Cycle Pharmaceuticals Ltd.

近日，Vanda Pharmaceuticals再次拒绝了Cycle Pharmaceuticals收购要约。相比第一次，Cycle的报价不变，仍然是每股8美元，总计合计4.88亿美元。 2024年6月，Cycle首次对Vanda 提出了收购邀约，当时公司股价还上涨了24%。 在Cycle这两次报价中，发生的一件重大事件就是Vanda的胃轻瘫药物tradipitant的新药上市申请遭到FDA拒绝批准。 tradipitant被拒后，Vanda并没有因此觉得自己掉价了，仍然坚持认为Cycle第二次提出的报价严重低估了公司的价值，不符合公司及其股东的最佳利益。Vanda甚至还将Cycle的收购邀约描述为“投机主义”，试图以折让的价格收购公司股票。 在被Vanda拒绝的邀邀约收购的名单上，并非只有Cycle一家。 在此之前（2024年5月），Vanda董事会还拒绝了CDMO公司Future Pak提出的每股7.25—7.75美元的收购邀约。董事会认为，Future Pak的收购会给公司带来巨大的风险和不确定性，不符合股东的最佳利益。为了避免公司被恶意收购，Vanda还因此启动了一项“毒丸计划”。 多次硬刚FDA 如果要描述Vanda的一个突出特点的话，那就是“刚”。 一般的药企在新药上市申请遭到监管拒绝后，都是老老实实补充相关数据，以达到FDA的监管要求，但大多数情况下，这家公司在遇到与FDA意见分歧的时候都选择了硬刚。 早在2018年，FDA部分暂停了tradipitant的两项临床研究后，Vanda就将FDA告上法庭。因为FDA要求Vanda提供动物的临床前毒理数据，而Vanda认为动物研究并非必要的（之后提交新药上市申请的时候，Vanda还是坚持己见，选择了基于微生理系统的非动物临床前毒理学数据，不难理解，FDA最终向公司发出了一封CRL）。 同年，FDA拒绝批准Hetlioz治疗时差障碍的新适应症后，Vanda再度选择与FDA当庭对峙。 这次，tradipitant治疗胃轻瘫的上市申请被拒后，Vanda也同样对FDA的批准决定进行了指责。相关阅读：药物被拒，反而指责FDA违宪 营收下滑挑战 不论是Future Pak，还是Cycle，对Vanda都是提出的溢价收购——目前Vanda的股价为4.8美元/股。 对于Vanda而言，需要应对的是营收出现显著下滑的情况，2023年公司营收较2022年（约2.544亿美元）下降了约24%，为1.926亿美元。 公司收入主要来自两款上市产品Hetlioz和Fanapt。 Hetlioz是一款褪黑素受体激动剂，2014年获得FDA批准用以治疗非24小时睡醒周期障碍，此后又被批准用于治疗史密斯-马吉利综合征。 作为公司的一大营收支柱，Hetlioz贡献了超一半的收入。然而Hetlioz在2023年销售业绩出现显著下滑，同比2022年（1.597亿美元）下降了37%，至1.002亿美元。2024年上半年销售额同样较2023年上半年下降了37%，至3880万美元。 除了销售下滑之外，Hetlioz今年也是流年不利，3月的时候，用于失眠适应症的新药补充上市申请遭到了FDA的拒绝，在4月，Hetlioz还输掉了与仿制药厂家的诉讼，未来Hetlioz想要扭转销售下跌势头将更具挑战。 Fanapt算是有个好消息，今年在4月成功获批了I型双相情感障碍的新适应症批准。Fanapt在2009年首次获得FDA批准，用于急性成人精神分裂症。今年上半年，Fanapt已经成为公司销售额第一的的产品，不过相比2023年（4700万美元），销售额还是下滑了7%，为4370万美元。 事实上，Vanda应该也是对这种情况有所预料，在去年底，Vanda花了1亿美元从强生那收购了一款自免新药Ponvory的美国以及加拿大权益。2024年上半年，Ponvory贡献了1540万美元的销售收入。 参考出处 https://www.fiercepharma.com/pharma/vanda-swats-down-another-buyout-bid-cycle https://www.biospace.com/business/vanda-rejects-another-acquisition-offer-from-cycle-affirms-confidence-in-business药品上市被拒，Vanda再次破防

In Monday's deal, Vanda Pharmaceutical Inc categorically rejected a second takeover proposal from Britain's Cycle Pharmaceuticals that valued the company at $8 per share. Vanda Pharmaceutical is sticking to its position despite a significant drop in its stock price following the US Food and Drug Administration's (FDA) refusal to approve its drug for a stomach ailment. In a formal statement, Vanda Pharmaceutical pointed out that Cycle Pharma's proposed acquisition terms are economically identical to the previous proposal that was evaluated and rejected by Vanda Pharmaceutical. This means that Cycle Pharma's latest offer did not convince Vanda Pharmaceutical's board. Cycle Pharma's $8 per share offer represents an 80% premium to Vanda Pharmaceutical's most recent closing price, valuing the company at $488 million. However, Vanda Pharmaceutical's Board of Directors believes that this valuation significantly undervalues the true value of the Company and is not in the best interests of the Company and its shareholders. Earlier, the FDA refused to approve Vanda Pharmaceutical's stomach disease drug, and the news sent shares of Vanda Pharmaceutical down 4.5%. In June, Vanda Pharmaceutical had already rejected Cycle Pharma's initial offer, as well as a revised offer from contract manufacturer Future Pak. To reduce the risk of a hostile takeover, Vanda Pharmaceutical adopted a shareholder rights plan, commonly known as a "poison pill," in April. Vanda Pharmaceutical has three approved products: Hetlioz for sleep disorders, Fanapt for bipolar I disorder and Ponvory for multiple sclerosis. After carefully reviewing Cycle Pharma's second proposal, Vanda Pharmaceutical's Board of Directors unanimously concluded that the proposal did not adequately reflect the value of Vanda Pharmaceutical and decided not to pursue the proposal. In a statement, Cycle Pharma said it remains willing to work with Vanda Pharmaceutical's board of directors and management team to reach an agreement that provides a compelling premium and some cash value to all of Vanda Pharmaceutical's shareholders. After Vanda Pharmaceutical rejected the takeover proposal, its shares rose 11.37 percent to $4.95 per share in trading on Monday. This increase in the share price reflects the market's positive reaction to Vanda Pharmaceutical's rejection of the acquisition proposal, as well as confidence in the company's future prospects.

iStock, Atstock Productions Cycle’s second unsuccessful takeover bid comes on the heels of the FDA denying approval for Vanda’s tradipitant, which was being proposed for the treatment of gastroparesis. Vanda Pharmaceuticals on Monday announced that it has rejected a second unsolicited and non-binding takeover proposal from Cycle Pharmaceuticals. The proposed buyout price of $8.00 per share “substantially undervalues Vanda and is not in the best interests of the company and its stockholders,” according to Monday’s announcement. Vanda’s board of directors called the latest takeover attempt from Cycle an “opportunistic attempt to purchase the company’s shares at a discount to Vanda’s intrinsic value.” Vanda’s leadership said it remains “confident” in the company’s growth—driven by a strong cash position and efficient operations—which puts the biopharma in a good position to deliver long-term value “far in excess” of Cycle’s offer. There is no action required for stockholders at this time, according to the announcement. Cycle in its press release on the offer encouraged Vanda shareholders to express their support for the proposal, insisting that the $8.00-per-share price tag “represents [an] 80% premium to Vanda’s share price at the close of business on October 11, 2024.” At this purchase price, Cycle’s offer amounted to a fully diluted equity value of $488 million. Cycle’s latest takeover bid, which it filed on Sept. 23, comes just days after the FDA rejected Vanda’s drug application for the investigational NK-1R antagonist tradipitant, which it was proposing for the treatment of gastroparesis. While some analysts have called the rejection “unsurprising”—given a failed Phase III trial and amid unaddressed prior concerns from the FDA—Vanda has continued to strongly stand by its drug candidate, even going so far as to challenge the regulator’s verdict. The biopharma blasted what it called the “delayed” verdict of the FDA, claiming the regulator “fails to satisfy the requirements specified by the Food Drug and Cosmetic Act (FDCA).” Despite the rejection, Vanda will continue to seek approval for tradipitant and sustain its expanded access program. Cycle previously attempted to acquire Vanda in June 2024, for which it similarly offered $8.00 per share. At the time, the proposal reflected a 63% premium to Vanda’s closing price on May 23, 2024, the day before the offer was submitted. Vanda was also locked in a regulatory row with the FDA when it received Cylce’s first offer—this time over its oral drug Hetlioz (tasimelteon), which the agency rejected for the treatment of insomnia. As in the case of tradipitant, Vanda slammed the FDA’s rejection insisting that it was late in releasing its verdict in violation of the FDCA.