After contracting by 3.1% in 2020, the global economy is estimated to have expanded by 6.1%1 in 2021, the highest rate of growth in more than four decades. The global recovery was largely driven by robust consumer spending and rebound in investment supported by easing of COVID-19 restrictions, large fiscal stimulus packages and supportive monetary policies. Manufacturing activity picked up on the back of increase in demand and global trade in goods bounced back to pre-pandemic level. However, growth momentum slowed towards the end of the year on the back of disruption caused by Omicron variant, inflationary pressures due to the emergence of supply side challenges amid a robust demand environment and signalling of policy tightening by central banks.
After a strong recovery in 2021, the growth momentum is likely to moderate to 3.6%1 in 2022 due to tighter monetary policies and ongoing geopolitical tension between Russia and Ukraine which has exacerbated inflation and supply chain issues and dampened growth prospects. Rising inflation is likely to result in further tightening by central banks across the world thus limiting borrowing and constraining fiscal space. Given that the recovery is still fragile and uneven, policymakers find themselves in a situation where they need to calibrate and coordinate their policies to manage trade-off between growth and inflation. As financial conditions tighten and fiscal support is withdrawn, investment growth is likely to moderate. Ongoing geopolitical tensions, supply chain issues and quickening pace of monetary policy normalisation to tame inflation continues to cast a shadow of uncertainty on growth outlook.
The Indian economy grew by 8.7% in FY22 regaining its position as the worlds fastest growing major economy on the back of strong rebound in manufacturing, agriculture, mining, and construction sector. Business and consumer confidence improved on the back of easing of restrictions, increasing rate of vaccination and improving demand conditions. Moreover, the central bank maintained an accommodative stance and kept lending rates unchanged to spur growth.
Also, the Government announced massive capex spending to support the economic growth. However, rising inflation, supply chain issues and soaring oil prices led to decline in growth momentum towards the end of the fiscal year. Ongoing geopolitical tension could further aggravate the supply chain issues and stoke inflationary pressures which is likely to result in phased withdrawal of liquidity and beginning of monetary policy tightening thus dampening growth prospects.
According to IMF estimates, the Indian economy is expected to grow by 8.2%1 in FY23 on the back of uptick in domestic demand conditions and pick up in credit cycle. However, high commodity prices and global supply bottlenecks is likely to impact the manufacturing sector and overall growth prospects. Moreover, capital outflows and rising import bills could lead to widening of current account deficit putting pressure on the rupee. Nevertheless, favourable government policies such as production-linked incentives and increased infrastructure spending is likely to lead to strong multiplier effect and lead to sustained economic growth. Also, the geopolitical conflicts could establish India as a preferred alternate investment destination.
GLOBAL PHARMA SECTOR
The pharma market is changing in response to the rapidly evolving expectations of customers and investors. The global medicine market is expected to reach about $1.8 trillion in total market size by 2026. Spending on COVID-19 vaccines and novel therapeutics are expected to generate more than $300 billion in spending till 2026. Global spending on medicines continues to be driven by innovation and offset by losses of exclusivity and the lower costs of generics and biosimilars. New brand spending in developed markets is likely to push spending driven by high number of new drugs. Going forward, specialty medicines is likely to dominate overall spending globally while the older and traditional therapies will become progressively lower cost over time.
The two leading global therapy areas-oncology and immunology are forecast to grow at a CAGR of between 9-12% and 6-9% respectively through 2026 on the back of increase in new treatments and medicine use. Oncology is projected to add 100 new treatments over five years, contributing nearly $120 billion in new spending and bringing the total market to more than $300 billion in 2026. In the last five years, a new wave of rare disease neurological treatments, including dozens with orphan designations, have been approved, and others with larger populations, such as migraine, depression, and anxiety, have also seen a range of new treatments. Recent scientific advances in genomics, biomarkers, diagnostics, and imaging techniques and/or regenerative medicine, combined with the emergence of disruptive digital technologies are also changing the fundamentals of innovation in mental health disorders.
GLOBAL ONCOLOGY MARKET
Global oncology spending is expected to grow at a rate of 9-12% and exceed $300 billion by 2026 on the back of continued incidence of cancer, early diagnosis of patients, tremendous focus on discovering and developing new therapies and medicines for cancer treatment and wider access to novel cancer drugs/treatments across geographies. In the U.S., much of the growth in spending has been from the growing use of PD-1/PD-L1 drugs as well as a proliferation of mechanisms for small molecule and antibody-targeted agents. Of the cancer types accounting for the majority of spending in developed countries, kidney cancer, non-small cell lung cancer, chronic lymphocytic leukaemia, melanoma, and multiple myeloma saw 20% or more increases in annual spending since 2017, reflecting new treatment options with new mechanisms, improved diagnosis rates and longer treatment durations. Oral and subcutaneous oncology treatments have been growing faster than IV/infused, especially since COVID-19.
There have been tremendous advancements in the field of oncology over the last two decades, resulting in improved quality of life and survival rates. Many innovative therapies have been launched and pharmaceutical companies continue to invest significantly in oncology research to advance the cancer treatment market. The focus of cancer treatment is rapidly shifting from a traditional one-size-fits-all approach to precision medicine, tailored treatments for individual patients. The current oncology pipeline is expected to add more than 100 new drugs in the next five years, which includes innovative treatment through cell therapy, RNA therapy, and immuno- oncology treatments including those that are mutation-specific and thus tumour-agnostic.
In the U.S. there were 62 unique new cancer medicines launched in the past 5 years with many approved for more than one indication. In 2020, the EMA has approved twice as many NASs in oncology compared to last year, half for rare cancers.
A total of 64 oncology new active substances have launched globally in the past five years, bringing the 20-year total to 161.
GLOBAL PRESCRIPTION DRUG SALES
According to a report by Acumen Research and Consulting, the Global Prescription Drugs Market is expected to grow at a CAGR of around 8.9% from 2020 to 2027 and reach a market value of over $1.6 trillion by 2027. The growth is expected to be led by rising awareness of chronic and serious disorder among individuals, rise in launch of generic equivalent of several drugs across major key markets along with rising healthcare expenditure.
In developed countries, the adoption of new treatments, offset by patent lifecycles and competition from generics and biosimilars, are expected to continue as the main factors influencing medicine spending and growth. Pharmerging and lower income countries spending and usage of medicines is focused more on older traditional therapies, while developed countries spending is growing on newer specialty therapies despite continued high use in older therapies.
REGIONAL PRESCRIPTION DRUG SALES- DEVELOPED MARKETS
United States of America
Prescription drugs have become an increasingly important part of U.S. health care. Spending on medicines increased by 12% to $407 billion in 2021 due to the availability and uptake of COVID-19 vaccines and therapeutics. Per capita use of prescription drugs has increased over the years led by increase in the availability and use of different types of new drug therapies. Drug prices in the United States are much higher than they are in peer nations due to government-granted exclusivity periods, the industrys success at extending these periods, and the inability of most public payers to meaningfully negotiate prices. Specialty medicines now account for 55% of total spending, up from 28% a decade ago and largely driven by growth in autoimmune and oncology treatments.
Over the next five years, more than 250 new drugs are expected to be launched in the U.S. and contribute over $100 billion in new spending. Immunology, oncology, and neurology will drive the growth in spending predominantly from introduction of new medicines.
Medicine spending in the top five European markets is expected to increase by $51 billion over the next five years, up from $44 billion in the past five years. Spending in Europe is expected to increase driven by a focus on generics and biosimilars, increasing healthcare expenditure, and a surge in R&D investments. New brands were the largest driver of growth from 2016 to 2021 and are expected to continue in the next five years but will be hampered by lingering effects of the pandemic. Generics, including biosimilars, are expected to add $15 billion in growth over the next five years.
Supportive regulatory framework and reimbursement policies have helped accelerate the adoption of pharmaceuticals. However, reimbursement scenario is highly variable across Europe for generic medicines which has resulted in uneven penetration for different countries. The branded segment accounts for the largest revenue share led by increasing R&D efforts, the growing adoption of novel therapies, and strategic collaborations. Strong pipeline products in different therapeutic areas are likely to boost the growth of branded drugs in Europe.
The global pharmaceutical contract research and manufacturing (CRAM) market is expected to clock 6.2% CAGR over CY21-26E to touch ~$170 billion5 driven by the availability of highly skilled and cost-efficient resources in emerging markets and the growing need to focus on core competencies. Over the years, focus of pharma companies has shifted towards increased R&D and production of patented drugs as these drugs provide exclusive marketable rights leading to better margins. However, since most of them do not have the required expertise and capital to undertake R&D activities for newer drug discovery & manufacturing, there has been an increasing trend in terms of outsourcing R&D, drug discovery, manufacturing and commercialisation to companies having the required core capabilities. North America and Europe are the major markets for contract development and manufacturing organization (CDMO) and account for ~70% of the outsourcing in global Formulations.
The global Biologics CDMO market is expected to clock 11% CAGR over CY20-26E and reach $19 billion5. The growth is likely to be driven by increasing number of products under development for targeted action by small and emerging pharma companies having minimal manufacturing capabilities. The complexity of the biopharmaceuticals and the highly personalized medical therapies and devices drive the increased complexity in the supply chain operations and lead to increasing reliance on contract manufacturing. As global pharma companies continue to increasingly focus on biologics R&D, they have started outsourcing small- molecule manufacturing. The drug development process in emerging economies is undergoing significant technological advancements resulting in accelerated pace of outsourcing of research and manufacturing operations of various drugs from developed countries.
INDIAN CRAMS INDUSTRY
Key Trends & Opportunities
The Indian CRAMS industry grew at a CAGR of 14%6 from FY16 to FY21 and is pegged at $13.6 billion and is expected to clock 14-16%6 CAGR between FY21-26E. Increasing number of pharma companies are finding it profitable to outsource all aspects from R&D to commercialisation to trusted partners in countries with strong research capabilities and optimal cost. COVID outbreak and China+1 strategy being pursued by global MNCs has only affirmed the position of India as the most preferred location for outsourcing R&D and manufacturing due to its proven track record of high-quality research capabilities coupled with competitive cost structure. CRAMS players in India offer end-to-end services, right from pre-clinical trials to manufacturing finished dosages. Moreover, India offers multifarious heterogeneity in its population and an enormous patient & genetic pool, which is required for testing the veracity of drugs during clinical trials.
Indian companies continue to build their skillset to cater to biologics and Synthesis-based CDMO as there is huge product pipeline looking for competent manufacturing partners. Indian CRAMS companies hold a competitive edge across the global pharmaceutical industry in being the most preferred partners for drug development and manufacturing. Owing to a wide- ranging product mix consisting of high-end research services, biologics, and complex technology services, CRAMS industry has witnessed tremendous growth in the country.
INDIAN PHARMA - GROWTH OUTLOOK 7
India is the generic pharma factory of the world and ranks third in terms of volume and thirteenth in terms of value with a market size of around $45 billion in FY21. Generic drugs demand is increasing across the world driven by aging populations, increasing incidence of lifestyle disease and growing trend of substituting expensive patented drugs with cheaper generic drugs. India is also emerging as a significant supplier of biosimilars such as insulins, therapeutic antibodies, etc. The Indian Pharmas export competitiveness is underlined by the presence of strong chemical industry, skilled workforce, and high-quality manufacturing standards. Key growth drivers for the industry are opportunities arising due to expiry of patent drugs across the globe, government support to de- risk dependency on China, increase in penetration of health insurance, improved access, and surge in lifestyle diseases.
The production linked incentive (PLI) schemes announced by the Government for key raw materials such as bulk drugs and formulations is likely to reduce import dependence and boost domestic production of high value products thereby increasing the value addition in exports. Moreover, to ensure infrastructure assistance to the API players, the Government announced the promotion of bulk drug parks scheme. All these measures will strengthen the R&D efforts of Indian pharmaceutical companies and result in production of high-value-added pharmaceutical products. Indian API companies have been the biggest beneficiary due to the pandemic led supply chain disruption and the recent anti-China sentiment and stand to gain significant market share in the years to come. There has been increasing trend of backward integration in the industry for input materials thereby reducing import dependence. New opportunities have emerged due to these external factors and there exists significant opportunity to expand global market share in key therapies like Oncology, CNS, Diabetes, Cardio, Peptide, etc.
There exist immense growth opportunities for the Indian Pharma player as they endeavour to move up in the value chain towards New Chemical Entity (NCE), biosimilars and specialty drugs. Favourable government policies encouraging backward integration, China+1 strategy for supplier diversification, along with investment from PE players augurs well for the growth of the industry.
DRUG DISCOVERY - EMERGING TRENDS
The Covid-19 pandemic has led to a paradigm shift in terms of adoption of technologies such as Artificial Intelligence (AI), natural language processing (NLP) and advanced imaging analytics by the pharma industry. Digital companion tool is likely to be employed increasingly to capture data on drugs efficacy, safety, adherence, and engagement along with precision dosing for specialty drugs to close the real-world data gap and help develop more precise dosing recommendations for novel therapeutics. Dynamic trial designs that give patients an ever- growing number of methods to participate in studies from home will likely be the way forward to engage with patients. Several techniques like RNA and nanotechnology interference are also being used for drug discovery.
ABOUT DISHMAN CARBOGEN AMCIS LIMITED
The Dishman Group is a global and integrated CRAMS player with strong capabilities across the value chain - from research and development, to late stage clinical and commercial manufacturing. Dishman Carbogen Amcis Limited, the flagship company, includes its Indian and foreign subsidiaries, joint ventures, and associate companies across the globe.
We are the preferred global outsourcing partner present across multiple continents and countries, including the United States, Switzerland, UK, France, Netherlands, China, Japan, and India. We service customers from all the key advanced markets including US, Europe, and Asia.
We are equipped with strong chemistry skills and large-scale multi- purpose manufacturing capacities. We have a wide range of research competencies and 10 manufacturing capacities and a global presence with manufacturing sites in Europe, India, and China. Of these, 4 are in Switzerland; 2 in India; and one each in UK, France, Netherlands, and China. Our HiPo facility at Bavla, India is one of the largest facilities in Asia, which enables us to gain from the high margin HiPo opportunity in the oncology space and other highly potent compounds.
Although we started as a manufacturer of quaternary ammonium and phosphate compounds, we became one of the fastest-expanding companies in the CRAMS space in India in a short span of time. We ventured into the CRAMS business with a contract to develop and manufacture an Active Pharmaceutical Ingredient for the innovator. We were one of the first companies in India to bring a new chemical entity into India for successful development and commercial manufacturing. Since then, we have entered into multiple contracts with innovator companies. Our growth by way of acquisitions and greenfield projects over the last 14 years has yielded us rich dividends in terms of the exceptional talent pool and unparalleled operational excellence.
OUR KEY SEGMENTS
Our key segments include CRAMS (Contract Research and Manufacturing Services) and Marketable Molecules.
The CRAMs segment is further broken down into Contract Research Services and Contract Manufacturing Services, which we offer to our customers.
OUR BUSINESS VERTICALS
1. CONTRACT RESEARCH AND MANUFACTURING SERVICES (CRAMS)
Our principal line of business is Contract Research and Manufacturing Services (CRAMS). We are an integrated CRAMS player with strong capabilities across the value chain. Through our CRAMS business, we assist drug innovators in development and optimisation of processes for novel drug molecules in various stages of the development process.
Once the innovative molecules are approved, this segment explores the possibility of possible largescale commercial supply tie-ups. We provide end-to-end high-value CRAMS offerings right from process research and development to late- stage clinical and commercial manufacturing. CRAMS segment contributes nearly 75% to our total revenues. Given our vast experience and highend capabilities, we are comfortably placed to reap the benefits of strong growth and emerging opportunities in the global CRAMS industry.
A. CARBOGEN AMCIS
CARBOGEN AMCIS is a specialized service provider offering a portfolio of drug development and commercialisation services to the pharmaceutical and biopharmaceutical industries at all stages of drug development. Our integrated and tailored services for Drug Substances (DS) and Drug Products (DP) provide innovative solutions to support timely and safe drug development. We perform our custom synthesis operations within the Dishman group which includes two facilities in India and in CARBOGEN AMCIS group with eight facilities which includes four in Switzerland, one in UK, one in China, one in France and one in Netherlands.
CARBOGEN AMCIS provides services for the development and manufacturing of both nonpotent and highly potent drug substances (APIs) and drug products applying state-of-the-art containment technologies. All facilities operate under current Good Manufacturing Practices (cGMP) and can produce material for preclinical testing, clinical trials, and commercial use. Our manufacturing sites are regularly inspected by the US Food and Drug Administration (FDA) and local regulatory authorities. The large-scale production capacities (up to 8,000 L) allow the efficient production of non-GMP intermediates that can be further processed at the CARBOGEN AMCIS Swiss facilities.
Our well-equipped facilities in Riom (France) offers aseptic cGMP manufacturing for liquid or freeze-dried products including drug delivery, highly potent and antibody drug conjugates (ADC). A wide range of filling volumes and packaging components (vials or syringes) are applied to support pre-clinical and clinical studies all over the world. Formulation, process development and upscaling services for liquid and frozen-dried products are also part of our service offering.
We have successfully completed numerous drug linker projects. Since the first ADC project in 2005, many customers, ranging from small biotech to large pharmaceutical companies, expressed growing interest in our ADC and bioconjugation abilities. We have handled projects ranging from payload/ warhead manufacturing to drug-linker, then to conjugation and final drug product all inhouse. Our clean room suites are fully qualified for cGMP manufacturing dedicated to bio conjugation. This is in conjunction with our state-of-the-art purification technologies and exceptional analytical/fill-and finish capabilities.
B. Dishman India
Dishman India is a global outsourcing partner for the pharmaceutical industry offering a portfolio of development, scale-up and manufacturing services. Dishman assists and empowers its customers businesses by providing a range of development and manufacturing solutions at locations in Europe and India. Our commitment is to deliver high added value solutions with technical excellence and to be a reliable partner to our customers, protecting their interests as if they were our own.
Dishman offers specialised research and development services i n developi ng processes that are truly scalable through to commercialisation, be it through process research, process development or optimisation. We have a dedicated pool of highly skilled staff operating in three continuous shifts on a daily basis in stateof-the-art R&D centres. Our promise is safe, efficient scale-up and problem solving delivering robust, economic processes. Dishman enforces strict IP protection policies. We protect our customers interests as if they were our own.
2. MARKETABLE MOLECULES
A. Specialty Chemicals
Dishman Specialty Chemicals manufactures and supplies high- quality intermediates, fine chemicals, and various products for pharmaceutical, cosmetic and related industries. The Company had a long association with the manufacture and supply of Quaternary ammonium compounds (Quats) for use as phase transfer catalysts. Our domain expertise in solids handling technology has helped us to expand our offerings to include ammonium and phosphonium high-purity solid Quats, Phosphoranes and Wittig reagents.
These products find applications as phase transfer catalysts, personal care ingredients, fine chemicals, pharma intermediates and disinfectants. A number of our products are made under GMP manufacturing conditions at our Naroda facility in India. Furthermore, we maintain local stocks of select products in Europe and in the US.
We have significant expertise in providing tailor made solutions. We are well equipped to supply our customers with our quality products or provide them assistance on the next project with our world class manufacturing expertise, logistics and competitive pricing.
B. Vitamins and Analogues
Vitamin D plays a vital role in brain development, muscle function, maintaining a healthy respiratory and immune system, and optimal cardiac function. It also strengthens our bodies against illnesses such as diabetes, asthma, chronic pains, cancer, infections, multiple sclerosis, psoriasis, depression, etc. However, if there is a Vitamin D deficiency, then it leads to bone disorders such as rickets, osteomalacia and osteoporosis.
Vitamin D is present in inactive form in the human body and gets activated in the presence of sunlight to process the release of Calcifediol. This Calcifediol is then metabolised in the kidney to release Calcitriol which is further absorbed by the intestine, kidney and bones. The bones mobilise the secretion of Calcium and Phosphate in the parathyroid gland to maintain the optimum balance of these elements which is a prerequisite for strong bones.
Functioning as the global outsourcing partner for other pharmaceutical companies; aiding them in development and scale-up production via its high potency supply of compounds; Dishman first realized the need of the hour with Vitamin D because of its elaborate research on its therapeutic uses that covers wide range of medical conditions. Keeping wellness as our primary objective, we acquired Solvay Pharmaceuticals Veenendaal, Netherlands plant which focused on manufacturing cholesterol, serving as a precursor to vitamin D & its analogues.
As a multifaceted organisation with a high degree groundwork, we established greener processes to manufacture in a budgeted environment. Hence, we ensure the extraction of this cholesterol from sheep wool, making it a vegan source required to form a strong base for the formulations. Gradually, with a steadfast strategy, entrepreneurial spirit and a rising demand for the application of this raw material in various sectors: as a natural course towards the extension of existing and acquired business, we forayed into developing a wide spectrum of products for the pharmaceutical, nutraceutical and holistic animal nutrition verticals of Vitamin D3. This derivative if taken in the right quantity, can cure to the roots of many diseases, resulting in complete wellbeing.
In the pursuit of developing a world-wide circuit in the supply of Vitamins and its analogues, Dishman has completed the establishment of WHOcGMP compliant fully integrated manufacturing unit, at Bavla, based in Gujarat, India, which is also an ISO 9001:2015 certified. Its core lies in its CRAMs model capabilities that umbrellas an entire gamut of services from production of raw materials to developing the final products as well as market the same. This has enabled us to be in the forefront with the capacity to manufacture 1,000 MT annually and simultaneously catering to specifically engineered requirements of our clients, all at one place.
Dishman Care has a range of hand and body wash, sanitisers, and antiseptics, apart from its active pharmaceutical ingredients and formulations businesses. We offer a range of antiseptics and disinfectants for application in healthcare and related industries. Our aim is to build a deep portfolio of next generation innovative antiseptic and disinfectant formulations. Our product pipeline specialises in high quality, cost effective, proven antimicrobial products based on Chlorhexidine Gluconate (CHG) and Octenidine dihydrochloride (OCT). We shall provide specialist products for environmental decontamination based on hydrogen peroxide disinfectant.
D. Generic APIs
Dishman plans to develop and manufacture niche generic APIs. The Company is working on development of certain generic molecules, which could have huge potential in terms of profitability. We are working towards capturing a larger market share of the profitable generic APIs such as imaging reagents where we have filed the Drug Master Filings or other regulatory filings. The Company will continue to file for such molecules in the future as well and strive to increase the proportion of these molecules in the marketable molecules business segment.
OUR COMPETITIVE STRENGTHS
A. CAPABILITIES ACROSS THE ENTIRE CRAMS VALUE CHAIN
Today, the Dishman brand is perceived by global customers as a preferred global outsourcing partner with capabilities across the entire CRAMS value chain, with services ranging from process R&D and pilot supply, to full scale and commercial manufacturing from purpose built and dedicated facilities. The Groups India and Chinese facilities possess strong chemistry skill sets: a large dedicated multiple shift R&D operation; and 25 dedicated production facilities for APIs, intermediates (India, China) with dedicated API manufacturing capacity at India and China.
OUR PRESENCE ALONG THE VALUE CHAIN
B. HIGH POTENCY API CAPABILITY
The Dishman Group has invested in world class capabilities to address the oncology and other highly potent compound therapy markets. Coupled with 15 years of HiPo API experience, the High Potency API business represents a significant opportunity for step change in the Groups topline and bottom-line growth. The Group has a strongly differentiated set of capabilities in the HiPo API arena with pre-clinical API, phase 1/phase 2/phase 3 and commercial API and up to clinical Ph2 parenteral dosage form capabilities. All these capabilities remain in house and underwritten by a consolidated project management capability to take customers from pre-clinical stages through to commercial manufacturing of APIs, right through to formulated products.
C. SCIENTIFIC ADVANCEMENTS
Successful drug development is a balance between speed, quality and costs. We aim to offer our customers a choice of state-of-the-art tools combined with qualified and experienced staff to best meet these often-changing priorities. CARBOGEN AMCIS has built up a portfolio of specialist services to give customers the highest degree of flexibility possible.
Chromatography often forms part of a fast route to producing initial quantities of material. We offer customised chromatography solutions for the separation and purification of APIs and intermediates, including highly active APIs and impurity isolation. Our dedicated group of chemists have more than 50 years experience in the group expertise in method development and scale-up in a variety of different chromatographic techniques, all in accordance with current Good Manufacturing Practice (cGMP) environment. Cost-effective largescale chromatography is also possible given the correct infrastructure. CARBOGEN AMCIS offers Flash Chromatography (Biotage), SMB and HPLC to effectively produce clinical trial quantities of APIs and commercial products.
Defining the best crystalline form of an Active Pharmaceutical Ingredient (API) is crucial in drug development, since it has a significant impact on its bioavailability and formulation properties. CARBOGEN AMCIS has established a service supporting our customers with crystallisation investigations including solubility tests, salt screening, and optimisation of the crystallisation process and the solid/liquid separation in the API isolation process. Polymorphism screening complements the service portfolio. We offer online monitoring of critical parameters such as particle size, turbidity, temperature, and pH value, as well as analytical services dedicated to solid phase characterisation including hot stage microscopy, differential scanning calorimetry, Dynamic Vapor Sorption (DVS) and x-ray powder diffraction.
D. WORLD CLASS MANUFACTURING FACILITIES
Our state-of-the-art infrastructure includes process research and development (PR&D) laboratories and, one laboratory dedicated to conjugation of small and large molecules and manufacturing capabilities. CARBOGEN AMCIS delivers leading process research services that support the drug development process. Early Active Pharmaceutical Ingredient (API) manufacture centres on the rapid synthesis of supplies necessary to perform both toxicology and early phase clinical trials. Typical batch sizes here range from 1 gram to 50 kg scale and are prepared as per the highest standard of current Good Manufacturing Practices (cGMP).
We internally optimise each site with all the equipment necessary to help your project to become a success. We provide unparalleled analytical support for research, development and commercial production of late stage intermediates and APIs, including pre-formulation studies to support drug product development. In addition to pre-formulation services, solid state and crystallisation services, and analytical support for physicochemical characterisation and method validation, CARBOGEN AMCIS offers a complete range of drug product development and manufacturing services at our Riom site in France. Our specialty is the injectable space and the handling of complex compounds such as highly potent APIs, biological products and drug delivery. This site is exclusively dedicated to the development and the cGMP manufacturing to the fast supply of batches for clinical studies.
CARBOGEN AMCIS utilises the Shanghai manufacturing facility for manufacturing the intermediates for the final API, which gets manufactured in the Swiss facility. This facility is also cGMP approved and the plan is to make it equipped to manufacture the final API as well, which would act as a good alternate manufacturing site for the APIs manufacturing. CARBOGEN AMCIS utilises its UK facility as the one for manufacturing non-GMP intermediates and starting material, which again feeds into the Swiss facility for manufacturing the final API or gets shipped to the customer. Dishman Carbogen Amcis facilities in India equips the Group with large-scale development and manufacturing capabilities, which ensures that the customer does not have to move outside the Dishman Group to get the large volume products developed and manufactured. Thus, the group acts like a one-stop shop for the development and manufacturing of APIs for all types of molecules. Moreover, the HiPo capabilities are unique to the group and differentiates it from its peers.
KEY HIGHLIGHTS - FY22 & OUTLOOK
The Company delivered healthy performance in the year ended March 31, 2022 despite challenging economic environment and EDQM related issues. Revenue for the Company on a consolidated basis stood at 7 2,141 crore as compared to 7 1,912 crore in the previous year. The EBITDA for the year was 7 332 crore as compared to 7 274 crore in the previous year. If we adjust for impact of expected non-recurring events of 7 62 crore, the EBITDA stood at 7 394 crore. The Company had a positive cash profit of 7 340 crore excluding the one-off impact for the full financial year which translates into a cash EPS of about 7 21.7 Net Debt excluding lease liabilities was USD 123 mn as on March 31, 2022 against USD 101 mn as on March 31,2021. Capital expenditure for FY 2022 was approximately USD 61.2 mn, which includes both growth and maintenance capex.
As of today, we have a strong basket of about 17 APIs in Phase III development out of which 5 are in the final stages. These projects span therapeutic areas such as antibacterial infection, lymphoma, multiple myeloma, myeloid leukemia, hypersimplex and gastric related disease. In Europe, the Development Pipeline stands at USD 106.1 mn as of March 31st, 2022.
The Company continues to maintain its focus on low-volume, high-value orders and ensure high capacity utilization to ensure better margins and profitability.
RESEARCH AND DEVELOPMENT
Dishman has strong Research and Development capabilities with innovation being our driving factor in all activities undertaken; be it processes, technologies or products.
We continue to harness our cutting edge scientific and technological knowhow towards achieving breakthrough in tomorrows innovative therapies. We have ensured that our processes comply with the latest stricter regulations from various regulatory agencies and we continue to make them more efficient and environment friendly. We continue to make significant progress in our focus areas such as vitamins, disinfectants, oncology products, MRI agents and catalysts.
We are gradually making headway in the range of products related to irradiation chemistry owing to our unwavering focus since the last few years. We have successfully optimized the upstream chemistry which has helped us to improve the mass balance as well as reduce wastes. New irradiation equipment has been installed for niche vitamin D analogues.
BUSINESS HIGHLIGHTS (STANDALONE)
(7 in crores)
|Revenue from Operations||302.79||200.32|
|EBITDA (without other income)||34.19||(52.65)|
|(Loss)/Profit before interest and taxes||(40.17)||(127.85)|
|Interest and other finance charges||37.23||34.17|
|(Loss)/Profit before tax and exceptional Items||(7740)||(162.02)|
|(Loss)/Profit before tax||(83.31)||(162.02)|
|(Loss)/Profit after tax (including discontinued operations)||(31.55)||(232.81)|
|BUSINESS HIGHLIGHTS (CONSOLIDATED)||(7 in crores)|
|Revenue from Operations||2,140.69||1,912.03|
|(Loss)/Profit before interest and taxes||67.20||4.86|
|Interest and other finance charges||56.81||4761|
|(Loss)/Profit before tax and exceptional Items||10.39||(42.75)|
|(Loss)/Profit before tax||(4.25)||(65.03)|
|(Loss)/Profit after tax||18.01||(165.13)|
• A Excludes other income
• * Cash PAT = Adjusted PAT+(Depreciation - additional goodwill amortisation), adjusted for merger impact + exceptional item net of normalized tax, Adjusted PAT = Adjusted PBT- Normalised tax rate of 25% (Adjusted PBT excludes Goodwill amortisation, non-recurring impact of certain events and unrealized Forex Gain/loss)
• **Excludes non-recurring impact of certain events
• Net Revenue at 7 2,140.69 crores in FY22 as compared to 7 1,912.03 crores in FY21 increase by 12.0% YOY.
? CRAMS revenue increased by 15.1% YOY primarily due to : CRAMS India revenue increased by 199.1% due to continuous increase in commercial supplies from India.
? CRAMS CARBOGEN AMCIS revenue increased by 8.0% YOY due to increase in commercial revenue during the year.
• Marketable Molecules revenue increased by 2.5% YOY due to increase in revenues from Vitamin D analogues and cholesterol in CARBOGEN AMCIS BV.
• Adjusted EBITDA stood at 7 393.71 crores in FY22 as compared to 7 274.35 crores in FY21 mainly due to increase in EBITDA of India Operations.
• There is a Net Profit compared to Net Losses Last year due to substantial reduction of Net losses at India Operational Level and improved result at CARBOGEN AMCIS.
• Capital Expenditure for FY 2022 was approximately 7 463.80 crores which includes both growth and maintenance capex.
• Net Debt excluding lease liabilities was at 7 951.94 crores as on March 31,2022 as against 7 736.62 crores as on March 31,2021.
* Cash PAT = Adjusted PAT+(Depreciation - additional goodwill amortisation), adjusted for merger impact + exceptional item net of normalized tax, Adjusted PAT = Adjusted PBT- Normalised tax rate of 25% (Adjusted PBT excludes Goodwill amortisation, nonrecurring impact of certain events and unrealized Forex Gain/loss)
@ Excludes non-recurring impact of certain events
Adjusted PAT = Adjusted PBT- Normalised tax rate of 25% (Adjusted PBT excludes Goodwill amortisation and Forex Gain/loss)
# Working Capital cycle includes Debtors (Net of advances), Inventory and Creditors turnover in days.
SEGMENT-WISE OR PRODUCT-WISE PERFORMANCE
THE BUSINESS SEGMENT OF THE COMPANY COMPRISE THE FOLLOWING:
|Segment||Description of the activity|
|CRAMS||Contract Research and Manufacturing Segment under long term supply agreements.|
|Marketable Molecules||Bulk Drugs, Vitamin D Analogues, Intermediates, Quats and Speciality Chemicals|
THE BREAK-UP OF COMPANYS TOTAL INCOME FORM THE PRODUCT SEGMENTS VIZ."CRAMS SEGMENT" AND "OTHER SEGEMENTS" FOR THE LAST FIVE YEARS IS AS UNDER:
|Marketable Molecules (incl. others)||491.35||479.62||533.57||58784||419.39|
|Total Revenue from Operation||2,140.69||1,912.03||2,043.60||2,058.60||1,694.78|
KEY FINANCIAL RATIOS
|Particulars||FY 2021-22||FY 2020-21|
|Inventory T urnove r2||2.02||1.76|
|Operating Profit margin (%)3||11.29%||-27.50%|
|Net profit margin (%)4||-10.42%||-81.10%|
|Interest Coverage Ratio5||0.94||(0.51)|
|Return on Net Worth (%)#7||0.69%||-4.59%|
|Return of Capital Employed**7||0.98% H||-0.89%|
* Debt is calculated after deducting cash and cash equivalent, Bank balance and investments in marketable securities from gross debt
# Net worth is calculated after excluding Intangible assets on account of Merger from total net worth and Amortisation of goodwill has been added back net off effective tax to PAT for calculating net income
**Capital Employed includes Free Reserve less Intangibles
1 Variance is primarily on account of increase in net revenue and decrease in average trade receivables.
2 Based on Cost of goods sold plus manufacturing expenses
3 There is improvement in Operating profit ratio is due to improvement in revenue and earnings of the Company.
4 There is improvement in net profit ratio is due to improvement in revenue and earnings of the Company.
5 Interest Coverage ratio improve aided by decrease in interest cost owing to debt repayment and increase in earnings available for debt service driven by higher operating revenue during the year.
6 Debt-Equity Ratio has decreased due to lower working capital loan utilisation.
7 There is an improvement in Return on Net worth and Return of Capital employed ratios are due to improvement in financial performance indicated by lower Net Losses compared to last year.
|PARTICULARS||FY 2021-22||FY 2020-21|
|Operating Profit margin (%)@3||18.39%||14.35%|
|Net profit margin (%)@4||0.84%||-8.64%|
|Interest Coverage Ratio?5||1.52||0.64|
|Return on Net Worth (%)#@7||6.52%||-7.14%|
|Return of Capital Employed**?7||5.37%||3.37%|
* Debt is calculated after deducting cash and cash equivalent, Bank balance and investments in marketable securities from gross debt **Capital Employed includes Free Reserve less Intangibles
# Net worth is calculated after excluding Intangible assets on account of Merger from total net worth and Amortisation of goodwill has been added back net off effective tax to PAT for calculating net income
?Earnings excludes non-recurring impact of certain events
1 Overall Debtors Turnover ratio increased due to efficient collection of receivables.
2 Based on Cost of goods sold plus manufacturing expenses
3 Operating profit ratio improved due to increase in EBITDA majorly at India level.
4 Net profit ratio improved due to substantial decrease in Loss After Tax at India level.
5 Interest Coverage ratio improvement due by increase in earnings available for debt service driven by higher operating revenue majorly at India level.
6 Debt-Equity Ratio is higher due to increase in borrowing for capex purpose
7 There is an improvement in Return on Net Worth and Return on Capital employed ratios are due to substantial decrease in Net Losses at India level.
INTERNAL CONTROL SYSTEMS
Your Company has a well-established system of internal control and internal audit, commensurate with its size and complexity of the business and considering the essential components of internal control stated in the Guidance Note on Audit of Internal Financial Controls Over Financial Reporting ("the Guidance Note") issued by the Institute of Chartered Accountants of India ("the ICAI"). Your Company has appropriate internal control systems for business processes with regards to efficiency of operations, financial reporting, compliance with applicable laws and regulations, among others and with the objective of safeguarding the Companys assets, ensuring that transactions are properly recorded and authorised and providing significant assurance at reasonable cost, of the integrity, objectivity, and reliability of financial information. The Company continually upgrades internal control system by adding better process control, various audit trails and use of external management assurance services, whenever required. The internal control system is supplemented by extensive internal audits, conducted by independent firms of chartered accountants in close coordination with finance and account department. The findings of Audit Team are discussed internally as well as in audit committee meetings. The Audit Committee of the Board of Directors reviews the adequacy and effectiveness of internal control systems and suggests improvement for strengthening them. The company has established controls department to ensure new controls implementation where necessary. With upgrade of S4 HANA platform, company is establishing robust system controls. Company is focusing on business process re-engineering with support of new technologies. Automated controls are being introduced to ensure robust control environment. Computer system validation is in progress for better system controls. SAP system validation is initiated to have validated reporting system Caliber end to end quality management system is being implemented to have workflow driven process automation, drive better decisions, and store data securely.
Global operations and product development for regulated markets pose significant challenges and risks for the organisation. Such risks, if not identified and addressed properly in a timely manner could adversely impact accomplishment of the overall objectives of the organisation and its sustainability. An effective risk management framework enhances the organisations ability to proactively address its risks and opportunities by determining a risk mitigation strategy and monitoring its progress on continuous basis. Our Enterprise Risk Management (ERM) framework encompasses practices relating to identification, assessment, monitoring and mitigating of various risks to key business objectives. Its purpose is to assess how big the risks are, both individually and collectively, in order to focus managements attention on the most important threats and opportunities, and to lay the groundwork for risk response. ERM at Dishman seeks to minimise adverse impact of risks on our key business objectives and enable the Company to leverage the market opportunity effectively. Our risk management framework is intended to ensure that risks are identified in a timely manner. By identifying and proactively addressing risks and opportunities, we protect and create value for our stakeholders, including owners, employees, customers, regulators, and society overall. We have implemented an integrated risk management framework to identify, assess, prioritise, manage/mitigate, monitor and communicate the risk across the Company. Senior management personnel are part of our risk management structure. Plant level committees headed by senior management personnel meet at regular intervals to identify various risks, assess, prioritise the risks. After due deliberation, appropriate strategies are made for managing/mitigating the risks. The Company takes the help of independent professional firms to review the risk management structure and implementation of risk management policies. Audit Committee, on a quarterly basis, reviews the adequacy and effectiveness of the risk management strategies, implementation of risk management/ mitigation policies.
Audit Committee advises the Board on matters of significant concerns for redressal. The risk registers are prepared, and action plans are in place for mitigation of risks.
OPPORTUNITIES AND THREATS
Most of the innovator companies are facing challenge of depleting research pipeline and losing patent protection for their blockbuster drugs in the next few years. The new drug discovery process is also becoming more difficult with reducing success probabilities and increasing research and development costs. This has opened up opportunities to CRAMS players from low-cost destinations like India. Dishman has identified this opportunity very early and started working with innovators with customs synthesis projects and contract manufacturing of APIs, which result into overall growth in the turnover. In view of the huge potential the CRAMS segment offers to Indian companies, many of the big pharmaceutical companies in India started exploring opportunities for a share in CRAMS segment with big investments. This may result in increased competition in the long run. However, with the research and innovation capabilities that Dishman has developed over the years across the globe, the technical know-how is unparalleled. In addition to the above, another major development has been on the New Molecule Entities (NMEs) front. Most of the recent innovation in this segment is from "small to mid-sized" bio-pharmaceutical organisations. This has changed the dynamics of this business, as large pharmaceutical players are increasingly becoming mainly marketing and "finished dose form" organisations.
The Company believes that it can manufacture various APIs/ intermediates and speciality chemicals of best quality at a low cost. Many of innovator companies are outsourcing their products to our Company. Recognising this opportunity, the Company continued to take initiatives in reducing its costs by employing lean manufacturing techniques and resource management initiatives and broadening the product base.
The Companys goal is to make all business processes as much automated as possible thus increasing the efficiency and accuracy of all processes. Dishman has developed a framework to harness the opportunities presented by prevalence of new- age digital technologies and transform to become a digitally savvy pharmaceutical company. In analytics and automation, the Companys strategy has been to capitalise on the latest advancements in technology for improving the business performance. As a part of digital reinvention journey we have done:
SERVER AND END POINT SECURITY
We have taken this to the next level, we have migrated all our server security and end point security on OEM cloud along with XDR enablement, by this step we are not only updated and upgraded at any point of time but also track and trace if any kind of virus / hacker attack happens, we can also able to handle zero day attack as it is having AI which analyse the behaviour and take action accordingly.
We have upgraded our infrastructure on a large extend and also make our infrastructure as hybrid in which we move required applications on Cloud to increase its availability, security, scalability and reduce physical management of servers and data centre which not only reduce cost but also make our system and application, easy to manage.
We have done a lot of work in digitization of data so that we can get meaningful and correct information, which in turn help us in taking right decision on right time. We have done implementation of new version on CDS application and upgrade and update all the required instrument compatible with that, we have also initiated EQMS application implementation to track all kind of deviations and control related to Product, Practices and Procedures. We have also get all core product related module in our ERP system validated as per CFR 21 complaint which is a huge exercise.
In this year we have done massive exercise of removing electronic waste from all the Dishman India location with the government authorised partner following all the required guidelines of E Waste management.
INDUSTRIAL RELATIONS AND HUMAN RESOURCE MANAGEMENT
The Company has continued with its drive to institutionalise and upgrade its HR processes and policy and in line with this drive, we have implemented national pension scheme for our employees as part of social security program, and Attendance scheme for our workmen as to enhance productivity and connect to business. In the area of employee engagement, we rolled out several programs like celebration of Navratri ,Rangoli competition during Diwali, organised outdoor sports activities like Dishman Badminton Tournament, Celebration of International women day and tie-up with Sneh womens Hospital and Concept Diagnostic centre for Womens Health and Wellness. We have successfully implemented the SAP Success Factors system in India, we are also planning to have similar system in our overseas operation and necessary work has already been initiated in this direction. Regular Heath, Safety, Environment and covid meeting were organised to ensure all the safety protocols are followed, Vaccination drive was also initiated to ensure all our employees get vaccinated. We also acquired Oxygen Concentrators to be kept at all our locations to meet any Oxygen related emergencies. People development and retention is core pillars of our mission & we rolled out behaviour training programs for our executives, At the same time, robust induction and orientation programs for new joinees give in-depth knowledge of our processes and systems. With a view to induct new brain in the system, we rolled out our trainee scheme in line with industry benchmark and in this initiative, we recruited trainees from various reputed universities in our manufacturing sites and deployed in various processes after structured induction and orientation. The Company, as on March 31, 2022, had 1,168 employees on its rolls. We aligned our HR processes and systems as to continue attract excellent talent both from within and outside India in line with our business requirements. Industrial Relations continue to be cordial.
This document contains statements about expected future events, financial and operating results of Dishman Carbogen Amcis Limited, which are forward-looking. By their nature, forward looking statements require the Company to make assumptions and are subject to inherent risks and uncertainties. There is significant risk that the assumptions, predictions, and other forward-looking statements will not prove to be accurate. Readers are cautioned not to place undue reliance on forward-looking statements as a number of factors could cause assumptions, actual future results and events to differ materially from those expressed in the forward-looking statements. Accordingly, this document is subject to the disclaimer and qualified in its entirely by the assumptions, qualifications and risk factors referred to in the managements discussion and analysis ofDishman Carbogen Amcis Limiteds Annual Report, FY2022.