London: Friday, July 27, 2018: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) today announces its unaudited financial results for the six months ended June 30, 2018 and updates shareholders on key clinical programs.
The points below are selected financial data for the six months ended June 30, 2018. For more details, please refer to “Financial Review”, “Operations Review” and “Unaudited Condensed Consolidated Financial Statements” below.
Overall Group
Innovation Platform: increased investment in Research and Development (“R&D”) driven by initiation of new trials and ongoing enrollment in existing Phase III programs
Commercial Platform: strong net income growth amid shift in revenue model and over-the-counter (“OTC”) logistics divestment
The points below summarize some of the pipeline development highlights so far this year. For more details, please refer to “Operations Review – Innovation Platform” below.
Fruquintinib – Highly selective tyrosine kinase inhibitor (“TKI”) of vascular endothelial growth factor receptor (“VEGFR”) 1/2/3:
Savolitinib – Highly selective TKI of mesenchymal epithelial transition factor (“c-MET”) – Global Phase III studies underway or in planning:
Sulfatinib – Unique angio-immuno kinase inhibitor of VEGFR, fibroblast growth factor receptor (“FGFR”) 1, and colony stimulating factor-1 receptor (“CSF-1R”):
Further progress in early/proof-of-concept clinical trials, including:
Expansion of U.S. and international operations, and recruitment of key personnel:
Key potential pipeline milestones anticipated in the next 6-12 months
The points below summarize some of the operational and financial highlights of our Commercial Platform in the first half of 2018. For more details, please refer to “Operations Review — Commercial Platform” below.
Scaled, high-performance drug marketing and distribution platform covering ~300 cites/towns in China with approximately 3,400 sales personnel. Targeting multiple indications with many household-name brands:
Simon To, Chairman of Chi-Med, said: “Chi-Med continues to deliver on its clear strategy of developing its broad pipeline and cultivating and growing its capabilities in global drug discovery and development, while maintaining an over a decade-and-a-half long track record of earnings growth in its Commercial Platform.
During the first half of 2018, we have focused on navigating the China NDA process for fruquintinib, which we believe is now nearing completion. We are optimistic that we will see fruquintinib approved and launched by year end. We also look forward, around year end, to reporting the top-line results for the pivotal Phase III, the FALUCA study, of fruquintinib in third-line NSCLC in China.
Our collaboration with AstraZeneca continues to gather momentum, and we are currently enrolling registration studies in both kidney and lung cancer indications for savolitinib monotherapy. We are also in the process of planning and preparing to initiate multiple additional studies in lung and gastric cancers, which we believe may ultimately serve as registration studies.
Our un-partnered assets have also made good progress, with sulfatinib in two Phase III studies in China that could produce readout next year in NETs. In addition, we have worked with key opinion leaders and the regulatory authorities in China to agree on a Phase III pathway for epitinib and aim to initiate a pivotal study around year end. On our Syk, phosphoinositide 3-kinase delta (“PI3Kδ”) and FGFR compounds, all of which are in proof-of-concept, we have made meaningful progress in enrollment thereby acquiring a preliminary understanding of efficacy and safety for each compound. We expect to present some of these data at scientific conferences over the next twelve months.
We are now looking closely into multiple opportunities to combine our highly selective TKIs with both PD-1 and PD-L1 immunotherapy agents and will strive to make progress during the second half of 2018, via collaboration, in this very high potential arena.
We have expanded our U.S./ex-Asia operations, including our office in New Jersey, and continue to recruit seasoned talent to manage the progress of our unpartnered compounds through proof-of-concept, registration trials, and market launch in territories outside of Asia.
Chi-Med has a clear and ambitious aim to bring three of our drugs through approval over the next approximately three years. We believe we are adequately structured and resourced to support this aim. In the longer term, we intend to continue to emerge as a world-class innovator based in China, bringing our assets to both the China and global markets. We have confidence in our ability to achieve these aims.”
Use of Non-GAAP Financial Measures – References in this announcement to adjusted R&D expenses, adjusted consolidated net income attributable to Chi-Med from our Commercial Platform, adjusted consolidated operating profit from our Commercial Platform, adjusted consolidated net income attributable to Chi-Med from our Prescription Drugs business and adjusted revenue of HBYS and non-consolidated joint ventures are based on non-GAAP financial measures. Please see the “Use of Non-GAAP Financial Measures and Reconciliation” below for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures, respectively.
Our updated guidance for 2018, compared to the most recent guidance in our full year results announcement for the year ended December 31, 2017 dated March 12, 2018, includes a $20 million increase in expected full year Innovation Platform R&D expense to $130-140 million. This increase reflects a rise in clinical trial spending as well as broadening of organizational scale and new middle management share-based incentive grants. These costs are all driven by the heightened competitive environment in China biotech, resulting from the step-change increase interest and investment in the sector over the past two years. We make no other changes to the full year 2018 financial guidance as detailed below:
| Group Level: | 2018 Previous Guidance | 2018 Current Guidance | Adjustment |
| Consolidated revenue | $155-175m | $155-175m | None |
| Admin., interest & tax | $(16)-(18)m | $(16)-(18)m | None |
| Net loss [1] | $(19)-(52)m | $(39)-(72)m | $(20)m increase |
| Innovation Platform: | |||
| Consolidated revenue | $40-50m | $40-50m | None |
| Adjusted (non-GAAP) R&D expenses |
$(110)-(120)m | $(130)-(140)m | $(20)m increase |
| Net loss [1] | $(60)-(80)m | $(80)-(100)m | $(20)m increase |
| Commercial Platform: | |||
| Sales (consolidated) | $115-125m | $115-125m | None |
| Sales of non-consolidated JVs [2] |
$460-480m | $460-480m | None |
| Net income on an as adjusted (non-GAAP) basis excl. one-time gains [1] |
$41-43m | $41-43m | None |
| One-time gains [1] | $0-20m [3] | $0-20m [3] | None |
| Net income [1] | $41-63m | $41-63m | None |
Notes: [1] Attributable to Chi-Med; [2] Joint ventures; [3] One-time property compensation, timing of which is dependent on Guangzhou government policy.
Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products. Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.
Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 1). For more information, please visit: www.chi-med.com.
Mark Lee, Senior Vice President,
Corporate Finance & Development
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Anthony Carlisle, Citigate Dewe Rogerson
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Brad Miles, Solebury Trout
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David Dible, Citigate Dewe Rogerson
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Richard Gray / Andrew Potts
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Unless the context requires otherwise, references in this announcement to the “Group,” the “Company,” “Chi-Med,” “Chi-Med Group,” “we,” “us,” and “our,” mean Hutchison China MediTech Limited and its consolidated subsidiaries and joint ventures unless otherwise stated or indicated by context.
The performance and results of operations of the Group contained within this announcement are historical in nature, and past performance is no guarantee of future results of the Group. This announcement contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by words like “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “pipeline,” “could,” “potential,” “believe,” “first-in-class,” “best-in-class,” “designed to,” “objective,” “guidance,” “pursue,” or similar terms, or by express or implied discussions regarding potential drug candidates, potential indications for drug candidates or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that any of our drug candidates will be approved for sale in any market, or that any approvals which are obtained will be obtained at any particular time, or that any such drug candidates will achieve any particular revenue or net income levels. In particular, management’s expectations could be affected by, among other things: unexpected regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including the inability to meet our key study assumptions regarding enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria and funding requirements, changes to clinical protocols, unexpected adverse events or safety, quality or manufacturing issues; the inability of a drug candidate to meet the primary or secondary endpoint of a study; the inability of a drug candidate to obtain regulatory approval in different jurisdictions or gain commercial acceptance after obtaining regulatory approval; global trends toward health care cost containment, including ongoing pricing pressures; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, intellectual property disputes, and government investigations generally; and general economic and industry conditions, including uncertainties regarding the effects of the persistently weak economic and financial environment in many countries and uncertainties regarding future global exchange rates. For further discussion of these and other risks, see Chi-Med’s filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med is providing the information in this announcement as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.
In addition, this announcement contains statistical data and estimates that Chi-Med obtained from industry publications and reports generated by third-party market research firms. Although Chi-Med believes that the publications, reports and surveys are reliable, Chi-Med has not independently verified the data and cannot guarantee the accuracy or completeness of such data. You are cautioned not to give undue weight to this data. Such data involves risks and uncertainties and are subject to change based on various factors, including those discussed above.
Inside Information
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014.
Ends
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2018年7月23日：和黄中国医药科技（简称“和黄医药”或 “Chi-Med”）（纳斯达克/伦敦证交所：HCM）今日宣布在美国启动索凡替尼以胰腺神经内分泌瘤（NET）和胆管癌（BTC）为适应症的Ib/II期概念验证临床试验。索凡替尼是一种口服小分子血管免疫激酶抑制剂，可同时阻断肿瘤组织内的血管生成和肿瘤细胞的免疫逃逸。在这项研究启动之前，已有多项索凡替尼相关研究在中国开展，包括2项以胰腺和非胰腺NET为适应症的III期临床试验和1项以BTC为适应症的II期临床试验。其中，两项III期临床试验均是基于同一项II期临床试验的良好结果而开展的。此外，美国研究的I期剂量递增部分已于近期完成。
这项多中心单臂开放标签的概念验证研究旨在评估索凡替尼单药治疗（a）一线标准化疗后进展的晚期BTC患者以及（b）晚期胰腺NET患者的疗效和安全性。主要及次要研究终点包括无进展生存率（PFS）、客观缓解率（ORR）、疾病控制率（DCR）、缓解持续时间（DoR）、达到缓解时间、总生存期（OS）、安全性及耐受性。该研究详情可登录clinicaltrials.gov，检索NCT02549937查看。
索凡替尼是一种新型口服血管免疫激酶抑制剂，能够有效抑制与血管内皮生长因子受体（VEGFR）、成纤维细胞生长因子受体（FGFR）和集落刺激因子-1受体（CSF-1R）等靶点相关的酪氨酸激酶活性，这三种酪氨酸激酶受体均参与了肿瘤新生血管的生成以及免疫逃逸。通过抑制VEGFR信号通路能够阻断肿瘤组织周围过度的脉管系统的生成（血管生成），从而切断了肿瘤快速增长所需营养及氧气的供给。抗VEGFR疗法可能会加剧FGFR信号通路的异常激活，从而导致因肿瘤增长而产生的疾病进展、肿瘤周围的血管生成以及髓源抑制性细胞的形成。肿瘤相关巨噬细胞能够抑制机体针对肿瘤细胞的免疫应答，抑制CSF-1R信号通路可阻断肿瘤相关巨噬细胞的活化从而抑制肿瘤细胞的免疫逃逸。独特的血管免疫激酶抑制作用使得索凡替尼成为一种有潜力与检查点抑制剂联合治疗多种癌症的潜在候选药物。
索凡替尼是和黄医药自主完成在中国的概念验证试验，并扩展到美国进行临床研究的第一个肿瘤候选药物。目前，和黄医药正在开展6项索凡替尼针对不同目标患者的临床研究，并保留索凡替尼在全球的所有权利。
目前在中国，索凡替尼单药治疗NET、甲状腺癌或BTC患者的多项临床研究正在开展。
胰腺NET：2016年3月，和黄医药启动了一项随机双盲安慰剂对照的多中心关键性III期注册研究SANET-p，计划在中国招募约190例低级别或中级别晚期胰腺NET患者。主要研究终点为PFS，次要研究终点包括ORR、DCR、DoR、达到缓解时间、OS、安全性及耐受性。SANET-p研究详情可登录clinicaltrials.gov，检索NCT02589821查看。该研究预计将在2019年完成患者招募，随后将公布主要研究结果。
非胰腺NET：索凡替尼的SANET-ep临床试验于2015年12月启动，与SANET-p临床试验相似。该研究计划在中国招募约270例晚期非胰腺神经内分泌瘤患者。 SANET-ep研究详情可登录clinicaltrials.gov，检索NCT02588170查看。该研究预计将在2019年完成患者招募，随后将公布主要研究结果。
甲状腺癌：2016年3月，和黄医药在中国启动了2项分别以晚期甲状腺髓样癌患者或放射性碘难治性分化型甲状腺癌患者为目标受试者的II期临床试验，旨在评估索凡替尼的疗效和安全性。研究详情可登录clinicaltrials.gov，检索NCT02614495查看。
BTC：和黄医药于2017年1月启动了索凡替尼治疗胆管癌患者的II期临床研究。胆管癌起源于胆管上皮细胞，包括多种异质性的罕见恶性肿瘤。健择是目前已获批的治疗胆管癌的一线用药。根据美国国家癌症研究所数据，美国每年约有18000例新增胆管癌患者，然而，被确诊为不可切除或转移性胆管癌患者的中位生存期不到12个月。目前，健择治疗后进展的胆管癌患者的后续治疗仍存在很大的尚未满足的医学需求，索凡替尼也许能够为这类患者提供新的治疗选择。该研究详情可登录clinicaltrials.gov，检索NCT02966821查看。