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HERON THERAPEUTICS, INC. /DE/
Response Received
1 company response(s)
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HERON THERAPEUTICS, INC. /DE/
Response Received
1 company response(s)
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HERON THERAPEUTICS, INC. /DE/
Response Received
1 company response(s)
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HERON THERAPEUTICS, INC. /DE/
Response Received
1 company response(s)
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HERON THERAPEUTICS, INC. /DE/
Awaiting Response
0 company response(s)
Medium
HERON THERAPEUTICS, INC. /DE/
Response Received
2 company response(s)
High - file number match
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Company responded
2018-07-30
HERON THERAPEUTICS, INC. /DE/
References: July 16, 2018
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2021-08-10
HERON THERAPEUTICS, INC. /DE/
References: July 15, 2021
HERON THERAPEUTICS, INC. /DE/
Awaiting Response
0 company response(s)
Medium
HERON THERAPEUTICS, INC. /DE/
Awaiting Response
0 company response(s)
High
HERON THERAPEUTICS, INC. /DE/
Awaiting Response
0 company response(s)
High
HERON THERAPEUTICS, INC. /DE/
Response Received
2 company response(s)
High - file number match
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Company responded
2012-09-05
HERON THERAPEUTICS, INC. /DE/
Summary
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HERON THERAPEUTICS, INC. /DE/
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2011-05-31
HERON THERAPEUTICS, INC. /DE/
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2011-07-27
HERON THERAPEUTICS, INC. /DE/
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HERON THERAPEUTICS, INC. /DE/
Awaiting Response
0 company response(s)
High
SEC wrote to company
2011-07-01
HERON THERAPEUTICS, INC. /DE/
References: June 13, 2011
Summary
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HERON THERAPEUTICS, INC. /DE/
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2011-05-31
HERON THERAPEUTICS, INC. /DE/
Summary
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HERON THERAPEUTICS, INC. /DE/
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2006-02-02
HERON THERAPEUTICS, INC. /DE/
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2006-02-06
HERON THERAPEUTICS, INC. /DE/
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HERON THERAPEUTICS, INC. /DE/
Awaiting Response
0 company response(s)
High
SEC wrote to company
2005-11-23
HERON THERAPEUTICS, INC. /DE/
Summary
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HERON THERAPEUTICS, INC. /DE/
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2005-10-31
HERON THERAPEUTICS, INC. /DE/
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2005-11-15
HERON THERAPEUTICS, INC. /DE/
References: October 31, 2005
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-12 | Company Response | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2025-09-12 | Company Response | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2025-09-11 | SEC Comment Letter | HERON THERAPEUTICS, INC. /DE/ | DE | 333-290143 | Read Filing View |
| 2025-09-11 | SEC Comment Letter | HERON THERAPEUTICS, INC. /DE/ | DE | 333-290142 | Read Filing View |
| 2023-08-30 | Company Response | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2023-08-28 | SEC Comment Letter | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2022-10-13 | SEC Comment Letter | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2022-10-13 | Company Response | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2021-08-30 | SEC Comment Letter | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2021-08-10 | Company Response | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2021-07-15 | SEC Comment Letter | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2018-08-22 | SEC Comment Letter | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2018-07-30 | Company Response | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2018-07-16 | SEC Comment Letter | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2012-09-05 | Company Response | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2012-08-31 | Company Response | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2012-08-30 | SEC Comment Letter | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2011-07-27 | Company Response | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2011-07-01 | SEC Comment Letter | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2011-06-03 | SEC Comment Letter | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2011-05-31 | SEC Comment Letter | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2011-05-31 | SEC Comment Letter | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2006-02-06 | Company Response | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2006-02-02 | SEC Comment Letter | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2005-11-23 | SEC Comment Letter | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2005-11-15 | Company Response | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2005-10-31 | SEC Comment Letter | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-11 | SEC Comment Letter | HERON THERAPEUTICS, INC. /DE/ | DE | 333-290143 | Read Filing View |
| 2025-09-11 | SEC Comment Letter | HERON THERAPEUTICS, INC. /DE/ | DE | 333-290142 | Read Filing View |
| 2023-08-28 | SEC Comment Letter | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2022-10-13 | SEC Comment Letter | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2021-08-30 | SEC Comment Letter | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2021-07-15 | SEC Comment Letter | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2018-08-22 | SEC Comment Letter | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2018-07-16 | SEC Comment Letter | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2012-08-30 | SEC Comment Letter | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2011-07-01 | SEC Comment Letter | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2011-06-03 | SEC Comment Letter | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2011-05-31 | SEC Comment Letter | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2011-05-31 | SEC Comment Letter | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2006-02-02 | SEC Comment Letter | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2005-11-23 | SEC Comment Letter | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2005-10-31 | SEC Comment Letter | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-12 | Company Response | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2025-09-12 | Company Response | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2023-08-30 | Company Response | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2022-10-13 | Company Response | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2021-08-10 | Company Response | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2018-07-30 | Company Response | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2012-09-05 | Company Response | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2012-08-31 | Company Response | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2011-07-27 | Company Response | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2006-02-06 | Company Response | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
| 2005-11-15 | Company Response | HERON THERAPEUTICS, INC. /DE/ | DE | N/A | Read Filing View |
2025-09-12 - CORRESP - HERON THERAPEUTICS, INC. /DE/
CORRESP 1 filename1.htm CORRESP Heron Therapeutics, Inc. 100 Regency Forest Drive, Suite 300 Cary, North Carolina 27518 September 12, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Tim Buchmiller Re: Heron Therapeutics, Inc. Registration Statement on Form S-3 File No. 333-290143 Filed September 9, 2025 Dear Mr. Buchmiller: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Heron Therapeutics, Inc. (the “ Compan y”) hereby requests acceleration of the effective date of the above referenced Registration Statement to 4:00 p.m., Eastern Time, on September 16, 2025, or as soon thereafter as practicable, or at such other time as the Company or its outside counsel, DLA Piper LLP (US), request by telephone that such Registration Statement be declared effective. Please contact Andrew P. Gilbert, of DLA Piper LLP (US), counsel to the Company, at (973) 520-2553, as soon as the registration statement has been declared effective, or if you have any other questions or concerns regarding this matter. Sincerely, HERON THERAPEUTICS, INC. By: /s/ Ira Duarte Name: Ira Duarte Title: Executive Vice President, Chief Financial Officer
2025-09-12 - CORRESP - HERON THERAPEUTICS, INC. /DE/
CORRESP 1 filename1.htm CORRESP Heron Therapeutics, Inc. 100 Regency Forest Drive, Suite 300 Cary, North Carolina 27518 September 12, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Tim Buchmiller Re: Heron Therapeutics, Inc. Registration Statement on Form S-3 File No. 333-290142 Filed September 9, 2025 Dear Mr. Buchmiller: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Heron Therapeutics, Inc. (the “ Compan y”) hereby requests acceleration of the effective date of the above referenced Registration Statement to 4:00 p.m., Eastern Time, on September 16, 2025, or as soon thereafter as practicable, or at such other time as the Company or its outside counsel, DLA Piper LLP (US), request by telephone that such Registration Statement be declared effective. Please contact Andrew P. Gilbert, of DLA Piper LLP (US), counsel to the Company, at (973) 520-2553, as soon as the registration statement has been declared effective, or if you have any other questions or concerns regarding this matter. Sincerely, HERON THERAPEUTICS, INC. By: /s/ Ira Duarte Name: Ira Duarte Title: Executive Vice President, Chief Financial Officer
2025-09-11 - UPLOAD - HERON THERAPEUTICS, INC. /DE/ File: 333-290143
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> September 11, 2025 Craig Collard Chief Executive Officer Heron Therapeutics, Inc. 100 Regency Forest Drive, Suite 300 Cary, North Carolina 27518 Re: Heron Therapeutics, Inc. Registration Statement on Form S-3 Filed September 9, 2025 File No. 333-290143 Dear Craig Collard: 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 Tim Buchmiller at 202-551-3635 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Emilio Ragosa, Esq. </TEXT> </DOCUMENT>
2025-09-11 - UPLOAD - HERON THERAPEUTICS, INC. /DE/ File: 333-290142
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> September 11, 2025 Craig Collard Chief Executive Officer Heron Therapeutics, Inc. 100 Regency Forest Drive, Suite 300 Cary, North Carolina 27518 Re: Heron Therapeutics, Inc. Registration Statement on Form S-3 Filed September 9, 2025 File No. 333-290142 Dear Craig Collard: 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 Tim Buchmiller at 202-551-3635 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Emilio Ragosa, Esq. </TEXT> </DOCUMENT>
2023-08-30 - CORRESP - HERON THERAPEUTICS, INC. /DE/
CORRESP 1 filename1.htm CORRESP Heron Therapeutics, Inc. 4242 Campus Point Court, Suite 200 | San Diego, CA 92121 August 29, 2023 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, DC 20549 Re: Heron Therapeutics, Inc. Registration Statement on Form S-3 (File No. 333-274167) To Whom it May Concern: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Heron Therapeutics, Inc. (the “Company”) hereby requests that the effective date of the above referenced registration statement (the “Registration Statement”) be accelerated to August 31, 2023, at 4:00 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Gibson, Dunn & Crutcher 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 obligations under the Act. Once the Registration Statement is effective, please orally confirm the event with our counsel, Gibson, Dunn & Crutcher LLP by calling Ryan A. Murr at (415) 393-8373. Very truly yours, Heron Therapeutics, Inc. By: /s/ Craig Collard Name: Craig Collard Title: Chief Executive Officer cc: Ryan A. Murr, Gibson, Dunn & Crutcher LLP
2023-08-28 - UPLOAD - HERON THERAPEUTICS, INC. /DE/
United States securities and exchange commission logo
August 28, 2023
Craig Collard
Executive Vice President, Chief Financial Officer
HERON THERAPEUTICS, INC. /DE/
4242 Campus Point Court
Suite 200
San Diego, California 92121
Re:HERON THERAPEUTICS, INC. /DE/
Registration Statement on Form S-3
Filled August 23, 2023
File No. 333-274167
Dear Craig Collard:
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 Tamika N. Sheppard at 202-551-8346 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Ryan A. Murr
2022-10-13 - UPLOAD - HERON THERAPEUTICS, INC. /DE/
United States securities and exchange commission logo
October 13, 2022
Barry Quart, Pharm.D.
Chief Executive Officer
Heron Therapeutics, Inc.
4242 Campus Point Court, Suite 200
San Diego, CA 92121
Re:Heron Therapeutics, Inc.
Registration Statement on Form S-3
Filed October 7, 2022
File No. 333-267781
Dear Barry Quart:
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 Jason Drory at 202-551-8342 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Branden C. Berns
2022-10-13 - CORRESP - HERON THERAPEUTICS, INC. /DE/
CORRESP 1 filename1.htm CORRESP Heron Therapeutics, Inc. 4242 Campus Point Court, Suite 200 San Diego, California 92121 (858) 251-4400 October 13, 2022 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, DC 20549 Attention: Jason Drory Re: Heron Therapeutics, Inc. Registration Statement on Form S-3 (File No. 333-267781) To Whom it May Concern: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Heron Therapeutics, Inc. (the “Company”) hereby requests that the effective date of the above referenced registration statement (the “Registration Statement”) be accelerated to October 18, 2022, at 4:00 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Gibson, Dunn & Crutcher 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 obligations under the Act. Once the Registration Statement is effective, please orally confirm the event with our counsel, Gibson, Dunn & Crutcher LLP by calling Branden C. Berns at (415) 393-4631. Very truly yours, Heron Therapeutics, Inc. By: /s/ Jeff Cohn Name: Jeff Cohn Title: Executive Director, Assistant General Counsel & Assistant Secretary cc: Ryan A. Murr, Gibson, Dunn & Crutcher LLP Branden C. Berns, Gibson, Dunn & Crutcher LLP
2021-08-30 - UPLOAD - HERON THERAPEUTICS, INC. /DE/
United States securities and exchange commission logo
August 30, 2021
Lisa Peraza
Vice President, Chief Accounting Officer
Heron Therapeutics, Inc.
4242 Campus Point Court, Suite 200
San Diego, CA 92121
Re:Heron Therapeutics, Inc.
Form 10-K for the Fiscal Years Ended December 31, 2020
Filed February 24, 2021
Dear Ms. Peraza:
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 Life Sciences
2021-08-10 - CORRESP - HERON THERAPEUTICS, INC. /DE/
CORRESP 1 filename1.htm hrtx-corresp.htm August 10, 2021 VIA EDGAR Mary Mast Angela Connell United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, D.C. 20549 Re: Heron Therapeutics, Inc. Form 10-K for the Fiscal Year Ended December 31, 2020 Filed February 24, 2021 File No. 001-33221 Ladies and Gentlemen: We are in receipt of the comments of the Staff (the “Staff”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”) set forth in the Staff’s letter dated July 15, 2021 (the “Letter”) to Ms. Lisa Peraza, Vice President, Chief Accounting Officer of Heron Therapeutics, Inc. (the “Company”), regarding the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020, filed on February 24, 2021. Each of your comments in the Letter is set forth below in italics, followed by our response in ordinary type. For ease of reference, the headings and numbered paragraphs below correspond to the headings and numbered comments in the Letter. Management's Discussion and Analysis Results of Operations Net Product Sales, page 71 1. Net product sales decreased from $146.0 million in 2019 to $88.6 million in 2020, of which $44.4 million related to a decline in CINVANTI net product sales and $13.0 million related to the decline in SUSTOL net product sales. You state that the decrease in CINVANTI net product sales was due to the impact of generic arbitrage and the decrease in SUSTOL sales was due to the discontinuation of discounting. Please tell us and consider revising in future filings to clarify the following: Company’s Response: We acknowledge the Staff’s comment. In response thereto, the Company provides the Staff with the information below. As more specifically described below, we further advise the Staff that in future filings with the Commission, we plan to expand certain aspects of our disclosure. • what you mean by generic arbitrage and how that contributed to the decline in net product sales, Company’s Response: The Centers for Medicare and Medicaid Services reimbursement rates for any buy-and-bill products are based on the Average Selling Price (“ASP”) of that product, including any generic products with the same J-code, plus 6%. ASP is based on a historical four-quarter rolling average calculation, which becomes effective two quarters later. This four-quarter averaging period and two-quarter lag means that when generic products first enter the market, they benefit from being able to be reimbursed at a much higher ASP relative to the actual sale price. This period of time when generic products receive higher reimbursement rates than sale price is known as “generic arbitrage,” and it can last several quarters. • the expected impact that generic competition will have on your results of operations and liquidity in future periods, Company’s Response: See note below for the Company’s response. • why you expect growth of net product sales for CINVANTI, despite the generic competition, and Company’s Response: As noted in our Form 10-Q for the period ended June 30, 2021, we believe that the most significant impact of this generic arbitrage is over and we expect growth of net product sales for our oncology care franchise in 2021 and beyond. As the financial benefit of using generic products diminishes, we anticipate an increase in demand for CINVANTI. For example, during the second quarter of 2021, CINVANTI demand increased by 22%, compared to the first quarter of 2021. Although the impact of the generic arbitrage continues to linger in certain accounts, we expect to see an estimated 5% to 10% growth in the third quarter of 2021 for our oncology care franchise net product sales, compared to net product sales for the second quarter of 2021. At this time, we are unable to reasonably quantify the impact that the lingering generic arbitrage will have on our CINVANTI sales trends with greater specificity. We will continue to consider whether we are able to reasonably quantify the impact and whether disclosure of that nature is appropriate. • what effect discounting vs. generic competition had on SUSTOL net product sales. Company’s Response: As noted in our Form 10-K for the year ended December 31, 2020, on October 1, 2019, we made a business decision to discontinue all discounting of SUSTOL to improve the reimbursement and net selling price of the product. During the period when no discounts were available for SUSTOL, purchasing SUSTOL became less attractive than other products that had lower acquisition costs, resulting in limited demand for SUSTOL. Now that we have reinstated the discounting for SUSTOL, we expect a return to growth in 2021 and beyond. During the second quarter of 2021, we had an increase in demand for SUSTOL of 108%, compared to the first quarter of 2021. Future disclosure will include wording similar to the following, which was included in our Form 10-Q for the period ended June 30, 2021 (new disclosures are in bold): Net Product Sales Net product sales for the three and six months ended June 30, 2021 were $22.4 million and $42.5 million, respectively, compared to $22.7 million and $48.1 million, respectively, for the same periods in 2020. For the three and six months ended June 30, 2021, net product sales of CINVANTI were $19.7 million and $38.2 million, respectively, compared to $22.6 million and $47.8 million, respectively, for the same periods in 2020. For the three and six months ended June 30, 2021, net product sales of SUSTOL were $2.7 million and $4.3 million, respectively, compared to $0.1 million and $0.3 million, respectively, for the same periods in 2020. On October 1, 2019, we made a business decision to discontinue all discounting of SUSTOL to improve the reimbursement and net selling price of the product, which resulted in significantly lower SUSTOL net product sales in 2020. In the first quarter of 2021, we reinstated the promotion and contracting of SUSTOL, resulting in higher net product sales for the three and six months ended June 30, 2021, compared to the same periods in 2020. The decrease in net product sales of CINVANTI for the three and six months ended June 30, 2021 was due to the COVID-19 pandemic related reduction in cancer screening procedures resulting in fewer new patient treatment starts along with the lingering impact of generic arbitrage. CMS reimbursement rates for any buy-and-bill products are based on the Average Selling Price (“ASP”) of that product, including any generic products with the same J-code, plus 6%. ASP is based on a historical four-quarter rolling average calculation, which becomes effective two quarters later. This four-quarter averaging period and two-quarter lag means that when generic products first enter the market, they benefit from being able to be reimbursed at a much higher ASP relative to the actual sale price. This period of time when generic products receive higher reimbursement rates than sale price is known as “generic arbitrage,” and it can last several quarters. Generic versions of EMEND® IV (fosaprepitant) launched in September 2019 and compete with CINVANTI. Although the impact of this generic arbitrage continues to linger in certain accounts, we expect growth of net product sales for our oncology care franchise in 2021 and beyond. Notes to Consolidated Financial Statements 6. Commitments and Contingencies Development Agreements, page 96 2. You state that in some of your development agreements with contract manufacturing organizations, you are required to meet minimum purchase obligations. We note that net product sales declined significantly from 2019 to 2020 and net product sales have continued to decline in the first quarter of 2021 compared to the quarter ended March 31, 2020. On page 75 you disclose that total purchase obligations of $43.9 million were not included in your consolidated financial statements for the year ended December 31, 2020. Please address the following: • Tell us if the $43.9 million represents the shortfall of the 2020 purchase obligations, and if so, why that amount is not required to be disclosed in the notes to the financial statements. Company’s Response: The $43.9 million does not represent a shortfall of the Company’s 2020 purchase obligations. The $43.9 million purchase obligations primarily consisted of commitments related to the manufacturing of ZYNRELEF and CINVANTI. ZYNRELEF was approved by the U.S. Food and Drug Administration in May 2021 and the product became commercially available in the U.S. on July 1, 2021. Although we saw a decline in sales for both CINVANTI and SUSTOL during 2020 as compared to 2019, for the reasons stated above we believe our oncology care franchise net product sales will continue to grow in 2021 and beyond. Despite the decline in sales during 2020, we did not have any shortfalls with respect to our minimum purchase obligations for CINVANTI or SUSTOL. • Clarify if you continue to have a shortfall in purchase obligations and the status of those minimum purchase obligations at each balance sheet date. Company’s Response: For the years ended December 31, 2019 and 2020, the Company did not have any shortfalls in its minimum purchase obligations. • Tell us why the minimum purchase obligations are not required to be disclosed in the notes to the financial statements pursuant to ASC 440-10-50. In this respect, it does not appear that an estimate is required to be made with “certainty”. Company’s Response: Regulation S-K Item 303(a)(5) requires broad disclosure of the Company’s unconditional purchase obligations within the MD&A, regardless of the specific terms of such obligations. However, ASC 440-10-50-4 only requires footnote disclosure of our unconditional purchase obligations that meet all three criteria set forth in ASC Topic 440-10-50-2. Of the $43.9 million of purchase obligations disclosed on page 75, only $0.6 million had a remaining term of more than one year (criteria 3), however, this obligation did not meet criteria 2 of ASC Topic 440-10-50-2. As such, we did not include any additional disclosure in our Notes to Consolidated Financial Statements within our Form 10-K for the year ended December 31, 2020. The Company acknowledges that information regarding purchase obligations is relevant to investors in understanding our business. In response to the Staff’s comments, and in an effort to further enhance the transparency of our footnote disclosures, the Company will enhance its footnote disclosure in future filings to include disclosure of all unconditional purchase obligations. Future disclosure will include wording similar to the following: At [Date], purchase obligations primarily consisted of non-cancellable commitments with third-party manufacturers in connection with the manufacturing of our commercial products. Total purchase obligations of [Amount] were not included in our consolidated financial statements for the year ended [Date] and are due within [period of time]. • Tell us if there are any penalties related to failing to meet the minimum purchase obligations and how failure to meet those purchase obligations has or may affect your results operations and financial condition. Company’s Response: As noted above, the Company did not have any shortfalls related to its minimum purchase commitments. As such, there were no penalties related to these obligations. If you have any questions or require additional information concerning the above, please do not hesitate to contact me at (858) 251-4460 or Ryan Murr at (415) 393-8373. Sincerely, /s/ Lisa Peraza Lisa Peraza Vice President, Chief Accounting Officer cc: David Szekeres, Executive Vice President, Chief Operating Officer Ryan Murr, Gibson, Dunn & Crutcher LLP
2021-07-15 - UPLOAD - HERON THERAPEUTICS, INC. /DE/
United States securities and exchange commission logo
July 15, 2021
Lisa Peraza
Vice President, Chief Accounting Officer
Heron Therapeutics, Inc.
4242 Campus Point Court, Suite 200
San Diego, CA 92121
Re:Heron Therapeutics, Inc.
Form 10-K for the Fiscal Years Ended December 31, 2020
Filed February 24, 2021
Dear Ms. Peraza:
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 Years Ended December 31, 2020
Management's Discussion and Analysis
Results of Operations
Net Product Sales, page 71
1.Net product sales decreased from $146.0 million in 2019 to $88.6 million in 2020, of
which $44.4 million related to a decline in CINVANTI net product sales and $13.0
million related to the decline in SUSTOL net product sales. You state that the decrease in
CINVANTI net product sales was due to the impact of generic arbitrage and the decrease
in SUSTOL sales was due to the discontinuation of discounting. Please tell us and
consider revising in future filings to clarify the following:
•what you mean by generic arbitrage and how that contributed to the decline in net
product sales,
•the expected impact that generic competition will have on your results of operations
and liquidity in future periods,
•why you expect growth of net product sales for CINVANTI, despite the generic
FirstName LastNameLisa Peraza
Comapany NameHeron Therapeutics, Inc.
July 15, 2021 Page 2
FirstName LastName
Lisa Peraza
Heron Therapeutics, Inc.
July 15, 2021
Page 2
competition, and
•what effect discounting vs. generic competition had on SUSTOL net product sales.
Notes to Consolidated Financial Statements
6. Commitments and Contingencies
Development Agreements, page 96
2.You state that in some of your development agreements with contract manufacturing
organizations, you are required to meet minimum purchase obligations. We note that net
product sales declined significantly from 2019 to 2020 and net product sales have
continued to decline in the first quarter of 2021 compared to the quarter ended March 31,
2020. On page 75 you disclose that total purchase obligations of $43.9 million were not
included in your consolidated financial statements for the year ended December 31, 2020.
Please address the following:
•Tell us if the $43.9 million represents the shortfall of the 2020 purchase obligations,
and if so, why that amount is not required to be disclosed in the notes to the financial
statements.
•Clarify if you continue to have a shortfall in purchase obligations and the status of
those minimum purchase obligations at each balance sheet date.
•Tell us why the minimum purchase obligations are not required to be disclosed in the
notes to the financial statements pursuant to ASC 440-10-50. In this respect, it does
not appear that an estimate is required to be made with "certainty".
•Tell us if there are any penalties related to failing to meet the minimum purchase
obligations and how failure to meet those purchase obligations has or may affect your
results operations and financial condition.
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.
You may contact Mary Mast at 202-551-3613 or Angela Connell at 202-551-3426 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2018-08-22 - UPLOAD - HERON THERAPEUTICS, INC. /DE/
August 22, 2018
Robert E. Hoffman
Chief Financial Officer and Senior Vice President, Finance
Heron Therapeutics, Inc.
4242 Campus Point Court, Suite 200
San Diego, California 92121
Re:Heron Therapeutics, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2017
Filed February 27, 2018
Form 10-Q for the Quarterly Period Ended March 31, 2018
Filed May 10, 2018
File No. 001-33221
Dear Mr. Hoffman:
We have completed our review of your filings. 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 Healthcare & Insurance
2018-07-30 - CORRESP - HERON THERAPEUTICS, INC. /DE/
CORRESP 1 filename1.htm CORRESP July 30, 2018 VIA EDGAR Andri Carpenter Keira Nakada United States Securities and Exchange Commission Division of Corporation Finance Office of Healthcare & Insurance Washington, D.C. 20549 Re: Heron Therapeutics, Inc. Form 10-K for the Fiscal Year Ended December 31, 2017 Filed February 27, 2018 Form 10-Q for the Quarterly Period Ended March 31, 2018 Filed May 10, 2018 File No. 001-33221 Ladies and Gentlemen: We are in receipt of the comments of the Staff (the “Staff”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”) set forth in the Staff’s letter dated July 16, 2018 (the “Letter”) to Mr. Robert E. Hoffman, Chief Financial Officer and Senior Vice President, Finance of Heron Therapeutics, Inc. (the “Company”), regarding the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017, filed on February 27, 2018 and the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2018, filed on May 10, 2018. Each of your comments in the Letter is set forth below in italics, followed by our response in ordinary type. For ease of reference, the headings and numbered paragraphs below correspond to the headings and numbered comments in the Letter. Form 10-Q for the Quarterly Period Ended March 31, 2018 Condensed Consolidated Balance Sheets, page 2 1. Regarding your accounts receivable at March 31, 2018, please provide us: Company’s Response: We acknowledge the Staff’s comment. In response thereto, the Company provides the Staff with the information below. As more specifically described below, we further advise the Staff that in future filings with the Commission, we plan to expand certain aspects of our disclosure, as described below. • A description of the payment terms; Company’s Response: In the ordinary course of our business, and consistent with industry practices, we have offered extended payments terms to our customers in connection with new product launches in anticipation of delays in reimbursement by government and commercial payers. As of March 31, 2018, these extended payment terms were evaluated in accordance with U.S. generally accepted accounting principles (“GAAP”) and did not impact the collectability of accounts receivables. We evaluate the collectability of our accounts receivable based on a number of factors, including the length of time the receivables are past due, the financial health of the customer and historical experience. We write off accounts receivable when a balance is deemed to be uncollectible. Effective January 1, 2018, we shortened payment terms for our first commercial product, SUSTOL® (granisetron) extended-release injection (“SUSTOL”). We advise the Staff that in future filings with the Commission, we intend to include the following disclosure, or similar disclosure, as and when appropriate, with respect to payment terms: We offered extended payment terms to our customers in connection with our product launches of SUSTOL and CINVANTI in October 2016 and January 2018, respectively, in anticipation of delays in reimbursement by government and commercial payers. Effective January 2018, we shortened payment terms to certain of our SUSTOL customers and expect to shorten payment terms of CINVANTI in the future. • The amount considered past due as per your payment terms; Company’s Response: As of March 31, 2018, we had no past due accounts receivable balances according to our payment terms. We advise the Staff that in future filings with the Commission, we intend to include disclosure with respect to amounts considered past due, as and when appropriate. • The amount due from each significant customer as well as the amount of revenue recognized from each during the three months ended March 31, 2018 and the year ended December 31, 2017; and Company’s Response: Our products are distributed in the U.S. through a limited number of specialty distributors and full line wholesalers (collectively, “Customers”) that resell our products to healthcare providers and hospitals, the end users. As of and for the three months ended March 31, 2018, our three largest Customers represented 100% of our accounts receivable and net product sales, respectively. As of and for the twelve months ended December 31, 2017, our two largest Customers represented 95% of our accounts receivable and 96% of our net product sales, respectively. For each of our three significant Customers, the table below includes the percentage of accounts receivable balances and net product sales as of March 31, 2018 and for the three months then ended, respectively, and as of December 31, 2017 and for the twelve months then ended, respectively: March 31, 2018 December 31, 2017 Customer Accounts Receivable Balance Net Product Sales Accounts Receivable Balance Net Product Sales Largest Customer 67 % 62 % 79 % 78 % Second Largest Customer 25 % 28 % 16 % 18 % Third Largest Customer 8 % 10 % 5 % 4 % We advise the Staff that in future filings with the Commission, we intend to include disclosure with respect to the percentage of net product sales and accounts receivable for each of our significant Customers, as and when appropriate. • The amount recorded for the allowance for doubtful accounts and the amount of bad debt expense recorded in your statements of operations for the three months ended March 31, 2018. Company’s Response: Allowance for doubtful accounts reflects accounts receivable balances that we believe to be uncollectible. In estimating the allowance for doubtful accounts, we consider: (1) our historical experience with collections and write-offs; (2) the credit quality of our Customers and any recent or anticipated changes thereto; and (3) the outstanding balances and past due amounts from our Customers. In the ordinary course of our business, and consistent with industry practices, we have offered extended payments terms to our customers in connection with new product launches in anticipation of delays in reimbursement by government and commercial payers. As of March 31, 2018, these extended payment terms were evaluated in accordance with GAAP and did not impact the collectability of accounts receivable. As of March 31, 2018, we determined that an allowance for doubtful accounts was not required. For the three months ended March 31, 2018, we did not write off any accounts receivable balances. We believe that our Customers will continue to pay their outstanding receivable balances as they become due according with our payment terms. We advise the Staff that in future filings with the Commission, we intend to include the following disclosure, or similar disclosure, as and when appropriate, with respect to the allowance for doubtful accounts: Allowance for doubtful accounts reflects accounts receivable balances that are believed to be uncollectible. In estimating the allowance for doubtful accounts, we consider: (1) our historical experience with collections and write-offs; (2) the credit quality of our Customers and any recent or anticipated changes thereto; and (3) the outstanding balances and past due amounts from our Customers. As of [Date], extended payment terms given to our Customers were evaluated in accordance with GAAP and did not impact the collectability of accounts receivables. As of [Date], we determined that an allowance for doubtful accounts was not required. For the three months ended [Date], we did not write off any accounts receivable balances. In your response, address your consideration as to disclosing the above in your future filings. Company Response: We advise the Staff that in future filings with the Commission, we intend provide additional disclosures with respect to the matters discussed in this comment, as set forth above. Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations Results of Operations for the Three Months Ended March 31 2018 and 2017 Net Product Sales, page 23 2. In your Form 8-K dated May 10, 2018, you separately quantify the revenues you recognized during the quarterly period ended March 31, 2018 by product and you attribute the decrease in the sale of SUSTOL to the entry of generic palonosetron in the first quarter of 2018, which is expected to have a continuing negative impact on the demand for SUSTOL. Please tell us why you did not include this information in your discussion herein and address the following: Company Response: We acknowledge the Staff’s comment and respectfully note that we did not include the information set forth in your comment in our Form 10-Q for the quarterly period ended March 31, 2018 because (1) we believe the information is not specifically required by Item 303 of Regulation S-K or the relevant sections of Regulation S-X and (2) we do not believe that the information is material to investors. In response to the Staff’s comment, the Company provides the Staff with the descriptions below. In addition, we advise the Staff that in light of the Staff’s comment, in future filings with the Commission, we plan to expand certain aspects of our disclosure, as described below. • Discuss and separately quantify the factors attributable to the net decrease of SUSTOL sales (e.g. the impact of changes in price, quantity, and adopting ASC 606); Company’s Response: Net product sales of SUSTOL for the three months ended March 31, 2018 were $6.4 million under the Financial Accounting Standards Board Accounting Standards Codification (“ASC”) Topic 606, which we adopted on January 1, 2018. Prior to the adoption of ASC Topic 606, we would have recognized net product sales of SUSTOL of $7.7 million for the three months ended March 31, 2018 in accordance with ASC Topic 605. Both the quantity and net selling price of SUSTOL decreased for the three months ended March 31, 2018, compared to the three months ended December 31, 2017. We believe that this decrease is primarily attributable to the entry of generic palonosetron into the marketplace for the three months ended March 31, 2018. We advise the Staff that in future filings with the Commission, we intend to include the following disclosure, or similar disclosure, as and when appropriate: Net product sales of SUSTOL for the [Time Period] ended [Date] were $[Net Product Sales Amount] under the new revenue recognition standard, ASC Topic 606, which we adopted on January 1, 2018. Under the prior revenue recognition standard, we would have recognized net product sales of SUSTOL of $[Net Product Sales Amount] for the [Time Period] ended [Date]. The entry of generic palonosetron in the first quarter of 2018 has had and is expected to have a several-quarter negative impact on provider demand for SUSTOL. • Discuss and quantify the impact the generic palonosetron is expected to have on your SUSTOL sales trend; Company’s Response: Generic palonosetron entered the marketplace in the first quarter of 2018. We expect the generic entry to have a several-quarter negative impact on provider demand for SUSTOL. At this time, we are unable to reasonably quantify the impact that the entry of generic palonosetron will have on our SUSTOL sales trends with greater specificity. We advise the Staff that in future filings with the Commission, we intend to include the disclosure set forth in the immediately preceding response. In addition, we will continue to consider whether we are able to reasonably quantify the impact that the entry of generic palonosetron will have on our SUSTOL sales trend, and whether disclosure of that nature is appropriate. • Discuss factors attributable to the fluctuations in your gross margin; Company’s Response: Fluctuations in our gross margin are primarily driven by changes in the net selling price of our products. We recognize product sales allowances as a reduction to net product sales in the same period the related net product sales are recognized. The most significant product sales allowances are for rebates and discounts offered and can vary depending on sales volumes and customer mix. Fluctuations in our gross margin are also driven by changes in costs related to our manufacturing process in the ordinary course of business. • Quantify the amount of CINVANTI inventories previously expensed; Company’s Response: The amount of CINVANTI inventory previously expensed was $1.4 million, which included costs for raw materials, labor and overhead for the manufacturing activities incurred prior to the U.S. Food and Drug Administration (“FDA”) approval of CINVANTI in November 2017. We advise the Staff that in future filings with the Commission, we intend to include the following disclosure, or similar disclosure, with respect to the amount of CINVANTI inventories previously expensed: Prior to FDA approval, $1.4 million of costs to manufacture CINVANTI were recorded to research and development expense in prior periods. As of March 31, 2018, all CINVANTI units that were manufactured prior to FDA approval had been sold. The Company began capitalizing raw materials, labor and overhead related to the manufacturing of CINVANTI following FDA approval. • Quantify the estimated selling value of zero/reduced-cost CINVANTI inventories remaining at March 31, 2018; Company’s Response: As of March 31, 2018, we do not have any remaining zero or reduced-cost CINVANTI inventory. We advise the Staff that in future filings with the Commission, we intend to include the disclosure set forth in the immediately preceding response. • Tell us when you expect to sell off all remaining zero/reduced-cost CINVANTI inventories, if any; and Company’s Response: As noted above, as of March 31, 2018, we do not have any remaining zero or reduced-cost CINVANTI inventory. • Tell us the gross margin you expect to earn on CINVANTI after all zero/reduced-cost CINVANTI inventories are sold. Company’s Response: We respectfully submit to the Staff that we cannot reasonably quantify the gross margin on CINVANTI given primarily to the effects on pricing of another manufacturer ceasing to market and distribute a competitive product. In addition, we respectfully submit to the Staff that we do not believe the gross margin information on CINVANTI is material to investors. If you have any questions or require additional information concerning the above, please do not hesitate to contact me at (858) 251-4448 or Ryan A. Murr at (415) 393-8373. Sincerely, /s/ Robert E. Hoffman Robert E. Hoffman Chief Financial Officer and Senior Vice President, Finance cc: David L. Szekeres, Senior VP, General Counsel, Business Development and Corporate Secretary, Heron Therapeutics, Inc. Ryan A. Murr, Gibson, Dunn & Crutcher LLP
2018-07-16 - UPLOAD - HERON THERAPEUTICS, INC. /DE/
July 16, 2018
Robert E. Hoffman
Chief Financial Officer and Senior Vice President, Finance
Heron Therapeutics, Inc.
4242 Campus Point Court, Suite 200
San Diego, California 92121
Re:Heron Therapeutics, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2017
Filed February 27, 2018
Form 10-Q for the Quarterly Period Ended March 31, 2018
Filed May 10, 2018
File No. 001-33221
Dear Mr. Hoffman:
We have limited our review of your filings 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-Q for the Quarterly Period Ended March 31, 2018
Condensed Consolidated Balance Sheets, page 2
1.Regarding you accounts receivable at March 31, 2018, please provide us:
•A description of the payment terms;
•The amount considered past due as per your payment terms;
•The amount due from each significant customer as well as the amount of revenue
recognized from each during the three months ended March 31, 2018 and the year
ended December 31, 2017; and
•The amount recorded for the allowance for doubtful accounts and the amount of bad
debt expense recorded in your statements of operations for the three months ended
FirstName LastNameRobert E. Hoffman
Comapany NameHeron Therapeutics, Inc.
July 16, 2018 Page 2
FirstName LastName
Robert E. Hoffman
Heron Therapeutics, Inc.
July 16, 2018
Page 2
March 31, 2018.
In your response, address your consideration as to disclosing the above in your future
filings.
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
Results of Operations for the Three Months Ended March 31 2018 and 2017
Net Product Sales, page 23
2.In your Form 8-K dated May 10, 2018, you separately quantify the revenues you
recognized during the quarterly period ended March 31, 2018 by product and you attribute
the decrease in the sale of SUSTOL to the entry of generic palonosetron in the first quarter
of 2018, which is expected to have a continuing negative impact on the demand for
SUSTOL. Please tell us why you did not include this information in your discussion
herein and address the following:
•Discuss and separately quantify the factors attributable to the net decrease of SUSTOL
sales (e.g. the impact of changes in price, quantity, and adopting ASC 606);
•Discuss and quantify the impact the generic palonosetron is expected to have on your
SUSTOL sales trend;
•Discuss factors attributable to the fluctuations in your gross margin;
•Quantify the amount of CIVANTI inventories previously expensed;
•Quantify the estimated selling value of zero/reduced-cost CIVANTI inventories
remaining at March 31, 2018;
•Tell us when you expect to sell off all remaining zero/reduced-cost CIVANTI
inventories, if any; and
•Tell us the gross margin you expect to earn on CIVANTI after all zero/reduced-cost
CIVANTI inventories are sold.
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.
You may contact Andri Carpenter at 202-551-3645 or Keira Nakada at 202-551-3659
with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
2012-09-05 - CORRESP - HERON THERAPEUTICS, INC. /DE/
CORRESP 1 filename1.htm Acceleration Request September 4, 2012 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-4628 Re: A.P. Pharma, Inc. (the “Company”) Acceleration Request for Registration Statement on Form S-3 File No. 333-183549 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, the undersigned, on behalf of the registrant, hereby requests that the effective date of the above-referenced registration statement be accelerated so that it will be declared effective at 4:00 p.m. (Eastern) on Thursday, September 6, 2012, or as soon thereafter as practicable. In making this acceleration request, the Company acknowledges 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 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 accuracy of the disclosure in the filing; and • the Company may not assert this action as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Sincerely, /s/ John B. Whelan John B. Whelan President, Chief Executive Officer and Chief Financial Officer cc: Ryan Murr, Esq. (Ropes & Gray LLP)
2012-08-31 - CORRESP - HERON THERAPEUTICS, INC. /DE/
CORRESP 1 filename1.htm Correspondence ROPES & GRAY LLP THREE EMBARCADERO CENTER SAN FRANCISCO, CA 94111-4006 WWW.ROPESGRAY.COM August 31, 2012 Ryan A. Murr (415) 315-6395 Ryan.murr@ropesgray.com VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-4628 Attention: Jeffrey Riedler Karen Ubell Daniel Greenspan Re: A.P. Pharma, Inc. Registration Statement on Form S-3 Filed August 24, 2012 File No. 333-183549 Ladies and Gentlemen: On behalf of our client, A.P. Pharma, Inc., a Delaware corporation (the “Company”), we are submitting the following response to the comment letter, dated August 29, 2012 (the “Comment Letter”), of the staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”) to the Company’s registration statement on Form S-3 (the “Registration Statement”). The Registration Statement was filed with the Commission on August 24, 2012. For reference purposes, the Staff’s comment, as reflected in the Comment Letter, is reproduced in bold and the corresponding responses of the Company are shown below the comments. 1. We note your shares are currently traded on the OTC Bulletin Board. As the OTC Bulletin Board is not a national securities exchange or an automated quotation system of a national securities association, it appears that you are not eligible to conduct a secondary offering on Form S-3 in reliance on General Instruction I.B.3. to Form S-3. Accordingly, please amend your registration statement to convert to a form for which you are eligible to conduct a secondary offering. Please see Securities Act Forms C&DI 116.12 (February 2009). RESPONSE TO COMMENT 1 In response to the Staff’s comment, the Company acknowledges that issuers quoted on the OTC Bulletin Board are unable to rely on General Instruction I.B.3 to conduct secondary offerings on Form S-3. However, we note that the Company has a non-affiliate float in excess of $75 million, which enables the Company to rely on General Instruction I.B.1. to Form S-3, as described in Securities Act Forms C&DI 116.14 (February 2009). As of August 22, 2012, the Company had outstanding approximately 302,205,000 shares of common stock, of which approximately 193,000,000 where held by non-affiliates. Also on August 22, 2012, the last reported sale price of the Company’s common stock on the OTC Bulletin Board was $0.73. Therefore, as of a date within 60 days of the filing of the Form S-3, the Company had a non-affiliate public float in excess of $140,000,000. Accordingly, we respectfully submit that the Company is permitted to use Form S-3 to register a secondary offering of its common stock. The Company hereby acknowledges that (i) the Company is responsible for the adequacy and accuracy of the disclosure in its filing, (ii) Staff comments or changes to disclosure based on Staff comments does not foreclose the Commission from taking any actions with respect to the Company’s filing, and (iii) it is the Staff’s position that the Company may not assert Staff comments as defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. If you should have any questions about this letter or require any further information, please call the undersigned at (415) 315-6395. Sincerely, /s/ Ryan A. Murr Ryan A. Murr cc: John B. Whelan, A.P. Pharma, Inc.
2012-08-30 - UPLOAD - HERON THERAPEUTICS, INC. /DE/
August 29, 2012 Via E -mail John B. Whelan Chief Executive Officer and Chief Financial Officer A.P. Pharma, Inc. 123 Saginaw Drive Redwood City, CA 94063 Re: A.P. Pharma, Inc. Registration Statement on Form S-3 Filed August 24, 2012 File No. 333-183549 Dear Mr. Whelan : We have limited our review of your registration statement to the issue we have addressed in our comment below. Please respond to this letter by amending your registration statement . If you do not believe our comment applies 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 any information you provide in response to our comment , we may have additional comments. General 1. We note your shares are currently traded on the OTC Bulletin Board. As the OTC Bulletin Board is not a national securities exchange or an automated quotati on system of a national securities association, it appears that you are not eligible to conduct a secondary offering on Form S -3 in reliance on General Instruction I.B. 3. to Form S -3. Accordingly, please amend your registration statement to convert to a form for which you are eligible to conduct a secondary offering. Please see Securities Act Forms C&DI 116.12 (February 2009). 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. John B. Whelan A.P. Pharma, Inc. August 29, 2012 Page 2 Notwithstanding our comments, in the event you request accelera tion 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 Commission 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 fo r 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 reques ts 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 review any amendment prior to the requested effective date of the registration statement. Please contact Karen Ubell at (202) 551 -3873 or me at (202) 551 -3715 with any questions. Sincerely, /s/ Daniel Greenspan for Jeffrey Riedler Assistant Director cc: Via E -mail Ryan Murr , Esq. Ropes & Gray LLP
2011-07-27 - CORRESP - HERON THERAPEUTICS, INC. /DE/
CORRESP 1 filename1.htm Acceleration Request A.P. Pharma, Inc. 123 Saginaw Drive Redwood City, CA 94063 July 27, 2011 VIA EDGAR Division of Corporation Finance Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549-4628 Attention: Jeffrey Riedler Johnny Gharib Daniel Greenspan Re: A.P. Pharma, Inc. Registration Statement on Form S-1 (File No. 333-174288) Filed on May 17, 2011 and Amended on June 14, 2011 and July 15, 2011 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, A.P. Pharma, Inc. (the “Issuer”), hereby requests that the effective date for the Registration Statement referred to above (the “Registration Statement”) be accelerated so that it will be declared effective by 4:00 p.m. Eastern Time on July 29, 2011 or as soon as possible thereafter. The Issuer acknowledges its responsibilities under the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended, as they relate to the proposed public offering of the securities specified in the above-referenced Registration Statement. In addition, in connection with our request for acceleration, we acknowledge that: • should the Securities and Exchange Commission (the “Commission”) or the staff, acting pursuant to delegated authority, declare the Registration Statement effective, it does not foreclose the Commission from taking any action with respect to the Registration Statement; • the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the Registration Statement effective, does not relieve the Issuer from its full responsibility for the adequacy and accuracy of the disclosure in the Registration Statement; and • the Issuer may not assert 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 notify Ryan Murr of Ropes & Gray LLP at 415-315-6300 as soon as the Registration Statement has been declared effective. Very truly yours, A.P. PHARMA, INC. By: /s/ John B. Whelan Name: John B. Whelan Title: Chief Executive Officer
2011-07-01 - UPLOAD - HERON THERAPEUTICS, INC. /DE/
July 1, 2011 Via E-mail John B. Whelan Chief Executive Officer and Chief Financial Officer AP Pharma, Inc. 123 Saginaw Drive Redwood City, California 94063 Re: AP Pharma, Inc. Registration Statement on Form S-1 Filed May 18, 2011 File No. 333-174288 Dear Mr. Whelan: We have reviewed your response letter dated June 13, 2011 and Amendment No. 1 to your Form S-1 and have the following comme nt. In our comment, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by amendi ng your registration statement and providing the requested information. Where you do not be lieve our comment applies 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 re gistration statement and the information you provide in response to this comment, we may have additional comments. 1. We note that you have not included the disc losure provided in response to our prior comment 9 regarding the Company’s financia l ability to make all payments on the overlying securities. Please include this disclosure in your next amendment to the registration statement. You may contact Johnny Ghar ib at (202) 551-3170, Daniel Greenspan at (202) 551- 3623 or me at (202) 551- 3715 with any questions. Sincerely, /s/ Daniel Greenspan for Jeffrey Riedler Assistant Director cc: Ryan Murr, Esq. Ropes & Gray LLP Three Embarcadero Center San Francisco, CA 9411
2011-06-03 - UPLOAD - HERON THERAPEUTICS, INC. /DE/
June 3, 2011 John B. Whelan Chief Executive Officer and Chief Financial Officer AP Pharma, Inc. 123 Saginaw Drive Redwood City, California 94063 Re: AP Pharma, Inc. Schedule 14A Filed May 17, 2011 File No. 001-33221 Dear Mr. Whelan: We have completed our review of your f iling. We remind you that our comments or changes to disclosure in res ponse to our comments do not for eclose the Commission from taking any action with respect to the company or th e filing and the company may not assert staff comments as a defense in any proceeding ini tiated by the Commission or any person under the federal securities laws of the United States. We urge all pers ons who are responsible for the accuracy and adequacy of the disclosure in the fi ling to be certain that the filing includes the information the Securities Exchange Act of 1934 and all applicable rules require. Sincerely, Jeffrey Riedler Assistant Director
2011-05-31 - UPLOAD - HERON THERAPEUTICS, INC. /DE/
May 31, 2011 John B. Whelan Chief Executive Officer and Chief Financial Officer AP Pharma, Inc. 123 Saginaw Drive Redwood City, California 94063 Re: AP Pharma, Inc. Registration Statement on Form S-1 Filed May 18, 2011 File No. 333-174288 Dear Mr. Whelan: We have limited our review of your registra tion 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 comments 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 re gistration statement and the information you provide in response to these comments, we may have additional comments. 1. We note that you are registering the sale of 271,221,610 shares. Given the size of the offering under this registration statement relative to the number of shares outstanding held by non-affiliates, the nature of the offeri ng and the total amount of shares being sold by the selling security holders, the trans action appears to be a primary offering. Accordingly, because you are not eligible to conduct a primary at-the-market offering under Rule 415(a)(4), the shares offered must be at a fixed price. In addition you must: • File a new registration statement for th e resale offering at the time of each conversion of convertible notes becaus e you are not eligible to conduct the offering on a delayed or continuous basis under Rule 415(a)(1)(x); • Identify the selling shareholders as underw riters in the registration statement; and • Include the price at which the underw riters will sell the securities. John B. Whelan AP Pharma, Inc. May 31, 2011 Page 2 If you disagree with our analysis, please a dvise the staff of the company’s basis for determining that the transaction is appropriately characterized as a transaction that is eligible to be made under Rule 415(a)(1)(i) . In your analysis, please address the following among any other relevant factors: • The date on which and the manner in whic h each selling shareholder received the shares and/or the overlying securities; • The relationship of each selling shareholder with the company, including an analysis of whether the selling sharehol der is an affiliate of the company; • Any relationships among the selling shareholders; • The dollar value of the shares registered in relation to the proceeds that the company received from the selling share holders for the securities, excluding amounts of proceeds that were returned (or will be returned) to the selling shareholders and/or their affiliates in fees or other payments; • The discount at which the shareholders will purchase the common stock underlying the convertible notes (or any re lated security, such as a warrant or option) upon conversion or exercise; and • Whether or not any of the selling shareholders is in the business of buying and selling securities. 2. Please provide us, with a view toward disclosu re in the prospectus, with the total dollar value of the securities underlyi ng the convertible notes that yo u have registered for resale (using the number of underlying securities that you have re gistered for resale and the market price per share for those securities on th e date of the sale of the convertible notes). 3. Please provide us, with a view toward disc losure in the prospectus, with tabular disclosure of the dollar amount of each paymen t (including the value of any payments to be made in common stock) in connection with the transaction that you have made or may be required to make to any selling shareholder, any affiliate of a selling shareholder, or any person with whom any selling shareholde r has a contractual re lationship regarding the transaction (including any interest paym ents, liquidated damages, payments made to “finders” or “placement agents,” and any othe r payments or potential payments). Please provide footnote disclosure of the terms of each such payment. Please do not include any repayment of principal on the conve rtible notes in this disclosure. Further, please provide us, with a view to ward disclosure in the prospectus, with disclosure of the net proceeds to the issuer fr om the sale of the convertible notes and the total possible payments to all selling shareholde rs and any of their affiliates in the first year following the sale of convertible notes. John B. Whelan AP Pharma, Inc. May 31, 2011 Page 3 4. Please provide us, with a view toward disc losure in the prospectus, with tabular disclosure of: • the total possible profit the selling share holders could realize as a result of the conversion discount for the securities underlyi ng the convertible notes, presented in a table with the following information disclosed separately: • the market price per share of the securi ties underlying the convertible notes on the date of the sale of the convertible notes; • the conversion price per share of the underl ying securities on the date of the sale of the convertible notes; • the total possible shares underlying the c onvertible notes (assuming no interest payments and complete conversion throughout the term of the note); • the combined market price of the total number of shares underlying the convertible notes, calculated by using the market price pe r share on the date of the sale of the convertible notes and th e total possible shar es underlying the convertible notes; • the total possible shares the selling shar eholders may receive and the combined conversion price of the total number of shares underlying the convertible notes calculated by using the conversion price on th e date of the sale of the convertible notes and the total possibl e number of shares the selling shareholders may receive; and • the total possible discount to the market price as of th e date of the sale of the convertible notes, calculated by subtracti ng the total conversion price on the date of the sale of the convertible notes from the combined market price of the total number of shares underlying the convertible notes on that date. If there are provisions in the convertible notes that could re sult in a change in the price per share upon the occurrence of certain events, please provide additional tabular disclosure as appropriate. For example, if the conversion price per share is fixed unless and until the market price falls below a stated price, at which point the conversion price per share drops to a lower price, pl ease provide addi tional disclosure. 5. Please provide us, with a view toward disc losure in the prospectus, with tabular disclosure of: • the total possible profit to be realized as a result of any conversion discounts for securities underlying any other warrants, options, notes, or othe r securities of the John B. Whelan AP Pharma, Inc. May 31, 2011 Page 4 issuer that are held by the selling shareholders or any affiliates of the selling shareholders, presented in a table with th e following information disclosed separately: • market price per share of the underlying secu rities on the date of the sale of that other security; • the conversion/exercise price per share as of the date of the sale of that other security, calculated as follows: - if the conversion/exercise price per share is set at a fixed price, use the price per share on the date of the sa le of that othe r security; and - if the conversion/exercise price per sh are is not set at a fixed price and, instead, is set at a floating rate in re lationship to the market price of the underlying security, use the conversion/ex ercise discount rate and the market rate per share on the date of the sale of that other security and determine the conversion price per shar e as of that date; • the total possible shares to be received under the partic ular securities (assuming complete conversion/exercise); • the combined market price of the total number of underlying shares, calculated by using the market price per share on the date of the sale of that other security and the total possible shares to be received; • the total possible shares to be received and the combin ed conversion price of the total number of shares underlying that other security calculated by using the conversion price on the date of the sale of that other security and the total possible number of underl ying shares; and • the total possible discount to the market price as of the date of the sale of that other security, calculated by subtracting th e total conversion/exercise price on the date of the sale of that other security from the combined market price of the total number of underlying shares on that date. 6. Please provide us, with a view toward disc losure in the prospectus, with tabular disclosure of: • the gross proceeds paid or payable to the i ssuer in the convertible notes transaction; • all payments that have been made or that may be required to be made by the issuer that are disclosed in response to comment 3; • the resulting net proceeds to the issuer; and John B. Whelan AP Pharma, Inc. May 31, 2011 Page 5 • the combined total possible profit to be realized as a result of any conversion discounts regarding the securi ties underlying the convert ible notes and any other warrants, options, notes, or othe r securities of the issuer that are held by the selling shareholders or any affiliates of the selli ng shareholders that is disclosed in response to comments 4 and 5. Further, please provide us, with a view to ward disclosure in the prospectus, with disclosure – as a percentage – of the total amount of all possi ble payments as disclosed in response to comment 3 and the total possible di scount to the market price of the shares underlying the convertible notes as disclosed in response to comment 4 divided by the net proceeds to the issuer from the sale of the c onvertible notes, as well as the amount of that resulting percentage aver aged over the term of the convertible notes. 7. Please provide us, with a view toward disc losure in the prospectus, with tabular disclosure of all prior securities transact ions between the issuer (or any of its predecessors) and the selling shareholders, any affiliates of the selling shareholders, or any person with whom any selling shareholde r has a contractual re lationship regarding the transaction (or any predecessors of thos e persons), with the table including the following information disclosed separately for each transaction: • the date of the transaction; • the number of shares of the class of securi ties subject to the transaction that were outstanding prior to the transaction; • the number of shares of the class of securi ties subject to the transaction that were outstanding prior to the transaction and held by persons other than the selling shareholders, affiliates of the company, or affiliates of the selling shareholders; • the number of shares of the class of securi ties subject to the transaction that were issued or issuable in connection with the transaction; • the percentage of total issued and outstanding securities that were issued or issuable in the transaction (assuming full issuance), with the percentage calculated by taking the number of shares issued and outstanding prior to the applicable transaction and held by persons other than the selling sh areholders, affiliates of the company, or affiliates of the selling shareholders, and dividing that number by the number of shares issued or issuable in connect ion with the applic able transaction; • the market price per share of the class of securities subject to the transaction immediately prior to the tr ansaction (reverse split ad justed, if necessary); and • the current market price per share of the cla ss of securities subject to the transaction (reverse split adjusted, if necessary). John B. Whelan AP Pharma, Inc. May 31, 2011 Page 6 8. Please provide us, with a view toward disc losure in the prospectus, with tabular disclosure comparing: • the number of shares outstanding prior to th e convertible notes transaction that are held by persons other than the selling sh areholders, affiliates of the company, and affiliates of the selling shareholders; • the number of shares registered for resale by the selling shareholders or affiliates of the selling shareholders in prior registration statements; • the number of shares registered for resale in those prior regi stration statements by the selling shareholders or affiliates of the selling shareholders that continue to be held by the selling shareholders or affiliates of the selling shareholders; • the number of shares that have been sold in prior registered resale transactions by the selling shareholders or affiliates of the selling shareholders; and • the number of shares registered for resale on behalf of the selling shareholders or affiliates of the selling shareholders in the current transaction. In this analysis, the calculation of the number of outstanding shares should not include any securities underl ying any outstanding convertib le securities, options, or warrants. 9. Please provide us, with a view toward disclo sure in the prospectus , with the following information: • whether the issuer has the in tention, and a reasonable basi s to believe that it will have the financial ability, to make all payments on the overlying securities; and • whether – based on information obtained from the selling shareholders – any of the selling shareholders have an existing s hort position in the company’s common stock and, if any of the selling shareholders have an existing short position in the company’s stock, the following additional information: - the date on which each such selling share holder entered into that short position; and - the relationship of the date on which each such selling shareholder entered into that short position to the date of the announcement of the convertible notes transaction and the filing of the registration statement ( e.g., before or after the announcement of the convertible notes trans action, before the filing or after the filing of the registrati on statement, etc.). John B. Whelan AP Pharma, Inc. May 31, 2011 Page 7 10. Please provide us, with a view toward disclosure in the prospectus, with: • a materially complete description of the relationships and arrangements that have existed in the past three years or are to be performed in the futu re between the issuer (or any of its predecessors) and the selli ng shareholders, any affiliates of the selling shareholders, or any person with whom any selling shareholder has a contractual relationship regarding the transaction (or a ny predecessors of those persons) – the information provided should include, in reason able detail, a complete description of the rights and obligations of the parties in connection with the sale of the convertible notes; and • copies of all agreements between the issuer (or any of its predecessors) and the selling shareholders, any affiliates of the selling shareholders, or any person with whom any selling shareholder has a c ontractual relationship regard ing the transaction (or any predecessors of those persons) in connection wi th the sale of the convertible notes. If it is your view that such a description of the relationships and arrangements between and among those parties already is presented in the prospectus and that all agreements between and/or among those parties are included as exhibits to the registration statement, please provide us with confirmati on of your view in this regard. 11. Please provide us, with a view toward disclosu re in the prospectus, with a description of the method by which the company determined the number of shares it seeks to re
2006-02-06 - CORRESP - HERON THERAPEUTICS, INC. /DE/
<DOCUMENT> <TYPE>CORRESP <SEQUENCE>1 <FILENAME>filename1.txt <TEXT> February 6, 2006 Ms. Vanessa Robertson Staff Accountant Securities and Exchange Commission Division of Corporate Finance 100 F. Street, N.E. Washington, D.C. 20549 RE: A.P. Pharma, Inc. Form 8-K filed on February 1, 2006 Dear Ms. Robertson, This letter responds to the comments of the staff of the Securities and Exchange Commission (the "Staff") set forth in the letter to Michael O'Connell dated February 2, 2006 in connection with the above referenced 8-K filing. Comment No. 1 ------------- Item 4.01(a) ------------ Please revise the third paragraph of your filing to state whether during the registrant's two most recent fiscal years and any subsequent interim period preceding resignation, there were any disagreements with the former accountant as described in Item 304(a)(1)(iv) of Regulation S-K. You should specify the "subsequent interim period" as the "interim period through January 26, 2006". Response to Comment No. 1 ------------------------- We have revised the third paragraph of our filing to state that there were no disagreements with Ernst & Young on any matters of accounting principles or practices, financial statement disclosure or auditing scope or procedure in connection with the audits of the Company's financial statements for each of the two years ended December 31, 2004 and 2003 and for the interim period subsequent to December 31, 2004 through February 6, 2006. This revised Form 8-K/A is being filed with the Securities and Exchange Commission on February 6, 2006. Comment No. 2 ------------- To the extent that you make changes to the Form 8-K to comply with our comment, please obtain and file an updated Exhibit 16 letter from the former accountant stating whether the accountant agrees with the statements made in your revised Form 8-K. Response to Comment No. 2 ------------------------- We have obtained and are filing an updated Exhibit 16 letter from Ernst & Young. The Company acknowledges that: (i) it is responsible for the adequacy and accuracy of the disclosure in the filing, (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. We hope that this response adequately addresses your comments. Please contact the undersigned at (650) 366-2626 if you have any questions regarding our response to the Staff's comment letter. Sincerely, /s/Gordon Sangster ------------------ Gordon Sangster Chief Financial Officer </TEXT> </DOCUMENT>
2006-02-02 - UPLOAD - HERON THERAPEUTICS, INC. /DE/
Via Facsimile and U.S. Mail
Mail Stop 6010
February 2, 2006
Michael O’Connell
President and Chief Executive Officer
A.P. Pharma, Inc.
123 Saginaw Drive
Redwood City, CA 94063
Re: A.P. Pharma, Inc.
Item 4.01 Form 8-K
Filed February 1, 2006
File No. 000-16109
Dear Mr. O’Connell:
We have reviewed your filing and have the following comments. Where
indicated, we think you should re vise your document 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.
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 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 any other aspect of our
review. Feel free to call us at the telephone number listed at the end of this letter.
Item 4.01(a)
1. Please revise the third paragraph of your filing to state whether during the
registrant’s two most recent fiscal ye ars and any subsequent interim period
preceding resignation, there were any disa greements with the former accountant
as described in Item 304(a)(1)(iv) of Regulation S-K. You should specify the
“subsequent interim period” as the “i nterim period through January 26, 2006”.
Michael O’Connell
A.P. Phar ma, Inc.
February 2, 2006
Page 2
2. To the extent that you make changes to the Form 8-K to comply with our
comment, please obtain and file an update d Exhibit 16 letter from the former
accountant stating whether the accountant ag rees with the statements made in
your revised Form 8-K.
As appropriate, please amend your filing and respond to these comments within
five business days or tell us when you will re spond. You may wish to provide us with
marked copies of the amendment to expedite our review. Please furnish a cover letter with your amendment that keys your responses to our comments and provides any
requested information. Detailed cover letters greatly facilitate 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 the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes all in formation required under
the Securities Exchange Act of 1934 and th at they have provided all information
investors require for an informed invest ment decision. Since the company and its
management are in possession of all facts re lating 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 co mments, please provide, in your letter, a
statement from the company acknowledging that:
the company is responsible for the adequacy and accuracy of the disclosure 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 federal 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 staff of the Divi sion of Corporation Fi nance in our review
of your filing or in response to our comments on your filing.
If you have any questions, please call me at (202) 551-3649.
S i n c e r e l y ,
Vanessa Robertson
S t a f f A c c o u n t a n t
2005-11-23 - UPLOAD - HERON THERAPEUTICS, INC. /DE/
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
Via Facsimile and U.S. Mail
Mail Stop 6010
November 22, 2005
Mr. Gordon Sangster
Chief Financial Officer and
Principal Financial and Accounting Officer
AP Pharma, Inc.
123 Saginaw Drive
Redwood City, California 94063
Re: AP Pharma, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2004
File No. 000-16109
Dear Mr. Sangster:
We have completed our review of your Form 10-K and have no
further comments at this time.
Sincerely,
Jim Atkinson
Accounting Branch Chief
</TEXT>
</DOCUMENT>
2005-11-15 - CORRESP - HERON THERAPEUTICS, INC. /DE/
<DOCUMENT>
<TYPE>CORRESP
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
November 15, 2005
Mr. Jim B. Rosenberg
Senior Assistant Chief Accountant
Securities and Exchange Commission
Division of Corporate Finance
450 Fifth Street, N.W.
Washington D.C. 20549
RE: A.P. Pharma, Inc.
Form 10-K for the period ended December 31, 2004
Dear Mr. Rosenberg:
This letter responds to the comment of the staff of the
Securities and Exchange Commission (the "Staff") set forth
in the letter dated October 31, 2005 in connection with the
above referenced 10-K filing.
Comment No. 1
-------------
Note 10 - Discontinued Operations
---------------------------------
Analytical Standards Division
-----------------------------
Please explain to us your basis for including the net
present value of the guaranteed minimum royalties in
calculating the gain on the disposal of these operations.
Include any references to the specific paragraphs within the
applicable authoritative literature upon which you relied in
this determination. Also tell us the amount of these future
minimum royalties, the amount you are included in your gain
calculation, and how the anticipated receipt of the
royalties is reflected in your financial statements,
particularly the statement of financial position.
Response to Comment No. 1
-------------------------
On February 13, 2003, we completed the sale of our
Analytical Standards division to GFS Chemicals, Inc.
("GFS"), a private company based in Columbus, Ohio. In this
transaction, our goal was to achieve total consideration for
this business of approximately $2.5 million, commensurate
with our estimate of its fair value at that time. We
achieved this value by agreeing to accept $2.1 million in
cash upon the execution of the transaction and to accept
guaranteed payments aggregating $425,000 over a period of
five years following the execution of the transaction. The
guaranteed payments were described in the agreement as
"minimum royalty payments" so any royalties owed would take
into account these guaranteed payments. However, regardless
of whether any sales by GFS occurred (which would result in
royalty amounts payable to AP Pharma), GFS would be required
to make the guaranteed payments owed under the arrangement
or they would be in breach of the contract. Therefore, we
ascertained that these payments were akin to a financing
arrangement. We considered the collectibility of these
guaranteed payments and determined that based on the
financial health of GFS, collectibility of the amounts was
assured at the execution of the transaction. Therefore, we
included the guaranteed payment amounts in our determination
of the gain on the sale of this business.
We applied the provisions of SFAS144, APB 30 and SFAS141 in
our accounting for this transaction. Because the amounts
were determinable, unconditionally guaranteed and
collectibility was assured, the entire amount of the
aggregate payments, or $425,000, was included in the gain
from the disposition of this business. Due to the long
payment period (i.e., five years), we computed the net
present value of these payments.
The entire gain (including the net present value of the
guaranteed payments) was included in the statement of
operations for the year ended December 31, 2003 in the
caption "Gain on disposition of discontinued operations, net
of taxes". This caption is included in discontinued
operations in this statement of operations. The amounts
representing the unpaid portion of the net present value of
the guaranteed payments are included in the asset captions
"Prepaids and other current assets" and "Other long-term
assets", and classification between short term and long term
is based on the timing of the related payments.
We hope that this response above adequately addresses your
comment. In accordance with your request, this response
letter is being filed on EDGAR. Please contact the
undersigned at (650) 366-2626, if you have any questions
regarding our response to the Staff's comment letter.
Sincerely,
/S/ Gordon Sangster
-------------------
Gordon Sangster
Chief Financial Officer
</TEXT>
</DOCUMENT>
2005-10-31 - UPLOAD - HERON THERAPEUTICS, INC. /DE/
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
Via Facsimile and U.S. Mail
Mail Stop 6010
October 31, 2005
Mr. Gordon Sangster
Chief Financial Officer and
Principal Financial and Accounting Officer
AP Pharma, Inc.
123 Saginaw Drive
Redwood City, California 94063
Re: AP Pharma, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2004
File No. 000-16109
Dear Mr. Sangster:
We have limited our review to only your financial statements
and related disclosures and do not intend to expand our review to
other portions of your document. In our comment, we ask you to
provide us with information so we may better understand your
disclosure. Please be as detailed as necessary in your
explanation.
After reviewing this information, we may 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 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 - December 31, 2004
Financial Statements
Note 10 - Discontinued Operations
Analytical Standards Division
1. Please explain to us your basis for including the net present
value of the guaranteed minimum royalties in calculating the gain
on
the disposal of these operations. Include any references to the
specific paragraphs within the applicable authoritative literature
upon which you relied in this determination. Also tell us the
amount
of these future minimum royalties, the amount you are included in
your gain calculation, and how the anticipated receipt of the
royalties is reflected in your financial statements, particularly
the
statement of financial position.
Please respond to this comment within 10 business days or
tell
us when you will provide us with a response. Please furnish a
letter
that keys your response to our comment and provide the requested
information. Detailed letters greatly facilitate our review.
Please
file your letter on EDGAR under the form type label CORRESP.
You may contact Tabatha Akins, Staff Accountant, at (202)
551-
3658 or James Atkinson, Accounting Branch Chief, at (202) 551-3674
if
you have questions regarding comments on the financial statements
and
related matters. Please contact me at (202) 551-3679 with any
other
questions.
Sincerely,
Jim B. Rosenberg
Senior Assistant Chief
Accountant
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Mr. Gordon Sangster
AP Pharma, Inc.
October 31, 2005
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