Hong Kong, Shanghai & Florham Park, NJ: Thursday, July 30, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM), an innovation-driven, commercial-stage biopharmaceutical company, today announces its unaudited financial results for the six months ended June 30, 2020 and provides updates on key clinical and commercial developments.
“During the first half of 2020, we continued to build our fully integrated business in China, from research and development to manufacturing and commercialization and sales, with a focus on oncology,” said Mr. Simon To, Chairman of Chi-Med. “NDAs for surufatinib and savolitinib are currently under review by the China NMPA6 and we are now preparing for multiple potential launches employing our newly-established commercial organization in oncology, covering all provinces in Mainland China.”
“We are also one of a few China-based biotech companies working to realize the global potential of our home-grown innovative drug candidates,” he added. “We currently have nine novel drug candidates in clinical trials, many with global potential, and an additional five drug candidates at the IND7-enabling stage.”
“Over the past three years, we have significantly expanded our international development footprint and, in the first half of 2020, locked in global registration strategies for surufatinib and fruquintinib, while our global partnership with AstraZeneca8 is approaching the same for savolitinib. A deep pipeline of unpartnered earlier-stage oncology assets follows, with most notably, global development of our Syk9 and PI3Kδ10 assets progressing well and our IDH 1/211 inhibitor expected to start Phase I in the United States this year.”
“We believe that the anticipated launches of multiple innovative oncology drugs over the next twelve to eighteen months will address a broad range of unmet medical needs and benefit a large number of patients globally, propelling Chi-Med into a new phase of growth.”
FIRST HALF 2020 OPERATING HIGHLIGHTS
Set out below are some of Chi-Med’s operating highlights so far this year. For more details, please refer to “Operations Review” below.
I. PREPARING TO LAUNCH MULTIPLE ONCOLOGY DRUGS IN CHINA
Savolitinib – NDA submitted for potential first-in-class selective MET TKI12 in China:
Surufatinib – Two NDAs with first China launch in NET planned for late 2020:
Fruquintinib – Commercial progress on Elunate® (fruquintinib capsules):
Established in-house oncology commercial organization – Team now in place for imminent launches:
II. REALIZING THE GLOBAL POTENTIAL OF OUR LATE STAGE ONCOLOGY ASSETS
Surufatinib – U.S. NDA under preparation:
Fruquintinib – global Phase III registration study in CRC28 underway:
Savolitinib – AstraZeneca collaboration making progress in lung and kidney cancer:
III. INVESTING IN THE FUTURE – EARLY PIPELINE
IV. UPDATE ON THE IMPACT OF COVID-19
KEY EVENTS PLANNED FOR BALANCE 2020 & EARLY 2021
|CHINA EVENTS: A FULLY INTEGRATED ONCOLOGY BUSINESS IN CHINA|
· Elunate® China commercialization – Chi-Med to assume medical detailing and marketing activities for Elunate® in all China on October 1, 2020; and
· Enrollment completion of FRUTIGA Phase III – complete enrollment of China registration study in second-line gastric cancer.
· Presentation of SANET-p Phase III data – pancreatic NET patients study at ESMO37 2020 conference;
· Acceptance of NDA in pancreatic NET – following recent NDA submission based on positive SANET-p Phase III interim analysis;
· Phase II/III interim analysis – for futility in second-line BTC38 in China; and
· Potential NDA approval and launch for non-pancreatic NET – first un-partnered oncology drug launch for Chi-Med in China.
|Savolitinib||· Potential NDA approval and launch for NSCLC – monotherapy in MET Exon 14 skipping mutation NSCLC. If approved, this will be the first approval worldwide and the first selective c-MET TKI approval in China. Material milestone triggering event.|
· HMPL-689 (PI3Kδ) Phase I/Ib NHL data – potential presentation of China data at major scientific conference;
· HMPL-689 (PI3Kδ) – Potential registration study start – in indolent NHL in China;
· HMPL-523 (Syk) – Potential registration study start – in indolent NHL in China; and
· HMPL-523 (Syk) – completion of dose escalation in ITP39.
|GLOBAL EVENTS: REALIZING THE GLOBAL POTENTIAL OF OUR ONCOLOGY ASSETS|
· Global Phase III study (FRESCO-2) – expansion of registration study in CRC in 10 countries including the U.S., Europe and Japan; and
· Presentation of U.S. Phase Ib data – preliminary data from study of third and later line CRC patients at ESMO 2020 conference.
|Surufatinib||· U.S. NDA submission for pancreatic- and non-pancreatic NET – U.S. NDA rolling submission beginning in late 2020 through early 2021.|
· Internal interim analyses on SAVANNAH – Complete the review of the first internal interim analysis and conduct further interim analysis to inform regulatory strategy;
· Potential endorsement of global Phase III in kidney cancer – savolitinib monotherapy in MET-driven PRCC;
· Potential endorsement of global Phase III in NSCLC – Tagrisso® combination in EGFRm40 positive, MET positive, NSCLC. Material milestone triggering event;
· Potential endorsement of global registration study in NSCLC – savolitinib in MET Exon 14 skipping mutation NSCLC; and
· Enrollment completion of SAVANNAH – AstraZeneca to complete enrollment of Phase II study, with registration potential, of savolitinib/Tagrisso® combination.
· HMPL-523 (Syk) – Global Phase Ib expansion – in indolent NHL in the U.S. and Europe;
· HMPL-306 (IDH 1/2) – U.S. IND submission and initiation of Phase I; and
· HMPL-689 (PI3Kδ) – Global Phase Ib expansion – in indolent NHL in the U.S. and Europe.
The items below are selected financial data for the six months ended June 30, 2020. All dollars are expressed in U.S. dollar currency unless otherwise stated. For more details, please refer to “Financial Review”, “Operations Review” and “Interim Unaudited Condensed Consolidated Financial Statements” below.
During the first half of 2020, we performed in-line with published guidance, with dividends from our Commercial Platform offsetting a material portion of our R&D expenses as expected.
Over the balance of 2020, cash investments will rise in a number of areas including: several major global clinical and regulatory activities such as the global FRESCO-2 Phase III for fruquintinib and the submission of the U.S. NDA for surufatinib; the first phase of construction of our new large-scale oncology manufacturing facility in Shanghai; and expansion of our commercial activities in oncology in China, specifically our new commercial role on Elunate® and preparation for the surufatinib launch.
We assume at this stage that the financial impact of the COVID-19 outbreak will not be material to the Group. Since we cannot predict how the situation will evolve, we will monitor and adjust if needed, as new material information emerges. We therefore provide unchanged Financial Guidance for 2020 below.
|Adjustments vs. Previous Guidance|
|Adjusted (non-GAAP) Innovation Platform segment operating loss||$(81.2) million||$(180) – (210) million||nil|
|Adjusted (non-GAAP) Group net cash flows excluding financing activities||$(32.5) million||$(140) – (160) million||nil|
Use of Non-GAAP Financial Measures and Reconciliation – References in this announcement to adjusted Innovation Platform segment operating loss, 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, respectively.
Conference Call and Audio Webcast Presentation Scheduled Today at 1 p.m. BST / 8 a.m. EDT / 8 p.m. HKT – Investors may participate in the call as follows: +44 20 3194 0569 (U.K.) / +1 646 722 4977 (U.S.) / +852 3027 6500 (Hong Kong), or access a live audio webcast of the call via Chi-Med’s website at www.chi-med.com/investors/event-information/.
Additional dial-in numbers are also available at Chi-Med’s website. Please use participant access code “54962123#.”
Chi-Med (Nasdaq/AIM: HCM) is an innovative, commercial-stage, biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has a portfolio of nine cancer drug candidates currently in clinical studies around the world and extensive commercial infrastructure in its home market of China. For more information, please visit: www.chi-med.com.
|Mark Lee, Senior Vice President||+852 2121 8200|
|Annie Cheng, Vice President||+1 (973) 567 3786|
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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,” “first-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 impact of the COVID-19 pandemic or other health crises in China or globally; 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.
REFERENCES AND ABBREVIATIONS