【中美创新时报2024 年 5 月 3 日编译讯】（记者温友平编译）莫德纳（Moderna ）突破性的 COVID-19 疫苗销量暴跌，引发了华尔街关于这家曾经被视为马萨诸塞州制药领域最耀眼明星的生物技术公司未来的争论。一位公司观察人士表示，股价飙升引发“令人头疼”。《波士顿环球报》记者Jonathan Saltzman 和 Robert Weisman对此作了下述报道。
Moderna 的信使 RNA 疫苗第一季度销量同比下降 91%，这戏剧性地表明，针对导致全球大流行的病毒的保护需求正在减弱。这家剑桥公司周四发布的收益报告显示，该生物技术疫苗 Spikevax 的销量继续呈下降趋势。
尽管如此，Moderna 的股价在纳斯达克交易所上涨了 12.5% 以上，显然是因为收入下降幅度没有许多投资者预期的那么严重。Moderna 唯一上市产品 Spikevax 的销售额从去年的 19 亿美元骤降至 1.67 亿美元。 这实际上超出了分析师 9750 万美元的预测。
波士顿投资银行 Leerink Partners 的分析师马尼·福鲁哈尔 (Mani Foroohar) 表示，怀疑者们认为该股被高估了，并质疑该公司能否通过后续产品取得同样的成功，“这只股票引起了一些怀疑”。
五年前，大多数人几乎不知道 Moderna 在疫情爆发初期就已成为家喻户晓的名字。它与总部位于纽约的制药巨头辉瑞公司展开竞争，希望成为第一家获得美国紧急使用许可的新冠疫苗的制药商。
辉瑞公司以一周的优势赢得了冲刺，并于 2020 年 12 月 11 日获得了批准。尽管如此，Moderna 的疫苗还是一鸣惊人——就像辉瑞公司的疫苗一样——并将这家生物技术公司的几位高管和创始人变成了亿万富翁，其中包括首席执行官斯蒂芬·班塞尔（Stéphane Bancel ）和董事会董事长兼公司联合创始人努巴尔·阿费延（Noubar Afeyan）。
Moderna 已经为其他传染病建立了强大的候选疫苗管道。它们都利用信使 RNA 来刺激免疫反应。在去年的一次采访中，班塞尔预测 Moderna 将在未来十年内成为世界上最大的制药商之一。 “我们不是只会一招的小马，”他说。
尽管新冠疫苗销量大幅下滑，但大多数追踪 Moderna 的人仍持看涨阵营，预计未来产品的巨大需求——包括呼吸道合胞病毒疫苗、新冠疫苗和流感疫苗，以及增强现有疫苗的实验性疫苗 由合作伙伴默克公司开发的癌症治疗方法。
Jefferies 投资银行董事总经理、生物技术分析师迈克尔·易（Michael Yee ）表示：“Moderna 正在投资并为未来推出多种新产品做准备。”他对该公司的股票给予了“买入”评级。“吸收和销售可能有助于再次推动未来增长的更好前景，并实现多元化，摆脱仅限于新冠疫情的影响。”
看跌阵营中的分析师包括莱林克合伙人（Leerink Partners ）的福鲁哈尔（Foroohar），他是少数几家发布“卖出”评级的 Moderna 股票观察家之一，预计该公司将表现不佳。他指出，悬而未决的问题之一是加拿大 Arbutus Biopharma 公司（该公司生产药物输送产品）对 Moderna 提起的专利侵权诉讼的结果。
福鲁哈尔表示：“这种[信使 RNA] 技术在正确的时间出现在正确的地点，而大流行病就是杀手级应用程序。”但他认为，Moderna 要想在紧迫的时间表内重复 Spikevax 所取得的壮举，将是一项挑战。 。
Moderna 并不是唯一一家遭受大流行后收入下降的疫苗制造商。辉瑞周三还报告称，对其新冠病毒产品的需求下降：其竞争对手 mRNA 疫苗 Comirnaty 与德国生物技术公司 BioNTech 一起销售，以及用于治疗这种疾病的抗病毒药物 Paxlovid。
辉瑞表示，预计今年 Comirnaty 和 Paxlovid 的销售额合计将达到 80 亿美元。这些产品的收入到 2023 年将降至 125 亿美元，比 2022 年 570 亿美元的峰值下降 78%。
据公司发言人称，按员工人数计算，Moderna 是马萨诸塞州最大的本土制药商，截至 2023 年年底，该州拥有超过 4,400 名员工。该公司表示，预计美国食品和药物管理局将于本月批准其 RSV 疫苗，以赶上美国秋季的疫苗接种活动。Moderna 还准备很快推出 Spikevax 的更新版本。
班塞尔表示：“当我们预计推出 Spikevax 2024-2025 配方和 RSV 疫苗时，我们正在遵守财务纪律，”包括使用人工智能“进一步简化运营并提高生产力”。
为了削减成本，Moderna 已经解雇了其制造部门的员工。上个月，这家拥有 14 年历史的生物技术公司宣布与人工智能公司 OpenAI 建立合作伙伴关系，以实现其许多操作的自动化。
尽管其新冠疫苗销量大幅下滑，Moderna 报告第一季度净亏损 11.8 亿美元，即每股 3.07 美元，低于预期。相比之下，去年同期的净利润为 7900 万美元，即每股 19 美分。
尽管如此，班塞尔仍预测 Moderna 及其 mRNA 疫苗将迎来出色的一年。该公司有 10 种处于后期临床试验的实验疫苗，包括季节性流感和巨细胞病毒（CMV）疫苗，巨细胞病毒是一种常见病毒，会影响怀孕期间的婴儿并导致出生缺陷。该公司表示，针对 Epstein-Barr 病毒、水痘-带状疱疹病毒和诺如病毒的实验性疫苗也取得了进展。
Moderna 还致力于开发治疗癌症的治疗性疫苗。其中包括与默克公司的肿瘤药物 Keytruda 结合使用的疫苗，用于治疗膀胱癌、肾癌和最常见的皮肤癌之一的患者。
班塞尔表示：“随着 10 个后期项目以及其他新项目向关键研究的推进，我们仍然预计今年将出现众多产品里程碑。”
Moderna 即将完成迁往剑桥新全球总部的工作，该总部位于肯德尔广场宾尼街 325 号，占地 462,000 平方英尺。此前，该生物科技公司总部位于科技广场200号，并占据了附近的几栋建筑。公司计划于6月26日举行新总部盛大开业仪式。
题图：2023 年 6 月，Moderna 员工大卫·罗萨多（David Rosado ）对公司位于诺伍德的生产工厂内的工作站进行了消毒。DAVID L. RYAN/GLOBE STAFF
附原英文报道：
Moderna’s COVID vaccine sales plunge, as analysts debate future of once-hot company
Surging shares elicit “head scratching,” one company watcher says
By Jonathan Saltzman and Robert Weisman Globe Staff,Updated May 2, 2024
Plunging sales of Moderna’s breakthrough COVID-19 vaccine have touched off a Wall Street debate about the future of a biotech company once seen as the brightest star in the Massachusetts drug-making firmament.
Sales of Moderna’s messenger RNA vaccine fell 91 percent in the first quarter from a year earlier, a dramatic illustration of waning demand for protection from the virus that caused a global pandemic. The Cambridge company’s earnings report, posted Thursday, continued a downward trend for sales of the biotech’s vaccine, Spikevax.
Nonetheless, Moderna’s shares surged more than 12.5 percent on the Nasdaq exchange, apparently because the revenue drop wasn’t as sharp as many investors had anticipated. Sales of Spikevax, Moderna’s only marketed product, plummeted to $167 million from $1.9 billion last year. That actually beat analysts’ predictions of $97.5 million.
“The stock is eliciting some head scratching” among skeptics who think the stock is overvalued and question if the company can meet the same success with follow-on products, said Mani Foroohar, an analyst with Boston investment bank Leerink Partners who is among the doubters.
Barely known to most people five years ago, Moderna became a household name early in the pandemic. It raced New York-based pharmaceutical giant Pfizer in the hopes of becoming the first drug maker to get a COVID vaccine cleared for emergency use in the United States.
Pfizer won the sprint by a week, getting its shot cleared on Dec. 11, 2020. Nonetheless, Moderna’s vaccine proved a blockbuster — as did Pfizer’s — and turned several of the biotech’s executives and founders into billionaires, including chief executive Stéphane Bancel and board chairman and company cofounder Noubar Afeyan.
Moderna has built a robust pipeline of vaccine candidates for other infectious diseases. They all harness messenger RNA to stimulate an immune response. In an interview last year, Bancel predicted Moderna would be one of the world’s largest drug makers within the coming decade. “We are not a one-trick pony,” he said.
Even as its COVID vaccine sales tumble, most of those who track Moderna remain in the bullish camp, anticipating huge demand for future products — including a vaccine for respiratory syncytial virus, a combination COVID and influenza vaccine, as well as experimental vaccines to boost existing cancer treatments developed by partner Merck.
“Moderna is investing and preparing for multiple launches of new products ahead,” said biotech analyst Michael Yee, managing director at the Jefferies investment bank, who has issued a “buy” rating on the company’s shares. “Uptake and sales could help drive a better outlook to future growth again and diversify away from just COVID.”
In the bearish camp are analysts such as Foroohar of Leerink Partners, one of a handful of Moderna stock watchers who have issued “sell” ratings, expecting the company will underperform. Among the open questions, he notes, is the outcome of patent infringement litigation against Moderna brought by Canada’s Arbutus Biopharma, which makes a drug delivery product.
“This [messenger RNA] technology was in the right place at the right time, and the pandemic was the killer app,” said Foroohar, but he thinks it will be challenging for Moderna to repeat the feat it achieved with Spikevax on an aggressive timetable.
Moderna isn’t the only vaccine maker suffering from a post-pandemic revenue decline. Pfizer on Wednesday also reported falling demand for its COVID products: its rival mRNA vaccine called Comirnaty that it marketed with the German biotech BioNTech, and the antiviral pill Paxlovid for treating the illness.
Pfizer said it expects $8 billion in combined sales for Comirnaty and Paxlovid this year. Revenue for those products fell to $12.5 billion in 2023, down 78 percent from the peak of $57 billion in 2022.
Moderna is the largest homegrown drug maker in Massachusetts by head count, with more than 4,400 employees in the state of as late 2023, according to a company spokesperson. The firm said it expects the Food and Drug Administration will approve its RSV vaccine this month, in time for the US vaccine campaign in the fall. Moderna is also preparing for the launch of an updated version of Spikevax soon.
“As we anticipate the launches of our Spikevax 2024-2025 formula and RSV vaccine, we are exercising financial discipline,” including using artificial intelligence to “further streamline operations and enhance productivity,” said Bancel.
Moderna has laid off employees within its manufacturing unit as it seeks to cut costs. Last month the 14-year-old biotech announced a partnership with artificial intelligence company OpenAI to automate many of its operations.
Despite plunging sales of its COVID vaccine, Moderna reported a smaller-than-expected net loss of $1.18 billion, or $3.07 per share, for the first quarter. That compares with net income of $79 million, or 19 cents per share, reported for the same period a year ago.
Bancel nonetheless predicted an excellent year for Moderna and its mRNA vaccines. The company has 10 experimental vaccines in late-stage clinical trials, including shots for seasonal flu and cytomegalovirus, or CMV, a common virus that can affect babies during pregnancy and cause birth defects. The firm said it has also made progress with experimental vaccines against Epstein-Barr virus, Varicella-Zoster virus, and norovirus.
Moderna is also working on therapeutic vaccines to treat cancer. They include vaccines that would be combined with Merck’s oncology drug Keytruda to treat patients with bladder cancer, kidney cancer, and one of the most common forms of skin cancer.
“With 10 late-stage programs, and additional new programs advancing toward pivotal studies, we continue to expect numerous product milestones this year,” Bancel said.
Moderna is nearing completion of its move to a new global headquarters in Cambridge, a 462,000-square-foot complex at 325 Binney St. in Kendall Square. Previously, the biotech was based at 200 Technology Square and occupied a few buildings nearby. The company is planning a grand opening of the new headquarters on June 26.
