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| Statement |
|---|
| This -- we had a really strong Q4 |
| That's great execution and real progress towards our goal |
| We continue to make great progress toward our goal of a global peak revenue of $1 billion |
| So on the IRA, particularly next year when the max out-of-pocket shifts to $2,000, we think that will be an advantage for patients in terms of affordability |
| It was great to see such a strong Q4 and full-year 2023 for ORLADEYO |
| And if you have an oral alternative for a breakthrough attack, we think that's great |
| 2023 was another impressive year for ORLADEYO starting with generating $326 million in revenue in just the third year of launch |
| The other key part of it is that we have a very differentiated product in a once-daily oral and that's something that patients and healthcare providers really want |
| The strong evidence from patients also continues to shape prescriber expectations and give them confidence |
| This is an exciting time for ORLADEYO, because after three full-years on the market, we are seeing a very consistent picture emerge from the building evidence |
| Real-world experience and the long-term clinical data are telling a very consistent story and how ORLADEYO can provide meaningful benefits to a variety of HAE patients |
| This real world evidence demonstrating the long term safety and effectiveness of ORLADEYO is exciting |
| So I think the company is in a great spot |
| These patients also reported meaningful long-term improvements in quality of life, treatment satisfaction, and an overall safety profile that is very reassuring for people living with this lifelong disease |
| Achieving independence from the capital markets, while we also continue to invest in further expanding our global reach for ORLADEYO and expanding our label with the pediatric indication, while also further advancing our exciting early stage pipeline puts the company in a very strong position moving forward |
| Not just the revenue performance, but the continued underlying strength in net new patient adds, giving us confidence of achieving between $380 million and [$400 million] (ph) in global ORLADEYO revenue this year on our path to peak sales of $1 billion |
| So 0.5 attack per month is doing very well |
| to equal about $200 million of the $1 billion in sales and what we see so far gives us confidence that we'll get there |
| And it's really because they've had experience and they're seeing it work extremely well in patients |
| Our team has been hearing the stories of ORLADEYO over the past three years, and these data further illustrate why it is such a favorable treatment option for people living with HAE |
| Third, we improved the percentage of paid therapy in the commercially insured part of the business from [7%] (ph) to 79% |
| What's most meaningful to people living with HAE is that they get the chance to live a normal life by minimizing their attack burden and experience meaningful improvements in their everyday quality of life, all while avoiding the unnecessary potential burdens of treatment |
| This drug works spectacularly well in certain patients |
| And the confidence in the docs is really high |
| Additionally, with revenue exceeding $350 million, it puts us into a tier whereby the incremental revenue will be more profitable as the blended royalty rate is reduced |
| So again, this is a very notable improvement and looks very similar to injectables in terms of attack rate control |
| And again, those patients did very well, achieving an attack rate of 0.5 at day 540 |
| And so having that as a choice for patients, we think it's just another benefit |
| Of course, some patients do drop out, but this represents how well patients when they're doing well in ORLADEYO, they're doing really well and sticking on therapy |
| What is even more exciting is that the data we presented at Quad AI are just the start |
| Statement |
|---|
| The number one reason is perceived lack of efficacy |
| Jon Stonehouse To keep somebody in a study for two years is challenging certainly |
| So I think 7% or 8% drop from Q4 and probably mid-80s in revenue for Q1 |
| And so it's not uncommon to see people not succeed and you see that in some of these results |
| The number two reason is adverse events, specifically gastrointestinal, which is not surprising given the product label and our clinical trial experience |
| And while it can be convenient for some I think that fear and fatigue of injections can be underestimated |
| The main reason for the dip in Q1 is the broader percentage of patients getting reauthorizations |
| I would just add, I think people underestimate the fear of injections that patients experience |
| Ex U.S., first of all, once we -- the biggest challenge or the biggest time factor is getting market access in an ex U.S |
| It doesn't seem to be worse than that, but it's not solved |
| Are there challenges, maybe ex U.S |
| For 1Q, yes, we expect similar seasonality with the first quarter revenue being down versus Q4 |
| In some months, patients may not share what their attack rates are |
| These include about $5.4 million attributable to the R&D reorganization, including costs related to the reduction in force and the postponement of the expansion of the Discovery Center in Birmingham, Alabama |
| So the question is, it can't be efficacy, right? Because if you're controlled on our drug, then you can't do any better |
| What I'd say is it's not solved yet |
| This low and consistent rate of attacks on ORLADEYO meets patients' expectations, because they know from experience that perfect control is unlikely with any product |
| And remember, some patients don't do well in our drug |
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