SEC Comment Letter for ORASURE TECHNOLOGIES INC (OSUR) (CIK 0001116463) (OSUR) — Sep 1, 2009
ORASURE TECHNOLOGIES INC (OSUR) (CIK 0001116463)
Date: Sept. 1, 2009 · CIK: 0001116463 · Accession: 0000000000-09-047916
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File numbers found in text: 001-16537
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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