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| Statement |
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| That's something that's amazing and the fact that every other month dosing into GALE in nonsubfoveal patients is so meaningful |
| The year ended with SYFOVRE in a very strong position, and we remain encouraged by the continued uptake and high compliance rates for EMPAVELI in PNH |
| So, the good news is we're in a pretty strong position and we have a lot of options available to us to opportunistically make sure we have a sufficient cash balance |
| So there's still an opportunity for growth for us to target that other half of the market and we have some good plans to go and execute that which we started in the first quarter and expect to move into the -- for the rest of the year |
| Hopefully, the weather stays friendly to us, so we continue to expect to see solid numbers in March as we move forward |
| I think that's very positive as physicians start to really understand the benefit-risk profile of this drug and be able to have those conversations with patients |
| These numbers underscore the retina community's confidence in the benefits of SYFOVRE and the central role it plays in improving patients' lives |
| As we've mentioned before, we're incredibly excited about what we can do in the kidney to the readout of the VALIANT trial this summer and what we will be able to do for the 5,000 patients with C3G and IC-MPGN that are in need |
| Physicians now, I believe, truly see the benefits of our overall clinical profile |
| The good news is with the capped call, with the $125 million of essentially non-dilutive capital, in addition to the $351 million we reported at year-end, that puts us in a great financial position |
| We have strong payer coverage with our J-code from October 1st |
| So we truly believe that the every-other-month dosing, as we call it, six to eight weeks, is a real, real competitive advantage for us, and that the vast majority of patients are choosing that frequency |
| We also continue to have a very strong safety profile |
| Now, the second part of your question, the 90%, is, I think it's down to a lot of things, right? Continued strong execution from the team, particularly over the last few months, we've been incredibly transparent with the retina community, and I think we've spent a lot of time building trust and confidence |
| We also had multiple positive data readouts, including up to three years of efficacy and safety data from both of our approved therapies |
| We are entering 2024 from a position of strength with an unwavering commitment to address unmet needs for patients and to create even greater value for our shareholders |
| This strong growth underscores the rebound in weekly demand that began in August of 2023 |
| So that's an incredibly positive metric |
| As I reflect on this past year, I am extremely proud of our team and all of our achievements in 2023 |
| And with the auto injector, the EMPAVELI Injector, we're really improving that convenience aspect of the drug |
| We are encouraged by the demand growth we are seeing in the first quarter so far |
| I think that's an incredibly positive metric for us |
| But for now, I think we have a strong package with clear evidence |
| What I think is important here is that the data that we have on microperimetry is very strong, right? And its data that, again, the longer you treat patients, the more you see these benefits increase over time, and that is also reflected in the functional measurements that we have |
| Before I hand it over to Caroline, I'll close by saying that I am incredibly proud of both the SYFOVRE and EMPAVELI medical and commercial teams |
| This was a strong finish to the year |
| So, the team is flawlessly executing, I'm incredibly proud of them and we're pushing incredibly hard as you would expect us to |
| So, look, as we've always said, we believe that we have strong evidence, of course not in a pre-specified prospective trial, but based on what we gathered throughout our very large data set |
| By simplifying administration and offering greater mobility, we believe the injector elevates the patient experience and fortifies our competitive position |
| The positive trends witnessed across the key leading indicators for this patient population have continued through the end of 2023 |
| Statement |
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| As you know, we received a negative opinion by the Committee of Medicinal Products for Human Use or CHMP, for the marketing application of SYFOVRE in the EU |
| For example, I mean, we believe that earlier has not seen growth above 5% in Q1 versus Q4 over approximately the last 10 years, with several years resulting in a quarter-on-quarter decline in Q1 |
| However, as expected, we did see some seasonality in January as a result of Medicare recertifications, as well as weather delays affecting doctor visits and product shipments |
| So the vast majority of that was due to recertifications and we also had a few weather delays |
| And then, obviously, during the rare episodes of vasculitis last year, we did see that bilateral usage slow down |
| So while we don't guide, certainly there will be pressure from this world product |
| Cedric, I appreciate, as you pointed out, that it's not going to be easy for the CHMP re-examination, it's an uphill battle |
| And we reported a net loss of $89 million and $529 million respectively |
| To be clear, and as we've said many times before, this is not going to be easy |
| And finally, our operating expenses do not yet reflect the ongoing efficiencies that we expect from our restructuring last August due to severance and winding down of certain projects |
| We are facing a more competitive market with the recent approval of an oral product in PNH |
| Just to add, you know, I think the bilateral usage was definitely impacted as you said |
| So my assumption on sampling going up prior to those months turned out to be wrong |
| As we've always mentioned, this will be an uphill battle |
| Will it have an impact? That is really impossible to tell for us |
| Just maybe as a follow up on bilateral treatments, presumably there is a slowdown during the vasculitis phase |
| Interestingly, we didn't see sampling increase in the first quarter, which, I'll be honest, I thought it probably would, as we were going through the recertifications |
| It did not increase versus Q4 too dramatically |
| It will be an uphill battle, and we do not know the likelihood of success at this stage |
| As Sobi previously disclosed, the decision was made to end the study due to decreased medical need in the CAD space and a limited number of patients eligible for the study |
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