Ind-Swift Labs. Management Discussions


An economic overview

Global Economy: Weak economic growth, persistent inflation, and rising interest rates in the major developed economies have cast a pall over the global economys near-term prospects. Recovery is still being impeded by the pandemics lasting consequences, the protracted conflict in Ukraine, and the aggravating effects of climate change. It is anticipated that global headline inflation will decrease from 8.7% in 2022 to 6.8% in 2023 and 5.2% in 2024.

The 10-year economic prognosis suggests that firms will face ongoing challenges and uncertainty, but there will also be opportunities. Over the next ten years, mature markets will contribute less to the global GDP as global growth resumes its decreasing trend.

Additionally, despite the instability in the worlds supply chains and the high cost of commodities, world trade reached a record high in CY22. Likewise, by the end of 2022, inflation had decreased to a modest level as a result of policy rate tightening. Furthermore, a rise in overall trade volumes suggests that customer demand is resilient.

Indian Economy: The Indian economy has bounced back since the COVID-19 pandemic. The continued momentum indicates Indias buoyancy and ability to recover from the hindrances caused by the global health crisis.

—-Indias economy expanded by 6.1% in the Q4 of the fiscal year 2022-23, leading to an annual growth rate of 7.2% as compared to the growth rate of 9.2% in 2021-22. Although the figures show a negative result, India has grown significantly compared to the world economic growth rate.

India is now the fifth-largest economy in the world due to its strong economic foundations, thriving domestic demand, careful financial management, high saving rates, and favourable demographic trends. The countrys major economic contributors are traditional and modern agriculture, technology services, the handicraft industry, and business outsourcing.

A noteworthy factor in Indias growth is the increase in imports of capital goods, which surged by almost 20% in FY23 compared to the previous year. This indicates improved private sector capital formation and instills confidence in the countrys economic prospects. Indias overall exports in April 2023 were estimated at US$ 65.02 billion, a positive growth of 2%.

With 17% of the nations GDP and over 27.3 million workers, the manufacturing sector plays a significant role in the Indian economy. Through the implementation of different programmes and policies, the Indian government hopes to have 25% of the economys output come from manufacturing by 2025.

GST registrations have grown across states, leading to greater formalization of Indias economy and resulting in higher revenues. GST revenues have grown from C8.76 trillion in 2018- 19 to C 13.25 trillion in 2022-23 at a compounded annual growth rate of nearly 11 percent.

The countrys retail inflation slipped to a more than two-year low of 4.25% in May 2023. CPI hit the highest of 7.79% in Apr. 2022, and the lowest of 4.06% in Jan 2021. The wholesale price inflation declined to -0.92% in Apr. 2023, from 1.34% in March. The RBI had declared a rate of 6.5% against the tolerance limit of 6% to curb inflation, primarily caused by external factors such as the Russia-Ukraine conflict.

For fiscal 2022-23, the growth in IIP works out to be 5.1%, down from 11.4% in the preceding year.

The Indian economy is set for real GDP growth of about 6 -6.5% in FY 2023-24, which compares favourably with emerging market peers amid a broad global slowdown. Consumer activity would be the lead driver of growth and the financial sector would be resilient amidst global challenges.

The Pharmaceutical Sector

Today, medicine is expected to cure every ailment. Pharmaceuticals have contributed to improvements in the life expectancy and quality of life of many. It is driving medical progress by researching developing, and bringing new medicines that improve health and quality of life for patients around the world, being a key asset to the global economy.

Global Pharma Market:

Uncertainties of the global pandemic have created opportunities for the healthcare system across the world. The COVID-19 pandemic continues to impact pharmaceutical markets globally and is estimated to expand the net cumulative pharmaceutical market by US$ 500 billion from 2020 through 2027.

The pharmaceutical industry is responsible for the research, development, production, and distribution of medications. The market has experienced significant growth during the past two decades, and pharma revenue worldwide totalled US$ 1.48 trillion in 2022. Pharma heavily relies on R&D, investing over 20% of sales in it.

The U.S. market, on a net price basis, is forecast to grow -1 to 2% CAGR over the next five years, down from 4% CAGR for the past five years. Spending on medicines in the U.S. at invoice prices is expected to increase by US$ 134 billion through 2027, slower than the US$164 billion increase over the past five years. Overall medicine spending at invoice prices is expected to reach US$ 763 billion by 2027 and net spending increases by only US$ 18 billion over five years.

Spending in Europe is expected to increase by US$ 59 billion through 2027, with a focus on generics and biosimilars, and escalating pressures on the value and negotiated prices of novel medicines. Generics, including biosimilars, are expected to add US$12 billion in growth over the next five years, about the same as in the past five years. Over the next five years, more than 200 new active substances (NASs) are expected to launch in the leading European countries and new products in aggregate are likely to contribute US$ 45 billion in spending.

Latin America and Eastern Europe represent two of the fastest-growing regions in terms of medicine spending globally. Latin Americas growth is led by Brazil and Mexico at 9-12% and 7.5-10.5% respectively, and together they represent two-thirds of the spending in the region overall. In Eastern Europe, growth is led by Russia, which is projected to grow 6-9% CAGR through 2027.

The impact of the pandemic on medicine spending growth has been significant in some markets across the Asia-Pacific region, but these are expected to moderate and return to 5.5-8.5% growth through 2027. Key countries in the region include two higher-income developed markets — South Korea with a growth of 4.5-7.5% and Australia growing at 2-5% before discounts and rebates.

Japans medicine spending growth is projected at -1 to 2% through 2027 as robust brand growth is offset by a shift in annual price cuts and ongoing moves to generics. Spending growth in China is expected to slow, with positives driven by greater uptake and use of new original medicines and offset due to pressures on off-patent and generic pricing.

The total spending and global demand for medicines will increase over the next five years to approximately US$1.9 trillion by 2027. The underlying growth rate of 3-6% in spending will be driven by new drug launches and wider use of recently launched brands despite efforts by payers to constrain their budgets coupled with the impact of lower-cost options.

Demand for innovative drugs will drive oncology spending to approximately US$ 370 billion by 2027, almost double the current level. Biotech medicines will represent 35% of spending globally in 2027 and will include both breakthrough cell and gene therapies, as well as a maturing biosimilar segment.

Specialty medicines will represent about 43% of global spending in 2027 and 56% of total spending in developed markets.

Global spending on cancer drugs is expected to reach US$ 370 billion by 2027, with growth accelerating from the launch and use of novel drugs and limited new biosimilar impact. Immunology spending growth will slow to 3-6% through 2027 from price reductions associated with biosimilar competition as volume growth continues at 12% annually.

Treatments for autoimmune disorders are forecast to reach US$ 177 billion globally by 2027, driven by steadily increasing numbers of treated patients and new products, and the offset after 2023 due to biosimilars. New therapies for rare neurological disorders, Alzheimers, and migraines are expected to drive spending growth in neurology.

Indian Pharma Market: The

Pharmaceutical industry in India is the 3rd largest in the world in terms of volume, and 14th largest in terms of value. The Pharma sector currently contributes to around 1.32% of the countrys GDP. India being the largest supplier of generic medicines, it manufactures about 60,000 different generic brands across 60 therapeutic categories accounting for 20% of the global supply of generics.

Indian medicines are preferred worldwide, thereby rightly making the country the "Pharmacy of the World". The sector this year was marked by a greater degree of collaboration between the government and industry, with both playing a pivotal role in helping the sector further strengthen its position in the global market.

Indian Pharmaceutical Industry plays a major role to supply affordable generic medicine in the world at a very affordable price and of reliable quality. India is the number one exporter of generic medicine (>20 percent) and the value of export of medicine from the Indian market is around US$ 14 billion with a growth of 30% yearly. Currently, drugs manufactured in India are being exported to more than 200 countries, and the United States is one of its biggest markets. India is the largest contributor to UNESC with over 50-60% share.

The sector also faced challenges this year, however, as the industry expands its footprint around the world, it will need to continuously invest in upgrading manufacturing standards to keep its promise of being a high-quality, reliable supplier of medicines to the world.

Performance in FY23: The current market size of the medical devices sector in India is estimated to be US$ 11 billion and its share in the global medical device market is estimated to be 1.5 percent. The Indian medical device market share in the global market is estimated to be 1.65 percent. According to Economic Survey 2023, the turnover in the domestic pharmaceutical market was estimated to be US$ 41 billion. Indias pharmaceutical export revenue was US$ 25.3 billion in fiscal year 2022-23.

Outlook: The year 2023 holds a positive outlook for Indias pharmaceutical industry, with a deeper focus on quality manufacturing, affordability of drugs, and adoption of innovation and technology, experts have said. The Indian pharmaceutical industry includes a network of 3,000 drug companies and 10,500 manufacturing units. It is projected to reach a value of US$ 130 billion by 2030.

Active Pharmaceutical Ingredient (API)

Active Pharmaceutical Ingredient (or API) is a crucial segment of the pharma industry, contributing to around 35% of the market. Active pharmaceutical ingredients (APIs) are the active components in a pharmaceutical drug that produce the required effect on the body to treat a condition. API is a chemical compound that is the most important raw material to produce a finished medicine.

Despite high manufacturing expenses, strict regulatory policies, and policies in controlling drug prices in many countries, attractive opportunities have emerged in the API market due to growing cases of chronic diseases, including diabetes, asthma, and cancer.

The active pharmaceutical ingredient (API) market is expected to reach US$ 369.56 million by 2030, which is US$ 223.3 million in 2022, and is expected to undergo a CAGR of 6.50% during the forecast period 2023 to 2030.

The growth can be attributed to the advancements in active pharmaceutical ingredient (API) manufacturing and the rising prevalence of chronic diseases, such as cardiovascular diseases and cancer. Favourable government policies for API production, along with changes in geopolitical situations, are boosting the market growth. The API market is undergoing immense changes due to supply chain disruption by COVID-19.

Countries such as India are being preferred over China for the export of API owing to geopolitical situations and the demand to reduce dependence on China for API products. Furthermore, governments of many countries have formulated plans and granted incentives to promote the production of API.

Innovative APIs held the largest share of 47.07% in 2022. This growth is attributed to increasing R&D initiatives for novel drug development and favourable government regulations. As a result of extensive research in this field, several innovative products are now in development and are expected to launch in the forecast period. New entrants in this segment are expected to drive market growth.

India has embarked on an ambitious plan to cut dependence on China for key raw materials as it seeks to become self- sufficient in its quest to be the pharmacy of the world.

Already the worlds third-largest manufacturer of medicine by volume, India has one of the lowest manufacturing costs globally. About one in three pills consumed in the U.S. and one in four in the U.K. are made in India.

However, Indias US$ 42 billion pharmaceutical sector is heavily dependent on China for key active pharmaceutical ingredients or API — chemicals that are responsible for the therapeutic effect of drugs.

According to a government report,

India imports about 68% of its APIs from China as its a cheaper option than manufacturing them domestically.

That may be starting to change. Under a government scheme launched two years ago, 35 APIs began to be produced at 32 plants across India in March. This is expected to reduce dependence on China by up to 35% before the end of the decade.

The Indian API market is anticipated to increase at a CAGR of 13.7% during the first four years - about 8% higher than the generic API industry. The Indian API space has become lucrative for several investors and venture capitalists. Indias robust domestic market, advanced chemical industry, skilled workforce, stringent quality and manufacturing standards, and low costs (about 40% less than that in the West) for setting up and operating a modern plant give an added advantage.

The prevailing political pressures between the West and China has also pushed the global pharma majors to source from countries other than China. Indias emergence as the alternate source of bulk drugs has been quite remarkable.

About Ind-Swift Laboratories

Ind-Swift Laboratories Ltd. is a global manufacturer of APIs, Intermediates, and formulations (through group collaboration). Headquartered in Chandigarh, India, Ind-Swift Laboratories Ltd. has two state-of-the-art manufacturing facilities at Derabassi and Jammu, which comply with global operating standards. It also holds a global leadership position in the Macrolide Antibiotic segment. With leading global pharmaceutical formulators across the world, the Companys products find global acceptance.

Through a series of forward and backward integrations, today the company manufactures all stages of drug substance/product including new chemical/molecular research to formulation development. Their targeted domains lie at the interaction of Technology and Business, at a point where maximum value can be obtained for the organization as well as society.

Research & Development

Located in Mohali, Ind-Swift has a state-of-art DSIR certified Research and Development Centre. It forms the backbone of the organization and, along with the Process Development Laboratories & Support Centre located at the Derabassi manufacturing site, it is involved in the following three broad areas of research:

• New API Development

• Process Improvement of existing commercial APIs for leadership positions in quality, cost, and capacity

• Contract Research /Manufacturing Services (CRAMS) of API / Intermediate and Material science (Non - Pharma) stream

Having achieved ISO certifications i.e., ISO 14001:2015 and ISO 45001:2018 after successful compliance and audit process in April 2022. Being a research driven centre, R&D is in a state of compliance of Quality Management System and good labroratory practices.

Ind-Swift Laboratories Limited has a broad pipeline of new APIs covering all therapeutic segments. Some of these APIs are currently in the development stage at R&D while others are at the commercialization stage. Customer seeding has been initiated to promote the API business. A cursory overview of these new APIs and their current status reveals:

• Sitagliptin Phosphate Monohydrate - One of the promising molecules in the anti-diabetic segment wherein the product has been validated at plant scale and launched in the Indian market in July 2022. After the expiry of the patent, process validation at the plant level is planned in Q3 FY2023-24 for launch in regulatory markets.

• Pazopanib* - Process validation at both laboratory scale and plant scale has been completed. ODMF is available and customer seeding efforts are ongoing.

• Ibrutinib* - Validation at the laboratory scale has already been done; process validation in the plant is planned to start in Q2 2023-24.

• Ivabradine Alpha Form* - Process validation at both laboratory scale and plant scale has been completed and customer seeding efforts are ongoing to launch this product post-patent expiry.

• Ivabradine Epsilon Form* - This is an alternative polymorph of Ivabradine HCL developed to cater to the requirements of a European customer; process validation at both laboratories. scale and plant scale has been completed.

• Lisdexamfetamine Dibesylate* - A salt-differentiated product has been developed by ISLL to launch in certain EU countries; process validation at both laboratory scale and plant scale has been completed.

• Donepezil Base* - Process validation at both laboratory scale and plant scale has been completed. This product has got niche usage in the form of transdermal patches.

• Mirabegron* - A new API wherein validation at the laboratory . scale has been completed, and process validation in the plant is ongoing.

• Bempedoic Acid* - Process development of this new API is completed and validated at the laboratory scale. Process validation in the plant is scheduled to be performed in FY2023-24.

• Eltrombopag Olamine* - Process development of this new API is completed and validation at the laboratory scale is ongoing. Process validation in the plant is planned in FY2023-24.

• Ivacaftor*- New API is currently under laboratories development.

• Tegoprazan* - New API is currently under laboratory development for the Korean market.

• Cenobamate* - New API is currently under laboratory development.

As part of the continuous improvement approach and promoting green chemistry, the organisation has started investing in emerging areas of process technology such as Biotransformation. Here enzymatic technologies are being used to substitute chemical processes with enzymatic processes for competitive advantage.

Similar process technologies are integrated into the vertical integration of starting materials and intermediates of commercialised APIs.

PD Labs work is based on the concept of Kaizen wherein process and operational improvements are underway in the existing commercial products like Atorvastatin Calcium, Fexofenadine Hydrochloride, Ezetimibe, Clopidogrel Hydrogen Sulfate, Ropinirole Hydrochloride, and Lisdexamfetamine Dimesylate. These continuous improvement initiatives have played a significant role to enhance the quality attributes of APIs, as well as bring down the cost of manufacturing in order to remain competitive in global markets. PD lab also extends support on a day-to-day basis to the commercial projects running in the plant.

CRAMS (Contract Research and Manufacturing Services) is another vertical where R&D offers services like Process Development / Research Services Custom Chemical Synthesis (CCS), Contract Manufacturing, and Full-time Equivalents (FTEs) for Chemistry expertise in the area of API / Intermediate and Material science (Non - Pharma) stream.

Under CRAMS vertical, the organisation has also undertaken some projects related to the material science (non- nuclear applications) stream involving Deuterated chemistry in which the C-H bond is being replaced with a C-D bond.

There is a resurgent application of Deuterium chemistry in material science as well as in the Pharma sector. R&D is developing the expertise and capability to handle deuterium chemistry for material science and the same capability will be extended to deuterium labelled APIs to enter into a new frontier of pharmaceutical research.

Under CRAMS, Ind-Swift collaborates with various overseas customers because of which some of the API and intermediates projects have reached the commercial stage. Various projects related to the material science (Non-pharma) stream, ranging from initial process development to commercialisation, have been undertaken in the FY 2022-23.. Through its innovative work, CRAMS vertical thus also supports revenue generation for the organization.

The research team of the organization is also involved in creating intangible wealth for the organization through innovation and protects them by filling patent applications. In FY2022-23, the organization filed four process patents and one product patent.

^Products subject to patent protection are not offered or supplied for commercial purpose in countries where this constitutes infringement of patent rights. Products under patent production are available pursuant to section 107A(a) of Indian Patent Act, 1970.

1) Regulated Markets

The US

Clocking a value of US$ 435 billion in 2022, the North American generic drug market is anticipated to reach US$ 721 billion by 2032. One primary reason for the substantial rise in production in the US is that generic drugs are more cost-effective than branded drugs; extensive research and testing are not prerequisites. In addition, the use of generic drugs has enhanced the social benefits of the American healthcare system by providing equitable access across classes and generating savings for taxpayers, employers, and insurance providers.

The US generic drug market is experiencing continuous growth owing to the rising prevalence of chronic diseases like cardiovascular diseases, diabetes, Alzheimers disease, and Parkinsons disease.

The recent implementation of the Drug Completion Action Plan of the FDA, aiming to eliminate impediments faced by generic drug manufacturers, has led to a rise in the number of generic drug approvals. This is coupled with the US Food and Drug Administration (USFDA) reauthorising the Generic Drug User Fee Amendments in 2017.

The GDUFAII allows the flow of financial resources (collected through user fees) from generic drug manufacturers to the FDA to empower the latter with more generic-drug reviews and approvals. The US Government has further encouraged the promotion of generic substitution by introducing several targeted schemes alongside incentivising physicians and pharmacists.

Ind-Swift in the US

Ind Swift is one of Indias leading API suppliers to the US generic industry. The Company continued commercialising multiple APIs to the US generic market during the year. Consistent with its agreements with North American pharmaceutical companies, the Company has been timely executing its manufacturing and supply commitments. The Company continues to brace its CRAMS portfolio with commercial supplies of various new and current products to a renowned US organisation

Europe

The API market was valued at US$ 56.75 billion in 2022 and is expected to reach US$ 105.20 billion by 2030, at a CAGR of 8.02% from 2023 to 2030. The rising incidence of chronic diseases has boosted the market; according to the International Diabetes Federation, approximately 463 million people worldwide were diagnosed with diabetes in 2019 alone.

Furthermore, the annual number of prospective cancer cases is likely to reach 23.6 million by 2030. Many other diseases are also rising, leading to an increased sourcing trend from quality-based manufacturers based out of India and China.

Ind-Swift in Europe

The Company has devised a comprehensive plan to foster productive collaborations with prominent pharmaceutical companies in Spain, Turkey, Italy,

Greece, France, and Germany. While the utilisation of drug therapies for cardiovascular ailments continues to grow, ISLL has focused on establishing long-term supply agreements with relevant clients throughout the European market. Europe is the second most profitable market for ISLL, with Atorvastatin, Ezetimibe, Ivabradine, and Lisdexamphetamine being the key growth drivers and revenue generators. Additionally, recognising the potential in the field of anticancer treatments, ISLL intends to introduce its products promptly to reinforce its presence in the region.

Japan

Having secured a position among the top ten markets for generic drugs, Japans API market, in particular, is expected to experience a growth rate of approximately 7.0% until 2025, followed by further anticipated increases. Japans sizeable expenditure on healthcare research and development of pharmaceutical drugs and the presence of API manufacturers contribute to the countrys market expansion.

Additionally, the consistent rise in chronic diseases like cancer and cardiovascular diseases (CVDs) has created room/carved out a space for drug manufacturing in Japan targeted specifically toward these health conditions. However, historical data reveals that the penetration of generic drugs in Japan is still lower than in other developed markets like the United States and Europe. Several factors, for instance, higher costs associated with branded formulations, are responsible for this slackened penetration.

Due to the rising expenditure on public healthcare resulting in price fluctuations, the government is now forced to adopt a biannual drug price revision strategy to promote the distribution of generics in the market actively. Generics account for approximately 47% of sales in volume, but the government aims to raise this share to 80%. These initiatives have made possible robust growth in the penetration of generics in recent years.

Ind-Swift in Japan

ISLL is one of the leading market share holders in exporting generic APIs to Japan. In addition to the ample commercial volume supplies of over four products, ISLL continues implementing its business strategy of adding a drug substance (final product or intermediate) each year. ISLLs expansion of its product portfolio with new developments for existing APIs and new APIs at sizeable numbers is anticipated to be completed by the end of March 2024.

India

The Indian pharmaceutical industry has been soaring high over the past few decades, contributing around 1.72% of the nations GDP India is also the 3rd largest producer of API, accounting for an 8% share of the Global API Industry. 500+ APIs are manufactured in India, contributing 57% of APIs to the prequalified list of WHO.

The Indian API market is anticipated to increase at a CAGR of 13.7% during the first four years - about 8% higher than the generic API industry. The Indian API space has become lucrative for several investors and venture capitalists. A robust domestic market, advanced chemical industry, skilled workforce, stringent quality, manufacturing standards, and low establishment and operation costs of a modern plant give the Indian API space an extra advantage.

This growth of Indias API market can be attributed to the increasing geriatric population in India, which now tops the world. In 2022, Indias pharmaceutical business transformed remarkably, transitioning from a volume producer to a valued supplier. Post-COVID-19, the Indian pharma sector has gained momentum as a critical player in the global markets.

The Department of Pharmaceuticals has also given "in-principle" approval to proposals from Himachal Pradesh, Gujarat, and Andhra Pradesh under the "Promotion of Bulk Drug Parks" scheme. This is a crucial initiative to support bulk drug manufacturing in India. The scheme, with a budget of H3000 crores, provides financial aid to these three states for the creation of bulk drug parks to reduce the cost of manufacturing bulk drugs by establishing world-class common infrastructure facilities and increasing the competitiveness of the domestic bulk drug industry.

On the other hand, the Government of Assam has also proposed a Pharmaceutical park in Chaygaon,

Kamrup Rural, on a land area of 100 acres with an estimated project cost of H153.64 crores. Furthermore, various measures have been proposed to encourage innovation within the industry, such as raising the limit for foreign direct investment (up to 100%, FDI has been allowed through an automatic route for Greenfield pharmaceuticals projects) and implementing a new strategy for protecting intellectual property rights.

Ind-Swift in India

Ind Swift Labs Limited, a leading manufacturer of APIs, has commanded a powerful position in the domestic segment, offering products across multiple (20) therapeutic segments, including niche and chronic segments like Oncology, Cardiology, Antibiotic, and Anti Allergic.

Throughout the financial year, leading formulation manufacturing companies continued to appreciate our API products quality and regulatory support.

Key products such as Clopidogrel, Clarithromycin, Atorvastatin, Fexofenadine, and Ivabradine continue to sustain market share and profitability. Clopidogrel and Ivabradine maintained the lead as the highest-growing products on a YOY basis.

The Company maintained the lead in Clarithromycin powder and Granules despite pressure on disseminating intermediate and Chinese products. The last financial year saw healthy growth for Pentazocine, which gained 90% of the market share. Newly introduced Lisdexamphetamine Dimesylate, which is used to treat attention deficit hyperactivity disorder (ADHD) and binge eating disorder, is being offered for development purposes only and has received positive responses from various leading Indian manufacturers for launch in domestic and EU/UK/ROW markets for formulation.

Business association on newly introduced molecules, Eltrombopag Olamine,

Mirabegron, and Acamprosate, are taking a holistic shape and is expected to be a good revenue generator in the near future. Specialty and Niche Oncology molecules, Ibrutinib and Pazopanib HCl have already begun penetrating various companies.

On the development front, significant revenue is expected post-patent launch in the domestic market and through the formulation introduction by business partners in EU/ROW.

Our direct business association with partners and prestigious Indian companies and MNCs like Sun Pharma, Cipla, Lupin Limited, Micro Labs, Abbott Ltd., Intas, Torrent Pharma, etc., and other leading formulators (FDF) have been gateways to success.

As the leading blockbuster Ivabradine manufacturer, we offer this superior product through our associate Company on P2P to cater to the super specialty cardiac segment. Ivabradine is used for specific symptomatic management of stable angina pectoris.

We associate with prestigious Indian companies and MNCs like Lupin Limited, Abbott Ltd, and Torrent Pharma. The business of Ivabradine formulation has seen stupendous success in India since its launch in 2009.

Our new add-on business has also achieved commendable success as we associated with pharma giants such as Ajanta Pharma, Macleods Pharma, Mankind Pharma, Madras Pharma, Medreich Ltd., and many European- based companies for domestic and joint development in ROW markets.

Growth on the API front has been stable, and with the new business developments, tapping new companies and adding on trade verticals will ensure a healthy financial year ahead

South Korea

South Koreas pharmaceutical value of export drug products nearly amounted to 601.9 million US dollars in the month of May 2022, and Indias export of pharmaceuticals to South Korea touched US 166.94 million during the financial year 2022-23, growing by 34% over the financial year.

According to a recent report from Fitch Solutions, despite persisting concerns surrounding the lag in drug approvals in the country, the pharmaceutical sector remains strong. The report further added that high per-capita pharmaceutical expenditure and the countrys highly innovative research and development (R&D) environment will ensure that the pharmaceutical market continues to be lucrative.

Ind-Swift in South Korea

ISLL has met its objective of registering one new product to the already approved 10 KDMFs. ISLL has also devised a strategy of targeting nearly off-patent complex molecules, hence providing an early market opportunity. Since 2020, several key developments to forge new products have been underway to further increase our market share in this region, with new molecules already identified to add to the current portfolio.

China

China has the highest proportion of the Active Pharmaceutical Ingredients (API) market in the Asia Pacific. Although a significant portion is due to exports, Chinas import of APIs has slightly risen due to the government easing restrictions as global economies adjust and resume functions following the COVID-19 pandemic.

According to a recent article, digestive and metabolic drugs and systemic anti-infective drugs account for nearly 14% of the Chinese pharmaceutical market. Cardiovascular and central nervous system drugs each account for slightly less at 13%, while patent and generic drugs account for relatively similar market shares at 56% and 44%, respectively.

Ind-Swift in China

Ind-Swifts business anticipation of China has been on volume sales with price sensitivity due to several emerging markets that have gained pace post the COVID-19 pandemic leak.

Additionally, Ind-Swift has obtained five IDLs with one product at the commercial stage and four product approvals for which the commencement of supply of developmental quantities has been initiated. In continuation, two more products have also been filed in conjunction with the current guidelines/CTDs and are under review and awaiting final approval.

Additionally, market development activity for those products is also underway alongside fresh filings. At present, China holds a pipeline of over 700 molecules, and ISLLs regulatory and marketing strategies for quick approval of products have given it an advantage over many other suppliers in this region, thereby registering good growth.

Bangladesh

In Bangladesh, the pharmaceutical sector has seen stable progress as far as revenue generation is concerned.

Apart from meeting the domestic demands of pharma formulations, the pharma industry also earns enormous foreign exchange from its exports.

With an existing market value of about US$ 3 billion, the Bangladesh pharma manufacturing industry is progressing rapidly with great potential, as 98% of the countrys total demand for medicine is being met by nearly 300 domestic manufacturers. However, it relies heavily on imports until its local industry is equipped with pace and technology.

The anticipated market size of the Bangladesh pharmaceutical industry is expected to grow to more than US$ 6 billion by 2025, post registering an absolute growth of 114% from 2019. The country currently offers more than 450 generic drugs, and the local market has a continuous upward trend. In the recent past, however, market instability due to a shortage of raw materials, transport cost hikes, and the dollar crisis has greatly impacted several exporters from India.

Ind-Swift in Bangladesh

With its long-established supply relationship, Ind-Swift has been able to withstand this impact and keep its business presence stable in this region. Significant exports of APIs such as Nitazoxanide and Clopidogrel have kept the momentum going. However, there has been a struggling demand to match the price expectations of several formulators, with the competition from within India rising at an alarming rate.

Considering future business growth, factors such as early entry as a preferable source for new products in cardiovascular and cancer therapeutic areas would further increase ISLLs share in the market it already dominates.

Pakistan

Pakistans pharmaceutical market has shown a downward trend since mid-2022 due to its rupee devaluation following the recent government reforms and the after- effects of the Russia-Ukraine war.

Ind-Swift in Pakistan

Despite the countrys unstable economy and some of the lowest dollar reserves, with several banks failing to establish Letters of Credit (LCs), ISLL has maintained a fair supply in this region. Ind-Swifts key developments from the earlier years have continued to yield for Ind-Swift in this country.

3) Latin American Market (LATAM)

The LATAM region is expected to post a CAGR of 9.7% over 2022-2026, although the impact of the COVID-19 pandemic and the ongoing Ukraine- Russia war have brought severe disruptions in the pricing.

The active pharmaceutical market in the LATAM region has been shaped by factors such as population growth, higher healthcare spending, increased research and development investments in the pharmaceutical industry, and the rise in chronic illnesses similar to the Asia Pacific region.

ISLL is still trying to retain its position in a volatile situation by placing its range of products to most of the geographical boundaries of this region, namely Brazil, Mexico, Argentina, Colombia, Peru, Chile, Uruguay, Paraguay, El Salvador, Costa Rica, Guatemala, Dominican Republic, and Honduras.

Brazil

It is the largest country in Latin America, with a population of over 212 million, and consequently has the biggest pharmaceutical market in the region. Their focus remains on its domestic industry and reduced reliance on imports and branded pharmaceuticals.

Ind-Swift in Brazil

Ind-Swift enjoys goods market share in Brazil by catering to almost all the local manufacturers with all the product ranges. A few products are going off the patent in 2024, which will further increase our strength in this market in terms of the new launches made by generic players. It is also to be noted that the number of diseases, including diabetes, CNS-related disorders, and respiratory diseases, is rising, which will spur demand for more complex medical treatments and increased demand for drug substances.

Mexico

It is the second-largest pharmaceutical market in Latin America, sharing its border and free-trade agreement with the United States. It is to be noted that Mexico has been bolstering its pharmaceutical industry with the indication of a rising trend in low-cost generics for numerous diseases, which has contributed to the countrys economy. Despite the market challenges posed by inflation and rising energy costs, Mexicos reliance on government- based tenders has been a hurdle to overcome.

Ind-Swift in Mexico

ISLL has retained its market share through non-tender and tender business associations. Furthermore, ISLL is actively involved in several new developments to reinforce the Companys presence in the country.

Argentina

The pharmaceutical sector in Argentina is presently ranked as the third largest market in the LATAM region in terms of volume consumption. This market is characterised by a high degree of concentration, with 20 laboratories accounting for 70% of the market.

The healthcare network is also operated through PROGRAMA DE ATENCION MEDICA INTEGRAL (PAMI), a comprehensive medical care program that consumes more than 40% of the total medicine requirement in the country and offers access to subsidies for aged groups.

Ind-Swift in Argentina

Despite facing challenges related to economic instability, such as the devaluation of the local currency over the past few years, ISLL has still been able to maintain a strong presence and market penetration through regular supplies of existing products and the development of new APIs.

Colombia

This nation is a burgeoning healthcare market driven mainly by public funding. The countrys healthcare infrastructure heavily depends on imports of active pharmaceutical ingredients.

The transformation of the Colombian healthcare system, including the formation of laws put forward by Colombias National Food and Drug Surveillance Institute (INVIMA), has considerably impacted the growth of the healthcare industry in a positive direction.

Ind-Swift in Columbia

The overall market share is not as large as the other markets in the LATAM region; nonetheless, it yields positive results, and competitive price offerings are key to winning with ever-rising competition.

4) MENA Region

The pharmaceutical market in the Middle East and Africa (MEA) has surpassed US$ 25 billion in value, exhibiting an impressive compound annual growth rate (CAGR) of 8%. This growth rate surpasses the expected global CAGR of 5.27%.

The driving numbers are primarily attributed to the strategic intent to further consolidate or diversify the portfolio based on various factors like epidemiological insights and pharmacoeconomic factors and to reach a larger target population across different countries within Africa and the Middle East. Middle East and Africa offer unique business opportunities because GCC countries make a sizeable contribution to the value market, have patent protection, and the business is driven by high-value branded and branded generic products.

While Africa significantly contributes to the volume business as most African countries are waived from Patent Protection, medicines as generic products are sold at a much lower price to improve access to medicine.

ISLL has successfully implemented penetration strategies, empowering the Company to secure a significant portion of the market share. This is attributed to the reliance of many local consumers on government tenders and the allocation of critical life-saving drugs.

Kingdom of Saudi Arabia (KSA)

The market size of the pharmaceuticals industry in Saudi Arabia reached close to US$ 8.6 billion in 2022, the largest in the region, accounting for more than 30% of the Middle East market, according to the Ministry of Industry and Mineral Resources.

There are approximately 50 registered pharmaceutical factories in the Kingdom with a coverage of 28% in terms of value and 42% in terms of volume, and exports amounting to Saudi Riyal 1.5 million.

Ind-Swift in Saudi Arabia

Considering this favorable circumstance, ISLL has experienced substantial growth in this region through a relentless supply of its products. Significant collaborations with prominent manufacturers like Tabuk and several developments with SPIMACO, Jamjoom, and SAJA will augment ISLLs market share.

Egypt

Egypt has continued its acceleration in terms of expansions and consumption in the pharmaceutical space. Boasting a revitalised and more robust institutional and regulatory framework, the pharma market in this region is growing at three times the regional average, stands second only to Saudi Arabia in terms of value within the Middle East & Africa (MEA) region, and takes top spot-on volume.

By leveraging "new technologies, implementing innovative marketing strategies, and revising existing regulations, Egypt can significantly increase the value of pharmaceutical exports to a projected US$ 5 billion by 2030," with imports majorly from India and China.

Ind-Swift in Egypt

ISLLs presence in this region includes several key supply contracts and development programs following Ind- Swifts new product pipeline.

Jordan

The pharmaceutical and healthcare sector is experiencing rapid growth, emerging as one of the fastest-growing industries in the country. This is attributed to its highly skilled and internationally certified workforce, advanced medical technology, and outstanding medical facilities.

The pharmaceutical industry alone contributes around 4% to the nations GDP. With more than 80% of the total pharmaceutical production being exported, it is the second-largest industry in Jordan.

Ind-Swift in Jordan

As the export sales of pharmaceuticals gradually recover following the pandemic-related restrictions, this market remains crucial for ISLL to expand its presence further.

Iran

Over the years, Iran has witnessed steady growth in the local manufacturing of pharmaceutical products. However, the share of the local manufacturers in the overall market value remains low due to the reliance on imported raw materials for medicine production.

Ind-Swift in Iran

In this region, ISLL primarily operates by exporting intermediates and active pharmaceutical ingredients (APIs).

Due to strict sanctions, business is presently slow. Although this market has excellent potential, scarcity of currency and routing payment through different channels have made the business challenging. Currently, efforts are being made to implement effective policies to mitigate the adverse impact of economic sanctions.

However, ISLLs business presence has been significantly hindered, and strategies to address this challenge are currently being evaluated.

Other markets

ISLL maintains its dominant position in other markets like Oman, UAE, Lebanon, Tunisia, Algeria, and Morocco, heavily relying on imported drug substances. The Companys success stems from its dependable supply chain and a comprehensive customer-specific strategy. ISLL focuses on developing and obtaining approval for new products as part of its long-term business strategy, ensuring future growth and profitability.

Human Resources

Ind- Swift as an organisation is constantly inspired by the contributions made by our employees.

Its our people who make our organisation what it is. Competent, talented, and empowered people of Ind-Swift have always played an important role in defining our path to success. We strongly believe that inspired and motivated people with a diverse set of skills when come together towards a common purpose, can make miracles happen.

Ind-Swift Group offers a conducive environment where people can learn and grow as well as explore opportunities We focus not only on the professional development of our people, but we also invest in raising their social consciousness. We offer an environment in which our employees can holistically develop themselves and aim for the one-of-a- kind opportunities available within the organisation.

We are one of the very few organisations where people have progressed from freshers to leadership positions all the while working with us. We are proud of our culture that fosters internal opportunities and are constantly welcoming anyone to join us and make a difference by virtue of their skills, abilities, and knowledge.

From time to time we upgrade our procedures, technologies, policies, and systems to match the competencies brought by new entrants in the organisation while simultaneously providing equal opportunities to them all to learn new skills. This keeps the organisation young, vibrant, energetic, and experienced at the same time.

HR policies, procedures, and protocols at Ind-Swift Laboratories Ltd are designed to acquire, maintain, and develop the best possible talent in the best possible way. Our policies are designed most scientifically after carefully reviewing the internal and external environment of the organisation. Our policies aim to establish the most modern HR practices in the workplace.

Thats why we are awarded "North Indias Best Employer" by the World HRD Congress in their 16th Annual Employer Branding Awards.

We strive to maintain our position of the best employer, best supplier, and best manufacturer of pharmaceutical products, now and always.

Financial Performance (based on Consolidated Financials)

Ind Swift reported a good holistic performance registering a strong growth at the topline and robust improvement in profits and profitability.

The uptick in sales volumes from domestic and international clients resulted in a 16.23% growth in Revenue from Operation from C1038.73 crore in FY22 to C 1207.31 crore in FY23. The topline spurt was accompanied by an increase in EBITDA from C238.22 crore to C256.97 crore over the same period.

While the interest liability for the year dropped marginally from C95.55 crore in FY22 to C92.17 crore in FY23, the provision for depreciation dropped considerably from C 131.04 crore to C57.36 over the same period.

The Profit after Tax increased from C (2.15) crore in FY22 to C47.60 crore in FY23 after expensing off an exceptional loss of C26.65 crore in FY23. Net Cash Flow from Operations also increased from C150.27 crore in FY22 to C194.62 crore in FY23.

Shareholders Fund increased from C404.48 crore as on March 31,2022 to C498.52 crore owing to addition of business surplus to the General Reserve. Total debt dropped from C952.48 crore as on March 31,2022 to C861.54 crore as on March 31,2023. The net debt-equity strengthened from 2.35 to 1.73

The Company expects to sustain its momentum in the current year with a focus on enhancing business profitability and strengthening liquidity to further deleverage the organization.

Significant changes (i.e. change of 25% or more as compared to the immediately previous financial years) in Key Financial Ratios, along with explanation are as under:

Particulars 2022-23 1 2021-22 Change Reason for change
Debtors Turnover Ratio 2.51 2.34 7.40% N.A.
Inventory Turnover Ratio 2.78 2.89 3.69%
n.a.
Interest Coverage Ratio 2.97 2.60 14.19% N.A.
Current Ratio 3.14 3.22 2.39%
n.a.
Debt-Equity Ratio 1.73 2.35 26.61% Due to increase in profit and decrease in debt this year as compared with the last year
Operating Profit Margin (%) 0.21 0.23 7.19%
n.a.
Net Profit Margin (%) 3.94 -0.21 NA Due to profit in this year as compared to loss in last year
Return on Net Worth (%) 9.55 -0.53 NA

Internal control & its adequacy

At Ind-Swift, we are cognizant of any risk arising out of internal and external factors. On account of a sound internal control system, we are vigilant regarding the evaluation of risks and hindrances in achieving our business goals. There are adequate checks and balances inbuilt in the processes along with diligent financial and operational reporting. In order to strengthen the Internal Control architecture, the Company is using ERP (Enterprise Resource Planning) packages with built-in controls. The deployment of ERP technology has resulted in the timely generation of financial reports, this in turn facilitates timely and in-depth audit of control mechanism, legal, regulatory, and environmental compliance. Further, the scope of Internal Audit also includes the periodic review and appraisal of internal controls and redressals of any shortcomings in the process. Finally, the entire internal audit and the control mechanism are under the surveillance and custodianship of the Board of Directors.

Risk Management

Numerous opportunities and hazards are presented by the external environment in which Ind-Swift operates, which the Company is ready to manage proactively.

The Board and leadership team of Ind-Swift put forth substantial effort to reduce risks that can interfere with the smooth operation of the business. This explains why a strong framework for risk management was developed to address strategic, financial, operational, and environmental risks.

The Companys risk management framework establishes standards to guarantee the Business Models sustainability. Its strong risk governance framework examines risk types as well as their likelihood and importance on the run. The risk management committee closely coordinates the development of plans for risk mitigation for potential business impacts.

Cautionary Statement

The Management Discussion & Analysis Report may contain certain statements that might be considered forward-looking within the meaning of applicable securities, laws, and regulations. These statements are subject to certain risks and uncertainties. Actual results may differ materially from those expressed in the statements as important factors could influence the Companys operations such as Government policies, tax laws, and political and economic development.