Codexis, Inc. (CDXS) 2026 Q1 法說會逐字稿

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  • Operator

    Operator

  • Greetings, and welcome to the Codexis Report 2026 Q1 earnings call. (Operator Instructions) As a reminder, this conference is being recorded. It is now my pleasure to introduce Georgia Erbez, Chief Financial Officer and Chief Business Officer. Please go ahead.

    各位好,歡迎參加 Codexis 2026 年第一季財報電話會議。(接線員指示)提醒各位,本次會議將被錄音。現在我很榮幸介紹 Georgia Erbez,首席財務長兼首席商務長。請開始。

  • Georgia Erbez - Chief Financial Officer, Chief Business Officer

    Georgia Erbez - Chief Financial Officer, Chief Business Officer

  • Thank you, operator. With me today are Dr. Alison Moore, Codexis' President and Chief Executive Officer; and Britton Jimenez, Senior Vice President, Sales and Marketing.

    謝謝,接線員。今天與我一同出席的有 Codexis 總裁兼執行長 Alison Moore 博士,以及銷售與行銷資深副總裁 Britton Jimenez。

  • During this call, management will be making a number of forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including our guidance for 2026 revenue, anticipated milestones, including product launches, facility expansions, technical milestones and public announcements related thereto as well as our strategies and prospects for revenue growth and successful execution of current and future programs and partnerships.

    在本次電話會議中,管理團隊將依據 1995 年《私人證券訴訟改革法》之定義,發表若干前瞻性陳述,包括我們對 2026 年營收的指引、預期里程碑(包含產品上市、設施擴建、技術里程碑及相關公開公告),以及我們對營收成長與成功執行現有及未來計畫與合作夥伴關係的策略與展望。

  • To the extent that the statements contained in this call are not descriptions of historical facts regarding Codexis, they are forward-looking statements reflecting the beliefs and expectations of management as of the statement date, May 7, 2026. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond Codexis' control and that could materially affect actual results.

    就本次電話會議所載之陳述而言,凡非對 Codexis 歷史事實之描述者,均屬前瞻性陳述,反映管理團隊截至陳述日期(2026 年 5 月 7 日)的信念與預期。您不應過度依賴這些前瞻性陳述,因其涉及已知與未知之風險、不確定性及其他因素,其中部分超出 Codexis 的控制範圍,且可能對實際結果造成重大影響。

  • Additional information about factors that could materially affect actual results can be found in Codexis' filings with the Securities and Exchange Commission. Codexis expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

    有關可能對實際結果造成重大影響之因素的更多資訊,請參閱 Codexis 向美國證券交易委員會(SEC)提交的文件。除法律另有規定外,Codexis 明確聲明不負有更新這些前瞻性陳述之任何意圖或義務。

  • Now I'll turn the call over to Alison.

    現在我把電話交給 Alison。

  • Alison Moore - Executive Vice President, Chief Technical Officer

    Alison Moore - Executive Vice President, Chief Technical Officer

  • Thank you, Georgia, and thanks, everyone, for joining. While it's been a short eight weeks since our last call, we've accomplished a lot at Codexis. We are pleased to report another strong quarter and are busy preparing for the TIDES Conference next week, where we will present important new data on our ECO Synthesis technology.

    謝謝你,Georgia,也謝謝各位參與。雖然距離上次電話會議只有短短八週,我們在 Codexis 已完成了許多工作。我們很高興再度報告一個強勁的季度表現,同時也正忙於準備下週的 TIDES 會議,屆時我們將發表關於 ECO Synthesis 技術的重要新數據。

  • Codexis generates manufacturing solutions using biocatalytic enzymes. Over the last three years, we have developed the ECO Synthesis manufacturing platform for the production of RNA medicine, specifically siRNA, and we are now focused on bringing this to the market. The standard approach of using solid phase organic synthesis for siRNA manufacturing is complex, solvent-intensive and challenging to scale.

    Codexis 透過生物催化酵素提供製造解決方案。過去三年,我們已開發 ECO Synthesis 製造平台,用於生產 RNA 藥物,特別是 siRNA,目前我們正專注於將其推向市場。以固相有機合成進行 siRNA 製造的標準方法相當複雜、溶劑用量大,且難以放大規模。

  • Currently, siRNA pipelines are expanding from rare diseases to large population indications, which will create a significant manufacturing bottleneck in the next three years. ECO Synthesis has the potential to alleviate production constraints by delivering greater scalability and higher product quality with the added benefit of dramatically improving environmental impact.

    目前,siRNA 研發管線正從罕見疾病擴展至大族群適應症,這將在未來三年造成顯著的製造瓶頸。ECO Synthesis 有潛力透過更高的可擴展性與更高的產品品質來緩解產能限制,並且還能大幅改善環境影響。

  • Last year, we achieved a number of important milestones in platform performance and industry engagement, which generated tangible interest from our customers. In 2026, the potential impact of our platform is well understood. Across the industry, we are seeing increased interest in enzymatic production solutions. Our goal is to position Codexis as the leading manufacturing technology innovator. We are operationalizing our platform through scaling, improving process control and by our platform's unique capability of delivering superior siRNA product.

    去年,我們在平台效能與產業互動方面達成多項重要里程碑,並引發客戶具體的興趣。在 2026 年,我們平台的潛在影響已被充分理解。在整個產業中,我們看到對酵素生產解決方案的興趣正在增加。我們的目標是將 Codexis 定位為領先的製造技術創新者。我們正透過擴大規模、改善製程控制,以及平台獨特的能力(可提供更優異的 siRNA 產品)來推動平台營運化。

  • A new feature of our ECO Synthesis platform is the ability to generate siRNA with specific stereochemical control. Stereoisomers exist at both ends of most siRNA molecules and are made of the same atoms but are arranged differently in three-dimensional space. As a reminder, drug developers have little influence over stereochemistry today as existing chemical manufacturing methods produce random mixtures that can vary in terms of therapeutic potency and purity.

    我們 ECO Synthesis 平台的一項新特點,是能夠生成具有特定立體化學控制的 siRNA。多數 siRNA 分子的兩端都存在立體異構體;它們由相同的原子組成,但在三維空間中的排列方式不同。提醒各位,目前藥物開發者對立體化學的影響力有限,因為既有的化學製造方法會產生隨機混合物,而其治療效力與純度可能有所差異。

  • Our engineered enzymes used in ECO Synthesis can deliver product with specific stereoisomer configurations. These stereopure molecules confer overall improved product quality and have the potential to deliver improved potency. We continue to explore the biological impact of this control and believe it could be a tremendous asset to those customers who seek ways to improve their products.

    我們在 ECO Synthesis 中使用的工程化酵素,能夠提供具有特定立體異構體構型的產品。這些立體純(stereopure)分子可帶來整體更佳的產品品質,並有潛力提升效力。我們持續探索此控制對生物學層面的影響,並相信對於尋求改善其產品的客戶而言,這可能是一項極具價值的資產。

  • Our small molecule biocatalysis business remains an important part of Codexis and provides support for the investments we are making in ECO Synthesis. We supply uniquely designed enzymes for 13 branded commercial pharmaceutical products. This portfolio continues to grow with the recent approval of islatravir, a part of an important new combination treatment for HIV.

    我們的小分子生物催化業務仍是 Codexis 的重要組成,並為我們在 ECO Synthesis 上的投資提供支撐。我們為 13 款具品牌的商業化處方藥產品供應獨特設計的酵素。隨著 islatravir 近期獲准上市(其為一項重要 HIV 新型複方治療的一部分),此產品組合持續成長。

  • Codexis partnered with Merck, who carried out groundbreaking process chemistry, substituting a 16-step chemical synthesis with a biocatalytic cascade. This achieved a Green Chemistry Award in 2025. We are supplying enzymes for this commercial product and are proud to participate in the supply chain for HIV patients.

    Codexis 與默克(Merck)合作,由其完成突破性的製程化學工作,以生物催化級聯反應取代 16 步的化學合成。此成果於 2025 年獲得綠色化學獎(Green Chemistry Award)。我們為該商業化產品供應酵素,並很自豪能參與 HIV 病患的供應鏈。

  • We are making remarkable progress at Codexis and momentum is increasing in 2026. We are proud of the advances we are making to further enhance the utility of the ECO Synthesis platform. We look forward to showing our customers and investors additional tangible proof of value of the technology.

    我們在 Codexis 取得顯著進展,且在 2026 年動能持續增強。我們為持續提升 ECO Synthesis 平台的實用性所取得的進展感到自豪。我們期待向客戶與投資人展示更多該技術價值的具體證明。

  • Now to update you on our commercial activities and progress, let me turn it over to Britton.

    接下來為各位更新我們的商業活動與進展,我把電話交給 Britton。

  • Britton Jimenez - Senior Vice President, Sales and Marketing

    Britton Jimenez - Senior Vice President, Sales and Marketing

  • Thanks, Alison. Our ECO Synthesis manufacturing platform continues to mature into a thriving and successful business. Most importantly, it is a platform capable of broadly supporting product development for the most important growing modality in the genomic medicine space. The number of RNA medicines in development is growing at an estimated rate of at least 10% per year with over 100 candidates in clinical trials and more than 400 in preclinical development.

    謝謝,Alison。我們的 ECO Synthesis 製造平台持續成熟,正發展為一項蓬勃且成功的業務。最重要的是,該平台能夠廣泛支援基因體醫療領域中最重要且成長最快的治療模式之產品開發。目前在研發中的 RNA 藥物數量估計每年至少以 10% 的速度成長,臨床試驗中超過 100 個候選藥物,臨床前開發中超過 400 個。

  • Current production technologies will not be able to keep up with future demand. For example, there are four drugs in late-stage clinical development for cardiovascular indications. A 2% to 3% market penetration of one of these therapeutics into a 25 million addressable patient population will require more oligonucleotide production than the entire rare disease portfolio combined.

    現行的生產技術將無法滿足未來需求。例如,有四款藥物正針對心血管適應症進行後期臨床開發。若其中一項療法在 2,500 萬可觸及病患族群中達到 2% 至 3% 的市場滲透率,其所需的寡核苷酸產量將超過整個罕見疾病產品組合的總和。

  • The impact of these powerful new therapies may not reach their full potential if they cannot be produced reliably, efficiently and scale and at scale. As innovators and CDMOs search for ways to expand capacity, the importance of new production technologies is rapidly accelerating, and this market is currently estimated to be at $2 billion.

    若無法以可靠、高效率且可擴大規模的方式生產,這些強大的新療法可能無法充分發揮其全部潛力。隨著創新藥廠與 CDMO 尋求擴充產能的方法,新型生產技術的重要性正快速提升,而目前估計此市場規模約為 20 億美元。

  • For our ECO Synthesis platform, we have over 50 opportunities in our sales pipeline with 40 individual companies demonstrating strong continued interest in our technology. The valuation work with our CDMO partners is progressing and long-term commercial discussions are also moving forward. The industry knows there needs to be a change, and we intend to be the best option for both drug innovators and CDMOs.

    就我們的 ECO Synthesis 平台而言,我們的銷售管線中有超過 50 個機會,且有 40 家公司持續展現對我們技術的強烈興趣。我們與 CDMO 夥伴的價值評估工作正在推進,長期商業合作的討論也在持續向前。產業已經知道必須改變,而我們打算成為藥物創新者與 CDMO 的最佳選擇。

  • In connection with what Alison mentioned before, our customers are interested in exploring how stereoisomer control can be incorporated into their products. We believe this new capability can improve product purity and potency for therapeutics. We are excited to add this approach to our ECO Synthesis portfolio.

    就 Alison 先前提到的內容而言,我們的客戶有興趣探索如何將立體異構體控制納入其產品中。我們相信這項新能力可提升治療用產品的純度與效力。我們很高興將此方法納入我們的 ECO Synthesis 產品組合。

  • In advance of the TIDES USA meeting, we completed exciting new data on stereochemistry. This groundbreaking presentation will underscore the breadth of our leadership in enzymatic technology. During TIDES, we will host a roundtable discussion with industry experts focused on stereochemistry and the value it can bring to next-generation RNA medicines. We will have additional presentations on environmental sustainability and the performance of highly engineered ligases.

    在 TIDES USA 會議之前,我們完成了令人振奮的立體化學新數據。這場突破性的簡報將凸顯我們在酵素技術領域領導地位的廣度。在 TIDES 期間,我們將與產業專家主持一場圓桌討論,聚焦立體化學以及其可為下一代 RNA 藥物帶來的價值。我們也將就環境永續性以及高度工程化連接酶的表現進行其他簡報。

  • Turning to our small molecule biocatalysis business. It remains stable and profitable. We continue to support 13 commercially approved products that are dependent on our enzymes. As we mentioned on a previous update call, we have a number of projects in clinical development. In the last six months, we have had data readouts on three studies, two of which were positive and one of which received FDA approval last month.

    接著談到我們的小分子生物催化業務。該業務仍然穩定且具獲利能力。我們持續支援 13 項已獲商業核准、且依賴我們酵素的產品。如同我們在先前的更新電話會議中提到的,我們有多個處於臨床開發階段的專案。在過去六個月中,我們在三項研究上取得數據讀出,其中兩項為正面結果,另有一項於上月獲得 FDA 核准。

  • We are assisting our customers with preparation for commercial launch for both programs. Our pipeline remains robust with 11 programs still in Phase III clinical development and data readouts expected on 4 clinical trials in the next 12 months.

    我們正協助客戶為兩個計畫的商業上市做準備。我們的產品線仍然強勁,仍有 11 個計畫處於第三期臨床開發階段,並預期在未來 12 個月內有 4 項臨床試驗將進行數據讀出。

  • We are excited for our prospects in 2026 and beyond. The next three years represent a critical window to increase global oligonucleotide production capacity. The industry must confront the challenge of scaling from manufacturing less than 1 metric ton of oligonucleotide therapeutics annually to 10x to 50x that in the next decade. There isn't a more important time for enzymatic production approaches to be deployed in global production infrastructure, and we are driving the ECO Synthesis platform toward this opportunity.

    我們對 2026 年及之後的前景感到振奮。未來三年是提升全球寡核苷酸產能的關鍵窗口。產業必須面對擴產挑戰:從每年生產不到 1 公噸的寡核苷酸治療藥物,於未來十年提升至其 10 倍到 50 倍。現在正是將酵素生產方法部署到全球生產基礎設施中最重要的時刻,而我們正推動 ECO Synthesis 平台把握此一機會。

  • With that, I will now turn the call over to Georgia for a discussion of our financial results for the first quarter.

    接下來,我將把電話會議交給 Georgia,請她說明我們第一季的財務結果。

  • Georgia Erbez - Chief Financial Officer, Chief Business Officer

    Georgia Erbez - Chief Financial Officer, Chief Business Officer

  • Thanks, Britton. Good afternoon, everyone. Today, I will provide a brief overview of our financial results here on the call and invite you to review our 10-Q filed today for a more detailed discussion.

    謝謝你,Britton。各位下午好。今天我將在電話會議中簡要概述我們的財務結果,並邀請各位查閱我們今日提交的 10-Q,以獲得更詳細的討論。

  • Total revenues were $15.2 million for the first quarter of 2026 compared to $7.5 million in the first quarter of 2025. The increase was primarily due to revenue from the Merck technology transfer agreement executed in the fourth quarter of 2025, which has now been fully recognized.

    2026 年第一季總營收為 1,520 萬美元,較 2025 年第一季的 750 萬美元增加。增加主要來自於我們在 2025 年第四季簽署的 Merck 技術移轉協議所帶來的收入,該收入現已全數認列。

  • Product gross margin was 71% for the first quarter of 2026, which compares to 55% for the first quarter of 2025. For the first quarter of 2026, the increase was primarily driven by product mix and sales declines in several low-margin products that were replaced with more profitable product sales. We continue to expect 2026 annual gross margins to be comparable to the annual levels we reported in 2025.

    2026 年第一季產品毛利率為 71%,相較於 2025 年第一季的 55%。2026 年第一季的提升主要由產品組合所驅動,且若干低毛利產品銷售下滑,並由更高獲利的產品銷售所取代。我們仍預期 2026 年全年毛利率將與我們在 2025 年所報告的全年水準相當。

  • Research and development expenses for the first quarter of 2026 were $11.4 million compared to $12.9 million in the first quarter of 2025, largely driven by lower allocable costs that were partially offset by higher employee-related costs and higher use of outside services.

    2026 年第一季研發費用為 1,140 萬美元,較 2025 年第一季的 1,290 萬美元下降,主要因可分攤成本較低,但部分被較高的員工相關成本以及較多外部服務使用所抵銷。

  • Selling, general and administrative expenses were $9.8 million in the first quarter of 2026 compared to $12.4 million in the prior year period. The decrease was primarily due to lower employee-related costs due to lower headcount, lower stock-based compensation expenses and lower consultant fees and outside services.

    2026 年第一季銷售、一般及行政費用為 980 萬美元,較去年同期的 1,240 萬美元下降。下降主要由於人員編制較少導致員工相關成本降低、以股份為基礎的薪酬費用降低,以及顧問費與外部服務費用降低。

  • Net loss for the first quarter of 2026 was $8.7 million compared to the loss of $20.7 million for the first quarter of 2025. We are fully engaged in our project to retrofit our new GMP plant and located in Hayward, California that was leased in 2025. We are currently in the detailed design phase and are preparing to apply for a building permit in the second quarter. Construction is planned to get underway in the second half of the year, and we expect to be fully operational by the end of 2027.

    2026 年第一季淨損為 870 萬美元,較 2025 年第一季的 2,070 萬美元淨損縮小。我們正全力投入改造我們於 2025 年租賃、位於加州海沃德(Hayward)的新 GMP 廠房之專案。目前我們處於詳細設計階段,並準備在第二季申請建築許可。工程計畫於下半年動工,並預期在 2027 年底前全面投入營運。

  • Together with our Redwood City headquarters, this marks a continued step forward in how we support development, scale-up and manufacturing our customers' products. We reiterate our revenue guidance and expect 2026 revenue in the range of $72 million to $76 million. Like the quarterly trends we saw last year, we expect 2026 revenue to be more heavily weighted towards the second half of 2026 versus the first half.

    結合我們位於 Redwood City 的總部,這標誌著我們在支援客戶產品的開發、放大與製造方面持續向前邁進。我們重申營收指引,並預期 2026 年營收將落在 7,200 萬至 7,600 萬美元之間。如同去年所見的季度趨勢,我們預期 2026 年營收將較偏重於 2026 年下半年,而非上半年。

  • Codexis ended the first quarter with $65.1 million in cash, cash equivalents and short-term investments, which compares to $78.2 million at the end of 2025. We expect our current cash will be sufficient to fund our planned operations and capital expenditures through the end of 2027. As a reminder, our financial guidance and cash runway include the expenses associated with the build-out of our GMP facility.

    Codexis 於第一季末持有現金、約當現金及短期投資合計 6,510 萬美元,相較於 2025 年底的 7,820 萬美元。我們預期目前的現金足以支應我們規劃的營運與資本支出至 2027 年底。提醒各位,我們的財務指引與現金可支應期間已包含 GMP 設施建置相關費用。

  • With that, I will now turn the call back over to Alison.

    接下來,我將把電話會議交回給 Alison。

  • Alison Moore - Executive Vice President, Chief Technical Officer

    Alison Moore - Executive Vice President, Chief Technical Officer

  • Thank you, Georgia, and thank you, Britton. Our proprietary ECO Synthesis platform technology has the potential to radically alter the landscape of oligonucleotide manufacturing. The next step for Codexis is to deploy the technology into our customers' pipelines. We are working hard to achieve this goal in 2026.

    謝謝你,Georgia,也謝謝你,Britton。我們專有的 ECO Synthesis 平台技術有潛力徹底改變寡核苷酸製造的版圖。Codexis 的下一步是將該技術部署到客戶的產品線中。我們正努力在 2026 年達成此目標。

  • For investors, we want to show proof of success. We can do this by signing broader and higher value types of contracts as well as innovative licensing deals. We will also be focused on financial performance by meeting our revenue targets while being mindful of our expenses.

    對投資人而言,我們希望展現成功的證據。我們可以透過簽署更廣泛且更高價值類型的合約,以及創新的授權交易來達成。我們也將專注於財務表現:在留意費用的同時達成我們的營收目標。

  • We will continue to innovate in the field of RNA medicines using our skills and experience in biocatalytic enzymes. Our presentations at the TIDES USA meeting next week in Boston will showcase our newest innovation. We are continuing to scale up our ECO Synthesis manufacturing platform, and we are making progress towards achieving 0.5 kilogram scale by the end of this year.

    我們將持續運用在生物催化酵素方面的技能與經驗,在 RNA 藥物領域推動創新。我們下週在波士頓舉行的 TIDES USA 會議上的簡報將展示我們最新的創新成果。我們正持續擴大 ECO Synthesis 製造平台的規模,並在今年底前朝達成 0.5 公斤規模的目標取得進展。

  • I believe 2026 could be the year when ECO Synthesis is no longer viewed as just an alternative production technology, but the technology of choice for our customers' RNA medicines. We are excited by our prospects and proud of the dedication and achievements of our employees who have been instrumental in making the ECO Synthesis technology a reality.

    我相信 2026 年可能會是 ECO Synthesis 不再僅被視為替代性生產技術,而是成為客戶 RNA 藥物首選技術的一年。我們對前景感到振奮,也為員工的投入與成就感到自豪;他們在讓 ECO Synthesis 技術成為現實的過程中扮演了關鍵角色。

  • Now we'd be happy to take your questions. Operator?

    現在我們很樂意回答各位的提問。接線員?

  • Operator

    Operator

  • (Operator Instructions) Allison Bratzel, Piper Sandler.

    (接線員指示) Allison Bratzel,Piper Sandler。

  • Peter Spanogiannopoulos - Analyst

    Peter Spanogiannopoulos - Analyst

  • This is Peter Spanogiannopoulos on for Allison. I was wondering if you can give us a preview of what to expect from the upcoming stereochemistry data that will be presented at TIDES. Then as a follow-up, I'm wondering when we can expect to see some data demonstrating that this stereo control translates to improved efficacy.

    我是代替 Allison 的 Peter Spanogiannopoulos。我想請問,您是否能先預告一下即將在 TIDES 發表的立體化學數據,我們可以期待看到什麼?接著追問一下,我想了解我們何時能看到一些數據,證明這種立體控制能轉化為更佳的療效。

  • Alison Moore - Executive Vice President, Chief Technical Officer

    Alison Moore - Executive Vice President, Chief Technical Officer

  • Thanks for the question, Peter. Yes, we're very excited to show our data next week. What we are going to show for the first time demonstrates stereo control at both the three prime and the five prime end of the siRNA molecule. This has not been shown before, and we will show data describing how we achieve that and the product quality of the product.

    謝謝你的問題,Peter。是的,我們非常期待在下週展示我們的數據。我們將首次展示的內容,證明在 siRNA 分子的 3' 端與 5' 端都能做到立體控制。這在過去尚未被展示過;我們也會提供數據說明我們如何達成,以及該產品的產品品質。

  • We are currently working on generating data associated with the potential for improved activity. We have some data already and shortly, we are going to have more. I would also point out that there is some extremely nice published literature that has already demonstrated the opportunity of stereo control in siRNA medicine. That stereo control confers improved stability related to intracellular nuclease activity. Even mechanistically, there's a hypothesis about why there ought to be the opportunity of improved potency.

    我們目前正在產生與潛在活性提升相關的數據。我們已經有一些數據,且很快會有更多。我也想指出,已有一些非常優秀的已發表文獻,已經證明在 siRNA 藥物中進行立體控制的機會。該立體控制可帶來更佳的穩定性,與細胞內核酸酶活性相關。甚至在機制層面,也有一個假說解釋為何應該存在提升效力(potency)的機會。

  • As I said, we have those data in the works, and we will definitely be sharing those when we have them also.

    如我所說,我們正在進行這些數據的產出,等我們取得後也一定會分享。

  • Operator

    Operator

  • Kristen Kluska, Cantor Fitzgerald.

    Kristen Kluska,Cantor Fitzgerald。

  • Unidentified Participant

    Unidentified Participant

  • This is Ian on the line for Kristin. Could you speak at a high level about the risks that are involved in scaling the platform from 100-gram scale to like 500 gram by year-end? Now that you're operating at 100 gram, what aspects of the scale-up process do you believe have been derisked versus what remains to be proven?

    我是代替 Kristin 的 Ian。您能否從較高層次談談,將平台從 100 克規模擴大到例如年底前 500 克規模所涉及的風險?現在你們已在 100 克規模運作,您認為放大過程中哪些面向已經降風險(derisked),相較之下哪些仍有待驗證?

  • Alison Moore - Executive Vice President, Chief Technical Officer

    Alison Moore - Executive Vice President, Chief Technical Officer

  • Thank you for the question. We have a very skilled and experienced process development team here at Codexis that we have built over the last three years that have expertise both in traditional oligonucleotide synthesis who -- some of whom are enzymeologists and some of whom are what I would call more classic process development individuals. Together, they're working really well on stepping through the scale changes, which are often 5x to 10x scale changes every time we scale the process.

    謝謝你的問題。Codexis 在過去三年建立了一支非常熟練且經驗豐富的製程開發團隊,具備傳統寡核苷酸合成方面的專業;其中有些人是酶學專家(enzymeologists),也有些人是我所稱較典型的製程開發人員。他們協作得非常好,逐步推進每次放大時常見的 5 倍到 10 倍規模變更。

  • I think you may be aware, we started with a very lab scale process. Now we are at a scale where we can certainly deliver material for preclinical development and very shortly approaching the ability to deliver kilo scale. I mentioned that our goal is to achieve half kilo scale by the end of the year. Twofold from there will be much more straightforward.

    我想你可能知道,我們一開始是非常實驗室規模的製程。現在我們已達到一個規模,當然可以提供臨床前開發所需的材料,並且很快就會接近能夠提供公斤級(kilo scale)的能力。我提到過,我們的目標是在年底前達到半公斤規模。從那之後,後續的放大將會更為直接。

  • The kinds of challenges that we're meeting during scale-up are what, I would call, normal process development challenges. Those are often the challenges of control of temperature, flow rates, etc., as we start to use larger and larger equipment. We are learning a lot about how to scale the process. I think that is part of the secret sauce that manufacturing technology companies start to accumulate. We continue to deliver products of higher and higher quality actually, and that's what matters at the end of the day.

    我們在放大過程中遇到的挑戰,我會稱之為正常的製程開發挑戰。當我們開始使用越來越大型的設備時,這些挑戰通常包括溫度、流速等控制問題。我們正在學到很多關於如何放大該製程的方法。我認為這也是製造技術公司逐步累積的「秘訣」(secret sauce)之一。實際上,我們持續交付品質越來越高的產品,而這才是最終最重要的。

  • Operator

    Operator

  • Matt Hewitt, Craig-Hallum.

    Matt Hewitt,Craig-Hallum。

  • Matthew Hewitt - Analyst

    Matthew Hewitt - Analyst

  • Congratulations on the strong start to the year. Maybe first up, regarding the Merck enzyme, I'm just curious, historically, those have been talked or discussed as being kind of $5 million to $10 million in annual revenues. I'm just curious where this one kind of fits into that and how we should be thinking about the ramp of that specific product this year?

    恭喜今年開局強勁。首先,關於 Merck 的酶產品,我只是好奇,過去歷來這類產品常被提到或討論為每年約 500 萬到 1,000 萬美元的營收。我想了解這一項大概落在那個區間的哪個位置,以及我們今年應該如何看待這個特定產品的爬坡(ramp)?

  • Georgia Erbez - Chief Financial Officer, Chief Business Officer

    Georgia Erbez - Chief Financial Officer, Chief Business Officer

  • It's a brand-new approval for us, and we are very excited by this. We are working with Merck right now as we work through their demand for the product moving forward. We hope to have more information for you in future calls. Right now, we're working with them on their supply chain and their demand on manufacturing moving forward. Stay tuned, and we'll hopefully have some more information for you in future calls.

    這對我們而言是全新的核准,我們對此非常興奮。我們目前正與 Merck 合作,釐清他們未來對該產品的需求。我們希望在未來的電話會議中能提供更多資訊。目前我們正與他們就其供應鏈,以及未來製造端的需求進行協作。敬請期待,我們希望在後續的電話會議中能提供更多資訊。

  • Matthew Hewitt - Analyst

    Matthew Hewitt - Analyst

  • Then maybe separately, the ongoing engagement that you have with the FDA regarding the ECO Synthesis platform, maybe an update on how those conversations are progressing? What will be the ultimate outcome from those discussions? Does it allow for faster approval with potential partnerships down the line? Or just explain what this will ultimately lead to?

    另外,關於你們與 FDA 就 ECO Synthesis 平台持續互動的部分,能否更新一下這些對話的進展?這些討論最終會產生什麼結果?是否能讓未來潛在合作夥伴的核准更快?或請說明這最終會帶來什麼?

  • Alison Moore - Executive Vice President, Chief Technical Officer

    Alison Moore - Executive Vice President, Chief Technical Officer

  • Thanks, Matt. That's a great question. We're actually right now working on a briefing for our next interaction with the agency, which we are planning for in approximately a quarter. Codexis was accepted into the emerging technologies program in 2024. We have been engaged with the agency around the ECO Synthesis manufacturing platform in various conversations since then. The upcoming conversation that we will be having is an ongoing part of that program.

    謝謝,Matt。這是個很好的問題。我們目前正在準備下一次與主管機關互動的簡報,預計大約在一個季度後進行。Codexis 已於 2024 年被納入新興技術計畫(emerging technologies program)。自那之後,我們就 ECO Synthesis 製造平台已與主管機關進行了多次不同形式的交流。我們即將進行的對話,是該計畫持續推進的一部分。

  • In addition to the emerging technologies program, we are working to put together the foundational information that is required to make a submission towards an Advanced Manufacturing Technologies designation. It's called the AMT designation. If and when we achieve that designation, that does enable faster timing on review times and the potential for accelerated approval.

    除了新興技術計畫之外,我們也正在彙整申請「先進製造技術」認定所需的基礎資訊。這稱為 AMT 認定(AMT designation)。如果以及當我們取得該認定時,確實能縮短審查時間,並具備加速核准的可能性。

  • Operator

    Operator

  • Matt Stanton, Jefferies.

    Matt Stanton,Jefferies。

  • Matthew Stanton - Analyst

    Matthew Stanton - Analyst

  • Maybe one on the CDMO partnership side. It sounds like the goal is to commence another strategic partnership by the end of '26, which is good to see. Would love to just get an update on the three existing CDMO partnerships you have now that it's been a few quarters, any proof points, learnings, next steps? How do you think about some of those original partnerships being able to engage more meaningfully towards contracts, revenue, things like that over time?

    我想問一個關於 CDMO 合作夥伴的問題。聽起來目標是在 2026 年底前再啟動另一項策略性合作夥伴關係,這點很高興看到。也想請你更新一下目前既有的三個 CDMO 合作夥伴關係:現在已過了幾個季度,有沒有任何佐證(proof points)、學習心得、下一步?你們如何看待這些最初的合作夥伴關係,隨時間推進能更有意義地走向合約、營收等?

  • Britton Jimenez - Senior Vice President, Sales and Marketing

    Britton Jimenez - Senior Vice President, Sales and Marketing

  • Yes. Absolutely. The partnerships we have with the CDMOs that we've announced are going fantastic. The engagement with the different CDMOs around our technology, then getting a better understanding of our technology, how it works, how it scales, like I said, have just been fantastic. Everyone's been extremely pleased with the results of that.

    是的。當然。我們已宣布的 CDMO 合作夥伴關係進展非常順利。各家 CDMO 與我們就技術進行互動,並更深入理解我們的技術、其運作方式與如何放大,如我所說,整體都非常出色。大家對這些成果都非常滿意。

  • Because of the great work of the teams on both here within Codexis and within those partnerships, that has allowed for us to advance our commercial discussions. We're in progress of those discussions. Everything is looking very, very positively. We're looking forward to what lies ahead of us because we do believe there's a great path in front of us.

    由於 Codexis 內部團隊以及合作夥伴團隊的出色工作,這也讓我們得以推進商業層面的討論。我們正在進行這些討論。一切看起來都非常、非常正面。我們也期待接下來的發展,因為我們確實相信前方有一條很好的道路。

  • As for other potential CDMO partners, absolutely, we're always evaluating the marketplace because we want to ensure that the availability of our technology is out there for our customers, the drug innovators to be able to get access to the technology. It's an exciting time. These partners are critical to our strategy. It opens the doors and allows for bigger and better opportunities for us because it's another pathway for us. Great things going there.

    至於其他潛在的 CDMO 合作夥伴,當然,我們一直在評估市場,因為我們希望確保我們的技術能在市場上供客戶使用,讓藥物創新者能夠取得並使用這項技術。這是一個令人振奮的時刻。這些合作夥伴對我們的策略至關重要。它為我們打開大門,讓我們能夠獲得更大、更好的機會,因為這是我們的另一條途徑。那邊進展得很不錯。

  • Matthew Stanton - Analyst

    Matthew Stanton - Analyst

  • Then maybe just on the broader pipeline. It sounds like a lot of progress. You talked about a licensing deal with a major pharma company, hopefully in the back half of '26 year. Just any more flavor you can provide? Is that kind of one that you're working on, you think hits?

    那麼也許談談更廣泛的研發管線。聽起來進展很多。你提到希望在 2026 年下半年與一家大型製藥公司達成授權交易。你能再多提供一些細節嗎?這算是你們正在推進、你認為有機會落地的一筆嗎?

  • Do you have a couple of opportunities and you're assuming one of them comes through? Would love just a little more color on that. Then anything you can provide in terms of the scope or shape of what that could look like? Is it early-stage work? Is there any chance that you could be looking at running in parallel on clinical pipeline programs?

    你們是否有幾個機會在手上,並假設其中一個會成功?很希望能再多了解一點。另外,就其可能的範圍或形式,你能提供任何資訊嗎?是早期階段的工作嗎?是否有可能你們會在臨床管線專案上並行推進?

  • Just any more flavor in terms of the pipeline there and what that could look like over time?

    就那邊的管線以及隨時間推移可能呈現的樣貌,能否再多補充一些?

  • Britton Jimenez - Senior Vice President, Sales and Marketing

    Britton Jimenez - Senior Vice President, Sales and Marketing

  • Yes. There's definitely a lot of conversations happening around that. There's multiple opportunities that sit in front of us with bigger and broader partnerships. Those discussions have very different flavors to them because each of those organizations are looking at our technology in different ways. I'd say the discussions are ongoing.

    是的。確實有很多相關對話正在進行。我們面前有多個機會,涉及更大型、更廣泛的合作夥伴關係。這些討論的性質各不相同,因為每個組織看待我們技術的方式都不一樣。我會說討論仍在持續進行中。

  • They're looking positive. I can't get into a lot of details around this right now just because of the types of conversations we're having. No, we're very optimistic about this. The excitement around this technology and the data that we're presenting just further enhances the value out there in the marketplace. I'd say great conversations, but still more to come here in the future.

    看起來是正面的。我現在無法深入談太多細節,主要是因為我們正在進行的對話類型所致。不過,我們對此非常樂觀。市場對這項技術的興奮程度,以及我們所呈現的數據,都進一步提升了其在市場上的價值。我會說對話很棒,但未來還會有更多進展。

  • Operator

    Operator

  • (Operator Instructions) Brendan Smith, Cowen and Company.

    (接線員指示) Brendan Smith,Cowen and Company。

  • Brendan Smith - Analyst

    Brendan Smith - Analyst

  • I just wanted to ask in terms of the sales funnel. Obviously, a lot of breadth here, but could you give a little more color on breakdown of out of those 40 companies, what's the mix between like large pharma, larger biotech and emerging biotech? Then maybe in terms of the 55 programs, could you just speak to which are maybe further along than others relative to each other?

    我想就銷售漏斗方面請教一下。顯然覆蓋面很廣,但你能否就那 40 家公司做個拆分,說明大型藥廠、較大型生技公司與新興生技公司的比例大概如何?另外就 55 個專案而言,你能否談談哪些相對其他專案進度更靠前?

  • Britton Jimenez - Senior Vice President, Sales and Marketing

    Britton Jimenez - Senior Vice President, Sales and Marketing

  • Yes. No problem. Regarding the organizations, the funnel is very, very healthy. Why I say that is our conversations cover across that entire spectrum that you mentioned. We're talking to some of the largest drug innovators in the RNAi space.

    可以。沒問題。就這些組織而言,漏斗非常、非常健康。我之所以這麼說,是因為我們的對話涵蓋了你提到的整個光譜。我們正在與 RNAi 領域一些最大的藥物創新者洽談。

  • We're talking down to some cell companies. The size and shape is very different, which is fantastic because it gives us diversification within the platform, the technologies. We're derisking the conversations. We're not in one just specific market segment, which is great.

    我們也在與一些細胞公司洽談。規模與型態差異很大,這非常好,因為它讓我們在平台與技術上具備多元化。我們也在降低這些對話的風險。我們不只侷限於單一特定的市場區隔,這很棒。

  • Now of course, in those conversations, like I mentioned, those organizations have different ideas on how they want to engage with us using our ECO Synthesis platform. Each of those conversations are unique and a little different on what we're trying to accomplish.

    當然,在這些對話中,如我提到的,這些組織對於如何使用我們的 ECO Synthesis 平台與我們合作,各自有不同想法。每一段對話都很獨特,且在我們想達成的目標上也略有不同。

  • In regards to the programs, again, there is no one size fit all. People are talking to us about everything from very early-stage assets to clinical assets to commercial assets and everything in between. I can't sit here and say we only talk about one thing because there is a very good diversification within our conversations, which is really exciting.

    至於專案方面,同樣地,並沒有一體適用的模式。大家與我們討論的範圍從非常早期的資產,到臨床資產、商業化資產,以及介於其間的各種情況。我無法坐在這裡說我們只談某一件事,因為我們的對話本身就具有非常好的多元化,這真的令人振奮。

  • Brendan Smith - Analyst

    Brendan Smith - Analyst

  • I guess a large part of the thesis, obviously, has been the broader demand outstripping existing supply. Maybe with this technical differentiation, are you viewing even some smaller indications and maybe more niche programs as potential opportunities from an asset differentiation standpoint? Are there any other ways that you view are technically feasible beyond just this upcoming TIDES presentation, which we're looking forward to?

    我想你們投資論點的一大部分,顯然是更廣泛的需求超過既有供給。那麼在這種技術差異化之下,你們是否也把一些較小適應症、可能更利基的專案,視為從資產差異化角度來看的潛在機會?除了即將到來、我們很期待的 TIDES 發表之外,你們還認為有哪些在技術上可行的方向?

  • Alison Moore - Executive Vice President, Chief Technical Officer

    Alison Moore - Executive Vice President, Chief Technical Officer

  • Yes. As Britton just stated, at the moment -- so just to be clear, we have existing work and existing contracts with some very large pharmaceutical companies and with innovator and stealth companies for the ECO Synthesis manufacturing platform. We are very open to what folks might like to use the platform for at the moment.

    是的。如 Britton 剛才所說,目前——為了說清楚——我們已經就 ECO Synthesis 製造平台,與一些非常大型的製藥公司,以及創新公司與隱身公司(stealth companies)有既有工作與既有合約。就目前而言,我們對大家想用這個平台做什麼都非常開放。

  • Since we're really just starting to show the data and show real evidence of the product quality associated with the opportunity of stereo control, I expect that we probably will get some more inbound interest there. We certainly will be interested to work with a variety of customers there. We don't have unlimited bandwidth. Actually, just right at the moment, we are working on improving productivity and throughput so that we can make sure that we have the right kind of velocity and capacity to meet those customers' demands. I suppose, maybe, Brandon, your question is, at the end of the day, if there would be a high-volume client or a client with high volume potential, we would prioritize that client.

    由於我們才剛開始展示數據,並提供與立體控制機會相關的產品品質之實證,我預期我們可能會收到更多主動洽詢的興趣。我們當然也有興趣與各類客戶合作。但我們的產能與人力並非無上限。事實上,就在目前,我們正致力於提升生產力與產出吞吐量,以確保我們具備適當的速度與產能來滿足客戶需求。我想,Brandon,你的問題也許是:歸根結底,如果有高用量客戶或具有高用量潛力的客戶,我們會優先考慮該客戶。

  • Operator

    Operator

  • Thank you. At this time, I would like to turn it back to Alison Moore for closing remarks.

    謝謝。此時,我想把時間交回給 Alison Moore 作結語。

  • Alison Moore - Executive Vice President, Chief Technical Officer

    Alison Moore - Executive Vice President, Chief Technical Officer

  • Thank you, everyone, for joining us today, and we will certainly be looking forward to seeing some of you at upcoming investor conferences. If at any time you have additional questions, please feel free to contact us. I hope you have a good afternoon and evening. Thank you.

    謝謝各位今天加入我們,我們也非常期待在接下來的投資人會議上見到各位中的一些人。若你在任何時候有其他問題,歡迎隨時與我們聯繫。祝各位下午與晚上愉快。謝謝。

  • Operator

    Operator

  • Thank you. This does conclude today's teleconference. You may disconnect your lines at this time, and thank you for your participation, and have a great day.

    謝謝。今天的電話會議到此結束。你現在可以掛斷電話線,感謝你的參與,祝你有美好的一天。