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:
Video webcast presentation at 9:00 a.m. BST and additional conference call at 9:00 a.m. EDT.
“Chi-Med’s 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.”
“Highly 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 promising.”
“Our 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.”
“Business 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.”
“Our 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 late next year.”
“Looking 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.”
The 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
INNOVATION PLATFORM: increased investment in R&D driven by expansion of our organization, operations and progress on our clinical development pipeline
COMMERCIAL PLATFORM: solid net income growth on a CER basis due to continued progress in our Prescription Drugs business
The 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”):
FRUQUINTINIB – highly selective tyrosine kinase inhibitor (“TKI”) of VEGFR 1/2/3 – potential best-in-class in terms of both efficacy and safety:
SAVOLITINIB – potential first-in-class selective MET inhibitor in late-stage clinical development:
Further progress in early/proof-of-concept clinical trials and discovery, including:
Major organizational expansion, including:
|China – H2 2019||Global – H2 2019|
|1. Savolitinib – Registration study completion – MET Exon 14 deletion NSCLC (occurred July);||1. HMPL-523 (Syk) – Phase I – Initiate U.S. / E.U. Phase I/Ib in indolent NHL;|
|2. Surufatinib – Phase III data (SANET-ep) –presentation at scientific conference;||2. HMPL-689 (PI3Kδ) – Phase I – Initiate U.S. / E.U. Phase I/Ib in indolent NHL;|
|3. Surufatinib – NDA submission – in non-pancreatic NET;||3. Savolitinib – Phase II data (VIKTORY) – gastric cancer data (patient tumor molecular profiling).|
|4. Fruquintinib – Phase III data (FALUCA) – submit for presentation in NSCLC at conference;|
|5. Fruquintinib – Reimbursement – possible Elunate® inclusion in China NRDL in Q4 2019.|
|China – H1 2020||Global – H1 2020|
|6. Fruquintinib – Phase III interim analysis (FRUTIGA) – 2nd interim in gastric cancer;||4. Surufatinib – Phase II/III start – initiate U.S. / E.U. study in pancreatic NET;|
|7. Surufatinib – Phase III interim analysis (SANET-p) – planned final interim analysis;||5. Fruquintinib – Phase II/III start – initiate U.S. / E.U. Phase II/III study in metastatic CRC;|
|8. Savolitinib – NDA submission – in MET Exon 14 deletion NSCLC;||6. Savolitinib – Phase II data (CALYPSO) – Imfinzi® (PD-L1) combo in RCC;|
|9. Surufatinib – Phase Ib/II data – submit for presentation of BTC at conference;||7. Savolitinib – Phase II registration study (SAVANNAH) interim analysis – in NSCLC;|
|10. HMPL-523 – Phase II study start – potential registration study indolent NHL.|
We are providing the following updated Financial Guidance for the year ending December 31, 2019. Our updated guidance takes into account the weakening of the RMB, which was down 6% against the U.S. dollar during H1 2019 (using the average exchange rate for the period) relative to the same period last year due to global macroeconomic factors. We expect this trend to continue through the balance of 2019, and this depreciation of the RMB has the effect of reducing our R&D expenses in China in U.S. dollar terms.
In addition, we have both expanded and extended existing studies of surufatinib and fruquintinib in the U.S. ahead of upcoming regulatory authority end of Phase II meetings. This will move certain start-up costs of our global Phase II/III registration studies on surufatinib and fruquintinib into 2020.
|2019 Previous Guidance||2019 Current Guidance||Adjustments|
|Adjusted R&D Expenses||$(160) – (200) million||$(130) – (170) million||$(30) million|
|Adjusted Group Net Cash Flows excluding financing activities||$(120) – (150) million||$(90) – (120) million||$(30) million|
Use of Non-GAAP Financial Measures – References in this announcement to adjusted R&D expenses, adjusted Group net cash flows and adjusted Group net cash flows excluding financing activities and financial measures reported at CER 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.
Chi-Med (AIM/Nasdaq: HCM) is an innovative biopharmaceutical company which researches, develops, manufactures and markets pharmaceutical products. Its Innovation Platform, Hutchison MediPharma, has about 440 scientists and staff focusing on discovering, developing and commercializing targeted therapies and immunotherapies in oncology and autoimmune diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world. Chi-Med’s Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products, covering an extensive network of hospitals across China.
Chi-Med is headquartered in Hong Kong and is dual-listed on the AIM market of the London Stock Exchange and the Nasdaq Global Select Market. For more information, please visit: www.chi-med.com.
Mark Lee, Senior Vice President, Corporate Finance & Development
+852 2121 8200
Annie Cheng, Vice President, Corporate Finance & Development
+1 (973) 567 3786
David Dible, Citigate Dewe Rogerson
+44 7967 566 919 (Mobile)
Xuan Yang, Solebury Trout
+1 (415) 971 9412 (Mobile)
UK & Europe – Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
Americas – Brad Miles, Solebury Trout
+1 (917) 570 7340 (Mobile)
Hong Kong & Asia ex-China – Joseph Chi Lo, Brunswick
+852 9850 5033 (Mobile)
Hong Kong & Asia ex-China – Zhou Yi, Brunswick
+852 9783 6894 (Mobile)
Mainland China – Sam Shen, Edelman
+86 1367 179 1029 (Mobile)
Richard Gray / Atholl Tweedie, Panmure Gordon (UK) Limited
+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, a potential SEHK listing and concurrent global offering of our securities 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.
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014.