Item 1.05 section not located in normalized markdown

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): April 10, 2024

(Exact Name of Registrant as Specified in Charter)

| Delaware | 001-16537 | 36-4370966 | ||
| (State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |

| 220 East First Street Bethlehem, Pennsylvania |
18015-1360 | |
| (Address of Principal Executive Offices) | (Zip Code) |

Registrant’s telephone number, including area code: 610-882-1820

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the Registrant under any of the following provisions:

| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |

| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |

| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |

| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |

Securities registered pursuant to Section 12(b) of the Act:

| Title of each class |
Trading |
Name of each exchange on which registered | ||
| Common Stock, $0.000001 par value per share | OSUR | The NASDAQ Stock Market LLC |

Indicate by a check mark whether the Registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the Registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

| Item 1.05 | Material Cybersecurity Incidents. |

On or about March 27, 2024, OraSure Technologies, Inc. (the “Company”) became aware of a cybersecurity incident in which an unauthorized third party gained access to Company data from certain information systems. Following detection of the incident, the Company initiated response protocols, commenced an investigation with the assistance of cybersecurity experts and external counsel, and notified law enforcement. The Company believes it has contained the incident and believes it has preserved the integrity of its core financial and operational systems.

Although the Company ascertained that certain files were exfiltrated, it is still investigating the extent of any sensitive information contained within the accessed systems, including any personal information. It is evaluating what, if any, regulatory and legal notifications are required as a result of this incident and will make such notifications as required based on its findings.

As of the date hereof, the incident has not had a material impact on the Company’s operations, financial systems, or its financial condition. The Company’s information systems are operational, and it does not anticipate that this incident will have a material impact on its financial condition and results of operations moving forward. While the Company believes it has contained the incident, it continues to investigate this matter to determine the full extent of the impact on the Company.

| Item 7.01 | Regulation FD Disclosure. |

The Company reiterates its previously communicated financial guidance regarding its revenue for the first quarter of 2024.

The information in this Item shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section, nor shall such information and Exhibit be deemed incorporated by reference in any filing under the Securities Act of 1933, except as shall be expressly set forth by specific referen