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CSPC Pharmaceutical Group Limited Interim / Quarterly Report 2021

May 24, 2021

49680_rns_2021-05-24_1225617b-136f-4a37-9bed-4ef134423213.pdf

Interim / Quarterly Report

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Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no responsibility for the contents of this announcement, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this announcement.

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CSPC PharmaCeutiCal GrouP limited 石藥集團有限公司

(Incorporated in Hong Kong under the Companies Ordinance)

(Stock code: 1093)

QuarterlY reSultS For the three moNthS eNded 31 marCh 2021

FiNaNCial hiGhliGhtS

Revenue by business units:
Finished drugs
Bulk products
— Vitamin C
— Antibiotics and others
Functional food and others
Total revenue
Underlying profit_(Note)_
Gain on disposal of a subsidiary (after tax)
Profit attributable to shareholders
Earnings per share
— Basic
— Diluted
For the three months
ended 31 march
2021
2020
RMB’000
RMB’000
Change
(unaudited)
(Unaudited)
5,479,845
5,021,745
+9.1%
523,859
426,297
+22.9%
389,288
297,240
+31.0%
340,545
379,951
-10.4%
6,733,537
6,125,233
+9.9%
1,471,528
900,876
+63.3%

258,574
1,471,528
1,159,450
+26.9%
RMB cents
RMB cents
(Restated)
12.29
9.68
+27.0%
12.29
9.68
+27.0%

Note: Underlying profit, a non-HKFRS measure, represents profit before taking into account gain on disposal of a subsidiary.

— 1 —

The Board of Directors of CSPC Pharmaceutical Group Limited (the “Company”) is pleased to announce the unaudited consolidated results of the Company and its subsidiaries (the “Group”) for the three months ended 31 March 2021 as follows:

CoNdeNSed CoNSolidated StatemeNt oF ProFit or loSS

For the three months ended 31 March 2021

Revenue
Cost of sales
Gross profit
Other income
Other gains or losses
Selling and distribution expenses
Administrative expenses
Research and development expenses
Other expenses
Share of results of joint ventures
Share of results of associates
Gain on disposal of a subsidiary
Finance costs
Profit before tax
Income tax expense
Profit for the period
Profit for the period attributable to:
Owners of the Company
Non-controlling interests
Earnings per share
— Basic
— Diluted
For the three months
ended 31 march
2021
2020
RMB’000
RMB’000
(unaudited)
(Unaudited)
6,733,537
6,125,233
(1,549,407)
(1,595,952)
5,184,130
4,529,281
50,333
35,025
98,285
34,973
(2,620,356)
(2,550,933)
(216,760)
(277,784)
(691,293)
(568,138)
(13,804)
(39,675)
10,082
8,412
(13,739)
96

286,232
(2,833)
(2,177)
1,784,045
1,455,312
(286,427)
(283,175)
1,497,618
1,172,137
1,471,528
1,159,450
26,090
12,687
1,497,618
1,172,137
RMB cents
RMB cents
(Restated)
12.29
9.68
12.29
9.68

— 2 —

CoNdeNSed CoNSolidated StatemeNt oF ProFit or loSS aNd other ComPreheNSive iNCome

For the three months ended 31 March 2021

Profit for the period
other comprehensive income
Item that will not be reclassified to profit or loss:
Fair value gain on financial assets measured at fair value
through other comprehensive income, net of tax
Item that may be reclassified subsequently to profit or loss:
Exchange differences on translation of foreign operations
Other comprehensive income for the period, net of income
tax
Total comprehensive income for the period
Total comprehensive income for the period attributable to:
Owners of the Company
Non-controlling interests
For the three months
ended 31 march
2021
2020
RMB’000
RMB’000
(unaudited)
(Unaudited)
1,497,618
1,172,137
24,361
63,045
15,465
(1,663)
39,826
61,382
1,537,444
1,233,519
1,511,354
1,220,832
26,090
12,687
1,537,444
1,233,519

— 3 —

Notes:

1. PriNCiPal aCCouNtiNG PoliCieS

The principal accounting policies and methods of computation used in the preparation of the financial data for the three months ended 31 March 2021 are consistent with those followed in the preparation of the Group’s financial statements for the year ended 31 December 2020.

2. reveNue aNd SeGmeNt iNFormatioN

Information reported to executive directors, being the chief operating decision maker (“CODM”), for the purposes of resources allocation and assessment of segment performance focuses on types of goods delivered. The reportable segments of the Group are as follows:

  • (a) Finished drugs — research and development, manufacture and sale of pharmaceutical products;

  • (b) Bulk products — manufacture and sale of vitamin C, antibiotic and other products in bulk powder form;

  • (c) Functional food and others — manufacture and sale of functional food products (including caffeine additives and vitamin supplements), provision of healthcare services and others.

The following is an analysis of the Group’s revenue and results by operating and reportable segment.

For the three months ended 31 March 2021 (Unaudited):

SEGMENT REVENUE
External sales
Inter-segment sales
TOTAL REVENUE
SEGMENT PROFIT
Unallocated income
Unallocated expenses
Share of results of joint ventures
Share of results of associates
Finance costs
Profit before tax
Bulkproducts
Functional
Finished
antibiotics
food and
drugs
vitamin C
and others
others
RMB’000
RMB’000
RMB’000
RMB’000
5,479,845
523,859
389,288
340,545

1,978
20,775
5,415
5,479,845
525,837
410,063
345,960
1,380,971
204,870
26,453
75,909
Segment
total
eliminations Consolidated
RMB’000
RMB’000
RMB’000
6,733,537

6,733,537
28,168
(28,168)

6,761,705
(28,168)
6,733,537
1,688,203
1,688,203
137,385
(35,053)
10,082
(13,739)
(2,833)
1,784,045

— 4 —

For the three months ended 31 March 2020 (Unaudited):

SEGMENT REVENUE
External sales
Inter-segment sales
TOTAL REVENUE
SEGMENT PROFIT
Unallocated income
Unallocated expenses
Share of results of joint ventures
Share of results of associates
Gain on disposal of a subsidiary
Finance costs
Profit before tax
Finished
drugs
RMB’000
5,021,745

5,021,745
1,007,060
Bulkproducts
Antibiotics
Vitamin C
and others
RMB’000
RMB’000
426,297
297,240
1,484
48,709
427,781
345,949
43,479
14,188
Functional
food and
others
RMB’000
379,951
3,249
383,200
84,507
Segment
total
Eliminations
Consolidated
RMB’000
RMB’000
RMB’000
6,125,233

6,125,233
53,442
(53,442)

6,178,675
(53,442)
6,125,233
1,149,234
1,149,234
42,797
(29,282)
8,412
96
286,232
(2,177)
1,455,312

Segment profit represents the profit earned by each segment without allocation of interest income, fair value changes on structured bank deposits, fair value changes on financial assets measured at fair value through profit or loss (“FVTPL”), finance costs, central administrative expenses, share of results of joint ventures and associates and gain on disposal of a subsidiary. This is the measure reported to the CODM for the purposes of resources allocation and performance assessment.

Inter-segment sales are charged at prevailing market rates.

— 5 —

3. ProFit For the Period

Profit for the period has been arrived at after charging (crediting):
Amortisation of other intangible assets
Depreciation of right-of-use assets
Depreciation of property, plant and equipment
Depreciation of investment property
Total depreciation and amortisation
Fair value changes on financial assets measured at FVTPL
(included in other gains or losses)
Fair value changes on structured bank deposits
(included in other gains or losses)
Government grant income (included in other income)
Interest income on bank balances (included in other income)
Net foreign exchange gain (included in other gains or losses)
For the three months
ended 31 march
2021
2020
RMB’000
RMB’000
(unaudited)
(Unaudited)
3,773
3,132
34,481
22,222
174,703
168,260
430

213,387
193,614
(81,260)

(15,011)
(18,021)
(7,879)
(29,935)
(22,660)
(13,913)
(3,998)
(17,674)

Note: Cost of inventories recognised as an expense approximated cost of sales as shown in the condensed consolidated statement of profit or loss for the three months ended 31 March 2021 and 2020.

4. GaiN oN diSPoSal oF a SuBSidiarY

During the three months ended 31 March 2020, the Group entered into sales and purchase agreements with an independent third party to dispose of its 99.39% equity interest in Shijiazhuang Zhongrun Pharmaceutical Technology Limited for a total cash consideration of approximately RMB503,046,000, resulting in a gain of approximately RMB286,232,000.

— 6 —

5. earNiNGS Per Share

The calculation of basic and diluted earnings per share attributable to the owners of the Company is based in the following data:

earnings
Earnings for the purposes of basic and diluted earnings per share
Number of shares
Weighted average number of ordinary shares
for the purpose of basic earnings per share
Effect of dilutive potential ordinary shares:
Unvested shares under share award scheme
Weighted average number of ordinary shares
for the purpose of diluted earnings per share
For the three months
ended 31 march
2021
2020
RMB’000
RMB’000
(unaudited)
(Unaudited)
1,471,528
1,159,450
For the three months
ended 31 march
2021
2020
’000
’000
(Restated)
11,973,770
11,973,770
1,273
1,038
11,975,043
11,974,808
For the three months
ended 31 march
2021
2020
RMB’000
RMB’000
(unaudited)
(Unaudited)
1,471,528
1,159,450
For the three months
ended 31 march
2021
2020
’000
’000
(Restated)
11,973,770
11,973,770
1,273
1,038
11,975,043
11,974,808
11,974,808

Notes:

  • (a) The weighted average number of ordinary shares for the calculation of earnings per share for the three months ended 31 March 2020 has been adjusted for the effect of the bonus issues on 3 July 2020 and 29 October 2020.

  • (b) The weighted average number of ordinary shares for the calculation of earnings per share for the three months ended 31 March 2021 and 2020 has been adjusted for the effect of shares held by the trustee pursuant to the share award scheme of the Company.

  • (c) The calculation of diluted earning per share does not assume the exercise of a subsidiary’s share options since their assumed exercise would result in an increase in earnings per share.

— 7 —

BuSiNeSS revieW

reSultS

For the three months ended 31 March 2021, the Group’s revenue increased by 9.9% to RMB6,734 million and profit attributable to shareholders increased by 26.9% to RMB1,472 million. Basic earnings per share increased similarly to RMB12.29 cents.

Finished drug Business

Under the operating environment of deepening healthcare reform and intensifying market competition, the Group continued to adopt measures such as professional academic promotion, hospital development, lower-tier market penetration, clinical application exploration and professional sales team expansion in order to drive the continuous growth of the finished drug business. For the first quarter of the year, the finished drug business achieved stable growth with sales reaching RMB5,480 million, representing an increase of 9.1% over the same period of last year. The sales performance by therapeutic area is as follows:

Nervous System Disease Products

Major products include NBP (恩必普) (butylphthalide soft capsules and butylphthalide sodium chloride injection), Oulaining (歐來寧) (oxiracetam capsules and oxiracetam for injection), Shuanling (舒安 靈) (pentoxifylline extended-release tablets and pentoxifylline injection), Enxi (恩悉) (pramipexole dihydrochloride tablets) and Oulaituo (歐來妥) (memantine hydrochloride tablets). For the current period, nervous system disease products recorded sales of RMB1,795 million, representing a year-onyear increase of 8.5%, with the sales of NBP increased by 8.7%; Oulaining decreased by 33.8% and Shuanling increased by 647.5%. The new edition of National Reimbursement Drug List was implemented in March, NBP also began to sell at the new market prices. With the strong market foundation laid by the previous continuous academic education, and the significantly improved accessibility and competitiveness of the product after price reduction, sales volume demonstrated a rapid growth trend. The volume of non-reimbursable prescriptions generated by the on-line hospitals established last year has even seen an explosive growth. The fast-growing sales volume is rapidly alleviating the impact of price reduction on results. At the beginning of the year, Enxi won the fourth round of national centralised procurement at an optimal price, having a chance of becoming a new growth drive following its nationwide implementation in May.

— 8 —

Oncology products

Major products include Duomeisu (多美素) (doxorubicin hydrochloride liposome injection), Jinyouli (津優力 ) (PEG-rhG-CSF injection), Keaili (克艾力) (paclitaxel for injection (albumin-bound)) and Wankeda (萬可達) (bortezomib for injection). For the current period, oncology products recorded sales of RMB1,869 million, representing a year-on-year increase of 20.4%, with the sales of Duomeisu increased by 60.1%, Keaili increased by 8.4% (sales volume increased by 252%, product price in the corresponding period of last year was before implementation of the centralised procurement results) and Jinyouli increased by 2.3%.

Anti-infective products

Major products include Shuluoke (舒羅克) (meropenem for injection), Nuomoling (諾莫 靈) (amoxicillin capsules), Xianqu/Shiyao (先曲╱石藥) (ceftriaxone sodium for injection), Zhongnuolixin (中諾立新 ) (cefuroxime sodium for injection), Xinweihong (新維宏) (azithromycin tablets) and Weihong (維宏) (azithromycin dispersible tablets/capsules/enteric tablets). For the current period, anti-infective products recorded sales of RMB701 million, representing a year-onyear decrease of 9.6%.

Cardiovascular disease products

Major products include Xuanning (玄寧) (maleate levamlodipine tablets and dispersible tablets), Encun (恩存) (clopidogrel bisulfate tablets), Daxinning (達新寧) (dronedarone hydrochloride tablets), Abikang (阿比康) (aspirin enteric tablets) and Meiluolin (美洛林) (ticagrelor tablets). For the current period, cardiovascular disease products recorded sales of RMB719 million, representing a year-on-year increase of 23.5%, with the sales of Xuanning increased by 25.5%. Encun has entered the second year of centralised procurement with significant increase in procurement volume quoted in provinces won, driving sales for the current period to increase by 19.9%.

Respiratory disease products

Major products include Qixiao (琦效) (arbidol hydrochloride tablets), Zhongnuolike (中諾立克) (ambroxol hydrochloride oral solution), Zhongnuoping (中諾平) (ambroxol hydrochloride extendedrelease tablets) and Nuoyian (諾一安) (montelukast sodium tablets/chewable tablets). For the current period, respiratory disease products recorded sales of RMB107 million, representing a year-on-year decrease of 44%.

Digestion and metabolism disease products

Major products include Linmeixin (林美欣) (glimepiride dispersible tablets), Shuanglexin (雙樂 欣) (metformin hydrochloride tablets/extended-release tablets), Xinweiping (欣維平) (acarbose tablets) and Debixin (得必欣) (omeprazole enteric capsules). For the current period, digestion and metabolism disease products recorded sales of RMB118 million, representing a year-on-year decrease of 9%.

— 9 —

Products in other therapeutic areas

Major products include Gubang (固邦) (alendronate sodium tablets/enteric tablets), Qimaite (奇邁 特) (tramadol hydrochloride tablets) and Youdening (優德寧) (celecoxib capsules). For the current period, products in other therapeutic areas recorded sales of RMB171 million, representing a yearon-year increase of 23.7%.

Bulk Product Business

Benefited from product price increase, vitamin C products recorded sales of RMB524 million for the current period, representing a year-on-year increase of 22.9%. The sales of antibiotic and other products also increased by 31% to RMB389 million as a result of sales volume increase.

Functional Food and others Business

The business recorded sales of RMB341 million for the current period, representing a year-on-year decrease of 10.4%, mainly due to sales volume decrease.

research and development

With innovation as the core development strategy, the Group has continued to increase its investment in research and development (R&D) in recent years. Such R&D investment has strengthened the product pipeline under development and begun to reach the harvest stage. Since the beginning of the year, the Group has made the following progress in R&D:

  • 1) Anfulike (安複利克) (amphotericin B cholesteryl sulfate complex for injection) obtained drug registration approval in China and was successfully launched on 3 May. Amphotericin B is one of the most effective drugs with the broadest antimicrobial spectrum for prevention and treatment of invasive fungal infections. Compared with same product type available in the domestic market, the product could significantly reduce nephrotoxicity and increase dosage, demonstrating obvious clinical advantages;

  • 2) The application for marketing approval of COPIKTRA (克必妥) (duvelisib capsules) in China was accepted and granted priority review. The product was granted marketing approval by the U.S. Food and Drug Administration (FDA) in September 2018, being the first approved dual PI3K-δ and PI3K-γ inhibitor for treatment of adult patients with relapsed/refractory follicular lymphoma after at least two prior systemic therapies;

  • 3) NBL-012 injection, JMT101 injection, SYHX1901 tablets, JMT601 injection, SG001 (PD1) injection in combination with Keaili for treatment for platinum-resistant relapsed epithelial ovarian cancer, SG001 (PD-1) injection in combination with Duomeisu for treatment for PDL1 positive platinum-resistant relapsed epithelial ovarian cancer, SKLB1028 capsules in combination with azacitidine for treatment-naive AML patients with FLT3 mutation, SKLB1028

— 10 —

capsules in combination with standard treatment “7+3” for treatment-naive AML patients with FLT3 mutation, irinotecan liposome injection (advanced solid tumors), SYHA1811 tablets obtained clinical trial approval in China;

  • 4) JMT601 injection, NBL-012 injection obtained clinical trial approval in the U.S.;

  • 5) SYSA1801 injection, NBL-015 injection obtained orphan-drug designation in the U.S.;

  • 6) Entecavir tablets, esomeprazole magnesium enteric capsules, nintedanib esilate soft capsules, sorafenib tosylate tablets, sitagliptin phosphate tablets, agoliptin benzoate tablets obtained drug registration approval in China;

  • 7) Paroxetine hydrochloride enteric capsules, carbamazepine extended-release tablets obtained ANDA approval in the U.S.; and

  • 8) 11 generic drug products (19 specifications) have passed or deemed to have passed the consistency of quality and efficacy evaluation of generic drugs.

The R&D expenses for the current period amounted to RMB691 million (charged to profit or loss statement), representing a year-on-year increase of 21.7% and accounting for approximately 12.6% of the revenue of the finished drug business. At present, there are around 300 projects in the pipeline, comprising over 40 innovative small molecule drugs, over 40 innovative macromolecule drugs and over 20 drugs of new preparation, primarily focusing on the therapeutic areas of oncology, autoimmunity, psychiatry and neurology, digestion and metabolism, cardio-cerebrovascular system and anti-infectives. There are currently 30 products pending drug registration approval, 39 products under clinical trials (including 31 innovative drugs and 8 drugs of new preparation) and 5 products pending clinical trial approval.

The Group actively files patent applications for its R&D projects. Since the beginning of the year, the Group has filed 72 patent applications (43 domestic, 21 overseas and 8 patent cooperation treaty (PCT) applications); and received 18 authorisations (10 domestic and 8 overseas).

In the three years ahead, the Group is expected to launch more than 60 new products, not less than 15 of which will be key products with market potential exceeding RMB1 billion each. In addition, products developed on the nanotechnology platform, such as mitoxantrone liposomes, docetaxel albumin nanoparticles and paclitaxel albumin nanoparticles (fast dissolving), are all heavyweight products with global patents and great market value. The launch of these products will certainly provide strong support to the Group’s high-quality growth in the future.

— 11 —

Business development

The Group is actively looking for acquisition and cooperation opportunities to strengthen its product pipeline and make full use of its strong sales platform. During the first quarter, the Group has obtained licenses and commercialisation rights for Rezivertimib Mesylate Capsules (a third generation irreversible EGFR-TKI) and CM310 (an anti-IL-4Rα recombinant humanized antibody). The application for marketing approval of Rezivertimib Mesylate Capsules in China has been accepted in May 2021.

revieW oF reSultS

The financial data for the three months ended 31 March 2021 is based on the internal records and management accounts of the Group and has not been reviewed or audited by the external auditor of the Company.

By order of the Board CSPC Pharmaceutical Group limited Cai dongchen Chairman

Hong Kong, 24 May 2021

As at the date of this announcement, the Board comprises Mr. CAI Dongchen, Mr. ZHANG Cuilong, Mr. WANG Zhenguo, Mr. PAN Weidong, Mr. WANG Huaiyu, Dr. LI Chunlei, Dr. WANG Qingxi, Mr. CHAK Kin Man and Dr. JIANG Hao as executive directors; and Mr. WANG Bo, Mr. CHEN Chuan, Prof. WANG Hongguang, Mr. AU Chun Kwok Alan and Mr. LAW Cheuk Kin Stephen as independent non-executive directors.

— 12 —