Form: 6-K

Report of foreign issuer [Rules 13a-16 and 15d-16]

November 5, 2020

Exhibit 99.2

 

 

PROFOUND MEDICAL CORP.

 

 

 

 

 

INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

SEPTEMBER 30, 2020

 

PRESENTED IN CANADIAN DOLLARS

 

 

 

 

 

 

 

Profound Medical Corp.

Interim Condensed Consolidated Balance Sheets

(Unaudited)

  

      September 30, 2020
$
      December 31, 2019
$
 
         
Assets                
                 
Current assets                
Cash     110,402,232       19,222,195  
Trade and other receivables (note 3)     6,325,986       4,058,136  
Investment tax credits receivable     -       240,000  
Inventory (note 4)     6,590,909       4,764,458  
Prepaid expenses and deposits     124,397       1,335,620  
Total current assets     123,443,524       29,620,409  
                 
Property and equipment (note 5)     799,184       684,718  
Intangible assets (note 6)     2,226,886       3,128,820  
Right-of-use assets (note 7)     1,916,734       2,199,381  
Goodwill     3,409,165       3,409,165  
                 
Total assets     131,795,493       39,042,493  
                 
Liabilities                
                 
Current liabilities                
Accounts payable and accrued liabilities     2,401,240       3,933,114  
Deferred revenue     565,991       654,763  
Long-term debt (note 8)     -       5,144,461  
Warranty provision     205,077       134,956  
Other liabilities (note 9)     104,848       286,858  
Derivative financial instrument (note 8)     496,843       254,769  
Lease liabilities (note 10)     388,723       258,685  
Income taxes payable     241,797       15,763  
Total current liabilities     4,404,519       10,683,369  
                 
Long-term debt (note 8)     -       6,719,924  
Deferred revenue     1,006,379       829,784  
Warranty provision     28,509       19,005  
Lease liabilities (note 10)     1,841,771       2,125,873  
                 
Total liabilities     7,281,178       20,377,955  
                 
Shareholders’ Equity                
                 
Share capital (note 11)     257,999,788       130,266,880  
Contributed surplus     16,511,270       19,580,338  
Accumulated other comprehensive gain/(loss)     160,265       (117,188 )
Deficit     (150,157,008 )     (131,065,492 )
                 
Total Shareholders’ Equity     124,514,315       18,664,538  
                 
Total Liabilities and Shareholders’ Equity     131,795,493       39,042,493  

 

The accompanying notes are an integral part of these interim condensed consolidated financial statements.

 

 

Profound Medical Corp.

Interim Condensed Consolidated Statements of Loss and Comprehensive Loss

(Unaudited)

 

     

Three

months ended September 30, 2020
$

     

Three

months ended September 30, 2019
$

     

Nine

months ended September 30, 2020
$

     

Nine

months ended September 30, 2019
$

 
                 
Revenue                                
Products     2,464,563       528,578       4,953,903       2,342,199  
Services     381,647       153,646       734,795       389,922  
Pay per procedure     134,500       -       273,453       -  
      2,980,710       682,224       5,962,151       2,732,121  
Cost of sales (note 13)     1,018,635       395,001       2,829,635       1,172,423  
Gross profit     1,962,075       287,223       3,132,516       1,559,698  
                                 
Operating Expenses (note 13)                                
Research and development     4,749,673       3,424,585       9,972,757       9,288,686  
General and administrative     2,481,281       2,054,099       7,809,595       5,154,535  
Selling and distribution     1,580,456       873,761       4,210,273       1,499,285  
Total operating expenses     8,811,410       6,352,445       21,992,625       15,942,506  
                                 
Operating Loss     6,849,335       6,065,222       18,860,109       14,382,808  
                                 
Net finance (income)/costs (note 14)     1,043,987       164,982       (328,100 )     564,216  
                                 
Loss before income taxes     7,893,322       6,230,204       18,532,009       14,947,024  
                                 
Income taxes     242,972       39,700       559,507       93,700  
                                 
Net loss for the period     8,136,294       6,269,904       19,091,516       15,040,724  
                                 
Other comprehensive loss (income)                                
Item that may be reclassified to profit or loss                                
Foreign currency translation adjustment - net of tax of $nil (2019 - $nil)     118,064       (49,193 )     277,453       (107,425 )
Net loss and comprehensive loss for the period     8,254,358       6,220,711       19,368,969       14,933,299  
                                 
Loss per share (note 15)                                
Basic and diluted net loss per share     0.43       0.57       1.16       1.39  

 

The accompanying notes are an integral part of these interim condensed consolidated financial statements.

 

 

 

Profound Medical Corp.

Interim Condensed Consolidated Statements of Changes in Shareholders’ Equity

(Unaudited)

 

      Number
of shares
      Share
capital
$
      Contributed
surplus
$
      Accumulated
other
comprehensive
income (loss)
$
      Deficit
$
      Total
$
 
                         
Balance – January 1, 2019     10,805,494       120,932,404       16,756,294       (28,703 )     (110,873,242 )     26,786,753  
                                                 
Net loss for the period     -       -       -       -       (15,040,724 )     (15,040,724 )
Cumulative translation adjustment – net of tax of $nil     -       -       -       (107,425 )     -       (107,425 )
Exercise of share options     1,800       10,080       (4,681 )     -       -       5,399  
Issuance of units from offering (note 11)     1,045,455       9,452,607       1,151,881       -       -       10,604,488  
Share-based compensation (note 12)     -       -       1,050,583       -       -       1,050,583  
Balance – September 30, 2019     11,852,749       130,395,091       18,954,077       (136,128 )     (125,913,966 )     (23,299,074 )
                                                 
Balance – January 1, 2020     11,852,749       130,266,880       19,580,338       (117,188 )     (131,065,492 )     18,664,538  
                                                 
Net loss for the period     -       -       -       -       (19,091,516 )     (19,091,516 )
Cumulative translation adjustment – net of tax of $nil     -       -       -       277,453       -       277,453  
Exercise of share options     152,384       2,610,703       (1,028,136 )     -       -       1,582,567  
Exercise of warrants     1,055,094       19,732,963       (4,844,078 )     -       -       14,888,885  
Issuance of common shares from offering (note 11)     6,564,914       105,389,242       -       -       -       105,389,242  
Share-based compensation (note 12)     -       -       2,803,146       -       -       2,803,146  
Balance – September 30, 2020     19,625,141       257,999,788       16,511,270       160,265       (150,157,008 )     124,514,315  

 

The accompanying notes are an integral part of these interim condensed consolidated financial statements.

 

 

 

Profound Medical Corp.

Interim Condensed Consolidated Statements of Cash Flows

(Unaudited)

 

      Nine months
ended
September 30,
2020
$
      Nine months
ended
September 30,
2019
$
 
         
Operating activities                
Net loss for the period     (19,091,516 )     (15,040,724 )
Adjustments to reconcile net loss to net cash flows from operating activities:                
Depreciation of property and equipment (note 5)     333,269       365,604  
Amortization of intangible assets (note 6)     901,934       846,329  
Depreciation of right-of-use assets (note 7)     306,548       305,389  
Share-based compensation (note 12)     2,803,146       1,050,583  
Interest and accretion expense (note 14)     727,886       1,028,680  
Deferred revenue     87,823       349,229  
Change in fair value of derivative financial instrument (note 8)     242,074       124,881  
Change in fair value of contingent consideration (note 9)     51,712       (371,561 )
Foreign exchange on cash     (345,200 )     -  
Changes in non-cash working capital balances                
Investment tax credits receivable     240,000       240,000  
Trade and other receivables     (2,267,850 )     1,211,476  
Prepaid expenses and deposits     1,211,223       (189,742 )
Inventory     (2,251,280 )     (18,986 )
Accounts payable and accrued liabilities     (1,286,992 )     (1,223,625 )
Provisions     79,625       (1,209,347 )
Income taxes payable     226,034       (297,353 )
Net cash flow used in operating activities     (18,031,564 )     (12,829,167 )
                 
Investing activities                
Purchase of intangible assets     -       (250,000 )
Total cash used in investing activities     -       (250,000 )
                 
Financing activities                
Issuance of common shares (note 11)     113,950,328       11,500,001  
Transaction costs paid (note 11)     (8,561,086 )     (895,513 )
Payment of other liabilities (note 9)     (233,722 )     (16,203 )
Payment of long-term debt and interest (note 8)     (12,497,993 )     (735,717 )
Proceeds from share options exercised (note 12)     1,582,567       5,399  
Proceeds from warrants exercised (note 11)     14,888,885       -  
Payment of lease liabilities (note 10)     (262,578 )     (238,684 )
Total cash from financing activities     108,866,401       9,619,283  
                 
Net change in cash during the period     90,834,837       (3,459,884 )
Foreign exchange on cash     345,200       -  
Cash – Beginning of period     19,222,195       30,687,183  
Cash – End of period     110,402,232       27,227,299  

 

The accompanying notes are an integral part of these interim condensed consolidated financial statements.

 

 

Profound Medical Corp.

Notes to Interim Condensed Consolidated Financial Statements

(Unaudited)

September 30, 2020

 

1 Description of business

 

Profound Medical Corp. (Profound) and its subsidiaries (together, the Company) were incorporated under the Ontario Business Corporations Act on July 16, 2014. The Company is a medical technology Company developing treatments to ablate the prostate gland, uterine fibroids and nerves for palliative pain relief for patients with metastatic bone disease.

 

The Company’s registered address is 2400 Skymark Avenue, Unit 6, Mississauga, Ontario, L4W 5K5.

 

 

2 Summary of significant accounting policies and basis of preparation

 

Basis of preparation

 

These interim condensed consolidated financial statements have been prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board (IFRS), applicable to the preparation of interim condensed consolidated financial statements, including International Accounting Standard (IAS) 34, Interim Financial Reporting. These interim condensed consolidated financial statements are presented in Canadian dollars and should be read in conjunction with the Company’s annual financial statements for the year ended December 31, 2019, which were prepared in accordance with IFRS.

 

These interim condensed consolidated financial statements were authorized for issue by the Board of Directors on November 5, 2020.

 

The interim condensed consolidated financial statements were prepared on a going concern basis under the historical cost convention, except for the derivative financial instrument and other liabilities which are measured at fair value

 

The accounting policies adopted are consistent with those of the previous financial year with the exception of new revenue recognition and share-based compensation accounting policies as outlined below in relation to the lease of medical devices and a long-term incentive plan.

 

Pay per procedure

 

The company generates revenue from the lease of medical devices and the sale of certain consumable goods. Customers are charged a fixed fee per use of the medical device, called a pay per procedure charge, which is charged each time a procedure is completed. Per use fees are recognized within pay per procedure revenue on the interim condensed consolidated statements of loss and comprehensive loss. The use of the medical device also requires the customer to purchase a consumable. The consumable is considered a non-lease component and is therefore recognized when control transfers to the customer. Consumable sales are recognized within product revenue on the interim condensed consolidated statements of loss and comprehensive loss. The consideration received is allocated between lease and non-lease components based on their stand-alone selling prices.

 

    (1)

Profound Medical Corp.

Notes to Interim Condensed Consolidated Financial Statements

(Unaudited)

September 30, 2020

 

Share-based compensation

 

The Company has a long-term incentive plan (LTIP) that was approved on May 20, 2020. For each Restricted Share Unit (RSU) or Deferred Share Unit (DSU) granted under the long-term incentive plan, the Company recognizes an expense equal to the market value of a Profound common share at the date of grant based on the number of RSUs and DSUs expected to vest, recognized over the term of the vesting period, with a corresponding credit to contributed surplus for share-based compensation anticipated to be equity settled or a corresponding credit to a liability for those anticipated to be cash settled. Share-based compensation expense is adjusted for subsequent changes in management’s estimate of the number of RSUs or DSUs that are expected to vest and, for RSUs or DSUs anticipated to be cash settled, changes in the market value of Profound common shares. The effect of these changes is recognized in the period of the change. Vested RSUs and DSUs are settled either in Profound common shares or in cash or a combination thereof at the discretion of the Company.

 

COVID-19

 

The COVID-19 outbreak has been declared a pandemic by the World Health Organization. It is too soon to gauge the impacts of the current outbreak, given the many unknowns related to COVID-19 including the duration and severity of the outbreak. COVID-19 is altering business and consumer activity in affected areas and beyond. The global response to the COVID-19 pandemic has resulted in, among other things, border closures, severe travel restrictions, the temporary shut-down of non-essential services and fluctuations in financial and commodity markets. Additional measures may be implemented by one or more governments in jurisdictions where the Company operates. These measures have caused material disruption to businesses globally, resulting in an economic slowdown. The extent to which COVID-19 and any other pandemic or public health crisis impacts the Company’s business, affairs, operations, financial condition, liquidity, availability of credit and results of operations will depend on future developments that are highly uncertain and cannot be predicted with any meaningful precision, including new information which may emerge concerning the severity of the COVID-19 virus and the actions required to contain the COVID-19 virus or remedy its impact, among others.

 

From an operational perspective, the Company’s employees, direct sales and marketing teams and distribution partners, as well as the workforce of vendors, services providers and counterparties with which the Company does business, are also adversely affected by the COVID-19 pandemic or efforts to mitigate the pandemic, including government-mandated shutdowns, requests or orders for employees to work remotely, and other physical distancing measures, which has had an adverse impact on the Company’ ability to conduct its businesses, including its ability to cultivate adoption of the TULSA-PRO and Sonalleve technology, support clinical customers with the TULSA-PRO procedures and increase the utilization of the systems and disposable components.

 

To date, the economic downturn and uncertainty caused by the COVID-19 pandemic and global measures undertaken to contain its spread have affected all of the Company’s operations to some extent and, in particular, have caused volatility in demand for the TULSA-PRO and Sonalleve systems and the disposable components related to the TULSA-PRO system. This has resulted in a reduction in anticipated sales and led to delays in the Company’s expectations regarding the rate at which agreements for new TULSA-PRO user sites will be entered into and when user sites will become operational for the initiation of patient treatments. Despite the COVID-19 pandemic, patient treatments are continuing and Profound continues to identify potential new TULSA-PRO and Sonalleve user sites. The Company continues to evaluate the current and potential impact of the COVID-19 pandemic on its business, affairs, operations, financial condition, liquidity, availability of credit and results of operations.

 

    (2)

Profound Medical Corp.

Notes to Interim Condensed Consolidated Financial Statements

(Unaudited)

September 30, 2020

In addition, the actual and threatened spread of COVID-19 globally could also have a material adverse effect on the regional economies in which Profound operates, could continue to negatively impact stock markets, including the trading price of the Common Shares, could adversely impact the Company’s ability to raise capital, could cause continued interest rate volatility and movements that could make obtaining financing more challenging or more expensive.

 

3 Trade and other receivables

 

The trade and other receivables balance comprises the following:

 

      September 30, 2020
$
      December 31, 2019
$
 
         
Trade receivables     5,471,775       2,588,470  
Interest receivable     -       32,287  
Tax receivables     674,092       1,108,340  
Other receivables     180,119       329,039  
Total trade and other receivables     6,325,986       4,058,136  

 

Amounts past due represent trade receivables past due based on the customer’s contractual terms. The Company applies the simplified approach to providing for expected credit losses prescribed by IFRS 9, which permits the use of the lifetime expected loss provision for all trade receivables. At September 30, 2020 there was $752,632 past due but not impaired compared to December 31, 2019, whereby no trade receivables were past due.

 

 

4 Inventory

 

      September 30, 2020
$
      December 31, 2019
$
 
         
Finished goods     3,180,628       2,384,704  
Raw materials     3,418,983       2,403,652  
Inventory provision     (8,702 )     (23,898 )
Total inventory     6,590,909       4,764,458  

 

During the three and nine months ended September 30, 2020, $929,508 and $2,699,391 (three and nine months ended September 30, 2019, $377,997 and $1,104,399, respectively) of inventory was recognized in cost of sales. The Company decreased its inventory provision by $239,779 and $15,196 during the three and nine months ended September 30, 2020 (three and nine months ended September 30, 2019 – decrease of $5,845 and $23,687).

 

    (3)

Profound Medical Corp.

Notes to Interim Condensed Consolidated Financial Statements

(Unaudited)

September 30, 2020

5 Property and equipment

 

Equipment under lease is depreciated on a straight-line basis over a period of two years.

 

Property and equipment consist of the following:

 

   

 

Furniture

and

fittings

$

 

 

 

Research

and

manufacturing

equipment

$

 

   

Leasehold

improvements

$

 

    Equipment under lease
$
   

 

Total

$

 

                     
At January 1, 2020                                        
Cost     235,169       1,386,692       718,742       -       2,340,603  
Accumulated depreciation     (176,922 )     (1,227,445 )     (251,518 )     -       (1,655,885 )
Net book value     58,247       159,247       467,224       -       684,718  
                                         
Nine months ended September 30, 2020                                        
Opening net book value     58,247       159,247       467,224       -       684,718  
Addition     -       -       -       424,829       424,829  
Foreign exchange     -       22,906       -       -       22,906  
Depreciation     (40,151 )     (182,153 )     (51,961 )     (59,004 )     (333,269 )
Closing net book value     18,096       -       415,263       365,825       799,184  
                                         
At September 30, 2020                                        
Cost     235,169       1,386,692       718,742       424,829       2,765,432  
Accumulated depreciation     (217,073 )     (1,386,692 )     (303,479 )     (59,004 )     (1,966,248 )
Net book value     18,096       -       415,263       365,825       799,184  

 

 

6 Intangible assets

 

Intangible assets consist of the following:

 

      Exclusive
licence
agreement
$
      Software
$
      Proprietary
technology
$
      Brand
$
      Total
$
 
                     
As at January 1, 2020                                        
Cost     300,000       257,254       4,489,295       883,140       5,929,689  
Accumulated amortization     (33,802 )     (170,390 )     (2,169,826 )     (426,851 )     (2,800,869 )
Net book value     266,198       86,864       2,319,469       456,289       3,128,820  
                                         
Nine months ended September 30, 2020                                        
Opening net book value     266,198       86,864       2,319,469       456,289       3,128,820  
Amortization     (20,781 )     (75,288 )     (673,394 )     (132,471 )     (901,934 )
Closing net book value     245,417       11,576       1,646,075       323,818       2,226,886  
                                         
As at September 30, 2020                                        
Cost     300,000       257,254       4,489,295       883,140       5,929,689  
Accumulated amortization     (54,583 )     (245,678 )     (2,843,220 )     (559,322 )     (3,702,803 )
Net book value     245,417       11,576       1,646,075       323,818       2,226,886  

 

    (4)

Profound Medical Corp.

Notes to Interim Condensed Consolidated Financial Statements

(Unaudited)

September 30, 2020

7 Right-of-use assets

 

      Leased premises
$
 
     
As at January 1, 2020        
Cost     2,616,773  
Accumulated depreciation     (417,392 )
Net book value     2,199,381  
         
Nine months ended September 30, 2020        
Opening net book value     2,199,381  
Foreign exchange     23,901  
Depreciation     (306,548 )
Closing net book value     1,916,734  
         
As at September 30, 2020        
Cost     2,616,773  
Accumulated depreciation     (700,039 )
Net book value     1,916,734  

 

The Company leases office premises in Mississauga, Canada and Vantaa, Finland. These lease agreements are typically entered into for four to ten-year periods.

 

 

8 Long-term debt

 

A summary of the long-term debt is as follows:

 

      September 30, 2020
$
      December 31, 2019
$
 
         
CIBC loan     -       11,864,385  
Less: Current portion     -       5,144,461  
Long-term portion     -       6,719,924  

 

On July 30, 2018, the Company signed a term loan agreement with CIBC Innovation Banking (CIBC) to provide a secured loan for total gross proceeds of $12,500,000 maturing on July 29, 2022 with an interest rate based on prime plus 2.5%. All obligations of the Company under the term loan agreement were guaranteed by current and future subsidiaries of the Company and included security of first priority interests in the assets of the Company and its subsidiaries. On February 4, 2020, the full outstanding amount of the CIBC loan at that date, plus accrued interest, was repaid for a total payment of $12,041,032.

 

      September 30, 2020
$
      December 31, 2019
$
 
         
Balance - Beginning of period     11,864,385       11,955,245  
Interest and accretion expense     633,608       1,240,911  
Scheduled and final repayments     (12,497,993 )     (1,331,771 )
Balance - End of period     -       11,864,385  
Less: Current portion     -       5,144,461  
Long-term portion     -       6,719,924  

 

    (5)

Profound Medical Corp.

Notes to Interim Condensed Consolidated Financial Statements

(Unaudited)

September 30, 2020

In connection with this term loan agreement on July 31, 2018, the Company also issued 32,171 common share purchase warrants to CIBC, with each warrant entitling the holder to acquire one common share at a price of $9.70 per common share until the date that is 60 months from the closing of the term loan agreement, with a cashless exercise feature. The cashless exercise feature causes the conversion ratio to be variable and the warrants are therefore classified as a financial liability. Gains and losses on the warrants are recorded within finance costs on the consolidated statements of loss and comprehensive loss. A pricing model with observable market based inputs was used to estimate the fair value of the warrants issued. The estimated fair value of the warrants as at September 30, 2020 and December 31, 2019 was $496,843 and $254,769, respectively. The variables used to determine the fair values are as follows:

 

      September 30, 2020       December 31, 2019  
         
Share price   $ 23.42     $ 14.75  
Volatility     63 %     54 %
Expected life of warrants     2.8 years       3.6 years  
Risk free interest rate     0.23 %     1.68 %
Dividend yield     -       -  

 

 

9 Other liabilities

 

      Contingent
consideration
$
 
     
As at January 1, 2020     286,858  
Amounts paid     (233,722 )
Change in fair value (note 14)     51,712  
As at September 30, 2020     104,848  
Less: Current portion     104,848  
Long-term portion     -  

 

Contingent consideration

 

On July 31, 2017, the Company entered into an Asset and Share Purchase Agreement (the agreement) to acquire all of the issued and outstanding shares and certain assets of Royal Philips’ (Philips) Sonalleve MR-HIFU business (Sonalleve). The agreement includes certain contingent consideration payments payable monthly in euro tied to future revenue levels of the Sonalleve business summarized as follows:

 

· 5% of revenue between the date of acquisition and December 31, 2017;

 

· 6% of revenue during the year ending December 31, 2018;

 

· 7% of revenue during the years ending December 31, 2019 and 2020; and

 

· if total revenues are in excess of a defined amount from the date of acquisition to December 31, 2020, then the Company will be required to pay 7% of revenue from the date of acquisition to December 31, 2019.

 

    (6)

Profound Medical Corp.

Notes to Interim Condensed Consolidated Financial Statements

(Unaudited)

September 30, 2020

The contingent consideration is classified as a Level 3 financial liability within the fair value hierarchy given its fair value is estimated using the discounted value of estimated future payments. The key assumptions in valuing the contingent consideration include: estimated projected net sales; the likelihood of certain levels being reached; and a discount rate of 15%.

 

 

10 Lease liabilities

 

      September 30, 2020
$
      December 31, 2019
$
 
         
As at January 1     2,384,558       2,587,727  
Repayments     (262,578 )     (318,245 )
Foreign exchange     14,236       (17,391 )
Interest expense (note 14)     94,278       132,467  
Balance - End of period     2,230,494       2,384,558  
Less: Current portion     388,723       258,685  
Long-term portion     1,841,771       2,125,873  

 

 

11 Share capital

 

Common shares

 

The Company is authorized to issue an unlimited number of common shares.

 

Issued and outstanding (with no par value)

 

      September 30, 2020
$
      December 31, 2019
$
 
         
19,625,141 (December 31, 2019 – 11,852,749) common shares     257,999,788       130,266,880  

 

On January 27, 2020, the Company closed an offering, resulting in the issuance of 3,392,500 common shares at a price of US$11.65, for gross proceeds of US$39,522,625 ($47,946,651, net of transaction costs).

 

On July 21, 2020, the Company closed an offering, resulting in the issuance of 3,172,414 common shares at a price of US$14.50, for gross proceeds of US$46,000,003 ($57,442,591, net of transaction costs).

 

    (7)

Profound Medical Corp.

Notes to Interim Condensed Consolidated Financial Statements

(Unaudited)

September 30, 2020

 

Warrants

 

A summary of warrants outstanding is shown below:

 

      Number of
warrants
      Weighted
average
exercise
price
$
   

 

Weighted

average remaining contractual life (years)

 

             
Balance - January 1, 2020     2,779,898       14.20       2.49  
Exercised     (1,055,094 )     14.11       1.16  
Balance - September 30, 2020     1,724,804       14.23       2.09  

 

 

12 Share-based payments

 

Options

 

Compensation expense related to share options for the three and nine months ended September 30, 2020 was $1,306,931 and $2,795,198, respectively (three and nine months ended September 30, 2019 - $594,156 and $1,050,583, respectively).

 

A summary of the share option changes during the period presented and the total number of share options outstanding as at those dates are set forth below:

 

   

 

Number

of options

 

 

 

Weighted average exercise price

$

 

         
Balance - January 1, 2020     1,109,943       10.51  
Granted     580,855       17.31  
Exercised     (152,384 )     10.39  
Forfeited/expired     (13,613 )     10.64  
Balance - September 30, 2020     1,524,801       13.11  

 

The Company estimated the fair value of the share options granted during the period using the Black-Scholes option pricing model with the weighted average assumptions below. Due to the absence of Company-specific volatility rates for the expected life of the share options, the Company chose comparable companies in the medical device industry.

 

 

      March 12,
2020
      May 20,
2020
      June 8,
2020
     

August 17,

2020

 
                 
Exercise price   $ 15.15     $ 17.44     $ 16.87     $ 20.39  
Expected volatility     82 %     84 %     84 %     83 %
Expected life of options     6 years       6 years       6 years       6 years  
Risk-free interest rate     0.60 %     0.46 %     0.58 %     0.48 %
Dividend yield     -       -       -       -  
Number of share options issued     16,550       481,405       80,000       2,900  

 

    (8)

Profound Medical Corp.

Notes to Interim Condensed Consolidated Financial Statements

(Unaudited)

September 30, 2020

The following table summarizes information about the share options outstanding as at September 30, 2020:

 

 

Exercise price

$

 

 

 

Number of

options

outstanding

 

 

 

Weighted average

remaining contractual

life (years)

 

 

 

Number of

options

exercisable

 

             
  2.40       11,300       2.13       11,300  
  6.00       3,300       8.14       1,100  
  8.50       29,291       7.13       20,660  
  9.10       10,300       8.62       3,429  
  9.20       476,190       8.63       157,906  
  9.30       50,000       7.90       26,046  
  9.70       4,950       6.57       4,950  
  9.90       2,300       7.49       1,433  
  10.20       9,900       7.71       7,700  
  11.00       58,409       6.20       47,238  
  11.23       81,500       9.14       -  
  11.90       51,300       7.64       29,927  
  13.50       8,300       5.86       8,300  
  14.60       93,406       5.89       93,406  
  15.00       55,800       4.91       55,800  
  15.15       16,550       9.45       -  
  16.87       80,000       9.69       -  
  17.44       479,605       9.64       -  
  20.39       2,400       9.88       -  
          1,524,801       8.48       469,195  

 

Long-term incentive plan

 

Share-based compensation expense related to long-term incentive plan (LTIP) for the three and nine months ended September 30, 2020 was $5,409 and $7,948, respectively (three and nine months ended September 30, 2019 - $nil and $nil, respectively).

 

A summary of the RSUs changes during the period are set forth below:

 

      Number of RSUs  
     
Balance - January 1, 2020     -  
Granted     3,917  
Forfeited     (200 )
Balance - September 30, 2020     3,717  

 

    (9)

Profound Medical Corp.

Notes to Interim Condensed Consolidated Financial Statements

(Unaudited)

September 30, 2020

 

13 Nature of expenses

 

      Three months
ended
September 30,
2020
$
      Three months
ended
September 30,
2019
$
      Nine months
ended
September 30,
2020
$
      Nine months
ended
September 30,
2019
$
 
                 
Production and manufacturing costs     890,492       261,922       2,169,656       726,399  
Salaries and benefits     3,249,857       2,373,144       9,108,140       7,385,320  
Consulting fees     831,799       1,584,146       3,387,368       3,881,911  
Research and development expense     2,381,020       1,019,344       2,820,014       2,116,129  
Sales and marketing expenses (recovery)     160,019       183,651       533,178       (513,304 )
Amortization and depreciation     515,988       491,678       1,541,751       1,517,706  
Share-based compensation     1,312,340       594,155       2,803,146       1,050,582  
Rent     52,965       77,836       214,817       293,969  
Software/Hardware     161,991       53,998       524,993       186,250  
Insurance     430,090       23,458       1,292,523       79,192  
Other expenses     (156,516 )     84,114       426,674       390,775  
      9,830,045       6,747,446       24,822,260       17,114,929  

 

Salaries and benefits are net of government assistance of $nil and $504,297 for the three and nine months ended September 30, 2020 (three and nine months ended September 30, 2019 - $nil).

 

Research and development expenses are net of reimbursements of $106,581 and $246,625 for the three and nine months ended September 30, 2020 (three and nine months ended September 30, 2019 - $nil).

 

14 Finance costs/(income)

 

      Three months
ended
September 30,
2020
$
      Three months
ended
September 30,
2019
$
      Nine months
ended
September 30,
2020
$
      Nine months
ended
September 30,
2019
$
 
                 
CIBC loan (note 8)     -       316,534       633,608       934,093  
Change in fair value of contingent consideration (note 9)     40,132       (162,650 )     51,712       (371,561 )
Change in fair value of derivative financial instrument (note 8)     9,608       70,661       242,074       124,881  
Lease liability interest expense (note 10)     31,020       30,888       94,278       98,037  
Royalty interest accretion recovery     -       -       -       (3,450 )
Interest income     (310,621 )     (104,631 )     (629,291 )     (357,302 )
Foreign exchange (gain) loss     1,273,848       14,180       (720,481 )     139,518  
      1,043,987       164,982       (328,100 )     564,216  

 

    (10)

Profound Medical Corp.

Notes to Interim Condensed Consolidated Financial Statements

(Unaudited)

September 30, 2020

Foreign currency risk occurs as a result of foreign exchange rate fluctuations between the time a transaction is recorded and the time it is settled.

 

The Company purchases goods and services denominated in foreign currencies and, accordingly, is subject to foreign currency risk, primarily the US dollar and Euro. Foreign currency risk arises from future commercial transactions and recognized assets and liabilities denominated in a currency that is not the functional currency. The risk is measured through a forecast of highly probable US dollar and Euro expenditures. The Company’s financial instruments denominated in foreign currencies are shown below in Canadian dollars.

 

                    September 30,
2020
 
      US
dollars
$
      Euro
$
      Canadian
dollars
$
      Total
$
 
                 
Cash     88,293,786       1,527,395       20,581,051       110,402,232  
Trade and other receivables     4,331,472       1,751,800       242,714       6,325,986  
Accounts payable and accrued liabilities     (101,304 )     (1,564,492 )     (735,444 )     (2,401,240 )
Other liabilities     -       (104,848 )     -       (104,848 )
Lease liabilities     -       (150,852 )     (2,079,642 )     (2,230,494 )
                                 

 

As at September 30, 2020, if foreign exchange rates had been 5% higher, with all other variables held constant, loss before income taxes would have been $4,699,148 higher, mainly as a result of the translation of foreign currency denominated cash, trade and other receivables, accounts payable and accrued liabilities, other liabilities and lease liabilities.

 

The Company does not use derivatives to reduce exposure to foreign currency risk.

 

 

15 Loss per share

 

The following table shows the calculation of basic and diluted loss per share:

 

      Three months
ended
September 30,
2020
$
      Three months
ended
September 30,
2019
$
      Nine months
ended
September 30,
2020
$
      Nine months
ended
September 30,
2019
$
 
                 
Net loss for the period   $ 8,136,294     $ 6,269,904     $ 19,091,516     $ 15,040,724  
Weighted average number of common shares     18,708,547       10,922,179       16,485,795       10,844,613  
Basic and diluted loss per share   $ 0.43     $ 0.57     $ 1.16     $ 1.39  

 

Of the 1,524,801 (September 30, 2019 – 1,027,743) share options, 3,717 (September 30, 2019 – nil) RSUs and 1,724,804 (September 30, 2019 – 2,779,899) warrants not included in the calculation of diluted loss per share for the period ended September 30, 2020, 2,193,999 (September 30, 2019 – 3,128,215) were exercisable.

 

    (11)

Profound Medical Corp.

Notes to Interim Condensed Consolidated Financial Statements

(Unaudited)

September 30, 2020

16 Related party transactions

 

Key management includes the Company’s directors and senior management team. The remuneration of directors and the senior management team was as follows:

 

      Three months
ended
September 30,
2020
$
      Three months
ended
September 30,
2019
$
      Nine months
ended
September 30,
2020
$
      Nine months
ended
September 30,
2019
$
 
                 
Salaries and employee benefits     285,018       315,258       1,526,848       1,012,106  
Directors’ fees     34,437       29,375       94,622       104,375  
Share-based compensation     636,701       426,849       1,604,649       799,019  
      956,156       771,482       3,226,119       1,915,500  

 

Executive employment agreements allow for additional payments in the event of a liquidity event, or if the executive is terminated without cause.

 

 

17 Segment reporting

 

The Company’s operations are categorized into one industry segment, which is medical technology focused on magnetic resonance guided ablation procedures for the treatment of prostate disease, uterine fibroids and palliative pain treatment for patients with metastatic bone disease. The Company is managed geographically in Canada, USA, Germany and Finland.

 

For the three-months ended September 30, 2020:

 

      Canada
$
      USA
$
      Germany
$
      Finland
$
      Total
$
 
                     
Revenue                    
Product     2,147,807       -       316,756       -       2,464,563  
Services     12,608       -       369,039       -       381,647  
Pay per procedure     134,500       -       -       -       134,500  
      2,294,915       -       685,795       -       2,980,710  
Cost of sales     367,489       -       651,146       -       1,018,635  
Gross profit     1,927,426       -       34,649       -       1,962,075  
                                         
Operating expenses                                        
Research and development     2,541,593       212,764       -       1,995,316       4,749,673  
General and administrative     2,216,018       204,980       -       60,283       2,481,281  
Selling and distribution     678,495       470,258       431,417       286       1,580,456  
Total operating expenses     5,436,106       888,002       431,417       2,055,885       8,811,410  
                                         
Operating loss     3,508,680       888,002       396,768       2,055,885       6,849,335  
Net finance costs                                     1,043,987  
Loss for the period before income taxes                                     7,893,322  

 

    (12)

Profound Medical Corp.

Notes to Interim Condensed Consolidated Financial Statements

(Unaudited)

September 30, 2020

For the nine-months ended September 30, 2020:

 

      Canada
$
      USA
$
      Germany
$
      Finland
$
      Total
$
 
                     
Revenue                    
Product     3,335,331       -       1,618,572       -       4,953,903  
Services     99,573       -       635,222       -       734,795  
Pay per procedure     273,453       -       -       -       273,453  
      3,708,357       -       2,253,794       -       5,962,151  
Cost of sales     939,391       -       1,890,244       -       2,829,635  
Gross profit     2,768,966       -       363,550       -       3,132,516  
                                         
Operating expenses                                        
Research and development     7,274,008       609,805       -       2,088,944       9,972,757  
General and administrative     6,504,252       1,069,955       -       235,388       7,809,595  
Selling and distribution     1,802,394       1,064,979       1,341,844       1,056       4,210,273  
Total operating expenses     15,580,654       2,744,739       1,341,844       2,325,388       21,992,625  
                                         
Operating loss     12,811,688       2,744,739       978,294       2,325,388       18,860,109  
Net finance income                                     (328,100 )
Loss for the period before income taxes                                     18,532,009  

 

 

For the three-month period ended September 30, 2019:

 

      Canada
$
      Germany
$
      Finland
$
      Total
$
 
                 
Revenue                
Product     41,646       486,932       -       528,578  
Services     66,954       86,692       -       153,646  
      108,600       573,624       -       682,224  
Cost of sales     31,400       363,601       -       395,001  
Gross profit     77,200       210,023       -       287,223  
                                 
Operating expenses                                
Research and development     2,688,549       -       736,036       3,424,585  
General and administrative     1,940,752       -       113,347       2,054,099  
Selling and distribution     467,463       388,848       17,450       873,761  
Total operating expense     5,096,764       388,848       866,833       6,352,445  
                                 
Operating loss     5,019,564       178,825       866,833       6,065,222  
Net finance costs                             164,982  
Loss for the period before income taxes                             6,230,204  

 

    (13)

Profound Medical Corp.

Notes to Interim Condensed Consolidated Financial Statements

(Unaudited)

September 30, 2020

 

For the nine-month period ended September 30, 2019:

 

      Canada
$
      Germany
$
      Finland
$
      Total
$
 
                 
Revenue                                
Product     1,330,777       1,011,422       -       2,342,199  
Services     98,722       291,200       -       389,922  
      1,429,499       1,302,622       -       2,732,121  
Cost of sales     246,540       925,883       -       1,172,423  
Gross profit     1,182,959       376,739       -       1,559,698  
                                 
Operating expenses                                
Research and development     7,132,765       -       2,155,921       9,288,686  
General and administrative     4,849,163       -       305,372       5,154,535  
Selling and distribution     134,872       1,178,297       186,116       1,499,285  
Total operating expense     12,116,800       1,178,297       2,647,409       15,942,506  
                                 
Operating loss     10,933,841       801,558       2,647,409       14,382,808  
Net finance costs                             564,216  
Loss for the period before income taxes                             14,947,024  

 

 

Other financial information by segment as at September 30, 2020:

 

      Canada
$
      USA
$
      Germany
$
      Finland
$
      Total
$
 
                     
Total assets     126,013,383       261,406       2,022,064       3,498,640       131,795,493  
Goodwill and intangible assets     5,636,051       -       -       -       5,636,051  
Property and equipment     799,184       -       -       -       799,184  
Right-of-use assets     1,760,360       -       -       156,374       1,916,734  
Amortization of intangible assets     901,934       -       -       -       901,934  
Depreciation of property and equipment     191,284       -       -       141,985       333,269  
Depreciation of right-of-use assets     220,045       -       -       86,503       306,548  

 

 

Other financial information by segment as at December 31, 2019:

 

      Canada
$
      Germany
$
      Finland
$
      Total
$
 
                 
Total assets     34,894,056       1,056,759       3,091,678       39,042,493  
Goodwill and intangible assets     6,537,985       -       -       6,537,985  
Property and equipment     565,638       -       119,080       684,718  
Right-of-use assets     1,980,405       -       218,976       2,199,381  
Amortization of intangible assets     1,134,741       -       -       1,134,741  
Depreciation of property and equipment     231,657       267       240,761       472,685  
Depreciation of right-of-use assets     293,393       -       113,004       406,397  

 

(14)