OptiNose(OPTN)

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OptiNose(OPTN) - 2021 Q4 - Earnings Call Transcript
2022-03-08 18:44
OptiNose, Inc. (NASDAQ:OPTN) Q4 2021 Earnings Conference Call March 8, 2022 8:00 AM ET Company Participants Jonathan Neely - Vice President, Investor Relations & Business Operations Peter Miller - Chief Executive Officer Ramy Mahmoud - President & Chief Operating Officer Victor Clavelli - Chief Commercial Officer Keith Goldan - Chief Financial Officer Conference Call Participants Brandon Folkes - Cantor Fitzgerald Dave Amsellem - Piper Sandler Gary Nachman - BMO Capital Markets Operator Good day, and thank ...
OptiNose(OPTN) - 2021 Q4 - Earnings Call Presentation
2022-03-08 18:29
Building a Leading ENT / Allergy Specialty Company Corporate Presentation March 8, 2022 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: potential for continued XHANCE prescription and net revenue growth and factors supporting such ...
OptiNose(OPTN) - 2021 Q4 - Annual Report
2022-03-08 13:29
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 For the transition period from ___________ to ______________. Commission file number: 001-38241 FORM 10-K OPTINOSE, INC. ☒ Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 (Exact name of registrant as specified in its charter) For the fiscal year ended December 31, 2021 Delaware 42-1771610 OR ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 (I.R.S. Employer Id ...
OptiNose(OPTN) - 2021 Q3 - Earnings Call Transcript
2021-11-16 19:41
OptiNose, Inc. (NASDAQ:OPTN) Q3 2021 Earnings Conference Call November 16, 2021 8:30 AM ET Company Participants Jonathan Neely - VP, IR & Business Operations Peter Miller - CEO & Director Keith Goldan - CFO Ramy Mahmoud - President & COO Conference Call Participants Gary Nachman - BMO Capital Markets David Amsellem - Piper Sandler David Steinberg - Jefferies Ken Cacciatore – Cowen Ladies and gentlemen, thank you for standing by, and welcome to the OptiNose Q3 2021 Earnings Call. At this time, all participan ...
OptiNose(OPTN) - 2021 Q3 - Quarterly Report
2021-11-15 21:34
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, 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) Delaware 42-1771610 (S ...
OptiNose(OPTN) - 2021 Q2 - Earnings Call Transcript
2021-08-11 19:24
OptiNose, Inc. (NASDAQ:OPTN) Q2 2021 Earnings Conference Call August 11, 2021 11:00 AM ET Company Participants Jonathan Neely - VP, IR & Business Operations Peter Miller - CEO & Director Keith Goldan - CFO Ramy Mahmoud - President & COO Conference Call Participants Brandon Folkes - Cantor Fitzgerald & Co. Steve Daddeo - RBC Capital Markets Kenneth Cacciatore - Cowen and Company David Amsellem - Piper Sandler & Co. Operator Good morning, ladies and gentlemen, and welcome to the OptiNose Second Quarter 2021 E ...
OptiNose(OPTN) - 2021 Q2 - Earnings Call Presentation
2021-08-11 16:01
Building a Leading ENT / Allergy Specialty Company Corporate Presentation August 11, 2021 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: potential for continued XHANCE prescription and net revenue growth and factors supporting su ...
OptiNose(OPTN) - 2021 Q2 - Quarterly Report
2021-08-11 11:05
[Forward-Looking Statements](index=4&type=section&id=NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section details forward-looking statements regarding XHANCE revenue, operating expenses, clinical trial timelines, and liquidity, protected by safe harbor provisions [Forward-Looking Statements](index=4&type=section&id=NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section details forward-looking statements regarding XHANCE revenue, operating expenses, clinical trial timelines, and liquidity, protected by safe harbor provisions - The company expects XHANCE net product revenues for the full year of 2021 to be at least **$80.0 million**[9](index=9&type=chunk) - Total GAAP operating expenses for 2021 are projected to be between **$137.0 million** and **$142.0 million**, including approximately **$10.0 million** in non-cash stock-based compensation[9](index=9&type=chunk) - Top-line results from the first of two Phase 3b chronic sinusitis clinical trials are expected in the first quarter of 2022, with the second trial's results anticipated in the second quarter of 2022[9](index=9&type=chunk) - Management believes existing cash and cash equivalents are sufficient to fund operations for at least the next twelve months from the filing date of this report[9](index=9&type=chunk) [PART I — FINANCIAL INFORMATION](index=7&type=section&id=PART%20I%20%E2%80%94%20FINANCIAL%20INFORMATION) [Financial Statements](index=7&type=section&id=Item%201.%20Financial%20Statements) This section presents OptiNose's unaudited interim consolidated financial statements for periods ended June 30, 2021 Consolidated Balance Sheet Highlights | Account | June 30, 2021 ($ thousands) | December 31, 2020 ($ thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $93,916 | $144,156 | | Total current assets | $132,594 | $180,652 | | Total assets | $139,515 | $188,813 | | Total current liabilities | $46,798 | $52,172 | | Long-term debt, net | $126,043 | $125,202 | | Total liabilities | $176,588 | $182,025 | | Total stockholders' equity (deficit) | $(37,073) | $6,788 | Consolidated Statement of Operations Highlights | Metric | Three Months Ended June 30, 2021 ($ thousands) | Three Months Ended June 30, 2020 ($ thousands) | Six Months Ended June 30, 2021 ($ thousands) | Six Months Ended June 30, 2020 ($ thousands) | | :--- | :--- | :--- | :--- | :--- | | Net product revenues | $18,357 | $10,272 | $29,317 | $17,334 | | Total revenues | $18,357 | $10,272 | $30,317 | $17,334 | | Total operating expenses | $37,912 | $32,871 | $72,062 | $66,219 | | Loss from operations | $(19,555) | $(22,599) | $(41,745) | $(48,885) | | Net loss | $(23,502) | $(25,852) | $(49,555) | $(54,708) | | Net loss per share | $(0.44) | $(0.56) | $(0.93) | $(1.19) | Consolidated Statement of Cash Flows Highlights | Cash Flow Activity | Six Months Ended June 30, 2021 ($ thousands) | Six Months Ended June 30, 2020 ($ thousands) | | :--- | :--- | :--- | | Cash used in operating activities | $(50,518) | $(51,518) | | Cash used in investing activities | $(10) | $(309) | | Cash provided by financing activities | $276 | $29,950 | | Net decrease in cash | $(50,252) | $(21,886) | [Notes to Unaudited Interim Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Unaudited%20Interim%20Consolidated%20Financial%20Statements) These notes provide detailed context for the financial statements, covering business operations, liquidity, accounting policies, and debt agreements - The company is a specialty pharmaceutical firm focused on ENT and allergy specialists, with its first commercial product being XHANCE®, approved for treating nasal polyps[31](index=31&type=chunk) - As of June 30, 2021, the company had cash and cash equivalents of **$93.9 million** and acknowledges it will likely require additional capital to meet future debt service obligations and fund operations[32](index=32&type=chunk)[33](index=33&type=chunk) - The company has a **$130 million** debt financing agreement (Pharmakon Senior Secured Notes) with funds managed by Pharmakon Advisors, LP, bearing interest at **10.75%** and maturing in September 2024, with covenants including a minimum cash balance of **$30 million**[65](index=65&type=chunk)[70](index=70&type=chunk)[73](index=73&type=chunk) - Subsequent to the quarter end, on August 11, 2021, the company entered into an Open Market Sale Agreement with Jefferies LLC to issue and sell up to **$50 million** of its common stock[91](index=91&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's analysis of financial condition, operations, COVID-19 impact, XHANCE performance, clinical development, and liquidity - The COVID-19 pandemic continues to adversely impact XHANCE prescription growth and net revenue, causing delays in clinical trial enrollment and pushing top-line results for chronic sinusitis trials to Q1 and Q2 2022[98](index=98&type=chunk)[102](index=102&type=chunk) XHANCE Performance Metrics (Q2 2021 vs. Q2 2020) | Metric | Q2 2021 | Q2 2020 | Growth | | :--- | :--- | :--- | :--- | | Total Prescriptions | 82,900 | 62,500 | 33% | | New Prescriptions | 29,000 | 18,700 | 55% | | Refill Prescriptions | 53,900 | 43,800 | 23% | | Average Net Revenue per Rx | $221 | $164 | 35% | - The company expects full-year 2021 XHANCE net product revenues to be at least **$80.0 million** and total GAAP operating expenses to be between **$137.0 million** and **$142.0 million**[129](index=129&type=chunk)[164](index=164&type=chunk) - As of June 30, 2021, the company had **$93.9 million** in cash and cash equivalents, which is believed sufficient to fund operations for at least the next twelve months, including maintaining the minimum cash balance required by its debt facility[151](index=151&type=chunk)[167](index=167&type=chunk) [Qualitative and Quantitative Disclosure About Market Risk](index=37&type=section&id=Item%203.%20Qualitative%20and%20Quantitative%20Disclosure%20About%20Market%20Risk) As a smaller reporting company, OptiNose is exempt from providing qualitative and quantitative disclosures about market risk - As a smaller reporting company, Optinose is not required to provide disclosures about market risk[173](index=173&type=chunk) [Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) The company's CEO and CFO concluded that disclosure controls were effective as of June 30, 2021, with no material changes to internal controls - The company's Chief Executive Officer and Chief Financial Officer concluded that disclosure controls and procedures were effective as of June 30, 2021[176](index=176&type=chunk) - There were no changes in internal control over financial reporting during the three months ended June 30, 2021, that materially affected, or are reasonably likely to materially affect, internal controls[177](index=177&type=chunk) [PART II — OTHER INFORMATION](index=38&type=section&id=PART%20II%20%E2%80%94%20OTHER%20INFORMATION) [Other Information](index=38&type=section&id=Item%205%20Other%20Information) This section discloses a post-period event where OptiNose entered an agreement to sell up to $50.0 million of common stock - On August 11, 2021, the Company entered into an Open Market Sale Agreement with Jefferies LLC, allowing it to issue and sell common stock for an aggregate sales price of up to **$50.0 million** through an "at the market" offering[179](index=179&type=chunk) - Jefferies will act as the sales agent and will receive a commission of up to **3.0%** of the gross proceeds from any shares sold under the agreement[180](index=180&type=chunk) [Exhibits](index=38&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including the Open Market Sale Agreement and CEO/CFO certifications - The list of exhibits includes the Open Market Sale Agreement dated August 11, 2021, between the Company and Jefferies LLC[186](index=186&type=chunk) - Certifications from the Chief Executive Officer and Chief Financial Officer pursuant to the Exchange Act are filed as exhibits 31.1, 31.2, 32.1, and 32.2[186](index=186&type=chunk)
OptiNose(OPTN) - 2021 Q1 - Earnings Call Presentation
2021-05-09 08:31
| --- | --- | --- | --- | |-------|-------------------|----------------------------------|-------| | | | | | | | Specialty Company | Building a Leading ENT / Allergy | | | | | Corporate Presentation | | | | | May 5, 2021 | | 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 ...
OptiNose(OPTN) - 2021 Q1 - Earnings Call Transcript
2021-05-09 07:30
OptiNose, Inc. (NASDAQ:OPTN) Q1 2021 Earnings Conference Call May 5, 2021 8:00 AM ET Company Participants Jonathan Neely - VP, IR & Business Operations Keith Goldan - Chief Financial Officer Peter Miller - Chief Executive Officer Ramy Mahmoud - President and Chief Operating Officer Victor Clavelli - Chief Commercial Officer Conference Call Participants Gary Nachman - BMO Capital Markets Georgi Yordanov - Cowen and Company Ed Chung - Jefferies Brandon Folkes - Cantor Fitzgerald Daniel Busby - RBC Capital Ma ...