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spk01: Ladies and gentlemen, thank you for standing by. Good morning and welcome to the Alamira Sciences 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 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 August 18th, 2023. I would now like to turn the call over to Scott Gordon of Core IOR, the company's investor relations firm. Please go ahead, sir.
spk06: Good morning, and thank you for participating in today's conference call. Joining me from Alamira's leadership team are Rick Eisworth, 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 expectations for future performance, operating and financial results, and the impact of recent transactions. 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 Alan Mayer's most recently filed periodic reports on Form 10-K, Form 10-Q, the Form 8-K filed with the SEC, and Alan Mayer's press release that accompanies this call, particularly the cautionary statements in it. Today's conference call includes discussion of forecasted adjusted EBITDA and non-GAAP financial measure that Alamara believes can be useful in evaluating its performance. You should not consider this additional information in isolation or as a substitute for results prepared in accordance with GAAP. Please refer to Alamara's press release for more information regarding Alamara's use of this non-GAAP measure. This call also discusses certain historical financial information and operating results related to iPoint Pharmaceuticals. This information has been derived from iPoint's SEC filing. The content of this call contains time-sensitive information that is accurate only as of today, May 18th, 2023. 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 Isworth. Rick, please go ahead.
spk03: Thank you, Scott, and good morning to everyone. I'd like to thank you all for your patience the last few days with the delay of our call. but given the nature of this pending news, we felt it was best to postpone. This morning, we're announcing a transformative acquisition for Almera. We are very excited to have acquired additional commercial rights for UTiQ from iPoint Pharmaceuticals, and specifically the ability to add UTiQ to our US portfolio. As you're aware, we've been looking for a retina asset to leverage the infrastructure we've built to support Alluvium for some time now. We always thought that it was important to find the right first acquisition and we believe we've found a great asset in UTiQ. The concept of combining Alluvion and UTiQ under one company and one commercial team has been a topic of discussion amongst investors, our customers, and our employees for several years, given their belief that bringing these two brands together makes such strategic sense. For those of you who don't know, UTiQ is a 0.18 microgram lisinolena-setanide intravitreal insert, much like our product Alluvion. and it is approved in the United States for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. Our current product, Alluvion, is based on the same underlying technology license from one of iPoint's predecessor entities. iPoint has grown UTEC into a significant brand in the retina space, having generated over $28 million in revenue in 2022. This growth has been driven by strong messaging centered around the ability of a consistent, but a consistent low dose of corticosteroid to control the recurrence of uveitic inflammation, resulting in a continuous calm for patients. This asset acquisition makes strong business sense for us for so many reasons. We are already very familiar with this asset, not only due to its similarities to alluvium, but also because of our experience commercializing alluvium for UVI syndication in our European markets since 2019. Both products contain the same anti-inflammatory corticosteroid, flucinolone acetinide, and both use the same technology to deliver continuous microdose of the drug for up to 36 months. Historically, the messaging behind UTiG's value has been very consistent with our Alluvian messaging. While we have promoted Alluvian as providing continuous microdosing to reduce the recurrence of diabetic macular edema, or DME, UTiQ has been positioned to deliver the same release for continuous calm in patients suffering from uveitis. Both the mechanism and the promise is the same for both products. Further, both products share practically the same customer base in the U.S., and there is significant overlap with the retina specialist that we are already calling on daily to detail alluvium. We will need to add uveitis specialists to our target list, which we estimate is between 300 and 500 new physicians. We're very excited to have several members of the UTIC commercial team join Almera to support this expanded market. As we integrate the individuals who have been supporting UTIC into Almera, we expect to increase the number of clinical account specialists, known as CAS, in their territories to 35 to 40 in the second half of the year. This planned integration and expansion means that there will be at least a 75% increase in the number of CAS detailing UTIC to retina specialists every day and at least a 20% increase in the number of CAS detailing alluvium. We believe this will serve both brands well, as the reach and frequency of engagement with physicians has been shown to impact utilization, and an increased number of reps promoting both products will allow us to see more doctors more often. Additionally, a second product should make each of these engagements more effective, as our CAS will have more reasons to have a discussion with the retina specialist. In the past, We have been disadvantaged relative to our competitors because their products are on the market with multiple indications leading to greater familiarity by the retina specialist. We expect that the ability to discuss the benefits of the only truly long-term low-dose steroids across multiple indications will strengthen physicians' relationships with Alimera and the recall for utilizing continuous micro-ing technology to treat DME and uveitis and deliver that continuous call. And most importantly, This transaction will have a profound impact on the future finances of Almera. We believe this transaction will be immediately accretive to revenue and could contribute positive adjusted EBITDA in the second half of 2023. As we reported on Monday, in a typically seasonally low quarter for both products, we recognized $13.5 million in a leave in revenue in Q1 2023, while iPoint recently reported $7.4 million in UTIC sales for the quarter. On a combined basis, Elluvian and Utique generated $20.9 million in revenue in the first quarter. Because of the product similarities and the significant overlap in our customer targets, we believe that there will be synergies commercializing these products together. We expect to begin seeing those synergies in the second half of 2023 and continue to see more in 2024 as we further integrate Utique into Alamera. And as a result, we are expecting consolidated net revenues in excess of $100 million and positive adjusted EBITDA of over $20 million in 2024. With that, I will now turn the call over to Russell to review our financial results for the first quarter and the financial details of the transaction.
spk07: Thanks, Rick. First few comments about the first quarter. During the first quarter of 2023, our product revenue increased 14% to approximately $13.5 million. U.S. product revenue increased 10% year-over-year to $7.6 million for the first quarter. U.S. end-user demand, which represents units purchased by physicians and pharmacies from our distributors, increased 9% in the first quarter of 23 to 1,005 units. And this compared to 918 units in the first quarter of 2022. from our international segment in the first quarter of 23, increased 18% to $5.9 million, as compared to a year earlier. The increase is primarily due to a 32% increase in units included in GAAP revenue in Q1 of 2023. Now, in late March, we announced a series of transactions to improve our capital structure, which we referred to as Tranche 1. We believe these important first steps laid a foundation for Alamira's future success. Not only did we add $12 million in new equity capital, but we also refinanced our term loan with SLR capital, which lowered our cost of capital and extended the maturity of the facility. This allowed us to focus our cash on more strategic initiatives like the one we announced today. We believe that the repurchase of our Series A preferred stock returns real value to our common shareholders by eliminating the overhang of its $24 million liquidation preference. Now, regarding today's announced transaction, under the terms of our agreement with iPoint, we made an upfront payment of $75 million and will pay an additional $7.5 million in equal quarterly installments of $1.87 million each quarter in 2024. I-Point will also receive potential royalties from 2025 through 2028 based on combined U.S. net revenues from Alluvian and UTiQ in certain, I'm sorry, in excess of certain thresholds beginning at $70 million in 2025 and then increasing annually thereafter. So how did we pay for it? We funded the upfront payment and obtained additional working capital with a $69 million private placement of Series B preferred stock and common stock to a syndicate of investors led by Valen Capital and Callaghan Partners, and borrowing an additional $20 million through an amendment to our existing term loan agreement with SLR Capital. The new Series B did not include any new warrants. the Tranche 1 investors agreed to reduce the number of Tranche 1 warrants from about 5.7 million to 1.6 million. We intend at our annual shareholder meeting to have our shareholders vote to approve the issuance of common stock upon the conversion of the Series B preferred. Once approved and all the Series B preferred converts to common stock, Alamira will have made great progress in simplifying its capital structure, which we believe is a great step in attracting broad interest from investors. So what did we get? We're getting an excellent product, as Rick mentioned, that has a strong year-over-year sales growth. We expect to add about $30 million in revenue from Utique in 2023, well, annually on a go-forward basis. We know the product, we know the indication, since we've been selling it outside of the US for quite a while. Not only do we expect significant growth in our top line, but because we have an existing commercial infrastructure and administrative infrastructure, we also expect a significant amount of this incremental revenue to drop to our bottom line in very short order. As mentioned, with this transformational transaction, we're expecting our consolidated net revenue to be in excess of $100 million and our positive adjusted EBITDA to be $20 million in 2024. On March 31st, 2023, we had cash and cash equivalents of $13.1 million. As mentioned earlier, in connection with the transaction, we funded the upfront $70 million payment, $75 million payment to iPoint with $89 million in new capital from the proceeds of the $69 million private placement and from our borrowing of an additional $20 million under our existing term line. I will now turn the call back over to Rick for his closing remarks.
spk06: Rick?
spk03: Thank you, Russell. As I said earlier, I'm very excited to complete this transaction. Our goal has been to grow Alamir into a company uniquely focused on retina specialists and their patients. The addition of Utique to our portfolio makes us one of very few companies to have multiple products focused in the retina space. It also significantly transforms our financial outlook and stability, positioning us to continue to look for additional products for our customer base and to leverage our commercial platform moving forward. Before I turn the call over to the operator for questions, I also want to highlight that we are nearing completion of enrollment in our landmark New Day study. As of this morning, we needed only three more patients to be randomized to achieve our initial goal of 300 patients enrolled in this study. Remember, this is a head-to-head comparison of Aleveon and the leading anti-VEGF in naive or near-naive patients suffering from DME. From this trial, we expect paradigm-shifting data in early 2025. that will facilitate much earlier usage of alluvium in the treatment of DME to help patients see better longer with fewer injections. I now look forward to taking your questions. Operator?
spk01: We will now begin the question and answer session. To ask a question on today's call, you will need to press star, then the number one on your telephone. If your question has been answered and you wish to withdraw your request, you may do so by pressing star, then the number two. If you are using a speaker phone, please pick up your handset before entering your request and speaking on the call. One moment, please, for the first question. And our first question comes from Alex Nowak of Craig Hallam Capital Group. Please go ahead.
spk08: Okay, great. Good morning, everyone. Congrats on the acquisition here, Rick and Russell. You've known the iPoint team for a very long time now. Just why did it make sense now to bring on the UTIC product here?
spk03: Well, Alex, I think, I mean, first of all, iPoint has done a fantastic job growing this into, you know, a material brand in the U.S. As I said, did almost $30 million in revenue last year. And we think, you know, they'll do over $30 million. The product will do over $30 million this year. Um, you know, we, it's something we've discussed with iPoint quite often all the time, and it just, um, it just seemed like the right time for team for both companies, you know, to do it. I think, um, you know, they see an opportunity here to see their product, um, you know, moved into a commercial team that, you know, has a little bit further reach by, you know, adding it to, you know, now a team that will have 35, excuse me, 35 to 40 reps with it, um, get some more reach and they will share some profitability on the backend. So, um, just makes sense to put the products together at this point.
spk08: No, it makes total sense. I just want to be clear, when we start to put the models together, the expense structure for LMR here going forward, so we should expect about a 20% sales force increase. Any additional expenses needed on the G&A line, any back office that will be needed to combine the two products?
spk03: Yeah, you certainly are going to see more expenses to support the product because for the time being, we will continue to operate these as as two brands. So you are going to have additional marketing dollars. You'll have additional support around market access and things like that. So, you know, we will, we're not prepared to give specific guidance on, on spending around it today because we need to do the work to integrate the product in, but you know, we'll be able to get more insight into what the spending levels will look like. And we've talked to you after the second quarter.
spk08: And that kind of leads into my next question, which is, it's always been interesting. You've always had two, two companies selling a very similar drug, Two different indications, but two different brand names and two different bags, really, from two different reps. So, I mean, how should we think about an acceleration in adoption of both of these products now that you can combine the brands at some point, you combine the products under one bag, the rep is in there more frequently? What could happen to adoption of these two products here, you know, over the coming years? And then what are you assuming in that $100 million revenue guidance for that?
spk03: So, Alex, there's a lot in that question there. Look, I think that, I think there's multiple reasons combining these in one bag, you know, can accelerate the growth of both products, right? One of the things that I referenced in my prepared comments was, you know, our competitors or other comparable drugs in this space, like an Ostradex, you know, or an ILEA, they're approved for multiple indications, right? So every time The rep from Alimera or other person from Alimera is talking to the physician. They're talking about retinal vein occlusion. They're talking about DME. They're talking about uveitis. So they're talking about wet AMD, depending on which one of the drugs they're promoting. It adds to a more lengthy call and discussion with the doctor. And then frankly, as the doctor is able to pick up the drug and use it for multiple indications, it helps with the familiarity as a patient comes in, right? Then they see that that patient needs something new. So I do think there's going to be a halo effect of, you know, whether a doctor is using Utique on Alluvian or a doctor that's using Alluvian, you know, on Utique and, you know, vice versa, and just add more of an in-depth conversation. And obviously the relationships get stronger with the doctor, the more you can talk about as well. So I think there's a lot that goes into that that we'll be able to leverage over time. You know, as far as the 100 million goes, you know, we have given guidance before that, you know, we feel like, you know, 10% to low teens growth for a living makes sense. And, you know, I point or excuse me, UT has actually been growing a little faster rate than that. You know, we're not prepared to give us because it's a big breakout on the 100 million, but we're pretty comfortable in that number for 2024.
spk08: Okay, that makes sense. And then just last question, just when does the deal close? Is it closing as of today? And then the royalty rate from 2025 to 2028, if you can provide some info there.
spk03: Yeah, so the transaction actually closed as of yesterday morning. So the transaction has been completed or closed during the day yesterday. With respect to the royalty rate, it's going to be in the double digits, low to mid-double digits. We're not going to discuss a specific rate for competitive reasons as we look for other products. The royalty could be, it'll probably be in the single-digit millions. Frankly, it's based on success. So iPoint participates in the success of putting the product into you know, the bigger sales force in the commercial team. And, you know, if it's a big number, it's only because we're very successful.
spk08: All right. That's great. Well, appreciate the update. Congrats again. Thank you.
spk03: Thanks, Alex.
spk01: The next question comes from Jim Malloy of Alliance Global Partners. Please go ahead.
spk05: Hey, guys. Good morning. Thank you very much for taking my question. And congratulations on getting the transaction done. I had a question on the royalty rate. Why is the combination of Elluvian and UTIC that you'll be paying out? And looking at sort of my estimates and consensus estimates, how do you guys do in the $60 million 2024 Elluvian already, which would indicate adding mid-$30 million of UTIC in 2024, which seems like a slowdown in growth. We're going from $17 million in 2021 to $28 million in 2022. That's a pretty good growth rate. Is the $30 million expectation of a 20-forge being conservative? What are your thoughts on what may be happening in the market?
spk03: Yes, so Jim, a couple comments on the structure of the transaction. As Alex alluded to, there's various options that we would have in the future to potentially consolidate the brands, consolidate the labels. Um, you know, we're, we haven't made any decisions on what we want to do there strategically. We're going to look at a lot of options over the next couple of years, but, you know, certainly both us and I point, we're aware of the possibilities there, um, that things could be blended under one brand. And, you know, frankly, you know, we think the brands together work better. And so that's why I point is going to receive some participation in both brands going forward. Um, you know, with respect to the a hundred million, um, You know, again, I'm not going to give a specific guidance to a number other than to say that we said over 100 million. You know, we certainly would rather be in a position where we can under-promise and over-deliver as we move forward.
spk07: I think if I can add one thing to it, too, is, Jim, the royalty is based on combined U.S. sales, not global sales. So the $60 million you referred to includes a significant amount of ex-U.S. sales. So those would not be included in that trigger level or the royalties.
spk05: Wait one quick follow-up, if I could, please. Of the $28.3 million that are reported in 2022 of UTIC sales, how much of that is in the various excluded countries?
spk02: Very, very little of it. Very, very little of it. The vast majority of that was in the U.S.
spk04: Thank you for taking my questions. My first question is, how much increase in operating expenses, especially sales and marketing expenses, shall we expect going forward?
spk03: Russell, do you want to address that?
spk07: Yeah, we will be, so the answer is we are expecting some incremental increase, certainly not a one-for-one increase if you think about what iPoint is spending on that because we will have a lot of synergies that we're going to be able to provide. We're not, as Rick mentioned earlier, we're not getting guidance on the total incremental increase partially because we need to complete the transition to find out how the steady state works. I would say most of the incremental costs that we're looking at is going to be in commercial as opposed to any of the, let's call it back office, administrative additional costs that we have. And as I mentioned in my prepared comments, I think there will be incremental costs, but we do expect because of these synergies that a good deal of the incremental revenue that we bring in is going to be able to drop to the bottom line for us, which is why this is such a transformational transaction for us. I don't know if that helped you, but we'll be able to give more guidance as we complete the transition.
spk04: I mean, is the target number of physicians or ophthalmologists you talk to increase significantly now that you market both allobionate?
spk03: Yeah, I think so. I mean, there certainly are specific physicians that treat uveitis that are going to be in our target base going forward. As I said in my comments, we expect to add maybe three to 500 physicians to our targets from, you know, looking at iPoints target lists already. And the way we're going to handle that is by increasing the sales force to, you know, between 35 to 40 reps. As far as the marketing and the messaging, you know, we think the marketing and messaging is very, very consistent between the both products. As I said, you know, we talk about the how it works, you know, with the continuous microdosing to reduce the recurrence of the disease. You know, historically, UT has been talked about with, you know, what it does deliver, which is that continuous calm. And we think it just makes perfect sense that continuous microdosing delivers continuous calm. So there'll be a lot of ways we can merge that messaging together.
spk04: Got it. Last question is, previously both iPoint and Anamara talked about a six-month version of Illuvium. Do you think there's still a market demand for that, and is that still a development project on the table for you?
spk03: We certainly have the rights to be able to do that as we move forward as a result of this transaction. So those rights have been combined across both indications as well. It's not something that is on our, you know, development list right now, but, you know, now that we are in a situation where we expect to be generating, you know, material cash flow in years to come, you know, we will certainly be looking at additional options for the technology.
spk04: Okay. Thank you.
spk01: This concludes our question and answer session. I would like to turn the conference back over to Rick Eyesworth for any closing remarks.
spk03: Great. Thank you. Thanks, everyone, for participating on today's call and your interest in Alamira. Obviously, we're very excited about this transaction, and we're looking forward to sharing more details on it as we progress and report our second quarter results later on in the summer. Thank you all very much, and have a great day.
spk01: The conference is now concluded. Thank you for attending today's presentation, and you may now disconnect.
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