Sawai揭露的Upsher-Smith資訊摘要

以下取自Sawai 20231110公布的財報

保瑞於20240116公布花2.1億鎂從日本澤井製藥集團手中併購Upsher-Smith，澤井在20231110公布的上半年財報（2024.4-2024.9 ）經營成果裡面對於Upsher-Smith的經營成果報告如下，看來不是很樂觀。

(ii) U.S. Business Segment
(ii) 美國業務部門

We entered the U.S. market by acquiring Upsher-Smith Laboratories, LLC (USL) in May 2017. START 2024, the current medium-term plan, envisions that Sawai will make “business investments for future growth in the U.S.” with the growth drivers of “contribution to sales by promoting sales of existing brand drugs and generics,” “further expansion of the product lineup mainly in niche generics,” and “strengthening of product pipelines with high complexity and the product lineup in cooperation with Sawai Pharmaceutical.” To accelerate our growth strategy in the U.S. Business segment, we will work closely with Sumitomo Corporation of the Americas, a U.S.-based Sumitomo Corporation subsidiary that owns a 20% share in USL.
我們於2017年5月通過收購Upsher-Smith Laboratories, LLC (USL)進入美國市場。目前的中期計劃START 2024預計薩威將在美國進行“為未來增長進行商業投資”，增長動力包括“通過推廣現有品牌藥物和仿製藥的銷售貢獻銷售額”，“主要在利基仿製藥領域進一步擴大產品陣容”，以及“與薩威製藥合作，加強高複雜度產品管道和產品陣容”。為了加快我們在美國業務板塊的增長策略，我們將與美國住友商事的子公司Sumitomo Corporation of the Americas密切合作，後者擁有USL 20%的股份。

In the U.S. generic drug market, however, generic drug prices have consistently declined. This is thought to have resulted from three major purchasing groups holding an approximately 90% market share through the formation of alliances amongst wholesalers and pharmacies, and also from the high number of approvals given by the U.S. Food and Drug Administration (FDA) for Abbreviated New Drug Applications (ANDA). USL is still in a challenging business environment with increasing competition in the generic market, as seen by the market entry of generic alternatives to Qudexy®, our core branded product.
然而，在美國的仿製藥市場上，仿製藥價格一直在持續下降。這被認為是由於三個主要的採購團體通過批發商和藥店之間的聯盟組成，佔據了約90%的市場份額，以及美國食品和藥物管理局（FDA）對簡化新藥申請（ANDA）的批准數量很高。USL在仿製藥市場上仍面臨著日益激烈的競爭，這可以從仿製替代品進入市場，取代我們的核心品牌產品Qudexy®來看出。

Under such circumstances, we are taking various measures to achieve stable profitability, including measures to stabilize revenueof existing products and to reduce R&D and other costs.
在這種情況下，我們正在採取各種措施來實現穩定的盈利能力，包括穩定現有產品的收入和減少研發和其他成本的措施。

In April 2023, USL launched Fluphenazine Hydrochloride Tablets, which prevent psychotic disorders, and Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, which is used to lower increased intraocular pressure in glaucoma or ocular hypertension patients who need supplementary therapy for less controllable intraocular pressure.
2023年4月，USL推出了氟哌啶酮盐酸盐片，用于预防精神病性障碍，以及布里莫尼定酒石酸盐和噻吗洛尔酒石酸盐眼用溶液，用于降低青光眼或眼压增高患者的眼内压力，需要辅助治疗以控制眼内压力。

The same year, the company also launched Dicyclomine Hydrochloride Capsules, a treatment for functional or irritable bowel syndrome, in May and other new products in August, including Vigadrone Tablets for infantile spasms and refractory complex partial seizures (CPS), Famotidine for Oral Suspension effective mainly for active duodenal or gastric ulcers, and Mesalamine Extended-Release Capsules for ulcerative colitis. Moreover, USL transferred its manufacturing and selling rights for two acute-phase migraine treatments—Tosymra® Nasal Spray 10 mg (sumatriptan nasal spray) and Zembrace® SymTouch ® 3mg (sumatriptan injection)—and related assets to Tonix Medicines, Inc., a 100% owned subsidiary of Tonix Pharmaceuticals Holding Corp in June 2023.
同年，該公司於五月份推出了治療功能性或過敏性腸道綜合症的Dicyclomine Hydrochloride Capsules，並於八月份推出了其他新產品，包括用於嬰兒痙攣和難治性部分性癲癇（CPS）的Vigadrone Tablets，主要對活躍性十二指腸潰瘍或胃潰瘍有效的Famotidine for Oral Suspension，以及用於潰瘍性結腸炎的Mesalamine Extended-Release Capsules。此外，USL於2023年6月將兩種急性期偏頭痛治療藥物—Tosymra® Nasal Spray 10 mg（舒馬曲普坦鼻腔噴霧劑）和Zembrace® SymTouch® 3mg（舒馬曲普坦注射劑）—以及相關資產轉讓給Tonix Medicines, Inc.，該公司是Tonix Pharmaceuticals Holding Corp的全資子公司。

In terms of production, since January 2023, a new factory at USL headquarters site has been engaged in commercial production to replace the USL factory in Denver, Colorado, which ended its operations in December 2022. This new factory will successively broaden the lineup of products it manufactures, as part of USL’s initiatives to further enhance both product quality and production efficiency and ensure stable product supply.
就生產方面而言，自2023年1月起，USL總部的一個新工廠已開始商業生產，以取代位於科羅拉多州丹佛的USL工廠，該工廠於2022年12月停止運營。這個新工廠將逐步擴大其生產產品的產品線，作為USL進一步提升產品質量和生產效率，確保穩定的產品供應的一部分措施。

As a result, the segment reported net sales of JPY 19,395 million (an increase of 1.7% year on year) and a loss of JPY 210 million (segment profit of JPY 519 million in the same period of the previous year).
因此，該部門報告了淨銷售額為19,395百萬日元（年增1.7%），損失為2.1億日元（去年同期該部門獲利為5.19億日元）。

以下取自Sawai 20240117 的出售子公司公告

The Reason for the Transfer of These Shares 

這些股份轉讓的原因

In 2017, Sawai Group acquired Upsher-Smith with the goal of full-scale entry into the U.S. market, the world’s largest generic drug market. Since this acquisition, we have sought business growth by implementing a variety of measures, including the consolidation/closure of factories, enhancing production capability, and increasing the pipeline capacity.

2017年，薩威集團收購了Upsher-Smith，目的是全面進入全球最大的仿製藥市場─美國市場。自從這次收購以來，我們通過實施各種措施，包括整合/關閉工廠、提升生產能力和增加產品線容量，來尋求業務增長。

 Despite our dedicated efforts, the business environment became increasingly complex as the top three purchasing groups strengthened their buying capabilities and competitors, particularly from India, intensified price competition. Consequently, in the fiscal year ending March 2022, we recorded significant impairments of goodwill and other assets. To address these challenges, we undertook proactive measures such as streamlining back-office operations, implementing cost-cutting initiatives, and restructuring our R&D framework and development strategies. 

儘管我們不遺餘力地努力，但由於前三大採購集團增強了其購買能力，競爭對手，尤其是來自印度的競爭對手，加劇了價格競爭，使得商業環境變得越來越複雜。因此，在截至2022年3月的財政年度中，我們記錄了重大的商譽和其他資產減損。為應對這些挑戰，我們採取了積極的措施，如精簡後勤運營、實施削減成本的舉措，以及重組研發框架和發展策略。

Given these circumstances, Sawai Group discussed various options with its co-investor, Sumitomo Corporation Group. From the discussion, it was recognized that bold product investment strategies and additional investments to effectively utilize Upsher-Smith’s new factory will be needed to stay ahead of its competitors. On the other hand, Sawai Group needs to prioritize the investment of management resources in the Japanese business to solve quality issues and expand demand in Japan. Therefore, Sawai Group decided that the best option would be to sell the shares and interest of the U.S. business to Bora, a globally recognized CDMO with a global commercialization arm who is eager to invest in the U.S. pharma business and effectively utilize Upsher-Smith’s new factory capacity, and concluded an agreement regarding the transfer of these shares.

鑑於這些情況，薩維集團與其合作投資者住友商事集團進行了各種討論。從討論中，我們認識到為了在競爭對手之前保持領先地位，需要大膽的產品投資策略和額外的投資，以有效利用Upsher-Smith的新工廠。另一方面，薩維集團需要將管理資源的投資優先考慮放在解決日本市場的品質問題和擴大需求上。因此，薩維集團決定最好的選擇是將美國業務的股份和利益出售給全球知名的CDMO公司Bora，該公司擁有全球商業化部門，渴望投資美國藥品業務並有效利用Upsher-Smith的新工廠能力。並就這些股份的轉讓達成了協議。