Cuộc họp báo cáo kết quả kinh doanh Quý 3/2026 của Kiniksa Pharmaceuticals (KNSA): Nâng dự báo ARCALYST

Kiniksa Pharmaceuticals (NASDAQ: KNSA) đã báo cáo ARCALYST tiếp tục tăng trưởng trong quý 3 năm 2026 và nâng dự báo doanh thu cả năm. Ban lãnh đạo cũng đưa ra mốc thời gian công bố dữ liệu vào nửa sau năm 2027 cho nghiên cứu giai đoạn 3 bản chốt của KPL-387.

Điểm tin chính

• Doanh thu ARCALYST tăng 58% so với cùng kỳ năm trước lên 286 triệu USD, nhờ việc gia tăng mức độ tiếp nhận từ bệnh nhân và bác sĩ.
• Kiniksa đã nâng dự báo doanh thu ARCALYST năm 2026 lên mức 1,045 tỷ - 1,050 tỷ USD.
• Lợi nhuận hoạt động đạt 54,2 triệu USD, trong khi lợi nhuận ròng đạt 47,3 triệu USD. Công ty đã tạo ra khoảng 43 triệu USD tiền mặt ròng trong quý.
• Tỷ lệ thâm nhập của ARCALYST đạt 23% trên tổng số 14.000 bệnh nhân tái phát nhiều lần hàng năm, so với mức 18% vào cuối năm 2025.
• Kiniksa dự kiến thu được dữ liệu giai đoạn 3 bản chốt cho KPL-387 vào nửa sau năm 2027 và hướng tới khả năng ra mắt trong khoảng thời gian 2028-2029, tùy thuộc vào tiến trình lâm sàng và pháp lý.
• Công ty dự kiến sẽ bắt đầu thử nghiệm Giai đoạn 1 cho KPL-1161, một chất ức chế IL-1 alpha và beta tiềm năng dùng mỗi quý một lần, vào cuối năm 2026.

Dữ liệu tài chính chính

Chi phí hoạt động tăng do giá vốn hàng bán và chi phí hợp tác gắn liền với doanh thu ARCALYST cao hơn, chi phí nghiên cứu và phát triển KPL-387 tăng thêm, cũng như khoản đầu tư bán hàng, quản lý doanh nghiệp lớn hơn để hỗ trợ thương mại hóa.

Kết quả kinh doanh và hoạt động

ARCALYST tiếp tục là động lực tăng trưởng chính của Kiniksa. Tỷ lệ thâm nhập 23% áp dụng cho khoảng 14.000 bệnh nhân bị tái phát từ hai lần trở lên hàng năm. Ban lãnh đạo cũng xác định thêm một nhóm bệnh nhân hàng năm gồm khoảng 26.000 người bị tái phát lần đầu.

Mạng lưới bác sĩ kê đơn đạt khoảng 5.450 vào cuối quý 3, tăng khoảng 450 so với quý trước. Khoảng 30% là các bác sĩ tái kê đơn, với nhóm này mở rộng thêm khoảng 170 người trong quý. Dựa trên nghiên cứu thị trường lịch sử của công ty, khoảng 80% đơn thuốc đến từ bệnh nhân tái phát nhiều lần và 20% từ bệnh nhân tái phát lần đầu.

Ban lãnh đạo cho biết các bác sĩ ngày càng xem xét sử dụng ARCALYST sớm hơn trong quá trình diễn tiến bệnh, bao gồm sau khi dùng NSAID và colchicine nhưng trước corticosteroid. Khoảng 50% bác sĩ được khảo sát ủng hộ hướng tiếp cận này, gấp đôi mức ghi nhận trong ba năm trước khi hướng dẫn lâm sàng tóm tắt năm 2025 của Trường Đại học Tim mạch Hoa Kỳ được công bố.

Kiniksa đang sử dụng AI và học máy để tối ưu hóa việc tiếp cận bác sĩ và bệnh nhân mục tiêu. Chiến dịch tiếp thị trực tiếp tới người tiêu dùng Heart’s Home của công ty đã mang lại lượng truy cập vào trang web ARCALYST tăng 12 lần và số phiên tương tác tăng 8 lần so với mức trước chiến dịch. Khoảng 55% bệnh nhân xem quảng cáo hoàn toàn đồng ý rằng họ có thêm động lực để thảo luận về ARCALYST với chuyên gia y tế của mình.

Nghiên cứu giai đoạn 3 bản chốt đối với KPL-387 tiếp tục tuyển chọn và dùng thuốc cho bệnh nhân thông qua mạng lưới trung tâm toàn cầu. KPL-387 đang được phát triển dưới dạng liệu pháp tiêm dưới da liều 300 miligam mỗi tháng một lần cho bệnh viêm màng ngoài tim tái phát.

Một nghiên cứu chuyển sang đơn trị liệu riêng biệt đang đánh giá cách bệnh nhân chuyển từ NSAID, colchicine, corticosteroid hoặc chất ức chế con đường IL-1 sang KPL-387. Nghiên cứu bao gồm giai đoạn tiêu chí chính kéo dài 16 tuần và nhằm cung cấp thông tin cho phần nội dung hướng dẫn liều dùng và cách sử dụng.

Ban lãnh đạo đã trích dẫn nghiên cứu về hồ sơ sản phẩm mục tiêu, trong đó khoảng 75% bệnh nhân ưu tiên dạng dung dịch tiêm hàng tháng tiềm năng của KPL-387 hơn các liệu pháp thương mại hiện tại hoặc các liệu pháp thử nghiệm khác. Ngoài ra, 92% chuyên gia y tế được khảo sát cho biết có khả năng cao sẽ kê đơn theo hồ sơ mục tiêu này. Những phát hiện này phản ánh nghiên cứu thị trường thay vì kết quả lâm sàng.

Dự báo của ban lãnh đạo

Ban lãnh đạo dự kiến thu được dữ liệu giai đoạn 3 của KPL-387 vào nửa sau năm 2027 và nhận thấy khả năng ra mắt thương mại vào năm 2028-2029. Kiniksa cũng dự kiến KPL-1161 sẽ bước vào thử nghiệm Giai đoạn 1 vào cuối năm 2026.

Rủi ro và yếu tố cần theo dõi

• Hiệu quả của KPL-387 vẫn chưa được chứng minh trong thử nghiệm Giai đoạn 3 bản chốt đang diễn ra. Tiến độ phát triển và khả năng ra mắt vào năm 2028-2029 vẫn chỉ là kỳ vọng của ban lãnh đạo.
• Tiềm năng thương mại của KPL-387 phụ thuộc vào dữ liệu, bao gồm kết quả của các nghiên cứu bản chốt và nghiên cứu chuyển đổi.
• Việc mở rộng thâm nhập sâu hơn của ARCALYST đòi hỏi phải tiếp cận nhóm bệnh nhân viêm màng ngoài tim tái phát phân bố rải rác về mặt địa lý, cũng như tiếp tục đầu tư vào đào tạo bác sĩ, triển khai thực địa và tiếp cận người tiêu dùng mục tiêu.
• Chi tiêu cho R&D và SG&A đang tăng lên khi Kiniksa thúc đẩy các sản phẩm trong đường ống phát triển và mở rộng thương mại hóa ARCALYST.

Điểm nổi bật trong phần Hỏi & Đáp với chuyên gia phân tích

• Tiến độ của KPL-387: Ban lãnh đạo lý giải sự tự tin vào mục tiêu dữ liệu nửa sau năm 2027 là nhờ hoạt động tuyển chọn bệnh nhân tích cực, việc phân liều cho bệnh nhân, mạng lưới trung tâm toàn cầu và sự tương tác trực tiếp với các nghiên cứu viên.
• Tỷ lệ thâm nhập của ARCALYST: Ban lãnh đạo cho biết họ chưa ghi nhận sự thay đổi đáng kể nào về đặc điểm nhân khẩu học của bệnh nhân hoặc độ nghiêm trọng của bệnh. Cơ hội còn lại bao gồm cả bệnh nhân tái phát nhiều lần và những người tái phát lần đầu.
• Chi tiêu thương mại: Công ty mô tả các khoản đầu tư thực địa và tiếp thị trực tiếp tới người tiêu dùng (DTC) của mình mang tính tập trung thay vì dàn trải, với chi tiêu tập trung vào các bệnh nhân có khả năng bị viêm màng ngoài tim tái phát và các chuyên gia y tế liên quan.
• Chiến lược chuyển đổi KPL-387: Nghiên cứu chuyển giao nhằm cung cấp cho bác sĩ hướng dẫn thực tế để chuyển bệnh nhân từ các liệu pháp đường uống, corticosteroid hoặc chất ức chế IL-1 khác sang đơn trị liệu KPL-387 hàng tháng.
• KPL-1161: Ban lãnh đạo cho biết đặc tính liều dùng tiềm năng mỗi quý một lần có thể hỗ trợ điều trị các bệnh mạn tính hoặc kéo dài suốt đời, trong khi vẫn duy trì trọng tâm trước mắt là bắt đầu thử nghiệm Giai đoạn 1.
• Phân bổ vốn: Kiniksa tiếp tục đánh giá các cơ hội phát triển kinh doanh nội bộ và bên ngoài, nhưng ban lãnh đạo cho biết hoạt động kinh doanh thương mại và đường ống phát triển hiện tại đã đặt ra tiêu chuẩn rất cao cho các giao dịch.

Toàn văn Biên bản Cuộc họp Báo cáo Kết quả Kinh doanh

Toàn văn cuộc gọi công bố kết quả kinh doanh

Phần trình bày của ban lãnh đạo

Operator

Thank you for standing by, and welcome to the Kiniksa Pharmaceuticals Third Quarter 2026 Earnings Conference Call. [Operator Instructions] As a reminder, today's program is being recorded.

And now I'd like to introduce your host for today's program, Jonathan Kirshenbaum, Investor Relations. Please go ahead, sir.

Jonathan Kirshenbaum

Thank you, operator. Good morning, everyone, and welcome to the Kiniksa Pharmaceuticals Third Quarter 2026 Earnings Call. A press release highlighting our financial results and recent portfolio execution can be found on our website under the Investors section.

As for the agenda, our Chief Executive Officer, Sanj K. Patel, will start with an introduction. From there, Ross Moat, our Chief Operating Officer, will provide an update on ARCALYST commercial execution. After that, Mark Ragosa, our Chief Financial Officer, will review our third quarter 2026 financial results. And finally, Sanj will return at the end of the call to share closing remarks and kick off the Q&A session, for which John Paolini, Kiniksa's Chief Medical Officer, will also be on the line.

Before getting started, please note that we will be making forward-looking statements today that are subject to risks and uncertainties that may cause actual results to differ materially from such statements. A review of these statements and risk factors can be found on this slide as well as under the caption Risk Factors contained in our SEC filings. These statements speak only as of the date of this presentation, and we undertake no obligation to update such statements, except as required by law.

With that, I'll turn it over to Sanj.

Sanj Patel

Thanks, Jonathan, and good morning or good afternoon, everyone. Over the last 10, 11 years, we've built this company through multiple stages of growth. And today, I'm as excited as ever about what the team and I can accomplish together in the years ahead. Kiniksa continues to build a leading IL-1 alpha and beta inhibition franchise, driven by the commercialization of ARCALYST in recurrent pericarditis as well as our progress with KPL-387 and KPL-1161. This morning, we announced via a press release that we've raised our full year revenue guidance to between $1.045 billion and $1.050 billion. We continue to see robust growth with ARCALYST in recurrent pericarditis driven by strong execution and strategic investments across the business.

On the clinical side, we're excited about the progress of KPL-387 and KPL-1161. The pivotal Phase III study with KPL-387 continues to enroll and dose patients. We announced today that we expect data from this trial in the second half of 2027. The team and I are really looking forward to potentially launching this drug in the '28, '29 time frame. In addition to providing an important treatment option for patients with recurrent pericarditis, we believe KPL-387 could help grow the market by enabling a once-monthly subcu dosing. We're also on track to have KPL-1161, our quarterly IL-1 alpha and beta inhibitor in a Phase I clinical trial by the end of this year. Importantly, Kiniksa's robust financial profile allows us to continue to invest in penetrating the recurrent pericarditis market and growing the IL-1 alpha and beta inhibition franchise, whilst also pursuing additional value-creating opportunities.

In the third quarter, we saw a continuation of strong ARCALYST momentum with Q3 revenue of $286 million. The penetration rate into the annual population of 14,000 multiple recurrence patients increased to 23% as of the end of Q3. As shown by the increased breadth and depth of prescribing over time, adoption of IL-1 alpha and beta inhibition continues to expand among the approximately 40,000 recurrent pericarditis patients each year. The underlying fundamentals that propelled our commercial success remains strong. Since launch, we've observed robust payer approval, strong patient compliance and greater appreciation of the need to treat throughout the multiyear duration of the disease. Underpinning this growth is strong execution by our commercial organization and data-driven investments in ARCALYST.

Our AI supported patient identification initiatives and targeted direct-to-consumer campaign, Heart's Home, have positively contributed to growing patient and physician awareness of recurrent pericarditis and the important role of IL-1 alpha and beta inhibition in controlling this debilitating disease. As you've heard, we now expect ARCALYST to achieve over $1 billion in revenue in 2026, and we look forward to continuing to bring this blockbuster drug to more patients suffering from this debilitating disease. In order to grow the recurrent pericarditis market over the next several years, we plan to drive greater adoption in both the 14,000 multiple recurrence patients annually and the additional 26,000 patients annually that are experiencing their first recurrence. Kiniksa is executing against its strategy to help more patients, drive more ARCALYST growth and advance KPL-387 and KPL-1161. This trajectory will help put the company on a path to having multiple commercial products, continued strong and profitable growth and the flexibility to invest in future value creation. I can tell you that the team and I won't rest until we've helped many, many more patients.

And now our President and COO, Ross Moat.

Ross Moat

Thank you, Sanj. As you've heard, we're pleased with the continued strength of our commercial performance with ARCALYST, and we are even more excited by the substantial growth opportunity ahead. We continue to be highly focused on further increasing the penetration rate into the many thousands of recurrent pericarditis patients and continuing to evolve the treatment paradigm towards interleukin-1 alpha and beta inhibition.

As illustrated on the left side of this slide, physicians continue to report an increasing consideration of ARCALYST earlier in the disease course, including at the first recurrence. Additionally, we also see a growing appreciation for ARCALYST to be utilized earlier in the line of therapy, meaning after NSAIDs and colchicine and importantly, prior to corticosteroids as ratified in the 2025 American College of Cardiology concise clinical guidance for recurrent pericarditis. In fact, approximately 50% of physicians surveyed now support this treatment approach, representing a doubling from levels over the last 3 years prior to the publication of this independent guidance.

As we continue to build and lead this market, our team are laser-focused on value-driven investments that aim to increase market penetration and help many more patients. Increasing education and awareness on recurrent pericarditis, ARCALYST and the new treatment paradigm remain critical components of our strategy, and we've enhanced our capabilities through the use of AI and machine learning to reach a larger audience. On the health care professional side, we've done this through improving our data sources to inform us not only which health care professionals we should be seeing, but importantly, when we should be seeing them. On the patient side, we've seen encouraging early indicators from our Heart's Home direct-to-consumer campaign. Based on this initial traction, we plan to expand the campaign with additional content and outreach initiatives aimed at empowering more patients to engage with their health care professionals about ARCALYST.

As a reminder, Heart's Home is a highly targeted DTC campaign where we've innovated from traditional DTC by using AI to produce and deliver a campaign that's effective for a rare disease audience. This campaign is aimed at educating an enriched population of likely recurrent pericarditis patients who are currently not taking ARCALYST and empowering them to discuss ARCALYST with their health care provider. As an early indicator of the impact of this campaign, we've seen a 12-fold increase in the traffic to our ARCALYST website compared to baseline levels prior to the campaign. Additionally, there's been an eightfold increase with engaged sessions, meaning visits where the individual spends meaningful time on the website or interacts with the content. More importantly, approximately 55% of patients who saw the ad strongly agreed that they are motivated to speak with their healthcare provider about ARCALYST.

All of these indicators are strong signals that our digital strategy is reaching the right audience and is empowering action. As this disease has a very high annual incidence rate of patients coming into the labeled indication, this DTC initiative is nicely supplementing our robust execution in the field and helps us to address the substantial opportunity that we have ahead to help many more patients. As previously mentioned, our interleukin-1 alpha and beta inhibition franchise is growing, is profitable and has significant opportunity in the months and years ahead.

With that, I'll turn the call over to Mark to review our financial results.

Mark Ragosa

Thanks, Ross. Our third quarter delivered continued ARCALYST sales growth, advancement of KPL-387 and KPL-1161 development and a solid financial position. This morning, I'll review our financial results and key performance drivers. Detailed financial information is available in today's press release.

Starting with the income statement, ARCALYST revenue grew 58% year-over-year to $286 million in the third quarter, driven by continued gains in patient and physician adoption. Operating expenses increased year-over-year, driven by higher ARCALYST revenue, which resulted in additional cost of goods sold and collaboration expenses, advancement of KPL-387 development, which drove additional R&D investment and support of ARCALYST's commercialization to reach more patients, which led to additional SG&A investment. Operating income rose to $54.2 million and net income to $47.3 million, both up significantly year-over-year.

Turning to the calculation of ARCALYST collaboration profit, which drives total collaboration expenses on our income statement. ARCALYST's collaboration profit increased 67% year-over-year to $211.6 million, outpacing sales growth and reflecting disciplined commercial investment. Next, we ended the third quarter with $568.8 million in cash, reflecting approximately $43 million in net cash generation during the quarter.

Looking ahead, in addition to our updated 2026 ARCALYST sales guidance of $1.045 billion to $1.050 billion, we are providing full year R&D and SG&A expense guidance. We expect full year R&D expenses of $160 million to $170 million in 2026. This range includes continued development of KPL-387 and KPL-1161 as well as significant fourth quarter KPL-387 pre-commercial manufacturing costs. We expect full year SG&A expenses of $270 million to $280 million in 2026. This range supports continued ARCALYST commercialization, including additional personnel and promotional activities in the fourth quarter to further build disease awareness and enhance patient and physician targeting.

In closing, our third quarter results show the strength of our operating plan, a growing and profitable ARCALYST business, funding the advancement of key development assets and positioning us to create value in the near and long term.

With that, I'll turn the call back to Sanj for closing remarks.

Sanj Patel

Thanks, Mark. As you've heard, Kiniksa is generally well positioned to build significant future value as we grow our IL-1 alpha and beta inhibition franchise. The team and I are on it and focused on helping as many patients as possible with ARCALYST and to advancing the development of our clinical portfolio in order to bring additional therapies to patients.

With that, I'll turn it back to the operator for questions. Thank you.

Operator

And our first question for today comes from the line of Anupam Rama from JPMorgan.

Phần hỏi đáp

Anupam Rama

Congrats on the quarter. I just wanted to ask a quick KPL-387 question. I think the guidance for pivotal data in the second half of 2027 is new today. So can you tell us what you're seeing in terms of enrollment dynamics and where you are on site initiation that give you confidence to laying out this time line?

Sanj Patel

Thanks, Anupam. I think John Paolini will answer that. Suffice to say that our execution across not just commercial but also the clinical development organization. And as I've said before, we are enrolling and dosing patients. It's a global clinical study with global sites. And both myself, John and Ross take pride in meeting with investigators and just getting them excited about the future. So there's been some massive momentum, both internally and with our investigators. And as with ever, we go at things with full force, and that's what the guidance is around as having results in the second half of next year. But John?

John Paolini

I think that's excellent guidance from Sanj. The only thing that I would add is that on clinicaltrials.gov, you can see the extent of the global nature of our program. And so the sites that are involved in the program across the world are all listed there. And so you can see the scope of effort. And as Sanj mentioned, we are on the ground and engaging with clinicians, and we can feel the excitement about the program, and so we continue forward.

Sanj Patel

I'd also say we have a crack clinical operations team and having run clinical operations for many years at Genzyme before I run commercial, I've got a very high bar for clinical research and clinical operations. And after many, many years, I feel like we've really got the best team to do the job.

Operator

And our next question comes from the line of Edward Nash from Canaccord Genuity.

Edward Nash

Really excited to see that over $1 billion number now for the guidance. So congratulations. I just wanted to ask now you're at 23% active penetration, that's 2% higher than last quarter, which is really, I think, impressive. Can you maybe give us an idea of how we should think about the shape of the penetration curve from here? Is there anything structurally different about the next quartile of patients versus the patients you've already converted? You're going up on the SG&A number, which makes a lot of sense. And you put a lot of focus on the DTC campaign, which clearly seems to be paying off. Just kind of curious as to how many extra dollars need to be put in to kind of achieve greater uptake of scripts.

Ross Moat

Thanks, Edward. This is Ross. So thanks very much for your comments. And yes, we're pleased to announce that we were around 23% at the end of the quarter in terms of penetration into the multiple recurrence group, which is the patients that have suffered for 2 or more recurrences. And that's without allocating anything to the first recurrence group, which we've got about 20% of our prescriptions in the first recurrence group also. So the opportunity is very significant. While on one hand, we're happy with the 23%, and that's obviously showing a couple of percent growth versus the end of Q2 number when we shared it. The time before that, the last time we shared the penetration number, I think it was at the end of Q4, which was 18% at the end of last year. So that's been growing relatively nicely. But I think more importantly is the opportunity that's ahead. I mean, clearly, there are a lot of patients in the 2-plus recurrence group that we still got to help and as I said, not allocating for even those that are in the first recurrence. And as we shared from some of the market research today, the propensity and the desire for physicians to look and treat patients with IL-1 alpha and beta inhibition in the first group has also been growing quite substantially over time. So we think the future is very bright from that perspective.

In terms of kind of different patient groups, aside from the recurrence number, there's really not much else to report. We're not seeing a significant change necessarily in the demographics of the patients or severity levels or anything else. It's just that this is a rare flare in cardiovascular disease. There are a lot of patients out there relative to a rare disease. And we're trying to get out and reach as many patients as possible. We know that they are widely dispersed around the country, and that takes a certain effort, as you have alluded to, from our sales and marketing spend and so on. But our efforts are ultimately on value-driven investments that can make sure we reach those physicians and switch more and more of them on to this new way of treating and ultimately get greater penetration into this opportunity to ultimately help more patients.

Edward Nash

I'm sorry, go ahead.

Ross Moat

Yes. No, Edward, maybe just to add the final part as well is that the DTC spend and field team spend that we have, and we've announced in our guidance looking forward as well is ultimately very efficient. We are very focused on this as a rare disease market. And for the DTC side of things, this is not kind of broad spectrum massive spend DTC. It's very efficient, very targeted type of expenditure to address appropriately the market that we have.

Operator

And our next question comes from the line of Paul Choi from Goldman Sachs.

Kyuwon Choi

Congratulations on the great quarter, and congrats Ross as well on the new title. I want to ask on the 387 switch strategy. And I was wondering if you could just sort of provide a little more color on where you are with progress on that. And I guess what the ultimate data you are looking for there to support 387 from an insurance perspective?

And my second question is on 1161. Maybe just where are you thinking in terms of indication selection, I guess, at this point and a little bit more on the criteria that you're considering for the first indication there for 1161?

John Paolini

Thank you, Paul. I appreciate your questions. This is John. So with regard to the KPL-387 transition to monotherapy dosing and administration study, I mean, this study is designed primarily as what we call a posology study. So it covers dosing administration specifically for informing the label. So it's designed, as you can see in the slides, for looking at how patients are coming from stable therapies, whether they're oral or biologic and then transitioning to KPL-387 monotherapy at the 300-milligram subcutaneous monthly dose level. And so that's really what that study is designed to do. It follows very similarly the precedent of what's in the ARCALYST label, which similarly describes the transitions from NSAIDs, colchicine, corticosteroids and anakinra. So this is just really following in that tradition. So that's how the study is designed and the data that will be generated.

But I'll turn it over to Ross to talk about ultimately other elements of transition.

Ross Moat

Yes. Thanks very much, John. I mean, I guess just to say that, obviously, we're very excited about the potential for KPL-387, but everything is kind of data dependent as we move forward. But when we tested the target product profile for KPL-387, both with health care professionals and patients, we were really very encouraged by the feedback that we had back while we believe that ARCALYST has a lot of growth left in it to address the recurrent pericarditis opportunity. With KPL-387, patients did tell us that around 75% of them would prefer the KPL-387 target profile being a monthly liquid formulation, potentially autoinjector over current commercial or other investigational therapies. They also reported a propensity for a greater number of patients to start on therapy with that target product profile as well as staying on therapy longer. And then when you looked at the health care professional side, 92% of health care professionals indicated a high likelihood to prescribe KPL-387 with that target product profile over available commercial or other investigational therapies. So that, I think, reads quite positively about the future. But ultimately, we are focused on conducting the clinical research and awaiting the data.

John Paolini

And then with regard to your question about 1161, so we're very excited about this program, which has the potential for once quarterly dosing, again, targeting the IL-1 alpha and beta signaling by targeting the receptor. And so this program, we expect to begin a Phase I program by the end of the year. And to that extent, we have not yet announced or disclosed our plans with regard to development indications. Suffice it to say, though, that with that longer duration of action, that really unlocks a lot of potential for disease states, especially those that are chronic or lifelong in nature by virtue of the once-quarterly dosing.

Ross, anything to add?

Ross Moat

No. That's great.

Operator

And our next question comes from the line of Roger Song from Jefferies.

Unknown Analyst

This is Peter calling in for Roger. Congrats on a good quarter. Just a couple of quick ones from us. For third quarter, can you tell us what share of the new patients came from first time versus repeat prescribers? And can you also share whether -- or how much growth you've seen within the first recurrence patients as well for this quarter?

Ross Moat

Yes. Peter, thanks very much for the questions. We don't share some of that data directly externally. But of course, it's the type of thing that we look at a lot internally in the business. What we have shared is in Q3, clearly, we've seen a substantial uplift in the number of patients, representing a strong growth of $42.5 million quarter-on-quarter. And ultimately, that's driven by strong prescriber growth.

What we have said is that when you look at the total number of prescribers launched to date of ARCALYST for recurrent pericarditis in Q3 -- or I should say, at the end of Q3, we had around 5,450 total prescribers. Now that's an uplift of around 450 quarter-on-quarter. So again, really showing very strong growth. And now we have around 30% of that group who are repeat prescribers, which is up by around 170 prescribers. Historically, we've said that the split between the first and second recurrence is about 80% of prescriptions in the second plus recurrence and 20% in the first, but we haven't updated that data on a very frequent basis as a lot of it comes from kind of ad hoc market research that we do. But clearly, we're showing pretty strong growth in Q3. And a lot of that is down to the refined targeting that we have with our field team, the DTC campaign in a very targeted approach and also just broader dissemination of the ACC concise clinical guidance and really just empowering physicians on this new way of treating the disease.

Operator

And our next question comes from the line of Geoff Meacham from Citi.

Geoffrey Meacham

Great job on the quarter. Just have a couple of quick ones. The first on 387, I know convenience angle, obviously, is a big differentiator. But beyond that, is there a patient maybe on ARCALYST today that you think is particularly suited to transition to 387 just on convenience, I know clinically, maybe those that live further away or what are the attributes of the patients, I guess, is the question that would maybe more rapidly switch?

And then bigger picture question, just on the cash and the capital deployment. You guys have been consistently profitable. You're building some cash on the balance sheet. I don't know, just trying to think of ways to maximize value from a balance sheet cash flow context? Like what are you thinking about from a BD perspective? Where does this fall in your priorities?

John Paolini

Thank you, Geoff, for your question. I'll tackle this first part with regard to the transition, if you will, from ARCALYST to KPL-387. I mean I think that our position with regard to the management of the disease is that blockade of IL-1 alpha and IL-1 beta is critical to maintaining disease control and to gaining the disease control as a monotherapy. And so in that sense, we're particularly excited about the KPL-387 program because it adds to the optionality of what's available to patients and physicians in terms of treating this disease. And so that efficacy ultimately remains to be demonstrated in the Phase III pivotal trial, which is ongoing. But importantly, what we have going on as well is the 212 study or the KPL-387 transition to monotherapy dosing and administration study, which is really designed to look at the mechanics of how to transition from one existing therapy to KPL-387 monotherapy, the 300-milligram monthly dose level. And so that includes NSAIDs and colchicine, corticosteroids or IL-1 pathway inhibitors, including anakinra and rilonacept. And all of those different transition regimens are studied and are evaluated in the study and then go on to over a 16-week primary endpoint period. So it's really about that transition. And that then informs the label with regard to telling or informing physicians how they can make that transition. But in terms of the patient profile, it's really about the optionality for the patient and the physician to choose which therapy, which effective therapy is considered to be best for them.

Sanj Patel

And Geoff, in regards to your question on maximizing the value and cash position. I mean I can tell you what drives us each and every day is the potential to increase that overall maximum value. There's so much kinetic energy within the company that's focused on that. We've talked about, obviously, today, the growth with ARCALYST, and we continue to be very excited about the future potential there. We talked about the latest penetration rate being in some ways only 23%. But equally, obviously, across the development portfolio with KPL-387 and 1161 as we've talked about, we're moving now into obviously the Phase III pivotal study for 387, being very excited about being in the clinic with 1161 later this year.

But as you see, those latter 2 programs were homegrown. We continue to look at other additional value-creating opportunities, both internally but also externally. I think we've been very judicious and very thoughtful about capital allocation. We do look at BD opportunities. But as you can imagine, with our commercial products, with our pipeline, the bar is exceedingly high. That said, we are very pragmatic bunch, and we do look at where the value could come from all the time. It's what drives us essentially. So rest assured, we know how to capital allocate. We know it best to drive value, and we'll continue doing that and ultimately keep executing.

Operator

This does conclude the question-and-answer session of today's program. I'd like to hand the program back to Sanj K. Patel, CEO, for any further remarks.

Sanj Patel

Thank you very much. Thanks, everybody, for dialing in today. Clearly, a lot of excitement, ongoing execution and very excited about the future. The team and I will keep driving for future success for patients and for creating additional value. Thank you.

Operator

Thank you, ladies and gentlemen, for your participation in today's conference. This does conclude the program. You may now disconnect. Good day.