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spk03: Ladies and gentlemen, thank you for standing by. Good morning and welcome to the Alamara Sciences 2022 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 July 1st, 2023. 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.
spk04: Scott Gordon, Core IR Thank you, Jason. Good morning, everyone, and thank you for participating. in today's conference call. Joining me from Alamira's leadership team are Rick Eiswer, President and Chief Executive Officer, and Russell Gibstead, Chief Financial Officer. During this call, management will be making forward-looking statements, including statements that address Alamira'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 Alamira's most recently filed periodic reports on Form 10-K and Form 10-Q, including the Form 10-K and Form 8-K filed with the SEC today, and Alamira's press release that accompanies this call, particularly the cautionary statements in it. Today's conference call includes adjusted EBITDA and adjusted net product revenue, non-GAAP financial measures that Alamira 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. 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-sensitive information that is accurate only as of today, March 31st, 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 Eisworth. Rick, please go ahead.
spk02: Thank you, Scott, and good morning to everyone on this call. I'm very pleased to share that our company experienced robust revenue growth this past year in 2022. which was largely driven by significant end-user gains in both our U.S. and international segments. As a result, we believe we are very well positioned to continue sustaining this momentum in 2023, having strengthened our balance sheet and extended our term line agreement just recently. We are excited to continue building on this success and remain committed to delivering value to our customers and shareholders. We reported net product revenue for 2022 of $54.1 million, a 13% increase over 2021, driven by record global end-user demand growth in both our U.S. and international segments, with 23% and 21% growth respectively. In fact, our global end-user demand in 2022 was 17% higher than in 2019, the last year unaffected by the COVID pandemic. So we are very pleased to have returned to pre-pandemic levels of growth. Also of note, our consolidated revenue and growth was materially impacted by the deterioration of the Euro and the British pound, which reduced revenue by approximately 2.4 million in comparison to the prior year. Our adjusted net product revenue, which reflects revenue had foreign exchange rates remain constant over the periods, grew 18% year over year. Additionally, in 2022, we continued our geographic expansion by gaining approvals for our non-infectious uveitis indication affecting with the posterior segment and five additional countries, France, Spain, Italy, Portugal, and Ireland, and gain reimbursement approval in the Czech Republic. We saw strong launches of the UVI syndication in our French and Spanish markets in 2022, and we're excited to see the impact of Alluvium being available for physicians and patients in these newly launched markets for a full year in 2023. Importantly, all of our distributors have high expectations in 2023, as we've already received firm purchase orders in excess of $8.8 million for 2023 from these partners, which is already 19% greater than our shipments to distributors in 2022. In 2022, we also achieved significant milestones for our business. We published the primary manuscript for our Paladin study in the Pure Verge Journal Ophthalmology, The American Journal of Ophthalmology also published a deeper dive into the value of olivine and reducing injection treatment burden, which, as you know, continues to be a very hot topic in retina today. And we also submitted manuscripts to three other peer-reviewed journals in 2022, one of them, an expert consensus on olivine, published this month in OSLI. This paper indicated that a group of prominent retina specialists gained consensus on topics such as chronic low-grade inflammation and its associated cytokines being key drivers of DME, that corticosteroids like alluvium have a broad inflammatory mechanism of action, that alluvium has a stable and manageable safety profile, and that alluvium is the only long-acting DME treatment that can reduce retinal thickness variability and treatment burden while significantly improving vision. We also look forward to the potential publication of two additional submissions in the coming months regarding both the manageability of the safety of olivine and the value of controlling retinal thickness variability. On the clinical side, we continue our progress in enrolling patients in the landmark New Day study, our ongoing head-to-head clinical trial designed to demonstrate the advantages of olivine as baseline therapy over repeated anti-VEGF injections in the treatment of naive and near-naive patients suffering from DMH. We enrolled an additional 137 patients in 2022, and as of today, the study is 92% enrolled. We expect to complete study recruitment during the second quarter. And we also entered into an agreement with the JAB Center for Health and Research Foundation, acting on behalf of the DRCR Retina Network to support and provide olivine for a randomized clinical trial, evaluating intravaginal furosemab injections or flucinolentacetinide intravaginal implants versus observation for the prevention of visual acuity loss due to radiation retinopathy. The study is also known as Protocol AL. When utilized as baseline therapy, as is being used in our New Day study for DME, we believe alluvium's continuous microdosing delivery will prevent, delay, and reduce the occurrence of the complication of radiation retinopathy and its consequent vision loss for patients treated with plaque brachiotherapy. We anticipate the DRCR starting this trial in the second quarter. And with that, I'll now turn the call over to Russell, who will review our financial results for the fourth quarter and full year.
spk05: Thanks, Rick. Consolidated net product revenue for 2022 was $54.1 million. This was an increase of approximately 13% from the $48 million that we reported in 2021. Our 2022 revenue was negatively impacted by currency fluctuations of $2.4 million during the year. On a constant currency basis, as Rick mentioned, adjusted net product revenue grew 18% for the year. Recall that our consolidated revenue in 2021 included $11 million in non-product revenue that we received from our license agreement with OccuMentions. That $11 million in 2021 was a one-time addition to our revenue. It should not be confused with revenue from product sales. U.S. product revenue was up 28% for the full year, from $26.7 million in 2021 to $34.2 million in 2022. This was driven primarily by the 23% increase in end-user demand. have previously shared our gap revenues in the United States do not always correlate with end-user demand due to the timing of purchases by our specialty distributors. In the fourth quarter of 22, Alamira's U.S. distributors purchased approximately 3% more units than were sold to end-users. Net product revenue from our international segment decreased 11% from $19.9 million in 2022. This compares to the $21.2 million reported in the same period last year. But keep in mind, the $2.4 million negative currency fluctuation impacted our international segment's revenue recognition. So on a constant currency basis, international revenues would have been $22.3 million or a 5% growth over 2021. For the fourth quarter of 2021, our consolidated net revenue was approximately $14.1 million, which was flat compared to the fourth quarter of the prior year, but negatively impacted by $600,000 due to the exchange rate deterioration. On a currency-adjusted basis, Q4 product revenue was up 4% over Q4 of the prior year. Our US segment revenue for the quarter was $9.4 million, which was up 12% versus a year ago. Our US growth in fourth quarter lagged what we expected and saw in the early quarters of 2023. This was due to some temporary challenges associated with the sampling of furosemab and the temporary unavailability of copay funds for all Medicare retina patients due to shortfalls in the Chronic Disease Fund in October. The temporary shortage also impacted other branded drugs in a space like Alea. Despite these challenges, however, we still had a strong quarter. Total operating expenses in 2022 were $57.8 million, an increase of 11% compared to the $52.2 million reported in the prior year. The year-over-year change was primarily due to investments that we initiated in the second half of 2021 to increase our engagement with physicians as we emerged from the pandemic. We believe these efforts were successful and contributed to the significant end-user demand growth that we saw in 2022. In Q4, we noted this in our third quarter call, We began tapering our expenses in the fourth quarter to adjust our spending on a go-forward basis to be more in line with pre-pandemic levels. As a result, our Q4 2022 operating expenses were $14 million, which was down 5% from the same quarter the prior year and down 7% from the prior quarter in 2022. For the full year 2022, we reported an adjusted EBITDA loss of $7.9 million compared to a gain of $3.6 million in 21. Keep in mind, however, that 21 included the one-time benefit of the $11 million from OccuMention. In Q4, our adjusted EBITDA loss was cut in half when compared to the third quarter. So we are making progress. On December 31, 2022, we had cash and crash equivalents of approximately $5.3 million. This compared to $5.5 million that we reported in September 30th of 22. As we decreased our cash burden, we announced on Monday that we also raised gross proceeds of $12 million in our March 2023 equity financing, and this will bolster our cash position. With that, I'll turn it back to Rick.
spk02: Thank you, Russell. As I said earlier, I'm very pleased with the significant global end-user demand we saw in 2022 and our return to growth. We believe that we strengthened the company and prepared it for future success with the transactions we completed last week. We believe that the repurchase of our Series A preferred stock returns significant real value to our common shareholders by eliminating the overhang of the $24 million liquidation preference. And as Russell said, the $12 million equity raise and extension of our debt facility allow us to continue focusing on meaningful growth and the generation of positive adjusted EBITDA and cash flow moving forward. Entering 2023, we believe we have returned to the scale at which we entered 2020 prior to the pandemic and anticipate generating positive adjusted EBITDA in 2023. And with that, I will turn the call over to the operator for questions.
spk03: Thank you. Ladies and gentlemen, if you wish to ask a question on today's call, you will need to press the star key followed by 1, then on your telephone. If your question has been answered and you wish to withdraw your request, you may do so by pressing the star, then 2. 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 from Craig Howland Capital. Please go ahead.
spk01: Okay, great. Good morning, everyone. So I want to touch on what you just left off on, which is around the recent financial kind of structure that you announced earlier this week. You know, the company we saw here in Q4, you're right around that break-even mark. So it does suggest that additional capital wasn't needed, but The new capital also includes some additional tranches that could be pulled. So I guess the point blank question is what are you going to do with the new capital?
spk02: Yeah, so I think there's a couple things. One, you know, we just want to strengthen the balance sheet in general because you always have to have cash for a rainy day, Alex, right? And some of that was done in concert with working with the lender to get the extension that we did. But we also, as I've said, want to leverage the infrastructure that we have built as we move forward. We want to look for additional products to add for the bag, and we're very pleased that both our lender in SLR and our new investors in Veland and Callaghan are supporting that effort as we move forward. Really excited to have the new board members and those new investors because I think their philosophy of building this company, making it a bigger retina company, bigger ophthalmology company is very, very consistent with mine. And, you know, they're prepared to support us in doing that. So, you know, we can't talk about specific products right now, but our intention is to go out there and find something to leverage what we've built here.
spk01: It makes sense. I'm going to push a little bit on the additional products, though, because I know the company's talked about this in the past, and now we're just in the different financial spots. So I understand why it all makes sense now. But, you know, would the plan be, whether it be preclinical, early clinical, or are these commercial products that, you'd want to add? I mean, I had to think about the range of options there.
spk02: Yeah, I mean, so obviously, Alex, it's, it's, it's quite opportunistic, right? I think there are, there's a lot of things we've looked at over the last couple of years. Some of those we've passed on, some of those we have missed. And frankly, some of those, some of those were probably lucky that we missed on. I think, you know, the primary goal would be to find something that would be accretive to the financial statement, you know, immediately. So something that we could drop in the bag and generate a lot of gross margin and really leverage the infrastructure we've built. Those would be the initial goals. And I think, frankly, if we can find something like that, that then opens up the door for, you know, earlier stage things that would require development dollars, but then we'd be developing, we'd be generating those development dollars with other products in the bag first. So, you know, it's really all of the above, but initial goals would be to find something that is an existing product or would be available very soon for the market.
spk01: Okay, that's great to hear. Maybe a couple questions around the quarter. Maybe expand a bit on the shortfalls in the Medicare funding. I think I missed that specific component in October. Maybe what was the quantitative impact that you saw there?
spk02: Yeah, so the issue is the Medicare patient, we provide copay assistance for commercial patients to help subsidize copays. You can't do that for Medicare patients. So Medicare patients generally rely on a chronic disease fund for supplementation of their co-pay assistance. Around October 1st, the chronic disease fund sent letters to the doctors saying that, you know, they were out of money and wouldn't be funding co-pay assistance, you know, for the foreseeable future, the rest of the year. And so we think that had an impact on utilization, you know, of Alluvian. During the quarter, we know that I believe during Regeneron's call, they talked about the impact on Aaliyah sales during the quarter. That funding came back toward the end of November, and they started funding co-pays during the year. So I believe our growth in end-user demand in the U.S. was between 4% and 5% over the quarter. You know, we would have expected it to be up in the teens, and, you know, we think we'll be able to see that going forward. You know, the other thing that happened that, you know, Russell mentioned in his comments is When Farisimab got its J code around October 1st as well, we believed that there was kind of heavy sampling into the market for leftover samples that was going to be paid for. And we think in connection with the lack of copay assistance that was available, there was an easy alternative that was free that doctors could use and sort of postpone the utilization of other drugs by using Farisimab at the time.
spk01: Okay. Got it. That makes sense. And, you know, regardless of, I guess, the co-pay assistance there on those trialing in the new drugs, when you've gotten, let's say, into December or let's say in the first quarter of 2023, has the trialing really subsided where you're not seeing as much of a headwind anymore or is there still prevalent out there?
spk02: I think it's, I mean, I think it's, for the most part, it's cycled out. But, you know, there was some cycling of that in the first quarter because you know, quite a, that first map specifically is, you know, one of the things about it is it's more durable, right, than some of the other anti-VEGFs.
spk01: Got it. And you put everything together. I mean, how should we be thinking about growth for 2023? I mean, you started the call off mentioning we're back to pre-pandemic growth levels. Is that the right way to think about 2023?
spk02: You know, I hope that it is, and I think that's possible, Alex. I will tell you that, you know, we think that driving positive EBITDA, right, and cash flow is a critical component of our future, as we've talked about. So, you know, internally, we sort of model for conservatively 10% growth and try to drive EBITDA around that number, and then we hope to positively surprise throughout the year.
spk01: Okay, got it. And the last question here, just around the New Day readout, timing around that, and then You got a couple of years here with OccuMention in China. What's the sales potential there or at least how to think about it?
spk02: So with respect to the New Day study, you know, we expect to complete enrollment in the second quarter, you know, I hope as early as the end of April. You know, we're getting close to the final stretches there. If we can complete the enrollment in the second quarter, we would expect to have top line data in late 2024. that we could begin talking about both commercially and medical presentations, et cetera, in early 2025. To be honest with you, it's a little bit too early to give you guidance on the OccuMention, what the OccuMention sales in China might be. But remember, we took a significant amount of money up front, a very low margin on those unit sales. And then most of the revenue that would come in from OccuMention in the future would be a milestone based if we get here. So probably a little bit too early to give projections on that.
spk01: Okay, understood. Appreciate the update. Thank you. Thank you for your support, Alex.
spk03: Our next question comes from Yi Chen from HC Wainwright. Please go ahead.
spk06: Hi, thank you for taking my question. Could you comment on whether there's a change in physicians' praxis today or at least change in their opinion of potentially using a steroid-based product as a first-line treatment? Thank you.
spk02: I'm not sure if I completely understand the question to you, but we, you know, we do continue to see a shift in, we continue to see a shift in more physicians, you know, using steroids in their practice, right? I think there is more and more discussion out there at every industry meeting about the need to address the broader role of inflammation in diabetic macular edema. And that's something that the anti-VEGFs, you know, can't do as a as more of a mono-focused drug, right? The steroids have a very broad mechanism of action addressing multiple cytokines in the pathology of the disease. And frankly, the doctors are seeing the need to get that more under control. That's evidenced by a study I've referenced quite a few times from the DRCR, where they used anti-VEGFs on a monthly basis for six months And regardless of what type of anti-VEGF it was, anywhere from 35% to 65% of the patients have persistent edema, right? And everybody believes that's because of the underlying inflammatory aspect. So I think you're seeing doctors see that data, see the positive impact, frankly, of both Ozerdex and Alluvian in treating these patients more broadly and are starting to shift to steroids earlier. It's why both Ozerdex and Alluvian are growing. You know, we also see a huge desire out there for longer-term, more durable therapy, right? It's what is talked about with the potential higher dose of ilea. It's what's discussed with the availability of furosemab. And, frankly, we think we're very lucky that, you know, we've got eluvian. We've had eluvian for a while, and it is clearly the most durable therapy by a significant measure compared to all of those alternatives, whether anti-VEGF or steroid.
spk06: Got it. In the European markets, would you say DME is the primary driver for user demand, not uveitis?
spk02: I'm sorry. You're hard to understand. I think you asked if DME or uveitis would be the primary driver. Is that correct?
spk06: Yes. I'm asking in the European markets, is DME still the primary driver in grossing user demand, not necessarily the uveitis indication, right?
spk02: You know, I would say it's both. I think we continue to drive greater usage in the DME segment as well. However, remember, our DME label in Europe is a little bit more restricted, so the expansion of the NIPU or uveitis indication is driving some of that more rapid uptake in these markets. The great thing for us is, though, having a second indication to talk about there, we think gets us more time with the DME doctors. It gets them experience in uveitis to see the value of the durable therapy that then eventually translates into more usage in DME. So we're able to leverage that rapid growth and uptake in uveitis to then generate more utilization in DME.
spk06: Got it. And lastly, would you expect the operating expenses to remain relatively stable throughout 2023?
spk02: We do. We do. We're not quite down in Q4 at the level, you know, we would expect. You'll see some additional, you know, decreases in Q1, and then they should stay stable over the course of the year.
spk06: Got it. Thank you.
spk02: Great. Thank you.
spk03: This concludes our question and answer session. I would like to turn the conference back over to Rick Isworth for any closing remarks.
spk02: I want to thank everyone for participating on today's call and your continued support and interest in Almera. We do look forward to sharing additional results as we go through the year, specifically our first quarter results, which we probably release in early May. Thank you all and have a wonderful day. Conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
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