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spk08: Greetings and welcome to the Arena Pharmaceuticals Inc. fourth quarter and 2022 earnings call. At this time, all participants are on a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Jamie Harrell, Investor Relations for Arena Pharmaceuticals. Thank you. You may begin.
spk03: Thank you, Operator, and thank you all for joining today's call and webcast to discuss ARENIA's fourth quarter and full year 2022 financial and operational results. Joining me this morning are Peter Greenleaf, Chief Executive Officer, and Joe Miller, Chief Financial Officer. This morning, ARENIA issued a press release announcing its final audited financial results for the fourth quarter and full year ending December 31, 2022, as well as its recent operational highlights. In addition, the company filed its annual financial statements on Form 10-K. For more information, please refer to Arrhenius' filings with the U.S. Securities and Exchange Commission, which are also available on Arrhenius' website at arrheniapharma.com. During this call, ARINIA may make forward-looking statements based on current expectations. These forward-looking statements are subject to a number of significant risks and uncertainties, and actual results may differ materially. For discussions of factors that could affect ARINIA's future financial results and businesses, please refer to the disclosures in ARINIA's press release and its annual financial statements on Form 10-K, along with all of the recent filings with the U.S. Securities and Exchange Commission and Canadian security authorities. Please note that all statements made during today's call are as current of today, February 28, 2023, unless otherwise noted and are based upon information currently available to us at this time. Except as required by law, Arinia assumes no obligation to update any such statements. Now let me turn the call over to Arinia's President and CEO, Peter Greenleaf. Peter?
spk06: Well, thanks, Jamie, and good morning, everyone. Let me first thank you all for joining us on the call today. As you may have noticed, we issued preliminary unaudited fourth quarter and year end numbers in early January. So on this call today, we're going to provide you with the final audited results for the fourth quarter and year end 2022. In addition to the quarterly and year end financials, we'll provide you with an update to our ongoing commercialization activities with a strong focus on the progress we've made through the first couple months of this year. We'll also provide you with an update on our efforts in the XUS markets, cover off on the advancement of our pipeline, and then provide a brief recap on the IP front for Luke Kynas. After this overview, I'll then turn the call over to Joe Miller to provide additional details on the financial results. So let's get started with our 2022 business performance. For the full year, Irinia achieved $134 million in total net revenue. which represented a 194% increase over 2021. We achieved $103.5 million in net product revenue, representing 120% increase over the previous period. For the fourth quarter 2022, we achieved a $28.4 million in total net revenue and a $28.3 million in net product revenue, representing a 21% increase over the fourth quarter. Moving to more detail behind our financial results. During the fourth quarter, Arinia added 406 patient start forms, or PSFs. This represented a 9% increase over the 374 patient start forms that we added in the third quarter of this year. For the full year, we added a total of 1,648 PSFs. And it's important to note that the growth in PSFs was significant in the months of November and December. This momentum was achieved during the months with shorter weeks due to holidays, and we believe shows how the work we initiated in the third quarter is starting to pay off. We also monitor our conversion rates from patient start forms to patients on therapy as well. The amount of time that it takes to ship drugs to patients. I'm pleased to report that we continue to improve our PSF conversion to patients on therapy, reflecting more than 85% of PSFs being converted to shipped on drug. We are now also improving the time it takes to get patients on therapy. In the fourth quarter, we increased our processing speed at all time periods, 30, 60, and 90 days. with approximately 60% of our patients getting on therapy in 20 days or less. I want to note that this is meaningful improvement over the first 18 months of the launch. Our 12-month persistency remains at approximately 50%, but when we look out past one year to 15 months, we're encouraged to see almost 45% of patients remaining on therapy. Consistent with prior periods, adherence to treatment regimen remains strong at approximately 80% at year end. Exiting 2022, a total of 1,525 patients were on therapy. This is an increase of greater than 75% versus 2021 and an improvement of approximately 13% over Q3. The increase in patients on therapy in the last quarter was driven predominantly by improvements in new PSFs, conversion rates, and processing speeds. Our net realizable revenue per patient for loop kinase remains higher than our initial guidance of 65,000 per patient per year. But as we discussed previously, we expect to approach this figure on an annualized basis as more patients go on and stay on therapy over time and as persistency, dosing and payer mix evolve. Every quarter since the initial launch, this number has ranged closer and closer to our annualized estimate. As we've said in the past, the biggest driver of this estimate is dose adjusting and persistency, and I underscore not significant payer access discounts driving margin erosion. Moving to the tactical actions that we initiated in the third quarter. We launched a new marketing campaign to healthcare professionals, emphasizing improved clinical outcomes with Leukinus when compared to the historical standard of care. More specifically, we are educating physicians on the efficacy of Leukinus, its more complete response rates, including speed and durability, as well as the ability to rapidly reduce steroids. And lastly, we're emphasizing Leukinus' efficacy in minority patient populations, which represent the majority of SLE and lupus nephritis patients. Our customer-facing teams in the field are focused on clinical differentiation and delivering the lupkinus clinical story toward the highest targeted potential writers. Our activity against these targets has steadily increased throughout the quarter and into the new year. In addition, in the back half of the year, we increased initiatives focused on patient education and building awareness. In Q3, we launched a new consumer campaign focused on both disease awareness and patient activation, with the goal being to motivate the patient to seek urinalysis and treatment, and of course, when doing so, reinforcing the benefits of treatment with lupkinis. There's room for importance in screening for proteinuria during SLE patient visits. A recent 2019 Optum Healthcare study, which was compiled of 100 million electronic health records from about 150,000 SLE patients, revealed that approximately 50% did not receive urine screening for lupus nephritis. The guidelines across multiple bodies drive urine screening at every visit as a treatment goal. If every SLE patient receives a urinalysis screen during their regular visits, we would identify more lupus nephritis and do it earlier in the disease progression. This represents a big opportunity for better patient management and, of course, the potential for more disease diagnosis. Lastly, we identified and contracted with a nationally recognized spokesperson to further raise awareness around lupus nephritis and its consequences. While we're not actually talking about the details of this partnership today, We look forward to updating you more on this exciting partnership as we get closer to its launch. While much of our marketing approach is designed to increase the depth and frequency of prescribing among our existing physician base, we continuously work to ensure that all patients and prescribers have a good experience with accessing the product. Our RNA Alliance patient support team continues to make the process of product acquisition as seamless as possible for every patient and their provider. The impact of this group's work is evidenced by the increased speed of starting patients on therapy, as well as improved retention and adherence rates. In the fourth quarter, our team spent significant amount of time working with patients and caregivers on the transition into 2023. Many times, year-over-year insurance plan changes, policy changes, and patient co-pay resets can interrupt patient therapy in the first quarter of the following year. We put significant work against this to help ensure continuity of care moving into 2023. In addition to our commercial execution, it's important to note that our medical team's efforts related to loop kindness are crucial to driving education awareness, and overall adoption. Over the past few quarters, we've generated significant visibility with healthcare providers with a substantial in-person presence through one-on-one conversations with physicians in both their offices and all major medical conferences. During 2022, we developed and presented sub-analyses of data from both the Aurora I and Aurora II Extension Study to further the clinical understanding of lupus nephritis and our drug's impact on the disease. Again this year, we plan to submit or have already submitted data for abstract and podium presentations at all major medical conferences. Our medical team continues to be a critical part of our overall education efforts. We continue to build on the momentum we established in the fourth quarter with daily prescription trends improving quarter over quarter. As of February 24th, we have added an additional 274 PSFs, bringing our total PSFs since launch to approximately 3,500. Based on everything discussed, we are reaffirming our net product revenue guidance for this year of $120 to $140 million. In 2022, we achieved significant milestones on loop kindness in the global markets. As a reminder, we partnered with Atsuka to commercialize loop kindness in certain European countries and Japan. This collaboration agreement spans clinical, regulatory, commercial, and manufacturing, all in a milestone-driven, royalty-based, and cost-plus arrangement. In the fourth quarter, we received a $30 million milestone payment related to the marketing authorization for Loop Kindness in the European Union. Additionally, the UK's MHRA granted approval in Great Britain in November of 2023. Atsuka has also submitted an MAA filing to Swiss Medic, which is currently under review with approval expected in the first half of 2023. When we receive pricing and reimbursement approval in three of the five major countries in the EU, this will trigger an additional $10 million milestone from Otsuka. Currently, we expect this milestone in late 2023. We anticipate first commercial sales in Europe during the first half of this year. Moving to Japan, our efforts to gain regulatory approval remain on track. We currently expect a PMDA submission in mid-2023. Upon approval, we would be eligible for an additional $10 million milestone payment from Otsuka and then low double-digit royalties on net sales. While we have issued press releases throughout January on this topic, shifting gears, I'd like to provide you with a brief recap on our recent progress on the intellectual property front covering Lucanus. To start, we reached a settlement with Sun Pharmaceuticals resulting in part in the termination of the inter partes review of our 036 method of use patent by the US Patent Office. As a reminder, that patent has a term extending to December 2037. As we've stated previously, the terms of this settlement remain confidential, though as we've noted, both parties agreed to dismiss their claims and counterclaims and cease to bring any further action against each other. We've also received a notice of allowance from the U.S. Patent and Trademark Office for our patent application relating to an improved treatment protocol of lupus nephritis with our product Lupkinus, further strengthening our patent position with more specific language associated with our unique dosing regimen. We would be seeking to have that patent listed in the orange book once issued. And this patent, once granted, would also have a term extending to December 2037. And then finally, we recently received a notice of intention to grant from the European Patent Office for a patent application with similar claims to our 036 Method of Use patent, which, once this is granted, would provide additional IP protection in the European Union. Obviously, these are important milestones in the continued development of our IP as a company. Shifting gears to the ongoing clinical work for loop kinase, it remains on track. This includes the advancement of both the vocal pediatric study and the Enlight LN registry. With the registry, we now have 44 activated sites with 45 patients enrolled. Our plan is to leverage real-world data collected from this study to gain further knowledge about patients taking lupkinase and to help clinicians and payers improve the overall patient care of patients suffering from lupus nephritis. Throughout 2023, we look forward to updating you on the progress of our research pipeline. As of now, we continue to advance the IND enabling work for both AUR200 and AUR300. Our aim is to submit an IND for AUR 200 by the end of 2023, and an IND for AUR 300 in 2024. We ended 2022 with a strong balance sheet, and we intend to continue to prioritize and focus our investments towards commercialization, with the growth of Loop Kindness being our primary priority, and of course, the development of our emerging pipelines. So with all of that, let me now turn the call over to Joe Miller for a more detailed review of our financial results, and then I'll return at the end of the call for a quick recap and to open up the line for any questions you might have. Joe?
spk05: Thank you, Peter, and good morning, everyone. At December 31st, 2022, we had cash, cash equivalents, restricted cash investments of $389.4 million compared to $466.1 million in the prior year. The decrease in cash, cash equivalents, restricted cash, and investments is primarily related to the continued investment in commercialization activities, advancement of our pipeline, and a payment for the achievement of a one-time milestone, partially offset by an increase in cash receipts from the Sale of Loop Kindness and the milestone payment received from Otsuka in 2022 related to the EC marketing authorization. We believe that we have sufficient financial resources to fund our current operations, which include funding commercial activities, including FDA-related post-approval commitments, manufacturing and packaging of commercial drug supply, funding our supporting commercial infrastructure, advancing our research and development programs, and funding our working capital obligations for at least the next few years. Now let's take a few minutes and go into detail regarding our financial results for the quarter and year end of December 31, 2022. Total net revenue increased 21% to $28.4 million for the fourth quarter compared to the prior year period. Total net revenue for the year increased 194% to $134 million compared to the prior year period. The increase in both periods are due to an increase in product sales, driven predominantly by further penetration into the LN market, as evidenced by the increase in patients on therapy year over year. The increase for the full year of 2022 also includes the recognition of a $30 million milestone payment from Otsuka, as Peter mentioned earlier. Total cost of sales and operating expenses for the fourth quarters of 2022 and 2021 was $56.5 million and $56.1 million respectively. Total cost of sales and operating expenses for the full year periods were $245.5 million and $226.3 million respectively. Now let me give you a further breakdown of OPEX drivers and fluctuations. Cost of sales were $1.4 million and $481,000 for the fourth quarters of 2022 and 2021 respectively. Costs of sales were $5.7 million and $1.1 million for the full-year periods. The increase for both periods was primarily due to an increase in product-related revenue, changes in patient mix, coupled with an increase in inventory reserves related to process validation batches used for FDA approval. Gross margin for the fourth quarters of 2022 and 2021 was approximately 95% and 98%, respectively. Gross margin for the full-year periods was approximately 96% and 98%, respectively. Selling general and administrative expenses inclusive of share-based compensation were $47.5 million and $44.8 million for the fourth quarters of 2022 and 2021. For the full-year periods, SG&A expenses inclusive of share-based compensation were $196.4 million and $173.5 million. The primary drivers for the increase for both periods were increased professional fees and services, mainly related to corporate legal matters and pharmacovigilance, an increase in travel costs in a COVID-endemic environment, as well as an increased participation in trade shows, medical conferences, and sponsorship to support the commercialization of Loop Kindness. Additionally, salaries, incentive pay, and employee benefits increased due to employee promotions and inflationary impacts. Non-cash SG&A share-based compensation was $7 million and $7.2 million for the fourth quarters of 2022 and 2021, respectively. For the full-year period, non-cash share-based compensation expense was $28.4 million and $26.4 million, respectively. Research and development expenses inclusive of share-based compensation were $9.9 million and $11.1 million for the fourth quarters of 2022 and 2021. For the full-year periods, R&D expenses inclusive of share-based compensation expense were $45 million and $51.1 million respectively. The primary drivers for the decrease was a $10 million license and milestone obligation related to AUR 300 expense in 2021, which was partially offset by additional development expenses related to AUR 200 and AUR 300 in 2022. Non-cash R&D share-based compensation income and expense was $260,000 and $1.2 million for the fourth quarters of 2022 and 2021. For the full year, 2022 and 2021 non-cashier basic compensation expenses were $3.3 million and $4.4 million respectively. Interest income was $2.9 million for the fourth quarter ended December 31, 2022 versus $109,000 for the prior year period. For the full year, interest income was $5.1 million compared to $529,000 for the prior year period. The increase was mainly due to higher yields on our investment, a result of increasing interest rates. For the fourth quarter of 2022, ARENIA recorded a net loss of $26 million or $0.18 net loss per common share compared to a net loss of $33.3 million or $0.25 net loss per common share for the prior year fourth quarter. For the full year of 2022, ARENIA recorded a net loss of $108.2 million or $0.76 net loss per common share compared to a net loss of $181 million or $1.40 net loss per common share for the prior period. With that, I'd like to hand the call back over to Peter for some closing remarks. Peter?
spk06: Thanks, Joe. As you heard throughout the call, we remain encouraged by the progress we're making and remain optimistic about the overall opportunity for loop kindness. We saw a positive impact from our efforts in the fourth quarter, and that momentum continues into the first quarter of 2023. We remain focused on delivering loop kindness to patients in need and driving results in the US and globally. We look forward to keeping you updated along the way. I want to thank everybody for joining us today. We'll now open up the call for questions. Operator?
spk08: Thank you. And at this time, we will be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. We also ask that each participant to please limit themselves to only one question and one follow-up question. One moment, please, while we poll for questions. And our first question comes from the line of Maury Raycroft with Jefferies. Please proceed with your question.
spk07: Hi, good morning, and thanks for taking my questions. You got higher, I think it was 274 patient start forms in the first two months of 2022 or of this year versus 201 patient start forms in a similar period last year. And in March, I think you got a lot more PSFs to end up with 461 for the quarter for last year. Do you expect March 2023 to be similar to March 2022? And maybe talk a little bit more about the cadence of PSFs for this year and how you expect that to play out.
spk06: Well, hey, thanks for the call, Maury. If you look at PSF progress through the first quarter, and I think as everybody knows, we report total PSFs towards the end of each queue and report that. But then we report where we are with PSFs as a leading indicator all the way through the most updated date we can. leading into the quarterly call, which on this call is February 24th. A couple things. If you just back calculate the 274 to a number of prescriptions per week and per day, you can see that we're seeing more in the first quarter than we saw even in the fourth quarter. And I think that's building off the trend of both November and December growth that we saw and the actions that we put in place during Q3 to drive that. If you look at the month of March for 2023, there's just under five weeks. So we've got, you know, call it five weeks or so of reporting left. And if you calculate just the average number per week we've seen year to date, you know, you should get at around or above that number that you just recently mentioned, Maury. Listen, we hope to see You know, the type of progress that we saw last year, which, as you just recounted, is our best month I think we saw since launch, coming off sort of the tail end of the first quarter. So progress on PSFs we're encouraged by, and we look forward to reporting more out on it when we report the first quarter.
spk07: Got it. That's helpful. Thank you. And maybe one other question for the Sun settlement terms. When do you plan to disclose more about that? Can you comment generally on whether any of the terms are tied to some sales of SECWA?
spk06: The latter part of the question, again, I'm sort of tied to a confidentiality here, and I know that's frustrating for people. But, you know, generally speaking, the latter part of your answer, no. And I think the best way to think about this agreement is it's, you know, we are and they are not able to, you know, litigate and or drive litigation against either product and, you know, for the foreseeable future. So the positive is not only these elements in terms of the challenges we were currently having against one another move away, but also and the prospects of any future litigation. In terms of more disclosure, It kind of comes down to, you know, finalizing the, you know, the elements of our first ongoing litigation we have with them, the patent infringement lawsuit. And then, you know, there is always the prospect that more comes out. But, I mean, the gist of what the agreement is is already out there, and as I just communicated.
spk07: Got it. Okay, I'll stop there and hop back into you. Thank you very much. Thanks, Maury.
spk08: Our next question comes from the line of Olivia Brayer with Canada Fitzgerald. Please proceed with your question.
spk02: Hey, good morning, and thank you for the question. I want to ask about payer changeover headwinds this quarter and whether you're seeing any positive impact to start the year from the insurance verification efforts you've been focusing on. And then it looks like United changed their pre-auth rules in September, and I think that went into effect in December. Can you give us any color on whether that's helped with getting patients on therapy so far this year and whether you have a sense if other insurance providers may do the same?
spk06: Well, I think it's a good question. Thanks, Olivia. First off, all I can say is the efforts we put into Q4 as it pertains to verifying, helping patients to verify ensuring patients are ready for the year-over-year changes, we're hopeful that those will have impact. I think a couple things that we have reported that should point to that and sort of lead into your second question are, first, our PSF rates are looking good entering the year. You know, I think that's encouraging. And in terms of our speed to getting patients on therapy, look really strong as well. And I think that is part of managing a better process, but alongside of it is also a part of some of the payer policy changes we're starting to see. As we've said through the start of the original launch of this product, the more patients we get on drug, the more velocity of patients that we can put through the system, the more we believe, and you can witness this for other drug launches, not just ours, that payer policies will start to come in line with where physicians and payers believe the drug should be utilized. And, you know, I think if you look at our, you know, our 60, I believe it's 60% of our patients now are getting drug within the first 20 days now. So I think that's a direct a reflection of the work that we're doing in Arena Alliance, reflected in the fourth quarter, but over time, and of course, payer policies coming in line over time.
spk02: Okay, great. Thanks, Peter. And then maybe just, you know, a follow-up to that. Do you expect other insurers to actually do the same as United? Any insight into when that could potentially play out this year?
spk06: Well, I think we walk the delicate balance of, you know, trying to let the clinical adoption process and patient volume be the biggest driver of how, and of course educating payers, but those being the two biggest push factors against getting payer policies to change versus going in and just offering margin and discount to try to, you know, ease access. I think we're striking the right balance. And I think over time, the best way to measure that for everyone listening today is going to be the percentage of patients that we convert, and then second to that, how fast we convert them. And I think all of those have been improving for the last 18 months, and we'll continue to see improvement. And I think if you benchmark them versus other drug launches out there, we're actually doing better than most.
spk02: Okay, great. That's helpful. Thanks.
spk06: Thanks, Olivia.
spk08: Our next question comes from the line of Stacy Koo with Cowen. Please proceed with your questions.
spk10: Hi. Thanks so much for taking our questions. So we have a few. A follow-up first for Q1. Given all the improvements you stated for conversion rates and timing to pay drug, how should we think about the high deductible resets for Q1? you've stated that there's 1,525 patients exiting Q4. So what might be the expected patient base from Q4 going into Q1? And to just follow up on the question, how should we think about the seasonality in patient start form additions as we think about the year, for instance, as we consider summer or winter holidays? Thank you so much.
spk06: The first question is, you know, I don't mean to punt on that, but, you know, it's a We're currently in the quarter working at. There are certain things that we provide within the quarter, but that's one we continue to work through and rather wait until the end of the quarter to give you a realistic accounting of how we actually did. I can tell you very qualitatively we feel real good about the work that we did in the fourth quarter in terms of year-over-year progress and where we were last year January doing this versus where we are this January. And I think our learnings from last year were applied. So we think positively about the progress we made in carrying patients from the fourth quarter into the new year based upon all that disruption we typically seen. But in terms of a real sort of quantitative number, we're gonna have to wait to the first quarter before we report that. Second, so takeaway, we feel good, but waiting for the first quarter roll-up and to give you exact numbers of what we carried over. On the PSF trend front and overall, because I think it's patients on therapy as well as PSFs, how should we be thinking about seasonality as we enter the summer? Well, we had two confounding factors over the last two years of the launch, you know, that have been, you know, things that we're watching and trying to figure out. I think in the first year, there was a lot of COVID noise as we entered the summertime. You know, we had a spike in one of the variants right before the summer, and I think as we saw it, it was another lockdown period that in the first year of the launch drove a lot of the summertime slowdown. Well, we didn't have that last year, but we saw sort of this seasonal dip in the summertime that as we looked at it, we could track it back to diagnoses, we could track it back to patient visits, we could track it back to our individual rep activity, all the way through the entire chain of how a patient gets diagnosed, treated, and then kept on therapy, we saw less activity. our hope would be that this year we sort of washed out that post-COVID, you know, everybody sort of running off on vacation, people spending more time during the summertime, making up for lost time and vacations, and we see more continuity in the business as we push through the summer. But I think it remains to be seen. I would say feel very comfortable that in terms of tactics and our approach to the summer months, that we are putting an incredibly intense amount of time and work against ensuring that we get continuity of care of patients and that we continue to drive prescription StarForm or patient StarForm growth throughout the summer months. So to be determined, we're watching it closely. The last two years have been inconsistent in terms of what the impact's been each year during these time periods. And we are going to put a tactical plan to try to push through and ensure that we can see consistent growth throughout the year for PSFs and patients on therapy, and, of course, as a result of that revenue.
spk10: Very helpful. Thank you.
spk08: Our next question comes from the line of Ed Erst with HC Wainwright. Please proceed with your question.
spk01: Hi, guys. Thanks for taking my questions, and congrats on the continued progress on the launch. For me, I just wanted to ask a couple questions. First, on the PFS, as you mentioned, growth in November and December really started to separate from prior months, and it's gotten stronger so far this year. Just wondering, I know that you've touched upon this in some of your comments, but I was wondering if you could sort of explicitly list what's really behind that. What are the drivers? What things have you changed recently in terms of learnings over the last few months? And then sort of the same in terms of retaining patients. You know, PFS, getting you patients, and basically the same question in terms of, you know, retaining patients longer term. as you mentioned, nearly a half are on treatment still at 12 or 15 months. Thanks so much.
spk06: Thanks, Ed. So Ed's starting point was the point that we made about the growth we saw in November and December, and I think you have to look back to what we reported in October when we reported 3Q that led you to the growth in November and December was quite different than what we saw as we entered into the month of October. So why, right? And then on the back end of that, why are we seeing strong retention and actually good improvement in speed to transition from PSF to START? A lot of this is going to be a tactical answer, Ed, but I think therein lies what I think the impact has been up to this point. I think we have, with our field sales organization, and I'll envelop into that our appropriate medical efforts in education, we have really focused our efforts towards, one, high decile prescribers. Not that those haven't been important since launch, but we more have spent our time working where we believe the highest number of patients are, both across rheumatology and nephrology, and being very religious about how we're not just setting direction, but also tracking call activity and impact against those targets. So targeting, highest deciles, and intense focus against those now. really digging into our data and going back and not looking just at who our repeat prescribers are, but looking at a host of physicians who've tried the product but have not moved from trial to actual adoption. So taking that data, slicing it, and getting into, okay, you've got your physicians who are treating regularly and have multiple patients on the drug, but let's get really close to those physicians who've tried the drug revisit and get them to move from trial to more broad-based adoption. I think those activities have made a difference. I also think that our work around the conferences, we had ACR and other conferences that moved to live versus in the past have been more virtual. And lastly, I think the access is just improving. I can't give you an actual statistic on this, but You know centers that were very locked down or starting to to to open up and no see physicians in terms of you know the. Maybe major medical centers or physicians who had policies that were adopted in coven are starting to open up more so I think our access to some of these targets has has improved. that's some of the mix I could also put in there are our new campaign, the work I think we're doing around. patient work that's driving more patients into offices and hopefully retaining more patients. I think the whole tactical mix is having a difference. And on the retention front, I think it's twofold. One is a very intense increase on the amount of work we're doing on patient education, retention, diagnosis. Across the board, we've really amped up our strategy there and our activity as a result. And then second, our Irinia Alliance folks have been intently focusing on not just the base of patients that we have in PSFs that have not converted, but put more FTE support and more tactical support against ensuring that we stay in regular contact with patients and even putting new initiatives in place like text campaigns and things to connect with the patient on their level. So very long-winded answer, but it gives you an idea of some of the tactical work that we've been doing to try to drive these results. And we think so far we see the impact of it. We hope to see even more moving forward.
spk01: That's great. That's very helpful. One follow-up then for me. As you mentioned, you expect initial sales out of the EU sometime in the first half of this year. Do you have perhaps even just qualitatively any sense for guidance or not specific guidance, but just any sort of sense for the magnitude of sales at least this year, sort of what we could expect out of those perhaps three out of the five EU countries? Thanks.
spk06: So we've tried to be relatively conservative here, Ed, and it's not because we don't have a lot of passion and believe that the XUS markets can contribute. One, I think we have to look at, you know, analog products out there. And if we just look at, and this data may be slightly dated, but I think directionally accurate. Our comparator, Ben Lista, has historically seen somewhere between 10 and 15% of their sales come from XUS markets. You know, we've always said that we believe the greatest impact that we can have financially, not from a patient base, but financially, is going to be in the U.S. market. Hard to really give a quantitative answer to that, so I would say qualitatively for the year, you know, I wouldn't plug a lot here, and I would say it's upside for us. Until we get a good idea of where we get benchmark pricing in these countries, You know, it's pretty hard to tell, right? So I think best to have it as an upside for the company, but one that I would, until we have pricing and reimbursement in a few large countries, it's just hard to know. But going back to what I said earlier, if you use a global benchmark over time, I think, you know, some of these analog products might be helpful. So we'll have to see as we see what pricing and reimbursement looks like in these countries, and I would think about it as upside. At least that's how we see it, and we try to get very concrete about timing around major milestone payments because those are real and they're sizable.
spk01: Great. Thanks again. I'll get back in the queue.
spk06: Thanks, Ed.
spk08: Our next question comes from the line of Joseph Schwartz with SVB Securities. Please proceed with your question.
spk04: Hi, thanks so much. It's great to see such a strong improvement in the trajectory as a result of some real fundamental tailwinds. So I guess my question is, can you quantify for us in any manner how much more room there is for this acceleration to continue? As a result of some of these things like payer policy changes and access to accounts, and other marketing initiatives, is there any way for you to help us understand how much more room for growth this supports? Just because you were growing initially quite well and then saw a deceleration in patient start forms last year, and I'm just wondering how durable this acceleration is and whether or not it might also wane at some point.
spk06: Well, thanks, Joe. I actually think that's a great question. First, to try to quantify the opportunity, I think we put, well, I know, we put data in this call from an Optum study a couple years back that shows that on previous calls, we've talked about this element of market development, like this lupus nephritis area has a lot of room to grow in terms of not just new drugs coming into the market, but how patients are assessed, diagnosed, and treated, right? If 50% of SLE patients, only 50% right now over a very large sample, are getting screened for proteinuria, if we could get 75%, 80% of those patients to just get screened, the top end of the funnel grows dramatically. But it's always hard to predict how long that will take, right? But I think tactics like our urinalysis campaign and even getting more aggressive about how important that is are going to be helpful there. So hard to say what our expectations could be of what the top end could be, but I think it's sizable. If 100% of those patients, 30% or 40% actually have problems in terms of proteinuria, just by getting more of them screened is going to put more patients in the front end of the bucket. You know, optimization of our business in terms of getting patients on drug faster, working the queue of the PSFs we have, you know, we'll continue to see opportunity there, but eventually you're going to hit a point of, hey, you've got a really well-run machine here, and it's all going to be about how many patients you're putting into the queue. I think we've got to put up a couple quarters to show you that we can consistently grow it, And I think the, my eye goes to the opportunity here is big because we don't even have a market where patients are being screened the right way, but it's going to take time. And the best way to look at it is to see some quarters quarter on quarter results. Um, that's like the best I can tell you, we got it. We actually have to prove that we can grow quarters and, uh, you know, the data that's outside of a Renia like this Optum study show that these patients are there. and if better diagnosed, gives us a greater opportunity to find them and get them more aggressively treated.
spk04: Okay, that's very helpful. Thanks, Peter. And then it looks like the WAC for Lepkinis increased about 8% earlier this year. So how should we be thinking about the average net price and the gross to net looking forward?
spk06: Joe, you want to take this one or you want me to handle it?
spk05: I can take it, Peter. Yeah, the price increase we took towards the back half of 2022 starting to bleed into 2023. Just remember that based on payer mix and other things like that, Joe, it all doesn't flow through to the bottom line. So I would say if you're kind of looking at overall price increase, about half of that actually makes its way through our gross to net calculations at the end of the day.
spk06: Okay, and just to mention one thing, Joe, on that. Joe mentioned back after the year, we took a price increase in the last month of the year, so the price increase is not realized in our, really realized in our 2022 numbers. It's a 23 factor.
spk04: Okay, got it. Thanks again.
spk08: And our next question comes from the line of Justin Kim with Oppenheimer. Please proceed with your question.
spk09: Hi, good morning, and thanks for taking my question. Peter, the team's done a really great job giving fair guidance over the quarters. And so as we think about the $120 million to $140 million into this year, how should we think about the puts and takes towards achieving the low versus high end? Just because our estimates and assumptions kind of land us closer to the higher end and just trying to understand what headwinds and tailwinds may change this trajectory.
spk06: Yeah. I mean, listen, I think, um, as if I'm hearing what the company's reporting out today, I would say we've done a really strong job at, um, working all the elements of, of our patients through the system. And we're doing a real, a good job keeping patients on drug, getting them on drug faster. you know, sort of working the back end of the process once the patient's identified, and we're seeing good pickup in terms of PSS. The range for me, you know, first I think you can land in the range if you sort of just continue to optimize the business. But how you get to the outside of the range is you have to see, and, again, this is a fairly qualitative answer to a quantitative question. To me, how you get outside the range is you see a pickup in PSFs, and it's going to take the first quarter report to know whether the trajectory is in the right direction. I think everything through the February 24th point tells you it's picking up speed. A headwind against that could be, to the previous question, if we see this seasonality thing kick up on us again in the summer months of the year, or if that was two years of anomaly based on COVID and COVID hangover second year once the COVID crisis sort of moved past us. If those things continue to be there, then that could slow down our PSF activity. But to me, it's all about the number of patients we're putting in the top end of the funnel. And if we can continue to see solid progress against that, you get to the upper end or potentially outside of our guidance range. And the first quarter is going to be the time where we're going to have to address that based upon the absolute result.
spk09: Okay. Great, great. And maybe just a separate line of questioning. On the scientific presentation expected this year, is there any chance for seeing biopsy data out of Aurora 2 subpopulations?
spk06: Yeah, as I've noted historically, just the one caveat around this, this is a sub-study that was done within the original Aurora study of a low number of patients, and a low number of patients just because obviously a biopsy is an invasive procedure, so it's hard to get patients to commit to it. But, you know, a sizable enough end where we can look at another measure of impact of the drug on the disease and impact of the drug more specifically on the kidney by doing a view of what's happening in the actual kidney through biopsy, staining, et cetera, and histologically. Our hope would be that we can get something to you this year. So stay tuned, I guess, is what I would tell you. Great. Thanks for taking the questions. Thanks, Justin.
spk08: And we have reached the end of the question and answer session. And I'll now turn the call back over to management for closing remarks.
spk06: Well, I think as everyone's heard through the call today, we're excited about the progress we're seeing early in 2023. We look forward to continue to keep you updated on calls to follow. We want to thank you all for joining us today. Have a good day.
spk08: And this concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.
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