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
+852 2121 8200
Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
Brad Miles, Solebury Trout
+1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
Susan Duffy, Solebury Trout
+1 (917) 499 8887 (Mobile)
sduffy@troutgroup.com
Xuan Yang, Solebury Trout
+1 (415) 971 9412 (Mobile)
xyang@troutgroup.com
David Dible, Citigate Dewe Rogerson
+44 7967 566 919 (Mobile)
david.dible@citigatedewerogerson.com
Richard Gray / Andrew Potts
+44 (20) 7886 2500
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
| Announcement released: 7am BST (2pm HKT/2am EDT) |
| >> See announcement here |
| Presentation webcast & call: 9am BST (4pm HKT/4am EDT) |
| >> Click here for the webcast |
| US conference call: 9am EDT (2pm BST/9pm HKT) |
| — |
To participate by phone, please use one of the following numbers. The conference ID for the calls is “Chi-Med“.
| UK Toll Free | 808 109 0700 |
| USA Toll Free | 1 866 966 5335 |
| China Toll Free | 4001 200558 |
| Hong Kong Toll Free | 800 900 476 |
| Italy Toll Free | 800 986 477 |
| Singapore Toll Free | 800 120 4789 |
| Switzerland Toll Free | 0800 800 038 |
| New York City Local Access | +1 212 999 6659 |
| London/Other International | +44 20 3003 2666 |
2018年7月23日：和黃中國醫藥科技（簡稱「和黃醫藥」或「Chi-Med」）（納斯達克/倫敦證交所：HCM）今日宣佈在美國啟動索凡替尼以胰腺神經內分泌瘤（NET）和膽管癌（BTC）為適應症的Ib/II期概念驗證臨床試驗。索凡替尼是一種口服小分子血管免疫激酶抑製劑，可同時阻斷腫瘤組織內的血管生成和腫瘤細胞的免疫逃逸。在這項研究啟動之前，已有多項索凡替尼相關研究在中國開展，包括2項以胰腺和非胰腺NET為適應症的III期臨床試驗和1項以BTC為適應症的II期臨床試驗。其中，兩項III期臨床試驗均是基於同一項II期臨床試驗的良好結果而開展的。此外，美國研究的I期劑量遞增部分已於近期完成。
這項多中心單臂開放標籤的概念驗證研究旨在評估索凡替尼單藥治療（a）一線標準化療後進展的晚期BTC患者以及（b）晚期胰腺NET患者的療效和安全性。主要及次要研究終點包括無進展生存率（PFS）、客觀緩解率（ORR）、疾病控制率（DCR）、緩解持續時間（DoR）、達到緩解時間、總生存期（OS）、安全性及耐受性。該研究詳情可登錄clinicaltrials.gov，檢索NCT02549937查看。
索凡替尼是一種新型口服血管免疫激酶抑製劑，能夠有效抑制與血管內皮生長因子受體（VEGFR）、成纖維細胞生長因子受體（FGFR）和集落刺激因子-1受體（CSF- 1R）等靶點相關的酪氨酸激酶活性，這三種酪氨酸激酶受體均參與了腫瘤新生血管的生成以及免疫逃逸。通過抑制VEGFR信號通路能夠阻斷腫瘤組織周圍過度的脈管系統的生成（血管生成），從而切斷了腫瘤快速增長所需營養及氧氣的供給。抗VEGFR療法可能會加劇FGFR信號通路的異常激活，從而導致因腫瘤增長而產生的疾病進展、腫瘤周圍的血管生成以及髓源抑制性細胞的形成。腫瘤相關巨噬細胞能夠抑制機體針對腫瘤細胞的免疫應答，抑制CSF-1R信號通路可阻斷腫瘤相關巨噬細胞的活化從而抑制腫瘤細胞的免疫逃逸。獨特的血管免疫激酶抑製作用使得索凡替尼成為一種有潛力與檢查點抑製劑聯合治療多種癌症的潛在候選藥物。
索凡替尼是和黃醫藥自主完成在中國的概念驗證試驗，並擴展到美國進行臨床研究的第一個腫瘤候選藥物。目前，和黃醫藥正在開展6項索凡替尼針對不同目標患者的臨床研究，並保留索凡替尼在全球的所有權利。
目前在中國，索凡替尼單藥治療NET、甲狀腺癌或BTC患者的多項臨床研究正在開展。
胰腺NET：2016年3月，和黃醫藥啟動了一項隨機雙盲安慰劑對照的多中心關鍵性III期註冊研究SANET-p，計劃在中國招募約190例低級別或中級別晚期胰腺NET患者。主要研究終點為PFS，次要研究終點包括ORR、DCR、DoR、達到緩解時間、OS、安全性及耐受性。 SANET-p研究詳情可登錄clinicaltrials.gov，檢索NCT02589821查看。該研究預計將在2019年完成患者招募，隨後將公佈主要研究結果。
非胰腺NET：索凡替尼的SANET-ep臨床試驗於2015年12月啟動，與SANET-p臨床試驗相似。該研究計劃在中國招募約270例晚期非胰腺神經內分泌瘤患者。 SANET-ep研究詳情可登錄clinicaltrials.gov，檢索NCT02588170查看。該研究預計將在2019年完成患者招募，隨後將公佈主要研究結果。
甲狀腺癌：2016年3月，和黃醫藥在中國啟動了2項分別以晚期甲狀腺髓樣癌患者或放射性碘難治性分化型甲狀腺癌患者為目標受試者的II期臨床試驗，旨在評估索凡替尼的療效和安全性。研究詳情可登錄clinicaltrials.gov，檢索NCT02614495查看。
BTC：和黃醫藥於2017年1月啟動了索凡替尼治療膽管癌患者的II期臨床研究。膽管癌起源於膽管上皮細胞，包括多種異質性的罕見惡性腫瘤。健擇是目前已獲批的治療膽管癌的一線用藥。根據美國國家癌症研究所數據，美國每年約有18000例新增膽管癌患者，然而，被確診為不可切除或轉移性膽管癌患者的中位生存期不到12個月。目前，健擇治療後進展的膽管癌患者的後續治療仍存在很大的尚未滿足的醫學需求，索凡替尼也許能夠為這類患者提供新的治療選擇。該研究詳情可登錄clinicaltrials.gov，檢索NCT02966821查看。