Sentiment Analysis of the earnings transcript to help figure out if there are any bullish or bearish sentiments that could be gathered from it. We're doing ML and AI based analysis on the earnings call to get some more insights.
Please consider a small donation if you think this website provides you with relevant information
| Statement |
|---|
| We are pleased to share with you the tremendous progress we've made over the past three months to build on our previous successes and provide clarity on our plans going forward |
| We are also making excellent progress with another one of our late-stage pipeline programs or OTX-TIC, our travoprost intracameral implant being developed for the treatment of patients with primary open ankle glaucoma or ocular hypertension |
| We believe the commercial and Medicare Advantage payer landscape provides another growth opportunity for DEXTENZA |
| Surgeons, ASC, and staff confidence and DEXTENZA's efficacy and safety profile has resulted in significant growth over the last four quarters, and we expect that to continue in Q4 and beyond |
| So, up through that nine month timeframe, we're very confident that we'll do at least or better than that |
| We should be pleased that the FDA is encouraging direct comparison in a Superiority setting |
| This program has demonstrated the potential for best-in-class durability, and we believe truly has the potential to change the standard-of-care in this multibillion dollar market |
| Finally, as Anthony noted previously, and based on performance year-to-date and trends over the last several months, we remain confident reiterating our DEXTENZA Net Product Revenue Guidance for the full year 2023 to be between $55 million and $60 million, representing potential growth of approximately 10% to 20% over 2022 |
| And as formulators, we're very excited that we can bring this forward |
| We are pleased to report another impressive quarter for DEXTENZA with net product revenue of $15 million for the third quarter of this year, 26% over the same quarter previous year, and in line with Q2 net product revenues |
| That -- as Anthony mentioned, is very encouraging |
| I'm also very pleased to report that the sub-study to evaluate the safety of a repeat dose of OTX-TIC 26 microgram in a small subset of subjects within the current Phase 2 clinical trial is progressing well |
| But we still believe that the surgery center provides us the greatest opportunity |
| I hope it's clear that this is a very exciting time for Ocular and we're thrilled with our progress to date and look forward to sharing additional updates in the coming quarters |
| After a modest start in July, DEXTENZA sales rebounded in August and September by recording the highest consecutive two-month volume in 2023 |
| We've only captured less than 5% of all cataract volume and still believe that's the best opportunity for growth for DEXTENZA in 2024 |
| This is a program we are very excited about based on the compelling data that we have shared in the past year |
| I mean, we're very fortunate that we have cash at the moment and we have a runway into 2025 |
| Earlier this year, we launched a commercial assurance program to help with patient out of pocket costs, and that has also helped an increase surgeon utilization of DEXTENZA beyond Medicare Part B |
| With a recent interest around the iDose program at Glaucos, we are excited about the prospects of bringing a fully bioresorbable prostaglandin delivery implant that is designed to be suitable for chronic dosing into pivotal programs as our next step |
| I mean, if it's not come through, we are unbelievably excited to have the SPA behind us now, that we have a clear roadmap |
| We believe the same attributes that make AXPAXLI a compelling product in vet macular degeneration, the ease of use of an office-based injection, and long-term durability could establish this as the first standard-of-care in the treatment of diabetic retinopathy |
| For the third quarter of 2023, DEXTENZA Net Product Revenue grew to $15 million from $11.9 million over the comparable period in 2022, while collaboration revenue was approximately $0.1 million for each period |
| While we're disappointed in the final ruling, we are still confident in DEXTENZA's long-term prospects |
| Now, the great thing about having the SPA is that it's really allowed us to have a concrete response from the FDA and allowed us to have a tremendous number of conversations with sites and with the opinion leaders |
| I'm also pleased to announce a number of exciting developments for OTX-TKI, our axitinib-containing intravitreal implant for the treatment of wet AMD |
| We are extremely lucky to have deep connections in the retina community with Dr |
| While we're disappointed in the final ruling, we're still confident in DEXTENZA's long-term prospects |
| In Q3 2023, DEXTENZA recorded net product revenue sales of $15 million, approximately 26% higher than the same period last year |
| Clearly, once we get traction on this first pivotal, the desire to set up another pivotal in order to get to market in a reasonably short period of time is overwhelming, given that the destination, the value of two positive pivotals in a wet AMD with a nine to 12 month product is a multi-billion dollar opportunity |
| Statement |
|---|
| In part because of unwanted side effects, improper drop installation technique, or simply forgetting to take their daily drops, we believe most patients fail to comply and may ultimately lose their vision |
| But I mean, there were two hugely important points in this SPA that we brought in that could have made the trial either more difficult or made us rethink the trial |
| Selling and marketing expenses in the third quarter of 2023 were $9.3 million, as compared to $10.2 million for the comparable quarter of 2022, reflecting primarily a decrease in professional fees and services |
| While there are many medications available to lower intraocular pressure or IOP, Glaucoma remains a leading cause of blindness |
| The company reported net loss for the third quarter of 2023 of $0.5 million, or a loss of one cent per share on a basic basis and $0.25 per share on a diluted basis, compared to a net loss of $24.2 million or a net loss of $0.31 per share on both a basic and diluted basis per share for the comparable period in 2022 |
| Visual outcomes in a real world do not come close to matching those we see in clinical trials |
| The FDA understood the question, told us that it would be a review issue clearly for patients that are dropping out or going outside of treatment protocol for efficacy reasons |
| The second thing was realizing that this is a trial that in the ILEA arm is likely to have a relatively high number of dropouts, comparatively to other trials that may be in the space |
| Our sample size would not, is not enough for that |
| I've talked a lot about what has changed, but one thing that is definitely not changed is the unmet need for greater durability products in wet AMD, mainly due to the heavy injection burden of currently approved treatments |
| So, we certainly don't expect any difference in safety |
| While we believe the path for AXPAXLI is now clear, and our internal focus now turns from careful planning to flawless execution, there's still a tremendous amount of education done |
Please consider a small donation if you think this website provides you with relevant information