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spk03: Today's conference is scheduled to begin shortly. Please continue to stand by and thank you for your patience. THE END Thank you. Good day and thank you for standing by. Welcome to Horizon Therapeutics' first quarter 2022 earnings conference call. At this time, all participants are in a listen-only mode. After this week's presentation, there will be a question-and-answer session. To ask a question during the session, you'll need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to Tina Ventura, Senior Vice President, Chief Investor Relations Officer. Please go ahead.
spk07: Thank you, Norma. Good morning, everyone, and thank you for joining us. On the call with me today are Tim Walbert, Chairman, President, and Chief Executive Officer, Liz Thompson, Executive Vice President, Research and Development, Paul Holscher, Executive Vice President, Chief Financial Officer, Andy Pasternak, Executive Vice President, Chief Strategy Officer, and Erin Cox, Executive Vice President, Finance. As a reminder, Erin will be transitioning to the role of CFO on May 16th. Tim will provide a review of the business, including our first quarter performance. Liz will then review our R&D programs, followed by Paul, who will discuss our financial performance and guidance in more detail. After closing remarks from Tim, we'll take your questions. During today's call, we'll be making certain forward-looking statements, including statements about financial projections, development activities, our business strategy, and the expected timing and impact of future events. Our actual results could differ materially due to a number of factors, including the risk factors and other information outlined in our latest Forms 10-K, 10-Q, and any 8-Ks filed with the Securities and Exchange Commission, and our earnings press release, which we issued this morning. Your caution not to place undue reliance on these forward-looking statements, and Horizon disclaims any obligation to update such statements. In addition, on today's conference call, non-GAAP financial measures will be used. These non-GAAP financial measures are reconciled with the comparable GAAP financial measures in our earnings press release and other filings from today that are available on our investor website at www.horizontherapeutics.com.
spk01: I will now turn the call over to Tim. Thank you, Tina, and good morning, everyone. We had a strong start to the year with first quarter net sales of $885 million and first quarter adjusted EBITDA of $371 million. We also reiterated our full year 2022 guidance this morning and are well-positioned for another year of top-tier growth. In addition to strong financial and operational performance, we made meaningful progress on our strategic priorities. We continue to advance our pipeline, initiating two of the seven clinical trials expected to start this year. We also advanced our DASA DALABAP clinical programs, announcing positive top-line results for our Phase II trial in rheumatoid arthritis, and completing enrollment in our phase two trial in Sjogren's syndrome. The positive readout from our RA study serves as an important proof of concept validating the DASA-DALABET mechanism of action, as well as providing further validation of our acquisition of the yellow last year. We look forward to the readout of the phase two trial in Sjogren's syndrome next year. With Cristexa, we're pleased to be granted FDA priority review of our supplemental biologics license application for Cristexa plus methotrexate. This marks an important milestone in establishing Cristexa plus immunomodulation as a standard of care. We're also making progress in our global expansion strategy. We recently received approval for a in Europe for NMOSD, and we're initiating its European launch starting with Germany. We also initiated the build out of our infrastructure in Brazil, to support the potential launches of Aplizna and Tepeza. As we continue to advance our strategy to drive rapid growth over the coming years, we announced today that we have hired Jacopo Leonardi as President, Global Commercial Operations, reporting to me. Jac is an accomplished life science executive with more than two decades of commercial experience, including driving growth of high performing businesses in rare diseases and immunology. YACC will oversee the U.S. and international commercial organizations, commercial development, and global medical affairs. Finally, we continue to receive recognition as the best workplace, including ranking in Fortune's 100 Best Companies to Work For for the second consecutive year and retaining the highest ranked position in the biotechnology pharmaceutical category. This recognition underscores the strong engagement of our employees, which is very important in our highly competitive industry. Before I move on to our results in the quarter, I want to thank Paul Holscher for his contributions that he's made to Horizon during his time here. As many of you know, Paul is retiring this month. He has been a tremendous partner over his nearly eight years with us, and I'm grateful for his leadership and dedication to Horizon, as well as his financial stewardship that has contributed significantly to our success and transformation during that time. We're pleased that Paul will be staying on an advisory role through May of next year to ensure a smooth transition. As announced previously, Aaron Cox will assume the CFO role on May 16th. Moving on to our growth drivers. Tepeza first quarter net sales of $501 million were in line with our expectations. As we mentioned last quarter, the Omnicon variant had an impact on our business beginning at the end of last year, as did typical seasonality. Despite that, we generated strong performance in the quarter. As we discussed last quarter, we continue to drive the next stage of our commercial strategy. This includes more deeply penetrating our high-priority TED physician targets. Additionally, we are broadening our reach to general ophthalmologists and endocrinologists in order to further educate them on thyroid eye disease and accelerate the referral of their patients to TED treaters. As part of our plan, we're increasing our field force to accelerate referrals to existing treaters and expand the number of physicians prescribing Tepeza, as well as continuing our significant investment in direct-to-consumer and other key digital activities. We expect these activities to accelerate growth as we move further throughout the year. Reaffirming our confidence in achieving our strong growth expectations for Tepeza this year, despite Omnicon-replated impacts, persisting into the second quarter. The TED market has evolved considerably in the last two years since the approval of TPEZA, which has proved to be a paradigm-shifting medicine. As the TED market leader, we have continued to do a significant amount of work to further inform our understanding of the market. This includes additional market analysis, payer claims analysis, physician and patient market segmentation, and commercial strategy work. which all support the growth of TPEZA over the long term. Initial readouts from this have been very insightful and positive. First, we have continued to validate the size of the U.S. TED market and believe it is at least as large as what we have communicated in the past, if not larger. This gives us even greater confidence in the long-term potential for TPEZA and our global peak annual net sales expectation of more than $3.5 billion globally. Second, it is providing us with important information about the patient journey, and therefore how we can further drive execution over the short and long term. We are finding that patient symptoms, such as diplopia and pain, regardless of the time from diagnosis, are what drive them to seek treatment and drive physicians to prescribe Tepeza. In contrary to earlier views suggesting the majority of TED patients experience less severe symptoms over time, we now know that there's a significant cohort of patients who experience high inflammation and high proptosis more than two years after diagnosis. In fact, most of the chronic patients being treated with Tepeza today have high levels of inflammation along with their proptosis. When you launch a transformative medicine into a market that has never had an adequate treatment, the treatment of the disease is continually being redefined. We see symptoms versus time from diagnosis as the key driver of patient uptake. As you've seen in our DTC commercials and other digital activities, we're expanding our messaging to cover a broader set of signs and symptoms beyond proptosis. Symptoms such as diplopia, eye mobility, eyelid retraction, orbital pain, and swelling around the eye. We see significant potential to access many more patients with thyroid eye disease who are appropriate for Topeza. For Cristexa, first quarter net sales were $141 million, representing year-over-year growth of 32%. We generated strong performance despite the impact of the Omicron variant. This was driven by continued adoption in both rheumatology and nephrology market segments, as well as uptake of Cristexa plus immunomodulation which is now running at approximately 50% of new patients. This is up from 35% just a year ago, and remarkable considering the MIRA data is not currently available for promotion by our commercial organization. We expect the rate of immunomodulation use to continue to increase over time. We're preparing for the July 7th PDUFA Action Day to modify the Cristexa label with the results of the MIRA trial. which demonstrated 71% of patients who received Cristexa plus methotrexate achieved a complete response, more than 30 percentage point improvement compared to placebo patients who received Cristexa alone. With an expanded label, our commercial team would, for the first time, be able to actively promote the benefits to physicians. We expect this to drive higher clinical conviction, broadening our reach to more physicians and deepening our penetration among current treating physicians. This will help to address the significant ongoing unmet need for more than 100,000 patients living with the debilitating effects of uncontrolled count. The team is preparing for the potential approval and will be ready to launch a new promotional campaign in early July. Additionally, our clinical team continues to work on MIRA data dissemination at medical meetings and throughout key publications. We'll be conducting peer-to-peer education programs to continue to build a broader understanding of the MIRA clinical data. We're also very pleased that the MIRA trial was accepted as an oral presentation at the upcoming European Rheumatology Medical Conference, or ULAR, in June. We've been significantly investing in Cristexa to change its perception since we acquired it in 2016. Rarely, if ever, has a company been able to completely transform the profile of a 12-year-old medicine as we have with Cristexa. And we're now incredibly proud to be at this next step in its transformation to bring the medicine to so many more patients, which gives us increased confidence in our peak annual net sales expectation of more than $1 billion. Moving on to APLISNA, which we began the relaunch in the fourth quarter of last year. We delivered another strong quarter, generating first quarter net sales of $31 million. Approximately $5 million is international revenue from our international partners. We continue to make good progress with our relaunch, expanding the prescriber base and driving new patient starts. In the first quarter, more than half of the patient enrollment forms are generated by new prescribers, building a foundation for long-term growth. While the majority of new patients are switching from other therapies, which is in line with our commercial strategy, we're also seeing a good portion of new patients that are naive to therapy. This speaks to the confidence physicians have in UPLISA as a next-generation B-cell depleting therapy. We continue to see faster and higher patient pull-through, driven by the strong support provided by our patient services, reimbursement, and site-of-care teams. which is a critical component of the APLISNA relaunch. On the clinical side, we continue to invest in medical and scientific engagement to drive patient and physician preference for APLISNA based on its strong clinical data, its differentiated mechanism of action, and clear patient benefits. We significantly expanded peer-to-peer speaker programs with more programs held in the first quarter than all of last year. In addition, we presented new data at several key medical meetings, continuing to build on its long-term safety and efficacy data. As part of our global expansion strategy, we will be launching APLISNA in Europe, starting with Germany, following the recent European Commission approval. We are increasingly confident in the prospects for APLISNA in animalicity, as well as in other indications we are pursuing, for the medicine and are progressing towards our peak global annual net sales expectation of more than $1 billion across all indications. I will now turn the call over to Liz.
spk06: Thank you, Tim, and good morning, everyone. On this call a year ago, we shared that we'd completed the Viela acquisition and were in the process of integrating the two companies. We've come a long way since then and have a busy year ahead as we continue to drive our pipeline forward. This morning, I'll update you on the progress of our key programs, starting with our TPEZA trial in chronic thyroid eye disease. We're continuing to enroll patients in our phase four randomized placebo-controlled trial in chronic TED. The results of this trial will add to the emerging literature studying TPEZA in patients with chronic TED. We now expect the top-line data readout for this trial in the first half of 2023. This is somewhat later than we had originally expected, and is due to a slower level of patient enrollment, which is primarily due to the impact from the Omicron variant. We've since put in place a number of measures that are helping drive enrollment, and we're tracking to a top-line readout in the first half of next year. We continue to advance our TAPASA subcutaneous administration program, where we're on track to begin enrolling TED patients in a Phase 1b trial mid-year. and we continue to progress our work on our high-concentration formulation. We also continue to enroll patients in the OpticJ study in Japan. We remain focused on developing scientific leadership in TED through attendance at key medical meetings during the year, including endocrinology, ophthalmology, oculoplastic, and optometry conferences. In the second quarter alone, we plan to attend seven key medical meetings. Moving to dextilamab, or HCN7734, the first and only plasmacytoid dendritic cell, or PDC, depleter in clinical development. PDCs are found in high concentrations in diseased tissues of individuals with certain autoimmune and inflammatory diseases, and the activity of these cells can result in significant inflammation and tissue damage. The Phase II trial for our first potential indication for dextilamab in systemic lupus erythematosus, or SLE, continues to enroll, and we continue to expect results for this trial in 2023. We expect to begin clinical trials in four additional indications this year. The first, alopecia areata, is an autoimmune disorder characterized by non-scarring hair loss. As we discussed in significant detail on our last earnings call, we remain on track to initiate this Phase II open-label trial in the second quarter, in approximately 30 patients with moderate to severe disease. We expect to initiate our discoid lupus erythematosus, or DLE, trial midyear. DLE is a chronic inflammatory skin condition characterized by lesions. It's a scarifying disease that can be significantly disfiguring and can also result in hair loss. One of the mischaracterizations of DLE is that it only affects systemic lupus patients. However, 80% of DLE patients do not have systemic disease and therefore have primary DLE. We estimate about 30,000 patients with DLE are candidates for novel therapies, including biologics. The current standard of care is not uniformly effective and is associated with potential side effects. Our DLE clinical trial will be a Phase II randomized placebo-controlled trial in patients with moderate to severe active primary disease. The primary endpoint will be the mean change in the CLAWSI-A disease severity score from baseline to week 24. We will also be looking at a variety of other measures of disease activity. We also expect to initiate our trials in lupus nephritis and dermatomyositis later this year. Moving on to Dazidalibap or HCN4920, this is our CD40 ligand antagonist designed to block a central pathway involved in many autoimmune and inflammatory diseases. We recently completed enrollment in the Phase II double-blind placebo-controlled trial evaluating dazadalibep for Sjogren's syndrome, a chronic systemic autoimmune condition that impacts exocrine glands, including the salivary and tear glands. We expect results in 2023. Yesterday, we also announced top-line results from our Phase II double-blind, placebo-controlled trial of Dazidalibep in rheumatoid arthritis patients, demonstrating that the primary endpoint was met in all four Dazidalibep dosing arms and showing that Dazidalibep was well-tolerated. We expect to present the full results at an upcoming medical congress. This marks the first of what we hope will be many clinical validations of the value we saw in the VLF pipeline. As a reminder, Our rheumatoid arthritis trial gives us the opportunity to accelerate our learning about Dazidelibep in a large and reasonably accessible patient population using well-understood clinical endpoints. This trial reinforced our understanding of the CD40 ligand pathway in immune-mediated and autoimmune diseases and provides us with important insights as we consider dosing regimens for future trials in Sjogren's syndrome and the progressive and rare kidney disease FSGFs. We expect to initiate our Dazidelibap trial in FSGS in the fourth quarter. Moving to HCN825, our oral selective Lpar1 antagonist, which has shown early signs of clinical impact in fibrotic disease. We enrolled our first patient in our pivotal Phase IIb trial for HCN825 in idiopathic pulmonary fibrosis in January of this year. This trial was and our trial in diffuse cutaneous systemic sclerosis continue to enroll. Aplizna is our anti-CD19 humanized monoclonal antibody indicated for NMOSD, a rare and devastating neuroinflammatory autoimmune disease that attacks the optic nerve, spinal cord, and brain stem. As Tim mentioned, the European Commission recently approved Aplizna for the treatment of adult patients with NMOSD who are AQP4 autoantibody positive. This is a great accomplishment for the R&D team, but an even more important step in our efforts to bring a new option to people impacted by this disease. We also continue to contribute to the literature regarding the efficacy and safety profile of Aplizna. Most recently, in April, multiple new data from the Phase III trial were presented at the American Academy of Neurology meeting. The new data demonstrated that there were no significant differences in attacks, or worsening of the expanded disability status scale between NMOSD patients treated with apluzna who had experienced one pre-study attack and those who had experienced two or more pre-study attacks. A separate new analysis of the Phase III trial showed that long-term treatment with apluzna improved pain and quality of life outcomes for at least three years. We continue to advance our enrollment in our two Phase III clinical trials evaluating neplizna for myasthenia gravis and IgG4-related disease. Finally, as Tim mentioned, July 7th is the PDUFA action date for the SBLA that supports updating the Cristexa label to include co-administration with methotrexate. Data from the MIRA randomized controlled trial will be presented at ULAR in early June, where all of our Cristexa and gout-related abstracts were accepted. We also hope to share additional details from the MERA trial at other key medical meetings. And I will now turn the call over to Paul.
spk00: Thanks, Liz. My comments this morning will primarily focus on our non-GAAP results unless otherwise noted. I'll start with our first quarter results followed by our 2022 financial guidance. First quarter net sales were $885 million in line with our expectations. Our orphan segment generated first quarter sales of $834 million, driven by the strong performance across the portfolio. Our orphan segment operating income was $352 million. Net sales for the inflammation segment were $51 million, and segment operating income was $15 million. Our non-GAAP first quarter gross profit ratio was 88.9% of net sales. First quarter non-GAAP operating expenses were $420 million. This included non-GAAP R&D expense of $92 million, where we continue to invest in multiple clinical trials, many that we are initiating this year. Non-GAAP SG&A expense was $328 million. First quarter adjusted EBITDA was $371 million, or 41.9% of net sales. The non-GAAP tax rate for the first quarter was 10.2%. Non-GAAP net income in the quarter was $316 million, and non-GAAP diluted earnings per share were $1.34. The weighted average shares outstanding used to calculate first quarter 2022 non-GAAP diluted EPS were 236 million shares. First quarter non-GAAP operating cash flow was $223 million. As of March 31st, Cash and cash equivalents were $1.64 billion. Backed by this strong cash position and expected future cash flows, business development will continue to play a critical role in expanding our pipeline. The total principal amount of our outstanding debt is $2.6 billion, with the earliest maturity in 2026. Our gross debt to last 12 months adjusted EBITDA leverage ratio is 1.6 times as of March 31st. Additionally, in March, Moody's upgraded our corporate family rating to BA1 from BA2. And I'll turn to our outlook for 2022 and how we see the rest of the year playing out. We are maintaining our full year 2022 net sales guidance of $3.9 to $4 billion, representing year-over-year growth of 22% at the midpoint. For Tepeza, we expect full year 2022 net sales percentage growth in the mid-30s. For Cristexa, we expect full year 2022 net sales growth of more than 20%. We continue to expect full year 2022 gross margin of approximately 87%. We expect full year adjusted EBITDA to be between $1.63 and $1.7 billion, representing a 42.1% margin at the midpoint a 230 basis point expansion compared to 2021. Our adjusted EBITDA guidance reflects our expectations for strong sales growth, partially offset by our increased investment in R&D, which we expect to be in the low double digits as a percentage of net sales. As we think about our 2022 operating expenses, we expect a steady increase over the course of the year, mainly driven by R&D. As it relates to our debt interest expense, we recently entered into an interest rate swap to move $800 million of our floating rate debt to a fixed interest rate. Given the expected rising interest rate environment, our new fixed versus floating debt mix, along with our significant cash balance, positions us well to manage expected increases in interest rates. As a result of the swap transaction, $1.4 billion, or 54% of our gross debt outstanding as fixed interest rates, which will provide more certainty to our interest expense over the next several years. We now expect our full-year non-GAAP net interest expense to be approximately $85 to $90 million, a modest increase from our prior expectations of $80 to $85 million. We continue to expect our full-year 2022 non-GAAP tax rate to approach 12%. As with every year, we anticipate variability in our non-GAAP tax rate on a quarterly basis. We continue to estimate that our 2022 cash tax rate will be in the mid to high single digits. As always, our tax rates could change significantly as a result of any acquisitions or divestitures we may make or any changes in tax laws. We continue to expect our full year 2022 weighted average diluted share count to be approximately 238 million shares. Finally, as Tim mentioned, Aaron Cox will assume the role of CFO when I retire in a couple weeks, and I look forward to staying involved with Horizon in an advisory role for another year. I want to take this opportunity to say thank you. I've enjoyed the opportunity to work with all of you in the investment community during my time at Horizon. I also want to thank Tim and the Horizon team for the opportunity to have been part of the incredible growth of Horizon over the past eight years. With that, I'll turn the call over to Tim for his concluding remarks.
spk01: Thanks, Paul. I also want to thank you again for your many years of service and partnership contributing to our tremendous success and transformation. It's pretty amazing to look back on the day you started with us eight years ago, almost today, and three medicines, I think no rare disease medicines in a market cap of about a billion dollars, and We've had an incredible transformation since the period you joined, and you were certainly a critical part of that. And we appreciate everything you've done and appreciate that you continue to be available and consulting and working with us. So thanks so much, Paul. Really appreciate that. In closing, we generated strong financial results for the quarter, positioning ourselves for another year of top-tier growth. We made meaningful progress on our strategic priorities, including initiating two of the seven clinical trials planned this year, as well as advancing our Dazadelidip program in two indications, evidence of our effort to aggressively maximize our pipeline. The positive readout of our Dazadelidip study in rheumatoid arthritis is an important proof of concept, validating the Dazadelidip mechanism of action, as well as providing further validation of the acquisition of VLF. We look forward to many more with multiple trial readouts as we move into 2023. We're significantly preparing for the potential Christexa SBLA approval in July, after which we plan to launch a new promotional campaign to drive the use of Christexa plus methotrexate. And our international expansion efforts are taking shape in support of recent and future approvals, such as the announcement for the EC approval this week. We're off to a good start, and I look forward to continuing to deliver progress on our pipeline and our strong commercial execution as we build on this foundation and drive increasing value to shareholders. With that, Tina, why don't we turn it over to questions?
spk07: Yes, Norma, please go ahead.
spk03: Thank you. As a reminder, to ask a question, you'll need to press star 1 on your telephone. To withdraw your question, please press the pound key. Please stand by while we compile the Q&A roster. Our first question comes from Chris Schott with J.P. Morgan. Your line is now open.
spk02: Great. Thanks so much for the questions. I said two on Tepeza. I guess first a bigger picture one. Given the supply disruption last year, I think it's been harder for the street to get a clean look at kind of what's happening with underlying growth with Tepeza. So just it sounds like you've done some incremental work on the market. Can you just maybe frame for us right now your penetration rate currently into the acute market and what you see as the primary hurdle for patients who aren't getting therapy that you need to address to get them on therapy. So that's a bigger picture one. And the second one I was looking for is just color on sequential dynamics to keep in mind for TPEZA and 2Q. I think in the prepared remarks, you mentioned you're still seeing some Omicron impact, which surprised me a bit. We'd appreciate a little more color there. Thanks so much.
spk01: Sure, Chris. Certainly with the PESA from within a few weeks of launch in early 2020, the world changed, the pandemic began, and we had two years of a non-normal launch sequence. So certainly there has not been a normal distribution, a normal launch. We had the supply issue, as you talked about, and we had the Delta variant in the third quarter and play the most invasive variant with the Omicron variant in 2020. really from mid-December through February. So when we look at our penetration, we feel that we've had very strong penetration of the acute market, but with significant upside opportunity just based on the numbers. We are, I don't know exactly what numbers we've communicated, but I would say roughly minimal penetration relative to the full opportunity in the incident acute market. When we look at the prevalent chronic population, we continue to make strides there. We've got mid-teens, as we discussed last quarter. So I think we're set up really well for growth. And as I mentioned in my remarks, while we've had a lot of atypical situations with Omicron and the pandemic, as well as the supply disruption, We have had tremendous uptake, and we are continuing to learn more and more about the patients. And I talked about in my remarks that we're seeing symptoms being a much more important impact alongside of just proptosis. So we're seeing that significant opportunity to expand to broader patient populations, so proptosis plus key symptoms, and also use that as a pathway to bring patients in who are sitting in ophthalmologists, endocrinologists, or just sitting at home. So our DTC efforts, a lot of that, our expanded sales force, as we discussed, is all about driving further referrals and driving further penetration and getting physicians and patients to the right TED treaters. So I think we're making good progress with significant continued upside. On the sequential dynamics, we talked about this, again, on the last quarter when we We looked at, during that December to February period, over half of our commercial organization itself was out with Omicron. We had physicians' offices closed, sites of care closed. We had many patients, and I would say that the first quarter impact for infused medicines like Tepes and Crostex was around patients missing infusions, extending infusions, and then we worked through the first quarter to get people back on track, and we were able to successfully do that. Any impacts on PEPs, And that Omicron period, when you have a PEP to IV rate of 90 days, that is a 90-day delay. So anything we've ever done since launch is set up as a 90-day delay, given the average time it takes for a patient enrollment form to convert to infusions. So coming out of Omicron, so coming out of that December to February period, we saw a nice recovery in trends. We were able to engage in more face-to-face interactions. So those live calls that are such a key driver of performance, significantly started to increase in March. Getting back out to medical conferences, sites of care have gotten back to normal levels in seeing patients. But that Omicron lag effect is what drives that delay into the second quarter that we mentioned. And we do expect to present that sales to be more heavily weighted in the back half of the year as a result. But really excited about what we do is deal with these situations we have throughout the pandemic and and drive the business.
spk07: Thanks, Chris. Norma, next question, please.
spk03: Thank you. Our next question comes from Madhu Kumar with Goldman Sachs. Your line is now open.
spk04: Yeah, thanks for taking our questions. I guess our first one is kind of digging a little more into the DASA-DALA depth results in RA and how to think about the kind of dosing implications for some of the other indications. You obviously kind of already kind of completed enrollment in Sjogren's, but thinking more around FSGS, what does the DAS data already teach you that could be informative for the FSGS trial? Liz?
spk06: Yeah, thanks for that. So, you know, we were pleased to see these data. It really represents our proof of concept for the DAS develop mechanism of action, which was great. It's the first of what I hope will be many clinical validations of that value that we saw in the VL pipeline. We did see here positive top line results. the dosing arms and also what appears to be so far an acceptable safety profile. I think that the value of this trial in addition to those pieces is exactly as you say, this is an accessible patient population that lets us look at a variety of doses and regimens that we can then take those learnings and apply them to future trials that we might take things forward and that is particularly applicable for future studies in Sjogren's that we might do, as well as FSGS. We'll be talking in more detail about these results at upcoming medical meetings, including a little bit more insight into the specifics of the regimens we looked at and the results we got. But overall, we think this really will set us up for success in picking the right doses to take forward and other indications.
spk07: Thanks, Madhu.
spk06: Norma, next question, please. Okay.
spk07: Next question, Norma? Madhu, are you still on? Norma, next question, please. Norma, we can't hear you. Yes, but it sounds like everybody else can. Norma's lost audio. We just learned that Norma's lost audio. So let us see if we can hold and see if we can try to dial back in.
spk05: Thank you.
spk07: Norma?
spk03: Our next question comes from Yaken Suneja with Guggenheim. Your line is now open.
spk07: Sorry about that, everybody. Thank you for your patience.
spk05: Thank you.
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