諾和諾德 (NVO) 2003 Q1 法說會逐字稿

Good morning and good afternoon, ladies and gentlemen, and welcome to the Novo Nordisk conference call. I would now like to turn over to your chairperson, Mr. Lars Revensorenson (ph). Please go ahead, sir, and I will be standing by for questions.

早安，下午好，女士們先生們，歡迎參加諾和諾德電話會議。現在我想請主席拉爾斯·雷文索倫森先生（博士）發言。先生，請繼續，我將隨時準備回答問題。

Thank you so much. Welcome to the Novo Nordisk conference regarding our results for the first quarter of 2003 released earlier today. My name is Lars Rebien Sorenson. I'm the CEO of Novo Nordisk. With me I have our CFO Jasper Brandgaard and Mars Krosgaard, our Chief Science Officer (inaudible) and our also Investor Relations Officer, Peter Haahr and (inaudible) Christian Kanstrup.

太感謝了。歡迎參加諾和諾德會議，會議內容涉及我們今天早些時候發布的 2003 年第一季的業績。我叫拉爾斯‧雷比恩‧索倫森。我是諾和諾德公司的執行長。和我一起的還有我們的財務長 Jasper Brandgaard 和 Mars Krosgaard、我們的首席科學長（聽不清楚）以及投資者關係長 Peter Haahr 和 Christian Kanstrup（聽不清楚）。

Today the earnings release is available on our home page www.novonordisk.com (http://www.novanordisk.com) along with the slides that we'll be using for this conference call. The conference call is scheduled to last approximately one hour and, as usual, we'll start with the presentation as outlined on slide number one. The Q&A session will begin in about 25 minutes.

今天，我們的主頁 www.novonordisk.com (http://www.novanordisk.com) 上發布了收益報告以及我們將在本次電話會議中使用的幻燈片。電話會議預計持續約一小時，像往常一樣，我們將從第一張投影片中概述的簡報開始。問答環節將在大約 25 分鐘後開始。

Please turn to slide number two. As always, I need to advise you that this call will contain forward-looking statements. Forward-looking statements are subject to risks and uncertainties that cause actual results of the firm (inaudible) from expectations. For further information on the risk factors, please see the press release and the slides prepared for this presentation. Also, please note that (inaudible) broadcast live and a replay will be made available on Novo Nordisk's Web site after the conference call.

請翻到第二張幻燈片。與往常一樣，我需要告知您，本次電話會議將包含前瞻性陳述。前瞻性陳述受到風險和不確定性的影響，這些風險和不確定性導致公司的實際結果（聽不清楚）與預期不符。有關風險因素的更多信息，請參閱新聞稿和為本次演示準備的幻燈片。另請注意，電話會議結束後，諾和諾德網站上將提供（聽不清楚）現場直播和重播。

Please turn to slide number three providing you with a highlight from this first quarter. Sales increased with 11 percent in the quarter measured in Danish kroner and 24 percent in local currencies. Operating profit increased by six percent to Danish kroner 1.32 billion in the first quarter of 2003. Adjusted from non-recurring items, operating profit increased by more than 15 percent despite the challenges caused by the weakening of our main (inaudible) currencies.'

請轉到第三張投影片，為您提供第一季的亮點。以丹麥克朗計算的本季銷售額成長了 11%，以當地貨幣計算的銷售額成長了 24%。 2003 年第一季度，營業利潤成長了6%，達到13.2 億丹麥克朗。儘管我們的主要（聽不清楚）貨幣貶值帶來了挑戰，但經非經常性專案調整後，營業利潤仍成長了15 % 以上。

We're satisfied with the strong performance in this first quarter; however, please not that when comparing this quarter to the first quarter of 2002, several factions have been impacting both sales and costs. When comparing sales, please bear in mind that the realized sales in the first quarter for 2002 were influenced by both performance and timing related issues relating to unusual weak sales.

我們對第一季的強勁表現感到滿意；然而，請注意，當將本季與 2002 年第一季進行比較時，有幾個因素對銷售和成本產生了影響。在比較銷售額時，請記住，2002 年第一季實現的銷售額受到與異常疲軟銷售相關的業績和時間相關問題的影響。

On the cost side, the development in the first quarter 2003 mirrors our cost expectations for the full year. The cautious (ph) development relative to the first quarter 2002 also reflects the impact on the cost base from the cost containment initiated in April, 2002. All in all, we believe we have placed solid (inaudible) for the full year performance with the first quarter. There is still a way to go with challenging benchmarks for the following quarters and, and it's seen, continuing ever-challenging currency environment.

在成本方面，2003 年第一季的發展反映了我們對全年成本的預期。相對於 2002 年第一季的謹慎（ph）發展也反映了 2002 年 4 月開始的成本控制對成本基礎的影響。總而言之，我們相信我們已經為全年業績奠定了堅實的基礎（聽不清楚）第一季。在接下來的幾個季度中，仍然有很長的路要走，以應對具有挑戰性的基準，並且可以看出，貨幣環境將持續充滿挑戰。

As a direct consequence of the continued depreciation of the main currencies (inaudible) expect to be to deliver low single-digit growth in operating profit. However, (inaudible) exposure of the main currencies, it now expects that net financial income will be realized at 700 million Danish kroner and, therefore, Novo Nordisk continues to expect net profit goal for 2003 to approach 10 percent.

主要貨幣持續貶值（聽不清楚）的直接後果預計將是營業利潤的低個位數成長。然而，由於（聽不清楚）主要貨幣的敞口，諾和諾德目前預計淨財務收入將實現7億丹麥克朗，因此，諾和諾德繼續預計2003年的淨利潤目標將接近10%。

There are several highlights from the pipeline in this quarter with the most exciting (inaudible) coming from (inaudible) the NN2211 project. Mars will fill you in on the details later in this conference call, both in terms of this project and our Novo serve and expansion program.

本季的管道有幾個亮點，其中最令人興奮的（聽不清楚）來自（聽不清楚）NN2211 項目。瑪氏將在本次電話會議稍後向您詳細介紹該項目以及我們的 Novo 服務和擴展計劃。

Turn to slide number four. Looking at the sales performance in the first quarter 2003, diabetes care was up 12 percent compared to 2002 whereas haemostasis management increased 16 percent. These two areas constitute approximately 85 percent of total sales and I'll get back to those on the following slides.

轉到第四張投影片。從2003年第一季的銷售業績來看，糖尿病照護比2002年成長了12%，而止血管理成長了16%。這兩個領域約佔總銷售額的 85%，我將在下面的幻燈片中回顧這些領域。

Growth hormone therapy was up 16 percent sales, were supported by underlying market growth in the United States, Europe and Japan and by market share gains, especially in the United States.

生長激素療法的銷售額成長了 16%，這得益於美國、歐洲和日本的基本市場成長以及市場份額的成長，尤其是在美國。

Our HRT business continued to be impacted by overall market contraction caused by the early termination mid-2002 of a U.S. (inaudible) initiative starting. The sales declined by 17 percent and apart from the overall market contraction, parallel trading in Europe impacted sales growth negatively. In this negative market environment, Novo Nordisk has been able to gain market shares. Novo Nordisk offers a complete (inaudible) of low-dose products based on natural hormones for oral as well as local treatment, all of which are in line with the recent recommendations issued by the authorities in the United States.

我們的 HRT 業務持續受到美國（聽不清楚）啟動計畫於 2002 年中期提前終止而導致的整體市場萎縮的影響。銷售額下降了 17%，除了整體市場萎縮之外，歐洲的平行貿易也對銷售額成長產生了負面影響。在這種負面的市場環境下，諾和諾德卻能獲得市場佔有率。諾和諾德提供一整套（聽不清楚）基於天然激素的低劑量產品，用於口服和局部治療，所有這些產品均符合美國當局最近發布的建議。

In light of these recommendations, Novo Nordisk product (inaudible) has more than doubled its market share. In the United States and in Europe (inaudible) has become the fastest HRT product since mid-2002. The depreciation of our main invoicing currencies had a major impact on our sales growth measures in Danish kroner of 13 percent.

根據這些建議，諾和諾德產品（聽不清楚）的市佔率增加了一倍以上。在美國和歐洲（聽不清楚）已成為自 2002 年中期以來最快的 HRT 產品。我們主要計價貨幣的貶值對我們以丹麥克朗計算的銷售成長產生了 13% 的重大影響。

Please turn to slide number five which illustrates the significant currency impact (inaudible) throughout the area. (inaudible) with growth within diabetes care and haemostasis management being half during to the unfavorable currency development.

請翻到第五張幻燈片，該幻燈片說明了整個地區貨幣的重大影響（聽不清楚）。 （聽不清楚）由於金錢發展不利，糖尿病照護和止血管理領域的成長減半。

Turn to slide number six for an overview of sales by region. Growth in Europe, 13 percent, needs to be seen in the light of the weak first quarter of last year. But we also have a negative currency effect from most (inaudible) British pound and Polish zloty. Underlying sales growth in Europe adjusted for the destocking in the first quarter of 2002 and the negative impact from currencies is close to 10 percent. North American sales continues to show solid double-digit growth despite an impact from an 18 percent deprecation of the U.S. dollar. Sales in Japan grew three percent due to the sound underlying performance being able to compensate for almost 10 percent depreciation of the Japanese yen versus Danish kroner. We continue to see strong growth in international operations where sales were up 10 percent, also in three percent measured in local currencies.

請參閱第六張投影片，以了解按地區劃分的銷售額概覽。鑑於去年第一季的疲軟，歐洲的成長率為 13%。但大多數（聽不清楚）英鎊和波蘭茲羅提也對貨幣產生了負面影響。歐洲的基本銷售成長根據 2002 年第一季的去庫存調整以及匯率的負面影響接近 10%。儘管受到美元貶值 18% 的影響，北美銷售額仍保持兩位數的穩健成長。由於良好的基本業績能夠彌補日圓兌丹麥克朗貶值近 10% 的影響，日本的銷售額成長了 3%。我們繼續看到國際業務的強勁成長，銷售額成長了 10%，以當地貨幣計算也成長了 3%。

Please turn to slide number seven illustrating the currency impact per region. Once again, the significant currency impact is seen. Growth in North America is reduced by 25 percent (inaudible) due to currencies, whereas the impact of growth in international operations is 23 percent (inaudible).

請參閱第七張投影片，說明每個地區的貨幣影響。再次看到了重大的貨幣影響。由於匯率問題，北美地區的成長下降了 25%（聽不清楚），而國際業務成長的影響則為 23%（聽不清楚）。

Please turn to slide number eight. This provides you with highlights from our diabetes business. Diabetes care increased by 12 percent as recorded and 24 percent in local currencies in the first quarter 2003. (inaudible) in terms of performance for North America, international operations and Europe.

請翻到第八張幻燈片。這為您提供了我們糖尿病業務的亮點。 2003 年第一季度，根據記錄，糖尿病護理增長了 12%，以當地貨幣計算增長了 24%（聽不清楚），就北美、國際業務和歐洲的業績而言。

In North America, our insulin (inaudible) contributed to our goals. Profit in North America was, however, positively impacted by general price increases during 2002 and by some stocking of human insulin and (inaudible) in connection with the U.S. (inaudible) and (inaudible) and (inaudible) in vials.

在北美，我們的胰島素（聽不清楚）為我們的目標做出了貢獻。然而，北美的利潤受到 2002 年總體價格上漲以及美國（聽不清楚）和（聽不清楚）和（聽不清楚）小瓶中人類胰島素和（聽不清楚）的一些庫存的積極影響。

The market data for the first month of 2003 confirms that our market share in the United States continues to grow in the first quarter. Sales of insulin and delivery systems within international operations increased by 28 percent in local currencies compared to the first quarter of 2002. Sales growth was significantly impacted by a negative currency environment, especially (inaudible), the Turkish llira and the Chinese yen. Growth measured in Danish kroner was six percent.

2003年第一個月的市場數據證實，第一季我們在美國的市佔率持續成長。與2002 年第一季相比，國際業務中胰島素和輸送系統的銷售額以當地貨幣計算增長了28%。銷售額增長受到不利貨幣環境的顯著影響，特別是（聽不清楚）土耳其里拉和人民幣。以丹麥克朗計算的成長率為百分之六。

Growth was 16 percent for insulin and delivery systems in Europe can to some extent be attributed to the weak first quarter last year, but we are seeing decent growth rates in the European insulin market. During the last year, Novo Nordisk's market position in Europe has been strengthened by a continued rollout of (inaudible) which is launched in close to 15 countries. Together with (inaudible) these products have been key in supporting our market share in Europe.

歐洲胰島素和輸送系統的成長率為 16%，在某種程度上可以歸因於去年第一季的疲軟，但我們看到歐洲胰島素市場的成長率不錯。去年，諾和諾德在歐洲的市場地位因在近 15 個國家持續推出（聽不清楚）而得到加強。這些產品與（聽不清楚）一起是支持我們在歐洲市場份額的關鍵。

Market data from the first month of 2003 indicates that our market position in the European region is on the (inaudible) by continuous penetration of (inaudible) in terms of volume and value.

2003 年第一個月的市場數據表明，我們在歐洲地區的市場地位在數量和價值方面不斷滲透（聽不清楚）。

Turn to slide number nine which provides you with an overview of the insulin market. This slide is based on (inaudible) annual total market figures for the four quarters ending December, 2002. We see solid growth in all regions and the worldwide growth of 5.3 percent continues to be above our long-term guidance of five percent. It's also nice to see that Novo Nordisk is growing above world market growth. Moreover, we are pleased to see that U.S. markets continue to grow. Overall, Novo Nordisk has realized a slight increase in world market share, with a slight decline in market share in Japan being more than counterbalanced by increased market share in the United States.

請參閱第九張幻燈片，其中概述了胰島素市場。這張投影片是根據截至2002 年12 月的四個季度的（聽不清楚）年度總市場數據。我們看到所有地區都實現了穩健成長，並且全球5.3% 的成長繼續高於我們5% 的長期指導。很高興看到諾和諾德的成長速度超過了全球市場的成長速度。此外，我們很高興看到美國市場持續成長。總體而言，諾和諾德的全球市場份額實現了小幅增長，其中日本市場份額的小幅下降被美國市場份額的增長所抵消。

The (inaudible) growth plays a very important for the Novo Nordisk insulin business. It's also important for us to realize our fair share of the value upgrades, both in terms of upgrading to more advanced delivery systems and to insulin analogs.

（聽不清楚）成長對諾和諾德胰島素業務非常重要。對我們來說，實現價值升級的公平份額也很重要，無論是升級到更先進的輸送系統還是胰島素類似物。

Turn to slide number 10 which provides you with insights on our short-acting insulin analog (inaudible) is performing in Europe on a quarterly basis. Overall, the short-acting segment as such is still increasing in size and globally it now constitutes 28 percent in terms of volume. As can be seen, that's on the left hand side of the slide, the conversion within this segment from human insulin towards insulin analogs is continuing in Europe and currently approximately 42 percent of insulin volumes have been converted to analogs. An interesting observation from the latest quarter in market data is that within the segment of short-acting insulin, our product (inaudible) holds a market share of 14.8 percent in the fourth quarter of 2002. Late 2001 we launched the same product in the United States under the name of Novo (inaudible).

請參閱第 10 張投影片，該投影片為您提供了有關我們的短效胰島素類似物（聽不清楚）每季在歐洲的表現的見解。總體而言，短效細分市場的規模仍在擴大，目前在全球佔 28%。從幻燈片的左側可以看出，在歐洲，該細分市場中從人類胰島素向胰島素類似物的轉換仍在繼續，目前大約 42% 的胰島素量已轉換為類似物。從最新季度的市場數據中觀察到的一個有趣現像是，在短效胰島素領域，我們的產品（聽不清楚）在2002 年第四季佔據了14.8% 的市場份額。2001 年末，我們在美國推出了相同的產品國家名稱為 Novo（聽不清楚）。

Please turn to slide number 11 for an update on how this product is performing in this very important region. Again, it's worth observing that the conversion of analogs is continuing and that our product continues to (inaudible) market share.

請參閱第 11 張投影片，以了解該產品在這個非常重要的地區的最新表現。同樣，值得注意的是，類似物的轉換仍在繼續，我們的產品繼續保持（聽不清楚）市場份額。

So much about our diabetes care franchise for now and let's turn to the next slide updating on our performance within haemostasis management. Though (inaudible) sales increased 16 percent in the first quarter. In local currencies, the increase was 32 percent. Sales growth in the first quarter was primarily realized in North America, followed by Europe; however, all regions contributed to growth.

關於我們的糖尿病照護專營權現在就這麼多，讓我們轉向下一張投影片，更新我們在止血管理方面的表現。儘管（聽不清楚）第一季銷售額成長了 16%。以當地貨幣計算，增幅為 32%。第一季銷售成長主要實現在北美，其次是歐洲；然而，所有區域都對成長做出了貢獻。

Several factor contributed to sales growth of (inaudible) in the quarter. The larger segment of (inaudible) is the use of the product for congenital bleeding and this segment still delivering a major part of the growth in sales. However, the increased awareness of benefits of using (inaudible) in connection (inaudible) hemophilia has led to an increased use of (inaudible) for this patient group. This has contributed to the growth as well. Finally, sales have been positively affected by the increase of the situational use of (inaudible). This is a (inaudible) for approximately 10 percent of the total of (inaudible) sales.

有幾個因素促成了本季銷售額的成長（聽不清楚）。較大的部分（聽不清楚）是將該產品用於先天性出血，該部分仍是銷售額成長的主要部分。然而，人們越來越認識到使用（聽不清楚）與（聽不清楚）血友病相關的好處，導致該患者群體使用（聽不清楚）的情況增加。這也促進了成長。最後，（聽不清楚）情境使用的增加對銷售產生了正面影響。這（聽不清楚）約佔總銷售額（聽不清楚）的 10%。

These were my introductory remarks regarding sales in the first quarter. Mars Krosgaard, our Chief Science Officer will now provide you with an update on our R&D activities.

這是我對第一季銷售情況的介紹性發言。我們的首席科學官 Mars Krosgaard 現在將為您提供我們研發活動的最新資訊。

Thank you, Lars. On the following two slides, the updated Novo Nordisk development pipeline is shown. First, the diabetes pipeline. For (inaudible) I'm happy to be able to inform you that the trade name of our (inaudible) insulin analog is Libamere (ph). Yet another large scale with Libamere (ph) has been completed, this time comparing basal bolus therapy using Libamer (ph) and Novarapid (ph) and comparing it with traditional human basal bolus therapy in Type I diabetes.

謝謝你，拉爾斯。下面兩張幻燈片顯示了更新後的諾和諾德開發流程。首先，糖尿病管道。對於（聽不清楚）我很高興能夠通知您，我們的（聽不清楚）胰島素類似物的商品名是 Libamere (ph)。 Libamere (ph) 的另一項大規模試驗已經完成，這次比較了Libamer (ph) 和Novarapid (ph) 的基礎推注療法，並將其與I 型糖尿病的傳統人體基礎推注療法進行了比較。

For the all the four important aspects of insulin therapy, glucose regulation, hypoglycemia, predictability and weight control (inaudible) significant improvement in the outcomes was seen for the analog treated patients, providing the first evidence that it is actually possible to (inaudible) on all key parameter simultaneously. The human (ph) (inaudible) derivative (inaudible) is a project that I'll revert to in a minute.

對於胰島素治療的所有四個重要方面，葡萄糖調節、低血糖、可預測性和體重控制（聽不清楚），模擬治療患者的結果均得到顯著改善，這提供了第一個證據，表明實際上有可能（聽不清楚）所有關鍵參數同時進行。人類（ph）（聽不清楚）衍生品（聽不清楚）是一個我將在一分鐘內恢復的項目。

On the next slide, which I will ask you to turn to, you can see the status of our (inaudible) pipeline and hence, our NovoSeven expansion program. With an upper GI bleeding, the positive data from the first study have led us to conclude that we will continue the development of NovoSeven targeting visceral bleeding in liver cirrhotic patients. With a (inaudible) study in patients with cirrhosis has now been completing concluding that when using a relatively low dose regimen in these patients, NovoSeven was safe but there no effect on transfusion requirement in the doses given in this study.

在我將要求您翻閱的下一張投影片上，您可以看到我們（聽不清楚）管道的狀態，以及我們的 NovoSeven 擴充計畫。對於上消化道出血，第一項研究的積極數據使我們得出結論，我們將繼續開發針對肝硬化患者內臟出血的 NovoSeven。一項針對肝硬化患者的（聽不清楚）研究現已完成，得出的結論是，當對這些患者使用相對較低的劑量方案時，NovoSeven 是安全的，但本研究中給出的劑量對輸血需求沒有影響。

We believe that the explanation of the difference between this result and the positive findings from the previous (inaudible) in non-cirrhotic patients may relate to the fact that the cirrhotic liver is fibrotic and is elastic; thus, in cirrhosis and only in cirrhosis, not allowing for the blood vessel retraction that is needed for good haemostasis. Both within emergency bleeds and surgical bleeds, as exemplified by the recent (inaudible) on NovoSeven in prostate surgery, Novo Nordisk continues to believe strongly in the potential of NovoSeven.

我們認為，這一結果與先前（聽不清楚）非肝硬化患者的陽性發現之間的差異的解釋可能與肝硬化肝臟纖維化且有彈性有關；因此，在肝硬化中且僅在肝硬化中，不允許良好止血所需的血管回縮。無論是在緊急出血或手術出血方面，例如最近（聽不清楚）NovoSeven 在前列腺手術中的應用，諾和諾德仍然堅信 NovoSeven 的潛力。

The trials with (inaudible) are still on track for delivering results according to the previously-announced timelines. With emergency bleeding associated with EG (ph) severe trauma, we have now seen the emergence of positive statements, or even treatment accommodations, for NovoSeven as a last resort from health authorities in at least three countries. In this context, Novo Nordisk growth with the ongoing expansion program remain committed to providing clinical guidance for optimal use of NovoSeven in areas where of proof of concept is achieved.

（聽不清楚）的試驗仍在按照先前宣布的時間表交付結果。對於與 EG (ph) 嚴重創傷相關的緊急出血，我們現在已經看到至少三個國家的衛生當局對 NovoSeven 做出了積極的聲明，甚至是治療安排，將其作為最後的手段。在此背景下，諾和諾德透過持續的擴張計畫繼續致力於為 NovoSeven 在已實現概念驗證的領域的最佳使用提供臨床指導。

Within our growth hormone portfolio, the European Agency for the Evaluation of Medicinal Products (inaudible) last month issued a positive opinion on the use of Norditropin Simplex (ph) in short children found small for gestational age and failing to show catch-up growth at two years of age. Consequently, we expect the first national approval for SGA (ph)t treatment within the next six months.

在我們的生長激素產品組合中，歐洲藥品評估機構（聽不清楚）上個月對使用Norditropin Simplex (ph) 發表了積極意見，認為對於小於胎齡且未能表現出追趕性生長的矮小兒童使用Norditropin Simplex (ph)兩歲了。因此，我們預計 SGA (ph)t 治療將在未來六個月內首次獲得國家批准。

Please turn to the next slide. Following the two previous 12-week studies on the human PO1 (ph) derivative, Lirepatide (ph), we are pleased that we now provide you with highlights from the final Phase II (ph) trial. In this randomized, double blind, dose hydration study among 144 primarily obese people with poorly controlled Type II diabetes, there was inclusion of a comparison between (inaudible) against (inaudible) plus Metformin. After only five weeks of treatment, statistical superiority in favor of the Lirepatide (ph) group was achieved, both for the primarily efficacy in (inaudible) fasting glucose and for body weight, which in the case of the Lirepatide (ph) was seen to drop in spite of the improved glucose control. Regarding side effects, the positive (inaudible) findings were observed in the absence of hypoglycemia, antibody formation or injection site reactions.

請翻到下一張投影片。繼先前兩項針對人類 PO1 (ph) 衍生物 Lirepatide (ph) 的 12 週研究之後，我們很高興現在為您提供最終 II 期 (ph) 試驗的亮點。在這項隨機、雙盲、劑量水合作用研究中，對144 名患有II 型糖尿病控制不佳的主要肥胖者進行了研究，其中包括（聽不清楚）與（聽不清楚）加二甲雙胍之間的比較。僅經過五週的治療，就取得了有利於利瑞帕肽(ph) 組的統計優勢，無論是在（聽不清楚）空腹血糖還是體重方面的主要療效，在利瑞帕肽(ph) 的情況下，這都被認為是儘管血糖控制有所改善，但仍下降。關於副作用，在沒有低血糖、抗體形成或註射部位反應的情況下觀察到正面（聽不清楚）的結果。

For the gastrointestinal side effects, most patients reporting these exhibited a dose hydration related transient nausea that was not prohibitive to further dose escalation or therapy with the compound within the entire dose range examined. Thus, the strong efficacy profile of Lirepatide (ph) is seen on the background of V9 (ph) side effect profile.

對於胃腸道副作用，大多數報告這些副作用的患者表現出與劑量水合作用相關的短暫噁心，這並不妨礙在所檢查的整個劑量範圍內進一步增加劑量或使用該化合物進行治療。因此，在 V9 (ph) 副作用概況的背景下，可以看到 Lirepatide (ph) 的強功效概況。

Availability of the previous and present Phase II (ph) study data that together covered the full dose response group begs the obvious question, what will the overall profile of Lirepatide (ph) be within the (inaudible) of Type II diabetes therapies?

先前和目前II 期(ph) 研究數據的可用性共同涵蓋了完整的劑量反應組，這引出了一個明顯的問題：利瑞帕肽(ph) 的總體概況在II 型糖尿病治療（聽不清楚）中的情況如何？

I'll ask you to turn to the next slide when addressing this issue. Since superior control of fasting glucose and previously also post-prandial glucose, has been shown for Lirapatide (ph) as compared (inaudible), we believe that the potential to reduce hemoglobin A1C will exceed that observed for all anti-diabetic drugs. Importantly, this may be achieved in the presence of weight reduction as opposed to the weight gain see, for instance, in (inaudible). The intriguing pre-clinical finding of (inaudible) potential being preserved or even increasing Lirepatide (ph) as a consequence of more new beta cells being formed than old ones being destroyed, will be explored in the clinical Phase III Lirepatide (ph) program.

在解決這個問題時，我會請您翻到下一張投影片。由於利拉帕肽 (ph) 相比（聽不清楚）對空腹血糖和餐後血糖的控制效果更好，我們相信降低血紅蛋白 A1C 的潛力將超過所有抗糖尿病藥物所觀察到的潛力。重要的是，這可以在體重減輕的情況下實現，而不是體重增加，例如參見（聽不清楚）。有趣的臨床前發現是，由於形成的新β 細胞多於被破壞的舊β 細胞，因此利瑞帕肽(ph) 的潛力被保留甚至增加，這一有趣的臨床前發現將在臨床III 期利瑞帕肽(ph) 計劃中進行探索。

The V9 (ph) side effect profile of Lirepatide (ph) shown on this slide, has already been discussed. So the final point to make here is that during therapy with the one (inaudible) human (inaudible) derivative, frequent blood glucose monitoring would not be needed on the basis of hypoglycemia risk since the Lirepatide (ph) has a built-in glucose dependence in its mechanism of action.

本投影片所示的利瑞帕肽 (ph) 的 V9 (ph) 副作用概況已經討論過。因此，這裡要指出的最後一點是，在使用一種（聽不清楚）人類（聽不清楚）衍生物治療期間，基於低血糖風險，不需要頻繁監測血糖，因為利瑞帕肽（ph）具有內建的葡萄糖依賴性在其作用機制中。

With regard to positioning, diabetes management by diet and exercise has traditionally been followed by sequential addition of oral diabetic drugs up until the point in time the diabetes function is so poor as to warrant insulin monotherapy (ph), or add on (inaudible) therapy.

關於定位，傳統上透過飲食和運動進行糖尿病管理，然後依次添加口服糖尿病藥物，直到糖尿病功能很差以至於需要胰島素單藥治療（ph）或附加（聽不清楚）治療的時間點。

In the case of Lirepatide (ph), a promising profile that is emerging is one that seems to justify combination therapy at any point in time from the first (inaudible) and onwards until the phase where insulin monotherapy (ph) is warranted. Needless to say, there's at least one further area (inaudible) in Type II diabetes, (inaudible) through (inaudible) protection. This is an area that gives Lirepatide (ph) the potential to differentiate itself further from existing therapies, but long-term Phase III (ph) studies are needed to shed light on the extent to which the human (inaudible) derivative can meet also this need of the patients.

就利瑞帕肽 (ph) 而言，正在出現的一個有希望的概況似乎證明了從最初（聽不清楚）一直到需要胰島素單一療法 (ph) 的階段的任何時間點聯合治療的合理性。不用說，II 型糖尿病至少還有另一個領域（聽不清楚），即透過（聽不清楚）保護。這一領域使 Lirepatide (ph) 有可能進一步區別於現有療法，但需要長期的 III 期 (ph) 研究來闡明人類（聽不清楚）衍生物在多大程度上也能滿足這一要求患者的需要。

I'll now hand over the work to Jasper.

我現在將把工作交給賈斯柏。

Thank you, Mats. Please turn to slide 17. Operating profit increased six percent to 1 billion 320 million in the first quarter of 2003. Adjusting for non-recurring items, operating profits increased by more than 15 percent despite the challenges caused by the weakening of our main invoice incurrences. Net financial showed a net income of 330 million in the first quarter of 2003, compared to 17 million in the first quarter of 2002.

謝謝你，馬茨。請看投影片17. 2003 年第一季營業利潤成長了6%，達到10 億3.2 億。調整非經常性項目後，儘管主要發票收入減弱帶來了挑戰，但營業利潤仍成長了15% 以上。 。淨財務顯示，2003年第一季淨利為3.3億美元，而2002年第一季為1700萬美元。

Novo Nordisk recorded net foreign exchange gains of 332 million, primarily related to our hedging of the U.S. dollar, the Japanese yen and the British pound. The tax rate for the quarter is set at 34 percent, down from 35 percent first quarter last year.

諾和諾德錄得淨外匯收益3.32億，主要與我們對美元、日圓和英鎊的對沖有關。本季稅率定為 34%，低於去年第一季的 35%。

Please turn to the next slide for an update on our currency exposure. As you have heard throughout our presentation, changes in currency rates have a significant impact on our results. However, we do hedge our main currency so that we, short term, will be able to compensate for the negative impact on operating profit.

請翻到下一張投影片，了解我們貨幣風險的最新情況。正如您在我們的整個演示中所聽到的那樣，貨幣匯率的變化對我們的業績產生重大影響。然而，我們確實對我們的主要貨幣進行對沖，以便我們在短期內能夠彌補對營業利潤的負面影響。

At the end of the first quarter, you will notice that hedged future expected cash flows related to the U.S. dollar, the Japanese yen 18 months ahead, whereas the British pound was hedged 10 months ahead. These hedging periods are slightly increased compared to 6 February, 2003.

在第一季末，你會注意到，對沖了與美元相關的未來預期現金流量，對沖了未來 18 個月的日元，而對沖了提前 10 個月的英鎊。與 2003 年 2 月 6 日相比，這些對沖期略有增加。

Please turn to the next slide for an outlook for 2003. Currencies will also in 2003 have a significant impact on the reported growth reflecting the continued strengthening of the Danish kroner versus our main currencies. We now expect operating profit to grow by a low single-digit percentage rate in 2003. However, adjusting for the significant currency impact in 2003, we continue to expect the underlying operating profit goal to be close to 20 percent, as also stated in connection with the release of our full year results for 2002 in February.

請翻到下一張投影片來展望 2003 年。2003 年的貨幣也將對所報告的成長產生重大影響，反映出丹麥克朗相對於主要貨幣的持續走強。我們現在預計 2003 年營業利潤將以較低的個位數百分比增長。然而，根據 2003 年重大貨幣影響進行調整後，我們繼續預計基本營業利潤目標將接近 20%，如相關內容所述我們在二月份發布了2002 年全年業績。

As noted, we have, however, hit cash flow for 2003 in relation to the U.S. dollar, the Japanese yen and the British pound. And, hence, the negative influence from the depreciation of those main currencies versus the Danish kroner on operating profit will be offset by currency hedging gains included in the financial income. Therefore, net financial income is now expected at the level of 700 million for the year. As the hedging income is balancing the expected negative impact on operating profit from the negative development in our main invoicing currencies, Novo Nordisk continues to expect net profit growth to approach 10 percent.

然而，如前所述，我們已經達到了 2003 年相對於美元、日圓和英鎊的現金流量。因此，這些主要貨幣兌丹麥克朗貶值對營業利潤的負面影響將被財務收入中包含的貨幣對沖收益所抵銷。因此，目前預計全年財務淨收入為7億水準。由於對沖收入正在平衡主要計價貨幣的負面發展對營業利潤的預期負面影響，諾和諾德繼續預期淨利潤成長將接近 10%。

As usual, the expectations are given based on the assumption that currency exchange rates remain at the current levels for the rest of 2003. This concludes our presentation of the financial results. Lars Rebien Sorenson will now moderate the Q&A session.

與往常一樣，預期是基於 2003 年剩餘時間貨幣匯率保持在當前水準的假設而給出的。我們對財務表現的介紹到此結束。拉爾斯雷比恩索倫森 (Lars Rebien Sorenson) 現在將主持問答環節。

Ladies and gentlemen, we will now poll for questions. If you have a question, please press the number one on your telephone keypad and it's the hash or pound sign to cancel. Once again, that's one to ask a question and the hash or pound sign to cancel.

女士們先生們，我們現在將進行投票提問。如有疑問，請按電話鍵盤上的數字一，即井號或井號來取消。再一次，這是一個提出問題和取消的井號或井號。

The first question today comes from Marten Talcoy (ph). Please go ahead, announcing your company name.

今天的第一個問題來自 Marten Talcoy（博士）。請繼續宣布您的公司名稱。

Good day. This is Martin Talcoy (ph) at Danske Bank. I have three questions. Firstly, regarding NovoSeven. As you said the data you released today there was no effect and, of course, you also said that this wasn't contrary to the result we saw on non-cirrhotic patients undergoing liver resection. But in this study, you only show borderline statistic significant effect. You have previously said that you expect that the sales (inaudible) will both data driven and indication driven. Have you changed your view that this will be more and more data driven than you had expected before?

再會。我是丹麥銀行的馬丁·塔爾科伊（Martin Talcoy）。我有三個問題。首先，關於NovoSeven。正如您所說，您今天發布的數據沒有效果，當然，您也說這與我們在接受肝切除的非肝硬化患者身上看到的結果並不矛盾。但在這項研究中，您只顯示了臨界統計顯著效應。您之前曾說過，您預計銷售（聽不清楚）將由數據驅動和指示驅動。您是否改變了您的觀點，即這將比您之前預期的越來越多地由數據驅動？

Then with regard to price increases, we have seen price increases in U.S. on your insulin franchise for several years and it has been quite significant this year and 2002 as well. Do you think this can continue going forward?

然後關於價格上漲，我們已經看到你們的胰島素特許經營權在美國的價格上漲了好幾年，今年和 2002 年的漲幅也相當大。您認為這樣的情況還能繼續發展下去嗎？

Then also on price increases, I know there has also been some price increases on NovoSeven. What kind of impact has that had on your growth on NovoSeven this quarter?

然後還有價格上漲，我知道 NovoSeven 也有一些價格上漲。這對本季 NovoSeven 的成長有何影響？

And finally on your DOP1 (ph) analogue, you say that you will go into Phase III in the mid-summer of 2004. That is more than one year from now. What is taking so long for you to design the study for the Phase III trials? And also, in your report you say that you're currently optimizing the reduction process for NN211 (ph) including upscale and final culmulation (ph). Could you elaborate a bit more on that?

最後，關於您的 DOP1 (ph) 類似物，您說您將在 2004 年仲夏進入 III 期。那是一年多後的事了。你們為什麼花了這麼長時間來設計 III 期試驗的研究？而且，在您的報告中，您說您目前正在優化 NN211 (ph) 的還原過程，包括高檔和最終累積 (ph)。能詳細說明一下嗎？

Thank you very much, Martin (ph). This is Lars Rebien. I would like to moderate the Q&A session and here's a whole list of question. There's two which I would like to refer to Mars Krosgaard -- one is on NovoSeven -- the fact that we did not see any effect on cirrhotic liver patients as opposed a trending towards an effect on the non-cirrhotics, that leading us to have a different view on the future development of NovoSeven sales; as to whether it's going to be data or indication driven.

非常感謝你，馬丁（ph）。我是拉爾斯·雷比恩。我想主持問答環節，這裡有一個完整的問題清單。有兩個我想參考 Mars Krosgaard 的——一個是在 NovoSeven 上的——事實上，我們沒有看到對肝硬化患者有任何影響，而不是對非肝硬化患者有影響的趨勢，這導致我們對NovoSeven銷售未來發展有不同看法；至於是數據驅動還是指示驅動。

And the second one to Mars, I would like to attempt to answer is the question related to the efforts (inaudible) to development, why is it taking so long -- almost 12 months -- before we can get into Phase III (ph).

第二個去火星的問題，我想嘗試回答的是與開發工作（聽不清楚）相關的問題，為什麼要花這麼長時間——幾乎 12 個月——我們才能進入第三階段（ph） 。

Then there is the price increase issue in the U.S. and on (inaudible) which I will deal with myself. But why don't you start, Mars?

然後是美國的價格上漲問題（聽不清楚），我將自己處理。但為什麼不開始呢，火星？

Right. Well, first of all to address the NovoSeven issue, there is no doubt that as time goes by, we become more and more informed, both about mechanism of action of NovoSeven and also where NovoSeven therapy in which doses will actually pay off and, vis-a-vies the first hepatectomy study in the non-cirrhotics. It is true that a single dose of a heamophilia range, 80mcg/kl, gave borderline significant results in the actions of side effects. And that led us to conclude that we could actually continue that development, either upping the dose or giving maybe two administrations.

正確的。好吧，首先要解決 NovoSeven 問題，毫無疑問，隨著時間的推移，我們越來越了解 NovoSeven 的作用機制，以及 NovoSeven 治療的劑量實際上會在哪些方面獲得回報，以及-a-競爭第一個針對非肝硬化患者的肝切除研究。確實，血友病範圍的單一劑量（80mcg/kl）在副作用方面產生了臨界顯著結果。這使我們得出結論，我們實際上可以繼續這種開發，要么增加劑量，要么進行兩次給藥。

Now what we are saying today is that we are not continuing the (inaudible) in the cirrhotic patients based on the fact that in this study, we did not see any effect. Now there might be several reasons of which I have given you. One suggestion, mainly the fact that the liver becomes rubber-like, so to speak, during the cirrhosis meaning that the first process of haemostasis, namely that the blood vessels actually physically retract causing the clots to be more easily formed physically is one that is not indicative of any other indication with any elective surgery or other areas. Hence, this is a stand-alone situation where we have come to realize that NovoSeven will not proceed further in the area of hepatectomy in the cirrhotics.

現在我們今天要說的是，我們不會在肝硬化患者中繼續（聽不清楚）這項研究，因為在這項研究中，我們沒有看到任何效果。現在我給你的可能有幾個原因。一個建議，主要是肝臟在肝硬化期間變得像橡膠一樣，這意味著止血的第一個過程，即血管實際上物理收縮，導致血栓更容易在物理上形成，這是一個不表明任何擇期手術或其他領域的任何其他適應症。因此，這是一個獨立的情況，我們已經意識到 NovoSeven 不會在肝硬化患者的肝切除領域進一步開展業務。

I have said nothing about the hepatectomy in non-cirrhotics, but we are still pleased with the results that we got in the first study. Of course, the dosing regimen also bore testimony to the fact that the regulators in the early days would only allow low dose administration because the safety data (inaudible) was rather modest at that point in time.

我沒有提及非肝硬化患者的肝切除術，但我們仍然對第一項研究的結果感到滿意。當然，給藥方案也證明了這樣一個事實：早期監管機構只允許低劑量給藥，因為當時的安全數據（聽不清楚）相當有限。

And Lirepatide?

利瑞帕肽呢？

Yes. Well, first of all it's quite normal that it takes between three and six months from the end of the Phase II (ph) to initiation of Phase III trials. Since results from the latest trial showed the doses of Lirepatide (ph) need to be increased to get the optimum efficacy compared to what was predicted from the first trial, some additional development work is required before entering Phase III (inaudible).

是的。首先，從第二階段（ph）結束到第三階段試驗開始需要三到六個月的時間，這是很正常的。由於最新試驗的結果表明，與第一次試驗的預測相比，需要增加 Lirepatide (ph) 的劑量才能獲得最佳療效，因此在進入 III 期之前需要進行一些額外的開發工作（聽不清楚）。

And the (inaudible) supply forecast are thus significantly higher than we currently had anticipated. And also, to maintain the convenience for the patients, we need to minimize the injection volume of Lirepatide (ph). And this will require further formulation development. Thus, we are in a situation where we want (A) to optimize Lirepatide (ph) manufacturing process of the active product ingredient, and (B) to draw up (ph) product for Phase III (ph) including upscaling and work on the final formulation.

因此，（聽不清楚）供應預測明顯高於我們目前的預期。而且，為了維持患者的便利，我們需要盡量減少利瑞帕肽（ph）的注射量。這將需要進一步的配方開發。因此，我們現在的情況是，我們希望 (A) 優化利瑞帕肽 (ph) 活性產品成分的製造工藝，(B) 為 III 期 (ph) 制定 (ph) 產品，包括升級和致力於最終配方。

All together, this leads us to an expected start of Phase III (ph) by mid-2004. This is the situation, but we're happy with the data.

總而言之，這使我們預計將於 2004 年中期開始第三階段（ph）。情況就是這樣，但我們對數據感到滿意。

Thank you so much, Mars. Then to the pricing issue in the United States, Nova Nordisk has, in general, followed the market leader in the United States in terms of price development on insulin. The major value change that you see in the U.S. insulin market is one which is caused by the upgrade to (inaudible) the conversion from human insulin to insulin analogues. And we do believe that that conversion and that price effect, if you want, is indeed sustainable as we would be expecting that we would see continued penetration of analogues into the U.S. market.

非常感謝你，火星。然後是美國的定價問題，諾德諾德在胰島素的價格製定方面總體上追隨了美國市場領導者的步伐。您在美國胰島素市場看到的主要價值變化是由人類胰島素向胰島素類似物的升級（聽不清楚）引起的。我們確實相信，如果你願意的話，這種轉換和價格效應確實是可持續的，因為我們預計我們會看到類似物繼續滲透到美國市場。

Over beyond that, human insulin prices have changed approximately three to four percent on an annual basis over the last years, and we do believe that that is a sustainable price increase in the United States.

除此之外，過去幾年中人類胰島素價格每年變化約 3% 至 4%，我們確實相信美國的價格上漲是可持續的。

With regard to NovoSeven, it is correct that after the price increase in the United States of about five percent from January 1, 2003, the overall estimated impact is from two to three percent on the overall NovoSeven sales and somewhat more, of course, if you primarily look at the U.S. business for the first quarter.

關於 NovoSeven，正確的是，自 2003 年 1 月 1 日起，在美國價格上漲約 5% 後，總體估計對 NovoSeven 總銷售額的影響為 2% 至 3%，當然，如果您主要關注第一季度的美國業務。

Thank you, Martin (ph). The next question, please.

謝謝你，馬丁（ph）。請下一個問題。

The next question comes from Paul Ligersfeld (ph). Please go ahead, announcing your company name.

下一個問題來自 Paul Ligersfeld（博士）。請繼續宣布您的公司名稱。

Good afternoon. Paul Ligersfeld (ph) of (inaudible). A few questions, please. In connection with a very impressive progress in the U.S., to what extent do you see growth in different segments being that -- the TP (ph) segment versus the (inaudible) segment. And are you gaining share or are you mainly converting own patients?

午安. Paul Ligersfeld（博士）（聽不清楚）。請教幾個問題。關於美國取得的令人印象深刻的進展，您認為不同細分市場的成長程度如何－TP（ph）細分市場與（聽不清楚）細分市場。您是否正在獲得份額，或者主要是在改變自己的患者？

In regard to Japan, now (inaudible) expects to launch (inaudible) at the end of the year in Japan. I don't expect you to go into details for your counter strategy, but can you give a feel for the expected market dynamics and what effect that will have on your sales where I estimate you have sales (inaudible) segment of more than 500 million Danish kroner.

關於日本，現在（聽不清楚）預計今年底在日本推出（聽不清楚）。我不希望您詳細介紹您的反擊策略，但您能否介紹一下預期的市場動態以及這將對您的銷售產生什麼影響，我估計您的銷售（聽不清楚）部分超過 5 億丹麥克朗。

And finally, in connection with NN2211, if you could elaborate a little bit on the trial structure of Phase II (ph) and the expected Phase III (ph). Have you conducted monotherapy studies or studies with (inaudible) and have you in Phase II (ph) had XBA1C (ph) as an end (ph) point and would you expect that to have an end (ph) point in Phase III?

最後，關於 NN2211，您能否詳細說明 II 期 (ph) 和預期的 III 期 (ph) 的試驗結構。您是否進行過單一療法研究或（聽不清楚）研究，並且您在II 期(ph) 階段是否以XBA1C (ph) 作為終點(ph)，您是否期望在III 期中以XBA1C (ph) 作為終點( ph)？

Thank you very month, Paul. This is Lars Rebien. I would like to pose the last question first, actually to Mars Krosgaard, and the 2211 on the (inaudible) trial from Phase II (ph), can you elaborate a little on the design and what you have (inaudible)?

非常感謝你，保羅。我是拉爾斯·雷比恩。我想先向 Mars Krosgaard 以及第二階段 (ph) 的（聽不清楚）試驗中的 2211 提出最後一個問題，您能否詳細說明設計和您擁有的內容（聽不清楚）？

Yes, I can, indeed. And vis-à-vis, the study that we have just announced, this was (inaudible) study, i.e., we wanted to explore the entire (inaudible) and we succeeded in doing so. The first two trials were of 12-weeds duration and they showed that we were able to bring patients into guideline control with lower dose of Lirepatide (ph) but they also did tell us that we were not at the (inaudible) level of dosing. This is why we did the dose (inaudible) trial.

是的，我確實可以。相對於我們剛剛宣布的研究，這是（聽不清楚）研究，即我們想要探索整個（聽不清楚），並且我們成功地做到了這一點。前兩項試驗持續時間為12 種雜草，它們表明我們能夠使用較低劑量的利瑞帕肽(ph) 將患者納入指南控制範圍，但它們也確實告訴我們，我們並未達到（聽不清）劑量水平。這就是我們進行劑量（聽不清楚）試驗的原因。

Now the patients were 144 in different groups, either a monotherapy with Lirepatide or combo with Metformin, against Metformin as mono or Metformin in combo with Amaril (ph). The patients had a baseline HP1C to the tune of 9.5 percent, PMI above 30 and duration was five weeks. We titrated the dose with half milligram dose increments over the five weeks. Actually, this also went for the Amaril (ph) up until the top dose as approved by the European regulators. So it's a multiple dosing regimen and we do expect that the dose to be explored in Phase III (ph) will optimal level of maximum 2 milligrams.

現在，患者有 144 名，分在不同的組別中，要么是利瑞帕肽單藥治療，要么是與二甲雙胍聯合治療，二甲雙胍單藥治療，或者二甲雙胍與 Amaril 聯合治療（ph）。患者的基線 HP1C 為 9.5%，PMI 高於 30，持續時間為五週。我們在五週內以半毫克劑量增量滴定劑量。事實上，Amaril (ph) 也是如此，直到歐洲監管機構批准的最高劑量。因此，這是一個多次給藥方案，我們確實預計 III 期 (ph) 中探索的劑量將達到最大 2 毫克的最佳水平。

(inaudible) the combination therapy, we were quite impressed by the data and I could highlight that even though HP1C is an average of the last three to four months glucose control, we in only five weeks were able to see a more than one percentage point decrement, i.e., improvement in A1C in the Lirepatide (ph) combo group.

（聽不清楚）聯合療法，我們對數據印象深刻，我可以強調，儘管 HP1C 是過去三到四個月血糖控制的平均值，但我們在短短五週內就能夠看到超過一個百分點減少，即Lirepatide (ph) 組合組中A1C 的改善。

So basically, we are very comfortable with test data and it means in totality, we have now studied in animals different combinations of Lirepatide (ph) and other OADs (ph). But in humans, we have primarily looked at add-on (inaudible) on monotherapy as it stands alone.

所以基本上，我們對測試數據非常滿意，這意味著總的來說，我們現在已經在動物身上研究了 Lirepatide (ph) 和其他 OAD (ph) 的不同組合。但在人類中，我們主要關注的是單一療法的附加療法（聽不清楚），因為它是獨立的。

The Phase III (ph) design as such, I am not willing to elaborate in great detail on at this stage because it's in the works. I would though, say that the ICH guidelines for how much you need for (inaudible) therapy such as Type II diabetes namely across 3,000 patients is something that will clearly exceed in the program that we are planning on.

對於第三階段（ph）的設計本身，我不願意在現階段詳細闡述，因為它還在進行中。不過，我想說的是，ICH 指南中關於 3,000 名 II 型糖尿病患者需要多少（聽不清楚）治療的指南顯然會超出我們計劃的計劃。

Also we will explore those different let's say approaches towards combination therapy, both with OADs (ph) and potentially even insulin. But those are things that I think we should discuss at a later point in time.

此外，我們還將探索那些不同的合併治療方法，包括 OAD (ph) 甚至可能是胰島素。但我認為我們應該稍後再討論這些事情。

Thank you, Mars. This is Lars again here. With regards to the United States, we see an overall very satisfactory development of our insulin bases in the U.S. which basically means that we are gaining share in both segments, as you call contract segment or the non-retail segment and the retail segment. This is primarily driven by endocrinologists or specialists that are converting patients to our insulin analogue (inaudible), but also increasing putting Type II patients (inaudible) mix.

謝謝你，火星。我又是拉斯。就美國而言，我們看到我們的胰島素基礎在美國的整體發展非常令人滿意，這基本上意味著我們在兩個細分市場（即合約細分市場或非零售細分市場和零售細分市場）的份額都在增加。這主要是由內分泌學家或專家推動的，他們正在將患者轉用我們的胰島素類似物（聽不清楚），但也增加了 II 型患者（聽不清楚）的組合。

We're also seeing a growth of our business, both in devices and non-device delivered insulin, meaning vials and pens. And it is primarily the growth of our analogues (inaudible) mix which is driving our business in the U.S. The overall growth in market shares, about two market share points over the last 12 months in the United States.

我們也看到我們的業務在設備和非設備輸送胰島素（即小瓶和筆）方面的成長。主要是我們的類似產品（聽不清楚）組合的成長推動了我們在美國的業務。市場佔有率的整體成長，過去 12 個月在美國的市佔率增加了約兩個百分點。

With regards to Japan, it is correct that it has been speculated and anticipated that Avantis (ph) would launch (inaudible) in Japan later this year. However, it is not expected to be the case at this point in time. The Japanese authorities are increasing concerned about the quality of injection devices in the Japanese market. We have suffered from that in the past and have had several dealings with the Japanese authorities on device quality and know the stringent standards that they are applying.

關於日本，猜測和預期 Avantis (ph) 將在今年晚些時候在日本推出（聽不清楚）是正確的。然而，目前預計情況不會是這樣。日本當局越來越關注日本市場注射器材的品質。我們過去曾遭受過這種情況的困擾，並與日本當局就設備品質進行了多次交涉，並了解他們所採用的嚴格標準。

And we believe that as a consequence of this, that it is unlikely that Avantis (ph) will launch (inaudible) this year. Thank you very much. Next question, please?

我們認為，因此，Avantis (ph) 不太可能在今年推出（聽不清楚）。非常感謝。請下一個問題？

The next question comes from Hendrick Seimanson (ph). Please go ahead, announcing your company name.

下一個問題來自 Hendrick Seimanson（博士）。請繼續宣布您的公司名稱。

Hi. Hendrick Seimanson (ph) from (inaudible). A few pipeline questions, if I may. Firstly, what size of trial do you expect to run on NovoSeven and GI bleeds in the second trial? Could you update us on the enrollment in the trauma trial also for NovoSeven? Thirdly, I would like to hear about the AC (ph) study, when we should expect to have data on the ARDS Phase II (ph) study and how enrollment is going there. And then, fourthly, if you could talk a little bit about the size of your U.S. growth hormone franchise. You mentioned that about 65 percent is outside Japan. And fifthly, perhaps, could you tell us if there's been any changes in your U.S. sales force?

你好。亨德里克·塞曼森（Hendrick Seimanson）（博士）來自（聽不清楚）。如果可以的話，有幾個管道問題。首先，您預計在第二次試驗中對 NovoSeven 和胃腸道出血進行多大規模的試驗？您能否向我們介紹 NovoSeven 創傷試驗的註冊情況？第三，我想聽聽有關 AC (ph) 研究的信息，我們何時應該獲得有關 ARDS II 期 (ph) 研究的數據以及該研究的註冊情況。第四，您能談談您在美國的生長激素特許經營權的規模嗎？您提到約 65% 位於日本境外。第五，您能否告訴我們您的美國銷售團隊是否有任何變化？

Thank you very much, Hendrick (ph). This is Lars Rebien here. Mars Krosgaard, you're on again. Several questions -- very high interest in the pipeline development here of NovoSeven, the studies that you intend to undertake on GI bleeds, trauma, how's the enrollment going, (inaudible) when are we going to see data and how's the enrollment going on the ARDS studies. And then we have additional questions on the U.S. HGH franchise and our sales force in the U.S., which I will refer to.

非常感謝你，亨德里克（ph）。我是拉爾斯·雷比恩。馬斯·克羅斯加德，你又來了。有幾個問題——對 NovoSeven 的管道開發非常感興趣，您打算對胃腸道出血、創傷進行研究，招募進展如何，（聽不清楚）我們什麼時候可以看到數據以及招募進展如何ARDS 研究。然後我們還有關於美國 HGH 特許經營權和我們在美國的銷售隊伍的其他問題，我將提到這一點。

OK. Right, Hendrick (ph). I can just briefly mention that the ongoing trials, or rather the one that has been finalized we believe with a good result in the upper GI bleeding, that was 240 patients. Now obviously we came to realize that the subsegments that showed a very good response was the moderate to severe patients, i.e., the so-called (inaudible) BMC (ph). They constitute 75 percent of the total upper GI population of the world, which is around 120,000 people in the industrialized world, i.e., by reducing the signal to noise (ph) ratio, we can, of course, optimize on let's say the (inaudible). But it's too early for me to give you a set number or let's say estimate for the included patients in the trial to come.

好的。對，亨德里克（ph）。我可以簡單提一下正在進行的試驗，或者更確切地說，我們認為已經完成的試驗在上消化道出血方面取得了良好的效果，該試驗涉及 240 名患者。現在顯然我們開始意識到，表現出非常好的反應的亞段是中度至重度患者，即所謂的（聽不清楚）BMC (ph)。他們佔世界上消化道總人口的 75%，在工業化世界中大約有 120,000 人，也就是說，透過降低信噪比 (ph)，我們當然可以優化（聽不清楚） ）。但對我來說，現在給你一個確定的數字或即將到來的試驗中納入的患者的估計還為時過早。

Vis-à-vis the trauma study, this is one that is enrolling a total of 280 patients, approximately 50 percent looking at blunt trauma and 50 percent at pentrating trauma. It's ongoing both in the European and one other continent, or at least one other continent, and it is something that we will report on in the second half of this year as we promised.

就創傷研究而言，這項研究總共招募了 280 名患者，其中約 50% 針對鈍性創傷，50% 針對穿透性創傷。它正在歐洲和另一個大陸，或至少在另一個大陸上進行，我們將按照我們的承諾在今年下半年對此進行報告。

Now again, pro forma, you can see different scenarios. There's kind of scenario where you see absolutely nothing and you don't quite know where to go. This is an area where you see in some segments either blunt or penetrating or certain patients have very good effect. And then you'll decide your trial based on those subsegments of the population. And then there's, of course, the one scenario where you get proof of concept regardless of the fact that the population is heterogeneous and then will have to take it from there in a positive (inaudible) together with the regulator.

現在，再一次，準備考試，你可以看到不同的場景。在這種情況下，你什麼也看不到，你也不知道該去哪裡。這是一個區域，你會看到某些節段要么是鈍的，要么是穿透的，或者某些患者有很好的效果。然後您將根據這些人群來決定您的試驗。當然，還有一種情況是，無論人口是異質的，你都可以獲得概念驗證，然後必須與監管機構一起積極（聽不清楚）地從那裡獲取它。

Vis-à-vis the (inaudible) for the adult respiratory distress or (inaudible) this is something where recruitment is nice. We will be reporting during next year and pending the (inaudible) data that we get, of course either we will take it further or (inaudible) trial program or publish the data, which is quite usual in these circumstances. But recruitment is quite fine.

相對於（聽不清楚）成人呼吸窘迫或（聽不清楚）這是招募很好的事情。我們將在明年進行報告，並等待我們獲得的（聽不清楚）數據，當然我們將進一步採取（聽不清楚）試驗計劃或發布數據，這在這種情況下很常見。不過招募還蠻不錯的。

Thank you very much, Mars. Then to the growth hormone franchise in the United States. It is correct that our underlying franchise in the United States is growing very, very strongly. I would have to say and admit, though, from a very modest level, if you look at the growth hormone business (inaudible) we have two regions which currently are of a similar size. This is the European business and the Japanese business and then we have two other regions which are a similar size, the North American business and international operations. And we also have similar growth rates in international operations and in North America where we have high growth rates in Europe compared to that of Japan. So relatively modest, but of course as the growth rates continue increasing the important business for Novo Nordisk.

非常感謝你，火星。然後是美國的生長激素特許經營權。確實，我們在美國的基礎特許經營業務正在非常非常強勁地成長。不過，我必須說並承認，從一個非常適度的水平來看，如果你看看生長激素業務（聽不清楚），我們有兩個目前規模相似的地區。這是歐洲業務和日本業務，然後我們還有另外兩個規模相似的地區，即北美業務和國際業務。我們在國際業務和北美也有類似的成長率，與日本相比，我們在歐洲的成長率很高。相對溫和，但當然，隨著成長率繼續增加諾和諾德的重要業務。

With regard to the sales force, the only changes that we have undertaken in the sales force is the addition of some additional medical educated individuals to support our (inaudible) business being able to (inaudible) directly with the (inaudible) in the United States while taking upon themselves to (inaudible).

關於銷售隊伍，我們在銷售隊伍中進行的唯一改變是增加了一些受過醫學教育的人員，以支持我們的（聽不清楚）業務能夠（聽不清楚）直接與美國的（聽不清楚）合作同時承擔起自己的責任（聽不清楚）。

So we're still talking about 600 GP reps?

那我們還在談論 600 位 GP 代表嗎？

Around that size is correct.

大約這個尺寸是正確的。

Thank you.

謝謝。

Thank you. Next question, please.

謝謝。請下一個問題。

The next question comes from Rigal Negolit (ph). Please go ahead, announcing your company name.

下一個問題來自 Rigal Negolit (ph)。請繼續宣布您的公司名稱。

Hello.

你好。

Hello.

你好。

Can you hear me?

你聽得到我嗎？

Yes, absolutely.

是的，一點沒錯。

OK. My question is on the gross margin side. It seems that on an underlying basis after currency, it grew by about 0.3 percent over the quarter. And I'm just wondering, there is a growth of high profitability products like NovoSeven and I imagine analogues carry with them a much higher gross margin than straight insulin products. So I'm just wondering, what is the offsetting effect on the cost side that is kind of holding your gross margin back from growing faster?

好的。我的問題是關於毛利率方面的。似乎在扣除貨幣因素後的基本基礎上，該季度增長了約 0.3%。我只是想知道，NovoSeven 等高獲利產品的成長，我認為類似產品的毛利率比直接胰島素產品高得多。所以我只是想知道，成本方面的抵銷效應是什麼，阻礙了您的毛利率更快成長？

Thank you very much. Yes, (inaudible) what is holding back the margins in the first quarter?

非常感謝。是的，（聽不清楚）是什麼阻礙了第一季的利潤率？

Yes, you correctly stated that our reported growth margin dropped by approximately 1.7 percent and that was negatively impacted to the tune of two percentage points from the currency development. The increase is then coming from the NovoSeven and insulin analogues. The full margin effect from insulin analogues will actually come into our accounts during 2003 and 2004 as we roll out our new production facilities. We need to scale up the production that will (inaudible) insulin analogues before we see the full margin effects of those products.

是的，您正確地指出，我們報告的成長率下降了約 1.7%，貨幣發展對這產生了約兩個百分點的負面影響。這種成長主要來自 NovoSeven 和胰島素類似物。當我們推出新的生產設施時，胰島素類似物的全部邊際效應實際上將在 2003 年和 2004 年期間計入我們的帳戶。在看到這些產品的全部利潤效應之前，我們需要擴大（聽不清楚）胰島素類似物的生產規模。

And then I should also remind you that we have had negative growth in the HRT franchise, which is also a reasonably high margin product for Novo Nordisk. So that also impacts the overall portfolio whereas the lower margin product, human insulin and (inaudible) continues to be a significant of (inaudible).

然後我還應該提醒您，我們的 HRT 特許經營權出現了負增長，這對諾和諾德來說也是一個相當高利潤的產品。因此，這也會影響整體投資組合，而利潤率較低的產品、人類胰島素和（聽不清楚）仍然是（聽不清楚）的重要組成部分。

So I think it's all those factors and then the manning of our new facility which are currently being running. All that added to (inaudible) slight breakdown on our margins and you should expect them following those new facilities coming, to be improving (inaudible) onward.

所以我認為這是所有這些因素以及我們目前正在運行的新設施的人員配置。所有這些都增加了（聽不清楚）我們的利潤率略有下降，您應該期望他們在這些新設施到來後，會繼續改善（聽不清楚）。

So for the rest of this year and next year you would expect the underlying gross margin improvement to be somewhat higher than you reported in this quarter?

那麼，在今年剩餘時間和明年，您預計潛在的毛利率改善將略高於本季度報告的水平？

I think it will be very gradual over the next few quarters or so and I think with the current volatility we have in currencies, it would be very, very hard to (inaudible) out from the overall numbers. But a slight improvement (inaudible). You should not expect anything really significant in major percentage points.

我認為在接下來的幾個季度左右，這將是非常漸進的，而且我認為，鑑於當前貨幣的波動性，很難（聽不清楚）從總體數字中得出結論。但略有改善（聽不清楚）。您不應該期望在主要百分點上有任何真正顯著的變化。

OK, thanks.

好，謝謝。

Thank you very much. Next question, please. Hello, next question?

非常感謝。請下一個問題。你好，下一個問題？

The next question comes from Ben Yo (ph). Please go ahead, announcing your company name.

下一個問題來自 Ben Yo (ph)。請繼續宣布您的公司名稱。

Good afternoon. It's Ben Yo (ph) at HSBC. I was just wondering, not withstanding the week Q1 in 2002 which mostly affected diabetes care, but a lot of the sales growth in Q1 '03 seems to exceed the prescription rate utilization. I was wondering as to what extent that sales have been boosted by wholesaler buyer patterns or it is primarily a price increase effect that you've also had there.

午安.我是匯豐銀行的 Ben Yo（博士）。我只是想知道，儘管 2002 年第一季的那一周主要影響了糖尿病護理，但 03 年第一季的許多銷售成長似乎超過了處方率使用率。我想知道批發商買家模式在多大程度上促進了銷售，或者主要是您在那裡也遇到了價格上漲效應。

And my question was I was wondering what order of parallel importing effects are you seeing in your business and what do you think this impact on your business will be this year?

我的問題是，我想知道您在您的業務中看到的平行進口影響的順序是什麼？您認為今年對您的業務的影響是什麼？

Thank you very much. You making a reference to some market data as to whether or not we are seeing changes in stock holding of wholesalers. We had mentioned that our sales of (inaudible) makes (inaudible) in the United States have been influencing it (inaudible) filling in the United States to a relatively modest level. Due to the unfortunate events of the first quarter 2002, we have made an extraordinary effort in terms of looking into wholesaler stocks on an ongoing basis to monitor discrepancies between (inaudible) sales, market consumption which we get from IMA (ph and what remains in the wholesaler inventory. And to the best of our knowledge, we do not see major changes overall in wholesaler stocks in the first quarter. With regard to parallel ...

非常感謝。您提到了一些市場數據，我們是否看到批發商的庫存發生變化。我們曾提到，我們在美國的（聽不清楚）品牌（聽不清楚）的銷售一直在影響美國的（聽不清楚）填充至相對適度的水平。由於2002 年第一季發生的不幸事件，我們在持續調查批發商庫存方面付出了巨大的努力，以監測（聽不清楚）銷售、我們從IMA 獲得的市場消費之間的差異（ph 值和剩餘量）批發商庫存。據我們所知，我們沒有看到第一季批發商庫存總體發生重大變化。關於並行......

Could I just open that to say sort of what levels -- are you talking about an inventory level of maybe now about a month and what value was that modest pipeline filling?

我可以打開它來說明一下什麼水平嗎？您是在談論現在大約一個月的庫存水平嗎？適度的管道填充有什麼價值？

This is Jasper Brandgaard. Maybe I can add a little bit of clarity. To be a little more precise, you could estimate that a bit more than five percent of the growth in the North American insulin sales was impacted by the pipeline filling. And you should expect the North American market will typically be a market where you could see this pipeline filling first (inaudible) reasons when we introduce new products where there will be a pipeline filling. And also you will see wholesale movements in the U.S. as the U.S. continues to be a market where there will (inaudible) price changes from the pharmaceutical producers and that will lead to wholesaler movements.

這是賈斯珀·布蘭德加德。也許我可以補充一點清晰度。更準確地說，您可以估計北美胰島素銷售成長的 5% 以上受到管道填充的影響。您應該預期，當我們推出新產品時，北美市場通常會是一個您可以看到該管道填充的第一個（聽不清楚）原因的市場，其中將有一個管道填充。此外，您還將看到美國的批發變動，因為美國仍然是一個藥品生產商（聽不清楚）價格變化的市場，這將導致批發商的變動。

But a five percent ballpark movement in the growth rate in North America for first quarter as a result of wholesaler movements.

但由於批發商的變動，北美第一季的成長率大約變化了百分之五。

Thank you. And just following up that, is the inventory level in the pipeline at the moment about two weeks to a month or is it a little bit over that?

謝謝。接下來，目前的庫存水準是大約兩周到一個月還是稍微超過這個水準？

Oh, we won't remark on that one specifically. You'll have to call our Investor Relations people after the conference call. They will look more detailed into how much is on inventory of these products. We have to separate these out so it is a little bit tough ...

哦，這個我們就不具體評論了。電話會議結束後，您必須致電我們的投資者關係人員。他們將更詳細地了解這些產品的庫存量。我們必須將它們分開，所以有點困難......

OK, thank you.

好的謝謝。

... on a short-term basis to give you an answer on that. We'll look into it. Please call our Investor Relations people in Copenhagen. With regard to your final question which was parallel trade in Europe, what we do see is we do see an increasing level of parallel trade to the point where it is deducting a (inaudible) one to two percentage points from the top line of our European business. And a consequence of that is also impacting our operating profit from the European business. We must expect that in the short time we'll see continuations of this parallel trade, and maybe an escalation of the parallel trade. Obviously, we have modeled into our financial forecast so that it's included in the forecast that we have been giving you. Eventually, longer term with the introduction of analogue which typically are priced at (inaudible) European price level, with the advent of the euro, all currencies which are (inaudible) this is an issue which will be going away, say three or four years from now. But right now we're suffering from it to some extent in Europe, but it's manageable in the sense that we are modeling it in to our financial forecast.

……短期內給你一個答案。我們會調查一下。請致電我們在哥本哈根的投資者關係人員。關於你的最後一個問題，即歐洲的平行貿易，我們確實看到平行貿易的水平不斷增加，達到了從我們歐洲的頂線扣除（聽不清）一到兩個百分點的程度。商業。其結果也影響了我們歐洲業務的營業利潤。我們必須預料到，在短時間內，我們會看到這種平行貿易的延續，甚至可能是平行貿易的升級。顯然，我們已經對我們的財務預測進行了建模，以便將其包含在我們向您提供的預測中。最終，從長遠來看，隨著通常以（聽不清楚）歐洲價格水平定價的類似貨幣的引入，隨著歐元的出現，所有貨幣（聽不清楚）這個問題將消失，比如說三到四年現在起。但目前歐洲在某種程度上正遭受這種情況的困擾，但從我們正在將其納入財務預測的角度來看，這是可以控制的。

Thank you very much.

非常感謝。

You're welcome. Next question, please.

不客氣。請下一個問題。

The next question comes from Sebastian Berton (ph). Please go ahead, announcing your company name.

下一個問題來自塞巴斯蒂安·伯頓（博士）。請繼續宣布您的公司名稱。

Yes. Hello, gentlemen. Sebastian Berton (ph) from (inaudible). I've got three questions. One is on NovoSeven. Will you include some cirrhotic patients in the second GI bleed trial? And also do you think you'll be ...

是的。先生們好。塞巴斯蒂安·伯頓 (Sebastian Berton)（ph）來自（聽不清楚）。我有三個問題。其中之一是 NovoSeven。您會在第二次胃腸道出血試驗中納入一些肝硬化患者嗎？還有你認為你會...

What patients will we included?

我們將包括哪些患者？

Will you be including cirrhotic patients in the new GI bleeds trial? And also do you intend to liver transplantation also is with cirrhotic patients? Is this the end of your trials in that area? The second question is regarding growth hormone. Is there some stocking effect somewhere outside Japan because the U.S. is certainly a low part of your sales and probably don't explain why you have such high growth rates in Q1 versus the average growth rates you've shown us last year. And last question regarding financial income for '04. Given the lower currency rate right now, what is your new assessment of your hedging gains that you could be able to book in 2004?

您會將肝硬化患者納入新的胃腸道出血試驗嗎？還有肝硬化患者也打算進行肝臟移植嗎？你在那個領域的考驗到此結束了嗎？第二個問題是關於生長激素。日本以外的地方是否存在庫存效應，因為美國肯定佔你們銷售額的一小部分，並且可能無法解釋為什麼你們在第一季度的增長率與去年向我們展示的平均增長率相比如此高。最後一個問題是關於 04 年的財務收入。鑑於目前較低的匯率，您對 2004 年可以預訂的避險收益有何新的評估？

Thank you very much. The first question is for Mars Krosgaard. NovoSeven, are you going to continue work that includes cirrhotic patients (inaudible) undertake on liver transplantation and upper GI bleeds?

非常感謝。第一個問題是問馬爾斯·克羅斯加德的。 NovoSeven，您是否會繼續進行包括肝硬化患者（聽不清楚）在內的肝臟移植和上消化道出血的工作？

Yes. Thank you very much for that question. It's a rather important for me to simply clarify to you what kind of bleeding we're talking about because during my early presentation, I described the difference cutting into a liver that is normal and cutting into a liver that rubber-like because of the cirrhosis. So these two are things where you can compare the bleeding from the organ. What we're speaking about in the cirrhotic patients with upper GI bleeds is a completely different situation where the bleeding is going bleeding (inaudible) in the esophagus because of the so-called portal (ph) hypertension due to the cirrhosis. So this is a completely different so-called high pressure bleed that you cannot compare to the cirrhotic (inaudible) bleed and hence, we will indeed including to severe cirrhotics and these are the ones that are the very good responders in the first Phase II (ph) trial. Vis-à-vis the liver transplantation, also the bleed there is completely different from hepatectomy because what you do is you take out an organ that weight approximately three kilograms, and using forceps you have to simply take out all the vessels -- arteries and veins and what-not -- and make sure that you connect them in the right and orderly way again with a new organ. And there what happens is the bleeding occurs from all those putting vessels together due to the new organ being taken in the body. So that is the bleeding from the major vessels as compared to upper GI where its (inaudible) bleeding from veins around the esophagus as compared to the hepatectomy where its bleeding from the cut surface on the liver, i.e., completely different scenarios. So, yes, the liver transplantation will be severely cirrhotic and the upper GI will be moderate to severely cirrhotic. And if we continue hepatectomy, that will not be in cirrhosis.

是的。非常感謝你提出這個問題。對我來說，簡單地向您澄清我們正在討論的是什麼類型的出血是相當重要的，因為在我的早期演講中，我描述了切入正常肝臟和切入因肝硬化而呈橡膠狀的肝臟的區別。所以這兩個是你可以比較器官出血的地方。我們所說的上消化道出血的肝硬化患者是一種完全不同的情況，由於肝硬化引起的所謂門靜脈高壓，食道出血（聽不清楚）。因此，這是一種完全不同的所謂高壓出血，您無法將其與肝硬化（聽不清楚）出血進行比較，因此，我們確實將嚴重肝硬化納入其中，而這些是在第一個第二階段中反應非常好的患者（ ph) 試驗。對於肝臟移植來說，出血也和肝切除完全不同，因為你要做的就是取出一個重約三公斤的器官，用鑷子簡單地取出所有的血管——動脈和血管。靜脈之類的——並確保用新的器官再次以正確有序的方式連接它們。由於新器官被移入體內，所有將血管放在一起的人都會出血。因此，這是來自主要血管的出血，與上消化道的出血（聽不清楚）是來自食道周圍靜脈的出血相比，肝切除術是來自肝臟切面的出血，即完全不同的情況。所以，是的，肝臟移植會出現嚴重肝硬化，上消化道會出現中度至重度肝硬化。如果我們繼續進行肝切除術，那就不會是肝硬化。

Thank you very much, Mars. With regards to the human growth hormone business, we do not see wholesaler stocking of human growth hormone outside of Japan so it is market growth and it's gain of market share, which is driving our performance both in Europe, United States and international markets as well. All three regions are seeing strong development of market position and as a consequence of that sales. (Inaudible) what are your expectations for (inaudible) gains in 2004? Jasper, hedging -- what are your expectations for hedging gains in 2004?

非常感謝你，火星。關於人類生長激素業務，我們沒有看到日本以外的批發商庫存人類生長激素，因此這是市場成長和市場份額的增加，這也推動了我們在歐洲、美國和國際市場的表現。所有三個地區的市場地位和銷售都取得了強勁的發展。 （聽不清楚）您對 2004 年（聽不清楚）收益有何期望？ Jasper，對沖－您對 2004 年對沖收益的預期是什麼？

We are not currently giving significant guidance on 2004, but let me just get back to what I said on February 5th. At that point in time, we stated that we would expect to record approximately 200 million of financial hedging gain as income in 2004. And given that we've had a slight deterioration in the main currencies, looking at the start (ph) rates compared to February 5, I think you'll be looking at a U.S. dollar down approximately one percent and yen down close to two percent and the pound in the ballpark of four percent down. And from that you can understand in the hedging period that I was describing to you, that I would have slightly more to realize as hedging gain also in 2004. And also a slight increase in hedging periods.

我們目前沒有對 2004 年提供重要指導，但讓我回到 2 月 5 日所說的話。當時，我們表示預計將在 2004 年將約 2 億美元的金融對沖收益記錄為收入。考慮到主要貨幣的匯率略有惡化，請看一下與到2 月5 日，我認為美元將下跌約1% ，日圓將下跌近2%，英鎊將下跌約4%。由此您可以了解到，在我向您描述的對沖期間，我將在 2004 年實現更多的對沖收益。而且對沖期間也略有增加。

Thank you very much, Jasper. Thank you for the question. Could we have one or two more questions, please?

非常感謝你，賈斯柏。感謝你的提問。請問我們還有一兩個問題嗎？

The next question comes from Annette Larsen (ph). Please go ahead, announcing your company name.

下一個問題來自 Annette Larsen（博士）。請繼續宣布您的公司名稱。

Yes, it's Annette Larsen (ph) from Carneige (ph). I have two questions. First of all, on NN2344. You said in nine months or that we would get an update on that on your synthesizer program in the first quarter this year. Can you give us any comment related to that. And, more specific, how have you progressed with the analysis of the long-term animal safety data there? And my second question related to GLP1. I know you have already answered some of it regarding how come it takes longer to get started with Phase III (ph), but how come you didn't clarify the issues during the Phase II (ph) because I anticipate that you already at that time knew that you would continue with this higher dose in Phase III (ph). And could you shed some light on how long-term you think the Phase III (ph) studies will take?

是的，我是卡內基大學的安妮特·拉森（Annette Larsen）（博士）。我有兩個問題。首先，關於NN2344。您說過九個月內，或者我們將在今年第一季獲得有關您的合成器計劃的最新資訊。您能給我們任何相關的評論嗎？更具體地說，您對長期動物安全數據的分析進展如何？我的第二個問題與 GLP1 有關。我知道您已經回答了一些關於為什麼需要更長的時間才能開始第三階段（ph）的問題，但為什麼您沒有澄清第二階段（ph）期間的問題，因為我預計您已經在那個階段了時間知道您將在第三階段(ph) 中繼續使用更高的劑量。您能否透露一下您認為 III 期 (ph) 研究需要多長時間？

Thank you very much. Mars, the first question is one of MM2344 where we have previously communicated that we would see a time lag before we can move on with 2344 and (inaudible) due to the fact that we need to conduct additional animal studies to ensure that we do not have any untowards side effects as we experienced with (inaudible). Where are we on that? When will we see some data of some of the clinical trials, et cetera, on 2344. And finally, on the (inaudible), can you shed a little more light on the manufacturing issues as well as the expectations (inaudible) Phase III (ph) clinical studies?

非常感謝。火星，第一個問題是MM2344 中的一個，我們之前曾表示，在我們繼續進行2344 之前，我們會看到一個時間滯後，並且（聽不清楚），因為我們需要進行額外的動物研究，以確保我們不會有任何我們經歷過的不良副作用（聽不清楚）。我們在這方面的進展如何？我們什麼時候才能看到 2344 年的一些臨床試驗等數據。最後，關於（聽不清楚），您能否進一步說明製造問題以及預期（聽不清楚）第三階段（ ph) 臨床研究？

Yes, Lars. Basically, you almost gave the answer to the first one on 2344 and that really means that what is the issue is as alluded to earlier, that we are having to do 12-month dog studies, among others, i.e., chronic studies of animals to ensure lack of inadequate, or let's say unacceptable toxicity before you can embark on a Phase III (ph) study. Those studies, of course, were only planned followed the (inaudible) that we had Q3 last year. That means that we're still quite some away from being able to update you on a Phase III (ph) (inaudible) that is really contingent upon what we see in those one-year studies. Vis-à-vis Lirepatide, in a way you're right, Annette (ph), that if we could know that (inaudible) was the way to go in Phase III (ph), but we could not do that. What we can say is that now we know that the full dose response curve probably includes two milligrams as a dose in Phase III (ph) trial, and reminding ourselves that 0.75 milligrams was the highest dose selected in the two 12-week studies. This means that we are upping the dose almost effectively at the highest level, i.e., to ensure that the patients get a feel that they have small injections in (inaudible) devices. We basically (inaudible) new formulation and some more (inaudible) substance, and this is why it will take slightly or somewhat longer than we initially communicated.

是的，拉斯。基本上，你幾乎在 2344 上給出了第一個問題的答案，這實際上意味著問題是什麼，正如之前提到的，我們必須進行 12 個月的狗研究等，即對動物進行長期研究在開始III 期(ph) 研究之前，確保沒有不充分的或不可接受的毒性。當然，這些研究只是在去年第三季（聽不清楚）之後才計畫好的。這意味著我們距離能夠向您通報第三階段（ph）（聽不清楚）的最新情況還有很長的路要走，這實際上取決於我們在這些為期一年的研究中看到的情況。對於 Lirepatide，在某種程度上，您是對的，Annette (ph)，如果我們能夠知道（聽不清楚）是第三階段 (ph) 的出路，但我們無法做到這一點。我們可以說的是，現在我們知道完整的劑量反應曲線可能包括 2 毫克作為 III 期 (ph) 試驗中的劑量，並提醒自己 0.75 毫克是兩項為期 12 週的研究中選擇的最高劑量。這意味著我們幾乎有效地在最高水平上增加劑量，即確保患者感覺到他們在（聽不清楚）設備中進行了小劑量注射。我們基本上（聽不清楚）新的配方和更多（聽不清楚）的物質，這就是為什麼它會比我們最初傳達的時間稍微或稍微長一些。

Thank you, Mars. I hope that answers the question that was something about how long to do the Phase III (ph) (inaudible)?

謝謝你，火星。我希望這能回答有關第三階段（ph）需要多長時間（聽不清楚）的問題？

Yes, that's correct. But I still don't understand when started working with this new higher dose, how come you didn't start work on this new formulation because I anticipate that you already knew that you have to make a new formulation.

對，那是正確的。但我仍然不明白什麼時候開始使用這種新的更高劑量，為什麼你沒有開始研究這種新配方，因為我預計你已經知道你必須製作一種新配方。

Yes. First of all, I mean I understand your question, but you have to realize that if it were so, that the plateau level was achieved at 1.25 milligrams, for instance, we could have gone with the original formulation and it's a lot of work to the upscaling (ph) of the manufacturing process, new formulations and so on, and it's something that you do at the point in time when you really anticipate that this will be a real-life situation. That we do know now because we have discovered the full dose response. So actually, we couldn't do it earlier than today where we're actually informing you about the sigmoid (ph) curve or the S-shaped curve. Vis-à-vis the duration of the Phase III (ph), it is so that we will look into all aspects from HB1C to (inaudible). So hence, expect 12-month studies and there will be several of them. So it will be a standard package for a major new Type II drug in terms of (inaudible).

是的。首先，我的意思是我理解你的問題，但你必須意識到，如果是這樣的話，例如，穩定水平達到 1.25 毫克，我們可以採用原來的配方，這需要做很多工作。製造工藝的升級（ph ）、新配方等，這是您在真正預計這將成為現實生活情況時所做的事情。我們現在確實知道這一點，因為我們已經發現了完整的劑量反應。所以實際上，我們不可能比今天更早告訴您 s 型 (ph) 曲線或 S 形曲線。關於第三階段 (ph) 的持續時間，我們將研究從 HB1C 到（聽不清楚）的所有方面。因此，預計為期 12 個月的研究將會有好幾項。因此，就（聽不清楚）而言，它將成為主要新 II 類藥物的標準包裝。

OK, thank you.

好的謝謝。

Thank you so much, miss. Then we'll take a final question, please?

非常感謝你，小姐。那我們將提出最後一個問題，好嗎？

The final question comes from Louise Sabet (ph). Please go ahead, announcing your company name.

最後一個問題來自 Louise Sabet（博士）。請繼續宣布您的公司名稱。

Thank you. Louise Sabet (ph) from Lehman Brothers. Could you just provide us with some guidance to the underlying sales for the full year, given that the first quarter was 24 percent? And secondly, are you able to tell us what percentage of the market by value is now insulin analogues in the U.S. and Europe?

謝謝。來自雷曼兄弟的路易絲·薩貝特（Louise Sabet）（博士）。鑑於第一季為 24%，您能否為我們提供一些有關全年基本銷售額的指引？其次，您能否告訴我們目前美國和歐洲胰島素類似物的市場價值佔多少比例？

And finally, on the GLP1 analogue, can you give us any more information on the percentage of patients which experienced nausea and also that withdrew from the study? There weren't any numbers -- just mentioned there were patients that withdrew owing to side effects. And also on the GLP1 analogue, can you be any clearer now as to when we expect to see some data at a scientific conference?

最後，關於 GLP1 類似物，您能否向我們提供更多有關出現噁心以及退出研究的患者百分比的資訊？沒有任何數字——只是提到有些患者因副作用而退出。還有 GLP1 類似物，您現在能更清楚地知道我們預計何時在科學會議上看到一些數據嗎？

Thank you so much. Jasper, will you deal with the issue of the underlying full year sales that can be expected now given the currency environment and how you see that interrelationship to the guidance that we gave earlier?

太感謝了。 Jasper，您能否處理考慮到貨幣環境而現在可以預期的基本全年銷售問題，以及您如何看待與我們之前給出的指導的相互關係？

Yes, the key information there is that we said on the February 5th guidance that we were expecting the sales growth to be recorded more than five. We speak to this now. At that point in time we said that we had an approximate eight percent currency impact and there will slightly more now, although not fully increased five percent (inaudible). So there you have some indication as to what does it mean local currency sales-wise. And then if you break that down and say, "Where's that going to come from?" also recognizing that we had this very high growth local currency first quarter. But that was, of course, impacted by some of the (inaudible) events related to first quarter last year. The key drivers will be our (inaudible) franchise that we expect to grow in the ballpark of 10 percent, very much in line with our overall guidance of a having a five percent volume growth and a five percent value (inaudible). So (inaudible) we didn't expect to be growing in the 15 percent ball park -- a significant portion of that will be coming from increased use in North America. We are facing a positive probably mid single-digit to high single-digit in our human growth hormone franchise. We are positively encouraged by the performance we've seen in our first quarter. And then finally, on the HRT front there, we will probably expect a slight decline for the full year. The HRT franchise looks challenging with the overall market conditions we've seen since the release of the American health initiatives starting there. So I think that provides you with some guidance on sales.

是的，關鍵訊息是我們在 2 月 5 日的指導中表示，我們預計銷售成長將超過 5。我們現在就談這個。當時我們說我們對貨幣產生了大約 8% 的影響，現在會稍微增加，儘管沒有完全增加 5%（聽不清楚）。因此，您對當地貨幣銷售意味著什麼有了一些了解。然後如果你把它分解並說：“那是從哪裡來的？”也認識到我們第一季的本地貨幣成長非常高。但這當然受到了去年第一季相關的一些（聽不清楚）事件的影響。關鍵的驅動力將是我們的（聽不清楚）特許經營權，我們預計其增長幅度約為10%，這非常符合我們的整體指導，即銷量增長5% 和價值增長5%（聽不清楚） 。因此（聽不清楚）我們預計不會實現 15% 左右的成長——其中很大一部分將來自北美的使用量增加。我們的人類生長激素系列產品正面臨中個位數到高個位數的正成長。我們對第一季的表現感到積極鼓舞。最後，在 HRT 方面，我們可能會預計全年會略有下降。自從美國健康倡議發布以來，我們所看到的整體市場狀況使 HRT 特許經營看起來充滿挑戰。所以我認為這為您提供了一些銷售指導。

Thank you, Jasper. With regard to the share of the insulin market which are constituted by insulin analogues at the moment in the U.S. and in Europe, I can give you the numbers for Europe first and then the United States. In Europe, we see a straight line projection of penetration of insulin analogues that now constitute -- if we take the latest monthly numbers and leaves two (inaudible), it looks like a straight line (inaudible) month-by-month of 28 percent, whereas -- and this is in value -- in volume it is 22 percent. This was in the European analogue penetration. If we take the analogue penetration in the United States, the value here is at 65 percent, whereas the volume is at 34 percent. And again, here is a straight line of projections. We see a continued conversion of (inaudible) human insulin to insulin analogues and, hence, we're expecting that in (inaudible) will be 80 percent of the market will be converted as we thought when we converted from animal insulin to human insulin. And as a consequence, you will see significant value upgrade which is going to look like a price increase, but it is, in fact, a conversion to higher value-added products. And finally, Mars Krosgaard, 2211, the hot topic of the day. Can you shed light to what extent the patients and their enrollment are experiencing the transient nausea, to what extent you've seen withdrawal as a result of this.

謝謝你，賈斯柏。關於目前美國和歐洲由胰島素類似物構成的胰島素市場份額，我可以先給你歐洲的數字，然後是美國的數字。在歐洲，我們看到胰島素類似物滲透率的直線預測——如果我們採用最新的月度數據並留下兩個（聽不清楚），那麼它看起來就像一條直線（聽不清楚）逐月增長28% ，而──這是價值──數量的22%。這是歐洲模擬的滲透率。如果我們以美國的模擬滲透率為例，這裡的數值為 65%，而銷售量為 34%。再說一遍，這是一條直線投影。我們看到（聽不清楚）人類胰島素持續向胰島素類似物轉變，因此，我們預期（聽不清楚）80% 的市場將像我們從動物胰島素轉變為人類胰島素時所設想的那樣轉變。因此，您將看到顯著的價值升級，這看起來像是價格上漲，但實際上是轉向更高附加價值產品的轉變。最後是火星·克羅斯加德，2211，今天的熱門話題。您能否透露一下患者及其入組患者在多大程度上經歷了短暫的噁心，您在多大程度上看到了因此而退出的情況？

Yes. Indeed, each 2211 group, or the Lirepatide group, was comprised of 36 patients, i.e., you had around 72 patients exposed to Lirepatide. We did seen transient nausea as expected and as published previously during the running phase. And being transient of (inaudible), we actually saw only in totality three patients withdrawing due to the nausea side effect -- not vomiting but nausea -- two of them from the mono therapy group and one of them from the combination therapy group between Lirepatide and Metformin. So it's important to stress that besides what you would expect to see, maybe the GI side effect profile, there has been seen no clinical relevant changes or any safety parameters identified for Lirepatide. Which, in a way is not so unexpected because it is, after all, a natural hormone that we have engineered into one (inaudible) administration.

是的。事實上，每個 2211 組或利瑞帕肽組由 36 名患者組成，即大約有 72 名患者暴露於利瑞帕肽。正如預期和之前在運行階段發布的那樣，我們確實看到了短暫的噁心。作為短暫的（聽不清楚），我們實際上總共只看到三名患者因噁心副作用（不是嘔吐而是噁心）退出，其中兩名來自單一治療組，另一名來自利瑞帕肽聯合治療組和二甲雙胍。因此，需要強調的是，除了您期望看到的情況（可能是胃腸道副作用）外，尚未發現利瑞帕肽的臨床相關變化或任何安全參數。這在某種程度上並不那麼令人意外，因為畢竟它是一種天然激素，我們已經將其設計成一次（聽不清楚）給藥。

So the withdrawals were only related to nausea?

那麼戒斷只是與噁心有關？

These three patients, two from the mono group and one from the combo group, were related to nausea, i.e., what you're alluding to as the GI side effect. Yes.

這三名患者，兩名來自單一組，一名來自組合組，與噁心有關，即您提到的胃腸道副作用。是的。

OK. And were there other reasons for withdrawal.

好的。還有其他退出原因嗎？

Yes. Both in the Metformin and Amaril (ph) and GLP1 groups, you had patients drop out because of inadequate glycemic control when, for instance, they discontinue Metformin and so on and so forth.

是的。在二甲雙胍組、Amaril (ph) 組和 GLP1 組中，都有患者因血糖控制不足而退出，例如，他們停用二甲雙胍等等。

OK.

好的。

So the overall dropouts are in the ball park that you always see in Type II diabetes study. So there's nothing particularly interesting there.

因此，整體退出率處於 II 型糖尿病研究中經常看到的大致範圍內。所以那裡沒有什麼特別有趣的地方。

Thank you.

謝謝。

OK. Thank you to all of you. Thank you for listening in. We have been looking forward to get back to you after the summer vacation, hopefully with good results from the first half 2003 (inaudible). Thank you very much.

好的。謝謝大家。感謝您的收聽。我們一直期待著暑假結束後與您聯繫，希望 2003 年上半年能取得好的成績（聽不清楚）。非常感謝。

That concludes today's conference call. You may now disconnect your lines. Good bye.

今天的電話會議到此結束。現在您可以斷開線路。再見。