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CASI Pharmaceuticals Inc (NASDAQ:CASI)
Q3 2020 Earnings Call
Nov 9, 2020, 4:30 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good afternoon, ladies and gentlemen, and welcome to the CASI Pharmaceuticals Third Quarter Financial Results and Business Update Conference Call. At this time, all participants have been placed on listen-only mode. At the end of the prepared statements, participants will have the opportunity to ask questions. [Operator Instructions]

I would like to hand the call over to Cynthia Hu from CASI for a preliminary statement. Please go ahead.

Cynthia W. Hu -- Chief Operating Officer (U.S.), General Counsel & Secretary

Thank you, operator. Good afternoon and welcome to CASI's third quarter conference call. Earlier today, issued a press release providing the details of the Company's financial results for the quarter ended September 30, 2020. The press release is available in the Investor Relations section of the Company's website. Today's call will be led by Dr. Wei-Wu He, our Chairman and CEO. He, along with Dr. Alex Zukiwski, our Chief Medical Officer, Dr. Jim Goldschmidt, our Senior Vice President of Business Development, and I will also be available during the Q&A portion of this call.

As a reminder, our remarks today will include forward-looking statements, including our business plans, objectives, and milestones. These forward-looking statements are not guarantee of future performance, and therefore, you should not put undue reliance upon them. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those projected or implied in our forward-looking statements. For a description of important factors that could cause actual results to differ, we refer you to our statements in today's press release and in our SEC filings.

Now, it is my pleasure to turn the call over to our Chairman and CEO, Dr. Wei-Wu He. Dr. He, Please proceed.

Wei-Wu He -- Chairman & Chief Executive Officer

Let me begin by saying that we are very pleased with the progress we have made in the third quarter from both a clinical and a corporate perspective. I'm extremely proud of our team across all functions for their continued dedication and focus. There is no doubt in my mind that we are well on our course in building a leading biopharmaceutical Company. We will continue the momentum generated from our most recent in-licensed BI-1206 and from our underwritten public offering completed in the third quarter. With your support and our strong balance sheet, we will continue to make incremental progresses with our product portfolio and continue to aggressively pursue additional assets.

A few words about how we go about our pursuit of assets. We are pursuing assets with proven targets and on low clinical and biological risk, but we will be opportunistic in our hunt for what I'd to like to call diamonds to add to our pipeline. We are interested in products that fits our core competency in global drug development, allowing us to leverage China clinical development and the large patient population in China. We look at business development opportunities with an entrepreneurial eye. Specifically, we not only look at an asset's fundamental, global, development potential, but we also look at our partner's investment potential.

Our business development execution typically includes an investment component in our partner. We believe this additional layer of investment deepens our collaboration with our partners and signals our confidence and trust this venture approach has proven effective in developing all our cross-cultural [Phonetic] global relationships. It also provides our shareholders additional upside in the potential return on equity. For example, in connection with our CAR-T 19 commercial asset, CASI, through our China subsidiary, is also a major shareholder in our partner Juventas. We believe Juventas, a China therapy -- cell therapy leader with a pipeline of innovative cellular-based product, could potentially capture significant value from the Asian capital markets. The access to the Asian capital markets could unlock significant value for its shareholders, including CASI.

Similarly, CASI will be a shareholder of BioInvent, our partner for BI-1206. BioInvent is a publicly traded company on the Nasdaq Stockholm Exchange, and has a validated proprietary platform that generates promising new drug candidates to fuel its pipeline. In addition, CASI also is a shareholder of a spin-off company of Black Belt Therapeutics from which we acquired global rights to CID-103. Our style of venture medicine that is investing in our partners while jointly developing an asset together, one, greatly enhances our collaboration, and two, gives our shareholders an additional opportunity to capture value. This approach also reflects that deep experience and core expertise of our executive management and Board in both drug development and pharma investments. With this approach, we will continue to build our pipeline one set at a time.

I will now address our commercial product and then Alex will address our pipeline. We recorded EVOMELA revenues of $4.2 million for the third quarter. For the full year 2020 revenue, which is really our first full year of commercial activity, we expect to exceed $14 million in revenue. This exceeds what we have previously forecasted. As you recall, EVOMELA is approved in China for the use as a high-dose conditioning treatment prior to hematopoietic stem cell transplant -- transplantation in patients with multiple myeloma. Melphalan was previously not available in China and EVOMELA is not just melphalan, it is a proprietary formulation with patent protection until at least 2030. It is currently the only form of melphalan commercially available in China. And based on our strong line of work, with hospitals and medical centers, we have witnessed firsthand the strong endorsement of this product from our KOLs and physicians. We expect that autologous transplant will continue to be increasingly adopted as a standard first-line treatment for multiple myeloma.

Our EVOMELA post-market study is in progress. So far, the data we are seeing is consistent with published studies of EVOMELA. We expect to complete enrollment for this required study by the end of this year. Through EVOMELA as our first commercial product, we have built a commercial sales team that has been thoroughly [Phonetic] tested with the successful launch of EVOMELA, and now stands ready not just to expand EVOMELA but also ready to launch additional products such as our CAR-T 19 therapy. We will keep doing this, launching one product after another.

With that, I'm going to turn to Alex and Alex will give us an update on our pipeline drugs. Alex?

Alexander A. Zukiwski -- Chief Medical Officer

Thank you, He. Good afternoon. I'm Alex Zukiwski, the Chief Medical Officer of CASI, and for the next few minutes, I'm going to give you an update on the CASI pipeline. Let me first start with CNCT-19, our CD19 CAR-T asset. Our partner Juventas is making great progress with its current Phase 1 studies in B-NHL and B-ALL. These two trials are single-arm open-label, non-randomized, dose escalation Phase 1 studies to determine the safety and efficacy in the relapsed or refractory settings. So far, we are seeing a level of activity that is extremely encouraging. Based on the progress of the Phase 1 trials, we understand that Juventas expects to initiate the Phase 2 registration trials by the end of 2020. This is earlier than previously forecast. Needless to say, we are excited about with the progress that Juventas has made to date.

Now for a factor to highlight a little about CNCT-19. There are currently no approved CD19 CAR-T therapy products in China either produced by a foreign our domestic manufacturer. CNCT-19 will be -- it is locally developed and manufactured, which greatly distinguishes it from other CAR-T 19 therapies developed and manufactured outside of China. As you are aware, drug pricing still remains a substantial issue for patients in China, particularly for premium and innovative products. Comparable CD19 therapies that are developed and manufactured outside of China are subject to ex-China CMC and cost of goods, making the cellular therapy price point significantly higher than what we believe CNCT-19 can be priced at.

Next, I will address our most recent pipeline addition, BI-1206. We recently announced our in-licensing of BI-1206, a novel anti-FcyRIIB antibody for the greater China market. BI-1206 has a novel motive action, blocking the single inhibitory antibody checkpoint receptor, the FcyRIIB, to unlock anti-cancer immunity in both hematological malignancies and solid tumors. Fcy receptors are antibody checkpoints that modulate efficacy of tumor-directed targeting antibodies and immune checkpoint targeting antibodies used in cancer immunotherapy. BI-1206 can potentially be used in all therapeutic monoclonal antibodies that rely on ADCC our CDC for efficacy. It is BioInvent's lead drug candidate that is being investigated by BioInvent in a Phase 1/2 trial in combination with the anti-PD1 one therapy, Keytruda, generic name, pembrolizumab, and in solid tumors in a Phase 1/2a trial in combination with rituximab for the treatment of non-Hodgkin's lymphoma. We believe that by BI-1206 has broad clinical application with the potential to be used across multiple tumor types in many first-line indications and the refractory setting, which we plan to explore. Together with BioInvent, we plan to develop BI-1206 in both liquid and solid malignancies, with CASI responsible for the development and commercialization in Greater China. Our lead indication will be BI-1206 in combination with rituximab in patients with relapsed-refractory non-Hodgkin's lymphoma. We are now in the process of establishing our joint steering committee to kick start start our development plans in China, starting with our regulatory submission to the Chinese NMPA. We are excited to work with our new colleagues at BioInvent, and we'll have more to update at our next teleconference.

Now, let me move on to CID-103, which is the anti-CD38 antibody. CID-103 is a fully human IGT1 anti-CD38 monoclonal antibody, which recognizes a unique epitope. It was selected to have strong ADCC activity against CD38 positive malignant cells with the reduced DC activity, thus resulting in a potential reduction of infusion reactions, which are observed with existing anti-CD38 treatments. Preclinical data demonstrated that CID-103 has enhanced activity against a broad array of malignancies, expressing CD38, and potentially a better safety profile when compared to other CD38 monoclonal antibodies.

In addition, the results of in vivo studies have shown promising data that CID-103 outperforms what is currently available, and the data from the in-vivo efficacy models and preclinical toxicology studies have shown higher CD38 killing, high ADCC activity, which recognizes a unique epitope, improved safety profile with no overt-related infusion reactions. Less cytokine release, decreased binding to human RBCs for shorter administration time versus the competitors. We have recently completed a preclinical study in collaboration with the New York Blood Center. The study investigated the impact of CAD-103 on RBC pre-transfusion test methods, utilizing daratumumab as a positive control. CID-103 demonstrated very low binding to RBCs that was not detected by most blood bank test methods, independent [Technical Issues] of drug CID-103 significantly less RBC interference relative to daratumumab. While these observations are encouraging for laboratory testing of patients needing RBC transfusions, confirmation will be undertaken in the CID-103 Phase 1 clinical study. Based on this and other data we have observed so far, we remain encouraged that CID-103 has the potential to be a best-in-class anti-CD38 antibody, and I look forward to initiating our clinical study in the very near future.

As we guided last quarter, the COVID-19 pandemic impacted targeted start time of our CID-103 Phase 1 trial, but our expectations remain on track with what we have reported last quarter. We have filed our IMPD application to the MHRA, the British health authority, and to the ANSM, the French health authority, and we expect to initiate our Phase 1 study insights in both the U.K. and France as soon as the institutions are open for clinical activities, and we expect to start in Q1 2021.

As reported, the Phase 1 study of CID-103 will be a dose escalation study with an expansion phase to determine the safety and preliminary activity of CID-103 in patients with relapsed/refractory multiple myeloma. The trial protocol is designed to test a priming dose as well as dose escalation with the objective to reduce the infusion duration as recommended by the data review committee.

This completes the update for our three lead assets in our pipeline. Let me take you through a few of the other assets, which we have previously reported on. Our other assets include -- included in the pipeline are also progressing well. Our registration trial for Octreotide, long-acting injection, is on track to be initiated this fourth quarter 2020. And a registration trial for Thiotepa is in the planning stages and is on track to be initiated in 2021. We are also making progress with regards to our Wuxi manufacturing facility. We have started the early phase of construction and land improvements with fuller scale long-term construction plans in current discussions with the local Wuxi government. Please find additional information by referring to our website and filings. We are also happy to address any questions during our Q&A session.

With regard to COVID-19, the pandemic is still ravaging the global community, including our colleagues around the globe taking care of patients. Within China, we are observing a semi-balance and return to normalcy due to the tight and centralized response systems in place. We believe, overall, the impact of COVID-19 to our operations will be manageable as we close out the year and head into 2021. However, there is no assurance that this still evolving pandemic will not impact our supply, resources transportation, the hospitals where the studies are being conducted, our clinical sites, in which event we will quickly respond and adapt.

At this point in time, I'll turn the call back over to Wei-Wu.

Wei-Wu He -- Chairman & Chief Executive Officer

Thank you, Alex. So I'll give everybody some financial highlights -- a few words on our financial highlights for our third quarter. Our press release contains details of our financial results. Rather than read through all of these details, my comments today will be -- will address the key highlights. For the three months ending September 30, CASI recognized $4.2 million revenues [Technical Issues] primarily of product sales of EVOMELA that launched in August 2019. For the full year 2020 revenue, we expect to reach at least $14 million, performing better than previously forecasted. Our cost of revenues this quarter was reduced compared to last quarter due to transition to a newer manufacturer, resulting in decrease in the unit cost of inventories of EVOMELA.

As of September 30, 2020, cash and cash equivalents totaled approximately $74.6 million, compared to $44.9 million as of June 30, 2020. As previously reported, the Company did an underwritten public offering in July 2020, generating gross proceeds of approximately $43.7 million. This financing brought in additional long-term healthcare-dedicated financial institutions. Taking into consideration the cash and cash equivalents balance as of September 30, 2020, the Company has sufficient resources to fund its operations at least through 2021. We continue to be extremely thoughtful on how we deploy our cash with a focus on building shareholder value.

Before we turn this call back to the operator, we hope to have conveyed to you our optimism and CASI's positive outlook. The bottom line is, we are committed to building a major integrated biopharmaceutical Company using China as our initial market. We intend to increase our pace of acquiring assets and we will be tactical and entrepreneurial about it coupling clinical development partnerships with venture investment in our partners and we will continue to build and strengthen our R&D capacities further strengthen our sales and marketing team and expand the reach of our business development activities. It is an exciting time to be part of CASI, and we look forward to future updates as we hit our milestones.

I will now turn it to the operator for questions. Operator?

Questions and Answers:

Operator

We will now begin the question-and-answer session. [Operator Instructions] Your first question comes from the line of Sean Lee. Please go ahead.

Sean Lee -- H.C. Wainwright & Co. -- Analyst

Good afternoon, guys, and thanks for taking my questions. So we see EVOMELA revenues picking up. I was wondering whether you can provide with a -- provide us with a bit more color on the commercial opportunity there. For example, what percentage of hospitals and doctors on your target -- that you are targeting? Have you reached out to? Maybe what percentage of them have already ordered or used the drug? Like where do you think the room for growth over the next one to two years?

Wei-Wu He -- Chairman & Chief Executive Officer

Actually, our President, Larry, probably can address that question much better. Unfortunately, it's a very early morning time in China. He is not on the call. I will take a shot at it as I understand it. We think this is still a very early phase of launching EVOMELA in China because thanks to a few very mature multiple myeloma companies in China, they historically have convinced physicians that transplant is secondary to autologous -- transplant should be -- the drug is already as good as transplant, but -- so we are doing almost a reeducation of the physicians in China that for many patients transplant should be the first-line treatment and it has much better clinical outcome for many, many patients. So I think that the -- in terms of the commercialization of this drug and the -- it's still at the very early phase of its commercialization.

And the second comment I want to make is the potential of autologous transplant is still limited by the limited availability of transplant centers in China. For the top academic center, I'm pretty confident we probably have already detailed a majority of it, but we are seeing signs that even secondary hospitals are building out transplant centers. So we believe that the potential of this molecule or the potential of the autologous transplant procedures is much larger in China than probably we anticipated. And there is also potentially other utility of melphalan in other indications and we are kind of starting to explore. I don't know if that answers your question, Sean. Thank you so much for your -- always for your support.

Sean Lee -- H.C. Wainwright & Co. -- Analyst

No. That was very helpful. My second question is on BI-1206. It's nice to see [Indecipherable] very unique molecule. So I was wondering whether you can elaborate a little more on the exact structure of the deal. While CASI has the commercial rights to the Greater China, do you guys -- are you guys solely responsible for development in the area as well? Or is the development going to be a pilot process between you guys and BioInvent?

Alexander A. Zukiwski -- Chief Medical Officer

So Wei-Wu, do you want to address that or shall I take it?

Wei-Wu He -- Chairman & Chief Executive Officer

Yeah. You can take it. Yeah.

Alexander A. Zukiwski -- Chief Medical Officer

So the deal is for us that we are responsible for the development in the Greater China area. However, this is a true collaboration. As we look forward to registering the drug under the import drug registration pathway, our programs will be hand in glove with BioInvent. So the joint steering committee will dictate how the studies are being conducted, the targets, etc. So it will be a true collaboration in terms of the clinical development program on a global basis.

Sean Lee -- H.C. Wainwright & Co. -- Analyst

Does that -- should I take that as the drug will be developed more in the U.S. [Indecipherable] pivotal study either in China or in the U.S. or both before you take it for registration in China?

Alexander A. Zukiwski -- Chief Medical Officer

Sean, I would say that that's not entirely correct. We are working toward a true collaboration with BioInvent to establish and contribute to the Phase 2 program as soon as feasible. So we will be working toward filing all of the regulatory documents, which will enable us to participate in the global development program, which may not be a registration at this point in time. There may be an exploratory or signal searching study, etc.

Sean Lee -- H.C. Wainwright & Co. -- Analyst

Understood. What's...

Wei-Wu He -- Chairman & Chief Executive Officer

Sean, maybe I'd -- yeah, Sean, maybe I would inject a little bit a comment here, because I think there is still an underappreciation of the vast patient population in China, especially in oncology space, because China probably today is the Number 1 cancer incidence country in the world. And also the Chinese regulatory agency finally is part of the ICH. It's really actually I always say this is the first time in the 5,000 years China is part of the ICH. People probably are not quite really grasped the importance of that. So I think we are going to experimenting a clinical development strategy with some of our partner, which is, for instance, this drug if they -- if the BioInvent took this company into a global Phase 2 trial, we probably, I mean CASI, in China, we will become part of the global Phase 2 clinical trial, but we might be able to enroll certain patients faster and cheaper and more efficient than a lot of oncology centers in other countries, and that is -- we think that actually can add tremendous value to adding clinical data to important molecules like the Fc receptor inhibitor. So, does that make any sense?

Sean Lee -- H.C. Wainwright & Co. -- Analyst

Yup, and that's very helpful. And maybe you can comment us about a little more about the cost sharing on the clinical development.

Wei-Wu He -- Chairman & Chief Executive Officer

Can you say that again? I didn't catch that.

Sean Lee -- H.C. Wainwright & Co. -- Analyst

Sorry, maybe you can elaborate a little more on what's the cost sharing structure between you and BioInvent for the clinical development.

Wei-Wu He -- Chairman & Chief Executive Officer

Alex, you want to make a comment on that or I can take a shot on. The understanding is that, I mean, the costs in China, we will bear some of the costs in China.

Alexander A. Zukiwski -- Chief Medical Officer

Yeah. We will bear the cost for the development program. Jim?

James E. Goldschmidt -- Senior Vice President of Business Development

Yeah. This is Jim Goldschmidt. Yes, we -- the CASI will be responsible for all clinical costs incurred in China since that is our territory. But as Wei-Wu said, we will also have the right to participate in all global clinical trials and the sites that we get up and running and the patients that we recruit and enroll into those trials in China will be our cost.

Sean Lee -- H.C. Wainwright & Co. -- Analyst

Great. My final question is a bit of a higher level one. Now, with a good stable of drugs already in your portfolio, I was wondering whether you are still looking to in-licensing additional products. And if so, what's the exact timing for these? And also, are you only going to be -- going forward, are you only going to be looking to license products for the Greater China area or maybe for China and the U.S. markets, both? Thanks.

Wei-Wu He -- Chairman & Chief Executive Officer

We are very open-minded, right? So the -- if you look at our CID-103, we actually got the global rights of the CD38 CID-103. So we're not limited to China, but we think China is a great kind of the starting market for us, because we see the global arbitrage opportunity of China 1.4 billion people aging and has a high demand for innovative products globally. But China is also a wonderful clinical development market and -- but we are not going to limit ourselves to China market per se. Ideally, we love to have multi-billion dollar global assets, right. So that's the -- and so CID-103 is a great example that we own the global rights of CID-103. And we, by the way, own the global rights of our CAR-T 19. The question is, do we really want to launch our CAR-T 19 in the U.S., where there is already two products approved in the U.S.? It's unlikely, right? But that drug in other cost-sensitive market might be actually a pretty good drug.

And another comment is we probably will be extremely aggressive to add more drugs to our pipeline. That's -- we have stated in many shareholder meetings and CASI is going to be more aggressive moving forward to bringing assets into the pipeline.

Sean Lee -- H.C. Wainwright & Co. -- Analyst

Great. That's all I have. Thank you for taking my questions.

Wei-Wu He -- Chairman & Chief Executive Officer

Thank you, Sean.

Operator

Your next question comes from the line of Beth Senko. Please go ahead.

Beth Senko -- Zacks Small Cap Research -- Analyst

Two quick questions. Sean managed to get a lot of mine in.

Wei-Wu He -- Chairman & Chief Executive Officer

All right.

Beth Senko -- Zacks Small Cap Research -- Analyst

[Speech Overlap] the $4 million in EVOMELA sales, is that something we should consider normalized run rate given what's going on with COVID and things starting up and things still on and off is, is that $4 million, $4.5 million a good base to grow on from modeling going forward?

Wei-Wu He -- Chairman & Chief Executive Officer

We think so. I mean the China is pretty normalized with regard to the COVID-19 situation. And so, we are only going to grow from this base, right? So this is only the first year we launched a product for CASI. So, there are still a lot of things we're working out. We built in a commercial team last year. So it's a brand new team. It's a global standard team and they -- our team did a beautiful job. Now, for a niche drug like EVOMELA, we're targeting over $14 million in the first year. But that's really just the beginning, right? It's the first full year. You can argue that CASI's first drug ever in its history, right?

Beth Senko -- Zacks Small Cap Research -- Analyst

Sure.

Wei-Wu He -- Chairman & Chief Executive Officer

So it's at the very beginning. It's a very beginning of our commercial effort. So I personally expect to see number far better than this quarter.

Beth Senko -- Zacks Small Cap Research -- Analyst

Certainly. Certainly. I just wanted to make sure that we're not expecting that there was an extra channel fill this quarter and that the normal run rate is $3 million. So, just minor, minor thing in the big picture. Bigger in the big picture, would you be willing to update us on what you see as potential market size in terms of patients for some of these new drugs? I think when we last spoke the CAR-T 19, you were thinking 30,000 patients sort of annual sort of incidence rate.

Wei-Wu He -- Chairman & Chief Executive Officer

That's the total market, right? That's the total market.

Beth Senko -- Zacks Small Cap Research -- Analyst

Okay. Right.

Wei-Wu He -- Chairman & Chief Executive Officer

And the CAR-T 19 is still going to be relatively expensive drug, right? So the -- so -- and it's initially it's probably unlikely will be reimbursed by the government because it's high price. So we still -- we have not given out any guidance yet. But if you look at Gilead's drug, it's doing I think on the run rate doing about $1 billion a year, and obviously that pricing is much higher. We think that the initial number should be comparable to what Gilead is doing, right? So -- because China has 5 times more population, 4 times to 5 times population, but pricing would be low. So there is still a lot of variable in terms of pricing. And we are very actively following the drug ahead of us and our competitive drug. So -- but the good thing is clinically we're really, really moving forward. So I think we probably will be a little bit more comfortable to give you guidance, a little bit further into the market.

Beth Senko -- Zacks Small Cap Research -- Analyst

Absolutely. Absolutely. So, of course, my follow-up would be do you have any thoughts in terms of target market size to some of the other drugs? But my guess is you're going to say that it's too early.

Wei-Wu He -- Chairman & Chief Executive Officer

Yeah. It's probably too early. I think for our CD38, I mean, the big if is after we dosed 20, 30 patients next year, are we confident this is indeed the best in class molecule, right?

Beth Senko -- Zacks Small Cap Research -- Analyst

Right.

Wei-Wu He -- Chairman & Chief Executive Officer

If everything we see in preclinical holds true, then I'll be probably a lot more optimistic about this molecule. And we all know J&J [Indecipherable] is doing about $3 billion on CD38 already. It's a big molecule, right? So we probably will be a lot more confident about this molecule after we dosed a few patients basically. Right?

Beth Senko -- Zacks Small Cap Research -- Analyst

Can you remind me the length of time for those studies on the off-chance that this latest wave of COVID pushes out clinical studies in the U.K. and France for another six months or something? What's the start to finish time?

Alexander A. Zukiwski -- Chief Medical Officer

So the...

Wei-Wu He -- Chairman & Chief Executive Officer

Alex, [Speech Overlap], yeah.

Alexander A. Zukiwski -- Chief Medical Officer

The sites in France appear to be operating without too much interference from the COVID-19 pandemic at the present time. In the U.K., that's a different story. They felt the burden of the pandemic, but we anticipate first quarter, the first patient will be in, and by the end of the year, we will be substantially through the dose escalation study, which will carry on probably into 2021.

Beth Senko -- Zacks Small Cap Research -- Analyst

Okay. And when do you expect to report out on that? You have some mid-term point?

Alexander A. Zukiwski -- Chief Medical Officer

So we will report out at some point in time the ongoing study, just the status of it. But we will not provide any data until we are finished the dose escalation portion of the study.

Beth Senko -- Zacks Small Cap Research -- Analyst

Okay, excellent. Thank you so much.

Wei-Wu He -- Chairman & Chief Executive Officer

Thank you.

Operator

[Operator Instructions] Your next question comes from the line of Leland Gershell. Please go ahead.

Leland Gershell -- Oppenheimer -- Analyst

Hi, guys. [Indecipherable] Thanks for taking the question. To just ask about EVOMELA few more questions. In terms of the drivers there, want to ask if you're seeing any use in the caliber setting or that's really all driven by transplant in myeloma? And also wanted to ask about gross margins, with the improvement, are we reaching kind of a steady state gross margin or should we expect continued improvement going forward? And then I have a follow-up. Thanks.

Wei-Wu He -- Chairman & Chief Executive Officer

So, Alex, do you want to make comments on this or you are made to do it?

Alexander A. Zukiwski -- Chief Medical Officer

Sure. Leland, unfortunately, we don't have the specific data on the use of EVOMELA for patients with relapsed/refractory multiple myeloma that are not undergoing transplant at this point in time, but that analytical data gathering is of high interest to us. There is also other potential off-label uses which we are not promoting at all. We are promoting per label. And we are trying to carefully track that to understand who is using the product, etc. But unfortunately, we can't give you a detailed breakdown in terms of the number of the percentage of cases relative to a transplant versus non-transplant setting for patients with multiple myeloma.

Leland Gershell -- Oppenheimer -- Analyst

Okay. And gross margin...

Wei-Wu He -- Chairman & Chief Executive Officer

Yeah. In terms of cost of goods sold, you can see it in this quarter our cost of goods sold has reduced quite dramatically. It's because when we first launched our drug, we used a manufacturer was actually being wind down and we kind of backed them to manufacture last batch for us to get the drug approval and everything. But we -- our team has done a wonderful job of -- after we launched the drug, now, we shifted to a lower cost manufacturer. And I think our margin has improved dramatically. It probably will only get better. So -- but there might still be room for us to improve our margin. But you know we'll keep you updated on that.

Leland Gershell -- Oppenheimer -- Analyst

Okay, great. And then one question I have just on strategy with potential out-licensing of geographic opportunities that are outside of China for which you have the rights of resemble for CID-103. You may look to flip the ex-greater China rights to another commercial organization. Just wondering if you have any timelines in mind for when that might happen for these types of programs or if it's really dependent on the data and the level of interest that you get from the potential suitor as to when you might transfer other rights to another company. Thanks.

Wei-Wu He -- Chairman & Chief Executive Officer

Yeah. We probably will be opportunistic a little bit. I think because it depend on what we are betting on, right? So right now we're betting on the CID-103 is a better molecule than the molecule on the market regarding to infusion reactions, the red blood cell binding and the easiness of -- ease of administration. So if those -- we think right now, that's our -- we believe that, but that's not until we see some real patient data, it's probably going to be hard to convince a large pharmaceuticals to make a big bet on it.

So we probably are willing to bite the bullet and move forward and see how it goes. That's why I think for CID-103, next year is going to be a very pivotal year for us. So -- but we will be opportunistic and if a large company that do truly believe this is what we believe in, it doesn't prohibit us to do a deal earlier, right? So -- but obviously with clinical data, it will be a lot easier to convince a large player. And it will be strategic because we are building a commercial team in China, so we have access to market in China, but we don't necessarily have access to market in Japan or in Europe in the multiple myeloma space. So we probably would love to find partners have strong market access to those markets.

Leland Gershell -- Oppenheimer -- Analyst

All right. Okay, that's very helpful. Thanks for the additional color and congratulations on the progress.

Wei-Wu He -- Chairman & Chief Executive Officer

Thank you. Thank you, Leland.

Leland Gershell -- Oppenheimer -- Analyst

Yeah. Thank you.

Operator

We have reached the end of the question-and-answer session. I would now like to hand the conference back to CASI Chairman and CEO, Dr. He, for closing remarks.

Wei-Wu He -- Chairman & Chief Executive Officer

Well, I think this is -- thank you very much for joining the call. We believe CASI is at the very -- it's really at the very beginning of building a fully integrated pharmaceutical Company, leveraging global innovation, china cancer patient population, and the new regulatory innovation in China. The sky is the limit. China has 1.4 billion people ageing and people are also getting wealthier. The life sciences innovation, we look at globally, man, I think we're living in such a wonderful time since are getting -- being invented literally every day. You guys hear about the vaccine story for COVID-19 today. And so, I think we living at extremely exciting time. And we are grateful for the investors in our trust in CASI and it's -- our team is doing a great job and we're here to diligently execute our milestones to show to our shareholders that by investing in CASI, we may be able to do wonders and thank you so much.

Operator

[Operator Closing Remarks]

Wei-Wu He -- Chairman & Chief Executive Officer

Thank you.

Duration: 49 minutes

Call participants:

Cynthia W. Hu -- Chief Operating Officer (U.S.), General Counsel & Secretary

Wei-Wu He -- Chairman & Chief Executive Officer

Alexander A. Zukiwski -- Chief Medical Officer

James E. Goldschmidt -- Senior Vice President of Business Development

Sean Lee -- H.C. Wainwright & Co. -- Analyst

Beth Senko -- Zacks Small Cap Research -- Analyst

Leland Gershell -- Oppenheimer -- Analyst

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