10-Q

美國

證券交易委員會

華盛頓特區20549

表格 10-Q


☒		根據1934年證券交易法第13或15（d）條季度報告

截至季度結束日期的財務報告9月30日 2024

或者


☐		根據1934年證券交易法第13或15（d）條的過渡報告

過渡期從______到______

佣金文件號碼: 001-33221

赫龍治療公司，股份有限公司。

(根據其章程規定的註冊人準確名稱)


特拉華（國家或其他管轄區的公司成立或組織）	94-2875566 （IRS僱主唯一識別號碼）

4242 Campus Point Court, 套房200 聖地亞哥, 加利福尼亞州	92121
，（主要行政辦公地址）	(郵政編碼)

註冊人的電話號碼，包括區號： (858) 251-4400

在法案第12(b)條的規定下注冊的證券：


每一類的名稱	交易標誌	在其上註冊的交易所的名稱
普通股，每股面值0.01美元	HRTX	The 納斯達克資本市場資本市場

請在以下方框內劃勾，以表明註冊者 (1)在過去的 12 個月 (或註冊者所需報告的更短期間內)是否已按要求提交了根據 1934 年證券交易法第 13 或第 15(d) 條規定須提交的所有報告；以及 (2) 過去90天是否一直受到這些提交要求的制約。是 ☑ No ☐

請在以下複選框中打勾，指示註冊人是否已經電子提交了根據Regulation S-T規則405條(本章節的§232.405條)需要提交的所有互動數據文件在過去的12個月內(或註冊人被要求提交這些文件的更短期間內)。是 ☑ 沒有 ☐

請勾選標記以說明註冊人是大型快速申報人、加速申報人、非加速申報人、較小的報告公司還是新興成長型公司。請查看《交易所法》第120億.2條中「大型快速申報人」、「加速申報人」、「較小的報告公司」和「新興成長型公司」的定義。


大型加速報告人	☐	加速文件提交人	☑

非加速文件提交人	☐	較小的報告公司	☑

		新興成長公司	☐

如果是新興成長型企業，請勾選複選標記，表明註冊者已選擇不使用延長過渡期來符合根據證券交易法第13(a)條規定提供的任何新財務會計準則。 ☐

請勾選「是」，如果報告人是外殼公司（定義見證券交易法規則12b-2）。是 ☐ 沒有 ☑

截至2024年11月7日，註冊公司普通股的股票數量爲每股面值0.01美元。 152,094,912.

赫龍製藥股份有限公司。

10-Q表格

截至2024年9月30日季度結束


第I部分	財務信息

項目1。	基本報表彙編

	2024年9月30日（未經審計）和2023年12月31日的簡明合併資產負債表	2

	2024年9月30日止三個月和九個月的基本報表和綜合損失（未經審計）	3

	2024年9月30日止三個月和九個月的股東赤字基本報表（未經審計）	4

	2024年9月30日止九個月的已審計簡明綜合現金流量表和2023年（未經審計）	5

	未經審計的簡明合併財務報表註釋	6

ITEm 2.	管理層對財務狀況和經營結果的討論和分析	18

第3項。	市場風險的定量和定性披露	26

第4項。	控制和程序	26

第二部分	其他信息

項目1。	法律訴訟	27

項目1A.	風險因素	28

ITEm 2.	未註冊的股票股權銷售和籌款用途	30

第3項。	對高級證券的違約。	30

第4項。	礦山安全披露	30

第5項	其他信息	30

項目6。	展示資料	31

	簽名	32

第一部分. 財務財務信息

第 1 項。濃縮控制檯合併的財務報表

赫龍治療公司，股份有限公司。

精簡合併資產負債表簡明合併資產負債表

(以千爲單位)


	9月30日 2024			十二月三十一日， 2023
	(未經審計)			(見注2)
資產
流動資產：
現金及現金等價物	$	25,741		$	28,677
短期投資		45,149			51,732
應收賬款淨額		67,039			60,137
庫存		45,950			42,110
預付款項及其他流動資產		11,308			6,118
總流動資產		195,187			188,774
資產和設備，淨值		15,414			20,166
租賃權益資產		3,469			5,438
其他		6,707			8,128
總資產	$	220,777		$	222,506
負債和股東赤字
流動負債:
應付賬款	$	10,188		$	3,240
應計臨床和製造業責任		22,859			22,291
應計工資和員工責任		8,531			9,224
其他應計負債		40,717			41,855
Non-underlying items		3,249			3,075
流動負債合計		85,544			79,685
非流動租賃負債		522			2,800
非流動應付票據淨額		24,828			24,263
非流動可轉換應付票據淨額		149,647			149,490
其他非流動負債		241			241
負債合計		260,782			256,479
股東赤字：
		1,517			1,503
額外實收資本		1,881,695			1,870,525
累計其他綜合收益		40			13
累積赤字		(1,923,257	)		(1,906,014	)
股東赤字總額		(40,005	)		(33,973	)
負債總額和股東權益虧損總額	$	220,777		$	222,506

詳見附註。

赫龍治療公司，股份有限公司。

經過簡化的綜合損益表（未經審核）運營和綜合虧損

（未經審計）

（以千爲單位，除每股金額外）


	截至9月30日的三個月						截至9月30日的九個月
	2024			2023			2024			2023
營收：
產品淨銷售額	$	32,810		$	31,434		$	103,504		$	92,811
產品銷售成本		9,458			18,208			28,420			55,220
毛利潤		23,352			13,226			75,084			37,591
營業費用：
研發費用		4,465			9,285			13,505			31,331
一般行政		12,373			15,914			41,252			51,340
銷售及營銷費用		10,972			12,956			36,028			55,315
總營業費用		27,810			38,155			90,785			137,986
經營虧損		(4,458	)		(24,929	)		(15,701	)		(100,395	)
其他（費用）收益，淨額		(390	)		(79	)		(1,542	)		560
淨利潤		(4,848	)		(25,008	)		(17,243	)		(99,835	)
其他綜合收益:
短期投資的未實現收益		48			5			27			18
綜合損失	$	(4,800	)	$	(25,003	)	$	(17,216	)	$	(99,817	)
每股普通股基本和稀釋淨虧損	$	(0.03	)	$	(0.17	)	$	(0.11	)	$	(0.75	)
普通股基本和稀釋平均股數		152,830			144,990			152,213			133,747

詳見附註。

赫龍治療公司，股份有限公司。

壓縮合並財務報表股東赤字的說明

(未經審計)

(以千爲單位)


	普通股
	股份		金額		股本所對應的賬面超額支付資本		其他綜合收益累積額收益（損失）			累積赤字			總股東權益（虧損）
2023年12月31日的餘額		150,285	$	1,503	$	1,870,525	$	13		$	(1,906,014	)	$	(33,973	)
按股權激勵計劃發行普通股		93		1		10		—			—			11
Stock-based compensation expense		—		—		3,375		—			—			3,375
淨利潤		—		—		—		—			(3,160	)		(3,160	)
短期投資的淨未實現損失		—		—		—		(19	)		—			(19	)
綜合損失														(3,179	)
2024年3月31日餘額（未經審計）		150,378		1,504		1,873,910		(6	)		(1,909,174	)		(33,766	)
按股權激勵計劃發行普通股		872		9		309		—			—			318
根據員工股票購買計劃發行普通股		328		3		172		—			—			175
Stock-based compensation expense		—		—		4,570		—			—			4,570
淨利潤		—		—		—		—			(9,235	)		(9,235	)
短期投資的淨未實現損失		—		—		—		(2	)		—			(2	)
綜合損失														(9,237	)
截至2024年6月30日的資金餘額（未經審計）		151,578		1,516		1,878,961		(8	)		(1,918,409	)		(37,940	)
按股權激勵計劃發行普通股		124		1		12		—			—			13
Stock-based compensation expense		—		—		2,722		—			—			2,722
淨利潤		—		—		—		—			(4,848	)		(4,848	)
短期投資的未實現淨收益		—		—		—		48			—			48
綜合損失														(4,800	)
截至2024年9月30日的餘額（未經審計）		151,702	$	1,517	$	1,881,695	$	40		$	(1,923,257	)	$	(40,005	)


	普通股
	股份		金額		股本所對應的賬面超額支付資本			其他積累綜合虧損			累計赤字			總股東權益（虧損）
2022年12月31日餘額		119,155	$	1,191	$	1,807,855		$	(19	)	$	(1,795,455	)	$	13,572
按股權激勵計劃發行普通股		125		2		(210	)		—			—			(208	)
Stock-based compensation expense		—		—		7,947			—			—			7,947
淨利潤		—		—		—			—			(32,768	)		(32,768	)
開空投資的未實現利潤		—		—		—			28			—			28
綜合損失															(32,740	)
截至2023年3月31日的餘額（未經審計）		119,280		1,193		1,815,592			9			(1,828,223	)		(11,429	)
按股權激勵計劃發行普通股		330		3		(388	)		—			—			(385	)
根據員工股票購買計劃發行普通股		346		3		701			—			—			704
Stock-based compensation expense		—		—		13,900			—			—			13,900
淨利潤		—		—		—			—			(42,059	)		(42,059	)
投資中的未實現淨虧損		—		—		—			(15	)		—			(15	)
綜合損失															(42,074	)
2023年6月30日的結餘 (未經審計)		119,956		1,199		1,829,805			(6	)		(1,870,282	)		(39,284	)
按股權激勵計劃發行普通股		410		4		(312	)		—			—			(308	)
定向增發普通股		20,735		208		29,547			—			—			29,755
債務融資中的認購權證發行		—		—		371			—			—			371
Stock-based compensation expense		—		—		6,683			—			—			6,683
淨利潤		—		—		—			—			(25,008	)		(25,008	)
短期投資的淨未實現損失		—		—		—			5			—			5
綜合損失															(25,003	)
2023年9月30日的餘額（未經審計）		141,101	$	1,411	$	1,866,094		$	(1	)	$	(1,895,290	)	$	(27,786	)

詳見附註。

赫龍治療公司，股份有限公司。

壓縮的合併現金流量表現金流量表

(未經審計)

(以千爲單位)


	截至九個月 9月30日,
	2024			2023
經營活動：
淨虧損	$	(17,243	)	$	(99,835	)
調整爲淨損失到經營活動現金流量淨使用：
基於股票的薪酬費用		10,667			28,530
折舊和攤銷		1,911			2,184
債務折扣攤銷		504			21
債務發行成本的攤銷		157			155
短期投資折現率增值		(1,754	)		(1,173	)
財產和設備的減值		4,269			463
處置固定資產和設備的損失		—			23
經營性資產和負債的變化：
應收賬款		(6,902	)		(11,746	)
存貨		(3,840	)		12,566
預付款和其他資產		(3,769	)		10,541
應付賬款		6,948			(1,365	)
應計臨床和製造業責任		208			272
應計工資和員工責任		(693	)		(3,040	)
其他應計及其他非流動負債		(1,212	)		1,160
用於經營活動的淨現金		(10,749	)		(61,244	)
投資活動：
購買期權		(90,745	)		(64,309	)
短期投資到期或銷售所得		99,109			92,435
購買物業和設備		(1,068	)		(1,295	)
投資活動提供的淨現金流量		7,296			26,831
籌資活動：
定向增發的淨收益		—			29,755
票據融資的淨收益		—			24,350
根據股權激勵計劃發行股票的收款（付款）		342			(901	)
員工股票購買計劃下的購買收益		175			704
融資活動提供的淨現金		517			53,908
現金及現金等價物淨增加額（減少額）		(2,936	)		19,495
年初現金及現金等價物		28,677			15,364
期末現金及現金等價物	$	25,741		$	34,859
現金流信息的補充披露：
支付的利息	$	3,088		$	1,288

見附註。

赫龍治療公司，股份有限公司。

簡明合併財務報表附註合併財務報表註記

(未經審計)

在這份關於表格10-Q的季度報告中，所有對「Heron」，「公司」，「我們」，「我們」和類似術語的引用均指向heron therapeutics公司及其全資子公司heron therapeutics b.V. heron therapeutics®，heron標誌，ZYNRELEF®，APONVIE®，CINVANTI®，SUSTOL®，以及Biochronomer® 爲我們的商標。所有其他商標出現在或通過參考本季度10-Q表格的都歸其各自所有者所有。

1. 業務

我們是一家商業階段的生物技術公司，專注於通過開發和商業化治療創新來改善患者的生活，提升醫療保健水平。我們先進的科學、專利技術以及對藥物發現和開發的創新方法，使我們能夠創建並商業化一系列旨在提升急救和腫瘤患者護理標準的產品。

ZYNRELEF（布比卡因和美洛昔康）長效溶液（"ZYNRELEF"）在美國獲批用於術後疼痛管理。APONVIE（阿普利知）注射乳劑（"APONVIE"）在美國獲批用於預防術後噁心和嘔吐。CINVANTI（阿普利知）注射乳劑（"CINVANTI"）和SUSTOL（格拉司瓊）長效注射劑（"SUSTOL"）均在美國獲批用於預防化療引起的噁心和嘔吐。

截至2024年9月30日我們擁有現金、現金等價物和短期投資，總額爲 $70.9 百萬。根據我們當前的運營計劃和預測，管理層認爲公司的現金、現金等價物和短期投資將足以滿足公司在本季度報告Form 10-Q提交給美國證券交易委員會（"SEC"）之日起至少一年內的預期現金需求。

2. 呈現基礎

附帶的簡要合併基本報表依據美國通用會計準則（「GAAP」）爲臨時財務信息和美國證券交易委員會（SEC）對臨時報告的要求編制。因此，由於這些是臨時報表，它們不包括GAAP對完整基本報表所要求的所有信息和披露。管理層認爲，所有爲了公正呈現而考慮的必要調整（包括正常的經常性應計項）均已包含在內。截至2024年9月30日的三個月和九個月的運營結果不一定能指示2024年12月31日結束的其他季度或整年的結果。2023年12月31日的簡要合併資產負債表是從該日期的經過審計的基本報表中提取的。有關更完整的財務信息，這些簡要合併基本報表及其附註應與我們截至2023年12月31日的年度報告10-K中包含的經過審計的基本報表一起閱讀。，該文件於2024年3月12日提交給SEC。

某些費用的重新分類s

截至2023年9月30日的三個月和九個月的簡要合併運營和綜合虧損報表反映了某些費用從研發費用重新分類爲一般和行政費用，以與公司截至2024年9月30日的展示保持一致。由於2023年實施的重組及公司部門的重新調整，這些重新分類對總營業費用、運營虧損或淨虧損沒有變化，且不需要提供臨時財務信息。

3. 會計政策

合併原則

附帶的簡明合併基本報表包括heron therapeutics, Inc.及其全資子公司heron therapeutics b.V.，後者於2015年3月在荷蘭成立。heron therapeutics b.V.沒有運營，也沒有重要的資產或負債，自成立以來與heron therapeutics b.V.的重大交易也沒有發生。

使用估計

按照GAAP編制基本報表要求管理層做出估計和假設，這些估計和假設會影響財務報表中報告的金額以及附帶財務報表說明中的披露。我們涉及重大判斷和估計的主要會計政策包括營業收入確認、投資、庫存及相關準備、應計臨床負債、所得稅及基於股票的補償。實際結果可能與這些估計存在實質性差異。

現金、現金等價物及短期投資

現金及現金等價物由現金和從原始購買日期起合同到期在三個月或更短的高流動性投資組成.

短期投資由合同到期在原始購買日期超過三個月的證券組成。合同到期超過一年的證券在簡明合併資產負債表中被歸類爲短期投資，因爲我們有能力在必要時變現這些證券以滿足我們接下來的12個月的流動性需求。我們已將我們的短期投資歸類爲附帶的簡明合併基本報表中的可供出售證券。可供出售證券按公允市場價值列示，未實現的收益和損失的淨變化在其他綜合收入（損失）中報告，已實現的收益和損失在其他收入（費用）中包含，淨額計算。出售證券的成本基於特定識別方法。對被分類爲可供出售的證券的利息和分紅派息被納入其他收入（費用）的利息收入中，淨額計算。

我們的銀行和投資帳戶已根據我們的營運資金融資協議（見附註8）簽訂了控制協議。

信貸風險集中

現金、現金等價物和短期投資是可能使我們面臨信用風險集中情況的金融工具。我們將現金存入金融機構。有時，這些存款可能超過受保限額。我們在這些帳戶中沒有經歷任何損失，並相信我們沒有面臨與現金、現金等價物和短期投資相關的重大風險。然而，任何損失或無法訪問這些資金可能會對公司的財務控件、經營成果和現金流產生重大不利影響。

我們還可能將多餘的現金投資於貨幣市場基金、美國政府及其機構、企業債務證券和商業票據。我們已建立關於現金投資的多樣化和到期的指導方針，以努力維持安全性和流動性。這些指導方針會定期審核和修改，以利用收益和利率的趨勢。

ZYNRELEF、APONVIE、CINVANTI和SUSTOL（統稱爲我們的「產品」）通過少數專業分銷商和全線批發商（統稱爲「客戶」）在美國銷售，這些客戶將其轉售給醫療保健提供者和醫院，即我們的產品的最終用戶。

以下表格包括我們三位主要客戶的淨產品銷售和應收賬款餘額的百分比，每位客戶的產品銷售佔比均爲10%或以上：


	產品淨銷售額						賬目應收款
	截至三個月 2024年9月30日			截至九個月 2024年9月30日			截至 2024年9月30日
客戶A		43.4	%		44.5	%		41.4	%
客戶B		35.0	%		35.8	%		36.3	%
客戶C		20.2	%		18.5	%		22.0	%
總計		98.6	%		98.8	%		99.7	%

A應收賬款，淨額

應收賬款按發票金額入賬，扣除信用損失準備金。信用損失準備金反映了被認爲無法收回的應收賬款餘額。截止至2024年9月30日截至2023年12月31日，我們沒有沒有信貸損失的準備金。在估計信貸損失準備金時，我們考慮（1）我們與收款和沖銷的歷史經驗；（2）我們客戶的信用質量及其最近或預計的變化；（3）我們客戶的未償餘額和逾期金額；以及（4）合理且可支持的經濟狀況預測，預計在應收款項的合同期限內存在。

I存貨

存貨以成本或估計可實現淨值中的較低者列示，採用先進先出法（FIFO）。我們定期分析存貨水平，並對已過時的存貨、成本超過其估計可實現價值的存貨以及超過預期銷售需求的存貨數量進行減值。判斷存貨成本是否可實現需要管理層的估計。如果實際市場條件不如管理層預計的那麼有利，可能需要額外減值存貨，這將記入產品銷售成本。

房地產和設備，N等。

房地產和設備按成本減去累計折舊和攤銷列示。折舊按資產的預計使用壽命進行直線計算（通常 5年). 租賃改善以成本計量，並在資產的估計使用壽命或租賃期的較短者上按直線法攤銷。在 2024年9月30日結束的三個和九個月內，分別爲，我們在財產和設備的註銷中發生了$0.8 百萬美元和美元4.3 百萬，分別。在2024年第一季度確認的 1百萬美元收入中，我們確認了來自以前期間滿足或部分滿足的義務的1百萬美元收入，其中2百萬美元是由於變量計費安排下我們的可變補償估計發生變化，1百萬美元是由於客戶和未開票服務應收款準備的釋放。2023年第一季度確認的百萬美元中，我們確認了百萬美元的收入。4.3 百萬的損失，截止到2024年9月30日的九個月，$2.5 百萬被記錄爲其他（費用）收入，淨額，其餘的損失被記錄爲營業費用。

L減輕

我們在合同開始時判斷安排是否爲租賃或包含租賃元件。初始期限超過 12 個月的經營租賃在簡明合併資產負債表上記錄爲租賃負債和相應的使用權（「ROU」）租賃資產。ROU 租賃資產代表我們在租賃期間對基礎資產的使用權，租賃負債代表我們因租賃而產生的租賃付款的現值。租賃負債在租賃開始時根據租賃期限內租賃付款的現值確認。由於我們的大多數租賃未提供隱含利率，我們在判斷租賃付款的現值時，使用基於合同開始日期可獲得信息的增量借款利率。當隱含利率易於確定時，我們使用隱含利率。ROU 租賃資產等於租賃負債減去未攤銷的租賃激勵、未攤銷的初始直接成本以及租賃費用和租賃支付金額之間的累計差額。租賃期限包括任何選擇權，以延長或終止租賃，當我們合理確定將行使該選擇權時。租賃費用在租賃期間按直線法確認。我們選擇了實務簡化，不分離租賃和非租賃元件。

營業收入收入確認

根據財務會計準則委員會（「FASB」）會計準則彙編（「ASC」）第 606 章確認收入，與客戶的合同收入（「第 606 章」）。第 606 章基於收入應該

被確認爲描繪已向客戶轉讓承諾的貨物或服務的數量，反映實體期望因交換而有權獲得的對價。

產品銷售

我們的產品通過有限數量的客戶在美國分銷給醫療服務提供商和醫院，即我們產品的最終用戶。

營業收入的確認金額反映了我們期望因交換我們產品而收到的對價。爲了確定適用於第606號課題範圍內的與客戶合同的營業收入確認，我們執行以下五個步驟：（i）確定與客戶的合同；（ii）確定合同的履約義務；（iii）確定交易價格；（iv）將交易價格分配給合同中的履約義務；和（v）在履行履約義務時認可收入。我們從產品銷售中確認營業收入，當產品控制轉移給我們的客戶時。我們通常根據產品何時交付和所有權何時轉移給我們的客戶來確定控制轉移。

產品銷售折讓

我們將產品銷售折讓確認爲相關收入確認期間產品銷售的減少。產品銷售折讓基於應收金額或將要申請的相關銷售。這種可變考慮因素包括考慮與客戶協議條款，歷史產品退貨，折扣或已提取的回扣，產品的保質期和特定已知市場事件（例如競爭定價和新產品推介）的估計。如果實際未來結果與我們的估計不符，我們可能需要調整這些估計，這可能會影響產品銷售和盈利。我們的產品銷售折讓包括：

•

產品退貨—我們允許大多數客戶在產品到期日三個月前開始退貨以獲取信用，直至產品到期日後12個月。因此，從產品發貨到退貨產品發放信用之間可能會有相當長的時間。

•

我們根據合同中固定的批發收購成本和數據費用的百分比支付分銷服務費用給我們的客戶。這些費用最遲在產品發貨的季度之後的兩個月內支付。

•

集團採購組織（"GPO"）折扣和回扣—我們向GPO成員提供現金折扣。這些折扣是在GPO成員從我們的客戶購買產品時提供的，然後我們向我們收回折扣金額。此外，我們向GPO成員提供成交量和合同階梯回扣。回扣基於季度回扣購買期間的實際購買水平。

•

GPO行政費用—我們支付給GPO的行政費用是基於合同條款的，並且在GPO成員購買產品的季度之後支付。

•

醫療補貼—我們參與醫療補貼計劃，根據每個州對資格和服務的指導方針，爲某些低收入患者提供幫助。在醫療補貼計劃下，我們向每個參與州支付補貼，通常是在產品售出的季度之後的六個月內。

•

即時支付折扣—我們可能根據合同條款爲我們的客戶提供產品銷售折扣以獲得及時付款。

我們認爲對產品退貨和GPO折扣的估計津貼需要高度判斷，並且根據我們的經驗和某些定量和定性因素而變化。我們認爲我們對分銷費用、GPO回扣和行政費用、醫療補貼和即時支付折扣的估計津貼不需要高度判斷，因爲這些金額在相對較短的時間內就會解決。

我們的產品銷售津貼和相關應收款項在每個報告期進行評估，並在趨勢或重大事件表明需要更改估計時進行調整。產品銷售津貼估計變動可能會對我們的經營業績和財務狀況產生重大影響。

下表提供了分解後的淨產品銷售額（單位：千元）：


	截至三個月 9月30日,				截至九個月 9月30日,
	2024		2023		2024		2023
CINVANTI淨產品銷售額	$	22,662	$	23,270	$	73,205	$	70,599
SUSTOL淨產品銷售額		2,763		3,439		10,623		9,258
ZYNRELEF淨產品銷售額		6,245		4,372		17,089		12,033
APONVIE淨產品銷售		1,140		353		2,587		921
總淨產品銷售額	$	32,810	$	31,434	$	103,504	$	92,811

以下表格提供了關於我們的產品退貨、分銷商費用和折扣、退款及行政費用的活動總結，這些費用包括在簡明合併資產負債表中其他應計負債項目（以千計）：


	產品懷舊口味"橙子片"回歸			所有板塊在市場開放時進行費用			折扣, 回扣行政費用			總計
2023年12月31日餘額	$	4,776		$	4,419		$	27,334		$	36,529
準備金		(750	)		21,314			150,281			170,845
付款/信用額		(638	)		(20,261	)		(151,592	)		(172,491	)
2024年9月30日的結餘	$	3,388		$	5,472		$	26,023		$	34,883

鈷綜合收益（損失）

綜合收益（損失）被定義爲在一個期間內，非所有者來源的交易和其他事件及情況導致的股權變動。未實現的可出售證券的淨收益和損失的變動包含在其他綜合收益（損失）中，代表我們的淨損失與所有呈現期間的綜合損失之間的差異。

淨利潤每股損失

基本每股淨損失是通過將淨損失除以期間內已發行的每股普通股加權平均數來計算的，包括用於購買普通股的預融資warrants。稀釋後的每股淨損失是通過將淨損失除以期間內的普通股和普通股等值的加權平均數來計算的，該計算方法使用的是庫藏股法。根據此計算，期權、限制性股票單位、warrants和可轉換票據下的普通股被視爲普通股等值，僅在其影響爲稀釋性時才包括在稀釋後的每股淨損失計算中。

由於我們在未經審計的簡明合併運營和綜合損失報表中所有呈現期間均發生了淨損失，以下普通股等值未被納入每股淨損失的計算，因爲其效果爲反稀釋（以千爲單位）：


	9月30日,
	2024		2023
未行權股票期權		26,156		31,317
未行權的受限股票單位		1,547		1,786
未行權的認股權證		298		298
可轉換票據所對應的普通股股份		9,819		9,819

收回最近的會計公告

不時會有新的會計公告由FASB或其他標準制定機構發佈，我們會在指定的生效日期採納。我們已經評估了最近發佈的會計公告，並且沒有不認爲它們會對我們的簡明合併基本報表或相關的基本報表披露產生重大影響。

在2023年11月，FASB發佈了ASU 2023-07，分部報告（主題280）：可報告分部披露的改進（"ASU 2023-07"），該標準通過要求披露重大分部費用來加強分部披露。

ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and interim periods beginning after December 15, 2024. Retrospective application is required. We are currently evaluating the impact on our disclosures.

In December 2023, the FASB issued Accounting Standards Update ("ASU") No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures ("ASU 2023-09"), to enhance income tax reporting disclosures and require disclosure of specific categories in the tabular rate reconciliation. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, on a prospective basis. Early adoption and retrospective application are permitted. We are currently evaluating the impact on our disclosures.

4. Fair Value Measurements

Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The FASB ASC Topic 820, Fair Value Measurements and Disclosures, establishes a fair value hierarchy which prioritizes the inputs used in measuring fair value as follows:

•

Level 1—Observable inputs such as quoted prices in active markets for identical assets or liabilities.

•

Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

•

Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

We measure cash, cash equivalents and short-term investments at fair value on a recurring basis. The fair values of such assets were as follows (in thousands):


			Fair Value Measurements at Reporting Date Using
	Balance at September 30, 2024		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Cash and money market funds	$	22,678	$	22,678	$	—	$	—
U.S. Treasury bills and government agency obligations		24,734		24,734		—		—
U.S. corporate debt securities		9,439		—		9,439		—
Foreign corporate debt securities		9,077		—		9,077		—
Foreign commercial paper		3,970		—		3,970		—
U.S. commercial paper		992		—		992		—
Total	$	70,890	$	47,412	$	23,478	$	—


			Fair Value Measurements at Reporting Date Using
	Balance at December 31, 2023		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Cash and money market funds	$	23,441	$	23,441	$	—	$	—
U.S. Treasury bills and government agency obligations		31,636		31,636		—		—
U.S. corporate debt securities		16,889		—		16,889		—
Foreign corporate debt securities		5,460		—		5,460		—
U.S. commercial paper		1,990		—		1,990		—
Foreign commercial paper		993		—		993		—
Total	$	80,409	$	55,077	$	25,332	$	—

We have not transferred any investment securities between the three levels of the fair value hierarchy for the three and nine months ended September 30, 2024, and 2023.

As of September 30, 2024, cash equivalents included $11.5 million of available-for-sale securities with contractual maturities of three months or less and short-term investments included $22.1 million of available-for-sale securities with contractual maturities of three months to one year. As of December 31, 2023, cash equivalents included $5.3 million of available-for-sale securities with contractual maturities of three months or less and short-term investments included $51.7 million of available-for-sale securities with contractual maturities of three months to one year. The money market funds as of September 30, 2024, and December 31, 2023 are included in cash and cash equivalents on the condensed consolidated balance sheets.

A company may elect to use fair value to measure accounts receivable, available-for-sale securities, accounts payable, guarantees and issued debt, among others. If the use of fair value is elected, any upfront costs and fees related to the item such as debt issuance costs must be recognized in earnings and cannot be deferred. The fair value election is irrevocable and generally made on an instrument-by-instrument basis, even if a company has similar instruments that it elects not to measure based on fair value. Unrealized gains and losses on existing items for which fair value has been elected are reported as a cumulative adjustment to beginning retained earnings and any changes in fair value are recognized in earnings. We have elected to not apply the fair value option to our financial assets and liabilities.

Financial instruments, including cash, cash equivalents, receivables, inventory, prepaid expenses, other current assets, accounts payable and accrued expenses are carried at cost, which is considered to be representative of their respective fair values because of the short-term maturity of these instruments. Short-term available-for-sale investments are carried at fair value. Our notes payable and convertible notes payable outstanding at September 30, 2024 and December 31, 2023 do not have a readily available ascertainable market value; however, their carrying value, which is measured at carrying value less unamortized debt issuance costs and debt discounts, is considered to approximate their fair value.

5. Short-Term Investments

The following is a summary of our short-term investments (in thousands):


	September 30, 2024
			Gross		Gross
	Amortized		Unrealized		Unrealized		Estimated
	Cost		Gains		Losses		Fair Value
U.S. Treasury bills and government agency obligations	$	23,218	$	22	$	—	$	23,240
U.S. corporate debt securities		8,611		9		—		8,620
Foreign corporate debt securities		8,321		6		—		8,327
Foreign commercial paper		3,967		3		—		3,970
U.S. commercial paper		992		—		—		992
Total	$	45,109	$	40	$	—	$	45,149


	December 31, 2023
			Gross		Gross
	Amortized		Unrealized		Unrealized			Estimated
	Cost		Gains		Losses			Fair Value
U.S. Treasury bills and government agency obligations	$	31,625	$	11	$	—		$	31,636
U.S. corporate debt securities		11,652		1		—			11,653
Foreign corporate debt securities		5,459		1		—			5,460
U.S. commercial paper		1,991		—		(1	)		1,990
Foreign commercial paper		993		—		—			993
Total	$	51,720	$	13	$	(1	)	$	51,732

The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. We regularly monitor and evaluate the realizable value of our marketable securities. We did not recognize any impairment losses during the three and nine months ended September 30, 2024, and 2023.

Unrealized gains and losses associated with our investments are reported in accumulated other comprehensive income (loss). Realized gains and losses associated with our investments, if any, are reported in the statements of operations and comprehensive loss. We did not recognize any realized gains or losses during the three and nine months ended September 30, 2024, and 2023.

6. Inventory

Inventory consists of the following (in thousands):


	September 30, 2024		December 31, 2023
Raw materials	$	20,821	$	17,643
Work in process		18,352		14,550
Finished goods		6,777		9,917
Total inventory	$	45,950	$	42,110

As of September 30, 2024, total inventory included $30.6 million related to CINVANTI, $11.1 million related to ZYNRELEF, $3.4 million related to SUSTOL and $0.8 million related to APONVIE. As of December 31, 2023, total inventory included $26.4 million related to CINVANTI, $11.2 million related to ZYNRELEF, $4.1 million related to SUSTOL and $0.4 million for APONVIE. For the three and nine months ended September 30, 2024, cost of product sales included charges of $0.8 million and $2.4 million relating to reserves and write-offs of inventory. For the three and nine months ended September 30, 2023, cost of product sales included charges of $7.5 million and $20.3 million, respectively, relating to the write-off of inventory.

7. Leases

As of September 30, 2024, we had an operating lease for 52,148 square feet of laboratory and office space in San Diego, California, with a lease term that expires on December 31, 2025. In October 2021, we entered into a sublease agreement to sublet 23,873 square feet of laboratory and office space. The space was delivered to the subtenant in March 2022. As a result of the sublease agreement, our one five-year option to renew this lease on expiration applies only with respect to our remaining 28,275 square feet of laboratory and office space.

We have an operating lease through which we sublease 5,840 square feet of office space in Cary, North Carolina, with a lease term that expires on April 30, 2025.

During the three and nine months ended September 30, 2024, we recognized $0.7 million and $2.2 million of operating lease expense, respectively. During the three and nine months ended September 30, 2024, we paid $0.8 million and $2.4 million, respectively, for our operating leases.

During the three and nine months ended September 30, 2023, we recognized $0.7 million and $2.1 million of operating lease expense, respectively. During the three and nine months ended September 30, 2023, we paid $0.5 million and $2.2 million, respectively, for our operating leases.

Annual future minimum lease payments as of September 30, 2024, are as follows (in thousands):


2024		793
2025		3,138
Total future minimum lease payments	$	3,931
Less: discount		(160	)
Total lease liabilities	$	3,771

8. Long-Term Debt and Convertible Notes

Working Capital Facility Agreement

On August 9, 2023, we entered into a working capital facility agreement (the “Loan Agreement”) with Hercules Capital, Inc., as administrative agent and collateral agent, and the lenders party thereto (the “Lenders”). The Loan Agreement provides an aggregate principal amount of up to $50.0 million with tranched availability as follows: $25.0 million at closing (“tranche 1A”), $5.0 million available through December 15, 2024 (“tranche 1B”), and $20.0 million available from the earlier of: (1) the full draw of tranche 1B and (2) the expiration of tranche 1B, and available through December 15, 2025 (“tranche 1C”), and in the case of tranches 1B and 1C, subject to certain customary conditions to draw down.

The Loan Agreement has a term of four years, with a springing maturity date that is 91 days prior to the stated maturity of our Notes (as defined below) (if still outstanding at such time). The loans thereunder do not have any scheduled amortization payments and accrue interest at a floating rate equal to, 9.95% per annum, payable in cash on a monthly basis and upon maturity or payoff. In addition, under the terms of the Loan Agreement, the loans also accrue paid-in-kind interest at a fixed-rate of 1.5% per annum which is due upon maturity or payoff.

In addition, in connection with the tranche 1A funding, we issued warrants to the Lenders to purchase up to 297,619 shares of our common stock at an exercise price of $1.68 per share (the "Lender Warrants"). The Lender Warrants are equal to 2.00% of the principal amount of tranche 1A loans funded by the Lenders (the “Warrant Coverage”). The Loan Agreement also requires that we issue additional warrants to the Lenders at the time of each draw down of tranches 1B and 1C with the same Warrant Coverage. Each Lender Warrant is exercisable for seven years from the date of issuance.

The Loan Agreement contains a minimum cash covenant, beginning on the closing date, requiring us to hold cash of no less than $8.5 million, if our market capitalization is less than $400.0 million. The Loan Agreement also contains customary representations and warranties and customary affirmative and negative covenants, including, among other things, restrictions on indebtedness, liens, investments, mergers, dispositions, prepayment of other indebtedness, and dividends and other distributions, subject to certain exceptions. We were in compliance with all covenants of the Loan Agreement as of September 30, 2024.

The Loan Agreement was accounted for in accordance with ASC Topic 470, Debt, ASC Topic 480, Distinguishing Liabilities from Equity, and ASC Topic 815, Derivatives and Hedging. The initial tranche 1A funding of $25.0 million and the Lender Warrants are accounted for as freestanding debt and equity financial instruments, respectively, as they are legally detachable and separately exercisable. The additional borrowings available under the Loan Agreement plus the additional warrants to purchase shares of our common stock, which would be issued concurrently, are accounted for as a single freestanding financial instrument that are not assets or obligations of ours; this financial instrument meets the loan commitment derivative scope exception and will be accounted for when and if we borrow additional tranches in the future. The initial funding of $25.0 million was recorded as a liability on the condensed consolidated balance sheets.

In connection with the Loan Agreement, we recognized the initial Lender Warrants at their relative fair value of $0.4 million, and we incurred debt issuance costs of $0.6 million, both of which were recorded as debt discounts. The debt discounts and the end of term fee, of $0.8 million, are being amortized and accreted into interest expense using the effective interest rate method over the term of the Loan Agreement, resulting in an effective interest rate of 14.5%. For the three and nine months ended September 30, 2024, interest expense related to the Loan Agreement was $0.9 million and $2.7 million, respectively, which included $0.6 million and $1.9 million, respectively, related to the stated interest rate, $0.1 million and $0.3 million, respectively, related to paid-in-kind interest, and $0.2 million and $0.5 million, respectively, related to the amortization of the debt discounts and accretion of the end of term fee. For the three and nine months ended September 30, 2023, interest expense related to the Loan Agreement was $0.5 million, which included $0.4 million related to the stated interest rate, and $0.1 million related to paid-in-kind interest.

As of September 30, 2024, the carrying value of tranche 1A was $24.8 million, which is comprised of the $25.0 million principal amount outstanding, $0.4 million of accumulated paid-in-kind interest, less debt discounts of $0.6 million. The end of term fee accreted as of September 30, 2024, of $0.3 million is recorded in other accrued liabilities on the condensed consolidated balance sheets.

Senior Unsecured Convertible Notes

In May 2021, we entered into a note purchase agreement with funds affiliated with Baker Bros. Advisors LP for a private placement of $150.0 million in Senior Unsecured Convertible Notes (the “Notes”). We received a total of $149.0 million, net of issuance costs, from the issuance of the Notes.

The Notes were issued at par. The Notes bear interest at a rate of 1.5% per annum, payable in cash semi-annually in arrears on June 15 and December 15 of each year, beginning on December 15, 2021. The Notes mature on May 26, 2026, unless earlier converted, redeemed or repurchased.

The Notes are subject to redemption at our option, between May 24, 2024 and May 24, 2025, but only if the last reported sale price per share of our common stock exceeds 250% of the conversion price for a specified period of time, or will be subject to redemption at our option on or after May 24, 2025 if the last reported sale price per share of our common stock exceeds 200% of the conversion price for a specified period of time. The redemption price will be equal to the principal amount of the Notes to be redeemed, plus accrued and unpaid interest.

Upon conversion, we will settle the Notes in shares of our common stock. The initial conversion rate for the Notes is 65.4620 shares per $1,000 principal amount of the Notes (equivalent to an initial conversion price of $15.276 per share of common stock).

If a holder of the Notes converts upon a make-whole fundamental change or company redemption, the holder may be eligible to receive a make-whole premium through an increase to the conversion rate.

In May 2021, we filed a registration statement with the SEC to register for resale 12.4 million shares of our common stock underlying the Notes, including the maximum number of shares of common stock issuable under the make-whole premium.

The Notes were accounted for in accordance with ASC Subtopic 470-20, Debt with Conversion and Other Options (“ASC 470-20”), and ASC Subtopic 815-40, Contracts in Entity’s Own Equity (“ASC 815-40”). Under ASC 815-40, to qualify for equity classification (or non-bifurcation, if embedded), the instrument (or embedded feature) must be both (1) indexed to the issuer’s stock and (2) meet the requirements of the equity classification guidance. Based upon our analysis, it was determined that the Notes do contain embedded features indexed to our common stock, but do not meet the requirements for bifurcation, and therefore do not need to be separately accounted for as an equity component. Since the embedded conversion feature meets the equity scope exception from derivative accounting, and, also since the embedded conversion option does not need to be separately accounted for as an equity component under ASC 470-20, the proceeds received from the issuance of the Notes were recorded as a liability on the condensed consolidated balance sheets.

We incurred issuance costs related to the Notes of $1.0 million, which we recorded as debt issuance costs and are included as a reduction to the Notes on the condensed consolidated balance sheets. The debt issuance costs are being amortized to interest expense using the effective interest rate method over the term of the Notes, resulting in an effective interest rate of 1.6%. For the three and nine months ended September 30, 2024, interest expense related to the Notes was $0.6 million and $1.8 million, respectively, which included $0.5 million and $1.6 million, respectively, related to the stated interest rate and $0.1 million and $0.2 million, respectively, related to the amortization of debt issuance costs. For the three and nine months ended September 30, 2023, interest expense related to the Notes was $0.6 million and $1.8 million, respectively, which included $0.5 million and $1.7 million, respectively, related to the stated interest rate and $0.1 million and $0.1 million, respectively, related to the amortization of debt issuance costs. As of September 30, 2024, the carrying value of the Notes was $149.6 million, which is comprised of the $150.0 million principal amount of the Notes outstanding, less debt issuance costs of $0.4 million.

9. Stockholders’ Deficit

2023 Private Placement

On July 21, 2023, we entered into a Securities Purchase Agreement (the “July 2023 Private Placement”) with Rubric Capital Management L.P., Velan Capital, Clearline Capital and Hercules Capital, Inc. (collectively, the “Purchasers”) whereby we sold 20.7 million shares of our common stock in a private placement at a purchase price of $1.37 per share. In addition, as a component of the July 2023 Private Placement, we sold 1.2 million pre-funded warrants to purchase shares of our common stock at a purchase price of $1.3699 per share (the "July 2023 Pre-Funded Warrants"). The July 2023 Pre-Funded Warrants have an exercise price of $0.0001 per share. The total net proceeds from the sale of the common stock and the July 2023 Pre-Funded Warrants was $29.8 million (net of $0.2 million in issuance costs). The July 2023 Private Placement closed on July 25, 2023. In August 2023, we filed a registration statement with the SEC to register for resale 21.9 million shares of our common stock issued to the Purchasers. The registration statement was declared effective on August 31, 2023.

10. Equity Incentive Plan

Option Plan Activity

The following table summarizes the stock option activity for the nine months ended September 30, 2024:


	Shares (in thousands)			Weighted- Average Exercise Price		Weighted- Average Remaining Contractual Term (Years)
Outstanding at December 31, 2023		24,575		$	7.06		5.60
Granted		7,697		$	2.23
Exercised		(446	)	$	2.57
Expired and forfeited		(5,670	)	$	12.19
Outstanding at September 30, 2024		26,156		$	4.61		8.15

We estimated the fair value of each option grant on the grant date using the Black-Scholes option pricing model and for market-based stock option grants using the Monte Carlo simulation model. The following are the weighted-average assumptions:


	For the Nine Months Ended
	September 30,
	2024			2023
Risk-free interest rate		3.7	%		3.7	%
Dividend yield		0.0	%		0.0	%
Volatility		79.8	%		68.1	%
Expected life (years)	6 to 10			6 to 10

The following table summarizes the restricted stock unit (“RSU”) activity for the nine months ended September 30, 2024:


	Shares (in thousands)			Weighted-Average Grant Date Fair Value
Outstanding at December 31, 2023		1,405		$	4.43
Granted		1,533		$	2.29
Released		(928	)	$	2.66
Expired and forfeited		(463	)	$	3.69
Outstanding at September 30, 2024		1,547		$	2.74

The fair value of RSUs is estimated based on the closing market price of our common stock on the date of the grant. RSUs generally vest quarterly over a four-year period.

We estimate the fair value of each purchase right granted under our 1997 Employee Stock Purchase Plan, as amended, at the beginning of each new offering period using the Black-Scholes option pricing model. There were no new offering periods during the three months ended September 30, 2024.

Stock-Based Compensation

The following table summarizes stock-based compensation expense related to stock-based payment awards granted pursuant to all of our equity compensation arrangements (in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Research and development	$	361	$	1,193	$	1,615	$	5,624
General and administrative		1,671		3,989		5,609		14,445
Sales and marketing		690		1,501		3,443		8,461
Total stock-based compensation expense	$	2,722	$	6,683	$	10,667	$	28,530

As of September 30, 2024, there was $21.4 million of total unrecognized compensation cost related to non-vested, stock-based payment awards granted under all of our equity compensation plans and all non-plan option grants. Total unrecognized compensation cost will be adjusted for future changes in estimated forfeitures. We expect to recognize this compensation cost over a weighted-average period of three years.

11. Income Taxes

Deferred income tax assets and liabilities are recognized for temporary differences between financial statements and income tax carrying values using tax rates in effect for the years such differences are expected to reverse. Due to uncertainties surrounding our ability to generate future taxable income and consequently realize such deferred income tax assets, a full valuation allowance has been established. We continue to maintain a full valuation allowance against our deferred tax assets as of September 30, 2024.

The impact of an uncertain income tax position on the income tax return must be recognized at the largest amount that is more likely than not to be sustained upon audit by the relevant tax authority. An uncertain income tax position will be recognized when it is more likely than not of being sustained. The disclosures regarding uncertain tax positions included in our Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC on March 12, 2024, continue to be accurate for the three and nine months ended September 30, 2024.

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis of our financial condition and results of operations should be read together with our condensed consolidated financial statements and related notes included in this Quarterly Report on Form 10-Q and the audited financial statements and related notes included in our Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the U.S. Securities and Exchange Commission (“SEC”) on March 12, 2024 (the "2023 Annual Report").

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of the federal securities laws. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. In some cases, you can identify forward-looking statements by the use of the words “believe,” “expect,” “anticipate,” “intend,” “estimate,” “project,” “will,” “would,” “could,” “should,” “may,” “might,” “plan,” “assume” and other expressions that predict or indicate future events and trends and which do not relate to historical matters. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our future results of operations and financial position, business and commercialization strategy, products and product candidates, research pipeline, ongoing and planned preclinical studies and clinical trials, regulatory submissions and approvals, addressable patient population, research and development expenses, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. You should not rely on forward-looking statements because they involve known and unknown risks, uncertainties and other factors, some of which are beyond our control. These risks, uncertainties and other factors may cause our actual results, performance or achievements to be materially different from our anticipated future results, performance or achievements expressed or implied by the forward-looking statements.

Factors that might cause these differences include the following:

•

our ability to successfully commercialize, market and achieve market acceptance of ZYNRELEF® (bupivacaine and meloxicam) extended-release solution (“ZYNRELEF”), APONVIE® (aprepitant) injectable emulsion (“APONVIE”), CINVANTI® (aprepitant) injectable emulsion (“CINVANTI”), and SUSTOL® (granisetron) extended-release injection (“SUSTOL” and together with ZYNRELEF, APONVIE and CINVANTI, our "Products") in the United States (“U.S.”) , and our positioning relative to products that now or in the future compete with our Products or product candidates;

•

our estimates regarding the potential market opportunities for our Products and our product candidates, if approved, and our ability to capture the potential additional market opportunity from the expanded ZYNRELEF label recently approved in the U.S.;

•

our ability to establish and maintain successful commercial arrangements like our co-promotion agreement with CrossLink Life Sciences, LLC ("CrossLink");

•

the realization of anticipated benefits from our co-promotion agreement with CrossLink;

•

the outcome of our pending abbreviated new drug application litigation;

•

whether we are required to write-off any additional inventory in the future;

•

our ability to establish satisfactory pricing and obtain adequate reimbursement from government and third-party payors of our Products and product candidates that receive regulatory approvals;

•

whether study results of our Products and product candidates are indicative of the results in future studies;

•

the results of the commercial launch of APONVIE in the U.S.;

•

our ability to successfully launch VAN in the US;

•

the potential regulatory approval for, and commercial launch, of our product candidates, if approved;

•

our competitors’ activities, including decisions as to the timing of competing product launches, generic entrants, pricing and discounting;

•

whether safety and efficacy results of our clinical studies and other required tests for expansion of the indications for our Products and approval of our product candidates provide data to warrant progression of clinical trials, potential regulatory approval or further development of any of our Products or product candidates;

•

our ability to develop, acquire and advance product candidates into, and successfully complete, clinical studies, and our ability to submit for and obtain regulatory approval for product candidates in our anticipated timing, or at all;

•

our ability to meet the postmarketing study requirements within the mandated timelines of the U.S. Food and Drug Administration ("FDA")and to obtain favorable results and comply with standard postmarketing requirements, including U.S. federal advertising and promotion laws, federal and state anti-fraud and abuse laws, healthcare information privacy and security laws, safety information, safety surveillance and disclosure of payments or other transfers of value to healthcare professionals and entities for Products or any of our product candidates;

•

our ability to successfully develop and achieve regulatory approval for any product candidates utilizing our proprietary Biochronomer® drug delivery technology (“Biochronomer Technology”);

•

our ability to establish key collaborations and vendor relationships for our Products and our product candidates;

•

our ability to successfully develop and commercialize any technology that we may in-license or products we may acquire;

•

our reliance on third-party contract manufacturers to supply our Products and product candidates, if approved;

•

unanticipated delays due to manufacturing difficulties, supply constraints or changes in the regulatory environment, including as a result of geopolitical uncertainty;

•

our ability to successfully operate in non-U.S. jurisdictions in which we may choose to do business, including compliance with applicable regulatory requirements and laws;

•

uncertainties associated with obtaining and enforcing patents and trade secrets to protect our Products, our product candidates, our Biochronomer Technology and our other technology;

•

our ability to successfully defend ourselves against unforeseen third-party infringement claims and other litigation involving our Products and product candidates;

•

our estimates regarding our capital requirements;

•

the impact of our 2023 restructuring activities, including the reduced headcount and external spend;

•

our inability or delay in achieving profitability;

•

the impact of evolving legal and regulatory requirements and interpretations thereof, including emerging environmental, social and governance requirements and the recent U.S. Supreme Court decision regarding deference to federal administrative agencies' interpretations of federal statutes;

•

our ability to obtain additional financing and raise capital as necessary to fund operations or pursue business opportunities; and

•

those risks listed under the section entitled "Risk Factors" in Part I, Item 1A of the 2023 Annual Report.

Any forward-looking statements in this Quarterly Report on Form 10-Q reflect our current views with respect to future events or to our future financial performance. Given these uncertainties, you should not place undue reliance on these forward-looking statements. These forward-looking statements were based on information, plans and estimates as of the date of this Quarterly Report on Form 10-Q, and except as required by law, we assume no obligation to update any forward-looking statements to reflect changes in underlying assumptions or factors, new information, future events or other changes. These risk factors may be updated by our future filings under the Securities Exchange Act of 1934, as amended (“Exchange Act”). You should carefully review all information therein.

Overview

We are a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard of care for acute care and oncology patients.

Acute Care Product Portfolio

Our Acute Care Product Portfolio consists of ZYNRELEF, which is approved in the U.S. for the management of postoperative pain and APONVIE, which is approved in the U.S. for the prevention of postoperative nausea and vomiting.

ZYNRELEF

ZYNRELEF was initially approved by the FDA in May 2021, and we commenced commercial sales in the U.S. in July 2021. In each of December 2021 and January 2024, the FDA approved an expansion of ZYNRELEF's indication. ZYNRELEF is approved for small-to-medium open abdominal, lower extremity total joint arthroplasty, soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided.

ZYNRELEF is a dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of the nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first and only modified-release local anesthetic to be classified by the FDA as an extended-release product because ZYNRELEF demonstrated in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control.

In September 2024, the FDA approved the prior approval supplement (“PAS”) for the addition of a vial access needle (“VAN”) in the ZYNRELEF co-packaged combination product kit. The introduction of the VAN will replace the current vented vial spike and has the potential to simplify aseptic preparation, while also significantly reducing ZYNRELEF's withdrawal time down to between twenty and forty-five seconds. The user-friendly "container-like" design of the VAN may enhance the safe use of ZYNRELEF, increase adoption, and improve the preparation process. The VAN is expected to be available for use in the fourth quarter of 2024.

In January 2024, we entered into a five-year distributor partnership with CrossLink to expand the sales network supporting ZYNRELEF. CrossLink will be the lead partner in the U.S. to expand ZYNRELEF promotion for orthopedic indications. The partnership will launch in several phases, initially at a regional level, followed by an expanded national rollout. In total, we anticipate that approximately 650 representatives will be added to Heron’s sales network over 2024.

In March 2022, the Centers for Medicare and Medicaid Services (“CMS”) approved a 3-year transitional pass-through status of ZYNRELEF, which became effective on April 1, 2022, for separate reimbursement outside of the surgical bundle payment in the Hospital Outpatient Department setting of care. In addition, in December 2022, H.R. 2617, the omnibus spending bill was approved by Congress. The bill includes the Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act which directs CMS to provide separate Medicare reimbursement for non-opioid treatments that are used to manage pain during surgeries conducted in hospital outpatient departments or in ambulatory surgical centers. To qualify, the non-opioid treatment must demonstrate the ability to replace, reduce, or avoid intraoperative or postoperative opioid use or the quantity of opioids prescribed in a clinical trial or through data published in a peer-reviewed journal. The hospital outpatient prospective payment system and ambulatory surgical center proposed rule for calendar year 2025 includes ZYNRELEF as a qualifying non-opioid requiring CMS to provide separate Medicare reimbursement in both the hospital outpatient department and ambulatory surgical center settings from January 1, 2025, through December 31, 2027.

APONVIE

APONVIE was approved by the FDA in September 2022 and became commercially available in the U.S. in March 2023. APONVIE is indicated for the prevention of postoperative nausea and vomiting (“PONV”) in adults. CMS granted pass-through payment status for APONVIE, effective April 1, 2023.

APONVIE is the first and only intravenous formulation of a substance P/neurokinin-1 (“NK1”) receptor antagonist indicated for PONV. Delivered via a single 30-second intravenous (“IV”) injection, APONVIE has demonstrated rapid achievement of therapeutic drug levels ideally suited for the surgical setting.

Oncology Care Product Portfolio

Our Oncology Care Product portfolio consists of SUSTOL and CINVANTI, which are both approved in the U.S. for the prevention of chemotherapy-induced nausea and vomiting.

SUSTOL

SUSTOL was approved by the FDA in August 2016, and we commenced commercial sales in the U.S. in October 2016.

SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-hydroxytryptamine type 3 (“5-HT3”) receptor antagonist that utilizes our Biochronomer Technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL’s efficacy and safety in more than 2,000 patients with cancer. SUSTOL’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0–24 hours following chemotherapy) and the delayed phase (24–120 hours following chemotherapy).

SUSTOL is the first extended-release 5-HT3 receptor antagonist approved for the prevention of acute and delayed nausea and vomiting associated with both MEC and AC combination chemotherapy regimens. A standard of care in the treatment of breast cancer and other cancer types, AC regimens are among the most commonly prescribed HEC regimens, as defined by both the National Comprehensive Cancer Network (“NCCN”) and the American Society of Clinical Oncology (“ASCO”).

In February 2017, the NCCN included SUSTOL as a part of its NCCN Clinical Practice Guidelines in Oncology for Antiemesis Version 1.2017. The NCCN has given SUSTOL a Category 1 recommendation, the highest-level category of evidence and consensus, for use in the prevention of acute and delayed nausea and vomiting in patients receiving HEC or MEC regimens. The guidelines now identify SUSTOL as a “preferred” agent for preventing nausea and vomiting following MEC. Further, the guidelines highlight the unique, extended-release formulation of SUSTOL.

In January 2018, a product-specific billing code, or permanent J-code (“J-code”), for SUSTOL became available. The new J-code was assigned by CMS and has helped simplify the billing and reimbursement process for prescribers of SUSTOL.

CINVANTI

CINVANTI was approved by the FDA in November 2017, and we commenced commercial sales in the U.S. in January 2018. In each of February 2019 and October 2019, the FDA approved an expansion of CINVANTI of its administration and indication, respectively.

CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen, delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen, and nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen.

CINVANTI is an IV formulation of aprepitant, a substance NK1 receptor antagonist. CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND® capsules. Aprepitant (including its prodrug, fosaprepitant) is a single-agent NK1 receptor antagonist to significantly reduce nausea and vomiting in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy). CINVANTI is the first IV formulation of an NK1 receptor antagonist indicated for the prevention of acute and delayed nausea and vomiting associated with HEC and nausea and vomiting associated with MEC that is free of synthetic surfactants, including polysorbate 80.

NK1 receptor antagonists are typically used in combination with 5-HT3 receptor antagonists. Unlike CINVANTI many other injectable NK1 receptor antagonists currently approved in the U.S. for both acute and delayed chemotherapy induced nausea and vomiting (“CINV”), EMEND® IV (fosaprepitant), contains polysorbate 80, a synthetic surfactant, which has been linked to hypersensitivity reactions, including anaphylaxis, and infusion site reactions. The CINVANTI formulation does not contain polysorbate 80 or any other synthetic surfactant. Our CINVANTI data has demonstrated the bioequivalence of CINVANTI to EMEND IV, supporting its efficacy for the prevention of both acute and delayed nausea and vomiting associated with HEC and nausea and vomiting associated with MEC. Results also showed CINVANTI was better tolerated in healthy volunteers than EMEND IV, with significantly fewer adverse events reported with CINVANTI.

In January 2019, a J-code for CINVANTI became available. The new J-code was assigned by CMS and has helped simplify the billing and reimbursement process for prescribers of CINVANTI.

Biochronomer Technology

Our proprietary Biochronomer Technology is designed to deliver therapeutic levels of a wide range of otherwise short-acting pharmacological agents over a period from days to weeks with a single administration. Our Biochronomer Technology consists of polymers that have been the subject of comprehensive animal and human toxicology studies that have shown evidence of the safety of the polymer. When administered, the polymers undergo controlled hydrolysis, resulting in a controlled, sustained release of the pharmacological agent encapsulated within the Biochronomer-based composition. Furthermore, our Biochronomer Technology is designed to permit more than one pharmacological agent to be incorporated, such that multimodal therapy can be delivered with a single administration.

Critical Accounting Estimates

The discussion and analysis of our financial condition and results of operations are based on our condensed consolidated financial statements, which have been prepared in accordance with GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. We evaluate our estimates on an ongoing basis, including those related to revenue recognition, investments, inventory and the related reserves, accrued research and development expenses, income taxes and stock-based compensation. We base our estimates on historical experience and on assumptions that we believe to be reasonable under the circumstances, the results of which form the basis of making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ materially from these estimates under different assumptions or conditions.

Our critical accounting estimates include: revenue recognition, investments, inventory and the related reserves, accrued research and development expenses, income taxes, and stock-based compensation. There have been no material changes to our critical accounting estimates disclosures included in our 2023 Annual Report.

Recent Accounting Pronouncements

See Note 3 to the condensed consolidated financial statements included in Item 1 of this Quarterly Report on Form 10-Q.

Results of Operations for the Three and Nine Months Ended September 30, 2024 and 2023

Net Product Sales

For the three and nine months ended September 30, 2024, net product sales were $32.8 million and $103.5 million, respectively, compared to $31.4 million and $92.8 million, respectively, for the same periods in 2023.

Net Product Sales – Acute Care

For the three and nine months ended September 30, 2024, net product sales of ZYNRELEF were $6.3 million and $17.1 million, respectively, compared to $4.4 million and $12.0 million, respectively, for the same periods in 2023. For the three and nine months ended September 30, 2024, net product sales of APONVIE were $1.1 million and $2.6 million, respectively, compared to $0.3 million and $0.9 million, respectively, for the same periods in 2023. The increase in net product sales for both ZYNRELEF and APONVIE is attributed to an increase in the units sold in 2024 as compared to 2023.

Net Product Sales – Oncology Care

For the three and nine months ended September 30, 2024, net product sales of CINVANTI were $22.6 million and $73.2 million, respectively, compared to $23.3 million and $70.6 million, respectively, for the same periods in 2023. For the three and nine months ended September 30, 2024, net product sales of SUSTOL were $2.8 million and $10.6 million, respectively, compared to $3.4 million and $9.3 million, respectively, for the same periods in 2023. The decrease in net product sales for CINVANTI for the three months ended September 30, 2024, as compared to 2023 is attributed to an increase in units sold, offset by increased gross to net adjustments. The decrease in net product sales for SUSTOL for the three months ended September 30, 2024, as compared to 2023 is attributed to a decrease in units sold. The increase in net product sales for both CINVANTI and SUSTOL for the nine months ended September 30, 2024 as compared to 2023 is attributed to an increase in the units sold.

Cost of Product Sales

For the three and nine months ended September 30, 2024, cost of product sales was $9.5 million and $28.4 million, respectively, compared to $18.2 million and $55.2 million, respectively, for the same periods in 2023. Cost of product sales primarily included raw materials, labor and overhead related to the manufacturing of our Products, as well as shipping and distribution costs. For the three and nine months ended September 30, 2024, cost of product sales included charges of $0.8 million and $2.4 million, respectively relating to reserves and write-offs of inventory. For the three and nine months ended September 30, 2023, cost of product sales included charges of $7.5 million and $20.3 million, respectively, relating to the write-off of inventory. The remaining decrease in cost of product sales is attributed to a decrease in cost per units for CINVANTI and ZYNRELEF, as large-scale manufacturing was validated and approved in late 2022.

Research and Development Expense

Research and development expense consisted of the following (in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
SUSTOL-related costs	$	125	$	297	$	615	$	947
ZYNRELEF-related costs		1,831		2,185		3,549		7,812
CINVANTI-related costs		737		330		2,133		1,616
APONVIE-related costs		375		1,751		669		3,647
Personnel and related costs		1,036		3,529		4,924		11,685
Stock-based compensation expense		361		1,193		1,615		5,624
Total research and development expense	$	4,465	$	9,285	$	13,505	$	31,331

For the three and nine months ended September 30, 2024, research and development expense was $4.5 million and $13.5 million, respectively, compared to $9.3 million and $31.3 million, respectively, for the same periods in 2023. The decrease in research and development expense was primarily due to our decreased headcount and related costs as a result of the restructuring implemented in 2023, as well as a decrease in non-cash, stock-based compensation expense. The decrease is also due to decreases in costs related to ZYNRELEF, as large-scale manufacturing was approved in 2022, and APONVIE, as a result of the product becoming commercially available in March 2023.

General and Administrative Expense

For the three and nine months ended September 30, 2024, general and administrative expense was $12.4 million and $41.3 million, respectively, compared to $15.9 million and $51.3 million, respectively, for the same periods in 2023. The decrease was primarily due to our decreased headcount and related costs as a result of the restructuring implemented in 2023 and operational efficiencies.

Sales and Marketing Expense

For the three and nine months ended September 30, 2024, sales and marketing expense was $11.0 million and $36.0 million, respectively, compared to $13.0 million and $55.3 million, respectively, for the same period in 2023. The decrease was primarily due to our decreased headcount and related costs as a result of the restructuring implemented in 2023 and operational efficiencies.

Other (Expense) Income, Net

For the three and nine months ended September 30, 2024, other expense, net was $0.4 million and $1.5 million, respectively, compared to other (expense) income, net of ($0.1) million and $0.6 million, respectively, for the same period in 2023. The increase in other expense, net is attributed to increased interest expense as a result of the working capital facility agreement entered into in August 2023 (see Note 8 for further discussion of our working capital facility agreement) and the write-off of property and equipment during the three months ended June 30, 2024, which was associated with a project for which we had a one-time settlement related to a legal dispute.

Liquidity and Capital Resources

The Company's short-term and long-term liquidity requirements primarily arise from funding (i) sales and marketing expenses, (ii) general and administrative expenses including salaries, bonuses and commissions, (iii) working capital requirements, and (iv) research and development expenses, and (v) payments related to our outstanding convertible notes. As of September 30, 2024, we had cash, cash equivalents and short-term investments of $70.9 million. Based on our current operating plan and projections, management believes that the Company's cash, cash equivalents, short-term investments and working capital facility, will be sufficient to meet the Company's anticipated cash requirements for a period of at least the next twelve months from the date this Quarterly Report on Form 10-Q is filed with the SEC. Our future cash requirements and the adequacy of our available funds will depend on many factors, primarily including our ability to generate revenue and the scope and costs of our commercial and research and development activities.

Our net loss for the three and nine months ended September 30, 2024 was $4.8 million, or $0.03 per share, and $17.2 million, or $0.11 per share, respectively, compared to $25.0 million, or $0.17 per share, and $99.8 million, or $0.75 per share, respectively, for the same period in 2023.

Our net cash used in operating activities for the nine months ended September 30, 2024 and September 30, 2023 was $10.7 million and $61.2 million, respectively. The decrease in net cash used in operating activities was primarily due to a decrease in net loss as a result of decreases in operating spend and stock-based compensation expenses, primarily as a result of the restructuring implemented in 2023, the $4.3 million of write-offs of property and equipment during the nine months ended September 30, 2024, and changes in working capital, specifically accounts receivable due to timing of collections, inventory as a result of write-offs incurred, prepaid assets due to the timing of payments, and accounts payable and accrued expenses, including payroll and employee liabilities due to the timing of payments and reduced headcount.

Our net cash provided by investing activities for the nine months ended September 30, 2024, and September 30, 2023 was $7.3 million, and $26.8 million, respectively. The decrease in cash provided by investing activities was primarily due to net maturities of short-term investments of $8.4 million for the nine months ended September 30, 2024 compared to $28.1 million for the nine months ended September 30, 2023.

Our net cash provided by financing activities for the nine months ended September 30, 2024, and September 30, 2023 was $0.5 million, and $53.9 million, respectively. The decrease in cash provided by financing activities is a result of proceeds from the 2023 private placement and note financing, which did not recur in 2024.

Historically, we have financed our operations, including technology and product research and development, primarily through sales of our common stock, product sales and debt financings.

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Not required for smaller reporting companies.

ITEM 4. CONTROLS AND PROCEDURES

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports, filed or submitted under the Exchange Act, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, including, without limitation, controls and procedures designed to ensure that information required to be disclosed in such reports is accumulated and communicated to our management, including our principal executive officer, principal financial officer, and principal accounting officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable and not absolute assurance of achieving the desired control objectives. In reaching a reasonable level of assurance, management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. In addition, the design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, a control may become inadequate because of changes in conditions or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

Our management, with the participation of our principal executive officer, principal financial officer and principal accounting officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act), as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on the foregoing, our principal executive officer, principal financial officer, and principal accounting officer concluded that our disclosure controls and procedures were effective as of such time.

There were no changes in our internal control over financial reporting that occurred during the quarter covered by this Quarterly Report on Form 10-Q that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II. OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS

Except as discussed below, there are no material changes from the legal proceedings previously disclosed in our most recently filed Annual Report on Form 10-K for the year ended December 31, 2023.

On June 14, 2022, the Company received a Notice Letter (the “Fresenius Kabi Notice”) from Fresenius Kabi advising that Fresenius Kabi had submitted an ANDA to the FDA seeking approval to manufacture, use or sell a generic version of CINVANTI in the U.S. prior to the expiration of U.S. Patent Nos.: 9,561,229; 9,808,465; 9,974,742; 9,974,793; 9,974,794; 10,500,208; 10,624,850; 10,953,018; and 11,173,118 (the “CINVANTI Patents”), which are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”). The Fresenius Kabi Notice alleges that the CINVANTI Patents are invalid, unenforceable and/or will not be infringed by the commercial manufacture, use or sale of the generic product described in Fresenius Kabi’s ANDA. On July 27, 2022, the Company filed a complaint for patent infringement of the CINVANTI Patents against Fresenius Kabi and a related entity in the U.S. District Court for the District of Delaware in response to Fresenius Kabi’s ANDA filing. The complaint seeks, among other relief, equitable relief enjoining Fresenius Kabi from infringing the CINVANTI Patents. On May 15, 2024, the Court granted partial summary judgment of infringement for the Company and found no indefiniteness of U.S. Patent Nos. 9,561,229 and 9,974,794. On June 24, 2024, the parties completed a four-day bench trial centered on Fresenius’s defense of obviousness of claims from U.S. Patent Nos. 9,561,229 and 9,974,794 that cover CINVANTI. Oral argument was held on August 29, 2024. The parties are currently awaiting the Court’s decision. The Company intends to vigorously enforce its intellectual property rights relating to CINVANTI. As a result of filing our complaint for patent infringement, the FDA may not approve Fresenius’s ANDA until the earlier of December 14, 2024 or resolution of the litigation.

On August 4, 2023, the Company received a Notice Letter (the “Mylan August Notice”) from Mylan Pharmaceuticals Inc. (“Mylan”) advising that Mylan had submitted an ANDA to the FDA seeking approval to manufacture, use or sell a generic version of CINVANTI (“Mylan’s ANDA for a generic version of CINVANTI”) in the U.S. prior to the expiration of the CINVANTI Patents, which are listed in the Orange Book. The Mylan August Notice alleges that the CINVANTI Patents are invalid, unenforceable and/or will not be infringed by the commercial manufacture, use or sale of the generic product described in Mylan’s ANDA for a generic version of CINVANTI. On September 15, 2023, the Company filed a complaint for patent infringement of the CINVANTI Patents against Mylan in the U.S. District Court for the District of Delaware in response to the filing of Mylan’s ANDA for a generic version of CINVANTI. The complaint seeks, among other relief, equitable relief enjoining Mylan from infringing the CINVANTI Patents. On November 9, 2023, the Company received an updated Notice Letter from Mylan advising that it had submitted an amendment to Mylan’s ANDA to include a paragraph IV certification to Heron’s recently listed U.S. Patent No. 11,744,800. The parties completed fact discovery and are progressing into expert discovery. A five-day bench trial is scheduled for May 19, 2025. The Company intends to vigorously enforce its intellectual property rights relating to CINVANTI. As a result of filing our complaint for patent infringement, the FDA may not approve Mylan’s ANDA for a generic version of CINVANTI until the earlier of February 4, 2026 or resolution of the litigation.

On December 16, 2023, the Company received a Notice Letter (the “Mylan December Notice”) from Mylan advising that Mylan had submitted an ANDA to the FDA seeking approval to manufacture, use or sell a generic version of APONVIE in the U.S. (“Mylan’s ANDA for a generic version of APONVIE”) prior to the expiration of U.S. Patent Nos.: 9,561,229; 9,808,465; 9,974,742; 9,974,793; 9,974,794; 10,500,208; 10,624,850; 10,953,018; 11,173,118; and 11,744,800 (the “APONVIE Patents”), which are listed in the Orange Book. The Mylan December Notice Letter alleges that the APONVIE Patents are invalid, unenforceable and/or will not be infringed by the commercial manufacture, use or sale of the generic product described in Mylan’s ANDA for a generic version of APONVIE. On January 11, 2024, the Company filed a complaint for patent infringement of the APONVIE Patents against Mylan in the U.S. District Court for the District of Delaware in response to Mylan filing an ANDA for a generic version of APONVIE. The complaint seeks, among other relief, equitable relief enjoining Mylan from infringing the APONVIE Patents. On January 26, 2024, the Court consolidated this litigation concerning Mylan’s ANDA for a generic version of APONVIE with the previously-filed litigation concerning Mylan’s ANDA for a generic version of CINVANTI. Accordingly, a five-day bench trial is scheduled for May 19, 2025. The Company intends to vigorously enforce its intellectual property rights relating to APONVIE. As a result of filing our complaint for patent infringement, the FDA may not approve Mylan’s ANDA for a generic version of APONVIE until the earlier of June 16, 2026 or resolution of the litigation.

On December 12, 2023, the Company received a Notice Letter (the “Slayback Notice”) from Slayback Pharma LLC (“Slayback”) advising that Slayback had submitted an NDA under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act to the FDA seeking approval to manufacture, use or sell a generic version of CINVANTI in the U.S. (“Slayback’s NDA”) prior to the

expiration of the patents, listed in the Orange Book. The Slayback Notice alleges that the CINVANTI Patents are invalid, unenforceable and/or will not be infringed by the commercial manufacture, use or sale of the generic product described in Slayback’s NDA. On January 24, 2024, the Company filed a complaint for patent infringement of the CINVANTI Patents against Slayback and a related entity in the U.S. District Court for the District of New Jersey in response to Slayback’s NDA filing. The complaint seeks, among other relief, equitable relief enjoining Slayback from infringing those patents. On July 2, 2024, the U.S. District Court for the District of New Jersey granted Slayback’s motion to transfer this matter to the U.S. District Court for the District of Delaware. A four-day bench trial is scheduled for January 20, 2026. The Company intends to vigorously enforce its intellectual property rights relating to CINVANTI. As a result of filing our complaint for patent infringement, the FDA may not approve Slayback's NDA until the earlier of June 12, 2026, or resolution of the litigation.

ITEM 1A. RISK FACTORS

We operate in a rapidly changing environment that involves a number of risks that could materially affect our business, financial condition or future results, some of which are beyond our control. In addition to the other information set forth in this report, the risks and uncertainties that we believe are most important for you to consider are discussed in Part I, “Item 1A. Risk Factors” in the 2023 Form 10-K and in Part II, “Item 1A. Risk Factors” in our subsequently filed Quarterly Reports on Form 10-Q. Other than the factors set forth below, there have been no material changes to the risk factors described in the 2023 Form 10-K.

We face intense competition from other companies developing products for the management of postoperative pain or the prevention of CINV and PONV.

ZYNRELEF competes in the postoperative pain management market with MARCAINETM (bupivacaine hydrochloride injection, solution, marketed by Pfizer Inc.) and generic forms of bupivacaine; NAROPIN® (ropivacaine, marketed by Fresenius Kabi USA, LLC) and generic forms of ropivacaine; EXPAREL® (bupivacaine liposome injectable suspension, marketed by Pacira BioSciences, Inc.); XARACOLL®(bupivacaine HCl implant, marketed by Innocoll Pharmaceuticals Limited); POSIMIR® (owned by Durect Corporation and to be marketed in the U.S. by Innocoll Pharmaceuticals Limited); ANJESO® (meloxicam injection, marketed by Baudax Bio, Inc.); OFIRMEV® (acetaminophen injection, marketed by Mallinckrodt Pharmaceuticals); SEGLENTIS® (celecoxib and tramadol hydrochloride, marketed by Kowa Pharmaceuticals America, Inc. in the U.S.); generic forms of IV acetaminophen; and potentially other products in development for postoperative pain management that reach the U.S. market.

APONVIE competes in the PONV prevention market with generic ondansetron, the current standard of care, generic aprepitant, and BARHEMSYS® (amisulpride, marketed by Eagle Pharmaceuticals, Inc.); TAK-951 (a peptide agonist under development (PH2) by Takeda Pharmaceutical Company Limited for PONV and not approved anywhere globally for any use); and potentially other products in development for PONV prevention that reach the market.

CINVANTI faces significant competition. NK1 receptor antagonists are administered for the prevention of CINV, in combination with 5-HT3 receptor antagonists, to augment the therapeutic effect of the 5-HT3 receptor antagonist. Currently available NK1receptor antagonists include: generic versions of EMEND® IV (fosaprepitant); EMEND® IV (fosaprepitant, marketed by Merck & Co., Inc.); EMEND® (aprepitant, marketed by Merck & Co., Inc.); AKYNZEO®(palonosetron, a 5-HT3 receptor antagonist, combined with netupitant, an NK1 receptor antagonist, marketed by Helsinn Therapeutics (U.S.), Inc.); VARUBI® (rolapitant, marketed by TerSera Therapeutics LLC), FOCINVEZTM (fosaprepitant injection, marketed by Amneal Pharmaceuticals, LLC) and other products that include an NK1 receptor antagonist that reach the market for the prevention of CINV.

SUSTOL faces significant competition. Currently available 5-HT3 receptor antagonists include: AKYNZEO® (palonosetron, a 5-HT3 receptor antagonist, combined with netupitant, an NK1 receptor antagonist, marketed by Helsinn Therapeutics (U.S.), Inc.); SANCUSO® (granisetron transdermal patch, marketed by Cumberland Pharmaceuticals Inc.); and generic products including ondansetron (formerly marketed by GlaxoSmithKline plc as ZOFRAN), granisetron (formerly marketed by Hoffman-La Roche, Inc. as KYTRIL), palonosetron (formerly marketed by Eisai in conjunction with Helsinn Healthcare S.A. as ALOXI) and Posfrea (Palonosetron Injection, marketed by AVYXA). Currently, palonosetron is the only 5-HT3receptor antagonist other than SUSTOL that is approved for the prevention of delayed CINV associated with MEC regimens. SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens, which is considered to be a HEC regimen by the NCCN and ASCO. No other 5-HT3 receptor antagonist is specifically approved for the prevention of delayed CINV associated with a HEC regimen.

Small or early-stage companies and research institutions may also prove to be significant competitors, particularly through collaborative arrangements with large and established pharmaceutical companies. We will also face competition from these parties in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and patient registration for clinical trials, and acquiring and in-licensing technologies and products complementary to our programs or potentially advantageous to our business. If any of our competitors succeed in obtaining approval from the FDA or other regulatory authorities for their product candidates sooner than we do for our product candidates that are more effective or less costly than ours, our commercial opportunity could be significantly reduced. Major technological changes can happen quickly in the biotechnology and pharmaceutical industries, and the development of technologically improved or different products or drug delivery technologies may make our product candidates or platform technologies obsolete or noncompetitive.

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

None.

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

None.

ITEM 4. MINE SAFETY DISCLOSURES

Not applicable.

ITEM 5. OTHER INFORMATION

None.

ITEM 6. EXHIBITS


Exhibit Number		Description

3.1		Certificate of Incorporation, as amended through July 29, 2009 (incorporated by reference to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, as Exhibit 3.1, filed on August 9, 2009)

3.2		Certificate of Amendment of Certificate of Incorporation (incorporated by reference to our Current Report on Form 8-K, as Exhibit 3.1, filed on June 30, 2011)

3.3		Certificate of Amendment to the Certificate of Incorporation (incorporated by reference to our Current Report on Form 8-K, as Exhibit 3.1, filed on January 13, 2014

3.4		Certificate of Amendment to the Certificate of Incorporation (incorporated by reference to our Company's Post-Effective Amendment to its Registration Statement on Form 8-A/A, filed on July 6, 2017)

3.5		Certificate of Amendment of Certificate of Incorporation (incorporated by reference to our Annual Report on Form 10-K for the year ended December 31, 2018, as exhibit 3.6, filed on February 22, 2019)

3.6		Certificate of Amendment to the Certificate of Incorporation (incorporated by reference to our Current Report on Form 8-K, as exhibit 3.1, filed on June 12, 2023)

3.7		Certificate of Amendment to the Certificate of Incorporation (incorporated by reference to our Current Report on Form 8-K, as exhibit 3.1, filed on June 18, 2024)

3.8		Amended and Restated Bylaws (incorporated by reference to our Current Report on Form 8-K, as Exhibit 3.1, filed on February 8, 2019)

10.1+*		Amendment No. 1 to Co-Promotion Agreement, dated as of January 5, 2024, by and between the Company and Crosslink Network, LLC

10.2+*		Amendment No. 2 to Co-Promotion Agreement, dated as of January 5, 2024, by and between the Company and Crosslink Network, LLC

31.1+		Certification of Principal Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

31.2+		Certification of Principal Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

32.1++		Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

101.INS		XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.

101.SCH		Inline XBRL Taxonomy Extension Schema Document

101.CAL		Inline XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF		Inline XBRL Extension Definition

101.LAB		Inline XBRL Taxonomy Extension Label Linkbase Document

101.PRE		Inline XBRL Taxonomy Extension Presentation Linkbase Document

104		Cover Page Interactive Data File (embedded within the Inline XBRL document included as Exhibit 101)

+ Filed herewith

++ Furnished herewith

* Certain information has been omitted from the exhibit pursuant to Item 601 of Regulation S-K

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.


		Heron Therapeutics, Inc.

Date: November 12, 2024		/s/ Craig Collard
		Craig Collard
		Chief Executive Officer
		(As Principal Executive Officer)

		/s/ Ira Duarte
		Ira Duarte
		Executive Vice President, Chief Financial Officer
		(As Principal Financial Officer and Principal Accounting Officer)