working 24/7
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
19,4,11 Playoff-19
Good Luck Everyone!
Thank you, Gap
Good Luck!
Can you guys change my 11 to the 2 car please. Thank you.
18,4,11
Playoff 18
Good Luck Everyone!
We've averaged quarterly revenue growth of 155% as compared to the comparable quarter of the prior year.
Carter Ward, CFO
Thank you, Nasrat and thanks to everyone as always for calling in today. Last Friday, August 14, 2020, we filed our 10-Q for the quarter ended June 30, 2020. So we're on a March fiscal year that means the June quarter is the first quarter of our 2021 fiscal year. The Q is available on the Investor section of our website, which is elitepharma.com, as well as sec.gov and other websites that provide links to our filings. We haven't gone through the Q yet, please get a copy from elitepharma.com or any of the other sites.
Today, I'd like to review some of the key parts of the financials, providing analysis, context and insight into the numbers. As always, we've received questions and comments from shareholders and Elite followers. I'll do my best to address those questions that are related to the financials.
Let's start with the P&L, where we reported our highest-to-date quarterly revenues. Revenues for the quarter ended June 2020 was $7.5 million and that's compared to $3.4 million for the June 2019 quarter, that's a $4.2 million increase or 124% as compared to the last -- same quarter of last year. The increase was driven by revenues from generic extended release Adderall, which was launched on March 30 of this year and we also saw strong growth as compared to last year for the generic immediate release Adderall, Isradipine and Phentermine as well. Also our Naltrexone product has been a steady performer contributing consistent numbers to revenues.
The June 2020 quarter was clearly a very strong one for Elite, it's also the fifth consecutive quarter of double or triple digit revenue growth compared to the comparable quarter of the prior year. Over the last five quarters, encompassing the four quarters of the 2020 fiscal year, plus the first quarter of this 2021 fiscal year, we've averaged quarterly revenue growth of 155% as compared to the comparable quarter of the prior year.
Over the same five-quarter period, when looking on a quarter-to-quarter basis, we have increased our revenues in four of the five quarters, with an average revenue increase of almost 50%, that's quarter-to-quarter. All of our product lines are contributing to this growth, but there is three product lines that particularly standout based not just on the numbers, which are retrospective, but also on the prospective factors as well. Those three products are generic immediate release Adderall, generic extended release Adderall and Isradipine. All three have significant -- significantly contributed to our growing revenues and all three also show future upside potential.
Generic extended release Adderall has been in the market for slightly more than one quarter, having been launched on March 30 of this year. Generic, immediate release Adderall was launched during the June 2019 quarter, so that product has been in the market for just over one year. Both products still have future upside as our alliance partner Lannett continues its penetration of the market. Lannett to date has done an excellent job establishing these products and should we expect -- should continue expanding the market share.
Isradipine is a product with a relatively small market size, but competitive factors predict future upside in Isradipine that would provide contributions to Elite's results above their current levels. The takeaway from our revenues is that we not only achieved record revenues more than doubling the prior year and our fifth consecutive quarterly increase, but the products responsible for most of the growth have the potential for even more future upside.
Much of the credit for Elite's strong performance is due to its manufacturing lab and quality personnel, as well as marketing and supply chain partners. They have all done a phenomenal job ensuring we continue to run on all cylinders producing record volumes, record revenues and all during the COVID-19 pandemic.
Moving down the P&L to the operating income line, you'll see we had an operating profit of 830,000 for the quarter and that's as opposed to a loss of $1.1 million in the prior year. So that's just under a $2 million improvement in profitability on a year-to-year basis. The balance sheet specifically, receivables, payables and inventories provide some context and visibility into how this turnaround is reflected in our financials. Since March 2020, our receivables have increased by $300,000 and our inventories were up $1.4 million, both are indicative of growing revenues. We need to buy and stock more inventory to meet the growing demand and our receivables are naturally higher due to increased billings to customers. On the payables and accruals side, those are also up by approximately $240,000, natural to expect those to increase with operations in revenues but note that the increase in these items is less than the increase in inventories and receivables. This shows the strengthening of our working capital position that results from operating profits on our P&L statement, as well as the positive operating cash flow, which is reported on our cash flow statement.
Finally, on our balance sheet, our overall equity increased by $1.1 million since March 31, almost all of this was due to our net income, which includes the operating income of $800,000 combined with other income and expense items such as derivatives and sales of our state NOLs. So, however, you look at it the financial metrics and ratios they're all moving in a positive direction.
https://seekingalpha.com/article/4369319-elite-pharmaceuticals-inc-eltp-ceo-nasrat-hakim-on-q1-2021-results-earnings-call-transcript?page=2
Elite Pharmaceuticals, Inc. (ELTP) CEO Nasrat Hakim on Q1 2021 Results - Earnings Call Transcript
Aug. 17, 2020 4:45 PM ET
Chairman and CEO and President, Mr. Nasrat Hakim would like to give an update and his comments.
So let's look at the industry and see what's going on in the industry, generic industry, we're not talking about the brand Pfizer's and others, we are talking about the generic industry. Looking at the generic industry for the past five years and naming just about any company you can think of, starting with the largest company in the world, Teva Pharmaceutical, which acquired Actavis and Watson the other two largest companies in the world was $65 five years ago, today it's $12.
They have a negative P/E ratio and there they have no earnings per share, actually they do lose $0.07, $0.08 per share. The company's market cap is about $12 billion to $13 billion and they owe about $26 billion. This is a little bit like a person who owns a house that's worth $100,000 and they have a mortgage on it for $200,000, $300,000. The best company of all these -- almost dozen I'm going to go through is Dr. Reddy. Dr. Reddy was $65 five years ago and they are about $60 today, not a lot loss over five years and most of it's really gained within last year and they have a P/E ratio, actually they have earnings per share of 40.
At Sandoz, they dissolve their generic decision, they were at one time the biggest and they became the second biggest and they dissolved the generic business. Mylan, $54 five years ago, $16 today, they also have the P/E ratio, [indiscernible] bankrupt, Amneal they purchased impacts and $350 million worth of product from Watson and they were $45 to go -- they are $4 today and they operate at the loss negative P/E ratio. Valeant $250 down to $17 operating at a negative P/E ratio. Paragon 200 down to $50, Endo Pharmaceutical $80, that's 80 down to 3 bucks. Lannett, I think the whole of Lannett, they are doing an outstanding job for us, they were $50 five years ago, they are $6 today, again negative earnings.
Akorn $20 five years ago, $0.12 today. Insys pharmaceutical $30 five years ago, $0.04 today. The consolidation in the pharmaceutical industry and the time we have gone through have been very rough. You know, everybody wants to hear that our stock is going through the roof and making money and that is the best news for me that I could ever share with you and with my family. But the sector as a sector has been suffering and little Elite not only not go bankrupt, we survived, we have our lights on, we pay our employees, we comply with FDA requirements, DEA requirements, offshore requirements, as I said we meet payroll and we're thriving.
We have shifted to becoming profitable, we still fund companies to make deals with such as SunGen and others in order for us to survive and now we've reached profitability and the outlook looks really positive considering that ER is in its infancy with respect to the product life cycle, hopefully we will max out maybe in two to three years and start to see where it's going to settle then, but as of now everything looks good for us. So, are we more soft in the generic industry? I would say no. Are we worse off if we diluted the company than borrowing -- if we are borrowing money from a lender that comes after us, no, we would not exist today if we did that.
With all of that, we're a small company and we're on the OTC. Obviously our stock gets manipulated. We have low volumes, when you have 500,000 shares changing hands at $0.06 a share or $0.07 a share, that's $30,000, $35,000 anybody with fair brand can manipulate the heck out of the company. That's why I keep talking about creating fundamentals and getting the heck of the Bulletin Board and the OTC and moving on to the place where we have institutional investors coming in.
As I mentioned and so this quarter, we've had five quarters in a row where we have done very well and yet the stock did not move. That pressure is building up and I do believe sooner or later we are going to take off.
Let me say in conclusion that we are in the best financial shape ever and we are doing better than most in the industry. We've stabilized the company, we have solid manufacturing facility with excellent GMP compliance and history and financial sources through our profitability and Lincoln Park Capital, we have an avenue to buy products, work with partners or go at by ourselves for R&D.
We are profitable and targeting sustained profitability. We have $75 million in federal tax credit, meaning that the first $75 million that we earn we don't pay taxes on. We have very little debt. If you look at our debt-to-market cap, we're running at about 7%, if you look at Teva, they're running at 200%. Our profitability and Lincoln Park deal are critical factors and our investing in R&D. The list I just went through is our vehicle to NASDAQ, makes us very appealing for somebody to buy us out or for us to merge with another company's sales and marketing or of the sort and continue. The news has been fantastic in spite of the stock has not moved in the past, I have -- I have no remedy for that, I don't have the magic wand for me to get the stock up, all I have is our hard work, continuing to get the best deal for Elite, to ensure that we will get to where we're going.
https://seekingalpha.com/article/4369319-elite-pharmaceuticals-inc-eltp-ceo-nasrat-hakim-on-q1-2021-results-earnings-call-transcript?page=7
22,2,12
Good Luck Everyone!
Maybe a positive leak? We will see.
ELTP$$$$
LAFC = marketmaker R. F. Lafferty & Co., Inc.
Their Investment Banking services include:
* Mergers and Acquisitions
* Reverse Mergers
* PIPE Transactions
* Private Placements
* Initial Public Offerings
* Bridge Financing
* Assistance with Exchange Listings
ELTP$$$$$$$
Thanks Cap Have a excellent week.
4,19,11
Good Luck Everyone!
19,4,11 Saturday
Good Luck Everyone!
Yes, It is very obvious the PPS is being manipulated.
CEO Nasrat,
With all of that, we're a small company and we're on the OTC. Obviously our stock gets manipulated. We have low volumes, when you have 500,000 shares changing hands at $0.06 a share or $0.07 a share, that's $30,000, $35,000 anybody with fair brand can manipulate the heck out of the company. That's why I keep talking about creating fundamentals and getting the heck of the Bulletin Board and the OTC and moving on to the place where we have institutional investors coming in.
As I mentioned and so this quarter, we've had five quarters in a row where we have done very well and yet the stock did not move. That pressure is building up and I do believe sooner or later we are going to take off.
Let me say in conclusion that we are in the best financial shape ever and we are doing better than most in the industry. We've stabilized the company, we have solid manufacturing facility with excellent GMP compliance and history and financial sources through our profitability and Lincoln Park Capital, we have an avenue to buy products, work with partners or go at by ourselves for R&D.
We are profitable and targeting sustained profitability. We have $75 million in federal tax credit, meaning that the first $75 million that we earn we don't pay taxes on. We have very little debt. If you look at our debt-to-market cap, we're running at about 7%, if you look at Teva, they're running at 200%. Our profitability and Lincoln Park deal are critical factors and our investing in R&D. The list I just went through is our vehicle to NASDAQ, makes us very appealing for somebody to buy us out or for us to merge with another company's sales and marketing or of the sort and continue. The news has been fantastic in spite of the stock has not moved in the past, I have -- I have no remedy for that, I don't have the magic wand for me to get the stock up, all I have is our hard work, continuing to get the best deal for Elite, to ensure that we will get to where we're going.
https://seekingalpha.com/article/4369319-elite-pharmaceuticals-inc-eltp-ceo-nasrat-hakim-on-q1-2021-results-earnings-call-transcript?page=7
We are working on central nervous system product..
Exciting times!
CEO Nasrat,
Elite is executing on its growth plan, getting product approvals and launching new product. And our sales and marketing partner Lannett is doing great job and TAGI and Glenmark are doing as well. In development, we are working on central nervous system product that we have discussed previously. Let me pause here and make this very clear because I got some questions on that. This product Elite has the know-how and can move forward by itself to optimize the formulation conduct clinical trials and file the product with no obligation to anybody else. We resolved the issues with SunGen and this product now is with Elite.
https://seekingalpha.com/article/4369319-elite-pharmaceuticals-inc-eltp-ceo-nasrat-hakim-on-q1-2021-results-earnings-call-transcript?page=5
25% more capacity. Revenues still growing in my opinion
CEO Nasrat,
Now due to the limited working capital we placed orders with the API supplier that will be staggered and delivered to us on monthly basis. Our facility is in a very good shape. We have a very nice facility that we are very proud of. We will be spending hundreds of thousands of dollars this year on expanding the facility, improvements and upgrades to increase capacity. We purchased a 30 cubic foot re-blended, a new higher speed Tablet Press and upgraded our packaging line, so now it has 25% more capacity. We are utilizing SAP more and more and we hired a full-time employee, an expert in SAP and material management to help us streamline our systems.
https://seekingalpha.com/article/4369319-elite-pharmaceuticals-inc-eltp-ceo-nasrat-hakim-on-q1-2021-results-earnings-call-transcript?page=4
CFO Carter Ward,
The second question relates to the sale of SunGen rights to half of the profit earned from sales of the generic Adderall products, which were negotiated with SunGen as part of the co-development agreement between SunGen and Elite. That co-development agreement is just one facet of some of SunGen's overall business.
SunGen was entitled to sell its rights in the co-development agreement and they will offer these rights to Elite for a cash price equal to 3 times estimated earnings earlier this year. That translates to several million dollars, 3 times the earnings of the profits from Adderall. Elite did not have the cash available to consummate the deal at the time of SunGen's offer and accordingly our Board declined SunGen's offer. Subsequently, Mikah Pharma, which is owned by Nasrat Hakim, offered to buy the rights for the same cash terms offered to Elite. This transaction was consummated between SunGen and Mikah.
Elite's position remains the same as prior to SunGen sale of this asset, Elite will receive the same amount of profit as when SunGen was its partner. SunGen was determined to sell this asset regardless of Elite's position and they could have chosen any partner they desired to sell to. Rather than SunGen selling to a third party, which may have complicated the relationship with Elite, they decided to sell to Mikah.
Certainly from a relationship standpoint, this sale by SunGen to Mikah is a much better situation for Elite then if the assets were sold to a third party. I've also received comments about Elite acquiring full rights of these products and that's something we still hope to achieve in the future, but at this point Elite is not in a position to pay cash for these assets. I can't say that in the future if we are in a position to acquire these rights, it is to Elite's benefit that they are held by our largest shareholder with a demonstrated resolve in Elite's success as opposed to being held by a company that may have other priorities.
https://seekingalpha.com/article/4369319-elite-pharmaceuticals-inc-eltp-ceo-nasrat-hakim-on-q1-2021-results-earnings-call-transcript?page=3
ELTP$$$$
Carter Ward
Thank you, Nasrat and thanks to everyone as always for calling in today. Last Friday, August 14, 2020, we filed our 10-Q for the quarter ended June 30, 2020. So we're on a March fiscal year that means the June quarter is the first quarter of our 2021 fiscal year. The Q is available on the Investor section of our website, which is elitepharma.com, as well as sec.gov and other websites that provide links to our filings. We haven't gone through the Q yet, please get a copy from elitepharma.com or any of the other sites.
Today, I'd like to review some of the key parts of the financials, providing analysis, context and insight into the numbers. As always, we've received questions and comments from shareholders and Elite followers. I'll do my best to address those questions that are related to the financials.
Let's start with the P&L, where we reported our highest-to-date quarterly revenues. Revenues for the quarter ended June 2020 was $7.5 million and that's compared to $3.4 million for the June 2019 quarter, that's a $4.2 million increase or 124% as compared to the last -- same quarter of last year. The increase was driven by revenues from generic extended release Adderall, which was launched on March 30 of this year and we also saw strong growth as compared to last year for the generic immediate release Adderall, Isradipine and Phentermine as well. Also our Naltrexone product has been a steady performer contributing consistent numbers to revenues.
The June 2020 quarter was clearly a very strong one for Elite, it's also the fifth consecutive quarter of double or triple digit revenue growth compared to the comparable quarter of the prior year. Over the last five quarters, encompassing the four quarters of the 2020 fiscal year, plus the first quarter of this 2021 fiscal year, we've averaged quarterly revenue growth of 155% as compared to the comparable quarter of the prior year.
Over the same five-quarter period, when looking on a quarter-to-quarter basis, we have increased our revenues in four of the five quarters, with an average revenue increase of almost 50%, that's quarter-to-quarter. All of our product lines are contributing to this growth, but there is three product lines that particularly standout based not just on the numbers, which are retrospective, but also on the prospective factors as well. Those three products are generic immediate release Adderall, generic extended release Adderall and Isradipine. All three have significant -- significantly contributed to our growing revenues and all three also show future upside potential.
Generic extended release Adderall has been in the market for slightly more than one quarter, having been launched on March 30 of this year. Generic, immediate release Adderall was launched during the June 2019 quarter, so that product has been in the market for just over one year. Both products still have future upside as our alliance partner Lannett continues its penetration of the market. Lannett to date has done an excellent job establishing these products and should we expect -- should continue expanding the market share.
Isradipine is a product with a relatively small market size, but competitive factors predict future upside in Isradipine that would provide contributions to Elite's results above their current levels. The takeaway from our revenues is that we not only achieved record revenues more than doubling the prior year and our fifth consecutive quarterly increase, but the products responsible for most of the growth have the potential for even more future upside.
Much of the credit for Elite's strong performance is due to its manufacturing lab and quality personnel, as well as marketing and supply chain partners. They have all done a phenomenal job ensuring we continue to run on all cylinders producing record volumes, record revenues and all during the COVID-19 pandemic.
Moving down the P&L to the operating income line, you'll see we had an operating profit of 830,000 for the quarter and that's as opposed to a loss of $1.1 million in the prior year. So that's just under a $2 million improvement in profitability on a year-to-year basis. The balance sheet specifically, receivables, payables and inventories provide some context and visibility into how this turnaround is reflected in our financials. Since March 2020, our receivables have increased by $300,000 and our inventories were up $1.4 million, both are indicative of growing revenues. We need to buy and stock more inventory to meet the growing demand and our receivables are naturally higher due to increased billings to customers. On the payables and accruals side, those are also up by approximately $240,000, natural to expect those to increase with operations in revenues but note that the increase in these items is less than the increase in inventories and receivables. This shows the strengthening of our working capital position that results from operating profits on our P&L statement, as well as the positive operating cash flow, which is reported on our cash flow statement.
Finally, on our balance sheet, our overall equity increased by $1.1 million since March 31, almost all of this was due to our net income, which includes the operating income of $800,000 combined with other income and expense items such as derivatives and sales of our state NOLs. So, however, you look at it the financial metrics and ratios they're all moving in a positive direction.
https://seekingalpha.com/article/4369319-elite-pharmaceuticals-inc-eltp-ceo-nasrat-hakim-on-q1-2021-results-earnings-call-transcript?page=2
Minutes from the CC,
CFO Carter Ward:
Finally, there were a couple of questions which I received and I figured -- I'll address them now instead of waiting till Nasrat does the Q&A section. The first question had to do with whether or not there is a ratchet applicable to the Series J preferred stocks and warrants for transactions done with Lincoln Park Capital?
And the answer to that is, there is no ratchet to the Series J preferred stocks or the warrants for Lincoln Park transaction. No ratchet was given in relation to any sales of shares to Lincoln Park under the equity line that was an effect from 2017 to July 1 of 2020. And no ratchet will be given to any sales of shares to Lincoln Park under the most recent Lincoln Park agreement.
The Series J preferred shares and warrants specifically exclude any ratchet from sales of shares to Lincoln Park Capital. To further ensure no ambiguity as to the issue of ratchets, Nasrat Hakim has specifically raised -- waived any ratchets from the Series J preferred shares and the warrants relating to the Lincoln Park transaction. Now waiver is attached to the Q -- the 10-Q it's Exhibit 10.57. So it's a public document.
https://seekingalpha.com/article/4369319-elite-pharmaceuticals-inc-eltp-ceo-nasrat-hakim-on-q1-2021-results-earnings-call-transcript?page=3
ELTP$$$
Absolutely, YJ4LIFE.
Best CC in many years.
ELTP$$$
I see you on the Bid, Nasdaq2020. I know you are Buying more shares
ELTP$$$$$
Little more volume we have a run. Ask is crazy thin.
Purdue Pharma BANKRUPT.
Nice Comparison.
Just the facts for ELTP.
ELTP$$$$
$75 MILLION Tax credit. Best CC to date.
ELTP$$$$$$
Best CC to date in my opinion.
.071 x .0715
Bid is heavy and Ask is thin.
ELTP$$$
Per our understanding reading our CEO comments. Correct.
Nasrat stated this last quarter:
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.
https://seekingalpha.com/article/4356443-elite-pharmaceuticals-inc-eltp-ceo-nasrat-hakim-on-q4-2020-results-earnings-call-transcript?page=5
ELTP Should see $10,000,000 plus in revenue second quarter of fiscal year 2021 in my opinion.
Nasrat stated this last quarter:
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.
https://seekingalpha.com/article/4356443-elite-pharmaceuticals-inc-eltp-ceo-nasrat-hakim-on-q4-2020-results-earnings-call-transcript?page=5
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") (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://finance.yahoo.com/news/elite-pharmaceuticals-announces-commercial-launch-105400124.html
Everyone Is Talking About Elite Pharmaceuticals Inc (OTCBB:ELTP)
Elite Pharmaceuticals Inc (OTCBB:ELTP) has been moving up steadily in recent weeks attracting legions of shareholders who continue to bid it higher. There is plenty to get excited about on ELTP as the Company continues to grow and now boasts several FDA approved products and significant revenues.
The Company filed a PRE 14A on April 17 reporting a special meeting of shareholders will be held at the Residence Inn by Marriott located at 206 Route 303, Orangeburg, New York 10962 on June 23, 2020, at 10:30 a.m., local time for the following purposes: 1; To again vote on the prior amendment of our Articles of Incorporation to increase the number of shares of common stock the Company is authorized to issue from 995,000,000 shares to 1,445,000,000 shares and to file a new amendment to our Articles of Incorporation reflecting such approval; 2; To approve a proposal to grant discretionary authority to adjourn the Special Meeting, if necessary, to solicit additional proxies in the event that there are not sufficient votes at the time of the Special Meeting to approve Proposal 1; 3; To transact such other business as may properly come before the Special Meeting or any adjournments or postponement thereof.
Elite Pharmaceuticals Inc (OTCBB:ELTP) 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.
Elite’s principle product is SequestOx™, an immediate-release oxycodone with sequestered naltrexone abuse-deterrent opioid product for the management of moderate to severe acute pain. Additional products include bariatric, cardiovascular, antihistamine, skeletal muscle relaxants, antipsychotic, tricyclic antidepressant, along with a number of approved products pending manufacturing site transfer.
Elite’s lead 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 specializes in oral sustained and controlled release drug products with high barriers to entry. Elite owns generic which have been licensed to TAGI Pharma, Epic Pharma, Dr. Reddy’s Laboratories and Glenmark Pharmaceuticals Inc., USA. Elite currently has eight commercial products currently being sold, six products filed with the FDA, additional approved products pending manufacturing site transfer and the NDA filing for SequestOx™.
ELTP revenues are impressive – On February 10 ELTP reported results for the third quarter of fiscal year 2020 ended December 31, 2019. Consolidated revenues for the Third Quarter were $5.1 million, an increase of approximately 88% as compared to revenues for the comparable quarter of the prior fiscal year. The increase in revenues was largely attributed to revenues from the two products launched during the 2020 Fiscal Year, generic immediate release Adderall® and Dantrolene Capsules as well as strong growth in revenues relating to the sales of Isradipine capsules.
Microcapdaily has been covering Elite Pharma for years, we noted on November 14, 2014 – Elite Pharmaceuticals Inc (OTCBB:ELTP) made a highly explosive move up earlier this year off its base at a dime the stock saw highs over $0.90 per share on significant volume. Currently hovering over recently established $0.30 support ELTP continues to be one of the top traded stocks on the entire OTCBB: ELTP has been around for many years and used to trade on the Amex stock exchange where it once saw highs of $22 per share. The Company was delisted to the OTCBB in 2009 where it sat dormant for several years before the recent explosion in price and volume.
In December ELTP announced it received approval from the US Food and Drug Administration (FDA) for a 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 tablets. The product is a central nervous system stimulant and is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). According to IQVIA (formerly QuintilesIMS Health) data, the branded product and its equivalents had total U.S. sales of $1.3 billion for the twelve months ending October 2019. Generic Adderall XR is jointly owned and the second product approval for our Elite and SunGen Pharma LLC collaboration. Elite will manufacture and package the product on a cost-plus basis. Lannett Company, Inc. will be the exclusive U.S. distributor.
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.
Currently trading at a $74 million market valuation ELTP does have $1.8 million in the treasury, $24 million in assets and $7.7 million in current liabilities. ELTP is an exciting story in small caps with a number of FDA approved drugs already on the market reporting significant sales – ELTP reported $13,049,340 in revenues for the 9 months ended December 31, 2019 up from $6.2 million for the same period in 2018
https://microcapdaily.com/everyone-is-talking-about-elite-pharmaceuticals-inc-otcbbeltp/125712/
ELTP revenues are impressive – On February 10 ELTP reported results for the third quarter of fiscal year 2020 ended December 31, 2019. Consolidated revenues for the Third Quarter were $5.1 million, an increase of approximately 88% as compared to revenues for the comparable quarter of the prior fiscal year. The increase in revenues was largely attributed to revenues from the two products launched during the 2020 Fiscal Year, generic immediate release Adderall® and Dantrolene Capsules as well as strong growth in revenues relating to the sales of Isradipine capsules.
In December ELTP announced it received approval from the US Food and Drug Administration (FDA) for a 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 tablets. The product is a central nervous system stimulant and is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). According to IQVIA (formerly QuintilesIMS Health) data, the branded product and its equivalents had total U.S. sales of $1.3 billion for the twelve months ending October 2019. Generic Adderall XR is jointly owned and the second product approval for our Elite and SunGen Pharma LLC collaboration. Elite will manufacture and package the product on a cost-plus basis. Lannett Company, Inc. will be the exclusive U.S. distributor.
https://microcapdaily.com/everyone-is-talking-about-elite-pharmaceuticals-inc-otcbbeltp/125712/
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.
Currently trading at a $74 million market valuation ELTP does have $1.8 million in the treasury, $24 million in assets and $7.7 million in current liabilities. ELTP is an exciting story in small caps with a number of FDA approved drugs already on the market reporting significant sales – ELTP reported $13,049,340 in revenues for the 9 months ended December 31, 2019 up from $6.2 million for the same period in 2018.
https://microcapdaily.com/everyone-is-talking-about-elite-pharmaceuticals-inc-otcbbeltp/125712/
NORTHVALE, NJ / ACCESSWIRE / June 29, 2020 / Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (ELTP), a specialty pharmaceutical company developing niche generic products, announced results for the fiscal year ended March 31, 2020 ("Fiscal 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.
https://finance.yahoo.com/news/elite-pharmaceuticals-inc-reports-financial-225500663.html
August 14, 2020 (ACCESSWIRE via COMTEX) -- Financials for First Quarter of Fiscal Year 2021 ended June 30, 2020 will be released August 14, 2020
NORTHVALE, NJ / ACCESSWIRE / August 14, 2020 / Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCQB:ELTP), a specialty pharmaceutical company developing and manufacturing niche generic products, announced results for the first quarter of fiscal year 2021 ended June 30, 2020 ("First Quarter").
Consolidated revenues for the First Quarter were $7.5 million, an increase of approximately 124% as compared to revenues for the comparable quarter of the prior fiscal year. The increase in revenues was largely attributed to revenues from generic extended release Adderall® which was launched during the First Quarter as well as increased sales of generic immediate release Adderall®, Isradipine and Phentermine during the First Quarter as compared to the comparable period for the prior fiscal year.
https://www.marketwatch.com/press-release/elite-pharmaceuticals-inc-reports-financial-results-for-the-first-quarter-of-fiscal-year-2021-ended-june-30-2020-and-provides-conference-call-information-2020-08-14?tesla=y
Elite Pharmaceuticals, Inc. Reports Financial Results For The First Quarter Of Fiscal Year 2021 Ended June 30, 2020 And Provides Conference Call Information
NORTHVALE, NJ / ACCESSWIRE / August 14, 2020 / Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCQB:ELTP), a specialty pharmaceutical company developing and manufacturing niche generic products, announced results for the first quarter of fiscal year 2021 ended June 30, 2020 ("First Quarter").
Consolidated revenues for the First Quarter were $7.5 million, an increase of approximately 124% as compared to revenues for the comparable quarter of the prior fiscal year. The increase in revenues was largely attributed to revenues from generic extended release Adderall® which was launched during the First Quarter as well as increased sales of generic immediate release Adderall®, Isradipine and Phentermine during the First Quarter as compared to the comparable period for the prior fiscal year.
Elite Pharmaceuticals, Inc. to Host Conference Call to Provide Corporate Update and Discuss First Quarter of Fiscal Year 2021 Results on August 17, 2020
Published: Aug 12, 2020
NORTHVALE, NJ / ACCESSWIRE / August 12, 2020 / Elite Pharmaceuticals, Inc., ("Elite" or the "Company") (OTCQB:ELTP), a specialty pharmaceutical company developing niche generic products, announced today that it will release its 2021 first quarter financial results on Friday, August 14, 2020. Elite's management will host a live conference call Monday, August 17 at 11:30 AM EDT to discuss the company's financial and operating results and provide a general business update. Stockholders may submit questions to the company prior to the call.
Conference Call Information
Date:
August 17, 2020
Time:
11:30 AM EDT
Dial- in numbers:
1-800-346-7359 (domestic)
1-973-528-0008 (international)
Conference number:
98840
Questions:
dianne@elitepharma.com by 7:00 PM EDT on Saturday, February 15, 2019
Audio Replay:
https://elite.irpass.com/events_presentations
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company which develops niche generic products. Elite specializes in developing and manufacturing oral, controlled-release drug products. Elite owns multiple generic products which have been licensed to TAGI Pharma, Glenmark Pharmaceuticals, Inc., USA, and Lannett Company, Inc. Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.
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
SOURCE: Elite Pharmaceuticals, Inc.
9,19,18
Good luck Everyone!
Anyone see a revenue pattern?
ELTP revenues are impressive – On February 10 ELTP reported results for the third quarter of fiscal year 2020 ended December 31, 2019. Consolidated revenues for the Third Quarter were $5.1 million, an increase of approximately 88% as compared to revenues for the comparable quarter of the prior fiscal year. The increase in revenues was largely attributed to revenues from the two products launched during the 2020 Fiscal Year, generic immediate release Adderall® and Dantrolene Capsules as well as strong growth in revenues relating to the sales of Isradipine capsules.
In December ELTP announced it received approval from the US Food and Drug Administration (FDA) for a 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 tablets. The product is a central nervous system stimulant and is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). According to IQVIA (formerly QuintilesIMS Health) data, the branded product and its equivalents had total U.S. sales of $1.3 billion for the twelve months ending October 2019. Generic Adderall XR is jointly owned and the second product approval for our Elite and SunGen Pharma LLC collaboration. Elite will manufacture and package the product on a cost-plus basis. Lannett Company, Inc. will be the exclusive U.S. distributor.
https://microcapdaily.com/everyone-is-talking-about-elite-pharmaceuticals-inc-otcbbeltp/125712/
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.
Currently trading at a $74 million market valuation ELTP does have $1.8 million in the treasury, $24 million in assets and $7.7 million in current liabilities. ELTP is an exciting story in small caps with a number of FDA approved drugs already on the market reporting significant sales – ELTP reported $13,049,340 in revenues for the 9 months ended December 31, 2019 up from $6.2 million for the same period in 2018.
https://microcapdaily.com/everyone-is-talking-about-elite-pharmaceuticals-inc-otcbbeltp/125712/
NORTHVALE, NJ / ACCESSWIRE / June 29, 2020 / Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (ELTP), a specialty pharmaceutical company developing niche generic products, announced results for the fiscal year ended March 31, 2020 ("Fiscal 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.
https://finance.yahoo.com/news/elite-pharmaceuticals-inc-reports-financial-225500663.html
August 14, 2020 (ACCESSWIRE via COMTEX) -- Financials for First Quarter of Fiscal Year 2021 ended June 30, 2020 will be released August 14, 2020
NORTHVALE, NJ / ACCESSWIRE / August 14, 2020 / Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCQB:ELTP), a specialty pharmaceutical company developing and manufacturing niche generic products, announced results for the first quarter of fiscal year 2021 ended June 30, 2020 ("First Quarter").
Consolidated revenues for the First Quarter were $7.5 million, an increase of approximately 124% as compared to revenues for the comparable quarter of the prior fiscal year. The increase in revenues was largely attributed to revenues from generic extended release Adderall® which was launched during the First Quarter as well as increased sales of generic immediate release Adderall®, Isradipine and Phentermine during the First Quarter as compared to the comparable period for the prior fiscal year.
https://www.marketwatch.com/press-release/elite-pharmaceuticals-inc-reports-financial-results-for-the-first-quarter-of-fiscal-year-2021-ended-june-30-2020-and-provides-conference-call-information-2020-08-14?tesla=y
Top 25 Psychiatric Medications for 2018
Psychiatric medications are an important part of treatment for many people with mental disorders, such as depression, bipolar disorder, ADHD, schizophrenia, anxiety, and others. They play an important role in helping to alleviate the most serious symptoms, allowing people to better focus on their lives and on other treatment types, such as psychotherapy. Psychiatric medications are an important part of many people’s treatment plans for obtaining the most effective treatment for a mental health concern or mental illness.
It’s good to know what drugs are being prescribed most often for mental disorders in the U.S. These are the top 25 psychiatric medications by number of U.S. prescriptions dispensed in 2018, according to IQVIA, a global information and technology services company.
Maintaining its lead since we last did this review in 2016, Zoloft — a common, older selective serotonin reuptake inhibitor (SSRI) prescribed to help alleviate the symptoms of depression — remains the most prescribed psychiatric medication in the United States. Zoloft was prescribed nearly 49 million times in 2018, at a cost of $179 million. This makes it an affordable and easy-to-tolerate antidepressant choice.
It continues to be outprescribed over other antidepressants, as well as Xanax, a commonly-prescribed anti-anxiety medication found in our number two spot. Lexapro — another antidepressant used to treat clinical depression — holds on to its number three spot, with nearly 38 million prescriptions in 2018.
By far, the most common mental disorder that psychiatric medications are prescribed for is clinical depression. Although it is not the most prevalent mental disorder, it appears to the one that most psychiatric prescriptions are written for.
In 2016, more than 338 million prescriptions were written for anti-depressant medications. In 2018 that number decreased to 318 million — suggesting a slight decline in prescriptions for antidepressants.
A total of 611,780,251 prescriptions were made for psychiatric medications in the U.S. in 2018, at a cost of over $29 billion. That’s up only 2.42% from 2016, when 597,326,489 psychiatric prescriptions were made.
The most expensive medications on the list that make the most money for their manufacturers are:
Vyvanse (for ADHD) – $3.594 billion
Concerta (for ADHD) – $2.176 billion
Adderall (for ADHD) – $1.914 billion
Abilify (for bipolar disorder, depression and schizophrenia) – $1.704 billion
Wellbutrin (for depression) – $1.024 billion
Home » Blog » Top 25 Psychiatric Medications for 2018
Top 25 Psychiatric Medications for 2018
Top 25 Psychiatric Medications for 2018
By John M. Grohol, Psy.D.
Founder Last updated: 15 Dec 2019
~ 3 MIN READ
Psychiatric medications are an important part of treatment for many people with mental disorders, such as depression, bipolar disorder, ADHD, schizophrenia, anxiety, and others. They play an important role in helping to alleviate the most serious symptoms, allowing people to better focus on their lives and on other treatment types, such as psychotherapy. Psychiatric medications are an important part of many people’s treatment plans for obtaining the most effective treatment for a mental health concern or mental illness.
It’s good to know what drugs are being prescribed most often for mental disorders in the U.S. These are the top 25 psychiatric medications by number of U.S. prescriptions dispensed in 2018, according to IQVIA, a global information and technology services company.
Maintaining its lead since we last did this review in 2016, Zoloft — a common, older selective serotonin reuptake inhibitor (SSRI) prescribed to help alleviate the symptoms of depression — remains the most prescribed psychiatric medication in the United States. Zoloft was prescribed nearly 49 million times in 2018, at a cost of $179 million. This makes it an affordable and easy-to-tolerate antidepressant choice.
It continues to be outprescribed over other antidepressants, as well as Xanax, a commonly-prescribed anti-anxiety medication found in our number two spot. Lexapro — another antidepressant used to treat clinical depression — holds on to its number three spot, with nearly 38 million prescriptions in 2018.
By far, the most common mental disorder that psychiatric medications are prescribed for is clinical depression. Although it is not the most prevalent mental disorder, it appears to the one that most psychiatric prescriptions are written for.
In 2016, more than 338 million prescriptions were written for anti-depressant medications. In 2018 that number decreased to 318 million — suggesting a slight decline in prescriptions for antidepressants.
A total of 611,780,251 prescriptions were made for psychiatric medications in the U.S. in 2018, at a cost of over $29 billion. That’s up only 2.42% from 2016, when 597,326,489 psychiatric prescriptions were made.
The most expensive medications on the list that make the most money for their manufacturers are:
Vyvanse (for ADHD) – $3.594 billion
Concerta (for ADHD) – $2.176 billion
Adderall (for ADHD) – $1.914 billion
Abilify (for bipolar disorder, depression and schizophrenia) – $1.704 billion
Wellbutrin (for depression) – $1.024 billion
It’s no wonder that so many people believe we are over-medicating kids and teenagers who might suffer from attention deficit hyperactivity disorder (ADHD) — they make up three of the top five profitable medications in this list. In short, ADHD make up the cost of over a third of the prescriptions in 2018. Only antipsychotic medications — prescribed for various disorders including schizophrenia and bipolar disorder — cost more as a category.
Most Prescribed Psychiatric Drugs for 2018
Zoloft (sertaline) – Depression (48,999,022 prescriptions – $179 million)
Xanax (alprazolam) – Anxiety (39,916,469 prescriptions – $105 million)
Lexapro (escitalopram) – Depression (37,927,061 prescriptions – $174 million)
Desyrel (trazodone) – Anxiety, Depression (34,665,828 prescriptions – $115 million)
Wellbutrin (bupropion) – Depression (34,472,232 prescriptions – $1.024 billion)
Adderall (dextroamphetamine and amphetamine) – ADHD (33,807,381 prescriptions – $1.914 billion)
Prozac (fluoxetine) – Depression (31,190,127 prescriptions – $294 million)
Celexa (citalopram) – Depression (28,011,615 prescriptions – $46 million)
Cymbalta (duloxetine) – Depression (26,032,770 prescriptions – $378 million)
Ativan (lorazepam) – Anxiety (23,833,390 prescriptions – $137 million)
Effexor (venlafaxine) – Depression (21,717,245 prescriptions – $414 million)
Seroquel (quetiapine) – Bipolar disorder, Depression (20,844,624 prescriptions – $273 million)
Lamictal (lamotrigine) – Bipolar disorder (15,434,708 prescriptions – $731 million)
Concerta (methylphenidate) – ADHD (15,104,867 prescriptions – $2.176 billion)
Kapvay (clonidine) – ADHD (15,058,561 prescriptions – $171 million)
Remeron (mirtazapine) – Depression (13,539,039 prescriptions – $89 million)
Paxil (paroxetine) – Depression (12,874,006 prescriptions – $123 million)
Elavil (amitriptyline) – Depression (12,843,459 prescriptions – $96 million)
Vyvanse (lisdexamfetamine) – ADHD (11,569,232 prescriptions – $3.594 billion)
Depakote (divalproex) – Bipolar disorder (11,263,321 prescriptions – $363 million)
Abilify (aripiprazole) – Bipolar disorder, Depression, Schizophrenia (10,680,324 prescriptions – $1.704 billion)
Risperdal (risperidone) – Bipolar disorder, Schizophrenia (10,416,641 prescriptions – $485 million)
Zyprexa (olanzapine) – Bipolar disorder, Schizophrenia (7,192,047 prescriptions – $126 million)
Intuiv (guanfacine) – ADHD (5,696,366 prescriptions – $70 million)
Trileptal (oxcarbazepine) – Bipolar disorder (4,548,937 prescriptions – $322 million)
Psychiatric medications should only be prescribed by your treating psychiatrist or physician. The most effective treatment for most mental disorders is rarely medication alone. A combined treatment approach, that includes psychotherapy, results in quicker, more positive outcomes for most people who are coping with mental illness.
I know that many people take a medication alone. Or they take a medication prescribed by their family doctor, having never seen a mental health professional such as a psychologist or psychiatrist. If you’ve had a long-term disorder you’re living with, this may be just fine.
But if you’re a newly diagnosed individual with a mental disorder, you really should reach out to a psychiatrist or psychologist to confirm your diagnosis, and consider additional treatment options. There are a wealth of self-care strategies that a therapist can help you with as well. Many people find online support groups helpful, too. The important thing is to receive the best possible and most comprehensive treatment you can.
We last wrote about the the top psychiatric prescription drugs in 2016, and previously in 2013.
We would like to thank the good folks at IQVIA for providing the data.
https://psychcentral.com/blog/top-25-psychiatric-medications-for-2018
ELTP$$$$
POST-OPERATIVE PAIN THERAPEUTICS PIPELINE REVIEW AND DEVELOPMENTS.
Post-operative pain therapeutics currently exhibits a proliferating pipeline with 10+ therapeutic candidates.
Post-operative pain is a very common problem experienced by patients who undergo surgical procedures. Pain is an unpleasant sensory and emotional experience caused by any injury, disease, or surgical procedure. Pain can be acute or chronic, depending upon the time it lasts. Acute pain is an unpleasant sensory, and emotional and mental sensation, which usually lasts for several hours to days, rarely more than a month. Postoperative pain is a typical example of acute pain. Whereas, chronic pain usually lasts longer than six months.
According to the research findings, majority of the pipeline drug candidates are being developed to be administered by oral route. It has been observed that the oral route of medication is convenient, available in delayed or rapid release formulation, less risk of systemic infections, and inexpensive in nature, and also provides improved patient’s compliance. Administration of therapeutics for post-operative pain through oral route has shown promising results in clinical studies.
Elite Pharmaceuticals Inc., Epic Pharma LLC, Akorn Inc., Heron Therapeutics Inc., DURECT Corporation, and Cara Therapeutics Inc. are some of the major players involved in the development of therapeutics for the treatment of post-operative pain.
https://primefeed.in/covid-19-industry-impact/4375571/post-operative-pain-therapeutics-pipeline-review-and-developments/
Elite Pharmaceuticals, Inc. Reports Financial Results For The First Quarter Of Fiscal Year 2021 Ended June 30, 2020 And Provides Conference Call Information
August 14, 2020 (ACCESSWIRE via COMTEX) -- Financials for First Quarter of Fiscal Year 2021 ended June 30, 2020 will be released August 14, 2020
NORTHVALE, NJ / ACCESSWIRE / August 14, 2020 / Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCQB:ELTP), a specialty pharmaceutical company developing and manufacturing niche generic products, announced results for the first quarter of fiscal year 2021 ended June 30, 2020 ("First Quarter").
Consolidated revenues for the First Quarter were $7.5 million, an increase of approximately 124% as compared to revenues for the comparable quarter of the prior fiscal year. The increase in revenues was largely attributed to revenues from generic extended release Adderall® which was launched during the First Quarter as well as increased sales of generic immediate release Adderall®, Isradipine and Phentermine during the First Quarter as compared to the comparable period for the prior fiscal year.
Conference Call Information
Elite's management will host a conference call to discuss the first quarter financial results for fiscal year 2021 ended June 30th and provide an update on recent business developments. Stockholder questions should be submitted to the company in advance of the call.
DATE:
AUGUST 17, 2020
Time:
11:30 AM EDT
Dial- in numbers:
1-800-346-7359 (domestic)
1-973-528-0008 (international)
Conference number:
98840
Questions:
dianne@elitepharma.com by 7:00 PM EDT on Saturday, February 15, 2020
Audio Replay:
https://elite.irpass.com/events_presentations
The financial statements can be viewed for Elite's Fiscal Year 2021 First Quarter Report on Form 10-Q here.
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company which develops niche generic products. Elite specializes in developing and manufacturing oral, controlled-release drug products. Elite owns multiple generic products which have been licensed to Lannett Company, Glenmark Pharmaceuticals, Inc. and TAGI Pharma. Elite operates a cGMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.
40% Additional revenue. $10,500,00.
Blind estimation at the moment.
ELTP$$$$
OK, Best post of today. Seems to be a trend.
Chasing: PROVING
ELTP$$$$
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.
Regarding amphetamine ER capsules, the product was approved last December. We successfully launched it by March. Lannett, our sales and marketing partner has done a very good job with this product and we expect this product to continue to grow and contribute to our profit and revenues. Amphetamine ER is also marketed by Lannett and they have done an excellent job considering that this product has 11 players, most of which are very big pharma companies. They obtained enough shares for us to enjoy the revenues that Carter just cited a few minutes ago.
Loxapine, the transfer of Loxapine capsules and several of you had questions about that. Our facility was approved last quarter and we have a sales and marketing partner identified. The delay has been from the API supplier. As soon as we launched this product, we will let you know. We were hoping to launch it two three months ago, but as I said the API supplier had an issue and we are working with our partner and the API supplier to resolve that. This is a product that has an IMS data of $5 million. And there are four ANDAs approved including ours. Loxapine is on the FDA's product shortage list. The antibiotic tablets ANDA, this product was developed and filed with our partner SunGen. As per the agreement the ANDA will be in SunGen's name. We received a complete response letter with a minor designation. The work on the minor amendment was completed by Elite a while back. SunGen has not filed the response with FDA. They plan to do so sometime in September or October.
I will discuss that further in a couple of minutes. On the development pipeline, Elite is working on the central nervous system product discussed previously. We continue to work on other differentiating genetics for our future growth, and we will update you on those development projects upon achieving key milestones. Covid-19 has impacted our business like they impacted everybody else in the industry. We created an employee protection plan where those who are what we call non-essential, non-essential means that they can perform their job from home, working from home. Lab personnel went on two shifts in order to create more space between personnel. And we require them to wear masks and clean the place regularly. Manufacturing, we have rules on having no more than two operators in the room with frequent air changes and gowning and masks in order to secure their safety. This is a serious issue that's affecting everybody in the industry. So far the impact has been minimal on us, but it's always in the back of my mind in case if we have resurgence or we have a second wave in the fall. That could be a serious issue not only to Elite and here but also to our API suppliers and others in the pharmaceutical industry.
We held a special shareholder meeting last week for the proposals for additional authorized shares passed by a large majority. The election results are provided in our June 24 filing on the shareholder meeting. Thank you all for voting and thanks for all those who voted for or against.
I will take a minute and address the SunGen products that I just cited. We have several products with SunGen. The two antibiotics, central nervous system and also amphetamine ER and IR. The SunGen is a good company and they have a solid R&D group. Today's landscape has had financial impact on SunGen and I have discussed that in previous meetings. We know what's happening in China. Long before Covid-19, the turf war, the issues that were having with the Chinese, the devaluing of the currency, people unable to get money out of the country. SunGen depends on financing from China. They have spent a lot of money on R&D with very little money coming in, as many stopped or slowed down and coming in they needed to rediscover themselves or come up with an exit strategy. That impacted us on the antibiotic drug that I just mentioned. And also on the central nervous system drug.
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.
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.
https://seekingalpha.com/article/4356443-elite-pharmaceuticals-inc-eltp-ceo-nasrat-hakim-on-q4-2020-results-earnings-call-transcript?page=5
True. Revenues will continue to grow. No worries.
ELTP$$$$
Interesting read for shareholders. Many suggest Elite is poised for buyout or merger.
Is this the end game for ELITE? Many in the know agree.
JMPO
The biggest pharma merger and acquisition deals of 2019
The pharmaceutical industry saw some notable mergers and acquisitions in 2019; this article lists the top 10 by transaction size
https://www.europeanpharmaceuticalreview.com/article/111051/the-biggest-pharma-merger-and-acquisition-deals-of-2019/