ASTRAZENECA PHARMA IND LT

AstraZeneca Pharma India Limited (APIL) was incorporated on July 11, 1979. The Company is engaged in the business of manufacture, distribution and marketing of pharmaceutical products and co-ordinates clinical trial services with an overseas group company. The major therapy areas where the company operates are Onocology, Alimentary & Metabolism, Cardio Vascular, Renal, Diabetes, Respiratory and Oncology. AstraZeneca Pharma India, formerly known as Astra-IDL (AIL), was an erstwhile joint venture of Astra Zeneca, UK and Hinduja controlled IDL. Astra Pharmaceuticals AB, Sweden acquired all of the 1287500 equity shares in the Company of IDL, representing 25.75% of the Company's issued and paid up equity share capital. Consequently, the Company became a subsidiary of Astra, which is a direct wholly owned subsidiary of Astra AB, Sweden (now known as AstraZeneca Pharmaceuticals AB Sweden) and an indirect wholly owned subsidiary of AstraZeneca Plc, the Group parent Company. AstraZeneca Pharmaceuticals AB Sweden. AstraZeneca Pharma India Limited (the Company') is a subsidiary of AstraZeneca Pharmaceuticals AB, Sweden, which is an indirect subsidiary of AstraZeneca PLC, United Kingdom. The company expanded the installed capacity of Injectables during the year 2001 by 0.20 crores (Nos) and with this expansion the total capacity has been increased to 2.40 crores (Nos). The Company's marketing activities including medical services have been certified for ISO 9002. During 2001-02 the company has commissioned the automatic ampoule filling machine and thereby increased the capacity of the same from 10 Mio to 12 Mio. The company has launched during the year 2003, an Oncology product, Arimidex, for the management of breast cancer. The Pharmaceutical major Astrazeneca has decided to make its Astrazeneca India's R&D as a part of its global R&D organisation. The company has decided to expand its process R&D group in Bangalore. It has purchased 14200 Sq Mtr of land, which is a part of its 'Avishkar' campus, where it has set up R&D centre. The Year 2013-14 was the first full year post supply stabilization from AstraZeneca Pharma India's (APIL) factory operations, which had impacted the performance of the company since March 2012. The Year 2013-14 witnessed a series of regulatory interventions in the Indian Pharmaceutical Market. The National Pharmaceutical Pricing Policy 2012 announced by the Government in December 2012 had brought 348 medicines covered in the National List of Essential Medicines (NLEM), under price control. Based on this policy, Drug Pricing Control Order was notified in May 2013. Since then, ceiling prices have been announced by the Government in a phased manner. 15 SKUs across 8 brands of the company were covered under the NLEM. The company implemented the notifications for ceiling prices for 15 SKUs across 8 brands marketed by the company and listed on the NLEM. The range of patient price reduction on the affected SKUs was 4%-52% (average price reduction ~30%). During the year under review, the company's drug brand Brilinta (Ticagrelor) which provides cardiologists with a new and effective treatment to help reduce the rate of heart attack and cardiovascular deaths in adult patients with Acute Coronary Syndrome (ACS), continued to grow its market share, as per IMS Health, from 1.4% (MAT March 2013) to 6.7% (MAT March 2014). The company's manufacturing site at Yelahanka resolved many constraints in the supply during the year 2013-14, consistently meeting supply requirements. The planned move of manufacture and Quality Control (QC) laboratory from its existing facilities to the new state-of-the-art tablets and laboratory facility was completed as per the plan with the first commercial supply from the new facility taking place in the first quarter of Financial Year 2013-14. The establishment programme was delivered to plan, with planned QC transfers and the majority of tablet transfers delivered by the end of the Financial Year 2013-14. This will enable the cessation of manufacture from the existing manufacturing facility and will ensure a platform for consistent supply of global quality medicines. The supply assurance of Terbutalane Sulphate (TBS) API to AstraZeneca Group was strengthened with an INR 185.5 million investment. The upgrade programme was completed in the last quarter of Financial Year 2013-14. In order to assist the company in its efforts to establish/grow its presence in the Indian market despite the significant losses incurred, AstraZeneca Pharmaceuticals AB Sweden (Promoter Company) agreed to provide a voluntary non-repayable financial grant of approximately USD 22.5 million to USD 26.5 million over the three years period Financial Year 2013-14 to Financial Year 2015-16 under a Subvention Agreement dated 7 May 2013. During the year ended 31 March 2014, APIL received a sum of Rs. 862.4 million as financial grant under the said agreement. The Promoter Company vide its letter dated 1 March 2014 informed the Board of Directors of APIL of a revision of the said agreement, whereby the payment under the said agreement was revised to USD 14 million (Indian rupee equivalent 862.4 million) and period covered under the said agreement to financial year 2013-14. The Promoter Company, in terms of the said agreement, vide its letter dated 25 April 2014 terminated it effective 25 March 2014 on the ground that APIL's business and financial performance has been in line with more recent expectations and that APIL shall not require any further grant for the financial years 2014-15 and 2015-16. In the last Directors' Report, shareholders were informed of the ongoing investigation pursuant to a First Information Report filed in February 2012 by the Central Bureau of Investigation against, among others, the company. The investigation was concluded and a charge sheet was filed in the Court by CBI on 5 August 2013. Neither the company nor any of its officials/employees have been named as accused in the charge sheet. In December 2013, AstraZeneca globally announced an agreement to purchase Bristol Myers-Squibb' (BMS) 50% interest in AstraZeneca's and BMS's joint diabetes business. On 1 February 2014, AstraZeneca completed the acquisition of BMS's interests in the companies' diabetes alliance. APIL had since 2010 been associated with BMS in promotions of Onglyza (Saxagliptin), Kombiglyze XR (Saxagliptin and Metformin HCl extended release) and Byetta in the Indian Pharmaceutical Market. AstraZeneca's acquisition of BMS at the global level enables APIL to focus on the Diabetes segment, which today impacts approximately 65 million people in India, who are suffering from the disease. In FY 2014-15, AstraZeneca Pharma India's (APIL) key growth brands - Brilinta, Onglyza, Kombiglyze, witnessed robust growth, providing strong momentum to the company's performance throughout the year. Diabetes portfolio of the company grew by 33% post acquisition from Bristol Myers-Squibb (BMS). During the year under review, the company's drug brand Brilinta (Ticagrelor) which provides cardiologists with a new and effective treatment to help reduce the rate of heart attack and cardiovascular deaths in adult patients with Acute Coronary Syndrome (ACS), continued to grow its market share, as per IMS Health, from 6.7% (MAT March 2014) to 9.7% (MAT March 2015). In the year 2014-15, 10 selling units across 5 brands of the company were additionally covered under the National List of Essential Medicines (NLEM). While the said Order benefits the patients by making essential drugs affordable, it had an adverse impact on the company's profitability due to average price reduction of 41%. The company, during the year under review, undertook a comprehensive review of the manufacturing standards of its contract manufacturers and identified certain process weaknesses. Production was stopped pending the review. Due to this, a significant part of the company's portfolio, including several of its major brands, namely, Bricanyl (Respiratory), Bricarex (Respiratory), Linctus Codeinae (Respiratory), Xylocaine (Local Anesthesia), Sensorcaine (Local Anesthesia), Cerviprime (Maternal), Prostodin (Maternal), Seloram and Selomax (Cardiovascular) were not available in the market during a substantial part of the year. During the year under, the company's manufacturing site at Yelahanka resolved many constraints in the supply, consistently meeting supply requirements. The entire manufacturing of Oral Solid Dosages was shifted to the New Tablet Manufacturing Plant on 1 July 2014 and the Old Pharma Plant was shut down in December 2014. The current oral solid dosage facility has spare manufacturing capacity. Different options are under consideration to utilize this capacity to put the company on a stronger footing for the future. In 2015-16, AstraZeneca Pharma India's (APIL) key growth brands - Brilinta, Forxiga, Onglyza, Kombiglyze and Symbicort, witnessed robust growth of 76% over last year, providing strong momentum to the company's performance throughout the year. Diabetes portfolio of the company grew by 74% post acquisition from Bristol Myers-Squibb and launch of Forxiga. Forxiga is part of a newer class of medicines known as SGLT2 (Sodium Glucose Cotransporter 2) inhibitors that act to block reabsorption of sugar in the kidneys. During the year under review, the company's drug brand Brilinta (Ticagrelor) continued to grow its market share, as per IMS Health, from 9.43% (MAT March 2015) to 14.3% (MAT March 2016) and continued to be the No1 Oral Antiplatelet brand. In 2015-16, Meronem became the company's first brand to cross the Rs. 100 crore sales milestone. During the year under review, APIL entered into three Distribution Services Agreements. With Dr. Reddy's Laboratories for Saxagliptin and its fixed dose combination with metformin, APIL's patented therapy for the treatment of type 2 Diabetes. The second Distribution Services Agreement is with Sun Pharma for Ticagrelor for treatment of acute coronary syndrome (ACS) and the third Distribution Services Agreement for the treatment of type 2 Diabetes with Sun Pharma to promote and distribute Dapagliflozin and its fixed dose combination with metformin. Pursuant to the above agreements, APIL, Dr. Reddy's Laboratories and Sun Pharma will co-promote, market & distribute Saxagliptin, Dapagliflozin and Ticagrelor under different brand name in Indian market. These partnerships are in line with APIL's commitment to transform patient care in Diabetes and ACS. It will enable the company to increase the share of voice for the molecules through a wider reach to physicians, thereby benefitting more number of patients. In view of low demand for Terbutaline Sulphate (TBS), which was manufactured predominantly for export markets and TBS being the only Active Pharmaceutical Ingredient (API) which was manufactured at APIL's factory in Bangalore and no other API manufacturing activity was planned to be carried out in the future, the Board of Directors of the company decided to close the Active Pharmaceuticals Ingredient Unit (API Unit) situated at Yelahanka, Bangalore. An appeal was filed by two shareholders of the company (Appellants) before the Securities Appellate Tribunal (SAT), against part of the Order of Securities and Exchange Board of India (SEBI) dated 24 June 2014, in relation to delisting proposal of AstraZeneca Pharmaceuticals AB, Sweden (AZPAB). The SAT heard the appeal on 11 September 2015 and disposed off the same. SAT accepted the statement made by the Counsel for APIL and AZPAB that they shall not proceed with the delisting of equity shares of API till completion of investigation and passing of order by SEBI on merits. SEBI shall complete the investigation within a period of six months from 11 September 2015 and pass appropriate order on merits after hearing the parties including the Appellants, as expeditiously as possible. If the order to be passed by SEBI on merits is adverse to the Appellants, then the said order shall not be given effect to from the date of passing the said order till it is communicated to the Appellants and four weeks thereafter. During the financial year ended 31 March 2017, AstraZeneca Pharma India (APIL) aligned its portfolio to AstraZeneca's Global therapeutic focus which is in core areas of Cardio-Metabolism, Oncology and Respiratory. Accordingly, certain brands were divested globally and locally in therapy areas of Antibiotics, Local Anaesthesia, Maternal Health Care and other Products. This resulted in de-growth in APIL's financial year 2016-17 sales; however, the underlying growth of the company for 2016-17 for non-divested brands was at 15.8%. APIL's partnerships with Dr. Reddy's Laboratories to distribute Saxagliptin and with Sun Pharma to distribute Dapaglifiozin and Ticagrelor under different brand names enabled APIL to increase access to a wider reach of health care professionals thereby benefitting more patients. AstraZeneca Pharma India launched Xigduo, a fixed dose combination drug, to improve glycemic control in adults with type 2 diabetes mellitus, when treatment with both dapagliflozin and metformin is appropriate in the last quarter of 2017-18. Imfinzi (Durvalumab) was launched in October 2019. In Oct' 2019, the Company launched Lynparza. In year 2020-21, Lynparza, which was launched in combination with bevacizumab got an additional approval for the first line treatment of Ovarian Cancer and also for treatment of metastatic castrate resistant prostate cancer harboring HRR mutations. It launched a new product Calquence (Acalabrutinib) in the Hematology segment as well. In 2022, the Company introduced Benralizumab (Fasenra) which is an innovative therapy to treat Severe Uncontrolled Asthma. During the year 2022, two new global clinical studies (HIMALAYA and TOPAZ-1) were read out. Positive results from Himalaya Phase III trial showed a single, high priming dose of Tremelimumab added to Imfinzi demonstrated improved overall survival (OS) versus sorafenib in 1st-line unresectable hepatocellular carcinoma (HCC). Positive results from TOPAZ-1 Phase III trial showed Imfinzi plus Chemotherapy improved OS versus Chemotherapy alone in 1st - Line advanced bilary tract cancer. In 2022-23, Fasenra the first Biologic from AstraZeneca to treat Severe Eosinophilic Asthma (SEA) has touched more than 400 Patients. Fasenra has gained significant traction amongst Pulmonologists. In 2023-24, a key catalyst for growth in breast cancer was the launch of Transtuzumab Deruxtecan (Enhertu) for HER-2 positive metastatic breast cancer in January 2024. In March 2024, Enhertu also received another key indication approval in Breast Cancer for treatment of adult patients with unresectable or metastatic HER-2 low breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy. The Company launched Selumetinib (Koselugo), the first and only approved therapy for the treatment of paediatric patients with neurofibromatosis type 1 (NF1) who have inoperable plexiform neurofibromas (PN). In March 2024, it launched several generic versions of Olaparib and consequent expected erosion in the market share for Lynparza. Fasenra the first Biologic from AstraZeneca to treat Severe Eosinophilic Asthma (SEA) has touched more than 600 Patients in 2024.