have a tendency of "blowing up" in a bad way. No this investment/company is grounded in the mundane world of generic retreads and has added value in the prospects of its own novel drugs in the not too distant future. TEVA didn't get to be TEVA through great invention just hard work. Grinding out each quarter with well applied effort through sound management is what I believe the company is doing and that in the end will make it profitable and eventually hit the home runs. This is what makes ELTP a novel penny stock and a good investment.
JMHO.
OK, so that wasn't brief.

 by poster dLOW:
Hyping the 2 bead patent like it is some kind of miracle invention. Claiming that the SPA assures fast track status and a 505b2 filing (the SPA does not), claiming that the Pfizer oxy/naltrrxone product has stability issues (why would they bo doing clinical trials if that were true), claiming that the company has mega millions in revenue- it doesn't, etc etc etc. It will be fun to watch Lite during this process.

by poster Tangerine:



Summary - Facts
Added in the mfg and the hiring and updated the patent date
The huge news is that it looks like Elite is getting the abuse resistant patent. This was the company's primary focus when they traded on the Amex. The tech is for all Opiates. It is a $20 billion dollar market. Well, it looks like they got it!
"The issuance of this patent is an important milestone for the company. It validates our pharmacological approach to the development of abuse-resistant drug products and provides additional value for these products," said Jerry Treppel, Elite's Chairman and CEO. "
Elite has been moving forward, rapidly growing its pipeline, partners and revenue sources. Most of the revenue producing products are just recently approved/launched. Many more are close.
Fact, one year ago they had one product, now they have 4 and they are just in their infancy for the most part. One year ago they had a couple partners, now they have upwards of 7 and some like Actavis and HITK quite large and global
Cash flow positive - ~500k - should be close this past Q- from the NJEDT from their program to assist companies. Elite was ~500k in the red the previous on just R&D, Phentermine and newly launched Lodrane D. The CFO noted that R&D revenues were continuing as they were. Simply add in the 500k, the launch of generic methadone and hydromorphone(dilaudid)
FACT based on simple math and listening to the CC
Operating profit - Will depend on the items above, as well as the items noted below. Should be close based on current projections in Q1, and met in Q2.
FACT based on simple math and listening to the CC
Approval/Launch of generic Naltrexone - Inspections were completed back in August. Supplement application for change of facility ~November/December - Due any time
FACT based on numerous filings, and listening the conference call
Approval and Launch of 4th ANDA - Also inspected for in August. Due any time
FACT just based on listening to the CC and numerous filings
Beginning of R&D for Hong Kong deal. Elite is developing an NDA for a Hong Kong Pharma company - Deal signed a couple weeks ago. Product already exists overseas.
FACT based new deal signed unless you believe the company is not telling the truth and really didn't sign a deal
Launch of 1st of 8 Epic drugs - Elite gets a profit split and I think milestones. Submitted to FDA quite a while ago
Fact From CCs and numerous filings
Hi-tech (HITK)- Partnership on generic of 100m branded product - development and manufacturing deal. Been working on this for over a year. Milestone, R&D and profit split I believe
Fact From CCs and numerous filings
Actavis/Mikah products for contract mfg - (Isradipine, Phendimetrazine) and working R&D MIK001. Elite is making Mikah's leading products per their website. Tech transfer began quite a while ago. Again, waiting on the FDA. Note that Mikah has increased the number of products on their website, with many approved ANDAs. We will see if Elite will be making these.
Fact From CCs and numerous filings
Lodrane 24, 24D expected return- 3rd, 4th quarter - ! 1 year ago, Elite hit operating profit on these two products alone. Then the FDA pulled 500 cold meds. Being worked as an NDA
Fact based on discussion with ECR
Socius funding - Elite has access to 5m in funding if they need it for PH3 of Eli 216
Fact From CCs and numerous filings
PH3 Eli - 216 - Market data has this once a day abuse resistant Oxycontin, PH3 pending product at 800m. Protected by the patent being approved.
Fact and discussed a million times with proven independent market data
Eli 154 - Once a day oxycontin - Elite has a partner willing to fund half, need second half
Fact based on CCs and filings
Another pending ANDA - submitted more recently
Fact based on CCs and filings
Fact - Elite is hiring
Fact - Elite is almost completed with their second manufacturing facility which doubles there capacity

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