Aiera/aiera-transcript-sentiment huggingface dataset:
In the same way, what's attractive to enterprises when they think about coding companions like Q, is just if you can get 30%, 40% better productivity for your developers, which in many cases, for companies is their most scarce resource, it's a game changer. And they won't roll out every bit of code that comes from a coding companion. But if it can assist them to get 80% plus the way there quickly, that's a big deal. And one of the things that's unique about Q is it's not just a coding companion, yes, it's an expert on AWS. It will help you -- it helps you write the code, but it also helps you debug the code and it helps you test the code, helps you do transformations and it helps you figure out how a multistep implement features. There's a lot of -- helps you troubleshoot. If there's something in your application that's you write, you can find it and help you fix it.
Sentiment: positive
And so -- and then it also lets you look at all your data repositories, whether it's Internet or Wickes or the 40-plus data connectors like Salesforce, Alassian, and Zendesk and Slack. And let you have an intelligent conversation to get answers and take action. So it's a pretty differentiated capability there. And when enterprises are looking at how they might best make their developers more productive, they're looking at what's the array of capabilities in these different coding companion options they have. And so we're spending a lot of time -- our enterprises are quite excited about it. It created a meaningful Reinvent. And what you see typically is that these companies experiment with different options they have and they make decisions for their employee base, and we're seeing very good momentum there.
Sentiment: positive
The question about how we're thinking about Gen AI in our consumer businesses. We're building dozens of generative AI applications across the company. It's every business that we have has multiple generative AI applications that we are building. And they're all in different stages, many of which have launched and others of which are in development. So if you just look at our -- some of our consumer businesses, on the retail side, we built a generative AI application that allowed customers to look at summary of customer review, so that they didn't have to read hundreds and sometimes thousands of reviews to get a sense for what people like or dislike about a product.
Sentiment: neutral
We launched a generative AI application that allows customers to quickly be able to predict what kind of fit they'd have for different apparel items. We built a generative AI application that in our fulfillment centers, that forecasts how much inventory we need in each particular fulfillment center. And so the start of the rollout of Rufus today is really just another step, but we think one that's pretty meaningful in being a generative AI powered shopping assistant and it's trained on our very expansive product catalog as well as our community Q&A and customer reviews and the broader web.
Sentiment: neutral
But it lets customers discover items in a very different way than they have been able to on e-commerce websites. So if you want buying advice, like what should I look for in a pair of headphones or if you are doing purpose buying, like what should I buy for cold weather golf or comparisons, what's difference in lip-gloss or lip oil or you want recommendations of the best Valentine's Day gifts or you're on a detailed page with bridge product info, where you don't want to go through the whole page, you want to ask is this pickleball rack that's good for beginners. All those questions you can pull in and get really good answers. And then it's seamlessly integrated in the Amazon experience that customers are used to and love to be able to take action.
Sentiment: positive
So I think that that's just the next iteration. I think it's going to meaningfully change what discovery looks like for our shopping experience and for our customers. And I could kind of step through every one of those consumer businesses. Our advertising business is building capabilities where people can submit a picture and ad copy is written and the other way around. And you kind of think about Alexa, where we're building a very large -- expansive large language model is going to make Alexa even more productive and helpful for customer. Every one of our consumer businesses has a significant number of generative AI applications that they either have built and delivered or they're in the process of building. And I don't see that changing for many years. We have a lot of ideas.
Sentiment: neutral
Thanks for joining us today on the call and for your questions. A replay will be available on our Investor Relations website for at least 3 months. We appreciate your interest in Amazon, and we look forward to talking with you again next quarter.
Sentiment: neutral
And ladies and gentlemen, that does conclude today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
Sentiment: neutral
Greetings, and welcome to the Eyenovia Fourth Quarter and Full Year 2023 Earnings Call. [Operator Instructions]. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Eric Ribner of Investor Relations. Thank you. You may begin.
Sentiment: neutral
Good afternoon, and welcome to Eyenovia's Fourth Quarter and Full Year 2023 Earnings Conference Call and Audio Webcast. With me today are Eyenovia's Chief Executive Officer, Michael Rowe, Chief Financial Officer, John Gandolfo; and Chief Operating Officer, Bren Kern. This afternoon, we issued a press release announcing financial results for the 3 and 12 months ended December 31, 2023. We encourage everyone to read today's press release as well as Eyenovia's quarterly report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC. The company's press release and annual report are also available on our website at www.inovia.com. In addition, this conference call is being webcast to the company's website and will be archived there for future reference.
Sentiment: neutral
Please note that on today's call, we will be discussing products, product concepts and candidates, some of which have yet to receive FDA approval. Please also note that certain information discussed on the call today is covered under the safe harbor provisions of the Private Securities Litigation Reform Act. We caution listeners that during the call, Eyenovia's management will be making forward-looking statements. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are subject to a number of risks, which are described in more detail in our annual report on Form 10-K.
Sentiment: neutral
This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, March 18, 2024. Eyenovia undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as may be required by applicable securities law.
Sentiment: neutral
With that said, I'd like to turn the call over to Michael Rowe, Eyenovia's Chief Executive Officer. Michael, the floor is yours.
Sentiment: neutral
Thanks, Eric. And welcome, everyone, to our fourth quarter and full year 2020 financial Results Conference Call. Last quarter, I talked about how [indiscernible] to pull on as we continue our growth into a development and commercial organization. Those levers were revenues, agreements and sources of capital. Today, I will share with you how we have been executing against these 3 levers particularly in terms of our advancing commercial strategy, which continues to accelerate with 2 approved products and 2 in Phase III. I will also share news about us entering into 2 significant agreements that will complement our own sales efforts as well as provide an update on our plans for dry eye. Bren will then take us through the build-out of our manufacturing capabilities, which are now fully integrated and producing commercial supply of MydCombi. And finally, John will provide an update on the third lever, our financials and the options we are exploring towards ultimately reaching a breakeven point for the company.
Sentiment: neutral
So let's dive right into it with our 2 FDA-approved products sobetosole propionate ophthalmic suspension 0.05% and MydCombi. As you may recall, the U.S. commercial rights for Clobetasol were acquired from Taiwan based for most of pharmaceuticals last August. Just last week, we transferred the NDA for clobetasol from Formosa over to Eyenovia. Pobetazole was approved just 2 weeks ago on March 4. This unique postocular surgery steroid is the first product developed using Formosa's proprietary APMT nanoparticle formulation platform. That technology reduces an active pharmaceutical ingredients particle size with high uniformity and purity, thereby allowing penetration to relevant compartments in the eye and ultimately enhancing bioavailability.
Sentiment: neutral
Clobetasol is a potent steroid indicated for pain and inflammation following ocular surgery. This is the first time that this molecule is available in ophthalmology. Its efficacy and safety profile is highly desirable with nearly 9 out of 10 patients achieving complete absence of postsurgical pain and 6 out of 10 achieving total absence of inflammation within 15 days post ocular surgery. Clobetasol has an advantageous dosing profile of twice a day without titration versus existing treatments, which require dosing up to 4 times a day. This is particularly important as eye surgery patients are often on multiple drugs during recovery. So any advancement which simplifies the treatment regimen would be welcomed by eye doctors and patients alike. And in terms of safety, side effects we're seeing in no more than 2% of patients. And our label mentions that some of these side effects could have been the result of the surgical procedure itself. You can find additional information and full prescribing information at clobetasolbid.com.
Sentiment: positive
It is estimated there are more than 7 million ocular surgeries in the U.S. each year. most of which are treated with topical ocular steroids and steroid combinations currently totaling $1.3 billion in sales. This is a very significant market opportunity and 1 that we think we can capture a mid-single-digit market share over the next 3 to 4 years. We view clobetasol as a key addition to our commercial product portfolio, which will allow us to further leverage our existing sales force. Together with MydCombi, our mydriasis product, we believe that we can bring significant value to eye care offices and surgical centers, and we are working toward a robust commercial launch of Clobetasol as soon as our partner has received their Taiwanese export license later this year.
Sentiment: positive
Longer term, we see a potential opportunity to develop a formulation of clobetasol for our Optojet dispenser as a potential treatment for dry eye, a market estimated to be worth over $3.6 billion. To that end, we plan to engage with the FDA in the coming months to discuss a path forward in that indication. While mobetazole is a great product for us, it is only half of our revenue story. MydCombi is the other half. As you know, MydCombi is the first and only FDA-approved fixed combination of 2 pupil dilation drugs, tropicamide and phenylephrine and the first ophthalmic spray using the Optejet platform. When our sales force talks with customers, they highlight how our products can help book ahead the surgery by using MydCombi as their Mitriata-agent presurgery and clobetasol as their steroid post surgery. We have now hired, trained and deployed half of our 10-person field sales force with the remainder set to come on board in the coming weeks. Also, we continue to make excellent progress satisfying state commercial licensing requirements where required, with MydCombi now licensed for sale in 16 states representing more than half of the U.S. targeted population. We have a dozen other license applications in process.
Sentiment: positive
In terms of manufacturing, in November, we were very pleased to announce that our contract manufacturer, Coastline International was approved by the FDA for MydCombi commercial manufacturing. We also recently announced FDA approval of our Redwood City facility as a commercial manufacturing facility. With Redwood City, Reno and coastline now all online, we have commenced the manufacture of commercial supply of MydCombi and we now have finished product moving into and out of our warehouse. Bren will provide a more detailed manufacturing update in a moment.
Sentiment: positive
Customer feedback on MydCombi has been excellent. And to further illustrate that point, we are very pleased to announce that Vision Source, a leading network of approximately 3,000 locally owned optometry offices has added MydCombi as an approved product for its membership. We have great expectations for the sales channel as MydCombi has particular benefits for those offices that are patient-focused and choose to incorporate MydCombi to enhance the comprehensive eye exam experience of their patients. As we like to say, these offices and doctors use MydCombi because they care for their patients. The current U.S. market for pupil dilation is valued at approximately $250 million and we feel we are well poised to take a good portion of that market share over the coming years, especially when we move to our next-generation device.
Sentiment: positive
Staying on the topic of MydCombi for a moment, we recently completed the study to determine if there was a lower dose that could be effective to achieve pupil dilation for drug-sensitive patients. The study was conducted by [ Dr. Denis Pencil  ]of the State University of New York School of Optometry. 29 subjects were treated with a half dose of MydCombi which is 8 microliters per eye. In that study at 30 minutes post-dose, clinically relevant pupil dilation was [ achieved ] in approximately 2/3 of patients and that percentage increased by 60 minutes. Almost all patients returned to a pupil size of less than 5 millimeters between 3.5 hours and 6 hours post installation. This is similar to the time seen in published studies of patients exposed to tropicamide eye drops and a mydriasis reversal drug. The dose was well tolerated with minimal adverse events reported with 3 subjects reporting mild installation site pain and 1 with mild dry eye upon installation.
Sentiment: positive
Given that a standard of care mydriasis agent, senolefrin, may present safety risks in a few older patients the greater dosing flexibility enabled by MydCombi and the Optejet could address an unmet need among the approximately 100 million comprehensive and diabetic eye exams and over 4 million cataract surgeries performed in the U.S. each year. We plan to publish the full results in a peer-reviewed journal later this year. As previously mentioned, we will soon have 10 sales representatives and 2 sales directors in the field to commercialize MydCombi and clobetasol. Half of this team is already trained and in place, working every day to present the benefits of our products and pull the revenue lever. Additionally, we recently announced a co-promotion agreement with NovaBay, a leading developer of anti-infective eye products. Per the terms of that agreement, NovaBay will promote vobetazole to hundreds of eye care professionals that our salespeople are not calling on through its telephone-based sales real. They will also conduct outreach to eye doctors in those geographic areas that our salespeople are not currently covering. Meanwhile, our field sales force will promote their prescription Avanova antimicrobial live and lash solution to our doctors who can include this product in their suite of pre and postsurgical offerings. In addition to the benefit of additional promotion and potential sales for both sides, each party will also get a percentage of the sales that they generate. This is an extremely cost-effective way to boost our commercial sales reach we believe this agreement will be very beneficial to both parties.
Sentiment: positive
In summary, we are actively promoting MydCombi and we'll be leveraging our new agreement with Vision Source. We are preparing to commercialize Clobetasol and will [indiscernible] our new agreement with NovaBay, and we are reloading our pipeline by bringing MicroPine back through reacquiring the commercial and development rights this past January for the U.S. and Canada from Bausch & Lomb. MicroPine is an investigational microliter ophthalmic spray avatropine delivered by the Optejet. MicroPine is being evaluated as a potential treatment for pediatric progressive myopia or worsening near sightness which is characterized by elongation of the sclera and retina. We estimate that more than 25 million children in the U.S. suffer from myopia, and of these 5 million are believed to be at high risk for progressive myopia. If left untreated, progressive myopia can ultimately lead to significant vision loss and potential blindness. Prior studies have demonstrated that atropine can slow myopia progression by as much as 60%, and there is a significant unmet need for safe and effective FDA-approved pharmaceutical treatment options.
Sentiment: positive
In terms of next steps, we are continuing to advance Phase III CHAPERONE study, and we plan to meet with the FDA to explore options to expedite development and registration of MicroPine in a capital-efficient manner. [ One action ] we are working on is a planned interim look at the CHAPERONE data later this year. If that interim analysis is successful, we could potentially be looking at a substantially derisked program that could be very attractive either for us alone, or for a commercialization partner. Lastly, we are maintaining MicroLine or Apersure in our portfolio should [indiscernible] market shows signs of improvement. Right now, our opinion is that we can make better use of our capital elsewhere in our portfolio, but we can turn very quickly back to this product candidate if the situation should change. So this gives us line of sight to 3 and possibly 4 commercial revenue-generating products. We continue to explore development of novel therapeutics levering the Optejet for dry eye, glaucoma and other large market indications as part of our second lever towards success. These potential partnerships are moving forward, and we anticipate sharing more information when they reach the stage of a full development agreement after all of the device compatibility work has been completed.
Sentiment: neutral
At this point, I'd like to turn the call over to our Chief Operating Officer, Bren Kern, for our manufacturing update. Bren?
Sentiment: neutral
Thank you, Michael. During the fourth quarter and through early this year, we continue to execute on our strategy to maintain control of our manufacturing processes, ensuring our products meet high levels of reliability and stability. As a reminder, we use contract manufacturers to supplies with drug substance, which we then used to fill our cartridges at our Redwood City facility. These cartridges are then married with our electronic base units which are manufactured at our Reno Nevada facility. We are now fully capable of supporting our current anticipated MydCombi commercial demand as well as the needs for ongoing micropoint development in 2024. More specifically, last month, we were very pleased to receive FDA approval of our Redwood City facility with no significant concerns raised on the part of the agency. This approval will provide Redwood City with the ability to perform final assembly, packaging and labeling activities in support of MydCombi and complements our Reno facilities and contract manufacturers.
Sentiment: positive
As previously announced, Coast Lining International also received FDA approval and is now producing MydCombi commercial supply. Redwood City will also be the manufacturing site of our Gen 2 device which has significantly fewer parts than our existing device, making its manufacturing easier and more reliable. We are targeting MydCombi as the first product that will be available in Gen 2 and our Redwood City facility is actually making a product to begin engineering stability studies and registration batches before the end of the year. Our strategy for moving from the Gen 1 to the Gen 2 will be the subject of an FDA meeting this summer, and assuming we come to an agreement, demonstrating comparability between the 2 devices should provide a path for Eyenovia to introduce the Gen 2 platform into the commercial market. Our Reno facility is also producing the Optejet injector in base in support of MydCombi and continue to expand production capabilities by refining our state-of-the-art equipment. When complete, the capabilities of this new facility will provide significant increase in injector manufacturing capacity enabling fulfillment of both our commercial and clinical product needs.
Sentiment: positive
As noted earlier this year, Eyenovia has reacquired the rights to MicroPine. MicroPine is an investigational 8-microliter ophthalmic spray of atropine delivered by Eyenovia's proprietary Optejet device being evaluated as a potential treatment for pediatric progressive myopia characterized by elongation of the retina. We are actively uplifting our MicroPine clinical management capabilities in this regard which we expect to be complete in mid April of this year. With MicroPine our management, Inovio will be speaking with the FDA to discuss opportunities to accelerate the completion of the study. I continue to be excited about our recent successes and the progress we are making. We now have 2 FDA-approved manufacturing sites that we manage, preparing us to meet the market demands for our products. I'm looking forward to expanding on these significant achievements to be made in this year.
Sentiment: positive
I would now like to turn the call over to our Chief Financial Officer, John Gandolfo, to provide a financial update. John?
Sentiment: neutral
Thank you, Bren. For the fourth quarter of 2023, we reported net loss of approximately $8 million or $0.18 per share and approximately 45.4 million weighted average shares outstanding. This includes a $0.02 loss related to the onetime repatriation costs for bringing MicroPine back to Eyenovia from Bash. This compares to a net loss of $6.1 million or $0.17 per share and approximately 35.9 million weighted average shares outstanding for the fourth quarter of 2022.
Sentiment: negative
For the full year 2023, we reported a net loss of approximately $27.3 million or $0.66 per share and approximately 41 million weighted average shares outstanding. This compares to a $28 million or $0.83 per share and approximately 33.6 million weighted average shares outstanding for the full year 2022. Research and development expenses totaled approximately $4.1 million for the fourth quarter of 2023, and this compares to $2.2 million for the fourth quarter of 2022, an increase of 84.6%. For the full year 2023 research and development expenses decreased approximately 3% to $13 million, and this compares to $13.4 million for the full year 2021. The full year decrease was driven primarily by lower direct clinical and nonclinical expenses, as well as deferral of costs related to the future delivery of clinical supply to our license partners.
Sentiment: negative