Sunday, December 9, 2012
Pressure Mounts as $eltp Share Price Dips
Many shareholders have long believed Elite Pharmaceuticals (eltp) would have reached new heights with a product pipeline that appears impressive. Due to some FDA dramatics that resulted in the Company's top selling drug being taken off the shelves, shareholders knew they were in for a struggle, though their 216 patent was thought to possibly provide at very least an off-setting effect. This was not the case, and as 2012 goes, they are sitting between .07-.08, a significant dip off from where they were perched for what seemed to be ages.
As $eltp brings more drugs online there has been reason for keeping hope alive, with the ace in the sleeve being a possible large payout if they are to sell off their stake in Novel, which estimates are yet to be substantiated.
Certainly things would shine bright were the FDA to reinstate Eltp's Lodrane, the drug that was pulled.
Until these things happen and the Company is cash friendly, there will be continued bumps and bruises as the longs await driving buy-interests from the walk-ons.
Wednesday, November 14, 2012
$ELTP To Teleconference 3rd Q 2012 Results
Elite Pharmaceuticals, Inc. Reports Financial Results for the Second Quarter of Fiscal 2013
Northvale, NJ -
November 14, 2012: Elite Pharmaceuticals, Inc. (OTC:BB: ELTP), a
specialty pharmaceutical company dedicated to developing and
commercializing oral controlled release product formulations and the
manufacturing of generic pharmaceuticals, announced results for the
fiscal second quarter ended September 30, 2012.
Consolidated
revenues were $0.6 million for the quarter, an increase of 131% when
compared to the comparable quarter of the prior year. This increase is
the result of the continuing growth of the new revenue streams that have
been created within the last eighteen months.
In addition, at the
end of the quarter, Elite has received FDA approval for two new
products, Phentermine 15mg capsules and Phentermine 30mg capsules
although the launch of these products is dependent on resolution of the
API issues discussed in our press release of October 12, 2012. Elite
also currently has two products that are pending approval by the FDA for
manufacturing transfer and a third undisclosed generic product under
FDA review.
Consolidate loss
from operations was $(0.5 million) for this quarter, compared with a
loss from operations $(0.6 million) in the comparable quarter of the
prior year. GAAP net income for the quarter, including non-cash
expenses relating to the accounting treatment of preferred share and
warrant derivatives was $1.0 million, compared to a GAAP net income of
$13.9 million for the comparable quarter of the prior year, with the
difference mostly being due to changes in the value of preferred shares
and warrant derivatives. Basic earnings per share was $0.00, on a
weighted average of 348.3 million common shares outstanding, compared to
a basic earnings per common share of $0.06 and a weighted average
common shares outstanding of 248.2 million in the comparable quarter of
the prior year. Fully diluted earnings per share was $0.00, on a
weighted average diluted shares of 505.8 million, compared to fully
diluted earnings per share of $0.03 and a weighted average diluted
shares of 454.2 million in the comparable quarter of the prior year.
The increase in common shares outstanding is primarily due to conversion
of preferred shares into common shares during the last 12 months.
Jerry Treppel,
Chairman and CEO of Elite commented, "Our plan to increase revenues from
product sales, which are inherently more stable and predictable than a
milestone based revenue stream continues apace. We are in active
discussions with our phentermine API supplier and are hopeful that a
resolution can be reached, although we cannot predict if or when this
might occur. We have manufactured larger batches of product in our new
facility and begun limited packaging operations as well. We continue to
move forward with the development of our abuse-resistant opioid
products even as others in the field continue to have problems."
The Company will
host a conference call to discuss the results of operations and provide
an update on recent business developments on Thursday, November 15, 2012
at 10:00 AM EST. Company executives will also conduct a question and
answer session following their remarks.
To access the conference call:
Domestic callers: (800) 346-7359
International callers: (973) 528-0008
Conference Entry Code: 98840
International callers: (973) 528-0008
Conference Entry Code: 98840
A digital telephone
replay will be available approximately one hour after the conclusion of
the call for two weeks until November 29, 2012 by dialing:
Domestic callers: (800) 332-6854
International callers: (973) 528-0005
Conference entry code: 98840
International callers: (973) 528-0005
Conference entry code: 98840
Monday, June 25, 2012
Real Wall Street, Please Meet Elite
While Jerry Treppel does not usually appear concerned with the day-to-day PPS of ELTP, its investors are suggesting that most promotional pieces like the news release that was put out by Wall Street PR (not Wall Street Journal, but it helps...) is the best way to attract new investors. A higher PPS might even legitimize ELTP in the eyes of institutional investors in the wake of the latest company headlines:
The fluff piece further addressed the latest official loan PR by stating:
Meanwhile, the IHUBBERS are scratching at each other's eyes with both sides (basher and non-basher) making their claims. On IHUB, where boundless "pumping" is the signature name to the game, a few bashers refuse to back down.
Lasers, (on fire of late) says:
This was rebutted by Dr Low:
As the pro-ELTPs hissed, Lasers was busy brainstorming, and fired off another interesting speculative notion:
Ongoing concern/speculation over who will finance ELTP and their products is surging. There has been significant interest during the last two years from various companies like Actavis, Socius, HlTK, EPIC, TPN and TAGI (as noted by poster Tangerine). July 1st is around the corner, stay tuned for more!
Last month, Elite Pharmaceuticals was awarded U.S Patent No. 8,182,836 clearing the way for them to begin producing a time-release opiate that prevents users from abusing their product. However, it was today’s announcement of a $500,000 bridge loan that saw the stock gain nearly 15% on a day that saw the biggest across the board stock price drop in three weeks.Investors like articles like this because the company's own PR about receiving the 216 patent was far from a sales pitch. However, the information reeks of legitimacy as IHUB board wars continue to be waged.
The fluff piece further addressed the latest official loan PR by stating:
Jerry Treppel, Elite’s CEO, has agreed to provide a line of credit not to exceed $500,000 to the company he runs. The loan is being made in order for Elite to accelerate its commercialization of its existing products and the development of new products that await patent approval. The loan has been granted at a 10% annual interest rate with interest payments to be paid quarterly beginning in three months time.
The company has already begun purchasing equipment and hiring staff in anticipation of the finalization of the loan terms.
Meanwhile, the IHUBBERS are scratching at each other's eyes with both sides (basher and non-basher) making their claims. On IHUB, where boundless "pumping" is the signature name to the game, a few bashers refuse to back down.
Lasers, (on fire of late) says:
NDA505(b)(2)is approval request of a new drug dependent on a Commercial drug approved by the FDA.
You have been given links to NDA505(b)(2)in prior posts.
Embeda ALO-01 went this route by claiming Purdue approval OxyContin is similar. Pfizer/King ALO-01 was granted a NDA505(b)(2)approval in 2009.
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022321s000ltr.pdf
Pfizer is applying the NDA505(b)(2)route to ALO-02. Notice the comparison by including Purdue OxyContin in the public wording.
http://clinicaltrials.gov/ct2/show/NCT01557257
Drug: OxyContin
The problem is that in 2010 Purdue's OxyContin OC (agonist/antagonist)was replaced as OxyContin OP (hard shell agonist only). Purdue had continuing manufacturing problems with their 1-bead OxyContin OC and after several recalls gave up on it.
http://www.purduepharma.com/news-media/2010/04/statement-of-purdue-pharma-l-p-regarding-fdas-approval-of-reformulated-oxycontin-oxycodone-hcl-controlled-release-tablets/
Both 1-bead manufacturing techs Pfizer's Embeda ALO-01 and Purdue's OxyContin OC have manufacturing problems. OxyContin OC has been taken off the market in 2010 and Embeda ALO-01 has been recalled/stopped since 2010.
Until Pfizer solves the manufacturing problems for ALO-01, it cannot be expected that the FDA would approve 1-bead ALO-02!
This was rebutted by Dr Low:
No, a 505b2 is available only if the active ingredient is the same. The Embeda approval did not rely on Purdue's oxycontin in any way. It is totally illogical to try to link the AL)-02 approval to any manufacturing issues that Purdue may or may not be having
As the pro-ELTPs hissed, Lasers was busy brainstorming, and fired off another interesting speculative notion:
How about this as a speculation?
If the partner for ELI-216 Phase III trial is Watson/Actavis. Watson foots the cost for the ELI-216 Phase III and in return Watson and Elite structure a contract for Elite to apply it to Watson Morphine Sulphate opioid product that is in competition with Pfizer/King Embeda.
Elite's new 15,000 sq ft manufacturing space is idle.
Elite keeps 100% of the profits for ELI-216 oxycodone/naltrexone and in turn JVs with Watson to manufacture Watson's Morphine opioid at Elite's NJ 30,000 sq ft facilities.
Expected cost for Elite's FDA 300 person ELI-216 Phase III trial is $7 mil. Watson funds it and Watson gets $7 mil back many times over with the profits from the successful marketing of its new Morphine agonist/antagonist ELI-216 2-bead product manufactured by Elite for Watson.
Ongoing concern/speculation over who will finance ELTP and their products is surging. There has been significant interest during the last two years from various companies like Actavis, Socius, HlTK, EPIC, TPN and TAGI (as noted by poster Tangerine). July 1st is around the corner, stay tuned for more!
Sunday, June 3, 2012
OTC Equity Profiles ELTP
Here is that OTC article that is currently making it's way through investment boards...
Elite Pharmaceuticals, Inc. (OTCBB: ELTP) Continuing Development of Oral Controlled Release Product Formulations It was a wild few days for Elite Pharmaceuticals, Inc. (OTCBB: ELTP) last week as shares of the specialty pharmaceutical company dedicated to developing and commercializing oral controlled release product formulations hit a six-month high of 0.1740 on Tuesday, fell to a low of 0.111 on Wednesday, climbed to 0.1498 on Thursday before closing out the week at 0.1200. With the volatility came high trading volume as ELTP consistently topped their average while investors looked to find the right time to jump in. ELTP has started the trading week off in the same spirit as last with their share price bouncing from a low of 0.1171 up to 0.1400. Those shares are currently trading around the 0.1310 level, just above their 50-day moving average of 0.1266 and their 200-day moving average of 0.1008. The only news coming from ELTP as of late was their announcement back on May 22, 2012 that they had been issued a U.S. Patent entitled “Abuse-Resistant Oral Dosage Forms and Method of Use Thereof” by the United States Patent and Trademark Office (USPTO), a patent that ELTP says will further protect their proprietary formulation for abuse resistant products utilizing the pharmacological approach. Company CEO, Jerry Treppel, called the patent issuance, “an important milestone for the company. It validates our pharmacological approach to the development of abuse-resistant drug products and provides additional value for these products.” Given the steady rise in prescription drug abuse the controlled release products developed by ELTP could have a significant role in how drugs are administered in the future. At the moment ELTP has four ANDA products partnered with a sales and marketing partner; two of these ANDA’s have launched, one ANDA is in the process of a manufacturing site transfer and a fourth ANDA is currently under review by the FDA. Their lead pipeline products include a once-daily abuse resistant opioid, and a once-daily opioid. They are sustained release oral formulations of opioids for the treatment of chronic pain, which address two of the limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential abuse. These products are in a Phase III pending stage. Back in March ELTP announced that they had entered into an agreement to develop, for a private Hong-Kong-based company, a branded prescription pharmaceutical product. Under the terms of that deal the private company would provide the formulation for the product and ELTP would undertake a development program for the product. This deal certainly has some advantageous for ELTP as the private company will be responsible for the filing of the New Drug
Application for the finished product and the NDA will be filed under that company’s name. Once the NDA has been approved ELTP will retain certain rights to manufacture the product while the private company maintains the responsibility for the marketing and sales of the final product and ELTP will be paid milestone payments for the development work. The big question investors have for ELTP is where are they headed, the company seems to have their hands in a lot of different areas right now but according to their most recent quarterly report, for the period ended December 31, 2011, they identified their strategy as “focusing its efforts on the following areas: (i) development of Elite’s pain management products, including abuse resistant products, (ii) set up and launch of approved generic products; (iii) the development of the other products in our pipeline including the eight products pursuant to the Epic Strategic Alliance Agreement; (iv) commercial exploitation of our products either by license and the collection of royalties, or through the manufacture of our formulations, and (v) development of new products and the expansion of our licensing agreements with other pharmaceutical companies, including co-development projects, joint ventures and other collaborations.” It’s hard not to have some respect for ELTP given what went down with the FDA back in March 2011 when they decided to pull 500 cough/cold and allergy related products from the U.S. market, among them the daily allergy products manufactured by Elite, Lodrane 24 and Lodrane 24D. ELTP didn’t duck this obstacle or use it as an excuse to their shareholders, instead they have worked hard to move forward and if things work in their favor there could be a nice reward for shareholders who built a strong position at a low price.
Here is that product list
Methadone Contract mfg - Launched jan 2012 Phentermine
ELTP Generic - Launched April 2011 Hydromorphone
ELTP Generic - Launched March 2012 Naltrexone
FDA supplement - Change of facility Undisclosed ANDA TAGI.
Pending FDA Approval-Scheduled Drug New ANDA recent App
Pending FDA Approval Epic 1
Pending FDA Approval Epic 2
N/A Epic 3 N/A Epic 4 N/A Epic 5 N/A Epic 6 N/A Epic 7 N/A Epic 8 N/A Lodrane D
Launched August 2011 Lodrane 24
ECR working with FDA - 3rd-4th qtr 2012 Lodrane 24D
ECR working with FDA - 3rd-4th qtr 2012
HITK 100m generic
Development/ Pending FDA Appr. -1/2011 Hong Kong NDA Develop.
In development Signed March 2012 Mikah Development NDA
In development? Isradipine
Pending FDA App. - Transfer work begun Phendimetrazine
Pending FDA App. - Transfer work begun Eli 216
Scaleup of commercial batches-Patent for formulation approved Eli 154 - Need partner for half (Editor - I think this was ditched.)
Elite Pharmaceuticals, Inc. (OTCBB: ELTP) Continuing Development of Oral Controlled Release Product Formulations It was a wild few days for Elite Pharmaceuticals, Inc. (OTCBB: ELTP) last week as shares of the specialty pharmaceutical company dedicated to developing and commercializing oral controlled release product formulations hit a six-month high of 0.1740 on Tuesday, fell to a low of 0.111 on Wednesday, climbed to 0.1498 on Thursday before closing out the week at 0.1200. With the volatility came high trading volume as ELTP consistently topped their average while investors looked to find the right time to jump in. ELTP has started the trading week off in the same spirit as last with their share price bouncing from a low of 0.1171 up to 0.1400. Those shares are currently trading around the 0.1310 level, just above their 50-day moving average of 0.1266 and their 200-day moving average of 0.1008. The only news coming from ELTP as of late was their announcement back on May 22, 2012 that they had been issued a U.S. Patent entitled “Abuse-Resistant Oral Dosage Forms and Method of Use Thereof” by the United States Patent and Trademark Office (USPTO), a patent that ELTP says will further protect their proprietary formulation for abuse resistant products utilizing the pharmacological approach. Company CEO, Jerry Treppel, called the patent issuance, “an important milestone for the company. It validates our pharmacological approach to the development of abuse-resistant drug products and provides additional value for these products.” Given the steady rise in prescription drug abuse the controlled release products developed by ELTP could have a significant role in how drugs are administered in the future. At the moment ELTP has four ANDA products partnered with a sales and marketing partner; two of these ANDA’s have launched, one ANDA is in the process of a manufacturing site transfer and a fourth ANDA is currently under review by the FDA. Their lead pipeline products include a once-daily abuse resistant opioid, and a once-daily opioid. They are sustained release oral formulations of opioids for the treatment of chronic pain, which address two of the limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential abuse. These products are in a Phase III pending stage. Back in March ELTP announced that they had entered into an agreement to develop, for a private Hong-Kong-based company, a branded prescription pharmaceutical product. Under the terms of that deal the private company would provide the formulation for the product and ELTP would undertake a development program for the product. This deal certainly has some advantageous for ELTP as the private company will be responsible for the filing of the New Drug
Application for the finished product and the NDA will be filed under that company’s name. Once the NDA has been approved ELTP will retain certain rights to manufacture the product while the private company maintains the responsibility for the marketing and sales of the final product and ELTP will be paid milestone payments for the development work. The big question investors have for ELTP is where are they headed, the company seems to have their hands in a lot of different areas right now but according to their most recent quarterly report, for the period ended December 31, 2011, they identified their strategy as “focusing its efforts on the following areas: (i) development of Elite’s pain management products, including abuse resistant products, (ii) set up and launch of approved generic products; (iii) the development of the other products in our pipeline including the eight products pursuant to the Epic Strategic Alliance Agreement; (iv) commercial exploitation of our products either by license and the collection of royalties, or through the manufacture of our formulations, and (v) development of new products and the expansion of our licensing agreements with other pharmaceutical companies, including co-development projects, joint ventures and other collaborations.” It’s hard not to have some respect for ELTP given what went down with the FDA back in March 2011 when they decided to pull 500 cough/cold and allergy related products from the U.S. market, among them the daily allergy products manufactured by Elite, Lodrane 24 and Lodrane 24D. ELTP didn’t duck this obstacle or use it as an excuse to their shareholders, instead they have worked hard to move forward and if things work in their favor there could be a nice reward for shareholders who built a strong position at a low price.
Here is that product list
Methadone Contract mfg - Launched jan 2012 Phentermine
ELTP Generic - Launched April 2011 Hydromorphone
ELTP Generic - Launched March 2012 Naltrexone
FDA supplement - Change of facility Undisclosed ANDA TAGI.
Pending FDA Approval-Scheduled Drug New ANDA recent App
Pending FDA Approval Epic 1
Pending FDA Approval Epic 2
N/A Epic 3 N/A Epic 4 N/A Epic 5 N/A Epic 6 N/A Epic 7 N/A Epic 8 N/A Lodrane D
Launched August 2011 Lodrane 24
ECR working with FDA - 3rd-4th qtr 2012 Lodrane 24D
ECR working with FDA - 3rd-4th qtr 2012
HITK 100m generic
Development/ Pending FDA Appr. -1/2011 Hong Kong NDA Develop.
In development Signed March 2012 Mikah Development NDA
In development? Isradipine
Pending FDA App. - Transfer work begun Phendimetrazine
Pending FDA App. - Transfer work begun Eli 216
Scaleup of commercial batches-Patent for formulation approved Eli 154 - Need partner for half (Editor - I think this was ditched.)
Thursday, May 31, 2012
ELTP - P&D or Stock Hero ?
Tough to call these days, the market is at an all-time low for marginal companies. These days a lot of really great news won't budge the PPS upward. In fact, if there's anticipation for the news and a run-up brings the stock up 20-40%, chances are there will be a sell-off. This happened to ELTP after the announcement that they were awarded a patent for 216, a huge accomplishment that gave the shareholders going long more reasons to question the meaning of life. The stock moved up to a 26-week high of .17(and change) prior to the announcement on May 22nd, and since then the stock has slipped down in to the .11 range. 11 cents? So what is really going on here? So much. The nature of the beast is there's still too many people betting for ELITE to lose for a little patent tech to be that driving force. I know, right? Anyway, lots of great links and DD to find out there. While the margin of error is slim for ELTP, there's so much to look forward to. The company isn't pumping us with useless PRs or weak CCs.
Following a few posts over Ihub (shoot me now), here's today's vibe... which you will notice hasn't changed a whole lot in recent weeks/months/years.
by poster TOOFUN:
by poster Tangerine:
Following a few posts over Ihub (shoot me now), here's today's vibe... which you will notice hasn't changed a whole lot in recent weeks/months/years.
by poster TOOFUN:
Unfortunately, I have to keep this brief. Unlike the vast majority of penny stocks, this one has a foundation in reality. Meaning products that are presently on sale or soon to be on sale and a reasonable promise of future drugs (including the return of Lodrane) which are not dependent on some binary phase three efficacy event, which have a tendency of "blowing up" in a bad way. No this investment/company is grounded in the mundane world of generic retreads and has added value in the prospects of its own novel drugs in the not too distant future. TEVA didn't get to be TEVA through great invention just hard work. Grinding out each quarter with well applied effort through sound management is what I believe the company is doing and that in the end will make it profitable and eventually hit the home runs. This is what makes ELTP a novel penny stock and a good investment.
JMHO.
OK, so that wasn't brief.
by poster dLOW:
Hyping the 2 bead patent like it is some kind of miracle invention. Claiming that the SPA assures fast track status and a 505b2 filing (the SPA does not), claiming that the Pfizer oxy/naltrrxone product has stability issues (why would they bo doing clinical trials if that were true), claiming that the company has mega millions in revenue- it doesn't, etc etc etc. It will be fun to watch Lite during this process.
by poster Tangerine:
Summary - Facts
Added in the mfg and the hiring and updated the patent date
The huge news is that it looks like Elite is getting the abuse resistant patent. This was the company's primary focus when they traded on the Amex. The tech is for all Opiates. It is a $20 billion dollar market. Well, it looks like they got it!
"The issuance of this patent is an important milestone for the company. It validates our pharmacological approach to the development of abuse-resistant drug products and provides additional value for these products," said Jerry Treppel, Elite's Chairman and CEO. "
Elite has been moving forward, rapidly growing its pipeline, partners and revenue sources. Most of the revenue producing products are just recently approved/launched. Many more are close.
Fact, one year ago they had one product, now they have 4 and they are just in their infancy for the most part. One year ago they had a couple partners, now they have upwards of 7 and some like Actavis and HITK quite large and global
Cash flow positive - ~500k - should be close this past Q- from the NJEDT from their program to assist companies. Elite was ~500k in the red the previous on just R&D, Phentermine and newly launched Lodrane D. The CFO noted that R&D revenues were continuing as they were. Simply add in the 500k, the launch of generic methadone and hydromorphone(dilaudid)
FACT based on simple math and listening to the CC
Operating profit - Will depend on the items above, as well as the items noted below. Should be close based on current projections in Q1, and met in Q2.
FACT based on simple math and listening to the CC
Approval/Launch of generic Naltrexone - Inspections were completed back in August. Supplement application for change of facility ~November/December - Due any time
FACT based on numerous filings, and listening the conference call
Approval and Launch of 4th ANDA - Also inspected for in August. Due any time
FACT just based on listening to the CC and numerous filings
Beginning of R&D for Hong Kong deal. Elite is developing an NDA for a Hong Kong Pharma company - Deal signed a couple weeks ago. Product already exists overseas.
FACT based new deal signed unless you believe the company is not telling the truth and really didn't sign a deal
Launch of 1st of 8 Epic drugs - Elite gets a profit split and I think milestones. Submitted to FDA quite a while ago
Fact From CCs and numerous filings
Hi-tech (HITK)- Partnership on generic of 100m branded product - development and manufacturing deal. Been working on this for over a year. Milestone, R&D and profit split I believe
Fact From CCs and numerous filings
Actavis/Mikah products for contract mfg - (Isradipine, Phendimetrazine) and working R&D MIK001. Elite is making Mikah's leading products per their website. Tech transfer began quite a while ago. Again, waiting on the FDA. Note that Mikah has increased the number of products on their website, with many approved ANDAs. We will see if Elite will be making these.
Fact From CCs and numerous filings
Lodrane 24, 24D expected return- 3rd, 4th quarter - ! 1 year ago, Elite hit operating profit on these two products alone. Then the FDA pulled 500 cold meds. Being worked as an NDA
Fact based on discussion with ECR
Socius funding - Elite has access to 5m in funding if they need it for PH3 of Eli 216
Fact From CCs and numerous filings
PH3 Eli - 216 - Market data has this once a day abuse resistant Oxycontin, PH3 pending product at 800m. Protected by the patent being approved.
Fact and discussed a million times with proven independent market data
Eli 154 - Once a day oxycontin - Elite has a partner willing to fund half, need second half
Fact based on CCs and filings
Another pending ANDA - submitted more recently
Fact based on CCs and filings
Fact - Elite is hiring
Fact - Elite is almost completed with their second manufacturing facility which doubles there capacity
Tuesday, May 22, 2012
2nd Quarter Expectations
Some posters are out there claiming to be do good things for investors and potential investors. Nobody can predict the future with certainty, so there is always a lowering of expectations, hard work and objectivity that goes in to being a trusted source for information. Who do we trust versus who do we toss aside (or add to the ignore list)? The key is to not allow any one to dictate your decisions with money. You have that final say, and that should be empowering enough.
This is yet another post by Pagiantmetknicksfan. This poster keeps close tabs on the ELTP pipeline, and for a post that originated on April Fool's Day, it holds up well against anything any ELTP basher has advocated. Here's pagiant's post:
2nd Quarter Expectations
This is yet another post by Pagiantmetknicksfan. This poster keeps close tabs on the ELTP pipeline, and for a post that originated on April Fool's Day, it holds up well against anything any ELTP basher has advocated. Here's pagiant's post:
2nd Quarter Expectations
Naltrexone approval and launch – We learned that in November, Elite
received the same supplemental approval requirement for change of
facility as Hydromorphone. Thus the delay. Inspections occurred in
August – Should be approved 2nd quarter
Predicted 4th TAGI ANDA approval and Launch – Inspections also in August. 6 months is typical for approval. We are 8-9 months. Expecting to see it 2nd quarter 2012. As noted by the CEO, ANDAs are taking longer and longer.
I predicted patent news saying that is was “very very close”– Both of the Eli patents were rejected. However, regarding Eli 216, Elite has submitted amended claims on 3/30 based on discussion with the patent examiner. The patent examiner stated that the results are unexpected (ie not obvious) so Elite’s argument is very strong. The rejection was that the argument cited ranges which were not represented in the claim. The claims have been resubmitted with these items removed. Again, this was based on Elite's discussion with the patent examiner. Elite has requested a quick approval as the USPTO basically agrees that the results were “unexpected”.
Eli 154 patent is not going to be pursued further. Elite stated they feel it is not worth the expense and will rely on their IP. They have a partner willing to fund half but still need the other half. Note that their tech in ELI 216 is also for the extended release.
Epics 1st of 8 Elite products - Transfer began some time ago but based on the current FDA timelines, it could be a quarter or two before approval. Up to the FDA.
HITK - 100m generic - I thought we might see news on this and I think we have. Look at the R&D revenues we saw in the previous Q and expected this Q.
Actavis drugs – The tech is undergoing transfer to Elite for contract mfg. This began quite a while ago. Since it is contract mfg and an approved product, I am hoping to see these products in Q2. Isradipine is the one to watch with a huge worldwide market and few competitors.
Lodrane extended products – The e-mail I received from ECR stated that they are hopeful to have the products back on the shelf towards the end of the year. The FDA requested add'l data. This puts NDA approval sometime 3rd Q to have the products out 4th Q, but you never know.
New Items
$5m funding through Socius. Will we see a tranche delivered for this money? I think this is for Eli 216 trials and that will likely be the trigger.
Deal with a Hong Kong Pharma for end to end development of an NDA – We don’t know what the milestones will be but I suspect there is some right at the front to pay for ramp up costs.
Cash Flow Positive – Pretty obvious. Elite ran ~500k in the red last quarter with just Phantermine, new Lodrane just launched and R&D. The CFO noted that that R&D revenue was on the same impressive pace as the previous Q. The NJEDT program gave Elite ~500k. This makes them cash flow positive by itself. Add in the revenues for contract mfg of Methadone which started this Q and launch of Hydromorphone.
Profitability – This is likely to be very close because of the addition of Hydromorphone and Methadone and continued growth of the existing TAGI products. If we can Launch Naltrexone, and/or a couple more products Elite should be able to hit profit. The big key for me here is the HK NDA development deal. Instant cash
New Epic deal – Could be big, could be just BAU type stuff
Update on Eli 216 studies, PH3 plans - ???
Add'l Mikah – More products added to their website and the statement that Elite will be making their leading products. I believe most of these were discont'd from Actavis Totowa NJ.
Elite's second facility coming online...
Predicted 4th TAGI ANDA approval and Launch – Inspections also in August. 6 months is typical for approval. We are 8-9 months. Expecting to see it 2nd quarter 2012. As noted by the CEO, ANDAs are taking longer and longer.
I predicted patent news saying that is was “very very close”– Both of the Eli patents were rejected. However, regarding Eli 216, Elite has submitted amended claims on 3/30 based on discussion with the patent examiner. The patent examiner stated that the results are unexpected (ie not obvious) so Elite’s argument is very strong. The rejection was that the argument cited ranges which were not represented in the claim. The claims have been resubmitted with these items removed. Again, this was based on Elite's discussion with the patent examiner. Elite has requested a quick approval as the USPTO basically agrees that the results were “unexpected”.
Eli 154 patent is not going to be pursued further. Elite stated they feel it is not worth the expense and will rely on their IP. They have a partner willing to fund half but still need the other half. Note that their tech in ELI 216 is also for the extended release.
Epics 1st of 8 Elite products - Transfer began some time ago but based on the current FDA timelines, it could be a quarter or two before approval. Up to the FDA.
HITK - 100m generic - I thought we might see news on this and I think we have. Look at the R&D revenues we saw in the previous Q and expected this Q.
Actavis drugs – The tech is undergoing transfer to Elite for contract mfg. This began quite a while ago. Since it is contract mfg and an approved product, I am hoping to see these products in Q2. Isradipine is the one to watch with a huge worldwide market and few competitors.
Lodrane extended products – The e-mail I received from ECR stated that they are hopeful to have the products back on the shelf towards the end of the year. The FDA requested add'l data. This puts NDA approval sometime 3rd Q to have the products out 4th Q, but you never know.
New Items
$5m funding through Socius. Will we see a tranche delivered for this money? I think this is for Eli 216 trials and that will likely be the trigger.
Deal with a Hong Kong Pharma for end to end development of an NDA – We don’t know what the milestones will be but I suspect there is some right at the front to pay for ramp up costs.
Cash Flow Positive – Pretty obvious. Elite ran ~500k in the red last quarter with just Phantermine, new Lodrane just launched and R&D. The CFO noted that that R&D revenue was on the same impressive pace as the previous Q. The NJEDT program gave Elite ~500k. This makes them cash flow positive by itself. Add in the revenues for contract mfg of Methadone which started this Q and launch of Hydromorphone.
Profitability – This is likely to be very close because of the addition of Hydromorphone and Methadone and continued growth of the existing TAGI products. If we can Launch Naltrexone, and/or a couple more products Elite should be able to hit profit. The big key for me here is the HK NDA development deal. Instant cash
New Epic deal – Could be big, could be just BAU type stuff
Update on Eli 216 studies, PH3 plans - ???
Add'l Mikah – More products added to their website and the statement that Elite will be making their leading products. I believe most of these were discont'd from Actavis Totowa NJ.
Elite's second facility coming online...
Elite Pharmaceuticals Announces Issuance of U.S. Patent for Abuse Resistant Oral Dosage Formulation
What a good long fight to win a patent of significant proportions. This is a major battle the ELTP team has won after years of grappling with TPTB.
How will this fact impact ELTP's PPS? Opinions are overwhelmingly positive in the chatboards, but who listens to those, right? There is a poster going by the name Dr. Lowenstein you may see popping up on boards discussing information on ELTP. It appears that he been given the magical gift of distraction. His famous quote tagline is "LOL," and makes us all knowledgeable that ELTP has competition. And yeah there's a ton of other stories about life on the chat boards. The speculation is interesting and makes our days, weeks, years go by. Remember these people don't do what they do for free, it costs money to hold a beast like ELTP down for so long. Facts are facts, investors. And without question the person doing the most consistent/active DD on the boards is pagiantmetsknicksfan. Here is one of pagiantmetknicksfan's popular posts:
(Editor's "Objective" Disclaimer -- Sorry Dr. Low, you don't have any worthy DD to add here. The only real testimony to your DD is your ability to find weaker products from competitors to downplay this patent.)
The big news is Elite is getting the patent for their abuse resistant opioid technology. This patent can be used to develop abuse resistant versions of pretty much every opioid based drug.
Here is the patent App#, review for yourselves - (App# 12/478,952)
The opioid market ~ 20 billion dollars a year. Elite's closest competitor is Embeda which uses a core of Naltrexone but that product was pulled from the market for mfg issues.
Patent supports Eli 216, Elite's PH3 $800m, once a day abuse resistant oxy pill. You won't find one on the market.
While this is huge, there are so many pending items. Here is the list. Also, below is the list of IDs used to manipulate and confuse on this msg board. My opinion, verify everything for yourselves.
Elite has been moving forward, rapidly growing its pipeline, partners and revenue sources. Most of the revenue producing products are just recently approved/launched. Many more are close.
Cash flow positive? - ~500k from the NJEDT from their program to assist companies. Elite was ~500k in the red the previous Q on just R&D, Phntermine and newly launched Lodrane D. The CFO noted that R&D revenues were continuing as they were. Simply add in the 500k, the launch of generic methadone and hydromorphone.
Operating profit - Based on the items above, as well as the items noted below. Should be close based on current projections in Q1,and met in Q2.
Approval/Launch of generic Naltrexone - Inspections in August. Supp. application for change of facility ~November/December
Approval and Launch -4th ANDA - Also inspected in August. Due any time
New R&D for Hong Kong Pharma. Elite is contract developing an NDA - Product already exists overseas.
Upcoming launch of 1st of 8 Epic drugs - Profit split and milestones. Submitted to FDA quite a while ago
New Hi-tech (HITK)- Partnership on generic of $100m branded product - development and manufacturing deal. Been working on this for over a year. Milestone, R&D and profit split
Actavis/Mikah products for contract mfg - (Isradipine, Phendimetrazine) and working R&D MIK001. Elite is making Mikah's leading products per their website. Tech transfer began quite a while ago. Again, waiting on the FDA. Note that Mikah has increased the number of products on their website, with many approved ANDAs. We will see if Elite will be making these too.
Lodrane 24, 24D - expected return- 3rd, 4th quarter - 1 year ago, Elite hit operating profit on these two products alone. Then the FDA pulled 500 cold meds. Being worked as an NDA with Elite providing support.
Socius funding - Elite has access to 5m in funding if they need it for PH3 of Eli 216 or other projects
And Eli 154 - Once a day oxycontin - Elite has a partner willing to fund half, need second half
Another pending ANDA - submitted more recently
NORTHVALE, N.J., May 22, 2012 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP.OB - News)
announced the issuance of U.S Patent No. 8,182,836 entitled
"Abuse-Resistant Oral Dosage Forms and Method of Use Thereof" by the United States Patent and Trademark Office
(USPTO). The issuance of this patent will further protect Elite's
proprietary formulation for abuse resistant products utilizing the
pharmacological approach. The Company has additional patents pending for its technology.
"The issuance of this patent is an important milestone for the company.
It validates our pharmacological approach to the development of
abuse-resistant drug products and provides additional value for these products," said Jerry Treppel, Elite's Chairman and CEO.How will this fact impact ELTP's PPS? Opinions are overwhelmingly positive in the chatboards, but who listens to those, right? There is a poster going by the name Dr. Lowenstein you may see popping up on boards discussing information on ELTP. It appears that he been given the magical gift of distraction. His famous quote tagline is "LOL," and makes us all knowledgeable that ELTP has competition. And yeah there's a ton of other stories about life on the chat boards. The speculation is interesting and makes our days, weeks, years go by. Remember these people don't do what they do for free, it costs money to hold a beast like ELTP down for so long. Facts are facts, investors. And without question the person doing the most consistent/active DD on the boards is pagiantmetsknicksfan. Here is one of pagiantmetknicksfan's popular posts:
(Editor's "Objective" Disclaimer -- Sorry Dr. Low, you don't have any worthy DD to add here. The only real testimony to your DD is your ability to find weaker products from competitors to downplay this patent.)
The big news is Elite is getting the patent for their abuse resistant opioid technology. This patent can be used to develop abuse resistant versions of pretty much every opioid based drug.
Here is the patent App#, review for yourselves - (App# 12/478,952)
The opioid market ~ 20 billion dollars a year. Elite's closest competitor is Embeda which uses a core of Naltrexone but that product was pulled from the market for mfg issues.
Patent supports Eli 216, Elite's PH3 $800m, once a day abuse resistant oxy pill. You won't find one on the market.
While this is huge, there are so many pending items. Here is the list. Also, below is the list of IDs used to manipulate and confuse on this msg board. My opinion, verify everything for yourselves.
Elite has been moving forward, rapidly growing its pipeline, partners and revenue sources. Most of the revenue producing products are just recently approved/launched. Many more are close.
Cash flow positive? - ~500k from the NJEDT from their program to assist companies. Elite was ~500k in the red the previous Q on just R&D, Phntermine and newly launched Lodrane D. The CFO noted that R&D revenues were continuing as they were. Simply add in the 500k, the launch of generic methadone and hydromorphone.
Operating profit - Based on the items above, as well as the items noted below. Should be close based on current projections in Q1,and met in Q2.
Approval/Launch of generic Naltrexone - Inspections in August. Supp. application for change of facility ~November/December
Approval and Launch -4th ANDA - Also inspected in August. Due any time
New R&D for Hong Kong Pharma. Elite is contract developing an NDA - Product already exists overseas.
Upcoming launch of 1st of 8 Epic drugs - Profit split and milestones. Submitted to FDA quite a while ago
New Hi-tech (HITK)- Partnership on generic of $100m branded product - development and manufacturing deal. Been working on this for over a year. Milestone, R&D and profit split
Actavis/Mikah products for contract mfg - (Isradipine, Phendimetrazine) and working R&D MIK001. Elite is making Mikah's leading products per their website. Tech transfer began quite a while ago. Again, waiting on the FDA. Note that Mikah has increased the number of products on their website, with many approved ANDAs. We will see if Elite will be making these too.
Lodrane 24, 24D - expected return- 3rd, 4th quarter - 1 year ago, Elite hit operating profit on these two products alone. Then the FDA pulled 500 cold meds. Being worked as an NDA with Elite providing support.
Socius funding - Elite has access to 5m in funding if they need it for PH3 of Eli 216 or other projects
And Eli 154 - Once a day oxycontin - Elite has a partner willing to fund half, need second half
Another pending ANDA - submitted more recently
Tuesday, May 8, 2012
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