Pharma Co's Details.docx

Product Focus: Ajanta Pharma: -

Involved in comprehensive range of specialty drugs in therapeutic segments. Involved in cardiology, dermatology, ophthalmology and pain management. Involved in the generics business Also carrying out R&D

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Company's Institutional business comprises of India Business and Africa Business. In India, company is a reliable supplier for various government bodies like Armed forces, government hospitals, canteens, stores department, etc. The product basket for India market includes multivitamins, antibiotics, eye drops, cough syrups, etc.

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In Africa, Ajanta Pharma was the 1st Generic Company to obtain 'WHO Pre-Qualification' for Anti-Malarial product, a combination of Artemether + Lumefantrine. Company has been innovating on this product since then and has given many new variations for patient convenience and compliance. Currently, company is one of the 6 major players to supply AntiMalarial product to Global Fund.

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In India, we improved our industry ranking by staying ahead in majority of the therapeutic segments of our presence.Our most impressive performance has been in the branded generic segment of emerging markets, where launch of several differentiated products and enhanced marketing efforts have enabled us to achieve stellar growth.

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Enhanced R&D spend to 9% of revenue

Aurobindo Pharma: -

One of the top API manufacturing companies Custom Synthesis that AuroSource which is a custom research and manufacturing division Also involved in Formulations Involved in HIV treatment drugs Involved in Nutraceutical drugs which are used for healthier lifestyle and increase life expectancy Involved in Bio-catalysts Have a research and development in API as well as formuations They have a global presence Highest revenue segment US Formulations

Cadila Healthcare: India:  Amongst top three in the promoted covered market of gynecology, respiratory, pain management, cardiovascular, dermatology and gastrointestinal therapeutic areas  Launched 64 new products including line extensions

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10 first-in-India launches Posted sales of `33,324 million, up 3% on a like-to-like basis; adjusting for GST impact, the growth was 6%

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Launched 20 new products in the US market Posted sales of `58,348 million, up 57% Key launches: o Mesalamine 1.2 g DR tablets (generic version of Lialda®) with 180 days of Exclusivity o Oseltamivir powder for oral suspension 6 mg/ml (generic version of Tamiflu®)

US:

Latin America:  Launched 3 new products in Brazil and 4 in Mexico during the year  Posted sales of `2,605 million, up 7%

Emerging markets  

10 new products launched in markets across Asia Pacific, Africa and Middle East Posted sales of `5,014 million, down 1%

Europe   

7 new products (including 5 from India) launched in France 6 new products (all from India) launched in Spain Posted sales of `2,404 million, down 8%

Specialty Business: APIs: 

Posted sales of `3,656 million, down 4%

CONSUMER WELLNESS    

All three pillar brands, namely SugarFreeTM, EverYuthTM and NutraliteTM registered improvement in growth rates SugarFreeTM maintained leadership position in the artificial sweetener category with a market share of 94.2% EverYuthTM maintained leadership in the peel off mask and scrub categories with market shares of 86% and 33.6%, respectively Posted sales of `4,920 million, up 7% on a like-to-like basis, adjusting for GST impact, the growth in sales was 16%; net profit was at `1,339 million, up 23% from `1,090 million last year

NCE RESEARCH

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Received the marketing approval from the regulatory authority of Mexico, COFEPRIS to commercialise LipaglynTM, a novel PPARα/γ agonist having predominant PPAR alpha activity, in Mexico, for the treatment of Dyslipidemia in patients with diabetes mellitus type 2 and Hypertriglyceridemia in patients with diabetes mellitus type 2 not controlled by statins Initiated Phase II clinical trials in India for investigating ZYAN 1 as a treatment for anaemia associated with chronic kidney disease (CKD) NET PROFIT MARGIN 14.9%

Lupin:  

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India, second-largest market, recorded a strong 11% GST-adjusted growth, APAC grew 13.5% driven by the brands we acquired from Shionogi, EMEA grew 11.2% led by strong performances in Germany and South Africa, and Latin America grew a record 28.1%. Lupin today is the 8th largest generics company by sales globally; the 3rd largest Indian pharmaceutical company by global sales and the 4th largest pharmaceutical player in the US by prescriptions. 5th largest in Indian Pharma market. 2nd highest revenue from new products launched in India in last 2 years. The acquisition of Symbiomix Therapeutics LLC in the US brings a meaningful anchor product, SolosecTM, a truly differentiated product that meets an unmet market need in women’s health. Lapin has built a world class women’s health team in the US to ensure successful execution of SolosecTM. Co. successfully launched Bipresso and entered the CNS specialty market in Japan. In Europe co. filed NaMusclaTM (Mexelitine) for myotonia/neurological disorder with orphan designation and look to commercialize it soon.

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Made strong progress across their complex generics pipeline enabling them to file their first biosimilar application for Etanercept in Japan. Co. also advanced their Inhalation pipeline with successful completion of a Phase 3 trial on Tiotropium DPI. R&D investments is 18.5 billion i.e. 12% of Net Sales. Spread across 9 R&D sites in 6 countries, with over 1,700 scientists and more than 3,000 patents filed globally. Company further diversified their business by investing in meaningful Generic products, Complex Generics and Specialty. Their focus in the near term is to maximize their realization from these investments by delivering on the complex generics pipeline and building their specialty business while gaining cost efficiencies to offset margin pressures. Over the last five years, the Company has made strategic investments in the US-based Research & Development infrastructure and manufacturing facilities. The Research & Development centre for Inhalation, located in Coral Springs, Florida, was established in 2013 and commenced full operations in early 2014. The Somerset, New Jersey-based manufacturing and research operations were acquired in 2016 as part of the GAVIS transaction. This enabled the Company to broaden its pipeline in Controlled Substances, Dermatology, Women’s Health and other niche therapeutic areas In October 2017, Lupin acquired Symbiomix Therapeutics, LLC and its FDA approved brand, SolosecTM. SolosecTM is the first and only approved single-dose oral treatment for Bacterial Vaginosis (BV) – the most prevalent gynaecologic infection in the US, affecting 21 million women between the ages of 14 to 49 annually. The acquisition of the Solosec™ franchise significantly expands Lupin’s Women’s Health specialty business. The Company’s Net Sales for the US in FY2018 experienced a 27% decline from the prior year to close the year at USD 879 million. The Brands business contributed USD 90 million i.e. 10% of the total US sales and grew 16% from the previous year. The Generics business contributed USD 789 million i.e. 90% of the total US revenues which was a decline of 30% from the previous year. The overall decline in US revenues were a result of loss of exclusivity on two key molecules and price erosion coming in the wake of channel consolidation and intensified competition. US Generics LPI is currently the 5th largest Generics company in the US with a 5.3% market share by prescriptions (IQVIA NPA Audit). LPI’s strength in the Generics market is best characterized by its ability to achieve leading market shares. As of March 2018, 51 of the 157 Generic products marketed by LPI in the US were Ranked No. 1 by market share and 109 of the 157 were in the Top 3 by market share (IQVIA Generics Module, March 2018). The Company has leveraged its strengths to focus on increasing its market shares not only via new launches but also through consolidating its position in existing products. Importantly, constantly engaging with trade partners, customers and world-class execution has fortified the Company’s supply chain to ensure industry leading service levels. Lupin’s Brazilian subsidiary, Medquímica was acquired in 2015 for its strong manufacturing platform and its efficient substitution generic commercial structure, with the goal to position Lupin in Brazil. It is the largest Indian company in volumes in Brazil and was ranked 2nd in value amongst its Indian peers in 2017. Medquímica grew 25% in value in FY2018, with sales of BRL 157 million, growing at double the market rate. It launched 11 products and filed 15 products for launch in the coming years. The Company also inaugurated an automated warehouse that doubles its capacity and improves its customer service benchmarks as the Company aims to increase its presence in large pharmacy chains. Mexico is Latin America’s 2nd and the world’s 11th largest pharmaceutical market, valued at USD 11.9 billion as of 2017. The Mexican pharmaceutical market is expected to grow mainly in the

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Antiviral, Diabetes, Oncology and Cardio-Metabolic therapeutic areas with a shift towards greater export diversity. Laboratorios Grin, Lupin’s subsidiary in Mexico, remains one of the key players in the Ophthalmic segment and continues to deliver steady growth. In the past 12 months, revenues grew at 21% year-on-year, with sales of MXP 643 million delivering a healthy increase on all profitability parameters over industry benchmarks. The growth is primarily attributed to our existing Ophthalmic portfolio and new product approvals obtained at the end of FY2017. In addition, new product launches in the area of Glaucoma, not only complemented the portfolio by covering all lines of treatment, but became the first prostaglandin offered in a new preservative-free technology.

Torrent Pharma: -

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Revenue segments: India Business, International Business and US Business Main Product: Therapeutic areas (Diabetory, Cardio Vascular and Central Nervous System) With Unichem's domestic business acquisition, Torrent has entered the list of top pharma firms in the Indian Pharma Market (IPM) and is ranked No 5 in the IMS. Worldwide Presence Torrent has strengthened the US presence through acquisition of Bio-Pharm, Inc. (BPI) a generic pharmaceuticals and OTC Company, based in Levittown Pennsylvania, USA, which includes, its first overseas US FDA registered manufacturing facility. Continuous R&D in all areas. Involved in the full process:

Dr. Reddy’s: -

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They are involved in generics business across the major therapeutic areas of gastrointestinal ailments, cardiovascular disease, pain management, oncology, anti-infective, pediatrics and dermatology. They also produce a few Over the counter products APIs Business Biologics and Biosimilars

Sun Pharma: -

The current financial year is likely to be a very important year in this journey with the potential launch of key specialty products in the US market. R&D investments for the year were `22 Billion, targeted mainly at developing complex generics and specialty products. Continue to be disciplined in identifying future R&D projects for the generics market while simultaneously investing in developing a global specialty portfolio.

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Global Challenges: Ajanta Pharma: -

In the USA, the market environment has been challenging because of pricing pressure due to buyers’ consolidation. Driven by new launches and seamless execution, we have weathered the headwinds satisfactorily which is reflected in our year-on-year growth.

Aurobindo Pharma: -

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Demand Growth & Renewed Investments Encountered hurdles caused by buyer consolidation in the US, and improved pace of USFDA approvals has resulted in rising pricing pressures and increasing competition. In the US pharma market, pricing pressure is fuelled by factors such as increasing competition, payer consolidation and restrictive reimbursement policies. This is further aggravated by cost control tools such as exclusionary formularies and price protection clauses. As a result, the health plan designs are changing and patients may experience a possible increase in both premiums and out-of-pocket payments for their branded medications. The Company’s diversified geographical presence and product portfolio made all the difference in a challenging and competitive market. The pharmaceutical industry is highly competitive, with challenges from both the Indian manufacturers who have similar production facilities as well as those of abroad. Human resources with similar skills, talent, and experiences in the industry are mobile between competing companies.

Cadila Healthcare:  

Drug affordability and accessibility continue to create downward pressure on the market with payers across the globe continuously making all possible attempts to limit prescribing options to drugs. Going forward, however, the global prescription drugs market is expected to grow at a CAGR of over 6% between 2018 and 2024. The growth will be driven by the continued uptake and

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anticipated launch of novel therapies addressing key unmet needs, as well as increasing access to medicines globally. The small molecule brands having sales value of over USD 22 billion lost patent protection in 2017 and over a period of the next 5 years, small molecule brands having sales value of over USD 72 billion are expected to lose patent protection, paving the way for the growth of generic drugs. Apart from small molecules, patent expires of key large biologics brands over next 5 years are also expected to boost growth for biosimilars. This would result in a further shift of prescription share from brands to generics in times to come. Growth of specialty drugs is also expected to outpace the overall market growth rates in the US (Source: Industry Estimates).

Lupin:       

Reported a subdued financial performance, an aberration to our otherwise stellar track record. This was largely due to challenges faced in our US business concomitant to adverse competitive dynamics as well as regulatory hurdles limiting new launches to offset the impact. In the US, SolosecTM’s ramp-up and potential synergistic additions to the Women’s Health franchise would aid predictability and growth of the Specialty business. Co.’s strength in the domestic market and increasing penetration in emerging markets would augment growth, lendingrequisite thrust as co. re-ignite their growth engines. Lupin started FY2018 with headwinds across the global generics industry. The industry as a whole has been under pressure for the last few years but the US generics industry in particular has faced unprecedented pressures that impacted our financial performance. The combination of diversified global footprint and performance in other markets enabled Co. to offset much of the pressures in the US. Despite the market challenges, in-line units grew nearly 6% in the year. The Company launched 22 products in FY2018.

Torrent Pharma: -

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Life sciences sector operates around the issues relating to cost and pricing, clinical and operational innovation, customer and consumer engagement and regulatory compliance and it is expected to have sales growth due to favorable demographic trendsand significant unmet medical needs. While medicine spending is rising, patient out-of-pocket costs for prescription drugs at pharmacies are expected to decline in next 5 years. This is driven by range of factors including that patients receive some form of copay assistance, declining out-of pocket cost due to greater generic availability. The net generic market has seen a de-growth of $5.5 Bn in 2017 from a growth of $5.8 Bn in 2015. The pricing trends for generic medicines have declined on average 6.3%, with significant variation based on the presence of new competition. Recent increases in generic approvals by the FDA and an enhanced competitive environment has resulted in a decline of $5.0 Bn due to associated price reductions. New generics have impacted price competition both directly in the same molecules they compete with and indirectly with others in the same therapy classes, especially when there have been large differences in price. The consolidation amongst the generic purchasers from different class of trade has enhanced the concentration of purchasing

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power and therefore requires the generic manufacturers to maintain their cost competitiveness as well as evolve their product portfolios to less competitive therapeutic areas and dosage forms. Other threats: Drug Price Control, Indian government trying to shift the market towards generic products, new product risk, product liability risks, currency fluctuations risks.

Dr. Reddy’s: -

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continued to witness further consolidation of sales channels, which has given the fewer big US buyers even greater pricing power. The negative price effects of substantial channel consolidation have been further aggravated by intense price competition among multiple suppliers for each generic product. Over the last three years, the average price decline for generic drugs in the USA has not only been high, but has also significantly increased in every passing year. Moreover, growing competition from various international suppliers has made it very difficult, if not impossible, to overcome the price fall by volume increases. These factors are not unique to Dr. Reddy’s. They have negatively affected all major pharmaceutical companies exporting to the USA. Second, we have been affected by regulatory interventions, especially from the USA. As you know, in November, 2015, the USFDA issued a warning letter regarding three plants: an API manufacturing facility at Miryalaguda (Telangana), another API plant at Srikakulam (Andhra Pradesh), and an oncology formulation manufacturing facility at Duvvada, near Visakhapatnam (Andhra Pradesh). In consultation with international experts and the USFDA, your company has continuously worked on instituting corrective and preventive actions across these three sites and has had follow-up meetings with the regulator. The USFDA re-inspected these facilities during February-April, 2017. Based on their observations, further corrective actions were undertaken, and such information was shared with the regulator. Post this inspection, Miryalaguda API manufacturing facility received an EIR indicating closure of the audit. However, for the other two plants, there is no change in status vis-a-vis the USFDA. launches of key molecules, injectables, as well as certain APIs from these sites have been delayed. Although your company has successfully secured regulatory and customer approvals to transfer the production of some of these products to alternative facilities, the outcome has been a significant loss of revenue from the USA for both FY2017 and FY2018. There was also a regulatory hiccup when the Federal Institute for Drugs and Medical Devices (BfArM) of Germany audited your company’s formulation unit 2 (FTO-2) at Bachupally, Hyderabad (Telangana). This resulted in the good manufacturing practices (GMP) compliance certifi cate not being renewed in August, 2017. Corrective work was immediately undertaken. After a follow-up audit, the GMP non-compliance status was withdrawn in January, 2018. However, stoppage in sale to Europe for four months led to lesser revenues. Thankfully, this is over, and we expect to increase sales in FY2019. Moreover, price controls under India’s drug price control orders affected revenue across selected products. As a result, sales performance in India was more muted than it should have been.

Sun Pharma: -

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The other key focus area for company will be cost control and product rationalisation, with these efforts spread across R&D projects, manufacturing footprint and other areas. These steps will ensure that Co. continue to earn reasonable returns on their investments. The short-term outlook for the US generics market continues to be challenging given the pricing pressures. Expect normalisation of the India business in FY19 post the disruption in FY18 due to GST implementation. Favourable demographics will ensure reasonable volume growth in India. However, government-mandated price reductions/policy changes continue to be potential risks for this business. Also expecting reasonable growth in our emerging markets business, however, as always, currency fluctuations continue to be a risk. Given these factors, expect a low double-digit topline growth in consolidated revenues for FY19 over FY18. Consolidated R&D investments for FY19 will be about 8-9% of revenues. In developed markets, ageing population and development of new specialty medicines will continue to drive pharmaceutical growth. In developing nations, growing population and rising disposable incomes among the middle-class, increasing aspirations for better healthcare and gradually increasing penetration of insurance coverage will drive the growth momentum.

Forward Statements: Ajanta Pharma: -

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Currently we have 20 final approved products by US Food and Drug Administration (FDA), which are either commercialized or in process of being commercialized. Additional 4 ANDAs is tentatively approved, and other 15 ANDAs are under review with the US FDA (as on 31st May 2018). We are further planning to file about 10-12 ANDA's every year. With the currency stability expected to continue in key emerging economies, we are confident of further strengthening our market position. However, Africa institutional business saw a degrowth in FY 2018, and impacted the overall growth of the Company. Our focus remains on maintaining a robust product pipeline through increased filing of ANDAs as well as quicker launches. With further thrust on productivity of marketing team, continuous addition of exciting products, sustained investments in R&D and technology excellence in manufacturing, we will continue to remain focused on creating better value for all.

Aurobindo Pharma: -

Our priority is to grow our product portfolio and drive our R&D efforts to create solutions for growing healthcare threats.

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We are investing extensively in our R&D efforts towards creating high-value complex products and drug delivery systems. We are making steady progress in the realms of oncology and hormones including steroids, penems, vaccines, biosimilars, peptides, dermatology and respiratory. We remain optimistic about our growth across geographies; and aim to further de-risk our business by extending our product portfolio. The rapid pace at which our new initiatives are moving across the development and regulatory approval stages, we are confident of their successful commercialization in the foreseeable future. We strongly believe that, these products will ensure long-term growth of the Company and significant value creation for all our stakeholders. Future drivers of global pharma growth are gene therapies, digital health and specialty medicines.

Cadila Healthcare: US:      

Filed 26 Abbreviated New Drug Applications (ANDAs) with the USFDA 330 cumulative ANDA filings First-ever ANDA submitted from the injectable manufacturing facility of Liva Pharmaceuticals Limited near Baroda 77 ANDA approvals (including eight tentative approvals) Highest number of ANDA approvals in a financial year 186 cumulative ANDA approvals

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In Brazil, filed 3 new product dossiers and received approval of 1 new product from the regulatory authority ANVISA during the year In Mexico, filed 2 new product dossiers and received approval of 3 new products from the regulatory authority COFEPRIS during the year

SPECIALTY BUSINESS US 

Moved a step further to build thespecialty business in the US asthe USFDA granted the approvalfor pitavastatin magnesiumtablets, the first product filedthrough 505(b)(2) route, whichwas recently launched in the USas ZypitamagTM

APIs 

Filed 6 DMFs with the USFDA,taking the cumulative US DMFfilings to 133.

BIOLOGICS

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Completed Phase III clinicaltrials in India and receivedmarketing authorisation fromDrug Controller General of India(DCGI) for one more monoclonalantibody, viz. Bevacizumab.Subsequently, the product waslaunched in India under thebrand name BryxtaTM  Received marketing authorisationfrom DCGI for 2 more productsviz. Follitropin alpha andPegasparagase during the year  On the emerging markets front,received 5 product registrationsin different countries of emergingmarkets. Launched 2 biosimilarsviz. ‘Colstim’ (biosimilar of filgrastim) and ‘Pegstim’ (biosimilar of pegylated filgrastim) in the emerging markets of Philippines and Sri Lanka, respectively  On the novel biologics front, initiated Phase III clinical trials in India for RabimabsTM VACCINES 

Successfully completed Phase III clinical trials in India for 1 more vaccine and applied for Marketing Authorisation to DCGI ANIMAL HEALTH   

Commenced export of products from India to four new countries during the year Sold the entire stake in Bremer Pharma GmBH, Germany, in April 2018 Posted sales of `4,426 million, up 11% on a like-to-like basis; adjusting for GST impact, the growth in sales was 14%

Lupin: 

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The Company filed 36 ANDAs {(26 Orals, 4 Injectables, 2 Dermatology, 2 Ophthalmic and 2 Inhalation), including 2 confirmed exclusive First-to-file (FTF), 6 shared FTFs and 2 First-to-market (FTM) opportunities with US FDA. During the year, Lupin received 24 ANDA approvals from the US FDA} in the US market during FY2018 and currently has 163 ANDAs pending approval, addressing a total market size of over USD 60 billion. Lupin’s first-to-file ANDAs pending launch stand at 36, including 15 exclusive first-to-file ANDAs targeting a market size of more than USD 2 billion. Company is committed to re-establishing the Branded business as a growth driver for the coming years. Keeping the long-term vision and cost competitiveness in mind, Lupin continue to invest judiciously in creating new manufacturing facilities as well as augmenting existing manufacturing facilities globally to aid effciencies as well as build capacities to meet future demand. Lupin plan to augment biosimilar capacities in line with our commercialization plans. The company also remains committed to invest in technology, automation to improve compliance and safe-guard intellectual property. The company invested 10,470 million for capital investment during FY2018. Step to enter the Biosimilars space in Japan, which we believe is expected to grow substantially in the years to come.

Torrent Pharma: -

Us Business: The company currently has 65 ANDA approvals with 28 approvals in pipeline. We also have 150 products under development. We aim to strengthen our position in the market by launching Ointments, Injectable and Specialty Oral Solids (Oncology) in the coming times.

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Bio-Pharm Inc.: To date, BPI has 10 approved ANDAs, 10 ANDAs under review at the FDA for itself and its partners and has an additional 17 products under development. Torrent’s major pharma markets are India, US, Germany and Brazil. The Company’s strategic priorities in India and Brazil remains continuous focus on specialties, field force productivity and new product development. These markets remain a key priority for the Company and such markets offer higher visibility and sustainability to the business. In US and Germany, the Company focuses on strengthening new product pipeline through product innovation and developing complex products.

Dr. Reddy’s: -

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In FY2018, we fi led 19 new abbreviated new drug applications (ANDAs) and one new drug application (NDA) under 505(b)(2) route with the USFDA. As of 31 March 2018, we had 110 generic fi lings pending approval from the USFDA, comprising 107 ANDAs and three new drug applications (NDAs) fi led under the 505(b)(2) route of the US Federal Food, Drug and Cosmetic Act. Of these 107 ANDAs, 63 are Para IV applications — of which we believe 30 have ‘First to File’ status. We have significantly enhanced quality management systems and operations,which include improvements in rigor of investigations and document control systems, standardization of instrument calibrations, strengthening shop-floor level IT controls as well as shop floor training programs, and simplifying and standardizing standard operating procedures and batch records. There exist significant opportunities in Emerging Markets, which are now on a longer-term upswing. We should be able to increase revenues from these geographies through greater sales of simple and complex generics as well as hospital and institutional sales of oncological biosimilars. There are also major prospects in key emerging markets for speciality generics and biosimilars, and your company will be doing its utmost to increase its market presence in these countries. We expect the business to now generate double-digit growth, as it has in the past, and it surely can.

Sun Pharma:    

Given the shifting dynamics of the global pharmaceutical market, progressive investments in innovative specialty products show the way forward for us. At Sun Pharma, have identified specialty as an additional growth engine; and a means to move up the pharmaceutical value chain through development and global commercialisation of branded patented products. Have invested significant resources in this initiative in the past; and will continue to invest in building the business further in the coming years. Co. is meticulously nurturing the specialty business; and have built a portfolio of about 10 specialty products, of which five are already in the market, two more likely to be commercialised in the next few quarters; and two more awaiting USFDA approval.

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Co. is reinforcing our global specialty business with focused investments and strategies; and in the long-term, we expect the contribution of specialty products to increase substantially in overall business. Also investing in enhancing product pipeline for emerging markets and other non-US developed markets. Specialty portfolio targets Dermatology, Ophthalmic, Oncology and CNS segments. Developing specialty products pipeline with a focus on improving patient outcomes either by addressing unmet medical needs or by enhancing patient convenience through differentiated dosage forms. Filed two of our important products – Ilumya (Tildrakizumab) and OTX-101 with the USFDA and also received final approval for Ilumya in the US The USFDA approved Biologics Licence Application (BLA) for Ilumya in March 2018. New Drug Application (NDA) for OTX-101 was accepted by USFDA in December 2017 Announced USFDA approval for Yonsa® (abiraterone acetate), received approval from the USFDA for a new label for Odomzo® (sonidegib), recently initiated investments in the development of two new indications for Ilumya, viz., psoriatic arthritis and ankylosing spondylitis The clearance of the Halol facility by the USFDA paves the way for potential approvals for Elepsia XR (Levetiracetam Extended Release tablets) and Xelpros (Latanoprost BAK-free eye drops). Co. is gradually ramping up global specialty business. Planned to increase its contribution to our consolidated revenues in the long term. Some of key specialty products are likely to be commercialised in the US in FY19 and hence expect to incur significant pre-launch and branding costs along with increasing sales force costs. The US generics industry continues to face pricing pressure driven by increasing competitive intensity and customer consolidation. Despite these adverse dynamics, the Company expects low double digit growth in consolidated revenues for FY19. Sun Pharma continues to invest in enhancing its global specialty and complex generics pipeline. Investments will also continue for setting up the requisite front-end capabilities for the specialty business in the US as well as on clinical trials for some of the specialty products. These investments may not have commensurate revenues in FY19 but are likely to drive growth in the longer-term. The consolidated R&D investments for FY19 will be about 8-9% of consolidated revenues. The Company expects a gradually increasing tax rate over the next few years.