스테바나토 그룹(STVN) 2026년 3분기 실적 발표 콜: BDS 성장이 GLP-1 역풍 상쇄

핵심 요약

• 2026년 3분기 매출은 보고 기준 및 자체 성장(organic) 기준 모두 전년 동기 대비 8% 증가한 3억 2,610만 유로를 기록했습니다. 바이오제약 및 진단 솔루션(BDS) 부문의 11% 자체 성장이 엔지니어링 부문의 12% 감소를 상쇄했습니다.
• 조정 EBITDA는 14% 증가한 8,880만 유로를 기록했으며, 조정 EBITDA 마진은 150bp 확대된 27.2%를 나타냈습니다. 조정 순이익은 14% 증가한 4,400만 유로를 기록했습니다.
• GLP-1 관련 매출은 감소하여 전체 매출의 약 17%~18%를 차지했습니다. 비GLP 바이오의약품 매출은 3분기에 30% 이상 성장했으며, 연초 대비(YTD) 13% 증가했습니다.
• 경영진은 매출 12억 6,000만~12억 8,000만 유로, 조정 희석 EPS 0.60~0.62유로를 포함한 2026 회계연도 연간 연결 실적 전망(가이던스)을 재확인했습니다.
• 단일 고객사의 예상 GLP-1 물량 감소로 인해 2027년 성장이 일시적으로 둔화될 것으로 예상됩니다. 그럼에도 경영진은 비GLP 바이오의약품 성장과 생산능력 대체(backfilling)에 힘입어 한 자릿수 초반의 매출 성장을 유지할 것으로 전망하고 있습니다.
• 피셔스(Fishers) 공장은 3분기에 매출총이익 손익분기점에 도달했으며, 이탈리아에서는 첫 번째 대량 생산용 알바(Alba) 주사기 라인 인증이 완료되었습니다. 경영진은 2027년에도 마진과 순현금흐름(free cash flow) 개선세가 지속될 것으로 예상합니다.

주요 재무 데이터

사업 및 운영 실적

BDS 부문은 보고 기준 10%, 자체 성장 기준 11% 증가한 2억 9,400만 유로의 매출을 기록했습니다. 고가치 솔루션은 부문 매출의 약 51%를 차지했습니다. 부문 매출총이익률은 10bp 상승한 32.1%를 기록했으며, 영업이익률은 90bp 상승한 23%를 기록했습니다.

기타 용기 보관 및 투여 솔루션 매출은 보고 기준 22%, 자체 성장 기준 23% 증가한 1억 4,460만 유로를 기록했습니다. 이러한 성장은 표준 주사기 및 카트리지, 벌크 카트리지, 약물 투여 시스템 위탁생산(CMO)의 초기 호조에 따른 것입니다. 해당 부문에는 GLP-1 물량 감소와 관련된 변동 보상도 포함되었으나, 경영진은 이것이 매출 대비 유의미한 수준은 아니라고 밝혔습니다.

엔지니어링 부문은 제약용 육안 검사, 조립 및 포장 부문의 매출 감소로 인해 12% 줄어든 3,200만 유로의 매출을 발표했습니다. 매출총이익률은 20bp 하락한 10.2%를 기록했습니다. 다만 비용 최적화 노력에 힘입어 영업이익률은 220bp 상승한 1.1%를 기록했습니다.

경영진은 GLP-1 매출이 주로 주요 오리지널 개발사들의 상업화 제품에 연동되어 있다고 설명했습니다. 또한 회사는 EZ-fill 및 자체 투여 디바이스 등의 제품을 활용하여 다양한 개발 단계에 있는 50개 이상의 GLP 관련 프로그램에서 30개 이상의 고객사와 협력하고 있습니다.

스테바나토 그룹은 폼비노 데세(Piombino Dese) 공장에서 첫 번째 대량 생산용 알바(Alba) 주사기 라인의 인증을 완료했습니다. EZ-fill 카트리지 생산은 전면 가동 상태를 유지했으며, EZ-fill 바이알 생산량은 확대되고 있습니다. 경영진은 즉시 사용 가능한(ready-to-use) 카트리지가 2027년 대부분 기간 동안 완판 예약 상태라고 덧붙였습니다.

피셔스 공장은 매출총이익 손익분기점에 도달했으며, 상업용 EZ-fill 바이알의 첫 주문 물량을 출하했습니다. 디바이스 제조용 클린룸 구축이 완료됨에 따라 향후 수개월 내 상업용 디바이스 물량 생산이 시작될 것으로 예상됩니다. 경영진은 피셔스 공장이 2028년 말까지 완전 가동(full ramp-up)에 도달한다는 목표를 순조롭게 진행 중이라고 밝혔습니다.

라티나(Latina) 공장에서는 고객사 감사 및 검증과 더불어 EZ-fill 주사기 생산이 지속되었습니다. 다음 증설 단계는 EZ-fill 즉시 사용형 카트리지에 집중될 예정이며, RTU 400 카트리지 매출은 2027년부터 발생할 것으로 예상됩니다.

경영진 가이던스

스테바나토 그룹은 다음과 같이 2026 회계연도 가이던스를 재확인했습니다.

경영진은 현재 2026 회계연도 가이던스 중간값 기준으로 BDS 부문의 자체 성장률이 두 자릿수를 기록할 것으로 예상하고 있습니다. 이는 부진한 엔지니어링 매출을 상쇄하여 전체 연결 가이던스를 유지하는 데 기여할 것으로 기대됩니다.

회사는 고가치 솔루션이 2026 회계연도 매출의 47%~48%를 차지할 것이라는 기존 전망을 유지했으며, 이는 4분기 비중이 거의 50%에 달함을 의미합니다. 경영진은 넥사(Nexa) 주사기, EZ-fill 바이알 및 카트리지를 주된 성장 동력으로 꼽았습니다.

2027년에 대해 경영진은 한 자릿수 초반의 매출 성장을 예상하고 있습니다. 특정 GLP-1 고객사의 넥사 주사기 물량 감소가 주된 악재가 될 것으로 예상되며, 지연된 엔지니어링 주문 또한 동일한 고객사와 연결되어 있습니다. 회사는 영향받은 생산능력의 대부분을 이미 대체했다고 밝혔으나, 고객사 검증 및 프로그램 일정상 완전한 대치에는 추가적인 분기가 소요될 예정입니다.

경영진은 2027년에도 고가치 솔루션의 성장이 지속되고, 마진이 확대되며, 잉여현금흐름이 플러스 상태를 유지할 것으로 예상합니다. 2027년 이후에는 장기 매출 성장 목표인 한 자릿수 후반에서 두 자릿수 초반 수준으로 회복하고, 조정 EBITDA 마진 목표를 29%~30%로 설정하고 있습니다.

리스크 및 주시 사항

• 단일 고객사 사정으로 인해 2027년 예상 GLP-1 물량이 기존 기대치보다 감소하여 넥사 주사기 및 관련 엔지니어링 주문에 영향을 미치고 있습니다.
• 고객사의 자격 인증 및 검증 일정으로 인해 GLP-1 관련 생산능력의 완전한 대체가 지연될 수 있습니다.
• 엔지니어링 부문의 3분기 신규 수주액은 목표를 하회했으며, 파이프라인 프로젝트가 최종 수주 계약으로 전환되는 데 예상보다 많은 시간이 소요되고 있습니다.
• 유럽의 가스 및 에너지 가격 상승이 3분기 매출총이익률을 압박했습니다. 경영진은 가이던스에 반영된 바와 같이 4분기 유틸리티 가격이 3분기 수준을 소폭 상회할 것으로 보수적으로 가정하고 있습니다.
• 생산능력 투자와 관련된 감가상각비 증가 또한 매출총이익률에 부담으로 작용했습니다.
• 엔지니어링 부문의 육안 검사 및 조립 사업은 여전히 연결 마진을 희석시키고 있습니다. 경영진은 해당 사업에 대한 최선의 전략적 접근 방안을 지속 검토 중이라고 밝혔습니다.

애널리스트 Q&A 주요 내용

경영진은 2027년 GLP-1 관련 악재가 단일 고객사에 국한된 것임을 확인하였으며, 이것이 시장 점유율 손실을 의미하는 것은 아니라고 설명했습니다. 회사는 이 문제를 일시적인 것으로 규정하고, 장기 고객 관계에는 무조건 지급 계약(take-or-pay), 최소 물량 보장, 생산능력 예약, 자본적 지출 분담, 시장 점유율 보장 등의 보호 조치가 포함될 수 있다고 덧붙였습니다.

영향을 받은 생산능력은 주로 넥사 주사기 부문입니다. 스테바나토 그룹은 복수의 고객사를 통해 상당 부분의 물량을 대체했다고 밝혔으나, 이 과정을 완수하기 위해서는 2027년까지 추가적인 검증과 시간이 필요할 것입니다. 경영진은 이러한 악재가 없었다면 2027년 성장이 장기 목표치인 한 자릿수 후반에서 두 자릿수 초반에 부합했을 것이라고 언급했습니다.

비GLP 바이오의약품 부문과 관련하여 경영진은 알바 주사기, 즉시 사용형 카트리지, EZ-fill 바이알 및 자체 투여 디바이스 전반에 걸친 견조한 수요를 강조했습니다. 알리나(Alina), 에이댑터스(Aidaptus), 데오라(Deora) 등은 바이오시밀러, 대사 질환, 내분비학, 면역학, 심혈관 질환을 포함한 바이오의약품 적용 가능성을 평가받고 있습니다.

또한 경영진은 엔지니어링 사업이 공급망, 프로젝트 관리, 기술 실행 등 운영 측면에서 진전을 이루었다고 설명했습니다. 주요 문제는 운영상의 악화가 아니라 파이프라인의 확정 수주 전환 속도가 더디다는 점입니다.

실적 발표 전화회의(콜) 전문 기록

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전체 실적 발표 컨퍼런스 콜 녹취록

경영진 발표

Operator

Good afternoon. This is the Chorus Call conference operator. Welcome, and thank you for joining the Stevanato Group Third Quarter Financial Results Conference Call. [Operator Instructions]

At this time, I would like to turn the conference over to Ms. Lisa Miles, Chief Communications and IR Officer. Please go ahead, Madam.

Lisa Miles

Good morning, and thank you for joining us. With me today is Franco Stevanato, Chairman and Chief Executive Officer; and Marco Dal Lago, Chief Financial Officer.

We have posted a presentation to accompany today's results on the Investor Relations page of our website, which can be located under the financial results tab.

I want to remind everyone that some statements being made today are forward-looking and based on current expectations. Actual results may differ materially due to risks outlined in Item 3D, Risk Factors, of our most recent Annual Report on Form 20-F filed with the SEC.

Please review the safe harbor statement included at the beginning of today's presentation and in our press release. The company undertakes no obligation to revise or update these forward-looking statements, except as required by law.

Today's presentation may include non-GAAP financial information. Management uses these measures internally to assess performance and believes they may be helpful for investors in evaluating the quality of our financial results, identifying trends in our performance, and providing meaningful period-to-period comparisons.

Please note that for today's call, we are introducing a new non-GAAP measure, organic revenue, for the purpose of offering a proper year-on-year comparison. Organic revenue is defined as reported revenue excluding the effects of divestments and/or acquisitions, and the impacts of foreign currency translation. For a reconciliation of these non-GAAP measures, please refer to the company's most recent earnings press release.

And with that, I will now hand the call over to Franco Stevanato.

Franco Stevanato

Thank you for joining us. Today, we'll review our third quarter performance, share an update on market trends, and discuss the current market environment.

Our third quarter financial results were in line with our expectations. Reported and organic revenue grew 8%, high-value solutions represented 46% of total revenue, and adjusted EBITDA increased 150 basis points to 27.2%, compared to the third quarter of 2025.

Revenue growth was driven by an 11% increase, on an organic basis, in the Biopharmaceutical and Diagnostic Solutions Segment, which offset a 12% decline in the Engineering Segment. Revenue related to GLP-1s decreased in the third quarter and was approximately 17% to 18% of the total company revenue.

Revenue from non-GLP biologics increased over 30% in the quarter, offsetting the decline from GLP-1s. And on a year-to-date basis, revenue from non-GLP biologics was up 13%, demonstrating once again the diversity of the broader demand landscape.

In the second and third quarters of fiscal 2026, we recorded variable compensation in the BDS segment tied to lower volumes, mostly related to GLP-1 therapies.

Turning to next year, we are working through the binding forecast process with our customers. Forecasts are consistent with the trends we experienced thus far in 2026, with increasing demand across our high-value portfolio from most of our customers.

However, within our GLP portfolio, we now expect lower volumes than previously anticipated for 2027. This was not entirely unexpected, and we started taking action several months ago to offset this impact. For example, the flexibility of our global operations allowed us to move some capacity to different regions to accommodate higher demand from other customers.

More importantly, we currently expect consistent strong demand in non-GLP biologics in 2027. We are still in the process of finalizing customer production forecasts for next year, and we are confident that we have already backfilled the majority of this revenue. But we now expect this will result in a temporary moderation of growth in fiscal 2027.

Looking ahead, GLPs remain a phenomenal drug class, and we expect to continue to benefit in the long term. Currently our GLP revenue is predominantly tied to commercial products from the main originators.

However, we are actively working with over 30 global customers for multiple programs in various stages of clinical development. These new customer programs are expected to play an important role in future growth, and they utilize high-value products, including our EZ-fill platform and proprietary delivery devices.

Today, the global patient penetration is well below 10%, and the opportunity remains significant and largely untapped. The overall demand environment for injectable biologics remains structurally strong, underpinned by long-term durable tailwinds.

Scientific innovation is driving global pipelines with novel therapies expanding patients' reach. Moreover, technology advancements are providing breakthrough solutions that enhance patients' convenience and adherence. New formulation and delivery technologies allow for self-injection of highly viscous and higher volume drugs.

This is critical as treatments delivered intravenously in a hospital setting transition to a subcutaneous presentation that can be administered by patients at home. This offers clear advantages for patients and in reducing healthcare costs.

Lastly, we continue to see growing demand for high-performing containment and off-the-shelf delivery systems to support the large wave of biosimilars approaching the market in the coming years. Beyond GLPs, our customers are building a wide biosimilar pipeline including assets in immunology, oncology, endocrinology, and other therapeutic areas, that will expand patient access globally and represent a very attractive opportunity for us in the medium and long term.

In response to these market trends, we are squarely focused on meeting customer needs with new technology, innovation, and additional production capacity.

Our Alba syringe platform is a great example of this innovation. It is our highest performing syringe platform and has unique features that have led to growing market demand. In recent weeks we qualified our first high-volume Alba syringe line, in our Piombino Dese plant.

Customer demand also remains solid across other EZ-fill platforms. We continue to run production of our EZ-fill cartridges at full utilization, and we are progressively increasing production for EZ-fill vials, as demand continues to expand to a larger set of customers.

Moving to Delivery Devices, the opportunity pipeline for our proprietary platform continues to grow. Our Alina, Aidaptus and Deora platforms are in various stages of evaluation for a diverse range of biologic applications, mainly biosimilars, including GLPs and metabolic diseases, endocrinology, immunology, cardiovascular diseases, and other therapeutic areas.

Our customers' needs are clear, pointing at solutions that enhance patient usability and adherence, derisk supply chain, provide a better answer to new drug product requirements of modern formulations, and, lastly, increase the sustainability and efficiency profile of combination products.

We believe we have the right set of products, expertise, and competencies to support our customers with a broad and unique value proposition.

Let's turn to the Engineering Segment. The operations have stabilized, and efforts under our optimization plan have created operational improvements, but financial results in the third quarter were below our expectations.

We made good progress with new order intake last quarter, but we ended the third quarter below our target levels of signed new orders. This was due in part to a number of orders that have been delayed from a large customer, which put pressure on the segment in 2026.

Our guidance now reflects a slight adjustment to our full year 2026 revenue expectations for the Engineering Segment. This is expected to be fully offset by better performance in the BDS Segment and has no impact on consolidated guidance. Marco will provide more details.

Let's review the progress of our growth initiatives in U.S. and in Italy. During the third quarter, we continued to scale these investments with discipline, further enhancing operational maturity and increasing capacity to support customer demand. In Latina, commercial operations for EZ-fill syringes are running smoothly, and we continue working on customer audit and validation activities.

Looking ahead, the team is busy preparing the facility for the next phase of expansion, which is dedicated to EZ-fill ready-to-use cartridges. Demand for high-value cartridges remains strong, with the market expanding beyond the traditional cartridge players.

Our new RTU 400 cartridge lines are the first of their kind, driving significant innovation and production capacity. This includes a new aseptic crimping process to ensure sterility at the cartridge interface and maintain closure integrity in aseptic conditions.

This is one of the most distinctive features and a key enabler for protecting the final product throughout the sterile packaging flow. With new production of EZ-fill cartridges in Latina, customers now have greater supply chain security, while at the same time it gives us greater operational flexibility.

Moving to Fishers, I'm pleased to report that the site broke-even at the gross profit margin level in the third quarter, achieving another important milestone as we scale this multiyear investment. More recently, we shipped the first commercial EZ-fill vial order, while customer audit and validations continue, alongside ongoing line installations.

During the third quarter, we completed the buildout of the device manufacturing cleanroom. We remain on track to launch commercial volumes in the next couple of months. We are in the early phase of commercialization for our device programs. Over the next 18 months our facilities in Fishers and in Germany will be focused on a significant commercial scale-up for contract manufacturing and our proprietary Alina pen injector.

In summary, the overall demand environment for injectable biologics remains solid, driven by strong secular tailwinds such as aging population, scientific innovation, and the rising trend of self-administration of medicine. We have positioned the business in the most attractive areas of the market that require high-performance products.

Our broad product portfolio addresses these needs from our groundbreaking Alba syringe platform to our large-volume cartridges and our integrated drug delivery systems such as our Alina pen. Robust market demand in biologics and biosimilars gives us the confidence that we can backfill the lower GLP revenue and still grow low single digits in 2027.

I'll turn the call over to Marco for a review of our third quarter financials.

Marco Dal Lago

Thanks, Franco. Before I begin, I'd like to clarify that all comparisons refer to the third quarter of 2025. Let's start on Page 10.

In the third quarter of 2026, revenue grew 8% to EUR 326.1 million, both on a reported basis and organically. This was driven by 11% organic growth in the BDS Segment, which offset a 12% revenue decline in the Engineering Segment.

Revenue from high-value solutions increased 1% to EUR 149.4 million, both on a reported basis and organically, and accounted for 46% of total revenue.

In the third quarter of 2026, gross profit margin decreased 10 basis points to 29.1%, and was unfavorably impacted by increased utility costs, the expected higher depreciation, and lower gross profit in the Engineering Segment. This was partially offset by the combined improvements in Latina and Fishers, and a better mix compared to last year.

Operating profit margin increased 110 basis points to 18.5% and adjusted operating profit margin increased 90 basis points to 19.4% in the third quarter of 2026. Net profit grew 16% in the third quarter and amounted to EUR 41.8 million, and diluted earnings per share were EUR 0.15.

On an adjusted basis, net profit increased 14% to EUR 44 million and adjusted diluted EPS increased to EUR 0.16. Adjusted EBITDA grew 14% to EUR 88.8 million and adjusted EBITDA margin increased 150 basis points to 27.2% in the third quarter of 2026.

Moving to segment results on Page 11. In the third quarter of 2026, revenue from the BDS Segment was EUR 294 million, which grew 10% and increased 11% on an organic basis. Revenue from high-value solutions was EUR 149.4 million, increasing 1% both on an organic and reported basis, driven by EZ-fill syringes and cartridges and represented approximately 51% of segment revenue.

Revenue from other containment and delivery solutions was EUR 144.6 million, which grew 22% and increased 23% on an organic basis, driven by growth in standard syringes and cartridges, and included variable compensation tied to GLP therapies.

In the third quarter of 2026, gross profit increased by EUR 8.9 million, and gross profit margin grew 10 basis points to 32.1%. This was driven by higher revenue, the combined improvements in Fishers and Latina, and a better mix, which was offset by higher utilities and depreciation costs. Operating profit margin grew 90 basis points to 23%.

In the third quarter of 2026, revenue from the Engineering Segment decreased 12% to EUR 32 million, primarily due to lower sales in pharma visual inspection, and assembly and packaging, which offset growth in aftersales activities. In the third quarter of 2026, gross profit margin decreased 20 basis points to 10.2%, due to lower revenue, the timing of order intake, and project execution. Cost optimization initiatives helped to improve operating profit margin by 220 basis points to 1.1%.

Please turn to the next slide for a review of our balance sheet and cash flow. We ended the quarter with cash and cash equivalents of EUR 114.9 million and net debt of EUR 353.7 million. We believe we have adequate liquidity to fund our strategic priorities through a combination of cash on hand, available credit lines, cash generated from operations, and the ability to access additional financing.

For the third quarter of 2026, capital expenditures totaled EUR 44.8 million, mostly related to growth investments in the new plants, and for our device programs in Germany.

In the third quarter of 2026, net cash from operating activities totaled EUR 57.6 million. Cash used in property, plant, and equipment, and intangible assets was EUR 36.3 million. In the third quarter of 2026, the company generated free cash flow of EUR 21.7 million.

Please turn to the next page. We are reiterating our full year guidance and still expect revenue in the range of EUR 1.260 billion to EUR 1.280 billion, adjusted EBITDA between EUR 335 million and EUR 345.2 million, and adjusted diluted EPS is still expected to range between EUR 0.60 and EUR 0.62 for the fiscal year.

We are updating a couple of assumptions in our full year guidance. For fiscal 2026, we now anticipate stronger growth from the BDS Segment, now growing organically double digits at the center point of the guidance. This is expected to fully offset the slight revenue decline in the Engineering Segment compared with our prior guidance.

Revenue from the Engineering Segment is now expected to range between EUR 124 million and EUR 134 million. And finally, we now assume that CapEx will range between EUR 230 million and EUR 240 million and net of customer contribution, EUR 215 million to EUR 225 million.

I will now hand the call back to Franco for closing remarks.

Franco Stevanato

In closing, in the third quarter we delivered another solid performance in line with our expectations, and we remain on track for the full year 2026 objectives. We expect that GLP will continue to be a very good tailwind for us.

In the short term, the adjustments to anticipated GLP-1 volume will temporarily moderate growth in 2027. Based on what we know today, we believe we can still grow low single digits in 2027 driven by favorable secular trends across the broader biologics area.

Without this temporary headwind in 2027, we believe that we would have grown in line with our long-range plan of high single digits to low double digits. We expect that our main KPIs will continue to move in the right direction. This includes continued growth in high-value solutions, expanding margins, and positive free cash flow for next year.

Over the medium- to long-term, GLPs will continue to drive favorable demand with new assets coming to market, the ongoing expansion of indications, and upcoming patent cliffs and new biosimilar launches. We have a long history of serving pharma and biotech customers, and this is the natural evolution of any new therapeutic class.

As we look beyond 2027, we expect to return to more normalized growth in 2028 underpinned by the strength of the broader biologics market. The demand for injectable biologics remains strong, with more than 9,000 injectable assets in the global drug pipeline.

These are in advanced stages undergoing clinical evaluation or registration. And more than 60% of those are biologics. Our strategy is firmly anchored in the higher-valued subsets of the market, and the business is positioned as a leader in biologic applications. Our strategy is unchanged, and we are progressing against our objectives.

Operator, we are ready for questions.

Operator

This is the Chorus Call operator. [Operator Instructions] First question is from David Windley, Jefferies.

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David Windley

I wanted to try to first clarify on the variable compensation and then ask a follow-up. So on the variable compensation, am I understanding correctly that, that's essentially a take-or-pay payment that the client is not using the committed volume and so you're getting consideration in lieu of that?

If you can quantify that, I'd love to hear the number. And then as you think about -- this is a follow-up. As you think about pursuing non-GLP-1 volumes to backfill that, are those opportunities the same formats and the same products as what you would have been producing for your GLP-1 clients?

Marco Dal Lago

So Marco speaking, I'll start from the variable compensation. We cannot disclose the specific clause we have with each single customer and contract. However, what I can tell you that in this case is related to lower volumes, and so the contractual protection we have in place, and basically, we are in line with what we said before.

We have several contractual protection depending customer by customer, can be take-or-pay, minimum quantities, capacity reservation, CapEx contribution or market share protection. In this case, in 2026 is related to lower volumes compared with the committed binding forecast. We cannot quantify for the reason I mentioned before. What I can tell you is that it is not relevant in the quarter in the year.

Franco Stevanato

Franco speaking. Today, this reduction of this temporary demand is linked to particular to syringes, [indiscernible] syringes, we already start to backfill this temporary headwind with our strong demand that we have, in particular on the biologic and injection space.

So today, we are really starting to do a good job in order to backfill most of this temporary headwind we already started to backfill. On the top of this, what I would like to add that more on the broader aspect of the biologic market, the demand is strong.

And today, we have also a strong demand on Alba, where we are adding capacity in Italy. We have strong demand on cartridges to fill both biologic and also in the GLP-1 because we are starting to ramp up our capacity for drug delivery system. So we have done a good job in order to backfill this capacity in order to maintain a low single digit in 2027 despite this temporary headwind.

David Windley

Great. If I could ask one more clarification. In the statement that the variable compensation is not material to the quarter, I think you also are highlighting that you're taking some amount in the third quarter related to the second quarter.

So I guess both of those are relatively small. Is the size of those small because the relative shortfall was small? Or is that more a result of where the protections kick in? Because it looks like your GLP-1 production in the quarter was materially below what you would have expected.

Marco Dal Lago

Again, I need to reiterate what I told you before. We cannot disclose the details about the clauses we have in each single contract. We have protection in place and in agreement with the customer, we started to recognize the amount in our P&L is we are growing in the BDS Segment as expected.

We are growing 12.2% organically in the 9 months. And for our long-term contract, we have protection in place that, in this case, is not significant with respect to our revenue.

Operator

Next question is from Avantika Dhabaria, Bank of America.

Avantika Dhabaria

And then just to clarify on the GLP-1 headwind, can you give us some more color on whether it's concentrated in a single customer or more widespread? And then I have a follow-up.

Franco Stevanato

Yes, I confirm that this temporary headwind in 2027, it is tied to one customer.

Avantika Dhabaria

Got it. And then on the non-GLP-1 biologics growth in 3Q, can you give us some color on what was the primary driver for the strong -- was it strong volumes or existing programs? And how should we think about this growth going into 2027?

Franco Stevanato

Yes. Thank you for the question. Today, Stevanato Group is extremely active in the biologics space. Biologics space is where there are many thousands of new molecules. We are talking about approximately 9,000 molecules that are in Phase II and Phase III in different therapeutic classes.

We're talking about monoclonal antibody, biosimilar, mRNA application, wide range of biosimilar for multiple therapeutic areas like immunology, inflammatory, rare disease, oncology. And Stevanato is actually working with several customers on a worldwide basis in order to validate our Alba technology where we are investing capacity in Italy.

We have a huge portfolio of new program on cartridges ready to fit a different format where we are heavily investing capacity in [indiscernible] and into Latina. Also we have a big program in order to ramp up capacity for our drug delivery strategy through our Alina program in Germany and with our drug deliveries that we are building up in our plant in Fishers.

Overall, with this program that we have, we are able to backfill this temporary headwind that we are facing 2027. And despite this single customer, we will be able to be low single digit in 2027. And even more, we are confident that beyond 2027, we will normalize and we go back to our normalized growth.

Operator

Next question is from Anna Snopkowski, KeyBanc.

Anna Snopkowski

This is Anna Snopkowski on for Paul Knight. I have 2, but maybe to start on your device portfolio. You mentioned you're going to launch commercial volumes for the Alina pen in the coming months. Do you think you could just remind us whether you support any commercial therapies today and what your pipeline looks like? And then maybe just your long-term view on the growth for delivery devices? And then I have one follow-up.

Franco Stevanato

Franco speaking. Yes, I'm confirming that we have received certain number of validation and registration in the first 6 months to our Alina program, our IP product that we are going to produce in Germany, and we are ramping up capacity even more in the next years to come.

We are waiting for other registration validation in the second part of the year, and we are directly engaged with a multiple number of customers and biosimilar customers in our liraglutide program, the other biologic application.

So today is one of our strategy in Stevanato Group to not only serve our EZ platform, also provide our device program with priority #1 to our IP where we are going to produce in our plant in Germany, and this will represent an incremental revenue generation in the next years to come.

And also in parallel, we are working in a selective way to certain big international customer to work in a sort of CMO business model. We have active program that we will provide to our plant in Germany, even more in our plant in Fishers, we are ramping up a big department production for our big U.S. client.

Anna Snopkowski

Great. And then maybe just a follow-up. Looking at 2027 growth, could you just walk us through your assumptions for the different segments as well as GLP-1 growth? And are you assuming another year of declines on the engineering side?

Marco Dal Lago

Maybe I'll start with some color about 2027. It's a little bit early. We will provide full guidance in the next earnings call beginning of March. However, what I can tell you is that visibility remains strong despite the lower-than-anticipated forecast from GLP we mentioned.

We already launched action to backfill the capacity for 2027 that is mainly related to Nexa syringes. And overall, the demand across injectable biologics is strong. And today, we are confident we will be able to cover most.

As mentioned, year-to-date, we grew 13% in non-GLP-1 biologics, giving us the confidence that we can backfill the GLP-1 customer temporary weakness. In particular, we see great traction on Alba.

We recently launched the Alba industrial line following the strong demand we can see and the growth we had in third quarter. We mentioned many times that for RTU cartridges, we are fully booked for most of 2027.

For Nexa, as mentioned, we started backfilling, being able to backfill most of the capacity for 2027. And last but not least, you mentioned before that we are gaining traction with more and more visibility, our Alina pen that is growing significantly compared with the current volume. So our portfolio demonstrates that is strong, and we can leverage strong demand and visibility into the market.

Franco Stevanato

If I can add a little bit more color, in particular, in the BDS Segment in this year, also last year, we were able to deliver double-digit growth because like Marco said, biologic market demand is robust, and we have a strong traction with our high-value product platform.

Also, if you can go back also to our GLP, GLP-1 is a phenomenal drug class, and this will continue to grow in the next years to come. Today, if you look a little bit at the level of penetration, we are below 10% of the full worldwide patient penetration.

And besides the 2 big originator, there is a lot of new customers coming onboard. In Stevanato Group, we are active with more than 30 customers with more than 50 programs through most of our high-value products.

So the message is that we are now facing a temporary headwind in 2027 that is going to adjust our growth based on our strategy. But if you look more the medium-term trajectory Stevanato Group, we are optimistic and confident that we are going in the good direction in improving revenue and also margin and the generation of cash.

Operator

Next question is from Chad Wiatrowski, TD Cowen.

Chad Wiatrowski

It looks like Annex 1, the European regulation is contributing a couple of hundred basis points to the market broadly in containment and components. So curious if you're seeing that, if there's any way you could help us quantify the tailwind? Is that helping in 2027?

And then similar to that question, I guess, are you seeing the trend happen in U.S. as well? And is that a similar-sized market opportunity for you?

Franco Stevanato

Yes. Today, we -- this one that we're starting to monitor carefully since 2 years, we see that it's going to give benefit to Stevanato to convince pharmaceutical customers to move into the EZ-fill direction instead to continue to use bulk technology.

I make an example on cartridges ready-to-fill, historically, the cartridges was primarily spread across very few customers only into insulin and anesthetic. Today, we see that this market demand is extended with a wide range of customers and different therapeutic classes in biologics from [indiscernible].

So we see that the adoption of EZ-fill technology, in particular for cartridges into buyer, is helping to boost our growth in this product category. Another example that we see that already some existing customers that have commercial product in bulk cartridges, they have decided to convert into ready-to-fill cartridges. So we see that this will help to boost, increase our revenue in the future around our EZ-fill product, in particular, cartridges and buyer.

Chad Wiatrowski

And then just on that one GLP-1 customer, is this like a change in format? Is this going to 0 for them? Or is this more of like oversupply and working down inventory? Can you just give a little bit more color on kind of the dynamics there without obviously disclosing the partner?

Franco Stevanato

So we cannot disclose information about our customer. What we can see that is a temporary headwind that we are facing is that we have to say that the GLP-1 is at the beginning, and it's quite common at the beginning of this launch of the product in the market that can have some temporary fluctuation. This is a traditional historical customer is a market leader. I think that we are not concerned at all. We consider more a temporary headwind in 2027, nonaffected long-term range.

Operator

Next question is from Larry Solow, CJS Securities.

Lawrence Solow

Just a follow-up on that -- following up on that question. So what gives you the confidence, I know it's hard to answer, but it's a temporary headwind? I know you can't -- hard to give us any real color, but it doesn't sound like you've lost any share or anything with this customer.

It sounds like the customer -- it's customer-specific issues. What gives you that confidence that they're going to reinvigorate their demand or their growth? It feels like it's just perhaps your alignment with -- you may not be on the lead -- there are 2 horses in this race, clearly, right?

And perhaps your proportion is more on horse #2 than horse #1. I mean, that sounds like that's clearly the issue. I mean, I don't know if you can confirm that, but am I in the right direction there?

Franco Stevanato

So first of all, it's difficult for us because we cannot enter in the confidentiality of the contract we have with our customers. Usually with our big international customers in general, we are protected with a long-term contract.

We are covered by different agreements that can be by quantity, CapEx contribution, take-or-pay formula, market share, or certain binding product that we agree. So the nature of the partnership that we have enhance us to have a very clear and transparent relationship that is the nature of what Stevanato is doing since more than 20 to 30 years.

So we are not concerned that is that we are losing market share at all. Even more it's the opposite. We see that Stevanato Group is playing an active role in this GLP-1 opportunity in the next years to come because we are spread into the originator.

And also we are active working in the medium-term with tens of programs like I mentioned to you, we have more than 30 active customers with more than 50 programs. And this is one of the reasons why we have really done a very good job inside the organization to backfill this temporary headwind that we are going to face only in 2027.

Lawrence Solow

That's fair. So it sounds like it's -- you're not losing share, but perhaps your customer has lost share. I'll leave it at that, I guess. I guess just a follow-up, how does -- you still had a pretty good quarter this quarter, actually, your revenue was really strong. You mentioned a little lower GLP.

You're not lowering the guidance for this year. Just as you look out to next year, I know you're not ready to break out GLP versus non-GLP-1 sales, but is it -- are you seeing an acceleration on the non-GLP-1 side?

Franco Stevanato

Like already Marco mentioned before, today, we're happy about this solid quarter 3 that we are delivering. We are on track to achieve our 2026 objective. And even more, if you look at the pipeline that we have in biologics and the trend that we have in biologics, we have delivered plus 30% this quarter compared to last quarter.

And on the year-to-date basis, we have plus 13%. But it's the nature of the program that we have behind. We have many programs well spread, equally spread between Alba technology, cartridges to fill, buyer to fill drug delivery system. So all this combination of elements are going directly in the direction of the investment that we are doing in Italy, in Germany, in Fishers.

We say this is why we're confident that we will be able to backfill 2027 to be -- to deliver another growth in 2027, more softer, that was our expectation. But even more what is important, the sentiment that I want to pass to all of you that our trajectory in the medium term is intact because of the quantity of the program where Stevanato is engaged in biologic and also in GLP-1.

Lawrence Solow

Okay. Great. I appreciate that color. Just if I could squeeze one last one in. Great to see Fishers get to breakeven this quarter on a gross profit level. The slowdown in GLPs, at least temporarily, does that kind of slow or maybe push out a little bit the ramp partly in Fishers towards profitability?

Franco Stevanato

This program of Fishers is on track. Our program is to be full up and running at the end of 2028 with our capacity expansion on syringes. We plan to add capacity for buy rate to fit because that we are starting to do the first commercial revenue in this quarter.

We will add also Alba technology even more, we are starting now to ramp up our gig department for the device that will start to generate commercial revenue in 2027. Everything is on track and the demand is robust.

Operator

Next question is from Mac Etoch, Stephens.

Steven Etoch

Maybe just a couple for me. And following up on Anna's question earlier, I'd love to just get a sense of what's going on within the underlying engineering order trends, just to kind of put a finer point on the trends that you're seeing there?

Franco Stevanato

So on the engineering, like I mentioned, we -- the team is making a good operational progress, like I already mentioned in the several quarters, what we are doing in terms of supply chain, project management, and technical department, we are going to do a good job.

In the meantime, we're building a strong pipeline of new program. What we are facing and we are struggling is the delay into the conversion in orders. In fact, this is the reason why in this quarter, we were lower compared with our expectation.

This was due also in part of the delay of orders from a key customer that has also lowered the volume. They also have create some pressure in the 2026 and also we do in 2027. So all overall, from operational point of view, we are fine, we are on track.

Where we are struggling today is the conversion of the pipeline into orders. This is the reason why we have decided to review together with Marco the guidance for the outlook for 2026, and we are much more compensated with the BDS Segment.

Steven Etoch

Got it. And just to clarify, it sounds like outside of that single customer, things are kind of progressing as expected, it's just more of a 2027 outlook at this point?

Franco Stevanato

So we -- like I mentioned, from operational point of view, between our 2 plants in Italy, in Bado and Bologna, the plant in Danmar, we have achieved a meaningful operational improvement. The pipeline we have built with our sales organization is good.

Where we are facing some delay is conversion into orders. This is the reason why for what is related to 2027, despite also this new slowdown with one customer is that we are also optimistic that we at certain point this pipeline will translate in orders.

But from the moment that we have the okay from the customer to go with Stevanato, we see because of the technicality, we talk about particular inspection machine or assembly machine, sometimes it takes months to define the specification and to sign the order. This is where we are struggling in this moment.

Operator

Next question is from Doug Schenkel, UBS.

Douglas Schenkel

Just 2 cleanups. With high-value solutions growing 1% and accounting for about 46% of Q3 sales, should we still be modeling mix of 47% to 48% for the year? And if so which products or customer programs are going to drive that implied Q4 step-up?

So that's the first one. Second one is on backfilling most of the GLP-1 shortfall. If you've done that already or you're on a path to do that, why is next year's growth target still below your longer-term outlook? I'm just trying to get at how firm is the replacement revenue? And I guess by extension, how do those programs compare from a timing, visibility and profitability standpoint?

Marco Dal Lago

Thanks for the question, Doug. I'll start with high-value solutions. Yes, we reiterate our guidance from 47% to 48% as a percentage of revenue. It is normal for us in some quarterly fluctuations in the mix in high-value products.

You are giving me the opportunity to clarify that we refer to better mix because we are gaining a lot of traction in products like Alba and EZ-fill cartridges that are very accretive for us. So that's why we refer also in Q3 to better mix.

So we are confident and reiterating our guidance that is implying almost 50% high-value solution in Q4. And the main drivers are, again, syringes, Nexa syringes and EZ-fill vials and cartridges for that.

Franco Stevanato

Today, I capture your second question, we believe we will be on the range of low single digits in 2027 because we have already backfilled most of these syringes. These are high-value product syringes, Nexa, but we are not complete to have completed this backfill because it is taking time.

So we have a strong pipeline of new customers coming, but we need also still some quarters to finalize additional validation for new programs. Just to give an order of magnitude, if we for this temporary headwind, we believe we will have grown in line with our long-range plan of high single digit to low double digit in 2027. And again, the BDS Segment is already delivering this performance is now close to 2 years.

Operator

Next question is from Curtis Moiles, BNP Paribas.

Curtis Moiles

First, I just wanted to start on these other containment solutions. Maybe can you give a little bit of additional color on what drove that strong 23% growth there? It sounds like it wasn't related to the GLP-1 competition. So any additional color would be good.

And then secondly, just on the BBS gross margin. Can you maybe quantify the impact of the high utility costs that were called out? And maybe is that expected to continue into Q4? And is sort of year-over-year expansion in Q4 still a good assumption?

Franco Stevanato

So thanks for the question, Curtis. We start from other containment delivery solutions. Q3 was strong, driven -- we can see strong demand in bulk cartridges. We started to gain traction with our CMO contract for drug delivery system in Fishers.

So all overall, in the quarter, other containment are growing. We also included in other containment the variable compensation because we decided to put there because we did not deliver the product and we didn't want to inflate our main KPIs like high-value solutions and GLP-1 revenue. So contributed also this. But I was saying before, for high-value solution, we can see quarterly fluctuation. And in Q4, we will talk about different mix and different figures.

The question about utility is very clear. As you know very well, in Europe, the gas price went up significantly in Q3. And with that also the energy price went up. We have long-term relationship with our customers with adjusting price mechanism in place and fair discussions ongoing, but it's taking a little bit of time to adjust the prices when the increase is so sudden, I would say.

About Q4, it's a very good question. It depends obviously also the geopolitical situation. We are cautiously assuming that it will stay slightly above Q3 prices, and it is embedded in our guidance. We had, let's say, similar experience in 2022 when the gas price went up significantly, and we are very confident we can manage the situation.

Operator

Next question is from Albert Hu, Citi.

Albert Hu

So you called this GLP headwind a temporary moderation in 2027. So without this headwind, you also mentioned the year could be back to LRP. So does that mean the current expectation is for 2028 to be the LRP year that you're hitting as the GLP-1 moderations lapse? And if you can remind us what that LRP algo means for margins and EPS. Just want to make sure we get the timing here right.

Franco Stevanato

Besides the fact that we will -- for what is related to the 2027 number, we will share on March, and what is beyond 2027, based on the pipeline that we have both in biologics, in GLP-1, in other products, we would expect to return to more normalized growth beyond 2027 in terms of revenue and to be also in the trajectory of our strategy in order to reinforce our margin and generation of cash and to expand our high-value product.

Remember, during the Capital Market Day, our goal was to be in high single digit, low double digit in terms of revenue to run on a range of 29%, 30% of EBITDA and to generate good cash flow in order to return on our investment.

Today, we are still in this trajectory, looking at the nature of the program that we have with our customers that are mostly into the high-value product range between Alba, cartridges-to-fill, Nexa syringes, and drug delivery system, and vial-to-fill. So we are confirming our strategy.

Marco Dal Lago

s

And as Franco mentioned, we have several tools to further improve our profitability after doing it in '25 and '26. Particularly we just reached breakeven in Fishers. Our plan is to keep on expanding profitability in Latina and Fishers, leveraging the capacity to install in high-value products. So we can play different tools in order to further expand our profitability. That is our goal for the years to come.

Franco Stevanato

In fact, last point, besides this moderate growth that we face temporary in 2027 based on the strategy and also the fact that we are bringing full potential, our big investment, we continue to be in the right direction also in 2027 to reinforce our -- expand our margin and to generate also better free cash flow in 2027.

Albert Hu

Got it. Perfect. And then maybe moving to -- on margin side. It's nice to see Fishers hitting gross margins breakeven here. Can you remind us what this now means for BDS margins?

If you can walk us through how Fishers, Latina, given the progress in 3Q, how they play part in the margin Alba this year? And then I guess, what does that set up BDS margins to be next year, maybe just on the broader level?

Marco Dal Lago

s

While it's too early to provide to you a full model for 2027, what I -- what we can tell you is that we have a clear plan for Fishers to fully ramp up at the end of 2028. We are installing there capacity with large majority for high-value solutions, where the gross profit margin is from 40% to 70%, depending on the type of products.

So all overall, we expect Fishers to be accretive for the segment when fully ramped up. To get there, it will be a step-by-step quarter after quarter improvement in operational KPIs and in financial consequently.

Today, as a reminder, we stall approximately 50% of the capacity in Fishers, and we are not using at full speed. So we are -- we can see month after month improvement in utilization and in further installation value products, and we believe we will be able to reach the full capacity at the end of 2028.

Franco Stevanato

Same is for Latina that we are starting to produce Nexa syringes since now 2 years. We are satisfied about the marginality that we are able to deliver this high-value product in Latina. On the top of this, we are starting now to do the validation and the SAP of our RTU 400 cartridges that is a high-value product that will start to generate revenue in 2027. So this is another element that will help to continue to grow in 2027.

Operator

Next question is from Justin Bowers, Deutsche Bank.

Justin Bowers

Just wanted to clarify a couple of comments that you've made thus far. So one, if GLPs were not be selling related to this one program, you would be growing within the LRP. So it sounds like this is the primary headwind. Is there any other headwinds?

Or is this it, number one? Number two, I also want to clarify that this is isolated to the syringes and not any part of the portfolio.

Franco Stevanato

So today, this temporary headwind that we are facing in 2027 is related to Nexa syringes. We don't have up to now other headwind in 2026 and 2027. And I want to say maybe it's the reverse, the demand that we have in our high-value product is quite robust.

Like I mentioned to you, we have a strong demand on cartridges-to-fill. This is why we are blocked, we are continuing to invest in capacity. The same is for the Alba technology. Also if you look also the capacity that we are building up for our drug device program, both Alina and while we work in the CMO business model, also here, the capacity that we have put in place is driven by the demand from the customers.

So to your question, it's related to one customer to the syringes is the only headwind that we are facing at this moment.

Justin Bowers

I appreciate that. And then a follow-up to that would be, it sounds like you've backfilled most of the demand. And I just want to confirm that that's just the timing of sort of the reason why it's not additive or fully replacing the growth next year is just phasing and timing and customer acceptance and validation. So that's part one.

And then part two would be, if you didn't have this headwind in GLP-1, would you have enough capacity to meet the demand for the temporary headwind in GLPs and this additional demand that you're backfilling in other parts of biologics? Or would that require you to add additional capacity?

Franco Stevanato

Yes. So today, we have started to backfill most of this capacity with our syringes. And we have done a good job because we have backfilled with many customers in Nexa syringes.

It's also true that this requires some timing to fully recover all the capacity. I think we need also 2027 to backfill this. We see that it is only a temporary moment because looking ahead, the pipeline that we have in all our product portfolio in high-value products, we have robust demand that will enhance really to continue to grow in the next year on this range of high single digit to low double digit.

Like I mentioned to you today, if it were not for this temporary headwind, there was no particular issue to continue to grow high single digit, and BDS Segment most probably on double digit is also true that if we are not with this customer also Nexa syringe, we were in a situation to be close to full capacity in this moment.

But the sentiment I want to pass to you, this is a temporary in 2027 that we have mostly backfill, but because of the nature of the entity of this temporary headwind, it's going to take a little bit more quarters. Our goal is to normalize in 2028.

Marco Dal Lago

And we have a plan to add capacity in Fishers as part of our plan. So to your question, our plan is matching the future capacity we have in our medium-term plan.

Operator

Next question is from Anna Snopkowski, KeyBanc.

Anna Snopkowski

Just one follow-up for me on the engineering side. I think you kind of touched on this with Mac's question earlier, but are the delayed orders you're seeing in engineering tied to the same GLP-1 customer you mentioned? And would you consider any alternatives for engineering?

Franco Stevanato

Yes. The delay that we are facing and that will generate temporary headwinds in 2027, both in the BDS Segment and Engineering are tied to the same customer, correct. In the meantime, we have, like I mentioned to you before, a strong pipeline of new orders from existing international customer, new customer, both in inspection, assembly. The only point that we are struggling, that is the conversion of this pipeline into confirmed orders.

Operator

Next question is from Matt Larew, William Blair.

Franco Stevanato

What I can add you more is today, what we are going to monitor more and more is in Stevanato Group is that in the Engineering Segment, we are not where we were looking to be. We have performed some good operational progress, but we are still -- we are not in the situation where we are looking.

In fact, in Stevanato Group today, like I mentioned to you already last time, we continue to assess internally what is the best interest from strategic point of view in order to serve better our customers, even more also to grow our portfolio in high-value solution and expanding margin.

So coming back to the engineering that we have to split the discussion into 2 parts. First, for what is related to our internal competitive advantages that we launched more than 30, 40 years, that is the internal technology that we develop for the group in terms of glass converting, EZ-fill technology, needle assembly.

And this is enhanced Stevanato to take this strong position into the biologics space, look at the development that we have done for Alba, the development that we have done for our EZ-fill cartridges, product-to-fill, the other programs that we are going to develop and patent.

The second aspect of the Engineering division is the vision inspection and assembly business. That is a good business, but they remain dilutive to our corporate margin. So while this really bring this inspection and assembly good -- is dilutive, is bringing also good value for the customer, we continue to assess inside of Stevanato Group what is the best for Stevanato.

Today, at the end of the game, we want to really laser-focused to meet the need of our customers, in particular for everything that is related to injectable space and even more to reposition our product to high-value product. And we continue to assess this.

And if you look also what we have done months ago, we have announced that we have divested the California plant. Today, our goal is more and more to localize all our organization in order to be the best partner for our biologics space and even more to really reposition our product.

Lisa Miles

Operator, any last questions?

Operator

We have no more questions registered at this time. The floor is back to you for any closing remarks.

Lisa Miles

I just want to thank everyone for joining the Stevanato Group third quarter 2026 earnings call, and we look forward to future engagements. Have a good day.

Operator

Ladies and gentlemen, thank you for joining. The conference is now over. You may disconnect your telephones.