Alimera Sciences, Inc. (ALIM) on Q4 2023 Results - Earnings Call Transcript
Operator: Ladies and gentlemen, thank you for standing by. Good morning and welcome to the Alimera 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. [Operator Instructions]. After today's presentation, there will be an opportunity to ask questions. [Operator Instructions] 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 CORE IR, the company's Investor Relations firm. Please go ahead sir.
Scott Gordon : Thank you, Scott. Good morning and thank you for participating in today's conference call. Joining me from Alimera's leadership team are Rick Eiswirth, President and Chief Executive Officer; and Elliot Maltz, Chief Financial Officer; and Todd Wood will be joining us President, U.S. Operations in the question-and-answer session today. During this call management will be making forward-looking statements, including statements that address Alimera's expectations for future performance or operational results, future financial position, outlook and guidance and time line 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 Alimera's most recently filed periodic reports on Form 10-Q, or Form 8-K filed with the SEC today, and Form 10-K to be filed with the SEC from year ended December 31, 2023 as well as Alimera'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 Alimera'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, Alimera 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 Eiswert. Rick, please go ahead.
Rick Eiswirth : Thank you, Scott, and good morning to everyone on the call. 2023 was a pivotal year for Alimera. We exited 2023 much stronger than we came into it. In 2023, we accomplished many goals. We completed a strategic and transformative transactions to obtain the commercial rights YUTIQ 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 ILUVIEN and YUTIQ in future years. As we head into 2024, we see the benefits of these transactions to be completed in 2023. We acquired YUTIQ to consolidate the rights to the fluocinolone acetonide intravitreal implant technology in the U.S. and expand the indications available for us to serve patients with retina conditions. Now that we have both the ILUVIEN and YUTIQ 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 ILUVIEN and YUTIQ accounts utilize both products. With our expanded sales force selling ILUVIEN and YUTIQ in the US 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 broad array of patients is tremendous. We spent the back half of the year incorporating YUTIQ into our US business, training our commercial team to sell both products and promote both indications. We made significant progress with utilization of our products in the second half of 2023 up 9% over the second half of 2022 on a pro-forma basis. The acquisition of YUTIQ and the continued growth of ILUVIEN 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 $80.8 million. Importantly, as we projected, we are driving positive adjusted EBITDA in cash flow from operations now that we have critical mass for the 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 US 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 US revenue for the full year of 2023 to $56.7 million. US 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 YUTIQ 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 US operations. Todd brings a 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 ILUVIEN, has both indications under one brand is a great leading indicator of what is possible in the US. 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 Werner 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 uveitis indication in those markets as we introduced some of the positioning we have adopted following the acquisition of YUTIQ in the US. When Jason joined us, I was pleased to name Dr. Philip Ashman who has been with us for 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 segment both in our direct markets of Germany and 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 the chronic diabetic macular edema or DME patients with a natural lens also known as Phakic patients have access to ILUVIEN. NICE reimbursement to date has been limited to only Phakic patients defined as those who had undergone cataract surgery, which is less than one-third of the population. Now we have the potential to reach Phakic patients through 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 look 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 YUTIQ 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 have 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 ILUVIEN and YUTIQ 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 a completed enrollment in two Phase IV 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 ILUVIEN utility as early baseline therapy in naive or near naive patients in 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 if successful could change the treatment paradigm for DME by moving a long-acting steroid implant earlier in the patient journey. The last patient last visit in the 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 YUTIQ for the treatment of macular edema associated with chronic noninfectious uveitis affecting the posterior segment of the eye and related interocular inflammation. This study's purpose is to gain broader insight in the use YUTIQ boutique by the general retina specialist in real-world clinical practice as opposed to those who practice solely uveitis 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 Elliot to review our fourth quarter and fiscal year financial results in greater detail.
Elliot Maltz: Thanks, Rick, and hello, everyone. I'm very pleased to have joined Alimera at such an exciting time and 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, US 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 US for our fluocinolone implant 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 are 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 driven was primarily attributable to one, the acquisition of YUTIQ in the United States in May; and two, strong growth throughout the year in our International segment. US net revenue increased 66% to $56.7 million in 2023 compared to $34.2 million in 2022 due to the acquisition of YUTIQ in May, as well as the continued growth of ILUVIEN. 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 sell ILUVIEN directly, specifically the UK, Portugal and Ireland as well as Spain and France where ILUVIEN 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 $0.5 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 YUTIQ 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 YUTIQ. 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 in 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 ILUVIEN and YUTIQ, 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.
Rick Eiswirth: Thank you, Elliot. As I mentioned, 2023 was a pivotal year for Alimera with the acquisition of YUTIQ, 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 US and in Europe. However, there is a significant opportunity to grow the utilization of ILUVIEN and YUTIQ 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 ILUVIEN and YUTIQ 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 ILUVIEN and YUTIQ in one bag will help grow both brands as we were able to cross-sell the benefits of long-term, low-dose deliveries 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 ILUVIEN are a good indicator that the new day study will report a successful outcome and support the use of ILUVIEN earlier in the treatment paradigm for DME. We believe the synchronicity study will highlight increased utility of YUTIQ 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 will now turn the call over to the operator for questions.
Operator: [Operator Instructions] The first question today comes from Alex Nowak with Craig-Hallum Capital. Please go ahead.
Alex Nowak: Okay, great. Good morning everyone and very transformational 2023. The crossed -- so I think last quarter, you cited at 27% right now it's around less than 30%. What could that realistically go here over the next several years? And then maybe to -- question out there for Todd, just how can you think about utilization within the existing retinal specialists? How much can macro as well?
Rick Eiswirth: So I guess, I would comment first. First of all Alex, thanks for the comments. First of all, I'm going to say that with respect to the cross-sell. You're never going to get 100% overlap there because you do have a population of specialists that treat only Uveitis. But certainly, I think we internally aspire to get that number up over 50% in the next 12 months if we can do that to drive revenue. Todd, I don't know if you want to comment on the other questions?
Todd Wood: Yes. Yes, Rick. Hi Alex, how are you. Thanks for the question. Yes, 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 with YUTIQ and get retina specialists looking at postsurgical inflammation as it is Uveitis and there's a crossover there. So it's going to be a little bit of work to do in that. But I agree with Rick that the 50% seems like a good number to get to. We won't get all of it, but there's opportunity for crossover.
Alex Nowak: And in the past, we've talked about there was trialing of new drugs in the DME and then likely the Uveitis market as well. Just what's the latest on, I guess more or less the competitive environment out there for both DME and Uveitis?
Rick Eiswirth: Yes. I think in DME, you are seeing some of the competitive aspects of a new entrant into the space in the second half of the year, last year competing with another strong rival. And you are seeing 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 consistent with what we've seen in the past, when our new anti-VEGF comes along, although there's trial, in the end, there still seems to be that block of patients that comes through and needs really a corticosteroid to treat the broader inflammation in the odd that the anti-VEGF can address. So although we lose patients for a period of time maybe the trial of a strong anti-VEGF, those patients ultimately work their way through to us.
Alex Nowak: Yes, absolutely. And when can we expect top line data for the NEW DAY study?
Rick Eiswirth: It'll be sometime in early 2025. The last patient, last visit in the fourth quarter, so probably toward the end of the first quarter, early second quarter in 2025.
Alex Nowak: 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 return indications? What are your thoughts there?
Rick Eiswirth: Yes. Look, I think as we talked about on last call and said today we are continuing to look at places where we can do some indication expansion. I think corticosteroids have 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. 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 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.
Alex Nowak: Okay, got it. And then just lastly, kind of clarification around the interest expense. It looks like it came in pretty high here for Q4, which is the normal interest rate expense to assume for 2024 with the addition of the $5 million now on top of it?
Rick Eiswirth: Elliot?
Elliot Maltz: I can take that question. So, we would expect a typical run rate, to be around ballpark, let's call it, $3.5 million on a quarterly basis, but this was adjusted in Q4 because we met the -- 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 six to nine months of the year and then interest expense will again begin to normalize.
Alex Nowak: Okay, got it. I appreciate the update. Thank you.
Rick Eiswirth: Thank you, Alex.
Operator: Next question comes from the line of James Molloy with Alliance Global Partners. Please go ahead.
James Molloy: Hey, good morning guys. Thank you very for taking my question. And I was wondering if you could walk through sort of the -- what message is sort of -- has resonated best with the doctors in the fourth quarter going forward? And how does that sort of change over the year if at all? And can you walk through how many reps currently have working and other retention even through the year?
Rick Eiswirth: Yes. So, Todd, may want to comment on this as well. I think where the big opportunity for us, especially now that we can talk about two indications within [indiscernible] diseases, uveitis and for DME. A lot of the patients that are easy for us to go after those that are already on Ozurdex, right? Because Ozurdex or Allergan has been promoting against uveitis and DME for a while as well. And so there's just a border group of patients there that we can go after and assist. So, I think those conversations are 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 Synchronicity data. We have about -- we have 35 territories across the country right now. We've had sort of we call the normal attrition. We have some of the people that we have decided to turnover in the sales force. We have not had too many people need to go to competitors or anything like that this year because I think we've got a pretty strong culture here but 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?
Todd Wood: Yes. Yes. I'll add to that Rick. And as Rick said, OZURDEX is the target. There's opportunity to displace that competitively. And when we look at messaging the – and we look at our advocates of use. They view 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.
James Molloy: All right. Great. Thank you. Then maybe a quick housekeeping. Maybe you touched on in the prepared comments already. What was the G&A – the jump in G&A in the fourth quarter?
Rick Eiswirth: So a few items – one-off events during the fourth quarter. There was about $1 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's another $0.5 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 balance when you look at things quarter-over-quarter.
James Molloy: Okay. It's about $2 million or so of one-timers in the quarter?
Rick Eiswirth: Approximately, a little bit higher when you factor in G&A, but you're in the right ballpark.
James Molloy: Great. Thank you very much for taking the questions.
Rick Eiswirth: Thanks, Jim.
Operator: This concludes the question-and-answer session. I would like to turn the conference back over to Rick Eiswirth for any closing remarks.
Rick Eiswirth: Thank you. Thank you all for participating on today's call and for your continued interest and support for Alimera. 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.
Operator: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.
