Oncology/Immunology revenues up 296% to $119.6 million, due to ELUNATE® growth and the 2021 launches of SULANDA® and ORPATHYS®;
Positive SAVANNAH, CALYPSO and VIKTORY studies triggered five registration studies on ORPATHYS® in lung cancer, kidney and gastric cancer during 2021;
Broad late-stage development program – currently enrolling 13 registration studies on 6 assets – with enrollment on the 691 patient FRESCO-2 global Phase III of fruquintinib now complete.
Company to Host Annual Results Call & Webcast Today
at 9 p.m. HKT / 1 p.m. GMT / 8 a.m. EST
Hong Kong, Shanghai & Florham Park, NJ — Thursday, March 3, 2022: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13), the innovative, commercial-stage biopharmaceutical company, today reports its audited financial results for the year ended December 31, 2021 and provides updates on key clinical and commercial developments since the start of 2022.
All amounts are expressed in U.S. dollars unless otherwise stated.
“2021 was an exceptional year for HUTCHMED,” said Mr. Simon To, Chairman of HUTCHMED. “Commercial success on ELUNATE® and the launches of SULANDA® and ORPATHYS® contributed to an almost four-fold increase in consolidated oncology/immunology revenues to $119.6 million, with momentum continuing in 2022.
ORPATHYS® took a major step forward in 2021 with its first approval and important, and as yet unpublished, data from the SAVANNAH study in combination with TAGRISSO®. We and our partner AstraZeneca[1] initiated four Phase III studies and one Phase II study, with registration potential, for ORPATHYS® during 2021. These actions have triggered $40 million in milestone payments to HUTCHMED since mid-2021. A seventh registration study, a global Phase III in NSCLC[2], the SAFFRON study, is set to initiate in mid-2022.
We are rapidly progressing our plan to expand our oncology assets into global markets. Led by our team of over 800-personnel in discovery, development and manufacturing operations, we have an un-equaled fifteen-year track-record of producing highly quality novel oncology/immunology drug candidates.
Seven of our assets are now being developed outside China. In addition to the global progress of ORPATHYS®, surufatinib’s U.S. NDA[3] and EU MAA[4] are in the later stages of regulatory review for advanced NETs; enrollment was completed for fruquintinib in a fourteen-country global Phase III study, the FRESCO-2 study, in CRC[5] which reads-out later in 2022; positive and differentiated POC data was presented for amdizalisib and sovleplenib; and our FGFR[6], IDH1/2[7], ERK[8], third generation BTK[9] and CSF-1R[10] inhibitors all made good progress in early development.
With a strong track record in bringing innovative drugs to patients through rigorous clinical trials, our seasoned clinical team is now enrolling 13 registration studies for six assets with an additional 5 registration studies set to initiate in 2022. With over $1 billion in cash, and the intention to divest further non-core assets, we anticipate having sufficient runway to see our plans through.
Our strategy is to launch a stream of new products in both the China and global markets over the coming years, helping patients with unmet needs and creating value for all our stakeholders.”
| (Growth vs. Prior Period) | In-market Sales* | Consolidated Revenue** | ||||||
| 2021 | Jan-Feb 2022 Unaudited |
2021 | Jan-Feb 2022 Unaudited |
|||||
| ELUNATE® | $71.0m | (111%) | $21.6m | (51%) | $53.5m | (168%) | $13.5m | (33%) |
| SULANDA® | $11.6m | – | $6.0m | (21%) | $11.6m | – | $6.0m | (21%) |
| ORPATHYS® | $15.9m | – | $7.4m | – | $11.3m | – | $4.8m | – |
| Product Sales | $98.5m | (192%) | $35.0m | (81%) | $76.4m | (282%) | $24.3m | (61%) |
| Other R&D[14] Service income | $18.2m | (77%) | $3.7m | (80%) | ||||
| Milestone payments | $25.0m | – | $15.0m | – | ||||
| Total Oncology/ Immunology | $119.6m | (296%) | $43.0m | (151%) | ||||
| * = For ELUNATE® and ORPATHYS®, represents total sales to third parties as provided by Lilly and AstraZeneca, respectively; ** = For ELUNATE® and ORPATHYS®, represents manufacturing fees, commercial service fees and royalties paid by Lilly and AstraZeneca, respectively, to HUTCHMED, and sales to other third parties invoiced by HUTCHMED; For SULANDA®, represents the Company’s sales of the product to third parties. |
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Savolitinib (ORPATHYS®), a highly selective oral inhibitor of MET being developed broadly across MET-driven patient populations in lung and gastric cancer and renal cell carcinoma
Major clinical milestones for savolitinib in 2021:
Major savolitinib clinical data presentations in 2021:
Potential upcoming clinical and regulatory milestones for savolitinib in 2022:
Surufatinib (SULANDA® in China), an oral inhibitor of VEGFR[25], FGFR and CSF-1R designed to inhibit tumor angiogenesis and promote the body’s immune response against tumor cells via tumor associated macrophage regulation; approved and launched in China
Major clinical milestones for surufatinib in 2021:
Major surufatinib clinical data presentations in 2021:
Potential upcoming clinical and regulatory milestones for surufatinib in 2022:
Fruquintinib (ELUNATE® in China), a highly selective oral inhibitor of VEGFR 1/2/3 designed to improve kinase selectivity to minimize off-target toxicity and thereby improve tolerability; approved and launched in China
Major clinical milestones for fruquintinib in 2021:
Major fruquintinib clinical data presentations in 2021:
Potential upcoming clinical and regulatory milestones for fruquintinib in 2022:
Amdizalisib (HMPL-689), an investigative and highly selective oral inhibitor of PI3Kδ[39] designed to address the gastrointestinal and hepatotoxicity associated with currently approved and clinical-stage PI3Kδ inhibitors
Major clinical milestones for amdizalisib in 2021:
Major amdizalisib clinical data presentation in 2021:
Potential upcoming clinical and regulatory milestones for amdizalisib in 2022:
Sovleplenib (HMPL-523), an investigative and highly selective oral inhibitor of Syk[41], an important component of the B-cell receptor signaling pathway, for the treatment of hematological cancers and immune diseases
Major clinical and regulatory milestones for sovleplenib in 2021:
Major sovleplenib clinical data presentations in 2021:
Potential upcoming clinical milestone for sovleplenib in 2022:
Tazemetostat (TAZVERIK® in the U.S. and Japan), an inhibitor of EZH2 licensed from Epizyme for which HUTCHMED is collaborating to research, develop, manufacture and commercialize in Greater China
Potential upcoming clinical and regulatory milestones for tazemetostat in 2022:
HMPL-453, an investigative and highly selective oral inhibitor of FGFR 1/2/3
HMPL-306, an investigative and highly selective oral inhibitor of IDH1/2 designed to address resistance to the currently marketed IDH inhibitors
Major clinical and regulatory milestones for HMPL-306 in 2021:
Potential upcoming clinical and regulatory milestones for HMPL-306 in 2022:
HMPL-295, an investigative and highly selective oral inhibitor of ERK in the MAPK pathway [43] with the potential to address intrinsic or acquired resistance from upstream mechanisms such as RAS-RAF-MEK
HMPL-760, an investigative, highly selective, third-generation oral inhibitor of BTK with improved potency versus first generation BTK inhibitors against both wild type & C481S mutant enzymes
HMPL-653, an investigative, highly selective, and potent CSF-1R inhibitor designed to target CSF-1R driven tumors as a monotherapy or in combinations
HMPL-A83, a differentiated, red blood cell sparing CD47 monoclonal antibody
Other Ventures include our profitable prescription drug marketing and distribution platforms covering about 290 cities and towns in China with around 2,900 mainly manufacturing and commercial personnel.
Potential upcoming corporate developments:
COVID-19 did not impact our research, our clinical studies or our commercial activities in any material manner in 2021. Certain regulatory inspections of our manufacturing facilities in China by the U.S. FDA have, however, been postponed due to travel restrictions. We will continue to closely work with regulators and monitor the evolving situation.
VIII. SUSTAINABILITY
As an innovative, commercial-stage biopharmaceutical company, HUTCHMED embraces sustainability at the core of how we operate. Over the past two decades, we worked hard to strengthen healthcare systems by providing quality and accessible drugs. As the world is gradually adapting to the changes brought about by COVID-19, the pandemic has highlighted the importance of building sustainability and environmental, social and governance factors into business strategy. HUTCHMED has embarked on our sustainability journey in 2020 by publishing our inaugural ESG report to demonstrate our efforts, and establishing a board level Sustainability Committee in 2021 to support the Board of Directors in fulfilling their responsibilities. We plan to publish our second sustainability report for 2021 at the end of May 2022.
Going forward, HUTCHMED will be working with our stakeholders to embrace sustainable business practices and develop a sustainability strategy that will help focus our efforts on areas which are most relevant to our business. Through a materiality assessment exercise for 2021, priority areas include: Business ethics; Drug research-related topics; Drug development; Commercial operations responsibilities; Environmental topics; and Management of our people. Over the course of 2022, we will continue to engage our stakeholders to identify areas for improvement to building a more sustainable and responsible future.
Cash, Cash Equivalents and Short-Term Investments were $1,011.7 million as of December 31, 2021 compared to $435.2 million as of December 31, 2020.
Revenues for the year ended December 31, 2021 were $356.1 million compared to $228.0 million in 2020.
ELUNATE® revenues increased 168% to $53.5 million (2020: $20.0m) in manufacturing revenues, promotion and marketing service revenues and royalties, as our in-house sales team increased in-market sales 111% to $71.0 million (2020: $33.7m), as provided by Lilly[51];
SULANDA® sales revenues of $11.6 million since mid-January 2021 launch, initially approved to treat patients with advanced extra-pancreatic (non-pancreatic) NET and subsequently also approved to treat patients with pancreatic NET in June 2021;
ORPATHYS® revenue of $36.3 million since mid-July 2021 launch, which was comprised of a $25.0 million first sale milestone payment and $11.3 million in manufacturing revenues and royalties. AstraZeneca reported $15.9 million in-market sales (2020: nil) of ORPATHYS® in 2021; and
Other R&D service fee revenues of $18.2 million (2020: $10.2m), which were primarily fees from AstraZeneca and Lilly for the management of development activities in China.
Net Expenses for the year ended December 31, 2021 were $550.7 million compared to $353.7 million in 2020.
Net Loss attributable to HUTCHMED for the year ended December 31, 2021 was $194.6 million compared to $125.7 million in 2020.
Condensed Consolidated Balance Sheet Data
(in $’000)
|
As of December 31, |
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| 2021 | 2020 | |||
| Assets | ||||
| Cash and cash equivalents and short-term investments | 1,011,700 | 435,176 | ||
| Accounts receivable | 83,580 | 47,870 | ||
| Other current assets | 116,796 | 47,694 | ||
| Property, plant and equipment | 41,275 | 24,170 | ||
| Investments in equity investees | 76,479 | 139,505 | ||
| Other non-current assets | 42,831 | 29,703 | ||
| Total assets | 1,372,661 | 724,118 | ||
| Liabilities and shareholders’ equity | ||||
| Accounts payable | 41,177 | 31,612 | ||
| Other payables, accruals and advance receipts | 210,839 | 121,283 | ||
| Bank borrowings | 26,905 | 26,861 | ||
| Other liabilities | 54,226 | 25,413 | ||
| Total liabilities | 333,147 | 205,169 | ||
| Company’s shareholders’ equity | 986,893 | 484,116 | ||
| Non-controlling interests | 52,621 | 34,833 | ||
| Total liabilities and shareholders’ equity | 1,372,661 | 724,118 | ||
Condensed Consolidated Statement of Operations Data
(in $’000, except share and per share data)
| Year Ended December 31, | ||||
| 2021 | 2020 | |||
| Revenues: | ||||
| Oncology/Immunology – Marketed Products | 76,429 | 19,953 | ||
| Oncology/Immunology – R&D | 43,181 | 10,262 | ||
| Oncology/Immunology consolidated revenues | 119,610 | 30,215 | ||
| Other Ventures | 236,518 | 197,761 | ||
| Total revenues | 356,128 | 227,976 | ||
| Expenses: | ||||
| Costs of revenues | (258,234) | (188,519) | ||
| Research and development expenses | (299,086) | (174,776) | ||
| Selling and general administrative expenses | (127,125) | (61,349) | ||
| Total expenses | (684,445) | (424,644) | ||
|
Loss from Operations |
(328,317) | (196,668) | ||
| Gain on divestment of an equity investee | 121,310 | – | ||
| Other (expense)/income | (8,733) | 6,934 | ||
| Loss before income taxes and equity in earnings of equity investees | (215,740) | (189,734) | ||
| Income tax expense | (11,918) | (4,829) | ||
| Equity in earnings of equity investees, net of tax | 60,617 | 79,046 | ||
| Net loss | (167,041) | (115,517) | ||
| Less: Net income attributable to non-controlling interests | (27,607) | (10,213) | ||
| Net loss attributable to HUTCHMED | (194,648) | (125,730) | ||
|
Losses per share attributable to HUTCHMED – basic and diluted (US$ per share) |
(0.25) | (0.18) | ||
| Number of shares used in per share calculation – basic and diluted | 792,684,524 | 697,931,437 | ||
|
Losses per ADS attributable to HUTCHMED – basic and diluted (US$ per ADS) |
(1.23) | (0.90) | ||
| Number of ADSs used in per share calculation – basic and diluted | 158,536,905 | 139,586,287 | ||
All amounts are expressed in U.S. dollars unless otherwise stated.
We provide financial guidance for 2022 below reflecting expected revenue growth of ELUNATE®, SULANDA® and ORPATHYS® in China. We intend to update guidance to include ex-China consolidated revenues, upon the occurrence of surufatinib U.S. and EU approval (if granted) and to reflect any developments in the non-core market out-licensing of our products.
While we are not providing net cash flow guidance for 2022, we do expect an increase in investment to support global clinical and organizational expansion. To support our cash needs, we continue to engage in active discussions regarding the potential divestment of non-core assets, such as SHPL, as well as evaluate equity capital markets action, such as a potential future listing on the STAR Market of the Shanghai Stock Exchange.
| 2021 Actual |
2022 Guidance |
||
| Oncology/Immunology consolidated revenues | $119.6 million | $160 – 190 million | |
Shareholders and investors should note that:
Use of Non-GAAP Financial Measures and Reconciliation – References in this announcement to 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.
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Conference Call and Audio Webcast Presentation scheduled today at 9 p.m. HKT / 1 p.m. GMT / 8 a.m. EST – Investors may participate in the call as follows: +852 3027 6500 (Hong Kong) / +44 20 3194 0569 (U.K.) / +1 646 722 4977 (U.S.), or access a live audio webcast of the call via HUTCHMED’s website at www.hutch-med.com/event/.
Additional dial-in numbers are also available at HUTCHMED’s website. Please use participant access code “19304872#.”
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HUTCHMED will today file with the U.S. Securities and Exchange Commission its Annual Report on Form 20-F.
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has more than 4,600 personnel across all its companies, at the center of which is a team of over 1,500 in oncology/immunology. Since inception it has advanced 12 cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved and marketed in China. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn.
Investor Enquiries |
|
| Mark Lee, Senior Vice President | +852 2121 8200 |
| Annie Cheng, Vice President | +1 (973) 567 3786 |
Media Enquiries |
|
| Americas – Brad Miles, Solebury Trout | +1 (917) 570 7340 (Mobile) bmiles@troutgroup.com |
| Europe – Ben Atwell / Alex Shaw, FTI Consulting | +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) HUTCHMED@fticonsulting.com |
| Asia – Zhou Yi, Brunswick | +852 9783 6894 (Mobile) HUTCHMED@brunswickgroup.com |
Nominated Advisor |
|
| Atholl Tweedie / Freddy Crossley, Panmure Gordon (UK) Limited | +44 (20) 7886 2500 |
Unless the context requires otherwise, references in this announcement to the “Group,” the “Company,” “HUTCHMED,” “HUTCHMED Group,” “we,” “us,” and “our,” mean HUTCHMED (China) 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, including, among others, the risk that HUTCHMED’s ADSs could be barred from trading in the United States as a result of the Holding Foreign Companies Accountable Act and the rules promulgated thereunder; 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, uncertainties regarding future global exchange rates and uncertainties regarding the impact of the COVID-19 pandemic. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, on AIM and on HKEX. HUTCHMED 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 HUTCHMED obtained from industry publications and reports generated by third-party market research firms. Although HUTCHMED believes that the publications, reports and surveys are reliable, HUTCHMED 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 (as it forms part of retained EU law as defined in the European Union (Withdrawal) Act 2018).
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[1] AstraZeneca = AstraZeneca PLC and its wholly owned subsidiary, AstraZeneca AB (publ).
[2] NSCLC = Non-small cell lung cancer.
[3] NDA = New Drug Application.
[4] MAA = Marketing Authorisation Application.
[5] CRC = Colorectal cancer.
[6] FGFR = Fibroblast growth factor receptor.
[7] IDH = Isocitrate dehydrogenase.
[8] ERK = Extracellular signal-regulated kinase.
[9] BTK = Bruton’s tyrosine kinase.
[10] CSF-1R = Colony stimulating factor-1 receptor.
[11] In-market sales = total sales to third parties provided by Eli Lilly (ELUNATE®), AstraZeneca (ORPATHYS®) and HUTCHMED (SULANDA®).
[12] MET = Mesenchymal epithelial transition receptor.
[13] NRDL = National Reimbursement Drug List.
[14] R&D = Research and development.
[15] NMPA = National Medical Products Administration.
[16] ITP = Immune thrombocytopenia purpura.
[17] FDA = Food and Drug Administration.
[18] PDUFA = Prescription Drug User Fee Act.
[19] EMA = European Medicines Agency.
[20] EOP2 = End of Phase 2.
[21] EGFR = Epidermal growth factor receptor.
[22] TKI = Tyrosine kinase inhibitor.
[23] ASCO = American Society of Clinical Oncology.
[24] WCLC = World Conference on Lung Cancer.
[25] VEGFR = Vascular endothelial growth factor receptor.
[26] NEC = Neuroendocrine carcinoma.
[27] Junshi = Shanghai Junshi Biosciences Co., Ltd.
[28] PMDA = Japanese Pharmaceuticals and Medical Devices Agency.
[29] BeiGene = BeiGene, Ltd.
[30] PD-1 = Programmed Cell Death Protein-1.
[31] ESMO IO = European Society for Medical Oncology Immuno-Oncology Congress.
[32] CgA = Chromogranin A.
[33] BTC = Biliary tract cancer.
[34] HCC = Hepatocellular carcinoma.
[35] RCC = Renal cell cancer.
[36] CSCO = Chinese Society of Clinical Oncology Annual Meeting.
[37] Genor = Genor Biopharma Co. Ltd.
[38] OS = Overall survival.
[39] PI3Kδ = Phosphoinositide 3-kinase delta.
[40] RP2D = Recommended Phase II dose.
[41] Syk = Spleen tyrosine kinase.
[42] ASH 2021 = the 63rd ASH Annual Meeting and Exposition in December 2021.
[43] MAPK pathway = RAS-RAF-MEK-ERK signaling cascade.
[44] We also report changes in performance at constant exchange rate (“CER”) which is a non-GAAP measure. 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.
[45] SHPL = Shanghai Hutchison Pharmaceuticals Limited.
[46] HBYS = Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited.
[47] HKEX = The Stock Exchange of Hong Kong Limited.
[48] Inmagene = Inmagene Biopharmaceuticals.
[49] Hutchison Sinopharm = Hutchison Whampoa Sinopharm Pharmaceuticals (Shanghai) Company Limited.
[50] GAAP = Generally Accepted Accounting Principles.
[51] Lilly = Eli Lilly and Company.
[52] SG&A Expenses = selling, general and administrative expenses.
[53] ADS = American depositary share.