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



10-Q

    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, 20172020

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

Utah

87‑0342734

87-0342734

(State or other jurisdiction of incorporation or organization)

(I.R.S. Employer Identification No.)



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


Registrant's telephone number:   (801) 566‑1200


7043 South 300 West

Midvale, Utah  84047

(Address of principal executive offices) (Zip Code)

(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 value

UTMD

NASDAQ

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 is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company.  See the definitions of "large accelerated filer," "accelerated filer" and "smaller reporting company" in Rule 12b-2 of the Exchange Act.
Large accelerated filer 
Accelerated filer 
Non-accelerated filer
Smaller reporting company

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the 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 by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth 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 the number of shares outstanding of each of the issuer'sissuer’s classes of common stock as of November 6, 2017: 3,720,600.

5, 2020: 3,640,403.



UTAH MEDICAL PRODUCTS, INC.

INDEX TO FORM 10‑Q


10-Q

PAGE

PART I - FINANCIAL INFORMATION

PAGE

Item 1.

Financial Statements

Consolidated Condensed Balance Sheets as of September 30, 20172020 and December 31, 20162019

1

Consolidated Condensed Statements of Income for the three and nine months ended September 30, 20172020 and September 30, 20162019

2

Consolidated Condensed Statements of Cash Flows for the nine months ended September 30, 20172020 and September 30, 20162019

3

Consolidated Condensed Statements of Stockholders’ Equity for the three and nine months ended September 30, 2020 and September 30, 2019

4

Notes to Consolidated Condensed Financial Statements

4

5

Item 2.

Management's

Management’s Discussion and Analysis of Financial Condition and Results of Operations

6

9

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

13

18

Item 4.

Controls and Procedures

14

18

PART II – OTHER INFORMATION

Item 1.

Legal Proceedings

15

19

Item 1A.

Risk Factors

15

19

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

16

20

Item 6.

Exhibits

17

20

SIGNATURES

17

21



PART I - FINANCIAL INFORMATION
 
  
Item 1.  Financial Statements      
UTAH MEDICAL PRODUCTS, INC. AND SUBSIDIARIES
 
CONSOLIDATED CONDENSED BALANCE SHEETS AS OF 
SEPTEMBER 30, 2017 AND DECEMBER 31, 2016 
(in thousands) 
  
    (unaudited)  (audited) 
ASSETS 
SEPTEMBER 30,
 2017
  
DECEMBER 31,
2016
 
Current assets:      
 Cash $37,438  $26,296 
Investments, available-for-sale  78   64 
Accounts & other receivables, net  4,730   3,211 
Inventories  5,042   4,542 
Other current assets  733   754 
Total current assets  48,021   34,867 
Property and equipment, net  10,407   9,966 
Goodwill  14,028   13,487 
Other intangible assets  34,507   31,947 
Other intangible assets - accumulated amortization  (16,288)  (13,683)
Other intangible assets, net  18,219   18,264 
Total assets $90,675  $76,584 
         
LIABILITIES AND STOCKHOLDERS' EQUITY        
Current liabilities:        
Accounts payable $1,125  $906 
Accrued expenses  4,058   2,116 
Total current liabilities  5,183   3,022 
Deferred tax liability - intangible assets  3,176   3,209 
Deferred income taxes  1,119   1,109 
Total liabilities  9,478   7,340 
         
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, 2017, 3,719 shares and December 31, 2016, 3,713 shares  37   37 
Accumulated other comprehensive income (loss)  (8,686)  (12,243)
Additional paid-in capital  701   378 
Retained earnings  89,145   81,072 
Total stockholders' equity  81,197   69,244 
         
Total liabilities and stockholders' equity $90,675  $76,584 
see notes to consolidated condensed financial statements

Table of Contents


PART I - FINANCIAL INFORMATION

Item 1. Financial Statements

UTAH MEDICAL PRODUCTS, INC. AND SUBSIDIARIES

CONSOLIDATED CONDENSED BALANCE SHEETS AS OF

SEPTEMBER 30, 2020 AND DECEMBER 31, 2019

(in thousands)

 

(unaudited)

 

(audited)

SEPTEMBER 30, 2020

 

DECEMBER 31, 2019

ASSETS

 

 

 

Current assets:

 

 

 

Cash & investments

$    46,294

 

$    42,787

Accounts & other receivables, net

4,277

 

4,742

Inventories

6,304

 

6,913

Other current assets

385

 

444

Total current assets

57,260

 

54,886

Property and equipment, net

10,650

 

10,314

Operating lease – right of use assets, net

386

 

414

Goodwill

13,783

 

13,961

Other intangible assets

54,362

 

55,205

Other intangible assets - accumulated amortization

(29,369)

 

(24,993)

Other intangible assets, net

24,993

 

30,212

Total assets

$    107,072

 

$    109,787

 

 

 

 

LIABILITIES AND STOCKHOLDERS' EQUITY

 

 

 

Current liabilities:

 

 

 

Accounts payable

$         651

 

$         1,098

Accrued expenses

2,976

 

2,350

Total current liabilities

3,627

 

3,448

Deferred tax liability – Femcare IIA

1,995

 

2,110

Other long term liabilities

       2,132

 

       2,239

Operating lease liability

       346

 

376

Deferred income taxes

557

 

521

Total liabilities

8,657

 

8,694

 

 

 

 

Stockholders' equity:

 

 

 

Preferred stock - $0.01 par value; authorized - 5,000 shares; no shares issued or outstanding

-

 

-

Common stock - $0.01 par value; authorized - 50,000 shares; issued - September 30, 2020, 3,640 shares and December 31, 2019, 3,722 shares

36

 

37

Accumulated other comprehensive income (loss)

(10,199)

 

(9,782)

Additional paid-in capital

-

 

18

Retained earnings

108,578

 

110,820

Total stockholders' equity

98,415

 

101,093

 

 

 

 

Total liabilities and stockholders' equity

$    107,072

 

$    109,787

 

 

 

 

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, 2017 AND SEPTEMBER 30, 2016 
(in thousands, except per share amounts - unaudited) 
  
  THREE MONTHS ENDED  NINE MONTHS ENDED 
  SEPTEMBER 30,  SEPTEMBER 30, 
  2017  2016  2017  2016 
Sales, net $10,125  $9,655  $31,213  $30,446 
                 
Cost of goods sold  3,629   3,880   11,288   12,196 
Gross profit  6,496   5,775   19,925   18,250 
                 
Operating expense                
Selling, general and administrative  1,714   1,701   5,146   5,320 
Research & development  103   135   341   364 
Total operating expense  1,817   1,836   5,487   5,684 
Operating income  4,679   3,939   14,438   12,566 
                 
Other income (expense)  17   41   65   206 
Income before provision for income taxes  4,696   3,980   14,503   12,772 
                 
Provision for income taxes  1,074   1,045   3,476   3,361 
Net income $3,622  $2,935  $11,027  $9,411 
                 
Earnings per common share (basic) $0.97  $0.78  $2.97  $2.50 
                 
Earnings per common share (diluted) $0.97  $0.78  $2.95  $2.49 
                 
Shares outstanding - basic  3,719   3,761   3,716   3,757 
                 
Shares outstanding - diluted  3,738   3,778   3,734   3,775 
Other comprehensive income (loss):                
Foreign currency translation net of taxes of $0 in all periods $1,219  $(430) $3,550  $(3,856)
Unrealized gain (loss) on investments net of taxes of $2, $2, $5 and ($2)  4   3   9   (3)
Total comprehensive income $4,845  $2,508  $14,586  $5,552 
see notes to consolidated condensed financial statements

Table of Contents


UTAH MEDICAL PRODUCTS, INC. AND SUBSIDIARIES

CONSOLIDATED CONDENSED STATEMENTS OF INCOME FOR THE

THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2020 AND SEPTEMBER 30, 2019

(in thousands, except per share amounts - unaudited)

 

 

Three Months Ended

 

Nine Months Ended

 

 

September 30, 2020

 

September 30, 2019

 

September 30, 2020

 

September 30, 2019

 

 

 

 

Sales, net

 

$   10,479

 

$   12,494

 

$   30,168

 

$   35,073

 

 

 

 

 

 

 

 

 

Cost of goods sold

 

3,982

 

5,115

 

11,885

 

13,421

Gross profit

 

6,497

 

7,379

 

18,283

 

21,652

 

 

 

 

 

 

 

 

 

Operating expense

 

 

 

 

 

 

 

 

Selling, general and administrative

 

2,785

 

2,878

 

8,480

 

8,341

Research & development

 

125

 

130

 

375

 

357

Total operating expenses

 

2,910

 

3,008

 

8,855

 

8,698

Operating income

 

3,587

 

4,371

 

9,428

 

12,954

 

 

 

 

 

 

 

 

 

Other income (expense)

 

1

 

76

 

125

 

196

Income before provision for income taxes

 

3,588

 

4,447

 

9,553

 

13,150

 

 

 

 

 

 

 

 

 

Provision for income taxes

 

655

 

742

 

2,167

 

2,781

Net income

 

$     2,933

 

$     3,705

 

$    7,386

 

$    10,369

 

 

 

 

 

 

 

 

 

Earnings per common share (basic)

 

$       0.81

 

$       1.00

 

$       2.02

 

$       2.79

 

 

 

 

 

 

 

 

 

Earnings per common share (diluted)

 

$       0.80

 

$       0.99

 

$       2.01

 

$       2.77

 

 

 

 

 

 

 

 

 

Shares outstanding - basic

 

3,642

 

3,720

 

3,664

 

3,722

 

 

 

 

 

 

 

 

 

Shares outstanding - diluted

 

3,653

 

3,737

 

3,678

 

3,738

 

 

 

 

 

 

 

 

 

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

Foreign currency translation net of taxes of $0 in all periods

 

$     1,511

 

$  (1,683)

 

$     (416)

 

$  (1,200)

Total comprehensive income

 

$     4,444

 

$     2,022

 

$     6,970

 

$     9,169

 

 

 

 

 

 

 

 

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, 2017 AND SEPTEMBER 30, 2016 
(in thousands - unaudited) 
  
  SEPTEMBER 30, 
  2017  2016 
CASH FLOWS FROM OPERATING ACTIVITIES:      
Net income $11,027  $9,411 
Adjustments to reconcile net income to net cash provided by operating activities:        
Depreciation  489   452 
Amortization  1,568   1,714 
Provision for (recovery of) losses on accounts receivable  (2)  0 
(Gain) loss on disposal of assets  -   5 
Deferred income taxes  (281)  (351)
Stock-based compensation expense  99   62 
Tax benefit attributable to exercise of stock options  25   37 
  Changes in operating assets and liabilities:        
Accounts receivable - trade  (1,340)  (510)
Accrued interest and other receivables  (5)  (35)
Inventories  (301)  (222)
Prepaid expenses and other current assets  40   36 
Accounts payable  201   316 
Accrued expenses  803   228 
Total adjustments  1,296   1,732 
Net cash provided by operating activities  12,323   11,143 
         
CASH FLOWS FROM INVESTING ACTIVITIES:        
Capital expenditures for:        
Property and equipment  (174)  (237)
Intangible assets  -   (9)
Net cash (used in) provided by investing activities  (174)  (246)
         
CASH FLOWS FROM FINANCING ACTIVITIES:        
Proceeds from issuance of common stock - options  224   306 
Payment of dividends  (1,969)  (1,954)
Net cash (used in) provided by financing activities  (1,745)  (1,648)
         
Effect of exchange rate changes on cash  738   (971)
         
Net increase in cash and cash equivalents  11,142   8,278 
         
Cash at beginning of period  26,296   23,278 
         
Cash at end of period $37,438  $31,556 
         
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:        
Cash paid during the period for income taxes $3,753  $3,342 
Cash paid during the period for interest  -   - 
see notes to consolidated condensed financial statements

Table of Contents


UTAH MEDICAL PRODUCTS, INC. AND SUBSIDIARIES

CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS

FOR THE SIX MONTHS ENDED SEPTEMBER 30, 2020 AND SEPTEMBER 30, 2019

(in thousands - unaudited)

 

 

Nine Months Ended
September 30,

 

2020

 

2019

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

Net income

 

$     7,386

 

$     10,369

Adjustments to reconcile net income to net
 cash provided by operating activities

 

 

 

 

Depreciation

 

495

 

526

Amortization

 

4,875

 

4,512

Provision for (recovery of) losses on accounts receivable

 

(4)

 

(2)

Amortization of Right-of-Use Assets

 

29

 

29

(Gain) loss on disposal of assets

 

1

 

-

Deferred income taxes

 

(20)

 

(398)

Stock-based compensation expense

 

121

 

85

Tax benefit attributable to exercise of stock options

 

7

 

20

Changes in operating assets and liabilities:

 

 

 

 

Accounts receivable and other receivables

 

442

 

(1,139)

Inventories

 

757

 

(1,449)

Prepaid expenses and other current assets

 

58

 

73

Accounts payable

 

(439)

 

(188)

Accrued expenses

 

651

 

(1,023)

Total adjustments

 

6,973

 

1,046

Net cash provided by operating activities

 

14,359

 

11,415

 

 

 

 

 

CASH FLOWS FROM INVESTING ACTIVITIES:

 

 

 

 

Capital expenditures for:

 

 

 

 

Property and equipment

 

(806)

 

(252)

Intangible assets

 

-

 

(21,000)

Net cash used in investing activities

 

(806)

 

(21,252)

 

 

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES:

 

 

 

 

Proceeds from issuance of common stock - options

 

282

 

223

Common stock purchased and retired

 

(6,977)

 

(398)

Payment of dividends

 

(3,097)

 

(3,083)

Net cash used in financing activities

 

(9,792)

 

(3,258)

 

 

 

 

 

Effect of exchange rate changes on cash

 

(254)

 

(624)

Net decrease in cash and cash equivalents

 

3,507

 

(13,719)

Cash at beginning of period

 

42,787

 

51,112

Cash at end of period

 

$   46,294

 

$   37,393

 

 

 

 

 

SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:

 

 

 

Cash paid during the period for income taxes

 

$     2,153

 

$     3,957

Cash paid during the period for interest

 

-

 

-

 

 

 

 

see notes to consolidated condensed financial statements

 

 

 

 


3


Table of Contents


UTAH MEDICAL PRODUCTS, INC.

CONSOLIDATED CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY FOR THE

THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2020 AND SEPTEMBER 30, 2019

(In thousands - unaudited)

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

Additional

 

Other

 

 

 

Total

 

Common Stock

 

Paid-in

 

Comprehensive

 

Retained

 

Stockholders'

Shares

 

Amount

 

Capital

 

Income

 

Earnings

 

Equity

Balance at June 30, 2020

3,643

 

$         36

 

$           80

 

$           (11,710)

 

$       106,881

 

$          95,288

Shares issued upon exercise of employee
 stock options for cash

4

 

-

 

202

 

-

 

-

 

202

Stock option compensation expense

-

 

-

 

49

 

-

 

-

 

49

Common stock purchased and retired

(7)

 

-

 

(332)

 

-

 

(219)

 

(551)

Foreign currency translation adjustment

-

 

-

 

-

 

1,511

 

-

 

1,511

Common stock dividends

-

 

-

 

-

 

-

 

(1,018)

 

(1,018)

Net income

-

 

-

 

-

 

-

 

2,933

 

2,933

Balance at September 30, 2020

3,640

 

$         36

 

$           -

 

$           (10,199)

 

$       108,578

 

$          98,415

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2019

3,722

 

$         37

 

$        18

 

$           (9,783)

 

$       110,820

 

$          101,092

Shares issued upon exercise of employee
 stock options for cash

6

 

-

 

282

 

-

 

-

 

282

Stock option compensation expense

-

 

-

 

121

 

-

 

-

 

121

Common stock purchased and retired

(87)

 

(1)

 

(421)

 

-

 

(6,555)

 

(6,976)

Foreign currency translation adjustment

-

 

-

 

-

 

(416)

 

-

 

(416)

Common stock dividends

-

 

-

 

-

 

-

 

(3,074)

 

(3,074)

Net income

-

 

-

 

-

 

-

 

7,386

 

7,386

Balance at September 30, 2020

3,640

 

$         36

 

$           -

 

$           (10,199)

 

$       108,578

 

$          98,415

 

 

 

 

 

 

 

 

 

 

 

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

 

$           -

 

$           (12,490)

 

$       107,439

 

$          94,986

 

 

 

 

 

 

 

 

 

 

 

see notes to consolidated condensed financial statements

 

 

 

 

 

 

 

 

 

 

 


4


Table of Contents


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‑K10-K for the year ended December 31, 2016.2019.  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 March 2016, new

The Company has determined that other recently issued accounting guidance was issued to simplify several aspects of accounting for employee share-based payment (including stock option) transactions, including the accounting for income taxes, forfeitures and statutory tax withholding requirements, as well as classification in the statement of cash flows. Under the guidance, entities recognize all excess tax benefits and tax deficiencies as income tax expense or benefit in the income statement. UTMD adopted this standard on January 1, 2017, which had an insignificantstandards will either have no material impact on its consolidated financial statements. UTMD made a determination to continue to account for forfeitures by estimating the numberposition, results of awards that are expected to vest.  Because UTMD primarily issues incentive stock options, excess tax benefits and tax deficiencies have historically been minimal.


In May 2014, new accounting guidance 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 goodsoperations 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 incurredor will not apply to fulfill a contract.  Entities have the option of using either a full retrospective or a modified retrospective approach for the adoption of the new standard.  This guidance becomes effective for annual reporting periods beginning after December 15, 2017 and early adoption is permitted for periods beginning after December 15, 2016. Because the vast majority of its revenue is recognized when a physical product is shipped, UTMD expects that the 2018 adoption of this standard will have an insignificant impact on its consolidated financial statements, including the timing of revenue recognition.

In February 2016, new accounting guidance 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. This guidance becomes effective for annual reporting periods beginning after December 15, 2018, with early adoption permitted. UTMD has yet to assess the impact that this standard will have on its consolidated financial statements when it is adopted. The only significant lease the Company anticipates it will have at that time is for the parking lot at its Utah facility.

operations.

(3) Inventories at September 30, 20172020, and December 31, 20162019, consisted of the following:


 September 30,  December 31, 
  2017  2016 
Finished goods $982  $1,327 
Work‑in‑process  1,580   942 
Raw materials  2,480   2,273 
Total $5,042  $4,542 

 

September 30, 2020

 

 

December 31, 2019

Finished goods

$

1,446

 

$

1,708

Work-in-process

 

1,387

 

 

1,022

Raw materials

 

3,471

 

 

4,183

Total

$

6,304

 

$

6,913


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(4) Stock-Based Compensation. At September 30, 2017,2020, 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, 20172020, and 2016,2019, the Company recognized $30$49 and $20,$29, respectively, in stock based compensation cost.  In the nine months ended September 30, 20172020, and 2016,2019, the Company recognized $99$121 and $62,$85, 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, 20162019, or September 30, 2017.


2020.


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(6) Fair Value Measurements.Global 3Q 2020 revenues (USD) by product category:

 

 

Domestic

 

 

Outside US

 

 

Total

Obstetrics

 

$

1,032

 

$

247

 

$

1,279

Gynecology/Electrosurgery/Urology

 

 

2,847

 

 

2,202

 

 

5,049

Neonatal

 

 

1,151

 

 

348

 

 

1,499

Blood Pressure Monitoring and Accessories

 

 

1,920

 

 

732

 

 

2,652

Total

 

$

6,950

 

$

3,529

 

$

10,479

Global 9M 2020 revenues (USD) by product category:

 

 

Domestic

 

 

Outside US

 

 

Total

Obstetrics

 

$

2,739

 

$

612

 

$

3,351

Gynecology/Electrosurgery/Urology

 

 

7,686

 

 

6,945

 

 

14,631

Neonatal

 

 

3,266

 

 

1,169

 

 

4,435

Blood Pressure Monitoring and Accessories

 

 

5,215

 

 

2,536

 

 

7,751

Total

 

$

18,906

 

$

11,262

 

$

30,168

(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 Company follows ASC 820, Fair Value Measurementremaining lease term on the parking lot is 11 years and on the automobile it is 16 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 fairthe present value of its financial assets.the leases.

The components of lease cost were as follows:

Three Months Ended September 30, 2020

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, 2020

Weighted Average Remaining Lease Term  - Operating Leases

11 years

Weighted Average Discount Rate – Operating Leases

5.4%

Operating lease liabilities/ payments (in thousands)

Operating lease payments, 2020

$60

Operating lease payments, 2021

$60

Operating lease payments, 2022

$45

Operating lease payments, 2023

$45

Operating lease payments, 2024

$45

Thereafter

$299

Reconciliation of operating lease liabilities/ payments to operating lease liabilities

(in thousands)

Total operating lease liabilities/ payments

$528

Operating lease liabilities – current (included in Accrued Expenses)

$40

Operating lease liabilities – long term

$346

Present value adjustment

$142

Maturities of lease liabilities were as follows:(in thousands)

Maturities of lease liabilities were as follows:

(in thousands)

Year ending December 31,

 

2020

$38

2021

$40

2022

$27

2023

$29

2024

$30

Thereafter

$248


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(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. The following table provides financial assets carried at fair value measured$21,000 purchase price represented an identifiable intangible asset which is being straight-line amortized and recognized as part of G&A expenses over a remaining 3.08 year life as of September 30, 2017:

   Fair Value Measurements Using 
Description
Total Fair Value
at 9/30/2017
 
Quoted Prices
in Active Markets
for Identical Assets
(Level 1)
 
Significant Other
Observable Inputs
(Level 2)
 
Significant
Unobservable Inputs
(Level 3 )
 
Equities $78  $78  $0  $0 


(7)   2020 of the prior CSI distribution agreement with Femcare.

(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 2020.

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,

2020

 

2019

 

2020

 

2019

Numerator

 

 

 

 

 

 

 

Net income

2,933

 

3,705

 

7,386

 

10,369

 

 

 

 

 

 

 

 

Denominator

 

 

 

 

 

 

 

Weighted average shares, basic

3,642

 

3,720

 

3,664

 

3,722

Dilutive effect of stock options

11

 

17

 

14

 

16

Diluted shares

3,653

 

3,737

 

3,678

 

3,738

 

 

 

 

 

 

 

 

Earnings per share, basic

0.81

 

1.00

 

2.02

 

2.79

Earnings per share, diluted

0.80

 

0.99

 

2.01

 

2.77

(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.


5


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Table of Contents


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, 20162019, 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 2017, UTMD achieved results which confirm that the Company is very likely to significantly exceed its previously announced goals for 2017.

Income statement results in 3Q and 9M 20172020 compared to the same periods of 20162019 were as follows:


 3Q 2017  3Q 2016   change   9M 2017  9M 2016  change 
Net Sales $10,125  $9,655   +4.9% $31,213  $30,446   +2.5%
Gross Profit  6,496   5,775   +12.5%  19,925   18,250   +9.2%
Operating Income  4,679   3,939   +18.8%  14,438   12,566   +14.9%
Income Before Tax  4,696   3,980   +18.0%  14,503   12,772   +13.6%
Net Income  3,622   2,935   +23.4%  11,027   9,411   +17.2%
Earnings per Diluted Share  0.969   0.777   +24.7%  2.953   2.493   +18.5%

In contrast

 

3Q 2020

3Q 2019

change

9M 2020

9M 2019

change

Net Sales

$ 10,479

$ 12,494

(16.1%)

$ 30,168

$ 35,073

(14.0%)

Gross Profit

6,497

7,379

(12.0%)

18,283

21,652

(15.6%)

Operating Income

3,588

4,371

(17.9%)

9,428

12,954

(27.2%)

Income Before Tax

3,588

4,448

(19.3%)

9,553

13,150

(27.4%)

Net Income (NI)

2,933

3,705

(20.8%)

7,386

10,369

(28.8%)

Earnings per Diluted Share (EPS)

0.803

0.991

(19.0%)

2.008

2.774

(27.6%)

UTMD management believes that the presentation of sequential 2020 quarterly results provides meaningful supplemental information to prior calendar quarters, UTMD's relative 3Q performance was enhanced byboth management and investors.  Keeping in mind that results for any given three month period in comparison with a weaker USD.  Becauseprevious three month period may not be indicative of comparative results for the initial large impact of BREXIT onyear as a whole, the value offollowing table shows the GBP occurredpercent changes in late 2Q 2016, the change in relative value of the USD2020 quarterly results compared to the GBPsame periods of time in 3Q 2017 compared to 3Q 2016 was minimal.  Revenues2019:

Consolidated Income Statement

1Q

2Q

3Q

9M

Worldwide Revenues

+ 1.6%

(25.8%)

(16.1%)

(14.0%)

Gross Profit

+ 0.9%

(34.0%)

(12.0%)

(15.6%)

Operating Income

( 5.8%)

(55.9%)

(17.9%)

(27.2%)

Earnings Before Income Tax

( 3.6%)

(56.7%)

(19.3%)

(27.4%)

Net Income

-

(62.8%)

(20.8%)

(28.8%)

Earnings Per Share

-

(62.0%)

(19.0%)

(27.6%)

Revenues [USD denominated]

1Q

2Q

3Q

9M

U.S. domestic  (excluding OEM)

+ 14.5%

(29.1%)

(8.0%)

(  9.2%)

Canada domestic

(21.7%)

(62.9%)

( 5.6%)

(32.0%)

Ireland domestic

(26.2%)

(48.6%)

(18.1%)

(30.9%)

UK domestic

(11.2%)

(72.8%)

(34.4%)

(38.7%)

France domestic

(11.8%)

(72.1%)

(12.3%)

(32.6%)

Australia domestic

(  8.6%)

(43.0%)

(13.6%)

(22.0%)

Subtotal, Direct to End User:

+  4.2%

(39.1%)

(11.1%)

(16.3%)

 

All Other OUS (Sales to Int’l Distributors)

 

(  5.2%)

 

(  4.5%)

 

(34.7%)

 

(15.6%)

U.S. OEM Sales

+ 0.7%

+ 9.5%

( 8.9%)

(  0.6%)

Worldwide Revenues

+ 1.6%

(25.8%)

(16.1%)

(14.0%)

UTMD subsidiary direct domestic sales in 3Q 2017 would have been $71 lower usingCanada, Ireland, the sameUnited Kingdom, France and Australia are invoiced in foreign currencies. Foreign currency exchange (FX) rates as in the prior year ("constant dollars"), but because of the effect of BREXIT in first half (1H) 2017 compared to 1H 2016, revenues in 9M 2017 would have been $235 higher in constant dollars. UTMD's FX rates for income statement purposes are transaction-weighted averages. The average rates from the applicable foreign currency to USD during 3Q 20172020 and 9M 20172020 compared to the same periods in 20162019 follow:

  3Q 2017  3Q 2016  Change   9M 2017   9M 2016  Change 
GBP  1.312   1.314   (0.1%)  1.277   1.393   (8.3%)
EUR  1.172   1.118   +4.8%  1.116   1.116   - 
AUD  0.789   0.759   +4.0%  0.766   0.744   +3.0%

UTMD's

 

3Q 20

3Q 19

Change

9M 20

9M 19

Change

GBP

1.295

1.233

+5.0%

1.279

1.273

+0.5%

EUR

1.173

1.108

+5.8%

1.128

1.123

+0.4%

AUD

0.714

0.687

+4.0%

0.677

0.700

(3.3%)

CAD

0.751

0.758

(0.8%)

0.745

0.752

(1.0%)


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Although the volatility of  FX rates for OUS sales when consolidated in USD terms continues to impact period-to-period relative financial results because of UTMD’s significant percentage of foreign currency sales, the FX rate impact in 9M 2020 was less significant than in the recent past. Except for the CAD FX rate which had not changed as significantly as other currencies, a healthy 3Q 2020 decline in the USD offset its strengthening during the first half of the year. Foreign currency revenues in 3Q 2020 were increased by $85 as a result of a weaker USD compared to 3Q 2019.  In contrast, the difference in period-to-period FX rates reduced revenues by $36 in 9M 2020.  Foreign currency sales as a percentage of total sales were 21.0% of total sales in 3Q 2020 and 22.0% of total sales in 9M 2020.  UTMD’s 3Q 2019 and 9M 2019 revenues invoiced in the above foreign currencies represented 27.3%23.6% and 27.2% of total consolidated USD sales respectively.

Other factors that affected period-to-period revenue comparisons included

1)International distributors’ quarter-to-quarter orders fluctuate more than domestic end user orders. 

2)1Q 2019 was a partial quarter of U.S. domestic Filshie Clip System (Filshie device) sales, as the UTMD acquisition of the Cooper Surgical Inc. (CSI) exclusive Filshie device distribution rights took effect February 1, 2019.  

UTMD profit margins in 3Q 20172020 and 24.9%9M 2020 compared to 3Q 2019 and 9M 2019 follow:

 

 

3Q 2020

(Jul – Sep)

3Q  2019

(Jul – Sep)

9M  2020

(Jan – Sep)

9M  2019

(Jan – Sep)

Gross Profit Margin (gross profits/ sales):

62.0%

59.1%

60.6%

61.7%

Operating Income Margin (operating profits/ sales):

34.2%

35.0%

31.3%

36.9%

Net Income Margin (profit after taxes/ sales):

28.0%

29.7%

25.2%

29.6%

Gross Profit in 3Q 2020 declined less than the sales decline primarily as a result of sales mix. The 9M 2020 gross profit margin (GPM), gross profit divided by sales, was lower than in 9M 2017.   UTMD's revenues invoiced2019 despite the better 3Q GPM because 14% lower sales during 9M 2020 absorbed marginally less of UTMD’s fixed critical mass of manufacturing overhead. Because UTMD believes that the lower sales are transitory, knows it can remain very profitable even at the lower sales levels experienced during the pandemic and has a significant cash reserve relative to operational needs, management will not cut important resources and sacrifice future capabilities just to maintain short term profit margins.

Operating Income declined more than gross profit in foreign currencies including CAD represented 34.0%both 3Q 2020 and 9M 2020 because UTMD’s non-cash identifiable intangible asset (IIA) amortization expense included in operating expenses was 15.5% of total consolidated USD sales in 3Q 2017,2020 compared to 12.8% of sales in 3Q 2019, and 32.0%16.0% in 9M 2017.   The weighted average2020 compared to 12.7% in 9M 2019.  This was due not only to the lower sales in 2020 (less absorption of a fixed expense) but also the GBP FX rate for CAD was 0.800 USD/CADdifference in the 3Q 2017, and 0.764 USD/CADthe timing of beginning the CSI IIA amortization in 9M 2017.2019.

Earnings before tax (EBT) declined more than operating income simply because UTMD did not invoice customers in CAD in 2016.


The weighted average positive FX impactreceive interest on GBP, EUR and AUD currency revenues in 3Q 2017 compared to 3Q 2016 was 2.6%, increasing reported USD sales by $71.  The weighted average negative FX impact on GBP, EUR and AUD currency sales in 9M 2017 compared to 9M 2016 was 2.9%, reducing reported USD sales by $235. Total consolidated 3Q 2017 constant currency sales were up 4.1%, and 9M 2017 constant currency sales were up 3.3%, compared to the same periods in 2016.

UTMD's consolidated Gross Profit Margin (GPM), Gross Profit (GP) divided by sales, improved to 64.2% in 3Q 2017 compared to 59.8% in 3Q 2016, and 63.8% in 9M 2017 compared to 59.9% in 9M 2016, primarily due to the 2017 conversion from distributor sales to direct end-user sales of the Filshie Clip System in France and Canada. Consolidated Operating Expenses (OE) were $19 lower in 3Q 2017 compared to 3Q 2016, and $196 lower in 9M 2017 compared to 9M 2016.  Included in G&A OE, the UK amortization of Identifiable Intangible Assets (IIA) expense was about the same in 3Q 2017 but $145 lower in 9M 2017 due to the weaker GBP in first half 2017 compared to first half 2016, accounting for most of the 9M lower OE. The combination of lower OE and higher GPM spurred a 15% increase in 9M 2017 Operating Income (OI) with just a 3% increase in revenues. The 17% higher Net Income (NI) in 9M 2017 was a result of the 15% higher OI plus 1) a reduction in the corporate income tax rate in the UK starting in 2Q 2017, and 2) a lower tax provision in the UK and Ireland based on translation of USDits cash balances in those sovereignties when converted to their respective native currencies.

6

Earnings Per Diluted Share (EPS)2020 like it did in 2019, although average cash balances were about 20% higher during 9M 2017 were up 18%2020.  Net Income declined slightly more than EBT as a result of the 17% higher NI together withsovereignty mix of taxable profits in 2020 compared to 2019.  The lowest tax regimes of Ireland and the UK had the greatest declines in EBT. Finally, Earnings Per Share (EPS) declined less than net income as a result of the benefit of 50,000 shares repurchasedshare repurchases in 4Q 2016.  EPS for the most recent twelve months (TTM) were $3.68.
UTMD profit margins in 3Q 2017 and 9M 2017 compared to 3Q 2016 and 9M 2016 follow:
  
3Q 2017
(Jul-Sep)
  
3Q 2016
(Jul-Sep)
  
9M 2017
(Jan-Sep)
  
9M 2016
(Jan-Sep)
 
Gross Profit Margin (gross profit/ sales):  64.2%  59.8%  63.8%  59.9%
Operating Income Margin (operating income/ sales):  46.2%  40.8%  46.3%  41.3%
EBT Margin (profit before income taxes/ sales):  46.4%  41.2%  46.5%  42.0%
Net Income Margin (profit after taxes/ sales):  35.8%  30.4%  35.3%  30.9%

UTMD's Balance Sheet continued to strengthen. September 30, 2017 ending Cash and Investments were up $11.2 million, and Stockholders' Equity was up $12.0 million, from December 31, 2016.2020.

UTMD’s FX rates for Balance Sheetbalance sheet purposes are the applicable rates at the end of each reporting period. The FX rates from the applicable foreign currenciescurrency to USD for assets and liabilities at the end of September 20172020 and the end of September 20162019 follow:


  SEP 30, 2017  SEP 30, 2016  change 
GBP  1.340   1.301   +3.0%
EUR  1.181   1.124   +5.1%
AUD  0.784   0.767   +2.3%
CAD  0.799   0.762   +4.9%

b)Revenues

The Company believes that revenue should be recognized at the time

 

Sep 30, 2020

Sep 30, 2019

Change

GBP

1.292

1.230

+5.0%

EUR

1.172

1.091

+7.5%

AUD

0.716

0.675

+6.1%

CAD

0.751

0.755

(0.6%)

UTMD’s September 30, 2020 Balance Sheet remained strong with an absence of shipment as title generally passesdebt. During 2020, inventories declined $0.6 million despite much lower sales, which is an indication of good manufacturing planning and control. Due to the customer atincrease in value of the timeGBP, EUR and AUD noted above, despite depreciation of shipment, or completionfixed assets, the USD net book value of services performed under contract.  Revenue recognized by UTMD is based upon documented arrangementsfixed assets in the UK, Ireland and fixed contracts in whichAustralia increased $0.6 million as of September 30, 2020 from September 30, 2019. Over the selling price is fixed prior to acceptance and completionone year period of an order.  Revenue from product or service sales is generally recognized at the time, the productintangible asset balance declined $5.5 million, about 12%.  Ending cash and investments were $46.3 million on September 30, 2020 compared to $42.8 million on December 31, 2019, after paying $3.1 million in cash dividends to stockholders and repurchasing $7.0 million in UTMD stock during 9M 2020.  After reducing stockholders’ equity a combined $10.1 million in 9M 2020 stockholder dividends and share repurchases, September 30, 2020 stockholders’ equity was down only $2.7 million from December 31, 2019.


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Table of Contents


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’s various contracts with customers and associated performance obligations and the Company’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 shipped or service completedconfident that the Company has properly evaluated the standard’s requirements and invoiced,has arrived at appropriate conclusions in recognizing revenue in accordance with the new standard.  Those practices and collectibility is reasonably assured.  Over 99% of UTMD'sprocedures the Company will use to recognize revenue isunder the new standard are not significantly different than the methods used previously since UTMD has traditionally recognized at the time UTMD shipsrevenue upon shipping a physical medical deviceproduct to a customer, orwhich 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’s revenue not associated with shipping a customer's designated inventory location, where the selling price for the item shipped was agreed prior to UTMD's acceptance and completion of the customer order. There are no post-shipment obligations which have been or are expected to be material to financial results.


There are circumstances under which revenue may be recognized whenphysical product is not shipped, which meetimmaterial, management believes the criteria of SAB 104:  the Company provides engineering services, for example, design and production of manufacturing toolingCompany’s practices in recognizing that may be used in subsequent UTMD manufacturing of custom components for other companies.  This revenue is recognized when UTMD's service has been completed according to a fixed contractual agreement.

also in accordance with ASU 2014-09.

Terms of sale are established in advance of UTMD'sUTMD’s acceptance of customer orders.  In the U.S., Canada, Ireland, UK, France, Canada and Australia, UTMD generally accepts orders directly from and ships directly to end user clinical facilities, as well as third party med/surgmedical/surgical distributors, under UTMD'sUTMD’s Standard Terms and Conditions (T&C) of Sale. About 14% of UTMD's U.S.UTMD’s domestic end user sales, excluding Filshie device sales, 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 ofof Sale to end user facilities are substantially the same in the U.S., Canada, Ireland, UK, France, Canada and Australia.  In other geographic regions, UTMD sells its devices to third party distributors which then distribute the devices to medical facilities within their designated territories. UTMD's T&C of Sale for its international distributors are substantially the same.

7

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. Except on rare occasions such as when customers do not meet prepayment agreements, pricesPrices 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 above that the selling price is fixed prior to the acceptance of a specific customer order.


Total consolidated 3Q 2017 consolidated2020 UTMD sales were $471 (4.9%$2,016 (16.1%) higherlower than in 3Q 2016, and in2019. Constant currency sales were $2,101 (16.8%) lower. Total consolidated 9M 20172020 UTMD sales were $768 (2.5%$4,905 (14.0%) higherlower than in 9M 2016.  Comparing2019.  Constant currency sales in 9M 2020 were $4,869 (13.9%) lower than in 9M 2019.

In 3Q 20172020 compared to 3Q 2016, total2019, U.S. domestic sales were about the same8% lower and USDOUS sales outside the U.S. (OUS sales) were 10% higher. Comparing28% lower.   In 9M 20172020 compared to 9M 2016, total2019, U.S. domestic sales were 3% higher7% lower and OUS sales were 2% higher.


U.S. domestic sales were 0% ($8) higher in 3Q 2017 than in 3Q 2016, and 3% ($443) higher in 9M 2017 than in 9M 2016.  23% lower.  

Domestic sales were 49% of total consolidated sales in 3Q 2017 and 51%2020 were $6,950 compared to $7,575 in 3Q 2016, and 49%2019.  Domestic sales in both 9M 2017 and2020 were $18,906 compared to $20,366 in 9M 2016. Sales2019.  The components of Femcare'sdomestic sales include 1) “direct sales” of UTMD’s medical devices to user facilities (and med/surg stocking distributors for hospitals), excluding Filshie Clip System (“Filshie device”) 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 direct to CooperSurgical Inc. (CSI) for distributionU.S. medical facilities starting in the U.S. were $264 higherFebruary 2019.  

Domestic direct sales in 3Q 2017 compared to 3Q 2016, and $594 higher in 9M 2017 compared to 9M 2016.  CSI purchases included, for the first time, $159 in 3Q 2017 and $244 in 9M 2017 of2020 excluding Filshie Sterishot kits which incorporate single use applicators approved by the FDA in December 2016. Femcare's sales to CSI were 13%devices, representing 50% of total domestic sales, were $178 (5%) lower than in 3Q 2017 compared to 8%2019.  Domestic direct sales in 9M 2020 excluding Filshie devices, representing 51% of total domestic sales, were $1,078 (10%) lower than in 9M 2019. OEM sales in 3Q 2016, and 20%2020, representing 25% of total domestic sales, were $172 (9%) lower than in 3Q 2019. OEM sales in 9M 2017 compared to 16%2020, also representing 25% of total domestic sales, were $27 (1%) lower than in 9M 2016. Domestic OEM2019. Filshie device sales were $32 higher in 3Q 2017 compared to 3Q 2016, and $95 higher in 9M 2017 compared to 9M 2016. Direct salesdirect to U.S. userdomestic end-user facilities were $287$275 (14%) lower in 3Q 20172020 compared to sales in 3Q 2016, and $2462019.  Filshie device sales direct to U.S. domestic end-user facilities were $355 (7%) lower in 9M 20172020 compared to Filshie device sales in 9M 2016. All2019.  Because Filshie device sales are a significant portion of UTMD’s domestic business and a UTMD device most affected by the lowerCOVID-19 pandemic, management believes the following table might help to see the overall 2020 pandemic impact and recovery trend:

Filshie device sequential quarterly USD domestic direct sales were due to a weaker third quarter order pattern from U.S. hospitals in all product categories, partly due to one less shipping day, partly from the effects of hurricanes in the U.S., partly resulting from an end

Year

1Q

2Q

3Q

9M

2020

1,689

1,135

1,733

4,557

2019

925

1,979

2,008

4,912


11


Table of 3Q 2017 delivery glitch by UTMD's sterilizer, and partly related to a larger volume of late orders that didn't ship until the beginning of October (resulting in a larger than normal 4Q 2017 beginning backlog).


OUS sales consolidated in USD in 3Q 2017 were 10% ($462) higher than in 3Q 2016, and 2% ($325) higher in 9M 2017 than in 9M 2016. In 9M 2017, UTMD lost $235 in OUS sales due to a weaker GBP. In other words, constant dollar OUS sales were 4% ($560) higher in 9M 2017 compared to 9M 2016. 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 25% of total Contents


OUS sales in 3Q 20172020 were $3,528 compared to 24%$4,919 in 3Q 2016, and 24% in both 9M 2017 and 9M 2016. Australia subsidiary USD sales were 11% of total2019.  OUS sales in both 3Q 2017 and 9M 20172020 were $11,262 compared to 12%$14,707 in 9M 2019.

OUS sales invoiced in GBP, EUR, AUD and CAD currencies were $85 higher in 3Q 20162020 and 11%$36 lower in 9M 2016.  Ireland subsidiary USD trade sales were 26%2020 as a result of totalchanges in FX rates. Foreign currency OUS sales in 3Q 2017 compared to 37% in 3Q 2016,2020 were $2,205, which was 62% of all OUS sales and 25% in 9M 2017 compared to 36% in 9M 2016. Canada subsidiary USD sales were 13%21% of total consolidated sales.  In comparison, foreign currency OUS sales in 3Q 2017 and 14% in 9M 2017 compared to 0% in 2016.


The lower portion2019 were $2,944, which was 60% of OUS trade sales by Ireland was due primarily to the conversion from Ireland selling Filshie Sterishot kits to Canada and France distributors in 2016 (trade sales) to selling to other UTMD subsidiaries (Utah Medical Products Canada, Inc and Femcare Ltd) for direct distribution into Canada and France (intercompany sales) in 2017. Included in the Femcare UK sales were the direct sales to end users in France which comprised 7% ofall OUS sales in 3Q 2017 and 6%24% of total consolidated sales.  

The foreign currency OUS sales in 9M 2017.


2020 were $6,653, which was 59% of all OUS sales and 22% of total consolidated sales.  In comparison, foreign currency OUS sales in 9M 2019 were $9,534, which was 65% of all OUS sales and 27% of total consolidated sales.  Because Filshie device sales are also a significant portion of UTMD’s OUS business and an implanted device most affected by the COVID-19 pandemic, management believes the following table might help to see the overall 2020 pandemic impact and recovery trend:

Filshie device OUS sequential quarterly USD-denominated sales:

 

Year

1Q

2Q

3Q

9M

Direct

2020

1,798

681

1,426

3,905

 

2019

2,135

2,036

1,810

5,981

Distributor

2020

318

323

133

774

 

2019

494

487

437

1,418

Total OUS

2020

2,117

1,003

1,559

4,679

 

2019

2,630

2,523

2,246

7,399

OUS Filshie sales obviously took a deeper hit from the pandemic than in the U.S.

UTMD segments sales into the following general product categories:  gynecology/ electrosurgery, labor & delivery, neonatal, and miscellaneous including blood pressure monitoring kits and accessories as well as related OEM products.  

In 3Q 2020 compared to 3Q 2019, worldwide gynecology/ electrosurgery device sales were down 21%, worldwide labor & delivery device sales were essentially the same, worldwide neonatal device sales were down 6% and worldwide blood pressure monitoring and related OEM product sales were down 18%.  Devices in the gynecology/ electrosurgery category were mostly classified as “nonessential” during the pandemic.  In the blood pressure monitoring category, UTMD’s largest OUS distributor took a double quarterly shipment in 3Q 2019.

In 9M 2020 compared to 9M 2019, worldwide gynecology/ electrosurgery device sales were down 22%, worldwide labor & delivery device sales were down 13%, worldwide neonatal device sales were down 2% and worldwide blood pressure monitoring and related OEM product sales were down 3%.

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


Global 3Q 2020 revenues (USD) by product category:

  3Q 2017  3Q 2016   9M 2017   9M 2016 
Obstetrics $1,218  $1,229  $3,372  $3,428 
Gynecology/ Electrosurgery/ Urology  5,529   4,978   17,473   16,170 
Neonatal  1,510   1,402   4,574   4,575 
Blood Pressure Monitoring and Accessories*  1,868   2,046   5,794   6,273 
Total: $10,125  $9,655  $31,213  $30,446 
8

OUS

 

Domestic

Outside US

Total

Obstetrics

$   1,032

$      247

$   1,279

Gynecology/Electrosurgery/Urology

2,847

2,202

5,049

Neonatal

1,151

348

1,499

Blood Pressure Monitoring and Accessories*

1,920

732

2,652

Total:

$   6,950

$   3,529

$ 10,479

Global 9M 2020 revenues (USD) by product category:

  3Q 2017  3Q 2016   9M 2017   9M 2016 
Obstetrics $172  $185  $533  $499 
Gynecology/ Electrosurgery/ Urology  3,691   3,197   10,966   10,024 
Neonatal  543   323   1,540   1,512 
Blood Pressure Monitoring and Accessories*  805   1,044   2,746   3,426 
Total: $5,211  $4,749  $15,785  $15,461 

 

Domestic

Outside US

Total

Obstetrics

$   2,739

$      612

$   3,351

Gynecology/Electrosurgery/Urology

7,686

6,945

14,631

Neonatal

3,266

1,169

4,435

Blood Pressure Monitoring and Accessories*

5,215

2,536

7,751

Total:

$ 18,906

$ 11,262

$ 30,168

*includes molded components sold to OEM customers.


Looking forward, although an increase in COVID-19 infections is likely in the winter months of 4Q 2020 in the northern hemisphere, assuming no significant new lockdowns or prohibitions of “nonessential procedures” are imposed by governments, UTMD expects that its 4Q 2020 sales in 4Q 2017 comparedwill continue to 4Q 2016 are expected to grow morerecover and be higher than they did in 3Q 2017 compared to 3Q 2016, for several reasons: 1) 4Q 2016 was UTMD's lowest sales quarter in 2016; 2) a higher than usual 4Q 2017 beginning backlog; 3) the CSI committed 4Q 2017 order indicates 47% higher Filshie Clip System purchases than in 4Q 2016; 4) a continued weaker USD is expected to have a favorable impact on foreign currency consolidated sales; and 5) Bayer has announced that the Essure, the Filshie Clip System's chief competing surgical permanent contraception device, will no longer be sold OUS.


2020.  


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c)Gross Profit (GP)


GP

Gross Profit results from subtracting the costcosts of manufacturing and shipping products to customers (direct materials, direct labor, manufacturing overhead and shipping costs), or the purchase price of distributed finished products manufactured by other companies, from revenues.  At UTMD, manufacturing overhead costs fully absorb indirect costs including depreciation of manufacturing equipment and facilities, quality assurance, materials requirements planning and purchasing, manufacturing engineering, production supervision, shipping, royalties paid to other entities and health plan benefits for both direct and indirect manufacturing personnel.  UTMD's consolidated GPGross Profit was $883 (12.0%) lower in 3Q 2017 was $721 higher2020 than in 3Q 2016, while sales were only $471 higher. UTMD's2019, and $3,369 (15.6%) lower in 9M 2017 GP was $1,675 higher2020 than in 9M 2016, while sales2019.  UTMD’s 3Q 2020 GPM improved to 62.0% compared to 59.1% in 3Q 2019 so that the decline in 3Q Gross Profit was not as significant as the 3Q decline in sales. Sales to international distributors are at lower prices for the same devices because the distributor incurs direct marketing expenses instead of UTMD.  Sales to international distributors were only $768 higher. The higher GPMs in 2017 resulted essentially from direct18% of total sales in Canada3Q 2020 compared to 23% in 3Q 2019. The 3Q 2019 GPM was also exceptionally low because of a “double” shipment of blood pressure monitoring kits to UTMD’s China distributor. For 9M 2020 compared to 9M 2019, Gross Profit declined slightly more than the sales decline as a result of UTMD not cutting critical manufacturing overhead resources, and France at retail prices which replaced distributor sales at wholesale pricesproviding special incentives in 2Q 2020 for employees to come to work. Nevertheless, the prior year.


60.6% GPM for the 2020 year to date has met management’s long term objective.  

d)Operating Income (OI)


OI is GP minus OE.  Due to higher GP and lower OE, OI in 3Q and 9M 2017 was $4,679 and $14,438 respectively, compared to $3,939 and $12,566 in 3Q and 9M 2016 respectively. UTMD's 3Q and 9M 2017 continued excellent OIM was 46.2% and 46.3% respectively, compared to 40.8% and 41.3% in the same periods of 2016.

OE are

Operating Income results from subtracting Operating Expenses from Gross Profit. Operating Expenses, comprised of general and administrative (G&A) expenses, sales and marketing (S&M) expenses and product development (R&D) expenses. Consolidated USD-denominated OEexpenses, were $1,81727.8% of sales in 3Q 2017 (17.9% of consolidated revenues)2020 compared to $1,83624.1% of sales in 3Q 2016 (19.0%2019.  Operating Expenses were 29.4% of consolidated revenues). Holding OE relatively constant while increasing sales added leveragein 9M 2020 compared to 24.8% of sales in 9M 2019. Although the operating expense percentage of sales increased due to the 12.5% increase2020 short term pandemic reduction in GPsales, management continued to tightly manage operating expenses without sacrificing resources needed for longer term growth.

Summary comparison of (USD) consolidated operating expenses:

 

3Q 2020

3Q 2019

9M 2020

9M 2019

S&M Expense

$  352

$  421

$  1,195

$  1,304

R&D Expense

125

130

375

357

G&A Expense

2,432

2,457

7,285

7,037

Total Operating Expenses:

$  2,909

$  3,008

$  8,855

$  8,698

Lower S&M expenses were due primarily to the lack of trade show expenses during the pandemic. S&M expenses were 3.4% of sales in achieving UTMD's 18.8% increase inboth 3Q 2017 OI.  Consolidated OE2020 and 3Q 2019.  S&M expenses were $5,4874.0% of sales in 9M 2017 (17.6% of revenues)2020 compared to $5,6843.7% of sales in 9M 2016 (18.7% of revenues), helping to leverage a 9.2% increase in GP into a 14.9% increase in OI for 9M 2017.


Consolidated S&M expenses in 3Q 2017 were $364 (3.6% of sales) compared to $408 (4.2% of sales) in 3Q 2016, and were $1,154 (3.7% of sales) in 9M 2017 compared to $1,270 (4.2% of sales) in 9M 2016.  Consolidated S&M expenses declined despite an increase in S&M expenses for the new Canada subsidiary of $17 in 3Q 2017 and $48 in 9M 2017. The lower overall S&M expenses resulted from not replacing a few sales employees as quickly as planned, and increased operating efficiencies in customer service and marketing.  In 2017, UTMD was able to begin marketing directly to medical facility end users in France without expanding preexisting UK S&M personnel.

S&M expenses include all customer support costs including training. In general, training is not required for UTMD's medical devices since they are well-established and have been clinically widely used. Written "Instructions For 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 UK 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.  Historically, marginal consulting costs have been immaterial to financial results.
9

2019.   

R&D expenses were $103 (1.0%consistent with the prior year’s same periods of sales) in 3Q 2017 compared to $135 (1.4% of revenues) in 3Q 2016. In 9M 2017,time, varying only by specific project expenses. R&D expenses were $341 (1.1%1.2% of revenues)sales in 3Q 2020 compared to $364 (1.2%1.0% of revenues)sales in 3Q 2019.  R&D expenses in 9M 2016. Variations2020 were also 1.2% of sales compared to 1.0% of sales in R&D expenses result from costs9M 2019.    

The higher G&A expense in 9M 2020 was due to amortization expense of projects, including engineering time,the CSI IIA for a full quarter in different stages of completion.  At UTMD, R&D engineers also devote much of their time1Q 2020 compared to manufacturing process improvements.


a partial quarter in 1Q 2019.  Consolidated G&A expenses were $1,350 (13.3%23.2% of sales)sales in 3Q 20172020 compared to $1,293 (13.4%19.7% of sales)sales in 3Q 2016, and2019.  Consolidated G&A expenses were $3,993 (12.8%24.1% of sales)sales in 9M 20172020 compared to $4,050 (13.3%20.1% of sales)sales in 9M 2016. A weaker GBP in the first half of the year helped lower 9M 2017 amortization of IIA resulting from the Femcare acquisition, which are part of G&A expenses, by $145. To be more clear, consolidated2019.  G&A expenses included non-cash expense from the amortization of IIA resulting from the March 2011 Femcare Group Ltd (UK) acquisition and the amortization of IIA from the purchase of the CSI U.S. exclusive Filshie devices distribution rights effective in February 2019.  

The initial amount of IIA for the 2011 Femcare UK purchase was £23,998.  After 9.5 years of amortization, the IIA balance is £8,686.  For both years of 2020 and 2019, the amortization expense rate was a constant £399 per calendar quarter. The USD amortization expense amount in each period, however, varied according to the USD/GBP FX rate.

The initial amount of IIA for the 2019 acquisition of $522 (5.2%4.75 years’ remaining exclusive U.S. Filshie device distribution rights from CSI was $21,000.  The straight-line amortization of consolidated revenues) in 3Q 2017 and $1,526 (4.9%this IIA is $1,105/ calendar quarter over the remaining 4.75 years of consolidated revenues)the prior distribution agreement. After 20 months of amortization, the CSI IIA balance as of September 30, 2020 is $13,632.  The difference in 9M 2017, compared to $524 (5.4% of consolidated revenues) in 3Q 2016 and $1,671 (5.5% of consolidated revenues) in 9M 2016. The period to period differences in USD-denominatedCSI IIA amortization expense were almost all FX-related sinceis due to the start of the amortization in February 2019, i.e. 9 months of expense in 2020 through September versus 8 months in 2019.


13


Table of Contents


Because the IIA amortization expense was £1,196 in 9M 2017 compared to £1,201 in 9M 2016.expenses represent a significant portion of UTMD’s G&A expenses, excludingUTMD provides the noncashfollowing table that separates the IIA amortization expenses from all other G&A expenses:

 

3Q 2020

3Q 2019

9M 2020

9M 2019

IIA amortization expense

$  1,621

$  1,597

$  4,839

$  4,471

All other G&A expense

811

860

2,445

2,566

Total G&A Expenses:

$  2,432

$  2,457

$  7,284

$  7,037

Percent of Sales:

3Q 2020

3Q 2019

9M 2020

9M 2019

IIA amortization expense

15.5%

12.8%

16.0%

12.8%

All other G&A expense

7.7%

6.9%

8.1%

7.3%

Total G&A Expenses:

23.2%

19.7%

24.1%

20.1%

Eventually, when the two Filshie-related IIA balances are fully amortized, stockholders can look forward to a substantial increase in EBT. The Femcare acquisition IIA amortization expense were $828 (8.2% of revenues)has 5.5 more years to run at about $516 per quarter using the same 1.295 USD/GBP FX rate as in 3Q 2017 compared to $770 (8.0% of revenues) in 3Q 2016.2020.  The increase in 3Q 2017 was due to $44 in G&A expense for the new Canada subsidiary and a stronger EUR which increased Ireland G&A expenses in USD terms.  G&A expenses excluding the noncashCSI IIA amortization expense has 3.1 more years to run at $1,105 per quarter.  Stockholders will appreciate that, although cash flow will not be affected, annualized reported EPS will increase $.90 after another 3.1 years, based on current shares outstanding and if current U.S. and Utah income tax rates remain the same. Similarly, after another 5.5 years annualized EPS would be $1.36 higher based on current shares outstanding and unchanged income tax rates.  

Other G&A expenses were $2,467 (7.9%lower in both periods primarily because UTMD’s CEO has taken 50% salary in 2020 compared to 2019, and 2020 management bonuses based on the projected 2020 annual EBT have been accrued at a lower rate than in 2019.

In summary, Operating Income in 3Q 2020 was $3,588 (34.2% of revenues)sales) compared to $4,371 (35.0% of sales) in 3Q 2019.  Operating Income in 9M 20172020 was $9,428 (31.3% of sales) compared to $2,379 (7.8%$12,954 (36.9% of revenues)sales) in 9M 2016.  Again,2019.  Lower gross profits in 2020 were leveraged down further by higher IIA amortization expense absorbed by fewer sales. In any event, the increase was due to G&A expenses for the new Canada subsidiary, which added $142 to consolidated G&A expensesoperating income margins achieved in 9M 2017.


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 $30 in 3Q 20172020 were excellent compared to $20 in 3Q 2016, and $99 in 9M 2017 compared to $62 in 9M 2016.

Summary comparison of (USD) consolidated operating expenses:
  3Q 2017  3Q 2016   9M 2017   9M 2016 
S&M Expense $364  $408  $1,154  $1,270 
R&D Expense  103   135   341   364 
G&A Expense  1,350   1,293   3,993   4,050 
Total Operating Expenses: $1,817  $1,836  $5,487  $5,684 

industry peers.

e)Non-operating expense/ Non-operating income 

Non-operating expense (NOE)/ Non-operating income (NOI)


NOE/NOI includes the combination of 1) expenses from loan interest and bank fees; 2) expenses or income from losses or gains 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 cash deposit balances; 2) rent of underutilized property, investment income andproperty; 3) royalties received from licensing the Company's technology. Negative NOE is NOI.  Net NOICompany’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.  

UTMD’s net non-operating income in 3Q 20172020 was $17less than $1 compared to $41$76 in 3Q 2016.2019.  Net NOInon-operating income in 9M 20172020 was $65$126 compared to $206$196 in 9M 2016.  A gain on remeasured2019.      

In 3Q 2020 and 3Q 2019, gains or losses from remeasurement of the value of foreign currency bank balances in 3Q 2017 was $4were negligible. In 9M 2020, UTMD recognized a $41 gain from remeasurement of the value of foreign currency bank balances compared to a gain of $18 in 3Q 2016.  In 9M 2017, a gain on remeasured foreign currency balances was $5 compared to a gain of $129$44 loss in 9M 2016.2019.  Royalties received were $23$5 in 3Q 20172020 compared to $22$0 in 3Q 2016,2019, and $65$10 in 9M 20172020 compared to $67$6 in 9M 2016.


2019. Interest earned on cash balances were $2 and $64 in 3Q and 9M 2020 respectively, compared to interest of $61 and $199 in 3Q and 9M 2019 respectively.  

f)Income Before Income Taxes (EBT)


Consolidated

EBT results from subtracting net NOEnon-operating expense or adding NOInet non-operating income from or to, as applicable, consolidated OI.Operating Income.  Consolidated 3Q 20172020 EBT was $4,696 (46.4%$3,588 (34.2% of sales) compared to $3,980 (41.2%$4,448 (35.6% of sales) in 3Q 2016.2019.  Consolidated 9M 20172020 EBT was $14,503 (46.5%$9,553 (31.7% of sales) compared to $12,772 (42.0%$13,150 (37.5% of sales) in 9M 2016.


2019.   

The EBT of Utah Medical Products, Inc. (U.S. only)in the U.S. was $2,331$6,469 in 3Q 20179M 2020 compared to $2,347 in 3Q 2016, and $6,815$8,674 in 9M 2017 compared to $6,750 in 9M 2016.2019. The EBT of Utah Medical Products, Ltd (Ireland) was EUR 7172,393 in 3Q 20179M 2020 compared to EUR 855 in 3Q 2016, and EUR 2,2292,157 in 9M 2017 compared to EUR 2,455 in 9M 2016 . The lower 2017 EBT in Ireland was due to Ireland selling its manufactured Filshie Sterishot kits on a discounted intercompany basis to UTMD Canada and UTMD UK for distribution directly into France, instead of selling on a wholesale trade basis to external distributors distributing Filshie devices in Canada and France.  The trade-off to lower Ireland EBT was higher UK subsidiary trade revenues and profits, and new revenues and profits by UTMD Canada.2019. The EBT of Femcare Group Ltd (Femcare-Nikomed,(Femcare Ltd., UK and Femcare Australia)Australia Pty Ltd) was GBP 835(297) in 3Q 20179M 2020 compared to GBP 566 in 3Q 2016, and GBP 3,1411,449 in 9M 2017 compared to GBP 2,374 in2019. The 9M 2016.  The 3Q 2017 and 9M 20172020 EBT of Utah Medical Products Canada, Inc. (dba Femcare Canada) was CAD 435 and CAD 1,497, respectively,565 in 9M 2020 compared to zeroCAD 926 in 2016.

10

Excluding9M 2019.  The EBT of UTMD’s manufacturing subsidiaries varies as a result of intercompany shipments which are eliminated in the noncashconsolidation of results.


14


Table of Contents


EBITDA is a non-US GAAP metric that UTMD management believes is of interest to investors because it provides meaningful supplemental information to both management and investors that represents profitability performance without factoring in effects of depreciation, amortizationfinancing, accounting decisions regarding non-cash expenses, capital expenditures or tax environments. Although the U.S. Securities and Exchange Commission advises that EBITDA is a non-GAAP metric, UTMD’s non-US GAAP EBITDA is the sum of intangible assets and stock option expense, 3Q 2017 consolidated EBT excluding the remeasured bank balance currency gain or loss and interest expense (adjusted consolidated EBITDA) were $5,417 (53.5%following elements in the table below, each of sales) compared to $4,670 (48.4%which is a US GAAP number:

Component of EBITDA

3Q 2020

3Q 2019

Change

9M 2020

9M 2019

Change

EBT

$  3,588

$  4,448

(19.3%)

$ 9,553

$13,150

(27.4%)

Depreciation of fixed assets

160

171

 

495

526

 

Amortization of patent expenses

13

13

 

37

41

 

Amortization of Femcare IIA

516

492

 

1,523

1,524

 

Amortization of CSI distribution agreement  IIA

1,105

1,105

 

3,316

2,947

 

Stock option compensation expense

49

29

 

121

85

 

Remeasured currency (gains) or losses

2

(3)

 

(41)

44

 

Adjusted Consolidated EBITDA:

$ 5,433

$ 6,255

(13.2%)

$15,004

$18,317

(18.1%)

Management believes that the non-US GAAP EBITDA decline is more indicative of sales) in 3Q 2016. Adjusted consolidated EBITDA in 9M 2017 were $16,653 (53.4% of sales) compared to $14,871 (48.8% of sales) in 9M 2016. Basedthe COVID-19 negative impact on this 9M performance, management now projects approximately $21.5 million in adjusted consolidated EBITDA forUTMD’s 2020 operating results than the 2017 year.  TTM adjusted consolidated EBITDA were $21,000.


change represented by EBT.

g)Net Income (NI)


NI

Net Income is EBT minus a provision for income taxes.  NINet Income in 3Q 2017 of $3,622 (35.8%2020 was $2,933 (28.0% of sales) was $686 (+23.4%) higher than the NI of $2,935 (30.4%compared to $3,705 (29.7% of sales) in 3Q 2016.  In addition to the 18.0% growth in EBT, NI in 3Q 2017 was further leveraged by a lower accrued income tax provision.2019.    The average consolidated income tax provision rate(as a % of EBT) in 3Q 20172020 was 22.9%18.3% compared to 26.3% for16.7% in 3Q 2016.  NI2019.

Net Income in 9M 2017 of $11,027 (35.3%2020 was $7,386 (24.5% of sales) was $1,616 (+17.2%) higher than the NIcompared to Net Income of $9,411 (30.9%$10,369 (29.6% of sales) in 9M 2016.2019.  Net Income in 9M 2020 included a 2Q 2020 unfavorable $225 tax provision increase for a future UK income tax increase on non-deductible IIA amortization expense over the next six years.  The average consolidated income tax provision rates were 24.0%provisions (as a % of EBT) in 9M 20172020 and 26.3% in 9M 2016.  On April 1, 2017, the corporate income tax rate in the UK was lowered from 20% to 19%. For foreign subsidiaries, the tax provision booked in consolidated results is based on taxable income in the applicable sovereignty, not based on U.S. GAAP EBT.  As UTMD held about $19 million in cash in USD currency in Ireland2019 were 22.7% and UK subsidiary bank accounts as of September 30, 2017, and the USD weakened relative to the applicable native currency, the resulting translation loss for each subsidiary created a tax credit for those subsidiaries. In summary, although there was not a corresponding translation loss for consolidated UTMD EBT results, which are obviously expressed in USD, there was an income tax provision benefit.


21.1%, 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).

Diluted EPS in 3Q 20172020 were $0.969$.803 compared to $0.777$.991 in 3Q 2016.  In2019.  Diluted EPS in 9M 2017, diluted2020 were $2.008 compared to $2.774 in 9M 2019.  According to U.S. GAAP, the UK tax law change in 2Q 2020 which increased UTMD’s deferred tax liability, to be amortized over the next six years, was recognized as an income tax provision increase in the 2Q 2020 income statement. Without the 2Q 2020 $225 tax provision adjustment, 9M 2020 EPS were $2.953$2.069.  

Diluted shares were 3,653,500 in 3Q 2020 compared to $2.4933,737,335 in 3Q 2019, and 3,678,210 in 9M 2016.  With some help from2020 compared to 3,738,056 in 9M 2019.  The lower diluted shares outstanding, 3Q 2017 EPS increased 24.7% (19.2 cents) compared to 3Q 2016, andin 9M 2017 EPS increased 18.5% (46.0 cents) compared to 9M 2016.


Diluted2020 were the combined result of 80,000 shares outstanding used to calculate 3Q 2017 EPS were 3,738,190 compared to 3,777,537repurchased in 1Q 2020, 7,000 shares repurchased in 3Q 2016.  The number of shares added as a dilution factor in 3Q 2017 was 19,300 compared to 16,837 in 3Q 2016. Diluted shares outstanding used to calculate 9M 2017 EPS were 3,734,102 compared to 3,775,1662020, 5,614 employee option exercises in 9M 2016.  The number2020 and an employee option award of shares added as a dilution factor in 9M 2017 was 17,647 compared to 17,885 in 9M 2016. Although UTMD has not to date in 2017 repurchased any of its26,300 shares in the open market, in 4Q 2016 UTMD repurchased 50,000 shares which reduced outstanding shares in 9M 2017 compared to 9M 2016.

March 2020.

Outstanding shares at the end of 3Q 20172020 were 3,719,328 which included 9M 20173,640,371 compared to 3,721,757 at the end of calendar year 2019. The difference was due to employee and outside director option exercises of 6,409 shares.5,614 during 9M 2020 offset by 87,000 shares repurchased in the open market. Outstanding shares were 3,720,344 one year ago at the end of 3Q 2019. The number of shares used for calculating earnings per sharediluted EPS 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, 20172020 was 57,019 shares71,700 at an average exercise price of $45.35/$65.80, including shares awarded but not yet vested.  This compares to 51,690 unexercised option shares at the end of 2019 at an average exercise price of $58.50/ share, including shares awarded but not yet vested. This compares


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The number of shares added as a dilution factor in 3Q 2020 was 11,130 compared to 49,398 unexercised17,588 in 3Q 2019. The number of shares added as a dilution factor in 9M 2020 was 14,514 compared to 16,435 in 9M 2019.  In March 2020, 26,300 option shares outstandingwere awarded to 48 employees at September 30, 2016, at an average exercise price of $39.55/$77.05 per share. No option shares have beenoptions were awarded in 2019.  UTMD paid $1,020 ($0.280/share) in dividends to datestockholders in 2017.


During both3Q 2020 compared to $1,028 ($0.275/ share) paid in 3Q 2019. Dividends paid to stockholders during 3Q 2020 were 35% of 3Q 2020 Net Income.  UTMD paid $3,097 ($0.280/share) in dividends to stockholders in 9M 2017 and2020 compared to $3,083 ($0.275/ share) paid in 9M 2016,2019. Dividends paid to stockholders during 9M 2020 were 41% of 9M 2020 Net Income.   

In March 2020, UTMD did not repurchaserepurchased 80,000 of its shares in the open market.market at $80.32/ share. In September 2020, UTMD repurchased 7,000 of its shares in the open market at $78.67/ share.  The total 87,000 shares repurchased in 9M 2020 were at an average price of $80.19/ share.  In May 2019, UTMD repurchased 5,000 shares at $79.52/ share. No other shares were repurchased in 2019. 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.  AnnualizedAfter payment of cash dividends to stockholders, annualized ROE in 9M 20172020 was 14%6% compared to 12%annualized ROE of 11% in 9M 2016.  Annualized ROE (before stockholder dividends) in 9M 2017 was 20% compared to 18% in 9M 2016.  The higher2019. Before the payment of dividends, annualized ROE in 9M 20172020 was 10% compared to 15% in 9M 2019. The lower ROE before dividends in 9M 2020 was due to thean 8% increase in NI.average accumulated stockholders’ equity together with a 29% decrease in 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.

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UTMD’s closing share price at the end of 3Q 2020 was $79.87, down 26% from the $107.90 closing price at the end of 2019.  The closing share price at the end of 3Q 2019 was $95.84.

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 $12,323$14,359 in 9M 20172020 compared to $11,143$11,415 in 9M 2016.2019.  The most$2,944 higher cash provided by operating activities in 9M 2020 was due primarily to a $6,187 difference from 1) 1,184 decreased trade accounts receivable and inventories compared to a $2,588 increase in 9M 2019, yielding a significant differences$3,772 working capital change difference in the two periods, were the $1,616 increase in net income,2) a $831 use of cash from a larger increase in 9M 2017 trade accounts receivable compared to 9M 2016, and a $575 benefit to cash from an larger$651 increase in accrued expenses compared to a $1,023 decrease in 9M 2017 compared to 9M 2016.


2019, yielding another $1,674 working capital change difference in the two periods, 3) $363 higher intangible asset amortization expense, and 4) $378 lower decrease in deferred income taxes, minus 1) $2,983 lower net income and 2) $251 higher decrease in accounts payable.  

Capital expenditures for property and equipment (PP&E) were $174$806 in 9M 20172020 compared to $237$251 in 9M 2016. Capital2019.  The higher capital expenditures of approximately $1.5 millionwere due to a new roof on the Midvale facility and investment in new manufacturing capabilities in Ireland.  There were no capital expenditures for intangible assets in 9M 2020 compared to $21,000 in 9M 2019 for the fit-outpurchase of the UK facility will occur in 4Q 2017.  Depreciationremaining life of PP&E was $489 in 9M 2017 compared to $452 in 9M 2016.


CSI’s exclusive U.S.distribution rights for the Filshie Clip System.

UTMD made cash dividend payments of $1,969$3,097 in 9M 20172020 compared to $1,954$3,083 in 9M 2016.2019.  The Company did not useused $6,976 of its cash to repurchase any87,000 of its own shares in 9M 2020 compared to using $398 of its cash to repurchase 5,000 of its own shares during either 9M 2017 or 9M 2016.


2019.

In 9M 2017,2020, UTMD received $224$282 and issued 6,1985,614 shares of its stock upon the exercise of employee and director stock options, net of 211 shares retired upon employees trading those shares in payment of the stock option exercise price.options. Option exercises in 9M 20172020 were at an average price of $37.39$50.15 per share.  In comparison, in 9M 20162019 the Company received $306$222 and issued 10,0625,629 shares of stock on the exercise of employee and director stock options, net of 861 shares retired upon optionees trading those shares in payment of the stock option exercise price.options. Option exercises in 9M 20162019 were at an average price of $33.12$39.53 per share.


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, for example, to fit-out a UK facility and property purchased in late 2016 specific to UTMD's needs;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.



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k)Assets and Liabilities


September 30, 20172020 total consolidated assets were $90,675, an increase$107,072, a net decrease of $14,091$2,715 from December 31, 2016. The increase2019.   Net intangible assets declined by $5,397, inventories declined by $609 and receivables declined by $466.  Offsetting that combined $6,472 asset decline was due mainly to a $11,156$3,507 increase in cash and investments. Other significant changes in assets included a $1,519$308 increase in consolidatedPP&E net trade receivables,of $495 in depreciation.  As a $500result of the increase in cash, consolidated inventories, and a $496 increase in net intangible assets. UTMD'scurrent assets increased $2,375.

UTMD’s Ireland subsidiary EUR-denominated assets and liabilities on September 30, 2020 were translated into USD at an FX rate 11.9%4.4% higher (stronger EUR)EUR relative to the USD) than the FX rate at the end of 2016. UTMD's2019. UTMD’s UK subsidiary GBP-denominated assets were translated into USD at an FX rate 8.6% higher (stronger2.6% lower (weaker GBP) than the FX rate at the end of 2016.  UTMD's2019.  UTMD’s Australia subsidiary AUD-denominated assets were translated into USD at an FX rate 8.4%1.9% higher (stronger AUD) than the FX rate at the end of 2016.2019.  UTMD’s Canada subsidiary CAD-denominated assets were translated into USD at an FX rate 2.7% lower (weaker CAD) than the FX rate at the end of 2019.  The net book value of consolidated property, plant and equipment increased $441$308 at September 30, 20172020 from the end of 20162019 due to period-ending changed FX rates, $174$806 in new asset purchases and $489$495 in depreciation.


Working capital (current assets minus current liabilities) was $42,838$53,632 at September 30, 2017,2020 compared to $31,845$51,438 at December 31, 2016.  A current asset increase of $13,153 was led by the $11,156 increase in2019. Consolidated receivables and inventories declined $466 and $609, respectively, but cash and investments. Currentincreased $3,507.  Accrued liabilities increased $2,161, including a $1,941 increase in accrued liabilities. The accrued liabilities increase was mainly due to the $986 3Q 2017 quarterly dividend payment to stockholders accrued but not paid until October 3, whereas the $984 4Q 2016 dividend was paid before$649, primarily from $550 higher income taxes payable as UTMD had over-accrued income taxes payable by $514 at the end of December 2016.2019, and $244 higher customer deposits as a result of the timing of international distributor shipments in 4Q 2020 requiring prepayment.  UTMD management believes that its working capital remains sufficient to meet normal operating needs, new capital expenditures and projectedcontinued cash dividend payments to stockholders.


September 30, 20172020 net intangible assets (goodwill plus other intangible assets) increased $496assets less amortization) declined $5,397 from the end of 2016.  The increase was due to the higher FX rate for GBP Femcare intangibles as of September 30, 2017, compared to year-end 2016, offset somewhat by the $1,5262019.  No new intangible assets were acquired in 9M 2017 amortization of Femcare IIA.2020.  At September 30, 2017,2020, net intangible assets including goodwill declined towere 36% of total consolidated assets compared to 41%40% at both year-end 20162019, and 42% at September 30, 2016.

12


2019.

The long term deferred tax liability (DTL) balance for Femcare IIA ($9,084 on the date of the acquisition), was $3,176$2,132 (£1,650) at September 30, 2017,2020, compared to $3,209$2,239 (£1,688) at December 31, 2016,2019, and $3,612$2,170 (£1,764) at September 30, 2016.2019.  Reduction of the deferred tax liabilityDTL occurs as the book/tax difference of IIA amortization is eliminated over the remaining useful life of the Femcare IIA. UTMD'sIIA (because the amortization expense is not tax deductible in the UK). The DTL only declined $107 at September 30, 2020 from December 31, 2019, despite 9M 2020 amortization expense of $1,523, which reduced the DTL balance by $289.  The difference was due to a 2Q 2020 UK tax law change which increased the DTL balance by $225 (£182) plus the change in ending FX rates. The UK decided to not reduce its corporate income tax rate from 19% to 17% beginning in 2Q 2020, as previously enacted. (The $225 increase in deferred UK taxes over the following six years was also booked in the 2Q 2020 tax provision, reducing 9M 2020 net income $225.)

UTMD’s total debt ratio (total liabilities/ total assets) as of September 30, 2017 and December 31, 20162020 was 10%.  UTMD's8%, including a remaining $2,074 REPAT tax liability payable over another five years.  The total debt ratio as of December 31, 2019 was also 8%, and as of September 30, 20162019 was 12%9%.


The $2,715 decrease in total liabilities and equity (same as total assets) was primarily due to a $2,677 September 30, 2020 ending decrease in stockholders’ equity compared to December 31, 2019. Stockholders’ equity was reduced during 9M 2020 by $10,074 from share repurchases and dividends paid to stockholders, offset by $7,386 net profit accumulated during 9M 2020.

l)Management's Outlook


As outlined in its December 31, 20162019 SEC 10-K report, UTMD'sUTMD’s general plan for 2017 is2020 was to

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

Generally,

1)  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; 

4)  continue to achieve excellent overall financial operating performance;  

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

6)  be vigilant for accretive acquisition opportunities which may be brought about by difficult burdens on small, innovative companies.

Although not on its plan relative to specific financial numbers due to the COVID-19 pandemic, the Company continues to effectively execute its general plan as outlined above. Based on results


17


Table of 9M 2017, management expects to exceed the financial objectives for the full year of 2017 as stated in the Form SEC 10-K at the beginning of the year.


Contents


m)Accounting Policy Changes


Accounting Standards Update No. 2016-09, Improvements to Employee Share-Based Payment Accounting, was adopted by the Company effective January 1, 2017, as required by the ASU. This update to ASC 718, Compensation - Stock Compensation was issued by the Financial Accounting Standards Board as part of their simplification initiative.  This adoption had an immaterial impact on UTMD's retained earnings and other components of equity as of the date of adoption. In the statement of cash flows, the effect of the required change related to excess tax benefits, which was immaterial, was retrospectively applied. Stock compensation expense continues to reflect estimated forfeitures.

None

Forward-Looking Information.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 .8465, .9474.8529, .8907 and .8897.9169 EUR per USD as of September 30, 2017,2020, December 31, 20162019 and September 30, 2016,2019, respectively.  Exchange rates were .7463, .8105.7741, .7537 and .7685.8129 GBP per USD as of September 30, 2017,2020, December 31, 20162019 and September 30, 2016,2019, respectively.  Exchange rates were 1.2756, 1.38291.3964, 1.4226 and 1.30441.4823 AUD per USD on September 30, 2017,2020, December 31, 2016,2019, and September 30, 2016,2019, respectively.  Exchange rates were 1.25131.3323, 1.2962, and 1.3242 CAD per USD on September 30, 2017.2020, December 31, 2019, and September 30, 2019, 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.

13

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, 2017.2020. Based on this evaluation, the Chief Executive Officer and Principal Financial Officer concluded that, as of September 30, 2017,2020, 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, 2017,2020, that have materially affected, or are reasonably likely to materially affect, the Company'sCompany’s internal controls over financial reporting.

14


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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.


litigation.

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, 2016,2019, 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 or executive order healthcare reform in the United States, particularly as embodiedsuggested by leading candidates in The Patient Protection and Affordable Care Act anda presidential election year, have the Health Care and Education Reconciliation Act of 2010 (the "Acts") added a substantial excise tax (MDET)  in 2013-2015 that  increased administrative costs and has ledpotential to decreased revenues in the U.S.:

The voluminous Acts, administrative rules to enforce the Acts and promised efforts to reform the Acts, makerender the U.S. medical device marketplace unpredictable, particularlyunpredictable. A fully government-run healthcare system would likely eliminate healthcare consumer choice as well as commercial incentives for innovation.  Government-mandated shutdowns of “nonessential” medical procedures with the thousandsintent of small medical device manufacturers including UTMD that do notprotecting the public from a virus have the overhead structure that the largerpotential to substantially reduce demand for UTMD’s medical device companies can afford.  Fortunately, the U.S. Congress has suspended the MDET for two years of 2016 and 2017.  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's ability to effectively compete and support continued investments in new product development and marketing of specialty devices in the U.S.

devices.    

Increasing regulatory burdens, including premarketing approval delays, may result in significant loss of revenue, unpredictable costs and loss of management focus on helpingdeveloping and marketing products that improve the Company proactively conformquality of healthcare:

Thousands of small focused medical device manufacturers including UTMD that do not have the overhead structure that the few large medical device companies can afford are increasingly burdened with requirementsbureaucratic and thrive:

The Company's experienceunderqualified regulator demands that are not reasonably related to assuring the safety or effectiveness of the devices that they provide.  Premarketing submission administrative burdens, and substantial “user fees” or notified body review fees, represent a significant non-clinical and/or non-scientific barrier to new product introduction, resulting in 2001-2005, when the FDA improperly soughtlack of investment or delays to shut it down, highlights the ongoing risk of being subject to a regulatory environment which can be arbitrary and capricious.revenues from new or improved devices.  The risks associated with such a circumstancecircumstances relate not only to the substantial out-of-pocket costs, ofincluding potential litigation in millions of dollars, but also loss of business theand a diversion of attention of key employees for an extended period of time includingfrom managing their normal responsibilities, particularly in 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's version of the law.  assurance activities.    

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" 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 growthdominance 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, theirTheir business model based on "kickbacks"“kickbacks” would be a violation of law.law in any other industry. 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 todriven by collection of their administrative fees.

15

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.


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.



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A product liability lawsuit could result in significant legal expenses and a large award against the Company:

UTMD's

UTMD’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 sufferssuffered 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's

UTMD’s distributors have varying expertise in marketing and sellingdistributing 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 productsdevices and/or U.S. made raw materials and components are likely being purchased in fixed USD.


Future increases in sales of the Filshie Clip System due to Bayer stopping sales of the Essure device are uncertain, and may not materialize.

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


During 9M 2020, UTMD did not purchase anypurchased 87,000 of its own securities duringshares in the open market for $6,977 including commissions and fees. During 9M 2017.

16

2019 UTMD purchased 5,000 of its shares in the open market for $398 including commissions and fees.

Item 6.  Exhibits


Exhibit #
SEC Reference #
Title of Document
   
131Certification of CEO pursuant to Rule 13a-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
   
231Certification of Principal Financial Officer pursuant to Rule 13a-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
   
332Certification of CEO pursuant to 18 U.S.C. §1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
   
432Certification of Principal Financial Officer pursuant to 18 U.S.C. §1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
   
5101 insXBRL Instance
   
6101.schXBRL Schema
   
7101.calXBRL Calculation
   
8101.defXBRL Definition
   
9101.labXBRL Label
   
10101.preXBRL Presentation


Exhibit #

Title of Document

31.1

Certification of CEO pursuant to Rule 13a-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

31.2

Certification of Principal Financial Officer pursuant to Rule 13a-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

32.1

Certification of CEO pursuant to 18 U.S.C. §1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

32.2

Certification of Principal Financial Officer pursuant to 18 U.S.C. §1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

101

The following financial information from the Utah Medical Products, Inc. quarterly report on Form 10-Q for the quarter ended September 30, 2020, formatted in Inline Extensible Business Reporting Language (iXBRL):  (i) Consolidated Condensed Balance Sheets, (ii) Consolidated Condensed Statements of Income, (iii) Consolidated Condensed Statements of Cash Flows, (iv) Consolidated Statements of Stockholders’ Equity, and (v) related Notes to the Consolidated Condensed Financial Statements, tagged in detail.

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)


20


Table of Contents


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:        11/6/20                             By:       /s/ Kevin L. Cornwell                         

Kevin L. Cornwell 

CEO 

Date:        11/6/20                              By:       /s/ Brian L. Koopman                           

Brian L. Koopman 

Principal Financial Officer 


21


UTAH MEDICAL PRODUCTS, INC.
REGISTRANT
Date: 11/7/17
By: /s/ Kevin L. Cornwell
Kevin L. Cornwell
CEO
Date: 11/7/17
By: /s/ Paul O. Richins
Paul O. Richins
17