Alimera Sciences, Inc.

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.

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.

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.