SINTXテクノロジーズ（SINT）2026年第3四半期決算説明会：売上高953%急増

主なポイント

• 2026年第3四半期の売上高は、主に航空宇宙向け精密製造製品の売上増加により、前年同期比953%増の220万ドルとなった。
• 粗利益は9万3,000ドルから約140万ドルに増加し、価格改定、良好な製品ミックス、生産量増加、固定費吸収の改善により、粗利益率は45%から62%へと拡大した。
• 純損失は55%縮小して160万ドルとなった。営業費用は13%減少し、300万ドルとなった。
• SINTXは2026年中に米食品医薬品局（FDA）の510(k)認可を取得した足部・足関節用ウェッジシステム「SiNAPTIC」からの商業売上の計上を開始し、限定販売から本格的な商業化へと移行した。
• 2026年9月30日時点の現金および現金同等物は計200万ドルとなった。当四半期末後には、資金払い込みを伴うクラスBワラントの行使および関連する交換により、約200万ドルの総収入が生じた。
• 経営陣は、生産および出荷時期の不確実性を理由に、6月に受領した320万ドルの受注残分について、第4四半期における納品見通しの更新された予想を示すことができなかった。

主要財務業績

2026年第1〜第3四半期（9カ月間）の累計売上高は前年同期比315%増の300万ドルとなり、製品売上高は424%増の280万ドルに達した。粗利益は553%増の180万ドルとなり、純損失は前年同期の810万ドルから710万ドルへと縮小した。

当四半期末時点におけるSINTXの現金および現金同等物は、2025年12月31日時点の410万ドルに対し、200万ドルとなった。流動資産は550万ドル、流動負債は300万ドル、株主資本は340万ドルであった。製造活動および予想される需要に対応するため原材料、仕掛品、製品を積み増したことから、棚卸資産は100万ドルから260万ドルに増加した。

事業および営業動向

産業および航空宇宙向けセラミックス製造が引き続き主な売上貢献要因となった。経営陣によると、SINTXは過去のどの四半期よりも多くの窒化ケイ素部品を製造・納品した。また、第3四半期の売上高は、同社が以前提示していた90万ドル〜110万ドルのガイダンス範囲の上限の2倍に達した。

同社は、この力強い業績達成の要因として、顧客関係の強化、製造工程の改善、そしてフォーチュン500に選ばれる航空宇宙企業からの受注に対する納品加速を挙げた。経営陣は、生産能力の増強、リピート注文の獲得、特殊セラミックス製造を必要とする提携を通じて、より強固な産業向け売上基盤の構築を目指している。

医療機器分野では、窒化ケイ素製足部・足関節用ウェッジシステム「SiNAPTIC」の本格的な商業展開が開始された。販売代理店は米国の主要な足部・足関節外科医をターゲットとしており、SINTXは既存の外科医や医療機関との関係を生かした提携を検討している。経営陣は、普及状況、製品の供給体制、リピート手術件数、売上高が商業化の進捗を測る主な指標になると述べている。

また、SINTXは窒化ケイ素とPEEKの生体複合材料プラットフォーム「SiNERGY」の開発を進めている。エボニック（Evonik）は、SINTXが供給する材料を用い、同社の特許に基づいて商業規模のPEEKおよび窒化ケイ素フィラメントを製造している。SINTXは3Dプリンティング製造施設を立ち上げ、カスタムメイドおよび患者特異的な整形外科用インプラントに向けたワークフローの開発を開始した。

大動物を用いた生体内（in vivo）試験では、窒化ケイ素処理を施した縫合糸および創傷被覆材の抗菌性ならびに癒着防止・瘢痕抑制特性を評価している。経営陣は、これらの試験が次の四半期中に完了すると見込んでいる。商業化やライセンス供与の実現は、今後の追加試験や関連する規制当局の認可・承認の取得が前提となる。

業績見通し（ガイダンス）

経営陣は精密製造の需要が過去の水準を上回る状況が続くと見込んでいるものの、四半期売上高は顧客の発注規模、生産スケジュール、出荷時期によって変動する可能性があると注意を促した。

同社が以前公表した2026年第4四半期の売上高ガイダンスは、6月に受領した320万ドルの受注に対する納品見込みに基づいていた。SINTXは、残りの注文のうちどれだけが第4四半期中に納品され売上計上されるかについて、現時点では見通しを示すことができないと説明した。

経営陣は短期的には営業損失が継続すると予想している。優先事項として、持続的な粗利益の創出、営業キャッシュフローの改善、規律ある費用および運転資本の管理、SiNAPTICの商業化、3Dプリント窒化ケイ素複合材料の進展、医療用テキスタイルのライセンス供与機会の追求を挙げている。

リスク要因および注視点

• SINTXは引き続き営業損失を計上し、キャッシュを消費している。2026年第1〜第3四半期（9カ月間）の営業活動に使用された純キャッシュは660万ドルであった。
• 同社は追加のエクイティおよびデットによる資金調達を検討している。当四半期末時点で、市場実勢価格売出（ATMプログラム）に基づく発行可能枠は約500万ドル残っていたが、これは市場環境や募集上限に左右される。
• 売上高が大口の産業向け受注に偏重しているため、生産および出荷のタイミングによって四半期業績が大きく変動する可能性がある。
• SINTXが製造および商業化の能力増強に投資したことで棚卸資産は260万ドルに増加しており、需要を出荷および現金へ確実に転換することの重要性が高まっている。
• 医療用テキスタイルやその他のパイプライン製品の商業化には、事前の追加試験および関連する規制当局の認可・承認の取得が必要となる。

決算説明会の全編文字起こし

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, today's call is being recorded. I would now like to turn the call over to SINTX Technologies Chief Legal Officer, Kevin Ontiveros.

Kevin Ontiveros

Thank you, operator, and good afternoon, everyone. Earlier today, SINTX Technologies released its financial results for the quarter ended September 30, 2026, and filed its quarterly report on Form 10-Q with the Securities and Exchange Commission. These materials, together with a replay of this call, will be available through the Investor Relations section of the SINTX Technologies website.

Before we begin, I want to remind listeners that statements on today's call, other than historical facts, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These include statements about customer orders, production, and shipment schedules, future revenue and guidance, gross margins, medical device commercialization, surgeon and distributor adoption, research and development, intellectual property, strategic relationships, potential financing and warrant exercises, liquidity and business outlook. They reflect current expectations, involve risks and uncertainties, and actual results may differ materially. Please review the risk factors and other disclosures in our latest Form 10-K and 10-Q and subsequent SEC filings.

SINTX undertakes no duty to update these statements except as required by law. Unless otherwise noted, financial measures discussed today are presented on a U.S. GAAP basis. Joining me are Eric Olson, our Chairman and Chief Executive Officer, and Kevin Trask, our Chief Financial Officer. Eric will provide the business and strategic update. Kevin will review financial results and liquidity. And Eric will close with our near-term priorities. At this time, I would like to turn the call over to Eric Olson. Eric?

Eric Olson

Thank you, Kevin. And thank you to everyone for joining today's call. Our third quarter performance marks an important step in SINTX's transition into a commercially driven advanced biomaterials company. For many years, the strength of SINTX has been its silicon nitride technology, manufacturing expertise, and research and development capabilities. Today we can announce that we have translated these strengths into sustainable commercial revenue and gross profits.

I would like to highlight several third quarter takeaways. First, SINTX has manufactured and delivered more silicon nitride parts than in any other quarter in the company's history. Third quarter revenue grew 953%, reaching approximately $2.2 million compared with $208,000 a year earlier. This represents a meaningful step up in demonstrating commercial scale, driven primarily by our industrial and aerospace ceramics manufacturing operations. Second, gross profits reached approximately $1.4 million, while our net loss narrowed by 55% year-over-year. Third, achieving the Q3 revenue milestone allowed us to execute a warrant call which resulted in gross capital proceeds of approximately $2 million, as well as the expiration of unexercised warrants that would have covered the issuance of an additional 941,000 shares, reducing the dilution to existing shareholders. We anticipate the revenue from the industrial sales vertical will support us as we continue our transition to addressing unmet needs in medical devices and medical textiles, while also working to bring our cost structure more in line with our revenue.

The update we will discuss today reinforces both our short- and long-term business strategies focused on: first, industrial and aerospace revenue growth; second, commercialization of our FDA 510(k)-cleared SiNAPTIC silicon nitride system for foot and ankle procedures; third, moving our silicon nitride PEEK 3D-printed orthopedic implants closer to commercialization; and fourth, the licensing of silicon nitride-treated medical textiles for wound closure and wound care applications. These strategies are possible thanks to our one-of-a-kind vertically integrated manufacturing facility, the only facility registered with the FDA to manufacture medical-grade silicon nitride biomaterials. This manufacturing capability, combined with our recent patents for integrating silicon nitride into composites and textiles, has allowed our platform to begin moving forward beyond traditional orthopedic devices into other exciting biotech applications.

As the only global manufacturer of medical-grade silicon nitride, we believe our priorities reflect a business that is not just about a single quarter's growth. It is about our ability to leverage a biomaterial platform to convert customer demand into delivered products and overall revenue growth. With that context in mind, I'd like to begin discussing our revenue growth in Q3 and what that means for the future of our silicon nitride business. Industrial manufacturing remained the primary contributor to third quarter revenue. Our experience in material formulation, precision manufacturing, and repeatable processing gives us an opportunity to deepen relationships with established industrial customers who need reliable components that perform in demanding environments. Purchase orders received this year from Fortune 500 aerospace companies informed the guidance we offered in our second quarter earnings call, where we indicated an expected revenue range of $900,000 to $1.1 million for the third quarter. Our ability to double the high end of these expectations is not only a testament of customer satisfaction, it is also a reflection of improvements in our manufacturing and operational efficiencies.

Importantly, this execution demonstrated our capacity to manufacture at scale, which will become even more critical when applied to our medical device manufacturing throughput. As we discussed in our previous calls, receipt of these purchase orders represented the beginning of the work, not the completion of it. We indicated then that the important milestones included repeatable production, manufacturing yield, on-time delivery, and recognized revenue. We are pleased to report that we have demonstrated objective success in achieving these milestones and on an accelerated basis. Our ambition is to turn the success into a durable commercial foundation—that is, increasing capacity, obtaining repeat orders, and generating revenue that can support further development of our proprietary biomaterial platform. We are also expanding our dialogue with prospective manufacturing partners where our ceramic expertise can help solve specific technical challenges. The revenue from industrial sales provides an important source of growth and operational leverage as we expand our medical device biomaterial platforms.

To provide some quick background for listeners new to the SINTX story, the unique molecular properties of silicon nitride make it the ideal biomaterial for medical devices. Silicon nitride has several material characteristics that we believe make it attractive for medical device applications. These properties include being naturally antipathogenic and antimicrobial, which may decrease the likelihood of revision surgery during or due to infection; and osteoconduction, or the ability to stimulate bone growth, which could accelerate natural healing and help to prevent implant failures in the future. Implant-associated infections cost the U.S. healthcare system approximately $3 billion to $5 billion every year. Once bacteria adhere to implants made of other materials such as metal or plastic, the bacteria becomes more resistant to antibiotics. Silicon nitride, on the other hand, has been shown to not only inhibit the bacterial attachment in the first place, but to actually kill the bacteria as well. Published studies regarding silicon nitride have shown that these features may help to accelerate patient healing while also being less likely to cause allergic reactions and also provide more clear radiographic visibility than any other material, allowing for precise placement of implants in critical anatomic locations.

Our lead proprietary silicon nitride product in this vertical remains the FDA 510(k)-cleared SiNAPTIC foot and ankle wedge system. This implant system entered clinical use in the United States earlier this year, and we have begun the process of building a commercial channel around it. As you may recall, the SiNAPTIC system consists of silicon nitride wedges, which are being used in reconstructive procedures, including those to correct mid- and hindfoot pathologies, and potentially for sports medicine applications as well. Following the completion of our limited market release that we have discussed in our previous call, full commercialization has now begun with distributors targeting the lead foot and ankle surgeons in the United States, while we also explore other strategic opportunities with partners that have existing relationships with facilities and foot and ankle surgeons. Commercial success of the system will be measured through surgeon adoption, product availability, repeat procedures or stickiness, and meaningful revenue. We are also evaluating capital-efficient routes to market, and we intend to build effective distribution and clinical support models, maintaining manufacturing and quality discipline.

Beyond monolithic silicon nitride implants, our technology initiatives are intended to extend silicon nitride into new material formats and applications, including polymer composites and 3D manufacturing. We are pursuing commercialization strategies for patient-specific and custom implants, and we are entering into collaboration with partners who have the design, regulatory, and distribution capabilities needed to bring advanced products to market. We also continue to assess applications involving medical textiles, wound care, wound management, and other potential antipathogenic applications. 3D printing of orthopedic implants allows us to distribute a vast array of AI-assisted custom and patient-specific implants with complex geometries and patient-specific designs that may be difficult to achieve using traditional manufacturing methods.

We believe these capabilities create new opportunities for our silicon nitride PEEK biocomposite platform. Last year, we announced the manufacturing agreement with Evonik, a leading global manufacturer of PEEK and PEEK-based filaments for 3D printing applications. Operating under our patent and using silicon nitride material provided by SINTX, Evonik produces a commercial-scale composite filament of PEEK and silicon nitride for these 3D-printed devices. Our patented silicon nitride PEEK biocomposite, which will be marketed as part of our SiNERGY biocomposite platform, combines the characteristics of these two materials and may offer advantages for certain orthopedic applications. We anticipate that 3D printing using the filament provided by Evonik may result in greater manufacturing yields, lower cost of goods, and less waste material than other manufacturing processes. Already, SINTX manufacturing and innovation teams have created a new 3D printing manufacturing facility and have also begun developing the custom workflows for these 3D-printed implant applications.

SINTX is also currently conducting large-animal in vivo studies to evaluate the effectiveness of medical textiles treated with silicon nitride and to advance preclinical work evaluating the antimicrobial and anti-adhesion scar reduction properties of silicon nitride-treated sutures and wound dressings for various wound healing and wound management applications. We anticipate that these studies will be completed in the next calendar quarter. These large-animal studies are intended to help generate data regarding the healing performance of these materials in relevant wound environments and to inform future development and potential commercial partnering activities. We believe this represents a promising opportunity to extend our silicon nitride technology platform beyond traditional orthopedic implants. Ongoing testing and applicable regulatory clearances or approvals will be required before the commercialization or licensing of any resulting medical devices. The long-term vision is to create a licensing platform that would allow partners to integrate patented silicon nitride technologies into their own medical textiles. We expect the outcome of these studies to inform the commercial strategy for these particular wound care and wound management applications and look forward to providing updates on this study's progress.

To conclude, the milestones we have discussed today reflect a record quarter of meaningful execution across all of our core strategic priorities. While each of these initiatives are important on their own, together they demonstrate the progress we are making towards commercialization and the long-term strategy we have previously outlined. With that, I will turn the call over to our Chief Financial Officer, Kevin Trask, for more details on the quarter's financial results.

Kevin Trask

Thank you, Eric, and good afternoon, everyone. Total revenue for the three months ended September 30, 2026 was $2.2 million, an increase of 953% compared with $208,000 in the prior year period. Product revenue was $2.1 million compared with $150,000 in the third quarter last year. The increase in revenue was primarily driven by higher sales of our aerospace technical manufacturing products. These results reflect the progress we have made in strengthening customer relationships, improving our manufacturing capabilities, and executing on customer orders. While the timing and size of customer orders may result in fluctuations in quarterly revenue, we expect continued demand for our products at levels above those experienced in prior periods. Grant and contract revenue was $100,000 compared with $58,000 in the prior year period.

Gross profit for the quarter increased to approximately $1.4 million compared with $93,000 in the prior year period. Gross margins were 62% compared with 45% in Q3 2025. The improvement in gross margin was primarily driven by pricing adjustments implemented earlier this year, favorable product mix, and increased production volumes, which contributed to improved manufacturing efficiencies and better absorption of fixed manufacturing costs.

Total operating expenses for the quarter were $3 million compared with $3.4 million in the prior year period, a decrease of 13%. Net loss decreased 55% to $1.6 million compared with $3.5 million in the prior year period. Research and development expenses were $548,000 compared with $1.3 million in the same period in 2025. The decrease in reported R&D expenses primarily reflects the reallocation of certain overhead costs from research and development to general and administrative expenses as our operations have evolved towards increased commercial manufacturing activity. While these changes have reduced reported R&D expenses, they do not represent a corresponding reduction in our underlying research and development efforts. General and administrative expenses for the third quarter were $2.5 million to $3 million compared with $2.1 million in the prior year period, a 7% increase. Sales and marketing expenses for the quarter were $140,000 compared with $59,000 in the prior year quarter. The increase reflects greater commercialization activities with the launch of new products.

Turning to year-to-date results, total revenue for the nine months ended September 30, 2026 was $3 million, an increase of 315% compared with $728,000 in the same period last year. Product revenue for the first nine months of 2026 was $2.8 million compared with $541,000 in the prior year period, an increase of 424%. The increase in year-to-date revenue was primarily driven by higher OEM technical manufacturing sales, particularly in the third quarter of the year. During the quarter, we also began recognizing commercial revenue from our SiNAPTIC foot and ankle wedge system during 2026, marking an important milestone in our medical device commercialization efforts.

Gross profit for the first nine months of 2026 was $1.8 million compared with $273,000 in the prior year period, an increase of 553%. Net loss for the first nine months of 2026 decreased to $7.1 million compared with $8.1 million in the prior year period. The reduction in our year-to-date net loss reflects improved gross profitability and our continued focus on operating efficiencies and disciplined expense management.

Turning to our balance sheet, cash and cash equivalents were $2 million at September 30, 2026, compared with $4.1 million at December 31, 2025. The decrease in cash primarily reflects cash used in operating activities and investments in working capital to support increased manufacturing and commercialization activities, partially offset by proceeds from financing activities. At September 30, 2026, we had current assets of $5.5 million, current liabilities of $3 million, and total stockholders' equity of $3.4 million. Inventory at quarter-end was $2.6 million compared with $1 million at year-end 2025. The increase in inventory primarily reflects additional raw materials, work-in-process, and finished goods to support increased manufacturing activity and anticipated customer demand. These investments are intended to support our expanding commercialization operations, including our industrial manufacturing activities and medical device commercialization efforts.

Net cash used in operating activities was $6.6 million for the first nine months of 2026, compared with $6.2 million in the prior year period. Net cash provided by financing activities for the first nine months of 2026 was $4.7 million, compared with $7.9 million in the same period last year. At quarter-end, we had approximately $5 million of remaining capacity under our at-the-market offering, subject to market conditions and applicable offering limitations.

Subsequent to quarter-end, we exercised our right to call the Class B warrants issued in connection with our June 2026 financing after achieving the required quarterly revenue milestone. As announced on October 9, 2026, we received approximately $2 million in aggregate gross proceeds from funded warrant exercises and related exchanges covering approximately 941,000 Class B warrant shares. The remaining unexercised Class B warrants covering approximately 941,000 additional shares expired without consideration, eliminating the potential dilution associated with those unexercised Class B warrants.

Although our improved third quarter financial performance and the proceeds from the Class B warrant exercises have strengthened our liquidity position, we continue to incur operating losses and use cash in our operations. We remain focused on improving operating cash flow, managing working capital and expenses, and evaluating additional sources of capital to support our business objectives. We continue to evaluate opportunities to raise additional capital through equity and debt financing to support our ongoing operations and commercialization initiatives.

Although we anticipate continued operating losses in the near term, we are encouraged by the progress made in increasing revenue, improving gross margins, and managing operating expenses. We believe these improvements provide a stronger operational foundation as we continue to execute our growth strategy. We are particularly pleased with our third quarter revenue performance, which exceeded by 2x the high end of the revenue guidance range provided during our previous earnings call. And we continue to expect technical manufacturing demand to remain above historical levels.

Quarterly revenue may fluctuate based on the timing and size of customer orders, production schedules, and shipment timing, but we remain focused on sustainable gross profit generation and converting demand into cash rather than treating a single strong quarter as a guaranteed future run rate. Looking ahead, our previously communicated revenue guidance for the fourth quarter of 2026 was based on expected timing of delivery against the $3.2 million in purchase orders received in June. As mentioned earlier, the timing and delivery of those orders may result in revenue fluctuations, and at this time we are unable to offer an expectation related to order delivery for the remainder of those purchase orders relative to the fourth quarter of 2026. We look forward to greater visibility on the matter as information becomes available. With that, I will turn the call back to Eric for closing remarks.

Eric Olson

Thank you, Kevin. This quarter, SINTX has clearly demonstrated our ability to translate commercial activity into financial progress. While there is still important work ahead, our third quarter results show what our team can accomplish when customer demand, technical manufacturing, and commercial execution come together.

In closing, I'd like to reemphasize our four priorities as we move through the remainder of 2026 and into 2027: first, reliable manufacturing and commercial execution of our industrial and aerospace products; second, commercialization of the SINTX foot and ankle implant system; third, advancement of silicon nitride composites for 3D manufacturing; fourth, identifying licensing opportunities of our silicon nitride textiles alongside strategic partners; and finally, disciplined management of our costs and working capital.

We believe the company is well positioned to execute on the opportunities in front of us and to continue advancing toward commercialization across multiple verticals. As we prepare for further growth in 2027, our commitment is to report measurable milestones and to keep converting the technology we have built into products that customers value. We look forward to updating you on our continued progress in the quarters ahead. Thank you to our employees, customers, clinical collaborators, and shareholders for the success of this quarter.

Operator

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

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