Key Performance Highlights
- Consolidated Revenue for Q3FY17 was Rs 25,350 million, an increase of 42.55% over last year, Excluding other revenue it is Rs 24,812 million, an increase of 39.53%
- Revenue for 9 months was Rs 67,284 million, an increase of 25.93%
- Forex Gain of Rs 5 crores and interest income of Rs 49 crores
- EBITDA margins are trending between 20-21%
- Fixed asset addition of Rs 220 crores this Q3. Intangibles acquisition was around 35-40 crores
- Tax rate for the Quarter is 28%
- Net working capital in terms of days was 105-110 days
- Company has Cash of $250 million
- Capex of Rs 600 crores
- The company has given a guidance of 15-20% CAGR for 3 to 5 years
- Gross Debt as on 31st December for the company is Rs 5,495 crore. Net debt is Rs 3,750 crores
- Increase in net debt for 9 months was 550 crores
- Interest cost of 62 crores
- Sales from formulations business for Q3FY17 was Rs 5,168 million with a growth of 5.91%
- Increase in Market share by 0.1%, with increase in value growth of 15% as compared to 10% last year
- Glenmark has 8 brands among top 300 brands of the Indian pharmaceutical company
- The India business strengthened itself in the following therapeutic segments with growth in market share from December 2016 to December 2015
- Revenue from sale of finished dosage was Rs 12,308 million with an increase of 102.15%
- Announced availability of Ezetimibe only generic version of ZETIA in US for treatment of high cholesterol on Dec 12 2016. Glenmark and its partner, Endo will be entitled to 180 days Management Discussion & Analysis: Q3 FY 2016 – 17 2 of 8 of generic drug exclusivity for Ezetimibe
- Granted approval for launch of Nystatin & Triamcinolone Cream. The company launched Triamcinolone Acetonide Cream USP, 0.1% and Potassium Chloride Extended-Release Tablets USP, 10 mEq & 20 mEq
- Glenmark’s marketing portfolio through December 31, 2016 consists of 112 generic products authorized for distribution in the U.S. market. The Company currently has 63 applications pending in various stages of the approval process with the US FDA, of which 24 are Paragraph IV applications.
- Revenue from Europe was at $ 1,957 million, with an increase of 10.98%. Europe’s business grew at 15% on a constant currency aided by good growth in the Western Europe region
- The Central Eastern Europe region continued to remain subdued impacting the overall growth for the region
- During the quarter, four products were launched in the UK, four product were launched in Germany and two products launched in Spain
- The company has filed respiratory programs for EU in 13-15 countries
- Revenue from Latin America was at Rs 947.20 million recording a decrease of 23.44%
- The Latam region continued to remain subdued on account of the base effect from sales arising from Venezuela.
- The overall growth for the Brazilian subsidiary in the third quarter continues to be impacted due to the weak economic environment and due to lack of new product approvals.
- The Mexico subsidiary recorded double digit growth in constant currency for the quarter.
Asia Africa and CIC region (ROW)
- Revenue from Asia,Africa & CIS region was Rs 2,511 million recording an increase of 6.25%.
- The Russian subsidiary recorded sales growth of 34%.
- Glenmark's Russia dermatology business grew 65.1% versus overall dermatology market growth of 9.9%.
- The subsidiaries of Malaysia, Vietnam and South Africa recorded good secondary sales growth for the third quarter.
- During the quarter Glenmark launched 2 products in the Asia region and 5 products in the Africa region.
- Revenue from sales of API was $ 1,920 million recording a increase of 32.47%
- The good growth of the business was due to the successful launch of Olmesartan with Mylan under 180 days market exclusivity
- The good growth was contributed by sale of Perindopril, Adapalene, Amiodarone.
- Glenmark filed for 2 US DMF’s in Q3 FY17
BEAT® (Bispecific Engagement by Antibodies based on the T cell receptor) is Glenmark's proprietary technology for the production of bi-specific antibodies (bsAbs). Engaging two targets with one bispecific antibody is an approach to target cancer cells, for instance by the redirection of cytolitic T cells. With the BEAT® technology, Glenmark's scientists have been able to overcome past production obstacles encountered with bsAbs and efficiently manufacture these molecules on an industrial scale.
Research And Development
- R&D in the Q3 was Rs 276 crores which was 11.12% of sales. For 9 months the R&D was Rs 706 crores which is 10.70% of sales
- Out of R&D of 11% of sales, 60% is generics & 40% is innovation specialty
- The company has a pipeline of 7 NMEs, which includes 2 new chemical entities and five new biological entities in various stages of clinical development, focused in therapeutic areas of oncology, respiratory and dermatology.
- Filed 5 ANDA application with the USFDA & plans to file another 10 applications in the coming quarter. The total number of ANDA during the year is 11
- For full year the ANDA expected to be filed is 20-22
GBR 1302 : A HER2xCD3 bispecific antibody, is the first clinical candidate based on Glenmark’s proprietary best-in-class BEAT® platform. Preclinical study results from redirected lysis assays suggest GBR 1302 has superiority to current 1st and 2nd line HER2-targeted monoclonal antibodies through faster and more complete killing of HER2+ tumor cells. If confirmed in clinical trials, GBR 1302 will constitute an innovative treatment for HER2 positive cancers, and potentially prove superior to the currently available monoclonal antibody treatments. Glenmark has initiated a Phase 1 trial for GBR 1302 in Germany and will soon expand recruitment to the USA.
GBR 1342: A CD38xCD3 bispecific antibody based on Glenmark’s proprietary BEAT® platform. It targets CD38, a proven target in multiple myeloma. Results from preclinical assays in comparison to daratumumab, an FDA-approved monoclonal antibody targeting CD38, suggest that GBR 1342 has a more potent antitumor effect on patient derived multiple myeloma cell lines. GBR 1342 is also being developed for the treatment of other malignancies of hematopoietic origin. Glenmark plans to file an Investigational New Drug (IND) application to initiate a Phase 1 study in the second half of CY 2017.
New treatments have improved the survival rate in multiple myeloma patients, but the disease remains incurable. Given the age of the patient population there are also substantial challenges in managing the toxicity of available therapies.
GBR 8383: A new type of highly potent OX40R agonist and it potentially represents the first in a new class of potent Immuno-Oncology molecules. OX40R is a member of the TNFR superfamily and is expressed on activated CD4 and CD8 T cells as well as a number of other lymphoid and non-lymphoid cells. Preclinical data has confirmed a strong agonistic effect on the ImmunoOncology targetOX40R in comparison to other OX40 agonists currently in the clinic.
GBR 1372: An EGFRxCD3 bispecific antibody based on Glenmark’s proprietary BEAT® platform. It targets epidermal growth factor receptor, a proven target in several cancers including squamous cell carcinoma of the head and neck and colorectal cancer. In vivo preclinically GBR 1372 has demonstrated preclinically the ability to bypass KRAS and BRAF mutation limitations of current therapies such as Erbitux/Vectibix. It is currently being developed for the treatment of colorectal cancer refractory to Erbitux/Vectibix. GBR 1372 is currently in pre-clinical studies and is also being developed for non-small cell lung cancer (NSCLC) and Head & Neck cancers.
Based on the most recent data, colorectal cancer is the fourth leading cause of cancer death worldwide. Currently, the most reliable way to predict whether a colorectal cancer patient will respond to EGFR-inhibiting drugs is to test for certain mutations in the gene that encodes KRAS, which occurs in 35%-45% of colorectal cancers
GBR 830: An anti-OX40R monoclonal antibody, was discovered at the Glenmark Biologics Research Centre located in Switzerland. It is a OX40R antagonist targeting activated T cells and effector memory T cells. In a Phase 1 study GBR 830 was safe and well-tolerated with no significant safety issues. GBR 830 is currently in an ongoing Phase 2 proof of concept study in the U.S.A. and Canada in adults suffering from moderate-to-severe atopic dermatitis. Development of GBR 830 for the treatment of other autoimmune disorders is also underway.
Atopic dermatitis is the most common inflammatory skin disease, affecting up to 3% of the adult population and its prevalence has increased 2-3 fold over the last 100 years. Biologic agents in moderate to severe atopic dermatitis offer promise to both control the disease and prevent the occurrence of new skin lesions.
GRC 388XX: An NCE currently in pre-clinical studies. Targeted indications for GBR 388XX included chronic obstructive pulmonary disorder (COPD) and idiopathic pulmonary fibrosis (IPF). Its class and mechanism of action are currently undisclosed.
GSP 301: A specialty combination of a steroid and an anti-histamine administered intranasally for the treatment of seasonal allergic rhinitis in adults and children. Glenmark has two ongoing Phase 3 trials to support its regulatory review. Despite advances in therapy there is increasing prevalence of allergic rhinitis in countries with a Western lifestyle. Although topical nasal corticosteroids and non-sedating antihistamines are highly effective in treating allergic rhinitis, there remains a group of patients who have a poor response to these treatments.
GSP 304: A long-acting muscarinic antagonist for administration by nebulization for the long term, once-daily, maintenance treatment of bronchospasm associated with COPD. Glenmark plans to initiate a Phase 2 study in the next six months for patients with mild to moderate COPD as established by the Global Initiative for Chronic Obstructive Lung Disease. COPD is a preventable, but incurable disease and based on the most recent data is the third leading cause of death worldwide.
GBR 310: A biosimilar candidate currently in preclinical studies being developed for the treatment of asthma and chronic idiopathic urticaria. GBR 310 has the potential to be among the first respiratory biosimilars approved in the USA. Asthma affects an estimated 300 million people worldwide and the morbidity and economic burden is significant, with approximately 240,000 asthma-related deaths per year.
GRC 27864 : A candidate for out-licensing. It is a potent, selective, and orally bioavailable inhibitor of microsomal prostaglandin E synthase-1 (mPGES-1), a novel therapeutic target in pain management, which is up-regulated under inflammatory conditions. A Phase I first-in-human single ascending dose and a multiple ascending dose study has been completed in the UK with no safety concerns. It is currently in Phase 2 development.
The rest of the assets such as GRC 17536, GBR 900, GBR 500 continue to progress. These 3 molecules and GRC 27864 are candidates for out-licensing.