キニクサ・ファーマシューティカルズ（KNSA）2026年第3四半期決算説明会：ARCALYSTのガイダンスを上方修正

キニクサ・ファーマシューティカルズ（NASDAQ: KNSA）は、2026年第3四半期における「ARCALYST」の成長継続を発表し、通期の売上高ガイダンスを引き上げました。また、経営陣は主要な第III相臨床試験（KPL-387）のデータ公表時期を2027年後半に設定しました。

主なポイント

• ARCALYSTの売上高は、患者および医師による採用拡大に支えられ、前年同期比58%増の2億8,600万ドルとなりました。
• キニクサは、2026年のARCALYST売上高ガイダンスを10億4,500万ドル〜10億5,000万ドルに上方修正しました。
• 営業利益は5,420万ドル、純利益は4,730万ドルに達しました。当四半期中に約4,300万ドルの純キャッシュを生み出しました。
• 複数回の再発を伴う年間1万4,000人の患者集団におけるARCALYSTの浸透率は23%に達し、2025年末の18%から拡大しました。
• キニクサは、KPL-387の主要な第III相試験データを2027年後半に見込んでおり、臨床および規制上の進展次第で、2028年〜2029年の期間での上市を目指しています。
• 同社は、年4回（3カ月に1回）投与の可能性を持つIL-1 α/β阻害薬「KPL-1161」の第I相試験を、2026年末までに開始する予定です。

主要財務データ

営業費用は、ARCALYST売上高に連動した売上原価および共同事業費用の増加、KPL-387の研究開発費の追加、商業化を支援する販売費及び一般管理費（SG&A）投資の拡大により増加しました。

事業・業績の動向

ARCALYSTは引き続きキニクサの主要な成長ドライバーでした。23%の浸透率は、年に2回以上の再発を経験する年間約1万4,000人の患者層に適用されます。経営陣はまた、初回再発を経験する年間約2万6,000人の追加患者層も特定しました。

処方医基盤は第3四半期末時点で約5,450人に達し、前四半期から約450人増加しました。約30%がリピート処方医であり、同グループは当四半期中に約170人拡大しました。同社の過去の市場調査によると、処方の約80%は複数回再発患者、20%は初回再発患者によるものです。

経営陣によると、医師らはNSAIDやコルヒチン投与後かつ副腎皮質ステロイド投与前など、病状のより早い段階でARCALYSTを検討する傾向が強まっています。調査に応じた医師の約50%がこのアプローチを支持しており、これは2025年の米心臓病学会（ACC）による簡潔な臨床ガイドライン公表前に記録された過去3年間の水準の2倍にあたります。

キニクサは、AIと機械学習を活用して医師および患者のターゲティングを精緻化しています。同社の消費者向け（DTC）「Heart’s Home」キャンペーンにより、ARCALYSTウェブサイトへのトラフィックはキャンペーン前と比較して12倍に、エンゲージメントセッションは8倍に増加しました。広告を見た患者の約55%が、医療従事者にARCALYSTについて相談する意欲が湧いたと強く同意しました。

KPL-387の主要な第III相試験は、グローバルな治験施設ネットワークを通じて患者の登録と投与を継続しています。KPL-387は、再発性心膜炎に対する月1回300ミリグラム皮下投与療法として開発が進められています。

別の単剤療法への移行試験では、患者がNSAID、コルヒチン、ステロイド、またはIL-1経路阻害薬からKPL-387へどのように移行するかを評価しています。この試験には16週間の主要評価項目期間が含まれており、用法・用量に関する文言の策定に役立てることを目的としています。

経営陣はターゲット・プロダクト・プロフィール（TPP）調査を引用し、患者の約75%が既存の製品や他の治験薬よりも、月1回投与が期待されるKPL-387の液剤処方を好むと回答したことを明らかにしました。また、調査対象となった医療従事者の92%が、そのターゲットプロフィールを処方する可能性が高いと回答しました。なお、これらの結果は臨床結果ではなく市場調査を反映したものです。

業績見通し（ガイダンス）

経営陣は、KPL-387の第III相データを2027年後半に見込んでおり、2028年〜2029年の商業化上市の可能性を見込んでいます。キニクサはまた、KPL-1161が2026年末までに第I相試験に移行すると予想しています。

リスクと注視事項

• 進行中の主要な第III相試験において、KPL-387の有効性は引き続き実証される必要があります。開発タイムラインおよび2028年〜2029年の上市見通しは、現時点では経営陣の予想にとどまります。
• KPL-387の商業的可能性は、主要試験および移行試験の結果を含むデータ次第です。
• ARCALYSTのさらなる浸透には、地理的に分散した再発性心膜炎患者層へのアプローチと、医師向け教育、現場での実行力向上、ターゲットを絞った消費者向けアウトリーチへの継続的投資が必要です。
• キニクサがパイプラインを推進し、ARCALYSTの商業化を拡大するにつれて、研究開発費および販売費・一般管理費は増加しています。

アナリスト質疑応答の主なハイライト

• KPL-387のタイムライン：経営陣は、順調な治験参加登録、患者への投与、グローバルな治験施設ネットワーク、および治験責任医師との直接的な連携を根拠に、2027年後半のデータ公表目標に対する自信を示しました。
• ARCALYSTの浸透率：経営陣は、患者属性や重症度に重大な変化は見られないと述べました。残された成長機会には、複数回再発している患者と初回再発の患者の両方が含まれます。
• 商業化投資：同社は、DTCおよびフィールド投資について、広範なものではなく標的を絞ったものであり、再発性心膜炎の可能性が高い患者および関連する医療従事者に支出を集中させていると説明しました。
• KPL-387切り替え戦略：移行試験は、経口薬、ステロイド、または他のIL-1阻害薬から月1回投与のKPL-387単剤療法へと患者を移行させるための実践的なガイドラインを医師に提供することを目的としています。
• KPL-1161：経営陣は、年4回（3カ月に1回）投与となり得るプロファイルが慢性疾患または生涯にわたる治療環境に適している可能性があると述べる一方、当面の焦点は第I相試験の開始にあるとしました。
• 資本配分：キニクサは社内外の事業開発機会の評価を続けていますが、経営陣は既存の商業ビジネスとパイプラインが取引を行う上での高いハードルを設定していると述べました。

決算説明会トランスクリプト全文

決算説明会の完全なトランスクリプト

経営陣による説明

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.

質疑応答

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.