Full Press Release Details
HUTCHMED (China) Limited Supplemental and Updated Disclosures
We recently filed an application (the "Listing Application") with The Stock Exchange of Hong Kong Limited (the "Stock Exchange") in connection with a proposed listing (the "Listing") of our ordinary shares, par value US$0.10 per share ("Shares"), on the Main Board of the Stock Exchange.
The Listing Application contains supplemental and additional descriptions of certain aspects of our business and financial information as required by the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited as well as updated disclosure of certain information previously disclosed in our annual report on Form 20-F for the year ended December 31, 2020 filed on March 4, 2021 (the "2020 Annual Report"). This exhibit sets forth such new, supplemental and updated information and disclosures as described below. The disclosure herein supplements and should be read in conjunction with the disclosure in our 2020 Annual Report and other disclosures furnished on Form 6-K.
There is no assurance as to if or when such Listing will take place. This communication is neither an offer to sell nor a solicitation of an offer to buy, nor shall there be any offer, solicitation or sale of our securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.
FORWARD LOOKING STATEMENTS
This Exhibit contains forward-looking statements that involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. The words "anticipate," "assume," "believe," "contemplate," "continue," "could," "estimate," "expect," "goal," "intend," "may," "might," "objective," "plan," "potential," "predict," "project," "positioned," "seek," "should," "target," "will," "would," or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on current expectations, estimates, forecasts and projections about our business and the industry in which we operate and management's beliefs and assumptions, are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors.
Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. As a result, any or all of our forward-looking statements in this Exhibit may turn out to be inaccurate. We have included important factors in the cautionary statements included in this Exhibit and in the 2020 Annual Report, particularly in the section of the 2020 Annual Report titled "Risk Factors", that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Moreover, we operate in a highly competitive and rapidly changing environment in which new risks often emerge. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make.
The forward-looking statements contained herein are made as of the date of the filing of this Exhibit, and we do not assume any obligation to update any forward-looking statements except as required by applicable law. We undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this Exhibit completely in conjunction with our annual reports on Form 20-F and other documents filed with or furnished to the SEC and with the understanding that our actual future results may be materially different from what we expect.
| Recent Developments | 4 | |||||||
| Information About the Listing | 11 | |||||||
| Risk Factors | 13 | |||||||
| Industry Overview | 20 | |||||||
| Business | 77 | |||||||
| Financial Information | 160 |
| The following sets forth updated information subsequent to the filing of our 2020 Annual Report. | ||||
| For our unaudited consolidated financial statements as of March 31, 2021 and for the three months ended March 31, 2020 and 2021, please refer to Exhibit 99.1, titled "Unaudited First Quarter 2021 Financial Information", of our report on Form 6-K furnished to the SEC on June 21, 2021 and the related disclosures contained herein and therein. |
SUMMARY OF FIRST QUARTER 2021 HIGHLIGHTS
Cash and cash equivalents and short-term investments were US$396.1 million as of March 31, 2021 compared to US$435.2 million as of December 31, 2020.
Revenues increased by 58.1% to US$81.6 million for the three months ended March 31, 2021 from US$51.6 million for the three months ended March 31, 2020.
Oncology/Immunology revenues increased by 227.3% to US$21.7 million for the three months ended March 31, 2021 from US$6.6 million for the three months ended March 31, 2020.
Accelerating Sales Growth of Elunate - Sales of Elunate generated revenues of US$13.4 million for the three months ended March 31, 2021 compared to US$2.9 million for the three months ended March 31, 2020. In-market sales of Elunate were US$20.2 million for the three months ended March 31, 2021 compared to US$7.3 million for the three months ended March 31, 2020, as provided by Eli Lilly.
Launch of Sulanda - We commercially launched Sulanda as a treatment for patients with advanced non-pancreatic NET in China in mid-January 2021 within three weeks of approval from China's National Medical Products Administration (the "NMPA"). We had revenues of US$5.5 million from sales of Sulanda for the three months ended March 31, 2021.
Other Ventures revenues increased by 33.2% to US$59.9 million for the three months ended March 31, 2021 from US$45.0 million for the three months ended March 31, 2020.
Research and development expenses incurred by Oncology/Immunology increased by 87.0% to US$57.1 million for the three months ended March 31, 2021 from US$30.5 million for the three months ended March 31, 2020, primarily due to a significant expansion of clinical activities in the United States and rapid organizational growth to support such expansion. In particular, this increase was attributable to the expansion of the fruquintinib, surufatinib, HMPL-689 and HMPL-306 development programs. Our international clinical and regulatory operations in the United States and Europe incurred research and development expenses of US$30.6 million for the three months ended March 31, 2021 compared to US$8.0 million for the three months ended March 31, 2020. We expect to incur significant expenses, particularly research and development expenses, for the foreseeable future as we expand our development of, and seek regulatory approvals for, our drug candidates.
Net loss attributable to our Company was US$41.1 million for the three months ended March 31, 2021 compared to US$16.1 million for the three months ended March 31, 2020. Net loss attributable to our Company was US$0.06 per ordinary share for the three months ended March 31, 2021 compared to US$0.02 per ordinary share for the three months ended March 31, 2020.
On March 24, 2021, we entered into a sale and purchase agreement with GL Mountrose Investment Two Limited, a company controlled and managed by GL Capital Group, to sell our entire investment in
Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited, our non-consolidated joint venture ("Hutchison Baiyunshan"). GL Capital Group is an investment firm that focuses on buyout and growth opportunities in China's healthcare industry and is an independent third party which has a minority interest in the Company and is not a connected person of the Company. The disposal is subject to regulatory approval in China and is expected to be completed in the second half of 2021.
The aggregate amounts to be received attributable to the Company are approximately US$169 million, of which approximately US$127 million is related to our shareholding in Hutchison Baiyunshan and approximately US$42 million is related to distributions of the land compensation and the prior year's undistributed profits. A deposit of approximately US$15.9 million paid upon signing of the agreement will be credited against the proceeds due on completion of the disposal.
Following the completion of the disposal, the Group will cease equity accounting of the financial results of Hutchison Baiyunshan, and will derecognize the carrying value of the Company's investment in Hutchison Baiyunshan and recognize a disposal gain attributable to the Company estimated at approximately US$80-90 million, net of taxes. The Group will exit from the over-the-counter drug arena upon the disposal. As our focus is the discovery and development of novel therapies in oncology and immunology, the sale of our interest in Hutchison Baiyunshan will allow us to focus resources on our primary aim of accelerating investment in our Oncology/Immunology assets.
Baring Private Placement
On April 14, 2021, the Company completed the sale of US$100 million of Shares at a price of US$6.10 per Share (equivalent to an ADR price of US$30.50 per ADS) via a private placement to Pachytene Limited, an investment holding company wholly owned by Baring Asia Private Equity Fund VII.
Our unaudited condensed consolidated statements of operations and cash flows presented below for the three months ended March 31, 2020 and 2021 and our unaudited condensed consolidated balance sheet as of March 31, 2021 have been derived from our unaudited consolidated financial statements as of March 31, 2021 and for the three months ended March 31, 2020 and 2021, included as Exhibit 99.1 of our report on Form 6-K furnished to the SEC on June 21, 2021 ("Unaudited First Quarter 2021 Financial Information"). The unaudited interim financial information for the three months ended March 31, 2021 has been prepared on the same basis as our audited consolidated financial data and has been reviewed by our reporting accountant in accordance with Hong Kong Standard on Review Engagements 2410. Please refer to our Unaudited First Quarter 2021 Financial Information for a discussion of the effect of material differences between the financial information of the Company prepared under U.S. GAAP and IFRS.
The consolidated financial information below should be read in conjunction with, and is qualified in its entirety by reference to, our audited consolidated financial statements for the years ended December 31, 2018, 2019 and 2020 and as of December 31, 2018, 2019 and 2020 and related notes contained in our 2020 Annual Report. Our historical results do not necessarily indicate results expected for any future periods, and the results of operations for the three months ended March 31, 2021 are not necessarily indicative of the results to be expected for the full fiscal year ending December 31, 2021.
Condensed Consolidated Statements of Operations
| Three Months Ended March 31, | |||||||||||||
| 2020 | 2021 | ||||||||||||
| US$'000 (Unaudited) | |||||||||||||
| Revenues | |||||||||||||
| Goods - third parties | 45,971 | 67,060 | |||||||||||
| - related parties | 767 | 1,306 | |||||||||||
| Services | |||||||||||||
| - commercialization - third parties | - | 7,406 | |||||||||||
| - collaboration research and development - third parties | 3,618 | 2,706 | |||||||||||
| - research and development - related parties | 121 | 130 | |||||||||||
| Other collaboration revenue - royalties - third parties | 1,093 | 2,948 | |||||||||||
| Total revenues | 51,570 | 81,556 | |||||||||||
| Operating expenses | |||||||||||||
| Costs of goods - third parties | (40,778 ) | (54,872 ) | |||||||||||
| Costs of goods - related parties | (512 ) | (954 ) | |||||||||||
| Costs of services - commercialization - third parties | - | (9,114 ) | |||||||||||
| Research and development expenses | (30,511 ) | (57,059 ) | |||||||||||
| Selling expenses | (2,594 ) | (5,733 ) | |||||||||||
| Administrative expenses | (9,667 ) | (17,024 ) | |||||||||||
| Total operating expenses | (84,062 ) | (144,756 ) | |||||||||||
| (32,492 ) | (63,200 ) | ||||||||||||
| Other income, net of other expenses | 1,172 | 293 | |||||||||||
| Loss before income taxes and equity in earnings of equity investees | (31,320 ) | (62,907 ) | |||||||||||
| Income tax expense | (1,045 ) | (1,939 ) | |||||||||||
| Equity in earnings of equity investees, net of tax | 16,939 | 24,993 | |||||||||||
| Net loss | (15,426 ) | (39,853 ) | |||||||||||
| Less: Net income attributable to non-controlling interests | (715 ) | (1,290 ) | |||||||||||
| Net loss attributable to our Company | (16,141 ) | (41,143 ) | |||||||||||
| Losses per share attributable to our Company - basic and diluted (US$ per share) | (0.02 ) | (0.06 ) | |||||||||||
| Number of shares used in per share calculation - basic and diluted | 683,855,237 | 723,176,387 |
Condensed Consolidated Balance Sheets
| December 31, 2020 | March 31, 2021 | ||||||||||||
| US$'000 | |||||||||||||
| (Unaudited) | |||||||||||||
| Assets | |||||||||||||
| Current assets | |||||||||||||
| Cash and cash equivalents | 235,630 | 346,133 | |||||||||||
| Short-term investments | 199,546 | 49,939 | |||||||||||
| Accounts receivable - third parties | 46,648 | 53,128 | |||||||||||
| Inventories | 19,766 | 19,757 | |||||||||||
| Other current assets | 29,150 | 27,273 | |||||||||||
| Total current assets | 530,740 | 496,230 | |||||||||||
| Property, plant and equipment | 24,170 | 26,257 | |||||||||||
| Right-of-use assets | 8,016 | 9,849 | |||||||||||
| Investments in equity investees | 139,505 | 133,816 | |||||||||||
| Other non-current assets | 21,687 | 26,965 | |||||||||||
| Total assets | 724,118 | 693,117 | |||||||||||
| Liabilities and shareholders' equity | |||||||||||||
| Current liabilities | |||||||||||||
| Accounts payable | 31,612 | 28,636 | |||||||||||
| Other payables, accruals and advance receipts | 120,882 | 150,332 | |||||||||||
| Lease liabilities | 2,785 | 3,970 | |||||||||||
| Other current liabilities | 3,118 | 5,577 | |||||||||||
| Total current liabilities | 158,397 | 188,515 | |||||||||||
| Lease liabilities | 6,064 | 6,529 | |||||||||||
| Long-term bank borrowings | 26,861 | 26,872 | |||||||||||
| Other non-current liabilities | 13,847 | 6,806 | |||||||||||
| Total liabilities | 205,169 | 228,722 | |||||||||||
| Commitments and contingencies | |||||||||||||
| Company's shareholders' equity | |||||||||||||
| Ordinary shares | 72,772 | 72,812 | |||||||||||
| Additional paid-in capital | 822,458 | 808,776 | |||||||||||
| Accumulated losses | (415,591 ) | (456,742 ) | |||||||||||
| Accumulated other comprehensive income | 4,477 | 3,425 | |||||||||||
| Total Company's shareholders' equity | 484,116 | 428,271 | |||||||||||
| Non-controlling interests | 34,833 | 36,124 | |||||||||||
| Total shareholders' equity | 518,949 | 464,395 | |||||||||||
| Total liabilities and shareholders' equity | 724,118 | 693,117 |
Condensed Consolidated Statements of Cash Flows
| Three Months Ended March 31, | |||||||||||||
| 2020 | 2021 | ||||||||||||
| US$'000 (Unaudited) | |||||||||||||
| Net cash used in operating activities | (1,757 ) | (22,356 ) | |||||||||||
| Investing activities | |||||||||||||
| Purchases of property, plant and equipment | (2,087 ) | (6,057 ) | |||||||||||
| Deposits in short-term investments | (191,764 ) | (49,943 ) | |||||||||||
| Proceeds from short-term investments | 96,011 | 199,549 | |||||||||||
| Deposit received for divestment of Hutchison Baiyunshan | - | 15,912 | |||||||||||
| Purchase of leasehold land | - | (355 ) | |||||||||||
| Refund of leasehold land deposit | - | 930 | |||||||||||
| Net cash (used in)/generated from investing activities | (97,840 ) | 160,036 | |||||||||||
| Financing activities | |||||||||||||
| Proceeds from issuance of ordinary shares | 118,341 | 242 | |||||||||||
| Purchases of treasury shares | - | (26,758 ) | |||||||||||
| Payment of issuance costs | (7,643 ) | (231 ) | |||||||||||
| Net cash generated from/(used in) financing activities | 110,698 | (26,747 ) | |||||||||||
| Net increase in cash and cash equivalents | 11,101 | 110,933 | |||||||||||
| Effect of exchange rate changes on cash and cash equivalents | (18 ) | (430 ) | |||||||||||
| 11,083 | 110,503 | ||||||||||||
| Cash and cash equivalents | |||||||||||||
| Cash and cash equivalents at beginning of period | 121,157 | 235,630 | |||||||||||
| Cash and cash equivalents at end of period | 132,240 | 346,133 |
Three Months Ended March 31, 2020 Compared to Three Months Ended March 31, 2021
Set forth below is a discussion of our unaudited consolidated statements of operations for the three months ended March 31, 2020 and 2021:
Revenues. Our revenue increased by 58.1% from US$51.6 million for the three months ended March 31, 2020 to US$81.6 million for the three months ended March 31, 2021, which was caused by increased revenue from both Oncology/Immunology and Other Ventures operations.
Revenue from Oncology/Immunology increased by 227.3% from US$6.6 million for the three months ended March 31, 2020 to US$21.7 million for the three months ended March 31, 2021, primarily due to the commercial launch of Sulanda in January 2021 which generated revenue of US$5.5 million for the three months ended March 31, 2021. Furthermore, there was an increase in revenue related to the sale of Elunate from US$2.9 million for the three months ended March 31, 2020 to US$13.4 million for the three months ended March 31, 2021 which was mainly comprised US$7.4 million in service revenue from promotion and marketing services to Eli Lilly and an increase in manufacturing sales and royalties of US$3.1 million across these periods.
Revenue from our Other Ventures increased by 33.2% from US$45.0 million for the three months ended March 31, 2020 to US$59.9 million for the three months ended March 31, 2021, primarily due to an increase in sales of prescription drug products which increased by 28.7% from US$38.0 million for the three months ended March 31, 2020 to US$49.0 million for the three months ended March 31, 2021 resulting from increased sales by our consolidated joint venture Hutchison Sinopharm. Revenues from our consumer health products also increased by 58.0% from US$7.0 million for the three months ended
March 31, 2020 to US$10.9 million for the three months ended March 31, 2021, primarily due to an increase in sales of infant nutrition products.
Cost of Revenues. Our cost of revenues increased by 57.3% from US$41.3 million for the three months ended March 31, 2020 to US$64.9 million for the three months ended March 31, 2021. This increase was primarily due to increased sales by our Other Ventures as well as the cost of promotion and marketing services to Eli Lilly which commenced in October 2020. Cost of revenues as a percentage of revenue was relatively stable at 80.1% for the three months ended March 31, 2020 and 79.6% for the three months ended March 31, 2021.
Research and Development Expenses. Our research and development expenses incurred by Oncology/Immunology increased by 87.0% from US$30.5 million for the three months ended March 31, 2020 to US$57.1 million for the three months ended March 31, 2021, which was primarily attributable to a US$17.2 million increase in CRO and other clinical trial related costs and a US$6.0 million increase in employee compensation related costs. These increased costs were due to a significant expansion of clinical activities in the United States and rapid organizational growth to support such expansion. In particular, this increase was attributable to the expansion of the fruquintinib, surufatinib, HMPL-689 and HMPL-306 development programs. As a result, research and development expenses as a percentage of our revenue increased from 59.2% to 70.0% across these periods.
Selling Expenses. Our selling expenses increased by 121.0% from US$2.6 million for the three months ended March 31, 2020 to US$5.7 million for the three months ended March 31, 2021, primarily due to promotion and marketing expenses incurred for the sale of Sulanda in China which launched in January 2021. As a result, selling expenses as a percentage of our revenues increased from 5.0% to 7.0% across these periods.
Administrative Expenses. Our administrative expenses increased by 76.1% from US$9.7 million for the three months ended March 31, 2020 to US$17.0 million for the three months ended March 31, 2021. This was primarily due to US$3.8 million increase in administrative expenses incurred by Oncology/ Immunology, which was mainly related to increased staff cost to support the expansion of our clinical activities. There was also an increase of US$2.9 million in administrative expenses incurred by our corporate head office for organizational expansion. Administrative expenses as a percentage of our revenues increased from 18.7% to 20.9% across these periods.
Other Income, net. We had net other income of US$1.2 million for the three months ended March 31, 2020, compared to net other income of US$0.3 million for the three months ended March 31, 2021. The decrease was primarily due to a decline in interest income of US$0.5 million mainly due to lower bank deposit rates and an increase of exchange loss of US$0.6 million. Such decrease was partly offset by a decrease in interest expenses of US$0.2 million due to lower bank borrowing rates.
Income Tax Expense. Our income tax expense increased from US$1.0 million for the three months ended March 31, 2020 to US$1.9 million for the three months ended March 31, 2021, primarily due to higher withholding taxes accrued as a result of an increase in net income of Shanghai Hutchison Pharmaceuticals and higher taxable income in relation to commercial activities.
Equity in Earnings of Equity Investees. Our equity in earnings of equity investees, net of tax, increased by 47.5% from US$16.9 million for the three months ended March 31, 2020 to US$25.0 million for the three months ended March 31, 2021. This change was primarily due to an increase in net income of Shanghai Hutchison Pharmaceuticals.
Net Loss. As a result of the foregoing, our net loss increased from US$15.4 million for the three months ended March 31, 2020 to US$39.9 million for the three months ended March 31, 2021. Net loss attributable to our Company increased from US$16.1 million for the three months ended March 31, 2020 to US$41.1 million for the three months ended March 31, 2021. The increase in net losses is primarily due to an increase in research and development expenses, as a result of a significant expansion of clinical activities.
Cash Flows and Capital Commitments
Set forth below is a discussion of our unaudited consolidated cash flows for the three months ended March 31, 2020 and 2021:
Net Cash used in Operating Activities. Net cash used in operating activities was US$1.8 million for the three months ended March 31, 2020, compared to net cash used in operating activities of US$22.4 million for the three months ended March 31, 2021. The net change of US$20.6 million was primarily attributable to an increase in research and development expenses of US$26.6 million from US$30.5 million for three months ended March 31, 2020 to US$57.1 million for the three months ended March 31, 2021.
Net Cash (used in)/generated from Investing Activities. Net cash used in investing activities was US$97.8 million for the three months ended March 31, 2020, compared to net cash generated from investing activities of US$160.0 million for the three months ended March 31, 2021. The net change of US$257.8 million was primarily attributable to net deposits in short-term investments of US$95.8 million for the three months ended March 31, 2020 compared to the net withdrawal of deposits in short-term investments of US$149.6 million for the three months ended March 31, 2021. The net change was also due to our receipt of a US$15.9 million deposit in March 2021 in connection with our planned divestment of Hutchison Baiyunshan.
Net Cash generated from/(used in) Financing Activities. Net cash generated from financing activities was US$110.7 million for the three months ended March 31, 2020, compared to net cash used in financing activities of US$26.7 million for the three months ended March 31, 2021. The net change of US$137.4 million was primarily attributable to net proceeds of US$110.7 million from our follow-on offering in the United States in January and February 2020. This net change was also due to the purchases of treasury shares of US$26.8 million for the three months ended March 31, 2021.
Capital Expenditures. We had capital expenditures of US$2.1 million and US$6.1 million for the three months ended March 31, 2020 and 2021, respectively. Our capital expenditures for the three months ended March 31, 2021 were primarily used for the construction of our new manufacturing facility in Shanghai. Our capital expenditures have been primarily funded by cash flows from operations and proceeds from our initial public and follow-on offerings in the United States and other equity offerings.
As of March 31, 2021, we had commitments for capital expenditures of approximately US$44.2 million, primarily for the construction of our new manufacturing facility in Shanghai. We expect to fund these capital expenditures through cash flows from operations, bank borrowings and existing cash resources.
INFORMATION ABOUT THE LISTING
Register of Members and Stamp Duty
Our principal register of members will be maintained by our principal share registrar in the Cayman Islands, and our Hong Kong register of members will be maintained by the Hong Kong Share Registrar, Computershare Hong Kong Investor Services Limited, in Hong Kong.
Dealings in our Shares which are registered on our Hong Kong share register will be subject to Hong Kong stamp duty. The stamp duty is charged to each of the seller and purchaser at the ad valorem rate of 0.1% (which is proposed to be increased to 0.13% as announced by the Hong Kong Government in its Budget for 2021/22 and to be effective upon approval by the Legislative Council and the enactment of amendments to the Stamp Duty Ordinance) of the consideration or, if higher, the fair value of the Shares transferred. In other words, a total of 0.2% (which is proposed to be increased to 0.26% as announced by the Hong Kong Government in its Budget for 2021/22 and to be effective upon approval by the Legislative Council and the enactment of amendments to the Stamp Duty Ordinance) is currently payable on a typical sale and purchase transaction of our Shares. In addition, a fixed duty of HK$5.00 is charged on each instrument of transfer (if required).
Dealings and Settlement of Shares in Hong Kong
Our Shares will trade on the Stock Exchange in board lots of 500 Shares. Dealings in our Shares on the Stock Exchange will be conducted in Hong Kong dollars.
The transaction costs of dealings in our Shares on the Stock Exchange include:
The Stock Exchange trading fee of 0.005% of the consideration of the transaction, charged to each of the buyer and seller;
Securities and Futures Commission of Hong Kong transaction levy of 0.0027% of the consideration of the transaction, charged to each of the buyer and seller;
trading tariff of HK$0.50 on each and every purchase or sale transaction. The decision on whether or not to pass the trading tariff onto investors is at the discretion of brokers;
transfer deed stamp duty of HK$5.00 per transfer deed (if applicable), payable by the seller;
ad valorem stamp duty at a total rate of 0.2% of the value of the transaction, with 0.1% payable by each of the buyer and the seller (which is proposed to be increased to 0.13% payable by each of the buyer and the seller);
stock settlement fee, which is currently 0.002% of the gross transaction value, subject to a minimum fee of HK$2.00 and a maximum fee of HK$100.00 per side per trade;
brokerage commission, which is freely negotiable with the broker (other than brokerage commissions for IPO transactions which are currently set at 1% of the subscription or purchase price and will be payable by the person subscribing for or purchasing the securities); and
the Hong Kong share registrar will charge between HK$2.50 to HK$20, depending on the speed of service (or such higher fee as may from time to time be permitted under the Rules Governing the Listing of Securities on The Stock Exchange ("Listing Rules"), for each transfer of Shares
from one registered owner to another, each share certificate canceled or issued by it and any applicable fee as stated in the share transfer forms used in Hong Kong.
Investors must settle their trades executed on the Hong Kong Stock Exchange through their brokers directly or through custodians. For an investor who has deposited his/her Shares in his/her stock account or in his/her designated CCASS (Central Clearing and Settlement System established and operated by Hong Kong Securities Clearing Company Limited) participant's stock account maintained with CCASS, settlement will be effected in CCASS in accordance with the General Rules of CCASS and CCASS Operational Procedures in effect from time to time. For an investor who holds the physical certificates, settlement certificates and the duly executed transfer forms must be delivered to his/her broker or custodian before the settlement date.
Exchanges Between Shares Trading in Hong Kong and ADSs
In connection with the initial public offering of our Shares in Hong Kong, or the Hong Kong Public Offering, we have established a branch register of members in Hong Kong, or the Hong Kong share register, which will be maintained by our Hong Kong Share Registrar, Computershare Hong Kong Investor Services Limited. Our principal register of members, or the Cayman share register, will continue to be maintained by our Principal Share Registrar, Computershare Investor Services (Jersey) Limited.
All Shares offered in the Hong Kong Public Offering will be registered on the Hong Kong share register in order to be listed and traded on the Hong Kong Stock Exchange. Holders of Shares registered on the Hong Kong share register will be able to exchange those Shares for ADSs and vice versa.
RISKS RELATING TO OUR FINANCIAL POSITION AND NEED FOR CAPITAL
We have incurred significant net operating cash outflows during the three financial years ended December 31, 2020, and may continue to experience net cash outflow from operating activities.
Investment in biopharmaceutical drug development is highly speculative. It entails substantial upfront expenditures and significant risk that a drug candidate might fail to gain regulatory approval or become commercially viable. We continue to incur significant expenses related to our ongoing operations. Net cash used in operating activities was US$32.8 million, US$80.9 million and US$62.1 million for the years ended December 31, 2018, 2019 and 2020, respectively. We expect to incur significant expenses, particularly research and development expenses, for the foreseeable future as we expand our development of, and seek regulatory approvals for, our drug candidates. Typically, it takes many years to develop one new drug from the drug discovery stage to the time it is available for treating patients. Our ability to improve our cash flow depends on a number of variables, including the number and scope of our drug development programs and the associated costs of those programs, the cost of commercializing any approved products, our ability to generate revenues and the timing and amount of milestones and other payments we make or receive through arrangements with third parties. Our failure to generate positive cash flow from operations may adversely affect our ability to raise capital, maintain our research and development efforts, expand our business or continue our operations. There is no assurance that we will be able to generate sufficient net cash inflows from operating activities, which could have adverse effects on our long-term viability.
We face risks with our short-term investments and in collecting our accounts receivables.
Our short-term investments are bank deposits with maturities of more than three months but less than one year. Our short-term investments were US$214.9 million, US$96.0 million and US$199.5 million as of December 31, 2018, 2019 and 2020, respectively, and are placed with major financial institutions. These investments may earn yields substantially lower than expected. Failure to realize the benefits we expected from these investments may materially and adversely affect our business and financial results. To date, we have experienced no loss or lack of access to our invested cash or cash equivalents; however, we can provide no assurance that access to our invested cash and cash equivalents will not be impacted by adverse conditions in the financial and credit markets.
Our accounts receivable - third parties balance, net of allowance for credit losses, totaled US$40.2 million, US$41.4 million and US$46.6 million as of December 31, 2018, 2019 and 2020, respectively. We have policies and procedures in place to ensure that sales are made to customers with an appropriate credit history. We perform periodic credit evaluations of our customers and monitor risk factors and forward-looking information, such as country risk, when determining credit limits for customers. However, there can be no assurance such policies and procedures will effectively limit our credit risk and enable us to avoid losses, which could adversely affect our financial condition and results of operations. In addition, amounts due to us are not covered by collateral or credit insurance. As of April 30, 2021, US$41.4 million, or 89%, of the total accounts receivable - third parties outstanding as of December 31, 2020 had been settled. If we fail to collect all or part of such accounts receivable in a timely manner, or at all, our financial condition may be materially and adversely affected.
RISKS RELATING TO OUR ONCOLOGY/IMMUNOLOGY OPERATIONS AND DEVELOPMENT OF OUR DRUG CANDIDATES
If we participate in compassionate-use programs, discrepancies among the regulations in different countries may lead to increased risk of adverse drug reactions and serious adverse events arising from the use of our drug candidates.
Compassionate-use programs are regulatory programs that facilitate access to investigational drugs for the treatment of patients with serious or immediately life-threatening diseases or conditions that lack therapeutic alternatives. Currently, there is no unified approach or standard practice to regulate compassionate-use programs or access to investigational drugs across countries. In China, the NMPA and the National Health Commission issued the Promulgation of the Administrative Provisions on Extended Clinical Trials of Medical Devices (for Trial Implementation) on March 14, 2020, with immediate effect, providing a route for patients suffering from life-threatening diseases without existing effective treatments to engage treatment that is yet to be approved for marketing. In the United States, compassionate-use programs are limited to patients who have a life-threatening disease or serious disease or condition, who may gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. Additionally, the U.S. Right to Try Act provides a separate pathway for patients with a life-threatening disease or condition who have exhausted all other treatment options and who are unable to participate in clinical trials to access investigational drugs that have passed Phase I clinical trials under a more expedited process.
The regulatory discrepancy for compassionate-use programs among countries may lead to uneven patient entry criteria and protocols for compassionate-use programs. This may create increased risk of serious adverse events because of enrolled patients' advanced disease or comorbidities. In addition, because the products in compassionate-use programs are investigational drugs, many of which are still in experimental stages and have not received marketing approval, patients in compassionate-use program may exhibit adverse drug reactions from using these products. If we participate in compassionate-use programs, we may be subject to the risk of enrolled patients exhibiting adverse drug reactions or serious adverse events being produced from the use of our future drug products. Such occurrences can potentially lead to clinical holds of our ongoing clinical trials or complicate the determination of the safety profile of a drug candidate under regulatory review for commercial marketing, or expose us to tort liability. Changes in government regulations or in practices relating to the pharmaceutical and biopharmaceutical industries, including healthcare reform in China, and compliance with new regulations may result in additional costs.
RISKS RELATING TO SALES OF OUR INTERNALLY DEVELOPED DRUGS AND OTHER DRUGS
As a significant portion of the operations of our Other Ventures is conducted through joint ventures, we are dependent on the success of our joint ventures and our receipt of dividends or other payments from our joint ventures for cash to fund our operations and our investments in our joint ventures are subject to liquidity risk.
We are party to joint venture agreements with Shanghai Traditional Chinese Medicine Co., Ltd. ("Shanghai Pharmaceuticals") and Guangzhou Baiyunshan Pharmaceutical Holdings Company Limited ("Guangzhou Baiyunshan"), relating to our non-consolidated joint ventures, which together form part of the operations of our Other Ventures. Our equity in the earnings of these non-consolidated joint ventures, net of tax, was US$38.3 million, US$40.6 million and US$79.1 million for the years ended December 31, 2018, 2019 and 2020, respectively, as recorded in our consolidated financial statements. Equity in earnings of Hutchison Baiyunshan for the year ended December 31, 2020 included a one-time gain of US$36.0 million from land compensation for a return of land use rights to the Guangzhou government. As such, our results of operations and financial performance have been, and will continue to be, affected by the financial performance of these joint ventures as well as any other equity investees we have or may have in the future. We may also be required to recognize an impairment charge in our consolidated financial statements if there is a decline in the fair market value of our investments in such
businesses below their carrying amounts for whatever reason that is determined to be other-than-temporary. Furthermore, we have consolidated joint ventures with each of Sinopharm and Hain Celestial which accounted for substantially all of our Other Ventures' consolidated revenue for the years ended December 31, 2018, 2019 and 2020.
As a result, our ability to fund our operations and pay our expenses or to make future dividend payments, if any, is largely dependent on the earnings of our joint ventures and the payment of those earnings to us in the form of dividends. Payments to us by our joint ventures will be contingent upon our joint ventures' earnings and other business considerations and may be subject to statutory or contractual restrictions. Each joint venture's ability to distribute dividends to us is subject to approval by their respective boards of directors, which in the case of Shanghai Hutchison Pharmaceuticals and Hutchison Baiyunshan are comprised of an equal number of representatives from each party. Furthermore, our ability to promptly sell one or more of our interests in our joint ventures in response to changing corporate strategy or economic, financial and investment conditions is limited. The market for such investments can be affected by various factors, such as general economic and market conditions, availability of financing, interest rates and investor demand, many of which are beyond our control. If we determine to sell any of our joint venture investments, we cannot predict if we will be successful or whether any price or other terms offered by a prospective purchaser would be acceptable to us.
Operationally, our joint venture partners have certain responsibilities and/or certain rights to exercise control or influence over operations and decision-making under the joint venture arrangements. Therefore, the success of our joint ventures depends on the efforts and abilities of our joint venture parties to varying degrees. For example, we share the ability to appoint the general manager of our joint venture with Guangzhou Baiyunshan, with each of us having a rotating four-year right, and therefore, our ability to manage the day-to-day operations of this joint venture is more limited. On the other hand, we appoint the general managers of Hutchison Sinopharm and Shanghai Hutchison Pharmaceuticals pursuant to the respective joint venture agreements governing these entities and therefore oversee the day-to-day management of these joint ventures. However, we still rely on our joint venture partners Sinopharm and Shanghai Pharmaceuticals to provide certain distribution and logistics services.
We may not be successful in building a commercial team to successfully manufacture, sell and market our approved drugs, and we may not be able to generate any revenue from such products.
We have leveraged our experience operating our prescription drugs business to commercialize certain of our approved, internally developed drug candidates in China. We must adapt our know-how to build a specific oncology and/or immunology focused sales and marketing team. As of December 31, 2020, we had an oncology commercial team with about 390 staff in China to support the commercialization of fruquintinib, surufatinib and our other drug candidates, if approved.
There are risks involved in establishing an in-house oncology commercial team. For example, recruiting and/or training a sales force to detail our approved drug candidates is time consuming and could delay any drug launch. Factors that may inhibit our efforts to commercialize our drug candidates include:
our inability to recruit and retain adequate numbers of effective sales and marketing personnel;
our inability to effectively manage the expansion of our operations and train additional qualified personnel in the relevant areas of oncology and/or immunology;
the inability of our sales personnel to obtain access to physicians or educate adequate numbers of physicians who then prescribe any future drugs; and
the lack of complementary drugs to be offered by our sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines.
In such case, our business, results of operations, financial condition and prospects will be materially and adversely affected.
We may engage in strategic transactions, including acquisitions, investments, joint ventures or divestitures that may have an adverse effect on our business. If we engage in a strategic transaction, there is no assurance that the transaction will be consummated.
We may pursue transactions as part of our business strategy, including continuing to actively evaluate non-core assets divestment opportunities. For instance, on March 24, 2021, we entered into a sale and purchase agreement with GL Mountrose Investment Two Limited, a company controlled and managed by GL Capital Group, to sell our entire investment in Hutchison Baiyunshan. See "Recent Developments" for more information.