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, sprays, inhalers, drug delivery systems, 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.
During year 2022-23, Company acquired Concert Pharmaceuticals, Inc. to strengthen global specialty product portfolio of Company.
It launched Sezaby in the US specifically indicated to treat seizures in infants; launched Odomzo; launched Cequa to expand commercial footprint and bring the global specialty portfolio to home market.
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, sprays, inhalers, drug delivery systems, 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.
During year 2022-23, Company acquired Concert Pharmaceuticals, Inc. to strengthen global specialty product portfolio of Company.
It launched Sezaby in the US specifically indicated to treat seizures in infants; launched Odomzo; launched Cequa to expand commercial footprint and bring the global specialty portfolio to home market.
Sun Pharmaceuticals Industries Ltd
Directors Reports
<dhhead>Board’s Report</dhhead>
Your Directors take pleasure in presenting the Thirty-first Annual
Report and Company’s Audited Financial Statements for the financial year ended March
31, 2023 (‘FY23’).
Financial Results
( in Million)
|
Standalone |
Consolidated |
|
Year ended |
Year ended |
Year ended |
Year ended |
|
March 31, 2023 |
March 31, 2022 |
March 31, 2023 |
March 31, 2022 |
| Revenue from operations |
208,121.4 |
155,859.8 |
438,856.8 |
386,544.9 |
| Profit before exceptional item and tax |
46,788.4 |
21,273.9 |
95,798.8 |
90,481.4 |
| Exceptional Item |
29,377.9 |
18,205.3 |
1,714.5 |
45,668.2 |
| Profit before tax but after exceptional item |
17,410.5 |
3,068.6 |
94,084.3 |
44,813.2 |
| Profit after tax |
16,907.2 |
(999.9) |
85,608.4 |
34,058.2 |
| Opening balance in Retained Earnings |
136,120.8 |
159,645.5 |
376,456.5 |
365,980.9 |
| Closing balance in Retained Earnings |
127,908.8 |
136,120.8 |
436,102.5 |
376,456.5 |
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, 2023
pursuant to Section 129(3) of the Companies Act, 2013, form part of this Annual Report.
Dividend
During the year under review, the Directors have declared an interim
dividend of 7.50/- (Rupees Seven and Paise Fifty only) per equity share of 1/- (Rupee One
only) each [previous year 7.00/- (Rupees Seven only) per equity share of 1/- (Rupee One
only) each] for the year ended March 31, 2023.
In addition to above, the Directors have recommended a final dividend
of 4.00/- (Rupees Four only) per equity share of 1/- (Rupee One only) each [previous year
3.00/- (Rupees Three only) per equity share of 1/- (Rupee One only) each] for the year
ended March 31, 2023, subject to the approval of the shareholders at the ensuing 31st
Annual General Meeting of the Company.
The total dividend payout for the FY23 is 11.50/- (Rupees Eleven and
paise fifty only) per equity share of
1/- each [previous year 10.0/- (Rupees Ten only) per equity share of
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,
https://sunpharma.com/policies.
Transfer to Reserves
The Directors do not propose any transfer to reserve.
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.
Changes in Capital Structure
During the year under review there was no change in the capital
structure of the Company.
Credit Rating
The highest credit rating has been reaffirmed by CRISIL and ICRA and
the ratings are disclosed in the Corporate Governance Report which forms part of this
Annual Report.
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
this Annual Report.
During the year under review, apart from the other acquisitions, the
Company has completed the acquisition of Concert Pharmaceuticals, Inc. which was a
strategic investment to strengthen global specialty product portfolio of the Company.
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.
Directors and Key Managerial Personnel
During the year, following were the changes in Director/ Key Managerial
Personnel:
1. Mr. Dilip Shanghvi (DIN: 00005588) is re-appointed as Managing
Director for a further period of 5 years, from April 1, 2023 to March 31, 2028 at the 30th
Annual General Meeting held on August 29, 2022.
2. Mr. Gautam Doshi (DIN: 00004612) is re-appointed as an Independent
Director for a second term of 5 years, from May 25, 2023 to May 24, 2028 at the 30th
Annual General Meeting held on August 29, 2022.
3. Mr. Sanjay Asher (DIN: 00008221) is appointed as an Independent
Director for a term commencing from November 1, 2022 till March 31, 2025, by the
shareholders vide resolution passed by Postal Ballot on January 27, 2023.
4. Mr. Israel Makov (DIN: 05299764) retired and ceased to be the
Chairman and Director upon the conclusion of 30th Annual General Meeting held
on August 29, 2022.
5. Mr. Kalyanasundaram Subramanian (DIN: 00179072) retired and ceased
to be the Director effective from February 13, 2023.
After the year end and upto the date of the Report, following were the
changes:
6. The Board of Directors at its meeting held on May 26, 2023, on the
recommendation by Nomination and Remuneration Committee, has approved the appointment of
Mr. Rolf Hoffmann as an Independent Director for a term of five years to be effective from
the date of allotment of Director Identification Number, subject to approval of the
shareholders.
7. The Board of Directors at its meeting held on May 26, 2023, on the
recommendation by Nomination and Remuneration Committee, has approved the appointment and
remuneration of Mr. Aalok Shanghvi (DIN: 01951829) as a Whole-time Director for a term of
five years effective from June 1, 2023, subject to approval of the shareholders.
Mr. Sudhir Valia Director of the Company, retires by rotation at the
ensuing 31st Annual General Meeting, and being eligible has offered himself for
re-appointment.
The necessary disclosures required under the Companies Act, 2013
("Act") and the SEBI (Listing Obligations & Disclosure Requirements)
Regulations, 2015 ("Listing Regulations") 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 31st 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 with the criteria of independence as prescribed under
Section 149(6) of the Act and the Regulation 16(1)(b) of the Listing Regulations. In the
opinion of the Board, the Independent Directors fulfil the conditions specified under the
Act and the Listing Regulations and are independent of the management.
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 Board discussed upon the outcome of performance evaluation 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 fulfilment
of the independence criteria by the Independent Directors of the Company and their
independence from the management as specified in the Listing Regulations.
The performance evaluation of the Non-Independent Directors and the
performance of the Board as a whole was discussed at the separate meeting of the
Independent Directors as well.
Remuneration policy for Directors, Key Managerial Personnel and Other
Employees and Criteria for appointment of Directors
The Company has in place a process for selection of any Director,
wherein the Nomination and Remuneration Committee identifies persons of integrity who
possess relevant expertise, experience and leadership qualities required for the position
and 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.
Further, the Company has 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 (b) Variable compensation (c) Share based
payments (d) Non-monetary benefits (e) Gratuity/group insurance (f) Commission
The Remuneration 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) and 5(3) of the aforesaid Rules, pertaining to the names and other
particulars of employees is available for inspection at the Registered office of the
Company during business hours and the Annual Report is being sent to the members excluding
this. Any shareholder interested in obtaining a copy of the same may write to the Company
Secretary and Compliance Officer either at the Registered/ Corporate Office address or by
email to secretarial@sunpharma.com.
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 which includes the state of affairs of the Company.
Corporate Governance Report
The Corporate Governance Report and the Certificate from the Auditors
of the Company as stipulated in Schedule V of the Listing Regulations, are provided in a
separate section and forms part of this Report.
Board Meetings
The Board of Directors of the Company met 6 (six) 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 the Corporate Governance Report, which forms a part of this
Report.
Committees of the Board
As on March 31, 2023, 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, 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 are given in Form AOC-2, provided as
‘Annexure – B’ to this Report.
Internal Controls and Internal Financial Controls
The management believes that internal controls are the prerequisite of
governance and that action emanating from agreed business plans should be exercised within
a framework of checks and balances. The management is committed to ensuring adequate
internal controls environment commensurate with the size and complexity of the business,
which assures compliance with internal policies, applicable laws and regulations, ensures
reliability and accuracy of records, promotes operational efficiency, protects resources
and assets, helps to prevent and detect fraud, errors and irregularities and overall
minimises the risks.
The Company has a well-established internal controls framework
comprising a set of policies, procedures and systems, instrumental in enhancing the
efficiency and effectiveness of business operations, reducing risks and costs, and
improving decision-making and accountability.
Internal financial controls framework, sub-set of internal controls
framework assures the reliability and accuracy of financial reporting and the preparation
of financial statements for external purposes following generally accepted accounting
principles.
Whistle-Blower Policy/Vigil Mechanism
As a Company of repute and global standing, Sun Pharma is committed to
conducting its business by adopting the highest standards of professional integrity and
ethical behaviour. The organisation has a detailed Global Code of Conduct
(‘Code’) that directs the Employees to uphold the Company values and urges them
to conduct business with integrity and the highest ethical standards. Management intends
to prevent the occurrence of any practice not in compliance with this Code through the
Global Whistle Blower Policy. This mechanism aims to provide a secure environment to
Employees for responsible reporting of Code violations by Employees. The Board approved
Global Whistle-blower Policy is available on the website, https://sunpharma.com/policies.
Further details on the vigil mechanism of the Company are provided in the Corporate
Governance Report, forming part of this Report.
Global Internal Audit
An independent and empowered Global Internal Audit Function (GIA) at
the corporate level with support from highly skilled and reputed external audit firms,
carries out risk-based internal audits of the Company’s operations, governance, risk
management and internal controls wherever required. GIA audits all businesses &
support functions on a rotation basis to ensure that business process controls are
adequate and functioning effectively. These reviews include financial, operational, and
compliance controls’ design and operating effectiveness and risk mitigation plans.
The GIA department comprises qualified Chartered Accountants, Certified
Internal Auditors, Certified Information System Auditors, Certified Fraud Examiners,
Company Secretaries, MBAs and Engineers. GIA provides assurance and advice to management
on improving the effectiveness and efficiency of the Company’s processes and systems.
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. The Audit Committee of the Board periodically reviews
key findings, provides strategic guidance, and monitors the performance of the GIA
function.
The Company’s operating management closely monitors the internal
control environment and ensures that the audit recommendations are effectively
implemented.
Enterprise Risk Management
The Board of Directors has constituted a Risk Management Committee
which is entrusted with the responsibility of overseeing various organisational risks. The
Corporate Governance Report, which forms part of this Report, contains the details of the
Risk Management Committee of the Company. The Risk Management Committee assesses the
adequacy of mitigation plans to address such risks. The Board approved an overarching Risk
Management Policy. The Policy synopsis is available on the website at
https://sunpharma.com/policies.
The Company has developed and implemented an integrated Enterprise Risk
Management (ERM) Framework through which it identifies, assesses, prioritises, mitigates,
monitors, reports and manages, critical risks impacting its ability to meet its key
strategic and operational objectives. ERM helps to align the risk appetite and strategy of
the organisation, enhance risk response decisions, reduce operational surprises and
losses, and improve stakeholder confidence and trust.
The ERM team engages with all Functional heads/designees to identify
internal and external events that may harm the achievement of the Company’s
objectives and periodically monitors changes in both internal and external environments
leading to a new threat/risk. Risks are categorised into various categories viz.
Financial, Operational, Sectorial, Sustainability, Cyber, Strategic, Compliance, Social,
GeoPolitical, Third-Party etc. These risks are captured in a risk register with all the
relevant information such as risk area, risk description, risk rating, root cause,
mitigation plans, action items etc. The risk register is refreshed periodically.
AUDITORS
Statutory Auditors
S R B C & Co. LLP, Chartered Accountants, (Firm’s Regn. No.
324982E/ E300003), were re-appointed as the Statutory Auditors of the Company for a period
of 5 (five) years at the 30th Annual General Meeting of the Company to hold
office till the conclusion of the 35th Annual General Meeting of the Company.
The Auditor’s Report for the financial year ended March 31, 2023,
has been issued with an unmodified opinion, by the Statutory Auditors. Further, the
Statutory Auditors of the Company have not reported any fraud as specified under Section
143(12) of the Companies Act, 2013.
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, 2023. 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 except a comment, as follows, which, in the
opinion of the Board is self-explanatory.
"We report that the UDIN and date of issue of certificate annexed
in the Annual Report for FY 2021-22, issued under Regulation 34 read with Schedule V, Para
C, Clause 10(i) of SEBI LODR Regulations was incorrectly mentioned. It is clarified that
there is no change in the contents of such certificate and such certificate was without
any qualifications."
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 FY23.
The Company has maintained the Cost Records as specified by the Central
Government under Section 148(1) of the Act.
Business Responsibility & Sustainability Report
The Business Responsibility and Sustainability Report of the Company
for the year ended March 31, 2023, 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.
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 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.
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.
Human Resources
FY23 was an exciting year for everyone. Our 41,000+ strong global
workforce worked relentlessly to ensure medicines continue to reach patients who rely on
us. Driven by Sunology, our employees spread across manufacturing sites, distribution
centres, R&D centres and sales offices worldwide enabled us in delivering a high
performance. The top priority for the Human Resource function is to provide a work
environment which is safe, diverse, inclusive and full of growth opportunities.
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.
There were four complaints received during the year. All the complaints
were disposed of and no complaints were pending as on the end of March 31, 2023.
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.
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 of the Company.
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/annual-return
Secretarial Standards
The Company has complied with the applicable Secretarial Standards as
amended from time to time.
Other Disclosures
There are no proceedings initiated/ pending against your Company under
the Insolvency and Bankruptcy Code, 2016 and there is no instance of one-time settlement
with any Bank or Financial Institution.
Cyber Security Incident
In March 2023, the Company experienced an IT Security Incident that
impacted some of the Company’s IT assets and operations. Based on the Company’s
investigation, the Company currently believes that the incident’s effects on its IT
system include a breach of certain file systems and the theft of Company data and personal
data. A ransomware group has claimed responsibility for this incident. As part of the
Company’s containment and remediation efforts, the Company has taken various
measures, including but not limited to strengthening its cybersecurity infrastructure to
safeguard against such risks in the future. The details on the IT Security Incident are
also provided in Note 55(11) of the standalone financial statements.
Directors’ Responsibility Statement
Pursuant to the requirements under Section 134(5) read with Section
134(3)(c) of the 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, 2023, 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 judgements 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, 2023
and of the profit 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.
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
| Mr. Dilip Shanghvi |
Mr. Sailesh Desai |
| Managing Director |
Whole-time Director |
| (DIN: 00005588) |
(DIN: 00005443) |
| Place: Mumbai |
|
| Date: May 26, 2023 |
|
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 |
Dilip 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 | 2023 |
| Sudhir V Valia | Non-Exec & Non-Independent Dir | 2023 |
| Sailesh T Desai | Whole-time Director | 2023 |
| Gautam Doshi | Non-Exec. & Independent Dir. | 2023 |
| Pawan Goenka | Lead Independent Director | 2023 |
| Rama Bijapurkar | Independent Director | 2023 |
| Anoop Deshpande | Company Sec. & Compli. Officer | 2023 |
| Sanjay K Asher | Independent Director | 2023 |
| Rolf Hoffmann | Independent Director | 2023 |
| Aalok Shanghvi | Whole Time Director | 2023 |
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 |
| NFT50EQWT |
| NFT100LV30 |
| BSE100LTMC |
| NFTYLM250 |
| NFTY100ESG |
| NFTYALV30 |
| NFTYHEALTH |
| NF500M5025 |
| NFTYINDMFG |
| NFTYTOTMKT |
| NMIM503020 |
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 |