키닉사 파마슈티컬스(KNSA) 2026년 3분기 실적 발표 콜: 아르칼리스트 가이던스 상향

키닉사 파마슈티컬스(Kiniksa Pharmaceuticals, NASDAQ: KNSA)는 2026년 3분기 아르칼리스트(ARCALYST)의 지속적인 성장을 기록하고 연간 매출 가이던스를 상향 조정했습니다. 경영진은 또한 핵심 임상 3상 연구인 KPL-387의 데이터 발표 시점을 2027년 하반기로 설정했습니다.

핵심 요약

• 아르칼리스트 매출은 환자 및 의료진의 채택 확대에 힘입어 전년 동기 대비 58% 증가한 2억 8,600만 달러를 기록했습니다.
• 키닉사는 2026년 아르칼리스트 매출 가이던스를 10억 4,500만 달러~10억 5,000만 달러로 상향 조정했습니다.
• 영업이익은 5,420만 달러, 순이익은 4,730만 달러를 기록했습니다. 당분기 동안 약 4,300만 달러의 순현금을 창출했습니다.
• 아르칼리스트의 침투율은 2025년 말 18%에서 다발성 재발 환자 연간 대상군 14,000명의 23%에 도달했습니다.
• 키닉사는 KPL-387의 핵심 임상 3상 데이터를 2027년 하반기로 예상하며, 임상 및 규제 진행 상황에 따라 2028~2029년경 상업적 출시를 목표로 하고 있습니다.
• 회사는 분기 1회 투여 가능성이 있는 IL-1 알파 및 베타 억제제 후보물질인 KPL-1161의 임상 1상 시험을 2026년 말까지 시작할 것으로 예상합니다.

주요 재무 데이터

영업비용은 아르칼리스트 매출에 연동된 매출원가 및 협력 비용 증가, KPL-387의 추가 연구개발(R&D) 지출, 상업화를 지원하는 판매관리비 투자 확대 등으로 인해 증가했습니다.

사업 및 영업 성과

아르칼리스트는 키닉사의 핵심 성장 동력 지위를 유지했습니다. 23%의 침투율은 연간 2회 이상 재발을 겪는 약 14,000명의 환자군에 적용됩니다. 경영진은 또한 첫 재발을 겪는 연간 약 26,000명의 추가 환자군을 확인했습니다.

처방 의료진 수는 3분기 말 기준 약 5,450명으로 전분기 대비 약 450명 증가했습니다. 이 중 약 30%가 재처방 의료진이었으며, 해당 집단은 분기 동안 약 170명 늘어났습니다. 회사의 과거 시장 조사에 따르면 처방의 약 80%는 다발성 재발 환자에서, 20%는 첫 재발 환자에서 발생했습니다.

경영진은 의료진이 비스테로이드성 소염진통제(NSAID) 및 콜히친 사용 후, 코르티코스테로이드 투여 전 단계 등 질환 진행 초기 단계에서 아르칼리스트 처방을 고려하는 경향이 늘고 있다고 설명했습니다. 설문 조사 대상 의사의 약 50%가 이러한 접근 방식을 지지했으며, 이는 2025년 미국심장학회(ACC) 요약 임상 가이드라인이 출판되기 전 3개년 동안 기록된 수준의 2배에 달합니다.

키닉사는 의사 및 환자 타겟팅을 정교화하기 위해 AI와 머신러닝을 활용하고 있습니다. '하츠 홈(Heart’s Home)' 소비자 직접 전달(DTC) 캠페인으로 아르칼리스트 웹사이트 방문 트래픽이 캠페인 전 대비 12배 증가했고, 참여 세션은 8배 늘어났습니다. 광고를 본 환자의 약 55%는 담당 의료진과 아르칼리스트 상담을 진행할 동기를 받게 되었다고 강하게 동의했습니다.

KPL-387의 핵심 임상 3상 연구는 글로벌 임상 기관 네트워크를 통해 환자 등록 및 투약을 계속 진행 중입니다. KPL-387은 재발성 심낭염 치료를 위한 월 1회 300mg 용량의 피하주사 제형으로 개발되고 있습니다.

별도의 단일요법 전환 연구에서는 환자가 NSAID, 콜히친, 코르티코스테로이드 또는 IL-1 경로 억제제에서 KPL-387로 전환하는 과정을 평가하고 있습니다. 이 연구는 16주의 1차 평가변수 기간을 포함하며, 용법 및 용량 문언을 확립하는 데 기여할 목적을 갖고 있습니다.

경영진은 목표 제품 프로필(TPP) 조사 결과를 인용하며, 환자의 약 75%가 기존 상용 치료제나 기타 임상 단계 치료제보다 KPL-387의 월 1회 액상 제형 가능성을 선호했다고 밝혔습니다. 이와 별도로 설문에 응한 보건의료 전문가의 92%가 해당 목표 프로필 제품의 처방 가능성이 높다고 응답했습니다. 이러한 결과는 임상 결과가 아닌 시장 조사 결과를 반영합니다.

경영진 가이던스

경영진은 KPL-387의 임상 3상 데이터가 2027년 하반기에 나올 것으로 예상하며, 2028~2029년에 상업적 출시 가능성을 보고 있습니다. 키닉사는 또한 KPL-1161이 2026년 말까지 임상 1상 시험에 진입할 것으로 예상합니다.

리스크 및 주시 사항

• KPL-387의 유효성은 진행 중인 핵심 임상 3상 시험에서 증명되어야 할 과제로 남아 있습니다. 개발 일정과 2028~2029년 출시 가능성은 경영진의 예상에 기반하고 있습니다.
• KPL-387의 상업적 잠재력은 핵심 연구 및 전환 연구 결과를 포함한 데이터에 의존적입니다.
• 아르칼리스트의 추가적인 침투율 확대는 지리적으로 분산된 재발성 심낭염 환자군에 대한 접근과 의료진 교육, 현장 실행력, 맞춤형 소비자 홍보에 대한 지속적인 투자를 필요로 합니다.
• 키닉사가 파이프라인을 전진시키고 아르칼리스트 상업화를 확대함에 따라 R&D 및 판매관리비 지출이 증가하고 있습니다.

애널리스트 Q&A 주요 내용

• KPL-387 일정: 경영진은 활발한 환자 등록 및 투약, 글로벌 임상 기관 네트워크, 연구자들과의 직접적인 소통을 바탕으로 2027년 하반기 데이터 목표 달성에 대한 자신감을 나타냈습니다.
• 아르칼리스트 침투율: 경영진은 환자 인구통계나 질환 중증도에서 유의미한 변화가 관찰되지 않았다고 밝혔습니다. 잔여 시장 기회에는 다발성 재발 환자와 첫 재발을 겪는 환자 모두가 포함됩니다.
• 상업화 지출: 회사는 DTC 및 현장 투자가 광범위하기보다는 타깃에 집중된 방식이며, 지출은 재발성 심낭염 환자 가능성이 높은 대상 및 관련 보건의료 전문가에게 집중되고 있다고 설명했습니다.
• KPL-387 전환 전략: 전환 연구는 의료진에게 경구용 치료제, 코르티코스테로이드 또는 기타 IL-1 억제제에서 월 1회 KPL-387 단일요법으로 환자를 전환하기 위한 실용적인 지침을 제공하는 것을 목적으로 합니다.
• KPL-1161: 경영진은 임상 1상 시험 시작에 당장의 초점을 두고 있지만, 분기 1회 투여 가능 프로필은 만성 또는 평생 질환 치료 환경을 지원할 수 있다고 밝혔습니다.
• 자본 배분: 키닉사는 자체 및 외부 사업 개발 기회를 계속 평가하고 있지만, 경영진은 기존 상업 사업과 파이프라인으로 인해 거래 성사에 대한 기준을 높게 설정하고 있다고 밝혔습니다.

실적 발표 콘퍼런스 콜 전문

전체 실적 발표 컨퍼런스 콜 녹취록

경영진 발표

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.

질의응답

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.