Alimera Sciences, Inc.

Ladies and gentlemen, thank you for standing by. Good morning, and welcome to the Almera Sciences first quarter and 2024 financial results and corporate update conference call. At this time, all participants are in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your touchtone phone. To withdraw your question, please press star then two. Participants on 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 14th, 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.

Thank you, operator. 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, Elliot Maltz, Chief Financial Officer, Todd Wood, President of U.S. Operations, Philip Ashman, President of International Operations. During this call, management will be making forward-looking statements, including statements that address Alameda's expectations for future performance or operational results, future financial position, outlook and guidance and timeline for achieving positive cash flow. Forward-looking statements involve risks and other factors that may cause actual results to differ materially from those statements. For more information about these risks, please refer to the risk factors described in Alamira's most recently filed periodic reports on Form 10-Q, the Form 8-K filed with the SEC today, and the Form 10-K filed with the SEC for the year ended December 31, 2023, as well as Alamira's press release that accompanies this call, particularly the cautionary statements therein. 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 Alamara's earnings press release that accompanies this call. The contents of this call contains time-sensitive information that is accurate only as of today, May 14th, 2024. Except as required by law, Alamara 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.

Thank you, Scott, and good morning to everyone on the call. We experienced a very good first quarter, aligning with our internal expectations. As we continue to see the benefits of integrating UTiQ in our U.S. portfolio, We're also seeing excellent growth in both our international distributor markets, as well as some of our key direct markets in Europe. In Q1, our consolidated global net revenue increased 70% over Q1 2023 to $23 million, driven primarily by the acquisition of UT and growth in global end-user demand, 23% on a pro forma basis. You may note that this revenue is below that for Q4 2023, but this seasonal decline is anticipated each year as patient deductibles are reset and physicians resubmit their benefit verifications, lowering the utilization of higher-priced products like Utica and Alluvium. As we communicated last quarter, we are now generating positive adjusted EBITDA on a quarterly basis, achieving $1.8 million in Q1 2024 versus an EBITDA loss of $2.4 million in Q1 2023. We reiterate our confidence in achieving $105 million in revenue and at least 20% adjusted EBITDA margins this year. As I mentioned before, we do expect our revenue to fluctuate quarter to quarter due to the seasonality of our business. Adjusted EBITDA will also fluctuate quarter to quarter due to this seasonality as spending is more consistent on a quarter to quarter basis. In our U.S. segment, net revenue in Q1 2024 increased 92% to $14.6 million this year. versus $7.6 million in Q1 2023, primarily, again, due to the acquisition of UTiQ. U.S. end-user demand for our products was up 96% in Q1 versus the prior year, when including the addition of UTiQ, and 2% on a pro forma basis. We believe that the growth of Olivia and UTiQ in Q1 softened from integrating a combined two-product sales call. We restructured the call plan to prioritize targets across current users and how guess all targets, and enhance the level of effort against each product. We are seeing improvement as we've seen sequential growth in monthly end-user demand for our products on an aggregate basis every month since December of last year. Further, our U.S. sales team has been selling both UT and Alevin for three quarters now, and we're starting to see the value of cross-selling the two products to accounts in this quarter. as the percentage of accounts using both products has slightly increased from 26% to 28%. In order to accelerate the growth of both products, we're tightening on messaging decisions for both Alluvian and ET. For Alluvian and DME, we are reframing the value proposition, linking the severity of disease to retinal thickness variability, as this concept is catching on with retina specialists and being utilized by our competition. If the swelling in the retina is allowed to recur as acute treatments wear off, it can lead to permanent retinal damage and vision loss over time. The sooner the retina can return to a healthy level and the more consistently it can stay there, the better opportunity to improve and save vision. For UT, our sales team now has the three-year data from the UT Pivotal 001 study that illustrates the benefit of long-term control for chronic noninfectious uveitis affecting the posterior segment of the eye. It shows that the median time to the first recurrence of uveitis is over 1,000 days for the ET patient, while it's less than 100 days for the sham patient, a substantial benefit. Turning to our international business, we are pleased with our continued momentum to begin the year. In Q1 2024, international net revenue grew 42% to $8.5 million, driven by a 53% increase in user demand. We continue to see growing utilization in the U.K., Portugal, Ireland, Spain, and France. In March, the U.K. National Institute for Health and Care Excellence, or NICE, issued final guidance stating that the glucinolinacetamide intravitreal implant is recommended for treating visual impairment caused by chronic diabetic macular edema, irrespective of lens site. What this means for us is that now phagic patients, or those that have a natural lens, now have access to Elluvian. NICE reimbursement to date has been limited to only pseudophagic patients, or those that have undergone cataract surgery. This is a significant expansion of our potential user base among the chronic diabetic macular edema, or DME, patient population. According to the UK Macular Society, Fakie patients represent up to 75% of the broader DME population in the United Kingdom. We expect the availability of this wider reimbursement to positively impact utilization in the UK in the second half of 2024. NICE guidance can also impact reimbursement in other countries, such as Spain and Italy. We believe that this NICE decision, if adopted in other markets, will broaden our potential patient base in these countries as well. I would now like to highlight the continued progress and key milestones we achieved this quarter in our clinical trials. We reached the enrollment target for the Phase IV open-label synchronicity study in January that we inherited from iPoint just a few months after our acquisition of UT. This study, which we'll read out in the second half of next year, will provide retina specialists with a broader sense of the utility of our Fluciniline Asset9 implant across a variety of patients with chronic noninfectious uveitis affecting the posterior segment of the eye, also known as NIUPS. This potentially, this will potentially benefit both UT in the United States and in leaving it in Europe and the Middle East. Additionally, we have three abstracts highlighting our UT column registry study presented last week at two meetings. The Association for Research and Vision and Ophthalmology, also known as ARBO, and the Retinal World Congress. all demonstrating that real-world safety and efficacy outcomes are consistent with the pivotal clinical trial outcomes. Definitely, we were pleased to announce that the first patient has been randomized in the DRCR Retina Networks Protocol AL. The study is titled A Randomized Clinical Trial, Evaluating Intravitreal Fericinab Injections for Flucinolone Acetinide Intravitreal Implants versus Observation for the prevention of visual acuity loss due to radiation retinopathy. This study will assess the development of macular edema and associated long-term visual acuity effects of consistent and continuous release corticosteroids or repeated injections of anti-VEF initiated near the time of radiation therapy compared to observation, developing in patients at risk for radiation retinopathy. The study plans to include 600 patients with primary corridor melanoma, receiving treatment with plaque brachiotherapy. Over 40% of radiation retinopathy patients have been shown to experience the devastating vision loss associated with radiation retinopathy within three years of treatment. And currently, there are no FDA-approved pharmacotherapies for radiation retinopathy. And with that update, I'll now turn the call over to Elliot to review our first quarter financial results in greater detail.