Dear Shareholders,
Fiscal 2024-25 was marked by robust growth for Sun Pharma as the
Company continued to make progress towards its strategic goals and improve its
capabilities.
As we navigate the evolving landscape of the global pharmaceutical
industry, we remain firm in our commitment to growth and profitability while proactively
addressing the increasing risks faced by our Company and the industry.
Over the past few years, Sun Pharma's operating environment has
undergone a remarkable change, prompting us to evolve in step with the shifting dynamics.
Early in the decade, the COVID-19 pandemic disrupted medicine availability during a time
of critical need, which led us to redesign our supply chains and strengthen local
sourcing. Over time, significant price erosion in parts of generic business, including the
US, has led us to adopt a more conservative approach to those markets. As healthcare
budgets continue to soar across the world, pharma buyers across both Developed and
Emerging Markets are seeking greater value for their medicine purchases.
In response, we are fortifying our branded portfolio with products that
enhance the standard of care' while remaining strongly cost-competitive in the
generics business.
Some of the challenges cited above are likely to remain or even
escalate in the future. Due to increasing geopolitical uncertainties, reliable supply of
safe medicines has become high priority for nations worldwide, leading to demand for
on-shoring or near-shoring of pharma manufacturing. It is likely that price pressures on
drug manufacturers may further increase. In this dynamic environment, our endeavour has
been to stay competitive by continuously offering compelling value to our patients,
prescribers and buyers.
A characteristic feature of the pharma industry is that it is highly
regulated, with varied regulations across countries adding to the complexity of
operations. Regulatory changes can impact the way we operate in any geography, making it
imperative for us to remain agile. Given that we operate over 100 countries, with a
portfolio comprising both innovative and generic products, our readiness to adjust to
changes in the external environment is a distinct advantage that has served us well and
should remain a source of competitive advantage in future.
The Company has evolved alongside its expanding operations, with a
demonstrated ability to manage and grow multiple pharma businesses simultaneously. This
diversification has made us less dependent on any geography, event or specific product.
Further, within each of our businesses, our focused efforts to minimise risks have
positioned us for sustainable growth.
During FY25, our global consolidated revenues grew by 9.0% to I 520
Billion, while EBITDA grew by 17.3% to
I 153 Billion. Adjusted net profit was up by 19.0% to I 120 Billion.
Our return ratios also continued their upward trend.
Our Global Specialty or Innovative Therapies business continued on its
growth trajectory during the year. The contribution of Global Specialty to the
consolidated revenue increased from 18% in FY24 to 20% in FY25.
Over the last few years, we have made substantial investments to
enhance our capabilities in the Global Specialty business. This includes senior-level
hires across various functions and the strengthening of our in-house clinical development
capabilities. Our Specialty R&D spend increased to US$ 154 Million in FY25, reflecting
our commitment to innovation. Having reached a critical mass, we are poised to increase
our investments to scale up in the Innovative Therapies segment.
During the year, our market share continued to improve across
geographies, including in India. We remain dedicated to serving patients and prescribers,
a principle that has guided us since inception. Our recent initiatives include expanding
our Global Specialty pipeline with new product introductions and increasing our field
force in India and other Emerging Markets.
Operational Performance
We lead the Pharmaceutical market in India in value as well as
prescription volumes as per AIOCD-AWACS data. In FY25, our India Formulation sales reached
I 169 Billion, up by 13.7% and accounting for about 33% of overall revenues. According to
AIOCD-AWACS, our market share improved to 8.3% on a Moving Annual Total (MAT) basis ending
March 2025 against 8.0% during the previous period ending March 2024. Our growth in India
is primarily driven by higher volumes and new product launches. We have consistently
demonstrated volume-led growth in comparison to the industry, which in turn, is primarily
growing through price increases.
As per Specialty Market and Sales Resource Centre (SMSRC) data for MAT
February 2025, Sun Pharma ranks #1 by prescriptions across 13 different classes of
doctors.
We sustained our momentum in India with 42 new product launches during
FY25. We undertook field force expansion in India during the reporting year, adding 8% to
our existing field strength. Our India field force expansion, implemented in successive
rounds over the last five years, has helped us declutter our portfolio and expand our
presence in Tier II and Tier III towns.
In the US, our revenue grew by 5.8% to I 162 Billion, accounting for
approximately 31% of our consolidated revenues. Our growth in the US has been driven by
Specialty sales, with several products gaining sustained traction. The
Generics business in the US, on the other hand, was adversely affected by the ongoing
compliance issues at our manufacturing facilities, as well as additional competition in
certain products.
Our sales in Emerging Markets grew by 9.2% to I 94 Billion,
contributing ~18% to our consolidated revenues. Our core markets, including Romania and
Brazil, have continued to do well, recording strong double-digit growth in local currency
terms.
Sales in the Rest of World (RoW) markets grew by 6.7% to I 72 Billion,
contributing ~14% to the consolidated revenues. Our performance was impacted by price cuts
in Japan in the early part of the year. In RoW, growth in the Specialty business
compensated for pricing pressure in the Generics business.
Global Specialty Business Performance
The Global Specialty revenue recorded a strong 17.1% growth to reach
US$ 1,216 Million during FY25. Key products such as Ilumya, Winlevi, Cequa and Odomzo
continued to perform well globally. FY25 also proved to be an eventful year in terms of
enhancing our Specialty pipeline.
At present, a significant portion of our investment in the Specialty
business has not started to yield revenues. Our spend on the acquisition of Concert
Pharmaceuticals and Checkpoint Therapeutics will only provide
commensurate returns over a longer time-frame.
These long term returns are not assured merely by paying up the
transaction value, as these investments have given us ownership of pre-revenue assets. We
believe that when such long-term bets pay off, they have the potential to transform the
business at scale. We shall therefore continue to allocate capital for such investments
while remaining focused on driving growth in our core businesses and retaining our
competitive advantage across each of them.
In May 2025, our Company announced completion of the acquisition of
Checkpoint Therapeutics, Inc., which is a focused on developing novel treatments for
patients with solid tumour cancers. With the acquisition, Sun Pharma has added
Unloxcyt (cosibelimab-ipdl) the first and only US FDA-approved anti-PD-L1
treatment for metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) to
the Company's global onco dermatology franchise.
In October 2024, Sun Pharma announced a globally exclusive agreement
with Philogen for the commercialisation, licensing, and supply of Fibromun (L19TNF), an
innovative anti-cancer immunotherapy. Sun Pharma will be responsible for the global
commercialisation of Fibromun, currently in registration trials for the treatment of soft
tissue sarcoma and glioblastoma.
In July 2024, US FDA approved Leqselvi, an oral Janus Kinase (JAK)
inhibitor for the treatment of severe alopecia areata. In April 2025, the US Court of
Appeals for the Federal Circuit vacated the preliminary injunction that had restricted the
medicine's market launch.
In June 2024, the European Medicines Agency (EMA) validated the
submission of the Marketing Authorisation Application (MAA) for Nidlegy (melanoma and
non-melanoma skin cancers).
Key Products from our Global Specialty-marketed Portfolio
ILUMYA/ILUMETRI is an IL-23 inhibitor used in the treatment of
adults with moderate-to-severe plaque psoriasis, who are also candidates for systemic
therapy or phototherapy. We market the product ourselves in several countries, including
the US, Canada, Australia, Japan, and through our partners in Western Europe and China.
WINLEVI is a first-in-class topical androgen receptor inhibitor,
approved by the US FDA, for the topical treatment of acne vulgaris in patients above the
age of 12.
CEQUA, indicated for topical ophthalmic use, is the first and only
US FDA-approved cyclosporine treatment delivered with NCELLTM technology. This product
offers the highest concentration of cyclosporine for ophthalmic use approved by the US
FDA, and is indicated to increase tear production in patients with dry eye, an
inflammatory disease that afflicts more than 16 Million people in the US.
ODOMZO, a hedgehog pathway inhibitor, is indicated for the
treatment of adult patients with locally advanced basal cell carcinoma (laBCC) that has
recurred following surgery or radiation therapy, or for those who are not candidates for
surgery or radiation therapy. Odomzo is available in the US and several other
international markets.
LEVULAN KERASTICK+BLU-U combines a powerful 20% aminolevulinic acid
HCl (ALA) topical treatment with blue-light precision while limiting exposure to the
deeper tissue. It is the only Photodynamic Therapy indicated for the treatment of
minimally-to-moderately thick actinic keratoses of the face or scalp, or actinic keratosis
of the upper extremities.
Research & Development (R&D)
Our R&D investment for FY25 stood at I 32 Billion, or 6.2% of the
overall sales. During the year, we filed approximately 280 formulation dossiers globally.
Out of total R&D spend, Sun Pharma spent 40% on Specialty or
Innovative R&D. Sun Pharma's Specialty R&D pipeline comprises seven
candidates in various stages of clinical trials. Our pipeline in advanced clinical stage
or post-approval stage is made up of the following products:
LEQSELVI, a US FDA-approved JAK inhibitor indicated for
the treatment of adults with severe alopecia areata. Open Label Extension studies for
Leqselvi are ongoing.
UNLOXCYT, a US FDA-approved anti-PD-L1 treatment for
advanced cutaneous squamous cell carcinoma. Unloxcyt further bolsters our innovative
portfolio in onco-derm therapy.
NIDLEGYTM is filed with EMA for the treatment of locally
advanced fully resectable melanoma. NIDLEGYTM is also being investigated for the treatment
of locally advanced melanoma and for the treatment of high-risk basal cell carcinoma and
other non-melanoma skin cancers. Sun Pharma is the partner for commercialisation of the
candidate in EU, Australia and New Zealand.
Our currently marketed product, ILUMYA , is undergoing
Phase-3 clinical trials for additional indication of treatment of psoriatic arthritis.
Topline data for the studies is expected during the second half of CY25.
FIBROMUN consists of the L19 antibody fused to tumour
necrosis factor (i.e.L19TNF). Late-stage clinical trials with registration potential are
going on in soft tissue sarcoma and glioblastoma.
cGMP Compliance
Adherence to global cGMP standards is a key priority for us, and we
keep a relentless focus on 24x7 compliance to ensure uninterrupted supplies to our
customers and patients worldwide.
We are facing US FDA compliance-related issues at three of our
facilities. These include an import alert at the Halol facility, receipt of non-compliance
letter for the Mohali facility, both during FY23. Additionally, our Dadra facility was
accorded an Official Action Indicated (OAI) status in FY24 . Besides these three, all our
facilities remain compliant with global regulatory standards, including those of US FDA.
We have completed the implementation of Corrective and Preventive Action (CAPA) in the
Halol facility, which is currently awaiting US FDA inspection, and we are in the process
of implementing CAPA at the Mohali and Dadra facilities.
Sustainability
Sustainability has become pivotal in building a more equitable,
environmentally conscious, and sustainable future for all. Sustainability is not just a
commitment but a shared responsibility that calls for decisive action. Our approach
focuses on embedding sustainable practices into our operations to deliver long-term value
for all stakeholders.
I am happy to let you know that Sun Pharma has been included in the
S&P Global Sustainability Yearbook 2025, earning its place among the top 5% of
pharmaceutical companies assessed by S&P globally for this Yearbook, which recognises
companies within their respective industries that have demonstrated strong performance in
corporate sustainability.
We have an unwavering focus on combating climate change. Key focus
areas include improving energy efficiency, increasing the share of renewable energy,
strengthening water conservation, and advancing sustainable waste management. Attracting,
retaining and nurturing a highly diverse and skilled workforce are also key focus areas
for us. Our Corporate Social Responsibility (CSR) initiatives for the local communities
are centred around areas like healthcare, education, water & sanitation, rural
development, and environmental conservation. We implement focused and socially responsible
initiatives with the objective of promoting the holistic development of our local
communities. Our comprehensive corporate governance framework underpins our commitment to
upholding the highest standards of ethical governance and enabling sustainable outcomes
for all our stakeholders.
We are conscious of our responsibility towards the future of our
planet, and it demands increased focus on climate resilience and responsible business
practices. We will continue to endeavour to integrate ESG into our business strategy.
Enhancing Efficiency and Impact
Our focus has always been on sustainable cost reduction via technology
interventions and process enhancements. We are also directing our efforts towards reducing
working capital deployment across our businesses. Sustained efforts are being made to
further improve our manufacturing efficiency, optimise our production footprint, and
reduce overall fixed costs.
Net Cash and Deployment Opportunities
With a strong net cash position of approximately US$ 3.1 Billion as of
March 31, 2025, we are well-positioned to explore inorganic growth opportunities,
including but not limited to strengthening our Global Specialty portfolio.
Overall Outlook
We anticipate mid to high single-digit consolidated topline growth in
FY26, and expect our Global Specialty business to continue on its growth path. Our R&D
spend in FY26 is likely to be in the range of 6%-8% of sales, with increased spending
expected on Specialty products.
Top Priorities for FY26
Enhance compliance across our manufacturing operation, and work
towards achieving full regulatory resolution at the three facilities facing US FDA action
Ensure the readiness for our upcoming launches, namely LEQSELVI
and UNLOXCYT
Advance our pipeline of Global Specialty products
Prepare the business for potential disruptions arising from
tariffs and geopolitical issues
Ensure supply chain continuity and simultaneously focus on
inventory optimisation
Enhance IT systems to facilitate business operations and ensure
security and digital transformation
Embed sustainability practices across our operations as per our
clear and actionable targets to achieve our sustainability goals
Continued focus on cost and operational efficiency
Sustain the positive momentum in improving overall return ratios
Our growth over the past four decades would not have been possible
without the Company's dedicated workforce. In FY25, Sun Pharma employed more than
43,000 people worldwide. We continue to work towards ensuring that our Human Resource
management systems keep pace with this expansion. It is our constant endeavour to treat
all our employees in a fair and equitable manner.
We are grateful to our Board of Directors for their guidance and
support.
Your support to us as a shareholder is of vital importance, and we hope
that you will continue to repose your confidence in us in the future.
Regards,
Dilip Shanghvi |
Chairman and Managing Director |
Sun Pharmaceutical Industries Limited |