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spk04: Greetings, and welcome to ARENIA Pharmaceuticals' full year 2023 earnings call. At this time, all participants are in 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, Andrea Christopher, head of the Corporate Communications and Investor Relations for ARENIA Pharmaceuticals. Thank you. You may begin.
spk05: Thank you, Operator, and thank you to everyone for joining today's call and webcast. Joining me on the call this morning are Peter Greenleaf, ARINIA's Chief Executive Officer, and Joe Miller, our Chief Financial Officer. Today, we will review and discuss ARINIA's 2023 fourth quarter and year-end financial and operational results, as well as an update on our strategic review, as communicated in the company's press release issued this morning. The company also filed its annual financial statements on Form 10-K this morning. For more information, please refer to Arrhenia's filing with the U.S. Securities and Exchange Commission and applicable Canadian securities authorities, which are also available on Arrhenia's website at arrheniapharma.com. During today's call, Arrhenia 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 discussion of factors that could affect Arrhenia's future financial results and business, Please refer to the disclosures in ARINIA's press release and its annual report on Form 10-K, and all of its recent filings with the U.S. Securities and Exchange Commission and Canadian securities authorities. Please note that all statements made today during today's call are current as of today, Thursday, February 15, 2024, unless otherwise noted, and are based upon information currently available to us. Except as required by law, ARINIA assumes no obligation to update any such statements. Let me turn the call over to Arunia's President and CEO, Peter Greenleaf. Peter?
spk03: Thanks, Andrea, and good morning, everyone. I want to thank everybody for joining us on today's call. As you may have noted, we issued preliminary, unaudited fourth quarter and year-end numbers in early January. On today's call, we will provide you with the final audited results for the fourth quarter and the year-end 2023. We'll also provide an update on our commercial activities. including key commercial metrics and significant highlights for Lubkinis. We will then provide an update with the company's previously announced strategic review and our business strategy moving forward. This includes our near-term plan to restructure the company and the initiation of a share repurchase program. We believe this plan allows for immediate enhancement of shareholder value and has the ability to strengthen the company's long-term financial picture. After walking you through these details, I will then turn the call over to Joe Miller, our CFO, to provide additional details on our financial results. So now let me dive into the overall business performance. For the full year 2023, Arena achieved $175.5 million in total net revenue, which represented an increase of approximately 31% over the prior year. We achieved $158.5 million in net product revenue, representing an increase of 53% over 2022. For the fourth quarter of 2023, we achieved a total revenue of $45.1 million and a total net product revenue of $42.3 million, which represented an increase of 59% and 49% over the same period in 2022. Moving to more detail behind our financial results, during the fourth quarter, Irinia added 438 patient start forms, or PSFs, compared to 406 PSFs in the fourth quarter of 2022 and 436 in the third quarter of 2023. In addition to the 438 PSFs added in the fourth quarter, the company also added approximately 101 new additional patients. This includes restarts, defined as patients coming back onto therapy who do not require a PSF, and an estimate of new patients beginning therapy in the hospital channel. The addition of patient restarts and patients coming through the hospital channel are newly reported in the fourth quarter since they've achieved numerical significance for the first time. Hospital and restart numbers are both new indicators of growth for us. We know that restart patients have been off therapy for a considerable amount of time before restarting. Restarts represent a strong indicator for the brand because they demonstrate that physicians are comfortable using loop kinase as a first-line therapy, and they likely indicate the importance of maintaining loop kinase for a sustained period of time. It's important to note that treating flares is not aligned with the most recent treatment guidelines. These guidelines out there call for patients to remain on therapy for three to five years. I'll talk more about our commercial strategy in a moment, but this is why we continue to encourage physicians to follow the guidelines and treat lupus nephritis more aggressively. Regarding our hospital numbers, we ship wallets to hospital pharmacies with little to no visibility into how these hospitals are dispensing the drug to actual patients. Therefore, we estimate how many patients come from those wallets based on average wallet utilization across all patients. As previously discussed, the hospital market was completely closed off to us for the first two years of the launch due to the global pandemic. Now that we have a broader hospital access, we're looking closely at how we approach these institutions and addressing some of the complexities that are inherent in the hospital systems and integrated healthcare networks. We're beginning to see the impact of our execution in this space with the wallet shipments and patients beginning to pull through. For the full year, we added a total of 1,791 PSFs, an increase of approximately 9% year over year. And from January 1st, 2024 through February 9th of the same year, we added approximately 191 PSFs. Adding to the PSF number, we have approximately 40 new patients from both restarts and the hospital channel. In addition, I'm pleased to report that our conversion rates continue to improve, with approximately 85% of PSFs converted to therapy. We're also improving the time it takes to get patients on therapy. Throughout 2023, we increased our processing speed at all time periods, 30, 60, and 90 with 63% of our patients starting therapy in 20 days or less. I'd like to point out that this is a meaningful improvement year over year. Our 12-month persistency continues to improve and is now approximately 55%. We are encouraged to see almost 45% of patients remain on therapy at 18 months, with that number holding steady out to 24 months. And consistent with prior periods, adherence to loop kinase treatment remained strong at approximately 86% at year end. The increase in patients on therapy in the quarter was driven predominantly by improvements in new PSFs, patient restarts, hospital fills, conversion rates, and processing speeds, and overall improvements in persistency. Exiting 2023, a total of 2,066 patients were on therapy. This represents an increase of over 35% over 2022. As we stated on previous calls, our strategy to grow loop kinase in the lupus nephritis market is focused on three key areas. The first, educating healthcare providers on the need to screen and treat more aggressively. Second, Activating the patient to proactively discuss screening and treatment with their physicians. And lastly, continuing to clinically differentiate loop kinase and position it as part of the foundation therapy in the treatment of lupus nephritis. To address the first, we continue to increase our focus on healthcare professionals and key opinion leaders by leveraging our long-term clinical data and the updated ULAR and CADEGO guidelines. Our messaging is focused on encouraging physicians to recognize that all SLE patients may be at risk for lupus nephritis and that active screening and routinely monitoring lupus nephritis patients are critical. Prioritizing early diagnosis with every SLE patient. Treating to target goals and reducing protein levels to minimize steroid use. Start treatment with an effective combination therapy and leverage combination therapies with the goal of increased renal response. And lastly, continuing to treat for at least three to five years following a complete renal response. We're already seeing meaningful impact from these clinical developments, and we will continue to reinforce this messaging through our robust marketing and sales efforts. In terms of patient activation, We focus our efforts on educating SLE and lupus nephritis patients and driving them to have provocative and proactive conversations with their physicians about screening and treatment. Our messaging reinforces the importance of routine urine screening, the seriousness of the threat of lupus nephritis progressing, and the critical need to start and stay on treatment. We deliver these messages through a mix of highly targeted social and digital initiatives as well as in-person advocacy events. Finally, our customer facing teams are focused on clinical differentiation and delivering the loop kindness clinical story targeted towards the highest potential writers. Our activities against these targets have steadily increased throughout 2023. And in the fourth quarter, we further increased the depth of prescribing in our current base of customers. And in addition, expanded new customers and new writers. Building on the momentum we established in the fourth quarter, we now have over 5,000 PSF since launch. And based on everything we've discussed today, we're reaffirming our 2024 net product revenue guidance range of $200 to $220 million. Shifting gears, I'd like to now discuss the conclusion of our strategic review and provide additional context. Please note that you will find further details of the review located within our recently issued annual report on Form 10-K and related press release. To remind everyone of how we got here, in connection with our annual general meeting held May 17th of 2023, certain shareholders expressed their desire for the company to undergo a strategic review process. At the 2023 AGM, Two of the company's most senior and experienced nominees for directors did not receive requisite majority under the company's majority voting policy and accordingly submitted their resignations to the board. Those resigning members were replaced with two new directors, both with significant pharma and business development backgrounds. And additionally, in connection with the collaboration agreement that we entered into with one shareholder, we agreed to appoint Dr. Robert Foster, the inventor of Vaklosporin, to our board. Given the results of the AGM, as well as the desires expressed by certain shareholders, on June 29th of 2023, the company announced that it had initiated exploration of strategic alternatives. It was noted that the process would consider a wide range of options for the company, including but not limited to a potential sale, merger, or other strategic transactions. The company retained J.P. Morgan as its financial advisor to lead the strategic review. Following the announcement of the process, J.P. Morgan and Arinia put together a comprehensive data room, a corporate presentation, and materials to support the overall review process. J.P. Morgan then engaged with more than 60 parties. That engagement led to 11 non-disclosure agreements being signed with potentially interested parties. ARINI also conducted multiple meetings and presented to multiple parties, including some that did not sign nondisclosure agreements on a non-competential basis. The data room itself was extensive, containing over 200,000 pages of materials across 4,300 files. Despite significant effort put into the exploration of strategic alternatives from ARINI's board, its management, and our advisors, only one party submitted a preliminary non-binding expression of interest, which remains subject to customary conditions, including a formal due diligence. After review of that expression of interest, Arrhenius Board elected to allow that party into a detailed formal diligence process. At the conclusion of its diligence process, the counterparty elected not to submit a formal offer. In addition to exploring the sale of the company, ARINIA also explored multiple alternatives, including the potential for acquiring, merging, or licensing other entities or assets. The Board ultimately determined that none of the other alternatives explored and that were available to it to pursue were in the best interest of the company and its shareholders. Based on the outcome of this extensive strategic review, The board believes that the best path forward is for management to streamline its operations as announced today and focus on the company's commercial execution. We expect this to provide us with financial firepower to generate meaningful cash flow, which we intend to redeploy in the short term to repurchase shares and over time continue to build balance sheet strength. We believe this strength will provide us with the financial flexibility to consider a wide range of alternatives over the next few years. This could include diversifying our portfolio through the addition of new pipeline assets or creating scale through the acquisition of commercial assets or other strategies that we believe will allow the company to continue to grow and drive towards its mission. For even more context, in 2018, The company under previous management and at the board's direction engaged a leading investment bank and conducted a confidential strategic review process. After extensive outreach, the company received only one non-binding expression of interest, which included a due diligence process, but in the end did not result in a formal offer. And outside of these two expressions of interest, the company has never received any offer of any kind. The board and management, though, remain open to exploring opportunities that are in the best interest of the company and are open to considering any bona fide offers that the company receives. In addition, following the conclusion of the strategic review, the company is reaffirming its commitment to the value enhancement by driving loop kindness growth while maintaining a sharp focus on operating efficiencies and maximizing cash flows. As a result, the company is ceasing further development of both AUR 200 and AUR 300. Correspondingly, the company expects to take a restructuring charge of approximately $11 to $15 million in the first quarter of 2024. This charge will primarily be made up of severance costs, contract termination costs, and other costs associated with terminating these programs. We anticipate reducing employee headcount by at least 25% by the end of the first quarter of 2024. There is no planned reduction in headcount in commercial or commercial supporting roles. The company expects to recognize annual cost savings of approximately $50 to $55 million on a go-forward basis with no impact on our commercial investment. In addition, the Board has approved a share repurchase program of up to $150 million of the company's common shares, the maximum amount of which is subject to receipt of regulatory approval in Canada. This reflects confidence in Arrhenius' growth prospects and a continued commitment to enhancing both short and long-term value for shareholders and other stakeholders. While we know there will be questions about timing and details of this near-term strategic shift, I can tell you that we will execute quickly and decisively to maximize the benefits. I'd now like to turn the call over to Joe to provide additional details of the share repurchase program that we announced today, as well as more detailed review of our financial results. I will then return at the end of the call for a quick recap and to open up the line for your questions. With that, Joe.
spk02: Thank you, Peter, and good morning, everyone. As Peter previewed, the Board has approved the Share Repurchase Program of up to $150 million in common shares of the company, of which the maximum amount is subject to receipt of exemptive relief in Canada. If granted, it would permit ARENIA to purchase up to 15% of the issued and outstanding common shares of the company in any 12-month period over 36 months. There is no assurance that exemptive relief will be granted. If the exemptive relief is not granted, the maximum the company may purchase under the Share Repurchase Program is 5% of our current issued and outstanding common shares being 7,230,888 common shares. We plan to begin opportunistic discretionary purchases of shares on the open market beginning on or around February 21st, 2024. The company expects to fund the share repurchases from cash flows from operations and cash currently on hand. Further details can be found in our recently issued press release in Form 10-K. I want to emphasize that this repurchase program truly reflects our confidence in ARENIA's growth prospects. Now let's take a few moments and go into detail regarding our financial results for the fourth quarter and 12 months ended December 31, 2023. As of December 31, 2023, ARENIA had cash, cash equivalents, and restricted cash and investments of $350.7 million compared to $389.4 million at December 31, 2022. The decrease is primarily related to the continued investment in commercialization activities and post-approval commitments of our approved drug loop kindness, inventory purchases, advancement of our pipeline, and monoplan payments, partially offset by an increase in cash receipts from sales of loop kindness. Total net revenue increased 59% to $45.1 million for the fourth quarter, compared to the prior year period of $28.4 million. Total net revenue for the year was $175.5 million, an increase of over 31% over the prior year period of $134 million. Total net product revenue increased 49% to $42.3 million for the fourth quarter compared to the prior year period of $28.4 million. Total net product revenue was $158.5 million and $103.5 million for the years ended December 31, 2023 and 2022. The increase in both periods is primarily due to an increase from our two main customers for LoopKindness sales, driven predominantly by further penetration of the LN market. Licensed collaboration and royalty revenue was $2.8 million for the fourth quarter compared to the prior year period of $109,000. Licensed collaboration and royalty revenue was $17 million and $30.6 million for the years ended December 31, 2023 and 2022, respectively. For the years ended December 31, 2023, licensed collaboration and royalty revenue included a $10 million pricing and reimbursement milestone and additional collaboration and manufacturing service revenue for Matsuuka. For the year ended December 31, 2022, licensed collaboration and royalty revenue was primarily due to the recognition of a $30 million regulatory milestone for Matsuuka following the EC marketing authorization of Loop Kindness in September of 2022. Cost of sales and operating expenses for the fourth quarter ended December 31, 2023 and December 31, 2022 were $74.8 million and $56.5 million. Total cost of sales and operating expenses were $267.2 million and $245.5 million for the years ended December 31, 2023 and December 31, 2022. Let me now give you a further breakdown of operating expenses, drivers, and fluctuations. Cost of sales were $5.4 million and $1.4 million for the quarters ended December 31, 2023 and December 31, 2022. Cost of sales for the year ended December 31, 2023 were $14.1 million and $5.7 million for the year ended December 31, 2022. The increase in both periods was primarily due to increased sales of loop kindness coupled with the amortization of the monoplant finance lease right-of-use asset, which was placed into service in late June 2023. Gross margin for the quarter ended December 31, 2023 and December 31, 2022 was approximately 88% and 95%. Gross margins for the year ended December 31, 2023, and December 31, 2022 was approximately 92% and 96%. Selling general and administrative expenses, inclusive of share-based compensation expense, were $50.1 million and $47.5 million for the fourth quarters, 2023 and 2022, respectively. The increase in total SG&A was primarily due to an increase in share-based compensation expense. For the years ended December 31, 2023, SG&A expenses, inclusive of share-based compensation expense, was $195 million. For the year ended December 31, 2022, SG&A expenses, inclusive of share-based compensation, was $196.4 million. The decrease was primarily due to a reduction in expenses associated with corporate legal matters and insurance. Non-cash SG&A share-based compensation expense was $9.5 million and $7 million for the quarters ended December 31, 2023 and December 31, 2022. Non-cash SG&A share-based compensation expense was $36.5 million and $28.4 million for the years ended December 31, 2023 and December 31, 2022. Research and development expenses, inclusive of share-based compensation expense, were $10.2 million and $9.9 million for the quarters ended December 31, 2023 and December 31, 2022. R&D expenses, inclusive of share-based compensation expense, were $49.6 million and $45 million for the years ended December 31, 2023 and December 31, 2022. The primary driver for the increase in R&D expenses for both periods was due to an increase in share-based compensation expense. For the quarter ended December 31, 2023, non-cash R&D shared base compensation expense was $1.9 million. For the quarter ended December 31, 2022, non-cash R&D shared base compensation was income of $260,000. Non-cash R&D shared base compensation expense was $7.5 million and $3.3 million for the years ended December 31, 2023 and December 31, 2022. Other expense was $9.1 million versus other income of $2.2 million for the quarters ended December 31, 2023 and December 31, 2022 respectively. Other expense was $8.4 million versus other income of $1.5 million for the years ended December 31, 2023 and December 31, 2022. The increase in expense for both periods is primarily the increase of the foreign exchange loss related to the revaluation of the monoplant finance lease liability which commenced in June 2023 and is denominated in CHF. Interest income was $4.6 million for the quarter ended December 31, 2023 and $2.9 million for the quarter ended December 31, 2022. Interest income was $17 million and $5.1 million for the years ended December 31, 2023 and December 31, 2022. Increase for the quarter and full year was primarily due to higher yields in our investment as a result of higher interest rates year over year. For the quarter ended December 31, 2023, ARENIA had recorded a net loss of 26.9 million or 19 cents net loss per common share as compared to a net loss of 26 million or 18 cents net loss per common share for the quarter ended December 31, 2022. For the year ended December 31, 2023, ARENIA recorded a net loss of 78 million or 54 cents net loss per common share as compared to a net loss of 108.2 million or 76 cents net loss per common share for the previous period. With that, I'd like to hand the call back over to Peter for some closing remarks. Peter?
spk03: Thanks, Joe. I want to close by saying that we've built a strong foundation for Arrhenius growth. This near-term shift will make us financially stronger. In the years to come, it will allow us more financial flexibility to continue to explore a range of strategic initiatives. We have a deeply experienced management team that's dedicated and committed to driving commercial success of lupkinus and improving the lives of people suffering from lupus nephritis. We're looking forward to a continued strong performance carried through in 2024, and I want to thank you all for joining us and giving us your time today. I'll now open the lines for any questions. Operator?
spk04: Thank you. At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two 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. And our first question comes from the line of Maury Raycroft with Jefferies. Please proceed with your questions.
spk06: Hi, good morning. This is Faizi Non from Maury. Thank you for taking our questions. So for Peter, can you talk more about the assumptions and key drivers behind your revenue guidance of 200 to $225 million, and how you had like 231 patient starts and restarts factor in, whereas in the same time period last year, you had like 274. So just wondering on the assumptions.
spk03: Yeah, well, first, the assumptions to get to the range that we put out there in terms, and thank you for the question, of guidance factor and, as we said, all the elements of our business, right? But obviously, we've got a keen eye on the metric that you pull out, which is, you know, what's your new starts going into the first quarter and how does that potentially impact the full year view? If you look at our PSFs year over year, and then you add back in the new starts that we've had in the hospital channel, and then you project that on a daily basis towards the end of the quarter, I think what you'll see is that we're experiencing growth, albeit how significant depends on what the continued rate is from now until the end of the quarter. but should project out growth to the end of the first quarter versus what we did last year. So the PSF and new start number when you include all three of those looks quite strong to the first several weeks of the year. Recall also that our March is usually, at least historically, has been one of our best months. So we're not even factoring that in the numbers, but if you do factor that in the numbers, it could significantly contribute to the overall performance. But Farzeen, just to give you the overall, we have to continue to see the type of persistency we've seen. We have to see growth in restarts and in the hospital channel, PSFs for sure, time to get in patients on drugs. And, of course, the new patient starts that you point out. But it's across all elements. And so far, the first quarter read on those has been strong.
spk06: Makes sense. And then, if possible, for you to share more insights into the strategic review process, was the apprehension to buy primarily due to the valuation disconnect or something else? And do you think interested parties could come back to negotiate if certain, like, say, milestones related to the commercial sales or IP are met?
spk03: Well, I listened to the latter part of your question. As we said on the call, we remain open to any and all bona fide opportunities that are brought forward to the company. I can't speak for other parties, nor can I predict the future, but I can tell you that you have a board and a management team that will always remain open to alternative strategies. We don't need to necessarily run a strategic review process. We've always been open to to other opportunities. As for feedback to this specific process, listen, we had a variety of interactions with the parties involved in the strategic review process. And given the nature and the variety and the depth of these interactions, as well as the confidential nature of the strategic review process, we can't divulge additional details at this point. We also can't speak on any other party's behalf as the information would be material to their business.
spk06: Thank you for taking our questions.
spk04: Thanks, Fazeeq. Thank you. Our next question comes from the line of Joseph Swartz with Link Partners. Please proceed with your question.
spk01: Hi, all. This is Will on for Joe. Thanks for taking our questions today. Two from us. So just to start, zeroing in on the 101 patients that were restarted for those from the hospital channel, you provide a breakdown between the two. And do you see this as an area as a potential growth driver for 2024, and are there any kind of appreciable patterns between those patients who are restarting therapy? Thank you.
spk03: Thanks, Will. Yeah, the 101 is referring back to the fourth quarter result when we reported the numerical significance increasing in two channels that we hadn't really historically seen, and that's the patient restarts happening, which we think is a positive signal, and then the opening of the hospital channels. And as we've said, this split there, and, you know, listen, we've got one quarter of a trend here, so this could vary. But the split, at least in the fourth quarter, was more driven approximately 75% to 80% of those patients came on a restart basis, and about 20% of those patients came out of the hospital. As we look at the first several weeks of this quarter, So far, we've seen about 40 in the combination. And unfortunately, at least today, I don't have how that break percentage comes across. But I would assume it's similar to what we saw in the fourth quarter. We look forward to detailing this as we move forward. And I guess what I'd like to underscore here is that while we'll always continue to report how patient star forms come into the company, these other channels are going to become more important. And I think on a go-forward basis, it's going to be very important to look at net new patients, and that will be inclusive of these restarts that we've kicked out of our overall tracking under PSFs and channels like hospitals and other networks that haven't historically been purchasing. And we'll, as we always have, continue to give transparency in all areas.
spk01: Okay, great. Thank you for that. And then just quickly – thinking about the 9% growth in PSFs year over year, but seeing 35% growth in the patients on therapy, if I'm quoting your numbers right. Can you just talk a little bit about the dynamic between the two and how PSFs might be a bit of a leading indicator and kind of the time lag that's associated with that? Thank you.
spk03: Well, I think there's a couple things you've got to factor in, right? We've never said, nor will we say, that new patient starts aren't important to look at, but, you know... In the first couple years of the launch, there's always a question of how long will patients stay on drug over time and what will the persistency look like? And when patients do eventually come off a drug, do they come back to drug? And we're now starting to understand those dynamics better. So when you look at overall patient growth and when you look at that relative to new patients coming in, I think for us, and somewhat of it's a forecasting dynamic, right? Like it's the persistency that we've seen. And as reported in this quarter, we've seen improvements in 12-month persistency, now above 55% of 56%. And interestingly, when you get to 18 and then 24 months, we've seen at least up to this point sort of a flattening out of the curve. And I guess I would point to a couple things. New ULAR and Cadego guidelines emphasize very clearly that patients should be on medications, and this is irregardless of what medication, for three to five years. That hasn't been historically how physicians have treated this disease. So, you know, although guidelines have been pushing it, it's been treating episodic sort of flares of proteinuria, and I think those guidelines are helpful. Second, you know, in the last 12 to 18 months, we've launched different elements of data that have crossed a couple different key areas. One, three-year data looking at both safety and efficacy of the product. So we were first to have data out that far, in particular, looking at EGFR. That's an important safety component of tracking impact to the kidneys. And then 18-month biopsy data. So remember, in the first year, obviously, we only had the one-year Aurora study. So I think all that's impacting, and I think you've got to look at persistency alongside of new patient starts, and we have to be hitting on both.
spk01: Great. Thanks again.
spk04: Thank you. All right. Our next question comes from the line of Stacy Kuh with TD Cowan. Please proceed with your question.
spk07: Hi, thanks for taking our questions. So we had a few. So understand that you can't divulge too many details, but if we could just quickly follow up on an earlier question on strategic review. If you could at least self-critique, what do you think could be the best explanation following the strategic review? Do you think it could be related to something like IP? competitors coming, not getting enough traction with patient ads, just some commentary from yourself would be really helpful. Thank you so much.
spk03: So I'm going to repeat myself, but because of the confidential nature of the strategic review process, there's a limit to the details that we can provide, particularly when it comes to other parties' business decisions and how they saw things. So we can't speak on another party's behalf as the information could be material to their business.
spk07: Okay, understood. And then as you talk about kind of these patient restarts, as you think about kind of long-term, do you think this could really help improvements in retention? And then a quick follow-up on kind of your kind of conversion rates for this year and next year, do you expect to stick around that 85% to 90% level, or do you think that could continue to improve? Thank you.
spk03: Starting with the last question first, I think the 85 has been fairly consistent. While we've seen quarter-to-quarter, a percentage point or two directionally up or down, it's been, on average, pretty consistent, so I would hold that fairly consistent. In terms of conversions, I still think we have opportunity to continue to increase speed and time to conversion to getting patients on drugs. So I do think that's one that we can continue to work on, even though we're at a fairly high level getting 60% of patients on to, north of 60% of patients on to drug within 20 days. And then the persistency thing, if you look at the market research data we have and the claims data that we have internally, they show a pretty wide disconnect between what actually happens with patients in the market and where the guidelines are pushing things to go to in terms of two elements. Three, actually. One is diagnosis. We know that SLE patients, a low percentage, actually get a 24-hour urine screen when they come into a doc's office. We need to continue to improve on that. That'll grow the market. Second, treating to target. is second, so we know from our data that there's a proportion of physicians actually who only treat to high proteinuria above what the current guidelines recommend in terms of proteinuria level that would qualify a patient as having active lupus nephritis. So getting active treatment and treatment to target are key opportunities and goals for us. And then lastly, there's this element of physicians treating episodic proteinuria versus sticking to guidelines and treating for and keeping those patients in control for at least three to five years, which we think obviously bodes well for continuing to see at least stabilization, if not improvement in our persistency rates out past 12 months and 24 months. So all of those elements, I think, when you look at the data we have aligned with the guidelines and the market opportunity, bodes well for our growth in the future.
spk07: Thank you.
spk04: Thanks, Stacy. Thank you. Our next question comes from the line of Ed Ars with HC Wainwright & Company. Please proceed with your question.
spk00: Hi. Thanks for taking my questions. I have three. First, I wanted to ask about the share repurchase. If you could, you tell us what expectations you have for the timeline on the decision for exemptive relief, and is that something, if that decision comes in, is that something that you would announce publicly?
spk03: Well, why don't I start, and if I miss anything, Joe can jump in here. The exemptive relief, I don't know that we have an exact timeline for when we'll get a read back from the Canadian authorities on that. But without the exemptive relief, we have up to 5% of our market cap that we have the ability to initiate without that exemptive relief. So as mentioned on the call, at or around the 21st of February is when we would you know, have the ability to be in market if we so chose. And at that point, we would not need the exemptive relief to at least do up to 5% of our market cap. After that would be how we expand above if we get that exemptive relief. Joe, did I miss anything?
spk02: To answer your second question around that, Ed, we would also announce that exemptive relief was granted if and when it was granted.
spk00: Okay, great. Secondly, just in terms of the growth drivers, you've been consistent over a number of quarters on how educating physicians and activating the patient is really critical here. And I'm wondering as you work through the dynamic of this market in getting both patients and physicians, even more importantly, changing the paradigm of the way they treat. Maybe talk about some of the more recent wins that you see and changes in attitudes and perspectives and what is currently working right now.
spk03: Well, as we mentioned on the call, although we didn't give the exact numbers, I can tell you we've seen significant improvement in both depth of prescriptions and breadth of prescriptions. So we're going deeper and we're going wider. So I think our ability to impact our 8 to 10 deciles, our Salesforce's ability has been there. And even in addition, the broader message of more aggressive treatment, novel therapies like loop kinase is getting out to the broader base of physicians. I would also point to, Ed, the progress that we've seen on persistency, both with improvements at 12 months and sort of a stabilization out to 18 and 24 months. I think those are both directly correlated to the data that we put into the marketplace that we produced through the extension study and through the biopsy extension as well, or the biopsy sub-study, and our commercial execution. We look forward to continuing to sharpen the edges of those results with more specifics, but I can tell you there's been progress on every front.
spk00: Okay, great. And then last question, if I may. You know, given the streamlined focus here on commercial execution of Leukinus, I'm wondering, you know, post the reduction in cost structure and head count, as you look towards the second half of the year, could you perhaps share any commentary on achieving near-term profitability and any growth in profitability over time? Thanks.
spk02: Yeah, you want to jump on that, Joe? Sure. Yeah, thanks, Ed. You know, as you know, we don't provide long-term guidance. We've indicated that on an analyzed operating expense basis, we've cut about $55 to $60 million in over the next 12 months, of which approximately 75% of that will be recognized in at least 2024. We do believe that with these reduced operating expenses and our focus on commercial execution, the time this grows specifically, we expect significant cash flows going forward on a go-forward basis. We obviously update you going forward on profitability. Some of this is tied to the timing around the restructuring charge as well as the share buyback plan. So further insights will come in the future, but for now we've kind of got it to a $55 to $60 million OPEX savings on an annualized basis.
spk00: Great. Fair enough. Thanks for taking my questions.
spk04: Thanks, Ed. Thank you. We have reached the end of the question and answer session. I'll now turn the call back over to Peter Greenlee for closing remarks.
spk03: Thank you very much. I want to thank everybody for their time today and we look forward to coming up on future quarters, reporting our results and keeping you updated on our plans. Thank you very much for joining us today. Have a great day.
spk04: This concludes today's conference and you may disconnect your lines at this time. Thank you for your participation.
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