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

2nd Quarter Expectations

Some posters are out there claiming to be do good things for investors and potential investors.  Nobody can predict the future with certainty, so there is always a lowering of expectations, hard work and objectivity that goes in to being a trusted source for information.  Who do we trust versus who do we toss aside (or add to the ignore list)?    The key is to not allow any one to dictate your decisions with money.  You have that final say, and that should be empowering enough.

This is yet another post by Pagiantmetknicksfan. This poster keeps close tabs on the ELTP pipeline, and for a post that originated on April Fool's Day, it holds up well against anything any ELTP basher has advocated. Here's pagiant's post:

2nd Quarter Expectations

Naltrexone approval and launch – We learned that in November, Elite received the same supplemental approval requirement for change of facility as Hydromorphone. Thus the delay. Inspections occurred in August – Should be approved 2nd quarter

Predicted 4th TAGI ANDA approval and Launch – Inspections also in August. 6 months is typical for approval. We are 8-9 months. Expecting to see it 2nd quarter 2012. As noted by the CEO, ANDAs are taking longer and longer.

I predicted patent news saying that is was “very very close”– Both of the Eli patents were rejected. However, regarding Eli 216, Elite has submitted amended claims on 3/30 based on discussion with the patent examiner. The patent examiner stated that the results are unexpected (ie not obvious) so Elite’s argument is very strong. The rejection was that the argument cited ranges which were not represented in the claim. The claims have been resubmitted with these items removed. Again, this was based on Elite's discussion with the patent examiner. Elite has requested a quick approval as the USPTO basically agrees that the results were “unexpected”.

Eli 154 patent is not going to be pursued further. Elite stated they feel it is not worth the expense and will rely on their IP. They have a partner willing to fund half but still need the other half. Note that their tech in ELI 216 is also for the extended release.

Epics 1st of 8 Elite products - Transfer began some time ago but based on the current FDA timelines, it could be a quarter or two before approval. Up to the FDA.

HITK - 100m generic - I thought we might see news on this and I think we have. Look at the R&D revenues we saw in the previous Q and expected this Q.

Actavis drugs – The tech is undergoing transfer to Elite for contract mfg. This began quite a while ago. Since it is contract mfg and an approved product, I am hoping to see these products in Q2. Isradipine is the one to watch with a huge worldwide market and few competitors.

Lodrane extended products – The e-mail I received from ECR stated that they are hopeful to have the products back on the shelf towards the end of the year. The FDA requested add'l data. This puts NDA approval sometime 3rd Q to have the products out 4th Q, but you never know.

New Items

$5m funding through Socius. Will we see a tranche delivered for this money? I think this is for Eli 216 trials and that will likely be the trigger.

Deal with a Hong Kong Pharma for end to end development of an NDA – We don’t know what the milestones will be but I suspect there is some right at the front to pay for ramp up costs.

Cash Flow Positive – Pretty obvious. Elite ran ~500k in the red last quarter with just Phantermine, new Lodrane just launched and R&D. The CFO noted that that R&D revenue was on the same impressive pace as the previous Q. The NJEDT program gave Elite ~500k. This makes them cash flow positive by itself. Add in the revenues for contract mfg of Methadone which started this Q and launch of Hydromorphone.

Profitability – This is likely to be very close because of the addition of Hydromorphone and Methadone and continued growth of the existing TAGI products. If we can Launch Naltrexone, and/or a couple more products Elite should be able to hit profit. The big key for me here is the HK NDA development deal. Instant cash

New Epic deal – Could be big, could be just BAU type stuff

Update on Eli 216 studies, PH3 plans - ???

Add'l Mikah – More products added to their website and the statement that Elite will be making their leading products. I believe most of these were discont'd from Actavis Totowa NJ.

Elite's second facility coming online...

Elite Pharmaceuticals Announces Issuance of U.S. Patent for Abuse Resistant Oral Dosage Formulation

What a good long fight to win a patent of significant proportions.  This is a major battle the ELTP team has won after years of grappling with TPTB.

NORTHVALE, N.J., May 22, 2012 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP.OB - News) announced the issuance of U.S Patent No. 8,182,836 entitled "Abuse-Resistant Oral Dosage Forms and Method of Use Thereof" by the United States Patent and Trademark Office (USPTO). The issuance of this patent will further protect Elite's proprietary formulation for abuse resistant products utilizing the pharmacological approach. The Company has additional patents pending for its technology.

"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.

How will this fact impact ELTP's PPS?  Opinions are overwhelmingly positive in the chatboards, but who listens to those, right?  There is a poster going by the name Dr. Lowenstein you may see popping up on boards discussing information on ELTP.  It appears that he been given the magical gift of distraction.  His famous quote tagline is "LOL," and makes us all knowledgeable that ELTP has competition. And yeah there's a ton of other stories about life on the chat boards.  The speculation is interesting and makes our days, weeks, years go by.  Remember these people don't do what they do for free, it costs money to hold a beast like ELTP down for so long.  Facts are facts, investors.  And without question the person doing the most consistent/active DD on the boards is pagiantmetsknicksfan. Here is one of pagiantmetknicksfan's popular posts: 

(Editor's "Objective" Disclaimer -- Sorry Dr. Low, you don't have any worthy DD to add here.  The only real testimony to your DD is your ability to find weaker products from competitors to downplay this patent.)

The big news is Elite is getting the patent for their abuse resistant opioid technology. This patent can be used to develop abuse resistant versions of pretty much every opioid based drug.

Here is the patent App#, review for yourselves - (App# 12/478,952)

The opioid market ~ 20 billion dollars a year. Elite's closest competitor is Embeda which uses a core of Naltrexone but that product was pulled from the market for mfg issues.

Patent supports Eli 216, Elite's PH3 $800m, once a day abuse resistant oxy pill. You won't find one on the market.

While this is huge, there are so many pending items. Here is the list. Also, below is the list of IDs used to manipulate and confuse on this msg board. My opinion, verify everything for yourselves.

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.

Cash flow positive? - ~500k from the NJEDT from their program to assist companies. Elite was ~500k in the red the previous Q on just R&D, Phntermine 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.


Operating profit - Based on the items above, as well as the items noted below. Should be close based on current projections in Q1,and met in Q2.


Approval/Launch of generic Naltrexone - Inspections in August. Supp. application for change of facility ~November/December

Approval and Launch -4th ANDA - Also inspected in August. Due any time

New R&D for Hong Kong Pharma. Elite is contract developing an NDA - Product already exists overseas.

Upcoming launch of 1st of 8 Epic drugs - Profit split and milestones. Submitted to FDA quite a while ago

New 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

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 too.

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 with Elite providing support.

Socius funding - Elite has access to 5m in funding if they need it for PH3 of Eli 216 or other projects

And Eli 154 - Once a day oxycontin - Elite has a partner willing to fund half, need second half

Another pending ANDA - submitted more recently

ELTP Bead Technology

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