Japanese firm Takeda's first-quarter results for fiscal year 2013 show sales up 3.0% year-on-year to JPY410.3 billion, as a USD554-million revenue hit due to Actos's loss of patent protection was absorbed by new products, emerging markets growth, and the yen's depreciation. Separately, Takeda has announced the receipt of approval from the China Food and Drug Administration to begin importing type 2 diabetes drug Nesina, a potentially significant milestone.
IHS Global Insight perspective | |
Significance | Takeda's first-quarter results for fiscal year 2013 show the firm shrugging off Actos's plummeting sales, with the weakening yen a significant factor in increasing overseas revenues and positive contributions from recent acquisitions. |
Implications | Takeda has quickly followed US and European approvals for Nesina, touted as Actos's successor, with approval in China, the world's largest type 2 diabetes market by patient population. |
Outlook | Takeda increased its sales forecast for the full year by JPY90 billion to reflect the effects of the weakening yen; the operating income forecast remained unchanged due to the negative effect of the yen in terms of increased sales expenses. |
Japanese firm Takeda has released results for the first quarter of fiscal year (FY) 2013/14, ending 30 June 2013. Net sales were up 3.0% year-on-year (y/y) to JPY410.3 billion (USD4.18 billion), as Takeda shrugged off a USD554-million loss following generic competition against Actos (pioglitazone) in the United States. This was achieved thanks to the contribution from 2012's acquisitions URL Pharma and Multilab, with a combined JPY11.2 billion increase, as well as steady growth in emerging markets, and a JPY40.0-billion boost to overseas sales due to the weakening yen. The weakening yen also had a negative impact on financials, contributing JPY32.9 billion to sales, general, and administrative (SG&A) expenses, and therefore affecting operating income, which fell by 23.8% y/y to JPY47.7 billion. Net income was down by 66.8% y/y to JPY29.1 billion, reflecting the comparison with the first quarter of FY 2012, which benefited from a JPY52.8-billion tax refund boost.
Takeda financial highlights, Q1 2013 | |||
FY 2012 | FY 2013 | % change (y/y) | |
Net sales | 398.3 | 410.3 | +3.0 |
- US and Canada | 104.9 | 91.1 | -13.2 |
- Europe* | 61.4 | 75.0 | +22.2 |
- Emerging markets | 48.8 | 65.7 | +34.6 |
- Japan | 145.5 | 140.2 | -3.7 |
- Consumer healthcare | 37.7 | 38.4 | +1.7 |
SG&A expenses | 153.5 | 170.0 | +10.7 |
R&D expenses | 78.9 | 77.5 | -1.7 |
Operating income | 62.6 | 47.7 | -23.8 |
Net income | 87.6 | 29.1 | -66.8 |
*Excluding Russia and CIS | |||
In terms of sales performance, 2012's acquisition of URL Pharma saw positive contributions from a number of new products, particularly gout treatment Colcrys (colchicine), while other products to see growing sales in the US were proton pump inhibitor Dexilant (dexlansoprazole) and multiple myeloma treatment Velcade (bortezomib). In Japan, hypertension drug Azilva (azilsartan), launched in 2012, saw growing sales, while in Europe lymphoma treatment Adcetris (brentuximab vedotin) was a strong performer. These helped counter Actos's rapidly plummeting sales.
Sales of major products, Q1 FY 2013 | ||||
Drug | Major sales region | Q1 FY 2012 sales (JPY, bil.) | Q1 FY 2013 sales (JPY, bil.) | % change |
Blopress (candesartan) | Worldwide | 47.5 | 42.4 | -10.8 |
Leuplin (leuprorelin) | Worldwide | 29.7 | 32.6 | +9.7 |
Takepron (lansoprazole) | Worldwide | 27.2 | 29.7 | +8.8 |
Actos (pioglitazone) | Worldwide | 55.8 | 10.5 | -81.1 |
Enbrel (etanercept) | Japan | 10.8 | 11.0 | +1.9 |
Nesina (alogliptin) | Japan | 7.1 | 7.3 | +2.5 |
Vectibix (panitumumab) | Japan | 4.8 | 4.8 | 0.0 |
Velcade (bortezomib) | US | 17.6 | 23.8 | +34.8 |
Colcrys (colchicine) * | US | 9.9 | 13.7 | +37.7 |
Dexilant (dexlansoprazole) | US | 7.0 | 11.1 | +57.9 |
Uloric (febuxostat) | US | 3.8 | 6.5 | +71.6 |
Amitiza (lubiprostone) | US | 5.0 | 6.1 | +21.5 |
Pantoprazole** | Europe/emerging markets | 20.2 | 22.9 | +13.6 |
Actovegin** | Europe/emerging markets | 3.9 | 7.4 | +89.5 |
Calcium** | Europe/emerging markets | 3.7 | 4.4 | +0.8 |
TachoSil** | Europe/emerging markets | 3.8 | 4.2 | +0.4 |
Daxas** | Europe/emerging markets | 0.7 | 1.0 | +0.3 |
Nycomed products in total | Europe/emerging markets | 754 (EUR mil.) | 813 (EUR mil.) | +7.8 |
*URL Pharma product | ||||
R&D highlights
In terms of R&D highlights, Takeda filed a biologics application in July for MLN0002 (vedolizumab) – a novel gut-selective monoclonal antibody – in the United States as a treatment for ulcerative colitis and Crohn's disease, following a March filing in Europe (see United States: 25 June 2013: Takeda files for US FDA approval of vedolizumab for Crohn's disease and ulcerative colitis).
Meanwhile, the firm is continuing to develop type 2 diabetes products, with TAK-875 (fasiglifam) at the Phase III stage in Europe, Japan, and the US, and projected to gain approval in Japan in 2015. The first-in-class GPR40 agonist reduces glucose with a low risk of hypoglycaemia (see Japan: 20 May 2013: Takeda releases positive Phase III results for diabetes drug fasiglifam). Meanwhile, Takeda announced results from a Phase III trial of Lu AA21004 (vortioxetine) in major depression, the latest pipeline product from the partnership with Lundbeck (Denmark; see Japan - Denmark: 20 May 2013: Lundbeck and Takeda announce Phase III clinical trial results for vortioxetine in depression).
Nesina approved in China
Separately, Takeda yesterday (31 July) announced the receipt of an import licence from the China Food and Drug Administration (CFDA) in relation to Nesina (alogliptin) as a type 2 diabetes treatment. The once-daily oral dipeptidyl peptidase-4 (DPP-4) inhibitor was approved on the back of a multi-centre Phase III trial held in Taiwan, Hong Kong, and mainland China. Approval in China follows belated approval from the US FDA in January (see United States - Japan: 28 January 2013: US FDA grants Takeda approval for three type 2 diabetes drugs).
Outlook and implications
The weakening of the yen has been a positive for all Japanese firms, with Takeda's investment in expanding overseas – through Nycomed, URL Pharma, and Multilabs – seeing revenues gain a significant boost. This has seen a range of adjustments made to end-of-year forecasts, with full-year net revenues now expected to reach JPY1,680 billion, a JPY90-billion upwards adjustment, while net income is expected to reach JPY95 billion for the year, an increase of JPY10 billion.
In China, Nesina will be promoted in partnership with Sanofi (France; see China - Japan - France: 24 April 2013: Sanofi and Takeda join forces in China's type 2 diabetes market). The type 2 diabetes market in China is a competitive one for Big Pharma, with Nesina taking on current market leader Glucobay (acarbose; Bayer, Germany), while Abbott (US) and Astra Zeneca (UK) are co-marketing Byetta (exenatide) and Onglyza (saxagliptin), and Merck KGaA (Germany) and Bristol-Myers Squibb (US) are co-marketing Glucophage (metformin). The firms are competing for the world's largest diabetes market of around 92.3 million adult sufferers, 58.5% of which are undiagnosed, and with 37.4 million Chinese adults expected to develop type 2 diabetes by 2030, according to the International Diabetes Federation. Economic growth and the government's increasing willingness to reimburse drugs for chronic diseases should see patients increasingly able to purchase newer treatments.