PNH is market driven by both efficacy and safety, which is reflected in these continued strong results. As Cedric mentioned, we are excited about the approval of the EMPAVELI Injector. The field teams are now working to transition existing patients onto the injector. Initial feedback has been positive and we look forward to bringing the injector to more and more patients over the coming months. We are also focused on bringing EMPAVELI to new patients who may benefit from this treatment and reinforcing the long-term safety and efficacy data and real world experience. Now, I will turn the call over to Caroline.
Caroline Baumal: Thanks, Adam, and good morning everyone. We have had a significant presence these past few months at multiple medical meetings including the ASRS Annual Meeting, EURETINA and the Retina Society meeting. The reactions and feedback we are hearing from the medical community, especially in these last several weeks, support the solid performance of SYFOVRE and its continued growth. As shown on Slide 8, at ASRS we presented for the first time the 30-month results of our GALE extension study, deepening our understanding of the long-term efficacy of SYFOVRE. These data continue to demonstrate increasing effects with SYFOVRE out to 30 months and a safety profile consistent with previously reported clinical data. In GALE SYFOVRE reduced GA lesion growth with both monthly and every other month treatment compared to the projected sham arm with an even more pronounced effect in patients with nonsubfoveal lesions, the greatest effect shown by any GA therapy to date.
Additionally, we continue to build on the functional data supporting the efficacy profile of SYFOVRE. We recently presented our third functional analysis showing a visual function benefit. In this post-hoc microperimetry analysis data showed that SYFOVRE extended foveal light sensitivity in the Phase 3 OAKS study, which is critical for prolonging visual function. We also presented an updated covariate adjusted analysis of visual acuity data at the Retina Society from our GALE long-term extension study. As we saw with the 24-month data at ARVO, we continue to see favorable trends on best corrected visual acuity in patients in the continuous cycle retreatment arms as compared to patients on sham for two years who then crossed over to active treatment in GALE.
Both of these analyses add to the overall efficacy profile pegcetacoplan. We are looking forward to presenting at the upcoming American Academy of Ophthalmology meeting this weekend in San Francisco. At this meeting we will share 36-month data from our GALE extension study further demonstrating SYFOVRE’s long-term efficacy and increased effects over time and a consistent safety profile out to three years. As seen on Slide 9, we are also presenting new data this weekend at Kidney Week from the Phase 2 NOBLE study investigating pegcetacoplan for the treatment of post-transplant recurrence of IC-MPGN and C3G. IC-MPGN and C3G are rare, debilitating kidney diseases that are estimated to affect 5000 people in the United States and up to 8000 in Europe with no approved treatments available.
What is particularly striking in these data, as shared in our recent press release, is how quickly pegcetacoplan showed the potential for a treatment effect in transplanted kidneys that had disease recurrence. In just 12 weeks, 80% of patients treated with pegcetacoplan showed a reduction in C3c staining by at least one order of magnitude of intensity from baseline. 50% showed a reduction in C3c staining by two or more orders of magnitude, which was the primary endpoint of the study, and 40% showed 0 staining intensity, indicating that C3c deposits were cleared. The image on this slide is an example of one patient. You can see the disease activity or C3c staining at baseline on the left with the immunofluorescence or bright green areas lit up.
At week 12, you can see in the second image that it’s gone. This magnitude of C3c clearing in the kidney has never been shown before. Additionally, treatment with pegcetacoplan showed improvements across key clinical measures including proteinuria and stable kidney function. While this was a small study, these data indicate that pegcetacoplan is targeting the underlying cause of the disease, strengthening our confidence in pegcetacoplan as a potential treatment for both native and post-transplant forms of these rare and serious diseases. We are currently enrolling patients in our Phase 3 VALIANT study evaluating pegcetacoplan in adolescent and adult patients with native and post-transplant recurrent IC-MPGN and C3G. Investigators in this study have been enthusiastic about bringing in new patients.
We anticipate completing enrollment by the end of this year with top line results expected in the third quarter of 2024. Now I will turn the call over to Tim for a review of the financials. Tim?
Tim Sullivan: Thank you, Caroline. Total revenue for the third quarter was $110 million, which consisted of $24 million in EMPAVELI U.S. net product revenue, $75 million in SYFOVRE U.S. net product revenue and $11 million in collaboration revenue from Sobi. As a reminder, revenue is recognized as shipments to the distributor and therefore includes any product in inventory at the distributor as well as product shipped to the physician by the distributor. We continue to estimate approximately two to three weeks of inventory on hand at the distributor and expect these inventory levels to be consistent going forward based on anticipated demand. Turning to the rest of the P&L, R&D expenses were $79 million and G&A expenses were $146 million and we reported a net loss of $140 million.
I’d like to point out a few items in our financial statements that will help in evaluating our business. First, cost of goods sold was $22.4 million for the third quarter, higher than in previous periods due to milestone payments to Penn and purchase price variances, combined totaling approximately$ 8.6 million. Second, we recorded accounts receivable of $169.3 million, which is also higher than previous quarters and is primarily associated with payment terms that we provide to the SYFOVRE distributors. The accounts receivable line item has increased as SYFOVRE sales have increased and is in line with those payment terms. Third, we are now categorizing a majority of medical affairs and certain other costs in G&A instead of in R&D. This represents an approximately $19 million shift from R&D to G&A in the current quarter.
