We believe in our leadership potential and have developed a robust
strategy to grow and consolidate our position , in the industry
Dear Shareholders
The global pharmaceutical industry is all set to witness the best and
the worst of times, depending on the way we look at it.
Generic companies are about to enter a phase of incredible opportunity
with the imminent patent cliff when drugs worth USD 78 Bn will go off
patent. And in the innovation space the prospects for high-value
collaborations with big pharma on research projects are increasingly
plausible as pharma giants look to cut research costs and fortify their
R&D pipelines through tie-ups with other organizations. All this augurs
well for Glenmark as we have the capability to capitalize on both these
opportunities.
At the same time, however, the business environment for the industry
has become particularly exigent. The generics space is witnessing
significant value erosion with growing competition. While this market
was hitherto the domain of pure play generic companies, we now see
innovator companies - those that have so far built fortunes by
discovering new drugs - climbing onto the generics bandwagon as they
face an increasingly unpredictable future in the pursuit of a new
blockbuster drug. And then we have the giants of the generics industry
who are now looking to move up the value chain by investing in
innovation and differentiated products to bolster the sustainability of
their business model. Clearly the lines between innovator companies and
generic companies have blurred and this, alongwith increasing
regulatory hurdles and pricing pressure is adding to the complexity of
our business.
But there is an upside to this. Challenges help to separate the true
leaders from the rest of the pack. We at Glenmark believe in our
leadership potential and have developed a robust strategy to grow and
consolidate our position in the industry.
The Glenmark Story So Far Looking back over the last decade, Glenmark
has grown 14 fold in revenues and nearly 26 fold in profits, a
remarkable achievement by any standards. While growing the business at
a remarkable pace, we have not lost sight of our goals. We have
remained focused on building a truly world class innovative company and
at the same time developing strong capabilities in our generics
business.
We have remained focused on building a truly world class innovative
company and at the same time developing strong capabilities in our
generics business
During the last couple of years our primary objective was to ensure
that every operating region is self sustaining from a funding stand
point. In this financial year, we have come close to this goal and
expect it to further strengthen that position in FY*12.
For the financial year, we also managed to register commendable sales
and profit growth for the group. Glenmark grew net sales by 19 %* and
net profit increased by 38 %\ The net sales growth was spurred by
India, US and API business.
Glenmark grew net sales by 19 %* and net profit increased by 38 %*
Generics Business
In the pure generics space, we have done well with the business growing
by 19 %. In the US, where your Company continues to differentiate
itself by focusing on niche/difficult- to-manufacture products that are
more profitable, sales grew by 20 %.The US generics business received
22 ANDA approvals, the highest for an Indian company in this financial
year. We also became the first Indian company to receive approvals for
a basket of oral contraceptive/hormone products, a category that has
significant potential. As of now, we have six approvals in this
segment. While we launched 18 products in the US last year, the impact
of these launches will be reflected in the current financial year.
US generics business received 22 AND A approvals, the highest for an
Indian company in this financial year
Our US generics strategy also includes a basket of strategic Para IV
filings. Your Company has now settled all the four Para IV challenges
where Glenmark was the sole first-to-file. Hence, we are now sure that
we will have atleast one Para IV opportunity every year for the next
three years providing us clear visibility in terms of sales.
During the year, we did suffer a setback on the Para IV filings front
with the jury verdict on the cardiovascular drug Tarka in Jan11 which
went against us. Earlier, in May10 the judge had overruled a
preliminary injunction filed by the innovator, paving the way for the
launch of the product at risk. The matter is still pending in the US
courts and the judge has yet to take into account Glenmarks defense
that the patent is invalid for double patenting, for which the jurys
verdict was only advisory. Glenmark believes that the innovators
patent is not valid and we are confident that the court will consider
our view.
Glenmarks generics business also benefitted from the excellent growth
in the API segment. The growth is the result of a change in our
strategy - we have shifted our focus from semi-regulated markets to
regulated markets. This has helped us decommoditize and grow the API
business faster and more profitably.
Specialty Business
The specialty business in India recorded good sales growth thanks to
new product launches in key therapeutic areas. Over the last few years
we have implemented a conscious strategy of emphasizing on power brands
and key therapeutic areas viz Dermatology, Respiratory and Oncology. In
addition, we will focus on one or two additional therapeutic areas
which will be specific to a region. This strategy has already started
bearing fruit in the Indian market and in the Rest of the World (RoW)
markets where we have just completed the implementation of this
strategy. We are confident that in this year, the RoW markets - which
saw a modest increase in sales last year - will record strong growth
rates alongwith the India business.
We have implemented a conscious strategy of emphasizing on power brands
and key therapeutic areas
Following the success of our transitioning exercise in India and the
RoW markets, the Central Eastern Europe (CEE) and the Latin American
region have also started reorienting the product pipeline to focus on
core therapeutic areas. The Brazil subsidiary has initiated steps in
this direction with the launch of a unique portfolio of cosmeceuticals
and a new range of oncology products. We feel that by leveraging our
expertise in the area of dermatology, respiratory and oncology these
regions will also be on the path of sustainable growth.
Innovation and Beyond
Our R&D business, which is without a doubt the crown jewel of the
Company, has an innovation pipeline that is stronger than ever before.
The purpose of our research efforts is to develop and bring to market
our own novel molecules in areas of unmet medical needs, which will
propel us into the league of truly successful innovative companies in
the pharmaceutical industry worldwide.
The purpose of our research efforts is to develop and bring to market
our own novel molecules in areas of unmet medical needs
By out-licensing GRC 15300, a novel molecule indicated for pain
conditions to Sanofi for USD 325 Mn and receiving an upfront payment of
USD 20 Mn, we have once again reaffirmed our capability of doing
research at the cutting edge.
The successful completion of the Phase III studies of our in- licensed
product Crofelemer in the US for HIV associated diarrhea is further
proof of this. The Phase III studies on Crofelemer will pave the way
for the launch of the first innovative product across 140 markets where
we have the exclusive marketing and distribution rights.
Meanwhile, we continue to bring novel first-in-class compounds to the
clinics and in this financial year we announced the discovery of two
novel compounds - a New Chemical Entity (NCE) and a New Biologic Entity
(NBE). Both are potential first-in-class molecules. The biologic
molecule GBR 401 is a monoclonal antibody (mAb) indicated for Leukemia
and Lymphomas. It is our first molecule discovered for oncology and
marks an entry into a very challenging area that is a big concern area
around the world.
At the same time, we are clear that if we are not first-in-class or
best-in-class we will not pursue the program. Thus we announced our
exit from the diabetes research area as the new regulations which have
come into the fore in the US will make researching diabetes molecules a
more prolonged and costlier exercise.
Quality
During the financial year, your Company began the process of putting in
place a global quality system which will enable us to service every
market with a global quality protocol. This is an intensive effort but
a proactive one from your Company. We envisage that in the near future
as governments demand the best for their citizens, we need to be
proactive and put such an initiative in place before legislation is
enforced.
Our Business and Society
While your Company continues to make sustained investments into its
business, I am proud to share our efforts at strengthening our
commitment to the environment and our engagement with society, all of
which indicates that your Company takes not just its business seriously
but also invests and takes pride in being a responsible corporate
citizen. The Company received ISO 14001 -the environment certification
for the formulations plant at Colvale, Goa. Simultaneously, the Company
continued its investment in upgrading its environment standards across
all plants.
Another major initiative is the Companys commitment to the community.
While in the past, Glenmark made substantial donations to various
causes, the Company has now decided to invest in specific areas where
it will make continuous investments. In the past year, Glenmark began a
number of projects which focused on sustainable livelihoods. All our
initiatives have been well received by the communities that we work
with and this is a matter of great pride for our organization. In this
financial year, your Company will invest in the area of child health
which is a global concern. In this financial year, we hope to adopt
about 300 villages in India where statistics of child mortality is the
worst in the country and we will facilitate a collaborative effort
between the social sector and the establishment to significantly
improve child health in these areas.
Future Outlook -
Looking forward, I am happy to say that we have put in place structures
for growth for the next two financial years and we have already begun
preparing for FY 14 and beyond.
In the short term, we will continue to build a pipeline that has a
strong focus in Dermatology, Respiratory and Oncology worldwide. This
will ensure sustained growth for the next few years at the branded
generics and generics fronts.
Our strategy for the long-term (beyond 2015) is to have a basket of
innovative molecules with high market potential. This is where our
drug development capabilities would put us in good stead. So while
there is talk that the generic pipeline will dry after 2014, I would
like to mention that your Company has initiated plans to enter new
areas that shall fuel its growth beyond 2015.
Our strategy beyond 2015 is to have a basket of innovative molecules
with high market potential
In addition to our novel R&D efforts, we are also building capabilities
in the bio-similars space and a global respiratory franchise.
Although regulators are still evolving with reference to biosimilars,
we are stepping up our efforts in order to capture this opportunity.
Bio-similars will definitely challenge generic companies as the
competencies for bio-similars is very different from manufacturing
generic medicines.
The focus for us is that we need to put in place structures that will
deliver us sustained growth year on year. While we continue our path
breaking work on the innovative R&D front with first-in-class novel
chemical and biologies entities. At the same time, we are building a
model that will enable the Company to grow year on year in the branded
generics, pure generics and the API space. Most importantly we would
like to grow profitably, thereby enhancing shareholder value at all
times. Our pursuit of launching the first innovative molecule by an
Indian company remains and we have taken a step forward by doing a
licensing deal in this financial year.
We remain committed towards becoming a leader in drug discovery
research and being among the leading generics companies in the world
and I am confident that with your support we will achieve our goals in
the not too distant future.
Regards
Glenn Saldanha
Chairman & MD
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