Co-Diagnostics, Inc. Reports Third Quarter 2024 Financial Results
Co-Diagnostics (NASDAQ: CODX) reported Q3 2024 financial results with revenue of $0.6 million, down from $2.5 million in the prior year. The company posted a net loss of $9.7 million ($0.32 per share) compared to $6.0 million ($0.20 per share) in 2023. Operating expenses decreased 5% to $10.6 million. The company maintains a strong cash position of $37.7 million. Business highlights include expansion of vector control business to 15 states and preparation for inauguration of oligonucleotide manufacturing facility in India. The company continues FDA dialogue for 510(k) application review and advances its test pipeline development.
Co-Diagnostics (NASDAQ: CODX) ha riportato i risultati finanziari del terzo trimestre 2024, con un fatturato di 0,6 milioni di dollari, in calo rispetto ai 2,5 milioni dell'anno precedente. L'azienda ha registrato una perdita netta di 9,7 milioni di dollari (0,32 dollari per azione), rispetto ai 6,0 milioni di dollari (0,20 dollari per azione) del 2023. Le spese operative sono diminuite del 5% a 10,6 milioni di dollari. L'azienda mantiene una solida posizione di liquidità di 37,7 milioni di dollari. Tra i punti salienti dell'attività, si evidenzia l'espansione nel settore del controllo dei vettori in 15 stati e la preparazione per l'inaugurazione di un impianto di produzione di oligonucleotidi in India. L'azienda prosegue il dialogo con la FDA per la revisione della domanda 510(k) e avanza nello sviluppo della sua pipeline di test.
Co-Diagnostics (NASDAQ: CODX) reportó los resultados financieros del tercer trimestre de 2024, con ingresos de $0.6 millones, en comparación con los $2.5 millones del año anterior. La compañía registró una pérdida neta de $9.7 millones ($0.32 por acción), en comparación con $6.0 millones ($0.20 por acción) en 2023. Los gastos operativos disminuyeron un 5% a $10.6 millones. La empresa mantiene una sólida posición de caja de $37.7 millones. Entre los aspectos destacados del negocio se incluye la expansión del negocio de control de vectores a 15 estados y la preparación para la inauguración de una instalación de fabricación de oligonucleótidos en India. La empresa continúa el diálogo con la FDA para la revisión de la solicitud 510(k) y avanza en el desarrollo de su pipeline de pruebas.
Co-Diagnostics (NASDAQ: CODX)는 2024년 3분기 재무 결과를 보고했으며, 수익은 $0.6백만으로 지난해의 $2.5백만에서 감소했습니다. 회사는 $9.7백만 ($0.32 per share)의 순손실을 기록했으며, 이는 2023년의 $6.0백만 ($0.20 per share)과 비교됩니다. 운영비용은 5% 감소하여 $10.6백만입니다. 회사는 $37.7백만의 강력한 현금 보유를 유지하고 있습니다. 주요 사업 하이라이트에는 15개 주로의 벡터 제어 사업 확장 및 인도에서의 올리고뉴클레오타이드 제조 시설 개소 준비가 포함됩니다. 회사는 510(k) 신청 검토를 위한 FDA와의 대화를 계속 진행하며 테스트 파이프라인 개발을 추진하고 있습니다.
Co-Diagnostics (NASDAQ: CODX) a annoncé les résultats financiers du troisième trimestre 2024, avec des revenus de 0,6 million de dollars, en baisse par rapport à 2,5 millions de dollars l'année précédente. L'entreprise a affiché une perte nette de 9,7 millions de dollars (0,32 dollar par action), contre 6,0 millions de dollars (0,20 dollar par action) en 2023. Les dépenses d'exploitation ont diminué de 5 % pour atteindre 10,6 millions de dollars. L'entreprise maintient une forte position de trésorerie de 37,7 millions de dollars. Parmi les faits marquants de l'entreprise, on note l'expansion de l'activité de contrôle des vecteurs dans 15 États et la préparation à l'inauguration d'une installation de fabrication d'oligonucléotides en Inde. L'entreprise continue le dialogue avec la FDA pour la révision de la demande 510(k) et fait progresser le développement de son pipeline de tests.
Co-Diagnostics (NASDAQ: CODX) hat die Finanzzahlen für das dritte Quartal 2024 veröffentlicht, mit Einnahmen von 0,6 Millionen Dollar, gegenüber 2,5 Millionen Dollar im Vorjahr. Das Unternehmen verzeichnete einen Nettoverlust von 9,7 Millionen Dollar (0,32 Dollar pro Aktie), im Vergleich zu 6,0 Millionen Dollar (0,20 Dollar pro Aktie) im Jahr 2023. Die Betriebskosten sanken um 5 % auf 10,6 Millionen Dollar. Das Unternehmen hält eine starke Liquiditätsposition von 37,7 Millionen Dollar. Zu den Geschäftshighlights gehört die Expansion des Vektorsteuerungsgeschäfts in 15 Bundesstaaten und die Vorbereitung auf die Inauguration einer Oligonukleotid-Produktionsstätte in Indien. Das Unternehmen führt weiterhin einen Dialog mit der FDA bezüglich der Überprüfung des 510(k)-Antrags und verbessert die Entwicklung seiner Testpipeline.
- Strong cash position of $37.7 million
- 5% reduction in operating expenses
- Vector control business expansion to 15 states
- New manufacturing facility opening in India
- Revenue declined 76% to $0.6 million from $2.5 million YoY
- Net loss increased to $9.7 million from $6.0 million YoY
- Loss per share widened to $0.32 from $0.20 YoY
- Operating loss increased to $10.2 million from $8.9 million YoY
Insights
The Q3 2024 results reveal concerning financial trends for Co-Diagnostics.
The regulatory pathway for their PCR platform remains a critical uncertainty, with FDA review ongoing. While the pipeline development shows promise, particularly in tuberculosis and HPV testing, the company needs to accelerate commercialization to address declining revenues and mounting losses. The upcoming oligonucleotide facility in India could help improve margins, but near-term financial pressure persists.
The company's strategic focus on expanding diagnostic capabilities beyond COVID-19 shows promise, particularly with the development of tuberculosis and multiplex respiratory tests. The in silico analysis of their Mpox test demonstrating reactivity against newer strains indicates strong R&D capabilities. The expansion of vector control business across 15 states represents meaningful market penetration.
However, the pending FDA review of the Co-Dx PCR platform remains a important milestone that will determine market access. The company's ability to successfully commercialize its diagnostic pipeline while maintaining regulatory compliance will be essential for future growth. The focus on accessible diagnostics aligns with global healthcare needs, but execution and timeline to market remain critical factors.
Third Quarter 2024 Financial Results:
- Revenue of
$0.6 million $2.5 million $0.4 million $0.2 million - Operating expenses of
$10.6 million 5.0% from the prior year due to higher expenses in 2023 related to platform development and regulatory submission preparation - Operating loss of
$10.2 million $8.9 million - Net loss of
$9.7 million $6.0 million $0.32 $0.20 - Adjusted EBITDA loss of
$8.8 million - Cash, cash equivalents, and marketable securities of
$37.7 million
Third Quarter and Recent 2024 Business Highlights:
- Completed in silico analysis of the Co-Dx™ Logix Smart® Mpox 2-Gene RUO test to evaluate sensitivity for clade 1b mpox, which showed that the test should retain full reactivity against newer strains
- Announced expansion of vector control business line to customers across 15 states
- Attended and participated in ADLM 2024 in
Chicago to discuss the role of the Co-Dx PCR Pro™ Platform* in closing the global diagnostics gap for many indications, including tuberculosis (TB) - Presented and hosted a booth at the 16th Next Generation Dx Summit in
Washington, D.C. , to discuss the future of accessible diagnostics on the Co-Dx PCR Pro Platform* - Oligonucleotide (Co-Primers) manufacturing facility in
India preparing for inauguration in early December 2024
"We are excited by the progress that Co-Diagnostics has made on the development of our pipeline this year," said Dwight Egan, Co-Diagnostics' Chief Executive Officer. "We have maintained an active dialogue with the FDA throughout their substantive review of our 510(k) application, and continue to advance all tests in our pipeline towards completion, regulatory submission and commercialization. At Co-Diagnostics, we firmly believe that our COVID-19, tuberculosis, multiplex respiratory, and HPV multiplex tests on the Co-Dx PCR platform have the potential to increase access to state-of-the-art PCR diagnostics and to improve the quality of health care around the world. Our team has been working hard to make our mission a reality, and I am excited to continue to drive our test developments forward throughout the remainder of the year and into next."
"Co-Diagnostics has made significant progress on our tests, and look forward to providing you with regulatory and commercialization updates as they develop," 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
Conference Call: 844-481-2661 (domestic) or 412-317-0652 (international)
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. The Co-Dx PCR Pro instrument and Co-Dx COVID-19 Test are currently under review by the FDA.
About Co-Diagnostics, Inc.:
Co-Diagnostics, Inc., a
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, realized gains on investments, stock-based compensation, change in fair value of contingent consideration, gain or loss on disposition of assets, and one-time transaction related costs. 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 our advancement of all tests in our pipeline towards completion, regulatory submission and commercialization and our belief that our COVID-19, tuberculosis, multiplex respiratory, and HPV multiplex tests on the Co-Dx PCR platform have the potential to increase access to state-of-the-art PCR diagnostics and to improve the quality of health care around the world. 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 14, 2024, 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.
CO-DIAGNOSTICS, INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS (Unaudited) | ||||||||
September 30, 2024 | December 31, 2023 | |||||||
Assets | ||||||||
Current assets | ||||||||
Cash and cash equivalents | $ | 10,797,630 | $ | 14,916,878 | ||||
Marketable investment securities | 26,864,571 | 43,631,510 | ||||||
Accounts receivable, net | 178,243 | 303,926 | ||||||
Inventory, net | 1,266,016 | 1,664,725 | ||||||
Income taxes receivable | - | 26,955 | ||||||
Prepaid expenses and other current assets | 996,698 | 1,597,114 | ||||||
Total current assets | 40,103,158 | 62,141,108 | ||||||
Property and equipment, net | 2,984,112 | 3,035,729 | ||||||
Operating lease right-of-use asset | 2,332,877 | 2,966,774 | ||||||
Intangible assets, net | 26,176,667 | 26,403,667 | ||||||
Investment in joint venture | 784,357 | 773,382 | ||||||
Total assets | $ | 72,381,171 | $ | 95,320,660 | ||||
Liabilities and stockholders' equity | ||||||||
Current liabilities | ||||||||
Accounts payable | $ | 2,176,426 | $ | 1,482,109 | ||||
Accrued expenses | 1,826,297 | 2,172,959 | ||||||
Operating lease liability, current | 896,745 | 838,387 | ||||||
Contingent consideration liabilities, current | 838,032 | 891,666 | ||||||
Deferred revenue | 60,477 | 362,449 | ||||||
Total current liabilities | 5,797,977 | 5,747,570 | ||||||
Long-term liabilities | ||||||||
Income taxes payable | 719,628 | 659,186 | ||||||
Operating lease liability | 1,472,100 | 2,152,180 | ||||||
Contingent consideration liabilities | 607,526 | 748,109 | ||||||
Total long-term liabilities | 2,799,254 | 3,559,475 | ||||||
Total liabilities | 8,597,231 | 9,307,045 | ||||||
Commitments and contingencies (Note 10) | ||||||||
Stockholders' equity | ||||||||
Convertible preferred stock, | - | - | ||||||
Common stock, | 36,778 | 36,108 | ||||||
Treasury stock, at cost; 4,848,678 shares held as of September 30, | (15,575,795) | (15,575,795) | ||||||
Additional paid-in capital | 100,924,241 | 96,808,436 | ||||||
Accumulated other comprehensive income | 408,366 | 146,700 | ||||||
Accumulated earnings (deficit) | (22,009,650) | 4,598,166 | ||||||
Total stockholders' equity | 63,783,940 | 86,013,615 | ||||||
Total liabilities and stockholders' equity | $ | 72,381,171 | $ | 95,320,660 | ||||
CO-DIAGNOSTICS, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) | ||||||||
Three Months Ended September 30, | ||||||||
2024 | 2023 | |||||||
Product revenue | $ | 206,876 | $ | 136,533 | ||||
Grant revenue | 434,265 | 2,320,565 | ||||||
Total revenue | 641,141 | 2,457,098 | ||||||
Cost of revenue | 297,403 | 255,772 | ||||||
Gross profit | 343,738 | 2,201,326 | ||||||
Operating expenses | ||||||||
Sales and marketing | 1,059,745 | 1,904,395 | ||||||
General and administrative | 4,287,380 | 3,147,753 | ||||||
Research and development | 4,880,315 | 5,788,789 | ||||||
Depreciation and amortization | 351,235 | 296,340 | ||||||
Total operating expenses | 10,578,675 | 11,137,277 | ||||||
Loss from operations | (10,234,937) | (8,935,951) | ||||||
Other income, net | ||||||||
Interest income | 263,335 | 322,877 | ||||||
Realized gain on investments | 293,067 | 425,446 | ||||||
Gain on disposition of assets | 3,513 | (2,578) | ||||||
Gain (loss) on remeasurement of acquisition contingencies | (11,927) | 140,296 | ||||||
Gain (loss) on equity method investment in joint venture | 12,683 | (45,865) | ||||||
Total other income, net | 560,671 | 840,176 | ||||||
Loss before income taxes | (9,674,266) | (8,095,775) | ||||||
Income tax provision (benefit) | 22,189 | (2,113,581) | ||||||
Net loss | $ | (9,696,455) | $ | (5,982,194) | ||||
Other comprehensive loss | ||||||||
Change in net unrealized gains on marketable securities, net of tax | 37,158 | 33,522 | ||||||
Total other comprehensive income | $ | 37,158 | $ | 33,522 | ||||
Comprehensive loss | $ | (9,659,297) | $ | (5,948,672) | ||||
Loss per common share: | ||||||||
Basic and Diluted | $ | (0.32) | $ | (0.20) | ||||
Weighted average shares outstanding: | ||||||||
Basic and Diluted | 30,494,206 | 29,361,300 | ||||||
CO-DIAGNOSTICS, INC. AND SUBSIDIARIES GAAP AND NON-GAAP MEASURES (Unaudited) | ||||||||
Reconciliation of net loss to adjusted EBITDA: | ||||||||
Three Months Ended September 30, | ||||||||
2024 | 2023 | |||||||
Net loss | $ | (9,696,455) | $ | (5,982,194) | ||||
Interest income | (263,335) | (322,877) | ||||||
Realized gain on investments | (293,067) | (425,446) | ||||||
Depreciation and amortization | 351,235 | 296,340 | ||||||
Gain on disposition of assets | (3,513) | 2,578 | ||||||
Stock-based compensation expense | 1,045,583 | 2,172,165 | ||||||
Income tax provision (benefit) | 22,189 | (2,113,581) | ||||||
Change in fair value of contingent consideration | 11,927 | (140,296) | ||||||
Adjusted EBITDA | $ | (8,825,436) | $ | (6,513,311) | ||||
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SOURCE Co-Diagnostics
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