Cumberland Pharmaceuticals Inc (CPIX) 2024 Q2 法說會逐字稿

Good afternoon. And welcome to Cumberland Pharmaceuticals second quarter 2024 financial report and company update. This call is being recorded at the company's request and will be archived on its website for one year from today's date.

午安.歡迎閱讀 Cumberland Pharmaceuticals 2024 年第二季財務報告和公司更新。應公司要求對此通話進行錄音，並將在其網站上存檔，自今日起保存一年。

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.

我現在想把它交給莫莉·阿加斯 (Molly Aggas)，她是道爾頓機構 (Dalton Agency) 的客戶主管，負責處理坎伯蘭 (Cumberland) 的通訊。莫莉，請繼續。

Hello, everyone. Thanks for joining us today. Earlier this afternoon, Cumberland issued a press release announcing the company's financial results as well as an operational update for the second quarter of 2024. The release, which includes the related financial tables, can be found on the company's website at www.cumberlandpharma.com.

大家好。感謝您今天加入我們。今天下午早些時候，坎伯蘭發布新聞稿，宣布該公司的財務業績以及 2024 年第二季的營運更新。新聞稿包括相關的財務表格，可在該公司網站 www.cumberlandpharma.com 上找到。

Cumberland's 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 Cumberland's brands, pipeline and partners. 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.

坎伯蘭的管理層將在今天的電話會議上分享這些財務表現的概述。他們還將提供公司的整體最新情況，包括對坎伯蘭品牌、管道和合作夥伴的討論。參加今天的電話會議的是 A.J.卡齊米，坎伯蘭執行長；托德·安東尼，組織發展副總裁；和首席財務官約翰·哈姆。

Please keep in mind that their discussions may include forward-looking statements as defined in the Private Securities Reform Act. Those statements reflect the company's current views and expectations concerning future events and may involve risks and uncertainties.

請記住，他們的討論可能包括《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目前對未來事件的看法和預期，可能涉及風險和不確定性。

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.

可能影響坎伯蘭未來業績的因素有很多，包括自然災害、經濟衰退、公共衛生流行病、國際衝突以及其他公司無法控制的因素。這些問題在坎伯蘭 10-K 表格的「風險因素」標題以及向 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做出的任何前瞻性陳述均受到這些風險因素的限制。

Despite the company's best efforts, actual results may differ materially from expectations. So 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.

儘管公司盡了最大努力，實際結果可能與預期有重大差異。因此，本次電話會議中共享的資訊僅應被視為截至今天的最新資訊。請記住，公司不負責更新任何前瞻性陳述，無論是由於新資訊還是由於未來的發展。

During today's call, there will also be references to several of Cumberlands' marketed brands. Full prescribing and safety information for each brand is included on the individual product websites and you can find links to those sites on the corporate website at www.cumberlandpharma.com.

在今天的電話會議中，還將提到坎伯蘭的幾個行銷品牌。每個品牌的完整處方和安全資訊均包含在各個產品網站上，您可以在公司網站 www.cumberlandpharma.com 上找到這些網站的連結。

The company will be providing some non-GAAP financial measures with respect to its performance. An explanation and reconciliation to GAAP measures can be found in the financial tables of the earnings release that was issued earlier this afternoon.

該公司將提供一些與其績效相關的非公認會計準則財務指標。對公認會計準則措施的解釋和調節可以在今天下午早些時候發布的收益報告的財務表格中找到。

If you have any questions, please hold them until the end of the call, at which point we'll be happy to answer them. Management is also prepared to hold a follow-up conversation after the call, if you prefer.

如果您有任何疑問，請在通話結束前提出，屆時我們將很樂意解答。如果您願意，管理層也準備在通話後進行後續對話。

With that introduction, I'll turn the call over to Cumberlands' Chief Executive Officer, A.J. Kazimi.

介紹完畢後，我會將電話轉給坎伯蘭郡的執行長 A.J.卡齊米。

Thank you, Molly. And good afternoon, everyone. We do appreciate your taking the time to join us today, as we share how the first half of the year has gone. On today's call, we'll provide a company update, as well as a review of our financial results for the second quarter of 2024. So let's get started.

謝謝你，莫莉。大家下午好。我們非常感謝您今天抽出時間加入我們，我們將分享今年上半年的情況。在今天的電話會議上，我們將提供公司最新動態以及 2024 年第二季財務業績回顧。那麼就讓我們開始吧。

Given the number of ongoing positive developments here at Cumberland, which we'll cover in today's call, we remain very optimistic about our future prospects. And we do believe, we're still on track to post double-digit revenue growth and deliver positive cash flow from operations in 2024.

鑑於坎伯蘭持續取得的積極進展（我們將在今天的電話會議中介紹），我們對未來的前景仍然非常樂觀。我們確實相信，我們仍有望在 2024 年實現兩位數的收入成長並帶來正的營運現金流。

During the second quarter, our line of FDA approved brands provided $9.9 million in net revenue, which represented 16% in sequential growth from the first quarter of the year. We also generated adjusted earnings of $0.2 million, which was a $0.8 million improvement over the prior period.

第二季度，我們的 FDA 核准品牌系列提供了 990 萬美元的淨收入，較今年第一季環比成長 16%。我們還產生了 20 萬美元的調整後收益，比上一期增加了 80 萬美元。

Our June ending balance sheet included $79 million in total assets. with $17 million in cash and investments. Total liabilities were $53 million, and shareholders' equity totaled $26 million.

我們 6 月期末的資產負債表包括 7,900 萬美元的總資產。擁有 1700 萬美元現金和投資。負債總額為 5,300 萬美元，股東權益總額為 2,600 萬美元。

With that financial overview, I'd next like to share several updates regarding our products, including a number of growth opportunities. First, we're pleased to share that Kristalose, our prescription strength laxative, is now covered on Wisconsin Medicaid plans. Also, we recently launched a campaign featuring the American Gastroenterological Association's guidelines that include Kristalose as a first-line treatment for opioid-induced constipation.

有了財務概覽，接下來我想分享一些關於我們產品的最新動態，包括一些成長機會。首先，我們很高興地告訴大家，我們的處方強力瀉藥 Kristalose 現已納入威斯康辛州醫療補助計劃。此外，我們最近發起了一項以美國胃腸病學協會指南為特色的活動，其中包括將 Kristalose 作為阿片類藥物引起的便秘的一線治療藥物。

Next, recall the federal NOPAIN Act, which was passed last year, is designed to provide special, favorable reimbursement for non-opioid products like Caldolor. The act is scheduled to go into effect in early 2025 for an initial three-year period. There was recently another request from CMS for new products to be considered for this special reimbursement and we will provide updated submission information next month.

接下來，回想去年通過的聯邦 NOPAIN 法案，旨在為 Caldolor 等非鴉片類產品提供特殊、優惠的報銷。該法案計劃於 2025 年初生效，最初為期三年。最近 CMS 又提出了一項要求考慮將新產品納入此項特殊報銷的請求，我們將在下個月提供更新的提交資訊。

Regarding Vibativ, our potent antibiotic, we're pleased to announce that we launched a new product package this summer. It's designed for smaller accounts that either don't have the space to store or the patient volume to support investment in larger quantities of the product.

關於我們的強效抗生素 Vibativ，我們很高興地宣布，我們在今年夏天推出了新產品包。它專為較小的帳戶而設計，這些帳戶要么沒有儲存空間，要么沒有患者數量來支持對大量產品的投資。

And we've now introduced new Cumberland packaged Sancuso, following the successful manufacture of the product at the newly FDA approved facility. Additionally, we continue to work with our partners in their efforts to advance Vibativ in several international markets which can significantly contribute to the brand's growth in the future.

繼 FDA 新批准的工廠成功生產該產品後，我們現在推出了新的 Cumberland 包裝 Sancuso。此外，我們將繼續與合作夥伴合作，努力推動 Vibativ 在多個國際市場的發展，這可以為該品牌未來的發展做出重大貢獻。

Tabuk Pharmaceuticals has obtained the final approval needed to commercialize Vibativ in Saudi Arabia. They've now begun ordering the product in preparation for its launch there, which is planned for later this year.

Tabuk Pharmaceuticals 已獲得 Vibativ 在沙烏地阿拉伯商業化所需的最終批准。他們現在已經開始訂購該產品，為該產品的推出做準備，並計劃於今年稍後推出。

SciClone Pharmaceuticals, our partner for the Chinese market, continues to respond to regulatory inquiries as they seek the approval for Vibativ in their country.

我們在中國市場的合作夥伴 SciClone Pharmaceuticals 繼續回應監管機構的詢問，尋求 Vibativ 在中國的批准。

And DB Pharm, our partner in South Korea who also distributes Caldolor, plans to submit additional manufacturing information based on the feedback they received from the Korean regulatory authorities.

我們在韓國的合作夥伴 DB Pharm 也分銷 Caldolor，計劃根據從韓國監管機構收到的回饋提交額外的生產資訊。

So with that financial update and operational overview, I'd now like to turn to Todd Anthony, Cumberland's Vice President, Organizational Development, to further discuss our team and our brands. Tom?

因此，在了解財務更新和營運概述後，我現在想請坎伯蘭組織發展副總裁托德·安東尼進一步討論我們的團隊和品牌。湯姆？

Thank you, A.J. As a reminder, we support our portfolio of FDA-approved medicines through three national sales divisions. Our hospital sales division calls on key institutional accounts across the country, while our field sales division covers select office-based physicians. And our newest, Cumberland Oncology, focuses on cancer clinics.

謝謝你，A.J.謹此提醒，我們透過三個國家銷售部門支持 FDA 核准的藥品組合。我們的醫院銷售部門呼叫全國各地的主要機構客戶，而我們的現場銷售部門則涵蓋精選的辦公室醫生。我們最新的坎伯蘭腫瘤科專注於癌症診所。

So now, an update for each of our major brands. As A.J. mentioned, we launched a new package for our Vibativ product this summer. This additional presentation is designed to overcome a barrier at smaller hospitals and infusion centers that use less of the product at a time, allowing them to better manage their costs and their workflow associated with the product.

現在，我們對每個主要品牌進行更新。正如 A.J.提到過，我們今年夏天為 Vibativ 產品推出了新包裝。此附加演示旨在克服一次使用較少產品的小型醫院和輸液中心的障礙，使他們能夠更好地管理與產品相關的成本和工作流程。

Vibativ is an intravenous antibiotic approved by the FDA for the treatment of hospital-acquired and ventilator-associated bacterial pneumonias as well as complicated skin and skin structure infections caused by certain gram-positive bacteria.

Vibativ 是 FDA 批准的一種靜脈注射抗生素，用於治療醫院獲得性和呼吸機相關的細菌性肺炎以及由某些革蘭氏陽性菌引起的複雜皮膚和皮膚結構感染。

In June, Antimicrobial Agents and Chemotherapy published a study evaluating Vibativ, which is telavancin for injection, its generic name, as a novel therapeutic against anthrax inhalation in the most dangerous forms of those infections. Researchers were particularly interested in finding alternatives to current antibiotics in case anthrax bacteria become resistant to them.

6 月，《抗菌藥物與化療》發表了一項研究，評估 Vibativ（注射用特拉萬星，其通用名）作為一種針對最危險形式的炭疽吸入感染的新型治療方法。研究人員特別感興趣的是尋找現有抗生素的替代品，以防炭疽細菌對它們產生抗藥性。

Researchers tested telavancin against 17 different anthrax strains in the lab to determine how well it could stop their growth. Additionally, they tested telavancin in rabbits that were infected with a deadly dose of airborne to another antibiotic, levofloxacin, and a placebo.

研究人員在實驗室中針對 17 種不同的炭疽菌株測試了特拉萬星，以確定它能在多大程度上阻止它們的生長。此外，他們還在另一種感染致命劑量空氣傳播的抗生素左氧氟沙星和安慰劑的兔子身上測試了特拉萬星。

The results show that telavancin was very effective at killing all the anthrax strains tested in the lab. In the preclinical study, all the animals treated with telavancin survived, and telavancin was better at clearing anthrax from the blood and organs than levofloxacin.

結果表明，特拉萬星能夠非常有效地殺死實驗室測試的所有炭疽菌株。在臨床前研究中，所有接受特拉萬星治療的動物均存活下來，特拉萬星在清除血液和器官中的炭疽方面比左氧氟沙星更好。

Based on these results, the researchers concluded that telavancin could potentially be an effective new treatment option for anthrax infections, especially if current antibiotics become less effective due to resistance.

基於這些結果，研究人員得出結論，特拉萬星可能成為炭疽感染的有效新治療選擇，特別是如果目前的抗生素因抗藥性而變得不那麼有效的話。

Antimicrobial resistance continues to pose a challenge in treating bacterial infections. While many recently introduced antibiotics are quickly losing the battle to fight the bacteria they were designed to kill because those bacteria have become drug resistant, Vibativ was specifically designed to kill drug resistant bacteria.

抗生素抗藥性持續對治療細菌感染構成挑戰。雖然許多最近推出的抗生素很快就失去了與它們旨在殺死的細菌的戰鬥，因為這些細菌已經產生了抗藥性，但 Vibativ 是專門為殺死抗藥性細菌而設計的。

Moving next to Kristalose, our prescription strength laxative packaged in a convenient pre-measured powder dose that dissolves quickly in just 4 ounces of water for a clear taste-free and grit-free solution.

接下來是 Kristalose，我們的處方強度瀉藥採用方便的預先計量的粉末劑量包裝，僅在 4 盎司水中即可快速溶解，形成透明、無味、無砂粒的溶液。

We found that Kristalose performs best in states where we have Medicaid coverage. Wisconsin recently added Kristalose to its Medicaid formulary and we are implementing a special initiative to announce the development in that market. Recall that we also have Medicaid coverage for the brand in both New York and Texas, two of the largest states for this product.

我們發現 Kristalose 在有醫療補助覆蓋的州表現最好。威斯康辛州最近將 Kristalose 添加到其醫療補助處方中，我們正在實施一項特別舉措來宣布該市場的發展。回想一下，我們還在紐約州和德克薩斯州（該產品最大的兩個州）對該品牌提供醫療補助。

We recently launched a campaign featuring the American Gastroenterological Association or AGA's, guidelines that include Kristalose as a first-line treatment option for opioid-induced constipation. As the guidelines state, constipation is by far the most common and debilitating gastrointestinal effect of opioids and some degree of constipation is near universal in patients taking opioid medications. We believe the AGA's recommendation will support the use of Kristalose in those patients. Kristalose continues to be our largest selling product and it's benefiting nicely from the support of our two co-promotion partners.

我們最近發起了一項以美國胃腸病學協會 (AGA) 為主題的活動，其中包括 Kristalose 作為阿片類藥物引起的便秘的一線治療選擇。如指南所述，便秘是迄今為止阿片類藥物最常見且令人衰弱的胃腸道影響，並且在服用阿片類藥物的患者中幾乎普遍存在某種程度的便秘。我們相信 AGA 的建議將支持在這些患者中使用 Kristalose。Kristalose 仍然是我們最暢銷的產品，並且從我們兩個共同推廣合作夥伴的支持中受益匪淺。

Let's shift now to Caldolor, our intravenous ibuprofen product. Recall that in April, we shared a special report evaluating the growing amount of data supporting the use of Caldolor as a standard of care for the treatment of pain and fever in adults, children, and infants as young as three months of age.

現在讓我們轉向 Caldolor，我們的靜脈注射布洛芬產品。回想一下，四月份，我們分享了一份特別報告，評估了越來越多的數據支持使用 Caldolor 作為治療成人、兒童和三個月大嬰兒疼痛和發燒的護理標準。

Takeaways from this special report included that intravenous ibuprofen results in significant reductions in temperature compared to placebo in adults and to acetaminophen in pediatric patients. Also administration of the product prior to surgery leads to patients waking up in significantly less post-surgical pain while also lessening or even eliminating the need for opioids. And the use of intravenous ibuprofen in a hospital emergency department for acute pain can minimize opioid requirements while achieving significant pain control. Finally, Caldolor should be considered a foundation for any multimodal pain regimen.

這份特別報告的要點包括，與成人安慰劑和兒科患者對乙醯氨基酚相比，靜脈注射布洛芬可顯著降低體溫。此外，在手術前服用該產品可以使患者醒來後的術後疼痛明顯減輕，同時也減少甚至消除對鴉片類藥物的需求。在醫院急診室使用靜脈注射布洛芬治療急性疼痛可以最大限度地減少阿片類藥物的需求，同時實現顯著的疼痛控制。最後，Caldolor 應被視為任何多模式疼痛治療方案的基礎。

Pain management has become one of the most common healthcare problems in the United States. As this new report states, comprehensive multimodal pain regimens have become key in preventing pain and optimizing pain control while minimizing the need for opioids. A non-steroidal anti-inflammatory drug like Caldolor can provide a cornerstone for many treatment protocols, and we are encouraged by the substantial database emerging from our studies in patients of all ages.

疼痛管理已成為美國最常見的醫療保健問題之一。正如這份新報告所述，全面的多模式疼痛治療方案已成為預防疼痛和優化疼痛控制同時最大限度地減少阿片類藥物需求的關鍵。像 Caldolor 這樣的非類固醇抗發炎藥物可以為許多治療方案提供基石，我們對所有年齡層患者的研究中出現的大量資料庫感到鼓舞。

With its new pediatric labeling, which was just approved last year, Caldolor is now the only non-opioid product approved to treat pain in infants that's delivered via an injection. The new indication was further supported by the publication of positive results from a clinical study investigating the safety and pharmacokinetics of Caldolor in newborns. We're very pleased to have further expanded the products labeling for use in patients of nearly all ages and have launched a marketing initiative highlighting this new indication.

憑藉去年剛獲得批准的新兒科標籤，Caldolor 現在是唯一被批准用於透過注射治療嬰兒疼痛的非鴉片類藥物產品。一項調查 Caldolor 在新生兒中的安全性和藥物動力學的臨床研究發表的積極結果進一步支持了這一新適應症。我們非常高興進一步擴大了產品標籤，以供幾乎所有年齡層的患者使用，並啟動了一項行銷計劃來強調這一新適應症。

Turning now to Sancuso, the first and only FDA approved prescription patch for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy. A new manufacturing facility for Sancuso was approved by the FDA, and we have successfully completed the first lots of Cumberland packaged product there. We began shipping these new supplies of our Cumberland branded product this summer.

現在轉向 Sancuso，這是 FDA 批准的第一個也是唯一一個處方貼劑，用於預防接受某些類型化療的患者的噁心和嘔吐。Sancuso 的新生產設施已獲得 FDA 批准，我們已在那裡成功完成了第一批 Cumberland 包裝產品。今年夏天，我們開始運送這些坎伯蘭品牌產品的新供應品。

We continue to support the product through our expanded oncology sales division. And we're already seeing a favorable impact from that expansion, leading us to plan to build upon to increase customer frequency and reach.

我們繼續透過擴大的腫瘤銷售部門來支持該產品。我們已經看到了這種擴張帶來的有利影響，這促使我們計劃在此基礎上增加客戶頻率和覆蓋範圍。

Meanwhile, our new manufacturing and distribution partner for Vaprisol has successfully produced the product in their facility. As we await FDA approval for making the branded product there, our partner is providing a special supply of compounded product in support of these critically ill patients. The companies will share in the sales of this compounded product.

同時，我們新的 Vaprisol 製造和分銷合作夥伴已在其工廠成功生產該產品。當我們等待 FDA 批准在那裡生產品牌產品時，我們的合作夥伴正在提供特殊的複合產品來支持這些危重患者。兩家公司將分享這種複合產品的銷售。

Recall, Vaprisol is the first and only intravenously administered vasopressin receptor antagonist, and it's used to raise serum sodium levels in hospitalized patients with hyponatremia, which is the most common electrolyte disorder among these patients.

回想一下，Vaprisol 是第一個也是唯一一個靜脈注射的加壓素受體拮抗劑，它用於提高住院低鈉血症患者的血清鈉水平，低鈉血症是這些患者中最常見的電解質紊亂。

Well, that completes my updates for today, and so I'll turn it back to you, A.J.

好吧，我今天的更新就這樣完成了，所以我會把它轉回給你，A.J.

Thank you, Todd. I'd like to take a few minutes to provide an update on our ongoing clinical programs. We've been evaluating our ifetroban product candidate, a selective thromboxane receptor antagonist and a series of clinical studies. It's now been dosed in nearly 1,400 subjects, resulting in an excellent safety profile as it's been well tolerated in those individuals.

謝謝你，托德。我想花幾分鐘時間介紹我們正在進行的臨床計畫的最新情況。我們一直在評估我們的候選產品伊非曲班（一種選擇性血栓素受體拮抗劑）和一系列臨床研究。目前已對近 1,400 名受試者進行了給藥，由於這些人對它的耐受性良好，因此具有出色的安全性。

We currently have three Phase 2 clinical programs underway evaluating ifetroban in patients with orphan diseases that represent unmet medical needs. We've initiated our newest clinical program in medical centers across the country with enrollment now underway for patients with idiopathic pulmonary fibrosis, the most common form of progressive fibrosing interstitial lung disease. This fighting fibrosis study is designed to enroll 128 patients in over 20 medical centers of excellence across the United States. Recent studies have shown that ifetroban can help both prevent and enhance resolution of lung fibrosis in multiple preclinical models.

我們目前正在進行三個 2 期臨床項目，評估伊非曲班對患有未滿足醫療需求的孤兒疾病患者的療效。我們已經在全國各地的醫療中心啟動了最新的臨床計劃，目前正在招募特發性肺纖維化患者，特發性肺纖維化是進行性纖維化間質性肺部疾病的最常見形式。這項對抗纖維化的研究旨在招募美國 20 多個卓越醫療中心的 128 名患者。最近的研究表明，伊非曲班可以幫助預防和增強多種臨床前模型中肺纖維化的消退。

Meanwhile, enrollment has significantly progressed in our two other company-sponsored Phase 2 clinical programs. The first involves patients with systemic sclerosis or scleroderma, a debilitating autoimmune disorder characterized by the diffuse fibrosis of skin and internal organs. And the other study is evaluating ifetroban in patients with cardiomyopathy associated with Duchenne muscular dystrophy, a rare and fatal genetic neuromuscular disease that results in deterioration of the skeletal, heart, and lung muscles.

同時，我們公司贊助的另外兩個二期臨床計畫的入組人數也取得了顯著進展。第一個涉及患有系統性硬化症或硬皮症的患者，這是一種使人衰弱的自體免疫疾病，其特徵是皮膚和內臟器官的瀰漫性纖維化。另一項研究正在評估伊非曲班對杜氏肌肉營養不良症相關的心肌病變患者的療效，杜氏肌肉營養不良症是一種罕見且致命的遺傳性神經肌肉疾病，會導致骨骼肌、心臟和肺肌肉惡化。

We've now received over $1 million in grant awards from the FDA to support this muscular dystrophy study. Enrollment in the younger patient group is complete, and we are now working to address enrollment in the older patient cohort.

我們現已從 FDA 獲得超過 100 萬美元的撥款來支持這項肌肉萎縮症研究。年輕患者組的登記工作已經完成，我們現在正在努力解決老年患者組的登記問題。

Well, today I'm pleased to announce that we've applied for two FDA designations for our muscular dystrophy product candidate. The first is orphan drug designation, which is granted to products that address rare or orphan diseases. Such designation can result in an expedited FDA review process, waiver of FDA fees, and an extended exclusivity period after product approval.

好吧，今天我很高興地宣布，我們已經為我們的肌肉營養不良候選產品申請了兩項 FDA 指定。第一個是孤兒藥稱號，授予治療罕見或孤兒疾病的產品。此類指定可以加快 FDA 審查流程、免除 FDA 費用以及延長產品批准後的獨佔期。

The second is a rare pediatric disease designation. which is given to products that address diseases that primarily affect children. Upon FDA approval, this designation may result in a valuable priority review voucher from the FDA that can be used to accelerate approval of another product. And we should hear back on both these applications later this year.

第二個是罕見兒科疾病名稱。這是針對主要影響兒童的疾病的產品。一旦 FDA 批准，此指定可能會導致 FDA 獲得有價值的優先審查憑證，可用於加速另一種產品的批准。我們應該會在今年稍後收到這兩項申請的回覆。

In addition to these company-sponsored programs, there are other preclinical and pilot patient studies of ifetroban underway, including several investigator initiated trials. We expect to have data available this year from studies, and we look forward to then sharing the results with you, and as we then decide on the best development path for ifetroban, our first new chemical entity, which we believe has the potential to benefit many patients.

除了這些公司贊助的計畫外，還有其他伊非曲班的臨床前和試驗患者研究正在進行中，包括幾項研究者發起的試驗。我們預計今年將獲得研究數據，我們期待與您分享結果，然後我們決定伊非曲班的最佳開發路徑，伊非曲班是我們的第一個新化學實體，我們相信它有潛力受益很多病人。

So with that update on our clinical studies, I'd now like to turn it over to our Chief Financial Officer, John Hamm, to review our second quarter financial results. John?

因此，隨著我們臨床研究的更新，我現在想將其移交給我們的財務長約翰·哈姆（John Hamm），以審查我們第二季度的財務業績。約翰？

Thank you, A.J. For the three months ended June 30th, 2024, net revenue from continuing operations was $9.9 million, an increase of 16% sequentially from the first quarter of 2024. Given the significant revenue growth, we continue to believe that our performance is best evaluated on an annual basis.

謝謝你，A.J.截至 2024 年 6 月 30 日的三個月，持續營運淨收入為 990 萬美元，較 2024 年第一季季增 16%。鑑於收入的顯著增長，我們仍然相信我們的業績最好以年度為基礎進行評估。

Net revenue by product for the second quarter of 2024 included $4.1 million for Kristalose, $2.5 million for Vibativ, $2.2 million for Sancuso, and $0.8 million for Caldolor.

2024 年第二季按產品劃分的淨收入包括 Kristalose 410 萬美元、Vibativ 250 萬美元、Sancuso 220 萬美元和 Caldolor 80 萬美元。

Total year-to-date net revenues were $18.3 million. Year-to-date product revenues totaled $7.3 million for Kristalose, $4.1 million for Vibativ, $4 million for Sancuso, and $2.3 million for Caldolor.

年初至今淨收入總額為 1,830 萬美元。今年迄今Kristalose 的產品收入總計為 730 萬美元，Vibativ 為 410 萬美元，Sancuso 為 400 萬美元，Caldolor 為 230 萬美元。

Turning to our expenditures, total operating expenses for the second quarter were $10.9 million. Year-to-date expenses totaled $21.2 million.

說到我們的支出，第二季的總營運支出為 1,090 萬美元。今年迄今費用總計2,120萬美元。

Net loss for the quarter was $1.1 million. And when the non-cash expenses are added back, the resulting adjusted earnings were $0.2 million, which was a $0.8 million improvement over the prior-year period. Also please note that the adjusted earnings calculations do not include the additional benefit of the $0.6 million of Vibativ and Sancuso cost of goods during the second quarter. Those goods represent a non-cash item as they were received as part of each product's acquisition. We're pleased to see that the additions of Vibativ and Sancuso to our product portfolio continually to positively impact our financial performance.

該季度淨虧損為 110 萬美元。當非現金費用加回時，調整後的收益為 20 萬美元，比去年同期增加了 80 萬美元。另請注意，調整後的收益計算不包括第二季 Vibativ 和 Sancuso 60 萬美元商品成本的額外收益。這些貨物代表非現金物品，因為它們是作為每種產品採購的一部分而收到的。我們很高興看到 Vibativ 和 Sancuso 不斷添加到我們的產品組合中，從而對我們的財務表現產生積極影響。

As a result of the Vibativ acquisition, a total of $34 million in new assets were added, including approximately $21 million in inventory, $12 million of intangible assets, and $1 million of goodwill. The financial terms for the Vibativ transaction included a $20 million payment upon closing, and a subsequent $5 million milestone payment. We also continue to provide royalties tied to product sales.

收購 Vibativ 後，總共增加了 3,400 萬美元的新資產，其中包括約 2,100 萬美元的庫存、1,200 萬美元的無形資產和 100 萬美元的商譽。Vibativ 交易的財務條款包括成交時支付 2,000 萬美元，以及隨後的 500 萬美元里程碑付款。我們也繼續提供與產品銷售相關的特許權使用費。

Sancuso added a total of $19 million in new assets, including $4 million in inventory and $14 million of intangibles. The estimated value of those assets was $11.6 million at the end of the second quarter.

Sancuso 總共增加了 1,900 萬美元的新資產，其中包括 400 萬美元的庫存和 1,400 萬美元的無形資產。截至第二季末，這些資產的估計價值為 1,160 萬美元。

We provided $13.5 million at closing for the Sancuso acquisition, and we also paid $1.5 million in milestone payments. There are ongoing royalties that we pay based on the brand sales.

我們在完成 Sancuso 收購時提供了 1350 萬美元，並且還支付了 150 萬美元的里程碑付款。我們持續根據品牌銷售額支付特許權使用費。

Turning to our balance sheet, as of June 30th, 2024, we had $78.5 million in total assets, including $17.3 million in cash and cash equivalents. Liabilities totaled $52.5 million, including $16.1 million on our credit facility. Total shareholder's equity was $26 million at the end of the quarter.

談到我們的資產負債表，截至 2024 年 6 月 30 日，我們的總資產為 7,850 萬美元，其中包括 1,730 萬美元的現金和現金等價物。負債總額為 5,250 萬美元，其中包括 1,610 萬美元的信貸額度。截至本季末，股東權益總額為 2,600 萬美元。

We continue to hold a bank line of credit, which holds up to $20 million in capital and provides the ability for Cumberland to increase the amount to $25 million under certain conditions. The interest rate is based on benchmark term SOFR and is subject to one financial covenant determined on a quarterly basis.

我們繼續持有銀行信貸額度，該額度最多可容納 2,000 萬美元的資本，並為坎伯蘭提供在某些條件下將金額增加至 2,500 萬美元的能力。利率以基準期限 SOFR 為基礎，並遵守按季度確定的一項財務契約。

During the second quarter, we continued our corporate share repurchase program, buying a total of 77,000 shares. These repurchases included those on the open market and those needed to fund the taxes associated with employee-vested restricted shares. We are also continuing the process of implementing new trading plans for our board members who will purchase Cumberland shares throughout the year to increase their holdings in the company.

第二季度，我們繼續實施公司股票回購計劃，總共購買了 77,000 股。這些回購包括公開市場上的回購以及繳納與員工歸屬的限制性股票相關的稅款所需的回購。我們也將繼續為董事會成員實施新的交易計劃，他們將在全年購買坎伯蘭股票以增加其在公司的持股。

Lastly, I'd like to note that Cumberland continues to hold over $52 million in tax net operating loss carry forwards, primarily resulting from the prior exercise of stock options.

最後，我想指出的是，坎伯蘭繼續持有超過 5,200 萬美元的稅淨營業虧損結轉，這主要是由於先前行使股票選擇權造成的。

And that completes our financial report for the second quarter of 2024.

我們 2024 年第二季的財務報告就此完成。

Back to you, A.J.

回到你身邊，A.J.

Thank you, John. Well, overall, we've had a successful first half of the year and we're pleased to report a strong second quarter financial performance. We remain dedicated to our mission of working together to provide unique products that improve the quality of patient care. We've pursued our mission by building a portfolio of FDA approved grants that feature outstanding safety and efficacy profiles and that can make a difference in patient lives.

謝謝你，約翰。嗯，總的來說，我們上半年取得了成功，我們很高興地報告第二季強勁的財務表現。我們始終致力於履行我們的使命，即共同努力提供獨特的產品，以提高患者護理的品質。我們透過建立 FDA 批准的資助組合來追求我們的使命，這些資助具有出色的安全性和有效性，並且可以改變患者的生活。

We're particularly encouraged to see the growing number of states adding Kristalose to their Medicaid formularies. And we continue to see the positive impact of our sales and marketing initiatives that are supporting Sancuso and Vibativ.

我們特別高興地看到越來越多的州將 Kristalose 添加到其醫療補助處方中。我們繼續看到支持 Sancuso 和 Vibativ 的銷售和行銷計劃所產生的正面影響。

Pleased to also share the publication highlighting Vibativ's potential as an effective treatment for anthrax inhalation, as well as the launch of our new packaging for the product.

我們也很高興與大家分享該出版物，該出版物強調了 Vibativ 作為炭疽吸入有效治療方法的潛力，並推出了該產品的新包裝。

We're also encouraged by the progress of ifetroban clinical studies as we continue to pursue therapeutic solutions for unmet medical needs.

我們也對伊非曲班臨床研究的進展感到鼓舞，因為我們將繼續為未滿足的醫療需求尋求治療解決方案。

And we'd like to point out, we have an active acquisition initiative underway as we seek selective FDA approved brands to add to our portfolio and bolt on to our infrastructure. We'll continue in our efforts and look forward to future opportunities to carry out our mission and report on our progress through the remainder of this year and beyond.

我們想指出的是，我們正在進行一項積極的收購計劃，因為我們正在尋求選擇性 FDA 批准的品牌來添加到我們的產品組合併鞏固我們的基礎設施。我們將繼續努力，並期待未來有機會履行我們的使命，並報告我們在今年剩餘時間及以後的進展。

So now let's open the call to any questions. Operator, please proceed.

現在讓我們開始電話詢問任何問題。接線員，請繼續。

(Operator Instructions)

（操作員說明）

Well, as we don't have any questions, we'd just like to thank everyone for joining today's call. We do understand that many of you prefer a private discussion with management. And if so, please feel free just to reach out and we'll be happy to get such a call held with you and have such a discussion. As always, we appreciate your time and your interest in Cumberland and we'll look forward to providing another update in the coming months.

好吧，由於我們沒有任何問題，我們只想感謝大家參加今天的電話會議。我們確實了解，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，請隨時與我們聯繫，我們很樂意與您進行這樣的通話並進行這樣的討論。像往常一樣，我們感謝您抽出寶貴的時間以及您對坎伯蘭的興趣，我們期待在未來幾個月內提供另一次更新。

Thank you. 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 now like to thank you all for your participation. You may now disconnect.

謝謝。女士們、先生們，今天的電話會議到此結束。如果您想收聽討論重播，請造訪坎伯蘭網站上的投資者關係部分。現在我要感謝大家的參與。您現在可以斷開連線。