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CASI Pharmaceuticals Inc (CASI -2.79%)
Q4 2019 Earnings Call
Mar 16, 2020, 4:30 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Welcome to the Year-End 2019 Financial Results and Business Update Conference Call for CASI Pharmaceuticals. [Operator Instructions] At the end of the prepared statements participants will have the opportunity to ask questions. [Operator Instructions].

Please note that the remarks today will include forward-looking statements and that actual results could differ materially from those projected or implied in our forward-looking statements. For a description of the -- of important factors that could cause actual results to differ, we refer you to the forward-looking statements in today's press release and note -- the note on the forward-looking statement in the company's SEC filings.

It is now my pleasure to turn the call over to CASI's Chairman and CEO, Dr. Wei-Wu He. Dr. He, please proceed.

Wei-Wu He -- Chairman and Chief Executive Officer

Well, thank you very much. This is really -- actually the first time that CASI has a [Phonetic] conference call. We think actually at this very unique moment in -- I really like to give everybody, our royal shareholders a -- kind of a real update of the company.

And I have to begin with the call by discussing the remarkable year we had in 2019. If everyone recall, CASI is actually a pretty old company, more than 20 years. But starting in August 2019 the company finally launched its first product EVOMELA in China. And -- which really sets CASI apart from many, many non-commercial biotech companies. And ever since we launched the drug in August, we actually recorded $4.1 million in revenue by end of the year. And this is actually a remarkable event. Myself has been investing in biotech for 20-some years. Personally, I think this is a really, really unique event. We finally have built a real pharmaceutical company with China as a major focus. As China has 1.4 billion people aging, we believe the pharmaceutical market in China is really, really just a very beginning of the growth.

And let me spend a little bit time on this unique drug EVOMELA. EVOMELA really is a pre-conditioning agent for autologous transplant for multiple myeloma. While melphalan is available in the US for many, many years, this is really the first melphalan ever commercially launched in China. And we actually -- and because it's a unique formulation and it's easy of use, we think this drug is really actually a very proprietary drug in China, and we still remain very bullish on this drug is going to become the melphalan of choice in China for many, many years to come.

The -- regarding the coronavirus, our commercial operation is impacted a little bit first part of this year. But we actually think this is going to be a very temporary slowdown of our commercial launch. Our first quarter revenue probably will be impacted by the virus, but because this drug is such an essential drug for people who has multiple myeloma, we believe this is a very temporary thing and it will -- our commercial team -- many of our commercial team has now resumed operation in China. And we think we will have a slight impact of revenue, maybe for the whole year, but in the long run, we basically do not believe this virus will have much impact on EVOMELA.

So, as a whole, I think, CASI is a -- not only we proved to people that, we know how to licensing drug, we now actually proved to people that we can actually commercialize a drug in China. And in China, the first -- a little bit over one quarter hitting $4.1 million revenue is not a small task. And we have done it, I'm actually really very proud of our commercial team under the leadership of Larry Zhang, who really did a phenomenal job. I have to say, we probably have one of the most professional Hemato-Oncology sales team and commercial team now in China. And with that team in place, we think CASI is really build to become a leading hematology/oncology cooperation in China.

So let me turn a little bit into the CAR-T 19. We all know that CAR-T 19 is a drug which really save people's lives, especially for B-ALL. Our drug was actually approved by Chinese authority to start clinical trial. And originally we were planning to dose the first patient at the very beginning of the year. But with the virus, we did have a little bit delay of the dosing of the first patient, but actually from today it looks like our program is fully on target to start dosing the patients and maybe even complete our Phase 1 trial within this year.

And regarding CD38, which is the -- we believe this is a best-in-class monoclonal antibodies for CD38 and we licensed this from Black Belt Therapeutics and we have the global right of CD38. We are actually on track to file an IND in UK and start Phase 1 clinical trials actually in 2020.

The company what I really like to stress to our current shareholder and for the royal shareholders is, I personally myself is a pretty big shareholder. We are -- personally I'm sort of like this company, we finally turned a 20-year old company into a very aggressive licensing company and launching proprietary medicines in a large market like China, and we were able to successfully launch our first drug and build a world-class commercial team and we are adding more activity into in-licensing activity, where CD19, which is we believe is going to be the first domestic -- China domestic CD19 clinical program in China. And CD38 coming along the pipeline, we're going to be actively looking for EVOMELA molecules. We have also have many other molecules like ZEVALIN, MARQIBO. Today we're not going to spend too much time on it, and I refer to the investor to our filing. We think we are on our way to build a very exciting hematology/oncology focused franchise in a very big market like China.

And with that said, I really like to use this opportunity to hear from our investors and answer some of your questions. So really thank you very much for all the shareholders, for the analysts that you have supported the company and we -- I really want to use this opportunity to answer some of the questions that -- from our shareholders. Let me turn on -- turn it to the Q&A.

Questions and Answers:

Operator

[Operator Instructions]

Wei-Wu He -- Chairman and Chief Executive Officer

Well, any questions? If there's no question, I'd really like to thank everybody for being a royal shareholder of the company. And -- oh, we do have question coming. Okay. Go for it.

Sean Lee -- HC Wainwright & Co. -- Analystg

Hello. Can you hear me?

Wei-Wu He -- Chairman and Chief Executive Officer

Yes. Now, I can. Yes.

Sean Lee -- HC Wainwright & Co. -- Analystg

Great. Hi, guys. This is Sean from H.C. Wainwright. Thanks for taking my questions. So I have a couple of questions on the -- what kind of impact we can expect from the coronavirus. I understand that you mentioned that many of the operational -- commercial team in China has already resumed operation. But have the hospitals resumed normal operations as well?

Wei-Wu He -- Chairman and Chief Executive Officer

Yeah. So Larry, you are probably much more closer to the commercial team. Do you want to answer this question? Larry is our President and he is really our hero of leading the commercial operation in China. And Larry joined us from Novartis about a little bit over years ago and he was the former CEO of Sandoz, China. Go for it, Larry.

Larry Zhang -- President

Hi. This is Larry. I will be happy -- yes, I will be happy to answer the question. Actually, yes, we did see the impact of coronavirus in China. And especially for the month of February we can see the continuity of the impact in this month as well. And this was because the majority of the hospitals, either they are closed and therefore the surgery for the patients with the multiple myeloma, all is because lack of the physicians and the nurses or staffs in the hospital, especially for the major hospitals like the hospital in Beijing, Shanghai and Guangzhou. Another reason is because it's a significantly lack of blood which is a fundamental supply element for surgery. That has been the cause of the business went down and the total number of subsidiaries are down in China. But now we can see that there is a good change and it is a great journey and the reason the business is back to the normal. We feel OK for some time, but our medical reps can't go to the hospital, the majority of hospitals, especially in the South of China. And the North China have taken relatively slow pace right now, but more and more hospitals are opened now. So that is where we are and we can say probably in April, almost [Indecipherable] normal, that's the situation right now.

Sean Lee -- HC Wainwright & Co. -- Analystg

Great. Thanks for the additional color on that. I was also wondering are you seeing any impact on the supply side because of the virus. Is it spreading to the US and Europe as well.

Wei-Wu He -- Chairman and Chief Executive Officer

Larry, you want to take that [Speech Overlap] We did stock up -- we did a stock up quite a big inventory, so we do not see -- I personally don't see any short-term impact. Because this is a drug that -- if we manufacture one batch it will last quite a while. So Larry, would you want to add some more color on to that?

Larry Zhang -- President

This is correct. Currently, we don't have any concern for out of stock. And supply chains are going quite well. And we have [Indecipherable] warehouse. And so that's where we are right now.

Sean Lee -- HC Wainwright & Co. -- Analystg

Thank you. That's great to hear. And finally in terms of your balance sheet --

Wei-Wu He -- Chairman and Chief Executive Officer

Sorry. By the way -- sorry. By the way. I'm sorry, go ahead.

Sean Lee -- HC Wainwright & Co. -- Analystg

I'm sorry. Go ahead.

Wei-Wu He -- Chairman and Chief Executive Officer

Just on the -- one more information I want to add since EVOMELA is live and a substantial medicine. So it's for the supply and this is not in the big volume and we need to ship to the hospital. So if hospital and until now it's for the major hospitals and as their supply isn't enough and for a couple of months. So that is where we are.

Sean Lee -- HC Wainwright & Co. -- Analystg

That's really good to hear. Finally, it's on your balance sheet. What's your cash position right now? And how long do you expect your run rate to be?

Larry Zhang -- President

We have over $50 million cash in the bank and our burn rate is relatively low, something around $30 million. And so we have enough -- we have enough money to -- for the year. And I'll probably add a little bit color to that. The last two deal we did, one is CD19. Most people don't realize that, actually about $10 million was dished-out, it's actually equity investment, not from payment. We're pretty frugal when we license drug, because we think a lot of Chinese company is really over paying for some of the assets. We are pretty careful. And even the CD38 licensing, a big -- a part of our payment is equity payment into Black Belt.

So although these more than $10 million was dished out, but it's really equity in these companies. I hope that answers your question.

Sean Lee -- HC Wainwright & Co. -- Analystg

Yes, Just with all the market volatility, it's very reassuring to hear that you have a long way on the cash. Good. That's all I have. Thanks again for taking my questions.

Wei-Wu He -- Chairman and Chief Executive Officer

Yeah. Thank you so much.

Operator

[Operator Instructions] We have a question from Nathaniel Calloway. Nathaniel, your line is open.

Nathaniel Calloway -- Edison Group -- Analyst

Hi, guys. I was just interested to see if you can give us an update on the progress in facility at Wuxi. I heard that you had to break ground on it before August of this year? If I'm wrong, correct me. Just wondering if anything has happened with that? And if there's any sort of updates with that? And the ANDA portfolio in general. Anything to talk will be great.

Wei-Wu He -- Chairman and Chief Executive Officer

No. That's great. Yeah. So we basically -- we licensed a quite a few ANDA and -- because some of the medicine that we licensed in -- although it's generic in the US, but some of them are not. As a matter of fact, our first drug EVOMELA, melphalan is generic in the US, but it's the only -- our EVOMELA, which is really a reflated melphalan. It's the only game in China, so we actually -- one of the plan we are doing is actually ultimately planning to manufacture some drugs like this. I don't want to be too specific, because there is a lot of confidential stuff. But one of the -- we didn't slow down our manufacturing site a little bit because China chanced it's new policy of so called 4 plus 7 and a lot of the -- like lot of the drug we licensed in, the margin no longer is there. So we're putting a break on some of those drug launches. So we're really right now overly emphasize on proprietary hematology/oncology franchise.

So some of the manufacturing facilities are kind of geared toward making -- building the plan for that plant. So one of the -- one of the -- the plan is, we probably will have to build a large cell therapy facility for our CAR-T 19. So those are all in -- planning in progress. And we will update shareholders on those progress, but the route of the Wuxi facility -- we got a lot of support from the Wuxi local government. The land we actually purchased is really a great deal. And it's really actually very hard to find this plot of land in China, close to Shanghai. So we actually got this piece of land -- this piece of land is very close to the subway and you can get on the subway, hop onto the high speed train to Shanghai within an hour. It's really, it's -- the site we acquired really is, I think, the crown jewel of the piece of property near Shanghai. If today you ask me, can I get another piece of land like this, I'll probably say no. We probably already missed the opportunity.

So I think for CASI shareholder, we are really planning for long-term, because I can imagine we become the largest hematology/oncology pharmaceutical company in China in the future, and we don't have our own manufacturing site. So we are actually really acquiring this manufacturing site, preparing for the next 10, 20 years. So I don't know if that answers your question. But we will be very selective where we will be putting the money. Does that answer your question.

Nathaniel Calloway -- Edison Group -- Analyst

Yes, thank you. Thank you for that. It's very helpful. I have another question, just briefly, it's a bit of bookkeeping, but in the past two filings you briefly mentioned Thiotepa, which you acquired [Indecipherable], but you haven't really said very much about that deal or that drug anywhere else? And I was wondering if maybe you could comment a little bit on Thiotepa, where you got it and are you planning on doing with it?

Wei-Wu He -- Chairman and Chief Executive Officer

Yeah. So we actually for reasons we probably cannot disclose. So yet it's -- it's the -- the Licensor --the company license the drug to us, they would like to keep this a low profile. But I want to use this opportunity to share with investors that by building a great commercial team in hematology/oncology, especially in the transplant market we got to know all the key opinion leader in China. As a matter of fact, this drug was actually introduced to us through a key opinion leader in China. He is the number one physician in autologous transplant. This German company actually wants to launch this drug in China, and they contacted the opinion leader. And the key opinion leader basis, they -- I know one company really knows how to launch a drug in China that's CASI. And because of that, we licensed this drug with very little upfront payment and we believe with melphalan and with this drug we probably will be the number one hematology transplant company in China.

So for reasons we probably cannot discuss too much. We are being kind of bounded by the company licensed to us, that we did not do press release, but we did do the fillings. And give us a little bit time, we will probably be -- but it's a -- it's a wonderful drug, it's again another drug that has been used by Western countries for many, many years, but it's absolutely not available in China. And we think that by the time this drug gets approved our commercial team should have completed the commercial work for melphalan and so they will then have another drug to commercialize pretty soon.

Nathaniel Calloway -- Edison Group -- Analyst

Okay, thank you. That's really helpful. And just along the same lines, my last question is, just if you can give us some guidance on how you're thinking about future licensing and acquisitions. If you're --because in 2019, it seems that you shifted a little bit away from the original strategy of in-licensing assets that will mature outside of China and they are using some of the new reforms, regulatory reforms in trying to get those drugs up into the market quickly. In 2019, we saw you in-licensing a lot more early stage drugs. And I want to just get an idea of how you're thinking about that going forward? Which are those sorts of things we're going to be able to see.

Wei-Wu He -- Chairman and Chief Executive Officer

Yeah. I think, overall, we basically are playing the long-term arbitrage opportunity between Chinese pharmaceutical market, which is serving 1.4 billion people, agent. We think this arbitrage opportunity will be going on for the next 20, 30 years. So -- but we need to pick out battle. So right now, the key battle we're picking is hematology/oncology. So we are looking at a lot of compounds and assets that is addressing unmet medical need in the hematology/oncology space. We looked at -- from a biology standpoint of view we looked at a lot of things. Sometimes we didn't do it because we think people demand too much money and we never -- we don't think we can really genuinely contribute to our shareholder, even if we did it. But we are very diligent, we have a very, very aggressive in-licensing, pretty much looking at every single hematology/oncology opportunity out there.

In terms of early stage, I think in biotech early stage is all relative. We as a company in general, we don't like to take biological risk. CAR-T 19 may sounds like a early stage compound from a clinical stage standpoint of view. But the biology is very well proven that, as a matter of fact, even with our CAR-T 19 program, they -- this same drug has already treated more than 100 patient, I believe. And the data is as good or it's not better than Novartis or a Kite data. That's why although it's only in Phase 1, we don't believe this is actually about taking the same risk as biotech company in the US bedding [Phonetic] on the Phase 1 oncology program with no clear biology validations.

Again, CD38 is a very well-validated biological target. Taro is doing over $3 billion a year, globally. And Taro has only been approved in China in 2019. It's a very young drug in China. We believe our CD 38 potentially is the best in class, because there is less infusion reactions in the primary data. So we will see in Phase 1 if we had a few people data we will actually immediately know if our infusion reaction is truly much better than the existing drug on the market.

So yes, it sounds like we're taking early stage compounds, but these are very, very well proven biology in the sense. And we really like to build a company, not -- the major distinguished aspect of CASI is, we're not taking some of the biological risk like the hundreds of biotech company publicly traded on NASDAQ, really the biggest risk in my 20 years of biotech investing is a biggest the risk some time is the biological risk for innovative compound, but we think actually we're taking a very little biological risk. And we are more really kind of leveraging the big growing Chinese market with innovation happening globally. So hopefully we can convince you in the long run that CASI is relatively low biological risk company. Does that answer you question?

Nathaniel Calloway -- Edison Group -- Analyst

That helps a lot. Yes, that's very helpful. That's all the questions that I have. Thank you.

Wei-Wu He -- Chairman and Chief Executive Officer

Thank you.

Operator

[Operator Instructions] Your next question comes from the line of Beth Senko. Beth, your line is open.

Beth Senko -- Zacks Small Cap Research -- Analyst

Hi. Thank you, guys. And thank you for talking to us during these uncertain times. Unfortunately, Nath got all of my questions. And so, I'm actually -- I'm actually all done. But thank you for keeping us updated on what is happening here.

Wei-Wu He -- Chairman and Chief Executive Officer

Great. Yeah. Great. Thank you so much in this difficult time. But we are a big believer that 1.4 billion people in China will always wanted better medicines. Especially, medicine like EVOMELA which really, really is a function of cure for certain percentage of multiple myeloma patient. We are long-term investors, myself, and we think we're on our way to build a really, really fully integrated leading pharmaceuticals companies in China initially, but maybe even globally in the future, because some of our drug, we do have global rights.

Beth Senko -- Zacks Small Cap Research -- Analyst

Excellent.

Wei-Wu He -- Chairman and Chief Executive Officer

Yeah.

Operator

[Operator Instructions] Your next question is from Richard. Richard, your line is open.

Unidentified Participant

Yes. Thank you for taking our questions today. I noticed that your last press release was December 3. And with all that's going on in the world, it seems like that's kind of on a long time for radio silence for us back here in the States. I wonder if you could comment on that a little bit.

Wei-Wu He -- Chairman and Chief Executive Officer

Well, the -- I mean, I have been a biotech investor for 20 years and I -- sometimes people like to put out a lot of noises to have endless amount of press release. But the reality, our business is really about the patient. Can we truly make a difference for the patient. If we don't have major events, which we can make a difference for the patient and the opinion that we should really press release like this quarterly press -- year-end result to me is very important. We finally announced -- this company we took over has been in business for 20-some years never had a time of revenue. And we finally launched the first drug with a very excellent commercial team in little bit then over a quarter, we achieved $4.1 million revenue in China, that's actually -- I'll give my commercial team a gold medal for that.

So it's not like the US, all the market is $1 billion market. In China a little bit over a quarter, we achieved $4.1 million. To me that's great news. So I -- sorry to maybe sound a little bit arrogant, but we would rather our shareholder focus on our clinical program, can we we truly make a difference. Right? So our CAR-T 19, we think that's going to be our next major milestone, because this is a drug that has been proven by Novartis and Kite, now Gilead that it save lives. And we finally got approval. I think our -- so the approval by the Chinese regulatory agency is a major milestone, because in China there is 300-some CAR-T company, they all claim they are in CAR-T, but very few of them are doing the real, like FDA sanctioned trial. And we are the one of the first Chinese domestic CAR-T got approval.

As a matter of fact, this quarter we are actually doing the Phase 1 clinical trial already. So these are -- to me this is a much more meaningful press release. So that's -- that might be the reason that -- and personally just be sharing with you as the CEO and Chairman of this company and a pretty reasonable shareholder, I'm on this company for next 10 years. We're not looking for short-term, we are really going to commit to build of next Takeda in China, next J&J in China. To me like temporary events doesn't even matter. We are committed to build this into a world class pharmaceutical company serving 1.4 billion people. And you will see my actions in the next 10 years. This is really something that we are committed with our life.

Unidentified Participant

Right. And I asked the question from the perspective of the share price falling in half in a matter of a month. And CFO leaving, and just kind of no news out of China. So it was a bit concerning not hearing anything and not even to the fact that, hey, we're getting through COVID-19 here, we are on track or a little bit behind schedule. We just -- well, the things you might to hear for some kind of update, especially when we're hearing all kinds of different kinds of news out of China?

Wei-Wu He -- Chairman and Chief Executive Officer

I hear you, Richard. Yeah, at -- we will definitely be -- actually the matter of fact today, it's the first time I think in the next -- last 10 years the company ever did a call. So we are taking -- I love to have more conversations with people like you and getting guidance on you. And I hear you.

Unidentified Participant

Well. I'm also a long-term shareholder and rather from our perspective anyway. But anyway, to move on, just one other question. As far as the manufacturing facility, I know you talked about the land a little bit, but what about the actual facility? Has construction started? And if it has, how -- when are you expecting completion?

Wei-Wu He -- Chairman and Chief Executive Officer

Well, Actually there are two buildings, it's already done. So it's really just which drug we want to manufacture first there. So we have definitely committed to building out the manufacturing. This is a big piece of land. Okay. So it's really -- it's good enough for us when we had a $1 billion revenue. Okay. So unfortunately we have not disclosed anything in detail, but we -- the reason we took the proactive measure to acquire this manufacturing facility is, yes, we ever hit a $1 billion revenue. I personally don't know of any integrated pharmaceutical company don't have their own manufacturing facility.

So by acquiring this piece of land very close to Shanghai. Shanghai is a really major pharmaceutical research hub in the whole China, and we are basically preparing for the long term. If you want to really push me that, what are we planning to manufacture, it's probably a few drugs that we really are betting on to commercialize and have a dominant position in China will be the drug that we will be manufacturing in our site. And we're planning to build out those site, preparing for big products we have. Right? So [Speech Overlap]

Unidentified Participant

Okay. Well, I don't -- Yeah. That answers my question. Thank you for your time. And it's kind of hard to look out into the future a little bit about our shareholders bidding, because we don't know what kind of restrictions on travel anyone is going to have. But hopefully this year we can -- you can meet million shareholders this year.

Wei-Wu He -- Chairman and Chief Executive Officer

Yes, yes.

Unidentified Participant

Thank you. Thank you for your time.

Wei-Wu He -- Chairman and Chief Executive Officer

Yeah, so just on the sideline. I was originally scheduled to have a non-deal road show, but that was canceled. So the virus is impacting us in many different ways. But personally, I believe the fundamentals of CASI is very solid.

Operator

[Operator Instructions] Your next question comes from the line of Joe. Joe, your line is open.

Unidentified Participant

Hi. Thank you for taking time here to share the current state of the company and the direction. We greatly appreciate it. I have -- yeah, thank you. I have a question as it pertains to having to go out to the marketplace and continue the funding a lot of the strategies you're putting in place in the future. So today, looking at what you presented online from year-end. It looks like we're almost at a 100 million shares to date. And we certainly are excited with the pipeline, can you share some of the constraints on time to actual market with many of the drugs? And where those struggles are occurring? And what if anything the regulatory challenges are that might be loosened to speed that time that could help that burn rate run a hell of a lot longer than what it is now, which appears to be about every six to nine months? You guys are going back into the market and we're all taken a serious haircut as you have to generate more cash and continue operations. It's been a struggle, quite frankly, for those of us who have been shareholders for a long time to see this continued reduction in value as you every nine months go out and grab more money to fund operations. I would appreciate any thoughts there. Thank you.

Wei-Wu He -- Chairman and Chief Executive Officer

Yeah. Joe, I think I probably would say, unlike a lot of R&D heavy biotech company in the US, their burn rate could be anywhere from $50 million to $100 million. Our burn rate even with all the clinical program we're supporting is, we're pretty frugal company, we're running at -- I think this year, our projected burn rate is $30 million -- around $30 million, and we have over $50 million cash in the bank. At current stock price, we probably -- I have no plan to raise any money at this price, because I'm -- with stock option and the money I putted into this company, I have about 10% of the company. I certainly don't plan to dilute myself too much. So this is shareholder to shareholder. And so the -- so we will remain frugal if this market and weather -- we're going to plan to be even more frugal if the market continue to be this negative. We have seen some of our fellow biotech company being hit really badly. But we're no different, because biotech as a whole is being perceived probably in today's market as a -- even have higher risk than Boeing and GE, right? So -- but personally I have no plan to -- I'll speak to the Board, we have no urgency to raise money, we will see. But our existing shareholders are always prepared to fund the company if actually needed. So we have a pretty big base of -- kind of like inside holders and we are really are committed to build this company for next 10, 20 years.

I can't speak for the market. So -- but there's one thing I'm personally very sure of is, the 1.4 billion people in China will always want to have better medicine. The only thing I'd probably will add is, we have finally turned this company into commercial. So there will be revenues coming in and -- in the next one or two years. I think if the market recovers, I really hope that the shareholder can distinguish us from many truly only R&D based company. So this is really my two sense. So we -- we are not planning to dilute our shareholder big time when the market is really -- the sentiment of the market is really, really negative. Right? So I don't know if that answered your question. But the nature of biotech unfortunately is, always have to raise money until you hit major commercial products. Right? I'm sure early days of Amgen, Genentech, Regeneron they all did that.

The ultimate goal is to have products on the market. And if you look at our pipeline, we have quite reasonable size market with very little biological risks already in place. And our burn rate is relatively low and frugal compared to the overall biotech industry in the US. So that's really the --hopefully this will comfort the shareholder a little bit.

Unidentified Participant

Yeah. So that's excellent. I appreciate that insight, certainly. Just one last clarification. Can you -- do you see anything in the future, near or short that might loosen up the regulatory requirements that might speed time to market in any of these drugs that are in their current state or are things --

Wei-Wu He -- Chairman and Chief Executive Officer

I don't want to speculate. I don't want to speculate too much, otherwise my [Indecipherable] yelling at me. I don't know. I mean, most of the drug we have is focused on oncology and I personally doubt -- I don't see anything in the immediate horizon that anything is changing. The ultimate data we can convince regulatory agency to approve our drug is to, we have to show our drug indeed had significant benefit to our clients, to our patients, right? So -- and there is no doubt in my mind that the drug we are licensing in is addressing those market and it has been proven to work, right? So -- and our CAR-T 19 has been used for 100 patient already. The data is already there. And it was just not -- the trial was not conducted under a Chinese regulatory standard, but we're going through that motion, and there is no doubt in my mind that this drug save lives.

CD38, that drug is -- the CD38 is a beautiful target for multiple myeloma, right? And I always say, in monoclonal antibody space usually the best monoclonal antibody is not the first monoclonal antibody. Look at HUMIRA. I think HUMIRA is, I think, number four, number fifth TNF inhibitor which did over $10 billion a year. So I think as we understand the biology of a particular proven target better, we do can create better molecules to address a multi-billion dollar market. And we are hopeful that our molecules is fits that criteria. Right?

So it's a -- so -- but in the end, we have to generate the clinical data to prove we are worthy of regulatory approval, right? So it's really the -- in the long run, I think CASI is really is a -- for me, I think it's a really a long-term hold. We are betting on the fast growing pharmaceutical market in China, we are betting on the cancer rate is going to increase in China, we're betting on a high percentage of aging population, we're betting on Chinese society overall is getting wealthier and can afford more expensive medicines. With that big trend we think pharmaceutical, biotech is globally -- personally, I think next 20 years is probably going to be the most innovative next 20 years in human history.

So if we have a entity called CASI, we have builded a functional commercial platform to bring in compound into this platform, getting that approved, commercialize it, show it to our partner that we can do a wonderful job of taking their drug into the marketplace. Personally, I don't believe that we will stop at the current pipeline we have. Our pipeline is only going to grow. The opportunity in the next -- I always say in the next 20-carat diamond, we don't even know where they are yet, but it will come, because we have one of the best platform to hunt for these diamonds and commercialize these diamonds and that's really the -- that's really as a CEO and Chairman and big shareholder that's all I care about. I hopefully will stick to that and make some really, really long-term shareholder value, create some long-term shareholder value. That's really the message I really like to communicate to our shareholders.

Unidentified Participant

Very good. Thank you very much for taking my questions.

Wei-Wu He -- Chairman and Chief Executive Officer

Yeah. Thank you so much. Thanks for being a royal supporter of CASI.

Operator

This concludes today's question-and-answer session. Dr. He, you may proceed with your closing remarks.

Yeah. Well, again at this very unique moment -- so, I would really -- I'm very grateful that you guys actually come to the call and being royal supporter of the company and be the royal supporter as analyst. As a -- as the CEO and Chairman, I feel even have a bigger responsibility. And we -- as the CEO, I know my number one fiduciary duty is to create shareholder value. And so, we will be very frugal and very careful with dilution. But we can only create shareholder value by taking care of our client, which is our patient. There is no doubt in my mind as a biologist and as an entrepreneur and as a biotech investor, next 20 years the growing pharmaceutical market in China and the growing innovation globally is really creating a unprecedent opportunity for company like CASI. There is no doubt in my mind that the opportunities are endless. And I really -- you can see from my behavior that, I'm a long-term shareholder, and I'll put money where my mouth is. And we will build one of the leading pharmaceutical company in China and maybe globally. And we like you to be our long term shareholders and thank you so much. [Operator Closing Remarks]

Duration: 53 minutes

Call participants:

Wei-Wu He -- Chairman and Chief Executive Officer

Larry Zhang -- President

Sean Lee -- HC Wainwright & Co. -- Analystg

Nathaniel Calloway -- Edison Group -- Analyst

Beth Senko -- Zacks Small Cap Research -- Analyst

Unidentified Participant

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