optn-20220308
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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): March 8, 2022
__________________________________________________________________________________________

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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 March 8, 2022, OptiNose, Inc. (the “Company”) issued a press release announcing its financial results for the year ended December 31, 2021. 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 7, 2022, OptiNose, Inc. (the Company) issued a press release announcing top-line results from ReOpen1. ReOpen 1 was a randomized double-blinded, placebo controlled Phase 3 clinical trial examining the safety and efficacy of XHANCE® versus a placebo Exhalation Delivery System™ in adults with chronic sinusitis with or without nasal polyps. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

The Company will present top-line results from ReOpen1 during an investor call on March 7, 2022. 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
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)




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 7, 2022


Document
Exhibit 99.1
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Optinose Reports Fourth Quarter and Full Year 2021 Financial Results
and Recent Operational Highlights

Company reports fourth quarter and full year 2021 XHANCE net revenue of $22.5 million and $73.7 million

Full year 2021 XHANCE prescriptions increased 28% compared to full year 2020

Company expects XHANCE net revenue for 2022 to be at least $90 million

Company expects top-line results from the second of two clinical trials evaluating XHANCE as a potential treatment for Chronic Sinusitis in second quarter 2022

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

YARDLEY, Pa., March 8, 2022 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, 2021, and provided recent operational highlights.

"For the full year of 2021 versus 2020, XHANCE net revenues increased 52%, while total prescriptions and new prescriptions increased by 28% and 27%, respectively," stated CEO Peter Miller. "I believe these are outstanding results particularly in the context of a pandemic environment which has constrained both patient visits to physician offices and the ability of our territory managers to broadly meet in-person with our targeted physicians. Looking forward, I expect 2022 to be exciting time for our company as we continue to produce strong revenue growth with our current business, and we expect to complete our second clinical trial evaluating XHANCE for the treatment of chronic sinusitis. If successful, XHANCE has the potential to be the first ever drug treatment approved by the FDA for this indication which could be a game changer for both the 30 million patients suffering from symptoms of chronic sinusitis and for our company."
Fourth Quarter 2021 and Recent Highlights

Total and New XHANCE Prescriptions
The number of XHANCE® (fluticasone propionate) prescriptions increased by 27% from 73,900 in the fourth quarter 2020 to 93,700 in the fourth quarter 2021. In addition, XHANCE prescriptions increased by 28% from 261,400 for the full year of 2020 to 335,600 for the full year of 2021.

The number of new prescriptions for XHANCE increased by 21% from 24,600 in the fourth quarter of 2020 to 29,900 in the fourth quarter of 2021. In addition, new prescriptions for XHANCE increased by 27% from 88,600 for the full year of 2020 to 112,700 for the full year of 2021.

ReOpen1 Clinical Trial Top-line Results
In March 2022, the Company announced that the ReOpen1, a landmark clinical trial in chronic sinusitis, met both of its co-primary endpoints. A statistically significant improvement was demonstrated in patients with chronic sinusitis who were treated with the XHANCE Exhalation Delivery System in the ReOpen1 clinical trial compared to patients receiving an Exhalation Delivery System placebo as measured by both primary endpoints: first, a composite symptom score (comprising nasal congestion, facial pain or pressure, and nasal discharge) measured at week 4 and second, an objective measure of disease in the sinus cavities at week 24 (measured by average percent of the opacified volume on CT scan, summed across all of the ethmoid and maxillary sinuses).

The safety profile and tolerability of XHANCE in this trial were generally consistent with its currently labelled safety profile. Adverse events occurring at a rate of more than 3% with XHANCE and more common than the Exhalation Delivery System placebo were: epistaxis, nasopharyngitis, asthma, and cataract (nuclear and cortical).

Detailed results from this trial will be submitted for publication in a peer-reviewed journal and for presentation at future medical meetings




Fourth Quarter 2021 Financial Results

Revenue
The Company generated $22.5 million and $73.7 million of XHANCE net revenue during the three-month and twelve-month periods ended December 31, 2021, respectively. In addition, the Company generated $1.0 million of licensing revenue during the twelve-month period ended December 31, 2021. Total revenues for the three and twelve-month periods ended December 31, 2021 were $22.5 million and $74.7 million.

Expenses and net loss
For the three-month and twelve-month periods ended December 31, 2021, research and development expenses were $5.3 million and $25.3 million, respectively. Selling, general and administrative expenses were $26.3 million and $106.6 million during the three-month and twelve-month periods ended December 31, 2021, respectively. The net loss for the three-month period ended December 31, 2021 was $15.6 million, or $0.23 per share (basic and diluted). The net loss for the twelve-month period ended December 31, 2021 was $82.3 million, or $1.45 per share (basic and diluted).

Cash
The Company had cash and cash equivalents of $110.5 million as of December 31, 2021. In November 2021, The Company closed an underwritten public offering resulting in $42.8 million of net proceeds. The $42.8 million of cash is included in the Company's cash balance of $110.5 million as of December 31, 2021.

Corporate Guidance

XHANCE Net Revenue and Average Net Revenue per Prescription
The Company expects XHANCE net revenues for the full year of 2022 to be at least $90 million. This includes the Company's expectation that first quarter 2022 XHANCE net revenue will decrease compared to fourth quarter 2021. 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 2022 will decrease, 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 exceed $210 for full year 2022.

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 $135 to $140 million, of which the Company expects stock-based compensation to be approximately $10 million.

Chronic Sinusitis Clinical Trials
The Company expects top-line results from ReOpen2, the second its two clinical trials evaluating XHANCE as a potential treatment for chronic sinusitis, in the second quarter of 2022.

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 15, 2022 by dialing (855) 859-2056 from the U.S. or +1 (404) 537-3406 from outside the U.S. and entering conference ID: 8283756.

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 EndedYear Ended
December 31,December 31,
2021202020212020
Revenues:
Net product revenues$22,509 $15,597 $73,652 $48,367 
Licensing revenues— 750 1,000 750 
   Total revenues22,509 16,347 74,652 49,117 
Costs and expenses:
  Cost of product sales2,575 2,244 9,151 7,520 
  Research and development5,260 6,448 25,318 23,378 
  Selling, general and administrative26,342 28,107 106,633 105,438 
     Total costs and expenses34,177 36,799 141,102 136,336 
        Loss from operations(11,668)(20,452)(66,450)(87,219)
Other expense3,955 3,412 15,846 12,566 
Net loss$(15,623)$(23,864)$(82,296)$(99,785)
Net loss per share of common stock, basic and diluted$(0.23)$(0.46)$(1.45)$(2.07)
Weighted average common shares outstanding, basic and diluted67,831,835 43,467,985 56,851,921 48,275,230 
OptiNose, Inc.
Condensed Consolidated Balance Sheet Data
(in thousands)
December 31,December 31,
20212020
Cash and cash equivalents$110,502 $144,156 
Other assets55,569 44,657 
Total assets$166,071 $188,813 
Total current liabilities59,235 $52,172 
Long-term debt, net126,418 125,202 
Other liabilities2,190 4,651 
Total stockholders' equity(21,772)6,788 
Total liabilities and stockholders' equity$166,071 $188,813 


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 XHANCE prescription and net revenue growth; early year effects on price and volume related to patient insurance; the potential benefits of XHANCE for the treatment of chronic sinusitis, 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 the second of its two chronic sinusitis trials in the second quarter of 2022; the potential for XHANCE to be the first FDA-approved drug treatment for chronic sinusitis and, if approved for chronic sinusitis, the potential for such approval to be a game changer for both the 30 million patients suffering from chronic sinusitis and for the Company; projected average net revenue per prescription for first quarter and full year 2022; projected XHANCE net revenue for first quarter and full year 2022; projected Company GAAP operating expenses and stock-based compensation for 2022; 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 for its current and any potential future indication; the Company’s ability to maintain adequate third-party reimbursement for XHANCE (market access); the prevalence of chronic sinusitis and market opportunities for XHANCE may be smaller than expected; the Company’s ability to grow XHANCE prescriptions and net revenues; unanticipated costs and expenses; potential for varying interpretation of the top-line results from ReOpen1; potential for the full data set from ReOpen1, when available, to contain results that conflict with or are inconsistent with the top-line results; risks and uncertainties relating to the completion and results of ReOpen2; uncertainties related to the clinical development program and regulatory approval of XHANCE for the treatment of chronic sinusitis; 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.

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

###

a20220308q4earningsprese
Building a Leading ENT / Allergy Specialty Company C o r p o r a t e P r e s e n t a t i o n M a r c h 8 , 2 0 2 2 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; potential early year effects on price and volume related to patient insurance; projected Company GAAP operating expenses and stock-based compensation for 2022; projected XHANCE net revenues for first quarter and full year 2022; projected XHANCE average net revenue per prescription for first quarter and full year 2022; the potential benefits of XHANCE for the treatment of chronic sinusitis; the expectation of having top-line results from ReOpen2 in the second quarter of 2022; the Company's plans to seek approval for a follow-on indication for XHANCE for the treatment of chronic sinusitis, the potential for XHANCE to be the first FDA-approved drug treatment for chronic sinusitis and the potential market expansion opportunities and other benefits of obtaining such indication; the Company's plan to secure a partnership to promote XHANCE in primary care and the prospects for, and potential benefits of, such potential partnership; 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 for its current and any potential future indication; 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; the prevalence of chronic sinusitis and market opportunities for XHANCE may be smaller than expected; unexpected costs and expenses; potential for varying interpretation of the top-line results from ReOpen1 and the potential for the full data set, when available, to contain results that conflict with or are inconsistent with the top-line results; risks and uncertainties relating to the completion and results of ReOpen2; uncertainties related to the clinical development program and regulatory approval of XHANCE for the treatment of chronic sinusitis; the Company’s ability to comply with the covenants and other terms of the Pharmakon note purchase 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 2021 Highlights +27% XHANCE New Prescriptions Growth FY 2021/FY 2020 +52% XHANCE Net Revenue Growth FY 2021/FY 2020 $48.4 $73.7 2020 2021 ($M ) XHANCE Net Revenues $132M Full Year 2021 Operating Expenses (SG&A plus R&D) +28% XHANCE Prescriptions Growth FY 2021/FY 2020 +52%


 
4 Successful Development of XHANCE as the First FDA-approved Drug Treatment for Chronic Sinusitis Creates Multiple New Opportunities for Growth Up to approximately 1 Million patients with nasal polyps (NP) are treated by specialty physicians who are the current focus of our sales deployment 1 Million Up to approximately 10 Million patients with NP or CS are treated by a physician annually 10 Million Up to approximately 3 Million patients with either NP or CS are treated by specialty physicians who are the current focus of our sales deployment 3 million Today With a CS Indication For a Partner, there are 6 to 7 million NP+CS patients currently treated by a Primary Care Physician and 20 million lapsed patients that could be activated


 
5 Successful Development of XHANCE as a Treatment for Chronic Sinusitis Would Increase Opportunity and Address Certain Barriers to Broader Prescribing that Exist Today Insurance  Today, ~80% of commercial lives are in plans that cover XHANCE, but ~half require physicians to attest that they are prescribing for the approved indication  This is important because chronic sinusitis (CS) is diagnosed much more frequently than nasal polyps (NP)  ~10 million patients diagnosed with CS/NP are actively treated by physicians compared to ~1 million with NP


 
6 Objective evidence from large RCT of effect on inflammation deep inside the sinuses would be available for XHANCE for the first time Representative APOV Improvement in ReOpen1 in Patient Treated with XHANCE 186 µg BID 6.4% Improvement Week 24Baseline Images reflect individual results and results and may not be representative of results generally.


 
Q4 2021 Performance


 
8 Key Takeaways and Q4 2021 Highlights Consistent Commercial Execution Driving Q4 2021 Growth FY 2022 Revenue Guidance Implies Y/Y Growth of at least 22% Positive Top-Line Results from ReOpen1 Reported in 1Q2022 +44% XHANCE Net Revenue Growth Q4 2021/Q4 2020 $240 XHANCE Net Revenue per TRx in Q4 2021 $111M Cash and equivalents as of December 31, 2021 +27% XHANCE TRx Growth Q4 2021/Q4 2020 +21% XHANCE NRx Growth Q4 2021/Q4 2020 Top-Line Data from ReOpen2 Expected in Q2 2022


 
9 XHANCE New and Total Prescriptions XHANCE New Prescriptions increased 21% and Total Prescriptions increased 27% from Q4 2020 to Q4 2021 Estimated based on monthly prescription data from third parties and XHANCE preferred pharmacy network. The Market on this slide is defined as the sum of all intranasal steroid prescriptions based on monthly prescription data from third parties 24.6 29.9 Q4 '20 Q4 '21 XHANCE NRx (in thousands) +21% NRx for Intranasal Steroids Market increased 14% from Q4 2020 to Q4 2021 and TRx for Intranasal Steroids Market increased 6% from Q4 2020 to Q4 2021 73.9 93.7 0 30 60 90 120 Q4 '20 Q4 '21 XHANCE Prescriptions (in thousands) +27%


 
10 XHANCE Market Share & Prescribers by Prescribing Frequency 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. 5.1% 6.3% Q4 '20 Q4 '21 XHANCE Share of INS TRx Within Target Physician Audience 3,729 4,059 1,704 1,884 1,275 1,589 Q4 '20 Q4 '21 <5 TRx per Qtr 5 to 15 TRx per Qtr >15 TRx per Qtr XHANCE Prescribers 7,532 6,708 XHANCE market share increased from 5.1% to 6.3% and HCPs who had more than 15 XHANCE prescriptions filled by their patients in a quarter increased by 25% (1,589 versus 1,275) from Q4 2020 to Q4 2021


 
Q4 and Full Year 2021 Financial Update


 
12 $48.4 $73.7 FY 2020 FY 2021 Financial Review – XHANCE Net Revenue XHANCE Net Revenue Increased 44% from Q4 2020 to Q4 2021 and 52% for Full Year 2021 $15.6 $22.5 Q4 '20 Q4 '21 ($M) +44% Net Revenue Net Revenue +52% ($M)


 
13 $211 $240 Q4 '20 Q4 '21 Financial Review – XHANCE Average Net Revenue per Prescription XHANCE Average Net Revenue per TRx Increased from $211 to $240 from Q4 2020 to Q4 2021 and from $185 to $219 for Full Year 2021 $185 $219 FY 2020 FY 2021 +19% Average Net Revenue per TRx Average Net Revenue per TRx +14%


 
14 Full Year 2022 Financial Guidance  XHANCE Net Revenue ‒ Expected to be at least $90 million  XHANCE Average Net Revenue per Prescription ‒ FY 2022 expected to exceed $210 ‒ Q1 2022 expected  Operating Expense (GAAP) ‒ Expected to be between $135 – $140 million; approximately $10 million of which represents stock-based compensation


 
15 Additional Phase 3b Clinical Trial Data Expected in Q2 2022 Recruitment Completed July 2021 Recruitment Completed October 2021 Top-line results expected in Q1 2022 Top-line results expected in Q2 2022 


 
Closing Remarks


 
17 Key Takeaways and Q4 2021 Highlights Consistent Commercial Execution Driving Q4 2021 Growth FY 2022 Revenue Guidance Implies Y/Y Growth of at least 22% Positive Top-Line Results from ReOpen1 Reported in 1Q2022 +44% XHANCE Net Revenue Growth Q4 2021/Q4 2020 $240 XHANCE Net Revenue per TRx in Q4 2021 $111M Cash and equivalents as of December 31, 2021 +27% XHANCE TRx Growth Q4 2021/Q4 2020 +21% XHANCE NRx Growth Q4 2021/Q4 2020 Top-Line Data from ReOpen2 Expected in Q2 2022


 
18 Investor Relations – NASDAQ: OPTN Optinose Investor Contact Jonathan Neely, VP, Investor Relations and Business Development 267-521-0531 Investors@optinose.com At 31 December 2021: – $111 million in cash – Long-term debt: $130 million – 82.2 million common shares o/s – 12.4 million options, warrants & RSUs o/s 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 @optinose Analyst Coverage 1 BMO: Gary Nachman Cantor Fitzgerald: Brandon Folkes Cowen: Ken Cacciatore Jefferies: David Steinberg Piper Sandler: David Amsellem


 
Building a Leading ENT / Allergy Specialty Company C o r p o r a t e P r e s e n t a t i o n M a r c h 8 , 2 0 2 2