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spk01: Ladies and gentlemen, thank you for standing by. Good morning and welcome to the Alamira Sciences Second Quarter 2023 Financial Results 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 two. Participants of 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 November 10, 2023. 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. Good morning, and thank you all for participating in today's conference call. Joining me from Alamair's leadership team are Rick Eisworth, President and Chief Executive Officer, and Russell Skidstead, Chief Financial Officer. During this call, management will be making forward-looking statements, including statements that address Alamair's expectations for future performance or operational results. 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 Form 10-K and Form 10-Q, as well as Alamara's press release that accompanies this call, particularly the cautionary statement in it. Today's conference call includes adjusted EBITDA and adjusted net product revenue, non-GAAP financial measures that Alamara believes can be useful in evaluating its performance. We should not consider this additional information in isolation or as a substitute for results prepared in accordance with GAAP. For reconciliation of these non-GAAP financial measures to their most directly comparable GAAP financial measures, please see the reconciliation table located in Alamira's Earnings Press release. The content of this call contains time-centered information that is accurate only as of today, August 10th, 2023, except as required by law Alimera displays 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.
spk03: Thanks, Scott, and good morning to everyone on the call. The second quarter has been full of exciting developments and strong performance for Alimera, and I'm encouraged by the foundation we are building to transform Alimera into the place to be in treating retina disease. As you probably know, we made a transformative transaction during the second quarter to acquire the commercial rights to UT from iPoint Pharmaceuticals. This brings together the only two approved long-term intervitreal therapies that help patients maintain vision longer with fewer injections by delivering continuous microdosing to reduce the recurrence of retinal disease. Importantly, this transaction has allowed us to leverage our U.S. commercial infrastructure with a second indication as we already have in our international markets, and it provides a critical mass of revenue to help ensure the long-term stability of Almera. The second half of Q2 primarily focused on incorporating UTIC into our operations and cross-training our teams to sell both Illuvian and UTIC. Our expanded team, now covering 35 territories across six regions, up from 29 territories in the first half of the year, was fully trained and in the field selling both Aleveon and ET beginning the week of July 24th. We have also expanded our thought leader liaison, medical science liaison, and reimbursement support teams in the field. I want to thank everyone at Almera for the significant effort that went into achieving this important milestone in less than 10 weeks since the closing of the transaction. Despite some distractions created by this process, the acquisition had an immediate positive impact on Almera allowing us to deliver positive adjusted EBIT on the second quarter, despite only having the product in our portfolio for six weeks during the quarter. Our global business continues to grow, as we saw record quarterly global Alluvian end-user demand of 1,601 units, up 13.5% over Q2 of 2022, including outstanding growth in our international segment, which was up 25% over the second quarter of last year. And since the acquisition, we added another 440 units of UTIC end-user demand during the quarter, bringing total demand to over 2,000 units for our flucinolone acetanide franchise. Based on numbers reported by I-Point, the UTIC end-user demand for the full quarter was 1,001 units, up 11% over the second quarter of 2022. That demand drove record quarterly revenue of $17.5 million. We are pleased with this result, but we believe revenue could have been even higher during the quarter as a result of some aspects of planning for the acquisition of UT and the incorporation of UT into our commercial infrastructure. Prior to the transaction, we had some turnover in our field team associated with the new commercial entrance in Retina, who were building their sales teams. And we maintained those vacancies longer into Q2 than we normally would in order to sort out the new territory alignment with UT on board. We also invested time out of the field for the legacy of Lubion Salesforce to learn about UT and chronic non-infectious uveitis affecting the posterior segment. Further, we had distributors reducing inventory on hand to UTIC and a shifting timing discrepancy with our international distribution partners as we combined UTIC into our supply chain. In the second half of the year, we not only expect this to correct itself, but we also believe that further incorporating UTIC in our commercial structure will yield further revenue growth and increase adjusted EBITDA for the second half of the year. Now that both products are merged together, we expect to have a broader presence with our customers at industry meetings. Recently, at the American Society of Retinal Surgeons, we showcased both products at the booth and were pleased with the feedback we received from physicians on having the product combined in our company. We were also able to hold Alameda's first UT advisory boards at that meeting. And with that, I'll now turn the call over to Russell to review our financials in more detail.
spk07: Thanks, Rick. Product revenue was up 20% to approximately $17.5 million for the second quarter of 2023, compared to about $14.6 million for Q2 2022. The increase was primarily due to the addition of UTiQ into the U.S. portfolio midway through the quarter. U.S. product revenue increased 34% to approximately $11.9 million for the second quarter of 2023, compared to U.S. product revenue of $8.9 million for the same period in 2022. This included approximately $3 million in UTIC revenue from the date of acquisition, which was May 17th. As Rick mentioned, we believe the revenue could have been higher without turnover related to the new commercial entrance and the need for our field teams to spend time training for both products. Further, as we work to transfer the distribution of UTIC to our vendors, distributors reduce the inventory on hand, purchasing 18% fewer UTIC units from us than they sold to end users. We recently completed the transition to our supply chain vendors and expect this difference to be rectified this quarter. International net product revenue remained flat at approximately $5.7 million in Q2 23, which was the same for Q2 22. As Rick said, end user demand was outstanding in our international segment. It was up 25% over the second quarter last year, but we experienced shipping timing discrepancy with our international distribution partners who sold 21% more units to end users than we were able to ship to them during the second quarter. We expect this to be corrected in the second half of this year. Total operating expenses were approximately $16.3 million for Q2 in 23 compared to approximately $14.4 million in the same period last year. The increase was primarily due to approximately $630,000 in bad debt expense and approximately $1.2 million in amortization of the new intangible asset related to the UTIC transaction. As of June 30th, 2023, Alamira had cash and cash equivalents of approximately $18.8 million, compared to $13.1 million at March 31st, 2023. On May 17, in conjunction with the closing of the UTIC transaction, we completed the second tranche of the financing from the first quarter, which added $69 million in equity, plus we raised an additional $20 million in term debt. The tranche to equity was comprised of about $2.4 million in common stock and $66.6 million in Series B preferred. On August 1st, our shareholders approved the issuance of shares of common stock upon the conversion of the Series B preferred, which triggered the mandatory conversion of the Series B into common stock and pre-funded warrants to purchase common stock. The conversion will be completed on August 15th, where the Series B preferred from both tranche one and tranche two will be converted into approximately 45 million shares of common stock and common stock equivalent for approximately 2 million shares. Rick will now give you his closing comments.
spk03: Thank you, Russell. We're well on our way towards our goal to grow Almeria into a company uniquely focused on retina specialists and their patients. The addition of UT-TAR portfolio makes us one of very few companies to have multiple commercial products focused in the retina space. It also significantly transforms our financial outlook and stability. For the remainder of the year, we expect to continue looking at ways to bring Utique and Aluminum together in our commercial and medical activities and further leverage our infrastructure to drive improved financial performance, positioning Almera for a strong 2024. As we said following the transaction, we expect to generate more than $100 million in revenue and $20 million of EBITDA in 2024. Before I turn the call over to the operator questions, I also want to highlight that we completed enrollment in our landmark New Day study. Remember, this is a head-to-head comparison of Alluvian and the leading anti-VEGF in naive or near-naive patients suffering from diabetic macular edema, or DME. From this trial, we expect paradigm-shifting data in early 2025 that will facilitate much earlier usage of Alluvian in the treatment of DME to help patients see better longer with fewer injections. And with that, I will turn the call over to the operator for questions. Thank you.
spk01: Ladies and gentlemen, if you wish to ask a question on today's call, you will need to press star, then the number one on your telephone keypad. If your question has been addressed and you wish to withdraw your question, you may do so by pressing the pound key. If you're using a speakerphone, please pick up your handset before entering your request and speaking on the call. One moment, please, for the first question. Our first question comes from Alex Nowak with Craig Halem. Please go ahead.
spk04: Okay, great. Good morning, everyone, and congrats on getting the acquisition obviously closed but also integrated here throughout this quarter. You know, as you now are integrated with the sales team, how has the initial traction been with the single unified sales team going out and selling both Alluvian and UTIG maybe in the last even couple weeks here?
spk03: Yeah, so, Alex, I think, I mean, we're obviously only about three weeks into having the teams out there on a combined basis, but I would say early feedback is good. You know, I talked to quite a few physicians at ASRS last week, and all are, frankly, similar to what we hear from investors and others. Oh, it's about time these two products are together. And I think it provides a great opportunity to talk to a physician that is already using Alluvian about using UTIC, you know, for UVA indications. and vice versa, right? It's an easy door opener for somebody that may not have been using one of the products to say, look, you're already using a long-term low-dose steroid in this indication. Why not think about it in, you know, an expanded utilization? And so it provides a great opportunity for the reps. I think the reps are pretty excited about it, and what I'm hearing from the field is good already. And we're seeing a little bit of an uptick in utilization, but it's a little bit too early to conclude on what that means for the whole quarter.
spk04: That's great to hear. And, you know, to exclude UTIG from the sales in Q2, it did look like the low band was a little bit more flat than maybe I would have thought. Just anything in particular going on there, or maybe this is just disruption with the sales force with some of the territories sitting out there longer than expected?
spk03: Yeah, I think, I mean, we did have some territories open because we held some of those positions open, you know, thinking that there would be some people to bring over from iPoint, experiencing those territories. And we did that. And we did that. And, you know, it obviously took us a little bit longer to get the transaction closed. So we had some positions open, as I said. You know, I do think there was a small impact in May as, you know, Appellus made a big effort to push the launch of syphobry out there and get the attention. And doctors were trying to figure out how to integrate syphobry into their practices. And because explaining a lube into your patient just takes a little bit longer. They strayed away from some of those conversations. So we might have seen a little bit of that in May, but I think more of it is related to just, you know, slightly less presence on the street over the course of the second quarter, both because of some of the open positions, but then we did take people out of the field, you know, whether it was for training at home or even brought them into, you know, Atlanta for training on the product. So it reduced some of the availability in the field a little bit.
spk04: Okay, understood. And then expenses going into Q3 here, you know, if I look at your OPEX, you probably did around $15 million or so for Q2. What's the sort of the step up to Q3? And then the following question to that is then is Q3 kind of a run rate on expenses from there or any additional expenses that go into Q4? Sure.
spk07: If I'm, this is Russell, if I'm understanding the question, to help understand their expenses going forward, I mean, the nice part about this transaction is that we're able to fit UT into our existing infrastructure. So there's not a, really, a very large amount of additional expenses that we're adding. But the incremental expenses we do have, I think are primarily related to the commercial side of things. And I think, yes, what you'll see in Q3 is probably, I wouldn't expect it to go much above what we were looking at in terms of cash expenses. So, yeah, I think if you make those math adjustments, I think you're probably in the ballpark.
spk04: Okay, perfect. And then his last question is just the next steps on new day. What's the expected timeline for readout now that he has the last patient enrolled?
spk03: Yeah, so the last patient was enrolled in early June, so we would expect, you know, last patient, last visit in December of 2024, and then, you know, some early readouts in the first quarter of 2025. Excellent.
spk04: All right, well, congrats on all the progress here. Thanks for the update.
spk03: Thanks, Alex. We appreciate it.
spk01: Our next question comes from James Malloy with Alliance Global Partners. Please go ahead.
spk06: Hey, good morning. Thank you for everyone sticking with the questions. On the UT, you guys, I apologize if I missed it earlier in the call. I had some trouble logging in. Did you break out what of the U.S. sales, the 11.85 U.S. sales? What was UT? What was Illuvian?
spk03: Yeah, it was roughly about $3 million of that was a pickup from UT.
spk06: Okay, great. Thank you. And then I was just mentioned earlier, the sort of the turnover related to the acquisition of the reps. How many reps do you guys have currently? Can you expand on that a little bit? Maybe I misunderstood what that meant. Were the reps leaving or can you walk me through that, please?
spk03: Yeah, so, well, Jim, as of today, we have, we expanded from, we had 29 territories historically at Ellen Mare supporting alluvian. We've expanded to 35 territories. So now we have 35 territories across six regions supporting both products. And all 35 of those reps are cross-trained on both products as of, and out in the field as of July 24th. The turnover that we referenced was, as you know, There was one geographic attribute product approved earlier this year, one just recently approved, you know, last week. And those two companies have been building their commercial teams. We lost a few reps to those entrants into the market in the first half of the year. And, you know, I made the decision to sort of leave those open because we were, you know, looking at some of the team, you know, from iPoint that have been supporting UT, we wanted to bring that expertise on board. And so we left those roles open until the close of the transaction. Excellent.
spk06: Congrats, too, on getting the EBITDA positive and income from ops. Take out a couple of the non-cash things. A positive in the quarter, long been a goal. I saw, too, that the COGS came down pretty good, at least in the quarter. Is that related in any way to UT? Because that's just fluctuations that kind of happen quarter to quarter.
spk07: I was going to say it's due to just natural fluctuation quarter to quarter.
spk03: Yeah, I was going to say, Jim, you get fluctuation quarter to quarter based on the extent that goes to the distributor partners. You know, so where we sell to our partners in France or Italy or Spain, since we have a lesser share of the revenue, the COGS is, you know, it's higher in those quarters. And as we said, we had some shipments that were, you know, deferred into the second half of the year to those partners. Okay, great. Understood. Thank you.
spk06: And maybe the last question, on a big picture, bringing the debt up by about $20 million or so from the first quarter and tripling it from last year, what's the thinking on bringing in debt versus equity? I know we're certainly perhaps lower cost of capital at risk here. No one goes bankrupt from too much liquidity.
spk03: Yeah, so, I mean, as we've said, you know, we're very excited about the leverage that this transaction creates for us. You know, we've given guidance, you know, in the last two calls that we are pretty comfortable, we're very comfortable with, you know, more than $100 million in revenue next year and $20 million in EBITDA. So $20 million in EBITDA, you know, generates a substantial amount of cash for us. And as that continues to grow, you know, we think we'll be in a position to service that debt as it starts to amortize.
spk06: All right, excellent. Well, thank you very much for taking the questions. Congrats on a good quarter. Absolutely. Yep.
spk01: As a reminder, if you have a question, please press star, then want to be joined in the queue. Our next question comes from Yi Chen with HC Wainwright. Please go ahead.
spk02: Thank you for taking my questions. My first question is, going forward, do you think UTIC will serve as the main driver for top-line growth, or do you think Illuvium could provide pretty solid growth as well?
spk03: That's a great question. You know, we are – our goal is to drive top-line revenue and utilization of the franchise, you know, of the low-dose, please send a letter to set-night assets. I do think there are some aspects about UTIC that make it easier to adopt, and if that is the way into certain accounts, we will certainly leverage that. I think we're going to look at the mix of our promotional activities, you know, in 2024 across both brands and indications based on what we see over the next, you know, couple of months as we're planning for 2024. So I certainly think that's a possibility that we try to leverage that and are able to grow it faster than Alluvium, but we need to learn a little bit more, get a little more experience in the field first.
spk02: Got it, got it. And do you think the fact that you now market Utique in the U.S. will have a positive impact on your international sales of Alluvium for profit indications?
spk03: You know, probably a little bit too early to tell on that as well, although I'll tell you there are some, some learnings and some strategies about the way iPoint had been taking Utique to market in the U.S. that we can certainly learn from, right, and try to adopt in Europe as well, and we intend to do that. I think, you know, one of the big advantages of bringing the products together is there are some things that were working really well with Alluvian, some things that were working really well with Utique, and on the flip side, maybe some things that weren't working so well with both brands, and we can try to create best practices across both, which we will try to do across our, you know, global markets.
spk02: Okay. And last question, do you believe that adjusted EBITDA will be positive for the second half of the year?
spk03: Yes, I do. Yes, I do.
spk02: Okay. Thank you.
spk03: And I think you'll continue to see improvements in the EBITDA line. Obviously, we frankly were very pleased to see positive EBITDA in the second quarter because we had planned a lot of the work around the integration of the two products together and, you know, bringing them into the same sales force. And so we're pleased to, you know, see what $900,000 of adjusted EBITDA. Now I think you'll see, you know, significant improvements to that in third and fourth quarter. Plus we only had you take for us the quarter. That's right.
spk02: Thank you.
spk01: All right.
spk03: Well, I want to thank everybody for. Go ahead. I'm sorry.
spk01: Sorry, I was just saying this concludes our question and answer session, and I'm just turning the call back over to you, Rick.
spk03: Thank you very much. I want to thank everyone for participating in today's call and your interest in support of Almera. We do look forward to sharing significant progress on bringing these two assets together when we report our third quarter results in November. Thank you very much, and have a great day.
spk01: The conference has now concluded. Thank you for attending today's presentation. You may all now disconnect.
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