Alimera Sciences, Inc.

Ladies and gentlemen, thank you for standing by. Good morning and welcome to the Alamara Sciences third quarter 2022 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 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 February 14th, 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.

Thank you, Danielle. Good morning. And thank you all for participating in today's conference call. Joining me from Alamira's leadership team are Rick Eisworth, President and Chief Executive Officer, Bill Jones, 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, the 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 will include references to adjusted EBITDA and to adjustments in net product revenue to exclude fluctuations in foreign currency exchange rates, each of which is a non-GAAP financial measure. Please see the explanatory language and 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, November 14, 2022. Except as required by law, Alamira 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 Eiswurth. Rick, please go ahead.

Thank you, Scott, and good morning to everyone on the call. We're very pleased to deliver another strong performance for Alluvian global end-user demand, with record third-quarter demand in both our U.S. and international segments. Both were up 27% over the same period a year ago. Year-to-date, we are also posting record performances in end-user demand, up 32% in the U.S. and 16% in Europe, compared to the same nine-month period last year. Our reported revenue of $13.6 million for the third quarter grew 11% over the third quarter of 2021, but was negatively impacted by the weakening euro and British pound sterling that reduced our reported revenue by approximately $800,000. On a currency-adjusted basis, Our revenue growth was 18% compared to the prior year quarter. Year to date, through the end of the third quarter, 2022 consolidated net revenues were $40.1 million compared to $34 million for the same nine-month period in 2021, representing 18% growth. But year to date, revenues were also negatively impacted by approximately $1.9 million due to the exchange rate fluctuations. On a currency-adjusted basis, Our revenue grew 23.5% year-to-date. In the U.S. segment, we saw third-quarter revenues increase 27% to $8.9 million year-over-year. Our focus on increasing face-to-face interactions with customers across multiple formats continues to drive the strong performance, as we saw end-user demand of 1,061 units, a record third quarter for our U.S. segment, and growth of 27% over 837 units in the third quarter of last year. We are finding success with our Challenge 22 program, a performance initiative being driven by our regional sales directors. In this program, the regions are hyper-focused on certain key accounts and work to drive cross-functional collaboration and workflow within each account. This 360-degree effort has so far demonstrated significantly positive results, with accounts in this program growing at three times the rate of the broader account base. The success of this program is serving as a model for the entire organization and it's consistent with one of our key guiding principles of cross-functional collaboration. As a result, beginning in January 2023, we will broaden the scope of this program by increasing our sales regions to five without increasing the number of sales territories, allowing more time for the regional directors to focus on these initiatives while providing the coaching and leadership of their respective sales teams. Additionally, The positive Paladin study data results and follow-on data presentations and publications continue to be well-received by retina specialists. We intend to publish even more data sets from Paladin throughout next year. These compelling data are enabling our U.S. commercial team to highlight the benefits of alluvium while addressing any challenges to the usage of alluvium. As a reminder, the Paladin study demonstrated that patients with diabetic macular edema, or DME, 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 proving that the side effects of interocular pressure can be effectively mitigated when alluvion is used in accordance with our U.S. FDA label. The data also shows that patients often achieve better results when alluvion is used earlier in the treatment pathway for DME. Dr. Sam Rensour, Medical Director of the Virginia Retina Center, presented new data from the Paladin study at the American Academy of Ophthalmology conference in October. That data demonstrated that alluvium can improve eye health by reducing retinal thickness and that patients receiving an alluvium implant required 46% fewer therapies to manage their DME in the Paladin study on average. These results reinforce the efficacy benefit of alluvium, demonstrate that DME can achieve better results with significantly fewer injections, and further support the hypothesis of our New Day study. Turning to our international business, we reported $4.7 million in product revenue during the third quarter, down approximately 10% year over year. However, international segment revenues were materially impacted by the effects of the foreign exchange rate fluctuations, which reduced our reported revenue by approximately $800,000. On a currency adjusted basis, our international business was up 6% over the prior year period. Our overall international segment is strong. with end-user demand having grown 16% year-to-date over the prior year. But our international results reflect that some countries have been slower to return to growth than others. We expect almost all countries to return to growth in 2023. Our opportunity to grow living behind the non-infectious posterior uveitis indication remains a priority in our strategic growth. Over the first nine months, we obtained reimbursement in six European countries for our non-infectious uveitis indication, driving strong performance in our French and Spanish markets specifically. As a result, we saw record monthly end-user demand in our international segment in October. We expect that sales to this syndication will continue to fuel the sales growth of our international segment. Turning to corporate initiatives, in September, we agreed to study Lubin's ability to prevent visual acuity loss associated with radiation retinopathy for the DRCR retina network. The study, labeled Pareto Call AL, anticipates enrolling 600 patients across three treatment arms with primary choral melanoma that will undergo radiation treatment for their condition. Patients will receive either an alluvian implant, repeated injections of anti-VEGF therapy, or sham injections. In each arm of the study, patients will be monitored for the emergence of macular edema. The objective is to determine if alluvian or anti-VEGF therapy can prevent or significantly reduce the occurrence and recurrence of radiation retinopathy. This study is anticipated to begin in the first quarter of next year, and we look forward to participating in Protocol AL with the DRCR Retina Network to find the best solution for patients at risk for this treatment complication. Turning to our landmark clinical study, the New Day study, we continue to enroll patients with the objective to demonstrate the benefits of Levin as baseline therapy for all patients diagnosed with DMA, provide a significant reduction in the frequency of necessary injections, and lead to better long-term outcomes. This head-to-head trial against the current standard of care is now more than 70% enrolled. We have not enrolled patients for the study as fast as we would have liked, in part due to the healthcare and staffing shortages in the U.S., having caused a bit of slowdown during the summer months. We now anticipate completing enrollment in early 2023 rather than the end of this year. Assuming the primary objective of the New Day study trial is met, we believe that Alluvine will become a formidable competitor to the $7.5 billion standard of care, DME treatment, and provide a significantly greater revenue opportunity for Alamare. And with that, I'll now turn the call over to Phil to review our third quarter financial results.