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Operator
Operator
Good morning, everyone. My name is Todd, and I'll be your conference operator. At this time, I'd like to welcome everyone to Eagle Pharmaceuticals Fourth Quarter and Full Year 2022 financial results. (Operator Instructions) As a reminder, this conference call is being recorded today, March 13, 2022. It is now my pleasure to turn the floor over to Ms. Lisa Wilson, Investor Relations for Eagle Pharmaceuticals. Please go ahead.
大家,早安。我叫托德,我將擔任您的會議接線員。此時,我想歡迎大家閱讀 Eagle Pharmaceuticals 第四季度和 2022 年全年財務業績。 (操作員說明)提醒一下,本次電話會議將於今天 2022 年 3 月 13 日進行錄製。現在我很高興將發言權交給 Eagle Pharmaceuticals 投資者關係部的 Lisa Wilson 女士。請繼續。
Unidentified Company Representative
Unidentified Company Representative
Thank you, Tom. Welcome to Eagle Pharmaceuticals Fourth Quarter and Full Year 2022 Earnings Call. This is Lisa Wilson, Investor Relations for Eagle Pharmaceuticals. With me on today's call are Eagle's President and Chief Executive Officer, Scott Tarriff; Chief Financial Officer; Brian Cahill, and Vice President of Medical Affairs; Dr. Mike Greenberg.
謝謝你,湯姆。歡迎來到 Eagle Pharmaceuticals 第四季度和 2022 年全年收益電話會議。我是 Eagle Pharmaceuticals 投資者關係部門的 Lisa Wilson。 Eagle 的總裁兼首席執行官斯科特·塔里夫 (Scott Tarriff) 和我一起參加今天的電話會議;首席財務官;醫療事務副總裁 Brian Cahill;邁克·格林伯格博士。
This morning, Eagle issued a press release detailing its financial results for the 3 months and full year ended December 31, 2022. This press release and a webcast of this call can be accessed through the Investors section of the Eagle website at eagleus.com.
今天上午,Eagle 發布了一份新聞稿,詳細介紹了其截至 2022 年 12 月 31 日的三個月和全年的財務業績。可通過 Eagle 網站 eagleus.com 的投資者部分訪問本新聞稿和本次電話會議的網絡直播。
Before we get started, I would like to remind everyone that any statements made on today's conference call that express a belief, expectation, projection, forecast, anticipation or intent regarding future events and the company's future performance may be considered forward-looking statements as defined by the Private Securities Litigation Reform Act. These forward-looking statements are based on information available to Eagle Pharmaceuticals management as of today and involve risks and uncertainties, including those noted in this morning's press release and our filings with the SEC.
在我們開始之前,我想提醒大家,在今天的電話會議上發表的任何表達對未來事件和公司未來業績的信念、期望、預測、預測、預期或意圖的陳述都可能被視為前瞻性陳述定義根據《私人證券訴訟改革法》。這些前瞻性陳述基於 Eagle Pharmaceuticals 管理層截至今日可獲得的信息,涉及風險和不確定性,包括今天上午的新聞稿和我們向美國證券交易委員會提交的文件中提到的那些。
Such forward-looking statements are not guarantees of future performance. Actual results may differ materially from those projected in the forward-looking statements. Eagle Pharmaceuticals specifically disclaims any intent or obligation to update these forward-looking statements, except as required by law. A telephone replay will be available shortly after completion of this call. You'll find the dial-in information in today's press release. The archived webcast will be available for 1 year on our website at eagleus.com.
此類前瞻性陳述並非對未來業績的保證。實際結果可能與前瞻性陳述中預測的結果存在重大差異。 Eagle Pharmaceuticals 明確否認更新這些前瞻性陳述的任何意圖或義務,除非法律要求。電話重播將在本次通話結束後不久提供。您將在今天的新聞稿中找到撥入信息。存檔的網絡廣播將在我們的網站 eagleus.com 上提供 1 年。
For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on March 13, 2023. Since then, Eagle may have made announcements related to the topics discussed, so please refer to the company's most recent press releases and SEC filings. We will be discussing non-GAAP financial measures during this conference call in addition to financial information prepared in accordance with U.S. GAAP. These non-GAAP financial measures should be considered in addition to, but not as a substitute for the information prepared in accordance with GAAP. A description of these non-GAAP financial measures and reconciliations of these non-GAAP financial measures to their most comparable GAAP measures are set forth in our earnings press release available on our website at eagleus.com.
為了那些可能正在收聽重播或存檔網絡廣播的人的利益,本次電話會議於 2023 年 3 月 13 日舉行並錄製。此後,Eagle 可能已經發布了與所討論主題相關的公告,因此請參閱公司最近的新聞稿和 SEC 文件。除了根據美國公認會計原則編制的財務信息外,我們還將在本次電話會議期間討論非公認會計原則財務措施。這些非 GAAP 財務措施應被視為補充,但不能替代根據 GAAP 編制的信息。這些非 GAAP 財務措施的描述以及這些非 GAAP 財務措施與其最具可比性的 GAAP 措施的調節情況在我們網站 eagleus.com 上的收益新聞稿中有所闡述。
And with that, I'll turn the call over to Eagle's President and CEO, Scott Tarriff.
有了這個,我將把電話轉給 Eagle 的總裁兼首席執行官 Scott Tarriff。
Scott L. Tarriff - Founder, President, CEO & Director
Scott L. Tarriff - Founder, President, CEO & Director
Thank you, Lisa. Good morning, everyone, and thank you for joining our call today. 2022 was an outstanding year for Eagle. Our adjusted non-GAAP earnings per diluted share was $7.79 for the full year 2022 compared with $1.68 adjusted non-GAAP earnings per diluted share posted in 2021, our previously best full year.
謝謝你,麗莎。大家早上好,感謝您今天加入我們的電話會議。 2022 年對 Eagle 來說是傑出的一年。 2022 年全年調整後非 GAAP 攤薄每股收益為 7.79 美元,而 2021 年公佈的調整後非 GAAP 攤薄每股收益為 1.68 美元,這是我們此前最好的全年。
We earned $132 million in adjusted non-GAAP EBITDA in '22. This is a very significant achievement for a company of our size. This $7.79 more than triple last year's non-GAAP earnings per diluted share and came in at the top end of our expectations for 2022. The fourth quarter of 2022, our adjusted non-GAAP earnings per diluted share was $1.10 compared with $0.83 in the fourth quarter of the prior year.
我們在 22 年獲得了 1.32 億美元的調整後非 GAAP EBITDA。對於我們這樣規模的公司來說,這是一項非常重大的成就。這 7.79 美元是去年非 GAAP 攤薄後每股收益的三倍多,達到了我們對 2022 年預期的上限。2022 年第四季度,我們調整後的非 GAAP 攤薄後每股收益為 1.10 美元,而第四季度為 0.83 美元前一年的四分之一。
Adjusted non-GAAP net income grew by 31.8% to $14.4 million in Q4 of '22, up from $11 million in Q4 of '21, our earnings per share in the past few years have been strong, and we expect that to continue in 2023. It's not just that we tripled our adjusted non-GAAP earnings per diluted share year-over-year. It's how we did it.
調整後的非 GAAP 淨收入從 21 年第四季度的 1100 萬美元增長 31.8% 至 22 年第四季度的 1440 萬美元,我們過去幾年的每股收益一直很強勁,我們預計這種情況將在 2023 年繼續. 這不僅僅是我們調整後的非 GAAP 每股攤薄收益同比增長了兩倍。我們就是這樣做的。
Let me point out once again that this was accomplished mostly organically. We have not raised any money through equity or debt finances in about 7 years. In fact, we used almost $250 million since 2016 to buy back our stock through our share repurchase program. In '22, we also spent about $100 million combined in cash and Eagle shares to acquire Acacia Pharma and its two commercial acute care products, BARHEMSYS and BYFAVO, and we still have net cash and receivables after all of this.
讓我再次指出,這主要是有機地完成的。大約 7 年來,我們沒有通過股權或債務融資籌集任何資金。事實上,自 2016 年以來,我們使用了近 2.5 億美元通過我們的股票回購計劃回購了我們的股票。在 22 年,我們還花費了約 1 億美元的現金和 Eagle 股票來收購 Acacia Pharma 及其兩種商業急性護理產品 BARHEMSYS 和 BYFAVO ,在所有這一切之後我們仍然有淨現金和應收賬款。
Our cash and cash equivalents are held almost entirely at JPMorgan in operating accounts. And we have outstanding $63.8 million of debt on our $150 million credit facility with JPMorgan. As of today, we hold less than $1 million in a small number of accounts at Silicon Valley Bank, with no individual count in excess of $250,000. Not only are we in very strong financial shape, but it places us in a good position to acquire assets or companies.
我們的現金和現金等價物幾乎全部在摩根大通的經營賬戶中持有。我們與摩根大通的 1.5 億美元信貸安排中有 6380 萬美元的未償債務。截至今天,我們在矽谷銀行的少數賬戶中持有不到 100 萬美元,沒有一個賬戶超過 250,000 美元。我們不僅財務狀況非常強勁,而且使我們處於收購資產或公司的有利位置。
Eagle has successfully managed expenses and had strong profitability. We expect to earn $74 million to $80 million of adjusted non-GAAP EBITDA in '23. Assuming the midrange of this '23 guidance, this would represent a compound annual growth rate for the 4-year period of 2020 to 2023 of 6%.
Eagle 成功地管理了開支並擁有強勁的盈利能力。我們預計 23 年調整後的非 GAAP EBITDA 將獲得 7400 萬至 8000 萬美元。假設這個 23 年指南的中間值,這將代表 2020 年至 2023 年 4 年期間 6% 的複合年增長率。
As an organization, we are keenly focused on developing important products for the patients who need them. At the same time, we have tried to achieve this in a manner that creates profitability. I doubt our mindset will change in the near term.
作為一個組織,我們非常專注於為需要它們的患者開發重要產品。與此同時,我們試圖以創造盈利的方式實現這一目標。我懷疑我們的心態會在短期內發生變化。
Let's discuss the strength of our year. Our fourth quarter '22 gross margin reflects both the expiration of our 10% bendamustine royalty and the buy down of our PEMFEXY. We expect these positive impacts to continue in '23. I will point out that in the fourth quarter '22, we had just over $12 million of PEMFEXY net sales and exited the quarter with a 6% share of the U.S. market in community oncology. We previously stated that we anticipated doubling that share to 12% by the end of the first quarter of '23, and it continues to be our expectation as we have already captured 10% share through February.
讓我們討論一下我們這一年的實力。我們 22 年第四季度的毛利率反映了我們 10% 苯達莫司汀特許權使用費的到期和我們 PEMFEXY 的買斷。我們預計這些積極影響將在 23 年繼續。我要指出的是,在 22 年第四季度,我們的 PEMFEXY 淨銷售額剛剛超過 1200 萬美元,並以 6% 的美國社區腫瘤市場份額退出本季度。我們之前曾表示,我們預計到 23 年第一季度末,這一份額將翻一番,達到 12%,這仍然是我們的預期,因為我們已經在 2 月份獲得了 10% 的份額。
In '22, PEMFEXY net sales reached $67 million. We expected net sales of PEMFEXY in '23 will be higher than $67 million. As a reminder, in Q4 of '22, we reduced future royalties on PEMFEXY profits in exchange for a onetime payment of $15 million to eliminate the royalty on the first $85 million of profit on PEMFEXY, beginning October 1, '22, and for a reduced royalty thereafter.
22 年,PEMFEXY 的淨銷售額達到 6700 萬美元。我們預計 23 年 PEMFEXY 的淨銷售額將超過 6700 萬美元。提醒一下,在 22 年第 4 季度,我們減少了 PEMFEXY 利潤的未來特許權使用費,以換取一次性支付 1500 萬美元,以消除從 22 年 10 月 1 日開始的 PEMFEXY 前 8500 萬美元利潤的特許權使用費,以及此後減少了版稅。
But we speak now to our bendamustine sales and profitability and provide an update on where we are thus far in the first quarter of '23. In '22, we had year-over-year revenue growth in both, BELRAPZO and TREAKISYM, net revenues of 42% and 97%, respectively, while BENDEKA declined. In total, our bendamustine franchise revenue grew in '22 over '21. As we have discussed many times, the bendamustine franchise faced competition for the first time on December 7, '22.
但我們現在談到我們的 bendamustine 銷售和盈利能力,並提供我們在 23 年第一季度迄今為止的最新情況。 22 年,BELRAPZO 和 TREAKISYM 的收入同比增長,淨收入分別增長 42% 和 97%,而 BENDEKA 則有所下降。總的來說,我們的苯達莫司汀特許經營收入在 22 年比 21 年有所增長。正如我們多次討論的那樣,苯達莫司汀特許經營權在 2022 年 12 月 7 日首次面臨競爭。
Eagle's strong fourth quarter of '22 earnings reported today and just discussed obviously include those 3 weeks of competition in December. Based on IQVIA data through February 24, BENDEKA and BELRAPZO hold an 88% share of the U.S. bendamustine market where historically, those two products have held about a 90% share.
Eagle 今天公佈的 22 年第四季度強勁收益和剛剛討論的顯然包括 12 月份那 3 週的競爭。根據截至 2 月 24 日的 IQVIA 數據,BENDEKA 和 BELRAPZO 佔據了美國苯達莫司汀市場 88% 的份額,而從歷史上看,這兩種產品佔據了約 90% 的份額。
We continue to believe that BENDEKA is a meaningfully superior oncology product for patients and healthcare providers compared to TREANDA or generic TREANDA and that we'll continue to maintain strong market share positions throughout '23. As we've been saying for some time, we expect BENDEKA and BELRAPZO to maintain approximately 75% of our gross profit in '23 compared to '22. In the nearly 90 days since competition ended the market -- entered the market, we can see that our products are holding up quite well relative to our forecast erosion to support our expectation. Let me also point out that we no longer pay the 10% royalty in our bendamustine products, a royalty obligation that came out of gross profits until it expired in Q4 of '22 and had a lifetime cap.
我們仍然相信,與 TREANDA 或仿製藥 TREANDA 相比,BENDEKA 對於患者和醫療保健提供者來說是一種有意義的卓越腫瘤學產品,並且我們將在整個 23 年繼續保持強大的市場份額。正如我們一段時間以來一直在說的那樣,我們預計 BENDEKA 和 BELRAPZO 與 22 年相比,23 年的毛利潤將保持在 23 年左右的 75% 左右。在競爭結束市場 - 進入市場後的近 90 天裡,我們可以看到我們的產品相對於我們的預測侵蝕保持得很好,以支持我們的預期。我還要指出,我們不再支付苯達莫司汀產品 10% 的特許權使用費,這是一項從毛利潤中產生的特許權使用費,直到它在 22 年第四季度到期並且有一個終身上限。
Turning now to the Acacia products, BARHEMSYS and BYFAVO. Although still a small base, but nearly $1.5 million in combined sales of BARHEMSYS and BYFAVO, in the second half of '22 represents a doubling from Acacia's reported net sales of $722,000 for these two products in the second half of '21. In '22, sales for the 2 products included $1.2 million by Acacia prior to the closing of our acquisition of the company on June 8 and $1.6 million by Eagle post-close.
現在轉向 Acacia 產品 BARHEMSYS 和 BYFAVO。儘管基數仍然很小,但 22 年下半年 BARHEMSYS 和 BYFAVO 的總銷售額接近 150 萬美元,這比 Acacia 在 21 年下半年報告的這兩種產品的淨銷售額 722,000 美元翻了一番。在 22 年,這兩種產品的銷售額包括 Acacia 在我們於 6 月 8 日完成對該公司的收購之前的 120 萬美元和 Eagle 在收盤後的 160 萬美元。
Keep in mind that Q1 of '23 is the first quarter in which we have our full size and fully trained sales team. We are extremely encouraged and hopeful, the growth trends will continue. Both products are patent protected until 2031.
請記住,23 年第一季度是我們擁有完整規模和訓練有素的銷售團隊的第一個季度。我們非常鼓舞和希望,增長趨勢將繼續下去。這兩種產品在 2031 年之前均受專利保護。
Net sales of RYANODEX increased year-over-year by 19% for the full year '22 and vasopressin and PEMFEXY, our two new launches in '22, generated $131 million combined in net sales in '22. During the first quarter of '23, we decided to exit the vasopressin market by discontinuing all related manufacturing and halting sales beyond the current inventory levels. So this is our opportunity to proudly discuss our record year in '22. The question in everybody's mind is what about '23 and beyond.
RYANODEX 的淨銷售額在 22 年全年同比增長 19%,我們在 22 年推出的兩款新產品加壓素和 PEMFEXY 在 22 年的淨銷售額合計達到 1.31 億美元。在 23 年第一季度,我們決定停止所有相關製造並停止銷售超出當前庫存水平的產品,從而退出加壓素市場。因此,這是我們自豪地討論我們在 22 年創紀錄的一年的機會。每個人心目中的問題是 23 歲及以後的情況。
Once again, as we've indicated in the past, we believe our product and pipeline opportunities are collectively strong with seven commercial products on the market and three exciting pipeline programs. Our guidance of $74 million to $80 million of adjusted non-GAAP EBITDA for full year '23 would represent a historical record, second to our record year for adjusted non-GAAP EBITDA in '22.
再一次,正如我們過去所指出的那樣,我們相信我們的產品和管道機會共同強大,市場上有七種商業產品和三個令人興奮的管道計劃。我們對 23 年全年調整後非 GAAP EBITDA 的 7400 萬美元至 8000 萬美元的指導將創造歷史記錄,僅次於我們在 22 年調整後的非 GAAP EBITDA 的創紀錄年份。
Taking a look even beyond '23, as we have indicated in the past, Eagle desires to make an accretive acquisition for additional patent protected assets to solidify our growth for several years. This brings us to our cash and balance sheet. We are being very selective but we believe we have the ability to make a meaningful acquisition, one that we'd expect to potentially go a long way in positioning Eagle as a growth company for many years to come.
正如我們過去所指出的那樣,放眼 23 年後,Eagle 希望通過增值收購獲得更多受專利保護的資產,以鞏固我們未來幾年的增長。這將我們帶到了我們的現金和資產負債表。我們非常有選擇性,但我們相信我們有能力進行有意義的收購,我們預計這一收購可能會在未來許多年將 Eagle 定位為一家成長型公司。
If we can accomplish this, while we work towards our objective for BARHEMSYS and BYFAVO, we believe it would have a huge impact on our ability of future growth is our belief that our pipeline opportunities offer not only potentially first-in-class products, which could have significant impact on treatment options. But the potential market could possibly have dramatic impact on Eagle size and value if successful. The significant pipeline opportunities include ENA-001, investigational one-of-a-kind new chemical entity. It is an agnostic respiratory stimulant being developed by Enalare for the potential treatment of postoperative respiratory depression, community drug overdose and apnea of prematurity, for which FDA granted orphan drug designation in Q4 '22.
如果我們能做到這一點,同時我們努力實現 BARHEMSYS 和 BYFAVO 的目標,我們相信這將對我們未來的增長能力產生巨大影響,我們相信我們的管道機會不僅提供潛在的一流產品,可能對治療方案產生重大影響。但如果成功,潛在市場可能會對 Eagle 的規模和價值產生巨大影響。重要的管道機會包括 ENA-001,研究中的一種新化學實體。它是一種不可知的呼吸興奮劑,由 Enalare 開發,用於潛在治療術後呼吸抑制、社區藥物過量和早產兒呼吸暫停,FDA 在 22 年第 4 季度授予孤兒藥物稱號。
As a reminder, we acquired approximately a 17% equity stake in Enalare, in exchange for two upfront investments paid in August of '22 and February of '23, and we had an option to purchase the rest of the Enalare in the event specified milestones are achieved.
提醒一下,我們收購了 Enalare 大約 17% 的股權,以換取在 22 年 8 月和 23 年 2 月支付的兩項前期投資,並且我們可以選擇在指定的里程碑事件中購買 Enalare 的其餘部分實現了。
CAL02, a novel first-in-class broad spectrum and the (inaudible) agent for the treatment of severe community-acquired bacterial pneumonia, for which a global Phase II study is underway with 276 expected patients in 120 centers expected in 22 countries. And our NDA for Landiolol is under FDA review. The filing seeks approval for Landiolol for the short-term reduction of ventricular rate in patients with super ventricular tachycardia, including atrial fibrillation and atrial flutter.
CAL02,一種新型一流的廣譜藥物和(聽不清)藥物,用於治療嚴重的社區獲得性細菌性肺炎,目前正在進行一項全球 II 期研究,預計將在 22 個國家/地區的 120 個中心對 276 名預期患者進行研究。我們的 Landiolol NDA 正在接受 FDA 審查。該申請尋求批准 Landiolol 用於短期降低室性心動過速患者的心室率,包括心房顫動和心房撲動。
We expect to have informative data readout on analog and CAL02 in about a year or so. In the meantime, in '23, we are projected to use cash to support Enalare's ENA-001 through an additional equity investment. And for CAL02, the R&D expense of about $35.5 million to $37.5 million combined. This does not include any cash that would be required in the event that Enalare achieved certain milestones or that we exercised our option to purchase the remaining shares of Enalare.
我們希望在大約一年左右的時間內在模擬和 CAL02 上讀出信息豐富的數據。與此同時,在 23 年,我們預計將通過額外的股權投資使用現金來支持 Enalare 的 ENA-001。而對於 CAL02,研發費用合計約為 3550 萬至 3750 萬美元。這不包括 Enalare 實現某些里程碑或我們行使選擇權購買 Enalare 剩餘股份時所需的任何現金。
As we transition into a diversified pharmaceutical company, we see two avenues open to us to meet this goal, clinical development and acquisitions. For now, we plan to balance both, acquired Acacia Pharma and hope to make an additional acquisition. We recognize that clinical development carries more risk but with a potentially higher return.
隨著我們轉型為一家多元化的製藥公司,我們看到了兩條途徑可以實現這一目標,即臨床開發和收購。目前,我們計劃平衡兩者,收購 Acacia Pharma 並希望進行額外的收購。我們認識到臨床開發會帶來更多風險,但可能帶來更高的回報。
To be clear, if we do not succeed with CAL02 and Enalare clinical programs, we intend to add the cash we would have spent on development in [any] company earnings back to the company and then concentrate on acquisitions. If we are successful, then we believe our investments will be money extremely well spent.
需要明確的是,如果我們在 CAL02 和 Enalare 臨床項目上沒有成功,我們打算將我們本應用於開發的現金添加到[任何]公司的收益中,然後集中精力進行收購。如果我們成功了,那麼我們相信我們的投資會物有所值。
In summary, 2022 was an outstanding year for Eagle, and we believe '23 is shaping up to be another very strong year. We hope to make a meaningful acquisition, focus our efforts on BARHEMSYS and BYFAVO to support the development of ENA-001 and work hard on advancing Landiolol and CAL02 over the next year or so and see how those turn out.
總而言之,2022 年對 Eagle 來說是傑出的一年,我們相信 23 年將成為又一個非常強勁的一年。我們希望進行有意義的收購,將我們的精力集中在 BARHEMSYS 和 BYFAVO 上,以支持 ENA-001 的開發,並在未來一年左右努力推進 Landiolol 和 CAL02,看看結果如何。
Well with that, I'll turn the call over to Brian Cahill to discuss our fourth quarter and full year financials. Brian?
那麼,我將把電話轉給布賴恩卡希爾,討論我們的第四季度和全年財務狀況。布萊恩?
Brian Joseph Cahill - CFO
Brian Joseph Cahill - CFO
Thank you, Scott, and good morning. In the fourth quarter of 2022, total revenue was $60.7 million compared to $42.3 million in Q4 of 2021, primarily reflecting continued revenue from sales of vasopressin and PEMFEXY which we launched in 2022 as well as the addition of BARHEMSYS and BYFAVO to our commercial portfolio.
謝謝你,斯科特,早上好。 2022 年第四季度,總收入為 6070 萬美元,而 2021 年第四季度為 4230 萬美元,這主要反映了我們在 2022 年推出的加壓素和 PEMFEXY 的銷售以及 BARHEMSYS 和 BYFAVO 添加到我們的商業產品組合中的持續收入。
Full year 2022 revenue was $316.6 million, compared to $171.5 million in 2021. Net product sales during the fourth quarter of 2022 were $37.2 million compared to $16.2 million in Q4 of 2021. Full year 2022 net product sales were $214.5 million compared to $65 million in '21. Vasopressin net product sales were $3.6 million and PEMFEXY net product sales were $12.1 million in the fourth quarter of '22.
2022 年全年收入為 3.166 億美元,而 2021 年為 1.715 億美元。2022 年第四季度的產品淨銷售額為 3720 萬美元,而 2021 年第四季度為 1620 萬美元。2022 年全年產品淨銷售額為 2.145 億美元,而 2022 年第四季度為 6500 萬美元'21。 22 年第四季度,加壓素產品淨銷售額為 360 萬美元,PEMFEXY 產品淨銷售額為 1210 萬美元。
For the full year '22, vasopressin net product sales were $63.2 million and PEMFEXY sales were $67.5 million. Regarding vasopressin, during the first quarter of 2023, we notify customers and the FDA of our decision to withdraw from the vasopressin market. Inventory on hand and in distribution channels is expected to be depleted by the end of the second quarter of 2023. BELRAPZO net product sales were $11 million in the fourth quarter of '22 compared to $5.5 million in Q4 of 2021.
22 年全年,加壓素產品淨銷售額為 6320 萬美元,PEMFEXY 銷售額為 6750 萬美元。關於加壓素,在 2023 年第一季度,我們通知客戶和 FDA 我們決定退出加壓素市場。預計到 2023 年第二季度末庫存和分銷渠道中的庫存將耗盡。BELRAPZO 22 世紀第四季度的產品淨銷售額為 1100 萬美元,而 2021 年第四季度為 550 萬美元。
For the full year, BELRAPZO net product sales totaled $33.7 million compared to $23.7 million in 2021. Fourth quarter 2022 RYANODEX spend product sales were $7.2 million compared to $6.1 million in Q4 of 2021. Full year '22, net product sales of RYANODEX totaled $30.2 million compared to $25.3 million in 2021.
全年,BELRAPZO 產品淨銷售額總計 3370 萬美元,而 2021 年為 2370 萬美元。2022 年第四季度 RYANODEX 支出產品銷售額為 720 萬美元,而 2021 年第四季度為 610 萬美元。22 年全年,RYANODEX 的產品淨銷售額總計 30.2 美元百萬美元,而 2021 年為 2530 萬美元。
Q4 2022 royalty revenue was $23 million compared to $26.2 million in the prior year quarter. Full year 2022 royalty revenue totaled $98.3 million compared to $106.5 million in 2021. Royalty revenue includes royalties earned on sales of BENDEKA in the U.S. and TREAKISYM in Japan.
2022 年第四季度特許權使用費收入為 2300 萬美元,而去年同期為 2620 萬美元。 2022 年全年特許權使用費收入總計 9830 萬美元,而 2021 年為 1.065 億美元。特許權使用費收入包括在美國銷售 BENDEKA 和在日本銷售 TREAKISYM 獲得的特許權使用費。
During 2022, we recorded $3.8 million of other revenue for a cumulative sales milestone on sales of TREAKISYM in Japan by our marketing partner, SymBio. Gross margin was 67% in Q4 compared to 71% in the prior year quarter. This decrease was the result of the addition of product sales of vasopressin, PEMFEXY, BARHEMSYS and BYFAVO to our portfolio, which contribute lower margin than historical revenue mix, which has been dominated by BENDEKA royalties. Also compressing margin is the inclusion of amortization of intangible assets related to the newly acquired products and the reduction of the PEMFEXY buydown beginning on October 1, 2022, which will continue going forward.
在 2022 年期間,我們的營銷合作夥伴 SymBio 在日本銷售 TREAKISYM 的累計銷售里程碑記錄了 380 萬美元的其他收入。第四季度的毛利率為 67%,而去年同期為 71%。這一下降是由於我們的產品組合中增加了加壓素、PEMFEXY、BARHEMSYS 和 BYFAVO 的產品銷售,這些產品的利潤率低於歷史收入組合,而歷史收入組合一直由 BENDEKA 特許權使用費主導。同樣壓縮利潤率的是與新收購產品相關的無形資產攤銷以及從 2022 年 10 月 1 日開始減少 PEMFEXY 回購的減少,這將繼續下去。
On the expense front, R&D expenses were $7.2 million for the fourth quarter of '22 compared to $3.8 million in the prior year quarter. This increase is largely attributable to CMC and clinical trial spend on our CAL02 program. Excluding stock-based compensation and other noncash and nonrecurring items, fourth quarter 2022 non-GAAP R&D expense was $6.6 million. Full year 2022 R&D expenses were $34.1 million compared to $51.3 million in 2021, primarily reflecting the nonrecurrence of a $10 million upfront payment related to our license agreement with [CombiOxin], for CAL02 and a $5 million upfront payment related to our license agreement with AOP Orphan for LANDIOLOL.
在費用方面,22 年第四季度的研發費用為 720 萬美元,而去年同期為 380 萬美元。這一增長主要歸因於我們的 CAL02 計劃的 CMC 和臨床試驗支出。不包括基於股票的薪酬和其他非現金和非經常性項目,2022 年第四季度非 GAAP 研發費用為 660 萬美元。 2022 年全年研發費用為 3410 萬美元,而 2021 年為 5130 萬美元,主要反映了與我們與 [CombiOxin] 的 CAL02 許可協議相關的 1000 萬美元預付款和與 AOP 的許可協議相關的 500 萬美元預付款的非經常性LANDIOLOL 的孤兒。
lower headcount. Also lower headcount costs of $1.3 million and lower spend on vasopressin of $7.6 million. RYANODEX NDA-111 of $3.1 million and PEMFEXY of $2.2 million. This was partially offset by $10.7 million of CMC and clinical expenditure on our CAL02 program in 2022.
員工人數減少。此外,員工成本降低了 130 萬美元,加壓素支出降低了 760 萬美元。 RYANODEX NDA-111 為 310 萬美元,PEMFEXY 為 220 萬美元。這被 2022 年 CAL02 計劃的 1070 萬美元 CMC 和臨床支出部分抵消。
Excluding stock-based compensation and other noncash items, adjusted non-GAAP R&D expense for 2022 was $31.5 million. SG&A expenses in the fourth quarter of 2022 were $24.1 million compared to $20.3 million in the fourth quarter of 2021. This increase was driven by higher headcount and marketing spend related to our newly acquired products BARHEMSYS and BYFAVO and PEMFEXY, which launched in February of 2022.
不包括基於股票的薪酬和其他非現金項目,2022 年調整後的非 GAAP 研發費用為 3150 萬美元。 2022 年第四季度的 SG&A 費用為 2410 萬美元,而 2021 年第四季度為 2030 萬美元。這一增長是由於與我們新收購的產品 BARHEMSYS、BYFAVO 和 PEMFEXY 相關的員工人數和營銷支出增加,這些產品於 2022 年 2 月推出.
Excluding stock-based compensation and other noncash and nonrecurring items, fourth quarter '22 non-GAAP SG&A expense was $19.9 million. For the full year of 2022, SG&A expenses were $106.6 million compared to $75.3 million in 2021. This increase primarily reflects costs associated with the acquisition of Acacia, including severance expense and other deal costs. Also higher headcount and marketing spend related to our newly acquired products BARHEMSYS or BYFAVO and PEMFEXY, which launched in February of 2022.
不包括基於股票的薪酬和其他非現金和非經常性項目,22 年第四季度非 GAAP SG&A 費用為 1990 萬美元。 2022 年全年,SG&A 費用為 1.066 億美元,而 2021 年為 7530 萬美元。這一增長主要反映了與收購 Acacia 相關的成本,包括遣散費和其他交易成本。此外,與我們於 2022 年 2 月推出的新收購產品 BARHEMSYS 或 BYFAVO 和 PEMFEXY 相關的員工人數和營銷支出也有所增加。
Excluding stock-based compensation and other noncash items, adjusted non-GAAP SG&A expense for 2022 was $70 million. We expect our SG&A spend in 2023 on a non-GAAP basis to be between $68 million and $90 million. Net income for the fourth quarter of 2022 was $8.2 million or $0.63 per basic and $0.62 per diluted share compared to a net loss of $6.2 million or $0.48 per basic and diluted share in the prior year quarter.
不包括基於股票的薪酬和其他非現金項目,2022 年調整後的非 GAAP SG&A 費用為 7000 萬美元。我們預計 2023 年我們的 SG&A 支出按非 GAAP 計算將在 6800 萬美元至 9000 萬美元之間。 2022 年第四季度的淨收入為 820 萬美元或每股基本股 0.63 美元和每股攤薄股 0.62 美元,而去年同期淨虧損為 620 萬美元或每股基本股和攤薄股 0.48 美元。
For the full year 2022, net income totaled $35.6 million or $2.76 per basic and $2.73 per diluted share compared to a net loss of $8.6 million or $0.66 per basic and diluted share in 2021. Adjusted non-GAAP net income for the fourth quarter of 2022 was $14.4 million or $1.11 per basic and $1.10 per diluted share, compared to adjusted non-GAAP net income of $11 million or $0.85 per basic and $0.83 per diluted share in the prior year quarter.
2022 年全年淨收入總計 3560 萬美元或每股基本股 2.76 美元,稀釋後每股收益 2.73 美元,而 2021 年淨虧損為 860 萬美元或每股基本股和稀釋股 0.66 美元。2022 年第四季度調整後的非美國通用會計準則淨收入為 1440 萬美元或每股基本收益 1.11 美元和每股攤薄收益 1.10 美元,而去年同期調整後的非 GAAP 淨收入為 1100 萬美元或每股基本收益 0.85 美元和每股攤薄收益 0.83 美元。
For the full year 2022, adjusted non-GAAP net income totaled $101.8 million or $7.87 per basic and $7.79 per diluted share compared to adjusted non-GAAP net income of $22.3 million or $1.71 per basic and $1.68 per diluted share in 2021. For a full reconciliation of non-GAAP measures to the most comparable GAAP measures, please see the table at the end of our earnings press release.
2022 年全年,調整後的非 GAAP 淨收入總計 1.018 億美元,即每股基本收入 7.87 美元和稀釋後每股收入 7.79 美元,而 2021 年調整後的非 GAAP 淨收入為 2230 萬美元,即每股基本收入 1.71 美元,稀釋後每股收入 1.68 美元。非 GAAP 措施與最具可比性的 GAAP 措施的調節,請參閱我們的收益新聞稿末尾的表格。
Also please note, as disclosed in the footnotes to this morning's press release beginning in the fourth quarter of 2022, Eagle no longer exclude expenses for in-process research and development from its non-GAAP results. Historically, the company excluded these charges. These charges have been made -- these changes rather, have been made to align with the views expressed by the U.S. Securities and Exchange Commission. Prior periods have been recast to reflect these changes.
另請注意,正如今天上午的新聞稿腳註中所披露的那樣,從 2022 年第四季度開始,Eagle 不再從其非 GAAP 業績中排除正在進行的研發費用。從歷史上看,該公司不包括這些費用。這些指控已經作出——相反,這些變化是為了與美國證券交易委員會表達的觀點保持一致。之前的期間已被重新計算以反映這些變化。
As of December 31, 2022, following the completed acquisition and synergizing of Acacia, the company had $55.3 million in cash and cash equivalents, $72.4 million in net accounts receivable and $63.8 million in outstanding debt, resulting in $64 million in net cash plus receivables. In 2022, we repurchased [$18] million of our common stock as part of our share repurchase program. From August 2016 through December 31, 2022, Eagle has repurchased $46.1 million of its common stock. During the fourth quarter, we've refinanced our debt facility. The company now has a new 3-year $150 million facility with a bank group led by JPMorgan that includes a $50 million term loan A and a $100 million revolving credit facility. The terms, including covenants of this facility, has been publicly disclosed and are similar to those of the prior expiring facility.
截至 2022 年 12 月 31 日,在完成對 Acacia 的收購和協同後,公司擁有 5530 萬美元的現金和現金等價物、7240 萬美元的應收賬款淨額和 6380 萬美元的未償債務,從而產生 6400 萬美元的淨現金加應收賬款。 2022 年,作為股票回購計劃的一部分,我們回購了 [18] 萬美元的普通股。從 2016 年 8 月到 2022 年 12 月 31 日,Eagle 回購了價值 4610 萬美元的普通股。在第四季度,我們為我們的債務安排進行了再融資。該公司現在與摩根大通牽頭的銀行集團有一項為期 3 年的 1.5 億美元的新貸款,其中包括 5000 萬美元的定期貸款 A 和 1 億美元的循環信貸額度。該貸款的條款(包括契約)已公開披露,並且與之前到期貸款的條款類似。
With that, I'll ask the operator to open the call for questions. Operator, please go ahead.
有了這個,我會要求接線員打開問題電話。接線員,請繼續。
Operator
Operator
(Operator Instructions) Our first question comes from Brandon Folkes with Cantor Fitzgerald.
(操作員說明)我們的第一個問題來自 Brandon Folkes 和 Cantor Fitzgerald。
Brandon Richard Folkes - Analyst
Brandon Richard Folkes - Analyst
Congratulations on a very strong year. A few for me. Maybe just firstly, just on the [PEMFEXY] maybe just -- can you talk about the moving pieces around 2023 revenue? As you gain this market share, the dynamic that revenue should not track around the pace similar growth rate?
祝賀您度過了非常強勁的一年。一些給我。也許只是首先,就 [PEMFEXY] 也許只是 - 你能談談 2023 年收入的變化嗎?當你獲得這個市場份額時,收入的動態變化不應該跟上類似的增長率?
Scott L. Tarriff - Founder, President, CEO & Director
Scott L. Tarriff - Founder, President, CEO & Director
Can you repeat that again? Brandon, we last you for a second.
你能再重複一遍嗎?布蘭登,我們等你一會兒。
Brandon Richard Folkes - Analyst
Brandon Richard Folkes - Analyst
Sure. Apologies. So on PEMFEXY, can you just talk about some moving pieces around 2023 revenue as you're gaining market share, any dynamic that revenue should not track around about a similar growth rate?
當然。道歉。因此,在 PEMFEXY 上,隨著你獲得市場份額,你能否談談 2023 年左右收入的一些變化,收入不應該追踪類似增長率的任何動態?
Scott L. Tarriff - Founder, President, CEO & Director
Scott L. Tarriff - Founder, President, CEO & Director
I see. Well, thanks for the question, Brandon. Yes, so we are out in the marketplace with our sales force concentrating on PEMFEXY, we're thrilled about the growth that we've had so far. The announcement today, the $12 million in Q4 and then the market share of about 10% where we are today. And I think if I understand your question, it's really about how inventory levels relate to sales and how that shakes out in the course of the year. For the most part, our customers have acquired inventory in anticipation of their future growth.
我懂了。好吧,謝謝布蘭登的提問。是的,所以我們的銷售人員專注於 PEMFEXY 進入市場,我們對迄今為止的增長感到興奮。今天宣布,第四季度的 1200 萬美元,然後我們今天的市場份額約為 10%。而且我認為,如果我理解你的問題,那實際上是關於庫存水平與銷售的關係以及它在一年中的變化情況。在大多數情況下,我們的客戶購買庫存是為了預期未來的增長。
We expect the 10% to grow to 12% by the time we get through March and then grow beyond that standpoint. It may not track exactly from quarter-to-quarter with [script] activity. We'll just have to see how that all shakes out and to where the market share winds up. But at the end of the day, we'll expect to have sales in excess of last year's number of $67 million. And right now, we're on track. We're right where we thought we would be. We're hoping to have and still have high expectations that we're going to have a strong year for the product. And remember, the profitability of the product is improved this year as well, as we bought down that royalty payment. So it's an exciting year for us as it relates to PEMFEXY. Does that answer...
我們預計到 3 月時 10% 將增長到 12%,然後增長到超過這一點。它可能無法準確跟踪每個季度的 [腳本] 活動。我們只需要看看這一切是如何發生的,以及市場份額最終會在哪裡。但最終,我們預計銷售額將超過去年的 6700 萬美元。現在,我們走上正軌。我們就在我們認為我們會在的地方。我們希望並且仍然對該產品有一個強勁的一年抱有很高的期望。請記住,今年產品的盈利能力也有所提高,因為我們購買了特許權使用費。因此,這對我們來說是令人興奮的一年,因為它與 PEMFEXY 相關。那個回答...
Brandon Richard Folkes - Analyst
Brandon Richard Folkes - Analyst
Yes. And then maybe on BELRAPZO, now that we have the TREANDA generics on the market, is your strategy around that product changed at all?
是的。然後也許在 BELRAPZO 上,既然我們在市場上有 TREANDA 仿製藥,您圍繞該產品的策略是否有任何改變?
Timothy Francis Lugo - Co-Group Head of Biopharma Equity Research, Partner & Research Analyst
Timothy Francis Lugo - Co-Group Head of Biopharma Equity Research, Partner & Research Analyst
So we -- we are doing our best to protect our franchise. We have an oncology sales force that is very focused on the product. We just think we have two really good products, especially in BENDEKA, the 10-minute infusion. So BELRAPZO being a liquid product. I think we're just going to stay very focused. We've committed before or at least expressed that we thought we would be within this 25% loss, keeping 75% of our product, and you can see after the first 90 days, Brandon, we're really in very good shape.
所以我們——我們正在盡最大努力保護我們的特許經營權。我們有一支非常專注於產品的腫瘤學銷售隊伍。我們只是認為我們有兩種非常好的產品,尤其是 BENDEKA,即 10 分鐘輸液。所以 BELRAPZO 是一種液體產品。我認為我們將保持非常專注。我們之前已經承諾或至少表示我們認為我們會在這 25% 的損失範圍內,保留 75% 的產品,你可以在前 90 天后看到,Brandon,我們的狀態非常好。
We've been able to do a really nice job keeping our products. And we expect that we're just going to have a strong '23 as it relates to the bendamustine franchise, both BENDEKA and BELRAPZO, combined with what we've just articulated on PEMFEXY, we're expecting to have another strong year across the board with our products in '23. It's an exciting time for us.
我們在保留我們的產品方面做得非常好。我們預計我們將有一個強大的 23 年,因為它與 BENDEKA 和 BELRAPZO 的苯達莫司汀特許經營權相關,結合我們剛剛在 PEMFEXY 上闡述的內容,我們預計今年將有另一個強勁的表現在 23 年使用我們的產品登機。這對我們來說是一個激動人心的時刻。
Operator
Operator
(Operator Instructions) Our next question comes from Tim Lugo with William Blair.
(操作員說明)我們的下一個問題來自 Tim Lugo 和 William Blair。
Lachlan Hanbury-Brown - Associate
Lachlan Hanbury-Brown - Associate
It is Lachlan on for Tim. My congratulations on a strong 2022. So on PEMFEXY, those -- the market share that you provided is very useful. I was wondering if you can talk about how much of the market you call on with the sales force to help us think about sort of where that market share could get to? And then on -- yes. I'll leave it there.
蒂姆是拉克蘭。我祝賀 2022 年表現強勁。因此,在 PEMFEXY 上,你提供的市場份額非常有用。我想知道你是否可以談談你與銷售人員一起呼籲的市場份額,以幫助我們考慮市場份額可以達到的程度?然後 - 是的。我會把它留在那裡。
Scott L. Tarriff - Founder, President, CEO & Director
Scott L. Tarriff - Founder, President, CEO & Director
So let's start there, Lachlan. So our sales force covers the entire market. The market is split between commercial and the hospital market, the 340B market pretty evenly. We're mostly focused with the sales force on the community side, and those are the shares that we're referring to as the sharing community. So it's a big marketplace. We're very focused on it. We expect the share to continue to grow throughout the year. We haven't guided to where we expect to go. We'll take it quarter-by-quarter, but we feel pretty confident at the 12% level as we leave March, especially considering that we've already grown from 6% to 10%. And then we do have a focus on the hospital market, obviously, as well. We'll see how that goes. But right now, very focused on community. The sales force covers 100% of that business. And today, we're feeling pretty good about it.
那麼讓我們從這裡開始吧,拉克蘭。所以我們的銷售隊伍覆蓋了整個市場。市場分為商業市場和醫院市場,340B 市場相當平均。我們主要關注社區方面的銷售人員,這些就是我們所說的共享社區。所以這是一個很大的市場。我們非常專注於此。我們預計這一份額將在全年繼續增長。我們還沒有引導到我們期望去的地方。我們將按季度進行分析,但在 3 月份結束時,我們對 12% 的水平非常有信心,尤其是考慮到我們已經從 6% 增長到 10%。顯然,我們也確實關注醫院市場。我們將看看情況如何。但是現在,非常關注社區。銷售人員負責該業務的 100%。而今天,我們對此感覺非常好。
Lachlan Hanbury-Brown - Associate
Lachlan Hanbury-Brown - Associate
Awesome. And then you mentioned in the press release and in the prepared remarks that you're anticipating growth in BARHEMSYS and BYFAVO now that the sales [wasn't fully] scaled. Can you just talk about when that sort of happened when you complete that scaling and sort of how big is it now compared to what it was last year?
驚人的。然後你在新聞稿和準備好的評論中提到,你預計 BARHEMSYS 和 BYFAVO 的增長,因為銷售 [沒有完全] 擴大。你能談談當你完成縮放時這種情況發生的時間以及與去年相比現在有多大嗎?
Scott L. Tarriff - Founder, President, CEO & Director
Scott L. Tarriff - Founder, President, CEO & Director
Yes. So the scaling is really just coming into play. We only purchased the company closed on in June. And so we went back to the territories now that we had these new products, and we made some changes. We made some expansions. At the end of the day, we have more reps today than we had last year by a few. And we're just really very excited about the ramp. It's looking good. I realize it's a small base, but you can see by the remarks we made today, there's strong growth there. We're expecting '23 to be a very solid year and lay the foundation for future growth. And we still have really high expectations. The two products are wonderful. We're getting great feedback from our customers and the users of the product. We had what I thought was a really very strong Investor Day a couple of months ago, and we just keep hearing wonderful things and let's see how the growth goes. But right now, we are also very enthusiastic about the trends for the product.
是的。所以縮放真的剛剛開始發揮作用。我們只購買了 6 月份關閉的公司。因此,既然我們有了這些新產品,我們就回到了這些地區,我們做了一些改變。我們做了一些擴展。歸根結底,我們今天的代表比去年多了幾個。我們對坡道真的很興奮。它看起來不錯。我知道這是一個小基數,但你可以從我們今天發表的言論中看出,那裡有強勁的增長。我們預計 23 年將是非常穩固的一年,並為未來的增長奠定基礎。我們仍然抱有很高的期望。這兩種產品都很棒。我們從客戶和產品用戶那裡得到了很好的反饋。幾個月前,我們舉辦了一個我認為非常強大的投資者日,我們不斷聽到精彩的消息,讓我們看看增長如何。但現在,我們也非常關注產品的趨勢。
Lachlan Hanbury-Brown - Associate
Lachlan Hanbury-Brown - Associate
And I guess on the topic of sales force, if I could just quickly ask, are you expecting much incremental expansion there around Landiolol potential approval?
我想關於銷售人員的話題,如果我可以快速問一下,您是否期望 Landiolol 的潛在批准有很大的增量擴張?
Scott L. Tarriff - Founder, President, CEO & Director
Scott L. Tarriff - Founder, President, CEO & Director
No, I think we're rightsized for all of our launches and all of our business this year. I think the step-up that we took in the people that we have now is sufficient to get us through at least the next year.
不,我認為我們今年所有的發布和我們所有的業務都是正確的。我認為我們現在所擁有的人員的提升足以讓我們至少度過明年。
Operator
Operator
Our next question comes from David Amsellem with Piper Sandler.
我們的下一個問題來自 David Amsellem 和 Piper Sandler。
David A. Amsellem - MD & Senior Research Analyst
David A. Amsellem - MD & Senior Research Analyst
So just a couple. First on vasopressin, can you just go through your thought process in more detail on the withdrawal? Is that just a function of the crowded nature of the market? Or are there other considerations? And then can you just talk to how you thought about the ROI on that given the withdrawal? And is there a potential to come back at some point as you look at market conditions? So just a few on those.
所以只是一對。首先是加壓素,你能更詳細地談談你對戒斷的思考過程嗎?這只是市場擁擠的結果嗎?還是有其他的考慮?然後你能談談你如何看待撤回的投資回報率嗎?當你觀察市場狀況時,是否有可能在某個時候回歸?所以只有一些。
And then secondly, on bendamustine, I guess it was sort of in early days with generic market formation, but can you talk about where you ultimately think things will settle out regarding both BENDEKA and BELRAPZO share? So something of a longer-term question there.
然後其次,關於苯達莫司汀,我想它在仿製藥市場形成的早期有點像,但你能談談你最終認為關於 BENDEKA 和 BELRAPZO 份額的事情會在哪裡解決嗎?所以這是一個長期的問題。
Scott L. Tarriff - Founder, President, CEO & Director
Scott L. Tarriff - Founder, President, CEO & Director
Yes. So okay, let's start with vaso, David. Thank you for the question. So look, vasopressin was the only generic we've developed in the company's history. We thought we had a unique capability to bring the product to the market and getting through the courts, which we did. We sold quite a bit last year and the year that we launched it but our business -- the rest of our business is just as strong, right? The bendamustine market, the PEMFEXY market, we're investing behind CAL02 and Enalare, there's just no real room in the company or a generic product. So we exited these generic markets well as the price declines. There's just no reason for us to be spending our time and our sales forces focus on a generic product.
是的。好吧,讓我們從 vaso 開始,大衛。感謝你的提問。所以看,加壓素是我們在公司歷史上開發的唯一仿製藥。我們認為我們有獨特的能力將產品推向市場並通過法庭,我們做到了。我們去年和推出它的那一年賣了很多東西,但我們的業務——我們其他業務也一樣強勁,對吧?苯達莫司汀市場,PEMFEXY 市場,我們投資於 CAL02 和 Enalare,公司或仿製藥沒有真正的空間。因此,隨著價格下跌,我們退出了這些仿製藥市場。我們沒有理由把時間和銷售人員都花在通用產品上。
In terms of coming back to the market, that's really very interesting. Certainly, we have the capability of doing that if things change. We did have very good market share for the product. We don't have any plans in the near future, anything that we see on the horizon, considering that we just exited, but the ANDA is viable. So we'll see how markets shake out, sometimes things change. That's basically the base story.
就重返市場而言,這真的很有趣。當然,如果情況發生變化,我們有能力這樣做。我們的產品確實有很好的市場份額。考慮到我們剛剛退出,但 ANDA 是可行的,我們在不久的將來沒有任何計劃,我們在地平線上看到的任何東西。所以我們看到市場將如何動搖,有時情況會發生變化。這基本上就是基本故事。
Now bendamustine, BENDEKA, we've guided to keeping 75% of the gross margin in '23. So far, 90 days into it -- almost 90 days into it, we're really encouraged. We're ahead of our forecast and our plans. I think that speaks well to the strength of the benefits of the products.
現在苯達莫司汀,BENDEKA,我們已經指導在 23 年保持 75% 的毛利率。到目前為止,已經 90 天了——將近 90 天了,我們真的很受鼓舞。我們領先於我們的預測和計劃。我認為這很好地說明了產品優勢的強度。
Let's see how the months go, we'll give more of an update when we close out Q1 when we report there. But I mean, so far, we're thrilled about how the products are holding up and how the trends are working. And right now, again, we just feel great about bendamustine and, quite frankly, the entire line. So let's see how things unfold. It's going to be another really good strong year for us in '23.
讓我們看看這幾個月過得怎麼樣,當我們在那里報告時關閉第一季度時,我們會提供更多更新。但我的意思是,到目前為止,我們對產品的表現以及趨勢的運作方式感到非常興奮。而現在,再次,我們對苯達莫司汀感覺很好,坦率地說,整個系列。那麼讓我們看看事情是如何展開的。對我們來說,23 年將是又一個非常強勁的一年。
Operator
Operator
At this time, I show no further questions in queue. I'll turn the call back to Scott Tarriff for any additional or closing remarks.
此時,我不會在隊列中顯示更多問題。我會把電話轉回 Scott Tarriff 以徵求任何補充意見或結束意見。
Scott L. Tarriff - Founder, President, CEO & Director
Scott L. Tarriff - Founder, President, CEO & Director
Well, thank you, everybody, for joining the call. '22 is a record year for Eagle, and we're committed to carrying that momentum into '23 and beyond. Our team remains focused on delivering value to stakeholders and ensuring that patients have access to our therapeutics. We look forward to updating you as we continue to pursue growth organically and potentially through acquisitions. Thanks everybody for joining today. I appreciate it. And be healthy.
嗯,謝謝大家加入電話會議。 22 年對 Eagle 來說是創紀錄的一年,我們致力於將這種勢頭帶入 23 年及以後。我們的團隊仍然專注於為利益相關者提供價值,並確保患者能夠獲得我們的療法。我們期待著為您提供最新信息,因為我們將繼續追求有機增長並可能通過收購實現增長。感謝大家今天的加入。我很感激。保持健康。
Operator
Operator
This concludes today's call. Thank you for your participation. You may disconnect at any time.
今天的電話會議到此結束。感謝您的參與。您可以隨時斷開連接。