suven life sciences ltd Management discussions

LOBAL it showcased a better-than-expected adaption to the global crisis owing to the Russia-Ukraine war. In 2022 the world output managed to show immense resilience, posting a GDP growth of 3.2%.

While the first half remained muted with recessionary winds prevailing over developed economies, the second half marked resurgence. Economic growth picked up in the third quarter of 2022 with strong labor markets, robust household consumption and business investment. Persistent inflationary headwinds were controlled as central banks unleashed a slew of measures which successfully reigned inflation. Developed economies like United States and the Euro-Zone showed robust growth in the years second half.

Going forward, growth in world output is expected to slow down a little to 2.8% in 2023 considering the impact of the global crisis and inflationary pressures. The restrictions and covid-19 outbreaks in China dampened economic activities. But Chinas re-opening post Covid restrictions paves the way for rapid rebound in global activity. India remains a bright spot and along with China it is expected to account for half of global growth.

Despite the global slowdown Indias economic growth rate has been stronger than many peer economies. Indias GDP grew by 7.2% in 2022-23. Robust private consumption and heightened government investment in capital expenditure provided the much needed impetus to the Indian economy. This trend is expected to continue for the next 2-3 years. This optimism is platformed on two realities:

According to the Centre for Monitoring Indian Economy (CMIE), new projects worth H6 trillion were announced in the December quarter which will take shape in FY24. This is a 44% increase compared to the previous year

The Union Budget has provided for more thanRs10akh crore towards infrastructure creation which is the largest budgetary allocation towards infrastructure ever in the history of the nation

The industrial sector growth remained muted at 5.1% in FY23 owing to multiple global factors. On the _ip side India registered a significantly strong growth in exports which showcases its increasing relevance in global activity. Government revenue scaled significantly to provide decent leg-room for capital expenditure.

As the nation steps into FY24, GDP growth is estimated between 6-6.5% - a little lower than FY23 owing to considerable global risks which could weigh on the nations economic progress.

T^HE pharmaceutical space has experienced a huge transformation with the introduction of new technologies, cost-e_ective and more efficient manufacturing approaches. While the world was hit by the pandemic over the last three years the wider trends on the use of medicines continue to remain unchanged.

The pandemic prompted the use of medicines to grow sharply in 2021 and then plateaued in 2022 as some of the usage was related to temporary shifts in demand referred to as stockpiling. Latin America and Eastern Europe represent two of the fastest growing regions in terms of medicine spending globally. The per capita use of medicines is projected to grow in most regions except Africa and the Middle East where all volume increases are driven by population growth.

Chronic diseases continue to impact millions of lives and therefore better clinical research is required. The two leading global therapy areas that are oncology and immunology are forecasted to grow 13-16% and 3-6% CAGR respectively through 2027. In the last five years, a new wave of rare disease neurological treatments, including dozens with orphan designations, have been approved; other diseases with larger populations such as migraine, depression and anxiety have also seen a range of new treatments approved and launched. In the next five years new launches are expected to include important clusters in neurology including rare diseases.

R^ESEARCH and development in the pharmaceutical industry is a major driver in pushing medical advances to the market. The pharmaceutical industry is R&D intensive and is driven by a number of complex factors. These include growing requirements to obtain market approval, which have increased clinical trial costs, and an ever-increasing base of effective drugs that has shifted efforts to drugs for more complex conditions.

Clinical trial activity showed resilience even as the pandemic stretched through 2022, with a 1% decline in a non-COVID trial activity over 2021 but a restoration of pre pandemic growth rates with an 8% increase over 2019.

About drug discovery

Drug discovery is the process through which potential new medicines are identified. It involves a wide range of scientific disciplines, including biology, chemistry and pharmacology. The Drug Discovery process is a very long process that can take up to 13 years. The Early Drug Discovery process typically starts by screening for potentially active compounds. These compounds must have a therapeutic effect on the intended disease, and after identifying them, testing for safety and effectiveness begins. Typically, only 1 out of every 5,000 drugs make it to the market approval stage. Moreover, out of 5,000 and 10,000 drug candidates, only 250 make it to pre-clinical testing. The journey of discovering a new drug is estimated to cost around US$2.6 billion, as stated by a study performed by the Tufts Center. Beyond just the large investment needed to produce a new drug, the process has also become significantly more cumbersome as regulatory standards and requirements have become increasingly exacting. In addition, the post-marketing monitoring and development costs are said to be from US$312 million dollars, boosting the entire life cycle of Research and Development to three billion per drug.

SOURCE: https://blog.biobide.com/the-drug-discovery-process

New drug approvals in 2022 In 2022, US FDAs Center for Drug Evaluation and Researchs (CDER) approved 37 new drugs never before approved or marketed in the U.S., known as "novel" drugs. 20 of 37, or 54% of the novel drug approvals, were for rare diseases.

It also approved previously approved drugs in new settings, such as for new indications and patient populations. These approvals, spanning a wide range of diseases and conditions, will help many people live better and potentially longer lives.

The 2022 actions, both novel drug approvals and drugs approved in new settings, target diseases and conditions such as:

•Infectious diseases, including COVID-19, HIV, smallpox, in_uenza, and H. pyloriinfection, a bacterial infection in the stomach

• Neurological conditions, such as amyotrophic lateral sclerosis and spinal muscular atrophy

• Heart, blood, kidney, and endocrine diseases, such as type 1 diabetes and type 2 diabetes, a type of anemia, types of kidney impairment, and chronic weight management

• Autoimmune, inflmmatory, and lung conditions, such as inflmatory bowel disease, nutritional defiiencies, lupus nephritis, arthritis, eosinophilic esophagitis (a chronic infammatory disorder), and psoriasis

• Diffrent types of cancers, such as lung cancer, prostate cancer, types of breast cancer, a rare overgrowth syndrome known as PROS, and melanoma

SOURCE: https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2022

Generative AI in drug discovery The generative AI in drug discovery market refers to the market for the uses of generative artificial intelligence technologies in the drug discovery process. Generative AI is a type of machine learning that involves the formation of new data like new molecules, based on patterns learned from existing data.

In the context of drug discovery, generative AI algorithms can be trained on large databases of known drug molecules and their properties to create new compounds that are predicted to have therapeutic effects.

According to Market Research. Biz, the generative AI in drug discovery market size is projected to surpass around USD 1,129 million by 2032, and it is poised to reach a CAGR of 27.1% from 2023 to 2032. The market was only USD 109 million in 2022.

SOURCE: https://www.businessupturn.com/brand-post/ generative-ai-in-drug-discovery-market-size-usd-1129-mn-expands-steadily-at-a-cagr-of-27-1-by-2032/

C^ENTRAL nervous system diseases, also known as central nervous system disorders, are a group of neurological disorders that affect the structure or function of the brain or spinal cord, which collectively form the central nervous system.

Advancements in diagnostics and therapeutics of central nervous system (CNS) diseases are expected to increase the treatment rate globally. The CNS therapy growth will be driven by an increase in geriatric population and a substantial rise in CNS disorder cases such as neuromuscular diseases, degenerative diseases, Alzheimers disease, Parkinsons disease, multiple sclerosis, infectious diseases, mental health issues, anxiety disorders, bipolar disorder, and depression (owing to a high-stress lifestyle currently in vogue).

In the last five years diseases with larger populations such as depression and anxiety have seen a range of new treatments approved and launched. Technological advancement in genomics, biomarkers, diagnostics and/or regenerative medicine, combined with the introduction of disruptive digital technologies are changing the fundamentals of CNS innovation.

Recently, scientists have reviewed the effectiveness of nanotechnology-inspired EV (Extracellular vesicles) systems for therapeutics and diagnostics of CNS diseases. Research has shown that EVs play an important role in several physiological processes, including neuronal-glial metabolic exchange, neural plasticity, progression of brain pathologies (e.g., stroke and tumors), brain homeostasis, and neuromuscular integrity. The evidence strongly supports the application of EVs as potential diagnostic and therapeutic agents..

In the changed post COVID-19 business landscape, the global market for CNS Therapeutics estimated at US$114.9 billion in the year 2022, is projected to reach a revised size of US$199 billion by 2030, growing at a CAGR of 7.1% over the period 2022-2030.

Neuro-degenerative diseases is projected to record a 7.7% CAGR and reach US$75.9 billion by the end of the analysis period.

Increasing prevalence of CNS Disorders

According to WHO, one in every eight people in the world has some kind of mental illness. Similarly, according to WHO, depression is the leading cause of disability, accounting for more than 264 million cases as of January2020. It also stated that approximately 15% of individuals aged 60 and above su_ers from mental illness, thus accounting for 6.6% of the disability index for this age group. Hence, rise in the incidence of CNS disorders has compelled key pharmaceutical players to undertake extensive market development in this sector.

In addition, the growing prevalence of neuro-degenerative disorders, such as Parkinsons disease, Alzheimers disease, ALS, and HD, is expected to boost market growth. According to WHO, epilepsy accounts for around 13million disability-adjusted life years and is accountable for more than 0.5% of the global disease burden.

The lifetime overall prevalence of epilepsy is 7.6 per 1,000 persons and active prevalence of the disease is 6.38 per1,000 persons.

Increasing incidence of Alzheimers disease in elderly people is expected to fuel market growth. According to WHO, globally, approximately 50 million people have dementia and about 10 million new cases are reported every year. Furthermore, according to Alzheimers Association, approximately 13.8 million people aged 65 years and above are estimated to suffer from Alzheimers dementia by 2050. It was projected that about 5.8 million people in the U.S. aged 65 and above were living with Alzheimers dementia as of 2020. Among neuro-degenerative diseases, Alzheimers disease is becoming the most common cause of death and a common cause of physical disability. The disease is most common in women as compared to men.

North America held the largest share of CNS therapeutics market. Presence of a highly developed health care infrastructure coupled with better reimbursement policies and high awareness regarding available novel treatment options are anticipated to drive the market growth. The growing incidence of mental and neuro-degenerative diseases, such as multiple sclerosis, Alzheimers disease, Parkinsons disease, & epilepsy, is fueling the demand for CNS therapeutics in the region. For instance, according to the National Library of Medicine, about 2.8 million people were diagnosed with multiple sclerosis worldwide in 2020, out of which around 20% live in the North American region.

ABOUT THE COMPANY

W^E are a bio-pharmaceutical company, focused on discovering and developing novel pharmaceutical products, for CNS disorders using G Protein-Coupled Receptor targets. Our focus has been on discovery and development of innovative molecules targeting diseases and areas, which has undiscovered medical treatment opportunities.

The Company singularly focuses on development of New Chemical Entities (NCEs) molecules for CNS diseases such as Alzheimers, various forms of Dementia, Narcolepsy, Major Depressive Disorder (MDD), Attention

Deffient Hyperactivity Disorder (ADHD), Huntingtons disease, Parkinson,Bipolar disorder and different forms of neuro-psychiatry disorders, gastro and pain.

Incorporated in the year 1989 as a bulk drug manufacturer in the pharmaceuticals industry, initially the Company was focused on the service-oriented business model Contract Research and Manufacturing Services ("CRAMS"), aligned with global pharmaceutical and biotechnology companies and subsequently diversified in discovery and development of innovative molecules targeting diseases.

We started the drug discovery business in the year 2003 and incorporated our wholly owned subsidiary Suven Neurosciences, Inc. in the year 2015 in New Jersey, USA. Suven Neurosciences, Inc. a Delaware Company, is a clinical-stage bio-pharmaceutical company focused on acquisition, development and commercialisation of novel therapeutics for the treatment of neuro-degenerative disorders.

FINANCIAL PERFORMANCE

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