optn-20201105
0001494650false00014946502020-11-052020-11-05

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): November 5, 2020
__________________________________________________________________________________________

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OPTINOSE, INC.
(Exact Name of Registrant as Specified in its Charter)
____________________________________________________________________________________________
Delaware001-3824142-1771610
(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 classTrading symbol(s)Name of each exchange on which registered
Common stock, par value $0.001 per shareOPTNNasdaq Global Select Market




Item 2.02 Results of Operations and Financial Condition.

On November 5, 2020, OptiNose, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 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 November 5, 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: November 5, 2020


Document
Exhibit 99.1
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Optinose Reports Third Quarter 2020 Financial Results
and Recent Operational Highlights

Company reports third quarter 2020 XHANCE net revenue of $15.4 million

New prescriptions of XHANCE increased 23% from second quarter 2020

Conference call and webcast to be held today at 8:00 a.m. Eastern Time

YARDLEY, Pa., Nov. 5, 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 three and nine months ended September 30, 2020, and provided operational updates.

“New and total prescriptions for XHANCE reached an all-time quarterly high in the third quarter of 2020. We are pleased with this achievement after experiencing a challenging environment in the second quarter 2020 due to significant pandemic-related declines in patient volume in ENT and Allergy offices,” stated CEO Peter Miller. “As a result of increased demand and improvement in net revenue per prescription, XHANCE net revenues were $15.4 million. By exceeding the third quarter 2020 net revenue threshold specified in our debt facility, we open up the option to draw an additional $20 million to add to our cash position, which would extend our cash runway and further enable us to focus on growth. Finally, we are excited by recent events that we believe meaningfully support XHANCE growth potential as we progress into 2021. These include both our co-promotion with kaléo, which first hit the field in October and grows our sales reach and frequency, and the new publication by Brent Senior, M.D., Professor of Otolaryngology and Vice Chair of Academics and Outreach at the University of North Carolina, and others that describes the value of XHANCE in the population of patients who are still symptomatic on conventional nasal steroids.”

Third Quarter 2020 and Recent Highlights

Total and New XHANCE Prescriptions
The number of XHANCE® (fluticasone propionate) prescriptions increased by 61% from 43,000 in the third quarter of 2019 to 69,000 in the third quarter of 2020.

The number of new prescriptions for XHANCE increased by 23% from 18,700 in the second quarter of 2020 to 23,000 in the third quarter of 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 initiated promotion of XHANCE to an agreed-upon audience of office-based healthcare professionals on October 1st. 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.

Peer-Reviewed Scientific Journal Publications
In September the Company announced the publication of a peer-reviewed paper titled, “Efficacy of the exhalation delivery system with fluticasone (EDS-FLU) in patients who remain symptomatic on standard nasal steroid sprays”1 in the International Forum of Allergy & Rhinology, the journal of the American Rhinologic Society. EDS-FLU is U.S. Food and Drug Administration (FDA) approved for the treatment of nasal polyps in patients 18 years of age or older and is marketed under the trade name XHANCE for the up to 1 in 3 patients whose chronic rhinosinusitis is complicated by nasal polyps.







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) with an antiseptic that has been shown in third party in vitro studies to kill the virus that causes COVID-19.

The Company has performed in vitro testing against SARS-CoV-2 with a candidate antiseptic formulation in which a 4-log reduction (a 99.99% reduction) in virus count was produced. In addition, the Company is performing tests against other pathogens and expects results in November.

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 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 is focused on supporting the initial stages of development within its current operating expense guidance and intends to seek grants, partnerships, and/or other sources of capital to fund future development.

Third Quarter 2020 Financial Results

Net product revenues
The Company generated $15.4 million and $32.8 million in net product revenues from sales of XHANCE during the three and nine months ended September 30, 2020, respectively.

Costs and expenses and net loss
For the three and nine months ended September 30, 2020, research and development expenses were $6.5 million and $16.9 million, respectively and selling, general and administrative expenses were $24.6 million and $77.3 million, respectively. The net loss for the three and nine months ended September 30, 2020 was $21.2 million, or $0.43 per share (basic and diluted) and $75.9 million, or $1.62 per share (basic and diluted), respectively.

Cash and cash equivalents
The Company had cash and cash equivalents of $143.1 million as of September 30, 2020.

Corporate Guidance

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 $127 - $132 million, of which the Company expects stock-based compensation to be approximately $10 million. Previously the Company expected 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 stock-based compensation was expected 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.

Cash and cash equivalents
The Company expects to draw $20 million of cash from its debt facility by early 2021, subject to continuing to meet eligibility requirements.

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 November 12,



2020 by dialing (855) 859-2056 from the U.S. or +1 (404) 537-3406 from outside the U.S. and entering conference ID #4167801. 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.

Investor Conferences

Chief Executive Officer Peter Miller will present at the Jefferies Virtual London Healthcare Conference on November 18, 2020, at 9:05 a.m. ET. Additionally, Mr. Miller will present at the 32nd Annual Piper Sandler Healthcare Conference on November 23, 2020, at 10:00 a.m. ET.

A live webcast will be available for each conference in the Investors section of the Optinose website. A replay will be available for 60 days following the conclusion of each event.


OptiNose, Inc.
Condensed Consolidated Statement of Operations
(in thousands, except share and per share data)
(Unaudited)
Three Months EndedNine Months Ended
September 30,September 30,
2020201920202019
Revenues:
Net product revenues$15,436 $8,667 $32,770 $19,320 
Licensing revenues— 3,730 — 4,230 
   Total revenues15,436 12,397 32,770 23,550 
Costs and expenses:
  Cost of product sales2,221 1,389 5,276 3,216 
  Research and development6,524 5,547 16,930 15,404 
  Selling, general and administrative24,575 25,270 77,332 77,610 
     Total costs and expenses33,320 32,206 99,538 96,230 
        Loss from operations(17,884)(19,809)(66,768)(72,680)
Other expense3,330 8,999 9,154 12,378 
Net loss$(21,214)$(28,808)$(75,922)$(85,058)
Net loss per share of common stock, basic and diluted$(0.43)$(0.69)$(1.62)$(2.06)
Weighted average common shares outstanding, basic and diluted48,907,514 41,454,181 46,914,561 41,341,570 




OptiNose, Inc.
Condensed Consolidated Balance Sheet Data
(in thousands)
September 30,December 31,
20202019
(unaudited)
Cash and cash equivalents$143,134 $147,144 
Other assets37,890 25,506 
Total assets$181,024 $172,650 
Total current liabilities$43,350 $36,139 
Long-term debt, net105,013 74,531 
Other liabilities4,978 397 
Total stockholders' equity27,683 61,583 
Total liabilities and stockholders' equity$181,024 $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 impact of, our plans regarding and the uncertainty caused by the COVID-19 pandemic; the potential for continued XHANCE growth; the potential benefits of kaléo promotional activities; the potential benefits of the publication of the peer-reviewed paper titled, “Efficacy of the exhalation delivery system with fluticasone (EDS-FLU) in patients who remain symptomatic on standard nasal steroid sprays” in the International Forum of Allergy & Rhinology; the potential benefits of our OPN-019 product candidate; our expectation to have additional OPN-019 in vitro testing data in November 2020; our development and funding plans and expectations for OPN-019; our expectation that we will draw an additional $20.0 million under the Pharmakon Note Purchase Agreement before February 15, 2021, subject to continuing to meet the eligibility requirements at the time of the draw; our 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 our chronic sinusitis trials in second half 2021; 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 meet the continued eligibility requirements to draw the additional $20 million under the Pharmakon Note Purchase Agreement and otherwise comply with the covenants and other terms of the note purchase agreement; 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 - Senior BA, Schlosser RJ, Bosso J, Soler ZM. Efficacy of the exhalation delivery system with fluticasone in patients who remain symptomatic on standard nasal steroid sprays. Int Forum Allergy Rhinol. 2020 Sept 24. doi: 10.1002/alr.22693. [Epub ahead of print]

Optinose Investor Contact
Jonathan Neely
jonathan.neely@optinose.com
267.521.0531

###

q320earningspresentation
Exhibit 99.1 Building a Leading ENT / Allergy Specialty Company Corporate Presentation November 5, 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; 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 to draw additional $20M from debt facility by early 2021; the potential benefits of promotional activities by kaléo; 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 kaléo’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 update such forward- looking statements, whether as a result of new information, future developments or otherwise. 2


 
Key Takeaways and Q3 2020 Highlights Largest Number of XHANCE New Prescriptions Since Launch Successful Launch of kaléo Co-Promotion on October 1st Lowering Full Year 2020 Operating Expense Guidance Substantial Headroom for Future XHANCE Growth XHANCE Revenue Exceeded Threshold for $20 Million Draw +78% $224 $143M XHANCE Net Revenue XHANCE Net Revenue Cash and equivalents Growth per TRx as of Q3 2020/Q3 2019 in Q3 2020 September 30, 2020 +61% 5.7% XHANCE TRx Q3 2020 market share Growth Q3 2020 / Q3 an increase of 2.7% 2019 compared to Q3 2019 3


 
XHANCE Launch Update


 
Q3 2020 XHANCE New Prescriptions New prescriptions of XHANCE increased 23% in Q3 2020 compared to Q2 2020 and increased 29% in Q3 2020 compared to Q3 2019 XHANCE NRx (in thousands) XHANCE NRx (in thousands) 30 +23% 30 +29% 23.0 23.0 18.7 20 20 17.8 10 10 0 0 Q2 '20 Q3 '20 Q3 '19 Q3 '20 NRx for Intranasal Steroids Market decreased 5% from Q2 2020 to Q3 2020, and decreased 12% from Q3 2019 to Q3 2020 5 Estimated based on monthly prescription data from public source and XHANCE preferred pharmacy network.


 
XHANCE Prescription Trends Prescriptions of XHANCE increased 61% in Q3 2020 compared to Q3 2019 XHANCE Prescriptions (in thousands) +61% 80 69.0 62.5 60 54.3 56.1 43.0 46.1 40 43.8 33.0 33.7 25.2 20 23.0 17.8 21.2 22.3 18.7 0 Q3 '19 Q4 '19 Q1 '20 Q2 '20 Q3 '20 New Prescriptions Refills TRx for Intranasal Steroids Market decreased 6% from Q2 2020 to Q3 2020, and decreased 7% from Q3 2019 to Q3 2020 6 Estimated based on monthly prescription data from public source and XHANCE preferred pharmacy network.


 
XHANCE Share of INS Prescriptions Within the Target Physician Audience Increased in Q3 2020 and a Large Opportunity Remains Market share within the XHANCE target physician audience of 5.7% in Q3 2020 an increase of 2.7% compared to 3.0% share in Q3 2019 XHANCE Share of INS TRx Within Target Physician Audience 7.0% 6.0% 5.6% 5.7% 5.0% 3.8% 4.0% 3.5% 3.0% 3.0% 2.0% 1.0% 0.0% Q3 ‘19 Q4 ‘19 Q1 ‘20 Q2 ‘20 Q3 ‘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. 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 73% from Q3 2019 to Q3 2020 (1,153 versus 665) XHANCE Prescribers 7,000 6,443 6,345 6,209 5,859 6,000 895 1,028 1,153 5,075 828 5,000 665 1,506 1,613 1,599 1,550 4,000 1,379 3,000 2,000 3,944 3,432 3,631 3,677 3,031 1,000 - Q3 '19 Q4 '19 Q1 '20 Q2 '20 Q3 '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


 
Q3 2020 Financial Update


 
Financial Review – Third Quarter 2020 Q3 2020 XHANCE Net Revenue Increased 78% Compared to Q3 2019 ($M ) XHANCE Net Revenue XHANCE Average Net +78% Revenue per TRx $15.4 . $224 in third quarter 2020 • Increase compared to $164 in Q2 2020 $8.7 . $175 for the nine months ended September 30, 2020 Q3 '19 Q3 '20 10


 
Updated Corporate Guidance . Operating Expense (GAAP) . Expected to be between $127 – $132 million; approximately $10 million of which represents stock-based compensation . Prior guidance range of $131 - $136 million; approximately $11 million of which was 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 . Cash and Cash Equivalents . Company qualified to draw $20 million of cash from debt facility as a result of Q3 2020 XHANCE net revenues > $14.5M . Company expects to draw the $20 million by early 2021 (subject to meeting continued eligibility requirements) . A final $20 million from the debt facility is available subject to achieving XHANCE net revenues of at least $26.0 million in Q2 2021 11


 
Closing Remarks


 
Key Takeaways and Q3 2020 Highlights Largest Number of XHANCE New Prescriptions Since Launch Successful Launch of kaléo Co-Promotion on October 1st Lowering Full Year 2020 Operating Expense Guidance Substantial Headroom for Future XHANCE Growth XHANCE Revenue Exceeded Threshold for $20 Million Draw +78% $224 $143M XHANCE Net Revenue XHANCE Net Revenue Cash and equivalents Growth per TRx as of Q3 2020/Q3 2019 in Q3 2020 September 30, 2020 +61% 5.7% XHANCE TRx Q3 2020 market share Growth Q3 2020 / Q3 an increase of 2.7% 2019 compared to Q3 2019 13


 
Investor Relations – NASDAQ: OPTN At 30 September 2020: Analyst Coverage 1 – $143 million in cash – Long-term debt: $110 million BMO: Gary Nachman – 52.1 million common shares o/s Cantor Fitzgerald: Brandon Folkes At 5 November 2020: – 10.5 million options, RSUs & warrants o/s 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 November 5, 2020