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Lupin FY 2008-09 Consolidated Net Profits up 50.2% to Rs 5015 mn

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Leading transnational pharmaceutical major, Lupin Limited, reported an outstanding performance for the fourth quarter and financial year ended March 31st, 2009. These audited results were taken on record by the Board of Directors at a meeting held in Mumbai on 13th May, 2009.

Key Highlights – Consolidated FY 08-09

 Net sales grew at 39.5% to Rs. 37759 million from Rs. 27064 million last year

  • Net profits grew at 50.2%  to Rs. 5015 million compared to Rs 3338 mn in previous year (excluding IP income)
  • EBITDA margin increased to 19.7%
  • Exports up 63.2% at Rs. 24701 mn
  • Advanced markets sales (including Japan and ANZ) increased 92% over last year and contributed 50% of the Net Sales for the year as against 30% in the previous year.
  • Advanced Markets sales to US and EU grew 70% at Rs 14310  million including API
  • One of the fastest growing generic players in the US by prescriptions and the 9th largest in terms of total prescription base
  • A basket of 22 products in the US with 8 market leaders
  • Domestic Formulations Business grew at 24.6%% to Rs. 10,575 million.
  • Lupin’s Japanese subsidiary, Kyowa contributed 12% of the overall revenues – Rs. 4424 million
  • 28 ANDA’s, 15 DMF’s, 18 MAA’s,6 EDMF’s,3 COS, & 1 AU DMF were filed during FY 08-09.
  • Four Major Acquisitions across Germany, Australia, South Africa and the Philippines
  • Dividend Announcement of 125 %

Key Highlights Q4 FY 08-09

  • Net sales growth for Q4 FY 08-09 was 39% at Rs. 10434 million.
  • Advanced markets sales including Japan increased 60% at Rs 5196 million over Q4 FY 07-08
  • Net profit for Q4 FY 08-09 grew at 64.2% at  Rs. 1574 million compared to Rs 959 million in Q4 FY 07-08

 Commenting on Lupin’s performance, Dr. Kamal K Sharma, Managing Director, Lupin Limited, said,“Lupin’s stellar performance reflects the strong business philosophy guiding us. Lupin has had a very strong year driven by growth and consistent performance across all business segments and markets: a strong business performance in the US, solid domestic growth & increased activity in all key markets. Lupin’s acquisitions have not only consolidated our existing presence in these markets but also leaves us strategically poised to further strengthening our position in the global generics and branded generics market. It has indeed been a year of many achievements and robust growth, and  poised to not only address market needs but also maintain momentum and direction.”

 Financials:

 Advanced markets – US & Europe

 Lupin continued its growth momentum in the US and Europe with it contributing a healthy 36% to our total revenues at Rs. 13634 million. (Formulations)

USA:

 Lupin Pharmaceutical Inc, the company’s US subsidiary reported a stellar performance recording sales of Rs. 12563 million reflecting a growth of  74.4% as compared to Rs. 7205 million in FY 07-08. Lupin’s Generic and the Brand business recorded exponential growth during the financial year.

 More importantly, FY 08-09 saw Lupin increasing its product portfolio in the branded generics segment through the launch of AeroChamber. LPI forged a Strategic Alliance with Forest Laboratories, Inc. for marketing and promoting AeroChamber Plus® thereby extending Lupin’s presence in the respiratory segment and our franchise with Pediatricians which would also additionally open up new offices for Suprax. The brand business contributed 27% to the overall business at USD 74 mn

 The company further expanded and consolidated on its generic product portfolio with the launches of Ramipril caps, Divalproex DR tabs, Cefadroxil suspension and caps & Levetiracetam tabs. The Company now has a total of 22 products in the market, out of which 8 are market leaders. We are in the top 3 market positions  by market share in 17 of these products (IMS Jan 09).

 Lupin today is one of the fastest growing generic players in the US based on growth in prescriptions and the 9th largest in terms of total prescription base.

 LPI was also recognized by Wal-Mart and awarded its prestigious “Supplier Award of Excellence” for the 2nd Quarter 2008 – which is an acknowledgement of the inroads we have made into the US markets.

 During the year, the company demonstrated its capabilities on the Intellectual Property management front by successfully litigating and settling all ongoing Hatch-Waxman litigation relating to Desloratadine tablets, the generic version of Schering-Plough’s “Clarinex”® tablets. As per the terms of the settlement, Lupin Ltd. will be licensed under the relevant Desloratadine patents, and free to commercially launch its generic Desloratadine product, on July 1, 2012, or earlier in certain circumstances. Schering-Plough’s Clarinex® tablets had U.S. sales of $329 million for the year 2007-MAT June 2008, according to IMS Health.

 Lupin also received the final approval for the Company’s Abbreviated New Drug Application (ANDA) for Levetiracetam Tablets 250mg, 500mg, 750 mg and 1000 mg from the U.S. Food and Drug Administration (USFDA). Commercial shipments of the product have commenced.

 Lupin’s Levetiracetam tablets are the AB-rated generic equivalent of UCB Pharmaceuticals’ Keppra® tablets, indicated as adjunctive therapy in the treatment of certain types of seizures associated with epilepsy. Keppra tablets had annual sales of approximately $ 1.2 billion (USD) for the twelve months ended September 2008, based on IMS Health sales data.

Europe:

 Lupin further strengthened its presence in the European Union by completeing its acquisition of Hormosan Pharma GmbH (Hormosan), a German generics company specialized in the supply of pharmaceutical products for the Central Nervous System (CNS).

 We also recorded our first strategic win in the German market through Hormosan in the next two quarters – having received information on the results of the Allgemeine Ortskrankenkassen (AOK) Tender, pursuant to § 130a SGB V. Hormosan has been offered to supply Setraline in all 5 regions of Germany covering all AOK-insured persons. 

 Hormosan has a strong brand identity in the German generics market through its strong patient compliance message, essential for patients within the CNS sector.

 Lupin also made strategic inroads into the French market by launching Cefpodoxime Proxetil suspension in Q3. Cefpodoxime Proxetil has over 60 % market share in France.

  AAMLA

Japan:

Kyowa, the Company’s subsidiary in Japan posted robust net sales at Rs 4424 mn contributing 12% of Lupin’s Revenues having grown at over 21 % YoY

 Our products like Amlodipine “Amel” continues to maintain majority market share and Risperidone “Amel”, which was launched last year, continue to exhibit market leadership in unit terms.

South Africa

 Lupin clocked in revenues of Rs 919 million after having acquired a equity stake in Pharma Dynamics (PD) in South Africa in September 08. Pharma Dynamics is one of the fastest growing generic companies in South Africa growing at around 30 % for FY 08-09 with a clear leadership in the cardiovascular segment.

 PD is ranked number 6 amongst generic companies in South Africa. The South African Generics Market is currently valued at close to 800 Million USD and growing rapidly

 Phillipines

In March 2009 the Company acquired a majority stake in Multicare Pharmaceuticals Phillipines, Inc. (MC) in Phillipines. MC is a premium branded generics company with a strong position in women’s health and child care segment.

ANZ

 The Company continued its focus on this important market with aggressive filings in Australia, taking the cumulative MAA filings to 24 till date of which 18 have been approved.

 Emerging Markets

 India: Domestic Formulations forms a very important part of Lupin overall growth. In the current financial year, it contributed about 28% of the net sales at Rs 10,575 million as against Rs. 8,487 million registering a growth of 24.6% over the previous year.

 This growth was driven by the good performance in the CVS, Diabetes, CNS, Asthma and Gastro therapy Segments. The divisions catering to branded segments continued to outpace the industry growing over 27%. Lupin has maintained its leadership in Anti-TB segment and has secured a double digit market share in the anti-asthma market riding high on the strengths of its offerings in this segment.

 Research and Development

 Research & Develpment has always been a strategic and key focus area for Lupin and this year – 2008-09 was no exception with 6% of the sales earmarked for R&D and related spends.

 The year 2008-09 was a landmark year with Lupin filing 28 Abbreviated New Drug Application (ANDA) with the USFDA, 11 DMF’s, 15 MAA’s and two EDMF’s during the year.

 The cumulative ANDA filings were at 90 with 34 approvals granted by the USFDA.

 Lupin also received the final approval for the Company’s Abbreviated New Drug Application (ANDA) for Levetiracetam Tablets 250mg, 500mg, 750 mg and 1000 mg from the U.S. Food and Drug Administration (USFDA) during the quarter. 

Other

 The USFDA issued a warning letter for the Cephalosporin facility of the Mandideep plant.  The facility was inspected in November, 2008 for a routine GMP inspection.  As a result Lupin had received 15 procedural observations.  Lupin responded to the observations in December and provided corrective actions for each of the responses.  

The warning letter was issued to provide Lupin with an opportunity to submit additional documentation and explanation to a few selected observations where the  FDA felt that the initial responses were inadequate and could be strengthened by further evidence of compliance with enhanced documentation practices.

 All products maintain their approved status. Lupin manufacturing will not be disrupted and it will continue to provide quality products to customers without interruption. 

Lupin has formulated a strategy to address and resolve the USFDA and is confident of being able to satisfy the USFDA’s observations expeditiously.

Dividend

In view of excellent performance, the Board of Directors recommended a dividend of 125 % i.e Rs. 12.50 per equity share of the face value of Rs. 10 each.

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Written by sreelakshmi

22 May, 2009 at 7:08 am

Lupin Announces Litigation Settlement with Wyeth for Venlafaxine Extended Release Capsules

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 Pharma Major, Lupin Ltd. announced on 11th May, 2009 that it has settled all ongoing Hatch-Waxman litigation relating to Venlafaxine extended release capsules, Lupin’s generic version of Wyeth’s antidepressant “Effexor XR®” capsules.

 
 

As per the terms of the settlement, Lupin Ltd. will be licensed under the relevant patents and would be free to commercially launch its generic product on or after 1st of June, 2011, or earlier in certain limited circumstances, but in no event earlier than January 1, 2011.

 
 

Lupin had earlier filed a Paragraph IV certification to U.S. Patent Nos. 6,274,171, 6,403,120 and 6,419,958, contesting that these patents were either invalid or had not been infringed.- resulting in the subsequent litigation by Wyeth.

 
 

Wyeth’s “Effexor XR®” capsules had U.S. sales of $3.01 billion for the year 2008 (IMS) and accounted for 17 percent of the company’s net revenue last year.

 
 

Commenting on the settlement, Dr. Kamal Sharma, Managing Director, Lupin said – “The settlement with Wyeth is in line with our growth strategies and would help us further strengthen our product pipeline and build strong market positions in the U.S. It is a testament to our prowess in Research & Development and our Intellectual Property management competencies – not to mention our strong focus to deliver high value, high quality products.”

 

Written by sreelakshmi

22 May, 2009 at 12:33 am

Lupin Limited announces alliance with Natco Pharma

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Alliance to commercialize generic equivalent of FOSRENOL® Tablets

Lupin Ltd. and Natco announced today an alliance to jointly commercialize generic equivalents of Shire plc’s FOSRENOL® (lanthanum carbonate) tablets. Shire had filed a lawsuit against Natco for infringement of two patents for FOSRENOL® in response to an ANDA (Abbreviated New Drug Application) filing by Natco seeking US FDA approval to market and sell generic versions of Shire’s 500 mg, 750 mg, and 1 g of the FOSRENOL® tablets.

Natco and Lupin believe that they are amongst one of the first-to-files which would likely lead to 180 days exclusivity. FOSRENOL® had sales of USD 108 Million as of December – 2008 (IMS).

Commenting on the development, Mr. Nilesh Gupta, Group President and Executive Director to the Board, Lupin Limited said, “The alliance creates synergies that will enable portfolio expansion and contribute to consolidating our presence in the US markets. Lupin’s proven IP management capabilities, marketing reach and expertise coupled with Natco’s solid development and manufacturing abilities make for a great combination.”

Mr. Rajeev Nannapaneni, Chief Operating Officer, Natco Pharma
said, “Our alliance brings together a strong philosophy of working together to maximize opportunities in an increasingly competitive generic business. We are very happy to be associated with Lupin given their intellectual property management competencies and market strengths in the U.S.”


Written by sreelakshmi

10 April, 2009 at 6:37 am

Lupin ties up with leading Institutes for PhD Program

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Leading pharmaceuticals major, Lupin Limited, today announced a strategic tie-up with top academic echelons – Manipal University (Karnataka), Birla Institute of Technology and Sciences (Pilani) and Pune University – in a move to allow employees of Lupin’s R&D wing, Lupin Research Park, to pursue their industry specific research while concurrently working with Lupin. Through this industry – academia interface, Lupin employees can pursue industry specific research, making them eligible for a Doctorate degree to be awarded by these universities.

Launching the program, Nilesh Gupta, Group President and Executive Director to the Board, Lupin Limited, commented, “This is a win-win for both our people and the company and is a happy confluence of our scientific staff’s professional aspirations and the need to get an academic and research bent of mind built within our Research”. As a next step, the company plans to increase its reach to Top 10 institutes of Chemistry/Pharmacy in India.

Situated at Pune, the Lupin Research Park is spread across 19 acres and acts as the hub for Lupin’s global research and development programme. Its culture fosters innovation and helps shape inventions into innovative life saving drugs. Home to over 450 scientists who work in four broad areas of research and development – Generics Research, New Chemical Entities, Advance Drug Delivery Systems and Biotechnology – the facility creates new innovative life-saving drugs and technologies for a healthier tomorrow.

Written by sreelakshmi

9 March, 2009 at 8:52 pm

Lupin Q3 FY 08-09 – Strong Growth & Consistent Performance with Consolidated Sales up 32% to Rs. 9719 Mn and Net Profit – Rs 1165 Mn

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Pharma Major, Lupin Limited, yesterday reported revenues of Rs. 9719 mn for the quarter ended December 2008, a rise of 32 % from revenues of Rs. 7381 mn in the corresponding period last year.

International market revenues at Rs. 6505 mn, recorded a rise of 48%. Of these, Formulation Business in Advanced Markets constituted 77% at Rs. 4990 mn.

Earnings before Interest, Tax, Depreciation and Amortization (EBITDA) were Rs. 1761 mn (Rs. 1477 mn*) a rise of 19%. After Interest and Finance charges of Rs. 146 mn (Rs. 101 mn) and Depreciation of Rs. 219 mn (Rs.175 mn), Profit before Tax grew by 16% to Rs. 1396 mn (Rs. 1202 mn*). Provision for taxation including Fringe Benefit Tax was Rs. 219 mn (Rs. 201 mn*)

Net profit for the quarter was at Rs. 1165 mn. Increase in Net Profit for quarter over the corresponding quarter in the previous year (adjusted for IP income) works out to 16%.

For like representation IP income of Rs 1127 mn for the corresponding quarter of the previous year has been excluded to make the quarters comparable on an operational basis.

Commenting on the Company’s business results, Dr. Kamal Sharma, Managing Director, Lupin, said,”The past ten quarters have been noteworthy. We have continued to outpace and outperform across business segments and markets consistently having steadily consolidated our footprint globally. Recent launches, product approvals and patent settlements, substantial growth in filings, and more importantly – growth in market shares – are an affirmation of the success of our “Strategic Approach” & the effectiveness of our “Go to market” programs. Our strengths in Research & Development and the quality of our Intellectual property is a testimony to Lupin’s vision & commitment to developing and delivering quality & cost-effective drugs for everybody.”

Operational Summary

  • Growth in overall Sales in the U.S – Continued Market Leadership in 7 of the 20 products in the market.
  • Litigation Settlement with Schering-Plough Corporation for Desloratadine®
  • Hormosan AOK Tender win
  • Substantial Growth in Filings with two potential First to Files.
  • Domestic Formulations Business at Rs. 2791 mn – outpaces and outperforms the market with a growth of 27% on net sales basis. (Industry growth as per IMS MAT Nov 08 – 10.3%)

Advanced markets

The Company’s Advanced markets formulation business in USA and Europe clocked in sales of Rs 3405 mn during the Q3, 2008-09, ( Q3 2007-08: Rs 2297 mn) reporting a growth of 48%

USA

LPI has garnered a steady growth in prescriptions for generics as well as branded formulations during the quarter. The company achieved market leadership in 7 of the 20 products in the US markets (IMS Sept 08).

Lupin also settled all ongoing Hatch-Waxman litigation relating to Desloratadine tablets, the generic version of Schering-Plough’s “Clarinex”® tablets during the quarter. As per the terms of the settlement, Lupin Ltd. will be licensed under the relevant Desloratadine patents, and free to commercially launch its generic Desloratadine product, on July 1, 2012, or earlier in certain circumstances. Schering-Plough’s Clarinex® tablets had U.S. sales of $329 million for the year 2007-MAT June 2008, according to IMS Health.

Europe

Lupin further consolidated its market position in Europe by completing its acquisition of Hormosan Pharma GmbH (Hormosan), a German generics company specialized in the supply of pharmaceutical products for the Central Nervous System (CNS).

Lupin also reported its first strategic win in the German market through Hormosan in the very first three months post-acquisition – having received information on the results of the Allgemeine Ortskrankenkassen (AOK) Tender, pursuant to § 130a SGB V. Hormosan has been offered 1 products in all 5 regions of Germany covering all AOK-insured persons. The AOK tender process is currently under judicial review.

Hormosan has a strong brand identity in the German generics market through its strong patient compliance message, essential for patients within the CNS sector.

Emerging Markets:

The Formulations revenues from emerging markets including India reported a growth of 24% recording sales of Rs 3236 Mn during Q3, 2008-09 (Rs 2605 Mn, 2007-08)

API revenues from emerging markets (including India) were at Rs 1328 Mn. The Company’s CRAMS business through the new entity Novodigm is progressing well, reporting sales of Rs 125 mn for the third quarter. .

Domestic Market: India:

Company’s domestic formulations business in the third quarter registered gross Sales of Rs. 2791, registering a growth of 27% at the net sales level. For better representation, the sales arising from deemed exports of Rs. 104 mn (Rs.93 mn), and formerly recorded under domestic sales have not been classified along with the domestic formulations business. This growth was driven by the good performance in the CVS, Diabetes, CNS, Asthma and Gastro Segments. The divisions catering to branded segments continued to outpace the industry growing over 29%. Lupin has maintained its leadership in Anti-TB segment and has secured a double digit market share in the anti-asthma market riding high on the strengths of its offerings in this segment.

Other World Markets

The RoW Markets reported sales of Rs 445 Mn for the third quarter recording a growth of 40%.

Japan

Kyowa, the Company’s subsidiary in Japan posted robust sales at Rs 1319 mn registering a growth of 21% over the corresponding period of previous year. The recently launched Amlodipine “Amel” continues to maintain majority market share and Risperidone “Amel”, which was launched last year, continued market leadership in unit terms.

South Africa

Lupin also completed and consolidate its acquisition of a majority stake in Pharma Dynamics (PD) in South Africa. Pharma Dynamics is the fastest growing generic companies in South Africa (over 33% growth for Quarter 3 – 08-09) with a clear leadership in the cardiovascular segment.

PD ranks at number 6 amongst generic companies and is currently growing at 33% per annum as per IMS. The South African Generics Market is currently valued at close to 800 Million USD and growing rapidly.

Research & Development

Progress on Approvals & Filings

Lupin also filed Seven ANDAs filed in the quarter, taking the cumulative ANDA filings total to 76. The company has received 32 approvals to date including Levetiracetam, which has already been launched. Four (4) DMF filings have been made in the quarter, taking the total to 79. The company also filed four (4) MAAs with the European regulatory authorities.

Two (2) Potential first to files were filed in the quarter. Furthermore, litigation was initiated against Lupin on filing the generic versions of Fortamet ER (Metformin extended release tablets) and Antara (Fenofibrate tablets) during the quarter. The company believes that it is the first to file on both. The total tally of first to files stands at eight (8).

About Lupin Limited

Headquartered in Mumbai, India, Lupin Limited is an innovation led transnational pharmaceutical company producing a wide range of quality, affordable generic and branded formulations and APIs for the developed and developing markets of the world.

The Company has secured global leadership position in Anti-TB and Cephalosporins and has a significant presence in the areas of Cardiovasculars (prils and statins), Diabetology, Asthma and NSAIDs. The Company’s R&D endeavors have resulted in significant progress in its NCE program. The Company’s foray into Advanced Drug Delivery Systems has resulted in the development of platform technologies that are being used to develop value-added generic pharmaceuticals.

Currently positioned amongst the top six pharmaceutical companies of India, the Company is committed to achieve sustainable earnings and growth for all its stakeholders.

For the financial year ended March 2008, the Lupin’s Revenues and Profit after Tax were Rs.27,730 million (US$ 694 million) and Rs.4,083 million (US$ 102 million) respectively.

For further information please contact:

Lupin Limited:

Shamsher Gorawara

Head – Corporate Communications

Ph: 9820338555

Email: shamshergorawara@lupinpharma.com