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As On 16-Apr-2021 EOD, Market Closed
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Sun Pharmaceutical Industries Limited including its subsidiaries and associates (Sun Pharma) is the fourth largest global specialty generic company that is ranked No. 1 in India and No. 8 in the US. It is the largest Indian pharmaceutical company in the US and among the leading Indian pharmaceutical companies in emerging markets. The company manufactures and markets a large basket of pharmaceutical formulations covering a broad spectrum of chronic and acute therapies. It includes generics, branded generics, complex or difficult to make technology intensive products, over-the-counter (OTC) products, anti-retrovirals (ARVs), Active Pharmaceutical Ingredients (APIs) and intermediates. The product portfolio of over 2000 high quality molecules covers multiple dosage forms, including tablets, capsules, injectables, inhalers, ointments, creams and liquids. The products cater to a vast range of therapeutic segments covering psychiatry, anti-infectives, neurology, cardiology, orthopaedic, diabetology, gastroenterology, ophthalmology, nephrology, urology, dermatology, gynaecology, respiratory, oncology, dental and nutritionals.

The company has global presence with 43 manufacturing facilities across the world. India and the US are two predominant markets, accounting for nearly 70% of the company's revenue. The company has a robust product pipeline and established presence in Europe and high-growth emerging markets like Russia, Romania, South Africa, Brazil and Mexico. The company has entered into a joint-venture agreement with MSD (Merck) to develop and bring differentiated branded generics to emerging markets. Sun Pharmaceutical Industries invests around 7-8% of its global revenue each year in R&D. The R&D capabilities span the development of differentiated products such as liposomal products, inhalers, lyophilized injections and nasal sprays, besides controlled release dosage forms.

Sun Pharmaceutical Industries Ltd was incorporated in the year 1983. The company began operations in Kolkata with just 5 products to treat psychiatry ailments. They set up a compact manufacturing facility for tablets/capsules at Vapi. Sales were initially limited to two states in Eastern India. In the year 1986, the company set up an administrative office in Mumbai. They extended the customer coverage to select cities in Western India. In the year 1987, they rolled out their marketing operations nation-wide.

In the year 1988, the company launched Monotrate and Angizem products. In the year 1989, they introduced Products used in gastroenterology. They moved their corporate office to Baroda. Also, they began exporting their products to neighboring countries. In the year 1998, the company established their first research center, SPARC and this created the base for strong product and process development that enabled growth in the subsequent years. Also, they began office in Moscow.

In the year 1994, the company was listed on the main stock exchanges in India. They started production in a dosage form plant at Silvassa. Also, they completed the major expansion at Vapi plant. In the year 1995, the company's first API plant at Panoli started production. Also, a new division, Azura, was begun for cardiology products. Inca, a new division to market critical care medication to intensive care units began operations. They strengthened the international marketing with offices in Ukraine and Belarus.

In the year 1996, the company acquired an API plant at Ahmednagar from the multinational Knoll Pharmaceutical, and expanded and substantially upgraded for regulated markets, with capacity addition over the years across differentiated API lines such as anticancers and peptides. Also, the company acquired equity stake in Gujarat Lyka Organics Ltd., a manufacturer of Cephalexin Active with a USFDA approval for the intermediate, 7ADCA.

In the year 1997, the company's headquarters was shifted to Mumbai, India's commercial capital. Also, they began the first of their international acquisitions with an initial $7.5 million investment in Caraco, Detroit. Also, they took equity stake in MJ Pharma, a manufacturer of several dosage form lines with UK MHRA approval for Cephalexin capsules. The company acquired TDPL with an extensive product offering and its portfolio streamlined.

In the year 1998, the company acquired a basket of products, including several respiratory/asthma brands acquired from Natco Pharma. Their new formulation plant at Silvassa commenced operations. In the year 2001, the company built a new formulation plant in Dadra. Also, the erstwhile TDPL division was renamed Spectra. A new division, Arian, targeting cardiologists/physicians and diabetologists, was launched.

In the year 2004, the company acquired common stock and options from 2 large shareholders of Caraco, increasing stake to over 60% from 44% at a total outlay of about $42 million. The upgraded and expanded formulation site in Halol, India (the erstwhile MJ Pharma site) received approval from USFDA, UK MHRA, South African MCC, Brazilian ANVISA and Columbian INVIMA.

During the year, the company completed the construction at a formulation manufacturing site at Jammu. They commissioned their first joint venture manufacturing unit, in Dhaka, Bangladesh. Also, two of their API factories received USFDA approval, taking the total number of US FDA approved sites to three. The company acquired a Cephalosporin Active manufacturer, Phlox Pharma, with European approval for cefuroxime axetil amorphous. In December 2004, a research centre spread over 16 acres was inaugurated by the President of India, with special lab space for drug discovery and innovation.

In the year 2005, the company bought a plant in Bryan, Ohio, US and the business of ICN, Hungary from Valeant Pharma. In December 2005, they acquired the intellectual property and assets of Able Labs from the US District Bankruptcy court in New Jersey. In the year 2007, the company de-merged the innovative research and business into a new company, SPARC Ltd. SPARC Ltd was listed on the stock exchanges in India, the first pure research company to be so listed.

In May 2007, the company along with their subsidiaries, signed definitive agreements to acquire Taro Pharmaceutical Industries Ltd., a multinational generic manufacturer with established subsidiaries, manufacturing and products across the US, Israel, Canada for $454 million.

In November 2008, the company along with their subsidiaries acquired 100% ownership of Chattem Chemicals, Inc., a narcotic raw material importer and manufacturer of controlled substances with an approved API facility in Tennessee. This offers vertical integration for its controlled substance dosage form business in the US.

In September 2010, the company acquired Taro Pharmaceuticals. This acquisition doubled the size of their US business and brought them a range of generics including a strong line of dermatologicals.

In April 2011, MSD in India and Sun Pharmaceutical Industries Ltd announced formation of an India-specific strategic partnership agreement under which Sun Pharma will have the right to market, promote and distribute MSD's diabetes products, sitagliptin and sitagliptin plus metformin, under different brand names in India. In June 14, 2011, Caraco Pharmaceutical Laboratories Ltd (Caroco) merged with a subsidiary of the company. Thus, Caraco became a wholly owned subsidiary of the company.

In 2012, Sun Pharma bagged USFDA approval for its AND Application for generic Zyprexa. The company also acquired URL generic business from Takeda during the year under review.

In 2013, the company announced US FDA approval for generic Cymbalta. The company and Intrexon formed Joint Venture to Develop New Class of Therapeutics for Ocular Diseases. The Company announces USFDA approval for generic Prevacid, generic DoxilAr and generic DepoAr-Testosterone Injection. The company also Announces 1:1 Bonus during the year. The company also announces Tentative USFDA approval for generic Januvia & Glumetza.

In 2014, the company announced US FDA approval for generic Temodar. The company acquires Pharmalucence during the year. The company and Merck & Co. Inc. enter into Licensing Agreement for Tildrakizumab during the year under review. The Board of Directors of the Company at its Meeting held on April 06, 2014 has approved the scheme of arrangement between Ranbaxy Laboratories Limited and the Company under the provisions of the sections 391 to 394 and other applicable provisions of the Companies Act, 1956 and corresponding provisions of the Companies Act, 2013 subject to receipt of necessary approvals, consents and filings.

In 2015, the company receives US FTC clearance for Ranbaxy acquisition. The company and AstraZeneca enter into distribution agreement for ticagrelor in India during the year. SPARC Licenses Xelpros (Latanoprost BAK-free) to Sun Pharma. During the year, Hon'ble High Court of Gujarat, at Ahmedabad has approved the Scheme of Amalgamation of Sun Pharma Global Inc. (SPGI), wholly-owned subsidiary of the Company. The company also announces US FDA Approval for Ximino TM. The company also announces another successful completion of Opiates business acquisition in Australia and also acquires InSite Vision Incorporated. The company announces Absorica patent litigation settlement during the year under review.

On 10 December 2015, Sun Pharmaceutical Industries announced that it has entered into a tripartite research and option agreement with Israel-based Weizmann Institute of Science and Spain's Health Research Institute of Santiago de Compostela (IDIS) to develop breakthrough products for the treatment of neurological diseases like brain stroke as well as glioblastoma, a lethal brain cancer.

On 14 December 2015, Sun Pharmaceutical Industries announced that as a part of its manufacturing consolidation in the US, one of its wholly owned subsidiaries has entered into an agreement with Nostrum Laboratories Inc. (Nostrum) for the divestment of the Bryan (Ohio) unit in the US. As a part of the agreement, the Sun Pharma subsidiary has divested this unit as a going concern along with the employees and related products to Nostrum.

On 19 December 2015, Sun Pharmaceutical Industries announced that it has received a Warning Letter from the USFDA as a result of the September 2014 inspection for its facility located at Halol, Gujarat in India. Post the September 2014 inspection, the US FDA has withheld future product approvals from the Halol facility. Sun Pharma said that the company expects to request a re-inspection by USFDA upon completion of its remediation commitments. Sun Pharma also said at that time that the Halol facility will continue to supply important drug products to meet its obligations to its customers and the patients who use the drugs in the United States and around the world.

On 23 March 2016, Sun Pharma and AstraZeneca Pharma India Limited announced a partnership for the distribution of dapagliflozin, an innovative Type 2 diabetes medicine, in India. Dapagliflozin is AstraZeneca India's leading diabetes medicine. Under the agreement, Sun Pharma will promote and distribute dapagliflozin under the brand name Oxra. AstraZeneca India markets dapagliflozin under the brand name Forxiga and under the terms of the agreement, both companies will promote, market and distribute dapagliflozin in India under different brand names. AstraZeneca will retain the intellectual property rights to dapagliflozin. Sun Pharma will also gain the rights to promote and distribute the combination of dapagliflozin with metformin under the brand name Oxramet after requisite regulatory approval.

On 29 March 2016, Sun Pharma announced the acquisition of 14 established prescription brands from Novartis AG and Novartis Pharma AG in Japan. According to the agreements entered into between the parties, a wholly-owned subsidiary of Sun Pharma will acquire the portfolio consisting of 14 established prescription brands from Novartis for a cash consideration of US$ 293 million. These brands have combined annualized revenues of approximately US$ 160 million and address medical conditions across several therapeutic areas. Under the terms of the agreements, Novartis will continue to distribute these brands, for a certain period, pending transfer of all marketing authorizations to Sun Pharma's subsidiary. The acquired brands will be marketed by a reliable and established local marketing partner under the Sun Pharma label. The local marketing partner will also be responsible for distribution of the brands.

On 4 May 2016, Sun Pharma and International Centre for Genetic Engineering and Biotechnology (ICGEB) signed an agreement to develop a novel botanical drug for treatment of dengue. Through this agreement Sun Pharma will follow up on earlier pre-clinical collaboration between ICGEB and erstwhile Ranbaxy Laboratories. Sun Pharma will develop Cipa, a botanical drug following a drug registration process similar to a new chemical entity, consisting of all required in-vitro, in-vivo, pre-clinical and clinical studies meeting all regulatory standards of India and other regulatory agencies worldwide. A botanical drug is a plant-derived medicinal product that is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans. On 4 June 2016, Sun Pharma announced that as a part of its manufacturing consolidation in the US, one of its wholly owned subsidiaries has entered into an agreement with Frontida BioPharm, Inc. (Frontida) for divestment of its two oral solid dosage manufacturing facilities located at Philadelphia, PA, and Aurora, IL, both in the US, along with 15 related pharmaceutical products. In connection with the transaction, Frontida has agreed to continue manufacturing certain products for Sun Pharma at these facilities on a contract basis for a predetermined period.

The Board of Directors of Sun Pharma at its meeting held on 23 June 2016 approved buyback of fully paid up equity shares of the company through the tender offer route at Rs 900 per share. The purpose of the buyback is to return surplus funds to the equity shareholders and thereby, enhancing the overall returns to shareholders.

On 18 July 2016, Sun Pharma and Sun Pharma Advanced Research Company Ltd. (SPARC) announced a licensing arrangement for SPARC's ELEPSIA XR (Levetiracetam Extended Release tablets). As per the agreement, SPARC will license ELEPSIA to a wholly-owned subsidiary of Sun Pharma for the US market. SPARC will receive an up-front payment of US$10 million from Sun Pharma. It is also eligible for certain additional milestone payments and defined royalties linked to any future sales of ELEPSIA XR.

On 27 July 2016, Sun Pharma and Almirall announced a licensing agreement on the development and commercialization of tildrakizumab for psoriasis in Europe. Under terms of the license agreement, Almirall will pay Sun Pharma an initial upfront payment of US $50 million. Sun Pharma will be eligible to receive development and regulatory milestone payments and, additionally, sales milestone payments and royalties on net sales. Almirall will be able to lead European studies, and participate in larger global clinical studies for psoriasis indication subject to the terms of the Sun Pharma - Merck agreements, as well as certain cost sharing agreements. Sun Pharma will continue to lead development of tildrakizumab for other indications, where Almirall will have right of first negotiation for certain indications in Europe.

On 6 September 2016, Sun Pharma announced that it has signed a strategic distribution alliance with Mitsubishi Tanabe Pharma Corporation, Japan for 14 prescription brands. Under this alliance, Mitsubishi Tanabe Pharma Corporation will market and distribute all the 14 brands as well as provide information on their proper use to healthcare professionals.

On 19 October 2016, Sun Pharma and International Centre for Genetic Engineering and Biotechnology (ICGEB) announced their new collaboration for development of a dengue vaccine, targeted against all the four serotypes of Dengue virus that cause disease in humans. According to the agreement, Sun Pharma will fund and support further development of the vaccine candidate and existing ICGEB Know-How and Patents. ICGEB will grant Sun Pharma exclusive rights and licenses for development and commercialization of this vaccine globally. ICGEB will receive pre-defined royalty and milestone payments.

On 26 October 2016, Sun Pharmaceutical Industries announced the execution of definitive agreements by its wholly owned subsidiary for the acquisition of 100% of Ocular Technologies, Sarl (OTS), a portfolio company of Auven Therapeutics (Auven), an international private equity company focused on accelerated development of breakthrough therapeutic drugs. OTS owns exclusive, worldwide rights to Seciera (cyclosporine A, 0.09% ophthalmic solution). Sun Pharma will pay Auven US$ 40 million upfront, plus contingent development milestones and sales milestones as well as tiered royalty on sales of Seciera as consideration for this acquisition.On 23 November 2016, Sun Pharma announced the execution of definitive agreements by its wholly owned subsidiary for the acquisition of 85.1% ofJSC Biosintez, a Russian pharmaceutical company engaged in manufacture and marketing of pharmaceutical products in Russia and CIS region. The equity consideration for the 85.1% stake is US$ 24 million. Sun Pharma would also assume a debt of approximately US$ 36 million as part of this transaction. Biosintez is a Russian pharmaceutical company focusing on the hospital segment with annual revenues of approximately US$ 52 million for 2015. It has a manufacturing facility in Penza region with capabilities to manufacture a wide variety of dosage forms including pharmaceuticals for injections, blood substitutes, blood preservatives, ampoules, tablets, ointment, creams, gels, suppositories, APIs, etc.

On 28 November 2016, Sun Pharma announced the launch of a branded ophthalmic product BromSite 0.075% in the US market. It was the first branded product launched by the company in the USA following its focus on Specialty Business.

On 12 December 2016, Sun Pharma and Israel-based Moebius Medical announced that they have entered into an exclusive worldwide licensing deal to further develop MM-II, a novel pharmaceutical candidate for the treatment of pain in osteoarthritis. According to the agreement, Sun Pharma will fund further development of Moebius Medical's lead product, MM-II, and undertake its global commercialization. Moebius Medical will conduct requisite pre-clinical studies, and will assume responsibility for product development and manufacturing through the end of Phase-II studies. Sun Pharma will assume responsibility for further clinical studies, regulatory submissions and product commercialization. Moebius Medical will receive an upfront payment, development-based and sales-based milestone payments, and tiered royalties on sales from Sun Pharma.

On 22 December 2016, Sun Pharma announced its plans to acquire a branded oncology product Odomzo from Novartis. The agreement was signed for an upfront payment of US$ 175 million and additional milestone payments. Odomzo (Sonidegib) was approved by the USFDA in July 2015. Odomzo is a hedgehog pathway inhibitor indicated for the treatment of adult patients with locally advanced basal cell carcinoma (laBCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.

On 4 January 2017, Sun Pharma announced successful Phase 3 confirmatory clinical trial results for Seciera for the treatment of dry eye disease. Seciera is being developed by Ocular Technologies, a company acquired by Sun Pharma. Following this acquisition, Sun Pharma owns exclusive, worldwide rights to Seciera and is developing it to commercialize for global markets including US, Europe, and Japan, as well as several emerging markets.

On 14 March 2017, Sun Pharmaceutical Industries announced that USFDA will lift the Import Alert imposed on the company's Mohali, Punjab manufacturing facility and remove the facility from the Official Action Initiated (OAI) status. This proposed action will clear the path for Sun Pharma to supply approved products from the Mohali facility to the US market, subject to normal USFDA regulatory requirements. The Mohali facility was inherited by Sun Pharma as part of its acquisition of Ranbaxy Laboratories in 2015. The USFDA had taken action against the Mohali facility in 2013 when it ordered the facility to be fully subject to Ranbaxy's Consent Decree of Permanent Injunction. Certain conditions of the consent decree will continue to be applicable to the Mohali facility.

On 27 June 2017, Sun Pharmaceutical Industries and National Institute of Virology (NIV), Pune, an institution of the Indian Council of Medical Research, Department of Health Research, Ministry of Health and Family Welfare, New Delhi announced that they have signed an agreement for testing phytopharmaceutical, biologic and chemical entities developed by Sun Pharma against Zika, Chikungunya and Dengue viruses. Sun Pharma will provide drug molecules to NIV for testing against Zika, Chikungunya and Dengue in model systems. Candidate molecules with encouraging data will then be taken forward for commercial development.

On 4 July 2017, Sun Pharmaceutical Industries and Samsung BioLogics announced a strategic long-term manufacturing agreement for Tildrakizumab, an investigational IL-23p19 inhibitor being evaluated for the treatment of moderate to severe plaque psoriasis. According to the agreement, Sun Pharma has appointed Samsung BioLogics to manufacture Tildrakizumab. The approximate value of the contract will be US$ 55.5 million. The regulatory filings associated with tildrakizumab have been accepted for review by the U.S. Food and Drug Administration and the European Medicines Agency (EMA).

On 16 January 2018, Sun Pharmaceutical Industries announced that its wholly owned subsidiaries have reached an agreement with Ironwood Pharmaceuticals, Inc. and Allergan plc to resolve the patent litigation regarding submission of an Abbreviated New Drug Application (ANDA) for a generic version of Linzess (Linaclotide capsules) in the US. Pursuant to the terms of the settlement, Ironwood Pharmaceuticals and Allergan will grant, the wholly owned subsidiaries of Sun Pharma, a license to market a generic version of Linzess in the United States beginning 01 February 2031 (subject to USFDA approval) or earlier under certain circumstances.

During the FY2019, Sun Pharma has received USFDA approval for its New Drug Application (NDA) of XELPROSTM (latanoprost ophthalmic emulsion 0.005%) used for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. XELPROSTM is the first and only form of latanoprost that is not formulated with benzalkonium chloride (BAK), a commonly used preservative in topical ocular preparations. XELPROSTM was launched in the US in January 2019.

The company has launched ILUMYATM (tildrakizumab-asmn) 100 mg/mL in the US for treating moderate-to-severe psoriasis in October 2018. The company has received a good initial response for the product and we expect ramp-up in ILUMYATM sales in the US over the next few years. The company also commenced a direct-to-consumer advertising initiative for ILUMYATM in the US.

Sun Pharma also received approval from the Australian Therapeutic Goods Administration (TGA) for ILUMYATM during the year. The product has already been commercialised in Australia.

During the year 2018-19 the company received USFDA approvals for CEQUATM (cyclosporine ophthalmic solution 0.09%). CEQUATM increases tear production in patients with dry eyes. It is the first and only approved dry eye treatment to combine cyclosporine A with nanomicellar technology. CEQUATM will be commercialised in the US in FY20.

In July 2018, Sun Pharma announced the USFDA approval for INFUGEMT (gemcitabine in 0.9% sodium chloride injection), for intravenous use in a ready-to-administer (RTA) bag. INFUGEMT uses a proprietary technology, which allows cytotoxic oncology products to be pre-mixed in a sterile environment and supplied to the prescribers in RTA infusion bags. These RTA bags will provide greater safety, by preventing problems of over-dosing or under-dosing and eliminating contamination risk. INFUGEMT was commercialised in the US in April 2019.

During the fiscal 2020, Sun Pharma announced licensing agreements with a subsidiary of China Medical System Holdings Ltd. (CMS) for the development and commercialisation of two of its specialty products - Tildrakizumab (for psoriasis and psoriatic arthritis) and Cyclosporine A 0.09% (CsA) eye drops (for dry eye disease) in Greater China.

In July 2019, Sun Pharma announced the US launch of EZALLOR SPRINKLET (Rosuvastatin) capsules for the treatment of three types of elevated lipid disorders in people who have difficulty swallowing, a problem that is estimated to affect approximately 30-35% of long-term care residents. With the introduction of EZALLOR SPRINKLE, Sun Pharma continued its commitment of providing a portfolio of innovative formulation products to address the needs of a specific patient segment.

In August 2019, Sun Pharma announced the filing of an application in Japan for manufacturing and marketing authorisation of ILUMYA (Tildrakizumab) for moderate-to-severe psoriasis with the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. Sun Pharma is committed to growing its global dermatology franchise, with ILUMYATM as its lead product.

Further in August 2019, Sun Pharma entered into a global licensing agreement with the CSIR - Indian Institute of Chemical Technology, Hyderabad (CSIR-IICT), for patents related to certain compounds with potential therapeutic activity across multiple indications in Sun Pharma's specialty focus areas. Under the terms of the license agreement, Sun Pharma gets exclusive global license for the said patents and any other future patents covered in the agreement. Sun Pharma paid CSIR-IICT an upfront payment and will also pay for potential development, regulatory and sales milestone payments totalling up to Rs 2.40 Billion, plus royalties on net sales from commercialisation of the products developed using these patents.

In August 2019, Sun Pharma granted an exclusive license to a subsidiary of China Medical System Holdings Ltd. (CMS) to develop and commercialise seven generic products in Mainland China. Till date, Sun Pharma and the CMS collaboration covers a total of eight generic products, with an addressable market size of about USD 1 Billion (as per IQVIA data) in Mainland China. This collaboration gives Sun Pharma an entry into the Chinese generic pharmaceutical market.

In November 2019, Sun Pharma entered into a licensing agreement with AstraZeneca UK Ltd. (AstraZeneca) to introduce certain novel ready to use (RTU) infusion oncology products in China.

In January 2020, Sun Pharma entered into exclusive licensing and supply agreements with Rockwell Medical Inc. (Rockwell), to commercialise Rockwell's Triferic, a proprietary iron replacement and haemoglobin maintenance drug, for treating anaemia in hemodialysis patients in India.

In February 2020, Sun Pharma launched ABSORICA LDT (isotretinoin) capsules in the US for the management of severe recalcitrant nodular acne in patients 12 years of age and older. ABSORICA LD is the only isotretinoin formulation to feature Sun Pharma's micronisation technology, which utilises micronised particles to optimise absorption at a 20% lower dose.

In March 2020, Sun Pharma committed to donate Hydroxychloroquine (HCQS), Azithromycin, and other related drugs and hand sanitisers to support India's COVID-19 response. It also donated HCQS in the US market.

In March 2020, Sun Pharma launched a buyback offer in India to buy back 40 Million shares at a price up to Rs 425 per equity share, totalling to about Rs 17 billion.

The Board of Directors of the Company at its meeting held on 31 July 2020, approved the Scheme of Amalgamation and Merger of Sun Pharma Global FZE (wholly owned subsidiary of the Company) with Sun Pharmaceutical Industries Limited, and their respective members and creditors which inter-alia, envisages merger of Sun Pharma Global FZE into the Company. The approval of the only secured creditor has been received during the quarter under review. The Company is convening separate meetings of shareholders and unsecured creditors of the Company on 16 March 2021 to seek the approval of the Scheme as directed by National Company Law Tribunal. The Scheme shall be effective post completion of all necessary formalities and procedures and accordingly, the above unaudited standalone financial results do not reflect the impact on account of the Scheme.

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Flash News 16-Apr-2021
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