ANI Pharmaceuticals Inc (ANIP) 2022 Q4 法說會逐字稿

Good morning, everyone, and my name is Ashley, and I'll be your conference operator. At this time, I'd like to welcome everyone to ANI Pharmaceuticals' Fourth Quarter and Full Year 2022 financial results.

各位早上好，我叫 Ashley，我將擔任你們的會議接線員。此時，我想歡迎大家閱讀 ANI Pharmaceuticals 的第四季度和 2022 年全年財務業績。

(Operator Instructions)

（操作員說明）

As a reminder, this conference call is being recorded today, March 9, 2023. It is now my pleasure to turn the floor over to Ms. Judy DiClemente, Investor Relations for ANI Pharmaceuticals. Please go ahead.

提醒一下，本次電話會議將於今天（2023 年 3 月 9 日）進行錄製。現在我很高興將發言權交給 ANI Pharmaceuticals 投資者關係部的 Judy DiClemente 女士。請繼續。

Thank you, Ashley. Welcome to ANI Pharmaceuticals' Q4 2022 Earnings Results Call. This is Judy DiClemente of Insight Communications, Investor Relations for ANI. With me on today's call are Nikhil Lalwani, President and Chief Executive Officer; and Stephen Carey, Chief Financial Officer of ANI. You can also access the webcast of this call through the Investors section of the ANI website at www.anipharmaceuticals.com.

謝謝你，艾希禮。歡迎來到 ANI Pharmaceuticals 的 2022 年第四季度收益結果電話會議。我是 ANI 投資者關係 Insight Communications 的 Judy DiClemente。與我一起參加今天電話會議的有總裁兼首席執行官 Nikhil Lalwani； ANI 首席財務官 Stephen Carey。您還可以通過 ANI 網站 www.anipharmaceuticals.com 的投資者部分訪問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 ANI Pharmaceuticals management as of today and involve risks and uncertainties, including those noted in our press release issued this morning and our filings with the SEC. Such forward-looking statements are not guarantees of future performance. Actual results may differ materially from those projected in the forward-looking statements.

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 ANI Pharmaceuticals 管理層截至今日可獲得的信息，涉及風險和不確定性，包括我們今天上午發布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風險和不確定性。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。

ANI specifically disclaims any intent or obligation to update these forward-looking statements, except as required by law. The archived webcast will be available for 30 days on our website, anipharmaceuticals.com. For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on March 9, 2023. Since then, ANI may have made announcements related to the topics discussed, so please reference the company's most recent press releases and SEC filings.

除非法律要求，否則 ANI 明確否認有任何更新這些前瞻性陳述的意圖或義務。存檔的網絡廣播將在我們的網站 anipharmaceuticals.com 上提供 30 天。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 9 日舉行並錄製。此後，ANI 可能發布了與所討論主題相關的公告，因此請參考公司最近的新聞發布和 SEC 文件。

And with that, I'll turn the call over to Nikhil Lalwani. Nikhil?

有了這個，我會把電話轉給 Nikhil Lalwani。尼克爾？

Thank you, Judy. Good morning, everyone, and thank you for joining our call. 2022 was a landmark year for ANI, taking us past critical inflection points for our 2 critical growth drivers. Our Rare Disease business with the successful launch of our foundational asset, Purified Cortrophin Gel and our Generics business to the acquisition and integration of Novitium, a best-in-class generics R&D organization. The significant achievements of 2022 further strengthen ANI to deliver sustainable, competitive and profitable growth. We keep the patient at the center of everything we do and remain deeply committed to providing high-quality medicines to patients in need.

謝謝你，朱迪。大家早上好，感謝您加入我們的電話會議。 2022 年對 ANI 來說是具有里程碑意義的一年，使我們跨越了兩個關鍵增長動力的關鍵拐點。我們的罕見病業務成功推出了我們的基礎資產 Purified Cortrophin Gel 和我們的仿製藥業務，以收購和整合一流的仿製藥研發機構 Novitium。 2022 年取得的重大成就進一步加強了 ANI 以實現可持續、有競爭力和盈利的增長。我們將患者置於我們所做一切的中心，並始終堅定地致力於為有需要的患者提供高質量的藥物。

I'm proud to report that for the full year 2022, ANI revenues totaled $316.4 million, surpassing the $300 million mark for the first time in the company's history. This was an increase of over $100 million and 46% year-over-year. In the fourth quarter, revenues grew by nearly 55% to $94.2 million, a company record for quarterly revenues. We delivered remarkable growth in adjusted non-GAAP EBITDA from $4.3 million in the first quarter of 2022 to $23.3 million in the fourth quarter.

我很自豪地報告，2022 年全年，ANI 的收入總計 3.164 億美元，在公司歷史上首次超過 3 億美元大關。這比去年同期增加了 1 億多美元和 46%。第四季度，收入增長近 55%，達到 9420 萬美元，創下公司季度收入記錄。我們實現了調整後的非公認會計準則 EBITDA 的顯著增長，從 2022 年第一季度的 430 萬美元增至第四季度的 2330 萬美元。

Let me now turn to the 2 strategic imperatives that we need to remain focused on to drive sustainable, profitable and competitive growth in 2023 and beyond. The first imperative is scaling up our Rare Disease business. Our foundational asset, Purified Cortrophin Gel has experienced great momentum through the first year of launch. As you would expect, we made tweaks in our strategy as the launch unfolded. We are pleased to report that the fourth quarter sales totaled $17.6 million, and for our first year of launch, total sales were $41.7 million. Importantly, according to IQVIA, the ACTH class of therapy has gone from consistent year-on-year declines to year-over-year unit growth for the first time since 2019.

現在讓我談談我們需要繼續關注的兩項戰略要務，以推動 2023 年及以後的可持續、盈利和有競爭力的增長。當務之急是擴大我們的罕見病業務。我們的基礎資產 Purified Cortrophin Gel 在推出的第一年經歷了巨大的發展勢頭。如您所料，隨著發布的展開，我們對策略進行了調整。我們很高興地報告第四季度銷售額總計 1760 萬美元，而在我們推出的第一年，總銷售額為 4170 萬美元。重要的是，根據 IQVIA 的數據，ACTH 類療法自 2019 年以來首次從同比下降轉為單位同比增長。

From June 2022 to January 2023, the ACTH category has seen 8 consecutive months of year-on-year growth. As of March 8, cumulative new patient cases initiated increased to more than 1,120 with more than 510 unique prescribers. We are pleased that we have continued to see growth in the number of new unique prescribers and an increasing number of healthcare providers becoming repeat prescribers. Overall, we have seen prescriber interest in having an alternate treatment in the ACTH category continue to build.

從2022年6月到2023年1月，ACTH類別連續8個月同比增長。截至 3 月 8 日，累計新發病例增加到 1,120 多例，有 510 多位獨立處方醫生。我們很高興我們繼續看到新的獨特處方者數量的增長以及越來越多的醫療保健提供者成為重複處方者。總的來說，我們已經看到開處方者對 ACTH 類別中的替代治療的興趣繼續增加。

Many of our prescribers had previously slowed or discontinued use of the ACTH class and have restarted their use of ACTH therapy after the launch of Purified Cortrophin Gel. Prescriptions continue to be distributed across our targeted specialties, which includes certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis in rheumatoid arthritis and excess urinary protein given the nephrotic syndrome. We have actively participated in the key national and regional medical conferences and have also initiated peer-to-peer programs across these specialties to educate physicians, to increase awareness and understanding of Cortrophin Gel.

我們的許多開處方者之前已經減慢或停止使用 ACTH 類，並在 Purified Cortrophin Gel 推出後重新開始使用 ACTH 療法。處方繼續分佈在我們的目標專業，其中包括某些慢性自身免疫性疾病，包括類風濕性關節炎多發性硬化症的急性加重和腎病綜合徵引起的尿蛋白過多。我們積極參加了重要的國家和地區醫學會議，並發起了跨這些專業的同行項目來教育醫生，提高對 Cortrophin Gel 的認識和理解。

Our peer-to-peer education programs have been well received with positive early feedback. We have invested and are continuing our efforts with the PBMs and payers across commercial, Medicaid and Medicare to expand market access for Cortrophin for the appropriate patients in need. In addition, we have further strengthened our patient services and reimbursement teams to support access to Cortrophin Gel and reduce the time taken from enrollment to fulfillment. In parallel, we have taken several initiatives to increase the effectiveness of our highly experienced sales force. In 2023, we will augment these efforts with enhanced data to improve prescriber targeting. With the momentum from our launch, we will also commence modest expansion of our sales force to focus on pulmonology.

我們的點對點教育計劃深受好評，並獲得了積極的早期反饋。我們已經投資並繼續與商業、醫療補助和醫療保險的 PBM 和付款人合作，為有需要的適當患者擴大 Cortrophin 的市場准入。此外，我們進一步加強了我們的患者服務和報銷團隊，以支持獲得 Cortrophin Gel 並減少從註冊到履行所需的時間。與此同時，我們採取了多項舉措來提高我們經驗豐富的銷售團隊的效率。 2023 年，我們將通過增強數據來加強這些努力，以改善開處方者的針對性。憑藉推出後的勢頭，我們還將開始適度擴大銷售隊伍，專注於肺病學。

Looking ahead, and as Steve will discuss shortly in more detail, we expect 2023 revenue from Cortrophin Gel to be in the $80 million to a $90 million range, and the Cortrophin SGA increase to be estimated at approximately 10%. We believe that ANI has built a Rare Disease platform successfully encompassing medical affairs, patient support, market access and specialty pharmacy distribution. The success of our foundational asset, Purified Cortrophin Gel has given the company confidence and we are actively exploring assets to acquire or partner on to leverage the platform and scale of the Rare Disease business.

展望未來，正如史蒂夫將在短期內更詳細地討論的那樣，我們預計 2023 年來自 Cortrophin Gel 的收入將在 8000 萬美元至 9000 萬美元之間，而 Cortrophin SGA 的增長估計約為 10%。我們相信 ANI 已經成功地建立了一個涵蓋醫療事務、患者支持、市場准入和專業藥房分銷的罕見病平台。我們的基礎資產 Purified Cortrophin Gel 的成功給了公司信心，我們正在積極探索收購或合作的資產，以利用罕見疾病業務的平台和規模。

Before I move on to our Generics business, I would like to share an important point. During the early days of the launch, we believe it was important to share detailed metrics to give investors insight into the dynamics of and progress of our launch. As the Cortrophin launched has gathered momentum, and investors have gained further confidence, we have decided to pare back sharing competitively sensitive detailed metrics such as number of prescribers and patient cases initiated.

在我繼續我們的仿製藥業務之前，我想分享一個重要的觀點。在發布的早期，我們認為分享詳細的指標非常重要，可以讓投資者深入了解我們發布的動態和進展。隨著 Cortrophin 推出的勢頭越來越大，投資者也獲得了進一步的信心，我們決定減少分享競爭敏感的詳細指標，例如開處方者的數量和發起的患者病例。

Moving now to our second strategic imperative, driving Generic business growth to superior new product launch execution, cost excellence and supply reliability. Sales of our generic pharmaceutical products grew 46% year-on-year. We launched several limited-competition new generics and retained a top 10 ranking in terms of ANDA approvals. In addition, ANI continues to retain the second ranking for competitive generic therapy approvals. This is especially impressive given the scale of our Generics business and a large number of companies that compete in the U.S. Generics market. In 2022, we filed 12 ANDAs and expect to continue investing in generics R&D to support our growth aspirations.

現在轉向我們的第二個戰略要務，推動通用業務增長，以實現卓越的新產品發布執行、卓越的成本和供應可靠性。我們的仿製藥產品銷售額同比增長 46%。我們推出了多個競爭有限的新仿製藥，並在 ANDA 批准方面保持了前 10 名的排名。此外，ANI 繼續保持競爭性仿製藥批准的第二名。考慮到我們仿製藥業務的規模以及在美國仿製藥市場競爭的眾多公司，這一點尤其令人印象深刻。 2022 年，我們提交了 12 項 ANDA，並期望繼續投資於仿製藥研發，以支持我們的增長願望。

We are also making large strides in the area of cost excellence. The consolidation of our manufacturing network is on track. Manufacturing operations speed at the Oakville Ontario site in January 2023 and the relocation of Oakville products to U.S. facilities have been completed. We are in active discussions with potential buyers for the Oakville site. And once fully executed, this operational efficiency is expected to improve GAAP profitability and cash flow by $7 million to $8 million on an annualized basis.

我們還在卓越成本領域取得了長足進步。我們的製造網絡整合正在按計劃進行。 2023 年 1 月，安大略省奧克維爾工廠的製造運營速度加快，奧克維爾產品向美國工廠的搬遷工作已經完成。我們正在與 Oakville 場地的潛在買家進行積極討論。一旦完全執行，這種運營效率預計將按年度計算將 GAAP 盈利能力和現金流提高 700 萬至 800 萬美元。

Looking ahead, we have augmented our analytical and development -- sorry, our analytical and development facility in Chennai, India. The facility completed a successful FDA audit with the FDA in 2022. And today, over 60 skilled colleagues at the facility contribute materially to ANI's efforts to serving patients in need. Over the years, ANI has built a strong reputation as a reliable supplier to patients and customers. We have invested in maintaining healthy inventory levels, both for materials and finished goods. All of our manufacturing facilities are in the U.S. and our domestic supply chain further enhances our reliability as a supplier.

展望未來，我們已經擴大了我們的分析和開發——抱歉，我們在印度金奈的分析和開發設施。該設施於 2022 年成功完成了 FDA 的 FDA 審計。今天，該設施的 60 多名技術嫻熟的同事為 ANI 為有需要的患者提供服務做出了重大貢獻。多年來，ANI 作為患者和客戶的可靠供應商建立了良好的聲譽。我們已投資維持健康的庫存水平，包括材料和成品。我們所有的製造工廠都在美國，我們的國內供應鏈進一步提高了我們作為供應商的可靠性。

Finally, the strong compliance and audit history across our facilities exemplifies our efforts to deliver high-quality medicines. Most recently, during the fourth quarter, the FDA conducted a routine good manufacturing practices audit at our facility in Baudette, Minnesota. We have implemented all corrective and preventive actions needed and we have already received a favorable establishment inspection report or EIR, classifying that our Baudette facility is Voluntary Action Indicated, VAI. I am proud of the dedicated work of our employees and our Generics business with over 20 million prescriptions filled using ANI medicines.

最後，我們設施中強大的合規性和審計歷史證明了我們為提供高質量藥品所做的努力。最近，在第四季度，FDA 在我們位於明尼蘇達州 Baudette 的工廠進行了例行的良好生產規範審計。我們已經實施了所有必要的糾正和預防措施，並且我們已經收到了有利的企業檢查報告或 EIR，將我們的 Baudette 工廠歸類為自願行動指示 (VAI)。我為我們的員工和我們的仿製藥業務的敬業工作感到自豪，超過 2000 萬張處方使用 ANI 藥物配製。

In summary, 2022 was a landmark deal for ANI, taking us past a critical inflection points for the key driver of ANI's growth, scaling up our Rare Disease business. In 2023, we look forward to building on the launch momentum of Cortrophin Gel and acquiring or partnering on other assets that leverage our Rare Disease platform. Steve will now walk through our detailed fourth quarter financial results and discuss our guidance for the coming year. Steve?

總而言之，2022 年對 ANI 來說是一項具有里程碑意義的交易，使我們度過了 ANI 增長的主要驅動力的關鍵轉折點，擴大了我們的罕見病業務。 2023 年，我們期待在 Cortrophin Gel 的推出勢頭的基礎上，收購或合作利用我們的罕見疾病平台的其他資產。史蒂夫現在將詳細介紹我們第四季度的詳細財務業績，並討論我們對來年的指導。史蒂夫？

Thank you, Nikhil, and good morning to everyone on the call. My comments this morning will be focused on the 3 months ended December 31, 2022 versus the prior year, unless otherwise noted. First off, as Nikhil indicated, 2022 has been a transformational year as we successfully operationalized the Purified Cortrophin Gel launch and integrated the November 2021 acquisition of Novitium into our overall operation. These 2 platforms for growth drove ANI's full year revenue to $316.4 million, marking the first time in ANI's history that our full year revenue has surpassed $300 million. This represents $100 million or 46% growth over the $216.1 million reported in 2021 and establishes a new base as the company continues its growth trajectory. This full year achievement was built upon strong sequential quarterly growth accumulating in $94.2 million of revenues for the 3 months ending December 31, 2022, up $33.3 million or 54.7% as compared to the prior year period, driven by strong gains in both of our operating segments.

謝謝你，Nikhil，早上好。除非另有說明，否則我今天上午的評論將集中在截至 2022 年 12 月 31 日的 3 個月與上一年的對比上。首先，正如 Nikhil 所指出的，2022 年是轉型的一年，因為我們成功推出了 Purified Cortrophin Gel，並將 2021 年 11 月對 Novitium 的收購整合到了我們的整體運營中。這兩個增長平台推動 ANI 的全年收入達到 3.164 億美元，這是 ANI 歷史上全年收入首次超過 3 億美元。這比 2021 年報告的 2.161 億美元增長了 1 億美元或 46%，並隨著公司繼續其增長軌跡建立了新的基礎。這一全年成就是建立在強勁的連續季度增長基礎上的，截至 2022 年 12 月 31 日的 3 個月收入累計達到 9420 萬美元，比上年同期增長 3330 萬美元或 54.7%，這主要得益於我們的兩個運營業務的強勁增長段。

Revenues from Purified Cortrophin Gel led the way with $17.6 million in revenues in the quarter. Revenues of our Generics established brands and other segments were up $15.7 million or 25.8% over the prior year, driven by gains in our generic pharmaceutical product line, which was up $16.4 million or 39% year-over-year. This increase was principally driven by revenues from multiple 2022 new product launches and partially tempered by an increase in revenues from sales of several legacy ANI generic products. Contract manufacturing revenues were $4 million during the fourth quarter of 2022, up 45.9% from the $2.8 million posted in the prior year period, primarily related to the addition of Novitium contract manufacturing revenues.

Purified Cortrophin Gel 的收入在本季度以 1760 萬美元的收入位居榜首。我們的仿製藥品牌和其他細分市場的收入比上一年增長了 1570 萬美元或 25.8%，這得益於我們的仿製藥產品線的收益，該產品線同比增長 1640 萬美元或 39%。這一增長主要是由 2022 年多項新產品發布帶來的收入推動的，部分受到幾款遺留 ANI 仿製藥銷售收入增加的影響。 2022 年第四季度合同製造收入為 400 萬美元，比去年同期的 280 萬美元增長 45.9%，這主要與 Novitium 合同製造收入的增加有關。

Royalty and other revenues were $1.9 million in the current year quarter in line with prior year levels. Tempering these growth drivers were net revenues for established brand pharmaceutical products at $12.7 million during the 3 months ended December 31, 2022. This represents a decrease of 13.3% compared to the $14.7 million for the same period in 2022, driven by lower aggregate unit volumes across the portfolio.

本年度季度的特許權使用費和其他收入為 190 萬美元，與去年同期水平持平。截至 2022 年 12 月 31 日的三個月內，知名品牌醫藥產品的淨收入為 1,270 萬美元，這與 2022 年同期的 1,470 萬美元相比下降了 13.3%，原因是總單位銷量下降整個投資組合。

Operating expenses increased by approximately 9.2% to $92.4 million for the 3 months ended December 31, 2022, from $84.7 million in the prior year period. Cost of sales, excluding depreciation and amortization, increased by $2.4 million to $36.3 million in the fourth quarter of 2022 compared to $33.9 million in the prior year period, primarily due to increased sales volumes of generic products and sales of Purified Cortrophin Gel. Excluding the impact of acquisition accounting, stock compensation and the effects of our Oakville Ontario plant closure, all of which are detailed in the tables contained in this morning's press release.

截至 2022 年 12 月 31 日的三個月，運營費用從去年同期的 8470 萬美元增加了約 9.2% 至 9240 萬美元。與去年同期的 3390 萬美元相比，2022 年第四季度的銷售成本（不包括折舊和攤銷）增加了 240 萬美元，達到 3630 萬美元，這主要是由於仿製藥銷量和 Purified Cortrophin Gel 銷量的增加。不包括收購會計、股票補償和我們安大略省奧克維爾工廠關閉的影響，所有這些都在今天上午的新聞稿中的表格中進行了詳細說明。

Cost of sales on a non-GAAP basis as a percentage of total net revenues decreased 7.3 points from 45.7% in the fourth quarter of 2021 to 38.4% in the current year period, primarily as a result of favorable mix from the impact of sales of Purified Cortrophin Gel coupled with the impact of new product launches in our Generic franchise. These favorable impacts were partially offset by lower sales of established brand products in the period.

按非美國通用會計準則計算的銷售成本占淨收入總額的百分比從 2021 年第四季度的 45.7% 下降 7.3 個百分點至本年度的 38.4%，這主要是由於銷售的影響帶來的有利組合純化的 Cortrophin 凝膠加上新產品發布對我們的仿製藥特許經營的影響。這些有利影響被該期間知名品牌產品的銷售額下降部分抵消。

Research and development expenses were $5.2 million in the fourth quarter of 2022, an increase of $2.1 million from prior year, primarily due to expenses related to an increased level of generic research and development activities during the current year period. Selling, general and administrative expenses increased by 8.1% to $33.2 million in the fourth quarter of 2022 compared to $30.7 million in the prior year quarter, primarily due to a $3.9 million increase in sales and marketing expenses related to our launch of Purified Cortrophin Gel, a full quarter's worth of Novitium headcount and activities as compared to a partial quarter in the prior year and increased infrastructure to support the growth in our business. These effects were partially offset by a $4.3 million decrease in transaction expenses related to the Novitium acquisition. Depreciation and amortization expense was $14.5 million for the 3 months ended December 31, 2022, compared to $13.7 million for the same period in 2021, an increase of $0.8 million, primarily due to the amortization of intangible assets acquired in the Novitium acquisition.

2022 年第四季度的研發費用為 520 萬美元，比上年增加 210 萬美元，這主要是由於與本年度仿製藥研發活動水平增加相關的費用。與去年同期的 3070 萬美元相比，2022 年第四季度的銷售、一般和管理費用增加了 8.1%，達到 3320 萬美元，這主要是由於與我們推出 Purified Cortrophin Gel 相關的銷售和營銷費用增加了 390 萬美元，與上一年的部分季度相比，整個季度的 Novitium 員工人數和活動價值，以及增加的基礎設施以支持我們業務的增長。這些影響被與收購 Novitium 相關的交易費用減少 430 萬美元部分抵消。截至 2022 年 12 月 31 日止三個月的折舊和攤銷費用為 1450 萬美元，與 2021 年同期的 1370 萬美元相比增加了 80 萬美元，這主要是由於對 Novitium 收購中獲得的無形資產進行了攤銷。

We recognized $1.6 million of restructuring expense in the fourth quarter of 2022 associated with the closure of our Oakville, Ontario facility. Costs included $0.3 million in termination benefits and $1.1 million in fixed asset accelerated depreciation. No restructuring activities were recognized in the prior year period. We have excluded both the onetime charges resulting from this action as well as the portions of the Canada results that are expected to be nonrecurring post closure from our non-GAAP financial measures as detailed in the tables in this morning's press release.

我們在 2022 年第四季度確認了與安大略省奧克維爾工廠關閉相關的 160 萬美元重組費用。成本包括 30 萬美元的離職福利和 110 萬美元的固定資產加速折舊。上一年期間沒有確認重組活動。正如今天上午的新聞稿中的表格所詳述的那樣，我們已從我們的非 GAAP 財務指標中排除了由此行動產生的一次性費用以及預計在關閉後不會經常出現的加拿大業績部分。

During the quarter ended December 31, 2022, we also recognized the noncash fair value adjustment of $1.6 million related to the contingent consideration recorded in conjunction with Novitium purchase accounting. Our $0.28 GAAP net loss per share for the quarter reflects significant amortization and purchase accounting-related charges from the Novitium acquisition coupled with the sales and marketing expense behind our initial commercial launch of Cortrophin and Oakville-related restructuring activities.

在截至 2022 年 12 月 31 日的季度中，我們還確認了 160 萬美元的非現金公允價值調整，該調整與結合 Novitium 採購會計記錄的或有對價相關。我們本季度每股 0.28 美元的 GAAP 淨虧損反映了 Novitium 收購的重大攤銷和採購會計相關費用，以及我們最初商業推出 Cortrophin 和 Oakville 相關重組活動背後的銷售和營銷費用。

On an adjusted non-GAAP basis, we had diluted earnings per share of $0.76 for the quarter compared to $0.06 in the prior year period. Adjusted non-GAAP EBITDA for the fourth quarter of 2022 of $23.3 million, more than tripled as compared to the $7.2 million posted in the fourth quarter of 2021. And on a sequential basis, was up $4.9 million from $18.4 million in the third quarter of this year. Also, please note, as disclosed in the footnote to Tables 3 and 4 to this morning's press release, beginning in the fourth quarter of 2022, ANI no longer excludes expense for in-process research and development, Cortrophin prelaunch charges and Cortrophin sales and marketing expenses from its non-GAAP results. Historically, the company excluded these charges. These changes have been made to align with views expressed by the U.S. Securities and Exchange Commission. Prior periods have been recast to reflect these changes.

在調整後的非 GAAP 基礎上，我們本季度的每股攤薄收益為 0.76 美元，而去年同期為 0.06 美元。 2022 年第四季度調整後的非美國通用會計準則 EBITDA 為 2330 萬美元，比 2021 年第四季度的 720 萬美元增長了兩倍多。按順序計算，比 2021 年第三季度的 1840 萬美元增加了 490 萬美元今年。此外，請注意，正如今天上午新聞稿表 3 和表 4 的腳註中所披露的那樣，從 2022 年第四季度開始，ANI 不再排除進行中研發、Cortrophin 上市前費用以及 Cortrophin 銷售和營銷的費用其非 GAAP 業績的費用。從歷史上看，該公司不包括這些費用。做出這些更改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。

From a balance sheet perspective, we exited the year with $48.2 million in unrestricted cash and cash equivalents and $297 million in face value of outstanding debt which is due in November of 2027. As expected, full year 2022 was a heavy cash utilization year with $31.2 million of cash used in operations as we invested behind the Rare Disease platform and had significant build of working capital due to rapidly accelerating sequential net revenues.

從資產負債表的角度來看，我們以 4820 萬美元的無限制現金和現金等價物以及 2.97 億美元的面值 2027 年 11 月到期的未償債務結束了這一年。正如預期的那樣，2022 年全年是現金使用率高的一年，為 31.2 美元百萬現金用於運營，因為我們投資於罕見疾病平台，並且由於快速加速的連續淨收入而擁有大量營運資金。

Finally, with this morning's press release, we are instituting 2023 guidance. Total company net revenue between $360 million and $385 million, representing approximately at least 14% to 22% growth as compared to $316.4 million recognized in 2022. Cortrophin specific revenue guidance of between $80 million to $90 million, representing 92% to 116% growth as compared to $41.7 million recognized in 2022. Total company non-GAAP gross margin between 59.5% and 61%. Total company adjusted non-GAAP EBITDA between $78 million and $88 million and adjusted non-GAAP diluted earnings per share between $2.09 and $2.59. In addition, we currently anticipate between 16.8 million and 17.1 million shares outstanding and an effective tax rate of approximately 24% prior to any federal tax reform.

最後，在今天上午的新聞稿中，我們正在製定 2023 年指南。公司淨收入總額在 3.6 億美元至 3.85 億美元之間，與 2022 年確認的 3.164 億美元相比至少增長了約 14% 至 22%。Cortrophin 的具體收入指導在 8000 萬至 9000 萬美元之間，增長了 92% 至 116%與 2022 年確認的 4170 萬美元相比。公司非 GAAP 總毛利率在 59.5% 至 61% 之間。公司調整後的非 GAAP EBITDA 總額在 7800 萬美元至 8800 萬美元之間，調整後的非 GAAP 攤薄每股收益在 2.09 美元至 2.59 美元之間。此外，我們目前預計在進行任何联邦稅制改革之前，流通股將在 1680 萬至 1710 萬股之間，有效稅率約為 24%。

We will now open up the call to questions. Operator, please announce the instruction.

我們現在將開始提問。接線員，請宣布指令。

(Operator Instructions)

（操作員說明）

And we will take our first question from Elliot Wilbur with Raymond James.

我們將與 Raymond James 一起回答 Elliot Wilbur 的第一個問題。

First question for Nikhil and Steve as well, I guess. Just thinking about expectations with respect to the base business, generics legacy brands, backing out the numbers, it looks like you're expecting growth in mid-to-high single digits. And just wondering what the assumptions are as far as new approvals, new launches, should we be expecting a similar pattern to what we've seen over the past 12 months where we kind of see a steady cadence of smaller products coming out of the legacy Novitium pipeline? And is there anything that you could offer up in terms of visibility around any date certain or larger launch opportunities that might enhance confidence in your modest growth expectations for that component of the business?

我想，第一個問題也是針對 Nikhil 和 Steve 的。僅考慮對基礎業務、仿製藥傳統品牌的期望，退回數字，您似乎期望中高個位數的增長。只是想知道關於新批准、新發布的假設是什麼，我們是否應該期待與我們在過去 12 個月中看到的類似模式，在過去 12 個月中，我們看到傳統的小型產品的穩定節奏Novitium管道？在任何日期特定或更大的發布機會的可見性方面，您是否可以提供任何可以增強您對該業務部分適度增長預期的信心的東西？

Sure. Thank you, Elliot, and good morning. Look, I think the 2023 launch cadence will be similar to 2022, as you used the words -- a steady stream of launches. I think that over time, the scale of those steady stream of launches will increase. But to the other part of your question, there isn't a date certain or a large launch to sort of point to -- there are some sort of relatively larger launches, but nothing that stands out as a substantially larger than everything else and in terms of concentration of new product launch revenues, we currently don't see that. But that's not factored into as an assumption into our guidance for the base business or our overhead and our overall guidance.

當然。謝謝你，埃利奧特，早上好。看，我認為 2023 年的發布節奏將與 2022 年相似，正如您所說的那樣——源源不斷的發布。我認為隨著時間的推移，這些穩定的發射流的規模將會增加。但對於你問題的另一部分，沒有確定的日期或大型發射可以指出——有一些相對較大的發射，但沒有什麼比其他任何東西都大得多，而且在就新產品發布收入的集中度而言，我們目前看不到這一點。但這並沒有作為我們對基本業務的指導或我們的間接費用和我們的整體指導的假設。

Yes. The other thing I would add, Nikhil and Elliot, as we look and unpack the different elements that roll up into that segment, I would say we're expecting the growth in that segment to be led by the Generic platform and declined year-over-year in the established brands side of the business and the contract manufacturing side of the business. So there's a little bit of mix rolling up into that segment observation that you made.

是的。我要補充的另一件事是，Nikhil 和 Elliot，當我們審視並分析匯總到該細分市場的不同元素時，我想說的是，我們預計該細分市場的增長將由 Generic 平台引領，並且同比下降-年在業務的知名品牌方面和業務的合同製造方面。因此，您所做的細分觀察中有一些混合。

Okay. And maybe just a couple of quick financial questions for your sales. Steve, just anything specifically you can or want to say about the kind of -- it looks like the implied step-up in SG&A and R&D spend, so most of that is targeted to the expansion of Cortrophin call activities, but anything else that you can say there in terms of more specifics would be helpful. And then you referenced working capital investment over the course of 2022, looking at your adjusted net income expectations based on some of the outlook items that you've offered, I mean it looks like you guys are looking for around $40 million to $45 million in adjusted net income. Anything you could say with respect to anticipated cash conversion ratio there? I'm guessing maybe you would expect to actually overperform more than 100% cash conversion, but I just wanted to bounce that off you and see if there's anything you can give us in terms of expected cash conversion, operating cash flow generation in 2023?

好的。也許只是一些針對您的銷售的快速財務問題。史蒂夫，關於那種你可以或想說的任何特別的事情——看起來像是隱含的 SG&A 和研發支出的增加，所以大部分都是針對 Cortrophin 呼叫活動的擴展，但你想說的任何其他事情可以說在更具體的方面會有幫助。然後你參考了 2022 年的營運資本投資，根據你提供的一些前景項目查看調整後的淨收入預期，我的意思是看起來你們正在尋找大約 4000 萬到 4500 萬美元的投資調整後的淨收入。關於那裡的預期現金轉換率，您有什麼要說的嗎？我猜你可能期望實際上超過 100% 的現金轉換，但我只是想反駁你，看看你是否可以在 2023 年的預期現金轉換、運營現金流產生方面給我們什麼？

Sure. Yes, sure thing. Yes. And while we're not offering specific SG&A and R&D guidance this morning, obviously, the implication and the reality is that both of those line items will be growing year-over-year. On the R&D side, it will be continued investment and an increased investment in the R&D platform, principally on the Generic side. Obviously, the company has made a very significant investment in the Novitium platform, one that we're extremely happy with. And you can see the clear impact of the performance of the Novitium platform in 2022. And so, right, we're focused on continuing to build and expand upon that platform.

當然。是的，當然。是的。雖然我們今天早上沒有提供具體的 SG&A 和 R&D 指導，但顯然，這兩個項目的含義和現實情況都將同比增長。在研發方面，將繼續投資並增加對研發平台的投資，主要是在仿製藥方面。顯然，該公司對 Novitium 平台進行了非常大的投資，我們對此非常滿意。您可以看到 2022 年 Novitium 平台性能的明顯影響。因此，我們專注於繼續構建和擴展該平台。

And then on the SG&A side, right, a touch driven by continued investment in the Rare Disease platform and year 2 of the Purified Cortrophin Gel launch as Nikhil had indicated in his prepared statements, we see that direct investment in Rare Disease, SG&A around a 10% increase year-over-year. And then the other aspects of SG&A, right, or just as the company is growing, right, at such a fast clip, obviously, the support structure, the supporting functions naturally grow around that growth in the business in order to adequately support the company and its objectives. And so that's something that's been happening throughout the course of 2022. And so there's -- you kind of start off the year with an annualization effect of bills and decisions that were made in 2022 and then a touch more layered in as we envision continued growth across our 2 growth platforms.

然後在 SG&A 方面，正確的是，正如 Nikhil 在他準備好的聲明中所指出的那樣，對罕見疾病平台的持續投資和 Purified Cortrophin Gel 發布的第 2 年推動了觸動，我們看到對罕見疾病、SG&A 的直接投資圍繞同比增長 10%。然後是 SG&A 的其他方面，對，或者隨著公司的發展，對的，以如此快的速度，顯然，支持結構，支持功能自然會圍繞業務增長而增長，以便充分支持公司及其目標。因此，這就是整個 2022 年一直在發生的事情。因此，您可以從 2022 年制定的法案和決策的年化效應開始，然後隨著我們設想的持續增長而更加分層在我們的 2 個增長平台上。

On the topic of cash, yes, as we look forward to 2023, we definitely envision getting back to positive cash flows. The cash flows in 2022, were expected to be cash-use year as we stood up the Rare Disease business, right? If you unpack the performance on a quarterly basis in -- again, in 2022, right, as you have the rare disease and machinery up and running essentially from day 1, January 1, 2022, yet you have all sequential revenues, right, going from $1 million in the first quarter to over $17 million in the fourth. So that's a very significant effect in terms of cash use and then as Cortrophin reaches breakeven. And as we look forward to 2023, we very much anticipate returning to favorable cash flows on a total company basis. I'm not going to specify versus your assumed $45 million of operational. But I would tell you, we do expect reasonably strong cash flows in 2023 and then building off of that base.

關於現金，是的，當我們期待 2023 年時，我們肯定會設想恢復正現金流。 2022 年的現金流預計將是現金使用年，因為我們建立了罕見病業務，對嗎？如果你按季度對業績進行分析——再次，在 2022 年，對，因為你有罕見的疾病和機器基本上從 2022 年 1 月 1 日的第一天開始運行，但你有所有連續的收入，對的，去從第一季度的 100 萬美元增加到第四季度的超過 1700 萬美元。因此，就現金使用而言，這是一個非常顯著的影響，然後隨著 Cortrophin 達到收支平衡。展望 2023 年，我們非常期待在整個公司的基礎上恢復有利的現金流。我不會具體說明與您假設的 4500 萬美元的運營成本。但我會告訴你，我們確實預計 2023 年會有相當強勁的現金流，然後在此基礎上建立。

Okay. And just 1 last question around Cortrophin. Nikhil, is the expansion of the sales force specifically targeted towards the pulmonologist community or what also enable you to enhance the frequency or expand the breadth of your current calling pattern? And historically, I seem to recall the pulmonology indication accounting for roughly 15% to 20% of the dollar value of the Acthar franchise. And I just wanted to see if that's sort of consistent with your read into that particular segment of the market as well.

好的。最後一個問題是關於 Cortrophin 的。 Nikhil，銷售人員的擴張是專門針對肺科醫生社區的，還是什麼也能使您提高頻率或擴大當前呼叫模式的廣度？從歷史上看，我似乎記得肺病學適應症約佔 Acthar 特許經營權美元價值的 15% 至 20%。我只是想看看這是否也與您對特定市場部分的解讀一致。

Yes. Thanks, Elliot. I think on your point on sales expansion, look, we're trying to find a balance between sharing information to assist the investment community while not giving away competitively sensitive data. So with that understanding, pulmonology is a critical part of the expansion. However, we may go beyond that, too, right? But I think in terms of sharing, I think pulmonology is the area that we'd like to share. And in terms of how much of Acthar sales it is, look, it's material enough for us to -- as a sector or sort of indication for us to say, "Hey, we'll have a dedicated sales force for it." And in terms of expanding and to reach those patients.

是的。謝謝，埃利奧特。我認為關於你關於銷售擴張的觀點，看，我們正試圖在共享信息以幫助投資界與不洩露競爭敏感數據之間找到平衡。因此，有了這種理解，肺病學就是擴張的關鍵部分。但是，我們也可以超越它，對嗎？但我認為就分享而言，我認為肺病學是我們想要分享的領域。就 Acthar 的銷售額而言，看，它對我們來說足夠重要——作為一個行業或某種跡象讓我們說，“嘿，我們將擁有一支專門的銷售隊伍。”並在擴大和接觸這些患者方面。

We'll take our next question from Vamil Divan with Guggenheim Securities.

我們將從古根海姆證券公司的 Vamil Divan 那裡回答下一個問題。

Great. So maybe just a couple more following up on the Cortrophin launch. And I appreciate your comments on not wanting to share too much competitive information. But a couple of questions just following up on what you did say. Can you maybe just comment a little bit on what you're seeing sort of in the field if physicians are sort of deciding between Cortrophin Gel and competing options, nice to see the growth return to that market, but in terms of differentiation, what is sort of driving the decision to use Cortrophin? And then just the second one, again, as much as you're willing to share kind of baked in your guidance or any comments on what you're assuming around gross to net would be helpful just for us if you want to comment.

偉大的。因此，也許在 Cortrophin 發布後還有幾個跟進。我很欣賞你不想分享太多競爭信息的評論。但是有幾個問題只是跟進你所說的話。如果醫生在 Cortrophin Gel 和競爭選擇之間做出決定，你能不能稍微評論一下你在該領域看到的東西，很高興看到該市場恢復增長，但就差異化而言，什麼是某種程度上推動了使用 Cortrophin 的決定？然後是第二個，再一次，只要你願意在你的指導中分享一些烘焙的東西，或者如果你想發表評論，你對你假設的關於淨值的任何評論都會對我們有所幫助。

Good morning, Vamil, and welcome to your first ANI earnings call. Two questions on the gross to net, we are again, back to the competitive point, we're not sharing that information at this time. And then in terms of dynamic with prescribers, look, we are continuing to see growth both in the number of unique prescribers or new unique prescribers as well as healthcare providers becoming repeat prescribers. They use it, they see the benefit and then they use it. And then the other thing to share is that we've seen the prescriber interest in having an alternate treatment in the ACTH category continue to build.

早上好，Vamil，歡迎來到您的第一個 ANI 財報電話會議。關於淨值的兩個問題，我們再次回到競爭點，我們現在不分享這些信息。然後就處方者的動態而言，看，我們繼續看到獨特處方者或新的獨特處方者數量以及醫療保健提供者成為重複處方者的增長。他們使用它，他們看到了好處，然後他們使用它。然後要分享的另一件事是，我們已經看到處方者對 ACTH 類別中的替代治療的興趣繼續增加。

And many of our prescribers had previously slowed or discontinued the use of the ACTH class prior to our launch. And then once we've launched and as we created awareness around Cortrophin Gel and the ACTH class, they've restarted their use of ACTH therapy. Of course, this is -- all of this is for the appropriate patients in need. And when you think of that, right, and this is why the point on the class and the growth in the class 8 months according to IQVIA year-on-year growth on a monthly basis -- sorry, monthly growth from a year-on-year basis. I think as you think of that, I think the important point to bear in mind is that if you look a few years ago, the number of patients that were benefiting from ACTH therapy was significantly higher than where we are today. And so that tells you that, again, as we're seeing this class growth that, that is -- that the prescriber interest in ACTH class and more appropriate patients continues to build.

在我們推出之前，我們的許多處方醫生之前已經放慢或停止使用 ACTH 類。然後，一旦我們推出並建立了對 Cortrophin Gel 和 ACTH 類的認識，他們就重新開始使用 ACTH 療法。當然，這是——所有這一切都是為了適合有需要的患者。當你想到這一點時，對的，這就是為什麼根據 IQVIA 月度同比增長，班級和班級增長 8 個月的原因 - 抱歉，月度同比增長-年的基礎。我認為當你想到這一點時，我認為要記住的重要一點是，如果你回顧幾年前，受益於 ACTH 治療的患者數量明顯高於今天。所以這再次告訴你，當我們看到這個類別的增長時，那就是 - 開處方者對 ACTH 類別和更合適的患者的興趣繼續建立。

And we'll take our next question from Greg Fraser with Truist Securities.

我們將從 Truist Securities 的 Greg Fraser 那裡回答下一個問題。

On Cortrophin, can you comment on the competitive environment? I'm not sure if I missed that. And just what you're seeing from the incumbent in terms of strategies to defend this business?

關於Cortrophin，您能評論一下競爭環境嗎？我不確定我是否錯過了。在捍衛這項業務的戰略方面，您從現任者那裡看到了什麼？

Yes. Let's cut to the chase, Greg. Look, we're again trying to find balance between sharing information that's helpful to the investment community, while not giving away competitively sensitive data. We know that our competitors are listening into this call. And I think, look, from the way we see it, and obviously, they did comment on this publicly, I think day before yesterday and then also a week ago that they're seeing stabilization in the demand and growth in the overall class and that they believe, I think -- and I think we're all about trying to increase the number of patients that can -- of appropriate patients that can benefit from this therapy, right, or -- and I think that's it. I think -- yes, that's what I feel comfortable sharing at this time.

是的。讓我們切入正題，格雷格。看，我們再次試圖在共享對投資界有幫助的信息與不洩露競爭敏感數據之間找到平衡。我們知道我們的競爭對手正在監聽這個電話。我認為，看，從我們的角度來看，很明顯，他們確實公開發表了評論，我認為前天和一周前，他們看到需求穩定，整體類別增長，他們相信，我認為 - 我認為我們都在努力增加可以從這種療法中受益的適當患者的數量，對吧，或者 - 我認為就是這樣。我想 - 是的，這就是我現在願意分享的內容。

Got it. This may fall under the same competitive sensitive category. But can you talk about the number of thoughts that you've been calling on and how that number -- have a number of prescribers of 510 compared with the overall (inaudible).

知道了。這可能屬於同一競爭敏感類別。但是你能談談你一直在呼籲的想法的數量以及這個數字是如何 - 與整體相比（聽不清）有 510 名開處方者。

Yes. Definitely competitively sensitive information. So we'll be steering clear of that. Thank you for understanding, Vamil.

是的。絕對是競爭敏感信息。所以我們會避開這一點。謝謝你的理解，瓦米爾。

Great. Understood. Okay. What about just the new patient starts, are those -- have those been ramping similarly with the case initiations, I guess -- that are payer approvals coming through?

偉大的。明白了。好的。只是新病人開始怎麼樣，我猜那些 - 那些是否與案件啟動類似 - 是付款人批准通過的？

Right. Yes. I think that the new patient starts are ramping. And I think one of the things that we will see in 2023 is that the new patient starts in Q4 will continue to -- as -- depending upon what kind of indications they are on -- the refill vials will keep the sort of coming from those. So our team obviously is focused on increasing the awareness and understanding of Cortrophin Gel. And there are, as you were pointing out, there's a number of factors that drive from the number of cases initiated to cases that meet the prior authorization criteria and are approved by the insurance plans and the time to dispense of the first vial and then there's also a variation in terms of the indication mix, right?

正確的。是的。我認為新患者開始增加。我認為我們將在 2023 年看到的一件事是，第四季度開始的新患者將繼續——因為——取決於他們所接受的適應症類型——補充瓶將保持來自那些。因此，我們的團隊顯然專注於提高對 Cortrophin Gel 的認識和理解。正如您所指出的，有許多因素會導致從啟動的案件數量到符合事先授權標準並獲得保險計劃批准的案件以及分配第一個藥瓶的時間，然後是在適應症組合方面也有所不同，對嗎？

So how many MS patients versus RA patients, versus lupus patients, versus nephrotic syndrome patients and the number of vials used for each indication varies and also then patients getting vials to our patients assistance program.

因此，有多少 MS 患者與 RA 患者、狼瘡患者、腎病綜合徵患者以及用於每種適應症的小瓶數量各不相同，然後患者將小瓶送入我們的患者援助計劃。

One other -- one more question. When do you expect the operational efficiencies from the consolidation of the manufacturing network to fully materialize?

另一個——還有一個問題。您預計製造網絡整合帶來的運營效率何時會完全實現？

Sorry, I missed that question. Sorry, go ahead.

對不起，我錯過了那個問題。對不起，繼續。

I can grab that one. Greg, thanks for the insightful questions. Yes, the full GAAP impact and most importantly, the cash flow impact from consolidating manufacturing and closing of the Oakville facility, we'll start to accrue into the results in 2023. Our operational plans to wind down the facility have tracked very much according to plan, and we are in the final days of -- manufacturing completed early this quarter, and we're in the process of moving and selling off certain fixed assets, et cetera. So we're in the final days of the wind down plan as we speak.

我可以抓住那個。格雷格，感謝您提出富有洞察力的問題。是的，完整的 GAAP 影響，最重要的是，合併製造和關閉奧克維爾工廠帶來的現金流影響，我們將在 2023 年開始計入業績。我們關閉該設施的運營計劃已根據計劃，我們正處於本季度初完成製造的最後幾天，我們正在移動和出售某些固定資產等。因此，就在我們說話的時候，我們正處於結束計劃的最後幾天。

So that cash flow impact will start to accrue in 2023 and certainly GAAP results on the P&L, we'll accrue in. As you know, Greg, on the non-GAAP results, in the non-GAAP EBITDA and non-GAAP EPS, we've been adding back certain portions of those savings, the impact of nonrecurring costs on the CDMO side in Canada, we've been adding those back since the second quarter of 2022. So a portion of that impact in effect is already reflected in the non-GAAP results.

因此，現金流影響將在 2023 年開始累積，當然 GAAP 結果對損益表的影響也會累積。正如你所知，格雷格，在非 GAAP EBITDA 和非 GAAP 每股收益中，我們一直在加回這些節省的某些部分，即非經常性成本對加拿大 CDMO 方面的影響，自 2022 年第二季度以來我們一直在加回這些費用。因此，部分影響已經反映在非 GAAP 結果。

Just before we move on, Greg, I think just coming back to your question on competitive dynamic -- just to be -- again, to try and be helpful to the investment community. I would point you to the fact that from -- according to IQVIA, 8 months consecutively, we've seen year-on-year growth in the class. So that's 1 data point. You also see the relative market share. That's another bit of it's in the public domain and then the short ones claims -- affecting the claims, and that gives you another data point. And finally, obviously, you see the published price. I think these are 3 or 4 data points that are available in the public domain that could be helpful to point to the competitive dynamic. And again, the overall as we see it, right, that the number of patients that were on ACTH therapy 3 to 4 years ago was much higher than where they are today. And we're increasing awareness and understanding of Cortrophin Gel to find the appropriate patients in need.

就在我們繼續之前，格雷格，我想回到你關於競爭動態的問題——只是為了——再次嘗試對投資界有所幫助。我要指出的事實是——根據 IQVIA 的數據，我們已經連續 8 個月看到班級人數同比增長。所以這是 1 個數據點。您還可以看到相對市場份額。這是它在公共領域的另一部分，然後是簡短的聲明——影響聲明，這給了你另一個數據點。最後，顯然，您會看到公佈的價格。我認為這些是公共領域中可用的 3 或 4 個數據點，可能有助於指出競爭動態。再一次，總體而言，正如我們所看到的那樣，3 到 4 年前接受 ACTH 治療的患者人數比今天要多得多。我們正在提高對 Cortrophin Gel 的認識和理解，以找到有需要的合適患者。

And we'll take our next question from Brandon Folkes with Cantor Fitzgerald.

我們將與 Cantor Fitzgerald 一起接受 Brandon Folkes 的下一個問題。

Congratulations on all the progress in 2022. I do just want to come back to the cash flow conversion and generation. So you reported adjusted EBITDA, I think, of $56 million operating cash burn, I think I heard you say, Steve, of $31 million, can you just elaborate on the moving pieces regarding cash flow generation in 2023? I didn't hear you're talking about getting better cash flow generation and strong cash flow generation at that. But just maybe help us bridge that $87 million gap between adjusted EBITDA in 2022 and operating cash flow. Is it really just interest payments and working capital build?

祝賀 2022 年取得的所有進展。我只想回到現金流的轉換和生成。所以你報告了調整後的 EBITDA，我認為是 5600 萬美元的運營現金消耗，我想我聽到你說，史蒂夫，3100 萬美元，你能詳細說明一下 2023 年現金流產生的變化嗎？我沒有聽到你在談論獲得更好的現金流生成和強大的現金流生成。但也許可以幫助我們彌合 2022 年調整後的 EBITDA 與運營現金流之間的 8700 萬美元差距。真的只是利息支付和營運資金積累嗎？

And then why should we not expect to continue to see a working capital build in '23 albeit perhaps lower in 2022? But just given the growth trajectory, I wondered your '23 guidance and then maybe what we are expecting for 2024. I know that's a lot in there, but maybe just to tack on top of that then how is your flexibility to bring in additional assets as you finance this organic growth and service the debt?

那麼為什麼我們不應該期望在 23 年繼續看到營運資金增加，儘管 2022 年可能會降低？但就增長軌跡而言，我想知道你的 23 年指導，然後可能是我們對 2024 年的預期。我知道那裡有很多，但也許只是為了解決這個問題，那麼你如何靈活地引入額外資產當你為這種有機增長提供資金並償還債務時？

Yes. Thanks, Brandon. Yes, I think, like, the biggest part of the bridge that you described is the change in working capital, right? And I think you have to understand that there's been extreme acceleration in sequential performance, both quarterly right? If you look at the quarters, obviously, out in the public domain, right, the company posted $94 million in sales versus $64.5 million in the first quarter of this year. And when you look at that year-over-year, as we said on the call, fourth quarter revenues are up $33 million year-over-year. And so at the December 31st balance sheet, right, a large portion of that sales gain year-over-year is sitting in AR, right?

是的。謝謝，布蘭登。是的，我認為，你所描述的橋樑的最大部分是營運資金的變化，對吧？而且我認為你必須明白，連續業績已經出現了極大的加速，都是季度性的，對嗎？如果你看一下季度，顯然，在公共領域，對，該公司公佈的銷售額為 9400 萬美元，而今年第一季度為 6450 萬美元。正如我們在電話會議上所說，當您查看同比時，第四季度收入同比增長 3300 萬美元。因此，在 12 月 31 日的資產負債表上，同比銷售增長的很大一部分來自 AR，對吧？

On top of that, we -- on the inventory side of working capital, right, we had a tremendous expansion of the business across both lines, right? So on the Generic side, obviously, we've launched over 20 products in 2022, right, so there's working capital builds on inventory to support those product launches and obviously, the effect on AR as we discussed. And then on the Purified Cortrophin Gel side, right, that's a product where supply chain is extremely important and the production of inventories there kind of happens more periodically, right, given the specialized nature of that product.

最重要的是，我們 - 在營運資金的庫存方面，對，我們在兩條線上都有巨大的業務擴張，對吧？因此，在通用方面，很明顯，我們在 2022 年推出了 20 多種產品，對，因此有建立在庫存基礎上的營運資金來支持這些產品的發布，顯然，正如我們所討論的那樣，對 AR 的影響。然後在 Purified Cortrophin Gel 方面，對，這是一種供應鏈極其重要的產品，考慮到該產品的特殊性，那裡的庫存生產更週期性地發生，對吧。

So you can have lumpiness in the inventory purchases on the Cortrophin side. So those impacts are very real and they're very significant when you look at that quarterly progression. And as you could imagine, right, if you were to unpack the fourth quarter, especially for those growth platforms, right, there tends to be a sequential growth within the month as well.

因此，您可以在 Cortrophin 方面購買庫存。因此，當您查看季度進展時，這些影響是非常真實的，而且非常重要。正如你所想像的那樣，如果你要打開第四季度的包裝，特別是對於那些增長平台，那麼一個月內往往也會出現連續增長。

So -- well, turning to -- and then on total company cash flows, right, obviously, the second biggest bill, if you will, in 2022 is on debt financing and servicing the debt finance bill. So that cost just shy of $24 million on interest and then $3 million of debt principal pay down. So those are the biggest impacts of cash flow in 2022. As we look forward to 2023, you're correct, we do expect to have continued sequential build, I think, right, but the impacts of the overall growth in the business in 2022 will start to manifest more in the cash flow and in the cash balance. And so we do expect that, right, as absolute growth percentages, moderated touch, right? We do expect that working capital component to be less severe than it was this year.

所以 - 好吧，轉向 - 然後是公司總現金流量，顯然，如果你願意的話，2022 年第二大賬單是關於債務融資和償還債務融資賬單。因此，利息成本略低於 2400 萬美元，然後是 300 萬美元的債務本金償還。所以這些是 2022 年現金流量的最大影響。當我們期待 2023 年時，你是對的，我們確實希望繼續連續構建，我認為，正確的，但是 2022 年業務整體增長的影響將開始更多地體現在現金流和現金餘額中。所以我們確實預計，作為絕對增長百分比，適度接觸，對吧？我們確實預計營運資金部分不會像今年那樣嚴重。

Just one other thing to add, Brandon, is that we also have the sale of the Oakville facility as a good positive cash flow item to think about.

布蘭登，要補充的另一件事是，我們也將出售奧克維爾工廠作為一個很好的正現金流項目來考慮。

And we'll take our next question from Oren Livnat with H.C. Wainwright.

我們將與 H.C. 一起接受 Oren Livnat 的下一個問題。溫賴特。

I have a couple. On Cortrophin, I understand you have to keep things close to the vest competitively here. But just in general, on approval of coverage trends, are those time lines shrinking materially? And you discussed you're continuing to work to improve coverage and access. So how would you characterize your, I guess, without specifics, but just your relative positioning to Acthar at launch and now and should we expect any material changes in Q1, whether normal seasonal headwinds from resetting of plans in prior offs, et cetera, or actual potential tailwinds with new coverage wins kicking in? And I have a follow-up.

我有一對。關於 Cortrophin，我知道你必須在這裡競爭地保持接近背心的東西。但總的來說，在批准覆蓋趨勢後，這些時間線是否會大幅縮短？你討論過你將繼續努力提高覆蓋率和訪問率。那麼，我想，你會如何描述你的，我想，沒有具體細節，但只是你在發佈時和現在與 Acthar 的相對定位，我們應該期待第一季度的任何重大變化，無論是正常的季節性逆風來自先前關閉的計劃重置，等等，還是新報導獲勝的實際潛在順風開始了嗎？我有一個後續行動。

Yes. Thank you for your questions. Yes. Look, again, the specifics on market access and rather coverage positions is fairly competitively sensitive information. I think that, as I mentioned during my prepared remarks, that we're continuing to work to increase and improve the market access for patients in need, both with coverage decisions as well as what's helping to our reimbursement team just helping to reduce the time from enrollment to fulfillment. I should probably steer clear of giving any further specifics beyond that because the last time I checked (inaudible) were actually listening into my call. So.

是的。謝謝你的問題。是的。再一次，關於市場准入和覆蓋範圍的細節是相當具有競爭性的敏感信息。我認為，正如我在準備好的發言中提到的那樣，我們正在繼續努力增加和改善有需要的患者的市場准入，包括覆蓋範圍決定以及對我們的報銷團隊有幫助的只是幫助減少時間從報名到完成。我可能應該避免提供任何進一步的細節，因為我上次檢查（聽不清）實際上是在聽我的電話。所以。

But in terms of seasonality in Q1, I mean, we normally -- especially in rare expensive drugs, we expect a headwind in Q1. Should we just make the standard assumption that, that's the case for your product like most or in theory, as you're entering your first full year, are you hoping to have a new win?

但就第一季度的季節性而言，我的意思是，我們通常 - 特別是在稀有昂貴藥物方面，我們預計第一季度會出現逆風。我們是否應該做出標准假設，即您的產品大多數情況就是這種情況，或者理論上，當您進入第一個完整的年度時，您是否希望獲得新的勝利？

So I think you're exactly right that there is a dynamic that's typical for rare disease launches between Q4 and Q1, such as patients searching insurance plans and the impact of that. And I think that ANI's rare disease products will sort of follow suit on that.

所以我認為你是完全正確的，在第四季度和第一季度之間存在罕見疾病發布的典型動態，例如患者搜索保險計劃及其影響。而且我認為 ANI 的罕見疾病產品會在某種程度上效仿這一點。

Perfect. And you did mention bolstering the pulmonology support. And I think it's pretty vague, but maybe other areas, I'm assuming you're referring to whatever differentiation you have indication-wise versus Acthar, which I guess is not competitive information. It's in the label. So maybe you could talk about it. How material do you view the opportunity in any differentiated indications you have versus Acthar?

完美的。你確實提到了加強肺科支持。我認為這很模糊，但也許在其他領域，我假設你指的是你在指示方面與 Acthar 的任何區別，我想這不是競爭信息。它在標籤上。所以也許你可以談談。與 Acthar 相比，您如何看待您在任何差異化適應症中的機會？

Yes. We're not -- you're right. So we -- it is in the label, and we do have differentiated indications versus Acthar, but we're not sharing anything at this time. And I think the second part on pulmonology -- sorry, the other indications, I think, yes, we point of view in the direction of the modest sales force expansion in the area of pulmonology and I think that, that's appropriate to share.

是的。我們不是——你是對的。所以我們——它在標籤中，我們確實有與 Acthar 不同的適應症，但我們目前沒有分享任何東西。我認為關於肺病學的第二部分——抱歉，其他跡象，我認為，是的，我們的觀點是在肺病學領域適度擴大銷售隊伍的方向，我認為，這很適合分享。

Okay. And then just a couple of financial ones. There are more operating leverage in 2023. What are the biggest drivers there in terms of the ranges, bull and bear case scenarios margin-wise? Is it just how much you choose to invest on the OpEx side? Or is there some material variability in the gross margins of the underlying business units? Actually, I think I missed in your remarks, did you give company gross margin guidance there? And on Generics, specifically, just directionally, given you're launching -- expect to launch competitive generic therapies, is it possible gross margins overall in the Generics business can increase in 2023? Or is that -- would that be too aggressive an assumption? And should we assume that they're flat at best?

好的。然後只是幾個財務方面的。 2023 年會有更多的經營槓桿。就範圍、牛市和熊市情況而言，最大的驅動因素是什麼？您選擇在 OpEx 方面投資多少？或者基礎業務部門的毛利率是否存在重大差異？實際上，我想我在你的話中漏掉了，你在那裡給了公司毛利率指導嗎？在仿製藥方面，具體來說，只是定向地，鑑於你正在推出 - 期望推出有競爭力的仿製藥，仿製藥業務的整體毛利率是否有可能在 2023 年增加？或者是——這樣的假設會不會過於激進？我們是否應該假設它們充其量是平坦的？

Yes, Oren. So yes, we did comment on total company gross margin profile and we tagged that at 59.5% to 61%, and that would be on a non-GAAP basis. And as you think about the different puts and takes in the ranges in the guidance, certainly, one of them is just how the sales mix does play out. As we've talked about in the past, right, Purified Cortrophin Gel is a favorable input as it grows to our overall company gross margin profile. And -- however, there is a touch of headwind year-over-year as I had cited in Elliot's question at the top of the Q&A, in our kind of other revenue categories, right, the other -- and the one that I didn't say on Elliot's call, which is to remain is in the area of royalties. So would you expect royalty income to decline year-over-year.

是的，奧倫。所以是的，我們確實對公司的總毛利率情況發表了評論，我們將其標記為 59.5% 至 61%，這將基於非公認會計原則。當你考慮指南中不同的看跌期權和接受範圍時，當然，其中之一就是銷售組合如何發揮作用。正如我們過去所討論的那樣，對，純化的 Cortrophin 凝膠是一種有利的投入，因為它對我們公司的整體毛利率狀況有所增長。而且 - 然而，正如我在問答頂部的艾略特問題中所引用的那樣，在我們的其他收入類別中，對，另一個 - 以及我沒有的那個更不用說在埃利奧特的呼籲下，這仍然是在版稅領域。那麼您是否預計特許權使用費收入會同比下降。

And obviously, royalty income has 100% gross margin profile. And then as you know, right, our established brands business, which has a high brand margin profile rate tends to be a declining asset year-over-year without business development impact on it. And so there's puts and takes, right, in that gross margin profile guidance. And then the other aspects, right, are just the implied ranges. Again, we haven't given SG&A and R&D guidance, right, but the implied ranges of that kind of total OpEx. And those are in relatively tight ranges, but the decision there. And as we've said, right, we're very focused on continuing to invest behind the 2 growth platforms and this is our point of view at a moment in time, right? Obviously, as the year develops, and we get more experience under our belt with the performance and the continued trajectory, obviously, we'll update as appropriate.

顯然，特許權使用費收入的毛利率為 100%。然後，正如您所知，我們的知名品牌業務具有較高的品牌利潤率，但在沒有業務發展影響的情況下，其資產往往會逐年下降。因此，在該毛利率概況指南中有看跌期權。然後其他方面，對，只是隱含的範圍。同樣，我們沒有給出 SG&A 和 R&D 指導，對吧，但給出了這種總運營支出的隱含範圍。那些都在相對狹窄的範圍內，但決定在那裡。正如我們所說，對，我們非常專注於繼續投資這兩個增長平台，這是我們目前的觀點，對吧？顯然，隨著時間的推移，我們在性能和持續軌跡方面獲得了更多經驗，顯然，我們會適當更新。

And can you comment on the directionality of generic gross margins or no?

您能否評論通用毛利率的方向性？

Yes. Right. Yes, your question. So I would say gross margins for the Generic business can absolutely expand. And the first thing that I would point to you there, right, is just the overall aggregate age of the portfolio, right, as you know, right, gross margin profiles and generics which tend to be best at the launch date. And then as competitive pressures kick in as time goes on, you would have margin compression and so as we are in an era of multiple generic launches off of the strength of the R&D platform, that lowers the aggregate age of our portfolio and is a positive contributor to the generic gross margin profile.

是的。正確的。是的，你的問題。所以我想說仿製藥業務的毛利率絕對可以擴大。我要向你指出的第一件事就是投資組合的總年齡，正如你所知，正確的是，毛利率概況和仿製藥在發布之日往往是最好的。然後隨著時間的推移競爭壓力開始出現，你會壓縮利潤率，所以我們正處於一個依靠研發平台的力量推出多個仿製藥的時代，這降低了我們投資組合的總年齡，這是一個積極的對通用毛利率概況的貢獻。

So just to clarify, or build on what Steve said, he says that it can expand, but it for the -- we haven't given specific guidance on the mix, right, was giving you what the -- for the mix of the 3 years, right? And he was telling you about the moving parts.

所以只是為了澄清，或者以史蒂夫所說的為基礎，他說它可以擴展，但它 - 我們沒有給出關於混合的具體指導，對，是給你什麼 - 對於混合3年，對吧？他告訴你有關活動部件的信息。

Yes. No promises in Generics. Building on -- everyone's question is on cash. Like I'm not an accountant, so I'm sorry, this is a dumb question. But just when we talk about besides the investments in inventory and other working capital investments, when we just talk about accounts receivable and how that's grown over the year, just to clarify, is that really just a function of time and growth of revenue, net payment terms and obviously a rapidly growing top line? Or is there potentially any difference in the regular collection cycle with the new orphan business versus the legacy generics? Is there something unique about accounts receivable collections on the orphan side?

是的。泛型中沒有承諾。建立在 - 每個人的問題都是關於現金的。就像我不是會計師，所以很抱歉，這是一個愚蠢的問題。但是，當我們談論除了庫存投資和其他營運資本投資之外，當我們只談論應收賬款以及它在過去一年中的增長情況時，只是為了澄清一下，這真的只是時間和收入增長的函數，淨額付款條件和明顯快速增長的收入？或者，新的孤兒企業與遺留仿製藥的常規收集週期是否存在潛在差異？孤兒方的應收賬款催收有什麼獨特之處嗎？

Yes, sure. So I'll answer -- the first part is in 2022, the utilization of cash and what's sitting in AR is largely driven by just the normal cycle and the significantly accelerating sequential growth, again, even within the months, right, in terms of looking forward and as Purified Cortrophin Gel becomes a bigger overall mix of our business, the -- I'll say, generally speaking, right, the contractual relationships and contractual terms for that type of branded product, right, are more favorable than the terms that we would expect in the Generic business. So that should be another underlying positive factor as Purified Cortrophin Gel grows as an overall percentage of our business.

是的，當然。所以我會回答——第一部分是在 2022 年，現金的使用和 AR 中的資產主要是由正常週期和顯著加速的連續增長驅動的，再次，即使在幾個月內，正確的，就展望未來，隨著 Purified Cortrophin Gel 成為我們業務的一個更大的整體組合，我會說，一般來說，這種品牌產品的合同關係和合同條款，對，比條款更有利我們在通用業務中所期望的。因此，這應該是另一個潛在的積極因素，因為 Purified Cortrophin Gel 在我們業務中所佔的比例不斷增長。

And we'll take a follow-up question from Elliot Wilbur with Raymond James.

我們將與 Raymond James 一起回答 Elliot Wilbur 的後續問題。

Just going back to Cortrophin. As we think about modeling the trajectory of the product and the various treatment curves and persistent trends within your 3 primary indications, any particular area where you're seeing overperformance perhaps versus the historical ACTH usage pattern? I guess some of the early data suggest that relative usage in nephrotic syndrome is much higher than what we've seen with Acthar. So I don't know if that's just a function of not enough data points or if, in fact, that's something that you're seeing as well.

只是回到Cortrophin。當我們考慮對產品的軌跡和您的 3 個主要適應症中的各種治療曲線和持續趨勢進行建模時，您看到的任何特定領域可能與歷史 ACTH 使用模式相比表現超常？我想一些早期數據表明腎病綜合徵的相對使用率比我們在 Acthar 中看到的要高得多。所以我不知道這是否只是數據點不足的結果，或者事實上，這是否也是您所看到的。

And then a bigger-picture question. As we start to see the ACTH market recover in terms of unit volumes, anything you could say in terms of sort of the patient dynamics there? I understand most of these patients would be sort of new to therapy, meaning they haven't been on either control for Acthar probably for 12 months. But any perspective you can offer at least at this early stage in terms of patients who may actually be treatment-naive or not previously on ACTH therapies in terms of the mix? And last question, I'm sure I know the response already, but Acthar labeling is differentiated because it has the infantile spasm indication, anything you can say about your plans in that area as well?

然後是一個更大的問題。當我們開始看到 ACTH 市場在單位數量方面復甦時，您能就那裡的患者動態說些什麼？我知道這些患者中的大多數都是治療的新手，這意味著他們可能已經 12 個月沒有接受過 Acthar 的任何控制。但是，至少在這個早期階段，您可以提供任何關於實際上可能未接受過治療或之前未接受過 ACTH 治療的患者的觀點嗎？最後一個問題，我肯定我已經知道答案了，但是 Acthar 標籤是有區別的，因為它有嬰兒痙攣症的跡象，你能說說你在那個領域的計劃嗎？

So thanks, Elliot. Insightful questions as always. Look, your question on are we seeing sort of favorable dynamics on 1 patient or 1 indication versus another versus what Acthar has historically had, we'll probably need to steer clear of that, because that points in a direction of focus that could be valuable for -- so it's competitively sensitive. So that's one. I think on patient dynamics, I think what we can share is there are prescribers who were writing or using the ACTH class, and they had either stopped or reduced their writing considerably and their interest as we have driven sort of greater understanding around Cortrophin Gel, awareness and understanding of Cortrophin Gel, we've seen their interest continue to build, and that's -- and you can -- sort of what I can share is there are prescribers that are writing their first prescription of Cortrophin Gel and there are prescribers that are writing multiple prescriptions of Cortrophin Gel.

所以謝謝，埃利奧特。一如既往的有見地的問題。聽著，你的問題是我們是否在一名患者或一項適應症上看到了某種有利的動態，而不是 Acthar 歷史上的情況，我們可能需要避開這一點，因為這指向了一個可能有價值的關注方向因為 - 所以它具有競爭敏感性。這就是一個。我認為在患者動態方面，我認為我們可以分享的是，有些處方醫生正在編寫或使用 ACTH 課程，他們已經停止或大大減少了他們的寫作和他們的興趣，因為我們已經推動了對 Cortrophin Gel 的更深入的理解，對 Cortrophin Gel 的認識和理解，我們已經看到他們的興趣在不斷增加，這就是——你可以——我可以分享的是，有些處方醫生正在寫他們的第一個 Cortrophin Gel 處方，並且有些處方醫生正在寫 Cortrophin 凝膠的多個處方。

And I guess what you can see from that is the patients that they put on Cortrophin Gel potentially you're seeing, right, so I think that they see the impact of that and they make the decision to decide which are the appropriate patients to continue to put on Cortrophin Gel. I think that's what I can share.

我想你可以從中看到他們使用 Cortrophin Gel 的患者，你可能會看到，對，所以我認為他們看到了這種影響，他們決定決定哪些患者適合繼續治療塗上 Cortrophin 凝膠。我想這就是我可以分享的。

And then the last one, again, look, these are all dynamics that we are -- just to be clear, these are all dynamics that we believe are favorable and therefore, you see that our guidance for 2023 is 92% to 116% higher. And that's why you see -- sorry, 92% is 116% higher than 2022. And that's why you see that the ACTH class has grown month-on-month, consecutively 8 months in a row. And then your third question on the IS indication, competitively sensitive information. So I just want to say before we move on, I just want to thank all of you for your patience and understanding as we -- again, we're all -- we're trying to find that balance between giving the investment community as much information with sharing in competitively sensitive information in a 2-player market, right? So.

然後是最後一個，再一次，看，這些都是我們的動力——需要明確的是，這些都是我們認為有利的動力，因此，你會看到我們對 2023 年的指導高出 92% 到 116% .這就是為什麼你看到——抱歉，92% 比 2022 年高出 116%。這就是為什麼你看到 ACTH 類別連續 8 個月環比增長。然後是關於 IS 指示的第三個問題，競爭敏感信息。所以我只想說，在我們繼續之前，我只想感謝你們所有人的耐心和理解，因為我們 - 再一次，我們都是 - 我們正在努力在給投資界作為在 2 人市場中共享競爭敏感信息的大量信息，對嗎？所以。

There are no further questions at this time. I'll turn the call back over to Nikhil Lalwani for our closing remarks.

目前沒有其他問題。我會將電話轉回給 Nikhil Lalwani 以作結束語。

Thank you, Ashley, and thank you, everyone, for joining our call this morning. ANI is well positioned to deliver sustainable growth, and we look forward to updating you on the continued progress. We appreciate your time and interest in ANI, and thank you.

謝謝 Ashley，也謝謝大家今天早上加入我們的電話會議。 ANI 已準備好實現可持續增長，我們期待著向您通報最新進展。感謝您抽出寶貴的時間和對 ANI 的興趣，謝謝。

Thank you.

謝謝。

Thank you. And this does conclude today's program. Thank you for your participation. You may disconnect at any time.

謝謝。今天的節目到此結束。感謝您的參與。您可以隨時斷開連接。