Infliximab biosimilar (EPIRUS Biopharma)

PDF (455KB)PDF For Immediate Release Company name: DAIICHI SANKYO COMPANY, LIMITED Representative: Joji Nakayama, Representative Director, President and CEO (Code no.: 4568, First Section, Tokyo Stock Exchange) Please address inquiries to Noriaki Ishida, Corporate Officer, Vice President, Corporate Communications Department Telephone: +81-3-6225-1126 http://www.daiichisankyo.com/ Gurgaon, India, January 28, 2015: The Board of Directors of Ranbaxy Laboratories Limited (RLL, NSE: RANBAXY, BSE: 500359), at their meeting held today, took on record the unaudited results for the Quarter and 9 months ended December 31, 2014 (“Q3 FY15” and “YTD Dec’14” respectively) under Indian GAAP. Key Financial Highlights Consolidated Financial Performance for the quarter ended December 31, 2014 (Q3 FY15) ・ Sales were Rs.25,876 Mn [Oct’13-Dec’13: Sales Rs.28,590 Mn]. ・ Earnings before Interest, Tax, Depreciation & Amortization (EBITDA) was Rs.1,129 Mn. ・ Loss before tax was Rs.1,354 Mn ・ Net loss after tax, minority interest and share in loss of associates was Rs.10,297 Mn. During the current quarter, the company has reviewed the carrying amount of an asset representing Minimum Alternate Tax (MAT) Credit of Rs.8,227 Mn and has decided to provide for the same on grounds of conservatism. Consolidated Financial Performance for YTD ended December 31, 2014 (YTD Dec’14) ・ Sales were Rs.81,778 Mn [Oct’13-Dec’13: Sales Rs.81,931 Mn]. ・ Earnings before Interest, Tax, Depreciation & Amortization (EBITDA) was Rs.11,579 Mn. Commenting on the business results for the quarter, Arun Sawhney, CEO & Managing Director, Ranbaxy, said, “Ranbaxy recorded good growth in India, Russia, APAC & LATAM during the quarter. However, overall sales were impacted by global currency depreciation in some markets. During the quarter, we introduced India’s First New Chemical Entity (NCE), SynriamTM in Africa which is a new and convenient therapy option for patients suffering from malaria.” Commenting on the merger with Sun Pharma, Mr. Sawhney said, “The merger process is progressing well and we are working towards the completion of the pre-requisites.” Key Highlights/ Developments Business ・ The India region business recorded 12% growth in line with the Indian Pharma Market (IPM) growth. ・ Ranbaxy’s market share for Absorica™, Isotretinoin NDA in the USA was 19.2%. (End of Nov’14: Source IMS) ・ Ranbaxy wins ‘Pay for Delay’ case: A jury in United States District Court for the District of Massachusetts issued a verdict in the esomeprazole antitrust litigation in favour of the company. Regulatory, Research & Development and Manufacturing ・ Ranbaxy launched India’s first Biosimilar of Infliximab, InfimabTm through a licensing partnership with EPIRUS Biopharmaceuticals, Inc. It is indicated for the treatment of inflammatory diseases including rheumatoid arthritis, Crohn’s Disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis and psoriasis. ・ Ranbaxy received the regulatory approval to launch India’s first NCE (New Chemical Entity), Synriam™ in 7 African countries viz. Nigeria, Uganda, Senegal, Cameroon, Guinea, Kenya and Ivory Coast. The product has since been launched in Uganda and will be made available in other countries towards end of Jan’15. ・ Ranbaxy received approval from US FDA to market Fenofibrate Capsules. It is indicated for Primary Hypercholesterolemia, Mixed Dyslipidemia and Severe Hypertriglyceridemia. ・ On 26th Jan 2015, Ranbaxy received a communication from USFDA that they have determined that Ranbaxy has forfeited its 180 day exclusivity for esomeprazole magnesium delayed release capsule 20 mg and 40 mg. Ranbaxy is disappointed with the result and is pursuing all available legal options to preserve its rights. Ranbaxy and Sun Pharma Merger ・ On 5th Dec 2014, Competition Commission of India conditionally approved the merger between Ranbaxy and Sun Pharmaceutical Industries limited. A total of 7 products, 6 of Ranbaxy & 1 of Sun, are mandated to be divested as a pre-condition to the clearance of the merger. ・ Approval from FIPB was received on 15th Dec 2014. ・ US FTC: Approval is awaited. ・ The next date of hearing of High Court of Punjab and Haryana is 2nd Feb 2015. Global Sales Consolidated sales for the Quarter were Rs.25,876 Mn as compared to Rs.28,590 Mn in the corresponding quarter. 　－Branded and OTC category contributed Rs.14,202 Mn accounting for 57% of total sales during the Quarter. Generics (incl. FTF) & others category recorded Rs.11,674 Mn of sales for the Company during the Quarter. ・ North America: Sales for the Quarter were Rs.8,963 Mn. 　－In the USA, sales for the Quarter were Rs. 8,214 Mn. ・ India (including OTC): In the domestic market, sales for the Quarter were Rs.5,909 Mn, a growth of 2% over the corresponding quarter. India region witnessed growth of its prime segments within the Branded Business. ・ East Europe & CIS: The region recorded sales of Rs.3,725 Mn. Currency depreciation in Russia and Ukraine impacted sales in the region. ・ West Europe: Sales for the Quarter were Rs.2,080 Mn. Sales were driven by strong performance in UK, Germany, Spain and North Europe. ・ Africa and Middle East: Sales for the Quarter were Rs.2,241 Mn. ・ Asia Pacific and LATAM (including Sri Lanka):Sales for the Quarter were Rs.2,183 Mn, a growth of 46%* over the corresponding period. Sales were higher largely due to performance in Australia, Malaysia, Thailand and Brazil. ・ API business and others generated revenues of Rs.711 Mn and were primarily impacted by supply issues at Toansa and Dewas. Ranbaxy Laboratories Limited, India’s largest pharmaceutical company, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy’s continued focus on R&D has resulted in several approvals, in developed and emerging markets many of which incorporate proprietary Novel Drug Delivery Systems (NDDS) and technologies, developed at its own labs. The company has further strengthened its focus on generics research and is increasingly working on more complex and specialty areas. Ranbaxy serves its customers in over 150 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 43 countries and manufacturing operations in 8 countries. Ranbaxy is a member of the Daiichi Sankyo Group. Through strategic in-licensing opportunities and its hybrid business model with Daiichi Sankyo, a leading global pharma innovator headquartered in Tokyo, Japan, Ranbaxy is introducing many innovator products in markets around the world, where it has a strong presence. This is in line with the company’s commitment to increase penetration and improve access to medicines, across the globe. For more information, please visit www.ranbaxy.comOpen new window. *Growth % is calculated at constant forex over Q3 FY 2014 For more information please contact: Koji Ogawa Head - Corporate Services email: koji.ogawa@ranbaxy.com Tel: +91-124-4135620 Krishnan Ramalingam General Manager, Corporate Communications email: krishnan.ramalingam@ranbaxy.com Mobile: 9810042540 Gaurav Chugh Senior Manager - Corporate Communications Email: gaurav.chugh@ranbaxy.com Mobile: 9810471414

PDF (110KB)PDF For Immediate Release Company name: DAIICHI SANKYO COMPANY, LIMITED Representative: Joji Nakayama, President and CEO (Code no.: 4568, First Section of Tokyo Stock Exchange) Please address inquiries to Noriaki Ishida, Corporate Officer, Vice President, Corporate Communications Department Telephone: +81-3-6225-1126 http://www.daiichisankyo.com Base business grows by 10%+ QoQ and on YTD basis; Robust growth in EBITDA during the quarter and on YTD basis Gurgaon, India/Tokyo, Japan, February 05, 2014: The Board of Directors of Ranbaxy Laboratories Limited (RLL, NSE: RANBAXY, BSE: 500359), at its meeting held today, took on record the unaudited results for the Quarter and YTD ended December 31, 2013 (“Q4 FY14” and “YTD Dec’13” respectively) under Indian GAAP. Key Financial Highlights Financial Performance for the quarter ended December 31, 2013 (Q4 FY14) * Consolidated Sales were Rs.28.6 Bn [Q4’12: Sales Rs.26.7 Bn]. * Earnings before Interest, Tax, Depreciation & Amortization (EBITDA) was Rs.2.7 Bn. Margins strengthened in the quarter. Adjusted for Forex movements and non-routine charges, margin was >10% The Company recorded a net loss before taxes of Rs.0.6 Bn after providing for stock write-off and other costs of Rs.2.6 Bn pursuant to the inclusion of the Toansa plant under certain provisions of the Consent Decree (CD) by USFDA. (Please refer to the section “Regulatory, Research & Development and Manufacturing” for further details) Financial Performance for YTD ended December 31, 2013 (YTD Dec’13) * Consolidated sales were Rs.106.0 Bn [YTD Dec’12: Sales Rs.122.5 Bn]. Base business sales growth was led by India, East Europe & CIS and USA * Earnings before Interest, Tax, Depreciation & Amortization (EBITDA) was Rs.8.2 Bn. Base business margins improved over the corresponding period. Adjusted for Forex movements and non-routine charges, margin was > 10% Commenting on the business results for the quarter, Mr. Arun Sawhney, CEO & Managing Director, Ranbaxy, said, “Ranbaxy has been strengthening its base business in key markets including India, Eastern Europe & CIS and the USA which has helped us recover our margins. We are facing some major regulatory challenges and are disappointed with the developments. I would like to assure all our stakeholders that we will do whatever is necessary to address all concerns of the USFDA and are committed to resolve them as early as possible.” Key Highlights/ Developments Business *Base business sales in Q4 FY14 continued to grow over the corresponding period - Sales grew in the major markets of USA, India and East Europe *Ranbaxy maintains strong market share in Absorica™, isotretenoin NDA in the USA. As of December 27, 2013 Ranbaxy’s market share was at 17.2%. The Company had earlier in Sep 2013 received a Paragraph IV Certification Notice of filing from Watson Laboratories of an ANDA to the USFDA for a generic version of Absorica™ Regulatory, Research & Development and Manufacturing *The Toansa facility was issued a Form 483 containing certain observations in Jan 2014 and was subsequently included under certain provisions of the Consent Decree (CD) by USFDA. Subsequent to issuance of Form 483, the Company had voluntarily and proactively suspended shipments of API to the USA market from the facility out of abundant caution. Impact of the above-mentioned development was Rs.2.6 Bn on account of stock write-offs and other related costs that have been included below the EBITDA *Remediation plan for Dewas and Paonta Sahib progresses in line with the Consent Decree *Mohali plant was placed under the cGMP provisions of the CD in Sep 2013. All commitments to date have been met and remediation is progressing per plan *Received Central Drugs Standard Control Organisation (CDSCO) approval to manufacture and market Synriam™ in India for the treatment of malaria caused by Plasmodium vivax parasite *Received final approval from the USFDA to manufacture and market Felodipine Extended-Release tablets USP, 2.5 mg, 5 mg and 10 mg. Felodipine is indicated for the treatment of hypertension *Received approval to market Ran™- Donepezil in Canada. Donepezil is indicated in the treatment of dementia in Alzheimer’s patients *The new entity established in Thailand started its operations during the quarter. Earlier in Jan 2013, Ranbaxy and Daiichi Sankyo had announced their intention to integrate their business operations in Thailand, to leverage and maximize the synergies under the Hybrid Business Model *The Company completed 20 years of operations in Ukraine in Nov 2013 *Ranbaxy and EPIRUS announced signing of licensing agreement for BOW015, a biosimilar version of Infliximab used in the treatment of rheumatoid arthritis. The product will be introduced in India and other Emerging Markets. Currently, there is no biosimilar of Infliximab approved in India *During the Quarter, 3 ANDAs were filed for the USA market Global Sales *Consolidated sales for the Quarter were Rs.28.6 Bn as compared to Rs.26.7 Bn, a growth of 7% during the quarter. The details are as follows: - Branded and OTC category contributed Rs.14.8 Bn accounting for 52% of total sales during the Quarter. Generics including API category recorded Rs.13.8 Bn of sales for the Company during the Quarter *North America: Sales for the Quarter were Rs.10.2 Bn - In the USA sales for the Quarter were Rs.9.1 Bn *India: In the domestic market, sales for the Quarter were Rs.5.8 Bn - OTC business (Consumer Healthcare) contributed Rs.1.2 Bn *East Europe & CIS: The region recorded sales of Rs.4.6 Bn *West Europe: Sales for the Quarter were Rs.2.3 Bn *Africa and Middle East: Sales for the Quarter were Rs.2.6 Bn *Asia Pacific and LATAM (including Sri Lanka):Sales for the Quarter were Rs.1.7 Bn *API business and others had revenues of Rs.1.4 Bn Ranbaxy Laboratories Limited is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy’s continued focus on R&D has resulted in several approvals, in developed and emerging markets many of which incorporate proprietary Novel Drug Delivery Systems (NDDS) and technologies, developed at its own labs. The company has further strengthened its focus on generics research and is increasingly working on more complex and specialty areas. Ranbaxy serves its customers in over 150 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 43 countries and manufacturing operations in 8 countries. Ranbaxy is a member of the Daiichi Sankyo Group. Through strategic in-licensing opportunities and its hybrid business model with Daiichi Sankyo, a leading global pharma innovator headquartered in Tokyo, Japan, Ranbaxy is introducing many innovator products in markets around the world, where it has a strong presence. This is in line with the company’s commitment to increase penetration and improve access to medicines, across the globe. For more information, please visit www.ranbaxy.comOpen new window..