ベータ・バイオニクス（BBNX）2026年第3四半期決算説明会：Mintのローンチと売上高見通しの引き上げ

Beta Bionics（BBNX）は、薬局でのリピート収入と新規患者の導入が成長を支え、2026年第3四半期の売上高が過去最高を記録したと発表しました。また同社は、FDA（米食品医薬品局）の承認を取得したパッチポンプ「Mint」の2027年第1四半期における全米発売計画の詳細を明らかにするとともに、「3D Intelligence」に影響している規制当局の審査遅延について説明しました。

主要なポイント

• 第3四半期の売上高は過去最高の3,550万ドルに達し、前年同期比約30%増となりました。新規患者の導入と、拡大する薬局顧客基盤からのリピート収入が牽引しました。
• 粗利益率は57.3%となり、前年同期比で179ベーシスポイント上昇したものの、不調なDME製品ミックスと販売代理店の在庫調整パターンにより前四半期比では178ベーシスポイント低下しました。
• Beta Bionicsは2026年の売上高見通しの下限を1億2,100万〜1億2,600万ドルから1億2,400万〜1億2,600万ドルに引き上げました。
• FDA承認済みのMintパッチポンプは、引き続き2027年第1四半期に全米での完全な商業化が予定されています。経営陣は2027年を通じて生産を拡大し、年間で少なくとも150万台に達すると見込んでいます。
• 同社はFDAの要請を受け、3D Intelligenceの510(k)申請を取り下げており、2026年第4四半期半ばに再申請する予定です。経営陣によると、残された質問はアルゴリズムやその結果ではなく、シミュレータの検証に関するものであるとのことです。
• 2026年9月30日時点の現金、現金同等物、および短期・長期投資の合計は約3億7,400万ドルとなりました。これは、約1億6,100万ドルの純手取額をもたらした公募増資によるものです。

主要財務データ

営業費用の増加は、営業組織の拡大、マーケティング投資、およびMintや2種ホルモンプログラムに関する研究開発費の増加を反映しています。一般管理費も、事業規模の拡大とプロダクトパイプラインの進展に伴い増加しました。

事業および業績の動向

Mintの発売と生産拡大

Beta Bionicsは9月にMintのFDA承認を取得し、2027年第1四半期に全米での全面的な商業展開を予定しています。このパッチポンプは充電が不要で、持続血糖測定器（CGM）と連携し、iOSおよびAndroidのスマートフォンから操作可能です。

Mintは3D Intelligenceの承認がなくても発売可能です。2027年の生産計画について、経営陣は年間少なくとも150万台に向けた、概ね直線的な生産能力の拡大を想定するよう提示しました。初期製造ラインは稼働準備が整いつつあり、同社は4交代制によるほぼ連続した生産体制を維持するための人員採用を進めています。

経営陣は、Mintの保険適用率が発売時点で米国の被保険者の約40%に達し、2027年末までに約50%へ拡大すると見込んでいます。需要が生産能力を上回った場合、Beta BionicsはiLetからの乗り換えユーザーよりも新規ユーザーを優先する方針です。

Mintは2027年の粗利益率を押し下げる要因となると見込まれています。しかし経営陣は、その製品構造により、3年以内に既存のパッチポンプ競合大手を上回る粗利益率を実現できる可能性があると述べています。この設計は、2年間の使用が見込まれる耐久性コンポーネントと、使い捨てのMintコンポーネントを分離した構造になっています。

iLetの成長と定着率

売上高の成長は引き続き、新規患者の獲得と薬局顧客基盤からの消耗品のリピート販売によってもたらされました。新規患者の約69%は以前に1日複数回注射（MDI）療法を行っていた患者であり、iLetがインスリンポンプをまだ使用していないユーザーを引き続き引き付けていることを示しています。

経営陣は患者の定着率を堅調と説明し、2型糖尿病患者の定着率は1型糖尿病患者をわずかに上回っているものの、大きな差はないとしています。

第3四半期の粗利益率の低下は、患者需要の減退ではなく、DME（在宅医療機器）販売代理店の在庫変動を反映したものです。代理店がBeta Bionicsから仕入れた数量以上に患者へiLet製品を供給したため、代理店在庫が減少しました。同時に、利益率の低いインフュージョンセットやカートリッジの在庫比率が高まったことで、不調な売上構成（プロダクトミックス）が生じました。

プロダクトパイプライン

Beta Bionicsは2026年第4四半期半ばに3D Intelligenceの510(k)申請を再提出する計画です。経営陣はFDAの承認を前提として、2027年半ば頃にiLet 3DおよびMint 3Dの全米発売を見込んでいますが、FDAが再申請を前回の審査の継続として扱う場合、より早い承認の可能性もあると付言しています。

2型糖尿病の成人患者を対象としたリアルワールドでの枢要試験（ピボタル試験）の治験参加者登録が完了しました。同社はFDAの承認を前提として、2027年半ば頃に米国での適応追加と商用発売を目指しています。

Beta Bionicsはまた、今後数週間以内に次世代完全クローズドループ・アルゴリズムの米国枢要試験を開始する予定です。このシステムは食事の事前入力を不要にするよう設計されており、1型および2型糖尿病の成人患者を対象に検証が行われます。

iLetとSenseonicsのEversense 365との連携機能は、2026年第4四半期に開始される予定です。同社は将来的にMintとEversense 365の連携も計画しています。2種ホルモンシステムについて、経営陣は薬剤の再製剤化が完了し、追加の第IIa相臨床試験の準備が進んでいると述べました。

経営陣の見通し（ガイダンス）

経営陣は、第4四半期の新規患者導入数が第3四半期から前四半期比で約20%減少すると予想しています。また同社は、2026年にMint待機によって繰り延べられたiLetの需要は2027年に十分に回復すると見込んでいますが、2027年通期の公式な売上高見通しは公表していません。

リスクおよび注視事項

• 3D Intelligenceの規制当局による承認時期：90日間の審査期間終了時点で質問事項が残っていたため、FDAから申請の取り下げと再申請が要請されました。承認の時期は、追加のシミュレータ検証作業の完了とFDAの審査プロセスに依存します。
• Mint発売の実行力：2027年の生産拡大は、製造ラインの検証、人員配置、歩留まり、稼働率、サイクルタイム、および追加生産ラインの水平展開に左右されます。
• 保険の適用範囲：経営陣は2027年中にMintの保険適用が拡大すると予想していますが、薬局チャネルでの保険が適用されないユーザーは、iLetを選択するか、導入を見送るか、あるいは他の選択肢を選ぶ可能性があります。
• 短期的粗利益率へのプレッシャー：Mintは2027年の粗利益率を希薄化させると見込まれるほか、四半期ごとのDMEの発注量や製品ミックスの変動が引き続き報告上の利益率に影響を与える可能性があります。
• 需要の繰り延べ：iLetの導入を検討している一部のユーザーがMintの発売を待つ可能性があります。経営陣は現在、2026年第4四半期の見込み売上繰り延べ額を最大850万ドルと見積もっています。
• 2型糖尿病および完全クローズドループ・プログラム：商業展開の時期は、試験結果やFDAの承認に引き続き左右されます。同社は完全クローズドループ・アルゴリズムの承認スケジュールを明らかにしていません。

アナリスト質疑応答の要点

• 3D Intelligenceの申請取り下げ：経営陣によると、FDAからの質問は、3つのアルゴリズムモード、臨床結果、ヒューマンエラー要因、あるいはアルゴリズムそのものではなく、Beta Bionicsがどのようにシミュレータを検証したかに焦点を当てたものでした。再申請では、追加の検証作業を行った上で同じアルゴリズムが使用されます。
• Mintに対する需要：iLetの購入繰り延べが予想を下回った理由について、経営陣は関心の低さではなく、消費者におけるMintの認知度がまだ限られているためと説明しました。同社は、調査対象となったiLetユーザーの間でMintに対する強い選好が示された社内調査を引き合いに出しました。
• Mintの保険償還：同社は、パッチポンプとしての製品分類や、主要な薬剤給付管理会社（PBM）および医療保険プランとの既存の関係により、発売時点からの保険適用がサポートされると見込んでいます。
• 既存iLetユーザーの移行：一部のiLetユーザーがMintへ移行すると予想されていますが、初期供給が制限された場合、経営陣は新規のBeta Bionicsユーザーを優先する計画です。なお、患者1人あたりのMintの保険償還額は、iLetユーザーからの毎月のDME消耗品収入よりも大幅に高くなる可能性があると言及しました。
• 完全クローズドループの位置付け：経営陣は、食事の事前入力を不要にすることで、トレーニングを簡素化し、特にプライマリ・ケア分野での自動インスリン投与へのアクセスを拡大できると考えています。また、このアプローチが集団レベルで低血糖を増加させるとは予想していません。

決算説明会トランスクリプト全文

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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

Good afternoon, and welcome to the Beta Bionics Third Quarter 2026 Earnings Conference Call. [Operator Instructions] As a reminder, please be advised that today's conference is being recorded.

And now I'd like to hand the conference over to Blake Beber, Head of Investor Relations. Please go ahead, sir.

Blake Beber

Good afternoon, and thank you for joining Beta Bionics third quarter 2026 earnings call. With me on today's call are Chief Executive Officer, Sean Saint, and Chief Financial Officer, Stephen Feider. Both the replay of this call and the press release discussing our third quarter 2026 results will be available on the Investor Relations section of our website.

Information recorded on this call speaks only as of today, October 27, 2026. If you are listening to a replay of this call, any time-sensitive information may no longer be accurate.

Also on our website is our supplemental third quarter 2026 earnings presentation and updated corporate presentation. We encourage you to refer to those documents for a summary of key metrics and business updates.

Before we begin, we'd like to remind you that today's discussion will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements reflect management's expectations about future events, our product pipeline, development time lines, financial performance and operating plans, and speak only as of today's date. Please refer to the cautionary statements in the press release we issued earlier today for a detailed explanation of the inherent limitations of such forward-looking statements. These documents contain and identify important factors that may cause actual results to differ materially from current expectations expressed or implied by our forward-looking statements. We undertake no obligation to update them to reflect subsequent events or circumstances except to the extent required by law.

With that, I'd now like to hand the call over to Sean.

Sean Saint

Thanks, Blake, and thanks everyone for joining. Q3 is usually a somewhat boring quarter in diabetes, with summer vacations and a lull of news after ADA. Today, we're going to do our best to spice it up a little bit with some great updates. So let's dive in. In September, we received FDA clearance for Mint, our transformative patch pump, which we expect to fully commercialize in the U.S. in Q1 of 2027. I feel this will ultimately prove to be the largest milestone achieved by the company to this point, and what an incredible effort it has been from the team to get that product designed, developed, and cleared by the FDA in a matter of about 3 years, which we believe is the fastest ever time line from concept to clearance for an automated insulin delivery or AID patch pump.

We believe that Mint will be a game changer for people with diabetes. Starting in Q1 of next year, the only fully adaptive and most advanced insulin dosing algorithm in the U.S. can power the smallest AID patch in the U.S., a patch pump that never requires recharging, integrates with industry-leading continuous glucose monitors, and can be controlled by iOS and Android smartphones. We designed Mint around the user experience, and the feedback we've gathered across our development program keeps reinforcing that. One recent example is from a survey of 30 active users of a competitive patch pump. All 30 rated Mint insertion as less painful. Delivering life-changing solutions that simplify and alleviate the burden of managing diabetes is critical. We strongly believe that Mint will deliver on that promise.

In September, we completed a public offering, raising approximately $161 million in net proceeds. This capital strengthens our balance sheet and provides flexibility to support the commercialization of Mint, invest in our operations, and pursue future growth opportunities.

Moving now to a brief overview of our Q3 performance. We delivered a record quarter of $35.5 million in net sales, which grew approximately 30% year-over-year. Q3 revenue growth was driven by growth in new patient starts and our growing installed base of users in the pharmacy channel, who we continue to retain at a high level. The percentage of new patient starts that were reimbursed through the pharmacy channel was in the high 30s. Our gross margin was over 57%, expanding 179 basis points year-over-year. Later, I'll give more detail around our new algorithm, 3D Intelligence, and other projects in our innovation pipeline.

But first, I'll hand the call over to Stephen to provide some additional detail on our third quarter performance and our updated full year 2026 guidance. Stephen?

Stephen Feider

Thanks, Sean. Our revenue performance was mainly driven by new patient starts and the recurring revenue generated from our growing pharmacy installed base. New patient starts increased a mid-single-digit percentage compared to the prior quarter, consistent with our expectations. We continued to expand the insulin pump market as approximately 69% of our new patient starts came from people utilizing multiple daily injections prior to starting on iLet. A high 30s percentage of our new patients access iLet through the pharmacy channel, consistent with our expectations.

Moving on to gross margin. Q3 gross margin was 57.3%, down 178 basis points quarter-over-quarter, and up 179 basis points year-over-year. Gross margin was below our expectations, primarily reflecting a lower contribution from higher margin DME iLet revenue due to distributor stocking dynamics. DME iLet sales, a high-margin revenue source, declined quarter-over-quarter, even as DME new patient starts increased. Distributors supplied more iLets to patients than they purchased from Beta Bionics, which means the DME distributors ended Q3 with lower iLet inventory than at the end of Q2. This reflects normal variability in distributor ordering rather than weaker patient demand. At the same time, increased distributor stocking of lower margin DME supplies, meaning infusion sets and cartridges, largely offset the revenue impact from DME iLets, but created an unfavorable mix for gross margin. We expect revenue mix to normalize in Q4 and are maintaining our full year gross margin guidance. Meanwhile, continued growth and strong retention of our pharmacy installed base support a growing stream of high-margin recurring supply revenue.

Total operating expenses in the third quarter were $46.9 million, an increase of 46% year-over-year. The increase in sales and marketing expense compared to the prior year is driven by expansion of our field sales organization and marketing investments. The increase in R&D expenses relative to the prior year is driven predominantly by the Mint and bihormonal projects.

The increase in G&A expenses relative to the prior year is driven by continued efforts to scale the company in support of commercial growth and pipeline initiatives.

As of September 30, 2026, we had approximately $374 million in cash, cash equivalents, and short- and long-term investments. The capital raise was primarily intended to fund capital expenditures for Mint manufacturing and strengthen our balance sheet. We will continue to spend with discipline and expect to achieve positive free cash flow well ahead of historical diabetes peers.

I'd now like to discuss our updated full year 2026 guidance. We are increasing the lower end of our revenue guidance and now expect to generate total revenue of $124 million to $126 million, up from our prior guidance of $121 million to $126 million. The updated guidance reflects our expectation to generate $29 million to $31 million of revenue in the fourth quarter. Our previous guidance reflected a potential revenue deferral impact of up to $10 million in the fourth quarter as new prospective iLet users could choose to await the launch of Mint. While we are seeing some evidence of this occurring in the fourth quarter, it is not happening at the rate that we initially expected when Mint received clearance, and we now expect a potential revenue deferral impact of up to $8.5 million in the fourth quarter.

On the percentage of new patient starts reimbursed through the pharmacy channel, we are reiterating our expectation of 37% to 39% for the full year. On gross margin, we are reiterating our full year outlook of 58.5% to 59.5%. This outlook reflects our expectation that the unfavorable revenue mix in Q3 will reverse in Q4, along with continued strong retention of our pharmacy installed base and the high-margin recurring supply revenue it generates.

We expect a modest increase in operating expenses in the fourth quarter compared to the prior quarter, driven primarily by higher R&D expenses supporting our fully closed loop pivotal study, which Sean Saint will describe in more detail momentarily. We expect fourth quarter capital expenditures in the low- to mid-single-digit millions as we expand Mint manufacturing ahead of the full U.S. launch in Q1 2027.

Sean, back to you.

Sean Saint

Thanks, Stephen. I discussed our Mint update in detail earlier, and now I want to cover some other important updates in our innovation pipeline. First, 3D Intelligence, the next-generation insulin delivery algorithm we unveiled in September. It is designed to give clinicians a choice of 3 algorithm options to better match each patient's individual insulin needs while maintaining the simplicity and automation of our current algorithm. Following recent discussions with the FDA, we withdrew our 510(k) submission at the agency's request. During the review, we responded to FDA questions and requests for additional information. At the end of the 90-day review period, additional questions remained, and the agency asked us to withdraw and resubmit. While this is disappointing, we remain confident in 3D Intelligence potential. We are working to address the FDA's feedback and intend to submit the revised 510(k) in mid-Q4 2026.

For clarity, the remaining questions were just that, questions on approaches that we took. We do not believe there were any concerns with the algorithm itself, and the resubmitted 510(k) is on the exact same algorithm with no changes, but with additional validation activities completed. Our current expectation is to launch 3D Intelligence in the U.S. as iLet 3D and Mint 3D around mid-2027, subject to FDA clearance. Depending on the timing and resubmission and FDA clearance, a launch as early as the fourth quarter of 2026 remains possible. Together, these products would expand our automated insulin delivery platform, offering patients and clinicians greater choice in both algorithm options and device form factors.

Regarding our real-world pivotal trial in adults with type 2 diabetes, we have completed enrollment and expect that study will enable us to expand our algorithm's indication for use to include adults with type 2 diabetes in the U.S. around mid-year 2027, subject to regulatory clearance by the FDA. In Q3, we continued to see off-label prescribing of the iLet for people with type 2 diabetes, and we estimate greater than 30% of our new patient starts in the quarter were type 2. With the pivotal study completing enrollment, we are one step closer to potentially offering that community the means to access our algorithm on label.

Another exciting update on the algorithm front is that, in the coming weeks, we are expected to initiate a pivotal trial in the U.S. studying our next-generation fully closed loop algorithm in adults with type 1 and type 2 diabetes. Our next-generation fully closed loop algorithm in development completely removes the meal announcement feature for users and represents a potential next step forward for the entire automated insulin delivery industry, and certainly the potential to further alleviate the burden of managing diabetes in a significant way.

In the effort to maximize choice for our users wherever we can, we continue to advance our integrations with leading continuous glucose monitors. In Q4, we expect to launch our integration of iLet with Senseonics' Eversense 365 and are committed to integrating Mint with Eversense 365 in the future.

We continue to refine our bihormonal system. The drug reformulation is complete, and additional Phase IIa trials are in the works. Assuming these trials proceed as planned, we believe the program is back on track and will continue to provide updates as we progress.

We communicated a lot of updates today, and the collection of those updates go to show the foundation we've built and the steps that we're continuing to take toward building a category-leading diabetes technology company. This company is executing across the board at the highest level, and we have the team and the road map to deliver for the diabetes community.

With that, I'd like to thank you all for joining today's call, and we'll now open it up for Q&A.

Operator

[Operator Instructions] Our first question for today comes from the line of Matthew O'Brien from Piper Sandler.

質疑応答

Matthew O'Brien

I guess, Sean, maybe for starters on 3D, that's probably going to get the most attention today. Can you elaborate a little bit more on some of the additional questions that they had? Was it simplistically just validation testing they wanted you to do? Or because it's 3 different algos or 3 different options for the patient, is it more just patient-specific kind of testing, making sure they know what they're doing? Just anything more you can talk about as far as the delay there. And I do have a follow-up.

Sean Saint

Yes. Great question, Matt, thank you. It's -- your last portion of question there alluded to the fact that it may be like a human factors type thing, and that's not it at all. Primarily, for us, in this particular submission, simulation is a huge part of it, and simulation is a relatively new area for diabetes algorithms. We're all getting a lot better at it. And the FDA offers a guidance document on what they believe they want for a simulation. But, like many guidance documents, we are all still learning to interpret it perfectly. So it's around that. It's around the validation of our simulator, not the results of it, not the algorithm itself, not what we do, but just ensuring that we can trust the output of the simulator.

So again, not proposing that there is a problem, instead more proposing that we want to make sure that there is not. Hopefully that's helpful. But again, it's not a human factors thing, it's not an output thing, it's not an outcomes thing. It's none of those things. It's just ensuring we did the right work to validate our simulator.

Matthew O'Brien

And then I really don't want to make a mountain out of a molehill here, but the commentary that Stephen had on deferrals coming in lighter than expected, you can't overread that as, "Hey, you know what, we don't -- the patch is -- there's not as much interest in the patch as maybe we thought, that's why we are not seeing as much deferral." Like, "Hey, you guys are a durable pump company. We like you guys. We like your algo." Is there anything to read into that commentary?

Sean Saint

No, that's a really good question, too. I think it reflects a little bit more on an understanding of exactly how informed people are. And our fear was based on, of course, we've done market research, and we've asked our users who would prefer Mint, et cetera, and frankly, we're, I'll say, very surprised, and at some level, scared by the answers and that people love the Mint product. If everybody had perfect information, then likely we would have seen more waiting. But the reality is that, most people are not wandering through their lives wondering when Mint is coming out, right? They're just not that familiar with it. So because the awareness of the product is a little lower, the pauses were also a bit lower. But again, I don't mean that in a negative way. Like these are people who haven't seen their health care providers, and certainly their health care providers are not in the business of pushing Mint at this point. So it was -- but it was very hard for us to know who would know about it, who was following along, et cetera. And we intended to be conservative on that.

Operator

And our next question comes from the line of Lawrence Biegelsen from Wells Fargo.

Larry Biegelsen

First, I just wanted to start on Mint. When do you expect the first commercial shipments of Mint to occur? Do you need to wait for 3D to be cleared? How should we think about the ramp through '27? And I have 1 follow-up.

Sean Saint

Yes. Larry, I think we've said probably all we're prepared to say on when the first commercial shipment will be, just in the first quarter here. No, I don't think we need to wait for 3D, although the sooner we get it, the sooner we will be able to launch 3D on Mint, which is obviously a big deal for us just because we have a huge degree of confidence in each one of those products, but they are independent, so we can ship without it.

And great question on the ramp throughout the year. It's not exactly like this, but I think a good mental model is that, we start, let's just say, near 0, and we add capability throughout the year. From a modeling perspective, model it as basically linear from now through the end of the year, averaging out at what we've previously stated, which is at least 1.5 million units for the year. Is that helpful?

Larry Biegelsen

That's very helpful. And just for my follow-up, when Mint was approved, you lowered the '26 guidance by $10 million. That's obviously $8.5 million now, and you expect to recover that next year. I think consensus was about $180 million when Mint was cleared. So I just want to ask the obvious question. It sounds like you're comfortable with about $190 million in sales next year. Can you confirm that and just talk about maybe the shape of revenues next year?

Stephen Feider

Yes, reiterating what you just said, Larry, we've communicated that any deferral that we would see from prospective Mint users who would've otherwise purchased iLet in 2026, we expect to more than make up for that deferral in 2027. So your math is accurate. So now we're expecting the deferral or the benefit into 2027 from 2026 deferral for at least $8.5 million from where we currently have the consensus. Or where we had the consensus before Mint approval, I should say.

Operator

And our next question comes from the line of Chris Pasquale from Barclays.

Christopher Pasquale

I was hoping you could talk a little bit about your fully closed loop algorithm and what we might see there that differs from what other companies in the space are working on. Are you guys approaching that project differently, do you think, given your history of having a more kind of hands-off algorithm to begin with? We'd just love any comments there on how you're taking maybe a little bit of a different angle.

Sean Saint

Yes, Chris. I would say the -- we do -- okay. Let me take a moment to define a term here, which we do rarely. Hybrid closed loop, of course, means including interaction from the patient. Fully closed loop means not needing to require anything from the patient, meaning meal announcements, for example. And then there's a concept of forced fully closed loop, which is probably not a marketing term that we'll continue with, but it's descriptive. And what it means is, not being able to meal announce, right? Purely a fully closed loop system. And that's the direction we're going with this particular product. It is based on sort of a subsegment of the 3D algorithm. And importantly, it's going to be studied in both type 1 and type 2 diabetes.

Said another way, we do believe that there's a huge cross-section of people that can benefit from an algorithm like that. And part of that, by the way, is in the primary care space where it's more difficult to train on some of these things. So training becomes quite a bit easier when you're not forced to discuss, at any level, meal announcements, when the product just handles it. So I think when you compare the different development paths that different companies have followed, they're either a subsegment of users or they're maintaining a lot of the complexity of the previous device. We've tried to take a slightly different perspective, which is to include everybody, type 1 and type 2, while making this massively simpler device that can be used by anybody in any position. Said another way, we think it's the most commercially viable of the different architectures that are being studied right now.

Now with that being said, that's not for everybody. And I think what we've seen lately from Beta Bionics is, in terms of 3D, in terms of forced fully closed loop, et cetera, we have a pretty robust algorithm development team here in terms of our type 2 submission that we're talking about. And this is not our last bite at the apple.

Christopher Pasquale

That's helpful. And I was just hoping you'd comment on the type 2 trial and what we should expect from here. When could that data be available? Is that going to line up with ADA next year? Or could it come sooner when we would actually see that readout?

Stephen Feider

The first time we'll plan to communicate the data readout from the trial, again, acknowledging this is a real-world observational trial is at the time when we get the clearance, which will be simultaneous with us having the label and then in effect, commercially launching it. I can't be more specific on your time line relative to ADA other than what the public guidance that we've communicated, which is we expect this in the first half of next year.

Operator

Our next question comes from the line of Mike Kratky from Leerink Partners.

Samuil-Hrabar Gatev

This is Sam on for Mike. Maybe just turning back to the Mint adoption ramp, could you just provide some more color on the degree to which capacity is currently in place to produce the 1.5 million units you expect? Any meaningful additional commercial milestones that need to take place ahead of the launch to really hit the ground running? And then to what degree you could potentially expand beyond the capacity should outsized demand arise?

Sean Saint

Yes, all good questions. Let me start with the current capacity. As I answered earlier, I think with Larry, for modeling purposes, we should assume sort of near 0 at this stage. But the reality is not quite near 0, of course. Well, it's effectively 0 because the line is not up, validated, and ready to go. It's extremely close to that. But we will start with a baseline level of production with a single manufacturing line. I'll give 1 additional piece of color here. We're hiring for that line now, and we're, I'm not going to give an exact number, but meaningfully all the way through hiring a full 4 shifts for that line. Four shifts are what we believe are required to run the line effectively 24/7. And again, to keep that line up and operating at that level, we're near there. Opportunities for expansion beyond that, which are required throughout the year, are to replicate that line additional times. I'm not going to state how many or talk about cycle times today. And then opportunities for outperformance are primarily replicating additional lines.

And then there are all your little ankle biters that pull away from your production capacity, right? Those are yield. Those are uptime of the line. And then production capacity, meaning cycle time, which I'm not going to state, but if we can ever improve cycle time of the line, that obviously improves output of each and every line. So those are the kinds of things we'll be looking at in order to improve production capacity should it be necessary.

Samuil-Hrabar Gatev

And then I just had a quick follow-up maybe on that point. Can you just kind of provide a little bit more color on Mint's expected gross margin impact in '27? Obviously, I think you mentioned it was going to be dilutive, but just the volume milestones needed to achieve accretion and when you expect that could occur.

Stephen Feider

Perfect. Yes. So yes, Mint's gross margin will be dilutive in 2027. Where we have the analyst models currently -- the sell-side analyst models currently, we are comfortable with, and I'm not -- I won't give any specific guidance on 2027 yet, but just acknowledging again that we've communicated our expectations with sell-side analysts, and we have the models in a reasonably good place for 2027.

Over the next 3 years, and this is the exciting thing, over the next 3 years, the cost characteristics of Mint and the design decisions that we've made for Mint allow us to have within 3 years a gross margin outcome for that product that we expect to exceed our current patch pump incumbent. And again, at the scale that we're talking about at that particular time period, the reason that we have the ability to achieve that level of gross margin or that gross margin profile is because of the design decisions, meaning we have a durable component, which is where kind of the meat of the product lives, the sort of the expensive components that last 2 years. And then the disposable component, which we call Mint, that patients use whenever they're done with their 200 unit cartridge or up to 3 days-plus 12 hours. That is much, much more cost-effective to make than what we're familiar with in the patch pump world. So super exciting gross margin profile and profit outlook for Beta Bionics in that regard. And I appreciate you asking about it.

Operator

And our next question comes from the line of Michael Polark from Wolfe Research.

Michael Polark

Couple follow-ups on 3D Intelligence update. Just on timing quickly so I understand it, you're submitting more data back to FDA. It could be still possible you get that approval by the end of this year. I just want to make sure I understand that. That's only, say, 45 days. Sounds quick.

And then the bigger question was just about the validation of the simulator. Is it specific to the more aggressive or the more conservative versions of the algorithm? Or it's not about 1 of the 3 at all, it's about how you tested and framed the system? I wanted to just understand if it was about 1 nudge of the algorithm or not?

Sean Saint

Yes. Great questions, Mike. So yes, that would be quick. There's no question about it. So we did announce in the prepared remarks that we'll be resubmitting this year. We were very far through this submission, and unfortunately, we just ran out of time. So there's a possibility that the agency sort of picks up the new submission and looks at it as a continuation and picks up right where they left off. And if they were to do that, there is, I would say, even a decent possibility that we could be looking at a clearance this year. They are not, by any means, obligated to do that, and the statutory numbers absolutely put us into next year. So that I think is the most likely scenario and what we're preparing everybody for with our guidance. But if they were then to turn around and give it to us this year, I didn't want everybody to look at us and say, "Hey, what gives? You didn't tell -- you said it was Q4, then it was first half. Now it's Q4 again." Technically, that remains on the table. So we wanted to be honest about that. But again, the guidance itself is that, we're likely to see this next year.

On the second half of your question, it was -- the questions were very much specific to the simulator itself. They have nothing to do with individual modes of the algorithm. So I want to be clear. It's not that the simulator said, "Here's the output," and they said, "Ooh, that's concerning." That's not it. For any one particular mode. That's not it. What it was, "Hey, really interesting simulator guys. We're not -- you haven't provided enough data for us to believe it yet. We like what you showed us. We like the outcome, but we don't believe it yet." That's what validation of the sim itself is about. So again, the outcome of the simulator, the outcome of the modes, 3D itself, all that's good, we believe, but that's all hinged upon our simulator being believable, which is what validation of the sim is about. So no, not specific to modes, specific to the -- not even specific to the simulator, specific to the way we validated the simulator.

Operator

And our next question comes from the line of Steve Lichtman from William Blair.

Steven Lichtman

Sean, can you talk about how you see pharmacy coverage building in 2027 for Mint? I think you said you'll start at the high 30s, 40% pharmacy mix you're at today. What are your latest views on what happens with prospective customers who don't get pharmacy coverage as well? You still assuming most purchase iLet?

Sean Saint

I'm going to kick that one to Stephen, actually.

Stephen Feider

Steve, pharmacy coverage expectations for 2027 for Mint are at the time of launch, we expect roughly 40% of all lives in the country to be covered for Mint, growing to around 50% by the end of the year. So that's just the crisp way of communicating what expectation we have.

Steven Lichtman

And for those that don't have pharmacy coverage and therefore won't be able to get Mint, you're still assuming most will purchase iLet? Or what are your latest thoughts on that?

Stephen Feider

Well, there's a few different permutations of this, all of which will likely happen. Certainly, people who would prefer Mint, who don't have insurance coverage for Mint, in some cases are going to buy iLet. I would actually use a data point that we even have internally today to kind of prove that our particular value proposition of iLet will continue to win with many patients who would prefer to wear a tubeless pump. We actually surveyed several hundred or, a little over 300 of our users and asked them a question of, "If knowing what you know about Mint and assuming no difference in your out-of-pocket cost each month, would you prefer to switch to Mint right now?" And almost 90% of those patients said yes.

Now, that's a relatively small sample, but I think it proves that what we're selling, meaning the iLet's differentiation of a fully automated system, will continue to win even up against other patch pump form factors. So I think that people will certainly fall into the category of, okay, I'm not covered for Mint, and I suppose I would prefer to be on a Beta Bionics product, and if I could choose, I'd prefer Mint, but I'm still going to purchase iLet. There will certainly be some of those people.

Now will there be some deferrals of patients who will otherwise wait to get Mint before they start on iLet? Absolutely. And quantifying that right now is a little bit difficult, candidly. We've had FDA clearance for our product for 5, 6 weeks, and we have sort of good experience in understanding what the patient demand is like for iLet, in spite of there being Mint clearance. But I think that that will be different, of course, when we actually launch it commercially rather than it just existing as a future product.

So sorry to not give you a precise mathematical answer on that. I have a hard time, not doing that as a finance guy, but I don't exactly know how each of those categories will get bucketed.

Steven Lichtman

Stephen, and just quickly, any update on the fully automated manufacturing time line?

Sean Saint

Probably no update on the time lines for that. I suppose I'll say that, as we've discussed in the past that we have a line up and operating. We have additional lines being constructed at this time, and we are working at this stage on our more fully automated manufacturing lines for the future. I think we've probably said in the past that was a future item. We are thinking about that now and doing the actual work now. But I'm not going to provide exact time lines on it.

Operator

And our next question comes from the line of Jeffrey Cohen from Ladenburg Thalmann.

Jeffrey Cohen

So just 2 brief ones. So I missed it, Stephen. Q3 pharmacy composition was what percent that you called out earlier in the call?

Stephen Feider

A high 30s percentage of our new patient starts went through pharmacy in the third quarter.

Jeffrey Cohen

And then, I guess, when it comes to the Mint line, the $4 million to $6 million CapEx that you called out, was that specific to 1 line? And the anticipation, it sounded like that would be somewhat linear as Mint rolls out and rolls up as opposed to a step function. Any further color on that?

Stephen Feider

Yes. The low to mid-single-digit CapEx that we'll have in Q4, and then much of the CapEx that we'll spend in 2027 is associated with our automated or semi-automated manufacturing line. And that's actually more than one line. When I say line, I mean, it's our semi-automated and manual manufacturing operation. So those -- yes, it's not one individual line. Now there's a separate project that Sean just kind of alluded to a moment ago of making the manufacturing for Mint more fully automated, and that has its own CapEx profile that I can get into if you'd like, but that's more in future years, although we'll start to see some of that CapEx incurred in '27. But yes, I think that answers your question.

Jeffrey Cohen

Okay. Most of this commentary is related to Mint, not specific to iLet when you're talking about CapEx and automation.

Stephen Feider

That's right. Yes. The CapEx for iLet manufacturing is behind us.

Operator

Our next question comes from the line of Jeff Johnson from RW Baird.

Jeffrey Johnson

Maybe 2 algo questions if I could, Sean. One, just on type 2, if you're using real-world data there and you won't have the 3D algos out until later this year or probably early next year, will you get type 2 on 3D or how are you going to restrict use to just the standard iLet algo in the type 2 adult patients that you're targeting for mid-year approval there? Just the mechanics of how that type 2 approval will come across from an algo perspective.

Sean Saint

Yes, that's a really good question, Jeff. And frankly, we're not exactly sure yet. So as you've alluded to, our real-world evidence study obviously studies people -- type 2 users using the current algorithm as it sits today. That is one of the modes available in 3D because we know and love it, and users know it and love it. So at a minimum, we would expect that we can get type 2 indication for that mode of the algorithm. But remember that we're also getting 3D, well, we hope to be getting 3D cleared through primarily through simulation data, and assuming that that's the case, we may be able to apply the same level of thought to get this in a wider, fully, on all of 3D, if you will. But to be 100% honest with you, we're not sure yet. This is going to be a conversation that we have to have with the agency once we get into it.

Stephen Feider

Yes. One thing I need to add here. I was answering a type 2 question earlier that Chris Pasquale asked, and I just fact-checked myself looking at my notes. I had communicated in the response to the question that the type 2 indication was a first half time line. And since we're calling that a mid-2027 indication and commercial launch for type 2, not a first half time line. So [indiscernible] for the second part of your question.

Jeffrey Johnson

Yes. Just the second question is just on the forced FCL decision. I'm a little surprised you're doing that on the T1 side, I guess. I mean, Sean, you know more than any of us the alpha response there issues and concerns that if you cannot interact with your pump at all, does that increase in T1 at least the risk of hypo in a fully closed loop or a forced fully closed loop? I guess my question is, what is going to be your bar on what is acceptable from an increase in hypo risk from baseline to forced FCL or just any other thoughts you can give us on doing the forced FCL pathway in T1?

Sean Saint

Yes. So the first is, I do not think that forced FCL should result in a higher level of hypos. As with anything, diabetes is a tough beast. There are always going to be individual users that have 1 experience or another. But I don't think, as a general statement, forced FCL should be a higher level of hypo. In fact, I think it should probably be lower.

But additionally to that, there is unquestionably an enormous group of type 1s today that aren't getting access to AID generally, that absolutely has lower risks of hypo than MDI. That absolutely has lower risk of hypos than what you might call standard of care. And we need to make sure that they have access to that. And by providing a simpler system that's both simpler to use, simpler to train, simpler to understand from the health care provider standpoint, we are doing exactly that. So paradoxically, the reason we are doing this is actually to limit hypo in the population, to improve outcomes in the population. And we do that by getting products like this out to more people.

Operator

And our next question comes from the line of Jonathan Block from Stifel.

Jonathan Block

Maybe just a couple of quick cleanups and then 1 on 3D. In terms of the cleanups, Stephen, are we now thinking new customer starts down, call it slightly less than 30% Q3 to Q4 sequentially? Again, then I might have missed it, but did you have any timing on FCL in terms of approval? And then I'll just ask the one on 3D.

Stephen Feider

Yes, John, more like down 20%. New patient starts in 4Q relative to Q3. And then do you want to take the other one?

Sean Saint

This is approval time line FCL. No, we haven't provided timing on that as of yet. Just start timing for the trial, which is relatively imminent. I don't remember the exact wording that we used.

Jonathan Block

Okay. And then just on 3D, and I'm sorry if I'm missing something or I didn't mean to beat it up, but Sean, why did you withdraw the 3D Intelligence filing rather than just call to answer the agency's questions? I'm not sure if that's sort of simulator related, but I just didn't have my arms around that. And just to be perfectly clear, still with the new approach that you're taking, this is still going to have sort of the 3 options, if you would, in terms of, and these are my words, but original, enhanced, and maybe importantly, the conservative option, if I've got that correct.

Sean Saint

Yes. None of that has changed. And that's a really important clarification on why we withdrew. The simple fact is that, we got to the end of the 90-day review period, and some of these questions kind of came up near the end, and that's okay. That happens sometimes, and we just didn't have the time to get through them. So when you get into a situation like that, at times you can get into a situation where the agency's like, "All right, look, I'm at the end of my time. I have to close this file." So I can either "disapprove it or you can pull it." And it's just kind of a procedural thing, like what everybody always does is pull it, answer the question, and resubmit.

But we would have loved to have answered the questions within the bounds of the previous file, but we were just at the end of the time, so we didn't really have that opportunity, unfortunately. But that is actually the point of why we say there is still a chance of getting clearance for this in Q4 because again, if we pick up where we were, then potentially that's actually possible. Because again, look, we acknowledge it. It sounds bad. It's not as bad as it is. It was just literally we ran out of time to answer all the questions. It wasn't a problem per se.

Actually, let me say one other thing on that. I'm not a MDUFA expert here, but my understanding is that, the agency has a certain number of their files that they're supposed to close within their statutory 90 days, and then they're allowed to go beyond with a few. So we do see 510(k)s that go beyond. It happens rarely, but it does happen. Most of them they're going to try and close. So that's just what happened here. But if people are like, "Oh geez, I've seen them go beyond," that's absolutely right. But most of them do not. And they try and meet their metrics on that. So we try and help them do that.

Operator

And our next question comes from the line of Mathew Blackman from TD Cowen.

Mathew Blackman

Can you hear me okay?

Sean Saint

Yes, I got you, Matt. How you doing?

Mathew Blackman

Good. Doing well. Sean, a question for you. I was actually hoping for maybe a, let's call it a state of the union on the sales force. Obviously, ahead of the Mint rollout, but particularly given your comments about needing to drive awareness of Mint earlier in the call. So just anything you'd be willing to share on just, again, the state of the union on the sales force, how the new reps have been ramping? To the extent you want to talk, perhaps not, just about the strategy you have in terms of the Mint rollout, who you're going to target out of the gate, et cetera. Just, again, any sort of updated thoughts on the sales force ahead of a pretty important commercial launch?

Sean Saint

Yes. Well, let me start with the awareness that we discussed earlier. The sales force, while they absolutely talk to users every day, primarily are calling on health care providers, right? So what we weren't sure about was the likelihood of a user who's not seeing their health care provider, et cetera, just sort of at home hearing about Mint in some way. Are they following us on socials? Are they checking out our website every day? Hard to predict how often that happens. But we don't think we have a problem getting the word out about Mint to health care providers, which is what our sales force is primarily engaged in doing. That was what the expansion was all about. It was about preparing us for that moment when we have Mint readiness, which we're nearly upon now.

So sales force ramp. I would say that you can see it in the numbers at some level. It's absolutely sort of decelerated, and that's absolutely expected. The -- we did a really good job, I think, of getting the word out on iLet with our previous, somewhat smaller group of reps. And we've had now 3 years, 3-plus years to get the word out there. Getting more reps in the field doesn't really inform too many more health care providers about iLet that weren't informed about it before. However, you are going to start to slowly increase the rate of scripts, and that's exactly what we see. However, on the cusp of a major launch, as you alluded to, we want to make darn sure that we can get that word out to as many health care providers as possible quickly with the number of times you have to visit them for them to be comfortable, again, in a short period of time. So we really needed to do this expansion prior to the launch of Mint to do that. Hopefully, that's some additional color for you.

Operator

And our next question comes from the line of Stephanie ELGHAZI from BofA.

Stephanie ELGHAZI

I wanted to ask on the process for getting Mint on formulary and how that factors into the revenue ramp for Mint next year. And is that process all factored into that 40% covered lives you mentioned for Mint at launch? Or is the, I guess, immediately addressable patient opportunity smaller because of that?

Stephen Feider

Stephanie, yes, great question. Look, you can hear it, I'm sure, in Sean and I's voice as we talk about the business that we are hugely excited for the upcoming Mint launch. Massive milestone for our company and allows us to compete in a very different way. So if you're an investor or you're an analyst looking at the opportunity, I think you're naturally asking first, is there demand for the product? And I hope we've convinced you, yes, by showing what the differentiation of it is. Then you're asking, can we manufacture the product? And I think Sean went into a lot of detail today that illustrates that. But then you're getting to a really important point, which is how can you guys be sure that Mint will be covered, or the market access, the insurance coverage on the product. And again, reiterating that we expect 40% insurance coverage at launch, growing to at least around 50% by the end of 2027.

Yes, so we're in a good position to do that for a couple of reasons, to obtain that coverage, that 40% number at launch for a couple of reasons, and very notable ones. Number one is that Mint is considered a patch pump for reimbursement purposes, meaning it is a Medicare Part D product, or at least that's the reimbursement designation. There's a nerd-level term here called the GPI code for the product that governs whether the product is considered a disposable product. Mint is. On both Medi-Span and First Databank, we are considered that distinction. So by default, we are considered a patch pump, which makes the reimbursement process dramatically easier than going -- than taking a tubed pump, which is considered medically reimbursed and achieving pharmacy coverage for it, which is what we have done historically. But in this case, with Mint, it's a lot easier. So That's number one is, it is considered a patch pump, which makes the reimbursement process much easier.

Number two is, we know how to do this, so we have the capability. There's 3 large PBMs that represent over 80% of all lives in the country. There's 100 underlying health plans associated with PBMs that, and combined with -- associated with PBMs that combined make up roughly 90% of all lives in the country. We have relationships with these decision-makers at these accounts. We know how to do this. We have a market access team. We've laid all the groundwork associated with the Mint reimbursement launch -- or the Mint launch for reimbursement purposes with everything we've learned from iLet reimbursement.

So I could go on and on about the individual accounts and like details underlying this, but that's why I have confidence in these numbers we're promising here for Mint launch, and that is a very important item, going back to my first point, if you're buying into the success and the outcome associated with Mint.

Operator

And our next question comes from the line of Richard Newitter from Truist Securities.

Richard Newitter

Just maybe going back to one that was asked earlier, I think, lots of permutations as to where kind of the demand could eventually be sourced from for Mint. One of the things I was curious on is, any quantification you could put around the existing iLet users in the pharmacy channel currently, and what you think that mix will look like as a percentage of the total Mint install base when we're maybe looking back at the end of '27. Is it reasonable to think that your existing iLet conversions could represent, I don't know, what, 30%, 25% of whatever installed base of Mint users you have by the end of next year? I'm just trying to get a sense for what's converting existing iLet in channel, in pharmacy channel users, and kind of what's truly incremental.

Stephen Feider

Yes, Rich. Fair question. I'm not going to give you the numeric answer for what I ultimately believe and I have modeled, but I'll give you a directional sense of what I think will happen here. I do think that many iLet users, for reasons I've communicated earlier, are going to prefer to wear Mint, for reasons I hope that are clear to you all. I do also believe that much of our insurance coverage that we will have on Mint will come from the existing contracts that we have on iLet and added amendments or relationships and wins that we've already had associated with iLet when we're trying to achieve coverage for Mint.

So what does that ultimately look like in terms of what like percentage of the new patients or patients we have next year on Mint? Well, it's important for that you know this first is that, we will likely be prioritizing to the extent where there's constraints on manufacturing capacity relative to demand. We will likely be prioritizing new users to Beta Bionics. And so, at that point, I think certainly at the start of our -- at our initial launch, where we're more likely to be capacity constrained, that will be resistant or that will be headwind towards more of our Mint install base being users who are coming from iLet. But over the course of the year, again, because I think a lot of those iLet users who have gotten their iLet or who are getting their iLet reimbursed in pharmacy today will have the ability to transition to Mint. I do think that it's plausible that we will see some of that conversion.

I also think it's plausible that people who purchased iLet and are purchasing supplies through DME for iLet will also convert to Mint. Now, important to remember there that, that's not a bad thing for us at all financially. So patients who are purchasing iLet supplies from us in DME, we're generating directionally around $70 a month. And Mint's reimbursement will be somewhere in the neighborhood of 6x the amount of revenue per month per patient than what we're getting for that iLet patient in DME. So there's a little bit of a mouthful there without, again, giving you the direct number, but I hope that's helpful.

Richard Newitter

Yes. No, it is. And maybe just another one. Just going back to churn and type 2, anything you're seeing in the market? You've been asked this question, I'm sure, in the wake of 2Q results from a competitor of yours. Anything you've noticed on type 2 and churn retention that's worth calling out?

Stephen Feider

Yes. We're not seeing any notable change in our churn or in our ability to retain patients some of them we have over the last -- than what we have over the last several quarters. So just generally, retention on the product remains really strong, and I think you'll see that by looking at our pharmacy. Or the best evidence of that is by looking at our pharmacy supply revenue relative to our install base or our perceived install base that you all have calculated.

Our type 2 retention on the product is actually just slightly better than our type 1 retention. I'm not advertising that as like some grand difference between the 2 or some like incredible characteristic of our business. I'm just answering the question. But no, there's no massive difference, but there is some discernible difference between type 2 and type 1 in terms of retention on our product, and type 2 is slightly better. And I have thoughts on why that could be, but just wanting to get you the direct answer.

Operator

Our next question is a follow-up from the line of Stephanie ELGHAZI from BofA.

Stephanie ELGHAZI

Sorry, I missed my follow-up earlier, but I just wanted to ask on the market, given there will be multiple patch or tubeless options in the market next year, so just curious how you are thinking about potential market expansion versus share taking. And I guess, how do you think about your competitive positioning and anything you'd be willing to say on your expected share capture potential on new patient starts with Mint?

Sean Saint

Yes. Stephanie, we're still in our infancy compared to some of the larger incumbents here. So when we think about that question, we think primarily about designing the right product and whether we take share or whether we expand the market, we do better either way, and we do that by designing a better product in both cases. So I'm not trying to be obfuscatory here. The answer is both, of course. In the past, there have been people who have chosen patch pumps for good reasons. They like that format, and those are people that we're giving an additional option to today with a product. Or not today, but soon. With a product that we believe has additional benefits.

There are other people that have chosen not to move to patch pumps today or any pump today because they didn't find the product that best met the needs for something they were looking for, and we believe that we're doing that as well. But I couldn't necessarily tell you exactly what portion of our expectation is from expansion versus share taking. For us, it's not really that important a distinction. So hopefully that's helpful.

Actually, I'll also say that, I think it just illustrates the fact that what we've done is, we've focused on making the best product that we can. And I think everybody's heard us talk about this for the last year or so. Mint absolutely represents the right architecture as far as we're concerned. We think we've given users the right options. We think we've given them the right features, the right architecture. Is it 100% perfect for all users? No. But that's never going to be the case. What we think we've done is made a product that's most applicable to most users, which is exactly what Beta Bionics has always been engaged in, right? We're trying to improve the outcome for more people with diabetes, and you do that by making a product that more people will use, that the lion's share of people will use, and that's what we're doing. And we think we've done a pretty good job of it, and we're really excited for 2027 to hopefully show the world that.

Stephen Feider

That's it for questions. Yes. Anything else you want to say in closing?

Sean Saint

Maybe just reiterating what I just said, which is 2027's going to be a fun year. We're really excited for Mint. I think you hear that in our voices, you hear that in the plans we're making. We do believe it's a great product. And look, I'm personally wearing it right now, and I'm loving it. I hope to bring that experience to a hell of a lot more people.

So thanks, everybody, for joining today. We really appreciate your time, and I look forward to catching up with each one of you.

Stephen Feider

Take care, everybody.

Operator

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