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I have been a pharmacist for 35 years and have recently been a manager for a large healthcare company, directly overseeing the purchase and distribution of hundreds of millions of dollars of pharmaceuticals. Being in the industry from the procurement and distribution side both, has given me a... More
  • Elite Pharmaceuticals - Progress Report To Becoming Profitable In 2013 21 comments
    Mar 10, 2013 7:25 AM | about stocks: ELTP

    Elite Pharmaceuticals (OTCQB:ELTP) has made significant progress in executing on it's business plan in the past 2 years. The likelihood of Elite achieving cash flow positive by the end of 2013 is high, and will be detailed later in this article, but first a brief history of Elite Pharma and what it has taken to get to this point.

    Elite Pharma was originally an IPO company and traded on the AMEX stock exchange in the 2000's. Formed to research and develop abuse resistant opioid drug products, the company had some great ideas and had achieved some very good patents for drug products, two of which it was able to assign to Celgene Corp. for a fee. http://www.elitepharma.com/patents.asp

    ELTP began studies on it's patent pending, at the time, abuse resistant 2-bead technology, and was able to move through Phase 1 and Phase 2 FDA studies successfully, and at that point the money began to run out and ELTP needed a Big Pharma partner, to come in and fund the studies. With previous management leaving and the company in financial disarray, the stock price slipped below the $1 per share listing threshold on the AMEX and was re-listed on the OTCBB where it trades today. There was a lot more that happened, but history of Elite is not the purpose of this article.

    As the company was almost out of cash and could have faced possible bankruptcy, exit the previous CEO, and Jerry Treppel was hired as CEO. He came onboard in 2009 with a mission to turn the company around, and to become an operating, profitable, player in the USA Drug Industry. He was previously a director at AKORN Pharmaceuticals, which has been one of the stellar success stories in the USA Drug Industry in the past few years.

    Jerry Treppel's mission to turning the company around had 4 major steps.

    First- New funding had to be secured to keep the company operating and for it to acquire ANDA drugs to develop and market at it's facility. This funding was accomplished with a deal with a private company EPIC Pharma, which, though dilutive, injected millions of dollars into Elite by giving EPIC essentially almost half ownership of Elite.

    Second- Elite had to get some products on the market and begin to generate cash flow, which it did by marketing 4 products in the cold and allergy market, the Lodrane Products.

    Third- With a large portfolio of products under development, manufacturing capacity had to be increased, therefore facility capacity was doubled by the addition of a 15,000 square foot facility to the manufacturing capacity.

    Fourth- The company continues with its now patented abuse-resistant product development, and has some products in development by itself, and with some very large partners which can be seen on the product pipeline on the company website.

    http://www.elitepharma.com/product_pipeline.asp

    By early 2011, the company was hitting on all cylinders. The company had achieved cash flow positive on the Lodrane Product revenues, had a promising pipeline of new products about to launch to add to revenues, was announcing joint development partners for other new products, and the stock price had risen from .04 to .20 and the future seemed bright. However, the FDA suddenly pulled 500 products from the USA market, including Elite's 4 Lodrane products, stating they hadn't submitted adequate studies to document the effectiveness of the products, and Elite lost it's entire product line. This was a major setback, of course, and Elite shares returned back to the .04 - .05 level.

    CEO Jerry Treppel, of course, was discouraged by this setback, but vowed to continue on the path he had mapped.

    In 2011 Elite launched phentermine tablets and once again became revenue producing. One of the Lodrane products was also re-launched in 2011. In 2012, Elite launched Methadone, Hydromorphone (generic Dilaudid), and phendimetrazine. The FDA also gave Elite approval to market 2 new capsule forms of phentermine in 2012, but the launch of these 2 products has been delayed until March 2013 because of a shortage of API (active pharmaceutical ingredient), which has since been corrected. Finally, the FDA granted approval for Elite to market Naltrexone tablets in 2013, and the company has stated these will launch in the second calendar quarter of 2013.

    This is now going to be a company with 8 drugs it is manufacturing for sale by itself and marketing partners in the USA. There are 2 more drugs (one to be marketed by Elite and one made for partner EPIC Pharma) that that are awaiting final FDA approvals. With 8 to 10 drugs selling on the USA Pharmaceutical market by year end, Elite will once again achieve Cash Flow Positive on operations. Remember, they had achieved this milestone previously with only 4 products.

    So with a stock price in the .08 to .09 cent range. Why would an investor be interested in Elite Pharma? It's a penny stock.

    My answer to that is that it's one of the most ethical penny stock companies ever to be found. Elite is FDA GMP (Good Manufacturing Practices) certified, and DEA registered for research and manufacturing of Controlled Substances. The company is still being operated like an AMEX company with quarterly investor earnings reports and conference calls, where any investor can call in and ask the company executives questions.

    Also since the company has patents in the Abuse Resistant Opioid (NYSE:ART) market, the stated goal is for the company to develop Patented products in this multi-billion dollar market. The millions they are currently making in revenues will potentially be replaced by a hundreds of millions to billions of dollar product(s). And just the first week of March, 2013 the company has received Notice of Allowance on another ART patent, which should come to final approval in mid-April 2013.

    The NOVEL asset sale:

    CEO Jerry Treppel has mentioned in a conference call late last year, that the company was considering monetizing their investment in Novel Labs, a private company, that now has grown to a much larger entity. It is carried on the Elite Pharma books at its original investment value of $3,329,322 which was the 2006 price that Elite paid for 10% ownership. Well, Novel Labs now has over 30 FDA approved products, and based on speculation comparable to other public companies of that size, the value of that investment could now be from 10 million dollars to 50 million dollars. If Elite is able to get this cash infusion with an asset sale, it will be able to pay the 4 million dollars in debt it has, and also be able to fund studies on it's ART products to enable it to grow much faster than it has in the past couple of years. Investors are excited about this source of funding as it will be non-dilutive, and if it comes in near the high range of estimate, could drive the company stock price much higher very quickly, as 50 million dollars is more than the 30 million dollar market cap of the entire company at the present time.

    Dilution and CEO funding

    Some detractors from the company have pointed out the dilution of Elite from 100 million shares to the current 357 million shares as of the latest SEC filing on Feb. 6, 2013. This would seem high until you look at the established companies in the drug industry, and realize that the norm for established companies is billion of shares.

    Here are a few examples,

    Pfizer- 7.36 billion shares

    Merck- 3.04 billion shares

    GlaxoSmithKline-2.41 billion shares

    Bristol-Myers 1.64 billion shares

    Abbot Labs 1.57 billion shares

    Lilly - 1.09 billion shares

    Mylan - .4 billion shares

    Elite Pharma - .356 billion shares

    CEO Jerry Treppel is concerned about dilution, and in an extraordinary show of that concern, has loaned the company 1 million dollars cash, dilution free, from his personal funds to keep research and operations going, until either some other funding source is obtained or the Novel asset sale is completed.

    http://ih.advfn.com/p.php?pid=nmona&article=55384279

    So to sum up:

    ELTP is now back in a position similar to early 2011 when the stock ran from .04 to .20 range. The current price near .09 reflects the current portfolio of 5 drugs already on the market, but doesn't reflect the impending launches of the next 3 drugs or the Novel asset sale.

    Some catalysts for the stock to move substantially higher in 2013 will be the announcement that Elite is once again cash flow positive on continuing operations, the announcement that a BIG PHARMA partner will commence the Phase III human studies needed to market a patented NDA drug in the billion dollar ART market, and an announcement that the Novel Asset Sale has now funded the company with tens of millions of dollars.

    Other positives will be the launch of drugs 9 and 10 onto the USA market later in the year, and the increase in earnings as all these products increase market share in their respective markets.

    The turnaround for Elite has been a long and bumpy road, but it appears that 2013 will see major milestones accomplished which should pay off for patient investors.

    Disclosure: I am long OTCQB:ELTP. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

    Themes: long-ideas Stocks: ELTP
Back To Drugdoctor's Instablog HomePage »

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Comments (21)
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  • dr_lowenstein
    , contributor
    Comments (7) | Send Message
     
    Thanks for an interesting article. I would like to comment on a few items that are, in my opinion, incorrect. First, this was not an IPO company but was a reverse merger. These types of companies have historically had difficulty with subsequent financings. Second, Treppel actually became a board member on Oct 28,2008 and CEO on Sept 9, 2009. At the time he became a director, the company had 1.5M in cash and positive working capital. When he became CEO, although cash had lowered considerably, the company still had positive working capital. In fact the threat of bankruptcy referred to occurred after the Sept 2010 NJEDA payment was missed. Finally the Lodrane removal in the spring of 2011 was fully 2.5 years after he became CEO. The SEC pointed out that this enforcement action began in 2006, thus it should not have been much of a surprise that such an action was possible
    10 Mar 2013, 05:59 PM Reply Like
  • hikeleader
    , contributor
    Comments (92) | Send Message
     
    No you are incorrect.

     

    He clearly was speaking in context of his coming onboard as CEO.

     

    "As the company was almost out of cash and could have faced possible bankruptcy, exit the previous CEO, and Jerry Treppel was hired as CEO. He came onboard in 2009 with a mission to turn the company around, and to become an operating, profitable, player in the USA Drug Industry. "

     

    Nice try as always.
    11 Mar 2013, 05:15 PM Reply Like
  • dr_lowenstein
    , contributor
    Comments (7) | Send Message
     
    Nice try to you as well. You should actually read what I posted:

     

    Elite Pharmaceuticals - Progress Report To Becoming Profitable In 2013 14 comments
    Mar 10, 2013 7:25 AM | about stocks: ELTP.OB

     

    Elite Pharmaceuticals (ELTP.OB) has made significant progress in executing on it's business plan in the past 2 years. The likelihood of Elite achieving cash flow positive by the end of 2013 is high, and will be detailed later in this article, but first a brief history of Elite Pharma and what it has taken to get to this point.

     

    Elite Pharma was originally an IPO company and traded on the AMEX stock exchange in the 2000's. Formed to research and develop abuse resistant opioid drug products, the company had some great ideas and had achieved some very good patents for drug products, two of which it was able to assign to Celgene Corp. for a fee. http://bit.ly/10EHos9

     

    ELTP began studies on it's patent pending, at the time, abuse resistant 2-bead technology, and was able to move through Phase 1 and Phase 2 FDA studies successfully, and at that point the money began to run out and ELTP needed a Big Pharma partner, to come in and fund the studies. With previous management leaving and the company in financial disarray, the stock price slipped below the $1 per share listing threshold on the AMEX and was re-listed on the OTCBB where it trades today. There was a lot more that happened, but history of Elite is not the purpose of this article.

     

    As the company was almost out of cash and could have faced possible bankruptcy, exit the previous CEO, and Jerry Treppel was hired as CEO. He came onboard in 2009 with a mission to turn the company around, and to become an operating, profitable, player in the USA Drug Industry. He was previously a director at AKORN Pharmaceuticals, which has been one of the stellar success stories in the USA Drug Industry in the past few years.

     

    Jerry Treppel's mission to turning the company around had 4 major steps.

     

    First- New funding had to be secured to keep the company operating and for it to acquire ANDA drugs to develop and market at it's facility. This funding was accomplished with a deal with a private company EPIC Pharma, which, though dilutive, injected millions of dollars into Elite by giving EPIC essentially almost half ownership of Elite.

     

    Second- Elite had to get some products on the market and begin to generate cash flow, which it did by marketing 4 products in the cold and allergy market, the Lodrane Products.

     

    Third- With a large portfolio of products under development, manufacturing capacity had to be increased, therefore facility capacity was doubled by the addition of a 15,000 square foot facility to the manufacturing capacity.

     

    Fourth- The company continues with its now patented abuse-resistant product development, and has some products in development by itself, and with some very large partners which can be seen on the product pipeline on the company website.

     

    http://bit.ly/Y6t4Ck

     

    By early 2011, the company was hitting on all cylinders. The company had achieved cash flow positive on the Lodrane Product revenues, had a promising pipeline of new products about to launch to add to revenues, was announcing joint development partners for other new products, and the stock price had risen from .04 to .20 and the future seemed bright. However, the FDA suddenly pulled 500 products from the USA market, including Elite's 4 Lodrane products, stating they hadn't submitted adequate studies to document the effectiveness of the products, and Elite lost it's entire product line. This was a major setback, of course, and Elite shares returned back to the .04 - .05 level.

     

    CEO Jerry Treppel, of course, was discouraged by this setback, but vowed to continue on the path he had mapped.

     

    In 2011 Elite launched phentermine tablets and once again became revenue producing. One of the Lodrane products was also re-launched in 2011. In 2012, Elite launched Methadone, Hydromorphone (generic Dilaudid), and phendimetrazine. The FDA also gave Elite approval to market 2 new capsule forms of phentermine in 2012, but the launch of these 2 products has been delayed until March 2013 because of a shortage of API (active pharmaceutical ingredient), which has since been corrected. Finally, the FDA granted approval for Elite to market Naltrexone tablets in 2013, and the company has stated these will launch in the second calendar quarter of 2013.

     

    This is now going to be a company with 8 drugs it is manufacturing for sale by itself and marketing partners in the USA. There are 2 more drugs (one to be marketed by Elite and one made for partner EPIC Pharma) that that are awaiting final FDA approvals. With 8 to 10 drugs selling on the USA Pharmaceutical market by year end, Elite will once again achieve Cash Flow Positive on operations. Remember, they had achieved this milestone previously with only 4 products.

     

    So with a stock price in the .08 to .09 cent range. Why would an investor be interested in Elite Pharma? It's a penny stock.

     

    My answer to that is that it's one of the most ethical penny stock companies ever to be found. Elite is FDA GMP (Good Manufacturing Practices) certified, and DEA registered for research and manufacturing of Controlled Substances. The company is still being operated like an AMEX company with quarterly investor earnings reports and conference calls, where any investor can call in and ask the company executives questions.

     

    Also since the company has patents in the Abuse Resistant Opioid (ART) market, the stated goal is for the company to develop Patented products in this multi-billion dollar market. The millions they are currently making in revenues will potentially be replaced by a hundreds of millions to billions of dollar product(s). And just the first week of March, 2013 the company has received Notice of Allowance on another ART patent, which should come to final approval in mid-April 2013.

     

    The NOVEL asset sale:

     

    CEO Jerry Treppel has mentioned in a conference call late last year, that the company was considering monetizing their investment in Novel Labs, a private company, that now has grown to a much larger entity. It is carried on the Elite Pharma books at its original investment value of $3,329,322 which was the 2006 price that Elite paid for 10% ownership. Well, Novel Labs now has over 30 FDA approved products, and based on speculation comparable to other public companies of that size, the value of that investment could now be from 10 million dollars to 50 million dollars. If Elite is able to get this cash infusion with an asset sale, it will be able to pay the 4 million dollars in debt it has, and also be able to fund studies on it's ART products to enable it to grow much faster than it has in the past couple of years. Investors are excited about this source of funding as it will be non-dilutive, and if it comes in near the high range of estimate, could drive the company stock price much higher very quickly, as 50 million dollars is more than the 30 million dollar market cap of the entire company at the present time.

     

    Dilution and CEO funding

     

    Some detractors from the company have pointed out the dilution of Elite from 100 million shares to the current 357 million shares as of the latest SEC filing on Feb. 6, 2013. This would seem high until you look at the established companies in the drug industry, and realize that the norm for established companies is billion of shares.

     

    Here are a few examples,

     

    Pfizer- 7.36 billion shares

     

    Merck- 3.04 billion shares

     

    GlaxoSmithKline-2.41 billion shares

     

    Bristol-Myers 1.64 billion shares

     

    Abbot Labs 1.57 billion shares

     

    Lilly - 1.09 billion shares

     

    Mylan - .4 billion shares

     

    Elite Pharma - .356 billion shares

     

    CEO Jerry Treppel is concerned about dilution, and in an extraordinary show of that concern, has loaned the company 1 million dollars cash, dilution free, from his personal funds to keep research and operations going, until either some other funding source is obtained or the Novel asset sale is completed.

     

    http://bit.ly/10EHmAD

     

    So to sum up:

     

    ELTP is now back in a position similar to early 2011 when the stock ran from .04 to .20 range. The current price near .09 reflects the current portfolio of 5 drugs already on the market, but doesn't reflect the impending launches of the next 3 drugs or the Novel asset sale.

     

    Some catalysts for the stock to move substantially higher in 2013 will be the announcement that Elite is once again cash flow positive on continuing operations, the announcement that a BIG PHARMA partner will commence the Phase III human studies needed to market a patented NDA drug in the billion dollar ART market, and an announcement that the Novel Asset Sale has now funded the company with tens of millions of dollars.

     

    Other positives will be the launch of drugs 9 and 10 onto the USA market later in the year, and the increase in earnings as all these products increase market share in their respective markets.

     

    The turnaround for Elite has been a long and bumpy road, but it appears that 2013 will see major milestones accomplished which should pay off for patient investors.

     

    Disclosure: I am long ELTP.OB. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
    Themes: long-ideas Stocks: ELTP.OB

     

    Back To Drugdoctor's Instablog HomePage »

     

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    dr_lowenstein Comments (3)

     

    Thanks for an interesting article. I would like to comment on a few items that are, in my opinion, incorrect. First, this was not an IPO company but was a reverse merger. These types of companies have historically had difficulty with subsequent financings. Second, Treppel actually became a board member on Oct 28,2008 and CEO on Sept 9, 2009. At the time he became a director, the company had 1.5M in cash and positive working capital. When he became CEO, although cash had lowered considerably, the company still had positive working capital. In fact the threat of bankruptcy referred to occurred after the Sept 2010 NJEDA payment was missed.
    11 Mar 2013, 05:24 PM Reply Like
  • hikeleader
    , contributor
    Comments (92) | Send Message
     
    I actually did. You as always just choose to pretend otherwise.
    11 Mar 2013, 07:07 PM Reply Like
  • dr_lowenstein
    , contributor
    Comments (7) | Send Message
     
    A couple of other things to note about the company:
    1. They are in default of their NJEDA debt obligations
    2. They have little cash and have negative working capital
    3. They disclose in their SEC filings that they have inadequate financial controls

     

    These matters can be resolved but have lingered for quite a while.
    10 Mar 2013, 10:31 PM Reply Like
  • Couch
    , contributor
    Comments (47) | Send Message
     
    Thanks for a well informed and researched article Drugdoctor. I've been invested in this company for two years now and continue to add to my already sizable share count on a regular basis. At these prices and with their pipeline shares are a no brainer right now IMO!

     

    Additionally, the Abuse Resistant Opioid Market is a Multi Billion Dollar one and there are only five Abuse Resistant Products on the market as Pfizer had Embeda pulled over two years ago for stability issues and they have not been able to rectify their stability issue to date. Elite only needs one Abuse Resistant Product on the market for the company to be an amazing turnaround story. As you will see this looks doable in the not too distant future.

     

    Here are a few quotes from Elite's recent conference call on Feb. 19, 2013 attesting to their current success: The Second one is from their CEO Jerry Treppel.

     

    "So comparing revenues from a quarter one year ago, manufacturing revenues have increased over 200% and royalty revenues have increased more than 700%. Clearly, Elite is growing substantially as we continue to add products. Elite is preparing to launch three new products for its portfolio, two strengths of the Phentermine capsules and an Naltrexone tablet product."

     

    "At this point at least one of those products is reaching the point where we expect it will go into clinical trials relatively near future.

     

    It’s interesting to me that someone who worked on Wall Street for 25 years and disparity in valuation between companies like Elite and other companies involved in development of abuse-resistant products like Pain Therapeutics, Acura, what it says to me is that, the investment community doesn’t really believe us yet, but these products are going to be real. Well, there is lot of people in this company including myself and Chris and Carter, and our Chief Scientific Officer who have been paid a significant amount of stock because we do believe that. And that market has developed in a way enormously to our advantage, and we think we have an officious technology that is in a lot of ways superior to approaches that other companies are taking."
    11 Mar 2013, 05:13 AM Reply Like
  • Couch
    , contributor
    Comments (47) | Send Message
     
    Great Article and a few complimentary pieces of information from Elite's most recent Conference Call Feb. 19, 2013
    1. So comparing revenues from a quarter one year ago, manufacturing revenues have increased over 200% and royalty revenues have increased more than 700%. Clearly, Elite is growing substantially as we continue to add products. Elite is preparing to launch three new products for its portfolio, two strengths of the Phentermine capsules and an Naltrexone tablet product.

     

    2) At this point at least one of those products is reaching the point where we expect it will go into clinical trials relatively near future.

     

    It’s interesting to me that someone who worked on Wall Street for 25 years and disparity in valuation between companies like Elite and other companies involved in development of abuse-resistant products like Pain Therapeutics, Acura, what it says to me is that, the investment community doesn’t really believe us yet, but these products are going to be real. Well, there is lot of people in this company including myself and Chris and Carter, and our Chief Scientific Officer who have been paid a significant amount of stock because we do believe that. And that market has developed in a way enormously to our advantage, and we think we have an officious technology that is in a lot of ways superior to approaches that other companies are taking.
    11 Mar 2013, 05:45 AM Reply Like
  • Drugdoctor
    , contributor
    Comments (19) | Send Message
     
    Author’s reply » Yes, but the NJEDA debt is not a concern to the issuer, the State of New Jersey, as they just funded hundreds of thousands of more dollars to Elite this year. As long as the interest on the loans is paid, which it has been every quarter, NJEDA is not calling the loans.
    And when the NOVEL asset sale goes through, there will be more than enough cash on hand to fund the New Drug studies and pay off the New Jersey debt completely.

     

    They have large receivables on the books, CEO funding, and new funding about to be announced... Funding is not an issue at this time..

     

    The financial controls have been discussed with the SEC and are not an issue at this time.

     

    The successful launch of the next 3 drugs is the short term issue we are watching, and that success should drive the company to profitable operations, in the next couple of reporting periods.
    11 Mar 2013, 05:49 AM Reply Like
  • IB_
    , contributor
    Comments (24) | Send Message
     
    To list Elite with Pfizer, Merck, etc. is nothing short of ridiculous !!
    11 Mar 2013, 05:59 AM Reply Like
  • Couch
    , contributor
    Comments (47) | Send Message
     
    Not ridiculous at all. It seems others as well have listed Elite alongside the major players in the Chronic Pain Opioid space such as Pfizer, Endo, Johnson and Johnson, Abbott Labs, etc.
    Take a look:
    1) Research and Markets: Chronic Pain Therapeutics Market Is Forecast To Show Slow Growth until 2017 When It Will Reach $24.9 Billion.
    http://bit.ly/12HDMXB
    Changing Future Landscape of the Chronic Pain Therapeutics Market

     

    Pfizer Inc., Grunenthal GmbH, Cephalon Inc., SantoSolve AS, Transdel Pharmaceuticals, WEX Pharmaceuticals, Avanir Pharmaceuticals, Elite Pharmaceuticals, Horizon Therapeutics, Insys Therapeutics and Endo Pharmaceuticals are going to be the key players in future. GlobalData has profiled of all these companies as they hold important pipeline drugs in late stage development for chronic pain.

     

    2) Osteoarthritis (OA) Pain Therapeutics - Pipeline Assessment and Market Forecasts to 2017
    http://bit.ly/YSdSv9

     

    Abbott Laboratories, Adolor Corporation, Cephalon, Inc., Endo Pharmaceuticals, Elite Pharmaceuticals, Glenmark Pharmaceuticals, Grunenthal GMBH, Johnson & Johnson Pharmaceuticals Ltd., Pfizer, Inc., SantaSolve AS, and Sanofi-aventis are going to be the key players in the OA pain market. GlobalData has profiles of all these companies as they hold important pipeline drugs in late stage development for OA Pain treatment.
    11 Mar 2013, 07:24 AM Reply Like
  • IB_
    , contributor
    Comments (24) | Send Message
     
    Yes Charlie, "ridiculous" !!!!
    20 Apr 2013, 07:07 AM Reply Like
  • investor_pro
    , contributor
    Comment (1) | Send Message
     
    Great article. I've done a lot a research on this company and the current value is forecasted to significantly increase. Thanks for such a thorough review.
    11 Mar 2013, 06:12 AM Reply Like
  • Investing services
    , contributor
    Comments (24) | Send Message
     
    Also important to note the company once traded on the AMEX and almost went bankrupt until Epic stepped in. That was 2008 time frame. Not sure what the reply is trying to say about reverse mergers or IPOs. The company has been around almost 20 years, put 100 million dollars into R&D. their Chief scientific officer is the president of Epic pharma. The tech works and is not complicated to understand and the market for abuse resistant pain killers has never been bigger. Investors are getting all that investment now for a drastically reduced price.
    11 Mar 2013, 06:17 AM Reply Like
  • hakujin
    , contributor
    Comments (130) | Send Message
     
    wow's you've been pumping this downhill train wreck for quite some time sir.
    11 May 2013, 01:11 AM Reply Like
  • Drugdoctor
    , contributor
    Comments (19) | Send Message
     
    Author’s reply » Well, looks like ELTP was a better investment in 2013 than S&P 500 index funds. I believe we go much higher in 2014 with our new CEO Nasrat Hakim, and Camargo's explosive move into human studies already started. The train has turned into a rocket, and is on the launchpad... Got ELTP? You know I do!
    8 Dec 2013, 11:16 AM Reply Like
  • Drugdoctor
    , contributor
    Comments (19) | Send Message
     
    Author’s reply » Points well taken, but in the Pharmaceutical Industry, 1.5 million dollars is not enough cash to develop products and keep operations funded until cash flow positive. Credit CEO Jerry Treppel for putting together the 3 million dollar EPIC Pharma funding, then getting continuing State of New Jersey Loans from their Business Development project. The Novel Asset Sale will wipe all debt off the books and give ELTP millions of dollars in additional funding to complete it's ongoing ANDA and NDA product development and launches. Finally, no one believed the FDA would suddenly yank 500 products off the market in one day. That it was a surprise is a fact.

     

    But all that is past history, which is why the stock trades at a mere .09 per share. My point is that in 2013 the company will have 8 to 10 USA Pharmaceutical products on the market and will be cash flow positive, and if/when the Novel asset sale goes through, will be totally funded for studies and debt free. The launch of the next 2 phentermine drugs may indeed come as early as this week, week ending 3/15/13, the Novel Asset Sale announced at any time, and the newest Abuse Resistant Patent will be finalized in Mid-April, followed by the launch of Naltrexone Tablets. That is why many investors are now very excited about the remainder of 2013 for their ELTP shares.
    11 Mar 2013, 06:18 AM Reply Like
  • Investing services
    , contributor
    Comments (24) | Send Message
     
    The above reply to this factual article is actually not factual at all. Lets see where to begin...

     

    Lodrane - This is HITK/ECRs drug - Elite developed and manufactured it for them. HITK was notified in 2010 when they began to prepare the FDA requirements for approval. Not 2006 and it wasn't Elite's drug. This can be found in both HITKs and ELTPs filings. So to blame the CEO of Elite doesn't make any sense here and the timeline is about 4 years off. Elite has been supporting HITK with everything they have required to submit to the FDA to gain approval from the FDA.

     

    The 1.5 million positive working capital was from the Epic strategic Alliance. Elite has partnered with some of the largest players in the industry including. Watson. Epic is a massive contract manufacturing company for Sandoz and was at one time the largest contract drug manufacturer for a single company and may still be. The 1.5 million went to get more drugs to launch for Elite.

     

    Elite is about to launch the last 2 of these products with an IMS number in excess of 60 million dollars. Naltrexone and Phentermine 15mg and 30mg. The 15mg is 1/2 of the generic of the billion dollar projected drug Qysmia.

     

    Elite has never been cashflow positive outside of 2 Qs right before Lodrane was pulled. They will shortly have 8 drugs launched, from 0 drugs when Lodrane was pulled. This was done in about 18months and they are about to cash flow positive again.

     

    The NJEDA item is several years old and Elite submitted a proposal to NJEDA to restructure their deal. However since Elite continues to pay the interest on the deal, it is not expected that NJEDA will vote anytime soon since they continue to get paid.

     

    The interesting thing about their proposal to NJEDA is they proposed to pay off all their debt of about 3.5 dollars in one shot this year. That is Elite's total debt. How can that be possible?

     

    Elite owns 10% of Novel. They invested 7m dollars in 2006. That investment is worth somewhere between 10-50 million dollars. Novel has about 32 commercial drugs including their very recent approval of the "plan B" pill which is an 88 million dollar drug with two other competitors. Elite owns 10% of this company.

     

    How many penny stocks own 10% of a company like Novel? The owner of Novel sold his last two companies for an estimated 130 million and 450 million dollars.

     

    The CEO has since put 1 million dollars via unsecured loan to support their R&D efforts.

     

    All of this is great but where is the homerun? Elite's primary focus has mostly been in the field of abuse resistant opioids. Having completed PH1 and PH2 for abuse resistant Oxycontin, Elite is pushing toward completing trials now for additional products. These products are held closely to the vest for competitive reasons but the CEO put it best.

     

    "It’s interesting to me that someone who worked on Wall Street for 25 years and disparity in valuation between companies like Elite and other companies involved in development of abuse-resistant products like Pain Therapeutics, Acura, what it says to me is that, the investment community doesn’t really believe us yet, but these products are going to be real. Well, there is lot of people in this company including myself and Chris and Carter, and our Chief Scientific Officer who have been paid a significant amount of stock because we do believe that. And that market has developed in a way enormously to our advantage, and we think we have an officious technology that is in a lot of ways superior to approaches that other companies are taking"
    11 Mar 2013, 06:21 AM Reply Like
  • dr_lowenstein
    , contributor
    Comments (7) | Send Message
     
    Actually, your facts are wrong. The 1.5M in cash is from Sept 30, 2008, immediately prior to JT joining the board. The Epic deal was not done until March 18, 2009. As for the Lodrane situation, the FDA announced the enforcement action in 2006. It is not reasonable to claim that Elite had no responsibility. Yes, it was marketed by ECR, but was DEVELOPED and MANUFACTURED by Elite and in fact was essentially their only source of revenue, so it might have been prudent to be aware of pending regulatory action. no?
    11 Mar 2013, 04:17 PM Reply Like
  • Drugdoctor
    , contributor
    Comments (19) | Send Message
     
    Author’s reply » Update- 8 insider BUYS form 4's filed today from CEO, President, and CFO on down.... today. These buys would indicated to me that they consider the shares undervalued and are adding themselves in the .08 range.
    12 Mar 2013, 06:00 AM Reply Like
  • hikeleader
    , contributor
    Comments (92) | Send Message
     
    No, those were annual awards of stock, not outright buys.
    12 Mar 2013, 09:01 AM Reply Like
  • dr_lowenstein
    , contributor
    Comments (7) | Send Message
     
    They were not buys- they were annual compensation awards.
    12 Mar 2013, 12:34 PM Reply Like
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