They have been hiring a bunch of folks ~30% increase over the past 6 months or so
Just noted in the PR that that the second 15k facility is ready to go for mfg and packaging.
Bigger batches of Phenetermine and Methadone will be made there
5 products pending FDA approval right now and 3 were from the same inspections as the facility approvals. LOL LOL
And then there is all this
Breakdown of Known Upcoming Catalysts
Naltrexone Approval and then Launch Undisclosed Opioid ANDA – 80m generic – Approval and then Launch Phendimetrazine ANDA 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
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
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
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/
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.