Full Year 2024 Aurinia Pharmaceuticals Inc Earnings Call
Greetings and welcome to the Iridium Pharmaceuticals fourth quarter and full year 2024 earnings call. At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation.
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As a reminder, this conference is being recorded I would now.
Speaker Change: Now I'd like to turn the conference over to your House Andre Christopher <unk> of <unk>.
Speaker Change: Head of corporate communications and Investor Relations hernia. Thank.
Speaker Change: Thank you you may begin.
Speaker Change: 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, Araneus, President and Chief Executive Officer, Joe Miller, Erroneous, Chief Financial Officer, and Dr. Greg Keenan erroneous Chief Medical Officer.
Speaker Change: Today, we will review and discuss erroneous fourth quarter and full year 2024 financial results and provide an update on recent corporate progress as communicated in the company's press release and annual report on Form 10-K issued this morning for more information. Please refer to erroneous filings with the U S Securities and Exchange Commission and Canadian <unk>.
Speaker Change: Curators authorities, which are also available on our radius website at Iridium pharma Dot com during today's call Iridium 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 a discussion of factors.
Speaker Change: That could affect our radios future financial results and business. Please refer to the disclosures in erroneous press release annual report on Form 10-K, and all other filings with the U S Securities and Exchange Commission and Canadian Securities authorities.
Speaker Change: Please note that all statements made during today's call are current as of today February 27th 2025, unless otherwise noted and are based upon information currently available to us except as required by law or any assumes no obligation to update any such statements.
Speaker Change: Now, let me turn the call over to Iridium, President and CEO, Peter Greenleaf Peter.
Speaker Change: Thanks, Andrea and good morning, everyone I want to thank you all for joining us on today's call on this morning's call I'll provide an update on our fourth quarter and full year 2024 results and provide an update on our recent progress I'll then turn the call over to Joe Miller, our CFO to provide additional details on our financial results.
Speaker Change: With a continued focus on commercial execution and operational efficiency, we achieved significant growth in total revenue and record setting net product sales in the fourth quarter of 2024.
Speaker Change: For the fourth quarter of 2024 total revenue was $59 $9 million up 33% from $45 $1 million in the same period of 2023.
Speaker Change: For the full year 2024, total revenue was $235 $1 million up 34% from $175 $5 million in 2023.
Speaker Change: For the fourth quarter of 2024 net product sales of <unk>. The first FDA approved oral therapy for the treatment of adult patients with active L. N were $57 $6 million up 36% compared to $42.3 million in the same period of <unk>.
Speaker Change: 2023.
Speaker Change: For the full year of 2024 net product sales were $216 $2 million up 36% from $158 $5 million in 2023.
Speaker Change: The increase in both periods is primarily due to an increase in the number of loop kindness cartons sold to specialty pharmacies, driven by further L and market penetration.
Speaker Change: For three months ended December 31, 2020 for cash.
Speaker Change: Cash flow generated from operations was $31 million compared to $14 $3 million in the same period of 2023.
Speaker Change: For the year ended December 31, 2024 cash flow generated from operations was $44.4 million compared to cash flow used in operations of $33 $5 million in 2023.
Speaker Change: Following last year's strategic restructuring, we are pleased with how can how our cash flow improves throughout 2024.
Speaker Change: Exiting the year, we have cash cash equivalents restricted cash and investments of $358 $5 billion as of December 31, 2024.
Speaker Change: As we are now into our fifth year on the market, we believe that our historical financial results provide sufficient insight into the health of our business to project forward looking results. Therefore, we're not providing specific patient level metrics.
Speaker Change: With our strong 36% sales growth for loop kind of spring 'twenty 'twenty. Four we are poised for continued success and have a commercial strategy that is focused on four key growth drivers.
Speaker Change: First we've sharpened our focus on expanding our base of business at academic medical centers and lupus centers.
Speaker Change: We've also targeted key rheumatology prescribers segments and identified key lupus nephritis patient types.
Speaker Change: This would include newly diagnosed patients patients who are only on MMF and steroids patients receiving treatment, but not achieving treatment potential targets and potential for loop kindness restarts.
Speaker Change: Second we expect the new ACR lupus nephritis treatment guidelines to help drive positive momentum for loop kindness. This year and we're continuing to create a treat to target mindset among rheumatologists that drives the overall treatment urgency to screen and treat lupus.
Speaker Change: Right, it's more aggressively.
Speaker Change: Third we continue to reinforce the impressive three year efficacy data and safety data from our Aurora clinical program to clinically differentiate loop kindness and position it earlier in the treatment paradigm.
Speaker Change: And lastly, we're focused on improving continuity of care for lupus nephritis patients by growing our hospital business and keeping patients on therapy for longer periods of time.
Speaker Change: We're very pleased to start 2025 in a solid position with a highly efficient organization focused on loop kind of <unk> growth and therefore expect total revenue for 2025 and in the range of $250 million to $260 million and net product sales in the range of 240 to two.
Speaker Change: $250 million for 2025.
Speaker Change: Finally, we are also continuing to advance the development of our pipeline product that you are 200 or potentially best in class tools as April inhibitor for the potential treatment of a range of autoimmune diseases.
Speaker Change: We initiated a phase one study last September and expect to report our initial results from this study in the second quarter of 2025.
Speaker Change: I'd now like to turn the call over to Joe Miller, our CFO for a more detailed review of the fourth quarter and full year financial results. I'll. Then returned to end the call quote them for a quick wrap up and open up the line to any questions you might have Joe.
Joe Miller: Thank you Peter and good morning, everyone, let's take a few minutes to discuss the fourth quarter and full year 2020 for financial results.
Joe Miller: For the three months ended December 31, 2024, total revenue was $59 9 million compared to $45 1 million for the same period of 2023 for the year ended December 31, 2024, total revenue was $235 1 million compared to $175 5 million in 2023 at.
Joe Miller: As Peter mentioned, we had cash cash equivalents restricted cash and investments of $358 5 million as of December 31, 2024, and generated cash flows from operations of $44 4 million, we are continuing to be opportunistic with our share repurchase program and expect to fund any future discretionary share repurchases with cash.
Joe Miller: Cash flows from operations and cash currently on hand as of February 25, 2025. The company has repurchased approximately $9 7 million of its common shares for approximately $70 million since the launch of the program in the first quarter of 2024.
For the three months ended December 31, 2020 for cost of revenue was $5 6 million compared to $5 4 million in the same period of 2023 for the year ended December 31, 2020 for cost of revenue was $28 2 million compared to $14 1 million in 2023, the increase for the full year was primarily due to the amortization of.
Joe Miller: The finance right of use lease asset recognized in connection with the mono plant, which was placed into service in late 2023, and therefore, only partially impacted by prior year cost of revenue.
Joe Miller: For the three months ended December 31, 2024, gross margin was 91% compared to 88% in the same period of 2023 for the year ended December 31, 2024, gross margin was 88% compared to 92% in 2023.
Joe Miller: For the three months ended December 31, 2024, total operating expenses were $61 5 million compared to $74 8 million in the same period of 2023 for the year ended December 31, 2024 total operating expenses were $239 8 million compared to $267 2 million in 2023 the decrease in Boe.
Joe Miller: <unk> <unk> is primarily due to lower personnel costs, including share based compensation and overhead costs as a result of our strategic restructuring efforts in 2024, coupled with a reduction in non personnel R&D expenses as a result of ceasing development of the company's EUR 300 development program. These savings in both periods of park.
Joe Miller: We offset by a one time termination benefits contract terminations and other costs associated with our strategic restructuring efforts undertaken throughout 2024.
For the three months ended December 31, 2024, net income was 1.4 million or <unk> of earnings per share compared to net loss of $26 9 million or 19 <unk> of net loss per share in the same period of 2023.
Joe Miller: For the year ended December 31, 2024, net income was $5 8 million or four cents of earnings per share competitive compared to a net loss of $78 million or <unk> 54, a net loss per share in 2023.
Peter Greenleaf: With that I'd like to hand, the call back over to Peter for some closing remarks Peter.
Peter Greenleaf: Thanks, Joe and summary, Emperor implementing a highly focused industry, leading operational strategy has allowed us to lean further into the highest growth drivers for the commercial loop kind of business accelerate clinical development of EUR 200, and further strengthen our balance sheet. We now have more flexibility to engage in that.
Peter Greenleaf: Activities that can strategically enhance our business I want to thank you all for your time today, we'll now open the lines for any questions operator.
Speaker Change: Thank you well now be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad. The confirmation tone will indicate your line is in the question queue. You May press star two if you'd like to remove your question from the queue for participants using speaker equipment and may be necessary to pick up your handset.
Peter Greenleaf: We're pressing the star keys please.
Speaker Change: Please proceed with it.
Peter Greenleaf: One moment, please while we poll for your questions.
Peter Greenleaf: Okay.
Speaker Change: Our first question is from Stacy <unk> with TD Cowen. Please proceed with your question.
Speaker Change: Hi, Good morning. This is this for Stacy.
Stacy: Congrats on the year end. Thanks, so much for taking our questions. We had a couple.
Stacy: So thanks for talking about your kind of growth.
Stacy: Key growth drivers and so as we think about those in about 2025.
Stacy: Can you give us some more details around with.
Stacy: With the current sales force how you are maximizing the opportunity for <unk>, especially given the addition to the ACR guidelines.
Stacy: Maybe some more details on these prescriber segments and then.
Stacy: On the.
Stacy: The.
Then the second question is probably on the EUR 200 asset so we're really.
Stacy: Looking forward to the Q2 readout.
Stacy: Can you remind us what sort of data, we can expect and what we will be able to kind of clean alright for from it. Thank you very much.
Stacy: Okay.
Stacy: Thank you for the questions. Let me start with the first and then I'm going to ask Greg to jump in if I Miss anything on the second.
Stacy: First question on sort of post our restructuring maximizing the opportunity as it relates to.
Stacy: Kindness as we went through in the call I think we've.
We've got four key areas, we're focused on and then let me try to at least two or late two of those to how we address them post the restructuring. The first is a strong focus on rheumatology.
Stacy: As we all know L N patients or SLE patients that progressed to worsening outcomes and they present well they present, probably originally at a primary care physicians office, but once diagnosed there with a rheumatologist and if our goal is to drive the ACR guidelines.
Stacy: What they propose should be the treatment of the disease in the diagnosis of the disease initial diagnosis and initial treatment really should happen aggressively within the rheumatologist office. So as we restructured our group one of the things we put a very high priority on was focusing on high prescribing.
Stacy: <unk> SLE and L N.
Stacy: Offices, which we would pick up from both.
Stacy: <unk> codes.
Stacy: So we're actually looking at patient not actual patient, but patient chart. So that we're able to look at in a blinded fashion.
Stacy: So.
Stacy: The Rheumatol high prescribing rheumatology offices, one area hugely important guidelines you mentioned in your question hugely important since we know that there is an under diagnosis and an under treatment of the disease.
Stacy: And then lastly, we've focused our resources again against the hospital segment, because we know that major medical centers around the country that have lupus centers that are lupus centers and have lupus clinics are critically important to capturing patients early in their diagnosis, if they have elevated protein area.
Stacy: So just a few examples of how we've not just tightened our resources, but focus them down against two segments that we think are critically important.
Stacy: On your second question, which focuses on AUR 200, as you heard on the call. We're looking forward to disclosing what we see from our single ascending dose trial, that's ongoing and we'll beat out at the end of two Q this year.
Stacy: Think what you can expect to see our normal normal pharmacodynamics and normal pharmacokinetic data.
Stacy: Obviously in the April bass space. There are some important markers such as I G. G. I G. A I G. M that we would hope to be able to do show as well. This data is going to be critically important in understanding what dose we take into the Mad study and what structure, we actually used in that study as we prove.
Speaker Change: <unk> added the sad and then to the Mad dog.
Greg Keenan: I missed anything there did I Greg.
Speaker Change: Thank you.
Greg Keenan: Next question.
Speaker Change: Our next question is from Olivia Brayer with Cantor Fitzgerald.
Olivia Brayer: Hi, Good morning. Thank you for the question how are you all thinking about Luke harness growth beyond 2025, it looks like youre guiding to about 13% this year at the midpoint. So.
Olivia Brayer: Is it low double digits, the right way to think about growth rate. These next few years and then on EUR 200, well you guys actually be disclosing the dose for the Mad portion and indication selection in that second quarter update and is there anything you can tell us at this point about half life and potential dose frequency for your Canada.
Olivia Brayer: Right.
Speaker Change: Thank you Dan.
Greg Keenan: Thanks, Olivia so we havent historically and don't intend to today.
Speaker Change: Long term guidance on.
Speaker Change: But you can see what we've sort of centered or <unk>.
Speaker Change: Metrics upon and it's listen this product has been on the on the market now for poor going into its fifth year and we think those historical trends are the best way to think about the product on a go forward basis. So hopefully that's helpful.
On a EUR 200, and the sad data I will just hold back on saying, what we will or won't disclose because we access to see the data first.
Speaker Change: I think as we move into the Mad study it would probably be good and there'd probably be an expectation out there that will give some steer as to how we're going to conduct the mad, but I guess I would just add that we get the sad data first see what it shows us I think it will be really strong context for what we think.
Speaker Change: We have in this versus others that are also doing development in this space and then the next natural question is well how does that inform the Mad study, which.
Speaker Change: Or just a few months away from so look forward to having that conversation.
Speaker Change: Okay understood. Thanks, Peter well, what about in terms of timelines for obviously I know we have to see the sad data first but in terms of next steps and timelines for that Mad portion of the study.
Speaker Change: Can you guys put any kind of numbers or timelines around that.
Speaker Change: Yes, I guess I would go back to what I, just said, let us get the sad data first and then we'll we'll tell you what we intend to do into Madden that will inform how long that's going to take and what are what our projections are to completion of that so more to come.
Speaker Change: Okay understood looking forward to it thank you guys.
Olivier: Thanks Olivier.
Speaker Change: Our next question is from Farha and hate with Jefferies.
Speaker Change: Hi, This is on for Maury. Thank you for taking our questions two from us.
Speaker Change: One on the guidance just following off of it.
Speaker Change: The previous question you issued the guidance of $2 50, 240% to 50 and seems to be somewhat conservative given the <unk> run rate.
Speaker Change: What are you seeing in initial two months of this year, that's informed the commercial outlook for 2025.
Speaker Change: And then on exclusivity.
Speaker Change: The kinase has orange book publicity protection until January 26, if I'm not mistaken and as expected.
Speaker Change: N D. A was filed by Lotus earlier this months, maybe talk about your strategy there and is the base case assumption is steel.
Speaker Change: That the earliest generic can come to market in first half 'twenty eight.
Speaker Change: Yeah, Let me let.
Speaker Change: Let me start on the first question, which was our guidance range and what have we seen early in the year I think our guidance range is.
Speaker Change: As we said on the call very much driven by what we know now after our being in our fifth year on the market and looking very closely at our historical financial results and using that to sort of project out where we see the year.
Speaker Change: As you May see obviously, the low end of that projection is.
Speaker Change: Sort of flattish to slightly up versus where we were in Q4 at the higher end of that range.
Speaker Change: Obviously gets us into.
Speaker Change: Into a higher a higher growth category. So we feel good about the numbers across the board.
Speaker Change: Do we think they are conservative.
Speaker Change: We think there based on what we're seeing in the marketplace today on your second question.
Speaker Change: I think your point was.
Speaker Change: There was a little bit of a reiteration of some dates and times and.
Speaker Change: The the mid portion of 2028, I think we can reaffirm but I do want to just confirm for folks that were aware here. Obviously, we've been aware that anda filings will begin this year.
Speaker Change: We have a robust patent portfolio covering loop guidance for unique chemical entity and obviously is also the unique dosing paradigm.
Speaker Change: Which could take us all the way out to 2037.
Speaker Change: As any company would and we fully intend to do we fully intend to vigorously defend look guidance center intellectual property rights protecting the product so more to come as things continue to evolve here, but nothing's changed in terms of the dates and times.
Speaker Change: Thank you for the question.
Speaker Change: Thanks.
Speaker Change: Our next question is from Joseph Schwartz with Leerink partners.
Will: Hey, Al This is will for Joe today, Thanks for taking our question congrats on the progress this quarter. So just two from US I guess first could you just go back and talk a little bit more about your decision to no longer report SaaS for the final quarter in 2020 for I guess I'm just trying to understand why you might make that switch in the middle of the year.
Speaker Change: Other than something as you move forward in 2025, how should we be thinking about and trajectory.
Speaker Change: Trajectory of the launch about it looks like this and then one on <unk> hundred given it has a lower <unk> 50 as compared to other anti April assets is it fair to assume that the higher potency should allow for a lower or less frequent dose I guess when we're looking at the <unk> data. It looks like dosing was once weekly which is in la.
Speaker Change: With other assets. So can you help us understand this dynamic and the potential differentiation here versus other therapies in development. Thank you.
Greg Keenan: So I'll start with the first question and then ill ask Greg to jump in.
Greg Keenan: And obviously remind me more of a state of what we've reported not necessarily what speculative.
Greg Keenan: So as we said on the call. We're now five years into this and we're into our fifth year on the market. We believe confidently that our historical financial results provide enough insight sufficient insight into the health of our business to projected on a forward basis. We're.
Greg Keenan: We're excited to have grown our product more than 35%. This year in 2024, and we're guiding loop kindness revenues. This year at $2 40 to 250 and at a total company basis $2 $50 million to $260 million we.
Greg Keenan: We made the decision at year end, because we thought it was the best time, I think you mentioned midyear.
Greg Keenan: We actually believed that doing it now is what's the best time to do it and we look forward to reporting out on the key commercial strategy areas that I mentioned on the call and mentioned in the previous question as.
Greg Keenan: As we focused on them as our drivers for 2025 and beyond Greg you want to take the next one sure.
Greg Keenan: So you were referencing information that had been reported presented at the American College of Rheumatology meeting 2022 and what you alluded to was the fact that EUR 200 in the preclinical models that we.
Greg Keenan: Conducted.
Greg Keenan: Identify that there is a lower <unk>.
Greg Keenan: D and lower IC 50 lower means.
Greg Keenan: Resulting an equivalent impact with lower amounts of compounds, just like youre alluding to so we think that the potency of EUR 200.
Greg Keenan: With the work we've done thus far pre clinically is very attractive with regard to the <unk>.
Greg Keenan: Mt, a compound you'd need and perhaps the frequency with which you would need to give the drug that is less.
Greg Keenan: Milligram per milligram basis, and perhaps less frequent dosing of course, we're doing conducting a single ascending dose study right. Now has been as has been discussed earlier and in people will learn exactly what will be the take forward frequency of dosing and the milligram amount that would be appropriate.
Greg Keenan: And diseases that we select later so thanks for the question good information at this point and we're ready to move forward.
Ed Arce: Our next question is from Ed Arce with H C Wainwright.
Ed Arce: Hey, guys. Thanks for taking my questions two from me.
Ed Arce: Firstly.
Ed Arce: Yes.
Ed Arce: Wanted to ask again.
Speaker Change: On the ACR treatment guidelines as you mentioned one of the key drivers or continuing growth wanted to get your perspectives on.
Ed Arce: Uh huh.
Ed Arce: Your thoughts on the impact of prescriber perspectives.
Ed Arce: And ultimately their script, writing and uptake of loop kindness.
Ed Arce: Especially since.
Ed Arce: Historically.
Ed Arce: Script, writing from Rheumatologists.
Ed Arce: Been a bit more difficult to penetrate.
Ed Arce: Prologis.
Ed Arce: And then secondly.
Ed Arce: With regard to.
Ed Arce: AUR 200.
Ed Arce:
Ed Arce: Just wondering if you could.
Ed Arce: Help us understand.
Ed Arce: Use me.
Ed Arce: But as you think about the timeline coming out of the side and then.
Ed Arce: Later this year into the Mad studies.
Ed Arce: Whats the longer time.
Ed Arce: The longer term timeline look like as you think about ultimately selecting an initial indication and moving into in the early phase II.
Ed Arce: <unk>.
Ed Arce: Thanks, Good question Ed.
Ed Arce: The ACR treatment guidelines to oversimplify for folks on the call. The two biggest areas in there they really are.
Ed Arce: Quickly three that we see as being.
Ed Arce: Hugely beneficial for the market.
Ed Arce: Treatment patients and.
Ed Arce: Physicians one is early early diagnosis and treat to target guidelines basically do proteinuria screens on every patient that has SLE when they entered the office there and Thats, a rheumatologist office that doesn't happened today.
Ed Arce: When they hit a target level, you PCR to treat and we know today that somewhere around when.
Ed Arce: When they hit those target levels, only 30% of those patients even get treated huge opportunity and then lastly, regardless of the product that they're on that they need to be kept on that product for up to three to five years and we know today that no matter what the product is there is more of a mindset too.
Ed Arce: Three.
Ed Arce: Two a time period, where the.
Ed Arce: Proteinuria goes down and then selectively potentially they remove medication, which we know from our from our data that patients have to be restarted on the products. So all three of those are benefits too.
Ed Arce: Patients with al and the overall market and of course, our product so impact on behaviors. What I can tell you is greater than 50% of our prescriptions today come from Rheumatologists and that number is slowly growing.
Ed Arce: We have not seen massive change at least in the macro data that we have in terms of earlier diagnoses, yet, but we have to recognize that the ACR guidelines only came out in November. So I think there is plenty of time ahead, where these guidelines along.
Ed Arce: With the <unk> guidelines and the <unk> guidelines are all very positive for the L end market going forward and our product. So we will look forward to reporting numbers on market Ed as we go forward, but that's the high level, we're seeing some impact and we look forward to seeing more impact.
Ed Arce: <unk>, an actual treatment and diagnosis behaviors moving forward.
Ed Arce: In terms of your question on AUR 200 time.
Ed Arce: And once we get out of this AD into the Mad are longer term timelines well, what I would say is let us get through the single ascending dose trial, let us articulate what our approach to the multi is going to be and I think that will whether we give guidance for longer term or not.
Ed Arce: Got it will at least give some steer towards where we're going and how long that might take but I think we got to get through this sad, it's not far away look at what those kinetics and dynamic data tell us and use that as an informed decision to move into the match study so more to come. Thank you for the questions.
Ed Arce: Yeah.
Speaker Change: Thank you. This concludes our question and answer session I would like to hand, the floor back over to Peter Greenleaf for any closing comments.
Speaker Change: I want to thank you all for joining US today, we look forward to a strong 2025, and we will keep you updated along the way have a great day folks.
Speaker Change: This concludes.
Speaker Change: Today's presentation you may disconnect your lines at this time, thank you for your participation.