FDA Forward-Looking Events

[senderos]

Elite Pharmaceuticals: www.elitepharma.com/

Many of us have owned and followed ELTP for more than a year. It had some major upsets several years ago and was managed poorly, almost went bankrupt, and then was taken over by new management. Their progress over the past couple of years has been dramatic, and they should be cash-flow positive within a couple more quarters.

Below, I have pasted a post by "tangerine" from the ELTP board, which summarizes the upcoming catalysts. This is not pie in the sky stuff. There is little doubt that most or all of this will happen, but I will make no predictions on the timeline. Their opioid-resistant technology, for which they now have a patent, will be a game changer for the entire industry.

From ELTP board:

Breakdown of Known Upcoming Catalysts

Naltrexone Approval and then Launch
Phentermine 15mg and 30mg Launch –
Phendimetrazine Approval and then Launch
Approval of second Manufacturing Facility
New Financing deal
Approval of Epics first of 8 products
Additional Opioid ANDA is pending approval
Patent Pending Approval - 12/640,344 – Abuse resistance
Patent Pending Approval - 13/379,486 – Micro-Tabets - .25mm – 1mm – All types of medications
Patent Pending Approval - 13/379,481 – Use of the Micro-tablets to make abuse resistant products
Approval and Launch of HITKs generic of a 100m branded product
Approval and Launch of MIK001
Approval and Launch of HK Pharma product
Return of Lodrane
2nd Quarter revenue will show ~200% increase over the previous year
Profitability – Elite expects to hit cash flow neutral/positive in the 4th quarter this year.
Anything to do with a sale of Novel Labs – Elite Owns 10%
Anything to do with the closing of Elite’s debt issue with NJEDA



Naltrexone Approval – Way over due - Was part of the now completed inspections from about 1 month ago and noted on the CC– Was part of the deal along with the now approved Hydromorphone and was forced to undergo the same change of facility nonsense. $12m generic on the drug shortage list with few competitors. Market has likely grown as new uses are being discovered and tested for everything from AIDS, Parkinson’s and Crohn’s disease.
http://money.cnn.com/news/newsfeeds/articles/globenewswire/200584.htm
http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm314741.htm
http://www.lowdosenaltrexone.org/

Undisclosed Opioid ANDA – Way overdue - Also from the same timeframe and completed inspections as above as discussed on the CC. Based on some subtraction using the data in the PRs, this looks like an 80m Generic Opioid
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=79189212

Phendimetrazine ANDA Approval – Way overdue - This product has been undergoing transfer of facility too, and for a long time. Also part of the recently completed inspections as noted on the CC call. This product is being marketed by Actavis through their designee Mikah. YES THAT ACTAVIS!! Revenue on this product only shows $3m from the best old data I can fine. It is a diet drug for obesity and it is all over the web despite very, very few manufacturers. I think this was also USA only and Actavis is worldwide. Lots of questions here but the partner is absolutely huge. I believe Elite has paid all the up-front costs here and will receive a milestone payment once the approval is complete. If you click on the link, you will see many manufacturers but almost all of these have discontinued production some time ago.
http://www.globenewswire.com/newsroom/news.html?d=223706
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Approval of second Manufacturing Facility – Way overdue - This is the second 15k square foot facility to manufacture FDA, DEA approved controlled substances. Equipment has been deployed, warehousing is available for use and I believe the packaging line is also pending approval here but that may already be approved. This will lower Elite’s costs in several ways and of course be needed because of all the products as they go from 4 to 7 to 9 to 12 FDA approved products. Also this approval will include allowing Phentermine and Methadone to me made there so that much larger batches can be made. As noted on the CC, these products are growing rapidly, especially Phentermine so this will lower costs and increase profits as will Elite handling all their own packaging.

Financing Deal Is expected soon whether it be Socius or another structure as noted on the CCs. CFO stated “Expect something in the near future." That was some time ago. This money will likely go to more Studies and Trials. Seems the loan from the CEO is sufficient for now per the President of Elite.

Epics 1st or 8 Products is pending approval – We don’t know what this product is yet but I suspect it will be marketed through TAGI Pharma

Additional Opioid ANDA is pending approval – This has been pending for some time. We don’t know much about it except it’s another opioid/controlled substance.
Launch of the 5 Drugs listed above approximately 1-3 months from approval

Patent Pending Approval

12/640,344 – Second abuse resistance patent – This one is likely to be approved soon based on the non-final rejection. Seems like a formality at this point.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=79335188

13/379,486 – Micro-tablets down to .25mm size. This is for dozens and dozens medications. Sent up to examiner for review/approval

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=79310230

13/379,481 – Use of the Micro-tablets to make abuse resistant products

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=79271751

Approval and Launch of HITKs generic of a 100m branded product
In scale-up and almost 2 years in the works
http://www.globenewswire.com/newsroom/news.html?d=210753

Approval and Launch of MIK001 – This is an NDA in the works for Mikah/Actavis – yes again that Actavis!! Timeline is tough to know here. This has been in the works for quite some time
“Mikah Pharma has contracted Elite Pharmaceuticals to develop and manufacture our top leading products. Elite will develop MIK001’s formulation, analytical methodology, and manufacture, test and release the clinical supplies necessary for our clinical trials and NDA approval.”
http://www.mikahpharma.com/index_files/pProducts.htm

Approval and Launch of HK Pharma product – This is an NDA being developed by Elite for a Hong Kong Pharma company. This seems to be an opioid, approved and marketed overseas being launched in the United States
http://www.globenewswire.com/newsroom/news.html?d=250006

Return of Lodrane – The latest info is that ECR is still dealing with the FDA and cannot provide a launch date. Elite was profitable on Just Lodrane 2011
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=79216213

2nd Quarter revenue will show ~200% increase over the previous year. I believe revenue was ~278k one year ago. Last Q was 578k and increasing as the 4 products grow. Manufacturing revenues grew 20% over previous Q which would be ~$700k. If they continue to grow at that rate as they are all just getting established and Elite gets a milestone payment for Phendimetrazine, they should hit ~750k on revenue. If Elite launches another product, they will go over that number.

Phentermine - Launched - April 2011
Hydromorphone - Launched March 2012
Methadone - Launched Jan 2012
Lodrane D - Launched Aug 2011

Note: Phentermine Sales rapidly growing and larger batches will be made in new facility pending approval now. Same with Methadone.

Isradipine Approval and Launch – Also with Mikah/Actavis

Profitability – Elite expects to hit cash flow neutral/positive in the 4th quarter this year. With 7 or more products and only being 400k this past quarter from that number and 4 relatively new and growing FDA approved generic drugs, it is easy to see why the CEO thinks this will happen. This does not include any monies spent on the BE studies for the abuse resistant product line.

Anything to do with a sale of Novel Labs – Elite Owns 10% - Here is some info on Novel Labs
http://www.novellabs.net/

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=79145196


Anything to do with the closing of Elite’s debt issue with NJEDA
– Elite has been in default on the NJEDA loan – This is with the state of NJ. They have been making the interest payments and replenishing the debt reserve which they are allowed to do. They have also waited for a response for a long, long time now on a plan they submitted. I think NJ is content to continue to continue to get their interest payments. The total debt is only 3.3m and the principal owed is something like 700k. I believe the plan was to repay the entire debt in 2013. That was about 4 conference calls ago.