Is Pfizer's China slowdown the ‘canary in the coalmine?’
Big Pharma has been able to count on China to jack up growth for the last several years, but in the second quarter one drugmaker—Pfizer's Upjohn unit—wasn't so fortunate.
Is that an ill omen for the rest of multinational pharma? One analyst is posing the question.
During the second quarter, Pfizer’s Upjohn established medicine business—now destined to merge with Mylan—plummeted 20% in China, mainly because of a volume-based procurement system under testing in 11 major Chinese cities.
The program rolled out in March, and Upjohn’s Q2 plunge dragged the New York pharma’s overall China sales growth to a mere 2%, a huge decline from the 20%-plus increases it's posted over the previous three quarters at least, Wolfe Research analyst Tim Anderson noted in a recent report to clients.
Is this the “canary in the coalmine?” he asked; after all, almost all companies have an “Upjohn” of their own.
Yes and no. It's true the so-called “4+7“ program, which centers on off-patent drugs, is a dual-threat: It offers up a big proportion of public hospitals’ prescriptions to the winning bidder in exchange for price cuts.
And Pfizer suffered on both counts. About 40% of Upjohn's Chinese business came from the 11 cities participating in the procurement pilot, Upjohn President Michael Goettler said during a July conference call about the Mylan marriage.
Two of its top sellers in emerging markets, cardiovascular therapies Lipitor and Norvasc, were hit hard after they lost the contracts to local generic makers. Lipitor’s ex-U.S. sales dropped 23% year-over-year to $377 million in Q2, according to a Pfizer quarterly filing.
And the problem wasn't just limited to losing a major chunk of business. As the low winning prices came out last December, drugmakers had to slash prices beyond those tenders to stay in the game. By the time the pilot program launched in mid-March, Pfizer had already reported pricing pressure on those meds in its Q1 securities filing.
RELATED: Pfizer's big split is finally here, thanks to a giant generics merger with Mylan
But Pfizer’s Q2 suffering looks like an outlier compared with its peers. AstraZeneca, which lost the Crestor tender but won the Iressa race, saw its Q2 China sales jump a whopping 44% at constant currencies, to $1.17 billion. Sanofi, whose heart drugs Plavix and Aprovel also lost in the bulk purchase scheme, enjoyed Q2 China sales growth of 17%, to €709 million ($787 million).
What did AstraZeneca and Sanofi have on their side? As Wolfe’s Anderson pointed out, mature products are not all created equally.
For example, AZ’s injectables (such as breast cancer drug Faslodex) and respiratory inhalers (such as Pulmicort) are hard to copy and therefore less likely than its other legacy meds to be included in any future procurement programs, Leon Wong, AstraZeneca's EVP in charge of China and the emerging markets, said on a conference call in July.
“Therefore, each company’s near-term growth prospects will be a function not only of its mix of on- and off-patent drugs but also the mix within off-patent drugs,” Anderson wrote in his note.
The stress is on “near-term,” probably into 2020. China has recently been preparing to expand the procurement project, with bidding results expected in October. According to local reports of a Thursday meeting the procurement office had with drugmakers, the extension will just cover the 25 drugs in the current “4+7” pilot; for six of the 31 drugs originally targeted, negotiations failed after the government couldn’t reach a price-cut deal with the manufacturers.
The difference is that this time, more cities across the country will join. The message from officials is clear: Don’t even think of bidding if you don’t offer prices below the “4+7” marks.
RELATED: Copycats wanted: Pfizer, AZ and more under threat as China solicits generics
Sanofi's already forecasting slower growth for the rest of 2019. While its blood thinner Plavix and hypertension med Aprovel both held their own in Q2, they'll slip in China later this year, Sanofi CEO Olivier Brandicourt told investors on the Q2 earnings call in July.
AstraZeneca's Wong also warned the company will not enjoy the same level of growth it has in the past—even more so as it faces National Drug Reimbursement List applications for its SGLT2 diabetes med Farxiga and PARP inhibitor Lynparza.
Such national insurance coverage talks have traditionally led to huge price cuts and, in turn, pressured near-term growth. But managed well, the expanded patient reach can translate into big sales leaps instead, as Roche has seen with its trio of cancer blockbusters. And despite those headwinds, AZ still expects its overall China business will grow at double-digit rates.
Anderson also predicted that Big Pharma’s situation in China won’t be a long-term negative, now that “innovative products are being reimbursed better in China.”
RELATED: China's driving sales growth ahead of the U.S. for Big Pharma. But can it last?
Focusing on new drugs over under-threat legacy brands is the direction almost all multinational pharmas are heading. Sanofi aims to submit more than 10 new products for approval by the end of 2020, Brandicourt said. Pfizer’s remaining biopharma business—without Upjohn—grew at 26% in Q2 and it'll file up to 19 new products in the next few years in China, CEO Albert Bourla has said.
That number for Novartis, which previously lost the Gleevec tender, is 50 by 2023, CEO Vas Narasimhan has said.
Upjohn will soon no longer be Pfizer’s problem and other Big Pharma firms have made similar disposals. Eli Lilly has offloaded some antibiotics brands and a manufacturing facility to Eddingpharm. GSK recently penned a deal to unload its Suzhou factory and rights to its older antiviral drug lamivudine to Fosun Pharma.
Meanwhile, Upjohn, AZ and Sanofi have all decided to target regions outside of China's metropolises for growth. “We see strong potential in China’s counties where we have a dedicated sales force that we can leverage to drive sales outside of these cities,” Brandicourt said during the Q2 conference call.
大型制药公司在过去的几年里一直可以依靠中国来加速增长,但是在第二季度,有一家制药公司——辉瑞公司的 Upjohn 部门——却没有那么幸运。这对其他跨国制药公司来说是个不祥之兆吗?一位分析师提出了这个问题。在第二季度,辉瑞的 Upjohn 建立了医药业务——现在注定要与 Mylan 合并——在中国暴跌 20%,主要是因为在中国 11 个大城市正在测试的基于数量的采购系统。像这样的免费每日通讯?订阅 FiercePharma!生物制药是一个快速增长的世界,每天都有大的想法出现。我们的订户依靠 FiercePharma 作为最新的新闻、分析和数据的必读来源,以及制药公司。今天注册,以获得医药新闻和更新交付到您的收件箱和阅读的走。Wolfe Research 分析师 Tim Anderson 在最近给客户的一份报告中指出,现在就认购项目在 3 月份推出,Upjohn 的 Q2 暴跌拖累了 New York pharma 在中国的整体销售增长仅有 2%,与前三个季度超过 20% 的增幅相比,至少大幅下降。这是“煤矿里的金丝雀吗?”他问。毕竟,几乎所有的公司都有自己的“Upjohn”。是和否。诚然,以专利外药品为中心的所谓“4 + 7”计划是一种双重威胁:它向中标企业提供了很大比例的公立医院处方,以换取降价。而辉瑞在这两个方面都受到了影响。Upjohn 总裁 Michael Goettler 在 7 月关于 Mylan 婚姻的电话会议上说,约 40% 的 Upjohn 中国业务来自参加采购试点的 11 个城市。该公司在新兴市场的两大销售商——心血管治疗药物立普妥 (Lipitor) 和络活喜 (Norvasc)——在失去与当地仿制药制造商的合同后,遭受重创。立普妥的前美国。根据辉瑞季度档案显示,第二季度销售额同比下降 23% 至 3.77 亿美元。问题不仅仅是失去了大部分业务。随着低中标价格在去年 12 月出现,制药商不得不在那些招标之外大幅降价,以留在游戏中。到 3 月中旬试点项目启动时,辉瑞已经在其 Q1 证券备案文件中报告了这些药物的定价压力。相关:辉瑞的大分拆终于来到了这里,多亏了与迈兰的巨型仿制药合并,但与同行相比,辉瑞的 Q2 遭遇似乎是一个离群点。失去 Crestor 竞标资格但在易瑞沙竞赛中胜出的阿斯利康,其在中国 Q2 市场的销售额以固定汇率大幅增长 44%,至 11.7 亿美元。赛诺菲的心脏药物波立维 (Plavix) 和安博维 (Aprovel) 也在批量采购计划中失利,该公司在中国 Q2 的销售额增长了 17%,达到 7.09 亿欧元(7.87 亿美元)。阿斯利康和赛诺菲的立场是什么?正如 Wolfe 的 Anderson 所指出的,成熟的产品并不都是同样创造出来的。例如,阿斯利康负责中国和新兴市场的执行副总裁 Leon Wong 在 7 月的电话会议上表示,AZ 的注射剂(如乳腺癌药物 Faslodex)和呼吸吸入剂(如普米克)很难仿制,因此比其他遗留药物更不可能被纳入任何未来的采购项目。Anderson 在他的报告中写道:“因此,每家公司的短期增长前景将不仅是其在研和非专利药物组合的函数,而且也是非专利药物内的组合。”压力可能会持续到“近期”2020 年。中国最近一直在准备扩大采购项目,预计 10 月份会有招标结果。据当地报道,采购办公室周四与制药商举行了一次会议,延期将仅涵盖目前“4 + 7”试点的 25 个药品。在最初针对的 31 种药品中,有 6 种在政府未能与生产商达成降价协议后谈判失败。不同的是,这一次,全国将有更多城市加入。来自官员的信息是明确的:如果你不提供低于“4 + 7”的价格,甚至没有想到竞标。相关:仿制品需求:辉瑞,亚利桑那州和更多的威胁,因为中国征询仿制药赛诺菲已经在 2019 年剩余时间增长放缓的预测。赛诺菲 CEO Olivier Brandicourt 在 7 月份的 Q2 业绩电话会议上告诉投资者,虽然其血液稀释剂 Plavix 和高血压药物 Aprovel 在 Q2 都保持了各自的优势,但今年晚些时候它们将在中国打折扣。AstraZeneca 的 Wong 还警告说,该公司将不会享有过去那样的增长水平——尤其是面临其 SGLT2 糖尿病药物 med Farxiga 和 PARP 抑制剂 Lynparza 的国家药物报销目录申请。这种全国保险覆盖谈判传统上导致了大幅降价,进而对近期增长造成了压力。但如果管理得好,扩大的患者范围反而可以转化为巨大的销售飞跃,就像罗氏在其三部癌症重磅炸弹中看到的那样。尽管有这些不利因素,AZ 仍然预计其整体中国业务将以两位数的速度增长。安德森还预测,大药厂在中国的情况不会是长期的负面,现在“创新产品在中国报销的更好。“相关因素:中国销量增长领先于美国。对于大型制药公司。但它能持续吗?关注新药而不是受到威胁的传统品牌是几乎所有跨国制药公司的发展方向。Brandicourt 表示,赛诺菲的目标是在 2020 年底前提交超过 10 个新产品申请批准。辉瑞剩余的生物制药业务——没有 Upjohn——在第二季度增长了 26%,未来几年将在中国上市 19 种新产品,CEO Albert Bourla 说。诺华公司的 CEO Vas Narasimhan 说,到 2023 年,这个数字是 50。Upjohn 很快将不再是辉瑞的问题,其他大型制药公司也做出了类似的处置。礼来公司已将一些抗生素品牌和一家生产工厂出售给 Eddingpharm。GSK 最近签署了一项协议,将其苏州工厂及其较老的抗病毒药物拉米夫定的使用权出售给复星医药。与此同时,Upjohn、AZ 和赛诺菲都决定将中国大都市以外的地区作为增长目标。Brandicourt 在 Q2 电话会议上表示:“我们在中国各县看到了强大的潜力,在这些地区,我们拥有一支专门的销售队伍,可以利用他们推动这些城市以外的销售。”
扫码实时看更多精彩文章
