Athenex, Inc.

Good day ladies and gentlemen and welcome to the second quarter 2022 a Phoenix earnings conference call. As a reminder all participants are in listen only mode and the conference is being recorded. After the presentation there will be an opportunity to ask questions. To join the question queue you may press star then one on your telephone keypad. Should you need assistance during the conference call you may signal an operator by pressing star and zero. I would now like to hand the conference over to Kaylee Doherty, Director of Investor Relations. You may begin.

Good morning and thank you for joining our conference call. Today we will provide an update on the Phoenix's business as well as a review of financial results for the second quarter of 2022. The news release detailing these 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's website. During the call, the company will make projections or forward-looking statements regarding future events, including statements about financial, business, and clinical milestones anticipated in the fiscal year 2022 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.athenix.com. Speaking on the call this morning will be Dr. Johnson Lau, Chief Executive Officer, Dr. Dan Lang, President of Athenix Cell Therapy, Dr. Daryl Cohen, Chief Medical Officer of Cell Therapy, Mr. Jeff Yorden, Chief Operating Officer, and Mr. Joe Anoni, Chief Financial Officer. I will now turn the call over to Johnson for introductory comments.

Thank you, Katie, and thank you, everyone, for joining our conference call this morning. I'm extremely proud of our team's accomplishments in the first half of 2022. We have now raised approximately $125 million through the rapid execution of three complex deals, which include the sale of our Dunkirk manufacturing facility to Immunity Bio for $40 million, the sale of our turbulent U.S. revenues and EU royalties and milestones to Sagat and Oaktree for $85 million. We also announced another agreement to sell our China API business to the THA Capital, which will add an additional $19 million for a total of $144 million. We remain focused on prudent capital allocation and have deployed the combined deal process to reduce debt from $150 million to $57.5 million. As we discussed in the first quarter, we have also continually reduced headcount as part of our restructuring efforts and generated additional cost efficiencies. We continue to target a 50% reduction in operating expenses by year-end. In summary, We remain on track with our internal targets and our financial priorities remain unchanged. And we expect to continue to transform and strengthen the company's balance sheet through a series of asset divestitures, as well as more substantial and persistent cost reduction, which is related to the pivot of the company. So far this year, we have delivered the company and advanced our pipeline. We are not yet finished with the efforts to secure additional cash runway and are continually working on the other opportunities to leverage other attractive assets within the organization and are actively working on these initiatives which we expect to be announced in due course. At the same time, we have made tremendous progress pivoting the business towards advancing our novel NKT cell therapy platform. with potential to become an industry-leading franchise. We are confident that our innovative NKT cell therapy approach has promised to be disruptive to both the current and emerging cell therapy landscape. We continue to advance our clinical programs in both solid tumors and hematological malignancies with potential differentiation in safety, efficacy, and course over currently approved CAR-T cell therapy approaches. Our two lead clinical programs, CURE501, an autologous GD2-targeted CAR-NKT cell product for the investigational treatment of patients with relapse or refractory high-risk neuroblastoma, and CURE502, an allogeneic CD19-targeted CAR-NKT cell product for the investigational treatment of patients with PVC-treated hematological B-cell malignancies are demonstrating very encouraging dose response and favorable safety and pharmacokinetics in Phase I dose escalation studies. Doctors Dan Lang and Daryl Cohen, our new CMO of cell therapy, will provide a more detailed update on our CART-NKT Cell Therapy Pipeline shortly. Last quarter, we raised our product sales growth guidance to 20-25%, and I'm pleased to report that our APD and APS businesses are performing as expected. We're currently working on new product launches, margin improvements, and maximizing product shortage opportunities. Mr. Jeff Yoden will provide more details on these initiatives later. Data from the phase two, I-SPI-2, clinical trial of Oropracatexel in combination with doceramide plus or minus carboplatin in new adjuvant locally-advanced breast cancer patients are expected in the coming months. We look forward to updating you on this study. which is conducted by Quantum Leap Healthcare Collaborative. If the trial is positive and we graduate from the program, this means that there is at least an 85% chance of success in the phase three trial. In that case, we would look to monetize OPE as part of the pivoting process to create value. We remain on track with our regulatory interactions with MHRA and are submitting responses to questions received regarding use of olfactory taxol in metastatic breast cancer in the UK later this quarter. I'm extremely proud of our team's focus in executing on our strategic pivot and am highly optimistic about Apheonix's ability to transform into a lean and focused business. that is competitively positioned in the border immuno-oncology cell therapy sector. With that, I'll turn the call over to Dr. Dan Lang to discuss our CART-NKT cell therapy platform.

Dan, please go ahead. Thank you, Johnson, and good morning, everyone. Our strategic focus remains on advancing our differentiated and versatile CART-NKT cell therapy platform. with potential to overcome limitations of current immune-affected cell therapy approaches. The therapeutic value of NKT cells stems from their inherent ability to balance the best of both innate and adaptive immunity to achieve a highly effective off-the-shelf treatment that is much more tolerable and accessible to a broader patient population. This quarter, We further strengthened the core foundation of our CAR and KT cell therapy pipeline, clinically advancing our lead autologous and allogeneic candidates in both solid tumors and hematological malignancies. For CURA501, our autologous and KT cell products targeting GD2 in relapse or refractory high-risk neuroblastoma, we presented interim updates from our phase one dose escalation GeneKit 2 study at the ASGCT conference in May, demonstrating encouraging data from 12 children. A dose response supported by a 25% response rate was observed, with two out of three patients achieving responses at dose level four that included a durable complete response persisting for at least 12 months. Predictors of response included CURE501 exposure and CD62L expression, which is a marker for NKT cells that have central memory or stem-like attributes. We are seeing evidence of a dose response, and as we continue to explore higher doses, we expect to see deeper and more durable responses. Cure502 is our allogeneic CAR-NKT cell therapy product, targeting CD19 for the treatment of relapse or refractory hematological desymbolinases. Early results from ANCHOR, a phase 1 dose escalation study, were presented at the 2022 tandem meetings in April and demonstrated encouraging clinical responses in heavily pretreated patients with leukemia and lymphoma at the lowest dose levels of 10 million and 30 million cells per meter squared. A 60% response rate with two complete responses persisting at least six months was observed in the NHL cohort, including responses in patients who had previously experienced CAR-T cell therapy failure. Notably, we saw no cases of CRS in the lymphoma cohort. In the ALL cohort, one of two patients responded, which was a complete response that lasted six weeks. And there was three grade one CRS reported in the two patients. We are highly encouraged by the wide therapeutic window, meaning clinical responses are occurring at the lowest dose levels with good tolerability, which offers the potential for deeper, more durable responses through dose escalation. Importantly, we saw CURA501 and CURA502 CAR-NKT cells display a favorable pharmacokinetic profile that included cell expansion in all patients that peaked two to four weeks post-infusion. Both cells were detected at tumor sites, including tumor biopsies, peripheral blood, and bone marrow. Data from GeneKit 2 and Anchor both support a highly encouraging safety profile without any infusion reactions those limiting toxicities, neurotoxicity, graft-versus-host disease, or grade three or higher side effects related to CURE501 or CURE502. So we now have two phase one clinical trials in which durable objective responses were observed, which is remarkable. This early oncology drug development program for both solids and hematological malignancies. Curafibro3 is part of our preclinical program and is an allogeneic CAR-NKT cell therapy product targeting glapotin-3 or GPC-3, a liver protein abundantly expressed in hepatocellular carcinoma or HCC. Early preclinical data were presented at ASCO last month. Supporting enhanced therapeutic persistence and anti-tumor activity with GPC-3 CAR-NKT cells expressing the transcription factor BATF3 compared to those expressing IL-15. This work provides the foundation to support further clinical developments of Cura503, our GPC3 CAR and KT cell therapy product expressing BATF3 in patients with HCC. As the fourth leading cause of cancer-related deaths worldwide, HCC represents an area of significant unmet medical need that we hope Cura503 can successfully address. From a biological standpoint, we know that NKT cells are different than other cells being explored for use in cell therapy, namely NK cells and T cells. It is beginning to appear that this could be translating into more persistence, expansion, and better safety in the clinic from NKT cells. Collectively, our maturing clinical data continue to reinforce the differences between CAR-NKT cells and NK cells on T cells. And we remain highly enthusiastic that our pipeline with first-in-class potential offers the promise of meaningful therapeutic benefits to indications with significant unmet medical need. We are also exploring opportunities for collaborations where our NKT cell therapy approach has the potential to overcome limitations such as cost, efficacy, and access in other therapeutic indications. Lastly, I'm excited to introduce our new Chief Medical Officer for Cell Therapy, Dr. Derek Cohen, who has taken over leading clinical development, clinical operations, and regulatory affairs. Dr. Cohen is a hematologist-oncologist with over 25 years of oncology clinical research and drug development experience in both solid tumors and hematological malignancies. His proven leadership at top-tier pharmaceutical companies was accompanied by extensive experience in the clinical development, successful filings of DLAs and NDAs, and subsequent global regulatory approvals of several new cancer drugs over the past decade. His experience will help position us for success as we advance our investigational NKT cell therapy pipeline in the clinic. We are pleased to welcome Daryl to Athenix and look forward to working with him to bring these much needed products closer to regulatory approval. With that, I will now turn it over to Daryl to make a few more remarks and discuss the next steps for our clinical trial programs.

Daryl? Thank you, and good morning, everyone. I am truly excited to have joined Athenix at this pivotal time as the company strategically focuses its efforts on becoming a global leader in NKT cell therapy for patients with hematologic malignancies, but also for patients with solid tumors. My interest in Athenix was driven by the novel therapeutic potential of combining the unique intrinsic biology of NKT cells with the tumor antigen targeted approach of chimeric antigen receptors to create a disruptive innovation that could better address the challenges of and enable the transition of immune effector cell therapy to the treatment of patients with advanced solid tumors. This has already been evidenced in early phase one clinical trials, as Dan just summarized, which is both impressive and predictive of a high probability of technical success for both CUR501 and CUR502. Our clinical development program supports the investigation of autologous and allogeneic NKT cell therapy options for both hematologic malignancies and solid tumors. The potent anti-tumor activity without dose-limiting toxicity of our CAR-NKT cells is occurring at dose levels that are orders of magnitude lower than those needed to achieve clinical efficacy with CAR-NK or CAR-T cell therapies. This, in turn, enables us to safely dose-escalate and even repeat treatment cycles to drive deeper and more durable clinical responses. Looking ahead, first for CUR501, enrollment of additional patients into the phase one GeniKit 2 study at the two highest dose levels, dose level five, or 300 million CUR501 cells per meter squared, is ongoing. And dose level six, or one billion CUR501 cells per meter squared, is planned. We hope to make a go-no-go decision soon thereafter about whether to move forward to a pivotal registration-directed study based on the totality of safety, pharmacokinetic, pharmacodynamic, and antitumor activity results. As for CUR502, expansion of the single-center phase one anchor study into a multi-center phase one anchor two study is ongoing, and it's on track for activation this fall, carrying the possibility of reporting additional results shortly thereafter. And we continue to evaluate the possibility of investigating higher, greater than 100 million CUR502 cells per meter squared dose levels as in the GENIKIT2 study, as well as a multiple dose regimen within the same lymphodepletion timeframe in the hopes of safely enhancing the frequency and durability of clinical responses in this heavily pretreated B-cell non-Hodgkin lymphoma or acute lymphocytic leukemia patient population. Lastly, we still plan to file an IND for CUR503 in 2023 for the investigational treatment of patients with advanced GPC3-expressing hepatocellular carcinoma. As was also called out at this year's ASTCT and CIBMTR tandem meetings, allogeneic CAR-NKT cells offer the potential to be the Goldilocks of cellular therapies, namely the best of T cells in terms of manufacturing, including proliferation, post-activation, and cryopreservation, as well as memory and persistence, coupled with the best of NK cells in terms of tissue, lymph node, tumor, tissue homing, and avoiding graft versus host disease without the need for TCR gene editing. I am particularly enthusiastic by the outpatient off-the-shelf potential of NK T cell-based therapy, as well as its potential for improved safety, efficacy, and accessibility over other existing immune effector cell treatment options. I will now turn the call over to Jeff to discuss company operations.

Jeff? Thank you, Darrell, and good morning, everyone. At a high level, our business is now stronger than ever. Last quarter, I discussed the new United States partnership with Ampere and its injectable company, Abbott. We have already added the first three products from this collaboration and expect to launch them later in the year. Additionally, we have also identified the next 20 products from this collaboration, which will be launching in 2023. The majority of these products have markets that currently generate annual sales of approximately $40 million per year. but several have much larger markets with annual sales exceeding $400 million each. We believe that these launches can be a significant growth drive for our business. Another important update is that we have signed a partnership with Gland Pharma, a company focused on injection. This deal will allow Phoenix to significantly improve gross margin on our APS business. We have also licensed another significant product from Myla Pharmaceuticals, which is expected to launch in Q4 2022. Our team also has its eye on several other meaningful opportunities to launch products currently on the FDA shortage list later in the year which have historically been a revenue and margin generator for Phoenix. Immunity Bio, our new 503B contract manufacturer, has its New York State license in place and is actively filing for licenses in the other states. Now for the court. For our APS and APD businesses, Sales for the second quarter 2022 were $25.8 million, up 26% from $20.4 million for the second quarter in 2021. Broadly speaking, we finished the first half ahead of our plan with and cash flow positive. Year-to-date revenues for APD and APS are up 40% versus the first half of 2021. We launched Chemotrexib and Vortezamib upon market formation in May and are capturing revenue on both of these products. These products are expected to contribute significantly to increased revenues and margins of the overall business, though we do anticipate increased competition in the second half of this year, as more generics enter the market. In addition to the products launched in quarter two, we aim to launch an additional eight products in 2022, which include the new products from both M-Cure, Myla, and Mema. The Phoenix Pharmaceutical Division currently markets 31 products with 57 SKUs, and the Phoenix Pharma Solutions markets, six products, and 16 SKUs. We continue to take active steps to strengthen our business, improve margins, and diversify our product mix. And our efforts are paying off. 2023 promises to be an even stronger year based on our pending M-CARE launches and expansion to the other states in our APS business. I will now turn the call over to Joe Annone to discuss the financial.

Thank you, and good morning, everyone. As we continue in our season of breaking down and building back up, I am pleased to report that we are delivering on the plan we outlined on our first quarter call to divest non-core assets and reduce operating expenses. In the second quarter, we sold the Clissiri Royalty Streams for $85 million. And along with the first quarter Dunkirk sale for $40 million, we have in total raised $125 million from the sale of assets during the first half of 2022. Continuing on that plan, at the start of the third quarter, we announced the agreement to sell our China API business for $19 million, and we will continue to keep you informed as we execute on more strategic transactions during the remaining months of 2022. We have used these proceeds to reduce our debt balance from $150 million at the end of 2021 down to $57.5 million at the end of June 2022, with more reductions to follow. In parallel, cash burn remains top of mind, so I want to again highlight a figure that you can think of as a proxy for this metric. This figure is our cash flows from operating activities and continuing operations. This number excludes results from the Dunkirk sale, the Klasuri Ruralty sale, and the planned sale of the China API facility, which earned our second quarter results, is already reported under discontinued operations. For the second quarter of 2022, the cash dues was $18.3 million. This compares to the cash dues in the second quarter of 2021 of $34 million, which represents a year-over-year decrease of 46%. For the first half of 2022, cash dues totaled $36.8 million, or down 42% from the $63.8 million in the first half of 2021. Now let's review the second quarter financials. I would ask that you please refer to our press release that was issued earlier today for a full summary of our results, but I will highlight the following. Total revenues for the second quarter 2022 were $31.5 million, compared to $20.7 million for the same period in 2021. Product sale revenue increased by $5.4 million, or 26%, over second quarter 2021. R&D expenses totaled $13.1 million for the second quarter, a decrease of $7.6 million, or 37%, year over year, attributed primarily to a reduction in oral paclitaxel development costs, as well as other operational costs. SG&A expenses total $17.2 million for the second quarter, a decrease of half a million dollars, or 3%, as compared to $17.6 million for the prior year quarter, which was primarily related to decreased oral paclitaxel commercialization expenses. Net losses attributable to Athenix for the second quarter 2022 were $32.2 million, or $0.28 per diluted share, versus $34.3 million, or $0.33 per diluted share, in the second quarter of 2021. As of June 30, 2022, Athenax fed cash, cash equivalents, and restricted cash of $36 million. Finally, we are reiterating our guidance on our specialty pharma business to a growth of 20 to 25%. The strong performance in the first half of the year and our attractive pipeline of new launches, including M-Cure and Mila, give us confidence in this range. I will now turn the call back to Johnson for closing remarks.

Thank you, Joe, and thank you, everyone, for joining us today. This year, we're effectively executing the transformation of a Phoenix into a streamlined, pure-play cell therapy company with an extended cash runway. We continue to explore additional opportunities to monetize non-core assets and reduce operating expenses. We believe that our differentiated cell therapy programs have the potential to become market leaders and are poised to deliver shelter value, allowing us to further execute on our ultimate mission of bringing innovative treatments to cancer patients. I will now open the call for questions. I'll pray to you.

Thank you. We will now begin the question and answer session. To join the question queue, you may press star, then one on your telephone keypad. You will hear a tone acknowledging your request. If you are using a speakerphone, please pick up your handset before pressing any keys. To withdraw your question, please press star, then two. We will pause for a moment as callers join the queue. Our first question comes from Jonathan Chang of SVB Securities. Please go ahead.

Hi, everyone. Thanks for taking the question. This is Faisal. I'm for Jonathan. I just wanted to ask, could you provide some additional detail on the status of expanding the Anchor Study to multiple sites? And could you also provide some insight on what we can expect in the next update from that study? Thank you.

Sure. This is a cell therapy question. May I refer this to Dan, the president of our cell therapy group?

Sure. Thanks for the question. So as we have discussed before, we are in the process of expanding our current anchor study into a multi-center study. And our target is to expand it to 8 to 10 sites. Our current projection is that we are going to have an update on the Anchor Study either around ASH or our first quarter 2023. John?

Thank you for asking the question, and we are very excited with our data from the Anchor Study.

Our next question comes from Umar Rafat of Evercore.

Please go ahead.

Hi, guys. This is actually John Miller on. Let's start with, does the debt balance that you cited in your prepared remarks, like $57 million, include proceeds from the China API business that was at the end of the second quarter? And sort of relatedly, are you still planning on divesting the oral Paclitaxel programs, and will you wait for readouts or regulatory process to sell that, or can you give us some sense of what you're expectations are for that program.

With regard to your first question, yeah, Joe?

Yeah, with regards to the first question, and thank you for the question there, the 57.5 was at the end of the second quarter, so that does not include the sale or proceeds from the China sale.

With regard to your question, we consider right now we're trying to streamline the company into a pure play in sale therapy. So therefore, all non-core assets will be considered to be non-core. And for Oropec Taxol, we have the I-SPY2 data coming before the end of the year, in the second half of this year, which is in the next few months. We are trying to be opportunistic and try to unlock the value of our Oropec Taxol program. to fulfill our shareholders. But certainly, we are considering the oral pacotexel program to be non-core. So therefore, we'll try to monetize it as much as we can.

Great. That makes perfect sense. Maybe then on the cell therapy, can we talk a little bit about manufacturing for NKT cells, especially given lower dose that you're expecting to get compared to other cell therapies, which obviously this has been an issue for the industry in general? Are you going to be able to complete later stage development with your existing capacity, and can you talk about what your capacity needs are going to be, what you anticipate those capacity needs to be as you do late stage development for multiple programs and get towards commercialization?

Sure. Dan?

Thank you for the question, Jonathan. So, as a reminder, our NKT cells in the CURE 502 is the allogeneic approach. So, we're taking these NKT cells from healthy donors. And we have said and we continue to feel very confident that we can manufacture several hundred doses from one manufacturing run. So this really allows us to benefit from the economies of scale and have a much lower cost of goods compared to the current autologous CAR T. To answer questions directly on the capacity of manufacturing, we do not have, we don't see any constraints right now to get to that, you know, several hundred doses. There are certain things that we need to optimize on the manufacturing process. For example, closing some open steps into closed manufacturing steps, as well as working on automated fill and finish. But these NKT cells proliferate and expand incredibly well. The half time, the doubling time, I should say, is 24 to 36 hours. We believe that these NKT cells are going to be able to support not only the clinical study, you know, in the pivotal study, but as well as commercialization. And we'll continue to do more work to get to that point in terms of optimizing the process for manufacturing, as well as scaling up to several hundred doses. So that's work that is ongoing. Okay.

I'll also take this opportunity to ask our Chief Medical Officer of Cell Therapy, Daryl, to comment on his confidence level with regard to our current source of manufacturing in supporting all the clinical studies. Daryl?

Yeah, no, thanks, Johnson. Yeah, we are certainly well aware of the need to align our clinical development and our manufacturing capabilities as we move forward as fast as possible. Good news is that we are in close communications with our manufacturing facilities. They're aware of our clinical development plans, and we're aware of their manufacturing plans. And so far, we've not had any delays in either area due to a lack of coordination.

Our next question comes from Matt Kaplan of Ladenburg Thalmann.

Please go ahead.

Hi. Good morning, guys. Thanks for taking the questions. Just wanted to stay on the self-therapy programs. With 501, you mentioned continuing to enroll at higher dose levels. When do you expect to have some additional data on the higher dose levels? And then you also mentioned with respect to that program, thinking about registrational study decision, when should we have more visibility to moving into potential registrational studies for 501?

Thank you for your question. Daryl?

Yes, thank you for your question. Keep in mind, this is a single institution study of a very rare disease, so you might imagine enrollment is challenging, but it's progressing slowly but surely. With that as background, we're hopeful we can at least enroll the next dose level in the coming months and make a go-no-go decision shortly thereafter. The good news is we are learning a lot as we are proceeding, most notably that the CD62L-positive NKT cells are the ones that seem to be associated with response. Those, as Dan has mentioned previously, are associated with memory and persistence. They tend not to exhaust. And we're also learning that these cells are recruiting the host's endogenous response NKT cells and immune system, and they are indeed getting into the sites of disease. So every sign points to a positive forward decision, but we want to make sure we get to a dose that's going to cover the variety of patients with a variety of disease burdens moving forward. So again, we hope in the coming months we should be able to release more data and hopefully get to a go-no-go decision sometime next year.

Okay, that's helpful. And then with respect to Cure 503, where are you on the IND enabling studies there, and when should we expect that to move into the clinic?

Dave?

Sure. Hi, Matt. Thanks for the question. So for 503, we presented preclinical data on this new construct, which shows that the BATF3 transcription factor has very potent effect on the NKT cells in terms of anti-tumor activity as well as persistence, even better than IL-15. So we're working diligently to take this into an IND filing. We're doing a lot of the IND enabling studies right now, and we're currently targeting and filing the IND first half of 2023. and hopefully be able to enroll patients shortly thereafter. I'd also want to comment on your first question a little bit. Just as a reminder, in the GeneKit 2 study, we already have three out of 12 patients who have seen responses, and one of the responses in dose level 4 is a CR that persisted for about 12 months. So we have now two responses out of three patients at dose level 4. And that's very encouraging because the GD2 antibody that got approved also has about a 30% response rate with a median duration of about six months. So we believe that's a similar kind of pivotal study where they did 75 to 100 patient studies in a single arm. Pivotal study could potentially get regulatory approval. So we are seeing that kind of responses. We just want to make sure that we are optimizing the dose, and we look forward to, you know, being able to make a go-no-go decision when we have the data. Thank you, Matt.

Okay. Thanks. Thanks, Neha. Thanks for the added comment.

Once again, if you have a question, please press star, then 1.

Our next question comes from Yale Jen of Laidlaw & Co. Please go ahead.

Good morning, and thanks for taking the questions. My first question here is that what is the goal toward the end of the year in terms of your debt level reduction?

Okay, Joe.

Yeah, thank you for that question, Yao. As you can imagine, we look at this kind of on a case-by-case basis, so we're not targeting a specific goal per se, but let me answer your question more directly. So as you know, as you've been following us, we've been executing on a number of strategic transactions. As those transactions are announced, we'll discuss what the expected proceeds are, and as they draw to close, we'll work with our creditors on reducing the debt levels, but also continuing to fund R&D as we transition into the cell therapy business. So, we do look at it on – while we have an overall plan, we do look at and adjust that plan on a case-by-case basis as these transactions come to fruition.

Okay, that's very helpful.

Yeah, to add further into that is that As you understand that, I mean, we certainly would like to reduce at that level, working closely with our colleague in Oak Tree to achieve this objective. But at the same time, we need to make sure that the operation is smooth and then there's a lot of value to be extracted. The fact that the APD, APS business, they're growing at 20-25% and then the first year, the first half of the year was performing very well in some color with regard to the fact that there's a lot of intrinsic value. And I would like to answer your question further by asking Jeff to give a quick comment with regard to the current status with regard to this projection of the second half of the year. Jeff?

Jeff? Yes. The second half of the year, we are going to launch at least eight additional products we think some of these products are significant. They're high margin. We're going to be at market formation on half of them. The only reason we're being just a slight hesitant is that we expect on some of the big products that we just launched that there'll be additional generic competition. So we're anticipating very good growth in the second half and we'll revisit our our projections in terms of guidance at the end of the third quarter.

So we hope that we've answered your question from multiple angles. Yeah, thank you.

No problem. And actually, that was my second question, really, is that in the second quarter, the margin was roughly 10%, and you anticipate a potential margin expansion, and I assume that's because of the probably new products and maybe with higher margin. Am I correct in general in that regard? That's correct.

Yeah, correct. It's products at market formation, products that have bigger barriers to entry are part of it. We also anticipate some shortage products where the margins are significantly higher. So thanks for the question, Neil. No problem.

And maybe the last question here on 501. As you have the dose extension or the escalation, should we anticipate between the doses that you will have a break in terms of assessing the safety and others before you move to the next one, or you can do that more continuously?

Daryl?

Yeah, no, we can certainly do that continuously. I mean, the primary dose-limiting toxicity observation period is 28 days. Patients are being enrolled in sequential fashion. In general, we're monitoring that in real time as an open-label study in close connection with the investigator. So we should be able to make go-no-go decisions to the next dose level in real time as we've done previously.

Okay, great. That's very helpful. Again, thanks a lot. I appreciate it, and best of luck.

Thank you, yeah.

This concludes the question and answer session. I would like to turn the conference back over to Dr. Johnson Lau for any closing remarks.

Thank you, everyone, for joining us today. We'll continue executing on our transformation, and we'll provide you with another update next quarter. Thank you.

This concludes today's presentation. Thank you once again for your participation. You may