<SEC-DOCUMENT>0001564590-21-043096.txt : 20210928
<SEC-HEADER>0001564590-21-043096.hdr.sgml : 20210928
<ACCEPTANCE-DATETIME>20210810161605
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0001564590-21-043096
CONFORMED SUBMISSION TYPE:	CORRESP
PUBLIC DOCUMENT COUNT:		2
FILED AS OF DATE:		20210810

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			HERON THERAPEUTICS, INC. /DE/
		CENTRAL INDEX KEY:			0000818033
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				942875566
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		CORRESP

	BUSINESS ADDRESS:	
		STREET 1:		4242 CAMPUS POINT COURT, SUITE 200
		CITY:			SAN DIEGO
		STATE:			CA
		ZIP:			92121
		BUSINESS PHONE:		8582514400

	MAIL ADDRESS:	
		STREET 1:		4242 CAMPUS POINT COURT, SUITE 200
		CITY:			SAN DIEGO
		STATE:			CA
		ZIP:			92121

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	AP PHARMA INC /DE/
		DATE OF NAME CHANGE:	20010511

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ADVANCED POLYMER SYSTEMS INC /DE/
		DATE OF NAME CHANGE:	19920703
</SEC-HEADER>
<DOCUMENT>
<TYPE>CORRESP
<SEQUENCE>1
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<p style="margin-top:12pt;margin-bottom:0pt;margin-left:1.03%;text-indent:0%;font-family:Times New Roman;font-size:12pt;">&nbsp;</p>
<p style="margin-top:12pt;margin-bottom:0pt;text-indent:-2.06%;font-family:Cambria;font-size:12pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><img src="gtpuqvb24hsz000001.jpg" title="" alt="" style="width:241px;height:113px;"></p>
<p style="line-height:12pt;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">August 10, 2021</p>
<p style="line-height:12pt;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="line-height:12pt;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><font style="text-decoration:underline;">VIA EDGAR</font></p>
<p style="line-height:12pt;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Mary Mast</p>
<p style="line-height:12pt;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Angela Connell</p>
<p style="line-height:12pt;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">United States Securities and Exchange Commission</p>
<p style="line-height:12pt;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Division of Corporation Finance</p>
<p style="line-height:12pt;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Office of Life Sciences</p>
<p style="line-height:12pt;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">100 F Street, NE</p>
<p style="line-height:12pt;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Washington, D.C. 20549</p>
<p style="line-height:12pt;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="line-height:12pt;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Re: Heron Therapeutics, Inc.</p>
<p style="line-height:12pt;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Form 10-K for the Fiscal Year Ended December 31, 2020</p>
<p style="line-height:12pt;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Filed February 24, 2021</p>
<p style="line-height:12pt;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">File No. 001-33221</p>
<p style="line-height:12pt;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="line-height:12pt;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Ladies and Gentlemen:</p>
<p style="line-height:12pt;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="line-height:12pt;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">We are in receipt of the comments of the Staff (the &#8220;<font style="text-decoration:underline;">Staff</font>&#8221;) of the Division of Corporation Finance of the Securities and Exchange Commission (the &#8220;<font style="text-decoration:underline;">Commission</font>&#8221;) set forth in the Staff&#8217;s letter dated July 15, 2021 (the &#8220;<font style="text-decoration:underline;">Letter</font>&#8221;) to Ms. Lisa Peraza, Vice President, Chief Accounting Officer of Heron Therapeutics, Inc. (the &#8220;<font style="text-decoration:underline;">Company</font>&#8221;), regarding the Company&#8217;s Annual Report on Form 10-K for the fiscal year ended December 31, 2020, filed on February 24, 2021.</p>
<p style="line-height:12pt;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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.</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Arial;font-style:normal;text-transform:none;font-variant: normal;"><font style="text-decoration:underline;">Management's Discussion and Analysis</font></p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Arial;font-style:normal;text-transform:none;font-variant: normal;"><font style="text-decoration:underline;">Results of Operations</font></p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Arial;font-style:normal;text-transform:none;font-variant: normal;"><font style="text-decoration:underline;">Net Product Sales, page 71</font></p>
<p style="margin-top:0pt;line-height:12pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
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<p style="text-align:left;margin-bottom:0pt;margin-top:0pt;line-height:12pt;font-weight:normal;font-style:italic;color:#auto;font-size:10pt;font-family:Arial;text-transform:none;font-variant: normal;letter-spacing:0pt;"><font style="font-weight:normal;font-style:italic;text-decoration:none;Background-color:#auto;color:#auto;font-size:10pt;font-family:Arial;text-transform:none;font-variant: normal;letter-spacing:0pt;">1.</font></p></td>
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<p style="text-align:left;margin-bottom:0pt;margin-top:0pt;line-height:12pt;font-weight:normal;font-style:italic;color:#auto;text-transform:none;font-variant: normal;letter-spacing:0pt;font-family:Cambria;font-size:11pt;"><font style="Background-color:#auto;text-decoration:none;"></font><font style="font-style:normal;color:#000000;"></font><font style="font-size:10pt;font-family:Arial;color:#000000;">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:</font></p></td></tr></table></div>
<p style="margin-bottom:0pt;line-height:12pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;margin-left:8.25%;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Arial;font-style:normal;text-transform:none;font-variant: normal;"><font style="text-decoration:underline;">Company&#8217;s Response:</font></p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;margin-left:8.25%;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">We acknowledge the Staff&#8217;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.</p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;margin-left:8.25%;text-indent:-4.12%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-style:italic;font-size:10pt;font-family:Arial;font-weight:normal;text-transform:none;font-variant: normal;"><br /></p>
<p style="text-align:center;margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:12pt;">&nbsp;</p>
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<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:12pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:12pt;">&nbsp;</p>
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<p style="text-align:left;margin-bottom:0pt;margin-top:0pt;line-height:12pt;font-weight:normal;font-style:normal;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"><font style="font-weight:normal;font-style:normal;text-decoration:none;Background-color:#auto;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"></font><font style="font-size:10pt;font-family:'Times New Roman'">&#8226;</font></p></td>
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<p style="text-align:left;margin-bottom:0pt;margin-top:0pt;line-height:12pt;font-weight:normal;font-style:normal;color:#auto;text-transform:none;font-variant: normal;letter-spacing:0pt;font-family:Cambria;font-size:11pt;"><font style="Background-color:#auto;text-decoration:none;"></font><font style="color:#000000;"></font><font style="font-style:italic;font-size:10pt;font-family:Arial;color:#000000;">what you mean by generic arbitrage and how that contributed to the decline in net product sales,</font></p></td></tr></table></div>
<p style="margin-bottom:0pt;line-height:12pt;margin-top:0pt;margin-left:8.25%;text-indent:-4.12%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;margin-left:8.25%;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Arial;font-style:normal;text-transform:none;font-variant: normal;"><font style="text-decoration:underline;">Company&#8217;s Response:</font></p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;margin-left:8.25%;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><a name="_Hlk78882263"></a>The Centers for Medicare and Medicaid Services reimbursement rates for any buy-and-bill products are based on the Average Selling Price (&#8220;ASP&#8221;) 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 &#8220;generic arbitrage,&#8221; and it can last several quarters.</p>
<p style="margin-top:0pt;line-height:12pt;margin-bottom:0pt;margin-left:6.19%;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
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<p style="text-align:left;margin-bottom:0pt;margin-top:0pt;line-height:12pt;font-weight:normal;font-style:normal;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"><font style="font-weight:normal;font-style:normal;text-decoration:none;Background-color:#auto;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"></font><font style="font-size:10pt;font-family:'Times New Roman'">&#8226;</font></p></td>
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<p style="text-align:left;margin-bottom:0pt;margin-top:0pt;line-height:12pt;font-weight:normal;font-style:normal;color:#auto;text-transform:none;font-variant: normal;letter-spacing:0pt;font-family:Cambria;font-size:11pt;"><font style="Background-color:#auto;text-decoration:none;"></font><font style="color:#000000;"></font><font style="font-style:italic;font-size:10pt;font-family:Arial;color:#000000;">the expected impact that generic competition will have on your results of operations and liquidity in future periods,</font></p></td></tr></table></div>
<p style="margin-bottom:0pt;line-height:12pt;margin-top:0pt;margin-left:8.25%;text-indent:-4.12%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;margin-left:12.37%;text-indent:-4.12%;font-weight:bold;font-size:10pt;font-family:Arial;font-style:normal;text-transform:none;font-variant: normal;"><font style="text-decoration:underline;">Company&#8217;s Response:</font></p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;margin-left:12.37%;text-indent:-4.12%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">See note below for the Company&#8217;s response.</p>
<p style="margin-top:0pt;line-height:12pt;margin-bottom:0pt;margin-left:8.25%;text-indent:-4.12%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
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<p style="text-align:left;margin-bottom:0pt;margin-top:0pt;line-height:12pt;font-weight:normal;font-style:normal;color:#auto;text-transform:none;font-variant: normal;letter-spacing:0pt;font-family:Cambria;font-size:11pt;">&nbsp;</p></td>
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<p style="text-align:left;margin-bottom:0pt;margin-top:0pt;line-height:12pt;font-weight:normal;font-style:normal;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"><font style="font-weight:normal;font-style:normal;text-decoration:none;Background-color:#auto;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"></font><font style="font-size:10pt;font-family:'Times New Roman'">&#8226;</font></p></td>
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<p style="text-align:left;margin-bottom:0pt;margin-top:0pt;line-height:12pt;font-weight:normal;font-style:normal;color:#auto;text-transform:none;font-variant: normal;letter-spacing:0pt;font-family:Cambria;font-size:11pt;"><font style="Background-color:#auto;text-decoration:none;"></font><font style="color:#000000;"></font><font style="font-style:italic;font-size:10pt;font-family:Arial;color:#000000;">why you expect growth of net product sales for CINVANTI, despite the generic competition, and</font></p></td></tr></table></div>
<p style="margin-bottom:0pt;line-height:12pt;margin-top:0pt;margin-left:4.12%;text-indent:-4.12%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;margin-left:8.25%;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Arial;font-style:normal;text-transform:none;font-variant: normal;"><font style="text-decoration:underline;">Company&#8217;s Response:</font></p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;margin-left:8.25%;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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.</p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;margin-left:4.12%;text-indent:-4.12%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
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<p style="text-align:left;margin-bottom:0pt;margin-top:0pt;line-height:12pt;font-weight:normal;font-style:normal;color:#auto;text-transform:none;font-variant: normal;letter-spacing:0pt;font-family:Cambria;font-size:11pt;">&nbsp;</p></td>
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<p style="text-align:left;margin-bottom:0pt;margin-top:0pt;line-height:12pt;font-weight:normal;font-style:normal;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"><font style="font-weight:normal;font-style:normal;text-decoration:none;Background-color:#auto;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"></font><font style="font-size:10pt;font-family:'Times New Roman'">&#8226;</font></p></td>
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<p style="text-align:left;margin-bottom:0pt;margin-top:0pt;line-height:12pt;font-weight:normal;font-style:normal;color:#auto;text-transform:none;font-variant: normal;letter-spacing:0pt;font-family:Cambria;font-size:11pt;"><font style="Background-color:#auto;text-decoration:none;"></font><font style="color:#000000;"></font><font style="font-style:italic;font-size:10pt;font-family:Arial;color:#000000;">what effect discounting vs. generic competition had on SUSTOL net product sales.</font></p></td></tr></table></div>
<p style="margin-bottom:0pt;line-height:12pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;margin-left:8.25%;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Arial;font-style:normal;text-transform:none;font-variant: normal;"><font style="text-decoration:underline;">Company&#8217;s Response:</font></p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;margin-left:8.25%;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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.</p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;margin-left:8.25%;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;margin-left:8.25%;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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):</p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;margin-left:8.25%;text-indent:0%;font-family:Times New Roman;font-weight:bold;;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;margin-left:8.25%;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Arial;font-style:normal;text-transform:none;font-variant: normal;">Net Product Sales</p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;margin-left:8.25%;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Net product sales for the three and six months ended June&#160;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&#160;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&#160;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. <font style="font-weight:bold;">CMS reimbursement rates for any buy-and-bill products are based on the Average Selling Price (&#8220;ASP&#8221;) 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 &#8220;generic arbitrage,&#8221; and it can last several quarters. Generic versions of EMEND&#174; 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.</font></p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Arial;font-style:normal;text-transform:none;font-variant: normal;"><font style="text-decoration:underline;"><br /></font></p>
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<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:12pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Arial;font-style:normal;text-transform:none;font-variant: normal;"><font style="text-decoration:underline;">Notes to Consolidated Financial Statements</font></p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Arial;font-style:normal;text-transform:none;font-variant: normal;"><font style="text-decoration:underline;">6. Commitments and Contingencies</font></p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Arial;font-style:normal;text-transform:none;font-variant: normal;"><font style="text-decoration:underline;">Development Agreements, page 96</font></p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;text-indent:0%;font-style:italic;font-size:10pt;font-family:Arial;font-weight:normal;text-transform:none;font-variant: normal;">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:</p>
<p style="margin-top:0pt;line-height:12pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
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<p style="text-align:left;margin-bottom:0pt;margin-top:0pt;line-height:12pt;font-weight:normal;font-style:normal;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"><font style="font-weight:normal;font-style:normal;text-decoration:none;Background-color:#auto;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"></font><font style="font-size:10pt;font-family:'Times New Roman'">&#8226;</font></p></td>
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<p style="text-align:left;margin-bottom:0pt;margin-top:0pt;line-height:12pt;font-weight:normal;font-style:normal;color:#auto;text-transform:none;font-variant: normal;letter-spacing:0pt;font-family:Cambria;font-size:11pt;"><font style="Background-color:#auto;text-decoration:none;"></font><font style="color:#000000;"></font><font style="font-style:italic;font-size:10pt;font-family:Arial;color:#000000;">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.</font></p></td></tr></table></div>
<p style="margin-bottom:0pt;line-height:12pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;margin-left:8.25%;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Arial;font-style:normal;text-transform:none;font-variant: normal;"><font style="text-decoration:underline;">Company&#8217;s Response:</font></p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;margin-left:8.25%;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The $43.9 million does not represent a shortfall of the Company&#8217;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.</p>
<p style="margin-top:0pt;line-height:12pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
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<p style="text-align:left;margin-bottom:0pt;margin-top:0pt;line-height:12pt;font-weight:normal;font-style:normal;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"><font style="font-weight:normal;font-style:normal;text-decoration:none;Background-color:#auto;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"></font><font style="font-size:10pt;font-family:'Times New Roman'">&#8226;</font></p></td>
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<p style="text-align:left;margin-bottom:0pt;margin-top:0pt;line-height:12pt;font-weight:normal;font-style:normal;color:#auto;text-transform:none;font-variant: normal;letter-spacing:0pt;font-family:Cambria;font-size:11pt;"><font style="Background-color:#auto;text-decoration:none;"></font><font style="color:#000000;"></font><font style="font-style:italic;font-size:10pt;font-family:Arial;color:#000000;">Clarify if you continue to have a shortfall in purchase obligations and the status of those minimum purchase obligations at each balance sheet date.</font></p></td></tr></table></div>
<p style="margin-bottom:0pt;line-height:12pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-weight:bold;;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;margin-left:8.25%;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Arial;font-style:normal;text-transform:none;font-variant: normal;"><font style="text-decoration:underline;">Company&#8217;s Response:</font></p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;margin-left:8.25%;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">For the years ended December 31, 2019 and 2020, the Company did not have any shortfalls in its minimum purchase obligations.</p>
<p style="margin-top:0pt;line-height:12pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
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<p style="text-align:left;margin-bottom:0pt;margin-top:0pt;line-height:12pt;font-weight:normal;font-style:normal;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"><font style="font-weight:normal;font-style:normal;text-decoration:none;Background-color:#auto;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"></font><font style="font-size:10pt;font-family:'Times New Roman'">&#8226;</font></p></td>
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<p style="text-align:left;margin-bottom:0pt;margin-top:0pt;line-height:12pt;font-weight:normal;font-style:normal;color:#auto;text-transform:none;font-variant: normal;letter-spacing:0pt;font-family:Cambria;font-size:11pt;"><font style="Background-color:#auto;text-decoration:none;"></font><font style="color:#000000;"></font><font style="font-style:italic;font-size:10pt;font-family:Arial;color:#000000;">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 &#8220;certainty&#8221;.</font></p></td></tr></table></div>
<p style="margin-bottom:0pt;line-height:12pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;margin-left:8.25%;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Arial;font-style:normal;text-transform:none;font-variant: normal;"><font style="text-decoration:underline;">Company&#8217;s Response:</font></p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;margin-left:8.25%;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Regulation S-K Item 303(a)(5) requires broad disclosure of the Company&#8217;s unconditional purchase obligations within the MD&amp;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.</p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;margin-left:8.25%;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><br /></p>
<p style="margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:12pt;">&nbsp;</p>
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<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:12pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:12pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;margin-left:8.25%;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Company acknowledges that information regarding purchase obligations is relevant to investors in understanding our business. In response to the Staff&#8217;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:</p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;margin-left:8.25%;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;margin-left:8.25%;text-indent:0%;color:#000000;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><font style="Background-color:#FFFFFF;">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].</font></p>
<p style="margin-top:0pt;line-height:12pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
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<p style="text-align:left;margin-bottom:0pt;margin-top:0pt;line-height:12pt;font-weight:normal;font-style:normal;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"><font style="font-weight:normal;font-style:normal;text-decoration:none;Background-color:#auto;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"></font><font style="font-size:10pt;font-family:'Times New Roman'">&#8226;</font></p></td>
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<p style="text-align:left;margin-bottom:0pt;margin-top:0pt;line-height:12pt;font-weight:normal;font-style:normal;color:#auto;text-transform:none;font-variant: normal;letter-spacing:0pt;font-family:Cambria;font-size:11pt;"><font style="Background-color:#auto;text-decoration:none;"></font><font style="color:#000000;"></font><font style="font-style:italic;font-size:10pt;font-family:Arial;color:#000000;">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.</font></p></td></tr></table></div>
<p style="margin-bottom:0pt;line-height:12pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;margin-left:8.25%;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Arial;font-style:normal;text-transform:none;font-variant: normal;"><font style="text-decoration:underline;">Company&#8217;s Response:</font></p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;margin-left:8.25%;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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.</p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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.</p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Sincerely,</p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">/s/ Lisa Peraza</p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Lisa Peraza</p>
<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Vice President, Chief Accounting Officer</p>
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<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><font style="font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">cc: </font></p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-family:Arial;font-size:10pt;">David Szekeres, Executive Vice President, Chief Operating Officer</p></td></tr></table></div>
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<p style="margin-bottom:0pt;margin-top:0pt;line-height:12pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-family:Arial;font-size:10pt;">Ryan Murr, Gibson, Dunn &amp; Crutcher LLP</p></td></tr></table></div>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
