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.
Maybe we can look into this as a case history of sorts...
http://www.intellipharmaceutics.com/releasedetail.cfm?ReleaseID=623843
November 15, 2011
Intellipharmaceutics' Manufacturing Facility Passes FDA cGMP and Pre-Approval Inspection
How long after this announcement did they begin seeing product approvals?
Return of Extended Release Lodrane w/ ECR just mentioned among the many pipeline items ... it was mentioned alonog with the Mikah Undisclosed ANDA as "Medium to Long Term"
I don't recall any specific mention of BE studies.
Yes, they said can package the Lodrane product using it.
ok, very quick CC.
Takeaways:
Per Carter (CFO) regarding financing "Expect something in near future...."
Per JT (CEO) regarding dilution: "coming to an end" / a little bit of series C and series E (Epic) left to convert.
Per JT (CEO) regarding having a DEA facility (paraphrasing here) "very valuable" "can not import controlled substances" "this is why we have so many talking to us about partnering"
The most recent ANDA (Hong Kong?) is indeed for a controlled substance
Expectations for FDA approval following the inspections recently completed "hope not too distant future"
0.0952
Yuk!
You want each products sales for each of the last 4 quarters?
You want that in a bar graph or line graph?
What font would you like it in?
Not really down 30% in a week. Close 8/7 was 0.1099, today was .1040. That is a 5% drop.
Phentermine:
Elite’s revenue derived from phentermine 37.5mg tablets during the three months ended June 30, 2012 and 2011 were approximately $162k and $217k, respectively, with such amounts including manufacturing revenues, royalties and a $145k milestone payment triggered by the shipment of the product in April 2011.
Take the 145k out of the 2011 number they went from 72k to 217k
Lodrane:
Elite’s revenue derived from Lodrane D® during the three months ended June 30, 2012 and 2011 were approximately $142k and zero, respectively.
Methadone:
Elite’s revenues derived from the contract manufacture of Methadone 10mg tablets during the three months ended June 30, 2012 and 2011 were approximately $128k and zero, respectively.
Hydromorphone:
Elite’s revenues derived from Hydromorphone 8mg tablets during the three months ended June 30, 2012 and 2011 were approximately $78k and zero, respectively, with such amounts including manufacturing revenues and royalties paid pursuant to the Precision Dose Agreement.
All combined they went from: 72k to 565k (In one quarter) on these four items since last year.
Total Revenues 578,556
ECR Pharmaceuticals Overview
?
Branded specialty pharmaceutical company that promotes prescription products to Physicians and Pharmacists
?
70 field representatives concentrated in 16 mid-Atlantic and southern states
?
Continuing product lines:
?
DexPak® line: Dexamethasone for treatment of dermatitis/poison ivy
?
Bupap®: treatment of tension headache
?
Lodrane® – to be launched as 12 hour OTC pending approval
Good find by YMB poster...
http://elitepharma.com/product_pipeline.asp
*NEW* Abuse Resistant Slide Updated 9-Aug-12 03:47 pm
They updated the slide on Elite's website.
It no longer says "How ELI-216 works". They changed it to "How abuse resistant technology works".
They also changed the slide from "oxycodone" to "opioid" because this tech can be applied to all opioids.
https://docs.google.com/open?id=0BwI9WYgqHk9mSW5CZXdhVkkxdXc
These are the slides. I don't know if the audio is still available.
Also points this out....
The bill would give FDA authority to yank regulatory approval for generic drugs that aren't redesigned with their own safety features. The agency has already been considering whether to require generic painkillers to be tamper-resistant, The Wall Street Journal reports, partly because OxyContin and Opana fall off patent next year.
Some stuff about the Bond...
From 2005
http://www.neptunecompany.com/img/bonds/series/1815/MS76409-MS26565-MD51084.pdf
About Refunded Bonds
http://financial-dictionary.thefreedictionary.com/Refunded+Bond
From 1999:
http://web.ebscohost.com/ehost/detail?sid=3fd59c07-4028-4a26-8769-5cfa0e02e0a9%40sessionmgr10&vid=1&hid=12&bdata=JmF1dGh0eXBlPWdlbyZnZW9jdXN0aWQ9Y2pybGMwODUmc2l0ZT1laG9zdC1saXZl#db=bsh&AN=2280948
Section: Washington
High-Yield Focus
N.J. DRUG COMPANY GIVES MARKET A NONRATED PRESCRIPTION
Eager for a dose of high-yield paper, a handful of sophisticated retail investors and one large institutional account snapped up a $3 million nonrated offering last week from a pharmaceutical company.
The deal, sold last Tuesday through the New Jersey Economic Development Authority, will finance the construction of a new manufacturing plant in Northvale on behalf of Elite Pharmaceutical Inc., whose stock market ticker is ELIP.
In this instance, as it has in others, the EDA serves as a conduit issuer for manufacturing companies if their bond proceeds finance New Jersey-based projects.
Elite decided to tap the municipal market for its financing as an alternative to paying in excess of 12% for a conventional bank loan.
As a result, the issue brought to the tax-exempt market a much-needed prescription for high-yield paper at a time when the supply of nonrated offerings is on the light side, according to Dean Myerow, managing partner and trader at Bergen Capital Inc. in Hasbrouck Heights, N.J.
The firm placed the entire deal in just one day after it was oversubscribed by one and half times, said Charlie Gilbride, president of the six-month-old investment firm.
But high-net-worth retail investors and a large New York money manager bought the issue for several reasons besides the 7 3/4% coupon due in 2014 priced at par.
Investors were also comfortable with the fact that Elite is a $52 million, publicly traded company that can be easily tracked on the Internet, Myerow pointed out.
Among the other selling points, he cited a first mortgage pledge on the property, the manufacturing plant, and its equipment -- a total asset value of $4.3 million which more than adequately covers the principle amount of the issue.
In addition, the bonds offer six years of call protection and are considered a general obligation of the company.
Elite specializes in the formation and development of controlled, delayed-release tablets and capsules, and recently obtained a patent for a pulse release form of methylphenidate, which is widely marketed under the name Ritalin.
The company is seeking approval from the Food & Drug Administration on six different drugs -- including products for treating cardiovascular disease, arthritis, and diabetes -- and has assisted in developing similar products for such well-known companies as Smithkline-Beecham and Novo-Nordisk.
GRAPH: N.J. Economic Development Authority: Recent Issuance
Sent her an email last night. I await her reply.
Lasers
Volume of response does not equate to accuracy.
I'll ask Dianne.
Lasers:
Perhaps allow for the possibility that Elite takes the purchased raw material in powder form and "manufactures" the tablet.
It was. Clearly an error in the transcribing.
After great success, we experienced an unexpected setback, but we have always stuck to that plan, because that plan works
The patent, just to be clear, is a generalized approach to how to develop an abuse resistant product. It's important to remember
that it's not specific to any one product. It can be used basically for any opioid.
but the most important reason for shareholders is that we will no
longer be issuing dividends to those preferred shareholders, which means less dilution for common shareholders. We think that's a good thing.
Chris Dick - Elite Pharmaceuticals, Inc. - COO and President
First of all, Socius -- we may do it with Socius; we may do a different deal. We are evaluating alternatives, so that's open.
But the opportunities with abuse resistant sort of span a range of ANDAs to NDAs and bioequivalent studies to full efficacy studies, so it allows us to do the ANDA opportunities -- some of the ANDA opportunities and even a 505(b)(2) opportunity. And so we can certainly, I think, handle those things in-house if we raise this money through Socius.
The second plant -- when you see that coming online, and which products are you looking to push out of there?
Chris Dick - Elite Pharmaceuticals, Inc. - COO and President
It's really dependent on how quickly -- it does have to be reviewed and approved by the FDA, so it's kind of a question of how long it takes them to come in to look at it, and it's really -- it's hard for me to say what that is. But it's a matter of a few months, is our expectation.
Jerry Treppel - Elite Pharmaceuticals, Inc. - Chairman and CEO
Full disclosure here. There's no question that the issuance of that patent has piqued the industry's interest. Okay? And we know that from the calls that we get.
But, as I said before, piquing interest is not the same thing as I want to sit down and discuss terms with you. And we think in order for that to happen, as Chris just said, you have got to demonstrate to people that I can commercially make -- scale it up; I've done the biostudies; I have a product.
Okay? And that's our goal, and we will get there in this fiscal year.
but generally under most reasonable scenarios, right around the $4 million run rate is where we turn cash flow positive.
We are expecting to reach those levels where we were once at by the end of this fiscal year. So roughly 9 months or so from now is what we are expecting as far as reaching the levels that we were at prior to the Lodrane being removed.
Jerry Treppel - Elite Pharmaceuticals, Inc. - Chairman and CEO
Well, as you know -- you read the deal. It's a complex deal. There were just aspects of it -- their issue revolved around issuing a note versus stock for certain aspects of it. I mean, frankly, if you were able to look at the new structure that they are okay with, it's not a heck of a lot different. Okay?
It's more semantics than anything else.
But that's the way they are. So fine. And in terms of economics of the deal, they haven't changed at all. So someone there felt like they had to do something that day.
Carter Ward - Elite Pharmaceuticals, Inc. - CFO
I mean, really, (technical difficulty) is that the problem with the deal was really some very technical SEC legal issues, which made it clear to us that the S-1 wouldn't -- was not going to be approved. And so it was just in the best interest of everybody involved for us to request that that S-1 be withdrawn.
There are alternate deal structures which are essentially the same from an economic standpoint, but that address these very technical legal issues in a different way which are acceptable. So that's where we are at right now.
Carter Ward - Elite Pharmaceuticals, Inc. - CFO
The common stock -- there's really no effect, per se, to the common stock. What is, I think, a positive is that now there's a lot -- the ownership and the control of Epic, who is our major investor, our biggest investor and our strategic partner, is now concentrated in the hands of the people that are sitting on our Board as well.
So there's no more -- other investors that they have to be concerned about. These directors and owners of Epic now can just be concerned about Elite itself and that impact, instead of having to deal with any other issue which may apply from some other investor who could have different agenda than just Elite's. So, yes, it is a positive.
Jerry Treppel - Elite Pharmaceuticals, Inc. - Chairman and CEO
Let's be straight up and frank here, okay? When Epic invested, it was through Epic Partners, which included non-Epic people. Okay? Not a majority,but there were some.
When investment was made, it was a three-year holding period. That three-year holding period expired. Those investors are in at a very good price; they've made a lot of money, and some of them wanted to take the money -- their profits. Fine. Okay?
Unidentified Participant
What's the chances of getting Epic to fund some of these trials? I mean, if they're a partner here --
Jerry Treppel - Elite Pharmaceuticals, Inc. - Chairman and CEO
It's an interesting question. The most we can say about it right now is that we talk about it.
Jerry Treppel - Elite Pharmaceuticals, Inc. - Chairman and CEO
What we've done is just separate them into two different beads. I mean, that's why we are excited about it. It's different. Quite frankly, it's much more straightforward, and it uses the pharmacologic approach, which clearly the FDA likes the best, because it's understandable in terms of the science. Okay?
You don't get high, because the agonist competes with the opioid for the receptors on the brain. Okay? Again, straightforward theory.
Since I paid for the transcript (again!) I will cut and paste my favorite comments:
For starters:
Chris Dick - Elite Pharmaceuticals, Inc. - COO and President
Yes, you have to understand that ours is a two bead product as opposed to the others that are one bead products, so ours is much more modular.
So we have our abuse resistant bead, and then we can combine that with any other opiate bead in the same capsule, whereas if you were --according to your comment regarding Embeda, you would have to figure out a way to put a different active onto that same bead, which is -- it's not impossible, but it's much more difficult.
Unidentified Participant
Okay. So it truly is in a unique and different direction and approach that is solely proprietary now and patented to Elite.
Chris Dick - Elite Pharmaceuticals, Inc. - COO and President
Absolutely. I mean, that's why the patent was allowed and issued.
Companies subject to Action:
Warning Letters
Boehringer Ingelheim Roxane, Inc.
Boehringer Ingelheim Roxane, Inc. Follow-Up letter, 3/1/2010 (PDF - 33KB)
Boehringer Ingelheim Roxane, Inc. Follow-Up letter, 4/9/2009 (PDF - 30KB)
Cody Laboratories, Inc.
Cody Laboratories, Inc. Follow-Up letter, 3/1/2010 (PDF - 33KB)
Cody Laboratories, Inc. Follow-Up letter, 4/9/2009 (PDF - 30KB)
Glenmark Generics Inc.
Glenmark Generics, Inc. Follow-Up letter, 3/1/2010 (PDF - 33KB)
Glenmark Generics, Inc. Follow-Up letter, 4/9/2009 (PDF - 30KB)
Lannett Company, Inc.
Lannett Company, Inc. Follow-Up letter, 3/1/2010 (PDF - 33KB)
Lannett Company, Inc. Follow-Up letter, 4/9/2009 (PDF - 30KB)
Lehigh Valley Technologies, Inc.
Lehigh Valley Technologies, Inc. Follow-Up letter, 3/1/2010 (PDF - 34KB)
Lehigh Valley Technologies, Inc. Follow-Up letter, 4/9/2009 (PDF - 30KB)
Mallinckrodt Inc. Pharmaceuticals Group
Mallinckrodt, Inc. Pharmaceuticals Group Follow-Up letter, 3/1/2010 (PDF - 24KB)
Mallinckrodt, Inc. Pharmaceuticals Group Follow-Up letter, 4/9/2009 (PDF - 29KB)
Paddock Laboratories, Inc.
Physicians Total Care, Inc.
Roxane Laboratories, Inc.
Xanodyne Pharmaceuticals, Inc.
Xanodyne Pharmaceuticals, Inc. Follow-Up letter, 4/9/2009 (PDF - 30KB)
Based on what?
Home - CHURCH OF METALOLOGY
churchofmetalology.webs.com/
a religion based on everything that has to do with metal.
Metalogy - the art of metal casting
Yes. Just a "gut" thing.
Nothing moves quickly in pharma space. Best to err on the slow side.
Already many of the time/date estimates in my spreadsheet are proving to be optimistic.
Good stuff will happen. Just will take more time.
I am NOT talking about developing ELI-216. I am talking about generics based on the technology of ELI-216 and ELI-154.
It will be 18 months minimum before they get funding for this, they do the BIO Equivalance studies and get FDA approval and get them on the market.
So to Dr.L, I am NOT talking about getting ELI-216 to market. I address that elsewhere in my post and put that at 2.5 years.
To Cargo, I am NOT talking about 18 months to get funding but rather 18 months to monetization of the ELI-216 / ELI-154 based generics.