UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

xQUARTERLY Report PURSUANT TO Section 13 or 15(d) of the Securities Exchange Act of 1934

þ   QUARTERLY Report PURSUANT TO Section 13 or 15(d) of the Securities Exchange Act of 1934

For the quarterly period ended DecemberMarch 31, 20132014

 

or

 

¨Transition Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

¨   Transition Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

For the transition period from __________ to ____________

 

Commission File No. 001-33407

 

ISORAY, INC.

(Exact name of registrant as specified in its charter)

 

Minnesota41-1458152
(State or other jurisdiction of incorporation or(I.R.S. Employer
organization)Identification No.)
  
350 Hills St., Suite 106, Richland, Washington99354
(Address (Address of principal executive offices)(Zip Code)
Registrant's telephone number, including area code:(509) 375-1202

 

Registrant's telephone number, including area code:(509) 375-1202

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 the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No Noo¨

 

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 such shorter period that the registrant was required to submit and post such files).Yesx No¨

 

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

Large accelerated filero Accelerated filero Non-accelerated filero

Smaller reporting companyx

Large accelerated filer¨ Accelerated filer¨Non-accelerated filer¨
Smaller reporting companyx

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act): Yes ¨o Nox

 

Number of shares outstanding of each of the issuer's classes of common equity as of the latest practicable date:

 

ClassOutstanding as of February 6,May 7, 2014
Common stock, $0.001 par value41,540,98254,392,781

 

 
 

 

ISORAY, INC.

 

Table of Contents

 

PART IFINANCIAL INFORMATION 
   
Item 1Consolidated Unaudited Financial Statements1
   
 Consolidated Balance Sheets1
Consolidated Statements of Operations (Unaudited)  2
Consolidated Statements of Cash Flows (Unaudited)3
   
 Consolidated Statements of Operations (Unaudited)4
Consolidated Statements of Cash Flows (Unaudited)5
Notes to Unaudited Consolidated Financial Statements46
   
Item 2Management’s Discussion and Analysis of Financial
Condition and Results of Operations1113
   
Item 3Quantitative and Qualitative Disclosures About Market Risk2123
   
Item 4Controls and Procedures2123
   
PART IIOTHER INFORMATION24
   
Item 1ARisk Factors2224
   
Item 2Unregistered Sales of Equity Securities and Use of Proceeds2224
Item 5Other Information24
   
Item 6Exhibits2325
   
Signatures 2426

 

2
 

 

PART I – FINANCIAL INFORMATION

  

IsoRay, Inc. and Subsidiaries

Consolidated Balance Sheets

 

 (Unaudited)    (Unaudited)    
 December 31, June 30,  March 31, June 30, 
 2013 2013  2014 2013 
          
ASSETS             
             
Current assets:             
Cash and cash equivalents $4,414,572 $2,899,927  $23,702,901  $2,899,927 
Accounts receivable, net of allowance for doubtful accounts     
of $32,515 and $52,598, respectively 917,222 923,780 
Accounts receivable, net of allowance for doubtful accounts of $71,377 and $52,598, respectively  805,326   923,780 
Inventory 426,333 405,571   387,020   405,571 
Other receivables 10,064 11,502 
Prepaid expenses and other current assets  156,365  202,880   212,079   214,382 
             
Total current assets 5,924,556 4,443,660   25,107,326   4,443,660 
             
Fixed assets, net of accumulated depreciation and amortization 1,349,469 1,684,282   1,183,067   1,684,282 
Restricted cash 181,181 181,149   181,194   181,149 
Inventory, non-current 469,758 469,758   469,758   469,758 
Other assets, net of accumulated amortization  262,698  276,507   258,619   276,507 
             
Total assets $8,187,662 $7,055,356  $27,199,964  $7,055,356 
             
LIABILITIES AND SHAREHOLDERS' EQUITY             
             
Current liabilities:             
Accounts payable and accrued liabilities $430,293 $432,566  $609,761  $432,566 
Accrued protocol expense 46,973 25,305   75,057   25,305 
Accrued radioactive waste disposal 124,000 100,000   130,301   100,000 
Accrued payroll and related taxes 141,082 127,419   87,660   127,419 
Accrued vacation  104,932  107,578   117,971   107,578 
             
Total current liabilities  847,280  792,868   1,020,750   792,868 
             
Warrant derivative liability 23,000 104,000   678,000   104,000 
Asset retirement obligation  828,568  792,242   847,351   792,242 
             
Total liabilities  1,698,848  1,689,110   2,546,101   1,689,110 
             
Commitments and contingencies (Note 6)             
             
Shareholders' equity:             
Preferred stock, $.001 par value; 7,001,671 shares authorized:             
Series A: 1,000,000 shares allocated; no shares issued and outstanding - -   -   - 
Series B: 5,000,000 shares allocated; 59,065 shares issued and outstanding 59 59   59   59 
Series C: 1,000,000 shares allocated; no shares issued and outstanding - -   -   - 
Series D: 1,671 and 0 shares allocated; 1,670 & 0 shares issued and outstanding 2 - 
Common stock, $.001 par value; 192,998,329 & 193,000,000 shares authorized;     
38,419,502 and 34,618,517 shares issued and outstanding 38,420 34,618 
Series D: 1,671 and 0 shares allocated; no shares issued and outstanding  -   - 
Common stock, $.001 par value; 192,998,329 & 193,000,000 shares authorized; 54,181,444 and 34,618,517 shares issued and outstanding  54,181   34,618 
Treasury stock, at cost, 13,200 shares (8,390) (8,390)  (8,390)  (8,390)
Additional paid-in capital 60,747,935 57,431,293   80,980,664   57,431,293 
Accumulated deficit  (54,289,212)  (52,091,334)  (56,372,651)  (52,091,334)
             
Total shareholders' equity  6,488,814  5,366,246   24,653,863   5,366,246 
             
Total liabilities and shareholders' equity $8,187,662 $7,055,356  $27,199,964  $7,055,356 

 

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

1

IsoRay, Inc. and Subsidiaries

Consolidated Statements of Operations

(Unaudited)

 

 Three months ended December 31, Six months ended December 31,  Three months ended March 31,  Nine months ended March 31, 
 2013 2012 2013 2012  2014  2013  2014  2013 
                  
Product sales $1,085,408 $975,457 $2,135,323 $2,031,689  $1,134,319  $1,251,478  $3,269,642  $3,283,167 
Cost of product sales  1,119,314  1,134,083  2,246,537  2,210,740   1,083,413   1,065,574   3,329,950   3,276,314 
                         
Gross loss  (33,906)  (158,626)  (111,214)  (179,051)
Gross profit / (loss)  50,906   185,904   (60,308)  6,853 
                         
Operating expenses:                         
Research and development expenses 170,030 149,176 317,020 290,648   153,611   155,137   470,631   445,785 
Sales and marketing expenses 326,467 322,094 685,652 638,150   245,558   290,812   931,210   928,962 
General and administrative expenses  513,964  469,559  1,165,000  1,114,412   640,732   564,075   1,805,732   1,678,487 
                         
Total operating expenses  1,010,461  940,829  2,167,672  2,043,210   1,039,901   1,010,024   3,207,573   3,053,234 
                         
Operating loss  (1,044,367)  (1,099,455)  (2,278,886)  (2,222,261)  (988,995)  (824,120)  (3,267,881)  (3,046,381)
                         
Non-operating income (expense):                         
Interest income 481 128 835 272   556   83   1,391   355 
Change in fair value of warrant derivative liability 117,000 (55,000) 81,000 74,000   (1,095,000)  109,000   (1,014,000)  183,000 
Financing and interest expense  (86)  -  (827)  (6)  -   -   (827)  (6)
                         
Non-operating income / (expense), net  117,395  (54,872)  81,008  74,266   (1,094,444)  109,083   (1,013,436)  183,349 
                         
Net loss (926,972) (1,154,327) (2,197,878) (2,147,995)  (2,083,439)  (715,037)  (4,281,317)  (2,863,032)
Preferred stock deemed dividends (Note 9) - - (726,378) -   -   -   (726,378)  - 
Preferred stock dividends  (2,658)  (2,658)  (5,316)  (5,316)  (2,658)  (2,658)  (7,974)  (7,974)
                         
Net loss applicable to common shareholders $(929,630) $(1,156,985) $(2,929,572) $(2,153,311) $(2,086,097) $(717,695) $(5,015,669) $(2,871,006)
                         
Basic and diluted loss per share $(0.02) $(0.03) $(0.08) $(0.06) $(0.05) $(0.02) $(0.13) $(0.08)
                         
Weighted average shares used in computing net loss per share:                         
Basic and diluted  38,419,502  34,604,605  37,133,875  34,238,401   42,506,077   34,611,517   38,852,980   34,359,567 

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

IsoRay, Inc. and Subsidiaries

Consolidated Statements of Cash Flows

(Unaudited)

  Nine months ended March 31, 
  2014  2013 
       
CASH FLOWS FROM OPERATING ACTIVITIES:        
Net loss $(4,281,317) $(2,863,032)
Adjustments to reconcile net loss to net cash used by operating activities:        
Allowance for doubtful accounts  18,779   (32,174)
Depreciation and amortization of fixed assets  517,548   563,850 
Amortization of deferred financing costs and other assets  23,056   21,036 
Change in fair value of warrant derivative liability  1,014,000   (183,000)
Accretion of asset retirement obligation  55,109   50,383 
Share-based compensation  65,217   85,369 
Changes in operating assets and liabilities:        
Accounts receivable, gross  99,675   67,195 
Inventory  18,551   87,368 
Other receivables  4,516   2,204 
Prepaid expenses and other current assets  (2,213)  (69,427)
Accounts payable and accrued expenses  177,195   (21,525)
Accrued protocol expense  49,752   27,500 
Accrued radioactive waste disposal  30,301   36,000 
Accrued payroll and related taxes  (39,759)  (54,654)
Accrued vacation  10,393   12,961 
         
Net cash used by operating activities  (2,239,197)  (2,269,946)
         
CASH FLOWS FROM INVESTING ACTIVITIES:        
Purchases of fixed assets  (16,333)  - 
Additions to licenses and other assets  (5,168)  (12,926)
Change in restricted cash  (45)  (104)
         
Net cash used by investing activities  (21,546)  (13,030)
         
CASH FLOWS FROM FINANCING ACTIVITIES:        
Preferred dividends paid  (10,632)  (10,632)
Proceeds from sales of preferred stock, pursuant to underwritten offering, net  1,478,703   - 
Proceeds from sales of common stock, pursuant to underwritten offering, net  1,800,589   - 
Proceeds from sales of common stock, pursuant to registered direct offering, net  13,818,927   3,291,977 
Proceeds from sales of common stock, pursuant to exercise of warrants, net  5,961,001   1,825 
Proceeds from sales of common stock, pursuant to exercise of options  15,129   11,309 
         
Net cash provided by financing activities  23,063,717   3,294,479 
         
Net increase in cash and cash equivalents  20,802,974   1,011,503 
Cash and cash equivalents, beginning of period  2,899,927   2,672,711 
         
CASH AND CASH EQUIVALENTS, END OF PERIOD $23,702,901  $3,684,214 
         
Non-cash investing and financing activities:        
Reclassification of derivative warrant liability to equity upon exercise $(440,000) $- 
Reclassification of convertible preferred stock to common stock upon conversion  (1,478,703)    

 

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

  

25
 

 

IsoRay, Inc. and Subsidiaries

 Consolidated Statements of Cash Flows

 (Unaudited)

  Six months ended December 31, 
  2013  2012 
       
CASH FLOWS FROM OPERATING ACTIVITIES:        
Net loss $(2,197,878) $(2,147,995)
Adjustments to reconcile net loss to net cash used by operating activities:        
Allowance for doubtful accounts  (20,083)  (13,477)
Depreciation and amortization of fixed assets  349,232   388,171 
Amortization of deferred financing costs and other assets  15,371   14,024 
Change in fair value of warrant derivative liability  (81,000)  (74,000)
Accretion of asset retirement obligation  36,326   33,211 
Share-based compensation  51,786   57,789 
Changes in operating assets and liabilities:        
Accounts receivable, gross  26,641   222,365 
Inventory  (20,762)  41,433 
Other receivables  1,438   1,914 
Prepaid expenses and other current assets  46,515   (84,252)
Accounts payable and accrued expenses  (2,273)  4,120 
Accrued protocol expense  21,668   13,750 
Accrued radioactive waste disposal  24,000   24,000 
Accrued payroll and related taxes  13,663   9,181 
Accrued vacation  (2,646)  (3,230)
         
Net cash used by operating activities  (1,738,002)  (1,512,996)
         
CASH FLOWS FROM INVESTING ACTIVITIES:        
Purchases of fixed assets  (14,419)  - 
Additions to licenses and other assets  (1,562)  (13,407)
Change in restricted cash  (32)  (84)
         
Net cash used by investing activities  (16,013)  (13,491)
         
CASH FLOWS FROM FINANCING ACTIVITIES:        
Preferred dividends paid  (10,632)  (10,632)
Proceeds from sales of preferred stock, pursuant to underwritten offering, net  1,478,712   - 
Proceeds from sales of common stock, pursuant to underwritten offering, net  1,800,580   - 
Proceeds from sales of common stock, pursuant to registered direct offering, net  -   3,291,977 
Proceeds from sales of common stock, pursuant to exercise of warrants, net  -   1,825 
Proceeds from sales of common stock, pursuant to exercise of options  -   11,309 
         
Net cash provided by financing activities  3,268,660   3,294,479 
         
Net increase in cash and cash equivalents  1,514,645   1,767,992 
Cash and cash equivalents, beginning of period  2,899,927   2,672,711 
         
CASH AND CASH EQUIVALENTS, END OF PERIOD $4,414,572  $4,440,703 

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

3

IsoRay, Inc.

Notes to the Unaudited Consolidated Financial Statements

For the three and sixnine months ended DecemberMarch 31, 20132014 and 20122013

 

1.Basis of Presentation

 

The accompanying consolidated financial statements are those of IsoRay, Inc., and its wholly-owned subsidiaries (IsoRay or the Company). All significant intercompany accounts and transactions have been eliminated in consolidation. Certain amounts in the prior-year financial statements have been reclassified to conform to the current year presentation.

 

In the opinion of management, the accompanying unaudited interim consolidated financial statements and notes to the interim consolidated financial statements contain all adjustments, consisting of normal recurring items, necessary to present fairly, in all material respects, the financial position of IsoRay, Inc. and its wholly-owned subsidiaries.  These unaudited interim consolidated financial statements should be read in conjunction with our audited consolidated financial statements and related footnotes as set forth in the Company’s annual report filed on Form 10-K for the year ended June 30, 2013, as it may be amended from time to time.

 

The results of operations for the periods presented may not be indicative of those which may be expected for a full year.  The unaudited consolidated financial statements have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission.  Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) have been condensed or omitted pursuant to those rules and regulations, although we believe that the disclosures are adequate for the information not to be misleading.

 

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities as of the date of the financial statements, the reported amounts of revenues and expenses during the reporting period and the disclosures of contingent liabilities.  Accordingly, ultimate results could differ materially from those estimates.

 

2.New Accounting Pronouncements

 

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (the “FASB”) or other standards setting bodies that are adopted by us as of the specified effective dates. Unless otherwise discussed, we believe the impact of recently issued standards that are not yet effective will not have a material impact on our consolidated financial position, results of operations and cash flows upon adoption.

 

3.Loss per Share

 

Basic earnings per share is calculated by dividing net income (loss) available to common shareholders by the weighted average number of common shares outstanding, and does not include the impact of any potentially dilutive common stock equivalents. Common stock equivalents, including warrants and options to purchase the Company's common stock, are excluded from the calculations when their effect is antidilutive. At DecemberMarch 31, 20132014 and 2012,2013, the calculation of diluted weighted average shares did not include preferred stock, common stock warrants, or options that are potentially convertible into common stock as those would be antidilutive due to the Company’s net loss position.

Securities presented on an as-converted to common stock basis, not considered in the calculation of diluted weighted average shares, but that could be dilutive in the future as of DecemberMarch 31, 20132014 and 2012,2013, were as follows:

    

 December 31,  March 31, 
 2013  2012  2014 2013 
Series B preferred stock  59,065   59,065   59,065   59,065 
Series D preferred stock  3,121,480   - 
Common stock warrants  7,605,771   1,957,033   646,811   1,957,033 
Common stock options  2,370,072   2,312,072   2,324,072   2,312,072 
                
Total potential dilutive securities  13,156,388   4,328,170   3,029,948   4,328,170 

 

4.Inventory

 

Inventory consisted of the following at DecemberMarch 31, 20132014 and June 30, 2013:

    

 December 31, June 30,  March 31, June 30, 
 2013  2013  2014 2013 
Raw materials $168,731  $167,671  $165,657  $167,671 
Work in process  212,726   195,323   181,457   195,323 
Finished goods  44,876   42,577   39,906   42,577 
                
Total inventory $426,333  $405,571 
 $387,020  $405,571 

 

5.Share-Based Compensation

 

The following table presents the share-based compensation expense recognized during the three and sixnine months ended DecemberMarch 31, 20132014 and 2012:2013:

 

 Three months Six months 
 ended December 31, ended December 31,  Three months
ended March 31,
 Nine months
 ended March 31,
 
 2013  2012  2013  2012  2014 2013 2014 2013 
Cost of product sales $4,499  $10,164  $8,921  $20,328  $4,500  $10,164  $13,421  $30,492 
Research and development expenses  3,482   8,717   6,965   17,435   3,482   7,607   10,447   25,042 
Sales and marketing expenses  879   1,523   1,757   3,182   879   1,386   2,636   4,568 
General and administrative expenses  4,572   8,422   34,141   16,844   4,572   8,423   38,713   25,267 
Total share-based compensation $13,432  $28,826  $51,784  $57,789  $13,433  $27,580  $65,217  $85,369 

 

As of DecemberMarch 31, 2013,2014, total unrecognized compensation expense related to stock-based options was $42,626$29,192 and the related weighted-average period over which it is expected to be recognized is approximately 0.820.87 years.

 

The Company currently provides stock-based compensation under threefour equity incentive plans approved by the Board of Directors. Options granted under each of the plans have a ten year maximum term, an exercise price equal to at least the fair market value of the Company’s common stock on the date of the grant, and varying vesting periods as determined by the Board. For stock options with graded vesting terms, the Company recognizes compensation cost on a straight-line basis over the requisite service period for the entire award.

A summary of stock options within the Company’s share-based compensation plans as of DecemberMarch 31, 20132014 was as follows:

 

        Weighted    
     Weighted  Average    
  Average  Remaining  Aggregate    
  Number of  Exercise  Contractual  Intrinsic 
  Options  Price  Term  Value 
             
Outstanding at December 31, 2013  2,370,072  $1.79   4.57  $125,884 
Vested and expected to vest at                
December 31, 2013  2,278,260  $1.84   4.50  $114,801 
Vested and exercisable at                
December 31, 2013  2,080,064  $1.90   4.13  $125,784 
        Weighted    
     Weighted  Average    
     Average  Remaining  Aggregate 
  Number of  Exercise  Contractual  Intrinsic 
  Options  Price  Term  Value 
             
Outstanding at March 31, 2014  2,324,072  $1.82   4.3  $2,050,334 
Vested and expected to vest at March 31, 2014  2,238,840  $1.86   4.23  $1,923,611 
Vested and exercisable at March 31, 2014  2,040,732  $1.93   3.85  $1,714,527 

 

There were no26,333 options exercised during the sixnine months ended DecemberMarch 31, 20132014 and 31,700 options exercised during the sixnine months ended DecemberMarch 31, 2012.2013. The Company’s current policy is to issue new shares to satisfy option exercises. The intrinsic value of the employee options exercised during the sixnine months ended DecemberMarch 31, 20122014 was $15,130 and the nine months ended March 31, 2013 was $13,866.

 

There were 65,000 stock option awards granted and no stock option awards granted during the sixnine months ended DecemberMarch 31, 20132014 and 2012,2013, respectively.

 

ThereOf the 65,000 options, 50,000 were 50,000 director stock options issued to the Chief Executive Officer and Chairman on September 5, 2013 with an exercise price of $0.58 per share which was the closing price of the Company common stock on the day of issuance. The fair value of the stock options issued on September 5, 2013 using a Black Scholes model is $25,150 utilizing the closing price on the day of grant of $0.58 per share as the grant and exercise price, a five year term, volatility of 132.31% and a discount rate of 1.85%.

 

ThereThe remaining 15,000 were 15,000 employee stock options issued to three members of management on September 6, 2013 with an exercise price of $0.59 per share which was the closing price of the Company common stock on the day of issuance. The fair value of the stock options issued on September 6, 2013 using a Black Scholes model is $6,906 utilizing the closing price on the day of grant of $0.59 per share as the grant and exercise price, a five year term, volatility of 132.31% and a discount rate of 1.77%.

 

6.Commitments and Contingencies

 

Patent and Know-How Royalty License Agreement

 

The Company is the holder of an exclusive license to use certain “know-how” developed by one of the founders of a predecessor to the Company and licensed to the Company by the Lawrence Family Trust, a Company shareholder. The terms of this license agreement require the payment of a royalty based on the Net Factory Sales Price, as defined in the agreement, of licensed product sales. Because the licensor’s patent application was ultimately abandoned, only a 1% “know-how” royalty based on Net Factory Sales Price, as defined in the agreement, remains applicable. To date, management believes that there have been no product sales incorporating the “know-how” and therefore no royalty is due pursuant to the terms of the agreement. Management believes that ultimately no royalties should be paid under this agreement as there is no intent to use this “know-how” in the future.

The licensor of the “know-how” has disputed management’s contention that it is not using this “know-how”. On September 25, 2007 and again on October 31, 2007, the Company participated in nonbinding mediation regarding this matter; however, no settlement was reached with the Lawrence Family Trust. After additional settlement discussions, which ended in April 2008, the parties failed to reach a settlement. The parties may demand binding arbitration at any time.

 

7.Fair Value Measurements

 

The table below sets forth the Company’s financial assets and liabilities that were accounted for at fair value on a recurring basis as of DecemberMarch 31, 20132014 and June 30, 2013, respectively, and the fair value calculation input hierarchy level the Company has determined applies to each asset and liability category. 

 

 Balance at Balance at Input
Description December 31, 2013  June 30, 2013  Hierarchy Level Balance at
March 31, 2014
  Balance at
June 30, 2013
 Input
Hierarchy Level
Assets:                
Cash and cash equivalents $4,414,572  $2,899,927  Level 1 $23,702,901  $2,899,927  Level 1
Restricted cash  181,181   181,149  Level 1  181,194   181,149  Level 1
                    
Liabilities:                    
Warrant liability $23,000  $104,000  Level 2 $678,000  $104,000  Level 2

 

8.Preferred Dividends

 

On December 19, 2013, the Board of Directors declared a dividend on the Series B Preferred Stock of all currently payable and accrued outstanding and cumulative dividends through December 31, 2013 in the amount of $10,632. Dividends on the Series B Preferred Stock were last paid on December 31, 2012 as declared by the Board of Directors on December 21, 2012 in the amount of $10,632. The dividends outstanding and cumulative through December 31, 2013 of $10,632 and through December 31, 2012 of $10,632 were paid as of those dates.

 

9.Shareholders’ Equity

Common and preferred stock transactions

Series D

 

On August 29, 2013, the Company entered into an agreement to sell 3,800,985 common units, each consisting of 1 share of common stock and a warrant to purchase 0.816 shares of common stock (the “Common Units”), and 1,670 preferred units, each consisting of 1 share of Series D Convertible Preferred Stock and a warrant to purchase 1,525.23 shares of common stock (the “Preferred Units”) on a firm commitment underwritten basis. The Common Units were sold at an initial per unit purchase price of $0.535 and the Preferred Units were sold at an initial per unit purchase price of $1,000. The warrants arewere all exercisable at $0.72 per share are callable, and havehad a twenty-four month term, with the exercise price and term subject to reduction if shareholder approval is obtained, and are not exercisable until March 1, 2014.term. Each share of the Series D Convertible Preferred Stock iswas convertible into 1,869.15 shares of common stock at any time at the option of the holder, subject to adjustment provided that the holder will be prohibited from converting Series D Convertible Preferred Stock into shares of the Company's common stock if, as a result of such conversion, the holder, together with affiliates, would own more than 9.99% of the total shares of the Company's common stock then issued and outstanding.certain ownership percentage restrictions. The preferred shares which arewere convertible into shares of common stock containcontained a beneficial conversion feature of $726,378 which was recognized as a deemed dividend to the Series D preferred shareholders on the date of issuance. This public offering resulted in gross proceeds of $3.7 million. The offering yielded approximately $3,279,292 in cash after expenses.

Gross proceeds from public offering $3,703,527 
Underwriting discount  (185,176)
Legal and accounting expense  (184,514)
Listing expense  (48,500)
Other expense  (6,045)
Net proceeds  3,279,292 

 

Series D

Series D convertible preferredDuring January 2014, the holder of the 1,670 shares are entitled to dividends in the same form as dividends actually paid on shares of common stock. Series D convertible preferred shares are convertible into shares of common stock at the rate of 1,869.15 shares of common stock for each share of Series D convertible preferred stock (subjectfully exercised its right to adjustment as provided inconvert the certificate of designation for the Series D Convertible Preferred Stock), and are subject to conversion limitations if the conversion would result in the holder together with its affiliates, beneficially owning more than 9.99% of the total number of1,670 shares of our common stock then issued and outstanding. Series D convertible preferred shareholders shall not havestock into 3,121,480 shares of common stock which at the righttime of conversion resulted in an increase in shares of common stock outstanding from 38,419,502 to vote on any matter other than those set forth in41,540,982. Subsequent to the Certificateconversion, no shares of DesignationSeries D convertible preferred stock remain outstanding.

Common Stock

On March 21, 2014, the Company entered into a Securities Purchase Agreement with certain investors providing for the potentialsale of a total of 5,644,300 shares of common stock for an aggregate purchase price of $14,675,180 at a price per share of $2.60 (the “Registered Direct Offering”). The Company received net proceeds from the offering of approximately $13,818,927 from the Registered Direct Offering which will be used to specifically adversely affectmeet the Company’s working capital needs and general corporate purposes.

Gross proceeds from registered direct offering $14,675,180 
Placement agent fees  (733,759)
Legal and accounting expense  (72,494)
Listing expense  (45,000)
Other expense  (5,000)
Net proceeds  13,818,927 

Warrant exercises

During the month of March 2014, the holder of the Series D Convertible Preferred Stock.warrants issued in November 2010 exercised its right to purchase 1,050,000 shares of common stock. Each warrant had an exercise price of $1.56 per share of Company common stock and the exercise contributed $1,638,000 in total additional cash and equity.

 

UponDuring the executionmonth of a fundamental transaction which effects a merger or other change of control transactionMarch 2014, certain holders of the warrants to purchase Company a holder will havecommon stock issued in the October and December 2011 equity transaction exercised their right to receive, upon anypurchase 37,574 shares of common stock. Each warrant had an original exercise price of $1.053 that was reduced in accordance with the terms of the warrant for dilution as the result of subsequent conversionofferings to a revised exercise price of a$0.944 per share of Series D Convertible Preferred Stock (in lieuCompany common stock. This created a liability of conversion shares)$35,470 as the stock had not been issued by the transfer agent as of the end of March, however, shares of common stock were issued during April in compliance with the contractual terms of the warrant.

During the month of March 2014, certain holders of the warrants to purchase Company common stock issued in the October and December 2011 equity transaction exercised their right to purchase 271,091 shares of common stock. Each warrant had an original exercise price of $1.053 that was reduced in accordance with the terms of the warrant for each issuable conversiondilution as the result of subsequent offerings to a current exercise price of $0.944 per share of Company common stock and the same kindexercise contributed $255,910 in total additional cash and amountequity.

During the month of securities,March 2014, the holders of the warrants to purchase Company common stock issued in the August 2013 equity transaction exercised their right to purchase 5,648,738 shares of common stock. Each warrant had an exercise price of $0.72 per share of Company common stock and the exercise contributed $4,067,091 in total additional cash or property as it would have been entitled to receive uponand equity.

The gross proceeds from the occurrenceexercise of such fundamental transaction if it had been, immediately prior to such fundamental transaction, the holdercommon stock warrants exercised were $5,961,001 during the nine months ended March 31, 2014, net of the $35,470 liability for the shares of common stock into which such holder's shares of Series D Convertible Preferred Stock is then convertible.were not issued until April 2014.

Gross proceeds from public offering $3,703,527 
Underwriting discount  (185,176)
Legal and accounting expense  (184,514)
Listing expense  (48,500)
Other expense  (6,045)
Net proceeds  3,279,292 

Warrant liability and related offering cost deferral

 

Based on the guidance contained in ASC 815 “Derivatives and Hedging”, management has concluded that the warrants issued in the October 13,and December 2011 underwritten registered offering of 2,500,000 shares of common stock should be classified as a derivative liability and has recorded a liability at fair value. The Company determined the fair value of the warrants using the Black-Scholes fair value model. The Company determined the fair value of the warrants on the date of the offering to be as disclosed in the tables below. The Company has recognized a change in fair value as described in the tabletables below:

 

Change in fair value of the derivative warrant liability for the three months ended DecemberMarch 31, 20132014 and 2012,2013, respectively.

 

  Three months ended  Three months ended 
  December 31, 2013  December 31, 2012 
Change in fair value $(117,000) $55,000 
  Three months ended  Three months ended 
  March 31, 2014  March 31, 2013 
Change in fair value of the derivative warrant liability $1,095,000  $(109,000)

 

Change in fair value of the derivative warrant liability for purchaser warrants and underwriter warrants contained in an equity transaction on October 19, 2011.

 

 Three months ended Three months ended  Three months ended
March 31, 2014
 Three months ended
March 31, 2013
 
 December 31, 2013  December 31, 2012  Quantity1 Amount Quantity1 Amount 
 Quantity1  Amount  Quantity1  Amount 
Balance, beginning of period  650,003  $127,000   650,003  $168,000 
Balance, beginning of the period  650,003  $20,000   650,003  $218,000 
Change in fair value  650,003   (107,000)  650,003   50,000   650,003   1,004,000       (99,000)
Warrants corrected  10,869   -   -   - 
Warrants exercised  -   -   -   -   (258,943)  (423,000)  -   - 
Balance, end of period  650,003  $20,000   650,003  $218,000 
Balance, end of the period  401,929  $601,000   650,003  $119,000 

 

Change in fair value of the derivative warrant liability for purchaser warrants and underwriter warrants contained in an equity transaction on December 7, 2011.

 

  Three months ended  Three months ended 
  December 31, 2013  December 31, 2012 
  Quantity1  Amount  Quantity1  Amount 
Balance, beginning of period  63,598  $13,000   63,598  $17,000 
Change in fair value  63,598   (10,000)  63,598   5,000 
Warrants exercised  -   -   -   - 
Balance, end of period  63,598  $3,000   63,598  $22,000 
Total fair value of warrant derivative liability at
December 31, 2013 and 2012
     $23,000      $240,000 

  Three months ended
March 31, 2014
  Three months ended
 March 31, 2013
 
  Quantity1  Amount  Quantity1  Amount 
Balance, beginning of the period  63,598  $3,000   63,598  $22,000 
Change in fair value  63,598   91,000   63,598   (10,000)
Warrants corrected  (400)  -   -   - 
Warrants exercised  (12,148)  (17,000)  -   - 
Balance, end of the period  51,050  $77,000   63,598  $12,000 
Total fair value of warrant derivative liability at March 31, 2014 and 2013     $678,000      $131,000 

Change in fair value of the derivative warrant liability for the sixnine months ended DecemberMarch 31, 20132014 and 2012,2013, respectively.

    

  Six months ended  Six months ended 
  December 31, 2013  December 31, 2012 
Change in fair value $(81,000) $(74,000)
  

Nine months ended
March 31, 2014

  

Nine months ended
March 31, 2013

 
Change in fair value $1,014,000  $(183,000)

 

Change in fair value of the derivative warrant liability for purchaser warrants and underwriter warrants contained in an equity transaction on October 19, 2011.

 

 Six months ended Six months ended  Nine months ended
March 31, 2014
 Nine months ended
March 31, 2013
 
 December 31, 2013  December 31, 2012  Quantity1 Amount Quantity1 Amount 
 Quantity1  Amount  Quantity1  Amount 
Balance, beginning of period  650,003  $94,000   650,003  $286,000 
Balance, beginning of the period  650,003  $94,000   650,003  $286,000 
Change in fair value  650,003   (74,000)  650,003   (68,000)  650,003   914,000   650,003   (167,000)
Warrants corrected  10,869   16,000         
Warrants exercised  -   -   -   -   (258,943)  (423,000)  -   - 
Balance, end of period  650,003  $20,000   650,003  $218,000 
Balance, end of the period  401,929  $601,000   650,003  $119,000 

 

Change in fair value of the derivative warrant liability for purchaser warrants and underwriter warrants contained in an equity transaction on December 7, 2011.

  

  Six months ended  Six months ended 
  December 31, 2013  December 31, 2012 
  Quantity1  Amount  Quantity1  Amount 
Balance, beginning of period  63,598  $10,000   63,598  $28,000 
Change in fair value  63,598   (7,000)  63,598   (6,000)
Warrants exercised  -   -   -   - 
Balance, end of period  63,598  $3,000   63,598  $22,000 
Total fair value of warrant derivative liability at
December 31, 2013 and 2012
     $23,000      $240,000 
  Nine months ended
March 31, 2014
  Nine months ended
March 31, 2013
 
  Quantity1  Amount  Quantity1  Amount 
Balance, beginning of the period  63,598  $10,000   63,598  $28,000 
Change in fair value  63,598   85,000   63,598   (16,000)
Warrants corrected  (400)  (1,000)        
Warrants exercised  (12,148)  (17,000)  -   - 
Balance, end of the period  51,050  $77,000   63,598  $12,000 
                 
Total fair value of warrant derivative liability at March 31, 2014 and 2013     $678,000      $131,000 

  

1 Quantity of warrants either issued or outstanding as of the date of valuation.

 

Warrants

 

The following table summarizes the warrants outstanding as of the beginning of the fiscal year, warrants exercised and warrants issued during the year and weighted average prices for each category.

  

     Weighted average 
  Warrants  exercise price 
Outstanding as of June 30, 2013  1,957,033  $1.38 
Warrants issued  5,648,738   0.72 
Outstanding as of December 31, 2013  7,605,771  $0.89 

  

 

Warrants

  Weighted average
exercise price
 
Outstanding as of June 30, 2013  1,957,033  $1.38 
Warrants issued  5,648,738   0.72 
Warrants corrected  10,869   0.94 
Warrants exercised  (6,969,829)  0.86 
Outstanding as of March 31, 2014  646,811  $1.14 

 

Warrants outstanding as of DecemberMarch 31, 20132014

 

Quantity  Expiration date Exercise price 
 6,000  June 8, 2015 $1.18 
 25,000  July 27, 2015  2.00 
 5,648,738  August 25, 2015  0.72 
 1,207,832  November 21, 2015  1.56 
 650,003  October 19, 2016  1.043 
 63,198  December 7, 2016  1.043 
 5,000  June 27, 2017  0.98 
 7,605,771    $0.89 
Quantity  Expiration date Exercise price 
 6,000  June 8, 2015  $1.18 
 25,000  July 27, 2015   2.00 
 157,832  November 21, 2015   1.56 
 401,929  October 19, 2016   0.944 
 51,050  December 7, 2016   0.944 
 5,000  June 27, 2017   0.98 
 646,811     $1.14 

 

10.Related Party Transaction

 

During the sixnine months ended DecemberMarch 31, 20132014 and 2012,2013, the Company continued to engage the services of APEX Data Systems, Inc., owned by Dwight Babcock, the Company’s Chairman and Chief Executive Officer, to modify and maintain the Company’s web interfaced data collection application to aggregate patient data in a controlled environment. The Audit Committee and Board of Directors approved the use of the ongoing services of APEX Data Systems. Mr. Babcock recused himself from the Board vote due to his conflict of interest. The cost recorded during the sixnine months ended DecemberMarch 31, 20132014 and 20122013 from APEX Data Systems, Inc. for the maintenance of the web interfaced data collection application was $9,720$12,720 and $8,960, respectively.$10,960. An additional $6,000$9,000 was spent on the implementation of Customer Relationship Management software in the sixnine months ended DecemberMarch 31, 2013.2014.

10

11.Subsequent Event

In January 2014, the holder of the 1,670 shares of Series D convertible preferred stock fully exercised its right to convert the 1,670 shares of Series D convertible preferred stock into 3,121,480 shares of common stock which resulted in an increase in shares of common stock outstanding from 38,419,502 to 41,540,982. Subsequent to the conversion, no shares of Series D convertible preferred stock remain outstanding.

 

ITEM 2 – MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

Caution Regarding Forward-Looking Information

 

In addition to historical information, this Form 10-Q contains certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (“PSLRA”). This statement is included for the express purpose of availing IsoRay, Inc. of the protections of the safe harbor provisions of the PSLRA.

 

All statements contained in this Form 10-Q, other than statements of historical facts, that address future activities, events or developments are forward-looking statements, including, but not limited to, statements containing the words "believe," "expect," "anticipate," "intends," "estimate," "forecast," "project," and similar expressions. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including any statements of the plans, strategies and objectives of management for future operations; any statements concerning proposed new products, services, developments or industry rankings; any statements regarding future economic conditions or performance; any statements of belief; and any statements of assumptions underlying any of the foregoing. These statements are based on certain assumptions and analyses made by us in light of our experience and our assessment of historical trends, current conditions and expected future developments as well as other factors we believe are appropriate under the circumstances. However, whether actual results will conform to the expectations and predictions of management is subject to a number of risks and uncertainties described under “Risk Factors” under Part II, Item 1A below and in the “Risk Factors” section of our Form 10-K for the fiscal year ended June 30, 2013 that may cause actual results to differ materially.

13

 

Consequently, all of the forward-looking statements made in this Form 10-Q are qualified by these cautionary statements and there can be no assurance that the actual results anticipated by management will be realized or, even if substantially realized, that they will have the expected consequences to or effects on our business operations. Readers are cautioned not to place undue reliance on such forward-looking statements as they speak only of the Company's views as of the date the statement was made. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

 

Critical Accounting Policies and Estimates

 

The discussion and analysis of the Company’s financial condition and results of operations are based upon its consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of these financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent liabilities. On an on-going basis, management evaluates past judgments and estimates, including those related to bad debts, inventories, accrued liabilities, and contingencies. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. The accounting policies and related risks described in the Company’s annual report on Form 10-K as filed with the Securities and Exchange Commission on September 30, 2013 are those that depend most heavily on these judgments and estimates. As of DecemberMarch 31, 2013,2014, there had been no material changes to any of the critical accounting policies contained therein.

 

11

Results of Operations

 

Three months ended DecemberMarch 31, 20132014 compared to three months ended DecemberMarch 31, 2012.2013.

 

Revenues.During the three months ended DecemberMarch 31, 2013,2014, total revenue increased from the three months ended December 31, 2012. Revenue generated by prostate brachytherapy and non-prostate related treatments which is described below as Product Sales – (Other) both increased. The increase in revenue from prostate brachytherapy treatments is the result of a new physician being added to a key physician group that resulted in nearly doubling of revenue at an existing treatment facility and the addition of a new treatment facility at which the new physician treated a significant volume of patients as well. While the overall revenue produced by Product Sales – (Other) continued to increase in the three months ended December 31, 2013decreased approximately nine (9%) percent when compared to the three months ended DecemberMarch 31, 2012, there continued to be significant variances2013. Revenue produced by prostate brachytherapy decreased in utilizationthe three months ended March 31, 2014 by approximately 6%. Prostate seed brachytherapy contributed 82% of the GliaSite® Radiation Therapy System (the “GliaSite RTS”) and in treating brain cancer and lung cancer with brachytherapy seeds. The newer brachytherapyoverall product sales reported as “other” represent more developmental applicationsduring the three months ended March 31, 2014 compared to 79% of ouroverall product which may not leadsales during the three months ended March 31, 2013. Management continues work with physicians to either a long-term revenue source or a significant product line and therefore revenue fluctuation in this segment is expected to be subject to more significant variation from quarter to quarter. Company management intends to actively pursue alternative uses forutilize the Company’s brachytherapy seedsFDA cleared products, sometimes in treatments consistenttandem with the FDA clearance granted permitting the Company to utilize other FDA cleared devices or application methods, as a meansto develop innovative methods to provide alternative treatments for cancers in various other body sites, which contributed the balance of administeringproduct sales, which were 18% of product sales during the treatments. New treatments such as those being initiated bythree months ended March 31, 2014 compared to 21% of product sales during the three months ended March 31, 2014. During the three months ended March 31, 2014, the Company can be expected to experience a staged entry to market in which primary adopters demonstrate the suitability of a treatment, after which wider adoption is possible. The products being implemented by the Company are very dependent on first adopters as a source of revenue which assists in offsetting some of the developmental cost,primarily treated five body sites including brain, gynecological, head and there is initially a significant change in revenue period over period that is expected to reach a plateau due to treatment capacityneck, lung and quantity of cases available to the first adopters until the mainstream adoption occurs, when and if there is favorable publication of the experiences and treatment outcomes of the first adopters. However, to date the Company has only experienced minimal sales to first adopters.prostate cancers. Management believes that the overall market for prostate brachytherapy has continued to receive increased pressure from other treatment options with higher reimbursement rates such as Intensity –Modulated Radiation Therapy (IMRT) and Robotics, buthowever, management believes that the treatment strategy of combining treatments incorporatingwhich incorporate brachytherapy with other modalities in the prostate, the addition of new treatment facilities and treatment of additional other body sites with brachytherapy havehas the potential to continue to increase revenue. During the three months ended December 31, 2013 and 2012, respectively, all product sales were generated by the brachytherapy seeds and the related methods of application except for the revenue generated by the sales of GliaSite RTS which include the sale of the Iotrex solution, catheter trays and access trays. The conversion of prospects to new GliaSite RTS customers has been a longer process than originally anticipated by the Company. The Company has experienced lengthy timelines in the internal processes of the medical facilities in reviewing and approving the use of the product at the request of their physician(s). These longer than anticipated internal processes are compounded by uncertain timelines and delays in receiving the approval for the requested modification of each facility's nuclear materials license, which is required to begin using GliaSite RTS and is dependent on external government regulators.

 

Key operating factors

12

 

Key operating factors            
  Three months  Three months       
Description ended 12-31-13  ended 12-31-12  Variance ($)  Variance (%) 
Product Sales (Prostate) $937,296  $840,819  $96,477   11%
Product Sales (Other)  148,112   134,638   13,474   10%
Total product sales $1,085,408  $975,457  $109,951   11%
Description 

Three months
ended 3-31-14

  Three months
ended 3-31-13
  Variance ($)  Variance (%) 
Product Sales $1,134,319  $1,251,478  $(117,159)  (9)%

Cost of product sales.

Cost of product sales nominally decreasedincreased during the three months ended DecemberMarch 31, 20132014 compared to the three months ended DecemberMarch 31, 2012.

2013. The two key operating factors that changed significantly in the three months ended DecemberMarch 31, 20132014 as compared to the three months ended DecemberMarch 31, 20122013 were the additionincrease in materials expense related to seed production which was primarily created by the price increase in isotope received from Russia in combination with one additional shipment of isotope during the medical device taxthree months ended March 31, 2014 when compared to the three months ended March 31, 2013 and an increasea decrease in production costs of the GliaSite RTS. The addition of the medical device tax expense®Radiation Therapy System (the “GliaSite RTS”) which was primarily the result of the implementationimproved timing of the Affordable Care Act in calendar year 2013. The increase in the GliaSite RTS production costs was the resultcases which allowed for a greater volume of additional Iotrex solution requiredproduced to meet the increased revenue. Additionally, there was a reductionbe utilized in overall pre-loading costs through a reduction in third-party loading cost, as the Company is loading nearly 100% of its orders in-house, and an improved utilization of pre-loading materials. There was a reduction in other expense as the result of six months property tax expense being recordedtreating patients during the three months ended DecemberMarch 31, 2012 while there was three months2014 and the non-recurrence of an expense recordedrelated to expired catheters which occurred during the three months ended DecemberMarch 31, 2013. Nominal cost changes which occurred in other categories of seed production expenses are summarized as Other cost of product sales (Seeds). which as a group were insignificant.

 

Key operating factors

 

 Three months Three months     
Description ended 12-31-13 ended 12-31-12 Variance ($) Variance (%)  Three months
ended 3-31-14
 Three months
 ended 3-31-13
 Variance ($) Variance (%) 
Medical device tax expense $23,612 $- $23,612 100%
Pre-loading production expense 64,147 80,033 (15,886) (20%)
Other expense 17,784 32,547 (14,763) (45%)
Materials expense $421,122  $356,126  $64,996   18%
Other cost of product sales (Seeds) 975,589 998,477 (22,888) (2%)  637,150   663,723   (26,573)  (4)%
GliaSite RTS  38,182  23,026  15,156  66%  25,141   45,725   (20,584)  (45)%
Total cost of product sales $1,119,314 $1,134,083 $(14,769) (1%) $1,083,413  $1,065,574  $17,839   2%

 

Gross loss.profit.  Gross lossprofit for the three months ended DecemberMarch 31, 20132014 decreased compared to the three month period ended DecemberMarch 31, 20122013 as a result of increaseddecreased revenue from product sales which was further reduced by a minimalnominal increase in total cost of product sales. Management continued to seek to control variable costs, however, at this time most remaining production costs are of a fixed nature and related to minimum personnel costs required to meetsatisfy peak demand orders.orders, however, during the three months ended March 31, 2014, there was an additional increase in the cost of some materials that could not be controlled as the result of limited sources for these materials.

 

Key operating factor

 

  Three months  Three months       
Description ended 12-31-13  ended 12-31-12  Variance ($)  Variance (%) 
Gross loss $(33,906) $(158,626) $124,720   79%
                 
Gross loss percentage  (3%)  (16%)        
Description Three months
ended 3-31-14
  Three months
 ended 3-31-13
  Variance ($)  Variance (%) 
Gross profit $50,906  $185,904  $(134,998)  (73)%
                 
Gross profit percentage  4%  15%        

 

Research and development.Research and development costs increased duringdecreased by a nominal amount for the three months ended DecemberMarch 31, 20132014 compared to the three months ended DecemberMarch 31, 2012. The2013. No single category whichcost factor changed materially was protocol expense assignificantly during the Company continuesthree months ended March 31, 2014 when compared to invest in aggregating data regarding the performance of the Company products which was offset by a combination of immaterial changes in other cost categories.three months ended March 31, 2013.

15

 

Key operating factors

    

 Three months Three months     
Description ended 12-31-13 ended 12-31-12 Variance ($) Variance (%)  

Three months
ended 3-31-14

 

Three months
ended 3-31-13

 Variance ($) Variance (%) 
Protocol expense $53,792 $24,333 $29,459 121%
Other research-development expense  116,238  124,843  (8,605)  (7%)
Total research and development $170,030 $149,176 $20,854 14% $153,611  $155,137  $(1,526)  (1)%

 

Sales and marketing expenses.Sales and marketing expenses were virtually flatdecreased in the three months ended DecemberMarch 31, 20132014 compared to the three months ended DecemberMarch 31, 2012.2013. The single category which changed materiallysignificantly was travel expense as the Company continues to manage its travel costs as actively as possible which was offset by a combination of nominal changes in other cost categories.possible.

 

Key operating factors

    

 Three months Three months     
Description ended 12-31-13  ended 12-31-12  Variance ($)  Variance (%)  Three months
ended 3-31-14
 Three months
ended 3-31-13
 Variance ($) Variance (%) 
Travel expense $46,006  $69,794  $(23,788)  (34%) $46,430  $69,470  $(23,040)  (33)%
Other sales-marketing expense  280,461   252,300   28,161   11%  199,128   221,342   (22,214)  (10)%
Total sales and marketing $326,467  $322,094  $4,373   1% $245,558  $290,812  $(45,254)  (16)%

 

General and administrative expenses. General and administrative expenses increased in the three months ended DecemberMarch 31, 20132014 compared to the three months ended DecemberMarch 31, 2012.2013.TheA single expense category, which changed materially was bad debt expense (recovery), which is an estimate made based on established criteria by management of the unpaid invoices in accounts receivable which may not be paid by the customer, increased materially. This management estimate fluctuates significantly based on timeliness of payments received from our customers. The balance of the increased cost was partially offset byfrom a combination of nominal changes in other cost categories.As of December 31, 2012, there was a significant reduction in the amounts classified by management for inclusion in the allowance for doubtful accounts when compared to the balancecategories which are summarized as of September 30, 2012. This decrease in allowance for doubtful accounts resulted in an unusually large recovery being recognized in the statement of operations during the three months ended December 31, 2012. The amount included in allowance for doubtful accounts at September 30, 2012 was approximately double the next largest balance in allowance for doubtful accounts during the past eight quarters. The reduction in allowance for doubtful accounts during the three months ended December 31, 2012 was the result of the successful collection of amounts due to the Company from its customers.general and administrative (Other).

 

Key operating factors

 

 Three months Three months     
Description ended 12-31-13  ended 12-31-12  Variance ($)  Variance (%)  Three months
ended 3-31-14
 Three months
ended 3-31-13
 Variance ($) Variance (%) 
Bad debt expense (recovery)  (15,082)  (64,949)  49,867   77% $38,861  $(18,697)  57,558   308%
General and administrative (Other)  529,046   534,508   (5,462)  (1%)  601,871   582,772   19,099   3%
Total general and administrative $513,964  $469,559  $44,405   9% $640,732  $564,075  $76,657   14%

 

Operating loss. Operating loss for the three months ended DecemberMarch 31, 2013 decreased2014 increased compared to the three months ended DecemberMarch 31, 20122013 primarily as the result of the increasedecrease in product sales coupled with the non-material decreasemarginal increase in cost of product sales and the non-materialnominal increase in operating expenses.

 

Key operating factor

 

  Three months  Three months       
Description ended 12-31-13  ended 12-31-12  Variance ($)  Variance (%) 
Operating loss $(1,044,367) $(1,099,455) $55,088   5%

Description Three months
ended 3-31-14
  Three months
ended 3-31-13
  Variance ($)  Variance (%) 
Operating loss $(988,995) $(824,120) $164,875   20%

Change in fair value of warrant derivative liability. During the three months ended December 31, 2011, there was a warrant derivative liability established upon issuance of warrants during October 2011 to December 2011 to the purchasers and underwriters in the Company’s registered offering. The warrant derivative liability requires periodic evaluation for changes in fair value. As required at DecemberMarch 31, 2014 and March 31, 2013, the Company evaluated the fair value of the warrant derivative liability using the Black-Scholes option pricing model and applied updated inputs as of those dates. The resulting change in fair value was recorded as of DecemberMarch 31, 2014 and March 31, 2013. The change in valuation of the warrant derivative liability as calculated using the Black-Scholes option pricing model is not reflective of Company operations which is why these changes are included in the consolidated statement of operations in the non-operating income/(expense) section and an adjusting item to reconcile net loss to net cash used by operating activities in the consolidated statement of cash flows.

The increase in the warrant derivative liability resulted from the significant increase in the value of the Company’s common stock in March 2014. The Black-Scholes option pricing model utilizes multiple inputs over which management exerts little control. The model uses stock price (market driven), exercise price (contractual), expected life of the contractual life (estimate made by management when the warrant derivative liability is established and reduced by the life expended), volatility of the Company stock (market driven) and a risk-free rate.

 

Key operating factor

   

 Three months Three months     
Description ended 12-31-13  ended 12-31-12  Variance ($)  Variance (%)  Three months
ended 3-31-14
 Three months
ended 3-31-13
 Variance ($) Variance (%) 
Change in fair value of warrant liability $117,000 $(55,000) $172,000   (313%)
Change in fair value of warrant derivative liability $(1,095,000) $109,000  $(1,204,000)  (1,105)%

 

SixNine months ended DecemberMarch 31, 20132014 compared to sixnine months ended DecemberMarch 31, 2012.2013.

 

Revenues. Revenue generatedDuring the nine months ended March 31, 2014, total revenue, and revenue produced by prostate brachytherapy experienced a nominal increase while the industry continuedand brachytherapy utilized to experience a decrease as a whole. The increase in revenue created was the result of a single physician increasing his volume of treatments by a factor of 2.5 times the prior year whileprovide brachytherapy treatment alternatives for other physician changes offset each other. The strategy implemented by management in prior years of diversifying the number of body sites being actively treated with the Proxcelan Cs-131 brachytherapy seed has increased revenue during the six months ended December 31, 2013non-prostate applications, were unchanged when compared to the sixnine months ended DecemberMarch 31, 2012. Company management intends2013. Revenue produced by prostate brachytherapy was unchanged in the nine months ended March 31, 2014 when compared to continuethe nine months ended March 31, 2013. Prostate seed brachytherapy contributed 83% of the overall product sales during the nine months ended March 31, 2013 and 2014, respectively. Management continues to actively pursue alternative uses forwork with physicians to utilize the Company’s brachytherapy seedsFDA cleared products, sometimes in treatments consistenttandem with the FDA clearance granted permitting the Company to utilize other FDA cleared devices or application methods as a meansto develop innovative methods, to provide treatment alternatives for cancers in various other body sites, which contributed the balance of administeringproduct sales of 17% during the treatments as previously identifiednine months ended March 31, 2014 and to continue to search out new applications in coordination with physicians.

2013, respectively. During the nine months ended March 31, 2014, the Company primarily treated five body sites including brain, gynecological, head and neck, lung and prostate cancers. Management believes that the overall market for prostate brachytherapy has continued to receive increased pressure from other treatment options with higher reimbursement rates such as IMRTIntensity – Modulated Radiation Therapy (IMRT) and Robotics, buthowever, management believes that combinationthe treatment strategy of combining treatments incorporatingwhich incorporate brachytherapy with other modalities in the prostate, the addition of new treatment facilities and treatment of additional other body sites with brachytherapy havehas the potential to continue to increase.increase revenue.

 

  Six months  Six months       
Description ended 12-31-13  ended 12-31-12  Variance ($)  Variance (%) 
Product Sales (Prostate) $1,790,049  $1,722,675  $67,374   4%
Product Sales (Other)  345,274   309,014   36,260   12%
Total product sales $2,135,323  $2,031,689  $103,634   5%

Key operating factors

Description Nine months
ended 3-31-14
  Nine months
ended 3-31-13
  Variance ($)  Variance (%) 
Product Sales $3,269,642  $3,283,167  $(13,525)  0%

1517
 

 

Cost of product sales. Cost of product sales related to brachytherapy seed sales decreasedincreased by a nominal amount during the sixnine months ended DecemberMarch 31, 20132014 compared to the sixnine months ended DecemberMarch 31, 20122013 as the result of a combination of individually nominal cost reductions which are described as other cost of product sales (Seeds), partially offset byfactors including increases in materials expense and the addition of the medical device tax incurred as part of the Affordable Care Act.Act beginning in the calendar year 2013 which only impacted three of the nine months ended March 31, 2013 compared to all nine of the months for the nine months ended March 31, 2014. These increases were partially reduced by decreases in depreciation and amortization expense as assets continue to reach the end of their depreciable lives without being replaced and a net reduction in preload expense as the result of a reduced utilization of third party loaders which was partially offset by increased internal costs to accommodate the increased volume of work. Cost of product sales related to GliaSite RTS increased as the result of increased Iotrex production required to support the increased sales of the product all of which was not able to be fully utilized due to the timing of cases along with the addition of theadditional medical device tax incurred as part of the Affordable Care Act. The net resultimpact of the reduced cost of product sales related to brachytherapy seeds was offset by an increased cost of product sales related to GliaSite RTS, whichchanges resulted in the overalla nominal increase in cost of product sales.

 

Key operating factors

 

 Six months Six months     
Description ended 12-31-13 ended 12-31-12 Variance ($) Variance (%)  Nine months
ended 3-31-14
 Nine months
ended 3-31-13
 Variance ($) Variance (%) 
Medical device tax $46,404 $- $46,404 100% $71,378  $27,553  $43,825   159%
Materials expense  1,316,564   1,247,592   68,972   6%
Depreciation and amortization expense  505,829   548,241   (42,412)  (8)%
Pre-loading expense  219,277   236,616   (17,339)  (7)%
GliaSite RTS 81,071 38,266 42,805 112%  106,212   83,991   22,221   26%
Other cost of product sales (Seeds)  2,119,062  2,172,474  (53,412)  (2%)  1,110,690   1,132,321   (21,631)  (2)%
Total cost of product sales $2,246,537 $2,210,740 $35,797 2% $3,329,950  $3,276,314  $53,636   2%

 

Gross loss.profit / (loss).  Gross lossprofit / (loss) for the sixnine month period ended DecemberMarch 31, 20132014 decreased compared to the sixnine month period ended DecemberMarch 31, 20122013 primarily as a result of the increaseddecreased product sales reduced by thecombined with a nominal increase in cost of product sales.

 

Key operating factor

 

  Six months  Six months       
Description ended 12-31-13  ended 12-31-12  Variance ($)  Variance (%) 
Gross loss $(111,214) $(179,051) $67,837   38%
                 
Gross loss percentage  (5%)  (9%)        
Description Nine months
ended 3-31-14
  Nine months
ended 3-31-13
  Variance ($)  Variance (%) 
Gross profit / (loss) $(60,308) $6,853  $(67,161)  (980)%
                 
Gross profit / (loss) percentage  (2)%  0%        

 

Research and development. Research and development costs increased by a nominal amount induring the sixnine months ended DecemberMarch 31, 20132014 compared to the sixnine months ended DecemberMarch 31, 20122013 primarily as a result of changesa change in the key operating factors that net to an overall nominal increase in cost.The single operating factor that increased in research and development expense which was the continued investment in protocol expenses.

 

Key operating factors

  

 Six months Six months      
Description ended 12-31-13  ended 12-31-12  Variance ($)  Variance (%)  Nine months
ended 3-31-14
 Nine months
ended 3-31-13
 Variance ($) Variance (%) 
Protocol expense $87,613  $41,191  $46,422   113% $130,322  $67,025  $63,297   94%
Research and development (Other)  229,407   249,457   (20,050)  (8%)  340,309   378,760   (38,451)  (10)%
Total research and development $317,020  $290,648  $26,372   9%

 

 $470,631  $445,785  $24,846   6%

 

18

Sales and marketing expenses.Sales and marketingexpenses increased inwere virtually unchanged during the sixnine months ended DecemberMarch 31, 20132014 compared to the sixnine months ended DecemberMarch 31, 2012.2013. Travel expense was reduced as the result of a function of reduceddecrease in meal expenses beingand automobile expense incurred during the sixnine months ended DecemberMarch 31, 20132014 when compared to the sixnine months ended DecemberMarch 31, 2012.2013. The overall decrease in travel expense and in particular meals expense is the result of a revision of the travel policy governing reimbursement for these expenses. Payroll, benefits and share-based compensation increased as a function of having an increasedexpenses combined with the reduction in automobile travel expense is impacted by both the number of sales employeesmanagers in the field. Tradeshowsfield and convention expense increased primarily as the resultmethod by which they are reimbursed for the use of increased attendance at society meetings, conventions and tradeshows.their vehicles.

16

 

Key operating factors

 Six months Six months      
Description ended 12-31-13  ended 12-31-12  Variance ($)  Variance (%)  Nine months
ended 3-31-14
 Nine months
ended 3-31-13
 Variance ($) Variance (%) 
Travel expense $113,627  $135,489  $(21,862)  (16%) $160,057  $201,010  $(40,953)  (20)%
Payroll, benefits and share-based                
compensation  452,137   406,921   45,216   11%
Sales and marketing (Other)  119,888   95,740   24,148   25%  771,153   727,952   43,201   6%
Total sales and marketing $685,652  $638,150  $47,502   7% $931,210  $928,962  $2,248   0%

 

General and administrative expenses.General and administrative expenses increased in the sixnine months ended DecemberMarch 31, 20132014 compared to the sixnine months ended DecemberMarch 31, 20122013 primarily as a result of onethree operating factors. The three key operating factor. The single key operating factor wasfactors that increased were bad debt expense/(recovery), legal expense and public company expenseexpense. Bad debt expense/(recovery) increased as the result of the aging of specific customer accounts that in the judgment of management required creating an allowance for their potential collectability, legal expenses increased as the result of increased SEC filing expenses in combination withfilings, compliance review, contract revisions and general corporate legal services while public company expense increased investor relationsdue to increased SEC filing expenses.

 

Key operating factors

 

 Six months Six months      
Description ended 12-31-13  ended 12-31-12  Variance ($)  Variance (%)  Nine months
ended 3-31-14
 Nine months
ended 3-31-13
 Variance ($) Variance (%) 
Bad debt expense/(recovery) $18,879  $(32,174) $51,053   159%
Legal expense  150,475   102,381   48,094   47%
Public company expense $140,854  $117,340  $23,514   20%  230,495   206,565   23,930   12%
General and administrative (Other)  1,024,146   997,072   27,074   3%  1,405,883   1,401,715   4,168   0%
Total general and administrative $1,165,000  $1,114,412  $50,588   5% $1,805,732  $1,678,487  $127,245   8%

 

Operating loss. Operating loss for the sixnine months ended DecemberMarch 31, 20132014 increased compared to the sixnine months ended DecemberMarch 31, 20122013 primarily as a result of a decrease in revenue from product sales and an overall increase in operating expenses andboth cost of product sales in excess of the increase in revenue from product sales.and operating expenses.

 

Key operating factor

   

  Six months  Six months       
Description ended 12-31-13  ended 12-31-12  Variance ($)  Variance (%) 
Operating loss $(2,278,886) $(2,222,261) $(56,625)  (3%)

Description Nine months
ended 3-31-14
  Nine months
ended 3-31-13
  Variance ($)  Variance (%) 
Operating loss $(3,267,881) $(3,046,381) $221,500   7%

Change in fair value of warrant derivative liability. During the three months ended December 31, 2011, there were warrant derivative liabilities established upon issuance of warrants to the purchasers and underwriters in the Company’s registered offering during October 2011 to December 2011. Per ASC 820, the warrant derivative liability requires periodic evaluation for changes in fair value. As required at DecemberMarch 31, 20132014 and DecemberMarch 31, 2012,2013, the Company evaluated the fair value of the warrant derivative liability using the Black-Scholes option pricing model on which the original warrant derivative liability was based and applied updated inputs as of those dates. The resulting change in fair value was recorded as of DecemberMarch 31, 20132014 and DecemberMarch 31, 2012.2013. The change in valuation of the warrant derivative liability is calculated using the Black-Scholes option pricing model and not reflective of Company an operations which is why these changes are included in the consolidated statement of operations in the non-operating income/(expense) section and as an adjusting item to reconcile net loss to net cash used by operating activities in the consolidated statement of cash flows.

 

  Six months  Six months       
Description ended 12-31-13  ended 12-31-12  Variance ($)  Variance (%) 
Change in fair value of warrant liability $81,000  $74,000  $7,000   9%

The increase in the warrant derivative liability resulted from the significant increase in the value of the Company’s common stock in March 2014. The Black-Scholes option pricing model utilizes multiple inputs over which management exerts little control. The model uses stock price (market driven), exercise price (contractual), expected life of the contractual life (estimate made by management when the warrant derivative liability is established and reduced by the life expended), volatility of the Company stock (market driven) and a risk-free rate.

Key operating factor

Description Nine months
ended 3-31-14
  Nine months
ended 3-31-13
  Variance ($)  Variance (%) 
Change in fair value of  warrant derivative liability $(1,014,000) $183,000  $(1,197,000)  (654)%

 

Liquidity and capital resources. The Company has historically financed its operations through cash investments from shareholders. During the sixnine months ended DecemberMarch 31, 20132014 and DecemberMarch 31, 2012,2013, the Company primarily used existing cash reserves to fund its operations and capital expenditures.

 

Cash flows from operating activities

 

Cash used by operating activities is the net loss adjusted for non-cash items and changes in operating assets and liabilities. Management has continued to reduce cash consumed in operating activities through a combination of cost reductions and operational efficiencies identified in the results of operations that resulted in an increase in the net loss, which when reduced by the non-cash items and non-cash changes in operating assets and liabilities, resulted in an overall increase in netcontrol cash used in operations which has increased by operating activities fora nominal amount during the sixnine months ended DecemberMarch 31, 20132014 when compared to the sixnine months ended DecemberMarch 31, 2012.2013.

 

Key operating factor

   

  Six months  Six months       
Description ended 12-31-13  ended 12-31-12  Variance ($)  Variance (%) 
Net loss $(2,197,878) $(2,147,995) $(49,883)  (2%)
Non-cash items  351,632   405,718   (54,086)  (13%)
Non-cash changes in operating assets and liabilities  108,244   229,281   (121,037)  (53%)
Net cash used by operating activities $(1,738,002) $(1,512,996) $(225,006)  (15%)

Description Nine months
ended 3-31-14
  Nine months
ended 3-31-13
  Variance ($)  Variance (%) 
Net loss $(4,281,317) $(2,863,032) $(1,418,285)  (50)%
Non-cash items  1,693,709   505,464   1,188,245   235%
Non-cash changes in operating  assets and liabilities  348,411   87,622   260,789   298%
Net cash used by operating activities $(2,239,197) $(2,269,946) $30,749   1%

Cash flows from investing activities

 

Cash used by investing activities during the sixnine months ended DecemberMarch 31, 20132014 was primarily related to the deployment of new equipment to improve the efficiency of operations and in the sixnine months ended DecemberMarch 31, 20122013 was primarily related to the capitalization of costs related to other assets. The amounts recorded to restricted cash in both periods are the accrual of interest earned on certificates of deposit with two financial institutions that are a requirement of the Washington State Department of Health.

 

Key operating factor

    

 Six months Six months     
Description ended 12-31-13  ended 12-31-12  Variance ($)  Variance (%)  Nine months
ended 3-31-14
 Nine months
ended 3-31-13
 Variance ($) Variance (%) 
Purchases of fixed assets $(14,419) $-  $(14,419)  100% $(16,333) $-  $(16,333)  100%
Additions to licenses and other assets  (1,562)  (13,407)  11,845   (88%)  (5,168)  (12,926)  7,758   (60)%
Change in restricted cash  (32)  (84)  52   (62%)  (45)  (104)  59   (57)%
Net cash used by investing activities $(16,013) $(13,491) $(2,522)  19% $(21,546) $(13,030) $(8,516)  65%

Cash flows from financing activities

 

Cash provided by financing activities in the sixnine months ended DecemberMarch 31, 20132014 and DecemberMarch 31, 20122013 was the result of the sales of common stock and Series D Convertible Preferred Stock through registered direct and underwritten offerings.offerings, common stock warrant exercises and non-qualified stock option exercises by former employees. Cash used during the sixnine months ended DecemberMarch 31, 20132014 and 20122013 was the result of dividend payments to the Series B preferred shareholders.

 

Key operating factor

 

  Six months  Six months       
Description ended 12-31-13  ended 12-31-12  Variance ($)  Variance (%) 
Preferred dividend payments $(10,632) $(10,632) $-   0%
Proceeds from sale of preferred stock, net  1,478,712   -   1,478,712   100%
Proceeds from sale of common stock  1,800,580   3,305,111   (1,504,531)  (46%)
Net cash provided by financing activities $3,268,660  $3,294,479  $(25,819)  (1%)

Description Nine months
ended 3-31-14
  Nine months
ended 3-31-13
  Variance ($)  Variance (%) 
Preferred dividend payments $(10,632) $(10,632) $-   0%
Proceeds from exercise of employee  stock options  15,129   11,309   3,820   34%
Proceeds from exercise of common  stock warrants  5,961,001   1,825   5,959,176   326,530%
Proceeds from sale of preferred stock, pursuant to underwritten offering, net  1,478,703   -   1,478,703   100%
Proceeds from sale of common stock, pursuant to underwritten offering, net  1,800,589   -   1,800,589   100%
Proceeds from sale of common stock, net  13,818,927   3,291,977   10,526,950   320%
Net cash provided by  financing activities $23,063,717  $3,294,479  $19,769,238   600%

 

Projected Fiscal Year 2014 Liquidity and Capital Resources

 

At DecemberMarch 31, 2013,2014, the Company held cash and cash equivalents of $4,414,572$23,702,901 as compared to $2,899,927 of cash and cash equivalents at June 30, 2013.

 

The Company had approximately $4.31$23.62 million of cash and cash equivalents, which are fully insured by the Federal Depository Insurance Company (FDIC), and no short-term investments as of February 6,April 30, 2014. The Company’s monthly required cash operating expenditures were approximately $290,000$249,000 in the sixnine months ended DecemberMarch 31, 2013,2014, which represents a 15% increase1% decrease or approximately $38,000$3,000 from average monthly cash operating expenditures of $252,000 in the sixnine months ended DecemberMarch 31, 2012.2013. The increased use of cash in operating activities of approximately $225,000$31,000 is primarily the result of the increased net loss of approximately $50,000$1,418,285 which was driven primarily by the increasesnon-cash increased change in costchange in fair value of product saleswarrant derivative liability of $1,197,000 and operating expenses in excess of thean increase in revenue, a decrease of $54,000 of cash contributed by changes in non-cash expenses and a decrease of approximately $121,000 of cash contributed by$261,000 in non-cash changes in operating assets and liabilities. Management believes that there will not be a significant requirement for capital equipment with the exception of the production of liquid cesium-131 for use in the GliaSite RTS which is expected to be less than $50,000, however, there is no assurance that unanticipated needs for capital equipment may not arise for other needs.

Management intends to continue its existing protocol studies and to begin new protocol studies on lung and inter-cranial cancer treatments using Cesium-131 brachytherapy seeds and the GliaSite RTS. The Company continues to believe that approximately $180,000 in expense will be incurred during fiscal year 2014 related to protocol expenses relating to lung cancer, intra-cranial cancer and both dual therapy and mono therapy prostate cancer protocols but there is no assurance that unanticipated needs for additional protocols in support of the development of new applications of our existing products may not arise.

 

Based on the foregoing assumptions, management believes cash, cash equivalents, and short-term investments of approximately $4.31$23.62 million on hand at February 6,April 30, 2014 will be sufficient to meet our anticipated cash requirements for operations and capital expenditure requirements through at least the next twelve monthsfor several years assuming both revenue and expenses remain at current levels.

 

Management plans to attain breakeven and generate additional cash flows by increasing revenues from both new and existing customers (through our direct sales channels and through our distributors), increasing sales of the Company’s GliaSite RTS, and expanding into other market applications which initially will include inter-cranial, head and neck, and lung implants, while maintaining the Company's focus on cost control. However, there can be no assurance that the Company will attain profitability or that the Company will be able to attain increases in its revenue. Sales in the prostate market have not shown the increases necessary to breakeven during the past sixnine fiscal years and showed only a nominal increaseno change during the sixnine months ended DecemberMarch 31, 2013.2014.

 

For the sixnine months ended DecemberMarch 31, 2013,2014, revenue from other treatment modalities with brachytherapy seeds has decreased by 16%20% when compared to the sixnine months ended DecemberMarch 31, 2012.2013. When including the revenue from the sale of GliaSite RTS, revenue from non-prostate treatments has increased 12%decreased 4% in the sixnine months ended DecemberMarch 31, 20132014 compared to the sixnine months ended DecemberMarch 31, 2012.2013. As management is focused on increasing revenue from head and neck, colorectal, lung and brain applications of Cesium-131 brachytherapy seeds in addition to increasing the number of cases treated with of the GliaSite RTS, management believes the Company has sufficient cash and cash equivalents to sustain protocols, marketing staff, production staff and production equipment as it works to gain market share.

 

These non-prostate brachytherapy treatments are in the early stages of application in the clinical setting and the purchasing patterns are subject to the influence of a few key physicians which can significantly influence revenue from quarter to quarter.quarter and year to year.

 

There was no material change in the use of proceeds from our public offerings as described in our final prospectus supplements filed with the SEC pursuant to Rule 424(b) on July 17, 2012, and August 29, 2013.2013 and March 24, 2014. Through DecemberMarch 31, 2013,2014, the Company had used the net proceeds raised through the July 2012, and August 2013 and March 2014 offerings as described in the table below and held the remaining net proceeds in cash and cash equivalents. No offering expenses were paid directly or indirectly to any of our directors or officers (or their associates) or persons owning ten percent or more of any class of our equity securities or to any other affiliates.

 

Offering description Period Net proceeds  Remaining net proceeds  Period Net proceeds Remaining net proceeds 
Registered direct offering July 2012 $3,291,977  $1,133,455  July 2012 $3,291,977 $643,681 
Underwritten offering August 2013  3,279,292   3,279,292  August 2013 3,279,292 3,279,292 
Registered direct offering March 2014  13,818,927  13,818,927 
Total    6,571,269   4,412,747    $20,390,196 $17,741,900 

 

Management believes thatWhile management does not believe it needs to raise additional capital to meet its goals and objectives for the Company will requireforeseeable future, if it does need to raise additional equity investment to maintain its common stock’s listing status oncapital as the NYSE MKT. Theresult of presently unanticipated opportunities or strategic acquisitions, the Company expects to finance its future cash needs through the conversion of outstanding warrants to purchase common stock, other sales of equity, possible strategic collaborations, debt financing or through other sources that may be dilutive to existing shareholders. Management anticipates that if it raises additional financing that it will be at a discount to the market price and it will be dilutive to shareholders. Of course, funding may not be available to it on acceptable terms, or at all. If the Company is unable to raise additional funds, it may be unable to expand into new applications and may need to curtail operations.

Other Commitments and Contingencies

 

The Company is subject to various local, state, and federal environmental regulations and laws due to the isotopes used to produce the Company’s product. As part of normal operations, amounts are expended to ensure that the Company is in compliance with these laws and regulations. While there have been no reportable incidents or compliance issues, the Company believes that if it relocates its current production facilities then certain decommissioning expenses will be incurred. An asset retirement obligation was established in the first quarter of fiscal year 2008 for the Company’s obligations at its current production facility. This asset retirement obligation will be for obligations to remove any residual radioactive materials and to remove all leasehold improvements.

 

The industry that the Company operates in is subject to product liability litigation. Through its production and quality assurance procedures, the Company works to mitigate the risk of any lawsuits concerning its products.product. The Company also carries product liability insurance to help protect it from this risk.

 

The Company has no off-balance sheet arrangements.

 

ITEM 3 – QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

As a smaller reporting company, the Company is not required to provide Part I, Item 3 disclosure in this Quarterly Report.

 

ITEM 4 – CONTROLS AND PROCEDURES

 

Evaluation of Disclosure Controls and Procedures

 

Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, we conducted an evaluation of the design and operation of our disclosure controls and procedures, as such term is defined under Rules 13a-14(c) and 15d-14(c) promulgated under the Securities Exchange Act of 1934, as amended (the "Exchange Act"), as of DecemberMarch 31, 2013.2014. Based on that evaluation, our principal executive officer and our principal financial officer concluded that the design and operation of our disclosure controls and procedures were effective. The design of any system of controls is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions, regardless of how remote. However, management believes that our system of disclosure controls and procedures is designed to provide a reasonable level of assurance that the objectives of the system will be met.

 

Changes in Internal Control over Financial Reporting

 

There have not been any changes in our internal control over financial reporting (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) during the most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

The Company is continuing the process of remediating the single deficiency which constituted a material weakness identified in its Form 10-K for the fiscal year ended June 30, 2013.

Progress made on remediating the single deficiency which constituted a material weakness in the sixnine months ended DecemberMarch 31, 20132014 consisted of the following:

 

·The Company promoted its Controller, Principal Financial and Accounting Officer, to the position of Chief Financial Officer effective October 1, 2013.

 

As a result of ongoing reviews of all significant and non-routine transactions, management believes that there are no material inaccuracies or omissions of material fact and to the best of its knowledge believes that the consolidated financial statements for the three and sixnine months ended DecemberMarch 31, 20132014 fairly present in all material respects the financial condition and results of operations for the Company in conformity with U.S generally accepted accounting principles.

 

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PART II - OTHER INFORMATION

 

ITEM 1A – RISK FACTORS

 

There have been no material changes forto the risk factors disclosed in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended June 30, 2013, except for the following:2013.

Outstanding Warrants May Depress Share Price. Our warrants issued in August 2013 to purchase 5,648,738 shares of our common stock with an exercise price of $0.72 per share (subject to possible reduction to $0.535 per share if Company shareholder approval is obtained at the upcoming annual meeting to be held on March 5, 2014) become exercisable March 1, 2014 and do not expire until August 29, 2015. Until these warrants are fully exercised or expire, it may depress the price of our common stock to the warrants' exercise price.

Failure to Comply with NYSE MKT Listing Standards And Any Resulting Delisting Could Adversely Affect The Market For Our Common Stock. Our common stock is presently listed on the NYSE MKT. The NYSE MKT will consider delisting a company's securities if, among other things, the company fails to maintain minimum stockholder's equity or the company has sustained losses which are so substantial in relation to its overall operations or its existing financial resources, or its financial condition has become so impaired that it appears questionable, in the opinion of the NYSE MKT, as to whether such issuer will be able to continue operations and/or meet its obligations as they mature. There can be no assurance that we will be able to maintain our listing on the NYSE MKT indefinitely. We anticipate falling below the minimum stockholders equity requirement for the quarter ended March 31, 2014. We may need to raise additional capital sooner than anticipated to meet listing standards if the warrants sold in August 2013 are not exercised. If we are unable to raise this capital our shares may become delisted. In the event that our common stock is delisted from the NYSE MKT, trading, if any, in the common stock would be conducted in the over-the-counter market. As a result, our shareholders would likely find it more difficult to dispose of, or to obtain accurate quotations as to the market value of, our common stock.

 

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

Use of Proceeds from Registered Securities

 

On October 27, 2009, we filed a registration statement on Form S-3 to register securities up to $15 million in value for future issuance in our capital raising activities. The registration statement became effective on November 13, 2009, and the Commission file number assigned to the registration statement is 333-162694. An additional $585,559 was added to this registration statement through a Form S-3 MEF filed on July 16, 2012. The registration statement expired on November 12, 2012.

 

There was no material change in the use of proceeds from the July 17, 2012 registered publicdirect offering as described in our final prospectus filed with the SEC pursuant to Rule 424(b) on July 17, 2012. Through DecemberMarch 31, 2013,2014, we had begun to use the net proceeds from this registered offering as described in our final prospectus filed with the SEC pursuant to Rule 424(b) and had invested all remaining net proceeds in cash and cash equivalents.

 

On May 13, 2013, we filed a registration statement on Form S-3 to register securities up to $20 million in value for future issuance in our capital raising activities. The registration statement became effective on June 14, 2013 and the Commission file number assigned to the registration statement is 333-188579.

There was no material change in the use of proceeds from the August 29, 2013 public offering closing for the August 2013 underwritten public offering as described in our final prospectus filed with the SEC pursuant to Rule 424(b) on August 29, 2013. Through December 31, 2013, we had not begun to use the net proceeds from this underwritten offering as described in our final prospectus filed with the SEC pursuant to Rule 424(b) and had invested all net proceeds in cash and cash equivalents.

The proceeds used during the threenine months ended DecemberMarch 31, 2013 were2014 from the July 17, 2012 registered public offering and no proceeds from the August 29, 2013 underwritten offering were used.direct offering.

 

Proceeds used in the six months ended December 31, 2013:   
Proceeds used in the nine months ended March 31, 2014:   
Indirect payments to directors and officers for database maintenance and development $15,720  $21,720 
Direct payments of compensation to directors  69,000   106,000 
Direct payments of salaries to officers  332,107   475,757 
Working capital  1,347,820   1,650,944 
Total proceeds used in the six months ended December 31, 2013 $1,764,647 
Total proceeds used in the nine months ended March 31, 2014 $2,254,421 

ITEM 5. OTHER INFORMATION

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers

On May 12, 2014, the Board of Directors of IsoRay, Inc. (the “Registrant” or “IsoRay”), on the recommendation of the Compensation Committee, approved a 2.5% increase to the base salary of all employees of IsoRay and its subsidiaries, effective July 1, 2014. This increase applies to all of IsoRay’s executive officers, other than the Company’s CEO whose compensation will be considered separately at a future meeting.

On May 14, 2014, the Board of Directors of IsoRay, on the recommendation of the Compensation Committee, approved a form of option agreement under IsoRay’s 2014 Employee Stock Option Plan (the “Plan”), which was adopted by the Board on January 16, 2014 and approved by the IsoRay shareholders on March 5, 2014. The Plan authorizes the grant of options to employees, officers, consultants and advisors who provide services to the Registrant or its subsidiaries and who the Plan administrator determines are eligible persons. The Plan is administered by a committee of independent directors or the full Board. The Plan will expire on the ten-year anniversary of its adoption, and 2 million shares of IsoRay common stock are reserved and available for issuance under the Plan. IsoRay's executive officers are eligible to receive grants of options under the Plan, in accordance with the terms and conditions of the Plan. The form of option agreement provides for a ten year option term and equal annual vesting over a three-year period.

The foregoing summaries of the Plan and the form of option agreement do not purport to be complete or describe all of their terms, and are qualified in their entirety by reference to the full text thereof, copies of which are filed herewith as Exhibits 4.32 and 4.33 and are incorporated by reference herein.

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ITEM 6. EXHIBITS

 

Exhibits:

 

4.32*2014 Employee Stock Option Plan
4.33*Form of Stock Option Agreement under the 2014 Employee Stock Option Plan
31.1*Rule 13a-14(a)/15d-14(a) Certification of Principal Executive Officer
  
31.2*Rule 13a-14(a)/15d-14(a) Certification of Principal Financial Officer
  
32**Section 1350 Certifications
  
101.INS***XBRL Instance Document
  
101.SCH***XBRL Taxonomy Extension Document
  
101.CAL***XBRL Taxonomy Extension Calculation Linkbase Document
  
101.DEF***XBRL Taxonomy Extension Definition Linkbase Document
  
101.LAB***XBRL Taxonomy Extension Label Linkbase Document
  
101.PRE***XBRL Taxonomy Extension Presentation Linkbase Document

 

* Filed herewith.

** Furnished herewith.

*** Furnished herewith. In accordance with Rule 406T of Regulation S-T, the information in these exhibits shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to liability under that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.

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.

 

Dated: February 14,May 15, 2014
  
 ISORAY, INC., a Minnesota corporation
  
 By   /s/ Dwight Babcock
 

Dwight Babcock, Chief Executive Officer

(Principal Executive Officer)

   
 By  /s/ Brien Ragle
 

Brien Ragle, Chief Financial Officer

(Principal Financial and Accounting Officer)

   

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