UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549


FORM 10-Q

(Mark One)


[X]  QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934


For the Quarterly Period Ended June 30, 20172018


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 Number:0-12305


REPRO MED SYSTEMS, INC.

(Exact name of registrant as specified in its charter)

 

New York

13-3044880

(State or Other Jurisdiction of Incorporation or Organization)

(I.R.S. Employer Identification No.)

 

 

24 Carpenter Road, Chester, New York

10918

(Address of Principal Executive Offices)

(Zip Code)


(845) 469-2042

(Registrant’s telephone number, including area code)


February 28

(Former name, former address and former fiscal year, if changed since last report)


Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 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 (2) has been subject to such filing requirements for the past 90 days.  [X] 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 [X]  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 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 [X]

 

(Do not check if a 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  [X] No


As of August 4, 2017, 37,834,8716, 2018, 38,195,214 shares of common stock, $0.01 par value per share, were outstanding, which excludes 2,737,231 shares of treasury stock.




REPRO MED SYSTEMS, INC.

TABLE OF CONTENTS


 

 

PAGE

 

 

 

PART I FINANCIAL INFORMATION

 

 

 

ITEM 1.

Financial Statements

 

 

 

 

 

Balance Sheets as of June 30, 20172018 (Unaudited) and February 28,December 31, 2017

3

 

 

 

 

Statements of Operations (Unaudited) for the one month ended March 31, 2017 and 2016, and the three and foursix months ended June 30, 20172018 and 2016.2017

4

 

 

 

 

Statements of Cash Flows (Unaudited) for the foursix months ended June 30, 2017,2018 and 20162017

5

 

 

 

 

Notes to Financial Statements

6-116

 

 

 

ITEM 2.

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

12-1712

 

 

 

ITEM 3.

Quantitative and Qualitative Disclosures About Market Risk

1716

 

 

 

ITEM 4.

Controls and Procedures

17

 

 

 

PART II OTHER INFORMATION

 

 

 

ITEM 2.

Unregistered Sales of Equity Securities and Use of Proceeds

17-1817

 

 

 

ITEM 6.

Exhibits

1817


- 2 -



PART I – FINANCIAL INFORMATION


Item 1.  Financial Statements


REPRO MED SYSTEMS, INC.

BALANCE SHEETS


 

June 30,

 

 

 

 

June 30,

 

December 31,

 

 

2017

 

February 28,

 

 

2018

 

2017

 

 

(Unaudited)

 

2017

 

 

(Unaudited)

 

 

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CURRENT ASSETS

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

2,982,508

 

$

3,313,265

 

 

$

3,421,186

 

$

3,974,536

 

Certificate of deposit (restricted cash)

 

1,504,818

 

 

 

Certificates of deposit

 

262,315

 

 

262,314

 

 

159,462

 

 

263,269

 

Accounts receivable less allowance for doubtful accounts of $13,046 at June 30, 2017 and $18,046 at February 28, 2017

 

1,899,622

 

 

1,502,030

 

Accounts receivable less allowance for doubtful accounts of $77,067 at June 30, 2018 and $77,067 at December 31, 2017

 

1,840,094

 

 

1,861,949

 

Inventory

 

1,267,214

 

 

1,353,703

 

 

1,718,294

 

 

1,658,681

 

Tax Receivable

 

 

 

172,457

 

Prepaid expenses

 

 

229,667

 

 

175,955

 

 

 

255,888

 

 

170,739

 

TOTAL CURRENT ASSETS

 

6,641,326

 

 

6,779,724

 

 

8,899,742

 

 

7,929,174

 

Property and equipment, net

 

901,464

 

 

932,092

 

 

795,484

 

 

836,283

 

Patents, net of accumulated amortization of $188,735and $180,137 at June 30, 2017 and February 28, 2017, respectively

 

429,974

 

 

426,943

 

Patents, net of accumulated amortization of $220,340and $203,768 at June 30, 2018 and December 31, 2017, respectively

 

531,685

 

 

483,821

 

Other assets

 

 

31,582

 

 

31,490

 

 

 

31,582

 

 

31,582

 

TOTAL ASSETS

 

$

8,004,346

 

$

8,170,249

 

 

$

10,258,493

 

$

9,280,860

 

 

 

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CURRENT LIABILITIES

 

 

 

 

 

 

 

 

 

 

 

 

Deferred capital gain - current

 

$

22,481

 

$

22,481

 

 

$

15,003

 

$

22,481

 

Accounts payable

 

279,130

 

 

772,428

 

 

711,947

 

 

454,398

 

Accrued expenses

 

353,997

 

 

417,357

 

 

539,473

 

 

658,060

 

Accrued payroll and related taxes

 

212,083

 

 

177,018

 

 

187,307

 

 

334,903

 

Accrued tax liability

 

1,384

 

 

 

 

91,488

 

 

115,854

 

TOTAL CURRENT LIABILITIES

 

 

869,075

 

 

1,389,284

 

 

 

1,545,218

 

 

1,585,696

 

Deferred capital gain – long term

 

15,002

 

 

22,496

 

 

 

 

3,762

 

Deferred tax liability

 

 

95,133

 

 

82,422

 

 

 

20,733

 

 

21,675

 

TOTAL LIABILITIES

 

$

979,210

 

$

1,494,202

 

 

 

1,565,951

 

 

1,611,133

 

 

 

 

 

 

 

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

 

Common stock, $0.01 par value; 75,000,000 shares authorized, 40,572,102 and 40,558,429 shares issued, 37,834,871 and 37,821,198 shares outstanding at June 30, 2017 and February 28, 2017, respectively

 

405,721

 

 

405,584

 

Common stock, $0.01 par value; 75,000,000 shares authorized, 40,907,991 and 40,731,529 shares issued, 38,170,760 and 37,994,298 shares outstanding at June 30, 2018 and December 31, 2017, respectively

 

409,080

 

 

407,315

 

Additional paid-in capital

 

4,117,845

 

 

4,129,726

 

 

4,358,618

 

 

4,216,718

 

Retained earnings

 

 

2,845,774

 

 

2,484,941

 

 

 

4,269,048

 

 

3,389,898

 

 

7,369,340

 

 

7,020,251

 

 

9,036,746

 

 

8,013,931

 

Less: Treasury stock, 2,737,231 shares at June 30, 2017 and February 28, 2017

 

 

(344,204

)

 

(344,204

)

Less: Treasury stock, 2,737,231 shares at June 30, 2018 and December 31, 2017

 

 

(344,204

)

 

(344,204

)

TOTAL STOCKHOLDERS’ EQUITY

 

 

7,025,136

 

 

6,676,047

 

 

 

8,692,542

 

 

7,669,727

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

8,004,346

 

$

8,170,249

 

 

$

10,258,493

 

$

9,280,860

 


The accompanying notes are an integral part of these financial statements


- 3 -



REPRO MED SYSTEMS, INC.

STATEMENTS OF OPERATIONS (UNAUDITED)


 

For the

One Month Ended

 

For the

Three Months Ended

 

For the

Four Months Ended

 

 

For the

Three Months Ended

 

For the

Six Months Ended

 

 

March 31

 

June 30

 

June 30

 

 

June 30,

 

June 30,

 

 

2017

 

2016

 

2017

 

2016

 

2017

 

2016

 

 

2018

 

2017

 

2018

 

2017

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NET SALES

 

$

1,509,619

 

$

1,276,299

 

$

3,829,457

 

$

2,795,894

 

$

5,339,076

 

$

4,072,193

 

 

$

4,502,326

 

$

3,829,457

 

$

8,535,550

 

$

7,467,893

 

Cost of goods sold

 

 

536,823

 

 

446,618

 

 

1,532,158

 

 

1,008,749

 

 

2,068,981

 

 

1,455,367

 

 

 

1,762,742

 

 

1,532,158

 

 

3,330,142

 

 

3,068,639

 

Gross Profit

 

 

972,796

 

 

829,681

 

 

2,297,299

 

 

1,787,145

 

 

3,270,095

 

 

2,616,826

 

 

 

2,739,584

 

 

2,297,299

 

 

5,205,408

 

 

4,399,254

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

OPERATING EXPENSES

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative

 

 

637,707

 

 

655,043

 

 

2,005,336

 

 

2,118,159

 

 

2,643,043

 

 

2,773,202

 

 

 

2,022,631

 

 

2,005,336

 

 

3,902,900

 

 

3,780,445

 

Research and development

 

 

7,872

 

 

14,535

 

 

24,840

 

 

57,403

 

 

32,712

 

 

71,938

 

 

 

23,963

 

 

24,840

 

 

33,811

 

 

70,746

 

Depreciation and amortization

 

 

25,576

 

 

23,536

 

 

76,781

 

 

73,041

 

 

102,357

 

 

96,577

 

 

 

75,978

 

 

76,781

 

 

150,556

 

 

151,662

 

Total Operating Expenses

 

 

671,155

 

 

693,114

 

 

2,106,957

 

 

2,248,603

 

 

2,778,112

 

 

2,941,717

 

 

 

2,122,572

 

 

2,106,957

 

 

4,087,267

 

 

4,002,853

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Operating Profit/(Loss)

 

 

301,641

 

 

136,567

 

 

190,342

 

 

(461,458

)

 

491,983

 

 

(324,891

)

Net Operating Profit

 

 

617,012

 

 

190,342

 

 

1,118,141

 

 

396,401

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-Operating Income/(Expense)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gain/(Loss) on currency exchange

 

 

19,988

 

 

36,673

 

 

34,671

 

 

(24,340

)

 

54,659

 

 

12,333

 

Non-Operating (Expense)/Income

 

 

 

 

 

 

 

 

 

 

 

 

 

(Loss)/Gain on currency exchange

 

 

(19,838

)

 

34,670

 

 

(10,414

)

 

51,744

 

Interest and other income

 

 

322

 

 

321

 

 

421

 

 

752

 

 

743

 

 

1,073

 

 

 

5,501

 

 

421

 

 

6,116

 

 

2,066

 

TOTAL OTHER INCOME/(EXPENSE)

 

 

20,310

 

 

36,994

 

 

35,092

 

 

(23,588

)

 

55,402

 

 

13,406

 

TOTAL OTHER (EXPENSE)/INCOME

 

 

(14,337

)

 

35,091

 

 

(4,298

)

 

53,810

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PROFIT/(LOSS) BEFORE TAXES

 

 

321,951

 

 

173,561

 

 

225,434

 

 

(485,046

)

 

547,385

 

 

(311,485

)

PROFIT BEFORE TAXES

 

 

602,675

 

 

225,433

 

 

1,113,843

 

 

450,211

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income Tax (Expense)Benefit

 

 

(109,590

)

 

(59,231

)

 

(76,962

)

 

164,834

 

 

(186,552

)

 

105,603

 

Income Tax Expense

 

 

(126,952

)

 

(76,961

)

 

(234,693

)

 

(174,788

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NET INCOME/(LOSS)

 

$

212,361

 

$

114,330

 

$

148,472

 

$

(320,212

)

$

360,833

 

$

(205,882

)

NET INCOME

 

$

475,723

 

$

148,472

 

$

879,150

 

$

275,423

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NET INCOME/(LOSS) PER SHARE

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NET INCOME PER SHARE

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

0.01

 

$

 

$

 

$

(0.01

)

$

0.01

 

$

(0.01

)

 

$

0.01

 

$

 

$

0.02

 

$

0.01

 

Diluted

 

$

0.01

 

$

 

$

 

$

(0.01

)

$

0.01

 

$

(0.01

)

 

$

0.01

 

$

 

$

0.02

 

$

0.01

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

37,821,198

 

 

37,966,501

 

 

37,825,209

 

 

37,964,985

 

 

37,824,189

 

 

37,965,370

 

 

 

38,100,040

 

 

37,825,209

 

 

38,058,500

 

 

37,799,981

 

Diluted

 

 

37,847,628

 

 

37,966,501

 

 

37,891,306

 

 

37,964,985

 

 

37,877,694

 

 

37,965,370

 

 

 

38,872,998

 

 

37,899,619

 

 

38,815,301

 

 

37,866,730

 


The accompanying notes are an integral part of these financial statements


- 4 -



REPRO MED SYSTEMS, INC.

STATEMENTS OF CASH FLOWS

(UNAUDITED)


 

For the Four Months Ended

 

 

For the Six Months Ended

 

 

June 30,

 

 

June 30,

 

 

2017

 

2016

 

 

2018

 

2017

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CASH FLOWS FROM OPERATING ACTIVITIES

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Income (Loss)

 

$

360,833

 

$

(205,882

)

Adjustments to reconcile net income (loss) to net cash used in operating activities:

 

 

 

 

 

 

Net Income

 

$

879,150

 

$

275,423

 

Adjustments to reconcile net income to net cash provided by/(used in) operating activities:

 

 

 

 

 

 

 

Amortization of deferred compensation cost

 

 

 

7,000

 

 

 

 

 

7,000

 

Stock based compensation expense

 

7,615

 

 

69,714

 

 

 

94,170

 

 

41,479

 

Depreciation and amortization

 

102,357

 

 

96,577

 

 

 

150,556

 

 

151,662

 

Deferred capital gain - building lease

 

(7,493

)

 

(7,493

)

 

 

(11,240

)

 

(11,240

)

Deferred taxes

 

12,711

 

 

(15,144

)

 

 

(941

)

 

12,937

 

Provision for returns and doubtful accounts

 

(5,000

)

 

(10,312

)

 

 

 

 

(5,603

)

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

Increase in accounts receivable

 

(392,592

)

 

(376,551

)

Decrease in inventory

 

86,489

 

 

1,575

 

Decrease/(Increase) in prepaid expense and other assets

 

118,652

 

 

(108,855

)

(Decrease)/Increase in accounts payable

 

(493,297

)

 

186,109

 

Increase/(Decrease) in accrued payroll and related taxes

 

35,065

 

 

(21,489

)

Decrease/(Increase) in accounts receivable

 

 

21,855

 

 

(597,699

)

(Increase)/Decrease in inventory

 

 

(59,613

)

 

94,177

 

(Increase)/Decrease in prepaid expense and other assets

 

 

(85,149

)

 

33,174

 

Increase/(Decrease) in accounts payable

 

 

257,549

 

 

(492,919

)

(Decrease)/Increase in accrued payroll and related taxes

 

 

(147,597

)

 

71,113

 

Decrease in accrued expense

 

(63,360

)

 

(67,383

)

 

 

(118,587

)

 

(12,207

)

Increase/(Decrease) in accrued tax liability

 

1,384

 

 

(92,003

)

NET CASH USED IN OPERATING ACTIVITIES

 

 

(236,636

)

 

(544,137

)

(Decrease)/Increase in accrued tax liability

 

 

(24,366

)

 

161,851

 

NET CASH PROVIDED BY/(USED IN) OPERATING ACTIVITIES

 

 

955,787

 

 

(270,852

)

 

 

 

 

 

 

 

 

 

 

 

 

 

CASH FLOWS FROM INVESTING ACTIVITIES

 

 

 

 

 

 

 

 

 

 

 

 

 

Payments for property and equipment

 

(63,133

)

 

(74,549

)

Payments for capital expenditures

 

 

(93,185

)

 

(89,437

)

Purchase of certificate of deposit (restricted cash)

 

 

(1,500,000

)

 

 

Reinvested earnings on certificate of deposit (restricted cash)

 

 

(4,818

)

 

 

Payments for patents

 

(11,628

)

 

(29,085

)

 

 

(64,436

)

 

(53,346

)

Proceeds/(reinvested earnings) from certificates of deposit

 

 

103,807

 

 

(1,196

)

NET CASH USED IN INVESTING ACTIVITIES

 

 

(74,761

)

 

(103,634

)

 

 

(1,558,632

)

 

(143,979

)

 

 

 

 

 

 

 

 

 

 

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock issuances

 

 

51,250

 

 

 

Payment for cancelled shares

 

(19,360

)

 

 

 

 

(1,755

)

 

(19,360

)

Purchase of treasury stock

 

 

 

(1,105

)

 

 

 

 

(484

)

NET CASH USED IN FINANCING ACTIVITIES

 

 

(19,360

)

 

(1,105

)

NET CASH PROVIDED BY/(USED) IN FINANCING ACTIVITIES

 

 

49,495

 

 

(19,844

)

 

 

 

 

 

 

 

 

 

 

 

 

 

NET DECREASE IN CASH AND CASH EQUIVALENTS

 

(330,757

)

 

(648,876

)

 

 

(553,350

)

 

(434,675

)

CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD

 

 

3,313,265

 

 

4,201,948

 

 

 

3,974,536

 

 

3,417,183

 

CASH AND CASH EQUIVALENTS, END OF PERIOD

 

$

2,982,508

 

$

3,553,072

 

 

$

3,421,186

 

$

2,982,508

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Supplemental Information

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash paid during the periods for:

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest

 

$

 

$

 

 

$

 

$

 

Taxes

 

$

 

$

90,000

 

 

$

260,000

 

$

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NON-CASH FINANCING AND INVESTING ACTIVITIES

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock as compensation

 

$

45,000

 

$

24,718

 

 

$

67,500

 

$

67,500

 


The accompanying notes are an integral part of these financial statements


- 5 -



REPRO MED SYSTEMS, INC.

NOTES TO THE UNAUDITED FINANCIAL STATEMENTS


NOTE 1  NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES


NATURE OF OPERATIONS


REPRO MED SYSTEMS, INC. (the “Company”, “RMS”, or “we”) designs, manufactures and markets proprietary medical devices primarily for the ambulatory infusion market and emergency medical applications as governed by the United States Food and Drug Administration (the “FDA”) quality and regulatory system and international standards for quality management systems.  The Company operates as one segment.


FISCAL YEAR END


On March 22, 2017, the Board of Directors approved a change in theThe Company’s fiscal year end from February 28 tois December 31. With this fiscal year end change, the Company will report one-time, transitional financial information for the month of March 2017 and the quarter April through June 2017 on Form 10-Q.


BASIS OF PRESENTATION


The accompanying unaudited financial statements as of June 30, 2017,2018, have been prepared in accordance with generally accepted accounting principles and with instructions to SEC regulation S-X for interim financial statements.


In the opinion of the Company’s management, the financial statements contain all adjustments consisting of normal recurring accruals necessary to present fairly the Company’s financial position as of June 30, 2017,2018, and the results of operations and cash flow for the four monthsthree and six month periods ended June 30, 2017,2018, and 2016.2017.


The results of operations for the fourthree and six months ended June 30, 2017,2018, and 20162017 are not necessarily indicative of the results to be expected for the full year.  These interim financial statements should be read in conjunction with the financial statements and notes thereto of the Company and management’s discussion and analysis of financial condition and results of operations included in the Company’s Annual Report for the year ended February 28,December 31, 2017, as filed with the Securities and Exchange Commission on Form 10-K.


USE OF ESTIMATES IN THE FINANCIAL STATEMENTS


The preparation of financial statements in conformity with U.S. generally accepted accounting principles (“U.S. GAAP”) requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. Important estimates include but are not limited to, asset lives, valuation allowances, inventory, and accruals.


RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTSREVENUE RECOGNITION


In May 2017, theThe Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2017-09—Compensation-Stock Compensation (Topic 718),2014-09—Revenue from Contracts with Customers, which provides claritya single comprehensive model for entities to use in accounting for revenue arising from contracts with customers.  We adopted this ASU effective January 1, 2018 on a full retrospective basis.  Adoption of this standard did not result in significant changes to our accounting policies, business processes, systems or controls, or have a material impact on our financial position, results of operations and reduce both (1) diversity in practice and (2) cost and complexity when applying the guidance in Topic 718, Compensation—Stock Compensation, to a change to the termscash flows or conditions of a share-based payment award.  The amendments in this update affect any entity that changes the terms or conditions of a share-based payment award. The amendments in this update are effective for all entities for annual periods, and interim periods within those annual periods, beginning after December 15, 2017.  Early adoption is permitted, including adoption in any interimrelated disclosures.  As such, prior period for (1) public business entities for reporting periods for which financial statements havewere not yet been issuedrecast.


The Company’s revenues result from the sale of assembled products.  We recognize revenues when shipment occurs and (2) all other entities for reporting periods forat which financial statements have not yet been made available for issuance. The amendmentspoint the customer obtains control and ownership of the goods.  Shipping costs generally are billed to customers and are included in this update should be applied prospectively to an award modified on or after the adoption date.  sales.  


The Company generally does not accept return of goods shipped unless it is assessinga Company error.  The only credits provided to customers are for defective merchandise.  The Company warrants the impact ofsyringe driver from defects in materials and workmanship under normal use and the adoption ofwarranty does not include a performance obligation.  The costs under the ASU on its financial statements, disclosure requirements and methods of adoption.warranty are expensed as incurred.


- 6 -



Provisions for distributor pricing and annual customer volume rebates are variable consideration and are recorded as a reduction of revenue in the same period the related sales are recorded or when it’s probable the annual growth target will be achieved.  The rebates are provided to distributors for the difference in selling price to distributor and pricing specified to select customers.


RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS


In June 2016, FASB issued ASU No. 2016-13—Financial Instruments – Credit Losses (Topic 326); Measurement of Credit Losses on Financial Instruments, which amends guidance on reporting credit losses for assets held at amortized cost basis and available for sale debt securities.  For assets held at amortized cost basis, Topic 326 eliminates the probable initial recognition threshold in current GAAP and, instead, requires an entity to reflect its current estimate of all expected credit losses. The allowance for credit losses is a valuation account that is deducted from the amortized cost basis of the financial assets to present the net amount expected to be collected.  For available for sale debt securities, credit losses should be measured in a manner similar to current GAAP, however Topic 326 will require that credit losses be presented as an allowance rather than as a write-down.  This ASU affects entities holding financial assets and net investment in leases that are not accounted for at fair value through net income. The amendments affect loans, debt securities, trade receivables, net investments in leases, off balance sheet credit exposures, reinsurance receivables, and any other financial assets not excluded from the scope that have the contractual right to receive cash.  The amendments in this update are effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years.  The Company is assessing the impact of the adoption of the ASU on its financial statements, disclosure requirements and methods of adoption.


In May 2014, the FASB issued ASU No. 2014-09—Revenue from Contracts with Customers. The ASU clarifies the principles for recognizing revenue and develops a common revenue standard for U.S. GAAP and International Financial Reporting Standards (“IFRS”) that removes inconsistencies and weaknesses in revenue requirements, provides a more robust framework for addressing revenue issues, improves comparability of revenue recognition practices across entities, industries, jurisdictions and capital markets, provides more useful information to users of the financial statements through improved disclosure requirements and simplifies the preparation of financial statements by reducing the number of requirements to which an entity must refer. The amendments in this update are effective for the annual reporting periods beginning after December 15, 2016, including interim periods within that reporting period. Full or modified retrospective adoption is required and early application is not permitted. On July 9, 2015, the FASB issued ASU No. 2015-14 Revenue from Contracts with Customers (Topic 606); Deferral of the Effective Date, which (a) delays the effective date of ASU 2014-09, Revenue from Contracts with Customers (Topic 606), by one year to annual periods beginning after December 15, 2017 and (b) allows early adoption of the ASU by all entities as of the original effective date for public entities.  We currently anticipate adopting the new standard using the modified retrospective method beginning January 1, 2018.  In March 2016, the FASB issued ASU No. 2016-08 Revenue from Contracts with Customers (Topic 606); Principal versus Agent Considerations (Reporting Revenue Gross versus Net), which is intended to improve the operability and understandability of the implementation guidance on principal versus agent considerations and the effective date is the same as the requirements in ASU 2014-09.  In April 2016, the FASB issued ASU No. 2016-10 Revenue from Contracts with Customers (Topic 606); Identifying Performance Obligations and Licensing, which is intended to clarify identifying performance obligations and the licensing implementation guidance, while retaining the related principles for those areas and the effective date is the same as the requirements in ASU 2014-09.  In May 2016, FASB issued ASU No. 2016-12—Revenue from Contracts with Customers (Topic 606); Narrow-Scope Improvements and Practical Expedients, which is intended to not change the core principle of the guidance in Topic 606, but rather affect only the narrow aspects of Topic 606 by reducing the potential for diversity in practice at initial application and by reducing the cost and complexity of applying Topic 606 both at transition and on an ongoing basis.  The effective date and transition requirements for the amendments in this update are the same as the effective date and transition requirements for Topic 606 (and any other Topic amended by update 2014-09).    In December 2016, the FASB issued ASU No. 2016-20 Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers, which represents changes to make minor improvements to the Codification that are not expected to have a significant effect on current accounting practice or create a significant administrative cost to most entities.  This update is the final, combined version of Proposed Accounting Standards Updates 2016-240 and 2016-320 (both entitled Technical Corrections and Improvements), which have been deleted.  Based upon our initial evaluation, we do not expect the adoption of the standard and related amendments to have a material effect on our financial condition or results of operations.


In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842).  The main difference between the current requirement under GAAP and this ASU is the recognition of lease assets and lease liabilities by lessees for those leases classified as operating leases.  This ASU requires that a lessee recognize in the statement of financial position a liability to make lease payments (the lease liability) and a right-of-use asset representing its right to use the underlying asset for the lease term (other than leases that meet the definition of a short-term lease).  The liability will be equal to the present value of lease payments.  The asset will be based on the liability, subject to adjustment, such as for initial direct costs.  For income statement purposes, the FASB retained a dual model, requiring leases to be classified as either operating or finance.  Operating leases will result in straight-line expense (similar to current operating leases) while finance leases will result in a front-loaded expense pattern (similar to current capital leases).  Classification will be based on criteria that are largely similar to those applied in current lease accounting.  For lessors, the guidance modifies the classification criteria and the accounting for sales-type and direct financing leases.  This is effective for annual and interim periods beginning after December 15, 2018 and early adoption is permitted.  This ASU must be adopted using a modified retrospective transition, and provides for certain practical expedients.  Transition will require application of the new guidance at the beginning of the earliest comparative period presented.  We are currently assessing the potential impact of this ASU on our financial statements, disclosure requirements and methods of adoption.


- 7 -



The Company considers the applicability and impact of all recently issued accounting pronouncements.  Recent accounting pronouncements not specifically identified in our disclosures are either not applicable to the Company or are not expected to have a material effect on our financial condition or results of operations.


STOCK-BASED COMPENSATION


The Company maintains a long-term incentive stock benefit plan under which it grants stock options and restricted stock to certain directors and key employees.  The fair value of each option grant is estimated on the date of the grant using the Black-Scholes option-pricing model. All options are charged against income at their fair value.  The entire compensation expense of the award is recognized over the vesting period. Shares of restricted stock granted are recorded at the fair value of the shares at the grant date and are recognized over the vesting period.


RECLASSIFICATION


Certain reclassifications have been made to conform prior period data to the current presentation.  These reclassifications had no effect on reported net income.


- 7 -



NOTE 2  RELATED PARTY TRANSACTIONS


On December 20, 2013, we executed an agreement effective March 1, 2014, with a Company director, Dr. Paul Mark Baker, to provide clinical research and support services related to new and enhanced applications for the FREEDOM60® Syringe InfusionFREEDOM System.  Authorized by the Board of Directors, the agreement providesprovided for payment of 420,000 shares of common stock valued at $0.20 per share over a three-year period.  Amortization amounted towas zero for the three months ended June 30, 2018 and 2017, respectively, and zero and $7,000 for the foursix months ended June 30, 2018 and 2017, and 2016, respectively.


On October 21, 2015, Cyril Narishkin was appointed to the Board of Directors and Interim Chief Operating Officer of the Company. Also effective October 21, 2015, we entered into a consulting agreement with Mr. Narishkin, to support our expanded management team and accelerate our growth opportunities under his role of Interim Chief Operating Officer.  The agreement provided for payment of $16,000 per month for eight days per month, of which half was to be paid in cash and half was to be paid in shares of common stock. Effective January 1, 2016,respectively; the agreement provided for the same payment of $16,000 per month, of which seventy-five percent was to be paid in cash and twenty-five percent was to be paid in shares of common stock.is fully amortized.


On June 24, 2016, Cyril Narishkin, the Company’s former Chief Operating Officer, executed a termination and general release agreement, which terminated his previous consulting agreement, and resigned as an officer and director for personal reasons.  Mr. Narishkin was compensated for services as a consultant through January 31, 2017 at a monthly rate of $16,000 per month for up to eight days of service a month upon request of the Company.  Mr. Narishkin’s compensation was zero and $118,000 for the fourthree months ended June 30, 2018 and 2017, respectively, and 2016,was zero and $16,000 for the six months ended June 30, 2018 and 2017, respectively.


In accordance withJanuary 2017, Brad Sealfon, the agreement,son of Andrew Sealfon, a Company Director and former President and Chief Executive Officer, consulted for the Company repurchased 96,542 sharesin its production and quality departments and was compensated $5,184.  In March 2017, Mr. Sealfon provided additional consulting as a principal of common stock ofStokequest, LLC for the Company owned byin its marketing department and was compensated $2,000.   Mr. Narishkin at an aggregate purchase price of $43,393.Sealfon has not performed any consulting for the Company during the six months ended June 30, 2018.


LEASED AIRCRAFT


The Company leases an aircraft from a company controlled by Andrew Sealfon, the Company’sa Company Director and former President and Chief Executive Officer. The lease payments were $5,668 and $7,167$3,876 for the fourboth three months ended June 30, 2018 and 2017, and $7,752 and $9,251 for the six months ended June 30, 2016,2018 and 2017, respectively.  The original lease agreement has expired and the Company is currently on a month-to-month basis for rental payments.


BUILDING LEASE


Mr. Mark Pastreich, a director, is a principal in the entity that owns the building leased by Company. The Company is in year nineteentwenty of a twenty-year lease. There have been no changes to lease terms since his directorship and none are expected through the life of the current lease. With a monthly lease amount of $11,042, the lease payments were $44,168$33,126 for each of the fourthree months ended June 30, 2018 and 2017 and $66,252 for each of the six months ended June 30, 2016.2018 and 2017.  The Company also paid property taxes for the fourthree months ended June 30, 20172018 and June 30, 20162017 in the amount of $16,236$12,720 and $15,825,$12,418, respectively, and $25,432 and $24,585 for the six months ended June 30, 2018 and 2017, respectively.


We are currently seeking another location within  On November 14, 2017, the Company executed a 30 mile radius from our current facilitylease extension, which calls for six month extensions beginning March 1, 2019 with more square footagethe option to accommodate our expanding needs.  In addition to the increased costsrenew six times at monthly lease amount of occupying a larger space, we expect to incur additional costs in connection with construction and FDA compliance with respect to the new location.  There can be no assurance that we will find a suitable location before our current lease expires on terms that are economically favorable to us or at all.$12,088.


- 8 -




NOTE 3 PROPERTY AND EQUIPMENT


Property and equipment consists of the following at:


 

June 30, 2017

 

February 28, 2017

 

 

June 30, 2018

 

December 31, 2017

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Land

 

$

54,030

 

$

54,030

 

 

$

54,030

 

$

54,030

 

Building

 

 

171,094

 

 

171,094

 

 

 

171,094

 

 

171,094

 

Vehicles

 

 

60,784

 

 

43,836

 

Furniture, office equipment, and leasehold improvements

 

 

1,048,818

 

 

1,022,942

 

 

 

1,020,801

 

 

1,008,665

 

Manufacturing equipment and tooling

 

 

1,031,207

 

 

1,003,166

 

 

 

1,129,827

 

 

1,075,471

 

 

 

2,305,149

 

 

2,251,232

 

 

 

2,436,536

 

 

2,353,096

 

Less: accumulated depreciation

 

 

1,403,685

 

 

1,319,140

 

 

 

(1,641,052

)

 

(1,516,813

)

Property and equipment, net

 

$

901,464

 

$

932,092

 

 

$

795,484

 

$

836,283

 


Depreciation expense was $67,504and $70,154 for the three months ended June 30, 2018 and 2017, respectively, and $133,984 and$139,162 for the six months ended June 30, 2018 and 2017, respectively.


- 8 -



NOTE 4  LEGAL PROCEEDINGS


Lawyers representingThe Company is involved in several lawsuits with its competitor, EMED Technologies Corp. (“EMED”) sent RMS a letter dated, May 1, 2013, which, wherein EMED has alleged that the RMS High-Flo Butterfly design infringed a patentCompany’s needle sets infringe various patents controlled by EMED.  RMS disputed this claimCertain of these lawsuits also allege antitrust violations, unfair business practices and we believedvarious other claims.  Although no assurances can be given, the Company believes it likely that our design did not infringeeach of EMED’s patents at issue in these cases will be deemed invalid and that the Company will succeed on the merits with respect to all of the other elements of the cases.


The initial case involving EMED patent itself was not valid.  Under advice of counsel, on September 20, 2013,filed by the Company commenced in the United States District Court for the Eastern District of California on September 20, 2013, in response to a declaratory judgment action against competitor,letter from EMED claiming infringement by RMS, and sought to establish the invalidity of one of EMED’s patents and non-infringement of the Company’s needle sets.patent referenced in the letter – patent US 8,500,703 – or “’703.”  EMED answered the complaint and asserted patent infringement of ’703 and unfair business practice counterclaims. The Company responded by asserting its ownadding unfair business practice claims against EMED.  Both parties have requested injunctive relief and monetary damages. Discoverydamages in unspecified amounts.


On August 22, 2017, the Company filed a motion in this California case seeking a Preliminary Injunction prohibiting EMED from making false statements and claims regarding the products of both companies.  The motion has now been fully briefed, and the parties are awaiting action by the Court.


Earlier, on September 11, 2015, the Company requested an ex parte reexamination of the ’703 patent by the US Patent and Trademark Office (USPTO). The ex parte reexamination resulted in a Final Office Action dated July 19, 2017 rejecting all EMED claims of the patent.  On January 25, 2018 EMED filed an Appeal Brief with a Petition for Revival, and the ex parte reexamination is ongoing.


On June 16, 2015, the Court issued what it termed a “narrow” preliminary injunction against the Company from making certain statements regarding some of EMED’s products. On June 23, 2016,The second court case was filed by EMED filed a motion seeking to have the Company held in contempt, claiming that certain language in the Company’s device labeling does not comply with the injunction. In response to a show cause order, the Company advised the Court that the language in the Company’s labeling that EMED challenged is language that the FDA directed the Company to use in its labeling. The Court discharged the show cause order, effectively rejecting EMED’s contempt argument.


On March 24, 2016, EMED filed a motion seeking a second preliminary injunction prohibiting RMS from selling three of its products in California. The Company opposed that motion on April 19, 2016. A decision on the motion is still pending.


On June 25, 2015, EMED filed a claim of patent infringement for the second of its patents, also directed to the Company’s needle sets, in the United States District Court for the Eastern District of Texas.Texas on June 25, 2015, claiming patent infringement of another of its patents (US 8,961,476 – “’476”), by the Company’s needle sets, and seeking unspecified monetary damages. This second’476 patent is related to the one concerning the Company’s declaratory judgment action. Given the close relationship between the two patents,’703 patent.


On September 17, 2015 the Company requested thatan inter partes review (“IPR”) of ’476, and in response to the Texas suit be transferred to California. Also, based on a validity review of the patent in the U.S. Patent and Trademark Office (“USPTO”), discussed below, the Company requested the Texas suit be stayed. On May 12, 2016,Company’s request, the Court entered an order staying the second case until after the Patent Trial and Appeal Board (“PTAB”) atof the USPTO issuedmade a final written decision regarding the validity of the patent.  On January 12, 2017, the PTAB issued its final written decisionFinal Written Decision in RMS’s favor invalidating all but one of the claims asserted byin this patent.  (The Company believes the remaining claim is not independently material to any of EMED’s litigation claims or RMS’s rights.)  EMED in the Texas litigation. On January 26, 2017, the Company and EMED requested that the Texas case remain stayed pending EMED’s appeal ofappealed the PTAB’s final ruling to the United States Court of Appeals for the Federal Circuit, (“CAFC”).which affirmed the PTAB’s Final Written Decision in the Company’s favor on April 3, 2018.  On April 18, 2018, EMED filed a petition for en banc rehearing.  The second court case in the Eastern District of Texas remains stayed pending EMED’s exhaustion of its rights of judicial review of the PTAB’s decision.


Following the PTAB’s Final Written Decision in the IPR of ’476, EMED filed a new patent application claiming priority back to the application that issued as ’703 at issue in the California case.  Submitted for accelerated examination, this new application issued as US 9,808,576 – “’576” on November 7, 2017.  On this same date, EMED filed a new case (third case) in the United States District Court for the Eastern District of Texas claiming patent infringement of ’576, also directed to the Company’s needle sets, and seeking unspecified damages and a preliminary injunction against the Company’s marketing of its needle sets. RMS has filed a Motion to Dismiss or Transfer Venue to the Southern District of New York, as RMS has no physical or direct presence in the Eastern District of Texas.  RMS also filed an opposition to EMED’s preliminary injunction motion, to which EMED did not file a reply.  The Eastern District of Texas has now ordered the case moved to the Southern District of New York, which has now occurred.


On September 11, 2015, the Company requested an ex parte reexamination of the patent in the first filed case, and on September 17, 2015May 4, 2018 the Company requested an inter partesparties review (“IPR”) of ’576 and EMED’s response is due in mid-August.   Upon the patentsubmission of that Response, the Company intends to Move for Stay of the ’576 Southern District of New York matter.


EMED has petitioned the Eastern District of Texas for right to move the ’476 matter to the Southern District of New York and for leave to amend the original complaint, but neither request is believed likely to succeed as both issues are years past statutory deadlines and at odds with prior statements made by EMED in this matter.


On April 23, 2018, EMED filed a new Civil Case in the second filed case. On November 20, 2015, the USPTO instituted the ex parte reexamination request having found a substantial new questionEastern District of patentability concerning EMED’s patentTexas asserting antitrust, defamation and unfair business practice claims, and seeking unspecified damages, similar to those previously presented in the first case, described above.  The Company has filed case. All EMED claims have been rejecteda Motion to Dismiss and the parties are awaiting a decision by the USPTO Examiner in a Non-Final Office Action. EMED filed a response that is awaiting consideration by the Examiner. Thus, the ex parte reexamination is ongoing. A decision to institute the IPR for EMED’s patent in the second filed case was ordered by the USPTO on February 19, 2016 having determined a reasonable likelihood all claims of the patent may be found to be unpatentable. Oral argument for the IPR was held on November 22, 2016 and a final ruling issued on January 12, 2017. In its final ruling, the PTAB held the claim asserted by EMED against the Company in the second filed case was invalid. EMED appealed the PTAB’s final ruling, and EMED’s opening brief in the CAFC was filed on June 26, 2017.  The Company is now responding.Court.


Although the Company believes it has meritorious claims and defenses in these actions and proceedings, their outcomes cannot be predicted with any certainty. We believe that it is very likely both patents will be determined invalid, however, ifIf any of these actions against the Company are successful, they could have a material adverse effect on the Company’s business, results of operations, financial condition and cash flows.


- 9 -



NOTE 5  STOCKHOLDERS’ EQUITY


On September 30, 2015,June 29, 2016, RMS’s Board of Directors authorized the Company to make open market purchases of up to 2,000,000 shares of the Company’s Outstandingoutstanding Common Stock.  The purchases are made through a broker designated by the Company, with price, timing and volume restrictions based on average daily trading volume, consistent with the rules of the Securities and Exchange Commission for such repurchases.  As of June 30, 2017,2018, the Company had repurchased 396,606 shares at an average price of $0.45 under the program.$0.45. The management of the Company has decided to discontinue repurchasing its outstanding common stock under the program for an undetermined period of time to utilize cash for capital investments needed to expand the business.


NOTE 6  STOCK-BASED COMPENSATION


On September 30, 2015,June 29, 2016, the Board of Directors approvedamended the 2015 Stock Option Plan (“the Plan”) authorizing the Company to grant stock option awards to certain officers, employees and consultants under the Plan, subject to shareholder approvalplan at fair market value, which was approved by shareholders at the Annual Meeting of Shareholders held on September 6, 2016.  The total number of shares of common stock of the Company, par value $0.01 per share (“Common Stock”),Stock, with respect to which awards may be granted pursuant to the Plan, wasshall not to exceed 2,000,000 shares.


On June 29, 2016, the Board of Directors approved the amendment to the Plan authorizing the total number of shares of common stock authorized to be subject to awards granted under the Plan to be increased to 4,000,000 shares.  On September 6, 2016, at the Annual Shareholder Meeting, the Company’s shareholders approved the Plan as amended.


As of June 30, 2017,2018, there were outstanding 1,113,000931,000 options awarded to certain executives, key employees and advisory board members under the Plan.


On October 21, 2015, the Board of Directors of the Company approved non-employee director compensation of $25,000 each annually, to be paid quarterly half in cash and half in common stock, beginning September 1, 2015.


The per share weighted average fair value of stock options granted during the foursix months ended June 30, 20172018 and June 30, 20162017 was $0.24 and zero,$0.75and $0.25, respectively. The fair value of each award is estimated on the grant date using the Black-Scholes option pricing model with the following weighted average assumptions used for grants in the foursix months ended June 30, 20172018 and June 30, 2016.2017. Historical information was the primary basis for the selection of the expected volatility, expected dividend yield and the expected lives of the options.  The risk-free interest rate was selected based upon yields of the U.S. Treasury issues with a term equal to the expected life of the option being valued:


 

June 30,

 

 

June 30,

 

 

2017

 

2016

 

 

2018

 

2017

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Dividend yield

 

 

0.00%

 

 

0.00%

 

 

0.00%

 

 

0.00%

 

Expected Volatility

 

 

59.00-72.2%

 

 

59.00%

 

 

65.2%

 

 

70.9-72.20%

 

Weighted-average volatility

 

 

 

 

 

 

 

 

 

Expected dividends

 

 

 

 

 

 

 

 

 

Expected term (in years)

 

 

4 - 5 Years

 

 

5 Years

 

 

5 Years

 

 

5 Years

 

Risk-free rate

 

 

2.17-2.48%

 

 

2.17%

 

 

2.80%

 

 

2.36-2.48%

 


- 10 -



The following table summarizes the status of the Plan:


 

Four Months Ended June 30,

 

 

Six months Ended June 30,

 

 

2017

 

2016

 

 

2018

 

2017

 

 

Shares

 

Weighted
Average
Exercise
Price

 

Shares

 

Weighted
Average
Exercise
Price

 

 

Shares

 

Weighted
Average
Exercise
Price

 

Shares

 

Weighted
Average
Exercise
Price

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Outstanding at March 1

 

1,345,000

 

$

0.39

 

 

1,060,000

 

$

0.37

 

Outstanding at January 1

 

1,038,000

 

$

0.41

 

 

905,000

 

$

0.37

 

Granted

 

18,000

 

$

 

 

 

$

 

 

18,000

 

$

1.33

 

 

518,000

 

$

0.41

 

Exercised

 

 

$

 

 

 

$

 

 

125,000

 

$

0.41

 

 

 

$

 

Forfeited

 

250,000

 

$

0.36

 

 

 

$

 

 

 

$

 

 

310,000

 

$

0.36

 

Outstanding at June 30

 

1,113,000

 

$

0.39

 

 

1,060,000

 

$

0.37

 

 

931,000

 

$

0.43

 

 

1,113,000

 

$

0.39

 

Options exercisable at June 30,

 

538,000

 

$

0.38

  

 

 

$

 

Weighted average fair value of options granted during the period

 

 

$

 

 

 

$

 

Options exercisable at June 30

 

656,885

 

$

0.39

 

 

538,000

 

$

0.38

 

Stock-based compensation expense

 

 

$

(37,385

)

 

 

$

50,055

 

 

 

$

26,670

 

 

 

$

(26,021

)


- 10 -



Total stock-based compensation expense, net of estimated forfeitures for stock option awards totaled $(37,385)$26,670 and $50,055($26,021) for the foursix months ended June 30, 20172018 and June 30, 2016,2017, respectively. Cash received from option exercises for the six months ended June 30, 2018 and 2017 was $51,250 and zero, respectively.


The weighted-average grant-date fair value of options granted during the foursix months ended June 30, 20172018 and June 30, 2016,2017, was $4,356$0.75 and zero,$0.25, respectively.  The total intrinsic value of options exercised during the foursix months ended June 30, 20172018 and June 30, 2016,2017, was $30,664 and zero, for both periods.respectively.


The following table presents information pertaining to options outstanding at June 30, 2017:2018:


Range of Exercise Price

 

Number
Outstanding

 

Weighted
Average
Remaining
Contractual
Life

 

Weighted
Average
Exercise
Price

 

Number
Exercisable

 

Weighted
Average
Exercise
Price

 

 

Number
Outstanding

 

Weighted
Average
Remaining
Contractual
Life

 

Weighted
Average
Exercise
Price

 

Number
Exercisable

 

Weighted
Average
Exercise
Price

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

$0.36 - $0.41

 

1,113,000

 

5 years

 

$

0.39

 

538,000

 

$

0.38

 

$0.36 - $1.33

 

931,000

 

5 years

 

$

0.43

 

656,885

 

$

0.39

 


As of June 30, 2017,2018, there was $113,821$64,507 of total unrecognized compensation cost related to non-vested share-based compensation arrangements granted under the Plan. That cost is expected to be recognized over a weighted-average period of 1719 months. The total fair value of shares vested during the four months endedas of June 30, 2018 and June 30, 2017, was $135,979 and $107,732, respectively.


NOTE 7  DEBT OBLIGATIONS


On February 8, 2018, the Company executed a Promissory Note with KeyBank National Association in the amount of $1.5 million as a variable rate revolving line of credit loan due on demand with an interest rate of Libor plus 2.25%, collateralized with a certificate of deposit in the amount of $1.5 million.  The Company entered into this arrangement to establish a credit lending history and, in the event needed, to have additional cash on hand for future expansion.  As of June 30, 2016, was $9,300 and zero, respectively.2018 the Company has no outstanding amounts against the line of credit.


- 11 -



PART I – ITEM 2.  MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.


This Quarterly Report on Form 10-Q contains certain “forward-looking” statements (as such term is defined in the Private Securities Litigation Reform Act of 1995) and information relating to us that are based on the beliefs of the management, as well as assumptions made and information currently available.


Our actual results may vary materially from the forward-looking statements made in this report due to important factors such as uncertainties associated with future operating results, unpredictability related to Food and Drug Administration regulations, introduction of competitive products, limited liquidity,acceptance of and demand for new and existing products, ability to penetrate new markets, success in enforcing and obtaining patents, reimbursement related risks, government regulation of the home health care industry, success of the research and development effort, expanding the market of FREEDOM60®,demand in the SCIg market, availability of sufficient capital to continue operations,if or when needed, dependence on key personnel and the outcome of litigation and regulatory investigation.litigation. When used in this report, the words “estimate,” “project,” “believe,” “may,” “will,” “anticipate,” “intend,” “expect” and similar expressions are intended to identify forward-looking statements. Such statements reflect current views with respect to future events based on currently available information and are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated in such forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.  These statements involve risks and uncertainties with respect to the ability to raise capital if or when needed to develop and market new products, acceptance of and demand for new and existing products, ability to penetrate new markets, our success in enforcing and obtaining patents, obtaining required Government approvals, attracting and maintaining key personnel, succeeding in litigation claims and resolving the FDA Warning Letter that could cause the actual results to differ materially. Our actual results, performance and achievements could differ materially from those expressed or implied in these forward-looking statements. The Company does not undertake any obligation to release publicly any revision to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.


Throughout this report, “RMS,” the “Company,” “we,” “us” and “our” refer to Repro Med Systems, Inc.


OVERVIEW


On March 22, 2017, the Board of Directors approved a change in the Company’s fiscal year end from February 28 to December 31. With this fiscal year end change, the Company is reporting one-time, transitional financial informationNet sales increased 17.6% for the month of  March 2017 and the quarter April through June 2017.


During the four month period ended June 30, 2017, we delivered sales growth both domestically and internationally, ramped up production to keep pace with demand and found ways to lower costs.  The FDA renewed our Certificate to Foreign Government which is used to communicate to foreign governments that the FDA certified that RMS meets good manufacturing practices and quality system regulations.  We received registrations in new countries, launched our new flow controller in Europe and started several clinical trials with drug companies.  Furthermore, we have launched a new marketing campaign, redesigned our packaging and entered the social media world to help extend our brand awareness.  We plan to continue to focus on global sales growth, cost control and new product development.  Additionally, we continue to look for a new facility with more square footage to accommodate our expanding needs.


Our net sales results for the fourthree months ended June 30, 2017 increased 31.1%, versus the same period last year.  Part of the increase was the result of backorders of $0.4 million at February 28, 2017 which were filled during the four months ended June 30, 2017.  Excluding these backorders, net sales grew 21.6% driven by organic growth both domestically and internationally, which included two large pump orders accelerated into this period and a large return of product related to a market withdrawal last year.   Our selling, general and administrative costs were 4.7% lower for the four months ended June 30, 20172018, as compared with the same period last year.  We saw a significant reductionThe increase in legal feesnet sales was driven by higher needle set sales, which we believe was bolstered by the FDA clearance for the RMS “Integrated Catch-Up Freedom Syringe Driver Infusion System” on August 31, 2017, which includes both subcutaneous medications, specifically immunoglobulins and intravenous medications, such as antibiotics as well as sales from the recently FDA approved first use of immunoglobulin for chronic inflammatory demyelinating polyneuropathy (“CIDP”) indication for the subcutaneous drug Hizentra®.  Net sales during the period included approximately $0.3 million of revenue related to our litigation and FDA regulatory efforts.  However, we cannot predict whether this trend will continue, nor can we predict the outcome of the litigation or regulatory process.  We also had reductions inone-time sales and marketing driven by reduced recruiting and consulting fees that were incurred last year related to our website redesign, public relations, sales training and lead generation efforts and the timing of spend for current year marketing initiatives.  Offsetting these savings were increased salary and related benefit costs in our regulatory department due to headcount to support our regulatory compliance requirements.the clinical activities for pharmaceutical companies.  Net income for the period increased three-fold to $0.5 million, or 10.6% of net sales, which compares with $0.1 million reported during the second quarter of 2017.  Higher net sales combined with improved gross profits on relatively flat operating expenses and a favorable tax rate change contributed to the increase in profitability.


- 12 -



RESULTS OF OPERATIONS


Four Months EndedThree months ended June 30, 20172018 compared to June 30, 20162017


Net Sales


The following table summarizes our net sales for the fourthree months ended June 30, 20172018 and 2016:2017:


 

Four Months Ended June 30,

 

Change from Prior Year

 

% of Sales

 

 

Three Months Ended June 30,

 

Change from Prior Year

 

% of Sales

 

 

2017

 

2016

 

$

 

%

 

2016

 

2015

 

 

2018

 

2017

 

$

 

%

 

2018

 

2017

 

Sales

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Domestic

 

$

4,254,605

 

$

3,287,740

 

$

966,865

 

29.4%

 

79.7%

 

80.7%

 

 

$

3,582,392

 

$

2,988,833

 

$

593,559

 

19.9%

 

79.6%

 

78.0%

 

International

 

 

1,084,471

 

 

784,453

 

 

300,018

 

38.2%

 

20.3%

 

19.3%

 

 

 

919,934

 

 

840,624

 

 

79,310

 

9.4%

 

20.4%

 

22.0%

 

Total

 

$

5,339,076

 

$

4,072,193

 

$

1,266,883

 

31.1%

 

 

 

 

 

 

$

4,502,326

 

$

3,829,457

 

$

672,869

 

17.6%

 

 

 

 

 


Total net sales increased $1.3$0.7 million or 31.1%17.6% for the four months endedthree monthsended June 30, 20172018 compared with the same period last year. Part of the increase came from fulfilling backorders of $0.4 million at February 28, 2017.  Excluding these backorders, net sales increased 21.6%.  This growth was driven mostly by bothincreased volume in domestic and internationalneedle sales.  We believe our 510(k) clearance described above contributed to the increase, as well as sales resulting from increased organic growth in all product categories.  The launch of a new drug generated increased needle sales as customers built inventory, two large pump orders were accelerated forward into this period and last year included a large return of product related to a market withdrawal.  We continue to concentrateour pharmaceutical partners for clinical trials, which added $0.3 million for the majority of our efforts in our infusion product lines, specifically towards new applications in both domestic and international markets.  We continue to pursue registrations in new countries, although revenue realization could take up to eighteen months from the initial registration efforts.  We also continue to expand our sales efforts into the antibiotic market.three months.


- 12 -



Gross Profit


Our gross profit for the fourthree months ended June 30, 20172018 and 20162017 is as follows:


 

Four Months Ended June 30,

 

Change from Prior Year

 

 

Three Months Ended June 30,

 

Change from Prior Year

 

 

2017

 

2016

 

$

 

%

 

 

2018

 

2017

 

$

 

%

 

Gross Profit

 

$

3,270,095

 

$

2,616,826

 

$

653,269

 

25.0%

 

 

$

2,739,584

 

$

2,297,299

 

$

442,285

 

19.3%

 

Stated as a Percentage of Net Sales

 

 

61.2%

 

 

64.3%

 

 

 

 

 

 

 

 

60.8%

 

 

60.0%

 

 

 

 

 

 


Gross profit increased $0.7$0.4 million or 25.0%19.3% in the fourthree months ended June 30, 2017,2018, compared to the same period in 2016.  This2017.This increase in the quarter was mostly driven by the increase in net revenues of $1.3 million.  Partially offsetting this increase was higher production costs related to scrap during quality inspections as we work to implement a nondestructive testing protocol.  Additionally, we had higher sterilization costs due to more frequent cycles required to meet demand and backlog and increased shipping costs due to the backlog.  We also had higher production salary and related benefits costs from overtime and the addition of a second shift to meet increased demand.sales.


Selling, general and administrative and Research and development


Our selling, general and administrative expenses and research and development costs for the fourthree months ended June 30, 20172018 and 20162017 are as follows:


 

Four Months Ended June 30,

 

Change from Prior Year

 

 

Three Months Ended June 30,

 

Change from Prior Year

 

 

2017

 

2016

 

$

 

%

 

 

2018

 

2017

 

$

 

%

 

Selling, general and administrative

 

$

2,643,043

 

$

2,773,202

 

 

(130,159

)

(4.7%

)

 

$

2,022,631

 

 

2,005,336

 

$

17,295

 

0.9%

 

Research and development

 

 

32,712

 

 

71,938

 

 

(39,226

)

(54.5%

)

 

 

23,963

 

 

24,840

 

 

(877

)

(3.5%

)

 

$

2,675,755

 

$

2,845,140

 

 

(169,385

)

(-6.0%

)

 

$

2,046,594

 

 

2,030,176

 

$

16,418

 

0.8%

 

Stated as a Percentage of Net Sales

 

 

50.1%

 

 

69.9%

 

 

 

 

 

 

 

 

45.5%

 

 

53.0%

 

 

 

 

 

 


- 13 -



Selling, general and administrative expenses decreased $0.1 million, or 4.7%, duringexpensesduring the fourthree months ended June 30, 2017 compared to2018 were nearly even with the same period last year.  The decrease wasThis resulted from higher regulatory salary and benefits to meet our compliance activities, the resultaddition of a significant reductionclinical and medical affairs associate and consulting for FDA submissions and international registrations in aggregate $0.2 million.  Additionally we incurred higher consulting and recruiting fees for investor relations and the chief executive officer search of $0.1 million.  Mostly offsetting these increases were lower legal fees related to our litigation and regulatory efforts.  However, we cannot predict whether this trend will continue, nor can we predict the outcome of the litigation.  We are making every effort to manage the spend on professional fees while making sure we do whatever is necessary to achieve a positive outcome regarding out litigation and FDA matters.  We also had reductions in sales and marketing driven by reduced recruiting fees, lower consulting fees related to our website redesign last year, timing of spend this year on marketing initiatives$0.1 million and lower salary and related costsbenefits expense of $0.2 million due to attrition.  Partially offsetting these savings were increased coststhe termination of the chief operating officer last year and decreased headcount in our regulatory department due to headcount to support our regulatory compliance requirements.sales and marketing.


Research and development expense decreased by 54.5%, primarily due to attrition forexpenses are nearly even with the period.same period last year.  We are committed to our research and development activities and are actively searching to replace the open position.  We continue to actively pursuehired a new product development and enhance existing product lines based on demand from the marketplace which includes feedback from sales and marketing at RMS and our distributors, the RMS clinical advisory panel, and our strategic business partners.  We believe that such efforts have been usefulengineer in helping us to maintain our competitive position, increase revenue from our existing customer base and expand our market reach. Although our research and development efforts have allowed us to develop the Freedom60, our HIgH-Flo needle sets, and the FreedomEdge® in 2015, there can be no assurance that our research and development will result in additional commercially successful products.April 2018.


Depreciation and amortization


Depreciation and amortization expense increaseddecreased by 6.0% up1.0 % to $102,357$75,978 in the fourthree months ended June 30, 2018 compared with $76,781 in the three months ended June 30, 2017, compared with $96,577 in the four months ended June 30, 2016 as a result of decreased depreciation as more assets become fully depreciated offset by a continued investment in new computerproduction equipment, for both administrative support and for production requirements,increased amortization expense of new patent applications and maintenance of existing patents.


Net Income/(Loss)Income


 

Four Months Ended June 30,

 

Change from Prior Year

 

 

Three Months Ended June 30,

 

Change from Prior Year

 

 

2017

 

2016

 

$

 

 

2018

 

2017

 

$

 

Net Income/(Loss)

 

$

360,833

 

$

(205,882

)

$

566,715

 

Net Income

 

$

475,723

 

 

148,472

 

 

327,251

 

Stated as a Percentage of Net Sales

 

 

6.8%

 

 

(5.1%

)

 

 

 

 

 

10.6%

 

 

3.9%

 

 

 

 


Our net income for the fourthree months ended June 30, 2018 was $0.5 million compared to $0.1 million for the three months ended June 30, 2017, driven by higher net sales, level operating expenses and the impact of the new lower income tax rate.  Partially offsetting this was a negative foreign exchange effect of $54,508 versus last year.


- 13 -



Six months ended June 30, 2018 compared to June 30, 2017


Net Sales


The following table summarizes our net sales for the six months ended June 30, 2018 and 2017:


 

 

Six months Ended June 30,

 

Change from Prior Year

 

% of Sales

 

 

 

2018

 

2017

 

$

 

%

 

2018

 

2017

 

Sales

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Domestic

 

$

6,957,600

 

$

5,984,280

 

$

973,320

 

16.3%

 

81.5%

 

80.1%

 

International

 

 

1,577,950

 

 

1,483,613

 

 

94,337

 

6.4%

 

18.5%

 

19.9%

 

Total

 

$

8,535,550

 

$

7,467,893

 

$

1,067,657

 

14.3%

 

 

 

 

 


Total net sales increased $1.1 million or 14.3% for the six months ended June 30, 2018 driven largely by needle set sales.  We believe our 510(k) clearance described above contributed to the increase, as well as sales to our pharmaceutical partners for clinical trials which added $0.4 million for the six months.  


Gross Profit


Our gross profit for the six months ended June 30, 2018 and 2017 is as follows:


 

 

Six months Ended June 30,

 

Change from Prior Year

 

 

 

2018

 

2017

 

$

 

%

 

Gross Profit

 

$

5,205,408

 

$

4,399,254

 

$

806,154

 

18.3%

 

Stated as a Percentage of Net Sales

 

 

61.0%

 

 

58.9%

 

 

 

 

 

 


Gross profit increased $0.8 million or 18.3% in the six months ended June 30, 2018, compared to the same period last year. This increase was driven by the increase in net sales of $1.1 million.  Additionally, production operating efficiencies contributed to improved gross margin.


Selling, general and administrative and Research and development


Our selling, general and administrative expenses and research and development costs for the six months ended June 30, 2018 and 2017 are as follows:


 

 

Six months Ended September 30,

 

Change from Prior Year

 

 

 

2018

 

2017

 

$

 

%

 

Selling, general and administrative

 

$

3,902,900

 

$

3,780,445

 

$

122,455

 

3.2%

 

Research and development

 

 

33,811

 

 

70,746

 

 

(36,935

)

(52.2)%

 

 

 

$

3,936,711

 

$

3,851,191

 

$

85,520

 

2.2%

 

Stated as a Percentage of Net Sales

 

 

46.1%

 

 

51.6%

 

 

 

 

 

 


Selling, general and administrative expenses increased $0.1 million, or 3.2%, during the six months ended June 30, 2018 compared to the same period last year.  This resulted from higher regulatory salary and benefits to meet our compliance activities, the addition of a clinical and medical affairs associate and consulting fees for FDA submissions and international registrations in aggregate $0.3 million.  Additionally we incurred higher consulting and recruiting fees for investor relations and the chief executive officer search of $0.2 million.  Mostly offsetting these increases were lower salary and related benefits expense of $0.4 million due to the termination of the chief operating officer last year and decreased headcount in sales and marketing.


Research and development expense decreased by 52.2%, primarily due to attrition for the period compared with last year.  We have since hired an engineer.


Depreciation and amortization


Depreciation and amortization expense decreased by 0.7% to $150,556 in the six months ended June 30, 2018 compared with $151,662 in the six months ended June 30, 2017as a result of decreased depreciation as more assets become fully depreciated offset by a continued investment in production equipment, and increased amortization expense of new patent applications and maintenance of existing patents.


- 14 -



Net Income


 

 

Six months Ended June 30,

 

Change from Prior Year

 

 

 

2018

 

2017

 

$

 

Net Income

 

$

879,150

 

$

275,423

 

$

603,727

 

Stated as a Percentage of Net Sales

 

 

10.3%

 

 

3.7%

 

 

 

 


Our net income for the six months ended June 30, 2018 was $0.9 million compared to a net lossincome of $0.2$0.3 million for the foursix months ended June 30, 2016.2017.  This $0.6 million increasechange was mostly a result of the increase in net sales, and reduceda 2.2% increase in selling, general and administrative and research and development expenses as described above.  Additionally, the Company recognizedabove as well as a $54,659lower income tax rate.  Partially offsetting this was a negative foreign exchange gain for the period.effect of $62,158 versus last year.


LIQUIDITY AND CAPITAL RESOURCES


Our principal source of liquidity is our cash of $3.0$3.4 million as of June 30, 2017, and cash flows from operations.2018.  Our principal source of operating cash inflows is from sales of our products to customers.  Our principal cash outflows relate to the purchase and production of inventory and related costs, selling, general and administrative expenses, research and development costs, capital expenditures and patent costs.


We believe that as of June 30, 2017,2018, cash on hand and cash expected to be generated from future operating activities will be sufficient to fund our operations, including further research and development and capital expenditures, for the next 12 months.  We believe the FREEDOM System continues to find a solid following in the SCIg market, and this market is expected to continue to increase both domestically and internationally.  In addition, we expect many


On February 8, 2018, the Company executed a Promissory Note with KeyBank National Association in the amount of $1.5 million as a variable rate revolving line of credit loan due on demand with an interest rate of Libor plus 2.25%, collateralized with a certificate of deposit in the SCIg providers,amount of $1.5 million.  The Company entered into this arrangement to establish a credit lending history and, others, will see benefit in using the FREEDOM Systemevent needed, to have additional cash on hand for additional uses such as antibiotics, chemotherapeutics, and pain medications.future expansion.  As of June 30, 2018, the Company has no outstanding amounts against the line of credit.


We continue to be in litigation with a competitor, EMED Technologies Corp.Corporation (“EMED”) and have incurred a significant amount of legal fees in connection with that process.  Although the Company believes it has meritorious claims and defenses in the actions and proceedings, their outcomes cannot be predicted with any certainty. If any of these actions against the Company are successful, they could have a material adverse effect on the Company’s business, results of operations, financial condition and cash flows.


- 14 -



On September 30, 2015, RMS’s Board of Directors authorized the Company to make open market purchases of up to 2,000,000 shares of the Company’s Outstanding Common Stock.  The purchases are made through a broker designated by the Company, with price, timing and volume restrictions based on average daily trading volume, consistent with the rules of the Securities and Exchange Commission for such repurchases.  As of June 30, 2017, the Company had repurchased 396,606 shares at an average price of $0.45 under the program.  The management of the Company decided to discontinue repurchasing its outstanding common stock under the program for an undetermined period of time to utilize cash for capital investments needed to expand the business.


Cash Flows


The following table summarizes our cash flows:


 

 

Four Months Ended
June 30, 2017

 

Four Months Ended
June 30, 2016

 

Net cash used in operating activities

 

$

(236,636

)

$

(544,137

)

Net cash used in investing activities

 

$

(74,761

)

$

(103,634

)

Net cash used in financing activities

 

$

(19,360

)

$

(1,105

)

 

 

Six months Ended
June 30, 2018

 

Six months Ended
June 30, 2017

 

Net cash provided by/(used in) operating activities

 

$

955,787

 

$

(270,852

)

Net cash used in investing activities

 

$

(1,558,632

)

$

(143,979

)

Net cash provided by/(used in) financing activities

 

$

49,495

 

$

(19,844

)


Operating Activities


Net cash provided by operating activities of $1.0 million for the six months ended June 30, 2018 was primarily the result of net income of $0.9 million, non-cash charges of $0.2 million for depreciation and amortization of long lived tangible and intangible assets and stock based compensation of $0.1 million, as well as an increase in accounts payable of $0.3 million due to higher supplier payables.  Partially offsetting these were payments for insurance renewals, severance, bonus and commission payments.


Net cash used in operating activities of $0.2$0.3 million for the foursix months ended June 30, 2017 was primarily attributable to ouran increase in accounts receivable of $0.4 millionand$0.6 million and a decrease in accounts payable of $0.5 million mostly due to the payment of legal fees accrued for at February 28, 2017.  Partially offsetting these items werein the period.  Offsetting this was net income of $0.4$0.3 million, non-cash charges of $0.1$0.2 million for depreciation and amortization of long lived tangible, and intangible assets and stock based compensation of $41,479, a decrease in income tax receivable of $0.2 million.


Net cash used in operating activities of $0.6 million for the four months ended June 30, 2016 was primarily attributable to the operating loss of $0.2 million, an increase in accounts receivable of $0.4 million, an increase in prepaid expenseinventory of $0.1 million mostly due to an income tax receivable of $0.1 million due to the loss in the period, all partially offset by non-cash charges of $0.1 million for depreciation and amortization of long lived tangible and intangible assets, stock based compensation expense of $69,714 and an increase in accounts payable of $0.2 million mostly due to raw material purchases and legal fees.tax liability resulting from increased profits.


- 15 -



Investing Activities


Our net cash used for investing activities of $1.6 million for the six months ended June 30, 2018 was mostly the result of the purchase of a certificate of deposit.  Net cash used in investing activities of $0.1 million for the foursix months ended June 30, 2017 and June 30, 2016 was primarily attributable to our continued investment in capital assets, mostly related to production and computer equipment, and for new patent applications and maintenance of existing patents.


Financing Activities


Our netNet cash provided by financing activities was $49,495 for the six months ended June 30, 2018 mostly resulting from the exercise of options.  Net cash used in financing activities was $19,360 and $1,105$19,844 for the foursix months ended June 30, 2017 and June 30, 2016, respectively, bothmostly resulting from the resultcancellation of the repurchase of shares of the Company’s common stock.


FDA


RMS had an inspection by the FDA in June 2015, which included, among other items, a review of customer complaints, quality controls, quality assurance and documentation. The FDA inspection was then expanded as a consequence of an extensive “trade complaint” filed on behalf of a competitor which resulted in the issuance of an FDA FORM 483.   Eight months later, on February 29, 2016 we received a Warning Letter.  The Company responded and replied numerous times to the Warning Letter from March 18, 2016 on, and underwent a follow up inspection on November 29, 2016.  On December 16, 2016, the FDA issued another FDA FORM 483, to which the Company provided a written response on January 9, 2017 and provided a supplemental response on March 17, 2017 and April 24, 2017.  On April 25, 2017, RMS met with the FDA Center for Devices and Radiological Health (“CDRH”) Compliance team and the New York District Office to discuss the final resolution of Warning Letter closure.  On May 23, 2017, the Compliance Office of CDRH issued a letter to RMS to acknowledge that RMS had successfully addressed all quality and regulatory issues cited in the Warning Letter.  Prior to closing the Warning Letter, the FDA also needs to complete its review of our premarket submission (a pending 510(k)), which was accepted for review on May 17, 2017.  On June 30, 2017, RMS received a written response regarding our  pending 510(k) submission, and RMS is working with the Office for Device Evaluation of CDRH to address those questions in order receive the 510(k) clearance as expeditiously as possible.  


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On April 19, 2017, the FDA renewed our Certificate to Foreign Government which is used to communicate to foreign governments that the FDA certified that RMS meets good manufacturing practices and quality system regulations.  


Although the Company is attempting to meet all of the FDA requirements, we cannot be certain that our actions will be deemed satisfactory by the FDA and this could have a material adverse effect on the Company’s business, results of operations, financial condition and cash flows.shares.


RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS


In May 2017,June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2017-09—Compensation-Stock Compensation (Topic 718), which provides clarity and reduce both (1) diversity in practice and (2) cost and complexity when applying the guidance in Topic 718, Compensation—Stock Compensation, to a change to the terms or conditions of a share-based payment award.  The amendments in this update affect any entity that changes the terms or conditions of a share-based payment award. The amendments in this update are effective for all entities for annual periods, and interim periods within those annual periods, beginning after December 15, 2017.  Early adoption is permitted, including adoption in any interim period, for (1) public business entities for reporting periods for which financial statements have not yet been issued and (2) all other entities for reporting periods for which financial statements have not yet been made available for issuance. The amendments in this update should be applied prospectively to an award modified on or after the adoption date.  The Company is assessing the impact of the adoption of the ASU on its financial statements, disclosure requirements and methods of adoption.


In June 2016, FASB issued ASU No. 2016-13—Financial Instruments – Credit Losses (Topic 326); Measurement of Credit Losses on Financial Instruments, which amends guidance on reporting credit losses for assets held at amortized cost basis and available for sale debt securities.  For assets held at amortized cost basis, Topic 326 eliminates the probable initial recognition threshold in current GAAP and, instead, requires an entity to reflect its current estimate of all expected credit losses. The allowance for credit losses is a valuation account that is deducted from the amortized cost basis of the financial assets to present the net amount expected to be collected.  For available for sale debt securities, credit losses should be measured in a manner similar to current GAAP, however Topic 326 will require that credit losses be presented as an allowance rather than as a write-down.  This ASU affects entities holding financial assets and net investment in leases that are not accounted for at fair value through net income. The amendments affect loans, debt securities, trade receivables, net investments in leases, off balance sheet credit exposures, reinsurance receivables, and any other financial assets not excluded from the scope that have the contractual right to receive cash.  The amendments in this update are effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years.  The Company is assessing the impact of the adoption of the ASU on its financial statements, disclosure requirements and methods of adoption.


In May 2014, the FASB issued ASU No. 2014-09—Revenue from Contracts with Customers. The ASU clarifies the principles for recognizing revenue and develops a common revenue standard for U.S. GAAP and International Financial Reporting Standards (“IFRS”) that removes inconsistencies and weaknesses in revenue requirements, provides a more robust framework for addressing revenue issues, improves comparability of revenue recognition practices across entities, industries, jurisdictions and capital markets, provides more useful information to users of the financial statements through improved disclosure requirements and simplifies the preparation of financial statements by reducing the number of requirements to which an entity must refer. The amendments in this update are effective for the annual reporting periods beginning after December 15, 2016, including interim periods within that reporting period. Full or modified retrospective adoption is required and early application is not permitted. On July 9, 2015, the FASB issued ASU No. 2015-14 Revenue from Contracts with Customers (Topic 606); Deferral of the Effective Date, which (a) delays the effective date of ASU 2014-09, Revenue from Contracts with Customers (Topic 606), by one year to annual periods beginning after December 15, 2017 and (b) allows early adoption of the ASU by all entities as of the original effective date for public entities.  We currently anticipate adopting the new standard using the modified retrospective method beginning January 1, 2018.  In March 2016, the FASB issued ASU No. 2016-08 Revenue from Contracts with Customers (Topic 606); Principal versus Agent Considerations (Reporting Revenue Gross versus Net), which is intended to improve the operability and understandability of the implementation guidance on principal versus agent considerations and the effective date is the same as the requirements in ASU 2014-09.  In April 2016, the FASB issued ASU No. 2016-10 Revenue from Contracts with Customers (Topic 606); Identifying Performance Obligations and Licensing, which is intended to clarify identifying performance obligations and the licensing implementation guidance, while retaining the related principles for those areas and the effective date is the same as the requirements in ASU 2014-09.  In May 2016, FASB issued ASU No. 2016-12—Revenue from Contracts with Customers (Topic 606); Narrow-Scope Improvements and Practical Expedients, which is intended to not change the core principle of the guidance in Topic 606, but rather affect only the narrow aspects of Topic 606 by reducing the potential for diversity in practice at initial application and by reducing the cost and complexity of applying Topic 606 both at transition and on an ongoing basis.  The effective date and transition requirements for the amendments in


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this update are the same as the effective date and transition requirements for Topic 606 (and any other Topic amended by update 2014-09).    In December 2016, the FASB issued ASU No. 2016-20 Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers, which represents changes to make minor improvements to the Codification that are not expected to have a significant effect on current accounting practice or create a significant administrative cost to most entities.  This update is the final, combined version of Proposed Accounting Standards Updates 2016-240 and 2016-320 (both entitled Technical Corrections and Improvements), which have been deleted.  Based upon our initial evaluation, we do not expect the adoption of the standard and related amendments to have a material effect on our financial condition or results of operations.


In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842).  The main difference between the current requirement under GAAP and this ASU is the recognition of lease assets and lease liabilities by lessees for those leases classified as operating leases.  This ASU requires that a lessee recognize in the statement of financial position a liability to make lease payments (the lease liability) and a right-of-use asset representing its right to use the underlying asset for the lease term (other than leases that meet the definition of a short-term lease).  The liability will be equal to the present value of lease payments.  The asset will be based on the liability, subject to adjustment, such as for initial direct costs.  For income statement purposes, the FASB retained a dual model, requiring leases to be classified as either operating or finance.  Operating leases will result in straight-line expense (similar to current operating leases) while finance leases will result in a front-loaded expense pattern (similar to current capital leases).  Classification will be based on criteria that are largely similar to those applied in current lease accounting.  For lessors, the guidance modifies the classification criteria and the accounting for sales-type and direct financing leases.  This is effective for annual and interim periods beginning after December 15, 2018 and early adoption is permitted.  This ASU must be adopted using a modified retrospective transition, and provides for certain practical expedients.  Transition will require application of the new guidance at the beginning of the earliest comparative period presented.  We are currently assessing the potential impact of this ASU on our financial statements, disclosure requirements and methods of adoption.


The Company considers the applicability and impact of all recently issued accounting pronouncements.  Recent accounting pronouncements not specifically identified in our disclosures are either not applicable to the Company or are not expected to have a material effect on our financial condition or results of operations.


PART I – ITEM 3.  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.


Not Applicable.


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PART I – ITEM 4.  CONTROLS AND PROCEDURES.


The Company’s management, including the Company’s Principal Executive Officer and Principal Financial Officer, have evaluated the effectiveness of the Company’s disclosure controls and procedures as such is defined in Rule 13a-15(e) promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”).  Based upon their evaluations, the Principal Executive Officer and Principal Financial Officer concluded that, as of the end of the period covered by this report, the Company’s disclosure controls and procedures were effective for the purpose of ensuring that the information required to be disclosed in the reports that the Company files or submits under the Exchange Act with the Securities and Exchange Commission (the “SEC”) (1) is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and (2) is accumulated and communicated to the Company’s management, including its Principal Executive Officer and Principal Financial Officer, as appropriate to allow timely decisions regarding required disclosure.


There have been no changes in the Company’s internal control over financial reporting during the quarter ended June 30, 2017,2018, that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.


PART II – OTHER INFORMATION


PART II – ITEM 2.  UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.


On October 21, 2015, the Board of Directors of the Company approved non-employee director compensation of $25,000 each annually, to be paid quarterly half in cash and half in common stock, beginning September 1, 2015.  The number of shares to be issued each quarter is calculated based upon the closing price of the common stock on the last day of each fiscal quarter as reported by the OTCQX.  The Company issued an aggregate of 44,11814,424 and 29,424 shares of common stock to its non-employee directors during the fourthree and six month period ended June 30, 2017.2018, respectively.


As of June 30, 2017, theThe Company issued an aggregate of 13,55511,538 and 23,538 shares of common stock to Dr. Fred Ma, its Chief Medical Officer, under the terms of his employment agreement.agreement, during the three and six month periods ended June 30, 2018, respectively.


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On June 29, 2016, RMS’s Board of Directors authorized the Company to make open market purchases of up to 2,000,000 shares of the Company’s outstanding Common Stock.  The following table provides information regarding repurchasespurchases are made through a broker designated by the Company, with price, timing and volume restrictions based on average daily trading volume, consistent with the rules of itsthe Securities and Exchange Commission for such repurchases. As of June, 2018, the Company had repurchased 396,606 shares at an average price of $0.45.  There were no repurchases of common stock by the Company during the three month periodquarter ended June 30, 2017:


Issuer Purchases2018.  The management of the Company has decided to discontinue repurchasing its outstanding Common Stock for an undetermined period of time to utilize cash for capital investments needed to expand the business.  There is no expiration date to the repurchase plan.


 

 

 

 

 

 

Total Number

 

Maximum

 

 

 

 

 

 

 

of Shares

 

Number of

 

 

 

Total

 

 

 

Purchased as

 

Shares that May

 

 

 

Number of

 

Average

 

Part of Publicly

 

Yet Be

 

 

 

Shares

 

Price Paid

 

Announced

 

Purchased

 

Period (1)

 

Purchased (2)

 

Per Share

 

Plan (3)

 

Under the Plan (3)

 

March 1, 2017 – March 31, 2017

 

 

 

 

 

1,603,394

 

April 1, 2017 – April 30, 2017

 

 

 

 

 

1,603,394

 

May 1, 2017 – May 31, 2017

 

44,000

 

$

0.44

 

 

1,603,394

 

June 1, 2017 – June 30, 2017

 

 

 

 

 

1,603,394

 

Total

 

44,000

 

$

0.44

 

 

 

 

__________

(1)

Monthly information is presented by reference to the Company’s fiscal months for the four months ended June 30, 2017.

(2)

In May 2017, the Company repurchased 44,000 shares of the Company’s common stock owned by two terminated employees at an aggregate purchase price of $19,360.

(3)

On September 30, 2015, RMS’s Board of Directors authorized the Company to make open market purchases of up to 2,000,000 shares of the Company’s Outstanding Common Stock.  The purchases are made through a broker designated by the Company, with price, timing and volume restrictions based on average daily trading volume, consistent with the rules of the Securities and Exchange Commission for such repurchases. As of June 30, 2017, the Company had repurchased 396,606 shares at an average price of $0.45 under the program.  The management of the Company decided to discontinue repurchasing its outstanding common stock under the program for an undetermined period of time to utilize cash for capital investments needed to expand the business.  There is no expiration date to the program.


On September 30, 2015,June 29, 2016, the Board of Directors approvedamended the 2015 Stock Option Plan authorizing the Company to grant awards to certain employees under the plan at fair market value, which was approved by shareholders at the Annual Meeting held on September 6, 2016.  The total number of shares of Common Stock, with respect to which awards may be granted pursuant to the Plan, shall not exceed 4,000,000 shares.  As of June 30, 2017,2018, there were outstanding 1.1 million931,000 options awarded to certain executives, key employees and advisory board members under the Plan.


All of the securities issued by the Company as described in this Item were issued in reliance on the exemption from registration under Section 4(2) under the Securities Act of 1933, as amended.


PART II – ITEM 6.  EXHIBITS.


31.1

Certification of Principal Executive Officer Pursuant to Section 302 of Sarbanes-Oxley Act 2002

 

 

31.2

Certification of Principal Financial Officer Pursuant to Section 302 of Sarbanes-Oxley Act 2002

 

 

32.1

Certification of Principal Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act 2002

 

 

32.2

Certification of Principal Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act 2002

 

 

101*

Interactive Data Files of Financial Statements and Notes.


* In accordance with Regulation S-T, the Interactive Data Files in Exhibit 101 to the Quarterly Report on Form 10-Q shall be deemed “furnished” and not “filed”.


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SIGNATURES


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



 

REPRO MED SYSTEMS, INC.

 

 

August 4, 20176, 2018

/s/ Andrew I. SealfonDaniel S. Goldberger

 

Andrew I. Sealfon, President,Daniel S. Goldberger, Chairman of the Board, Director,Interim President and Chief Executive Officer

 

 

August 4, 20176, 2018

/s/ Karen Fisher

 

Karen Fisher, Chief Financial Officer and Treasurer


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