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OptiNose(OPTN) - 2024 Q1 - Quarterly Report
2024-05-14 21:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 ☐ 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: 001-38241 OPTINOSE, INC. (Exact name of registrant as specified in its charter) Delaware 42-1771610 (State ...
OptiNose(OPTN) - 2024 Q1 - Quarterly Results
2024-05-14 19:08
Building a Leading ENT / Allergy Specialty Company Commercial Launch Call April 25, 2024 2 Forward-Looking Statements This presentation and our accompanying remarks contain “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. All statements that are not historical facts are hereby identified as forward-looking statements for this purpose and include, among others, statements relating to: the potential benefits of the recent FDA approval of XHANCE for ...
Optinose Announces Reporting Date for First Quarter 2024 Financial Results
Newsfilter· 2024-05-11 02:56
YARDLEY, Pa., May 10, 2024 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced the Company will report financial results for the first quarter 2024 and corporate updates, before market open, on Tuesday, May 14, 2024. Company to Host Conference Call Members of the Company's leadership team will host a conference call to discuss financial results and corporate updates. The call is scheduled to s ...
Optinose Announces Reporting Date for First Quarter 2024 Financial Results
GlobeNewsWire· 2024-05-11 02:56
YARDLEY, Pa., May 10, 2024 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced the Company will report financial results for the first quarter 2024 and corporate updates, before market open, on Tuesday, May 14, 2024. Company to Host Conference Call Members of the Company's leadership team will host a conference call to discuss financial results and corporate updates. The call is scheduled to s ...
OptiNose(OPTN) - 2023 Q4 - Earnings Call Presentation
2024-03-07 22:15
Building a Leading ENT / Allergy Specialty Company C o r p o rate P re s e ntat io n M a rc h 7 , 2 0 2 4 Forward-Looking Statements This presentation and our accompanying remarks contain “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. All statements that are not historical facts are hereby identified as forward-looking statements for this purpose and include, among others, statements relating to: the generation of XHANCE prescriptions and net re ...
OptiNose(OPTN) - 2023 Q4 - Earnings Call Transcript
2024-03-07 22:14
财务数据和关键指标变化 - 公司在2023年第四季度实现了约19.9百万美元的XHANCE净收入,较2022年同期下降5% [24] - 2023年全年XHANCE净收入为71百万美元,平均每处方净收入为209美元 [26] - 公司在2023年全年将运营费用(销售及一般管理费用加研发费用)减少了31%,约3800万美元 [26] - 公司在2023年12月31日的现金头寸为73.7百万美元 [27] 各条业务线数据和关键指标变化 - 2023年第四季度XHANCE新处方约26,500个,总处方约79,500个,均较2022年同期有所下降 [19] - 2023年全年XHANCE新处方约115,000个,总处方约339,000个,均较2022年全年略有下降 [20] - 公司通过有意识地减少不盈利处方,推动了平均每处方净收入的提升,2023年第四季度为250美元,较2022年同期增加11% [25] 各个市场数据和关键指标变化 - 公司目前有75个销售区域,已经针对慢性鼻窦炎机会进行了销售力量的优化调整 [39] 公司战略和发展方向及行业竞争 - 公司2023年的目标是提高运营效率,稳定XHANCE收入,同时为XHANCE获批治疗慢性鼻窦炎这一新适应症做准备 [10][11] - 如果XHANCE获批治疗慢性鼻窦炎,这将使公司可推广的患者群体至少扩大10倍,因为慢性鼻窦炎的诊断频率远高于鼻息肉 [14][15] - 新适应症的批准将使公司能够利用现有的商业能力,在耳鼻喉科和过敏专科领域建立一个盈利的业务 [13][35] - 新适应症的批准还将有助于公司与初级保健领域建立商业合作,以获取该领域的增量价值 [13][35] 管理层对经营环境和未来前景的评论 - 公司对2023年的经营目标和财务表现感到满意,为2024年XHANCE新适应症的潜在上市做好了准备 [10][11][34] - 公司对XHANCE获批治疗慢性鼻窦炎的前景感到兴奋,相信这将为公司带来重大的业务机遇 [33][34][53][54] - 公司正在与FDA就标签内容进行沟通,并对提交的临床试验数据充满信心 [41][42] - 公司对未来XHANCE在慢性鼻窦炎患者群体中的获得较广泛的医保准入持乐观态度 [49][50] 问答环节重要的提问和回答 问题1 **Thomas Flaten 提问** 请提供有关2023年1月销售队伍和分销优化的更多细节 [38] **Ramy Mahmoud 回答** 公司目前有75个销售区域,1月的调整是为了将销售力量更好地部署到慢性鼻窦炎机会上,而不是之前针对鼻息肉的部署 [39] 问题2 **David Amsellem 提问** 在现有商业基础上,公司预计能够覆盖慢性鼻窦炎患者群体的多大比例 [45] **Ramy Mahmoud 回答** 公司估计总的可获得患者群体约为1000-1200万,其中约三分之一在专科(耳鼻喉和过敏)领域,公司目前的75个销售区域已经针对这一机会进行了优化,预计能够覆盖这一专科领域的很大部分 [46][47]
OptiNose(OPTN) - 2023 Q4 - Annual Report
2024-03-07 20:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended December 31, 2023 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: 001-38241 OPTINOSE, INC. (Exact name of registrant as specified in its charter) Delaware 42-1771610 (State of other jur ...
OptiNose(OPTN) - 2023 Q4 - Annual Results
2024-03-07 20:00
Exhibit 99.1 Optinose Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Operational Highlights PDUFA target action date is March 16, 2024, for the Company's sNDA. If approved, the Company is prepared for launch of XHANCE for treatment of patients diagnosed with chronic sinusitis Physicians diagnose chronic sinusitis 10 times more frequently than XHANCE’s current nasal polyps indication and there is no FDA-approved medication for these patients Company reports fourth quarter and full yea ...
OptiNose(OPTN) - 2023 Q3 - Earnings Call Presentation
2023-11-09 23:04
Building a Leading ENT / Allergy Specialty Company C or porate P resentation N ove m be r 9, 2023 Forward-Looking Statements This presentation and our accompanying remarks contain “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. All statements that are not historical facts are hereby identified as forward-looking statements for this purpose and include, among others, statements relating to: the generation of XHANCE prescriptions and net revenues a ...
OptiNose(OPTN) - 2023 Q3 - Earnings Call Transcript
2023-11-09 23:04
分组1 - 公司认为未来批准XHANCE用于治疗慢性鼻窦炎的新适应症,可将可推广的患者群体增加至少10倍,因为医疗数据显示慢性鼻窦炎的诊断患者数量远高于鼻息肉患者 [11][16] - 公司认为鼻息肉的诊断也存在一定程度的低诊断,因为在没有鼻内镜检查能力的诊所很难观察到鼻腔内部的鼻息肉,这进一步增加了新适应症的潜在价值 [17] - 新适应症将为公司现有的商业团队创造强劲的增长机会,因为专科医生会看到大量的慢性鼻窦炎患者,同时也会扩展到公司目前触及不到的其他医生和患者群体,公司正在探索商业合作等方式来实现这一目标 [18][46] 分组2 - 公司2023年的目标是提高运营效率、稳定收入,同时为2024年XHANCE用于慢性鼻窦炎的潜在上市做好准备 [21][44] - 第三季度XHANCE处方量和总处方量略有下降,但处方医生数量有所增加,高处方医生数量有所下降,这反映了公司采取措施提高盈利能力的初步成效 [22][23][24][25][26][27] - 第三季度XHANCE平均净收入为每处方236美元,较去年同期增加6% [33][34] 问答环节重要的提问和回答 问题1 **Thomas Flaten 提问** 询问公司是否已经开始与FDA进行标签谈判 [49] **Ramy Mahmoud 回答** 公司距离FDA目标决定日还有37天,标签谈判预计会在本月内开始 [50] 问题2 **Thomas Flaten 提问** 询问公司调整共付额计划对第四季度收入的影响 [51] **Jonathan Neely 回答** 公司预计第四季度平均净收入将保持在200美元左右的水平,与全年预期一致 [52][53][56] 问题3 **Thomas Flaten 提问** 询问公司除了与初级护理合作外,还在探索哪些其他的推广方式 [57] **Ramy Mahmoud 回答** 公司正在探索一些新兴的推广方式,如利用直接面向消费者的营销和远程医疗等,而不仅仅依赖传统的直销模式 [58]