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SEC Comment Letter for Axogen, Inc. (AXGN) (CIK 0000805928) (AXGN) — Apr 27, 2020

Axogen, Inc. (AXGN) (CIK 0000805928)
Date: April 27, 2020 · CIK: 0000805928 · Accession: 0000000000-20-003598

AI Filing Summary & Sentiment

File numbers found in text: 001-36046

Date
April 27, 2020
Author
Not clearly detected
Form
UPLOAD
Company
Axogen, Inc. (AXGN) (CIK 0000805928)

Letter

United States securities and exchange commission logo April 27, 2020 Peter Mariani Chief Financial Officer Axogen, Inc. 13631 Progress Boulevard, Suite 400 Alachua, FL 32615 Re:Axogen, Inc. Form 10-K For the Fiscal Year Ended December 31, 2019 Filed February 24, 2020 File No. 001-36046 Dear Mr. Mariani: We have limited our review of your filing to the financial statements and related disclosures 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 business days by providing the requested information or advise 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, 2019 Item 7. Management's Discussion and Analysis Comparison of the Years Ended December 31, 2019 and 2018, page 71 1.Please expand your results of operations discussion in future filings to quantify the impact of each factor identified, including offsetting, as causing changes in results between periods. For example, we note that your changes in revenue are attributable to a number of factors, including increases in unit volume, net impacts of price increases and changes in product mix. Please quantify the impact of each factor attributing to the increase, here, and throughout your discussion, in accordance with Item 303(a)(3)(iii) of Regulation S-K and Section III.D of SEC Release No. 33-6835. 2.We note the increase in your research and development expenses and that you have multiple products in varying stages of development and clinical testing. Please revise future filings to provide more detail for your research and development expenses for each

FirstName LastNamePeter Mariani Comapany NameAxogen, Inc. April 27, 2020 Page 2 FirstName LastNamePeter Mariani Axogen, Inc. April 27, 2020 Page 2 period presented, including but not limited to by product candidate as well as by the nature of the expenses. To the extent that you do not track expenses by product candidate, please disclose as such. Note 3. Summary of Significant Accounting Policies Revenue Recognition, page 91 3.We note your disclosure that you do not provide disaggregated revenue because of the similarity of products and arrangements. Please explain to us in greater detail your consideration of ASC 606-10-50-5 and 55-89 through 55-91 in determining that disaggregation of revenue is not required. In particular, describe what types of sales information is reviewed by management to assess operating performance and the similarity of your individual product gross margins impacting cash flows. As an example, we note that you cite changes in product mix as a factor in increasing revenue for the year. We also note in your recent earnings call that you identified Avance contributes over half your revenue and growth and you also describe differences between the direct and indirect sales channels. Lastly, tell us how you considered the disclosure requirements of ASC 280-10-50-40. Item 9A. Controls and Procedures, page 114 4.We note that within Management’s Annual Report on Internal Control Over Financial Reporting, you state that management evaluated the effectiveness of the design and operation of disclosure controls and procedures and concluded that your disclosure controls and procedures were effective. Please note that Item 308 of Regulation S-K requires a separate evaluation of your internal control over financial reporting. Please amend your filing to provide both the required management's report on internal control over financial reporting under Item 308 of Regulation S-K and management's conclusions on the effectiveness of your disclosure controls and procedures as part of your Evaluation of Disclosure Controls and Procedures section under Item 307 of Regulation S-K. 5.Please tell us your consideration of whether management’s failure to complete and disclose its report on internal control over financial reporting for two successive annual periods impacts its conclusions regarding the effectiveness of your disclosure controls and procedures as of the end of the fiscal year covered by the report and revise your disclosure as appropriate. In particular, please explain to us how you considered the definition of disclosure controls and procedures provided in Rule 13a-15(e), which indicates that effective controls and procedures would ensure that information required to be disclosed by the issuer is recorded, processed, summarized and reported within the time periods specified in the Commission’s rules and forms. 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.

FirstName LastNamePeter Mariani Comapany NameAxogen, Inc. April 27, 2020 Page 3 FirstName LastName Peter Mariani Axogen, Inc. April 27, 2020 Page 3 You may contact Lynn Dicker at (202) 551-3616 or Kevin Kuhar, Accounting Branch Chief, at (202) 551-3662 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences

Show Raw Text
United States securities and exchange commission logo
April 27, 2020
Peter Mariani
Chief Financial Officer
Axogen, Inc.
13631 Progress Boulevard, Suite 400
Alachua, FL 32615
Re:Axogen, Inc.
Form 10-K For the Fiscal Year Ended December 31, 2019
Filed February 24, 2020
File No. 001-36046
Dear Mr. Mariani:
            We have limited our review of your filing to the financial statements and related
disclosures 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 business days by providing the requested
information or advise 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, 2019
Item 7. Management's Discussion and Analysis
Comparison of the Years Ended December 31, 2019 and 2018, page 71
1.Please expand your results of operations discussion in future filings to quantify the impact
of each factor identified, including offsetting, as causing changes in results between
periods. For example, we note that your changes in revenue are attributable to a number of
factors, including increases in unit volume, net impacts of price increases and changes in
product mix. Please quantify the impact of each factor attributing to the increase, here, and
throughout your discussion, in accordance with Item 303(a)(3)(iii) of Regulation S-K and
Section III.D of SEC Release No. 33-6835.
2.We note the increase in your research and development expenses and that you have
multiple products in varying stages of development and clinical testing.  Please revise
future filings to provide more detail for your research and development expenses for each

 FirstName LastNamePeter Mariani
 Comapany NameAxogen, Inc.
 April 27, 2020 Page 2
 FirstName LastNamePeter Mariani
Axogen, Inc.
April 27, 2020
Page 2
period presented, including but not limited to by product candidate as well as by the
nature of the expenses. To the extent that you do not track expenses by product candidate,
please disclose as such.
Note 3. Summary of Significant Accounting Policies
Revenue Recognition, page 91
3.We note your disclosure that you do not provide disaggregated revenue because of the
similarity of products and arrangements. Please explain to us in greater detail your
consideration of ASC 606-10-50-5 and 55-89 through 55-91 in determining that
disaggregation of revenue is not required. In particular, describe what types of sales
information is reviewed by management to assess operating performance and the
similarity of your individual product gross margins impacting cash flows. As an example,
we note that you cite changes in product mix as a factor in increasing revenue for the year.
We also note in your recent earnings call that you identified Avance contributes over half
your revenue and growth and you also describe differences between the direct and indirect
sales channels. Lastly, tell us how you considered the disclosure requirements of ASC
280-10-50-40.
Item 9A. Controls and Procedures, page 114
4.We note that within Management’s Annual Report on Internal Control Over Financial
Reporting, you state that management evaluated the effectiveness of the design and
operation of disclosure controls and procedures and concluded that your disclosure
controls and procedures were effective.  Please note that Item 308 of Regulation S-K
requires a separate evaluation of your internal control over financial reporting.  Please
amend your filing to provide both the required management's report on internal control
over financial reporting under Item 308 of Regulation S-K and management's conclusions
on the effectiveness of your disclosure controls and procedures as part of your Evaluation
of Disclosure Controls and Procedures section under Item 307 of Regulation S-K.
5.Please tell us your consideration of whether management’s failure to complete and
disclose its report on internal control over financial reporting for two successive annual
periods impacts its conclusions regarding the effectiveness of your disclosure controls and
procedures as of the end of the fiscal year covered by the report and revise your disclosure
as appropriate. In particular, please explain to us how you considered the definition of
disclosure controls and procedures provided in Rule 13a-15(e), which indicates that
effective controls and procedures would ensure that information required to be disclosed
by the issuer is recorded, processed, summarized and reported within the time periods
specified in the Commission’s rules and forms.
            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.

 FirstName LastNamePeter Mariani
 Comapany NameAxogen, Inc.
 April 27, 2020 Page 3
 FirstName LastName
Peter Mariani
Axogen, Inc.
April 27, 2020
Page 3
            You may contact Lynn Dicker at (202) 551-3616 or Kevin Kuhar, Accounting Branch
Chief, at (202) 551-3662 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences