Elite Pharmaceuticals, Inc. (ELTP) CEO Nasrat Hakim on Q4 2019 Results - Earnings Call Transcript

Elite Pharmaceuticals, Inc. (OTCQB:ELTP) Q4 2019 Results Earnings Conference Call June 24, 2019 11:30 AM ET

Good morning, ladies and gentlemen and welcome to Elite Pharmaceuticals Conference Call. At this time, all lines have been placed on listen-only mode. Before management begins, the Company has the following statements.

This conference call 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 any other expectations that may have some correlation to the subject matter of this conference call.

Listeners are cautioned that such forward-looking statements involve risks and uncertainties including, without limitations, Elite's ability to obtain FDA approval of the transfers of the ANDAs or the timings of such approval processes, 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, the steps Elite may take as a result of the CRL, and the actions of the FDA require of Elite in order to obtain approval of the NDA. 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.

With that covered, it is now my pleasure to turn the floor over to your host, Mr. Nasrat Hakim, President and Chief Officer of Elite Pharmaceuticals. Sir, the floor is yours.

Thank you, Paul. Good morning, ladies and gentlemen, and welcome to Elite's earning call. Usually, I would have Carter go through financials first, then give you a corporate update. Today, I'm going to go first, Carter will follow and then we'll get back with couple of questions that you have already submitted to Dianne.

As you are aware, Elite filed a notification of late filing with the SEC a week or two ago. Even though it is not an unusual event, I am going to paraphrase what's listed in the K and given you an added perspective.

Delay in filing or requesting an extension is not an unusual event among publicly traded companies. In fact, we all have heard of instances where companies file Ks and issue restatements way after the fact. That is not the case at Elite. The delay was not related to our financials, which were ready for reporting in a timely fashion, but rather to another issue. Elite's SEC attorney was not pleased with the warnings used in the auditor's report on a specific issue. So he asked for an explanation.

The auditor stated that they used such wording because they did not have enough time to thoroughly audit the documents associated with that section. We filed the extension to provide the auditors with the requested documents and allow them enough time to audit them, to ensure that they issue an accurate assessment of Elite's financials.

Regardless of all of that, the auditors identified two issues of concern. One is the material weakness in internal controls and two, is going concern. Material weakness in internal controls means that we don’t have enough checks and balances on some of our transactions. We are governed by FDA rules and by DEA rules, which means that every piece of inventory must be accounted for. DEA and FDA order them.

What that means is that whenever we buy 100 kilos of a controlled substance the DEA wants to know where every single gram went. What went into manufacturing a product, what was put on stability, what went into waste, so there is a very nice audit trail as a part of being a regulated industry in the pharmaceutical industry that makes the auditors' life very easy. However, there are other transactions that are strictly financial such as payables and receivables and those need to be audited as well. We have the second-in-command to Carter's position that was our checks and balances on Carter and he left Elite a while back and we have not replaced him.

The second item is the going concern. Going concern means, and I am simplifying and paraphrasing, that we don't have enough money to operate at our current run rate for about a year or so. That is, our expenses are greater than our income which is common for an R&D company and that is a true statement. Our FDA facility fees of $1 million, ANDA GDUFA fees, API cost for product launches, working capital, and infrastructure costs coupled with our limited commercial products are the main reason we are where we are.

So how do we fix it? The remedy for our current situation is raising money short-term to cover our fixed cost, product launches, and working capital, and increasing revenues and sales long-term to eliminate having to be in this position again. We have been working on fixing this problem for few years now and we are I believe very close to solving it. Generating new ANDAs by ourselves and with our partners is one means to overcome this issue. Creating an infrastructure that will support our product line is another, teaming up with sales and marketing companies that have much wider reach than we do, such as Lannett and Glenmark is another. So let me start with that.

Sales and marketing and product launches we have in place today three companies that have the sales and marketing distribution for Elite, and that is Glenmark, TAGI and Lannett. Glenmark partnership was put in place last year and we now have four products with them; Methadone, Phendimetrazine, Trimipramine, and Isradipine. Methadone, our partners have achieved good sales to date. Phendimetrazine, they are holding a considerable share of the market and they have met their targets and we are hoping they will maintain it or modestly improve it. Trimipramine, they have just started recently and Isradipine, we are in the process of transitioning that from our old partner Epic to them.

Lannett, the Lannett partnership was signed in the first quarter of this year and we have three products with them; Amphetamine IR tablets, this product was launched last month and we expect significant sales to begin in the next quarter. This was a product co-developed with our partner SunGen. The second is an extended release central nervous system product. We have not yet disclosed it and we will do so once it is approved. This product is filed with the FDA and is under review. This is the second product co-developed with our partner SunGen.

Let me pause at this point and update you on the status of the central nervous system extended release product. We filed the ANDA last year. The GDUFA date was March 2019 and the patent expired in April of 2019. We planned to launch in May. In preparation for filing the ANDA we asked the FDA several questions to guide us on what we need to do and what we can waive considering that there are other people already that have patent approval for this product. We in writing, through a controlled correspondence, asked the FDA if we need to perform a test called alcohol dumping dose pumping test. They said no in writing. We filed the ANDA without this test that we go a waiver for.

During the prosecution of the application or the review by the FDA, they requested elaboration or explanations for a few things, this did not come up. They asked us among other things about an injection practice of the clinical site which is typically common question and had typically common answer. The CRO answered it, we answered it and submitted the answer on time to FDA.

If you'll recall, during this review period the government got shutdown. We were assured that ANDA reviews will not be handled by the government shutdown because we're paying for it. And according to FDA it was not. However, to our surprise on our GDUFA date, the FDA requested that we go back and do the alcohol dose pumping test that they waived and said that they did not have enough time to review the CRO response to the injections which were submitted on time.

Now our new GDUFA date is December 2019. Let me explain the ramification of this action. Instead of becoming a viable breakeven or profitable company we have to carry the infrastructure and its cost, API et cetera, for eight more months. This is why we are tightening our belt, letting go of some employees and we did not replace others which led us to the problem that we have with internal controls.

And that is also why we have going concern, because if that product was approved when it was supposed to be approved and we launched it in May, we wouldn’t have any questions from the auditors. Just by way of example I will state what we were planning on doing and now how things shifted, things are still looking up for Elite and there are quite a few things that we need to do to get ahead a little bit of delay or a lot of delay in here, can be dealt with under the right circumstances.

If you look at our earnings from last quarter, the quarter ending March 2019, we earned roughly about $1.3 million during that quarter. Our earnings for the quarter ending in June 2019, this current quarter I expect will be at least double that. The quarter ending in September 2019 will be just as good as this current quarter, that is twice as much as the quarter before and the quarter ending in December 2019 should be three times larger than the March quarter.

So we had already revenues lined up and sales lined up working with our partners, these are all projections that are coming from our partners that the coming quarter ending in June and the quarter after and quarter after, things were moving up. And if we added the central nervous system ER to them it definitely would have been a needle mover and it will be a game changer.

Now we have to live in our means, carry all of that working capital whereby we invested in API and infrastructure and our money is tied up, you cannot pay the employees and you cannot use for something else is really detrimental for a small company. So the going concern as well as the controls could have dissipated if things could go into, went in a certain way, if the government hadn’t shutdown, if the FDA actually told us ahead of time that yes we want you to do this test instead of saying no were waiving it and then changing their minds.

Again, this is not a conspiracy, they do this with everybody, except big companies can take it and we're a small company that need the money and we can't. This is nothing against the FDA. That's the standard practice. They do this all the time. However, in this case it is something that we relied on heavily because this would have been our biggest product and did not come through for us.

We hope that comes through in December, and the numbers I gave you are independent of that. We will do much better this quarter, much better the quarter after, and really well in Q4 of 2019. I am not going to predict Q1 2020 because the FDA approval of the ER I am talking about would make massive difference in the prediction I am about to make. If they approve it, we are on our way. That would be really we have succeeded at changing the company from focusing only on the ART and waiting for SequestOx and other anti-abuse to actually making a viable company out of other products and when the ART abuse-resistant opioids hit that will be the icing on the cake. Okay?

In order to raise money we have communicated with multiple banks and with Wall Street. Raising money through Wall Street is very expense. The cost is very high. It very dilutive to our shares, but if we have to do it to survive we will do it. Of all the options we have had on the table, and all that we have experienced and all the investors we met with, Lincoln Park Capital is the least expensive, least risky, least dilutive method for us to pursue.

In addition to all of that, that team, the Lincoln Park Capital team is first class and outstanding to deal with. This is why we need additional authorized sales and we have already stated that in the K and we will be discussing this further when we meet again in about seven weeks, in August 10 or so, we will discuss that more in depth.

So what I wanted to summarize for you before I continue with my presentation is, what the auditors said the reason that existed and what we are doing in order to make sure it does not happen again, again all of these factors are within our control. We can come up with plans and as things change we are nimble and modify ourselves to move with them in order for us to achieve our goal of becoming financially independent, having fundamentals and moving on.

Okay Dantrolene capsules, we have received approval for site transfer. We've signed a deal with Lannett assuming that's public and we will be launching that product very soon. This is a product that Epic had for five years, we got it back last October and between October and now we have done the site transfer, found a partner, signed a deal, made the launch quantities and we're moving forward in a couple of weeks.

TAGI is our oldest marketing partner and we have three products with them that they are selling right now, Naltrexone, Phentermine tablets and Phentermine capsules. They had hydromorphone and they stopped selling it because nobody is approaching controlled substances nowadays, opioids because of fear of the lawsuits that are going on by the states all across the country. So they are selling three products, Naltrexone, which is really used with methadone as anti-abuse. I mean even though we have not kicked in our ART technology, Naltrexone is an antidote abuse and it is used heavily and methadone is used in methadone clinics also to help people get off the opioid habit.

ANDA approval from filings, we have had several approvals, I'm not going to cite them all, including IR and methadone and Dantrolene and we are commercializing all of these products. On the opioid front, we have the Oxy APAP and Hydro APAP and now we have hydromorphone because they are opioids and because of the landscape and how people are reacting and states are reacting to opioids and the opioid crisis and the losses that are going on we have not secured the partner for these and frankly I'm not in a hurry to secure any partner because I don’t want to be a part of losses, I can't afford. Okay?

So it is disheartening to see that we've done all this hard work, created ANDAs, paid for GDUFAs and got approval and all of a sudden the landscape changed and now instead of thinking we are a part of an honorable system that provides pain relief to needing patients that the fear of lawsuits because somebody could abuse it hanging over our head. So even though these are products for the future, I'm sure we're going to find a way once the dust settles to get them to the market. For now we are not there yet.

The extended release CNS ANDA is under peer review and I just described to you exactly what happened and where we stand. We are hoping because they never had any questions and the delay was because they really didn't have time to look at it that it will be approved in December and they won't ask any more questions and that definitely will be a game changer for us.

The antibiotic tablet ANDA has been filed and we should get approval probably in Q4 of this year and APAP with codeine and Tylenol with codeine we filed it in November, so sometime in Q3 of this year we should hopefully get approval from FDA or at least a response. Okay?

I will quickly update you on SequestOx, nothing has changed since we did the TMX [ph] and proved that we can take our product with or without food, the FDA came back with additional characterization work for certain excipient [ph] and an assessment of the risk of abuse by intravenous route and repeating the clinical trial on a larger scale, that will cost a lot of money and for now we are focusing on survival, working capital, getting the products that we know are going to make us a viable company and hopefully once that happens and we start generating profits we'll start spending it on things like this, but for now that is definitely on hold.

Now having said that, we did ask the FDA for extension and they gave it to us and they waived the $2.6 million for year and a half from the day we requested it and all of that is good, but in the meantime, we're not spending any money on it right now for obvious reasons. We slowed down development again because that's costing us a lot of money and also because we have so many products we need to launch, so we need to change our focus.

Our facility is not that huge. We have two buildings, but with all of these products and the volumes that are coming, we definitely cannot afford to be running anything in here and so we're trying to be selective in order for us to make sure we satisfy our partners sales and marketing partners needs and become a profitable company.

Having said that, we still have few very viable and strong products that are in the works including one with function that's and extended release product that has an IMS data of over $1.5 billion that’s going to be as big as, if not, bigger than the central nervous system product that’s coming in December. Any product that is this big we’re putting all our resources on, the small little products we’re trying to shy away from. The work that we can do that doesn't cost much money we will do, but any filings and clinical trials and fees we are shying away from that.

Okay, so just to wrap up the first section before I turn this over to Carter, our growth is continuing, whether it is in generating new ANDAs, getting really solid sales and marketing groups, teams. In sales, we see the sales increasing as I stated this quarter, next quarter, and the quarter after. We see huge potential in December of getting an approval for the product that's pending with the FDA that could be a game changer for us, all of us as stockholders and investors and the employees. And based on all of this, we definitely expect increase in revenues in the future, and that is going to help us resolve the two issues that were identified by the auditors.

Mr. Ward, you have the floor.

Okay, thank you Nasrat, and thanks to everyone calling in today. Last Friday we filed our 10-K for the fiscal year ended March 31, 2019, we're on a March 31st fiscal year. So that's fiscal 2019 for us. The K is available on the investors sections of our website which is elitepharma.com as well as SEC.gov and the many other websites that provide links to our filings. So if you haven’t gone through the K yet, please get a copy from elitepharma.com or any of the other usual sites.

Let me start by discussing the two items that were in this K that were not in the last year's K. Nasrat gave a really good summary of them, but I’ll add just a little more. First is the identification of material weaknesses in internal controls. The last time we had identified such material weaknesses was the 2016 fiscal year. And the second item is the audit opinion including a going concern qualification. And the last time we had that, going concern opinion was the 2013 fiscal year, so both of these have happened before.

So let’s start with the internal controls, it’s a complex area. I recommended you give a careful read of item 9A in the K and that has a detailed discussion on controls and procedures. On this call, I’ll do my best to summarize and provide some background and context, although Nasrat did a really good job already.

Internal controls, what they are, they are systems and procedures which are designed and implemented to ensure the integrity of financial and accounting information. These controls document what they are, who performs them, and how they are evidenced. The controls are tested to demonstrate that they are not only designed correctly, but they are also operating effectively in the tests and the results of these tests are also documented.

Now for the prior two years 2017 and 2018 fiscal years, we had the personnel and resources both internal and external. We also use external consultants, for this. We had them in place and our controls were sufficiently documented, they were successfully tested. It took significant resources to do this, both financial and personnel wise, but there were no material weaknesses identified during those two years.

During this year however, fiscal 2019, we lost certain personnel specifically my senior accountant, my right hand man who performed controls and testing and were not replaced. In addition due to financial constraints we were not able to engage the external resources, the consultants that we had used and that were required to maintain the existing control environment.

So when that happens you need to do two things, first, you have to redesign your controls and update all of the related documentation to reflect the changes in the personnel and the resources and second, after you've done that, you have to test these controls to prove, to demonstrate that they’re working, the new controls are working. While we were not able to fully revise and document the new controls within the time period and document controls that are consistent with the existing personnel and resources, and there also wasn't enough time available to allow for adequate testing of any new controls anyway had they been implemented.

Remember you have to - time has to elapse for many of these controls to be tested. They have to have a chance to be performed in order to have something to test. So that's results in a - an identified material weakness in internal controls and that’s what happened. In addition, the various reconciliation reviews, checks and balances that were previously performed by others are now in some cases being done by me, the CFO and this results in an insufficient segregation of duties also a material weakness. This material weakness we had many years ago when our staff was much smaller as well and I did most of this work back then also.

I will note however, that while we have identified material weaknesses in our internal controls, our auditors have issued an unqualified opinion on the financial statements themselves. So what that means is that despite the existence of control weaknesses, our auditors have concluded based upon a thorough, and I would say very thorough audit, that the number themselves fairly present the financial statements.

But nevertheless this is still a weakness. There are risks associated with such weaknesses and they are noted in the risk factor section of the K, and even those risks don’t go away even if the numbers themselves get a clean opinion. So now to fix this we need to design new controls, which meet the criteria set forth in the COSO framework, that’s the standards we need to meet in order to have effective internal controls. We need to document the controls. We need to implement them and then we need to test them over an adequate period of time to demonstrate that they are operating effectively.

This was a big project for us when we first did it in 2016 and it remains a big task for us now. Additional personnel and significant resources are required, so the timing of successful remediation of these internal control weaknesses does have a strong correlation, a direct correlation to our financial position.

Now to the going concern opinion which Nasrat also explained quite well, there are disclosures in the K of our ability to operate as a going concern. I recommend a careful reading of Note 1 to the financials as well as the auditors opinion. And in this call I'll try my best to summarize, provide some context, a little more than what Nasrat gave as well. Going concern, that's an accounting term, it's relating to the company being able to operate for a certain period which is usually defined as one year beyond the date of the audit report.

Our K includes a disclosure of a substantial doubt of our ability to operating as a going concern and that’s due to operating losses on our statement of operations and the net outflow of cash on the cash flow statement. We have had going concern opinions from 2003 through 2013. From 2014 through 2018 however, due to additional investment, most notably from the sales of common stock through Lincoln Park we were able to successfully ensure adequate resources to operate as a going concern, and therefore we did not have this opinion in our financial statements for those years.

In 2019 however this year, even with the Lincoln Park equity line still in place the current stock price level does not enable us to forecast a sufficient level of sales of common stock to Lincoln Park in the coming 12 months to ensure our operations as a going concern. The fix for this is the primary focus of everyone at Elite. Nasrat gave a very detailed description of what we’re doing, but to really summarize, we need to do, increase our sales of existing products, bring in new products as we’ve gone over, additional investment and also reducing expenses.

So Nasrat gave an update on the products, the pipeline. As far as additional investment in our K there is an item 9B which gives information on the annual shareholder meeting and proxy which is related to efforts regarding additional investment and cost reductions have been implemented and they are continuously monitored. We’re really tightening our belts lately.

So, now to the financials, revenues for the 2019 fiscal year was $7.6 million as compared to $7.5 million for the prior year, essentially flat, it’s a $0.1 million increase pretty much flat on a year-to-year basis, but the product mix is different, a little different this year as compared to the prior year. Naltrexone was up over last year and that has been a very nice product for us from starting from the end of fiscal 2019 and continuing through today it’s doing very well.

We also launched our own generic Methadone products. That's being marketed through Glenmark, one of our alliance partners. That also happened towards the end of the fiscal year, so there is some contribution in the 2019 fiscal year and that's compared to no Methadone contribution in the prior year, in the 2018 fiscal year.

On the flip side, hydromorphone which was once a strong product for us in prior years is no longer being ordered or actively marketed by our marketing partner for this which is TAGI, has not as yet explained the main reason for this our market conditions, both the opioid litigation and also there are additional taxes which have been placed on opioids by the various states. Some of these taxes were even retroactive, which caused quite an expense for us and so there were no hydromorphone sales during the 2019 fiscal year.

Not reflected in the 2019 fiscal year are some of things that Nasrat just the mentioned. There we did not have revenues of the shipments of the immediate release generic Adderall product to Lannett, one of our alliance partners. The first shipment of these products went out in the first week of April 2019. So we just missed the March 31 cut off for this fiscal year, as well also not included is our first shipments of Isradipine and Trimipramine to Glenmark our other alliance partner and these also occurred just after the March 31 cut off. So these are things that just missed the cut off. They are not in the March 2019 fiscal year, but they are making a significant difference currently subsequent to the cutoff of the K.

The addition of Lannett and Glenmark as marketing alliance partners, during this year they represent the significant improvement in our market reach with the contribution from them being minimal joint fiscal 2019 just because of timing but now it is significant since March 31. So we’re optimistic, especially about our alliance with Lannett which was instituted in March 2019 and they are already exceeding expectations with generic Adderall, immediate release Adderall product and the launch of generic Dantrium which is Dantrolene Sodium which is expected in the very near future.

So to summarize our results of operations, number wise, there wasn't much variance from the prior year. There’s a slightly different mix of product contribution and the growing contribution from Lannett and Glenmark being minimal prior to March 31, and mostly occurring just after the March 31 cut off and continuing through today.

Now, we’ll move to the question and answer part of this call which will be led by our CEO, Mr. Nasrat Hakim.

Great, you all sent, no some of you sent Dianne a bunch of questions, she consolidated them as always and I have several papers in front of me, so I'll try to go through them as best as possible. And at first glance it seems like I've answered quite a few. Starting with the status of SequestOx I have already answered that and I went through the details of what we did and did not do with FDA.

Is Elite cheaper new IR ADF platform document that's shown to be used in NDA or ANDA that will be a generic product?

At least that's our request of FDA.

How far along are we with this product?

Well it's going to be an opioid, so we're slowing it down. We have not begun clinical trials because obviously we need to see what's going on with the landscape there and make sure that the losses are settled before we through our hat in the ring.

How robust of an ADF is the new IR ADF platform is oral, chewing abuse is that possible?

Adderall IR and Dantrolene, why did Elite not issue press releases upon the approval of Dantrolene?

This is a site transfer. You don’t always issue press releases for a site transfer. Okay? And for the Adderall IR any time we ship material to our sales and marketing partner, that's not a quiet launch for them because they receive all that material and then they launch at a different date. So it gets to be really messy and we don’t want to send out any accurate information. So what we usually do is that we announce during these meeting when the sales will start and update you on that.

Have any of the site transfer drugs launched yet?

Yes, Trimipramine launched and Dantrolene in the next couple of weeks and Isradipine definitely launched as well. The one pending is [indiscernible] and it is approved and filed with FDA and waiting for them to answer us.

Are there going to be any substantive changes to Elite's investor relations strategy? Zero announcements for the last three months.

Our stockholders are addicted to announcements. I have worked for a lot of companies that are on NASDAQ or Wall Street and they do not have as many conference calls and as many updates and announcements as we do. We are a penny stock [ph] company. We are not obligated to even have an earnings call, yet we take the time to update you guys every single time on earnings call, every single quarter four times a year, I personally go through the status of the company and update you on things that are pending whether they materialize or not, this is our vision that's what we're doing. That's what we are filing with the FDA. I do not think we can do beyond that. Okay? So you need to temper your expectation and whenever ask a question a little and understand for a penny stock company you are getting a lot.

Okay, what is the status of the CNS extended release?

I already went through that thoroughly, what's happened with FDA, when was the GDUFA date, and when is the new GDUFA date and I am hoping this really is going to be the product that puts us on the financial map if you will.

What is going on with Percocet and Norco generic?

As I have stated before, these are narcotics and many partners are really nervous about launching anything that has to do with narcotics right now.

Does Tylenol with codeine have similar concerns as the opioids?

To some extent. The good news for APAP with codeine or Tylenol with codeine is that it is a schedule 3, not a schedule 2 which makes it more palatable for doctors to prescribe it, a lot easier for them to do it and a lot easier for us to store it. And it is also less potent and it has not been the part of lawsuits yet. So once we get an approval, we'll see if anybody is brave enough to be our partner and or we have to wait until we resolve these issues.

What about the Isradipine Phase 3 trial?

We'll, you know what, I am very disappointed for the sake of the Parkinson's patients that it was not successful, regardless of whether Elite would have benefited or not. But now that the dust has settled I can tell you, even on the day the announcement came in Dianne was already coordinating for Chris and I to meet with the owners or the sponsors of the clinical trials and of the product and the news came in that it did not work. But we were actually willing to help even making the product even if we didn’t make any money because this would have been a wonderful thing for anybody with Parkinson's.

This was the last question and this ladies and gentlemen concludes our call for today. Thank you very much and we will talk to you in about seven weeks. Thank you, Paul.

Thank you. Ladies and gentlemen, this does conclude today's conference call. You may disconnect your phone lines at this time and have a wonderful day. Thank you for participation.

Source: Seekingalpha.com

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• Risk • Stock dilution • Lincoln Park • Dantrolene • Tagi (Ginti mayor) • Naltrexone • Phentermine • Tablet (pharmacy) • Phentermine • Capsule (pharmacy) • Hydromorphone • Controlled substance • Opioid • Fear • Naltrexone • Methadone • Substance abuse • Naltrexone • Antidote • Substance abuse • Methadone • Methadone • Opioid • Methadone • Dantrolene • Opioid • Paracetamol • Paracetamol • Hydromorphone • Opioid • Opioid • Opioid crisis • Central nervous system • Peer review • Antibiotics • Tablet (pharmacy) • Paracetamol • Co-codamol • Food and Drug Administration • Nothing Has Changed • TMX Group • Food • Food and Drug Administration • Excipient • PH • Risk • Intravenous therapy • Clinical trial • Money • Working capital • Company • Food and Drug Administration • Marketing • Profit (economics) • Company • Environmental economics • Product (business) • Instant messaging • Nissan Silvia • Central nervous system • Food and Drug Administration • Shareholder • Revenue • Audit • Fiscal year • Fiscal year • Website • U.S. Securities and Exchange Commission • Materiality (auditing) • Fiscal year • Auditor's report • Going concern • Going concern • Fiscal year • Information system • Integrity • Finance • Accounting • Information • Document • Test (assessment) • Test (assessment) • Employment • Natural resource • Finance • Finance • Human resources • Accounting • Finance • Theory of constraints • Time • Time • Time • Probability • Separation of powers • Chief financial officer • Separation of duties • Materiality (auditing) • Employment • Employment • Materiality (auditing) • Internal control • Audit • Financial statement • Audit • Audit • Financial statement • Risk factor • Committee of Sponsoring Organizations of the Treadway Commission • Time • Project management • Time • Internal control • Going concern • Going concern • Audit • Try My Best • Going concern • Accounting • Company • Auditor's report • Corporation • Going concern • Business operations • Cash flow statement • Going concern • Investment • Common stock • Lincoln Park • Factors of production • Going concern • Financial statement • Linkin Park • Stock • Stock • Price level • Common stock • Linkin Park • Going concern • Annual general meeting • Investment • Cost • Fiscal year • Naltrexone • National Institute for Health and Care Excellence • Methadone • Fiscal year • Fiscal year • Methadone • Hydromorphone • Marketing • Tagi (Ginti mayor) • Market (economics) • Opioid • Lawsuit • Tax • Opioid • Tax • Hydromorphone • Fiscal year • Fiscal year • Adderall • Fiscal year • Isradipine • Trimipramine • Fiscal year • Adderall • Adderall • Dantrolene • Dantrolene • Variance • Food and Drug Administration • New drug application • Abbreviated New Drug Application • Food and Drug Administration • Opioid • Clinical trial • Substance abuse • Adderall • Dantrolene • Dantrolene • Adderall • Marketing • Trimipramine • Dantrolene • Isradipine • Food and Drug Administration • Investor relations • NASDAQ • Wall Street • Penny stock • Penny stock • Central nervous system • Modified-release dosage (medicine) • Food and Drug Administration • Oxycodone/paracetamol • Hydrocodone/paracetamol • Generic drug • Narcotic • Narcotic • Co-codamol • Opioid • Paracetamol • Co-codamol • Controlled Substances Act • Isradipine • The Last Question • Conference call • The Wonderful Day (1932 film) •