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Chi-Med Reports 2019 Interim Results and Provides Updates on
Key Clinical Programs
London: Tuesday, July 30, 2019: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) today announces its unaudited financial results
for the six months ended June 30, 2019 and provides updates on key clinical programs. Major highlights include:
Positive surufatinib China Phase III study in non-pancreatic neuroendocrine tumors ("NET") Interim
analysis of SANET-ep study confirmed to have met primary endpoint and the Independent Data Monitoring Committee ("IDMC") recommended the study be un-blinded, a year ahead of schedule. New Drug
Application ("NDA") is now being prepared for submission during 2019;
Early progress on Elunate (fruquintinib capsules) with China in-market sales in colorectal cancer ("CRC")
of $11.4 million1 (RMB77.1 million) during H1 2019; Discussions in progress for potential inclusion in the China National Reimbursement Drug List ("NRDL") at
the next update in Q4 2019;
Potential for first savolitinib NDA targeted for H1 2020 for MET2 Exon 14 deletion non-small
cell lung cancer ("NSCLC") in China. Oral presentations of savolitinib data made at scientific conferences in H1 2019 in lung cancer (monotherapy and combination with Tagrisso ) and kidney
cancer (combination with Imfinzi ).
Video webcast presentation at 9:00 a.m. BST and additional conference call at 9:00 a.m. EDT.
business is progressing well on all fronts." said Simon To, Chairman, Chi-Med. "All major clinical readouts in the first half were encouraging, with the stand-out results being
surufatinib's positive Phase III outcome in non-pancreatic NET and savolitinib's preliminary data in MET Exon 14 deletion NSCLC along with the completion of enrollment of its registration
study. We believe these accomplishments have the potential to support Chi-Med's next two NDA submissions, surufatinib later this year and savolitinib early next year."
encouraging preliminary data was also reported for the savolitinib / Tagrisso combination in NSCLC, which led to the initiation of a global registration intent trial by
AstraZeneca AB (publ) ("AstraZeneca"), the SAVANNAH study, early this year. Also, recently released preliminary data for the savolitinib / Imfinzi combination in kidney cancer is
first approved oncology drug, Elunate , is making progress, with first six-month revenue well ahead, at the same stage, of the five small molecule VEGFR3 inhibitors
previously launched by multinational companies in China. In our view, with time and inclusion in the China NRDL, Elunate 's well documented efficacy and safety profile will make it a
formidable competitor."
figures for Elunate are based on information provided by Eli Lilly and Company ("Lilly");
epithelial transition receptor ("MET");
endothelial growth factor receptor ("VEGFR");
is as usual for our Commercial Platform, which generated 9% net income growth on a CER4 basis versus same period last year. This income helps significantly to fund our clinical
development programs as well as our discovery engine which produced yet another exciting oncology asset, our ninth, with the IND5 submission of our novel IDH 1/2
inhibitor6 HMPL-306."
organization is expanding rapidly, with our New Jersey-based international clinical and regulatory team scaling up to manage global registration studies on surufatinib and fruquintinib and early
development on our B-cell malignancy assets. Our in-house oncology commercial team in China is also growing fast, managing medical affairs and getting ready for the potential launch of surufatinib
ahead at the next two years, we expect to accelerate our transformation into a fully integrated and globally-facing biopharmaceutical company with capability to discover, develop and launch
multiple novel drug innovations aimed at addressing a broad range of unmet medical needs and benefiting a large number of patients."
FINANCIAL HIGHLIGHTS
items below are selected financial data for the six months ended June 30, 2019. All monetary figures are expressed in U.S. dollars unless otherwise stated. For more details, please refer to
"Financial Review", "Operations Review" and "Interim Unaudited Condensed Consolidated Financial Statements" below.
OVERALL GROUP: sufficient resources to reach multiple value inflection points on our pipeline
Group revenue $102.2 million (H1-18: $102.2m).
Net loss attributable to Chi-Med of $45.4 million (H1-18: net loss of $32.7m).
Adjusted Group net cash flows (non-GAAP) was -$63.7 million in H1 2019 including the
repayment of a total of $26.9 million in bank loans, leaving the Group with no outstanding bank borrowings. Cash from our Commercial Platform, as well as payments received from our
multinational partners, continued to offset a material part of our research and development ("R&D") expenses.
Cash resources of $383.6 million at Group level as of June 30, 2019
(December 31, 2018: $420.3m), including cash, cash equivalents and short-term investments of $237.3 million (December 31, 2018: $301.0m) and unutilized bank facilities of
$146.3 million (December 31, 2018: $119.3m).
INNOVATION PLATFORM: increased investment in R&D driven by expansion of our organization, operations and
progress on our clinical development pipeline
Consolidated revenue was $12.0 million (H1-18: $13.6m) mainly due to payments from
AstraZeneca and Lilly. During H1 2019, following the launch of Elunate in late 2018, we recorded $5.5 million (H1-18: $1.1m) in manufacturing and service fee revenues as well as
royalty income from Lilly.
[4] Constant Exchange
Rate ("CER"). Certain financial information in this announcement is presented on a constant exchange rate basis, or at CER. These financial measures are not prepared in accordance with U.S. generally
accepted accounting principles (GAAP) because they remove the effects of currency movements from our reported results. Please refer to "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;
dehydrogenase ("IDH") 1 and 2;
R&D expenses on an as adjusted (non-GAAP) basis increased to $74.5 million (H1-18:
$66.7m), primarily driven by the progress in the development of our eight clinical drug candidates, five of which are either in or about to start development outside China; the ramp-up of our small
molecule manufacturing operations in Suzhou; expansion of U.S. and international clinical and regulatory operations; and establishment of our oncology commercial infrastructure in China.
Net loss from our Innovation Platform attributable to Chi-Med of $63.8 million (H1-18:
net loss of $52.9m).
COMMERCIAL PLATFORM: solid net income growth on a CER basis due to continued progress in our Prescription
Total consolidated sales grew 2% (7% at CER) to $90.2 million (H1-18: $88.6m) mainly due
to progress on our Prescription Drugs subsidiary Hutchison Sinopharm7 being partially offset by rationalization of certain low contribution products in the Consumer Health business.
Total sales of non-consolidated joint ventures increased 2% (8% at CER) to
$276.9 million (H1-18: $271.7m) driven by solid performance on our leading prescription cardiovascular drug, She Xiang Bao Xin ("SXBX") pill, which grew 9% (15% at CER)
to $141.0 million (H1-18: $129.8m).
Total consolidated net income from our Commercial Platform attributable to Chi-Med increased 3% (9% at CER) to
$27.7 million (H1-18: $26.9m).
U.K. Analysts Meeting and Webcast Scheduled Today at 9:00 a.m. BST (4:00 p.m. HKT) at Citigate Dewe Rogerson,
8th Floor, Holborn Gate, 26 Southampton Buildings, London WC2A 1AN, UK. Investors may participate in the call at +44 20 3003 2666 (800 900 476 toll free in Hong
Kong), or access a live video webcast of the call via Chi-Med's website at www.chi-med.com/investors/event-information/.
U.S. Conference Call Scheduled Today at 9:00 a.m. EDT to participate in the call from the U.S., please dial
dial-in numbers are also available at Chi-Med's website. For both calls please use conference ID "Chi-Med."
OPERATING HIGHLIGHTS
points below summarize some of Chi-Med's operating highlights so far this year. For more details, please refer to "Operations Review" below.
SURUFATINIB (HMPL-012 or sulfatinib) angio-immuno kinase inhibitor of VEGFR 1/2/3, fibroblast growth factor receptor ("FGFR") 1, and colony stimulating factor-1
receptor ("CSF-1R"):
Positive China Phase III in non-pancreatic
NET: An interim analysis in June 2019 confirmed that the Phase III non-pancreatic NET (SANET-ep) study met its primary endpoint of
progression-free survival ("PFS"). As a result, the IDMC recommended the study be un-blinded, a year ahead of schedule, and preparations are now underway for an NDA submission in late 2019 for this
indication in China;
Initiated China Phase II/III in biliary tract cancer
("BTC"): Based on preliminary Phase Ib/IIa data, we initiated a Phase IIb/III registration study in BTC in China in March 2019; and
[7] Hutchison Whampoa
Sinopharm Pharmaceuticals (Shanghai) Company Limited ("Hutchison Sinopharm").
Initiated PD-1 combination
development: Received China IND clearance during early 2019 and initiated a Phase I safety run-in study in China of surufatinib plus
Tuoyi , an approved PD-1 monoclonal antibody from Shanghai Junshi Biosciences Co. Ltd. ("Junshi").
FRUQUINTINIB highly selective tyrosine kinase inhibitor ("TKI") of VEGFR 1/2/3 potential best-in-class in terms of both efficacy and
Early progress on Elunate (fruquintinib capsules) in third-line CRC in
$11.4 million (RMB77.1 million) in sales during H1 2019: In-market
sales of Elunate to third-parties, as provided by Lilly, in the first full six-month period since its November 25, 2018 launch;
Progress in reimbursement discussion: Elunate was included in the
Shanghai provincial reimbursement drug list ("RDL") in June 2019. Discussions now in-progress for potential inclusion in the China NRDL at the next update in early Q4 2019.
Cleared Phase III interim analysis in second-line gastric
cancer: In April 2019, we conducted an interim analysis of the FRUTIGA study in China for futility. The analysis evaluated PFS and overall
survival ("OS") trends after six months of therapy for the first 100 patients in the study. The IDMC recommended to continue the study without changes; and
Initiated PD-1 combination
development: Received China IND clearance in early 2019 and initiated a Phase I study of fruquintinib plus Tyvyt , an approved
PD-1 monoclonal antibody from Innovent Biologics (Suzhou) Co. Ltd. ("Innovent"). Phase I development of fruquintinib plus genolimzumab, a PD-1 monoclonal antibody under