Cumberland Pharmaceuticals Inc (CPIX) 2022 Q4 法說會逐字稿

Good afternoon, and welcome to Cumberland Pharmaceuticals' 2022 Financial Report and Company Update. This call is being recorded at Cumberland's request and will be archived on the company's website for 1 year from today's date. I would now like to turn it over to Molly Aggas, account supervisor at the Dalton Agency, who handles Cumberland's communications. Molly, please go ahead.

下午好，歡迎來到 Cumberland Pharmaceuticals 的 2022 年財務報告和公司更新。此次通話是應 Cumberland 的要求進行錄音的，並將在公司網站上存檔，自今天起保存 1 年。我現在想把它交給 Dalton Agency 的客戶主管 Molly Aggas，她負責處理 Cumberland 的通訊。莫莉，請繼續。

Hello, everyone, and good afternoon. Thanks for joining today's call. Cumberland has issued a press release announcing the company's annual financial results as well as an operational update for the year ending December 31, 2022. The release, which includes the related financial tables, can be found on Cumberland's website at www.cumberlandpharma.com.

大家好，下午好。感謝您參加今天的電話會議。 Cumberland 已發布新聞稿，宣佈公司年度財務業績以及截至2022年12月31日止年度的運營更新。該新聞稿包括相關財務表格，可在 Cumberland 網站 www.cumberlandpharma.com 上找到。

Company management will share an overview of those financial results during today's call. They'll also provide an overall company update, including a discussion of its brands, pipeline and partners.

公司管理層將在今天的電話會議上分享這些財務業績的概覽。他們還將提供公司的整體更新，包括對其品牌、渠道和合作夥伴的討論。

Participating in today's call are A.J. Kazimi, Cumberland's Chief Executive Officer; Todd Anthony, Vice President, Organizational Development; and John Hamm, Chief Financial Officer.

參加今天電話會議的有 A.J. Cumberland 首席執行官 Kazimi； Todd Anthony，組織發展副總裁；首席財務官 John Hamm。

Please keep in mind that their discussions may include forward-looking statements as defined in the Private Securities Reform Act of 1995. These statements reflect the company's current views and expectations concerning future events and may involve risks and uncertainties. Additionally, there are many factors that could affect Cumberland's future results, including natural disasters, economic downturns, public health epidemics, international conflicts and others that are beyond the company's control. Those issues are described under the caption Risk Factors in Cumberland's Form 10-K and any additional updates filed with the SEC. Any forward-looking statements made during today's call are qualified by those risk factors. Despite the company's best efforts, actual results may differ materially from expectations. The information shared on this call should be considered current as of today only. Please remember that the company isn't responsible for updating any forward-looking statements, whether as a result of new information or due to future developments.

請記住，他們的討論可能包括 1995 年私人證券改革法案中定義的前瞻性陳述。這些陳述反映了公司當前對未來事件的看法和預期，可能涉及風險和不確定性。此外，還有許多因素可能影響坎伯蘭的未來業績，包括自然災害、經濟衰退、公共衛生流行病、國際衝突和其他公司無法控制的因素。這些問題在 Cumberland 的 10-K 表格的風險因素標題下以及向 SEC 提交的任何其他更新中進行了描述。在今天的電話會議中所做的任何前瞻性陳述都受到這些風險因素的限制。儘管公司盡了最大努力，但實際結果可能與預期存在重大差異。本次電話會議上分享的信息應視為截至今天的最新信息。請記住，公司不負責更新任何前瞻性陳述，無論是由於新信息還是由於未來發展。

During today's call, there will be references to several of Cumberland's marketed brands. Full prescribing and safety information for each brand is included on the individual product website. And a link to those sites can be found on the corporate website at www.cumberlandpharma.com.

在今天的電話會議中，將提及 Cumberland 的幾個營銷品牌。每個品牌的完整處方和安全信息包含在各個產品網站上。可以在公司網站 www.cumberlandpharma.com 上找到這些網站的鏈接。

The company will also provide some non-GAAP financial measures with respect to performance. An explanation and reconciliation to GAAP measures can be found in the financial tables in the earnings release that was issued earlier this afternoon. If you have any questions, please hold them until the end of the call. At which point, we'll be happy to answer them.

公司還將提供一些與業績相關的非 GAAP 財務指標。在今天下午早些時候發布的收益報告中的財務表格中可以找到對 GAAP 措施的解釋和調節。如果您有任何問題，請等到通話結束。屆時，我們將很樂意回答他們。

With that overview, I'll turn the call over to Cumberland's Chief Executive Officer, A.J. Kazimi.

有了這個概述，我將把電話轉給 Cumberland 的首席執行官 A.J.卡齊米。

Thank you, Molly, and good afternoon, everyone. We appreciate you joining us as we recap another successful year here at Cumberland. During today's call, we'll provide an update on our 2022 operational and financial results while also commenting on our plans. So let's begin.

謝謝你，莫莉，大家下午好。我們感謝您加入我們，因為我們在坎伯蘭回顧了又一個成功的一年。在今天的電話會議中，我們將提供 2022 年運營和財務業績的最新情況，同時也會對我們的計劃發表評論。讓我們開始吧。

First of all, I'm pleased to report that Cumberland delivered significant revenue growth last year despite continuing external challenges. As 2022 progressed, we welcomed the return to a more typical operating environment following the economic and societal effects of the pandemic. We were excited to see enrollment in our clinical trials resume, patient procedures return to more customary levels and access for our sales reps improve as they gain more face-to-face meetings with medical professionals.

首先，我很高興地報告，儘管外部挑戰持續存在，但坎伯蘭郡去年實現了顯著的收入增長。隨著 2022 年的到來，我們歡迎在大流行的經濟和社會影響之後恢復到更典型的運營環境。我們很高興看到我們的臨床試驗恢復註冊，患者程序恢復到更習慣的水平，並且我們的銷售代表的訪問權限隨著他們與醫療專業人員的更多面對面會面而得到改善。

While the impact of the pandemic on the company did subside, some industry challenges persisted. Hospitals faced continued staffing shortages, which had a direct impact on patient care. And in addition, the overall economic downturn has led to financial pressures and uncertainty across the health care industry.

雖然大流行對公司的影響確實消退，但一些行業挑戰仍然存在。醫院面臨持續的人員短缺，這對患者護理產生了直接影響。此外，整體經濟低迷導致整個醫療保健行業面臨財務壓力和不確定性。

Well, despite those challenges, our diversified portfolio of FDA-approved brands enabled us to achieve strong year-over-year revenue growth. And that growth was led by contributions from our newest brand, Sancuso, which we acquired early last year from the U.S. affiliate of Japan-based Kyowa Kirin.

那麼，儘管存在這些挑戰，我們獲得 FDA 批准的品牌的多元化組合使我們實現了強勁的同比收入增長。這一增長得益於我們最新品牌 Sancuso 的貢獻，該品牌是我們去年初從總部位於日本的 Kyowa Kirin 的美國子公司收購的。

Sancuso is a unique oncology support transdermal system that has a well-established base of physicians who prescribe it to help cancer patients tolerate certain side effects associated with their chemotherapy treatments. To help fund the acquisition, we utilized our credit facility, which has $20 million in capital available through a 3-year term.

Sancuso 是一種獨特的腫瘤學支持透皮系統，擁有完善的醫生基礎，他們開出處方以幫助癌症患者耐受與化療相關的某些副作用。為了幫助為收購提供資金，我們利用了我們的信貸額度，該額度在 3 年期限內擁有 2000 萬美元的可用資本。

Turning to our 2022 financial performance. Our product portfolio delivered combined revenues of $42 million, a 17% increase over the prior year. And Sancuso was a significant driver in this growth, quickly proving to be a valuable addition to our product line.

轉向我們 2022 年的財務業績。我們的產品組合帶來的總收入為 4200 萬美元，比上一年增長 17%。 Sancuso 是這一增長的重要推動力，很快證明是對我們產品線的寶貴補充。

Kristalose and Caldolor continued their steady contributions to the revenue mix, while sales of Vibativ underperformed our expectations. However, it is important to note that both Vibativ and Sancuso continue to deliver attractive returns on the investment associated with their acquisition. Our gross margins remained attractive in 2022, resulting in a favorable EBITDA and a total of $8.5 million in cash generated from operations for the year.

Kristalose 和 Caldolor 繼續對收入組合做出穩定貢獻，而 Vibativ 的銷售額低於我們的預期。然而，值得注意的是，Vibativ 和 Sancuso 繼續為其收購相關的投資帶來可觀的回報。我們的毛利率在 2022 年仍然具有吸引力，從而實現了良好的 EBITDA 和全年運營產生的現金總額 850 萬美元。

Our balance sheet remains strong as we ended 2022 with $93 million in total assets, $20 million in cash, $57 million in liabilities and $36 million in shareholders' equity. Towards the end of the year, we successfully moved into our new headquarter offices on the broad West Campus near Vanderbilt University in Nashville. This new state-of-the-art facility will enable us to accommodate our growth, support our team and better serve our patients, customers and partners.

截至 2022 年底，我們的資產負債表依然強勁，總資產為 9300 萬美元，現金為 2000 萬美元，負債為 5700 萬美元，股東權益為 3600 萬美元。年底，我們成功搬進了位於納什維爾范德比爾特大學附近寬闊的西校區的新總部辦公室。這個新的最先進的設施將使我們能夠適應我們的成長，支持我們的團隊並更好地為我們的患者、客戶和合作夥伴服務。

So with that overview of our 2022 results. I'd now like to turn it over to Todd Anthony, Cumberland's Vice President, Organizational Development, to further discuss our brands and our team. Todd?

因此，有了我們 2022 年結果的概述。我現在想把它交給 Cumberland 的組織發展副總裁 Todd Anthony 來進一步討論我們的品牌和我們的團隊。托德？

Thank you, A.J. At Cumberland, we recognize that our people are among our most important assets. Throughout the pandemic, we kept our offices open and business operating while taking measures to provide our team with a safe working environment. During 2022, we successfully completed the transition of responsibilities for Sancuso to Cumberland from Kyowa Kirin. We have now taken full commercial responsibility for the brand in the United States including its national distribution, marketing, promotion and medical support activities.

謝謝你，A.J.在坎伯蘭，我們認識到我們的員工是我們最重要的資產之一。在整個大流行期間，我們保持辦公室開放和業務運營，同時採取措施為我們的團隊提供安全的工作環境。在 2022 年期間，我們成功完成了將 Sancuso 的職責從 Kyowa Kirin 轉移到 Cumberland。我們現在已經對該品牌在美國承擔全部商業責任，包括其全國分銷、營銷、推廣和醫療支持活動。

Late last year, we were very pleased to learn that the move of the product manufacturer to a new facility was approved by the FDA. To support Sancuso, we formed a new sales division, Cumberland Oncology. It's comprised of both field-based and inside sales personnel, most of whom moved over to Cumberland from Kyowa Kirin and bring extensive experience in promoting the brand.

去年年底，我們非常高興地得知產品製造商遷往新工廠的舉措獲得了 FDA 的批准。為了支持 Sancuso，我們成立了一個新的銷售部門 Cumberland Oncology。它由現場銷售人員和內部銷售人員組成，其中大部分人是從 Kyowa Kirin 搬到 Cumberland 並帶來了品牌推廣方面的豐富經驗。

I'd also like to provide a few updates on some of our other brands. First, I'll touch on Vibativ, our potent injectable antibiotic product designed to treat certain serious bacterial infections, including hospital-acquired or ventilator-associated pneumonias as well as complicated skin infections. We are working to improve Vibativ's sales performance in 2023. To achieve that goal, we have taken a fresh look at the marketing and sales strategy and launched a series of new initiatives to increase awareness and use of this important, potentially life-saving brand.

我還想提供一些關於我們其他一些品牌的更新。首先，我將介紹 Vibativ，這是我們的強效注射用抗生素產品，旨在治療某些嚴重的細菌感染，包括醫院獲得性肺炎或呼吸機相關性肺炎以及復雜的皮膚感染。我們正在努力提高 Vibativ 在 2023 年的銷售業績。為實現這一目標，我們重新審視了營銷和銷售戰略，並推出了一系列新舉措，以提高人們對這個重要的、可能拯救生命的品牌的認識和使用。

Moving next to Kristalose, our prescription strength laxative, which continues to be our largest selling product. Packaged in a convenient premeasured powder dose, it dissolves quickly in just 4 ounces of water for a clear, taste-free and grit-free solution. During 2022, we continue to support Kristalose through our field sales force as well as our partnerships with Poly Pharmaceuticals and Foxland Pharmaceuticals. We also refreshed Kristalose's award-winning marketing campaign in 2022 to facilitate increased engagement with our customers and expand patient support for the brand. As a result, it was added to the GoodRx platform.

接下來是我們的處方強瀉藥 Kristalose，它仍然是我們最暢銷的產品。採用方便的預先計量的粉末包裝，僅需 4 盎司的水即可快速溶解，形成清澈、無味且無砂礫的溶液。在 2022 年期間，我們將繼續通過我們的現場銷售人員以及我們與 Poly Pharmaceuticals 和 Foxland Pharmaceuticals 的合作夥伴關係來支持 Kristalose。我們還在 2022 年更新了 Kristalose 屢獲殊榮的營銷活動，以促進與客戶的更多互動並擴大患者對品牌的支持。因此，它被添加到 GoodRx 平台。

Turning now to Caldolor. We continue to feature expanded labeling for its use prior to surgery when we see the best results in significantly reducing patients' pain and their need for opioids. During 2022, we continue to provide Caldolor in a vial and the newer ready-to-use premixed bag presentation. Caldolor has been a steady performer with an international contribution as well. Meanwhile, during 2022, we worked closely with our FDA-approved manufacturers, monitoring our supply chain, including the raw materials as well as the finished goods emerging from those facilities.

現在轉向卡爾多洛。當我們看到顯著減少患者疼痛和阿片類藥物需求的最佳結果時，我們將繼續在手術前使用擴大標籤。在 2022 年期間，我們將繼續提供小瓶裝 Caldolor 和更新的即用型預混袋展示。 Caldolor 一直表現穩定，在國際上也有貢獻。與此同時，在 2022 年期間，我們與 FDA 批准的製造商密切合作，監控我們的供應鏈，包括原材料以及從這些設施中產生的成品。

As we've reported previously, the packager for Omeclamox-Pak brand suspended their operations during the pandemic due to supply issues. The facility is now under new ownership and new management, and we're currently awaiting availability of their operations. We're also exploring other alternatives to restart the product's packaging.

正如我們之前報導的那樣，由於供應問題，Omeclamox-Pak 品牌的包裝商在大流行期間暫停了運營。該設施現在擁有新的所有權和新的管理權，我們目前正在等待他們的運營可用性。我們還在探索其他替代方案來重新開始產品的包裝。

Additionally, we're transitioning to a new manufacturer for our Vaprisol product. We have found a new facility and await the FDA approval of the plant before resuming shipments. Before we can do so, our new manufacturing partner is working with the FDA to address several Form 483 and warning letter issues in a timely manner. Meanwhile, we are working with them to support a special interim supply of compounded product for critically ill patients.

此外，我們正在過渡到 Vaprisol 產品的新製造商。我們已經找到了一個新設施，並等待 FDA 對該工廠的批准，然後再恢復發貨。在我們這樣做之前，我們的新製造合作夥伴正在與 FDA 合作，及時解決幾個 483 表格和警告信問題。同時，我們正在與他們合作，支持為重症患者提供特殊的複合產品臨時供應。

We support our portfolio of FDA-approved medicines through 3 national sales divisions, including our newest Cumberland Oncology. Our hospital sales division calls on key institutional accounts across the country, and our field sales division covers select office-based physicians. We understand the importance of recognizing and addressing our impact on the environment, our employees and the community. On that front, we are pleased to announce that we have updated our sustainability metrics covering company activities pertaining to environmental, social and governance issues. Highlights from our latest sustainability metrics include providing 2.2 million doses of our products to patients, safely disposing of over 2,750 pounds of expired and damaged products and having no product recalls or terminated clinical trials due to failure to practice good clinical standards.

我們通過 3 個國家銷售部門支持我們 FDA 批准的藥物組合，包括我們最新的 Cumberland Oncology。我們的醫院銷售部門拜訪了全國的主要機構客戶，我們的現場銷售部門覆蓋了精選的辦公室醫生。我們了解認識並解決我們對環境、員工和社區的影響的重要性。在這方面，我們很高興地宣布，我們已經更新了可持續發展指標，涵蓋與環境、社會和治理問題有關的公司活動。我們最新的可持續發展指標的亮點包括向患者提供 220 萬劑我們的產品，安全處置超過 2,750 磅的過期和損壞產品，並且沒有產品召回或因未能遵守良好的臨床標準而終止臨床試驗。

Lastly, toward the end of 2022, we successfully moved into our new headquarter offices on the Broad West Campus in the Vanderbilt West End corridor of Nashville. We are delighted to continue our presence and participation in the Nashville health care community, which represents the largest concentration of health care companies in the United States. Our new headquarters also keeps us close to Vanderbilt Medical Center, where we continue our collaboration to develop innovative new medicines.

最後，到 2022 年底，我們成功搬進了位於納什維爾范德比爾特西區走廊 Broad West Campus 的新總部辦公室。我們很高興繼續參與納什維爾醫療保健社區，該社區是美國最大的醫療保健公司集中地。我們的新總部也讓我們靠近范德比爾特醫療中心，我們在那裡繼續合作開發創新藥物。

As that completes my update for today, I'll turn it back to you, A.J.

當我完成今天的更新時，我會把它還給你，A.J.

Very good. Thank you, Todd. Well, before we review our 2022 financial results, I'd like to provide an update on our international and partnering activities. Caldolor, our nonnarcotic pain relief product continues to enjoy significant market share in the South Korean market. In addition, during 2022, we announced a new agreement with PiSA Pharmaceuticals for the registration and commercialization of Caldolor in Mexico. Under the terms of that agreement, Cumberland will be responsible for providing the product dossier and supplies and PiSA will be responsible for securing regulatory approval for the product in Mexico and then introducing it into that market.

非常好。謝謝你，托德。好吧，在我們回顧 2022 年的財務業績之前，我想介紹一下我們的國際和合作活動的最新情況。我們的非麻醉性鎮痛產品 Caldolor 繼續在韓國市場佔有重要的市場份額。此外，在 2022 年期間，我們宣布與 PiSA Pharmaceuticals 就 Caldolor 在墨西哥的註冊和商業化達成新協議。根據該協議的條款，Cumberland 將負責提供產品檔案和用品，而 PiSA 將負責確保該產品在墨西哥獲得監管批准，然後將其引入該市場。

We believe Caldolor can serve an important role in the careful management of pain there, and we're pleased to be working with PiSA and hope to establish a successful partnership. Last year, we also transitioned our distribution for Caldolor in Australia from CSL Seqirus to Phebra Pty Ltd.

我們相信 Caldolor 可以在那裡的疼痛管理中發揮重要作用，我們很高興與 PiSA 合作，並希望建立成功的合作夥伴關係。去年，我們還將 Caldolor 在澳大利亞的分銷從 CSL Seqirus 轉移到 Phebra Pty Ltd。

Turning next to Vibativ, our potent injectable antibiotic. In March of 2022, we announced the launch of Vibativ in Puerto Rico. That announcement followed an agreement with Verity Pharmaceuticals providing them with the rights and responsibilities to introduce the product for patients into that market. Later in March of last year, we announced a new partnership for -- with Saudi Arabia based Tabuk Pharmaceuticals to introduce Vibativ into the Middle East. The arrangements provide Tabuk exclusive rights to distribute Vibativ in Saudi Arabia and Jordan with an option to expand into other countries in the region. Tabuk is a fully owned subsidiary of the Astra Industrial Group, a leading publicly traded conglomerate in Saudi Arabia.

接下來是我們強效的可注射抗生素 Vibativ。 2022 年 3 月，我們宣佈在波多黎各推出 Vibativ。該公告是在與 Verity Pharmaceuticals 達成協議後作出的，該協議賦予他們將患者產品引入該市場的權利和責任。去年 3 月晚些時候，我們宣布與總部位於沙特阿拉伯的 Tabuk Pharmaceuticals 建立新的合作夥伴關係，將 Vibativ 引入中東。這些安排為 Tabuk 提供了在沙特阿拉伯和約旦分銷 Vibativ 的獨家權利，並可以選擇擴展到該地區的其他國家。 Tabuk 是 Astra Industrial Group 的全資子公司，Astra Industrial Group 是沙特阿拉伯領先的上市企業集團。

While Vibativ is now approved for sale in that country, we've added the needed new manufacturing information to the registration and look forward to next launching the project there.

雖然 Vibativ 現在已獲准在該國銷售，但我們已將所需的新製造信息添加到註冊中，並期待下次在那裡啟動該項目。

Also in 2022, we entered into an agreement with D.B. Pharm to register and commercialize our Vibativ product in South Korea. After working with them to prepare the submission for registering the brand there, we now await the approval and look forward to the launch of Vibativ in that country. Meanwhile, our Vibativ partner for the Chinese market, SciClone Pharmaceuticals, had their approval application in China accepted for review back in September of 2021, and we've since been supporting SciClone and the requests associated with the review of that submission. They're working towards the approval and believe there's a significant potential for Vibativ in their country.

同樣在 2022 年，我們與 D.B. 達成了一項協議。 Pharm 在韓國註冊和商業化我們的 Vibativ 產品。在與他們合作準備在那裡註冊品牌的申請後，我們現在等待批准並期待在該國推出 Vibativ。與此同時，我們在中國市場的 Vibativ 合作夥伴 SciClone Pharmaceuticals 於 2021 年 9 月在中國的批准申請被接受審查，此後我們一直支持 SciClone 以及與該提交審查相關的請求。他們正在努力獲得批准，並相信 Vibativ 在他們的國家具有巨大的潛力。

As we focus our efforts on the U.S., we are excited to continue building a network of other established companies to bring Vibativ and Caldolor to patients in their countries.

當我們將精力集中在美國時，我們很高興能繼續與其他知名公司建立網絡，將 Vibativ 和 Caldolor 帶給他們國家的患者。

Meanwhile, our RediTrex product line of prefilled syringes was designed to provide an innovative delivery of methotrexate for the treatment of arthritis. Following the FDA approval, we launched the product into the U.S. market during the pandemic and unfortunately faced difficulties in accessing a new group of office-based physicians and also in quickly securing the needed insurance coverage. However, during 2022, prescriptions for the RediTrex line did grow steadily but not to a level justifying our continued investment in the brand. The FDA fees alone were nearing $2 million annually. So we reengaged Nordic Pharma, who previously provided us with a license for the U.S. rights to the line, and we agreed on amending our arrangements, whereby Nordic would assume responsibility for RediTrex in the United States after June 30 of this year.

同時，我們的 RediTrex 預充式註射器產品系列旨在為治療關節炎提供創新的甲氨蝶呤給藥方式。在獲得 FDA 批准後，我們在大流行期間將該產品推向了美國市場，不幸的是，我們在接觸新的辦公室醫生以及快速獲得所需保險方面遇到了困難。然而，在 2022 年期間，RediTrex 系列的處方藥確實穩步增長，但並未達到我們繼續對該品牌進行投資的水平。每年僅 FDA 的費用就接近 200 萬美元。因此，我們重新聘請了 Nordic Pharma，後者之前為我們提供了美國對該生產線的權利許可，我們同意修改我們的安排，據此 Nordic 將在今年 6 月 30 日之後承擔 RediTrex 在美國的責任。

As a result, we've transferred the RediTrex marketing authorization to Nordic who, in turn, has provided us back the 180,000 shares that we previously issued to them and refunded the $1 million milestone payment that we previously provided. Nordic has also issued a credit note for $1 million and provided approximately $900,000 to reimburse us for FDA fees. We appreciate Nordic's cooperation on these changes as we continue to distribute RediTrex until the end of June and then support Nordic on the product transition.

因此，我們已將 RediTrex 營銷授權轉讓給 Nordic，後者又向我們返還了我們之前發行給他們的 180,000 股股票，並退還了我們之前提供的 100 萬美元里程碑付款。 Nordic 還簽發了 100 萬美元的信用票據，並提供了大約 900,000 美元來償還我們的 FDA 費用。我們感謝 Nordic 在這些變化方面的合作，因為我們將繼續分發 RediTrex 直到 6 月底，然後在產品過渡方面支持 Nordic。

So in addition to our expanding international activities in 2022, we continue to advance an innovative pipeline of new product candidates to address unmet medical needs. As many of you who have been following us know, we're sponsoring 3 Phase II clinical programs featuring our ifetroban product candidates. And these studies involve patients with aspirin-exacerbated respiratory disease or AERD, a severe form of asthma, and systemic sclerosis a debilitating autoimmune disorder, and Duchenne muscular dystrophy, a genetic neuromuscular disease. This third program is being funded by a $1 million grant provided from the FDA's Office of orphan drug products.

因此，除了我們在 2022 年擴大國際活動之外，我們還將繼續推進新候選產品的創新管道，以滿足未滿足的醫療需求。許多關注我們的人都知道，我們正在讚助 3 個以我們的 ifetroban 候選產品為特色的 II 期臨床項目。這些研究涉及患有阿司匹林加重的呼吸系統疾病或 AERD（一種嚴重的哮喘）、系統性硬化症（一種使人衰弱的自身免疫性疾病）和杜氏肌營養不良症（一種遺傳性神經肌肉疾病）的患者。第三個項目由 FDA 孤兒藥產品辦公室提供的 100 萬美元贈款資助。

It's the first study Duchenne muscular dystrophy awarded an FDA orphan product development funding grant. And while patients in all 3 studies slowed during the pandemic, it did improve during 2022 as medical centers reopened for clinical research and patients return for their treatments.

這是 Duchenne 肌營養不良症獲得 FDA 孤兒產品開發資助的第一項研究。雖然所有 3 項研究中的患者在大流行期間都放緩了，但隨著醫療中心重新開放進行臨床研究和患者返回接受治療，情況在 2022 年確實有所改善。

Last quarter, we announced that enrollment in our Phase II asthma or AERD study have been closed. A total of 56 patients were enrolled in 19 medical centers across the United States. This randomized placebo-controlled trial was designed to evaluate whether ifetroban can improve the sinonasal symptoms associated with AERD. Top line results will be announced after completion of the study's data analysis.

上個季度，我們宣布我們的 II 期哮喘或 AERD 研究的註冊已經結束。全美 19 個醫療中心共招募了 56 名患者。這項隨機安慰劑對照試驗旨在評估 ifetroban 是否可以改善與 AERD 相關的鼻竇症狀。研究數據分析完成後將公佈最高結果。

Meanwhile, researchers at Brigham and Women's Hospital completed a separate investigator-initiated study evaluating the impact of ifetroban on the aspirin desensitation process in patients with AERD, the asthma condition I've mentioned. The single center study closed early due to poor patient accrual and because they exhausted their funding. The researchers found no statistical difference in the dose of aspirin needed to improve the patient's total nasal symptoms. Full results of the study will be provided and the manuscript that the current -- that researchers currently pursuing for publication.

與此同時，布萊根婦女醫院的研究人員完成了一項由研究者發起的獨立研究，評估 ifetroban 對 AERD（我提到的哮喘病）患者阿司匹林脫敏過程的影響。單中心研究由於患者招募不佳以及他們用盡了資金而提前結束。研究人員發現改善患者總體鼻部症狀所需的阿司匹林劑量沒有統計學差異。將提供研究的全部結果和當前的手稿——研究人員目前正在尋求出版。

It should be noted that the results for this investigator study were inconsistent with those previously published in preclinical findings and that study also differs in design from our corporate-sponsored studies. Meanwhile, we're also working on an application to the FDA for a fourth Phase II clinical program, which will evaluate the use of ifetroban to treat patients with interstitial lung disease. We look forward to sharing findings from all of these studies as they become available and then building upon those discoveries to continue ifetroban's development, which we believe has the potential to benefit many patients with orphan diseases that represent unmet medical needs.

應該注意的是，這項調查研究的結果與之前發表的臨床前研究結果不一致，而且該研究在設計上也不同於我們公司贊助的研究。同時，我們還在向 FDA 申請第四個 II 期臨床項目，該項目將評估使用 ifetroban 治療間質性肺病患者的效果。我們期待在所有這些研究可用時分享它們的發現，然後在這些發現的基礎上繼續開發 ifetroban，我們相信它有可能使許多代表未滿足醫療需求的孤兒疾病患者受益。

With that, I'd now like to turn it over to our Chief Financial Officer, John Hamm, to review our 2022 financial results. John?

有了這個，我現在想把它交給我們的首席財務官約翰哈姆來審查我們 2022 年的財務業績。約翰？

Thank you, A.J. For the 3 months ended December 31, 2022, net revenue from continuing operations were $9.1 million, a nearly 10% increase over the $8.3 million in revenue recorded during the prior year period. Net revenues by product for the fourth quarter of 2022 included $2.4 million for Sancuso, $3.8 million for Kristalose, $1.5 million for Vibativ and $1.8 million for Caldolor. As a reminder, due to quarterly fluctuations in our customers' purchases, we believe our performance should be assessed based on annual sales results. With that in mind, I'm pleased to report that net revenues for the full year 2022 were $42 million, up 17% over the $36 million in revenue in 2021. Full year product revenues totaled $15.2 million for Kristalose, $13.2 million for Sancuso, $7.5 million for Vibativ and $4.8 million for Caldolor.

謝謝你，A.J.截至 2022 年 12 月 31 日止三個月，來自持續經營業務的淨收入為 910 萬美元，比去年同期的 830 萬美元增長近 10%。 2022 年第四季度按產品劃分的淨收入包括 Sancuso 的 240 萬美元、Kristalose 的 380 萬美元、Vibativ 的 150 萬美元和 Caldolor 的 180 萬美元。提醒一下，由於客戶購買量的季度波動，我們認為我們的業績應該根據年度銷售結果進行評估。考慮到這一點，我很高興地報告 2022 年全年的淨收入為 4200 萬美元，比 2021 年的 3600 萬美元增長 17%。全年產品收入總計 Kristalose 為 1520 萬美元，Sancuso 為 1320 萬美元， Vibativ 為 750 萬美元，Caldolor 為 480 萬美元。

Turning to our expenditures. Total operating expenses for the fourth quarter were $11.4 million compared to $12.7 million for the prior year period. Total operating expenses for 2022 were $47.7 million, up from $43.7 million during the prior year. The addition of expenses from our newest acquisition remained a primary driver of this increase, including the costs associated with the products' amortization, distribution, marketing and selling. The net loss for the quarter was approximately $2.5 million, and we had a net loss of $5.6 million for the year.

談到我們的支出。第四季度的總運營費用為 1140 萬美元，而去年同期為 1270 萬美元。 2022 年的總運營費用為 4770 萬美元，高於上年的 4370 萬美元。我們最新收購的費用增加仍然是這一增長的主要驅動因素，包括與產品攤銷、分銷、營銷和銷售相關的成本。本季度的淨虧損約為 250 萬美元，全年淨虧損為 560 萬美元。

When noncash expenses are added back, the resulting adjusted earnings for the year were $2.1 million or $0.14 a share, which was a significant $3.3 million improvement on the adjusted loss of $1.2 million last year. Also, please note that the adjusted earnings calculations do not include the additional benefit of the $1.5 million of Vibativ and Sancuso cost of goods during the quarter, which was a $4.8 million benefit for the full 2022 year. Those goods were received as part of each product's acquisition. As a result, and taking into account all of these items, total cash flow from operations was $8.5 million in 2022, a $2.2 million increase over the $6.3 million during the prior year. As a reminder, our financial statements have been significantly impacted by the Vibativ and Sancuso acquisitions.

如果將非現金支出加回去，調整後的當年收益為 210 萬美元或每股 0.14 美元，比去年調整後的虧損 120 萬美元大幅減少 330 萬美元。另外請注意，調整後的收益計算不包括本季度 150 萬美元的 Vibativ 和 Sancuso 商品成本的額外收益，這是 2022 年全年的 480 萬美元收益。這些貨物是作為每個產品採購的一部分收到的。因此，考慮到所有這些項目，2022 年運營現金流總額為 850 萬美元，比上年的 630 萬美元增加了 220 萬美元。提醒一下，我們的財務報表受到 Vibativ 和 Sancuso 收購的重大影響。

The financial terms for the Vibativ transaction included a $20 million payment upon closing and a subsequent $5 million milestone payment. We are also providing royalties based on product sales. I'm pleased to report that since Vibativ's launch in late 2018, it has delivered a total cash contribution of $31 million to our business and therefore, has begun generating a return on our $25 million investment.

Vibativ 交易的財務條款包括在交易結束時支付 2000 萬美元以及隨後支付的 500 萬美元里程碑付款。我們還根據產品銷售額提供特許權使用費。我很高興地報告，自 Vibativ 於 2018 年底推出以來，它已為我們的業務提供了 3100 萬美元的現金貢獻，因此，我們的 2500 萬美元投資已經開始產生回報。

We accounted for the Vibativ acquisition as a business combination. A total of $34 million in new assets were added as a result of the acquisition, which including approximately $21 million in inventory, $12 million of intangible assets and $1 million of goodwill. Due to the amortization of intangibles and the sale of inventory, the value of these assets totaled $16.8 million at the end of 2022.

我們將收購 Vibativ 視為一項業務合併。此次收購共增加了 3400 萬美元的新資產，其中包括約 2100 萬美元的存貨、1200 萬美元的無形資產和 100 萬美元的商譽。由於無形資產的攤銷和存貨的出售，這些資產的價值在 2022 年底總計 1680 萬美元。

Turning to the Sancuso acquisition. The financial terms included a $13.5 million payment upon closing, up to $3.5 million in milestone payments and tiered royalties on net product sales. Sancuso is off to a fine start delivering approximately $10 million in cash contribution during 2022.

談到對 Sancuso 的收購。財務條款包括交易結束時支付的 1350 萬美元、最高 350 萬美元的里程碑付款和產品淨銷售額的分級特許權使用費。 Sancuso 開局良好，在 2022 年提供了大約 1000 萬美元的現金捐助。

As with Vibativ, we accounted for the Sancuso acquisition as a business combination. We added a total of $19 million in new assets added as a result of the acquisition, including approximately $4 million in inventory and $14 million of intangible assets. The estimated value of these assets was $15.6 million at the end of the year. Previously, we renewed our line of credit for a new 3-year term. During the first quarter of 2022, we expanded our use of the facility to provide $20 million in capital. This new line of credit provided the funding for our most recent product acquisition. More recently, we amended the facility to increase our ability to fully utilize this line.

與 Vibativ 一樣，我們將對 Sancuso 的收購視為一項業務合併。由於收購，我們增加了總計 1900 萬美元的新資產，包括大約 400 萬美元的存貨和 1400 萬美元的無形資產。截至年底，這些資產的估計價值為 1560 萬美元。此前，我們將信用額度更新為新的 3 年期。在 2022 年第一季度，我們擴大了對該設施的使用，提供了 2000 萬美元的資金。這一新的信貸額度為我們最近的產品收購提供了資金。最近，我們修改了設施以提高我們充分利用這條生產線的能力。

Turning to our balance sheet. As of December 31, 2022, we had $93 million in total assets, including $20 million in cash and cash equivalents. Liabilities totaled $57 million, including $16 million on our credit facility. Total shareholders' equity was $36 million at the end of 2022. We continued our corporate share repurchase program in 2022 and through the end of December we purchased a total of 368,000 shares. These repurchases included those on the open market as well as those needed to fund the taxes associated with employee vested restricted shares. That's in addition to the 180,000 shares that Nordic Pharma returned to us.

轉向我們的資產負債表。截至 2022 年 12 月 31 日，我們擁有 9300 萬美元的總資產，其中包括 2000 萬美元的現金和現金等價物。負債總額為 5700 萬美元，其中包括我們信貸額度的 1600 萬美元。截至 2022 年底，股東權益總額為 3600 萬美元。我們在 2022 年繼續實施公司股票回購計劃，截至 12 月底，我們共購買了 368,000 股股票。這些回購包括公開市場上的回購以及為與員工歸屬限制性股票相關的稅收提供資金所需的回購。這還不包括 Nordic Pharma 返還給我們的 180,000 股股票。

Lastly, I'd like to note that Cumberland continues to hold over $53 million in tax net operating loss carryforwards with the majority resulting from the prior exercise of stock options. And that completes our financial report for the final quarter and year-end of 2022.

最後，我想指出 Cumberland 繼續持有超過 5300 萬美元的稅收淨營業虧損結轉，其中大部分來自先前行使的股票期權。這就完成了我們 2022 年最後一個季度和年底的財務報告。

Back to you, A.J.

回到你身邊，A.J.

Thank you, John. In July of 2022, we welcomed Martin Brown Jr. to our Board of Directors. Martin brought valuable legal, public company health care and civic experience to our Board, and he was previously a long-term board member of Brown-Forman Corporation, a New York Stock Exchange-listed company. We were deeply saddened, however, to lose 2 of our dedicated Board members over the last year, Joey Jacobs and Marty Cearnal. Each was an outstanding leader, a valued colleague and a dear friend to many. Joey Jacobs was a legendary beloved member of the health care community. He served on our Board of Directors for over a decade, where his support and guidance played a critical role in advancing our mission.

謝謝你，約翰。 2022 年 7 月，我們歡迎 Martin Brown Jr. 加入我們的董事會。 Martin 為我們的董事會帶來了寶貴的法律、上市公司醫療保健和公民經驗，他之前是紐約證券交易所上市公司 Brown-Forman Corporation 的長期董事會成員。然而，我們在去年失去了兩位敬業的董事會成員，Joey Jacobs 和 Marty Cearnal，我們對此深感悲痛。每個人都是傑出的領導者、寶貴的同事和許多人的摯友。喬伊·雅各布斯 (Joey Jacobs) 是一位深受醫療保健界喜愛的傳奇人物。他在我們的董事會任職超過十年，他的支持和指導在推進我們的使命方面發揮了關鍵作用。

As a member of various corporate and civic boards throughout our region, Joey was a sought-after mentor, whose sound advice and guidance was instrumental in growing many area health care organizations. Marty Cearnal, served as a member of our Board and joined our management team in 2008 to lead our commercial efforts. He built our entire marketing and sales organization, led our product launches and played a key role in our business development initiatives. Marty was such an integral part of our organization, and we're grateful to have a team of sales and marketing executives who have stepped up to ensure the business has continued to operate without interruption.

作為我們地區各種企業和公民委員會的成員，喬伊是一位廣受歡迎的導師，他的中肯建議和指導對許多地區醫療保健組織的發展起到了重要作用。 Marty Cearnal 擔任我們的董事會成員，並於 2008 年加入我們的管理團隊，領導我們的商業工作。他建立了我們的整個營銷和銷售組織，領導了我們的產品發布，並在我們的業務發展計劃中發揮了關鍵作用。 Marty 是我們組織中不可或缺的一部分，我們很高興有一支銷售和營銷主管團隊挺身而出，以確保業務繼續不間斷地運營。

So overall, we're pleased to share our progress over the past year. We remain focused on our mission of providing branded medicines to support patient care, and we're working to maximize the potential of our commercial brands, progressing our pipeline and continuing to pursue select acquisitions. In fact, our newest acquisition, Sancuso, has proven to have a positive impact on our business, and we're encouraged by its early success. We're honored to deliver to oncology patients throughout the country who need it and believe that the contributions from the product will continue to be a catalyst of growth for our company.

總的來說，我們很高興分享我們在過去一年中取得的進展。我們仍然專注於提供品牌藥物以支持患者護理的使命，我們正在努力最大限度地發揮我們商業品牌的潛力，推進我們的管道並繼續進行精選收購。事實上，事實證明，我們最新收購的 Sancuso 對我們的業務產生了積極影響，我們對其早期的成功感到鼓舞。我們很榮幸能夠為全國各地需要它的腫瘤患者提供產品，並相信該產品的貢獻將繼續成為我們公司增長的催化劑。

So with a new brand feature, an improving operating environment, a growing roster of partnerships and a robust pipeline, we're very optimistic about our future. And we look forward to delivering quality medicines to enhance patients' quality of life.

因此，憑藉新的品牌特色、改善的運營環境、不斷增加的合作夥伴名單和強大的渠道，我們對未來非常樂觀。我們期待提供優質藥物以提高患者的生活質量。

With that review and update, let's now open the call to any questions you may have. Operator, please proceed.

通過審查和更新，現在讓我們打開電話，回答您可能有的任何問題。接線員，請繼續。

(Operator Instructions) At this time, I'd like to turn the call back to management for closing remarks.

（操作員說明）此時，我想將電話轉回管理層以作結束語。

Okay. Well, thanks, everyone, for joining today's call. We do understand that many of you prefer a private discussion with management. And if so, please just reach out to us, and we'll be happy to get a call scheduled for you. As always, we appreciate your time, your interest in our company, and we look forward to providing you another update in the coming months.

好的。好吧，謝謝大家參加今天的電話會議。我們確實理解你們中的許多人更喜歡與管理層進行私下討論。如果是這樣，請聯繫我們，我們很樂意為您安排電話。一如既往，我們感謝您抽出時間，感謝您對我們公司的關注，我們期待在未來幾個月為您提供另一次更新。

Thank you, sir. Ladies and gentlemen, that concludes today's call. If you would like to listen to a replay of the discussion, please visit the Investor Relations section on Cumberland's website. I would like to thank you for your participation. You may now disconnect.

謝謝你，先生。女士們，先生們，今天的電話會議到此結束。如果您想收聽討論的重播，請訪問 Cumberland 網站上的投資者關係部分。感謝您的參與。您現在可以斷開連接。