HUTCHMED H1 2026 Earnings Call Transcript

Key Takeaways

  • Positive Sentiment: Oncology revenue rose 23% to $162 million in the first half of 2026, supported by strong China sales of ELUNATE and SULANDA and 40% growth in FRUZAQLA global in-market sales. Management maintained its full-year revenue guidance.
  • Positive Sentiment: FRUZAQLA’s ex-U.S. geographic expansion drove particularly strong momentum, with sales up 70% outside the U.S.; management expects further growth as additional countries launch the product and secure reimbursement.
  • Positive Sentiment: The company reported $16 million of net income and a substantial cash reserve of $1.4 billion, while reiterating its commitment to remain broadly breakeven or profitable as it increases investment in growth programs.
  • Positive Sentiment: HUTCHMED advanced its pipeline, with two ATTC assets in global Phase I trials and a third cleared for clinical development. Key savolitinib readouts from the global SAFFRON and China SANOVO studies are expected in the second half, while ATTC clinical data are anticipated in 2027.
  • Negative Sentiment: R&D spending increased to $79 million from $72 million as the company invested in ATTC trials, discovery capabilities and AI. Its non-core, low-margin Other Ventures distribution business declined by nearly 20% on a constant-currency basis, partly due to expanded Chinese volume-based procurement.
AI Generated. May Contain Errors.
Earnings Conference Call
HUTCHMED H1 2026
00:00 / 00:00

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David Ng
David Ng
Head of Investor Relations and Capital Strategies at HUTCHMED

Welcome, everyone. Thank you for joining HUTCHMED 2026 Interim Results announcement and presentation. Before we start, I would just like to go over the safe harbors statement and disclaimer on page two. The performance and results of operation of HUTCHMED Group contained within this presentation are historical in nature, and past performance is no guarantee of future results. Next, I would like to invite our Acting CEO and CFO, Johnny Cheng, to start the opening. Johnny?

Johnny Cheng
Johnny Cheng
Acting CEO and CFO at HUTCHMED

Thank you, David, and welcome everyone again joining our interim results webcast tonight. Together with me, we have our Deputy CFO, Lorenso Chiu, also our George Yuan, Head of Commercial, and also our Dr. Dai, Head of Discovery and Global Portfolio Management. All of us will be sharing with you our first half results and outlook. On page four, as you can all see, we have achieved a lot in the first half. China product sales have very strong results, especially ELUNATE and SULANDA, which grew by over 40%. FRUZAQLA global in-market sales were strong. Ex-U.S. markets were up 70% after rapid geographic expansion.

Johnny Cheng
Johnny Cheng
Acting CEO and CFO at HUTCHMED

On the bottom left, we have received two approved label expansions, Fruquintinib for RCC and savolitinib for GC. In addition, we have three NDAs in China under priority review. On the top right, our next wave of innovation focuses on ATTCs. We have two first-in-class assets which have entered the phase I clinical trials. A third asset, HMPL-A830, has cleared its IND and will be entering the clinic in the second half. At the same time, the global SAFFRON study and the China SANOVO study will have their data readouts in the second half. I will now hand it over to Lorenso Chiu, our Deputy CFO, to discuss our financial results.

Lorenso Chiu
Lorenso Chiu
Deputy CFO at HUTCHMED

Thank you, Johnny. On slide number six, I'd like to give more details of our financials for the first half of 2026. First of all, our oncology revenue was $162 million, including $121 million products revenue. This represent an about 23% growth over the first half of 2025. Johnny already mentioned our China product sales have shown a very good performance in the first half. I'd like to highlight that ex-China demand for FRUZAQLA continues to grow as well, achieving an overall 40% growth in in-market sales. With this first half result, our full-year guidance remains in the range of $330 million to $415 million. Altogether with other ventures revenue, the total group revenue amounted to $278 million. Next, please. On R&D expenses, which amounted to $79 million for the first half, compared to $72 million for the first half of 2025.

Lorenso Chiu
Lorenso Chiu
Deputy CFO at HUTCHMED

The increase reflects on one thing, we initiate the global phase I trials of our ATTC assets, including 251 and 580. In addition, we increase our investments in our discovery capabilities, including our talents and AI. On the bottom line, we continue to be profitable with net income of $16 million. It is important to note in last years, we have included a $460 million SHPL divestment gain, and also the share of the post divestments, about $21 million. With this strong operating results and cash flows, we continue to have a very good cash reserve of $1.4 billion. Now I'd like to hand over to Mr. George, our Head of Commercial, to give an update of our China commercial.

George Yuan
George Yuan
Head of Commercial at HUTCHMED

Thanks, Lorenso. As Johnny mentioned, global geographic expansion continue to drive our FRUZAQLA growth. If we look at the first half, we see a 70% growth in the geography outside the U.S., which is very strong. If you look at the Q2, the growth rate actually accelerate to 27%. We still believe that there still has opportunity to get more country get launched and also go into the reimbursement. Takeda already confirmed the fiscal year guidance of a 25% growth. Next slides. If we look at China, we have a very robust growth for ELUNATE. We are in a highly competitive market. If we look at the first half, we are growth at 41%, and the current NRDL renewal bring us a continuous growth opportunity with the second-line mCRC included. We synchronize our mCRC reimbursement scope with our label.

George Yuan
George Yuan
Head of Commercial at HUTCHMED

The NRDL renewal actually provide us a unique opportunity for future growth, we keep our price flat. Second-line RCC get approval in May 26, this provides us another opportunity to apply for NRDL this year. Based on IQVIA hospital audit and our ATU study, ELUNATE continue to be a market leader in third-line mCRC. Next slides. Beyond FRUZAQLA and ELUNATE, we also have a strong performance on ORPATHYS and SULANDA. ORPATHYS, we are target to include such indication in this year NRDL, renew by end of this year, we get approval third-line MET-amplified GC. In the coming months, we are looking at SAFFRON and SANOVO readout. For SULANDA, we have strong growth in first half based on the highly recommend by CSCO guideline for the NET.

George Yuan
George Yuan
Head of Commercial at HUTCHMED

The CSCO guideline change the recommendation about the SSA. The SSA, dose escalation will not be recommend after the disease progression. This growth is a result our focus strategy focus on top-tier city and the top hospitals. Next slides. Looking to the future, Sovleplenib, our Syk inhibitor, will bring us into the hematology immunology fields. This is the first-in-class medicine, and it can help patients to transform their treatment in both ITP and wAIHA.

George Yuan
George Yuan
Head of Commercial at HUTCHMED

If we look at the ITP in China, we have 360,000 patients, and the current treatment, TPO, steroids, still cannot meet the medical needs of those patients. With this product, we provide a very unique value for those patients for long-term, stable, predictable disease control. Also for wAIHA, which is a relatively small indication, but it's under critical needs for new medicine. We will be the first target therapy after 30 years in the field. We will significantly reduce blood infusion for those patients. Now, I will hand over to our R&D, Dr. Dai.

Guangxiu Dai
Guangxiu Dai
Head of Discovery and Global Portfolio Management at HUTCHMED

Thank you, George. Now, let's transition into our R&D updates. Over the next few slides, I'll share how our late-stage clinical programs are progressing toward key commercial approvals and how our innovative platform is unlocking brand-new opportunities to address major unmet medical needs. Next slide, please. Looking at our recent achievements, we've hit several critical milestones across both solid tumors and hematology. Our novel ATTC platforms represent a huge strategic growth driver for us globally. The early biological profiles of ATTCs gives us high confidence in their ability to target major solid tumors and differentiate from other ATTC products. We've officially taken the first two ATTCs into the clinic, A251 and A580, initiating global phase I trials. The third ATTC, A830, recently cleared the IND in both the U.S. and in China. We secured approval for Fruquintinib in Renal Cell Carcinoma in June 2026.

Guangxiu Dai
Guangxiu Dai
Head of Discovery and Global Portfolio Management at HUTCHMED

This is another important approval for Fruquintinib after CRC and in mCRC. With surufatinib, we have kept momentum strong with our phase III trial in first-line PDAC fully on track, addressing an aggressive cancer type with very few viable options. Savolitinib, our second inhibitor, is making rapid progress on lung cancer autoimmune indications. The NDAs for ITP and wAIHA are currently under priority review. These mark huge steps towards establishing a new, highly effective standard of care in these conditions. The pivotal phase III data of ESLIM-02 was recently presented at EHA this year. Savolitinib expanded its commercial footprint with the third-line gastric cancer approval. This is the fourth regulatory approval for savolitinib after previous lung cancer approvals. 760, our potent PI3K/BTK inhibitor, successfully initiated its phase III trial in second-line DLBCL. Fanregratinib reached a pivotal moment with its NDA acceptance for FGFR positive intrahepatic cholangiocarcinoma.

Guangxiu Dai
Guangxiu Dai
Head of Discovery and Global Portfolio Management at HUTCHMED

The data was featured at ESMO GI this year. Together, these achievements reflect a highly efficient R&D engine, strengthening our commercial presence today while laying the foundation for our global ATTC platform tomorrow. Next slide. Let's dive a bit deeper into our individual core assets, starting with savolitinib, our second potential global commercial product. Savolitinib targets lung cancer driven by MET alterations, which remains an area of significant unmet medical need. We are fast approaching several important milestones. In the second half of this year, we expect data readouts from two key studies, SAFFRON on a global scale and SANOVO in China. SAFFRON is our global registration phase III trial. It targets second-line patients with EGFR mutant non-small cell lung cancer who developed MET amplification or overexpression after progressing on TAGRISSO. Currently, these patients are on heavy chemotherapy.

Guangxiu Dai
Guangxiu Dai
Head of Discovery and Global Portfolio Management at HUTCHMED

SAFFRON directly compares our oral combination of savolitinib plus TAGRISSO against double chemotherapy. When approved, this trial will replace chemotherapy with an oral target option and opening access to major markets like the U.S. and Europe. SANOVO targets the first line setting. We know that a significant subset of lung cancer patients present with coexisting EGFR mutations and MET overexpression right at initial diagnosis. SANOVO evaluates combining savolitinib with TAGRISSO directly upfront versus TAGRISSO alone. By attacking both targets from day one, our goal is to deliver deeper response and prevent resistance from emerging. Together with our proven phase III SACHI data, which showed a dramatic hazard ratio of 0.32 in PFS over chemotherapy, these upcoming readouts from SAFFRON and SANOVO position savolitinib to capture leadership across the entire treatment paradigm in MET-driven lung cancer. Next slide.

Guangxiu Dai
Guangxiu Dai
Head of Discovery and Global Portfolio Management at HUTCHMED

This slide highlights Sovleplenib, which is spearheading our next wave of hematology and autoimmune products. wAIHA is a deliberating disease where red blood cells are destroyed prematurely, leaving patients severely anemic and often they rely on high-dose steroids and frequent blood transfusions. In our phase III ESLIM-02 study presented at EHA, Sovleplenib achieved a 66% durable response rate compared to 15% in the placebo group. Patients on Sovleplenib reached target hemoglobin levels in a median of 3.1 weeks, twice as fast as the placebo. Substantial drop in rescue therapy and transfusion. Only 16% of Sovleplenib patients require rescue therapy, compared to 54% on the placebo. Red blood cells transfusions were significantly reduced to just 11% versus 43% in the control group, allowing the patients to taper or completely discontinue their baseline steroids.

Guangxiu Dai
Guangxiu Dai
Head of Discovery and Global Portfolio Management at HUTCHMED

When you compare this to the emerging peer options like nipocalimab, Sovleplenib shows a clear competitive efficacy advantage, delivering a much higher durable response rate, without forcing patients to stay on a chronic high risk immunosuppressants. We are eager to bring Sovleplenib to a patient population that hasn't seen a new target therapy option in 30 years, and currently, the NDA is under priority review. In ITP, what sets Sovleplenib apart from standard care agents like TPOs and TPO-RAs is exceptional efficacy without associated thrombotic complication warnings found on their peer labels. In ITP, Sovleplenib achieved a striking durable response rate compared to placebo, even though 75% of the enrolled patients had failed prior TPO therapies. ESLIM-01 study is also under priority review in China. Next slide.

Guangxiu Dai
Guangxiu Dai
Head of Discovery and Global Portfolio Management at HUTCHMED

Turning to slide 17, let's look at 760, our highly potent selective and reversible BTK inhibitor characterized by long target engagement. Currently, this is the only BTK inhibitor in late-stage clinical development targeting the second line DLBCL all comers. Our phase II study showed encouraging response rate, PFS, and safety profile. Our phase III registration study in China is actively ongoing, comparing 760 in combination with R-GemOx against the placebo plus R-GemOx, with primary endpoints of PFS and OS. We expect to complete enrollment by the end of 2027. Next slide, please. Here, I want to highlight our novel ATTC platform, starting with A251. ADCs, like in HER2, have transformed HER2-positive cancer treatment, generating billions in revenue. However, acquired resistance to DXd, the cytotoxic payload used in HER2, remains a major clinical hurdle as patients inevitably progress.

Guangxiu Dai
Guangxiu Dai
Head of Discovery and Global Portfolio Management at HUTCHMED

The DXd induced in resistant model on the bottom show that in HER2 loses potency almost completely, shifting the curve far to the right. In the same resistant cell model, because A251 utilizes completely distinct mechanisms targeting the PI3K and PIKK signaling pathways rather than DNA-damaging toxins. Its killing activity in DXd-resistant cells, shown in the green curve, remains identical to DXd-sensitive parent cells, shown in the blue curve. Next slide. Beyond treating drug-resistant tumors, A251 has strong potential as a frontline treatment, as shown in this gynecological cancer and GI cancer xenograft models. Combining A251 with the first-line standard of care yields significant tumor volume reduction compared to either therapy alone.

Guangxiu Dai
Guangxiu Dai
Head of Discovery and Global Portfolio Management at HUTCHMED

Crucially, this synergistic effect does not come at the cost of added toxicity, proving A251 can safely be combined, which is what we aim to achieve with ATTCs in the first place, which is better efficacy and better safety. Our clinical strategy is twofold. A monotherapy track for a fast-to-market approach in late-line setting, and a combination track targeting frontline indications. Our extensive pre-clinical data support the A251 development strategy. The clinical trial is on track at dose escalation stage. Next slide. Our second ATTC asset is 580, which pairs the same payload with an EGFR targeting antibody. Blockbuster drugs like TAGRISSO treat EGFR mutant non-small cell lung cancer, but resistance eventually develops.

Guangxiu Dai
Guangxiu Dai
Head of Discovery and Global Portfolio Management at HUTCHMED

In a non-small cell lung cancer model carrying the challenging EGFR exon 19 deletion and the resistant mutation, third generation TKIs like TAGRISSO completely lose control of tumor growth, as shown by the red curve. 580, represented by the blue curve, achieved profound and sustained tumor regression as a single agent. This highlights its enormous potential for lung cancer patients. Next slide. By combining 580 with an EGFR inhibitor, we can simultaneously shut down primary receptor signaling and the downstream escape pathways. The pre-clinical data reflects a highly significant synergistic anti-tumor efficacy, supporting our long-term plan to move this asset into frontline cancer regimens. This global asset entered phase I trial earlier this year. The trial is going very well, recruiting patients from China sites and the U.S. sites in parallel. Next slide. What makes our ATTC platform so unique is the payload itself.

Guangxiu Dai
Guangxiu Dai
Head of Discovery and Global Portfolio Management at HUTCHMED

Historically, the industry has struggled with pan-pathways, pan-PI3K or dual PI3K inhibitors. Small molecules were simply too toxic to be delivered systemically, resulting in severe side effects like hyperglycemia or mucositis. Single node inhibitors were safer, but their efficacy was limited. Our innovation was to design a highly selective payload that harvests multiple key nodes along both the PI3K and PIKK pathways with very high affinity, and then tether it to an antibody. This ensures the payload is delivered inside the tumor cells, maximizing intracellular kinase inhibition while sparing healthy tissues from systemic toxicities. The kinase tree on the right illustrates this high selectivity of the payload. Next slide. The ATTC approach opens up massive opportunities.

Guangxiu Dai
Guangxiu Dai
Head of Discovery and Global Portfolio Management at HUTCHMED

The pan-pathway is the single most frequently altered pathway across all solid tumors. It plays a dominant role in breast cancer, lung cancer, gastric and ovarian cancers. By effectively targeting this pathway with our ATTC technology, we can potentially reach millions of patients across a wide range of cancer types. Next slide. With A251 and 580 currently in global trials, A830 entering the clinic soon, and more candidates behind them, our pipeline is well-positioned to deliver a sustained growth for years to come. Thank you. I'll give it back to Johnny.

Johnny Cheng
Johnny Cheng
Acting CEO and CFO at HUTCHMED

Thank you, Dr. Dai. A quick highlight on our outlook. On the innovation side, as mentioned by Dr. Dai, multiple ATTC programs are progressing well, and we believe around this time next year, there should be a total of five programs already in clinics. More importantly, our efforts in AI will be transforming and accelerating further discovery and development in our innovation platform. On the commercial side, we expect FRUZAQLA's sales growth to continue. We anticipate it will reach its next sales milestone in the near term. Regarding our hematology portfolio, our commercial team is preparing for the launch of our immunology asset, which is anticipated to commence next year. Finally, we are continuing to engage many multinational companies on collaboration discussion regarding our ATTC program. I will now pass it back to David to begin our Q&A session.

David Ng
David Ng
Head of Investor Relations and Capital Strategies at HUTCHMED

Thank you, Johnny. We will now start our Q&A session. Before we start, I would like to repeat the instructions to ask question. On the bottom of your screen, you can see the Raise Hand button. Just press on that button. We will call out your name and unmute your line. When you start, please do mention the name of your company as well as your name. The first question comes from Matthew of CLSA. Matthew, you can now go ahead and talk. Thanks.

Analyst at CLSA

Hi, thank you for taking my question. This is Matthew from CLSA. I have three questions. First is regarding the collaboration opportunities for the ATTC programs, two in clinic and one about to be in clinic. Could you elaborate more on the kind of progress, because I think that there's been some expectation of the maybe early-stage collaboration before. Yeah, can you comment on that? Second one is regarding your HMPL-760, the BTK inhibitor. Yeah, as you mentioned, you have got initiate the phase III trial for DLBCL in China.

Analyst at CLSA

May I understand how is this drug different from other BTK inhibitors, and why would you choose the DLBCL to proceed for phase III, as there are no other BTK inhibitors approved for these indications, including the covalent ones and also the non-covalent ones are non-approved. The third question is regarding on the financial side. I know that the Other Ventures is a low-margin distribution business, but may I still have some color on why in the first half is on a constant exchange rate basis declined by almost 20%? Okay, that's my questions. Thank you.

Johnny Cheng
Johnny Cheng
Acting CEO and CFO at HUTCHMED

Thank you, Matthew. I will invite Dr. Dai to answer the second question, and Lorenso to answer the last question. The first question regarding the collaboration opportunity, basically, we are continuing, and we have active multinational companies engaging in discussion with us on not just one program, but multiple ATTC program. As you know that our programs are still at the very early stage, so different expectation in terms of timeline and information to be provided from our side to the collaborate potential partners.

Johnny Cheng
Johnny Cheng
Acting CEO and CFO at HUTCHMED

They have kind of different requirements. All I can say right now it is we are in active discussions with multiple parties, and the discussions are progressing well. When I think the discussions is coming to a close to mature and is disclosable items, then we will be making an announcement to the public. Maybe Dr. Dai, you can answer the question number two regarding the 760 BTK.

Guangxiu Dai
Guangxiu Dai
Head of Discovery and Global Portfolio Management at HUTCHMED

Sure. Johnny. Yes, we have actually started phase III study, with HMPL-760. It is a combination of HMPL-760+ R-GemOx versus R-GemOx. We pick DLBCL, obviously, because it is the largest lymphoma subtype, accounting for about 40% of lymphoma. No other BTK inhibitors has been approved for this particular subtype of lymphoma. It represents a huge unmet medical need and good market potential. With our HMPL-760, it is reversible BTK inhibitor, and in earlier clinical study, it demonstrated a very good selectivity and safety profile.

Guangxiu Dai
Guangxiu Dai
Head of Discovery and Global Portfolio Management at HUTCHMED

We actually had a phase II study validating its efficacy in the second-line setting. It is the same study design, and we achieved a very impressive overall response rate and the CR rate, and a very favorable safety profile to encourage us to go into the phase III study. It is a very exciting opportunity for HMPL-760, and we hope to achieve the enrollment completion as fast as we can. Thank you.

Lorenso Chiu
Lorenso Chiu
Deputy CFO at HUTCHMED

Yep. Johnny, I will answer question three. As for the Other Ventures, I think you are right to point out that our Other Ventures is a low-margin business, which is not our focus. We are putting our focus on our major oncology revenues. As you can see, the growth is there. That is the reason that there was some decline in the Other Ventures business. I do not think we need to look into too much about behind this, because, as you said, it is low margin and it is not our core.

Johnny Cheng
Johnny Cheng
Acting CEO and CFO at HUTCHMED

Maybe I just supplement that. I think as highlighted by Lorenso, this is not our core business. It is basically, it is a logistic distribution business. The reason there has been some decline is because of the volume-based procurement list has actually in China have been expanded. Some of the previously our customers in the logistic distribution side have actually affected by the volume-based procurement, in terms of their selling price and so forth. That services business is not what we focus, basically because of the high working capital requirement for this business. As a way to manage this business, we try to just maintain this line of business to help to gain insights into the commercial channel in Shanghai. I think that the drop, it does not actually affect the bottom line. It does not affect in terms of the entire business operation of HUTCHMED.

Analyst at CLSA

Okay, that's very clear. Thank you very much.

David Ng
David Ng
Head of Investor Relations and Capital Strategies at HUTCHMED

Thank you, Matthew. Thank you, Johnny. The next question is from Chen Chen of UBS. Chen Chen, we will now open up your line. Your line is now unmute.

Chen Chen
Chen Chen
Executive Director and Head of China Healthcare at UBS

Sure. Thank you for taking my questions. My first question is on Sovleplenib. This candidate is expected to receive approval next year. Could you please elaborate on your commercial preparation strategy in China, including pricing, marketing access, and NRDL, and your sales force? In addition, what are your overseas R&D plans and priorities for this asset? My second question is on ATTC. What is the expected timeline for clinical data readout from your candidate one and two? Thank you.

David Ng
David Ng
Head of Investor Relations and Capital Strategies at HUTCHMED

Thank you. May I ask George to answer the first question and Dr. Dai do a second question?

George Yuan
George Yuan
Head of Commercial at HUTCHMED

Thanks, Chen Chen. For Sovleplenib launch preparation, we are focused on few area. First thing is market access, value proposition. We need to make sure this product's going to the NRDL, and we expect this product to get approval maybe in the first half next year and qualify for the NRDL negotiation. One of the challenges is how can we position us very well to achieve affordable and realistic price in this disease. One of the understanding is we will do a kind of HE data based on our clinical trial.

George Yuan
George Yuan
Head of Commercial at HUTCHMED

On the other side, we also would like to work with a patient group, with opinion leaders, to understand the pain points of the current treatment and try to make sure we really leverage those patient insights to make sure the government understand there's a main needs and there's a quality of life, a kind of compromising for those patients who receive other treatments. This will help us to leverage the future.

George Yuan
George Yuan
Head of Commercial at HUTCHMED

On the other side, we definitely will do the guideline, we do the KOL, as well as a physician education program, also a patient advocacy group as well. If you look at the current setup for the launch, we have already built up a dedicated hematology team with a lot of experienced people in the hematology side. We are starting to work with our partners to understand the market potential, try to figure out what's our first wave target hospitals, territories, and the resource deployment.

Guangxiu Dai
Guangxiu Dai
Head of Discovery and Global Portfolio Management at HUTCHMED

I'll get the second question. The first and second ATTC assets are both in the middle of phase I dose escalation. The trials are moving very fast. Enrollment has been going strong in the U.S. and in China sites. Investigators are very excited about the novel mechanisms and the differentiation. They understand the rationale, and they are enthusiastic about the new mechanism of the ATTCs. We will find the right time to disclose the clinical data sometime in 2027. Thank you.

Chen Chen
Chen Chen
Executive Director and Head of China Healthcare at UBS

Got it. Thanks, George and Dr. Dai.

Guangxiu Dai
Guangxiu Dai
Head of Discovery and Global Portfolio Management at HUTCHMED

Thank you.

David Ng
David Ng
Head of Investor Relations and Capital Strategies at HUTCHMED

Thank you, Chen Chen. The next question comes from Paul Choi of Goldman Sachs. Go ahead.

Paul Choi
Paul Choi
Biotechnology Analyst at Goldman Sachs

Hi, can you hear me?

David Ng
David Ng
Head of Investor Relations and Capital Strategies at HUTCHMED

Yes, we can. Thanks.

Paul Choi
Paul Choi
Biotechnology Analyst at Goldman Sachs

Hi. Thank you. Good morning, good evening. I want to talk a little bit about first ask on Sovleplenib as you sort of look at the warm autoimmune hemolytic anemia landscape, just sort of the other products or candidates that are in that category, how do you think about potential developments and planning for a global trial outside of China? Just sort of any additional thoughts on what aspects or differentiation are needed there? I had a follow-up question.

Johnny Cheng
Johnny Cheng
Acting CEO and CFO at HUTCHMED

Dr. Dai? Yeah.

Guangxiu Dai
Guangxiu Dai
Head of Discovery and Global Portfolio Management at HUTCHMED

Of course.

Johnny Cheng
Johnny Cheng
Acting CEO and CFO at HUTCHMED

George, yeah.

Guangxiu Dai
Guangxiu Dai
Head of Discovery and Global Portfolio Management at HUTCHMED

HMPL-523, now both studies in ITP and wAIHA were completed in China. We are waiting for CDE's feedback on our NDA data. In ex-China, our strategy is to develop this asset through partnership.

Paul Choi
Paul Choi
Biotechnology Analyst at Goldman Sachs

Thank you. Any thoughts on, again, sort of what clinical differentiation might be needed versus development strategy?

Guangxiu Dai
Guangxiu Dai
Head of Discovery and Global Portfolio Management at HUTCHMED

Right now, the treatment paradigm, for example, for wAIHA, the first-line is mainly the steroids, like George mentioned earlier. We are targeting the second-line patients, which doesn't have a lot of choices other than the steroids. The unmet medical need is very high in China as well as in the U.S. As you can tell from our phase III data, the overall durable response rate looks very promising compared to the other competitors, which is FcRn antibody product. We think this asset has great potential, so we are actively looking for partnership to co-develop this asset outside the China.

George Yuan
George Yuan
Head of Commercial at HUTCHMED

Yeah, maybe I can add because this wAIHA is regarded as a rare disease, and we also have a plan to apply U.S. orphan drug status.

Paul Choi
Paul Choi
Biotechnology Analyst at Goldman Sachs

Okay, great. Thanks for that clarification. My second question is on HMPL-453 fanregratinib. You advanced it through the second line ICC population on the oncology side. I want to ask what your thoughts are on potential endocrinology applications such as achondroplasia and other bone growth disorders, and if you think this might be a potentially appropriate candidate there. Thank you.

Guangxiu Dai
Guangxiu Dai
Head of Discovery and Global Portfolio Management at HUTCHMED

With HMPL-453, our main focus right now is intrahepatic cholangiocarcinoma, second line. We have started the confirmatory trial to get this indication confirmed in the same setting. Thank you.

Paul Choi
Paul Choi
Biotechnology Analyst at Goldman Sachs

Thank you.

David Ng
David Ng
Head of Investor Relations and Capital Strategies at HUTCHMED

Thank you, Paul. The next question comes from Adam McCarter of Cavendish. Adam, your line is now unmuted.

Adam McCarter
Equity Research Associate Director of Healthcare at Cavendish

Hi there. Yeah, thanks for taking the questions. A couple of questions from me just on the commercial portfolio. Obviously it was encouraging to see the recovery across ELUNATE and SULANDA. Just on ORPATHYS, you did highlight the opportunity for NRDL inclusion following the SACHI based approval. I am just wondering how significant do you think that could be commercially? Do you expect that to be a key driver of a recovery in China sales, or is the more meaningful inflection point still this de novo readout and the opportunity to further broaden adoption? That is my first question.

Johnny Cheng
Johnny Cheng
Acting CEO and CFO at HUTCHMED

George, you would like to answer that one?

George Yuan
George Yuan
Head of Commercial at HUTCHMED

Yeah. I think the SACHI inclusion in the NRDL will significantly improve the growth potential for the brand. Because if we look at the data, if you look at the EGFR-resistant patients, there are quite significant amount of patients with MET amplification. So far, there is no other choice. The bispecific monoclonal antibody in China is not included in the NRDL from Johnson & Johnson. We still have a growth potential. Also, this combination will extend the TAGRISSO treatment duration as well, and as well as kind of levers for AstraZeneca to compete with other TKIs. That is why we believe that this is a strong growth potential. Having said that, also one of the hurdle is that we still need a secondary biopsy, so there is a kind of adoption at practice in the medical side.

Adam McCarter
Equity Research Associate Director of Healthcare at Cavendish

That's great. Thanks very much for clarifying. My second question, again, on the commercial side of things is for FRUZAQLA. Just wondering how we should think about the growth trajectory for U.S. sales going forward. Should we now be thinking about a period of steadier growth with ex-U.S. markets becoming an increasingly more important contributor to incremental growth for the brand?

Johnny Cheng
Johnny Cheng
Acting CEO and CFO at HUTCHMED

Okay, maybe I'll just comment on this one. I think for FRUZAQLA, for the last year almost, I think there was some Medicare impact in terms of the gross to net. As you can see, the growth momentum is through the geographic expansion of the ex-U.S. markets in the first half especially. We have looked at 70% growth there. Also, I think one point to note is although the geographic has expanded, the NRDL in those market is only 50% so far. We believe there will still be a lot of opportunity for ex-U.S. Earlier, we have also shared with all of you that from our information from Takeda, that they expect U.S. side, basically, the size of U.S. peak sales versus the rest of the world will be kind of a 50/50 ratio. We believe there's still a lot of growth momentum behind this global sales of FRUZAQLA.

Adam McCarter
Equity Research Associate Director of Healthcare at Cavendish

Great. Thank you. If I could chance maybe a final question, just on, obviously, reiterate the guidance. Could you just help us try and understand the key drivers that determine whether the business lands towards the lower or the upper end of the range? In other words, should we primarily be thinking about the contribution from milestones, continued recovery of the China portfolio, or ongoing growth in ex-China for FRUZAQLA revenues? Thank you.

Johnny Cheng
Johnny Cheng
Acting CEO and CFO at HUTCHMED

Well, I think, as you can note that in the first half, the guidance for this year is actually $330 million to $415 million. With our base line achievement, it is without any business development contribution in there. We will be at least beating the lower end of the guidance. With certain potential partnering, which we recognize some upfront income, that we can reach higher or even exceeding the high end of the guidance. That is the range.

Johnny Cheng
Johnny Cheng
Acting CEO and CFO at HUTCHMED

Also other factor that can affect the second half is, as we mentioned, FRUZAQLA, that we do anticipate that it will reach another level of sales milestone that would contribute, again, some one-time commercial milestone income that would also help us to meeting or even exceeding our target that we have given out to the market. We are quite confident that we will be able to achieve this guidance that we have given out to the market earlier.

Adam McCarter
Equity Research Associate Director of Healthcare at Cavendish

Great, thank you very much for answering my questions.

David Ng
David Ng
Head of Investor Relations and Capital Strategies at HUTCHMED

Thank you, Adam. Just to repeat the instruction, if you have any question, do press the raise hand button at the bottom of your screen. The next question comes from Julie Simmonds of Panmure. Julie.

Julie Simmonds
Julie Simmonds
Managing Director at Panmure

Thank you for taking the question. Thank you.

David Ng
David Ng
Head of Investor Relations and Capital Strategies at HUTCHMED

Thank you.

Julie Simmonds
Julie Simmonds
Managing Director at Panmure

Julie Simmonds from Panmure Liberum. Just again, on the milestones. There was a milestone in the first half from Takeda. I was just wondering what that related to. Then beyond the sales milestones to which you just referred, are there any other milestones anticipated? I was wondering if there was anything due from Astra on the SAFFRON trial readout.

Johnny Cheng
Johnny Cheng
Acting CEO and CFO at HUTCHMED

No. Actually, in the first half, just to clarify, it was from the approval of the RCC Renal Cell Carcinoma, so it was from Eli Lilly. Yeah. In terms of our second half, besides the sales milestone, so far we do not expect any other milestones from our partners yet. In terms of if we achieve good results for our Sovleplenib, we will be receiving milestones more likely next year, not this year.

Julie Simmonds
Julie Simmonds
Managing Director at Panmure

Lovely, thank you very much. Just as far as sort of the overall margins are concerned, you've done slightly better, I think, probably in terms of sort of balance between sales and spending than maybe I'd thought you might do. Is the aim to continue to remain, to try to continue to be broadly breakeven to slightly profitable going forwards in your sort of thinking of how the business is going and using the cash in potential business development activities?

Johnny Cheng
Johnny Cheng
Acting CEO and CFO at HUTCHMED

Yes, definitely. I think it is a strong commitment, requirement by our board that we will continue to be breakeven. That's a commitment that we made a couple of years back. This is a strong commitment from all our management team. This is not going to be changing. Of course, we will balance with investment in area definitely that would drive growth and creating value for the shareholders. That's why we're accelerating ATTC program. At the same time, of course, we are exploring business development opportunity with our partners so that we can basically creating, accelerating our ATTC innovation opportunity.

Julie Simmonds
Julie Simmonds
Managing Director at Panmure

Lovely. Thank you.

David Ng
David Ng
Head of Investor Relations and Capital Strategies at HUTCHMED

Thank you, Julie. Again, if there's any question, please do press the raise hand button. At this moment, I don't see any further question online. Johnny, would you like to make a concluding remark?

Johnny Cheng
Johnny Cheng
Acting CEO and CFO at HUTCHMED

Yes. I thank you everyone for joining this interim results. We look forward to meeting again, I think, in later on. We will be planning for a R&D day sometime later this year. We will make relevant announcement in due course. Thank you.

David Ng
David Ng
Head of Investor Relations and Capital Strategies at HUTCHMED

Thank you, everyone. This conclude our interim result presentation. Thank you. Bye-bye.

Johnny Cheng
Johnny Cheng
Acting CEO and CFO at HUTCHMED

Bye-bye.

Executives
    • David Ng
      David Ng
      Head of Investor Relations and Capital Strategies
    • Johnny Cheng
      Johnny Cheng
      Acting CEO and CFO
    • Lorenso Chiu
      Lorenso Chiu
      Deputy CFO
    • George Yuan
      George Yuan
      Head of Commercial
    • Guangxiu Dai
      Guangxiu Dai
      Head of Discovery and Global Portfolio Management
Analysts
    • Analyst at CLSA
    • Chen Chen
      Executive Director and Head of China Healthcare at UBS
    • Paul Choi
      Biotechnology Analyst at Goldman Sachs
    • Adam McCarter
      Equity Research Associate Director of Healthcare at Cavendish
    • Julie Simmonds
      Managing Director at Panmure