美國
證券 交易委員會
華盛頓, D.C. 20549
表格
(標記 一個)
| 每季度 根據1934年《證券交易法》第13或15（d）條提交的報告 |
截至
季度期間
或
| 過渡 根據1934年《證券交易法》第13或15（d）條提交的報告 |
對於 從到的過渡期
委員會
案件編號
(根據公司章程所述的註冊人的正確名稱)
（註冊地點或其他管轄區的州份 註冊或組織） |
（國稅局雇主 識別號碼） | |
| （總執行辦公室地址） | （郵政編碼） |
（申報人的電話號碼，包括區號）
(如有更改，請填寫更改前的名稱、地址和財政年度)
根據該法案第12(b)條紀錄的證券：
| 每個類別的標題 | 交易標誌 | 在哪個交易所上市的名字 | ||
| Preferred 股票購買權 | 納斯達克股票市場有限責任公司 | |||
勾選表示公司已按照證券交易法第13或15(d)條款的規定，在過去12個月（或公司需要提交此類報告的較短期限內）提交了所有所需的報告；並且公司在過去90天內一直受到此類提交報告的要求。
請用勾選框表示，是否本登記人在過去12個月內（或本登記人應遞交此類文件的較短期間內）按照S-t條例第405條的規定，已經以電子方式提交每一份所需提交的互動資料檔案。
請勾選以下選項，指明掛牌者是否為大型快速申報掛牌者、快速申報掛牌者、非快速申報掛牌者、較小型的報告公司或新興成長型公司。關於Exchange Act第1202條中「大型快速申報掛牌者」、「快速申報掛牌者」、「較小型報告公司」和「新興成長型公司」的定義，請參閱。
| 大型及加速提交者 | ☐ | 加速提交者 | ☐ |
| ☒ | 較小的報告公司 | ||
| 新興成長型公司 |
如為新興成長企業，則應打勾選項表示申報人已選擇不使用交易所法第13(a)條所提供的任何新或修訂財務會計準則延長過渡期遵守。
請勾選是否登記者為外殼公司（依照交易所法規120億2的定義）。是 ☐ 否
截至2024年11月12日，登記公司普通股尚有 股。 。
目錄
| 第一部分. 財務資訊 | ||
| 項目 1. | 基本報表 | 3 |
| 2024年9月30日（未經審核）和2023年12月31日的總合資產負債表 | 3 | |
| 截至2024年9月30日的三個月和九個月未經審核的簡明綜合營運報表和2023年未經審核的簡明綜合營運報表 | 4 | |
| 截至2024年9月30日的三個月和九個月未經審核的簡明綜合股東權益報表和2023年未經審核的簡明綜合股東權益報表 | 5 | |
| 截至2024年9月30日的九個月未經審核的簡明綜合現金流量表和2023年未經審核的簡明綜合現金流量表 | 6 | |
| 附註至簡明綜合財務報表 | 7 | |
| 項目 2. | 管理層對財務狀況和業績的討論與分析 | 24 |
| 項目 3. | 市場風險的定量和定性披露。 | 36 |
| 項目 4. | 內部控制及程序 | 36 |
| 第二部分。其他資訊 | ||
| 項目 1. | 法律訴訟 | 37 |
| 項目 1A。 | 風險因素 | 37 |
| 項目2。 | 股票權益的未註冊銷售和資金用途 | 37 |
| 項目3。 | 優先證券違約 | 37 |
| 項目4。 | 礦業安全披露 | 37 |
| 項目5。 | 其他資訊 | 37 |
| 項目6。 | 展品 | 38 |
| 簽名 | 39 | |
| 2 |
第一部分 財務資訊
項目 1. 基本報表
BIOFRONTERA INC.
簡明合併資產負債表
(在 千位數中，除了面值和分享金額)
9月30日， 2024 | 十二月三十一日， 2023 | |||||||
| (未經審核) | ||||||||
| 資產 | ||||||||
| 流動資產: | ||||||||
| 現金及現金等價物 | $ | $ | ||||||
| 投資, 關聯方 | ||||||||
| 應收帳款，淨額 | ||||||||
| 存貨，淨額 | ||||||||
| 預付費用及其他流動資產 | ||||||||
| 待售資產 | ||||||||
| 其他資產，關係人 | ||||||||
| 流動資產總額 | ||||||||
| 不動產及設備，淨額 | ||||||||
| 營運租賃使用權資產 | ||||||||
| 無形資產，淨值 | ||||||||
| 其他資產 | ||||||||
| 總資產 | $ | $ | ||||||
| 負債及股東權益 | ||||||||
| 流動負債： | ||||||||
| 應付帳款 | ||||||||
| 與關係方應付帳款 | ||||||||
| 租賃負債 | ||||||||
| 應計費用及其他流動負債 | ||||||||
| 短期負債 | ||||||||
| 流動負債總額 | ||||||||
| 長期負債： | ||||||||
| 認股權證負債 | ||||||||
| 營運租賃負債，非流動 | ||||||||
| 其他負債 | ||||||||
| 總負債 | ||||||||
| 承諾和條件（註17） | ||||||||
| 股東權益： | ||||||||
| B系列可轉換優先股，$ 面值， 授權股份數， B-1系列 B-2系列和 Series b-3 shares issued and outstanding as of September 30, 2024 and 截至2023年12月31日，已發行並流通的股份數量。 | ||||||||
| 0.01 par value, 授權的股份； 和 截至2024年9月30日和2023年12月31日，已發行並流通股份分別為 | ||||||||
| 資本公積額額外增資 | ||||||||
| 累積虧損 | ( | ) | ( | ) | ||||
| 股東權益總額 | ||||||||
| 負債和股東權益總額 | $ | $ | ||||||
附帶附註是這些簡明綜合財務報表中不可或缺的一部分。
| 3 |
BIOFRONTERA INC.
綜合損益表
(以千為單位，除每股金額及股份數目外)
(未經審核)
結束的三個月 九月三十日， | 九個月結束 九月三十日， | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| 產品收入淨額 | $ | $ | $ | $ | ||||||||||||
| 收入，關係方 | ||||||||||||||||
| 總收入淨額 | ||||||||||||||||
| 營運費用 | ||||||||||||||||
| 關聯方營收成本 | ||||||||||||||||
| 其他營收成本 | ||||||||||||||||
| 銷售、一般及行政 | ||||||||||||||||
| 銷售、總部和行政費用，關聯方 | ||||||||||||||||
| 研發 | ||||||||||||||||
| 或有對價的公允價值變化 | ||||||||||||||||
| 營業費用總額 | ||||||||||||||||
| 營運虧損 | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| 其他收入（費用） | ||||||||||||||||
| 認股權証變動公允價值之變動 | ( | ) | ||||||||||||||
| 投資公平值變動，相關方 | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| 債務清償損失 | ( | ) | ||||||||||||||
| 利息收入（費用），淨額 | ( | ) | ( | ) | ( | ) | ||||||||||
| 其他收入（費用），淨額 | ( | ) | ||||||||||||||
| 其他總費用 | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| 稅前損失 | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| 所得稅費用 | ||||||||||||||||
| 淨損失 | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| 每普通股份損失： | ||||||||||||||||
| 基本和稀釋 | $ | ) | $ | ) | $ | ) | $ | ) | ||||||||
| 加權平均在外流通股數： | ||||||||||||||||
| 基本及稀釋 | ||||||||||||||||
附註是這些簡明綜合財務報表的不可分割部分。
| 4 |
BIOFRONTERA INC.
總結財務狀況表
(以千為單位，除股份數量之外)
(未經審核)
| 截至2024年9月30日止三個和九個月的精簡綜合股東權益報表 | ||||||||||||||||||||||||||||
| 優先股 | 普通股 | 追加 實收資本 | 累積 | |||||||||||||||||||||||||
| 股份 | 金額 | 股份 | 金額 | 資本 | 赤字 | 總計 | ||||||||||||||||||||||
| 2024年7月1日結餘 | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||||||
| 將B系列優先股轉換為普通股 | ( | ) | ( | ) | ||||||||||||||||||||||||
| 以股票為基礎的補償 | - | - | ||||||||||||||||||||||||||
| 淨損失 | - | - | ( | ) | ( | ) | ||||||||||||||||||||||
| 2024年9月30日餘額 | $ | $ | $ | ( | ) | $ | ||||||||||||||||||||||
| 2024年1月1日的餘額 | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||||||
| 行使預先資助的認股權證 | - | ( | ) | |||||||||||||||||||||||||
| 將系列b-1優先股轉換為系列b-2優先股和普通股 | ||||||||||||||||||||||||||||
| 行使warrants時發行系列b-3 | - | |||||||||||||||||||||||||||
| 發行RSU | - | |||||||||||||||||||||||||||
| 基於股票的補償 | - | - | ||||||||||||||||||||||||||
| 淨虧損 | - | - | ( | ) | ( | ) | ||||||||||||||||||||||
| 截至2024年9月30日的餘額 | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||||||
| 截至2023年9月30日的三個月和九個月 | ||||||||||||||||||||
| 普通股 | 追加 已付資本 | 累積 | ||||||||||||||||||
| 股份 | 金額 | 資本 | 赤字 | 總計 | ||||||||||||||||
| 2023年7月1日結存 | $ | | $ | $ | ( | ) | $ | |||||||||||||
| 進行股票逆向拆股（針對碎股的發行） | ||||||||||||||||||||
| 以股票為基礎的補償 | - | |||||||||||||||||||
| 淨損失 | - | ( | ) | ( | ) | |||||||||||||||
| 2023年9月30日的餘額 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| 2023年1月1日的結餘 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| 發行股票以支付已發放的限制性股票單位 | ||||||||||||||||||||
| 進行股票逆向拆股（針對碎股的發行） | ||||||||||||||||||||
| 以股票為基礎的補償 | - | |||||||||||||||||||
| 淨損失 | - | ( | ) | ( | ) | |||||||||||||||
| 2023年9月30日的餘額 | $ | $ | $ | ( | ) | $ | ||||||||||||||
附註是這些簡明綜合財務報表的不可分割部分。
| 5 |
BIOFRONTERA INC.
綜合現金流量表
(以千計)
(未經審核)
| 截至九月三十日的九個月。 | ||||||||
| 2024 | 2023 | |||||||
| 經營活動現金流量： | ||||||||
| 淨損失 | $ | ( | ) | $ | ( | ) | ||
| 調整使淨損失與經營活動中使用之現金流量相符： | ||||||||
| 折舊 | ||||||||
| 租賃權資產攤銷 | ||||||||
| 收購無形資產的攤銷 | ||||||||
| 與關聯方投資有關的實現/未實現損失 | ||||||||
| 或有對價的公允價值變化 | ||||||||
| 認股權證負債公平價值變動 | ( | ) | ( | ) | ||||
| 股票為基礎的補償 | ||||||||
| 信用損失準備 | ||||||||
| 債務清償損失 | ||||||||
| 非現金利息費用 | ||||||||
| 營運資產和負債的變化： | ||||||||
| 應收賬款 | ( | ) | ||||||
| 其他應收款，關聯方 | ||||||||
| 預付費用及其他資產 | ||||||||
| 其他資產，關係人 | ||||||||
| 存貨 | ( | ) | ||||||
| 應付帳款及關聯方應付款 | ( | ) | ||||||
| 租賃負債 | ( | ) | ( | ) | ||||
| 應計費用及其他負債 | ||||||||
| 經營活動使用的現金流量 | ( | ) | ( | ) | ||||
| 投資活動產生的現金流量 | ||||||||
| 關係人之股本投資銷售 | ||||||||
| 購置無形資產 | ( | ) | ||||||
| 購置財產及設備 | ( | ) | ( | ) | ||||
| 投資活動提供的現金流量（增加）減少 | ( | ) | ||||||
| 財務活動中的現金流量 | ||||||||
| 發行B-1優先股及購買B-3優先股認股權淨額 | ||||||||
| 從認股權行使中發行B-3優先股的收益 | ||||||||
| 來自信用額度的收益 | ||||||||
| 對信貸額度之還款 | ( | ) | ( | ) | ||||
| 支付主要短期債務本金 | ( | ) | ||||||
| 融資活動所提供的現金流量 | ||||||||
| 現金及現金等價物的淨增加（減少） | ( | ) | ||||||
| 期初的現金、現金等價物和限制性現金 | ||||||||
| 期末的現金、現金等價物和限制性現金 | $ | $ | ||||||
| 現金流額外披露 | ||||||||
| 支付利息 | $ | $ | ||||||
| 支付的利息，相關方 | $ | $ | ||||||
| 所支付的所得稅淨額 | $ | $ | ||||||
| 補充非現金融資活動 | ||||||||
| 將認股權負債轉換為權益 | ||||||||
| 以賃賦租賃負債交換新增的使用權資產 | $ | $ | ||||||
附註是這些簡明綜合財務報表的不可分割部分。
| 6 |
Biofrontera 公司
注意事項 至簡明綜合財務報表
(未經審核)
1. 組織和業務概況
Biofrontera Inc.，一家德拉瓦州公司（以下簡稱“公司”或“Biofrontera”），是一家總部位於美國的生物藥品公司，專注於商業化一系列用於治療皮膚疾病的藥品產品，特別是光動力療法（“PDT”）和局部抗生素。 公司許可的產品用於治療劣性角化症（“AKs”），這是一種預癌性皮膚病變，以及膿炎，一種細菌性皮膚感染。
該公司包括其全資子公司Biofrontera Discovery GmbH（“Discovery”），前身為Bio-FRI GmbH，該公司成立於2022年2月9日，根據德國法律成立的有限責任公司，作為德國的機構，負責管理我們的臨床試驗工作並促進我們與Biofrontera Pharma GmbH（“Biofrontera Pharma”）和Biofrontera Bioscience GmbH（“Biofrontera Bioscience”和Biofrontera Pharma合稱為“Ameluz授權方”）之間的關係，這兩家公司均是Biofrontera AG的全資子公司，該公司持有該公司超過五％的普通股。
我們的 主要許可產品是Ameluz®，這是一種被批准與PDt結合使用的處方藥（當與“Ameluz® PDT”一起使用）使用BF-RhodoLED® 和RhodoLED® XL 燈具（以下稱「RhodoLED燈具」）。在美國，光敏治療（PDt）用於面部和頭皮輕度至中度的日光性角化病的病變導向和區域導向治療。® 我們目前在美國根據獨家授權和供應協議，銷售Ameluz，該協議為第二次修訂和重新制定的授權及供應協議，於2024年2月13日生效（以下稱「第二次A&R Ameluz LSA」）。® 該協議與Ameluz授權方簽訂。
我們的 第二個處方藥許可產品是Xepi® （ozanoxacin乳膏，1%），這是一種不含氟的局部喹諾酮，能 抑制細菌生長。目前，對Xepi的抗生素支撐位尚不為人知® ，且已獲得食品和藥物管理局（“FDA”）的特別批准，用於治療由 金黃色葡萄球菌或鏈球菌引起的常見皮膚感染——膿皰病。它已在美國獲准用於2個月及 以上的成年人和兒童。我們與Ferrer Internacional S.A. （“Ferrer”）的獨家許可和供應協議（修訂版）（“Xepi LSA”），通過我們於2019年3月25日收購Cutanea Life Sciences, Inc. （“Cutanea”）被公司承接，使公司能夠在美國市場上推廣和賣出這個產品。由於第三方製造延遲，該公司從Xepi的銷售中產生的營業收入有限，影響了我們的產品商業化。Ferrer 目前正在培訓一個新的合同製造商。如果新的合同製造商取得資質，我們相信它將能夠供應足夠的Xepi® 產品線，以滿足市場需求，只要我們保持它的存在。
然而， 在2024年第三季度，公司做出決定剝離其Xepi產品線並認定其符合 待售資產的會計標準。公司已簽署意向書， 並預計在未來六到十二個月內完成銷售。相關的無形資產被列為待售資產 在簡明合併資產負債表中的流動資產下。見 第7條。待售資產，以獲取更多 信息。
流動性 和持續經營能力
根據財務會計準則委員會（FASB）會計準則編碼（“ASC”）主題205-40的要求，關於實體是否能夠繼續作為營業往來的不確定性披露，管理層必須評估是否存在條件或事件，綜合考慮，對公司能夠繼續作為營業往來感到重大疑慮，時間跨度為自合併基本報表發布之日算起的一年。這一評估不考慮管理層未完全實施或公司無法控制的計劃可能具有的緩解效應，該效應是指管理層計劃的緩解效應足以減輕對公司能夠繼續作為營業往來的重大疑慮。然而，只有在以下兩種情況均具備時，才會考慮管理層計劃的緩解效應：（1）計劃有可能在合併基本報表發布後一年內得以有效實施，以及（2）在實施後，計劃有可能減輕導致對實體能夠在合併基本報表發布後一年內繼續作為營業往來提出重大疑慮的相關條件或事件。
| 7 |
自2015年開始運營以來，我們已經產生了巨額虧損。我們從運營中的淨現金流出額累計$
由於我們的虧損和預計的現金需求，公司管理層確定在基本報表發行之日起的至少十二個月內，我們是否能繼續作為持續經營存在著重大疑慮。公司作為持續經營的能力取決於管理層在接下來十二個月內成功執行計劃以改善公司的流動性和盈利能力，包括但不限於：
| · | 擴大Ameluz的商業化® 在美國同時減少自由支出。 | |
| · | 透過發行股權證券、債務或出售資產來積極尋求額外資本。 | |
| · | 控制費用並限制資本支出。 | |
| · | 根據第二次A&R Ameluz LSA的條款，實現減少庫存成本的好處。 |
管理層認為實施這些計劃將為公司提供繼續作為一個持續經營的機會。然而，在這些努力中公司能否成功並無法保證，實質懷疑將被減輕。
附帶的基本報表已按持續經營原則編製，該原則考慮了資產的實現和業務正常進行中的負債償還。基本報表未包括與記錄的資產金額的回收性和分類，或可能導致由上述不確定性的結果所產生的負債金額和分類的任何調整。
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2. 主要會計政策摘要
基本報表編製依據
本公司附帶的未經審計的中期簡報合併基本報表是根據證券交易委員會（"SEC"）對中期財務報告的規則和條例編制的。根據這些規則和條例，通常包含在根據美國公認會計原則（"U.S. GAAP"）編制的年度基本報表中的某些信息和註腳披露已被簡化或省略。在本公司看來，這些未經審計的簡約合併基本報表包括所有重要調整，所有調整均為正常且經常性的，這些調整對於公正地呈現本公司截至2024年9月30日的財務狀況、截至2024年和2023年9月30日的三個和九個月的經營成果，以及截至2024年和2023年9月30日的九個月的現金流量是必要的。截止2023年12月31日的附帶財務信息來源於經審計的基本報表。中期結果不一定能指示全年的結果。本季度報告的內容應與本公司為截至2023年12月31日提交給SEC的10-K表格的年度報告一起閱讀，該報告於2024年3月15日提交。
該公司只有一個應報告的板塊。此基本報表和表格中所示的所有金額均為千元，而註解中的金額則為百萬元，除了百分比、每股以及股份金額。
除了以下的會計政策外，至2023年12月31日止年度的公司10-K表格中討論的重大會計政策沒有任何新情況或重大變更。
資產 待售
當符合以下條件時，公司一般會考慮資產被持有以出售：(i) 管理層承諾出售計劃 資產、(ii) 資產可立即出售、(iii) 管理層已啟動積極計劃尋找買家 或完成出售資產計劃所需的買方和其他行動，(iv) 在一年內出售資產是 被視為可能，(v) 資產正在積極以與目前交易所相對合理的價格進行銷售 預計價值和 (vi) 出售計劃不會有重大變化。分類為持有待售的資產不再折舊 並按照以較低的帳面價值或公平價值減去銷售的估計成本報告 阿斯克 360、物業、工廠及設備 － 長期資產的減值或出售。請參閱註 7.
研究 和開發成本
研究和發展費用包括直接與Ameluz臨床開發相關的成本。®包括與人員相關的費用，外部承包商提供的服務費用（包括與公司臨床試驗相關的服務）、設施費用、折舊費用以及其他直接和分攤的費用。所有與研究和開發相關的成本均按發生時支出。
臨床 試驗成本是我們研究和開發費用的一個重要組成部分，包括與第三方承包商相關的成本。 本公司外包了相當大一部分的臨床試驗活動，利用外部實體如臨床研究 組織、獨立臨床研究人員及其他第三方服務供應商來協助本公司 執行其臨床試驗。我們對這些合約下的預估成本進行預提。評估預提負債的充足性時，我們分析研究或臨床試驗的進展，包括事件的階段或完成情況、收到的發票、合約成本及採購訂單。在確定任何報告期末的預提餘額時，會根據當時已知的事實和情況作出重大的判斷和估計。儘管我們不預期這些估計與實際支出數額會有重大差異，但如果服務執行的狀態和時序的估計與實際的狀態和時序不符，我們可能會在特定期間報告過高或過低的金額。實際結果可能會與我們的估計有所不同。如果未來的實際結果與公司的估計出現差異，本公司將會調整這些估計，並在變異發生的時期記錄任何必要的調整。在收到相關服務之前，根據這些安排提前支付的款項會被記錄為預付費用，直到服務提供完成。
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使用估計值
根據美國通用會計準則準備基本報表需要管理層使用估計和假設，這些假設影響資產和負債的報告金額，以及披露財務報表日報告的應計資產和負債金額，以及報告期間產生的收入和費用金額。合適使用假設、估計和判斷的主要領域包括應收款項和存貨賬面值減損、認股權責任、無形及其他長期資產的實現、產品銷售津貼和備用金、股份支付、研究開發費用及所得稅的應計，包括處置所得稅資產和負債。估計是基於歷史經驗和其他在情況下被視為適當的假設。它們不斷被審查，但可能與實際值有所不同。
最近發布的會計準則
在2023年的11月，FASB發佈了ASU 2023-07， 改善可報告部門披露. 此標準更新要求額外的 中期和年度披露關於可報告部門的支出，即使是對於只有一個可報告部門的公司。該 公司必須在2024年度報告中採納該指導，並以表格10-K提交，雖然允許提前採用。該公司 目前正在評估這些修訂對其披露的影響，但這一標準更新不會影響公司的 經營結果或財務狀況。
2023年12月，FASB發布了ASU 2023-09《所得稅（主題740）-》。 所得稅揭露的改進ASU要求實體在有效稅率調和表中披露特定類別，並提供用於調和符合定量閾值的項目的額外資訊。此外，ASU還要求披露州所支出的稅收與聯邦所支出的所得稅開支。該ASU中的修訂須於2024年12月15日後採納。可提前採納，修訂須應用於前瞻性基礎上。我們目前正在評估採用ASU對我們披露的影響。
3. Fair Value Measurements
下表列出了截至2024年9月30日和2023年12月31日針對公司資產在定期基礎上以公允價值衡量的資訊，並指明公司所使用的估值輸入的公允價值層級，以判斷該公允價值：
| （以千為單位) | 級別 | 九月三十日， 2024 | 12月31日, 2023 | |||||||
| 資產： | ||||||||||
| 投資, 關聯方 | 1 | $ | $ | |||||||
| 負債： | ||||||||||
| 賠償負債－2022年購股權 | 3 | $ | $ | |||||||
| 2022年誘因認股權負債 | 3 | $ | $ | |||||||
| 2023年購買認股權負債 | 3 | $ | $ | |||||||
| 總負債 | $ | $ | ||||||||
| 10 |
投資，相關方
截至2024年9月30日和2023年12月31日，該公司作為投資持有 （經調整後，於2024年5月14日進行了股票逆向拆分）和 ，分別持有Biofrontera, AG的普通股，該公司持有我們普通股超過五％，並在法蘭克福證券交易所上市。通過參考市場報價，這些投資的公允價值是通過一級輸入量確定的。
認股權證 負債
這些
warrants負債包含(i) 在2022年5月16日通過私募發行的未償還warrants，用於購買
2022年購買warrants、2022年誘導warrants及2023年購買warrants被列作負債，因為這些warrants 提供在根本交易的情況下可贖回的權利，而該根本交易未滿足ASC 815-40下的指數指導要求。warrants負債在每個資產負債表日期重新計量，直到其行使或到期，任何公允價值的變動將在公司的合併營運報表中確認。
2022 年第 3 級購買認股權證、2022 年鼓勵認股權證及 2023 年購買認股認股權證的公平價值以黑色史考爾斯-默頓計算
（「BSM」）模型。我們的 BSm 模型中使用的某些輸入可能會根據以外的因素在未來期間波動
本公司的控制權。在計算公平價值時使用的一或多個輸入的重大變化可能會導致
我們認股證負債的公平價值發生重大變化，這也可能導致報告重大非現金收益或虧損
在我們的綜合運營報表中。這些認股權證的公平價值是以 BsM 期權定價模式為基礎來確定
基於截至 2024 年 9 月 30 日止的三個月和九個月的以下假設：相關普通股為 $ 的公平價值
到 $, 預期波動率
這
warrants 用於購買
BSm模型在2024年2月22日發行日期、2024年3月31日三個月結束和2024年5月13日行使日期使用以下輸入和假設的2024優先認股權，(i) 預期股價波動率區間為
以下表格顯示以公允價值計量的第三級權證負債的變化（以千計）:
九個月結束 九月三十日， | ||||||||
| 2024 | 2023 | |||||||
| 期初公允價值 | $ | $ | ||||||
| 發行新warrants | ||||||||
| 認購權證的行使 | ( | ) | ||||||
| 認股權證負債公平價值變動 | ( | ) | ( | ) | ||||
| 期末公允價值 | $ | $ | ||||||
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4. 營業收入
我們主要通過授權產品Ameluz的銷售來獲得營業收入。® 和RhodoLED燈。® 銷售我們的燈具帶來的營業收入相對微不足道，與通過銷售Ameluz獲得的營業收入相比。®.
相關方營業收入涉及與Biofrontera Bioscience達成的BF-RhodoLED協議。® 與臨床燈具相關的租賃和安裝服務，由於A＆R Ameluz LSA第二部分在2024年9月30日已不再生效。請參見 附註11，相關方交易.
以下是產品營業收入折讓和儲備變化分析摘要：
| （以千為單位）： | 回報 | 共同支付 援助計劃 | 提示 支付折扣 | 政府 以及支付者回扣 | 總計 | |||||||||||||||
| 2022年12月31日結餘 | $ | $ | $ | $ | $ | |||||||||||||||
| 與當期銷售有關的提供 | ||||||||||||||||||||
| 信貸或在期間內付款 | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||
| 2023年9月30日的結餘 | $ | $ | $ | $ | $ | |||||||||||||||
| 截至2023年12月31日的餘額 | $ | $ | $ | $ | $ | |||||||||||||||
| 與當期銷售有關的提供 | ||||||||||||||||||||
| 在期間內進行的信貸或付款 | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||
| 2024年9月30日的賬面 | $ | |||||||||||||||||||
5. 應收帳款淨額
應收賬款主要歸因於Ameluz的銷售®. 預計所有交易應收賬款將在資產負債表日期的十二個月內結清。交易應收賬款以其淨可實現價值計算。壞帳準備反映我們對應收款項預期壞帳的最佳估計，該估計基於歷史經驗和當前信息。在制定預期壞帳的估計時，交易應收賬款根據主要的逾期狀況劃分為不同的資產池，並為每一個交易應收賬款池建立固定的準備金百分比。
在決定每個交易賬款池的準備金百分比時，我們考慮了與特定客戶的歷史經驗、監管和法律環境以及其他相關的目前和未來預測的宏觀經濟因素。如果我們得知任何影響信用風險的特定客戶因素，我們將記錄這些已知有困難賬戶的特定撥備。
信貸損失準備金為 $
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6. 存貨
存貨 由Ameluz組成® 和RhodoLED® 燈具。
有
一個 截至2024年和2023年9月30日結束的三個月和九個月，關於陳舊的備供諾言的記錄。截至2023年12月31日，關於Ameluz特許人的自願召回，我們記錄了3000萬美元的存貨報銷，對應資產是預期從特許人轉為其他資產的相關方，因為Ameluz產品的召回批次將根據Ameluz特許證書和供應協議（“Ameluz LSA”）在Ameluz特許人免費更換。截至2024年7月23日，我們已經收到了回收的Ameluz替換庫存的全額款項。
7. 待售資產
資產 待售包括以下項目：
| （以千為單位) | 九月三十日， 2024 | 12月31日, 2023 | ||||||
| Xepi® 許可證 | $ | $ | ||||||
| 減：已提撥攤提 | $ | ( | ) | $ | ||||
| 待售資產 | $ | $ | ||||||
The
Xepi® 無形資產許可被記錄為收購當日公允價值，為$
在2024年第三季度，該公司承諾一項計劃，賣出其Xepi產品線，並確定此無形資產符合根據ASC 360-10-45-9的分類為「待售」的標準。該公司 已簽署意向書 並預計在接下來的六到十二個月內完成銷售，因此已將該資產分類為在合併資產負債表中的「待售」流動資產。該資產在分類時的帳面金額為$
8. 現金餘額及現金流量表調節
公司將其現金結餘存放在由聯邦存款保險公司（FDIC）保險的金融機構。截至2024年9月30日，公司的現金結餘中有約$
受限的現金主要包括根據我們企業信用卡條款持有的現金擔保存款。長期受限現金在合併資產負債表中記錄在其他資產中。
下表提供了現金、現金等價物和受限制現金的調節，使其總顯示在現金流量表中顯示的總額。
| （以千為單位） | 九月三十日， 2024 |
12月31日, 2023 |
||||||
| 現金 及現金等價物 | $ | $ | ||||||
| 長期 受限現金 | ||||||||
| 在綜合現金流量表中顯示的 總現金、現金等價物和受限現金 | $ | $ | ||||||
長期受限現金已記錄在資產負債表中的其他資產中。
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9. 應計費用及其他流動負債
應付費用及其他流動負債包括以下內容：
| （以千為單位) | 九月三十日， 2024 | 12月31日, 2023 | ||||||
| 員工補償和福利 | ||||||||
| 專業費用 | ||||||||
| 研發 | ||||||||
| 產品營業收入儲備 | ||||||||
| 分銷和儲存 | ||||||||
| 法律和解 | ||||||||
| 其他 | ||||||||
| 總計 | $ | $ | ||||||
10. 債務
信用額度
自2024年1月4日起，我們自願終止與Midcap業務信貸公司（以下稱“貸款協議”）的貸款及安防協議，
總共支付約$
由於終止貸款協議，公司在2024年9月30日結束的九個月的綜合損益表中，認列了一筆與預付費用和資金費用摊销有關的$的損失。
貸款 設施
於2023年12月21日，我們與兩位不同的貸款人簽訂了信貸協議（以下稱「貸款」），每筆貸款皆依據業務貸款及安防協議進行，提供本金金額為$
利息費用採用有效利率法確認，即在每期初將恆定有效利率應用於債務的攤銷金額，直至到期。
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11. 相關方交易
許可 和供應協議
根據Ameluz LSA，公司獲得了一項獨佔的、不可轉讓的許可，以使用Biofrontera Pharma的科技來市場推廣和賣出許可產品Ameluz。® 和RhodoLED® 燈具，且必須專門從Biofrontera Pharma購買授權產品。第二次A&R Ameluz LSA，除其他事項外，修訂了Ameluz LSA以：
(i) 根據預期淨售價的特定百分比，更新我們每單位支付的價格（“轉讓價格”）， 該價格涵蓋了商品成本、銷售版稅及服務費用，包括所有監管努力、代理費、藥物監察及 專利管理，具體如下：
| ● | ||
| ● | ||
| ● | ||
| ● | ||
| ● | 與目前正在研發的痤瘡等其他適應症相關的轉讓價格，將永久保持為 |
(ii) 提供與Ameluz相關的臨床試驗責任的轉移® 在美國於2024年6月1日或之前， 包括公司承擔相關合約並將關鍵人員從Ameluz授權方轉移至公司。
此外，關於第二A&R Ameluz LSA，公司於2024年2月13日與Ameluz授權方簽訂了索賠釋放協議，根據該協議，公司同意釋放Ameluz授權方對於第二A&R Ameluz LSA下公司承擔責任的臨床試驗中履行某些義務方面所引起的或有關的所有索賠和責任。
在截至2024年9月30日的三個月和九個月中，授權產品的購買額分別為$
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其他
公司每季從Biofrontera AG和Biofrontera Bioscience處收到費用報銷，用以抵銷代表該公司所支付的成本，這些成本會與銷售、一般及管理開支中的開支相抵。總費用報銷為 和 $
12. 股東權益
根據公司經修訂及更新的公司章程第二次修訂證書（“證書”）， 自2024年4月25日起生效，公司獲授權發行 普通股及 優先股，面值$ 。
2024年2月19日，公司根據《優先购股协议》進行了定向增發協議，公司同意發行並賣出某些股份，其中包括： Series b-1可轉換優先股，每股面值$ 股份（即“優先系列b-1優先股”），以及(ii) 購買2024年優先認股權來購買
在2024年2月22日，配合發行的結束，作為轉換的交易所， 系列b-1特別股的股份，公司發出了 普通股的股份。根據證書，在公司股東於2024年5月批准增發普通股授權股份（「股東批准」）後，剩餘的 系列b-1特別股的股份將自動轉換為系列b-2特別股（因為轉換為普通股會導致持有人超過各自的受益擁有權限制）， 可轉換的普通股股份將在系列b-2特別股轉換時發行。此外，在股東批准後，若發生任何清算事件，公司的可分配資產將根據每位持有人所持股份的數量，按比例分配給系列b特別股和普通股的持有者，為此目的，所有系列b特別股視為已轉換為普通股。隨著取消對系列b特別股的清算優先權，對中期融資分類的要求被取消，系列b特別股自2024年9月30日起被列為永久股權。注釋13. 可贖回特別股。)
在
2024年5月13日和14日，
根據首選購買協議，公司有權任命由Rosalind Advisors, Inc指定的兩名獨立董事加入公司董事會。
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修改公司章程 – B系列優先股
根據優先購買協議的條款，公司於2024年2月20日向特拉華州州務卿提交了指定證書，指定了 股份為b-1優先股， 股份為b-2優先股， 股份為b-3可轉換優先股，面值為每股 美元（統稱為「b系列優先股」）。
系列 b優先股權:
投票權 權利. 根據《指定證書》中描述的某些限制，系列b優先股為有表決權的股票。 系列b優先股的持有人有權與普通股一起按轉換為普通股的基準進行表決。 普通股的持有人在所有提交給股東表決的事項上有權每持有一股普通股進行一次表決。 因此，系列b優先股的持有人在所有提交給股東表決的事項上將有權按其系列b優先股可轉換的每一整股普通股進行一次表決。
轉換.
根據某些有利的持股限制，持有人可以選擇將每股b系列優先股轉換成普通股，按照適用的轉換價格四捨五入為最接近的整數股。b系列優先股的轉換價格為每股普通股$
清算. 根據股東批准，在公司任何自願或非自願清算、解散或終止的情況下， 包括控制權變更交易或根據《指定證書》定義的視為清算事件（任何此類事件， 稱為「清算），公司可供分配給其股東的資產應按比例在系列b優先股和普通股的持有者之間分配， 根據每位持有者持有的股份數量進行比例分配，為此目的，所有系列b優先股應視為 在該清算立即之前根據《指定證書》的條款轉換為普通股，而不考慮《指定證書》 中規定的任何轉換限制或其他限制。
參與 權利. 在發行結束後的一年內，購買者將有權作為投資者參與公司完成的任何證券發行。
普通 股票：
普通股股東每持有一股，享有一票投票權。除非董事會宣佈，否則普通股股東無權得到分紅派息。公司自成立以來尚未宣佈過分紅派息。在公司清算、解散或停業的情況下，普通股股東有權按比例分享支付債務後剩餘的所有資產。普通股無握股或轉換權利或其他認股權。普通股沒有適用於贖回或沉淪基金的條款。普通股的已發行股份已全額支付且無需追加款項。截至2024年9月30日，共有 股普通股債券已發行。
根據2023年預資助權證的行使和B-1優先股的轉換，發行普通股。
開啟 二零二四年一月八日及二零二四年二月二日，一名投資者行動 和 預先資助認股權證，以購買公司普通股權證 股票，面值 $ 每股（「預先資助認股權證」）分別購買總額 股份 以執行價格為 $ 的普通股 每股，導致收益淨額可忽略不大。
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13. 可贖回優先股
在股東批准之前，b-1系列優先股可以由持有者選擇贖回，而b-2和b-3系列優先股則在控制權變更的情況下可贖回。根據美國證券交易委員會的會計系列公告第268號（“ASR 268”）的ASC 480-10-S99-3A(2)，可贖回現金或其他資產的優先證券必須被歸類為永久股權之外的類別，若其可贖回條件為 (i) 在明確或可確定的價格於明確或可確定的日期贖回; (ii) 由持有者選擇贖回; 或 (iii) 在非唯一由發行者控制的事件發生時贖回。強制贖回的優先證券需由發行者列為負債，而根據ASR 268，若一項優先證券的贖回依賴於一個並非完全由發行者控制的事件，則應將其歸類為夾層股權。b-1系列優先股是由持有者選擇贖回的，b-3系列則在公司控制權變更的情況下可贖回，而這一變更並非完全在公司的控制之內。在股東批准之前，b系列優先股被視為在股息權和在公司自願或非自願清算、解散或結束事務時資產分配方面優於普通股和公司的所有其他系列。因此，公司認為在2024年2月發行時，將b系列優先股視為夾層股權是合適的，截至2024年3月31日，b系列優先股以該方式在我們的合併資產負債表和合併股東權益變動報表中呈現，並且在股東批准之前的期間該系列優先股被視為夾層股權。b系列優先股不被視為強制贖回。
經過股東批准後，每一股系列b-1優先股將自動轉換為普通股，或者在轉換會使持有者超出其實益擁有權限制的情況下，轉換為系列b-2優先股，從而取消持有者的贖回選項（該選項僅適用於系列b-1），並消除作為中間股權分類的一項要求。
根據股份持有人批准，在任何清算情況下，公司的資產將可供分配給其股東，將根據每位持有人的股份數量按比例在系列b優先股和普通股的持有者之間進行分配，為此目的，所有系列b優先股將被視為已根據2024年2月20日提交的指定證書的條款轉換為普通股。因此，系列b優先股在我們截至2024年9月30日的合併資產負債表和合併股東權益變動表中被列為永久性權益，這是由於ASC 480-10-S99-3A(3)(f)的有限例外。
2021 全面誘因計劃
在 2021年，我們的董事會通過了，並且我們的股東批准了2021年綜合激勵計劃（“2021計劃”），根據該計劃，最大 合約期限為 年，針對發出的股票期權。於2024年6月12日，公司股東批准了對 biofrontera inc. 2021年綜合激勵計劃的修訂，以增加授權發行的股份數量，增加了 股份，從 股，我們的流通普通股數量從 股份。截至2024年9月30日，根據修訂的2021 計劃，仍有 股份可供未來獎勵使用。
非合格 期權
我們 維持2021計畫，以造福我們的官員、董事及員工。根據2021計畫授予的員工股票期權通常 在三年的期間內以相等的年度分期方式歸屬，並且自授予日期起可行使的期限為最多十年。非員工 董事期權在授予日期後以相等的月度分期方式歸屬，並將在授予日期一周年時完全歸屬。所有期權的行使價格均由公司在授予時設定，但不得低於授予日期下的普通股市場價值。
公司按照甲示服務期間逐年直線基礎上所承認的以股份為基礎獎勵之授出當日公平價值，作為作為報酬費用。期權的公平價值是在授出當時使用BSm期權定價模型估計的，該模型需要使用輸入和假設，例如基礎股票的公平價值、期權的執行價格、預期期限、無風險利率、預期波動率和股息收益率。公司選擇根據其發生的方式來處理放棄賬戶。
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截至2024年9月30日的三個月內，公司發出了期權。 每個期權的公平價值是根據2024年7月12日的授予日期使用BSm期權定價模型估算的，其假設為：基礎單位的公平價值為$ %的無風險利率，預期期間為 %，期限從 年到 年，並且股息率為零。
三個以及截至2024年9月30日結束的九個月，股票期權的基於股份的薪酬費用約為$ 百萬和$ 百萬美元，分別記錄在銷售、總務和管理費用中，在財務報表的附屬綜合營運報表中，記錄了微不足道的金額作為研究 以及發展。為了三個以及截至2023年9月30日結束的九個月，基於股份的薪酬費用為$ 百萬美元和$ 百萬美元，分別記錄在銷售、總務和管理費用中。
| 股份 | 加權 平均值 行使 價格 | 加權 平均值 剩餘 合約上的 條款 | 總計 內在價值 價值（1） | |||||||||||||
| 2023年12月31日未償還債務優良。 | $ | |||||||||||||||
| 已授予 | $ | |||||||||||||||
| 已行使 | $ | |||||||||||||||
| 取消或喪失 | ( | ) | $ | |||||||||||||
| 至2024年9月30日止的未解決事項 | $ | $ | ||||||||||||||
| 可在2024年9月30日行使 | $ | $ | ||||||||||||||
| (1) |
截至2024年9月30日，未發行的股份相關的總未認列補償成本為$ 未認列之與未授予期權相關的百萬美元補償成本，預計將在約加權平均期間內確認。 年。
基於股份的補償（限制股票單位）
受限 股票單位（“RSUs”）將在兩年內每年歸屬，前提是受贈者在適用的歸屬日期繼續為公司服務。 每個RSU的公允價值是根據授予日期公司的普通股收盤市場價格來確定的。
以股份為基礎的 補償費用為RSUs為$ 百萬美元，截止至2024年9月30日的三個月和九個月，和$ 百萬和$ 百萬美元，截止至2023年9月30日的三個月和九個月，並記錄於隨附的合併損益表中的銷售、一般及行政 費用。
| 股份 | 加權 平均值 剩餘 合約上的 條款 |
加權平均 授予日期 公允價值 | ||||||||||
| 2023年12月31日未償還債務優良。 | $ | |||||||||||
| 授予 | - | $ | ||||||||||
| 已歸屬 | ( | ) | - | $ | ||||||||
| 已取消或沒收 | - | $ | ||||||||||
| 至2024年9月30日止的未解決事項 | $ | |||||||||||
截至2024年9月30日，未發行的股份相關的總未認列補償成本為$ 百萬未確認的與限制性股票單位相關的補償成本，預計將在 約為加權平均期間內確認 年。
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15. 利息費用，淨額
利息 支出，淨額包括以下內容：
結束的三個月 九月三十日， | 九個月結束 九月三十日， | |||||||||||||||
| （以千為單位) | 2024 | 2023 | 2024 | 2023 | ||||||||||||
| 利息支出 | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| 關聯方利息支出 | ( | ) | ( | ) | ||||||||||||
| 合約資產利息費用 | ( | ) | ( | ) | ||||||||||||
| 利息收入 | ||||||||||||||||
| 利息收入（費用），淨額 | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||||
利息支出主要由我們的短期貸款和信用額度的利息組成，包括遞延成本的攤銷。
合同資產利息費用涉及一個百萬美元的合同資產。 百萬美元新創成本融資來自Maruho Co.， Ltd.（“ Maruho”）根據一份股份購買協議。 合同資產根據一份百分之〇〇利率使用直線法分期攤銷，此融資安排合同的結束日期為 。 .
利息收入主要與存入我們銀行帳戶的所有基金類型所賺取的利息有關。
公司使用雙類股法計算每股淨利（淨損）。截至2024年和2023年9月30日止三個和九個月未宣布或支付任何分紅派息。每個期間的未分配盈餘根據安全與普通股東按照安全參與權利平均分配，共同分享目前收益，就好像所有目前期間收益均已派發。按照雙類股法，未分配虧損將完全分配給普通股股東。基本每普通股盈餘（淨損）是通過將淨利潤除以期間內流通普通股的加權平均數計算得到的。每普通股稀釋盈餘是通過將淨利潤（淨損）除以期間內流通普通股的稀釋加權平均數計算得到的。稀釋股份包括基於庫藏股法的股份獎勵的稀釋效果。
在記錄淨虧損的期間，不會考慮潛在摻稀證券的影響，因為其效果會是反摻稀的。
| 結束的三個月 | 九個月結束 | |||||||||||||||
| 九月三十日， | 九月三十日， | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| 淨損失 | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| 基本和稀釋後每股平均股份 | ||||||||||||||||
| 每股淨損，基本與稀釋 | $ | ) | $ | ) | $ | ) | $ | ) | ||||||||
| 20 |
| 九月三十日， | 2024 | 2023 | ||||||
| 普通股權證 | ||||||||
| 普通股期權和限制性股票單位 | ||||||||
| 單位購買期權 | ||||||||
| 與B系列b-2可轉換優先股相關的股份 | ||||||||
| 與B系列b-3可轉換優先股相關的股份 | ||||||||
| 總計 | ||||||||
普通股認股權證包括購買權證、誘因權證以及在公司首次公開募股中發行的認股權證。
17. 承諾和條件
租賃
公司租賃其公司總部，根據一份將於2025年8月到期的營運租約。公司有權利
該公司還與其車輛簽訂了主要租賃協議。在最初的不可取消的十二個月期滿後，每輛車均以月租的方式租賃。根據約三年的歷史保留經驗，這些車輛的到期日期各不相同，直至2027年10月。
截至2024年9月30日的九個月內，該公司錄得租賃費用為$
| 截至12月31日的年度 | 未來租約 承諾 | |||
| 2024年剩餘部分 | $ | |||
| 2025 | ||||
| 2026 | ||||
| 2027 | ||||
| 其後 | ||||
| 未來最低租金支付總額 | $ | |||
| 扣除假定利息 | ( | ) | ||
| 租賃負債總額 | $ | |||
| 報告如下： | ||||
| 營運租賃負債，流動 | $ | |||
| 非流動營業租賃負債 | ||||
| 總計 | $ | |||
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Ameluz LSA 銷售承諾
該
條款應自動延續五年，無限期有效，只要我們從Ameluz產品及
燈具中獲得的收入等於或大於$
此外，從2025年開始，在第二次A&R Ameluz LSA下，我們同意購買Ameluz最少管數的較高者® 每年或至少最低75%的經審核Ameluz的年度平均銷售數量® 在前四（4）個完整的日歷年度中售出的管數（「年度最低銷售」）。如果我們未能實現任何日歷年度的年度最低銷售，則此失敗將構成終止事件，除非Ameluz授權方放棄。
Ameluz® 最低研發成本（“最低研發成本”）
在2025年至2030年間，我們將被要求提供最低的研發成本，金額至少為 (i) 產品的轉讓價格，自2024年2月13日起生效，與 (ii) 根據2021年10月8日的前Ameluz LSA所確定的產品轉讓價格之間的差額的85%。如果我們未能滿足最低要求，差額將在2031年2月15日支付給Biofrontera Pharma，支付方式可選擇現金或我們的普通股，具體由我們自行決定。
授權 與光學工具的協議
2022年12月2日，公司與Optical Tools LLC（“Optical Tools”），Stephen Tobin和Paul Sowyrda（“協議”）簽訂了技術轉讓協議。 協議允許轉讓指定專利和商標，並在公司通知Optical Tools後，進行某些原型的研發。 公司支付了一筆許可費為$
在2023年5月28日，公司授權光學工具設計、開發、製造和交付至少兩個便攜式光動力治療燈原型（“PDt設備”），使用指定專利中的科技。PDt設備根據不同的光譜為人體外皮膚提供照明。根據協議，公司需就光學工具因所有合理的雜費、材料和勞動成本進行補償。
根據協議，光學工具有資格獲得總額高達美元的監管和銷售里程碑支付。
公司在截止至2024年及2023年9月30日的三個月及九個月內，並未就此類付款進行任何里程碑或特許權使用費的付款或應計。
Ferrer Internacional S.A.與里程碑支付。
根據Xepi LSA，當特定里程碑發生時，我們有責任向Ferrer支付款項。具體而言，我們必須支付Ferrer
(i) $
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法律 程序
在每個報告日期，公司評估潛在損失金額或潛在損失區間在FASb ASC主題450規定下是否可能及可合理估算。 應變。公司將與此類法律程序相關的法律費用在發生時記入費用。
法律 索賠
開啟 2023 年 9 月 13 日，Biofrontera 獲得由杜莎製藥股份有限公司、太陽製藥工業股份有限公司提出的投訴。 （「Sun」），以及 DUSA 指控 i) 違反合同、ii) 違反蘭咸條款的新藥工業有限公司 法律，以及 iii）馬薩諸塞州法律下的不良貿易做法。所有聲稱都源於稱生物弗龍特拉已推廣其阿梅魯茲的指控® 以與 FDA 批准的標籤不符的方式產品。儘管這個投訴最初是在美國提交的。 馬薩諸塞州地區法院，該事件已經雙方同意轉移到美國地區 新澤西州地區法院。2024 年 3 月，生物弗龍特拉公司提出部分動議解僱 蘭漢姆法案和馬薩諸塞州法定索賠，該法案在 2024 年 10 月 15 日被拒絕。生物流星隨後回答了太陽的答案 投訴並提出反訴，指稱 i）違反蘭漢法，ii）佐治亞州法律下的欺騙性貿易做法，以及 iii) 貿易 /產品。
另外，在2024年6月26日和2024年6月27日，Sun向美國麻薩諸塞特區地方法院和國際貿易委員會分別提起兩項訴訟，控告Biofrontera、Biofrontera AG、Biofrontera Pharma和Biofrontera Bioscience侵犯Sun持有的兩項專利。 在美國麻薩諸塞特區地方法院訴訟案件完成前，該案已被暫緩。
發現 在上述提及的事項中仍在進行中。公司否認孫氏提出的索賠並打算積極捍衛。根據公司對上述索賠事實的評估，訴訟的不確定性以及案件的初步階段，公司無法估計可能出現的實質損失可能性，以及損失的潛在區間。如果該事項的最終解決對公司不利，則可能對公司的財務狀況、營運或現金流量產生實質影響。
18. 隨後的事件
我們已完成2024年9月30日資產負債表日期後至提交至SEC的此季度10-Q表格日期間對後續事項的評估，並確定以下重要後續事項需要揭露。
在2024年10月， FDA批准了該公司的補充新藥申請，以增加Ameluz的最大批准劑量® 從每次治療一管增加到三管。這項批准允許使用Ameluz®-PDT進行面部和頭皮的Ak大面積治療 使用BF-RhodoLED® 或RhodoLED® XL燈。
During November 2024, shares of Series B Convertible Preferred were converted into shares of common stock.
於 2024年11月11日，公司與首席執行官及董事會主席亨曼·盧伯特簽訂了一份修訂及重述的雇佣合約。修訂及重述的合約(a)要求盧伯特先生在收到任何遣散費之前，需提供一份公司合理接受的放棄和解除索賠的文件；(b)提升盧伯特先生的遣散費金額，若他的雇佣在「控制權變更」(如文中所定義)的前3個月內或12個月後終止。
上述對經修訂及重述的僱傭合約的描述並不聲稱為完整，並且其全部內容均以本報告中所附的修訂及重述的僱傭合約副本（作為附件10.1）為準，並納入本文中作為參考。
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項目 2. 管理層對財務狀況和營運結果的討論與分析
管理層討論和分析（"MD&A"）提供了補充信息，概述了影響我們財務狀況和營運成果的主要因素，應該與基本報表和相關附註一起閱讀。以下信息應該有助於更好地理解影響我們收益表現和財務狀況的主要因素和趨勢，以及我們在2024年第一季度的表現如何與去年同期相比。在整個本節中，Biofrontera Inc.，包括其全資子公司Biofrontera Discovery GmbH（“Discovery”或“子公司”），被稱為“公司”，“我們”，“我們”或“我們的”。
前瞻性陳述
1995年的《私人證券訴訟改革法》為前瞻性陳述提供了一個「安全港」。這份10-Q表格中的某些陳述構成了「前瞻性陳述」。這些陳述包括我們費用的估計、未來營業收入、資本需求、我們對額外融資的需求、關於我們正在開發的技術的效力和預期用途的陳述，將被授權產品推向市場的時間表和策略，我們授權產品的監管審查和批准時間表，以及其他不是歷史事實的陳述。 「意圖」、「可能」、「將」、「計劃」、「預期」、「期望」、「項目」、「預測」、「估計」、「目標」、「相信」、「希望」、「潛力」、「目標」、「目標」、「假設」、「將會」、「可能」或類似詞語的用詞，旨在列明前瞻性陳述，雖然不是所有的前瞻性陳述都包含這些識別詞語。 您應該閱讀這份10-Q表格以及我們作為展示文件提交的所有文件，並了解我們的實際未來結果可能與我們預期的大不相同。 雖然我們這些前瞻性陳述基於我們對未來事件的當前期望和預測，但我們實際上可能無法實現我們在前瞻性陳述中披露或暗示的計劃、意圖或期望，您不應過分依賴我們的前瞻性陳述。 這些前瞻性陳述受到我們及相關方面的風險、不確定性和假設的影響，因此，實際結果或事件可能與我們在前瞻性陳述中披露或暗示的計劃、意圖和期望大不相同。
因素 可能導致此類差異的原因包括但不限於：
| ● | 我們主要授權產品Ameluz的成功®; | |
| ● | 我們依賴從其他公司授權產品銷售作為我們唯一的營業收入來源； | |
| ● | 的能力 Biofrontera Pharma GmbH（“Biofrontera Pharma”），Biofrontera Bioscience GmbH（“Biofrontera Bioscience”）和Ferrer Internacional S.A.（“Ferrer”），統稱為我們的（“許可方”）以建立和維持與 代工廠商的關係，這些代工廠商能夠向我們供應足夠的授權產品以滿足我們的需求； | |
| ● | 我們的許可方或我們的許可方的 製造合作夥伴，必要時能提供Ameluz®，RhodoLED® 燈具，Xepi® or other licensed products that we market in sufficient quantities and at acceptable quality and cost levels, and to fully comply with current good manufacturing practice or other applicable manufacturing regulations; | |
| ● | the ability of our Licensors to successfully defend or enforce patents related to our licensed products; | |
| ● | the impact of legislative and regulatory changes; | |
| ● | our ability to obtain additional financing as needed to implement our growth strategy; | |
| ● | 我們在實現盈利方面的成功； | |
| ● | 我們保留和招募關鍵人才的能力； | |
| ● | 我們有效管理和控制與臨床試驗操作相關的成本； | |
| ● | 我們競爭對手成功開發能成功與我們授權產品競爭的通用局部治療皮膚產品的成功； | |
| ● | 保險覆蓋和醫療費用報銷對我們的授權產品的可用性； |
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| ● | 來自其他藥品和器械公司的競爭，以及現有的治療方法，例如簡單的刮治術和冷凍療法；以及 | |
| ● | 此 其他風險在 第1A項。風險因素 我們2023財政年度截至12月31日的10-k表格年度報告中 （於2024年3月15日提交給證券交易委員會（“SEC”）的“10-K表格”），第二部分第1A項 此季度報告的10-Q表格及任何其他提交給SEC的文件中。 |
有關我們更詳盡的信息以及可能影響前瞻性陳述實現的風險因素，包括本季度報告表格10-Q中的前瞻性陳述，均載於我們向證券交易委員會提交的文件中，包括我們的10-K表格。我們敦促投資者和證券持有人在SEC的網站www.sec.gov免費閱讀這些文件。我們不承諾根據新信息、未來事件或其他原因公開更新或修訂我們的前瞻性陳述，除非法律要求。
Overview
We are a U.S.-based biopharmaceutical company commercializing a portfolio of pharmaceutical products for the treatment of dermatological conditions with a focus on photodynamic therapy (“PDT”) and topical antibiotics. The Company’s licensed products are used for the treatment of actinic keratoses (“AKs”), which are pre-cancerous skin lesions, as well as impetigo, a bacterial skin infection. Our subsidiary, Discovery, was formed on February 9, 2022, as a German presence that manages our clinical trial work and facilitates our relationship with Biofrontera Pharma and Biofrontera Bioscience (together, the “Ameluz Licensor”), both of which are related parties as they are wholly owned subsidiaries of Biofrontera AG.
Our principal licensed product is Ameluz®, which is a prescription drug approved for use in combination with PDT (when used together, “Ameluz® PDT”) using the BF-RhodoLED® and the RhodoLED® XL lamps (the “RhodoLED® Lamps”). In the United States, the PDT treatment is used for the lesion-directed and field-directed treatment of AKs of mild-to-moderate severity on the face and scalp. AKs are premalignant lesions of the skin that can potentially develop into skin cancer (squamous cell carcinoma) if left untreated. International treatment guidelines list PDT as the “gold standard” for treating AK, especially multiple AKs and the surrounding photodamaged skin.1 We are currently selling Ameluz® for this indication in the U.S. under an exclusive license and supply agreement, the Second Amended and Restated License and Supply Agreement, effective as of February 13, 2024 with the Ameluz Licensor (the “Second A&R Ameluz LSA”).
Effective June 1, 2024, we assumed control of all clinical trials relating to Ameluz® in the United States, allowing for more effective cost management and direct oversight of trial efficiency. Our research and development (“R&D”) program is focused on label expansion for Ameluz® as well as supporting PDT growth by improving the capabilities of our RhodoLED® Lamps to better fulfill the needs of dermatologists. Our goal is to improve the effectiveness of our commercial team by allowing sales representatives to carry approved devices with them allowing for easier product demonstrations and evaluations.
In October 2024, the FDA approved the Company’s Supplemental New Drug Application to increase the maximally approved dosage of Ameluz® from one to three tubes per treatment. This approval allows healthcare professionals greater flexibility in addressing larger or multiple treatment areas for patients undergoing PDT for AK on the face and scalp, leading to greater convenience for both healthcare providers and their patients. In combination with the RhodoLED® XL Lamp, providers can now treat a patient’s face more efficiently. Additionally, the change to the label and the RhodoLED® XL are both foundational to support trunk and extremities which we expect to add to the label in the next couple years.
Also, in October 2024, the Company received results in its Phase III trial evaluating its drug-device therapy, Ameluz® with the BF-RhodoLED lamp, as a treatment for superficial basal cell carcinoma (“sBCC”). The primary endpoint was a composite of complete clinical and histological clearance of one preselected “main target” BCC lesion per patient 12 weeks after the start of the last PDT cycle. According to the phase III ALA-BCC-CT013 study, Ameluz®-PDT achieved 65.5% success, compared to 4.8% success achieved with placebo-PDT. Complete histological clearance was seen in 75.9% of these lesions in the Ameluz® arm, compared to 19.0% with placebo. Complete clinical clearance was achieved in 83.4% of patients treated with Ameluz® compared to 21.4% with placebo.
Effective with the Second A&R Ameluz LSA, the price we pay per unit, based on certain percentages of the anticipated net selling price, (the “Transfer Price”) of Ameluz® was reduced from 50% to 25% for all purchases through 2025. Starting on January 1, 2026, until 2032 there will be stepwise increases in the Transfer Price from 25% to 35% for sales related to AK and, if approved by the Food and Drug Administration (the “FDA”), basal cell carcinoma and squamous cell carcinoma. The Transfer Price for sales related to acne, another indication currently in development, will remain at 25% indefinitely. The Transfer Price covers the cost of goods, royalties on sales, and services including all regulatory efforts, agency fees, pharmacovigilance, and patent administration. The reduced LSA Transfer Price will allow the Company to finance the R&D activities assumed as of June 1, 2024, and continue our commercial growth trajectory.
Our second prescription drug licensed product in our portfolio is Xepi® (ozenoxacin cream, 1%), a topical non-fluorinated quinolone that inhibits bacterial growth. Currently, no antibiotic resistance against Xepi® is known and it has been specifically approved by the FDA for the treatment of impetigo, a common skin infection, due to Staphylococcus aureus or Streptococcus pyogenes. It is approved for use in the United States in adults and children 2 months and older. Our exclusive license and supply agreement, as amended (“Xepi LSA”), with Ferrer that we assumed on March 25, 2019 through our acquisition of Cutanea Life Sciences, Inc. (“Cutanea”) enables us to market and sell this product in the United States. The Company has generated limited revenue from sales of Xepi due to third-party manufacturing delays that have hampered our commercialization of the product. Ferrer is now in the process of qualifying a new contract manufacturer. If the new contract manufacturer is qualified, we believe that it will be able to supply enough of the Xepi® product line to meet market demand for as long as we maintain it.
However, in the third quarter of 2024, the Company reached the decision to divest its Xepi product line and determined that it met the held for sale accounting criteria. The Company has entered into a letter of intent and expects to complete the sale within the next six to twelve months. The related intangible asset is presented as held for sale under current assets in the Condensed Consolidated Balance Sheets. See Note 7. Assets Held for Sale, for additional information.
1Werner RN, Stockfleth E, Connolly SM, et al. Evidence- and consensus-based (S3) Guidelines for the Treatment of Actinic Keratosis - International League of Dermatological Societies in cooperation with the European Dermatology Forum - Short version. J Eur Acad Dermatol Venereol. 2015;29(11):2069-2079. doi:10.1111/jdv.13180.
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Our principal objective is to increase the sales of our licensed products in the United States. The key elements of our strategy include the following:
| ● | 擴大我們對Ameluz在美國的銷售® 與RhodoLED結合使用® 用於治療面部和頭皮輕度至中度厚度的AKs的燈具，並將Ameluz定位為標準護理® 在美國擴大我們的專用銷售和行銷製造行業，並將Ameluz定位為美國的護理標準； |
| ● | 透過我們與許可方的授權和供應協議，在美國市場努力推進我們產品組合中處於流程中的產品未來批准和標籤擴展的潛力；以及 |
| ● | 透過收購或授權知識產權來機會主義地將補充性產品或服務納入我們的產品組合，進一步發揮我們的商業基礎建設和客戶關係。 |
我們 t全力投入可觀的現金資源於我們授權產品的商業化，Ameluz® 以及 RhodoLED® 燈具。我們通過產品 銷售產生的現金收益、信用額度、短期債務及股權融資所獲得的收益來為我們的營運和資本支出提供資金。
我們 相信我們的營運結果的重要指標包括產品營業收入、營運利潤（虧損）和調整後的EBITDA（如下定義的非美國公認會計原則指標）。我們產品營業收入的唯一來源是銷售我們從某些相關和不相關公司授權的產品。我們的長期財務目標包括持續的收入增長和擴大營運利潤率。因此，我們專注於授權產品銷售的擴張，以推動營業收入的增長並提高營運效率，包括有效的資源利用、資訊科技利用和間接成本管理。
影響我們表現的主要因素
由於許多因素的影響，我們的歷史營運結果可能無法與未來時期的營運結果相比，而我們的營運結果也可能無法直接比較不同時期的營運結果。以下簡要討論了影響我們營運結果的關鍵因素。
季節性
由於傳統光動力療法治療採用燈泡，因此在冬季進行得更加頻繁，我們的營業收入會受一定的季節性影響，歷史上第一季度和第四季度的收入通常比第二季度和第三季度高。
供應鏈
我們的授權方在確保業務授權產品成功生產方面採取合理預防措施，但他們的合同製造商可能遇到各種業務困難（例如，勞動力不穩定、供應鏈問題、客戶基礎侵蝕等），可能影響他們的財務穩定性。我們在交付RhodoLED時歷史上曾經歷過延遲交貨時間的情況。® 因供應鏈問題，我們的燈具可能會面臨額外的供應鏈挑戰，或者我們的訂單完成速度低於預期。儘管過去和可能的未來延遲，我們預計總收入不會受到顯著影響（例如，相較於銷售衰退，我們的增長不如預期），因為我們的大部分收入來自Ameluz的銷售，我們手上和訂單中還有RhodoLED燈具。® 和我們手頭上和訂單中的RhodoLED燈具。® 我們持續監控供應鏈對我們業務的影響，並致力確保Ameluz供應鏈的穩定性。® 和RhodoLED® 燈具。
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營運成果的組成部分
產品 營業收入，淨額
我們通過授權產品Ameluz的第三方銷售來產生產品營業收入®RhodoLED燈的第三方銷售，以及在很小程度上的Xepi® Lamps燈具，並且在很小幅度上是Xepi® 由我們與許可方簽訂的獨家許可和供應協議規定. 產品銷售的營業收入記錄除了折扣、回扣和其他獎勵，包括貿易折扣和津貼、產品退貨、政府回贈，以及靠患者共同支付協助等其他獎勵之後的淨額® 燈具 及Xepi® 相較於我們Ameluz銷售所產生的營業收入，其他收入相對較低。®.
判斷我們營業收入的主要因素來自我們授權產品:
| ● | 我們銷售團隊產生的訂單水平； |
| ● | 我們授權產品的處方水平和機構需求；以及 |
| ● | 單位銷售價格。 |
Related Party Revenues
Prior to June 1, 2024, the date on which we took over clinical trials, we generated insignificant related party revenue in connection with an agreement with Biofrontera Bioscience to provide BF-RhodoLED® lamps and associated services for the clinical trials performed by Biofrontera Bioscience. In the future, we do not expect to receive related party revenue regarding lamps and associated services for clinical trials.
Cost of Revenues, Related Party
Cost of revenues, related party, is comprised of purchase costs of our licensed products, Ameluz® and RhodoLED® Lamps from Biofrontera Pharma and insignificant inventory adjustments due to scrapped, expiring and excess products.
我們在2024年2月12日前購買的庫存所支付的轉讓價格，是根據2021年10月8日修訂的Ameluz LSA而定的， 該價格是基於我們的銷售歷史而定的。我們支付給Ameluz授權方的Ameluz購買價格® 是根據以下方式確定的：
| ● | 五十 百分之五十的預期淨售價每單位，直到我們從授權的Ameluz產品銷售中產生3000萬美金的營業收入 在某一商業年度內（依據Ameluz LSA的定義）； |
| ● | 四十 百分之四十的預期淨售價每單位，對於我們在3000萬美金到5000萬美金之間產生的所有營業收入 的授權Ameluz產品銷售；及 |
| ● | 三十 百分之三十的預期淨售價每單位，對於我們在5000萬美金以上產生的所有營業收入 的授權Ameluz產品銷售。 |
Effective February 12, 2024, the Second A&R Ameluz LSA, among other things, was amended to change the Transfer Price to 25% of the anticipated net selling price per unit through 2025 and then increasing over time pursuant to the schedule set forth in the Second A&R Ameluz LSA to a maximum of 35% of the anticipated net selling price starting in 2032, subject to a minimum dollar amount per unit. We expect to see an impact from the change in the transfer pricing under the Second A&R Ameluz LSA in the fourth quarter as we receive product under the new pricing.
Cost of Revenues, Other
Cost of revenues, other, is comprised of purchase costs of our licensed product, Xepi®, third-party logistics and distribution costs including packaging, freight, transportation, shipping and handling costs, and inventory adjustment due to expiring Xepi® products.
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Selling, General and Administrative Expense
Selling, general and administrative expenses consist principally of costs associated with our sales force, commercial support personnel, personnel in executive and other administrative functions, and medical affairs professionals. Other selling, general and administrative expenses include marketing, trade, and other commercial costs necessary to support the commercial operation of our licensed products and professional fees for legal, consulting and accounting services. Selling, general and administrative expenses also include the amortization of our intangible assets and our legal settlement expenses.
Selling, General and Administrative Expenses, Related Party
Selling, general and administrative expenses, related party, relate to the services provided by our significant stockholder, Biofrontera AG, primarily for regulatory support and pharmacovigilance. These expenses are charged to us based on costs incurred plus 6% in accordance with the Amended and Restated Master Contact Services Agreement entered into on December 2021 (the “2021 Services Agreement”). The 2021 Services Agreement enables us to continue relying on Biofrontera AG and its subsidiaries for various services it has historically provided to us, including regulatory and pharmacovigilance support for as long as we deem necessary. We currently have statements of work in place regarding regulatory affairs, medical affairs, pharmacovigilance, and investor relations services, and are continuously assessing the other services historically provided to us by Biofrontera AG to determine (i) if they will be needed, and (ii) whether they can or should be obtained from other third-party providers.
Research and Development
Effective June 1, 2024, we took control of all clinical trials for Ameluz® in the Unites States, allowing for more effective cost management and direct oversight of trial efficiency. Our R&D expenses include costs directly attributable to the clinical development of Ameluz®, including personnel-related expenses, the cost of services provided by outside contractors, including services related to the Company’s clinical trials, facilities, depreciation, and other direct and allocated expenses. Along with our Ameluz® clinical trials, our R&D program also aims to improve the capabilities of our RhodoLED® Lamps to better fulfill the needs of dermatologists and improve the effectiveness of our commercial team by letting sales representatives carry approved devices with them, allowing for easier product demonstrations and evaluations. All costs associated with research and development are expensed as incurred.
Change in Fair Value of Warrant Liabilities
For warrants that are classified as liabilities, the Company records the fair value of the warrants at each balance sheet date and records changes in the estimated fair value as a non-cash gain or loss in the consolidated statements of operations until the warrants are exercised, expire or other facts and circumstances lead the warrant liabilities to be reclassified to stockholders’ equity or deficit.
Change in Fair Value of Investment, Related Party
Our investments are comprised of equity securities in shares of Biofrontera AG, which are initially recorded at cost, plus transaction costs, and subsequently measured at fair value, based on quoted market prices, with the gains and losses reported in the Company’s consolidated statement of operations. For the investments held in foreign currencies, the change in fair value attributable to changes in foreign exchange rates is included in gains and losses in the consolidated statement of operations.
Loss on Debt Extinguishment
On May 8, 2023, the Company entered into a Loan and Security Agreement (the “Loan Agreement”) with MidCap Business Credit LLC, providing us with a revolving line of credit in the aggregate principal amount of up to $6.5 million. Effective as of January 4, 2024, we voluntarily terminated the Loan Agreement and recognized a $0.3 million loss on debt extinguishment upon the early termination related to prepayment fees and the write-off of deferred financing costs.
Interest Income (Expense), net
利息支出，淨額，主要包括我們債務工具的利息，以金額微不足道的由金融機構融資顧客購買BF-RhodoLED的現金餘額所產生的利息收入抵銷。® 燈。
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其他 收入（支出），淨額
其他 收入（費用），淨額主要包括 (i) 回收租賃資產的利得（損失）及 (ii) 外幣交易的利得（損失）。
收入 稅收
由於自成立以來每個財政年度均有淨虧損，我們在此期間沒有計提聯邦所得稅。 所得稅費用僅與州所得稅有關。
營運結果
2024年9月30日及2023年同期三個月比較
以下表格總結了截至2024年和2023年9月30日的三個月經營結果：
| (以千為單位） | 2024 | 2023 | 變化 | |||||||||
| 產品收入，淨額 | $ | 9,012 | $ | 8,879 | $ | 133 | ||||||
| 相關方收入 | - | 17 | (17 | ) | ||||||||
| 淨收入 | $ | 9,012 | $ | 8,896 | $ | 116 | ||||||
| 營業費用： | ||||||||||||
| 成本收入，相關方 | 4,801 | 4,495 | 306 | |||||||||
| 成本收入，其他 | 76 | 95 | (19 | ) | ||||||||
| 銷售、總體和行政 | 8,425 | 8,619 | (194 | ) | ||||||||
| 售買、管理及行政費用，關聯方 | 1 | 74 | (73 | ) | ||||||||
| 研究 與發展 | 669 | 33 | 636 | |||||||||
| 按公允價值評估變動的待定款項 | - | 200 | (200 | ) | ||||||||
| 營業費用總額 | 13,972 | 13,516 | 456 | |||||||||
| 營運損失 | (4,960 | ) | (4,620 | ) | (340 | ) | ||||||
| 按公允價值評估變動的認股權債務 | (680 | ) | 598 | (1,278 | ) | |||||||
| 按公允價值評估變動的投資，關聯方 | (2 | ) | (2,212 | ) | 2,210 | |||||||
| 利息 收入（支出）淨額 | 8 | (142 | ) | 150 | ||||||||
| 其他損益淨額 | (32 | ) | 35 | (67 | ) | |||||||
| 所得稅前損失 | (5,666 | ) | (6,341 | ) | 675 | |||||||
| 所得稅費用 | 3 | 1 | 2 | |||||||||
| 淨 損失 | $ | (5,669 | ) | $ | (6,342 | ) | $ | 673 | ||||
Product Revenue, net
Net product revenue for the three months ended September 30, 2024 increased by $0.1 million, or 1.5% as compared to the three months ended September 30, 2023. This increase was driven by $0.6 million increase from sales of devices, specifically RhodoLED® XL Lamp, since its launch in June 2024, offset by net decrease in sales of Ameluz of $0.5 million. The decrease of Ameluz sales in units in the three months ended September 30, 2024 was impacted by the delayed shipment of about 4,600 units at the end of September 2024 due to Hurricane Milton, which forced office closures and shipping delays through the Southeast. All shipments were delivered, and revenue for these sales have been recognized in October 2024.
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Operating Expenses
Cost of Revenues, Related Party
Cost of revenues, related party for the three months ended September 30, 2024 increased by $0.3 million, or 6.8% as compared to the three months ended September 30, 2023. This was driven by an increase of $0.5 million due to the increase in RhodoLED® XL product revenue, partially offset by a decrease of $0.2 million, due to decrease in sales of Ameluz®. We expect to see an impact from the change in the transfer pricing under the Second A&R Ameluz LSA in the fourth quarter as we are receiving product under the new pricing.
Selling, General and Administrative Expenses
Selling, general and administrative expenses for the three months ended September 30, 2024 decreased by $0.2 million, or 2.3% as compared to the three months ended September 30, 2023. The decrease was primarily driven by a $0.5 million decrease in general business administration expenses, as well as a decrease of non-personnel sales and marketing expenses of $0.2 million, and a $0.3 million decrease in personnel costs due to change in headcount and reduced severance, which was offset by a $0.8 million increase in legal expenses related to the complaints filed by DUSA Pharmaceuticals, Inc., Sun Pharmaceutical Industries, Inc., and Sun Pharmaceutical Industries LTD (collectively “SUN”) with the International Trade Commission (“ITC”) and the US District Court for the district of Massachusetts.
Research and Development Expenses
R&D expenses for the three months ended September 30, 2024 increased by $0.6 million as compared to the three months ended September 30, 2023. The increase was attributable to our assumption of all clinical trial activities for Ameluz® in the United States effective June 1, 2024, allowing for more effective cost management and direct oversight of trial efficiency. This increase to R&D expenses should be offset by a reduction in the Transfer Price of Ameluz® from 50% to 25% for all future purchases made in 2024 and 2025. No such inventory purchases were made as of September 30, 2024. The following table summarizes our research and development expenses:
| 截至九月三十日止的三個月, | ||||||||
| 2024 | 2023 | |||||||
| 光老年性 角化症 | $ | 206 | $ | - | ||||
| 中度 至重度痤瘡 | 129 | - | ||||||
| 表浅 基底電芯癌 | 44 | - | ||||||
| 便攜式設備 | 33 | - | ||||||
| 人員成本相關 費用 | 203 | - | ||||||
| 其他 研究和發展 | 54 | 33 | ||||||
| $ | 669 | $ | 33 | |||||
權證負債公允價值變動
認股權負債公允價值變動於2024年9月30日結束的三個月為($0.7)百萬美元，與2023年9月30日結束的三個月相比為60萬美元。認股權負債的公允價值變動主要受到普通股市場報價的變化影響。從2024年6月30日至2024年9月30日，公司普通股的基礎價值增加，導致認股權負債價值相應增加並在營運報表中確認額外費用。從2023年6月30日至2023年9月30日，市場價格下降，導致認股權負債價值下降，營運報表中出現盈餘。
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投資公允價值變動，關聯方
截至2023年12月31日，公司已將其在Biofrontera AG的所有投資幾乎全部轉讓給Maruho，以換取根據2023年12月27日簽署的和解協議及相互解除（以下簡稱「解除」）而釋放的某些義務。因此，在2024年第三季度，我們在Biofrontera AG的投資淨餘額微乎其微，相關公平價值的變化也是如此。
比較 截至2024年9月30日和2023年的九個月
下表總結了截至2024年9月30日及2023年9月30日的九個月營運結果：
| (以千為單位） | 2024 | 2023 | 變化 | |||||||||
| 產品收入，淨額 | $ | 24,744 | $ | 23,423 | $ | 1,321 | ||||||
| 相關方收入 | 18 | 52 | (34 | ) | ||||||||
| 淨收入 | $ | 24,762 | $ | 23,475 | $ | 1,287 | ||||||
| 營業費用： | ||||||||||||
| 收入成本，相關方 | 12,839 | 11,814 | 1,025 | |||||||||
| 收入成本，其他 | 496 | 262 | 234 | |||||||||
| 銷售、總體和行政 | 25,589 | 29,874 | (4,285 | ) | ||||||||
| 出售、總務和行政，相關方 | 30 | 193 | (163 | ) | ||||||||
| 研究 與發展 | 1,306 | 44 | 1,262 | |||||||||
| 按公允價值計算的條件性支付變動 | - | 100 | (100 | ) | ||||||||
| 營業費用總額 | 40,260 | 42,287 | (2,027 | ) | ||||||||
| 營運損失 | (15,498) | (18,812 | ) | 3,314 | ||||||||
| 按公允價值計算的認股權負債變動 | 1,329 | 2,001 | (672 | ) | ||||||||
| 按公允價值計算的投資變動，相關方 | (12 | ) | (6,635 | ) | 6,623 | |||||||
| 債務清償損失 | (316 | ) | - | (316 | ) | |||||||
| 利息 費用，淨額 | (1,995 | ) | (256 | ) | (1,739 | ) | ||||||
| 其他損益淨額 | 154 | 65 | 89 | |||||||||
| 所得稅前損失 | (16,338 | ) | (23,637 | ) | 7,299 | |||||||
| 所得稅費用 | 25 | 20 | 5 | |||||||||
| 淨 損失 | $ | (16,363 | ) | $ | (23,657 | ) | $ | 7,294 | ||||
產品 營業收入，淨額
2024年9月30日結束的九個月，淨產品收入較2013年9月30日結束的九個月增長130萬美元，增幅為5.6%。這一增長主要是由於Ameluz平均銷售價格增加110萬美元所驅動，這是2024年9月30日結束的九個月中設備銷售增加60萬美元，這主要歸因於2024年6月推出的RhodoLED產品。® 2024年6月推出的XL燈具抵消了Ameluz大約50萬美元的銷售量減少。® 由於颶風米爾頓引起的辦公室關閉和運輸延誤，Ameluz的銷售量減少成本約50萬美元。如上所述，這些延遲的貨物已經交付，並且在第四季度確認了收入。
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Operating Expenses
Cost of Revenues, Related Party
Cost of revenues, related party for the nine months ended September 30, 2024 increased by $1.0 million, or 8.7% as compared to the nine months ended September 30, 2023. This was driven by the increase in both Ameluz® and RhodoLED® XL Lamp product revenue.
Selling, General and Administrative Expenses
Selling, general and administrative expenses for the nine months ended September 30, 2024 decreased by $4.3 million, or 14.3% as compared to the nine months ended September 30, 2023. The decrease was primarily driven by a $1.7 million decrease in legal costs due to the settlement with Biofrontera AG in April 2023, a $1.3 million decrease of non-personnel sales and marketing expenses due to a lower level of marketing activities in general, a $0.6 million decrease in general business administration, and a net decrease of $0.6 million in personnel expenses, partially offset by costs relating to the complaints filed by SUN.
Research and Development Expenses
R&D expenses for the nine months ended September 30, 2024 increased by $1.3 million as compared to the nine months ended September 30, 2023. The increase was attributable to our assumption of all clinical trial activities for Ameluz® in the United States effective June 1, 2024. The following table summarizes our research and development expenses:
| Nine Months Ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| Actinic keratosis | $ | 338 | $ | - | ||||
| Moderate to severe acne | 221 | - | ||||||
| Superficial basal cell carcinoma | 153 | - | ||||||
| Portable devices | 83 | - | ||||||
| Personnel-related costs | 435 | - | ||||||
| Other research and development | 76 | 44 | ||||||
| $ | 1,306 | $ | 44 | |||||
Change in Fair Value of Warrant Liabilities
The change in fair value of warrant liabilities was $1.3 million for nine months ended September 30, 2024, as compared to $2.0 million for the nine months ended September 30, 2023. The change in fair value of warrant liabilities was driven primarily by a decrease in the underlying value of the Company’s Common Stock paired with a higher population of warrants outstanding for the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023.
Change in Fair Value of Investment, Related Party
As of December 31, 2023, the Company had transferred substantially all of its investment in Biofrontera AG to Maruho in exchange for the release of certain obligations, in accordance with the Release. As a result, during the third quarter of 2024, the net balance of our investment in Biofrontera AG was minimal as was the related change in fair value.
Loss on Debt Extinguishment
Effective as of January 4, 2024, we voluntarily terminated the Loan Agreement with Midcap Business Credit LLC. The Company recognized a $0.3 million loss on debt extinguishment upon the early termination of the Loan Agreement related to prepayment fees and the write-off of deferred financing costs.
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Interest income (expense), net
The increase of interest expense of $1.7 million was driven by the interest and debt discount recognized on the loans issued on December 21, 2023, for an aggregate principal balance of $4.0 million. The loans required the Company to make weekly payments of principal and interest in the amount of approximately $0.2 million through July 5, 2024, the maturity date. Interest expense was recognized using the effective interest method, such that a constant effective interest rate was applied to the carrying amount of the debt at the beginning of each period until maturity.
Net Loss to Adjusted EBITDA Reconciliation for the Three and Nine Months Ended September 30, 2024 and 2023
We define adjusted EBITDA as net income or loss before interest income and expense, income taxes, depreciation and amortization, and other non-operating items from our statements of operations as well as certain other items considered outside the normal course of our operations specifically described below. Adjusted EBITDA is not a presentation made in accordance with U.S. GAAP. Our definition of adjusted EBITDA may vary from the use of similarly-titled measures by others in our industry due to the potential inconsistencies in the method of calculation and differences due to items subject to interpretation. Adjusted EBITDA should not be considered as an alternative to net income or loss, operating income/(loss), cash flows from operating activities or any other performance measures derived in accordance with U.S. GAAP as measures of operating performance or liquidity. Adjusted EBITDA has limitations as an analytical tool and should not be considered in isolation or as a substitute for analysis of our results as reported under U.S. GAAP.
Loss on debt extinguishment: Effective as of January 4, 2024, we voluntarily terminated the Loan Agreement and recognized a $0.3 million loss on debt extinguishment upon the early termination of the loan. We exclude the impact of this loss as it is attributed to the prepayment fee, which is considered non-recurring, and the write-off of deferred financing costs, which is considered non-cash.
Change in fair value of contingent consideration: Pursuant to a share purchase agreement with Maruho, the profits from the sale of Cutanea products were to be shared equally between Maruho and Biofrontera until 2030. The fair value of the contingent consideration was determined to be $6.5 million on the acquisition date and was re-measured at each reporting date. We exclude the historical impact of the change in fair value of contingent consideration as this is non-cash. We were relieved of our obligations relating to the contingent consideration under the Release. As such, our results of operations for the three and nine months ended September 30, 2024 were not impacted by the change in fair value.
Change in fair value of warrant liabilities: The warrants issued in conjunction with our private placement offerings and registered public offerings are accounted for as liabilities in accordance with ASC 815-40. The warrant liabilities are measured at fair value at inception and on a recurring basis, with changes in fair value presented within the consolidated statement of operations. We exclude the impact of the change in fair value of warrant liabilities as this is non-cash.
Change in fair value of investment, related party: The Company accounts for its investment, related party in accordance with ASC 321, Investments — Equity Securities. Equity securities, which are comprised of investments in common stock, are initially recorded at cost, plus transaction costs, and subsequently measured at fair value, based on quoted market prices, with the gains and losses reported in the Company’s consolidated statement of operations. For the investments held in foreign currencies, the change in fair value attributable to changes in foreign exchange rates is included in gains and losses in the consolidated statement of operations. We exclude the impact of the realized gain as this is non-recurring and the unrealized change in fair value of investments is excluded as this is non-cash.
Legal settlement expenses: To measure operating performance, we exclude legal settlement expenses. We do not expect to incur these types of legal expenses on a recurring basis and believe the exclusion of such amounts allows management and the users of the financial statements to better understand our financial results.
Stock-Based Compensation: To measure operating performance, we exclude the impact of costs relating to share-based compensation. Due to the subjective assumptions and the variety of award types, we believe that the exclusion of share-based compensation expense, which is non-cash, allows for more meaningful comparisons of our operating results to peer companies. Share-based compensation expense can vary significantly based on the timing, size and nature of awards granted.
Expensed issuance costs: To measure operating performance, we exclude the portion of issuance costs allocated to our warrant liabilities. We do not expect to incur this type of expense on a recurring basis and believe the exclusion of these costs allows management and the viewers of the financial statements to better understand our financial results.
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Adjusted EBITDA margin is adjusted EBITDA for a particular period expressed as a percentage of revenues for that period.
We use adjusted EBITDA to measure our performance from period to period and to compare our results to those of our competitors. In addition to adjusted EBITDA being a significant measure of performance for management purposes, we also believe that this presentation provides useful information to investors regarding financial and business trends related to our results of operations and that when non-U.S. GAAP financial information is viewed with U.S. GAAP financial information, investors are provided with a more meaningful understanding of our ongoing operating performance.
The table below presents a reconciliation from net loss to Adjusted EBITDA for the three and nine months ended September 30, 2024 and 2023:
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Net loss | $ | (5,669 | ) | $ | (6,342 | ) | $ | (16,363 | ) | $ | (23,657 | ) | ||||
| Interest expense, net | (8 | ) | 142 | 1,995 | 256 | |||||||||||
| Income tax expenses | 3 | 1 | 25 | 20 | ||||||||||||
| Depreciation and amortization | 129 | 251 | 387 | 769 | ||||||||||||
| EBITDA | (5,545 | ) | (5,948 | ) | (13,956 | ) | (22,612 | ) | ||||||||
| Loss on debt extinguishment | - | - | 316 | - | ||||||||||||
| Change in fair value of contingent consideration | - | 200 | - | 100 | ||||||||||||
| Change in fair value of warrant liabilities | 680 | (598 | ) | (1,329 | ) | (2,001 | ) | |||||||||
| Change in fair value of investment, related party | 2 | 2,212 | 12 | 6,635 | ||||||||||||
| Legal settlement expenses | - | - | - | 1,225 | ||||||||||||
| Stock based compensation | 288 | 207 | 720 | 817 | ||||||||||||
| Expensed issuance costs | - | - | 354 | - | ||||||||||||
| Adjusted EBITDA | $ | (4,575 | ) | $ | (3,927 | ) | $ | (13,883 | ) | $ | (15,836 | ) | ||||
| Adjusted EBITDA margin | -50.8 | % | -44.1 | % | -56.1 | % | -67.5 | % | ||||||||
Adjusted EBITDA
Adjusted EBITDA decreased from ($3.9) million for the three months ended September 30, 2023 to ($4.6) million for the three months ended September 30, 2024. The decrease was primarily driven by an increase in R&D expenses of $0.6 million.
Adjusted EBITDA increased from ($15.8) million during the nine months ended September 30, 2023 to ($13.9) million for the nine months ended September 30, 2024. The increase in Adjusted EBITDA was primarily driven by a decrease in selling, general and administrative expenses of $3.2 million, due primarily to a decreased level of marketing activities and savings in legal expenses. This is partially offset by an increase in R&D expense of $1.3 million.
Liquidity and Capital Resources
Pursuant to the requirements of the Financial Accounting Standards Board’s Accounting Standards Codification (“ASC”) Topic 205-40, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern, management must evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern for one year from the date the consolidated financial statements are issued. This evaluation does not take into consideration the potential mitigating effect of management’s plans that have not been fully implemented or are not within control of the Company as of the date the financial statements are issued. When substantial doubt exists under this methodology, management evaluates whether the mitigating effect of its plans sufficiently alleviates substantial doubt about the Company’s ability to continue as a going concern. The mitigating effect of management’s plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued, and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the consolidated financial statements are issued.
Since we commenced operations in 2015, we have generated significant losses. We incurred net cash outflows from operations of $9.3 million and $16.0 million for the nine months ended September 30, 2024 and 2023, respectively. The Company had an accumulated deficit as of September 30, 2024 of $116.0 million. The Company’s primary sources of liquidity are its cash collected from the sales of its products, and cash flows from financing transactions. As of September 30, 2024, we had cash and cash equivalents of $2.9 million, compared to $1.3 million as of December 31, 2023.
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As a result of our losses and projected cash needs, the Company’s management has determined that substantial doubt exists about our ability to continue as a going concern for at least twelve months from the issuance date of these financial statements. The Company’s ability to continue as a going concern is contingent upon successful execution of management’s intended plan over the next twelve months to improve the Company’s liquidity and profitability, which includes without limitation:
| ● | Expanding the commercialization of Ameluz® in the United States while decreasing discretionary expenses. | |
| ● | Actively pursuing additional capital through the issuance of equity securities, debt or the sale of assets. | |
| ● | Controlling expenses and limiting capital expenditures. | |
| ● | Realizing the benefit of the reduced cost of inventory in line with the terms of the Second A&R Ameluz LSA. |
The company believes that the implementation of such plans will provide the opportunity for the Company to continue as a going concern. However, no assurance can be given that the Company will be successful in these efforts and will depend on several factors, including executing on its sales plan and planned cost reductions within the time period needed, as well as other possible challenges and unforeseen circumstances. A lack of execution or unforeseen circumstances may require the Company to raise additional capital or debt which may not be available on acceptable terms, or at all, which could result in a material adverse effect on the Company, as well as its business, financial condition, results of operations, growth prospects and financial statements.
The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above.
Cash Flows
The following table summarizes our cash provided by and (used in) operating, investing and financing activities:
| Nine Months Ended September 30, | ||||||||
| (in thousands) | 2024 | 2023 | ||||||
| Net cash used in operating activities | $ | (9,253 | ) | $ | (16,029 | ) | ||
| Net cash provided by (used) in investing activities | (2 | ) | 546 | |||||
| Net cash provided by financing activities | 10,785 | 1,697 | ||||||
| Net increase (decrease) in cash and restricted cash | $ | 1,530 | $ | (13,786 | ) | |||
Operating Activities
During the nine months ended September 30, 2024, operating activities used $9.3 million of cash, primarily resulting from our loss from operations of $16.4 million, adjusted for non-cash expense of stock-based compensation of $0.7 million, non-cash interest expense of $0.2 million, loss on debt extinguishment of $0.3 million, depreciation and amortization in the aggregate of $0.9 million, and net cash used by changes in our operating assets and liabilities of $6.1 million, offset by the change in fair value of warrant liabilities of $1.3 million,.
During the nine months ended September 30, 2023, operating activities used $16.0 million of cash, primarily resulting from our loss from operations of $23.7 million, adjusted for non-cash expense of stock-based compensation of $0.8 million, non-cash interest expense of $0.3 million, depreciation and amortization in the aggregate of $0.8 million, net cash used by changes in our operating assets and liabilities of $0.9 million, the change in fair value of contingent consideration of $0.1 million and the change in fair value of investment, related party of $6.6 million; partially offset by the change in fair value of warrant liabilities of $2.0 million.
Investing Activities
During the nine months ended September 30, 2024, net cash used in investing activities consisted of $0.1 million of capitalized software and computer purchases, which were partially offset by the proceeds from the sales of equity investments.
During the nine months ended September 30, 2023, net cash provided by investing activities of $0.5 million consisted of the proceeds from the sales of equity investments of $0.6 million, partially offset by the purchase of machinery and computer equipment.
Financing Activities
During the nine months ended September 30, 2024, net cash from financing activities consisted of proceeds of $7.7 million, net of capitalized issuance costs, from the issuance of preferred stock and warrants, and $7.4 million from the exercise of warrants for preferred stock, offset by repayments of $4.0 million on our short-term loan, repayments of $0.2 million on our line of credit and prepayment fees of $0.2 million to extinguish our line of credit. See Note 10 Debt.
During the nine months ended September 30, 2023, net cash from financing activities consisted of a net $1.7 million of proceeds from our line of credit.
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Accounting Policies and Significant Judgments and Estimates
Our management’s discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with generally accepted accounting principles of the United States, or U.S. GAAP. The preparation of the financial statements in accordance with U.S. GAAP requires the use of estimates and assumptions by management that affect the value of assets and liabilities, as well as contingent assets and liabilities, as reported on the balance sheet date, and revenues and expenses arising during the reporting period. The main areas in which assumptions, estimates and the exercising of a degree of judgment are appropriate relate to contingent consideration, fair value measurements, valuation of intangible assets and impairment assessment, and stock compensation. Estimates are based on historical experience and other assumptions that are considered appropriate in the circumstances. They are continuously reviewed but may vary from the actual values.
Our significant accounting policies are described in more detail in Note 2 – Summary of Significant Accounting Policies, to our consolidated financial statements included in Item 8. Financial Statements and Supplementary Data in our Form 10-K.
Critical Accounting Estimates
A summary of our critical accounting estimates is discussed in the section entitled “Critical Accounting Estimates” in Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Form 10-K. There were no material changes to our critical accounting estimates for the nine months ended September 30, 2024, except for the following:
The warrants for convertible preferred stock issued in conjunction with our private placement offering conducted pursuant to the securities purchase agreements entered into on February 19, 2024 with institutional investors were accounted for as liabilities in accordance with ASC 815-40 and are presented within warrant liabilities in the accompanying consolidated balance sheet. The warrant liabilities are measured at fair value at inception and on a recurring basis, with changes in fair value presented within the consolidated statement of operations. Due to the uncertainty of the how the convertible preferred warrants would ultimately settle, the Company used a probability-weighted approach along with a Black-Scholes-Merton (“BSM”) model equation to estimate the fair value of the preferred warrants under different scenarios. While we believe these assumptions were reasonable, the manner or timeframe in which the warrants ultimately settle may differ. The BSM model also considers several variables and assumptions in estimating the fair value of financial instruments, including the per-share fair value of the underlying common stock, exercise price, expected term, risk-free interest rate, expected stock price volatility over the expected term, and expected annual dividend yield. Certain inputs utilized in our BSM pricing model may fluctuate in future periods based upon factors which are outside of the Company’s control. A significant change in one or more of these inputs used in the calculation of the fair value may have caused a significant change to the fair value of our warrant liability which could also have resulted in material non-cash gain or loss being reported in our consolidated statement of operations.
Off-balance Sheet Arrangements
Other than those items reflected in Note 17. Commitments and Contingencies we did not have during the periods presented, and we do not currently have, any other off-balance sheet arrangements, as defined in the rules and regulations of the SEC.
Emerging Growth Company Status
The Jumpstart Our Business Startups Act of 2012 permits an “emerging growth company” such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. We have elected to take advantage of such extended transition period, which means that when an accounting standard is issued or revised and it has different application dates for public or private companies, we will adopt the new or revised standard at the time private companies adopt the new or revised standard and will do so until such time that we either (i) irrevocably elect to “opt out” of such extended transition period or (ii) no longer qualify as an emerging growth company.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
As a “smaller reporting company,” we are not required to provide the information required by this Item.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated, as of the end of the period covered by this Form 10-Q, the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934 (the “Exchange Act”)). Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of September 30, 2024, our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting during the most recent fiscal quarter ended September 30, 2024 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act).
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PART II. OTHER INFORMATION
Item 1. Legal Proceedings
For information regarding legal proceedings in which we are involved, (see Note 17. Commitments and Contingencies under the subsection titled “Legal Proceedings” in our Notes to Consolidated Financial Statements in Part I, Item 1 of this Quarterly Report on Form 10-Q).
Item 1A. Risk Factors
As a smaller reporting company, we are not required to provide disclosure pursuant to this item in this Form 10-Q. However, as of the date of this Quarterly Report, other than as set forth below, there have been no material changes with respect to those risk factors previously disclosed under “Risk Factors” included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as filed with the Securities and Exchange Commission on March 15, 2024 (the “Form 10-K”). The following should be carefully considered, together with other information in this Quarterly Report on Form 10-Q, our Form 10-K, and our other filings with the SEC before making investment decisions regarding our common stock.
There is substantial doubt about our ability to continue as a “going concern.”
In connection with our assessment of going concern considerations under applicable accounting standards, the Company’s management has determined that substantial doubt exists about our ability to continue as a going concern through approximately one year from the date the unaudited condensed financial statements included in Item 1. “Financial Statements” were issued. The future viability of the Company is dependent on its ability to continue to execute its growth plan and raise additional capital or find alternative methods of financing to fund its operations. There can be no guarantee that the actions presently being taken by the Company will be successful in raising additional capital or finding alternative methods of financing. If the Company is not successful in these endeavors, it would likely have a material adverse effect on the Company’s business, results of operations and financial condition.
For additional discussion of the risks and uncertainties that affect our business, see “Item 1A. Risk Factors” included in our Form 10-K.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not Applicable.
Item 5. Other Information
None.
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Item 6. Exhibits
The following exhibits are filed herewith or are incorporated by reference to exhibits previously filed with the SEC.
| * | Filed herewith. |
| # | Indicates a management contract or compensatory plan or arrangement. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| BIOFRONTERA INC. | ||
| Date: November 14, 2024 | By: | /s/ Hermann Luebbert |
| Name: | Hermann Luebbert | |
| Title: | Chief Executive Officer & Chairman (Principal Executive Officer) | |
| Date: November 14, 2024 | By: | /s/ E. Fred Leffler III |
| Name: | E. Fred Leffler, III | |
| Title: | Chief Financial Officer (Principal Financial Officer) | |
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