Glenmark to focus on dermatology medication

Mumbai-based Glenmark Pharmaceuticals Ltd will focus on developing medications for ailments relating to cardiology, dermatology and respiratory conditions.

Speaking on the sidelines of the launch of Diabetes treatment drugs using Teneligliptin-based drugs Ziten and Zita Plus, Sujesh Vasudevan, President and Head – India Business, Glenmark Pharmaceuticals, said dermatology is one of the fastest-growing areas as more people are giving importance to beauty and wellness.

“Though the products are sold based on prescription, people are increasingly opting for dermatology and cosmetology clinics because of the trust factor in the doctors rather than over-the-counter beauty products,” Vasudevan said.

The company will also be launching Teneligliptin and Metformin combination product, which is currently under clinical trials at 30 centres.

Glenmark expecting USFDA nod for 4-6 products this fiscal

Glenmark Pharmaceuticals is expecting approvals for four to six new products during the fiscal from the US Food and Drug Administration (USFDA), a senior official said on Monday. 

We are expecting approvals for 4-6 products from the USFDA during this year," Glenmark Pharmaceuticals President and Head-India Business Sujesh Vasudevan told reporters here on the sidelines of launch of Teneligliptin in Telangana. The company had already got approvals for eight products this year, he added. Teneligliptin, a new third generation oral anti-diabetic agent, is used for the management of Type 2 Diabetes Mellitus. Glenmark has launched this molecule under two brands, Ziten and Zita Plus, at Rs 19.90 per tablet. "The launch of these two products will lower the daily cost of treatment for a diabetes patient on Gliptin therapy by approximately 55 percent," Vasudevan said. Glenmark's diabetes segment is valued at around Rs 100 crore, Vasudevan said, adding it is growing at 20 percent per annum. Reacting to a query, he said, "The capex for this year is Rs 600 crore and majority of this will go for the plant in the US."

Glenmark to launch 10-12 new products in India, eyes 18-20 per cent growth

Mumbai headquartered drug firm Glenmark Pharmaceuticals proposes to launch 10-12 new products in the domestic market during the current financial year (2015-16) and hopes to report a growth of 18-20 per cent, said a top official. 

The Rs 6,600 crore firm in revenues last fiscal, earns over a fourth of revenues from the domestic market, mostly focusing on dermatology and diabetes drugs. The company may also look at acquiring brands or companies aimed at strengthening its market share in t .. 

We are going to launch 10-12 new products in India this year. We have already launched 4 products so far. New product launches would help us maintaining the high growth rate at around 18-20 per cent when the industry is growing at about 12 per cent", said Vasudevan while addressing journalists in Hyderabad on Monday on the eve of launching new oral drug Teneligliptin for type-2 diabetes. 

Glenmark, which currently earns around Rs 100 crore from the diabetes segment with a year on year growth of around 20 per cent, is planning to grow significantly with the help of new product launches going forward. 

"Our new combination drug of tenegliptin and metformin is under clinical trials now. We will launch this product once we get the approvals from the authorities", said Sujesh. 

He said the domestic diabetes drugs market is currently estimated at around Rs 6,600 crore and gliptins account for around Rs 1,200 crore. 

Glenmark receives USFDA nod for oral contraceptive drug

Glenmark Pharmaceuticals today said it has received final approval from the US health regulator to sell oral contraceptive -- drospirenone and ethinyl estradiol tablets -- in the US market.

"Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Drospirenone and Ethinyl Estradiol tablets USP, 3 mg/0.02 mg," the company said in a BSE filing.

The product is generic version Bayer's Yaz tablets.

Glenmark said it plans to commence shipping of drospirenone and ethinyl Estradiol tablets immediately.

Citing IMS Health sales data, the company said for the 12 months period ending June, "The Yaz market achieved annual sales of approximately $170.1 million".

Glenmark's shares were trading at Rs 1,213.65 apiece, up 4.62% from their previous close on BSE.

Glenmark: Revenue growth in recovery mode

Glenmark Pharma’s revenue growth estimate of 18-20 per cent, with a 200-basis point margin expansion (excluding licensing income) for FY16 seems to have been received well by the Street. After opening below its Monday closing price (a reaction to disappointment over the company’s earnings), the stock gained ground on Tuesday, closing at Rs 861.

For the company, growth in revenue is expected to be driven by its US operations, likely to grow about 20 per cent. Growth of only 7.1 per cent in the US market in the March quarter, as well as one-offs and cross-currency headwinds, had led to lower than expected numbers.

Analysts at HSBC believe the FY16 estimate is realistic; they maintain a ‘buy’ rating on the stock, with a revised target price of Rs 925. Other brokerage firms such as Reliance Securities, Antique Stock Broking, IDFC Securities and Prabhudas Lilladher have higher target prices — up to Rs 1,186.

The company posted almost flat (0.63 per cent) growth in US sales, which contributed about 30 per cent to its overall sales in FY15. This was due to slower approvals for new launches, even as its existing portfolio faced more competition. With six drug approvals in the past three months and more approvals expected, growth in FY16 is expected to be higher. Recent launches will have a substantial impact only in the second quarter of FY16, says Hitesh Mahida of Antique Stock Broking. Glenmark is expected to announce launches in specialty segments, particularly dermatology, which could help further, says Mahida.

Glenmark filed 18 abbreviated new drug applications in FY15. Of the 95 product launches in the US, 70 are pending approvals (including 33 Para IV). Analysts at Reliance Securities foresee a smart recovery (26 per cent compounded annual growth over FY15-17) in the US, led by a pick-up in approvals and launches. The potential launches of dermatology product Azelaic acid (size $95 million), ortho ($450 million), cholesterol-lowering drug Welchol ($420 million) and Zetia ($1.7 billion) paint a healthy outlook in the US in the medium term, say analysts. The Company will launch Zetia and Azelaic acid on an exclusivity basis and analysts expect at least one of the two to be launched by December 2016. Besides, the company’s focus on complex injectables (six pending approvals), oral-contraceptives (13) and dermatology (eight) is a positive.

The company is growing well in Europe and Latin America (combined contribution about 24 per cent to revenue). In the March quarter, these growth figures stood at 26 per cent and 75 per cent, respectively. Rest-of-the-world sales (12-13 per cent of revenue), however, fell — 36 per cent in the March quarter and 18 per cent in FY15. Primarily, this was because Russia was hit by a weak currency and subdued business environment. Nevertheless, new products have been lined up for this market, too.

Analysts at IDFC Securities say with multiple data points expected from six ‘first in class’ clinical candidates through the next 18 months, Glenmark could generate significant licensing revenue. Successful progression of even one of these could put it in a higher growth orbit in the medium term. The company plans to utilise proceeds from the Temasek stake sale ($152 million) to reduce debt. The company’s net debt stands at $484 million.

Mahida expects further improvement on this front, with Zetia’s launch-on-exclusivity, which is expected to lead to cash flow of about $150 million.