We have just seen a year of extraordinary challenges a year that haschanged our lives in different ways. The COVID-19 pandemic has created immense disruptionin the global economy and the healthcare sector.
The unpredictability remains and we expect that the coming year willcontinue to test our resilience and determination to navigate volatility.
As an organization it was apparent to us right at the beginning thatCOVID-19 was a one-of-a-kind situation facing humanity and our industry and its effectswould be far-reaching. We also realized that to succeed in such a business environmentorganizations needed to adopt a different mindset. Undoubtedly the tenets of doingbusiness in a post-COVID world are resilience adaptability and flexibility. Only withthese capabilities can an organization align itself to the changing reality and continueto create value for its customers and other stakeholders.
Our response to COVID-19 was unparalleled and it put us on par withother global pharmaceutical companies that worked against the clock to find treatmentoptions for COVID-19.
Our performance demonstrated our operational robustness and ability tocater to diverse patient needs in challenging situations. Our competitive advantage camefrom our timely action quick adaptation and purposeful innovation - with a firm focus onbusiness continuity. Every team and business function across Glenmark embraced agility inits way of working from the onset of the pandemic.
FabiFlu: Glenmark's timely response to the pandemic
Our oral antiviral FabiFlu (favipiravir) is a testament to the deepcapabilities that define brand Glenmark. In March 2020 the World Health Organizationdeclared the COVID-19 a global pandemic.
In less than three months Glenmark became the first pharmaceuticalcompany in India to receive emergency use authorization for FabiFlu. I am proud to saythat we ploughed through all challenges to ensure that our therapy reached more than 5million patients in India making the impact real tangible and timely. By April 2021FabiFlu had become the highest selling drug in the Indian pharma market amongst alltherapies.
Recalibration for a new reality
We demonstrated operational resilience and agility in our successfulclearing of virtual audits and in our introduction of digital tools to communicate withdoctors and sales staff.
Our collaborative mindset saw our Operations and Manufacturing teamsworking seamlessly round the clock to produce an uninterrupted supply of medicines forpatients around the world. Thus honoring our commitment to patients partners and thecommunity.
Our frontline and corporate functions further re- examined andrecalibrated their business models and worked in unison to achieve new milestones and setnew benchmarks of excellence.
Leading through innovation
Innovation is how we generate value. Our investments in R&D gobeyond launching generics and fuel development of innovative products that raise thestandard of care for diseases with significant unmet needs.
We launched a number of products in FY21. In addition to FabiFlu theother significant launch was Ryaltris (olopatadine hydrochloride and mometasonefuroate monohydrate) an anti-allergy nasal spray that is being marketed globally.Ryaltris sales continue to progress well in Australia South Africa Ukraine andUzbekistan. We have initiated launch in Russia and received marketing approval for launchin the Philippines.
We are entering into partnership agreements for the commercializationof Ryaltris in other countries and plan to launch it on our own in some markets.
Glenmark's novel patent-protected and globally- researched sodiumglucose co-transporter-2 (SGLT2) inhibitor Remogliflozin Etabonate(Remogliflozin) forthe treatment of type 2 diabetes continues to do well in India.
Furthermore Glenmark has received a positive response to the launch ofthe Remogliflozin + Vildagliptin fixed dose combination underthe brand names Remo V andRemozen V for adults with type 2 diabetes in India. The brands have gained a market shareof 37.9% in the SGLT/DPP4 market according to IQVIA Jan-March 2021 data.
Our specialty/innovative pipeline
GRC 17536 (TRPA1 antagonist) is a specialty asset being developed as anorally administered treatment for patients with painful diabetic peripheral neuropathy.
We announced the successful Phase 1 results of GBR 310 that suggestsimilarity in pharmacokinetic pharmacodynamic safety and immunogenicity profilesbetween GBR 310 and the reference product omalizumab marketed in the US under the brandname Xolair. We are in discussions with potential partners and plan to finalize a dealbefore initiating Phase 3 studies.
GRC 39815 (RORyt antagonist) is the company's respiratory pipelineasset that is being developed as an inhaled therapy for the treatment of mild to moderatechronic obstructive pulmonary disease (COPD). It is currently under Phase 1 clinicaldevelopment with a single ascending dose study in the US. The Phase 1 study is expected tobe completed in the next few quarters.
In oncology our pipeline molecule - GRC 54276 (HPK1 inhibitor) - isbeing developed as an orally administered immuno-oncology-adjuvanttreatment for patientswith solid tumors.
In the dermatology segment we are evaluating GRC 4039 (PDE4 inhibitor)as a topically administered treatment for patients with mild to moderate atopicdermatitis.
An impressive pipeline from Ichnos
Our biologics pipeline in Ichnos is gaining traction. In FY21 we madea strategic decision to refine the Ichnos pipeline by sharpening our focus on oncologybiologics based on BEAT our proprietary bi-/trispecific engineering platform andout-licensing our immunology assets.
The technology platform is enabling us to develop novel immune cellengagers and modulators in oncology. It will help us realize our mission to providebreakthrough therapies that will extend and improve lives and thereby write a new chapterin healthcare.
Ichnos' current multi-specific oncology pipeline consists of fiveprograms including a clinical-stage first-in-class T-cell engager ISB 1342thattargetsCD38 and CD3; and a preclinical-stage first-in-class CD38 x CD47 immune cellengager ISB 1442 which leverages multiple mechanisms of cellular cytotoxicity.
Additionally Ichnos is working to out-license two antibodies withpotential across a range of autoimmune diseases. ISB 830 (telazorlimab) an 0X40antagonist monoclonal antibody (mAb) is in Phase 2b trials for the treatment of atopicdermatitis. ISB 880 is a preclinical stage high-affinity IL-1RAP antagonist mAb that isbeing targeted for IND submission bythe end of fiscal year 2021-2022.
A positive performance
Despite multiple challenges our business has remained stable and isgrowing. Forthe year under review (2020- 21) Glenmark's consolidated revenue recorded anincrease of 2.8% to reach INR109439 Mn as against INR 106410 Mn overthe previouscorresponding period. Net profit stood at INR 9701 Mn in FY21 as against INR 7760 Mn inthe previous fiscal - a growth of 25%.
Glenmark stayed its course as one of the fastest growing companies inIndia with a growth of 14% versus the average growth rate of 6% in the Indianpharmaceutical market. Our prescription (Rx) business in India continued to drive marketshare in respiratory dermatology oncology and cardio-metabolics. Today Glenmark isranked 2nd in dermatology 3rd in respiratory medicine 6thin cardiology and is amongst the top 15 companies in the diabetes and oncology space inthe country.
The Glenmark Consumer Care (GCC) business maintained its lead with topbrands Candid LaShield and Scalpe. It is a matter of pride for us that in FY21Candid powder became the first GCC brand with sales of over INR 1 Bn (INR 100Cr+).
Broadening our global presence
In the fiscal year 2020-21 Glenmark received approval for 14 ANDAsthat comprised 10 final approvals and four tentative approvals. Today Glenmark is ranked15th in the US amongst generic companies (in terms of volume) and 17thin terms of total prescriptions. Our products fill about 83 Mn prescriptions each year inthe US and this number is expected to continue increasing annually.
Glenmark has built a strong presence across key markets in Western andCentral Eastern Europe. Our present geographies include the UK Germany the NetherlandsSpain the Czech Republic the Nordic countries Slovakia Poland and Romania. For thisfinancial year the European region signed 21 major contractsforin-licensing products.Restof theworld markets continue to be an emerging growth area. We have now expanded inregions such as Australia and Thailand.
Reorganizing to resurge
A strategic restructuring of the organization enabled us to build aleading focused and integrated pharmaceutical company powered by advanced therapyplatforms. We spun off our API business and biologics divisions into separatesubsidiaries to unlock their value and propel them into new growth trajectories.
Following the restructuring the company's flagship brand GlenmarkPharmaceuticals Ltd. continues to focus on generics branded and specialty/innovativeproducts. The API subsidiary (Glenmark Life Sciences) is expected to show robust growthwith the world looking at India to de-risk its supply chain for its API needs. IchnosSciences Inc. is Glenmark's US-based innovation biologics business that is working onexpediting the development of oncology and autoimmune medicines. All three entitiesoperate independently with separate management teams and Boards of Directors.
Glenmark Life Sciences is now separately listed on the Indian StockExchanges (BSE and NSE) under the ticker 'GLS'.
Glenmark will continue to forge ahead as an integrated innovation-ledglobal pharmaceutical company. It extends across the pharmaceutical value chain from APIto finished formulations harnesses technologies from complex chemistry to biologics andmakes products from affordable generics to value-added specialties and soon cutting-edgeinnovation.
We expect to see robust growth across major geographies and emergingmarkets. Our focus for FY22 comprises deepening our presence in existing geographies andexpanding our portfolio in new markets. We are also working on building a strong globalcompliance framework and investing in further automation across our manufacturing plantsto drive qualityand efficiency.
The long-term goal of Glenmark Pharmaceuticals is to move up the valuechain into complex generics specialty products and innovative products. We continue ourpresent focus on the key therapy areas of respiratory dermatology and oncology and aimto develop a strong regional presence in select therapeutic areas.
In India we expect to drive our market leading growth by centering ourefforts on our key therapy areas expanding our reach by utilizing new ways of digitalcommunications and growing our portfolio of OTC products.
Glenmark signed an exclusive partnership with Canadian biotech SaNOtizeResearch & Development Corp. to manufacture market and distribute its novelpreventive breakthrough Nitric Oxide Nasal Spray (NONS) for COVID-19 treatment in Indiaand other Asian markets. Glenmark's FabiSpray is an effective antiviral treatment toprevent COVID-19 transmission shorten its course and reduce symptom severity. We expectto complete Phase III clinical trials for NONS followed by its commercial launch inIndia by the fourth quarter of 2021.
In North America Glenmark has over 171 products authorized fordistribution in the US and another 41 products pending authorization. We are working tofile 18-20 ANDAs in FY22 including 5-6 filings that got delayed in FY21 because of thepandemic. The Monroe facility will play a critical role in this endeavor.