About
Sun Pharmaceuticals Industries Ltd
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.
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 October 2019, the Company commercialised CEQUA (cyclosporine ophthalmic solution) 0.09% in the US. It launched DRIZALMA SPRINKLE (duloxetine delayed-release capsules) in the US for oral use.
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.
In 2021, the Company launched ILUMYA, an innovative drug in Japan. It commenced Phase-3 clinical trials for psoriatic arthritis. It initiated Phase-2 clinical trials for a potential oral treatment for atopic dermatitis and moderate to severe plaque psoriasis. It commenced Phase-2 trials for a potential treatment for knee pain in patients with symptomatic knee osteoarthritis.
During the year 2021, Company launched 96 products in the domestic market, including the anti-epileptic Brevipil (Brivaracetam) and FluGuard (Favipiravir). It supplied drugs like Remdesivir, Itolizumab, Hydroxychloroquine (HCQS), Favipiravir and Liposomal Amphotericin B in the market for treatment of COVID-19 and associated ailments.
National Company Law Tribunal (NCLT) vide its Order dated August 31, 2021, sanctioned the Scheme of Amalgamation and Merger of Sun Pharma Global FZE (Transferor Company), an indirect wholly owned subsidiary of the Company with Sun Pharmaceutical Industries Limited (Company), which inter-alia, envisages merger of Sun Pharma Global FZE into the Company, effective from October 1, 2021 with appointed date as January 1, 2020.
The Board of Directors of the Company at its meeting held on May 30, 2022 has approved the Scheme of Amalgamation of Sun Pharmaceutical Medicare Limited, Green Eco Development Centre Limited, Faststone Mercantile Company Private Limited, Realstone Multitrade Private Limited, Skisen Labs Private Limited, Wholly-owned Subsidiaries of the Company with the Company.
During the year 2022, the Company entered into License and Supply Agreements for Winlevi (clascoterone cream 1%) with Cassiopea SpA. Winlevi was approved by the United States Food and Drug Administration (USFDA) in August-2020 as a novel drug mechanism for the topical treatment of acne in patients 12 years and older. In March 2022, Sun Pharma reiterated the clinical profile of Winlevi by presenting data from two pivotal Phase 3 clinical trials of Winlevi for the topical treatment of acne vulgaris.
During the year 2022, the Company received final USFDA approval for its Abbreviated New Drug Application (ANDA) for generic Amphotericin B Liposome for injection, 50 mg/vial single-dose vial. In June 2021, Sun Pharma entered into an agreement with Celgene Corporation, a wholly-owned subsidiary of Bristol Myers Squibb, for a generic version of Revlimid (lenalidomide capsules) in the US.
In June 2021, Sun Pharma and Ferring Pharmaceuticals entered into licensing agreement for co-marketing CARITEC, an innovative obstetric drug for preventing post-partum haemorrhage (PPH).
In September 2021, Sun Pharma launched a novel formulation in cough syrup, Chericof 12 in India.
Sun Pharmaceuticals Industries Ltd
Chairman Speech
Dear Shareholders,
I am happy to write to you on the completion of a good year with strong
performance across multiple parameters.
FY22 witnessed robust top-line and EBITDA growth with global revenues
crossing the US$ 5 billion mark and adjusted net profit surpassing the US$ 1 billion mark
for the first time in Sun Pharma's history. All geographies did well, recording
double-digit growth, while profitability improved despite rising costs.
Normalcy is returning to economic activities globally.
Patient visits to doctor clinics are improving and new product launches
are gaining traction.
Our global consolidated revenues grew by 15.6% to Rs 384 Billion while
EBITDA grew by 23.6% to Rs 101 Billion with EBITDA margins expanding by 170bps to 26.5%
over the previous year. Adjusted net profit (excluding exceptional items) was up by about
29% to Rs 76 Billion.
Excluding exceptional items, ROCE improved by 288bps to 16.4%, ROIC by
306bps to 21% while ROE improved by 256bps to 15%.
The contribution of our global specialty business has nearly doubled
from 7% of consolidated revenues in FY18 to about 13% in FY22.
Operational performance
For FY22, India formulation sales were at Rs 127 Billion, up 23% and
accounted for about 33% of overall revenues. Excluding the contribution of COVID products,
the underlying business performed well, with about 20% growth over the previous year.
Our India business outperformed the average industry growth, driven by
our leading presence in chronic segments coupled with our strong brand equity with
doctors. As per AIOCD AWACS March 2022 data, our market share increased to 8.34% on MAT
basis from 8.17% in the previous year.
As per SMSRC data for February 2022, Sun Pharma ranks No. 1 by
prescriptions with 11 different classes of doctors. We continued our new launches momentum
with 77 new product introductions in India.
The India field force expansion undertaken in FY21 met with good
success and the new field force achieved its targets ahead of time.
Revenues in the US grew by about 13% to Rs 114 Billion and accounted
for approximately 30% of our consolidated revenues for FY22. Specialty sales in US
continued to gain traction. While the generics business continued to face price erosion,
we were able to partly compensate it through new launches and an efficient supply chain.
Our subsidiary, Taro, recorded about 2% growth in overall revenues to
US$ 561 Million. During the year, Taro acquired Alchemee (formerly The Proactiv Company)
from Galderma, including the Proactiv? brand for acne treatment. The acquisition further
strengthened Taro's OTC dermatology portfolio.
Our Emerging markets (EM) sales grew by 16% to Rs 67 Billion and
contributed about 18% of our consolidated revenues.
In local currency terms, large markets like Russia, Brazil and Romania
recorded strong double-digit growth. Post the close of the financial year, Sun Pharma
expanded its OTC presence in Romania by acquiring Uractiv™ OTC portfolio from
Fiterman Pharma. It is the number one brand in its category and the portfolio comprises
food supplements including minerals, vitamins and adjuvants; cosmetics and medical devices
used for maintaining urinary tract health.
Our sales in the Rest of World (RoW) markets grew by 11% to Rs 54
Billion and contributed about 14% to consolidated revenues. Growth was driven by higher
sales in Western Europe and ramp-up in Ilumya sales in Australia and Japan. Odomzo also
gained traction in RoW markets.
Research & Development (R&D)
Our R&D investments were approximately Rs 22 Billion, at 5.8% of
overall sales. During the year, we filed approximately 200 formulation dossiers globally.
We continued our R&D efforts to develop differentiated generics and innovative
specialty products. Some of the clinical trials for our specialty products got delayed
during FY22 due to the pandemic but are expected to gradually normalise in FY23.
We have multiple R&D centres and a strong R&D team which
enables development of new products for various markets globally. We remain disciplined in
identifying future R&D projects for the US generics market and the focus is on
developing complex products. Investments for developing the long-term specialty pipeline
are expected to continue and R&D investments are expected to increase as clinical
trials for specialty products gain traction.
We continue to focus on improving the efficiency and productivity of
our R&D operations, targeted at faster new product launches and ahead of competition.
Specialty business performance
Global specialty revenues recorded a strong 39% growth to reach US$ 674
million. We witnessed a strong traction in global Ilumya sales, which were up by about 81%
to US$ 315 million. Cequa, Odomzo and Levulan were the other contributors to the ramp-up
in the specialty business.
During the year, we in-licensed and commercialised Winlevi, an
anti-acne product in the US market. Given its new mechanism of action, the medical
community has shown good interest in prescribing the product to their patients.
Progress on specialty R&D pipeline - Sun Pharma's specialty
R&D pipeline has four molecules undergoing clinical trials:
a. Ilumya - is undergoing Phase-3 clinical trials for psoriatic
arthritis. A successful Phase-3 trial, subject to regulatory approval, is likely to expand
the addressable market for Ilumya.
b. SCD-044 ials as a potential oral treatment for atopic
dermatitis and moderate to severe plaque psoriasis. SCD-044 is a selective S1PR1 modulator
with good cardiac safety profile.
c. MM-II - is currently in Phase-2 trials as a potential
treatment for knee pain in patients with symptomatic knee osteoarthritis. MM-II is a
product with empty multi-lamellar liposomes for treatment of pain in osteoarthritis.
d. GL0034 - a GLP-1R (Glucagon-Like Peptide-1 Receptor) agonist
- is undergoing Phase-1 clinical trials for treating diabetes. The pre-clinical data had
demonstrated significant outcomes on various diabetic parameters, such as glucose
reduction, decrease in HbA1c, augmented insulin secretion, lowering of glucagon level,
meaningful reduction in triglyceride levels and larger body weight reduction.
We are enthused about the pre-clinical data and look forward to
validating it in human trials.
CGMP COMPLIANCE
With economies worldwide returning to normalcy and the resumption of
international travel, global regulatory agencies have re-initiated physical visits to
manufacturing facilities for cGMP inspections. During the year, many of our manufacturing
plants underwent such inspections by multiple regulatory agencies. Adherence to global
cGMP standards is a key priority for us, and we have an unwavering focus on 24x7
compliance to ensure continuity of supplies to our customers and patients worldwide.
After close of the year, the USFDA inspected the Halol (Gujarat)
facility and issued Form-483 with 10 observations. We will submit a comprehensive response
including the corrective actions to be undertaken for addressing the observations within
the stipulated timeframe, to the USFDA. We are fully committed to meeting all cGMP
standards and will work closely with the USFDA to resolve these observations.
Efficiency improvement
Our focus has always been on sustainable cost reduction via technology
interventions and process enhancements. We are also directing our efforts to reduce
working capital deployment across our businesses. Sustained efforts are being made to
further improve our manufacturing efficiencies, optimise our manufacturing footprint and
reduce overall fixed costs.
Debt reduction
Debt repayment during the year was about US$ 355 million; over the last
three years, we repaid debt of about US$ 1.38 billion. At year-end, Sun Pharma had a
strong net cash position of about US$ 2 billion.
Overall outlook
All our businesses are positioned for growth, and we expect
high-single-digit to low-double-digit consolidated topline growth for FY23. Ramp-up in our
global specialty business is expected to continue. As business operations normalise
globally, overall expenses are expected to increase. Our R&D investments will be about
7-8% of sales in FY23 with increased spending expected on clinical trials for specialty
products.
Top priorities for FY23
• Sustainable and profitable business growth
• Supply chain continuity along with focus on inventory
optimization
• Continued focus on cost and operational efficiency
• Increased investments in IT to facilitate business and digital
transformation
• Focus on improving overall return ratios
• Sustained efforts on reducing carbon footprint, water
consumption and environmental impact
Our employees are our key assets. Over the last two years, they have
worked hard to ensure business continuity despite the multiple pandemic-induced
disruptions, thus enabling us to maintain supplies of our products in various markets
while ensuring overall productivity and without compromising on safety protocols.
We are grateful to our Board of Directors for their guidance and
support.
Your support to us as a shareholder is of vital importance, and we hope
that you will continue to repose your confidence in us in the future as well.
Warm regards,
| Dilip Shanghvi |
| Managing Director |
| Sun Pharmaceutical Industries Limited |
Sun Pharmaceuticals Industries Ltd
Company History
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.
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 October 2019, the Company commercialised CEQUA (cyclosporine ophthalmic solution) 0.09% in the US. It launched DRIZALMA SPRINKLE (duloxetine delayed-release capsules) in the US for oral use.
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.
In 2021, the Company launched ILUMYA, an innovative drug in Japan. It commenced Phase-3 clinical trials for psoriatic arthritis. It initiated Phase-2 clinical trials for a potential oral treatment for atopic dermatitis and moderate to severe plaque psoriasis. It commenced Phase-2 trials for a potential treatment for knee pain in patients with symptomatic knee osteoarthritis.
During the year 2021, Company launched 96 products in the domestic market, including the anti-epileptic Brevipil (Brivaracetam) and FluGuard (Favipiravir). It supplied drugs like Remdesivir, Itolizumab, Hydroxychloroquine (HCQS), Favipiravir and Liposomal Amphotericin B in the market for treatment of COVID-19 and associated ailments.
National Company Law Tribunal (NCLT) vide its Order dated August 31, 2021, sanctioned the Scheme of Amalgamation and Merger of Sun Pharma Global FZE (Transferor Company), an indirect wholly owned subsidiary of the Company with Sun Pharmaceutical Industries Limited (Company), which inter-alia, envisages merger of Sun Pharma Global FZE into the Company, effective from October 1, 2021 with appointed date as January 1, 2020.
The Board of Directors of the Company at its meeting held on May 30, 2022 has approved the Scheme of Amalgamation of Sun Pharmaceutical Medicare Limited, Green Eco Development Centre Limited, Faststone Mercantile Company Private Limited, Realstone Multitrade Private Limited, Skisen Labs Private Limited, Wholly-owned Subsidiaries of the Company with the Company.
During the year 2022, the Company entered into License and Supply Agreements for Winlevi (clascoterone cream 1%) with Cassiopea SpA. Winlevi was approved by the United States Food and Drug Administration (USFDA) in August-2020 as a novel drug mechanism for the topical treatment of acne in patients 12 years and older. In March 2022, Sun Pharma reiterated the clinical profile of Winlevi by presenting data from two pivotal Phase 3 clinical trials of Winlevi for the topical treatment of acne vulgaris.
During the year 2022, the Company received final USFDA approval for its Abbreviated New Drug Application (ANDA) for generic Amphotericin B Liposome for injection, 50 mg/vial single-dose vial. In June 2021, Sun Pharma entered into an agreement with Celgene Corporation, a wholly-owned subsidiary of Bristol Myers Squibb, for a generic version of Revlimid (lenalidomide capsules) in the US.
In June 2021, Sun Pharma and Ferring Pharmaceuticals entered into licensing agreement for co-marketing CARITEC, an innovative obstetric drug for preventing post-partum haemorrhage (PPH).
In September 2021, Sun Pharma launched a novel formulation in cough syrup, Chericof 12 in India.
Sun Pharmaceuticals Industries Ltd
Directors Reports
Your Directors take pleasure in presenting the Thirtieth Annual Report
and Company's Audited Financial Statements for the financial year ended March 31, 2022
(‘FY2021-22').
FINANCIAL RESULTS
|
|
|
|
(Rs in Million) |
|
Standalone |
Consolidated |
|
Year ended March 31, 2022 |
*Year ended March 31, 2021 |
Year ended March 31, 2022 |
Year ended March 31, 2021 |
| Revenue from operations |
155,859.8 |
141,160.5 |
386,544.9 |
334,981.4 |
| Profit before exceptional item and tax |
21,273.9 |
9,451.3 |
90,481.4 |
71,055.1 |
| Exceptional Item |
18,205.3 |
895.6 |
45,668.2 |
43,061.4 |
| Profit before tax but after exceptional item |
3,068.6 |
8,555.7 |
44,813.2 |
27,993.7 |
| Profit/(Loss) after tax |
(999.9) |
8,424.0 |
34,058.2 |
22,846.8 |
| Opening balance in Retained Earnings |
159,645.5 |
140,052.7 |
365,980.9 |
353,200.5 |
| Closing balance in Retained Earnings |
136,120.8 |
159,645.5 |
376,456.5 |
365,980.9 |
*Refer Note 54(12) of Standalone Financial Statements
MATERIAL CHANGES AND COMMITMENTS AFFECTING THE FINANCIAL POSITION OF
THE COMPANY, BETWEEN THE END OF THE FINANCIAL YEAR AND THE DATE OF THIS REPORT
There have been no material changes and commitments affecting the
financial position of the Company, between the end of the financial year and the date of
this report.
CONSOLIDATED ACCOUNTS
The consolidated financial statements for the year ended March 31,
2022, have been prepared in accordance with Indian Accounting Standards (Ind AS) notified
under the Companies (Indian Accounting Standards) Rules, 2015.
DIRECTORS' RESPONSIBILITY STATEMENT
Pursuant to the requirements under Section 134(5) read with Section
134(3)(c) of the Companies Act, 2013 (‘Act') with respect to Directors'
Responsibility Statement, it is hereby confirmed that:
a) in the preparation of the annual accounts for the financial year
ended March 31, 2022, the applicable accounting standards have been followed and there are
no material departures from the same;
b) the Directors have selected such accounting policies and applied
them consistently and made judgments and estimates that are reasonable and prudent so as
to give a true and fair view of the state of affairs of the Company as at March 31, 2022,
and of the loss of the Company for the year ended on that date;
c) the Directors have taken proper and sufficient care for the
maintenance of adequate accounting records in accordance with the provisions of the Act
for safeguarding the assets of the Company and for preventing and detecting fraud and
other irregularities;
d) the Directors have prepared the annual accounts on a going concern
basis;
e) the Directors have laid down internal financial controls to be
followed by the Company and that such internal financial controls are adequate and were
operating effectively; and
f) the Directors have devised proper systems to ensure compliance with
the provisions of all applicable laws and that such systems were adequate and operating
effectively.
MANAGEMENT DISCUSSION AND ANALYSIS
The Management Discussion and Analysis as prescribed under Part B of
Schedule V read with Regulation 34(3) of the Listing Regulations is provided in a separate
section and forms part of this Report.
DIVIDEND
During the year under review, your Directors at their meeting held on
January 31, 2022 declared an interim dividend of Rs 7/- (Rupees Seven only) per equity
share of Rs 1/- (Rupee One only) each [previous year Rs 5.50/- (Rupees Five and Paisa
Fifty only) per equity share of Rs 1/- (Rupee One only) each] for the year ended March 31,
2022. The interim dividend was paid on February 18, 2022 to those shareholders who held
shares as on February 10, 2022, being the record date.
In addition to above, your Directors have recommended a final dividend
of Rs 3/- (Rupees Three only) per equity share of Rs 1/- (Rupee One only) each [previous
year Rs 2/- (Rupees Two only) per equity share of Rs 1/- (Rupee One only) each] for the
year ended March 31, 2022, subject to the approval of the equity shareholders at the
ensuing 30th Annual General Meeting of the Company.
The total dividend payout for FY2021-22 would be Rs 10/- (Rupees Ten
only) per equity share of Rs 1/- (Rupees One only) each [previous year Rs 7.50/- (Rupees
Seven and Paisa Fifty only) per equity share of Rs 1/- (Rupee One only) each].
The dividend payout is in accordance with the Company's Dividend
Distribution Policy. The policy is available on the website of the Company and can be
accessed through the web link: https://sunpharma.com/policies/.
TRANSFER TO RESERVES
The Directors do not propose any transfer to reserve.
CHANGES IN CAPITAL STRUCTURE
During the year under review there was no change in the Capital
Structure of the Company.
CREDIT RATING
ICRA Ltd. has reaffirmed the highest credit rating of ‘[ICRA]
A1+'/ ‘[ICRA] AAA (Stable)' for the bank facilities, short term/ long term borrowings
and commercial paper programs of the Company.
Further, CRISIL Ltd. has also reaffirmed the highest credit rating of
‘CRISIL A1+ and CRISIL AAA/Stable' for short tern & long term bank facilities and
commercial paper programs of the Company.
SUBSIDIARIES/ JOINT VENTURES/ ASSOCIATES
The statement containing the salient features of the Financial
Statements of the Company's subsidiaries/ joint ventures/ associates is given in Form AOC
- 1, provided in Notes to the Consolidated Financial Statements, forming part of the
Annual Report.
The highlights of performance of subsidiaries, joint ventures and
associates and their contribution to the overall performance of the Company during the
financial year under review is given under Annexure ‘A' to the Consolidated Financial
Statements forming part of the Annual Report.
Details pertaining to entities that became subsidiaries/ joint
ventures/ associates and those that ceased to be the subsidiaries/ joint ventures/
associates of the Company during the year under review are provided in the notes to the
Consolidated Financial Statements, forming part of the Annual Report.
SCHEME OF AMALGAMATION
1. National Company Law Tribunal (NCLT) vide its Order dated August 31,
2021, sanctioned the Scheme of Amalgamation and Merger of Sun Pharma Global FZE
("Transferor Company"), an indirect wholly owned subsidiary of the Company with
Sun Pharmaceutical Industries Limited ("Company") pursuant to Section 234 read
with Sections 230 to 232 of the Companies Act, 2013 and the relevant rules and regulations
made
thereunder. The Scheme is effective from October 1, 2021 with appointed
date as January 1, 2020 and Sun Pharma Global FZE has been merged with the Company.
2. The Board of Directors of the Company at its meeting held on May 30,
2022 has approved the Scheme of Amalgamation of Sun Pharmaceutical Medicare Limited, Green
Eco Development Centre Limited, Faststone Mercantile Company Private Limited, Realstone
Multitrade Private Limited, Skisen Labs Private Limited, Wholly-owned Subsidiaries of the
Company with the Company.
DIRECTORS AND KEY MANAGERIAL PERSONNEL
During the year, following were the changes in Directors/
Key Managerial Personnel:
1. Dr. Pawan Goenka has been appointed as the Independent Director
w.e.f. May 21, 2021 for a period of five years by the shareholders at the 29th Annual
General Meeting.
2. Ms. Rama Bijapurkar has been appointed as the Independent Director
w.e.f. May 21, 2021 for a period of five years by the shareholders at the 29th Annual
General Meeting.
3. Ms. Rekha Sethi retired and ceased to be the Independent Director
w.e.f. August 31, 2021 i.e. upon conclusion of the 29th Annual General Meeting.
4. Mr. Vivek Chaand Sehgal resigned as the Independent Director with
effect from September 1, 2021.
5. Mr. Sunil Ajmera resigned from the position of Company Secretary and
Compliance Officer w.e.f. the close of business hours of January 31, 2022.
6. Mr. Anoop Deshpande has been appointed as Company Secretary and
Compliance Officer effective from closure of business hours of January 31, 2022.
After the year end and up to the date of the Report,
following were the changes:
1. The Board of Directors at its meeting held on May
30, 2022, on the recommendation by Nomination and Remuneration
Committee, has approved the re-appointment and remuneration of Mr. Dilip Shanghvi as
Managing Director for further period of five years with effect from i.e. April 1, 2023 to
March
31, 2028, subject to approval of the shareholders at the 30th Annual
General Meeting.
2. The Board of Directors at its meeting held on May 30, 2022, on the
recommendation by Nomination and Remuneration Committee, has approved the re-appointment
of Mr. Gautam Doshi as Independent Director for further period of five years with effect
from
i.e. May 25, 2023 to May 24, 2028, subject to approval of the
shareholders at the 30th Annual General Meeting.
Mr. Sailesh T. Desai and Mr. Israel Makov Directors of the Company,
retire by rotation at the 30th Annual General Meeting.
The necessary disclosures required under the Companies Act, 2013 and
the SEBI (Listing Obligations & Disclosure Requirements) Regulations, 2015 and
Secretarial Standards-2 on General Meetings issued by the Institute of Company Secretaries
of India, for the above-mentioned appointments/ re-appointment are provided in the 30th
Annual General Meeting Notice of the Company.
DECLARATION BY INDEPENDENT DIRECTORS
The Company has received declarations from all the Independent
Directors confirming that they meet the criteria of independence as prescribed under
Section 149(6) of the Act and under Securities and Exchange Board of India (Listing
Obligations and Disclosure Requirements) Regulations, 2015 ("Listing
Regulations").
In the opinion of the Board, the Independent Directors fulfil the
conditions specified under the Act and Listing Regulations and are independent of the
management. The Board skill/ expertise/ competencies matrix of all the Directors,
including the Independent Directors is provided in the Corporate Governance Report forming
part of this Annual Report.
FAMILIARISATION PROGRAMME FOR THE INDEPENDENT DIRECTORS
In compliance with the requirements of Regulation 25(7) of the Listing
Regulations, the Company has put in place a Familiarisation Programme for the Independent
Directors to familiarise them with the Company, their roles, rights, responsibilities in
the Company, nature of the industry in which the Company operates, business model etc. The
details of the Familiarisation Programme conducted are available on the website of the
Company: https://sunpharma.com/policies/.
EVALUATION OF PERFORMANCE OF THE BOARD, ITS COMMITTEES AND INDIVIDUAL
DIRECTORS
During the year, annual performance evaluation of the Board and
Committees of the Board, individual Directors including the Chairman of the Company, was
carried out as per the criteria and process approved by Nomination and Remuneration
Committee, which is in line with the SEBI Guidance Note on Board Evaluation.
The Chairman and other members of the Board discussed upon the
performance evaluation outcome and concluded that they were satisfied with the overall
performance of the Board and Committees of the Board and Directors individually. The Board
also assessed the fulfillment of the independence criteria as specified in Listing
Regulations, by the Independent Directors of the Company and their independence from the
management.
The performance evaluation of the Non-Independent Directors including
the Chairman of the Company and performance of the Board as a whole was discussed at the
separate meeting of the Independent Directors.
REMUNERATION POLICY FOR DIRECTORS, KEY MANAGERIAL PERSONNEL AND OTHER
EMPLOYEES AND CRITERIA FOR APPOINTMENT OF DIRECTORS
For the purpose of selection of any Director, the Nomination and
Remuneration Committee identifies persons of integrity who possess relevant expertise,
experience and leadership qualities required for the position. The Committee also ensures
that the incumbent fulfils such criteria with regard to qualifications, positive
attributes, independence, age and other criteria as laid down under the Act, Listing
Regulations or other applicable laws and the diversity attributes as per the Board
Diversity Policy of the Company. The Board has, on the recommendation of the Nomination
and Remuneration Committee framed a Policy on remuneration of Directors, Key Managerial
Personnel and other Employees.
The salient features of the Remuneration Policy of the Company are as
under:
A. Guiding Principles for remuneration: The Company shall remunerate
all its personnel reasonably and sufficiently as per industry benchmarks and standards.
The remuneration shall be commensurate to retain and motivate the human resources of the
Company. The compensation package will, inter alia, take into account the experience of
the personnel, the knowledge & skill required including complexity of his job, work
duration and risks associated with the work, and attitude of the employee like positive
outlook, team work, loyalty etc.
B. Components of Remuneration: The following will be the various
remuneration components which may be paid to the personnel of the Company based on the
designation and class of the personnel.
a) Fixed compensation: The fixed salaries of the Company's personnel
shall be competitive and based on the individual personnel's responsibilities and
performance.
b) Variable compensation: The personnel of the Company may be paid
remuneration by way of variable salaries based on their performance evaluation. Such
variable salaries should be based on the performance of the individual against his short
and long term performance objectives and the performance of the Company.
c) Share based payments: The Board may, on the recommendation of the
Nomination and Remuneration Committee, issue to certain class of personnel a share and
share price related incentive program.
d) Non-monetary benefits: Senior management personnel of the Company
may, on a case to case basis, be awarded customary non-monetary benefits such as
discounted salary advance/ credit facility, rent free accommodation, Company cars with or
without chauffer, share and share price related incentive, reimbursement of electricity
and telephone bills etc.
e) Gratuity/group insurance: Personnel may also be awarded to group
insurance and other key man insurance protection. Further as required by the law necessary
gratuity shall be paid to the personnel.
f) Commission: The directors may be paid commission if approved by the
shareholders.
The shareholders may authorise the Board to declare commission to be
paid to any director of the Board.
The complete Policy as approved by the Board is available on the
website of the Company and can be accessed through the web link:
https://sunpharma.com/policies/.
Information as per Section 197 (12) of the Act read with Rule 5(1) of
the Companies (Appointment and Remuneration of Managerial Personnel) Rules, 2014 is
provided in ‘Annexure - A' to this Report. Further, the information pertaining to
Rule 5(2) & 5(3) of the Companies (Appointment and Remuneration of Managerial
Personnel) Rules, 2014, pertaining to the names and other particulars of employees is
available for inspection at the Registered office of the Company during business hours and
pursuant to the second proviso to Section 136(1) of the Act, the Report and the accounts
are being sent to the members excluding this. Any shareholder interested in obtaining a
copy of the same may write to the Company Secretary & Compliance Officer either at the
Registered/ Corporate Office address or by email to secretarial@sunpharma.com.
BOARD MEETINGS
The Board of Directors of the Company met 5 (Five) times during the
year under review. The dates of the Board meeting and the attendance of the Directors at
the said meetings are provided in detail in the Corporate Governance Report, which forms a
part of this Report.
COMMITTEES OF THE BOARD
As on March 31, 2022, the Board has 6 (six) Committees. Audit
Committee, Nomination and Remuneration Committee, Stakeholders Relationship Committee,
Risk Management Committee, Corporate Social Responsibility Committee and Corporate
Governance & Ethics Committee.
The details pertaining to the meetings and composition of the
Committees of the Board are included in the Corporate Governance Report, which forms part
of this Report.
RELATED PARTY TRANSACTIONS
The policy on Related Party Transactions as approved by the Board is
available on the website of the Company and can be accessed through the web link:
https://www. sunpharma.com/policies. All contracts/ arrangements/ transactions entered by
the Company during the year under review with the related parties were in the ordinary
course of business and on an arm's length basis.
As required under Section 134(3)(h) of the Act, details of transactions
entered with related parties under the Act exceeding ten percent of the annual
consolidated turnover as per the last audited financial statements are given in Form AOC-2
provided as ‘Annexure - B' to this Report.
INTERNAL CONTROLS
The Company believes that internal controls are the prerequisite of
governance and that action emanating out of agreed business plans should be exercised
within a framework of checks and balances. The Company has a well-established internal
controls framework, which is designed to continuously assess the adequacy, effectiveness
and efficiency of internal controls. The management is committed to ensuring an effective
internal controls environment, commensurate with the size and complexity of the business,
which provides an assurance on compliance with internal policies, applicable laws,
regulations, ensures accuracy of records, promotes operational efficiency, protects
resources and assets and overall minimize the risks.
INTERNAL FINANCIAL CONTROLS
The Company has a well-established internal financial controls
framework, which is designed to continuously assess the adequacy, effectiveness and
efficiency of internal financial controls. The management is committed to ensuring an
effective internal financial controls environment, commensurate with the size and
complexity of the business, which provides an assurance regarding the reliability of
financial reporting and the preparation of financial statements for external purposes in
accordance with generally accepted accounting principles.
GLOBAL INTERNAL AUDIT
An independent and empowered Global Internal Audit Function (GIA) at
the corporate level with support from a Big 4/ equally reputed audit firms, wherever
required, carries out risk-based audits. GIA audits all businesses to ensure that business
process controls are adequate and are functioning effectively. These reviews include
financial, operational and compliance controls and risk mitigation plans. The Company's
operating management closely monitors the internal control environment and ensures that
the audit recommendations are effectively implemented.
The Audit Committee of the Board monitors performance of the Internal
Audit Function, periodically reviews key findings and provides strategic guidance.
GIA's functioning is governed by the Audit Charter, duly approved by
the Audit Committee of the Board, which stipulates matters contributing to the proper and
effective conduct of the audit.
RISK MANAGEMENT
The Board of Directors has constituted a Risk Management Committee
which is entrusted with the responsibility of overseeing various organizational risks. The
Risk Management Committee also assesses the adequacy of mitigation plans to address such
risks. The Corporate Governance Report, which forms part of this report, contains the
details of Risk Management Committee of the Company. An overarching Risk Management Policy
which was approved by the Board is in place.
The Company has developed and implemented an integrated Enterprise Risk
Management (ERM) Framework through which it identifies, monitors, mitigates and reports,
key risks that impact the Company's ability to meet its strategic objectives.
The ERM team engages with all Function heads to identify internal and
external events that may have an adverse impact on the achievement of Company's objectives
and periodically monitors changes in both internal and external environment leading to
emergence of a new threat/risk. These risks are captured in a risk register with all the
relevant information such as risk area, risk description, risk rating, root cause and
mitigation plans, action items etc. The risk register is refreshed semi-annually. Risks
are categorised into various categories viz. Strategic, Financial, Operational,
Compliance, Cyber, Geo-Political etc. During FY 21-22, the focus was on reviewing
effectiveness of actions taken to mitigate the identified risks as well as to identify the
new risks and associated risk-mitigation plans, emerging out of constantly changing
geo-political situation across the globe.
Outcome of Enterprise Risk Assessments covering Company's various
businesses and functions, are one of the key input for the annual internal audit plan.
WHISTLE BLOWER POLICY/ VIGIL MECHANISM
To create enduring value for all stakeholders and ensure the highest
level of honesty, integrity and ethical behaviour in all its operations, the Company has
adopted a ‘Global Whistle Blower Policy' for Sun Pharmaceutical Industries Limited
and all its subsidiaries, in addition to the existing Global Code of Conduct that governs
the actions of its employees. Further details on vigil mechanism of the Company are
provided in the Corporate Governance Report, forming part of this Report.
AUDITORS Statutory Auditors
S R B C & Co LLP, Chartered Accountants, (Firm's Regn.
No. 324982E/ E300003), were appointed as the Statutory Auditors of the
Company for a period of 5 (five) years at the 25th Annual General Meeting of the Company
to hold office till the conclusion of the 30th Annual General Meeting of the Company.
In terms of provisions of sections 139 read with the Companies (Audit
and Auditors) Rules, 2014.S R B C & Co LLP, Chartered Accountants are eligible to be
re-appointed for a further term of 5 (five) years.
The Company has received the consent, certificate of eligibility and a
certificate issued by the Peer Review Board of the Institute of Chartered Accountants of
India (ICAI) in accordance with Sections 139, 141 and other applicable provisions of the
Act and Rules issued thereunder and as required under the Listing Regulations, from S R B
C & Co LLP, chartered Accountants.
Accordingly, the Board of Directors at its meeting held on May 30,
2022, based on the recommendation of the Audit Committee have approved and recommended the
reappointment of S R B C & Co LLP, Chartered Accountants, (Firm's Regn. No. 324982E/
E300003), as the Statutory Auditors, for a further period of 5 (five) years i.e. from the
conclusion of the 30th Annual General Meeting till the conclusion of the 35th Annual
General Meeting of the Company, for approval of the Shareholders of the Company at the
ensuing 30th Annual General Meeting.
The Auditor's Report for the financial year ended March 31, 2022, has
been issued with an unmodified opinion, by the Statutory Auditors.
Secretarial Auditor
The Board had appointed KJB & Co. LLP, Practicing Company
Secretaries, to undertake the Secretarial Audit of the Company for the financial year
ended March 31, 2022. The Secretarial Audit Report in the Form No. MR - 3 for the year is
provided as ‘Annexure - C1' to this Report.
The Secretarial Audit Report for the year does not contain any
qualification, reservation or adverse remark.
In accordance with the provision of Regulation 24A of the Listing
Regulations, Secretarial Audit of two material unlisted Indian subsidiaries of the Company
namely, Sun Pharma Laboratories Limited (SPLL) and Sun Pharma Distributors Limited (SPDL),
was undertaken by KJB &
Co. LLP, Practicing Company Secretaries, Mumbai and the Secretarial
Audit Reports issued by them are provided as ‘Annexure - C2' and ‘Annexure - C3'
respectively to this Report. The Secretarial Audit Reports for these material unlisted
Indian subsidiaries do not contain any qualification, reservation or adverse remark.
Cost Auditor
The Board has appointed K D & Co, Cost Accountants, (Firm's
Registration No. 004076) as Cost Auditor of the Company for conducting Cost Audit in
respect of Bulk Drugs & Formulations of your Company for the financial year 2022-23.
The Company is required to maintain Cost Records as specified by the
Central Government under Section 148(1) of the Act and accordingly, such accounts and
records are made and maintained by the Company.
CORPORATE SOCIAL RESPONSIBILITY
In compliance with the requirements of Section 135 of the Act read with
the Companies (Corporate Social Responsibility Policy) Rules, 2014, the Board of Directors
has constituted a Corporate Social Responsibility (CSR) Committee. The details of
membership of the Committee and the meetings held are detailed in the Corporate Governance
Report, forming part of this Report. The CSR Policy of the Company is available on the
website of the Company and can be accessed through the web link:
https://sunpharma.com/policies/.
The annual report on CSR activities containing details of expenditure
incurred by the Company and brief details on the CSR activities are provided in
‘Annexure - D' to this Report.
The Board has accorded its consent to set off the excess amount spent
by the Company on its CSR Activities against the requirement to spend in terms of Section
135 of the Companies Act, 2013 in any subsequent year(s).
BUSINESS RESPONSIBILITY & SUSTAINABILITY REPORT
The Business Responsibility and Sustainability Report of the Company
for the year ended March 31, 2022, is provided in a separate section and forms part of
this Annual Report and is also made available on the website of the Company at
https://sunpharma.com/investors-annual-reports- presentations/.
HUMAN RESOURCES
FY2021-22 was a very challenging year for everyone. Our 38,000+ strong
global workforce worked relentlessly to ensure medicines continue to reach patients who
rely on us. As lockdowns continued across the world, our teams being part of essential
services, ensured our 43 manufacturing sites, distribution centres, R&D centres and
sales offices worldwide continue to operate. We are grateful to our employees who made
this happen with a safety-first mind set. The top priority for the Human Resource function
was providing a safe work environment to employees globally.
Your Directors would like to take this opportunity to express their
gratitude and appreciation for the passion, dedication and commitment of the employees and
look forward to their continued contribution.
DISCLOSURE UNDER THE SEXUAL HARASSMENT OF WOMEN AT WORKPLACE
(PREVENTION, PROHIBITION AND REDRESSAL) ACT, 2013
Your Company strongly believes in providing a safe and harassment free
workplace for each and every individual working for the Company through various
interventions and practices. It is the continuous endeavour of the Management of the
Company to create and provide an environment to all its employees that is free from
discrimination and harassment including sexual harassment. The Company has adopted a
policy on prevention, prohibition and redressal of sexual harassment at workplace in line
with the provisions of the Sexual Harassment of Women at Workplace (Prevention,
Prohibition and Redressal) Act, 2013 and the Rules made thereunder.
The Company has arranged various interactive awareness workshops in
this regard for the employees at the manufacturing sites, R & D set ups &
corporate office during the year under review. The Company has submitted the Annual
Returns to the local authorities, as required under the above-mentioned Act.
During the financial year ended March 31, 2022, two complaints
pertaining to sexual harassment were received. The complaints were resolved and there are
no complaints pending as at the end of the financial year.
Your Company has complied with provisions relating to the constitution
of Internal Complaints Committee under the Sexual Harassment of Women at Workplace
(Prevention, Prohibition and Redressal) Act, 2013.
CORPORATE GOVERNANCE REPORT
Report on Corporate Governance and Certificate of the Auditors of the
Company regarding compliance of the conditions of Corporate Governance as stipulated in
Part C of Schedule V of the Listing Regulations, are provided in a separate section and
forms part of this Report.
SECRETARIAL STANDARDS
The Company has complied with the applicable Secretarial Standards as
amended from time to time.
LOANS, GUARANTEES & INVESTMENTS
The particulars of loans, guarantees and investments have been
disclosed in the Financial Statements.
PUBLIC DEPOSITS
The Company has not accepted any deposit from the Public during the
year under review.
CONSERVATION OF ENERGY, TECHNOLOGY ABSORPTION AND FOREIGN EXCHANGE
EARNINGS AND OUTGO
The information on conservation of energy, technology absorption and
foreign exchange earnings and outgo as stipulated under Section 134(3)(m) of the Act read
with Rule 8 of the Companies (Accounts) Rules, 2014, is provided as ‘Annexure - E' to
this Report.
SIGNIFICANT AND MATERIAL ORDERS PASSED BY THE REGULATORS OR COURTS OR
TRIBUNALS
There are no significant and material orders passed by the regulators
or courts or tribunals which impact the going concern status.
ANNUAL RETURN
The Annual Return as required under sub-section (3) of Section 92 of
the Companies Act, 2013 (‘the Act') in form MGT-7 is made available on the website of
the Company and can be accessed at https://sunpharma.com/investors-
annual-reports-presentations.
ACKNOWLEDGEMENTS
Your Directors wish to thank all stakeholders, employees and business
partners, Company's bankers, medical professionals and business associates for their
continued support and valuable cooperation.
The Directors also wish to express their gratitude to investors for the
faith that they continue to repose in the Company.
For and on behalf of the Board of Directors
|
Dilip Shanghvi |
Sailesh T. Desai |
| Place: Mumbai |
Managing Director |
Whole-time Director |
| Date: May 30, 2022 |
(DIN: 00005588) |
(DIN:00005443) |
Sun Pharmaceuticals Industries Ltd
Company Background
| Incorporation Year | 1993 |
| Registered Office | Sun Pharma Advanced Res.Centre,Tandalja
Vadodara,Gujarat-390020 |
| Telephone | 91-265-6615500,Managing Director |
| Fax | 91-265-2354897 |
Israel MakovDilip S Shanghvi| Company Secretary | Anoop Deshpande |
| Auditor | S R B C & Co LLP |
| Face Value | 1 |
| Market Lot | 1 |
| Listing | BSE,MSEI ,NSE, |
| Registrar | Link Intime India Pvt Ltd
C-101 247 Park,L B S Marg,Vikhroli West,Mumbai-400083 |
Sun Pharmaceuticals Industries Ltd
Company Management
| Director Name | Director Designation | Year |
|---|
| Dilip S Shanghvi | Managing Director | 2022 |
| Sudhir V Valia | Non-Exec & Non-Independent Dir | 2022 |
| Sailesh T Desai | Whole-time Director | 2022 |
| Israel Makov | Chairman (Non-Executive) | 2022 |
| Kalyanasundaram Subramanian | Whole-time Director | 2022 |
| Gautam Doshi | Non-Exec. & Independent Dir. | 2022 |
| Pawan Goenka | Lead Independent Director | 2022 |
| Rama Bijapurkar | Independent Director | 2022 |
| Anoop Deshpande | Company Sec. & Compli. Officer | 2022 |
| Sanjay K Asher | Additional Director | 2022 |
| Rolf Hoffmann | Independent Director | 2022 |
| AALOK SANGHVI | Whole Time Director | 2022 |
Sun Pharmaceuticals Industries Ltd
Listing Information
| Listing Information |
|---|
| BSE_SENSEX |
| NIFTY |
| BSE_500 |
| BSE_HC |
| BSE_100 |
| BSE_200 |
| BSEDOLLEX |
| CNX500 |
| CNXPHARMA |
| CNX100 |
| CNX200 |
| BSEGREENEX |
| BSECARBONE |
| NI15 |
| NFT100EQWT |
| BSEALLCAP |
| BSELARGECA |
| BSEMANUFAC |
| SENSEX50 |
| ESG100 |
| LMI250 |
| BSEDSI |
| BSELVI |
| BSEMOI |
| NFT50EQWT |
| NFT100LV30 |
| BSE100LTMC |
| NFTYLM250 |
| NFTYALV30 |
| NFTY200M30 |
| NFTYHEALTH |
| NF500M5025 |
Sun Pharmaceuticals Industries Ltd
Finished Product
| Product Name | Unit | Installed
Capacity | Production
Quantity | Sales
Quantity | Sales
Value |
|---|
| Sale of Products | NA | 0 | 0 | 0 | 15518.5 |
| Other Operating Revenue | NA | 0 | 0 | 0 | 67.48 |
| Others | NA | 0 | 0 | 0 | 0 |
| Conversion/Analytical Charges | NA | 0 | 0 | 0 | 0 |
| Income from Partnership Firm | NA | 0 | 0 | 0 | 0 |
| Lease Rental/Hire Charges | NA | 0 | 0 | 0 | 0 |
| Interest | NA | 0 | 0 | 0 | 0 |
| Bulk Drugs & Chemicals | Kg | 0 | 0 | 0 | 0 |
| Bulk Drugs & Chemicals | KL | 0 | 0 | 0 | 0 |
| Formulation | No | 0 | 0 | 0 | 0 |
| Tablets & Capsules | No | 0 | 0 | 0 | 0 |