OptiNose(OPTN)

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OptiNose(OPTN) - 2021 Q1 - Quarterly Report
2021-05-05 11:02
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, 2021 ☐ 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) (State of other jurisdicti ...
OptiNose(OPTN) - 2020 Q4 - Earnings Call Transcript
2021-03-03 20:27
Financial Data and Key Metrics Changes - For the full year 2020, XHANCE net revenues increased by 59% to $48.4 million compared to 2019, with total prescriptions rising by 70% and new prescriptions by 31% [6][8] - Operating expenses for 2020 were $129 million, a 3% increase from 2019, reflecting disciplined expense management despite pandemic challenges [8][32] - Average net revenue per prescription for Q4 2020 was $211, while the full year average was $185, a decrease of 6% from 2019 [31][39] Business Line Data and Key Metrics Changes - New prescriptions for XHANCE reached 24,600 in Q4 2020, a 7% increase from Q3 2020 and a 16% increase from Q4 2019, marking the highest quarterly new prescriptions since launch [19][20] - Refill prescriptions increased to 49,300 in Q4 2020, comprising approximately two-thirds of the XHANCE business [21] - Total XHANCE prescriptions in Q4 2020 were approximately 73,900, representing a 36% growth over Q4 2019 [22] Market Data and Key Metrics Changes - XHANCE market share increased from 3.4% in Q4 2019 to 5.1% in Q4 2020, despite a declining overall market [25] - The breadth of physician prescribing grew, with approximately 6,700 physicians having patients fill at least one prescription of XHANCE, a 14% increase from Q4 2019 [27] Company Strategy and Development Direction - The company aims to drive revenue growth for XHANCE and complete clinical trials for chronic sinusitis, with expectations for improved business conditions in 2021 [61] - The partnership with Kaleo is expected to enhance market access and prescription growth as pandemic conditions improve [13][68] - The company is focused on expanding its target physician audience to approximately 18,000, including additional physicians reached through the Kaleo partnership [23][90] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism for 2021, anticipating a gradual return to pre-pandemic norms and increased patient volumes [66][69] - The company expects to achieve at least $80 million in net revenues for 2021, with potential upside driven by improved market conditions and recognition of XHANCE's role in treatment [34][67] Other Important Information - The company expects top-line data from at least one pivotal clinical trial for chronic sinusitis by the end of 2021, despite delays due to the pandemic [18][48] - OPN-019, a new product candidate, is being developed for potential use in COVID-19 prevention and treatment, with a pilot clinical trial expected to start in April 2021 [52][55] Q&A Session Summary Question: What gives confidence in achieving at least $80 million in revenue for 2021? - Management indicated that the $80 million floor reflects current market conditions and anticipated improvements in patient volumes and access to physician offices as the year progresses [66][67] Question: What is the enrollment status for the chronic sinusitis trials? - Management expects to complete enrollment around mid-year, with top-line data anticipated by year-end [71][72] Question: Where are share gains coming from in a declining category? - Share gains are attributed to increased usage from existing prescribers and the addition of new prescribers, with expectations for further growth as access improves [78][79] Question: What portion of prescriptions are currently off-label for chronic sinusitis? - Approximately one-third of prescriptions are specifically coded for nasal polyps, with some off-label use for chronic rhinosinusitis [80] Question: How is data quality being managed in clinical trials during the pandemic? - The company is implementing measures to ensure data quality and patient enrollment despite challenges posed by the pandemic [84]
OptiNose(OPTN) - 2020 Q4 - Annual Report
2021-03-03 12:07
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, 2020 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) (State of other jurisdiction of incorpo ...
OptiNose(OPTN) - 2020 Q3 - Earnings Call Transcript
2020-11-07 19:12
OptiNose, Inc. (NASDAQ:OPTN) Q3 2020 Results Conference Call November 5, 2020 8:00 AM ET Company Participants Jonathan Neely - Vice President, Investor Relations Peter Miller - Chief Executive Officer Ramy Mahmoud - President and Chief Operating Officer Vic Clavelli - Chief Commercial Officer Keith Goldan - Chief Financial Officer Conference Call Participants Stacy Ku - Cowen David Steinberg - Jefferies Brandon Folkes - Cantor Fitzgerald Rafay Sardar - BMO Operator Ladies and gentlemen, thank you for standi ...
OptiNose(OPTN) - 2020 Q3 - Earnings Call Presentation
2020-11-06 16:45
Q3 2020 Performance Highlights - XHANCE net revenue increased by 78% compared to Q3 2019[5, 24] - XHANCE TRx (total prescriptions) grew by 61% in Q3 2020 compared to Q3 2019[5, 12] - XHANCE net revenue per TRx was $224 in Q3 2020, an increase from $164 in Q2 2020[5, 24] - XHANCE achieved a 5.7% market share within the target physician audience in Q3 2020, a 2.7% increase compared to Q3 2019's 3.0% share[5, 16] - New prescriptions of XHANCE increased 23% in Q3 2020 compared to Q2 2020 and increased 29% in Q3 2020 compared to Q3 2019[9] Financial Position and Guidance - Cash and equivalents were $143 million as of September 30, 2020[6, 30, 32] - Full year 2020 operating expense guidance is lowered to between $127 million and $132 million, including approximately $10 million in stock-based compensation[5, 26] - The company qualified to draw $20 million from a debt facility due to Q3 2020 XHANCE net revenues exceeding $14.5 million and expects to draw it by early 2021[5, 26] Strategic Initiatives - Successful launch of kaléo co-promotion on October 1st[5, 30] - Physicians who had more than 15 XHANCE prescriptions filled by their patients in a quarter increased by 73% from Q3 2019 to Q3 2020 (1,153 versus 665)[19]
OptiNose(OPTN) - 2020 Q3 - Quarterly Report
2020-11-05 12:02
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 September 30, 2020 ☐ 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) (State of other jurisd ...
OptiNose(OPTN) - 2020 Q2 - Earnings Call Transcript
2020-08-06 20:12
Financial Data and Key Metrics Changes - OptiNose reported $10.3 million in net revenue for XHANCE in Q2 2020, with an average net revenue per prescription of $164, a nearly $40 increase from $126 in Q1 2020 [20][21] - Total prescriptions for XHANCE grew 84% year-over-year, with new prescriptions increasing by 20% compared to Q2 2019 [16][14] - The company maintained its financial guidance for operating expenses, expecting them to be between $131 million and $136 million for the full year 2020 [24] Business Line Data and Key Metrics Changes - XHANCE prescription volume continued to grow, with total prescriptions reaching approximately 62,500 in Q2 2020, reflecting an 84% growth over Q2 2019 [16][7] - New prescriptions for XHANCE were 18,700, a 20% increase compared to Q2 2019, while refill prescriptions surged to 43,800, a 139% increase year-over-year [14][15] - The number of physicians prescribing XHANCE increased by 40% year-over-year, with over 6,209 physicians having at least one patient fill a prescription [17] Market Data and Key Metrics Changes - XHANCE's market share increased from 2.2% in Q2 2019 to 5.6% in Q2 2020, marking the strongest share growth since its launch [12] - The company noted that despite COVID-19 disruptions, there remains significant headroom for additional growth in the XHANCE market [9] Company Strategy and Development Direction - The company announced a co-promotion partnership with kaleo to enhance promotional reach and frequency for XHANCE, targeting nearly 6,000 prescribers [8] - OptiNose is focused on growing XHANCE and building a leading ENT and allergy company, with plans to explore partnerships for future product development [68] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the resilience of XHANCE despite COVID-19 challenges, noting that patient visits to ENT and allergy practices began to improve as public health restrictions lifted [7][11] - The company expects to see continued growth in prescriptions as patient volumes recover, particularly in the late summer and fall [60] Other Important Information - The company has a strong balance sheet with $125 million in cash as of June 30, 2020, which is expected to fund operations until at least the second half of 2021 [9] - OptiNose is developing a new program, OPN019, aimed at delivering an antiseptic to combat COVID-19, leveraging its proprietary nasal Exhalation Delivery System [26][28] Q&A Session Summary Question: Can you help quantify the components of the delta in net revenue per prescription? - Management explained that the lower starting point in 2020 was influenced by annual insurance deductible resets and the impact of the ASSIST program, which provided free prescriptions to patients [32][33] Question: Can you provide some color on the economics of the kaleo partnership? - The partnership will involve kaleo calling on approximately 6,000 physicians, with half being new customers and the other half already in the OptiNose universe, enhancing frequency of contact [36][38] Question: Can you elaborate on the patient funnel seen in July? - Management noted that patient volumes are down between zero and 25% depending on geography, but the category appears to be normalizing, which could lead to a tailwind in the second half of the year [41][42] Question: What are the expectations for adding new patients given modest recovery for in-house visits? - Management indicated that new prescriptions are returning to pre-pandemic levels, with physicians creating safe environments for patients to return to offices [54] Question: What is the long-term strategy regarding reimbursement for XHANCE? - Management stated that they have good access with 75%-80% commercial access and do not plan to be more aggressive on rebates, believing the product brings real value to payers [72][73]
OptiNose(OPTN) - 2020 Q2 - Quarterly Report
2020-08-04 11:03
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 June 30, 2020 ☐ 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) - 2020 Q1 - Earnings Call Transcript
2020-05-10 20:30
OptiNose, Inc. (NASDAQ:OPTN) Q1 2020 Earnings Conference Call May 7, 2020 4:15 PM ET Company Participants Jonathan Neely - Vice President of Investor Relations Peter Miller - Chief Executive Officer Keith Goldan - Chief Financial Officer Vic Clavelli - Chief Commercial Officer Conference Call Participants Ken Cacciatore - Cowen & Company David Amsellem - Piper Sandler David Steinberg - Jefferies Operator Ladies and gentlemen, thank you for standing by and welcome to the OptiNose Q1 2020 Earnings Call. At th ...
OptiNose(OPTN) - 2020 Q1 - Earnings Call Presentation
2020-05-08 09:41
| --- | --- | --- | --- | |-------|-------------------|----------------------------------|-------| | | | | | | | Specialty Company | Building a Leading ENT / Allergy | | | | | Corporate Presentation | | | | | May 7, 2020 | | 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 statement ...