29 Jul 2008
, Gurgaon, India
: The Board of Directors of Ranbaxy Laboratories Limited (RLL) at their meeting held today, took on record the unaudited results for the quarter ended June 30, 2008.
Key Highlights for the quarter (Q2 , 2008)*:
- Consolidated sales at USD 440 Mn, (Rs 18,296 Mn), records growth of 11%.
- Operating Profit after Tax at USD 39 Mn (Rs 1,608 Mn).
- Earnings before Interest, Depreciation, Tax & Amortization (EBIDTA) reflects margin to sales of 16.8% ( 2007: 16.4%) .
Key Highlights for the first half ( H1, 2008)* :
- Consolidated sales at USD 849 Mn (Rs 34,527 Mn), records growth of 13%.
- Operating Profit after Tax at USD 69 Mn (Rs 2,804 Mn), +6%.
- Earnings before Interest, Depreciation, Tax & Amortization (EBIDTA) reflects margin to sales of 15.9% ( 2007 : 15.0 %) .
Consolidated Financial Performance* Figures in USD Mn
|
Particulars |
Q2 ’08 |
Q2 ’07 |
% Ch. |
H1 ’08 |
H1 ’07 |
% Ch. |
| Sales |
440 |
395 |
+11 |
849 |
750 |
+13 |
|
Earnings before Interest, Depreciation, Tax & Amortization (EBIDTA) |
74 |
65 |
+14 |
135 |
113 |
+20 |
|
EBIDTA margins (% to Sales) |
16.8% |
16.4% |
- |
15.9% |
15.0% |
- |
|
Profit After Tax (PAT) |
39 |
39 |
- |
69 |
63 |
+10 |
Figures in Rs Mn
|
Particulars |
Q2 ’08 |
Q2 ’07 |
% Ch. |
H1 ’08 |
H1 ’07 |
% Ch. |
| Sales |
18,296 |
16,238 |
+13 |
34,527 |
31,882 |
+8 |
|
Earnings before Interest, Depreciation, Tax & Amortization (EBIDTA) |
3,080 |
2,664 |
+16 |
5,505 |
4,791 |
+15 |
|
Profit After Tax (PAT) |
1,608 |
1,604 |
- |
2,804 |
2,650 |
+6 |
* Excludes foreign exchange gains/losses on translation & extra-ordinary items
Commenting on the long ranging positive developments in the quarter, Mr. Malvinder Mohan Singh, CEO and MD, Ranbaxy, said, "Most striking has been our path-breaking deal with Daiichi Sankyo which I believe will substantially alter the rules of the game and re-define the global pharmaceutical landscape. We have the early mover advantage and are best placed to gain from the complementary strengths of both partners in capitalizing on the opportunities available across the entire pharmaceutical value spectrum. We expect performance to be stronger as we move through the rest of the year.”
Global Region wise Sales Figures in USD Mn
|
Region / Country |
Q2 ’08 |
Q2 ’07 |
% Ch. |
H1 ’08 |
H1 ’07 |
% Ch. |
|
North America |
120 |
102 |
+18 |
230 |
193 |
+19 |
|
India |
90 |
87 |
+3 |
175 |
160 |
+10 |
|
Europe |
89 |
86 |
+4 |
172 |
179 |
(4) |
|
Asia Pacific & CIS(Excl. India) |
49 |
41 |
+20 |
98 |
78 |
+26 |
|
Rest of World |
60 |
54 |
+11 |
112 |
92 |
+21 |
|
Active Pharmaceutical Ingredients (API) |
32 |
25 |
+31 |
62 |
48 |
+29 |
|
Global Sales |
440 |
395 |
+11 |
849 |
750 |
+13 |
- Developed markets accounted for 40% to global sales and recorded a growth of 12%. USA, Canada & France were the primary contributors to growth. Emerging markets contributed 53% of global sales and grew 9%. Key countries in Latin America, Asia Pacific and Africa contributed to the growth in emerging markets.
- North America sales at USD 120 Mn, +18%. Sotret, the Company’s leading brand in the dermatology segment, consolidates market leadership position with 53% market share.
- Company announced that its promoters, the Singh family and the Company, have entered into a binding Share Purchase and Share Subscription Agreement with Daiichi Sankyo, the second largest innovator pharmaceutical Company in Japan. Both the Companies believe that this transaction will create significant long-term value for all stakeholders.
- Company enters into an agreement with Pfizer Inc. to settle most of the patent litigation worldwide, involving Atorvastatin (Lipitor), the world’s most-prescribed cholesterol-lowering medicine. Lipitor is the world's largest selling drug with worldwide sales of USD12.7 Bn in 2007.
- Ranbaxy receives tentative approval from the U.S. Food and Drug Administration to manufacture and market Valganciclovir Hydrochloride Tablets, 450 mg. The Company believes that it has First-to-File status on the product with total annual market sales at USD 239 Mn (IMS – MAT: March 2008).
- Company signs a strategic Product Development Agreement with Merck & Co. Inc. in the therapeutic area of anti-infectives. The deal involves an undisclosed upfront sum payment, with the potential to receive payments totaling more than USD 100 Mn and significant royalties on worldwide net sales of any products commercialized under the Agreement.
- Ranbaxy enters into a strategic business alliance with Orchid Chemicals & Pharmaceuticals Limited, involving multiple geographies and therapies for both finished dosage formulations and active pharmaceutical ingredients. The alliance is expected to be mutually beneficial and synergistic, allowing both organisations to leverage each others strengths and capabilities.
Consolidated Results (Ranbaxy Laboratories Limited and Subsidiaries)
Quarter ended June 30, 2008 (Q2)
For Q2, the Company achieved Sales of Rs. 18,296 Mn [USD 440 Mn] (2007: Rs. 16,238 Mn, USD 395 Mn), recording a growth of 13%. Profit before finance cost, depreciation, tax and amortization was Rs. 3,261 Mn [USD 78 Mn] (Rs. 2,265 Mn, USD 55 Mn), reflecting an EBITDA margin of 17.8% to sales. Excluding the foreign exchange gains/losses on translation, EBITDA margins stood at 16.8% to sales. Profit after tax excluding the foreign exchange gains / losses on translation was at Rs 1,608 Mn [USD 39 Mn], similar to the corresponding previous quarter. Reported Profit after tax was at Rs. 229 Mn [USD 6 Mn].
Earnings per share on a fully diluted basis were Rs. 0.61 (2007: Rs. 4.23).
Half year ended June 30, 2008 (H1)
For H1, the Company recorded Sales of Rs. 34,527 Mn [USD 849 Mn] (2007: Rs. 31,882 Mn, USD 750 Mn), registering a growth of 8%. Profit before finance cost, depreciation, tax and amortization was Rs. 5,813 Mn [USD 143 Mn] (Rs. 4,173 Mn, USD 98 Mn), reflecting an EBITDA margin of 16.8% to sales. Excluding the foreign exchange gains/losses on translation, EBITDA margins were at 15.9% to sales. Profit after tax, excluding the foreign exchange gains / losses on translation, was at Rs 2,804 Mn [USD 69 Mn] (Rs 2,650 Mn, USD 63 Mn), recording a growth of 6%. Reported Profit after tax was at Rs. 1,597 Mn [USD 39 Mn].
Earnings per share on a fully diluted basis were Rs. 4.27 (2007: Rs. 6.75).
Global Sales
For Q2, Consolidated Sales were at USD 440 Mn, an increase of 11%. Developed markets led by USA and Canada, contributed 40% to global sales and grew 12% whereas the Emerging markets accounted for 53% to global sales and recorded a growth of 9%. The Active Pharmaceutical Ingredients (API) business recorded a growth of 31% and contributed 7% to sales. International dosage forms at USD 318 Mn for Q2’08, grew by 12% over the corresponding previous period and was 72 % of Global Sales.
For H1, Global Sales at USD 849 Mn, recorded a growth of 13%. Developed markets recorded a growth of 14% while the Emerging markets grew 10%, both contributing similarly to global sales as in the quarter. The API business recorded a growth of 31%.
North America
North America, comprising USA and Canada, recorded sales of USD 120 Mn, +18%, in the quarter. For H1, sales were at USD 230 Mn, +19%.
USA recorded sales of USD 106 Mn for the Quarter, a growth of 12% over the corresponding previous period. Volume growth, contribution from new products introduced during the year and a robust performance from the branded business led to an overall improved performance. For H1, USA recorded a growth of 14% with sales at USD 206 Mn
The overall market share of Ranbaxy in the US generic market (in the molecules Ranbaxy is present) was ~10.3% for Q2 ’08. .
The branded business continued to register a robust growth momentum, with Sotret maintaining its lead market standing and a strong performance coming from the dermatology products basket that was successfully re-launched post acquisition from Bristol Myers Squibb last year. With the expansion of the sales force, the targeted doctor coverage for Sotret has increased to 85%. Sotret currently has a market share of 53.3% with the 30mg dosage strength of the product holding its leadership position with a 68% market share.
A significant highlight during the quarter, was the agreement with Pfizer Inc. to settle most of the patent litigation worldwide, involving Atorvastatin (Lipitor), the world’s most-prescribed cholesterol-lowering medicine. Lipitor is the world's largest selling drug with worldwide sales in 2007, of USD 12.7 Bn. The key highlights of the deal are:
- The Company will have a license to sell generic versions of Atorvastatin (Lipitor) and the fixed-dose combination of Atorvastatin-Amlodipine besylate (Caduet) in the United States, effective Nov. 30, 2011.
- The Company will also have a license to sell Atorvastatin on varying dates in an additional 7 countries, including: Canada, Belgium, Netherlands, Germany, Sweden, Italy and Australia. Disputes between the Company & Pfizer regarding Atorvastatin in Malaysia, Brunei, Peru and Vietnam have also been settled.
- The settlement also resolves additional patent litigation between the companies involving the branded drugs Accupril .i.e. Quinapril Hydrochloride (in the U.S.) and Viagra .i.e. Sildenafil (in Ecuador).
Canada
The business in Canada continued its strong growth momentum doubling sales to USD 14 Mn over the corresponding previous period. For H1, sales in Canada were at USD 24 Mn, a robust growth of 91%. While key products such as Citalporam and Ciprofloxacin continued to perform well, Rabiprazole and Pantaprazole, both ultra generic products launched in Q1 & Q2 of 2008 respectively, also contributed significantly to sales.
Europe
In Q2 2008, Europe (including Romania) recorded sales of USD 89 Mn, 4% better than the corresponding previous period, while for the first half, sales in Europe stood at USD 172 Mn, a marginal decline of 4%. Romania recorded sales of USD 31 Mn for the Quarter, a growth of 5% over the corresponding previous period, while in H1, sales were at USD 57 Mn, a decline of 14%. Sales in Romania were impacted as a result of the ongoing healthcare reforms in the market place However, sales in the current quarter grew 17% versus the trailing quarter i.e. Q1 2008, signaling the gradual improvement in operations and the positive impact of branded prescribing which was introduced from April 1, 2008. France, the second largest market for the Company in EU, recorded a growth of 11% to USD 18 Mn. Two new day-one products were launched in the Quarter i.e. Loratidine & Clarithromycin. For H1, sales in France recorded a growth of 4% to USD 30 Mn. UK & Germany recorded sales of USD 10 Mn and USD 8.5 Mn respectively, a decline of 22% and 30%. While UK continued to witness difficult market conditions, sales in Germany were impacted due to the high base of sales in the corresponding previous quarter, as a result of the business accruing from the previous AOK contracts. For H1, sales in UK & Germany were at USD 21 Mn and 19 Mn respectively.
Sales in Rest of Europe were at USD 22 Mn, a growth of 40% over the corresponding previous period. For H1,sales stood at USD 46 Mn, a growth of 21%. Italy and Spain, the recently entered newer markets, recorded combined sales of USD 6 Mn in the quarter, a growth of 10%, while Poland and Central Europe recorded sales of approx. USD 5 Mn each, +31% and +53% respectively. Ranbaxy is the fastest growing Company in the generic segment in Italy and is currently ranked 8th.
Asia Pacific & CIS
The region recorded sales of USD 136 Mn for the Quarter, 8% better than previous year. Most countries recorded a good growth in the region led by CIS, Middle East, China, Japan and Thailand. For H1, sales in the region stood at USD 267 Mn, +15%.
India
The sales for the Quarter were at USD 79 Mn, at similar levels to those of the corresponding previous period. During the Quarter, the Company launched 26 new products across several therapies like antibiotics, cardiovascular, asthma, orthopedics and gastrointestinal. For H1 2008, sales recorded a growth of 7% to USD 154 Mn.
- During the Moving quarter (Mar - May 08), the Company garnered a market share of 5.28% (5.05% on MAT basis) and recorded a growth of 16.6% (Month- May 08) as compared to the industry growth of 7.8%. On a cumulative basis i.e. Jan- May 2008, the Company grew faster than the market at 20.3% ( versus 13.3% for the market)
- The Company has been ranked as the Number 1 consecutively for the last 3 months, i.e. April, May and June 08.
- Contribution of Chronic therapy portfolio for the Company stands at 24.7% to sales (May, 2008 Moving Quarter) against 24.2% over corresponding period last year. Ranbaxy's Chronic Portfolio has grown at a pace of 21.1%, marginally ahead than the 20.3% growth for the market.
- The Company has 17 brands in the top 300 brands of the industry. It has 9 Brands in the Top 100 list (Cum Jan – May 08)
CIS (Russia and Ukraine Belt)
The region recorded sales of USD 25 Mn for the Quarter, representing a growth of 44%. Sales in Russia grew by 49% to USD 15 Mn, while sales in the Ukraine region registered a growth of 37% to USD 10 Mn. For H1 2008, sales in the CIS countries grew by 36% to USD 49 Mn, with Russia at USD 28 Mn (+45%) and Ukraine at USD 21 Mn (+26%). Both the ethical and OTC segments in Russia continue to perform well and key products such as Cifran and Simvor maintained their leading market standings. With the investments made previously in the expansion and strengthening of the sales & marketing team, coupled with new product introductions, the CIS operations for the Company continue to register robust growth.
Asia Pacific (excl. India): Recorded sales of USD 24 Mn, a growth of 3%, while for H1, sales were at USD 49 Mn, +18%. Most countries in the region have shown buoyant growth led by Japan, China and Thailand. The Company’s business in Japan recorded sales of USD 6 Mn, +88% for the quarter (H1 sales at USD 10 Mn, +70%). The robust growth in Japan is a result of the pro-generic reforms introduced by the government effective Q1 2008. The Company also launched Amlodopine in the market during the quarter.
Middle East recorded sales of USD 6 Mn, 39% better than the corresponding previous period and for H1 sales were at USD 12 Mn, +34%.
Rest of the World (RoW)
Brazil: Sales were at USD 15 Mn for the Quarter, recording a growth of 45%. For H1, sales were at USD 25 Mn, +56%. The generic market in Brazil continues to exhibit buoyant growth, faster than the overall pharmaceutical market. The Company is currently ranked 6th in the generic market and has a 4% market share for the period MAT May 08 (2.9% in the corresponding prior period).
Africa: Recorded sales of USD 31 Mn, at similar levels to the corresponding previous period, while sales in the first half (H1) grew 12% to USD 62 Mn. Nigeria recorded a sales growth of 47% to USD 7 Mn in the quarter, while countries in East Africa also recorded good growth contributing to the performance. South Africa registered sales of USD 13 Mn, a de-growth of 5%. The Company’s core business sales in Africa (excluding the ARV business) achieved a growth of 17% for the quarter with sales at USD 45 Mn.
Global Consumer Healthcare (GCHC): Sales for the Quarter were USD 12 Mn, a growth of 36%, while for H1, sales recorded a growth of 32% to USD 21 Mn. Revital, the Company’s key brand further increased its market share by 5.5% to 83.9% (ORG SSA MAT May 08). The brand is currently ranked No 21 (MAT 08) versus No 31 during the corresponding previous period. The Company’s other brand, Chericof has recorded a good growth of 22.4% during the period MAT May 08 (ORG SSA).
Research & Development
During the Quarter, Ranbaxy entered into a strategic Product Development Agreement with Merck & Co., Inc. in the therapeutic area of anti-infectives. Both Ranbaxy and Merck & Co Inc., will work together to develop clinically validated anti-bacterial and anti-fungal drug candidates. The transaction involves undisclosed upfront sum payment, with the potential to receive payments totaling more than USD100 million associated with the achievement of various research, development and regulatory approval milestones for each target included in the collaboration. The Company is also eligible to receive significant royalties on worldwide net sales of any products commercialized under the Agreement.
During the Quarter, the Company filed 2 ANDAs including 1 PEPFAR filing with the US FDA and received approval for 4 regular ANDAs. This takes the cumulative filings to date to 239 ANDAs with 146 approvals. During the Quarter, in the European Union (EU), the Company made 3 national filings in 2 Reference Member States (RMS) and received 10 approvals in 5 RMS.
With respect to the anti-malaria molecule, RBx 11160 Phase II studies with the combination product have been completed in Thailand and India. Data management activities are currently ongoing. Regulatory submission for the pediatric efficacy / PK trial has been made in Africa and work is underway for regulatory submission to the Drug Controller General of India (DCGI) for inclusion of Indian sites. Reproductive toxicity studies are underway and are scheduled to be completed in various phases by end of 2008 / Q1 2009. Activities are in full swing to initiate Phase III trial in early 2009.
Currently there are three "in-house" compounds in the pre-clinical" development stage. One compound is a novel antibiotic belonging to the Ketolide class and other two molecules are being developed for COPD and Asthma. For all of these compounds, exploratory toxicity studies have been completed and pre-clinical regulatory studies are in progress. The compounds exhibit favorable pharmacokinetics and efficacy in animals and appear to be safe and superior when compared to the benchmarked marketed drugs.
The two collaborative programs with GSK under the alliance with them are well on track.
Ranbaxy Laboratories Limited, India's largest pharmaceutical company, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy’s continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company’s foray into Novel Drug Delivery Systems has led to proprietary "platform technologies," resulting in a number of products under development. The Company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 11 countries.