UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.  20549

FORM 10‑Q

Quarterly Report Under Section 13 or 15(d) of
The Securities Exchange Act of 1934



⌧     QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For quarter ended:the quarterly period ended September 30, 20182019
OR
□     TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from_________to__________
Commission File No. 001-12575


UTAH MEDICAL PRODUCTS INC.INC
(Exact name of Registrant as specified in its charter)


UTAH
87‑0342734
(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)

7043 South 300 West
7043 South 300 West
Midvale, Utah  84047
Address of principal executive offices

(Address of principal executive offices) (Zip Code)

Registrant's telephone number:
(801) 566‑1200
(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:
Title of each class:
Trading Symbol:
Name of each exchange on which registered:
Common stock, $0.01 par valueUTMDNASDAQ

 Indicate by check mark whether the registrant (1) has filed all reports required to be filed by SectionsSection 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) and;, and (2) has been subject to such filing requirements for the past 90 days.   Yes ⌧   No □

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).   Yes ⌧   No 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,fi ler, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of "large“large accelerated filer," "accelerated filer", "smaller” “accelerated filer,” “smaller reporting company",company,” and "emerging“emerging growth company"company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer 
Accelerated filer 
Non-accelerated filer
Smaller reporting company
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. 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).  Yes    No 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).   Yes ☒   No

Indicate the number of shares outstanding of each of the issuer'sissuer’s classes of common stock as of November 6, 2018: 3,734,200.
2019: 3,721,125.

UTAH MEDICAL PRODUCTS, INC.
INDEX TO FORM 10‑Q



PART I - FINANCIAL INFORMATIONPAGE
 Item 1.Financial Statements 
    
  Consolidated Condensed Balance Sheets as of September 30, 20182019 and December 31, 201720181
    
  Consolidated Condensed Statements of Income for the three and nine months ended September 30, 20182019 and September 30, 201720182
    
  Consolidated Condensed Statements of Cash Flows for the nine months ended September 30, 20182019 and September 30, 201720183
Consolidated Condensed Statements of Stockholders’ Equity for the three and nine months ended September 30, 2019 and September 30, 2018
4
    
  Notes to Consolidated Condensed Financial Statements45
    
 Item 2.Management'sManagement’s Discussion and Analysis of Financial Condition and Results of Operations69
    
 Item 3.Quantitative and Qualitative Disclosures About Market Risk1519
    
 Item 4.Controls and Procedures1519
    
PART II – OTHER INFORMATION 
    
 Item 1.Legal Proceedings1620
    
 Item 1A.Risk Factors1620
    
 Item 2.Unregistered Sales of Equity Securities and Use of Proceeds1721
    
 Item 6.Exhibits1822
    
SIGNATURES  
18
SIGNATURES23


PART I - FINANCIAL INFORMATION
PART I - FINANCIAL INFORMATION
 
  
Item 1.  Financial Statements      
UTAH MEDICAL PRODUCTS, INC. AND SUBSIDIARIES
 
CONSOLIDATED CONDENSED BALANCE SHEETS AS OF 
SEPTEMBER 30, 2019 AND DECEMBER 31, 2018 
(in thousands) 
    (unaudited)  (audited) 
ASSETS 
SEPTEMBER 30,
2019
  
DECEMBER 31,
2018
 
Current assets:      
Cash & investments $37,393  $51,112 
Accounts & other receivables, net  5,067   3,956 
Inventories  6,711   5,412 
Other current assets  342   423 
Total current assets  49,513   60,903 
Property and equipment, net  9,844   10,359 
Operating lease - right of use assets, net  422   - 
Goodwill  13,468   13,703 
Other intangible assets  52,875   32,979 
Other intangible assets - accumulated amortization  (22,028)  (18,176)
Other intangible assets, net  30,847   14,803 
Total assets $104,094  $99,768 
         
LIABILITIES AND STOCKHOLDERS' EQUITY        
Current liabilities:        
Accounts payable $785  $975 
Accrued expenses  2,901   4,285 
Total current liabilities  3,686   5,260 
Deferred tax liability - Femcare IIA  2,170   2,540 
Other long term liabilities  2,441   2,441 
Operating lease liability  385   - 
Deferred income taxes  426   535 
Total liabilities  9,108   10,776 
         
Stockholders' equity:        

        
Preferred stock - $.01 par value; authorized - 5,000 shares; no shares issued or outstanding
  -   - 
Common stock - $.01 par value; authorized - 50,000 shares; issued - September 30, 2019, 3,720 shares and  December 31, 2018, 3,720 shares
  37   37 
Accumulated other comprehensive income (loss)  (12,490)  (11,290)
Additional paid-in capital  -   122 
Retained earnings  107,439   100,123 
Total stockholders' equity  94,986   88,992 
         
Total liabilities and stockholders' equity $104,094  $99,768 
Item 1.  Financial Statements
UTAH MEDICAL PRODUCTS, INC. AND SUBSIDIARIES 
CONSOLIDATED CONDENSED BALANCE SHEETS AS OF 
SEPTEMBER 30, 2018 AND DECEMBER 31, 2017 
(in thousands) 
    (unaudited)  (audited) 
ASSETS
 
SEPTEMBER 30,
2018
  
DECEMBER 31,
2017
 
Current assets:      
Cash $49,352  $39,875 
Investments, available-for-sale  0   80 
Accounts & other receivables, net  4,476   3,623 
Inventories  4,920   5,244 
Other current assets  307   366 
Total current assets  59,055   49,188 
Property and equipment, net  10,574   11,621 
Goodwill  13,854   14,092 
Other intangible assets  33,693   34,805 
Other intangible assets - accumulated amortization  (18,024)  (16,961)
Other intangible assets, net  15,669   17,844 
Total assets $99,152  $92,745 
         
LIABILITIES AND STOCKHOLDERS' EQUITY
        
Current liabilities:        
Accounts payable $668  $934 
Accrued expenses  4,102   4,346 
Total current liabilities  4,770   5,280 
Deferred tax liability - intangible assets  2,698   3,102 
Other long term liabilities  2,441   5,785 
Deferred income taxes  412   456 
Total liabilities  10,321   14,623 
         
Stockholders' equity:        
Preferred stock - $.01 par value; authorized - 5,000 shares; no shares issued or outstanding  -   - 
Common stock - $.01 par value; authorized - 50,000 shares; issued - September 30, 2018, 3,734 shares and  December 31, 2017, 3,721 shares  37   37 
Accumulated other comprehensive income (loss)  (10,261)  (8,341)
Additional paid-in capital  1,297   809 
Retained earnings  97,758   85,617 
Total stockholders' equity  88,831   78,122 
         
Total liabilities and stockholders' equity $99,152  $92,745 

see notes to consolidated condensed financial statements

1

UTAH MEDICAL PRODUCTS, INC. AND SUBSIDIARIES
 
CONSOLIDATED CONDENSED STATEMENTS OF INCOME FOR THE 
THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2019 AND SEPTEMBER 30, 2018 
(in thousands, except per share amounts - unaudited) 
  
  THREE MONTHS ENDED  NINE MONTHS ENDED 
  SEPTEMBER 30,  SEPTEMBER 30, 
  2019  2018  2019  2018 
Sales, net $12,494  $10,390  $35,073  $32,242 
                 
Cost of goods sold  5,115   4,096   13,421   12,042 
Gross profit  7,379   6,294   21,652   20,200 
                 
Operating expense                
Selling, general and administrative  2,878   1,784   8,341   5,433 
Research & development  130   108   357   338 
Total operating expense  3,008   1,892   8,698   5,771 
Operating income  4,371   4,402   12,954   14,429 
                 
Other income (expense)  76   79   196   617 
Income before provision for income taxes  4,447   4,481   13,150   15,046 
                 
Provision for income taxes  742   (2,281)  2,781   (116)
Net income $3,705  $6,762  $10,369  $15,162 
                 
Earnings per common share (basic) $1.00  $1.81  $2.79  $4.07 
                 
Earnings per common share (diluted) $0.99  $1.80  $2.77  $4.04 
                 
Shares outstanding - basic  3,720   3,733   3,722   3,730 
                 
Shares outstanding - diluted  3,737   3,753   3,738   3,752 
Other comprehensive income (loss):                
Foreign currency translation net of taxes of $0 in all periods $(1,683) $(385) $(1,200) $(1,920)
Total comprehensive income $2,022  $6,377  $9,169  $13,242 

UTAH MEDICAL PRODUCTS, INC. AND SUBSIDIARIES
 
CONSOLIDATED CONDENSED STATEMENTS OF INCOME FOR THE 
THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2018 AND SEPTEMBER 30, 2017 
(in thousands, except per share amounts - unaudited) 
       
  THREE MONTHS ENDED     NINE MONTHS ENDED    
  SEPTEMBER 30,     SEPTEMBER 30,    
  2018  2017  2018  2017 
Sales, net $10,390  $10,125  $32,242  $31,213 
                 
Cost of goods sold  4,096   3,629   12,042   11,288 
Gross profit  6,294   6,496   20,200   19,925 
                 
Operating expense                
Selling, general and administrative  1,784   1,714   5,433   5,146 
Research & development  108   103   338   341 
Total operating expense  1,892   1,817   5,771   5,487 
Operating income  4,402   4,679   14,429   14,438 
                 
Other income (expense)  79   17   617   65 
Income before provision for income taxes  4,481   4,696   15,046   14,503 
                 
Provision for income taxes  (2,281)  1,074   (116)  3,476 
Net income $6,762  $3,622  $15,162  $11,027 
                 
Earnings per common share (basic) $1.81  $0.97  $4.07  $2.97 
                 
Earnings per common share (diluted) $1.80  $0.97  $4.04  $2.95 
                 
Shares outstanding - basic  3,733   3,719   3,730   3,716 
                 
Shares outstanding - diluted  3,753   3,738   3,752   3,734 
Other comprehensive income (loss):                
Foreign currency translation net of taxes of $0 in all periods $(385) $1,223  $(1,920) $3,559 
Total comprehensive income $6,377  $4,845  $13,242  $14,586 
see notes to consolidated condensed financial statements
2

UTAH MEDICAL PRODUCTS, INC. AND SUBSIDIARIES
 
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS 
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2019 AND SEPTEMBER 30, 2018 
(in thousands - unaudited) 
  
  SEPTEMBER 30, 
  2019  2018 
CASH FLOWS FROM OPERATING ACTIVITIES:      
Net income $10,369  $15,162 
Adjustments to reconcile net income to net cash provided by operating activities:        
Depreciation  526   577 
Amortization  4,512   1,663 
Gain on investments  -   (32)
Provision for (recovery of) losses on accounts receivable  (2)  (1)
Amortization of right of use assets  29     
(Gain) loss on disposal of assets  -   (409)
Deferred income taxes  (398)  (352)
Stock-based compensation expense  85   53 
Tax benefit attributable to exercise of stock options  20   44 
  Changes in operating assets and liabilities:        
Accounts receivable and other receivables  (1,139)  (948)
Inventories  (1,449)  255 
Prepaid expenses and other current assets  73   52 
Accounts payable  (188)  (258)
Accrued expenses  (1,023)  (3,455)
Total adjustments  1,046   (2,811)
Net cash provided by operating activities  11,415   12,351 
         
CASH FLOWS FROM INVESTING ACTIVITIES:        
Capital expenditures for:        
Property and equipment  (252)  (255)
Intangible assets  (21,000)  - 
Purchases of investments  -   - 
Proceeds from sale of:        
Investments  -   74 
Property and equipment  -   862 
Net cash (used in) provided by investing activities  (21,252)  681 
         
CASH FLOWS FROM FINANCING ACTIVITIES:        
Proceeds from issuance of common stock - options  223   436 
Common stock purchased and retired  (398)  - 
Payment of dividends  (3,083)  (3,018)
Net cash used in financing activities  (3,258)  (2,582)
         
Effect of exchange rate changes on cash  (624)  (973)
         
Net increase (decrease) in cash and cash equivalents  (13,719)  9,477 
         
Cash at beginning of period  51,112   39,875 
         
Cash at end of period $37,393  $49,352 
         
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:        
Cash paid during the period for income taxes $3,957  $3,820 
Cash paid during the period for interest  -   - 

see notes to consolidated condensed financial statements
3

UTAH MEDICAL PRODUCTS, INC. 
CONSOLIDATED CONDENSED STATEMENT OF STOCKHOLDERS' EQUITY 
Three and Nine Months Ended September 30, 2019 and 2018 
(In thousands - unaudited) 
  
           Accumulated       
        Additional  Other     Total 
  Common Stock  Paid-in  Comprehensive  Retained  Stockholders' 
  Shares  Amount  Capital  Income  Earnings  Equity 
Balance at June 30, 2019  3,719  $37  $-  $(10,807) $104,682  $93,912 
Shares issued upon exercise of employee stock options for cash  1   -   52   -   -   52 
Stock option compensation expense  -   -   29   -   -   29 
Common stock purchased and retired  -   -   (81)  -   81   - 
Foreign currency translation adjustment  -   -   -   (1,683)  -   (1,683)
Common stock dividends  -   -   -   -   (1,029)  (1,029)
Net income  -   -   -   -   3,705   3,705 
Balance at September 30, 2019  3,720  $37  $-  $(12,490) $107,439  $94,986 
                         
Balance at December 31, 2018  3,720  $37  $121  $(11,290) $100,123  $88,992 
Shares issued upon exercise of employee stock options for cash  5   -   222   -   -   222 
Stock option compensation expense  -   -   85   -   -   85 
Common stock purchased and retired  (5)  -   (429)  -   31   (398)
Foreign currency translation adjustment  -   -   -   (1,200)  -   (1,200)
Common stock dividends  -   -   -   -   (3,084)  (3,084)
Net income  -   -   -   -   10,369   10,369 
Balance at September 30, 2019  3,720  $37  $0  $(12,490) $107,439  $94,986 
                         
Balance at June 30, 2018  3,732  $37  $1,197  $(9,876) $92,004  $83,362 
Shares issued upon exercise of employee stock options for cash  2   -   89   -   -   89 
Stock option compensation expense  -   -   11   -   -   11 
Foreign currency translation adjustment  -   -   -   (385)  -   (385)
Common stock dividends  -   -   -   -   (1,008)  (1,008)
Net income  -   -   -   -   6,762   6,762 
Balance at September 30, 2018  3,734  $37  $1,297  $(10,261) $97,758  $88,831 
                         
Balance at December 31, 2017  3,721  $37  $809  $(8,341) $85,617  $78,122 
Shares issued upon exercise of employee stock options for cash  15   -   661   -   -   661 
Shares received and retired upon exercise of stock options  (2)  -   (225)  -   -   (225)
Stock option compensation expense  -   -   53   -   -   53 
Foreign currency translation adjustment  -   -   -   (1,920)  -   (1,920)
Common stock dividends  -   -   -   -   (3,022)  (3,022)
Net income  -   -   -   -   15,162   15,162 
Balance at September 30, 2018  3,734  $37  $1,297  $(10,261) $97,758  $88,831 

see notes to consolidated condensed financial statements

24

UTAH MEDICAL PRODUCTS, INC. AND SUBSIDIARIES
 
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS 
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2018 AND SEPTEMBER 30, 2017 
(in thousands - unaudited) 
  
  SEPTEMBER 30,    
  2018  2017 
CASH FLOWS FROM OPERATING ACTIVITIES:      
Net income $15,162  $11,027 
Adjustments to reconcile net income to net cash provided by operating activities:        
Depreciation  577   489 
Amortization  1,663   1,568 
(Gain) loss on investments  (32)  - 
Provision for (recovery of) losses on accounts receivable  (1)  (2)
(Gain) loss on disposal of assets  (409)  - 
Deferred income taxes  (352)  (281)
Stock-based compensation expense  53   99 
Tax benefit attributable to exercise of stock options  44   25 
  Changes in operating assets and liabilities:        
Accounts receivable - trade  (948)  (1,340)
Accrued interest and other receivables  0   (5)
Inventories  255   (301)
Prepaid expenses and other current assets  52   40 
Accounts payable  (258)  201 
Accrued expenses  (3,455)  803 
Total adjustments  (2,811)  1,296 
Net cash provided by operating activities  12,351   12,323 
         
CASH FLOWS FROM INVESTING ACTIVITIES:        
Capital expenditures for:        
Property and equipment  (255)  (174)
Intangible assets  -   - 
Purchases of investments  -   - 
Proceeds from sale of:        
Investments  74   - 
Property and equipment  862     
Net cash (used in) provided by investing activities  681   (174)
         
CASH FLOWS FROM FINANCING ACTIVITIES:        
Proceeds from issuance of common stock - options  436   224 
Payment of dividends  (3,018)  (1,969)
Net cash (used in) provided by financing activities  (2,582)  (1,745)
         
Effect of exchange rate changes on cash  (973)  738 
         
Net increase in cash and cash equivalents  9,477   11,142 
         
Cash at beginning of period  39,875   26,296 
         
Cash at end of period $49,352  $37,438 
         
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:        
Cash paid during the period for income taxes $3,820  $3,753 
Cash paid during the period for interest  -   - 
see notes to consolidated condensed financial statements
3

UTAH MEDICAL PRODUCTS, INC.
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
(unaudited)

(1)   The unaudited financial statements have been prepared in accordance with the instructions to Form 10-Q and do not include all of the information and note disclosures required by accounting principles generally accepted in the United States.  These statements should be read in conjunction with the financial statements and notes included in the Utah Medical Products, Inc. ("UTMD" or "the Company") annual report on Form 10‑K for the year ended December 31, 2017.2018.  In the opinion of management, the accompanying financial statements include all adjustments (consisting only of normal recurring adjustments) necessary to summarize fairly the Company's financial position and results of operations.  Currency amounts are in thousands except per-share amounts and where noted.

(2)   Recent Accounting Standards.

In May 2014,February 2016, new accounting guidance (ASU 2014-09) was issued that outlines a single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and supersedes most current revenue recognition guidance, including industry-specific guidance. The guidance is based on the principle that an entity should recognize revenue to depict the transfer of goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services.  The guidance also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to fulfill a contract.  UTMD adopted this new standard on January 1, 2018, using a modified retrospective approach. In accordance with ASU 2014-09, UTMD's revenue recognition is based on standard terms & conditions of sale for like customers in addition to contracts and the performance obligations identified in them. With very insignificant and limited exceptions, the Company's performance obligation is met when it ships a physical product to a customer. The basis on which UTMD recognizes revenue was updated on January 1, 2018, but it did not result in a change to the process and timing of revenue recognition, because the previous revenue recognition method complies with ASU 2014-09.  Therefore, the adoption of ASU 2014-09 did not have an impact on UTMD's financial statements.  In accordance with this adoption disaggregated revenue is presented in Note 7.

In February 2016, new accounting guidance2016-02, Leases (Topic 842)) was issued which requires recording most leases on the balance sheet. The new lease standard requires disclosure of key information about lease arrangements and aligns many of the underlying principles of this new model with those in the new revenue recognition standard noted above.standard. This guidance becomesis effective for annual reporting periods beginning after December 15, 2018, with early adoption permitted.  The new guidance became effective for UTMD has yeton January 1, 2019.  UTMD applied the requirements using the modified retrospective method and so will not restate comparative financial statements.  Implementation of the standard resulted in addition of right of use assets and lease liabilities of $452 to assess the impact that this standardconsolidated condensed balance sheet and will require additional disclosures but will have no effect on the income statement.  UTMD’s only leases are for a portion of the parking lot at the Midvale facility and an automobile in Ireland.

The Company has determined that other recently issued accounting standards will either have no material impact on its consolidated financial statements when it is adopted. The only significant lease the Company anticipates itposition, results of operations or cash flows, or will have at that time is for the parking lot atnot apply to its Utah facility.operations.

(3)   Inventories at September 30, 2018,2019, and December 31, 2017,2018, consisted of the following:
 
 September 30,  December 31,  September 30,  December 31, 
 2018  2017  
2019
  2018 
Finished goods $1,413  $1,313  $2,352  $1,615 
Work‑in‑process  1,106   1,270  1,005  1,103 
Raw materials  2,401   2,661   3,354   2,694 
Total $4,920  $5,244  $6,711  $5,412 

5

(4)Stock-Based Compensation. At September 30, 2018,2019, the Company has stock-based employee compensation plans which authorize the grant of stock options to eligible employees and directors.  The Company accounts for stock compensation under FASB Accounting Standards Codification ("ASC"(“ASC”) 718, Compensation - Stock Compensation.  This statement requires the Company to recognize compensation cost based on the grant date fair value of options granted to employees and directors.  In the quarters ended September 30, 2018,2019, and 2017,2018, the Company recognized $11$29 and $30,$11, respectively, in stock based compensation cost.  In the nine months ended September 30, 2018,2019, and 2017,2018, the Company recognized $35$85 and $99,$53, respectively, in stock based compensation cost.
4


(5)   Warranty Reserve.  The Company'sCompany’s published warranty is: "UTMD“UTMD warrants its products to conform in all material respects to all published product specifications in effect on the date of shipment, and to be free from defects in material and workmanship for a period of thirty (30) days for supplies, or twenty-four (24) months for equipment, from date of shipment.  During the warranty period UTMD shall, at its option, replace any products shown to UTMD's reasonable satisfaction to be defective at no expense to the Purchaser or refund the purchase price."

UTMD maintains a warranty reserve to provide for estimated costs which are likely to occur. The amount of this reserve is adjusted, as required, to reflect its actual experience. Based on its analysis of historical warranty claims and its estimate that existing warranty obligations were immaterial, no warranty reserve was made at December 31, 2017,2018, or September 30, 2018.2019.
6

(6)  Global 3Q 2019 revenues (USD) by product category: 

 (6)   Fair Value Measurements.  The Company follows ASC 820, Fair Value Measurement to determine fair value of its financial assets.  The following table provides financial assets carried at fair value measured as of September 30, 2018:
   Fair Value Measurements Using 
Description
Total Fair Value
at 9/30/2018
 
Quoted Prices
in Active Markets
for Identical Assets
(Level 1)
 
Significant Other
Observable Inputs
(Level 2)
 
Significant
Unobservable Inputs
(Level 3 )
 
Equities $0  $0  $0  $0 
  Domestic  Outside US  Total 
Obstetrics $1,072  $204  $1,276 
Gynecology/Electrosurgery/Urology  3,195   3,199   6,394 
Neonatal  1,228   360   1,588 
Blood Pressure Monitoring and Accessories  2,080   1,156   3,236 
Total $7,575  $4,919  $12,494 

(7)  Global 9M 2019 revenues (USD) by product category:

 Domestic  Outside US  Total  Domestic  Outside US  Total 
Obstetrics $973  $114  $1,087  $3,137  $710  $3,847 
Gynecology/Electrosurgery/Urology  1,806   3,700   5,506  8,503  10,237  18,740 
Neonatal  1,138   464   1,602  3,545  988  4,533 
Blood Pressure Monitoring and Accessories  1,352   843   2,195   5,181   2,772   7,953 
Total $5,269  $5,121  $10,390  $20,366  $14,707  $35,073 

(7)  Leases

UTMD has operating leases for a portion of its parking lot at its Midvale facility and an automobile at its Ireland facility.  The remaining lease term on the parking lot is 12 years and on the automobile is 28 months.  There are no options to extend or terminate the leases.  UTMD has no other leases yet to commence.  As neither lease contains implicit rates, UTMD’s incremental borrowing rate, based on information available at adoption date, was used to determine the present value of the leases.

The components of lease cost were as follows:
Three Months
Ended
September 30,
2019
 
Operating Lease Cost (in thousands)
$15 
Right of Use Assets obtained in exchange for new operating lease Obligations$0 
    
Other Information
Three Months
Ended
September 30,
2019
 
Weighted Average Remaining Lease Term - Operating Leases12 years 
Weighted Average Discount Rate – Operating Leases 5.4%

Operating lease liabilities/ payments (in thousands)
   
Operating lease payments, 2019 $15 
Operating lease payments, 2020 $60 
Operating lease payments, 2021 $60 
Operating lease payments, 2022 $45 
Operating lease payments, 2023 $45 
Thereafter $344 

Reconciliation of operating lease liabilities/ payments to operating lease liabilities 
(in thousands)
 
Total operating lease liabilities/ payments $569 
Operating lease liabilities – current (included in Accrued Expenses)  37 
Operating lease liabilities – long term  385 
Present value adjustment $147 

Maturities of lease liabilities were as follows: 
(in thousands)
 
     
Year ending December 31,    
2019 $37 
2020 $38 
2021 $40 
2022 $27 
2023 $29 
Thereafter $280 

7

(8)  Distribution Agreement Purchase. UTMD completed the purchase of exclusive U.S. distribution rights for the FILSHIE Clip System from CooperSurgical, Inc. (CSI) on February 1, 2019, after which CSI will no longer sell the FILSHIE Clip System and UTMD will distribute the FILSHIE Clip System directly to clinical facilities in the U.S. The $21,000 purchase price represents an identifiable intangible asset which will be straight-line amortized and recognized as part of G&A expenses over the 4.75 year remaining life of the prior CSI distribution agreement with Femcare.  As part of the agreement, UTMD also purchased the remaining CSI inventory for approximately $2,100.

(9) Earnings Per Share. Basic earnings per share is calculated by dividing net income attributable to the common stockholders of the company by the weighted average number of common shares outstanding during the period.  Diluted earnings per share is calculated by assuming the exercise of stock options at the closing price of stock at the end of 3rd quarter 2019.

The following table reconciles the numerator and the denominator used to calculate basic and diluted earnings per share:

(in thousands) Three months ended  Nine months ended 
  September 30,  September 30, 
  2019  2018  2019  2018 
Numerator            
Net income  3,705   6,762   10,369   15,162 
                 
Denominator                
Weighted average shares, basic  3,720   3,733   3,722   3,730 
Dilutive effect of stock options  17   20   16   22 
Diluted shares  3,737   3,753   3,738   3,752 
                 
Earnings per share, basic  1.00   1.81   2.79   4.07 
Earnings per share, diluted  .99   1.80   2.77   4.04 

(10)Subsequent Events.  UTMD has evaluated subsequent events through the date the financial statements were issued, and concluded there were no other events or transactions during this period that required recognition or disclosure in its financial statements.

58


Item 2.  Management's Discussion and Analysis of Financial Condition and Results of Operations

General

Utah Medical Products, Inc. (UTMD) manufactures and markets a well-established range of specialty medical devices.  The Company'sCompany’s Form 10-K Annual Report for the year ended December 31, 2017,2018, provides a detailed description of products, technologies, markets, regulatory issues, business initiatives, resources and business risks, among other details, and should be read in conjunction with this report.  Because of the relatively short span of time, results for any given three month period in comparison with a previous three month period may not be indicative of comparative results for the year as a whole.  Currency amounts in the report are in thousands, except per share amounts or where otherwise noted.  Currencies in this report are denoted as $ or USD = U.S. Dollars; A$ or AUD = Australia Dollars; £ or GBP = UK Pound Sterling; C$ or CAD = Canadian Dollars; and € or EUR = Euros.

Analysis of Results of Operations

a) Overview
In the third calendar quarter (3Q) and first nine months (9M) of 2018,2019, UTMD achievedattained results which conformreflect that the Company is likely to exceed its overall revenue growth goal, but fall somewhat short of its gross profit and therefore bottom line goal for the calendar year as a whole.

A comparison of 3Q and 9M 2019 results with the Company's previously announced goals for 2018.

Financial results in 3Q and 9Mthe same periods of 2018, according to U.S. Generally Accepted Accounting Principles (GAAP)(US GAAP), wereare masked by athe 3Q 2018 favorable adjustment to UTMD'sUTMD’s initial provisional estimate of its "one time"“one time” U.S. repatriation (REPAT) tax liability resulting from the "Tax“Tax Cuts and Jobs Act"Act” (TCJA) enacted in December 2017.  UTMD'sUTMD’s initial estimate of the combined Federal and Utah State REPAT tax was $6,288, recorded in 4Q 2017 financial results, the period in which the TCJA was enacted by Congress.  In 3Q 2018, after more IRS information became available and when UTMD'sUTMD’s independent tax advisors completed the 2017 income tax return, it became known to the Company that the actual REPAT tax liability iswas $3,058, resulting in a favorable $3,230 adjustment to UTMD'sUTMD’s 3Q 2018 income tax provision. In addition, there is a new Global Intangible Low-Taxed Income (GILTI) tax applicable for 2018 that resulted from the TCJA, an estimate for which is included in the 3Q 2018 tax provision for the first time. All income statement categories of UTMD's operating performance are unaffected by theThe REPAT tax adjustment and GILTI tax estimate except forin 3Q 2018 only affects  the comparison in Net Income, (NI), profits after tax, and Earnings Per Share (EPS).

UTMD management believes that the presentation of results excluding the favorable REPAT tax liability adjustment and the new 2018 GILTI tax, to its 3Q 2018 and 9M 2018 income tax provision provides meaningful supplemental information to both management and investors that is more clearly indicative of UTMD'sUTMD’s operating results in 20182019 compared to 2017.  For clarity, there is no difference in the GAAP and non-GAAP income statement numbers except for NI and EPS.2018.

Income statement results in 3Q and 9M 20182019 compared to the same periods of 20172018 were as follows:

 3Q 2018  3Q 2017  change   9M 2018   9M 2017  change  3Q 2019  3Q 2018  change   9M 2019   9M 2018  change 
Net Sales $10,390  $10,125   +2.6% $32,242  $31,213   +3.3% $12,494  $10,390  +20.2% $35,073  $32,242  + 8.8%
Gross Profit  6,294   6,496   (3.1%)  20,200   19,925   +1.4% 7,379  6,294  +17.2% 21,652  20,200  + 7.2%
Operating Income  4,402   4,679   (5.9%)  14,429   14,438   (0.1%) 4,371  4,402  ( 0.7%) 12,954  14,429  (10.2%)
Income Before Tax  4,481   4,696   (4.6%)  15,046   14,503   +3.7%  4,448   4,481   ( 0.7%)  13,150   15,046   (12.6%)
NI Before REPAT Tax Adjust  3,582   3,622   (1.1%)  11,982   11,027   +8.7% 3,705  3,582  + 3.4% 10,369  11,982  (13.5%)
Net Income (NI)  6,762   3,622   +86.7%  15,162   11,027   +37.5%  3,705   6,762   (45.2%)  10,369   15,162   (31.6%)
EPS Before REPAT Tax Adjust  0.954   0.969   (1.5%)  3.194   2.953   +8.1% 0.991  0.954  + 3.9% 2.774  3.194  (13.1%)
Earnings per Diluted Share (EPS)  1.802   0.969   +85.9%  4.041   2.953   +36.8% 0.991  1.802  (45.0%) 2.774  4.041  (31.4%)

OppositeFinancial results in 3Q 2019 continued to first half (1H) 2018, UTMD's relative 3Q 2018 sales performance was reducedbe hampered on the top line by a stronger USD.  RevenuesUSD, although to a lesser degree than in the first six months of the year.  The improvement in 3Q 2019 Sales was essentially due to a conversion from selling the Filshie Clip System to a third-party distributor in the U.S. in 2018 would have been $76 higher usingto selling directly to U.S. medical facilities in 3Q 2019, and an increase in U.S. OEM sales. OEM sales are sales of components or finished products, which may not be medical devices, to other companies for inclusion in their products.

Because 23.6% of 3Q 2019 consolidated Sales and 27.2% of 9M 2019 consolidated Sales were in foreign currencies, the samevolatility of foreign currency exchange (FX) rates asfor sales and expenses outside the U.S. (OUS) continued to have an impact on period-to-period relative financial results. UTMD’s 3Q 2018 and 9M 2018 revenues invoiced in the prior year ("constant currency").  However, becauseforeign currencies represented 33.3% and 32.6% of the weakertotal consolidated USD in 1H 2018, revenues in 9M 2018 would have been $443 lower in constant currency. The FX rate change represented 43% of the 9M 2018 sales increase relative to 9M 2017. UTMD's respectively.

FX rates for income statement purposes are transaction-weighted averages. The average rates from the applicable foreign currency to USD during 3Q 20182019 and 9M 20182019 compared to the same periods in 20172018 follow:

  3Q 18   3Q 17  Change   9M 18   9M 17  Change   3Q 19   3Q 18  change   9M 19   9M 18  change 
GBP  1.304   1.312   (0.6%)  1.351   1.277   +5.7% 1.233  1.304  (5.5%) 1.273  1.351  (5.7%)
EUR  1.165   1.172   (0.6%)  1.193   1.116   +7.0% 1.108  1.165  (4.9%) 1.123  1.193  (5.9%)
AUD  0.732   0.789   (7.2%)  0.758   0.766   (1.1%) 0.687  0.732  (6.1%) 0.700  0.758  (7.6%)
CAD  0.765   0.800   (4.3%)  0.778   0.764   +1.8% 0.758  0.765  (1.0%) 0.752  0.778  (3.3%)

69

UTMD's revenues invoicedThe weighted average negative impact on all foreign currency sales from the change in the above foreign currencies represented 32.2% of total consolidatedFX rates was 5.2% in 3Q 2019 and 5.7% in 9M 2019, reducing reported USD sales in 3Q 2019 by $145 relative to the same FX rates in 3Q 2018 and 32.6%by $576 in 9M 2019 relative to the same FX rates in 9M 2018.  In constant currency terms, i.e. using the same FX rates as in the applicable periods in 2018, total consolidated 3Q 2019 sales were up $2,248 (+21.6%), and 9M 2019 total consolidated constant currency sales were up $3,407 (10.6%).

Other significant revenue changes in 3Q and 9M 2019 as compared to the same periods in 2018 are described later in this report: a substantial increase in 2019 U.S. OEM sales; an early shipment, at the China distributor’s request, of a scheduled 4Q 2019 blood pressure transducer kit order; and a continued pause in U.S. neonatal device exports due to regulatory re-registrations by UTMD’s third-party distributor in China.

UTMD US GAAP profit margins in 3Q 2019 and 9M 2019 compared to 3Q 2018 and 9M 2018 follow:

 
3Q 2019
(Jul – Sep)
3Q  2018
(Jul – Sep)
9M  2019
(Jan – Sep)
9M  2018
(Jan – Sep)
Gross Profit Margin (gross profits/ sales):59.1%60.6%61.7%62.7%
Operating Income Margin (operating profits/ sales):35.0%42.4%36.9%44.8%
Net Income Margin (profit after taxes/ sales):29.7%65.1%29.6%47.0%

Excluding the 3Q 2018 REPAT tax provision adjustment, the resulting non-GAAP Net Income Margin follows:

 
3Q 2019
(Jul – Sep)
3Q  2018
(Jul – Sep)
9M  2019
(Jan – Sep)
9M  2018
(Jan – Sep)
Net Income Margin (profit after taxes/ sales):29.7%34.5%29.6%37.2%

UTMD’s 2019 Gross Profit increase was due to the U.S. direct sales of the Filshie Clip System (Filshie devices), which was offset on the Operating Income line by new identifiable intangible asset (IIA) amortization expense resulting from UTMD’s February 2019 purchase of the remaining U.S. exclusive distribution rights from CooperSurgical Inc (CSI).

The 2019 dilution in Gross Profit Margin (GPM) was due to product mix, more specifically, much higher (lower than average GPM) OEM sales along with substantially higher low GPM sales of pressure transducer kits to UTMD’s China distributor as a result of the distributor’s uneven requested shipment pattern.  As UTMD stockholders likely already understand, the GPM obtained from OEM sales of products manufactured by UTMD for other companies, and of UTMD finished medical devices sold through third-party distributors, are inherently lower because the costs of marketing the products reside with UTMD’s customer.  Primarily because of the mix shift, UTMD now expects that its GPM for the year as a whole may be three percentage points lower than projected at the beginning of the year.

UTMD’s 2019 GPM has not yet benefited from the early 2019 acquisition of distribution rights of its Filshie devices in the U.S. from CSI because of the substantial remaining inventory which was repurchased by UTMD at CSI’s cost.  Although UTMD has picked up the distributor margin on higher U.S. Filshie device direct sales, it has not realized any Gross Profit contribution from Femcare sales of Filshie devices to the U.S. yet. Another way to explain this is that approximately $2 million in UTMD’s consolidated Gross Profit was recorded in 9M 2018 from Femcare’s 9M 2018 sales of Filshie devices to the third-party U.S. distributor, whereas Femcare’s Gross Profit contribution from sales of Filshie devices to the U.S. (to intercompany distributor UTMD) has been zero in 9M 2019 because the Gross Profit in inventory from intercompany sales is eliminated when consolidating financial results (i.e. not recognized until the devices are sold to a third-party).  The fact that the CSI repurchased inventory lasted longer than expected has helped lower GPM results relative to the increase expected at the beginning of the year.

UTMD’s Operating Income Margin was diluted further (in addition to the lower GPM) by a $1,105 3Q 2019 expense, and in 9M 2019 by a $2,947 expense, from straight-line amortization of the $21,000 purchase price that UTMD paid CSI to acquire the remaining 4.75 years’ exclusive U.S. Filshie device distribution rights because the purchase price of CSI’s remaining exclusive distribution rights was recognized as an IIA. UTMD’s Operating Income Margin from the acquisition is expected to ramp up as a result of an estimated additional $500 Gross Profit which will be achieved quarterly at the same Filshie device sales rate as 3Q 2019 after the CSI inventory has been depleted, disregarding UTMD’s potential to grow Filshie device sales in the U.S.

Femcare-related IIA amortization expense in total, including the CSI distribution agreement purchase and that remaining from the 2011 Femcare Group acquisition, comprises a significant portion of General & Administrative (G&A) operating expenses.  IIA amortization expense was 12.8% of 3Q 2019 consolidated sales and 12.7% of 9M 2019 consolidated sales compared to 5.0% in both 3Q 2018 and 9M 2018.  In other words, UTMD’s Operating Income Margin excluding Femcare-related IIA amortization expense was consistent at 47.8% in 3Q 2019 and 49.7% in 9M 2019 compared to 47.4% in 3Q 2018 and 49.8% in 9M 2018.
10

In addition to the period-to-period differences in Operating Income, an additional difference in Income Before Tax (EBT) was due to the $450 Non-operating Income from the sale of unneeded assets in 9M 2018 that did not repeat in 9M 2019.  Net Non-operating Income was $76 in 3Q 2019 compared to $79 in 3Q 2018, and $180 in 9M 2019 compared to $617 in 9M 2018.

Although salesUTMD’s US GAAP Net Income Margins in 3Q and 9M 2019 were highersubstantially lower than expected, UTMD realized pressure on its operating profit marginsin the same periods of 2018 because of the $3,230 favorable adjustment to UTMD’s initial estimate of the combined one-time Federal and Utah State REPAT tax which occurred in 3Q 2018.

The associated key profit margins (profits as a percentage of sales)UTMD’s 2019 US GAAP EPS compared to the same timeprior year’s 3Q and 9M periods were slightly less unfavorable than the change in US GAAP Net Income, and UTMD’s non-GAAP EPS comparison was slightly more favorable than the change in non-GAAP Net Income, because diluted shares in both periods were slightly lower.

UTMD’s September 30, 2019 Balance Sheet, in the prior calendar yearabsence of debt, remained strong.  Ending Cash and Investments were as follows:
   3Q18   3Q17   9M18   9M17 
Gross Profit Margin (GPM):  60.6%  64.2%  62.7%  63.8%
Operating Income Margin (OIM):  42.4%  46.2%  44.8%  46.3%
 Earnings Before Tax Margin (EBTM):  43.1%  46.4%  46.7%  46.5%
 Net Income Margin (NIM):  65.1%  35.8%  47.0%  35.3%
NIM (non-GAAP):  34.5%  35.8%  37.2%  35.3%

UTMD's consolidated 9M 2018 GPM was squeezed primarily due to higher direct materials costs combined with lack of price increases to customers. Direct labor productivity was consistent with the prior year.  Consolidated Operating Expenses (OE) were $284 higher in 9M 2018$37.4 million on September 30, 2019 compared to 9M 2017. OE are comprised of general and administrative (G&A), sales and marketing (S&M) and product development (R&D) expenses. Sixty-one percent of the increase in total OE came from the UK subsidiary G&A. Included in G&A expenses, the UK amortization of IIA was the same in GBP in 9M 2018 as in 9M 2017, but $91 higher because of USD/GBP FX rates. Remaining 9M 2018 UK G&A expenses were $81 higher than in 9M 2017 even though expenses were just GBP 39 higher. The remaining higher OE  was due to higher worldwide S&M expenses, which were $137 higher with very little impact due to FX rates. U.S. S&M expenses were $85 higher in 9M 2018 than in 9M 2017, and OUS S&M expense were $52 higher, as a result of adding additional people and increasing trade show attendance.  The combination of a lower GPM and higher OE resulted in Operating Income (OI) about the same in 9M 2018 as in 9M 2017 despite 3% higher sales.

The 37% higher Net Income (NI) in 9M 2018 was a result of a favorable $3,230 REPAT tax adjustment less a $50 GILTI tax provision accrual and $551 higher non-operating income (NOI) compared to 9M 2017.  Excluding the REPAT tax adjustment and GILTI tax accrual, non-GAAP NI was $955 (+8.7%) higher in 9M 2018 than in 9M 2017 due to the higher NOI and an average consolidated income tax rate in 9M 2018 3.6 percentage points lower than in 9M 2017 due to the TCJA.  For the same reasons as NI, Earnings Per Diluted Share (EPS) in 9M 2018 were up 37%.  Non-GAAP EPS, excluding the REPAT tax adjustment and GILTI tax accrual, was $0.241 (+8.1%) higher in 9M 2018 than in 9M 2017.  EPS for the most recent twelve months (TTM), which included a $6,288 4Q 2017 REPAT tax accrual and the ($3,230) 3Q 2018 REPAT tax accrual adjustment were $3.37.  TTM non-GAAP EPS were $4.14.

UTMD's September 30, 2018 balance sheet compared with its$51.1 million on December 31, 2017 balance sheet demonstrates continued strengthening. Working capital increased $10,377 in 9M 2018. Capital expenditures for property2018, after investing $23.1 million acquiring CSI’s Filshie device distribution rights and equipment were $255 in 9M 2018, compared to depreciation expense of $577. In 9M 2018 UTMD distributed $3,018remaining inventory, paying $3.1 million in cash dividends to its stockholders.stockholders and repurchasing $0.4 million in UTMD stock during 9M 2019.  Stockholders’ Equity was up $6.0 million in the nine month period from December 31, 2018, after netting the combined $3.5 million in dividends and stock repurchases which reduced Stockholders’ Equity.

UTMD'sUTMD’s FX rates for balance sheet purposes are the applicable rates at the end of each reporting period. The FX rates from the applicable foreign currency to USD for assets and liabilities at the end of September 20182019 and the end of September 20172018 follow:

 
September 30,
2018
  
September 30,
2017
  Change  Sep 30, 2019  Sep 30, 2018  Change 
GBP  1.306   1.340   (2.6%) 1.230  1.306  ( 5.8%)
EUR  1.163   1.181   (1.6%) 1.091  1.163  ( 6.2%)
AUD  0.724   0.784   (7.7%) 0.675  0.724  ( 6.8%)
CAD  0.774   0.799   (3.2%) 0.755  0.774  ( 2.4%)

b)Revenues

Beginning on January 1, 2018, the Company adopted ASU 2014-09, the new revenue recognition accounting standard.  Management completed an extensive assessment and implementation of the standard, including UTMD'sUTMD’s various contracts with customers and associated performance obligations and the Company'sCompany’s conclusions regarding its revenue recognition practices and procedures. Other items like commissions and rights of return were also evaluated by the Company. Management is confident that the Company has properly evaluated the standard'sstandard’s requirements and has arrived at appropriate conclusions in recognizing revenue in accordance with the new standard.  Those practices and procedures the Company will use to recognize revenue under the new standard are not significantly different than the methods used previously since UTMD has traditionally recognized revenue upon shipping a physical product to a customer, which is also when the Company has met its performance obligations under contracts it has with its customers that represent over 99% of its revenue. While the Company'sCompany’s revenue not associated with shipping a physical product is immaterial, management believes the Company'sCompany’s practices in recognizing that revenue is also in accordance with ASU 2014-09.
7


Terms of sale are established in advance of UTMD'sUTMD’s acceptance of customer orders.  In the U.S., Ireland, UK, France, Canada and Australia, prior to 2017, UTMD generally acceptedaccepts orders directly from and shippedships directly to end user clinical facilities, as well as third party medical/surgical distributors, under UTMD'sUTMD’s Standard Terms and Conditions (T&C) of Sale. The same was true in 2017 with the addition of direct shipments to end user facilities in Canada and France. About 14% of UTMD'sUTMD’s domestic end user sales, excluding Femcare's Filshie Clip Systemdevice sales, to its exclusive U.S. distributor, CooperSurgical Inc. (CSI), go through third party med/surg distributors which contract separately with clinical facilities to provide purchasing, storage and scheduled delivery functions for the applicable facility.  UTMD'sUTMD’s T&C of Sale to end user facilities are substantially the same in the U.S., Canada, Ireland, UK, France, Canada and Australia.

UTMD may have separate discounted pricing agreements with a specific clinical facility or group of affiliated facilities based on volume of purchases.  Pricing agreements which are documented arrangements with clinical facilities, or groups of affiliated facilities, if applicable, are established in advance of orders accepted or shipments made. For existing customers, past actual shipment volumes typically determine the fixed price by part number for the next agreement period of one year. For new customers, the customer'scustomer’s best estimate of volume is usually accepted by UTMD for determining the ensuing fixed prices for the agreement period. Prices are not adjusted after an order is accepted. For the sake of clarity, the separate pricing agreements with clinical facilities based on volume of purchases disclosure is not inconsistent with UTMD'sUTMD’s disclosure that the selling price is fixed prior to the acceptance of a specific customer order.

11

Total consolidated 3Q 2018 consolidated2019 UTMD sales were $265$2,104 (+2.6%20.2%) higher than in 3Q 2017, despite a negative FX impact of ($76).2018. Constant currency sales were $2,248 (+21.6%) higher. Total consolidated 9M 20182019 UTMD sales were $1,029$2,831 (+3.3%8.8%) higher than in 9M 2017, and2018.  Constant currency sales in 9M 2019 were helped by a favorable FX impact of +$443.  Comparing$3,407 (+10.6%) higher than in 9M 2018.

In 3Q 20182019 compared to 3Q 2017, total2018, U.S. domestic sales were 7%44% higher and USD sales outside the U.S. (OUS sales)(OUS) sales were 2%4% lower.  Eighty-four percentBecause of the relatively short span of time, results for any given three month period in comparison with a previous three month period may not be indicative of comparative results for the year as a whole.  In 9M 2019 compared to 9M 2018, U.S. domestic sales were 27% higher and outside the U.S. (OUS) sales were 9% lower than in 9M 2018.

Domestic sales in 3Q 2019 were $7,575 compared to $5,270 in 3Q 2018.  Domestic sales in 9M 2019 were $20,366 compared to $16,005 in 9M 2018.  The components of domestic sales include 1) “direct sales” of UTMD’s medical devices to user facilities (and med/surg stocking distributors for hospitals), excluding Filshie sales,  2) “OEM sales” of components and other products manufactured by UTMD for other medical device and non-medical device companies, and  3) Filshie device sales, which in 2018 were by UTMD’s UK subsidiary, Femcare Ltd (Femcare), to CSI for distribution in the U.S., and in 2019 were by UTMD direct to U.S. clinical users after February 1.  Domestic direct sales in 3Q 2019 excluding Filshie devices, representing 48% of total domestic sales, were $76 (2%) lower than in 3Q 2018.  This was a good example of “results for any given three month period in comparison with a previous three month period may not be indicative of comparative results for the year as a whole” because domestic direct sales in 9M 2019 excluding Filshie devices, representing 53% of total domestic sales, were $441 (+4%) higher than in 9M 2018. OEM sales in 3Q 2019, representing 25% of total domestic sales, were $877 (+83%) higher than in 3Q 2018. OEM sales in 9M 2019, representing 23% of total domestic sales, were $1,848 (+64%) higher than in 9M 2018.  As expected, Filshie device sales direct to U.S. domestic end-user facilities were $1,504 (+299%) higher in 3Q 2019 compared to Filshie device sales to CSI in 3Q 2018.  As previously reported, UTMD expects that 4Q 2019 U.S. Filshie device sales will also experience a similar 300% increase when compared to 4Q 2018 sales to CSI. Filshie device sales direct to U.S. domestic end-user facilities were $2,072 (+73%) higher in 9M 2019 compared to Filshie device sales to CSI in 9M 2018.

OUS sales in 3Q 2019 were $4,919 compared to $5,121 in 3Q 2018. OUS sales in 9M 2019 were $14,707 compared to $16,237 in 9M 2018. OUS sales invoiced in GBP, EUR, AUD and CAD currencies were $145 lower in 3Q 2019 and $576 lower in 9M 2019 as a result of changes in FX rates.  In other words, 72% of the lower 3Q 20182019 OUS sales and 38% of the lower 9M 2019 OUS sales were due to FX rate differences. Comparing 9M 2018 to 9M 2017, total U.S. domestic sales were 4% higher anda stronger USD. The foreign currency OUS sales in 3Q 2019 were 3% higher. Ninety-eight percent$2,944, which was 60% of the higher 9M 2018all OUS sales were due to FX rate differences.

U.S. domestic sales were $356 (+7.2%) higher in 3Q 2018 than in 3Q 2017, and $577 (+3.7%) higher in 9M 2018 than in 9M 2017.  Domestic sales were 51%24% of total consolidated sales in 3Q 2018 compared to 49% in 3Q 2017, and 50% in 9M 2018 compared to 49% in 9M 2017. Sales of Femcare's Filshie Clip System to CooperSurgical Inc. (CSI) for distribution in the U.S. were $156 (23.6%) lower in 3Q 2018 compared to 3Q 2017, and $194 (6.4%) lower in 9M 2018 compared to 9M 2017.  Femcare's sales to CSI were 10% of total domestic sales in 3Q 2018 compared to 13% in 3Q 2017, and 18% in 9M 2018 compared to 20% in 9M 2017. Domestic OEM sales were $224 (+27.1%) higher in 3Q 2018 compared to 3Q 2017, and $548 (+23.4%) higher in 9M 2018 compared to 9M 2017. Direct sales to U.S. user facilities were $287 (+8.4%) higher in 3Q 2018 compared to 3Q 2017, and $223 (+2.2%) higher in 9M 2018 compared to 9M 2017.

OUS sales consolidated in USD in 3Q 2018 were $91 (1.7%) lower than in 3Q 2017, and $452 (+2.9%) higher in 9M 2018 than in 9M 2017. Constantsales.  In comparison, foreign currency OUS sales were 0.3% lower in 3Q 2018 than in 3Q 2017, and 0.1%  higher in 9M 2018 compared to 9M 2017. Trade sales are sales to third parties, excluding sales from one UTMD entity to another (intercompany sales). UK subsidiary USD-denominated OUS trade sales, including direct sales to France clinical facilities, were 26% of total OUS sales in 3Q 2018 compared to 25%were $3,454, which was 67% of all OUS sales and 33% of total consolidated sales.

The foreign currency OUS sales in 3Q 2017,9M 2019 were $9,534, which was 65% of all OUS sales and 27% of total consolidated sales.  In comparison, foreign currency OUS sales in 9M 2018 compared to 24%were $10,497, which was 65% of all OUS sales and 33% of total consolidated sales.  The $576 negative impact of a stronger USD in 9M 2017. Included2019 explains 38% of the lower OUS sales.  Lower U.S. export sales of neonatal devices to its China distributor (invoiced in USD) were $579 lower, explaining another 38%.  The remaining 24% was due predominantly to lower Filshie device sales in Canada.

UTMD segments sales into the Femcare UK sales were the direct sales to end users in France which comprised 7% of OUSfollowing general product categories:  gynecology, labor & delivery, neonatal, and miscellaneous including blood pressure monitoring kits and accessories as well as related OEM products.  Worldwide sales in both 3Q 20182019 and 3Q 2017, and 8%9M 2019 were up in all product categories except neonatal.  In 9M 2018 compared to 6% in 9M 2017.  Australia subsidiary USD2019, worldwide gynecology device sales were 9% of total OUS sales in 3Q 2018 compared to 11% in 3Q 2017, and 9% in 9M 2018 compared to 11% in 9M 2017.  Ireland subsidiary USD tradeup 5%, worldwide labor & delivery device sales were 29% of total OUS sales in 3Q 2018 compared to 26% in 3Q 2017, and 25% in both 9M 2018 and 9M 2017. Canada subsidiary USDup 18%, worldwide neonatal device sales were 11% of total OUSdown 15% and worldwide blood pressure monitoring and related OEM product sales in 3Q 2018 compared to 13% in 3Q 2017, and 12% in 9M 2018 compared to 14% in 9M 2017.were up 35%.

The following table provides USD sales amounts divided into general product categories for total sales and the subset of OUS sales:

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Global 3Q 2019 revenues (USD) by product category:

 3Q 2018  3Q 2017   9M 2018   9M 2017  Domestic  Outside US  Total 
Obstetrics $1,087  $1,218  $3,268  $3,372  $1,072  $204  $1,276 
Gynecology/ Electrosurgery/ Urology  5,506   5,529   17,781   17,473 
Gynecology/Electrosurgery/Urology  3,195   3,199   6,394 
Neonatal  1,602   1,510   5,047   4,574   1,228   360   1,588 
Blood Pressure Monitoring and Accessories*  2,195   1,868   6,146   5,794   2,080   1,156   3,236 
Total: $10,390  $10,125  $32,242  $31,213  $7,575  $4,919  $12,494 


8


OUSGlobal 9M 2019 revenues (USD) by product category:

 3Q 2018  3Q 2017   9M 2018   9M 2017  Domestic  Outside US  Total 
Obstetrics $114  $172  $527  $533  $3,137  $710  $3,847 
Gynecology/ Electrosurgery/ Urology  3,700   3,691   11,302   10,966 
Gynecology/Electrosurgery/Urology  8,503   10,237   18,740 
Neonatal  464   543   1,913   1,540   3,545   988   4,533 
Blood Pressure Monitoring and Accessories*  843   805   2,495   2,746   5,181   2,772   7,953 
Total: $5,121  $5,211  $16,237  $15,785 
Total $20,366  $14,707  $35,073 
*includes molded components sold to OEM customers.

Looking forward, sales in 4Q 20182019 are expected to be lowerabout 20% higher than in 4Q 20172018 from two mainthree primary sources, which are both relatedsimilar to the timing of shipmentschanges realized in 3Q 2019 compared to a third party distributor:3Q 2018:

1)UTMD's China
Variation in OUS distributor fororder pattern.  In 4Q 2019, UTMD’s Ireland subsidiary will ship $233 in BPM kits has in the past typically purchased about $400 per shipment, representing about a three month supply. At the distributor's request, there were five such shipments in 2017 totaling $1,964. There have been three shipments in 9M 2018 totaling $1,248, with nothing additional scheduled for 4Q 2018. The resulting lower salesto UTMD’s China distributor.  Shipments to this distributor were nil in 4Q 2018 compared to 4Q 2017 is $425.  This distributor's annual blanket order for 2019 for $1,699, which has been received, is scheduled for four shipments.2018.

2)CSI, Femcare's U.S. distributor for the
Conversion to direct sales of Filshie Clip System, per the Distribution Agreement, receives six shipments per year - typically two shipments per calendar quarterdevices in the first half of the year, and one shipment per quarterU.S. UTMD expects to realize approximately $1,500  higher direct domestic U.S. Filshie device sales in the second half of the year. There have been five shipments in 9M 2018 totaling $2,8404Q 2019 compared to $3,033 in 9M 2017. The finalshipments that Femcare made to its distributor CSI shipment scheduled in 4Q 2018 is about $272 lower2018.
3)
Continued growth in OEM sales.  UTMD expects to ship approximately $600 more in pressure transducer kits and accessories to its largest OEM customer than occurred in 4Q 2017.  As a result, total Femcare shipments to CSI in 2018 compared to 2017 are expected to be $465 (12%) lower than in 2017.  Sales to CSI in 2017 compared to 2016 were 28% higher than in 2016.2018.

As sales to these two distributors are in fixed USD, fluctuations in FX rates do not affect the revenue numbers. Although UTMD considers the lower 4Q 2018 compared to 4Q 2017 sales to these distributors to represent quarterly order pattern fluctuations, not a trend, management does not believe that UTMD will make up the almost $700 lower 4Q 2018 sales from growth in other areas because of a likely negative change in average 4Q 2018 FX rates compared to 4Q 2017. Comparing the (above) September 30, 2018 FX rates used for balance sheet purposes with the (above) weighted-average FX rates for the 3Q 2018 income statement revenues and expenses, indicates a recent trend in declining value of foreign currencies relative to the USD.  The trend did continue in October 2018.    Although management typically does not try to project changes in FX rates, which it considers to be futile, since about one-third of total consolidated revenues are invoicedUTMD does not expect a stronger USD in foreign currencies, there could be a negative FX impact on same4Q 2019 that will reduce its foreign currency sales relative to 4Q 2017 as much as another $100.  There is an additional 4Q FX rate negative impact risk that foreign distributorsin USD terms more than the $145 which purchase UTMD productsoccurred in USDs (roughly one-sixth of total consolidated sales) might delay purchases to3Q 2019 if they think the USD will weaken later, and they have sufficient inventory to support that gamble.

Despite the anticipated lower 4Q 2018 sales compared to 3Q 2018. If the above 4Q 2017,2019 projected revenue changes become true and other sales remain consistent as expected, UTMD expects to meet orwill exceed its 9-10% beginning of year projection of flat salesprojected increase in revenues for the 20182019 year as a whole.

c) Gross Profit (GP)

GP is revenues (sales) minusGross Profit results from subtracting the costcosts of manufacturing (CGS) or purchase price of(or purchasing finished devices for resale. CGS is comprised of direct labor (DL), direct materials (DM)resale) and manufacturing overhead (MOH).  UTMD'sshipping products to customers, from revenues. UTMD’s consolidated GPGross Profit in 3Q 2019 was $1,085 (+17.2%) higher than in 3Q 2018, was $203 lower than in 3Q 2017, while sales were $26520.2% higher. UTMD'sUTMD’s 9M 20182019 GP was only $275$1,452 (+7.2%) higher than in 9M 2017,2018, while sales were $1,029 higher. This GPup 8.8%. When Gross Profits do not rise as fast as sales, the result is GPM dilution.  The 3Q 2019 GPM dilution obviously resultedoccurred primarily because of the faster than average growth in lower margin U.S. OEM sales (+83% compared to +20% overall growth in sales) and a period including double shipments to UTMD’s China distributor at even lower GPMs.

Until the Filshie device inventory purchased from lower GPMs (GP divided by sales) as shownCSI is depleted, the Gross Profit on sales of Filshie Clip System devices in the table above.U.S. is UTMD’s direct end user price minus the former distributor’s (CSI’s) purchase price of the inventory, i.e. a distributor margin.  The $1,085 higher Gross Profit in 3Q 2019 was due to the higher Filshie device sales in the U.S. at the distributor margin, which practically offset the $1,105 IIA amortization expense resulting from the purchase of CSI’s U.S. exclusive distribution rights, which was the basic plan.

DM expense represented 53.6%With respect to all UTMD manufactured devices, to date in 2019 the company has been able to maintain the productivity of CGS in 3Q 2018 compared to 50.3% of CGS in 3Q 2017. The 3Q 2017 GPM was helped by a favorable $80 adjustment in UTMD's U.S. health plan reserve (representing about 0.8 GPM percentage points for the quarter) due to better than expected employee medical cost experience, which did not recur in 3Q 2018. Except for that one-time 3Q 2017 reserve adjustment, DLits direct labor and MOH productivity in both 3Q and 9M 2018 wasmanufacturing overhead costs consistent with 3Q and 9M 2017 on a variable sales basis. Expected higher tariffs are playing a role in UTMD vendor quotes for DM. With only a few exceptions, UTMD has not yet raised finished device prices to its customers in response to higher DM costs.the prior year’s periods.

d) Operating Income (OI)

OIOperating Income is GPGross Profit minus Operating Expense (OE).  Due to lower GP and higher OE, OI in 3Q and 9M 2018 was $4,402 and $14,429 respectively, compared to $4,679 and $14,438 in 3Q and 9M 2017 respectively. Although lower OI with higher sales diluted UTMD's 3Q and 9M 2018 OIMs compared to 3Q and 9M 2017, per the table above, UTMD's continued excellent OIM remains key to its financial success.
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OE areExpenses.  Operating Expenses, comprised of general and administrative (G&A)G&A expenses, sales and marketing (S&M) expenses and product development (R&D) expenses. Consolidated USD-denominated OEexpenses, were $3,008 in 3Q 2019 (24.1% of sales) compared to $1,892 in 3Q 2018 (18.2% of consolidated revenues)sales). Operating Expenses were $8,698 in 9M 2019 (24.8% of sales) compared to $1,817 in 3Q 2017 (17.9% of consolidated revenues). Consolidated OE were $5,771 in 9M 2018 (17.9% of revenues) compared to $5,487sales). The higher Operating Expenses in 2019 were essentially the result of the new IIA amortization expense included in G&A expenses which was $1,105 in 3Q 2019 and $2,947 in 9M 2017 (17.6% of revenues).2019.

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OE  3Q 2018  3Q 2017  Change   9M 2018   9M2017  Change 
S&M  $452  $364   + 88  $1,291  $1,154   + 137 
G&A   1,332   1,350   (18)  4,142   3,993   + 149 
R&D   108   103   + 5   338   341   (2)
Total OE:  $1,892  $1,817   + 75  $5,771  $5,487   + 284 

Operating Expenses 3Q 2019  3Q 2018  Change   9M 2019   9M2018  Change 
S&M $422  $452   (30) $1,304  $1,291   + 13 
G&A  2,456   1,332   +1,124   7,037   4,142   +2,895 
R&D  130   108   + 22   357   338   + 19 
Total: $3,008  $1,892   + 1,116  $8,698  $5,771   + 2,927 

S&M expenses were 3.4% of sales in 3Q 2019 compared to 4.3% of revenuessales in 3Q 2018 compared to 3.6% of revenues in 3Q 2017. In 9M 2018,2018.  S&M expenses were 3.7% of sales in 9M 2019 compared to 4.0% of revenues compared to 3.7% of revenuessales in 9M 2017. Consolidated2018.  The change in FX rates reduced 3Q 2019 OUS S&M expenses increased because UTMD added a marketing person in the U.S.by $6, and a fluent French-speaking S&M person in the UK to help better service direct accounts in France.  UTMD also expanded participation in clinical trade shows in 9M 2018.  In addition, although changed FX rates did not increase 3Q 20182019 OUS subsidiary S&M expenses relative to 3Q 2017, they did increase 9M 2018 OUS S&M expense by $15.  In other words, 11% of the 9M consolidated S&M expense increase was due to FX rate differences.$24.

S&M expenses include all customer support costs including training. In general, training is not required for UTMD'sUTMD’s medical devices since they are well-established and have been clinically widely used. Written "Instructions“Instructions For Use"Use” are packaged with all finished devices. Although UTMD does not have any explicit contracts with customers to provide training, it does have agreements in the U.S. and UKmarkets where it sells directly to end user facilities under which it agrees to provide hospital members inservice and clinical training as required and reasonably requested.

UTMD promises prospective customers that it will provide, at no charge in reasonable quantities, copies of instruction materials developed for the use of its products. UTMD provides customer support from offices in the U.S., Canada, the UK, Ireland and Australia by telephone, and employed representatives on a geographically dispersed basis, to answer user questions and help troubleshoot any user issues. Occasionally, on a case-by-case basis, UTMD may utilize the services of an independent practitioner to provide educational assistance to clinicians.  All inservice and training expenses are routinely expensed as they occur.  All of these services are allocated from S&M overhead costs included in OE.Operating Expenses.  Historically, marginal consulting costs have been immaterial to financial results.

Consolidated G&A expenses were 19.7% of sales in 3Q 2019 compared to 12.8% of revenuessales in 3Q 2018 compared to 13.3% of revenues in 3Q 2017. In both 9M 2018 and 9M 2017,2018. The G&A expenses were 12.8% of revenues. G&A expenses include the cost of outside financial auditors and corporate governance activities related to the implementation of SEC rules resulting from the Sarbanes-Oxley Act of 2002, as well as estimated stock-based compensation cost, a noncash expense. Option compensation expense included in G&A expenses was $11 in 3Q 2018 compared to $30 in 3Q 2017, and $53 in 9M 2018 compared to $99 in 9M 2017.  G&A expenses also include2019 included $492 (3.9% of sales) of non-cash expense from the amortization of identifiable intangible assets (IIA) which resultedIIA resulting from the 2011 Femcare acquisition.  Althoughacquisition, which were $520 (5.0% of sales) in 3Q 2018.  The lower USD IIA amortization expense was the result of the stronger USD, as the Femcare amortization expense in GBP was the same for the respective periods£399 in both 2018 and 2017, in USD termsperiods.  In addition, 3Q 20182019 G&A expenses included a new $1,105 (8.8% of sales) IIA amortization expense resulting from the purchase of the CSI U.S. exclusive Filshie devices distribution rights.  Excluding both the Filshie-related non-cash IIA was $2 lower thanamortization expenses, G&A expenses were $859 (6.9% of sales) in 3Q 2017, and2019 compared to $812 (7.8% of sales) in 3Q 2018.  The change in FX rates reduced 3Q 2019 OUS G&A expenses excluding IIA amortization expense by $15.

Consolidated G&A expenses were 20.1% of sales in 9M 2018 $91 higher than2019 compared to 12.8% of sales in 9M 2017.  In other words, the FX rate change impact on IIA asset amortization expense represented 61% of the increase in consolidated 9M 2018 G&A expenses. Including all G&A expenses, the FX rate change represented 92% of the $149 increase in total consolidated2018. The G&A expenses in 9M 20182019 included $1,524 (4.3% of sales) of non-cash expense from the amortization of IIA resulting from the 2011 Femcare acquisition, which were $1,617 (5.0% of sales) in 9M 2018.  The lower USD IIA amortization expense was the result of the stronger USD, as the Femcare amortization expense in GBP was £1,196 in both periods.  In addition, 9M 2019 G&A expenses included a new $2,947 (8.4% of sales) IIA amortization expense resulting from the purchase of the CSI U.S. exclusive Filshie devices distribution rights.  In constant currency and excluding the Filshie-related non-cash IIA amortization expenses, G&A expenses were $2,627 (7.5% of sales) in 9M 2019 compared to $2,525 (7.8% of sales) in 9M 2017.2018.  The change in FX rate change represented 49% of the $18 decrease in total consolidatedrates reduced 9M 2019 OUS G&A expenses in 3Q 2018 compared to 3Q 2017. In other words, in the aggregate there were no significant changes to G&A expenses other than the FX rate impact.excluding IIA amortization expense by $62.

R&D expenses in 3Q 2019 were 1.0% of sales compared to 1.0% of sales in both 3Q 2018 and 3Q 2017.2018. R&D expenses in 9M 2019 were 1.0% of sales compared to 1.0% of sales in 9M 2018 compared to 1.1% of sales in 9M 2017. As virtually2018. Since almost all R&D expenses wereis being carried out in the U.S., therethe FX impact was no FX rate impact.negligible.

VariationsIn 3Q 2019 compared to 3Q 2018, a stronger USD reduced OUS Operating Expenses excluding the 2011 Femcare IIA amortization expense in R&D expenses result from costsUSD terms by $21. The £399 Femcare IIA amortization expense in both 3Q 2019 and 3Q 2018 was reduced by $28.  In 9M 2019 compared to 9M 2018, a stronger USD reduced OUS Operating Expenses excluding Femcare IIA amortization expense in USD terms by $86.  In addition, the same £1,196 Femcare IIA 9M amortization expense in both 9M periods was reduced by $93.

In constant currency and ignoring the new IIA amortization expense (from purchasing the CSI distribution agreement) which was not present in 2018, 3Q 2019 Operating Expenses were $1,952 (15.6% of projects, including engineering time,sales), and 9M 2019 Operating Expenses were $5,930 (16.9% of sales).

In summary, Operating Income in different stages3Q 2019 was $4,371 (35.0% of completion. At UTMD, R&D engineers also devote muchsales) compared to $4,402 (42.4% of their timesales) in 3Q 2018.  The slightly lower 3Q 2019 Operating Income was due to manufacturing process improvements.a product mix that included lower GPMs on higher OEM sales and pressure monitoring kit sales to a China distributor.  The incremental Gross Profit gained on direct sales of the Filshie Clip System in the U.S. at distributor margin essentially offset the new $1,105 IIA amortization expense, as planned.  Excluding the new CSI acquisition IIA amortization expense which was not applicable in 3Q 2018, Operating Income in 3Q 2019 increased $1,075 (+24.4%). Operating Income in 9M 2019 was $12,954 (36.9% of sales) compared to $14,429 (44.8% of sales) in 9M 2018.  Excluding the new 9M 2019 CSI acquisition IIA amortization expense which was not applicable in 9M 2018, OI increased $1,472 (+10.2%).
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e) Non-operating expense (NOE)/expense/ Non-operating income (NOI)

NOE/NOINon-operating expense includes the combination of 1) expenses from loan interest and bank fees; 2) expenses orlosses from remeasuring the value of EUR cash bank balances in the UK, and GBP cash balances in Ireland, in USD terms; and 3) losses from disposition of assets.  Non-operating income includes 1) investment income from losses orcash deposit balances; 2) rent of underutilized property; 3) royalties received from licensing the Company’s technology; 4) gains from dispositions of assets; and 5) gains from remeasuring the value of EUR cash bank balances in the UK, and GBP cash balances in Ireland, in USD terms; 3)terms.

Net non-operating income from rent of underutilized property, investment(non-operating income and royalties received from licensing the Company's technology; and 4) losses or gains from dispositions of assets. Negative NOE is NOI.  Net NOIminus non-operating expenses) in 3Q 20182019 was $79$76 compared to $17$79 in 3Q 2017. Interest2018. Net non-operating income on cash balances in the U.S. were $60 higher in 3Q 2018 than in 3Q 2017 due to higher interest rates and cash repatriated from OUS subsidiaries. Net NOI in 9M 20182019 was $617$196 compared to $66$617 in 9M 2017.2018.  The difference in 9M 2018 compared to 9M 2017 was largelyessentially due to a one-time $418 gain on the 2Q 2018 sale of a storage facility in Utah that was no longer needed, and a $32 gain on the sale of other investments, in 2Q 2018.needed. There were no similar asset dispositions in 2017. Although in all four periods2019.  In 3Q 2019, UTMD recognized a $2 gain from remeasurement of time UTMD experienced a gain on remeasuredthe value of foreign currency bank balances (RFCB), the gains were minimal. In 3Q 2018 the RFCB gain was $3 compared to a $3 gain of $4 in 3Q 2017.2018.   In 9M 2018,2019, UTMD recognized a $44 loss from remeasurement of the gain on RFCB was $10value of foreign currency bank balances compared to a $10 gain of $5 in 9M 2017.2018.  Royalties received were $0 in 3Q 2019 compared to $18 in 3Q 2018, and $6 in 9M 2019 compared to $23 in 3Q 2017, and $60 in 9M 2018 compared to $652018. Femcare had received a royalty from CSI as part of its exclusive U.S. distribution agreement which was purchased by UTMD in 9M 2017.early 2019.  Currently, UTMD is not receiving any royalties.

f) Income Before Income Taxes (EBT)

Consolidated EBT results from subtracting net non‑operating expense (NOE) from, or adding net non-operating income (NOI)from or to, OI.  NOE includes 1)as applicable, Operating Income. Consolidated 3Q 2019 EBT was $4,448 (35.6% of sales) compared to $4,481 (43.1% of sales) in 3Q 2018.  Consolidated 9M 2019 EBT was $13,150 (37.5% of sales) compared to $15,046 (46.7% of sales) in 9M 2018.

The EBT of Utah Medical Products, Inc. in the U.S. was $8,674 in 9M 2019 compared to $7,698 in 9M 2018. The EBT of Utah Medical Products, Ltd (Ireland) was EUR 2,157 in 9M 2019 compared to EUR 2,499 in 9M 2018. The EBT of Femcare Group Ltd (Femcare Ltd., UK and Femcare Australia Pty Ltd) was GBP 1,460 in 9M 2019 compared to GBP 2,725 in 9M 2018. The 9M 2019 EBT of Utah Medical Products Canada, Inc. (dba Femcare Canada) was CAD 926 in 9M 2019 compared to CAD 1,246 in 9M 2018.  The EBT of UTMD’s manufacturing subsidiaries varies as a result of intercompany shipments which are eliminated in the consolidation of results. The lower Femcare Group EBT was primarily the result of the lack of any loanUK shipments of Filshie devices to CSI in 2019. The lower Femcare Canada EBT was due to lower sales activity.

UTMD management believes that the presentation of a related non-US GAAP metric, adjusted consolidated EBITDA (EBITDA), provides meaningful supplemental information to both management and investors that more clearly focuses on UTMD’s operating results when considering the Company’s ability to generate cash to meet the needs of its business and provide adequate returns to stockholders. Although the sum of the components is a non-GAAP metric, the individual components of UTMD’s EBITDA are all US GAAP measures: EBT, interest which there was none in 2017expense, depreciation of fixed assets, amortization of patent expenses, amortization of IIA from the 2011 acquisition of Femcare Group Ltd, amortization of the IIA resulting from the purchase of the remaining life of the exclusive Filshie device distribution agreement from CSI, stock option compensation expense, and the gains or 2018, 2) bank fees and 3) losses from remeasuring the value of EUR cash bank balances in the UK, and GBP cash balances in Ireland, in USD terms, minus NOI from 1) rent of underutilized property, 2) investment income, 3) gains from remeasuring the value of EUR cash bank balances in the UK, and GBP cash balances in Ireland, in USD terms, 4) gains from the sale of assets and 5) royalties received from licensing the Company's technology. NOI is negative NOE. For clarity, the REPAT tax adjustment and 2018 GILTI tax estimated accrual do not affect EBT.terms.

Consolidated 3Q 2018 EBT was $4,481 (43.1% of sales) compared to $4,696 (46.4% of sales) in 3Q 2017. The difference was almost entirely due to lower GP in 3Q 2018 than in 3Q 2017. Consolidated 9M 2018 EBT was $15,046 (46.7% of sales) compared to $14,503 (46.5% of sales) in 9M 2017. In 9M 2018, $275 higher GP was offset by $284 higher OE.  Consequently, the $542 (+3.7%) higher EBT in 9M 2018 compared to 9M 2017 was essentially due to higher NOI. There was a $450 gain from sales of assets in 2Q 2018 that did not occur in 2017. The remeasured currency gain in 9M 2018 was $10 compared to $5 in 9M 2017. The remaining difference was due to higher interest income from UTMD's cash bank balances.(Table located on next page)
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Component of EBITDA 3Q 2019  3Q 2018  Change   9M 2019   9M 2018  Change 
EBT $4,448  $4,481   (0.7%) $13,150  $15,046   (12.6%)
Depreciation of fixed assets  171   182       526   577     
Amortization of patent expenses  13   15       41   46     
Amortization of Femcare IIA  492   520       1,524   1,617     
Amortization of CSI distribution agreement  IIA  1,105   -0-       2,947   -0-     
Stock option compensation expense  29   11       85   53     
Remeasured currency (gains) or losses  (2)  (3)      44   (10)    
Adjusted Consolidated EBITDA: $6,255  $5,206   +20.1% $18,317  $17,328   + 5.7%

The EBTnon-GAAP EBITDA metric more clearly demonstrates the improving operating performance benefit of UTMD's subsidiaries in Ireland and the UK results not only from trade sales but also intercompany sales. For clarity, the subsidiary profit resulting from intercompany sales is eliminated in UTMD's consolidated income results. Utah Medical Products, Ltd's (Ireland) EBT was EUR 2,499 in 9M 2018 compared to EUR 2,229 in 9M 2017. The higher 9M 2018 EBT in Ireland was due to 9% higher combined trade and intercompany sales. EBT of Femcare Group Ltd (Femcare Ltd., UK and Femcare Australia Pty Ltd) was GBP 2,841 in 9M 2018 compared to GBP 3,141 in 9M 2017. The lower Femcare Group EBT in 9M 2018 was due to the combination of 1) prior 2017 international sales from the UK converted to Ireland in 2018, and 2) 12.9% lower Australia sales (in AUD) combined with a 6.6% weaker AUD compared to the GBP. The EBT of Utah Medical Products Canada, Inc. in 9M 2018 was CAD 1,246 compared to CAD 1,497 in 9M 2017.  The lower Canada EBT was due to 13.1% lower CAD sales in 9M 2018 compared to 9M 2017.

Excluding the noncash effects of depreciation, amortization of intangible assets and stock option expense, 3Q 2018 consolidated EBT excluding the noncash remeasured bank balance currency gain or loss and interest expense ("adjusted consolidated EBITDA") were $5,206 compared to $5,417 in 3Q 2017. The lower 3Q 2018 EBITDA was due to the lower GP in 3Q 2018. Adjusted consolidated EBITDA in 9M 2018 were $17,328 compared to $16,653 in 9M 2017.  Based on the 9M 2018 EBITDA results, management expects 2018 EBITDA for the year as a whole will be higher than the $21,979 EBITDA for 2017.

g)Net Income (NI)

NI is EBT minus a provision for income taxes. NI in 3Q 2018 per GAAP was substantially affected by a $3,230 favorable adjustment in UTMD's calculation of its "one-time" REPAT tax due under the TCJA enacted in December 2017.  In addition, in 3Q 2018, UTMD added its best estimateUTMD’s purchase of the new GILTI tax under the TCJA, although the IRS has yet to provide complete guidance on the calculation and the State of Utah has yet to provide any guidance. As there was no REPAT tax or GILTI tax calculation included in 3Q and 9M 2017 results, comparing period-to-period financial results net of income taxes does not provide meaningful information to stockholders, in UTMD's opinion. Therefore, in addition to the GAAP results, UTMD is providing a non-GAAP NI and EPS comparison which ignores the REPAT tax adjustment and GILTI tax accrual in 3Q 2018.
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In 3Q 2018, non-GAAP NI of $3,582 (34.5% of sales) was 1.1% lower than the 3Q 2017 NI of $3,622 (35.8% of sales).  Non-GAAP NI in 9M 2018 of $11,982 (37.2% of sales) was 8.7% higher than the NI of $11,027 (35.3% of sales) in 9M 2017. The higher non-GAAP NI in 9M 2018 was due to 3.7% higher EBT in combination with a lower corporate income tax rate in the U.S. The non-GAAP consolidated income tax provision rates in 3Q 2018 and 9M 2018 were 20.1% and 20.4% respectively, compared to provision rates of 22.9% in 3Q 2017 and 24.0% in 9M 2017 (before the enactmentremaining life of the TCJA which lowered the U.S. corporate income tax rate from 34% to 21%).

Femcare distribution agreement with CSI.  In 3Q 2018, GAAP NI of $6,762 was 86.7% higher than the 3Q 2017 NI of $3,622.  GAAP NI in 9M 2018 of $15,162 was 37.5% higher than the NI of $11,027 in 9M 2017.

For the benefit of stockholders, UTMD believes that further discussion of its current understanding of the impact of tax law changes resulting from the TCJA might be helpful. As stockholders likely remember, 4Q 2017 results according to U.S. Generally Accepted Accounting Principles (GAAP) were affected by the recognition of an estimated "one-time" U.S. repatriation tax (REPAT tax) on foreign E&P resulting from the TCJA enacted by Congress in December 2017.  UTMD's reasonable total REPAT tax estimate was $6,288 ($1.68 per share), including an estimated Utah State assessment of $1,065 and a $362 Federal REPAT tax credit for the State REPAT tax.

As more IRS information regarding the REPAT tax rules became available during 2018, and in conjunction with completing and filing its 2017 tax returns, UTMD learned that it needed to adjust its provisional assessment as it completed a "more likely than not" assessment in 3Q 2018.  The results of the assessment are a total REPAT tax of $3,058, including an estimated Utah State assessment of $1,066 and a $362 Federal REPAT tax credit for the State REPAT tax.

The $3,230 ($0.86 per share based on 3Q 2018 diluted shares) adjusted lower REPAT tax liability has been included in 3Q 2018 financial results per SEC SAB 118. The adjustment was primarily due to the application of a Foreign Tax Credit calculation per IRS rules instead of reducing the REPAT tax obligation merely by the actual foreign taxes paid, which was the basis for the initial estimate.

New "Global Intangible Low-taxed Income" (GILTI) Tax. Supposedly, the TCJA changed the U.S. tax system from one where worldwide income of U.S. corporations was taxed (when foreign subsidiary profits were repatriated) to one which only taxes income earned within the U.S. The REPAT tax was explained to be a "one-time" tax of 15.5% on liquid assets and 8% on illiquid assets resulting from cumulative foreign E&P, regardless of whether or not prior earnings had been repatriated.  In actuality, Congress walked back from the concept of not taxing future foreign earnings by slipping in a new GILTI tax.  This new tax apparently was aimed at corporations like Apple which had transferred intangible assets to low tax sovereignties, i.e. managed highest profits to be generated in the lowest taxed countries. Although UTMD does have OUS intangible assets acquired in the acquisition of Femcare in 2011, these assets were clearly developed in the UK, not transferred from the U.S.  Also, UTMD's OUS average tax rate is about 19%, higher than the targeted low average foreign tax threshold of 13.125% over which a company like UTMD theoretically would not have to pay a GILTI tax.  However, it appears now that because of the way that the tax is calculated by IRS form rules, that nearly every company with international intangible assets will end up paying GILTI income taxes going forward.  If the State of Utah does not allow Foreign Tax Credits for GILTI Tax purposes, which remains to be determined, the annual State of Utah GILTI tax would be substantial, would eliminate any GILTI tax paid to the Federal government by virtue of the State tax credit allowed by the IRS and would clearly violate the premise of the one-time REPAT tax.  To date, according to UTMD's tax advisors, neither the IRS nor the State of Utah has provided clear rules for calculating the GILTI tax.

Using 2017 performance as a basis, assuming the corporate tax rate is not increased again during the next eight years and UTMD's current GILTI tax estimate is reasonable, the net annual gain to stockholders between the average payments of the REPAT and GILTI taxes and the higher NI resulting from lower income tax rates on future EBT is estimated to be about $280/ year, or about $.07/ share using current diluted number of shares.

In UTMD'sUTMD’s public disclosures, management attempts to explain its expectations in forward-looking statements for the benefit of its stockholders.  However, management also acknowledges that financial estimates and other business projections are subject to change, and that the Company assumes no obligation to update or disclose revisions to its prior forward-looking statements.

12g)Net Income


Net Income is EBT minus a provision for income taxes.  Net Income in 3Q 2019 of $3,705 was 45.2% lower than the US GAAP Net Income of $6,762 in 3Q 2018 which included a $3,230 favorable adjustment in UTMD’s calculation of its “one-time” REPAT tax due under the TCJA enacted in December 2017.  UTMD’s Net Income in 3Q 2019 was 3.4% higher than the non-GAAP 3Q 2018 non-GAAP Net Income of $3,582 which excludes the REPAT tax adjustment. The average consolidated income tax provision (as a % of EBT) in 3Q 2019 was 16.7% compared to 20.1% excluding the REPAT tax adjustment in 3Q 2018.  The 3Q 2019 lower provision rate was due to truing-up UTMD’s Utah state income tax provision on a cumulative basis after the 2019 Utah legislature enacted new taxable income apportionment criteria.

Net Income in 9M 2019 of $10,369 was 31.6% lower than the US GAAP Net Income of $15,162 in 9M 2018 which included the 3Q 2018 $3,230 favorable adjustment in UTMD’s calculation of its “one-time” REPAT tax due under the TCJA enacted in December 2017.  UTMD’s Net Income in 9M 2019 was 13.5% lower than the non-GAAP 9M 2018 Net Income of $11,982, which excludes the REPAT tax adjustment.  UTMD’s Net Income in 9M 2019 was after $2,947 IIA amortization expense which did not occur in 9M 2018.  The average consolidated income tax provisions (as a % of EBT) in 9M 2019 and 9M 2018 were 21.1% and 20.4%, respectively.

h) Earnings Per Share (EPS)

EPS are consolidated NINet Income divided by the number of shares of stock outstanding (diluted to take into consideration stock option awards which are "in“in the money," i.e., have exercise prices below the applicable period'speriod’s weighted average market value). Non-GAAP

Diluted EPS of $0.954$.991 in 3Q 2019 were 45.0% lower than $1.802 in 3Q 2018, which included a 3Q 2018 favorable EPS adjustment from UTMD’s recalculation of its “one-time” REPAT tax due under the TCJA enacted in December 2017.  UTMD’s EPS in 3Q 2019 was 3.9% higher than the non-GAAP 3Q 2018 EPS of $.954 excluding the REPAT tax adjustment.  Diluted shares were 1.5%3,737,335 in 3Q 2019 compared to 3,753,111 in 3Q 2018.

EPS of $2.774 in 9M 2019 were 31.4% lower than $4.041 in 9M 2018, which included the 3Q 2018 favorable EPS adjustment in UTMD’s calculation of its “one-time” REPAT tax due under the TCJA enacted in December 2017. UTMD’s EPS in 9M 2019 was 13.1% lower than the 3Q 2017 EPS of $0.969.  Non-GAAPnon-GAAP 9M 2018 EPS of $3.194 inwhich excludes the REPAT tax adjustment. The lower non-GAAP 9M 2018 were 8.1%EPS compared to higher than the EPS of $2.953 in 9M 2017.  The 8.1% higher 9M 2018 non-GAAP 3Q EPS was due to 8.7% higher NI diluted by 0.5% higher diluted shares. Looking forward, management continues to expect to exceed its beginningthe fact that in early 2019, the increased Gross Profit realized from direct sales of year projection for full year 2018 non-GAAP EPS.

In 3Q 2018, GAAP EPS of $1.802Filshie devices in the U.S. did not fully offset the additional expense from amortizing the IIA associated with purchasing the exclusive U.S. distribution rights from CSI on a straight line basis. Diluted shares were 85.9% higher than the 3Q 2017 EPS of $0.969.  GAAP EPS3,738,056 in 9M 2018 of $4.041 were 36.8% higher than the EPS of $2.9532019 compared to 3,751,830 in 9M 2017.2018.  The lower diluted shares in 2019 were the combined result of 15,000 shares repurchased in 4Q 2018 plus 5,000 shares repurchased in 2Q 2019, employee option exercises and a new option award in December 2018.

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Diluted shares outstanding used to calculate 3Q 2018 EPS were 3,753,111 compared to 3,738,190 in 3Q 2017.
The number of shares added as a dilution factor in 3Q 2018 was 19,876 compared to 19,300 in 3Q 2017.
Diluted shares outstanding used to calculate 9M 2018 EPS were 3,751,830 compared to 3,734,102 in 9M 2017.  The number of shares added as a dilution factor in 9M 2018 was 22,235 compared to 17,647 in 9M 2017.

Outstanding shares at the end of 3Q 20182019 were 3,734,165 which included 9M 20183,720,344 compared to 3,719,715 at the end of calendar year 2018. The difference was due to employee and outside director option exercises of 15,172 shares.5,629 during 9M 2019 offset by 5,000 shares repurchased in the open market. Outstanding shares were 3,734,165 at the end of 3Q 2018. The number of shares used for calculating earnings per shareEPS was higher than ending shares because of a time-weighted calculation of average outstanding shares plus dilution from unexercised employee and director options.  The total number of outstanding unexercised employee and outside director options at September 30, 20182019 was 39,168 shares53,914 at an average exercise price of $46.24/$58.27, including shares awarded but not yet vested.  This compares to 61,020 unexercised option shares at the end of 2018 at an average exercise price of $56.78/ share, including shares awarded but not vested. This compares

The number of shares added as a dilution factor in 3Q 2019 was 17,588 compared to 57,019 unexercised19,876 in 3Q 2018. The number of shares added as a dilution factor in 9M 2019 was 16,435 compared to 22,235 in 9M 2018.  In December 2018, 22,400 option shares outstandingwere awarded to 45 employees at September 30, 2017 at an average exercise price of $45.35/$74.64 per share. No other options were awarded in 2018, and no options were awarded in 9M 2019.

ExercisesUTMD paid $1,028 ($0.275/share) in dividends to stockholders in 3Q 2019 compared to $1,008 ($0.270/ share) paid in 3Q 2018. Dividends paid to stockholders during 3Q 2019 were 28% of employee options and dilution from a higher share price for unexercised options increased diluted shares. In3Q 2019 Net Income.  UTMD paid $3,083 ($0.275/share) in dividends to stockholders in 9M 2019 compared to $3,018 ($0.270/ share) paid in 9M 2018. Dividends paid to stockholders during 9M 2019 were 30% of 9M 2019 Net Income.

Near the end of December 2018, no new employee options were awarded. UTMD has not to date in 2018 repurchased any15,000 of its shares in the open market.market at $80.35/ share. During 2Q 2019, UTMD repurchased 5,000 of its shares at $79.52/ share. The Company retains the strong desire and financial ability for repurchasing its shares when they seem undervalued.at a price it believes is attractive for remaining stockholders.

i) Return on Stockholder Equity (ROE) and Stock Value

ROE is the portion of NINet Income retained by UTMD to internally finance its growth, divided by the average accumulated stockholders'stockholders’ equity for the applicable time period.  Annualized adjustedAfter payment of cash dividends to stockholders, annualized ROE in 9M 2018 (prior2019 was 11% compared to annualized adjusted (excluding the favorable REPAT Taxtax adjustment) was 14% compared toROE of 14% in 9M 2017.  Annualized adjusted2018. Before the payment of dividends, annualized ROE (before stockholder dividends)in 9M 2019 was 15% compared to 19% in 9M 2018 was 19% compared to 20% in 9M 2017.(excluding the favorable REPAT tax adjustment).  The lower adjusted ROE before dividends in 9M 20182019 was due to an 11%a 10% increase in average accumulated stockholders'stockholders’ equity with only a 9% increase13% decrease in NI.Net Income. Targeting a high ROE of 20% (before dividends) remains a key financial objective for UTMD management.  ROE can be increased by increasing NI, or by reducing stockholders' equity by paying cash dividends to stockholders or by repurchasing shares.

UTMD’s closing share price at the end of 3Q 2019 was $95.84, up slightly from $95.70 at the end of 2Q 2019, and up 15% from the $83.08 closing price at the end of 2018.  The closing share price at the end of 3Q 2018 was $94.20.

Liquidity and Capital Resources

j) Cash flows

Net cash provided by operating activities, including adjustments for depreciation and amortization and other non-cash expenses along with changes in working capital, totaled $11,415 in 9M 2019 compared to $12,350 in 9M 2018 compared to $12,323 in 9M 2017.2018.  The most significant differences in the two periods were the $4,135 higher increase in$4,793 lower net income (largely due to the REPAT Tax adjustment),adjustment in 3Q 2018) offset by no increase in the long term REPAT tax payable versus a $4,258 higher$2,727 decrease in 9M 2018, accrued expensesand a $1,704 larger net decrease in inventories (due to the CSI distribution agreement and Filshie device inventory purchase) offset by $2,849 higher 9M 2019 amortization (also due to the REPAT Tax adjustment),CSI distribution agreement purchase).  In 9M 2018, there was also a $441$495 benefit to cash from the sale of assets and non-cash investments that did not recur in 9M 2019.  In 9M 2019, there was also a $392$295 use of cash from a smallerlarger decrease in accrued expenses and $191 larger increase in accounts receivable a $556 benefit to cash from a decrease in inventories compared to an increase in 9M 2017, and a $459 use of cash from a decrease in accounts payable in 9M 2018 compared to an increase in 9M 2017.2018.

Capital expenditures for property and equipment (PP&E) were $251 in 9M 2019 compared to $255 in 9M 2018 compared to $174 in 9M 2017.2018.   Depreciation of PP&E was $526 in 9M 2019 compared to $577 in 9M 2018 compared to $489 in 9M 2017.2018.

UTMD made cash dividend payments of $3,083 in 9M 2019 compared to $3,018 in 9M 2018 compared to $1,969 in 9M 2017.2018.  The Company did not useused $398 of its cash to repurchase any5,000 of its own shares during either 9M 2018 or2019, but did not repurchase shares in 9M 2017.2018.

In 9M 2019, UTMD received $222 and issued 5,629 shares of its stock upon the exercise of employee and director stock options. Option exercises in 9M 2019 were at an average price of $39.53 per share.  In comparison, in 9M 2018 UTMDthe Company received $436 and issued 12,733 shares of its stock uponon the exercise of employee and director stock options, net of 2,439 shares retired upon employeesoptionees trading those shares in payment of the stock option exercise price. Option exercises in 9M 2018 were at an average price of $43.58 per share.  In comparison, in 9M 2017 the Company received $224 and issued 6,198 shares of stock on the exercise of employee and director stock options, net of 211 shares retired upon optionees trading those shares in payment of the stock option exercise price. Option exercises in 9M 2017 were at an average price of $37.39 per share.
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Management believes that current cash balances, income from operations and effective management of working capital will provide the liquidity needed to finance internal growth plans. The Company may utilize cash not needed to support normal operations in one or a combination of the following:  1) in general, to continue to invest at an opportune time in ways that will enhance future profitability; 2) to make additional investments in new technology and/or processes; and/or 3) to acquire a product line or company that will augment revenue and EPS growth and better utilize UTMD'sUTMD’s existing infrastructure.  If there are no better strategic uses for UTMD'sUTMD’s cash, the Company will continue to return cash to stockholders in the form of dividends and share repurchases when the stock appears undervalued.

k) Assets and Liabilities

September 30, 20182019 total consolidated assets were $99,151,$104,094, an increase of $6,407$4,326 from December 31, 2017.2018. The increase was primarily due to a $9,398$15,809 period-ending increase in net intangible assets offset by a $11,390 decrease in consolidated current assets. Changes in current assets, which were associated with UTMD’s purchase of the remaining life of an exclusive U.S. distribution agreement for Filshie devices, were a $13,719 decrease in cash and investments. Other significant changes in assets includedinvestments, offset by a $852$1,756 increase in consolidated net trade receivables, a $323 decrease in consolidatedU.S. inventories and a $2,413 decrease$1,216 increase in net intangible assets. UTMD'sU.S. accounts receivable. UTMD’s Ireland subsidiary EUR-denominated assets and liabilities on September 30, 20182019 were translated into USD at an FX rate 3.3%4.8% lower (weaker EUR relative to the USD) than the FX rate at the end of 2017. UTMD's2018. UTMD’s UK subsidiary GBP-denominated assets were translated into USD at an FX rate 3.4%3.6% lower (weaker GBP) than the FX rate at the end of 2017.  UTMD's2018.  UTMD’s Australia subsidiary AUD-denominated assets were translated into USD at an FX rate 7.4%4.2% lower (weaker AUD) than the FX rate at the end of 2017.  UTMD's2018.  UTMD’s Canada subsidiary CAD-denominated assets were translated into USD at an FX rate 3.1% lower (weaker3.0% higher (stronger CAD) than the FX rate at the end of 2017.2018.  The net book value of consolidated property, plant and equipment decreased $1,047$93 at September 30, 20182019 from the end of 20172018 due to period-ending changed FX rates, $255$251 in new asset purchases and $577$526 in depreciation.

Working capital (current assets minus current liabilities) was $54,285$45,827 at September 30, 20182019 compared to $43,909$55,643 at December 31, 2017.  A current asset increase2018 prior to the 1Q 2019 $23,098 purchase of $9,867 was dominated by the $9,398 increase in cashFilshie device U.S. distribution rights and investments. A currentinventory from CSI. Consolidated receivables and inventories increased $1,112 and $1,298, respectively.  Accrued liabilities decrease of $510 was largely due to a $418declined $1,385, primarily from $800 lower current portion of REPAT tax liability, since UTMD essentially paid two years' of adjusted REPAT tax liability in 2018 before it understood it had originally estimated its REPAT tax liability too high.accrued income taxes and $520 lower customer deposits. UTMD management believes that its working capital remains sufficient to meet normal operating needs, new capital expenditures and projected cash dividend payments to stockholders.

September 30, 20182019 net intangible assets (goodwill plus other intangible assets) decreased $2,413assets less amortization) increased $15,809 from the end of 2017.2018.  The decrease was due tonew intangible assets acquired in 1Q 2019 as part of the 3.4% lower FX rate for GBP Femcare intangibles as of September 30, 2018 compared to year-end 2017, plus $1,617 9M 2018 amortization of Femcare IIA.CSI exclusive U.S. distribution agreement purchase were $21,000.  At September 30, 2018,2019, net intangible assets including goodwill declined to 30%were 42% of total consolidated assets compared to 34%29% at year-end 2017,2018, and 36%30% at September 30, 2017.2018.

The deferred tax liability balance for Femcare IIA ($9,084 on the date of the acquisition) was $2,170 at September 30, 2019, compared to $2,541 at December 31, 2018, and $2,698 at September 30, 2018, compared to $3,102 at December 31, 2017, and $3,175 at September 30, 2017.2018.  Reduction of the deferred tax liability occurs as the book/tax difference of IIA amortization is eliminated over the remaining useful life of the Femcare IIA. UTMD'sUTMD’s total debt ratio (total liabilities/ total assets) as of September 30, 20182019 was 10%9%, including the remaining $2,526$2,441 REPAT tax liability payable over another sevensix years.  The total debt ratio as of December 31, 20172018 was 16%11%, and as of September 30, 2017 (before enactment of the TCJA)2018 was 10%.

l) Management's Outlook

As outlined in its December 31, 20172018 SEC 10-K report, UTMD'sUTMD’s plan for 2018 is2019 was to

1)continue to exploit distribution and manufacturing synergies by further integrating capabilities and resources in its multinational operations;
2)focus on effective direct marketing of the benefits of the FILSHIE Clip System in the U.S.;
3)introduce additional products helpful to clinicians through internal new product development;
3)4)continue achievingto achieve excellent overall financial operating performance;
4)5)utilize positive cash generation to continue providing cash dividends to stockholders and make open market share repurchases if/when the UTMD share price seems undervalued; and
5)6)be vigilant for accretive acquisition opportunities which may be increasingly brought about by difficult burdens on small, innovative companies.

In general, the Company continues to effectively execute its plan as outlined above.  Based on results of 9M 2018, management expects to exceed the financial objectives for the full year of 2018 as stated in the Form SEC 10-K at the beginning of the year.
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m)Accounting Policy Changes

On January 1, 2018 UTMD adopted ASU 2014-09, Revenue from Contracts with Customers. On January 1, 2019 UTMD adopted ASC Update No. 2016-02, Leases (Topic 842).  Refer to Note 2 for further information.2.

Forward-Looking Information.  This report contains certain forward-looking statements and information relating to the Company that are based on the beliefs of management as well as assumptions made by management based on information currently available.  When used in this document, the words "anticipate," "believe," "project," "estimate," "expect," "intend"“anticipate,” “believe,” “project,” “estimate,” “expect,” “intend” and similar expressions, as they relate to the Company or its management, are intended to identify forward-looking statements.  Such statements reflect the current view of the Company respecting future events and are subject to certain risks, uncertainties and assumptions, including the risks and uncertainties stated throughout the document.  Although the Company has attempted to identify important factors that could cause the actual results to differ materially, there may be other factors that cause the forward statement not to come true as anticipated, believed, projected, expected, or intended.  Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may differ materially from those described herein as anticipated, believed, projected, estimated, expected or intended.  Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results, and the Company assumes no obligation to update or disclose revisions to those estimates.

Item 3. Quantitative and Qualitative Disclosures about Market Risk

UTMD has manufacturing and trading operations, including related assets, in the U.S. denominated in the U.S. Dollar (USD), in Ireland denominated in the Euro (EUR), in England denominated in the British Pound (GBP), in Australia denominated in the Australia Dollar (AUD), and, starting in 2017, in Canada denominated in the Canadian Dollar (CAD).  The currencies are subject to exchange rate fluctuations that are beyond the control of UTMD.  The exchange rates were .8601, .8319.9169, .8729 and .8465.8601 EUR per USD as of September 30, 2018,2019, December 31, 20172018 and September 30, 2017,2018, respectively.  Exchange rates were .7463, .7395.8129, .7837 and .7659.7643 GBP per USD as of September 30, 2018,2019, December 31, 20172018 and September 30, 2017,2018, respectively.  Exchange rates were 1.3814, 1.27961.4823, 1.4193 and 1.27561.3814 AUD per USD on September 30, 2018,2019, December 31, 2017,2018, and September 30, 2017,2018, respectively.  Exchange rates were 1.2921, 1.2519,1.3242, 1.3644, and 1.25131.2921 CAD per USD on September 30, 2018,2019, December 31, 2017,2018, and September 30, 2017,2018, respectively. UTMD manages its foreign currency risk without separate hedging transactions by either invoicing customers in the local currency where costs of production were incurred, by converting currencies as transactions occur, and by optimizing global account structures through liquidity management accounts.

 Item 4. Controls and Procedures

The Company'sCompany’s management, under the supervision and with the participation of the Chief Executive Officer and the Principal Financial Officer, evaluated the effectiveness of the Company'sCompany’s disclosure controls and procedures (as defined in Rule 13a-15(e) under the Securities Exchange Act of 1934, as amended) as of September 30, 2018.2019. Based on this evaluation, the Chief Executive Officer and Principal Financial Officer concluded that, as of September 30, 2018,2019, the Company'sCompany’s disclosure controls and procedures were effective.
 
There were no changes in the Company'sCompany’s internal controls over financial reporting that occurred during the nine months ended September 30, 2018,2019, that have materially affected, or are reasonably likely to materially affect, the Company'sCompany’s internal controls over financial reporting.
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PART II - OTHER INFORMATION

Item 1.   Legal Proceedings

The Company may be a party from time to time in litigation incidental to its business.  Presently, there is no litigation the outcome of which is expected to be material to financial results.

Item 1A.   Risk Factors

In addition to the other information set forth in this report, investors should carefully consider the factors discussed in Part I, "Item“Item 1A. Risk Factors"Factors” in UTMD'sUTMD’s Annual Report on Form 10-K for the year ended December 31, 2017,2018, which could materially affect its business, financial condition or future results.  The risks described in the Annual Report on Form 10-K are not the only risks facing the Company.  Additional risks and uncertainties not currently known to UTMD or currently deemed to be immaterial also may materially adversely affect the Company'sCompany’s business, financial condition and/or operating results.

Legislative healthcare reform in the United States, as embodied in The Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (the "Acts"“Acts”) added a substantial excise tax (MDET)  in 2013-2015 that  increased administrative costs and has led to decreased revenues and new product development in the U.S.:  Although the tax was suspended for 2016-2019, it is currently due again beginning in 2020:
The voluminous Acts, administrative rules to enforce the Acts and promised efforts to reform the Acts, make the U.S. medical device marketplace unpredictable, particularly for the thousands of small medical device manufacturers including UTMD that do not have the overhead structure that the larger medical device companies can afford.  Fortunately, the U.S. Congress has suspended the MDET for years of 2016 through 2019.  To the extent that the Acts will in the future continue to place additional burdens on small medical device companies in the form of the excise tax on medical device sales, additional oversight of marketing and sales activities and new reporting requirements, the result is likely to continue to be negative for UTMD'sUTMD’s ability to effectively compete and support continued investments in new product development and marketing of specialty devices in the U.S.

Increasing regulatory burdens including premarketing approval delays may result in significant loss of revenue, unpredictable costs and loss of management focus on helping the Company proactively conform with  requirements and thrive:
The Company'sCompany’s experience in 2001-2005, when the FDA improperly sought to shut it down, highlights the ongoing risk of being subject to a regulatory environment which can be arbitrary and capricious. The risks associated with such a circumstance relate not only to the substantial costs of litigation in millions of dollars, but also loss of business, the diversion of attention of key employees for an extended period of time, including new product development and routine quality control management activities, and a tremendous psychological and emotional toll on dedicated and diligent employees.

Since the FDA reserves to itself the interpretation of which vague industry standards comprise law at any point in time, it is impossible for any medical device manufacturer to ever be confident that it is operating within the Agency'sAgency’s version of the law.  The unconstitutional result is that companies, including UTMD, are considered guilty prior to proving their innocence.

Premarketing submission administrative burdens and substantial increases in "user fees"“user fees” increase product development costs and result in delays to revenues from new or improved devices.  It recently took two and a half years to gain FDA approval of the use of a clearly safer single use Filshie Clip applicator, which had been in use for over seven years OUS, in lieu of a reused applicator approved in the U.S. since 1996, made of substantially equivalent materials for the same intended use applying the same implanted clip.

The growth of Group Purchasing Organizations (GPOs) adds non-productive costs, typically weakens the Company'sCompany’s marketing and sales efforts and may result in lower revenues:
GPOs, theoretically acting as bargaining agents for member hospitals, but actually collecting revenues from the companies that they are negotiating with, have made a concerted effort to turn medical devices that convey special patient safety advantages and better health outcomes, like UTMD's,UTMD’s, into undifferentiated commodities. GPOs have been granted an antitrust exemption by the U.S. Congress. Otherwise,In any other industry, their business model based on "kickbacks"“kickbacks” would be a violation of law.  These bureaucratic entities do not recognize or understand the overall cost of care as it relates to safety and effectiveness of devices, and they create a substantial administrative burden that is primarily related to collection of their administrative fees.

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The Company'sCompany’s business strategy may not be successful in the future:
As the level of complexity and uncertainty in the medical device industry increases, evidenced, for example, by the unpredictable regulatory environment, the Company'sCompany’s views of the future and product/ market strategy may not yield financial results consistent with the past.
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As the healthcare industry becomes increasingly bureaucratic it puts smaller companies like UTMD at a competitive disadvantage:
An aging population is placing greater burdens on healthcare systems, particularly hospitals. The length of time and number of administrative steps required in adopting new products for use in hospitals has grown substantially in recent years.  Smaller companies like UTMD typically do not have the administrative resources to deal with broad new administrative requirements, resulting in either loss of revenue or increased costs.  As UTMD introduces new products it believes are safer and more effective, it may find itself excluded from certain clinical users because of the existence of long term supply agreements for preexisting products, particularly from competitors which offer hospitals a broader range of products and services.  Restrictions used by hospital administrators to limit clinician involvement in device purchasing decisions makes communicating UTMD'sUTMD’s clinical advantages much more difficult.

A product liability lawsuit could result in significant legal expenses and a large award against the Company:
UTMD'sUTMD’s devices are frequently used in inherently risky situations to help physicians achieve a more positive outcome than what might otherwise be the case.  In any lawsuit where an individual plaintiff suffers permanent physical injury, the possibility of a large award for damages exists whether or not a causal relationship exists.

The Company'sCompany’s reliance on third party distributors in some markets may result in less predictable revenues:
UTMD'sUTMD’s distributors have varying expertise in marketing and selling specialty medical devices.  They also sell other devices that may result in less focus on the Company'sCompany’s products.  In some countries, notably China, Pakistan and India not subject to similarly rigorous standards, by copying, a distributor of UTMD'sUTMD’s products may eventually become a competitor with a cheaper but lower quality version of UTMD'sUTMD’s devices.

The loss of one or more key employees could negatively affect UTMD performance:
In a small company with limited resources, the distraction or loss of key personnel at any point in time may be disruptive to performance.  The Company'sCompany’s benefits programs are key to recruiting and retaining talented employees.  An increase in UTMD'sUTMD’s employee healthcare plan costs, for example, may cause the Company to have to reduce coverages which in turn represents a risk to retaining key employees.

Fluctuations in foreign currencies relative to the USD can result in significant differences in period to period financial results:
Since a significant portion of UTMD'sUTMD’s sales are invoiced in foreign currencies and consolidated financial results are reported in USD terms, a stronger USD can have negative revenue effects. Conversely, a weaker USD would increase foreign subsidiary operating costs in USD terms. For the portion of sales to foreign entities made in fixed USD terms, a stronger USD makes the devices more expensive and weakens demand.  For the portion invoiced in a foreign currency, not only USD-denominated sales are reduced, but also gross profits may be reduced because finished distributed products and/or U.S. made raw materials and components are likely being purchased in fixed USD.

Item 2.  Unregistered Sales of Equity Securities and Use of Proceeds

During 9M 2019, UTMD purchased 5,000 of its shares in the open market for $398 including commissions and fees. UTMD did not purchase any of its own securities during 9M 2018.
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Item 6.  Exhibits

Exhibit #SEC Reference #Title of Document
   
1
31
   
231
   
332
   
432
   
5101 insXBRL Instance
   
6101.schXBRL Schema
   
7101.calXBRL Calculation
   
8101.defXBRL Definition
   
9101.labXBRL Label
   
10101.preXBRL Presentation

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SIGNATURES

Pursuant to the requirements of the Securities Exchanges Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 
UTAH MEDICAL PRODUCTS, INC.
 REGISTRANT
  
Date:  11/7/1819
By: /s/ Kevin L. Cornwell
 Kevin L. Cornwell
 CEO
  
Date:  11/7/1819
By: /s/ Brian L. Koopman
 Brian L. Koopman
 Principal Financial Officer



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