UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
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CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 3, 2021
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(Exact Name of Registrant as Specified in its Charter)
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| (State or Other Jurisdiction of Incorporation or Organization) | (Commission File No.) | (I.R.S. Employer Identification No.) | ||||||
(Address of principal executive offices and zip code)
(267 ) 364-3500
(Registrant’s telephone number, including area code)
(Former name or former address, if changed from last report)
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-14(c)) | |||||
| Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). | |||||
| Emerging growth company | |||||
| If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. | |||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading symbol(s) | Name of each exchange on which registered | ||||||||||||
Item 2.02 Results of Operations and Financial Condition.
On March 3, 2021, OptiNose, Inc. (the “Company”) issued a press release announcing its financial results for the year ended December 31, 2020. A copy of the press release is attached as Exhibit 99.1 to this report and is incorporated herein by reference.
* * *
The information included in Item 2.02 (including Exhibit 99.1) of this Form 8-K, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any Company filing under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 8.01 Other Events.
On March 3, 2021, the Company presented an updated Corporate Presentation during its financial results and corporate update call. A copy of the presentation is attached as Exhibit 99.2 to this report and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |||||||
| 99.1 | ||||||||
| 99.2 | ||||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.
| OptiNose, Inc. | ||||||||
| By: /s/ Keith A. Goldan | ||||||||
| Keith A. Goldan | ||||||||
| Chief Financial Officer | ||||||||
Date:March 3, 2021
Exhibit 99.1
Optinose Reports Fourth Quarter and Full Year 2020 Financial Results
and Recent Operational Highlights
Company reports fourth quarter and full year 2020 XHANCE net revenue of $15.6 million and $48.4 million
Full year 2020 XHANCE prescriptions increased 70% compared to full year 2019
Company expects XHANCE net revenue for 2021 to be at least $80 million
Company expects top-line results from one of its clinical trials evaluating XHANCE as a potential treatment for Chronic Sinusitis by the end of 2021
Conference call and webcast to be held today at 8:00 a.m. Eastern Time
YARDLEY, Pa., March 3, 2021 Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today reported financial results for the quarter and year ended December 31, 2020, and provided recent operational highlights.
"I am proud of how the team at Optinose responded to the market disruptions created by the global pandemic, enabling us to deliver 70% year-over-year growth of prescriptions for XHANCE," stated CEO Peter Miller. "As a launch-stage product, new patient starts are a critical driver of future success. Following pandemic-related disruption in second quarter, we achieved consecutive all-time highs for new prescriptions of XHANCE in third and fourth quarter 2020. Looking ahead, we believe we expect sustained or increased XHANCE growth in 2021. Our expectations for first quarter 2021 include typical early-year effects on price and volume related to patient insurance that we believe are common for chronic treatments that derive a significant proportion of total prescriptions from refills, and for full year 2021 we expect XHANCE net revenue to be at least $80 million."
Fourth Quarter 2020 and Recent Highlights
Total and New XHANCE Prescriptions
The number of XHANCE® (fluticasone propionate) prescriptions increased by 36% from 54,300 in the fourth quarter 2019 to 73,900 in the fourth quarter 2020. In addition, XHANCE prescriptions increased by 70% from 153,700 for the full year of 2019 to 261,400 for the full year of 2020.
The number of new prescriptions for XHANCE increased by 16% from 21,200 in the fourth quarter of 2019 to 24,600 in the fourth quarter of 2020. In addition, new prescriptions for XHANCE increased by 31% from 67,400 for the full year of 2019 to 88,600 for the full year of 2020.
OPN-019
In June 2020, the Company announced the initiation of development of a new product candidate, OPN-019, which combines its proprietary intranasal Exhalation Delivery System (EDS) with an antiseptic.
Because components of the drug-device combination product candidate, including both the active drug and delivery device, are currently commercially available in the U.S., the Company anticipates a potential streamlined and accelerated development. Subsequent to a pre-Investigational New Drug (IND) submission the Company is engaged with FDA regarding an IND and clinical development pathway.
The Company has performed in vitro testing against SARS-CoV-2 with a candidate formulation in which a 4-log reduction (a 99.99% reduction) in virus count was produced. In addition, the Company performed tests against other pathogens. For most pathogens tested, 3-log to 6-log reductions (99.9% to 99.9999% reductions) in virus count were observed.
In April 2021, the Company expects to initiate a randomized, proof of concept study in subjects who have tested positive for SARS-CoV-2 infection, are recently infected, and who have mild or no symptoms. This pilot study being conducted in Mexico will evaluate both the magnitude and duration of viral load reduction after a single dose of OPN-019. The Company expects top-line results from this study in second quarter 2021.
The Company is focused on supporting the initial stages of development within our current operating expense guidance and intend to seek grants, partnerships, and/or other sources of capital to fund future development.
Fourth Quarter 2020 Financial Results
Revenue
The Company generated $15.6 million and $48.4 million of XHANCE net revenue during the three-month and twelve-month periods ended December 31, 2020, respectively. In addition, the Company generated $0.8 million of licensing revenue during the three and twelve-month periods ended December 31, 2020. Total revenues for the three and twelve-month periods ended December 31, 2020 were $16.4 million and $49.2 million.
Expenses and net loss
For the three-month and twelve-month periods ended December 31, 2020, research and development expenses were $6.4 million and $23.4 million, respectively. Selling, general and administrative expenses were $28.1 million and $105.4 million during the three-month and twelve-month periods ended December 31, 2020, respectively. The net loss for the three-month period ended December 31, 2020 was $23.9 million, or $0.46 per share (basic and diluted). The net loss for the twelve-month period ended December 31, 2020 was $99.8 million, or $2.07 per share (basic and diluted).
Cash
The Company had cash and cash equivalents of $144.2 million as of December 31, 2020. In December 2020, the Company received $20 million of cash following the issuance of the Third Delayed Draw Notes under its existing Note Purchase Agreement with Pharmakon. The $20 million of cash is included in the Company's cash balance of $144.2 million as of December 31, 2020.
Corporate Guidance
XHANCE Net Revenue and Average Net Revenue per Prescription
The Company expects XHANCE net revenues for the full year of 2020 to be at least $80 million. This includes the Company's expectation that first quarter 2021 XHANCE net revenue will decrease compared to fourth quarter 2020. The primary driver of the sequential decrease to revenue is the Company's expectation that XHANCE average net revenue per prescription for the first quarter of 2021 will be between $120 and $140, due to typical early-year effects on price and volume related to patient insurance that the Company believes are common for chronic treatments that derive a significant proportion of total prescriptions from refills. The Company expects XHANCE average net revenue per prescription to improve substantially for the remainder of 2021. In addition, the Company expects full year 2021 XHANCE net revenue per prescription to increase compared to full year 2020 XHANCE net revenue per prescription of $185.
Operating Expenses
The Company expects total GAAP operating expenses (selling, general & administrative expenses and research & development expenses) for 2021 to be in the range of $137 - $142 million, of which the Company expects stock-based compensation to be approximately $11 million.
Chronic Sinusitis Clinical Trials
The Company expects top-line results from one of its clinical trials evaluating XHANCE as a potential treatment for Chronic Sinusitis by the end of 2021 and the other in the first half of 2022. Pauses in patient enrollment, due to the COVID-19 pandemic, at some clinical trial sites changed the Company's prior expectation of top-line results from both trials in the second half of 2021.
Company to Host Conference Call
Members of the Company’s leadership team will host a conference call and presentation to discuss financial results and corporate updates beginning at 8:00 a.m. Eastern Time today.
To participate on the conference call, please dial (866) 916-4761 from the U.S. or +1 (409) 216-6496 from outside the U.S. In addition, following the completion of the call, a telephone replay will be accessible until March 10, 2021 by dialing (855) 859-2056 from the U.S. or +1 (404) 537-3406 from outside the U.S. and entering conference ID: 9833299.
A simultaneous webcast of the call and presentation can be accessed by visiting the Investors section of Optinose’s website at www.optinose.com. In addition, a replay of the webcast will be available on the Company website for 60 days following the event.
| OptiNose, Inc. | |||||||||||||||||||||||
| Condensed Consolidated Statement of Operations | |||||||||||||||||||||||
| (in thousands, except share and per share data) | |||||||||||||||||||||||
| (Unaudited) | |||||||||||||||||||||||
| Three Months Ended | Year Ended | ||||||||||||||||||||||
| December 31, | December 31, | ||||||||||||||||||||||
| 2020 | 2019 | 2020 | 2019 | ||||||||||||||||||||
| Revenues: | |||||||||||||||||||||||
| Net product revenues | $ | 15,597 | $ | 11,081 | $ | 48,367 | $ | 30,401 | |||||||||||||||
| Licensing revenues | 750 | — | 750 | 4,230 | |||||||||||||||||||
| Total revenues | 16,347 | 11,081 | 49,117 | 34,631 | |||||||||||||||||||
| Costs and expenses: | |||||||||||||||||||||||
| Cost of product sales | 2,244 | 2,078 | 7,520 | 5,294 | |||||||||||||||||||
| Research and development | 6,448 | 5,379 | 23,378 | 20,783 | |||||||||||||||||||
| Selling, general and administrative | 28,107 | 26,545 | 105,438 | 104,155 | |||||||||||||||||||
| Total costs and expenses | 36,799 | 34,002 | 136,336 | 130,232 | |||||||||||||||||||
| Loss from operations | (20,452) | (22,921) | (87,219) | (95,601) | |||||||||||||||||||
| Other expense | 3,412 | 2,075 | 12,567 | 14,452 | |||||||||||||||||||
| Net loss | $ | (23,864) | $ | (24,996) | $ | (99,786) | $ | (110,053) | |||||||||||||||
| Net loss per share of common stock, basic and diluted | $ | (0.46) | $ | (0.58) | $ | (2.07) | $ | (2.63) | |||||||||||||||
| Weighted average common shares outstanding, basic and diluted | 52,327,655 | 43,467,985 | 48,275,230 | 41,877,527 | |||||||||||||||||||
| OptiNose, Inc. | ||||||||||||||
| Condensed Consolidated Balance Sheet Data | ||||||||||||||
| (in thousands) | ||||||||||||||
| December 31, | December 31, | |||||||||||||
| 2020 | 2019 | |||||||||||||
| Cash and cash equivalents | $ | 144,156 | $ | 147,144 | ||||||||||
| Other assets | 44,657 | 25,506 | ||||||||||||
| Total assets | $ | 188,813 | $ | 172,650 | ||||||||||
| Total current liabilities | 52,172 | $ | 36,139 | |||||||||||
| Long-term debt, net | 125,202 | 74,531 | ||||||||||||
| Other liabilities | 4,651 | 397 | ||||||||||||
| Total stockholders' equity | 6,788 | 61,583 | ||||||||||||
| Total liabilities and stockholders' equity | $ | 188,813 | $ | 172,650 | ||||||||||
About Optinose
Optinose is a specialty pharmaceutical company focused on serving the needs of patients cared for by ear, nose and throat (ENT) and allergy specialists. Optinose has offices in the U.S. and Norway. To learn more, please visit www.optinose.com or follow us on Twitter and LinkedIn.
Cautionary Note on Forward-Looking Statements
This press release contains 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 for continued or increased XHANCE prescription and net revenue growth and potential growth drivers; early year effects on price and volume related to patient insurance; the Company's plans to seek approval for a follow-on indication for XHANCE for the treatment of chronic sinusitis and the expectation of top line results from one of its chronic sinusitis trials by the end of 2021 and the other in the first half of 2022; projected average net revenue per prescription for first quarter and full year 2021; projected XHANCE net revenue for first quarter and full year 2021; projected Company GAAP operating expenses and stock-based compensation for 2021; development, timing of data, and funding plans for OPN-019 and the potential benefits of OPN-019; and other statements regarding the Company's future operations, financial performance, financial position, prospects, objectives and other future events. Forward-looking statements are based upon management’s current expectations and assumptions and are subject to a number of risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated by such forward-looking statements including, among others: impact of, and uncertainties caused by the COVID-19 pandemic; physician and patient acceptance of XHANCE; the Company’s ability to maintain adequate third-party reimbursement for XHANCE (market access); market opportunities for XHANCE may be smaller than expected; the Company’s ability to grow XHANCE prescriptions and net revenues; uncertainties and delays relating to the enrollment, completion, and results of clinical trials; unanticipated costs and expenses; our ability to comply with the covenants and other terms of the note purchase agreement entered into with funds managed by Pharmakon Advisors, LP; risks and uncertainties relating to intellectual property; and the risks, uncertainties and other factors discussed under the caption "Item 1A. Risk Factors" and elsewhere in the Company’s most recent Form 10-K and Form 10-Q filings with the Securities and Exchange Commission - which are available at www.sec.gov. As a result, you are cautioned not to place undue reliance on any forward-looking statements. Any forward-looking statements made in this press release speak only as of the date of this press release, and the Company undertakes no obligation to update such forward-looking statements, whether as a result of new information, future developments or otherwise.
Optinose Investor Contact
Jonathan Neely
jonathan.neely@optinose.com
267.521.0531
###
Building a Leading ENT / Allergy Specialty Company Corporate Presentat ion M a r c h 3 , 2 0 2 1 Exhibit 99.2
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: potential for continued XHANCE prescription and net revenue growth and factors supporting such growth; prescription, refill and market share trends; potential effects of INS market seasonality on XHANCE prescriptions; early year effects on net revenue and prescriptions related to patient insurance; projected Company GAAP operating expenses and stock-based compensation for 2021; projected XHANCE net revenues for full year and first quarter 2021; projected XHANCE net revenue per prescription for the first quarter and the remainder of 2021; the Company's plans to seek approval for a follow-on indication for XHANCE for the treatment of chronic sinusitis and the potential benefits of such indication; the expectation of top-line results from at least one chronic sinusitis trial by the end of 2021 and from the second trial in the first half of 2022; our development, timing of data, and funding plans for OPN-019 and the potential benefits of OPN-019; and other statements regarding the Company’s future operations, financial performance, prospects, intentions, objectives and other future events. Forward-looking statements are based upon management’s current expectations and assumptions and are subject to a number of risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated by such forward-looking statements including, among others: impact of, and the uncertainties caused by, the COVID- 19 pandemic; physician and patient acceptance of XHANCE; the Company’s ability to maintain adequate third party reimbursement for XHANCE (market access); the Company’s ability to grow XHANCE prescriptions and net revenues; market opportunities for XHANCE may be smaller than expected; uncertainties and delays relating to the initiation, enrollment, completion and results of clinical trials; unexpected costs and expenses; the Company’s ability to satisfy the conditions for an additional draw under the Pharmakon note purchase agreement and its ability to comply with the covenants and other terms of the agreement; risks and uncertainties relating to intellectual property; and the risks, uncertainties and other factors discussed in the “Risk Factors” section and elsewhere in our most recent Form 10-K and Form 10-Q filings with the Securities and Exchange Commission – which are available at http://www.sec.gov. As a result, you are cautioned not to place undue reliance on any forward-looking statements. Any forward-looking statements made in this presentation speak only as of the date of this presentation, and we undertake no obligation to update such forward-looking statements, whether as a result of new information, future developments or otherwise.
3 Full Year 2020 Highlights +31% XHANCE New Prescriptions Growth FY 2020/FY 2019 +59% XHANCE Net Revenue Growth FY 2020/FY 2019 $30.4 $48.4 2019 2020 ($M ) XHANCE Net Revenue $129M Full Year 2020 Operating Expenses (SG&A plus R&D) +70% XHANCE Prescriptions Growth FY 2020/FY 2019 +59%
4 Key Takeaways and Q4 2020 Highlights Largest Number of XHANCE New Prescriptions Since Launch Full Year 2020 Performance Aligned with Company Guidance Providing Initial Company Guidance for Q1 and Full Year 2021 Multiple factors support increased revenue growth in 2021 Topline data from one CS trial expected by the end of 2021 +41% XHANCE Net Revenue Growth Q4 2020/Q4 2019 $211 XHANCE Net Revenue per TRx in Q4 2020 $144M Cash and equivalents as of December 31, 2020 +36% XHANCE TRx Growth Q4 2020/Q4 2019 +16% XHANCE NRx Growth Q4 2020/Q4 2019
XHANCE Launch Update
6 New prescriptions of XHANCE increased 7% in Q4 2020 compared to Q3 2020 and increased 16% in Q4 2020 compared to Q4 2019 Estimated based on monthly prescription data from public source and XHANCE preferred pharmacy network. Q4 2020 XHANCE New Prescriptions 23.0 24.6 0 10 20 30 Q3 '20 Q4 '20 XHANCE NRx (in thousands) +7% 21.2 24.6 0 10 20 30 Q4 '19 Q4 '20 XHANCE NRx (in thousands) +16% NRx for Intranasal Steroids Market increased 5% from Q3 2020 to Q4 2020, and decreased 21% from Q4 2019 to Q4 2020
7 Prescriptions of XHANCE increased 36% in Q4 2020 compared to Q4 2019 Estimated based on monthly prescription data from public source and XHANCE preferred pharmacy network. 21.2 22.3 18.7 23.0 24.6 33.0 33.7 43.8 46.1 49.3 0 20 40 60 80 Q4 '19 Q1 '20 Q2 '20 Q3 '20 Q4 '20 New Prescriptions Refills XHANCE Prescription Trends XHANCE Prescriptions (in thousands) 62.5 54.3 56.1 +36% 69.0 73.9 TRx for Intranasal Steroids Market increased 2% from Q3 2020 to Q4 2020, and decreased 13% from Q4 2019 to Q4 2020
8 0.0% 1.0% 2.0% 3.0% 4.0% 5.0% 6.0% Q4 ‘20Q4 ‘19 Q3 ‘20Q1 ‘20 Q2 ‘20 XHANCE Share of INS Prescriptions Within the Target Physician Audience Increased in Q4 2020 and a Large Opportunity Remains New for 2021 - we increased the size of our target physician audience from ~10,000 to ~18,000 to include all ENT and Allergy physicians who prescribe INS and to reflect expanded in-person reach following the launch of the kaléo co-promotion XHANCE Share of INS TRx Within Target Physician Audience The Market on this slide is defined as the sum of all intranasal steroid prescriptions written by physicians in the XHANCE target physician audience of approximately 18,000 physicians. Estimated based on monthly prescription data from third parties and XHANCE preferred pharmacy network. 3.4% 3.4% 4.4% 4.9% 5.1%
9 Physicians who had more than 15 XHANCE prescriptions filled by their patients in a quarter increased by 54% from Q4 2019 to Q4 2020 (1,275 versus 828) Estimated based on monthly prescription data from third parties and XHANCE preferred pharmacy network. 3,432 3,944 3,631 3,677 3,729 1,599 1,506 1,550 1,613 1,704 828 895 1,028 1,153 1,275 - 2,000 4,000 6,000 8,000 Q4 '19 Q1 '20 Q2 '20 Q3 '20 Q4 '20 <5 TRx per Quarter 5 to 15 TRx per Quarter >15 TRx per Quarter Number of XHANCE Prescribers by Prescribing Frequency XHANCE Prescribers 6,443 5,859 6,345 6,209 6,708
Q4 2020 Financial Update
11 Financial Review – Fourth Quarter 2020 Q4 2020 XHANCE Net Revenue Increased 41% Compared to Q4 2020 XHANCE Average Net Revenue per TRx $211 in Q4 2020 – $204 in Q4 2019 $185 for full year 2020 ‒ $198 for full year 2019 $11.1 $15.6 Q4 '19 Q4 '20 ($M ) XHANCE Net Revenue +41%
12 FY 2020 Operating Expenses $104.2 $105.4 $20.8 $23.4 2019 2020 SG&A and R&D Expenses (GAAP) SG&A R&D ($M) FY 2020 R&D increased 12% compared to FY 2019 Driven by the conduct of our CS clinical trials FY 2020 SG&A increased 1% compared to FY 2019 Increased volume related expenses offset by expense reductions in response to the COVID-19 pandemic FY 2020 Operating Expenses (SG&A plus R&D) increased 3% compared to FY 2019 +3%
13 First Quarter and Full Year 2021 Financial Guidance XHANCE Net Revenue ‒ FY 2021 expected to be at least $80 million ‒ 1Q 2021 expected to decrease compared to Q4 2020 similar to the pattern of calendar effect on XHANCE net revenue reported last year • Q1 2021 XHANCE net revenue per prescription is expected to be between $120 - $140 ‒ XHANCE net revenue per prescription expected to improve substantially for the remainder of 2021 • Full year 2021 XHANCE Net Revenue per Prescription expected to increase compared to full year 2020 Operating Expense (GAAP) expected to be between $137 – $142 million ‒ Approximately $11 million of which represents stock-based compensation
Chronic Sinusitis Trials
15 Chronic Sinusitis (CS) is a Large Market for XHANCE that Includes Opportunities for Potential Partners Source: Palmer J et al . A cross-sectional population-based survey of the prevalence, disease burden, and characteristics of the US adult population with symptoms of chronic rhinosinusitis (CRS). Poster session presented at: 62nd Annual Meeting of the American Rhinologic Society; September 16-17, 2016; San Diego, CA. Optinose Market Research. Data on file. Our commercialization of XHANCE is currently focused on ENT and Allergy specialists who treat ~3.5 million CRS patients which includes ~1.2 million patients who have nasal polyps Successful development of XHANCE as the first FDA approved treatment for chronic sinusitis could support our commercial efforts and also create opportunities outside ENT and Allergy to more fully address the needs of ~30 million US adults who have CRS 30 Million US Adults suffer from CRS, ~20 million without nasal polyps (NP) 3.5 Million CRS patients treated by ENT/Allergy specialists 1.2 Million NP patients treated by ENT/Allergy specialists 9.75 Million CRS patients seek physician care annually
16 XHANCE Chronic Sinusitis Indication (sNDA) The Chronic Sinusitis clinical research program includes two Phase 3b clinical trials Both trials are 24-week randomized, double-blind, placebo-controlled, parallel-group, multicenter studies Both trials have co-primary endpoints: 1) a measure of patient-reported symptom relief and 2) a measure of effect inside the sinus cavities Week 4 Change from baseline to week 4/endpoint in symptoms as measured by a composite symptom score (congestion, facial pain/pressure, nasal discharge) Week 24 Change from baseline to week 24/endpoint in average percent opacification of maxillary and ethmoid sinuses as measured by CT Randomization Top-line results are expected from one trial by the end of 2021 1:1:1 to placebo, 186 μg, or 372 μg OPN-375 twice daily (BID)
17 OPN-019 Pilot Study Human in vivo data will supplement in vitro data Prior in vitro testing against SARS-CoV-2 with a candidate formulation produced a 4-log reduction in virus count Randomized, adaptive proof of concept single-dose study to evaluate change in viral load after OPN-019 in adults with COVID-19 Assessments will include reduction in viral load by qRT-PCR and in number of infectious viral particles by culture Up to three cohorts of 10 patients are planned Top line results expected within second quarter 2021 We intend to support initial stages of development for OPN-019 within current operating expense guidance Grants, partnerships, and/or other sources of capital will be necessary to fund future development
Closing Remarks
19 Key Takeaways and Q4 2020 Highlights Largest Number of XHANCE New Prescriptions Since Launch Full Year 2020 Performance Aligned with Company Guidance Providing Initial Company Guidance for Q1 and Full Year 2021 Multiple factors support increased revenue growth in 2021 Topline data from one CS trial expected by the end of 2021 +41% XHANCE Net Revenue Growth Q4 2020/Q4 2019 $211 XHANCE Net Revenue per TRx in Q4 2020 $144M Cash and equivalents as of December 31, 2020 +36% XHANCE TRx Growth Q4 2020/Q4 2019 +16% XHANCE NRx Growth Q4 2020/Q4 2019
20 Investor Relations – NASDAQ: OPTN Optinose Investor Contact Jonathan Neely, VP, Investor Relations and Business Operations 267-521-0531 1 - Optinose is followed by the analysts listed above. Please note that any opinions, estimates or forecasts regarding the Company’s performance made by these analysts are theirs alone and do not represent opinions, forecasts or predictions of Optinose or its management. Optinose does not by its reference above or distribution imply its endorsement of or concurrence with such information, conclusions or recommendations. investors@optinose.com www.optinose.com At 31 December 2020: – $144 million in cash – Long-term debt: $130 million – 52.9 million common shares o/s – 9.2 million options, warrants & RSUs o/s @optinose Analyst Coverage 1 BMO: Gary Nachman Cantor Fitzgerald: Brandon Folkes Cowen: Ken Cacciatore Jefferies: David Steinberg Piper Sandler: David Amsellem RBC: Randall Stanicky
Building a Leading ENT / Allergy Specialty Company Corporate Presentat ion M a r c h 3 , 2 0 2 1