Alimera Sciences, Inc.

Ladies and gentlemen, thank you for standing by. Good morning and welcome to the Alimera Sciences' fourth quarter and full year 2021 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 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 May 24th, 2022. I would now like to turn the call over to Scott Gordon of CoreIR, the company's investor relations firm. Please go ahead, sir.

Thank you, Keri. Good morning, and thank you for participating in today's conference call. Joining me from Alameda's leadership team are Rick Eisberg, President and Chief Executive Officer, and Phil Jones, Chief Financial Officer. During this call management, we'll be making forward-looking statements, including statements that address Alameda'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, Form 10-Q, and Form 8-K filed by the SEC today, and Alamara's press release that accompanies this call, particularly cautionary statements in it. Today's conference call contains adjusted EBITDA, a 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. For reconciliation of this non-GAAP financial measure to net loss, its most directly comparable GAAP financial measure, please see the 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, February 24th, Except as required by law, Alan Mara 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. I'm very pleased to report that we continued our revenue growth in the second half of the year, a sign of our recovery from the pandemic. We are now positioned to return to more consistent growth in 2022 as access to positions continues to improve. We reported net revenue of $59 million in 2021, up 16% compared to the full year of 2020, driven by a strong finish to the year on our U.S. business and the OccuMention license fee that we received in the second quarter for rights to our Luvian formulation in the Western Pacific. We delivered adjusted EBITDA of $3.6 million in 2021, which compares to adjusted EBITDA of $3.5 million in 2020. Importantly, we took the initiative mid-year to increase our investments in connecting with physicians and driving growth in 2022. We believe we've seen early returns on these investments in the U.S. as end-user demand was up in the second half of 2021, with the fourth quarter being our best quarter since the onset of the pandemic. We bent the curve over the year, with U.S. end-user demand for 2021 finishing up 7% over 2020, despite being down almost 14% at the end of the first quarter of 2021. In the fourth quarter, we generated 982 units in end-user demand for a living in the U.S., up 13% year-over-year, despite the surge of the Omicron variant. And on a sequential basis, our unit volume was up 17% compared to the third quarter of 2021, indicating acceleration of our growth rate. We also had a strong fourth quarter in the U.S. from a GAAP perspective, reporting U.S. sales of $8.4 million, 14% growth compared to the fourth quarter of 2020, and 20% growth sequentially from the third quarter of 2021. Our strong performance was driven by increased face-to-face interactions, both inside and outside of the clinic, and our advocacy efforts. We're excited to have launched our U.S. Direct-to-Patients, or DTP, marketing campaign in mid-January. This campaign is designed to reach potential Alluvian patients in areas where we have high prescribing practices. We believe there is a significant opportunity to appeal to patients who desire to see better, longer, with fewer injections, and we believe the pandemic has highlighted the need for Alluvian for both patients and physicians. You may recall that we ran a successful pilot DTP campaign and selected markets in 2019. Our 2022 campaign consists of streaming video and display ads on social and other digital media, as well as a non-branded educational site. The campaign spans 10 regional markets in the U.S. that have a large prevalence of diabetes, and targets are based on behavioral and demographic qualifications. Early in the campaign, we're already trending above our weekly impression goals with our DTP tactics, and our website traffic to alluvium.com has increased more than two and a half times since the DTP launch began. We believe that this campaign will help us maintain the sales momentum in our U.S. business by reminding patients and physicians of Alluvium's benefits, namely the ability to see better, longer, with fewer injections. Turning to our international business, We note that it was challenged throughout the year due to the severe access restrictions in Europe caused by the COVID-19 variants. Fortunately, we are seeing these restrictions removed in our markets during February and March. International sales for full year 2021 were up 24% year-over-year to $32.3 million, including the $11 million upfront license fee that we received from OccuMention for a living in the Western Pacific. Excluding the OccuMention license fee, our full year 2021 international Lubion sales declined 18% from $26 million in 2020 to $21.3 million in 2021. As we previously shared, this was primarily a result of our international distributor partners building inventory in late 2020, only to see limited demand in the first half of 2021 due to the variants and restrictions. However, we did see some positive trends in our international segment in the fourth quarter, despite stay-at-home mandates and other continuing restrictions. We were pleased to see sequential revenue growth of 8% in the fourth quarter over the recently completed third quarter. And importantly, the end-user demand across our entire international segment, including both direct and indirect markets, was the highest since before the impact of COVID-19 in the first quarter of 2020. Despite the challenges of the pandemic, we continue to execute on our expansion of the global markets in which olivine is available for the treatment of both DME and noninfectious posterior uveitis. At the end of 2021, olivine was approved and available for the treatment of DME and a noninfectious posterior uveitis in 16 European countries, compared to only nine at the end of 2020. In late 2019 and over the course of 2021, We added the Nordic countries, the Benelux countries, and the Czech Republic from an availability standpoint. However, neither we nor our partners provided significant commercial support in 2021 due to the restrictions of the pandemic. We're excited for the opportunity to grow our DME business in these markets as restrictions elapse and access improves. Further, we are anticipating the opportunity for growth from the posterior UVI syndication. You may recall that earlier this month, we announced pricing approval for this indication in Spain. Our partner, Brill Pharma, is now launching into this market where treatment options are limited. Prior to this, Alevian had only been marketed for posterior uveitis in Germany and the UK. We're working on obtaining reimbursement for the additional markets and expect to launch in a few of these in 2022. Access to care appears to be improving in Europe as evidenced by lockdowns being lifted. We believe this improved access, Increased commercial activities in our new markets, reimbursement for posterior units in new markets, and normalized inventory levels with our distributor partners will lead to growth in 2022 in our international segment. And with that, I'll now turn the call over to Phil, who will review our financial results for the quarter and the full year.