크라이오포트(CYRX) 2026년 3분기 실적 발표 콘퍼런스콜: 매출 14% 증가, 가이던스 상향

핵심 요약

• 2026년 3분기 매출은 생명과학 서비스 매출이 전년 동기 대비 18% 증가한 데 힘입어 전년 동기 대비 14% 늘어난 5,020만 달러를 기록했다.
• 생명과학 서비스는 총매출의 57%를 차지했으며, 상업화 세포·유전자 치료제 고객사 관련 매출은 20% 증가했다.
• 조정 EBITDA는 110만 달러로 2개 분기 연속 흑자를 기록했으며, 전년 동기 대비 180만 달러 개선됐다.
• 크라이오포트는 이번 분기 말 기준 23건의 상업화 치료제와 99건의 임상 3상 프로그램을 포함해 사상 최대인 788건의 임상시험을 지원했다.
• 경영진은 2026년 연간 매출 가이던스를 1억 9,700만~1억 9,900만 달러로 상향 조정했으며, 이는 중간값 기준 전년 대비 약 12% 성장을 의미한다.
• 경영진은 2026년 잔여 기간 동안 추가로 5건의 잠재적 생물의약품 허가신청(BLA)/판매허가신청(MAA), 2건의 신규 치료제 승인 가능성, 1건의 지역 확장 보완 승인을 예상하고 있다.

주요 재무 데이터

사업 및 영업 실적

생명과학 서비스는 크라이오포트의 주요 성장 동력으로 유지됐다. 경영진은 세포·유전자 치료제에 대한 전 세계 환자 수 증가와 회사의 통합 공급망 솔루션 채택 확대를 18%의 매출 증가 요인으로 꼽았다.

상업화 세포·유전자 치료제 매출은 현재 회사 총매출의 20%를 차지한다. 임상시험 활동까지 포함하면 세포·유전자 치료제 부문이 매출의 약 47%를 차지한다.

임상 파이프라인은 사상 최대인 788건에 달했다. 3분기 동안 31건의 시험이 추가되고 완료된 8건을 포함해 22건이 제외됐다. 경영진은 완료 건수 증가가 파이프라인 성숙을 나타낸다고 설명했다.

생명과학 제품 매출은 8% 증가했다. MVE 바이오로지컬 솔루션스(MVE Biological Solutions)는 동물 건강 부문의 탄탄한 수요와 퓨전(Fusion) 초저온 냉동고 라인에 대한 수요 증가의 수혜를 입었다. 미주, 아시아·태평양, EMEA(유럽·중동·아프리카) 전역에서 성장이 기록됐다. 경영진은 동물 건강 수요가 순환적이며, 최근의 강세는 소 번식 및 글로벌 단백질 생산에 집중되어 있다고 설명했다.

중국은 통상 총매출의 3~4%를 차지한다. 경영진은 중국에서 큰 성장을 기대하지는 않으나 MVE의 현지 사업이 안정화됐다고 밝혔다. 중국 법인은 내수 및 수출용 제품을 생산하는 동시에 조지아주 볼그라운드와 뉴프라하에 위치한 크라이오포트 시설에 부품을 공급하고 있다.

바이오스토리지(BioStorage) 및 바이오서비스(BioServices)는 전년 동기 대비 20% 이상의 성장세를 이어갔다. 경영진은 단기 바이오스토리지, 키팅(kitting), 라벨링 및 동종 치료제 풀필먼트에 힘입어 해당 사업부가 두 자릿수 성장을 이어갈 것으로 전망했다. 벨기에의 멸균 키팅 사업은 긍정적인 고객 반응을 얻고 있다.

인테그리셀(IntegriCell)은 아직 초기 단계에 머물러 있으나, 여러 고객사가 휴스턴과 벨기에 시설에서 안정적인 환자 물량을 제공하고 있다. 크라이오포트는 2027년 모리스플레인스에 인테그리셀 초저온 보존 역량을 추가할 계획이다.

경영진 가이던스

크라이오포트는 2026년 연간 매출 전망치를 1억 9,700만~1억 9,900만 달러로 상향 조정했다. 경영진은 중간값이 회사의 연초 이후 누적 성장률과 일치하는 전년 대비 약 12%의 성장을 의미한다고 밝혔다.

이번 가이던스는 주로 기존 고객과 최근의 영업 모멘텀에 기반하고 있다. 치료제 출시는 통상 규모를 확대하는 데 시간이 걸리기 때문에 잠재적인 신규 치료제 승인에 따른 매출은 유의미하게 포함되지 않았다.

경영진은 2026년 4분기 아셀릭스(Arcellx)와 카프리코(Capricor) 관련 FDA 전문의약품 허가 신청자 수수료법(PDUFA) 기한에 따라 2건의 신규 치료제 승인 가능성을 예상하고 있으며, 11월에 1건, 12월에 1건의 결정이 나올 것으로 전망하고 있다. 당초 2026년으로 예상됐던 4건의 신청은 2027년으로 연기됐다.

크라이오포트는 글로벌 공급망 센터 전반의 가동률이 상승함에 따라 2027년 이후 조정 EBITDA 마진이 추가로 확대될 것으로 예상하고 있다. 경영진은 총마진 55%와 조정 EBITDA 마진 30%라는 장기 목표를 재확인하면서, 이를 단기 가이던스가 아닌 중장기 목표로 제시했다.

리스크 및 주목할 점

• 경영진은 명시되지 않은 대외 및 정부 관련 불확실성으로 인해 4분기 가이던스에 대해 신중한 입장을 유지했다.
• 당초 2026년에 예상됐던 4건의 규제 신청이 2027년으로 지연된 것은 스폰서 및 규제 절차와 관련된 일정 리스크를 보여준다.
• 프랑스 파리와 캘리포니아의 신규 바이오서비스 역량은 초기에 시설 단위 마진에 부담을 줄 수 있으나, 경영진은 전사적 차원의 성장이 이러한 영향을 상쇄할 것으로 기대하고 있다.
• MVE의 동물 건강 사업은 순환적이며, 최근의 강세는 소 번식 수요에 집중되어 있다.
• 중국 매출은 안정화됐으나 유의미한 성장을 달성하지는 못할 것으로 예상된다.

애널리스트 Q&A 주요 내용

경영진은 4분기 실적이 제품보다는 주로 서비스에 의해 견인될 것이라고 밝혔다. 회사는 상업화 세포·유전자 치료제 활동의 지속적인 모멘텀에도 불구하고 전망을 보수적으로 설명했다.

크라이오포트는 물량 증가에 따라 확장된 글로벌 공급망 네트워크가 추가적인 영업 레버리지를 창출할 것으로 기대하고 있다. 파리와 캘리포니아의 바이오서비스 역량 확충은 2027년에 실질적으로 완료될 것으로 예상된다.

향후 상업화 출시에 대해 경영진은 길리어드(Gilead)가 보유한 아셀릭스 치료제와 자가면역질환 부문 최초의 승인 세포·유전자 치료제가 될 수 있는 2027년 초 승인 가능성을 강조했다. 다만 경영진은 구체적인 추가 매출 추정치는 제시하지 않았다.

임상 3상 프로그램의 증가는 업계 자금 조달 여건 개선, 풍부한 자원을 갖춘 대기업 중심의 통합, 소형 바이오테크 기업들이 상업적 잠재력이 더 명확한 프로그램에 우선순위를 부여한 데 기인한 것으로 풀이됐다.

크라이오진(CryoGene)의 새로운 초저온 기술 서비스(Cryogenic Technical Services)는 고객 수요에 대응한 조치로 설명됐다. 경영진은 이 서비스가 크라이오진의 휴스턴, 샌안토니오 사업장 및 향후 예정된 탬파 사업장과 함께 시간이 지남에 따라 추가 매출에 기여할 것으로 기대하고 있다.

실적 발표 컨퍼런스 콜 전문

전체 실적 발표 컨퍼런스 콜 녹취록

경영진 발표

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.

질의응답

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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