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BIOLASE(BIOL) - 2022 Q4 - Annual Report
2023-03-28 00:00
全球口腔激光设备市场 - 全球口腔激光设备市场预计2022年达到106亿美元,年复合增长率为6.2%[12] - 美国约有20.2万名执业牙医,全球口腔激光系统市场渗透率仅为7-8%[12] 产品认可与应用 - Waterlase全组织激光系统已获得美国FDA认可,欧洲CE标志,适用于80多个国家的牙科用途[14] - Diode软组织激光系统Epic X、Epic Hygiene和Epic 10已获得美国FDA认可,欧洲CE标志,适用于80多个国家的牙科用途[14] - BIOLASE与EdgeEndo合作开发的EdgePro激光设备已获得美国FDA认可,用于清洁和消毒根管[14] 临床效果与患者体验 - 扩大了牙科专业人员的手术范围[18] - 减少了患者就诊次数,提高了患者服务效率[19] - 提高了病例接受率和患者报告的结果[20] - 改善了临床结果,减少了患者的不适感[21] - Waterlase全组织激光系统产生的气溶胶比传统牙科手持式设备少98%[22] - Waterlase系统允许在许多情况下无需麻醉进行微创牙科手术[24] - Waterlase系统减少了患者的创伤,加快了康复速度[26] 销售与市场拓展 - 加强销售和分销能力,扩大国内和国际市场[32] - 通过OEM合作伙伴关系实现收入增长[38] - 2022年,国际收入占总收入的30%,2021年为35%,2020年为29%[42] - 2022年,最大的全球分销商销售占总收入的4%[43] 专利与法规合规 - 截至2022年底,公司拥有约259项有效专利和24项待定专利[45] - 公司的核心技术相关专利将在2023年到期,其余专利将在2025年至2042年间到期[46] - 公司产品在美国市场上市时需获得510(k)预市场清关[49] - FDA对医疗设备的监管要求严格,包括产品清单和注册要求,设备制造商必须遵守详细的cGMP要求[50] - FDA要求医疗设备制造商遵守售后监测、投诉处理和不良事件报告规定,包括医疗器械报告要求[50] - 在欧盟市场,医疗设备必须符合所有法规要求并贴有CE标志,不同类别的设备需要通过不同的授权程序[51] 公司治理与管理团队 - 公司的执行官包括总裁兼首席执行官John R. Beaver,首席财务官Jennifer Bright和首席运营官Steven Sandor[64] - John R. Beaver曾担任Silicor Materials, Inc.的首席财务官,Modumetal, Inc.的首席财务官,并在Sterling Chemicals担任财务副总裁和首席财务官[65] - Jennifer Bright拥有超过25年的专业会计和财务经验,曾在多家公司担任高级会计总监和控制器[65] - Steven Sandor拥有查普曼大学的工商管理硕士学位,曾在KaVo Kerr担任全球培训总监[65] 风险与挑战 - 公司连续三年出现净亏损,未来可能继续亏损并难以实现盈利[70] - 公司高度敏感于全球经济不确定性和金融市场波动,经济衰退和金融市场紊乱可能对公司业务、财务状况和运营结果产生重大不利影响[70] - 公司的未来成功将取决于向广泛的牙医和患者展示其激光系统相对于传统治疗方法和竞争对手激光系统的潜在性能优势[73] - 公司的净经营亏损结转可能受到限制,未来利用这些税收优惠的能力取决于公司在NOL结转到期日期之前是否能够产生足够的应税收入[74] - 公司必须扩大制造能力以满足潜在需求,但在增加产品生产方面可能会遇到困难,包括生产能力和产量、质量控制和保证、零部件供应以及合格人员短缺等问题[76]
BIOLASE(BIOL) - 2022 Q3 - Earnings Call Transcript
2022-11-11 09:19
BIOLASE, Inc. (NASDAQ:BIOL) Q3 2022 Earnings Conference Call November 10, 2022 4:30 PM ET Company Participants Todd Kehrli - Investor Relations John Beaver - President and Chief Executive Officer Jennifer Bright - Chief Financial Officer Conference Call Participants Kyle Bauser - Lake Street Capital Markets Anthony Vendetti - the Maxim Group Bruce Jackson - The Benchmark Company Operator Good day and welcome to the BIOLASE Third Quarter 2022 Financial Results Conference Call. Please note, this call is being ...
BIOLASE(BIOL) - 2022 Q3 - Quarterly Report
2022-11-10 00:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading symbol(s) Name of each exchange on which registered Common stock at par value $0.001 per share BIOL The NASDAQ Stock Market LLC (NASDAQ Capital Market) FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transiti ...
BIOLASE(BIOL) - 2022 Q2 - Earnings Call Transcript
2022-08-12 10:25
BIOLASE, Inc. (OTCQB:BIOL) Q2 2022 Earnings Conference Call August 11, 2022 4:30 PM ET Company Participants Todd Kehrli - EVC Group John Beaver - President, CEO & Director Jennifer Bright - CFO Conference Call Participants Kyle Bauser - Lake Street Capital Markets Anthony Vendetti - Maxim Group Ed Woo - Ascendiant Capital Markets Operator Good day, and welcome to the BIOLASE Second Quarter 2022 Financial Results Conference Call. [Operator Instructions]. Please note, this event is being recorded. I would now ...
BIOLASE(BIOL) - 2022 Q2 - Quarterly Report
2022-08-11 00:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading symbol(s) Name of each exchange on which registered Common stock at par value $0.001 per share BIOL The NASDAQ Stock Market LLC (NASDAQ Capital Market) FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition pe ...
BIOLASE(BIOL) - 2022 Q1 - Earnings Call Presentation
2022-05-16 09:47
| --- | --- | --- | --- | --- | |-------|-------|-------------------------------------------------------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | RIOT AS | | | | | | | | | | | | | \| ® | | | | | :: Advancing Dentistry | | | | | | | | | | | | Investor Overview NASDAQ : BIOL \| HIMMAN \| MAY 2022 | | | Safe Harbor Statement Statements made in this presentation and during discussions with BIOLASE representative's that refer to BIOLASE's estimated or anticipated future ...
BIOLASE(BIOL) - 2022 Q1 - Earnings Call Transcript
2022-05-13 10:14
BIOLASE, Inc. (OTCQB:BIOL) Q1 2022 Earnings Conference Call May 12, 2022 4:30 PM ET Company Participants Todd Kehrli - Investor Relations, EVC Group John Beaver - President and Chief Executive Officer Jennifer Bright - Vice President of Finance Conference Call Participants Bruce Jackson - The Benchmark Company Matt Bullock - Maxim Group Kyle Bauser - Lake Street Operator Good day, and welcome to the BIOLASE First Quarter 2022 Results Conference Call. All participants will be in a listen-only mode. [Operato ...
BIOLASE(BIOL) - 2022 Q1 - Quarterly Report
2022-05-12 00:00
4 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading symbol(s) Name of each exchange on which registered FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: ...
BIOLASE(BIOL) - 2021 Q4 - Earnings Call Transcript
2022-03-18 06:44
BIOLASE, Inc. (OTCQB:BIOL) Q4 2021 Earnings Conference Call March 17, 2022 4:30 PM ET Company Participants Todd Kehrli - IR, EVC Group John Beaver - President and Chief Executive Officer Jennifer Bright - Vice President, Finance Conference Call Participants Bruce Jackson - Benchmark Company Matthew Bullock - Maxim Group Ed Woo - Ascendiant Capital Disclaimer*: This transcript is designed to be used alongside the freely available audio recording on this page. Timestamps within the transcript are designed to ...
BIOLASE(BIOL) - 2021 Q4 - Earnings Call Presentation
2022-03-18 05:29
| --- | --- | --- | |-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Safe Harbor Statement Statements made in this presentation and during discussions with BIOLASE representative's that refer to BIOLASE's estimated or anticipated future results or other non-historical facts are forward-looking statements, as are any statements its representatives make concerning BIOLASE's strategic initiatives, anticipated financial performance and product lau ...