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| And this has been driven by strong performances across all of our leading metrics, but I especially want to flag new patient enrollments, which have exceeded 70 over each of the past three quarters, which is stronger than we’ve seen in the past |
| We have significant positive cash flows for more than $200 million of moving annual total sales of RUCONEST that can fund Joenja launches and pipeline development to start with |
| As you can see in the first bullet, we posted strong growth in Q3 |
| So we’re really pleased with our performance |
| And we are very pleased, of course, with the results and a strong revenue growth of RUCONEST 18% up on the second quarter and 11% up on last year’s third quarter |
| In addition, we’ve seen a well-tolerated and generally safe adverse event profile |
| And as already mentioned, payer discussions have and continue to go very well, which creates, importantly, an excellent environment for us to pull those patients through once they’re diagnosed and enrolled |
| And of course, we were very pleased to get a very fast approval from the FDA back in March, brought the product to the market and got reimbursed patients almost immediately when we are on the market |
| Such that we go already record revenues in the second quarter of this year, which was the first quarter Joenja was on the market |
| And now, of course, we’re very proud of the continued growth of Joenja, where in this quarter, we booked $6.5 million of revenues and year-to-date, $10.3 million |
| team have delivered strong results in that first six months since launch |
| And last but not least, as we have a very strong commercialization infrastructure in both the U.S |
| And I think combined with the exceptional execution I’ve already mentioned, our U.S |
| So I’ve mentioned Pharming’s strong customer and patient focus |
| And really, this is based on exceptional customer focus and execution, which further instills I believe, in our confidence in our stakeholders, but most importantly, the patients and treating physicians |
| So that’s really a very strong performance |
| And that has been the remainder driver for the consistent success of RUCONEST over the nine years post-launch, and it’s why the prescriber base continues to grow with 700 in the U.S |
| So we had a dip in sales in RUCONEST, but we have very well recovered from that, and we are now on a positive note, and that is in line with the guidance that we gave earlier this year |
| So you see the space in this pipeline to further accelerate the growth of the company going forward |
| And we can see that both in key measures of what’s called lymphoproliferation so their lymph nodes continue to stay not enlarged, and we see benefits also in their immune cell function |
| And the net loss was $7.4 million, which is an improvement from Q2 this year |
| And the other thing I would say is, we have a very well tenured team, so deep relationships within our physicians’ offices and with their staff |
| And as indicated in previous calls, and I think as everybody on this call knows in relation to the environment more broadly, access, once a patient is diagnosed, is one of our key pillars for success and the ongoing success of this launch |
| Joenja was improved in the first quarter, and we’ve been commercializing in the U.S |
| As Sijmen showed earlier in the presentation, we’re off to a very strong start in the U.S |
| And as Steve mentioned, this has led to a strong start for Joenja |
| And I think that’s really helped in identifying new patients |
| Gross profit increased to $146 million |
| Let’s start with RUCONEST and a strong quarterly sales print |
| And I think certainly some physicians are quite excited by what may be coming in the future |
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| And this is really frustrating for patients and doctors because they have patients who have clinical symptoms of APDS often, but the genetic test result is inconclusive |
| Some of that is just due to lack of awareness even amongst patients about the genetics of the disease, and some of that is just due to the healthcare system, idiosyncrasies and how it’s difficult to get genetic testing done |
| And as you’re all aware, the HAE market underwent a significant event, which affected all products |
| Consequentially, the operating loss was $6.5 million for the three-quarter period |
| So you will remember that in Q1, there was a temporary reimbursement issue was a market circumstance |
| And I think the nice thing here in a sense is that, this is a problem – it’s a new problem for APDS, but we’re really using a playbook that exists already for many other genetic diseases |
| And particularly in the US, you don’t expect to encounter a problem with the last 10% or 20% because of lack of insurance coverage |
| And what these are genetic test results that are basically unclear or, I would better say, unclassified at this point, and with the growth in genetic testing, we get more of these inconclusive results |
| So although we see disruption and as I mentioned earlier, we see sometimes a decrease or in some places, even a normalcy increase in utilization |
| They have tolerability issues and they’re not quite the perfect target for the condition itself |
| But through all of the disruptions, certainly since I joined Pharming seven years ago, we see that initial period of disruption and fluctuation in volume |
| And as I mentioned earlier, the continued need for IV C1 esterase inhibitors despite that quite disruptive changes to the market |
| This makes the challenge of diagnosis even more difficult beyond just a rare disease |
| Some of the features of APDS that we see, where else do we see that type of problem in the immune system |
| The disease manifests itself in childhood and worsens over time without anything specifically indicated for treatment; physicians and patients who are quite limited in their treatment options |
| will, as you know, for the most part, always be lower |
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