Co-Diagnostics (CODX) 2026 年第二季法說會：FDA 遞件取得進展，惟現金下滑

重點總覽

• 2026 財年第二季營收為 16.6 萬美元，去年同期為 16.3 萬美元。 毛利自 13.1 萬美元下降至約 12.1 萬美元。
• 營運費用自 820 萬美元降至 630 萬美元，主要受惠於一般及行政費用、研發費用、法律費用、人事費用與股票薪酬費用減少。
• 淨虧損自 770 萬美元（基本與稀釋後每股虧損 7.00 美元）收窄至 630 萬美元（基本與稀釋後每股虧損 1.46 美元）。調整後 EBITDA 虧損自 720 萬美元改善至 580 萬美元。
• Co-Diagnostics 已就其在 Co-Dx PCR 平台上的 A 型流感、B 型流感及 RSV 檢測，向美國 FDA 提交 510(k) 和 CLIA 豁免雙重申請。
• 現金及現金等價物自 2025 年底的 1,190 萬美元降至 360 萬美元。管理層預期短期內將持續出現營運虧損，並計劃評估股權、債務、戰略交易、合作夥伴關係及非稀釋性資金等融資途徑。
• 該公司預計於 2026 年底前向印度 CDSCO 提交肺結核項目申請，並視資格與時間安排向世界衛生組織（WHO）診斷專家評估小組（ERPD）提出申請。

核心財務數據

業務與營運表現

上呼吸道項目取得重大法規里程碑。Co-Diagnostics 已完成分析與臨床性能研究，以支持向美國 FDA 提交 Co-Dx PCR 平台上的 A 型流感、B 型流感及 RSV 檢測申請。

分析項目包含 27 項研究，並在 PCR Pro 上進行了超過 10,000 次 PCR 測試。臨床研究在美國 9 個試驗中心招募了 1,400 多名有症狀患者。該公司隨後向 FDA 提交了 510(k) 與 CLIA 豁免雙重申請。該平台及相關檢測仍處於法規審查階段，目前尚未上市銷售。

在印度，CoSara PCR Pro 儀器與 CoSara PCR MTB 檢測的臨床研究正在推進。Co-Diagnostics 表示，其合資企業 CoSara 提供在地化製造、法規專業知識與商業化基礎設施。ERPD 評估所需的某些驗證成本主要由非政府組織 (NGO) 夥伴贊助。

該公司還完成了一項利用血漿檢體在 Co-Dx PCR Pro 上進行伊波拉 (Ebola) 檢測的概念驗證研究，這是該儀器的首個血液檢測項目。CoSara 正針對集中式實驗室開發邦迪布育病毒 (Bundibugyo virus) 與全伊波拉檢測，並已回應提供 200 次邦迪布育檢測供第三方評估的需求。

在沙烏地阿拉伯，合資企業 CoMira 正持續進行技術轉移與在地化製造的準備工作。管理層表示，該基礎設施可支持未來拓展至中東與北非地區。

Co-Diagnostics 亦報告 Vector Smart 維持商業推廣動能，在美國防蚊控制區的客戶足跡持續擴大。該業務使客戶能夠在內部進行分子檢測，而無需依賴集中式實驗室。

管理層展望

管理層預期，隨著公司推進臨床項目、法規送審及商業化準備，短期內將持續出現營運虧損。

在肺結核項目方面，Co-Diagnostics 的目標是在 2026 年底前向印度 CDSCO 提交申請，並在符合適用資格要求與時間安排的情況下向世衛組織 (WHO) 的 ERPD 提交申請。

公司計劃維持嚴謹的資本配置，並評估股權或債務融資、戰略交易、合作夥伴關係及政府補助。公司未提供具體的營收或盈利預測。

風險與關注焦點

• 季度末現金及現金等價物為 360 萬美元，低於 2025 年底的 1,190 萬美元。
• 進一步籌集資金可能包括股權融資，從而帶來潛在的股權稀釋風險，不過管理層表示仍會重視股權稀釋與資本效率。
• 目前營收仍屬有限，管理層指出，在此階段成本波動可能會對毛利率產生重大影響。
• Co-Dx PCR 平台及相關檢測在商業銷售前需要取得主管機關的許可或授權。
• FDA、CDSCO 及 ERPD 的審查時間與結果仍具不確定性，並受制於法規要求。

分析師問答重點

管理層確認 Co-Diagnostics 計劃在符合資格與時間要求的前提下，於 2026 年底前提交其肺結核檢測以供 ERPD 評估。

關於伊波拉病毒，執行長 Dwight Egan 將戰略描述為：如果出現檢測需求，公司已準備好進行回應。公司已完成概念驗證工作，並應與印度相關的要求提供了 200 次檢測，但未提供具體的開發或商業化時間表。

法說會完整逐字稿

完整財報電話會議逐字稿

管理層陳述

Operator

Thank you for standing by. At this time, I would like to welcome everyone to the Co-Diagnostics, Inc. Second Quarter 2026 Earnings Webcast. [Operator Instructions] I would now like to turn the conference over to Andrew Benson, Head of Investor Relations. The floor is yours.

Andrew Benson

Good afternoon, everyone. Thank you all for participating in today's conference call. On the line today from Co-Diagnostics, we have Dwight Egan, Chief Executive Officer; and Brian Brown, Chief Financial Officer. Earlier today, Co-Diagnostics released financial results from the second quarter ended June 30, 2026. A copy of the press release is available on the company's website. We will begin with management's prepared remarks and then open up the call to analyst Q&A.

Before we begin, we would like to inform listeners that certain statements made by Co-Diagnostics during this call, which are not historical facts, are forward-looking statements. In addition to diagnostic test developments and clinical evaluation time lines, this includes statements concerning regulatory review and clearance, commercialization plans and timing, international regulatory and manufacturing initiatives, financing and liquidity and the capabilities and potential uses of the company's technology and data infrastructure. The company's Co-Dx PCR testing platform and related tests are subject to regulatory review, clearance or authorization and are not currently for sale.

Actual outcomes and results may differ materially from what is expressed or implied in any statement. Important factors which could cause actual results to differ materially from those in these forward-looking statements are described in the company's annual report on Form 10-K, subsequent quarterly reports on Form 10-Q and other filings with the SEC, including under the heading Risk Factors as well as in today's earnings release. Co-Diagnostics assumes no obligation and expressly disclaims any duty to update any forward-looking statements to reflect events or circumstances occurring after this call or to reflect the occurrence of unanticipated events.

In addition, the company may discuss certain non-GAAP financial measures during today's call. These non-GAAP financial measures should not be considered a replacement for and should be read together with GAAP results. We refer you to the company's earnings release issued shortly before this call, which contains reconciliations to the non-GAAP financial measures presented to their most comparable GAAP results.

At this time, I would like to turn the call over to Co-Diagnostics' Chief Executive Officer, Dwight Egan. Dwight?

Dwight Egan

Thank you, everyone, for joining us today and for your continued support of Co-Diagnostics. This past quarter marked another important step in our transition from platform development toward commercialization. We continue to advance the regulatory, clinical, commercial and technology initiatives that support our long-term growth strategy. Over the past several years, we have invested in building a differentiated molecular diagnostics platform. Recently, those investments have translated into solid execution across our highest strategic priorities.

The milestones we discussed today reflect continued execution against our long-term strategy. As we look ahead, our focus remains centered on advancing regulatory milestones, expanding our global commercial opportunities, enhancing our platform capabilities and positioning the company for commercialization. Taken together, these priorities reflect a business that is increasingly focused on execution and scalability as we move closer to market. With that context, I'd like to begin with our upper respiratory program, where we recently achieved one of the most significant milestones in the company's history.

Our upper respiratory multiplex assay remains one of the company's top strategic priorities and represents an important step toward commercialization of the Co-Dx PCR platform in the United States. Influenza and RSV panels remain key drivers of the seasonal respiratory disease testing market, with a well-established reimbursement code, which we expect will facilitate our go-to-market strategies for point-of-care near-patient locations. As we have discussed previously, bringing the Co-Dx PCR platform to the U.S. market remains a foundational component of our commercialization strategy and creates opportunities well beyond respiratory testing over time.

As the quarter concluded, we announced the successful completion of the analytical and clinical performance studies included in support of our regulatory submission. Our analytical validation program included 27 individual studies and more than 10,000 upper respiratory PCR test runs on the PCR Pro, including multicenter reproducibility studies evaluating performance across operators, sites and instruments.

Our clinical study enrolled more than 1,400 symptomatic patients across 9 geographically diverse clinical sites throughout the United States. More recently, we officially announced the submission of our dual 510(k) and CLIA waiver by application to the FDA for the flu A, B and RSV assay on the Co-Dx PCR platform. This submission represents a major milestone, reflecting years of development, validation and regulatory preparation. We are pleased to have reached this important stage in the regulatory process and look forward to working with FDA during its review of our submission.

To support this submission and our broader regulatory strategy, we recently welcomed Dr. Wes Lindsey as our new Chief Scientific Officer. Wes brings more than 20 years of experience in molecular diagnostics, having led numerous successful FDA submissions and commercial launches. He was specifically recruited to strengthen our scientific organization as we advance the Co-Dx PCR platform through multiple regulatory pathways and expand our product portfolio. We believe his expertise will be an important asset as we continue executing on our regulatory strategy as well as the development of our pipeline of products before potential commercialization in key markets.

Turning to our tuberculosis program. We are making meaningful progress in India as clinical studies advance on the CoSara PCR Pro instrument and CoSara PCR MTB test. As these studies progress, we are targeting additional regulatory milestones later this year, including planned submissions to India's CDSCO and, subject to applicable eligibility requirements and timing, the World Health Organization's Expert Review Panel for Diagnostics, or ERPD. Our work in India builds on nearly a decade of investment through our CoSara joint venture, where we have established manufacturing, regulatory expertise and a growing commercial presence. We believe this provides a distinct competitive advantage as we prepare for commercialization, and we are encouraged by the progress being made.

India is one of the world's largest single country tuberculosis markets and represents an important commercial opportunity for the company, but the African region continues to bear a substantial share of the global TB burden, making expanded access to rapid molecular diagnostics for TB an important public health priority. The aim of the WHO's ERPD mechanism is to streamline access to innovative state-of-the-art IVDs that meet the highest standards of quality, but that are still proceeding through the full WHO prequalification process, which is considerably more time intensive. A favorable ERPD assessment allows diagnostics manufacturers to list the outcome of the assessment on their website, including indicating that the diagnostic is considered part of the Global Fund list of eligible IVDs, which greatly facilitates the procurement process for IVDs in countries like those in Africa that are highly burdened by specific diseases.

Certain costs associated with the analytical and clinical study validations required to secure an ERPD assessment are largely being supported by our NGO partner relationships, which we believe underscores the urgent need for high-quality point-of-care TB diagnostics. During the quarter, we were invited to participate as a manufacturer partner at the UNOPS Global Implementation Workshop on near point-of-care TB diagnostics in Bangkok. Along with national TB programs, researchers, donors and technical agencies representing 21 countries, we believe this invitation reflects growing international recognition of both our platform and our approach to decentralized molecular diagnostics.

Recent WHO guidance recommending near point-of-care molecular testing, including tongue swab sampling, aligns closely with the design of our platform and our MTB assay. We continue to believe the convergence of this WHO guidance, CoSara's commercial infrastructure and our domestic manufacturing capability and capacity create a compelling path to market in the world's highest need regions.

Beyond tuberculosis, we are expanding the capabilities of the Co-Dx PCR platform across additional disease applications. Earlier this quarter, following the World Health Organization's declaration of a public health emergency for Ebola, our CoSara team rapidly advanced development activities supporting Bundibugyo virus detection. We also successfully completed a proof-of-concept study for an Ebola assay with direct from plasma as a sample type on the Co-Dx PCR Pro instrument. This is our first blood-based assay designed for the Co-Dx PCR Pro, demonstrating the flexibility of the platform beyond traditional swab-based infectious disease testing. We believe this proof of concept demonstrates the potential expansion of addressable applications of the Co-Dx PCR platform by extending its capabilities beyond traditional respiratory and swab-based testing.

Our partners at CoSara have also continued their development of Bundibugyo virus and a pan-Ebola test for centralized laboratories, and their foresight in developing this product allowed them to quickly respond to a recent request by the India's Center for Cellular and Molecular Platforms, or C-CAMP, for 200 Bundibugyo tests to be evaluated by a third-party laboratory. As our diagnostic portfolio grows, we are also expanding the digital infrastructure that supports the platform. We have invested in a connected ecosystem designed to combine molecular diagnostics, a mobile application and secure cloud-based infrastructure while we continue to develop and evaluate AI-enabled capabilities into a single integrated platform.

This architecture was intentionally designed to extend beyond the diagnostic instrument itself, creating a platform designed to connect molecular testing, clinical workflows and population-level health insights. Our strategy was never just to develop a stand-alone diagnostic instrument. The integrated molecular diagnostic platform was designed to combine hardware, software, connectivity and data into a scalable ecosystem to support decentralized testing while enabling secure reporting, remote system management and real-time data access, which together can help create valuable situational awareness as pockets of infection occur and spread.

Beyond supporting secure connectivity and surveillance, we believe the diagnostic data generated across our connected platform represents a valuable long-term strategic asset. As adoption expands, we are evaluating opportunities to responsibly commercialize these capabilities while supporting healthcare providers, public health agencies and other stakeholders with actionable diagnostic insights. We expect the cloud-based infrastructure that we have developed and begun deploying to be expanded to every regulatory region we have instruments operating, including India and the Kingdom of Saudi Arabia.

Turning to Saudi Arabia. We continued advancing our CoMira joint venture and broader international commercialization strategy. Similar to our strategy in India, CoMira localizes manufacturing and commercialization in key international markets where domestic production can provide meaningful competitive advantages. This quarter, we hosted the executive team from CoMira at our Salt Lake City headquarters to prepare for technology transfer activities. We also unveiled our future automated manufacturing line, which is intended to support increased production capacity as our global footprint expands and which we believe represents an important step towards scaling across multiple international markets.

Our partners in CoMira have previously demonstrated their success in facilitating the distribution of Co-Dx diagnostics across Saudi Arabia, and we look forward to completing the technology transfer and localized manufacturing build-out in Saudi Arabia that we believe will support future expansion into additional markets across the Middle East and North Africa.

Commercial momentum for our Vector Smart business continues to build, expanding our customer footprint across mosquito abatement districts nationwide. Vector Smart shows the versatility of our technology and our ability to address broader public health applications beyond traditional clinical diagnostics while providing real-world validation of our decentralized testing strategy. As mosquito-borne disease threats grow, speed matters. By enabling our abatement district customers across the country to perform molecular testing in-house where decisions are made, abatement districts can reduce turnaround times by performing molecular testing in-house rather than relying on centralized laboratories and demonstrating an approach that we believe can be extended across multiple public health and infectious disease applications.

Overall, the milestones we've discussed today reflect another quarter of meaningful execution across our core strategic priorities. We advanced our regulatory strategy, continued progressing our tuberculosis program, expanded the capabilities of our platform and strengthened the commercial and operational foundation needed to support future growth. While each of these initiatives is important on its own, together, they demonstrate the progress we are making toward commercialization. Just as importantly, they reinforce that our regulatory, commercial, manufacturing and technology investments work together as part of a single short- and long-term strategy. We are pleased that the foundational investments we have made over the past several years are now translating into meaningful operational milestones, positioning the company for the next phase of growth.

With that, I'll now turn the call over to Brian.

Brian Brown

Thanks, Dwight, and thank you to everyone who joined today's call. For the second quarter of 2026, total revenue was $166,000 compared to $163,000 in the same period last year. Cost of revenue for the quarter was $45,000, resulting in a gross profit of approximately $121,000 compared to a gross profit of $131,000 in the prior year period. As we have discussed previously, our current revenue levels remain limited and cost variability can impact gross margin performance at this stage. Total operating expenses for the quarter were $6.3 million compared to $8.2 million in the same period last year. This decrease was primarily driven by lower general and administrative expenses and research and development expenses, including a reduction in legal, personnel and stock-based compensation expenses. As reflected in our reduced operating expenses, we remain committed to disciplined expense management. Research and development expenses were $4.2 million compared to $4.7 million in the prior year period, reflecting lower personnel expenses due to our completed headcount reduction and lower stock-based compensation expense.

Sales and marketing expenses were $467,000 compared to $610,000 in the prior year, and general and administrative expenses were $1.5 million compared to $2.6 million. These decreases were primarily driven by lower stock-based compensation and legal expenses. Net loss for the quarter was $6.3 million, or $1.46 per basic and diluted share, compared to a net loss of $7.7 million, or $7 per basic and diluted share, in the same period last year. The decrease in net loss was primarily driven by lower operating expenses, partially offset by lower other income. Adjusted EBITDA for the quarter was a loss of $5.8 million compared to a loss of $7.2 million in the prior year period.

Turning to the balance sheet. We ended the quarter with $3.6 million in cash and cash equivalents compared to $11.9 million at the end of 2025. The change reflects continued investment in our clinical programs and platform development, partially offset by net proceeds from financing activities during the period. Total assets at quarter end were $16.6 million compared to $24.7 million at year-end. Total liabilities at quarter end were $3.9 million compared to $4.1 million at year-end. We continue to manage our capital resources with discipline, prioritizing investments that support key clinical and regulatory milestones. Although we anticipate continued operating losses in the near term, our priorities remain clear: advancing our clinical pipeline, completing our regulatory submissions and positioning the business for future revenue growth.

To support these objectives, we expect to continue to evaluate available sources of capital, which may include equity or debt financings, strategic transactions and partnerships while staying mindful of dilution and overall capital efficiency. At the same time, we remain focused on pursuing non-dilutive funding such as grants where appropriate. Looking ahead, disciplined capital allocation remains a priority as we approach several important clinical and regulatory milestones and continue preparations for potential commercialization.

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

Dwight Egan

Thank you, Brian. As we close today's call, I want to reiterate that we believe Co-Diagnostics is entering an important new phase in the company's evolution. Over the past several years, we have remained disciplined in building a differentiated molecular diagnostics platform, investing not only in assays and instrumentation, but also in the personnel and the regulatory, manufacturing, digital and commercial capabilities needed to support long-term success.

Today, we are beginning to see those investments translate into tangible operational milestones. The progress we've made across our regulatory, clinical, commercial and technology initiatives reflects years of deliberate investment and reinforces our confidence in the opportunities ahead. As these milestones continue to accumulate, we are also seeing growing engagement from global health organizations, government agencies, commercial partners and other stakeholders. We believe those conversations reflect increasing recognition of both our platform and the opportunities it creates across multiple markets.

While there is still important work ahead, we believe the company is well positioned to execute on the opportunities in front of us and continue advancing toward commercialization across multiple programs. I want to thank our employees for their continued dedication and hard work and our shareholders for their ongoing support and confidence in our long-term vision. We remain encouraged by the momentum we are seeing across the business and look forward to updating you on our continued progress in the quarters ahead.

With that, let's open up the line for questions.

Operator

[Operator Instructions] Your first question comes from Yi Chen with H.C. Wainwright.

分析師問答

Jade Montgomery

This is Jade on for Yi. So I -- just first of all, I just had a little blip in my audio, but did I understand correctly that you plan to submit the tuberculosis for ERPD assessment later this year?

Dwight Egan

That is correct.

Jade Montgomery

Okay. And could you also potentially expand upon the Ebola strategy? I know you said you just completed the proof-of-concept study, but do you have any context for time lines of this development or, like, potentially how useful -- how early the test could be used in infection?

Dwight Egan

Our strategy with Ebola is a strategy that is designed to be ready when if needed. And we've all -- everybody on the planet has been watching the Ebola issue evolve. We were very quick to respond to the development need for an Ebola test. We continue to do that, and we got to the point where we were able to respond to an Indian government-related need for the test through our C-CAMP relationship. They initiated this request for 200 tests, which we have -- are taken care of. And we hope to be ready. In fact, this disease continues to grow and present opportunities for our company, even though it will be a devastating thing for the health of the planet.

Operator

That concludes the Q&A session and our webcast. Thank you for your participation. You may now disconnect, and have a wonderful rest of your day.