Major products Audited

In 2013, sales of the key products of the Merck Serono division developed as follows:

Merck’s top-selling drug Rebif®, which is used to treat relapsing forms of multiple sclerosis, achieved slight organic growth of 1.4% in 2013. This was especially attributable to its good performance in the first half of 2013, during which sales grew organically by 4.7%. Yet in the second half of 2013, Rebif® suffered an organic decline in sales, primarily in North America. Taking adverse foreign exchange effects of –2.9% into account, Rebif® sales decreased by –1.5% to € 1,865 million (2012: € 1,893 million). In North America, which generated 51% of Rebif® sales (2012: 52%) and is the largest market for this product, sales saw slight organic growth of 0.3% to € 956 million (2012: € 983 million). In particular, this was the result of a tougher competitive environment in North America in the second half of 2013, where lower sales volumes could not be completely compensated for by price increases. In Europe, sales of Rebif® grew organically by 2.8%, totaling € 745 million (2012: € 731 million). Including a foreign exchange impact of –0.9%, sales grew by a total of 1.9%. Consequently, Europe accounted for 40% of total Rebif® sales (2012: 39%). The Emerging Markets and the Rest of World regions posted organic increases in Rebif® sales of 1.1% and 5.4%, respectively, with adverse foreign exchange effects of –11.5% and –5.8%, respectively. Overall, this resulted in Emerging Markets sales declining by –10.4% to € 130 million (2012: € 145 million). In the Rest of World region, Merck Serono generated sales of € 34 million, as in 2012. At around 9%, the combined contribution of these two regions to Rebif® sales remained comparatively low.

In 2013, sales of the oncology drug Erbitux® showed organic growth of 5.9%. Including a foreign exchange impact of –6.5%, which primarily stemmed from the Japanese yen and Latin American currencies, sales declined slightly by € –5 million to € 882 million (2012: € 887 million). Merck Serono achieved organic growth in all three regions in which it holds the marketing rights. In 2013, 57% of Erbitux® sales were generated in Europe (2012: 56%), making it the top-selling region for this product. Erbitux® sales in this region grew organically by 0.5% in 2013, thereby totaling € 501 million, which includes adverse foreign exchange effects of –0.4% (2012: € 500 million). Despite strong organic growth of 8.9%, sales in Emerging Markets declined slightly to € 232 million (2012: € 236 million) as a result of currency headwinds of –10.3%. This region contributed 26% (2012: 27%) of total Erbitux® sales. At 18.8%, the Rest of World region generated the strongest organic growth for this oncology drug, delivering sales of € 149 million (2012: € 152 million). Posting organic growth of 22.1%, business in Japan performed well. However, this was canceled out by adverse exchange rate effects stemming from the weak Japanese yen against the euro. In particular, the approval of Erbitux® in head and neck cancer as well as higher market shares in other Erbitux® indications were the main drivers of the increase in organic sales.

Merck Serono | Sales and organic growth of key products – 2013

Sales of Gonal-f®, the leading recombinant hormone used in the treatment of infertility, totaled € 586 million in 2013 (2012: € 612 million). This decline was largely attributable to adverse foreign exchange effects of –3.5%. Gonal-f® sales saw a slight organic decrease of –0.7%. Strong organic growth in the Emerging Markets and Rest of World regions could not offset the weaker sales performance in Europe and North America, where the correlation between economic developments and the demand for fertility products remained visible. However, other products from the Fertility franchise achieved strong organic growth, thereby generating total organic sales growth of 2.4% for the franchise and, including adverse foreign exchange effects, sales of € 807 million (2012: € 817 million).

At € 394 million (2012: € 399 million), sales by the Endocrinology franchise, which mainly consists of products to treat metabolic and growth disorders, decreased slightly by –1.3% since organic growth of 2.1% was more than offset by an adverse foreign exchange impact of –3.4%. Sales of the growth hormone Saizen® saw an organic decline of –1.8% as well as negative foreign exchange effects of –4.0%. As a result, sales declined by a total of –5.8% to € 235 million. Merck Serono achieved double-digit organic growth rates with Serostim® for HIV-associated wasting, as well as with Kuvan® for the treatment of hyperphenylalaninemia, a metabolic disorder.

The General Medicine franchise (including CardioMetabolic Care), which commercializes Merck Serono’s products to treat cardiovascular diseases and diabetes, among others, generated organic sales growth of 6.5%. Including negative foreign exchange effects, sales amounted to € 2,005 million (2012: € 1,998 million). Overall, sales volumes in this business franchise developed well. This reflected the performance of the three leading product franchises, namely Glucophage® for the treatment of diabetes, the beta-blocker Concor®, and Merck’s portfolio for the treatment of thyroid disorders, all of which achieved high organic growth rates. However, negative exchange rate effects were registered here as well. Sales of Glucophage®, which grew organically by 4.8% primarily due to sales in the Emerging Markets region, totaled € 394 million (2012: € 399 million). Thanks mainly to strong demand in Emerging Markets and Europe, Concor® and thyroid products generated organic growth of 11.4% and 21.0%, respectively, posting sales of € 401 million (2012: € 380 million) and € 275 million, respectively (2012: € 234 million).