Simcere Pharmaceuticals (NYSE:SCR)

PRINCETON, N.J. and NANJING, China, June 14, 2013 /PRNewswire/ -- Bristol-Myers Squibb Company (NYSE: BMY) and Simcere Pharmaceutical Group (NYSE: SCR), a leading pharmaceutical company in China, today announced that the companies have expanded their strategic relationship formed in 2010. The companies have agreed to collaborate in China on the development and commercialization of the subcutaneous (SC) formulation of Bristol-Myers Squibb's biologic medicine, Orencia� (abatacept), for the treatment of rheumatoid arthritis. Orencia SC is already on the market for the treatment of rheumatoid arthritis in the U.S., Europe andJapan.

Under the terms of the agreement, Simcere will perform and fund all development and regulatory activities required to obtain market approval for Orencia SC in China, based on a pre-agreed development plan. The companies will share responsibility for commercializing Orencia, and will share profits and losses related to Orencia SC in China. Financial terms were not disclosed.   

"Orencia SC is the third program in our R&D collaboration with Bristol-Myers Squibb, underscoring our joint commitment to our broad strategic partnership," commented Mr. Hongquan Liu, the CEO of Simcere. "Combining Orencia SC with our existing portfolio in rheumatoid arthritis treatment, we are committed to delivering more innovative and effective medicines to Chinese patients."

Mr. Hongquan Liu further commented, "Moving forward, we will continue to execute on our partnering strategy and to bring in more late-stage programs and products already approved outside of China, to complement our R&D pipeline and strengthen our in-market portfolio."

"We are pleased to partner with Simcere on Orencia SC, moving beyond our companies' original focus on early development activities to a partnership focused on the clinical development and commercialization of one of our currently marketed products," saidBeatrice Cazala, executive vice president, Commercial Operations. "If successful, not only could Orencia SC bring a new option to Chinese patients suffering from rheumatoid arthritis, but also it could become Bristol-Myers Squibb's first biologic medicine for the Chinese market."

First Quarter 2012 Financial Results

• Total revenue was RMB528.7 million (US$85.1 million) for the first quarter of 2013, compared to RMB487.6 million for the same period in 2012, representing an increase of 8.4%. 
• Gross margin for the first quarter of 2013 was 79.2%, compared to 82.0% for the same period in 2012.
• Income from operations was RMB50.2 million (US$8.1 million) for the first quarter of 2013, compared toRMB43.3 million for the same period in 2012, representing an increase of 16.0%.
• Net income attributable to Simcere was RMB29.9 million (US$4.8 million) for the first quarter of 2013, an increase of 4.6% from RMB28.6 million for the same period in 2012.
• Basic and diluted earnings per American Depository Share ("ADS") for the first quarter of 2013 were RMB0.57(US$0.09) and RMB0.56 (US$0.09), respectively. One ADS represents two ordinary shares of the Company.

Mr. Hongquan Liu, Executive Director and Chief Executive Officer of Simcere Pharmaceutical Group, commented, "We experienced moderate sales growth in the first quarter despite sustained pricing restrictions from the government and intensifying competition. I am pleased that our overall business performance improved during the quarter and that both Sales and Marketing expenses and General and Administrative expenses as percentages of our total revenue decreased slightly."

On March 11, 2013, the Company announced that it received a "going private" proposal. Simcere's Board of Directors has formed a special committee to consider the proposed transaction.

NANJING, China, April 3, 2013 /PRNewswire/ -- Simcere Pharmaceutical Group ("Simcere" or the "Company") (NYSE: SCR), a leading pharmaceutical company specializing in the development, manufacturing, and marketing of branded and proprietary pharmaceuticals in China, today announced that its Special Committee of the Board of Directors (the "Special Committee"), which was formed to consider a proposal by Mr. Jinsheng Ren , New Good Management Limited, Assure Ahead Investments Limited and its affiliates (the "Buyer Group"), pursuant to which the Buyer Group proposes to acquire all of the outstanding ordinary shares of the Company not currently owned by the Buyer Group, and any potential alternative transactions involving the Company, has retained UBS AG and/or its affiliates as its exclusive financial advisor to assist it in its work. No decisions have been made by the Special Committee with respect to the Company's response to the proposed transaction. There can be no assurance that any definitive offer will be made, that any agreement will be executed or that this or any other transaction will be approved or consummated.

NANJING, China, March 11, 2013 /PRNewswire/ -- Simcere Pharmaceutical Group ("Simcere" or the "Company") (NYSE: SCR), a leading pharmaceutical company specializing in the development, manufacturing, and marketing of branded and proprietary pharmaceuticals in China, today announced that its Board of Directors has received a non-binding proposal letter from Mr. Jinsheng Ren, New Good Management Limited, Assure Ahead Investments Limited and its affiliates (the "Buyer Group"), pursuant to which the Buyer Group proposes to acquire all of the outstanding ordinary shares of the Company not currently owned by the Buyer Group, for $9.56 per American Depositary Share ("ADS") or $4.78 per ordinary shares in cash. New Good Management Limited is a British Virgin Islands company controlled by Mr. Jinsheng Ren, Chairman of the Board of Directors of the Company.

According to the proposal letter, which is dated March 11, 2013, the Buyer Group will form a transaction vehicle for the purpose of pursuing the proposed transaction, which is intended to be financed with a combination of debt and equity capital.

The Company's Board of Directors has formed a special committee of independent directors (the "Special Committee") consisting of Alan Au and Guoqiang Lin to consider the proposed transaction. The Special Committee has appointed Alan Au as its chairman. The Special Committee intends to retain advisors, including an independent financial advisor and legal counsel, to assist it in its work. No decisions have been made by the Special Committee with respect to the Company's response to the proposed transaction. There can be no assurance that any definitive offer will be made, that any agreement will be executed or that this or any other transaction will be approved or consummated.

Fourth Quarter

• Total revenue was RMB540.1 million (US$86.7 million) for the fourth quarter of 2012, compared to RMB511.0 million for the same period in 2011, representing an increase of 5.7%.
• Gross margin for the fourth quarter of 2012 was 81.1%, compared to 82.3% for the same period in 2011. For the full year of 2012, gross margin was 82.7%, compared to 83.9% in 2011.
• Loss from operations for the fourth quarter of 2012 was RMB78.2 million (US$12.5 million), primarily due to a non-cash impairment charge of RMB97.2 million(US$15.6 million)
• Net loss attributable to Simcere for the fourth quarter of 2012 was RMB20.8 million (US$3.3 million), compared to net income attributable to Simcere of RMB42.8 million for the same period in 2011
• Basic and diluted net loss per American Depository Share ("ADS") for the fourth quarter of 2012 were RMB 0.40(US$0.06) and RMB 0.39 (US$0.06), respectively. Basic and diluted earnings per ADS for the full year of 2012 wereRMB1.06 (US$0.17) and RMB1.06 (US$0.17), respectively. One ADS represents two ordinary shares of the Company.

Mr. Hongquan Liu, Executive Director and Chief Executive Officer of Simcere Pharmaceutical Group, commented, "With the ongoing implementation of a series of healthcare reform policies, drug prices continued to trend down in 2012. Despite the challenging environment and intense competition, our sales in the fourth quarter grew moderately. While we believe market conditions will remain challenging in 2013, our priorities will continue to be strengthening promotion of our key products, accelerating market access and hospital listings, and reducing costs."

The Company also announced that Mr. Alan Au joined the Company as an independent director and chairman of the audit committee in March 2013. Mr. Au has over 15 years of experience in the financial service and investment sectors relating to healthcare in Asia. He is a Certified Public Accountant in the U.S. and holds the Chartered Financial Analyst designation. Mr. Au received his Bachelor's degree in Psychology from the Chinese University of Hong Kong in 1995, and a Master's degree in Management from Columbia University in 2007.

NANJING, China, Jan. 22, 2013 /PRNewswire/ -- Simcere Pharmaceutical Group ("Simcere" or the "Company") (NYSE: SCR), a leading pharmaceutical company specializing in the development, manufacturing, and marketing of branded and proprietary pharmaceuticals in China, today announced that the Company entered into a share transfer agreement with Devont Asset Management Limited on January 15^th 2013 to sell an approximately 35% equity interest in Shanghai Celgen Bio-Pharmaceutical Co., Ltd. ("Shanghai Celgen") for a cash consideration of RMB 302 million. Simcere indirectly acquired an approximately 35% equity interest in Shanghai Celgen in August 2009. Upon completion of this transaction, Simcere will no longer hold any equity interest in Shanghai Celgen. Consummation of the transaction is subject to certain closing conditions.  

2012 Third Quarter Financial Results

• Total revenue for the third quarter of 2012 was RMB526.5 million (US$83.8 million), compared to RMB501.0 million for the same period in 2011, representing an increase of 5.1%. For the first nine months of 2012, total revenue wasRMB1,542.8 million (US$245.5 million), representing an increase of 0.9% from RMB1,529.5 million for the same period in 2011.
• Basic and diluted earnings per American Depository Share ("ADS") for the third quarter of 2012 were RMB 0.42(US$0.07) and RMB 0.42(US$0.07), respectively. Basic and diluted earnings per ADS for the first nine months of 2012 were RMB1.45 (US$0.23) and RMB 1.44 (US$0.23), respectively. One ADS represents two ordinary shares of the Company.

"In the third quarter of 2012, Simcere's revenue and gross margin fundamentally remained stable," commented Mr.Jinsheng Ren, Chairman of Simcere Pharmaceutical Group. "While sales of edaravone continued to face challenges, we were encouraged to see growth from our generic drugs such as Zailin. I am also pleased that Hongquan Liu, our new Chief Executive Officer, is leading Simcere's management team to improve Simcere's overall operations. I am confident that Simcere will benefit from Hongquan's experience and leadership."

Mr. Hongquan Liu, Executive Director and Chief Executive Officer of Simcere Pharmaceutical Group, commented, "With Simcere's robust product portfolio and leading R&D capabilities, I am confident that Simcere has significant potential for future growth. Moving forward, in order to improve profitability, Simcere's strategic priorities will include focusing on key products, optimizing our sales and marketing organization, strengthening cost control, and in particular reducing sales and marketing expense as a percentage of revenue."

BURLINGAME, Calif., Nov. 11, 2012 /PRNewswire/ -- Apexigen, an emerging biopharmaceutical company dedicated to the discovery and development of best-in-class therapeutic monoclonal antibodies, announced today that its partner, Simcere Pharmaceutical Group (NYSE: SCR) of Nanjing, received approval from the State Food and Drug Administration of China to begin first-in-man trials with APX003, which is also known as BD0801, for the treatment of cancer. With this approval, APX003/BD0801 becomes the first humanized monoclonal antibody derived from Apexigen's proprietary antibody technology platform to enter human trials.

APX003/BD0801 is being developed in China through an active partnership between Apexigen and Simcere.  Apexigen has collaborated with Simcere to add its antibody development expertise and experience to the advancement of the APX003/BD0801 program. This approval marks the success of the dedicated work of the collaboration team to file and defend an IND application, and initiates the next phase of collaboration in clinical development.

"We're very pleased to see the IND approval for APX003/BD0801.  This is an important milestone for our collaboration with Simcere and for proof-of-concept of our antibody technology platform" said Dr. Xiaodong Yang, President & CEO.  "We look forward to continuing the collaboration with Simcere and advancing AXP003/BD0801 into clinical development."

APX003/BD0801 is a humanized monoclonal antibody directed against VEGF and is under development for the treatment of multiple malignancies.

Second Quarter 2012 Results

• Total revenue was RMB528.7 million (US$83.2 million) for the second quarter of 2012, compared to RMB546.4 million for the same period in 2011, representing a decrease of 3.2%. For the first six months of 2012, total revenue was RMB1,016.3 million (US$160.0 million), representing a decrease of 1.2% from RMB1,028.6 million for the same period in 2011.
• Gross margin for the second quarter of 2012 was 83.9%, compared to 84.9% for the same period in 2011. For the first six months of 2012, gross margin was 83.0%, compared to 84.4% for the first six months of 2011.
• Income from operations was RMB41.6 million (US$6.5 million) for the second quarter of 2012, compared to RMB79.9 million for the same period in 2011, representing a decrease of 48.0%. For the first six months of 2012, income from operations was RMB84.8 million (US$13.4 million), which represented a decrease of 22.6% from RMB109.6 million for the same period in 2011.
• Net income attributable to Simcere was RMB27.0 million (US$4.2 million) for the second quarter of 2012, a decrease of 63.4% from RMB73.7 million for the same period in 2011. For the first six months of 2012, net income attributable to Simcere was RMB55.6 million (US$8.8 million), which represented a decrease of 45.3% from RMB101.6 million for the same period in 2011.

Mr. Jinsheng Ren, Chairman and Chief Executive Officer of Simcere Pharmaceutical Group said, "In the second quarter of 2012, Simcere's revenue and gross margin remained largely stable. While sales of edaravone, Endu and Sinofuan continued to grow compared with the first quarter of 2012, year-over-year sales performance was below our expectation. During the quarter, we increased our marketing efforts for branded generic drugs such as Zailin, Yingtaiqing and Biqi which helped drive sales growth in these key products but impacted profitability."

"In the second quarter, we were encouraged by sales of our new Category 1 drug Iremod and Shanghai Celgen's biogeneric drug Qiangke," continued Mr. Ren. "We also received approval to initiate clinical studies for our oncology drug candidate Thiophenib and continue to see strong progress with the four additional new drug candidates currently under clinical trials."

First Quarter 2012 Highlights

Total revenue was RMB487.6 million(US$77.4 million) for the first quarter of 2012, which represented an increase of 1.1% fromRMB482.2 million for the same period in 2011.

• Income from operations was RMB43.3 million (US$6.9 million) for the first quarter of 2012, which represented an increase of 46.1% from RMB29.6 million for the same period in 2011.
• Net income attributable to Simcere was RMB28.6 million (US$4.5 million) for the first quarter of 2012, which represented an increase of 2.6% from RMB27.9 million for the same period in 2011.
• Gross margin for the first quarter of 2012 was 82.0%, compared to 83.9% for the same period in 2011.

"In the first quarter of 2012, sales of Simcere's major products were largely in line with the trend of the last two quarters of 2011," said Mr. Jinsheng Ren, Chairman and Chief Executive Officer of Simcere Pharmaceutical Group. "While our branded generic drugs including edaravone, Zailin and Yingtaiqing faced challenges from the changing regulatory environment and pricing policies, we continue to be encouraged by the performance of our portfolio of oncology drugs including Endu, Sinofuan and Jiebaishu and our antibiotic drug Anxin. Also, Iremod, our new DMARD which was launched in January 2012, has seen a strong market reception with formulary listing in around 100 hospitals."

Unaudited Financial results Fourth Quarter Highlights

• Total revenue was RMB511.0 million (US$81.2 million) for the fourth quarter of 2011, compared toRMB587.7 million for the same period in 2010. For the full year of 2011, total revenue was RMB2,040.5 million (US$324.2 million), which represented a decrease of 4.7% from RMB2,141.1 million in 2010.
• Income from operations was RMB1.6 million (US$0.3 million) for the fourth quarter of 2011, compared toRMB62.8 million for the same period in 2010. For the full year of 2011, income from operations wasRMB143.5 million (US$22.8 million), which represented a decrease of 34.1% from RMB217.9 million in 2010.
• Net income attributable to Simcere was RMB42.8 million (US$6.8 million) for the fourth quarter of 2011, compared to RMB58.7 million for the same period in 2010. For the full year of 2011, net income wasRMB178.4 million (US$28.3 million), which represented an increase of 3.5% from RMB172.4 million in 2010.
• Gross margin for the fourth quarter of 2011 was 82.3%, compared to 84.1% for the same period in 2010. For the full year of 2011, gross margin was 83.9%, a decrease from 84.0% in 2010.

"2011 was a challenging year for Simcere," commented Mr. Jinsheng Ren, Chairman and Chief Executive Officer of Simcere Pharmaceutical Group. "Factors including changes in certain provincial tendering processes as well as government pricing policies negatively impacted full year sales of Zailin and our edaravone products. We were encouraged, however, by the solid full year performance of our oncology drugs Endu, Sinofuan and Jiebaishu, as well as the strong sales growth of our new antibiotic drug Anxin."

Mr. Ren added, "Looking forward, we plan to allocate more sales resources to oncology drugs and new products. We are pleased that we began to sell Iremod, our new Category I Disease Modifying Anti-rheumatic Drug, in the first quarter of 2012. We believe that both Iremod and Qiangke, Shanghai Celgen's Recombinant Human TNF Receptor-IgG Fusion Protein for Injection, have exciting market potential in China."

Simcere holds a 35% equity interest in Shanghai Celgen Bio-Pharmaceutical Co., Ltd.

Compound Edaravone Injection, a new drug being developed by Simcere, received clinical studies approval inFebruary 2012 from the State Food and Drug Administration. Simcere expects to begin Phase I clinical trials of Compound Edaravone Injection in China during the first quarter of 2012. Simcere previously completed Phase I clinical trials of Compound Edaravone Injection in Australia.

Third Quarter 2011 Results

• Total revenue was RMB501.0 million (US$78.5 million) for the third quarter of 2011, representing a decrease of 8.9% from RMB550.1 million for the same period in 2010. For the first nine months of 2011, total revenue was RMB1,529.5 million (US$239.8 million), representing a decrease of 1.5% from RMB1,553.4 million for the same period in 2010.
• Net income was RMB34.0 million (US$5.3 million) for the third quarter of 2011, representing a decrease of 37.8% from RMB54.7 million for the same period in 2010. For the first nine months of 2011, net income attributable to Simcere was RMB135.6 million (US$21.3 million), representing an increase of 19.2% from RMB113.7 million for the same period in 2010.
• EPS for the third quarter of 2011 were RMB0.64 (US$0.10) and RMB0.61 (US$0.10), respectively. Basic and diluted earnings per ADS for the first nine months of 2011 were RMB2.54 (US$0.40) and RMB2.45 (US$0.38) respectively.

NANJING, China, June 7, 2011 /PRNewswire-Asia/ -- Simcere Pharmaceutical Group, a leading pharmaceutical company specializing in the development, manufacturing, and marketing of branded and proprietary pharmaceuticals in China, today announced that a settlement agreement with certain former shareholders and directors of Jiangsu Quanyi Biological Technology Stock Co., Ltd. (previously known as Jiangsu Yanshen Biological Technology Stock Co., Ltd) has become effective. The settlement concerns the ongoing arbitration and litigation between Simcere and said former shareholders and directors they appointed. These shareholders include Mengyuan Investment Co., Ltd. According to the agreement, these former shareholders and directors have agreed to return a total of RMB 50 million in share transfer payments to Simcere.

In May 2009, Simcere signed a share transfer agreement with certain former shareholders of Jiangsu Quanyi to buy 37.5% of the shares in Jiangsu Quanyi for a total consideration of RMB 195.54 million. Following quality control issues relating to the production of Jiangsu Quanyi's human use rabies vaccine discovered in December 2009, Simcere started arbitration and litigation procedure against aforesaid former shareholders and directors of Jiangsu Quanyi.

In 2008, 2009 and 2010, our capital expenditures totaled RMB136.8 million, RMB141.3 million and RMB188.8 million ($28.6 million), respectively. In past years, our capital expenditures consisted primarily of the costs of obtaining land use rights and the purchases of property, plant and equipment and our research and development facilities. We estimate that our capital expenditures in 2011 will be approximately RMB197.9 million ($30.0 million), which we will use mainly for the research and development equipment purchase and facility expansion in Jiangsu Province and Shanghai, the construction of an office building in Shanghai. We expect to use cash generated by operating activities and our cash in hand to pay for our capital expenditures in 2011.

We expect cash provided from operating activities to continue to be a major source of liquidity for us and the future.

First Quarter Results:

• Total revenue was RMB482.2 million (US$73.6 million) for the first quarter of 2011, which represented an increase of 5.1% from RMB458.7 million for the same period in 2010.
• Income from operations was RMB29.6 million (US$4.5 million) for the first quarter of 2011, compared to RMB30.9 million for the same period in 2010.
• Net income attributable to Simcere was RMB27.9 million (US$4.3 million) for the first quarter of 2011, which represented an increase of 36.2% from RMB20.5 million for the same period in 2010

Mr. Jinsheng Ren, Chairman and Chief Executive Officer of Simcere Pharmaceutical Group commented, "In the first quarter of 2011, Simcere maintained strong gross margins, while realizing healthy growth in both revenue and net income attributable to Simcere. As a result of the progress of our sales team reorganization, we saw an encouraging upward trend in sales of our anti-tumor drugs, including Endu, Sinofuan and Jiebaishu."

Basic and diluted earnings per American Depository Share ("ADS") for the first quarter of 2011 were RMB0.52 (US$0.08) and RMB0.50 (US$0.08) respectively

• Total revenue was RMB550.1 million (US$82.2 million) for the third quarter of 2010, an increase of 24.0% from RMB443.7 millionfor the same period in 2009.

• Gross margin for the third quarter of 2010 was 84.8%, compared to 82.2% for the same period in 2009.

• Income from operations was RMB61.6 million (US$9.2 million) for the third quarter of 2010, an increase of 111.9% from RMB29.0 millionfor the same period in 2009.

• Net income attributable to Simcere wasRMB54.7 million (US$8.2 million) for the third quarter of 2010, an increase of 232.7% from RMB16.4 millionfor the same period in 2009.

• Basic and diluted earnings per American Depository Share ("ADS") for the third quarter of 2010 were RMB1.02(US$0.15) and RMB0.99(US$0.15) respectively.

Mr. Jinsheng Ren, Chairman and Chief Executive Officer of Simcere Pharmaceutical Group, commented, "Simcere achieved solid revenue and net profit growth this quarter, both reaching record highs for the past eight quarters. Endu sales also saw sustained recovery as our sales force restructuring continues to pay off."

"We are very proud of our recent progress in establishing R&D partnerships," Mr. Ren continued.  "Simcere's agreement with Bristol-Myers Squibb is a milestone cooperative effort between a Chinese pharmaceutical leader and an international biopharma company to create a more effective model for the development of innovative drugs."  

Guidance Report:

Rob Ruhlman, Chairman and Chief Executive Officer, said, "I am pleased with the achievement of sales growth for the fifth consecutive year including three straight years of record sales. Net income has improved for three consecutive years and our 2008 net income is second only to the dot com boom year of 1998. These improvements resulted from product innovation, improvements in production efficiencies, customer focus and strategy integration implemented over the past several years. We have a strong balance sheet and are positioned to succeed in these uncertain economic times. I cannot predict what 2009 will bring, but I am confident we are prepared for the challenges that lie ahead."

Source: PR Newswire (March 12, 2009)