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Athenex, Inc. (ATNX)
Q4Â 2019 Earnings Call
Feb 27, 2020, 1:30 p.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Greetings. Welcome to Athenex Fourth Quarter and Fiscal Year 2019 Earnings Call. [Operator Instructions]
At this time, I'll turn the conference over to Tim McCarthy of LifeSci Advisors. Mr. McCarty, you may begin.
Timothy Cook -- Senior Vice President, Global Oncology
Good morning, and thank you for joining our conference call as we provide an update on Athenex's business as well as a review of financial results for the fourth quarter of and fiscal year-end 2019. The news release detailing the results crossed the wire earlier this morning and available on the company's website. A replay of this call will also be archived on the company website. During the course of this conference call, the company will make projections or forward-looking statements regarding future events, including statements about financial, business and clinical milestones anticipated in fiscal year 2020 and beyond. We encourage you to review the company's past and future filings with the SEC, which identify specific factors that may cause the actual results or events to differ materially from those described in the forward-looking statements. You can find our SEC filings in the EDGAR database at www.sec.gov or in the Investor Relations section at our website at www.athenex.com. This morning, we are joined by Dr. Johnson Lau, Chief Executive Officer; Mr. Jeff Yordon, Chief Operating Officer; Dr. Rudolf Kwan, Chief Medical Officer; Mr. Randoll Sze, Chief Financial Officer; and Mr. Tim Cook, Senior VP, Global Commercial Oncology, who will be available to answer questions after the prepared remarks.
With that, I'll turn the call over to Johnson for introductory comments.
Johnson Y.N. Lau -- Chief Executive Officer and Board Chairman
Thank you, Tim, and thank you, everyone, for joining us this morning. The major progress Athenex made throughout 2019 and has paved a way for another exciting and productive year in 2020 as we execute our mission to become a global leader in bringing innovative cancer treatments to the market and improving health outcomes for patients. Our immediate focus is to obtain regulatory approval for our two most advanced candidates, oral paclitaxel and both of which have demonstrated success in Phase III clinical studies. In parallel, we continue to invest in and expand our commercial infrastructure, putting us in a strong position to launch and commercialize the first of our proprietary oncology therapeutics. Our candidate is which is partnered with Almirall as a treatment for actinic keratosis. We are delighted to share that we have already submitted an NDA to the FDA. We'll share more information once we have confirmation that the application has been accepted. Our is responsible for the record chip filing in Europe, and we'll be managing commercial activities in both the U.S. and Europe. The planned NDA submission for oral paclitaxel is supported by a strong clinical data package, including the results of our Phase III trial in cancer completed in 2019. This trial successfully met this prime efficacy endpoint showing a statistically significant improvement on overall response rate for oral paclitaxel compared to IV paclitaxel. We'll provide an update on a trial at the San Antonio Breast Cancer Symposium in December also announcing a conference that oral paclitaxel demonstrated a significant improvement in overall survival.
I would note that this is the first oral to demonstrate a significant improvement in response rate and overall survival in a Phase III study with much less neuropathy. We are on track to submit a NDA in the U.S. for oral paclitaxel. We will not be providing additional details at this time, but we'll share news of NDA acceptance by USFDA once it is confirmed. It is important to note that we developed this in monotherapy as the regulatory pathway. However, we all note that combination therapy is a standard in the present and future. We'll continue to explore paclitaxel as a backbone of chemotherapy going forward, including combination with targeted and immunotherapies. In December, we announced the expansion of our strategic partnership with our Chinese partner, Pharmaceutical, to exclusively develop and commercialize oral paclitaxel, oral and in China, Hong Kong and Macau. Pharmaceutical is a leading Chinese pharmaceutical company with proven R&D and commercialization capabilities in the region. And we are excited to collaborate with them to tap into one of the largest healthcare markets in the world. Under in terms of the expanded agreement, we are entitled to receive an upfront treatment of $30 million. And we are also eligible to receive development, sales and other milestones payments up to another $170 million as well as tiered royalties on commercial net sales of licensed products. The total deal size is potentially worth $200 million, excluding royalty payments. We look forward to leading the clinical development of this portfolio of our various clinical stage products with the ultimate goals of serving patients and addressing the very attractive market opportunities that exist in China.
Trends are under way to commence clinical trials. Having already secured a partnership in China, we've continued to explore the best options to leverage the value of our clinical assets in other territories worldwide. In the U.S., we have always believed that the most compelling strategy is to commercialize our paclitaxel ourselves. But we have active ongoing business development discussions with potential partners in other major markets in order to maximize the global revenue potential. I would add that beyond conventional out-licensing agreements, we are considering opportunities to collaborate on additional indications and explore combination therapies with partners. Product sales for the full year 2019 exceeded our expectations and came ahead of the guidance we issued in November. Jeff and Randoll will provide more details. Finally, we continue to maintain a healthy balance sheet. Cash and short-term investments at December 31, 2019, were $160.8 million. This includes the proceeds from the private placement we completed in December, in which we raised net proceeds of $59.4 million from a group of institutional investments. Randoll will provide you with more details on this transaction. I will now turn the call over to other members of the management team, beginning with Dr. Rudolf Kwan, our Chief Medical Officer, who will give an update on our R&D activities. Also joining us on the call today is Mr. Tim Cook, our Senior Vice President, Global Commercial Oncology. During Tim's discussion, he will provide information on the very positive reception we received in San Antonio.
He'll also provide an update on our prelaunch activities ahead of the anticipated oral paclitaxel approval. First, Rudolf, please go ahead.
Rudolf Kwan -- Chief Medical Officer
Thank you, Johnson. Let me begin with for the treatment of As Johnson mentioned, our NDA for has Independent submission is supported by strong clinical package, including two positive Phase III studies that demonstrate the excellent efficacy and a clean safety profile. We believe that represents a large and attractive market, and the commercial environment may get even more favorable in the coming years. We remain confident that tirbanibulin clean safety profile confirms a competitive advantage over existing AK therapies, which are limited by side effects that negatively impact patient compliance. has been stated that it plans to launch ointment in the U.S. and EU in Q1 2021 and Q2 2021, respectively, subject to regulatory approval. Now on to oral paclitaxel, and specifically, I would like to provide a recap of the data that we presented at the San Antonio Breast Cancer Symposium. We had announced earlier in 2019 that our Phase III study in metastatic breast cancer successfully met is primary endpoint. In the final analysis of the primary endpoint, we showed that patients treated with oral paclitaxel had an overall response rate of 40.4% compared with 25.6% for patients treated with IV paclitaxel, a difference of 14.8%. And this was statistically significant of a p-value of 0.005. These results were based on prespecified, modified intent-to-treat analysis. We were very excited to announce at San Antonio that treatment with oral paclitaxel also result in an improvement in overall survival in that trial.
In the prespecified MITT population, the medium overall survival for patients treated with oral paclitaxel was 27.9 months compared to 16.9 for those on IV paclitaxel, a difference of 11 months. The p-value was 0.035 with a asset rate of 0.684. Overall survival was a secondary endpoint in the trial. It was an objective endpoint that's generally regarded by oncologists as the more important end outcome in a cancer trial. This was a relatively early data. And I would note that we were able to show this survival benefit making the results all the more impressive. We believe the safety data of oral paclitaxel will be extremely compelling for both doctors and patients. There was an impressive reduction in neuropathy. Clinically relevant incidents of Grade two or higher neuropathy occurred in 31.1% of patients on IV paclitaxel versus only 7.6% for those oral paclitaxel. Neuropathy is a common dose-limiting side effect of taxane therapy that frequently results in the need for those reductions. There was also a decrease in alopecia with the side effect being reported in 48.1% of IV paclitaxel patients versus 28.8% for oral paclitaxel. Furthermore, GI adverse events were manageable with probiotics therapy. Given the strong efficacy data and excellent durability of oral paclitaxel together with the of an oral administration, we are extremely confident about our unique and competitive product profile. We believe that the body of data we have generated will help establish oral paclitaxel as the treatment of choice for patients receiving chemotherapy for metastatic breast cancer. As more oncologists in the U.S. have become aware of the potential of oral paclitaxel following these statements on their presentation, we received multiple inquiries and requests to support investigator-initiated trials.
We have been evaluating these requests, we plan to move forward with a number of these programs which will which we believe will give more U.S. physicians experience of the drug. And if approved, have ensured a successful introduction into the oncology community. Let me turn to our other studies of oral paclitaxel. Our Phase I program in cutaneous angiosarcoma started and growing about 12 months ago, and we reported early data from this study during 2019. The initial response rate at the time of data announcement was clear and convincing, with all seven patients who had received six weeks of treatment showing significant and visible reduction of the cutaneous angiosarcoma within one or two weeks of treatment. three patients that come click response based on VCs 1.1 criteria. We plan to submit additional data for presentation at medical meetings potentially in the first half of 2020. With respect to our Phase I/II gastric cancer trial, the combined oral paclitaxel with we are now verified by the expansion cohort and expect to report additional data later this year. Lastly, our Phase I trial of oral paclitaxel in combination pembrolizumab for the treatment of tumor is progressing nicely and a point determination of the dose, we hope to advance patients into the dose expansion cohort this year. This will enroll patients with advance or metastatic gastric or gastroesophageal or non small cell lung cancer into three independent cohorts to further vary the activity and safety of the study combination. We believe this is only the beginning in terms of the we expect to demonstrate for oral paclitaxel and our oral discovery platform overall.
I will now turn the call over to Tim Cook, who will discuss the positive reception from San Antonio and large operations for oral paclitaxel. Tim?
Timothy Cook -- Senior Vice President, Global Oncology
Thank you, Rudolf, and good morning, everyone. Our strategy from the very beginning has been to build an organization with a strong market focus with an integrated business model that can leverage our proprietary commercial platform, supply chain and manufacturing capabilities, building a successful specialty pharma business was the first step and has allowed us to build relationships and establish a supply chain in the oncology community. Our efforts to build out the commercial infrastructure for oral paclitaxel are now well advanced. And we are in the process of making key leadership hires for our medical science liaison team this quarter. We plan to have our account managers in place by midyear to begin engaging with commercial payers. With regards to our oral paclitaxel sales team, we plan to start hiring our initial 25 to 30 sales representatives beginning in the second half of the year. We will then supplement this group with another 25 hires, approximately three to six months post launch. We have conducted extensive customer segmentation work. And from our market research, we know that approximately 20% of high-volume accounts treat nearly 70% of the patients. We are focused on these hospitals in high-volume practices, and we will be able to begin our promotional efforts once we receive FDA approval. We plan to cover the remaining patient volume through nonpersonal promotion. We continue to have internal and external discussions on oral paclitaxel pricing and plan conduct more quantitative pricing research later in the year. By now, we have a good idea about the acceptable ranges for our product, which are similar to other branded breast cancer medications.
In 2019, we launched our Athenex oncology brand. Our goal is to increase awareness of Athenex and its products among healthcare professionals and emphasize our company's long-term commitment in the field of oncology. We aim to establish Athenex Oncology as a patient-focused entity, developing and launching bold and innovative cancer medications while providing a communication platform for patients and healthcare professionals alike. The brand was launched at ASCO last year, and we continued these initiatives at the most recent San Antonio Breast Cancer Symposium. In addition, we are now conducting market research to measure the baseline brand awareness, and then we will track our progress to increase this awareness throughout 2020. Our oral paclitaxel abstract at San Antonio was accepted for oral presentation, and it was selected for a prestigious press program and it received broad media coverage. For example, we generated over 20 original online and print articles and six video interviews of our investigator Dr. In fact, our program received over 68,000 social media impressions. Following San Antonio, we conducted 47 one-on-one interviews with breast cancer experts. The feedback we received has been favorable and is focused on our dramatic increase in overall survival and the significant decrease in peripheral neuropathy. As Rudolf noted, we have also received a steady stream of inquiries from physicians interested in conducting their own clinical trials of oral paclitaxel, which we view as highly encouraging. So in closing, the pre-commercial activities around oral paclitaxel are critical for the entire company and for all our stakeholders. We have an opportunity to create significant value, not just with the launch of our first proprietary product, but also with additional indications and new therapeutics as our pipeline matures. I look forward to progress updates on future calls.
I'll now turn it over to Randoll.
Randoll Sze -- Chief Financial Officer
Thank you, Tim. Product sales for the three months and full year ended December 31, 2019, were $14.1 million and $80.5 million compared with $19 million and $56.4 million, respectively, for the three months and full year-end December 31, 2018. The decrease in product sales in the three months ended December 31, 2019, as compared to the same period in 2018 was primarily attributable to lower sales of pricing and Chongqing API. License and other revenue in the three months ended December 31, 2019, was $20.3 million compared to $2.3 million in the same period in 2018. The increase was primarily due to a $20 million milestone achieved during the three months ended December 31, 2019, in connection with the Almirall license agreement. We recorded $20.7 million and $32.7 million license and other revenue in 2019 and 2018, respectively. Cost of sales for the three months ended December 31, 2019, were $15.7 million compared to $14.3 million in the prior year. The increase in cost of sales was primarily due to an increase in the cost of specialty product sales of $4.6 million, offset by a decrease in the cost of 503B and API sales of $3.2 million. The increase in cost of specialty product sales was in line with that in specialty products revenue or the cost of 503B and API sales decreased at a slower rate than the respective sales due to continued fixed cost despite decreased production. Cost of sales totaled $69.6 million for the full year 2019, an increase of 48% as compared to $47 million for 2018. The increase in cost of sales was largely in line with the increase in product sales.
Research and development expenses for the three months and full year ended December 31, 2019, were $21.8 million and $84.4 million, respectively, as compared to $20.8 million and $119.9 million for the three months and year ended December 31, 2019, respectively. The year-over-year decrease in R&D expenses was primarily due to a decrease in in-licensing fees related to the license of PCR technology, product development and clinical operations, offset by an increase in preclinical development costs related to the arginine depravation therapy and TRT immunotherapy platform, an increase in R&D related compensation expenses. Selling, general and administrative expenses for the three months and year-end December 31, 2019, were $18.1 million and $66.7 million, respectively, compared to $11.6 million and $49 million for the three months and year ended December 31, 2018, respectively. The increase in SG&A were primarily due to costs related to preparing to commercialize our proprietary products. Net losses attributable to Athenex for the three months and year ended December 31, 2019, were $21.7 million and $123.7 million, respectively, or $0.28 and $1.67 per share, respectively. This compares to net losses for the three months ended of the three months and year ended December 31, 2018, of $27.1 million and $117.4 million or $0.41 and $1.82 per share, respectively. At December 31, 2019, the company had cash, cash equivalents, restricted cash and structure investments of $160.8 million compared to $107.4 million at December 31, 2018. I would note, our 2019 year-end cash includes $7.8 million funded by newer state for the construction of the facility, but does not include the $30 million payment we're due to receive from Pharmaceutical as a part of the expanded license agreement.
In December 2019, we closed with a number of institutional investors, a private placement and the offering of 3.95 million shares of common stock sold at a price of $15.30 per share. Net proceeds from the offering were approximately $59.4 million. Based on our current operating plan, we expect our cash and cash equivalents as of December 31, 2019, together with cash to be generated from our operating activity will enable us to fund our operations into first quarter 2021. In terms of product sales guidance, we expect 2020 year-over-year product sales growth to be in the mid-single digits from $80.5 million in 2019. While the company does not give quarterly guidance, we will comment that our products are expected to be back-end loaded in 2020. Our guidance for 2020 has taken into account our discontinuation of vasopressin cells and the suspension of operations at our API plant in 2019, which had meaningful contributions in the first nine months of 2019. For a more detailed discussion on our financials, including those specific factors that contributed to the changes in our income statement as well as financial results for the year ended December 31, 2019, please refer to the Form 10-K to be filed with the SEC.
I will now turn the call back over to Jeff Yordon.
Jeffrey Yordon -- Chief Operating Officer President
Thank you, Randoll. As Tim has already covered most of our pre-commercial activities, I'm going to focus my discussion this morning on our specialty pharma and compounding businesses as well as providing a brief manufacturing update. Product sales for the full year 2019 grew by 43% to $80.5 million. The increase in product sales year-over-year was due to a $20 million increase in specialty product sales from growing sales volume of existing products and the launch and sales of new products, along with an $11.8 million increase in 503B sales mainly attributable to vasopressin sales. I'm pleased to say that we were able to raise guidance twice during the year and then beat this guidance with the numbers we are reporting today, despite having discontinued sales of vasopressin as sales from our existing API plants in Chongqing in the second half of the year. Athenex Pharmaceutical division currently markets 30 products with 59 SKUs and the Athenex Pharma Solution markets five products and 16 SKUs. We expect to launch an additional seven products, including one significant 503 product, in the first half of 2020. There has been an important recent development in the 503b business with the closure of the compounding division at another major healthcare company. This has opened up a potential window of opportunity for Athenex, and we are currently evaluating this situation and will position ourselves accordingly. On the manufacturing front, the exterior of our facility in Dunkirk, New York is now complete, and we're in the process of completing all the interior work and the layout of the various suites. The equipment will be ordered in March, April of this year, and the plant is expected to be operational by June 2021.
We expect to manufacture our injectable and 503B products, and eventually, our proprietary oncology products for commercial sale at this facility. At our plants in Chongqing, China, we are only currently producing API for our own clinical trials and registration needs, and we are not producing commercial batches of API due to the decision we made to suspend commercial production based on discussions with the Department of Emergency Management of Chongqing. The department has agreed that all manufacturing activities that are related to the approval of oral paclitaxel can be continued without interruption. It should be noted that we also have an alternative source of API for our oral paclitaxel that is ready to supply the same high-quality material and backup contingency plans to ensure there are no disruptions to our approval and launch. We also want to emphasize that we are continuing to explore licensing opportunities of our proprietary products on a global basis. We continue to make progress with the new 40,000 square foot API plant which is being built to U.S. CGMP standards. As mentioned previously, construction on the new API plant has been completed. As a result of the recent outbreak of novel coronavirus in China, most businesses in the country have experienced suspension and subsequent delay of resumption of operations to various extents. We expect there will be some delay in building out this new API facility in Chongqing, and it is currently expected to commence operations in the second half of 2020. Once operational, the facility is expected to expand API production capabilities to further support our global clinical development needs and to ensure the supply of API for commercial launches. I will now turn the call over to Johnson for closing remarks.
Johnson Y.N. Lau -- Chief Executive Officer and Board Chairman
This is a very exciting time for Athenex. The innovative work performed by our R&D and clinical teams has resulted in two late-stage clinical assets with very positive Phase III data and the potential for each to change the standard of care in their respective markets. The NDA for has been submitted, and together with the planned filing for oral paclitaxel, we believe we are on the path for both of these products to be launched commercially in 2021. In parallel with these regulatory activities, we have been making the necessary investments in our manufacturing and commercial infrastructure to ensure a successful launch for oral paclitaxel upon approval and capture maximum value. We are pleased also with the progress we have made advancing our pipeline and continue to explore opportunities where there is strong clinical rationale for applying our platform and other platform technologies.
I would now like to open the call for questions. Operator, please go ahead.
Questions and Answers:
Operator
[Operator Instructions] My first question comes from the line of Robyn Karnauskas with SunTrust. Please proceed with your question.
Robyn Karnauskas -- SunTrust -- Analyst
Hi, everyone, this is going on for Robyn. Congrats for the quarter and all the progress you guys have made. I know you said during the call, you won't share a lot of details around the NDA until it's been accepted. But I just want to get some clarity. Are you saying that you're going to file the NDA after the final FDA meeting regardless of the outcome of the meeting? So then possibly around July, we can probably expect an update on the outcome there? Just really quickly there first, and then just a few more follow-up questions.
Rudolf Kwan -- Chief Medical Officer
We certainly have are very confident with the data package we already have from the Phase III study and from our ongoing discussion with the FDA. So this final discussion with the FDA in early April would be the last pieces we want to cross off before we make a submission. As we indicated before, we are going to make the announcement of acceptance of the submission. So we have no intention to make a public announcement of the submission itself.
Robyn Karnauskas -- SunTrust -- Analyst
Okay, great. That's very helpful. And then, I guess, A quick question on the angiosarcoma. I know there was a lot of excitement around that when you guys have put out data. If you can just talk a little bit about how enrollment is going and how many more patients we may expect? And then when you would think you would want to talk to the FDA about our regulatory path forward for that indication?
Rudolf Kwan -- Chief Medical Officer
Very good question. As you know, angiosarcoma is rare disease, and we obtained orphan drug designation from the FDA and late last year also from the European health authority. And our early data, obviously, is a driving point in getting those designations. And as the rare disease, our enrollments actually very rapid. We have been enrolling very, very well since the study started in about 13 months ago, and we continue to generate exciting data. What we have reported in the first seven patient has now been extended to a lot more patients, and you will expect to see those additional data being communicated to medical community very soon. And of course, we are in the process of planning to interact with the FDA to find the regulatory path forward. And of course, this will you'll expect that we'll very soon, that as soon as we got information about that, we'll be making announcement of the regulatory path for so stay tuned on that one.
Robyn Karnauskas -- SunTrust -- Analyst
Great. And then I guess, one real last one for Tim. Can you talk about how talk about the field team, do you have a fully state targeted 70% of the accounts that you had mentioned? Or just where along in the launch process are you in filling out the field team?
Timothy Cook -- Senior Vice President, Global Oncology
Sure. This is Tim. Thanks for the question. We are in the early stages of building out the sales team. We're starting really with the medical team first, the medical science was ones because they can begin engaging the thought leader experts immediately. We'll follow them with our account managers who will be engaging the payers, we engage payers a population based decision-makers well in advance of approval through a program called the Pre-approval Information Exchange Act. And so that will be our second phase. And then in the second half of the year, we will start bringing on our sales force as they have limited things they can do prior to pre-approval. So it's a phased approach. Science first, then payer then the sales team. And the goal being that they're in place and fully trained, ready to go whenever we receive final FDA approval.
Robyn Karnauskas -- SunTrust -- Analyst
Great, thank you so much, everyone for the questions.
Operator
The next question line of Kevin MacKay with RBC Capital Markets. Please proceed with your question.
Kevin MacKay -- RBC Capital Markets -- Analyst
Hi, thanks for taking the question. And congrats on the incredible progress through 2019, but activities and Athenex Oncology and a lot of the excitement at San Antonio. A couple of questions. It sounds like there's like delay, maybe a one month delay in the plan your actual filing in the U.S. to accommodate the final FDA meeting. I was just hoping I imagine you've already had some interaction with the FDA around either post Phase III, pre-NDA meeting, can you maybe just help us understand what remains to be discussed or agreed upon with the FDA prior to the filing? And again, help us understand why you're so confident that you'll be able to file after this meeting? And then maybe related to that, I was wondering if you could clarify if you've reached I'm understanding with the FDA one way or another, on a means of analyzing overall survival data, so that it could potentially be included in the label? Or maybe that's part of the upcoming April meeting. And then lastly, I was just hoping you could elaborate a little bit on any impact to Chinese operations regarding the coronavirus concern that's certainly seizing the new cycle here. Thank you again.
Rudolf Kwan -- Chief Medical Officer
Excellent question. We have a very strong package from our Phase III program in accordance with the FDA designed confirmed overall response rate as an approvable endpoint for Abraxane. So our clinical study clearly demonstrates, based on the primary endpoint, we win a very convincingly over well-performing active control arm with a significant, very significant p-value, both in the protocol specified analysis and the ITT. And in addition, all the survival analysis were in the right direction, especially the overall survival trend in the protocol, MITT even early stage is statistically significant with a difference of 11 months favor of So we are confident with the efficacy side. The safety side, the fact that we were able to achieve a dramatic reduction in the clinically relevant neuropathy is a strong point. the first oral taxane oral formulation of a compound as well-known and well-known to the FDA for So we are very confident with regarding the clinical data set as it stands to fulfill whatever the FDA would need for approval. As you rightly point out, we want to have the opportunity, as I article before, since the overall survival is an extreme pleasant upside that we did not plan for, we want some guidance from the FDA in order to maximize our chance of the label discussion, including at the survival data in there. So you are spot on that we certainly would take the opportunity to discuss this issue with the FDA. Your second question about the overall survival, I think I've answered that already. So your third question is on coronavirus. But before that, I will also give a little bit more favor why we call this a final FDA meeting. I think this is behind your question. We already have ongoing dialogue and they have been checking off all the preclinical CMC questions one by one with the FDA. And we as I indicated, we believe our clinical package is really strong enough. So really, the final discussions really on the normal formality of the submission format, checking up those last items. But more importantly, as I indicated, we want the opportunity to optimize our labeling discussion. Jonathan, you want to talk about the coronavirus?
Johnson Y.N. Lau -- Chief Executive Officer and Board Chairman
Yes. Just to add one more comment is that as Utah's already indicated, the discussion or communication is ongoing, and I'm joined to say that she has indicated that all the discussion with regard to DP clinical as well as the CMC package, everything. The discussion was very satisfactory. So therefore, the last that is the reason why Dr. Kwan is saying that this will be the last piece of information more on a discussion with regards to the clinical data. Now with regard to your question on coronavirus in China, how it affects our China operation. Obviously, as an organization, employees come first. So immediately, we have been assembling supplies to be shipped to ensure that all the employees who have supplied for them to be healthy, at the same time, to ensure that the environment is safe before we will ask them to continue the operation. Now let me emphasize the fact that the epidemic is not a company-specific issue and has affected many other companies and their business activities in China. We are now actively monitoring the situation, and we believe the impact our China operations remain manageable. Now as part of our launch corporation, we do have plenty, and we do have we have already activated backup suppliers for most of our most critical API products and also to work to secure also suppliers as part of the normal cost supply chain activities. I'm delighted to say that, based on our assessment, there will be no delay in any of our ongoing activities as well as no impact on the launch of products according to the regulatory approval date. Given the high uncertainties associated with the coronavirus epidemic at this moment is very difficult for anyone to predict how long these conditions will exist and except, which is this may affect but we will be closely monitoring the situation. And if the issue is resolved earlier than expected, then I believe this will only represent an upside for our organization. And I hope I answered your question.
Kevin MacKay -- RBC Capital Markets -- Analyst
Yes, you did. Maybe two quick follow-ups on that. The first, just wondering if you could confirm that the Araxa submission was still going through the 505(b)(2) pathway or whether conversations with the FDA had suggested maybe it should go through a different pathway. And then separately, for Johnson, you are one of the world's experts on virology and especially retroviruses was wondering if there was anything that could be done by the team to potentially start looking at treatment for coronavirus, given on the ground operations over there and your expertise
Rudolf Kwan -- Chief Medical Officer
First question, I can confirm that the 505(b)(2) track is still what we are working toward with the FDA. Some other priorities.
Johnson Y.N. Lau -- Chief Executive Officer and Board Chairman
With regard to your second question, I think that you are potentially witnessing the evolution of a virus that can evolve into a more source of recurrent events going forward. And obviously, the most important thing is whether there will be a host that the virus get high during the summer seasons. Now having said that, I mean, it was a to help. And then on top of by regular activities, on behalf of global health and humanity, I did help. And in fact, I was helping in terms of designing some of the early coronavirus vaccines as well as some of the diagnostics. And certainly, I mean, the board is fully aware, the boards have fully endorsed by participator to be able to help. And certainly, if there are good opportunities going forward, Athenex may be able to enjoy the upside of this new development as well. And all this has been fully communicated to the Board of Directors, and they are excited and they are encouraging us to be helpful. And I think, stay tuned. And if there's any new developments, we shall be more than happy to disclose the potential upside surprises for our stakeholders.
Kevin MacKay -- RBC Capital Markets -- Analyst
Thank you very much.
Operator
Next question comes from the line of Chad Messer with Needham & Company. Please proceed with your question.
Chad Messer -- Needham & Company -- Analyst
Great, thanks. Good morning. Thanks for taking my questions and congrats on all the progress, in particular, with the two NDAs to filed and pending one. One of your differentiating factors for Athenex is your manufacturing and supply chain store. I think Jeff for his update on it. But I was wondering if we could get a little bit more quantitative on your preparedness for an oral paclitaxel launch. I know in the past, we've talked about a potential need for up to five or six metric tons of paclitaxel to supply the market. Is that still your thinking? And where do you guys feel that you are in terms of being prepared to be able to deliver that?
Johnson Y.N. Lau -- Chief Executive Officer and Board Chairman
Our previous guidance was for the peak sales to be somewhere between two to four metric tons according to our assessment. It was based very simply on the number of patients that require therapy, the duration, the dose required and then you factor that into the amount of API required. And our plants are in China in will be able on to supply this with no issue. Now having said that, I mean, as the organization, they are fully integrated and to prepare for any potential interruptions based on our experience, we did with the help of Mr. Jeff Oden and others to set up plan B and plan C because for a critical medicine like oral paclitaxel. We have always we have the responsibility to ensure no interruption of supply. Now on this incident, I mean, the of the challenges that we are facing in China with some other factories having exposure in China, plastic chemical factory as well as the coronavirus issue were unexpected. But having said that, our preparation is now paying off in terms of the fact that we were able to activate the plan B in terms of other supplier. And also, we have another other supply just in case. As of right now, we have full confidence that we'll be able to be able to supply the API to the requirements or the needs of the patients, not just in the U.S. but globally. I will have to say that in case the issues we saw earlier, which we are monitoring very closely and be very supportive, this will only represent upside and very nice upside surprises for our organization and also for our stakeholders.
Chad Messer -- Needham & Company -- Analyst
Great. And obviously, most of our conversation today has been on your two lead programs, given the critical juncture they're at. But can we just get a quick update on a couple of the other things you guys are working on? The PCR and the arginase program, where do those sit today and what's the next thing to look for from them?
Johnson Y.N. Lau -- Chief Executive Officer and Board Chairman
Yes. First of all, as the CEO of the company, I would like to congratulate the clinical team for job well done. Now let me just give you some idea of the manager of the scope of work that they're working on. If I share with you that the file or the NDA for the file size is four gigabyte. Can imagine, the of the work that we're talking about in terms of NDA. And I'm very happy with the quality of the submission, and they are now working very actively on the oral paclitaxel. The timing is a function of the regulatory strategy as well as to ensure that we get the best label for the product so that our oncology commercial team will be able to do a good job in taking advantage of the label. Now with regard to the other programs, they are all advancing. But since most of the shareholders are focusing on the programs. We are also spending time on the top two programs. I'm delighted to report that they are very good progress with regard to the program as well as the arginine reprogram. There were some minor interruptions because of the coronavirus issue as well as some other supplies issue because you can imagine that some of the key suppliers that are require some of the products that we manufacture were interrupted by the recent events. But having said that, we are still very much on time, and you are going to hear more from us in the near future. And I will ask you to stay tuned. There will be more new developments to these programs as well.
Chad Messer -- Needham & Company -- Analyst
Alright, great. Thank you, Johnson. Appreciate the update.
Johnson Y.N. Lau -- Chief Executive Officer and Board Chairman
Thank you.
Operator
The next question is from the line of Kevin DeGeeter with Oppenheimer. Please proceed with your question.
Kevin DeGeeter -- Oppenheimer -- Analyst
Hey, great. Thanks for taking my questions. Maybe just following up on the earlier comments on the angiosarcoma update. Rudolf, will there be an opportunity in the upcoming medical meeting presentation to provide both some durability of response data for at least the subset of maybe some of those first seven patients, alongside response data for a larger cohort? Or should we expect the update to focus primarily on response rate?
Rudolf Kwan -- Chief Medical Officer
Good question, Kevin. Angiosarcoma really occurs commonly in very elderly patient population. The typical patient population in our studies were in the 80s or 90. There's another subpopulation very much in the post breast cancer surgery and radiation that subsequently develop kind of a irradiation-related secondary angiosarcoma. Those will be typically in the 60s or the 70s, OK? So those patients do not tolerate treatment generally very well. So durabilities in these and major question for those treatments. So we have already announced in the 30 patients, we saw very early response, which is a very good sign. So the question of durability would definitely be an area of focusing on to present in our presentation. We can say that we certainly are preparing for abstracts. Once they're accepted, we'll notify the investor community accordingly. And certainly, we're very pleased with what we are seeing so far. I think that you should expect to see some data certainly coming out.
Kevin DeGeeter -- Oppenheimer -- Analyst
Terrific. That's great. And then maybe as my follow-up question. I think, Jeff, in your prepared comments, you called out specifically singular exciting opportunity for a new product, a new 503b product. Could you expand a little bit more about that? Maybe just as we think about a little bit of context for the product sales guidance for the year, kind of how important is the introduction of any one or two products to really be able to sort of generate some what would be pretty meaningful growth off of the fourth quarter revenue run rate for product sales.
Johnson Y.N. Lau -- Chief Executive Officer and Board Chairman
Let me answer the question on behalf of Jeff. We do have a number of products to be launched.
Jeffrey Yordon -- Chief Operating Officer President
Johnson, I can answer the question.
Johnson Y.N. Lau -- Chief Executive Officer and Board Chairman
Thank you.
Jeffrey Yordon -- Chief Operating Officer President
We should introduce that product at the end of March. And I would like to, at this point in time, left the products stand until we introduce it. Certainly, you understand the changing climate in the 503b business with the most significant competitor exiting markets that offers us some very good opportunities. I have to be frank, we're not a big player in that market. But we have several products that we think by just increasing our staff in clearance, we can generate significantly higher market shares without really increasing cost much. So that first product you'll see at the end of March, another product you'll see probably in June coming out of APS. The upside is fairly significant. But we are very satisfied with where the sales forecast is now, and all of this just represents upside.
Kevin DeGeeter -- Oppenheimer -- Analyst
Right, extremely helpful. Thank you for taking my questions. Thank you.
Operator
The next question is from the line of Gagan with Labon Company. Please proceed with your question.
Gagan -- Labon Company -- Analyst
Good morning, and thanks for taking the questions and the congrats on all the progress. So far. I also have a question on the coronavirus, but take it from a slightly different angle. The FDA recently, you suggested there is about maybe 150 drugs that could be at risk if the Chinese APF manufacturing was delayed. So is that any of those things impact on, I guess, Jeff, your side of the operation? Or do you see any opportunity there you can pick up the lag?
Jeffrey Yordon -- Chief Operating Officer President
Yes. I think, first and foremost, is the fact that, certainly, our customers are concerned about products coming in from China. We try to explain that all of the products are made in isolated conditions with really no human beings involved. So as of right now, we think that we're OK from that standpoint. But to be honest, the delays that we're seeing mostly is in supplies of the most rudimentary things like paper for product portfolios, for inserts, for labeling. But we're handling all that. And in fact, we have a very significant launch of fulvestrant that just occurred with a Chinese company. So I think we're OK for now and these are important products, and I think the FDA is working closely with us.
Gagan -- Labon Company -- Analyst
Okay, great. That's helpful. And also just curious, in terms of the new API plants in Chongqing that you anticipate to be more fully operational in the second half of this year, would that replace all the capacity or the other stuff, the Tahoe plant that you no longer operate?
Jeffrey Yordon -- Chief Operating Officer President
Yes, Al, that is the plan, and we have much, much more capacity, better equipment. So the plan is eventually everything will move over to the new facility. I want to just state once again that the most important aspect of this, the government is working closely with us. Anything that has to do with the clinical needs to get Oraxol approved and on the market, they will allow us to do that without any restrictions. And that's the most important thing. And the only other thing I want to add from Johnson's comments about our raw material source is that not only do we have a secondary raw material source on paclitaxel, but also another one on So we're in a very, very good position. But no matter what happens, we should be able to have no interruptions.
Gagan -- Labon Company -- Analyst
Okay, great. That's very helpful. And maybe the last question, the housekeeping one. In terms of the $30 million, I guess, milestones from China, do you guys anticipate receiving that first half of this year? Or any time line you can suggest?
Randoll Sze -- Chief Financial Officer
In terms of revenue recognition is likely going to be a first quarter event getting the payment? You're right. I mean, we'll be getting it by the end of first half.
Gagan -- Labon Company -- Analyst
And should we amortize that or that will be something as both?
Randoll Sze -- Chief Financial Officer
No amortization. It will be booked as revenue, yes.
Gagan -- Labon Company -- Analyst
Okay, great. Appreciate it.
Operator
Next question is from the line of Matt Kaplan with Ladenburg Thalmann & Co. Inc. Please proceed with your question.
Matt Kaplan -- Ladenburg Thalmann & Co. -- Analyst
All right. Good morning. Thanks for taking the question. Just want to follow-up a little bit with Tim Cook in terms of the commercial preparations for and get a little bit more sense in terms of more color in terms of the size of the commercial force that you're thinking about to target the 70% of the physicians that you're going to emphasize initially.
Timothy Cook -- Senior Vice President, Global Oncology
Sure. Thanks for the question. Yes, we've been spending a lot of time in doing research, looking at what other companies have done and what's been successful. And so we feel that the right approach. And first, I'll just start out when you think of the commercial team, it's not just the sales force. It's the medical size, it's the account managers calling on payers. And then, obviously, it's the sales force. So what we've seen, though, in our research is that if we really want to be efficient and effective, there are about 1,700 accounts that we really need to focus on that represent treating 70-plus percent of the patients. And so our thought then is in terms of engaging those, the initial effort would be with approximately 25 to 30 so that we can execute with excellence. And then as we build momentum, we would bring on another 25 to 30 shortly after the launch. We anticipate having roughly seven to nine people calling on the payers, and we anticipate a medical sales force, our medical science liaison team of between four and six rep calling on the largest academic centers in the U.S. So that's the plan right now. Obviously, things can change if new information emerges, but we feel pretty good about the plan and we feel that we will be ready to turn on the efforts, the promotional efforts very quickly after FDA approval.
Matt Kaplan -- Ladenburg Thalmann & Co. -- Analyst
Great, great. That's very helpful. And I guess, second question, maybe more for Johnson. I guess, given the success of your first for discovery program through Phase III now and near-term NDA, can you give us an update in terms of the other programs you plan for that platform, including rinotecan and Taxotere potentially? And what your plans are for driving this forward?
Johnson Y.N. Lau -- Chief Executive Officer and Board Chairman
I'm delighted to say that the team is doing a very good job in terms of advancing the two advance programs. But more importantly is that, despite their very busy schedule, they're keeping the other products on this two platform to continue to advance. I'm delighted to say that, I mean, this part of our strategy in terms of timing, to ensure, first of all, to confirm that the platform works, followed by all the other products to follow. Because you can imagine that the regulatory path as a result of confirmation of the LEAP product will lead to a much more rapid and accelerated development of all the other products that follow, using the same strategy or the same platform. So I would like to say that stay tuned. There will be more data on other programs that we're working on that coming. Now on top of that, I'm also delighted to say that we have a very comprehensive product cycle management program. What it means is that on top of oral paclitaxel, the tablet is moving and advancing very well. We have other preparations, even for the PGP pump inhibitor. We have a second-generation already in hand. So if you ask me with regard to the quality of our product cycle management program, we have a lot of us being having big pharma experience. I can tell you that I will, we'll all be that we're very proud of our product cycle management program. So everything else. Everything is advancing, and we're delighted they are doing well, and you're going to hear more data soon.
Matt Kaplan -- Ladenburg Thalmann & Co. -- Analyst
Thank you, Johnson. Thanks for taking the questions.
Johnson Y.N. Lau -- Chief Executive Officer and Board Chairman
Thank you.
Timothy Cook -- Senior Vice President, Global Oncology
Thank you.
Operator
At this time, I'll turn the floor back to management for closing remarks.
Johnson Y.N. Lau -- Chief Executive Officer and Board Chairman
Again, thank you very much for your time. We have a very good year, and I'm delighted to say that the clinical team has done a tremendous job in terms of submitting the first NDA already. And the second one will come very soon, pending on our discussion with FDA, which I have full confidence that this is going to come very soon. I'm also delighted to say that the marketing team is doing a good job to prepare us for the success. And the business development team is also working very actively to ensure that we do not just capture the value of these particular products in the U.S. and Europe, but also capture the value of our products globally. And with that, I would like to say thank you for all the stakeholders for your support, and thanks, again, and we will talk to you again next quarter. Thank you.
Operator
[Operator Closing Remarks]
Duration: 65 minutes
Call participants:
Timothy Cook -- Senior Vice President, Global Oncology
Johnson Y.N. Lau -- Chief Executive Officer and Board Chairman
Rudolf Kwan -- Chief Medical Officer
Randoll Sze -- Chief Financial Officer
Jeffrey Yordon -- Chief Operating Officer President
Robyn Karnauskas -- SunTrust -- Analyst
Kevin MacKay -- RBC Capital Markets -- Analyst
Chad Messer -- Needham & Company -- Analyst
Kevin DeGeeter -- Oppenheimer -- Analyst
Gagan -- Labon Company -- Analyst
Matt Kaplan -- Ladenburg Thalmann & Co. -- Analyst
