Co-Diagnostics, Inc. Reports First Quarter 2025 Financial Results
L'azienda rimane in linea per avviare le valutazioni cliniche di 4 test nel suo portafoglio prodotti e completare la struttura produttiva in India entro la fine del 2025. Questi test includono tubercolosi, multiplex respiratorio, multiplex HPV e COVID-19, tutti progettati per essere utilizzati con la piattaforma Co-Dx PCR Pro, attualmente in attesa di revisione da parte della FDA.
La empresa sigue en camino para iniciar evaluaciones clínicas de 4 pruebas en su cartera de productos y completar su planta de fabricación en India para finales de 2025. Estas pruebas incluyen tuberculosis, multiplex respiratorio, multiplex de VPH y COVID-19, todas diseñadas para usarse con la plataforma Co-Dx PCR Pro, que aún está pendiente de revisión por la FDA.
회사는 4가지 테스트에 대한 임상 평가를 시작하고 2025년 말까지 인도 제조 시설을 완공할 계획을 차질 없이 진행 중입니다. 이 테스트들은 결핵, 호흡기 다중검사, HPV 다중검사, COVID-19를 포함하며 모두 FDA 검토가 아직 진행 중인 Co-Dx PCR Pro 플랫폼과 함께 사용하도록 설계되었습니다.
L'entreprise reste en bonne voie pour lancer les évaluations cliniques de 4 tests dans son pipeline de produits et achever son usine de fabrication en Inde d'ici la fin de l'année 2025. Ces tests incluent la tuberculose, le multiplex respiratoire, le multiplex HPV et le COVID-19, tous conçus pour être utilisés avec la plateforme Co-Dx PCR Pro, qui est toujours en attente d'examen par la FDA.
Das Unternehmen bleibt auf Kurs, um klinische Bewertungen von 4 Tests in seiner Produktpipeline zu starten und die Fertigungsanlage in Indien bis Ende 2025 abzuschließen. Diese Tests umfassen Tuberkulose, respiratorisches Multiplex, HPV-Multiplex und COVID-19, die alle für die Nutzung mit der Co-Dx PCR Pro Plattform entwickelt wurden, die sich noch in der FDA-Prüfung befindet.
- Operating expenses decreased 18.2% year-over-year
- Net loss improved to $7.5 million from $9.3 million in Q1 2024
- Strong cash position of $21.5 million
- On track for clinical evaluations of 4 tests and India facility completion by year-end
- Revenue declined 80% to $0.1 million from $0.5 million in Q1 2024
- Operating loss of $8.6 million
- Adjusted EBITDA loss of $7.4 million
- Core product (Co-Dx PCR platform) still pending FDA approval
Insights
Co-Diagnostics reports minimal Q1 revenue ($0.1M), reduced losses, but faces significant cash constraints while advancing pre-commercial diagnostic platform.
Co-Diagnostics's Q1 2025 results paint a picture of a company in development phase with significant financial challenges. Revenue plummeted to just
The financial position shows
On the development front, Co-Diagnostics remains focused on their Co-Dx PCR platform with four key tests in their pipeline (tuberculosis, respiratory multiplex, HPV multiplex, and COVID-19). The company reports being on track for clinical evaluations of these tests and completion of their India manufacturing facility by year-end 2025.
Critically, the Co-Dx PCR platform (including all associated tests) remains subject to FDA and regulatory review and is not yet commercially available. With limited current revenue sources and continued substantial cash burn, the company's financial outlook hinges on successful regulatory advancement and eventual commercialization of their diagnostic platform.
SALT LAKE CITY, May 08, 2025 (GLOBE NEWSWIRE) -- Co-Diagnostics, Inc. (NASDAQ: CODX), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced financial results for the quarter ended March 31, 2025.
First Quarter 2025 Financial Results:
| ● | Revenue of | |
| ● | Operating expenses of | |
| ● | Operating loss of | |
| ● | Net loss of | |
| ● | Adjusted EBITDA loss of | |
| ● | Cash, cash equivalents, and marketable securities of | |
First Quarter Business Highlights:
| ● | Remain on track for initiation of clinical evaluations for 4 tests in product pipeline and completion of manufacturing facility in India by year-end 2025 | |
| ● | Hosted a symposium to honor International HPV Awareness Day 2025 in India, in collaboration with CoSara, as the Company prepares for pre-clinical and pre-analytical studies for its HPV test to be utilized on the Co-Dx™ PCR Pro™ instrument* | |
| ● | Hosted a booth at BioUtah’s Life Sciences Day on the Hill at the Utah State Capitol Rotunda, which showcased Co-Dx’s upcoming at-home and point-of-care Co-Dx PCR platform* | |
“During the quarter, Co-Diagnostics continued to make significant progress in the development of our test pipeline,” said Dwight Egan, Co-Diagnostics’ Chief Executive Officer. “Our priority remains bringing the Co-Dx PCR platform to market, as we advance towards clinical evaluations and regulatory submissions for the 4 main tests in our pipeline. We believe our tuberculosis, respiratory multiplex, HPV multiplex, and COVID-19 tests, to be utilized on the Co-Dx PCR Pro, will play a key role in transforming the global accessibility of diagnostic testing solutions. I am proud of the progress our team has made and look forward to building upon our momentum throughout the rest of the year.”
“Our team made strong progress on our development pipeline during the quarter. Co-Diagnostics remains focused on maintaining operational efficiency as we advance towards several development milestones, including the commencement of clinical evaluations. We look forward to providing you with updates as they come,” said Brian Brown, Co-Diagnostics’ Chief Financial Officer.
Conference Call and Webcast
Co-Diagnostics will host a conference call and webcast at 4:30 p.m. EDT today to discuss its financial results with analysts and institutional investors. The conference call and webcast will be available via:
Webcast: ir.codiagnostics.com on the Events & Webcasts page, or accessible directly here
Conference Call: 800-715-9871 (Toll Free) or (646) 307-1963 (Toll) with participant passcode 1977478
The call will be recorded and later made available on the Company’s website: https://codiagnostics.com.
*The Co-Dx PCR platform (including the PCR Home™, PCR Pro™, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale.
About Co-Diagnostics, Inc.
Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets state-of-the-art diagnostics technologies. The Company’s technologies are utilized for tests that are designed using the detection and/or analysis of nucleic acid molecules (DNA or RNA). The Company also uses its proprietary technology to design specific tests for its Co-Dx PCR at-home and point-of-care platform and to identify genetic markers for use in applications other than infectious disease.
Non-GAAP Financial Measures:
This press release contains adjusted EBITDA, which is a non-GAAP measure defined as net income excluding depreciation, amortization, income tax (benefit) expense, net interest (income) expense, stock-based compensation, change in fair value of contingent consideration, and realized gain (loss) on investments. The Company believes that adjusted EBITDA provides useful information to management and investors relating to its results of operations. The Company’s management uses this non-GAAP measure to compare the Company’s performance to that of prior periods for trend analyses, and for budgeting and planning purposes. The Company believes that the use of adjusted EBITDA provides an additional tool for investors to use in evaluating ongoing operating results and trends and in comparing the Company’s financial measures with other companies, many of which present similar non-GAAP financial measures to investors, and that it allows for greater transparency with respect to key metrics used by management in its financial and operational decision-making.
Management does not consider the non-GAAP measure in isolation or as an alternative to financial measures determined in accordance with GAAP. The principal limitation of the non-GAAP financial measure is that it excludes significant expenses that are required by GAAP to be recorded in the Company’s financial statements. In order to compensate for these limitations, management presents the non-GAAP financial measure together with GAAP results. Non-GAAP measures should be considered in addition to results prepared in accordance with GAAP, but should not be considered a substitute for, or superior to, GAAP results. A reconciliation table of the net income, the most comparable GAAP financial measure to adjusted EBITDA, is included at the end of this release. The Company urges investors to review the reconciliation and not to rely on any single financial measure to evaluate the company’s business.
Forward-Looking Statements:
This press release contains forward-looking statements. Forward-looking statements can be identified by words such as “believes,” “expects,” “estimates,” “intends,” “may,” “plans,” “will” and similar expressions, or the negative of these words. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. Forward-looking statements in this release include statements regarding (i) advancement into clinical evaluations and continued development and regulatory submissions for the Co-Dx PCR platform and (ii) our belief that the platform will play a key role in transforming the global accessibility of diagnostic testing solutions. Forward-looking statements are subject to inherent uncertainties, risks and changes in circumstances. Actual results may differ materially from those contemplated or anticipated by such forward-looking statements. Readers of this press release are cautioned not to place undue reliance on any forward-looking statements. There can be no assurance that any of the anticipated results will occur on a timely basis or at all due to certain risks and uncertainties, a discussion of which can be found in our Risk Factors disclosure in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 27, 2025, and in our other filings with the SEC. The Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.
Investor Relations Contact:
Andrew Benson
Head of Investor Relations
+1 801-438-1036
investors@codiagnostics.com
| CO-DIAGNOSTICS, INC. AND SUBSIDIARIES | ||||||||
| CONSOLIDATED BALANCE SHEETS | ||||||||
| (Unaudited) | ||||||||
| March 31, 2025 | December 31, 2024 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 1,903,034 | $ | 2,936,544 | ||||
| Marketable investment securities | 19,575,902 | 26,811,098 | ||||||
| Accounts receivable, net | 136,391 | 132,570 | ||||||
| Inventory, net | 1,083,309 | 1,072,724 | ||||||
| Income taxes receivable | 574 | - | ||||||
| Prepaid expenses and other current assets | 1,132,281 | 1,338,762 | ||||||
| Total current assets | 23,831,491 | 32,291,698 | ||||||
| Property and equipment, net | 2,593,808 | 2,761,280 | ||||||
| Operating lease right-of-use asset | 1,893,422 | 2,114,876 | ||||||
| Intangible assets, net | 26,101,000 | 26,101,000 | ||||||
| Investment in joint venture | 729,621 | 731,065 | ||||||
| Total assets | $ | 55,149,342 | $ | 63,999,919 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 2,712,642 | $ | 3,294,254 | ||||
| Accrued expenses | 1,610,890 | 2,562,169 | ||||||
| Operating lease liability, current | 902,881 | 915,619 | ||||||
| Contingent consideration liabilities, current | 109,275 | 502,819 | ||||||
| Deferred revenue | 40,857 | 40,857 | ||||||
| Total current liabilities | 5,376,545 | 7,315,718 | ||||||
| Long-term liabilities | ||||||||
| Income taxes payable | 725,127 | 713,643 | ||||||
| Operating lease liability | 1,028,282 | 1,236,560 | ||||||
| Contingent consideration liabilities | 98,557 | 422,080 | ||||||
| Total long-term liabilities | 1,851,966 | 2,372,283 | ||||||
| Total liabilities | 7,228,511 | 9,688,001 | ||||||
| Commitments and contingencies (Note 10) | ||||||||
| Stockholders’ equity | ||||||||
| Convertible preferred stock, | - | - | ||||||
| Common stock, | 38,421 | 37,902 | ||||||
| Treasury stock, at cost; 4,848,678 shares held as of March 31, 2025 and December 31, 2024, respectively | (15,575,795 | ) | (15,575,795 | ) | ||||
| Additional paid-in capital | 103,701,665 | 102,472,210 | ||||||
| Accumulated other comprehensive income | 330,653 | 418,443 | ||||||
| Accumulated earnings (deficit) | (40,574,113 | ) | (33,040,842 | ) | ||||
| Total stockholders’ equity | 47,920,831 | 54,311,918 | ||||||
| Total liabilities and stockholders’ equity | $ | 55,149,342 | $ | 63,999,919 | ||||
| CO-DIAGNOSTICS, INC. AND SUBSIDIARIES | ||||||||
| CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||
| (Unaudited) | ||||||||
| Three Months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| Product revenue | $ | 50,277 | $ | 252,745 | ||||
| Grant revenue | - | 215,109 | ||||||
| Total revenue | 50,277 | 467,854 | ||||||
| Cost of revenue | 21,590 | 234,505 | ||||||
| Gross profit | 28,687 | 233,349 | ||||||
| Operating expenses | ||||||||
| Sales and marketing | 657,030 | 1,563,682 | ||||||
| General and administrative | 2,773,149 | 2,918,803 | ||||||
| Research and development | 4,870,019 | 5,679,678 | ||||||
| Depreciation and amortization | 280,445 | 330,573 | ||||||
| Total operating expenses | 8,580,643 | 10,492,736 | ||||||
| Loss from operations | (8,551,956 | ) | (10,259,387 | ) | ||||
| Other income, net | ||||||||
| Interest income, net | 13,601 | 362,733 | ||||||
| Realized gain on investments | 301,465 | 228,070 | ||||||
| Gain on remeasurement of acquisition contingencies | 717,067 | 450,260 | ||||||
| Loss on equity method investment in joint venture | (1,444 | ) | (70,955 | ) | ||||
| Total other income, net | 1,030,689 | 970,108 | ||||||
| Loss before income taxes | (7,521,267 | ) | (9,289,279 | ) | ||||
| Income tax provision | 12,004 | 22,764 | ||||||
| Net loss | $ | (7,533,271 | ) | $ | (9,312,043 | ) | ||
| Other comprehensive income (loss) | ||||||||
| Change in net unrealized gains on marketable securities, net of tax | (87,790 | ) | 79,855 | |||||
| Total other comprehensive income (loss) | $ | (87,790 | ) | $ | 79,855 | |||
| Comprehensive loss | $ | (7,621,061 | ) | $ | (9,232,188 | ) | ||
| Loss per common share: | ||||||||
| Basic and Diluted | $ | (0.24 | ) | $ | (0.31 | ) | ||
| Weighted average shares outstanding: | ||||||||
| Basic and Diluted | 32,048,953 | 29,842,874 | ||||||
| CO-DIAGNOSTICS, INC. AND SUBSIDIARIES | ||||||||
| GAAP AND NON-GAAP MEASURES | ||||||||
| (Unaudited) | ||||||||
| Reconciliation of net loss to adjusted EBITDA: | ||||||||
| Three Months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| Net loss | $ | (7,533,271 | ) | $ | (9,312,043 | ) | ||
| Interest income, net | (13,601 | ) | (362,733 | ) | ||||
| Realized gain on investments | (301,465 | ) | (228,070 | ) | ||||
| Depreciation and amortization | 280,445 | 330,573 | ||||||
| Change in fair value of contingent consideration | (717,067 | ) | (450,260 | ) | ||||
| Stock-based compensation expense | 875,228 | 1,571,234 | ||||||
| Income tax provision | 12,004 | 22,764 | ||||||
| Adjusted EBITDA | $ | (7,397,727 | ) | $ | (8,428,535 | ) | ||
FAQ
What were CODX's Q1 2025 revenue and earnings?
How much cash does Co-Diagnostics (CODX) have as of Q1 2025?
What are the 4 tests in CODX's development pipeline?
When will Co-Diagnostics complete its manufacturing facility in India?
Has the Co-Dx PCR platform received FDA approval?
