クライオポート (CYRX) 2026年第3四半期決算説明会：売上高14%増、ガイダンス引き上げ

主要ポイント

• 2026年第3四半期の売上高は、ライフサイエンス・サービス部門の売上高が前年同期比18%増となったことが牽引し、同14%増の5,020万ドルとなりました。
• ライフサイエンス・サービス部門が総売上高の57%を占めたほか、商業段階の細胞・遺伝子治療関連の顧客からの売上高は20%増加しました。
• 調整後EBITDAは110万ドルと2四半期連続で黒字を確保し、前年同期から180万ドル改善しました。
• クライオポートが当四半期末時点で支援する対象は、23件の商業化治療法と、99件の第3相プログラムを含む過去最高の788件の治験に達しました。
• 経営陣は2026年通期の売上高見通しを1億9,700万〜1億9,900万ドルへ引き上げました。これは中央値で前年比約12%の成長を意味します。
• 経営陣は2026年の残りの期間に、さらに5件のBLA（生物製剤承認申請）/MAA（販売承認申請）提出、2件の新規治療法承認、および1件の対象地域拡大に伴う追加承認の可能性があると見込んでいます。

主要財務データ

事業および営業実績

ライフサイエンス・サービス部門は引き続きクライオポートの主たる成長エンジンとなりました。経営陣は18%の増収について、世界的な細胞・遺伝子治療の患者数の増加と、同社の統合サプライチェーン・ソリューションの導入拡大によるものと説明しています。

商業段階の細胞・遺伝子治療の売上高は現在、全社売上高の20%を占めています。治験関連の活動を含めると、細胞・遺伝子治療が売上高の約47%を占めます。

治験パイプラインは過去最高の788件に達しました。第3四半期中に31件が追加され、完了した8件を含む22件が除外されました。経営陣は、完了件数の増加はパイプラインの成熟を示していると述べています。

ライフサイエンス・プロダクト部門の売上高は8%増加しました。MVEバイオロジカル・ソリューションズ（MVE Biological Solutions）は、アニマルヘルス分野の堅調な需要や、超低温フリーザー製品群「Fusion」の需要増加の恩恵を受けました。米州、アジア太平洋、EMEAの各地域で成長を記録しました。経営陣はアニマルヘルス需要について循環的であると説明し、直近の好調さは牛の繁殖および世界的なタンパク質生産分野に集中していると述べました。

通常、中国は総売上高の3%〜4%を占めています。経営陣は中国での大幅な成長を見込んでいないものの、MVEの現地事業は安定化したと述べています。中国拠点は国内および輸出向け製品を製造するとともに、ジョージア州ボールグラウンドおよびミネソタ州ニュープラーグにあるクライオポートの施設へ部品を供給しています。

バイオストレージおよびバイオサービス部門は前年同期比20%超の成長を維持しました。経営陣は、短期バイオストレージ、キッティング、ラベリング、同種異系（他家）治療のフルフィルメントに支えられ、同事業が引き続き2桁成長を維持すると見込んでいます。ベルギーにおける無菌キッティング業務は顧客から好意的に受け入れられています。

IntegriCellは依然として初期段階にありますが、ヒューストンおよびベルギーの拠点において複数の顧客が安定した患者処理量に寄与しています。クライオポートは2027年にニュージャージー州モリスプレインズにIntegriCellの凍結保存機能を追加する計画です。

経営陣による業績見通し

クライオポートは2026年通期の売上高見通しを1億9,700万〜1億9,900万ドルに引き上げました。経営陣によると、中央値は前年比約12%の成長を示唆しており、これは年初来の同社の成長率と一致しています。

この業績見通しは、主に既存顧客と最近の事業モメンタムに基づいています。新規治療法の承認による売上高は、発売開始から規模拡大までに通常時間を要することから、実質的には含まれていません。

経営陣は、2026年第4四半期に処方せん薬ユーザーフィー法（PDUFA）目標期日を迎えるアーセルエックス（Arcellx）およびカプリコール（Capricor）に関連する2件の新規治療法承認を見込んでおり、11月に1件、12月にもう1件の決定が下される見通しです。従来2026年に見込まれていた4件の申請は2027年にずれ込みました。

クライオポートは、グローバル・サプライチェーン・センター全体の稼働率上昇に伴い、2027年以降に調整後EBITDAマージンがさらに拡大すると見込んでいます。経営陣は粗利益率55%、調整後EBITDAマージン30%という長期目標を改めて表明しましたが、これらは短期的なガイダンスではなく目標として提示されています。

リスクと注視点

• 経営陣は、特定されていない外部環境および政府関連の不確実性を理由に、第4四半期の業績見通しに対して慎重な姿勢を維持しました。
• 従来2026年に見込まれていた4件の薬事申請が2027年に延期されたことは、治験依頼者（スポンサー）および規制当局の審査プロセスに伴う時期的なリスクを浮き彫りにしています。
• フランスのパリおよび米カリフォルニア州における新たなバイオサービス拠点の立ち上げは、当初は施設レベルの利益率を圧迫する可能性がありますが、経営陣は組織全体の広範な成長がその影響を相殺すると見込んでいます。
• MVEのアニマルヘルス事業は循環的であり、直近の好調さは牛の繁殖需要に集中しています。
• 中国の売上高は安定しているものの、大幅な成長は見込まれていません。

アナリスト質疑応答のハイライト

経営陣は、第4四半期の業績は製品ではなく主にサービス部門によって牽引される見込みであると述べました。同社は、商業段階の細胞・遺伝子治療分野で継続的な勢いがあるにもかかわらず、業績見通しは保守的であると説明しました。

クライオポートは、取扱量の増加に伴い、拡充されたグローバル・サプライチェーン・ネットワークがさらなる営業レバレッジを生み出すと期待しています。パリとカリフォルニア州におけるバイオサービス機能の拡充は、2027年にほぼ完了する見通しです。

今後の商業化上市に関して、経営陣はギリアドが権利を保有するアーセルエックスの治療法や、自己免疫疾患向けとして初の承認となる可能性がある2027年初頭の承認候補を挙げました。ただし、具体的な増収見通しについては提示しませんでした。

第3相試験プログラムの増加要因として、セクター全体の資金調達環境の改善、豊富な資金力を持つ大手企業への集約、ならびにより明確な商業的潜在力を持つプログラムに対する中小バイオテクノロジー企業の優先度向上が挙げられました。

クライオジーン（CryoGene）の新たな極低温テクニカルサービスは、顧客需要に応えたものと説明されました。経営陣は、ヒューストン、サンアントニオ、および開設予定のタンパの各拠点とともに、このサービスが長期的にさらなる売上高の貢献をもたらすと見込んでいます。

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

[Operator Instructions]

As a reminder, this call is being recorded. I will now turn the call over to your host, Todd Frommer, from KCSA Strategic Communications. Please go ahead.

Todd Fromer

Thank you, operator. Before we begin today, I would like to remind everyone that this conference call contains certain forward-looking statements. All statements that address our operating performance, events, or developments that we expect or anticipate occurring in the future are forward-looking statements. These forward-looking statements are based on management's beliefs and assumptions on information currently available to our management team. Our management team believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. We do not undertake any obligation to publicly update or revise any forward-looking statements whether as a result of new information or future events or otherwise, except as required by law. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results, events, and developments to differ materially from our historical experience and our present expectations or projections.

These risks and uncertainties include, but are not limited to, those described in Item 1A, Risk Factors, and elsewhere in our Annual Report on Form 10-K filed with the Securities and Exchange Commission and those described from time to time in the other reports which we file with the Securities and Exchange Commission. As a reminder, Cryoport has uploaded their third quarter 2026 In Review document to the main page of their Cryoport, Inc. website. This document provides a review of Cryoport's financial and operational performance and a general business outlook. Before I turn the call over to Jerry, please note that because of the strategic partnership that has been established with DHL Group and the related sale of CryoPDP to DHL in June 2025, CryoPDP's financials, which were previously a part of Cryoport's Life Sciences Services reportable segment, are now presented as discontinued operations. Please note that unless otherwise indicated, all revenue figures discussed today will refer to continuing operations. This includes Cryoport's fiscal year 2026 revenue guidance.

It is now my pleasure to turn the call over to Mr. Jerrell Shelton, Chief Executive Officer of Cryoport. Jerry, the floor is yours.

Jerrell Shelton

Thank you, Todd. Good afternoon, everyone. With me today is our Chief Financial Officer, Robert Stefanovich; our Chief Scientific Officer, Dr. Mark Sawicki; and our Vice President of Corporate Development and Investor Relations, Thomas Heinzen. I'm pleased to report that Q3 delivered another strong quarter with revenue of $50.2 million, representing a 14% year-over-year growth. Life Sciences Services continued to be a key growth driver, with revenue increasing 18% and representing 57% of our total company revenue. Within services, our core cell and gene therapy business delivered very strong results, with revenue from commercial cell and gene therapy clients increasing 20%. These results reflect the growing number of patients worldwide receiving cell and gene therapy treatments and the continued adoption of our integrated supply chain solutions.

During the third quarter, Cryoport continued to expand its leadership position within the cell and gene therapy ecosystem, ending the quarter supporting 23 commercial therapies as our client, Replimune, received accelerated FDA approval for TUDRIQEV for the treatment of adults with unresectable advanced cutaneous melanoma, a skin cancer that has spread too widely or deeply to be safely or completely removed with surgery. We also concluded the quarter with a record clinical trial pipeline of 788 clinical trials, a net increase of 43 clinical trials over the prior year, with 99 of these trials being in Phase 3. We believe our industry-leading position will continue to drive commercial revenue as these therapies receive additional regulatory approval. Based on the information we have today, for the remainder of the year, we expect another 5 possible BLA/MAA application filings, 2 potential new therapy approvals, and 1 additional supplemental approval for geographic expansion. It's important to note that both of these potential new therapy approvals have received PDUFA dates from the FDA and are scheduled for the fourth quarter of this year.

We also posted solid Life Science Products revenue with growth of 8% for the quarter, reflecting MVE's Biological Solutions position as the global leader in cryogenic systems. Specific revenue contributors in the third quarter included strong demand for animal health customers as well as increasing demand for our Fusion line of cryogenic freezers. MVE continues to be the industry leader and a consistent cash flow generator, while also providing support and meaningful synergies with our Life Sciences Services business. Our integrated end-to-end platform across the life sciences ecosystem, combined with disciplined execution and increasing utilization of our global supply chain center network, positions us to scale with the industry efficiently and exercise operating leverage as we continue to advance towards sustained profitability. This was also shown in our financial results as we report in our second consecutive quarter a positive adjusted EBITDA of $1.1 million for the quarter, a $1.8 million improvement year-over-year.

With our progress to date on our Pathway to Profitability initiative, we believe our financial results will continue to improve. During the third quarter, our global supply chain center in Paris, France, received ISO 9001 and ISO 21973 certifications. As a result, Cryoport Systems received the Healthcare and Pharmaceutical Supply Chain Excellence Award at the 2026 Supply Chain Excellence USA Awards. This was largely in recognition of becoming the first global supply chain solutions provider to achieve ISO 21973 certification, which is the first international standard developed specifically to address the transportation risk associated with human cells for therapeutic use. We are extremely proud to achieve these certifications and industry recognition.

Taking these initiatives and achievements into account, along with our strong year-to-date performance, combined with our increased visibility, expanding support of commercial therapies, deepening customer relationships, a robust clinical trial pipeline, and healthy demand for MVE's industry-leading products, we are well positioned to meet our 2026 financial goals. Therefore, we are raising our full year 2026 revenue outlook to $197 million to $199 million. This concludes my remarks for today. Now I'll ask the operator to open the floor for your questions.

Operator

[Operator Instructions]

Your first question comes from Puneet Souda at Leerink Partners. Please go ahead.

質疑応答

Puneet Souda

Hi, this is Phillip on for Puneet. I wanted to ask about guidance. By our math, you raised the midpoint by $4 million on a $1.6 million beat, implying 4Q of $50 million to $52 million. What drives the 4Q step-up in services versus products, and how much macro caution is still embedded in the range?

Robert Stefanovich

I think overall, you know, what we did when we looked at guidance for the full year is really to give a prudent guidance for the full year. We had very, very strong results really over the last 3 quarters in terms of revenue growth and also expansion of our bottom line. And so looking into 4Q and looking at the growth prospects, we think this was the right level of guidance to provide for the year. It looks at a 12% growth year-over-year, and there's certainly upside potential for that as well.

Puneet Souda

Got it. That makes sense. Follow-up question on pipeline expectations. I think in August, I believe you expected 11 more filings and 5 approvals this year, and correct me if I'm wrong, but now it's 2 filed, 5 more possible, and 2 approvals. The question is, what moved exactly? Is it FDA timing or sponsor decisions? And separately, is it safe to assume that the 2 decisions expected in 4Q are the 2 multiple myeloma drugs? I think both have PDUFA dates in December. Thanks.

Thomas Heinzen

Thanks for the question. You're correct. We did in 2Q predict 11 applications, 5 approvals. In 3Q, we had 2 filings and 1 approval. And now we're having an outlook for 5 more with 3 approvals. For applications we thought would happen in 2026, they did get pushed into 2027. That happens. And then as far as the approvals that have, or the upcoming PDUFA dates, yes, 1 is Arcellx and 1 is Capricor. One in November, 1 in December.

Puneet Souda

Thank you so much. I'll hop back in the queue.

Operator

Your next question comes from Mac Etoch from Stephens. Please go ahead.

Unknown Speaker

Hey, sorry, I think you'll be able to find the mute button by now. I'd love to get a sense of what you're seeing within your, or just an update on the China for China strategy now and how that's progressing.

Jerrell Shelton

Would you restate that, Mac, again? I missed part of that. Yes.

Unknown Speaker

Yes, sorry about that. I just hope to get an update on the China for China strategy now that you have the production facilities up and running in that area. Just love to get a sense for how demand's trending.

Jerrell Shelton

Well, you're talking about the Global Supply Chain Center Network, and we...

Unknown Speaker

MVE. MVE China.

Jerrell Shelton

Oh, yes, okay. So your question's about MVE. MVE is robust, it's stable, its market seems to have stabilized. Its strength, as I mentioned in my comments, is in the animal health market, but all 3 plants are running very well and the market is cooperating. So we see solid mid-single-digit growth, you know, on a continued basis.

Robert Stefanovich

Yes, and then just for China specifically, China revenue for us is somewhere in the range typically of 3% to 4% overall of total revenue. And we don't see significant growth in China, but it certainly has stabilized from an MVE perspective. And you know, you have to remember...

Jerrell Shelton

Remember, our China operation supplies components for our other operations both in Ball Ground, Georgia, and New Prague. So it does produce product that's sold domestically, it produces export products. I was recently there and saw a number of orders going to Pakistan and other places, particularly for animal health. But it is an internal supplier as well as an external supplier, but it's doing well.

Unknown Speaker

I appreciate the color there. And then maybe touching on those additional facilities that are coming online. How should we think about the margin cadence as we look towards 4Q and into 2027?

Robert Stefanovich

Yes, I think, look, if you step back over the last several years, we've made significant investments to expand, 1, our first-mover leadership position, increase our wallet share through the new standard-setting services. At the same time, we've expanded our global supply chain centers, and this will substantially be complete in 2027 with the added BioServices capabilities in Paris, France, and Santa Ana, California. This provides both with the capabilities and capacity to support the expected growth in cell and gene therapies. And that really drives the operating leverage that we expect to see. You see some of that kick in in 2Q and 3Q with, you know, driving positive adjusted EBITDA and then growing it in 3Q. But we certainly expect more room for operating leverage going forward as we come online with these additional services. Overall, you know, we look at cell and gene therapy market, and that's really why we've built out the global supply chain centers over the last couple of years.

If you look at the Alliance for Regenerative Medicine recent report, they expect cell and gene therapies to grow at a 6-year 34% CAGR from $10.2 billion in 2025 to roughly $60 billion in 2031. So we're well positioned to capture that additional revenue going forward.

Unknown Speaker

I appreciate the color.

Operator

Your next question comes from Matt Hewitt of Craig-Hallum Capital Group. Please go ahead.

Matthew Hewitt

Maybe first up, regarding the increased guidance, and you touched on this a little bit, I think, earlier in the first question, but how much of that is a factor of the broad-based strength that you're seeing in the market versus the new approval? Is there a way to parse out what you're expecting for that 1 new approval that you saw in the quarter?

Jerrell Shelton

No, Matt, I think they go hand in hand. There is a broad base that we're looking at, both in products and in services. And, you know, you saw clinical increases in the quarter in our review piece, and you also have seen, you know, that we grew commercial therapy, I mean commercial shipments by about 20% or the commercial activity and the service is about 20%. So it's broad-based, it's based on all of those things. But looking at it...

Robert Stefanovich

And in particular we don't expect, you know, new approvals to—that's really not baked into the guidance that we've given because new approvals typically take a while to ramp, depending on the type of therapy, depending on the company that's actually launching the therapy. So in our guidance, that's really not reflected as a revenue stream. This is really based on the clients we're currently serving, on the growth that we've experienced over the last 3 quarters. Right. We look at year-to-date growth for the 3 quarters, it's about 12%. The midpoint of our guidance is 12%, so we continue or expect that growth to continue into 4Q.

Matthew Hewitt

Got it. And then regarding the new facilities in California and France, as those get up and running, just a reminder here, does that weigh on the gross margins a little bit initially and then as you start to get better utilization there, you start to see those margins climb back up, or is there really no impact on gross margins once you kind of open the doors, if you will?

Robert Stefanovich

That's a good question. Selectively, if you just look at those facilities, yes, there will be some margin impact, but overall, because we're seeing growth throughout our organization, that will be covered by the overall growth in margins from the other facilities. Maybe just a clarification, both of those sites online with our BioLogistics solutions. What we're adding to both sites is the additional BioServices capabilities to really, you know, add or to provide the full comprehensive platform that we've built.

Matthew Hewitt

Got it. Thank you.

Operator

Your next question comes from Richard Baldry of Roth Capital. Please go ahead.

Richard Baldry

Looks like MVE had its best quarter in about 3 years. I'm sort of curious if you piece its revenues internally apart. Is most of that growth being driven by the new Fusion offering? And then how sort of sustainable, extensible do you think the run rate revenues feel like? Thanks.

Jerrell Shelton

The animal health business is cyclical and so, you know, we've had a strong couple of quarters. That's mostly animal husbandry, mostly in the bovine area of reproduction, and that's been global. You know, there's a demand for some kind of a surge, demand for protein, but we've experienced that and we've been strong on that side. Freezer side has been fine. And it hasn't been as robust as the dewar side of the business, that is the shipping side of the business. But the freezer business is very healthy. And of course the Fusion line started to ship and had some increased demand, so that's helped as well.

Robert Stefanovich

And then regionally or geographically, we've seen actually for a quarter, 3Q over 3Q last year, growth in all 3 regions: So the Americas, Asia-Pac, and EMEA.

Richard Baldry

Then when you look at the move to adjusted EBITDA positive, some of that's been with OpEx sort of controlled to steady. Do you think you're at a good run rate here? Do you think you're still looking for places to get greater efficiencies? Or does it sort of grow in line or maybe add a little subset to the top line from here forward?

Jerrell Shelton

So, Rich, Robert will further comment on this, but the operating leverage naturally gives us leverage. It gives us operating leverage, and we've built out these capacities for what's coming, for being able to handle this demand as it does materialize. Of course, they have to be fully validated, so it was a drag for a while, but now we're beginning—we're not totally there—we're beginning to get on the other side of that, and that's where our Pathway to Profitability theme is centered. We certainly are cost conscious, but we also know that we have to deliver quality to this.

But Robert, do you have other?

Robert Stefanovich

Yeah, no, it's really like I mentioned, you know it was building out the capabilities and capacity that we needed to have on a global basis to support the upcoming commercialization of more cell and gene therapies. And we did state that our overall goal, in terms of long-term goal, gross margin is 55%, long-term goal for adjusted EBITDA is 30%, and we definitely see that pathway to those targets. I think as you have more volume go through these centers, and global supply chain centers, you'll certainly see also greater ability for efficiencies that we believe that we'll have within our network. Certainly, we would expect further EBITDA margin expansion in '27 and beyond.

Richard Baldry

It's sort of been addressed, maybe looked at a little more detail, but if you look sequentially on the 50 to 52 implied revenue, it's sort of flat up. What really gates whether it's an up quarter or not?

Jerrell Shelton

He's talking about—say that again, Rich, what gates whether it's in a quarter or not. What is that? What you said.

Richard Baldry

The revenue guide implies flat to up about 2 million sequentially. So I'm sort of curious what factors the services would tend to be, I think, sort of sequentially higher. Is it really product-driven that's going to be the up or down on it?

Jerrell Shelton

No, it's services driven, but Rich, in our guidance, we just—we have momentum, but we chose to be prudent and conservative on that side. Look, there's still a lot of external things going on, especially with our government and so forth, that could happen and we have to take those into consideration. As Robert stated earlier, we pushed out the 12% and increased our guidance by the midpoint to that extent. But we certainly have a lot of momentum and we certainly have a bullish outlook on what's coming. In terms of guidance, we did maintain a conservative stance.

Richard Baldry

Thanks.

Operator

Your next question comes from Subbu Nambi of Guggenheim Securities. Please go ahead.

Unknown Speaker

Hi, this is Ethan on for Subbu. I just wondered beyond animal health, you know, how did reproductive medicine or other MVE markets trend in 3Q? And I was just wondering what your outlook for those markets is in just going into 2027.

Robert Stefanovich

Yes, we've seen growth, but really if you step back and look at our company, the main focus is on cell and gene therapies. That's really where we expect to see the growth. The commercial cell and gene therapy revenue alone now represents 20% of total revenue. And if you add the clinical trials... while cell and gene therapy revenue is about 47%. So yes, we have seen definitely good, especially in the animal health side, we've seen on the product side significant demand, and that's related really to the need for protein production globally. And so we've seen that over the last 3 quarters and reproductive medicine is growing as well.

Unknown Speaker

Thank you.

Operator

Your next question comes from Anna Snopkowski of KeyBanc Capital Markets. Please go ahead.

Anna Snopkowski

My first one is on the BioStorage and BioServices business, which I know is a smaller part of the company, but this has been seeing strong growth with I think over 20% growth over the last 7 quarters. So do you think you could just touch on what is driving this and how should we think about this business over the long term?

Robert Stefanovich

You're absolutely right. We did have very strong 3Q and really over the last several quarters saw in excess of 20% growth year-over-year and we expect that to continue. We're very bullish about BioStorage, BioServices. As I mentioned, we're just expanding that service in Paris, France, and in San Francisco, to LATAM because we see a growing need. Clients are really looking for us to provide a comprehensive solution. So not just BioLogistics for BioServices, but really a combined solution of both. So we do expect that to continue to be a double-digit grower. And this really is comprised of short-term BioStorage, kitting, labeling, and, of course, allogeneic therapy fulfillment moving forward.

Mark W. Sawicki

Yes, let me just add a little bit to that. So Robert's exactly correct. We are seeing continued diversification of our client base into our BioServices and BioStorage business. And we also launched our sterile kitting operations of this year and we've seen extremely positive traction as it relates to uptake of that business in Belgium, and then that'll be coming online out of the Houston site next year as well.

Anna Snopkowski

Great, thank you. And then just one follow-up on IntegriCell, I know this is part of a longer, larger program initiative, but how is this rolling out so far and how do you think about potentially rolling into new regions and how do you exactly pick which regions you expand into?

Mark W. Sawicki

Yes, so, you know, IntegriCell is still, you know, as we had mentioned, in its early stages. However, we do have multiple clients that are onboarded that are now contributing consistent patient counts into both locations: the location in Houston as well as the location in Belgium. You know, ultimately our goal here is to, over time, provide a competency that provides a network of cryopreservation competencies in both geographies. In fact, we're going to be bringing online the IntegriCell cryopreservation activities in our Morris Plains location as well next year in support of multiple of our clients who have asked us to have diversification of sites and we'll continue to see benefit from that. You know, this is, you know, obviously a key opportunity for us, as well as the broader cell and gene market. And I think you've heard us say this before, you know, standardization of cryopreservation competencies is something that is extremely important, and it will become more important as these therapies continue to expand, but it also provides the competency for companies that we're working with to expand in the community care setting that don't have the infrastructure to support, you know, any sort of processing activity on site. And so they can now engage IntegriCell to support their community care expansion initiatives and still have the, obviously the regulated processing competency for those sites.

Anna Snopkowski

Thank you.

Operator

Your next question comes from David Larsen of BTIG. Please go ahead.

David Larsen

Can you please talk about expected commercial launches in '27 and '28 and the incremental revenue lift, please? Thank you very much.

Thomas Heinzen

Sure, David. Thanks for the question. Or do you want to take it, Mark?

Mark W. Sawicki

No, you can go ahead, Tom. That's fine. I might add to it.

Thomas Heinzen

Sure, we've got 2 more that we think will commercialize this year and then of course we said we have more filings, 5 more that we expect. I think the Street's really looking at 2 main ones. One is the Arcellx product that now is owned by Gilead. There is a lot of—Gilead's talked about it a lot on their last quarterly call.

And then there's a therapy that could be approved early in '27 that could be the first approved for an autoimmune disease. So that would be a milestone event for the industry. Overall we're very bullish on the outlook for commercial therapies, for the number of commercial patients being treated across the country and across the globe.

Mark W. Sawicki

And I think one example of that is the progression of the Phase 3 programs that we're supporting. I think you've seen over the last few quarters a significant increase in the number of active Phase 3 programs, which shows that a significant increasing percentage of our pipeline is moving towards those types of regulatory filing events, which we view as extremely positive for the long-term prognosis for the cell and gene space.

David Larsen

That's very helpful. Thanks very much. Really appreciate it. Congrats on a great quarter.

Thomas Heinzen

Thank you, Dave.

Operator

Your next question comes from Matt Stanton of Jefferies. Please go ahead.

Matthew Stanton

Maybe to pick up to some of what Mark was just talking about there on the Phase 3 ads, I think you had 5 all of last year. I think you have 13 this year, so really nice progress there. Is any of that tied to better funding we've seen out there? Is it just timing as the earlier stage stuff moves through the pipeline? Any more color on that? And then just talk about more broadly, to go to the prior question, just between the existing 23 and some of the new ones coming in, in the Phase 3 at almost 100 now, durability for a commercial to grow, you know, kind of 20-plus into '27. Thanks.

Mark W. Sawicki

Yes, I think, you know, the acceleration that you're seeing is a combination of factors. So, you know, as a comment put in, we publish this in the review, that there is an increase in funding in this space and so you do see a rebound in support of cell and gene from the financial market standpoint, which is extremely positive. You also see continued consolidation activity where you have larger entities. A good example of this is the Arcellx acquisition by Gilead, where they now have obviously significantly deeper pockets as well as a more mature commercial infrastructure to be able to rapid launch and scale these things very, very quickly. And then you also have continued prioritization of the smaller biotech space where they focused, and part of the challenge you saw a few years ago was the consolidation of some of these programs, and the clinical trial ads had slowed down, but it's now re-accelerating. But you're also seeing a more focused approach to those therapies that have a definitive, definitive commercial outcome. And so they're pushing most of the resources into getting their first or second commercial therapy across the line. So I think it's a combination of all of those.

I'm not sure if Tom wants to add anything to that.

Thomas Heinzen

I'd just add some color on the pipeline. In 3Q, we had 31 ads come in and 22 removed. Of the 22 removed, you had 8 trials completed. We're still seeing that trend of the number of completions being a good thing. That's maturation.

Matthew Stanton

Yes, I appreciate the color there from both of you. Thanks. And then, you know, one other one, I saw CryoGene launched a new offering, or I guess division, Cryogenic Technical Services, CTS. Can you talk about the logic behind this, and is this something that you will be able to monetize as a service moving forward within CryoGene? Thank you.

Robert Stefanovich

I think for CryoGene, it's really a natural response to the client demand. CryoGene obviously has a very, very strong long-term foothold in Texas, especially in Houston, and with all the medical centers, including MD Anderson. It's expanding the service offering based on client demand. So that will contribute over time in additional revenue for CryoGene. They have sites in Houston and in San Antonio, and obviously we've talked in the past about the additional site that they're setting up for the Moffitt Cancer Center in Tampa, which will be up and running later in 2026.

Matthew Stanton

Super, thank you.

Robert Stefanovich

Thanks, Matt.

Operator

There are no further questions at this time. I will now turn the call back over to Mr. Shelton for closing remarks.

Jerrell Shelton

I think you can see, ladies and gentlemen, from the conversation and from the questions and answers, we have a lot of positive things going on. We have fantastic momentum. We've raised our guidance. We had a terrific quarter. And most importantly, we have a really, really bright future. In closing, our strong third quarter and year-to-date results demonstrated the continued ramp of global patients being treated with cell and gene therapies, as well as strong customer adoption of our integrated supply chain solutions. With the 23 commercial therapies we currently support and our record clinical trial pipeline, we're on a solid growth trajectory as we continue to expand our position across the cell and gene therapy ecosystem.

We remain focused on our Pathway to Profitability initiative and are making significant progress as highlighted by our $1.8 million year-over-year improvement in adjusted EBITDA for the quarter. We're extremely proud of what we've achieved so far, but more importantly, we're excited about what we intend to achieve going forward as Cryoport continues to be an essential partner in supporting the life sciences industry and especially the cell and gene therapy part of that industry.

I want to thank all of our team members and other stakeholders whose hard work and dedication have helped us make today's results possible. We thank you for joining us today. We appreciate your continued interest and support. We look forward to sharing our continued progress with you when we report our full year financial results. We wish everyone a good evening.

Operator

Ladies and gentlemen, that concludes today's conference call. Thank you for your participation. You may now disconnect.

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