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spk04: Ladies and gentlemen, thank you for standing by. Good morning and welcome to the Lamb Air Sciences third quarter 2022 financial results in corporate update conference call. This time all participants are in listen-only mode. If you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone PCAD. To call your question, please press star then two. on this call are advised that the audio of this conference call is being broadcast live over the internet and is also being recorded for playback purposes. A webcast replay of the call will be available approximately one hour after the end of the call through January 26, 2024. I'd like to turn the call over to Scott Gordon of CoreIR, the company investor relations firm. Please go ahead, sir.
spk01: Good morning. Thank you, Nick, and thank you all for participating in today's conference call. Joining me from Alamira's leadership team are Rick Eiswer, President and Chief Executive Officer, and Russell Skibstead, Chief Financial Officer. During this call, management will be making forward-looking statements, including statements that address Alamira's expectation for future performance or operational results, future financial position, outlook, and guidance, and timeline for achieving positive cash flow. Forward-looking statements involve risks and other factors that may cause actual results to differ materially from those statements. For more information about these risks, please refer to the risk factors described in Alamira's most recently filed periodic reports on Form 10-K and Form 10-Q, the Form 8-K filed with the FCC today, and Alamira's press release that accompanies this call, particularly the cautionary statements in it. Today's conference call will include references to adjusted EBITDA, which is a non-GAAP financial measure. Please see the explanatory language and reconciliation table located in Alamara's earnings press release. The content of this call contains time-sensitive information that is accurate only as of today, October 26, 2023. Except as required by law, Alamara disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call. It is now my pleasure to turn the call over to Rick Eisworth. Rick, please go ahead.
spk05: Thank you, Scott, and good morning to everyone on the call. I'm excited to share our third quarter results, which demonstrate the leverage created by adding UT to our portfolio earlier this year. We achieved record net revenue in the quarter of $23.4 million, up 72% over the third quarter of last year. driven by the sales growth of our two brands, Illuvian and Utique. And importantly, we achieved positive $5.4 million in adjusted EBITDA in the third quarter. In the U.S. segment, we saw third quarter net revenue increase 103% to approximately $18.1 million year over year. Utique contributed $8.9 million to the quarter and continues to demonstrate significant growth with end-user demand reaching 1,045 units. an increase of 20% over Q3 of 2022. Illuvium returned to growth with end user demand of 1,146 units for the quarter, an increase of 8% year over year. We believe there is a significant opportunity to grow sales of both Illuvium and UT moving forward in the US behind our expanded sales force detailing both products and our other additional field personnel. As we shared in August, our larger team which represents over an 80% increase in reps detailing Utique and over a 20% increase in reps detailing Alluvium, began promoting both products in late July. We're still in a learning curve for our team, all who have taken on a new product. Continued training for both products is very important to our success. We held a launch meeting in July with all field employees and follow-up training in September. And we plan to continue to provide more medical and sales education in the field to further their knowledge and to increase their value to our customers. I think we will continue to get better across both indications. And this is important because we believe there is a significant opportunity to cross-sell the second product to many physicians that use only one of the two products today. For example, in the third quarter, only 27% of the accounts ordering either Utique or Alluvian in the third quarter ordered both Utique and Alluvion. This creates a significant opportunity for us moving forward. Turn to our international segment. We reported 5.3 million in net revenue during the third quarter, an increase of approximately 13% year-over-year, driven by a return to growth in Germany and continued strong performance in our other direct markets. In our direct European markets, we saw significant end-user demand growth of 20.4%, over Q3 of 2022. However, end user demand in our international segment was down 2% for the quarter, caused by the rationing of stock by our distributor partners during the quarter. As you may have seen, we were pleased to have Jason Werner, who has an extensive background in ophthalmics and significant experience in previous roles in commercial development and corporate strategy, join us as Chief Operating Officer early last month. We're already increasing our investment in this area, and Jason is working with our distributor partners and our manufacturers to improve inventory levels. We do expect to have stocking levels at the distributor partners addressed early in Q1 next year with improvement over the course of Q4. As we continue to pursue the increased utilization of Alluvian and UT, we expect that the sharing and discussion of additional data with physicians will be a significant driver. We continue to believe that the Paladin data set including improvement in visual outcomes, reduced treatment burden, and control of retinal thickness variability is an excellent marker for our new day study outcomes. As a reminder, the Paladin study demonstrated that patients with diabetic macular eczema who received a single dose of alluvium demonstrated statistically significant improvements in best corrected visual acuity, central subfield thickness, and treatment burden at 36 months, as well as demonstrating that the side effects risk of interocular pressure can be effectively mitigated when Alevian is used in accordance with its FDA label. This month alone, at the recent Uretina meeting in Amsterdam, we had four presentations of this data. And in New York at the Retina Society, we had an additional four presentations. Next month, at the American Academy of Ophthalmology in San Francisco, another presentation and three posters will highlight the efficacy and safety of Alevian from this study. From a clinical standpoint, we have several ongoing trials designed to further demonstrate the effectiveness of Alluvian and UT. Our over-enrolled New Day study, evaluating Alluvian's utility as baseline therapy head-to-head versus the leading anti-VEGF in the treatment of diabetic macular edema, has completed enrollment 306 patients and remains on track with top-line data anticipated in the first quarter of 2025. We are actively enrolling patients in our synchronicity study, which is a prospective open-label clinical study evaluating the safety and efficacy of UTIC for the treatment of macular edema associated with chronic noninfectious uveitis affecting the posterior segment of the eye and related interocular inflammation. This is a two-year follow-up study with an interim top-line six-month efficacy readout anticipated in the third quarter of 2024. Additionally, we've completed enrollment in the UTIC CALM study with 240 eyes. The CALM study is a registry study conducted in collaboration with the Cleveland Clinic, collecting real-world data to better understand the variety of conditions treated with UT for noninfectious uveitis affecting the posterior segment of the eye. We expect efficacy outcomes on individual and combined patient cohorts to be presented at medical conferences in 2024. Also with Alluvion, we are working with the DRCR Retina Network to support protocol AL Protocol AL is a randomized clinical trial evaluating either intravitreal furosemab injections or alluvian intravitreal implants versus observation and the prevention of visual acuity loss due to radiation retinopathy following plaque brachiotherapy. Looking to the future, we are actively evaluating indication expansion opportunities to broaden the number of patients that either alluvian or UT as long-acting stereo implants can help treat. We look forward to sharing further details in the coming months. And with that update, I'll turn the call over to Russell to review our third quarter financial results in greater detail.
spk07: Thanks, Rick. And hello, everyone. Thanks for joining us today. I am also very happy to report that net revenue is up 72% to approximately $23.4 million in Q3 2023. which was almost $10 million more than the 13.6 million we reported in the third quarter of 2022. The increase was due to the addition of UTiQ into our US portfolio combined with organic growth in alluvium sales in both our US and international markets. Total end-user demand for alluvium and UTiQ during the quarter was up 233 units to 3,456 units over the 3,223 units for the same period last year. Net revenue in the U.S. increased 103% to approximately $18.1 million in Q3 23. This compared to U.S. net revenue of $8.9 million in Q3 22. The growth was attributable to growth in alluvian sales year over year as well as the addition of UTiQ. U.S. end user demand for Alluvian and UTiQ during the quarter was up 260 units to 2,191 units over the 1,931 units for the same period last year. International net revenue also performed well, increasing 13% to approximately $5.3 million in Q3 23. This compared to approximately $4.7 million in the third quarter of last year. Growth in revenue was due to the increased sales in our direct markets, as Rick alluded to, where we received higher net revenue per unit. International end-user demand for Alluvian during the quarter was down 27 units to 1,265 units over the 1,295 units for the same period last year. Total operating expenses were approximately $18.8 million for Q3-23, which compared to $15.0 million in the same period last year. This increase was primarily due to the increased operating costs associated with the addition of UTIC in the U.S. segment and depreciation and amortization associated with the assets acquired. We received record adjusted EBITDA of $5.4 million in the quarter. This compared to an adjusted EBITDA loss of $2.5 million in Q3 23. As of September 30th, 2023, we had cash and cash equivalents of approximately $8.3 million compared to $18.8 million on June 30th, 23. Cash burn during the quarter was primarily a result of working capital investments required to support the addition of UTIC during the quarter. What this means is that in May, we began paying all of the expenses for UTIC, but because of the payment terms with the distributors, we did not begin collecting on those sales that we made until this month. We expect to generate positive cash flow in the fourth quarter of 23 and in 2024. With that, I will now hand the call over to Rick so he can give us closing comments.
spk05: Rick. Thank you, Russell. I commented on our last call that we are committed to leveraging our existing U.S. commercial infrastructure to achieve sustainable, positive EBITDA beyond this year. This quarter was solid evidence that our strategy is working. We're also committed to growth and to support the significant revenue opportunities provided by both Olivia and UT. In 2024, We will look to leverage our broader commercial team and stronger financial position to increase our engagement with retina specialists, leverage the cross-selling opportunity presented by having two products and indications, and drive utilization of both products. As I noted earlier, we will evaluate indication expansion opportunities for our long-acting steroid implant to help more patients. This quarter was the first step in establishing a foundation to achieve our goals next year. And we are reiterating our expectation to generate more than $100 million in revenue next year and at least $20 million of adjusted EBITDA in 2024. We will endeavor to update our revenue and EBITDA guidance as we progress through the integration and planning for 2024 with a goal to improve these targets. This concludes our prepared remarks, and I'll now turn the call over to the operator for questions.
spk04: Thank you. Ladies and gentlemen, if you wish to ask a question on today's call, you'll need to press the star number one on your telephone. If your question has been answered and you wish to withdraw your request, you may do so by pressing the star and then the number two. If you're using a speakerphone, please pick up your handset before ending your request and speaking on the call. One moment, please, for the first question. First question will be Alex Novak. Craig Hallam, please go ahead.
spk03: All right, great. Good morning, everyone. Thanks for doing the call here. You know, that 27% cross-sell number that you mentioned in the prepared remarks, where can that realistically go by the end of the year? I think that's a really important metric here as you complete the combination of the two assets.
spk05: You know, Alex, I mean, that's a really hard one to project. I mean, I will say it's up a point or two, you know, since we took over the both products. So I think you're certainly seeing some impact there early, but I wouldn't expect to see major strides of that until we get into next year as we continue to get the entire team cross-trained really well across both products.
spk03: Okay. So next year, with all this kind of training in place, then we can start to see that number climb up. That makes sense. Maybe expand a little bit on the OUS weakness there. I know you touched on it during the prepared remarks, but I was surprised seeing the OUS units decline quarter over quarter in such a dramatic fashion. Just expand on what was happening over in Europe this quarter.
spk05: Yeah, sure. So, you know, as we talked a little bit about on the second quarter call, you know, we have been a little bit behind in supplying some of the distributors in Europe. You know, that's a factor of demand increasing in our other markets. And, you know, frankly, the early forecasting in the first part of the year from the distributor partners was, and late last year, was lower than expected. And we just have a long lead time product for manufacturing. So we actually were really pleased with the demand growth in the direct markets. As we noted, they were up over 20%, I think 20.4%. What happens in some of the markets in Europe is if they are low on stock, they have to ration the units going out so that they don't go out of stock. And so our partners in in France specifically has had to, based on working some things out with the regulatory authorities, you know, lower the number of units that they're shipping each quarter in order to just maintain an in-stock position. And so that's what I mean by rationing that. So we do expect that to, you know, have a significant uptick back to levels they were at before, you know, once their stock has built up. And as I said in my, you know, prepared comments, you know, we're working closely with them to rebuild stock over the course of the fourth quarter and think we'll be back to the point where they'll be fully stocked in Q1.
spk03: Okay. That makes sense. With regard to the U.S., we had some choppiness in the past couple quarters with docs trialing new drugs, and that was essentially slowing the rate that they're moving over to Alluvian. Just thoughts on longer-lasting anti-VEGF drugs, the thoughts on how docs are trialing, retina docs are trialing new drugs out there. It seems like that has reversed this quarter. Is that fair to assume?
spk05: Yeah, a little bit of it. I mean, I do think, you know, the trial of fericamab out there, you know, is still a formidable, you know, it's a challenge to us as we go forward. But, you know, I think the reality is doctors are learning as they trial fericamab that it is, and this isn't to say anything negative about it, it is anti-VEGFs are a class of drug, right? And the reality is that there are patients out there that need something more than anti-VEGF therapy. It's been demonstrated in, you know, DRCR protocols that there's persistent edema in these patients even they receive you know, recurring and barely tightly spaced doses of anti-VEGF therapy. So, I think we, you know, we will work through that, but, you know, the use of versamab is still pretty aggressive now, but there's still a need for the steroid to take the place of those anti-VEGFs in certain patients.
spk03: Okay, got it. And then just two more questions, if I can. Just the first one on, you know, the New Day study, I think we all know that's a very important study for lovian Maybe expand a little bit on the differences between the two UTIC studies and just how can those outcomes there, how would that start to change adoption in the market? Like, is it the same level as New Day or are these more confirmatory studies?
spk05: Yeah, so I'll start with CALM. You know, so CALM is a registry study to collect real-world evidence on the use of UTIC in, you know, treating noninfectious posterior uveitis. I guess one of the challenges of the pivotal studies was there were no cohorts defined to look at specific types and specific cases of uveitis. And there's probably 25 to 30 different types of uveitis that are studied and treated in the back of the eye. So the idea is to hopefully develop some cohorts in the more specific types where alluvian or an anti-inflammatory steroid would be used, you know, locally more effectively. And we hope to get that out of the CALM study. And we should continue to be able to produce some of that next year. There are also some consensus papers, you know, coming out of Europe that will talk about specific types of uveitis where a long-term acting steroid is, you know, more applicable as well. So I think it'll help doctors with patient identification earlier in their evaluation of uveitis in those patients. The synchronicity study is really, it is very, very similar to the pivotal studies. However, the focus is around the more traditional retina specialists and the type of uveitis that they may treat that doesn't get referred out to the uveitis specialists. So one example of that is You know, postoperative inflammation, a lot of times when physicians look at that, there are characteristics of uveitis in that, right? And that's maybe a direct result of vitrectomy surgery or cataract surgery. And a patient with postoperative inflammation is referred to that retina specialist. And so it's to identify the types where uveitis is present in those eyes because they've developed some sort of long-term inflammation, you know, in those types of situations. Or maybe a less severe type of uveitis, as I said, that is just going to be treated typically by the retina specialist.
spk03: Okay, very helpful. Last question, guided to 20 million adjusted EBITDA. You confirmed that again this morning for 2024. But it also looks like you're almost at that run rate to begin with in Q3. When do we start to up that target for next year?
spk05: As I said, we are, Alex, we're very bullish on next year. You know, we do want to work through some of the rest of the pieces of the integration. As I said, we made a lot of progress there in some of our plans for 2024 before we update that guidance. I do think there are some places where we have been very conservative in, you know, spending in Q3. to make sure we could get the integration right and waiting for the working capital to turn, as Russell alluded to. But we do want to make sure we maximize the effort next year in getting in front of doctors and this cross-sell opportunity, as well as looking at some opportunities to expand that label with potentially other indications. So right now, we're going to stick with over $100 million and over $20 million, but we'll give you updates on that as we move into the next year.
spk03: All right, excellent. Thanks for the update. Appreciate it. Congrats on all the progress. Thanks.
spk05: Thanks, Alex.
spk04: We appreciate your support. Thank you. Next question will be from H.C. Wainwright. Please go ahead.
spk08: Thank you for taking my questions. My first question is, do you plan to add additional sales reps throughout 2024?
spk05: Yee, thanks. Good morning to you. That's a good question. I mean, right now we are only, you know, three or four months into having the team of 35 out there. So we want to see how productive and effective they are, you know, first. Obviously, you know, if more face-to-face time at the rep level, you know, does yield positive benefits in 2024, I think we will continue to evaluate, you know, the potential to expand the sales force. But no decision has been made on that at this time.
spk08: Got it. Got it. And could you comment on the percentage of international revenue that's represented by your direct sales force?
spk06: Yeah, I've got that. I'm going to say direct is roughly two-thirds of our total.
spk07: Distributors is roughly one-third of our international sales.
spk08: Okay. Got it. And lastly, in the coming quarters, do you expect any seasonality in terms of boutique sales? Yes, I think.
spk05: Sure, yeah. I think you're going to continue to have seasonality. in the first quarter related to, you know, these are both high-priced products. So in the U.S., you know, the vast majority of patients start their deductible years over as of January 1 with, you know, new insurance plans or slight modifications in their insurance plans. So We always see quite a delay in January and February as doctors try to re-evaluate or redo benefit investigations to make sure the insurance coverage is there. I think that's pretty typical with some higher-priced products in the space. You also see a little bit of seasonality in the first quarter. Some of the budgets in Europe are reset as they reset their budgets. And then we often do see seasonality in Q3 as well related to, you know, European holiday season and also holiday season in the U.S., you know, in the third quarter also seems to impact it as well.
spk08: Thank you very much.
spk04: Yep, absolutely. Thank you. Thank you. Our next question will be from James Malloy of Atlas Alliance Global Partners. Please go ahead.
spk02: Hello, this is Laura Sorrell calling in for James Malloy. Thank you for taking our questions. So for your net revenue this past quarter reported at, you know, 23.4 million, what's the specific breakdown of this value between both UT and Olivia and product revenues?
spk05: Well, I think we, in Russell's comments, he noted that about 8.9 million of that was from UT.
spk02: Okay, got it. And then also looking ahead, you mentioned that you're on track to deliver. over $100 million in net revenue for, you know, next year, 2024. May you just provide a bit more guidance on how this, you know, would be broken up again between both products, both in the U.S. and internationally?
spk05: You know, as we noted in the release and some of the comments, you know, our plan going forward is to really report the flucinolone acetanide franchise on a combined basis. So we're not going to break out specific guidance on that. I mean, frankly, we benefit from increased usage of a long-term low-dose steroid in any indication, and we're still working out where the focus of the promotion would be next year on that. But overall, we're very confident with the $100 million number.
spk02: Got it. And then lastly, your share count now at $32 million for this past quarter. Can you just provide a bit more detail on the jump in the number here in comparison to, you know, this past second quarter at 8 million?
spk07: Yeah, right now we're at about 53.4 million shares of common outstanding.
spk02: All right. And then also, all right, last question from us. Just any more updates on the ongoing protocol AL trial that you had and then just a first look into the data when that might come out?
spk05: That's a pretty lengthy trial. I mean, that's, it's the target the DRC has on the trial is about 600 patients. You know, we're hoping that they will start enrollment in the, late in the fourth quarter of this year. but it's probably a multi-year trial before you'd see any readout. It's being run by the DRCR, so we don't control the timeline on that trial.
spk02: Yeah, I understand. Okay, so that's all for us for now. Thank you for taking the questions.
spk04: Great. Thank you, Laura. Thank you. And again, if you have a question, please press star then 1. This concludes our question and answer session. I'd like to return the call to Mr. Rick Iveworth for closing remarks.
spk05: Thank you. I want to thank everybody for participating on today's call and for your interest in support of Alamira. We do look forward to sharing our ongoing progress when we report fourth quarter and full year 2023 results early next year. Thank you all very much and have a great day.
spk04: Conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
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