Alimera Sciences, Inc.

Ladies and gentlemen, thank you for standing by. Good morning and welcome to the Lamb Air Sciences third quarter 2022 financial results in corporate update conference call. This time all participants are in listen-only mode. If 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 PCAD. To call your question, please press star then two. 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 January 26, 2024. I'd like to turn the call over to Scott Gordon of CoreIR, the company investor relations firm. Please go ahead, sir.

Good morning. Thank you, Nick, and thank you all for participating in today's conference call. Joining me from Alamira's leadership team are Rick Eiswer, 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 expectation 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-K and Form 10-Q, the Form 8-K filed with the FCC today, and Alamira'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 Alamara's earnings press release. The content of this call contains time-sensitive information that is accurate only as of today, October 26, 2023. 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 Eisworth. Rick, please go ahead.

Thank you, Scott, and good morning to everyone on the call. I'm excited to share our third quarter results, which demonstrate the leverage created by adding UT to our portfolio earlier this year. We achieved record net revenue in the quarter of $23.4 million, up 72% over the third quarter of last year. driven by the sales growth of our two brands, Illuvian and Utique. And importantly, we achieved positive $5.4 million in adjusted EBITDA in the third quarter. In the U.S. segment, we saw third quarter net revenue increase 103% to approximately $18.1 million year over year. Utique contributed $8.9 million to the quarter and continues to demonstrate significant growth with end-user demand reaching 1,045 units. an increase of 20% over Q3 of 2022. Illuvium returned to growth with end user demand of 1,146 units for the quarter, an increase of 8% year over year. We believe there is a significant opportunity to grow sales of both Illuvium and UT moving forward in the US behind our expanded sales force detailing both products and our other additional field personnel. As we shared in August, our larger team which represents over an 80% increase in reps detailing Utique and over a 20% increase in reps detailing Alluvium, began promoting both products in late July. We're still in a learning curve for our team, all who have taken on a new product. Continued training for both products is very important to our success. We held a launch meeting in July with all field employees and follow-up training in September. And we plan to continue to provide more medical and sales education in the field to further their knowledge and to increase their value to our customers. I think we will continue to get better across both indications. And this is important because we believe there is a significant opportunity to cross-sell the second product to many physicians that use only one of the two products today. For example, in the third quarter, only 27% of the accounts ordering either Utique or Alluvian in the third quarter ordered both Utique and Alluvion. This creates a significant opportunity for us moving forward. Turn to our international segment. We reported 5.3 million in net revenue during the third quarter, an increase of approximately 13% year-over-year, driven by a return to growth in Germany and continued strong performance in our other direct markets. In our direct European markets, we saw significant end-user demand growth of 20.4%, over Q3 of 2022. However, end user demand in our international segment was down 2% for the quarter, caused by the rationing of stock by our distributor partners during the quarter. As you may have seen, we were pleased to have Jason Werner, who has an extensive background in ophthalmics and significant experience in previous roles in commercial development and corporate strategy, join us as Chief Operating Officer early last month. We're already increasing our investment in this area, and Jason is working with our distributor partners and our manufacturers to improve inventory levels. We do expect to have stocking levels at the distributor partners addressed early in Q1 next year with improvement over the course of Q4. As we continue to pursue the increased utilization of Alluvian and UT, we expect that the sharing and discussion of additional data with physicians will be a significant driver. We continue to believe that the Paladin data set including improvement in visual outcomes, reduced treatment burden, and control of retinal thickness variability is an excellent marker for our new day study outcomes. As a reminder, the Paladin study demonstrated that patients with diabetic macular eczema who received a single dose of alluvium demonstrated statistically significant improvements in best corrected visual acuity, central subfield thickness, and treatment burden at 36 months, as well as demonstrating that the side effects risk of interocular pressure can be effectively mitigated when Alevian is used in accordance with its FDA label. This month alone, at the recent Uretina meeting in Amsterdam, we had four presentations of this data. And in New York at the Retina Society, we had an additional four presentations. Next month, at the American Academy of Ophthalmology in San Francisco, another presentation and three posters will highlight the efficacy and safety of Alevian from this study. From a clinical standpoint, we have several ongoing trials designed to further demonstrate the effectiveness of Alluvian and UT. Our over-enrolled New Day study, evaluating Alluvian's utility as baseline therapy head-to-head versus the leading anti-VEGF in the treatment of diabetic macular edema, has completed enrollment 306 patients and remains on track with top-line data anticipated in the first quarter of 2025. We are actively enrolling patients in our synchronicity study, which is a prospective open-label clinical study evaluating the safety and efficacy of UTIC for the treatment of macular edema associated with chronic noninfectious uveitis affecting the posterior segment of the eye and related interocular inflammation. This is a two-year follow-up study with an interim top-line six-month efficacy readout anticipated in the third quarter of 2024. Additionally, we've completed enrollment in the UTIC CALM study with 240 eyes. The CALM study is a registry study conducted in collaboration with the Cleveland Clinic, collecting real-world data to better understand the variety of conditions treated with UT for noninfectious uveitis affecting the posterior segment of the eye. We expect efficacy outcomes on individual and combined patient cohorts to be presented at medical conferences in 2024. Also with Alluvion, we are working with the DRCR Retina Network to support protocol AL Protocol AL is a randomized clinical trial evaluating either intravitreal furosemab injections or alluvian intravitreal implants versus observation and the prevention of visual acuity loss due to radiation retinopathy following plaque brachiotherapy. Looking to the future, we are actively evaluating indication expansion opportunities to broaden the number of patients that either alluvian or UT as long-acting stereo implants can help treat. We look forward to sharing further details in the coming months. And with that update, I'll turn the call over to Russell to review our third quarter financial results in greater detail.