Biofrontera Inc (BFRI) 2026 Q1 法說會逐字稿

Good day, and welcome to Biofrontera Inc first quarter 2026 financial results and business update conference call. (Operator Instructions) Please note this event is being recorded. I would like to turn the conference over to Ben Shamsian, Investor Relations. Please go ahead.

各位好，歡迎參加 Biofrontera Inc 2026 年第一季財務業績與業務更新電話會議。(接線員指示) 請注意，本活動將被錄音。現在我想把會議交給投資人關係的 Ben Shamsian。請開始。

Good morning, and welcome to Biofrontera Inc's first quarter 2026 financial results and business update conference call. Please note that certain information discussed during today's call by management is covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act.

各位早安，歡迎參加 Biofrontera Inc 2026 年第一季財務業績與業務更新電話會議。請注意，管理層在今日電話會議中討論的某些資訊，受《私人證券訴訟改革法案》(Private Securities Litigation Reform Act) 的「安全港」條款所涵蓋。

We caution listeners that Biofrontera's management will be making forward-looking statements and that actual results may differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. All risks and uncertainties are detailed in and are qualified by the cautionary statements contained in Biofrontera's press releases and SEC filings, including the company's quarterly report on Form 10-Q for the quarter ended March 31, 2026, and the company's annual report on Form 10-K for the year ended December 31, 2025.

我們提醒聽眾，Biofrontera 管理層將發表前瞻性陳述；由於與公司業務相關的風險與不確定性，實際結果可能與這些前瞻性陳述所述或所暗示者存在重大差異。所有風險與不確定性均已在 Biofrontera 的新聞稿與向 SEC 提交的文件中詳述，並受其中警示性陳述所限制與規範，包括截至 2026 年 3 月 31 日季度的 Form 10-Q 季度報告，以及截至 2025 年 12 月 31 日年度的 Form 10-K 年度報告。

Also, this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast. Biofrontera undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as required by law.

此外，本電話會議包含具時效性的資訊，僅在本次直播日期當日為準確。除法律要求外，Biofrontera 不承擔在本次電話會議日期之後，為反映事件或情況而修訂或更新任何前瞻性陳述的義務。

During today's call, there will be references to certain non-GAAP financial measures. Biofrontera believes these measures provide useful information for investors yet should not be considered as a substitute for GAAP nor should they be viewed as a substitute for operating results determined in accordance with GAAP. A reconciliation of non-GAAP to GAAP results is included in the press release issued today and is available on the company's website at www.biofrontera-us.com under the Investor Relations section. Please note, management will be referencing adjusted EBITDA, a non-GAAP financial measure, defined as net income or loss excluding interest income and expense, income taxes, depreciation and amortization and certain other nonrecurring or noncash items, including changes in fair value of warrant liabilities and stock-based compensation.

在今日電話會議中，將提及若干非 GAAP 財務衡量指標。Biofrontera 認為這些指標可為投資人提供有用資訊，但不應被視為 GAAP 的替代，也不應被視為依 GAAP 所確定之營運結果的替代。非 GAAP 與 GAAP 結果之調節表已包含於今日發布的新聞稿中，並可於公司網站 www.biofrontera-us.com 的「投資人關係」專區取得。請注意，管理層將引用調整後 EBITDA（Adjusted EBITDA）這一非 GAAP 財務衡量指標，其定義為淨利或淨損，排除利息收入與費用、所得稅、折舊與攤銷，以及某些其他非經常性或非現金項目，包括認股權證負債公允價值變動與股份基礎給付。

With that said, I would like to now turn the call over to Hermann Luebbert, CEO, Chairman and Founder of Biofrontera.

接下來，我想把電話會議交給 Biofrontera 的執行長、董事長兼創辦人 Hermann Luebbert。

Thank you, Ben, and thank you to everyone joining us this morning. The first quarter of 2026 was strong across our key metrics. We delivered product revenues of USD10.1 million, an increase of approximately 17% compared to USD8.6 million in the first quarter of 2025. This marks the first full quarter reflecting our new cost structure following the strategic transaction with Biofrontera AG and the results demonstrate that our business model transformation is delivered as planned. These results further demonstrate the strength of our commercial execution and the growing adoption of Ameluz PDT across the dermatology community. George Jones, our CCO, will follow up about this in more detail.

謝謝你，Ben，也感謝今天早上加入我們的各位。2026 年第一季在我們的關鍵指標上表現強勁。我們實現產品營收 1,010 萬美元，較 2025 年第一季的 860 萬美元增加約 17%。這是與 Biofrontera AG 完成策略性交易後、反映我們新成本結構的第一個完整季度；結果顯示，我們的商業模式轉型如計畫交付。這些成果也進一步展現我們商業執行的實力，以及皮膚科社群對 Ameluz PDT 採用度的提升。我們的首席商務長（CCO）George Jones 將在稍後更詳細說明。

As a reminder, the strategic transaction, which closed in October 2025, gave Biofrontera Inc full ownership and control of all US rights, approvals and patents for Ameluz and RhodoLED, including the New Drug Application, the Investigational New Drug application, all manufacturing rights and contracts and all intellectual property. The FDA formally transferred the NDA and IND to us in December 2025.

提醒各位，該策略性交易於 2025 年 10 月完成交割，使 Biofrontera Inc 完全擁有並掌控 Ameluz 與 RhodoLED 在美國的所有權利、核准與專利，包括新藥申請（NDA）、臨床試驗用新藥申請（IND）、所有製造權利與合約，以及所有智慧財產權。FDA 已於 2025 年 12 月正式將 NDA 與 IND 轉移至我們名下。

Under the new earnout structure, we pay 12% of net sales when annual US Ameluz revenues are at or below USD65 million and 15% when they exceed that threshold. This replaced the transfer pricing model that previously was 25% to 35% of revenue. The impact of this is clearly visible in our Q1 results. Our gross margin expanded to approximately 80% compared to approximately 62% in the prior year quarter. And our cash used in operations was near 0 at just USD70,000, a dramatic improvement from USD4.1 million used in operations in Q1 2025, and sets the path for cash flow breakeven this year. Fred Leffler, our CFO, will provide more detail on the financial performance in a few moments.

在新的分期對價（earnout）結構下，當美國 Ameluz 年度營收淨額在 6,500 萬美元以下（含）時，我們支付淨銷售額的 12%；超過該門檻時則支付 15%。此舉取代了先前的移轉訂價模式，當時為營收的 25% 至 35%。其影響在我們第一季業績中清楚可見。我們的毛利率擴大至約 80%，相較於去年同期約 62%。而我們營運活動使用的現金幾乎為 0，僅 7 萬美元；相較 2025 年第一季營運活動使用現金 410 萬美元大幅改善，並為今年達成現金流損益兩平奠定路徑。我們的財務長（CFO）Fred Leffler 將在稍後提供更多財務表現細節。

Let me now turn to the significant clinical and regulatory progress we have made during and since the first quarter. First, in superficial basal cell carcinoma. In February 2026, we announced that the FDA completed its filing review and accepted our supplemental New Drug Application for Ameluz PDT for the treatment of superficial basal cell carcinoma.

接下來談談我們在第一季期間及其後取得的重要臨床與法規進展。首先是淺表型基底細胞癌（superficial basal cell carcinoma）。2026 年 2 月，我們宣布 FDA 已完成送件審查並受理我們就 Ameluz PDT 用於治療淺表型基底細胞癌所提交的補充新藥申請（sNDA）。

The PDUFA target action date is September 28, 2026. If approved, Ameluz would be the first PDT drug approved to treat a cancer in the United States, representing a significant additional commercial opportunity for our platform and providing a significant advantage to what our direct competitor can do.

PDUFA 目標行動日期為 2026 年 9 月 28 日。若獲核准，Ameluz 將成為美國首個獲准用於治療癌症的 PDT 藥物，為我們的平台帶來顯著的額外商業機會，並使我們相較直接競爭對手具備明顯優勢。

Second, in actinic keratosis on the extremities, neck and trunk. In February 2026, we announced positive and statistically significant top line results from our Phase III clinical trial. The study met its primary endpoint, demonstrating highly statistically significant superiority for Ameluz versus vehicle gel.

第二是四肢、頸部與軀幹的日光性角化症（actinic keratosis, AK）。2026 年 2 月，我們宣布第三期臨床試驗取得正面且具統計顯著性的主要結果。該研究達成主要終點，顯示 Ameluz 相較於賦形劑凝膠（vehicle gel）具有高度統計顯著的優越性。

Additionally, we announced the database lock of the Phase I pharmacokinetic study required for our FDA filing. Combined, these data support our plan to file a supplemental NDA in the third quarter of 2026 to expand the Ameluz label for the treatment of AK beyond the face and scalp on the treatment field of up to 240 square centimeters. With approximately 58 million American adults having at least one AK lesion, treating extensive fields on the extremities, neck and trunk represents a very large addressable market for our installed base of RhodoLED lamps.

此外，我們宣布已完成 FDA 申報所需之第一期藥物動力學（pharmacokinetic）研究的資料庫鎖定（database lock）。綜合上述資料，支持我們計畫於 2026 年第三季提交補充 NDA，以擴大 Ameluz 標籤適應症：將 AK 的治療範圍從臉部與頭皮延伸至其他部位，且治療面積可達 240 平方公分。約有 5,800 萬名美國成年人至少有一處 AK 病灶；在四肢、頸部與軀幹進行大範圍治療，對我們已安裝的 RhodoLED 燈具基礎而言，代表非常龐大的可服務市場。

Third, in moderate to severe acne vulgaris. In March 2026, we announced the results of our Phase II study with Ameluz PDT. The 3-hour incubation protocol demonstrated a 58% reduction in inflammatory lesions with Ameluz compared to 37% with vehicle gel in the protocol population. Patient satisfaction was very high with 86% of patients stating they would choose PDT treatment again.

第三是中度至重度尋常性痤瘡（moderate to severe acne vulgaris）。2026 年 3 月，我們公布 Ameluz PDT 第二期研究結果。在方案族群中，3 小時孵育（incubation）方案顯示：使用 Ameluz 的發炎性病灶減少 58%，相較之下賦形劑凝膠為 37%。病患滿意度非常高，86% 的病患表示他們會再次選擇 PDT 治療。

Based on this data, we plan to discuss the design of future Phase III program with the FDA in the second half of 2026. Acne vulgaris is a chronic condition affecting millions of adults and adolescents, and we believe Ameluz PDT has the potential to offer a differentiated treatment option for the moderate to severe form of the disease.

基於這些數據，我們計劃於2026年下半年與FDA討論未來第三期（Phase III）計畫的設計。尋常性痤瘡是一種影響數以百萬計成人與青少年的慢性疾病，我們相信 Ameluz PDT 具有潛力，為中重度病程提供具差異化的治療選項。

On the corporate front, I am pleased to report that on May 6, 2026, we received written notification from Nasdaq confirming that the company has regained compliance with the Minimum Bid Price Requirement under Listing Rule 5550(a)(2). The closing bid price of our common stock was at or above USD1 per share for the required 10 consecutive business days.

在公司層面，我很高興報告，於2026年5月6日，我們收到納斯達克（Nasdaq）的書面通知，確認公司已重新符合《上市規則》5550(a)(2)項下的最低買入價要求。我們普通股的收盤買入價在規定的連續10個營業日內均達到或高於每股1美元。

Finally, I want to note that we continue to monitor the evolving global trade environment, including recently imposed tariffs on imports from certain countries. As our products are exclusively imported from Europe, we are routinely assessing the potential impact on our supply chain, product cost and pricing strategy.

最後，我想指出，我們持續監測不斷演變的全球貿易環境，包括近期對自特定國家進口商品所加徵的關稅。由於我們的產品皆自歐洲獨家進口，我們正例行性評估其對供應鏈、產品成本及定價策略的潛在影響。

I would now like to turn the call over to George Jones, our Chief Commercial Officer, to provide a more detailed update on our commercial execution.

接下來我想把電話會議交給我們的首席商務長 George Jones，請他就我們的商業執行提供更詳細的更新。

Thank you, Hermann, and good morning, everybody. I'm pleased to walk you through our commercial progress for the first quarter of 2026.

謝謝你，Hermann，各位早安。我很高興向各位說明我們在2026年第一季的商業進展。

As Hermann noted, we delivered product revenues of USD10.1 million, an increase of approximately 17% year-over-year. The revenue increase was primarily driven by approximately 16% growth in Ameluz unit volume as well as a price increase that we implemented in the fourth quarter of 2025.

如 Hermann 所提到，我們的產品營收為1,010萬美元，年增約17%。營收成長主要由 Ameluz 銷售單位數約16%的成長所帶動，並且也受益於我們在2025年第四季實施的調價。

Looking at the Ameluz unit volume growth, Ameluz unit volumes for the first quarter of 2026 increased from approximately 25,000 tubes in Q1 2025 to approximately 29,000 tubes of Ameluz in Q1 2026, translating to an approximately 16% year-over-year growth. This follows our record sales in Q4. This continued volume momentum reflects the impact of the execution improvements we have implemented and the growing adoption of Ameluz PDT.

就 Ameluz 銷售單位數成長來看，2026年第一季 Ameluz 的銷售量由2025年第一季約25,000支（tubes）增加至2026年第一季約29,000支，換算為年增約16%。這延續了我們在第四季創下的銷售紀錄。這股持續的量能動能反映了我們已落實的執行改善所帶來的影響，以及 Ameluz PDT 的採用度持續提升。

Turning to lamps, the RhodoLED lamp placements. During Q1 of 2026, we shipped approximately 32 lamps, increasing our installed base to approximately 773 lamps across 709 dermatology offices as of March 31, 2026.

接著談到燈具，也就是 RhodoLED 燈的布建。在2026年第一季，我們出貨約32台燈具，使得截至2026年3月31日，我們在709家皮膚科診所的裝機基數提升至約773台。

When we look at our sales force execution, our focused commercial strategy is delivering the momentum we're seeing. The strategy is centered on increased accountability across our commercial organization, refined customer segmentation and data-driven targeting assisted by AI. We continue to focus on increased in-person sales activity because we know this drives the highest impact with our customers. We also saw the benefits of lower sales force turnover in Q1 2026 versus Q1 2025 as our newer reps have been able to get to know their customers and their territories, they're better able to drive results.

從我們的銷售團隊執行來看，我們聚焦的商業策略正在帶動目前所見的動能。該策略以提升整體商業組織的問責性、精細化客戶分群，以及在AI輔助下以數據驅動的目標鎖定為核心。我們仍持續聚焦提升面對面銷售活動，因為我們知道這能對客戶產生最大的影響。相較於2025年第一季，我們在2026年第一季也看到較低的銷售團隊流動率所帶來的效益；較新的業務代表已能更熟悉其客戶與所負責的區域，因此更能推動成果。

I also wanted to follow up on something we discussed during our last call. In Q4 2025, we launched an inside sales pilot to cover vacant territories, white space and smaller accounts. I'm excited to share that in Q1, we've begun the full rollout of this program, and it's already started to deliver results for us.

我也想就我們在上次電話會議中討論的一點做個後續說明。在2025年第四季，我們啟動了一項內勤銷售（inside sales）試點計畫，用以覆蓋空缺區域、白地市場（white space）以及較小型的客戶。我很高興分享，在第一季我們已開始全面推行此計畫，而且它已開始為我們帶來成果。

The growing installed lamp base, lower sales force turnover, expanded customer adoption, along with the potential for expanded uses for Ameluz with the near-term label expansion in sBCC and AK in the trunk and extremities as well as the advancement of the acne program give us multiple vectors for continued growth and tailwinds for our business. I look forward to updating you on our progress in coming quarters.

持續擴大的燈具裝機基數、較低的銷售團隊流動率、客戶採用度提升，再加上 Ameluz 在短期內於 sBCC 以及軀幹與四肢 AK 的標籤擴增所帶來的擴大用途潛力，以及痤瘡計畫的推進，為我們帶來多重持續成長的向量與業務順風。我期待在未來幾季向各位更新我們的進展。

With that, I'll turn the call over to Fred Leffler, our Chief Financial Officer, to walk through the financial results.

接下來，我把電話會議交給我們的首席財務長 Fred Leffler，請他帶各位回顧財務結果。

Thank you, George, and good morning, everyone. I'll walk through our financial results for the first quarter ended March 31, 2026. All comparisons are to the prior year period unless otherwise noted. A full reconciliation of our GAAP to non-GAAP measures is included in the press release we issued earlier today and also available on our website.

謝謝你，George，各位早安。我將說明截至2026年3月31日止第一季的財務結果。除非另有說明，所有比較皆以去年同期為基準。我們在今日稍早發布的新聞稿中已提供 GAAP 與非 GAAP 指標的完整調節表，亦可於我們的網站查閱。

So starting with first quarter 2026 results. Revenues for the first quarter were approximately USD10.1 million compared with approximately USD8.6 million in the first quarter of 2025, an increase of 17%. The increase was primarily driven by the 16% growth in Ameluz unit volume, and the impact of the price increase we implemented in the fourth quarter of 2025 which contributed about USD0.2 million in additional revenue. This was the first full quarter reflecting our new cost structure under the strategic transaction mentioned earlier and our cost of revenues decreased by approximately 40% year-over-year from USD3.1 million to USD1.8 million.

先從2026年第一季的結果開始。第一季營收約為1,010萬美元，較2025年第一季約860萬美元增加17%。成長主要由 Ameluz 銷售單位數16%的成長所帶動，此外我們在2025年第四季實施的調價影響亦貢獻約20萬美元的額外營收。這是先前提及之策略性交易後、新成本結構下反映的第一個完整季度；我們的營收成本年減約40%，由310萬美元降至180萬美元。

Under the new earnout agreement, our cost of revenue as a percentage of product revenue declined significantly compared to the 25% transfer price that was in effect during Q1 of 2025. During the quarter, we recognized USD1.2 million of earnout expense under this new agreement. As a result, our gross profit on product sales improved significantly with a gross margin of approximately 80% compared with 62% in the first quarter of 2025, an improvement of 18%. This is consistent with our expected annualized benefit of the new cost structure that will be reflected throughout 2026 and is tracking towards our longer-term gross margin target of 80% to 85%.

在新的或有對價（earnout）協議下，我們的營收成本占產品營收的比例，較2025年第一季適用的25%移轉價格（transfer price）顯著下降。本季我們依該新協議認列120萬美元的或有對價費用。因此，我們產品銷售的毛利顯著改善，毛利率約為80%，相較於2025年第一季的62%提升18個百分點。這與我們對新成本結構之年度化效益的預期一致，該效益將在2026年全年持續反映，並正朝向我們較長期的80%至85%毛利率目標推進。

Total operating expenses for the first quarter of 2026 were USD14.4 million compared with USD13.1 million in the first quarter of 2025. Excluding cost of revenues, operating expenses were USD12.3 million compared to USD9.9 million in the prior year. Operating expenses for the quarter include a USD0.4 million patent remediation expense, which I will discuss further when I get to operating loss.

2026年第一季總營業費用為1,440萬美元，較2025年第一季的1,310萬美元增加。若排除營收成本，營業費用為1,230萬美元，較去年同期的990萬美元增加。本季營業費用包含40萬美元的專利補救（patent remediation）費用，我在談到營業損失時會進一步說明。

Selling, general and administrative expenses were USD11.0 million for the first quarter of 2026 compared with USD8.7 million in the prior year quarter, an increase of USD2.3 million or about 27%. I'll walk through and highlight the key components.

2026年第一季銷售、一般及行政費用為1,100萬美元，較去年同期的870萬美元增加230萬美元，約增27%。我將逐項說明並重點強調主要構成。

Selling and marketing expenses increased about USD0.8 million, reflecting the full deployment of our direct sales team and higher sales activity levels, including sales meetings, conferences and exhibits. General and administrative expenses increased about USD0.8 million as well, primarily driven by legal expenses associated with ongoing patent related claims.

銷售與行銷費用增加約80萬美元，反映我們直銷團隊的全面部署以及較高的銷售活動水準，包括銷售會議、研討會與展覽。一般及行政費用亦增加約80萬美元，主要由與持續進行之專利相關主張所產生的法律費用所帶動。

Additionally, in connection with the strategic transaction, we assumed responsibility for the manufacturing operations in the fourth quarter of 2025. Because we are in the process of securing approvals and licenses to commence manufacturing later in 2026, these manufacturing-related costs of USD0.6 million were reflected in SG&A during this quarter.

此外，與該策略性交易相關，我們於2025年第四季承擔製造營運的責任。由於我們正處於取得核准與許可、以於2026年稍晚開始製造的過程中，本季與製造相關的60萬美元成本已反映於SG&A之中。

Research and development expenses decreased USD0.3 million to USD0.9 million for the first quarter of 2026, down from USD1.2 million in the prior year quarter. The decrease was primarily attributable to certain clinical trials reaching substantial completion during the quarter. And during the quarter, we invested in our AK acne superficial basal cell carcinoma and lamps development programs.

2026年第一季研發費用減少30萬美元至90萬美元，較前一年同期的120萬美元下降。下降主要歸因於若干臨床試驗於本季達到實質完成。此外，本季我們也投資於AK、痤瘡、淺表性基底細胞癌以及燈具的開發計畫。

Operating loss for the first quarter of 2026 was USD4.3 million compared with a loss of USD4.5 million in the first quarter of 2025. The quarter included the USD0.4 million of patent remediation expense, which we exclude because they relate to discrete adverse legal and regulatory matters that are not indicative of the company's ongoing operating performance. Excluding this expense, our underlying operating loss for the first quarter of 2026 would have been approximately USD3.9 million and an improvement of USD0.7 million, driven by USD2.7 million increase in gross profit and partially offset by USD2.3 million increase in SG&A.

2026年第一季營業損失為430萬美元，較2025年第一季的450萬美元損失為低。本季包含40萬美元的專利補救費用；我們將其排除，因其與個別不利的法律與監管事項相關，並不代表公司持續營運表現。若排除此費用，2026年第一季的基礎營業損失約為390萬美元，改善70萬美元，主要由毛利增加270萬美元所帶動，並部分被SG&A增加230萬美元所抵銷。

Net loss for the first quarter of 2026 was USD4.8 million or USD0.41 per share compared with a net loss of USD4.2 million or USD0.47 per share in the prior year quarter. The net loss comparison was impacted by two nonrecurring items: the patent remediation I just discussed, and a USD0.8 million swing in the noncash change in fair value -- in the fair value of warrant liabilities, a USD0.5 million gain in Q1 of 2025 compared to USD0.2 million loss in Q1 of 2026. Adjusting for these items, the underlying improvement is reflected in our adjusted EBITDA, which I'll turn to now.

2026年第一季淨損為480萬美元，或每股0.41美元；相較之下，前一年同期淨損為420萬美元，或每股0.47美元。淨損比較受到兩項非經常性項目影響：我剛提到的專利補救，以及認股權證負債公允價值之非現金變動出現80萬美元的擺動——2025年第一季為50萬美元收益，而2026年第一季為20萬美元損失。就這些項目調整後，基礎改善反映在我們的調整後EBITDA上，我接下來將說明。

Turning to adjusted EBITDA, our non-GAAP measure, the first quarter was negative USD3.6 million compared with a negative USD4.4 million in the prior year quarter, an improvement of approximately USD0.8 million. Our adjusted EBITDA margin improved to negative 35% from negative 51% in the prior year. The improvement was primarily driven by the USD2.7 million increase in gross profit offset by the USD2.3 million increase in SG&A.

談到調整後EBITDA（我們的非GAAP衡量指標），第一季為負360萬美元，較前一年同期的負440萬美元改善約80萬美元。我們的調整後EBITDA利潤率由前一年的負51%改善至負35%。改善主要由毛利增加270萬美元所帶動，並被SG&A增加230萬美元所抵銷。

As a reminder, adjusted EBITDA excludes interest taxes, depreciation and amortization, certain other nonrecurring or noncash items, including changes in fair value of warrant liabilities, stock-based comp and the patent remediation expense and inventory write-down recognized during the quarter. A full reconciliation from GAAP net loss to adjusted EBITDA is included in the press release we filed earlier today and will be filed as part of our Form 10-Q.

提醒一下，調整後EBITDA排除利息、稅項、折舊與攤銷，以及其他若干非經常性或非現金項目，包括認股權證負債公允價值變動、股份基礎給付，以及本季認列的專利補救費用與存貨減記。從GAAP淨損到調整後EBITDA的完整調節表已包含於我們今日稍早提交的新聞稿中，並將作為我們Form 10-Q的一部分提交。

Now turning to balance sheet and liquidity. As of March 31, 2026, we had cash and cash equivalents of USD6.3 million compared with USD6.4 million as of December 31, 2025. Cash used in operating activities for the first quarter was just USD70,000 compared with USD4.1 million in the prior year quarter. This near breakeven cash performance represents a dramatic improvement and reflects the combined impact of higher revenues, the significantly lower cost structure under the new earnout agreement and favorable working capital changes, including a USD3.4 million collection of accounts receivable.

接著談資產負債表與流動性。截至2026年3月31日，我們的現金及約當現金為630萬美元，較2025年12月31日的640萬美元略降。第一季營運活動使用的現金僅7萬美元，較前一年同期的410萬美元大幅下降。這接近損益兩平的現金表現代表顯著改善，反映較高營收、新的或有對價（earnout）協議下顯著較低的成本結構，以及有利的營運資金變動之綜合影響，其中包括收回340萬美元的應收帳款。

As we have disclosed in our filings, the company has included a going concern qualification in its statements. While we have demonstrated meaningful progress towards cash flow breakeven, our current capital resources require us to continue expanding our commercial operations while controlling expenses. We plan to address this through continued Ameluz revenue growth, realization of the next milestone payment of USD1 million from the Xepi divestiture that happened in 2025, and if necessary, securing a working capital line of credit or the like.

如同我們在申報文件中揭露，公司在其財務報表中納入繼續經營（going concern）之保留意見。雖然我們已展現朝向現金流量損益兩平的實質進展，但以目前資本資源而言，我們仍需在控制費用的同時持續擴大商業營運。我們計畫透過Ameluz營收持續成長、實現2025年Xepi剝離所帶來的下一筆100萬美元里程碑款項，並在必要時取得營運資金信用額度或類似融資來因應。

So with that overview of our financial results and business activities, we are now ready to take questions from our covering analysts.

以上為我們財務結果與業務活動的概述，接下來我們準備回答追蹤我們的分析師提問。

(Operator Instructions) Jonathan Aschoff, ROTH Capital Partners.

(接線員指示) Jonathan Aschoff，ROTH Capital Partners。

As to what you might know about off-label use...

關於你可能了解的適應症外使用（off-label use）……

Jonathan, I'm sorry, you were not audible. Can you start again, please?

Jonathan，抱歉，你的聲音聽不清楚。可以請你再開始一次嗎？

Okay. Can you hear me now?

好的。你現在聽得到我嗎？

Yes.

聽得到。

Congrats on a nice quarter. Can you guys help me understand the extent to which there's off-label use into probably the least risky is AK in the extremities? Do you have any decent sense as to Ameluz' use outside of what's on label?

恭喜本季表現不錯。你們能否幫我理解一下適應症外使用的程度？可能風險最低的是四肢的AK。你們對Ameluz在標示適應症之外的使用情況，有沒有任何合理的掌握？

There's certainly some off-label use. However, since some payers are quite sensitive to that and refuse to reimburse the doctors when they do this, doctors are usually hesitant doing off-label use. So the -- while we don't have access to any clear numbers, we don't expect that the current off-label use outside AK on the face and scalp, at least in the AK business, is small.

確實存在一些適應症外使用。不過，由於部分付款方對此相當敏感，當醫師這麼做時會拒絕給付，因此醫師通常會對適應症外使用有所顧慮。因此——雖然我們無法取得任何明確數字，但我們預期目前在臉部與頭皮AK之外的適應症外使用（至少在AK業務方面）規模不大。

Okay. Can you give us a sense of what kind of directions the acne, the subsequent clinical development in acne could go? I mean, are you definitely expecting to already be teed up for a Phase III trial? Or do you think you could actually have to do some Phase II development again?

了解。你能否說明一下痤瘡後續臨床開發可能的方向？我的意思是，你們是否確定已經準備好進入第三期試驗？或者你們認為可能還需要再做一些第二期開發？

That's difficult to say because it needs to be discussed with the FDA. I don't think we need Phase II again. I think we got the information we need to go into Phase III. There have been quite a number of learnings, and the clinical results are well in line with the best other topical products that are out there. So we think if the -- unless the FDA has a different idea, we could go straight into Phase III.

這很難說，因為需要與FDA討論。我不認為我們需要再做第二期。我認為我們已取得進入第三期所需的資訊。我們有相當多的學習收穫，而臨床結果也與市面上其他最佳外用產品的表現相當一致。因此我們認為，除非FDA有不同看法，我們可以直接進入第三期。

And Jonathan, I just want to add that while we've heard of some off-label use, we market and ensure that everyone at Biofrontera markets the product on label and doesn't encourage anything that's outside of the label.

Jonathan，我只是想補充一下，雖然我們聽說有一些超適應症使用，但我們在行銷上會確保 Biofrontera 的每一位同仁都依照核准標示（on-label）推廣產品，且不會鼓勵任何超出標示範圍的使用。

Bruce Jackson, StoneX.

StoneX 的 Bruce Jackson。

Good morning. So looking at the supplemental NDA for the superficial BCC, I believe you've got a PDUFA date of September 28. So if you do get the approval, are you ready to launch like the next day? Or is there any other additional preparation activity that needs to take place before you can go out and start marketing aggressively?

早安。關於淺表型基底細胞癌（superficial BCC）的補充 NDA，我相信你們的 PDUFA 日期是 9 月 28 日。如果你們獲得核准，是否隔天就能準備好上市？或者在你們能夠開始積極行銷之前，還需要進行其他額外的準備工作？

I could take that, Hermann. This is George. We -- there is...

Hermann，我可以回答這題。我是 George。我們——目前……

Sorry to interrupt you, but your voice is breaking. Can you check, please? Thank you.

抱歉打斷你，但你的聲音斷斷續續。可以請你檢查一下嗎？謝謝。

Can you hear me?

你聽得到我嗎？

Yes.

聽得到。

Yes.

聽得到。

Okay. Perfect. There is no additional work or preparation that has to be done. We're actively preparing for the launch of that indication right now, and we're going to start some initial rollout with our medical team and some rollout from our commercial team in Q4, really accelerating into the launch into Q1 of next year, but we're ready to go and starting right after the approval.

好。很好。不需要做任何額外工作或準備。我們目前正積極為該適應症的上市做準備，並將在第四季由醫學團隊先行展開初步推廣，同時商業團隊也會進行部分推進；真正的加速會在明年第一季的上市階段，但我們已經準備就緒，核准後就會立即開始。

Okay. Got it. And then a question about the SG&A expenses. So Fred, you did a nice job of kind of breaking that out. Is this kind of the run rate we should be looking at for the remainder of the year? Or were there any other types of sort of onetime things embedded in there that might roll off?

好的。了解。接著想問一下 SG&A（銷售、一般及行政）費用。Fred，你把它拆解得很清楚。這是否就是我們在今年剩餘期間應該預期的費用水準（run rate）？或者其中是否包含任何一次性項目，之後可能會消失？

Well, as we've discussed before, there is a bit of seasonality to our business. So like the cash used in operations will most likely dip negative in Q3 and into Q4, unless we blow it out of water, and then be positive in Q4. And altogether, we're still expecting to hit cash flow breakeven. That said, the run rate that I did mention, we don't expect anything to drastically move off of that.

如同我們之前討論過的，我們的業務確實有一些季節性。因此，營運活動使用的現金在第三季以及進入第四季時，很可能會轉為負值，除非我們表現遠超預期，然後在第四季轉為正值。整體而言，我們仍預期能達到現金流損益兩平。話雖如此，我剛才提到的費用水準，我們不預期會有任何大幅度的下降。

Okay, okay. And then last question on gross margins. It's nice to see the agreements having some impact on the year-over-year improvement. How does this unfold for the remainder of the year as you try to get closer to your new target?

好的，好的。最後一題關於毛利率。很高興看到這些協議對年對年改善有一些影響。在今年剩餘期間，當你們試圖更接近新的目標時，這會如何發展？

Well, I think that we're in the range and we will continue to look at the GPOs, we will continue to look at our discounting and manage that and -- because our goal, and I think it's very, very achievable, is to stay within the 80% to 85%. And that can shift around because of those and the mix of Ameluz and lamp sales as they develop throughout the year. So it's something we'll look at. It's very manageable, and we expect to easily stay in those -- within that range.

我認為我們目前已在該區間內，並且會持續檢視 GPO（團體採購組織），也會持續檢視並管理我們的折扣策略——因為我們的目標，而且我認為非常、非常可達成，就是維持在 80% 到 85% 之間。而這個數字可能會因上述因素，以及 Ameluz 與燈具銷售在全年發展過程中的組合（mix）而有所波動。所以這是我們會持續關注的事項。這非常可控，我們預期能輕鬆維持在——也就是在該區間內。

All right. So it appears we have no further questions at this time. I would like to return the program to management for the closing remarks. Over to you, team.

好的。看起來目前沒有其他問題。我想把會議交回管理團隊做結語。交給你們了，團隊。

Thank you, operator, and thank you to everyone who joined us today. Let me leave you with a few key takeaways. The first is that our first quarter 2026 demonstrates the full impact of our transformed business model. Revenue grew 17% year-over-year, gross margin expanded to approximately 80%, and our cash consumption was near 0, validating the strategic transaction and giving us confidence in our path to sustained profitability.

謝謝接線員，也謝謝今天加入我們的各位。我想用幾個重點作結。第一，我們 2026 年第一季的表現展現了我們轉型後商業模式的完整影響。營收年增 17%，毛利率擴大至約 80%，現金消耗接近 0，驗證了這項策略性交易，並讓我們對邁向可持續獲利的路徑更有信心。

Second, our clinical pipeline continues to deliver results at an accelerated pace. We have a PDUFA date for sBCC in September 2026, positive Phase III results for AK on neck, trunk and extremities that position us for an sNDA filing in Q3 and encouraging Phase II data in acne that we will discuss with the FDA later this year.

第二，我們的臨床研發管線持續以加速的步伐交付成果。我們的 sBCC 在 2026 年 9 月有一個 PDUFA 日期；AK（光化性角化症）在頸部、軀幹與四肢的第三期試驗結果為正面，使我們有條件在第三季提交 sNDA；而痤瘡的第二期數據也令人鼓舞，我們將在今年稍晚與 FDA 討論。

Looking further ahead, we have planned studies in squamous cell carcinoma in situ and reduced pain PDT. Biofrontera is the only company in the United States actively running FDA controlled clinical studies in PDT for dermatology, and our patent protection extends through 2043. And finally, the combination of revenue growth, the full benefit of our new cost structure and disciplined expense management is driving meaningful improvement in our financial trajectory.

展望更長期，我們已規劃針對原位鱗狀細胞癌以及降低疼痛的 PDT 研究。Biofrontera 是美國唯一一家在皮膚科 PDT 領域積極進行 FDA 管控臨床研究的公司，而我們的專利保護延伸至 2043 年。最後，營收成長、新成本結構的完整效益，以及嚴謹的費用管理相結合，正推動我們的財務軌跡出現顯著改善。

We remain focused on our goal of reaching cash flow breakeven and building long-term value for our shareholders. I want to thank our entire team for their dedication and hard work. I also want to thank our shareholders, the healthcare professionals who use our products and most importantly, the patients whose lives we are helping to improve in the fight against skin disease. Thank you for your continued support. Have a wonderful day.

我們仍專注於達成現金流損益兩平的目標，並為股東創造長期價值。我要感謝我們整個團隊的投入與辛勞。我也要感謝我們的股東、使用我們產品的醫療專業人員，以及最重要的——我們正在協助改善其生活、共同對抗皮膚疾病的病患。感謝各位持續的支持。祝各位有美好的一天。

Thank you, sir. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

謝謝您。本次電話會議到此結束。感謝您參加今天的簡報。您現在可以掛線。