Sufentanil

Zevra’s MIPLYFFA™ (arimoclomol) received FDA approval and became the sixth commercial asset in XOMA Royalty’s portfolio XOMA Royalty acquired a 50 percent economic interest in TWIST Bioscience’s portfolio of 60-plus licensed early-stage assets across approximately 30 partners Cash receipts totaled $9.9 million in the third quarter, and $42.3 million for the first nine months of 2024 EMERYVILLE, Calif., Nov. 07, 2024 (GLOBE NEWSWIRE) -- XOMA Royalty Corporation (NASDAQ: XOMA), the biotech royalty aggregator, reported its third quarter 2024 financial results and highlighted recent activities. “We continue to take a balanced approach to building a portfolio of sustainable cashflow streams by selectively acquiring royalty economics across the lifecycle of drug development,” stated Owen Hughes, Chief Executive Officer of XOMA Royalty. “The September approval of MIPLYFFA™, the first therapy approved for patients living with Niemann-Pick disease Type C, adds to our growing commercial royalty portfolio, while the recent transaction with Twist Bioscience further expands our early-stage portfolio, a key focus for us as we look to distribute risk across a diversified portfolio.” Key Third Quarter Events PartnerEventZevra TherapeuticsThe U.S. Food and Drug Administration (FDA) approved Zevra’s MIPLYFFA™ (arimoclomol) capsules as an orally delivered treatment for Niemann-Pick disease type C (NPC). MIPLYFFA™ is indicated for use in combination with miglustat for the treatment of neurological manifestations of NPC in adult and pediatric patients 2 years of age and older.RezoluteAnnounced the sunRIZE Phase 3 clinical trial investigating ersodetug (RZ358) in patients with congenital hyperinsulinism (CHI) will begin enrolling patients in the U.S. in early 2025¹.Received FDA clearance to initiate Phase 3 registrational study for ersodetug for the treatment of hypoglycemia due to tumor hyperinsulinism².Johnson & JohnsonPresented neoadjuvant TAR-200 plus cetrelimab Phase 2 data in patients with muscle-invasive bladder cancer (MIBC) who are ineligible or refuse neoadjuvant platinum-based chemotherapy and are scheduled for radical cystectomy at the European Society of Medical Oncology 2024 Congress³. Subsequent Events PartnerEventTwist BioscienceXOMA Royalty completed a $15 million royalty monetization agreement with Twist, acquiring 50% of the future milestones and royalties and adding 60-plus partnered early-stage programs across 30 companies enabled by Twist Bioscience’s Biopharma Solutions business unit to the XOMA Royalty portfolio.Johnson & JohnsonAnnounced one of two Phase 3 clinical trials in difficult to treat muscle-invasive bladder cancer (MIBC) that included treatment with cetrelimab was being discontinued for not showing superiority to chemoradiation during a scheduled interim analysis⁴. Cetrelimab continues to be investigated in multiple other clinical trials. Anticipated 2024 Events of Note PartnerEventTakedaOn December 12, 2024, Takeda will be hosting an R&D Day: Focus on Late-State Pipeline and Market Opportunity and has commented publicly mezagitamab will be discussed during this investor event. Third Quarter 2024 Financial Results XOMA Royalty recorded total income and revenues of $7.2 million for the third quarter of 2024, which included $6.5 million in estimated income associated with two commercial products in our portfolio. In the third quarter of 2023, XOMA Royalty reported total income and revenue of $0.8 million. Research and development (R&D) expenses were $0.8 million in the third quarter of 2024, reflecting transitory clinical trial costs related to KIN-3248, an asset acquired in the Kinnate acquisition, which the Company currently is winding down. R&D expenses in the third quarter of 2023 were $25,000. General and administrative (“G&A”) expenses were $8.0 million for the third quarter of 2024 compared with $6.4 million in the third quarter of 2023. The increase of $1.6 million was primarily comprised of $1.4 million in total costs incurred after our acquisition of Kinnate, which included $1.1 million in legal and consulting costs, $0.1 million in information technology costs, and $0.1 million in insurance costs. The remainder of the increased G&A expense reflects an increase of $0.2 million for salaries and related costs. In the third quarter of 2024, as a result of communications with Agenus, XOMA Royalty evaluated the status of the partnered programs underlying the Agenus Royalty Purchase Agreement for potential impairment and recorded a one-time, non-cash impairment charge of $14.0 million and a reduction of royalty receivables of $14.0 million associated with Agenus. In the third quarters of 2024 and 2023, G&A expenses included $2.6 million and $2.7 million, respectively, in non-cash stock-based compensation expenses. Total interest expense in the third quarter of 2024 was $3.5 million, representing interest and costs related to the Blue Owl Loan established in December 2023. The Company reported total other income, net, of $1.9 million in the third quarter of 2024, as compared to total other income, net, of $0.3 million in the corresponding period of 2023. The $1.6 million increase reflects a $1.3 million increase in investment income due to higher balances on our investments and the change in the market price for XOMA Royalty’s shares of Rezolute common stock. Net loss for the third quarter of 2024 was $17.2 million, compared to a net loss of $5.5 million for the third quarter of 2023, primarily resulting from the $14.0 million non-cash impairment related to the Agenus Royalty Purchase Agreement. On September 30, 2024, XOMA Royalty had cash and cash equivalents of $146.8 million (including $4.8 million in restricted cash). On December 31, 2023, XOMA Royalty had cash and cash equivalents of $159.6 million (including $6.3 million in restricted cash). During the third quarter of 2024, XOMA Royalty received $9.9 million in cash from royalty and commercial payments. Net cash used in operating activities during the quarter was $8.6 million. On October 15, 2024, the Company paid a total of $1.4 million in cash dividends on the 8.625% Series A Cumulative Perpetual Preferred Stock (Nasdaq: XOMAP) and the 8.375% Series B Cumulative Perpetual Preferred Stock (Nasdaq: XOMAO). About XOMA Royalty Corporation XOMA Royalty is a biotechnology royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of improving human health. XOMA Royalty acquires the potential future economics associated with pre-commercial and commercial therapeutic candidates that have been licensed to pharmaceutical or biotechnology companies. When XOMA Royalty acquires the future economics, the seller receives non-dilutive, non-recourse funding they can use to advance their internal drug candidate(s) or for general corporate purposes. The Company has an extensive and growing portfolio of assets (asset defined as the right to receive potential future economics associated with the advancement of an underlying therapeutic candidate). For more information about the Company and its portfolio, please visit www.xoma.com or follow XOMA Royalty Corporation on LinkedIn. Forward-Looking Statements/Explanatory Notes Certain statements contained in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements regarding the timing and amount of potential commercial payments to XOMA Royalty and other developments related to VABYSMO® (faricimab-svoa), OJEMDA™ (tovorafenib), MIPLYFFA™ (arimoclomol), XACIATO™ (clindamycin phosphate) vaginal gel 2%, IXINITY® [coagulation factor IX (recombinant)], and DSUVIA® (sufentanil sublingual tablet); the potential occurrences of the events listed under “Anticipated 2024 Events of Note”; the anticipated timings of regulatory filings and approvals related to assets in XOMA Royalty’s portfolio; and the potential of XOMA Royalty’s portfolio of partnered programs and licensed technologies generating substantial milestone and royalty proceeds over time. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” “expect,” “may,” “will”, “would,” “could” or “should,” the negative of these terms or similar expressions. These forward-looking statements are not a guarantee of XOMA Royalty’s performance, and you should not place undue reliance on such statements. These statements are based on assumptions that may not prove accurate, and actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry, including those related to the fact that our product candidates subject to out-license agreements are still being developed, and our licensees may require substantial funds to continue development which may not be available; we do not know whether there will be, or will continue to be, a viable market for the products in which we have an ownership or royalty interest; and if the therapeutic product candidates to which we have a royalty interest do not receive regulatory approval, our third-party licensees will not be able to market them. Other potential risks to XOMA Royalty meeting these expectations are described in more detail in XOMA Royalty's most recent filing on Form 10-Q and in other filings with the Securities and Exchange Commission. Consider such risks carefully when considering XOMA Royalty's prospects. Any forward-looking statement in this press release represents XOMA Royalty's beliefs and assumptions only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. XOMA Royalty disclaims any obligation to update any forward-looking statement, except as required by applicable law. EXPLANATORY NOTE: Any references to “portfolio” in this press release refer strictly to milestone and/or royalty rights associated with a basket of drug products in development. Any references to “assets” in this press release refer strictly to milestone and/or royalty rights associated with individual drug products in development. As of the date of this press release, the commercial assets in XOMA Royalty’s milestone and royalty portfolio are VABYSMO® (faricimab-svoa), OJEMDA™ (tovorafenib), MIPLYFFA™ (arimoclomol), XACIATO™ (clindamycin phosphate) vaginal gel 2%, IXINITY® [coagulation factor IX (recombinant)], and DSUVIA® (sufentanil sublingual tablet). All other assets in the milestone and royalty portfolio are investigational compounds. Efficacy and safety have not been established. There is no guarantee that any of the investigational compounds will become commercially available. XOMA ROYALTY CORPORATIONCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(unaudited)(in thousands, except per share amounts) Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2024 2023 2024 2023 Income and revenues: Income from purchased receivables $6,463 $— $11,895 $— Revenue from contracts with customers 25 225 6,050 1,350 Revenue recognized under units-of-revenue method 709 605 1,828 1,575 Total income and revenues 7,197 830 19,773 2,925 Operating expenses: Research and development 817 25 2,011 118 General and administrative 8,020 6,368 27,485 18,341 Royalty purchase agreement asset impairment 14,000 — 23,000 1,575 Arbitration settlement costs — — — 4,132 Amortization of intangible assets — 224 — 673 Total operating expenses 22,837 6,617 52,496 24,839 Loss from operations (15,640) (5,787) (32,723) (21,914) Other income (expense): Gain on the acquisition of Kinnate — — 19,316 — Change in fair value of embedded derivative related to RPA — — 8,100 — Interest expense (3,493) — (10,446) — Other income (expense), net 1,890 278 5,900 1,192 Net loss $(17,243) $(5,509) $(9,853) $(20,722) Net loss attributable to common stockholders, basic $(18,611) $(6,877) $(13,957) $(24,826)Basic net loss per share attributable to common stockholders $(1.59) $(0.60) $(1.20) $(2.17)Weighted average shares used in computing basic net loss per share attributable to common stockholders 11,712 11,473 11,645 11,466 Net loss attributable to common stockholders, diluted $(18,611) $(6,877) $(13,957) $(24,826)Diluted net loss per share attributable to common stockholders $(1.59) $(0.60) $(1.20) $(2.17)Weighted average shares used in computing diluted net loss per share attributable to common stockholders 11,712 11,473 11,645 11,466 XOMA ROYALTY CORPORATIONCONDENSED CONSOLIDATED BALANCE SHEETS(in thousands, except share and per share amounts) September 30, December 31, 2024 2023 ASSETS (unaudited) Current assets: Cash and cash equivalents $142,050 $153,290 Short-term restricted cash 80 160 Short-term equity securities 785 161 Trade and other receivables, net 1,045 1,004 Short-term royalty and commercial payment receivables 12,682 14,215 Prepaid expenses and other current assets 2,379 483 Total current assets 159,021 169,313 Long-term restricted cash 4,686 6,100 Property and equipment, net 34 25 Operating lease right-of-use assets 335 378 Long-term royalty and commercial payment receivables 54,207 57,952 Exarafenib milestone asset 3,125 — Other assets - long term 1,932 533 Total assets $223,340 $234,301 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $1,131 $653 Accrued and other liabilities 2,451 2,768 Contingent consideration under RPAs, AAAs, and CPPAs 4,000 7,000 Operating lease liabilities 434 54 Unearned revenue recognized under units-of-revenue method 1,924 2,113 Preferred stock dividend accrual 1,368 1,368 Current portion of long-term debt 9,826 5,543 Total current liabilities 21,134 19,499 Unearned revenue recognized under units-of-revenue method – long-term 5,589 7,228 Exarafenib milestone contingent consideration 3,125 — Long-term operating lease liabilities 594 335 Long-term debt 108,089 118,518 Total liabilities 138,531 145,580 Stockholders’ equity: Preferred Stock, $0.05 par value, 1,000,000 shares authorized: 8.625% Series A cumulative, perpetual preferred stock, 984,000 shares issued and outstanding at September 30, 2024 and December 31, 2023 49 49 8.375% Series B cumulative, perpetual preferred stock, 1,600 shares issued and outstanding at September 30, 2024 and December 31, 2023 — — Convertible preferred stock, 5,003 issued and outstanding at September 30, 2024 and December 31, 2023 — — Common stock, $0.0075 par value, 277,333,332 shares authorized, 11,755,223 and 11,495,492 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively 88 86 Additional paid-in capital 1,317,657 1,311,809 Accumulated other comprehensive income 104 — Accumulated deficit (1,233,089) (1,223,223)Total stockholders’ equity 84,809 88,721 Total liabilities and stockholders’ equity $223,340 $234,301 XOMA ROYALTY CORPORATIONCONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS(unaudited)(in thousands) Nine Months EndedSeptember 30, 2024 2023 Cash flows from operating activities: Net loss $(9,853) $(20,722)Adjustments to reconcile net loss to net cash used in operating activities: Income from purchased receivables under effective interest rate method (9,985) — Stock-based compensation expense 8,136 6,450 Royalty purchase agreement asset impairment 23,000 1,575 Gain on the acquisition of Kinnate (19,316) — Change in fair value of contingent consideration under RPAs, AAAs, and CPPAs — (75)Common stock contribution to 401(k) 118 123 Amortization of intangible assets — 673 Depreciation 8 2 Accretion of long-term debt discount and debt issuance costs 996 — Non-cash lease expense 45 115 Change in fair value of equity securities (624) 121 Change in fair value of available-for-sale debt securities classified as cash equivalents 104 — Changes in assets and liabilities: Trade and other receivables, net (41) (42)Prepaid expenses and other assets (72) (202)Accounts payable and accrued liabilities (1,348) (554)Operating lease liabilities (185) (120)Unearned revenue recognized under units-of-revenue method (1,828) (1,575) Net cash used in operating activities (10,845) (14,231) Cash flows from investing activities: Net cash acquired in Kinnate acquisition 18,926 — Payments of consideration under RPAs, AAAs, and CPPAs (37,000) (14,650)Receipts under RPAs, AAAs, and CPPAs 26,263 8,428 Purchase of property and equipment (17) — Net cash provided by (used in) investing activities 8,172 (6,222) Cash flows from financing activities: Principal payments — debt (6,902) — Debt issuance costs and loan fees paid in connection with long-term debt (740) — Payment of preferred stock dividends (4,104) (4,104)Repurchases of common stock (13) — Proceeds from exercise of options and other share-based compensation 4,127 208 Taxes paid related to net share settlement of equity awards (2,429) (5) Net cash used in financing activities (10,061) (3,901) Net decrease in cash, cash equivalents, and restricted cash (12,734) (24,354)Cash, cash equivalents, and restricted cash as of the beginning of the period 159,550 57,826 Cash, cash equivalents, and restricted cash as of the end of the period $146,816 $33,472 Supplemental Cash Flow Information: Cash paid for interest $9,985 $— Right-of-use assets obtained in exchange for operating lease liabilities $— $85 Non-cash investing and financing activities: Estimated initial fair value of the Exarafenib milestone asset in Kinnate acquisition $2,922 $— Estimated initial fair value of the Exarafenib milestone contingent consideration in Kinnate acquisition $2,922 $— Right-of-use assets obtained in exchange for operating lease liabilities in Kinnate acquisition $824 $— Relative fair value basis reduction of right-of-use assets in Kinnate acquisition $(824) $— Accrual of contingent consideration under the Affitech CPPA $3,000 $3,000 Accrual of contingent consideration under the LadRx AAA $1,000 — Estimated fair value of contingent consideration under the LadRx Agreements $— $1,000 Preferred stock dividend accrual $1,368 $1,368 Investor contact:Media contact:Juliane SnowdenKathy VincentXOMA Royalty CorporationKV Consulting & Management+1-646-438-9754+1-310-403-8951juliane.snowden@xoma.comkathy@kathyvincent.com _____________________________________¹ https://ir.rezolutebio.com/news/detail/339/fda-lifts-partial-clinical-holds-on-rz358-for-the-treatment-of-congenital-hyperinsulinism-and-authorizes-u-s-inclusion-in-ongoing-phase-3-study² https://ir.rezolutebio.com/news/detail/337/rezolute-announces-fda-clearance-of-ind-application-for-phase-3-registrational-study-of-rz358-for-treatment-of-hypoglycemia-due-to-tumor-hyperinsulinism³ https://www.jnj.com/media-center/press-releases/neoadjuvant-tar-200-plus-cetrelimab-nearly-doubles-the-pathological-complete-response-rate-compared-to-cetrelimab-alone-in-patients-with-muscle-invasive-bladder-cancer⁴ https://www.jnj.com/media-center/press-releases/johnson-johnson-statement-on-the-sunrise-2-study

迎战“一哥”，抢夺麻醉用药市场最大的“蛋糕”，对于身处第二梯队的恩华药业来说，是压力，也是动力。 撰文| 润屿 当下，能给予医药资本市场“安全感”的领域，最好有稳定的预期及较强的增长确定性。但在周期下行、存量竞争激烈的背景下，这样的领域并不多。感冒用药是一个，代表企业如济川药业、华润三九；肠胃用药是一个，代表企业如康恩贝、江中药业；“狗皮膏药”是一个，代表企业有中药贴膏标的羚锐制药，化药贴膏龙头九典制药。还有一个，其确定性相对还要更高——专注于麻醉类药物的企业。 麻醉类药物的生产和销售受到严格管制，背后的生产销售企业，具有极强的专业性，较高技术、市场准入及资金规模壁垒，以及较高的生产集中度。国内整个麻醉药物市场，还算不太“内卷”，竞争格局较为稳定。 A股麻醉用药相关业务占比超50%的企业主要有两家：人福医药和恩华药业。论业务，前者优势在于镇痛，后者优势在于镇静。论体量和渠道沉淀，人福医药是当之无愧的“一哥”，恩华药业处在第二梯队。但在近几年，两者业务愈发交叉，人福医药从镇痛进入镇静领域，恩华药业则从镇静“入侵”镇痛领域，后者带着“羟瑞舒阿”产品，进攻态势尤其猛烈。受此影响，人福医药在资本市场的表现不敌后者，过去3年，人福医药股价涨近9%，恩华药业涨逾100%。 不过，3年前，恩华药业给自己树立了一个目标：“一、二、九、二十、百。”其中，“百”指在”十四五”末实现百亿元销售规模。但2023年，恩华药业营收为50.42亿元，2024年上半年为27.63亿元，看似离目标达成还有较大距离。 再者，麻醉药物原本迭代慢、生命周期颇长，但在近两年迎来了技术迭代的关键转折期，恩华药业给人福医药等企业带来威胁的同时，也受到了来自人福医药、恒瑞医药、苑东生物、海思科等迭代药物的竞争压力。 在突围与反突围进程中，留给恩华药业“赶KPI”的时间不多了。 机构扎堆的稳健型“选手” 周期震荡下，投资者的偏好发生了变化。其一，尤其看重企业自身的经营能力和盈利能力。其二，更看好稳健资产。 2019-2023年，恩华药业持股机构数增长约5倍，再结合近3年来恩华药业的股价涨幅，能够看到其在周期下行中的受欢迎程度。 恩华药业与人福医药，是中国麻醉用药行业发展的见证者与推动者。其中，恩华药业前身为始建于1978年的徐州制药厂第三分厂。1999年，恩华药业完成第一次改制，次年又完成第二次改制，国有资本随后全部退出，公司实现从国有控股到由自然人股东和职工持股会共同出资组建的有限公司的转变；2008年，公司在深交所上市；2014年，恩华中枢药物研发中心启用，恩华研究院成立。 20世纪80年代末至90年代末，随着麻醉科成为一级临床科室，麻醉药品供应监管调整为“计划制”，麻醉学科和医药市场进入高速发展时段。2000年以来，麻醉药品监管由“计划制”调整为”备案制”，这为人福医药和恩华药业等企业的发展提供了更大的空间。 在此过程中，两家企业各自形成了在镇痛和镇静领域的主导性优势。随着瑞芬太尼和舒芬太尼的上市，人福医药在麻醉镇痛药领域稳坐“C位”；随着咪达唑仑1998年被恩华药业仿制后投入市场(商品名：力月西)，以及2002年依托咪酯仿制产品福尔利获批，恩华药业凭借这两款产品在镇静市场同样也占据了绝对的竞争优势。 与人福医药不同的是，恩华药业是国内唯一专注于中枢神经系统药物的上市企业，产品虽以麻醉类为核心，但同时还覆盖了精神类、神经类等全部中枢神经系统药物，包括精神分裂症、抑郁症、麻醉镇痛等领域药物，是国内中枢神经领域药物品种最多、品规最全的企业，同时也是国家定点麻醉类和精神类药品生产基地。 A股近500家医药类上市公司，营收及利润连续5年以上保持增长，且于2018年（含）上市的企业不到20家，其中便有恩华药业。近三年，恩华药业复合增长率约15%。 而如果与同在麻醉业务线上有交叉的恒瑞相比，恩华药业的毛利可谓“吊打”。2020-2023年，恩华药业整体毛利率和净利率分别维持在70%以上和20%以上，这确保了其有较好的盈利能力，也因此，恩华药业的抗风险和资产收益的能力均较强。过去5年时间，恩华药业的净资产收益率一直在15%水平之上，进一步佐证其盈利能力。 而高毛利主要得益于麻醉类业务，这一板块毛利率在近5年都维持在88%以上的水平。 2019年，恩华药业剥离掉部分医药商业公司股权，此后其麻醉药业务收入贡献逐年凸显，且毛利率整体以较稳的步调提升。 如今，恩华药业的营收构成主要包括医药工业、医药商业和其他业务，工业板块贡献超八成，其中，精神类药物约占总营收比重约20%，神经类业务体量整体较小，且受集采续约、竞争加剧等影响，增长将持续有所波动。整体来看，公司收入主力是麻醉类业务，占总营收比例超50%。 这一板块中，恩华药业具有两款竞争力十足的老产品：强效及短效镇静催眠药力月西（咪达唑仑）；非巴比妥类静脉短效催眠药福尔利（依托咪酯）。 咪达唑仑是一款具备超40年临床使用的老药，1998年被恩华仿制后投入市场，逐步形成市场垄断地位。作为二类精神药品，此前市场中出现了咪达唑仑滥用现象，但自今年7月1日起，咪达唑仑原料药和注射剂调整为第一类精神药品，开启更加严格的管理模式。 1996年，德国原研B.Braun公司依托咪酯乳状注射液在国内获批，2002年，恩华药业仿制产品福尔利上市，福尔利在10年后便占据了80%的市场份额，且竞争格局始终良好，后来原研厂商B.Braun的国内销售也交给了恩华药业代理。 迄今，咪达唑仑和依托咪酯竞争格局仍较良好，短期内咪达唑仑集采可能性较小；依托咪酯脂肪乳剂（长链）目前为恩华药业独家产品，无集采风险。 根据PDB样本医院数据，福尔利和力月西2023年分别实现收入2.6亿元和2.9亿元，同比增长分别为10%和48.8%，仍保持较高增速。 被动“守位”与主动出击 福尔利和力月西虽占据绝对的市场地位，但终究会面临竞争对手的冲击。能明显看到的是，恩华药业近两年真正的业绩亮点，在于其“主动出击”踏入镇痛领域的四款新晋重磅产品——“羟瑞舒阿”。 “羟瑞舒阿”，指的是羟考酮、瑞芬太尼、舒芬太尼、阿芬太尼，除了瑞芬太尼在10年前上市，剩下三款均在2020年及之后获批。 四款产品的放量较为迅速。 根据PDB数据，2023年羟考酮注射液实现收入0.73亿元、瑞芬太尼0.63亿元、舒芬太尼0.15亿元。其中，羟考酮注射液自上市后呈现逐个季度增长态势。 可以说，自2020年之后，恩华药业逐步深入了镇痛赛道。无一例外，新的业绩增长点，都动了镇痛界“大哥”人福医药的”蛋糕”。 人福医药早期产品便以“芬太尼系”为主，历经多年的沉淀，已经打造出瑞芬太尼、舒芬太尼、阿芬太尼等核心产品，典型应用场景为手术室内的麻醉镇痛。 在麻醉业务中，镇痛药的收入增速高于整个行业。浙商证券分析显示，2017-2022年，我国CNS药物市场规模复合增速为-0.98%，几乎停滞。从品种结构看，麻醉药和镇痛药同期市场规模复合增速达8.9%。其中镇痛药占比由2017年15.7%大增至2022年27.1%。另外，浙商证券预测，基于手术室内麻醉需求呈现刚需特性，叠加多元化使用场景拓展，麻醉镇痛成长确定性高。 因此在当下，恩华药业“杀入”镇痛药领域的势头与决心，较为强烈。 在战略上，恩华药业曾表示，未来几年将在麻醉重症领域重点加强新产品市场准入，尤其是“羟瑞舒阿”上。公司将持续推进营销队伍专业化建设，进一步根据产品管线特点优化细分销售架构，做到更加精细化的运作，全面促进产品销量提升。 销售费用能从一定程度上印证其战略落地力度。2019-2023年，恩华药业的销售费用占营收比例明显有所升高，且比例始终高于人福医药。2022年，恩华药业销售费用为16.55亿元，同比增加3.78%；2023年其销售费用达17.37亿元，同比增加4.96%；2024年上半年销售费用为8.3亿元，同比增幅为6.03%。 市场对“羟瑞舒阿”的预期是较乐观的。浙商证券预计，2022年至2025年，“羟瑞舒阿”销售收入复合增速有望达50%。 然而，即便“羟瑞舒阿”在初期快速放量，却仍旧需要一定的”爬坡期”，能否明显助力恩华药业2025年实现百亿元营收目标，仍就是个问题。最主要的，还得靠系列“基本盘”业务。 不过，恩华药业的“基本盘”，正面临竞争对手迭代产品的冲击。 最大的“威胁”便来自人福医药。 近年来，人福医药也开始向着镇静领域发力，一大关键性产品便是麻醉创新药（针对上市药品的结构优化和剂型改良）——瑞马唑仑。据了解，瑞马唑仑相较于咪达唑仑是同类更优产品，因瑞马唑仑代谢不依赖肝肾，长时间输注体内无蓄积，对肝肾的副作用较小。 值得注意的是，瑞马唑仑目前在国内的放量速度很快，且放量进度还将随着适应证的全部打开进一步提速，市场认为其有望成为十亿元级大品种。此外，苑东生物在去年也提交了瑞马唑仑的上市申请。 这对恩华药业核心大单品之一力月西，带来了非常直观的冲击。 另外，恩华药业另一大核心大单品福尔利，也难逃被替代的风险。 在镇静领域，丙泊酚与依托咪脂同为非巴比妥类静脉麻醉药，丙泊酚的迭代升级，会潜在影响依托咪脂的市场份额。2020年12月，海思科1类新药HSK3486乳状注射液（环泊酚）获批上市，适应证为消化道内镜诊断和治疗镇静和/或麻醉。该产品是海思科自研的1.1类创新药，是经典麻醉镇静药丙泊酚的改良型新药，其安全性、有效性显著高于丙泊酚。 这给福尔利带来了不小的压力。为了实现对丙泊酚的替代，恩华药业正依托福尔利改构，保留既有优点情况下，力图克服抑制肾上腺皮质功能的缺点（项目名为NH600001）。NH600001目前尚且处于临床III期，预计2024年下半年才递交临床申请。 另一面，恩华药业此前受集采等因素影响，其收入及利润增速有所下滑。虽然参与集采品种占总收入比例不大，且存量制剂集采影响在下降，但叠加多家仿制药企业的竞争威胁，唯有打造出新的大单品及不断丰富产品梯队，才是长久之计。 于是在近两年，恩华药业一面加大了研投，另一面，采取引进与合作的方式加快差异化产品管线布局。 去年4月，恩华药业1类创新药富马酸奥赛利定注射液获批上市，并成功在2023年年底通过国谈，纳入2023年医保目录。 2024年半年报显示，恩华药业在研项目超70个，研发投入为3.18亿元，同比增长13.03%。在创新药研发方面，共有20余个在研创新药项目；在重点仿制药产品研发及一致性评价方面，开展仿制药项目44个，有4个品种处在申报生产阶段，分别为地佐辛、氯硝西泮、普瑞巴林胶囊和拉考沙胺注射液。 在引进管线上，今年2月，恩华药业与梯瓦签署合作协议，后者将药品安泰坦的独家商业化权益（中国大陆地区）出售给恩华，约定在未来4年内完成20亿~25亿元的销售额。此前恩华药业还与丹麦灵北、BWH、BDX等签署协议，从而引进了多款产品。 自研加授权引入都能为恩华药业带来潜在增量和中长期增长动力。但回归眼下，面对即将到来的2025年，恩华能否实现百亿营收目标，仍要画一个问号。 参考资料： 华福证券《恩华药业：精麻龙头，创新驱动成长》 浙商医药《恩华药业深度：精麻新品放量，创新加速驱动》 一审| 黄佳 二审| 李芳晨 三审| 李静芝 精彩推荐 CM10 | 集采 | 国谈 | 医保动态 | 药审 | 人才 | 薪资 | 榜单 | CAR-T | PD-1 | mRNA | 单抗 | 商业化 | 国际化 ｜ 猎药人系列专题 | 出海 启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 医药界·E药经理人 | 中国医药手册 创新100强榜单 | 恒瑞 | 中国生物制药 | 百济 | 石药 | 信达 | 君实 | 复宏汉霖 ｜翰森 | 康方生物 | 上海医药 | 和黄医药 | 东阳光药 |  荣昌 | 亚盛医药 | 齐鲁制药 | 康宁杰瑞 | 贝达药业 | 微芯生物 | 复星医药 ｜再鼎医药｜亚虹医药 跨国药企50强榜单 | 辉瑞 | 艾伯维 | 诺华 | 强生 | 罗氏 | BMS | 默克 | 赛诺菲 | AZ | GSK | 武田 | 吉利德科学 | 礼来 | 安进 | 诺和诺德 | 拜耳 | 莫德纳 | BI | 晖致 | 再生元