VALENCIA, Calif., Sept. 10, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a commercial-stage regenerative medicine company focused on first-in-class devices for wound care management and skin restoration, today announced that management will participate in Lake Street Capital Markets’ 8th Annual Best Ideas Growth (BIG8) Conference in New York on September 12, 2024. Jim Corbett, Chief Executive Officer, will host one-on-one meetings with institutional investors throughout the day. Fo ...

D-Keine Introduction AVITA Medical, Inc. (NASDAQ:RCEL) stock is down 47% since my last look in March. The title said it all: “Unconvincing Growth Amid Fierce Competition In The Burn Care Sector.” My recommendation was hold, citing “unresolved concerns over S&M spending efficiency and competitive advantage.” The company subsequently has released two earnings reports and launched RECELL GO, so let's take another look. AVITA Medical: Struggling to Balance Growth and Profitability RECELL GO was FDA-approved ...

NASDAQ: RCEL ASX: AVH Q2 2024 Earnings Presentation August 8, 2024 Forward-Looking Statements & Legal Disclaimers This presentation and the accompanying oral commentary are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this presentation, including statements regarding our future financial condition, technology platform, development strategy, prospective products, pipeline and mile ...

财务表现 - 公司第二季度总收入为26,299千美元，同比增长18.0%[23] - 第二季度毛利为22,675千美元，毛利率为86.2%[23] - 第二季度销售和营销费用为28,942千美元，同比增长75.0%[23] - 第二季度研发费用为10,081千美元，同比增长4.3%[23] - 第二季度净亏损为34,051千美元，每股亏损1.32美元[23] - 公司预计未来将加大市场拓展和并购力度，以提升市场份额和盈利能力[1,2,14,15] - 公司对未来业绩保持谨慎乐观态度，将继续优化成本结构，提高运营效率[1,2,14,15] 现金流与资产负债 - 截至2024年6月30日，公司现金及现金等价物余额为23,915千美元[34] - 公司持有大量现金和现金等价物,包括存放在金融机构的现金和货币市场基金[52] - 公司的金融工具可能面临信用风险集中,包括现金和现金等价物、有价证券、应收账款以及债务和其他负债[53] - 公司于2023年10月18日与OrbiMed Advisors签订5年期9,000万美元信贷协议,首次提款4,000万美元[103] - 公司所有债务由其全资子公司担保，并由公司及担保人的几乎所有资产作为抵押[104] - 公司选择采用公允价值选择权记录长期债务和认股权证，公允价值变动计入合并损益表的其他收益[110] - 公司截至2024年6月30日的固定资产净值为70.24百万美元[128] - 2024年6月30日的在建工程主要包括维纳工厂的装修改造和RECELL GO RPD的制造材料[129] 收入确认 - 公司主要收入来自于RECELL EOU、RPK和PermeaDerm产品的销售[55] - 公司从BARDA获得维护费用以确保对公司库存的优先使用权[56] - 公司出租RPD产生租赁收入[56] - 公司的RECELL EOU和PermeaDerm产品销售收入根据ASC 606准则确认[57] - 公司根据ASC 606和ASC 842准则确认RECELL GO系统的收入[57] - 公司与第三方分销商合作,收入在分销商取得产品控制权时确认[95] - PermeaDerm产品销售毛利率为50%,公司与Stedical Scientific平分收入[96] 新产品与研发 - 第二季度公司新产品销售收入为15,183千美元，同比增长29.1%[23] - 第二季度公司新技术研发投入为4,887千美元，占总收入的18.6%[23] - 公司的RECELL GO系统引入了增强功能,简化了Spray-On Skin Cells的制备过程,提高了手术室的工作效率[41] - 公司于2024年7月31日与Regenity Biosciences签订了一项5年期的独家开发和分销协议，涉及一种新型胶原蛋白皮肤支架产品[165] 会计政策与估计 - 公司正在评估近期发布的新会计准则对其合并财务报表和披露的影响[45][46][47] - 公司使用了多项估计和假设来编制财务报表,实际结果可能与估计存在差异[48] - 公司的非美国子公司使用当地货币作为功能货币,资产负债表项目按期末汇率折算,收支项目按平均汇率折算[49] - 公司的非经营子公司使用美元作为功能货币,货币性资产负债按期末汇率折算,非货币性项目按历史汇率折算[50] - 公司记录了一些外币收入和费用,按平均汇率折算为美元[51] 合同会计 - 公司与客户签订的合同需要满足5个步骤来确认收入[58][59][60][61][62] - 公司合同中包含租赁部分和非租赁部分,需要分别根据ASC 842和ASC 606准则确认收入[63][64][65][66] - RECELL GO设备的收入分为两部分:RPK销售收入和RPD租赁收入[94] - 未完成履约义务合同负债为545,000美元,主要来自COSMOTEC和其他客户[97] - 公司没有合同资产,合同负债主要为COSMOTEC未完成履约义务374,000美元[98,99] 股权激励 - 截至2024年6月30日，公司共有384.3万份股票期权，其中包括362.6万份服务期限型股票期权和21.7万份业绩型股票期权[148] - 截至2024年6月30日，公司共有21.4万份未解锁的受限股单位(RSU)，其中包括19.2万份服务期限型RSU和2.3万份业绩型RSU[150] - 公司于2023年6月推出了员工股票购买计划(ESPP)，2024年上半年确认了41.8万美元的ESPP费用[152] 员工福利 - 公司为员工提供401(k)计划和非合格递延薪酬计划(NQDC)，2024年上半年公司为此支付了140万美元和67,000美元[157,158]

财务业绩 - 第二季度商业收入达到创纪录的1510万美元，同比增长约29%[1][2] - 2022年全年总收入为262.99亿美元，同比增长18%[22] - 2022年全年毛利润为226.75亿美元，同比增长23%[22] - 2021年第四季度总收入为151.95亿美元，同比增长29%[22] - 2021年第四季度毛利润为130.84亿美元，同比增长37%[22] 盈利能力 - 毛利率为86.2%[1][8] - 预计最迟于2025年第三季度实现现金流平衡和GAAP盈利[1][5] - 2022年全年净亏损为340.51亿美元，每股亏损1.32美元[22] - 2021年第四季度净亏损为153.93亿美元，每股亏损0.60美元[22] 费用情况 - 2022年全年销售和营销费用为289.42亿美元，同比增加75%[22] - 2022年全年研发费用为100.81亿美元，同比增加4%[22] - 2021年第四季度销售和营销费用为163.02亿美元，同比增加63%[22] - 2021年第四季度研发费用为48.87亿美元，同比下降4%[22] 产品进展 - RECELL GO™获FDA批准上市，首例手术于5月31日完成[1][2] - 提交RECELL GO mini™的PMA补充申请，获得突破性医疗器械认定，确保优先180天互动审查期[1][2] - 与Regenity Biosciences签订独家开发和分销协议，获得一种独特胶原蛋白基底皮肤基质的商业化权利[1][2] 其他收益 - 其他收益净额增加80万美元至160万美元，主要来自于公允价值变动收益[1][12] 业绩预期 - 预计第三季度商业收入将增长40%至48%，全年收入增长37%至41%[1][5][6]

VALENCIA, Calif., July 11, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a commercial-stage regenerative medicine company focused on first-in-class devices for wound care management and skin restoration, today announced that it will report its second quarter 2024 financial results after the close of the U.S. financial markets on Thursday, August 8, 2024. AVITA Medical will host a conference call and webcast that day at 1:30 p.m. Pacific Time (Friday, August 9, 2024, at 6:30 a.m. Aus ...

VALENCIA, Calif., July 01, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a commercial-stage regenerative medicine company focused on first-in-class devices for wound care management and skin restoration, today announced the appointment of Nicole Linda Kelsey as Chief Legal and Compliance Officer, and Corporate Secretary, effective July 1, 2024. Ms. Kelsey has more than two decades of executive legal experience with expertise in M&A, securities, and governance, along with a strong tr ...

VALENCIA, Calif., June 05, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a commercial-stage regenerative medicine company focused on first-in-class devices for wound care management and skin restoration, today announced that the Joseph M. Still Burn Center at Doctors Hospital of Augusta is the first U.S. burn center to treat a patient using its RECELL GO™ System. Recently FDA- approved, RECELL GO is a next-generation autologous cell harvesting device that harnesses the regenerative ...

VALENCIA, Calif., June 05, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a commercial-stage regenerative medicine company focused on first-in-class devices for wound care management and skin restoration, today announced that the Joseph M. Still Burn Center at Doctors Hospital of Augusta is the first U.S. burn center to treat a patient using its RECELL GO™ System. Recently FDA- approved, RECELL GO is a next-generation autologous cell harvesting device that harnesses the regenerative ...

VALENCIA, Calif., May 30, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a commercial-stage regenerative medicine company focused on first-in-class devices for wound care management and skin restoration, today announced that the U.S. Food and Drug Administration (FDA) has approved its premarket approval (PMA) supplement for the RECELL GO™ System, its next-generation autologous cell harvesting device that harnesses the regenerative properties of a patient’s own skin to treat thermal b ...