Biofrontera Inc (BFRI) 2024 Q2 法說會逐字稿

Good day, and welcome to the Biofrontera Inc. second quarter 2024 financial results and business update conference call. (Operator Instructions) Please note, this event is being recorded.

美好的一天，歡迎參加 Biofrontera Inc. 2024 年第二季財務表現和業務更新電話會議。（操作員說明）請注意，正在記錄此事件。

I would now like to turn the conference over to Andrew Barwicki. Please go ahead.

我現在想將會議轉交給安德魯·巴威基（Andrew Barwicki）。請繼續。

Thank you. Good morning, and welcome to Biofrontera's second quarter fiscal year 2024 financial results and business update conference call.

謝謝。早安，歡迎參加 Biofrontera 2024 財年第二季財務業績及業務更新電話會議。

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. 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.

請注意，管理層在今天的電話會議中討論的某些資訊受《私人證券訴訟改革法案》的安全港條款管轄。我們提醒聽眾，Biofrontera 的管理階層將做出前瞻性聲明，由於與公司業務相關的風險和不確定性，實際結果可能與這些前瞻性聲明中明示或暗示的結果有重大差異。

All risks and uncertainties are detailed in and are qualified by the cautionary statements contained in Biofrontera's press releases and SEC filings. Also, this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, August 15, 2024. 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.

所有風險和不確定性均在 Biofrontera 新聞稿和 SEC 文件中包含的警告聲明中詳細說明並受到限制。此外，本次電話會議包含時間敏感訊息，僅截至本次直播之日（2024 年 8 月 15 日）準確。除法律要求外，Biofrontera 不承擔修改或更新任何前瞻性陳述以反映本次電話會議日期之後發生的事件或情況的義務。

During today's call, there will be references to certain non-GAAP financial measures. Biofrontera believes that 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 this week's press release.

在今天的電話會議中，將會提到某些非公認會計準則財務指標。Biofrontera 認為，這些措施為投資者提供了有用的信息，但不應被視為 GAAP 的替代品，也不應被視為根據 GAAP 確定的經營業績的替代品。本週的新聞稿中包含非公認會計原則與公認會計原則結果的調節。

More specifically, 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 non-recurring or non-cash items.

更具體地說，管理層將參考調整後的EBITDA，這是一種非公認會計準則財務指標，定義為淨收入或虧損，不包括利息收入和費用、所得稅、折舊和攤銷以及某些其他非經常性或非現金項目。

With that said, I'm pleased now to turn the call over to Hermann Luebbert, CEO, Chairman and Founder of Biofrontera. Hermann?

話雖如此，我現在很高興將電話轉給 Biofrontera 執行長、董事長兼創辦人 Hermann Luebbert。赫爾曼？

Yes. Thank you, Ambu, and my thanks to everyone joining us this morning. On today's call, I'll provide an overview of our accomplishments during the second quarter and first half of 2024. Fred Leffler, our CFO, will follow with a discussion on financial results, and then both of us will be happy to answer questions after our prepared remarks.

是的。謝謝你，安布，也感謝今天早上加入我們的所有人。在今天的電話會議上，我將概述我們在 2024 年第二季和上半年的成就。我們的財務長 Fred Leffler 隨後將討論財務業績，然後我們倆將很樂意在準備好的發言後回答問題。

Starting with the business update. We have made tremendous progress across three critical areas, including, one, first and foremost, our sales report. Increasing sales during the second quarter and first half of the year has been accomplished, we grew our sales by 34% for the quarter.

從業務更新開始。我們在三個關鍵領域取得了巨大進展，其中之一是我們的銷售報告。第二季和上半年的銷售額成長已經完成，本季銷售額成長了34%。

In Q2, we managed to compensate the negative influence of the reimbursement challenges stemming from the change health care cybersecurity event and the consecutive sales decline in Q1 achieving a little over 8% growth compared to 2023 for the half year.

第二季度，我們成功彌補了醫療保健網路安全事件變化帶來的報銷挑戰以及第一季銷售額連續下降的負面影響，與 2023 年相比，半年實現了略高於 8% 的增長。

Two, managing our total operating expenses. For example, during the second quarter of 2024, total operating expenses were $12.9 million compared to $14.5 million in the second quarter of last year. Another example relates to our SG&A expenses, where in Q2 this year, the SG&A was $7.9 million compared to $11.6 million last year.

第二，管理我們的總營運費用。例如，2024 年第二季的總營運費用為 1,290 萬美元，而去年第二季為 1,450 萬美元。另一個例子與我們的 SG&A 支出有關，今年第二季度，SG&A 為 790 萬美元，而去年為 1,160 萬美元。

Three, strengthening our balance sheet by paying down all outstanding debt in the second quarter.

第三，透過在第二季償還所有未償債務來加強我們的資產負債表。

I believe these three simple yet significant accomplishments on the commercial side of the company, have enhanced our day-to-day operations and put us in a position for long-term growth. Together with the rise of gross $8 million in May from exercised warrants, the company is in a stable financial condition.

我相信公司商業方面的這三項簡單但意義重大的成就增強了我們的日常運營，並使我們處於長期成長的地位。加上 5 月行權認股權證總額增加 800 萬美元，該公司財務狀況穩定。

The second quarter was also a very anticipated time for us as we began to sell the FDA-approved RhodoLED XL. Keep in mind, sales only began on June 10, which is the end of the quarter, but we feel very optimistic about the potential as we continue rolling it out and making it available to all our customers. It is important to understand the benefits for doctors and patients as we look to increase sales.

第二季對我們來說也是一個非常令人期待的時刻，因為我們開始銷售 FDA 批准的 RhodoLED XL。請記住，銷售從 6 月 10 日（即季度末）才開始，但隨著我們繼續推出並向所有客戶提供，我們對其潛力感到非常樂觀。當我們希望增加銷售額時，了解對醫生和患者的好處非常重要。

The BF-RhodoLED XL lamp is designed to facilitate the treatment of extended photo damaged thin areas with actinic keratosis which may require several illuminations with the original small BF-RhodoLED lamp. While Ameluz makes upmost of our revenue, we are also proud to announce that in addition to the initial RhodoLED XL lamp sales, 57 of the original BF-RhodoLED lamps were placed at physician offices during the first half of the year compared to 52 in the same period last year.

BF-RhodoLED XL 燈旨在促進治療具有光化性角化病的大面積光損傷薄區域，這些區域可能需要使用原始小型 BF-RhodoLED 燈多次照明。雖然 Ameluz 佔據了我們的大部分收入，但我們也很自豪地宣布，除了最初的 RhodoLED XL 燈銷售之外，今年上半年，醫生辦公室放置了 57 盞原始 BF-RhodoLED 燈，而去年同期為 52 盞。去年同期。

The growing number of lamps in the field reflects both first-time installations and additional lamps among dermatology practices already familiar with Ameluz PDT, facilitating growth through new and existing customers.

該領域的燈數量不斷增加，反映出皮膚科實踐中已經熟悉 Ameluz PDT 的首次安裝和額外燈，從而促進了新客戶和現有客戶的成長。

Although we are very pleased with some reductions in costs such as SG&A and total operating expenses, we continue to invest in our commercial and support teams by increasing sales force focused organization to invest in marketing, strategic accounts, medical and reimbursement support.

儘管我們對 SG&A 和總營運費用等成本的下降感到非常高興，但我們繼續投資於我們的商業和支援團隊，增加以銷售人員為中心的組織，投資於行銷、策略客戶、醫療和報銷支援。

We believe this approach will increase Ameluz purchases by the doctor's offices, which then need unproblematic patient treatment and reimbursement to make this process financially viable for them.

我們相信這種方法將增加醫生辦公室對 Ameluz 的購買量，然後醫生辦公室需要沒有問題的患者治療和報銷，以使這一過程在經濟上對他們來說是可行的。

Although the RhodoLED XL lamp began selling at the end of the quarter, which we sell the minimal, it is important to understand the benefits for patients as we look to increase sales. The RhodoLED XL is for the treatment of extended photo damaged thin areas with actinic keratosis.

儘管 RhodoLED XL 燈在本季末開始銷售（我們銷售量最少），但在我們尋求增加銷售量時了解其為患者帶來的好處非常重要。RhodoLED XL 用於治療患有光化性角化病的大面積光損傷薄區域。

To eliminate restrictions on reimbursement for the use of more than one tube of Ameluz in a single treatment, a three tube Phase 1 safety study was completed, and the data was submitted to the FDA and accepted for review.

為了消除在單次治療中使用多管 Ameluz 的報銷限制，完成了三管 1 期安全研究，並將數據提交給 FDA 並接受審查。

We expect that FDA approval for including the use of up to three tubes per treatment into the Ameluz label during Q4 of 2024. In combination with the launch of the XL lamp, this will allow PDT of larger skin areas, constituting a crucial requirement for our further growth.

我們預計 FDA 將在 2024 年第四季批准將每次治療最多使用三管的 Ameluz 標籤納入其中。結合 XL 燈的推出，這將允許對更大的皮膚區域進行 PDT，這是我們進一步發展的關鍵要求。

As previously announced, the US Food and Drug Administration, the FDA, has approved a new formulation of Ameluz lacking propylene glycol for the treatment of actinic keratosis. First stretches with this formulation have now reached the market. The formulation will improve tolerability for some of our patients while also reducing the generation of impurities over time, which may result in an extended shelf life.

如同先前所宣布的，美國食品藥物管理局 (FDA) 已批准一種不含丙二醇的 Ameluz 新配方用於治療光化性角化症。採用該配方的第一批產品現已上市。配方將提高一些患者的耐受性，同時減少隨著時間的推移雜質的產生，這可能會延長保質期。

Between all our patents currently granted by the US patent office, PDT with Ameluz and BF-RhodoLED is currently protected until 2040. A patent application for the new formulation is still pending and may extend the protection of our products until 2043 or even further.

在美國專利局目前授予的所有專利中，Ameluz 和 BF-RhodoLED 的 PDT 目前的保護期限到 2040 年。新配方的專利申請仍在審理中，可能會將我們產品的保護期延長至 2043 年甚至更久。

A transforming event for our company was the successful renegotiation of our license and supply agreement for Ameluz and RhodoLED lamps in February. According to the agreement, we purchase Ameluz and the lamps from the German Biofrontera Pharma and upon arrival in the United States, we pay a percentage of our anticipated net sales price for Ameluz and the actual cost of manufacturing plus 10% for the lamps.

2 月份，我們成功重新談判了 Ameluz 和 RhodoLED 燈的許可和供應協議，這對我們公司來說是一個轉型事件。根據協議，我們從德國 Biofrontera Pharma 購買 Ameluz 和燈，抵達美國後，我們支付 Ameluz 預期淨銷售價格的一定百分比和實際製造成本加上燈的 10%。

The cost of Ameluz has in the new LSA being reduced to almost half of what we have paid thus far. This will become effective when we order new batches, which we did not have to do in the first half of this year, due to an over stacking situation by the end of 2023.

新 LSA 中 Ameluz 的成本幾乎降低到了我們迄今為止所支付費用的一半。這將在我們訂購新批次時生效，由於到 2023 年底會出現過度堆放的情況，今年上半年我們不必這樣做。

However, we will need to purchase more Ameluz in the second half of the year. Only then will the beneficial effects of the new LSA become effective lowering our cost of Ameluz from about 50% to 25% of our net sales price for all orders in 2024 and 2025.

然而，下半年我們需要購買更多的 Ameluz。只有到那時，新 LSA 的有益效果才會生效，將我們 2024 年和 2025 年所有訂單的 Ameluz 成本從約 50% 降低至 25%。

On June 1, we transferred all clinical research with Ameluz from Biofrontera Bioscience to our wholly owned German subsidiary, Biofrontera Discovery. While all our clinical products are performed at centers in the US. The price will nevertheless be organized and managed out of the Biofrontera Discovery. We are planning to complete all ongoing trials and in parallel decide on new trials based on maximum commercial benefit for Biofrontera Inc.

6 月 1 日，我們將 Ameluz 的所有臨床研究從 Biofrontera Bioscience 轉移到我們的全資德國子公司 Biofrontera Discovery。雖然我們所有的臨床產品都是在美國的中心進行的。儘管如此，價格仍將在 Biofrontera Discovery 之外進行組織和管理。我們計劃完成所有正在進行的試驗，同時根據 Biofrontera Inc. 的最大商業利益決定新的試驗。

Three ongoing trials are close to completion. The last patient in the one-year follow-up period for a Phase III trial for superficial basal cell carcinoma will be complete in November or December. This time point provides the data required for FDA approval for this new indication for Ameluz.

三項正在進行的試驗即將完成。表淺基底細胞癌 III 期試驗一年追蹤期的最後一名患者將於 11 月或 12 月完成。該時間點提供了 FDA 批准 Ameluz 這項新適應症所需的數據。

Enrollment in the Phase III study for actinic keratosis on the extremities neck and trunk and a Phase II trial for moderate to severe acne is expected around the turn of the year. Currently, the extremity study is 69% enrolled. The acne is at 78%.

預計將在今年年初招募四肢、頸部和軀幹光化性角化病的 III 期研究以及中度至重度痤瘡的 II 期試驗。目前，肢體研究的入組率為 69%。痤瘡率為78%。

As the cost savings due to the renegotiated LSA has not started, but we consume the cost of the clinical trials since June, we will, for a few months, have an increased run rate until the reduced cost of goods balances dissolved towards the end of the year.

由於重新協商的 LSA 帶來的成本節約尚未開始，但我們自 6 月以來就消耗了臨床試驗的成本，因此我們將在幾個月內提高運行率，直到 2019 年底商品餘額成本減少為止。年。

With that, I'll turn the call over to Fred to walk through the financial details of the second quarter and first half.

接下來，我將把電話轉給 Fred，詳細介紹第二季和上半年的財務細節。

Thank you, Hermann, and it's great to be talking to everyone again. I'll start with our strong second quarter 2024 results.

謝謝你，赫爾曼，很高興再次與大家交談。我將從 2024 年第二季的強勁業績開始。

Total revenues for the second quarter of 2024 were $7.8 compared with $5.8 million for the second quarter of 2023, which is a 34% increase year-over-year. The increase is due in part to a catch-up from lower sales in the first quarter driven by reimbursement challenges stemming from the change health care, cybersecurity events, but also due to our effort to increase productivity of the sales force.

2024 年第二季的總營收為 7.8 美元，而 2023 年第二季的總營收為 580 萬美元，較去年同期成長 34%。這一增長的部分原因是第一季銷售額下降，原因是醫療保健變革、網路安全事件帶來的報銷挑戰，但也歸因於我們努力提高銷售人員的生產力。

Total operating expenses were $12.9 million for the second quarter of 2024 compared with $14.5 million for the second quarter of 2023. Cost of revenues was $4.3 million for the second quarter of 2024 compared with $2.9 million for the prior year quarter. The increase was driven by increased sales and the volume associated with that.

2024 年第二季的總營運費用為 1,290 萬美元，而 2023 年第二季的總營運費用為 1,450 萬美元。2024 年第二季的營收成本為 430 萬美元，而去年同期為 290 萬美元。這一增長是由銷售額和與之相關的銷量增加所推動的。

Selling, general and administrative expenses were $7.9 million for the second quarter of 2024 compared with $11.5 million for the second quarter of 2023. The decrease was due to our continued efforts to control costs and lower legal expenses compared to the same period in 2023.

2024 年第二季的銷售、一般和管理費用為 790 萬美元，而 2023 年第二季為 1,150 萬美元。減少的原因是我們繼續努力控製成本並與 2023 年同期相比降低法律費用。

The net loss for the second quarter of 2024 was $257,000 and compared with a net loss of $9.8 million for the prior year quarter. The decrease in the net loss is attributed to lower selling, general and administrative costs as well as changes in non-cash P&L items, including the fair value of warrants and investments in related parties.

2024 年第二季的淨虧損為 25.7 萬美元，而去年同期的淨虧損為 980 萬美元。淨虧損的減少歸因於銷售、一般和管理成本的降低以及非現金損益項目的變化，包括認股權證和關聯方投資的公允價值。

Adjusted EBITDA for the second quarter of 2024 was negative $4.7 million compared with negative $7.9 million for the second quarter of 2023, reflecting our lower selling, general and administrative costs.

2024 年第二季調整後 EBITDA 為負 470 萬美元，而 2023 年第二季為負 790 萬美元，反映出我們的銷售、一般和管理成本較低。

As Andrew mentioned, we look at adjusted EBITDA as a non-GAAP financial measure as a better indication of ongoing operations and the measurement is defined as net income or loss excluding interest income, expense, income taxes, depreciation and amortization and certain other non-recurring or non-cash items.

正如安德魯所提到的，我們將調整後的EBITDA 視為一種非GAAP 財務指標，以更好地反映持續經營情況，該指標被定義為淨收入或虧損，不包括利息收入、費用、所得稅、折舊和攤銷以及某些其他非-經常性或非現金項目。

I'll refer you to the table in the news release or 10-Q we issued yesterday for a reconciliation of GAAP to non-GAAP financial measures.

我將向您推薦我們昨天發布的新聞稿或 10-Q 中的表格，以了解 GAAP 與非 GAAP 財務指標的調整。

Now, I'll summarize our first half 2024 results. Total revenues were $15.8 million for the first half of 2024 compared with $14.6 million for the first half of 2023. This 8% increase was primarily driven by continued penetration and adoption of PDT within the AK markets.

現在，我將總結我們 2024 年上半年的業績。2024 年上半年的總收入為 1,580 萬美元，而 2023 年上半年的總收入為 1,460 萬美元。8% 的成長主要是由於 PDT 在 AK 市場的持續滲透和採用。

Total operating expenses were $26.3 million for the first half of 2024 compared with $28.8 million for the first half of 2023. Cost of revenues increased from the prior year to $8.5 million for the first six months of 2024 compared to $7.5 million for the first half of 2023, again, due to our increased volume.

2024 年上半年的總營運費用為 2,630 萬美元，而 2023 年上半年為 2,880 萬美元。2024 年前六個月的收入成本較前一年增加至 850 萬美元，而 2023 年上半年的收入成本為 750 萬美元，這同樣是由於我們的銷售增加。

Selling, general and administrative expenses decreased to $17.2 million from $21.4 million in the prior year, again, primarily as we see benefits of continued cost control efforts and lower legal expenses compared to the first half of 2023. The net loss for the first half of 2024 was $10.7 million compared with a net loss of $17.3 million for the first half of 2023.

銷售、一般和管理費用從前一年的 2,140 萬美元減少至 1,720 萬美元，這主要是因為我們看到了持續的成本控制努力以及與 2023 年上半年相比較低的法律費用帶來的好處。2024 年上半年的淨虧損為 1,070 萬美元，而 2023 年上半年的淨虧損為 1,730 萬美元。

Adjusted EBITDA was negative $9.3 million for the first half of 2024 compared with negative $11.9 million for the first half of 2023. Again, please refer to the table in our 10-Q for a reconciliation between GAAP and non-GAAP financial measures.

2024 年上半年調整後 EBITDA 為負 930 萬美元，而 2023 年上半年為負 1,190 萬美元。同樣，請參閱我們 10-Q 中的表格，以了解 GAAP 和非 GAAP 財務指標之間的調整。

Okay. Now turning to our balance sheet as of June 30, 2024. We had cash and cash equivalents of $4.4 million compared with $1.3 million as of December 31, 2023. We have been focusing on account receivable collections and improving our production process, along with the expected summer seasonality of our business, we have reduced our AR from $5.2 million as of December 31, 2023, to $3.5 million as of June 30 of 2024.

好的。現在就來看看我們截至 2024 年 6 月 30 日的資產負債表。我們的現金和現金等價物為 440 萬美元，而截至 2023 年 12 月 31 日為 130 萬美元。我們一直專注於應收帳款催收和改進我們的生產流程，加上我們業務的預期夏季季節性，我們已將應收帳款從截至2023年12月31日的520萬美元減少到截至2024年6月30日的350萬美元。

As of July 10, we have extinguished our short-term debt obligation as well. We are continuing to burn through our inventory that Hermann mentioned a moment ago and we expect to have sold through this excess inventory in the next few months. As I mentioned before, we will hold safety stock but at a lower amount, which is within typical industry standards.

截至 7 月 10 日，我們也取消了短期債務。我們正在繼續消耗赫爾曼剛才提到的庫存，我們預計在未來幾個月內將多餘的庫存售罄。正如我之前提到的，我們將持有安全庫存，但數量較低，這在典型的行業標準範圍內。

Following an Ameluz recall in the first quarter, which was outside of our responsibility, we have received the three batches of replacement inventory in July from our supplier at no cost to us. In May, our stockholders approved an increase -- to increase our authorized common shares to $35 million.

在第一季 Ameluz 召回事件（這不屬於我們的責任範圍）之後，我們已於 7 月從供應商免費收到了三批替換庫存。5 月份，我們的股東批准了增資計劃，將我們的授權普通股增加至 3,500 萬美元。

Upon the stockholder approval, the redemption rights and preferred liquidation rights were eliminated for the Series B preferred and any remaining B1 preferred stock and any remaining B1 preferred stock automatically converted to Series B2 preferred stock.

經股東批​​准後，B系列優先股的贖回權和優先清算權被消除，任何剩餘的B1優先股和任何剩餘的B1優先股將自動轉換為B2系列優先股。

As a result, of these changes to the rights and preferences all Series B convertible preferred stock was reclassified from mezzanine to permanent equity. On May 13 and 14, 2024, 7,998 preferred warrants were exercised to purchase shares of the company's B3 convertible preferred stock from which net proceeds were $7.4 million. As a result of the Series B convertible preferred stock reclass to permanent equity, along with the warrant exercise, our shareholders' equity increased to $10.9 million as of June 30, 2024.

因此，在這些權利和優先權的變化中，所有 B 系列可轉換優先股都從夾層重新分類為永久股權。2024年5月13日至14日，7,998張優先認股權證被行使，以購買該公司的B3可轉換優先股，所得淨收益為740萬美元。由於 B 系列可轉換優先股重新分類為永久股權，加上認股權證的行使，截至 2024 年 6 月 30 日，我們的股東權益增加至 1,090 萬美元。

Finally, I would like to comment on our capital structure and walk you through what management considers to be the fully diluted common share total. As of August 12, we had 5.5 million common shares outstanding. The B1 and B3 convertible preferred shares could convert to 17.7 million common shares.

最後，我想評論一下我們的資本結構，並引導您了解管理層認為的完全稀釋普通股總額。截至 8 月 12 日，我們已發行普通股 550 萬股。B1和B3可轉換優先股可轉換為1770萬股普通股。

Our warrants, if exercised, would equate to 2.3 million common shares. I will note that of these warrants, 77,000 warrant shares are significantly out of the money with a strike price of $100. The more recent warrants all have a strike price of $3.55 and equate to 2.2 million common shares if exercised.

若行使，我們的認股權證將相當於 230 萬股普通股。我要指出的是，在這些認股權證中，有 77,000 股認股權證的執行價為 100 美元，明顯處於價外狀態。最近的認股權證的執行價格均為 3.55 美元，如果行使，相當於 220 萬股普通股。

Finally, common shares converted by awards under our Omnibus plan totaled 1.8 million common shares if all awards are realized and exercised. As such, management believes our fully diluted common is approximately 27.3 million shares.

最後，如果所有獎勵均已兌現並行使，根據我們的綜合計劃透過獎勵轉換的普通股總計為 180 萬股普通股。因此，管理階層認為我們完全稀釋後的普通股約為 2,730 萬股。

So with that overview of our business and recent financial performance, Hermann and I are now ready to take questions from our covering analysts. Operator?

因此，在對我們的業務和最近的財務表現進行了概述之後，赫爾曼和我現在準備好回答我們的覆蓋分析師的問題。操作員？

(Operator Instructions) Jonathan Aschoff, ROTH.

（操作員說明）Jonathan Aschoff，ROTH。

Thank you. Good morning, guys. I was curious if I could just drill down on a quarter for sales of each type of land the second quarter and so far in this quarter. Can you give me four numbers, each type of lamp, how many you placed second quarter and so far in the third quarter?

謝謝。早安，夥計們。我很好奇是否可以深入了解第二季和本季迄今為止每種類型土地的銷售情況。你能給我四個數字，每種類型的燈，你在第二季度和第三季度到目前為止放置了多少個？

In the second quarter, we placed 57 of the original lamps, and we placed in the last weeks of June, we shipped four of the XL lamps. We haven't published anything on the third quarter.

在第二季度，我們放置了 57 個原始燈，在 6 月的最後幾週，我們發貨了四個 XL 燈。我們尚未發布任何有關第三季度的信息。

That's no problem. What would be the price hike percentage on October 1?

那沒問題。10月1日漲價百分比是多少？

Price increase for Ameluz will be 5%.

Ameluz 的價格將上漲 5%。

Got it. Thank you. And by the way, for the acne and the AK extremity trial, do you still expect to publicly release data when you originally said in mid-'25 and second half '25, respectively, for acne and AK. Is that still holding?

知道了。謝謝。順便說一句，對於痤瘡和 AK 肢體試驗，您最初表示分別在 25 年中期和 25 年下半年分別公開痤瘡和 AK 的數據嗎？那還堅持著嗎？

Yeah, it will be second half of 25% for both of them.

是的，對他們倆來說，這將是 25% 的下半年。

Okay. That's very helpful. So when will the royalty savings from the renegotiated LSA become higher than the costs of the trials. When does that whole LSA redo turn positive for you?

好的。這非常有幫助。那麼，重新談判的 LSA 所節省的特許權使用費何時會高於試驗成本。整個 LSA 重做什麼時候對你來說會變得正面？

Yeah. So that's obviously attached to our ordering of inventory, which we will start to do in the fourth quarter of 2024. And then depending on when the shipments come in and everything either late Q1 or early Q2, we'll sort of flip and have more savings than we spent on the clinical trials.

是的。因此，這顯然與我們的庫存訂購有關，我們將於 2024 年第四季開始進行庫存訂購。然後，根據發貨時間以及第一季末或第二季初的所有情況，我們會進行翻轉，節省的費用比臨床試驗上的花費還要多。

Okay. And lastly, is there any update on the timing of that low-cost portable lamp development? Or even what has just happened irrespective of timing?

好的。最後，低成本便攜式燈的開發時間有更新嗎？或甚至無論時間如何剛剛發生了什麼？

Well, we are nearing a first prototype and after that, we have to go into a more formal development according to the design control rules of the FDA.

好吧，我們即將推出第一個原型，之後，我們必須根據 FDA 的設計控制規則進行更正式的開發。

All right. That’s all I had. Thank you very much.

好的。這就是我所擁有的一切。非常感謝。

Bruce Jackson, Benchmark Company.

布魯斯傑克遜，基準公司。

Hi, good morning. And thank you for taking my questions. I wanted to look at the sales numbers for the quarter in a little bit more detail. Generally, the second quarter is seasonally a little bit weaker than the rest of them.

嗨，早安。感謝您回答我的問題。我想更詳細地了解該季度的銷售數據。一般來說，第二季的季節性比其他季度弱一些。

And I'm kind of curious to know with the ordering patterns, how much of the results in the quarter were a rebound because of the change health incident? And how much of that is organic growth? And then the second part of that question would be, looking forward, how do you expect the rest of the year Q1 play out in terms of seasonality?

我很好奇，從訂購模式來看，本季的業績有多少是因為健康變化事件而反彈的？其中有多少是有機成長？然後這個問題的第二部分是，展望未來，您預計今年第一季剩餘時間的季節性情況如何？

Most of the rebound we had in April. So we can consider the May and June already more or less a normal month. And in all three months, we had significant growth compared to last year. So I would -- if I had to guess, I would think that this is really a guess. We can't give you any real numbers on this. But at most, half is a rebound effect.

大部分反彈是在四月發生的。所以我們可以認為五月和六月已經或多或少是一個正常的月份。在這三個月裡，與去年相比，我們有了顯著的成長。所以我會——如果我必須猜測，我會認為這確實是一個猜測。我們無法給你任何關於這方面的真實數字。但頂多有一半是反彈效應。

Okay. And then in terms of the R&D spend going forward, is that going to -- what's the run rate on the R&D expense going to be, do you think, for the next couple of quarters?

好的。那麼就未來的研發支出而言，您認為未來幾季的研發支出運作率會是多少？

Yeah. Hermann, I can take that. So we're expecting to spend a couple -- so we took over clinical trials on June 1, as Hermann mentioned. And as far as the run rate here, we were expecting two points spending about $2.4 million or so this year in R&D spend.

是的。赫爾曼，我可以接受。因此，我們預計會花費一些資金，因此正如赫爾曼所提到的那樣，我們在 6 月 1 日接管了臨床試驗。就運行率而言，我們預計今年的研發支出約為 240 萬美元左右，為 2 個百分點。

So that's for the entire year.

這就是全年的情況。

That is correct.

這是正確的。

From June 1. So then we'll be looking at -- Okay, I got it.

從 6 月 1 日起。那我們會看看——好吧，我明白了。

Yeah, we have, I would say, maybe $1 million each quarter. I think as of right now, we believe it's going to be used, but that does depend on the recruiting and if there are a pop there, et cetera. So -- but we do think that it's -- over the next six months, it will be somewhere in that ballpark.

是的，我想說，我們每季可能有 100 萬美元。我認為截至目前，我們相信它將被使用，但這確實取決於招募情況以及是否有流行等。所以——但我們確實認為——在接下來的六個月裡，它將在這個範圍內的某個地方。

Okay. And then you mentioned the data from the AK and the acne trials -- the extremity and the acne trials in the second half with the basal cell carcinoma, are you going to be releasing data on that as well?

好的。然後你提到了 AK 和痤瘡試驗的數據——下半年的四肢和基底細胞癌痤瘡試驗，你也會發布這方面的數據嗎？

Yes. We will release -- we expect to be able to release data from the clinical trial -- clinical part of the BCC trial still this year and then the follow-up part in the first half of next year.

是的。我們預計今年仍將發布（我們預計能夠發布臨床試驗的數據）BCC 試驗的臨床部分，然後在明年上半年發布後續部分。

Okay. All right, great. That’s it for me. Thank you.

好的。好吧，太好了。我就是這樣。謝謝。

This concludes our question-and-answer session. I would like to turn the conference back over to Hermann Luebbert for any closing remarks.

我們的問答環節到此結束。我想將會議轉回給赫爾曼·呂伯特（Hermann Luebbert）發表閉幕詞。

Yeah. Thank you, operator. The second quarter and first half of the year has been a thriving and very encouraging time for us with a significant growth in our revenues. I would like all of you to participate in this call, and I would also take the opportunity to thank all our employees for the tremendous effort that went into this process. We look forward to speaking with you then when we report our third quarter 2024 results. Thank you, and have a nice day.

是的。謝謝你，接線生。今年第二季和上半年對我們來說是一個蓬勃發展且非常令人鼓舞的時期，我們的收入顯著成長。我希望你們所有人都參加這次電話會議，我也想藉此機會感謝我們所有的員工在過程中付出的巨大努力。我們期待在報告 2024 年第三季業績時與您交談。謝謝你，祝你有美好的一天。

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

會議現已結束。感謝您參加今天的演講。您現在可以斷開連線。