Novo Nordisk Is on the Upswing -- for Now


2019-02-06 14:30:34 YAHOO!FINANCE


After a relatively lackluster first three quarters of 2018, Novo Nordisk capped off the year on the upswing. But the revenue growth doesn't appear to be sustainable, with management guiding for slower growth in the year ahead. Metric Q4 2018 Q4 2017 Year-Over-Year Change Revenue 29.7 billion DKK 28 billion DKK 6.2% Income from operations 10.8 billion DKK 10 billion DKK 7.3% Earnings per share 3.53 DKK 3.36 DKK 5.1% Data source: Novo Nordisk. $1 = 6.54 Danish kroner (DKK) as of Feb. 5. Mads Krogsgaard Thomsen, Novo Nordisk's chief science officer, highlighted plans for getting the oral version of Ozempic (semaglutide) approved in different regions, including a fast-paced program for an approval in the U.S.: Novo Nordisk has notified the FDA that we will ask for a priority review for oral semaglutide based on the priority review voucher acquired in 2018. The use of the priority review voucher shortens the expected FDA review period to six months. We now expect to file the [new drug application] for oral semaglutide with the FDA by the end of this quarter, and in the EU and Japan in the second and third quarters of this year, respectively.  CEO Lars Fruergaard Jorgensen talked about how rebates may go away, but it'll take awhile since they involve multiple players, such as prescription benefit managers (PBMs) and insurance companies: "When we talk about changes in how rebates are handled in the U.S., it's not something we see will have an impact on how business is conducted in 2019, maybe not even in '20 because there are a number of contracts being made between us and our customers, and again from PBMs to insurance companies, etc. So it's a relative comprehensive set of legal commitments and change flow of money that has to be [unwound]." Management is looking for sales growth in the 2% to 5% range when measured in local currencies. Part of the slower growth compared with the fourth quarter will come from a negative impact of approximately 2 billion DKK as Novo Nordisk is responsible for additional funding of the Medicare Part D coverage gap in the U.S. in 2019. Management also warned of continued pricing pressure, especially in the U.S. On the bottom line, operating profit growth is expected to be in the 2% to 6% range when measured in local currencies.
在2018年前三个季度表现相对平淡之后,诺和诺德(Novo Nordisk)在这一年的增长上达到了顶峰。但收入增长似乎并不是可持续的,管理层预计未来一年增长将放缓。 米制 2018年第四季度 2017年第四季度 同比变动 收入 297亿丹麦克朗 280亿丹麦克朗 6.2% 营业收入 108亿丹麦克朗 100亿丹麦克朗 7.3% 每股收益 3.53丹麦克朗 3.36丹麦克朗 5.1% 数据来源:诺和诺德(Novo Nordisk)。1美元=6.54丹麦克朗(丹麦克朗),截至2月5日。 诺和诺德(Novo Nordisk)首席科学官 Mads Krogsgaard Thomsen 强调了在不同地区获得 Ozemic ( semaglutide )口服版批准的计划,包括在美国进行快速审批程序: 诺和诺德(Novo Nordisk)已通知 FDA ,我们将根据2018年获得的优先审评凭证要求对口服 semaglutide 进行优先审评。优先审评凭证的使用将预期的 FDA 审评周期缩短为6个月。我们现在希望在本季度末,以及在今年第二和第三季度分别在欧盟和日本向 FDA 提交口服 semaglutide 的[新药申请]。 首席执行官 Lars Fruegaard Jorgensen 谈到了回扣可能会如何消失,但这需要一段时间,因为它们涉及多个参与者,例如处方福利经理( PBM )和保险公司:“当我们谈论美国如何处理回扣的变化时,我们看到的不会对2019年的业务运营产生影响。”可能在20年内甚至不会,因为我们和客户之间签订了许多合同,从 PBM 到保险公司等。因此,这是一套相对全面的法律承诺和资金流动必须[解除]。” 以当地货币计算,管理层正在寻求2%至5%范围内的销售增长。与第四季度相比,增长放缓的一部分将来自约20亿丹麦克朗的负面影响,因为诺和诺德(Novo Nordisk)将在2019年为美国 Medicare Part D 保险缺口提供额外资金。管理层还警告称,价格压力仍在继续,尤其是在美国。 从底线上看,以当地货币衡量,营业利润增长预计在2%至6%之间。