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Forward looking knowing the business.
CEO,
Nasrat Hakim
Okay. Thank you, Carter. Next question is on increased and authorized, was the increase in shares issued related to CEO holding and how can you guarantee investors that further dilution will not happen?
A part of it was due to the Series J. But the other parts were for us to have the ability to have to conclude business opportunities similar to the one I just explained to with SunGen. If these shares were available and they were presented and we could actually catch them out we would have had a very good deal with a company, which had a lot of product in that pipeline including some that are first to file and [paragraph] for filings. You always need the ability to maneuver otherwise we continue producing very little and taking that very little first getting to the point of breaking even and then maybe a little bit profitable and that little im-profitability will take us forever to get one product through the market. And maybe one of these days we should have a Board with the stockholders if that's the rate that we need to go on that's the rate we have to go on. But for us, to go after new products and get the companies next level and increase revenues and all the things that people ask me to do, and do it with nothing that's asking a little too much. So, yes, there is a potential that we may be using some of these shares but anything we use is for Elite benefit and for the stockholders benefit, okay. Nothing extravagant. It's all R&D related that we hope the return on the investment will be several folds once the R&D succeeds.
https://seekingalpha.com/article/4356443-elite-pharmaceuticals-inc-eltp-ceo-nasrat-hakim-on-q4-2020-results-earnings-call-transcript?page=6
12,4,22
Good Luck Everyone!
Rumor on the street. Merger before buyout.
Nasrat will bundle Mikah with Elite before the Hammer falls.
JMO
ELTP$$$$
Nasrat Hakim
Thank you, Carter. What a difference a year makes. An increase in revenue from $7.6 million to $18 million is a solid step in the right direction, becoming profitable enough to support an R&D pipeline would get us to the right destination. That is where we want to be. An essential part of growth is to also hold on to what you have. We are working with our partner Lannett to protect our current shares of the market and ensure that we grow it. Lannett is in charge of sales and marketing and they have done a very good job with the market shares for the IR in spite of the fact that it's a saturated market with 11 players. We trust they'll do the same thing with amphetamine ER. From our side, Elite is protecting and improving the business by ensuring that our GMP facility has the right capacity, equipment, material and personnel to support Lannett and our other sales and marketing partners.
We secured enough API quota from the DEA to support Lannett's sales projections through the end of this year. That is fantastic news. We struggled with that in the first quarter and a little bit in the second and finally the DEA came around and gave us enough quota to support the sales and marketing projections through the end of the year. In March, Elite was inspected by the FDA again for Pharmacovigilance and REMS. After eight day inspection the FDA issued a minor observation on a Form 483. The observation was for our website not having a link to REMS for [Indiscernible]. We explained to the FDA that the product is not and has never been marketed or commercialized. Further the link on the website to the REMS was corrected three days before. They issued the observation that did not help. We still got a minor observation but the FDA was kind enough to annotate that it was corrected before they left.
Regardless, this is a great outcome and outstanding news. That makes five inspections, four of which we got zero observations and one that we got this Mickey Mouse observation for. Elite has also successfully pivoted away from opioids during the opioid crisis and the negative environment and lawsuits that came with it and we are extremely lucky that we have never been a part of that. Elite is executing on its growth plan, getting product approvals and launching new products. And our sales and marketing partners Glenmark, TAGI and Lannett are all performing well.
https://seekingalpha.com/article/4356443-elite-pharmaceuticals-inc-eltp-ceo-nasrat-hakim-on-q4-2020-results-earnings-call-transcript?page=3
Elite Pharmaceuticals, Inc. (ELTP) CEO Nasrat Hakim on Q4 2020 Results - Earnings Call Transcript
The increase in revenues can be attributed to the three products that we launched during fiscal 2020. Those are generic Adderall, immediate-release Adderall, generic Dantrolene and to a lesser extent for fiscal 2020 at least generic extended-release Adderall. The extended-release Adderall was launched at the very end of 2020 fiscal year.
So remember, our revenues consist of two distinct streams. There's manufacturing revenues and there's profit splits. The manufacturing revenues, those are earned when we make and we ship the product. So those increased from $5.4 million in 2019 to $14.5 million in 2020. It's a $9.1 million increase or a 166%. The main drivers here are the three generic products launched this year, ones I just mentioned immediate release Adderall; extended release Adderall and Dantrolene and our existing products prior to those from the prior years. They've also had very strong years especially Isradipine and Naltrexone. You also have to give it a lot of credit to our manufacturing lab and quality personnel, as well as our supply chain partners. All have done a phenomenal job ensuring that we continue to run on all cylinders producing record volumes, shipping record volumes and all of this during the current Covid pandemic.
So that's quite an achievement, really remarkable what everybody has done. The other parts of our revenues are profits splits and those we earn as our marketing partners sell into the market. These depend on the timing of their in market sales so there's a natural lag of a few quarters up to even four or could even be six quarters from when we manufacture to when those in market sales are achieved. And when we earn those profit split revenues. So profit splits, they're up from $2.2 million in 2019 to $3.5 million this year. So that's a $1.3 million increase or 59%. So you notice there's a lower rate of increase in profit splits as compared to manufacturing revenues. And this is due to the timing lag I just mentioned between the two types of revenues especially since the extended-release Adderall was launched during the last month of the year. So we ship launched quantities during March 2020, but other than a $375,000 milestone earned when we launched the product, will be earning the profit split revenues as our marketing partner which is Lannett as they sell it into the market. So it takes a few quarters after the product launch for the profit splits to start coming online.
So immediate release Adderall and Dantrolene were launched earlier in the fiscal year, fiscal 2020. So they've already started to positively impact on profit split revenues. And amphetamine, the Adderall extended release has not yet impacted profit split revenues because they were launched right at the end of the year. But we do expect additional contribution from the extended release Adderall as those profit splits start to come online over the next few quarters. So you put the increases in both manufacturing revenues and profit split together, you get total revenues going up from $7.6 million to $18 million in a single year. So before moving on, I think it's important to keep in mind that extended release Adderall has just been launched and the immediate release version of Adderall as well as Dantrolene they're both relatively new in the market.
Our marketing partner has done a great job with all of these products, but there's still room for growth in the future. So moving down the P&L, we come to research and development expenses, which went down from $7.6 million last year 2019 to $5.5 million this year fiscal 2020. That's a $2.1 million decrease or 28%. As I've always said there are two things to always keep in mind when it comes to R&D expenses. First is that R&D is the lifeblood of any pharmaceutical company. A large part of the $7.6 million that we spend in 2019, they went to the products that were launched in early 2020 and part of the $5.5 million spent this year in 2020 also went to the product that we launched at the very end of fiscal 2020.
https://seekingalpha.com/article/4356443-elite-pharmaceuticals-inc-eltp-ceo-nasrat-hakim-on-q4-2020-results-earnings-call-transcript?page=2
12,19,2
Good Luck Everyone!
Elite, Lannett launch generic Adderall XR
This article was found in (The Drug Store news)
Elite, a specialty pharmaceutical company, is introducing its generic Adderall XR via its marketing partner Lannett.
Adderall XR is a once-daily central nervous system stimulant and is indicated for the treatment of attention deficit hyperactivity hisorder.
The product, which is a generic of Shire's Adderall XR, is an extended-release mixed salt of a single-entity amphetamine product (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate). The capsules are available in dosage strengths of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg.
"Generic Adderall XR extends our offering of treatments for ADHD," said Lannett CEO Tim Crew. "As we have previously noted, while the market for Adderall XR is sizable, there currently are several generic suppliers for this product. Our entire team continues to work diligently to bring more affordable medicines to patients."
Adderall XR, including generic versions, have a market value of approximately $1.3 billion for the 12 months ended January 2020, according to IQVIA.
This generic Adderall XR product is jointly owned by Elite and SunGen Pharma and is the second product launched from their collaboration. Elite will manufacture and package the generic product on a cost-plus basis. Lannett will be the exclusive U.S. distributor for the product and will provide sales, marketing, and distribution.
https://drugstorenews.com/elite-lannett-launch-generic-adderall-xr
Elite Pharmaceuticals Announces Commercial Launch of Generic Adderall XR(R) with Marketing Partner Lannett Company
NORTHVALE, NJ / ACCESSWIRE / March 31, 2020 / Elite Pharmaceuticals, Inc.
("Elite" or the "Company") (OTCQB:ELTP) a specialty pharmaceutical company
developing niche generic products, announced today that marketing partner
Lannett Company, Inc. ("Lannett"), has commenced product launch of Elite's
generic version of Adderall XR®, an extended-release mixed salt of a single
entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine
Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate) with strengths of 5
mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg capsules. Adderall XR®, including
generic versions, have an estimated IQVIA™ market value of approximately $1.3
billion for the twelve months ending January 2020. Adderall XR® is a
once-daily central nervous system stimulant and is indicated for the treatment
of Attention Deficit Hyperactivity Disorder (ADHD).
This generic Adderall XR® product is jointly owned by Elite and SunGen Pharma
LLC ("SunGen") and is the second product launched from their collaboration.
Elite will manufacture and package the generic product on a cost-plus basis.
Lannett Company, Inc. will be the exclusive U.S. distributor for the product
and will provide sales, marketing, and distribution.
https://www.bloomberg.com/press-releases/2020-03-31/elite-pharmaceuticals-announces-commercial-launch-of-generic-adderall-xr-r-with-marketing-partner-lannett-company
Congrats Eli. Strong Run.
RizZo.
Lannett Company (LCI) Stock Climbs On Distribution Agreement
Lannett Company, Inc. (NYSE: LCI) is making a run for the top in the market this morning, even while the overall market is trading in the red. The gains come after the company announced that it has entered into an exclusive distribution agreement. Here’s what’s going on:
LCI Stock Pops On Exclusive Distribution Agreement
In the press release issued this morning, Lannett Company said that it has entered into an interim exclusive supply and distribution agreement with Cediprof. The agreement surrounds Cediprof’s FDA approved Levotheyroxine Sodium Tablets USP.
In the release, LCI said that the interim supply agreement with terminate on July 31, 2022. Following the termination of the interim agreement, the 10-year exclusive supply and distribution agreement will begin.
In the 12 months ending May 2020, the sales of the drug led to approximately $2.3 billion in revenue. This suggests that this manufacturing agreement has the potential to be an incredibly profitable one.
$$$$$$$$$$$
So remember, our revenues consist of two distinct streams. There's manufacturing revenues and there's profit splits. The manufacturing revenues, those are earned when we make and we ship the product. So those increased from $5.4 million in 2019 to $14.5 million in 2020. It's a $9.1 million increase or a 166%. The main drivers here are the three generic products launched this year, ones I just mentioned immediate release Adderall; extended release Adderall and Dantrolene and our existing products prior to those from the prior years. They've also had very strong years especially Isradipine and Naltrexone. You also have to give it a lot of credit to our manufacturing lab and quality personnel, as well as our supply chain partners. All have done a phenomenal job ensuring that we continue to run on all cylinders producing record volumes, shipping record volumes and all of this during the current Covid pandemic.
So that's quite an achievement, really remarkable what everybody has done. The other parts of our revenues are profits splits and those we earn as our marketing partners sell into the market. These depend on the timing of their in market sales so there's a natural lag of a few quarters up to even four or could even be six quarters from when we manufacture to when those in market sales are achieved. And when we earn those profit split revenues. So profit splits, they're up from $2.2 million in 2019 to $3.5 million this year. So that's a $1.3 million increase or 59%. So you notice there's a lower rate of increase in profit splits as compared to manufacturing revenues. And this is due to the timing lag I just mentioned between the two types of revenues especially since the extended-release Adderall was launched during the last month of the year. So we ship launched quantities during March 2020, but other than a $375,000 milestone earned when we launched the product, will be earning the profit split revenues as our marketing partner which is Lannett as they sell it into the market. So it takes a few quarters after the product launch for the profit splits to start coming online.
So immediate release Adderall and Dantrolene were launched earlier in the fiscal year, fiscal 2020. So they've already started to positively impact on profit split revenues. And amphetamine, the Adderall extended release has not yet impacted profit split revenues because they were launched right at the end of the year. But we do expect additional contribution from the extended release Adderall as those profit splits start to come online over the next few quarters. So you put the increases in both manufacturing revenues and profit split together, you get total revenues going up from $7.6 million to $18 million in a single year. So before moving on, I think it's important to keep in mind that extended release Adderall has just been launched and the immediate release version of Adderall as well as Dantrolene they're both relatively new in the market.
https://seekingalpha.com/article/4356443-elite-pharmaceuticals-inc-eltp-ceo-nasrat-hakim-on-q4-2020-results-earnings-call-transcript
14,10,21
18,2,11
Good Luck Everyone!
Drug features
Concerta and Adderall help reduce hyperactivity and impulsive actions in people with ADHD. They’re both central nervous system stimulant drugs. This type of drug helps control the constant activity in ADHD, such as fidgeting. It also helps control impulsive actions that are common in people with certain forms of ADHD.
Concerta and Adderall are both brand-name drugs. Brand-name drugs tend to cost more than their generic versions. In general, Adderall extended-release is more expensive than Concerta, according to a review by Baylor College of MedicineTrusted Source. However, the generic form of Adderall is less expensive than the generic form of Concerta.
https://www.healthline.com/health/adhd/concerta-adderall
Pharmacist says drug supply chain interrupted by many factors amid outbreak
PALM BEACH COUNTY, Fla. (CBS12) - The Food and Drug Administration reports a shortage of more than 100 medications.
Atlantis Pharmacy fills nearly 6,000 prescriptions a month.
2 professors on staff monitor trends to avoid running out of medication, which helped ahead of the outbreak.
“We ran a list and made sure our patients have everything that they needed, to get ahead of the curve," said Pharmacist and Assistance Professor Erin Doval.
While the FDA tracks drug shortages, Atlantis Pharmacy Manager and Pharmacists Damien Simmons says that it doesn't paint a full picture.
“Watching the shortage of drugs is like watching the stock market," he told CBS12 News. "It goes up and down continuously.”
Simmons pulled up a website to show our crew how the pharmacy orders the supply. As he showed CBS12 News, while a medication may not be available through 1 manufacturer it's available through another.
He also says due to the pandemic, there have been many challenges that have interrupted the supply chain.
“The problem lies in the fact that big, big facilities if they have one person that tests positive, they have to shut down the whole wing," Simmon said. "So, everybody in that wing has to self-quarantine for 2 weeks.”
That slows down transporting stock from facilities to pharmacy shelves. In addition to facilities operating with less staff to abide by CDC guidelines.
Then stay-at-home orders have played a huge role in more demand for Adderall and Ritalin.
"All the kids are at home now, so guess what? They have to focus even more now. They have a professor on the other line that’s yelling at them on a Zoom class, with 30 other students, which is quite challenging," Simmons said.
The other big spike Simmons has seen if for Metformin, a diabetic medication.
"Most people are home and they tend to snack more and they are eating more, so the diabetics take more the medication now," he said.
Simmons says if your local pharmacy can't refill a prescription, it's important to talk to your doctors about other alternatives.
https://cbs12.com/news/coronavirus/pharmacist-says-drug-supply-chain-interrupted-by-many-factors-amid-outbreak
18,4,12
Good Luck Everyone!
OVERVIEW
Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company developing a pipeline of proprietary pharmacological abuse-deterrent opioid products and niche generic products. Elite specializes in oral sustained and controlled release drug products with high barriers to entry. Elite owns generic which have been licensed to TAGI Pharma and Glenmark Pharmaceuticals Inc., USA., and Lannett Company, Inc.
Elite currently has twelve approved generic products, four generic products filed with the FDA, one approved generic product pending manufacturing site transfer, and the NDA filing for SequestOx™.
Elite’s pipeline products include abuse-deterrent opioids which utilize the Company’s patented proprietary technology and a once-daily opioid. These products include sustained release oral formulations of opioids for the treatment of chronic pain. These formulations are intended to address two major limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential opioid abuse.
Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.
https://www.elitepharma.com/about-elite/
ABOUT OUR ABUSE-DETERRENT TECHNOLOGY
Elite’s proprietary abuse-deterrent technology, ART™, is a multi-particulate capsule which contains an opioid agonist in addition to naltrexone, an opioid antagonist used primarily in the management of alcohol dependence and opioid dependence. When this product is taken as intended, the naltrexone is designed to pass through the body unreleased while the opioid agonist releases over time providing therapeutic pain relief for which it is prescribed. If the multi-particulate beads are crushed or dissolved, the opioid antagonist, naltrexone, is designed to release. The absorption of the naltrexone is intended to block the euphoria by preferentially binding to same receptors in the brain as the opioid agonist and thereby reducing the incentive for abuse or misuse by recreational drug abusers. Elite’s pharmacological approach to abuse-deterrence can be applied to a wide range of opioids used today in pain management
https://www.elitepharma.com/technology-overview/
Elite Pharmaceuticals, Inc. (ELTP) CEO Nasrat Hakim on Q4 2020 Results - Earnings Call Transcript
The increase in revenues can be attributed to the three products that we launched during fiscal 2020. Those are generic Adderall, immediate-release Adderall, generic Dantrolene and to a lesser extent for fiscal 2020 at least generic extended-release Adderall. The extended-release Adderall was launched at the very end of 2020 fiscal year.
So remember, our revenues consist of two distinct streams. There's manufacturing revenues and there's profit splits. The manufacturing revenues, those are earned when we make and we ship the product. So those increased from $5.4 million in 2019 to $14.5 million in 2020. It's a $9.1 million increase or a 166%. The main drivers here are the three generic products launched this year, ones I just mentioned immediate release Adderall; extended release Adderall and Dantrolene and our existing products prior to those from the prior years. They've also had very strong years especially Isradipine and Naltrexone. You also have to give it a lot of credit to our manufacturing lab and quality personnel, as well as our supply chain partners. All have done a phenomenal job ensuring that we continue to run on all cylinders producing record volumes, shipping record volumes and all of this during the current Covid pandemic.
So that's quite an achievement, really remarkable what everybody has done. The other parts of our revenues are profits splits and those we earn as our marketing partners sell into the market. These depend on the timing of their in market sales so there's a natural lag of a few quarters up to even four or could even be six quarters from when we manufacture to when those in market sales are achieved. And when we earn those profit split revenues. So profit splits, they're up from $2.2 million in 2019 to $3.5 million this year. So that's a $1.3 million increase or 59%. So you notice there's a lower rate of increase in profit splits as compared to manufacturing revenues. And this is due to the timing lag I just mentioned between the two types of revenues especially since the extended-release Adderall was launched during the last month of the year. So we ship launched quantities during March 2020, but other than a $375,000 milestone earned when we launched the product, will be earning the profit split revenues as our marketing partner which is Lannett as they sell it into the market. So it takes a few quarters after the product launch for the profit splits to start coming online.
So immediate release Adderall and Dantrolene were launched earlier in the fiscal year, fiscal 2020. So they've already started to positively impact on profit split revenues. And amphetamine, the Adderall extended release has not yet impacted profit split revenues because they were launched right at the end of the year. But we do expect additional contribution from the extended release Adderall as those profit splits start to come online over the next few quarters. So you put the increases in both manufacturing revenues and profit split together, you get total revenues going up from $7.6 million to $18 million in a single year. So before moving on, I think it's important to keep in mind that extended release Adderall has just been launched and the immediate release version of Adderall as well as Dantrolene they're both relatively new in the market.
Our marketing partner has done a great job with all of these products, but there's still room for growth in the future. So moving down the P&L, we come to research and development expenses, which went down from $7.6 million last year 2019 to $5.5 million this year fiscal 2020. That's a $2.1 million decrease or 28%. As I've always said there are two things to always keep in mind when it comes to R&D expenses. First is that R&D is the lifeblood of any pharmaceutical company. A large part of the $7.6 million that we spend in 2019, they went to the products that were launched in early 2020 and part of the $5.5 million spent this year in 2020 also went to the product that we launched at the very end of fiscal 2020.
https://seekingalpha.com/article/4356443-elite-pharmaceuticals-inc-eltp-ceo-nasrat-hakim-on-q4-2020-results-earnings-call-transcript?page=2
ELTP$$$$$$$$
Trenbolone Enanthate Market Global Industry Analysis, Size, Share, Growth, Trends and Forecast (2020 – 2027)
Post author
By purushottam
Post date
July 9, 2020
Leading Trenbolone Enanthate manufacturers/companies operating at both regional and global levels:
Globalanabolic
ARL Russia
OLYMP Labs
Dragon Pharmaceuticals
Elite Pharmaceuticals
Kalpa Pharmaceuticals
SP Laboratories
Alpha Pharma
Labdhi Pharmaceuticals
Genesis Pharmaceuticals
https://coleofduty.com/news/2020/07/09/trenbolone-enanthate-market-global-industry-analysis-size-share-growth-trends-and-forecast-2020-2027/
https://menafn.com/1099536629/Global-Trenbolone-Enanthate-Market-2020-With-Top-Countries-Data-Market-Size-Concentration-Rate-Production-Volume-Price-Gross-Margin-and-Revenue
ELITE PHARMACEUTICALS, INC. (OTCMKTS:ELTP) Files An 8-K Entry into a Material Definitive Agreement
ByME Staff 8-k -July 10, 2020
Thereafter, under the Purchase Agreement, the Company may direct Lincoln Park to purchase up to 500,000 shares of Common Stock on such business day (each, a “Regular Purchase”), provided, however, that (i) the Regular Purchase may be increased to up to 600,000 shares, provided that the closing sale price of the Common Stock is not below $0.15 on the purchase date; (ii) the Regular Purchase may be increased to up to 700,000 shares, provided that the closing sale price of the Common Stock is not below $0.20 on the purchase date; (iii) the Regular Purchase may be increased to up to 800,000 shares, provided that the closing sale price of the Common Stock is not below $0.25 on the purchase date; and (iv) the Regular Purchase may be increased to up to 900,000 shares, provided that the closing sale price of the Common Stock is not below $0.30 on the purchase date. In each case, Lincoln Park’s maximum dollar commitment in any single Regular Purchase may not exceed $1,000,000. The purchase price per share for each such Regular Purchase will be based on an agreed upon fixed discount to the prevailing market prices of the Company’s Common Stock immediately preceding the time of sale. In addition to Regular Purchases, the Company may also direct Lincoln Park to purchase other amounts as accelerated purchases and as additional accelerated purchases if the closing sale price of the Common Stock is not less than $0.03 per share at such times as set forth in the Purchase Agreement. There are no upper limits on the price per share that Lincoln Park must pay for shares of Common Stock. The above-referenced share amount limitations and closing sale price thresholds are subject to adjustment for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction as provided in the Purchase Agreement.
The net proceeds under the purchase agreement to the Company will depend on the frequency and prices at which the Company sells shares of its stock to Lincoln Park. The Company expects that any proceeds received by the Company from such sales to Lincoln Park will be used for research and product development, general corporate purposes and working capital requirements.
https://marketexclusive.com/elite-pharmaceuticals-inc-otcmktseltp-files-an-8-k-entry-into-a-material-definitive-agreement-9/2020/07/
Nasrat Hakim
Okay. Thank you, Carter. Next question is on increased and authorized, was the increase in shares issued related to CEO holding and how can you guarantee investors that further dilution will not happen?
A part of it was due to the Series J. But the other parts were for us to have the ability to have to conclude business opportunities similar to the one I just explained to with SunGen. If these shares were available and they were presented and we could actually catch them out we would have had a very good deal with a company, which had a lot of product in that pipeline including some that are first to file and [paragraph] for filings. You always need the ability to maneuver otherwise we continue producing very little and taking that very little first getting to the point of breaking even and then maybe a little bit profitable and that little im-profitability will take us forever to get one product through the market. And maybe one of these days we should have a Board with the stockholders if that's the rate that we need to go on that's the rate we have to go on. But for us, to go after new products and get the companies next level and increase revenues and all the things that people ask me to do, and do it with nothing that's asking a little too much. So, yes, there is a potential that we may be using some of these shares but anything we use is for Elite benefit and for the stockholders benefit, okay. Nothing extravagant. It's all R&D related that we hope the return on the investment will be several folds once the R&D succeeds.
https://seekingalpha.com/article/4356443-elite-pharmaceuticals-inc-eltp-ceo-nasrat-hakim-on-q4-2020-results-earnings-call-transcript?page=6
On March 31 ELTP announced its marketing partner Lannett Company, Inc. has commenced product launch of Elite’s generic version of Adderall XR®, an extended-release mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate) with strengths of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg capsules. Adderall XR®, including generic versions, have an estimated IQVIA™ market value of approximately $1.3 billion for the twelve months ending January 2020. Adderall XR® is a once-daily central nervous system stimulant and is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
This generic Adderall XR® product is jointly owned by Elite and SunGen Pharma LLC and is the second product launched from their collaboration. Elite will manufacture and package the generic product on a cost-plus basis. Lannett Company, Inc. will be the exclusive U.S. distributor for the product and will provide sales, marketing, and distribution.
https://microcapdaily.com/everyone-is-talking-about-elite-pharmaceuticals-inc-otcbbeltp/125712/
ELTP$$$$
Currently trading at a $66 million market valuation ELTP is an exciting story developing in small caps with a number of FDA approved drugs already on the market as well as many more in the pipeline in various stages with numerous partners reporting significant sales of $18 million for fiscal 2019 and already $7 million for Q1 2020. The fast rise in revenues on ELTP was largely attributed to revenues from products launched during the 2020 Fiscal Year, generic immediate release Adderall®, generic extended release Adderall®, and generic Dantrolene Capsules, as well as strong growth in revenues relating to the sales of Isradipine capsules. We will be updating on ELTP when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with ELTP.
https://microcapdaily.com/the-buzz-on-elite-pharmaceuticals-inc-otcbbeltp/126297/
Elite Pharmaceuticals, Inc. (ELTP) CEO Nasrat Hakim on Q4 2020 Results - Earnings Call Transcript
Since Adderall XR has launched, has the DEA quota issue been worked out or normalized?
Yes, it has. The DEA was kind enough to give us quota through the end of the year. Now that doesn't mean I have product. I need you to understand that quota means they allow me to buy it. Now I have to work with the API supplier whom they all want upfront cash and the product is extremely expensive and by that bring it in-house test it and then make a product from it. Then sent it to Lannett and that's transfer price 30 days later they pay us. So there is a lot of money that is tied up in working capital when you do something like this. The step one which is a very, very good step is to have approval from the government to do it. Step two now you got to have the money to do it and such thing you got to wait till you get money back so the cycle starts over again, okay.
Following the approval of some [Indiscernible] there was discussion about the DEA quota issues that we just addressed that, okay, there's no issue here.
SunGen Elite Adderall AR, what is going on with transferring the end from SunGen's name to Elite, okay. We did that because Mika took over and as SunGen requested that before actually, it was in the works but when Mika took over we told [Duleep] go ahead and do that, okay. Mainly because of the transfer of the product, okay.
The two antibiotics. Can you please provide an update on the co development of antibiotics?
SunGen suppose to have them the name, we're working very closely with them in order to find a resolution to these. They don't invest any more money and they don't even invest money in even trying to launch a product. So we got to come up with something that's a win-win for both parties. We are working on that.
CNS, ANDA, what is the status of SunGen partnership CNS, ANDA with the potential of $1.5 billion market?
As it would require a bio equivalency trial before submitting and we were led to believe this effort was on the front burner. Why the delay? Well, the delay is because SunGen is not putting in any money. So I reached an agreement with SunGen that we will take over this product. We have no further obligation to them. We are going to develop it to a point where we can run a clinical trial. And it will be 100% Elite's product. We are separating ourselves from SunGen. This product will be going forward all they know how will be ours. We are exploring its viability right now and once we get to a point where there is a milestone will notify you of that.
Luxopine, update on Luxopine launch. We just did that.
Since Adderall XR has launched, has the DEA quota issue been worked out or normalized?
Yes, it has. The DEA was kind enough to give us quota through the end of the year. Now that doesn't mean I have product. I need you to understand that quota means they allow me to buy it. Now I have to work with the API supplier whom they all want upfront cash and the product is extremely expensive and by that bring it in-house test it and then make a product from it. Then sent it to Lannett and that's transfer price 30 days later they pay us. So there is a lot of money that is tied up in working capital when you do something like this. The step one which is a very, very good step is to have approval from the government to do it. Step two now you got to have the money to do it and such thing you got to wait till you get money back so the cycle starts over again, okay.
Following the approval of some [Indiscernible] there was discussion about the DEA quota issues that we just addressed that, okay, there's no issue here.
SunGen Elite Adderall AR, what is going on with transferring the end from SunGen's name to Elite, okay. We did that because Mika took over and as SunGen requested that before actually, it was in the works but when Mika took over we told [Duleep] go ahead and do that, okay. Mainly because of the transfer of the product, okay.
The two antibiotics. Can you please provide an update on the co development of antibiotics?
SunGen suppose to have them the name, we're working very closely with them in order to find a resolution to these. They don't invest any more money and they don't even invest money in even trying to launch a product. So we got to come up with something that's a win-win for both parties. We are working on that.
CNS, ANDA, what is the status of SunGen partnership CNS, ANDA with the potential of $1.5 billion market?
As it would require a bio equivalency trial before submitting and we were led to believe this effort was on the front burner. Why the delay? Well, the delay is because SunGen is not putting in any money. So I reached an agreement with SunGen that we will take over this product. We have no further obligation to them. We are going to develop it to a point where we can run a clinical trial. And it will be 100% Elite's product. We are separating ourselves from SunGen. This product will be going forward all they know how will be ours. We are exploring its viability right now and once we get to a point where there is a milestone will notify you of that.
Luxopine, update on Luxopine launch. We just did that.
Since Adderall XR has launched, has the DEA quota issue been worked out or normalized?
Yes, it has. The DEA was kind enough to give us quota through the end of the year. Now that doesn't mean I have product. I need you to understand that quota means they allow me to buy it. Now I have to work with the API supplier whom they all want upfront cash and the product is extremely expensive and by that bring it in-house test it and then make a product from it. Then sent it to Lannett and that's transfer price 30 days later they pay us. So there is a lot of money that is tied up in working capital when you do something like this. The step one which is a very, very good step is to have approval from the government to do it. Step two now you got to have the money to do it and such thing you got to wait till you get money back so the cycle starts over again, okay.
Following the approval of some [Indiscernible] there was discussion about the DEA quota issues that we just addressed that, okay, there's no issue here.
SunGen Elite Adderall AR, what is going on with transferring the end from SunGen's name to Elite, okay. We did that because Mika took over and as SunGen requested that before actually, it was in the works but when Mika took over we told [Duleep] go ahead and do that, okay. Mainly because of the transfer of the product, okay.
The two antibiotics. Can you please provide an update on the co development of antibiotics?
SunGen suppose to have them the name, we're working very closely with them in order to find a resolution to these. They don't invest any more money and they don't even invest money in even trying to launch a product. So we got to come up with something that's a win-win for both parties. We are working on that.
CNS, ANDA, what is the status of SunGen partnership CNS, ANDA with the potential of $1.5 billion market?
As it would require a bio equivalency trial before submitting and we were led to believe this effort was on the front burner. Why the delay? Well, the delay is because SunGen is not putting in any money. So I reached an agreement with SunGen that we will take over this product. We have no further obligation to them. We are going to develop it to a point where we can run a clinical trial. And it will be 100% Elite's product. We are separating ourselves from SunGen. This product will be going forward all they know how will be ours. We are exploring its viability right now and once we get to a point where there is a milestone will notify you of that.
Luxopine, update on Luxopine launch. We just did that.
https://seekingalpha.com/article/4356443-elite-pharmaceuticals-inc-eltp-ceo-nasrat-hakim-on-q4-2020-results-earnings-call-transcript?page=7
Thanks for sharing Gman24.
Nice read
Earlier this year ELTP announced its marketing partner Lannett Company, Inc. has commenced product launch of Elite’s generic version of Adderall XR®, an extended-release mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate) with strengths of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg capsules. Adderall XR®, including generic versions, have an estimated IQVIA™ market value of approximately $1.3 billion for the twelve months ending January 2020. Adderall XR® is a once-daily central nervous system stimulant and is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). This generic Adderall XR® product is jointly owned by Elite and SunGen Pharma LLC and is the second product launched from their collaboration. Elite will manufacture and package the generic product on a cost-plus basis. Lannett Company, Inc. will be the exclusive U.S. distributor for the product and will provide sales, marketing, and distribution.
On June 29 ELTP announced results for the fiscal year ended March 31, 2020. Consolidated revenues for Fiscal 2020 were $18.0 million, an increase of $10.4 million or approximately 137% from the comparable period of the prior fiscal year. The increase in revenues was largely attributed to revenues from products launched during the 2020 Fiscal Year, generic immediate release Adderall®, generic extended release Adderall®, and generic Dantrolene Capsules, as well as strong growth in revenues relating to the sales of Isradipine capsules.
Currently trading at a $66 million market valuation ELTP is an exciting story developing in small caps with a number of FDA approved drugs already on the market as well as many more in the pipeline in various stages with numerous partners reporting significant sales of $18 million for fiscal 2019 and already $7 million for Q1 2020. The fast rise in revenues on ELTP was largely attributed to revenues from products launched during the 2020 Fiscal Year, generic immediate release Adderall®, generic extended release Adderall®, and generic Dantrolene Capsules, as well as strong growth in revenues relating to the sales of Isradipine capsules. We will be updating on ELTP when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with ELTP
https://microcapdaily.com/the-buzz-on-elite-pharmaceuticals-inc-otcbbeltp/126297/
22,4,2
Good luck Everyone!
In addition, we were very concerned about amphetamine IR and ER who are they can divest to and what's going to happen. Their CEO and I entered into negotiations to acquire SunGen at least the R&D solid doses line. SunGen have also an injectable division. We reached an agreement and decided to approach our boards with it. The offer was 100% in stock, the CEO accepted it. He saw it as a very good thing for the company. He thought that they'll be an upside when they get our stocks is then that it's going to go up with all these new products we'll be getting. But their board rejected it because they do not understand the -- stock and restrictions that comes with it. In the meantime, SunGen was also negotiating with other Chinese firms to acquire them. We had the first shot at it and the board did not accept a 100% stock offer.
They offered Elite to buy amphetamine IR and ER but insisted also on 100% in cash. I called the Board meeting. Mr. Ward informed us that we cannot afford to spend that kind of money on new products. We do not have it and we cannot raise it. After Elite rejected the offer that's how Mika ended up with the enders by stepping in. It is my hope that eventually Elite will end up with these two products. Okay. A question from the stockholders as why there was no 8-K and the answer is simple; this transaction was between two privately held companies after Elite was given the right of first refusal and rejected the offer. Further, there is no impact on Elite. The impact on Elite really for this transaction is zero. All Mika is step into SunGen's shoes, that's it. That had no impact on Elite whatsoever. As a matter of fact there are positive impacts on Elite that I will not go through in here today. That did not require an 8-K but we did publish this event as a part of our 10-K. We included it in detail in our 10-K.
There were several questions about this subject and I hope I covered them all. So I'll move on to others and I'll circle back to this. The questions really were coming in after just few minutes ago from Dianne because of the delay in the SEC. Yesterday they had some technical issues and they could not get the 10-K out so every question Dianne gave me up till the last second, I have try to add it to my presentation, group it with others or addressed separately. The first question is please explain the following timeline and Carter just went through that. The accelerated filing and the status on all of this. There is no need for me to repeat all of that.
Can you provide guidance for Q1, 2021 which is this quarter? Please provide some type of forecast for the next few quarters as we haven't had much information in the last five months.
I will share with you what I know and that is the quarter ending today we will hit the $7 million in revenues and that quarter would not have any profit splits from the ER, is that right, Carter? We don't see any profit splits this quarter.
Carter Ward
No. There should be some.
Nasrat Hakim
Yes, very minimal because of the launch, okay. So the quarter will end today. We will hit the $7 million. The last quarter was almost $5 million.
Carter Ward
Just under $5 million.
Nasrat Hakim
Okay. I expect the same funds for next quarter, but as I just told you we are going through a pandemic. I cannot make you promises that I cannot keep. And we don't run sales or marketing therefore I can't give you projections. All I can do is when Lannett gives me a solid projection for what they want us to make for three months, I would have a good sense what am I going to make during these months. But beyond that the schedule keeps changing, okay.
How is the company progressing on the needed update for internal control measures? What will still be needed to take place?
https://seekingalpha.com/article/4356443-elite-pharmaceuticals-inc-eltp-ceo-nasrat-hakim-on-q4-2020-results-earnings-call-transcript?page=5
un 24, 2020
Elite Pharmaceuticals, Inc. To Host Conference Call To Provide Corporate Update And Discuss Year-End Financial Results On June 30, 2020
Financials for Fiscal Year Ended March 31, 2020 will be released June 29, 2020
NORTHVALE, NJ / ACCESSWIRE / June 24, 2020 / Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCQB:ELTP), a specialty pharmaceutical company developing niche generic products, announced today that its 2020 year-end financial results will be released on Monday, June 29, 2020. Elite's management will host a live conference call on Tuesday, June 30 at 11:30 AM EDT to discuss the company's financial and operating results and provide a general business update. Stockholder questions should be submitted to the company in advance of the call.
Conference Call Information
Date: June 30, 2020
Time: 11:30 AM EDT
Dial- in numbers:
1-800-346-7359 (domestic)
1-973-528-0008 (international)
Conference number: 98840
Questions:
General questions by 5:00 PM EDT on Sunday, June 28, 2020
Financial questions by 7:00 AM EDT on Tuesday, June 30, 2020
Email to: dianne@elitepharma.com
Audio Replay:
https://elite.irpass.com/events_presentations
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company which is developing a pipeline of proprietary pharmacological abuse-deterrent opioid products as well as niche generic products. Elite specializes in oral sustained and controlled release drug products which have high barriers to entry. Elite owns generic products which have been licensed to TAGI Pharma, Glenmark Pharmaceuticals, Inc., USA., and Lannett Company, Inc. Elite currently has eleven approved generic products, three generic products filed with the FDA, one approved generic products pending manufacturing site transfer, and an NDA filed for SequestOx™. Elite's pipeline products include abuse-deterrent opioids which utilize the Company's patented proprietary technology These formulations are intended to address two major limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential opioid abuse. Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ. Learn more at www.elitepharma.com. The information found on Elite's website is not incorporated by reference into this press release and is included for reference purposes only.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Including those related to the effects, if any, on future results, performance or other expectations that may have some correlation to the subject matter of this press release, readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, Elite's ability to obtain FDA approval of the transfers of the ANDAs or the timing of such approval process, delays, uncertainties, inability to obtain necessary ingredients and other factors not under the control of Elite, which may cause actual results, performance or achievements of Elite to be materially different from the results, performance or other expectations that may be implied by these forward-looking statements. These forward-looking statements may include statements regarding the expected timing of approval, if at all, of SequestOx™ by the FDA, and the actions the FDA require of Elite in order to obtain approval of the NDA. These forward-looking statements are not guarantees of future action or performance. These risks and other factors, including, without limitation, Elite's ability to obtain sufficient funding under the LPC Agreement or from other sources, the timing or results of pending and future clinical trials, regulatory reviews, and approvals by the Food and Drug Administration and other regulatory authorities and intellectual property protections and defenses, are discussed in Elite's filings with the Securities and Exchange Commission, including its reports on forms 10-K, 10-Q, and 8-K. Elite is under no obligation to update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.
Contact:
For Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations, 518-398-6222
Dianne@elitepharma.com
www.elitepharma.com
Site Map | Privacy | Terms Of Use
Copyright © 2020 Elite Pharmaceuticals Inc. | All Rights Reserved. ART™: Abuse-Resistant Technology for a safer healthier you.
Privacy
Everyday FF wink
You may be right on the employees broken up into 2 shifts bc of the coronavirus situation.....however, they did add more employees since last year....As of June 15, 2020, Elite has 43 full time employees. As of June 14, 2019, Elite had 35 full time employees. My understanding is they never had a second shift until recently coinciding with Elite manufacturing and packaging Adderall IR/ER for Lannett.
SunGen....I'd have to go back over the CC again but my understanding is Mikah purchased Adderall IR and ER from SunGen and thus is in Elite's hands. The other two antibiotics are confusing....SunGen has no more money for launching them....I'm uncertain if they've even been filed with the FDA yet? However, Nasrat made it sound like Elite will own these as well. Then you come to the CNS generic....the big dog as it were. Elite is going to own this product as well but it requires some decent capital to run a trial and then file. So some good and bad news imo related to SunGen.
Thank you Couch.
In the House!!
These numbers look solid on a year to year comparison. And $7 million in revenues next quarter compared to $5 million this quarter. And if I'm not mistaken, they don't include Adderall XR this current quarter which should be a bigger product than Adderall IR moving forward. They might just hit cash flow positive this year. Did I fail to mention Elite just added a second shift to the manufacturing and packaging line. That spells increased revenue all over it.
For the Year Ended March 31,
2020 2019
NDA:
Licensing fees $ 1,000,000 -- $1,000,000
Total NDA revenue 1,000,000 -- 1,000,000
ANDA:
Manufacturing fees $ 14,526,048 -- $5,387,696
Licensing fees 2,468,591 -- 1,180,812
Total ANDA revenue. 16,994,639 -- 6,568,508
Total revenue $ 17,994,639 -- 7,568,508 (edited)
All sales? I see all buys. Of course to have a buyer you need a seller. The advantage of sitting below the bid. Thank you!
ELTP$$$$$
FDA and Elite working very close together.
Nasrat Hakim
Thank you, Carter. What a difference a year makes. An increase in revenue from $7.6 million to $18 million is a solid step in the right direction, becoming profitable enough to support an R&D pipeline would get us to the right destination. That is where we want to be. An essential part of growth is to also hold on to what you have. We are working with our partner Lannett to protect our current shares of the market and ensure that we grow it. Lannett is in charge of sales and marketing and they have done a very good job with the market shares for the IR in spite of the fact that it's a saturated market with 11 players. We trust they'll do the same thing with amphetamine ER. From our side, Elite is protecting and improving the business by ensuring that our GMP facility has the right capacity, equipment, material and personnel to support Lannett and our other sales and marketing partners.
We secured enough API quota from the DEA to support Lannett's sales projections through the end of this year. That is fantastic news. We struggled with that in the first quarter and a little bit in the second and finally the DEA came around and gave us enough quota to support the sales and marketing projections through the end of the year. In March, Elite was inspected by the FDA again for Pharmacovigilance and REMS. After eight day inspection the FDA issued a minor observation on a Form 483. The observation was for our website not having a link to REMS for [Indiscernible]. We explained to the FDA that the product is not and has never been marketed or commercialized. Further the link on the website to the REMS was corrected three days before. They issued the observation that did not help. We still got a minor observation but the FDA was kind enough to annotate that it was corrected before they left.
Regardless, this is a great outcome and outstanding news. That makes five inspections, four of which we got zero observations and one that we got this Mickey Mouse observation for. Elite has also successfully pivoted away from opioids during the opioid crisis and the negative environment and lawsuits that came with it and we are extremely lucky that we have never been a part of that. Elite is executing on its growth plan, getting product approvals and launching new products. And our sales and marketing partners Glenmark, TAGI and Lannett are all performing well.
Elite Pharmaceuticals, Inc. (ELTP) CEO Nasrat Hakim on Q4 2020 Results - Earnings Call Transcript
https://seekingalpha.com/article/4356443-elite-pharmaceuticals-inc-eltp-ceo-nasrat-hakim-on-q4-2020-results-earnings-call-transcript?page=3
I was thinking 7.3 million. Seven will work . Hell yeahhh
ELTP
They jumped in quick.
ELTP$$$$
18,11,19
Good Luck Everyone!
9,4,18
Good Luck Everyone!
GTSM---This is a newly formed market maker, that most have not noticed.
What makes them special is, they have institution clients in addition to OTC clients... camouflage for the whales.
Interesting
2,22,12
Good luck Everyone!
The Adderall generic version paves the way for Elite and SunGen to flex their muscle in a market worth millions of dollars, given that the branded version generated sales of $365 million as of September of last year.
https://insiderfinancial.com/elite-pharmaceuticals-inc-otcmktseltp-bulls-defend/178191/
Radar looks good the rest of the evening at the moment anyway.
Looks like a night race, Vexari.
Thanks for sharing the video. Excellent story behind this band.
Raw Talent for sure.
Cheers