3SBio Inc. Announces Unaudited Fourth Quarter and Full Year 2010 Results
Full Year 2010 Financial Highlights:
- Total net revenues in 2010 increased by 32.1% to
RMB418.6 million (US$63.4 million ), compared toRMB316.9 million (US$46.4 million ) in 2009. - GAAP operating income in 2010 increased by 2.8% to
RMB86.8 million (US$13.2 million ), compared toRMB84.4 million (US$12.4 million ) in 2009. Non-GAAP operating income in 2010 increased by 14.7% toRMB96.8 million (US$14.7 million ), compared toRMB84.4 million (US$12.4 million ) in 2009. - GAAP net income decreased by 2.6% to
RMB81.3 million (US$12.3 million ), compared toRMB83.4 million (US$12.2 million ) in 2009. Non-GAAP net income increased by 9.0% toRMB91.2 million (US$13.8 million ), compared toRMB83.7 million (US$12.3 million ) in 2009. - GAAP net income per American Depositary Share ("ADS") on a fully-diluted basis was
RMB3.69 (US$0.56) compared toRMB3.87 (US$0.57) in 2009. Non-GAAP net income per ADS on a fully-diluted basis in 2010 wasRMB4.14 (US$0.63) compared toRMB3.88 (US$0.57) in 2009.
Fourth Quarter 2010 Financial Highlights:
- Total net revenues in the fourth quarter of 2010 increased by 36.2% to
RMB101.2million (US$15.3 million ), compared toRMB74.3 million (US$10.9 million ) in the fourth quarter of 2009. - GAAP operating income in the fourth quarter of 2010 decreased by 60.6% to
RMB3.9 million (US$0.6 million RMB9.9 million (US$1.5 million ) in the fourth quarter of 2009. Non-GAAP operating income increased by 40.4% toRMB13.9 million (US$2.1 million ), compared to non-GAAP operating income ofRMB9.9 million (US$1.5 million ) in the fourth quarter of 2009. The difference between GAAP and non-GAAP operating income is due to the expensing of theUS$1.5 million initial payment to acquire exclusive rights to all transplant and autoimmune indications of voclosporin in mainlandChina ,Hong Kong andTaiwan . - GAAP net income in the fourth quarter of 2010 decreased by 51.1% to
RMB6.7 million (US$1.0 million ), compared to GAAP net income ofRMB13.7 million (US$2.0 million ) in the fourth quarter of 2009. Non-GAAP net income in the fourth quarter of 2010 increased by 52.3% toRMB16.6 million (US$2.5 million ), compared to non-GAAP net income ofRMB10.9 million (US$1.6 million ) in the fourth quarter of 2009. - GAAP net income per ADS on a fully-diluted basis in the fourth quarter of 2010 was
RMB0.30 (US$0.05) compared to a net income per ADS on a fully-diluted basis ofRMB0.63 (US$0.09) for the fourth quarter of 2009. Non-GAAP net income per ADS on a fully-diluted basis in the fourth quarter of 2010 wasRMB0.74 (US$0.11) , compared to non-GAAP net income per ADS on a fully-diluted basis ofRMB0.50 (US$0.07) in the fourth quarter of 2009.
Full Year 2010 Business Highlights
Operations
- EPIAO, the Company's flagship injectable recombinant human erythropoietin ("EPO") product, demonstrated strong growth with net revenues in 2010 rising 27.9% to
RMB250.9 million (US$38.0 million ), compared toRMB196.1 million (US$28.7 million ) in 2009. According to the latest data from IMS Health China, EPIAO's market share in terms of value reached 41.0% in the fourth quarter of 2010. - Net revenues for TPIAO, the Company's novel recombinant human thrombopoietin ("TPO") product, increased by 43.5% to
RMB128.7 million (US$19.5 million ) in 2010, compared toRMB89.7 million (US$13.1 million ) in 2009. - Net revenues for Iron Sucrose Supplement increased by 60.4% to
RMB17.2 million (US$2.6 million ), 4.1% of net revenues in 2010, compared toRMB10.7 million (US$1.6 million ), or 3.4% of net revenues in 2009. - Net export revenues decreased slightly to
RMB12.2 million (US$1.8m ), accounting for 2.9% of total net revenue in 2010, compared toRMB13.2 million (US$1.9 million ), or 4.2% of net revenues in 2009.
Regulatory
- An application for a registration trial for Feraheme was submitted in
January 2010 to theChinese State Food and Drug Administration ("SFDA"). Feraheme is a new generation IV iron therapy licensed through a strategic partnership withAMAG Pharmaceuticals . - An application was submitted to the SFDA in
February 2010 to conduct Phase I clinical trials for NuPIAO, the Company's second generation EPO product.
Manufacturing
- In
August 2010 , the SFDA granted GMP certification for the new factory inShenyang . GMP certification will support the future growth of EPIAO and TPIAO inChina and serve as an important step towards exploring global biosimilar opportunities.
Partnerships and Business Development
- A strategic alliance was formed in
February 2010 withAscentage Pharma Group Corporation Ltd ("APGC") to research, develop and commercialize cancer therapeutics focused on programmed cell death, or apoptosis. 3SBio invested a total consideration ofUS$3 million in APGC through equity investment and R&D contracts. InDecember 2010 , APGC announced the formation of a strategic collaboration withAscenta Pharmaceuticals ("Ascenta") to develop Ascenta's clinical stage, apoptosis-triggering small molecules, AT-101 and AT-406, inChina . AT-101 is a pan-Bcl-2 inhibitor in Phase II development for several cancers. Regulatory approval for clinical development of AT-101 has already been granted by the Chinese SFDA and Phase II clinical trials are expected to begin inChina soon. AT-406 is a multi-IAP inhibitor (including XIAP, cIAP1, cIAP2, ML-IAP). An Investigational New Drug ("IND") application for AT-406 was recently submitted inChina . APGC will acquire the exclusive rights to AT-406 in mainlandChina ,Hong Kong ,Taiwan andMacau , as well as exclusive rights to AT-101 in all regions worldwide outsideUSA ,Canada andEurope . - In
August 2010 , 3SBio announced a licensing, development and commercialization agreement withIsotechnika Pharma Inc. ("Isotechnika") (TSX: ISA), aToronto Stock Exchange -listed company for voclosporin, a treatment to prevent organ rejection following transplantation and other autoimmune diseases. 3SBio made aUS$4.5 million investment in a convertible note which was fully converted beforeDecember 31, 2010 , bringing 3SBio's shareholding to 30,734,877 shares. As ofDecember 31, 2010 , 3SBio owned 18.94% of Isotechnika. 3SBio also made an up-front payment ofUS$1.5 million inDecember 2010 to acquire the exclusive rights to certain indications of voclosporin inGreater China , includingHong Kong andTaiwan from Isotechnika. - In
November 2010 , 3SBio purchased the assets of EnzymeRx for a total consideration ofUS$6.25 million , including the worldwide rights excludingTaiwan to all indications of pegsiticase (Uricase-PEG 20), a treatment for refractory gout, tumor lysis syndrome, and Lesch-Nyhan syndrome. Pegsiticase (Uricase-PEG 20) is a pegylated recombinant uricase derived from Candida utilis, modified by the attachment of multiple 20 kilodalton molecules of polyethylene glycol ("PEG"). Gout is a common rheumatic disease inChina with prevalence of gout and hyperuricemia estimated to be 0.22%–0.43% and 12.1%–25.2% respectively. The number of patients inChina suffering from gout and hyperuricemia is expected to continue to grow rapidly due to changes in diet and lifestyle. 3SBio intends to apply to the SFDA to conduct trials for pegsticase inChina and will seek partnerships for development outside ofChina . - The Taiwanese regulatory authorities did not approve a previously announced interest in investing
US$1 million equity investment in Panacor Bioscience, aTaiwan -based pharmaceutical company, and consequently no payments have been incurred to date on the related Nephoxil deal.
Events subsequent to
-- The SFDA granted manufacturing approval in
Dr.
Full Year Ended December 31, 2010 Unaudited Financial Results
Net revenues. Net revenues for 2010 increased by 32.1% to
Net revenues from EPIAO in 2010 increased by 27.9% to
Gross profit. Gross profit for 2010 increased by 29.3% to
Operating expenses.GAAP operating expenses were
- Research and development ("R&D") costs. GAAP R&D costs for 2010 were
RMB39.4 million (US$6.0 million ), or 9.4% of net revenues, compared toRMB19.4 million (US$2.8 million ), or 6.1% of net revenues in 2009. Non-GAAP R&D costs for 2010 wereRMB29.5 million (US$4.5 million ), or 7.0% of net revenues, compared toRMB19.4 million (US$2.8 million ), or 6.1% of net revenues in 2009. The difference between GAAP and non-GAAP R&D expense is due to the expensing of theUS$1.5 million up-front payment to acquire exclusive rights to all transplant and autoimmune indications of voclosporin in mainlandChina ,Hong Kong andTaiwan from Isotechnika. The increase in both GAAP and non-GAAP R&D costs is also attributable to expensing in 2010 ofRMB5.0 million of theRMB17.0 million prepayment made to APGC pursuant to the R&D contracts, based on R&D activities performed to date. - Sales, marketing and distribution expenses. Sales, marketing and distribution expenses for 2010 were
RMB193.2 million (US$29.3 million ), or 46.2% of net revenues, compared toRMB150.3million (US$22.0 million ), or 47.4% of net revenues in 2009. The increase in sales, marketing and distribution expenses is broadly in line with overall sales growth. - General and administrative expenses. General and administrative expenses for 2010 were
RMB55.9 million (US$8.5 million ), or 13.3% of net revenues, compared toRMB36.2 million (US$5.3 million ), or 11.4% of net revenues in 2009. The increase in general and administrative expenses is mainly attributable to employee compensation, legal, auditing and office renovation expenses.
Operating income. GAAP operating income for 2010 increased by 2.9% to
Interest income. The Company recorded interest income of
Net income.GAAP net income for 2010 decreased by 2.6% to
Non-GAAP net income for 2010 increased by 9.0% to
Cash and cash equivalents, restricted cash and time deposits. 3SBio had positive operating cash flow of
Three Months Ended
Net revenues. Net revenues increased by 36.2% to
Gross profit. As a result of continued sales growth from key products, gross profit for the fourth quarter of 2010 increased by 30.5% to
Operating expenses.GAAP operating expenses were
- Research and development ("R&D") costs. GAAP R&D costs for the fourth quarter of 2010 were
RMB17.2 million (US$2.6 million), or 17.0% of net revenues, compared toRMB5.1 million (US$0.7 million ), or 6.9% of net revenues, for the same period in 2009. Non-GAAP R&D costs for the fourth quarter of 2010 wereRMB7.2 million (US$1.1 million ), or 7.1% of net revenues, compared toRMB5.1 million (US$0.7 million ), or 6.9% of net revenues, for the same period in 2009. The difference between GAAP and non-GAAP R&D is due to the expensing of theUS$1.5 million up-front payment to acquire exclusive rights to certain indications of voclosporin in mainlandChina ,Hong Kong andTaiwan . - Sales, marketing and distribution expenses. Sales, marketing and distribution expenses for the fourth quarter of 2010 were
RMB50.6 million (US$7.7 million ), or 50.0% of net revenues, compared toRMB40.7 million (US$6.0 million ), or 54.8% of net revenues, for the same period in 2009. - General and administrative expenses. General and administrative expenses for the fourth quarter of 2010 were
RMB16.8 million (US$2.5 million ), or 16.6% of net revenues, compared toRMB12.1 million (US$1.8 million ), or 16.2% of net revenues for the same period in 2009.
Operating income. GAAP operating income for the fourth quarter of 2010 decreased 60.6% to
Interest income. The Company recorded interest income of
Net income.GAAP net income for the fourth quarter of 2010 decreased 51.1% to
Non-GAAP net income for the fourth quarter of 2010 was 2011 Full Year Guidance and Selected Company Objectives Based on current market and operating conditions and the following goals, the Company's total net revenues target for the full year 2011 is between Conference Call 3SBio's senior management will host a conference call at Conference ID: 46216099 Local dial-in: China landline 800-819-0121 China mobile 400-620-8038 Hong Kong 852-2475-0994 International toll-free dial-in: Hong Kong 800930346 United Kingdom 080-8234-6646 United States 1-866-519-4004 International toll dial-in: 65 6723 9381 Replay- Conference ID:46216099 A telephone replay will be available two hours after the call until International dial-in: 61-2-8235-5000 United States dial-in: 1-866-214-5335 Webcast A live webcast of the conference will be available on the investor relations page of 3SBio's website at http://bbs.3sbio.com/en/News/xinvestors.aspx and at http://tinyurl.com/3SBio2010Q4. A replay of the webcast will be available within one hour after the conclusion of the call. Non-GAAP Financial Measures: Reconciliation of GAAP to Non-GAAP To supplement the Company's financial information presented in accordance with generally accepted accounting principles ("GAAP"), the Company has utilized some non-GAAP financial measures to provide investors and management with supplemental measures that facilitate comparisons of operating performance and trends with prior and future operating performance, and that may not otherwise be apparent on a GAAP basis. These non-GAAP financial measures include non-GAAP operating expenses, non-GAAP operating income, non-GAAP net income, non-GAAP net income per share, and non-GAAP net income per ADS. These measures may be different from non-GAAP financial measures used by other companies. The presentation of this financial information, which is not prepared under any comprehensive set of accounting rules or principals, is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with GAAP. Non-GAAP measures have limitations in that they do not reflect all of the amounts associated with the Company's results of operations as determined in accordance with GAAP. These measures should only be used to evaluate the Company's results of operations in conjunction with the corresponding GAAP measures. Please see the attached reconciliation of GAAP to non-GAAP for an explanation of the amounts excluded to arrive at non-GAAP financial measures for the three-month periods ended Statement Regarding Unaudited Financial Information The unaudited financial information set forth above is preliminary and subject to adjustments and modifications. The audited financial statements and related notes are to be included in the Company's annual report on Form 20-F for the year ending December 31, 2010. Adjustments and modifications to the financial statements may be identified during the course of the audit work, which could result in significant differences from this preliminary unaudited financial information. Currency Convenience Translation For the convenience of readers, certain RMB amounts have been translated into US dollars at the rate of About 3SBio is a leading, fully integrated, profitable biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products primarily in Safe Harbor Statement Certain statements in the disclosures of These forward-looking statements address activities, events, conditions, or developments that we currently expect or anticipate may occur in the future, and include, but may not be limited to, discussions and statements regarding full year revenue target, business growth and prospects, operation objectives, market size or patient number estimates or illness prevalence, product development risks, pipeline progress, regulatory approval and review progress,impact of the government policies and regulations, partnerships or collaborations and the outcome thereof, capital expense estimate, future operations, investment portfolio management, and future strategies. Forward-looking statements can be identified by such terminology as "believe," "expect," "plans," "strategy," "potential", "prospects," "forecast," "estimate," "project," "anticipate," "aim," "will" or "would", "may" or "might", and words, phrases, expressions, and usages of similar meaning or substance or the negative of such words, phrases, expressions and usages. Forward-looking statements are based on management's current assumptions, beliefs, expectations, and projections, in light of the information currently available, and actual results, performances, or achievements could differ materially from those implied or expressed by the forward-looking statements. Among the factors that could cause actual results to differ from what the Company currently anticipates may include competition from other domestic and foreign pharmaceutical companies; the market growth for pharmaceutical products in For additional information on factors identified above and other risk factors, uncertainties and assumptions, please refer to the Company's filings with the All the statements in the Disclosures speak as of the date of the initial release, even if subsequently made available on the 3SBio website or otherwise. 3SBio undertakes no obligation to update or revise these forward-looking statements, whether as a result of new information, subsequent events or otherwise, after the date of this press release. Investor Contacts Bo Tan Tom Folinsbee 3SBio Inc. Consolidated balance sheets (expressed in thousands) December 31
December 31 2010 December 31 2010 RMB RMB US$ Assets (unaudited) (unaudited) Current assets Cash and cash equivalents 262,767 153,250 23,220 Restricted cash 9,300 1,662 252 Time deposits with financial institutions 468,451 378,405 57,334 Notes receivable 31,265 55,646 8,431 Accounts receivable, less allowance for doubtful accounts: December 31, 2009 – RMB2,915;December 31 , 2010– RMB2,663(US$403) 54,661 78,500 11,894 Inventories 15,406 21,718 3,291 Prepaid expenses and other receivables 8,705 51,390 7,786 Available-for-sale securities - 50,667 7,677 Deferred tax assets 2,079 2,198 333 Total current assets 852,634 793,436 120,218 Time deposits with financial institutions - 120,000 18,182 Available-for-sale securities 11,407 12,697 1,924 Investment in non-consolidated affiliates - 3,835 581 Property, plant and equipment, net 165,120 199,456 30,221 Lease prepayments 8,541 8,188 1,241 Non-current deposits 10,067 1,555 236 Intangible assets, net 4,125 44,299 6,712 Long term receivable - 2,558 388 Deferred tax assets 1,567 373 57 Total assets 1,053,461 1,186,397 179,760 Liabilities Current liabilities Accounts payable 2,736 5,030 762 Deferred grant income 374 1,374 208 Accrued expenses and other payables 33,421 39,552 5,993 Income tax payable 1,914 1,986 301 Total current liabilities 38,445 47,942 7,264 Deferred grant income 2,778 2,402 364 Total liabilities 41,223 50,344 7,628 Commitments and contingencies - - - Shareholders' equity Share capital - ordinary shares US$0.0001 par value, 500,000,000 shares authorized, 150,641,461 and 152,654,148issued and outstanding as of December 31, 2009 and December 31, 2010, respectively 121 123 19 Additional paid-in capital 915,267 946,717 143,442 Accumulated other comprehensive loss (100,608) (89,531) (13,563) Retained earnings 197,458 278,744 42,234 To Total shareholders' equity 1,012,238 1,136,053 172,132 Total liabilities and shareholders' equity 1,053,461 1,186,397 179,760 3SBio Inc. Consolidated statements of income (expressed in thousands, except per share , per ADS and other share and ADS data) For the Three Months Ended For the Three Months Ended December 31,2009 December 31,2010 RMB US$ RMB US$ (unaudited) (unaudited) (unaudited) (unaudited) Net Revenues: EPIAO 45,531 6,670 61,495 9,317 TPIAO 20,859 3,056 30,836 4,672 Intefen 1,334 195 1,182 179 Inleusin 441 65 466 71 Iron sucrose 2,015 295 3,843 582 Export 4,083 598 2,821 427 Others 13</span> 2 546 83 Total net revenues 74,276 10,881 101,189 15,331 Cost of revenues (6,494) (951) (12,740) (1,930) Gross profit 67,782 9,930 88,449 13,401 Operating expenses Research and development costs (5,102) (747) (17,193) (2,605) Sales, marketing and distribution expenses (40,689) (5,961) (50,580) (7,664) General and administrative expenses (12,058) (1,767) (16,757) (2,539) Total operating expenses (57,849) (8,475) (84,530) (12,808) Operating income 9,933 1,455 3,919 593 Other income Interest income 2,172 318 3,193 484 Grant income 393 58 975 148 Other income 329 48 1,580 239 Total other income 2,894 424 5,748 871 Income before income tax benefit/(expense) 12,827 1,879 9,667 1,464 Income tax benefit/(expense) 823 121 (2,980) (451) Net income 13,650 2,000 6,687 1,013 Net income per share:</p> Basic 0.09 0.01 0.04 0.01 Diluted 0.09 0.01 0.04 0.01 Basic weighted average number of shares outstanding 150,628,974 150,628,974 152,269,537 152,269,537 Diluted weighted average number of sharesoutstanding 152,686,775 152,686,775 156,490,935 156,490,935 Net income per ADS: Basic 0.63 0.09 0.31 0.05 Diluted 0.63 0.09 0.30 0.05 Basic weighted average number of ADSs outstanding 21,518,425 21,518,425 21,752,791 21,752,791 Diluted weighted average number of ADSs outstanding 21,812,396 21,812,396 22,355,848 22,355,848 3SBio Inc. Consolidated statements of income (expressed in thousands, except per share , per ADS and other share and ADS data) For the full year Ended For the full year Ended December 31,2009 December 31,2010 RMB US$ RMB US$ (unaudited) (unaudited) Net Revenues: EPIAO 196,080 28,726 250,854 38,008 TPIAO 89,679 13,138 128,717 19,503 Intefen 5,522 809 5,358 812 Inleusin 1,607 235 2,041 309 Iron sucrose 10,715 1,570 17,187 2,604 Export 13,216 1,936 12,211 1,850 Others 101 15 2,260 342 Total net revenues 316,920 46,429 418,628 63,428 Cost of revenues (26,584) (3,895) (43,311) (6,562) Gross profit 290,336</p> 42,534 375,317 56,866 Operating expenses Research and development costs (19,427) (2,846) (39,409) (5,971) Sales, marketing and distribution expenses (150,331) (22,023) (193,216) (29,275) General and administrative expenses (36,195) (5.303) (55,850) (8,462) Total operating expenses (205,953) (30,172) (288,475) (43,708) Operating income 84,383 12,362 86,842 13,158 Other income/(expense), net Interest income 10,319 1,512 12,355 1,872 Grant income 674 99 1,256 190 Net realized gain on available-for- sale securities 1,611 236 - - Impairment loss on available-for-salesecurities (4,624) (677) - - Other income 2,808 411 2,605 395 Total other income/(expense), net 10,788 1,581 16,216 2,457 Income before income tax expense 95,171 13,943 103,058 15,615
(11,736) (1,719) (21,772) (3,299) Net income 83,435 12,224 81,286 12,316 Net income per share: Basic 0.55 0.08 0.54 0.08 Diluted 0.55 0.08 0.53 0.08 Basic weighted average number of shares outstanding 150,606,317 150,606,317 151,241,036 151,241,036 Diluted weighted average number of sharesoutstanding 151,034,192 151,034,192 154,131,768 154,131,768 Net income per ADS: Basic 3.87 0.57 3.76 0.57 Diluted 3.87 0.57 3.69 0.56 Basic weighted average number of ADSs outstanding 21,515,188 21,515,188 21,605,862 21,605,862 Diluted weighted average number of ADSs outstanding 21,576,313 21,576,313 22,018,824 22,018,824 Reconciliations of GAAP operating income and net income to non-GAAP operating income and net income for three months ended December 31, 2009 and 2010 (in RMB thousands, unaudited) For the three months ended December 31, 2009 For the three months ended December 31, 2010 GAAP Adjustment Non-GAAP GAAP Adjustment Non-GAAP RMB US$ RMB RMB US$ RMB US$ RMB RMB US$ Operating income 9,933 1,455 - 9,933 1,455 3,919 593 9,944 13,863 2,098 Net income 13,650 2,000 (2,750) 10,900 1,597 6,687 1,013 9,944 16,631 2,520 The adjustment for the three months ended The adjustment for the three months ended Reconciliations of GAAP operating income and net income to non-GAAP operating income and net income for the full year of 2009 and 2010 (in RMB thousands, unaudited) For the full year ended December 31, 2009 For the full year ended December 31, 2010 GAAP Adjustment Non-GAAP GAAP Adjustment Non-GAAP RMB US$ RMB RMB US$ RMB US$ RMB RMB US$ Operating income 84,383 12,362 - 84,383 12,362 86,842 13,158 9,944 96,786 14,665 Net income 83,435 12,2245 263 83,698 12,262 81,286 12,316 9,944 91,230 13,823 The adjustment for the full year ended The adjustment for the full year ended SOURCE
Chief Financial Officer
3SBio Inc.
Tel: + 86 24 2581-1820
[email protected]
Director of Investor Relations
3SBio Inc.
Tel: + 852 8191-6991
[email protected]
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