Table of Contents



UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

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

 

For the Quarterly Period Ended: DecemberMarch 31, 2017

2021or

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period fromto

 

Commission File No. 001-38247

 

aytu-logorgbsmallersize428.jpg

AYTU BIOSCIENCE,BIOPHARMA, INC.

(Exact name of registrant as specified in its charter)(www.aytubio.com)

 

Delaware

47-0883144

(State or other jurisdiction of

incorporation or organization)

(IRS Employer

Identification No.)

 

373 Inverness Parkway, Suite 206

Englewood, Colorado 80112

(Address of principal executive offices, including zip code)

 

(720) 437-6580

(Registrant’sRegistrants telephone number, including area code)

 

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

 

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

 

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

 

Large accelerated filer

Accelerated filer

Non-accelerated filer

(Do not check if a smaller reporting company)

Smaller reporting company

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

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

 

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.0001 per share

AYTU

The NASDAQ Stock Market LLC

As of February 1, 2018,May 10, 2021, there were 4,969,63825,170,596 shares of Common Stock outstanding.

 



 

AYTU BIOSCIENCE,BIOPHARMA, INC. AND SUBSIDIARY

SUBSIDIARIES FOR THE QUARTER ENDED DECEMBERMarch 31, 20172021

INDEX

 

INDEXPART IFINANCIAL INFORMATION

 

Page

PART I—FINANCIAL INFORMATION

Item 1.

Consolidated Financial Statements

1

Condensed Consolidated Balance Sheets as of  DecemberMarch 31, 20172021 (unaudited) and June 30, 20172020 (audited)

1

4

Condensed Consolidated Statements of Operations for the three and six monthsnine-months ended DecemberMarch 31, 20172021 (unaudited) and the three and six months ended DecemberMarch 31, 2016 (unaudited)2020 (unaudited)

2

6

Condensed Consolidated Statement of Stockholders’ Equity for the year-to-date interim periods ended March 31, 2021 (unaudited) and March 31, 2020 (unaudited)

3

7

Condensed Consolidated Statements of Cash Flows for the sixnine months ended DecemberMarch 31, 20172021 (unaudited) and the sixnine months ended DecemberMarch 31, 20162020 (unaudited)

4

8

Notes to Condensed Consolidated Financial Statements (unaudited)

5

10

Item 2.

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

18

35

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

22

39

Item 4.

Controls and Procedures

22

39

PART II—IIOTHER INFORMATION

Item 1. Legal Proceedings

40

Item 1.

Legal Proceeding23

Item 1A. Risk Factors

41

Item 1A.

Risk Factors23

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

23

52

Item 3.

Defaults Upon Senior Securities

23

52

Item 4.

Mine Safety Disclosures

23

52

Item

Item 5.

Other Information

23

52

Item 6. Exhibits

Exhibits23

53

SIGNATURES

24

56

 

 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding our anticipated future clinical and regulatory events, future financial position, business strategy and plans and objectives of management for future operations, are forward-looking statements. Forward looking statements are generally written in the future tense and/or are preceded by words such as “may,” “will,” “should,” “forecast,” “could,” “expect,” “suggest,” “believe,” “estimate,” “continue,” “anticipate,” “intend,” “plan,” or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. Such forward-looking statements include, without limitation: the planned expanded commercialization of our products and the potential future commercialization of our product candidates,candidates; our planned product candidate development strategy; our anticipated future cash position; the assimilation into our operations of acquired assets and entities; our plan to acquire additional assets; the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials; the anticipated designs of our future clinical trials; anticipated future regulatory submissionsgrowth rates; anticipated sales increases; anticipated net revenue increases; amounts of certain future expenses and events;costs of goods sold; anticipated increases to operating expenses, research and development expenses, and selling, general, and administrative expenses; and future events under our current and potential future collaborations.

These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including without limitation the risks described in “Risk Factors” in Part I,II Item 1A of our most recent Annual Report on Form 10-K,10- K, and in the reports we filedfile with the Securities and Exchange Commission. These risks are not exhaustive. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. YouForward-looking statements should not relybe relied upon forward-looking statements as predictions of future events. We cannot assure youcan provide no assurance that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. We assume no obligation to update or supplement forward-looking statements.statements, except as may be required under applicable law.

This Quarterly Report on Form 10-Q includes trademarks, such as Aytu, Natesto, ProstaScint, MiOXSYS, RedoxSYS,Karbinal®, Poly-Vi-Flor®, Tuzistra®, and Fiera,ZolpiMist®, consumer health products such as DiabaSens®, FlutiCare®, UriVarx® and Vesele®, as well as Beyond Human®, a specialty marketing platform, and the recently acquired ADHD products such as Adzenys XR-ODT®, Cotempla XR-ODT® and Adzenys ER®, which are protected under applicable intellectual property laws and we own or have the rights to. Solely for convenience, our trademarks and trade names referred to in this Quarterly Report on Form 10-Q may appear without the® orTM symbols, but such references are not intended to indicate in any way that we will not assert, to the fullest extent under applicable law, our rights to these trademarks and trade names.

 

3

 

AYTU BIOPHARMA, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

  

March 31,

  

June 30,

 
  

2021

  

2020

 
  

(Unaudited)

     

Assets

 

Current assets

        

Cash and cash equivalents

 $46,537,958  $48,081,715 

Restricted cash

  251,995   251,592 

Accounts receivable, net

  28,228,434   5,632,717 

Inventory

  16,575,757   9,999,441 

Prepaid expenses

  6,803,583   5,715,089 

Other current assets

  1,615,024   5,742,011 

Total current assets

  100,012,751   75,422,565 
         

Fixed assets, net

  5,557,727   258,516 

Operating lease right-of-use asset

  3,781,737   634,093 

Intangible assets, net

  96,236,796   48,854,561 

Goodwill

  65,802,636   28,090,407 

Other long-term assets

  164,954   32,981 

Total long-term assets

  171,543,850   77,870,558 

Total assets

 $271,556,601  $153,293,123 

 

PART I—FINANCIAL INFORMATIONSee the accompanying Notes to the Condensed Consolidated Financial Statements

 

Item 1.Consolidated Financial Statements
4

 

AYTU BIOSCIENCE,BIOPHARMA, INC. AND SUBSIDIARYSUBSIDIARIES

Condensed Consolidated Balance Sheets, contd

  

March 31,

  

June 30,

 
  

2021

  

2020

 
  

(Unaudited)

     

Liabilities

 

Current liabilities

        

Accounts payable and other

 $16,528,646  $11,824,560 

Accrued liabilities

  43,181,920   8,645,984 

Accrued compensation

  10,510,228   3,117,177 
Notes payable     982,076 
Short-term line of credit  4,738,825    

Current portion of debt

  725,357    

Current portion of operating lease liabilities

  910,885   300,426 

Current portion of fixed payment arrangements

  1,998,012   2,340,166 

Current portion of CVR liabilities

  911,826   839,734 

Current portion of contingent consideration

  4,177,282   713,251 

Total current liabilities

  83,682,981   28,763,374 
         
Long-term debt, net of current portion  16,930,682    

Long-term operating lease liability, net of current portion

  2,871,845   725,374 

Long-term fixed payment arrangements, net of current portion

  9,422,768   11,171,491 

Long-term CVR liabilities, net of current portion

  4,679,227   4,731,866 

Long-term contingent consideration, net of current portion

  10,726,691   12,874,351 

Other long-term liabilities

  92,894   11,371 

Total liabilities

  128,407,088   58,277,827 
         

Commitments and contingencies (Note 10)

        
         

Stockholders' equity

        

Preferred Stock, par value $.0001; 50,000,000 shares authorized; shares issued and outstanding 0 and 0, respectively as of March 31, 2021 and June 30, 2020, respectively.

      

Common Stock, par value $.0001; 200,000,000 shares authorized; shares issued and outstanding 23,457,887 and 12,583,736, respectively as of March 31, 2021 and June 30, 2020.

  2,346   1,259 

Additional paid-in capital

  302,448,362   215,024,216 

Accumulated deficit

  (159,301,195)  (120,010,179)

Total stockholders' equity

  143,149,513   95,015,296 

Total liabilities and stockholders' equity

 $271,556,601  $153,293,123 

See accompanying Notes to the Condensed Consolidated Financial Statements

5

AYTU BIOPHARMA, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations

(unaudited)

 

  December 31,  June 30, 
  2017  2017 
       
Assets       
Current assets        
Cash and cash equivalents $3,908,183  $802,328 
Restricted cash  75,534   75,214 
Accounts receivable, net  1,377,436   528,039 
Inventory, net  1,379,806   1,312,221 
Prepaid expenses and other  1,003,766   310,760 
Total current assets  7,744,725   3,028,562 
         
Fixed assets, net  560,624   647,254 
Developed technology, net  1,254,309   1,337,333 
Customer contracts, net  74,667   77,667 
Trade names, net  152,438   164,037 
Natesto asset, net  8,571,710   9,231,072 
Goodwill  238,426   238,426 
Patents, net  258,611   271,278 
Deposits  2,888   2,888 
Total long-term assets  11,113,673   11,969,955 
         
Total assets $18,858,398  $14,998,517 
         
Liabilities and Stockholders’ Equity        
Current liabilities        
Accounts payable and other $3,414,854  $2,220,400 
Accrued liabilities  257,631   782,536 
Accrued compensation  837,290   339,704 
Deferred rent  4,787   6,673 
Current contingent consideration  286,339   261,155 
Total current liabilities  4,800,901   3,610,468 
         
Long-term contingent consideration  7,726,698   7,386,782 
Long-term deferred rent  -   1,451 
Warrant derivative liability  3,300,213   - 
Total liabilities  15,827,812   10,998,701 
         
Commitments and contingencies (Note 6)        
         
Stockholders’ equity        
Preferred Stock, par value $.0001; 50,000,000 shares authorized; shares issued and outstanding 1,900 and 0, respectively as of December 31, 2017 and June 30, 2017  1   - 
Common Stock, par value $.0001; 100,000,000 shares authorized; shares issued and outstanding 4,894,638 and 824,831, respectively as of December 31, 2017 and June 30, 2017  489   82 
Additional paid-in capital  80,017,545   73,069,463 
Accumulated deficit  (76,987,449)  (69,069,729)
Total stockholders’ equity  3,030,586   3,999,816 
         
Total liabilities and stockholders’ equity $18,858,398  $14,998,517 
  

Three Months Ended

  

Nine Months Ended

 
  

March 31,

  

March 31,

 
  

2021

  

2020

  

2021

  

2020

 

Revenues

                

Product revenue, net

 $13,482,282  $8,156,173  $42,149,561  $12,771,235 
                 

Operating expenses

                

Cost of sales

  13,682,297   1,998,659   23,499,842   2,980,425 

Research and development

  389,262   78,502   858,698   223,197 

Selling, general and administrative

  12,851,087   9,190,386   35,825,175   19,494,368 
Acquisition related costs  1,536,800   311,083   2,849,037   1,533,723 
Restructuring costs  4,818,064      4,874,723   135,981 

Amortization and impairment of intangible assets

  5,870,436   1,370,986   9,039,597   2,899,553 

Total operating expenses

  39,147,946   12,949,616   76,947,072   27,267,247 

Loss from operations

  (25,665,664)  (4,793,443)  (34,797,511)  (14,496,012)

Other (expense) income

                

Other (expense), net

  (425,425)  (538,862)  (1,555,924)  (1,181,206)

Gain / (Loss) from change in fair value of contingent consideration

  631,298      (2,680,022)   
Gain from derecognition of contingent consideration           5,199,806 

Gain from warrant derivative liability

           1,830 

Loss on debt exchange

        (257,559)   

Total other (expense) income

  205,873   (538,862)  (4,493,505)  4,020,430 

Net loss

 $(25,459,791) $(5,332,305) $(39,291,016) $(10,475,582)

Weighted average number of common shares outstanding

  18,092,465   3,527,530   14,490,219   2,261,697 

Basic and diluted net loss per common share

 $(1.41) $(1.51) $(2.71) $(4.63)

 

 TheSee the accompanying notes are an integral part of these consolidated financial statements.Notes to the Condensed Consolidated Financial Statements.

 

1
6

 

AYTU BIOSCIENCE,BIOPHARMA, INC. AND SUBSIDIARY

Consolidated Statements of Operations

(unaudited)

  Three Months Ended
December 31,
  Six Months Ended
December 31,
 
  2017  2016  2017  2016 
             
             
Product revenue $1,051,154  $794,172  $2,127,522  $1,492,152 
Total revenue  1,051,154   794,172   2,127,522   1,492,152 
                 
Operating expenses                
Cost of sales  385,411   551,293   672,612   743,217 
Research and development  (277,486)  263,457   (136,532)  495,479 
Research and development - related party (Note 9)  -   47,998   -   95,996 
Sales, general and administrative  4,553,366   3,642,332   9,171,769   9,347,082 
Sales, general and administrative - related party (Note 9)  -   50,772   -   101,544 
Amortization and impairment of intangible assets  383,811   437,014   769,652   874,029 
Total operating expenses  5,045,102   4,992,866   10,477,501   11,657,347 
                 
Loss from operations  (3,993,948)  (4,198,694)  (8,349,979)  (10,165,195)
                 
Other income (expense)                
Interest expense  (196,781)  (388,085)  (385,526)  (803,465)
Derivative income  518,051   266,757   817,785   196,148 
Unrealized (loss) gain on investment  -   (497,164)  -   230,936 
Total other income (expense)  321,270   (618,492)  432,259   (376,381)
                 
Net loss $(3,672,678) $(4,817,186) $(7,917,720) $(10,541,576)
Weighted average number of Aytu common shares outstanding  4,113,256   392,540   2,481,110   295,546 
                 
Basic and diluted Aytu net loss per common share $(0.89) $(12.27) $(3.19) $(35.67)

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

2

SUBSIDIARIES

 

AYTU BIOSCIENCE, INC. AND SUBSIDIARY

Condensed Consolidated Statement of Stockholders’Stockholders Equity

(unaudited)

  Preferred Stock  Common Stock  Additional
paid-in
  Accumulated  Total Stockholders’ 
  Shares  Amount  Shares  Amount  capital  Deficit  Equity 
                      
Balance - June 30, 2017  -  $-   824,831  $82  $73,069,463  $(69,069,729) $3,999,816 
                             
Stock-based compensation (unaudited)  -   -   -   -   275,688   -   275,688 
Issuance of restricted stock (unaudited)  -   -   692,000   69   103,566   -   103,635 
Earn-out payment to Nuelle shareholders (unaudited)  -   -   64,150   6   249,994   -   250,000 
Issuance of preferred and common stock, net of $1,402,831 in cash issuance costs (unaudited)      2,250   1   3,196,665   320   6,318,846   -   6,319,167 
Preferred stocks converted in common stock (unaudited)  (350)      116,666   12   (12)  -   - 
Adjustment for rounding of shares due to stock split (unaudited)  -   -   326   -   -   -   - 
Net loss (unaudited)  -   -   -   -   -   (7,917,720)  (7,917,720)
                             
Balance - December 31, 2017 (unaudited)  1,900  $1   4,894,638  $489  $80,017,545  $(76,987,449) $3,030,586 

The accompanying notes are an integral part of these consolidated financial statements.(unaudited unless indicated otherwise)

 

3
  

Preferred Stock

  

Common Stock

  

Additional paid-in

  

Accumulated

  

Total Stockholders'

 
  

Shares

  

Amount

  

Shares

  

Amount

  

capital

  

Deficit

  

Equity

 

BALANCE - June 30, 2019 (audited)

  3,594,981  $359   1,753,808  $176  $113,476,783  $(106,389,500) $7,087,818 

Stock-based compensation

              165,171      165,171 

Preferred stock converted in common stock

  (443,833)  (44)  44,384   5   39       

Net loss

                 (4,929,030)  (4,929,030)
BALANCE - September 30, 2019  3,151,148  $315   1,798,192  $181  $113,641,993  $(111,318,530) $2,323,959 
                             
Stock-based compensation    $     $  $162,264  $  $162,264 
Issuance of Series F preferred stock from October 2019 private placement financing, net of $741,650 issuance costs  10,000   1         5,249,483      5,249,484 
Warrants issued in connection with the private placement              4,008,866      4,008,866 
Issuance of Series G preferred stock due to acquisition of the Cerecor portfolio of pediatrics therapeutics  9,805,845   981         5,558,933      5,559,914 
Preferred stock converted in common stock  (2,751,148)  (275)  275,115   28   247       
Net loss              -   (214,247)  (214,247)

BALANCE - December 30, 2019

  10,215,845  $1,022   2,073,307  $209  $128,621,786  $(111,532,777) $17,090,240 
                             
Stock-based compensation    $   106,792  $11  $263,380  $  $263,391 
Cashless warrant exercise        791,577   80   (80)      
Issuance of Series H preferred stock and common stock due to acquisition of Innovus  1,997,902   200   380,972   39   4,405,945      4,406,184 
Preferred stock converted in common stock  (2,407,902)  (241)  1,239,791   124   92,997      92,880 
Warrant exercises        1,708,300   171   22,989,495      22,989,666 
Issuance of common stock, net of $4,523,884 in cash issuance costs        3,636,528   364   33,278,392      33,278,756 
Warrants issued in connection with the registered offering              9,723,161      9,723,161 
Warrants issued in connection with the registered offering to the placement agents, non-cash issuance costs              1,458,973      1,458,973 
CVR payouts        123,777   13   1,732,857      1,732,870 
Net loss                 (5,332,305)  (5,332,305)
BALANCE - March 31, 2020  9,805,845  $981   10,061,044  $1,011  $202,566,906  $(116,865,082) $85,703,816 

 

  

Preferred Stock

  

Common Stock

  

Additional paid-in

  

Accumulated

  

Total Stockholders'

 
  

Shares

  

Amount

  

Shares

  

Amount

  

capital

  

Deficit

  

Equity

 

BALANCE - June 30, 2020 (audited)

    $   12,583,736  $1,259  $215,024,216  $(120,010,179) $95,015,296 

Stock-based compensation

              454,918      454,918 

Issuance costs

              (101,537)     (101,537)

Net loss

                 (4,305,931)  (4,305,931)
BALANCE - September 30, 2020    $   12,583,736  $1,259  $215,377,597  $(124,316,110) $91,062,746 
                             
Stock-based compensation    $     $  $508,059  $  $508,059 
Exchange of debt for common stock        130,081   13   1,057,546      1,057,559 
Issuance of common stock, net of issue costs and warrants        5,169,076   516   28,316,928      28,317,444 
Warrants issued in connection with common stock offering              1,272,154      1,272,154 
Net loss                 (9,525,294)  (9,525,294)

BALANCE - December 31, 2020

    $   17,882,893  $1,788  $246,532,284  $(133,841,404) $112,692,668 
                             
Stock-based compensation    $     $  $1,381,429  $  $1,381,429 
Issuance of common stock due to acquisition, net of $137,735 in costs        5,471,804   548   53,102,370      53,102,918 
Estimated fair value of replacement equity awards              432,289      432,289 
CVR payouts        103,190   10   999,990      1,000,000 
Net loss                 (25,459,791)  (25,459,791)
BALANCE - March 31, 2021    $   23,457,887  $2,346  $302,448,362  $(159,301,195) $143,149,513 

 

See the accompanying Notes to the Condensed Consolidated Financial Statements

AYTU BIOSCIENCE,BIOPHARMA, INC. AND SUBSIDIARYSUBSIDIARIES

Condensed Consolidated Statements of Cash Flows

(unaudited)

 

  Six Months Ended
December 31,
 
  2017  2016 
       
Cash flows from operating activities        
Net loss $(7,917,720) $(10,541,576)
Adjustments to reconcile net loss to cash provided by (used in) operating activities        
Stock-based compensation expense  275,688   1,425,133 
Issuance of restricted stock  103,635   156,814 
Depreciation, amortization and accretion  1,315,063   1,722,965 
Derivative (income)  (817,785)  (196,148)
Amortization of prepaid research and development - related party (Note 9)  -   60,992 
Unrealized (gain) on investment  -   (230,936)
Compensation through issuance of stock  -   509,996 
Issuance of warrants to initial investors  -   596,434 
Adjustments to reconcile net loss to net cash used in operating activities:        
(Increase) in accounts receivable  (849,397)  (419,966)
(Increase) decrease in inventory  (67,585)  85,741 
(Increase) in prepaid expenses and other  (454,595)  (221,015)
Increase (decrease) in accounts payable and other  1,124,558   (195,836)
(Decrease) in accrued liabilities  (524,905)  (238,395)
Increase (decrease) in accrued compensation  497,586   (681,432)
(Decrease) in deferred rent  (3,337)  (1,350)
Net cash used in operating activities  (7,318,794)  (8,168,579)
         
Cash flows used in investing activities        
Purchases of property and equipment  (12,195)  (44,876)
Installment payment for Natesto asset  -   (2,000,000)
Installment payment for Primsol asset  -   (750,000)
Net cash used in investing activities  (12,195)  (2,794,876)
         
Cash flows from financing activities        
Issuance of preferred, common stock and warrants  11,839,995   - 
Issuance costs related to preferred, common stock and warrants  (1,402,831)  - 
Issuance of common stock to Lincoln Park Capital  -   631,481 
Costs related to sale of common stock  -   (24,247)
Registered offering of common stock and warrants  -   8,602,500 
Registered offering costs  -   (997,865)
Over-allotment warrants purchased by placement agents  -   2,852 
Net cash provided by financing activities  10,437,164   8,214,721 
         
Net change in cash, cash equivalents and restricted cash  3,106,175   (2,748,734)
Cash, cash equivalents and restricted cash at beginning of period  877,542   8,054,190 
Cash, cash equivalents and restricted cash at end of period $3,983,717  $5,305,456 
         
Non-cash transactions:        
Warrants issued to investors and underwriters (see Note 5) $4,117,997  $- 
Revenue share payment to Jazz $7,385  $- 
Earn-out payment to Nuelle Shareholders $250,000  $- 
Fixed assets included in accounts payable $62,512  $61,241 
Warrants issued in connection with the equity financing to the placement agents $-  $292,630 
  

Nine Months Ended

 
  

March 31,

 
  

2021

  

2020

 
         

Operating Activities

        

Net loss

 $(39,291,016) $(10,475,582)

Adjustments to reconcile net loss to cash used in operating activities:

        

Depreciation, amortization and accretion

  10,301,150   3,780,310 

Stock-based compensation expense

  2,485,330   590,826 
Loss from change in fair value of contingent consideration  2,680,022    

Inventory write-down

  7,227,230    

(Gain) from derecognition of contingent consideration

     (5,199,806)
(Gain) on the change in fair value of CVR payout     (267,130)
Amortization of senior debt issuance costs and discounts  (21,916)   

Loss on sale of equipment

  112,110    

(Gain) on termination of lease

  (343,185)   
Loss on debt exchange  257,559    

Changes in allowance for bad debt

  335,036    

Derivative income

     (1,830)

Changes in operating assets and liabilities:

        

Accounts receivable

  1,772,274   (8,183,810)
Inventory  (4,390,470)  (345,452)

Prepaid expenses

  1,607,170   (1,611,681)

Other current assets

  6,065,996   (358,022)

Accounts payable and other

  (6,155,583)  (4,912,245)

Accrued liabilities

  (5,556,614)  6,761,319 

Accrued compensation

  3,263,723   271,560 
Fixed payment arrangements     (657,655)

Operating lease liabilities

  (26,648)   

Net cash used in operating activities

  (19,677,832)  (20,609,198)
         

Investing Activities

        

Deposit

  (3,923)   

Contingent consideration payment

  (683,241)  (151,648)
Cash received from acquisition  15,721,797   390,916 
Cash payment for business acquisition  (15,398,727)  (5,850,000)

Net cash used in investing activities

  (364,094)  (5,610,732)
         

Financing Activities

        
Issuance of preferred, common stock and warrants  32,249,652   58,999,666 

Issuance cost related to registered offering

  (4,430,516)  (5,280,426)
Payments made on short-term line of credit  (5,968,290)   
Warrant exercises     22,989,666 
Preferred stock converted in common stock     92,880 
Issuance of note payable     640,000 

Debt payment

  (318,181)   

Payments made to fixed payment arrangements

  (3,034,093)   

Net cash provided by financing activities

  18,498,572   77,441,786 
         

Net change in cash, restricted cash and cash equivalents

  (1,543,354)  51,221,856 

Cash, restricted cash and cash equivalents at beginning of period

  48,333,307   11,294,227 

Cash, restricted cash and cash equivalents at end of period

 $46,789,953  $62,516,083 

 

TheSee the accompanying notes are an internal part of these consolidated financial statements.Notes to the Condensed Consolidated Financial Statements.

 

 

AYTU BIOSCIENCE,BIOPHARMA, INC. AND SUBSIDIARYSUBSIDIARIES

 

Condensed Consolidated Statements of Cash Flows, contd

(unaudited)

  

Nine Months Ended

 
  

March 31,

 

Supplemental disclosures of cash and non-cash investing and financing transactions

 

2021

  

2020

 

Warrants issued to underwriters

 $1,628,293  $- 

Cash paid for interest

  448,603   392,641 

Fair value of right-to-use asset and related lease liability

  66,182   354,929 
Issuance of Series G preferred stock due to acquisition of the Cerecor portfolio of pediatrics therapeutics     5,559,914 
Issuance of Series H preferred stock due to acquisition of the Innovus     12,805,263 
Issuance related to acquisition of Neos  53,240,653    
Fair value of non-cash assets acquired  104,321,912    
Fair value of liabilities assumed  88,699,892    
Estimated fair value of replacement equity awards  432,289     
Inventory payment included in accounts payable     460,416 
Return deductions received by Cerecor     2,000,000 
Contingent value rights payout  1,000,000    

Contingent consideration included in accounts payable

     27,571 
Issuance of restricted stock     107 
Cashless warrant exercises     792 
Debt exchange  1,057,559    

Fixed payment arrangements included in accrued liabilities

  1,575,000   501,766 

Exchange of convertible preferred stock into common stock

 $ –  $1,559 

See the accompanying Notes to the Condensed Consolidated Financial Statements

AYTU BIOPHARMA, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(unaudited)

 

Note 1 –

1. Nature of Business, Financial Condition, Basis of Presentation Business Combinations, Divestitures, License/Supply Agreement and Merger

 

BusinessNature of Business.

Aytu BioScience,BioPharma, Inc. (“Aytu”, the “Company” or “we”) is a commercial-stage specialty pharmaceutical company focused on commercializing novel therapeutics and consumer healthcare products. The Company currently operates the Aytu BioPharma business, consisting of the prescription pharmaceutical products (the “Rx Portfolio”), and Aytu consumer healthcare products business (the “Consumer Health Portfolio”). The Rx Portfolio is focused on commercializing prescription pharmaceutical products for the treatment of attention deficit hyperactivity disorder ("ADHD"), allergies, insomnia, and various pediatric conditions. The Aytu consumer health business is focused on commercializing consumer healthcare products. The Company was incorporated as Rosewind Corporation on August 9, 2002 in the State of Colorado. AytuColorado and was re-incorporated in the state of Delaware on June 8, 2015. Aytu is

The Rx Portfolio consists of (i) Adzenys XR-ODT (amphetamine) extended-release orally disintegrating tablets, Cotempla XR-ODT (methylphenidate) extended-release orally disintegrating tablets and Adzenys-ER (amphetamine) extended-release oral suspension for the treatment of attention deficit hyperactivity disorder (ii) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various formulations for infants and children with fluoride deficiency, (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions, (iv) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, (v) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup and (vi) a commercial-stage specialty life sciences company concentrating on developinggeneric Tussionex (hydrocodone and commercializingchlorpheniramine) (“generic Tussionex”), extended-release oral suspension for the treatment of cough and upper respiratory symptoms of a cold.

The Consumer Health Portfolio consists of over twenty consumer health products with an initial focus on urological diseases and conditions. Aytu is currently focused on addressing significant medical needscompeting in the areas of hypogonadism, male infertility, andlarge healthcare categories including diabetes, men's health, sexual wellness and vitality.respiratory health commercialized through direct-to-consumer marketing channels utilizing the Company's proprietary Beyond Human marketing and sales platform and on e-commerce platforms.

On March 31, 2021, the Company and Acerus Pharmaceuticals Corporation (“Acerus”) entered into a termination and transition agreement (the “Termination Agreement”) to terminate the License and Supply Agreement previously entered into on July 29, 2019 related to Natesto®. Pursuant to the Termination Agreement, the Company ceased all sales, marketing and promotion of Natesto, and Acerus agreed to pay the Company an aggregate amount of $7.5 million, payable in equal monthly installment payments of $250,000 for a period of 30 consecutive months. 

On March 19, 2021, the Company acquired Neos Therapeutics, Inc. (“Neos”), a commercial-stage pharmaceutical company developing and manufacturing central nervous system-focused products (the “Neos Merger”). Neos commercializes Adzenys XR-ODT, Cotempla XR-ODT and Adzenys-ER in the United States using Neos’ internal commercial organization. These commercial products are extended-release (“XR”) medications in patient-friendly, orally disintegrating tablet (“ODT”) or oral suspension dosage forms that utilize Neos' microparticle modified-release drug delivery technology platform. Neos received approval from the U.S. Food and Drug Administration (“FDA”) for these three products. In addition, Neos manufactures and sells a generic Tussionex.

In April of 2020, the Company entered into a licensing agreement with Cedars-Sinai Medical Center to secure worldwide rights to various potential esophageal and nasopharyngeal uses of Healight, an investigational medical device platform technology. Healight has demonstrated safety and efficacy in a proof-of-concept clinical study in SARS-CoV-2 patients, and the Company plans to advance this technology to further assess its safety and efficacy in additional randomized, controlled human studies, initially focused on SARS-CoV-2 patients.

The Company’s strategy is to continue building its portfolio of revenue-generating products, leveraging its commercial team’s expertise to build leading brands within large therapeutic markets.

Financial Condition. As of March 31, 2021, the Company had approximately $46.8 million of cash, cash equivalents and restricted cash. The Company’s operations have historically consumed cash and are expected to continue to consume cash.

Revenues for the three- and nine-months ended March 31, 2021 were $13.5 million and $42.1 million, compared to $8.2 million and $12.8 million for the same periods ended March 31, 2020, an increase of approximately 65% and 230%, respectively. Revenue is expected to increase over time, which will allow the Company to rely less on the Company's existing cash balance and proceeds from financing transactions. Cash used by operations during the nine-months ended March 31, 2021 was $19.7 million compared to $20.6 million for the nine-months ended March 31, 2020. The decrease is due primarily to a decrease in working capital and pay down of other liabilities.

As of the date of this Report, the Company expects its costs for operations to increase as the Company integrates the Neos acquisition, invests in new product development, continues to focus on revenue growth through increasing product sales and additional acquisitions. The Company’s current assets totaling approximately $100.0 million as of March 31, 2021 plus the proceeds expected from ongoing product sales will be used to fund existing operations. The Company may continue to access the capital markets from time-to-time when market conditions are favorable. The timing and amount of capital that may be raised is dependent on the terms and conditions upon which investors would require to provide such capital. There is no guarantee that capital will be available on terms favorable to the Company and its stockholders, or at all. Upon closing of the Neos merger, on March 19, 2021, the Company paid down $15.4 million of Neos' senior secured long-term debt, including accrued interest and $5.5 million of merger costs incurred by Neos. The Company did not issue any common stock under the Company's at-the-market offering program during the three months ended March 31, 2021. As of the date of this report, the Company has adequate capital resources to complete its near-term operating objectives. 

Since the Company has sufficient cash on-hand as of March 31, 2021 to cover potential net cash outflows for the twelve months following the filing date of this Quarterly Report, the Company reports that there exists no indication of substantial doubt about its ability to continue as a going concern.

If the Company is unable to raise adequate capital in the future when it is required, the Company's management can adjust its operating plans to reduce the magnitude of the Company's capital need under its existing operating plan. Some of the adjustments that could be made include delays of and reductions to commercial programs, reductions in headcount, narrowing the scope of the Company’s commercial plans, or reductions or delays to its research and development programs. Without sufficient operating capital, the Company could be required to relinquish rights to products or renegotiate to maintain such rights on less favorable terms than it would otherwise choose. This may lead to impairment or other charges, which could materially affect the Company’s balance sheet and operating results.

 

Basis of PresentationPresentation.

These The unaudited condensed consolidated financial statements contained in this report represent the financial statements of Aytuthe Company and its subsidiary,wholly-owned subsidiaries, Innovus Pharmaceuticals, Inc., Aytu Women’s Health, LLC. TheseTherapeutics, LLC and Neos Therapeutics, Inc. The unaudited consolidated financial statements should be read in conjunction with Aytu’sthe Company's Annual Report on Form 10-K for the year ended June 30, 2017,2020, which included all disclosures required by generally accepted accounting principles in the United States (“GAAP”). In the opinion of management, these unaudited consolidated financial statements contain all adjustments necessary to present fairly the financial position of Aytu for the balance sheet,Company and the results of operations and cash flows for the interim periods presented. The results of operations for the period ended DecemberMarch 31, 20172021 are not necessarily indicative of expected operating results for the full year. The information presented throughout this report, as of March 31, 2021 and for the periodthree and nine months ended DecemberMarch 31, 20172021, and 20162020, is unaudited.

 

Through a multi-step reverse triangular merger in April 2015, Vyrix Pharmaceuticals, Inc. (“Vyrix’’) and Luoxis Diagnostics, Inc. (“Luoxis’’) merged with and into ourOn December 8, 2020, the Company (herein referred to as the Merger) and we abandoned our pre-merger business plans to solely pursue the specialty healthcare market, including the business of Vyrix and Luoxis. In the Merger, we acquired the RedoxSYS, MiOXSYS and Zertane products. On June 8, 2015, we reincorporated as a domestic Delaware corporation under Delaware General Corporate Law and changed our name from Rosewind Corporation to Aytu BioScience, Inc., and effected a reverse stock split in which each common stockholder received one share of common stock for every 12.174 shares held. On June 30, 2016, Aytu effected another reverse stock split in which each common stockholder received one share of common stock for every 12 shares held. On August 25, 2017, Aytu effected a third reverse stock split in which each common stockholder received one share of common stock for every 2010 shares held (herein referred to collectively as the “Reverse Stock Splits”Split”). All share and per share amounts in this report have been adjusted to reflect the effect of thesethe Reverse Stock Splits.Split.

 

Business Combination—ProstaScint

In May 2015, Aytu entered into and closed on an asset purchase agreement with Jazz Pharmaceuticals, Inc. (“Jazz Pharmaceuticals”). Pursuant to the agreement, Aytu purchased assets related to the Jazz Pharmaceuticals’ product known as ProstaScint® (capromab pendetide), including certain intellectual property and contracts, and the product approvals, inventory and work in progress (together, the “ProstaScint Business’’), and assumed certainUse of Jazz Pharmaceuticals’ liabilities, including those related to product approvals and the sale and marketing of ProstaScint. The purchase price consisted of an upfront payment of $1.0 million. We also agreed to pay an additional $500,000, which was paid after the transfer of the ProstaScint-related product inventory, and $227,000 which was paid September 30, 2015 (which represents a portion of certain FDA fees). The total fair value consideration for the purchase was $2.4 million. We will also pay 8% on net sales made after October 2017, payable up to a maximum aggregate payment of an additional $2.5 million. The contingent consideration was initially valued at $664,000 and was revalued as of June 30, 2017 at $54,000 using the discounted cash flow methodology. As of December 31, 2017, the contingent consideration increased by $13,000 due to accretion.Estimates

Pursuant to the asset purchase agreement, we are required to make our first revenue share payment to Jazz Pharmaceuticals in the upcoming quarter, which is approximately $7,400.

5

 

The Company’s allocationpreparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent consideration, transferred for ProstaScint ascontingent value rights ("CVRs"), and fixed payment obligations at the date of the purchase datefinancial statements and the reported amounts of May 20, 2015 was as follows:

  Fair Value 
    
Tangible assets $727,000 
Intangible assets  1,590,000 
Goodwill  74,000 
Total assets acquired $2,391,000 

The intangible assets for ProstaScint were originally recognized upon the closing of the acquisitionrevenue and included developed technology of $790,000, customer contracts of $720,000 and trade names of $80,000, each of which began amortizing over a ten-year period. At June 30, 2017, the ProstaScint asset was determined to be impaired based upon sales projections at that time and because we decided to discontinue sales of ProstaScint mid-fiscal 2019 upon expiration of the product. The valueexpenses for the intangible assets were adjustedreporting period. On an ongoing basis, the Company evaluates its estimates, including, but not limited to, $54,000 for developed technology, $7,000 for trade names and $0 for customer contracts. The amortization expense was $12,000 and $40,000 for the three months ended December 31, 2017 and 2016, respectively. The amortization expense was $24,000 and $80,000 for the six months ended December 31, 2017 and 2016, respectively.

Business Combination—Primsol

In October 2015, Aytu entered into and closed on an Asset Purchase Agreement with FSC Laboratories, Inc. (“FSC”). Pursuant to the agreement, Aytu purchased assets related to FSC’s product known as Primsol® (trimethoprim solution), including certain intellectual property and contracts, inventory, work in progress and all marketing and sales assets and materials related solely to Primsol (together, the “Primsol Business”), and assumed certain of FSC’s liabilities, including those related to the saledetermination of the fair value of equity awards, the fair value of identified assets and marketingliabilities acquired in business combinations, net realizable value of Primsol arising afterinventory, the closing.useful lives of property and equipment, intangible assets, impairment of long-lived and intangible assets, including goodwill, provisions for doubtful accounts receivable, certain accrued expenses, and the discount rate used in measuring lease liabilities. These estimates and assumptions are based on the Company’s historical results and management’s future expectations. Actual results could differ from those estimates.

 

Aytu paid $500,000 at closingReclassification

The Company historically presented accrued distributor fees as a reduction to accounts receivable. However, beginning this quarterly report and for the purchasecomparative periods presented, accrued distributors fees will be presented in accrued liabilities instead of accounts receivable. As of June 30, 2020, accrued distributor fees included in accounts receivable, net on the Primsol Business,balance sheet was $457,000. This reclassification will have no impact on the Company's statements of operation and paid an additional $142,000,cash flows presented in this quarterly report.

Significant Accounting Policies

 

The Company’s allocationsignificant accounting policies are discussed in Note 2—Summary of consideration transferred for Primsol as of the purchase date of October 5, 2015 was as follows:

  Fair Value 
    
Tangible assets��$182,000 
Intangible assets  1,470,000 
Goodwill  147,000 
Total assets acquired $1,799,000 

Included in tangible assets was $102,000 of inventorySignificant Accounting Policies and $80,000 of work-in-process inventory. IncludedRecent Accounting Pronouncements in the intangible assets was developed technology of $520,000, customer contracts of $810,000Annual Report. There have been no significant changes to these policies that have had a material impact on the Company’s unaudited condensed consolidated financial statements and trade names of $140,000, each of which was being amortized over a six-year period. Amortization expense of $0 and $61,000 was recognized inrelated notes during the three and nine months ended DecemberMarch 31, 2017 and 2016, respectively. The amortization expense was $0 and $122,000 for the six months ended December 31, 2017 and 2016, respectively.

Divestiture – Primsol

In March 2017, we entered into and closed on an Asset Purchase Agreement with Allegis Holdings, LLC (the “Purchaser”). Pursuant to the agreement, we sold to the Purchaser all of the assets related to our product known as Primsol, including certain intellectual property and contracts, inventory, work in process and all marketing assets and materials related solely to Primsol (together, the “Primsol Asset”). We retain any liability associated with the Primsol Asset that occurred prior to the closing. The Purchaser paid us $1,750,000 in cash at the closing for the Primsol Asset. We recognized a gain of approximately $428,000 on the sale which is included in selling, general and administrative expense on our statement of operations.

Based on our evaluation of the transaction, and because the Primsol Asset was not a material part of our business, the criteria for discontinued operations was not met. Therefore, the gain is included in continuing operations.

6

License and Supply Agreement—Natesto

In April 2016, Aytu entered into and closed a license and supply agreement to acquire the exclusive U.S. rights to distribute Natesto® (testosterone) nasal gel from Acerus Pharmaceuticals Corporation, or Acerus. The rights we acquired effective upon the expiration of the former licensee’s rights, which occurred on June 30, 2016. The license’s term runs for the greater of eight years or until the expiry of the latest to expire patent including claims covering Natesto and until the entry on the market of at least one AB-rated generic product.

Aytu made an upfront payment of $2.0 million to Acerus upon execution of the agreement. In October 2016, we paid an additional $2.0 million, and in January 2017, Aytu paid the final upfront payment of $4.0 million. Aytu also purchased, on April 28, 2016, an aggregate of 12,245,411 shares of Acerus common stock for Cdn. $2.5 million (approximately US $2.0 million), with a purchase price per share equal to Cdn. $0.207 or approximately US $0.16 per share. These shares were a held for sale security and were recognized at fair market value. Aytu agreed to refrain from disposing these shares until after August 29, 2016. During the second half of fiscal 2017, Aytu sold all of these shares. The gross proceeds from the sales were $1.1 million, the cost of the sales were $92,000, and we recognized a loss on investment of $1.0 million. 

In addition to the upfront payments, we agreed to make the following one-time, non-refundable milestone payments to Acerus within 45 days of the occurrence of the below events. The maximum aggregate amount payable under such milestone payments is $37.5 million.

$2.5 million if net sales during any four consecutive calendar quarter period equal or exceed $25.0 million (the “First Milestone”); the First Milestone payment is required to be paid even if the threshold is not met in the event that the agreement is terminated for any reason other than material breach by Acerus, bankruptcy of either party, or termination by Acerus because it believes the amounts payable to Aytu for agreed upon trial work would no longer make the agreement economically viable for Acerus;
$5.0 million if net sales during any four consecutive calendar quarter period equal or exceed $50.0 million;
$7.5 million if net sales during any four consecutive calendar quarter period equal or exceed $75.0 million;
$10.0 million if net sales during any four consecutive calendar quarter period equal or exceed $100.0 million; and
$12.5 million if net sales during any four consecutive calendar quarter period equal or exceed $125.0 million.

The fair value of the net identifiable Natesto asset acquired was determined to be $10.5 million, which is being amortized over eight years. The amortization expense for each of the three months ended December 31, 2017 and 2016 was $330,000. The amortization expense for the six months ended December 31, 2017 and 2016 was $659,000.

The contingent consideration for Natesto was valued at $3.2 million using a Monte Carlo simulation, as of June 30, 2016. As of June 30, 2017, the contingent consideration was revalued and increased to $5.7 million using a Monte Carlo simulation and was based on an increase in estimated future sales of Natesto. The contingent consideration accretion expenses for the three months ended December 31, 2017 and 2016 was $169,000 and $58,000, respectively. The contingent consideration accretion expense for the six months ended December 31, 2017 and 2016 was $330,000 and $104,000, respectively, resulting in the contingent consideration value of $6.0 million as of December 31, 2017.

Merger/Subsidiary 

In May 2017, Aytu Women’s Health, LLC., a wholly-owned subsidiary of Aytu, acquired Nuelle, Inc., or Nuelle, a women’s sexual health company. This transaction expanded our product portfolio with the addition of the Fiera® personal care device for women.

In the Merger, (i) each share of Nuelle common stock and each option or warrant to purchase Nuelle stock were cancelled, and (ii) each share of Nuelle preferred stock was converted into the right to receive shares of Aytu common stock. At the closing, Nuelle preferred stockholders exercised their conversion right, and we issued to the Nuelle preferred stockholders an aggregate of 125,000 shares of our common stock.

Nuelle preferred stockholders are entitled to revenue earn-out payments equal to a designated percentage of net sales on tiers of net sales up to $100.0 million, with an average rate for all tiers in the mid-single digit range, and a maximum aggregate payout of $6.9 million. 

7

The first $1.0 million of earn-out payments will be paid in shares of our common stock and all other earn-out payments will be comprised of 60% cash and 40% shares of our common stock. The stock portion of any earn-out will be calculated by dividing each Nuelle stockholder’s portion of the earn-out by the average closing price of our common stock for the 10 trading days prior to the earlier of the date we deliver notice to the Nuelle stockholders of the earn-out or any public disclosure by us of the earn-out being due and payable. 

In addition to the upfront issuance of common stock and revenue earn-out payments, we agreed to make the following one-time payments to the Nuelle stockholders within 90 days of the occurrence of the following events (provided that, the maximum aggregate amount payable under such milestone payments will be $24.0 million):

Upon achieving the first occurrence of Net Sales of $10.0 million over any sequential four calendar quarter period, Aytu will make a one-time payment to the Nuelle security holders of an amount equal to $1.0 million;
Upon achieving the first occurrence of Net Sales of $17.5 million over any sequential four calendar quarter period, Aytu will make a one-time payment to the Nuelle security holders of an amount equal to $1.8 million;
Upon achieving the first occurrence of Net Sales of $25.0 million over any sequential four calendar quarter period, Aytu will make a one-time payment to the Nuelle security holders of an amount equal to $2.5 million;
Upon achieving the first occurrence of Net Sales of $37.5 million over any sequential four calendar quarter period, Aytu will make a one-time payment to the Nuelle security holders of an amount equal to $3.8 million;
Upon achieving the first occurrence of Net Sales of $50.0 million over any sequential four calendar quarter period, Aytu will make a one-time payment to the Nuelle security holders of an amount equal to $5.0 million; and
Upon achieving the first occurrence of Net Sales of $100.0 million over any sequential four calendar quarter period, Aytu will make a one-time payment to the Nuelle security holders of an amount equal to $10.0 million.

In the event that we do not make all of the required earn-out payments to the Nuelle stockholders before May 3, 2022, and we also complete a divestiture before May 3, 2022 of any of the products acquired in the transaction, we agreed to pay the Nuelle stockholders a combination of (i) cash in an amount equal to 10% of the value of all cash, securities and other property paid to us in the divestiture (cash is to be 60% of the total consideration), and (ii) shares of our common stock equal to the Nuelle stockholders’ portion of the divestiture payment divided by the average closing price of our common stock for the 10 trading days prior to the earlier of the closing date of the divestiture or the public disclosure of the divestiture (shares of common stock are to be 40% of the total consideration)2021.

 

The Company’s allocationAdoption of consideration transferred for Nuelle as of the purchase date May 5, 2017 is as follows:

  Fair Value 
    
Tangible assets $2,061,000 
Intangible assets  1,540,000 
Goodwill  238,000 
Total assets acquired $3,839,000 

Included in the intangible assets is developed technology of $1.3 million, customer contracts of $80,000 and trade names of $160,000, each of which will be amortized over a nine to twelve-year period. Amortization expense of $36,000 and $0 was recognized for the three months ended December 31, 2017 and 2016, respectively. Amortization expense of $74,000 and $0 was recognized for the six months ended December 31, 2017 and 2016, respectively.New Accounting Pronouncements

 

Upon the closing of the merger, we assumed liabilities of $47,000.

The contingent consideration was valued at $1.9 million using a Monte Carlo simulation, as of May 2017. The contingent consideration accretion expense for the three months ended December 31, 2017 and 2016 was $21,000, and $0, respectively. The contingent consideration accretion expense for the six months ended December 31, 2017 and 2016 was $41,000, and $0, respectively.

During the quarter ended September 30, 2017, we paid the first revenue earn-out payment to Nuelle shareholders of $12,000 issued in Aytu common stock, which represented the revenue earn-out payment for fiscal 2017.

During the quarter ended December 31, 2017, we made a $238,000 prepayment, issued in Aytu common stock, which represented the revenue earn-out payment for fiscal 2018.

8

Recently Issued Accounting Pronouncements, Not Adopted as of December 31, 2017

Fair Value Measurements (ASU 2018-13).In May 2014,August 2018, the FASB issued ASU 2014-09, Topic 606, Revenue from Contracts with Customers (the “New Revenue Standard”).2018-13, “Fair Value Measurement (Topic 820) Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement.” The amendments in this ASU provide a single model for use in accounting for revenue arising from contracts with customers and supersedes current revenue recognition guidance, including industry-specific revenue guidance. The core principle of the new ASU isstandard apply to all entities that revenue should be recognizedare required, under existing GAAP, to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods and services. Newmake disclosures about the nature, amount, timingrecurring or nonrecurring fair value measurements. ASU 2018-13 removes, modifies, and uncertainty of revenue and cash flows arising from contracts with customers are also required. In August 2015, the FASB issued ASU 2015-14 which deferred the effective date of the New Revenue Standard. In 2016, the FASB issued ASU 2016-08, ASU 2016-10, ASU 2016-11, and ASU 2016-12 to clarify, among other things, the implementation guidance related to principal versus agent considerations, identifying performance obligations, and accounting for licenses of intellectual property.adds certain disclosure requirements in ASC 820, Fair Value Measurement. The New Revenue Standardstandard is effective for all entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2017, including interim periods within those fiscal years. Early adoption is permitted. The amendments in this update are to be applied on a retrospective basis, either to each prior reporting period presented or by presenting the cumulative effect of applying the update recognized at the date of initial application. We will adopt this standard on July 1, 2018, using the modified retrospective method. The Company has begun its evaluation and assessment to determine the effect of adoption on our existing revenue arrangements. We are also currently evaluating the potential changes to our current policies and processes to ensure we are able to meet the incremental disclosure requirements of the new standard.2019.

 

In May 2017,The amendments on changes in unrealized gains and losses, the FASB issued ASU No. 2017-09, “Compensation-Stock Compensation (Topic 718) Scoperange and weighted average of Modification Accounting (ASU 2017-09).” ASU 2017-09 clarifies which changessignificant unobservable inputs used to the terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718. The standard is effective for interim and annual reporting periods beginning after December 15, 2017, with early adoption permitted. The Company is currently evaluating the impact of its adoption of this standard on its consolidated financial statements.

In January 2017, the FASB issued ASU 2017-04, “Intangibles - Goodwill and Other (Topic 350).” The amendment simplifies the subsequent measurement of goodwill by removing the second step of the two-step impairment test. The amendment requires an entity to perform its annual, or interim goodwill impairment test by comparing thedevelop Level 3 fair value measurements, and the narrative description of a reporting unit with its carrying amount. An impairment charge should be recognized for the amount by which the carrying amount exceeds the reporting unit’s fair value; however, the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. An entity still has the option to perform the qualitative assessment for a reporting unit to determine if the quantitative impairment test is necessary. The amendmentmeasurement uncertainty should be applied on a prospective basis. ASU 2017-04 is effectiveprospectively for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. Early adoption is permitted foronly the most recent interim or annual goodwill impairment tests performed on testing dates after January 1, 2017.period presented in the initial fiscal year of adoption. All other amendments should be applied retrospectively to all periods presented upon their effective date. The Company does not believe that adoptionadopted this as of this amendment will haveJuly 1, 2020, the beginning of the Company’s fiscal year-ended June 30, 2021. The most relevant component of ASU 2018-13 to the Company’s financial statements relates to the need to disclose the range and weighted-average of significant unobservable inputs used in Level 3 fair value measurements. However, the Company discloses on a material impact on its consolidated financial statements.discrete basis all significant inputs for all Level 3 Fair Value measurements.

 

In January 2017, the FASB issued ASU 2017-01, “Business Combinations (Topic 805) Clarifying the Definition of a Business.” The amendment clarifies the definition of a business, which is fundamental in the determination of whether transactions should be accounted for as acquisitions (or disposals) of assets or businesses. This determination is important given the diverging accounting models used for each type of transaction. The guidance is generally expected to result in fewer transactions qualifying as business combinations. The amendment is effective prospectively for public business entities for annual periods beginning after December 15, 2017, including interim periods within those periods. Early adoption is permitted. The Company does not expect an immediate impact from this codification however, if Aytu seeks to purchase additional assets in the future it could have an impact if that purchase is accounted for as a business combination or an asset purchase.Recent Accounting Pronouncements

 

Financial Instruments Credit Losses (ASU 2016-13).In June 2016, the FASB issued ASU 2016-13, “Financial Instruments – Credit Losses” to require the measurement of expected credit losses for financial instruments held at the reporting date based on historical experience, current conditions and reasonable forecasts. The main objective of this ASU is to provide financial statement users with more decision-useful information about the expected credit losses on financial instruments and other commitments to extend credit held by a reporting entity at each reporting date. This ASU isThe standard was effective for private companiesinterim and emerging growth companiesannual reporting periods beginning after December 15, 2020;2019. However, in October 2019, the ASU allows for early adoption asFASB approved deferral of the beginning of an interim or annualadoption date for smaller reporting periodcompanies for fiscal periods beginning after December 15, 2018.2022. Accordingly, the Company’s fiscal year of adoption will be the fiscal year ended June 30, 2024. Early adoption is permitted for interim and annual reporting periods beginning after December 15, 2018, but the Company did not elect to early adopt. The Company is currently assessing the impact that ASU 2016-13 will have on its consolidated financial statements, but no conclusion has been reached.

This Quarterly Report on Form 10-Q does not anticipate therediscuss recent pronouncements that are not anticipated to behave an impact on or are unrelated to the Company’s financial condition, results of operations, cash flows or disclosures.

2. Acquisitions

The Pediatric Portfolio

On October 10, 2019, the Company entered into the Purchase Agreement with Cerecor, Inc. (“Cerecor”) to acquire a material impact.line of prescription pediatric products, (the "Pediatric Portfolio"), which closed on November 1, 2019. At closing, the Pediatric Portfolio consisted of four main prescription products (i) Cefaclor™ for Oral Suspension, (ii) Karbinal® ER (iii) Poly-Vi-Flor®, and (iv) Tri-Vi-Flor™. Total consideration transferred to Cerecor consisted of $4.5 million cash and approximately 980,000 shares of Series G Convertible Preferred Stock. The Company also assumed certain of Cerecor’s financial and royalty obligations, and not more than $2.7 million of Medicaid rebates and up to $0.8 million of product returns, of which all $3.5 million has been incurred. The Company also hired the majority of Cerecor’s commercial workforce.

In addition, the Company assumed Cerecor obligations due to an investor that include fixed and variable payments aggregating to $25.6 million. The Company assumed fixed monthly payments equal to $0.1 million from November 2019 through January 2021 plus $15.0 million due in January 2021. Monthly variable payments due to the same investor are equal to 15% of net revenue generated from a subset of the Pediatric Portfolio, subject to an aggregate monthly minimum of $0.1 million, except for January 2020, when a one-time payment of $0.2 million was paid to the investor. The variable payment obligation continues until the earlier of: (i) aggregate variable payments of approximately $9.5 million have been made, or (ii) February 12, 2026. In June 2020, the Company paid down a $15.0 million balloon payment originally owed in January 2021 to reduce the fixed liability.

Further, certain of the products in the Pediatric Portfolio require royalty payments ranging from 12% to 15% of net revenue. One of the products in the Product Portfolio requires the Company to generate minimum annual sales sufficient to represent annual royalties of approximately $2.1 million, in the event the minimum sales volume is not satisfied.

 

While no equity was acquired by the Company, the transaction was accounted for as a business combination under the acquisition method of accounting pursuant to Topic 805. Accordingly, the tangible and identifiable intangible assets acquired, and liabilities assumed were recorded at fair value as of the date of acquisition, with the remainder of the aggregate purchase price recorded as goodwill. The goodwill recognized is attributable primarily to strategic opportunities related to an expanded commercial footprint and diversified product portfolio that is expected to provide revenue and cost synergies.

The following table summarized the fair value of assets acquired and liabilities assumed at the date of acquisition. 

  

As of

 
  

November 1, 2019

 

Consideration

    

Cash and cash equivalents

 $4,500,000 

Fair value of Series G Convertible Preferred Stock

    

Total shares issued

  9,805,845 

Estimated fair value per share of Aytu common stock

 $0.567 

Estimated fair value of equity consideration transferred

  5,559,914 

Total consideration transferred

 $10,059,914 

Recognized amounts of identifiable assets acquired and liabilities assumed

    

Inventory

 $459,123 

Prepaid assets

  1,743,555 

Other current assets

  2,525,886 

Intangible assets - product marketing rights

  22,700,000 

Accrued liabilities

  (300,000)

Accrued product program liabilities

  (6,683,932)

Assumed fixed payment obligations

 $(29,837,853)

Total identifiable net assets

  (9,393,221)

Goodwill

 $19,453,135 

The fair values of intangible assets, including product technology rights were determined using variations of the income approach. Varying discount rates were also applied to the projected net cash flows. The Company believes the assumptions are representative of those a market participant would use in estimating fair value.

The fair value of the net identifiable asset acquired was determined to be $22.7 million, which is being amortized over ten years.

Innovus Merger (Consumer Health Portfolio)

On February 14, 2020, the Company completed the merger with Innovus Pharmaceuticals after approval by the stockholders of both companies on February 13, 2020 (the "Innovus Merger"). Upon the effectiveness of the Innovus Merger, a subsidiary of the Company merged with and into Innovus, and all outstanding Innovus common stock was exchanged for approximately 380,000 shares of the Company’s common stock and up to $16.0 million of Contingent Value Rights (“CVRs”). The outstanding Innovus warrants with 'cash out' rights were exchanged for approximately 200,000 shares of Series H Convertible Preferred stock of the Company over a period of time covering February 26, 2020 through March 10, 2020. The remaining Innovus warrants outstanding, those without ‘cash out’ rights, at the time of the Innovus Merger, continue to be outstanding, and upon exercise, retain the right to the merger consideration offered to Innovus stockholders, including any remaining claims represented by CVRs at the time of exercise. Innovus is now a 100% wholly-owned subsidiary of the Company, (“Aytu Consumer Health”).

On March 31, 2020, the Company paid out the first CVR Milestone in the form of approximately 120,000 shares of the Company’s common stock to satisfy the $2.0 million obligation as a result of Innovus achieving the $24 million revenue milestone for the calendar year ended December 31, 2019. As a result of this, the Company recognized a gain of approximately $0.3 million during the three months ended March 31, 2020. On March 20, 2021, the Company paid the CVR holders approximately 103,000 shares of the Company’s common stock to satisfy one of two $1.0 million 2020 milestones, which relates to the Innovus achievement of $30.0 million in revenues during the 2020 calendar year. As a result of this, the Company recognized a gain of approximately $0.4 million during the three months ended March 31, 2021. The $1.0 million 2020 milestone for the Aytu Consumer Health subsidiary achieving profitability was not met.

In addition, as part of the Innovus Merger, the Company assumed approximately $3.1 million of notes payable, $0.8 million in lease liabilities, and other assumed liabilities associated with Innovus. Of the $3.1 million of notes payable, approximately $2.2 million was converted into approximately 180,000 shares of the Company’s common stock since February 14, 2020. Approximately $41,000 remained outstanding as of March 31, 2021.

The following table summarized the fair value of assets acquired and liabilities assumed at the date of acquisition. These estimates are preliminary, pending final evaluation of certain assets and liabilities, and therefore, are subject to revisions that may result in adjustments to the values presented below:

  

As of

 
  

February 14, 2020

 

Consideration

    

Fair Value of Aytu Common Stock

    

Total shares issued at close

  3,810,393 

Estimated fair value per share of Aytu common stock

 $0.756 

Estimated fair value of equity consideration transferred

 $2,880,581 

Fair value of Series H Convertible Preferred Stock

    

Total shares issued

  1,997,736 

Estimated fair value per share of Aytu common stock

 $0.756 

Estimated fair value of equity consideration transferred

 $1,510,288 

Fair value of former Innovus warrants

 $15,315 

Fair value of Contingent Value Rights

  7,049,079 

Forgiveness of Note Payable owed to the Company

  1,350,000 

Total consideration transferred

 $12,805,263 

  

As of

 
  

February 14, 2020

 

Total consideration transferred

 $12,805,263 

Recognized amounts of identified assets acquired and liabilities assumed

    

Cash and cash equivalents

 $390,916 

Accounts receivable

  278,826 

Inventory

  1,149,625 

Prepaid expenses and other current assets

  1,692,133 

Other long-term assets

  36,781 

Right-to-use assets

  328,410 

Property, plant and equipment

  190,393 

Trademarks and patents

  11,744,000 

Accounts payable and accrued other expenses

  (7,202,309)

Other current liabilities

  (629,601)

Notes payable

  (3,056,361)

Lease liability

  (754,822)

Total identifiable net assets

 $4,167,991 

Goodwill

 $8,637,272 

The fair values of intangible assets, including product distribution rights were determined using variations of the income approach, specifically the relief-from-royalties method. It also includes customer lists using an income approach utilizing a discounted cash flow model. Varying discount rates were also applied to the projected net cash flows. The CVRs were valued using a Monte-Carlo model. The Company believes the assumptions are representative of those a market participant would use in estimating fair value (see Note 9).

The fair value of the net identifiable assets acquired was determined to be $11.7 million, which is being amortized over a range between 1.5 to 10 years.

Neos Merger (ADHD Portfolio)

On March 19, 2021, the Company completed the Neos Merger with Neos Therapeutics, Inc. after approval by the stockholders of Neos on March 18, 2021 and the approval of the consideration to be delivered by the Company in connection with the merger by the shareholders of Aytu, also on March 18, 2021. Upon the effectiveness of the Neos Merger, a subsidiary of the Company merged with and into Neos, and all outstanding Neos common stock was exchanged for approximately 5,472,000 shares of the Company’s common stock. Neos is now a 100% wholly-owned subsidiary of the Company. The Company pursued the acquisition of Neos in order to gain scale in the industry, expand its product portfolio and as an opportunity to potentially accelerate the pathway to breakeven. The Company incurred in relation to the Neos Merger (i) approximately $2.8 million of acquisition related costs, recognized as part of operating expense, and (ii) $0.1 million of issuance costs, recognized as a component of stockholders’ equity. 

The following table summarized the preliminary fair value of assets acquired and liabilities assumed at the date of acquisition. These estimates are preliminary, pending final evaluation of certain assets and liabilities, and therefore, are subject to revisions that may result in adjustments to the values presented below;

  

As of

 
  

March 19, 2021

 

Considerations:

    

Fair Value of Aytu Common Stock

    

Total shares issued at close

  5,471,804 

Estimated fair value per share of Aytu common stock

 $9.73 

Estimated fair value of equity consideration transferred

 $53,240,653 

Cash

  15,383,104 
Estimated fair value of replacement equity awards  432,289 

Total consideration transferred

 $69,056,046 

  

As of

 
  

March 19, 2021

 

Total consideration transferred

 $69,056,046 

Recognized amounts of identified assets acquired and liabilities assumed

    

Cash and cash equivalents

 $15,721,797 

Accounts receivable

  24,695,527 

Inventory

  10,984,055 

Prepaid expenses and other current assets

  2,929,457 

Operating leases right-to-use assets

  3,515,141 

Property, plant and equipment

  5,518,801 

Intangible assets

  56,530,000 

Other long-term assets

  148,931 

Accounts payable and accrued expenses

  (56,718,159)

Short-term line of credit

  (10,707,115)

Long-term debt, including current portion

  (17,677,954)

Operating lease liabilities

  (3,515,141)

Other long-term liabilities

  (81,523)

Total identifiable net assets

 $31,343,817 

Goodwill

 $37,712,229 

The fair values of intangible assets were determined using variations of the cost approach, excess earnings method and the relief-from-royalties method. The fair value of Neos trade name, in-process R&D and developed product technology, which is the proprietary technology for the development of Adzenys, Cotempla and generic Tussionex, were determined using the relief from royalty method. The fair value of developed technology right, which is a proprietary modified-release drug delivery technology, was determined using multi-period excess earnings method. The fair value of RxConnect, which is a developed technology for Neos-sponsored patient support program that offers affordable and predictable copays to all commercially insured patients, was determined using cost to recreate method. The finite-lived intangible assets are being amortized over a range of between 1 to 18 years.

The fair value of the identifiable intangible assets acquired were as follows:

  

As of

 
  

March 19, 2021

 

Identified intangible assets acquired:

    

Developed technology right

 $30,200,000 

Developed products technology

  22,700,000 

In-process R&D

  2,600,000 

RxConnect

  630,000 

Trade name

  400,000 

Total intangible assets acquired

 $56,530,000 

Unaudited Pro Forma Information

The following supplemental unaudited proforma financial information presents the Company’s results as if the following acquisitions had occurred on July 1, 2019:

 9

Acquisition of the Pediatric Portfolio, effective November 1, 2019;

 

Merger with Innovus, effective February 14, 2020.

Merger with Neos, effective March 19, 2021.

The unaudited pro forma results have been prepared based on estimates and assumptions, which management believes are reasonable, however, the results are not necessarily indicative of the consolidated results of operations had the acquisition occurred on July 1, 2019, or of future results of operations:

  

Three Months Ended

  

Nine Months Ended

 
  

March 31, 2021

  

March 31, 2020

  

March 31, 2021

  

March 31, 2020

 
  

Actual

  

Pro forma

  

Actual

  

Pro forma

 
  

(Unaudited) (dd)

  

(Unaudited) (aa) (bb)

  

(Unaudited) (dd)

  

(Unaudited) (cc)

 

Total revenues, net

 $22,250,543  $24,824,477  $74,582,036  $83,141,373 

Net (loss)

 $(32,674,710) $(13,800,554) $(55,711,884) $(31,686,745)

Net (loss) per share (ee)

 $(1.41) $(3.91) $(2.71) $(14.01)

(aa) For the three months ended March 31, 2020, the Pediatric Portfolio acquisition occurred prior to the three months ended March 31, 2020, and accordingly, the results of the Pediatric Portfolio are fully consolidated into the Company’s results for the three months ended March 31, 2020.

(bb) Due to the absence of discrete financial information for Innovus covering the period from January 1, 2020 through February 13, 2020, the Company did not include the impact of that stub-period for the pro forma results for the three and nine months ended March 31, 2020.

(cc) Due to a lack of financial information covering the period from October 1, 2019 through November 1, 2019, the Company was not able to provide pro forma adjusted financial statements for the nine months ended March 31, 2020 without making estimated extrapolations that the Company did not believe would be material or useful to users of the above pro forma information.

(dd) Neos contributed approximately $0.9 million to net revenue and approximately $3.9 million to net loss for the period covering March 20, 2021 through March 31, 2021.

(ee) Pro forma net loss per share calculations excluded the impact of the issuance of the (i) Series G Convertible Preferred Stock and the, (ii) Series H Convertible Preferred Stock under the assumption those shares would continue to remain non-participatory during the periods reported above.

 

 

3. Revenue Recognition

Contract Balances. Contract assets primarily relate to the Company’s right to consideration in exchange for products transferred to a customer in which that right to consideration is dependent upon the customer selling these products. As of March 31, 2021, contract assets of $42,000 was included in other current assets in the consolidated balance sheet. There was no contract asset as of June 30, 2020. Contract liabilities primarily relate to advances or deposits received from the Company's customers before revenue is recognized. As of March 31, 2021 and June 30, 2020, contract liabilities of $0.2 million and $0.3 million, respectively, were included in accrued liabilities in the consolidated balance sheet.

Revenues by Geographic location. The following table reflects the Company's product revenues by geographic location as determined by the billing address of customers:

  

Three Months Ended

  

Nine Months Ended

 
  

March 31,

  

March 31,

 
  

2021

  

2020

  

2021

  

2020

 
             

U.S.

 $12,344,000  $7,273,000  $38,245,000  $11,582,000 

International

  1,138,000   883,000   3,905,000   1,189,000 

Total net revenue

 $13,482,000  $8,156,000  $42,150,000  $12,771,000 

Revenues by Product Portfolio. Net revenue disaggregated by significant product portfolio for the three and nine months ended March 31, 2021 and March 31, 2020 were as follows:

  

Three Months Ended March 31,

  

Nine Months Ended March 31,

 
  

2021

  

2020

  

2021

  

2020

 
                 

Primary care and devices portfolio

 $1,209,000  $870,000  $8,339,000  $3,500,000 

Pediatric portfolio

  3,918,000   3,833,000   9,752,000   5,818,000 

Consumer Health portfolio

  8,355,000   3,453,000   24,059,000   3,453,000 

Consolidated revenue

 $13,482,000  $8,156,000  $42,150,000  $12,771,000 

4. Inventories

Inventories consist of raw materials, work in process and finished goods and are recorded at the lower of cost or net realizable value, with cost determined on a first-in, first-out basis. Aytu periodically reviews the composition of its inventories to identify obsolete, slow-moving or otherwise unsaleable items. In February 2016, the FASB issued ASU 2016-02, “Leases (Topic 842).” The new standard establishes a right-of-use (ROU) modelevent that requires a lessee tosuch items are identified and there are no alternate uses for the inventory, Aytu will record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognitionwrite-down to net realizable value in the income statement.period that the impairment is first recognized. The new standard is effectiveCompany wrote down $7.0 million and $7.2 million of inventory during the three and nine months ended March 31, 2021, respectively, primarily as a result of changing market conditions for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. A modified retrospective transition approach is requiredthe Company's COVID-19 test kits. There was no inventory written down for leases for capitalthe three and operating leases existing at, or entered into after, the beginningnine-months ended March 31, 2020, respectively.

Inventory balances consist of the earliest comparative period presented in the financial statements, with certain practical expedients available. The Company is currently evaluating the impact of its adoption of this standard on its consolidated financial statements. following:

 

  

As of

  

As of

 
  

March 31,

  

June 30,

 
  

2021

  

2020

 

Raw materials

 $2,583,000  $397,000 
Work in process  3,181,000    

Finished goods

  10,812,000   9,603,000 
Inventory $16,576,000  $10,000,000 

Note 2 –

5. Fixed Assets

 

Fixed assets are recorded at cost and once placed in service, are depreciated on a straight-line basis over the estimated useful lives. Leasehold improvements are amortized over the shorter of the estimated economic life or related lease term. Fixed assets consist of the following:

 

 Estimated
Useful Lives
 As of
December 31,
 As of
June 30,
     

As of

  

As of

 
 in years 2017 2017  

Estimated

  

March 31,

  

June 30,

 
      

Useful Lives in years

  

2021

  

2020

 
Manufacturing equipment 2 - 5 $423,000  $405,000  2 - 7  $3,072,000  $112,000 
Leasehold improvements 3  111,000   111,000  3   1,259,000   229,000 
Office equipment, furniture and other 2 - 5  344,000   287,000  2 - 7   966,000   312,000 
Lab equipment 3 - 5  90,000   90,000  3 - 7   646,000   90,000 
Assets under construction     186,000    
Less accumulated depreciation and amortization  (407,000)  (246,000)     (571,000)  (484,000)
Fixed assets, net $561,000  $647,000     $5,558,000  $259,000 

During the nine months ended March 31, 2021, the Company recognized a loss of $0.1 million on sale of equipment due to termination of leases. There was no such loss during the three months ended March 31, 2021.

        Depreciation and amortization expense totaled $68,000 and $24,000 for the three-months ended March 31, 2021 and 2020, respectively, and $119,000 and $56,000 for the nine-months ended March 31, 2021 and 2020, respectively.

6. Leases, Right-to-Use Assets and Related Liabilities

 

The depreciationCompany previously adopted the FASB issued ASU 2016-02, “Leases (Topic 842)” as of July 1, 2019. With the adoption of ASU 2016-02, the Company recorded an operating right-of-use asset ("ROU") and amortizationan operating lease liability on its balance sheet associated with the leases of the corporate headquarters. The finance leases are related to the Company's Neos subsidiary equipment leases. The operating lease ROU asset represents the Company’s right to use the underlying asset for the lease term, and the lease obligation represents the Company’s commitment to make the lease payments arising from the lease. The operating lease ROU assets and obligations were recognized at the later of the commencement date or July 1, 2019, the date of adoption of Topic 842, based on the present value of remaining lease payments over the lease term. As the Company’s lease does not provide an implicit rate, the Company used an estimated incremental borrowing rate based on the information available at the commencement date in determining the present value of the lease payments. Rent expense is recognized on a straight-line basis over the lease term, subject to any changes in the lease or expectations regarding the terms. The operating lease liabilities are classified as current or long-term operating lease liabilities on the balance sheet.

Upon the closing of the Neos Merger on March 19, 2021, pursuant to the guidance under ASC 805, Neos recognized operating lease ROU asset and lease liability of $3.5 million, which represented the present value of the remaining lease payments as of the acquisition date, for its office space and manufacturing facilities at Grand Prairie, Texas. As the lease agreement does not provide an implicit rate, Neos used its borrowing rate of 6.7% to determine the present value of future lease payments. Furthermore, as of the acquisition date, no assets or liabilities of the operating leases that have a remaining lease term of less than twelve months were recognized. The finance leases are related to Neos equipment finance leases with fixed contract terms and an implicit interest rate of approximately 5.9%. The finance lease assets are included in fixed assets and the lease liabilities are included in current and long-term debt on the balance sheet.

On August 28, 2020, the Company’s Innovus subsidiary signed a lease termination agreement with its lessor to terminate its lease effective September 30, 2020. The original lease termination date was April 30, 2023. As part of the agreement, Innovus agreed to make a cash payment to the landlord the equivalent of two additional months’ rent aggregating to $44,306 plus $125,000 less the security deposit of $20,881. The fair value of the lease liability related to this facility lease was approximately $0.7 million as of June 30, 2020. The Company recognized a gain of approximately $343,000 during the nine months ended March 31, 2021.

       On October 1, 2020, the Company's Innovus subsidiary entered into a short-term lease for warehouse space in Carlsbad, CA. The lease term is for one-year with an option to terminate after six months with ninety days' notice. This lease is accounted for as a short-term lease and is not included as a component of the Company's right-to-use assets and related liability.

The components of lease expenses are as follows:

 

  Three Months Ended
December 31,
  Six Months Ended
December 31,
 
  2017  2016  2017  2016 
                 
Depreciation and amortization expense $81,000  $26,000  $161,000  $45,000 
  

Three Months Ended

  

Nine Months Ended

  
  

March 31,

  

March 31,

  
  

2021

  

2020

  

2021

  

2020

 

Statement of Operations Classification

Lease cost:

                 

Operating lease cost

 $69,000  $27,000  $128,000  $72,000 

Operating expenses

Short-term lease cost  7,000      7,000    Operating expenses

Finance lease cost:

                 
Amortization of leased assets  19,000      19,000    Cost of sales
Interest on lease liabilities  1,000      1,000    Other (expense), net

Total net lease cost

 $96,000  $27,000  $155,000  $72,000  

 

Note 3 – Patents

Supplemental balance sheet information related to leases is as follows:

  

March 31, 2021

  

June 30, 2020

 

Balance Sheet Classification

Assets:

         
Operating lease assets $3,782,000  $634,000 Operating lease right-of-use asset
Finance lease assets  347,000    Fixed assets, net

Total leased assets

 $4,129,000  $634,000  

Liabilities:

         

Current:

         

Operating leases

 $911,000  $300,000 

Current portion of operating lease liabilities

Finance leases

  100,000    

Current portion of debt

Long-term

         

Operating leases

  2,872,000   725,000 

Long-term operating lease liabilities, net of current portion

Finance leases

  207,000   - 

Long-term debt, net of current portion

Total lease liabilities

 $4,090,000  $1,025,000  

Remaining lease term and discount rate used are as follows:

  

March 31, 2021

  

June 30, 2020

 

Weighted-Average Remaining Lease Term (years)

        

Operating lease assets

  3.67   3.33 

Finance lease assets

  2.96    

Weighted-Average Discount Rate

        

Operating lease assets

  6.62%  8.09%

Finance lease assets

  6.40%   

Supplemental cash flow information related to lease is as follows:

  

Nine Months Ended

 
  

March 31,

 
  

2021

  

2020

 

Cash flow classification of lease payments:

        

Operating cash flows from operating leases

 $128,000  $72,000 

Operating cash flows from finance leases

 $1,000  $- 

As of March 31, 2021, the maturities of the Company’s future minimum lease payments were as follows:

  

Operating

  

Finance

 

2021 (remaining 3 months)

 $281,000  $29,000 

2022

  1,154,000   117,000 

2023

  1,182,000   105,000 

2024

  1,117,000   88,000 

2025

  557,000    

Total lease payments

  4,291,000   339,000 
Less: Imputed interest  (508,000)  (32,000)
Lease liabilities $3,783,000  $307,000 

7. Intangible Assets

 

The Company currently holds the following intangible asset portfolios as of March 31, 2021: (i) Licensed assets, which consist of pharmaceutical product assets that were acquired prior to July 1, 2020; (ii) Product technology rights, acquired from the November 1, 2019 acquisition of the Pediatric Portfolio from Cerecor, as a result of the Innovus Merger on February 14, 2020 and as a result of the Neos Merger on March 19, 2021, (iii) Proprietary modified-release drug delivery technology right as a result of the Neos Merger, (iv) Acquired product distribution rights and commercial technology consisting of RxConnect and trade names as a result of the Neos Merger, and patents, trade names and the acquired customer lists from the Innovus Merger, (v) Acquired in-process R&D related to NT0502 product candidate for sialorrhea from the Neos Merger.

On March 31, 2021, the Company and Acerus Pharmaceuticals Corporation (“Acerus”) entered into a termination and transition agreement (the “Termination Agreement”) to terminate the License and Supply Agreement previously entered into on July 29, 2019. Pursuant to the Termination Agreement, the Company ceased all sales, marketing and promotions of Natesto, and Acerus agreed to pay the Company an aggregate amount of $7.5 million, payable in equal monthly installment payments for a period of 30 consecutive months. The Company determined that none of the $7.5 million future cash payments can be recognized as of March 31, 2021, and therefore the remaining $4.3 million carrying value of the licensed intangible asset related to Natesto was impaired, and there is no remaining value as of March 31, 2021. 

If acquired in an asset acquisition, the Company capitalized the acquisition cost of each licensed patent or tradename, which can include a combination of both upfront consideration, as well as the Luoxis patents were $380,000estimated future contingent consideration estimated at the acquisition date. If acquired in a business combination, the Company capitalizes the estimated fair value of the intangible asset or assets acquired, based primarily on a discounted cash flow model approach or relief-from-royalties model as further described in Note 2.

The following table provides the summary of the Company’s intangible assets as of March 31, 2021 and June 30, 2020, respectively.

  

March 31, 2021

 
  

Gross Carrying Amount

  

Accumulated Amortization

  

Impairment

  

Net Carrying Amount

  Weighted-Average Remaining Life (in years) 

Licensed assets

 $23,649,000  $(8,768,000) $(4,286,000) $10,595,000   15.15 

Acquired product technology right

  45,400,000   (3,259,000)     42,141,000   13.37 
Acquired technology right  30,200,000   (57,000)     30,143,000   16.97 

Acquired product distribution rights

  11,354,000   (1,697,000)     9,657,000   7.03 
Acquired in-process R&D  2,600,000   -      2,600,000   Indefinite-lived 
Acquired commercial technology  630,000   (20,000)     610,000   1.97 
Acquired trade name  400,000   (6,000)     394,000   0.97 

Acquired customer lists

  390,000   (293,000)     97,000   0.37 
Total $114,623,000  $(14,100,000) $(4,286,000) $96,237,000   13.56 

  

June 30, 2020

 
  

Gross Carrying Amount

  

Accumulated Amortization

  

Impairment

  

Net Carrying Amount

  Weighted-Average Remaining Life (in years) 

Licensed assets

 $23,649,000  $(7,062,000) $  $16,587,000   11.88 

MiOXSYS Patent

  380,000   (185,000)  (195,000)      

Acquired product technology right

  22,700,000   (1,513,000)     21,187,000   9.34 

Acquired product distribution rights

  11,354,000   (565,000)     10,789,000   7.78 

Acquired customer lists

  390,000   (98,000)     292,000   1.12 
Total $58,473,000  $(9,423,000) $(195,000) $48,855,000   9.11 

The following table summarizes the estimated future amortization expense to be recognized over the next five years and periods thereafter:

  

Amortization

 

2021 (remaining 3 months)

 $2,234,500 

2022

  8,529,000 

2023

  7,981,000 

2024

  7,825,000 

2025

  7,591,000 

Thereafter

  59,476,500 
Total future amortization expense $93,637,000 

Certain of the Company’s amortizable intangible assets include renewal options, extending the expected life of the asset. The renewal periods range between approximately 1 to 20 years depending on the license, patent or other agreement. Renewals are accounted for when they were acquired in connection withare reasonably assured. Intangible assets are amortized using the 2013 formation of Luoxis and are being amortizedstraight-line method over the remaining U.S. patent livesestimated useful lives. Amortization expense of approximately 15 years, which expires in intangible assets was $1.7 million and $1.4 million for the three months ended March 2028. Patents31, 2021 and 2020, respectively. Amortization expense of intangible assets was $4.9 million and $2.9 million for the nine months ended March 31, 2021 and 2020, respectively.

8. Accrued liabilities

Accrued liabilities consist of the following:

 

  As of
December 31,
  As of
June 30,
 
  2017  2017 
       
Patents $380,000  $380,000 
Less accumulated amortization  (121,000)  (109,000)
Patents, net $259,000  $271,000 
  

As of

  

As of

 
  

March 31,

  

June 30,

 
  

2021

  

2020

 

Accrued settlement expense

 $150,000  $315,000 

Accrued program liabilities

  7,836,000   959,000 

Accrued product-related fees

  2,379,000   2,471,000 
Accrued savings offers  19,218,000    
Accrued distributor fees  2,816,000   457,000 

Credit card liabilities

  657,000   510,000 

Medicaid liabilities

  1,948,000   1,842,000 

Return reserve

  5,592,000   1,329,000 

Sales taxes payable

  182,000   175,000 

Other accrued liabilities*

  2,404,000   588,000 

Total accrued liabilities

 $43,182,000  $8,646,000 

 

10

* Other accrued liabilities consist of franchise tax, accounting and legal fees, interest payable, merchant services charges, none of which individually represent greater than five percent of total current liabilities.

 

The amortization expense was as follows:

  Three Months Ended
December 31,
  Six Months Ended
December 31,
 
  2017  2016  2017  2016 
                 
Amortization expense $6,000  $6,000  $12,000  $13,000 

Note 4 – Income Taxes

On December 22, 2017, the U.S. Tax Cuts and Jobs Act (the “Tax Reform Act”) was signed into law by the President of the United States. The Tax Reform Act significantly revised the U.S. corporate income tax regime by, among other things, lowering the U.S. corporate tax rate from 35% to 21% effective January 1, 2018. GAAP requires that the impact of tax legislation be recognized in the period in which the law was enacted. As a result of the Tax Reform Act, the Company recorded a tax expense of $6.6 million due to a re-measurement of deferred tax assets and liabilities at a blended rate in the three months ended December 31, 2017, which is fully offset by a reduction in valuation allowance. The tax expense is a provisional amount and the Company’s current best estimate. Any adjustments recorded to the provisional amounts will be included in income from operations as an adjustment to tax expense, net of any related valuation allowance. The provisional amount incorporates assumptions made based upon the Company’s current interpretation of the Tax Reform Act and may change as the Company receives additional clarification and implementation guidance.

Note 5 –9. Fair Value Considerations

 

Aytu’sThe Company’s asset and liability classified financial instruments include cash and cash equivalents, restricted cash, accounts receivable, accounts payable, accrued liabilities, and warrant derivative liability.liability and contingent consideration. The carrying amounts of financial instruments, including cash and cash equivalents, restricted cash, accounts receivable, accounts payable and other current assets and otheraccrued liabilities approximate their fair value due to their short maturities. The fair value of acquisition-related contingent consideration is based on estimated discounted future cash flows and periodic assessments of the probability of occurrence of potential future events.Monte-Carlo models. The valuation policies are determined by the Chief Financial Officermanagement, and the Company’s Board of Directors is informed of any policy change.

 

Authoritative guidance defines fair value as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the measurement date. The guidance establishes a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability developed based on market data obtained from sources independent of Aytu.the Company. Unobservable inputs are inputs that reflect Aytu’sthe Company’s assumptions of what market participants would use in pricing the asset or liability developed based on the best information available in the circumstances. The hierarchy is broken down into three levels based on reliability of the inputs as follows:

 

Level 1:Inputs that reflect unadjusted quoted prices in active markets that are accessible to Aytu for identical assets or liabilities;
Level 2:Inputs that include quoted prices for similar assets and liabilities in active or inactive markets or that are observable for the asset or liability either directly or indirectly; and
Level 3:Unobservable inputs that are supported by little or no market activity.

Level 1: Inputs that reflect unadjusted quoted prices in active markets that are accessible to Aytu for identical assets or liabilities;

 

Aytu’sLevel 2: Inputs that include quoted prices for similar assets and liabilities in active or inactive markets or that are observable for the asset or liability either directly or indirectly; and

Level 3: Unobservable inputs that are supported by little or no market activity.

The Company’s assets and liabilities which are measured at fair value are classified in their entirety based on the lowest level of input that is significant to their fair value measurement. Aytu’sThe Company’s policy is to recognize transfers in and/or out of fair value hierarchy as of the date in which the event or change in circumstances caused the transfer. Aytu has consistently applied the valuation techniques discussed below in all periods presented.

 

11

Recurring Fair Value Measurements

 

The following table presents Aytu’sthe Company’s financial liabilities that were accounted for at fair value on a recurring basis as of DecemberMarch 31, 2017,2021 and June 30, 2020, by level within the fair value hierarchy.

 

  Fair Value Measurements Using 
  Level 1  Level 2  Level 3  Total 
December 31, 2017            
LIABILITIES            
Warrant derivative liability $-  $-  $3,300,000  $3,300,000 
Contingent consideration $-  $-  $8,013,000  $8,013,000 
                 
June 30, 2017                
LIABILITIES                
Warrant derivative liability $-  $-  $-  $- 
Contingent consideration $-  $-  $7,648,000  $7,648,000 
      

Fair Value Measurements at March 31, 2021

 
  

Fair Value at March 31, 2021

  

Quoted Priced in Active Markets for Identical Assets (Level 1)

  

Significant Other Observable Inputs (Level 2)

  

Significant Unobservable Inputs (Level 3)

 

Recurring:

                

Contingent consideration

 $14,904,000  $  $  $14,904,000 

CVR liability

  5,591,000         5,591,000 
Total $20,495,000  $  $  $20,495,000 

      

Fair Value Measurements at June 30, 2020

 
  

Fair Value at June 30, 2020

  

Quoted Priced in Active Markets for Identical Assets (Level 1)

  

Significant Other Observable Inputs (Level 2)

  

Significant Unobservable Inputs (Level 3)

 

Recurring:

                

Contingent consideration

 $13,588,000  $  $  $13,588,000 

CVR liability

  5,572,000)        5,572,000)
Total $19,160,000  $  $  $19,160,000 

 

Contingent Consideration.The warrant derivative liability was valued using the lattice valuation methodology because that model embodies the relevant assumptions that address the features underlying these instruments. The warrants related to the warrant derivative liability are not actively traded and are, therefore, classified as Level 3 liabilities. Significant assumptions in valuing the warrant derivative liability, based on estimates of the value of Aytu common stock and various factors regarding the warrants, were as follows as of issuance and as of December 31, 2017:

  December 31,
2017
  At Issuance 
Warrants:      
Volatility  177.1%  188.0%
Equivalent term (years)  4.63   5.00 
Risk-free interest rate  2.16%  1.83%
Dividend yield  0.00%  0.00%

The following table sets forth a reconciliation of changes in the fair value of the derivative financial liabilities classified as Level 3 in the fair value hierarchy:

  Derivative Instruments 
    
Balance as of June 30, 2017 $- 
Warrant issuances  4,118,000 
Change in fair value included in earnings  (818,000)
Balance as of December 31, 2017 $3,300,000 

We classify ourCompany classifies its contingent consideration liability in connection with the acquisition of ProstaScint, NatestoTuzistra XR, ZolpiMist and FieraInnovus, within Level 3 as factors used to develop the estimated fair value are unobservable inputs that are not supported by market activity. We estimateThe Company estimates the fair value of our contingent consideration liability based on projected payment dates, discount rates, probabilities of payment and projected revenues. Projected contingent payment amounts are discounted back to the current period using a discounted cash flow methodology.

As of November 2, 2018, the contingent consideration related to Tuzistra XR, was valued at $8.8 million using a Monte Carlo simulation. As of March 31, 2021, the contingent consideration was revalued at $14.4 million using the same Monte Carlo simulation methodology, and based on current interest rates, expected sales potential and Aytu stock trading variables.  As of March 31, 2021, none of the milestones had been achieved, and therefore, no milestone payment was made. However, approximately $3.0 million is expected to be paid in November 2021, as this milestone will be satisfied.

The contingent consideration related to the ZolpiMist royalty payments was valued at $2.6 million using a Monte Carlo simulation, as of June 11, 2018. As of March 31, 2021, the contingent consideration was revalued at $0.3 million using the same Monte Carlo simulation methodology, and based on current interest rates, expected sales potential and Aytu stock trading variables. The Company reevaluates the contingent consideration on a quarterly basis for changes in the fair value recognized after the acquisition date, such as measurement period adjustments.  As of March 31, 2021, none of the milestones had been achieved, and therefore, no milestone payment was made.

The Company recognized approximately $0.2 million in product related contingent consideration as a result of the February 14, 2020 Innovus Merger. The fair value was based on a discounted value of the future contingent payment using a 30% discount rate based on the estimates risk that the milestones are achieved. The contingent consideration accretion expense for the three and nine months ended March 31, 2021 and 2020 was $15,000, and $44,000, respectively. There was no material change in this valuation as of March 31, 2021.

Contingent value rights. Contingent value rights (“CVRs”) represent contingent additional consideration of up to $16.0 million payable to satisfy future performance milestones related to the Innovus Merger. Consideration can be satisfied in up to 470,000 shares of the Company’s common stock, or cash either upon the option of the Company or in the event there are insufficient shares available to satisfy such obligations. The fair value of the contingent considerationvalue rights was based on a Monte Carlo model which takes into account current interest rates and expected sales potential. On March 31, 2020, the Company paid the CVR holders approximately 120,000 shares of the Company’s common stock to satisfy the first $2.0 million milestone, which relates to the Innovus achievement of $24.0 million in revenues during the period2019 calendar year. On March 20, 2021, the Company paid the CVR holders approximately 103,000 shares of the Company’s common stock to satisfy one of two $1.0 million 2020 milestones, which relates to the Innovus achievement of $30.0 million in revenues during the 2020 calendar year. The $1.0 million 2020 milestone for achieving profitability was not met. The unrealized loss for the three months ended March 31, 2021 and March 31, 2020 was $0.1 million and $0.2 million, respectively. The unrealized loss for the nine months ended months ended March 31, 2021 and 2020 was $1.0 million and $0.2 million, respectively. The CVR's did not exist until after December 31, 2017.2019. 

Summary of Level 3 Input Changes

 

The following table sets forth a summary of changes to those fair value measures using Level 3 inputs for the nine months ended March 31, 2021:

  

CVR Liability

  

Contingent Consideration

 

Balance as of June 30, 2020

 $5,572,000  $13,588,000 

Included in earnings

  1,019,000   1,999,000 

Settlements

  (1,000,000)  (683,000)

Balance as of March 31, 2021

 $5,591,000  $14,904,000 

Significant Assumptions

Contingent consideration. The Company estimates the fair value of the Contingent Consideration at each reporting date using management's forecast as the baseline for developing a Monte-Carlo model.The other significant assumptions used in the contingent consideration for the period ended DecemberMonte Carlo Simulation as of March 31, 2017:2021, were as follows: 

  Contingent Consideration 
    
Balance as of June 30, 2017 $7,648,000 
Increase due to accretion  384,000 
Decrease due to contractual payment  (19,000)
Balance as of December 31, 2017 $8,013,000 

 

 12

As of March 31, 2021

Contingent Consideration

Credit risk assumption

20.80%

Sales volatility

45.00%

Credit spread

3.00%

Time steps per year

1

Number of iterations

500 

Contingent value rights. The Company estimates the fair value of the Contingent Value Rights at each reporting date using management's forecast as the baseline for developing a Monte-Carlo model. The other significant assumptions used in the Monte Carlo Simulation as of March 31, 2021 were as follows:

As of March 31, 2021

Contingent Value Rights

Credit risk assumption

9.6%

Time steps per year

30.00

Number of iterations

10,000

 

Note 6 –10. Commitments and Contingencies

 

Commitments and contingencies are described below and summarized by the following as of DecemberMarch 31, 2017:2021:

 

     Remaining                
  Total  2018  2019  2020  2021  2022  Thereafter 
Prescription Database $1,071,000  $498,000  $573,000  $-  $-  $-  $- 
Natesto  15,000,000   -   -   2,500,000   5,000,000   -   7,500,000 
Office Lease  318,000   72,000   111,000   108,000   27,000   -   - 
  $16,389,000  $570,000  $684,000  $2,608,000  $5,027,000  $-  $7,500,000 
  

Total

  

2021

  

2022

  

2023

  

2024

  

2025

  

Thereafter

 

Prescription database

 $1,145,000  $412,000  $733,000  $  $  $  $ 

Pediatric portfolio fixed payments and product minimums

  15,000,000   825,000   3,300,000   3,300,000   3,300,000   3,300,000   975,000 

Inventory purchase commitment

  1,472,000   736,000   736,000             

CVR liability

  12,000,000      2,000,000   5,000,000   5,000,000       

Product contingent liability

  2,500,000                  2,500,000 

Product milestone payments

  3,000,000      3,000,000             
                             
Total $35,117,000  $1,973,000  $9,769,000  $8,300,000  $8,300,000  $3,300,000  $3,475,000 

 

Prescription Database

 

In May 2016, Aytuthe Company entered into an agreement with a vendor that will provide Aytuit with prescription database information. AytuThe Company agreed to pay approximately $1.9$1.6 million over three years for access to the database of prescriptions written for Natesto. In January 2020, the Company amended the agreement and agreed to pay additional $0.6 million to add access to the database of prescriptions written for the Pediatric Portfolio. The payments have been broken down into quarterly payments.

 

NatestoPediatric Portfolio Fixed Payments and Product Milestone

 

In April 2016,The Company assumed two fixed, periodic payment obligations to an investor (the “Fixed Obligation”). Beginning November 1, 2019 through January 2021, the Company will pay monthly payments of $86,840, with a balloon payment of $15.0 million that was to be due in January 2021. A second fixed obligation requires the Company pay a minimum of $100,000 monthly through February 2026, except for $210,767 paid in January 2020. 

On May 29, 2020, the Company entered into an agreement with Acerus, whereby AytuEarly Payment Agreement and Escrow Instruction (the “Early Payment Agreement”) pursuant to which the Company agreed to pay $8.0$15.0 million forto the investor in early satisfaction of the Balloon Payment Obligation. The parties to the Early Payment Agreement acknowledged and agreed that the remaining fixed payments other than the Balloon Payment Obligation remain due and payable pursuant to the terms of the Agreement, and that nothing in the Early Payment Agreement alters, amends, or waives any provisions or obligations in the Waiver or the Investor agreement other than as expressly set forth therein.

In addition, the Company acquired a Supply and Distribution Agreement with Tris Pharma, Inc. ("TRIS"), (the “Karbinal Agreement”), under which the Company is granted the exclusive U.S. rightsright to Natesto (see Note 1).distribute and sell the product in the United States. The firstinitial term of the Karbinal Agreement was 20 years. The Company will pay TRIS a royalty equal to 23.5% of net sales. A third party agreed to offset the 23.5% royalty payable by 8.5%, for a net royalty equal to 15%, in fiscal year 2018 and 2019 for net sales of Karbinal.

The Karbinal Agreement make-whole payment totaling $2.0is capped at $2.1 million was paid in April 2016, the second installment payment was paid in October 2016.each year. The final payment totaling $4.0 million was paid in January 2017. Additionally, AytuKarbinal Agreement also contains minimum unit sales commitments, which is based on a commercial year that spans from August 1 through July 31, of 70,000 units annually through 2025. The Company is required to pay TRIS a royalty make milestone payments to Acerus. The first milestonewhole payment of $2.5$30 for each unit under the 70,000-unit annual minimum sales commitment through 2025. The annual payment is due in August of each year. The Karbinal Agreement also has multiple commercial milestone obligations that aggregate up to $3.0 million must be paid even ifbased on cumulative net sales, the milestonefirst of which is not reached. Astriggered at $40.0 million of the date of this report, Aytu anticipates making the second milestone payment of $5.0 million, along with the third milestone payment of $7.5 million upon reaching the milestones. net revenues.

 

Office LeaseInventory Purchase Commitment

On May 1, 2020, the Company's Innovus subsidiary entered into a Settlement Agreement and Release (the “Settlement Agreement”) with Hikma Pharmaceuticals USA, Inc. (“Hikma”). Pursuant to the settlement agreement, Innovus has agreed to purchase and Hikma has agreed to manufacture a minimum amount of the Company's branded fluticasone propionate nasal spray USP, 50 mcg per spray (FlutiCare®), under Hikma’s FDA approved ANDA No. 207957 in the U.S. The commitment requires Innovus to purchase three batches of product through fiscal year 2022 each of which amount to $1.0 million.

CVR Liability

On February 14, 2020, the Company closed on the Merger with Innovus Pharmaceuticals after approval by the stockholders of both companies on February 13, 2020. Upon closing the Merger, a subsidiary of the Company merged with and into Innovus and entered into a Contingent Value Rights Agreement (the “CVR Agreement”). Each CVR entitles its holder to receive its pro rata share, payable in cash or stock, at the option of Aytu, of certain payment amounts if the targets are met. If any of the payment amounts is earned, they are to be paid by the end of the first quarter of the calendar year following the year in which they are earned. Multiple revenue milestones can be earned in one year.

On March 31, 2020, the Company paid the CVR holders approximately 120,000 shares of the Company’s common stock to satisfy the $2.0 million obligation as a result of Innovus achieving the $24.0 million revenue milestone for calendar year ended December 31, 2019. As a result of this, the Company recognized a gain of approximately $0.3 million during the fiscal year ended June 30, 2020. On March 20, 2021, the Company paid the CVR holders approximately 103,000 shares of the Company’s common stock to satisfy one of two $1.0 million 2020 milestones, which relates to the Innovus achievement of $30.0 million in revenues during the 2020 calendar year. As a result of this, the Company recognized a gain of approximately $0.4 million during the three months ended March 31, 2021.The $1.0 million 2020 milestone for achieving profitability was not met.

Product Contingent Liability

 

In JuneFebruary 2015, Aytu entered into a 37-month operating lease for office space in Raleigh, North Carolina. This lease has initial base rent of $3,000 a month,Innovus acquired Novalere, which included the rights associated with total base rent over the termdistributing FlutiCare. As part of the leasemerger, Innovus is obligated to make five additional payments of $0.5 million each when certain levels of FlutiCare sales are achieved. The discounted value as of March 31, 2021, is approximately $112,000. In September 2015, the Company entered into a 37-month operating lease in Englewood, Colorado. This lease has an initial base rent of $9,000 a month with a total base rent over the term of the lease of approximately $318,000. In October 2017, the Company signed an amendment to the 37-month operating lease in Englewood, Colorado. The amendment extended the lease for an additional 24 months beginning October 1, 2018. The base rent will remain at $9,000 a month. The Company recognizes rent expense on a straight-line basis over the term of each lease. Differences between the straight-line net expenses on rent payments are classified as liabilities between current deferred rent and long-term deferred rent. Rent expense for the respective periods was as follows:

  Three Months Ended
December 31,
  Six Months Ended
December 31,
 
  2017  2016  2017  2016 
                 
Rent expense $35,000  $35,000  $70,000  $70,000 

Note 7 – Common Stock$0.2 million.

 

Capital Stock / Restricted StockProduct Milestone Payments

 

At December 31, 2017 and June 30, 2017,In connection with the Company’s intangible assets, Aytu had 4,894,638 and 824,831 common shares outstanding, respectively, and 1,900 and 0 preferred shares outstanding, respectively. has certain milestone payments, totaling $3.0 million, payable at a future date, which are not directly tied to future sales, but are payable upon other events certain to happen. These obligations are included in the valuation of the Company’s contingent consideration (see Note 9).

11. Capital Structure

The Company has 100.0200 million shares of common stock authorized with a par value of $0.0001 per share and 50.050 million shares of preferred stock authorized with a par value of $0.0001 per share, of which 10,000 were designated Series A Convertible Preferred Stock. share. On March 31, 2021 and June 30, 2020, Aytu had 23,457,887 and 12,583,736 common shares outstanding, respectively, and zero preferred shares outstanding, respectively.

Included in the common stock outstanding are 735,000274,635 shares of restricted stock issued to executives, directors, employees, and consultants.

 

On August 11, 2017, we entered into a Securities Purchase Agreement with various investors pursuant toIn June 2020, the Company initiated an at-the-market offering program ("ATM"), which we agreedallows the Company to sell Class A and Class B equity units forissue shares of the Company's common stock from time-to-time. The company has issued 430,230 shares of common stock, with total gross proceeds of $6.8 million before deducting underwriting discounts, commissions and other offering expenses payable by the Company of $0.2 million through June 30, 2020. The Company did not issue any shares of common stock under the ATM during the three months ended March 31, 2021, and has issued 352,912 shares of common stock under the ATM, with total gross proceeds of approximately $11.8$3.6 million before deducting underwriting discounts, commissions, and other offering expenses payable by the Company of $1.6 million during the nine months ended March 31, 2021. Since initiated in June 2020 through March 31, 2021, the total number of shares of common stock issued under the ATM was 783,142, with total gross proceeds of $10.4 million before deducting underwriting discounts, commissions and other offering expenses payable by the Company of $1.8 million.  Class A units consist of one (1) share

The Company entered into three separate registered direct stock offerings on March 10, 2020, March 12, 2020 and March 19, 2020 (the “March Offerings”) in which the Company issued a combination of common stock and a warrantwarrants. In July 2020, the Company paid $1.5 million issuance cost in cash related to purchase onethe March Offerings and one-half (1.5) shares of common stock and were sold at a negotiated price of $3.00 per unit. Class B units consist of one (1) share of our newly created Series A Convertible Preferred Stock (the “Series A Preferred Stock”) andissued 92,302 warrants to purchase one and one-half (1.5)92,302 shares of the Company's common stock with a weighted-average exercise price of $15.99 to an investment bank conjunction with the March 2020 offerings. The warrants have a term of one year from the issuance date. These warrants had at issuance a fair value of approximately $356,000 and were valued using a Black-Scholes model.

On December 10, 2020, the Company entered into an exchange agreement to exchange the $0.8 million of debt outstanding for each share130,081 shares of the Company's common stock (see Note 15).

On December 10, 2020, the Company entered into whichan underwriting agreement with H.C. Wainwright & Co., LLC (“Wainwright”) (as amended and restated, the Series A Preferred Stock is convertible and were sold at a negotiated price“Underwriting Agreement”). Pursuant to the Underwriting Agreement, the Company agreed to sell, in an upsized firm commitment offering, 4,166,667 shares (the “Shares”) of $1,000.00 per unit to those purchasers who, together with their affiliates and certain related parties, would beneficially own more than 9.99% of our outstandingthe Company’s common stock, following$0.0001 par value per share (the “Common Stock”), to Wainwright at an offering price to the offering. These Series A Preferredpublic of $6.00 per share, less underwriting discounts and commissions. In addition, pursuant to the Underwriting Agreement, the Company granted Wainwright a 30-day option to purchase up to an additional 625,000 shares of Common Stock at the same offering price to the public, less underwriting discounts and commissions. Wainwright exercised their over-allotment option in full, purchasing total common stock converts into common shares at $3.00 per common share, which when fully exercised will increase the common shares outstanding by 750,000of 4,791,667 shares. The offering was completed on August 15, 2017.

13

Company raised gross proceeds of $28.8 million through this offering. Offering costs totaled $2.6 million resulting in net cash proceeds of $26.2 million. In connection with the offering, wethe Company issued an aggregate of 3,196,665 shares of our common stock, 2,250 shares of Series A Preferred Stock and311,458 underwriter warrants to purchase up to an aggregate of 6,314,671311,458 shares of our common stock, which included 394,669stock. The exercise price per share of the underwriter warrants issuedis $7.50 (equal to 125% of the underwriters as compensationpublic offering price per share for the transaction.

We incurred certain expenses related to this transaction to attorneys and underwriters inclusive of a 9% cash fee and warrants to purchase 10% of the aggregate number of shares issued in the transaction.

In connection with the closing of the financing, we terminated the Purchase Agreement, dated as of July 27, 2016, by and between us and Lincoln Park Capital Fund, LLC. The termination was effective on August 16, 2017.

In September 2017, Aytu issued 200,000 shares of restricted stock to employees pursuant to the Aytu BioScience 2015 Stock Option and Incentive Plan, which vest in September 2027. In November 2017, 3,000 of these restricted shares were cancelled. Also in November 2017, Aytu issued 495,000 shares of restricted stock to executives, directors and consultants pursuant to the Aytu BioScience 2015 Stock Option and Incentive Plan, which vest in November 2027. The fair value of the 695,000 shares of restricted stock was $1.4 million on the grant dates. The expense associated with the restricted shares granted will be recognized using the straight-line method over the 10-year vesting period. The unrecognized expense related to these shares was $1,372,000 as of December 31, 2017. For the six months ended December 31, 2017, the compensation expense related to both grants was $26,000.

Aytu previously issued 43,000 shares of restricted stock outside the Aytu BioScience 2015 Stock Option and Inventive Plan, which vest in July 2026. The unrecognized expense related to these shares was $1,912,000 as of December 31, 2017 and will be recognized over the 10-year vesting period. During the six months ended December 31, 2017, the expense related to these awards was $78,000. During the quarter ended December 31, 2017, we modified 8,250 shares of restricted stock for accelerated vesting and recognized a reduction in aggregate stock compensation expense of $36,000.

In September 2017, Aytu issued 3,018 shares of common stock sold in connectionthe offering) and the underwriter warrants have a term of five years from the date of effectiveness of the offering. The underwriter warrants are exercisable immediately. These warrants have fair value of approximately $1.3 million and are classified with the Nuelle earn-outstockholders' equity.

On March 19, 2021, upon closing of the Neos Merger, the Company issued 5,447,000 shares of its common stock to acquire all the outstanding shares of common stock of Neos. In addition, pursuant to the agreement in the Neos Merger, the Company issued 24,804 shares of common stock to settle the accelerated restricted stock units of former Neos directors and officers (see Note 1)2). In October 2017, we made a $238,000 prepayment in Aytu

On March 20, 2021, the Company paid the CVR holders approximately 103,000 shares of the Company’s common stock towardto satisfy one of two $1.0 million 2020 milestones, which relates to the revenue earn-out payment for fiscal 2018.Innovus achievement of $30.0 million in revenues during the 2020 calendar year.

 

In October 2017, investors holding Aytu Series A Preferred shares exercised their right to convert 350 Aytu Series A Preferred shares into 116,666 shares of Aytu common stock.

Note 8 –12. Equity InstrumentsIncentive Plan

 

OptionsAytu 2015 Plan

 

On June 1, 2015, Aytu’sthe Company’s stockholders approved the Aytu BioScienceBioPharma 2015 Stock Option and Incentive Plan (the “2015“Aytu 2015 Plan”), which, as amended in July 2017, provides for the award of stock options, stock appreciation rights, restricted stock and other equity awards for up to an aggregate of 3.0 million shares of common stock. The shares of common stock underlying any awards that are forfeited, canceled, reacquired by Aytu prior to vesting, satisfied without any issuance of stock, expire or are otherwise terminated (other than by exercise) under the 2015 Plan will be added back to the shares of common stock available for issuance under the Aytu 2015 Plan. On February 13, 2020, the Company’s stockholders approved an increase to 5.0 million total shares of common stock in the Aytu 2015 Plan. As of DecemberMarch 31, 2017, we have 2,271,2052021, the Company had 4,603,990 shares that are available for grant under the Aytu 2015 Plan.

Neos 2015 Plan

 

Pursuant to the Neos Merger, the Company assumed 69,721 stock options and 35,728 restricted stock units (RSUs) previously granted under Neos plan. Accordingly, on April 19, 2021, the Company registered 105,449 shares of its common stock under the Neos Therapeutics, Inc. 2015 Stock Options and Incentive Plan 3.0 million shares(the "Neos 2015 Plan") with the SEC. The terms and conditions of the Company’s common stock,assumed equity securities will stay the same as they were under the previous Neos plan. The Company allocated costs of the replacement awards attributable to pre- and post-combination service periods. The pre-combination service costs were included in the considerations transferred. The remaining costs attributable to the post-combination service period are reservedbeing recognized as stock-based compensation expense over the remaining terms of the replacement awards. As of March 31, 2021, the Company had no shares that are available for issuance. grant under the Neos 2015 Plan.

Stock Options

Employee Stock Options:

The fair value of the options granted has beenis calculated using the Black-Scholes option pricing model. In order to calculate the fair value of the options, certain assumptions are made regarding components of the model, including the estimated fair value of the underlying common stock, the risk-free interest rate, volatility, expected dividend yield and the expected option life. Changes to the assumptions could cause significant adjustments to valuation. Aytu estimates the expected term of granted options based on the average of the vesting term and the contractual term of the options. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of the grant for treasury securities of similar maturity. The assumptions used to estimate the fair value of the options granted under the Neos 2015 Plan were as follows:

 

 14

As of March 31, 2021

Expected volatility

100.0%

Expected term (years)

4.00

Risk-free interest rate

0.73%

Dividend yield

 − 

 

Stock option activity is as follows:

 

  Number of Options  Weighted Average Exercise Price  Weighted Average Remaining Contractual Life in Years 
Outstanding June 30, 2017  38,263  $16.31   8.40 
Granted  -  $-     
Exercised  -  $-     
Forfeited/Cancelled  (1,468) $16.40     
Outstanding December 31, 2017  36,795  $16.30   7.58 
Exercisable at December 31, 2017  27,031  $16.27   7.33 
  

Number of Options

  

Weighted Average Exercise Price

  

Weighted Average Remaining Contractual Life in Years

  

Aggregate Intrinsic Value

 
Outstanding June 30, 2020  76,614  $19.39   9.67  $ − 

Granted

  69,721            

Forfeited/Cancelled

  (7,553)           

Expired

  (2,528)           

Outstanding at March 31, 2021

  136,254  $13.14   6.12  $ 

Exercisable at March 31, 2021

  20,569  $87.86   8.56  $ − 

As of March 31, 2021, there was $0.5 million unrecognized option-based compensation expense related to non-vested stock options. The Company expects to recognize this expense over a weighted-average period of 3.3 years.

Restricted Stock

Restricted stock activity is as follows:

  

Number of Shares

  Weighted Average Grant Date Fair Value  

Weighted Average Remaining Contractual Life in Years

 

Unvested at June 30, 2020

  418,454  $14.69   6.4 

Vested

  (143,977)        

Unvested at March 31, 2021

  274,477  $16.27   6.2 

Under the Aytu 2015 Plan, there was $4.0 million of total unrecognized stock-based compensation expense related to the non-vested restricted stock as of March 31, 2021. The Company expects to recognize this expense over a weighted-average period of 6.2 years. The Company previously issued 158 shares of restricted stock outside the Aytu 2015 Plan, which vest in July 2026. The unrecognized expense related to these shares was $1.1 million as of March 31, 2021 and is expected to be recognized over the weighted average period of 5.3 years.

Restricted Stock Unit

On March 31, 2021, the Company granted 55,000 restricted stock units ("RSUs") to a member of its management. One-third of the RSUs that vest on April 1, 2022, and 1/12 vest on the first day of each quarter thereafter such that all the RSUs will be fully-vested on the third anniversary of the grant. The grant date fair value of $7.60 per share.

Restricted stock unit activity is as follows:

  

Number of Shares

  

Weighted Average Grant Date Fair Value

  

Weighted Average Remaining Contractual Life in Years

 

Unvested at June 30, 2020

            

Granted

  90,728  $8.35   2.21 
Vested  (2,822)        
Forfeited  (544)        

Unvested at March 31, 2021

  87,362  $8.31   2.26 

Under the Neos 2015 Plan, there was $0.6 million of total unrecognized stock-based compensation expense related to the non-vested restricted stock units as of March 31, 2021. The Company expects to recognize this expense over a weighted-average period of 2.2 years.

 

Stock-based compensation expense related to the fair value of stock options and restricted stock was included in the statements of operations as selling, general and administrative expenses as set forth in the table below. Aytu determined the fair value of stock compensation as of the date of grant using the Black-Scholes option pricing model and expenses the fair value ratably over the vesting period. The following table summarizes stock-based compensation expense for the stock option and restricted stock issuances for the three and six months ended December 31, 2017 and 2016:below:

 

  Three Months Ended
December 31,
  Six Months Ended
December 31,
 
Selling, general and administrative: 2017  2016  2017  2016 
             
Stock options $81,000  $381,000  $276,000  $1,425,000 
                 
Restricted Stock  32,000   82,000   104,000   157,000 
Total share-based compensation expense $113,000  $463,000  $380,000  $1,582,000 
  

Three Months Ended March 31,

  

Nine Months Ended March 31,

 
  2021  2020  2021  2020 

Cost of sales

 $9,000  $  $9,000  $ 
Research and development  3,000      3,000    

Sales, general and administrative

  1,514,000   264,000   2,473,000   591,000 

Total stock-based compensation expense

 $1,526,000  $264,000  $2,485,000  $591,000 

 

As of DecemberMarch 31, 2017, there was $390,0002021, the Company recorded a liability of total unrecognized$0.1 million in accrued expense for the share-based payment to certain departing officers. 

The stock-based compensation expense relatedincluded in the table above is attributable to non-vested stock options.options and restricted stock of $0.1 million and $1.3 million, respectively, for the three months ended March 31, 2021 and $0.3 million and $2.1 million, respectively, for the nine months ended March 31, 2021. The Company expectsstock-based compensation expense included in the table above is attributable to recognize this expense over a weighted-average periodstock options and restricted stock of 1.37 years.$7,000 and $0.3 million, respectively, for the three months ended March 31, 2020 and $14,000 and $0.6 million, respectively, for the nine months ended March 31, 2020.

13. Warrants

 

WarrantsIn July 2020, the Company issued 92,302 shares of warrants with a weighted average exercise price of $15.99 in connection with the March Offerings. The warrants have a term of one year from the issuance date. These warrants have a fair value of $356,000 and are classified within stockholders' equity.

On December 15, 2020, the Company issued 311,458 shares of warrants with an exercise price of $7.50 in connection with the December 15, 2020 offering. These warrants have a fair value of approximately $1.3 million and are classified within stockholders' equity.

 

A summary of allequity-based warrants is as follows:

 

  Number of Warrants  Weighted Average Exercise Price  Weighted Average Remaining Contractual Life in Years 
Outstanding June 30, 2017  286,049  $50.29   4.23 
             
Warrants issued in connection with the August 2017 private offering  5,920,002  $3.60     
Warrants issued to underwriters in connection with the August 2017 private offering  394,669  $3.60     
Outstanding December 31, 2017  6,600,720  $5.62   4.61 
  

Number of Warrants

  

Weighted Average Exercise Price

  

Weighted Average Remaining Contractual Life in Years

 

Outstanding June 30, 2020

  2,288,528  $30.26   2.00 

Warrants issued

  403,760         

Warrants expired

  (1,434,763)        

Outstanding March 31, 2021

  1,257,525  $41.42   3.05 

14. Net Loss per Common Share

Basic income (loss) per common share is calculated by dividing the net income (loss) available to the common shareholders by the weighted average number of common shares outstanding during that period. Diluted net loss per share reflects the potential of securities that could share in the net loss of the Company. For each three-month period presented, the basic and diluted loss per share were the same for 2020 and 2019, as they were not included in the calculation of the diluted net loss per share because they would have been anti-dilutive.

The following table sets-forth securities that could be potentially dilutive, but as of March 31, 2021 and 2020 are anti-dilutive, and therefore excluded from the calculation of diluted earnings per share.

   

As of March 31,

 
   

2021

  

2020

 

Warrants to purchase common stock - liability classified

  24,105   24,105 

Warrant to purchase common stock - equity classified

(Note 13)

  1,257,525   3,098,604 

Employee stock options

(Note 12)

  136,254   33,844 

Employee unvested restricted stock

(Note 12)

  274,635   334,423 
Employee unvested restricted stock units(Note 12)  87,362    

Convertible preferred stock

(Note 11)

     980,584 
Total  1,779,881   4,471,560 

15. Debt

The Aytu BioPharma Note. On February 27, 2020, the Company issued a $0.8 million promissory note (the “Note”) and received consideration of approximately $0.6 million. The Note had an eight-month term with principal and interest payable on November 1, 2020, and the recognition of approximately $0.2 million of debt discount related to the issuance of promissory notes. The discount was amortized over the life of the promissory notes through the fourth quarter of calendar 2020. During the three and nine-months ended months ended March 31, 2021 and 2020 the Company recorded approximately $15,000 and $70,000, respectively, of related amortization. On December 10, 2020, the Company agreed to exchange the Note for 130,081 shares of the Company's common stock in lieu of $0.8 million in cash that would otherwise have been due to satisfy this obligation on March 31, 2021. As a result of this exchange, the Company recognized a non-cash loss of approximately $0.3 million during the nine months ended March 31, 2021.

The Innovus Notes. On January 9, 2020, prior to the completion of the merger, Innovus Pharmaceuticals, Inc., entered into a note agreement upon which it received gross proceeds of $0.4 million with a principal amount of $0.5 million. The note requires twelve equal monthly payments of approximately $45,000. As of March 31, 2021, the balance of the note has been paid.

The Neos Revolving Loans. On October 2, 2019, Neos entered into a senior secured credit agreement with Encina Business Credit, LLC (“Encina”) as agent for the lenders (the “Loan Agreement”). Under the Loan Agreement, Encina will extend up to $25.0 million in secured revolving loans to Neos (the “Revolving Loans”), of which up to $2.5 million may be available for short-term swingline loans, against 85% of eligible accounts receivable. The Revolving Loans bear variable interest through maturity at the one-month London Interbank Offered Rate (“LIBOR”), plus an applicable margin of 4.50%. In addition, Neos is required to pay an unused line fee of 0.50% of the average unused portion of the maximum revolving facility amount during the immediately preceding month. Interest is payable monthly in arrears, upon a prepayment of a loan and on the maturity date. The maturity date under the Loan Agreement is May 11, 2022.

In the event that, for any reason, all or any portion of the lender's commitment to make revolving loans is terminated prior to the scheduled maturity date, in addition to the payment of the principal amount and all unpaid accrued interest and other amounts due thereon, Neos is required to pay to the lender a prepayment fee equal to (i) 1.0% of the revolving loan commitment if such event occurs on or before October 2, 2021, and (ii) 0.5% of the revolving loan commitment if such event occurs after October 2, 2021 but before May 11, 2022. Neos may permanently terminate the revolving loan facility by prepaying all outstanding principal amounts and all unpaid accrued interest and other amounts due thereon, subject to at least five business days prior notice to the lender and the payment of a prepayment fee as described above.

The Agreement contains customary affirmative covenants, negative covenants and events of default, as defined in the Loan Agreement, including covenants and restrictions that, among other things, require Neos to satisfy certain capital expenditure and other financial covenants, and restrict Neos’ ability to incur liens, incur additional indebtedness, engage in mergers and acquisitions or make asset sales without the prior written consent of the Lenders. A failure to comply with these covenants could permit the Lenders to declare Neos’ obligations under the Loan Agreement, together with accrued interest and fees, to be immediately due and payable, plus any applicable additional amounts relating to a prepayment or termination, as described above. Neos evaluated to determine if the embedded components in the agreement qualified as derivatives requiring separate recognition.  

 

In connection with our August 2017 private offering, we issued warrantsthe closing of the Neos Merger, Neos and Encina entered into a Consent, Waiver and First Amendment to purchase an aggregatethe Loan Agreement, dated as of 6,314,671March 19, 2021 (the “Encina Consent, Waiver and Amendment”). Pursuant to the Consent, Waiver and First Amendment, Encina (i) irrevocably waives the right to impose the default rate of interest solely to the extent resulting from the inclusion of a "going concern" qualification in the audited financial statements of Neos on a consolidated basis for the fiscal year ending December 31, 2020 (the “Specified Default), (ii) the right to impose the Default Rate of interest under Section 3.1 of the Loan Agreement, or to collect interest accruing at such Default Rate that Lenders had a lawful right to collect or apply with respect to any such Specified Default, and (iii) makes certain other modifications to the Encina Loan Agreement to reflect the consummation of the Neos Merger and the status of Neos as a wholly-owned subsidiary of Aytu, in each case subject to the terms and conditions of the Encina Consent, Waiver and Amendment. 

Total interest expense was $28,000 for the period beginning March 20, 2021 and ended March 31, 2021. As of March 31, 2021, $4.7 million borrowing was outstanding under the Revolving Loan and Neos was in compliance with the covenants under the Loan Agreement as amended.

The Neos Senior Secured Credit Facility. On May 11, 2016, Neos entered into a $60.0 million senior secured credit facility (the “Facility”) with Deerfield Private Design Fund III, L.P. (66 2/3% of Facility) and Deerfield Partners, L.P. (33 1/3% of Facility) (collectively, “Deerfield”). As of March 19, 2021, remaining principal on the Facility was $15.6 million, with $0.6 million due on April 11, 2021 and with a final payment of principal, interest and all other obligations under the Facility due May 11, 2022. Interest is due quarterly beginning in June 2021, at a rate of 12.95% per year. Borrowings under the Facility are collateralized by substantially all of Neos’ assets, except assets under finance lease. The terms of the Facility require Neos to maintain cash on deposit of not less than $5.0 million.

Long-term debt consists of the following;

  

March 31,2021

 

Senior secured credit facility, due on May 11, 2022

 $15,625,000 

Exit fee

  1,000,000 

Unamortized premium

  724,000 

Financing leases, maturing through May 2024

  307,000 

Total debt

  17,656,000 

Less: current portion

  (725,000)

Long-term debt

 $16,931,000 

In connection with the Neos Merger, Neos and Deerfield entered into a Consent, Waiver and Sixth Amendment to the Facility, dated as of March 19, 2021 (the “Deerfield Consent, Waiver and Amendment”). Pursuant to the Consent, Waiver and Sixth Amendment, Deerfield (i) consented to certain amendments to the Encina loan documents, (ii) irrevocably waive the Going Concern Conditions as described in the Deerfield Consent, Waiver and Amendment and their right to impose the default rate of interest as provided for in the Facility as of May 11, 2016, or to collect interest accruing at such default rate of interest, that the Lenders had a lawful right to collect or apply with respect to any such Event of Default for failure to satisfy such Going Concern Condition, (iii) subject the Company and its subsidiaries to certain restrictive covenants including limitations on the incurrence of debt, granting of liens and transfers of assets of the Company and its subsidiaries and (iv) makes certain other modifications to the Facility to reflect the consummation of the Neos Merger and the status of Neos as a wholly-owned subsidiary of the Company. Such modifications also include the prepayment of $15.0 million by the Company of the principal of the loan that was otherwise due on May 11, 2021 plus any accrued interest thereon through March 19, 2021, plus a make-whole payment equal to the interest that would otherwise have been due on that $15.0 million for the period beginning March 19, 2021 through May 11, 2021. The Sixth Amendment also eliminated the right of Deerfield to convert outstanding amounts of the loans into conversion shares and the right of Neos to make payments to Deerfield in the form of shares of common stock at an exercise pricestock. The Company is a guarantor under the Facility.

Pursuant to the terms of $3.60the Facility, as amended, the $15.0 million principal prepayment was paid in cash on March 19, 2021, and a termthe carrying amount of five years to investors and underwriters. These warrants arethe remaining outstanding debt was $16.6 million. As the Neos Merger was accounted for using derivative liability treatment (see Note 5).

All warrants issued in fiscal 2018 were valued using the lattice option pricing model. In order to calculateas a business combination under Topic 805, Neos evaluated and determined that the fair value of the warrants, certain assumptions were made, includingremaining outstanding debt was $17.4 million as of March 20, 2021. Accordingly, Neos recorded a premium of $0.8 million, which is the selling price ordifference between carrying amount and the fair market value of the underlying common stock, risk-freedebt and is being amortized into interest rate, volatility, expected dividend yield, and contractual life. Changes toexpense using the assumptions could cause significant adjustments to valuation. Theeffective interest method over the remaining term of the debt. As of March 31, 2021, the Company estimated a volatility factor utilizing a weighted average of comparable published betas of peer companies. The risk-freewas in compliance with the covenants under the Facility as amended. Total interest rate is basedexpense on the U.S. Treasury yield in effect atFacility, net of premium amortization, was $46,000 for the time of the grant for treasury securities of similar maturity.period beginning March 20, 2021 and ended March 31, 2021.

 

Significant assumptions in valuing the warrants issued during the December 31, 2017 quarterFuture principal payments of long-term debt, including financing leases, are included in Note 5.as follows:

 

15
  

March 31,2021

 

2021

 $650,000 

2022

  16,102,000 

2023

  96,000 

2024

  84,000 

Future principal payments

  16,932,000 

Add unamortized premium

  724,000 

Less current portion

  (725,000)

Long-term debt

 $16,931,000 

 

Note 9 – Related Party Transactions

Executive Stock Purchases16. Segment reporting

 

Two Aytu executive officers, Joshua DisbrowThe Company’s chief operating decision maker (the “CODM”), who is the Company’s Chief Executive Officer, allocates resources and Jarrett Disbrow, participated inassesses performance based on financial information of the August 2017 offering. Each officer purchased 83,333 units.Company. The CODM reviews financial information presented for each reportable segment for purposes of making operating decisions and assessing financial performance.

 

Services Agreement

In July 2015, Aytu entered into an agreement with Ampio, whereby Aytu agreed to pay Ampio a set amount per month for shared overhead, which included costs related to a shared corporate staff and other miscellaneous overhead expenses. This agreement as amended in November 2015, April 2016, July 2016, January 2017 required a monthly payment of $12,000. This agreement was terminated in June 2017.

Sponsored Research Agreement

In June 2013, Luoxis entered into a sponsored research agreement with TRLLC, an entity controlled by Ampio’s director and Chief Scientific Officer, Dr. Bar-Or. The agreement was amended in January 2015 and provided for Luoxis (now Aytu) to pay $6,000 per month to TRLLC in consideration for services related to research and development of the Oxidation Reduction Potential platform. In March 2014, Luoxis also agreed to pay a sum of $615,000 which was being amortized over the contractual term of 60.5 months and was divided between current and long-term on the balance sheet; as of September 2014, this amount had been paid in full. This agreement was terminated in March 2017.

Note 10 – Segment Information

AytuCompany manages our Company and aggregates ourits operational and financial information in accordance with two reportable segments: Aytu BioPharma and Aytu Women’sConsumer Health. The Aytu BioPharma segment consists of our core male urologythe Company’s prescription products. The Aytu Women’sConsumer Health segment contains our women’s healththe Company’s consumer healthcare products. The inclusion of the prescription product due to the Neos Merger is preliminary and subject to further evaluation as the Company begins to integrate Neos into the Company's operations.

Select financial information for these segments is as follows:

 

  Three Months Ended
December 31
  Six Months Ended
December 31
 
  2017  2016  2017  2016 
Consolidated revenue:            
Aytu $985,000  $794,000  $1,957,000  $1,492,000 
Aytu Women's Health  66,000   -   171,000   - 
                 
Consolidated revenue $1,051,000  $794,000  $2,128,000  $1,492,000 
                 
Consolidated net loss:                
Aytu $(3,151,000) $(4,817,000) $(6,876,000) $(10,542,000)
Aytu Women's Health  (522,000)  -   (1,042,000)  - 
                 
Consolidated net loss $(3,673,000) $(4,817,000) $(7,918,000) $(10,542,000)
                 
Total consolidated assets:                
Aytu $15,842,000  $21,506,000  $15,842,000  $21,506,000 
Aytu Women's Health  3,016,000   -   3,016,000   - 
                 
Total consolidated assets $18,858,000  $21,506,000  $18,858,000  $21,506,000 
  

Three months Ended March 31,

  

Nine Months Ended March 31,

 
  

2021

  

2020

  

2021

  

2020

 

Consolidated revenue:

                

Aytu BioPharma

 $5,127,000  $4,703,000  $18,091,000  $9,318,000 

Aytu Consumer Health

  8,355,000   3,453,000   24,059,000   3,453,000 

Consolidated revenue

 $13,482,000  $8,156,000  $42,150,000  $12,771,000 
                 

Consolidated net loss:

                

Aytu BioPharma

 $(23,570,000) $(4,421,000) $(34,788,000) $(9,565,000)

Aytu Consumer Health

  (1,890,000)  (911,000)  (4,503,000)  (911,000)

Consolidated net loss

 $(25,460,000) $(5,332,000) $(39,291,000) $(10,476,000)

 

16
  

As of

  

As of

 
  

March 31,

  

June 30,

 
  

2021

  

2020

 

Total assets:

        

Aytu BioPharma

 $241,593,000  $126,267,000 

Aytu Consumer Health

  29,964,000   27,026,000 

Total assets

 $271,557,000  $153,293,000 

 

Note 11 – Going Concern17. License agreements

 

As reflectedIn October 2018, Neos entered into an Exclusive License Agreement (“NeuRx License”) with NeuRx Pharmaceuticals LLC (“NeuRx”), pursuant to which NeuRx granted Neos an exclusive, worldwide, royalty-bearing license to research, develop, manufacture, and commercialize certain pharmaceutical products containing NeuRx’s proprietary compound designated as NRX-101, referred to by Neos as NT0502. NT0502 is a new chemical entity that is being developed by Neos for the treatment of sialorrhea, which is excessive salivation or drooling. Under the NeuRx License, Neos made an upfront payment of $0.2 million to NeuRx upon the execution of the agreement. Neos made a payment of $0.2 million following receipt of notice of allowance of the first Licensed Patent by the United States Patent and Trademark Office (“USPTO”), as defined in the accompanying balance sheetNeuRx License. Such Licensed Patent subsequently was issued by the USPTO. In April 2020, Neos met the completion of the first Pilot PK Study milestone, as defined in the NeuRx License, triggering the cash payment of December 31,$0.3 million. Neos may in the future be required to make certain development and milestone payments and royalties based on annual net sales, as defined in the NeuRx License. Royalties are to be paid on a country-by-country and licensed product-by-licensed product basis, during the period of time beginning on the first commercial sale of such licensed product in such country and continuing until the later of: (i) the expiration of the last-to-expire valid claim in any licensed patent in such country that covers such licensed product in such country; and/or (ii) expiration of regulatory exclusivity of such licensed product in such country.

Under the Teva Licensing Agreement, Neos granted Teva a non-exclusive license to certain patents owned by Neos by which Teva has the right to manufacture and market its generic version of Cotempla XR-ODT under its ANDA beginning on July 1, 2026, or earlier under certain circumstances. The Teva Licensing Agreement has been submitted to the applicable governmental agencies.

Under the Actavis Licensing Agreement, Neos granted Actavis a non-exclusive license to certain patents owned by Neos by which Actavis has the right to manufacture and market its generic version of Adzenys XR-ODT under its ANDA beginning on September 1, 2025, or earlier under certain circumstances. The Actavis Licensing Agreement has been submitted to the applicable governmental agencies.

In July 2014, Neos entered into a Settlement Agreement and an associated License Agreement (the “2014 License Agreement”) with Shire LLC (“Shire”) for a non-exclusive license to certain patents for certain activities with respect to Neos’ New Drug Application (the “NDA”) No. 204326 for an extended-release orally disintegrating amphetamine polistirex tablet. In accordance with the terms of the 2014 License Agreement, following the receipt of the approval from the FDA for Adzenys XR-ODT, Neos paid a lump sum, non-refundable license fee of an amount less than $1.0 million in February 2016. Neos is paying a single digit royalty on net sales of Adzenys XR-ODT during the life of the patents.

In March 2017, Neos entered into a License Agreement (the “2017 License Agreement”) with Shire, pursuant to which Shire granted Neos a non-exclusive license to certain patents owned by Shire for certain activities with respect to Neos’ NDA No. 204325 for an extended-release amphetamine oral suspension. In accordance with the terms of the 2017 License Agreement, following the receipt of the approval from the FDA for Adzenys ER, Neos paid a lump sum, non-refundable license fee of an amount less than $1.0 million in October 2017. Neos is paying a single digit royalty on net sales of Adzenys ER during the life of the patents.

The royalties are recorded as cost of goods sold in the same period as the net sales upon which they are calculated.

Additionally, each of the 2014 and 2017 License Agreements contains a covenant from Shire not to file a patent infringement suit against Neos alleging that Adzenys XR-ODT or Adzenys ER, respectively, infringes the Shire patents.

18. Related party Transactions

Tris Pharma, Inc.

On November 2, 2018, the Company had approximately $4.0 million in cash including approximately $76,000 in restricted cash (that is expectedentered into a License, Development, Manufacturing and Supply Agreement (the “Tris License Agreement”). On November 1, 2019, the Company acquired the rights to be released in fiscal year 2018). In addition, for the quarter ended December 31, 2017, and for the most recent four quarters ended December 31, 2017, we used an average of $3.2 million of cash per quarter for operating activities. Looking forward, we expect cash used in operating activities to be in the range of historical usage rates, therefore, indicating substantial doubt about the Company’s ability to continueKarbinal as a going concern. We expect to requireresult of the acquisition of the Pediatric Portfolio from Cerecor, Inc. (See Notes 2 and 10). Mr. Ketan Mehta served as a cash infusion duringDirector on the fourth quarterBoard of fiscal year 2018 to sustain operations. 

With the expectation of continuing operating losses, the Company expects that its current cash resources will not be sufficient to sustain operations for a period greater than one year from the date of this report. The abilityDirectors of the Company and is also the Chief Executive Officer of Tris Pharma, Inc. ("TRIS"). The Company paid TRIS approximately $0.9 million and $0 million during the three months ended March 31, 2021 and 2020, respectively for a combination of royalty payments, inventory purchases and other payments as contractually required. The Company’s liabilities, including accrued royalties, contingent consideration and fixed payment obligations were $22.8 million and $25.0 million as of March 31, 2021 and 2020, respectively. In October 2020, the Company paid Tris approximately $1.6 million related to continue its operations is dependent on management's plans, which include continuing to buildKarbinal fixed payment obligation. On March 19, 2021, Mr. Ketan Mehta resigned as a Director on the historical growth trajectory of Natesto and accessing the capital markets through the sale of our securities. Based on our ability to raise capital in the past as well as our continued growth, the Company believes additional financing will be available and will continue to be available to support current level of operations for at least the next 12 months from the date of this report. There can be no assurance that such financing will be available or on terms which are favorable to the Company. While managementBoard of the Company, believes that it hasand TRIS will no longer be considered a plan to fund ongoing operations, there is no assurance that its plan will be successfully implemented or realized.related party in the future.

 

The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. These financial statements do not include any adjustments relating to the recovery of the recorded assets or the classification of the liabilities that might be necessary should the Company be unable to continue as a going concern.

Note 12 –19. Subsequent Events

 

On January 2, 2018, Aytu issued 75,000 restricted shares to one of its executive officersApril 12, 2021, the Company, Rumpus VEDS, LLC, Rumpus Therapeutics, LLC, Rumpus Vascular, LLC (together with Rumpus VEDS, LLC and Rumpus Therapeutics, LLC, the “Sellers”), Christopher Brooke and Nathaniel Massari entered into and closed on an asset purchase agreement (the “Purchase Agreement”), pursuant to his employment agreement.which the Company acquired certain rights and other assets, including key commercial licenses, relating to Enzastaurin and to Sellers’ business of developing pharmaceutical products from the Sellers for $1.5 million in cash and, upon the achievement of certain regulatory and commercial milestones, up to $67.5 million in earn-out payments (the “Earn-Out Payments”). The Earn-Out Payments are payable in cash or shares of common stock of the Company, generally at the Company’s option. The shares are subject to certain vesting conditions.  of common stock will be issued under the Company’s Acquisition Shelf on Form S-4 (SEC File No. 333-239011).

 

On May 17, 2021, Ms. Beth Hecht and Mr. Jerry McLaughlin, announced their resignation from the board of directors effective immediately.  Ms. Hecht and Mr. McLaughlin will not run for election as members of the Company’s board of directors at the next annual stockholder meeting of the Company, which is currently scheduled to take place on May 21, 2021 and the Company will disseminate additional proxy soliciting materials to its stockholders to announce this resignation.  

 

Item 2. Management’sManagements Discussion and Analysis of Financial Condition and Results of Operations.

 

This discussion should be read in conjunction with Aytu BioScience,BioPharma, Inc.’s Annual Report on Form 10-K for the year ended June 30, 2017,2020, filed on August 31, 2017.October 6, 2020. The following discussion and analysis containscontain forward-looking statements that involve risks and uncertainties. Actual results could differ materially from those projected in the forward-looking statements. For additional information regarding these risks and uncertainties, please see the risk factors included in Aytu’s Form 10-K filed with the Securities and Exchange Commission on August 31, 2017.October 6, 2020.

 

Overview/recent eventsOverview

 

We are a commercial-stage specialty life sciencepharmaceutical company concentratingfocused on commercializing novel therapeutics and consumer healthcare products. We currently operate our Aytu BioPharma business, consisting of our prescription pharmaceutical products (the “Rx Portfolio”), and our Aytu consumer healthcare products business (the “Consumer Health Portfolio”). Our Aytu BioPharma business is focused on commercializing prescription pharmaceutical products for the treatment of attention deficit hyperactivity disorder ("ADHD"), allergies, insomnia, and various pediatric conditions. Our Aytu Consumer Health business is focused on commercializing consumer healthcare products. We were incorporated as Rosewind Corporation on August 9, 2002 in the State of Colorado. We were re-incorporated in the state of Delaware on June 8, 2015.

The Rx Portfolio consists of (i) Adzenys XR-ODT (amphetamine) extended-release orally disintegrating tablets, Cotempla XR-ODT (methylphenidate) extended-release orally disintegrating tablets and Adzenys-ER (amphetamine) extended-release oral suspension for the treatment of attention deficit hyperactivity disorder (ii) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various formulations for infants and children with fluoride deficiency, (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions, (iv) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, (v) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup, and (vi) a generic Tussionex (hydrocodone and chlorpheniramine) (“generic Tussionex”), extended-release oral suspension for the treatment of cough and upper respiratory symptoms of a cold.

The Consumer Health Portfolio consists of over twenty consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health commercialized through direct-to-consumer marketing channels utilizing our proprietary Beyond Human marketing and sales platform and e-commerce platforms.

On March 31, 2021, we and Acerus Pharmaceuticals Corporation (“Acerus”) entered into a termination and transition agreement (the “Termination Agreement”) to terminate the License and Supply Agreement previously entered into on July 29, 2019. Pursuant to the Termination Agreement, we ceased all sales, marketing and promotions of Natesto, and Acerus agreed to pay us an aggregate amount of $7.5 million, payable in equal monthly installment payments for a period of 30 consecutive months. The original License and Supply Agreement was effective July 1, 2016 and was amended on July 29, 2019. Following the effectiveness of the original License and Supply Agreement, we built a 30-person sales force to relaunch Natesto following the termination of a license agreement between Acerus and Endo Pharmaceuticals that resulted in the rights to Natesto in North America reverting back to Acerus. 

On March 19, 2021, we acquired Neos Therapeutics, Inc. (“Neos”), a commercial-stage pharmaceutical company developing and commercializingmanufacturing central nervous system-focused products (the “Neos Merger”). Neos commercializes Adzenys XR-ODT, Cotempla XR-ODT and Adzenys-ER in the United States using Neos' internal commercial organization. These commercial products are extended-release (“XR”) medications in patient-friendly, orally disintegrating tablet (“ODT”) or oral suspension dosage forms that utilize our microparticle modified-release drug delivery technology platform. Neos received approval from the U.S. Food and Drug Administration (“FDA”) for these three products. In addition, Neos manufactures and sells generic Tussionex.

In April of 2020, we entered into a licensing agreement with Cedars-Sinai Medical Center to secure worldwide rights to various potential esophageal and nasopharyngeal uses of Healight, an initial focus on urological diseasesinvestigational medical device platform technology. Healight has demonstrated safety and conditions. We are currentlyefficacy in a proof-of-concept clinical study in SARS-CoV-2 patients, and we plan to advance this technology to further assess its safety and efficacy in additional randomized, controlled human studies, initially focused on addressing significant medical needs in the areas of hypogonadism, male infertility, urological cancers and female personal care.SARS-CoV-2 patients.

 

AsOur strategy is to continue building our portfolio of the daterevenue-generating products, leveraging our focused commercial team and expertise to build leading brands within large therapeutic markets.

Strategic Growth Initiatives

Pursuant to our strategy of this Report,identifying and acquiring complementary assets and companies, we have financed operationsexpect to substantially increase our revenue generating capacity and provide opportunities to reduce our combined operating losses through a combination of privateour recent acquisitions and public debtrevenue growth.

 Strategic Rx Acquisitions. On March 19, 2021, we closed on the merger with Neos after approval by the stockholders of Neos on March 18, 2021 and equity financings including net proceeds from the private placements of stock and convertible notes. Although it is difficult to predict our liquidity requirements, based upon our current operating plan, asapproval of the dateconsideration to be delivered by us in connection with the merger by the shareholders of this Report,Aytu, also on March 18, 2021. We expect the Neos Merger to accelerate our path to profitability, with estimated annualized cost synergies of up to approximately $15.0 million beginning FY 2022. Neos’ established, multi-brand ADHD portfolio will enhance our footprint in pediatrics and expand our presence in adjacent specialty care segments. We also have an opportunity to leverage and further enhance Neos RxConnect, a best-in-class patient support program, for our heritage product portfolio of best-in-class prescription therapeutics, and potentially, our consumer health products.

On November 1 2019, we believeacquired the Cerecor, Inc.'s ("Cerecor") portfolio of prescription pediatric therapeutics (the “Pediatric Portfolio”). At closing, the Pediatric Portfolio consisted of four pharmaceutical and other prescription products consisting of (i) Cefaclor for Oral Suspension, (ii) Karbinal ER, (iii) Poly- Vi-Flor, and (iv) Tri-Vi-Flor. Total consideration transferred consisted of $4.5 million cash and approximately 9.8 million shares of Series G Convertible Preferred Stock, plus the assumption of not more than $3.5 million of Medicaid rebates and products returns. In addition, we will have sufficient cash to meet our projected operating requirements intohired the fourth quartermajority of fiscal 2018, at which point we anticipate the need for additional capital. See “Liquidity and Capital Resources.”Cerecor’s commercial workforce.

 

We have recently begunassumed obligations due to an investor including fixed and variable payments. We assumed fixed monthly payments equal to $0.1 million from November 2019 through January 2021 plus $15.0 million due in January 2021. Monthly variable payments due to the same investor are equal to 15% of net revenue generated from a subset of the Product Portfolio, subject to an aggregate monthly minimum of $0.1 million, except for January 2020, when a one-time payment of $0.2 million was due and paid. The variable payment obligation continues until the earlier of: (i) aggregate variable payments of approximately $9.5 million have been made, or (ii) February 12, 2026. We subsequently paid down the $15.0 million balloon payment early in June 2020.

Further, certain of the products in the Pediatric Portfolio require royalty payments ranging from 15.0% to 38.0% of net revenue. One of the products in the Pediatric Portfolio requires us to generate material revenues fromminimum annual sales sufficient to represent annual royalties of approximately $2.1 million.

Consumer Health Acquisitions. On February 14, 2020, we closed on the commercializationmerger with Innovus Pharmaceuticals after approval by the stockholders of both companies on February 13, 2020. The acquisition of Innovus has enabled us to expand into the consumer healthcare market with Innovus’ over-the-counter medicines and other consumer health products. We expect Innovus to continue to develop additional consumer healthcare products and expand its product portfolio. This, we expect, will drive additional revenue for our consumer health subsidiary and contribute meaningfully to the company's overall revenue growth.

In the near-term, we expect to create value for shareholders by implementing a focused strategy of increasing sales of our products. We recognized approximately $1.1 millionprescription therapeutics while leveraging our commercial infrastructure. Further, we expect to increase sales of our consumer healthcare product portfolio. Further, we expect to expand both our Rx and $2.1 million in revenue from Natesto, ProstaScint, MiOXSYSconsumer health product portfolios through continuous business and Fiera sales during the threeproduct development. Additionally we recently acquired a late-stage asset for development of a rare connective tissue disorder. Finally, we expect to identify operational efficiencies and six months ended December 31, 2017. We have incurred accumulated net losses sinceremove redundancies identified through our inception,recent transactions and at December 31, 2017, we had an accumulated deficit of $77.0 million. Our net loss was $3.7 million and $7.9 million for the three and six months ended December 31, 2017 and we used $7.3 million of cash in operating activities during the six months ended December 31, 2017.implement expense reductions accordingly.

 

ACCOUNTING POLICIES

 

Significant Accounting Policies and Estimates

 

Our consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America.U.S. GAAP. The preparation of the consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities atas of the date of the consolidated financial statements, and the reported amounts of expenses during the reporting period. On an on-goingongoing basis, management evaluates its estimates and judgments, including those related to recoverability and useful lives of long-lived assets, stock compensation, valuation of derivative instruments, allowances, contingent consideration, contingent value rights ("CVR"), fixed payment arrangements and contingencies.going concern. Management bases its estimates and judgments on historical experience and on various other factors, including the ongoing COVID-19 pandemic, that are believedwe believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value 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 methods, estimates, and judgments used by us in applying these critical accounting policies have a significant impact on the results we report in our consolidated financial statements. Our significant accounting policies and estimates are included in our Annual Report on Form 10-K for the fiscal year ended June 30, 2017,2020, filed with the SEC on August 31, 2017.October 6, 2020.

18

 

Information regarding our accounting policies and estimates can be found in the Notes to the consolidated Financial Statements.

 

Newly Issued Accounting Pronouncements

 

Information regarding the recently issued accounting standards (adopted and pending adoption as of DecemberMarch 31, 2017) is combined2021are presented in Note 1 to the condensed consolidated financial statements.

 

RESULTS OF OPERATIONS

 

Results of Operations DecemberThree and Nine Months Ended March 31, 2017 Compared2021 compared to Decemberthe Three and Nine Months Ended March 31, 20162020

 

  

Three months Ended March 31,

         
  

2021

  

2020

  

Change

  % 
                 

Revenues

                

Product and service revenue, net

 $13,482,282  $8,156,173  $5,326,109   65%

Operating expenses

                
Cost of sales  13,682,297   1,998,659   11,683,638   585%

Research and development

  389,262   78,502   310,760   396%

Selling, general and administrative

  12,851,087   9,190,386   3,660,701   40%
Acquisition related costs  1,536,800   311,083   1,225,717   394%
Restructuring costs  4,818,064    −   4,818,064    

Amortization and impairment of intangible assets

  5,870,436   1,370,986   4,499,450   328%

Total operating expenses

  39,147,946   12,949,616   26,198,330   202%

Loss from operations

  (25,665,664)  (4,793,443)  (20,872,221)  435%

Other (expense) income

                

Other (expense), net

  (425,425)  (538,862)  113,437   -21%

Loss from change in fair value of contingent consideration

  631,298   -   631,298    
Total other (expense) income  205,873   (538,862)  744,735   -138%
Net loss $(25,459,791) $(5,332,305) $(20,127,486)  377%

Results of operations for the three months ended December 31, 2017 and the three months ended December 31, 2016 reflected losses of approximately $3.7 million and $4.8 million, respectively. These losses include, in part, non-cash charges related to stock-based compensation, depreciation, amortization and accretion, issuance of restricted stock, unrealized gain on investment, and derivative income, in the amount of $256,000 for the three months ended December 31, 2017 and $1.6 million for the three months ended December 31, 2016, respectively. The non-cash charges decreased in the three months ended 2017 primarily due to the decrease in stock-compensation expense and amortization and impairment expenses.

  

Nine Months Ended March 31,

         
  

2021

  

2020

  

Change

  

%

 
                 

Revenues

                

Product and service revenue, net

 $42,149,561  $12,771,235  $29,378,326   230%

Operating expenses

                

Cost of sales

  23,499,842   2,980,425   20,519,417   688%

Research and development

  858,698   223,197   635,501   285%

Selling, general and administrative

  35,825,175   19,494,368   16,330,807   84%
Acquisition related costs  2,849,037   1,533,723   1,315,314   86%
Restructuring costs  4,874,723   135,981   4,738,742   3485%

Amortization and impairment of intangible assets

  9,039,597   2,899,553   6,140,044   212%

Total operating expenses

  76,947,072   27,267,247   49,679,825   182%

Loss from operations

  (34,797,511)  (14,496,012)  (20,301,499)  140%

Other (expense) income

                

Other (expense), net

  (1,555,924)  (1,181,206)  (374,718)  32%

Loss from change in fair value of contingent consideration

  (2,680,022)   −   (2,680,022)   

Gain from derecognition of contingent consideration

   −   5,199,806   (5,199,806)  -100%

Gain from warrant derivative liability

   −   1,830   (1,830)  -100%

Loss on debt exchange

  (257,559)   −   (257,559)   

Total other (expense) income

  (4,493,505)  4,020,430   (8,513,935)  -212%

Net loss

 $(39,291,016) $(10,475,582) $(28,815,434)  275%

 

Results of operations for the six months ended December 31, 2017 and the six months ended December 31, 2016 reflected losses of approximately $7.9 million and $10.5 million, respectively. These losses include in part non-cash charges related to stock-based compensation, depreciation, amortization and accretion, compensation through issuance of stock, issuance of warrants to initial investors, and amortization of prepaid research and development offset by an unrealized gain on investment and warrant derivative income in the amount of $877,000 for the six months ended December 31, 2017 and $4.0 million for the six months ended December 31, 2016, respectively. The non-cash charges decreased in the six months ended 2017 primarily due to decrease in stock-compensation expense and depreciation, amortization and accretion expense. 

Revenue

Product revenuerevenue.

We recognized net revenue from product sales of $1.1approximately $13.5 million and $794,000$8.2 million for the three months ended DecemberMarch 31, 20172021 and 2016,2020, respectively. We recognized net revenue from product sales of $2.1 millionapproximately $42.1 and $1.5$12.8 million for the sixnine months ended DecemberMarch 31, 20172021 and 2016,2020, respectively. OurThe increase was primarily driven by the acquisitions of the Pediatric Portfolio on November 1, 2019, the Consumer Health Portfolio on February 14, 2020 and the ADHD product portfolio includes Natesto, ProstaScint, Primsol, Fiera, and the MiOXSYS and RedoxSYS Systems, but the majority of our revenue comes from Natesto sales. Revenue from Natesto increased 429% in the second quarter of fiscal 2018 compared to the same quarter in fiscal 2017, and increased 281% for the six months ended December 31, 2017 compared to the six months ended December 31, 2016.

19

As is customary in the pharmaceutical industry, our gross product sales are subject to a variety of deductions in arriving at reported net product sales. Provisions for these deductions are recorded concurrently with the recognition of gross product revenue and include discounts, chargebacks, distributor fees, processing fees,Neos on March 19, 2021, as well as allowances for returnsadditional revenues from COVID-19 test kit sales. Due to our entry on March 31, 2021 into a termination and Medicaid rebates. Provision deductions relatingtransition agreement with Acerus Pharmaceuticals Corporation terminating the License and Supply Agreement related to estimated amounts payableNatesto, we will no longer recognize revenue related to direct customers are netted against accounts receivable and balances relating to indirect customers are included in accounts payable and accrued liabilities. The provisions recorded to reduce gross product sales to net product sales areNatesto as follows:of April 1, 2021.  

 

  Three Months Ended December 31,  Six Months Ended December 31, 
  2017  2016  2017  2016 
       
Gross product revenue $2,028,000  $1,358,000  $4,272,000  $2,284,000 
Provisions to reduce gross product sales to net product sales  (977,000)  (564,000)  (2,144,000)  (792,000)
Net product revenue $1,051,000  $794,000  $2,128,000  $1,492,000 
                 
Percentage of gross sales to net sales  51.8%  58.5%  49.8%  65.3%

Expenses

Cost of Salessales

.

TheWe incurred cost of sales of $385,000$13.7 million and $551,000$2.0 million recognized for the three months ended DecemberMarch 31, 20172021 and 2016, respectively, and2020, respectively. We incurred the cost of sales of $673,000$23.5 million and $743,000 recognized$3.0 million for the sixnine months ended DecemberMarch 31, 20172021 and 2016, respectively are related to Natesto, ProstaScint, Primsol, Fiera2020, respectively. The increase was primarily driven by the acquisitions of the Pediatric Portfolio on November 1, 2019, Consumer Health Portfolio on February 14, 2020 and Neos on March 19, 2021, as well as additional sales from COVID-19 test kit sales. In addition, we recognized approximately $7.0 million in write-downs for slow moving inventory during the MiOXSYSthree-months ended March 31, 2021. Neos manufactures the ADHD products at its Grand Prairie, Texas facilities, and RedoxSYS Systems. We expectas such, allocates a significant portion of its intangible assets amortization and fixed assets depreciation into cost of sales to increase in the fiscal year 2018 due to and in line with growth in revenue from product sales.

Research and DevelopmentDevelopment.

Research and development costs consist of clinical trials and sponsored research, manufacturing transfer expense, sponsored research – related party and consultants and other. These costs relate solely to research and development without an allocation of general and administrative expenses and are summarized as follows:

  Three Months Ended December 31,  Six Months Ended December 31, 
  2017  2016  2017  2016 
       
Clinical trials and sponsored research $(278,000) $262,000  $(139,000) $493,000 
Sponsored research - related party  -   48,000   -   96,000 
Consultants and other  1,000   1,000   2,000   2,000 
  $(277,000) $311,000  $(137,000) $591,000 

Comparison of Three and Six Months Ended December 31, 2017 and 2016

Research and development expenses decreased $588,000,increased $0.3 million, or 189.1%396%, for the three months ended DecemberMarch 31, 20172021, compared to the three months ended DecemberMarch 31, 2016.2020. Research and development expenses decreased $727,000,increased approximately $0.6 million, or 123.0%,285% for the sixnine months ended DecemberMarch 31, 20172021, compared to the sixnine months ended DecemberMarch 31, 2016.2020. The declineincrease was due primarily to switchingcosts associated with our focusHealight Platform license and resource commitment to our commercial products;initial research and development costs, as well as our decisionthe acquisition of Neos on March 19, 2021, which incurs costs related to discontinue sales of ProstaScint mid-fiscal 2019 upon expiration of the product for which we reversed a previously accrued liability in the amount of $398,000. We anticipate researchdevelopment and development expense to decrease in fiscal 2018 as compared to fiscal 2017 as we continue to focus on our commercial products.FDA-required post-marketing clinical trials.

 

20

Selling, General and AdministrativeAdministrative.

Selling, general and administrative expenses consist of labor costs, including personnel costs for employees in executive, commercial, business development and operational functions; stock-based compensation; patents and intellectual property; professional fees including legal, auditing, accounting, investor relations, shareholder expense and printing and filing of SEC reports; occupancy, travel and other expenses including rent, governmental and regulatory compliance, insurance, and professional subscriptions; and directors fees. These costs are summarized as follows:

  Three Months Ended December 31,  Six Months Ended December 31, 
  2017  2016  2017  2016 
       
Labor $2,371,000  $1,775,000  $4,772,000  $4,030,000 
Stock-based compensation  112,000   463,000   379,000   1,582,000 
Patent costs  107,000   29,000   235,000   55,000 
Professional fees  312,000   248,000   731,000   510,000 
Occupancy, travel and other  1,611,000   1,087,000   2,975,000   3,090,000 
Directors Fees  40,000   40,000   80,000   80,000 
Management fee - related party  -   51,000   -   102,000 
  $4,553,000  $3,693,000  $9,172,000  $9,449,000 

Comparison of Three and Six Months Ended December 31, 2017 and 2016

Selling, general and administrative costs increased $860,000,$3.7 million, or 23.3%40%, for the three months ended DecemberMarch 31, 2017,2021 compared to the three months ended DecemberMarch 31, 2016. General2020. Selling, general and administrative costs decreased $277,000increased $16.3 million, or 2.9%,approximately 84% for the sixnine months ended DecemberMarch 31, 2017 compared to the six months ended December 31, 2016.2021. The primary increase was primarily due to acquisitions of the Pediatric Portfolio, Innovus and Neos that occurred in laborthe prior year ended June 30, 2020, of which, only the Pediatric Portfolio was a component of our financial results for November and December of 2019. The remaining portion of the Neos intangible assets amortization and fixed assets depreciation not allocated into cost and occupancy, travel and other which was relatedof sales is allocated to the increase in commercial department staffing during the six months ended December 31, 2017 as compared to the six months ended December 31, 2016. We expect selling, general and administrative expenses to be approximately flat for the remainder of fiscal 2018.expense.

 

Amortization and impairment of Intangible AssetsAssets.

Amortization expense of intangible assets was $384,000approximately $5.9 million and $437,000$1.4 million for the for the three months ended DecemberMarch 31, 2017, compared2021 and 2020, respectively. Amortization expense of intangible assets was approximately $9.0 million and $2.9 million for the nine months ended March 31, 2021 This expense is related to corresponding amortization of our finite-lived intangible assets. The increase of this expense is due primarily to the $4.3 million write-off of licensed intangible asset related to the March 30, 2021 Natesto divestiture and the Pediatric Portfolio acquisition from Cerecor and Innovus Merger that occurred in the fiscal year ended June 30, 2020..

Acquisition related costs. We incurred acquisition related costs of $1.5 million and $2.8 million during the three and nine months ended March 31, 2021 related to the Neos Merger. During the three and nine months ended March 31, 2020, we incurred acquisition costs of $0.3 million and $1.5 million related to the Innovus Merger. Such costs include legal fees and due diligence expenses and financial advisory fees.

Restructuring costs. We incurred severance costs of $4.8 million and $4.9 million during the three and nine months ended March 31, 2021, respectively, primarily related to the Neos Merger. We incurred severance costs of $0.1 million during the nine month ended March 31, 2020 related to reduction in forces. There were no such costs incurred in during the three months ended DecemberMarch 31, 2016. Amortization of intangible assets was $770,000 and $874,0002020.

Interest (expense) income, net. Interest (expense) income, net for the sixthree months ended DecemberMarch 31, 20172021 was expense of approximately $0.4 million, compared to expense of $0.5 million for the sixthree months ended DecemberMarch 31, 2016. This2020. Interest (expense) income, net for the nine months ended March 31, 2021 was expense decreasedof approximately $1.6 million, compared to interest expense of $1.2 million for the three months ended March 31, 2020. The increase was primarily due to the impairmentaccretion and interest expense resulting from the assumed fixed payment obligations and other long-term liabilities that arose from the (i) November 1, 2019 acquisition of the ProstaScintPediatric Portfolio from Cerecor, Inc., (ii) the February 14, 2020, Merger with Innovus and (iii) the March 19, 2021, Merger with Neos.

Loss from change in fair value of contingent consideration. We recognized a gain of approximately $0.7 million from the change in the fair value of the ZolpiMist and Tuzistra contingent consideration liability and a loss of approximately $0.1 million from the change in fair value of the contingent value rights ("CVR's") liability related to the Innovus Merger during the three months ended March 31, 2021. During the nine months ended March 31, 2021, we recognized a loss of approximately $1.7 million from the change in the fair value of the ZolpiMist and Tuzistra contingent consideration liability and a loss of approximately $1.0 million from the change in fair value of the contingent value rights ("CVR's") liability related to the Innovus Merger.

Liquidity and Capital Resources

As of March 31, 2021, we had approximately $46.8 million of cash, cash equivalents and restricted cash. Our operations have historically consumed cash and are expected to continue to require cash, but at a declining rate.

Revenues for the three and nine months ended March 31, 2021 were approximately $13.5 million and $42.1 million, compared to $8.2 million and $12.8 million for the same periods ended March 31, 2020, an increase of 65% and 230%, respectively. Revenue is expected to increase over time, which will allow us to rely less on our existing cash balance and proceeds from financing transactions. Cash used by operations during the three and nine months ended March 31, 2021 was $19.7 million compared to $20.6 million for the three and nine months ended March 31, 2020. The decrease is due primarily to a decrease in working capital and pay down of other liabilities.

As of the date of this report, we expect costs of operations to increase as we integrate the Neos acquisition, invest in new product candidate development and continue to focus on revenue growth through increasing product sales. Our current assets in fiscal 2017,totaling approximately $100.0 million as of March 31, 2021, plus the proceeds expected from ongoing product sales will be used to fund existing operations. We may continue to access the capital markets from time-to-time when market conditions are favorable. The timing and amount of capital that may be raised is dependent the terms and conditions upon which investors would require to provide such capital. There is no guarantee that capital will be available on terms favorable to us and our stockholders, or at all. We raised approximately $29.6 million, net during the nine months ended March 31, 2021, from the sale of approximately 0.4 million shares using our at-the-market facility and from the issuance of approximately 4.8 million shares of our common stock and 0.3 million placement agent warrants on the December 15, 2020 offering. Finally, on December 10, 2020, we exchanged $0.8 million of debt into 0.1 million shares of our common stock, reducing the need to use cash to satisfy this obligation. Between March 31, 2021, and the corresponding amortizationfiling date of its finite-lived intangible assets. We expect this expensequarterly report on Form 10-Q, we have not issued any common stock under our at-the-market offering program. As of the date of this report, we have adequate capital resources to remain flatcover potential net cash outflows for the remaindertwelve months following the filing date of 2018.this Quarterly Report.

 

If we are unable to raise adequate capital in the future when it is required, we can adjust our operating plans to reduce the magnitude of the capital needs under our existing operating plan. Some of the adjustments that could be made include delays of and reductions to commercial programs, reductions in headcount, narrowing the scope of our commercial plans, or reductions or delay to our research and development programs. Without sufficient operating capital, we could be required to relinquish rights to products or renegotiate to maintain such rights on less favorable terms than it would otherwise choose. This may lead to impairment or other charges, which could materially affect our balance sheet and operating results.

The following table shows cash flows for the three months ended March 31, 2021 and 2020:

  

Nine Months Ended March 31,

 
  

2021

  

2020

 

Net cash used in operating activities

 $(19,677,832) $(20,609,198)

Net cash used in investing activities

 $(364,094) $(5,610,732)

Net cash provided by financing activities

 $18,498,572  $77,441,786 

Net Cash Used in Operating Activities

During the six monthsnine-months ended DecemberMarch 31, 2017,2021, our operating activities used $7.3$19.7 million in cash, which was less than the reported net loss of $7.9 million. Our cash use was lower than our reported net loss$34.2 million, primarily due to an increase in accounts payablea $7.2 write-down related to inventory, and accrued compensation expense, with the recognition ofother non-cash expensesadjustments such as depreciation, amortization and accretion, stock-based compensation, and stock-basedloss from change in fair value of contingent consideration and CVR, decreases in accounts receivable, prepaid expenses, other current assets and an increase in accrued compensation. These charges were offset by derivative income, an increase in inventory and decreases in accounts receivablepayable and prepaid expenses, and a decrease in accrued liabilities.

 

During the six monthsnine-months ended DecemberMarch 31, 2016,2020, our operating activities used $8.2$20.6 million in cash, which was lessgreater than the net loss of $10.5 million, primarily as a result of derecognition of contingent consideration and an increase in accounts receivable, offset by the non-cash depreciation, amortization and accretion, and stock-based compensation expenses offset bycharges to earnings, coupled with an increase in accounts receivable, a decrease in accounts payable and accrued liabilities, and accrued compensation.payable.

 

Net Cash Used in Investing Activities

During the six months ended December 31, 2017, we used $12,000 in investing activities to purchase fixed assets.

 

During the six monthsnine-months ended DecemberMarch 31, 2016,2021, we made a payment of $0.2 million to acquire Neos, net of cash acquired, and paid $0.7 million in contingent consideration.

During the nine-months ended March 31, 2020, we used $1.4 million for the Innovus Merger. We also used $4.5 million for the Cerecor acquisition and we paid $0.2 million in contingent consideration offset by cash in investing activities of $2.8$0.4 million $45,000 of which was used to purchase fixed assets, $750,000 of which was paid as the second and third installments towards the Primsol asset and $2.0 million of which was paid as the second installment payment of our Natesto licensing agreement. received from Innovus Merger.

 

Net Cash from Financing Activities

Net cash provided by financing activities in the six months ended December 31, 2017 of $10.4 million was primarily related to the private offering of $11.8 million, offset by the offering cost of $1.4 million which was paid in cash.

 

Net cash provided by financing activities in the six monthsnine-months ended DecemberMarch 31, 2016 of $8.2 million2021 was $18.6 million. This was primarily related to the registeredDecember 2020 offering for gross proceeds cost of $8.6$28.8 million offset by the cash offering cost of $998,000 and$2.6 million. We also issued shares of our common stock issuanceunder the ATM with gross proceeds of $631,000$3.6 million, which was offset by commission and other offering cost of $1.6 million. We paid approximately $6.0 million on our short-term line of credit, $3.0 million related to fixed payment obligation and $0.3 million of debt. 

Net cash provided by financing activities in the nine-months ended March 31, 2020 was $77.4 million. This was primarily related to the (i) October 2019 Offering for gross proceeds of $10.0 million, offset by the issuanceoffering cost of $0.7 million which was paid in cash; (ii) $49 million raised in the March 2020 Offerings, offset by offering costs of $24,000 paid to Lincoln Park.approximately $4.5 million, and (iii) $23.0 million raised as the result of warrant exercises in March 2020.

 

21

Liquidity and Capital Resources

We are a relatively young company with substantial revenue growth expectations as demonstrated by the nearly 32% year-over-year revenue growth for the three months ended December 31, 2017. Our primary activities are focused on commercializing our approved product portfolio, including Natesto, building our commercial infrastructure, improving access to payor formularies and improving the effectiveness and reach of our sales force. As of December 31, 2017, we had cash, cash equivalents and restricted cash totaling $4.0 million and other current assets with an aggregate balance of $3.8 million available to fund our operations, offset by an aggregate of $3.7 million in accounts payable and accrued liabilities.

Based on our existing cash and current asset balance and considering our trend of increasing revenue and the sequential decline in cash used by operations, we believe we have sufficient resources to fund our operations into the fourth quarter of fiscal 2018. We believe that our sales will continue to grow and that our efforts and programs designed to reduce discounting of Natesto will combine to reduce the rate of cash use. We expect to maintain research and development and selling, general and administrative costs, at levels comparable to the quarter ended December 31, 2017. With these assumptions, we believe that we have sufficient cash resources to fund operations for several months, after which time we expect to require additional new capital. We will seek to raise additional capital at such time as we conclude that capital is available on terms that we consider to be in the best interests of our Company and our stockholders. If we cannot raise adequate additional capital in the future when we require it, we could be required to delay, reduce the scope of, or eliminate one or more of our commercialization efforts or our research and development programs. We also may be required to relinquish greater or all rights to product candidates at less favorable terms than we would otherwise choose. This may lead to impairment or other charges, which could materially affect our balance sheet and operating results. However, since our common stock became listed on the NASDAQ stock market in October 2017, the universe of investors whose investment charters allow for an investment in us has increased. Additionally, due to recent announcements by an FDA advisory committee voting against allowing new product entries in the TRT market in which Natesto competes, we believe investor interest in us will increase. As a result of these recent developments, and considering the increase in trading volume in our common stock over the past 60 days, we believe that more investors may be interested in owning our securities (see Note 11).

Off Balance Sheet Arrangements

We do not have off-balance sheet arrangements, financings, or other relationships with unconsolidated entities or other persons, also known as “variable interest entities.”

 

Item 3.Quantitative and Qualitative Disclosures About Market Risk.

Contractual Obligations and Commitments

Information regarding our Contractual Obligations and Commitments is contained in Note 10 to the Financial Statements.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

 

We are not currently exposed to material market risk arising from financial instruments, changes in interest rates or commodity prices, or fluctuations in foreign currencies. We have not identified a need to hedge against any of the foregoing risks and therefore currently engagesengage in no hedging activities.

 

Item 4.Controls and Procedures.

Item 4. Controls and Procedures.

 

As of the end of the period covered by this Quarterly Report on Form 10-Q, an evaluation was carried out by our management, with the participation of the Chief Executive Officer and Chief Financial Officer, of the effectiveness of our disclosure controls and procedures, as defined in Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act. Based on such evaluation, the Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures are effective to ensure that information required to be disclosed in the reports we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, and are operating in an effective manner.

 

Changes in Internal Control over Financial Reporting

 

There were no changes in our internal controls over financial reporting, except as described below, known to the Chief Executive Officer or the Chief Financial Officer that occurred during the last fiscal quarterperiod covered by this Report that hashave materially affected, or isare reasonably likely to materially affect, our internal control over financial reporting.

 

22

Our assessment of in our internal controls over financial reporting excluded those processes or controls that exist at our Aytu Consumer Health reporting unit, which we acquired from the February 14, 2020. Those controls related to the Innovus Merger are being evaluated internally, and any changes as a result of that evaluation will be disclosed in future filings. 

 

 

PART II. OTHER INFORMATION

 

Item  1.Legal Proceedings.

Item 1. Legal Proceedings.

Harris and Walker County. On March 7, 2018 and April 18, 2019, Neos received citations advising Neos that the County of Harris Texas (“Harris County”) and the County of Walker Texas (“Walker County”) filed lawsuits on December 13, 2017 and January 11, 2019, respectively, against Neos and various other alleged manufacturers, promoters, sellers and distributors of opioid pharmaceutical products. Through these lawsuits, each of Harris County and Walker County seek to recoup as damages some of the expenses they allegedly have incurred to combat opioid use and addiction. Each of Harris County and Walker County also seeks punitive damages, disgorgement of profits and attorneys’ fees.

Merger Action. On Between January 27, 2021 and February 25, 2021, nine lawsuits were filed related to the Neos Merger; on January 27, 2021, Wang v. Neos Therapeutics, Inc., et al., 1:21-cv-00095, was filed by purported Neos stockholder Elaine Wang against Neos and its directors in the U.S. District Court for the District of Delaware; on January 29, 2021, Dupree v. Neos Therapeutics, Inc., et al., 1:121-cv-00124, was filed by purported Neos stockholder Michael Dupree against Neos, its directors, the Merger Sub, and Aytu in the U.S. District Court for the District of Delaware; on February 1, 2021, London v. Neos Therapeutics, Inc., et al., 1:21-cv-00874, was filed by purported Neos stockholder Jack London against Neos and its directors in the U.S. District Court for the Southern District of New York; on February 3, 2021, Kates v. Neos Therapeutics, Inc., et al., 1:21-cv-00953, was filed by purported Neos stockholder Erin Kates against Neos and its directors in the U.S. District Court for the Southern District of New York; on February 3, 2021, Smith v. Neos Therapeutics, Inc., et al., 1:21-cv-00940, was filed by purported Neos stockholder Hayley Smith against Neos, its directors, the Merger Sub, and Aytu in the U.S. District Court for the Southern District of New York; on February 9, 2021, Tkatch v. Neos Therapeutics, Inc., et al., 1:21-cv-01187, was filed by purported Neos stockholder Natalia Tkatch against Neos and its directors, the Merger Sub, and Aytu in the U.S. District Court for the Southern District of New York; on February 16, 2021, Bushansky v. Neos Therapeutics, Inc., et al., 1:121-cv-00208, was filed by purported Neos stockholder Stephen Bushansky against Neos and its directors in the U.S. District Court for the District of Delaware; on February 16, 2021, Wheeler v. Neos Therapeutics, Inc., et al., 1:121-cv-00213, was filed by purported Neos stockholder Jacob Wheeler against Neos and its directors in the U.S. District Court for the District of Delaware; on February 25, 2021, Hein v. Neos Therapeutics, Inc., et al., 1:121-cv-00287, was filed by purported Neos stockholder Matthew Hein against Neos and its directors in the U.S. District Court for the District of Delaware. The London, Kates,Tkatch, Dupree and Wang cases were subsequently dismissed.

Item 1A. Risk Factors.

In addition to other information set forth in this report, you should carefully consider the risk factors discussed in Part I, Item 1A. “Risk Factors” in our Annual Report, which could materially affect our business, financial condition, cash flows, and/or future results. The risk factors in our Annual Report are not the only risks facing our Company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition, and/or future results. There are no additional risk factors other than those contained in our Annual Report.

RISKS RELATED TO OUR BUSINESS AND FINANCIAL POSITION

Our business and operations would suffer in the event of system failures.

We utilize information technology, or IT, systems and networks to process, transmit and store electronic information in connection with our business activities. As use of digital technologies has increased, cyber incidents, including deliberate attacks and attempts to gain unauthorized access to computer systems and networks, have increased in frequency and sophistication. These threats pose a risk to the security of our systems and networks and the confidentiality, availability and integrity of our data. There can be no assurance that we will be successful in preventing cyber‑attacks or successfully mitigating their effects.

Despite the implementation of security measures, our internal computer systems and those of our contractors and consultants are vulnerable to damage from such cyber attacks, including computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. Such an event could cause interruption of our operations. For example, the loss of data from completed clinical trials for our product candidates could result in delays in our regulatory approval efforts and significantly increase our costs. To the extent that any disruption or security breach were to result in a loss of or damage to our data, or inappropriate disclosure of confidential or proprietary information, we could suffer reputational harm or face litigation or adverse regulatory action and the development of our product candidates could be delayed.

RISKS RELATED TO COMMERCIALIZATION

The design, development, manufacture, supply and distribution of our products and product candidates are highly regulated processes and technically complex.

 

We are subject to extensive regulation in connection with the preparation and manufacture of our products for commercial sale. Components of a finished therapeutic product approved for commercial sale or used in late‑stage clinical trials must be manufactured in accordance with cGMPs and equivalent foreign standards. These regulations govern manufacturing processes and procedures, including record keeping, and the implementation and operation of quality systems to control and assure the quality of investigational products and products approved for sale. Poor control of production processes can lead to the introduction of adventitious agents or other contaminants, or to inadvertent changes in the properties or stability of our products and product candidates that may not be detectable in final product testing. The development, manufacture, supply and distribution of our approved products as well as any of our future potential product candidates, are highly regulated processes and technically complex. We, along with our third‑party suppliers, must comply with all applicable regulatory requirements of the FDA and foreign authorities. For instance, because each of our attention deficit/hyperactivity disorder (“ADHD”) products, generic Tussionex, Tuzistra XR, and ZolpiMist is a regulated drug product and subject to the U.S. Drug Enforcement Administration (“DEA”) and state-level regulations, we have had to, and will continue to, need to secure state licenses from each state in which we intend to sell such product allowing us to distribute a regulated drug product in such state.

Regulatory authorities also may, at any time following approval of a product for sale, audit our manufacturing facilities. If any such inspection or audit identifies a failure to comply with applicable regulations or if a violation of our product specifications or applicable regulations occurs independent of such an inspection or audit, we or the relevant regulatory authority may require remedial measures that may be costly and/or time‑consuming for us to implement and that may include the temporary or permanent suspension of a clinical trial or commercial sales or the temporary or permanent closure of our facility. Any such remedial measures imposed upon us could materially harm our business. If we fail to maintain regulatory compliance, the FDA can impose regulatory sanctions including, among other things, refusal to approve a pending application for a new drug product or revocation of a pre‑existing approval. As a result, our business, financial condition and results of operations may be materially harmed.

We rely on limited sources of supply for our ADHD products and our generic Tussionex, and any disruption in the chain of supply may impact production and sales of our ADHD products and our generic Tussionex, and cause delays in developing and commercializing our product candidates and currently manufactured and commercialized products.

Our approved NDAs for our ADHD products, include our proposed manufacturing process for each product. Any change to our manufacturing process, facilities or suppliers could require that we supplement our approved NDA. Also, because of our proprietary processes for manufacturing our product candidates, we cannot immediately transfer manufacturing activities for our ADHD products or our generic Tussionex to an alternate supplier, and a change of facilities would be a time‑consuming and costly endeavor.

Any changes to our manufacturing process would involve substantial cost and could result in a delay in our desired clinical and commercial timelines. We are also reliant on a limited number of suppliers for resin, drug compounds, coating and other component substances of our final product candidates and products. If any of these single‑source suppliers were to breach or terminate its supply agreement, if any, with us or otherwise not supply us, we would need to identify an alternative source for the supply of component substances for our product candidates and products. Identifying an appropriately qualified source of alternative supply for any one or more of the component substances for our product candidates or products could be time consuming, and we may not be able to do so without incurring material delays in the development and commercialization of our approved products or product candidates or a decrease in sales of our approved products, which could harm our financial position and commercial potential for our product candidates and products. Any alternative vendor would also need to be qualified through an NDA supplement which could result in further delay, including delays related to additional clinical trials. The FDA, DEA, or other regulatory agencies outside of the United States may also require additional studies if we enter into agreements with new suppliers for the manufacture of our ADHD products and our generic Tussionex that differ from the suppliers used for clinical development of such product candidates.

These factors could cause the delay of clinical trials, regulatory submissions, required approvals or commercialization of our products and product candidates, cause us to incur higher costs and prevent us from commercializing them successfully. Furthermore, if our suppliers fail to deliver the required commercial quantities of components and APIs on a timely basis and at commercially reasonable prices, including if our suppliers did not receive adequate DEA quotas for the supply of certain scheduled components, and we are unable to secure one or more replacement suppliers capable of production at a substantially equivalent cost, commercialization of our ADHD products, our generic Tussionex and clinical trials of future potential product candidates, may be delayed or we could lose potential revenue and our business, financial condition, results of operation and reputation could be adversely affected.

If we fail to produce our products or product candidates in the volumes that are required on a timely basis, we may face penalties from wholesalers and contracted retailers of our products and delays in the development and commercialization of our product candidates.

We currently depend on third‑party suppliers for the supply of the APIs for our products and product candidates, including drug substance for nonclinical research, clinical trials and commercialization. For our ADHD products, our generic Tussionex and NT0502, our product candidate for sialorrhea, we currently rely on single suppliers for raw materials including APIs, which we use to manufacture, produce and package final dosage forms. In particular, we have an exclusive supply agreement with Coating Place, Inc. (“CPI”), pursuant to which CPI (i) is the exclusive supplier of the active ingredient complexes in our generic Tussionex and (ii) has agreed to not supply anyone else engaged in the production of generic Tussionex with such active ingredient complexes. Any future curtailment in the availability of raw materials could result in production or other delays with consequent adverse effects on us. In addition, because regulatory authorities must generally approve raw material sources for pharmaceutical products, changes in raw material suppliers may result in production delays or higher raw material costs. We are subject to penalties from wholesalers and contracted retailers if we do not deliver our generic Tussionex and ADHD products in quantities that meet their demand. Any such delays could trigger these penalty provisions, which would have a negative impact on our business.

If we fail to manufacture our ADHD in sufficient quantities and at acceptable quality and pricing levels, or fail to obtain adequate DEA quotas for controlled substances, or to fully comply with cGMP regulations, we may face delays in the commercialization of these products or our product candidates, if approved, or be unable to meet market demand, and may be unable to generate potential revenues.

The manufacture of pharmaceutical products requires significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls, and the use of specialized processing equipment. Pharmaceutical companies often encounter difficulties in manufacturing, particularly in scaling up production of their products. These problems include manufacturing difficulties relating to production costs and yields, quality control, including stability of the product and quality assurance testing, shortages of qualified personnel, as well as compliance with federal, state and foreign regulations. If we are unable to demonstrate stability in accordance with commercial requirements, or if our raw material manufacturers were to encounter difficulties or otherwise fail to comply with their obligations to us, our ability to obtain FDA approval and market our products and product candidates would be jeopardized. In addition, any delay or interruption in the supply of clinical trial supplies could delay or prohibit the completion of our clinical trials, increase the costs associated with conducting our clinical trials and, depending upon the period of delay, require us to commence new trials at significant additional expense or to terminate a trial. We purchase raw materials and components from various suppliers in order to manufacture our ADHD products. If we are unable to source the required raw materials from our suppliers, or if we do not obtain DEA quotas or receive inadequate DEA quotas, we may experience delays in manufacturing our ADHD products, and may not be able to meet our customers’ demands for our products.

In addition, we must comply with federal, state and foreign regulations, including cGMP requirements enforced by the FDA through its facilities inspection program. These requirements include, among other things, quality control, quality assurance and the maintenance of records and documentation. We may be unable to comply with these cGMP requirements and with other FDA and foreign regulatory requirements. A failure to comply with these requirements may result in fines and civil penalties, suspension of production, suspension or delay in product approval, product seizure or voluntary recall, or withdrawal of product approval. If the safety of any of our products or product candidates is compromised due to failure to adhere to applicable laws or for other reasons, we may not be able to obtain, or to maintain once obtained, regulatory approval for such products or product candidates or successfully commercialize such products or product candidates, and we may be held liable for any injuries sustained as a result. Any of these factors could cause a delay in clinical development, regulatory submissions, approvals or commercialization of our products or product candidates, entail higher costs or result in our being unable to effectively commercialize our products or product candidates. Any manufacturing defect or error discovered after products have been produced and distributed could result in even more significant consequences, including costly recall procedures, re-stocking costs, damage to our reputation and potential for product liability claims.

Our Grand Prairie facility was formerly operated by our predecessor, PharmaFab, Inc., or PharmaFab. In April 2007, the FDA announced entry of a Consent Decree of Permanent Injunction, or the Consent Decree, against PharmaFab, one of its subsidiaries and two of its officials. The Consent Decree arose out of several perceived cGMP deficiencies related to the manufacture of unapproved drugs or Drug Efficacy Study Implementation drugs that we no longer manufacture. In July 2019, we filed a motion with the U.S. District Court of North Texas to vacate the Consent Decree, which was unopposed by the Department of Justice and the FDA and was granted by the court on July 11, 2019. While the Consent Decree has been vacated, there can be no assurance that we will not become subject to similar orders in the future, which may result in us continuing to expend resources and attention to observe its terms, and there can be no assurance that we will be in compliance with its requirements.

If our sole manufacturing facility becomes damaged or inoperable or we decide to or are required to vacate our facility, our ability to manufacture our ADHD products, our generic Tussionex or future potential product candidates for clinical development, may be jeopardized. Our inability to continue manufacturing adequate supplies of our products could adversely affect our ability to generate revenues.

All of our manufacturing capabilities are housed in our sole manufacturing facility located in Grand Prairie, Texas. Our facility and equipment could be harmed or rendered inoperable by natural or man‑made disasters, including war, fire, tornado, power loss, communications failure or terrorism, any of which may render it difficult or impossible for us to operate our drug delivery technology platform and manufacture our product candidates or products for some period of time. While we seek to maintain finished goods inventory of our products outside of this facility, it is unlikely that the level of such inventory would be sufficient if we were to sustain anything other than a short-term disruption in our ability to manufacture our products and product candidates at our Grand Prairie, Texas facility. The inability to manufacture our products and product candidates if our facility or our equipment is inoperable, for even a short period of time, may result in the loss of customers or harm to our reputation, and we may be unable to regain those customers or repair our reputation in the future. Furthermore, our facility and the equipment we use to manufacture our products and product candidates could become damaged and time‑consuming to repair or replace. It would be difficult, time‑consuming and expensive to rebuild our facility or repair or replace our equipment or license or transfer our proprietary technology to a third‑party, particularly in light of the requirements for a DEA‑registered manufacturing and storage facility like ours. If we decide to or are required to change or add a new manufacturer or supplier, the process would likely require prior FDA, DEA and/or equivalent foreign regulatory authority approval, and would be time consuming and costly. Even in the event we are able to find a third party with such qualifications to enable us to manufacture our products or product candidates, we may be unable to negotiate commercially reasonable terms.

We carry insurance for damage to our property and the disruption of our business, but this insurance may not cover all of the risks associated with damage or disruption to our business, may not provide coverage in amounts sufficient to cover our potential losses and may not continue to be available to us on acceptable terms, if at all. An inability to continue manufacturing adequate supplies of our ADHD products or our generic Tussionex at our Grand Prairie, Texas facility could result in a disruption in the supply of our products to physicians and pharmacies, which would adversely affect our ability to generate revenues.

Amphetamine, methylphenidate and hydrocodone are ScheduleII controlled substances under the Controlled Substances Act, and any failure to comply with this Act or its state equivalents would have a negative impact on our business.

Amphetamine, methylphenidate and hydrocodone, which are the active ingredients in our Adzenys XR-ODT, Adzenys ER, Cotempla XR-ODT and generic Tussionex products, are listed by the DEA as a Schedule II controlled substance under the Controlled Substances Act (“CSA”). The DEA classifies substances as Schedule I, II, III, IV or V controlled substances, with Schedule I controlled substances considered to present the highest risk of substance abuse and Schedule V controlled substances the lowest risk. Scheduled controlled substances are subject to DEA regulations relating to supply, procurement, manufacturing, storage, distribution and physician prescription procedures. For example, Schedule II controlled substances are subject to various restrictions, including, but not limited to, mandatory written prescriptions and the prohibition of refills. In addition to federal scheduling, some drugs may be subject to state‑controlled substance laws and regulations and more extensive requirements than those determined by the DEA and FDA. Though state controlled substances laws often mirror federal law, because the states are separate jurisdictions, they may schedule products separately. While some states automatically schedule a drug when the DEA does so, other states require additional state rulemaking or legislative action, which could delay commercialization. Some state and local governments also require manufacturers to operate a drug stewardship program that collects, secures, transports and safely disposes of unwanted drugs.

Entities must register annually with the DEA to manufacture, distribute, dispense, import, export and conduct research using controlled substances. In addition, the DEA requires entities handling controlled substances to maintain records and file reports, including those for thefts or losses of any controlled substances, and to obtain authorization to destroy any controlled substances.

Registered entities are subject to DEA inspection and also must follow specific labeling and packaging requirements, and provide appropriate security measures to control against diversion of controlled substances. Security requirements vary by controlled substance schedule with the most stringent requirements applying to Schedule I and Schedule II controlled substances. Required security measures include background checks on employees and physical control of inventory through measures such as vaults and inventory reconciliations. Failure to follow these requirements can lead to significant civil and/or criminal penalties and possibly even lead to a revocation of a DEA registration. The DEA also has a production and procurement quota system that controls and limits the availability and production of Schedule I or II controlled substances. If we or any of our suppliers of raw materials that are DEA‑classified as Schedule I or II controlled substances are unable to receive any quota or a sufficient quota to meet demand for our products, if any, our business would be negatively impacted.

Public concern over the abuse of medications that are controlled substances, including increased legislative, legal and regulatory action, could negatively affect our business.

Products containing controlled substances may generate public controversy. Certain governmental and regulatory agencies, as well as state and local jurisdictions, are focused on the abuse of controlled substances such as opioids in the United States. State and local governmental agencies have commenced investigations into pharmaceutical companies and others in the supply chain in connection with the distribution of opioid medications. For example, on March 7, 2018 and April 18, 2019, we received citations advising us that the County of Harris Texas and the County of Walker Texas filed lawsuits on December 13, 2017 and January 11, 2019, respectively, against us and various other alleged manufacturers, promoters, sellers and distributors of opioid pharmaceutical products. Through these lawsuits, each of Harris County and Walker County seek to recoup as damages some of the expenses they allegedly have incurred to combat opioid use and addiction. Each of Harris County and Walker County also seeks punitive damages, disgorgement of profits and attorneys’ fees. In addition, multiple lawsuits have been filed against pharmaceutical companies alleging, among other claims, failures to provide effective controls and procedures to guard against the diversion of controlled substances, negligence by distributing controlled substances to pharmacies that serve individuals who abuse controlled substances, and failures to report suspicious orders of controlled substances in accordance with regulations. Certain of these cases have recently been settled, some for hundreds of millions of dollars. In the future, political pressures and adverse publicity could lead to delays in, and increased expenses for, and limit or restrict, the introduction and marketing of our product or product candidates, the withdrawal of currently approved products from the market, or result in other legal action.

In addition, we are aware of other legislative, regulatory or industry measures to address the misuse of prescription opioid medications which could affect our business in ways that we may not be able to predict. For example, the State of New York has undertaken efforts to create an annual surcharge on all manufacturers and distributors licensed to sell or distribute opioids in New York, as well as a tax on sales of opioids in the state. Other states have implemented and are also considering legislation that could require us to pay taxes, licensing fees, or assessments on the distribution of opioid medications in those states. These laws and proposed bills vary in the amounts and the means of calculation. Liabilities for taxes or assessments under any such laws will likely have an adverse impact on our results of operations, unless we are able to mitigate them through operational changes or commercial arrangements where permitted and may result in us ceasing to continue to sell our products in these jurisdictions.

Product liability lawsuits could divert our resources, result in substantial liabilities and reduce the commercial potential of our products.

The risk that we may be sued on product liability claims is inherent in the development of pharmaceutical products. We face a risk of product liability exposure related to the testing of our product candidates in clinical trials and face even greater risks related to the commercialization of our products and upon any commercialization by us of our future products and, if approved, our product candidates, such as claims related to opioid abuse. For example, on March 7, 2018, we received a citation advising us that the County of Harris Texas filed a lawsuit on December 13, 2017 against us and various other alleged manufacturers, promoters, sellers and distributors of opioid pharmaceutical products. On April 18, 2019, we received a citation advising us that the County of Walker Texas filed a lawsuit on January 11, 2019 against us and various other alleged manufacturers, promoters, sellers and distributors of opioid pharmaceutical products. These lawsuits may divert our management from pursuing our business strategy and may be costly to defend. In addition, if we are held liable in any of these lawsuits, we may incur substantial liabilities and may be forced to limit or forego further commercialization of one or more of our products.

Our product liability insurance coverage may not be adequate to cover any and all liabilities that we may incur.

We currently carry product liability insurance coverage, although aggregate limits may not be adequate to cover any and all liabilities that we may incur. Insurance coverage is increasingly expensive and difficult to obtain. We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise. Large judgments have been awarded in class action lawsuits based on drugs that had unanticipated side effects. A successful product liability claim or series of claims brought against us, particularly if judgments exceed our insurance coverage, could decrease our cash and adversely affect our business. In addition, we may not be able to obtain or maintain sufficient insurance coverage at an acceptable cost or otherwise to protect against potential product liability claims, which could prevent or inhibit the commercial production and sale of our products. For example, we have experienced increasing difficulty in procuring insurance coverage for our products, in particular, our opioid‑based product, due to their status as controlled substances.

GENERAL RISK FACTORS

Our business may be adversely affected by the effects of the COVID-19 pandemic.

In December 2019, a novel strain of coronavirus, SARS-CoV-2, causing a disease referred to as COVID-19, was reported to have surfaced in Wuhan, China. It has since spread to multiple other countries and, in March 2020, the World Health Organization declared the COVID-19 outbreak a pandemic. This pandemic has adversely affected or has the potential to adversely affect, among other things, the economic and financial markets and labor resources of the countries in which we operate, our manufacturing and supply chain operations, research and development efforts, commercial operations and sales force, administrative personnel, third-party service providers, business partners and customers, and the demand for some of our marketed products.

The COVID-19 pandemic has resulted in travel and other restrictions to reduce the spread of the disease, including governmental orders across the globe, which, among other things, direct individuals to shelter at their places of residence, direct businesses and governmental agencies to cease non-essential operations at physical locations, prohibit certain non-essential gatherings, maintain social distancing, and order cessation of non-essential travel. As a result of these recent developments, we have implemented work-from-home policies for a significant part of our employees. The effects of shelter-in-place and social distancing orders, government-imposed quarantines, and work-from-home policies may negatively impact productivity, disrupt our business, and delay our business timelines, the magnitude of which will depend, in part, on the length and severity of the restrictions and other limitations on our ability to conduct our business in the ordinary course. Such restrictions and limitations may also negatively impact our access to regulatory authorities (which may be affected, among other things, by travel restrictions and may be delayed in responding to inquiries, reviewing filings, and conducting inspections). The COVID-19 pandemic may also result in the loss of some of our key personnel, either temporarily or permanently. In addition, our sales and marketing efforts may be impacted by postponement of face-to-face meetings and restrictions on access by non-essential personnel to hospitals or clinics, all of which could slow adoption and implementation of our marketed products, resulting in lower net product sales. For example, while the impact of shelter-in-place and social distancing orders, physicians' office closures, and delays in the treatment of patients following the COVID-19 pandemic on our net product sales of our products for the three months ended March 31, 2020 was limited, overall demand was lower in April 2020 compared to the same period of 2019. In addition to other potential impacts of the COVID-19 pandemic on net product sales, we expect to see continued adverse impact on new patient starts for all products while these measures remain in place. Demand for some or all of our marketed products may continue to be reduced while the shelter-in-place or social distancing orders are in effect and, as a result, some of our inventory may become obsolete and may need to be written off, impacting our operating results. These and similar, and perhaps more severe, disruptions in our operations may materially adversely impact our business, operating results, and financial condition.

Quarantines, shelter-in-place, social distancing, and similar government orders (or the perception that such orders, shutdowns, or other restrictions on the conduct of business operations could occur) related to COVID-19 or other infectious diseases are impacting personnel at our research and manufacturing facilities, our suppliers, and other third parties on which we rely, and may impact the availability or cost of materials produced by or purchased from such parties, which could result in a disruption in our supply chain.

In addition, infections and deaths related to COVID-19 may disrupt the United States' healthcare and healthcare regulatory systems. Such disruptions could divert healthcare resources away from, or materially delay, FDA review and potential approval of our marketed products. It is unknown how long these disruptions could continue. Further, while we are focused on therapies to address the COVID-19 pandemic, our other product candidates may need to be de-prioritized. Any elongation or de-prioritization of our other products could materially affect our business.

While the potential economic impact brought by, and the duration of, the COVID-19 pandemic may be difficult to assess or predict, it is currently resulting in significant disruption of global financial markets. This disruption, if sustained or recurrent, could make it more difficult for us to access capital if needed. In addition, a recession or market correction resulting from the spread of COVID-19 could materially affect our business and the value of our common stock. The global COVID-19 pandemic continues to rapidly evolve. The ultimate impact of this pandemic is highly uncertain and subject to change. We do not yet know the full extent of potential delays or impacts on our business, healthcare systems, or the global economy as a whole. These effects could have a material pending legal proceedings, whether routineimpact on our operations. To the extent the COVID-19 pandemic adversely affects our business, prospects, operating results, or non-routine.financial condition.     

Legislative or regulatory reform of the health care system in the United States may adversely impact our business, operations or financial results.

Our industry is highly regulated and changes in law may adversely impact our business, operations or financial results. In particular, in March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively the “Affordable Care Act” or “ACA”), was signed into law. This legislation changes the current system of healthcare insurance and benefits intended to broaden coverage and control costs. The law also contains provisions that will affect companies in the pharmaceutical industry and other healthcare related industries by imposing additional costs and changes to business practices. Provisions affecting pharmaceutical companies include the following:

 

Item 1A.Risk Factors.

mandatory rebates for drugs sold into the Medicaid program have been increased, and the rebate requirement has been extended to drugs used in risk based Medicaid managed care plans.

the 340B Drug Pricing Program under the Public Health Service Act has been extended to require mandatory discounts for drug products sold to certain critical access hospitals, cancer hospitals and other covered entities.

pharmaceutical companies are required to offer discounts on branded drugs to patients who fall within the Medicare Part D coverage gap, commonly referred to as the “Donut Hole."

pharmaceutical companies are required to pay an annual non tax deductible fee to the federal government based on each company’s market share of prior year total sales of branded drugs to certain federal healthcare programs, such as Medicare, Medicaid, Department of Veterans Affairs and Department of Defense.

 

ExceptDespite initiatives to invalidate the ACA, the U.S. Supreme Court has upheld certain key aspects of the legislation, including a tax-based shared responsibility payment imposed on certain individuals who fail to maintain qualifying health coverage for all or part of a year, which is commonly referred to as set forth below, therethe “individual mandate.” However, as a result of tax reform legislation passed in December 2017, the individual mandate has been eliminated effective January 1, 2019. On December 14, 2018, a U.S. District Court judge in the Northern District of Texas ruled that the individual mandate portion of the ACA is an essential and inseverable feature of the ACA, and therefore because the mandate was repealed as part of the Tax Cuts and Jobs Act, the remaining provisions of the ACA are invalid as well. The Trump administration and CMS have both stated that the ruling will have no immediate effect, and on December 30, 2018, the same judge issued an order staying the judgment pending appeal. On December 18, 2019, the Fifth Circuit U.S. Court of Appeals held that the individual mandate is unconstitutional, and remanded the case to the lower court to reconsider its earlier invalidation of the full ACA. Pending review, it is unclear what effect the latest ruling will have on the status of the ACA. Litigation and legislation over the ACA are likely to continue, with unpredictable and uncertain results. We will continue to evaluate the effect that the ACA and its possible repeal and replacement has on our business.

In addition, since January 2017, President Trump has signed two Executive Orders designed to delay the implementation of certain provisions of the ACA or otherwise circumvent some of the requirements for health insurance mandated by the ACA. Further, the Trump administration has concluded that cost‑sharing reduction, or CSR, payments to insurance companies required under the ACA have not received necessary appropriations from Congress and announced that it would discontinue these payments immediately until such appropriations are made. The loss of the CSR payments is expected to increase premiums on certain policies issued by qualified health plans under the ACA. Several state Attorneys General filed suit to stop the administration from terminating the subsidies, but their request for a restraining order was denied by a federal judge in California on October 25, 2017 and again on July 18, 2018. Furthermore, on June 14, 2018, the U.S. Court of Appeals for the Federal Circuit ruled that the federal government was not required to pay more than $12 billion in ACA risk corridor payments to third‑party payors who argued were owed to them. On December 10, 2019, the U.S. Supreme Court heard arguments in Moda Health Plan, Inc. v. United States, which will determine whether the government must make risk corridor payments. On April 27, 2020, the U.S. Supreme Court decided that ACA requires the federal government to compensate insurers for significant losses their health plans incurred during the first three years of the Act’s marketplaces, and that insurers can sue for nonpayment in the Court of Federal Claims. The effects of a potential future gap in reimbursement on third party payors, the viability of the ACA marketplace, providers, and potentially our business, are not yet known. In December 2018, CMS published a final rule permitting further collections and payments to and from certain ACA qualified health plans and health insurance issuers under the ACA risk adjustment program in response to the outcome of the federal district court litigation regarding the method CMS uses to determine this risk adjustment.

Moreover, on January 22, 2018, President Trump signed a continuing resolution on appropriations for fiscal year 2018 that delayed the implementation of certain ACA-mandated fees, including the so called “Cadillac” tax on certain high cost employer-sponsored insurance plans, the annual fee imposed on certain health insurance providers based on market share, and the medical device excise tax on non-exempt medical devices; however, on December 20, 2019, President Trump signed into law the Further Consolidated Appropriations Act (H.R. 1865), which repeals the Cadillac tax, the health insurance provider tax, and the medical device excise tax. It is impossible to determine whether similar taxes could be instated in the future.

In 2021, Congress may consider other legislation to repeal and replace elements of the ACA, and litigation and legislation over the ACA are likely to continue, with unpredictable and uncertain results. Changes to the ACA or other existing health care regulations could significantly impact our business and the pharmaceutical industry. Although it is too early to determine the effect of legal challenges, pending legislation, and executive action on the ACA, the law appears likely to continue the pressure on pharmaceutical pricing, especially under the Medicare program, and may also increase our regulatory burdens and operating costs.

Additionally, other federal health reform measures have been proposed and adopted in the United States since the ACA was enacted:

the Budget Control Act of 2011, among other things, created measures for spending reductions by Congress. A Joint Select Committee on Deficit Reduction, tasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, was unable to reach required goals, thereby triggering the legislation’s automatic reduction to several government programs. These changes included aggregate reductions of Medicare payments to providers of up to 2% per fiscal year, which went into effect in April 2013 and, due to subsequent legislative amendments, will remain in effect through 2027 unless additional Congressional action is taken.

the American Taxpayer Relief Act of 2012, among other things, reduced Medicare payments to several providers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

The Right to Try Act of 2018 provides a federal framework for certain patients to access certain investigational new drug products that have completed a Phase I clinical trial and that are undergoing investigation for FDA approval. Under certain circumstances, eligible patients can seek treatment without enrolling in clinical trials and without obtaining FDA permission under the FDA expanded access program. There is no materialobligation for a drug manufacturer to make its drug products available to eligible patients as a result of the Right to Try Act, but the manufacturer should develop an internal policy and respond to patient requests according to that policy.

Further, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which have resulted in several recent Congressional inquiries and proposed bills designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for products. In addition, the United States government, state legislatures, and foreign governments have shown significant interest in implementing cost containment programs, including price-controls, restrictions on reimbursement and requirements for substitution of generic products for branded prescription drugs to limit the growth of government paid health care costs. Individual states in the United States have become increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

At the federal level, the Trump Administration’s budget proposal for fiscal year 2020 contains further drug price control measures that could be enacted during the 2020 budget process or in other future legislation, including, for example, measures to permit Medicare Part D plans to negotiate the price of certain drugs under Medicare Part B, to allow some states to negotiate drug prices under Medicaid, and to eliminate cost sharing for generic drugs for low-income patients. Additionally, the Trump Administration released a “Blueprint” to lower drug prices and reduce out of pocket costs of drugs that contains additional proposals to increase manufacturer competition, increase the negotiating power of certain federal healthcare programs, incentivize manufacturers to lower the list price of their products and reduce the out of pocket costs of drug products paid by consumers. HHS has already started the process of soliciting feedback on some of these measures and, at the same time, is immediately implementing others under its existing authority. Additionally, in December 2019, the FDA issued a draft guidance document outlining a potential pathway for manufacturers to obtain an additional National Drug Code, or NDC, for an FDA-approved drug that was originally intended to be marketed in a foreign country and that was authorized for sale in that foreign country. The regulatory and market implications of the draft guidance, if finalized, is unknown at this time. Proponents of drug reimportation may attempt to pass legislation that would directly allow reimportation under certain circumstances. Legislation or regulations allowing the reimportation of drugs, if enacted, could decrease the price we receive for any products that we may develop and adversely affect our future revenues and prospects for profitability. Further, Congress and the Trump Administration have each indicated that it will continue to seek new legislative and/or administrative measures to control drug costs. For example, on September 25, 2019, the Senate Finance Committee introduced the Prescription Drug Pricing Reduction Act of 2019, a bill intended to reduce Medicare and Medicaid prescription drug prices. The proposed legislation would restructure the Part D benefit, modify payment methodologies for certain drugs, and impose an inflation cap on drug price increases. An even more restrictive bill, the Lower Drug Costs Now Act of 2019, was introduced in the House of Representatives on September 19, 2019, and would require the Department of Health and Human Services (HHS) to directly negotiate drug prices with manufacturers. The Lower Drugs Costs Now Act of 2019 has passed out of the House and was delivered to the Senate on December 16, 2019. However, it is unclear whether either of these bills will make it through both chambers and be signed into law, and if either is enacted, what effect it would have on our business. At the state level, legislatures have become increasingly active in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, have been designed to encourage importation from other countries and bulk purchasing. We anticipate pricing scrutiny will continue and escalate, including on a global basis. As a result, our business and reputation may be harmed, our stock price may be adversely impacted and experience periods of volatility, and our results of operations may be adversely impacted.

CMS may also develop new payment and delivery models, such as bundled payment models. CMS finalized regulations that give states greater flexibility in setting benchmarks for insurers in the individual and small group marketplaces, which may have the effect of relaxing the essential health benefits required under the ACA for plans sold through such marketplaces. Additionally, CMS finalized a rule that amends the Medicare Advantage and Medicare Part D prescription drug benefit regulations to reduce out of pocket costs for plan enrollees and allow Medicare plans to negotiate lower rates for certain drugs. In May 2019, CMS issued a final rule to allow Medicare Advantage Plans the option of using step therapy, a type of prior authorization, for Part B drugs beginning January 1, 2020. This final rule codified CMS’s policy change that was effective January 1, 2019. CMS is still considering proposed changes to the discussiondefinition of risk“negotiated prices” in the regulations. It is unclear what effect such changes will have on our business and ability to receive adequate reimbursement for our products.

In addition, in September 2007, the Food and Drug Administration Amendments Act of 2007 was enacted giving the FDA enhanced post-marketing authority including the authority to require post-marketing studies and clinical trials, labeling changes based on new safety information and compliance with REMS approved by the FDA. The FDA’s exercise of this authority could result in delays or increased costs during product development, clinical trials and regulatory review, increased costs to ensure compliance with post-approval regulatory requirements and potential restrictions on the sale and/or distribution of approved products.

Moreover, we cannot predict what healthcare reform initiatives may be adopted in the future. Further federal and state legislative and regulatory developments are likely, and we expect ongoing initiatives in the United States to increase pressure on drug pricing. Such reforms could have an adverse effect on anticipated revenues from product candidates that we may successfully develop and for which we may obtain regulatory approval and may affect our overall financial condition and ability to develop product candidates.

Inadequate funding for the FDA, and other government agencies could prevent our new products, services and product candidates from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.

The ability of the FDA to review and approve new products can be affected by a variety of factors, includedincluding government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of government agencies on which our most recent Annual Reportoperations may rely, including those that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.

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Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which could adversely affect our business. Any government shutdown or other disruption of normal activities at these regulatory agencies, such as the FDA, could lead to a delay or stop in critical activities. If a prolonged government shutdown were to occur, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on Form 10-K, as amended.our business.

Our Enzastaurinproductcandidate is being developed for other indications by other sponsors.Any undesirableadverseevents that occur in relation to the activities by other sponsors could delay or prevent our regulatory approval, limit the commercial profile of Enzastaurin, or result in significant negative consequences following any regulatory approval.

Undesirable adverse events that occur in relation to the activities by other sponsors related to our Enzastaurin product candidate could cause us or regulatory authorities to interrupt, delay or halt development or could result in the delay or denial of regulatory approval by the FDA or other comparable regulatory authorities.  Drug-related adverse events involving Enzastaurin by other sponsors could also harm our reputation, business, financial condition and business prospects.

Additionally, if Enzastaurin receives regulatory approval, and we or others later identify undesirable side effects caused by such drugs, a number of potentially significant negative consequences could result, including but not limited to:

 

Item 2.Unregistered Sales

suspending the marketing of Securities and Use of Proceeds.the drug;

None.

Item 3.Defaults Upon Senior Securities.

None.

Item  4.Mine Safety Disclosures.

None.

Item 5.Other Information.

None.

Item  6.Exhibits.

Exhibit

Number

 Description

having regulatory authorities withdraw approvals of the drug;

adding warnings on the label;

conducting post-market studies;
   
31.1

being sued and held liable for harm caused to subjects or patients; and

damage to our reputation.
 Certificate

Any of these events could prevent us from achieving or maintaining market acceptance of Enzastaurin, if approved, and could significantly harm our business, results of operations and prospects.

We may seek Orphan Drug Designation or other designations for our product candidates, but even if designated we may not ultimately realize the potential benefits of such designations.

We may seek Orphan Drug Designation or other designations for our product candidates from the FDA. Under the Orphan Drug Act, the FDA may designate a drug product as an orphan drug if it is intended to treat a rare disease or condition, defined as a patient population of fewer than 200,000 in the United States, or a patient population greater than 200,000 in the United States but where there is no reasonable expectation to recover the costs of developing and marketing a treatment drug in the United States. In the United States, orphan drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages, and application fee waivers. After the FDA grants Orphan Drug Designation, the generic identity of the drug and its potential orphan use are disclosed publicly by the FDA. However, Orphan Drug Designation nor any other designation shortens the development time nor regulatory review time of a product candidate nor gives the candidate any advantage in the regulatory review or approval process.

In addition, if a product receives the first FDA approval for the indication for which it has orphan designation, the product is entitled to orphan drug exclusivity, which means the FDA may not approve any other application to market the same drug for the same indication for a period of seven years, except in limited circumstances, such as a demonstration of clinical superiority over the product with orphan exclusivity or where the manufacturer is unable to assure sufficient product quantity for the orphan patient population. Exclusive marketing rights in the United States may also be unavailable if we or our collaborators seek approval for an indication broader than the orphan designated indication and may be lost if the FDA later determines that the request for designation was materially defective. Even if we obtain Orphan Drug Designation, we may not be the first to obtain marketing approval for any particular orphan indication due to the uncertainties associated with developing pharmaceutical products. Further, even if we obtain orphan drug exclusivity for a product candidate, that exclusivity may not effectively protect the product from competition because different drugs can be approved for the same condition. Even after an orphan drug is approved, the FDA can subsequently approve the same drug for the same condition if the FDA concludes that the later drug is clinically superior in that it is safer, more effective, or makes a major contribution to patient care.

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We may never realize the expected benefits from the divestiture of Natesto.

The divestiture of Natesto is part of a strategy to transform ourselves into a high growth, specialty pharmaceutical company. If we are unable to achieve our growth and profitability objectives due to competition, lack of acceptance of our products, failure to generate favorable clinical data or gain regulatory approvals, or other risks as described in this section, or due to other events, we will not be successful in transforming our business and may not see the appropriate market valuation. Moreover, Natesto generated substantial revenue historically which we may not be able to replace. While over time we expect to replace this revenue by investing in, acquiring and accelerating other revenue streams, there is a risk we will be unable to replace the revenue that Natesto generated, or that the cost of such will be higher than expected. In addition, we may not ultimately receive the full benefits from the divestiture over the term as expected. If we are unable to achieve our growth objectives, such failure will be exacerbated by the loss of revenue generated by Natesto, and could materially impact our financial position and results of operations, resulting in a decline in our stock price.

Clinical drug development is a lengthy and expensive process with uncertain timelines and uncertain outcomes. If clinical trials of any future therapeutic candidates are prolonged or delayed, we or our current or future collaborators may be unable to obtain required regulatory approvals, and therefore we will be unable to commercialize our future therapeutic candidates on a timely basis or at all, which will adversely affect our business.

Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial process and our future clinical trial results may not be successful. We may experience delays in initiating or completing our clinical trials. We may also experience numerous unforeseen events during our clinical trials that could delay or prevent our ability to receive marketing approval or commercialize any future therapeutic candidates.

Our clinical trials may fail to demonstrate substantial evidence of the safety and effectiveness of future product candidates that we may identify and pursue, which would prevent, delay or limit the scope of regulatory approval and commercialization.

Before obtaining regulatory approvals for the commercial sale of future therapeutic candidates, we must demonstrate through lengthy, complex and expensive nonclinical studies, preclinical studies and clinical trials that the applicable therapeutic candidate is both safe and effective for use in each target indication. A therapeutic candidate must demonstrate an adequate risk versus benefit profile in its intended patient population and for its intended use.

Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Most product candidates that begin clinical trials are never approved by regulatory authorities for commercialization. We have limited experience in designing clinical trials and may be unable to design and execute a clinical trial to support marketing approval.

We cannot be certain that any clinical trials will be successful. In some instances, there can be significant variability in safety or efficacy results between different clinical trials of the same therapeutic candidate due to numerous factors, including changes in trial procedures set forth in protocols, differences in the size and type of the patient populations, changes in and adherence to the clinical trial protocols and the rate of dropout among clinical trial participants.

Even if any of our future therapeutic candidates obtain regulatory approval, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense. Additionally, any such therapeutic candidates, if approved, could be subject to labeling and other restrictions and market withdrawal, and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with any of our future therapeutic candidates.

If the FDA or a comparable foreign regulatory authority approves any of our future therapeutic candidates, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion and recordkeeping for the therapy and underlying therapeutic substance will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with current good manufacturing practice (“cGMP”) and with good clinical practice (“GCP”) for any clinical trials that we conduct post-approval, all of which may result in significant expense and limit our ability to commercialize such therapies. Later discovery of previously unknown problems with any approved therapeutic candidate, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things:

restrictions on the labeling, distribution, marketing or manufacturing of Chief Executive Officer pursuant to Section 302our future therapeutic candidates, withdrawal of the Sarbanes-Oxley Actproduct from the market, or product recalls;

untitled and warning letters, or holds on clinical trials;

refusal by the FDA or other foreign regulatory body to approve pending applications or supplements to approved applications we filed or suspension or revocation of 2002.license approvals;

requirements to conduct post-marketing studies or clinical trials;

48

restrictions on coverage by third-party payors;

fines, restitution or disgorgement of profits or revenue;
   
31.2Certificatesuspension or withdrawal of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.marketing approvals:
   
32.1Certificate of Chief Executive Officer and Chief Financial Officer pursuantproduct seizure or detention, or refusal to Section 906permit the import or export of the Sarbanes-Oxley Act of 2002*.product; and
   
101injunctions or the imposition of civil or criminal penalties.
 XBRL (eXtensible Business Reporting Language). The following materials from Aytu BioScience, Inc.’s Quarterly Report on Form 10-Q

In addition, any regulatory approvals that we receive for our future therapeutic candidates may also be subject to limitations on the approved indicated uses for which the therapy may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase IV clinical trials, and surveillance to monitor the safety and efficacy of such therapeutic candidates.

If there are changes in the application of legislation, regulations or regulatory policies or if we or one of our distributors, licensees or co-marketers fails to comply with regulatory requirements, the regulators could take various actions. These include imposing fines on us, imposing restrictions on the therapeutic or its manufacture and requiring us to recall or remove the therapeutic from the market. The regulators could also suspend or withdraw our marketing authorizations, requiring us to conduct additional clinical trials, change our therapeutic labeling or submit additional applications for marketing authorization. If any of these events occurs, our ability to sell such therapy may be impaired, and we may incur substantial additional expense to comply with regulatory requirements, which could materially adversely affect our business, financial condition and results of operations.

The results of preclinical studies and early-stage clinical trials of our future therapeutic candidates may not be predictive of the results of later stage clinical trials. Initial success in our ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials.

Therapeutic candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and initial clinical trials. Furthermore, there can be no assurance that any of our clinical trials will ultimately be successful or support further clinical development of any of our future therapeutic candidates. There is a high failure rate for drugs proceeding through clinical trials. A number of companies in the pharmaceutical industry have suffered significant setbacks in clinical development even after achieving promising results in earlier studies.

We will depend on enrollment of patients in our clinical trials for our future therapeutic candidates. If we are unable to enroll patients in our clinical trials, our research and development efforts and business, financial condition and results of operations could be materially adversely affected.

Identifying and qualifying patients to participate in our clinical trials will be critical to our success. Patient enrollment depends on many factors, including:

the size of the patient population required for analysis of the trial’s primary endpoints and the process for identifying patients;

identifying and enrolling eligible patients, including those willing to discontinue use of their existing medications;

the design of the clinical protocol and the patient eligibility and exclusion criteria for the quarter ended December 31, 2017 formattedtrial;

safety profile, to date, of the therapeutic candidate under study;

the willingness or availability of patients to participate in XBRL: (i) the Consolidated Balance Sheet, (ii) the Consolidated Statement of Operations, (iii) the Consolidated Statement of Stockholders’ Equity (Deficit), (iv) the Consolidated Statement of Cash Flows, and (v) the Consolidated Notesour trials, including due to the Financial Statements.perceived risks and benefits, stigma or other side effects of use of a controlled substance;

perceived risks and benefits of our approach to treatment of indication;
the proximity of patients to clinical sites:
our ability to recruit clinical trial investigators with the appropriate competencies and experience;
the availability of competing clinical trials;

49

the availability of new drugs approved for the indication the clinical trial is investigating;
clinicians’ and patients’ perceptions of the potential advantages of the drug being studied in relation to other available therapies, including any new therapies that may be approved for the indications we are investigating; and
our ability to obtain and maintain patient informed consents.

Even once enrolled, we may be unable to retain a sufficient number of patients to complete any of our trials.

In addition, any negative results we may report in clinical trials may make it difficult or impossible to recruit and retain patients in other clinical trials of that same therapeutic candidate. Delays in the enrollment for any clinical trial will likely increase our costs, slow down the approval process and delay or potentially jeopardize our ability to commence sales of our future therapeutic candidates and generate revenue. In addition, some of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of any future therapeutic candidates.

The future commercial success of our future therapeutic candidates will depend on the degree of market access and acceptance of our potential therapies among healthcare professionals, patients, healthcare payors, health technology assessment bodies and the medical community at large.

We may never have a therapy that is commercially successful. To date, we have no therapy authorized for marketing. Furthermore, if approved, our future therapies may not achieve an adequate level of acceptance by payors, health technology assessment bodies, healthcare professionals, patients and the medical community at large, and we may not become profitable. The level of acceptance we ultimately achieve may be affected by negative public perceptions and historic media coverage of psychedelic substances, including psilocybin. Because of this history, efforts to educate the medical community and third-party payors and health technologies assessment bodies on the benefits of our future therapies may require significant resources and may never be successful, which would prevent us from generating significant revenue or becoming profitable. Market acceptance of our future therapies by healthcare professionals, patients, healthcare payors and health technology assessment bodies will depend on a number of factors, many of which are beyond our control, including, but not limited to, the following:

��

acceptance by healthcare professionals, patients and healthcare payors of each therapy as safe, effective and cost-effective;

changes in the standard of care for the targeted indications for any therapeutic candidate;

the strength of sales, marketing and distribution support;

potential product liability claims;

the therapeutic candidate’s relative convenience, ease of use, ease of administration and other perceived advantages over alternative therapies;

the prevalence and severity of adverse events or publicity;
limitations, precautions or warnings listed in the summary of therapeutic characteristics, patient information leaflet, package labeling or instructions for use:
the cost of treatment with our therapy in relation to alternative treatments;
the ability to manufacture our product in sufficient quantities and yields;
the availability and amount of coverage and reimbursement from healthcare payors, and the willingness of patients to pay out of pocket in the absence of healthcare payor coverage or adequate reimbursement;
the willingness of the target patient population to try, and of healthcare professionals to prescribe, the therapy;
any potential unfavorable publicity, including negative publicity associated with recreational use or abuse of psilocybin;
the extent to which therapies are approved for inclusion and reimbursed on formularies of hospitals and managed care organizations; and
whether our therapies are designated under physician treatment guidelines or under reimbursement guidelines as a first-line, second-line, third-line or last-line therapy.

If our future therapeutic candidates fail to gain market access and acceptance, this will have a material adverse impact on our ability to generate revenue to provide a satisfactory, or any, return on our investments. Even if some therapies achieve market access and acceptance, the market may prove not to be large enough to allow us to generate significant revenue.

50

Changes in methods of therapeutic candidate or commercial product manufacturing or formulation may result in additional costs or delay.

As therapeutic candidates are developed through preclinical studies to late-stage clinical trials towards potential approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods and formulation, may be altered along the way in an effort to optimize processes and results. Any of these changes could cause any of our current products or future therapeutic candidates to perform differently and affect the results of planned clinical trials or other future clinical trials conducted with the materials manufactured using altered processes. Such changes may also require additional testing, FDA notification or FDA approval. This could delay completion of clinical trials, require the conduct of bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of any of our future therapeutic candidates and jeopardize our ability to commence product sales and generate revenue.

We may become exposed to costly and damaging liability claims, either when testing our future therapeutic candidates in the clinic or at the commercial stage, and our product liability insurance may not cover all damages from such claims.

We will be exposed to potential product liability and professional indemnity risks that are inherent in the research, development, manufacturing, marketing and use of therapeutic candidates. Any failure of future therapeutic candidates by us and our corporate collaborators in clinical trials may expose us to liability claims as may the potential sale of any therapies approved in the future. These claims might be made by patients who use our therapies, healthcare providers, pharmaceutical companies, our corporate collaborators or other third parties that research or sell our therapies. Any claims against us, regardless of their merit, could be difficult and costly to defend and could materially adversely affect the market for our future therapeutic candidates or any prospects for commercialization of our future therapeutic candidates. Although the clinical trial process is designed to identify and assess potential side effects, it is always possible that a drug, even after regulatory approval, may exhibit unforeseen side effects. If any of our future therapeutic candidates causes adverse side effects during clinical trials or after regulatory approval, we may be exposed to substantial liabilities.

Physicians and patients may not comply with warnings that identify known potential adverse effects and describe which patients should not use any of our future therapeutic candidates. Regardless of the merits or eventual outcome, liability claims may cause, among other things, the following;

decreased demand for our therapies due to negative public perception;

injury to our reputation;

withdrawal of clinical trial participants or difficulties in recruiting new trial participants;

initiation of investigations by regulators;

costs to defend or settle the related litigation;

a diversion of management’s time and our resources;
substantial monetary awards to trial participants or patients:
recalls, withdrawals or labeling, marketing or promotional restrictions;
loss of revenue from therapeutic sales; and
our inability to commercialize any of our future therapeutic candidates, if approved.

51

In addition we may not be able to obtain or maintain insurance coverage at a reasonable cost or obtain insurance coverage that will be adequate to satisfy all liabilities that may arise. If a successful product liability claim or series of claims is brought against us for uninsured liabilities or in excess of insured liabilities, our assets may not be sufficient to cover such claims and our business, financial condition and results of operations could be materially adversely affected. Liability claims resulting from any of the events described above could have a material adverse effect on our business, financial condition and results of operations.

Failure to comply with health and data protection laws and regulations could lead to U.S. federal and state government enforcement actions, including civil or criminal penalties, private litigation, and adverse publicity and could negatively affect our operating results and business.

We and any potential collaborators may be subject to U.S. federal and state data protection laws and regulations, such as laws and regulations that address privacy and data security. In the United States, numerous federal and state laws and regulations, including state data breach notification laws, state health information privacy laws, and federal and state consumer protection laws, govern the collection, use, disclosure, and protection of health-related and other personal information. In addition, we may obtain health information from third parties, including research institutions from which we obtain clinical trial data, which are subject to privacy and security requirements under HIPAA, as amended by HITECH. To the extent that we act as a business associate to a healthcare provider engaging in electronic transactions, we may also be subject to the privacy and security provisions of HIPAA, as amended by HITECH, which restricts the use and disclosure of patient-identifiable health information, mandates the adoption of standards relating to the privacy and security of patient-identifiable health information, and requires the reporting of certain security breaches to healthcare provider customers with respect to such information. Additionally, many states have enacted similar laws that may impose more stringent requirements on entities like ours. Depending on the facts and circumstances, we could be subject to significant civil, criminal, and administrative penalties if we obtain, use, or disclose individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA.

Compliance with U.S. and foreign privacy and data protection laws and regulations could require us to take on more onerous obligations in our contracts, restrict our ability to collect, use and disclose data, or in some cases, impact our ability to operate in certain jurisdictions. Failure to comply with these laws and regulations could result in government enforcement actions (which could include civil, criminal and administrative penalties), private litigation, and/or adverse publicity and could negatively affect our operating results and business. Moreover, clinical trial subjects, employees and other individuals about whom we or our potential collaborators obtain personal information, as well as the providers who share this information with us, may limit our ability to collect, use and disclose the information. Claims that we have violated individuals’ privacy rights, failed to comply with data protection laws, or breached our contractual obligations, even if we are not found liable, could be expensive and time-consuming to defend and could result in adverse publicity that could harm our business.

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

None.

Item 3. Defaults Upon Senior Securities.

None.

Item 4. Mine Safety Disclosures.

Not Applicable.

Item 5. Other Information.

None.

Item 6. Exhibits.

Exhibit No.

 

Description

 

Registrants Form

 

Date Filed

 

Exhibit Number

 

Filed Herewith

            
2.1 

Agreement and Plan of Merger, dated as of September 12, 2019, by and among Aytu BioScience, Inc., Aytu Acquisition Sub, Inc. and Innovus Pharmaceuticals, Inc.

 

8-K

 

9/18/19

  2.1  
            
2.2 

Asset Purchase Agreement, dated October 10, 2019

 

8-K

 

10/15/19

  2.1  
            
2.3 Agreement and Plan of Merger, dated as of December 10, 2020, by and among Aytu BioScience, Inc., Neutron Acquisition Sub, Inc. and Neos Therapeutics, Inc. 8-K 12/10/2020  2.1  
            
2.4 Asset Purchase Agreement, dated April 12, 2021        X
            
3.1 

Certificate of Incorporation effective June 3, 2015

 

8-K

 

6/09/15

  3.1  
            
3.2 

Certificate of Amendment of Certificate of Incorporation effective June 1, 2016

 

8-K

 

6/02/16

  3.1  
            
3.3 

Certificate of Amendment of Certificate of Incorporation, effective June 30, 2016

 

8-K

 

7/01/16

  3.1  
            
3.4 

Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock, filed on August 11, 2017

 

8-K

 

8/16/17

  3.1  
            
3.5 

Certificate of Amendment of Certificate of Incorporation, effective August 25, 2017

 

8-K

 

8/29/17

  3.1  
            
3.6 

Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock filed on March 2, 2018

 

S-1/A

 

2/27/18

  3.6  
            
3.7 

Certificate of Amendment to the Restated of Certificate of Incorporation, effective August 10, 2018

 

8-K

 

8/10/18

  3.1  
            
3.8 

Amended and Restated Bylaws

 

8-K

 

6/09/15

  3.2  
            
3.9 

Certificate of Designation of Preferences, Rights and Limitations of Series E Convertible Preferred Stock

 

10-Q

 

2/7/19

  10.4  
            
3.10 

Certificate of Designation of Preferences, Rights and Limitations of Series F Convertible Preferred Stock

 

8-K

 

10/15/19

  3.1  
            
3.11 

Certificate of Designation of Preferences, Rights and Limitations of Series G Convertible Preferred Stock

 

8-K

 

11/4/19

  3.1  
            
3.12 Certificate of Amendment to the Restated Certificate of Incorporation, effective December 7, 2020 8-K 12/8/2020  3.1  
            
3.13 Certificate of Amendment of Certificate of Incorporation of Aytu Bioscience, Inc., effective March 19, 2021. 8-K 3/22/2021  3.1  

53

4.1 

Form of Placement Agent Warrant issued in 2015 Convertible Note Financing

 

8-K

 

7/24/15

  4.2  
            
4.2 

Warrant Agent Agreement, dated May 6, 2016 by and between Aytu BioScience, Inc. and VStock Transfer, LLC

 

8-K

 

5/6/16

  4.1  
            
4.3 

First Amendment to May 6, 2016 Warrant Agent Agreement between Aytu BioScience, Inc. and VStock Transfer LLC

 

S-1

 

9/21/16

  4.5  
            
4.4 

Warrant Agent Agreement, dated November 2, 2016 by and between Aytu BioScience, Inc. and VStock Transfer, LLC

 

8-K

 

11/2/16

  4.1  
            
4.5 

Form of Amended and Restated Underwriters Warrant (May 2016 Financing)

 

8-K

 

3/1/17

  4.1  
            
4.6 

Form of Amended and Restated Underwriters Warrant (October 2016 Financing)

 

8-K

 

3/1/17

  4.2  
            
4.7 

Form of Common Stock Purchase Warrant issued on August 15, 2017

 

8-K

 

8/16/17

  4.1  
            
4.8 

Form of Common Stock Purchase Warrant for March 2018 Offering

 

S-1

 

2/27/18

  4.8  
            
4.9 

Form of Pre-Funded Purchase Warrant

 

8-K

 

3/13/20

  4.1  
            
4.10 

Form of Placement Agents Warrant

 

8-K

 

3/13/20

  4.2  
            
4.11 

Form of Warrant

 

8-K

 

3/13/20

  4.1  
            
4.12 

Form of Placement Agents Warrant

 

8-K

 

3/13/20

  4.2  
            
4.13 

Form of Warrant

 

8-K

 

3/20/20

  4.1  
            
4.14 

Form of Placement Agents Warrants

 

8-K

 

3/20/20

  4.2  
            
4.15 

Form of Wainwright Warrant

 

8-K

 

7/2/20

  4.1  
            
4.16 Form of Underwriter's Warrant 8-K 12/14/2020  4.1  
            
10.1 

Amended Employment Agreement with Joshua R. Disbrow dated July 1, 2020

 

10-K

 

10/6/20

  10.62  
            
10.2 

Amended Employment Agreement with David A. Green dated July 1, 2020

 

10-K

 

10/6/20

  10.63  

\

10.3 License Agreement with Avrio Genetics, LLC, dated January 20, 2020* 10-Q 2/11/2021  10.1  
            
10.4 Consent, Waiver and Sixth Amendment to Facility Agreement, by and among Aytu BioScience, Inc., Neos Therapeutics, Inc., Neos Therapeutics Brands, LLC, Neos Therapeutics, LP, Neos Therapeutics Commercial, LLC, PharmaFab Texas, LLC, Deerfield Private Design Fund III L.P., Deerfield Partners, L.P. and Deerfield Mgmt, L.P., dated March 19, 2021. 8-K 3/22/2021  10.1  

54

10.5 Consent, Waiver and Amendment No. 1 to Loan and Security Agreement, by and among Aytu BioScience, Inc., Neos Therapeutics, Inc., Neos Therapeutics Brands, LLC, Neos Therapeutics, LP, Neos Therapeutics Commercial, LLC, PharmaFab Texas, and Encina Business Credit, LLC, dated March 19, 2021. 8-K 3/22/2021  10.2  
            
10.6 Employment Agreement between Aytu BioPharma, Inc. and Richard Eisenstadt, dated March 31, 2021. 8-K 4/5/2021  10.1  
            
10.7 Indemnification Agreement between Aytu BioPharma, Inc. and Gerald McLaughlin, dated March 19, 2021.        X
            
10.8 Indemnification Agreement between Aytu BioPharma, Inc. and Beth P. Hecht, dated March 19, 2021.        X
            
10.9 Termination and Transition Agreement between Aytu BioPharma, Inc. and Acerus Pharmaceuticals Corporation, dated March 31, 2021.        X
            
10.10 Separation Agreement between Aytu BioPharma, Inc. and David A. Green, dated March 31, 2021.        X
            
10.11 Second Amendment to Employment Agreement with Joshua R. Disbrow dated April 7, 2021.        X
            
10.12 Employment Agreement between Aytu BioPharma, Inc. and Nathaniel Massari, dated April 12, 2021.        X
            
10.13 Employment Agreement between Aytu BioPharma, Inc. and Christopher Brooke, dated April 12, 2021.        X
            
10.14 Option and Exclusive License Agreement between Rumpus VEDS, LLC and Denovo Biopharma LLC, dated December 21, 2019        X
            
10.15 Exclusive License Agreement between Rumpus VEDS, LLC and Johns Hopkins University, dated December 20, 2019.        X
            
31.1 

Certificate of the Chief Executive Officer of Aytu BioPharma, Inc. pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

        

X

            
31.2 

Certificate of the Chief Executive Officer and the Chief Financial Officer of Aytu BioPharma, Inc. pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

        

X

            
32.1 Certificate of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*.        X
            
101 XBRL (extensible Business Reporting Language). The following materials from Aytu BioScience, Inc.’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2021 formatted in XBRL: (i) the Consolidated Balance Sheet, (ii) the Consolidated Statement of Operations, (iii) the Consolidated Statement of Stockholders’ Equity (Deficit), (iv) the Consolidated Statement of Cash Flows, and (v) the Consolidated Notes to the Financial Statements.        

 

X

Indicates is a management contract or compensatory plan or arrangement.

 

*

The certification attached as Exhibit 32.1 accompanying

Information in this Quarterly Report on Form 10-Qexhibit identified by brackets is confidential and has been excluded pursuant to 18 U.S.C. Section 1350, as adopted pursuantItem 601(b)(10)(iv) of Regulation S-K because it is not material and would likely cause competitive harm to Section 906the Company if publicly disclosed. An unredacted copy of the Sarbanes-Oxley Act of 2002, shall notthis exhibit will be deemed “filed” by the Registrant for purposes of Section 18 offurnished to the Securities and Exchange Act of 1934, as amended.Commission on a supplemental basis upon request.

 

 

SIGNATURES

 

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

 

 

AYTU BIOSCIENCE,BIOPHARMA, INC.

   
 By:

Date:

May 17, 2021

By:

/s/ Joshua R. Disbrow

 Joshua R. Disbrow
Chief Executive Officer
Date: February 8, 2018
   
 By:

Joshua R. Disbrow

/s/ David A. Green
  David A. Green
  

Chief FinancialExecutive Officer

 Date: February 8, 2018

 

24
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