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8-K - FORM 8-K - ICAD INCd620505d8k.htm

Exhibit 99.1

 

LOGO

iCAD REPORTS THIRD QUARTER FINANCIAL RESULTS

Year-to-Date Total Revenue Growth of 17%; Therapy Revenue Growth of 41% Driven by Significant Adoption of the Xoft System for the Treatment of Non-Melanoma Skin Cancer

Conference Call Begins Tuesday, October 29th at 10:00 a.m. Eastern Time

NASHUA, N.H. (October 28, 2013) – iCAD, Inc. (Nasdaq: ICAD), an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, today reported financial results for the three and nine months ended September 30, 2013.

“iCAD delivered another quarter of strong operating performance. Third quarter revenue of $8.3 million was the highest since we began executing on our broadened oncology strategy more than two years ago. We also demonstrated improvements in both the Cancer Detection and Therapy businesses, and continued to achieve positive adjusted EBITDA,” said Ken Ferry, President and CEO of iCAD.

“Our Therapy business performed well as evidenced by significant increases in year-to-date revenue, product placements and utilization. Market adoption has been particularly strong for the treatment of non-melanoma skin cancer. Positive three-year data using the Xoft System to treat skin cancer that was reported at ASTRO showed effective long-term treatment with no recurrences and excellent cosmetic outcomes. We are confident that with ongoing positive clinical data combined with growing favorable reimbursement, we remain well positioned to continue strong growth in the Therapy business.

“For the third quarter, revenue at our Cancer Detection business grew 14% over the prior year, with double-digit growth in both product and service and supply revenue. We believe our service business growth of 18% clearly demonstrates success with our strategy to increase recurring revenue. Finally, we are seeing considerable traction from PowerLook, our next-generation mammography CAD platform, from both new customers and upgrades from our growing installed base.

“We are very pleased with our performance to date in 2013 across both of our businesses. We remain steadfast in our goal to drive revenue growth in the Therapy and Cancer Detection businesses through appropriate investments combined with disciplined financial management,” concluded Mr. Ferry.


Third Quarter Financial Results

Revenue: Total revenue for the third quarter of 2013 increased to $8.3 million from $8.2 million for the third quarter of 2012, due to an increase in Cancer Detection revenue partially offset by a decline in Therapy revenue.

Cancer Detection revenue included film, digital mammography, MRI and CT CAD platforms, as well as service and supply revenue from these products. Therapy revenue included Xoft® Axxent® Electronic Brachytherapy System® product sales, as well as the associated service and supply revenue.

 

     Three months ended September 30,  
     2013      2012      % Change  

Detection revenue

        

Product revenue

   $ 2,246       $ 2,023         11.0

Service revenue

     2,064         1,757         17.5
  

 

 

    

 

 

    

 

 

 

Total Revenue

   $ 4,310       $ 3,780         14.0
  

 

 

    

 

 

    

 

 

 

Therapy revenue

        

Product revenue

   $ 2,519       $ 3,638         (30.8 )% 

Service revenue

     1,461         765         91.0
  

 

 

    

 

 

    

 

 

 

Total Revenue

   $ 3,980       $ 4,403         (9.6 )% 
  

 

 

    

 

 

    

 

 

 

Gross Margin: Gross profit for the third quarter of 2013 increased to $5.9 million, or 71.5% of revenue, from $5.8 million, or 71.9% of revenue, for the third quarter of 2012, primarily due to product mix, partially offset by the impact of the Medical Device Excise Tax, which went into effect in 2013.

Operating Expenses: Total operating expenses for the quarter ended September 30, 2013 declined to $6.3 million from $6.6 million for the same period in 2012, as a result of ongoing cost-control measures, partially offset by commercial and R&D investments.

Non-GAAP Adjusted EBITDA: Non-GAAP adjusted EBITDA, a non-GAAP financial measure as defined below, was $545,000 for the third quarter of 2013, compared with non-GAAP adjusted EBITDA of $240,000 for the same period in 2012.

Net Loss: The net loss for the third quarter of 2013 was $589,000, or $0.05 per share, compared with a net loss for the third quarter of 2012 of $1.5 million, or $0.14 per share.

 

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Non-GAAP Adjusted Net Loss: The non-GAAP adjusted net loss, as defined below, for the third quarter of 2013 was $1.2 million, or $0.11 per share, compared with a non-GAAP adjusted net loss for the third quarter of 2012 of $1.6 million, or $0.15 per share.

Cash and Cash Flow: As of September 30, 2013, iCAD had cash and cash equivalents of $10.2 million, compared with $12.9 million as of June 30, 2013 and $13.9 million as of December 31, 2012. Net cash used by operations for the first nine months of 2013 was $3.2 million.

Nine Month Financial Results

Revenue: Total revenue for the first nine months of 2013 increased 17.0% to $24.0 million from $20.5 million for the first nine months of 2012, including a 41.4% increase in Therapy revenue and a 1.6% increase in Cancer Detection revenue.

 

     Nine months ended September 30,  
     2013      2012      % Change  

Detection revenue

        

Product revenue

   $ 6,566       $ 7,327         (10.4 )% 

Service revenue

     6,189         5,225         18.4
  

 

 

    

 

 

    

 

 

 

Total Revenue

   $ 12,755       $ 12,552         1.6
  

 

 

    

 

 

    

 

 

 

Therapy revenue

        

Product revenue

   $ 7,763       $ 5,921         31.1

Service revenue

     3,414         1,984         72.1
  

 

 

    

 

 

    

 

 

 

Total Revenue

   $ 11,177       $ 7,905         41.4
  

 

 

    

 

 

    

 

 

 

Gross Margin: Gross profit for the first nine months of 2013 was $16.8 million, or 70.2% of revenue, compared with gross profit for the first nine months of 2012 of $14.5 million, or 70.8% of revenue.

Operating Expenses: Total operating expenses for the nine months ended September 30, 2013 declined to $18.0 million from $19.1 million for the same period in 2012.

Non-GAAP Adjusted EBITDA: Non-GAAP adjusted EBITDA for the first nine months of 2013 was $1.6 million, compared with a non-GAAP adjusted EBITDA loss of $1.6 million for the first nine months of 2012.

 

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Net Loss: The net loss for the first nine months of 2013 was $3.2 million, or $0.30 per share, compared with a net loss for the first nine months of 2012 of $6.7 million, or $0.62 per share.

Non-GAAP Adjusted Net Loss: The non-GAAP adjusted net loss for the first nine months of 2013 was $3.7 million, or $0.34 per share, compared with a non-GAAP adjusted net loss for the first nine months of 2012 of $7.1 million, or $0.66 per share.

Use of Non-GAAP Financial Measures

In its quarterly news releases, conference calls, slide presentations or webcasts, the Company may use or discuss non-GAAP financial measures as defined by SEC Regulation G. The GAAP financial measures most directly comparable to each non-GAAP financial measure used or discussed, and a reconciliation of the differences between each non-GAAP financial measure and the comparable GAAP financial measure, are included in this press release after the condensed consolidated financial statements. When analyzing the Company’s operating performance, investors should not consider these non-GAAP measures as a substitute for the comparable financial measures prepared in accordance with GAAP. The Company’s quarterly news releases containing such non-GAAP reconciliations can be found on the Investors section of the Company’s website at www.icadmed.com.

Conference Call

iCAD management will host an investment community conference call on Tuesday, October 29, 2013 beginning at 10:00 a.m. Eastern time to discuss these results and answer questions. Shareholders and other interested parties may participate in the conference call by dialing 888-680-0865 (domestic) or 617-213-4853 (international) and entering passcode 48869679. The call also will be broadcast live on the Internet at www.streetevents.com, www.earnings.com and www.icadmed.com.

A replay of the conference call will be accessible two hours after its completion through November 4, 2013 by dialing 888-286-8010 (domestic) or 617-801-6888 (international) and entering passcode 44988318. The call will also be archived for 90 days at www.streetevents.com, www.earnings.com and www.icadmed.com.

About iCAD, Inc.

iCAD is an industry-leading provider of advanced image analysis, workflow solutions and radiation therapies for the early identification and treatment of common cancers. iCAD’s Xoft System offers radiation treatment for early-stage breast cancer that can be administered in the form of intraoperative radiation therapy or accelerated partial breast irradiation. The Xoft System is also cleared for the treatment of non-melanoma skin cancer and endometrial cancer. iCAD offers a comprehensive range of high-performance, upgradeable CAD solutions for mammography and advanced image analysis and workflow solutions for Magnetic Resonance Imaging, for breast and prostate cancers and Computed Tomography for colorectal cancer. For more information, call 877-iCADnow, or visit www.icadmed.com.

 

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For iCAD, contact Kevin Burns at 937-431-7967 or via email at kburns@icadmed.com

For iCAD investor relations, contact Anne Marie Fields of LHA at 212-838-3777 x6604 or via email at afields@lhai.com

For iCAD media inquiries, contact Helen Shik of Schwartz MSL at 781-684-0770 or via email at iCAD@schwartzmsl.com

“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995

Certain statements contained in this News Release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve a number of known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, but are not limited to the Company’s ability to defend itself in litigation matters, to achieve business and strategic objectives, the risks of uncertainty of patent protection, the impact of supply and manufacturing constraints or difficulties, uncertainty of future sales levels, protection of patents and other proprietary rights, the impact of supply and manufacturing constraints or difficulties, product market acceptance, possible technological obsolescence of products, increased competition, litigation and/or government regulation, changes in Medicare or other reimbursement policies, risks relating to our existing and future debt obligations, competitive factors, the effects of a decline in the economy or markets served by the Company; and other risks detailed in the Company’s filings with the Securities and Exchange Commission. The words “believe”, “demonstrate”, “intend”, “expect”, “estimate”, “will”, “continue”, “anticipate”, “likely”, “seek”, and similar expressions identify forward-looking statements. Readers are cautioned not to place undue reliance on those forward-looking statements, which speak only as of the date the statement was made. The Company is under no obligation to provide any updates to any information contained in this release. For additional disclosure regarding these and other risks faced by iCAD, please see the disclosure contained in our public filings with the Securities and Exchange Commission, available on the Investors section of our website at http://www.icadmed.com and on the SEC’s website at http://www.sec.gov.

-Tables to Follow -

 

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iCAD, INC. AND SUBSIDIARY

Condensed Consolidated Balance Sheets

(Unaudited)

(In thousands except for share data)

 

     September 30,     December 31,  
     2013     2012  
Assets     

Current assets:

    

Cash and cash equivalents

   $ 10,209      $ 13,948   

Trade accounts receivable, net of allowance for doubtful accounts of $73 in 2013 and $48 in 2012

     8,419        4,980   

Inventory, net

     2,003        2,119   

Prepaid expenses and other current assets

     658        486   
  

 

 

   

 

 

 

Total current assets

     21,289        21,533   
  

 

 

   

 

 

 

Property and equipment, net of accumulated depreciation and amortization of $4,106 in 2013 and $3,627 in 2012

     1,825        1,483   

Other assets

     475        638   

Intangible assets, net of accumulated amortization of $12,034 in 2013 and $10,744 in 2012

     13,963        15,230   

Goodwill

     21,109        21,109   
  

 

 

   

 

 

 

Total assets

   $ 58,661      $ 59,993   
  

 

 

   

 

 

 
Liabilities and Stockholders’ Equity     

Current liabilities:

    

Accounts payable

   $ 2,018      $ 1,940   

Accrued and other expenses

     3,515        4,142   

Interest payable

     569        499   

Capital lease—short-term portion

     130        —     

Warrant liability

     1,054        1,538   

Deferred revenue

     7,498        6,520   
  

 

 

   

 

 

 

Total current liabilities

     14,784        14,639   
  

 

 

   

 

 

 

Deferred revenue, long-term portion

     1,633        1,502   

Other long-term liabilities

     1,313        1,341   

Capital lease—long-term portion

     279        —     

Notes payable

     15,299        14,846   
  

 

 

   

 

 

 

Total liabilities

     33,308        32,328   
  

 

 

   

 

 

 

Stockholders’ equity:

    

Preferred stock, $ .01 par value: authorized 1,000,000 shares; none issued

     —          —     

Common stock, $ .01 par value: authorized 85,000,000 shares; issued 11,036,075 in 2013 and 10,993,933 in 2012; outstanding 10,850,244 in 2013 and 10,808,102 in 2012

     110        110   

Additional paid-in capital

     166,302        165,416   

Accumulated deficit

     (139,644     (136,446

Treasury stock at cost, 185,831 shares in 2013 and 2012

     (1,415     (1,415
  

 

 

   

 

 

 

Total stockholders’ equity

     25,353        27,665   
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 58,661      $ 59,993   
  

 

 

   

 

 

 

 

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iCAD, INC. AND SUBSIDIARY

Condensed Consolidated Statements of Operations

(Unaudited)

(In thousands except for per share data)

 

     Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
     2013     2012     2013     2012  

Revenue:

        

Products

   $ 4,765      $ 5,661      $ 14,329      $ 13,248   

Service and supplies

     3,525        2,522        9,603        7,209   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

     8,290        8,183        23,932        20,457   

Cost of revenue:

        

Products

     1,383        1,527        4,184        3,603   

Service and supplies

     747        541        2,251        1,678   

Amortization of acquired intangibles

     234        233        701        698   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total cost of revenue

     2,364        2,301        7,136        5,979   
  

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit

     5,926        5,882        16,796        14,478   
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating expenses:

        

Engineering and product development

     2,112        1,971        5,734        6,158   

Marketing and sales

     2,617        2,842        7,392        7,976   

General and administrative

     1,551        1,773        4,825        4,971   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     6,280        6,586        17,951        19,105   
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (354     (704     (1,155     (4,627

Gain from change in fair value of warrant

     624        126        484        512   

Interest expense

     (807     (883     (2,467     (2,549

Other income

     4        9        16        27   
  

 

 

   

 

 

   

 

 

   

 

 

 

Other expense, net

     (179     (748     (1,967     (2,010

Loss before income tax expense

     (533     (1,452     (3,122     (6,637

Income tax expense

     (56     (13     (76     (35
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss and comprehensive loss

   $ (589   $ (1,465   $ (3,198   $ (6,672
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share:

        

Basic and diluted

   $ (0.05   $ (0.14   $ (0.30   $ (0.62
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average number of shares used in computing loss per share:

        

Basic and diluted

     10,849        10,805        10,835        10,792   
  

 

 

   

 

 

   

 

 

   

 

 

 

 

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iCAD, INC. AND SUBSIDIARY

Condensed Consolidated Statements of Cash Flows

(unaudited)

 

     For the nine months
ended September 30,
 
     2013     2012  
     (in thousands)  

Cash flow from operating activities:

    

Net loss

   $ (3,198   $ (6,672

Adjustments to reconcile net loss to net cash used for operating activities:

    

Depreciation

     528        701   

Amortization

     1,291        1,472   

Bad debt provision

     35        —     

Gain from change in fair value of warrant

     (484     (512

Loss on disposal of assets

     49        143   

Stock-based compensation expense

     908        731   

Amortization of debt discount and debt costs

     588        761   

Interest on settlement obligations

     214        313   

Changes in operating assets and liabilities:

    

Accounts receivable

     (3,474     (1,712

Inventory

     116        178   

Prepaid and other current assets

     (145     215   

Accounts payable

     78        1,106   

Accrued expenses

     (799     (2,172

Deferred revenue

     1,110        818   
  

 

 

   

 

 

 

Total adjustments

     15        2,042   
  

 

 

   

 

 

 

Net cash used for operating activities

     (3,183     (4,630
  

 

 

   

 

 

 

Cash flow from investing activities:

    

Additions to patents, technology and other

     (24     (3

Additions to property and equipment

     (510     (465
  

 

 

   

 

 

 

Net cash used for investing activities

     (534     (468
  

 

 

   

 

 

 

Cash flow from financing activities:

    

Issuance of common stock for cash

     3        —     

Taxes paid related to restricted stock issuance

     (25     (13

Proceeds from debt financing, net

     —          14,325   
  

 

 

   

 

 

 

Net cash (used for) provided by financing activities

     (22     14,312   
  

 

 

   

 

 

 

Increase (decrease) in cash and equivalents

     (3,739     9,214   

Cash and equivalents, beginning of period

     13,948        4,576   
  

 

 

   

 

 

 

Cash and equivalents, end of period

   $ 10,209      $ 13,790   
  

 

 

   

 

 

 

 

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RECONCILIATION OF NON-GAAP FINANCIAL MEASURES TO COMPARABLE GAAP MEASURES

(Unaudited, in thousands, except per share amounts)

The following is a reconciliation of the non-GAAP financial measures used by the Company to describe the Company’s financial results determined in accordance with United States generally accepted accounting principles (GAAP). An explanation of these measures is also included below under the heading “Explanation of Non-GAAP Financial Measures.”

While management believes that these non-GAAP financial measures provide useful supplemental information to investors regarding the underlying performance of the Company’s business operations, investors are reminded to consider these non-GAAP financial measures in addition to, and not as a substitute for, financial performance measures prepared in accordance with GAAP. In addition, it should be noted that these non-GAAP financial measures may be different from non-GAAP financial measures used by other companies, and management may utilize other measures to illustrate performance in the future. Non-GAAP financial measures have limitations in that they do not reflect all of the amounts associated with the Company’s results of operations as determined in accordance with GAAP.

Non-GAAP Adjusted EBITDA

Set forth below is a reconciliation of the Company’s “Non-GAAP Adjusted EBITDA”

(Unaudited, in thousands)

 

     Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
     2013     2012     2013     2012  

GAAP Net Loss

   $ (589   $ (1,465   $ (3,198   $ (6,672

Interest Expense

     807        883        2,467        2,549   

Other (expense) income

     (4     (9     (16     (27

Stock Compensation

     307        283        908        731   

Depreciation

     162        235        528        701   

Amortization

     430        426        1,290        1,472   

Tax expense (benefit)

     56        13        76        35   

Severance

     —          —          —          80   

Gain on warrant

     (624     (126     (484     (512
  

 

 

   

 

 

   

 

 

   

 

 

 

Non GAAP Adjusted EBITDA

   $ 545      $ 240      $ 1,571      $ (1,643
  

 

 

   

 

 

   

 

 

   

 

 

 

 

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Non-GAAP Adjusted Net Loss

Set forth below is a reconciliation of the Company’s “Non-GAAP Adjusted Net Loss”

(Unaudited, in thousands, except loss per share)

 

     Three Months Ended September 30,     Nine Months Ended September 30,  
     2013     2012     2013     2012  

GAAP Net Loss

   $ (589   $ (1,465   $ (3,198   $ (6,672

Adjustments to net loss:

        

Severance

     —          —          —          80   

Gain on warrant

     (624     (126     (484     (512
  

 

 

   

 

 

   

 

 

   

 

 

 

Non GAAP Adjusted Net Loss

   $ (1,213   $ (1,591   $ (3,682   $ (7,104
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share

        

GAAP Net loss per share

   $ (0.05   $ (0.14   $ (0.30   $ (0.62

Adjustments to net loss (as detailed above)

     (0.06     (0.01     (0.04     (0.04
  

 

 

   

 

 

   

 

 

   

 

 

 

Non GAAP Adjusted Net Loss per share

   $ (0.11   $ (0.15   $ (0.34   $ (0.66
  

 

 

   

 

 

   

 

 

   

 

 

 

Explanation of Non-GAAP Financial Measures

The Company reports its financial results in accordance with United States generally accepted accounting principles, or GAAP. However, management believes that in order to properly understand the Company’s short-term and long-term financial and operational trends, investors may wish to consider the impact of certain non-cash or non-recurring items, when used as a supplement to financial performance measures in accordance with GAAP. These items result from facts and circumstances that vary in frequency and/or impact on continuing operations. Management also uses results of operations before such items to evaluate the operating performance of the Company and compare it against past periods, make operating decisions, and serve as a basis for strategic planning. These non-GAAP financial measures provide management with additional means to understand and evaluate the operating results and trends in the Company’s ongoing business by eliminating certain non-cash expenses and other items that management believes might otherwise make comparisons of the Company’s ongoing business with prior periods more difficult, obscure trends in ongoing operations or reduce management’s ability to make useful forecasts. Management believes that these non-GAAP financial measures provide additional means of evaluating period-over-period operating performance. In addition, management understands that some investors and financial analysts find this information helpful in analyzing the Company’s financial and operational performance and comparing this performance to its peers and competitors.

Management defines “Non-GAAP Adjusted EBITDA” as the sum of GAAP net loss before provision for income taxes, acquisition-related expenses, total other (income) expense, stock-based compensation expense, depreciation and amortization, severance, gain on sale, loss on warrant, amortization of acquired intangibles, acquisition related, patent litigation and recall costs, contingent consideration, indemnification asset and goodwill impairment charges. Management considers this non-GAAP financial measure to be an important indicator of the Company’s operational strength and performance of its business and a good measure of its historical operating trends, in particular the extent to which ongoing operations impact the Company’s overall financial performance.

Management defines “Non-GAAP Adjusted Net Loss” as the sum of GAAP net loss before provision for the gain on sale of asset, severance, transaction, patent litigation and recall costs, contingent consideration, indemnification asset and goodwill impairment charges. Management considers this non-GAAP financial measure to be an important indicator of the Company’s operational strength and performance of its business and a good measure of its historical operating trends, in particular the extent to which ongoing operations impact the Company’s overall financial performance.

 

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Management excludes each of the items identified below from the applicable non-GAAP financial measure referenced above for the reasons set forth with respect to that excluded item:

 

    Stock-based compensation expense: excluded as these are non-cash expenses that management does not consider part of ongoing operating results when assessing the performance of the Company’s business, and also because the total amount of expense is partially outside of the Company’s control as it is based on factors such as stock price volatility and interest rates, which may be unrelated to our performance during the period in which the expense is incurred.

 

    Amortization of acquired intangibles: acquisition-related expenses are reported at the time acquisition costs are incurred, and purchased intangibles are amortized over a period of several years after the acquisition and generally cannot be changed or influenced by management after the acquisition. Accordingly, these items are not considered by management in making operating decisions, and management believes that such expenses do not have a direct correlation to future business operations. Thus, including such charges does not accurately reflect the performance of the Company’s ongoing operations for the period in which such charges are incurred.

 

    Interest expense: In January 2012, the Company entered into a five-year, $15 million debt facility agreement. The Company excludes interest expense from its non GAAP Adjusted EBITDA calculation.

 

    Severance: relates to costs incurred due to the termination of certain employees. The Company provides compensation to certain employees as an accommodation upon termination of employment without cause. Management believes that excluding severance costs from operating results provides investors with a better means for measuring current Company performance.

 

    Gain (loss) on Warrant: The Company issued warrants in connection with the financing and the value changes according to fair value. It is excluded as these are non-cash expenses that management does not consider part of ongoing operating results when assessing the performance of the Company’s business, also because the total amount of gain or loss is partially outside of the Company’s control as it is based on factors such as stock price volatility and interest rates, which may be unrelated to our performance during the period in which the gain or loss is incurred.

On occasion in the future, there may be other items, such as significant asset impairments, restructuring charges or significant gains or losses from contingencies that the Company may exclude if it believes that doing so is consistent with the goal of providing useful information to investors and management.

# # #

 

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