Christopher A. Viehbacher
President and Chief Executive Officer at Biogen
Thank you, Steve. Good morning, everyone.
I'll start first by thanking you, Steve, for stepping up as Interim Head of IR and done a great job of preparing us for this quarter. Also, earlier this week, we announced the retirement plans of our CFO, Mike McDonnell, and also the appointment of his successor, Robin Kramer. But Mike is still very firmly in the saddle as CFO, and we will be recognizing his significant contribution to Biogen with the fourth quarter earnings call later.
So, I think Biogen has made significant and very strong progress over the last two years, and I do think the Company is well-positioned for the future. Our launches are progressing well, with good sequential quarter-over-quarter growth. Our cost base has been significantly reduced, but more importantly, a value from money approach to spending, I think, has been embedded in our culture. The acquisitions we've done to date have been well-received and are already creating value. And I think we have a strong late-stage pipeline emerging.
So, if we turn first to the launches, let's start talking about LEQEMBI. Now, although LEQEMBI revenue in the U.S. continues to be below the expectations of our collaboration and the prescriber base has not expanded to the extent that we had anticipated, global revenue still grew by 66% in the third quarter as compared to the second quarter, and we've got continued uptake outside the U.S. and new prescriber growth of nearly 40% in the U.S. The collaboration continues to refine the commercial strategy and we are seeing benefits from an increase in our sales-force, really who started out there in the field from 1st of September. And we continue to evaluate opportunities to potentially accelerate our business.
Now, we've continued to see some healthcare systems who are treating expand and extend -- and expanding their -- and extending their treatment sites in the U.S. And more recently, we're starting to see large infusion networks activating in high population geographies to help absorb patient demand. We've been encouraged by the rate of uptake outside the U.S., including Japan, where revenue nearly doubled from the previous quarter. And I think there's been terrific launch activities, in particular Japan and China. It does seem like a single-payer system, has also enabled that kind of growth. And overall, we expect continued sequential growth quarter-on-quarter for LEQEMBI over the near-term.
We believe there are a few future potential catalysts that could accelerate uptake, including the potential availability of IV maintenance as soon as next year. A subcutaneous formulation for maintenance and eventually induction and more widespread utilization of blood-based diagnostics. Just to underline how much of a lift this is for physicians, some of you may have noted an opinion piece in JAMA Neurology dated October 14, that was written by Katherine Possin of UCSF, Jeff Burns at University of Kansas, and Brent Forrester at Tufts. They talk about the unprecedented time of advances, but equally, they say the challenge and the importance of translating scientific advances in diagnostics, treatment and care into practice in a timely and equitable manner cannot be overemphasized. Innovation at the clinic, healthcare system and policy levels is necessary to equitably translate advances at-scale. So, we continue to believe that this is going to be an important market. But again, we don't believe that we have a demand issue. It is just taking the healthcare system time to actually adapt to treating this number of patients.
Turning to SKYCLARYS. We saw increased demand globally, as we broadened our footprint, particularly in Europe. SKYCLARYS is now generating revenue from both commercial and other paid mechanisms in 15 markets outside the U.S. This includes a number of countries in the EU, where we are seeing increased demand quarter-over-quarter. Now, at this point, I'd like to say, there is a difference between how we generate revenue in the U.S. and how we're seeing demand develop in Europe. In the U.S., our revenue is rising at the rate we find patients. In Europe, we are actually already out there commercializing the product and we have a number of early access programs in-place. But the strategy for a lot of products in Europe is to get patients on-board, while you're negotiating with governments to get reimbursement. And at some point, then the governments reimburse those patients and you have an immediate population of patients ready to go, because they are already on treatment.
So, when you're looking at the progression quarter-on-quarter, the ex-U.S. piece is not going to be a reflection of growing demand, but it's going to be a reflection of at what point in time do we get reimbursement for governments. But I can tell you that we are adding patients every day, every week in Europe at a pace that has exceeded our expectations. Now, we are looking to expand access to more patients and there are now 11 regulatory filings that have been submitted globally. So, we're looking now beyond the U.S. and Europe, and they could start generating revenue as soon as next year.
ZURZUVAE continues to outperform our expectations commercially in the U.S., where we saw $22 million of revenue in the third quarter, and that's an increase of 49% over the second quarter, driven, in part, by a 40% increase in patients this quarter. I think the team has done an outstanding job with this launch.
In all of the cases, we've been talking about LEQEMBI, SKYCLARYS, ZURZUVAE, I just remind everybody that these are not pre-existing markets. We're building these markets in each case. And that always takes longer than having incremental innovation where you go in and you just are looking to take some market share from a pre-existing market.
So, if we could change the slide, Steve. Our goal is really for sustainable growth, and there's short-term and there's medium-term growth. When I came to the Company, I had really three major objectives. One is to put Biogen back onto a sustainable growth pattern for revenue, to build a pipeline that can sustain that growth for Biogen well into the 2030s, and also to build a pipeline of leaders who will take this Company to even more success in the 2030s.
So, as we look at the pipeline, I have to say, I think we are very excited about what we see emerging. Again, we are Biogen. We don't do incremental innovation. But I think there are some really interesting products that we feel very good about, because unlike a lot of products in the past with Biogen, where we go into Phase 3 and we don't really know whether they're going to work, I think we've seen an awful lot in biomarkers, in data and other indications that suggest there's a -- we have a growing conviction in these assets.
So, BIIB080, one of the things that excites me is that, although this is an intrathecal, as Priya will say, we recruited early on this one, and we're finished recruiting. And to me, as someone who's had more -- commercial experience over 35 years, when I see a clinical trial recruiting early, particularly in a competitive space where there are existing therapies, that augurs well for the product downstream.
Dapirolizumab, we saw positive Phase 3 results, and I'd like to congratulate Priya, because Priya had already thought about this and it's worked with UCB and there's actually a Phase 3 protocol ready to go. And so, we'll be starting Phase 3 very soon. Lupus is an area of huge unmet need and we have not only dapi, but we have litifilimab in two indications. And behind that, we have also felzartamab actually in lupus nephritis. And felza, we had some very encouraging data at San Diego in IgAN and we've had Breakthrough status on AMR. This is a game-changer for us in terms of our pipeline, because, again, here we've got Phase 2 data that look very compelling. We all know that there are no guarantees in pipeline development. But at least we have, I think, a reason to believe that these products could come to market and make a big difference.
And as we start to look at the peak revenue for each of these products, the cumulative of all of these, if they all actually made it to market and got approved, have peak sales cumulatively of about $14 billion. And when you consider that our pharma business today is about $7.5 billion, this late-stage pipeline could really transform Biogen over the longer-term. But I shouldn't really be talking about pipeline. The real expert is Priya.
And so, with that, I'm going to turn it over to Dr. Singhal.
