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ORASURE TECHNOLOGIES INC
Response Received
1 company response(s)
High - file number match
↓
ORASURE TECHNOLOGIES INC
Awaiting Response
0 company response(s)
High
SEC wrote to company
2024-12-04
ORASURE TECHNOLOGIES INC
Summary
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ORASURE TECHNOLOGIES INC
Response Received
6 company response(s)
High - file number match
SEC wrote to company
2009-09-01
ORASURE TECHNOLOGIES INC
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Company responded
2009-09-29
ORASURE TECHNOLOGIES INC
References: August 31, 2009
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2015-10-29
ORASURE TECHNOLOGIES INC
References: September 30, 2015
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2024-04-10
ORASURE TECHNOLOGIES INC
References: March 20, 2024
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2024-05-01
ORASURE TECHNOLOGIES INC
References: April 26, 2024
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2024-06-10
ORASURE TECHNOLOGIES INC
References: May 24, 2024
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2024-10-31
ORASURE TECHNOLOGIES INC
References: October 17, 2024
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ORASURE TECHNOLOGIES INC
Awaiting Response
0 company response(s)
High
SEC wrote to company
2024-10-17
ORASURE TECHNOLOGIES INC
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ORASURE TECHNOLOGIES INC
Awaiting Response
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SEC wrote to company
2024-05-24
ORASURE TECHNOLOGIES INC
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ORASURE TECHNOLOGIES INC
Awaiting Response
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SEC wrote to company
2024-05-02
ORASURE TECHNOLOGIES INC
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ORASURE TECHNOLOGIES INC
Awaiting Response
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2024-04-26
ORASURE TECHNOLOGIES INC
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ORASURE TECHNOLOGIES INC
Awaiting Response
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SEC wrote to company
2024-03-20
ORASURE TECHNOLOGIES INC
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ORASURE TECHNOLOGIES INC
Response Received
3 company response(s)
High - file number match
SEC wrote to company
2022-02-17
ORASURE TECHNOLOGIES INC
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2022-05-13
ORASURE TECHNOLOGIES INC
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2022-05-18
ORASURE TECHNOLOGIES INC
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2022-05-18
ORASURE TECHNOLOGIES INC
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ORASURE TECHNOLOGIES INC
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2019-02-05
ORASURE TECHNOLOGIES INC
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2019-02-11
ORASURE TECHNOLOGIES INC
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ORASURE TECHNOLOGIES INC
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2015-12-15
ORASURE TECHNOLOGIES INC
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2015-12-16
ORASURE TECHNOLOGIES INC
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ORASURE TECHNOLOGIES INC
Awaiting Response
0 company response(s)
High
SEC wrote to company
2015-11-09
ORASURE TECHNOLOGIES INC
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ORASURE TECHNOLOGIES INC
Awaiting Response
0 company response(s)
High
SEC wrote to company
2015-09-30
ORASURE TECHNOLOGIES INC
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ORASURE TECHNOLOGIES INC
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2012-10-18
ORASURE TECHNOLOGIES INC
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2012-12-19
ORASURE TECHNOLOGIES INC
References: December 11, 2012 | December 17, 2012
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Company responded
2012-12-20
ORASURE TECHNOLOGIES INC
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ORASURE TECHNOLOGIES INC
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-12-11
ORASURE TECHNOLOGIES INC
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ORASURE TECHNOLOGIES INC
Awaiting Response
0 company response(s)
High
SEC wrote to company
2009-10-26
ORASURE TECHNOLOGIES INC
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ORASURE TECHNOLOGIES INC
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2006-09-07
ORASURE TECHNOLOGIES INC
Summary
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ORASURE TECHNOLOGIES INC
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2005-05-19
ORASURE TECHNOLOGIES INC
References: April 22, 2005
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2005-06-10
ORASURE TECHNOLOGIES INC
References: April 22, 2005 | May 18, 2005
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ORASURE TECHNOLOGIES INC
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2005-04-08
ORASURE TECHNOLOGIES INC
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Company responded
2005-04-22
ORASURE TECHNOLOGIES INC
References: April 8, 2005
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-27 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | 333-287446 | Read Filing View |
| 2025-05-27 | Company Response | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2024-12-04 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | 001-16537 | Read Filing View |
| 2024-10-31 | Company Response | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2024-10-17 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | 001-16537 | Read Filing View |
| 2024-06-10 | Company Response | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2024-05-24 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | 001-16537 | Read Filing View |
| 2024-05-02 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | 001-16537 | Read Filing View |
| 2024-05-01 | Company Response | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2024-04-26 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | 001-16537 | Read Filing View |
| 2024-04-10 | Company Response | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2024-03-20 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | 001-16537 | Read Filing View |
| 2022-05-18 | Company Response | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2022-05-18 | Company Response | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2022-05-13 | Company Response | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2022-02-17 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2019-02-11 | Company Response | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2019-02-05 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2015-12-16 | Company Response | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2015-12-15 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2015-11-09 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2015-10-29 | Company Response | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2015-09-30 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2012-12-20 | Company Response | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2012-12-19 | Company Response | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2012-12-11 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2012-10-18 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2009-10-26 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2009-09-29 | Company Response | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2009-09-01 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2006-09-07 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2005-06-10 | Company Response | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2005-05-19 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2005-04-22 | Company Response | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2005-04-08 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-27 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | 333-287446 | Read Filing View |
| 2024-12-04 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | 001-16537 | Read Filing View |
| 2024-10-17 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | 001-16537 | Read Filing View |
| 2024-05-24 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | 001-16537 | Read Filing View |
| 2024-05-02 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | 001-16537 | Read Filing View |
| 2024-04-26 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | 001-16537 | Read Filing View |
| 2024-03-20 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | 001-16537 | Read Filing View |
| 2022-02-17 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2019-02-05 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2015-12-15 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2015-11-09 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2015-09-30 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2012-12-11 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2012-10-18 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2009-10-26 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2009-09-01 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2006-09-07 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2005-05-19 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2005-04-08 | SEC Comment Letter | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-27 | Company Response | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2024-10-31 | Company Response | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2024-06-10 | Company Response | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2024-05-01 | Company Response | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2024-04-10 | Company Response | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2022-05-18 | Company Response | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2022-05-18 | Company Response | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2022-05-13 | Company Response | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2019-02-11 | Company Response | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2015-12-16 | Company Response | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2015-10-29 | Company Response | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2012-12-20 | Company Response | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2012-12-19 | Company Response | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2009-09-29 | Company Response | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2005-06-10 | Company Response | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
| 2005-04-22 | Company Response | ORASURE TECHNOLOGIES INC | DE | N/A | Read Filing View |
2025-05-27 - UPLOAD - ORASURE TECHNOLOGIES INC File: 333-287446
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> May 27, 2025 Carrie Eglinton Manner President and Chief Executive Officer OraSure Technologies, Inc. 220 East First Street Bethlehem, PA 18015 Re: OraSure Technologies, Inc. Registration Statement on Form S-3 Filed May 20, 2025 File No. 333-287446 Dear Carrie Eglinton Manner: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Nicholas O'Leary at 202-551-4451 with any questions. Sincerely, Division of Corporation Finance Office of Industrial Applications and Services cc: Justin Platt, Esq. </TEXT> </DOCUMENT>
2025-05-27 - CORRESP - ORASURE TECHNOLOGIES INC
CORRESP 1 filename1.htm CORRESP OraSure Technologies, Inc. 220 East First Street Bethlehem, PA 18015 May 27, 2025 Via EDGAR Transmission Securities and Exchange Commission Division of Corporation Finance Office of Industrial Applications and Services 100 F Street, N.E. Washington, D.C. 20549 Attention: Nicholas O’Leary Re: OraSure Technologies, Inc. Registration Statement on Form S-3 filed May 20, 2025 (File No. 333-287446) Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “ Act ”), OraSure Technologies, Inc. (the “ Company ”) hereby requests that the effective date of its Registration Statement on Form S-3 (File No. 333-287446) (the “ Registration Statement ”) be accelerated to May 29, 2025, at 4:05 pm Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Goodwin Procter LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act. Once the Registration Statement is effective, please orally confirm the event with our counsel, Goodwin Procter LLP, by calling Justin M. Platt at (212) 459-7340. If you have any questions regarding this request, please contact Justin M. Platt of Goodwin Procter LLP at (212) 459-7340. Sincerely, ORASURE TECHNOLOGIES, INC. /s/ Carrie Eglinton Manner Carrie Eglinton Manner President, Chief Executive Officer cc: Stefano Taucer, General Counsel, OraSure Technologies, Inc. Rachael M. Bushey, Goodwin Procter LLP Justin M. Platt, Goodwin Procter LLP
2024-12-04 - UPLOAD - ORASURE TECHNOLOGIES INC File: 001-16537
December 4, 2024
Carrie Eglinton Manner
President and Chief Executive Officer
Orasure Technologies, Inc.
220 East First Street
Bethlehem, Pennsylvania 18015
Re:Orasure Technologies, Inc.
Form 8-K
Filed April 12, 2024
File No. 001-16537
Dear Carrie Eglinton Manner:
We have completed our review of your filing. We remind you that the company and
its management are responsible for the accuracy and adequacy of their disclosures,
notwithstanding any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Finance
2024-10-31 - CORRESP - ORASURE TECHNOLOGIES INC
CORRESP 1 filename1.htm CORRESP OraSure Technologies, Inc. 220 East First Street Bethlehem, PA 18015 October 31, 2024 VIA EDGAR Submission U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Irene Paik, James Lopez Re: ORASURE TECHNOLOGIES INC Form 8-K Filed April 12, 2024 File No. 001-16537 Dear Ladies and Gentlemen: OraSure Technologies, Inc. (the “Company”) is submitting this letter in response to comments of the staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”), received by letter dated October 17, 2024 (the “Comment Letter”), relating to the Company’s Current Report on Form 8-K filed with the Commission on April 12, 2024 (the “Form 8-K”). For your convenience, the Staff’s comment is reproduced in bold type below, followed by the Company’s response thereto. Form 8-K filed April 12, 2024 Item 1.05 Material Cybersecurity Incidents, page 1 1. We note your response to our comment that you determined to disclose the cybersecurity incident under Item 1.05 of Form 8-K because you determined that the incident was material based on qualitative considerations. We refer you to the statements in the Form 8-K that you did not “anticipate this incident will have a material impact” on your financial condition and results of operations, and that while you believed you had contained the incident, you “continue[d] to investigate” the matter. Please advise us of your intention to file an amended Form 8-K pursuant to Instruction 2 to Item 1.05. OraSure Technologies, Inc. 220 East First Street Bethlehem, PA 18015 Response: The Company respectfully acknowledges the Staff’s comment. Upon review of Instruction 2 to Item 1.05 of Form 8-K, the Company does not intend to file an amended Form 8-K at this time. Pursuant to Instruction 2 to Item 1.05 of Form 8-K, the Company is required to amend the 8-K if “information called for in Item 1.05(a) is not determined or is unavailable at the time of the required filing . . . . ” The Company advises the Staff that it has substantially completed its investigation of the cybersecurity incident described in the Form 8-K (the “Incident”), but is continuing to monitor the situation and since the filing of the Form 8-K on April 12, 2024, no new information has arisen from such investigation relating to “the material aspects of the nature, scope, and timing of the incident, and the material impact or reasonably likely material impact on the registrant . . . .” As a result, the Company does not believe that amending the Form 8-K is required by Instruction 2 to Item 1.05 of Form 8-K. If new facts arise in the future relating to the Incident, the Company intends to evaluate such new information in light of Instruction 2 to Item 1.05 of Form 8-K and will determine if an amendment to the Form 8-K is necessary without unreasonable delay. If you or any other member of the Staff have any questions regarding the foregoing responses, would like to discuss any of the matters covered in this letter, or otherwise require additional information, please do not hesitate to contact the undersigned at (801) 602-1110 Sincerely, /s/ Carrie Eglinton Manner Carrie Eglinton Manner President, Chief Executive Officer cc: Stefano Taucer, General Counsel, OraSure Technologies, Inc. Rachael M. Bushey, Goodwin Procter LLP Justin M. Platt, Goodwin Procter LLP
2024-10-17 - UPLOAD - ORASURE TECHNOLOGIES INC File: 001-16537
October 17, 2024
Carrie Eglinton Manner
President and Chief Executive Officer
Orasure Technologies, Inc.
220 East First Street
Bethlehem, Pennsylvania 18015
Re:Orasure Technologies, Inc.
Form 8-K
Filed April 12, 2024
File No. 001-16537
Dear Carrie Eglinton Manner:
We have reviewed your June 10, 2024 response to our comment letter and have the
following comment.
Please respond to this letter within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe a
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this letter, we may have additional comments.
Unless we note otherwise, any references to prior comments are to comments in our May 24,
2024 letter.
Form 8-K filed April 12, 2024
Item 1.05 Material Cybersecurity Incidents, page 1
1.We note your response to our comment that you determined to disclose
the cybersecurity incident under Item 1.05 of Form 8-K because you determined that
the incident was material based on qualitative considerations. We refer you to the
statements in the Form 8-K that you did not "anticipate this incident will have a
material impact" on your financial condition and results of operations, and that while
you believed you had contained the incident, you "continue[d] to investigate" the
matter. Please advise us of your intention to file an amended Form 8-K pursuant to
Instruction 2 to Item 1.05.
October 17, 2024
Page 2
Please contact Irene Paik at 202-551-6553 or James Lopez at 202-551-3536 with any
other questions.
Sincerely,
Division of Corporation Finance
Office of Finance
2024-06-10 - CORRESP - ORASURE TECHNOLOGIES INC
CORRESP 1 filename1.htm CORRESP OraSure Technologies, Inc. 220 East First Street Bethlehem, PA 18015 June 10, 2024 VIA EDGAR Submission U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Irene Paik, James Lopez Re: ORASURE TECHNOLOGIES INC Form 8-K Filed April 12, 2024 File No. 001-16537 Dear Ladies and Gentlemen: OraSure Technologies, Inc. (the “Company”) is submitting this letter in response to comments of the staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”), received by letter dated May 24, 2024 (the “Comment Letter”), relating to the Company’s Current Report on Form 8-K filed with the Commission on April 12, 2024 (the “Form 8-K”). For your convenience, the Staff’s comment is reproduced in bold type below, followed by the Company’s response thereto. Form 8-K filed April 12, 2024 Item 1.05 Material Cybersecurity Incidents, page 1 1. We note the statement that you experienced a cybersecurity incident and are still investigating the extent of any sensitive information contained within the accessed systems. Please advise us as to why you determined to file under Item 1.05 of Form 8-K given the statement that the incident has not had a material impact on your operations, financial systems or financial condition, and you do not anticipate that the incident will have a material impact on your financial condition and results of operations moving forward. Response: The Company respectfully acknowledges the Staff’s comment and hereby provides the following explanation. OraSure Technologies, Inc. 220 East First Street Bethlehem, PA 18015 Upon becoming aware of a cybersecurity incident (“Incident”), the Company took steps to contain the Incident and secure its networks and data. Concurrently with these efforts, the Company initiated a process to assess whether the Incident had, or would have, a material impact on the Company’s financial condition or results of operations. As a result of this assessment, the Company concluded that the Incident did not have a material impact on the Company’s operations, financial systems, or its financial condition. However, in accordance with SEC guidance, the Company also considered qualitative factors, such as potential reputational harm and impact on customer and vendor relationships, and the possibility of litigation or regulatory investigations. After the assessment of these qualitative factors, the Company determined that the Incident, including the actions to be taken as a result thereof, such as notification of individuals, vendors, and regulatory agencies, could lead to potential reputational harm or result in litigation or regulatory investigations. As such, the Company determined that “there is a substantial likelihood that a reasonable shareholder would consider it important” (TSC Industries, Inc. v. Northway, Inc., 426 U.S. 438, 449 (1976)) and, therefore, the Company determined that the Incident was material based on qualitative considerations. Accordingly, the Company determined to disclose the Incident under Item 1.05 of Form 8-K. If you or any other member of the Staff have any questions regarding the foregoing responses, would like to discuss any of the matters covered in this letter, or otherwise require additional information, please do not hesitate to contact the undersigned at (801) 602-1110 Sincerely, /s/ Carrie Eglinton Manner Carrie Eglinton Manner President, Chief Executive Officer cc: Stefano Taucer, General Counsel, OraSure Technologies, Inc. Rachael M. Bushey, Goodwin Procter LLP Justin M. Platt, Goodwin Procter LLP
2024-05-24 - UPLOAD - ORASURE TECHNOLOGIES INC File: 001-16537
United States securities and exchange commission logo
May 24, 2024
Carrie Eglinton Manner
President and Chief Executive Officer
Orasure Technologies, Inc.
220 East First Street
Bethlehem, Pennsylvania 18015
Re:Orasure Technologies, Inc.
Form 8-K
Filed April 12, 2024
File No. 001-16537
Dear Carrie Eglinton Manner:
We have reviewed your filing and have the following comment.
Please respond to this letter within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe a
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this letter, we may have additional comments.
Form 8-K filed April 12, 2024
Item 1.05 Material Cybersecurity Incidents, page 1
1.We note the statement that you experienced a cybersecurity incident and are still
investigating the extent of any sensitive information contained within the accessed
systems. Please advise us as to why you determined to file under Item 1.05 of Form 8-K
given the statement that the incident has not had a material impact on your operations,
financial systems or financial condition, and you do not anticipate that the incident will
have a material impact on your financial condition and results of operations moving
forward.
FirstName LastNameCarrie Eglinton Manner
Comapany NameOrasure Technologies, Inc.
May 24, 2024 Page 2
FirstName LastName
Carrie Eglinton Manner
Orasure Technologies, Inc.
May 24, 2024
Page 2
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
Please contact Irene Paik at 202-551-6553 or James Lopez at 202-551-3536 with any
other questions.
Sincerely,
Division of Corporation Finance
Office of Finance
2024-05-02 - UPLOAD - ORASURE TECHNOLOGIES INC File: 001-16537
United States securities and exchange commission logo
May 2, 2024
Kenneth McGrath
Chief Financial Officer
ORASURE TECHNOLOGIES INC
220 East First Street
Bethlehem, Pennsylvania 18015
Re:ORASURE TECHNOLOGIES INC
Form 10-K filed March 11, 2024
Item 2.02 Form 8-K filed February 27, 2024
Response filed May 1, 2024
File No. 001-16537
Dear Kenneth McGrath:
We have completed our review of your filing. We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
2024-05-01 - CORRESP - ORASURE TECHNOLOGIES INC
CORRESP 1 filename1.htm CORRESP OraSure Technologies, Inc. 220 East First Street Bethlehem, PA 18015 May 1, 2024 VIA EDGAR Submission U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Jeanne Baker, Al Pavot Re: ORASURE TECHNOLOGIES INC Form 10-K filed March 11, 2024 Item 2.02 Form 8-K filed February 27, 2024 Response filed April 10, 2024 File No. 001-16537 Dear Ladies and Gentlemen: OraSure Technologies, Inc. (the “Company,” “we,” “us” or “our”) is submitting this letter in response to comments of the staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”), received by letter dated April 26, 2024 (the “Comment Letter”), relating to the Company’s Form 10-K for the fiscal year ended December 31, 2023 filed with the Commission on March 11, 2024 (the “Form 10-K”) and the Company’s Current Report on Form 8-K filed with the Commission on February 27, 2024. For your convenience, the Staff’s comment is reproduced in bold type below, followed by the Company’s response thereto. Item 2.02 Form 8-K filed February 27, 2024 Exhibit 99.1 Orasure Technologies GAAP to Non-GAAP Reconcilation, page 10 1. We note your response to prior comment 2. The underlying facts and circumstances that lead to the inventory reserve adjustments, including your decision to terminate the manufacturing of your Covid-19 products in Thailand, do not appear to be outside the normal course of your operations. With reference to Question 100.01 of the Compliance and Disclosure Interpretations for Non-GAAP Financial Measures, please confirm that you will no longer exclude these inventory impairments from your non-GAAP measures. May 1, 2024 Page 2 Response: We respectfully acknowledge the Staff’s comment and hereby confirm that we will no longer exclude these inventory impairments from our non-GAAP measures in future filings and disclosures. 2. We note that you include an adjustment for accelerated depreciation in your determination of non-GAAP cost of goods sold, gross margin, operating income, net income (loss) and earnings (loss) per share. Confirm that you will no longer exclude accelerated depreciation from your non-GAAP measures. While the useful lives of the machinery and equipment utilized for InteliSwab® production in Thailand were shortened, the assets continued to contribute to revenue generation through the end of their useful lives. Response: We respectfully acknowledge the Staff’s comment and hereby confirm that we will no longer exclude accelerated depreciation from our non-GAAP measures in future filings and disclosures. If you or any other member of the Staff have any questions regarding the foregoing responses, would like to discuss any of the matters covered in this letter, or otherwise require additional information, please do not hesitate to contact the undersigned at (732) 841-5623. Sincerely, /s/ Kenneth McGrath Kenneth McGrath Chief Financial Officer cc: Carrie Eglinton Manner, President and Chief Executive Officer, OraSure Technologies, Inc. Stefano Taucer, General Counsel & Corporate Secretary, OraSure Technologies, Inc. Rachael M. Bushey, Goodwin Procter LLP Justin M. Platt, Goodwin Procter LLP
2024-04-26 - UPLOAD - ORASURE TECHNOLOGIES INC File: 001-16537
United States securities and exchange commission logo
April 26, 2024
Kenneth McGrath
Chief Financial Officer
ORASURE TECHNOLOGIES INC
220 East First Street
Bethlehem, Pennsylvania 18015
Re:ORASURE TECHNOLOGIES INC
Form 10-K filed March 11, 2024
Item 2.02 Form 8-K filed February 27, 2024
Response filed April 10, 2024
File No. 001-16537
Dear Kenneth McGrath:
We have reviewed your April 10, 2024 response to our comment letter and have the
following comments.
Please respond to this letter within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe a
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this letter, we may have additional comments. Unless
we note otherwise, any references to prior comments are to comments in our March 20,
2024 letter.
Item 2.02 Form 8-K filed February 27, 2024
Exhibit 99.1
Orasure Technologies GAAP to Non-GAAP Reconcilation, page 10
1.We note your response to prior comment 2. The underlying facts and circumstances that
lead to the inventory reserve adjustments, including your decision to terminate the
manufacturing of your Covid-19 products in Thailand, do not appear to be outside the
normal course of your operations. With reference to Question 100.01 of the Compliance
and Disclosure Interpretations for Non-GAAP Financial Measures, please confirm that
you will no longer exclude these inventory impairments from your non-GAAP measures.
2.We note that you include an adjustment for accelerated depreciation in your determination
of non-GAAP cost of goods sold, gross margin, operating income, net income (loss) and
FirstName LastNameKenneth McGrath
Comapany NameORASURE TECHNOLOGIES INC
April 26, 2024 Page 2
FirstName LastName
Kenneth McGrath
ORASURE TECHNOLOGIES INC
April 26, 2024
Page 2
earnings (loss) per share. Confirm that you will no longer exclude accelerated depreciation
from your non-GAAP measures. While the useful lives of the machinery and equipment
utilized for InteliSwab® production in Thailand were shortened, the assets continued to
contribute to revenue generation through the end of their useful lives.
Please contact Jeanne Baker at 202-551-3691 or Al Pavot at 202-551-3738 if you have
questions regarding comments on the financial statements and related matters.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
2024-04-10 - CORRESP - ORASURE TECHNOLOGIES INC
CORRESP 1 filename1.htm CORRESP OraSure Technologies, Inc. 220 East First Street Bethlehem, PA 18015 April 10, 2024 VIA EDGAR Submission U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Jeanne Baker, Al Pavot Re: ORASURE TECHNOLOGIES INC Form 10-K filed March 11, 2024 Item 2.02 Form 8-K filed February 27, 2024 File No. 001-16537 Dear Ladies and Gentlemen: OraSure Technologies, Inc. (the “Company,” “we,” “us” or “our”) is submitting this letter in response to comments of the staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”), received by letter dated March 20, 2024 (the “Comment Letter”), relating to the Company’s Form 10-K for the fiscal year ended December 31, 2023 filed with the Commission on March 11, 2024 (the “Form 10-K”) and the Company’s Current Report on Form 8-K filed with the Commission on February 27, 2024. For your convenience, the Staff’s comment is reproduced in bold type below, followed by the Company’s response thereto. Form 10-K filed March 11, 2024 Inventories, page 66 1. Given your disclosure that you expect a significant decline in COVID-19 revenues during 2024, please disclose how much of your ending inventory balance is comprised of COVID-19 testing products. Disclose also how much of that inventory is expired, if any. Response: The Company respectfully acknowledges the Staff’s comment and in response to the Staff’s comment advises that as of December 31, 2023, the Company’s COVID-19 inventory balance was $15.7 million, representing 33% of its total inventory as of that date. Total expired COVID-19 inventory as of December 31, 2023 was minimal with a value of $0.1 million. April 10, 2024 Page 2 Item 2.02 Form 8-K filed February 27, 2024 Exhibit 99.1 OraSure Technologies GAAP to Non-GAAP Reconciliation, page 10 2. We note that you include an adjustment for inventory reserve for excess levels in your determination of Non-GAAP cost of goods sold, gross margin, operating income, net income(loss) and earnings(loss) per share. This adjustment appears to be part of the normal course of your operations and therefore inconsistent with Question 100.01 of the Compliance and Disclosure Interpretations on Non-GAAP Financial Measures. Please advise or revise to no longer include this adjustment in your determination of your non- GAAP measures. Response: The Company respectfully acknowledges the Staff’s comment and advises that it considered the guidance set forth in Question 100.01 in the SEC Staff’s Compliance and Disclosure Interpretations on Non-GAAP Financial Measures. The Company advises the Staff that Supplemental non-GAAP financial measures are used internally in our assessment of performance and in defining target metrics for our management compensation plans. While we believe these metrics are useful supplemental information, we highlight in our disclosures that the non-GAAP financial measures presented should not be considered as a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. In providing non-GAAP financial measures, we acknowledge the authoritative guidance regarding the use of non-GAAP Financial measures in Regulation G, S-K Item 10(e) and Instruction 2 to Item 2.02, in addition to the Staff’s Compliance and Disclosure Interpretations on Non-GAAP Financial Measures, specifically Question 100.1. In accordance with that guidance, we do not include adjustments for items that we may believe represent normal, recurring, cash operating expenses necessary for our operations. We included an adjustment for inventory reserve for excess levels of $3.8 million in our non-GAAP financial measures, which consists of the following inventory reserve items which we consider non-recurring. In the second quarter of 2023, we terminated the manufacturing of our COVID-19 products in Thailand and on-shored production to our facilities located in Bethlehem, Pennsylvania. The COVID-19 inventory in Thailand was reserved as it included component parts for our COVID-19 products manufactured in Thailand and there was a reduction of demand for such products. Due to the termination of Thailand COVID-19 production, we recorded a $1.8 million excess inventory reserve. The vast majority of this reserved inventory was physically scrapped by the end of 2023. In the fourth quarter of 2023, we reserved COVID-19 raw materials of $2.0 million which, based on expected future demand, would likely expire prior to sale. April 10, 2024 Page 3 Both inventory reserve adjustments were associated with the Company’s COVID-19 product line and are not considered part of our core business. We expect the COVID-19 business to continue to decline to levels in which it is not expected to be a material contributor to the Company’s operations or financial results. As we have described above, we do not believe the expense associated with the COVID-19 inventory reserve for excess levels to be normal, recurring, cash operating expenses necessary for our core operations. To further support this presentation, we note that the excess reserves included as a non-GAAP adjustment did not include specific reserves for inventories associated with our other product lines which approximated an additional $3.3 million nor did it include our general inventory reserve amount of $1.9 million. As such, we believe adjusting for inventory reserve for excess levels associated with our COVID-19 product line within our non-GAAP financial measures provides useful supplemental information regarding the core business trends and performance of our ongoing core business. However, in any future non-GAAP adjustment for inventory reserve for excess levels expense, we will provide additional disclosure to clarify that these costs are not normal, recurring expenses necessary for our core business and that such costs relate to our COVID-19 products. If you or any other member of the Staff have any questions regarding the foregoing responses, would like to discuss any of the matters covered in this letter, or otherwise require additional information, please do not hesitate to contact the undersigned at (732) 841-5623 Sincerely, /s/ Kenneth McGrath Kenneth McGrath Chief Financial Officer cc: Carrie Eglinton Manner, President and Chief Executive Officer, OraSure Technologies, Inc. Stefano Taucer, General Counsel & Corporate Secretary, OraSure Technologies, Inc. Rachael M. Bushey, Goodwin Procter LLP Justin M. Platt, Goodwin Procter LLP
2024-03-20 - UPLOAD - ORASURE TECHNOLOGIES INC File: 001-16537
United States securities and exchange commission logo
March 20, 2024
Kenneth McGrath
Chief Financial Officer
ORASURE TECHNOLOGIES INC
220 East First Street
Bethlehem , Pennsylvania 18015
Re:ORASURE TECHNOLOGIES INC
Form 10-K filed March 11, 2024
Item 2.02 Form 8-K filed February 27, 2024
File No. 001-16537
Dear Kenneth McGrath:
We have limited our review of your filing to the financial statements and related
disclosures and have the following comments.
Please respond to this letter within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe a
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this letter, we may have additional comments.
Form 10-K filed March 11, 2024
Inventories, page 66
1.Given your disclosure that you expect a significant decline in COVID-19 revenues during
2024, please disclose how much of your ending inventory balance is comprised of
COVID-19 testing products. Disclose also how much of that inventory is expired, if any.
Item 2.02 Form 8-K filed February 27, 2024
Exhibit 99.1
OraSure Technologies GAAP to Non-GAAP Reconciliation, page 10
2.We note that you include an adjustment for inventory reserve for excess levels in your
determination of Non-GAAP cost of goods sold, gross margin, operating income, net
income(loss) and earnings(loss) per share. This adjustment appears to be part of the
normal course of your operations and therefore inconsistent with Question 100.01 of the
Compliance and Disclosure Interpretations on Non-GAAP Financial Measures. Please
FirstName LastNameKenneth McGrath
Comapany NameORASURE TECHNOLOGIES INC
March 20, 2024 Page 2
FirstName LastName
Kenneth McGrath
ORASURE TECHNOLOGIES INC
March 20, 2024
Page 2
advise or revise to no longer include this adjustment in your determination of your non-
GAAP measures.
In closing, we remind you that the company and its management are responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or
absence of action by the staff.
Please contact Jeanne Baker at 202-551-3691 or Al Pavot at 202-551-3738 with any
questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
2022-05-18 - CORRESP - ORASURE TECHNOLOGIES INC
CORRESP 1 filename1.htm CORRESP OraSure Technologies, Inc. 220 East First Street Bethlehem, Pennsylvania 18015 May 18, 2022 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street NE Washington, D.C. 20549 Attn: Michael Davis and Celeste Murphy Re: OraSure Technologies, Inc. Registration Statement on Form S-3 Filed February 10, 2022 (File No. 333-262633) Ladies and Gentlemen: OraSure Technologies, Inc. (the “Company”) filed as correspondence via EDGAR on May 13, 2022, a letter in which the Company requested the acceleration of the effective date of the Company’s Registration Statement on Form S-3 (File No. 333-262633) (the “Registration Statement”) for May 17, 2022 at 4:00 p.m. Eastern time. The Company is no longer requesting that such Registration Statement be declared effective at this time and we hereby formally withdraw our request for acceleration of the effective date. Please contact Jennifer Porter of Troutman Pepper Hamilton Sanders LLP, counsel to the Company, at (215) 981-4339 to provide notice of effectiveness or if you have any questions or comments concerning this request. Very truly yours, ORASURE TECHNOLOGIES, INC. By: /s/ Agnieszka Gallagher Name: Agnieszka Gallagher Title: Senior Vice President, General Counsel and Secretary
2022-05-18 - CORRESP - ORASURE TECHNOLOGIES INC
CORRESP 1 filename1.htm CORRESP OraSure Technologies, Inc. 220 East First Street Bethlehem, Pennsylvania 18015 May 18, 2022 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street NE Washington, D.C. 20549 Attn: Michael Davis and Celeste Murphy Re: OraSure Technologies, Inc. Registration Statement on Form S-3 Filed February 10, 2022 (File No. 333-262633) Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, OraSure Technologies, Inc. (the “Company”) hereby requests that the effective date of the Company’s Registration Statement on Form S-3 (File No. 333-262633) (the “Registration Statement”) be accelerated so that the Company’s Registration Statement will become effective at 4:00 PM, Eastern Time, on May 20, 2022, or as soon thereafter as is practicable. Please contact Jennifer Porter of Troutman Pepper Hamilton Sanders LLP, counsel to the Company, at (215) 981-4339 to provide notice of effectiveness or if you have any questions or comments concerning this request. Very truly yours, ORASURE TECHNOLOGIES, INC. By: /s/ Agnieszka Gallagher Name: Agnieszka Gallagher Title: Senior Vice President, General Counsel and Secretary
2022-05-13 - CORRESP - ORASURE TECHNOLOGIES INC
CORRESP 1 filename1.htm CORRESP OraSure Technologies, Inc. 220 East First Street Bethlehem, Pennsylvania 18015 May 13, 2022 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street NE Washington, D.C. 20549 Attn: Michael Davis and Celeste Murphy Re: OraSure Technologies, Inc. Registration Statement on Form S-3 Filed February 10, 2022 (File No. 333-262633) Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, OraSure Technologies, Inc. (the “Company”) hereby requests that the effective date of the Company’s Registration Statement on Form S-3 (File No. 333-262633) (the “Registration Statement”) be accelerated so that the Company’s Registration Statement will become effective at 4:00 PM, Eastern Time, on May 17, 2022, or as soon thereafter as is practicable. Please contact Jennifer Porter of Troutman Pepper Hamilton Sanders LLP, counsel to the Company, at (215) 981-4339 to provide notice of effectiveness or if you have any questions or comments concerning this request. Very truly yours, ORASURE TECHNOLOGIES, INC. By: /s/ Agnieszka Gallagher Name: Agnieszka Gallagher Title: Senior Vice President, General Counsel and Secretary
2022-02-17 - UPLOAD - ORASURE TECHNOLOGIES INC
United States securities and exchange commission logo
February 17, 2022
Agnieszka Gallagher
Senior Vice President, General Counsel and Secretary
ORASURE TECHNOLOGIES INC
220 East First Street
Bethlehem, Pennsylvania 18015
Re:ORASURE TECHNOLOGIES INC
Registration Statement on Form S-3
Filed February 10, 2022
File No. 333-262633
Dear Agnieszka Gallagher:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Michael Davis at 202-551-4385 or Celeste Murphy at 202-551-3257 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jennifer Porter
2019-02-11 - CORRESP - ORASURE TECHNOLOGIES INC
CORRESP 1 filename1.htm CORRESP February 11, 2019 VIA EDGAR Division of Corporation Finance U.S. Securities & Exchange Commission 100 F Street, NE Washington, D.C. 20549 Attention: Heather Percival Re: OraSure Technologies, Inc. Registration Statement on Form S-3 (File No. 333-228877) Dear Commissioners: Pursuant to Rule 461 under the Securities Act of 1933, as amended, OraSure Technologies, Inc., a Delaware corporation (the “Company”), hereby respectfully requests acceleration of the effective date of its Registration Statement on Form S-3 (File No. 333-228877) (the “Registration Statement”), so that such Registration Statement may be declared effective at 4:30 p.m. (Eastern Time) on February 13, 2019 or as soon as practicable thereafter. We request that we be notified of such effectiveness by a telephone call to the undersigned at (610) 882-1820, Ext. 1600, or Stephen Leitzell of Dechert LLP at (215) 994-2621, and that such effectiveness also be confirmed in writing. Very truly yours, OraSure Technologies, Inc. By: /s/ Jack E. Jerrett Name: Jack E. Jerrett Title: Senior Vice President, General Counsel and Secretary cc: Stephen Leitzell, Dechert LLP
2019-02-05 - UPLOAD - ORASURE TECHNOLOGIES INC
February 5, 2019
Jack E. Jerrett
General Counsel
OraSure Technologies, Inc.
220 East First Street
Bethlehem, Pennsylvania 18015
Re:OraSure Technologies, Inc.
Registration Statement on Form S-3
Filed December 18, 2018
File No. 333-228877
Dear Mr. Jerrett:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Heather Percival at 202-551-3498 with any questions.
Sincerely,
Division of Corporation Finance
Office of Electronics and Machinery
cc: Stephen M. Leitzell
2015-12-16 - CORRESP - ORASURE TECHNOLOGIES INC
CORRESP 1 filename1.htm Correspondence December 16, 2015 VIA EDGAR Securities and Exchange Commission 100 F Street, N.E. Washington, DC 20549 Attention: Mr. Tom Jones Re: OraSure Technologies, Inc. Registration Statement on Form S-3 (File No. 333-208505) Dear Commissioners: Pursuant to Rule 461 under the Securities Act of 1933, as amended, OraSure Technologies, Inc., a Delaware corporation (the “Company”), hereby respectfully requests acceleration of the effective date of its Registration Statement on Form S-3 (File No. 333-208505) (the “Registration Statement”), so that such Registration Statement may be declared effective at 4:00 p.m. (Eastern Time) on December 18, 2015 or as soon as practicable thereafter. We request that we be notified of such effectiveness by a telephone call to the undersigned at (610) 882-1820, Ext. 1600, or Stephen Leitzell of Dechert LLP at (215) 994-2621, and that such effectiveness also be confirmed in writing. The Company hereby acknowledges that (i) should the Securities and Exchange Commission (the “Commission”) or the staff of the Commission (the “Staff”), acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; (ii) the action of the Commission or the Staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and (iii) the Company may not assert Staff comments or the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Very truly yours, OraSure Technologies, Inc. By: /s/ Jack E. Jerrett Name: Jack E. Jerrett Title: Senior Vice President, General Counsel and Secretary cc: Amanda Ravitz, SEC, Division of Corporation Finance Stephen Leitzell, Dechert LLP 220 East First Street, Bethlehem, PA 18015-1360 Phone: 610.882.1820 www.orasure.com
2015-12-15 - UPLOAD - ORASURE TECHNOLOGIES INC
Mail Stop 3030
December 15, 2015
Jack E. Jerrett, Esquire
Senior Vice President
OraSure Technologies, Inc.
220 East First Street
Bethlehem, Pennsylvania 18015
Re: OraSure Technologies, Inc.
Registration Statement on Form S -3
Filed December 11, 2015
File No. 333-208505
Dear Mr. Jerrett:
This is to advise you that we have not reviewed and will not review your registration
statement .
We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain that the filing includes the information the Securities Act of 193 3 and
all applicable Securities Act rules require. Since the company and its management are in
possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.
In the event you request acceleration of the effective date of the pending regist ration
statement, please provide a written statement from the company acknowledging that:
should the Commission or the staff, acting pursuant to delegated authority, declare the
filing effective, it does not foreclose the Commission from taking any action wit h respect
to the filing;
the action of the Commission or the staff, acting pursuant to delegated authority, in
declaring the filing effective, does not relieve the company from its full responsibility for
the adequacy and accuracy of the disclosure in th e filing; and
the company may not assert staff comments and the declaration of effectiveness as a
defense in any proceeding initiated by the Commission or any person under the federal
securities laws of the United States.
Jack E. Jerrett
OraSure Technologies, Inc.
December 15, 2015
Page 2
Please refer to Rules 460 and 461 regarding requests for acceleration . We will consider a
written request for acceleration of the effective date of the registration statement as confirmation
of the fact that those requesting acceleration are aware of their respective responsibilities under
the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed
public offering of the registered securities .
Please contact Tom Jones at (202) 551 -3602 with any questions.
Sincerely,
/s/ Tom Jones for
Amanda Ravitz
Assistant Director
Office of Electronics and Machinery
cc: Stephen Leitzell, Esq.
2015-11-09 - UPLOAD - ORASURE TECHNOLOGIES INC
Mail Stop 3030 November 9, 2015 Via E -mail Douglas A. Michels President and Chief Executive Officer OraSure Technologies, Inc. 220 East First Street Bethlehem, Pennsylvania 18015 Re: OraSure Technologies, Inc. Form 10-K for the fiscal year ended December 31, 2014 Filed March 12 , 2015 File No. 001-16537 Dear M r. Michels : We have completed our review of your filings. We remind you that our comments or changes to disclosure in response to our comments do not foreclose the Commission from taking any action with respect to the company or the filings and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filings to be certain that the filings include the information the Securities Exchange Act of 1934 and all applicable rules require. Sincerely, /s/ Martin James Martin James Senior Assistant Chief Accountant Office of Electronics and Machinery
2015-10-29 - CORRESP - ORASURE TECHNOLOGIES INC
CORRESP 1 filename1.htm Correspondence October 29, 2015 VIA EDGAR Mr. Martin James Senior Assistant Chief Accountant, Office of Electronics and Machinery U.S. Securities and Exchange Commission Division of Corporation Finance Mailstop 3030 Washington, D.C. 20549 Re: OraSure Technologies, Inc. (the “Company”) Form 10-K for the fiscal year ended December 31, 2014 Filed March 12, 2015 File No. 001-16537 Dear Mr. James: This letter responds to the comments of the staff (“Staff”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”) contained in your letter dated September 30, 2015 with respect to the above-referenced Form 10-K for the fiscal year ended December 31, 2014. Below we have reprinted these comments in bold, followed by our responses. Staff Comment 1: We note that you reduce your revenues from the OraQuick® In-Home HIV test for customer allowances for cooperative advertising, discounts, rebates and chargebacks. Please describe to us the significant terms and conditions of these programs and how you account for these programs under ASC 605-50 and any other applicable authoritative literature. Also address how you determined the proper income statement classification for each program under ASC 605-50-45. Company Response: We began selling our OraQuick® In-Home HIV test in 2012, primarily through the three largest US retail pharmacy chains. This product is the first and only rapid HIV test available for sale directly to consumers in the over-the-counter market. We have executed sales agreements with each of our retail-trade customers which provide for trade allowances for cooperative advertising, discounts, rebates or chargebacks. Each of the sales agreements requires the Company to provide these customers with a fixed percentage trade allowance based upon the dollar-value of their individual purchases. Each customer agreement defines this allowance differently, either as a chargeback or allowance for cooperative advertising, and each customer deducts this allowance from the Company’s invoice upon payment. Our initial sales agreements were for a one-year term, with annual renewal options. There is no firm commitment on behalf of the retail trade customers to provide the Company with any form of benefit in exchange for their allowance percentage, nor does the customer have any minimum purchase volume 220 East First Street, Bethlehem, PA 18015-1360 Phone: 610.882.1820 ● Fax: 610.882.2275 www.orasure.com commitment to the Company. Additionally, the Company does not receive, nor is it entitled to receive, any documentation or information pertaining to any in-store advertising which the customer may elect to provide. We have considered the guidance provided in Financial Accounting Standards Board’s Accounting Standards Codification (“ASC”) 605-50, Revenue Recognition, Customer Payments and Incentives, as well as the presentation guidance provided in ASC 605-50-45, Other Presentation Matters. In accordance with the general rule set forth in ASC 605-50-45-2, we have concluded that the cash consideration which the Company is giving to its retail trade customers in the form of trade allowances represents a reduction in the selling price of our product and therefore should be characterized as a reduction of revenue when recognized in the Company’s income statement. We based this conclusion on the fact that the allowance is linked to a single sales transaction (multiple sales transactions are not required in order for the customer to receive the consideration) and the Company does not receive, nor will it receive, any identifiable benefit (goods or services) in exchange for the allowance given to the customer. Staff Comment 2: We note that in connection with your Master Program Services and Co-Promotion Agreement with AbbVie Bahamas Ltd., you are eligible to receive up to $75 million in exchange for exclusive rights and other services. We further note that you are recognizing the $75 million ratably on a monthly basis over the life of the agreement. Please address the following: • Describe the “other services” you must provide under the agreement and explain how the performance of these services impacted your revenue recognition. • Explain to us any conditions that must be met in order to receive the full $75 million. • Explain to us how you determined that it is appropriate to recognize the full $75 million over the term of the agreement. • Tell us the payment terms for the $75 million. Company Response: Under the terms of the Master Program Services and Co-Promotion Agreement (the “Agreement”) with AbbVie Bahamas Ltd. (“AbbVie”), the Company is required to design, develop, implement, and administer a proprietary patient care database (the “Patient Care Database”). This Patient Care Database, which is being compiled by the Company over the term of the Agreement, is used to collect information related to individuals who test positive for Hepatitis C (“HCV”), in certain US markets, with the Company’s OraQuick® HCV Rapid Antibody Test (the “OraQuick® HCV Test”). The Company is responsible for selling the OraQuick® HCV Test into these markets. AbbVie does not purchase any devices from the Company, nor is it eligible to receive any royalty or payment related to units sold by the Company. Individuals who are enrolled in the Patient Care Database can choose to opt into a patient care model, in which they will receive community outreach services related to HCV education, testing, diagnosis and treatment needs directly from AbbVie or AbbVie’s vendor (the “Care Model”). The Company is required to maintain the security of the Patient Care Database and the patient information contained therein, and to provide ongoing training to representatives of AbbVie on access to and use of the database. The Company is also obligated to obtain completed consent and heath care marketing authorization forms from individuals who enroll in the Patient Care Database. The Company is required to provide AbbVie or its representatives with ongoing training on the use of the Company’s -2- OraQuick® HCV Test, and to participate in current and future co-promotion activities for certain target markets in the United States in order to effectuate enrollment into the Patient Care Database. During the term of the Agreement, the Company is required to develop and establish the Patient Care Database on behalf of, and for the sole and exclusive benefit of, AbbVie. The Agreement specifically grants AbbVie exclusive rights with respect to the Patient Care Database, as it is created by the Company. The term of the Agreement commenced on June 10, 2014 and will continue until December 31, 2019, unless terminated sooner in accordance with its terms. The Agreement also requires that AbbVie, among other things, utilize commercially reasonable efforts to co-promote the OraQuick® HCV Test in certain US markets and to make the Care Model available to patients in those markets. If, during the term of the Agreement, the Company decides to commercialize a future product other than the OraQuick® HCV Test for the point-of-care detection of HCV antibodies in humans, AbbVie shall have a right of first refusal to co-promote that future product in the markets covered by the Agreement (“Right of First Refusal”). In consideration for the design and development of the Patient Care Database, the exclusive rights granted to AbbVie therein, and the Right of First Refusal, AbbVie is required to pay the Company an aggregate fee of $75 million (the “Database Establishment, Ownership and Exclusivity Fee”), subject to the terms of the Agreement. The Agreement provides that the Database Establishment, Ownership and Exclusivity Fee shall accrue and be earned ratably on a daily basis (and recorded monthly) by the Company during the period from the June 10, 2014 effective date of the Agreement through the end of the term of the Agreement on December 31, 2019. The Database Establishment, Ownership and Exclusivity Fee is non-refundable, non-creditable and not subject to setoff, except where the Agreement is terminated prior to the end of its term by the Company for convenience or by AbbVie as a result of a material breach by the Company, in which case AbbVie is entitled to receive a refund of the amount, if any, of the Database, Establishment, Ownership, and Exclusivity Fees which has been paid to the Company but which is unearned by the Company at the date of termination, as defined in the Agreement. If the Agreement is terminated prior to the end of its term in accordance with its terms (including by either party for material breach, for convenience on or after December 31, 2016, on account of the insolvency of the other party or, in certain circumstances, by AbbVie as a result of the Company’s change of control), AbbVie shall no longer be obligated to make any future payments of the Database Establishment, Ownership and Exclusivity Fee and may pay less than the full Fee. The foregoing describes certain terms of the Agreement and is qualified by reference to the entire Agreement. We have applied the guidance provided in ASC 605, Revenue Recognition. We believe the Company’s performance obligation under the Agreement is to transfer to AbbVie a series of services and rights that are substantially the same and have the same pattern of transfer over the same duration, namely the term of the Agreement ending on December 31, 2019. These services and rights consist of the development, compilation, and ongoing maintenance of the Patient Care Database for the exclusive use of AbbVie and the ongoing availability of the Right of First Refusal. We believe these services and rights represent a single-unit of accounting because they do not have value to AbbVie on a standalone basis. As such, we have allocated all of the Agreement consideration to this single unit of accounting. We have concluded that the Company satisfies its performance obligation by creating the Patient Care Database over the term of the Agreement. Given that the Company’s performance obligation is ongoing and extends through December 31, 2019, and there are no other conditions to receipt of the Database Establishment, Ownership and Exclusivity Fee, including no minimum number of individuals that must be enrolled into the Patient Care Database, we believe it is appropriate to recognize the $75 million aggregate fee ratably on a monthly basis over the life of the Agreement. Other than the Company’s ongoing performance, and so long as the Agreement is not terminated early in accordance with its terms, -3- there are no other conditions which must be met in order for the Company to receive the full $75 million under the terms of the Agreement. We concluded that it is appropriate to recognize the full $75 million over the term of the Agreement. The Company believes the $75 million represents the fixed amount of consideration which the Company is entitled to receive in exchange for transferring the promised services and rights to AbbVie. The Agreement also provides for additional variable consideration payable upon the achievement of certain performance-based milestones based on the number of HCV positive patients enrolled in the Patient Care Database in a contract year. However, since the Company does not have any historical experience in achieving the type of performance-based milestones contained in the Agreement, the Company concluded that it is appropriate to include no variable compensation in the measurement of overall contract consideration. Regarding the payment terms associated with the $75 million, an initial payment of $15 million was received from AbbVie within 30 days following the signing of the Agreement in June 2014. Pursuant to the Agreement, the remaining $60 million is scheduled to be paid in a series of payments that result in equivalent amounts of fixed compensation being paid in each contract year. As a result, the Company initially records the cash payments received from AbbVie as deferred revenue and then recognizes the aggregate $75 million ratably on a monthly basis as it satisfies its performance obligation over the term of the Agreement. Based upon the timing of the payments in each year, the risk of any future revenue reversal is non-existent because the aggregate cash received from AbbVie will equal or exceed any time-based revenue recognition for the Database Establishment, Ownership and Exclusivity Fee. As noted, these cash payments are non-refundable, non-creditable, and not subject to setoff except in very limited circumstances, which are within the Company’s control and not likely to occur. * * * * * In connection with the foregoing responses, the Company acknowledges that (i) the Company is responsible for the adequacy and accuracy of the disclosure in its filings; (ii) Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the filing; and (iii) the Company may not assert Staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please do not hesitate to contact the undersigned (610-882-1820, ext. 1477) if you have any questions or if we can provide any further information that would be helpful to the Staff. Sincerely, /s/ Mark L. Kuna Mark L. Kuna Senior Vice President, Finance and Controller (Principal Accounting Officer) cc: D. Michels, President and Chief Executive Officer R. Spair, Chief Operating Officer and Chief Financial Officer J. Jerrett, Senior Vice President, General Counsel and Secretary M. Celano, Chairman, Audit Committee J. Kalinowski, KPMG LLP -4- S. Leitzell, Dechert LLP -5-
2015-09-30 - UPLOAD - ORASURE TECHNOLOGIES INC
Mail Stop 3030 September 30, 2015 Via E -mail Douglas A. Michels President and Chief Executive Officer OraSure Technologies, Inc. 220 East First Street Bethlehem, Pennsylvania 18015 Re: OraSure Technologies, Inc. Form 10-K for the fiscal year ended December 31, 2014 Filed March 12 , 2015 File No. 001-16537 Dear M r. Michels : We have reviewed your filing and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to these comments within ten busine ss days by providing the requested information or advis e us as soon as possible when you will respond. If you do not believe our comments apply to your facts and circumstances, please tell us why in your response. After reviewing your response to these comments , we may have additional comments. Form 10 -K for the Fiscal Year Ended December 31, 2014 Item 8. Financial Statements Note 2. Summary of Significant Accounting Policies Revenue Recognition, page F -10 1. We note that you reduce your revenues from the OraQuick® In-Home HIV test for customer allowances for cooperative advertising, discounts, rebates and chargebacks. Please describe to us the significant terms and conditions of these programs and how you account for these programs under ASC 605 -50 and any other applicable authoritative literat ure. Also address how you determined the proper income statement classification for each program under ASC 605 -50-45. Douglas A. Michels OraSure Technologies, Inc. September 30, 2015 Page 2 2. We note that in connection with your Master Program Services and Co -Promotion Agreement with AbbVie Bahamas Ltd., you are eligible to re ceive up to $75 million in exchange for exclusive rights and other services. We further note that you are recognizing the $75 million ratably on a monthly basis over the life of the agreement. Please address the following: Describe the “other services” you must provide under the agreement and explain how the performance of these services impacted your revenue recognition. Explain to us any conditions that must be met in order to receive the full $75 million. Explain to us how you determined that it is appropriate to recognize the full $75 million over the term of the agreement. Tell us the payment terms for the $75 million. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filin g includes the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In responding to our comments, please provide a written statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the filing; staff commen ts or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any pe rson under the federal securities laws of the United States. You may contact Eric Atallah at (202) 551 -3663 or Kate Tillan, Assistant Chief Accountant , at (202) 551 -3604 if you have questions regarding comments on the financial statements and related matt ers. You may also reach me at (202) 551 -3671. Sincerely, /s/ Kate Tillan for Martin James Senior Assistant Chief Accountant Office of Electronics and Machinery
2012-12-20 - CORRESP - ORASURE TECHNOLOGIES INC
CORRESP 1 filename1.htm Acceleration Request December 20, 2012 VIA EDGAR Securities and Exchange Commission 100 F Street, N.E. Washington, DC 20549 Attention: Mr. Russell Mancuso Re: OraSure Technologies, Inc. Registration Statement on Form S-3 (File No. 333-184190) Dear Commissioners: Pursuant to Rule 461 under the Securities Act of 1933, as amended, OraSure Technologies, Inc., a Delaware corporation (the “Company”), hereby respectfully requests acceleration of the effective date of its Registration Statement on Form S-3 (File No. 333-184190), as amended, so that such Registration Statement may be declared effective at 4:00 p.m. (Eastern Time) on December 20, 2012 or as soon as practicable thereafter. We request that we be notified of such effectiveness by a telephone call to the undersigned at (610) 882-1820, Ext. 3176, or Ella DeTrizio of Dechert LLP at (609) 955-3211, and that such effectiveness also be confirmed in writing. The Company hereby acknowledges that (i) should the Securities and Exchange Commission (the “Commission”) or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; (ii) the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and (iii) the Company may not assert Staff comments or the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Very truly yours, OraSure Technologies, Inc. By: /s/ Jack E. Jerrett Name: Jack E. Jerrett Title: Senior Vice President, General Counsel and Secretary cc: Ella DeTrizio, Dechert LLP
2012-12-19 - CORRESP - ORASURE TECHNOLOGIES INC
CORRESP 1 filename1.htm Correspondence December 19, 2012 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, D.C. 20549 Attn: Mr. Russell Mancuso RE: OraSure Technologies, Inc. Amendment No. 2 to Registration Statement on Form S-3 Filed on December 17, 2012 File No. 333-184190 Ladies and Gentlemen: On December 17, 2012, OraSure Technologies, Inc. (the “Company”) filed with the Securities and Exchange Commission (the “Commission”) Amendment No. 2 to its Registration Statement on Form S-3 (as amended, the “Registration Statement”). As discussed with Mr. Russell Mancuso today, we hereby supplementally respond to certain comments raised by the staff (the “Staff”) of the Commission in the letter dated December 11, 2012 from Mr. Mancuso to Mr. Douglas A. Michels, on behalf of the Company. For your convenience, the relevant Staff comments are included in this letter and are followed by the applicable supplemental response. All terms used but not defined herein have the meanings assigned to such terms in the Registration Statement. Exhibit 5.1 2. Refer to your response to our prior comment 3. Please tell us what law governs the rights. In this regard, we note that this exhibit does not address Delaware contract law. Response: In response to the Staff’s comment 2, the Company, in its letter to the Staff dated December 17, 2012, previously confirmed for the Staff that Delaware law would govern the rights. On behalf of the Company, Dechert LLP respectfully wishes to further clarify for the Staff that the rights would be issued in accordance with Section 157 of the General Corporation Law of the State of Delaware, which provides that the terms upon which any securities may be acquired from a corporation upon the exercise of rights shall be such “as shall be stated in the certificate of incorporation, or in a resolution adopted by the board of directors … and …be set forth in or incorporated by reference in the instrument or instruments evidencing such rights.” Moreover, the Company contemplates that the rights would be issued pursuant to subscription certificates distributed as a scrip dividend and would not be issued pursuant United States Securities and Exchange Commission December 19, 2012 Page 2 of 2 to a rights agreement or other contract. Therefore, Dechert LLP respectfully submits that the appropriate law for purposes of its opinion relating to the rights is the General Corporation Law of the State of Delaware, which law is appropriately covered in its opinion filed as Exhibit 5.1 to the Registration Statement. Additionally, as the Company has previously confirmed for the Staff for purposes of Dechert LLP’s legal opinion, the General Corporation Law of the State of Delaware includes “all applicable Delaware statutory provisions and reported judicial decisions interpreting those laws.” Dechert LLP further advises the Staff that it has previously addressed the issue raised in comment 2 above with the Staff in connection with similar comments received by another Registrant and has resolved such issue in this manner to the Staff’s satisfaction. As discussed with Mr. Mancuso, Dechert LLP respectfully further advises the Staff that it is contemplated that the warrants and units would be issued pursuant to an applicable valid and binding warrant or unit agreement, neither of which is currently filed as an exhibit to the Registration Statement, and that clause (xiii) of its legal opinion has assumed that “each agreement or contract referred to herein but not filed as an exhibit to the Registration Statement as of the date hereof shall be governed by the laws of the State of New York.” Accordingly, the appropriate law for purposes of the opinions relating to warrants or units is the law of the State of New York, which law is also appropriately covered in Dechert LLP’s legal opinion. * * * * * If you have any questions, please feel free to contact the undersigned at 609.955.3211. Thank you for your cooperation and prompt attention to this matter. Sincerely, /s/ Ella DeTrizio Ella DeTrizio cc: Douglas A. Michels, President and Chief Executive Officer, OraSure Technologies, Inc. Jack E. Jerrett, Senior Vice President, General Counsel and Secretary, OraSure Technologies, Inc.
2012-12-11 - UPLOAD - ORASURE TECHNOLOGIES INC
December 11, 2012
Via E -mail
Douglas A. Michels
President and Chief Executive Officer
OraSure Technologies, Inc.
220 East First Street
Bethlehem, PA 18015
Re: OraSure Technologies, Inc.
Amendment No. 1 to Registration Statement on Form S-3
Filed November 30, 2012
File No. 333-184190
Dear Mr. Michels :
We have limited our review of your registration statement to those issues we have
addressed in our comments. In some of our comments, we may ask you to provide us with
information so we may better understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. Where you do not believe our c omments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Prospectus Summary
1. Please tell us why you believe your disclosure added in response to prior comment 1
adequately highlights the magnitude of developments that will cause the anticipated
increase in net loss and the p otential decrease in revenues mentioned in your November
7, 2012 conference call. Also, please provide us your analysis of why you believe
including this information near the end of a 10 -page summary adequately highlights the
issues; refer to Updated S taff Legal Bulletin No. 7 (June 7, 1999) sample comments 28
and 29.
Exhibit 5.1
2. Refer to your response to our prior comment 3. Please tell us what law governs the
rights. In this regard, we note that this exhibit does not address Delaware contract law.
Douglas A. Michels
OraSure Technologies, Inc.
December 11, 2012
Page 2
We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain that the filing includes the information the Securities Act of 1933 and
all applicable Securities Act rules require. Since the company and its management are in
possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.
Notwithstanding our comments, in the event you request acceleration of the effective date
of the pending registration statement please provide a written statement from the company
acknowledging that:
should the Commission or the staff, acting pursuant to delegated authority, declare the
filing effective, it does not foreclose the Commissi on from taking any action with respect
to the filing;
the action of the Commission or the staff, acting pursuant to delegated authority, in
declaring the filing effective, does not relieve the company from its full responsibility for
the adequacy and acc uracy of the disclosure in the filing; and
the company may not assert staff comments and the declaration of effectiveness as a
defense in any proceeding initiated by the Commission or any person under the federal
securities laws of the United States.
Please refer to Rules 460 and 461 regarding requests for acceleration. We will consider a
written request for acceleration of the effective date of the registration statement as confirmation
of the fact that those requesting acceleration are aware of their respective responsibilities under
the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed
public offering of the securities specified in the above registration statement. Please allow
adequate time for us to revie w any amendment prior to the requested effective date of the
registration statement.
Please contact Joseph McCann at (202) 551-6262 or me at (202) 551 -3617 with any
questions.
Sincerely,
/s/ Russell Mancuso
Russell Mancuso
Branch Chief
cc (via email): Ella DeTrizio , Esq. – Dechert LLP
2012-10-18 - UPLOAD - ORASURE TECHNOLOGIES INC
October 18, 2012
Via E -mail
Douglas A. Michels
President and Chief Executive Officer
OraSure Technologies, Inc.
220 East First Street
Bethlehem, PA 18015
Re: OraSure Technologies, Inc.
Registration Statement on Form S-3
Filed September 28, 2012
File No. 333-184190
Dear Mr. Michels :
We have limited our review of your registration statement to those issues we have
addressed in our comments. In some of our comments, we may ask you to provide us with
information so we may better understand your discl osure.
Please respond to this letter by amending your registration statement and providing the
requested information. Where you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell u s why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Who We Are, page 3
1. Please disclose prominently in your prospectus s ummary your history of losses and
accumulated deficit. Quantify these items at least for the periods included in the financial
statements that you incorporate by reference.
Incorporation by Reference, page 36
2. Please refer to Form S -3, Item 12(a)(2), w hich indicates that you are required to
incorporate by reference all Exchange Act reports filed pursuant to Section 13(a) since
the end of the fiscal year covered by your annual report. Given that your most recent
annual report covers the period ending De cember 31, 2011, please revise to incorporate
by reference your Form 8 -K filed on February 27, 2012 or advise.
Douglas A. Michels
OraSure Technol ogies, Inc.
October 18, 2012
Page 2
Exhibit 5.1
3. Please file an opinion that addresses whether the rights are binding obligations of the
registrant under the law of the jurisdictio n governing the rights. Please refer to Section
II.B.1.f of Staff Legal Bulletin No. 19 (Oct. 14, 2011).
4. Refer to the last paragraph on page 6 of this exhibit. The opinion that you file to satisfy
your obligations under Regulation S -K Item 601(b)(5) may not include any limitation on
reliance. Note Section II.B.3.d of Staff Legal Bulletin No. 19 (Oct. 14, 2011). Please file
a revised opinion.
We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be ce rtain that the filing includes the information the Securities Act of 1933 and
all applicable Securities Act rules require. Since the company and its management are in
possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.
Notwithstanding our comments, in the event you request acceleration of the effective date
of the pending registration statement please provide a written statement from the company
acknowledging t hat:
should the Commission or the staff, acting pursuant to delegated authority, declare the
filing effective, it does not foreclose the Commission from taking any action with respect
to the filing;
the action of the Commission or the staff, acting purs uant to delegated authority, in
declaring the filing effective, does not relieve the company from its full responsibility for
the adequacy and accuracy of the disclosure in the filing; and
the company may not assert staff comments and the declaration of effectiveness as a
defense in any proceeding initiated by the Commission or any person under the federal
securities laws of the United States.
Please refer to Rules 460 and 461 regarding requests for acceleration. We will consider a
written request for a cceleration of the effective date of the registration statement as confirmation
of the fact that those requesting acceleration are aware of their respective responsibilities under
the Securities Act of 1933 and the Securities Exchange Act of 1934 as they r elate to the proposed
public offering of the securities specified in the above registration statement. Please allow
adequate time for us to review any amendment prior to the requested effective date of the
registration statement.
Douglas A. Michels
OraSure Technol ogies, Inc.
October 18, 2012
Page 3
Please contact Jose ph McCann at (202) 551-6262 or me at (202) 551 -3617 with any
questions.
Sincerely,
/s/ Russell Mancuso
Russell Mancuso
Branch Chief
cc (via email): Ella DeTrizio , Esq. – Dechert LLP
2009-10-26 - UPLOAD - ORASURE TECHNOLOGIES INC
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
DIVISION OF
CORPORATION FINANCE
Mail Stop 3030
October 26, 2009
VIA U.S. MAIL
Ronald H. Spair Chief Financial Officer
Orasure Technologies, Inc.
220 East First Street Bethlehem, Pennsylvania 18015
Re: Orasure Technologies, Inc.
Form 10-K for the year ended December 31, 2008
Filed March 10, 2009 File No. 001-16537
Dear Mr. Spair:
We have completed our review of your Form 10-K and related filings and do not, at this
time, have any further comments. S i n c e r e l y ,
Jeff Jaramillo A c c o u n t i n g B r a n c h C h i e f
2009-09-29 - CORRESP - ORASURE TECHNOLOGIES INC
CORRESP 1 filename1.htm Correspondence [*Confidential Treatment Requested by OraSure Technologies, Inc.] September 29, 2009 Transmitted Via EDGAR and Facsimile Ms. Julie Sherman Reviewing Accountant Securities and Exchange Commission Division of Corporation Finance 450 Fifth Street, N.W. Washington, D.C. 20549 Re: OraSure Technologies, Inc. (the “Company”) Form 10-K for the Year Ended December 31, 2008 (“10-K Report”) SEC File No. 1-16537 Dear Ms. Sherman: This letter responds to the comments of the staff (“Staff”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”) contained in your letter dated August 31, 2009 (the “Comment Letter”) with respect to the above-referenced 10-K Report. Below we have reprinted these comments in bold, followed by our responses. Comment 1 (Supply and Manufacturing, p.12) Staff Comment: It appears that upon termination of your agreement with BMX you purchased a two-year supply of HIV antigen required to manufacture the Western blot test. In your disclosure, you indicate that your current supply will be sufficient for at least the next several years. Please confirm that you will provide in future filings a more specific estimate as to when you will exhaust your reserves. Alternatively, please tell us why you believe that this information is not material. For instance, if you have made or anticipate being able to make alternative arrangements, please clearly disclose in future filings. Company Response: Supplementally, the Company advises the Staff that since the filing of the 10-K Report, the Company has made arrangements to purchase HIV-1 antigen from a subcontractor that had historically been used by BMX to manufacture this product for resale by BMX to the Company. The Company intends to negotiate a long-term supply contract with this party in the near future. [*Confidential Treatment Requested by OraSure Technologies, Inc.] Consequently, we believe the remaining inventory level following termination of the BMX contract, as described in the 10-K Report, is no longer material or relevant to investors. The Company’s future filings will describe the status of this alternate source of HIV-1 antigen supply. Comment 2 (Domestic Regulations, p.17) Staff Comment: Refer to the penultimate paragraph of this section. With a view toward disclosure in future filings, please explain more fully the significance of the waivers you have acquired. Do the waivers apply to your laboratories or those of your customers or both? Are the waivers subject to certain restrictions? Can they expire? Please clarify. Company Response: We assume this comment refers to the discussion of the waiver for two of our products (i.e., the OraQuick ADVANCE® HIV test and Q.E.D.® rapid alcohol test) under the Clinical Laboratory Improvements Amendments of 1988 (“CLIA”), which appears at the top of page 18 of the 10-K Report. We will clarify in the Company’s future filings that a CLIA waiver is issued for particular tests that meet certain requirements established by the statute and related regulations (i.e., tests that employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible or pose no reasonable risk of harm to the patient if the test is performed incorrectly). A CLIA waiver does not expire. A CLIA waiver is important in that it expands the number of customers that can potentially use such a product beyond CLIA-certified laboratories to include both laboratories and non-laboratories that have not complied with the quality control, training and other requirements under CLIA. The CLIA waiver related to our OraQuick ADVANCE® test has had a significant impact on the Company, and is fully discussed on page 4 of the 10-K Report. Sales of our OraQuick® test accounted for $35.3 million, or approximately 50% of our total revenues for 2008. As noted on page 4 of the 10-K Report, we received a CLIA waiver for the use of this test with oral fluid and fingerstick and venous whole blood. In the absence of a CLIA waiver, this test would be available for use by approximately 40,000 locations in the U.S. that are certified under CLIA to perform moderately complex tests. However, as a result of the receipt of a CLIA waiver, the test can also be used by approximately 140,000 additional sites in the U.S. not certified under CLIA to perform moderately complex tests. This would include non-laboratory customers such as outreach clinics, community-based organizations and physicians’ offices. We believe the discussion on pages 4 and 18 of the 10-K Report adequately describes the significance of the CLIA waiver obtained for our OraQuick ADVANCE® HIV test. Our Q.E.D. ® test accounted for $1.3 million, or only approximately 1.8%, of our total 2008 revenues. Although we believe the receipt of a CLIA waiver has also expanded the customer base that can potentially use this product, given the relatively small amount of revenue -2- [*Confidential Treatment Requested by OraSure Technologies, Inc.] generated by the Q.E.D.® product line, we do not believe further discussion of this issue is material or useful for investors. Subject to the clarification described above, we believe there is adequate disclosure in the 10-K Report regarding the significance of the CLIA waivers. Comment 3 (The Unavailability of Certain Products Distributed by a Third-Party, p. 26) Staff Comment: We note your disclosure that BMX sold the only oral fluid HIV-1 EIA screening test. In future filings, please revise to disclose more prominently that, in BMX’s absence, you will be forced to conduct clinical trial and seek FDA approval for an alternative test. In addition, please expand this risk factor to discuss more fully the risk that you may not receive FDA approval. Company Response: [*A01] Our future filings will describe this recent change in circumstances and indicate that the previously disclosed clinical trials will not be required. Comment 4 (Financial Statements - Note 8. Income Taxes, p. F-17) Staff Comment: We note that you recorded the valuation allowance of $25,978,167, which is equal to 100% of your deferred tax assets. You disclosed that “Given the uncertainty surrounding the magnitude and length of the current economic condition, [your] loss in 2008, and [your] projection of a loss in 2009, [you] determined that it is more likely than not [you] will not realize the benefits associated with [your] net deferred tax assets in the immediate future. We note approximately $17 Million out of your approximately $26 Million deferred tax assets is net operating loss carry forwards, net of tax effect. While we note your discussion about your valuation allowance in your Critical Accounting Estimates, it is still not clear to us how you determined that the entire balance of the deferred tax asset should have been reserved when approximately 88% out of your total federal net operating loss carry forwards will be expired on and beyond 2017. Please explain to us the basis of your analysis whereby you are projecting that it is more likely than not that you will not be able to utilize your net operating loss carry forward in 2017 and beyond. Please provide us with your analysis of available evidence, both positive and negative, that you considered in determining your need for a full valuation allowance at December 31, 2008. -3- [*Confidential Treatment Requested by OraSure Technologies, Inc.] Company Response: Supplementally, we advise the Staff of the following evidence which we considered when determining the need for a full valuation allowance in relation to our net deferred tax asset balance. We have followed the guidance provided by Paragraph 17(e) of Statement of Financial Accounting Standards (“SFAS”) 109, “Accounting for Income Taxes,” which calls for a reduction of deferred tax assets by a valuation allowance, if “... based on the weight of available evidence, it is more likely than not (a likelihood of more than 50 percent) that some portion of all of the deferred tax assets will not be realized.” We considered the following positive and negative evidence in reaching our conclusion that a full valuation allowance was necessary at December 31, 2008: Positive evidence: • The Company is a leader in the rapid oral fluid testing industry, which is a part of the growing medical diagnostics industry; • The Company has existing contracts with domestic and international distributors and customers that we believe will generate taxable book income in future years. At December 31, 2008, we believed the future cash flows to be received from revenues generated by our long-lived assets and intangible assets (property and equipment, and patents and product rights, respectively), would exceed their book value and as such, we did not recognize any impairment loss on the value of those assets for the year ended December 31, 2008; • The Company has several products in varying stages of development within its research and development product pipeline that could be a source of future revenues; • As a tax planning strategy, the Company could make an election under §59(e) of the U.S. Internal Revenue Code to capitalize certain research and development expenses, within the limitations prescribed therein, thereby extending the potential expiration of certain operating loss carryforwards which would expire within the next several years; and • Long carryforward periods are permitted under U.S. tax law for utilization of our federal and most state net operating loss carryforwards and tax credits. Negative evidence: • The Company has a history of pre-tax losses and an accumulated deficit of $127 million at December 31, 2008. Our Company was formed on September 29, 2000. Prior to formation, our predecessor companies also incurred significant pre-tax losses. Since our inception, our pre-tax income or (loss) for each year ended December 31, was as follows: 2000 $ (12,722,187 ) 2001 (3,399,000 ) 2002 (3,342,473 ) 2003 (1,108,947 ) -4- [*Confidential Treatment Requested by OraSure Technologies, Inc.] 2004 (559,642 ) 2005 9,718,898 2006 9,061,453 2007 4,293,775 2008 (8,747,968 ) • In the fourth quarter of 2008, the Company completed its budgeting process, which projected a pre-tax loss of approximately [*A02] for fiscal year 2009. In fiscal 2007, the Company recorded pre-tax income of $4.3 million, and in 2008, a pre-tax loss of $8.7 million, which included $4.9 million in other income from a litigation settlement in that same fiscal year. With the budgeted pre-tax loss expected in 2009, the Company would be in a cumulative three-year pre-tax loss position of approximately [*A03] as of December 31, 2009. As indicated in Paragraph 23 of SFAS 109, forming a conclusion that a valuation allowance is not needed is difficult when there is a significant piece of negative evidence to overcome, such as a cumulative loss in recent years. • The Company has not paid federal income taxes in the current or prior fiscal years, with the exception of alternative minimum taxes, and therefore, carryback of losses is not available. • Some of the primary drivers of future revenue growth for our Company are products that are in varying stages of development and that will be subject to regulation by the U.S. Food and Drug Administration (“FDA”) or other governmental or public health agencies. The process of obtaining FDA approval is inherently uncertain and can involve lengthy and detailed laboratory testing, human clinical trials, sampling activities, and other costly, time-consuming procedures. The approval process can by complex and lengthy. Failure to obtain or any delay in obtaining FDA approval for new products could significantly reduce our future revenues, increase our costs, and adversely affect our financial performance. As indicated, there is uncertainty surrounding the timing and cost of regulatory approvals, if obtained. As such, we cannot predict with any level of accuracy, the potential impact on future revenues or expenses associated with obtaining regulatory approval of new products. • The uncertainty surrounding the magnitude and length of the global recession makes predicting future results from current operations more difficult than in previous years. • At December 31, 2008, the Company did not have any significant sales backlog. • The reversal of existing temporary differences or deferred tax liabilities is not significant on an annual basis. • The Company is involved in patent infringement litigation, which alleges that the manufacture and sale of our primary rapid oral fluid HIV testing device infringes a patent held by another party. During fiscal 2008, sales of this product accounted for 49.6% of the Company’s $71 million in total revenues. In the event we are unable to successfully defend against the current litigation, or it is determined that a license to this patent is required and we cannot obtain such a license on reasonable terms, our ability to sell this device may be limited, which would adversely affect our results of operations, pre-tax income, cash flows, and our -5- [*Confidential Treatment Requested by OraSure Technologies, Inc.] overall business. As of December 31, 2008, we were unable to predict with any level of certainty the resolution of this unsettled circumstance and we expected to incur substantial legal expenses in 2009 as a result of this litigation. • In order to remain competitive, we must regularly commit substantial resources to research and development and the commercialization of new products. The research and development process can take a significant amount of time from inception to commercial product launch. During 2008, 2007, and 2006, we incurred $20.3 million, $14.1 million, and $8.6 million, respectively, in research and development expenses. We expect to continue to incur significant costs from our ongoing research and development activities, even though future products may not be commercialized or approved by the FDA. At December 31, 2008, we believed the negative evidence noted above far outweighed the positive evidence presented. Given the level of our pre-tax loss in 2008 and our expected pre-tax loss in 2009, we believed that we could be in a cumulative three-year pre-tax loss position even through [*A04]. Our ability to forecast future revenues and pre-tax earnings beyond 2009 is impacted by the uncertainties and unsettled circumstances described above, especially those associated with regulatory approval and clinical development expenses for our future products. We advise the Staff that this was recently proven to be true, as indicated by the June 25, 2009 Form 8-K we filed, stating that the FDA did not approve our application for approval of our rapid oral-fluid HCV test as originally submitted, but rather, is now requiring us to perform additional clinical studies in support of the test, which we believe could cost an additional [*A05]. At December 31, 2008, we did not believe that we could reliably forecast annual pre-tax earnings beyond 2009 to the level necessary to realize our deferred tax assets. As such, we did not believe that it was more likely than not that we could realize our deferred tax assets in the future, and accordingly, we recorded a full valuation allowance against our net deferred tax assets. Comment 5 (Financial Statements - Note 12. Other Income, p. F-23) Staff Comment: We see that you entered into a settlement and license agreement with Schering-Plough in January 2008 to resolve your patent infringement litigation and Schering paid you $4.9 million which you recorded as other income. In future filings please reclassify this income within operating income, or tell us in detail why you believe this income is properly classified in non-operating inc
2009-09-01 - UPLOAD - ORASURE TECHNOLOGIES INC
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
DIVISION OF
CORPORATION FINANCE
Mail Stop 3030
August 31, 2009
VIA U.S. MAIL AND FAX 610-882-2275
Ronald H. Spair Chief Financial Officer Orasure Technologies, Inc.
220 East First Street
Bethlehem, Pennsylvania 18015
Re: Orasure Technologies, Inc.
Form 10-K for the year ended December 31, 2008
Filed March 10, 2009 File No. 001-16537
Dear Mr. Spair:
We have reviewed your filing and have th e following comments. Where indicated, we
think you should revise your document in response to these comments. If you disagree, we will
consider your explanation as to why our commen t is inapplicable or a revision is unnecessary.
Please be as detailed as necessa ry in your explanation. In some of our comments, we may ask
you to provide us with information so we may better understand your disclosure. After
reviewing this information, we may raise additional comments.
Please understand that the purpose of our re view process is to assist you in your
compliance with the applicable disclosure requir ements and to enhance the overall disclosure in
your filing. We look forward to working with you in these respects. We welcome any questions
you may have about our comments or any other aspect of our review. Feel fr ee to call us at the
telephone numbers listed at the end of th is letter.
Ronald H. Spair
Orasure Technologies, Inc.
August 31, 2009 Page 2 Form 10-K for the year ended December 31, 2008
Supply and Manufacturing, page 12
1. It appears that upon te rmination of your agreement with BMX you purchased a two-year
supply of HIV antigen required to manufacture th e Western blot test. In your disclosure,
you indicate that your current supply will be suffi cient for at least the next several years.
Please confirm that you will provide in future fi lings a more specific estimate as to when
you will exhaust your reserves. Alternatively, please tell us why you believe that this
information is not material. For instance, if you have made or anticipate being able to make alternative arrangements, please clearly disclose in future filings.
Domestic Regulations, page 17
2. Refer to the penultimate paragraph of this se ction. With a view toward disclosure in
future filings, please explain more fully the significance of the waivers you have acquired. Do the waivers apply to your laborat ories or those of your customers or both?
Are the waivers subject to cer tain restrictions? Can th ey expire? Please clarify.
The Unavailability of Certain Products Distributed by a Third-Party…, page 26
3. We note your disclosure that BMX sold the only oral fluid HIV-1 EIA screening test. In
future filings, please revise to disclose more prominently that, in BMX’s absence, you will be forced to conduct clinical trial and s eek FDA approval for an alternative test. In
addition, please expand this risk factor to discuss more fully the risk that you may not
receive FDA approval.
Financial Statements, page F-1
Note 8. Income Taxes, page F-17
4. We note that you recorded the valuation allowance of $25,978,167, which is equal to
100% of your deferred tax assets. You disclo sed that “Given the uncertainty surrounding
the magnitude and length of the curren t economic condition, [your] loss in 2008, and
[your] projection of a loss in 2009, [you] determined that it is more likely than not [you]
will not realize the benefits associated w ith [your] net deferred tax assets in the
immediate future. We note approximately $17 Million out of your approximately $26 Million deferred tax assets is net operating loss carry forwards, net of tax effect.
While we note your discussion about your valuation allowance in your Critical
Accounting Estimates, it is stil l not clear to us how you determined that the entire balance
of the deferred tax asset should have been reserved when approximately 88% out of your total federal net operating loss ca rry forwards will be expired on and beyond 2017.
Please explain to us the basis of your analys is whereby you are projecting that it is more
Ronald H. Spair
Orasure Technologies, Inc.
August 31, 2009 Page 3
likely than not that you will not be able to u tilize your net operating loss carry forward in
2017 and beyond. Please provide us with your analysis of available evidence, both positive and negative, that you considered in determining your need for a full valuation
allowance at December 31, 2008.
Note 12. Other Income, page F-23
5. We see that you entered into a settlement a nd license agreement with Schering-Plough in
January 2008 to resolve your patent infri ngement litigation and Schering paid you $4.9
million which you recorded as other income. In future filings please reclassify this
income within operating income, or tell us in detail why you believe this income is
properly classified in no n-operating income. Your e xplanation should include a
discussion of why the license agreement and the underlying patent do not relate to your
operating activities.
Exhibits
6. We note your disclosure on pages 12 and 25 that you have long-term contracts with
single source suppliers to provi de the antigen and nitrocellulose used in your OraQuick
line and that it would require significant time to replace these vendors. Given the
importance of OraQuick sales to your business operations, pl ease file these contracts as
exhibits, or provide us with a detailed legal analysis expl aining your basis for not filing
them. Refer to Item 601(b)(10) of Regulation S-K.
7. We also note your disclosure on page 47 that you have entered a collaboration agreement
with Schering-Plough to develop and promote a rapid oral flui d test for the detection of
HCV antibodies. Please file this contract as an exhibit, or provide us with a detailed legal
analysis explaining your basis for not filing it. Refer to Item 601(b)(10) of Regulation S-
K.
As appropriate, please respond to these comments within 10 business days or tell us when
you will provide us with a response. Detailed cove r letters greatly facilita te our review. Please
understand that we may have additional comm ents after reviewing your amendment and
responses to our comments.
We urge all persons who are responsible for th e accuracy and adequacy of the disclosure
in the filing to be certain that the filing includes all information re quired under the Securities
Exchange Act of 1934 and that they have provi ded all information investors require for an
informed investment decision. Since the compa ny and its management are in possession of all
facts relating to a company’s disclosure, they are responsible for the acc uracy and adequacy of
the disclosures they have made.
Ronald H. Spair
Orasure Technologies, Inc. August 31, 2009 Page 4
In connection with responding to our comment s, please provide, in writing, a statement
from the company acknowledging that:
the company is responsible for the adequacy and accuracy of the disclo sure in the filing;
staff comments or changes to disclosure in response to staff comments do not foreclose
the Commission from taking any action with respect to the filing; and
the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federa l securities laws of the United States.
In addition, please be advise d that the Division of Enfo rcement has access to all
information you provide to the sta ff of the Division of Corporati on Finance in our review of your
filing or in response to our comments on your filing.
You may contact Andri Boerman at (202) 551-3645 or me at (202) 551-3640 if you have
questions regarding comments on th e financial statements and rela ted matters. Please contact
Joe McCann at (202) 551-6262 or Dan Morris at (202) 551-3314 if you have questions on other comments.
S i n c e r e l y ,
J u l i e S h e r m a n Reviewing Accountant
2005-06-10 - CORRESP - ORASURE TECHNOLOGIES INC
CORRESP 1 filename1.htm Correspondence Letter [*Confidential Treatment Request by OraSure Technologies, Inc.] June 10, 2005 Transmitted Via EDGAR and Facsimile Ms. Kate Tillan Assistant Chief Accountant Securities and Exchange Commission Division of Corporation Finance 450 Fifth Street, N.W. Washington, D.C. 20549 Re: OraSure Technologies, Inc. Form 10-K for the Year Ended December 31, 2004 (“10-K Report”) SEC File No. 1-16537 Dear Ms. Tillan: In response to your letter dated May 18, 2005 (the “Comment Letter”) with respect to the above-referenced 10-K Report and in order to clarify our response letter dated April 22, 2005, (the “April 22 Response”), OraSure Technologies, Inc. (the “Company”) is providing the following explanations and supplemental information in response to the Staff’s additional comments. The responses set forth below are labeled to correspond to the numbers assigned by the Staff to its comments in the Comment Letter. Comment 1 In response to this comment, the Company’s future filings will indicate, if true, that our officers concluded that the disclosure controls and procedures are effective to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is accumulated and communicated to the Company’s management, including the chief executive officer and chief financial officer, to allow timely decisions regarding required disclosure. Comment 2 (a) As indicated in the April 22 Response, the Company does not recognize any separate revenue related solely to the analytical instrument (“equipment”) provided to and used by a limited number of our customers, under certain “reagent rental” agreements which we have executed with them. We believe the utilization of this equipment by our customers is dependent upon the specific immunoassay tests and reagents purchased by them. Furthermore, these same immunoassay tests or reagents cannot be utilized without the equipment. As such, we believe [*Confidential Treatment Request by OraSure Technologies, Inc.] that the customers do not have full use of the equipment without the requisite tests and reagents. Pursuant to these reagent rental agreements, our customers have a contractual obligation to purchase a minimum number of immunoassay tests and reagents on an annual basis, based upon their utilization patterns. As such, the customer controls the timing of delivery of these immunoassay tests and reagents during each annual period. Also, the total consideration associated with this arrangement is not fixed or determinable, as it is ultimately contingent upon the customer’s utilization rates. Immunoassay tests and reagents are generally not returnable by our customers, except for normal warranty returns. Accordingly, the Company recognizes revenue when the non-returnable immunoassay tests and reagents are shipped to these customers. We believe that all revenue is earned and obligations are fulfilled in tandem with the shipment of these immunoassay tests and reagents since it is only at this point that the customer can and will utilize the related equipment. Pursuant to these reagent rental agreements, our customers generally purchase immunoassay tests and reagents throughout the term of their respective agreement, on a relatively consistent basis, from quarter to quarter. As such, we believe that bifurcation of a reagent rental agreement into distinct leasing and supply components would not render results that are materially different, on a quarter-to-quarter basis, than our current accounting treatment. Our conclusion is based upon the following fact pattern, demonstrated for an average reagent rental customer during 2004: 1. Total revenues generated via the average reagent rental customer in 2004: $[ *A01 ] 2. Fair Market Value of the annual minimum number of tests included in contract: $[ *A02 ] 3. Fair Market Value of the annual lease payment for this equipment, based upon independent third-party leasing information obtained by the Company: $[ *A03 ] 4. Total Fair Market Value of the contract ($[ *A04 ]) $[ *A05 ] 5. Percentage allocable to equipment ($[ *A06 ]): [*A07]% Month Average Revenue Recognized (a) Amount allocable to equipment (b) (Column (a) * [*A08]%) Straight-line Recognition of amount allocable to equipment (c) ($[ *A09 ]) Difference (d) Column (b) – Column (c) Quarter 1 $ [*A10] $ [*A11] $ [*A12] [*A13] Quarter 2 $ [*A14] $ [*A15] $ [*A16] [*A17] Quarter 3 $ [*A18] $ [*A19] $ [*A20] $ [*A21] Quarter 4 $ [*A22] $ [*A23] $ [*A24] $ [*A25] Total $ [*A26] $ [*A27] $ [*A28] $ [*A29] -2- [*Confidential Treatment Request by OraSure Technologies, Inc.] As demonstrated in the example above, bifurcating reagent rental agreements into distinct leasing and supply components would vary our quarterly revenues by a maximum of $[*A30] per quarter per customer. We therefore believe that bifurcation of a reagent rental agreement would not render results that are materially different, on a quarter-to-quarter basis, than our current accounting treatment. During the years ended December 31, 2004, 2003, and 2002, we had reagent rental agreements with [ *A31 ] customers, respectively. The total revenues generated from these reagent rental agreements for the years ended December 31, 2004, 2003, and 2002, were $[ *A32 ], or [ *A33 ]% of product revenues, respectively. Gross margin recognized from these revenues was approximately $[ *A34 ], or [ *A35 ]% of total gross margin realized in the years ended December 31, 2004, 2003, and 2002, respectively. As this demonstrates, total revenues and gross margin generated by these agreements, are immaterial to the Company’s results of operations and financial position. In consideration of the foregoing, we believe that our recognition of revenue upon shipment of immunoassay tests and reagents to our customers, over the contractual term of our reagent rental agreements, during which mutual obligations are fulfilled and the benefits derived from the equipment are diminished, is appropriate. (b) Supplementally, we wish to clarify the April 22 Response to the Staff. We agree that we are providing three separate elements: (1) prepackaged test kits, (2) laboratory testing services, and (3) shipping. While not specifically addressed in the April 22 Response, shipping is a separate element of the Company’s OraSure® HIV-1 testing kits and we do treat it as such. Shipping fees are related to the overnight shipment of specimens to the laboratory, for testing within 24 hours of receipt. Our response did not address shipping revenues separately because we recognize them in tandem with recognizing revenue from laboratory testing services (i.e., shipping fees are deferred until we receive information from the laboratories indicating the specimen was received). We commonly refer to “testing services” as inclusive of the shipping fee and laboratory testing service. While our accounting treatment for both elements is similar, our response should have addressed these items separately. We apologize for any confusion this may have caused the Staff. Upon shipment of an OraSure® HIV-1 testing kit to our customer, revenues associated with shipping the specimen to the laboratory and the subsequent laboratory testing services are both deferred, since neither the specimen shipment nor the laboratory testing services have been rendered at that point in time. Revenues from shipping and laboratory testing services are then recognized upon receipt of information from the laboratories indicating that the specimens have been received and the testing services have been performed. -3- [*Confidential Treatment Request by OraSure Technologies, Inc.] In reference to the statement in the April 22 Response regarding recognition of revenue for testing services over a four-to-six month period, we wish to clarify that four-to-six months is the average period of time over which the customer utilizes the OraSure® HIV-1 kits (i.e. the period of time over which the shipping and laboratory testing services are performed). As stated in the April 22 Response, the four-to-six month period was determined based on information provided to us by the laboratories in their invoices for the related services. During this timeframe, since services are performed, we recognize the related revenue. For the reasons set forth above, we believe our accounting treatment of revenue received from the sale of OraSure® HIV-1 testing kits is appropriate. In connection with the foregoing responses, the Company acknowledges that (i) the Company is responsible for the adequacy and accuracy of the disclosure in its filings; (ii) Staff comments or changes to disclosure in response to Staff comments in the filings reviewed by the Staff do not foreclose the Commission from taking any action with respect to the filing; and (iii) the Company may not assert Staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please do not hesitate to contact the undersigned (610-882-1820, ext. 3279) if you have any questions or if we can provide any further information that would be helpful to the Staff. Sincerely, /s/ Ronald Spair Ronald Spair Executive Vice President and Chief Financial Officer cc: D. Michels, President and Chief Executive Officer J. Jerrett, Senior Vice President and General Counsel M. Kuna, Vice President and Controller E. Stortz, Financial Reporting Specialist F. Hausmann, Chairman, Audit Committee J. Gerard, KPMG LLP E. DeTrizio, Dechert LLP -4-
2005-05-19 - UPLOAD - ORASURE TECHNOLOGIES INC
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
Mail Stop 0306
May 18, 2005
Via Facsimile and U.S. Mail
Mr. Ronald H. Spair
Chief Financial Officer
Orasure Technologies, Inc.
220 East First Street
Bethlehem, PA 18015
Re: Orasure Technologies, Inc.
Form 10-K for the year ended December 31, 2004
SEC File No. 1-16537
Dear Mr. Spair:
We have reviewed your response letter dated April 22, 2005
and
have the following additional comments. We have limited our
review
to those issues we have addressed in our comments. Where
indicated,
we think you should revise your future filings in response to
these
comments. If you disagree, we will consider your explanation as
to
why our comments are inapplicable or a revision is unnecessary.
Please be as detailed as necessary in your explanation. In some
of
our comments, we may ask you to provide us with supplemental
information so we may better understand your disclosure. After
reviewing this information, we may or may not raise additional
comments.
Please understand that the purpose of our review process is
to
assist you in your compliance with the applicable disclosure
requirements and to enhance the overall disclosure in your filing.
We look forward to working with you in these respects. We welcome
any questions you may have about our comments or on any other
aspect
of our review. Feel free to call us at the telephone numbers
listed
at the end of this letter.
Form 10-K for the Fiscal Year Ended December 31, 2004
Item9A. Controls and Procedures - Page 51
1. See prior comment 1. We note your response. If you wish to
include
the definition following your conclusion, please ensure the
definition is consistent with the definition included in Rule 13a-
15(e) of the Exchange Act. That is, revise future filings to also
clarify, if true, that your officers concluded that your
disclosure
controls and procedures are effective to ensure that information
required to be disclosed in the reports that you file or submit
under
the Exchange Act is accumulated and communicated to your
management,
including your chief executive officer and chief financial
officer,
to allow timely decisions regarding required disclosure.
Financial Statements - Page F-1
Note 2. Summary of Significant Accounting Policies - Page F-7
Revenue Recognition - Page F-9
2. See prior comment 3.
a. See prior comment 3(B). It appears that your agreements include
a
lease arrangement with respect to the equipment for which you are
not
providing separate accounting. If material, please revise
historical
and future filings to properly account for these transactions, or
tell us why the current accounting is appropriate.
b. See prior comment 3(C). It appears that you are providing three
separate elements: (1) prepackaged test kits, (2) laboratory
testing
services, and (3) shipping. If material, please revise historical
and
future filings to properly account for each element, or tell us
why
the current accounting is appropriate. In addition, please explain
why you refer to recording revenue for testing services over a
four-
to-six month period and not as the services are performed.
* * * *
As appropriate, please respond to these comments within 10
business days or tell us when you will provide us with a response.
Please furnish a cover letter that keys your response to our
comments
and provides any requested supplemental information. Detailed
cover
letters greatly facilitate our review. Please file your cover
letter
on EDGAR. Please understand that we may have additional comments
after reviewing your response to our comment.
You may contact Heather Tress, Staff Accountant, at (202)
551-
3624 or me at (202) 551-3604 if you have questions regarding
comments
on the financial statements and related matters. In this regard,
do
not hesitate to contact Michele Gohlke, Accounting Branch Chief,
at
(202) 551-3327.
Sincerely,
Kate Tillan
Assistant Chief Accountant
??
??
??
??
Mr. Ronald H. Spair
Orasure Technologies, Inc.
May 18, 2005
Page 1 of 3
</TEXT>
</DOCUMENT>
2005-04-22 - CORRESP - ORASURE TECHNOLOGIES INC
CORRESP 1 filename1.htm Correspondence [*Confidential Treatment Requested by OraSure Technologies, Inc.] April 22, 2005 Transmitted Via EDGAR and Facsimile Ms. Kate Tillan Assistant Chief Accountant Securities and Exchange Commission Division of Corporation Finance 450 Fifth Street, N.W. Washington, D.C. 20549 Re: OraSure Technologies, Inc. Form 10-K for the Year Ended December 31, 2004 (“10-K Report”) SEC File No. 1-16537 Dear Ms. Tillan: In response to your letter dated April 8, 2005 (the “Comment Letter”) with respect to the above-referenced 10-K Report, OraSure Technologies, Inc. (“OraSure” or the “Company”) is providing the following responses and supplemental information in response to the Staff’s comments. The responses set forth below are labeled to correspond to the numbers assigned by the Staff to its comments. Comment 1 In response to this Comment, the Company’s future filings will be revised to indicate the conclusions reached by the Company’s Chief Executive Officer and Chief Financial Officer in evaluating whether the Company’s disclosure controls and procedures are effective in ensuring that information required to be disclosed by the Company in its reports is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the Securities and Exchange Commission (the “Commission”). This disclosure will thus incorporate the definition of “disclosure controls and procedures” set forth in Exchange Act Rule 13a-15(e). Comment 2 Item 308(c) of Regulation S-K requires the disclosure of any change in the Company’s internal control over financial reporting “identified in connection” with the evaluation required by Exchange Act Rule 13a-15(c) or 15d-15(c) that occurred during the Company’s last fiscal quarter (or fourth quarter in the case of the annual report) that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting. The Company’s future filings will be revised to indicate whether there was any change “identified in connection” with each such evaluation performed by the Company. [*Confidential Treatment Requested by OraSure Technologies, Inc.] Comment 3 The following are responses to Comments regarding the Company’s revenue recognition policies: (A) Supplementally, we advise the Staff that the Company maintains contractual agreements pursuant to which certain distributors are entitled to receive annual volume rebates. Rebates are based upon each distributor’s targeted sales of our products. Historically, these distributors have met or exceeded the targets included in their respective agreements. As such, in accordance with Emerging Issues Task Force (“EITF”) Issue No. 01-09, Accounting for Consideration Given by a Vendor to a Customer (Including a Reseller of the Vendor’s Product), we account for these rebates in our financial statements as a direct reduction of the underlying monthly revenues derived from these distributors. Rebates are accrued monthly and paid to these distributors, in arrears. For the years ended December 31, 2004, 2003 and 2002, we reduced our product revenues by approximately [ *A01 ,] respectively, for these rebates. These rebates represent [ *A02 ] of total product revenues for the years ended December 31, 2004, 2003 and 2002, respectively. As requested by this Comment, the Company will provide, in future filings, further disclosure on the nature, terms and related accounting treatment of rebates recognized in each period presented, to the extent they are material. (B) Supplementally, we would like to advise the Staff of the nature of the Company’s “reagent rental” agreements, which we have executed with a limited number of customers. As disclosed in the Company’s filings, we develop and sell a variety of immunoassay tests and reagents, in formats tailored to meet the specific needs of our customers. Our immunoassay tests and reagents are sold to national testing firms, as well as smaller local laboratories. These laboratory tests are performed exclusively on automated analytical instruments. The term “reagent rental” is specific to our industry and is used to describe a contract under which a new customer purchases tests or reagents from us at an agreed-upon price, usually over a multi-year period. These customers, however, desire to perform testing via an automated analytical instrument, but they do not have one in-house. Pursuant to a “reagent rental” agreement, in exchange for an increased price per test and a commitment by the customer to purchase a minimum number of tests, the Company supplies the customer with a small piece of analytical equipment for use in processing. In essence, the customer pays a higher price for immunoassay tests or reagents than it would if it had its own equipment. The Company monitors the purchases made by customers who have executed these agreements. Generally, these customers meet their minimum purchase requirements. Because utilization of an instrument by our customer is dependent upon the specific immunoassay tests and reagents purchased by them, and these same immunoassay tests cannot be performed without the instrument, the Company recognizes revenue when we ship non-returnable immunoassay tests and reagents to these customers. The Company does not recognize any separate revenue related solely to the analytical instrument provided to and used by our customer. Prior to entering into a reagent rental agreement with a customer, the Company purchases the equipment from a third-party vendor. The average cost of this equipment is approximately $[ *A03 ]. The Company retains title to the equipment and the customer is required to return it to -2- [*Confidential Treatment Requested by OraSure Technologies, Inc.] us at the end of the contract period. The cost of the equipment is capitalized in the Company’s financial statements and amortized on a straight-line basis over five years, with the resulting depreciation expense recorded in cost of goods sold in our statement of operations. Related maintenance costs are expensed as incurred. As supplemental information, revenues related to the sale of immunoassay tests or reagents under these agreements were approximately $[ *A04 ], or [ *A05 ]% of product revenues for the years ended December 31, 2004, 2003 and 2002, respectively. It is anticipated that revenues from these agreements will continue to decline in the future, as the Company does not actively pursue this type of business. Gross margin recognized from these revenues was approximately $[ *A06 ] or [ *A07 ]% of total gross margin realized in the years ended December 31, 2004, 2003 and 2002, respectively. As requested by this Comment, we will disclose, in future filings, the nature, significant terms and related accounting treatment for these agreements, if material. (C) Supplementally, we would like to advise the Staff of the nature, timing and measurement of revenues related to the sale of our OraSure® HIV-1 testing kits, as well as the terms of the contractual agreements that we have with two national laboratories. As indicated in our 10-K Report, the Company sells a prepackaged OraSure® HIV-1 testing kit, comprised of an oral fluid collection device coupled with prepaid laboratory testing and shipping services. These kits are marketed to various community-based clinics, agencies, and state and local public-health organizations. These organizations generally do not have a third-party laboratory relationship or the ability to perform laboratory testing in-house. The Company, however, has negotiated laboratory testing service agreements with two national laboratories, LabOne, Inc. and Heritage Labs International, LLC, pursuant to which these laboratories have agreed to provide HIV-1 testing services on oral fluid samples submitted by our kit customers. Accordingly, our kit customers collect an oral fluid sample from their clients, and then forward the sample to one of these prescribed laboratories for testing and confirmation. The laboratory invoices the Company for the testing services, at the contracted price, once the services have been rendered. The Company concurs with the Staff in the treatment of these kit sales as revenue arrangements with multiple-deliverables. The Company accounts for revenues derived from OraSure® testing kits in accordance with the authoritative guidance included in Staff Accounting Bulletin No. 104, Revenue Recognition in Financial Statements, and EITF Issue No. 00-21, Revenue Arrangements with Multiple Deliverables. Revenues derived from OraSure® testing kits are divided into two separate units of accounting, the non-returnable OraSure® oral-fluid collection device and the laboratory testing services. The OraSure® collection device has stand-alone value to our customer, as it can be used readily with any laboratory and it can be sold commercially on a stand-alone basis. Likewise, HIV testing services are commercially available from a wide variety of laboratories. As such, we believe there is objective, reliable and verifiable evidence of the fair value for the collection device and testing service. In addition, there are no rights of return associated with our testing kits, other than for warranty issues. Accordingly, revenues are allocated based upon the relative fair values of the device and testing services. Revenue associated with the non-returnable oral fluid collection device is recognized upon shipment of the kit to our customer. Revenue associated with the testing service, however, is deferred, since the testing service has not yet been rendered. Generally, we recognize this deferred revenue over a four-to-six month period, when the designated laboratories render the testing service. Recognition is based upon information provided to us by the laboratories and receipt of their invoices for the related testing services. -3- [*Confidential Treatment Requested by OraSure Technologies, Inc.] The Company’s revenue recognition policy as it relates to these testing kits has been consistently applied in all periods presented in our 10-K Report. As supplemental information, net revenues derived from sales of OraSure® HIV-1 testing kits were approximately $[ *A08 ] or [ *A09 ]% of product revenues for the years ended December 31, 2004, 2003 and 2002, respectively. Gross margin recognized from these revenues was approximately $[ *A10 ] or [ *A11 ]% of total gross margin realized in the years ended December 31, 2004, 2003 and 2002, respectively. In October 2004, the Company commercially launched a new product, the OraQuick® ADVANCE HIV-1/2 test. As previously disclosed in Management’s Discussion and Analysis of Financial Condition and Results of Operations for the twelve months ended December 31, 2004 compared to December 31, 2003, in our 10-K Report, sales of the OraSure® HIV-1 testing kits are expected to decline, as customers switch to the new OraQuick® ADVANCE HIV-1/2 test. As requested by this Comment, we will disclose, in future filings, the nature, significant terms, and related accounting treatment for these agreements, if material. (D) Supplementally, we would like to advise the Staff of the terms and conditions related to our sales of laboratory testing equipment, often referred to in our industry as automated analytical instruments, as well as the manner in which the Company accounts for these revenues. As noted in this Comment, the Company purchases equipment from third-party vendors, for resale to a limited number of our customers. Based upon the customer’s specifications, we also license, from an outside vendor, an operating software program required to facilitate the customer’s testing protocol on the related analytical instrument. Our technicians install the software into the instrument and then test the instrument’s functionality to ensure that it will operate in the same manner in the customer’s environment as it does in our facility. We then sell the complete unit to our customer as a turnkey solution to their testing needs. The Company accounts for revenue derived from equipment sales in accordance with EITF Issue No. 99-19, Reporting Revenue Gross as a Principal versus Net as an Agent. We record equipment revenues on a gross basis, given we act as a principal in the transaction with our customer, we take title to the equipment upon our purchase of it, we install software and test the equipment’s functionality, and we bear the risks of ownership associated with the equipment until it is sold to the customer. When we initially purchase the equipment and software for resale, we capitalize it as inventory. When we ship the completed instrument to our customer, we simultaneously recognize this equipment sale as product revenues, and the related costs of the equipment and software, as cost of goods sold, in our statement of operations. The average selling price of a completed unit is approximately $[ *A12 ]. Our contract with our customer does not contain any customer specific acceptance provisions, we do not offer any type of extended warranties or rights of return and we do not have any ongoing obligation to install or service the equipment. Should a customer wish to lease a piece of equipment, we offer to introduce them to leasing organizations familiar with this type of equipment, however, the customer must secure its own financing independent of the Company. The Company does not lease equipment to customers. We deem equipment sales to be an insignificant part of our business and as such, we do not actively pursue additional business in this segment of the diagnostics market. As supplemental information, revenues recognized from equipment sales -4- [*Confidential Treatment Requested by OraSure Technologies, Inc.] were approximately $[ *A13 ] or [ *A14 ]% of product revenues for the years ended December 31, 2004, 2003 and 2002, respectively. Gross margin recognized from these revenues was approximately $[ *A15 ] or [ *A16 ]% of total gross margin realized in the years ended December 31, 2004, 2003 and 2002, respectively. As requested by this Comment, we will disclose, in future filings, the nature, significant terms, and related accounting treatment for these agreements, if material. In connection with the foregoing responses, the Company acknowledges that (i) the Company is responsible for the adequacy and accuracy of the disclosure in its filings; (ii) Staff comments or changes to disclosure in response to Staff comments in the filings reviewed by the Staff do not foreclose the Commission from taking any action with respect to the filing; and (iii) the Company may not assert Staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please do not hesitate to contact the undersigned (610-882-1820, ext. 3279) if you have any questions or if we can provide any further information that would be helpful to the Staff. Sincerely, /s/ Ronald H. Spair Ronald H. Spair Executive Vice President and Chief Financial Officer cc: D. Michels, President and Chief Executive Officer J. Jerrett, Senior Vice President and General Counsel M. Kuna, Vice President and Controller E. Stortz, Financial Reporting Specialist F. Hausmann, Chairman, Audit Committee J. Gerard, KPMG LLP E. DeTrizio, Dechert LLP -5-
2005-04-08 - UPLOAD - ORASURE TECHNOLOGIES INC
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<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
Mail Stop 0306
April 8, 2005
Via Facsimile and U.S. Mail
Mr. Ronald H. Spair
Chief Financial Officer
Orasure Technologies, Inc.
220 East First Street
Bethlehem, PA 18015
Re: Orasure Technologies, Inc.
Form 10-K for the year ended December 31, 2004
SEC File No. 1-16537
Dear Mr. Spair:
We have reviewed your filings and have the following
comments.
We have limited our review to those issues we have addressed in
our
comments. Where indicated, we think you should revise your future
filings in response to these comments. If you disagree, we will
consider your explanation as to why our comments are inapplicable
or
a revision is unnecessary. Please be as detailed as necessary in
your explanation. In some of our comments, we may ask you to
provide
us with supplemental information so we may better understand your
disclosure. After reviewing this information, we may or may not
raise additional comments.
Please understand that the purpose of our review process is
to
assist you in your compliance with the applicable disclosure
requirements and to enhance the overall disclosure in your filing.
We look forward to working with you in these respects. We welcome
any questions you may have about our comments or on any other
aspect
of our review. Feel free to call us at the telephone numbers
listed
at the end of this letter.
Form 10-K for the Fiscal Year Ended December 31, 2004
Item 9A. Controls and Procedures - Page 51
1. We note your statement that the chief executive officer and
company comptroller have concluded that the company`s disclosure
controls and procedures are "effective in timely alerting them to
material information relating to the Company that is required to
be
included in its periodic filings with the Securities and Exchange
Commission." It does not appear that your certifying officers have
reached a conclusion that your disclosure controls and procedures
are
effective. Please revise future filings to address your officers`
conclusions regarding the effectiveness of your disclosure
controls
and procedures. In addition, please note that the definition of
disclosure controls and procedures is included in Rule 13a-15(e)
of
the Exchange Act. However, if you wish to include the definition
in
your conclusion, please ensure the definition is consistent with
the
definition included in Rule 13a-15(e) of the Exchange Act.
2. Please revise the language in future filings used in your
disclosure concerning changes in your internal control over
financial
reporting to indicate whether there was any change, not only those
that "were identified as having occurred," to your internal
control
over financial reporting that has materially affected, or that is
reasonably likely to materially affect, your internal control over
financial reporting, consistent with the language used in amended
Item 308(c) of Regulation S-K.
Financial Statements - Page F-1
Note 2. Summary of Significant Accounting Policies - Page F-7
Revenue Recognition - Page F-9
3. Please respond to the following comments with respect to your
revenue recognition policies:
(A) We note that you provide rebates to your customers. Please
tell
us and disclose in future filings, if material, the nature and
terms
of your rebates and how you account for them. Supplementally
provide
us with the amount of rebates recognized in each period presented
and
the basis for your accounting method.
(B) We note from page 6 that you enter into multi-year sales
agreements with your customers. These agreements include a
minimum
number of tests that must be purchased over a two-to-five-year
period. The agreements may also include the option of a reagent
rental agreement under which you sell the tests at an increased
price
over a fixed period of time, which includes an additional
equipment
charge for providing the customer with the required laboratory
equipment. You obtain the equipment from a third-party vendor.
Please
tell us and disclose in future filings, if material, the nature
and
significant terms of these agreements and how you account for
them.
Supplementally provide us with the amount of revenues recognized
under these agreements in each period presented and the basis for
your accounting method.
(C) We note from the disclosure on page 10 that you also market
your
kits with laboratory testing services. As a result, you entered
into
agreements with laboratories to provide prepackaged test kits with
prepaid laboratory testing and specimen shipping costs included.
Please tell us and disclose in future filings, if material, the
nature and significant terms of these agreements and how you
account
for the related revenues. Supplementally provide us with the
amount
of revenues recognized under these agreements in each period
presented and the basis for your accounting method. Your response
should address how you consider each of the separate elements of
these arrangements in your revenue recognition policies. Include a
discussion of the timing and measurement of the related revenue.
(D) We note from the disclosure on pages 11 and 15 that you also
sell
third-party software and equipment. Please tell us and disclose in
future filings, if material, the nature and significant terms of
these sales and how you account for the related revenues.
Supplementally provide us with the amount of revenues recognized
for
sales of third-party equipment and software in each period
presented
and the basis for your accounting method. Address the accounting
for
both sales and rentals of the equipment.
* * * *
As appropriate, please respond to this comment within 10
business days or tell us when you will provide us with a response.
Please furnish a cover letter that keys your response to our
comments
and provides any requested supplemental information. Detailed
cover
letters greatly facilitate our review. Please file your cover
letter
on EDGAR. Please understand that we may have additional comments
after reviewing your response to our comment.
We urge all persons who are responsible for the accuracy and
adequacy of the disclosure in the filings reviewed by the staff to
be
certain that they have provided all information investors require.
Since the company and its management are in possession of all
facts
relating to a company`s disclosure, they are responsible for the
accuracy and adequacy of the disclosures they have made.
In connection with responding to our comments, please
provide,
in writing, a statement from the company acknowledging that:
* the company is responsible for the adequacy and accuracy of the
disclosure in the filings;
* staff comments or changes to disclosure in response to staff
comments in the filings reviewed by the staff do not foreclose the
Commission from taking any action with respect to the filing; and
* the company may not assert staff comments as a defense in any
proceeding initiated by the Commission or any person under the
federal securities laws of the United States.
In addition, please be advised that the Division of
Enforcement
has access to all information you provide to the staff of the
Division of Corporation Finance in our review of your filing or in
response to our comments on your filing.
You may contact Heather Tress, Staff Accountant, at (202)
824-
5263 or me at (202) 942-2861 if you have questions regarding
comments
on the financial statements and related matters. In this regard,
do
not hesitate to contact Martin James, the Senior Assistant Chief
Accountant, at (202) 942-1984.
Sincerely,
Kate Tillan
Assistant Chief Accountant
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Mr. Ronald H. Spair
Orasure Technologies, Inc.
April 8, 2005
Page 1 of 4
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