UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
____________________________________________________________________________________________
FORM 8-K
____________________________________________________________________________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 4, 2020
__________________________________________________________________________________________
OPTINOSE, INC.
(Exact Name of Registrant as Specified in its Charter)
____________________________________________________________________________________________
| Delaware | 001-38241 | 42-1771610 | ||||||
| (State or Other Jurisdiction of Incorporation or Organization) | (Commission File No.) | (I.R.S. Employer Identification No.) | ||||||
1020 Stony Hill Road, Suite 300
Yardley, Pennsylvania 19067
(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)
____________________________________________________________________________________________
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 | ||||||||||||
| Common stock, par value $0.001 per share | OPTN | Nasdaq Global Select Market | ||||||||||||
Item 2.02 Results of Operations and Financial Condition.
On August 4, 2020, OptiNose, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 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 August 4, 2020, 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: August 4, 2020
Exhibit 99.1
Optinose Reports Second Quarter 2020 Financial Results
and Recent Operational Highlights
Company reports second quarter 2020 XHANCE net revenue of $10.3 million
Second quarter 2020 XHANCE prescriptions increased 84% from second quarter 2019
Conference call and webcast to be held today at 8:00 a.m. Eastern Time
YARDLEY, Pa., August 4, 2020 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 ended June 30, 2020, and provided operational updates.
“XHANCE prescription volume continued to grow in the second quarter, which was impressive given the major disruptions to patient volumes and care pathways within ENT and allergy physician practices,” stated CEO Peter Miller. “XHANCE had exceptionally strong market share growth, demonstrating remarkable resilience, as we successfully adapted our business to the COVID-19 environment. We are excited by the potential for XHANCE to continue to grow and recently announced a co-promotion with kaléo that will amplify our effort. We look forward to a strong partnership that we believe can have meaningful impact.”
Second Quarter 2020 and Recent Highlights
XHANCE Prescriptions
The number of XHANCE® (fluticasone propionate) prescriptions increased by 84% from second quarter 2019 to second quarter 2020.
Kaléo Co-Promotion Agreement
In July the Company announced the signing of an agreement with kaléo, a pharmaceutical company dedicated to building innovative solutions for serious and life-threatening medical conditions, to co-promote XHANCE. Under the terms of the agreement, kaléo will promote XHANCE to an agreed-upon audience of office-based healthcare professionals, which is expected to increase promotional reach and frequency starting by the fourth quarter of 2020. The audience includes nearly 6,000 prescribers about half of whom are outside of the current Optinose called-on universe of approximately 10,000 healthcare professionals.
OPN-019
In June the Company announced the initiation of development of a new product candidate, OPN-019. OPN-019 will combine the Company’s proprietary nasal Exhalation Delivery System (EDS) technology with an antiseptic that has been recently shown in third party in vitro studies to kill the virus that causes COVID-19. 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 expects to be able to rapidly progress to a meeting with FDA to discuss an IND and then onward to clinical trials. The Company is focused on supporting the initial stages of development within its current operating expense plan and intends to seek grants, partnerships, and/or other sources of capital to fund future development.
Peer-Reviewed Scientific Journal Publications
Pooled analysis of the Company's NAVIGATE I and II phase 3 clinical trials highlighting improvement in quality of life and health status measures were published in the International Forum of Allergy & Rhinology1.
In addition, results from VIZUALIZE, a study using nasal endoscopy video to evaluate the efficacy and safety of XHANCE twice daily in adults with bilateral nasal polyps were published in Rhinology2, the official journal of the International Rhinologic Society.
Second Quarter 2020 Financial Results
Net product revenues
The Company generated $10.3 million and $17.3 million in net product revenues from sales of XHANCE during the three and six months ended June 30, 2020, respectively.
Costs and expenses and net loss
For the three and six months ended June 30, 2020, research and development expenses were $5.5 million and $10.4 million, respectively and selling, general and administrative expenses were $25.7 million and $52.8 million, respectively. The net loss for the three and six months ended June 30, 2020 was $25.9 million, or $0.56 per share (basic and diluted) and $54.7 million, or $1.19 per share (basic and diluted), respectively.
Cash
The Company had cash and cash equivalents of $125.3 million as of June 30, 2020.
Corporate Guidance
XHANCE Net Revenue per Prescription
The Company expects XHANCE average net revenue per prescription to improve through the remainder of 2020.
Operating Expenses
The Company expects total GAAP operating expenses (selling, general & administrative expenses and research & development expenses) for 2020 to be in the range of $131 - $136 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 both of its clinical trials evaluating XHANCE as a potential treatment for Chronic Sinusitis 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 August 11, 2020 by dialing (855) 859-2056 from the U.S. or +1 (404) 537-3406 from outside the U.S. and entering conference ID #
2298719. 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 | Six Months Ended | ||||||||||||||||||||||
| June 30, | June 30, | ||||||||||||||||||||||
| 2020 | 2019 | 2020 | 2019 | ||||||||||||||||||||
| Revenues: | |||||||||||||||||||||||
| Net product revenues | $ | 10,272 | $ | 6,677 | $ | 17,334 | $ | 10,653 | |||||||||||||||
| Licensing revenues | — | — | — | 500 | |||||||||||||||||||
| Total revenues | 10,272 | 6,677 | 17,334 | 11,153 | |||||||||||||||||||
| Costs and expenses: | |||||||||||||||||||||||
| Cost of product sales | 1,700 | 1,089 | 3,056 | 1,827 | |||||||||||||||||||
| Research and development | 5,474 | 5,295 | 10,406 | 9,857 | |||||||||||||||||||
| Selling, general and administrative | 25,697 | 26,000 | 52,757 | 52,340 | |||||||||||||||||||
| Total costs and expenses | 32,871 | 32,384 | 66,219 | 64,024 | |||||||||||||||||||
| Loss from operations | (22,599) | (25,707) | (48,885) | (52,871) | |||||||||||||||||||
| Other expense | 3,253 | 1,670 | 5,823 | 3,380 | |||||||||||||||||||
| Net loss | $ | (25,852) | $ | (27,377) | $ | (54,708) | $ | (56,251) | |||||||||||||||
| Net loss per share of common stock, basic and diluted | $ | (0.56) | $ | (0.66) | $ | (1.19) | $ | (1.36) | |||||||||||||||
| Weighted average common shares outstanding, basic and diluted | 45,908,104 | 41,310,068 | 45,907,133 | 41,283,478 | |||||||||||||||||||
| OptiNose, Inc. | ||||||||||||||
| Condensed Consolidated Balance Sheet Data | ||||||||||||||
| (in thousands) | ||||||||||||||
| June 30, | December 31, | |||||||||||||
| 2020 | 2019 | |||||||||||||
| (unaudited) | ||||||||||||||
| Cash and cash equivalents | $ | 125,266 | $ | 147,144 | ||||||||||
| Other assets | 27,782 | 25,506 | ||||||||||||
| Total assets | $ | 153,048 | $ | 172,650 | ||||||||||
| Total current liabilities | $ | 34,898 | $ | 36,139 | ||||||||||
| Long-term debt, net | 104,947 | 74,531 | ||||||||||||
| Other liabilities | 594 | 397 | ||||||||||||
| Total stockholders' equity | 12,609 | 61,583 | ||||||||||||
| Total liabilities and stockholders' equity | $ | 153,048 | $ | 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., the U.K. 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 impact of, our plans regarding and the uncertainty caused by the COVID-19 pandemic; the potential for continued XHANCE growth; the expected commencement of promotional activities by kaléo by the fourth quarter of 2020 and the potential benefits of those activities; the Company’s development plans and objectives for OPN-019, the potential benefits of OPN-019 and the Company’s intention to fund initial development of OPN-019 within its current operating expense plan and to seek grants, partnerships and/or other sources of capital to fund future development; 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 both of its chronic sinusitis trials in second half 2021; expectation that XHANCE average net revenue per prescription will improve through the remainder of 2020; projected Company GAAP operating expenses and stock-based compensation for 2020; 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: the extent and duration of the COVID-19 pandemic and its impact on the Company’s business, results of operations and financial condition; 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 effectiveness of kaléo’s sales representatives in promoting XHANCE; risks, uncertainties and delays relating to product development, the initiation, enrollment, completion and results of clinical trials and the regulatory approval process; risks that results seen in preclinical studies may not be replicated in humans; intense competition for vaccines and other therapies for COVID-19; the Company’s ability to grow XHANCE prescriptions and net revenues; unanticipated costs and expenses; the Company's 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.
References
1 - Soler ZM, Colman S, Velez FF, Schlosser RJ,Exhalation delivery system with fluticasone improves quality of life and health status: pooled analysis of phase 3 trials NAVIGATE I and II, International Forum of Allergy & Rhinology, DOI: 10.1002/alr.22573.
2 - Yao WC, Ramakrishnan VR, Luong AU, Citardi MJ, VISUALIZE: a 24-week, open-label study using nasal endoscopy video to evaluate the efficacy and safety of EDS-FLU 186 μg twice daily in adults with bilateral nasal polyps, Rhinology online, 3, Vol 3: 58-66.
Optinose Investor Contact
Jonathan Neely
jonathan.neely@optinose.com
267.521.0531
###
Exhibit 99.2 Building a Leading ENT / Allergy Specialty Company Corporate Presentation August 4, 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 statements for this purpose and include, among others, statements relating to: impact of, our plans regarding and the uncertainties caused by, the COVID-19 pandemic; potential for continued XHANCE growth, potential growth drivers and market opportunity; prescription, refill, prescribing frequency and market share trends; potential effects of INS market seasonality on XHANCE prescriptions; projected operating expenses and stock-based compensation for 2020; expectation that XHANCE net revenue per prescription will improve for the remainder of 2020; the Company's plans to seek, and the potential benefits of, a follow-on indication for XHANCE for chronic sinusitis (CS); the expectation of top line results from both CS trials in second half 2021; the expectation that existing cash plus funds that may be available under the Pharmakon note purchase agreement will be sufficient to fund operations until top line data from at least one CS trial; the commencement and potential benefits of promotional activities by kaleo; the Company’s development plans and objectives for OPN-019, the potential benefits of OPN-019 and the Company’s intention to fund initial development of OPN-019 within its current operating expense plan and to seek grants, partnerships and/or other sources of capital to fund future development; 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: the extent and duration of the impact of the COVID-19 pandemic on the Company’s business, results of operations and financial condition; 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, net revenues, market share and prescriber breadth and depth; market opportunities for XHANCE may be smaller than expected; the effectiveness of kaleo’s sales representatives in promoting XHANCE; uncertainties and delays relating to product development, the initiation, enrollment, completion and results of clinical trials and regulatory approval process; unexpected costs and expenses; the ability to satisfy the conditions for additional funds under the Pharmakon note purchase agreement and 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 2 update such forward-looking statements, whether as a result of new information, future developments or otherwise.
Key Takeaways and Q2 2020 Highlights Resilient XHANCE Performance in COVID-19 Environment New Kaléo Co-Promotion to Strengthen Commercial Efforts Substantial Headroom for Future XHANCE Growth Maintaining Financial Guidance and Clinical Trial Timing Strong Balance Sheet and Prudent Expense Management 5.6% +84% $125M Q2 2020 market share XHANCE TRx Cash and equivalents an increase of 1.8% Growth Q2 2020 / as of June 30, 2020 compared to Q1 2020 +54% Q2 2019 $164 XHANCE Net XHANCE Net Revenue Growth Revenue per TRx Q2 2020/Q2 2019 in Q2 2020 3
XHANCE Launch Update
XHANCE Share of INS Prescriptions Within the Target Physician Audience Increased Dramatically in Q2 2020 and a Large Opportunity Remains Market share within the XHANCE target physician audience of 5.6% in Q2 2020 an increase of more than 2.5 times compared to Q2 2019 share of 2.2% XHANCE Share of INS TRx Within Target Physician Audience 5.6% 6.0% 5.0% 3.8% 4.0% 3.5% 3.0% 3.0% 2.2% 2.0% 1.0% 0.0% Q2 ‘19 Q3 ‘19 Q4 ‘19 Q1 ‘20 Q2 ‘20 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 10,000 physicians. Estimated based on monthly prescription data from public source and XHANCE preferred pharmacy network. 5
Q2 2020 XHANCE New and Refill Prescriptions New prescriptions of XHANCE increased Refill prescriptions of XHANCE increased 139% in Q2 20% in Q2 2020 compared to Q2 2019 2020 compared to Q2 2019 XHANCE NRx (in thousands) XHANCE Refills (in thousands) +139% 50 30 +20% 43.8 40 20 18.7 30 15.6 20 18.4 10 10 0 - Q2 '19 Q2 '20 Q2 '19 Q2 '20 6 Estimated based on monthly prescription data from public source and XHANCE preferred pharmacy network.
XHANCE Prescription Trends Prescriptions of XHANCE increased 84% in Q2 2020 compared to Q2 2019 XHANCE Prescriptions (in thousands) 80 +84% 62.5 60 54.3 56.1 43.0 40 43.8 33.9 33.0 33.7 25.2 18.4 20 21.2 22.3 15.6 17.8 18.7 0 Q2 '19 Q3 '19 Q4 '19 Q1 '20 Q2 '20 New Prescriptions Refills TRx for Intranasal Steroids Market decreased 12% from Q2 2019 to Q2 2020, and decreased 16% from Q1 2020 to Q2 2020 NRx for Intranasal Steroids Market decreased 25% from Q2 2019 to Q2 2020, and decreased 30% from Q1 2020 to Q2 2020 7 Estimated based on monthly prescription data from public source and XHANCE preferred pharmacy network.
Number of XHANCE Prescribers by Prescribing Frequency Physicians who had more than 15 XHANCE prescriptions filled by their patients in a quarter increased by 97% from Q2 2019 to Q2 2020 (1,028 versus 523) XHANCE Prescribers 7,000 6,345 6,209 5,859 6,000 895 1,028 5,075 828 5,000 4,442 665 1,506 1,599 1,550 4,000 523 1,379 1,139 3,000 2,000 3,944 3,432 3,631 2,780 3,031 1,000 - Q2 '19 Q3 '19 Q4 '19 Q1 '20 Q2 '20 <5 TRx per Quarter 5 to 15 TRx per Quarter >15 TRx per Quarter Estimated based on monthly prescription data from public source and XHANCE preferred pharmacy network. 8
Q2 2020 Financial Update
Financial Review – Second Quarter 2020 Q2 2020 XHANCE Net Revenue Increased 54% Compared to Q2 2019 ($M ) XHANCE Net Revenue +54% XHANCE Average Net Revenue per TRx $10.3 . $164 in Q2 2020 $6.7 • Increase compared to $126 in Q1 2020 Q2 '19 Q2 '20 10
Corporate Guidance . XHANCE Average Net Revenue per TRx . XHANCE Average Net Revenue per Prescription expected to improve for the remainder of 2020 . Operating Expense (GAAP) expected to be between $131 – $136 million . Approximately $11 million of which represents stock-based compensation . Chronic Sinusitis Clinical Trials . Expect top-line results from both trials evaluating XHANCE as a potential treatment for Chronic Sinusitis in the second half of 2021 11
Closing Remarks
Key Takeaways and Q2 2020 Highlights Resilient XHANCE Performance in COVID-19 Environment New Kaléo Co-Promotion to Strengthen Commercial Efforts Substantial Headroom for Future XHANCE Growth Maintaining Financial Guidance and Clinical Trial Timing Strong Balance Sheet and Prudent Expense Management 5.6% +84% $125M Q2 2020 market share XHANCE TRx Cash and equivalents an increase of 1.8% Growth Q2 2020 / as of June 30, 2020 compared to Q1 2020 +54% Q2 2019 $164 XHANCE Net XHANCE Net Revenue Growth Revenue per TRx Q2 2020/Q2 2019 in Q2 2020 13
Investor Relations – NASDAQ: OPTN At 30 June 2020: Analyst Coverage 1 – $125 million in cash – Long-term debt: $110 million BMO: Gary Nachman – 45.9 million common shares o/s – 12.3 million options, RSUs & warrants o/s Cantor Fitzgerald: Brandon Folkes Cowen: Ken Cacciatore Optinose Investor Contact Jefferies: David Steinberg Jonathan Neely, VP, Investor Relations and Business Operations 267-521-0531 Piper Sandler: David Amsellem RBC: Randall Stanicky investors@optinose.com www.optinose.com @optinose 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. 14
Building a Leading ENT / Allergy Specialty Company Corporate Presentation August 4, 2020