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spk06: Ladies and gentlemen, thank you for standing by. Good morning and welcome to the Alamara Sciences fourth quarter and fiscal year 2023 financial results and corporate update conference call. At this time, all participants are in a listen-only mode. Should 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 keypad. To withdraw your question, please press star then 2. Participants on this call are advised that 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 June 7, 2024. I would now like to turn the call over to Scott Gordon of CoreIR, the company's investor relations firm. Please go ahead, sir.
spk05: Thank you, Scott. Good morning, and thank you for participating in today's conference call. Joining me from Alamara's leadership team are Rick Eiswert, President, Chief Executive Officer, and Elliot Maltz, Chief Financial Officer, and Todd Wood will be joining us, President, UBS Operations, in the question and answer session today. During this call, management will be making forward-looking statements, including statements that address Alamara's expectations 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 Alamara's most recently filed periodic reports on 410Q, will form 8K filed with the SEC today and form 10K to be filed with the SEC from the year end of December 31, 2023, as well as 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 Alamira's earnings press release. The content of this call contains time-sensitive information that is accurate only as of today, March 7, 2024. Except as required by law, Alameda 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 Eisler. Rick, please go ahead.
spk00: Thank you, Scott, and good morning to everyone on the calls. 2023 was a pivotal year for Alamira. We exited 2023 much stronger than we came into it. In 2023, we accomplished many goals. We completed a strategic and transformative transaction to obtain the commercial rights critique and expand our product portfolio. We strengthened our balance sheet and simplified our capital structure. We established the critical mass to drive positive adjusted EBITDA moving forward, as well as operating cash flow in 2024. We expanded our commercial team to drive growth and utilization of both products. And we completed the enrollment in both our two Phase 4 clinical studies, New Day and Synchronicity, that we expect will drive increased utilization of both Alluvian and UTEEQ in future years. As we head into 2024, we see the benefits of these transactions that we completed in 2023. We acquired UTEEQ to consolidate the rights to the flucinolone and setinide in-plant technology in the U.S., and expand the indications available for us to serve patients with retinal conditions. Now that we have both Alluvian and Utique in the U.S., we believe that there is significant opportunity to increase their utilization. In 2023, we learned that fewer than 30% of legacy Alluvian and Utique accounts utilize both products. With our expanded sales force selling Alluvian and Utique in the U.S., and our marketing of the two indications as the same long-term, consistently delivered, low-dose technology provides durability that both our physicians and patients want today in a product. We believe the opportunity to allow physicians to treat a broader array of patients is tremendous. We spent the back half of the year incorporating UT into our U.S. business, training our commercial team to sell both products and promote both indications. We made significant progress with utilization of our products and the second half of 2023 up 9% over the second half of 2022 on a pro-clima basis. With the acquisition of UT and the continued growth of Alluvium globally, our financial results have improved significantly in 2023. In Q4, our consolidated global net revenue grew 88% over Q4 of 2022 to $26.3 million. And for the year, our net revenue grew 49% over the full year of 2022 to $8.8 million. Importantly, as we projected, we are driving positive adjusted EBITDA in cash flow from operations now that we have critical mass with a larger portfolio. Our adjusted EBITDA in the fourth quarter was $5 million, a significant improvement over Q4 2022 when we had an adjusted EBITDA loss of $1.2 million. For the full year of 2023, we delivered positive adjusted EBITDA of $8.7 million, compared to a loss of $7.9 million in 2022. In our U.S. segment, net revenue in Q4 2023 increased 104% to $19.2 million versus $9.4 million in Q4 of 2022. This contributed to a 66% increase in U.S. revenue for the full year of 2023 to $56.7 million. U.S. end-user demand for our products was up 4.4% in Q4 versus the prior year and 11% on a pro-forma basis for the full year. Although we have made great commercial strides with the integration of UT and the UBI syndication, we believe we still have a significant opportunity ahead of us to maximize the benefits of selling two high-priority products. To help accelerate growth in 2024, Todd Wood joined our team in December as president of our U.S. operations. tottering the wealth of experience with the successful brands such as Botox and Lumigan, and will be joining us on the call for the Q&A session. We believe our international business, where Illuvium has both indications under one brand, is a great leading indicator of what is possible in the U.S. Our international business grew significantly in both Q4 and for the full year. In Q4 2023, international net revenue grew 54% to $7.1 million. and for the full year, net revenue was up 21% to $24 million. We experienced a 16.7% end-user demand growth in Q4 and 11.8% for the full year in the international segment, driven by increasing end-user demand in our markets of the UK, Portugal, Ireland, Spain, and France. Revenue from our distributor partners was also up for both the quarter and the full year. However, due to limited supply capacity, we were not able to fulfill all of the end user demand in the second half of the year after being up over 30% through the end of the second quarter. Moving into 2024, we believe we will no longer be faced with these supply issues. In Q4, Jason Warner joined our team as Chief Operating Officer, and we have made and continue to make additional investments to ensure available manufacturing capacity moving forward. As a result, We made significant distributor shipments in the fourth quarter of 2023 and anticipate meeting end-user demand in Europe in a timely manner moving forward. We expect the international business to continue to be a significant contributor to our growth, and we anticipate growing utilization of the UBI syndication in those markets as we introduce some of the positioning we have adopted following the acquisition of UT in the U.S. When Jason joined us, I was pleased to name Dr. Philip Ashton, who has been with us the past 10 years, as the President of International Operations, allowing Philip to spend 100% of his time focused on execution and growth of the international segments, both on our direct markets of Germany, the UK, Portugal, and Ireland, but also in supporting our distributor partners throughout Europe and the Middle East. In February, we announced that the UK National Institute for Health and Care Excellence, or NICE, has issued final draft guidance recommending that chronic diabetic macular edema or DME patients with a natural lens, also known as phasic patients, have access to alluvium. NICE reimbursement to date has been limited to only pseudophatic patients, defined as those who had undergone cataract surgery, which is less than a third of the population. Now we have the potential to reach phasic patients who advanced to chronic DME, a significant expansion of our potential user base. We expect the availability of this wider reimbursement to positively impact utilization in the UK in the second half of 2024. This limitation has historically impacted reimbursement in other countries as well, such as Spain and Italy, which looked to the NICE guidance as a contributing factor in the reimbursement decisions. We believe that this NICE decision, if adopted in other markets, will broaden our potential patient base in these countries as well. In previous calls, I've shared that our goal for 2024 following the UT transaction was to achieve $100 million in consolidated revenue and annual EBITDA margin of 20%. As a result of our success in the second half of 2023, we are revising our financial guidance for 2024 revenue to exceed $105 million in revenue with an adjusted EBITDA margin of 20% for the year. We do expect our business to fluctuate quarter to quarter due to the seasonality of our business. Historically, we've seen lower revenue in Q1, primarily resulting from the new insurance year with the resetting of patient deductibles, which dampens utilization of high-priced products like aluminum boutique in January and February. Historically, Q1 revenue has been 10% to 15% below the previous quarter, and we would anticipate the same impact in Q1 of this year. Adjusted EBITDA will also fluctuate quarter to quarter as a result of this seasonality, but we are confident in our ability to deliver 20% margins annually. We are pleased to also have completed enrollment in two phase four studies that we believe will provide impactful data and drive increased physician utilization in the future. In June, we finished enrollment in our landmark New Day study with 306 patients. The New Day study is evaluating lupine's utility as early baseline therapy in naive or near-naive patients, and a head-to-head study versus the leading anti-VEGF in the treatment of diabetic macular edema. This study is the first head-to-head comparison of long-term low-dose corticosteroid therapy versus anti-VEGF therapy in the treatment of DME. And we believe that it's successful to change the treatment paradigm for DME by moving a long-acting steroid implant earlier in the patient journey. The last patient's last visit in this study is projected for Q4 of this year, and we anticipate having data in early 2025. In January, we announced the completion of enrollment in the Synchronicity Study, which is a prospective open-label clinical study evaluating the safety and efficacy of UT for the treatment of macular edema associated with chronic noninfectious uveitis affecting the posterior segment of the eye and related intraocular inflammation. This study's purpose is to gain broader insight into the use of UT by the general retina specialist in real-world clinical practice, as opposed to those who practice solely as UVI specialists in a trial. This is a two-year follow-up study with an interim top-line six-month efficacy readout anticipated in the second half of this year. And with that update, I will now turn the call over to Elliott to review our fourth quarter and fiscal year financial results in greater detail.
spk02: Thanks, Rick, and hello, everyone. I'm very pleased to have joined Almera at such an exciting time. Look forward to continuing discussions with you all. I'll take you through the numbers and then give a brief financing update. Consolidated net revenue in Q4 2023 was up 88% to approximately 26.3 million compared to 14 million in Q4 2022. Looking at our operational segments, U.S. net revenue increased 104% to approximately $19.2 million in Q4 2023, compared to $9.4 million in Q4 2022. End-user demand in the U.S. for our Fluocinolone implants was 2,065 units in Q4 2023, which is up 4.5% compared to Q4 2022 on a pro forma basis. International net revenue increased 54% to approximately $7.1 million in Q4 2023, compared to approximately 4.6 million in Q4 2022. The increase was driven primarily by end-user demand growth of 17% in our direct markets and stocking shipments to our international distributors that were more than double our Q4 2022 results. Total end-user demand in our international segment was 1,464 units, which is down about 6.5% compared to Q4 2022 due to limited inventory in our distributor markets of Spain and France during the quarter. However, as Rick noted, this was a result of limited supply in the second half of the year that has been addressed prospectively. Now looking at the full year 2023, consolidated net revenue increased 49% to approximately $80.8 million compared to approximately $54.1 million in 2022. The increase in 2023 was primarily attributable to one, the acquisition of UT in the United States in May, and two, strong growth throughout the year in our international segment. U.S. net revenue increased 66% to $56.7 million in 2023, compared to $34.2 million in 2022, due to the acquisition of UTEC in May, as well as the continued growth of Alluvia. In our international segment, net revenue increased 21% to approximately $24 million in 2023, compared to approximately $19.9 million in 2022. We saw notable growth throughout the year in the European markets where we saw alluvium directly, specifically the UK, Portugal, and Ireland, as well as Spain and France where alluvium is sold through international distribution partners. Overall, international segment end user demand was up 7% to 5,583 units compared to 5,211 units in 2022. Now, looking at the rest of our P&L, total operating expenses in the fourth quarter of 2023 were approximately $21.1 million compared to approximately $14 million in Q4 2022. The increase in the fourth quarter of 2023 was negatively impacted by one-time charges of approximately $1 million for bad debt expense related to pre-COVID sales to one of our European distributors and approximately half a million of severance expense. When comparing Q4 2023 with the prior year, there was also an additional $2.4 million of amortization expense from the intangible assets that resulted from the UTEC acquisition. Total operating expenses for the full year 2023 were approximately $72 million, compared to approximately $58 million in 2022. The increase is due to the items I just mentioned, as well as the acquisition and staffing for UTEC. net loss was approximately 3.8 million in both Q4 2023 and Q4 2022, despite additional 3.1 million of interest expense in the fourth quarter of 2023. For the full year, net loss was approximately 20.1 million in 2023 compared to a net loss of approximately 18.1 million in 2022. We are pleased to continue the trend of generating positive quarterly adjusted EBITDA. And in Q4 2023, we generated approximately 5 million of adjusted EBITDA compared to an adjusted EBITDA loss of approximately 1.2 million in Q4 2022. For the full year, we generated approximately 8.7 million of adjusted EBITDA in 2023 compared to an adjusted EBITDA loss of approximately 7.9 million in 2022. As a result of posting this adjusted EBITDA for the full year, we have met an important trigger in the term loan agreement with our lender, SLR Capital Partners. This will allow for a 12-month extension of the interest-only period and defer the start of amortization payments to May of 2026, so long as you remain in compliance with the other terms of the loan facility. As of December 31, 2023, we had cash and cash equivalents of approximately $12.1 million, compared to $5.3 million at the end of 2022. In addition to the effects of generating positive adjusted EBITDA this year, our cash position was improved by the strategic financing transactions of 2023. As a result of the revenue growth this year, in December, we triggered 1.3 million of revenue-based milestone fees included in our term loans with SLR. And we expect to trigger the remaining 2.4 million in 2024. SLR continues to be a great partner. And in order to preserve cash for working capital as we continue to grow the utilization of Elluvian and UTEEK, yesterday, we increased the size of our loan facility for an additional 5 million in cash. This provides us with more operating flexibility and defrayed the impact of some of the upcoming contractual obligations. Now, I'll turn it back over to Rick to give his closing comments.
spk00: Thank you, Elliot. As I mentioned, 2023 was a pivotal year for Almeria with the acquisition of UT, providing the necessary critical mass to establish our financial stability for the future. And we think that the second half of 2023 is a great demonstration of our ability to leverage the infrastructure we've built in the retina space in the U.S. and in Europe. However, there is a significant opportunity to grow the utilization of olivine and UT in 2024 and beyond. We believe that calling on physicians and promoting two indications will provide greater recall value for retina specialists as they make treatment decisions. We believe that reach and frequency are critical in promoting Alluvian and Utique, and that we will be able to speak with more physicians more often in 2024 with our larger sales force being fully trained and in the field for a full year. We believe that carrying both Alluvian and Utique in one bag will help grow both brands as we are able to cross-sell the benefits of long-term, low-dose delivery for both indications to the same customer, increasing the likelihood of a customer considering using our products on more patients. We believe that the numerous studies we've conducted around the world with alluvium are a good indicator that the new day study will report a successful outcome and support the use of alluvium earlier in the treatment paradigm for DME. We believe the synchronicity study will highlight increased utility of UT in the general retina specialist practice. And for those and more reasons, we are bullish about 2024 and our ability to exceed $105 million in revenue with an adjusted EBITDA margin of 20% for the full year. Thank you. That concludes our prepared remarks, and I'll now turn the call over to the operator for questions.
spk06: Ladies and gentlemen, if you wish to ask a question on today's call, you will need to press star then 1 on your telephone keypad. If your question has been answered and you wish to withdraw your request, you may do so by pressing the pound key. If you are using a speakerphone, please pick up your handset before entering your request and speaking on the call. One moment, please, for the first questions. The first question today comes from Alex Nowak with Craig Helm Capital. Please go ahead.
spk01: Okay, great. Good morning, everyone, and very transformational 2023. You know, that cross-selling last quarter, it was cited at 27%. Right now it's around the less than 30%. Where can I realistically go here, you know, over the next several years? And then maybe for a question out there for Todd, So how can you think about utilization within the existing retinal specialists? How much can that grow as well?
spk00: So I guess I would comment first. First of all, Alex, thanks for the comments and your support. First of all, I'm going to say that, you know, with respect to the cross-cell, you know, you're never going to get 100% overlap there because you do have a population of specialists that treat only uveitis. But certainly, you know, I think we internally aspire to get that number up over 50%, you know, in the next 12 months if we can do that to drive revenue. Todd, do you want to comment on the other questions?
spk04: Yeah, yeah, Rick. And hi, Alex. How are you? Thanks for the question. Yeah, the crossover, I agree with Rick, right? We're not going to get all of it because they are a little bit different in terms of the focus of the specialty when we're looking at uveitis specialists. But if we can expand in the post-surgical inflammation area, With UT and get retina specialists looking at post-surgical inflammation as it is uveitis and there's a crossover there So it's going to be a little bit of work to doing that but I agree with Rick that 50% seems like a good number to get to We won't get all of it, but there's opportunity for crossover
spk01: And in the past, we've talked about there was trialing and new drugs in the DMA and likely the uveitis market as well. Just what's the latest on, I guess, more or less the competitive environment out there for both DMA and uveitis?
spk00: Yeah, I think in DMA, you are seeing, you know, some of the competitive aspect of, you know, a new entrant into the space in the second half of the year last year, you know, competing with another, you know, strong rival. And you are seeing You know, some sampling that occurred in the second half of the year that was pretty aggressive. So I think that has impacted us a little bit. But, you know, consistent with what we've seen in the past, you know, when a new anti-VEGF comes along, although there's trial, you know, in the end, there still seems to be that block of patients that comes through, you know, and needs really a corticosteroid, you know, to treat the broader inflammation in the eye that the anti-VEGF can't address. So although we lose patients for a period of time, you know, if maybe the trial of a stronger anti-VEGF, you know, those patients ultimately work their way through to us.
spk01: Yep, absolutely. And when can we expect top line data for the new day study?
spk00: It'll be sometime in early 2025. You know, last patient, last visit is in the fourth quarter. So, you know, probably toward the end of the first quarter, early second quarter in 2025.
spk01: Okay, got it. And then just two more questions. The first one really around, now that you have the global rights here to the product portfolio, Just the expansion on the R&D line, moving this into additional indications, maybe increasing the size of the current indications. What are your thoughts there?
spk00: Yeah, look, I think as we talked about on last call and set up today, you know, we are continuing to look at places where we can do some indication expansion. I think, you know, Cortica has been using that for 40 or 50 years. You guys have heard me say that before because they work, right? And there are other indications. You know, we have the protocol AL with the DRCR where we're looking at radiation retinopathy, and we've been having some advisory boards with doctors looking at some other potential indications, you know, that we could develop. As the New Day study and the synchronicity study roll off, we would probably redeploy that capital rather than see a big increase in our costs.
spk01: Okay, got it. And then just lastly, kind of a clarification. around the interest expense. It looks like it came in pretty high here for Q4. What's just a normal interest rate expense to assume for 2024 with the addition of the $5 million on top of it?
spk02: I can take that question. So we would expect a typical run rate to be around, you know, ballpark, let's call it, you know, $3.5 million on a quarterly basis. But this was adjusted in Q4 because we met one of the exit fee milestones with our loan agreement with SLR that triggered $1.3 million of additional interest expense. And we do anticipate triggering an additional $2.4 million of such contingent interest-related payments during 2024. So we do anticipate that over the first you know, six to nine months of the year, and then interest expense will again begin to normalize.
spk01: Okay, got it. I appreciate the update. Thank you.
spk00: Thank you, Alex.
spk06: The next question comes from the line of James Malloy with Alliance Global Partners. Please go ahead.
spk03: Hey, good morning, guys. Thank you very much for taking my questions. I was wondering if you could walk through sort of what message has resonated best with the docs here in the fourth quarter going forward, and how has that sort of changed over the year, if at all? And can you walk through how many reps you currently have working and how the retention has been through the year?
spk00: Yeah, so Todd may want to comment on this as well. I think, you know, we're in a big opportunity for us, especially now that we can talk about, you know, two indications, you know, the inflammatory diseases, uveitis and for DME. You know, a lot of the patients that are, you know, easy for us to go after are those that are already on Ozerdex, right? Because Ozerdex or Allergan has been promoting, you know, against uveitis and DMU for a while as well. And so there's just a broader group of patients there that we can go after. And so I think those conversations are, you know, a successful opportunity for us as we move forward and will continue to be in 2024 while we await the new day data and the you know, across the country right now. We've had sort of what we call the normal attrition. You know, we have some of the people that, you know, we have decided to turn over in the sales force. We have not had too many people leave to go to competitors or anything like that this year because I think we've got a pretty strong culture here. But, you know, we'll always have some turnover in the back half of that sales team. Todd, I don't know if you have anything you want to add to that.
spk04: Yeah, yeah, I'll add to that, Rick. And as Rick said, you know, Ozerdex is, you know, the target. There's opportunity to displace that competitively. And when we look at messaging and we look at our advocates of use, you know, they viewed the disease a little bit differently earlier, some more severe earlier, and then they link the effectiveness of our product to preserving vision and lowering your risk of losing vision. So we really need to leverage those two items and then really clarify where to position it so it gets positioned earlier in the treatment paradigm.
spk03: All right, great. Thank you. Then maybe a quick housekeeping. Maybe you touched on it in the repair doc comments already. What was the jump in G&A in the fourth quarter?
spk02: So there were a few items, one-off events during the fourth quarter. There was about a million of bad debt expense that we recognized in the fourth quarter that was related to pre-COVID sales of one of our European distributors. And then there was another half a million of severance expense that we recognized during the fourth quarter. Additionally, we had higher stock-based compensation expense, and this was a result of an equity grant to certain employees during the fourth quarter, which also drove a higher G&A bounce when you look at things quarter over quarter.
spk03: Okay. There's about 2 million or so of one-timers in the quarter?
spk02: Approximately a little bit higher when you factor in G&A, but you're in the right ballpark.
spk03: Great. Thank you very much. Take the questions.
spk02: Thank you, Jim.
spk06: This concludes the question and answer session. I would like to turn the conference back over to Rick Isworth for any closing remarks.
spk00: Thank you. Thank you all for participating on today's call and for your continued interest in support of Alamira. We look forward to sharing our ongoing progress when we report our first quarter results in late April. Thank you all very much and have a wonderful day.
spk06: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
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