코다이애그노스틱스(CODX) 2026년 2분기 실적 발표 콘퍼런스 콜: 현금 감소 속 FDA 신청 진척

핵심 요약

• 2026년 2분기 매출은 16만 6,000달러로 전년 동기의 16만 3,000달러 대비 증가했습니다. 매출총이익은 13만 1,000달러에서 약 12만 1,000달러로 감소했습니다.
• 일반관리비, 연구개발비, 법률 비용, 인건비 및 주식 기반 보상 비용 감소에 힘입어 영업비용은 820만 달러에서 630만 달러로 줄었습니다.
• 순손실은 770만 달러(주당 7.00달러)에서 630만 달러(기본 및 희석 주당 1.46달러)로 축소되었습니다. 조정 EBITDA 손실은 720만 달러에서 580만 달러로 개선되었습니다.
• 코디애그노스틱스는 Co-Dx PCR 플랫폼 기반의 인플루엔자 A, 인플루엔자 B 및 RSV 진단 시약에 대해 미국 식품의약국(FDA)에 510(k) 및 CLIA 면제 이중 신청서를 제출했습니다.
• 현금 및 현금성 자산은 2025년 말 1,190만 달러에서 360만 달러로 감소했습니다. 경영진은 단기적으로 영업손실이 지속될 것으로 예상하며 지분, 부채, 전략적 거래, 파트너십 및 비희석성 자금 조달 방안을 검토할 계획입니다.
• 회사는 결핵 프로그램과 관련해 2026년 말 인도 중앙의약품표준통제국(CDSCO) 및 자격 요건과 시기에 따라 세계보건기구(WHO) 진단 전문가 검토 패널(ERPD)에 신청서를 제출하는 것을 목표로 하고 있습니다.

주요 재무 데이터

사업 및 영업 실적

상호흡기 프로그램이 주요 규제 이정표에 도달했습니다. 코디애그노스틱스는 Co-Dx PCR 플랫폼 기반의 인플루엔자 A, 인플루엔자 B 및 RSV 진단 시약에 대한 FDA 제출을 뒷받침하는 분석 및 임상 성능 연구를 완료했습니다.

분석 프로그램은 PCR Pro 장비에서 진행된 27개 연구와 1만 회 이상의 PCR 검사로 구성되었습니다. 임상 연구는 미국 내 9개 기관에서 유증상 환자 1,400명 이상을 대상으로 진행되었습니다. 이후 회사는 FDA에 510(k) 및 CLIA 면제 이중 신청서를 제출했습니다. 해당 플랫폼 및 관련 검사는 여전히 규제 당국의 심사 대상이며 현재 판매되지 않고 있습니다.

인도에서는 CoSara PCR Pro 장비 및 CoSara PCR MTB 검사에 대한 임상 연구가 진행 중입니다. 코디애그노스틱스는 합작법인인 CoSara가 현지 생산, 규제 전문성, 상업화 인프라를 제공하고 있다고 밝혔습니다. ERPD 평가에 필요한 일부 검증 비용은 비정부기구(NGO) 파트너들로부터 주로 지원받고 있습니다.

회사는 또한 Co-Dx PCR Pro 장비용 최초의 혈액 기반 진단 시약인 혈장 검체를 활용한 에볼라 검사의 개념 검증 연구를 완료했습니다. CoSara는 중앙 검사소를 위한 분디부교 바이러스 및 범에볼라(pan-Ebola) 검사를 개발 중이며, 제3자 평가를 위한 분디부교 검사 200건 요청에 대응했습니다.

사우디아라비아에서는 합작법인 CoMira가 기술 이전 및 현지 생산을 위한 준비를 이어갔습니다. 경영진은 이러한 인프라가 향후 중동 및 북아프리카 전역으로의 확장을 뒷받침할 수 있다고 설명했습니다.

코디애그노스틱스는 미국 모기 퇴치 구역 내 고객 기반이 확대됨에 따라 Vector Smart의 지속적인 상업적 성장 모멘텀도 보고했습니다. 해당 사업을 통해 고객은 중앙 검사소에 의존하는 대신 자체적으로 분자 진단을 수행할 수 있습니다.

경영진 전망

경영진은 회사가 임상 프로그램, 규제당국 제출 및 상업화 준비를 추진하는 동안 단기적으로 영업손실이 지속될 것으로 예상합니다.

결핵 프로그램의 경우, 코디애그노스틱스는 2026년 말 인도 CDSCO 제출 및 해당 자격 요건과 시기에 따라 WHO ERPD 제출을 목표로 하고 있습니다.

회사는 규율 있는 자본 배분을 유지하며 지분 또는 부채 조달, 전략적 거래, 파트너십 및 보조금을 검토할 계획입니다. 정량적인 매출이나 수익성 전망은 제공되지 않았습니다.

위험 요인 및 주시 사항

• 분기 말 현금 및 현금성 자산은 360만 달러로, 2025년 말의 1,190만 달러에서 감소했습니다.
• 추가 자금 조달에는 주식 발행을 통한 자금 조달이 포함될 수 있어 잠재적 지분 희석이 발생할 수 있으나, 경영진은 희석과 자본 효율성을 주시하고 있다고 밝혔습니다.
• 현재 매출은 제한적인 수준이며, 경영진은 현 단계에서 비용 변동성이 매출총이익률에 중대한 영향을 미칠 수 있다고 지적했습니다.
• Co-Dx PCR 플랫폼 및 관련 진단 시약은 상업적 판매 전에 규제당국의 허가 또는 승인이 필요합니다.
• FDA, CDSCO 및 ERPD 심사 시기와 결과는 여전히 불확실하며 규제 요건의 적용을 받습니다.

애널리스트 Q&A 주요 내용

경영진은 코디애그노스틱스가 자격 요건 및 시기 조건에 따라 2026년 말 결핵 검사에 대한 ERPD 평가를 신청할 계획임을 확인했습니다.

에볼라와 관련해 드와이트 이건(Dwight Egan) CEO는 검사 수요가 발생할 경우 대응할 수 있도록 준비하는 전략이라고 설명했습니다. 회사는 개념 검증 작업을 완료하고 인도 관련 요청에 따라 200건의 검사를 공급했으나, 구체적인 개발 또는 상업화 일정은 제공하지 않았습니다.

실적발표 컨퍼런스 콜 전문

전체 실적 발표 컨퍼런스 콜 녹취록

경영진 발표

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.

질의응답

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.