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Chi-Med Reports 2018 Interim Results and Updates Shareholders on
Key Clinical Programs
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.
Fruquintinib made substantial progress through China New Drug Application ("NDA") process, aiming for approval and
launch for colorectal cancer ("CRC") this year; we also target to report Phase III top-line results for non-small cell lung cancer ("NSCLC") in Q4
Savolitinib has two registration studies underway, global Phase III in papillary renal cell carcinoma ("PRCC")
and China registration intent Phase II in MET exon 14 mutation/deletion NSCLC; also
Tagrisso /savolitinib combination studies in NSCLC indications are in planning, and set to start in late
2018 and early 2019;
Expansion of U.S. and international operations firmly underway, including recruitment of U.S. Chief Medical Officer and
Head of International Operations; and
Video webcast presentation at 9:00 a.m. BST and additional conference call at 9:00 a.m.
FINANCIAL HIGHLIGHTS
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.
Group revenue of $102.2 million (H1 2017: $126.6m).
Net loss attributable to Chi-Med of $32.7 million (H1 2017: net profit $1.7m).
Cash resources of $416.9 million at Group level as of June 30, 2018 ($479.6m as
of December 31, 2017), including cash and cash equivalents, short-term investments and unutilized bank facilities.
Innovation Platform: increased investment in Research and Development ("R&D") driven by initiation of new
trials and ongoing enrollment in existing Phase III programs
Consolidated revenue was $13.6 million mainly from service fee payments from AstraZeneca
AB (publ) ("AstraZeneca"), Eli Lilly & Company ("Lilly") and Nutrition Science Partners Limited ("NSP"), our 50/50 joint venture with Nestl Health Science S.A.
("Nestl ") (H1 2017: $22.7m, which included $9.5m in milestone payments from AstraZeneca and Lilly).
R&D expenses on an as adjusted (non-GAAP) basis increased to $66.7 million (H1 2017:
$37.5m), primarily driven by rapid expansion of operations and increased clinical trial expenses on all eight clinical drug candidates.
Net loss attributable to Chi-Med of $52.9 million (H1 2017: -$14.8m).
Commercial Platform: strong net income growth amid shift in revenue model and over-the-counter ("OTC")
logistics divestment
Total consolidated sales fell 15% to $88.6 million (H1 2017: $103.9m) due to the
implementation of the Two-Invoice System ("TIS") in China, a new government policy that has led to a shift in our revenue recognition for certain third-party drugs from gross sales consolidation to a
fee-for-service revenue model.
Total sales of non-consolidated joint ventures, on an as adjusted (non-GAAP) basis excluding the effects of the
divestment of certain non-core operations, up 21% to $271.7 million (H1 2017: $224.2m). Strong growth across main product categories.
Total consolidated net income attributable to Chi-Med, unaffected by the TIS implementation, up 19% to
$26.9 million (H1 2017: $22.7m), on an as adjusted (non-GAAP) basis which exclude one-time gains in H1 2017.
INNOVATION PLATFORM OPERATING HIGHLIGHTS
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")
FRESCO China Phase III in third-line CRC, potentially best-in-class in terms of both
efficacy and safety:
China NDA substantial progress towards approval: nearing the end of the
pre-approval inspection of manufacturing facilities stage of the NDA process, one of the last stages of the NDA process, and aiming to receive an approval in the second half of 2018;
JAMA publication: in June 2018, the full results were published in the Journal of the American
Medical Association ("JAMA"), which we believe to be the first China-based novel oncology therapy trial to be published in the JAMA, another landmark achievement.
Two further analyses of FRESCO data presented at the annual meeting of the American Society of Clinical Oncology
("ASCO") in June 2018: subgroup analysis by prior anti-VEGF or anti-EGFR target therapy showed that fruquintinib had clinically meaningful benefits regardless of prior target
therapy ("PTT") without observed cumulative toxicity; ad-hoc analysis of quality-adjusted time without symptoms or toxicity ("Q-TWiST") showed relative improvement of Q-TWiST with fruquintinib,
representing a potentially clinically important quality-of-life benefit for patients;
FALUCA China Phase III in third-line
NSCLC: completed enrollment of 527 patients; expect to reach median overall survival ("OS") endpoint maturity and report top-line results in late
FRUTIGA China Phase III in second-line gastric
cancer: recruiting for clinical study in combination with Taxol (paclitaxel) proceeding as planned,
with an interim analysis intended in 2019.
enrolling as planned and intending to complete at the end of 2018, which would allow us to explore multiple innovative combination studies of fruquintinib and other TKIs, chemotherapy
and immunotherapy agents in the U.S.
Savolitinib Highly selective TKI of mesenchymal epithelial transition factor ("c-MET") Global Phase III studies underway or in
In MET Exon 14 mutation/deletion first-line
NSCLC: while continuing to enroll patients in Phase II in China, we have reached an agreement with regulators regarding the conditions
under which the existing trial could be sufficient for an NDA submission in China.
In EGFR mutation-positive NSCLC, following ongoing encouraging data in the TATTON Phase Ib/II trials of combinations with
Tagrisso , AstraZeneca is proceeding to:
In third-generation EGFR TKI-refractory (principally second-line and third-line after
Tagrisso ) NSCLC: initiate the next stage of global clinical trials around the end of 2018;
In first-/second-generation EGFR TKI-refractory (principally second-line after
Iressa / Tarceva ) NSCLC: initiate the next stage of global clinical trials in early 2019.
SAVOIR global Phase III study in c-MET-driven PRCC enrolling patients at all sites now
following its initiation in June 2017.
PRCC molecular epidemiology study ("MES")
progressing: 200+ patient tissue-sample diagnostic analysis likely to yield data by end of 2018, which we hope will highlight for regulatory
authorities an unmet medical need in c-MET-driven PRCC.
CALYPSO Phase II combinations with
Imfinzi programmed death-ligand 1 ("PD-L1") inhibitor: enrolled rapidly in H1 2018 and may complete
enrollment in late 2018 and in mid-2019 in PRCC and clear cell renal cell carcinoma ("ccRCC") patients, respectively.
Sulfatinib Unique angio-immuno kinase inhibitor of VEGFR, fibroblast growth factor receptor ("FGFR") 1, and colony stimulating factor-1 receptor
Phase IIIs in neuroendocrine tumor
("NET"): enrollment continuing in the two Phase III studies in NET patients in China, with interim analysis expected for 2019; if results
are positive, this could potentially be our first novel drug candidate to be launched by our own commercial team.
U.S. Phase Ib/IIa expansion: enrolling pancreatic NET and biliary tract cancer ("BTC")
patients, following the completion of the U.S. dose escalation stage and based on preliminary efficacy and safety data observed in these two indications in China.
Further progress in early/proof-of-concept clinical trials, including:
Epitinib Phase Ib/II in EGFR gene amplified
glioblastoma: trial initiated in China in the first quarter of 2018 with epitinib, our unique EGFR inhibitor that has demonstrated the ability to
penetrate the blood-brain barrier.
HMPL-523 U.S. investigational new drug ("IND")
clearance: The U.S. Food and Drug Administration ("FDA") approved our highly selective spleen TKI ("Syk") to progress into clinical trials in
June 2018, which we plan to initiate in early 2019.
HMPL004-6599 Australia Phase I
initiated: proprietary botanical drug being developed by our 50/50 joint venture with Nestl initiated and completed the single
ascending dose study in the first half of 2018. Phase II enabling non-clinical studies are being initiated.
Expansion of U.S. and international operations, and recruitment of key personnel:
New office in New Jersey: U.S./ex-Asia operations expanded to support our unpartnered compounds through proof-of-concept, registration trials,
and market launch in territories outside of Asia.
Key personnel recruited, including the U.S. Chief Medical Officer and Head of International Operations.
Key potential pipeline milestones anticipated in the next 6-12 months
Third-generation (Tagrisso ) EGFR-TKI refractory, c-MET gene amplified, NSCLC (both second-line
and third-line): initiation of global study of savolitinib in combination with Tagrisso in this rapidly growing patient population.
First-/second-generation (Iressa /Tarceva ) EGFR-TKI