pagiantmetknicksfan@yahoo.com
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
It is very interesting. Actavis has oxycodone now. Mikah apparently has Percodan and per the Mikah website MIK001 is in the works. Lots going on here. It should get interesting.
That's your post?
You all should take some time this weekend and listen to the call again. I think you might be surprised.
A couple notes
Contract manufacturing includes the Mikah drugs and the Methadone. That can begin as soon as the technology transfer is complete. They get paid for the tech transfer as well
Maybe the most important thing I heard on the call which I didn't catch the first time was Treppel responding to a question about finding new partners
"Now as opposed to the past we are not the ones making the calls"
A few more tidbits but do yourself a favor, especially if you are heavily invested and need a sanity check, take another listen
He is paid in stock.
Thoughts on the conference call
Nothing new that we didn’t already know. The Lodrane issue has been known for three months. Hydromorphone is delayed and Naltrexone may have the same issue. We have known this for almost a month. Phentermine is just starting to be sold. I think we will get good revenues once things get going but it just started to get sold. Seems Methadone can be out the door quickly based on the call as well.
I think folks are missing the point as to why Jerry Treppel is so ticked off. It is because without the FDA issues, this company would be off and running and profitable. However, the stock price would not be .17 either. More like 2-5x that or more. I don’t like to give predictions on these things except when it comes to the patents.
His people have worked extremely hard to get them this far and he is showing them that he is on their team and appreciates what they have done. I’ll work with a guy like that anytime. He is also showing them and us that it is personal to him and he will fight until there is no fight left to be had. Fortunately, Elite has many, many big things in the future. And don’t forget, this guy takes his salary in stock made the company profitable from its manufacturing business, saved it from bankruptcy and has it on a path for success.
Regarding Lodrane, it seems it could go OTC but that is not the direction ECR seems to want to take right now. They do have a petition filed but that could take time. Seems they want to either get extra time from the FDA or get the ANDA/NDA approved over the required period. They need time to do this and Elite has been working on this with them since last year producing test batches and assistance with the approval requirements. It’s in the filings. Jerry also mentioned a smaller product in relation to this that could come to fruition but seems that would be later on, and in lieu of a Lodrane resolution short term.
New Products coming:
We literally have 20 products in the pipeline. Most of these products are widely distributed and generate hundreds of millions of dollars in revenue in total. Will it make up the 4 million we are losing for Lodrane? Likely to be several times over, but it will take time to get them all going to their maximum potential.
Hydromorphone. Naltrexone, Phentermine, TAGI intermediate drug, Methadone, ANDA we filed this year, ANDA coming filed last year, Isadiprine 2.5mg, 5mg, Phendimetrazine Tartrate, ELI 216, 154, 8 EPIC drugs, 2 others on the website. - Gastrointestinal and anti-biotic...And this is what we know about today. I think I am missing one or two but that is from memory.
ELI 216 and 154
This is why I invested so heavily in Elite. Both patents are well into the approval cycles. As Jerry Treppel noted with the recent FDA action on Remoxy, ELI 216 drug is more valuable than ever. It also seems we are close to a partner for ELI-154 in Europe. Jerry can’t divulge the ongoing discussions until there is a deal. When these patents get approved, Elite will blow up, it’s that simple. Eli-154 may go through overseas without the US approval it would seem as well.
Mikah CT order – Actavis
I hope my little discovery in the 10k didn’t screw anything up. It is obvious to me that they don’t want to discuss this right now. The question although put very poorly from an inexperienced caller, was avoided. Jerry earlier in the call referred to them a “very large generic company” and then quickly moved on. Do a little research on them. They are a massive, well known, with worldwide distribution.
I suspect this is just the beginning of this relationship. Seems we received the Hydromorphone and Naltrexone ANDAs through this relationship already.
I always say that this stock is a real investment, it’s a real company but things take time. The FDA is a bureaucracy, and painful to deal with. Patience rewards the diligent. Good luck to all longs.
And purchase orders
" Purchase Orders. Mikah or Actavis, Mikah’s designee, shall submit Purchase Orders for Product (“Purchase Orders”) specifying: (a) the number of units of Product to be purchased, (b) the Price, (c) the expected delivery date, and (d) such other special terms and conditions that may be applicable to such order. For every delivery, per Product, a firm binding order must be made at least two (2) months in advance of delivery date or such lesser period of time that the Parties may agree to, in writing."
Mikah is Actavis
The deal with Mikah for the 3 ANDAs which have revenues of over 50 million among a few manufacturers. I believe that is USA, is with Mikahs designee...Actavis.
They are a worldwide multibillion dollar company
http://en.wikipedia.org/wiki/Actavis
That is a 5 year deal - from 10k below
"Forecasts. Commencing three months before the anticipated commercial launch of each Product, Mikah or Actavis, Mikah’s designee, shall provide Elite with non-binding rolling twelve (12) month forecasts of its Product requirements by delivery date"
You have a long and negative history on that board. Just review your message history for the last three months
To me, this has never been a typical penny stock although it can be manipulated like one. Lots of folks holding waiting for hydro, or naltrex, or patents. This has always been a long term play and with Epic barring against a chance of BK, nowhere to go but up. Lots of catalysts and homerun potential. Do not underestimate the power of the patents here. They will take this over a dollar in a blink. To me, its a very safe stock because of Epic and the generics.
The volume during the april run was insane. I don't believe that was all retail and then the careful control to keep the price down the last couple weeks. Same mm's on the bid and asks
Don't forget, we had 60 million share days with large amounts of those shares trading in the 20s. And that was with only 100m share float
And you asked what my game is? I own 1 million shares and believe we are in for a long ride up. The below was before the big deal with Mikah which barely begins to show just how undervalued this stock is.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=63907456
you absolutely did name the poster and its still there. You asked what is your game? Your game is to try and gain credibility
I believe they are fast tracking bcause of all the public attention and politics involved. I'll take the patent approval now though! The 24 hour patent should not take too long for ph3 because they are known used everyday drugs. The question becomes whether or not they can maintain plasma levels and pevent breakthrough pain. Elites tech is for real.
What he said. Man get the friggin patent approved and we will fly. That's not pumping, that is fact!
Remoxy rejected. Can't link the article right now. Things just getting better and better
You didn't answer the question. Just give a range at least. What will the pps do? You've invested $15k, surely you have thought about it? It can happen at any point.
You don't have a target pps or a value you've assigned to the stock?
Now what if the abuse resistant patent is approved? That is also worth hundreds of millions for Oxy. What would the pps be then?
Both patents are due to be approved now and ph3 is pending. So what is your target pps?
Poorme,
What do yhou thing the pps will jump to when the patents are approved? The extended release patent would give Elite over 70 proprietary hard to formulate pain medications potentially woth 100s of millions of dollars.
Everyone of your posts is negative, deceitful, sneaky and boring. Why are you here? Just tell the truth. The regular posters here know why so tell everyone else.
Its because of the naked short selling it back down but you already knew that didn't you?
Short squeeze is coming with earnings or patent approvals or new agreements or shipments we know are coming
This stock is not a flipper penny that you buy and dump. The below link has a ton of info and should be stickied above.
It does not include the latest deal with Miakh for the new 3 ANDAs
If you don't think this is a good investment after reading that, going through the links and doing your own due diligence, just sell your stock
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=63907456
If you dislike this stock and company so much why are you spending so much time on a message board for the stock?
Short shares are nervous right now. By a dramatic amount the short volume was down to 2.5% yesterday. Normally it had been averaging around 30% and over the last two weeks a steady decline to avg around 10%. Friday was the exception with close to 30% short at 800k.
Yesterday was a lot of covering
You should definitely sell your pretend shares then.
Based on your post history, no one believes you own any shares. You are not interested in the positives of the company and your questions don't make any sense.
I'm not stressed. We are progressing very nicely and the charts look great. Products are queud up. Just waiting on the next set of patents, shipments, new products and earnings.
What is happening I they are getting nowhere on the ymb so he is trying here. Stock seems to be in strong hands that realize just how undervalued this company is and how many positive things are coming up. If the stock was already $1, they would have sort of a case to be made but until it gets there, ELTP is in great shape.
Isn't that the truth. Short volume way down today
Looking at the trades on this site
All the bids and asks are reversed or completely off.
Anyone know whats up?
If you add in the new drugs, which is tough to tell because this deal is sort of a cost with profit plus royalties, you get closer to $1 pps
can you point me to where wall street is bragging about this?
I think this is great news. Hydromorphone is coming either way bit now and it seems the manufacturing location is changing. Is it moving to Epic? Is it moving somewhere else? to their new manufacturing facility?
The new ANDA is a 50 million + a year drug and Elite is the only generic manufacturer I can find. GlaxoSmithKline and Elite.
Maybe if you were hoping to flip the stock you didn't get what you wanted but for a long like me it is another profitable drug. They are starting to add up.
Updated analysis including links and recent events. This is my best attempt to collect all and present all the date. Please feel free to add to this
This is not your typical penny stock. I am not a big time trader. Most of my holdings have been mutual funds and stock of larger corporations and mostly safe plays. When I found Elite in December I thought it was a good risk. Now with the previous conference call, deal with Epic, recent operational profitability, and conversion to a manufacturing mindset, I know that most of the risk is now gone. As Dianne from IR (Investor Relations) ends up saying to me every time I call her, and I paraphrase ; “This company acts like a big company because it used to be one and plans to be one again”.
How many penny stocks can you say that about? Most penny stocks have minimal revenue, tons of R&D costs and you are hoping beyond hope that some Phase 1 or 2 trials result will be positive, or that they sign a customer to avoid bankruptcy. All hedging or awaiting some miracle. Elite went through that stage and almost declared bankruptcy in 2009. They had offers to be bought out but were able to drastically cut costs and stay in business until their first operationally profitable quarter. That means they can start paying off their bills. This is where they were at the beginning of the year.
Where are they now?
Much closer than ever to becoming the company they set out to be when they were spending 10s of millions of dollars on R&D to perfect and patent their abuse resistant line of drugs and their 24 hour time release line of drugs. This is Elites Core plan, they have more than 7 patents, several just assigned in Europe and Canada, and in final review with the USPO. Abuse resistance was re-submitted on 5/17 for another review and extended release was re- submitted on 3/17.
12/640,344 (patent#) - ABUSE-RESISTANT ORAL DOSAGE FORMS AND METHOD OF USE THEREOF
10/951,978 (patent#) - Extended Release of Opiods.
These patents are not just for Oxycontin which has been in the news and is very controversial due to the high rate of abuse and addiction. The patent claims are actually for numerous drugs. Both hard to make 24 hour formulations and abuse resistance formulations. Notice there really isn’t a 24 hour Oxycontin pill available and the current abuse resistant ones are having problems. Also note that Elite is in PH3 with these drugs. The 10s of millions that they spend from 2001-2009 got them this far. They have European partners awaiting PH3 it would seem based on the website and conference calls.
http://www.elitepharma.com/investor_relations.asp?goto=330
Always keep in mind that these drugs are already FDA approved on their own merits. What is in question is Elites ability to maintain plasma levels and they have shown the patent pending ability to do this. That is the focus of their patents and what makes them unique and possibly a leader in the market.
Some links for interesting data on this:
Notice who Elite is named alongside and the revenue from these drugs
http://www.businesswire.com/news/home/20110412007011/en/Research-Markets-Chronic-Pain-Therapeutics-Market-Forecast
http://www.elitepharma.com/product_pipeline.asp
http://seekingalpha.com/article/251469-pain-therapeutics-optimistic-indicators-large-upside-potential
http://www.nipcweb.com/Purdue_Rivals_Oxy.pdf
Must read article “Alpharma Inc. and Elite Pharmaceuticals Inc. predict a $1 billion market for alternatives they're developing even if Purdue beats them to pharmacies.”
Also note that Oxycontin becomes a generic drug in 2013 so Elite will get their either way but the patents give them exclusivity of course.
Look up the patents for yourself (patent #s above) and you can read all for yourself:
http://portal.uspto.gov/external/portal/!ut/p/c5/04_SB8K8xLLM9MSSzPy8xBz9CP0os3h3cz9XEzcPIwMLvyALA08jF39LE2cjQwMLU6B8JG55dxNKdBuYEtAdDnItftvxyYPMB8kb4ACOBvp-Hvm5qfqR-lHmCFPcff3dgKa4ebh5BxgZG7gb6UfmpKYnJlfqF-SGRhhkBmQEOioqAgBVda8T/dl3/d3/L0lJSklna21DU1EhIS9JRGpBQU15QUJFUkNKRXFnLzRGR2dzbzBWdnphOUlBOW9JQSEhLzdfRzdORTRGSDIwR01PRjBJMkZIRktQMjMwRzIvVzBEVnE3ODYwMDAwNC9zYS5nZXRCaWI!/
So the above is the homerun. What happens if Elite has to go through more rounds and resubmissions with the patent office and FDA? They almost went bankrupt chasing this outcome until they implemented a new business plan. This plan as highlighted in the February conference call and put out for all to see is actually simple. Utilize their state of the art manufacturing facility to make generic drugs.
In fact they are doubling their manufacturing capacity now.
Epic already made drugs at this facility which is DEA and FDA approved. No easy feat and not that common. It means they can make controlled substances and ultimately will be making their unique and patented formulations of these drugs.
Where is the immediate revenue going to come from?
It started with Lodrane and as we saw, they were operationally profitable on about 4 million dollars. They only have 16 Elite employees. Epic manufactures many of the drugs out of the facility. Lodrane was a good moneymaker for Elite. However, in March the FDA pulled about 500 drugs off the shelves, giving a 6 month timeline for compliance. Elite will have to stop making the drug.
However, the active ingredients have been in effect for over 40 years and ECR who markets Lodrance for Hitech (HITK) has initiated a lawsuit against the FDA stating that Lodrane has the same active ingredients as Dimetapp and is not “grase”
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2011/05/dc-circuit-is-asked-to-review-two-desi-new-drug-decisions.html
“Last Friday, Petitions for Review were filed with the U.S. Court of Appeals for the District of Columbia Circuit on behalf of ECR Pharmaceuticals (“ECR”) and Laser Pharmaceuticals, LLC (“Laser”) requesting that the Court review and set aside FDA’s March 3, 2011 decisions (here and here) that certain marketed unapproved drug products are not Generally Recognized as Safe and Effective (“GRASE”). (Both FDC Act § 505(h) and FDA’s regulations at 21 C.F.R. § 514.235(b) permit a direct appeal to an appellate court within 60 days after the entry of a relevant FDA order.) “
So what happens if they totally lose Lodrane? Elite took care of this with their deals with Epic. Epic pharmaceuticals are now tied directly to Elite based on the recent deals.
http://www.epic-pharma.com/
http://investing.businessweek.com/research/stocks/private/snapshot.asp?privcapId=52171677
http://www.reuters.com/finance/stocks/ELTP.OB/key-developments/article/2128632
So based on this, we see 8 ANDAs being produced at Elites facility whereby Elite gets 15% of the profits. Based on research it appears some of these drugs maybe be already produced at Elite’s facility. There is also much speculation that Elite and Epic will form a reverse merger of sort. Conversion of preferred shares to common is often a predecessor for type of deal.
Elite was awarded Hydromorphone and Phentermine from Epic for them to produce on their own. They are partnered with TAGI. They also received Naltrexone ANDA from Mikah Pharmaceuticals LLC
http://www.healthcarepackaging.com/archives/2010/09/elite_pharmaceuticals_announce.php
“Pursuant to the License Agreement, TAGI Pharma will market and sell four Elite generic products (the "Products") in the United States, Puerto Rico and Canada. Elite will receive a license fee and milestone payments and Elite will manufacture the Products. The license fee will be computed as a percentage of the gross profit, as defined in the License Agreement, earned by TAGI Pharma as a result of sales of the products. The license fee is payable monthly for the term of the License Agreement. The milestone payments will be paid in 6 installments. The first installment was paid upon execution of the License Agreement and the remaining installments are to be paid upon FDA approval and initial shipment of the products to Precision Dose. Two of the Products, hydromorphone hydrochloride, 8 mg, and naltrexone hydrochloride, 50 mg, are approved products recently purchased by Elite and currently being transferred to Elite. Collectively, the brand products and their generic equivalents had total annual sales of approximately $120 million in 2009.”
Phentermine has a value of ~40 million per year with about 10 other manufacturers. They received this from Epic
http://americanpharmaceuticalreview.com/ViewArticle.aspx?ContentID=6276
Also note the following recent increase and notoriety for both Phentermine and Naltrexone
While a key ingredient in Elites abuse resistance technology, it is now found to be a remedy for Crohns disease as well as MS and AIDs.
http://www.lowdosenaltrexone.org/
http://en.wikipedia.org/wiki/Low-dose_naltrexone
I believe there are 5 manufacturers of this drug currently
And Phentermine has been recently at the forefront as an effective diet pill. This is not a new pill but it is receiving more and more notoriety. Do a google search and see.
http://thechart.blogs.cnn.com/2011/04/10/study-weight-loss-combo-pill-shows-promise/?hpt=C2
These are the drugs we know about. What else is coming in the immediate future? Based on the pipeline there are two more undisclosed ANDA drugs in development. We also know they are working on another ANDA with Epic and TAGI as described in the links above.
There is also a CT order in place which will be somewhat revealed in June I believe. This confidential treatment relates to a new or one of the above drugs.
http://quotemedia.10kwizard.com/cgi/image?repo=tenk&ipage=7577590&action=PDF&doc=1
http://messages.finance.yahoo.com/Business_%26_Finance/Investments/Stocks_%28A_to_Z%29/Stocks_E/threadview?bn=99215&tid=39138&mid=39138
If you go back through the SEC filings you will find that this is most likely related to another deal with Mikah pharmaceuticals and per Elite’s Investor Relations, done to maintain a competitive advantage. Basically you do not want other companies knowing what you are planning to release/develop. My guess is it is another ANDA. Also note that the Mikah VP who signed some of these agreements is also a special consultant to the CEO of EPIC. More on this in a bit
http://www.postjobfree.com/resume/hp88ni/qa-medical-technologist-regulatory-affairs-epic?id=fad8f6f4750449439de1e119b5be94c2
So how many drugs are coming out of Elites facility in the current and near term?
Phentermine, Naltrexone, Hydromorphone, Epics 8, New Epic ANDA, New Mikah ANDA? CT order product(s), 2 undisclosed from pipeline
Hopefully Eli 216 and 154.
Also in March, Elite won $500k and the right to produce Methadone with an approved ANDA
http://www.marketwatch.com/story/elite-announces-settlement-of-litigation-with-thepharmanetwork-2011-03-17
So what are the negatives and outlook for success?
Losing Lodrane hurts because it was what kept Elite in business over the last couple years. The new drugs can more than make up for it considering just Phentermine, Naltrexone and Hydromorphone represented 160 million in revenue in 2009. While I believe Naltrexone and Phentermine’s value has increased due to the recent notoriety and Naltrexone being used for other serious diseases, just 5% of the 160 million is double what they had for Lodrane.
Also note a couple things:
ECR and HITK began the FDA process for Lodrane in 2010. Their current lawsuit it for a stay of an additional 6 months to complete the FDA required submissions and the argument is that they were not given due process under the law and there is no imminent threat to the public. Makes sense considering the FDA is allowing it to be sold for an additional 6 months. Also note that Dimetapp uses the same exact active ingredients. My understanding is that ECR is spending millions to complete the FDA requirements. Lodrane is worth ~15 million/year to them. There are some other scenarios that have been floated about relabeling and other measures but that is not 100% clear to me. Also they may be able to produce the instant release version. Also not clear to me.
Dilution – This is a scary word for investors like me. However, the “dilution” has been a conversion of preferred shares to common shares. Some believe this may be a precursor to a merger with Epic. The share count did not change; Elite did not sell shares to get cash for operations. Simply put, the preferred shares became common shares and eliminated the need to pay dividends of ~$700k per year. Also note these are not Elite or Epic management selling shares but investors. In fact Elite insiders have actually purchased shares in the March timeframe.
Trellus and Morris selling shares – Both of these are old investors selling pieces of their holdings that they purchased at a much higher price. No one except them knows why they are selling. Trellus has been known to sell shares almost monthly. They have sold a few million this year including about2.5 million recently. Their holdings are still ~17.5 million shares.
Morris was an elderly businessman, I believe in his 80s. His shares were put in a trust for himself, his family and foundation. It appears that ~ 15/20 million shares were sold, primarily from his foundation and his wife and kids.
No one knows why they sold but it is important to know that neither him nor Trellus should be selling based on inside information. They helped finance Elite but are not “insiders”. I have a feeling it is related to tax write-offs and paying bills and retirement plans. I believe Trellus paid over $1 per share. That’s a big write off and worth a lot more than the current share price.
I am very encouraged by how well the PPS has held up despite these sales. It always seems that there has been a buyer for these shares as they were sold. I am not sure what is going on here but it looks like serious accumulation of this company. I saw it when we had 60 million volume days and again recently. These cheap shares have been in demand. Notice the failure to delivers on this stock, naked shorting etc. They have been having a hard time covering without shanigans. Elite’s Lawyers are aware of the failure to deliver issues.
Debt-like just about every small pharma company, Elite has debt incurred from their facility and their years of R&D. It appears they are now in position to begin paying that debt off.
Other items I have heard but are not accurate – Elite is not paying their bondholders, Elite is going bankrupt, no money in generics, no money in pain medications, it’s a scam company, etc…
Call Dianne at Elite for the full history on the company. It’s a real American manufacturing company, operationally profitable and a pipeline with almost unlimited potential. It is also not hard to understand their business plan. No miracle required here.
So who benefits from Elite?
This is the most important question. Follow the money; who stands to make money if Elite succeeds to the highest degrees? Who wants to see the PPS soar?
Elite CEO is paid a nominal fee but mostly in stock. My understanding is Jerry Treppel had a major investment in Elite and took over as CEO to ensure success of the company and protect his investment. Remember they almost went bankrupt in 2009 timeframe. New CEO and management implemented a smart and highly feasible business plan to bring in manufacturing revenue and have the partners to do it.
Epic and Elite execs are major shareholders. The two companies as described above are now tied together. Epic can ensure Elite is successful in the near and long term. This is what I believe spurred the recent rise in PPS more than anything. Actual company insiders have purchased stock. Epic can make Elite as successful as they want by supplying new ANDAs and keeping costs very low. We are seeing this already.
I have read numerous rumors that there could be a reverse merger between Epic and Elite. Epic does own and has access to enough shares to probably make this happen. The conversion of the preferred D shares is seen by some as a sign that this could happen. There are other tidbits regarding the June timeline being required to make this happen as it represents a specific timeline from other deals. This is not 100% clear to me but the data is out there to be investigated.
I do see it as a real possibility. Epic and Elites relationship is very symbiotic and Epic could get a ton of cash out of it. The PPS would certainly soar and the two companies could be a force due to their efficiency, unique product pipelines and generic manufacturing capacity. Elite makes 24 hours drugs that are effective and this tech can be used with many drugs. Elite has received buyout offers in the past but that was when their worth was at an absolute low.
Once bankruptcy was off the table, and the relationship with Epic is understood, much of the risk associated with this penny stock was taken off the table for me. Now they are executing on their business plan right in front of us.
Elite CEO has not been secretive about the desire to get back on the big boards, Nasdaq and a reverse split is not part of the plan to get there.
What lies in the immediate future?
Long term, this company is a no brainer to me. Without a threat of bankruptcy, the patents pending and the generic possibilities coming online now, especially in hard to formulate and controlled substances, the revenue is there and should only greatly increase.
This is just the beginning.
If you think about it, all of Elites products are at the forefront of news due to increased coverage over the concern of abuse of prescription drugs (Eli – 216, 154 and other formulations), danger and feasibility of diet drugs, increased success for new applications of Naltrexone and of course increased demand for generic drugs.
The timing is absolutely perfect. This explains why they are expanding their facility.
Hydromorphone and Naltrexone should be shipping at any time now. They are noted as pending launch on their website. Phentermine shipped in quick order so I have been expecting these two to ship soon
CT order is going to be somewhat revealed during the next conference call is also my understanding
Earnings report ~(7/7/11) should present outstanding numbers. Deal with Epic, TPN lawsuit, Lodrane manufacturing continued during this time and should have been done to meet the 6 months allowed by the FDA. I am expecting that to be larger than normal to ensure product availability through the allotted 6 months.
Also any milestone payments from Epic and TAGI. Epic s 8 drugs are likely in process. I noted multiple ANDAs being awarded to Epic recently.
We should also hear back on the ECR lawsuit with the FDA which seems like they have a very good case but I am not an attorney and do not know how this will play out.
And of course the patents should be very close to being reviewed with an announcement of the results. Dates of re-submission noted above. Seems each resubmission can take several months for review. The 24 hour patent especially should be soon since it was sent in on 3/17 I believe.
These are just the recent items we know about.
I am not in the pharma business nor am I in the financial business. This is the best of the data from doing my own due diligence and investigation. I suggest everyone do their own research and contact IR for more info.
I do know that this company has solid growth potential as a generic drug manufacturing company. I also know that their patents are for drugs and formulations that have potential that is measured in billions of dollars. 24 hour time release, abuse resistant drugs could easily be a preferred choice in the pain market. Elite seems to be the only company in position to actually make this possibility a reality especially with certain drugs like Oxycontin. The timing is now due to the current attention in the media and from the government.
If this stock was $1 would you be surprised at the growth potential? Maybe? At 15 cents, the only conclusion I can come to is that it is a very undervalued company but the volume we have seen shows me that people have noticed. I don’t believe this is an “if” company any longer but just a matter of “when”.
Here is my very conservative approach to calculating PPS using very low P/E of 12
Lodrane – 4 million
Naltrexone and Hydromorphone =120 million, figure 6.5 competitors (5 Naltex, 8 for Hydro), 50% of the revenue taken in goes to Elite = 120/6.5/2 = 9.2million
Phentermine – 40 million, 10 distribs, assume 10%*50%=1 million
Epics 8 drugs – Since we don’t fully know what the drugs are, we will assume each drug profit avg 2 million. 15% * 16 million = 2.4 million
So, very conservatively 4+9.2+1+2.4= 16.6 million dollars with approximately 250 million shares
= .066 x 12 = .79 cents for a very conservative pps.
I think Naltrexone will be bigger due to Crohns, Aids and MS usage
I also think Phentermine will be more due to recent press noted above.
And none of this takes into account all the patent pending drugs, new ANDAs pending, deal with Mikah etc
Crohn's disease info
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_E/threadview?m=te&bn=99215&tid=54445&mid=54445&tof=3&frt=1#54445
This has real potential. If they announced they had a new drug for this disease, what would the PPS rise to? How about an old one with a new application and results from a double-blind study. An already FDA approved drug.
Believe the company data, speculate, be smart. This is a real company with a real future. Not a typical penny stock which unfortunately creates a fertile ground for shenanigans to go on because there is a solid base of real investors and enough upward pressure to do what I note below.
What I have noticed over the last few days and especially today is that there is a game going on. In the morning they get the buyers out of the way, except there are fewer and fewer as the charts reflect what looks like mostly selling and unloading. That has mostly ended. Mr Morris selling the foundation shares didn't help things either. Its not even really trading at this point.
How would you make it look this way? Easy - place lower and lower bids and asks at the same time through multiple accounts/providers, eventually positioning yourself between an actual seller and your ask. So the seller moves in lower and lower to unload their shares to get under your ask. As this process continues, less buyers will come in and more potential sellers get nervous. rinse repeat. Also make it look like massive sells are going on. I saw plenty of big sells come in...almost as soon as the previous was moved and in the manner shown below. You think folks don't know you look at level 2? They can make it look like whatever they want, especially with potential buyers having been discouraged.
When you run out of actual sellers, you put a bid up very close to your ask. Today there was a bid of .122 and an ask of .1222 for about 45 minutes. Each side had in the ballpark of 100k shares. With the buyers out of the way, your shares are safe and it influences sellers to come in just under the .1222 bid. You take a risk of having those shares get bought but in the long run you are getting cheaper shares anyway. Works for shorting a stock, works for accumulating cheaper and cheaper shares.
Eventually most of the bid at .1222 was gone into the ether. Some may have been bought but others mostly sold underneath it. Otherwise you would have to accept that the buyer didn't want to spend an extra $20 on his $12k investment. Would you hold up a $12k trade for $20? Unfortunately I don't have access to the bid history but take a look at the trades today around 2:30 and the timeline.
Also keeping the daily losses under 10% is key I believe. Without news, this may continue but there are not many sellers or buyers right now due to this downtrend. News is coming, a lot of it over the next 1.5 months through earnings.
Also found some interesting info that is not really new. Remember Mikah Pharmaceuticals and the confidential arrangement mentioned in the SEC filing? The address of the company on the SEC filing, is for the vice president of Mikah who is also connected to Epic.
http://www.postjobfree.com/resume/hp88ni/qa-medical-technologist-regulatory-affairs-epic
Do your own research. Understand the companies business model, what they have accomplished, are accomplishing and whats in the pipeline.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=62870092
Buy this stock, don't buy it. I am willing to wait it out because for me it is not about "if" it is about "when" and there is no knowing what day it will be before the next catalyst. I am no stock expert but I see what I see. Its how I make my living.
GLTA
The question you have to ask yourself
Go look at the Yahoo board and the infestation over there. However, short volume is way down, in terms of volume and % and by a lot. Volume is down. The price is being forced down once the buyers ar out of the way. They want you to sell.
Why?
Some is definitely opinion, Its speculation. Its why investors invest. If all the cards were laid out on the table, there would be no game to play.
Bottom line which I am sure we can agree, this is a tremendous opportunity.
Would also love to discuss any differences in opinion. I am sure I am not 100% right.
send me yours and I will reply
Here is my analysis
Elite Pharmaceuticals is a manufacturing company. Previous management ran it as a mostly R&D shop pouring 10s of millions of dollars into their technology. This includes R&D, settlement with the original inventor, and ultimately some dilution to keep the company out of bankruptcy. The company on the brink of bankruptcy in 2009 changed management and began on a more stable path.
The plan?
Focus on manufacturing generics while continuing to move forward with their unique and powerful patent pending pipeline. This would allow for profitability, partnerships with top notch partners and a long term future. There were offers from companies to buy out Elite but ultimately the company found solid enough ground to maintain their ownership and move forward.
Management and ownership
Elite has a unique relationship with Epic Pharmaceuticals. Go to their website and see who they are. Epic has over 200 employees. Epic and Elite share board members and the Chief Scientist. These folks own very large quantities of Elite stock. Jerry Treppel, Elite CEO takes a minimal salary and receives the rest in stock. I also am pretty sure he was a large investor in Elite prior to the stock price demise in 2009 and has taken this role to help ensure that investment pays off. Recently, there have been numerous stock purchases by Elite Insiders. Go read the form 4s!!
Also in the most recent conference call, it was established that Elite is not looking for a reverse split and fully intends to get back on the big boards without this being needed. Calls to IR reveal, they are actually targeting the Nasdaq which means dollars per share.
Epic has purchased ANDAs for Elite. Epic has warrants for huge blocks of Elite stock that can be exercised to ultimately own a majority of Elite. Over 100 million shares I believe at .065. In the recent agreement with Epic, all in the SEC filings, Epic continues to use Elites facility which is either in the process or has already completed a large expansion. Elite will gain 15% of the profits of 8 drugs made by Epic at the Elite facility. This is just Elite collecting a large check and riding Epic who stands to benefit the most from the increase in PPS. Elite’s facility is on the front page of Epics website. Epic has a bunch of FDA approved ANDAs on the FDAs March approval list. Elite has the drugs below noted as well.
ANDAs for Phentermine, Hydromorphone as well as a yet to be disclosed two drugs have been assigned over to Elite from Epic. A gastro intestinal drug is in the works. These drugs along with Naltrexone have domestic sales in excess of 120 million dollars. That is just domestic. Elite’s distribution here is TAGI which can distribute worldwide.
Phentermine was shipped a few weeks ago. Note the stock price rise from this and the Epic deal as well as well as the incredible volume that followed. Also Phentermine received tons of press recently as an effective and possibly preferred diet drug that limits appetite. CNN, MSNBC ran info on this drug on the front pages of their websites.
Hydromorphone and Naltrexone are knocking on the door with a launch pending status. Elite’s facility is an FDA, DEA “state of the art” approved shop that has been making drugs for years. That is no easy feat. Shareholders are reaping the benefits of the millions poured into the facility during the companies R&D stage.
Other drugs coming out:
Go to the Elite site and review their pipeline. Epic is going to develop and provide additional ANDAs to Elite. Elite has done some classified R&D work with Mikah Pharma in exchange for an ANDA Naltrexone. Will work for ANDAs!!! What I still wonder about is, what were they working on? Remember this is a wonderful R&D company that is now fully using their manufacturing facility to be profitable which based on their last statements, have already achieved.
Elite’s technology:
Elite’s specialty is extended release and abuse resistant drugs. They have received and have multiple patents pending regarding this technology. Remember the 10s of millions of dollars they spent that almost put them out of business? That is what it was spent on. Also PH1 and Ph2 trials completed. PH3 is pending to begin with the approval of the patent. Also a European partnership is in the works per the last conference call. WIPO has assigned patents internationally. Go to the WIPO site and read what that means.
Oxycontin – If you watch the news you know how popular this drug is. It is billions of dollars and highly abused. Elite is using their technology to market this drug first although the technology works for other abused drugs and regular drugs as well. Both a 24 hour version and abuse resistant versions.
Elite’s Pharmacological approach – Elite uses Naltrexone to offset the ability to crush the Oxycontin and get high. Remember the ANDA they got from Mikah that is pending launch? That’s right; it’s the same Naltrexone drug. It is used to treat alcoholics and addicts with a high degree of success as it prevents the brain from receiving the ability to absorb the higher concentration of the Oxy.
The pending patent is based on Elites ability to do this effectively and in their own proprietary manner. It can be used with other Opiates. Hydromorphone (Dilaudid) an opiate has similar abuse problems. Yep, again, the same drug noted above pending launch by Elite. Could an abuse resistant Hydromorphone drug be in the works? It would make sense wouldn’t it? Not hard to connect these dots.
Elite’s 24 hour Oxy – Elite has been able to successfully maintain blood plasma levels sufficient for a 24 hour version of this drug. Google 24 hour Oxycontin and see if anything comes up. Elites got this one and the patent is pending. Imagine being able to take one pill per day to maintain relief from pain. Take it before you go to bed every night.
This tech also works on other drugs. These are billion dollar drugs. Imagine one that is also abuse resistant. It could easily become the pain drug of choice. Doctors can feel safer prescribing it as well and patients can maintain their relief from pain without risk of abuse!
The patents for both of these can be found on the Patent website. They are in their 3rd or 4th round of review which is common for pharmaceuticals. Go read them, but I warn you, they are dry and in legal language that takes several readings to begin to understand the arguments. Elite IR has noted to me that the attorneys representing Elite are some of the best in the business.
Recently Elite has been put in articles alongside Pfizer and other major players as the key companies in this field. It is a multibillion dollar field. Little Elite has 100 million float shares and a max count if everything was exercised and then sold by Epic of about 300 million.
Epic has no reason to do this. They are the ones that are going to benefit the most, including some of their executives. They would lose money for no reason. Also consider this; every dollar that Epic puts into Elite, is likely an expense and taken off their tax liability. As Elites PPS goes up, so does Epics wealth. So, effectively they increase their value with tax free dollars. I am pretty sure about this but I am not a tax accountant to be fully transparent here.
Recently generic and abuse resistant drugs have been in the news for a few reasons. There is a major problem with the abuse of prescription drugs especially opiates like Oxycontin. Also the cost of health care is driving the importance of generic drugs. Elites timing couldn’t be better.
So, it can’t all be good right? Elite stands to lose their main revenue source (Lodrane) with this drug, time released and 24 hour versions. Marketed by ECR through HITK, this was a 3-4 million dollar revenue stream. The FDA in March set out a timeline to pull these drugs off the shelves in 6 months. ECR has been working with the FDA since 2010 to keep this drug on the shelves. The main ingredients have been in service for over 45 years and they were not pulled for safety reasons per the ECR CEO e-mail posted on the Yahoo website.
ECR is also working through Congress to keep it on the shelves while they get the FDA all the information required for an NDA. This is going to cost ECR ~5 million dollars and they are spending it. Why? Because it is worth ~15 million to HITK. There has been discussion about keeping the instant version on the shelves as well as a relabeling of the product. This could end up being a “lemons into lemonade” situation. If ECR gets the NDA, they could take advantage of their new increased market share and reduction in the number of competitors.
Note what happened to the stock price when Lodrane was pulled. The stock price dropped back to .04 for a few days or so. I doubled down. The stock then proceeded to blow up with increasing volume as the Epic news rolled in alongside Phentermine shipment news. Lodrane revenue is replaced and Epic ensures Elite will march forward regardless.
Other negatives I have read
1) Dilution – As explained above, Epic would never dilute at the current PPS. First of all they could never dump that many shares. The form 4 would cause a complete sell off as well. That would be committing suicide. Talk about killing the golden goose!!! Any sell off would be reported in the SEC docs.
2) Trellus (Insider selling) Trellus helped finance Elite as explained above. They own ~ 20 million shares. They sell a very small portion of their shares about once a month. My understanding is it is to pay bills. They are way underwater on Elite. Note they haven’t sold during the recent run up. They are holding for the long term. Trellus not really selling despite the run from .04 to .26 tells you they think that better times lay ahead.
3) Lodrane – Addressed above.
4) There is no money in pain medication. One of my favorites
5) There is no money in generics. Just silly and not worth addressing.
6) Elites facility is not FDA approved. They have been used to manufacture drugs for years and are also DEA approved.
7) Bankruptcy – This fear was in 2009 and the deal with Epic ensured this will not be the case.
8) It’s a scam/pump and dump – This Company only puts out real press releases and delivers info via their SEC documents. Their IR person is easily available for discussion. They laid out an outstanding business plan and have been executing it on queue.
9) They are in default – My understanding is you can call of the creditor/manager of the debt and find out that this is not the case. Bridget Schessler is the name I believe. Again, see Epic agreement as well.
10) It takes years to get a drug through the FDA – That’s true, except Elite has been working on this for years and again, 10s of millions of dollars spent. They are closer than ever!
11) Not a profitable company. Elite says they just had their first profitable quarter. Also keep in mind Lodrane is still on the shelves. A good quarter should be forthcoming. I didn’t even get into all the milestone payments they are due for meeting their obligations to HITK and Epic.
Conclusion
The story of Elite is one to root for. A company with outstanding products, R&D, technology almost goes out of business. Then through new management, hanging on by the skin of their teeth they put together a sensible business plan to profitability all the while focusing on their patents. They reach profitability, have Epic backing them and are closer than ever to delivering what they set out to do ~10 years ago.
Their products are in the news, mentioned alongside companies like Pfizer. They are also undergoing a substantial expansion of their facilities. What I have written above is qualitative and actually not everything to be excited about but it helps to understand what is going on with this company and why the stock is moving and likely to move again soon.
However, go do your own research. Go read the documents. Focus on what the company has delivered to the SEC and to their investors. Listen to their last conference call and presentation. Call Dianne with IR. It is not a case of “if” with this stock, it is a matter of when and how fast and how high. I own ~400k shares with a handful to trade so I can increase my total share count. This is my analysis. This is what I believe to be real.
Also the makings of a short squeeze are in effect. Take a look at these numbers. Ignore the date, just the last 23 days minus Friday.
Look how many shares shorted below where we are today. They never thought it was going to stay this high in price. Too many shares bought above .20. They are screwed
number day / short volume / Overall volume / % short / Price
1-Jan 601355 1504019 39.98% 0.068
2-Jan 1726000 2541541 67.91% 0.07
3-Jan 1530721 2255496 67.87% 0.071
4-Jan 5315374 9393589 56.59% 0.083
5-Jan 2012543 4833840 41.63% 0.078
6-Jan 3759617 6964398 53.98% 0.069
7-Jan 2240686 5347761 41.90% 0.066
8-Jan 1932456 2745095 70.40% 0.07
9-Jan 1509760 2003507 75.36% 0.074
10-Jan 9791583 24108581 40.61% 0.09
11-Jan 6700627 15704636 42.67% 0.091
12-Jan 6434072 20476562 31.42% 0.117
13-Jan 19710309 55723371 35.37% 0.2
14-Jan 13474435 46413379 29.03% 0.188
15-Jan 15225091 45236134 33.66% 0.159
16-Jan 3072150 11306378 27.17% 0.168
17-Jan 5475594 15889898 34.46% 0.215
18-Jan 5860588 14755481 39.72% 0.235
19-Jan 3643611 14888663 24.47% 0.194
20-Jan 3266354 7637570 42.77% 0.217
21-Jan 2158524 5656277 38.16% 0.21
22-Jan 3890390 11304212 34.42% 0.195
23-Jan 1986327 5975708 33.24% 0.179
and they get to right off their investment in Elite until they cash out...