Earnings Transcript for ATNX - Q3 Fiscal Year 2020

Operator: Good day, ladies and gentlemen, and welcome to the Third Quarter 2020 Athenex Earnings Conference Call. At this time all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to hand the conference over to Mr. Steve Rubis of Athenex. Sir, please go ahead.

Steve Rubis: Good morning and thank you for joining our conference call. Today, we will provide an update on Athenex's business as well as a review of financial results for the third quarter of 2020. The news release detailing the results crossed the wire earlier this morning and is available on the Company's website. A replay of this call will also be archived on the Company website. During the 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. Timothy Cook, Senior Vice President, Global Commercial Oncology. I will now turn the call over to Johnson for introductory comments.

Dr. Johnson Lau: Thank you, Steve. I'll provide a high-level overview of the progress Athenex made during the quarter and our future opportunities before turning the call over to Dr. Rudolf Kwan to discuss the clinical programs. In September, the FDA accepted our NDA for Oral Paclitaxel under priority review with a target action date of February 28, 2021. The acceptance of Oral Paclitaxel for FDA review puts Athenex in a strong position of having two NDAs under review at the FDA at the same time. The excellent progress made this year is that we are now closer to our goal of becoming a leading commercial stage oncology company. Within the context of COVID-19, both medical and patient communities continue experiencing greater demand for oral therapy options. We currently, for all chemotherapy, highlights the value of convenience around oral formulations. As discussed on previous calls, recent NCCN guidelines encourage switching patients from infusion-based therapies to an oral formulation when an equipment is available. Additionally, the FDA appears supportive of therapies that can help keep patients on therapy in the current pandemic environment. In addition to our chemical assets, our commercial team is now completely focused on putting all the key elements in place for a successful Oral Paclitaxel launch. Mr. Jeff Yordon and Mr. Timothy Cook will provide further details on the build-up of our infrastructure and commercial initiatives. The market opportunity in metastatic breast cancer is significant. Market research shows that Oral Paclitaxel will initially be prescribed mostly for breast cancer patients who are hormone positive, HER2 negative or who are triple negative. These settings represent roughly 70,000 patients annually in the U.S. Certain pathways exist to expand the total addressable market. These expansion opportunities include additional combination trials, other settings where Oral Paclitaxel represent standard of care and additional cancer indications. For example, the I-SPY 2 TRIAL is evaluating Oral Paclitaxel in early-stage breast cancer. If successful in these areas, the total addressable market can expand over time to more than 0.5 million patients. We also continue to work with our partners to get the regulatory strategy in place for China, Europe and other high-value geographic areas. Tirbanibulin ointment represent our first product to undergo FDA review. The PDUFA date for the review of tirbanibulin ointment is December 30, 2020. Almirall is our partner for tirbanibulin in the U.S. and European markets, and we are working closely with them on launch preparation. In September, Athenex reached another important milestone of having its 10 IND accepted by the U.S. FDA as the agency allow the IND application for TCRT-ESO-A2, a TCR-T cell therapy, targeting NY-ESO-1 positive solid tumors. In fact, TCRT-ESO-A2 is being developed by Axis Therapeutics, a joint venture between Athenex and Xiangxue Life Sciences Limited. The existing commercial business continues to perform well and beat expectations. Product sales revenue totaled $24.8 million in the third quarter, up 29% year-over-year. As a result, we are raising our full year product sales guidance from mid-teen to low 20s percentage growth. During the quarter, we further strengthened the balance sheet with a successful equity financing in September raising net proceeds of $119 million. This one funds provide us with additional resources to expand and strengthen our commercial infrastructure. They will also allow us to undertake label expansion initiatives for Oral Paclitaxel and further develop our pipeline. The planned commercial launch of Oral Paclitaxel will be funded by the nondilutive financings we recently announced with Oaktree and Sagard Healthcare Royalty Partners, which provide a combined total of $275 million. I will now turn the call over to our Chief Medical Officer, Dr. Rudolf Kwan, to provide an overview of our clinical programs. Rudolf?

Dr. Rudolf Kwan: Good morning, everyone. During the quarter, there were two important developments regarding Oral Paclitaxel. First, the NDA for Oral Paclitaxel was accepted by the FDA and assigned a PDUFA target action date of February 28, 2021. Ongoing dialogue with the FDA is encouraging and we are pleased with our progress to date. Second, the Company announced Oral Paclitaxel's inclusion as a study drug in the I-SPY 2 TRIAL. The I-SPY 2 TRIAL provides the opportunity to demonstrate the benefit of Oral Paclitaxel in early-stage breast cancer in combination with GSK's dostarlimab and anti-PD-1. The objective with I-SPY 2 is targeting a cure for breast cancer. The study arms inclusion of Oral Paclitaxel presents an opportunity for it to become the backbone vaccine of choice for combination treatment approaches. The trial design lead us to believe there is a good chance for the combination to work as IV Paclitaxel in combination with pembrolizumab, which is also an anti-PD-1 drug, has already been shown to be efficacious in this setting. Sites are actively dosing patients with the study drug. Regarding timing, other I-SPY trial arms have readout after roughly 18 months, which suggests the possibility of a data readout within this time frame. I-SPY 2 represents an important clinical trial in the context of the broader oncology arena, Quantum Leap's I-SPY clinical trials have been around for several years and several agents evaluated in the trial eventually went on to receive approval. The inclusion of Oral Paclitaxel in I-SPY 2 elevates the credibility of our program. Athenex is excited to collaborate with Quantum Leap and GSK. We have four Oral Paclitaxel abstracts accepted for poster presentation at the San Antonio Breast Cancer Virtual Symposium taking place December 8 to 11. These abstracts include a PFS and OS update from our pivotal Phase III trial in metastatic breast cancer, which will be presented in a spotlight poster discussion. The PFS and OS update presentation will be embargoed until actual presentation time. There are also posters on neuropathy and on the management of GI side effects. A further poster will present updated data from our Oral Paclitaxel angiosarcoma trial for the subset of patients who develop angiosarcoma of the breast. Currently, the primary focus for the Company is on the pending approval of Oral Paclitaxel and tirbanibulin ointment. Our life cycle management strategy for Oral Paclitaxel is our next important focus around label expansion studies, combination therapies and new indications. Our goal is to provide additional updates about our pipeline in the coming months. The FDA review of tirbanibulin ointment remains on track and we expect to receive a response from the FDA by the December 30, the PDUFA date. Almirall will be commercializing the product in the U.S. and E.U. upon approval. I will now turn the call over to Tim Cook for the commercial update.

Timothy Cook: Thank you, Rudolf. The final stages of commercial planning for Oral Paclitaxel are underway. The Company is prepared to launch immediately upon the FDA action date of February 28, 2021 or earlier. Let me recap our progress. Our medical science liaison team is in place and is engaging in scientific discussions with key opinion leaders. Our nurse oncology educators are on board and will provide information on dosing and managing side effects to the oncology treatment teams upon launch. In the meantime, the team will begin profiling its local territories and start having unbranded discussions around the disease state and patient care. We have hired two national account directors to engage with the payer community during the third quarter. Based on the Preapproval Information Exchange Act or PIE, the account managers may target payers establishing policy at a national level ahead of drug approval. Activities focused on educating these customers about health care economic information pertaining to Oral Paclitaxel in order to facilitate coverage decisions and budget allocations. Athenex is in the process of hiring five corporate account directors to cover smaller regional payers and large integrated delivery networks like Kaiser. Our last step involves onboarding our sales representatives in the December-January time frame ahead of our expected launch. In parallel, we are wrapping up our work on the value proposition of Oral Paclitaxel to the payer community and finalizing our pricing and contracting strategy. Feedback has been overwhelmingly positive as payers view our drug as innovative, which is in line with our prior pricing assumptions. Contracts are in place with all key distributors and specialty pharmacies, and our distribution model is finalized. Developing patient outreach initiatives remain a key focus. Our patient support program is near completion. An additional point of contact is created in the specialty pharmacy hub to help manage both treatment and reimbursement as well as to provide a financial assisted system for patients. October was breast cancer awareness month. Athenex has been very active and focused on amplifying its share of voice and visibility around breast cancer through the month. The Company launched a guide to facing metastatic breast cancer on October 9 and held a virtual media tour featuring Dr. Beth DuPree, which consisted of TV and radio interviews accompanied by social media post across multiple platforms. Core marketing messages to be used by our sales force are in the final stages of development. Our market research shows that our messages around efficacy and the first oral taxane resonate well. Physicians are responding positively to the safety language around neuropathy, no need to pre-medicate patients and a lack of infusion reactions. We will have a presence at the San Antonio Breast Cancer Symposium. In addition to the four abstracts that Rudolph mentioned, we will also have a virtual exhibit. Lastly, we finalized the brand campaign for Oral Paclitaxel that will roll out after launch. To summarize, we are ready to launch Oral Paclitaxel upon approval. Payer outreach has begun and we have prepared initiatives targeting physicians, office staff and patients. Additionally, we are planning several virtual physician outreach events that can be rapidly deployed upon approval to promote the drug. Now I'll turn the call over to Jeff Yordon, our COO.

Jeff Yordon: Thank you, Tim. Our strategy at Athenex focuses on building a company for the clinical, regulatory, sales and marketing, and manufacturing functions are vertically integrated and having all these elements in place well ahead of a planned commercial launch. Doing so provides the ability to hit the ground running once we have our first approval. It also means we can capture value across the entire supply chain. In terms of production, our current API facility in Chongqing is ready to supply product for launch as well as for planned clinical trials. A leading manufacturer in Europe is in place as a second source of high quality supply for our launch. The expectation remains that Polymed's new China-based API facility will be operational later this year and can begin commercial production in the second half of 2021. Construction of our facility in Dunkirk, New York is almost complete as all interior and exterior work is nearly finished. The essential equipment for the Dunkirk facility is on order, which should be delivered in 12 to 14 months. The facility is large with more than 400,000 square feet which will serve our commercial needs and those with specialty pharmaceutical business as well. The plan is to dedicate a portion of the facility to manufacturing 503B products as well as injectable products and eventually manufacture our proprietary products as well. APD currently markets 30 products and 54 SKUs, and APS markets six products and 18 SKUs. I will now turn the call over to Randoll to discuss the financials.

Randoll Sze: Thank you, Jeff. Revenues from product sales totaled $24.8 million for the third quarter compared to $19.2 million a year ago, an increase of 29%. The growth was primarily driven by specialty product sales as the impact of the global health pandemic led to increased demand for COVID-19 related drugs. Within product sales, revenue from the specialty pharmaceutical business for this quarter totaled $24.5 million, which once again beat our forecast. The increase was partially offset by a decline in API and 503B product sales as we suspended production of commercial batches at our API facility and this continued rate of present sale. In the third quarter, pursuant to the 2019 Xiangxue license agreement and an out-licensing agreement with PharmaEssentia, we recognized $9.4 million in license revenue, net of $0.6 million VAT and $1 million in license revenue respectively. Cost of sales totaled $24.5 million compared to $17.1 million a year ago. Cost of specialty product sales increased in line with revenue growth. We continue to incur fixed costs despite decreased production at our API and APS facilities. Out of the $24.5 million cost of sales, approximately $2.4 million was attributable to the sublicense fees payable to Hanmi in relation to the license revenue recognized associated with the 2019 Xiangxue license agreement. R&D expenses totaled $18.4 million compared to $19.6 million a year ago. Decline in R&D expenses was a result of all Phase III studies winding down as well as decreases in drug licensing costs, regulatory costs and pre-clinical operations costs. The decline in R&D expenses were partially offset by an increase in medical gears and API devaluing costs, and compensation expenses. SG&A expenses totaled $22.2 million compared to $16.3 million a year ago. Commercial preparation is proceeding with our proprietary drug drove the increase in comp. Operating loss for the quarter was $29.6 million compared to $33.6 million a year ago. Of note below the EBIT line, we recognized a $3 million loss related to the assignment of a portion of the senior secured loan from Oaktree's co-investors to Sagard. We did not incur expenses of similar nature in the same period last year. As a result of the foregoing, net loss attributable to Athenex was $36.8 million or $0.44 per diluted share in Q3 2020 compared with $34.8 million or $0.45 per share in Q3 2019. Excluding the onetime debt extinguishment expenses of $3 million, the net loss attributable to Athenex in Q3 2020 was $33.8 million or $0.40 per diluted share. In terms of our product sales guidance, we are raising our guidance again for the full year 2020. We now expect a year-over-year growth rate of at least the low 20 with this the mid-teen percentage growth that we communicated in August. This takes into account sales performance year-to-date as well as our outlook for the remainder of the year. Our product mix, we continue to improve products that are used to treat COVID patients though we do not view these revenues as recurring in nature. As a reminder, our guidance only includes product sales. We don't provide guidance on partnership revenues or milestone payments. As of September 30, 2020, we had cash and cash equivalents of $143.6 million, restricted cash of $13.8 million and short-term investments of $84.8 million. In September, Athenex completed an underwritten public offering of 10 million shares of common stock priced at $11 per share. The Company granted underwriters a 30-day option to purchase up to an additional 1.5 million shares, which was exercised in full. Net proceeds were $118.7 million. Based on our current operating expense, we expect our cash and cash equivalents, restricted cash and short-term investments as of September 30, 2020, together with the cash to be generated from our operating activities and the non-dilutive capital made available through the milestones associated with the debt agreement signed with Oaktree Capital and Sagard will fund operations into 2023. I will now turn the call over to Johnson for closing remarks.

Dr. Johnson Lau: Thank you, Randoll. I'm delighted to see the Company evolving from development stage to a commercial company, focusing on the registration and planned launch of two proprietary products. I want to thank my colleagues for their hard work and for their successful execution across the business throughout the year. We will now open the call for questions.

Operator: [Operator Instructions] Our first question comes from the line of Robyn Karnauskas with Truist Securities.

Robyn Karnauskas: So I just had a question regarding Oral Pac and checkpoint inhibitor combo. So for I-SPY 2, I just want to clarify. You talked about 18 months, that we're still on track for a year-end '21 or could it go into 2022? And then the follow-up would be for oral -- the Oral Pac Mayo trial, the tirbanibulin trial. Can you walk us through what you think your time lines are and how we should think about data coming out from that trial and the reads to I-SPY 2 potentially or maybe just a bigger picture opportunity for your drug from that trial next year?

Dr. Johnson Lau: Rudolf?

Dr. Rudolf Kwan: Robyn, the I-SPY 2 is one of the combination studies we are conducting. So in that setting, it was a combination with the GSK dostarlimab in neoadjuvant setting in metastatic breast cancer. The readout, as we keep saying, is based on really will be based on enrollment. The enrollment has started and it's moving along very well. But we cannot project the timing. Just looking at the previous time lines from I-SPY programs, the readout January occurs around 18 months after they start. So that's the time line that we have been using as a guidance, not really projection. Everything will depend on the actual enrollment rate. And we will know a lot more as we progress. We do have other anti-PD-1 programs already underway. The study O-11 with pembrolizumab is progressing well and we will be talking about it when the timing is right. And we do have plans in our life cycle management to include checkpoint inhibitor or immunotherapy combination as an important area. I hope that answer your question.

Operator: Our next question comes from the line of Kennen MacKay with RBC Capital Markets.

Kennen MacKay: Congrats on a very impressive year of execution so far despite the COVID-19 pandemic. First, one quick question on manufacturing and then I had another question on the combination of Oraxol with checkpoints that I was hoping Johnson and Rudy could speak to. So first, for manufacturing of tirbanibulin and Oraxol, the FDA is obviously very busy these days. Maybe you see there, more so than see there. But wondering if you could inform us as to whether the plants -- the manufacturing plants had been inspected by the FDA yet or whether this has been pushed and where you initially plan to manufacture commercial drug supply for each product. And then the second question on the Oraxol checkpoint combo. Maybe I was hoping you could talk on a little bit to some of the data that we've seen so far around paclitaxel and checkpoints specifically in breast cancer. I'm referring to the impact in 131 and 130 trial, and some of the differences that we're seeing there between Abraxane plus a checkpoint versus IV paclitaxel plus a checkpoint, obviously with some of the biggest differences being the need for steroid pretreatment and obviously some of the immunologic effects there.

Dr. Johnson Lau: For the first question on manufacturing, Jeff, do you want to make a comment?

Jeff Yordon: Yes. First of all, Kennen, the Oral Paclitaxel is being developed by a partner who has been inspected on a regular basis. So that facility is ready to go. Where we make the tirbanibulin ointment in Clarence, we have had several inspections with very, very good results. So the quick answer is there's no issue with FDA inspections that will not slow down anything. We're ready to go.

Dr. Johnson Lau: Just to add a little bit more, Kennen, we did communicate before that for the tirbanibulin ointment manufacturing in our own facility, the FDA inspection you know for the three citations. Basically, no issue at all. Now with regard to your second question on the combo therapy with IO and also in particular the study 13110 contrast between a vaccine and also the IV paclitaxel, Rudolf do you want to address this question?

Dr. Rudolf Kwan: Absolutely. It's interesting observation. I think probably a lot of questions will have to be addressed before one can definitively understand the difference. But on the surface, clearly the difference between the two study as you suggest the Abraxane did not use steroid and the IV paclitaxel arm presumably use steroid before each dose. So that is one difference. The -- our Oral Paclitaxel combination is very interesting. So first of all, it's different from the HER2 in it being oral, okay? And along the way, we certainly, like a vaccine, do not need steroid, no antihistamine. And our PK profile is interesting because there's a lot of talk about whether in the combination setting, what kind of dosing regimen will be the best dosing regimen in combination with immunotherapy. And that question has not been addressed for it yet. So there is obviously, with our PK profile, showing benefits in neuropathy and efficacy would be very interesting to look into. So we eagerly await our data from our study to see whether we can differentiate even better in the arena of combination of paclitaxel versus with the checkpoint inhibitor. So, Kennen, I hope I answered your question.

Dr. Johnson Lau: Kennen, I will add a little bit more color is that remember that for IV paclitaxel because of [indiscernible] using formulation, doctors said we use steroid, which you know is an immunosuppressive agent and antihistamines. There were publication in the literature suggesting that histamine on its own is also very important in the coordination of the T7 in response against tumor. So therefore, if you add all this together and assuming that this observation can confirm in clinical studies, I mean then the combination of both such P medications with IV paclitaxel because of Cremophor will not be present for Abraxane and look at that for Oral Paclitaxel, we do not need steroid and antihistamine as part of the P medications. I just want to highlight to you this interesting observation.

Operator: Our next question comes from the line of Jonathan Chang with SVB Leerink.

John Barrett: This is John Barrett on for Jonathan. Congrats on the progress. Regarding your upcoming SABCS presentation, can you help set investor expectations regarding the update?

Dr. Johnson Lau: Sure. We have four abstracts directly on the data and two on the suscept the usual management strategy highlights. Now for the four abstracts on the data, Rudolf, do you want to provide more details with regard to these abstracts?

Dr. Rudolf Kwan: Absolutely. The first poster on the spotlight presentation, title PD-1-08 Oral Paclitaxel and Encequidar versus IV Paclitaxel in the treatment of MBC patients, progression-free survival and overall survival, the data is embargo and it basically include an update analysis of the 001 data following the guidance with the FDA discussion on how to best further present the data and analysis. And these represent a new data cut from the last presentation in San Antonio a year ago. So certainly, I would encourage you to follow that presentation. The data is embargo, so I cannot talk about more about that. The poster presentation, the PS1305, is on the treatment of cutaneous angiosarcoma and the cutaneous angiosarcoma. One common group subgroup is breast cancer patients who had surgery and irradiation and years later present with angiosarcoma. And that's a very difficult-to-treat patient population. And certainly, we see very encouraging results coming up those data. And that poster will be presented with data. Then the PS1306 is a lower rate of neuropathy with Oral Paclitaxel and Encequidar, and again we will further present data focusing on the neuropathy. And PS1311 Oral Paclitaxel and Encequidar in the management of GI side effects, we'll present additional data regarding how those are managed in study 001 and how prophylaxis premedication has a positive inference in how we manage that. So I think those are the four posters that I encourage you really to attend the virtual symposium and see the data yourself.

John Barrett: And just one more. Can you provide a progress update on your other oral chemotherapies and when we might see datas for those programs?

Dr. Rudolf Kwan: Certainly, I can provide that. In a nutshell, we have been very busy focusing on two submissions. So the whole team, when you got two MTA review with the FDA and especially with the whole show being a parity review, the interaction with the FDA is really very constant and interactive and really focusing on knitting down those 2 approvals from our perspective. And certainly, also the COVID-19 environment do slow down the size enrolling patients. But we don't -- we haven't lost any focus on that. Our teams continue to look at that. And we are busily developing when we do a life cycle management is not only the Oral Paclitaxel, but all the other programs that include even, as you can see, the TCR-T IND approval recently, are all testament all those will be moving along. But certainly, COVID-19 did slow down enrollment in some of the program. So we will communicate that as soon as we can. And we are thinking of communication once we have decisions on the two PDUFA dates sometime in 2021.

Operator: Our next question comes from the line of Kevin DeGeeter with Oppenheimer & Company.

Kevin DeGeeter: Maybe just following up on San Antonio. With regard to the angiosarcoma update, should we expect an update on your duration of benefit across the enrolled cohort? Or should we think about this update as being more narrowly construed to the breast cancer population described? And just more generally on angiosarcoma, can you provide us an update to how you're thinking about regulatory strategies and next steps for that program? It is a smaller indication, but you've shown some really interesting data. How does angiosarcoma fit into the overall expansion of the addressable market for Oral Paclitaxel?

Dr. Johnson Lau: Rudolf?

Dr. Rudolf Kwan: Yes. Sure. It's very, very interesting indication. It's a small indication, but it is generating very intriguing data as we have present some already. The angiosarcoma program, what we will be presenting, is really the subset of the, I think, I believe there's seven patients in the angiosarcoma of the breast. And the study is progressing really well and we do have an Orphan Drug Designation from the FDA and we do intend to explore the approval in the U.S. based on the Orphan Drug Designation. And bear in mind, we also received the Orphan Drug Designation in U.S. as well. So that is an interesting indication. But as we speak, our priority is really knitting down the metastatic breast cancer. And the data in the poster, I cannot remember exactly, we'll be focusing on the seven patients. I don't believe we put in the -- all the study because that is more relevant for a later presentation. I hope I gave you enough color on that one.

Kevin DeGeeter: Yes.

Dr. Johnson Lau: Kevin, Johnson here. Before I ask Mr. Tim Cook to also provide you his opinion on the market potential, how are we going to position ourselves with regard to the oncologists is that our study in angiosarcoma generate a lot of reverse inquiry among the oncologists, the clinical oncologists. They are very interested in sarcoma, angiosarcoma and tumors alike. So in a way, this represents a very good opportunity for us to also create the momentum that we are seeing with the clinical oncologists already. Now with regard to the marketing strategy and whether it has any market sort of contribution to our launch, Tim do you want to make a comment?

Timothy Cook: Sure, happy to, Johnson. Thank you. The importance of angiosarcoma is really twofold. Number one, it really improves the overall perception of Oral Paclitaxel as an effective drug. This is a difficult disease to treat. And we're seeing rapid and meaningful responses. And so when you think about your drug, you want to make sure that you're creating a very positive perception of efficacy first. And so this certainly builds on the perception that I think we're creating with Oral Paclitaxel in the metastatic breast cancer setting. And here, we have a second disease setting that is difficult-to-treat that's showing really strong responses and rapid responses. Secondly, I would just say that while it may be a limited patient opportunity, they're very focused in where they're treated, mainly in major academic centers. So the ability to capture these patients once diagnosed is pretty high. And so this, again, while it may be a smaller niche orphan disease, it's very important to the overall perception and opportunity for the drug.

Operator: [Operator Instructions] Our next question comes from the line of Yale Jen from Laidlaw & Company.

Yale Jen: I've got two here. The first one is for Jeff, that as you look into the fourth quarter, you have the dynamics between the COVID-19 medication as well as the API and the 503B drugs. So do you see that mostly for the COVID-19 still be a major part of that? Or you see that dynamic being changed? And then I have a quick follow-up.

Jeff Yordon: Yes, Yale. We see it rising and falling. The hospital patients with COVID, we saw a significant decline and now in the last week or 2, we've seen an uptick again. So overall, I think that we will have a quarter that will at least be on track. And by raising the expectations for revenue tells you that we feel pretty confident that the year-end will be fine and the fourth quarter will come in about as we expected.

Yale Jen: The follow-up here is actually for the marketing side. You mentioned a lot of activity to premarketing activities and potential and also value proposition. Have you guys done any pharmacoeconomic studies on Oral Paclitaxel? And if so, would you guys be able to maybe publish that in the future?

Timothy Cook: We haven't done any on Oral Paclitaxel yet because we're not approved. Once we get on the market, we absolutely have pharmacoeconomic studies planned and would certainly publish those. But I will tell you, though, that we have done some important pharmacoeconomic looking at, for example, the overall cost of hospital treatment versus at-home treatment and showing that treating patients outside of the hospital in their own home is much more cost effective. That's data that we will be presenting at future conferences. We've also done a pharmacoeconomic study looking at the overall cost due to neuropathies associated with IV Paclitaxel. That is something payers are very interested in. We will also be publishing in the near future in managed care-focused journals. So while we don't have anything on Oral Paclitaxel yet, it is planned. But we have done significant pharmacoeconomics looking at, again, the difference between IV infusion and oral at-home and the overall cost of neuropathy to society.

Operator: Thank you. Ladies and gentlemen, this concludes our question-and-answer session. I'll turn the floor back to Dr. Lau for any final comments.

Dr. Johnson Lau: Thank you, everyone, for joining us today. This is an exciting time for Athenex and we appreciate your interest. By the time we have our full-year results call in late February 2021, we will hopefully have evolved into a commercial stage biotech company with proprietary drugs approved. And again, thank you for your time.

Operator: Thank you. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.