7/27/2022

speaker
Maria
Conference Operator

Ladies and gentlemen, thank you for standing by. Good morning and welcome to the Alimera Science second quarter 2022 financial results and corporate updates conference call. At this time, all participants are in a listen-only mode. Should you need assistance, please sign our 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 the star then one on your telephone keypad. To withdraw your question, please press the 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 October 27th, 2022. I would now like to turn the call over to Scott Garden of Core IR, the company's investor's relation firm. Please go ahead, sir.

speaker
Scott Garden
Investor Relations Representative, Core IR

Thank you, Maria. Good morning, and thank you for participating in today's conference call. Joining me from Alameda's leadership team are Rick Eisworth, President and Chief Executive Officer, and Phil Jones, Chief Financial Officer. During this call, management will be making forward-looking statements including statements that address Alamara'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 and Form 10-Q, the form 8K filed with the SEC today, and Alamara's press release that accompanies this call, particularly the cautionary statement in it. Today's conference call includes adjusted EBITDA, a non-GAAP financial measure. For the definition of this non-GAAP financial measure and a reconciliation 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, July 27, 2022. 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 Eisner. Rick, please go ahead.

speaker
Rick Eisworth
President and Chief Executive Officer

Thanks, Scott, and good morning to everyone on the call. We are excited to share our second quarter results, having set new records for end user demand in both our U.S. and international segments. End user demand represents units purchased by physicians and pharmacies from our distributors. On a GAAP basis, we are reporting $14.6 million in global consolidated net product sales for the second quarter of 2022, a 36% increase over the same period last year. With these results, The first six months of 2022 exhibited the strongest first half sales performance in Alamira's history, which gets us back to prior business levels, and we believe back to the growth that we were generating before the pandemic. In the U.S. segment, second quarter product revenue was $8.9 million, up 53% over the second quarter of 2021. This was driven by second quarter end-user demand growth of 45%, compared to the same period in 2021. Further, end user demand was also up 16% sequentially over the first quarter of this year. These positive results were fueled by an improvement in face-to-face interactions with our customers, both inside and outside of the clinic, as access improved significantly from 2021 and from the first quarter of this year. In addition, with our recently published Paladin study results, we've had an increase in podium time at several recent conferences, which we believe will continue to drive a paradigm shift to earlier utilization of olivine in the treatment of DME. For the last couple of years, we've been working to change the view of DME and the way it is treated, highlighting the importance of treating inflammation more broadly and the value of treating disease more consistently to reduce the waxing and waning of edema, protect the retina, and provide better visual acuity results. At the recent annual meeting of the American Society of Retina Specialists, two well-known key opinion leaders, Dr. Christopher Rehman and Dr. Victor Gonzalez, presented abstracts from our recently published Paladin study. Dr. Rehman's presentation reported data on alluvian's ability to reduce retinal thickness variability, a measure of the extent of fluctuation of retinal thickness over time. Importantly, Dr. Riemann's presentation emphasized the correlation between improved disease control with Illuvian and improved visual outcomes, a key component of our positioning. Dr. Gonzalez's presentation highlighted that eyes with baseline visual acuity of 20-40 or better achieve superior visual, anatomical, and treatment burden outcomes with Illuvian, supporting our view that Illuvian should be used earlier in the treatment paradigm before significant visual loss. We believe these abstracts and data strongly support the hypothesis of our New Day study to demonstrate the benefits of the use of Illuvian as baseline therapy in newly diagnosed patients with DME. As a reminder, the New Day study is the first head-to-head comparison of corticosteroid therapy and anti-VEGF therapy, the multibillion-dollar standard of care in this type of patient. Over 45,000 eyes have been treated with Illuvian, giving a significant real-world experience and understanding of how our drug works, which contributed to the New Day study design. This experience and the results of the Paladin study and other post-marketing studies give us great confidence that we can achieve a successful outcome from this trial and drive a significant shift in utilization of Eluvian. I'm pleased to report that the study is now close to two-thirds enrolled. In the U.S., our direct-to-patient, or DTP, marketing campaign that we launched earlier in the year continues to deliver strong metrics. The campaign consists of streaming video and display ads on social and other digital media in 10 regional markets. For the first six months, we have exceeded our goals with close to 40 million impressions and over 2 million views of our video ads. We believe that our DTP campaign is effectively messaging that Alluvion allows patients to see less injections, less doctor visits, and fewer waiting rooms. and actually see more of the things they want to see. We believe that this campaign and the data from the Paladin study will help us continue the recent sales momentum in our U.S. business by reminding patients and their physicians of Aleveon's benefits, namely the ability to see better longer with fewer injections. Our international business, we're reporting $5.7 million in product revenues during the second quarter, which is up over 16% from the same period last year. As Phil will explain, the growth in our international segment was strong, but muted by the deterioration of the exchange rate, which reduced our reported international revenue by approximately 10%. Importantly, end-user demand in our international segment grew by over 21% compared to Q2 of 2021 and was up 9% sequentially over the first quarter of this year. This demonstrates recovery from the pandemic and the positive impact of renewed commercial support. Additionally, We are excited about the opportunity to drive further growth in the international markets as availability of Bolivian for the treatment of non-infectious uveitis affecting the posterior segment of the eye increases. So far this year, we have announced the receipt of pricing and reimbursement approval for this indication in Spain, Italy, and France. Our Spanish partner, Brill Pharma, launched this indication in the second quarter. Partners in France and Italy are expected to launch the uveitis indication in these territories in September after the summer holidays. We believe the UVID syndication in all of these markets will support growth over the remainder of 2022 and in 2023. Of particular note, we are excited about the launch in France, as our French distributor, Horace Pharma, launched the DME indication in 2019 and quickly made France our second largest market measured by end-user demand. I'll now turn the call over to Phil to review our financial results for the first quarter.

Disclaimer

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