Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

FORM 10-Q

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

 

For the quarterly period ended JanuaryOctober 31, 20182021

 

ORor

 

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

For the transition period from ____________________ to ____________________

 

Commission file number: 001-32839

 

AVID BIOSERVICES, INC.

(Exact name of Registrant as specified in its charter)

Delaware

95-3698422

(State or other jurisdiction of

incorporation or organization)

95-3698422

(I.R.S. Employer

Identification No.)

2642 Michelle Drive,Suite 200, Tustin, California

92780

(Address of principal executive offices)offices and zip code)

(Zip Code)

 

(714)508-6100

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, $0.001 par value per shareCDMOThe NASDAQ Stock Market LLC

 

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.

Yesý ☒    No o

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).

Yesý Noo

 

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

 

Large accelerated filer oAccelerated filer x
Non-accelerated filero
(Do not check if a smaller reporting company)
Smaller reporting company o
 Emerging growth company o

 

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.o

 

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

Yeso ☐   Noý

 

As of March 7, 2018, there were 55,552,233December 1, 2021, the number of shares of registrant’s common stock $0.001 par value, outstanding.

outstanding was 61,581,464.

 

   

 

 

AVID BIOSERVICES, INC.

 

Form 10-Q

For The Quarter Ended October 31, 2021

TABLE OF CONTENTS

 

 Page
No.
PART I - FINANCIAL INFORMATION1
Item 1.Condensed Consolidated Financial Statements.Statements (Unaudited)1
Item 2.Management’s Discussion and Analysis of Financial Condition And Results of Operations.Operations1822
Item 3.Quantitative and Qualitative Disclosures About Market Risk.Risk2429
Item 4.Controls And Procedures29
Item 4.   Controls And Procedures.24
PART II - OTHER INFORMATION24
Item 1.Legal Proceedings.Proceedings24
Item 1A.   Risk Factors.24
Item 2.   Unregistered Sales of Equity Securities and Use of Proceeds.30
Item 3.   Defaults Upon Senior Securities.1A.Risk Factors30
Item 4.   Mine Safety Disclosures.6.Exhibits30
Item 5.   Other Information.30
Item 6.   Exhibits.31
SIGNATURES32

The terms “we,” “us,” “our,” “the Company,” and “Avid,” asAs used in this Quarterly Report on Form 10-Q, except where the context otherwise requires or where otherwise indicated, the terms “we,” “us,” “our,” and the “Company” refer to Avid Bioservices, Inc. and its consolidated subsidiaries.subsidiary.

 i 

 

PART I - I—FINANCIAL INFORMATION

 

Item 1.Condensed Consolidated Financial Statements.Statements (Unaudited)

 

avid bioservices, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited) (In thousands, except par value)

  

January 31,

2018

  

April 30,

2017

 
   Unaudited   (Note 2) 
ASSETS        
Current assets:        
Cash and cash equivalents $17,938,000  $46,799,000 
Trade and other receivables  7,967,000   7,742,000 
Inventories  14,218,000   33,099,000 
Prepaid expenses  906,000   1,460,000 
Total current assets  41,029,000   89,100,000 
Property and equipment, net  26,325,000   26,515,000 
Restricted cash  1,150,000   1,150,000 
Other assets  1,353,000   1,347,000 
Total assets $69,857,000  $118,112,000 
LIABILITIES AND STOCKHOLDERS’ EQUITY        
Current liabilities:        
Accounts payable $1,911,000  $5,779,000 
Accrued clinical trial and related fees  5,503,000   4,558,000 
Accrued payroll and related costs  3,876,000   6,084,000 
Deferred revenue  6,633,000   28,500,000 
Customer deposits  17,602,000   17,017,000 
Other current liabilities  749,000   993,000 
Total current liabilities  36,274,000   62,931,000 
         
Deferred rent, less current portion  2,064,000   1,599,000 
         
Commitments and contingencies        
         
Stockholders’ equity:        
Preferred stock—$0.001 par value; authorized 5,000,000 shares; 1,647,760 issued and outstanding at January 31, 2018 and April 30, 2017, respectively  2,000   2,000 
Common stock—$0.001 par value; authorized 500,000,000 shares; 45,257,180 and 44,014,040 issued and outstanding at January 31, 2018 and April 30, 2017, respectively  45,000   44,000 
Additional paid-in capital  593,621,000   590,971,000 
Accumulated deficit  (562,149,000)  (537,435,000)
Total stockholders’ equity  31,519,000   53,582,000 
Total liabilities and stockholders’ equity $69,857,000  $118,112,000 

         
  

October 31,

2021

  

April 30,

2021

 
ASSETS        
Current assets:        
Cash and cash equivalents $163,675  $169,915 
Accounts receivable, net  18,137   18,842 
Contract assets  3,420   6,112 
Inventory  20,310   11,871 
Prepaid expenses  1,377   1,064 
Total current assets  206,919   207,804 
Property and equipment, net  52,496   37,455 
Operating lease right-of-use assets  38,223   18,691 
Other assets  3,639   1,210 
Restricted cash  350   350 
Total assets $301,627  $265,510 
         
LIABILITIES AND STOCKHOLDERS’ EQUITY        
Current liabilities:        
Accounts payable $10,005  $9,257 
Accrued payroll and related costs  5,053   8,794 
Contract liabilities  51,865   50,769 
Current portion of operating lease liabilities  1,378   1,355 
Other current liabilities  1,227   761 
Total current liabilities  69,528   70,936 
         
Convertible senior notes, net  139,066   96,949 
Operating lease liabilities, less current portion  39,664   19,889 
Finance lease liabilities, less current portion  2,264   0 
Total liabilities  250,522   187,774 
         
Commitments and contingencies      
         
Stockholders’ equity:        
Preferred stock, $0.001 par value; 5,000 shares authorized; 0 shares issued and outstanding at October 31, 2021 and April 30, 2021, respectively  0   0 
Common stock, $0.001 par value; 150,000 shares authorized; 61,552 and 61,069 shares issued and outstanding at October 31, 2021 and April 30, 2021, respectively  62   61 
Additional paid-in capital  600,266   637,534 
Accumulated deficit  (549,223)  (559,859)
Total stockholders’ equity  51,105   77,736 
Total liabilities and stockholders’ equity $301,627  $265,510 

 

See accompanying notes to condensed consolidated financial statements.

 

 

 

 1 

 

 

avid bioservices, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS and comprehensive loss (UNAUDITED)INCOME

(Unaudited) (In thousands, except per share information)

  

Three Months Ended

January 31,

  

Nine Months Ended

January 31,

 
  2018  2017  2018   2017 
              
Contract manufacturing revenue $6,819,000  $10,747,000  $46,678,000  $39,726,000 
Cost of contract manufacturing  10,951,000   7,974,000   47,641,000   26,477,000 
Gross profit (loss)  (4,132,000)  2,773,000   (963,000)  13,249,000 
                 
Operating expenses:                
Selling, general and administrative  4,824,000   4,365,000   12,273,000   13,602,000 
Restructuring charges        1,258,000    
Total operating expenses  4,824,000   4,365,000   13,531,000   13,602,000 
                 
Operating loss  (8,956,000)  (1,592,000)  (14,494,000)  (353,000)
                 
Other income (expense):                
Interest and other income  42,000   25,000   83,000   71,000 
Interest and other expense  (14,000)  (2,000)  (18,000)  (2,000)
                 
Loss from continuing operations $(8,928,000) $(1,569,000) $(14,429,000) $(284,000)
Loss from discontinued operations  (2,076,000)  (6,205,000)  (10,404,000)  (22,603,000)
Net loss $(11,004,000) $(7,774,000) $(24,833,000) $(22,887,000)
                 
Comprehensive loss $(11,004,000) $(7,774,000) $(24,833,000) $(22,887,000)
                 
Series E preferred stock accumulated dividends  (1,442,000)  (1,442,000)  (3,604,000)  (3,558,000)
                 
Net loss attributable to common stockholders $(12,446,000) $(9,216,000) $(28,437,000) $(26,445,000)
                 
Basic and diluted weighted average common shares outstanding(1):  45,225,804   37,258,794   45,032,335   35,486,782 
                 
Basic and diluted net loss per common share attributable to common stockholders(1):                
Continuing operations $(0.23) $(0.08) $(0.40) $(0.11)
Discontinued operations $(0.05) $(0.17) $(0.23) $(0.64)
Net loss per share attributable to common stockholders $(0.28)  (0.25) $(0.63) $(0.75)

                 
  

Three Months Ended

October 31,

  

Six Months Ended

October 31,

 
  2021  2020  2021  2020 
             
Revenues $26,109  $21,064  $56,863  $46,456 
Cost of revenues  16,923   14,646   36,286   31,494 
Gross profit  9,186   6,418   20,577   14,962 
                 
Operating expenses:                
Selling, general and administrative  5,033   4,166   9,493   7,991 
Total operating expenses  5,033   4,166   9,493   7,991 
Operating income  4,153   2,252   11,084   6,971 
Interest and other income, net  73   32   149   47 
Interest expense  (704)  0   (1,407)  (4)
Net income $3,522  $2,284  $9,826  $7,014 
Comprehensive income $3,522  $2,284  $9,826  $7,014 
Series E preferred stock accumulated dividends  0   (1,442)  0   (2,523)
Net income attributable to common stockholders $3,522  $842  $9,826  $4,491 
                 
Net income per share attributable to common stockholders:                
Basic $0.06  $0.01  $0.16  $0.08 
Diluted $0.06  $0.01  $0.15  $0.08 
                 
Weighted average common shares outstanding:
                
Basic  61,414   56,660   61,276   56,592 
Diluted  63,602   57,248   63,606   57,073 

 

(1) All share andSee accompanying notes to condensed consolidated financial statements.

2

avid bioservices, INC.

CONDENSED CONSOLIDATED STATEMENTS of STOCKHOLDERs’ EQUITY

(Unaudited) (In thousands, except per share amounts of our common stock for all prior fiscal year periods presented have been retroactively adjusted to reflect the one-for-seven reverse stock split of our issued and outstanding common stock, which took effect on July 10, 2017 (Note 1).information)

 

                             
  Three Months Ended October 31, 2021 
  Preferred Stock  Common Stock  Additional Paid-In  Accumulated   Total Stockholders’ 
  Shares  Amount  Shares  Amount  Capital  

Deficit

  Equity 
Balance at July 31, 2021    $   61,341  $61  $597,320  $(552,745) $44,636 
Common stock issued under equity compensation plans        211   1   1,004      1,005 
Stock-based compensation expense              1,942      1,942 
Net income                 3,522   3,522 
Balance at October 31, 2021    $   61,552  $62  $600,266  $(549,223) $51,105 

  Three Months Ended October 31, 2020 
  Preferred Stock  Common Stock  Additional Paid-In  Accumulated  Total Stockholders’ 
  Shares  Amount  Shares  Amount  Capital  

Deficit

  Equity 
Balance at July 31, 2020  1,648  $2   56,601  $56  $612,822  $(566,341) $46,539 
Series E preferred stock dividends paid ($0.65625 per share)              (1,081)     (1,081)
Common stock issued under equity compensation plans        121   1   618      619 
Stock-based compensation expense              1,025      1,025 
Net income                 2,284   2,284 
Balance at October 31, 2020  1,648  $2   56,722  $57  $613,384  $(564,057) $49,386 

See accompanying notes to condensed consolidated financial statements.

3

avid bioservices, INC.

CONDENSED CONSOLIDATED STATEMENTS of STOCKHOLDERs’ EQUITY (Continued)

(Unaudited) (In thousands, except per share information)

  Six Months Ended October 31, 2021 
  Preferred Stock  Common Stock  Additional
Paid-In
  Accumulated  Total
Stockholders’
 
  Shares  Amount  Shares  Amount  Capital  

Deficit

  Equity 
Balance at April 30, 2021    $   61,069  $61  $637,534  $(559,859) $77,736 
Cumulative-effect adjustment from modified retrospective adoption of ASU 2020-06              (42,431)  810   (41,621)
Common stock issued under equity compensation plans        483   1   1,922      1,923 
Stock-based compensation expense              3,241      3,241 
Net income                 9,826   9,826 
Balance at October 31, 2021    $   61,552  $62  $600,266  $(549,223) $51,105 

  Six Months Ended October 31, 2020 
  Preferred Stock  Common Stock  Additional
Paid-In
  Accumulated  Total
Stockholders’
 
  Shares  Amount  Shares  Amount  Capital  

Deficit

  Equity 
Balance at April 30, 2020  1,648  $2   56,483  $56  $612,909  $(571,071) $41,896 
Series E preferred stock dividends paid ($1.3125 per share)              (2,162)     (2,162)
Common stock issued under equity compensation plans        239   1   882      883 
Stock-based compensation expense              1,755      1,755 
Net income                 7,014   7,014 
Balance at October 31, 2020  1,648  $2   56,722  $57  $613,384  $(564,057) $49,386 

See accompanying notes to condensed consolidated financial statements.

4

avid bioservices, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited) (In thousands)

         
  

Six Months Ended

October 31,

 
  2021  2020 
       
CASH FLOWS FROM OPERATING ACTIVITIES:        
Net income $9,826  $7,014 
Adjustments to reconcile net income to net cash used in operating activities:        
Stock-based compensation  3,241   1,755 
Depreciation and amortization  2,036   1,684 
Amortization of debt issuance costs  509   0 
Changes in operating assets and liabilities:        
Accounts receivable, net  705   (2,962)
Contract assets  2,692   (2,043)
Inventory  (8,439)  1,160 
Prepaid expenses and other assets  (2,742)  (293)
Accounts payable  (1,745)  (2,103)
Accrued payroll and related costs  (3,741)  1,831 
Contract liabilities  1,096   2,330 
Other accrued expenses and liabilities  223   (240)
Net cash provided by operating activities  3,661   8,133 
         
CASH FLOWS FROM INVESTING ACTIVITIES:        
Purchase of property and equipment  (11,824)  (2,980)
Net cash used in investing activities  (11,824)  (2,980)
         
CASH FLOWS FROM FINANCING ACTIVITIES:        
Proceeds from issuance of common stock under equity compensation plans  1,923   883 
Repayment of note payable  0   (4,379)
Dividends paid on preferred stock  0   (2,162)
Principal payments on finance lease  0   (93)
Net cash provided by (used in) financing activities  1,923   (5,751)
         
Net decrease in cash, cash equivalents and restricted cash  (6,240)  (598)
Cash, cash equivalents and restricted cash, beginning of period  170,265   36,612 
Cash, cash equivalents and restricted cash, end of period $164,025  $36,014 
         
Supplemental disclosures of non-cash activities:        
Unpaid purchases of property and equipment $2,493  $1,831 
Right-of-use assets obtained upon operating lease modification, net $4,554  $0 
Right-of-use assets obtained in exchange for operating lease obligations $16,093  $0 
Property and equipment obtained in exchange for finance lease obligation $2,760  $0 

The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the unaudited condensed consolidated balance sheets that sum to the total of the same amounts shown above:

                 
  

October 31,

2021

  

April 30,

2021

  

October 31,

2020

  

April 30,

2020

 
Cash and cash equivalents $163,675  $169,915  $35,664  $36,262 
Restricted cash  350   350   350   350 
Total cash, cash equivalents and restricted cash $164,025  $170,265  $36,014  $36,612 

See accompanying notes to condensed consolidated financial statements.

 

 

 

 25 

 

 

avid bioservices, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)

  

Nine Months Ended

January 31,

 
  2018  2017 
       
CASH FLOWS FROM OPERATING ACTIVITIES:        
Net loss $(24,833,000) $(22,887,000)
Adjustments to reconcile net loss to net cash used in operating activities:        
Share-based compensation  1,206,000   2,591,000 
Depreciation and amortization  1,945,000   1,850,000 
Loss on disposal of property and equipment  401,000    
Changes in operating assets and liabilities:        
Trade and other receivables  (225,000)  (3,024,000)
Inventories  18,881,000   (17,643,000)
Prepaid expenses  554,000   (396,000)
Other non-current assets  9,000   233,000 
Accounts payable  (3,895,000)  (1,153,000)
Accrued clinical trial and related fees  945,000   (4,467,000)
Accrued payroll and related expenses  (2,208,000)  (184,000)
Deferred revenue  (21,867,000)  16,337,000 
Customer deposits  585,000   1,998,000 
Other accrued expenses and current liabilities  (64,000)  (801,000)
Deferred rent, less current portion  465,000   (70,000)
         
Net cash used in operating activities  (28,101,000)  (27,616,000)
         
CASH FLOWS FROM INVESTING ACTIVITIES:        
Property and equipment acquisitions  (2,129,000)  (2,644,000)
(Increase) decrease in other assets  (15,000)  205,000 
         
Net cash used in investing activities  (2,144,000)  (2,439,000)
         
CASH FLOWS FROM FINANCING ACTIVITIES:        
Proceeds from issuance of common stock, net of issuance costs of $111,000 and $340,000, respectively  4,193,000   11,604,000 
Proceeds from issuance of Series E preferred stock, net of issuance costs of nil and $58,000, respectively     1,576,000 
Proceeds from issuance of common stock under Employee Stock Purchase Plan  217,000   254,000 
Proceeds from exercise of stock options  398,000    
Dividends paid on Series E preferred stock  (3,244,000)  (3,198,000)
Principal payments on capital lease  (180,000)  (65,000)
Net cash provided by financing activities  1,384,000   10,171,000 
         
NET DECREASE IN CASH AND CASH EQUIVALENTS  (28,861,000)  (19,884,000)
         
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD  46,799,000   61,412,000 
         
CASH AND CASH EQUIVALENTS AT END OF PERIOD $17,938,000  $41,528,000 
         
SCHEDULE OF NON-CASH INVESTING AND FINANCING ACTIVITIES:        
Accounts payable for purchase of property and equipment $27,000  $420,000 
Property and equipment acquired under capital lease $  $319,000 

See accompanying notes to condensed consolidated financial statements.

3

avid bioservices, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE nine MONTHS ENDED january 31, 2018 (unaudited)

(UNAUDITED)

 

1.       ORGANIZATION AND BUSINESS

Note 1 – Description of Company and Basis of Presentation

 

Business DescriptionWe are a dedicated contract development and manufacturing organization (“CDMO”) that provides a comprehensive range of services from process development to currentCurrent Good Manufacturing Practices (“cGMP”CGMP”) clinical and commercial manufacturing, focused on biopharmaceutical products derived from mammalian cell culturedevelopment and CGMP manufacturing of biologics for the biotechnology and pharmaceutical companies.biopharmaceutical industries.

 

Sale of Research and Development Assets—On February 12, 2018, we entered into an Asset Assignment and Purchase Agreement with a third-party oncology therapeutics company pursuant to which we sold to the third-party oncology therapeutics company the majority of our research and development assets, which included the assignment of certain exclusive licenses related to our former phosphatidylserine (PS)-targeting program (Note 10). As a result of (i) the sale of our PS-targeting program, (ii) the held for sale classification of our R84 technology, (iii) the abandonment of our remaining research and development assets (including our intent to return the exosome technology back to the original licensor), and (iv) the strategic shift in our corporate direction to focus solely on our CDMO business, the operating results from our research and development segment are reported as a loss from discontinued operations in the accompanying unaudited condensed consolidated financial statements for all periods presented (Note 2).

Corporate Name Change—Effective January 5, 2018, we changed our name from Peregrine Pharmaceuticals, Inc. to Avid Bioservices, Inc. in connection with the strategic shift in our corporate direction.

Reverse Stock Split—On July 7, 2017, we effected a reverse stock split of our outstanding shares of common stock at a ratio of one-for-seven pursuant to our filed Certificate of Amendment to our Certificate of Incorporation with the Secretary of State of the State of Delaware. The reverse stock split took effect with the opening of trading on July 10, 2017. The primary purpose of the reverse stock split, which was approved by our stockholders at our 2016 Annual Meeting on October 13, 2016, was to enable us to regain compliance with the $1.00 minimum bid price requirement for continued listing on The NASDAQ Capital Market. Pursuant to the reverse stock split, every seven shares of our issued and outstanding shares of common stock were automatically combined into one issued and outstanding share of common stock, without any change in the par value per share of our common stock. All share and per share amounts of our common stock included in the accompanying unaudited condensed consolidated financial statements have been retrospectively adjusted to give effect to the reverse stock split for all periods presented, including reclassifying an amount equal to the reduction in par value to additional paid-in capital. No fractional shares were issued in connection with the reverse stock split. Any fractional share of common stock created by the reverse stock split was rounded up to the nearest whole share. The number of authorized shares of our common stock remained unchanged.

The reverse stock split affected all issued and outstanding shares of our common stock, as well as the shares of common stock underlying our stock options, employee stock purchase plan, warrants and the general conversion right with respect to our 10.50% Series E Convertible Preferred Stock (the “Series E Preferred Stock”).

2.       SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation

 

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with United Statesaccounting principles generally accepted accounting principlesin the United States (“U.S. GAAP”) and with the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) related to quarterly reports on Form 10-Q. Accordingly,10-Q, and accordingly, they do not include all of the information and disclosures required by U.S. GAAP for a complete set ofannual financial statements. These unaudited condensed consolidated financial statements and notes thereto should be read in conjunction with the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the fiscal year ended April 30, 2017. The condensed consolidated balance sheet at April 30, 2017 has been derived from audited financial statements at that date.2021, as filed with the SEC on June 29, 2021. The unaudited financial information for the interim periods presented herein reflects all adjustments which, in the opinion of management, are necessary for a fair presentation of the financial condition and results of operations for the periods presented, with such adjustments consisting only of normal recurring adjustments. Results of operations for interim periods covered by this Quarterly Report on Form 10-Q may not necessarily be indicative of results of operations for the full fiscal year or any other interim period.

 

4

avid bioservices, inc.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE NINE MONTHS ENDED JANUARY 31, 2018 (unaudited) (CONTINUED)

The unaudited condensed consolidated financial statements include the accounts of Avid Bioservices, Inc., and its subsidiaries.subsidiary. All intercompany accounts and transactions among the consolidated entities have been eliminated in the unaudited condensed consolidated financial statements.

 

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts, as well as disclosures of commitments and contingencies in the financial statements and accompanying notes. Actual results could differ materially from those estimates and assumptions.

 

Discontinued OperationsNote 2 – Summary of Significant Accounting Policies

 

AsInformation regarding our significant accounting policies is contained in Note 2, “Summary of January 31, 2018, our research and development segment met allSignificant Accounting Policies”, of the conditions to be classified as a discontinued operation (Note 1). Accordingly, the operating results of our research and development segment are reported as a loss from discontinued operations in the accompanying unaudited condensed consolidated financial statements for all periods presented. For additional information, see Note 10, “Sale of Research and Development Assets”.

Going Concern

The accompanying condensed consolidated 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. The financial statements do not include any adjustments relating to the recoverability of the recorded assets or the classification of liabilities that may be necessary should it be determined that we are unable to continue as a going concern.

We have expended substantial funds on our contract manufacturing business and, historically, on the research and development of pharmaceutical product candidates. As a result, we have historically experienced losses and negative cash flows from operations since our inception and, although we have discontinued our research and development segment (Note 1), we expect negative cash flows from operations to continue for the foreseeable future until we can generate sufficient revenue to achieve profitability. Therefore, unless and until we are able to generate sufficient revenue, we expect such losses to continue during the remainder of fiscal year 2018 and in the foreseeable future.

Our ability to fund our operations is dependent on the amount of cash on hand and our ability to generate sufficient revenue to cover our operations. At January 31, 2018, we had $17,938,000 in cash and cash equivalents and during February 2018, we raised $23,163,000 in gross proceeds from the sale of our common stock pursuant to an underwritten public offering (Note 13). In addition, we expect to receive an aggregate of $8,000,000 in upfront payments over the next six (6) months from the recent sale of certain of our research and development assets (Note 10).

In the event we are unable to secure sufficient business to support our operations beyond the next twelve months, we may need to raise additional capital in the future. Our ability to raise additional capital in the equity markets to fund our obligations in future periods is dependent on a number of factors, including, but not limited to, the market demand for our common stock. The market demand or liquidity of our common stock is subject to a number of risks and uncertainties, including but not limited to, negative economic conditions, adverse market conditions, and adverse financial results. If we are unable to either raise sufficient capital in the equity markets or generate additional revenue, we may need to further restructure, or cease, our operations. In addition, even if we are able to raise additional capital, it may not be at a price or on terms that are favorable to us.

As a result, we have concluded that there is substantial doubt about our ability to continue as a going concern within one year after the date that our accompanying unaudited condensed consolidated financial statements are issued.

Reclassification

Certain prior year amounts related to other assets have been reclassified to property and equipment in our accompanying condensed consolidated balance sheetAnnual Report on Form 10-K for the fiscal year ended April 30, 2017 and in our accompanying unaudited condensed consolidated statement of cash flows for the nine months ended January 31, 2017 to conform to the current period presentation. This reclassification had no effect on previously reported net loss.

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avid bioservices, inc.2021.

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE NINE MONTHS ENDED JANUARY 31, 2018 (unaudited) (CONTINUED)Revenue Recognition

 

Revenue recognized from services provided under our customer contracts are disaggregated into manufacturing and process development revenue streams.

In addition, certain amounts related

Manufacturing revenue

Manufacturing revenue generally represents revenue from the manufacturing of customer products recognized over time utilizing an input method that compares the cost of cumulative work-in-process to corporate overhead costs that were allocateddate to the researchmost current estimates for the entire cost of the performance obligation. Under a manufacturing contract, a quantity of manufacturing runs are ordered at a specified scale with prescribed delivery dates, where the product is manufactured according to the customer’s specifications and development segmenttypically includes only one performance obligation. Each manufacturing run represents a distinct service that is sold separately and has stand-alone value to the customer. The products are manufactured exclusively for a specific customer and have been reclassified from researchno alternative use. The customer retains control of its product during the entire manufacturing process and development expensecan make changes to selling, general and administrative expense in our accompanying unaudited condensed consolidated statements of operations and comprehensive loss for all periods presented (Note 10). This reclassification had no effect on previously reported net loss.

Restructuring

Restructuring charges consist of one-time termination benefits, including severance and other employee related costs related to a workforce reduction pursuant to a restructuring plan we implemented in August 2017 (Note 9). One-time termination benefits are expensedthe process or specifications at the date we notified the employee, unless the employee was required to provide future service, in which case the benefits are expensed ratably over the future service period.

Cash and Cash Equivalents

We consider all short-term investments readily convertible to cash with an initial maturity of three months or less to be cash equivalents.

Restricted Cash

its request. Under the terms of three separate operating leases related to our facilities,these agreements, we are requiredentitled to maintain, as collateral, lettersconsideration for progress to date that includes an element of credit during the terms of such leases. At January 31, 2018 and April 30, 2017, restricted cash of $1,150,000 was pledged as collateral under these letters of credit.

Concentrations of Credit Risk and Customer Base

Financial instruments that potentially subject us to a significant concentration of credit risk consist of cash and cash equivalents, restricted cash and trade receivables. We maintain our cash and restricted cash balances primarily with one major commercial bank and our deposits held with the bank exceed the amount of government insurance limits provided on our deposits. We are exposed to credit risk in the event of default by the major commercial bank holding our cash and restricted cash balances to the extent of the cash and restricted cash amounts recorded on the accompanying unaudited condensed consolidated balance sheet.

Our trade receivables from amounts billed for contract manufacturing services have historically been derived from a small customer base. Most contracts require up-front payments and installment payments during the service period. We perform periodic evaluations of the financial condition of our customers and generally do not require collateral, but we can terminate any contract if a material default occurs. At January 31, 2018 and April 30, 2017, approximately 94% and 93%, respectively, of our trade receivables were due from four customers.

In addition, contract manufacturing revenue has historically been derived from a small customer base. Historically, these customers have not entered into long-term contracts because their need for drug supply depends on a variety of factors, including the product’s stage of development, the timing of regulatory filings and approvals, the product needs of their collaborators, if applicable, their financial resources and the market demand with respect to commercial products. During the three and nine months ended January 31, 2018, approximately, 53% and 78%, respectively, of our contract manufacturing revenue was derived from our two largest customers.

Based on our current commitments for manufacturing services from our two largest customers, we expect our future results of operations to be adversely affected until we are able to further expand and diversify our customer base.

Comprehensive Loss

Comprehensive loss is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Comprehensive loss is equal to our net loss for all periods presented.

profit margin.

 

 

 6 

 

 

avid bioservices, inc.INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE NINE MONTHS ENDED JANUARY 31, 2018 (unaudited) (CONTINUED)

(UNAUDITED)

 

 

Process development revenue

Process development revenue generally represents revenue from services associated with the custom development of a manufacturing process and analytical methods for a customer’s product. Process development revenue is recognized over time utilizing an input method that compares the cost of cumulative work-in-process to date to the most current estimates for the entire cost of the performance obligation. Under a process development contract, the customer owns the product details and process, which has no alternative use. These process development projects are customized to each customer to meet its specifications and typically includes only one performance obligation. Each process represents a distinct service that is sold separately and has stand-alone value to the customer. The customer also retains control of its product as the product is being created or enhanced by our services and can make changes to its process or specifications upon request. Under these agreements, we are entitled to consideration for progress to date that includes an element of profit margin.

The following table summarizes our manufacturing and process development revenue streams (in thousands): 

Disaggregation of revenue                
  

Three Months Ended

October 31,

  

Six Months Ended

October 31,

 
  2021  2020  2021  2020 
Manufacturing revenues $22,013  $18,449  $47,688  $42,512 
Process development revenues  4,096   2,615   9,175   3,944 
Total revenues $26,109  $21,064  $56,863  $46,456 

The timing of revenue recognition, billings and cash collections results in billed accounts receivable, contract assets (unbilled receivables) and contract liabilities (customer deposits and deferred revenue). Contract assets are recorded when our right to consideration is conditioned on something other than the passage of time. Contract assets are reclassified to accounts receivable on the balance sheet when our rights become unconditional. Contract liabilities represent customer deposits and deferred revenue billed and/or received in advance of our fulfillment of performance obligations. Contract liabilities convert to revenue as we perform our obligations under the contract.

During the three and six months ended October 31, 2021, we recognized revenue of $7.3 million and $24.8 million, respectively, for which the contract liability was recorded in a prior period.

During the three and six months ended October 31, 2020, we recognized revenue of $6.3 million and $22.7 million, respectively, for which the contract liability was recorded in a prior period.

The transaction price for services provided under our customer contracts reflects our best estimates of the amount of consideration to which we are entitled in exchange for providing goods and services to our customers. In determining the transaction price, we considered the different sources of variable consideration including, but not limited to, discounts, credits, refunds, price concessions or other similar items. We have included in the transaction price some or all of an amount of variable consideration, utilizing the most likely method, only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The actual amount of consideration ultimately received may differ.

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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

In addition, our customer contracts generally include provisions entitling us to a cancellation or postponement fee when a customer cancels or postpones its commitments prior to our initiation of services, therefore not utilizing their reserved capacity. The determination of such cancellation and postponement fees are based on the terms stated in the related customer contract but are generally considered substantive for accounting purposes and create an enforceable right and obligation due to us when the cancellation or postponement occurs. Accordingly, we recognize such fees, subject to variable consideration, as revenue upon the cancellation or postponement date utilizing the most likely method.

Management may be required to exercise judgement in estimating revenue to be recognized. Judgement is required in identifying performance obligations, estimating the transaction price, estimating the stand-alone selling prices of identified performance obligations, estimating variable consideration, and estimating the progress towards the satisfaction of performance obligations. If actual results in the future vary from our estimates, the estimates will be adjusted, which will affect revenues in the period that such variances become known.

During the three and six months ended October 31, 2021, we reduced the amount of revenue recognized as a result of estimated variable consideration related to a dispute with a customer over the payment of certain cancellation fees due to us under the terms of the related customer contract which resulted in a decrease in revenues of $11.2 million. We believe we have a contractual right to this amount, but as this contractual right is being disputed by our customer and therefore may be uncollectible, we have not recorded revenue associated with the disputed amount. During the three and six months ended October 31, 2020, changes in estimates for variable consideration resulted in an increase in revenues of $1.7 million and $1.1 million, respectively.

We apply the practical expedient available under ASC 606 that permits us not to disclose the value of unsatisfied performance obligations for contracts with an original expected length of one year or less. As of October 31, 2021, we do not have any unsatisfied performance obligations for contracts greater than one year.

Restricted Cash

Under the terms of an operating lease related to one of our facilities (Note 4), we are required to maintain a letter of credit as collateral. Accordingly, at October 31, 2021 and April 30, 2021, restricted cash of $0.4 million was pledged as collateral under the letter of credit.

Accounts Receivable

Accounts receivable are primarily comprised of amounts owed to us for services provided under our customer contracts and are recorded at the invoiced amount net of an allowance for doubtful accounts, if necessary. We apply judgement in assessing the ultimate realization of our receivables and we estimate an allowance for doubtful accounts based on various factors, such as the aging of our receivables, historical experience, and the financial condition of our customers.

Based on our analysis of our accounts receivable balance as of April 30, 2021, we determined 0 allowance for doubtful accounts was deemed necessary.

Based on our analysis of our accounts receivable balance as of October 31, 2021, we determined an allowance for doubtful accounts of $11.2 million was deemed necessary due to a dispute with a customer over the payment of certain cancellation fees due to us under the terms of the related customer contract. The corresponding amount of revenue was reserved in the period. We believe we have a contractual right to this amount, but as this contractual right is being disputed by our customer and therefore may be uncollectible, we have chosen to reserve the disputed amount.

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avid bioservices, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

Leases

We determine if an arrangement is or contains a lease at inception. Our operating leases with a term greater than one year are included in operating lease right-of-use (“ROU”) assets, current portion of operating lease liabilities and operating lease liabilities, less current portion in our consolidated balance sheets. ROU assets represent our right to use an underlying asset during the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at the lease commencement date, based on the present value of lease payments over the lease term. In determining the net present value of lease payments, we use our incremental borrowing rate which represents an estimated rate of interest that we would have to pay to borrow equivalent funds on a collateralized basis at the lease commencement date.

Our operating leases may include options to extend the lease which are included in the lease term when it is reasonably certain that we will exercise a renewal option. Operating lease expense is recognized on a straight-line basis over the expected lease term.

For our finance lease, which has a term greater than one year, an asset is included within property and equipment, net and a lease liability equal to the present value of the minimum lease payments is included in other current liabilities and finance lease liabilities, less current portion in our consolidated balance sheets. The present value of the finance lease payments are calculated using the implicit interest rate in the lease.

We have elected not to apply the recognition requirements of ASC 842 for short-term leases. We have also elected the practical expedient to not separate lease components from non-lease components.

Inventory

Inventory consists of raw materials inventory and is valued at the lower of cost, determined by the first-in, first-out method, or net realizable value. We periodically review raw materials inventory for potential impairment and adjust inventory to its net realizable value based on the estimate of future use and reduce the carrying value of inventory as deemed necessary.

Property and Equipment

Property and equipment is recorded at cost, less accumulated depreciation and amortization. Depreciation and amortization are computed using the straight-line method over the estimated useful lives of the related asset, which are generally as follows: 

Schedule of estimated useful lives of property
DescriptionEstimated Useful Life
Leasehold improvementsShorter of estimated useful life or lease term
Laboratory and manufacturing equipment5 – 10 years
Computer equipment and software3 – 5 years
Furniture, fixtures and office equipment5 – 10 years

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avid bioservices, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

Construction-in-progress, which represents direct costs related to the construction of various equipment and leasehold improvements primarily associated with our manufacturing facilities, is not depreciated until the asset is completed and placed into service. No interest was incurred or capitalized as construction-in-progress as of October 31, 2021 and April 30, 2021. All of our property and equipment are located in the United States. Property and equipment consist of the following (in thousands): 

Schedule of property and equipment        
  October 31, 2021  April 30, 2021 
Leasehold improvements $23,000  $23,000 
Laboratory and manufacturing equipment  23,998   20,793 
Computer equipment and software  5,541   5,541 
Furniture, fixtures and office equipment  843   843 
Construction-in-progress  22,083   8,372 
Total property and equipment, gross  75,465   58,549 
Less: accumulated depreciation and amortization  (22,969)  (21,094)
Total property and equipment, net $52,496  $37,455 

Depreciation and amortization expense for the three and six months ended October 31, 2021 was $1.0 million and $2.0 million, respectively.

Depreciation and amortization expense for the three and six months ended October 31, 2020 was $0.9 million and $1.7 million, respectively.

Impairment

 

Long-lived assets are reviewed for impairment in accordance with authoritative guidance for impairment or disposal of long-lived assets. Long-lived assets are reviewed for events or changes in circumstances whichthat indicate that their carrying value may not be recoverable. Long-livedIf such events or changes in circumstances arise, we compare the carrying amount of the long-lived assets to the estimated future undiscounted cash flows expected to be generated by the long-lived assets. If the long-lived assets are reported atdetermined to be impaired, any excess of the lowercarrying value of carrying amount orthe long-lived assets over its estimated fair value less cost to sell.is recognized as an impairment loss. For the ninesix months ended JanuaryOctober 31, 20182021 and 2017,2020, there were no0 indicators of impairment of the value of our long-lived assets.assets and no cumulative impairment losses recognized as of October 31, 2021.

 

Stock-Based Compensation

We account for stock options, restricted stock units, performance stock units and other stock-based awards granted under our equity compensation plans in accordance with the authoritative guidance of ASC 718, Compensation – Stock Compensation. The estimated fair value of stock options granted to employees in exchange for services is measured at the grant date, using a fair value based method, such as a Black-Scholes option valuation model, and is recognized as expense on a straight-line basis over the requisite service periods. The fair value of restricted stock units and performance stock units is measured at the grant date based on the closing market price of our common stock on the date of grant. For restricted stock units, the fair value is recognized as expense on a straight-line basis over the requisite service periods. For performance stock units, which are subject to performance conditions, the fair value is recognized as expense on a straight-line basis over the requisite service periods when the achievement of such performance condition is determined to be probable. If a performance condition is not determined to be probable or is not met, no stock-based compensation expense is recognized, and any previously recognized expense is reversed. Forfeitures are recognized as a reduction of stock-based compensation expense as they occur.

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avid bioservices, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

Comprehensive Income

Comprehensive income is the change in equity during a period from transactions and other events and circumstances from non-owner sources. Comprehensive income is equal to our net income for all periods presented.

Fair Value Measurements

 

Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The guidance prioritizes the inputs used in measuring fair value into the following hierarchy:

 

·Level 1 – Observable inputs, such as unadjusted quoted prices in active markets for identical assets or liabilities.
·Level 2 – Observable inputs other than quoted prices included in Level 1, such as assets or liabilities whose values are based on quoted market prices in markets where trading occurs infrequently or whose values are based on quoted prices of instruments with similar attributes in active markets.
·Level 3 – Unobservable inputs that are supported by little or no market activity and significant to the overall fair value measurement of the assets or liabilities; therefore, requiring the company to develop its own valuation techniques and assumptions.

 

As of JanuaryOctober 31, 20182021 and April 30, 2017,2021, we dodid not have any Level 2 or Level 3 financial assets or liabilities and our cash equivalents which are primarilyof $155.4 million and $158.8 million, respectively, were invested in money market funds with one and two major commercial bank, arebanks, respectively, and carried at fair value based on quoted market prices for identical securities (Level 1 input). In addition, there were no transfers between any Levels ofWe consider the fair value hierarchy duringof our convertible senior notes to be a Level 2 financial liability due to limited trading activity of the threesenior convertible notes. Refer to Note 3, Debt, of the Notes to Condensed Consolidated Financial Statements for further details. We did not have any other Level 2 or Level 3 financial liabilities as of October 31, 2021 and nine months ended January 31, 2018 and 2017.April 30, 2021.

 

Customer DepositsRecent Accounting Pronouncements

 

Customer deposits primarily represent advance billings and/or payments receivedIn June 2016, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses of Financial Instruments (“ASU 2016-13”). The standard changes the methodology for services or raw materials frommeasuring credit losses on financial instruments and the timing of when such losses are recorded. As a smaller reporting company as defined by the SEC, ASU 2016-13 and its subsequent updates are effective for fiscal years beginning after December 15, 2022, which will be our third-party customers prior tofiscal year 2024 beginning May 1, 2023; however, early adoption is permitted. We are currently evaluating the initiation of contract manufacturing services.timing and the impact this standard will have on our condensed consolidated financial statements.

 

Revenue RecognitionIn December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which simplifies the accounting for income taxes by removing certain exceptions and improving consistent application in certain areas of Topic 740. ASU 2019-12 is effective for fiscal years, and interim periods within those years, beginning after December 15, 2020, which will be our fiscal year 2022 beginning May 1, 2021. Early adoption is permitted. We adopted ASU 2019-12 on May 1, 2021 and the adoption of this standard did not have a material impact on our condensed consolidated financial statements.

 

We derive revenue from contract manufacturing services provided to our third-party customers. We recognize revenueIn August 2020, the FASB issued ASU No. 2020-06, Debt with Conversion and other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in accordance withEntity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”). The amendments in this ASU will eliminate the authoritative guidancebeneficial conversion and cash conversion accounting models for revenue recognition when all ofconvertible instruments, as well as, amend the following criteria are met: (i) persuasive evidence ofaccounting for certain contracts in an arrangement exists, (ii) delivery has occurred or services have been rendered, (iii) the seller’s price to the buyer is fixed or determinable, and (iv) collectability is reasonably assured. We also comply with the authoritative guidance for revenue recognition regarding arrangements with multiple elements.

Revenue arrangements with multiple elements are divided into separate units of accounting if certain criteria are met, including whether the delivered element has stand-alone value to the customer. When deliverables are separable, consideration received is allocated among the separate units based on their respective fair values, and the applicable revenue recognition criteria are applied to each of the separate units, which may require the use of significant judgement. Deliverables are considered separate units of accounting if (1) the delivered item(s) has value to the customer on a stand-alone basis and (2) the arrangement includes a general right of return relative to the delivered item(s), delivery or performance of the undelivered item(s) is considered probable and substantially in our control.

Arrangement consideration is allocated at the inception of the agreement to all identified units of accounting based on their relative selling price. The relative selling price for each deliverable is determined using vendor specific objective evidence (“VSOE”) of selling price or third-party evidence of selling price if VSOE does not exist. If neither VSOE nor third-party evidence of selling price exists, we use our best estimate of the selling price for the deliverable. The amount of allocable arrangement consideration is limited to amountsentity’s own equity that are fixedcurrently accounted for as derivatives because of specific settlement provisions. The ASU will also modify how particular convertible instruments and certain contracts that may be settled in cash or determinable. The consideration receivedshares impact the diluted earnings per share calculation. As a smaller reporting company as defined by the SEC, ASU 2020-06 is allocated among the separate units of accounting,effective for fiscal years, and the applicable revenue recognition criteria are applied to each of the separate units. Changes in the allocation of the sales price between delivered and undelivered elements can impact revenue recognitioninterim periods within those years, beginning after December 15, 2023, which will be our fiscal year 2025 beginning May 1, 2024. Early adoption is permitted, but do not change the total revenue recognized under any agreement.no earlier than fiscal years beginning after December 15, 2020.

 

 

 

 711 

 

 

avid bioservices, inc.INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE NINE MONTHS ENDED JANUARY (UNAUDITED)

We elected to early adopt ASU 2020-06 on May 1, 2021 using a modified retrospective transition method. Under this transition method, prior period financial information and disclosures are not adjusted and continue to be reported under the accounting standards that were in effect prior to our adoption of ASU 2020-06.

The adoption of ASU 2020-06 resulted in the re-combination of the debt and equity components of our convertible senior notes (Note 3) into a single debt instrument, which resulted in a $42.4 million decrease in additional paid-in capital from the derecognition of the bifurcated equity component, a $41.6 million increase in convertible senior notes from the derecognition of the discount associated with the bifurcated equity component, or debt discount, and $0.8 million decrease to the opening balance of accumulated deficit, representing the cumulative non-cash interest expense recognized related to the amortization of the debt discount associated with the bifurcated equity component of our convertible senior notes. The adoption of this standard also reduces the non-cash interest expense recognized in future periods due to the derecognition of the debt discount associated with the bifurcated equity component of our convertible senior notes. When calculating net income per share of common stock attributable to common stockholders, we use the if-converted method as required under ASU 2020-06 to determine the dilutive effect of our convertible senior notes.

Note 3 – Debt

Convertible Senior Notes

In March 2021, we issued $143.8 million in aggregate principal amount of 1.250% exchangeable senior notes due 2026 (“Convertible Notes”) in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act, which aggregate principal amount included the $18.8 million issued pursuant to the initial purchasers’ full exercise of their option to purchase additional principal amount of Convertible Notes. The net proceeds we received from the issuance of Convertible Notes was $138.5 million, after deducting initial purchaser discounts and other debt issuance related expenses of $5.3 million.

The Convertible Notes are senior unsecured obligations and accrue interest at a rate of 1.250% per annum, payable semi-annually in arrears on March 15 and September 15 of each year, beginning on September 15, 2021. The Convertible Notes mature on March 15, 2026, unless earlier redeemed or repurchased by us or converted at the option of the holders. The Convertible Notes are convertible into cash, shares of our common stock or a combination of cash and shares of our common stock, at our election in the manner and subject to the terms and conditions provided in the indenture (the “Indenture”) governing the Convertible Notes.

The initial conversion rate for the Convertible Notes is approximately 47.1403 shares of our common stock per $1,000 principal amount, which represents an initial conversion price of approximately $21.21 per share of our common stock. The conversion rate is subject to adjustments upon the occurrence of certain events in accordance with the terms of the Indenture. In addition, following certain corporate events that occur prior to the maturity date, we will, in certain circumstances, increase the conversion rate for a holder who elects to convert their Convertible Notes in connection with such a fundamental change, as defined in the Indenture.

Holders of the Convertible Notes may convert their Convertible Notes at their option at any time prior to the close of business on the business day immediately preceding September 15, 2025, only under the following circumstances: (1) During any fiscal quarter commencing after the fiscal quarter ending July 31, 2018 (unaudited) (CONTINUED)2021, if the last reported sale price of our common stock for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding fiscal quarter is greater than or equal to 130% of the conversion price on each applicable trading day; (2) During the five business day period after any five consecutive trading day period (the “measurement period”) in which the trading price (as defined in the Indenture) per $1,000 principal amount of the Convertible Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price of our common stock and the exchange rate on each such trading day; (3) If we call any or all of the Convertible Notes for redemption, at any time prior to the close of business on the second scheduled trading day immediately preceding the redemption date; and (4) Upon the occurrence of specified corporate events as described in the Indenture.

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avid bioservices, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

 

On occasion, we receive requests from customers to hold product that we have manufacturedor after September 15, 2025 until the close of business on a “bill-and-hold” basis. Revenue is recognized for these “bill-and-hold” arrangements in accordance with the authoritative guidance, which requires, among other things,second scheduled trading day immediately preceding the existence of a valid business purpose for the arrangement; the “bill-and-hold” arrangement ismaturity date, holders at the requesttheir option may convert their Convertible Notes at any time, regardless of the customer; title and riskforegoing circumstances.

We may not redeem the Convertible Notes prior to March 20, 2024. On or after March 20, 2024, the Convertible Notes are redeemable for cash, whole or in part, at our option, if the last reported sale price of ownership must pass to the customer; the product is complete and ready for shipment; a fixeddelivery date that is reasonable and consistent with the customer’s business practices; the productour common stock has been separated from our inventory;at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and no further performance obligations byincluding, the trading day immediately preceding the date on which we provide notice of redemption at a redemption price equal to 100% of the principal amount to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.

If we undergo a fundamental change (as defined in the Indenture), holders may require us exist.to repurchase for cash all or any portion of their Convertible Notes at a fundamental change repurchase price equal to 100% of the principal amount of the Convertible Notes to be repurchased, plus accrued and unpaid interest to, but excluding the redemption date.

The Indenture contains customary terms and covenants, including that upon certain events of default occurring and continuing, the trustee or the holders of at least 25% in aggregate principle amount of the outstanding Convertible Notes may declare the entire principal of all the Convertible Notes plus accrued and unpaid interest to be immediately due and payable.

As of October 31, 2021, the conditions allowing holders of the Convertible Notes to convert had not been met and, therefore, the Convertible Notes are classified as a long-term liability on the Condensed Consolidated Balance Sheets at October 31, 2021 and April 30, 2021.

 

In addition, we also followaccounting for the authoritative guidance when reporting revenue as gross when we act as a principal versus reporting revenue as net when we act as an agent. For transactions in which we act as a principal, have discretion to choose suppliers, bear credit and inventory risk and perform a substantive partissuance of the services, revenue is recorded at the gross amount billed to a customer and costs associated with these reimbursements are reflected as a component of cost of sales for contract manufacturing services.

Any amounts receivedConvertible Notes, prior to satisfying our revenue recognition criteria are recorded as deferred revenue or customer deposits in the accompanying unaudited condensed consolidated financial statements. We also recordadoption of ASU 2020-06, we separated the Convertible Notes into debt and equity components. The carrying amount of the debt component on the date of the issuance was $99.7 million and was determined based on a provision for estimated contract losses, if any, in the period inbinomial lattice model, which they are determined.

Share-based Compensation

We account for stock optionsyielded an effective discount rate of 8.78% and other share-based awards granted under our equity compensation plans in accordancewas derived with the authoritative guidance for share-based compensation.assistance of a third-party valuation. The estimatedequity component was allocated a value of $44.1 million, representing the difference between the par value of the Convertible Notes and the fair value of share-based paymentsthe debt component. The equity component was not remeasured as long as it continued to employees in exchangemeet the conditions for services is measuredequity classification, and the equity component was recorded as additional paid-in capital within stockholders’ equity on the Condensed Consolidated Balance Sheet at April 30, 2021. The difference between the grant date,principal amount of the Convertible Notes and the debt component, or the debt discount, was amortized to interest expense using a fair value basedthe effective interest method such as a Black-Scholes option valuation model, and is recognized as expense on a straight-line basis over the requisite service periods. The fair valuecontractual term of modifications to share-based awards, if any, is generally estimated using a Black-Scholes option valuation model, unless a lattice model is required. Forfeitures are recognized as a reduction of share-based compensation expense as they occur. As of January 31, 2018, there were no outstanding share-based awards with market or performance conditions.the Convertible Notes.

 

Income TaxesIn accounting for the issuance costs related to the Convertible Notes, prior to the adoption of ASU 2020-06, we allocated the total amount incurred to the debt and equity components of the Convertible Notes based on their relative values. Issuance costs attributable to the debt component were $3.7 million and are being amortized to interest expense using the effective interest method over the contractual term of the Convertible Notes. Issuance costs attributable to the equity component were $1.6 million and were netted with the equity component in additional paid-in capital within stockholders’ equity on the Condensed Consolidated Balance Sheet at April 30, 2021.

 

On December 22, 2017,May 1, 2021, we elected to early adopt ASU 2020-06 using the U.S. government enacted comprehensive tax legislation commonly referredmodified retrospective transition method. Under such transition method, prior period financial information and disclosures are not adjusted and continue to as the Tax Cuts and Jobs Act (the “Tax Act”). The Tax Act makes broad and complex changes to the U.S. tax code, including, but not limited to, reducing the U.S. federal corporate tax rate from the maximum federal statutory rate of 35% to 21%. The Tax Act states that the 21% U.S. federal corporate tax rate is effective for tax years beginning on or after January 1, 2018. However, existing tax law, which was not amendedbe reported under the Tax Act, governs when a changeaccounting standards that were in tax rate is effective. Existing tax law provides that if the taxable year includes the effective dateeffect prior to our adoption of any rate change (unless the change is the first date of the taxable year), taxes should be calculated by applying a blended rate to the taxable income for the year. Section 15 of the Internal Revenue Code stipulates that our blended federal rate is 29.73% for fiscal year 2018. We have not yet determined the impact the rate reduction will have on our gross deferred tax asset and liabilities and offsetting valuation allowance. However, we have a full allowance against the deferred tax asset and as a result there was no impact to income tax expense for the quarter ended January 31, 2018.ASU 2020-06.

 

In conjunction with the tax law changes, the SEC staff issued Staff Accounting Bulletin No. 118 (“SAB 118”) to address the application of U.S. GAAP in situations when a registrant does not have the necessary information available, prepared, or analyzed (including computations) in reasonable detail to complete the accounting for certain income tax effects of the Tax Act. The ultimate impact, which is expected to be recorded by April 30, 2018, may differ from any provisional amounts, due to, among other things, additional analysis, changes in interpretations and assumptions we have made, additional regulatory guidance that may be issued, and actions we may take as a result of the tax Act, and the fact that we cannot definitively predict what our deferred tax balance will ultimately be as of April 30, 2018.

 

 

 

 813 

 

 

avid bioservices, inc.INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE NINE MONTHS ENDED JANUARY 31, 2018 (unaudited) (CONTINUED)

(UNAUDITED)

 

 

BasicThe adoption of ASU 2020-06 resulted in the re-combination of the debt and Dilutive equity components of the Convertible Notes into a single debt instrument, which resulted in a $42.4 million decrease in additional paid-in capital from the derecognition of the bifurcated equity component, a $41.6 million increase in convertible senior notes, net from the derecognition of the discount associated with the bifurcated equity component, or debt discount, and $0.8 million decrease to the May 1, 2021 opening balance of accumulated deficit, representing the cumulative non-cash interest expense recognized related to the amortization of the debt discount associated with the bifurcated equity component of the Convertible Notes. Additionally, we derecognized the allocation of the issuance costs to the equity component and all issuance costs related to the Convertible Notes are being amortized to interest expense using the effective interest method over the contractual term of the Convertible Notes which is included in the cumulative adjustment to the opening balance of accumulated deficit.

The net carrying amount of the Convertible Notes is as follows (in thousands): 

Schedule of net carrying amount of the debt component        
  October 31, 2021  April 30, 2021 
Principal $143,750  $143,750 
Unamortized debt discount (1)  0   (43,189)
Unamortized issuance costs  (4,684)  (3,612)
Net carrying amount $139,066  $96,949 

The net carrying amount of the equity component of the Convertible Notes is as follows (in thousands): 

Schedule of net carrying amount of the equity component        
  October 31, 2021  April 30, 2021 
Equity component (debt discount) $0  $44,051 
Issuance costs  0   (1,620)
Net carrying amount (1) $0  $42,431 

________________

(1)As discussed above, the adoption of ASU 2020-06 on May 1, 2021 resulted in the re-combination of the debt and equity components of the Convertible Notes into a single debt instrument. Accordingly, the unamortized debt discount balance and the net carrying amount of the equity component were derecognized.

As of October 31, 2021, the estimated fair value of the Convertible Notes was approximately $226.7 million. The fair value was determined based on the last actively traded price per $100 of the Convertible Notes for the period ended October 31, 2021 (Level 2).

The following table summarizes the interest expense recognized related to the Convertible Notes for the three and six months ended October 31, 2021 (in thousands). There were no Convertible Notes outstanding for the three and six months ended October 31, 2020. 

Schedule of Interest expense        
  

Three Months

Ended

October 31, 2021

  

Six Months

Ended

October 31, 2021

 
Contractual interest expense $449  $898 
Amortization of issuance costs  255   509 
Total interest expense $704  $1,407 

14

avid bioservices, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

Capped Call Transactions

In connection with the issuance of the Convertible Notes, we entered into privately negotiated capped call transactions (the “Capped Calls”) with certain financial institution counterparties (the “Option Counterparties”). We used $12.8 million of the net proceeds from the issuance of the Convertible Notes to pay the cost of the Capped Calls. The Capped Calls cover, subject to customary anti-dilution adjustments, the aggregate number of shares of our common stock that initially underlie the Convertible Notes, and are generally expected to reduce the potential dilution of our common stock upon any conversion of the Convertible Notes, as the case may be, with such reduction and/or offset subject to a cap, based on the cap price of the Capped Calls. The cap share price of the Capped Calls is approximately $28.02 per share, which represents a premium of 75% over the last reported sale price of our common stock on March 9, 2021 and is subject to certain adjustments under the terms of the Capped Calls. However, there would nevertheless be dilution upon conversion of the Convertible Notes to the extent that such market price exceeds the capped share price as measured under the terms of the Capped Calls.

We determined that the Capped Calls should be accounted for as a separate transaction from the Convertible Notes and that the Capped Calls met the criteria for equity classification. Therefore, the cost of $12.8 million to purchase the Capped Calls were recorded as a reduction to additional paid-in capital in the Condensed Consolidated Balance Sheet at April 30, 2021. The Capped Calls will not be subsequently remeasured as long as the conditions for equity classification continue to be met.

Note 4 – Leases

We currently lease certain office, manufacturing, laboratory and warehouse space located in southern California under operating lease agreements. Our leased facilities have original lease terms ranging from 7 to 12 years, contain multi-year renewal options, and scheduled rent increases of 3% on either an annual or biennial basis. A multi-year renewal option was included in determining the right-of-use asset and lease liability for one of our leases as we considered it reasonably certain that we would exercise such renewal option. In addition, three of our leases provide for periods of free rent, lessor improvements and/or tenant improvement allowances, of which certain of these improvements have been classified as leasehold improvements and are being amortized over the shorter of the estimated useful life of the improvements or the remaining life of the lease. The operating lease ROU assets and liabilities on our accompanying condensed consolidated balance sheets primarily relate to these facility leases.

Certain of our operating facility leases require us to pay property taxes, insurance and common area maintenance. While these payments are not included as part of our lease liabilities, they are recognized as variable lease cost in the period they are incurred.

The components of operating lease cost for the three and six months ended October 31, 2021 and 2020 were as follows (in thousands): 

Schedule of lease costs                
  

Three Months Ended

October 31,

  

Six Months Ended

October 31,

 
  2021  2020  2021  2020 
Operating lease cost $989  $788  $1,777  $1,576 
Variable lease cost  201   199   399   320 
Short-term lease cost  114   98   216   190 
Total lease cost $1,304  $1,085  $2,392  $2,086 

15

avid bioservices, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

We also lease certain manufacturing equipment under a finance lease that commenced in October 2021. We did not incur any lease costs under our finance lease for the three and six months ended October 31, 2021.

Supplemental consolidated balance sheet and other information related to our operating and finance leases as of October 31, 2021 and April 30, 2021 were as follows (in thousands, expect weighted average data): 

Balance sheet classification of leases          
Leases Classification October 31, 2021  April 30, 2021 
Assets          
Operating Operating lease right-of-use assets $38,223  $18,691 
Finance Property and equipment, net  2,760   0 
Total leased assets   $40,983  $18,691 
           
Liabilities          
Current:          
Operating Current portion of operating lease liabilities $1,378  $1,355 
Finance Other current liabilities  496   0 
Non-current:          
Operating Operating lease liabilities, less current portion  39,664   19,889 
Finance Finance lease liabilities, less current portion  2,264   0 
Total lease liabilities   $43,802  $21,244 

Weighted average remaining lease term (years):        
Operating leases  12.7   9.6 
Finance lease  5.0    
Weighted average discount rate        
Operating leases  3.4%   8.0% 
Finance lease  5.3%    

Cash paid for amounts included in the measurement of our operating lease liabilities was $1.5million for each of the six months ended October 31, 2021 and 2020, and is included in net cash used in operating activities in our accompanying unaudited condensed consolidated statements of cash flows. We did not have any cash payments associated with our finance lease liability as of October 31, 2021.

16

avid bioservices, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

As of October 31, 2021, the maturities of our lease liabilities, which includes those derived from lease renewal options that we considered it reasonably certain that we would exercise, were as follows (in thousands): 

Schedule of maturities of operating lease liabilities            
Fiscal Year Ending April 30, Operating Leases  Finance Lease  Total 
2022 (remaining period) $875  $315  $1,190 
2023  4,279   629   4,908 
2024  4,140   629   4,769 
2025  4,060   629   4,689 
2026  4,167   629   4,796 
Thereafter  32,908   314   33,222 
Total lease payments  50,429   3,145   53,574 
Less: imputed interest  (9,387)  (385)  (9,772)
Total operating lease liabilities $41,042  $2,760  $43,802 

Note 5 Stockholders’ Equity

Series E Preferred Stock

On April 12, 2021 (the “Redemption Date”), we redeemed all then current outstanding shares of our 10.50% Series E Convertible Preferred Stock (the “Series E Preferred Stock”) at a per share price equal to the $25.00 liquidation amount plus accrued and unpaid dividends up to, but excluding, the Redemption Date. In connection with the completed redemption, we incurred a charge of $3.4 million during the quarter ended April 30, 2021 related to the excess of the redemption value paid upon redemption over the carrying value of our Series E Preferred Stock. As a result of the completed redemption, our Series E Preferred Stock is no longer issued and outstanding.

Holders of our Series E Preferred Stock were entitled to receive cumulative dividends at the rate of 10.50% per annum based on the liquidation preference of $25.00 per share, or $2.625 per annum per share, and were payable quarterly in cash, on or about the first day of each January, April, July and October. For the three and six months ended October 31, 2020, we paid aggregate cash dividends of $1.1 million and $2.2 million, respectively, for issued and outstanding shares of our Series E Preferred Stock. No amounts were paid for the three and six months ended October 31, 2021.

Note 6 Equity Compensation Plans

Stock Incentive Plans

As of October 31, 2021, we had an aggregate of 9,234,968 shares of our common stock reserved for issuance under our stock incentive plans, of which 3,711,328 shares were subject to outstanding stock options, restricted stock units (“RSUs”) and performance stock units (“PSUs”) and 5,523,640 shares were available for future grants of stock-based awards.

17

avid bioservices, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

Stock Options

The following summarizes our stock option transaction activity for the six months ended October 31, 2021:

Schedule of stock option activity      
  Stock Options  Grant Date Weighted Average Exercise Price
  (in thousands)    
Outstanding at May 1, 2021 3,130  $6.56 
Granted 34  $24.08 
Exercised (289) $5.67 
Canceled or expired (158) $7.42 
Outstanding at October 31, 2021 2,717  $6.83 

Restricted Stock Units

The following summarizes our RSUs transaction activity for the six months ended October 31, 2021:

Schedule of RSU activity      
  Shares  Weighted Average Grant Date Fair Value
  (in thousands)    
Outstanding at May 1, 2021 560  $6.52 
Granted 295  $25.60 
Vested (166) $8.07 
Forfeited (45) $14.96 
Outstanding at October 31, 2021 644  $14.27 

Performance Stock Units

During the six months ended October 31, 2021, the Compensation Committee of the Board of Directors granted performance stock units (“PSUs”) to our officers. The PSUs are subject to annual vesting, as to one-third of the PSUs, over our three fiscal years ending April 30, 2022, 2023 and 2024 (each a “Performance Period”) based upon our attainment of certain predetermined financial metrics for each such Performance Period. Each PSU that vests represents the right to receive one share of our common stock. Depending on the actual financial metrics achieved relative to the target financial metrics for such Performance Periods, the number of PSUs issued could range from 0% to 200% of the target amount. The number of granted shares included in the table below is based on a maximum 200% achievement of each financial metric during each Performance Period (the “Maximum Performance Target”). In the event that a financial metric is achieved at a rate below the Maximum Performance Target, or is not achieved, the corresponding portion of the PSUs that do not vest will be forfeited.

18

avid bioservices, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

The following summarizes our PSUs transaction activity for the six months ended October 31, 2021:

Schedule of PSU activity      
  Shares  Weighted Average Grant Date Fair Value
  (in thousands)    
Outstanding at May 1, 2021 0  $ 0 
Granted 380  $25.36 
Vested 0  $ 0 
Forfeited (30) $26.03 
Outstanding at October 31, 2021 350  $25.31 

Employee Stock Purchase Plan

The Avid Bioservices, Inc. 2010 Employee Stock Purchase Plan (the “ESPP”) is a stockholder-approved plan under which employees can purchase shares of our common stock, based on a percentage of their compensation, subject to certain limits. The purchase price per share is equal to the lower of 85% of the fair market value of our common stock on the first trading day of the six-month offering period or on the last trading day of the six-month offering period. During the six months ended October 31, 2021, a total of 28,661 shares of our common stock were purchased under the ESPP at a purchase price of $10.08 per share. As of October 31, 2021, we had 1,047,665 shares of our common stock reserved for issuance under the ESPP.

Stock-Based Compensation

Stock-based compensation expense for the three and six months ended October 31, 2021 and 2020 was comprised of the following (in thousands):

Share-based compensation expense                
  

Three Months Ended

October 31,

  

Six Months Ended

October 31,

 
  2021  2020  2021  2020 
Cost of revenues $693  $372  $1,161  $649 
Selling, general and administrative  1,249   653   2,080   1,106 
Total stock-based compensation $1,942  $1,025  $3,241  $1,755 

As of October 31, 2021, the total estimated unrecognized compensation cost related to non-vested stock options and RSUs was $4.1 million and $8.6 million, respectively. These costs are expected to be recognized over weighted average vesting periods of 2.1 and 2.8 years, respectively.

As of October 31, 2021, there was $1.4 million of total estimated unrecognized compensation cost related to unvested PSUs associated with the Performance Period ending April 30, 2022. These costs are expected to be recognized over the weighted average vesting period of 0.5 years.

19

avid bioservices, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

Note 7 – Net LossIncome Per Common Share

 

Basic net lossincome per common share is computed by dividing our net lossincome attributable to common stockholders by the weighted average number of shares of common stock outstanding during the period excluding the dilutive effects of stock options, shares of common stock expected to be issued under our Employee Stock Purchase Plan (the “ESPP”), warrants, and Series E Preferred Stock outstanding during the period. Diluted net lossincome per common share is computed by dividing our net lossincome attributable to common stockholders by the sum of the weighted average number of shares of common stock outstanding during the period plus the potential dilutive effects of stock options, unvested RSUs and PSUs, shares of common stock expected to be issued under our ESPP, warrants,Convertible Notes and Series E Preferred Stock outstanding during the period.

Net lossincome attributable to common stockholders represents our net loss plusincome less Series E Preferred Stock accumulated dividends. Series E Preferred Stock accumulated dividends include dividends declared for the period (regardless of whether or not the dividends have been paid) and dividends accumulated for the period (regardless of whether or not the dividends have been declared).

 

The potential dilutive effect of stock options, unvested RSUs and PSUs, and shares of common stock expected to be issued under our ESPP and warrants outstanding during the period are calculated in accordance with the treasury stock method, but are excluded if their effect is anti-dilutive. The potential dilutive effect of our Convertible Notes and Series E Preferred Stock outstanding during the period wasare calculated using the if-converted method assuming the conversion of Convertible Notes and Series E Preferred Stock as of the earliest period reported or at the date of issuance, if later, but are excluded if their effect is anti-dilutive. However, because the impact of stock options, shares of common stock expected to be issued under our ESPP, warrants, and Series E Preferred Stock are anti-dilutive during periods of net loss, there was no difference between basic and diluted loss per common share amounts for the three and nine months ended January 31, 2018 and 2017.

The calculation of weighted average diluted shares outstanding for the three and nine months ended January 31, 2018 and 2017 excludes the dilutive effectA reconciliation of the following weighted average outstanding stock optionsnumerators and sharesthe denominators of common stock expected to be issued under our ESPP as their impact are anti-dilutive during periods of net loss:

  

Three Months Ended

January 31,

  

Nine Months Ended

January 31,

 
  2018  2017  2018  2017 
             
Stock Options  115,425      78,427    
ESPP  1,202   5,198   466   27,661 
Total  116,627   5,198   78,893   27,661 

The calculation of weighted average diluted shares outstanding for the three and nine months ended January 31, 2018 and 2017 also excludes the following weighted average outstanding stock options, warrants, shares of common stock expected to be issued under our ESPP, and Series E Preferred Stock (assuming the if-converted method), as their exercise price, purchase price and/or conversion price were greater than the average market price of our common stock during the respective periods, resulting in an anti-dilutive effect:

  

Three Months Ended

January 31,

  

Nine Months Ended

January 31,

 
  2018  2017  2018  2017 
             
Stock Options  3,214,694   4,231,073   3,663,102   4,156,497 
Warrants  39,040   39,040   39,040   39,040 
Series E Preferred Stock  1,978,783   1,978,784   1,978,783   1,948,109 
Total  5,232,517   6,248,897   5,680,925   6,143,646 

During February 2018, we sold an aggregate of 10,294,445 shares of our common stock in connection with an underwritten public offering (Note 13), which are not included in the calculation of basic and dilutive net lossincome per common share for the three and nine months ended January 31, 2018.computations are as follows (in thousands, expect per share amounts):

 

9

avid bioservices, inc.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE NINE MONTHS ENDED JANUARY 31, 2018 (unaudited) (CONTINUED)

Recently Adopted Accounting Pronouncements

Effective May 1, 2017, we adopted Accounting Standards Update (“ASU”) 2015-11, Inventory (Topic 330):Simplifying the Measurement of Inventory.  ASU 2015-11 requires that inventory should be measured at the lower of cost and net realizable value for entities that measure inventory using the first-in, first-out method. ASU 2015-11 defines net realizable value as the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal and transportation.  The adoption of ASU 2015-11 did not have a material impact on our condensed consolidated financial statements.

Effective May 1, 2017, we adopted ASU 2015-17, Income Taxes (Topic 740):Balance Sheet Classification of Deferred Taxes. Under existing standards, deferred taxes for each tax-paying jurisdiction are presented as a net current asset or liability and net long-term asset or liability. To simplify presentation, the new guidance will require that all deferred tax assets and liabilities, along with related valuation allowances, be classified as long-term on the balance sheet. As a result, each tax-paying jurisdiction will now only have one net long-term deferred tax asset or liability. The new guidance does not change the existing requirement that prohibits offsetting deferred tax liabilities from one jurisdiction against deferred tax assets of another jurisdiction. Due to the full valuation allowance on our U.S. deferred tax assets, the adoption of ASU 2015-17 did not have a material impact on our condensed consolidated financial statements.

Effective May 1, 2017, we adopted ASU 2016-09, Compensation - Stock Compensation (Topic 718):Improvements to Employee Share-Based Payment Accounting. ASU 2016-09 changes certain aspects of accounting for share-based payments to employees and involves several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. Specifically, ASU 2016-09 requires that all income tax effects of share-based awards be recognized as income tax expense or benefit in the reporting period in which they occur. Additionally, ASU 2016-09 amends existing guidance to allow forfeitures of share-based awards to be recognized as they occur. Previous guidance required that share-based compensation expense include an estimate of forfeitures. Upon adoption of ASU 2016-09, we made a policy election to recognize forfeitures as they occur. The adoption of ASU 2016-09 did not have a material impact on our condensed consolidated financial statements.

Pending Adoption of Recent Accounting Pronouncements

In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers (Topic 606):Revenue from Contracts with Customers, which, along with subsequent amendments issued in 2015 and 2016, will replace substantially all current US GAAP revenue recognition guidance. ASU 2014-09, as amended, is based on the principle that revenue is recognized to depict the transfer of goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services utilizing a new five-step revenue recognition model. The new guidance also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. ASU 2014-09, as amended, is effective for our annual reporting period beginning May 1, 2018. The new guidance permits adoption either by using (i) a full retrospective approach for all periods presented in the period of adoption or (ii) a modified retrospective approach where the new standard is applied in the financial statements starting with the year of adoption. Under both approaches, cumulative impact of the adoption is reflected as an adjustment to retained earnings (accumulated deficit) as of the earliest date presented in accordance with the new standard. We are continuing to assess the impact of the new guidance on our accounting policies and procedures and are evaluating the new requirements as applied to existing manufacturing contracts. While we continue to assess the impact of the new guidance, we believe the adoption of ASU 2014-09 will modify the way we analyze contracts. We have identified our revenue streams and based on our preliminary assessment, we believe the most significant impact may relate to the recognition of contract manufacturing revenue over a period of time rather than at a point in time. We plan to adopt ASU 2014-09, as amended, on May 1, 2018, on a modified retrospective basis.

In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). ASU 2016-2 requires an entity to recognize right-of-use assets and lease liabilities on its balance sheet and disclose key information about leasing arrangements. ASU 2016-02 offers specific accounting guidance for a lessee, a lessor and sale and leaseback transactions. Lessees and lessors are required to disclose qualitative and quantitative information about leasing arrangements to enable a user of the financial statements to assess the amount, timing and uncertainty of cash flows arising from leases. ASU 2016-02 is effective for fiscal years, and interim periods within those years, beginning after December 15, 2018, which will be our fiscal year 2020 beginning May 1, 2019. Early adoption is permitted. We are currently in the process of evaluating the impact of adoption of ASU 2016-02 on our condensed consolidated financial statements and related disclosures.

Reconciliation of earnings per share                
  

Three Months Ended

October 31,

  

Six Months Ended

October 31,

 
  2021  2020  2021  2020 
Numerator                
Net income $3,522  $2,284  $9,826  $7,014 
Series E preferred stock accumulated dividends  0   (1,442)  0   (2,523)
Net income attributable to common stockholders $3,522  $842  $9,826  $4,491 
                 
Denominator                
Weighted average common shares outstanding, basic  61,414   56,660   61,276   56,592 
Effect of dilutive securities:                
Stock options  1,882   444   1,946   349 
RSUs and PSUs  306   140   370   125 
ESPP     4   14   7 
Weighted average common shares outstanding, dilutive  63,602   57,248   63,606   57,073 
Net income per share attributable to common stockholders:                
Basic $0.06  $0.01  $0.16  $0.08 
Diluted $0.06  $0.01  $0.15  $0.08 

 

 

 

 

 1020 

 

 

avid bioservices, inc.INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE NINE MONTHS ENDED JANUARY 31, 2018 (unaudited) (CONTINUED)

In November 2016, FASB issued ASU 2016-18, Statement of Cash Flows (Topic 230):Restricted Cash, which addresses diversity in practice related to the classification and presentation of changes in restricted cash on the statement of cash flows. ASU 2016-18 will require that a statement of cash flows explain the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. Therefore, amounts generally described as restricted cash and restricted cash equivalents should be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. ASU 2016-18 is effective for fiscal years, and interim periods within those years, beginning after December 15, 2017, which will be our fiscal year 2019 beginning May 1, 2018. Early adoption is permitted. We do not expect the adoption of ASU 2016-18 to have a material impact on our condensed consolidated financial statements and related disclosures.

In May 2017, the FASB issued ASU 2017-09, Compensation - Stock Compensation (Topic 718):Scope of Modification Accounting, which provides guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718. This pronouncement is effective for annual reporting periods beginning after December 15, 2017, which will be our fiscal year 2019 beginning May 1, 2018. Early adoption is permitted. We do not expect the adoption of ASU 2016-09 to have a material impact on our condensed consolidated financial statements and related disclosures.

3.       Trade and other RECEIVABLEs

Trade receivables are recorded at the invoiced amount net of an allowance for doubtful accounts, if necessary. Other receivables are reported at amounts expected to be collected net of an allowance for doubtful accounts, if necessary. Trade and other receivables consist of the following:

  

January 31,

2018

  

April 30,

2017

 
Trade receivables(1) $7,967,000  $7,274,000 
Other receivables     468,000 
Total trade and other receivables $7,967,000  $7,742,000 

______________

(1)            Represents amounts billed for contract manufacturing services.

We continually monitor our allowance for doubtful accounts for all receivables. We apply judgment in assessing the ultimate realization of our receivables and we estimate an allowance for doubtful accounts based on various factors, such as, the aging of accounts receivable balances, historical experience, and the financial condition of our customers. Based on our analysis of our receivables as of January 31, 2018 and April 30, 2017, we determined no allowance for doubtful accounts was necessary.

4.       PROPERTY AND EQUIPMENT

Property and equipment is recorded at cost, less accumulated depreciation and amortization. Depreciation and amortization are computed using the straight-line method over the estimated useful lives of the related asset, generally ranging from three to ten years. Amortization of leasehold improvements is calculated using the straight-line method over the shorter of the estimated useful life of the asset or the remaining lease term. Construction-in-progress, which represents direct costs related to the construction of various equipment and leasehold improvements associated with our manufacturing facilities, are not depreciated until the asset is completed and placed into service. No interest was incurred or capitalized as construction-in-progress as of January 31, 2018.

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avid bioservices, inc.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE NINE MONTHS ENDED JANUARY 31, 2018 (unaudited) (CONTINUED)

Property and equipment, net, consists of the following:

  

January 31,

2018

  

April 30,

2017

 
Leasehold improvements $20,579,000  $20,098,000 
Laboratory equipment  10,683,000   10,777,000 
Furniture, fixtures, office equipment and software  4,688,000   4,499,000 
Construction-in-progress  2,558,000   2,841,000 
Total property and equipment  38,508,000   38,215,000 
Less accumulated depreciation and amortization  (12,183,000)  (11,700,000)
Total property and equipment, net $26,325,000  $26,515,000 

Depreciation and amortization expense for the three and nine months ended January 31, 2018 was $645,000 and $1,945,000, respectively. Depreciation and amortization expense for the three and nine months ended January 31, 2017 was $631,000 and $1,850,000, respectively.

5.       INVENTORIES

Inventories are recorded at the lower of cost or market (net realizable value) and primarily include raw materials, work-in-process (comprised of raw materials, direct labor and overhead costs associated with in-process manufacturing services), and finished goods (representing manufacturing services completed and ready for shipment) associated with contract manufacturing services. Overhead costs allocated to work-in-process inventory are based on the normal capacity of our production facilities and do not include costs from abnormally low production or idle capacity, which are expensed directly to cost of contract manufacturing in the period incurred. During the three and nine months ended January 31, 2018, we expensed $5,344,000 and $11,182,000, respectively, in idle capacity costs directly to cost of contract manufacturing in the accompanying condensed consolidated financial statements. No idle capacity costs were incurred during the same prior year periods. Cost is determined by the first-in, first-out method. Inventories consist of the following:

  

January 31,

2018

  

April 30,

2017

 
Raw materials $8,799,000  $11,304,000 
Work-in-process  5,419,000   13,755,000 
Finished goods     8,040,000 
Total inventories $14,218,000  $33,099,000 

6.       STOCKHOLDERS’ EQUITY

Our ability to continue to fund our operations is highly dependent on the amount of cash and cash equivalents on hand combined with our ability to raise additional capital to support our future operations through one or more methods, including but not limited to, issuing additional equity.

On January 12, 2018, we filed a universal shelf registration statement with the SEC on Form S-3, File number 333-222548 (“January 2018 Shelf”), which was declared effective by the SEC on January 25, 2018, under which we may issue, from time to time, in one or more offerings, offer and sale either individually or in combination up to $125,000,000 of our securities, including common stock, preferred stock, debt securities and warrants. As of January 31, 2018, we had not issued any of our securities under the January 2018 Shelf. Subsequent to January 31, 2018, we issued securities under the January 2018 Shelf as further discussed in Note 13, “Subsequent Events”.

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avid bioservices, inc.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE NINE MONTHS ENDED JANUARY 31, 2018 (unaudited) (CONTINUED)

Sale of Common Stock

On August 7, 2015, we entered into an At Market Issuance Sales Agreement (“AMI Sales Agreement”) with MLV & Co. LLC (“MLV”), pursuant to which we were able to sell shares of our common stock through MLV, as agent, for aggregate gross proceeds of up to $30,000,000, in registered transactions from our shelf registration statement on Form S-3 (File No. 333-201245), which was declared effective by the SEC on January 15, 2015. Sales of our common stock through MLV were made by any method that was deemed an “at the market offering” as defined in Rule 415 of the Securities Act. We paid MLV a commission equal to 2.5% of the gross proceeds from the sale of our common stock pursuant to the AMI Sales Agreement. During the quarter ended July 31, 2017, we sold 1,051,258 shares of our common stock at market prices under the AMI Sales Agreement, for aggregate gross proceeds of $4,304,000 before deducting commissions and other issuance costs of $111,000. As of July 31, 2017, we had raised the full amount of gross proceeds available to us under the AMI Sales Agreement.

Series E Preferred Stock Dividend

The following table summarizes the Series E Preferred Stock quarterly dividend activity during the nine months ended January 31, 2018:

Declaration

Date

 

Record

Date

 

Payment

Date

 

Dividends

Paid

  

Dividend

Per Share

 
6/6/2017 6/19/2017 7/3/2017 $1,081,000  $0.65625 
9/5/2017 9/18/2017 10/2/2017 $1,081,000  $0.65625 
12/7/2017 12/18/2017 1/2/2018 $1,081,000  $0.65625 
             

Shares of Common Stock Authorized and Reserved for Future Issuance

We are authorized to issue up to 500,000,000 shares of our common stock. As of January 31, 2018, 45,257,180 shares of our common stock were issued and outstanding. In addition, our common stock outstanding as of January 31, 2018 excluded the following shares of our common stock reserved for future issuance:

·5,433,646 shares of common stock reserved for issuance under outstanding option grants and available for issuance under our stock incentive plans;
·1,303,770 shares of common stock reserved for and available for issuance under our ESPP;
·39,040 shares of common stock issuable upon exercise of outstanding warrants; and
·6,826,435 shares of common stock issuable upon conversion of our outstanding Series E Preferred Stock(1).

      _____________

(1)The Series E Preferred Stock is convertible into a number of shares of our common stock determined by dividing the liquidation preference of $25.00 per share by the conversion price, currently $21.00 per share. If all of our outstanding Series E Preferred Stock were converted at the $21.00 per share conversion price, the holders of our Series E Preferred Stock would receive an aggregate of 1,961,619 shares of our common stock. However, we have reserved the maximum number of shares of our common stock that could be issued upon a change of control event assuming our shares of common stock are acquired for consideration of $5.985 per share or less. In this scenario, each outstanding share of our Series E Preferred Stock could be converted into 4.18 shares of our common stock, representing the Share Cap.

7.       equity compensation plans

Stock Incentive Plans

As of January 31, 2018, we had an aggregate of 5,433,646 shares of our common stock reserved for issuance under our stock incentive plans, of which, 3,989,356 shares were subject to outstanding options and 1,444,290 shares were available for future grants of share-based awards.

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avid bioservices, inc.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE NINE MONTHS ENDED JANUARY 31, 2018 (unaudited) (CONTINUED)

The following summarizes our stock option transaction activity for the nine months ended January 31, 2018:

Stock Options Shares  

Weighted Average

Exercisable Price

 
Outstanding, May 1, 2017  4,081,548  $8.77 
Granted  679,497  $4.17 
Exercised  (117,019)  $3.40 
Canceled or expired  (654,670)  $8.42 
Outstanding, January 31, 2018  3,989,356  $8.70 

Employee Stock Purchase Plan (ESPP)

We have reserved a total of 2,142,857 shares of our common stock to be purchased under our ESPP, of which 1,303,770 shares remained available to purchase at January 31, 2018, and are subject to adjustment as provided in the ESPP for stock splits, stock dividends, recapitalizations and other similar events. Under the ESPP, we sell shares to participants at a price equal to the lesser of 85% of the fair market value of our common stock at the (i) beginning of a six-month offering period, or (ii) end of the six-month offering period. The ESPP provides for two six-month offering periods each year; the first offering period begins on the first trading day on or after each May 1; the second offering period begins on the first trading day on or after each November 1. During the nine months ended January 31, 2018, 55,966 shares of our common stock were purchased under the ESPP at a purchase price of $3.87 per share.

Share-Based Compensation

Total share-based compensation expense related to share-based awards issued under our equity compensation plans is included in the accompanying unaudited condensed consolidated statements of operations as follows:

  

Three Months Ended

January 31,

  

Nine Months Ended

January 31,

 
  2018  2017  2018  2017 
Cost of contract manufacturing $139,000  $23,000  $277,000  $89,000 
Selling, general and administrative  259,000   389,000   589,000   1,183,000 
Discontinued operations  14,000   457,000   340,000   1,319,000 
    Total $412,000  $869,000  $1,206,000  $2,591,000 
                 
Share-based compensation from:                
Stock options $374,000  $815,000  $1,070,000  $2,369,000 
ESPP  38,000   54,000   136,000   222,000 
  $412,000  $869,000  $1,206,000  $2,591,000 

As of January 31, 2018, the total estimated unrecognized compensation cost related to non-vested employee stock options was $2,605,000. This cost is expected to be recognized over a weighted average vesting period of 2.67 years based on current assumptions.

8.       WARRANTS

No warrants were issued or exercised during the three and nine months ended January 31, 2018. As of January 31, 2018, warrants to purchase 39,040 shares of our common stock at an exercise price of $17.29 were outstanding and are exercisable through August 30, 2018.

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avid bioservices, inc.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE NINE MONTHS ENDED JANUARY 31, 2018 (unaudited) (CONTINUED)

9.       RESTRUCTURING

On August 9, 2017, our Board of Directors approved, and our management implemented, a restructuring plan intended to reduce operating costs and improve cost efficiencies while we pursued strategic options for our research and development assets and focus our efforts on growing our CDMO business. Under this restructuring plan, which we completed in October 2017, we reduced our overall workforce by 57 employees. As a result, during the quarter ended October 31, 2017, we incurred an aggregate of $1,588,000 in restructuring costs consisting of one-time termination benefits, including severance, and other employee-related costs, of which $330,000 related to our research and development segment and $1,258,000 related to our contract manufacturing services segment. The restructuring costs associated with our research and development segment are included in loss from discontinued operations in the accompanying unaudited condensed consolidated financial statements for the nine months ended January 31, 2018 (Note 10). The restructuring costs associated with our contract manufacturing services segment are included in operating expenses in the accompanying unaudited condensed consolidated financial statements for the nine months ended January 31, 2018. All restructuring costs were paid as of January 31, 2018.

10.       Sale of research and development assets

Asset Assignment and Purchase Agreement

On February 12, 2018, we entered into an Asset Assignment and Purchase Agreement (the “Purchase Agreement”) with a third-party oncology therapeutics company (the “Buyer”) pursuant to which we sold to the Buyer the majority of our research and development assets, which included the assignment of certain exclusive licenses related to our former PS-targeting program, as well as certain other licenses and assets useful and/or necessary for the potential commercialization of bavituximab. 

Pursuant to the Purchase Agreement, we expect to receive an aggregate of $8 million from the Buyer, payable in three installments over a period of approximately six and one-half months following the date of the Purchase Agreement, the first of which is due by March 14, 2018. We are also eligible to receive up to an additional $95 million in the event that the Buyer achieves certain development, regulatory and commercialization milestones with respect to bavituximab. In addition, we are eligible to receive royalties on net sales that are upward tiering into the mid-teens in the event that the Buyer commercializes and sells products utilizing bavituximab or the other transferred assets. The Buyer is responsible for all future research, development and commercialization of bavituximab, including all related intellectual property costs and all other future liabilities and obligations arising out of the ownership of the transferred assets (i.e., we remain obligated for all liabilities associated with the research and development assets associated with the Purchase Agreement incurred or arising prior to February 13, 2018). In addition, as part of the transaction, we and the Buyer agreed to diligently work in good faith to negotiate and enter into, within 90 days after the date of the Purchase Agreement, an agreement for us to provide future contract development and manufacturing activities to the Buyer in support of bavituximab.

Discontinued Operations

As a result of (i) the sale of our PS-targeting program, (ii) the held for sale classification of our R84 technology, (iii) the abandonment of our remaining research and development assets (including our intent to return the exosome technology back to the original licensor), and (iv) the strategic shift in our corporate direction to focus solely on our CDMO business that will have a major effect on our operations and financial results as we will no longer incur costs associated with research and development, the operating results from our research and development segment are reported as a loss from discontinued operations in the accompanying unaudited condensed consolidated financial statements for all periods presented (Note 1). Accordingly, the accompanying unaudited condensed consolidated financial statements for the three and nine months ended January 31, 2018 and 2017 reflect the operations of our research and development segment as a discontinued operation. The results of operations presented below include certain allocations that management believes fairly reflect the utilization of services to the research and development segment. The allocations do not include amounts related to general corporate administrative expenses or interest expense. Therefore, the results of operations from the research and development segment do not necessarily reflect what the results of operations would have been had the research and development segment operated as a stand-alone segment.

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avid bioservices, inc.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE NINE MONTHS ENDED JANUARY 31, 2018 (unaudited) (CONTINUED)

(UNAUDITED)

 

 

The following table summarizespresents the resultspotential dilutive securities excluded from the calculation of discontinued operationsdiluted net income per share for the three and nine months ended January 31, 2018 and 2017:periods presented as the effect of their inclusion would have been anti-dilutive (in thousands):

 

  

Three Months Ended

January 31,

  

Nine Months Ended

January 31,

 
  2018  2017  2018  2017 
Operating expenses:                
Research and development $374,000  $5,912,000  $7,590,000  $21,347,000 
Selling, general and administrative  1,315,000   293,000   2,097,000   1,256,000 
Restructuring charges        330,000    
                 
Total operating expenses  1,689,000   6,205,000   10,017,000   22,603,000 
                 
Other expense  387,000      387,000    
Loss from discontinued operations $2,076,000  $6,205,000  $10,404,000  $22,603,000 
Schedule of antidilutive shares                
  

Three Months Ended

October 31,

  

Six Months Ended

October 31,

 
  2021  2020  2021  2020 
Stock options  47   2,048   38   2,216 
RSUs and PSUs  247   0   157   0 
Convertible Notes  6,776   0   6,776   0 
Series E Preferred Stock  0   1,979   0   1,979 
Total  7,070   4,027   6,971   4,195 

 

We will complete the accounting for the Purchase Agreement during the fourth quarter of our current fiscal year ending April 30, 2018. In addition, we expect to use a portion of our net operating losses to offset the taxable gain from the Purchase Agreement, if any, which could result in a partial release of our valuation allowance.Note 8 – Commitments and Contingencies

 

Assets Held for Sale

The carrying value of the assets and liabilities deemed a component of the discontinued research and development segment were not classified as “assets held for sale” in the accompanying unaudited condensed consolidated balance sheets at January 31, 2018 and April 30, 2017 since there were no related assets reported as of the respective balance sheet dates and the Buyer did not assume any liabilities under the Purchase Agreement.

11.       SEGMENT REPORTING

Changes in our Organizational Structure

Historically, our business had been organized into two reportable operating segments: (i) our research and development segment, and (ii) our contract manufacturing services segment. However, as a result of the aforementioned discontinued operation (Note 10),management has determined that the Company now operates in only one operating segment. Accordingly, effective January 31, 2018, we reported our financial results for one reportable segment to reflect this new organizational structure.The accounting policies of our one reportable segment are the same as those described in Note 2.In addition, the financial results of our discontinued research and development segment are reflected as a loss from discontinued operations in the accompanying unaudited condensed consolidated financial statements for all periods presented (Note 10).

12.       commitments and contingencies

Legal ProceedingsIn the ordinary course of business, we are at times subject to various legal proceedings and disputes. We make provisions for liabilities when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated.  Such provisions, if any, are reviewed at least quarterly and adjusted to reflect the impact of any settlement negotiations, judicial and administrative rulings, advice of legal counsel, and other information and events pertaining to a particular case. We currently are not a party to any legal proceedings, the adverse outcome of which, in management’s opinion, individually or in the aggregate, would have a material adverse effect on our consolidated financial condition or results of operations.

In March 2020, the World Health Organization declared the global novel coronavirus disease (“COVID-19”) outbreak a pandemic and recommended containment and mitigation measures worldwide. Since the announcement we have been monitoring this closely, and although the COVID-19 pandemic has not had a significant impact on our operations to date, the ultimate duration and severity of the outbreak and its impact on the economic environment and our business is highly uncertain. Accordingly, we cannot provide any assurance that the COVID-19 pandemic will not have a material adverse impact on our operations or future results. The extent to which the COVID-19 pandemic may impact our future business, strategic initiatives, results of operations and financial condition will depend on future developments, which are highly uncertain and cannot be predicted, including, but not limited to the duration, spread, severity and resurgence of the COVID-19 pandemic, the effects of the COVID-19 pandemic on our customers, vendors, and employees and the remedial actions and stimulus measures adopted by local and federal governments, and the extent to which normal economic and operating conditions can resume.

 

 

 

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avid bioservices, inc.

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE NINE MONTHS ENDED JANUARY 31, 2018 (unaudited) (CONTINUED)

On October 10, 2013, a derivative and class action complaint, captionedMichaeli v. Steven W. King, et al., C.A. No. 8994-VCL, was filed in the Court of Chancery of the State of Delaware (the “Court”), purportedly on behalf of the Company, which was named a nominal defendant, against certain of our executive officers and our three former non-employee directors (collectively, the “Defendants”). On December 1, 2015, the plaintiffs filed an amended and supplemental derivative and class action complaint (the “Amended Complaint”). The Amended Complaint alleged that the Defendants breached their respective fiduciary duties in connection with certain purportedly improper compensation decisions made by our board of directors during the past four fiscal years ended April 30, 2015 and that our directors breached their fiduciary duty of candor by filing and seeking stockholder action on the basis of an allegedly materially false and misleading proxy statement for our 2013 annual meeting of stockholders. On May 15, 2017, the parties filed with the Court a Stipulation and Agreement of Compromise, Settlement and Release (the “Settlement”) setting forth the terms of the proposed settlement of the claims in the Amended Complaint. At a hearing on July 27, 2017, the Court issued an order approving the Settlement, which provided, among other things, that the three former non-employee directors agreed to pay or cause to be paid $1,500,000 to us, which amount is included as a reduction to selling, general and administrative expense in the accompanying unaudited condensed consolidated financial statements for the nine months ended January 31, 2018. We received such payment in full in August 2017.

13.       SUBSEQUENT EVENTS

Sale of Research and Development Assets

On February 12, 2018, we sold the majority of our research and development assets to a third-party oncology therapeutics company (Note 10).

Public Offering of Common Stock

On February 14, 2018, we entered into an underwriting agreement (the “Underwriting Agreement”) with Wells Fargo Securities, LLC, as representative for the underwriters identified therein (collectively, the “Underwriters”), relating to the issuance and sale in an underwritten public offering of 9,000,000 shares of our common stock, par value $0.001 per share, at a public offering price of $2.25 per share (the “Offering”). In addition, pursuant to the Underwriting Agreement, we also granted the Underwriters a 30-day option to purchase up to an additional 1,350,000 shares of our Common Stock under this Offering at the public offering price of $2.25 per share less the underwriting discounts and commissions to cover over-allotments, if any (the “Overallotment Option”).

On February 20, 2018, we completed the Offering pursuant to which we sold 10,294,445 shares of our Common Stock, including 1,294,445 shares sold pursuant to the Underwriter’s Overallotment Option at the public offering price of $2.25 per share. The aggregate gross proceeds we received from the Offering, including the shares sold pursuant to the Overallotment Option, was $23,163,000, before deducting underwriting discounts and commissions and other offering related expenses. We intend to use the net proceeds from the offering for the expansion of our contract manufacturing business and for general corporate purposes.

The Offering was made pursuant to a prospectus supplement filed with the SEC on February 14, 2018 under our January 2018 Shelf (Note 6). As of March 12, 2018, aggregate gross proceeds of up to $101,837,000 remained available to us under the January 2018 Shelf.

Series E Preferred Stock Dividend

On March 7, 2018, our Board of Directors declared a quarterly cash dividend of $0.65625 per share on our Series E Preferred Stock. The dividend payment is equivalent to an annualized 10.50% per share, based on the $25.00 per share stated liquidation preference, accruing from January 1, 2018 through March 31, 2018. The cash dividend is payable on April 2, 2018 to holders of the Series E Preferred Stock of record on March 19, 2018.

17

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

The following discussion and analysis of the financial condition and results of our operations should be read together with the financial statements and related notes of Avid Bioservices, Inc. included in Part I Item 1 of this Quarterly Report on Form 10-Q and with our audited consolidated financial statements and the related notes included in our Annual Report on Form 10-K for the fiscal year ended April 30, 2021.

Cautionary Statement Regarding Forward-Looking Statements

 

This Quarterly Report on Form 10-Q contains forward-looking statements, including the anticipated future impact of the ongoing COVID-19 global pandemic on our business operations, that involve risks and uncertainties, as well as assumptions that, if they never materialize or prove incorrect, could cause our results of operations to differ materially from those expressed or implied by such forward-looking statements. The statements contained in this Quarterly Report on Form 10-Q that are not purely historical are “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, as amended (the “Exchange Act”), which represent our projections, estimates, expectations or beliefs concerning among other things, financial items that relate to management’s future plans or objectives or to our future economic and financial performance.  In some cases, you can identify these. Forward-looking statements are often identified by terminologythe use of words such as, “may”, “should”, “plans”, “believe”, “will”, “anticipate”, “estimate”, “expect” “project”,but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would” and similar expressions or “intend”, including their opposites or similar phrases or expressions. You should be aware that thesevariations intended to identify forward-looking statements. These statements are projections or estimates asbased on the beliefs and assumptions of our management based on information currently available to future events andmanagement. These forward-looking statements are subject to a number of factors that may tend to influencenumerous risks and uncertainties, including the accuracy ofrisks and uncertainties described under the statements. These forward-looking statements should not be regarded as a representation by us or any other person that our events or plans will be achieved. You should not unduly rely on these forward-looking statements, which speak only as of the date of this Quarterly Report. We undertake no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this Quarterly Report or to reflect the occurrence of unanticipated events. You should, however, review the factors and risks we describesection titled “Risk Factors” in Part II, Section 1A of this Quarterly Report on Form 10-Q, Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended April 30, 2017,2021, those identified in this “Management’s Discussion and the reportsAnalysis of Financial Condition and Results of Operations” and elsewhere in this Quarterly Report on Form 10-Q, and in other filings we file from time to timemay make with the Securities and Exchange Commission (“SEC”) afterfrom time to time. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for our management to predict all risk factors and uncertainties, nor can we assess the dateimpact of this Quarterly Report. Actualall factors on our business or the extent to which any factor, or combination of factors, may cause actual results mayto differ materially from those contained in any forward lookingforward-looking statement. We qualify all of our forward-looking statements by these cautionary statements and, except as required by law, assume no obligation and do not intend to update these forward-looking statements.

 

Overview

 

Avid Bioservices, Inc., (“Avid”), formerly known as Peregrine Pharmaceuticals, Inc., isWe are a dedicated contract development and manufacturing organization (“CDMO”) committed to improving the lives of patients by manufacturing and delivering high quality pharmaceutical products. We providethat provides a comprehensive range of services from process development to currentCurrent Good Manufacturing Practices (“cGMP”CGMP”) clinical and commercial manufacturing, focused on development and CGMP manufacturing of biologics for the biotechnology and biopharmaceutical products derived from mammalian cell culture.industries. With 2528 years of experience producing monoclonal antibodies and recombinant proteins, in batch, fed-batch and perfusion modes, our services include cGMPCGMP clinical and commercial productdrug substance manufacturing, bulk packaging, release and stability testing and regulatory strategy, submission andsubmissions support. We also provide a variety of process development services, including cell lineupstream and downstream development and optimization, cell culture and feed optimization, analytical methods development, testing and product characterization.

Strategic Objectives

 

We have experiencea growth strategy that seeks to align with the growth of the biopharmaceutical drug substance contract services market. That strategy encompasses the following objectives:

·Invest in additional manufacturing capacity and resources required for us to achieve our long-term growth strategy and meet the growth-demand of our customers’ programs, moving from development through to commercial manufacturing;
·Broaden our market awareness through a diversified yet flexible marketing strategy;
·Continue to expand our customer base and programs with existing customers for both process development and manufacturing service offerings;
·Explore strategic opportunities both within our core business as well as in adjacent and/or synergistic service offerings in order to enhance and/or broaden our capabilities; and
·Increase our operating profit margin to best in class industry standards.

22

Second Quarter Highlights

The following summarizes select highlights from our second quarter ended October 31, 2021:

·Reported revenues of $26.1 million, an increase of 24%, or $5.0 million, compared to the same prior year period;
·Reported net income attributable to common stockholders of $3.5 million, or $0.06 per basic and diluted share;
·Continued to advance the two-phased expansion of our Myford facility as further discussed in the “Facility Expansions” section below; and
·Announced the expansion of our CDMO service offerings into the rapidly growing cell and gene therapy market, which includes plans to construct a world-class, purpose-built viral vector development and manufacturing facility as further discussed in the “Facility Expansions” section below.

Facility Expansions

During fiscal year 2021, we announced plans for a two-phased expansion of our Myford facility. The first phase, which was initiated during the second quarter of fiscal 2021, will expand the production capacity of our existing Myford North facility by adding a second downstream processing suite. This phase is mechanically complete and is expected to be online during fiscal 2022 following completion of qualification and validation. The second phase, which was initiated during the fourth quarter of fiscal 2021 and is anticipated to be online during calendar 2022, will further expand our capacity through the build out of a second manufacturing train, including both upstream and downstream processing suites, within our Myford South facility. We estimate that the total cost to complete these two phases of expansion will be approximately $70 to $75 million. Upon completion, we estimate that the first and second phases of this expansion will result in performing processa total revenue generating capacity of up to $270 million annually, depending on the mix of projects.

In October 2021, we announced plans to expand our CDMO service offerings into viral vector development and manufacturing services for the rapidly growing cell and gene therapy market. As part of biologics since 1993this expansion, we plan to construct a world-class, purpose-built viral vector development and CGMP manufacturing facility within a building we are leasing in our Franklin biomanufacturing facility, or Franklin Facility, located at our headquarters in Tustin, California. In March 2016,Costa Mesa, California (the “Viral Vector Facility”). Based on current projections, we expanded our manufacturing capacity throughexpect the launchentire build out of our new Viral Vector Facility will take up to 18 months at an estimated cost of approximately $65 million to $75 million. The Viral Vector Facility’s analytical and process development laboratories are expected to come online more rapidly, with the potential to be operational within eight months. Upon completion of the entire build out of the Viral Vector Facility, we estimate this expansion, combined with the ongoing Myford biomanufacturing facility or Myford Facility, whichexpansions, has the potential to bring our total revenue generating capacity to more than doubled our manufacturing capacity. The 42,000 square foot facility, which is our second biomanufacturing facility, includes multiple single-use bioreactors up to$350 million annually, depending on the 2,000-liter manufacturing scale. The Myford Facility was designed to accommodate a fully disposable biomanufacturing process for products in clinical development to commercial. The Myford Facility is located adjacent to our Franklin Facility.mix of projects.

Impact of COVID-19 Pandemic

 

In February 2017, we leased an additional 42,000 square feet of vacant warehouse space withinMarch 2020, the same building as our existing Myford Facility to buildWorld Health Organization declared the novel coronavirus (“COVID-19”) outbreak a third biomanufacturing facility to support future revenue growth as demand warrants. The proximity of this space will allow us to utilize existing manufacturing infrastructure that we believe should enhance our manufacturing efficiencies and reduceglobal pandemic. To date, the overall cost and timeframe to construct this third biomanufacturing facility.

In addition, we haveCOVID-19 pandemic has not had a strong regulatory track record consisting of a 15-year inspection history with no significant impact on our business. Weoperations, as we have been audited by several regulatory agencies,able to continue to operate our manufacturing facilities and provide essential services to our customers. Additionally, in an effort to protect the health and safety of our employees and in compliance with state regulations, we have instituted a work-from-home policy for employees who can perform their job functions offsite, implemented daily temperature checking, social distancing requirements and other measures to allow manufacturing and other personnel essential to production to continue work within our manufacturing facilities, and suspended all non-essential employee travel. 

The full extent to which COVID-19 will directly or indirectly impact our business, financial condition, and results of operations will depend on future developments that are highly uncertain and cannot be accurately predicted, including new information that may emerge concerning COVID-19, the U.S. Food and Drug Administration (“FDA”), the European Medicines Agency, the Brazilian Health Surveillance Agency (“ANVISA”), the Canadian Health Authorityactions taken to contain it or treat its impact and the California Departmenteconomic impact on local, regional, national and international markets. We will continue to assess the potential impact of Health. In addition, between 2005the COVID-19 pandemic on our business, financial condition, and 2017, we completed six successful pre-approval inspections. We also completed four FDA inspections between 2013results of operations. For a further discussion of potential risks to our business from the most recently completed inspectionCOVID-19 pandemic, please refer to “Part I, Item 1A—Risk Factors” in February 2018, none of which resulted in anyour Annual Report on Form 483 observations by10-K for the FDA. We have also been audited and qualified by large and small, domestic and foreign, pharmaceutical and biotechnology companies interested in the production of biologic material for clinical and commercial use.

fiscal year ended April 30, 2021.

 

 

 1823 

 


Business TransitionPerformance and Financial Measures

 

In assessing the fall of 2017, we announced our intent to cease our research and development activities and to transition our business to a dedicated CDMO. As part of our transition efforts, we have completed the following initiatives:

·In August 2017, we instituted a number of strategic actions, including the reduction of our research and development workforce, designed to reduce costs and better position ourselves to achieve overall profitability;
·In September 2017, we named Roger J. Lias, Ph.D., who has more than 20 years of management experience in the biologics CDMO industry, as the president of our contract manufacturing subsidiary. Dr. Lias was thereafter appointed our President and Chief Executive Officer in December 2017 as we transitioned to a dedicated CDMO;
·In October and November 2017, we appointed a total of six new independent members to our board of directors, each of whom has relevant CDMO industry experience;
·In November 2017, we named Tracy Kinjerski as our Vice President of Business Operations, who will focus on executing new business development initiatives with the objective of growing our commercial customer base;
·On January 5, 2018, we formally changed our corporate name to Avid Bioservices, Inc. and adopted the new ticker symbol “CDMO” on The NASDAQ Capital Market to align with the new end-market focus and strategic positioning of our business;
·By January 31, 2018, we classified our R84 technology as held for sale and we abandoned our remaining research and development assets (including our intent to return the exosome technology back to the original licensor); and
·On February 12, 2018, we sold our PS-targeting program pursuant to an Asset Assignment and Purchase Agreement (as described in Note 10 to the accompanying unaudited condensed consolidated financial statements).

Strategic Objectives

Now that we have completed the transitionperformance of our business, towe consider a dedicated CDMO, we have establishedvariety of performance and financial measures. The key indicators of the following near-term strategic objectives:

·Continue to invest in manufacturing facilities and infrastructure to maximize our facility utilization and support our customers’ clinical and commercial development and manufacturing requirements;
·Broaden our sales force by hiring sales representatives to execute our business development initiatives in key markets; and
·Expand and diversify our customer base by securing additional customers to support our future potential revenue growth beyond fiscal year 2018.

financial condition and operating performance of our business are revenues, gross profit, selling, general and administrative expenses and operating income. 

 

We intend for this discussion to provide the reader with information that will assist in understanding our consolidated financial statements, the changes in certain key items in those consolidated financial statements from period to period and the primary factors that accounted for those changes.

19

 

Revenues

Revenues are derived from services provided under our customer contracts and are disaggregated into manufacturing and process development revenue streams. The manufacturing revenue stream generally represents revenue from the manufacturing of customer products derived from mammalian cell culture covering clinical through commercial manufacturing runs. The process development revenue stream generally represents revenue from services associated with the custom development of a manufacturing process and analytical methods for a customer’s product.

Gross Profit

Gross profit is equal to revenues less cost of revenues. Cost of revenues reflects the direct cost of labor, overhead and material costs. Direct labor costs include personnel costs within the manufacturing, process and analytical development, quality assurance, quality control, validation, supply chain, project management and facilities functions. Overhead costs include the rent, common area maintenance, utilities, property taxes, security, materials and supplies, software, small equipment and deprecation costs of all manufacturing and laboratory locations. 

Selling, General and Administrative Expenses

Selling, general and administrative (“SG&A”) expenses are composed of corporate-level expenses including personnel and support costs of corporate functions such as executive management, finance and accounting, business development, legal, human resources, information technology, and other centralized services. SG&A expenses include corporate legal fees, audit and accounting fees, investor relation expenses, non-employee director fees, corporate facility related expenses, and other expenses relating to our general management, administration, and business development activities. SG&A expenses are generally not directly proportional to revenues, but we expect such expenses to increase over time to support the needs of our growing company.

 

Results of Operations

 

The following table compares the unaudited condensed consolidated statements of operations from our continuing operations for the three and ninesix months ended JanuaryOctober 31, 20182021 and 2017.2020 (in thousands): 

 

  

Three Months Ended

January 31,

  

Nine Months Ended

January 31,

 
  2018  2017  $ Change  2018  2017  $ Change 
Contract manufacturing revenue $6,819,000  $10,747,000  $(3,928,000) $46,678,000  $39,726,000  $6,952,000 
Cost of contract manufacturing  10,951,000   7,974,000   2,977,000   47,641,000   26,477,000   21,164,000 
Gross profit (loss)  (4,132,000)  2,773,000   (6,905,000)  (963,000)  13,249,000   (14,212,000)
                         
Operating expenses:                        
Selling, general & administrative  4,824,000   4,365,000   459,000   12,273,000   13,602,000   (1,329,000)
Restructuring charges           1,258,000      1,258,000 
                         
Total operating expenses  4,824,000   4,365,000   459,000   13,531,000   13,602,000   (71,000)
                         
Operating loss  (8,956,000)  (1,592,000)  (7,364,000)  (14,494,000)  (353,000)  (14,141,000)
                         
Other income (expense)                        
Interest and other income  42,000   25,000   17,000   83,000   71,000   12,000 
Interest and other expense  (14,000)  (2,000)  (12,000)  (18,000)  (2,000)  (16,000)
                         
Loss from continuing operations $(8,928,000) $(1,569,000) $(7,359,000) $(14,429,000) $(284,000) $(14,145,000)

Contract Manufacturing Revenue

Three Months:  The decrease in contract manufacturing revenue of $3,928,000 (37%) during the three months ended January 31, 2018 compared to the same period in the prior year was primarily due to a decrease in the number of manufacturing runs completed and shipped in the current year period compared to the same period in the prior year, which can primarily be attributed to a decrease in manufacturing demand from our second largest customer.

Nine Months: The increase in contract manufacturing revenue of $6,952,000 (17%) during the nine months ended January 31, 2018 compared to the same period in the prior year can primarily be attributed to revenue associated with several manufacturing runs in the aggregate amount of $9,924,000 used to support the process validation of a customer product, which product was ready for shipment in fiscal year 2017, but was deferred to fiscal year 2018 due to a shipping delay. This increase was offset partially offset by a decrease in manufacturing demand from our two largest customers. Excluding any future potential new business, we expect contract manufacturing revenue for the full fiscal year ending April 30, 2018 to decline in comparison to fiscal year 2017. Part of this decline is due to lower anticipated commitments from Halozyme, Inc., our largest customer, based on its most recent committed forecast (covering the three quarters ending September 30, 2018). As we seek to expand and diversify our customer base, we have secured five new customers since January 2017. These new customers are predominately in an earlier stage of development and, therefore, we expect that contract manufacturing revenue from these new customers during fiscal year 2018 will only partially offset the anticipated decrease in revenue from our other existing customers.

Therefore, based on our current commitments for manufacturing services and the anticipated completion of in-process manufacturing runs, we continue to expect contract manufacturing for the fiscal year ending April 30, 2018 to range from $50 to $55 million.

Gross Profit (Loss)

Three Months: During the three months ended January 31, 2018, gross margins declined to a negative 61% primarily driven by idle capacity costs in the current period, compared to gross margins of 26% for the same prior year three-month period, during which we incurred no idle capacity costs. Included within cost of contract manufacturing are idle capacity costs of $5,344,000, which negatively impacted gross margin by 78 percentage points for the three months ended January 31, 2018. This current period decline was further impacted by higher manufacturing costs associated with lower facility utilization in addition to the variability of manufacturing costs from product to product.

  

Three Months Ended

October 31,

  

Six Months Ended

October 31,

 
  2021  2020  $ Change  2021  2020  $ Change 
Revenues $26,109  $21,064  $5,045  $56,863  $46,456  $10,407 
Cost of revenues  16,923   14,646   2,277   36,286   31,494   4,792 
Gross profit  9,186   6,418   2,768   20,577   14,962   5,615 
                         
Operating expenses:                        
Selling, general and administrative  5,033   4,166   867   9,493   7,991   1,502 
Total operating expenses  5,033   4,166   867   9,493   7,991   1,502 
Operating income  4,153   2,252   1,901   11,084   6,971   4,113 
Interest income  73   32   41   149   47   102 
Interest expense  (704)     (704)  (1,407)  (4)  (1,403)
Net income $3,522  $2,284  $1,238  $9,826  $7,014  $2,812 

 

 

 2024 

 

 

Nine Months: DuringThree Months Ended October 31, 2021 Compared to Three Months Ended October 31, 2020

Revenues

Revenues for the ninethree months ended JanuaryOctober 31, 2018, gross margins declined to a negative 2%, primarily driven by idle capacity costs in the current period2021 were $26.1 million compared to 33%$21.1 million for the same period in the prior year, nine-monthan increase of $5.0 million, or 24%. The increase in revenues can primarily be attributed to fees received from a customer during the current-year period during which we incurred no idlefor unutilized reserved capacity costs. Included within cost of contract manufacturing are idle capacity costs of $11,182,000 which negatively impacted gross margin by 24 percentage pointscombined with an increase in process development revenues primarily associated with services provided to new customers. In addition, revenues for the nineprior-year period included the recognition of $1.7 million from changes in estimated variable revenue consideration as a result of completing performance obligations for certain projects, therefore increasing revenue recognized for those projects during the prior-year period. The increase in revenues was attributed to the following components of our revenue streams:

  $ millions 
Net increase in manufacturing revenues $3.6 
Net increase in process development revenues  1.4 
Total increase in revenues $5.0 

Gross Profit

Gross profit for the three months ended JanuaryOctober 31, 2018. This current2021 was $9.2 million compared to $6.4 million for the same period decline was further impactedin the prior year, an increase of approximately $2.8 million, and gross margins for such periods were 35% and 30%, respectively. The $2.8 million increase in gross profit for the current-year period can primarily be attributed to increased revenues, partially offset by higher manufacturingplanned growth costs associated with lowerpayroll and benefits, and increased facility utilization in addition toand equipment related costs. Additionally, the variabilitygross margin for the prior-year period includes the additional variable revenue consideration of manufacturing costs from product to product.$1.7 million as described above.

 

Selling, General and Administrative Expenses

 

Selling, general and administrative (“SG&A”) expenses consist primarily of payroll and related expenses and share-based compensation expense (non-cash), for personnel in executive, finance, accounting, business development, legal, human resources, information technology, and other internal support functions. In addition, SG&A expenses include corporate legal fees, auditwere $5.0 million for the three months ended October 31, 2021 compared to $4.2 million for the same period in the prior year, an increase of approximately $0.9 million, or 21%. As a percentage of revenues, SG&A expenses for the three months ended October 31, 2021 and accounting fees, investor relation expenses, non-employee director fees, facility related expenses,2020 were 19% and other expenses relating to our general management, administration, and business development activities.

Three Months:20%, respectively. The net increase in SG&A expenses of $459,000 (11%) duringwas attributed to the following components:

  $ millions 
Increase in stock-based compensation expense $0.6 
Increase in facility and related expenses  0.2 
Increase in advertising expenses  0.1 
Decrease in payroll and benefit related expenses  (0.2)
Net increase in all other SG&A expenses  0.2 
Total increase in SG&A expenses $0.9 

Operating Income

Operating income was $4.2 million for the three months ended JanuaryOctober 31, 20182021 compared to $2.3 million for the same period in the prior year period wasyear. This $1.9 million improvement in year-over-year operating income can primarily duebe attributed to a current year three-month$2.8 million increase in gross profit, partially offset by an increase in SG&A expense of approximately $0.9 million.

Interest Expense

Interest expense was $0.7 million for the three months ended October 31, 2021 compared to no interest expense for the same period increases in legal and otherthe prior year. The increase of $0.7 million can be attributed to interest expense related fees associated with a settlement agreement we entered into with certain investors during November 2018 regarding the composition ofto our board of directors and legal and advisory fees associated with the recent sale of our PS-targeting programoutstanding Convertible Notes issued in March 2021 (as described in Note 10 to the accompanying unaudited condensed consolidated financial statements).

Nine Months: The decrease in SG&A expenses of $1,329,000 (10%) during the nine months ended January 31, 2018 compared to the same prior year period was primarily due to current nine-month period decreases in payroll and related costs and non-employee director fees. The current period decrease in non-employee directors fees is attributed to the settlement terms of a derivative and class action complaint approved by the Court of Chancery3 of the State of Delaware on July 27, 2017, pursuantNotes to which our former non-employee directors agreed to pay or cause to be paid $1,500,000 to us (as described in Note 12 to the accompanying unaudited condensed consolidated financial statements), which non-recurring amount was applied against non-employee director fees during the quarter ended July 31, 2017. This decrease during the nine months ended January 31, 2018 was offset by current year period increases in facility related expenses, legal fees, investor relation fees, audit and accounting fees and other general corporate expenses.

Restructuring Charges

Restructuring charges of $1,588,000 incurred during the quarter ended October, 31, 2017 were directly related to a restructuring plan we implemented in August 2017, pursuant to which we reduced our overall workforce by 57 employees in order to reduce operating costs and improve cost efficiencies while we pursued the license or sale of our research and development assets and focus our efforts on growing our CDMO business (as described in Note 9 to the accompanying unaudited condensed consolidated financial statements)Unaudited Condensed Consolidated Financial Statements). Of the total restructuring charges incurred, $330,000 was related to our research and development segment and $1,258,000 related to our contract manufacturing services segment. The restructuring costs associated with our research and development segment are included in loss from discontinued operations in the accompanying unaudited condensed consolidated financial statements for the nine months ended January 31, 2018. The costs incurred under this restructuring plan, which was completed in October 2017, consisted of one-time termination benefits, including severance, and other employee related costs. We did not incur any restructuring charges during the three and nine months ended January 31, 2017.

Discontinued Operations

As a result of (i) the sale of our PS-targeting program (as described in Note 10 to the accompanying unaudited condensed consolidated financial statements), (ii) the held for sale classification of our R84 technology, (iii) the abandonment of our remaining research and development assets (including our intent to return the exosome technology back to the original licensor), and (iv) the strategic shift in our corporate direction to focus solely on our CDMO business that will have a major effect on our operations and financial results as we will no longer incur costs associated with research and development, the operating results from our research and development segment are reported as a loss from discontinued operations in the accompanying unaudited condensed consolidated financial statements for all periods presented.

 

 

 2125 

 

Six Months Ended October 31, 2021 Compared to Six Months Ended October 31, 2020

Revenues

Revenues for the six months ended October 31, 2021 were $56.9 million compared to $46.5 million for the same period in the prior year, an increase of $10.4 million, or 22%. The increase in revenues can primarily be attributed to an increase in fees received from customers for unutilized reserved capacity combined with a increase in process development revenues primarily associated with services provided to new customers. In addition, revenues for the prior-year period included the recognition of $1.1 million from changes in estimated variable revenue consideration as a result of completing performance obligations for certain projects, therefore increasing revenue recognized for those projects during the prior-year period. The increase in revenues was attributed to the following components of our revenue streams:

$ millions
Net increase in manufacturing revenues$5.2
Net increase in process development revenues5.2
Total increase in revenues$10.4

Gross Profit

Gross profit for the six months ended October 31, 2021 was $20.6 million compared to $15.0 million for the same period in the prior year, an increase of approximately $5.6 million, and gross margins for such periods were 36% and 32%, respectively. The $5.6 million increase in gross profit for the current-year period can primarily be attributed to increased revenues, partially offset by planned growth costs associated with payroll and benefits, and increased facility and equipment related costs. Additionally, gross margin for the prior-year period includes the additional variable revenue consideration of $1.1 million as described above.

Selling, General and Administrative Expenses

SG&A expenses were $9.5 million for the six months ended October 31, 2021 compared to $8.0 million for the same period in the prior year, an increase of approximately $1.5 million, or 19%. As a percentage of revenues, SG&A expenses for the six months ended October 31, 2021 and 2020 were both 17%. The net increase in SG&A expenses was attributed to the following components:

  $ millions 
Increase in stock-based compensation expense $1.0 
Increase in facility and related expenses  0.2 
Increase in advertising expenses  0.2 
Increase in consulting expenses  0.1 
Decrease in payroll and benefit related expenses  (0.3)
Net increase in all other SG&A expenses  0.3 
Total increase in SG&A expenses $1.5 

Operating Income

Operating income was $11.1 million for the six months ended October 31, 2021 compared to $7.0 million for the same period in the prior year. This $4.1 million improvement in year-over-year operating income can primarily be attributed to a $5.6 million increase in gross profit, partially offset by an increase in SG&A expense of approximately $1.5 million.

26

Interest Expense

Interest expense was $1.4 million for the six months ended October 31, 2021 compared to an inconsequential amount for the same period in the prior year. The increase of $1.4 million can be attributed to interest expense related to our outstanding Convertible Notes issued in March 2021 (as described in Note 3 of the Notes to Unaudited Condensed Consolidated Financial Statements).

Liquidity and Capital Resources

Our principal sources of liquidity are cash flows from operating activities as well as our cash and cash equivalents on hand.

As of October 31, 2021, we had cash and cash equivalents of $163.7 million. We believe that our existing cash on hand and our anticipated cash from operating activities will be sufficient to fund our operations for at least the next 12 months from the date of this Quarterly Report.

We currently expect to finance our operations with our existing cash on hand and our anticipated cash flows from operations. If cash flows from operations are not sufficient to support our operations or capital requirements, including our ongoing two phases of expansion to our Myford facility and the planned build out of our Viral Vector Facility, then we may need to obtain additional equity or debt financing to fund our future operations and/or such expansions. We may raise these funds at the appropriate time, accessing the form of capital that we determine is most appropriate considering the markets available to us and their respective costs of capital, such as through the issuance of debt or through the public offering of securities. These financings may not be available on acceptable terms, or at all. Our ability to raise additional capital in the equity and debt markets is dependent on a number of factors including, but not limited to, the market demand for our common stock. The market demand or liquidity of our common stock is subject to a number of risks and uncertainties including, but not limited to, our financial results, economic and market conditions, and global financial crises and economic downturns, including those caused by widespread public health crises such as the COVID-19 pandemic, which may cause extreme volatility and disruptions in capital and credit markets. In addition, even if we are able to raise additional capital, it may not be at a price or on terms that are favorable to us.

The following table presents our cash flows from operating, investing and financing activities for the six months ended October 31, 2021 and 2020 (in thousands):

  Six Months Ended October 31, 
  2021  2020 
Cash, cash equivalents and restricted cash (1) $164,025  $36,014 
Net cash provided by operating activities $3,661  $8,133 
Net cash used in investing activities $(11,824) $(2,980)
Net cash provided by (used in) financing activities $1,923  $(5,751)

_________________

(1)As of October 31, 2021 and 2020, cash, cash equivalents and restricted cash included $0.4 million that was restricted from general use, related to cash that was pledged as collateral under a letter of credit under the terms of a facility lease agreement.

Net Cash Provided By Operating Activities

During the six months ended October 31, 2021, net cash provided by operating activities decreased by $4.5 million to $3.7 million from $8.1 million of net cash provided by operating activities during the six months ended October 31, 2020.

Net cash provided by operating activities for the six months ended October 31, 2021 was a result of net income of $9.8 million combined with non-cash adjustments to net income of $5.8 million related to depreciation and amortization, stock-based compensation and amortization of debt issuance costs, offset by cash flows from the net change in operating assets and liabilities of $12.0 million.

Net cash provided by operating activities for the six months ended October 31, 2020 was a result of net income of $7.0 million combined with non-cash adjustments to net income of $3.4 million related to depreciation and amortization and stock-based compensation, offset by cash flows from the net change in operating assets and liabilities of $2.3 million.

27

Net Cash Used In Investing Activities

During the six months ended October 31, 2021, net cash used in investing activities increased by $8.8 million to $11.8 million from $3.0 million of net cash used in investing activities during the six months ended October 31, 2020.

Net cash used in investing activities for the six months ended October 31, 2021 and 2020 consisted of $11.8 million and $3.0 million, respectively, used to acquire property and equipment primarily related to our manufacturing and development operations.

Net Cash Provided By (Used In) Financing Activities

During the six months ended October 31, 2021, net cash provided by financing activities increased by $7.7 million to $1.9 million from $5.8 million of net cash used in financing activities during the six months ended October 31, 2020.

Net cash provided by financing activities for the six months ended October 31, 2021 consisted of proceeds from the issuance of common stock under our equity compensation plans of $1.9 million.

Net cash used in financing activities for the six months ended October 31, 2020 consisted primarily of $4.4 million of cash used to repay in full a promissory note issued pursuant to the Paycheck Protection Program and $2.2 million of cash used to pay preferred dividends to holders of our Series E Preferred Stock, partially offset by proceeds from the issuance of common stock under our equity compensation plans of $0.9 million.

Capital Expenditures

During the six months ended October 31, 2021, our capital expenditures were $11.8 million. We currently anticipate that our capital expenditures for the fiscal year ending April 30, 2022 will be approximately $55 to $65 million, primarily related to the expansion of our Myford facility and the planned construction of our new Viral Vector Facility as further discussed in the “Facility Expansions” section above.

Contractual Obligations

Except as set forth below, during the six months ended October 31, 2021, there were no material changes in our contractual obligations and commitments, as described in Part II, Item 7 of our Annual Report on Form 10-K for the fiscal year ended April 30, 2021.

During the six months ended October 31, 2021, we entered into and/or amended certain operating and finance leases, which leases resulted in $22.9 million of total future minimum lease payments, of which, $0.2 million is expected to be paid in fiscal 2022, $1.9 million is expected to be paid in fiscal 2023, $2.1 million is expected to be paid in fiscal 2024, $2.1 million is expected to be paid in fiscal 2025, $2.2 million is expected to be paid in fiscal 2026, and $14.4 million is expected to be paid thereafter.

 

Critical Accounting Policies and Estimates

 

Our discussion and analysis of our consolidated financial positioncondition and results of operations are based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). The preparation of our consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses, and related disclosures. We review our estimates and assumptions on an ongoing basis. We base our estimates on historical experience and on assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for our judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may vary from what we anticipate and different assumptions or estimates about the future could change our reported results. During the three and ninesix months ended JanuaryOctober 31, 2018,2021, there were no significant changes in our critical accounting policies as previously disclosed by us in Part II, Item 7 of our Annual Report on Form 10-K for the fiscal year ended April 30, 2017, other than those related to discontinued operations2021, except for our critical accounting policies and estimates on stock-based compensation associated with performance stock units granted under our equity compensation plans, as described in Note 2, “SummarySummary of Significant Accounting Policies”Policies, in the accompanying notes to the unaudited condensed consolidated financial statements.

 

Liquidity and Capital Resources

28

Recent Accounting Pronouncements

 

We have expended substantial funds on our contract manufacturing business and, historically, on the research and developmentFor a discussion of pharmaceutical product candidates. As a result, we have historically experienced losses and negative cash flows from operations since our inception and, although we have discontinued our research and development segment (as describedrecent accounting pronouncements applicable to us, please refer to Note 2, Summary of Significant Accounting Policies, in Note 1 to the accompanying notes to our unaudited condensed consolidated financial statements), we expect negative cash flows from operations to continue for the foreseeable future until we can generate sufficient revenue to achieve profitability. Therefore, unless and until we are able to generate sufficient revenue, we expect such losses to continue during the remainder of fiscal year 2018 and in the foreseeable future.statements.

Backlog

 

Our abilitybacklog represents, as of a point in time, future revenue from work not yet completed under signed contracts. As of October 31, 2021, our backlog was approximately $120 million, as compared to fund our operations is dependent onapproximately $118 million as of April 30, 2021. While we anticipate the amount of cash on hand and our ability to generate sufficient revenue to cover our operations. At January 31, 2018, we had $17,938,000 in cash and cash equivalents and in February 2018, we raised $23,163,000 in gross proceeds from the salemajority of our common stock pursuant to an underwritten public offering (as described in Note 13 to the accompanying unaudited condensed consolidated financial statements). At February 28, 2018, our cash and cash equivalents balance increased to $41,688,000.

Although it is difficult to predict all of our future liquidity requirements, we believe that our cash and cash equivalents on hand combined with the remaining projected cash receipts from manufacturing services under our current backlog and the aggregate of $8,000,000 in upfront payments we expect to receivewill be recognized as revenue over the next six (6)twelve (12) months, fromour backlog is subject to a number of risks and uncertainties, including but not limited to: the recent sale of our PS-targeting program (as described in Note 10 to the accompanying unaudited condensed consolidated financial statements) will be sufficient to fund our operations through March 2019 without securing any new business or raising any additional capital. In addition, in the eventrisk that a customer timely cancels its commitments prior to theour initiation of manufacturing services, in which case we may be required to refund some or all of the amounts paid to us in advance under those canceled commitments,commitments; the risk that a customer may experience delays in its program(s) or otherwise, which wouldcould result in the postponement of anticipated manufacturing services; the risk that we may not successfully execute on all customer projects; and the risk of a potential negative impact from the COVID-19 global pandemic, any of which could have a negative impact on our liquidity, our reported backlog and future revenue guidance. As such, we expect our current backlog (as further discussed in the “Backlog” section below) to be insufficient to cover our operating costs over the near term unless we are able to generate new business or further restructure our operations.and profitability.

 

In the event we are unable to secure sufficient business to support our operations, we may need to raise additional capital in the future. Our ability to raise additional capital in the equity markets to fund our obligations in future periods is dependent on a number of factors, including, but not limited to, the market demand for our common stock. The market demand or liquidity of our common stock is subject to a number of risks and uncertainties, including but not limited to, negative economic conditions, adverse market conditions, and adverse financial results. If we are unable to either raise sufficient capital in the equity markets or generate additional revenue, we may need to further restructure, or cease, our operations. In addition, even if we are able to raise additional capital, it may not be at a price or on terms that are favorable to us.

22

As a result, we have concluded that there is substantial doubt about our ability to continue as a going concern within one year after the date that our accompanying unaudited condensed consolidated financial statements are issued.

Significant components of the changes in cash flows from operating, investing, and financing activities for the nine months ended January 31, 2018 compared to the same prior year period are as follows:

Net Cash Used In Operating Activities. Net cash used in operating activities represents our (i) net loss, as reported, (ii) less non-cash operating expenses, and (iii) net changes in the timing of cash flows as reflected by the changes in operating assets and liabilities, as described in the below table:

  Nine Months Ended January 31, 
  2018  2017 
Net loss, as reported $(24,833,000) $(22,887,000)
Less non-cash operating expenses:        
Share-based compensation  1,206,000   2,591,000 
Depreciation and amortization  1,945,000   1,850,000 
Loss on disposal of property and equipment  401,000    
Net cash used in operating activities before changes in operating assets and liabilities $(21,281,000) $(18,446,000)
Net change in operating assets and liabilities $(6,820,000) $(9,170,000)
Net cash used in operating activities $(28,101,000) $(27,616,000)

Net cash used in operating activities increased $485,000 to $28,101,000 for the nine months ended January 31, 2018 compared to net cash used in operating activities of $27,616,000 for the nine months ended January 31, 2017. This increase in net cash used in operating activities was due to an increase of $2,835,000 in our net loss reported for the current nine-month period after deducting non-cash operating expenses as described in the above table, offset by a net change in operating assets and liabilities of $2,350,000 primarily due to the timing of cash receipts and expenditures associated with deferred revenue, customer deposits, inventories, trade and other receivables, accounts payable, and accrued clinical trial and related fees.

Net Cash Used In Investing Activities. Net cash used in investing activities for the nine months ended January 31, 2018 and 2017, was $2,144,000 and $2,439,000, respectively, which amounts primarily consisted of property and equipment acquisitions related to our manufacturing operations.

Net Cash Provided By Financing Activities. Net cash provided by financing activities for the nine months ended January 31, 2018 and 2017, was $1,384,000 and $10,171,000, respectively.

Net cash provided by financing activities during the nine months ended January 31, 2018 consisted of (i) $4,193,000 in net proceeds from the sale of shares of our common stock under an At Market Issuance Sales Agreement, (ii) $217,000 in net proceeds from the purchase of shares of our common stock under our Employee Stock Purchase Plan (“ESPP”), and (iii) $398,000 in net proceeds from stock option exercises, which amounts were offset by dividends paid on our issued and outstanding Series E Preferred Stock of $3,244,000 and principal payments on a capital lease of $180,000.

Net cash provided by financing activities during the nine months ended January 31, 2017 consisted of (i) $7,800,000 in net proceeds from the sale of shares of our common stock under an At Market Issuance Sales Agreement, (ii) $3,804,000 in net proceeds from the sale of shares of our common stock under an Equity Distribution Agreement, (iii) $1,576,000 in net proceeds from the sale of shares of our Series E Preferred Stock under a separate At Market Issuance Sales Agreement, and (iv) $254,000 in net proceeds from the purchase of shares of our common stock under our ESPP, which amounts were offset by dividends paid on our issued and outstanding Series E Preferred Stock of $3,198,000 and principal payments on a capital lease of $65,000.

Backlog

Our backlog represents, as of a point in time, future contract manufacturing revenue from work not yet completed under signed contracts. As of January 31, 2018, our backlog was approximately $39 million, the majority of which, we expect to recognize over the next twelve (12) months, compared to approximately $70 million as of January 31, 2017. In addition, in the event a customer timely cancels its commitments prior to the initiation of manufacturing services, we may be required to refund some or all of the amounts paid to us in advance under those canceled commitments, which would have a negative impact on our liquidity, our reported backlog and our future revenue.

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Item 3.Quantitative and Qualitative Disclosures About Market Risk.Risk

 

Our cash and cash equivalents are primarily invested in money market funds with one major commercial bank withDuring the primary objective to preserve our principal balance. Our deposits held with this bank exceed the amount of government insurance limits provided on our deposits and, therefore, we are exposed to credit risksix months ended October 31, 2021, there were no material changes in the eventmarket risks described in the “Quantitative and Qualitative Disclosures About Market Risk” section of default byour Annual Report on Form 10-K for the major commercial bank holding our cash balances. However, these deposits may be redeemed upon demand and, therefore, bear minimal risk. In addition, while changes in U.S. interest rates would affect the interest earned on our cash balances at January 31, 2018, such changes would not have a material adverse effect on our financial position or results of operations based on historical movements in interest rates.fiscal year ended April 30, 2021.

 

Item 4.Controls And Procedures.Procedures

Evaluation of Disclosure Controls and Procedures

 

We maintain disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e)) under the Exchange Act that are designed to ensure that information required to be disclosed in our reports filed under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

 

We carried out an evaluation, under the supervision and with the participation of management, including our Chief Executive Officerprincipal executive officer and Chief Financial Officer,principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of JanuaryOctober 31, 2018,2021, the end of the period covered by this Quarterly Report. Based on that evaluation, our Chief Executive Officerprincipal executive officer and Chief Financial Officerprincipal financial officer concluded that our disclosure controls and procedures were effective as of JanuaryOctoer 31, 2018.2021.

Changes in Internal Control over Financial Reporting

 

There were no significant changes in our internal control over financial reporting, during the quarter ended JanuaryOctober 31, 2018,2021, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

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PART II - II—OTHER INFORMATION

 

Item 1.Legal Proceedings.Proceedings

 

TheIn the ordinary course of business, we are at times subject to various legal proceedings and disputes. We make provisions for liabilities when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated.  Such provisions, if any, are reviewed at least quarterly and adjusted to reflect the impact of any settlement negotiations, judicial and administrative rulings, advice of legal counsel, and other information required by this Item is incorporated by referenceand events pertaining to Note 12, “Commitments and Contingencies,”a particular case. We currently are not a party to any legal proceedings, the adverse outcome of which, in Part I, Item 1, “Financial Information.”management’s opinion, individually or in the aggregate, would have a material adverse effect on our consolidated financial condition or results of operations.

 

Item 1A.Risk Factors.Factors

 

There have been no material changesWe operate in a rapidly changing environment that involves a number of risks that could materially and adversely affect our business, financial condition, results of operations and cash flows. For a detailed discussion of the risks that affect our business, please refer to the risk factors included in Part I, Item 1A ofIA, “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended April 30, 2017,2021. There have been no material changes to the risk factors as previously disclosed in our Annual Report on Form 10-K, except for the following risk factors:as follows:

 

If we cannot secure additional business, we may have to raise additional capital or further restructure, or cease,We are making a significant investment by expanding our operations.

We have expended substantial funds on our contract manufacturing businessCDMO service offering into the development and historically, on the research and developmentmanufacture of pharmaceutical product candidates. As a result, we have historically experienced losses and negative cash flows from operations since our inception and, although we have discontinued our research and development segment (as described in Note 1 to the accompanying unaudited condensed consolidated financial statements), we expect negative cash flows from operations to continue for the foreseeable future until we can generate sufficient revenue to achieve profitability. Therefore, unless and until we are able to generate sufficient revenue, we expect such losses to continue during the remainder of fiscal year 2018 and in the foreseeable future.

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Our ability to fund our operations is dependent on the amount of cash on hand and our ability to generate sufficient revenue to cover our operations. At January 31, 2018, we had $17,938,000 in cash and cash equivalents and in February 2018, we raised $23,163,000 in gross proceeds from the sale of our common stock pursuant to an underwritten public offering (as described in Note 13 to the accompanying unaudited condensed consolidated financial statements). At February 28, 2018, our cash and cash equivalents balance increased to $41,688,000.

Although it is difficult to predict all of our future liquidity requirements, we believe that our cash and cash equivalents on hand combined with the remaining projected cash receipts from manufacturing services under our current backlog and the aggregate of $8,000,000 in upfront payments we expect to receive over the next six (6) months from the recent sale of our PS-targeting program (as described in Note 10 to the accompanying unaudited condensed consolidated financial statements)viral vectors which will be sufficient to fund our operations through March 2019 without securing any new business or raising any additional capital. In addition, in the event a customer timely cancels its commitments prior to the initiation of manufacturing services, we may be required to refund some or all of the amounts paid tosubject us in advance under those canceled commitments, which would have a negative impact on our liquidity, our reported backlog and revenue guidance. As such, we expect our current backlog (as further discussed in the above “Backlog” section) to be insufficient to cover our operating costs over the near term unless we are able to generate new business or further restructure our operations.

In the event we are unable to secure sufficient business to support our operations, we may need to raise additional capital in the future. Our ability to raise additional capital in the equity markets to fund our obligations in future periods is dependent on a number of factors, including, but not limited to, the market demand for our common stock. The market demand or liquidity of our common stock is subject to a number of risks and uncertainties including but not limited to, negative economic conditions, adverse market conditions,that could adversely affect our operations and adverse financial results.

Our announced expansion in October 2021 of our CDMO service offering into viral vector development and manufacturing services for the cell and gene therapy market involves a number of risks that could adversely affect our operations and financial results, including the following risks:

·we may experience delays in the construction of the manufacturing facility and associated laboratories, including delays in the receipt, installation and/or validation of necessary equipment;
·we may experience significant cost overruns associated with the construction of the facility;
·our entry into a new service offering may distract our executive teams’ focus on our core mammalian cell culture operations;
·we may be unable to timely hire qualified individuals to manage and our viral vector operations; and
·we may experience delays and other challenges in engaging our initial viral vector customers due to our lack of operating experience in the viral vector market.

In addition to the foregoing, we are commencing a service offering that is currently dominated by a small number of larger organizations with established viral vector operations and significantly greater financial resources with whom we may experience difficulties in competing for talent and customers. Due to the foregoing risks and uncertainties, we cannot assure you that our viral vector development and manufacturing service offering will be successful and will not materially adversely affect our business, operating results, or financial condition. If we are unable to either raise sufficient capitalmanage these risks in the equity markets or generate additional revenue, we may need to further restructure, or cease,connection with our operations. In addition, even if we are able to raise additional capital, it may not be at a price or on terms that are favorable to us.

As a result, we have concluded that there is substantial doubt aboutbusiness expansion, our ability to continue as a going concern within one year after the date that our accompanying unaudited condensed consolidated financial statements are issued.

Ourbusiness and operating results will be adversely affected if we are unable to maximize our facility capacity utilization.

We have recently experienced idle manufacturing capacity due primarily to unexpected declines in commitments from existing customers, and we may continue to experience such idle manufacturing capacity unless commitments from these existing customers return to historical levels and/or we secure new customers. Our operating results are significantly influenced by our capacity utilization and, as such, if we are unable to utilize our facilities to capacity, our margins could be adversely affected, and our results of operations and financial condition will continue to be adversely affected. Further, while we continue to expand our manufacturing infrastructure, our revenue volume may be insufficient to ensure the economical operation of any such expanded capacity, in which case our results of operations could be adversely affected.

We have had significant losses, anticipate future losses and may never achieve profitability. 

We have incurred net losses in most fiscal years since we began operations in 1981, including net losses of $28,159,000 and $55,652,000 for the fiscal years ended April 30, 2017 and 2016, respectively. As of January 31, 2018, we had an accumulated deficit of $562,149,000. In addition, we expect negative cash flows from operations to continue for the foreseeable future until we can generate sufficient revenue to achieve profitability. Further, if we fail to generate sufficient revenue, we may never achieve profitability.materially harmed.

 

 

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We depend on spending and demand from our customers for our contract manufacturing and development services and any reduction in spending or demand could have a material adverse effect on our business.

The amount that our customers spend on the development and manufacturing of their products or product candidates, particularly the amount our customers choose to spend on outsourcing these services to us, substantially impacts our revenue and profitability. The outcomes of our customers’ research, development and marketing also significantly influence the amount that our customers choose to spend on our services and offerings. Our customers determine the amounts that they will spend on our services based upon, among other things, the clinical and market success of their products, available resources, access to capital and their need to develop new products, which, in turn, depend upon a number of other factors, including their competitors’ research, development and product initiatives and the anticipated market for any new products, as well as clinical and reimbursement scenarios for specific products and therapeutic areas. Further, increasing consolidation in the pharmaceutical industry may impact such spending, particularly in the event that any of our customers choose to develop or acquire integrated manufacturing operations. Any reduction in customer spending on biologics development and related services as a result of these and other factors could have a material adverse effect on our business, results of operations and financial condition.

The consumers of the products we manufacture for our customers may significantly influence our business, results of operations and financial condition. 

We depend on, and have no control over, consumer demand for the products we manufacture for our customers. Consumer demand for our customers’ products could be adversely affected by, among other things, delays in health regulatory approval, the inability of our customers to demonstrate the efficacy and safety of their products, the loss of patent and other intellectual property rights protection, the emergence of competing or alternative products, including generic drugs, the degree to which private and government payment subsidies for a particular product offset the cost to consumers and changes in the marketing strategies for such products. If the products we manufacture for our customers do not gain market acceptance, our revenues and profitability may be adversely affected. 

We believe that continued changes to the healthcare industry, including ongoing healthcare reform, adverse changes in government or private funding of healthcare products and services, legislation or regulations governing the privacy of patient information or patient access to care, or the delivery, pricing or reimbursement of pharmaceuticals and healthcare services or mandated benefits, may cause healthcare industry participants to purchase fewer services from us or influence the price that others are willing to pay for our services. Changes in the healthcare industry’s pricing, selling, inventory, distribution or supply policies or practices could also significantly reduce our revenue and profitability. 

If production volumes of key products that we manufacture for our customers continue to decline, results of operations and financial condition may continue to be adversely affected.

We may be unable to manage our future growth effectively, which could make it difficult to execute our business strategy. 

Earlier in fiscal year 2018, we announced our intent to transition to a dedicated contract manufacturer and, in connection with such transition, pursue strategic options to license or divest our research and development assets. As a result of this transition, during the quarter ended October 31, 2017, we reduced our overall workforce as part of a series of strategic actions to reduce costs and better position us to achieve potential profitability. Now that we have completed our transition to a dedicated contract manufacturer, we intend to grow our business operations as demand increases and increase the number of our employees to accommodate such potential growth, which may cause us to experience periods of rapid growth and expansion. This potential future growth could create a strain on our organizational, administrative and operational infrastructure, including manufacturing operations, quality control, technical support and other administrative functions. Our ability to manage our growth properly will require us to continue to improve our operational, financial and management controls. 

As our commercial operations and sales volume grow, we will need to continue to increase our capacity for manufacturing, customer service, billing and general process improvements and expand our internal quality assurance program, among other things. We may also need to purchase additional equipment, some of which can take several months or more to procure, set up and validate, and increase our manufacturing, maintenance, software and computing capacity to meet increased demand. These increases in scale, expansion of personnel, purchase of equipment or process enhancements may not be successfully implemented.  

26

If we are unable to protect the confidentiality of our customers’ proprietary information, we may be subject to claims.

Many of the formulations used and processes developed by us in manufacturing our customers’ products are subject to trade secret protection, patents or other intellectual property protections owned or licensed by such customer. While we make significant efforts to protect our customers’ proprietary and confidential information, including requiring our employees to enter into agreements protecting such information, if any of our employees breaches the non-disclosure provisions in such agreements, or if our customers make claims that their proprietary information has been disclosed, our reputation may suffer damage and we may become subject to legal proceedings that could require us to incur significant expenses and divert our management’s time, attention and resources. 

Our services and our customers’ products may infringe on or misappropriate the intellectual property rights of third parties.

Any claims that our services infringe the rights of third parties, including claims arising from any of our customer engagements, regardless of their merit or resolution, could be costly and may divert the efforts and attention of our management and technical personnel. We may not prevail in such proceedings given the complex technical issues and inherent uncertainties in intellectual property litigation. If such proceedings result in an adverse outcome, we could be required, among other things, to pay substantial damages, discontinue the use of the infringing technology, expend significant resources to develop non-infringing technology, license such technology from the third party claiming infringement (which license may not be available on commercially reasonable terms or at all) and/or cease the manufacture, use or sale of the infringing processes or offerings, any of which could have a material adverse effect on our business. 

In addition, our customers’ products may be subject to claims of intellectual property infringement and such claims could materially affect our business if their products cease to be manufactured and they have to discontinue the use of the infringing technology which we may provide. Any of the foregoing could affect our ability to compete or could have a material adverse effect on our business, financial condition and results of operations. 

If we do not enhance our existing or introduce new service offerings in a timely manner, our offerings may become obsolete or uncompetitive over time, customers may not buy our offerings and our revenue and profitability may decline. 

Demand for our manufacturing services may change in ways that we may not anticipate due to evolving industry standards and customer needs that are increasingly sophisticated and varied, as well as the introduction by others of new offerings and technologies that provide alternatives to our offerings. In the event we are unable to offer or enhance our service offerings or expand our manufacturing infrastructure to accommodate requests from our customers and potential customers, our offerings may become obsolete or uncompetitive over time, in which case our revenue and operating results would suffer. For example, if we are unable to respond to changes in the nature or extent of the technological or other needs of our customers through enhancing our offerings, our competition may develop offerings that are more competitive than ours and we could find it more difficult to renew or expand existing agreements or obtain new agreements. Potential innovations intended to facilitate enhanced or new offerings generally will require a substantial capital investment before we can determine their commercial viability, and we may not have financial resources sufficient to fund all desired innovations. Even if we succeed in creating enhanced or new offerings, however, they may still fail to result in commercially successful offerings or may not produce revenue in excess of our costs of development, and they may be rendered obsolete by changing customer preferences or the introduction by our competitors of offerings embodying new technologies or features. Finally, the marketplace may not accept our innovations due to, among other things, existing patterns of clinical practice, the need for regulatory clearance and/or uncertainty over market access or government or third-party reimbursement.

We operate in a highly competitive market and competition may adversely affect our business. 

We operate in a market that is highly competitive. Our competition in the contract manufacturing market includes full-service contract manufacturers and large pharmaceutical companies offering third-party manufacturing services to fill their excess capacity. We may also compete with the internal operations of those pharmaceutical companies that choose to source their product offerings internally. Additionally, several large pharmaceutical companies have recently sought to divest portions of their manufacturing capacity, and any such divested businesses may compete with us in the future. In addition, most of our competitors may have substantially greater financial, marketing, technical or other resources than we do. Moreover, additional competition may emerge, particularly in lower-cost jurisdictions such as India and China, which could, among other things, result in a decrease in the fees paid for our services, which may adversely affect our results of operations and financial condition.  

27

We rely on third parties to supply most of the necessary raw materials and supplies for the products we manufacture on behalf of our customers and our inability to obtain such raw materials or supplies may adversely impact our business, results of operations and financial condition. 

Our operations require various raw materials, including proprietary media, resins, buffers, filters, in addition to numerous additional raw materials supplied primarily by third parties. We or our customers specify the raw materials and other items required to manufacture their product and, in some cases, specify the suppliers from whom we must purchase these raw materials. In certain instances, the raw materials and other items can only be supplied by a limited number of suppliers or in limited quantities. If third-party suppliers do not supply raw materials or other items on a timely basis, it may cause a manufacturing run to be delayed or canceled which would adversely impact our results of operations and financial condition. 

Furthermore, third-party suppliers may fail to provide us with raw materials and other items that meet the qualifications and specifications required by us or our customers. If third-party suppliers are not able to provide us with raw materials that meet our or our customers’ specifications on a timely basis, we may be unable to manufacture their product or it could prevent us from delivering products to our customers within required timeframes. Any such delay in delivering our products may create liability for us to our customers for breach of contract or cause us to experience order cancellations and loss of customers. In the event that we manufacture products with inferior quality components and raw materials, we may become subject to product liability claims caused by defective raw materials or components from a third-party supplier or from a customer, or our customer may be required to recall its products from the market. 

If we use hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages. 

Our contract manufacturing operations involve, and our prior activities with respect to our recently sold research and development assets involved, the controlled use of hazardous materials and chemicals. We are subject to federal, state and local laws and regulations in the U.S. governing the use, manufacture, storage, handling and disposal of hazardous materials and chemicals. Although we believe that our procedures for using, handling, storing and disposing of these materials comply with legally prescribed standards, we may incur significant additional costs to comply with applicable laws in the future. Also, even if we are in compliance with applicable laws, we cannot completely eliminate the risk of contamination or injury resulting from hazardous materials or chemicals. As a result of any such contamination or injury, we may incur liability or local, city, state or federal authorities may curtail the use of these materials and interrupt our business operations. In the event of an accident, we could be held liable for damages or penalized with fines, and the liability could exceed our resources. Compliance with applicable environmental laws and regulations is expensive, and current or future environmental regulations may impair our contract manufacturing operations, which could materially harm our business, financial condition and results of operations.  

We are subject to product liability claims. 

Our contract manufacturing services expose us to an inherent risk of liability, as the antibodies or other substances we manufacture, at the request and to the specifications of our customers, could possibly cause adverse effects or have product defects. We obtain agreements from our customers indemnifying and defending us from any potential liability arising from such risk. However, these indemnification agreements may not adequately protect us against potential claims relating to such contract manufacturing services or protect us from being named in a possible lawsuit. Although we have procured insurance coverage, we may not be able to maintain our existing coverage or obtain additional coverage on commercially reasonable terms, or at all, or such insurance may not provide adequate coverage against all potential claims to which we might be exposed. Additionally, any lawsuits in which we may be named could be costly to defend and could result in significant liabilities, adverse publicity and diversion of our management’s time, attention and resources. A partially successful or completely uninsured claim against us could materially harm our business, financial condition and results of operations.

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If we lose qualified management, including manufacturing or scientific personnel or are unable to attract and retain such personnel, we may be unable to successfully manufacture our customers’ products.

Our success is dependent, in part, upon a limited number of key executive officers, each of whom is an at-will employee. For example, because of his extensive understanding of our contract manufacturing operations and technologies, the loss of Roger J. Lias, Ph.D, our President and Chief Executive Officer, would adversely affect our contract manufacturing operations during the six- to twelve-month period that we estimate it would take to find a qualified replacement. 

We also believe that our future success will depend largely upon our ability to attract and retain highly-skilled manufacturing and process development personnel. We face intense competition in our recruiting activities, including competition from larger companies with greater resources. The loss of certain key employees or our inability to attract and retain other qualified employees could negatively affect our operations and financial performance. 

U.S. federal income tax reform could adversely affect us and our stockholders. 

The Tax Cuts and Jobs Act, or TCJA, significantly reforms the Internal Revenue Code of 1986, as amended, or the Code. The TCJA, among other things, includes changes to U.S. federal tax rates, imposes significant additional limitations on the deductibility of interest, allows for the expensing of capital expenditures, effectuates the migration from a “worldwide” system of taxation to a territorial system and modifies or repeals many business deductions and credits. We continue to examine the impact the TCJA may have on our business. While we continue to evaluate the effect of the TCJA on our business, including our projection of minimal cash taxes and our net operating losses, the impact of such tax reform on holders of our common stock is uncertain and may be adverse.   

We may face additional liabilities associated with our prior research and development activities. 

We recently sold the majority of our research and development assets, including our development-stage immunotherapy product, bavituximab. As a result, we are no longer pursuing our prior research and development activities, including the clinical development associated therewith. We may still face unknown liabilities associated with these prior activities. For example, in the course of our prior development of our product candidate, bavituximab, we contracted with third parties to conduct a series of clinical trials and although we maintain product liability insurance for clinical studies in the amount of $10,000,000 per occurrence or $10,000,000 in the aggregate on a claims-made basis, as well as country-specific coverage where required for clinical sites located in foreign countries, our coverage may not be adequate in the event we face a product liability claim due to an adverse effect resulting from any of such trials. Any liabilities arising from our prior research and development activities that are not covered by our insurance coverage could negatively impact our financial position and results of operations. 

We may be subject to various litigation claims and legal proceedings. 

We, as well as certain of our directors and officers, may be subject to claims or lawsuits during the ordinary course of business. Regardless of the outcome, these lawsuits may result in significant legal fees and expenses and could divert management’s time and other resources. If the claims contained in these lawsuits are successfully asserted against us, we could be liable for damages and be required to alter or cease certain of our business practices. Any of these outcomes could cause our business, financial performance and cash position to be negatively impacted.

A significant number of shares of our common stock are issuable pursuant to outstanding options and convertible securities, and we may issue additional shares of common stock in the future. Sales or conversions of these shares will dilute the interests of other security holders and may depress the price of our common stock. 

As of January 31, 2018, 5,433,646 shares of common stock reserved for issuance under outstanding option grants and available for issuance under our stock incentive plans and outstanding warrants to purchase up to 39,040 shares of common stock. Additionally, as of January 31, 2018, there were 1,303,770 shares of common stock reserved for and available for issuance under our ESPP and up to 6,826,435 shares of common stock issuable upon conversion of our outstanding Series E Preferred Stock. The issuance of additional shares of common stock upon the exercise or conversion, as applicable, of any of the foregoing securities, or the perception that such issuances may occur, would have a dilutive impact on other stockholders and could have a material negative effect on the market price of our common stock.

29

Our highly volatile stock price may adversely affect the liquidity of our common stock. 

The market price of our common stock has generally been highly volatile and is likely to continue to be highly volatile. For instance, the market price of our common stock has ranged from $1.97 to $14.00 per share over the last three fiscal years ended April 30, 2017 (as adjusted to reflect the 1-for-7 reverse stock split of our issued and outstanding common stock that took effect on July 10, 2017).

In addition, the market price of our common stock may be significantly impacted by many factors, including, but not limited to: 

·our loss of a significant customer;
·uncertainties about our ability to continue to fund our operations beyond the next twelve months;
·significant changes in our financial results or that of our competitors, including our ability to continue as a going concern;
·our ability to meet revenue projections;
·the offering and sale of shares of our common stock, either sold at market prices or at a discount under an equity transaction;
·significant changes in our capital structure;
·published reports by securities analysts;
·announcements of partnering transactions, licensing agreements, joint ventures, strategic alliances, and any other transaction that involves the development, sale or use of our technologies or competitive technologies;
·regulatory developments, including possible delays, and product safety concerns;
·outcomes of significant litigation, disputes and other legal or regulatory proceedings;
·general stock trends in the biotechnology and pharmaceutical industry sectors;
·public concerns as to the safety and effectiveness of the products we manufacture;
·economic trends and other external factors, including but not limited to, interest rate fluctuations, economic recession, inflation, foreign market trends, national crisis, and disasters; and
·healthcare reimbursement reform and cost-containment measures implemented by government agencies.

These and other external factors have caused and may continue to cause the market price and demand for our common stock to fluctuate substantially, which may limit or prevent investors from readily selling their shares of common stock, and may otherwise negatively affect the liquidity of our common stock.

Item 2.Unregistered Sales of Equity 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



 30 

 

 

Item 6.Exhibits

(a)Exhibits:

10.1First Amendment to the Avid Bioservices, Inc. 2018 Omnibus Incentive Plan.Exhibits. *

 

(a)Exhibits:

3.1Certificate of Incorporation of Avid Bioservices, Inc., a Delaware corporation, as amended through January 5, 2018. *
4.1Form of Indenture (Incorporated by reference to Exhibit 4.4 to the Registrant’s Registration Statement on Form S-3 filed with the SEC on January 12, 2018). **
10.1Settlement Agreement, dated November 27, 2017, by and among Avid Bioservices, Inc., Ronin Trading, LLC, Ronin Capital, LLC, SWIM Partners LP, SW Investment Management LLC, John S. Stafford, III, Stephen White and Roger Farley (Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on November 28, 2017). **
10.2Severance Agreement and Mutual General Release between Steven W. King and Avid Bioservices, Inc. dated December 22, 2017. *
31.1Certification of Chief Executive Officer pursuant to Rule 13a-14(a)/ and 15d-14(a) of the Securities Exchange Act of 1934, as amended.*

31.2Certification of Chief Financial Officer pursuant to Rule 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as amended.*

31.2Certification of Chief Financial Officer pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934, as amended. *
32Certification of Chief Executive Officer and Chief Financial Officer pursuant to Rule 13a-14(b)/15d-14(b)18 U.S.C. 1350, as adopted pursuant to Section 906 of the Securities ExchangeSarbanes-Oxley Act of 1934, as amended, and 18 U.S.C. Section 1350.2002.*

101.INSInline XBRL Taxonomy Extension Instance Document. Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document).*

101.SCHInline XBRL Taxonomy Extension Schema Document.*

101.CALInline XBRL Taxonomy Extension Calculation Linkbase Document.*

101.DEFInline XBRL Taxonomy Extension Definition Linkbase Document.*

101.LABInline XBRL Taxonomy Extension Label Linkbase Document. *
101.PREXBRL Presentation Extension Linkbase Document. *

__________

101.PREInline XBRL Taxonomy Extension Presentation Linkbase Document.*Filed herewith.

104Cover Page Interactive Data File (formatted in iXBRL, and included in exhibit 101).**Previously filed.

  

_______________________

* Filed herewith.

† Management contract or a compensation plan or arrangement.

 

 

 31 

 

SIGNATURES

 

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

 

 AVID BIOSERVICES, INC.
  
Date:March 12, 2018By:
Date:  December 7, 2021/s/ Roger J. Lias, Ph.D.By: /s/ Nicholas S. Green
 Nicholas S. Green
 Roger J. Lias, Ph.D.
President and Chief Executive Officer
 (Principal Executive Officer)
  
  
Date:March 12, 2018December 7, 2021    By:/s/ Paul J. Lytle /s/ Daniel R. Hart
 Daniel R. Hart
 

Paul J. Lytle
Chief Financial Officer

(signed both as an officer duly authorized to sign on behalf of the Registrant and principal financial officerPrincipal Financial Officer and chief accounting officer)

Principal Accounting Officer)

 

 

 

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