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| Statement |
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| So, you're seeing physicians bring patients back mid-treatment, at the end of treatment, and almost universally you're hearing vast improvements in these patients, positive feedback |
| Our fourth quarter and full-year results reflect our ability to generate meaningful revenue while continuing to advance our pipeline of innovative therapeutics, and I'm proud to report that we generated fourth quarter XDEMVY net product sales of approximately $13.1 million and full-year 2023 product sales of approximately $14.7 million |
| Since its launch in late August, we have seen tremendous demand in growing uptake of XDEMVY among eyecare professionals, or ECPs, and demodex blepharitis patients who have long awaited an effective treatment for this damaging and impactful eyelid disease |
| As such, we expect gross-to-net discounts to be flat to slightly higher in the first quarter, and then improving to our expected steady state of 50% in 2025 |
| These are impressive early numbers, exceeding even our own expectations |
| Throughout the fourth quarter of 2023 and early weeks of 2024, XDEMVY has continued to solidify its place as an innovative category-creating therapeutic |
| As we progress the year, obviously we should see continued improvements both in volumes and gross-to-nets |
| With that said, we do see some exceptional cases where the doctors have had patients come in, had a great response, want to keep them on therapy |
| But again, we're really pleased with starting from a great point and the progress we've made so far |
| This traction is attributed to the tremendous strides we've made with ECPs over the last couple of years |
| And I think the other point is, we've obviously made great strides and we have better than expected gross-to-nets, but getting to that 50% threshold that Jeff mentioned earlier, that next step up is going to take a lot of work and that's going to take those contracts coming into place |
| As mentioned earlier, sales for the year were driven by the thousands of ECPs who have started their patients on XDEMVY to more than 17,400 bottles that were delivered to patients, and better-than-expected gross-to-net discounts of approximately 58% |
| Just to reiterate, first and foremost, what an excellent first quarter serving our patients, doctors, payers, as you know, and generating revenues |
| In fact, our improving gross-to-net underscores the strong traction we've already made with payers in just the first few months of launch |
| And that's really what motivates us to continue to secure contracts, and we're making great progress there |
| I'm also proud of our continued pipeline progress as we work to bring more new categories of therapeutics to patients with meibomian gland disease, rosacea, and Lyme disease prevention |
| And I think that has allowed us to maximize this opportunity |
| And clearly, you dramatically outperformed that, improving meaningfully quarter-over-quarter |
| As I said last quarter, the response to XDEMVY has been truly remarkable, and the results we're seeing so far demonstrate that our unique strategy and executional strengths are delivering exactly as planned |
| These numbers are powerful and reflect the strong potential growth opportunity ahead |
| And all of these, as you've seen, are above target and signify the large impact that we anticipate with XDEMVY, and really the category-creating commercial leadership that we're pioneering in eye care |
| As such, high impact disease education campaigns and ECP engagement have been among the key pillars to our success, and we're beginning to see the initial waves of ECP adoption, leading to growing prescription volumes and meaningful patient outcomes |
| The sales force has done a remarkable job here |
| We're thrilled with these results and the impact we're having on patients |
| Secondly, I'm really proud that we can create additional categories through our now demonstrated ability to deliver other new medicines |
| And then the data, we are really, really pleased with the data |
| On the Lyme program, we are really excited about this program |
| We're very proud of this strong first quarter and we look forward to a steady build from here |
| As you may have seen in this morning's earnings release, we announced positive topline results from the Phase 2a Galatea trial evaluating TP-04 for the treatment of papulopustular rosacea, or PPR |
| So, while having the next 6,000 target ECPs prescribed may take more time and effort on the part of our sales team, we have great confidence in our ability to convert this next wave of ECPs to proactive prescribers |
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| After the 3Q calls in November, you told us to be cautious going forward on gross-to-nets and/or volume, I guess, given some expected maybe unbudgeted pushback from payers, given the early uptake |
| I think in terms of any type of step-back on a PA, I think that's something that we see as a headwind as volume increases |
| With that said, we do anticipate that should drive incremental utilization, but some of that is also offset by some of the headwinds we mentioned earlier, right? Q1 is always a difficult quarter |
| Just building off a question that was asked previously, again, last quarter, you spoke to us about the potential payer headwinds as these non-contracted payers may start to implement more prior auths |
| The drug doesn't disappoint |
| You have a lot of issues in terms of whether when doctors aren't in the office, aren't able to diagnose and treat these patients |
| I mean, the data is pretty profound |
| This could include increasing copays or co-insurance, which could result in greater bridging and higher gross-to-net discounts |
| I think as we look at going forward, one thing we have seen is that there's a high degree of promotional sensitivity, which makes sense |
| I think we're cutting a new pathway here with XDEMVY, and we don't really have a strong analog we can point to |
| And obviously, this is a product that's dependent on getting those new diagnoses in, right? So, I think that you're seeing it sort of an offsetting effort here where the contracts are going to drive incremental volume and utilization, but we are obviously in the first quarter seeing some of those headwinds come to fruition, with doctors being out of the practice for a multitude of reasons, and then the insurance impact that we see there |
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