Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

________________________

FORM 10-K

(Mark One)

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

For the fiscal year ended April 30, 20192020

or

oTRANSITION 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)

Delaware95-3698422
(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)
2642 Michelle Drive, Suite 200, Tustin, California92780
(Address of principal executive offices)(Zip Code)
(714) 508-6100
(Registrant’s telephone number, including area code)

Delaware95-3698422

(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)

2642 Michelle Drive, Suite 200, Tustin, California92780

(Address of principal executive offices)(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
Preferred Stock Purchase Rights
10.50% Series E Convertible Preferred Stock, $0.001 par value per shareCDMOPCDMOPThe NASDAQ Stock Market LLC

Securities registered pursuant to Section 12(g) of the Act:  None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.    Yeso   Nox

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Securities Act. YesoNox

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.   YesxNoo

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted 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).   YesxNoo

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” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated fileroAccelerated filero
Non-accelerated filerx
Smaller reporting companyx
Emerging growth companyo

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 has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.x

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

The aggregate market value of the shares of common stock held by non-affiliates of the registrant as of October 31, 2018,2019, the last business day of the registrant’s most recently completed second fiscal quarter, was approximately $293,016,000,$300,503,000, calculated based on the closing price of the registrant’s common stock as reported by The NASDAQ Capital Market.

As of June 14, 2019,19, 2020, the number of shares of registrant’s common stock outstanding was 56,137,724.56,511,294.

DOCUMENTS INCORPORATED BY REFERENCE

Part III of this report incorporates certain information by reference from the registrant’s proxy statement for the annual meeting of stockholders, which proxy statement will be filed no later than 120 days after the close of the registrant’s fiscal year to which this report relates.

 

 

 

   

 

 

AVID BIOSERVICES, INC.

Form 10-K

For the Fiscal Year Ended April 30, 20192020

 

TABLE OF CONTENTS

 

PART I 
Item 1.Business42
Item 1A.Risk Factors107
Item 1B.Unresolved Staff Comments2117
Item 2.Properties2117
Item 3.Legal Proceedings2117
Item 4.Mine Safety Disclosures2117
PART II 
Item 5.Market For Registrant’s Common Equity, Related Stockholder Matters And Issuer Purchases Of Equity Securities2218
Item 6.Selected Financial Data2420
Item 7.Management’s Discussion And Analysis Of Financial Condition And Results Of Operations2521
Item 7A.Quantitative And Qualitative Disclosures About Market Risk3430
Item 8.Financial Statements And Supplementary Data3430
Item 9.Changes In And Disagreements With Accountants On Accounting And Financial Disclosures6260
Item 9A.Controls And Procedures6260
Item 9B.Other Information6361
PART III 
Item 10.Directors, Executive Officers And Corporate Governance6562
Item 11.Executive Compensation6562
Item 12.Security Ownership Of Certain Beneficial Owners And Management And Related Stockholder Matters6562
Item 13.Certain Relationships And Related Transactions, And Director Independence6663
Item 14.Principal Accounting Fees and Services6663
PART IV 
Item 15.Exhibits And Financial Statement Schedules6764
Item 16.Form 10-K Summary6764
  
SIGNATURES7067

 

 

 

 2i 

 

 

Cautionary Note on Forward-Looking Statements

 

In this Annual Report on Form 10-K (the “Annual Report”), unless the context otherwise indicates, the terms “we,” “us,” “our,” “Company” and “Avid” refer to Avid Bioservices, Inc. and its consolidated subsidiaries. In addition to historical information, this Annual Report contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that involve risks and uncertainties. The inclusion of forward-looking statements should not be regarded as a representation by us or any other person that the objectives or plans will be achieved because our actual results may differ materially from any forward-looking statement. The words “may,” “should,” “plans,” “believe,” “anticipate,” “estimate,” “expect,” their opposites and similar expressions are intended to identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. We caution readers that such statements are not guarantees of future performance or events and are subject to a number of factors that may tend to influence the accuracy of the statements including, but not limited to, those risk factors outlined in the section titled, “Risk Factors”Factors,” as well as those discussed elsewhere in this Annual Report. You should not dulyunduly rely on these forward-looking statements, which speak only as of the date of this Annual Report. We undertake no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this Annual Report or to reflect the occurrence of unanticipated events. You should, however, review the factors and risks we describe in the reports that we file from time to time with the Securities and Exchange Commission (“SEC”) after the date of this Annual Report.

 

Avid Bioservices® is a registered trademark of Avid Bioservices, Inc. All other brand names or trademarks appearing in this Annual Report are the property of their respective holders.

 

 

 

 

 

 

 

 

 

 

 

 

 

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PART I

Item 1.Business

 

Overview

 

We are a dedicated contract development and manufacturing organization (“CDMO”) that provides a comprehensive range of services from process development to Current Good Manufacturing Practices (“CGMP”) clinical and commercial manufacturing, focused on biopharmaceutical productsdrug substances derived from mammalian cell culture. With over 2527 years of experience producing monoclonal antibodies and recombinant proteins, in batch, fed-batch and perfusion modes, our services include CGMP clinical and commercial productdrug substance manufacturing, purification, bulk packaging, release and stability testing and regulatory submissions and support. We also provide a variety of process development services, including cell lineupstream and downstream development and optimization, cell cultureanalytical method development, testing and feed optimization, analytical methods development and product characterization.

We have experience in performing process All our services are available as either stand-alone or bundled for full development and manufacturing of biologics since 1993 in our Franklin biomanufacturing facility (“Franklin Facility”) located at our headquarters in Tustin, California. In March 2016, we expanded our manufacturing capacity through the commissioning of one-half of our 84,000 square foot Myford biomanufacturing facility (“Myford Facility”), our second biomanufacturing facility, which includes multiple single-use bioreactors up to 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.programs.

 

Business Transition in Fiscal 2018

 

During the fourth quarter of fiscal year 2018, we announced our intent to cease our research and development activities and to transitiontransitioned our business to a dedicated CDMO which we completed during the fourth quarter of fiscal year 2018.and ceased our research and development activities. As part of our transition, efforts during fiscal year 2018, we instituted a number of strategic actions designed to reduce costs and better position ourselves as a dedicated CDMO, including the following:we: (i) we amended our Certificate of Incorporation to change our corporate name to Avid Bioservices, Inc., effective January 5, 2018, and we adopted the new“CDMO” as our ticker symbol “CDMO” on The NASDAQ Capital Market to align with the new end-market focusMarket; (ii) sold our phosphatidylserine (“PS”)-targeting and strategic positioning of our business; (ii) we classified our r84 technology as held for sale, which we subsequently soldtechnologies in fiscal year2018 and 2019, pursuant to anrespectively, under two separate Asset Assignment and Purchase AgreementAgreements (as described in Note 1011 of the Notes to the accompanying consolidated financial statements)Consolidated Financial Statements) and abandoned our remaining research and development assets; (iii) we sold our phosphatidylserine (PS)-targeting program pursuant to an Asset Assignment and Purchase Agreement (as described in Note 10 to the accompanying consolidated financial statements); and (iv) we(iii) closed an underwritten public offering of our common stock pursuant to which we sold 10,294,445 shares of our common stock at an offering price of $2.25 per sharein February 2018 for aggregate grossnet proceeds of $23.2 million before deducting underwriting discounts, commissions and other offering related expenses of $1.7$21.5 million.

 

Business Strategy

 

FollowingWe have a growth strategy that seeks to align with the completiongrowth of our business transition to a dedicated CDMO, we established and began executing onthe biopharmaceutical drug substance contract services market. That strategy encompasses the following near-term strategic objectives:

 

·Expand existing customer relationshipsInvest in additional manufacturing capacity and diversifyresources required for us to achieve our customer base by securing additional customerslong-term growth strategy and meet the growth-demand of our customers’ programs, moving from development through to supportcommercial manufacturing;
·Broaden our potential future revenue growth beyond fiscal year 2019.market awareness through a diversified yet flexible marketing strategy;

·Continue to invest in manufacturing facilitiesexpand our customer base and infrastructure to maximize our facility utilization and support our customers’programs with existing customers for both process development and clinicalmanufacturing service offerings; and commercial manufacturing requirements.

·Broaden our sales force by hiring sales representativesIncrease operating profit margin to execute our business development initiativesbest in key markets.class industry standards.

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Our Competitive Strengths

 

We believe that we are well positioned to address the market for outsourced development and manufacturing of biopharmaceuticals derived from mammalian cell culture, due to the following factors:

 

·Expertise in Mammalian Cell Culture Manufacturing: We believe that continued consolidation in the CDMO industry over the past several years has resulted in a limited number of nimble,qualified, agile and independent CDMOs with mammalian cell culture-based biologics development and manufacturing capabilities. The mammalian cell culture production method is highly suitable for manufacturing complex molecules (examples include monoclonal antibodies, next-generation antibodies and recombinant proteins), and we believe the benefits of the mammalian cell culture production method have played a significant role in accelerating the proliferation of biologics therapies. We believe we are well positioned in the industry, given our expertise in mammalian cell culture for biologics manufacturing.

 

2

·Broad Spectrum of Services to Support Customers from Early Stage Development to Commercial: We provide fully integrated and customized biomanufacturing services that support our clientscustomers from the early preclinical stage to commercial launch and supply. We believe pharmaceutical companies generally prefer to engage with CDMOs that are able to work with a product throughout its lifecycle and have long-standing track records of regulatory compliance and quality control. Our Process Development, CGMP Drug Substance Biomanufacturing, Project Management, Quality Systems and Quality Control are all supported by modern facilities designed to meet customer needs from early stage development to commercial supply. We differentiate our capabilities through several key criteria: (i) we employ a customer-centric approach and collaborate with our clientscustomers to tailor customized development and manufacturing services; (ii) our agile manufacturing and development capabilities allow for rapid responses to shifting production requirements, leading to strong clientcustomer satisfaction and retention; and (iii) our single-use bioreactors contributescontribute to enhanced manufacturing efficiency for our customers and reduces our capital spending needs.

 

·Strong Regulatory Track Record: Historically, developing the expertise to comply with stringent regulatory audits and validation requirements has been a challenge for both pharmaceutical companies and CDMOs, and has been seen as a significant barrier to entry for many CDMOs, as facilities can take years to construct and properly validate. We believe pharmaceutical companies place a premium on working with CDMOs that can ensure a high degree of regulatory compliance, which decreases execution risk. We have a strong regulatory track record, consisting of a 16-year17-year inspection history with no significant impact on our business. In addition, betweensince 2005 and 2017, we completed six successful pre-approval inspections. We also completed four U.S. Food and Drug Administration (“FDA”) inspections between 2013 and the most recently completed inspection in early calendar year 2018, none of which resulted in any Form 483 observations by the FDA. Further, we haveroutinely successfully compliedcomply with audits fromby large pharmaceutical companies.

 

·Modern and Optimized Infrastructure: As a result ofWith the development of our Myford Facility and the recent commissioning of our new process development laboratory space in late calendar year 2019, we believe we have positioned our business to capitalize on increasing demand in the biologics manufacturing industry for modular cleanroom space, onsite process development laboratory and single-use bioreactors. These developments have driven demand among pharmaceutical companies for facilities that can match bioreactor sizedevelop and produce pilot scale batches (up to smaller volume production runs.200 liters) in process development using a process train that matches the single-use bioreactors in CGMP production. With single-use bioreactors ranging from 200 to 2,000 liters, our CGMP Myford Facility is designed to provide our customers with the desired efficiency and flexibility.

 

·Significant Manufacturing Experience with a Proven Track Record: We have 2627 years of experience producing monoclonal antibodies and recombinant proteins, over 1415 years of CGMP commercial manufacturing experience and over 1112 years of experience with single-use bioreactor technology. OurWe believe this experience, combined with our management team and board of directors have adirectors’ deep understanding ofexperience in the CDMO industry, and have contributed their collective expertisepositions us to our recent transition to a dedicated CDMO.take advantage of positive long term industry trends.

5

 

Our Growth Strategy

 

We believe we have a significant opportunity to drive organic growth by leveraging our strengths, broadening our capabilities, increasing our capacity and improving our market visibility. Further, our transition to a dedicated CDMO has allowed us to re-allocate resources previously utilized for our research and development activities and focus on the growth of our CDMO business.

 

·Diversify Customer Base.: We have taken and continue to take steps to diversify and expand our customer base and have developed marketing and sales strategies designed to drive new clientcustomer acquisitions, while also continuing to leverage our existing relationships to pursue additional collaborationssupport new programs with our existing customers.

 

·Expand Process Development Capabilities. We also continue to expand: Most recently, we expanded our process development capabilities in order to make our operations more attractive to emerging, mid-sized and large pharmaceutical companies. We are currently in the process of expanding and optimizing our process development capabilities and laboratory space, which includes expandingThis expansion included increasing our total available process development and laboratory space, to more than 6,000 square feet, upgrading theupgraded infrastructure and equipment within our existing process development laboratories, and implementingimplemented new state-of-the-art technologies and equipment (including benchtop bioreactors and pilot scale manufacturing up to 200 liters) designed to facilitate efficient, high-throughput development of innovative upstream and downstream manufacturing processes. We are strategically conducting this work in phases to avoid disruption to current customer programs.processes that transfer directly into our CGMP manufacturing facility. 

3

 

·Expand Manufacturing Footprint and Enhance Efficiencies. We lease an additional: Our existing Myford Facility has 42,000 square feet of vacant warehouse space, within the same building as our existing Myford Facility, which will allow us to utilize existing manufacturing and quality infrastructure that we believe should enhance our manufacturing efficiencies and reduce the overall cost and timeframe to construct a third biomanufacturing facility. This space could house a facility that can accommodate up to six additional 2,000-liter single-use bioreactors. However,As we currently do not expectcontinue to commence constructionfill capacity in our current CGMP facilities, we will refine our plans and determine the appropriate time to execute this expansion that will more than double our installed liters of the new facility until the manufacturing capacity at our existing facilities is close to full utilization or we determine that we require additional capacity to meet specific customer demand.capacity.

 

·Increase Operating Margins.: We believe we have the opportunity to drive operating margin expansion by increasing manufacturing throughput, fillingutilizing our available capacity, and implementing continuous process efficiencies and continued process improvements.efficiencies. We believe increased facility capacity utilization resulting from the growth strategies described herein, will permit us to generate more favorabledrive significantly improved operating margins. We expect to improve operating margins through investment in our facilities, people, process and technology.

 

·Reinvest in Equipment and Facilities.: We believe that re-investing in our laboratory and manufacturing equipment and facilities is strategically important to meet future customer demand.

 

Our Facilities

 

Our 12,000 square-foot Franklin Facility includes stainless steel bioreactors (100-liter to 1,000-liter) and single-use bioreactors (200-liter to 1,000-liter), water-for-injection, an autoclave and depyrogenation oven, material storage (including a walk-in cold room) and cell bank cryofreezers. The Franklin Facility is located at our headquarters in Tustin, California.

Our 42,000 square-foot Myford Facility ishas 42,000 square feet of space designed to utilize single-use equipment up to the 2,000-liter manufacturing scale to accommodate a fully disposable biomanufacturing process for products from clinical development to commercial supply. Our Myford Facility includes single-use bioreactors (200-liter to 2,000-liter), quality control labs for environmental and analytical testing, warehousing and material storage (including two walk-in cold rooms) and cell bank cryofreezers. The Myford Facility is located adjacent to our Franklin Facility and has an additional 42,000 square-feet of space available for future expansion.

 

Our 12,000 square-foot Franklin Facility includes stainless steel bioreactors (100-liter to 1,000-liter) and single-use bioreactors (200-liter to 1,000-liter), water-for-injection, an autoclave and depyrogenation oven, material storage (including a walk-in cold room) and cell bank cryofreezers. The Franklin Facility is located adjacent to our headquarters in Tustin, California.

 

6

Manufacturing and Raw Materials

 

We manufacture CGMP pharmaceutical-grade products for our customers. The process for manufacturing generally uses commercially available raw materials from multiple suppliers, and in some instances, from a single source supplier. See “Risk Factors—Risks Related to Our Business—Business” for additional discussion of raw materials supplied by third party vendors for the products we manufacture for our customers. 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, financial condition, and results of operations and financial condition” for additional discussion of raw materials supplied by third party vendors for the products we manufacture for our customers.operations.

 

Regulatory Matters

 

We have a strong and proven regulatory track record, including 1617 years of inspection history with no significant impact to our business. To date, we have been successfully audited and qualified by large and small and domestic and foreign biotechnology companies interested in the production of biologic material for clinical and commercial use. Additionally, we have been successfully audited by several regulatory agencies, including the FDA, the European Medicines Agency (“EMA”), the Brazilian Health Surveillance Agency (“ANVISA”), the Canadian Health Authority (“Health Canada”), the California Department of Health and the Australian Department of Health.

 

We are required to comply with the regulatory requirements of various local, state, national and international regulatory bodies having jurisdiction in the countries or localities where we manufacture products or where our customers’ products are distributed. In particular, we are subject to laws and regulations concerning research and development, testing, manufacturing processes, equipment and facilities, including compliance with CGMPs, labeling and distribution, import and export, and product registration and listing. As a result, our facilities are subject to regulation by the FDA, as well as regulatory bodies of other jurisdictions such aswhere our customers have marketing approval for their products including, but not limited to, the EMA, ANVISA, Health Canada, and the Australian Department of Health. We are also required to comply with environmental, health and safety laws and regulations, as discussed in “Environmental and Safety Matters” below. These regulatory requirements impact many aspects of our operations, including manufacturing, developing, labeling, packaging, storage, distribution, import and export and record keeping related to customers'customers’ products. Noncompliance with any applicable regulatory requirements can result in government refusal to approve facilities for manufacturing products or products for commercialization.

4

 

Our customers’ products must undergo pre-clinical and clinical evaluations relating to product safety and efficacy before they are approved as commercial therapeutic products. The regulatory authorities having jurisdiction in the countries in which our customers intend to market their products may delay or put on hold clinical trials, delay approval of a product or determine that the product is not approvable. The FDA or other regulatory agencies can delay approval of a drug if our manufacturing facilities are not able to demonstrate compliance with CGMPs, pass other aspects of pre-approval inspections (i.e., compliance with filed submissions) or properly scale up to produce commercial supplies. The FDA and comparable government authorities having jurisdiction in the countries in which our customers intend to market their products have the authority to withdraw product approval or suspend manufacture if there are significant problems with raw materials or supplies, quality control and assurance or the product is deemed adulterated or misbranded. If new legislation or regulations are enacted or existing legislation or regulations are amended or are interpreted or enforced differently, we may be required to obtain additional approvals or operate according to different manufacturing or operating standards or pay additional fees. This may require a change in our manufacturing techniques or additional capital investments in our facilities.

 

The costs associated with complying with the various applicable local, state, national and international regulations could be significant and the failure to comply with such legal requirements could have an adverse effect on our financial condition and results of operations and financial condition.operations. See “Risk Factors—Risks Related to Our Business—Business” for additional discussion of the costs associated with complying with the various regulations. Failure to comply with existing and future regulatory requirements could adversely affect our business, financial condition and results of operations and financial condition” for additional discussion of the costs associated with complying with the various regulations.operations.

 

7

Environmental and Safety Matters

 

Certain products manufactured by us involve the use, storage and transportation of toxic and hazardous materials. Our operations are subject to extensive laws and regulations relating to the storage, handling, emission, transportation and discharge of materials into the environment and the maintenance of safe working conditions. We maintain environmental and industrial safety and health compliance programs and training at our facilities.

 

Prevailing legislation tends to hold companies primarily responsible for the proper disposal of their waste even after transfer to third party waste disposal facilities. Other future developments, such as increasingly strict environmental, health and safety laws and regulations, and enforcement policies, could result in substantial costs and liabilities to us and could subject the handling, manufacture, use, reuse or disposal of substances or pollutants at our facilities to more rigorous scrutiny than at present.

 

Intellectual Property

 

We do not currently own any patents and do not have any patent applications pending in the United States or any foreign countries. However, we have acquired and developed and continue to acquire and develop knowledge and expertise (“know-how”) and trade secrets in the provision of process development and manufacturing services. Our know-how and trade secrets may not be patentable, but they are valuable in that they enhance our ability to provide high-quality services to our customers. We typically place restrictions in our agreements with third-parties, which contractually restrict their right to use and disclose any of our proprietary technology with which they may be involved. In addition, we have internal non-disclosure safeguards, including confidentiality agreements, with our employees.

 

We also own trademarks to protect the names of our services. Trademark protection continues in some countries soas long as the trademark is used, and in other countries, soas long as the trademark is registered. Trademark registration is for fixed terms and can be renewed indefinitely.

 

Segment Information

 

Our business had historically beenis organized into twoone reportable operating segments: (i)segment, our contract manufacturing services segment and (ii) our former research and development segment. However, as a result of the aforementioned strategic shift in our corporate direction to focus solely on our CDMO business, which resulted in the discontinuation of our research and development segment (as described in Note 10 to the accompanying consolidated financial statements), management has determined that we operate in oneoperating segment with one reporting segment. Accordingly, the operating results of our former research and development segment and the related assets and liabilities have been presented as discontinued operations in the accompanying consolidated financial statements for all periods presented. In addition, we had no foreign-based operations and no long-lived assets located in foreign countries as of and for the fiscal years ended April 30, 2020, 2019 2018 and 2017.2018.

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Customers

 

Revenues have historically been derived from a small customer base. For the fiscal years ended April 30, 2020, 2019 2018 and 2017,2018, we derived approximately 64%63%, 86%64% and 98%86% of our revenues from theour top three customers, respectively. While we have been able to expand and diversify our customer base since we became a dedicated CDMO in January 2018, weWe continue to be dependent on a limited number of customers for a substantial majority of our revenue. In addition, the duration of our fulfillment of customer contracts varies from a few months to more than 24 months, due to the nature and size of each customer’s requirements. The loss of, or a significant reduction of business from, any of our primary customers could have a material adverse effect on our business, financial condition and results of operations and financial condition.operations. Refer to Note 2, “Summary of Significant Accounting Policies” of the Notes to the accompanying consolidated financial statementsConsolidated Financial Statements for additional financial information regarding our customer concentration, including the name of significant customers, and geographic location of customers.

 

8

Backlog

 

Our backlog represents, as of a point in time, future contract manufacturing revenue from work not yet completed under signed contracts. As of April 30, 2019,2020, our backlog was approximately $46$65 million, as compared to approximately $48$46 million as of April 30, 2018.2019. While we anticipate the majority of our backlog will be recognized during fiscal year 2020,2021, our backlog is subject to a number of risks and uncertainties, including the risk that a customer timely cancels its commitments prior to our 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; the risk that a customer may experience delays in its program(s) or otherwise, which could result in the postponement of anticipated manufacturing services; and the risk that we may not successfully execute on all customer projects, any of which could have a negative impact on our liquidity, reported backlog and future revenue.

 

Competition

 

Our competition in the CDMO market includes a number of full-service contract manufacturers and large pharmaceutical companies offering third-party manufacturing services to fill their excess capacity. Also, large pharmaceutical companies have been seeking to divest portions of their manufacturing capacity, and any such divested businesses may compete with us in the future. Some of our significantly larger and global competitors have substantially greater financial, marketing, technical or other resources than we do. Moreover, additional competition may emerge and may, among other things, result in a decrease in the fees paid for our services,create downward pricing pressure, which would affect our financial condition and results of operations and financial condition.operations.

 

Employees

 

As of April 30, 2019,2020, we employed 211222 full-time employees and 45 part-time employees. None of our employees are covered by a collective bargaining agreement. We have not experienced employment-related work stoppages and consider our employee relations to be good.

 

Company Information

 

We were originally incorporated in the State of California in June 1981 and reincorporated in the State of Delaware on September 25, 1996. Our principal executive offices are located at 2642 Michelle Drive, Suite 200, Tustin, California, 92780 and our telephone number is (714) 508-6100. Our principal website address iswww.avidbio.com. The information on, or that can be accessed through, our website is not part of this Annual Report.

 

Available Information

 

This Annual Report, our Quarterly Reports on Form 10-Q, our Current Reports on Form 8-K, and our proxy statements, and all amendments to those reports filed with or furnished to the SEC are available, free of charge, through the SEC’s website atwww.sec.gov and our website atwww.avidbio.com as soon as reasonably practicable after such reports are electronically filed with or furnished to the SEC. The information on, or that can be accessed through, our website is not part of this Annual Report.

 

 

 

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Item 1A.Risk Factors

You should carefully consider the risks and uncertainties described below, together with all of the other information contained in this report, including our consolidated financial statements and the related notes thereto, before making a decision to invest in our securities. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties not presently known to us, or that we currently believe are not material, also may become important factors that affect us and impair our business operations. The occurrence of any of the events or developments discussed in the risk factors below could have a material and adverse impact on our business, financial condition, results of operations financial condition and cash flows and, in such case, our future prospects would likely be materially and adversely affected.

Risks Related to Our Business

 

If we cannot secure additional business, we may have to raise additional capital or further restructure, or cease, our operations.

 

We have expended substantial funds on our contract manufacturing business and, historically, on our research and development business, which we discontinued in fiscal year 2018. As a result, we have historically experienced losses and negative cash flows from operations since our inception and expectmay continue to experience negative cash flows from operations to continue until we can generate sufficient revenue to generate positive cash flow from operations.

Our ability to fund our operations is dependent on the amount of cash on hand and our ability to generate positive cash flow to sustain our current operations. At April 30, 2019,2020, we had $32.4$36.3 million in cash and cash equivalents. Although it is difficult to forecast all of our future liquidity requirements, we believe that our cash and cash equivalents on hand, combined with our projected cash receipts from services generatedto be rendered under our existing customer contracts, will be sufficient to fund our operations beyond one year after the date our consolidated financial statements are issued without securing any additional manufacturing services projects, capital equipment financing, or raising additional capital in the equity markets.

In addition, in the event a customer timely cancels its commitments prior to our initiation of manufacturing services, we may be required to refund some or all of the advance payments made to us under those canceled commitments, which would have a negative impact on our liquidity, reported backlog and future revenue.

In Further, in the event we are unable to secure sufficient business to support our current operations, we may need to raise additional capitalin the future.equity markets in order to fund our future operations. We may raise funds through the issuance of debt or through the public offering of securities. There can be no assurance that equity financingthese financings will be available to us on acceptable terms, or at all. Our ability to raise additional capital in the equity and debt markets to fund our future operations 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 and economic and market conditions. Further, global financial crises and economic downturns, including those caused by widespread public health crises such as the global novel coronavirus disease, may cause extreme volatility and disruptions in capital and credit markets, and may impact our ability to raise additional capital when needed on acceptable terms, if at all. If we are unable to fund our continuing operations through these sources, 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. Any of these actions could materially harm our business, financial condition, results of operations, and future prospects.

 

Our business, financial condition, and results of operations may be adversely affected by global health epidemics, including the COVID-19 pandemic.

In March 2020, the World Health Organization declared the global novel coronavirus disease (“COVID-19”) outbreak a pandemic. COVID-19 has spread across the globe and is affecting worldwide economic activity. Any public health epidemic, including the COVID-19 pandemic, may affect our operations and those of third parties on which we rely, including our customers and suppliers. Our business, financial condition, and results of operations may be affected by: disruptions in our customers’ abilities to fund, develop, or bring to market products as anticipated; delays in or disruptions to the conduct of clinical trials by our customers; cancellations of contracts or confirmed orders from our customers; and the inability, difficulty, or additional cost or delays in obtaining key raw materials, components, and other supplies from our existing supply chain; among other factors caused by the COVID-19 pandemic. Our operations could be disrupted if some of our employees become ill or are otherwise absent from work as a result of the COVID-19 pandemic. Additionally, governmental restrictions, including travel restrictions, quarantines, shelter-in-place orders, business closures, new safety requirements or regulations, or restrictions on the import or export of certain materials, or other operational issues related to the COVID-19 pandemic may have an adverse effect on our business and results of operations. We continue to monitor our operations and governmental recommendations and have made modifications for an indefinite period to our normal operations because of the COVID-19 pandemic, including requiring most non-production related employees to work remotely which may increase cyber security risks or create data accessibility concerns.

7

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

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 financial condition and results of operations and financial condition will continue to be adversely affected. We have experienced idle manufacturing capacity due primarily to declines in commitments from certain of our existing customers, and we may continue to experience such idle manufacturing capacity until we secure substantial additional revenues from existing and/or new customers.

 

10

We have a history of 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 $4.2$10.5 million and $21.8$4.2 million for the fiscal years ended April 30, 20192020 and 2018,2019, respectively. As of April 30, 2019,2020, we had an accumulated deficit of $560.6$571.1 million. We expectmay continue to experience negative cash flows from operations to continue until we can generate sufficient additional revenue from operations to achieve profitability and positive cash flows. If we fail to generate sufficient additional revenue, we may never achieve profitability.

 

Because a significant portion of our revenue comes from a limited number of customers, any decrease in sales to these customers could harm our business, financial condition, and results of operations and financial condition.operations.

Revenue has historically been derived from a small customer base. For the fiscal years ended April 30, 2020, 2019 2018 and 2017,2018, we derived approximately 64%63%, 86%64% and 98%86% of our revenuerevenues from theour top three customers, respectively. While we have been able to expand and diversify our customer base since we became a dedicated CDMO in January 2018, weWe continue to be dependent on a limited number of customers for a substantial majority of our revenue. The loss of, or a significant reduction of business from, any of our major customers could have a material adverse effect on our business, financial condition, and results of operations and financial condition.operations.

 

Failure to comply with existing and future regulatory requirements could adversely affect our business, financial condition, and results of operations and financial condition.operations.

Our industry is highly regulated. We are required to comply with the regulatory requirements of various local, state, provincial, national and international regulatory bodies having jurisdiction in the countries or localities in which we manufacture products or in which our customers’ products are distributed. In particular, we are subject to laws and regulations concerning development, testing, manufacturing processes, equipment and facilities, including compliance with CGMPs, import and export, and product registration and listing, among other things. As a result, most of our facilities are subject to regulation by the FDA, as well as regulatory bodies of other jurisdictions such aswhere our customers have marketing approval for their products including, but not limited to, the EMA, ANVISA and/or Health Canada, depending on the countries in which our customers market and sell the products we manufacture on their behalf. As we expand our operations and geographic scope, we may be exposed to more complex and new regulatory and administrative requirements and legal risks, any of which may require expertise in which we have little or no experience. It is possible that compliance with new regulatory requirements could impose significant compliance costs on us. Such costs could have a material adverse effect on our business, financial condition and results of operations.

 

These regulatory requirements impact many aspects of our operations, including manufacturing, developing, storage, distribution, import and export and record keeping related to customers’ products. Noncompliance with any applicable regulatory requirements can result in government refusal to approveapprove: (i) facilities for testing or manufacturing products or (ii) products for commercialization. The FDA and other regulatory agencies can delay, limit or deny approval for many reasons, including:

 

·changes to the regulatory approval process, including new data requirements for product candidates in those jurisdictions, including the United States, in which our customers may be seeking approval;
·that a customer’s product candidate may not be deemed to be safe or effective;
·the ability of the regulatory agency to provide timely responses as a result of its resource constraints; and
·that the manufacturing processes or facilities may not meet the applicable requirements.

 

 

 

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In addition, if new legislation or regulations are enacted or existing legislation or regulations are amended or are interpreted or enforced differently, we may be required to obtain additional approvals or operate according to different manufacturing or operating standards. This may require a change in our development and manufacturing techniques or additional capital investments in our facilities. Any related costs may be significant. If we fail to comply with applicable regulatory requirements in the future, then we may be subject to warning letters and/or civil or criminal penalties and fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, restrictions on the import and export of our products, debarment, exclusion, disgorgement of profits, operating restrictions and criminal prosecution and the loss of contracts and resulting revenue losses. Inspections by regulatory authorities that identify any deficiencies could result in remedial actions, production stoppages or facility closure, which would disrupt the manufacturing process and supply of product to our customers. In addition, such failure to comply could expose us to contractual and product liability claims, including claims by customers for reimbursement for lost or damaged active pharmaceutical ingredients or recall or other corrective actions, the cost of which could be significant.

 

In addition, certain products we manufacture must undergo pre-clinical and clinical evaluations relating to product safety and efficacy before they are approved as commercial therapeutic products. The regulatory authorities having jurisdiction in the countries in which we or our customers intend to market their products may delay or put on hold clinical trials or delay approval of a product or determine that the product is not approvable. The FDA or other regulatory agencies can delay approval of a drug if our manufacturing facility, including any newly commissioned facility, is not able to demonstrate compliance with CGMPs, pass other aspects of pre-approval inspections or properly scale up to produce commercial supplies. The FDA and comparable government authorities having jurisdiction in the countries in which we or our customers intend to market their products have the authority to withdraw product approval or suspend manufacture if there are significant problems with raw materials or supplies, quality control and assurance or the product we manufacture is adulterated or misbranded. If our manufacturing facilities and services are not in compliance with FDA and comparable government authorities, we may be unable to obtain or maintain the necessary approvals to continue manufacturing products for our customers, which would materially adversely affect our financial condition and results of operations and financial condition.operations.

 

Our customer’s failure to receive or maintain regulatory approval for their product candidates could negatively impact our revenue and profitability.

Our contract manufacturing business materially depends upon the regulatory approval of the products we manufacture. As such, if our customers experience a delay in, or failure to receive, approval for any of their product candidates or fail to maintain regulatory approval of their products, our revenue and profitability could be adversely affected. Additionally, if the FDA or a comparable foreign regulatory authority does not approve of our facilities for the manufacture of a customer product or if it withdraws such approval in the future, our customers may choose to identify alternative manufacturing facilities and/or relationships, which could significantly impact our ability to expand our CDMO capacity and capabilities and achieve profitability.

Our manufacturing services are highly complex, and if we are unable to provide quality and timely services to our customers, our business could suffer.

The manufacturing services we offer are highly complex, due in part to strict regulatory requirements. A failure of our quality control systems in our facilities could cause problems to arise in connection with facility operations for a variety of reasons, including equipment malfunction, viral contamination, failure to follow specific manufacturing instructions, protocols and standard operating procedures, problems with raw materials or environmental factors. Such problems could affect production of a single manufacturing run or a series of runs, requiring the destruction of products, or could halt manufacturing operations altogether. In addition, our failure to meet required quality standards may result in our failure to timely deliver products to our customers which, in turn, could damage our reputation for quality and service. Any such incident could, among other things, lead to increased costs, lost revenue, reimbursement to customers for lost drug substance, damage to and possibly termination of existing customer relationships, time and expense spent investigating the cause and, depending on the cause, similar losses with respect to other manufacturing runs. With respect to our commercial manufacturing, if problems are not discovered before the product is released to the market, we may be subject to regulatory actions, including product recalls, product seizures, injunctions to halt manufacture and distribution, restrictions on our operations, civil sanctions, including monetary sanctions, and criminal actions. In addition, such issues could subject us to litigation, the cost of which could be significant.

 

 

 

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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 manufacture 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, financial condition, and results of operations and financial condition.operations.  

 

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

 

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, our financial condition and 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.

During fiscal year 2018 we completed our transition to a dedicated CDMO and, in connection with the transition, we divested our research and development assets and reduced our overall workforce to reduce costs and better position us to achieve potential profitability. We intend to continue to grow our business operations as demand for our services 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.

13

 

As we expect our commercial operations and sales volume to 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, install and validate, and increase our manufacturing, maintenance, software and computing capacity to meet increased demand. We may not be able to successfully implement the increase in scale, expansion of personnel, purchase and validation of equipment or process enhancements, which could adversely affect our ability to increase revenues.

10

 

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 the manufacture of 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 expense 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 uncompetitivenoncompetitive over time, customers may not buy our offerings and our revenues 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 uncompetitivenoncompetitive 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.

 

14

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. 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 financial condition and results of operations and financial condition.operations.  

 

11

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, financial condition, and results of operations and financial condition.operations. 

Our operations require various raw materials, including proprietary media, resins, buffers, and 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 and, in some cases, a single source, 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 financial condition and results of operations and financial condition.operations.  Additionally, we do not have long-term supply contracts with any of our single source suppliers. If we experience difficulties acquiring sufficient quantities of required materials or products from our existing suppliers, or if our suppliers are found to be non-compliant with the FDA’s quality system regulation, CGMPs or other applicable laws or regulations, we would be required to find alternative suppliers. If our primary suppliers become unable or unwilling to perform, any resulting delays or interruptions in the supply of raw materials required to support our manufacturing of CGMP pharmaceutical-grade products would ultimately delay our manufacture of products for our customers, which could materially and adversely affect our financial condition and operating results and financial condition.results.

 

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 recently discontinued research and development activities 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.

15

Potential product liability claims, errors and omissions claims in connection with services we perform and potential liability under indemnification agreements between us and our officers and directors could adversely affect us.

 

We manufacture products intended for use in humans. These activities could expose us to risk of liability for personal injury or death to persons using such products. We seek to reduce our potential liability through measures such as contractual indemnification provisions with customers (the scope of which may vary by customer, and the performances of which are not secured) and insurance maintained by us and our customers. We could be materially adversely affected if we are required to pay damages or incur defense costs in connection with a claim that is outside the scope of the indemnification agreements, if the indemnity, although applicable, is not performed in accordance with its terms or if our liabilities exceed the amount of applicable insurance or indemnity. In addition, we could be held liable for errors and omissions in connection with the services we perform. We currently maintain product liability and errors and omissions insurance with respect to these risks. There can be no assurance, however, that our insurance coverage will be adequate or that insurance coverage will continue to be available on terms acceptable to us.

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We also indemnify our officers and directors for certain events or occurrences while the officer or director is serving at our request in such capacity. The maximum potential amount of future payments we could be required to make under these indemnification agreements is unlimited. Although we have a director and officer insurance policy that covers a portion of any potential exposure, we could be materially and adversely affected if we are required to pay damages or incur legal costs in connection with a claim above such insurance limits.

 

Any claims beyond our insurance coverage limits, or that are otherwise not covered by our insurance, may result in substantial costs and a reduction in our available capital resources.

 

We maintain property insurance, employer’s liability insurance, product liability insurance, general liability insurance, business interruption insurance, and directors’ and officers’ liability insurance, among others. Although we maintain what we believe to be adequate insurance coverage, potential claims may exceed the amount of insurance coverage or may be excluded under the terms of the policy, which could cause an adverse effect on our business, financial condition and results from operations. Generally, we would be at risk for the loss of inventory that is not within customer specifications. These amounts could be significant. In addition, in the future we may not be able to obtain adequate insurance coverage or we may be required to pay higher premiums and accept higher deductibles in order to secure adequate insurance coverage.

 

We depend on key personnel and the loss of key personnel could harm our business and results of operations.

 

We depend on our ability to attract and retain qualified scientific and technical employees, as well as a number of key executives. These employees may voluntarily terminate their employment with us at any time. There can be no assurance that we will be able to retain key personnel, or to attract and retain additional qualified employees. We do not maintain key-man or similar policies covering any of our senior management or key personnel. Our inability to attract and retain key personnel would have a material adverse effect on our business.

 

We have federal and state net operating loss (“NOL”) carry forwards which, if we were to become profitable, could be used to offset/defer federal and state income taxes. Our ability to use such carry forwards to offset future taxable income may be subject to certain limitations related to changes in ownership of our stock.

As of April 30, 2019,2020, we had federal and state NOL carry forwards of approximately $426$427 million and $274$277 million, respectively, expiring from 20202021 to 2038. These NOL carry forwards could potentially be used to offset certain future federal and state income tax liabilities. However, utilization of NOL carry forwards may be subject to a substantial annual limitation pursuant to Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”), as well as similar state provisions due to ownership changes that have occurred previously or that could occur in the future. In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of certain stockholders or public groups in the stock of a corporation by more than 50 percentage points over a three-year period. A Section 382 analysis was completed as of the fiscal year ended April 30, 20182019 and we subsequently reviewed such activity through April 30, 2019,2020, which we determined that no such change in ownership has occurred. However, ownership changes occurring subsequent to April 30, 20192020 may impact the utilization of our NOL carry forwards and other tax attributes. Any limitation may result in expiration of a portion of the carry forwards before utilization. If we were not able to utilize our carry forwards, we would be required to use our cash resources to pay taxes that would otherwise have been offset, thereby reducing our liquidity.

 

16

U.S. federal income tax reform could adversely affect us.

In December 2017, the Tax Cuts and Jobs Act (the “Tax Act”) was signed into law, significantly reforming theInternal Revenue Code of 1986, as amended (the “Code”).Code. The Tax Act, 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. While we have completed the accounting for the income tax effects of the Tax Act on our financial statements as of April 30, 2019, weWe continue to examine the impact the Tax Act may have on our business. As the overall impact of the Tax Act is evolving, we continue to evaluate the effect of the Tax Act on our business, including our projection of minimal cash taxes and our net operating losses, the impact of such tax reform could have a negative impact on our financial results and the market price of our common stock.

 

13

Business disruptions could seriously harm our future revenues and financial condition and increase our costs and expenses.

Our operations could be subject to earthquakes, power shortages and surges, telecommunications failures, water shortages, floods, fires, extreme weather conditions, medical epidemics and other natural or manmade disasters or business interruptions, for which we have limited insurance or are predominantly self-insured. The occurrence of any of these business disruptions could seriously harm our manufacturing operations and financial condition and increase our costs and expenses. Our ability to obtain raw materials, components and supplies for the manufacture, as well as the services of outside testing laboratories, of our third party customers’ products, for which we act as a contract manufacturer, could be disrupted, if the operations of these suppliers and/or labs is affected by a man-made or natural disaster or other business interruption. Our corporate headquarters and manufacturing facilities are located in California near major earthquake faults. The ultimate impact on us, our significant suppliers and our general infrastructure of being located near major earthquake faults and being consolidated in certain geographical areas is unknown, but our operations and financial condition could suffer in the event of a major earthquake or other natural disaster.

 

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

In 2018, we sold the majority of our research and development assets, including our development-stage immunotherapy product, bavituximab (as described in Note 1011 of the Notes to the accompanying consolidated financial statements)Consolidated Financial Statements). 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 million per occurrence or $10 million 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 positioncondition 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.

 

We have become increasingly dependent on information technology and any breakdown, interruption or breach of our information technology systems could subject us to liability or interrupt the operation of our business, which could have a material adverse effect on our business, financial condition, cash flows and results of operations.operations and cash flows.

We are increasingly dependent upon sophisticated information technology systems and infrastructure in connection with the conduct of our business. We must constantly update our information technology infrastructure and our various current information technology systems throughout the organization may not continue to meet our current and future business needs. Furthermore, modification, upgrade or replacement of such systems may be costly. In addition, due to the size and complexity of these systems, any breakdown, interruption, corruption or unauthorized access to or cyber-attack on these systems could create system disruptions, shutdowns or unauthorized disclosure of confidential information. While we attempt to take appropriate security and cyber-security measures to protect our data and information technology systems and to prevent such breakdowns and unauthorized breaches and cyber-attacks, these measures may not be successful and these breakdowns and breaches in, or attacks on, our systems and data may not be prevented. Such breakdowns, breaches or attacks may cause business interruption and could have a material adverse effect on our business, financial condition, cash flows and results of operations and cash flows and could cause the market value of our common shares to decline, and we may suffer financial damage or other loss, including fines or criminal penalties because of lost or misappropriated information.

 

 

 

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Our governance documents and state law provide certain anti-takeover measures which will discourage a third party from seeking to acquire us unless approved by the Board of Directors.

We have a rights plan that is designed to protect stockholders against unsolicited attempts to acquire control of us that do not offer a fair price to our stockholders as determined by our board of directors. Under the plan, the acquisition of 15% or more of our outstanding common stock by any person or group, unless approved by our board of directors, will trigger the right of our stockholders (other than the acquirer of 15% or more of our common stock) to acquire additional shares of our common stock, and, in certain cases, the stock of the potential acquirer, at a 50% discount to market price, thus significantly increasing the acquisition cost to a potential acquirer. In addition, our certificate of incorporation and by-laws contain certain additional anti-takeover protective devices. For example,

·no stockholder action may be taken without a meeting, without prior notice and without a vote; solicitations by consent are thus prohibited;
·special meetings of stockholders may be called only by our board of directors; and
·our board of directors has the authority, without further action by the stockholders, to fix the rights and preferences, and issue shares, of preferred stock. An issuance of preferred stock with dividend and liquidation rights senior to the common stock and convertible into a large number of shares of common stock could prevent a potential acquirer from gaining effective economic or voting control.

Further, we are subject to Section 203 of the Delaware General Corporation Law, which, subject to certain exceptions, restricts certain transactions and business combinations between a corporation and a stockholder owning 15% or more of the corporation’s outstanding voting stock for a period of three years from the date the stockholder becomes a 15% stockholder.

Although we believe these provisions and our rights plan collectively provide for an opportunity to receive higher bids by requiring potential acquirers to negotiate with our board of directors, they would apply even if the offer may be considered beneficial by some stockholders. In addition, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors, which is responsible for appointing the members of our management.

Our bylaws, as amended, provide that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.


Our bylaws, as amended, provide that, unless we consent in writing to an alternative forum, the Court of Chancery of the State of Delaware is the exclusive forum for any derivative action or proceeding brought on our behalf, any action asserting a breach of a fiduciary duty owed by any of our directors, officers, or other employees to us, any action asserting a claim against us arising pursuant to the Delaware General Corporation Law, our certificate of incorporation or our bylaws, any action to interpret, apply, enforce, or determine the validity of our certificate of incorporation or bylaws, or any action asserting a claim against us that is governed by the internal affairs doctrine. The choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees, which may discourage such lawsuits against us and our directors, officers and other employees.

 

18

Risks Related to the Ownership of Our Common Stock

 

A significant number of shares of our common stock are issuable pursuant to outstanding options, restricted stock units 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 April 30, 2019,2020, an aggregate of 7,264,7136,941,049 shares of common stock were reserved for issuance under outstanding stock options and restricted stock units, or available for future issuance under our stock incentive plans. Additionally, as of April 30, 2019,2020, there were 1,196,2611,148,735 shares of common stock reserved for and available for issuance under our Employee Stock Purchase Plan (the “ESPP”) and up to 6,826,435 shares of common stock issuable upon conversion of our outstanding 10.50% Series E Convertible Preferred Stock (the “Series E Preferred Stock”). The issuance of additional shares of common stock upon the exercise, release 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.

 

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$2.24 to $8.44 per share over the last three fiscal years ended April 30, 20192020 (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;
 ·significant changes in our financial results or that of our competitors, including our ability to continue as a going concern;
 ·our ability to meet our revenue guidance;
 ·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, 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 in the regulatory approval of our customers’ products which we manufacture;
 ·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.

 

 

 

 1915 

 

 

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.

 

We do not intend to pay dividends on our common stock, so any returns will be limited to the value of our stock.

We have never declared or paid any cash dividend on our common stock. We currently anticipate that we will retain future earnings, if any, for the development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends for the foreseeable future. Any return to stockholders will therefore be limited to the appreciation of their stock.

 

If securities or industry analysts do not publish research reports about us, or if they issue adverse opinions about our business, our stock price and trading volume could decline.

The research and reports that industry or securities analysts publish about us or our business will influence the market for our common stock. If one or more analysts who cover us issues an adverse opinion about us, our stock price would likely decline. If one or more of these analysts ceases research coverage of us or fails to regularly publish reports on us, we could lose visibility in the financial markets which, in turn, could cause our stock price or trading volume to decline. Further, if we fail to meet the market expectations of analysts who follow our stock, our stock price likely would decline.

 

Additional Risks Related to the Ownership of our Series E Preferred Stock

 

We may not be able to pay dividends on the Series E Preferred Stock.

We are incorporated in Delaware and governed by the Delaware General Corporation Law. Delaware law allows a corporation to pay dividends only out of surplus, as determined under Delaware law, or if there is no surplus, out of net profits for the fiscal year in which the dividend was declared and for the preceding fiscal year. Under Delaware law, however, we cannot pay dividends out of net profits if, after we pay the dividend, our capital would be less than the capital represented by the outstanding stock of all classes having a preference upon the distribution of assets. In addition, payment of our dividends depends upon our financial condition and other factors as our board of directors may deem relevant from time to time. Our business may not generate sufficient cash flow from operations or future borrowings may not be available to us in an amount sufficient to enable us to make distributions on our Series E Preferred Stock.

 

The market price of the Series E Preferred Stock could be substantially affected by various factors.

The market price of the Series E Preferred Stock will depend on many factors, which may change from time to time, including:

 

·prevailing interest rates, increases in which may have an adverse effect on the market price of the Series E Preferred Stock;
·trading prices of common and preferred equity securities issued by other biopharmaceutical companies;
·the annual yield from distributions on the Series E Preferred Stock, as compared to yields on other financial instruments;
·announcements of technological innovations or new commercial products by us or our competitors;
·publicity regarding actual or potential company-sponsored clinical trial and investigator-sponsored clinical trial results relating to products under development by us or our competitors;
·announcements of licensing agreements, joint ventures, strategic alliances, and any other transaction that involves the development, sale or use of our technologies;
·regulatory developments and product safety concerns;
·general economic and financial market conditions;
·government action or regulation;

20

·significant changes in the financial condition, performance and prospects of us and our competitors;
·changes in financial estimates or recommendations by securities analysts with respect to us, and our competitors in our industry;
·our issuance of additional preferred equity or debt securities; and
·actual or anticipated variations in quarterly operating results of us and our competitors.

16

 

As a result of these and other factors, holders of our Series E Preferred Stock may experience a decrease, which could be substantial and rapid, in the market price of the Series E Preferred Stock, including decreases unrelated to our operating performance or prospects.

 

Item 1B.Unresolved Staff Comments

 

Not applicable.

 

Item 2.Properties

 

Our corporate offices and manufacturing facilities are all located in close proximity in Tustin, California. We currently lease an aggregate of approximately 183,000158,000 square feet of office, warehousemanufacturing, laboratory and manufacturingwarehouse space in fivefour buildings under fourthree separate lease agreements.

 

We lease approximately 26,000 square feet for our corporate headquarters under a non-cancellable operating lease agreement that began April 2016 and terminates August 2023. The lease contains two separate option periods that could extend the lease term to August 2035.

 

We lease approximately 48,000 square feet of office, manufacturing and laboratory space under a non-cancellable operating lease agreement that began December 1998 and terminates December 2027. The lease contains two separate option periods that could extend the lease term to December 2037.

 

We lease approximately 84,000 square feet of manufacturing and laboratory space under a non-cancellable operating lease agreement that began July 2014 and terminates January 2027. The lease contains two separate option periods that could extend the lease term to January 2037.

 

We lease approximately 25,000 square feet of office and warehouse space under a non-cancellable operating lease agreement that began April 2016 and terminates August 2023. The lease contains two separate option periods that could extend the lease term to August 2035.

We believe that the space we lease is adequate to meet our current needs and that, if necessary, additional space would be available to accommodate any future growth.

 

Item 3.Legal Proceedings

 

In 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 or financial position.operations.

 

Item 4.Mine Safety Disclosures

 

Not applicable.

 

 2117 

 

 

PART II

Item 5.Market For Registrant’s Common Equity, Related Stockholder Matters And Issuer Purchases Of Equity Securities

 

Market Information

 

Our common stock is listed on The NASDAQ Capital Market under the trading symbol “CDMO.”

 

Holders of Common Stock

 

As of June 14, 2019,19, 2020, we had 327329 stockholders of record of our common stock. This number does not include beneficial owners whose shares are held in street name.

 

Securities Authorized for Issuance under Equity Compensation

The information included under Item 12 of Part III of this Annual Report is hereby incorporated by reference into this Item 5 of Part II of this Annual Report.

Recent Sales of Unregistered Securities

 

None.

 

Dividend Policy

 

Common Stock

We have never declared or paid cash dividends on our common stock. We do not anticipate paying any cash dividends in the foreseeable future. Any future determination to declare cash dividends will be made at the discretion of our Board of Directors and will depend on our financial condition, results of operations, capital requirements, general business conditions, and other factors that our Board of Directors may deem relevant. In addition, our ability to pay dividends is currently restricted by the terms of the Certificate of Designations of Rights and Preferences (the “Certificate of Designations”) with respect to our 10.50% Series E Convertible Preferred Stock (the “Series E Preferred Stock”).

Series E Preferred Stock

Our Series E Preferred Stock ranks senior to our common stock with respect to dividend rights. Holders of our Series E Preferred Stock are entitled to receive, when and as declared by our Board of Directors out of funds legally available for the payment of distributions, cumulative preferential cash dividends, payable in cash, at a rate of 10.50%per annum on the stated value of $25.00 per share, or $2.625 per shareper annum (in each case, as adjusted for any stock split, stock dividend, recapitalization, reclassification or any similar transaction).

The dividend rate on our Series E Preferred Stock will increase to a penalty rate of 12.50%per annum in the event we: (i) fail to pay dividends for any four consecutive or nonconsecutive quarterly dividend periods; or (ii) fail, for period of 180 consecutive days or more, to maintain the listing or quotation, as applicable, of our Series E Preferred Stock on the New York Stock Exchange, the NYSE MKT LLC, The NASDAQ Global Market, The NASDAQ Global Select Market or The NASDAQ Capital Market, or any successor to such national securities exchange.

Dividends on our Series E Preferred Stock accrue and accumulate on each issued and outstanding share of our Series E Preferred Stock on a daily basis from, and including, the original date of issuance of such share. Dividends on our Series E Preferred Stock are payable quarterly in arrears on or about the first day of each January, April, July, and October, as set forth in the Certificates of Designation. For each of the fiscal years ended April 30, 2020, 2019, and 2018, we paid aggregate cash dividends of approximately $4.3 million to the holders of issued and outstanding shares of our Series E Preferred Stock.

Purchases of Equity Securities by the Issuer and Affiliated Purchasers

None.

 

 

 

 

 2218 

 

 

Performance Graph

 

Notwithstanding any statement to the contrary in any of our previous or future filings with the SEC, the following information relating to the price performance of our common stock shall not be deemed to be “filed” with the SEC or to be “soliciting material” under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and it shall not be deemed to be incorporated by reference into any of our filings under the Securities Act of 1933, as amended, or the Exchange Act, except to the extent we specifically incorporate it by reference into such filing.

The following chart shows the performance from April 30, 20142015 through April 30, 20192020 of Avid Bioservices, Inc. common stock, compared with an investment in the stocks represented in the NASDAQ ICB: 4577 Pharmaceuticals Index and the NASDAQ U.S. Benchmark TR Index assuming the investment of $100 at the beginning of the period and the reinvestment of dividends, if any. The total return data for the comparative indexes were prepared by NASDAQ OMX Global Indexes.

 

COMPARISON OF FIVE-YEAR CUMULATIVE TOTAL RETURN
VALUE OF INVESTMENT OF $100 ON APRIL 30, 20142015

 

 

The underlying data for the foregoingpreceding graph is as follows:

 

 April 30,
2014
  April 30,
2015
  April 30,
2016
  

April 30,

2017

 

April 30,

2018

 

April 30,

2019

  April 30,
2015
 April 30,
2016
 April 30,
2017
  

April 30,

2018

 

April 30,

2019

 

April 30,

2020

 
Avid Bioservices, Inc. $100.00  $75.29  $20.35  $35.38  $30.13  $39.33  $100.00  $27.03  $46.99  $40.02  $52.24  $66.52 
NASDAQ ICB: 4577 Pharmaceuticals (subsector) $100.00  $117.61  $116.02  $125.41  $135.34  $154.48  $100.00  $98.65  $106.64  $115.07  $131.35  $145.31 
NASDAQ U.S. Benchmark TR Index $100.00  $112.61  $112.50  $133.63  $151.28  $170.47  $100.00  $99.90  $118.66  $134.34  $151.38  $150.21 

 

 

 

 2319 

 

 

Item 6.Selected Financial Data

 

The selected consolidated financial data set forth below as of April 30, 20192020 and 2018,2019, and for the fiscal years ended April 30, 2020, 2019 2018 and 2017,2018, are derived from our audited consolidated financial statements included elsewhere in this Annual Report. This information should be read in conjunction with those consolidated financial statements, the notes thereto, and with “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” The selected consolidated financial data set forth below as of April 30, 2018, 2017 2016 and 2015,2016, and for the fiscal years ended April 30, 20162017 and 2015,2016, are derived from our audited consolidated financial statements that are contained in Annual Reports previously filed with the SEC, not included herein.

 

  2020(a)  2019(b)  2018  2017  2016 
  (in thousands, except for per share amounts) 
                
Revenues $59,702  $53,603  $53,621  $57,630  $44,357 
                     
(Loss) income from continuing operations $(10,466) $(5,056) $(20,563) $1,393  $3,597 
                     
Income (loss) from discontinued operations, net of tax(c) (d) $  $841  $(1,250) $(29,552) $(59,249)
                     
Net loss $(10,466) $(4,215) $(21,813) $(28,159) $(55,652)
                     
Net loss attributable to common stockholders(e) $(15,152) $(8,901) $(26,499) $(32,799) $(60,136)
                     
Basic and diluted net (loss) income per common share attributable to common stockholders:                    
                     
Continuing operations $(0.27) $(0.17) $(0.53) $(0.09) $(0.03)
                     
Discontinued operations $  $0.01  $(0.03) $(0.79) $(1.92)
                     
Net loss per share attributable to common stockholders $(0.27) $(0.16) $(0.56) $(0.88) $(1.95)
                     
Cash and cash equivalents $36,262  $32,351  $42,265  $46,799  $61,412 
Working capital $15,283  $28,156  $29,964  $26,943  $24,234 
Total assets $107,620  $78,395  $95,760  $118,112  $109,043 
Operating lease liabilities, less current portion $21,244  $  $  $  $ 
Other long-term liabilities $  $93  $  $  $ 

  Fiscal Year Ended April 30, 
Statement of Operations Data: 2019(a)  2018  2017  2016  2015 
  (in thousands, expect for share and per share amounts) 
                
Revenues $53,603  $53,621  $57,630  $44,357  $26,744 
(Loss) income from continuing operations $(5,056) $(20,563) $1,393  $3,597  $(6,799)
Income (loss) from discontinued operations, net of tax(b) (c) $841  $(1,250) $(29,552) $(59,249) $(43,559)
Net loss $(4,215) $(21,813) $(28,159) $(55,652) $(50,358)
Net loss attributable to common stockholders(d) $(8,901) $(26,499) $(32,799) $(60,136) $(54,054)
Basic and diluted net (loss) income per common share attributable to common stockholders:                    
Continuing operations $(0.17) $(0.53) $(0.09) $(0.03) $(0.40)
Discontinued operations $0.01  $(0.03) $(0.79) $(1.92) $(1.67)
Net loss per share attributable to common stockholders $(0.16) $(0.56) $(0.88) $(1.95) $(2.07)
                     
   As of April 30, 
Balance Sheet Data:  2019(a)   2018   2017   2016   2015 
   (in thousands) 
Cash and cash equivalents $32,351  $42,265  $46,799  $61,412  $68,001 
Working capital $28,156  $29,964  $26,943  $24,234  $43,192 
Total assets $78,395  $95,760  $118,112  $109,043  $97,464 
Capital lease, less current portion $93  $  $  $  $ 
Accumulated deficit $(560,605) $(559,129) $(537,435) $(509,276) $(453,624)
Stockholders' equity $53,068  $55,738  $53,582  $50,074  $59,035 

_________________

 

____________

(a)On May 1, 2019, we adopted ASC 842,Leases, which requires lessees to recognize right-of-use assets and lease liabilities for operating leases with a lease term greater than one year (as described in Note 2 of the Notes to Consolidated Financial Statements). We adopted ASC 842 using the modified retrospective method. Accordingly, results for reporting periods beginning after May 1, 2019 are presented in accordance with ASC 842, while prior period amounts are not adjusted and continue to be reported under the accounting standards that were in effect prior to May 1, 2019.
(b)On May 1, 2018, we adopted ASC 606,Revenue from Contracts with Customers, using the modified retrospective method to all contracts not completed as of May 1, 2018 (as described in Note 2 of the Notes to the accompanying consolidated financial statements)Consolidated Financial Statements). Under the modified retrospective method, results for the reporting periods beginning on or after May 1, 2018 are presented in accordance with ASC 606, while prior period amounts are not adjusted and continue to be reported under the accounting standards that were in effect prior to May 1, 2018.
(b)(c)For all periods presented, the operating results of our former research and development segment are reported as income (loss) from discontinued operations, net of tax (as described in Note 1 of the Notes to the accompanying consolidated financial statements)Consolidated Financial Statements).
(c)(d)Income (loss) from discontinued operations, net of tax for fiscal years 2019 and 2018 include a gain on sale of research and development assets before tax of $1,000$1.0 million and $8,000,$8.0 million, respectively (as described in Note 1011 of the Notes to the accompanying consolidated financial statements)Consolidated Financial Statements).
(d)(e)Net loss attributable to common stockholders represents our net loss plus Series E preferred stock accumulated dividends.

 

 

 

 2420 

 

Item 7.Management’s Discussion And Analysis Of Financial Condition And Results Of Operations

The following discussion is includedand analysis should be read in conjunction with “Item 6—Selected Financial Data” and our audited Consolidated Financial Statements and the related notes thereto set forth in “Item 8—Financial Statements and Supplementary Data”. In addition to describehistorical information, this discussion and analysis contains forward-looking statements, including statements regarding the anticipated impact of the ongoing COVID-19 global pandemic on our business operations that involve risks, uncertainties and assumptions. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors including, but not limited to, those set forth under “Item 1A—Risk Factors” and elsewhere in this Annual Report.

For discussion related to changes in financial positioncondition and our results of operations for eachfiscal year 2019 compared to fiscal year 2018, refer to “Part II, Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the three fiscal years in the periodyear ended April 30, 2019. The audited consolidated financial statements and notes thereto contain detailed information that should be referred to in conjunction2019, which was filed with this discussion.the SEC on June 27, 2019.

 

Overview

 

We are a dedicated contract development and manufacturing organization (“CDMO”) that provides a comprehensive range of services from process development to Current Good Manufacturing Practices (“CGMP”) clinical and commercial manufacturing, focused on biopharmaceutical productsdrug substances derived from mammalian cell culture. With over 2527 years of experience producing monoclonal antibodies and recombinant proteins, in batch, fed-batch and perfusion modes, our services include CGMP clinical and commercial product manufacturing, purification, bulk packaging, release and stability testing and regulatory submissions and 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. All our services are available as either stand-alone or bundled for full development and manufacturing programs. 

 

Strategic Objectives

 

The following are our near-term strategic objectives:

 

·Expand existing customer relationshipsInvest in additional manufacturing capacity and diversifyresources required for us to achieve our customer base by securing additional customerslong-term growth strategy and meet the growth-demand of our customers’ programs, moving from development through to supportcommercial manufacturing;
·Broaden our future potential revenue growth beyond fiscal year 2019;market awareness through a diversified yet flexible marketing strategy;
·Continue to invest in manufacturing facilitiesexpand our customer base and infrastructure to maximize our facility utilization and support our customers’programs with existing customers for both process development and clinical and commercial manufacturing requirements;service offerings; and
·BroadenIncrease our sales force by hiring sales representativesoperating profit margin to execute our business development initiativesbest in key markets.class industry standards.

 

We are currently inFiscal Year 2020 Highlights

Reported revenues of $59.7 million for fiscal 2020, an increase of 11%, or $6.1 million, from fiscal 2019, representing an all-time high for us.

Increased our customer base and expanded the scope of work with multiple existing customers to increase the number of manufacturing batches and/or scale of production, including entering into a new contract manufacturing agreement with one of the world’s leading pharmaceutical companies to provide process transfer and clinical manufacturing services to the support the development of expandinga novel therapeutic candidate.

21

Personnel

Added key members to our executive leadership team with the appointments of Timothy Compton as our Chief Commercial Officer and optimizingRichard Richieri as our Chief Operations Officer. Mr. Compton is focused on driving the continued growth of our CDMO business, including the ongoing expansion of our commercial and clinical customer base. Mr. Richieri oversees our process development, capabilitiesclinical and laboratory space, which includes expandingcommercial manufacturing, technical support and facilities functions, and focuses on streamlining operations, building internal efficiencies and strategic planning for future growth.

Appointed Catherine Mackey, Ph.D. to our board of directors as an independent member.

Facilities

Initiated the pre-engineering, design and permitting work required that will allow us to break ground on a facility expansion when we determine it is appropriate. We expect that such expansion could take 12 to 18 months to complete. While a specific kick-off date has not yet been established for this expansion, we believe that customer demand will require additional capacity in the next 12 to 24 months and we expect to be prepared to accommodate that demand.

Advanced the construction stages of the installation of a pharmaceutical-grade water system within our Myford Facility. We expect the installation and validation of the pharmaceutical grade water system to take place in late calendar year 2020.

Completed the expansion of our total available process development laboratory space, upgradingupgraded the infrastructure and equipment within our existing process development laboratories, and implementingimplemented new state-of-the-art technologies and equipment designed to facilitate efficient, high-throughput development of innovative upstream and downstream manufacturing processes.

Impact of COVID-19 Pandemic

In March 2020, the World Health Organization declared the global novel coronavirus disease (“COVID-19”) outbreak a pandemic. To date, the COVID-19 pandemic has not had a significant impact on our operations, as we have been 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 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 actions taken to contain it or treat its impact and the economic impact on local, regional, national and international markets. We are strategically conductingwill continue to assess the potential impact of the COVID-19 pandemic on our business, financial condition, and results of operations. For a further discussion of potential risks to our business from the COVID-19 pandemic, see“Part I, Item 1A—Risk Factors” of this work in phases to avoid disruption to current customer programs.Annual Report.

 

Performance and Financial Measures

 

In assessing the performance of our business, we consider a variety of performance and financial measures. The key indicators of the financial condition and operating performance of our business are contract manufacturing revenue,revenues, gross profit, selling, general and administrative expenses and operating income.

22

 

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.

 

Revenues

 

Revenues are derived from contract manufacturing 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 product(s)products derived from mammalian cell culture covering clinical through commercial manufacturing runs. The process development revenue stream generally represents revenue from non-manufacturing related services associated with the custom development of a manufacturing process and analytical methods for a customer’s product. 

25

 

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 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. 

 

We regularly analyze the components of gross profit as well as gross profit as a percentage of revenues. Specifically we look at the gross profit margins of our manufacturing revenue and process development revenue, and the effects of idle capacity, if any, on these revenue streams.

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, project management, 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, project management, 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(in thousands)

 

The following table compares the operating results from our continuing operations for the fiscal years ended April 30, 2020, 2019 and 2018 and 2017, which are further discussed below.(in thousands):

 

  Fiscal Year Ended April 30, 
  2019(1)  2018  2017 
    
Revenues $53,603  $53,621  $57,630 
Cost of revenues  46,379   56,545   38,259 
    Gross profit (loss)  7,224   (2,924)  19,371 
             
Operating expenses:            
   Selling, general and administrative  12,846   16,456   18,079 
   Restructuring charges     1,258    
    Total operating expenses  12,846   17,714   18,079 
Operating income (loss)  (5,622)  (20,638)  1,292 
Interest and other income, net  282   75   101 
Income (loss) from continuing operations before income taxes $(5,340) $(20,563) $1,393 
   Income tax benefit  284       
Income (loss) from continuing operations $(5,056) $(20,563) $1,393 

_____________

(1)On May 1, 2018, we adopted ASU 2014-09, Revenue from Contracts (Topic 606): Revenue from Contracts with Customers (“ASC 606”), using the modified retrospective method applied to all contracts not completed as of May 1, 2018. Under the modified retrospective method, results for reporting periods beginning after May 1, 2018 are presented under ASC 606, while prior period amounts are not adjusted and continue to be reported in accordance with our historic accounting under the accounting standards in effect for the prior period. Refer to Note 2, Summary of Significant Accounting Policies—Accounting Standards Adopted in Fiscal Year 2019, in the accompanying Notes to Consolidated Financial Statements for details regarding the adoption of ASC 606.

  Fiscal Year Ended April 30, 
  2020  2019  2018 
Revenues $59,702  $53,603  $53,621 
Cost of revenues  55,770   46,379   56,545 
Gross profit (loss)  3,932   7,224   (2,924)
             
Operating expenses:            
Selling, general and administrative  14,517   12,846   16,456 
Loss on lease termination  355       
Restructuring charges        1,258 
Total operating expenses  14,872   12,846   17,714 
Operating loss  (10,940)  (5,622)  (20,638)
Interest and other income, net  474   282   75 
Loss from continuing operations before income taxes  (10,466)  (5,340)  (20,563)
Income tax benefit     284    
Loss from continuing operations, net of tax $(10,466) $(5,056) $(20,563)

 

 

 

 2623 

 

Fiscal Year 20192020 Compared to Fiscal Year 20182019

 

Revenues

 

Revenues were $53,603$59.7 million in fiscal 2020, compared to $53.6 million in fiscal 2019, and were flatan increase of approximately $6.1 million, or 11%. The increase in revenues can be attributed to a $8.6 million increase in manufacturing revenue primarily due to an increase in the number of manufacturing runs in-process and/or completed in fiscal 2020 compared to $53,621 in fiscal 2018. In late fiscal 2018 we secured several new customers who contributed significantly to revenue in fiscal 2019. Our incremental revenues recognized from a more diversified customer base were2019, partially offset by a reductiondecrease in manufacturing demand from our, historically, two largest customers.process development revenue. The net changeincrease in revenuerevenues was attributed to the following components represented as a percentage of revenue:our revenue streams:

 

Attributable to% of Revenue
Net increase in revenue from the adoption of ASC 60624.7%
Net decrease in revenue from our, historically, two largest customers due to a reduction in manufacturing demand during fiscal 2019, excluding the impact of the adoption of ASC 606(39.9%)
Net change in revenues from all other customers, excluding the impact of the adoption of ASC 60615.2%
Total0.0%
  $ millions 
Net increase in manufacturing revenues $8.6 
Net decrease in process development revenues  (2.5)
Total increase in revenues $6.1 

Additionally, growth in manufacturing revenue during fiscal 2020 was impacted by a production interruption related to a problem with a specific piece of equipment, which resulted in the termination of certain in-process manufacturing runs and the postponement of other manufacturing runs scheduled to commence during fiscal 2020. During the fourth quarter of fiscal 2020, we implemented what we believe was the necessary remediation for the specific piece of equipment that resulted in the production interruption. We are currently progressing through the confirmation stage of this remediation during which we are running multiple revenue-generating production campaigns to confirm the successful remediation of the equipment issue. We expect the confirmation stage of this remediation to be completed in the coming months.

 

Gross Profit (Loss)

 

Gross profit was $7,224$3.9 million in fiscal 2020, compared to $7.2 million in fiscal 2019, compared to a decrease of approximately $3.3 million, and gross loss of $2,924 inmargins for fiscal 2018, an increase of $10,148 primarily due to the variability of manufacturing costs from product to product. Gross margins2020 and fiscal 2019 were a positive 13.5%7% and a negative 5.5%13%, respectively. Excluding the $3,500 favorable impact from the adoption of ASC 606, the increaseThe $3.3 million decrease in gross profit for fiscal 2020 was attributableprimarily attributed to decreased manufacturing laborhigher facility and overheadequipment related costs primarily related to the production interruption noted above, planned growth costs associated with payroll and related costs, and increased depreciation expense from the variabilityacquisition of manufacturing costs from product to product.new equipment, which were partially offset by an increase in revenues.

 

Selling, General and Administrative Expenses

 

SG&A expenses were $12,846$14.5 million in fiscal 2020, compared to $12.8 million in fiscal 2019, compared to $16,456 in fiscal 2018, a decreasean increase of $3,610approximately $1.7 million, or 22%13%. As a percentage of revenue, SG&A expenses for the fiscal years 2020 and 2019 and 2018 were 24.0% and 30.7%, respectively.both 24%. The net decreaseincrease in SG&A expenses werewas attributed to the following components:

 

Attributable to   
Costs associated with the transition of our business to a dedicated CDMO:    
Increase from settlement of a derivative and class action complaint resolved during the first quarter of fiscal 2018 $1,500 
Decrease in payroll and related costs  (2,298)
Decrease in legal and other professional consulting fees  (1,298)
Write-off of a long-term equipment deposit  (1,023)
Decrease in administrative facility costs  (927)
Net change in all other non-recurring SG&A expenses  (397)
Subtotal of net change in SG&A expenses associated with business transition $(4,443)
     
SG&A expenses:    
Increase in bonus related to achievement level of corporate goals $657 
Increase in stock-based compensation  301 
Net change in all other SG&A expenses  (125)
Subtotal of net change in SG&A expenses $833 
Total $(3,610)

  $ millions 
Increase in separation related expenses $0.8 
Increase in payroll and benefit costs  0.6 
Increase in stock-based compensation expense  0.5 
Decrease in accrued bonus expense  (0.5)
Net increase in all other SG&A expenses  0.3 
Total increase in SG&A expenses $1.7 

 

 

 

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Restructuring Charges in Fiscal 2018Loss on Lease Termination

During fiscal year 2018, we incurred restructuring charges of $1,588 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 consolidated financial statements). 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. Of the total restructuring charges incurred, $1,258 was related to our contract manufacturing services segment and $330 was related to our discontinued research and development segment. The restructuring costs associated with our discontinued research and development segment are included in loss from discontinued operations in the accompanying consolidated financial statements for the fiscal year ended April 30, 2018. We did not incur any restructuring charges during the fiscal years ended April 30, 2019 or 2017.

 

In the second quarter of fiscal 2020, we terminated an operating lease for one of our non-manufacturing facilities that was primarily utilized for warehouse space. The lease termination was primarily driven by our efforts to reduce costs by leveraging available warehouse space in our other facilities, which we expect will save us approximately $1.3 million in the aggregate over a period of four years. In connection with the termination of this lease, we removed the corresponding operating lease right-of-use asset and liability balances from our consolidated balance sheet and recognized a loss of $0.4 million. Additionally, the lease termination released $0.3 million of restricted cash that was pledged as collateral under a letter of credit required by the terminated lease.


Operating Loss

 

Operating loss was $5,622, or a negative 10.5% of revenue,$10.9 million for fiscal 20192020, compared to an operating loss of $20,638, or a negative 38.5% of revenue,$5.6 million for fiscal 2019. Of this $5.3 million increase in the prior fiscal year. Of the $15,016 improvement in year-over-year operating loss $10,148for fiscal 2020, approximately $3.3 million was attributable to a decrease in gross profit, improvement, $3,610 tocombined with an increase in SG&A decreaseexpenses of approximately $1.7 million and no restructuring chargesa $0.4 million loss recognized in fiscal 2019 compared to fiscal 2018 that resulted in a decreaseconnection with the termination of $1,258, as notedthe operating lease discussed above.

 

Income Tax Benefit

 

In September 2018,fiscal 2019, we recognized a $1,000$1.0 million gain in discontinued operations, before taxes, for the sale of our r84 technology (as described in Note 1011 of the Notes to the accompanying consolidated financial statements)Consolidated Financial Statements). In accordance with the “Intraperiod Tax Allocation” rules under ASC 740:740,Income Taxes, which requires the allocation of an entity’s total annual income tax provision among continuing operations and, in our case, discontinued operations for fiscal 2019, we recorded a tax benefit in continuing operations, with an offsetting tax expense of $284$0.3 million recorded in discontinued operations.

Fiscal Year 2018 Compared to Fiscal Year 2017

Revenues

Revenues were $53,621 in fiscal 2018 compared to $57,630 in fiscal 2017, a decrease of $4,009 or 7.0%. The decrease in revenues during fiscal 2018 was primarily due to fewer manufacturing runs completed and shipped compared to the prior year, which can primarily be attributed to a decrease in manufacturing demand from our, historically, two largest customers.

Gross Profit (Loss)

During fiscal 2018, gross margins declined to a negative 5.5% on a loss of $2,924 compared to gross margins of 33.6% for fiscal 2017 on a profit of $19,371. The decrease in gross margins was primarily driven by idle capacity costs incurred in fiscal 2018 compared to fiscal 2017, during which we incurred no idle capacity costs. The fiscal 2018 decline was further impacted by higher manufacturing costs associated with lower facility utilization in addition to the variability of manufacturing costs form product to product.

Selling, General and Administrative Expenses

The decrease in SG&A expenses of $1,623, or 9.0%, during fiscal 2018 compared to fiscal 2017 was primarily due to current period decreases in payroll and related costs and non-employee director fees. The decrease in payroll and related costs can primarily be attributed to a decrease in headcount and other personnel costs related to our efforts to align our cost structure to match the needs of our current CDMO operations combined with a decrease in stock-based compensation expense. The decrease in non-employee director fees is attributed to the settlement terms of a derivative and class action complaint approved by the Court of Chancery of the State of Delaware on July 27, 2017, pursuant to which our former non-employee directors agreed to pay or cause to be paid $1,500 to us, which non-recurring amount was applied against non-employee director fees during the fiscal quarter of fiscal 2018. These fiscal 2018 decreases in SG&A expenses were partially offset by non-recurring costs related to the write-off of a long-term equipment deposit, severance and other certain non-recurring costs associated with the transition of our business to a dedicated CDMO.

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Operating Loss

Operating loss was $20,638, or a negative 38.5% of revenue, for fiscal 2018 compared to an operating income of $1,292, or a 2.2% of revenue, in fiscal 2017. The $21,930 decrease was attributable to a decline in gross profit of $22,295 and an SG&A decrease of $1,623, partially offset by restructuring charges of $1,258 in fiscal 2018, as noted above.

 

Discontinued Operations

 

As a result of the sale of our r84PS-targeting and PS-targetingr84 technologies in Septemberfiscal 2018 and February 2018,fiscal 2019, respectively (as described in Note 1011 of the Notes to the accompanying consolidated financial statements)Consolidated Financial Statements), the abandonment of our remaining research and development assets, and the strategic shift in our corporate direction to focus solely on our CDMO business, the operating results of our former research and development segment have been excluded from continuing operations and reported as income (loss) from discontinued operations, net of tax, in the accompanying consolidated financial statements for all periods presented. The gains of $1,000$1.0 million and $8,000, respectively, which$8.0 million that were recorded in connection with the aforementioned sales of our PS-targeting and r84 and PS-targeting technologies, whichrespectively, are included in income (loss) from discontinued operations, net of tax, in the accompanying Consolidated Statements of Operations and Comprehensive Loss for the fiscal years ended April 30, 2019 and 2018, respectively. There were no operating results from discontinued operations during the fiscal year ended April 30, 2020.

 

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. While our significant accounting policies are more fully described in Note 2 of the Notes to the accompanying consolidated financial statements,Consolidated Financial Statements, we believe the following accounting policies to be critical to the assumptions and estimates used in the preparation of our consolidated financial statements.

 

25

Revenue Recognition

 

On May 1, 2018, we adopted Accounting Standards Update (“ASU”)No. 2014-09,Revenue from Contracts with Customers (Topic 606), and its subsequent updates (codified as “ASC 606”)ASC 606), using the modified retrospective method applied to all contracts not completed as of May 1, 2018. Under the modified retrospective method,method. Accordingly, results for reporting periods beginning after May 1, 2018 are presented underin accordance with ASC 606, while prior period amounts arehave not been adjusted and continue to be reported in accordance with our historic accounting under the accounting standards that were in effect for those periods.prior to our adoption of ASC 606.

 

The cumulative effect of adoptingUnder ASC 606, resulted in a one-time adjustment of $2,739 to the opening balance of accumulated deficit which is reflected in the accompanying Consolidated Statements of Stockholders’ Equity for the fiscal year ended April 30, 2019. The cumulative effect adjustment relates to the recognition ofwe recognize revenue and related costs for customer contracts thatwhen we transfer promised goods or services over time. Under ASC 606,to customers in an amount that reflects the timing of the recognition of revenue and the related cost of revenue associated withconsideration to which we expect to be entitled in exchange for those goods or services. To determine revenue recognition for contracts with customers we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy a performance obligation.

Revenue recognized from services provided to customers with no alternative useunder our customer contracts are disaggregated into manufacturing and process development revenue streams.

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 date to the most current estimates for the entire cost of the performance obligation. Under these customer contracts the customer retains control of the product as it is being created or enhanced by our services and/or we are entitled to compensation for progress to date that includes an element of profit margin.

Our revenues derived from contract manufacturing services provided under our customer contracts are disaggregated into the following revenue streams.

29

Manufacturing revenue

The manufacturing revenue stream generally represents revenue from the manufacturing of customer product(s) derived from mammalian cell culture covering clinical through commercial manufacturing runs. Under a manufacturing contract, a quantity of manufacturing runs areis ordered and the product is manufactured according to the customer’s specifications and typically only one performance obligation is included. Each manufacturing run represents a distinct service that is sold separately and has stand-alone value to the customer. The product(s)products are manufactured exclusively for a specific customer and have no alternative use. The customer retains control of theirits product during the entire manufacturing process and can make changes to the process or specifications at theirits request. Under these agreements, we are entitled to consideration for progress to date that includes an element of profit margin. Revenue

Process development revenue

Process development revenue generally represents revenue from services associated with this streamthe 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.

Process development revenue

The process development revenue stream generally represents revenue from non-manufacturing related services associated with the custom development of a manufacturing process and analytical methods for a customer’s product. 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 theirits specifications and typically only one performance obligation is included. Each process represents a distinct service that is sold separately and has stand-alone value to the customer. The customer also retains control of theirits product as the product is being created or enhanced by our services and can make changes to theirits process or specifications upon request. Revenue associated with this stream 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.

 

The timing of revenue recognition, billings and cash collections results in billed trade receivables, 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 tradeaccounts receivables on the consolidated 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 will convert to contract manufacturing revenue as we perform our obligations under the contract.

The transaction price for services provided under our customer contracts reflect 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.

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, 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.

 

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. In addition,As of April 30, 2020, we currently do not have any unsatisfied performance obligations for contracts greater than one year.

 

Costs incurred to obtain a contract are not material. These costs are generally employee sales commissions, which are expensed when incurred and included in selling, general and administrative expense in the accompanying condensed consolidated statements of operations and comprehensive loss.

26

 

Prior to theour adoption of ASC 606 on May 1, 2018, revenue was generally recognized when all of the following criteria arewere met: (i) persuasive evidence of 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.

Stock-based Compensation

 

We account for stock options, restricted stock units and other stock-based awards granted under our equity compensation plans in accordance with the authoritative guidance for stock-based 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.periods, which is generally the vesting period. The fair value of restricted stock units is measured at the grant date based on the closing market price of our common stock on the date of grant, and is recognized as expense on a straight-line basis over the period of vesting. Forfeitures are recognized as a reduction of stock-based compensation expense as they occur. As of April 30, 2019,2020, there were no outstanding stock-based awards with market or performance conditions.

 

30

The estimated fair value of stock options are measured at the grant date, using a fair value based method, such as a Black-Scholes option valuation model, and is amortized as compensation expense on a straight-line basis over the requisite service period of the award, which is generally the vesting period. The use of a valuation model requires us to make certain estimates and assumptions with respect to selected model inputs. The expected volatility is based on the daily historical volatility of our common stock covering the estimated expected term. The expected term of options granted reflects actual historical exercise activity and assumptions regarding future exercise activity of unexercised, outstanding options. The risk-free interest rate is based on U.S. Treasury notes with terms within the contractual life of the option at the time of grant. The expected dividend yield assumption is based on our expectation of future dividend payouts. We have never declared or paid any cash dividends on our common stock and currently do not anticipate paying such cash dividends.

 

If factors change and we employ different assumptions in the determination of fair value in future periods, the stock-based compensation expense that we record may differ significantly from what we have recorded in the current period. There are a number of factors that affect the amount of stock-based compensation expense, including the number of employee options granted during subsequent fiscal years, the price of our common stock on the date of grant, the volatility of our stock price, the estimate of the expected life of options granted and the risk-free interest rates.

Liquidity and Capital Resources

 

The accompanying consolidated financial statements have been prepared assuming we will continue as a going concern, which contemplates the realizationOur principal sources of assets and the satisfaction of liabilities in the normal course of business. At April 30, 2019, we had $32,351 inliquidity are our existing cash and cash equivalents. As of April 30, 2020, we had cash and cash equivalents of $36.3 million. Excluding the cash loan proceeds of $4.4 million received in April 2020 under a promissory note pursuant to the Paycheck Protection Program (the “PPP”) established pursuant to the Coronavirus Aid, Relief, and Economic Security Act of 2020 (the “CARES Act”) administered by the U.S. Small Business Administration (“SBA”), which proceeds were subsequently repaid in full to the lender in May 2020 (as described in Note 3 of the Notes to Consolidated Financial Statements), we would have had cash and equivalents of $31.9 million as of April 30, 2020. Our ability to fund our operations is dependent on the amount of cash on hand and our ability to generate positive cash flow to sustain our current operations.

We have expended substantial funds oncurrently anticipate that our contract manufacturing businesscash and historically, oncash equivalents as of April 30, 2020, excluding the aforementioned $4.4 million in loan proceeds that were returned to the lender thereof in May 2020, combined with our research and development business, which we discontinued in fiscal year 2018. As a result, we have historically experienced losses and negativeprojected cash flowsreceipts from operations sinceservices to be rendered under our inception and we expect negative cash flows from operations to continue until we can generateexisting customer contracts, will be sufficient revenue to generate positive cash flow from operations. We plan to fund our operations using our existing cash and cash equivalents and cash generatedfor at least the next 12 months from services provided under our customer contracts. the date of this Annual Report.

In the event we are unable to securegenerate sufficient additional manufacturing services projectscash flow to support our current operations, we may need to raise additional capital in the equity markets in order to fund our future operations. We may raise funds through the issuance of debt or through the public offering of securities. There can be no assurance that equity financingthese financings will 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 and economic and market conditions. Further, global financial crises and economic downturns, including those caused by widespread public health crises such as the COVID-19 pandemic, may cause extreme volatility and disruptions in capital and credit markets, and may impact our ability to raise additional capital when needed on acceptable terms, if at all. If we are unable to fund our continuing operations through these sources, 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. Any of these actions could materially harm our business, financial condition, results of operations, and future prospects. Further, we performed an analysis and concluded that based on our cash and cash equivalents as of April 30, 2019 in conjunction with cash generated from services provided under our customer contracts will provide us with adequate cash on hand to support our operations for at least one year from the issuance date of this Annual Report.

 

Cash Flow Analysis

 

Significant components of the changes in

27

The following table presents our cash flows from operating, investing and financing activities for the fiscal years ended April 30, 2020, 2019 and 2018 and 2017 are as follows:(in thousands):

 

  Fiscal Year Ended April 30, 
  2019  2018  2017 
Net cash used in operating activities $(11,595) $(25,992) $(39,169)
Net cash provided by (used in) investing activities  4,544   (793)  (3,059)
Net cash (used in) provided by financing activities  (2,863)  22,251   28,165 
  Fiscal Year Ended April 30, 
  2020  2019  2018 
Cash, cash equivalents and restricted cash(1) $36,612  $33,501  $43,415 
Net cash provided by (used in) operating activities  5,827   (11,595)  (25,992)
Net cash (used in) provided by investing activities  (3,812)  4,544   (793)
Net cash provided by (used in) financing activities  1,096   (2,863)  22,251 

___________

 

(1)As of April 30, 2020, 2019 and 2018, cash, cash equivalents and restricted cash included $0.4 million, $1.2 million and $1.2 million, respectively, that was restricted from general use, related to cash that was pledged as collateral under letters of credit under the terms of certain facility lease agreements.

Net Cash Provided by (Used in) Operating Activities

 

During fiscal 2020, net cash provided by operating activities increased by $17.4 million to $5.8 million from $11.6 million of net cash used in operating activities during fiscal 2019.

 

31

Cash Used In Operating ActivitiesNet cash provided by operating activities during fiscal 2020 was a result of an $10.5 million net loss, as increased to account for non-cash adjustments to net loss of $5.6 million primarily related to depreciation and amortization and stock-based compensation, and cash flows from the net change in operating assets and liabilities of $10.7 million.

 

Net cash used in operating activities represents our net loss, as reported, adjustments to reconcile net loss to net cash used in operating activities and net changes in the timing of cash flows as reflected by the changes in operating assets and liabilities.

Net cash used in operating activities induring fiscal 2019 was primarily attributable to a result of a $4.2 million net loss of $4,215;and a $1,000$1.0 million gain on the sale of certain research and development assets, offset by noncash charges forother non-cash adjustments to net loss of $4.5 million primarily related to depreciation and amortization and stock-based compensation, for an aggregate adjustmenta $4.6 million net change in the assets and liabilities of $3,468; combined withdiscontinued operations, and a net change inof certain other operating assets and liabilities of $10,848. The$6.3 million.

Net Cash (Used in) Provided by Investing Activities

During fiscal 2020, net changecash used in operating assets and liabilities was primarily dueinvesting activities increased by $8.4 million to the timing$3.8 million from $4.5 million of net cash receipts and expenditures associated with accounts receivable, inventories, accounts payable, contract liabilities and accrued liabilities of discontinued operations.provided by investing activities during fiscal 2019.

 

Net cash used in operatinginvesting activities induring fiscal 2018 was2020 consisted of $3.8 million used to acquire property and equipment primarily attributablerelated to a net loss of $21,813, combined with an aggregate adjustment of $2,208 to reconcile net loss to net cash used in operating activities, including an $8,000 gain on the sale of certain research and development assets, offset by noncash charges for depreciation and amortization and stock-based compensation, and a net change in operating assets and liabilities of $1,971. The net change in operating assets and liabilities was primarily due to the timing of cash receipts and expenditures associated with accounts receivable, inventories, accrued payroll and related costs, contract liabilities and the assets and accrued liabilities of discontinued operations.

Net cash used in operating activities in fiscal 2017 was primarily attributable to a net loss of $28,159, offset by an aggregate adjustment of $5,827 to reconcile net loss to net cash used in operating activities, including noncash charges for depreciation and amortization and stock-based compensation, combined with a net change in operating assets and liabilities of $16,837. The net change in operating assets and liabilities was primarily due to the timing of cash receipts and expenditures associated with accounts receivable, inventories, accounts payable, contract liabilities and the liabilities of discontinued operations.

Cash Provided By (Used In) Investing Activities

Investing activities consist of capital expenditures for our manufacturing and development operations and includes proceeds from the sale of certain research and development assets associated with our discontinued research and development segment.operations.

 

Net cash provided by investing activities during fiscal 2019 consisted primarily of property and equipment acquisitions of $1,502 related to our manufacturing operations, offset by proceeds of $6,000$6.0 million related to the sale of certain research and development assets associated with our discontinued research and development segment, and $46 in proceeds from the sale of certainoffset by cash used to acquire property and equipment.equipment of $1.5 million.

 

Net Cash Provided by (Used in) Financing Activities

During fiscal 2020, net cash provided by financing activities increased by $4.0 million to $1.1 million from $2.9 million of net cash used in investingfinancing activities during fiscal 2018 consisted of property and equipment acquisitions of $3,793 related to our manufacturing operations, offset by proceeds of $3,000 related to the sale of certain research and development assets associated with our discontinued research and development segment.

Net cash used in investing activities during fiscal 2017 consisted of property and equipment acquisitions of $3,627 related to our manufacturing operations combined with a decrease in other assets of $568 primarily related to a tenant improvement allowance provided to us under a facility operating lease.

2019.

 

 

 

 3228 

 

Cash (Used In) Provided By Financing Activities

FinancingNet cash provided by financing activities consistduring fiscal 2020 consisted primarily of $4.4 million of loan proceeds received in April 2020 from issuancethe PPP (which loan was subsequently repaid in full in May 2020, as described in Note 3 of common and preferred stock,the Notes to Consolidated Financial Statements), $0.9 million attributable from the exercise of stock options, and $0.2 million attributable from the issuance of common stock under our employee stock purchase plan, offset by $4.3 million of cash used to pay preferred dividends to holders of our Series E Preferred Stock.

Net cash used in financing activities during fiscal 2019 consisted primarily of cash used to pay preferred dividends to holders of our Series E Preferred Stock of $4.3 million, partially offset by proceeds from the exercise of stock options of $1.3 million and proceeds from the issuance of common stock under our employee stock purchase plan cash dividends paid on preferred stock, and payments on capital leases.of $0.3 million.

 

Net cash used in financing activities was $2,863 in fiscal 2019. This included $4,325 in dividends paid on preferred stock, partially offset by $1,278 of proceeds from the exercise of stock options and $258 of proceeds from the issuance of common stock under our employee stock purchase plan.

Net cash provided by financing activities was $22,251 in fiscal 2018. This included $21,494 in net proceeds in connection with an underwritten public offering of our common stock at a public offering price of $2.25 per share, $4,193 in net proceeds from the sale of shares of our common stock under an At Market Issuance Sales Agreement, partially offset by $4,325 in dividends paid on preferred stock.

Net cash provided by financing activities was $28,165 in fiscal 2017. This included $17,759 in net proceeds from the sale of shares of our common stock under an At Market Issuance Sales Agreement, $12,691 in net proceeds from the sale of shares of our common stock under an Equity Distribution Agreement, $1,576 in net proceeds from the sale of shares of our Series E Preferred Stock under a separate At Market Issuance Sales Agreement, partially offset by $4,279 in dividends paid on preferred stock.

Capital Expenditures

 

Our capital expenditures were $1,502$3.8 million during fiscal 2019. We anticipate utilizing up to approximately $5,000 for capital expenditures in fiscal 2020, which includesincluded laboratory and manufacturing equipment;equipment, software and enhancements;enhancements, and for enhancingenhancements to our current laboratory and manufacturing facilities.

 

Contractual Obligations

 

Contractual obligations represent future cash commitments and liabilities under agreements with third parties, and exclude contractual liabilities already recorded on our consolidated balance sheet as current liabilities and contingent liabilities for which we cannot reasonably predict future payments.

The following chart representstable summarizes our contractual obligations as of April 30, 2019, aggregated by type:2020 (in thousands):

 

  Payments Due by Period 
  

 

Total

  Less than 1 year  

 

1-3 years

  

 

3-5 years

  More than 5 years 
Operating leases(1) $34,001  $2,972  $6,005  $6,257  $18,767 
Finance lease(2)  103   103          
Note payable(3)  4,379   4,379          
Total contractual obligations $38,483  $7,454  $6,005  $6,257  $18,767 

  Payments Due by Period 
  Total  < 1 year  1-3 years  4-5 years  After 5 years 
                
Operating leases (1) $23,473  $3,032  $6,309  $6,070  $8,062 
Capital lease  193  $90  $103       
Purchase obligations (2)  1,731   1,731          
Total contractual obligations $25,397  $4,853  $6,412  $6,070  $8,062 

______________

______________

(1)RepresentsPrimarily represents future minimum lease payments under our facility operating lease agreements as further described in Note 34 of the Notes to the accompanying consolidated financial statements.Consolidated Financial Statements.
(2)Represents non-cancellable purchase orders forour obligations under a capital lease agreement to finance certain consumables associated withsoftware.
(3)Represents our single-use bioreactorsobligations under a promissory note entered into in our Myford Facility.April 2020, evidencing an unsecured loan of $4.4 million (the “PPP Loan”) from the PPP pursuant to the CARES Act. As further described in Note 3 of the Notes to Consolidated Financial Statements, we elected to repay the PPP Loan in full in May 2020.

 

Off BalanceOff-Balance Sheet Arrangements.

 

We doAs of April 30, 2020, we did not have any off balanceoff-balance sheet arrangements, as defined in Item 303 of Regulation S-K.

Recently Issued Accounting Pronouncements

See Note 2,SummaryS-K, that have or are reasonably likely to have a current or future effect on financial condition, changes in financial condition, revenues or expenses, results of Significant Accounting Policies—Pending Adoption of Recent Accounting Pronouncements, in the accompanying Notesoperations, liquidity, capital expenditures or capital resources that is material to Consolidated Financial Statements for a discussion of recent accounting pronouncements and their effect, if any, on our consolidated financial statements.

investors.

 

 

 

 3329 

Recently Issued Accounting Pronouncements

For a discussion of recent accounting pronouncements applicable to us, please see Note 2,Summary of Significant Accounting Policies, of the Notes to Consolidated Financial Statements.

 

Item 7A.Quantitative And Qualitative Disclosures About Market Risk

 

Our cash and cash equivalents are primarily invested in money market funds with one major commercial bank with 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 risk in the event of default by 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 April 30, 2019,2020, such changes would not have a material adverse effect on our financial positioncondition or results of operations, based on historical movements in interest rates.

 

Item 8.Financial Statements And Supplementary Data

 

Index to Consolidated Financial Statements

Page
Report of Independent Registered Public Accounting Firm35
31
Consolidated Balance Sheets as of April 30, 20192020 and 2018201936
32
Consolidated Statements of Operations and Comprehensive Loss for each of the three years in the period ended April 30, 2019202037
33
Consolidated Statements of Stockholders’ Equity for each of the three years in the period ended April 30, 2019202038
34
Consolidated Statements of Cash Flows for each of the three years in the period ended April 30, 2019202039
35
Notes to Consolidated Financial Statements4036

 

 

 

 

 

 

 

 

 

 

 

 

 3430 

 

Report of Independent Registered Public Accounting Firm

 

To the Stockholders and the Board of Directors of Avid Bioservices, Inc.

Opinion on the Financial Statements

We have audited the accompanying consolidated balance sheets of Avid Bioservices, Inc. (the Company) as of April 30, 2019 and 2018, the related consolidated statements of operations and comprehensive loss, stockholders' equity and cash flows for each of the three years in the period ended April 30, 2019, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at April 30, 2019 and 2018, and the results of its operations and its cash flows for each of the three years in the period ended April 30, 2019, in conformity with U.S. generally accepted accounting principles.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as of April 30, 2019, based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) and our report dated June 27, 2019 expressed an unqualified opinion thereon.

Adoption of ASU No. 2014-09

As discussed in Note 2 to the consolidated financial statements, the Company changed its method for recognizing revenue as a result of the adoption of Accounting Standards Update (ASU) No. 2014-09, Revenue from Contracts with Customers (Topic 606), and the amendments in ASUs 2015-14, 2016-08, 2016-10 and 2016-12
To the Stockholders and the Board of Directors of Avid Bioservices, Inc.

Opinion on the Financial Statements

We have audited the accompanying consolidated balance sheets of Avid Bioservices, Inc. (the Company) as of April 30, 2020 and 2019, the related consolidated statements of operations and comprehensive loss, stockholders’ equity and cash flows for each of the three years in the period ended April 30, 2020, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at April 30, 2020 and 2019, and the results of its operations and its cash flows for each of the three years in the period ended April 30, 2020, in conformity with U.S. generally accepted accounting principles.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s internal control over financial reporting as of April 30, 2020, based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) and our report dated June 30, 2020 expressed an unqualified opinion thereon.

Adoption of ASU No. 2014-09

As discussed in Note 2 to the consolidated financial statements, the Company changed its method for recognizing revenue as a result of the adoption of Accounting Standards Update (ASU) No. 2014-09,Revenue from Contracts with Customers (Topic 606), and the amendments in ASUs 2015-14, 2016-08, 2016-10 and 2016-02 effective May 1, 2018.

Adoption of ASU No. 2016-02

As discussed in Note 2 to the consolidated financial statements, the Company changed its method for accounting for leases effective May 1, 2019 due to the adoption of Accounting Standards Update (ASU) No. 2016-02,Leases (Topic 842), and the related amendments.

 

Basis for Opinion

 

These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

 

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures include examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

 

/s/ Ernst & Young LLP

 

We have served as the Company’s auditor since 1999.

 

Irvine, California

June 27, 2019

30, 2020

 

 

 

 3531 

 

AVID BIOSERVICES, INC.

CONSOLIDATED BALANCE SHEETS

(in thousands, except par value)

  April 30, 
  2020  2019 
ASSETS      
Current assets:        
Cash and cash equivalents $36,262  $32,351 
Accounts receivable  8,606   7,374 
Contract assets  3,300   4,327 
Inventory  10,883   6,557 
Prepaid expenses  712   709 
Total current assets  59,763   51,318 
Property and equipment, net  27,105   25,625 
Operating lease right-of-use assets  20,100    
Restricted cash  350   1,150 
Other assets  302   302 
Total assets $107,620  $78,395 
         
LIABILITIES AND STOCKHOLDERS’ EQUITY        
Current liabilities:        
Accounts payable $5,926  $4,352 
Accrued payroll and related costs  3,019   3,540 
Note payable  4,379    
Contract liabilities  29,120   14,651 
Operating lease liabilities  1,228    
Other current liabilities  808   619 
Total current liabilities  44,480   23,162 
Operating lease liabilities, less current portion  21,244    
Deferred rent, less current portion     2,072 
Other long-term liabilities     93 
Total liabilities  65,724   25,327 
         
Commitments and contingencies (Note 9)        
         
Stockholders’ equity:        
Preferred stock, $0.001 par value; 5,000 shares authorized; 1,648 shares issued and outstanding at respective dates  2   2 
Common stock, $0.001 par value; 150,000 shares authorized; 56,483 and 56,135 shares issued and outstanding at respective dates  56   56 
Additional paid-in capital  612,909   613,615 
Accumulated deficit  (571,071)  (560,605)
Total stockholders’ equity  41,896   53,068 
Total liabilities and stockholders’ equity $107,620  $78,395 

See accompanying notes to consolidated financial statements.

32

AVID BIOSERVICES, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(in thousands, except per share information)

 

  Year Ended April 30, 
  2020  2019  2018 
          
Revenues $59,702  $53,603  $53,621 
Cost of revenues  55,770   46,379   56,545 
Gross profit (loss)  3,932   7,224   (2,924)
Operating expenses:            
Selling, general and administrative  14,517   12,846   16,456 
Loss on lease termination  355       
Restructuring charges        1,258 
Total operating expenses  14,872   12,846   17,714 
             
Operating loss  (10,940)  (5,622)  (20,638)
Interest and other income, net  474   282   75 
Loss from continuing operations before income taxes $(10,466) $(5,340) $(20,563)
Income tax benefit     284    
Loss from continuing operations, net of tax  (10,466)  (5,056)  (20,563)
Income (loss) from discontinued operations, net of tax     841   (1,250)
Net loss $(10,466) $(4,215) $(21,813)
             
Comprehensive loss $(10,466) $(4,215) $(21,813)
             
Series E preferred stock accumulated dividends  (4,686)  (4,686)  (4,686)
             
Net loss attributable to common stockholders $(15,152) $(8,901) $(26,499)
             
Basic and diluted net (loss) income per common share attributable to common stockholders:            
Continuing operations $(0.27) $(0.17) $(0.53)
Discontinued operations $  $0.01  $(0.03)
Net loss per share attributable to common stockholders $(0.27) $(0.16) $(0.56)
             
Weighted average basic and diluted shares outstanding  56,326   55,981   47,063 

See accompanying notes to consolidated financial statements.

  April 30, 
  2019  2018 
ASSETS      
Current assets:        
Cash and cash equivalents $32,351  $42,265 
Accounts receivable  7,374   3,754 
Contract assets  4,327    
Inventories  6,557   16,129 
Prepaid expenses  709   679 
Assets of discontinued operations     5,000 
         
Total current assets  51,318   67,827 
         
Property and equipment, net  25,625   26,479 
Restricted cash  1,150   1,150 
Other assets  302   304 
         
Total assets $78,395  $95,760 
         
LIABILITIES AND STOCKHOLDERS' EQUITY        
Current liabilities:        
Accounts payable $4,352  $1,909 
Accrued payroll and related costs  3,540   2,564 
Contract liabilities  14,651   27,935 
Other current liabilities  619   905 
Liabilities of discontinued operations     4,550 
         
Total current liabilities  23,162   37,863 
         
Deferred rent, less current portion  2,072   2,159 
Capital lease, less current portion  93    
         
Commitments and contingencies (Note 8)        
         
Stockholders' equity:        
Preferred stock, $0.001 par value; 5,000,000 shares authorized; 1,647,760 shares issued and outstanding at respective dates  2   2 
Common stock, $0.001 par value; 150,000,000 shares authorized; 56,135,697 and 55,689,222 shares issued and outstanding at respective dates  56   55 
Additional paid-in-capital  613,615   614,810 
Accumulated deficit  (560,605)  (559,129)
         
Total stockholders' equity  53,068   55,738 
         
Total liabilities and stockholders' equity $78,395  $95,760 
33

AVID BIOSERVICES, INC.

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(in thousands, except per share information)

  Preferred Stock  Common Stock  Additional Paid-In  Accumulated  Total Stockholders' 
  Shares  Amount  Shares  Amount  Capital  Deficit  Equity 
Balances at April 30, 2017  1,648  $2   44,014  $44  $590,971  $(537,435) $53,582 
Series E preferred stock dividends paid
($2.625 per share)
              (4,325)     (4,325)
Cumulative-effect adjustment to accumulated deficit pursuant to adoption of ASU 2016-09              (119)  119    
Common stock issued, net of issuance costs of $111        1,051   1   4,192      4,193 
Common stock issued, net of issuance costs of $1,669        10,295   10   21,484      21,494 
Common stock issued under Employee Stock Purchase Plan        88      317      317 
Fractional shares issued pursuant to reverse stock split        19              
Exercise of stock options        222      752      752 
Stock-based compensation expense              1,538      1,538 
Net loss                 (21,813)  (21,813)
Balances at April 30, 2018  1,648   2   55,689   55   614,810   (559,129)  55,738 
Series E preferred stock dividends paid
($2.625 per share)
              (4,325)     (4,325)
Cumulative-effect adjustment to accumulated deficit pursuant to adoption of ASC 606                 2,739   2,739 
Common stock issued under Employee Stock Purchase Plan        75      258      258 
Exercise of stock options        371   1   1,277      1,278 
Stock-based compensation expense              1,595      1,595 
Net loss                 (4,215)  (4,215)
Balances at April 30, 2019  1,648   2   56,135   56   613,615   (560,605)  53,068 
Series E preferred stock dividends paid
($2.625 per share)
              (4,325)     (4,325)
Common stock issued under Employee Stock Purchase Plan        48      187      187 
Exercise of stock options        251      933      933 
Vesting of restricted stock units        49             
Stock-based compensation expense              2,499      2,499 
Net loss                 (10,466)  (10,466)
Balances at April 30, 2020  1,648  $2   56,483  $56  $612,909  $(571,071) $41,896 

 

See accompanying notes to consolidated financial statements.

 

 

 

 3634 

 

AVID BIOSERVICES, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSSCASH FLOWS

(in thousands, except share and per share information)thousands)

 

  Year Ended April 30, 
  2019  2018  2017 
          
Revenues $53,603  $53,621  $57,630 
Cost of revenues  46,379   56,545   38,259 
Gross profit (loss)  7,224   (2,924)  19,371 
             
Operating expenses:            
Selling, general and administrative  12,846   16,456   18,079 
Restructuring charges     1,258    
             
Total operating expenses  12,846   17,714   18,079 
             
Operating (loss) income  (5,622)  (20,638)  1,292 
Interest and other income, net  282   75   101 
             
(Loss) income from continuing operations before income taxes $(5,340) $(20,563) $1,393 
Income tax benefit  284       
(Loss) income from continuing operations  (5,056)  (20,563)  1,393 
Income (loss) from discontinued operations, net of tax  841   (1,250)  (29,552)
Net loss $(4,215) $(21,813) $(28,159)
             
Comprehensive loss $(4,215) $(21,813) $(28,159)
             
Series E preferred stock accumulated dividends  (4,686)  (4,686)  (4,640)
             
Net loss attributable to common stockholders $(8,901) $(26,499) $(32,799)
             
Basic and diluted net (loss) income per common share attributable to common stockholders:            
Continuing operations $(0.17) $(0.53) $(0.09)
Discontinued operations $0.01  $(0.03) $(0.79)
Net loss per share attributable to common stockholders $(0.16) $(0.56) $(0.88)
             
Weighted average basic and diluted shares outstanding  55,981,060   47,063,020   37,109,493 

  Year Ended April 30, 
  2020  2019  2018 
CASH FLOWS FROM OPERATING ACTIVITIES:            
Net loss $(10,466) $(4,215) $(21,813)
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:            
Depreciation and amortization  3,091   2,746   2,562 
Stock-based compensation  2,499   1,595   1,538 
Loss on disposal of assets  13   127   1,692 
Gain on sale of research and development assets     (1,000)  (8,000)
Changes in operating assets and liabilities:            
Accounts receivable  (1,232)  (3,620)  3,988 
Contract assets  1,027   (1,439)   
Inventory  (4,326)  1,701   16,970 
Prepaid expenses and other assets  (3)  (28)  153 
Accounts payable  802   2,125   (1,271)
Accrued payroll and related costs  (521)  976   (2,491)
Contract liabilities  14,469   (5,371)  (17,582)
Other accrued expenses and other liabilities  474   (642)  1,009 
Assets and liabilities of discontinued operations     (4,550)  (2,747)
Net cash provided by (used in) operating activities  5,827   (11,595)  (25,992)
             
CASH FLOWS FROM INVESTING ACTIVITIES:            
Purchase of property and equipment  (3,812)  (1,502)  (3,793)
Proceeds from sale of property and equipment     46    
Proceeds from sale of research and development assets     6,000   3,000 
Net cash (used in) provided by investing activities  (3,812)  4,544   (793)
             
CASH FLOWS FROM FINANCING ACTIVITIES:            
Proceeds from issuance of common stock, net of issuance costs        25,687 
Proceeds from exercise of stock options  933   1,278   752 
Proceeds from issuance of common stock under employee stock purchase plan  187   258   317 
Proceeds from note payable  4,379       
Dividends paid on preferred stock  (4,325)  (4,325)  (4,325)
Principal payments on finance lease  (78)  (74)  (180)
Net cash provided by (used in) financing activities  1,096   (2,863)  22,251 
             
Net increase (decrease) in cash, cash equivalents and restricted cash $3,111  $(9,914) $(4,534)
Cash, cash equivalents and restricted cash, beginning of period  33,501   43,415   47,949 
Cash, cash equivalents and restricted cash, end of period $36,612  $33,501  $43,415 
             
Supplemental disclosures of cash flow information:            
Interest paid $8  $11  $4 
             
Supplemental disclosure of non-cash activities:            
Decapitalization of right-of-use assets upon lease termination and/or modification $1,469  $  $ 
Unpaid purchases of property and equipment $772  $318  $180 
Property and equipment acquired under finance lease $  $245  $ 
Receivable related to the sale of research and development assets $  $  $5,000 

 

See accompanying notes to consolidated financial statements.

 

 

 

 3735 

 

AVID BIOSERVICES, INC.

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(in thousands, except share information)

  Preferred Stock  Common Stock  Additional Paid-In  Accumulated  Total Stockholders’ 
  Shares  Amount  Shares  Amount  Capital Deficit Equity 
BALANCES, April 30, 2016  1,577,440  $2   33,847,213  $34  $559,314  $(509,276) $50,074 
Series E preferred stock issued, net of issuance costs of $58  70,320            1,576      1,576 
Series E preferred stock dividends paid              (4,279)     (4,279)
Common stock issued, net of issuance costs of $487        6,137,403   6   17,753      17,759 
Common stock issued, net of issuance costs of $340        3,750,323   4   12,687      12,691 
Common stock issued under Employee Stock Purchase Plan        270,075      526      526 
Exercise of stock options        9,026      31      31 
Stock-based compensation expense              3,363      3,363 
Net loss                 (28,159)  (28,159)
BALANCES, April 30, 2017  1,647,760   2   44,014,040   44   590,971   (537,435)  53,582 
Series E preferred stock dividends paid              (4,325)     (4,325)
Cumulative-effect adjustment to accumulated deficit pursuant to adoption of ASU 2016-09              (119)  119    
Common stock issued, net of issuance costs of $111        1,051,259   1   4,192      4,193 
Common stock issued, net of issuance costs of $1,669        10,294,445   10   21,484      21,494 
Common stock issued under Employee Stock Purchase Plan        88,327      317      317 
Exercise of stock options        222,255      752      752 
Fractional shares issued pursuant to reverse stock split        18,896              
Stock-based compensation expense              1,538      1,538 
Net loss                 (21,813)  (21,813)
BALANCES, April 30, 2018  1,647,760   2   55,689,222   55   614,810   (559,129)  55,738 
Series E preferred stock dividends paid              (4,325)     (4,325)
Cumulative-effect adjustment to accumulated deficit pursuant to adoption of ASC 606 (Note 2)                 2,739   2,739 
Common stock issued under Employee Stock Purchase Plan        75,148      258      258 
Exercise of stock options        371,327   1   1,277      1,278 
Stock-based compensation expense              1,595      1,595 
Net loss                 (4,215)  (4,215)
BALANCES, April 30, 2019  1,647,760  $2   56,135,697  $56  $613,615  $(560,605) $53,068 

See accompanying notes to consolidated financial statements.

38

AVID BIOSERVICES, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

  Year Ended April 30, 
  2019  2018  2017 
CASH FLOWS FROM OPERATING ACTIVITIES:            
Net loss $(4,215) $(21,813) $(28,159)
Adjustments to reconcile net loss to net cash used in operating activities:            
Depreciation and amortization  2,746   2,562   2,463 
Stock-based compensation  1,595   1,538   3,363 
Loss on disposal of assets  127   1,692   1 
Gain on sale of research and development assets  (1,000)  (8,000)   
Changes in operating assets and liabilities:            
Accounts receivable  (3,620)  3,988   (4,883)
Contract assets  (1,439)      
Inventories  1,701   16,970   (16,913)
Prepaid expenses and other assets  (28)  153   434 
Accounts payable  2,125   (1,271)  (3,804)
Accrued payroll and related costs  976   (2,491)  372 
Contract liabilities  (5,371)  (17,582)  11,275 
Other accrued expenses and other liabilities  (642)  1,009   (407)
Assets and liabilities of discontinued operations  (4,550)  (2,747)  (2,911)
Net cash used in operating activities  (11,595)  (25,992)  (39,169)
             
CASH FLOWS FROM INVESTING ACTIVITIES:            
Purchase of property and equipment  (1,502)  (3,793)  (3,627)
Decrease in other assets        568 
Proceeds from sale of property and equipment  46       
Proceeds from sale of research and development assets  6,000   3,000    
Net cash provided by (used in) investing activities  4,544   (793)  (3,059)
             
CASH FLOWS FROM FINANCING ACTIVITIES:            
Proceeds from issuance of common stock, net of issuance costs     25,687   30,450 
Proceeds from issuance of preferred stock, net of issuance costs        1,576 
Proceeds from issuance of common stock under employee stock purchase plan  258   317   526 
Proceeds from exercise of stock options  1,278   752   31 
Dividends paid on preferred stock  (4,325)  (4,325)  (4,279)
Principal payments on capital lease  (74)  (180)  (139)
Net cash (used in) provided by financing activities  (2,863)  22,251   28,165 
             
Change in cash, cash equivalents and restricted cash $(9,914) $(4,534) $(14,063)
Cash, cash equivalents and restricted cash, beginning of period  43,415   47,949   62,012 
Cash, cash equivalents and restricted cash, end of period $33,501  $43,415  $47,949 
             
Cash and cash equivalents, end of period  32,351   42,265   46,799 
Restricted cash, end of period  1,150   1,150   1,150 
Cash, cash equivalents and restricted cash, end of period $33,501  $43,415  $47,949 
             
Supplemental disclosures of cash flow information            
Interest paid $11  $4  $6 
             
Supplemental disclosure of non-cash activities            
Unpaid purchases of property and equipment $318  $180  $658 
Property and equipment acquired under capital lease $245  $  $319 
Receivable related to the sale of research and development assets $  $5,000  $ 

See accompanying notes to consolidated financial statements.

39

avid bioservices, inc.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(in thousands, except share and per share information)

 

 

Note 1 – Description of Company and Basis of Presentation

 

We are a dedicated contract development and manufacturing organization (“CDMO”) that provides a comprehensive range of services from process development to Current Good Manufacturing Practices (“CGMP”) clinical and commercial manufacturing, focused on biopharmaceutical productsdrug substances derived from mammalian cell culture for biotechnology and pharmaceutical companies.

 

Effective January 5, 2018, we changed our name to Avid Bioservices, Inc. from Peregrine Pharmaceuticals, Inc. in connection with our transition to a dedicated CDMO and the discontinuation of our research and development activities. Except where specifically noted orFor the context otherwise requires, references to “Avid,” “the Company,” “we,” “us,”fiscal 2019 and “our,” in this Annual Report refer to Avid Bioservices, Inc. and its subsidiaries.

Basis of Presentation and Preparation

The accompanying consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) and include the accounts of Avid Bioservices, Inc. and its subsidiaries. All intercompany accounts and transactions among the consolidated entities have been eliminated in the consolidated financial statements. The preparation of our financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ materially from these estimates.

The financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. At April 30, 2019, we had $32,351 in cash and cash equivalents. Our ability to fund our operations is dependent on the amount of cash on hand and our ability to generate positive cash flow to sustain our current operations. We have expended substantial funds on our contract manufacturing business and, historically, on our legacy 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 expect negative cash flows from operations to continue until we can generate sufficient revenue to generate positive cash flow from operations. We plan to fund our operations using our existing cash and cash equivalents and cash generated from services provided under our customer contracts. In the event we are unable to secure sufficient business to support our current operations, we may need to raise additional capital in the future. There can be no assurance that equity financing will be available on acceptable terms or at all. Our ability to raise additional capital in the equity markets to fund our future operations 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 and economic and market conditions. If we are unable to fund our continuing operations through these sources 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. Any of these actions could materially harm our business, results of operations, and future prospects. Further, we performed an analysis and concluded that based on our cash and cash equivalents as of April 30, 2019 in conjunction with cash generated from services provided under our customer contracts will provide us with adequate cash on hand to support our operations for at least one year from the date that our consolidated financial statements are issued.

Certain prior year amounts related to deferred revenue and customer deposits have been reclassified to contract liabilities to conform to the current period’s presentation. This reclassification had no effect on previously reported net loss.

Discontinued Operations

For all2018 periods presented, the operating results of our former research and development segment have been excluded from continuing operations and reported as income (loss) from discontinued operations, net of tax, in the accompanying consolidated financial statements. In addition, the assetsConsolidated Statements of Operations and liabilities related to our discontinued research and development segment are reported as assets and liabilities of discontinued operations in the accompanying Consolidated Balance Sheet at April 30, 2018.Comprehensive Loss. For additional information on the discontinuation of our research and development segment, refer to Note 10, “Sale11,Sale of Research and Development Assets”Assets. Except where specifically noted or the context otherwise requires, references to “Avid,” the “Company,” “we,” “us,” and “our,” in this Annual Report refer to Avid Bioservices, Inc. and its subsidiaries.

Basis of Presentation and Preparation

The accompanying consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) and include the accounts of Avid Bioservices, Inc. and our subsidiaries. All intercompany accounts and transactions among the consolidated entities have been eliminated in the consolidated financial statements. The preparation of our consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Management’s estimates are based on historical information available as of the date of the consolidated financial statements and on various other assumptions that are believed to be reasonable under the circumstances. Accounting estimates and judgements are inherently uncertain and actual results could differ materially from these estimates.

 

Segment Reporting

 

Our business had historically been organized into two reportable operating segments: (i) contract manufacturing services and (ii) research and development. However, as a result of the aforementioned discontinuation of our research and development segment,management has determined that the Company operates in only one operating segment. Accordingly, we reported our financial results for one reportable segment.

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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

( All of our identifiable assets are in thousands, except share and per share information)the United States.

 

Note 2 – Summary of Significant Accounting Policies

 

Cash and Cash Equivalents

 

We consider all short-term investments readily convertible to cash, without notice or penalty, with an initial maturity of 90 days or less to be cash equivalents.

 

Restricted Cash

 

Under the terms of three separate operating leases related to our facilities (Note 4), we are required to maintain,pledged, as collateral, letters of credit duringcredit. During the terms of such leases (Note 3). Atfiscal year ended April 30, 2019 and 2018,2020, an aggregate amount of $0.8 million of restricted cash of $1,150that was pledged as collateral under thesetwo such letters of credit was released back to us. Accordingly, at April 30, 2020 and 2019, restricted cash of $0.4 million and $1.2 million, respectively, was pledged as collateral under letters of credit.

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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the Consolidated Balance Sheets that sum to the total of the same amounts shown in the Consolidated Statements of Cash Flows (in thousands):

  As of April 30, 
  2020  2019  2018 
Cash and cash equivalents $36,262  $32,351  $42,265 
Restricted cash  350   1,150   1,150 
Total cash, cash equivalents and restricted cash $36,612  $33,501  $43,415 

 

Revenue Recognition

 

We deriveOn May 1, 2018, we adopted Accounting Standards Update (“ASU”) No. 2014-09,Revenue from Contracts with Customers (Topic 606), and its subsequent updates (codified as “ASC 606”), to all contracts that had not been completed as of May 1, 2018 using the modified retrospective method. Accordingly, results for reporting periods after May 1, 2018 are presented in accordance with ASC 606, while prior period amounts have not been adjusted and continue to be reported under the accounting standards that were in effect prior to our adoption of ASC 606. The cumulative effect of adopting ASC 606 resulted in a one-time adjustment of $2.7 million to the opening balance of accumulated deficit as of May 1, 2018 which is reflected in the Consolidated Statements of Stockholders’ Equity for the fiscal year ended April 30, 2019.

Under ASC 606, we recognize revenue when we transfer promised goods or services to customers in an amount that reflects the consideration to which we expect to be entitled in exchange for those goods or services. To determine revenue recognition for contracts with customers, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy a performance obligation.

Revenue recognized from contract manufacturing services provided under our customer contracts which we haveare disaggregated into the followingmanufacturing and process development revenue streams:streams.

 

Manufacturing revenue

 

The manufacturingManufacturing revenue stream generally represents revenue from the manufacturing of customer product(s) derived from mammalian cell culture covering clinical through commercial manufacturing runs.products 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 manufacturing contract, a quantity of manufacturing runs areis ordered and the product is manufactured according to the customer’s specifications and typically only one performance obligation is included. Each manufacturing run represents a distinct service that is sold separately and has stand-alone value to the customer. The product(s)products are manufactured exclusively for a specific customer and have no alternative use. The customer retains control of theirits product during the entire manufacturing process and can make changes to the process or specifications at theirits request. Under these agreements, we are entitled to consideration for progress to date that includes an element of profit margin. Revenue

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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

Process development revenue

Process development revenue generally represents revenue from services associated with this streamthe 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.

Process development revenue

The process development revenue stream generally represents revenue from non-manufacturing related services associated with the custom development of a manufacturing process and analytical methods for a customer’s product. 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 theirits specifications and typically only one performance obligation is included. Each process represents a distinct service that is sold separately and has stand-alone value to the customer. The customer also retains control of theirits product as the product is being created or enhanced by our services and can make changes to theirits process or specifications upon request. Revenue associated with this stream is recognized over time utilizing an input method that compares the cost of cumulative work-in-processUnder these agreements, we are entitled to consideration for progress to date to the most current estimates for the entire costthat includes an element of the performance obligation.

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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(in thousands, except share and per share information)

profit margin.

 

The following table disaggregatessummarizes our manufacturing and process development revenue for the fiscal years ended April 30, 2020, 2019 and 2018 and 2017 by revenue stream.

  Fiscal Year Ended April 30, 
  2019  2018  2017 
Manufacturing revenue $43,432  $47,437  $52,215 
Process development revenue  10,171   6,184   5,415 
Total Revenues $53,603  $53,621  $57,630 

Revenues(in thousands). Revenue for the fiscal yearsyear ended April 30, 2018 and 2017 havehas not been adjusted in accordance with our modified retrospective adoption of Accounting Standards Concepts (“ASC”)ASC 606 Revenue from Contracts with Customers (“ASC 606”) as of May 1, 2018, and continues to be reported under the accounting standards that were in effect prior to our adoption of ASC 606 as further discussed below under the section, “Accounting Standards Adopted in Fiscal Year 2019”.606:

 

  Fiscal Year Ended April 30, 
  2020  2019  2018 
Manufacturing revenues $52,046  $43,432  $47,437 
Process development revenues  7,656   10,171   6,184 
  Total Revenues $59,702  $53,603  $53,621 

The timing of revenue recognition, billings and cash collections results in billed trade receivables,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 trade receivablesaccounts receivable on the consolidated 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.

 

Payment terms can vary by the type of contract manufacturing services offered, however, the term between invoicing and when payment is due is not significant. For certain services, payment prior to satisfaction of a performance obligation can be required, and results in recording a contract liability.

During the fiscal yearyears ended April 30, 2020 and 2019, we recognized revenue of $14,312$13.6 million and $14.3 million, respectively, for which the contract liability was recorded in a prior period.

The transaction price for services provided under our customer contracts reflect our best estimates of the prior year.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.

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, 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.

 

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. In addition,As of April 30, 2020, we currently do not have any unsatisfied performance obligations for contracts greater than one year.

 

Prior to the adoption of ASC 606 on May 1, 2018, revenue was generally recognized when all of the following criteria were met: (i) persuasive evidence of 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.

Costs incurred to obtain a contract are not material. These costs are generally employee sales commissions, which are expensed when incurred and included in selling, general and administrative expense in the accompanying consolidated statements of operations and comprehensive loss.

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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

Accounts Receivable

 

Accounts receivable generally represent trade amounts billed for contract manufacturing and process development services provided under our customer contracts and are recorded at the invoiced amount net of an allowance for doubtful accounts, if necessary. Accounts receivable consisted of the following:

  April 30, 
  2019  2018 
Trade receivables $7,374  $3,539 
Other receivables     215 
Total Accounts receivable $7,374  $3,754 

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,our receivables, historical experience, and the financial condition of our customers. Based on our analysis of our receivablesaccounts receivable balances as of April 30, 20192020 and 2018,2019, we determined no allowance for doubtful accounts was necessary.

 

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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(in thousands, except share and per share information)

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, trade receivablesaccounts receivable and contract assets. 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 consolidated balance sheet.Consolidated Balance Sheets exceed the amount of government insurance limits provided on our deposits.

 

Our trade receivablesaccounts receivable from amounts billed for contract manufacturing and process development services have historically beenare 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 April 30, 2020 and 2019, approximately 98% and 2018, approximately 95% and 93%, respectively, of our trade receivablesaccounts receivable were due from six customers. Our contract assets are reclassified to trade receivablesaccounts receivable when our rights to consideration become unconditional. At April 30, 2020 and 2019, approximately 96% and 87% of our contract assets were attributable to six customers and eight customers.customers, respectively.

 

Our revenues have historically beenare 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 a 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 a commercial product.

 

The percentagestable below represent revenues derived fromidentifies each customer as a percentage of our customers that accounted for 10% or more of our total revenues during any of the fiscal years ended April 30, 2020, 2019 2018 and 2017:2018:

 

Customer Geographic Location  2019   2018   2017  

Geographc

Location

  2020  2019  2018 
Halozyme Therapeutics, Inc. U.S.  30%   55%   58%   U.S.       28%      30%      55% 
Gilead Sciences, Inc.  U.S.   24       
Acumen Pharmaceuticals, Inc.  U.S.   11   *    
IGM Biosciences, Inc.  U.S.   11   *    
Coherus BioSciences, Inc.  U.S.   10   13   22 
ADC Therapeutics America Inc. U.S.  21      9      –      U.S.   *   21   * 
Coherus BioSciences, Inc. U.S.  13      22      26   
 
Other customers U.S./non-U.S.  36      14      16    
Total   100%   100%   100% 

______________

*         Represents a percentage less than 10% of our total revenues.

 

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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

We attribute revenue to the individual countries where the customer is headquartered. Revenues derived from U.S. based customers were 95%99%, 99%95% and 100%99% for the fiscal years ended April 30, 2020, 2019 2018 and 2017,2018, respectively.

 

InventoriesInventory

 

Inventories areInventory consists of raw materials inventory and is valued at the lower of cost, or net realizable value, determined by the first-in, first-out method. Subsequent to the adoption of ASC 606 (Note 2), manufacturing costs associated with work-in-process inventory (comprised of raw materials, direct labor and overhead costs associated with in-process manufacturing services) are recorded to cost of revenues in the accompanying consolidated financial statements as incurred. Overhead costs allocated to work-in-process inventory are based on the normal capacity of our production facilities and do not include costs from under absorption of overhead costsmethod, or idle capacity, which are expensed directly to cost of revenues in the period incurred. Inventories consist of the following:

  April 30, 
  2019  2018 
Raw materials $6,557  $8,165 
Work-in-process     7,964 
Total Inventories $6,557  $16,129 

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 determineddeemed necessary.

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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(in thousands, except share and per share information)

 

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 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. as follows:

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

Construction-in-progress, which represents direct costs related to the construction of various equipment and leasehold improvements primarily associated with our manufacturing facilities, areis not depreciated until the asset is completed and placed into service. No interest was incurred or capitalized as construction-in-progress as of April 30, 20192020 and 2018.2019. All of our property and equipment are located in the U.S. Property and equipment consist of the following:following (in thousands):

 

 April 30,  April 30, 
 2019  2018  2020  2019 
Leasehold improvements $20,574  $20,686  $21,130  $20,574 
Laboratory and manufacturing equipment  12,858   10,258   15,033   12,858 
Computer equipment and software  4,644   4,087   5,334   4,644 
Furniture, fixtures and office equipment  528   510   685   528 
Construction-in-progress  1,590   3,310   2,564   1,590 
Total Property and equipment, gross  40,194   38,851 
Less: Accumulated depreciation and amortization  (14,569)  (12,372)
Total Property and equipment, net $25,625  $26,479 
Total property and equipment, gross  44,746   40,194 
Less: accumulated depreciation and amortization  (17,641)  (14,569)
Total property and equipment, net $27,105  $25,625 

 

Depreciation and amortization expense for the years ended April 30, 2020, 2019 and 2018 was $3.1 million, $2.7 million and 2017 was $2,746, $2,562 and $2,463,$2.6 million, respectively.

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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

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 that indicate that their carrying value may not be recoverable. Long-lived assets are reported at the lower of carrying amount or fair value less cost to sell.sell if impairment indicators exist. For the fiscal years ended April 30, 20192020 and 2018,2019, there were no indicators of impairment of the value of our long-lived assets.assets and no cumulative impairment losses recognized as of April 30, 2020.

 

Fair Value of Financial Instruments

 

The carrying amounts in the accompanying Consolidated Balance Sheets for cash and cash equivalents, restricted cash, accounts receivable, accounts payable, and accrued liabilities and note payable approximate their fair values due to their short-term maturities.

 

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 April 30, 20192020 and 2018,2019, we do not have any Level 2 or Level 3 financial assets or liabilities and our cash equivalents, which are primarily invested in money market funds with one major commercial bank, are carried at fair value based on quoted market prices for identical securities (Level 1 input)inputs). In addition, there were no transfers between any Levels of the fair value hierarchy during the fiscal years ended April 30, 20192020 and 2018.

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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(in thousands, except share and per share information)

Deferred Rent

Rent expense is recorded on a straight-line basis over the initial term of our operating lease agreements and the difference between rent expense and the amounts paid is recorded as a deferred rent liability. Incentives granted under our operating leases, including tenant improvements and landlord-funded lease incentives, are recorded as a deferred rent liability, which is amortized as a reduction to rent expense over the term of the operating lease (Note 3).2019.

 

Restructuring Charges

 

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 and completed during the fiscal year ended April 30, 2018 (Note 9)10). One-time termination benefits were expensed at the date we notified the employee, unless the employee was required to provide future service, in which case the benefits were expensed ratably over the future service period.

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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

Stock-Based Compensation

 

We account for stock options, restricted stock units and other stock-based awards granted under our equity compensation plans in accordance with the authoritative guidance for stock-based 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 is measured at the grant date based on the closing market price of our common stock on the date of grant, and is recognized as expense on a straight-line basis over the period of vesting. Forfeitures are recognized as a reduction of stock-based compensation expense as they occur. As of April 30, 2020 and 2019, there were no outstanding stock-based awards with market or performance conditions.

 

Income Taxes

 

We utilize the liability method of accounting for income taxes in accordance with ASCAccounting Standards Codification (“ASC”) 740:Income Taxes (“ASC 740”). Under the liability method, deferred taxes are determined based on the differences between the financial reporting and tax bases of assets and liabilities and are measured using enacted tax rates in effect for the year in which those temporary differences are expected to be recovered or settled. A valuation allowance is provided for the amount of deferred tax assets that, based on available evidence, are not expected to be realized (Note 6)7). In addition, we recognize the impact of an uncertain tax position only when it is more likely than not the tax position will be sustained upon examination by the tax authorities. We are required to file federal state and foreignstate income tax returns in various jurisdictions. The preparation of these returns requires us to interpret the applicable tax laws in effect in such jurisdictions, which could affect the amount paid by usus.

 

The income tax benefit recognized in the accompanying Consolidated Statements of Operations and Comprehensive Loss for the year ended April 30, 2019 resulted from the “Intraperiod Tax Allocation” rules under ASC 740, which requires the allocation of an entity’s total annual income tax provision among continuing operations and, in our case, discontinued operations. Accordingly, a tax benefit was recorded in continuing operations with an offsetting tax expense recorded in discontinued operations (Note 10)11).

 

Comprehensive Loss

 

Comprehensive loss is 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.

 

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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(in thousands, except share and per share information)

Recently Adopted Accounting Standards Adopted in Fiscal Year 2019

 

In May 2014,February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers (Topic 606) (codified as ASC 606), which, along with subsequent amendments issued after May 2014, replaced substantially all the relevant U.S. GAAP revenue recognition guidance. ASC 606, as amended, is based on the principle that revenue is recognized to depict the contractual 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, which steps include (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation.

On May 1, 2018, we adopted ASC 606, as amended, to all contracts that had not been completed as of May 1, 2018 using the modified retrospective method. Accordingly, results for the reporting period beginning after May 1, 2018 are presented in accordance with ASC 606, while prior period amounts have not been adjusted and continue to be reported under the accounting standards that were in effect for the prior periods.

The cumulative effect of adopting ASC 606 resulted in a one-time adjustment of $2,739 to the opening balance of accumulated deficit which is reflected in the accompanying Consolidated Statements of Stockholders’ Equity for the fiscal year ended April 30, 2019. The cumulative effect adjustment relates to the recognition of revenue and related costs for customer contracts that transfer goods or services over time. Under ASC 606, the timing of the recognition of revenue and the related cost of revenue associated with goods or services provided to customers with no alternative use are 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. By contrast, in the prior periods, revenue and the related costs were recognized upon completion of the performance obligation in accordance with accounting standards that were in effect in the prior periods. Under these customer contracts the customer retains control of the product as it is being created or enhanced by our services and/or we are entitled to compensation for progress to date that includes an element of profit margin.

The cumulative effect of the adoption of ASC 606 on amounts previously reported on the Consolidated Balance Sheet at April 30, 2018 was as follows:

  

 

As

Reported

April 30, 2018

  

 

ASC 606

Transition Adjustment

  

 

 

Balance at

May 1, 2018

 
          
Contract assets $  $2,888  $2,888 
Inventories  16,129   (7,871)  8,258 
Contract liabilities  27,935   (7,913)  20,022 
Other current liabilities  905   191   1,096 
Accumulated deficit  (559,129)  2,739   (556,390)

The impact of the adoption of ASC 606 on the Consolidated Balance Sheet at April 30, 2019 was as follows:

  

As

Reported

  

Effect of Adoption

Increase/(Decrease)

  Balance Without Adoption of ASC 606 
Contract assets $4,327  $4,327  $ 
Inventories  6,557   (18,293)  24,850 
Contract liabilities  14,651   (19,771)  34,422 

The impact of the adoption of ASC 606 on the Consolidated Statements of Operations and Comprehensive Loss for the fiscal year ended April 30, 2019 was as follows:

  

As

Reported

  

Effect of Adoption

Increase/(Decrease)

  Balance Without Adoption of ASC 606 
Revenues $53,603  $13,243  $40,360 
Cost of revenues  46,379   9,743   36,636 
Gross profit  7,224   3,500   3,724 
Operating loss  (5,622)  3,500   (9,122)
Loss from continuing operations  (5,056)  3,500   (8,556)

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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(in thousands, except share and per share information)

In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows (Topic 230):Restricted Cash, which clarifies the presentation requirements of restricted cash within 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. We adopted ASU 2016-18 on May 1, 2018 and the cash and cash equivalents at the beginning-of-period and end-of-period total amounts in our consolidated statements of cash flows have been adjusted to include restricted cash for each of the periods presented.

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 stock-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. We adopted ASU 2017-09 on May 1, 2018. The adoption of this ASU did not have a material impact on our consolidated financial statements and related disclosures.

New Accounting Standards Not Yet Adopted

In February 2016, the FASB issued ASUNo. 2016-02 Leases and its related amendments (collectively referred to as Topicwhich introducedLeases (Topic 842) (codified as “ASC(“ASC 842”), a new comprehensive lease accounting model that superseded the lease guidance underLeases (Topic 840). The new accounting standard requires lessees to recognize right-of-use assets and corresponding lease liabilities for all leases with durationslease terms of greater than 12 months onmonths. It also changed the balance sheet as well as provide disclosures with respectdefinition of a lease and expanded the disclosure requirements of lease arrangements. In July 2018, the FASB added a transition option for implementation that allowed companies to certain qualitative and quantitative information regardingcontinue to use the amount, timing and uncertaintylegacy guidance in ASC 840,Leases, including its disclosure requirements, in the comparative periods presented in the year of cash flows arising from leases. The right-of-use assets and lease liabilities will initially be measured at the present value of the future minimum lease payments over the lease term. Subsequent measurement, including the presentation of expenses and cash flows, will depend on the classification of the lease as either a finance lease or an operating lease. ASC 842 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.adoption.

 

42

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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

On May 1, 2019, we adopted ASC 842 using the modified retrospective approach. Accordingly, prior period financial information and disclosures have not been adjusted and continue to be reported in accordance with our historical accounting under the previous lease standard. In addition, we elected the optional transition method to apply the standard as of the effective date and therefore, we will not apply the standard to the comparative periods presented in the consolidated financial statements. We have elected the transition package of three practical expedients permitted within the standard,available for existing contracts, which eliminates the requirementsallowed us to reassess prior conclusions aboutcarry forward our historical assessments of lease identification, lease classification, and initial direct costs. Further, we have electedAs a short-term lease exception policy, permitting us to not apply the recognition requirementsresult of this standard to short-term leases (i.e., leases with terms of 12 months or less) and an accounting policy to account for lease and non-lease components as a single component for certain classes of assets. While we are finalizing our evaluation of the impact of the adoption ofadopting ASC 842, on our consolidated financial statements and related disclosures, we expect to recognize on our balance sheetrecognized right-of-use assets ranging from $22,000 to $25,000, in aggregate, and lease liabilities ranging from $24,000 to $27,000, in aggregate,of $23.3 million and $25.5 million, respectively, on May 1, 2019, which are primarily related to our facility operating leases (Note 3)4). The difference between the right-of-use assets and lease liabilities is primarily attributed to the elimination of deferred rent. The adoption of ASC 842 is also expected to impact our consolidated financial statement disclosures. We do not anticipate the adoption of ASC 842 will have a material impact to our Consolidated Statements of Operations and Comprehensive Loss or to require a cumulative-effectThere was no adjustment to the opening balance of accumulated deficit.deficit as a result of the adoption of ASC 842.

 

TheWe 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 assets, operating lease liabilities and operating lease liabilities, less current portion in our Consolidated Balance Sheet at April 30, 2020. Right-of-use 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 right-of-use 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 impactrate of adoptinginterest 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.

We elected the post-transition practical expedient to not separate lease components from non-lease components for all existing leases. We also elected a policy to not apply the recognition requirements of ASC 842 is based on our best estimates at the time of the preparation of this Annual Report. The actual impact is subject to change prior to our first quarterly filing of our fiscal year 2020. We are finalizing our implementation related to policies, processes and internal controls to comply with this guidance.for short-term leases.

 

Recently Issued Accounting Standards Not Yet Adopted

 

47

avid bioservices, inc.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(in thousands, except share and per share information)

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Instruments – Credit Losses (Topic 326):, Measurement of Credit Losses onof Financial Instruments.Instruments This(“ASU 2016-13”). The standard update requires that certain financial assets be measured at amortized cost net of an allowancechanges the methodology for estimatedmeasuring credit losses on financial instruments and the timing of when such that the net receivable represents the present value of expected cash collection. In addition, this standard update requires that certain financial assets be measured at amortized cost reflecting an allowance for estimated credit losses expected to occur over the life of the assets. The estimate of credit losses must be based on all relevant information including historical information, current conditions and reasonable and supportable forecasts that affect the collectability of the amounts.are recorded. As a smaller reporting company, ASU 2016-13 isand its subsequent updates are effective for fiscal years, and interim periods within those years beginning after December 15, 2019,2022, which will be our fiscal year 20212024 beginning May 1, 2020;2023; however, early adoption is permitted. We are currently evaluating the timing and impact of adopting ASU 2016-13this standard will have on our consolidated financial statements.

 

In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820):Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement(“ASU 2018-13”), which eliminates, adds and modifies the disclosure requirements in Topic 820 by removing certain disclosure requirements related to theof fair value hierarchy, modifying existing disclosure requirements relatedmeasurements. Entities will no longer be required to measurement uncertaintydisclose the amount of and adding new disclosure requirements, primarily surrounding Level 3 fair value measurements andreasons for transfers between Level 1 and Level 2.2 of the fair value hierarchy, but public companies will be required to disclose the range and weighted average used to develop significant unobservable inputs for Level 3 fair value measurements. ASU 2018-13 is effective for fiscal years, and interim periods within those years, beginning after December 15, 2019, which will be our fiscal year 2021 beginning May 1, 2020. Early adoption is permitted for any removed or modified disclosures. We are currently evaluating the new guidance and do not expect the adoption of ASU 2018-13this standard to have a material impact on our consolidated financial statements.

In 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 are currently evaluating the timing and impact of adopting ASU 2019-12 on our consolidated financial statements and related disclosures.

 

43

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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

Note 3 – Note Payable

On April 17, 2020, we entered into a promissory note (the “Note”) with City National Bank, the lender, evidencing an unsecured loan pursuant to the U.S. Small Business Administration (“SBA”) Paycheck Protection Program (“PPP”) of the Coronavirus Aid, Relief, and Economic Security Act of 2020 (the “CARES Act”) of approximately $4.4 million (the “PPP Loan”). We applied for and received the PPP Loan pursuant to the then published PPP qualification and certification requirements.

On April 23, 2020, the SBA, in consultation with the Department of Treasury, issued new guidance that created uncertainty regarding the qualification requirements for a PPP Loan (the “New Guidance”). In light of the New Guidance, we determined it appropriate to pay off the entire amount of the PPP Loan. Accordingly, on May 12, 2020, we paid off in full the principal and interest on the PPP Loan, resulting in the termination of the Note. The PPP Loan was scheduled to mature on April 21, 2022 and had a fixed interest rate of 1.00% per annum.

Note 4 – Leases

 

Operating Leases

 

We currently lease office, manufacturing, laboratory and warehouse space in fivefour buildings under fourthree separate non-cancellable operating lease agreements. All of our leased facilities are located in close proximity in Tustin, California, have original lease terms ranging from 7 to 12 years, contain two multi-year renewal options, and scheduled rent increases of 3% on either an annual or biennial basis. ThreeWith respect to multi-year renewal options, a multi-year renewal option was included in determining the right-of-use asset and lease liability for two of our leases, as we considered it reasonably certain that we would exercise such renewal options. In addition, two of our leases provide for periods of free rent, lessor improvements and 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. As collateralThe operating lease right-of-use assets and liabilities on our Consolidated Balance Sheet for threethe fiscal year ended April 30, 2020 primarily relate to these facility leases.

In September 2019, we terminated an operating lease for one of our leasesnon-manufacturing facilities that was primarily utilized for warehouse space. In connection with the termination of this lease, we are required to maintain lettersremoved the corresponding operating lease right-of-use asset and liability balances from our Consolidated Balance Sheet and recognized a loss of credit,$0.4 million, which in aggregate is $1,150 and is included in restricted cashloss on lease termination in the accompanying Consolidated Balance Sheets asStatements of April 30, 2019Operations and 2018.

Future minimum lease payments under our non-cancelable operating leases as of April 30, 2019 are as follows:

Fiscal Year  Total 
 2020  $3,032 
 2021   3,116 
 2022   3,193 
 2023   3,281 
 2024   2,789 
 Thereafter   8,062 
     Total  $23,473 

We record rent expense on a straight-line basis over the initial term of the lease. The difference between rent expense and the amounts paid under the operating leases is recorded as a deferred rent liability in the accompanying consolidated financial statements. Annual rent expense under facility operating lease agreements totaled $2,869, $2,935, and $2,180Comprehensive Loss for the fiscal yearsyear ended April 30, 2019, 2018, and 2017, respectively.2020. Additionally, the lease termination released $0.3 million of restricted cash that was pledged as collateral under a letter of credit required by the terminated lease.

 

Lease Costs

Certain of our 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.

 

 

 

 4844 

avid bioservices, inc.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(

The components of lease cost for the fiscal year ended April 30, 2020, were as follows (in thousands):

  April 30, 2020 
Operating lease cost $3,339 
Variable lease cost  603 
Short-term lease cost  171 
Total lease cost $4,113 

Operating lease expense under the prior lease standard was $2.9 million for each of the fiscal years ended April 30, 2019 and 2018. 

Supplemental Information

Supplemental consolidated balance sheet and other information related to our operating leases as of April 30, 2020 were as follows (in thousands, expect weighted average data):

  April 30, 2020 
Assets    
   Operating lease right-of-use assets $20,100 
Liabilities    
   Operating lease liabilities $1,228 
   Operating lease liabilities, less current portion  21,244 
Total operating lease liabilities $22,472 
Weighted average remaining lease term  10.5 years 
Weighted average discount rate  8.0% 

Cash paid for amounts included in thousands, except sharethe measurement of lease liabilities for the fiscal year ended April 30, 2020 was $3.1 million and per share information)

is included in net cash used in operating activities in our Consolidated Statements of Cash Flows.

 

 

Note 4Stockholders’ Equity

45

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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

Stockholder

Undiscounted Cash Flows

As of April 30, 2020, the maturities of our operating 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):

Fiscal Year  Total 
2021  $2,972 
2022   2,995 
2023   3,010 
2024   3,086 
2025   3,171 
Thereafter   18,767 
Total lease payments   34,001 
Less: imputed interest   (11,529)
Total operating lease liabilities  $22,472 

Note 5 – Stockholders’ Equity

Termination of Rights Agreement (Series D Preferred Stock)

 

On March 16, 2006, our Board of Directors adoptedwe entered into a Stockholder Rights Agreement with Rights Agent named therein, which agreement was subsequently amended and restated on March 16, 2016 (the(as amended, the “Rights Agreement”), that is. The Rights Agreement was designed to strengthen the ability of theour Board of Directors to protect the interests of our stockholders against potential abusive or coercive takeover tactics and to enable all stockholders to receive the full and fair value of their investment in the event that an unsolicited attempt is made to acquire Avid. The Rights Agreement is not intended to prevent an offer the Board of Directors concludes is in the best interest of Avid and its stockholders.

us. Under the Rights Agreement, theour Board of Directors declared a dividend of one preferred share purchase right (a(the “Right”) for each share of our common stock held by our stockholders of record as of the close of business on March 27, 2006. Each2006, each of which Right entitles holders of each share of our common stockentitled the holder thereof to buy seven one thousandths (7/1,000th)purchase a fraction of a share of Avid’sour Series D Participating Preferred Stock, par value $0.001 per share, at an exercisethe price of $77.00 per share, subject to adjustment.specified in the Rights Agreement. The Rights are neitherwere only exercisable nor traded separately from our common stock. The Rights will become exercisable and will detach from the common shares if a person or group acquiresacquired 15% or more of our outstanding common stock without prior approval from our Board of Directors, or announcesannounced a tender offer or exchange offer thatwhich, if consummated, would resulthave resulted in thatownership by a person or group owningof 15% or more of our commonoutstanding stock. Each Right, when exercised, entitles

46

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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

On September 23, 2019, the holder (other thanRights Agreement was further amended to accelerate the acquiring person or group) to receive our common stock (or in certain circumstances, voting securitiesscheduled expiration date of the acquiring person or group) with a valueRights Agreement from the close of twice the Rights’ exercise price upon payment of the exercise price of the Rights.

Avid will be entitled to redeem the Rights at $0.007 per Right at any time prior to a person or group achieving the 15% threshold. The Rights will expirebusiness on March 16, 2021.2021 to the close of business on September 23, 2019, and effectively terminate the Rights Agreement and the Rights granted thereunder as of such expiration date. Our Board of Directors elected to terminate the Rights Agreement and the Rights granted thereunder based on their recent evaluation of the effectiveness of, and the need for, a stockholder rights plan and consideration of current corporate governance practices and proxy advisory guidelines. In connection with the termination of the Rights Agreement, we filed a Notification of Removal from Listing and/or Registration under Section 12(b) of the Securities Exchange Act on Form 25 with the SEC on September 23, 2019, in order to withdraw the Rights from registration under Section 12(b) of the Securities Exchange Act of 1934, as amended, which deregistration was effective 90 days after the filing date.

 

Series E Preferred Stock

 

On February 12, 2014, we filed with the Secretary of State of the State of Delaware a Certificate of Designations of Rights and Preferences (the “Certificate of Designations”) to designate the 10.50% Series E Convertible Preferred Stock (the “Series E Preferred Stock”). The Certificate of Designations designated 2,000,000 shares of Series E Preferred Stock out of our 5,000,000 shares of authorized but unissued shares of preferred stock. The Series E Preferred Stock is classified as permanent equity in accordance with FASB ASC Topic 480,Distinguishing Liabilities from Equity. As of April 30, 2020 and 2019, there were 1,647,760 shares of our Series E Preferred Stock were issued and outstanding.

 

Each share of issued and outstanding Series E Preferred Stock is convertible at any time, at the option of the holder, into a number of whole shares of our common stock determined by dividing the liquidation preference of $25.00 per share Series E Preferred Stock by the then-current conversion price per share, currently $21.00 per share, rounded down to the nearest whole number. As of April 30, 2020, if all of our issued and outstanding shares of Series E Preferred Stock were converted at an initialthe conversion price of $21.00. The$21.00 per share, the holders of our Series E Preferred Stock would receive an aggregate of 1,961,619 shares of our common stock. However, because the conversion price of our Series E Preferred Stock is also subject to adjustment from time to time in accordance with the applicable provisions of our certificate of incorporation, we have reserved the maximum number of shares of our common stock that could be issued upon the conversion of our Series E Preferred Stock upon certain events constituting a change of control and a market trigger conversion, atevent, assuming our option, as definedshares 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 would be converted into 4.14 shares of our common stock, or 6,826,435 shares in the Certificate of Designations. aggregate.

The Series E Preferred Stock has no stated maturity date or mandatory redemption and is senior to all of our other securities. We may redeem the Series E Preferred Stock for cash, in whole or in part, by paying the redemption price of $25.00 per share, plus any accrued and unpaid dividends to the redemption date. Holders of the Series E Preferred Stock have no voting rights, except as defined in the Certificate of Designations.

 

Holders of our Series E Preferred Stock are 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 are payable quarterly in cash, on or about the 1stfirst day of each January, April, July, and October. The Series E Preferred Stock dividend for all issued and outstanding shares is set at $2.625 per annum per share. For each of the fiscal years ended April 30, 2020, 2019, 2018, and 2017,2018, we paid aggregate cash dividends of $4,325, $4,325, and $4,279, respectively,$4.3 million for issued and outstanding shares of our Series E Preferred Stock.

 

 

 

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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(in thousands, except share and per share information)

 

 

SalesSale of Common Stock and Series E Preferred Stock

 

During the fiscal yearyears ended April 30, 2020 and 2019, we had no offerings of our common stock or Series E Preferred Stock.stock.

 

During February 2018, we completed an underwriting public offering pursuant to which we sold 10,294,445 shares of our common stock at the public offering price of $2.25 per share. The aggregate gross proceeds we received from the public offering was $23,163,$23.2 million, before deducting underwriting discounts and commissions and other offering related expenses of $1,669.$1.7 million.

 

During the fiscal yearsyear ended April 30, 2018, and 2017, we sold an aggregate of 1,051,259 and 6,137,403 shares of our common stock respectively, pursuant to an At Market Issuance Sales Agreement (“AMI Sales Agreement)Agreement”) for aggregate gross proceeds of $4,304 and $18,246, respectively.$4.3 million. We paid a commission equal to 2.5% of the gross proceeds from the sale of our common stock pursuant to the AMI Sales Agreement.Agreement, or $0.1 million. As of April 30, 2018, we had raised the full amount of gross proceeds available to us under the AMI Sales Agreement.

 

During the fiscal year ended April 30, 2017, we sold an aggregate of 3,750,323 shares of our common stock pursuant to an Equity Distribution Agreement for aggregate gross proceeds of $13,031. We paid a commission equal to 2.5% of the gross proceeds from the sale of our common stock pursuant to the Equity Distribution Agreement. Warrants

As of April 30, 2017, we had raised the full amount of gross proceeds available to us under the Equity Distribution Agreement.

During the fiscal year ended April 30, 2017, we sold an aggregate of 70,320 shares of our Series E Preferred Stock pursuant to an At Market Issuance Sales Agreement (“Series E AMI Sales Agreement) for aggregate gross proceeds of $1,634. We paid a commission of up to 5% of the gross proceeds from the sale of our Series E Preferred Stock pursuant to the Series E AMI Sales Agreement. As of April 30, 2017, we are no longer issuing shares of our Series E Preferred Stock under the Series E AMI Sales Agreement.

Warrants

On August 30, 2018, warrants to purchase 39,040 shares of our common stock expired unexercised. As of April 30,2020 and 2019, we had no warrants issued and outstandingoutstanding.

 

Shares of Common Stock Authorized and Reserved for Future Issuance

 

On October 4, 2018, our stockholders approved an amendment to our Certificate of Incorporation to decrease our authorized number of shares of common stock from 500,000,000 shares to 150,000,000 shares (the “Certificate of Amendment”). The Certificate of Amendment became effective upon filing with the Secretary of State of the State of Delaware on October 4, 2018.

As of April 30, 2019, 56,135,6972020, 56,483,065 shares of our common stock were issued and outstanding. Our common stock outstanding as of April 30, 20192020 excluded the following shares of common stock reserved for future issuance:issuance (in thousands):

 

 Shares
Stock Incentive Plans7,264,7136,941
Employee Stock Purchase Plan1,196,2611,149
Conversion of our outstanding Series E Preferred Stock(1)6,826,435

_____________

(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.

 506,826
Total common stock reserved for future issuance14,916 

avid bioservices, inc.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(in thousands, except share and per share information)

 

Note 56 – Benefit Plans

 

Stock Incentive Plans

 

On October 4, 2018 (the “Effective Date”), our stockholders approved theThe Avid Bioservices, Inc. 2018 Omnibus Incentive Plan (the “2018 Plan”) is a stockholder-approved plan, which provides, among other things, the ability for us to grant stock options, restricted stock units and other forms of stock-based awards.

The number of shares of our common stock authorized for issuance under the 2018 Plan is the sum of (A) 2,350,000 and (B) the aggregate number of shares of common stock available for the grant of awards underreplaced our 2009, 2010 and 2011 Stock Incentive Plans (the “Prior Plans”) as of the Effective Date. The 2018 Plan replaced the Prior Plans, and no new awards will be granted under the Prior Plans as of the Effective Date.. However, any awards outstanding under the Prior Plans onas of the Effective Date2018 Plan’s effective date will remain subject to and be paid under the applicable Prior Plan, and any shares subject to outstanding awards under the Prior Plans that subsequently expire, terminate, or are surrendered or forfeited for any reason without issuance of shares will automatically become available for issuance under the 2018 Plan.

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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

In addition, we currently maintain three expired stock incentive plans referred to as the 2005, 2003 and 2002 Stock Incentive Plans (collectively, the “Expired Plans”). No future grants of stock-based awards can be issued from the Expired Plans, however, all outstanding awards granted under the Expired Plans will remain subject to the terms of the Expired Plans until they are exercised, canceled or expired.

 

The 2018 Plan, the Prior Plans, and the Expired Plans are collectively referred to as the “Stock Plans”. As of April 30, 2019,2020, we had an aggregate of 7,264,7136,941,049 shares of our common stock reserved for issuance under the Stock Plans, of which 3,474,5903,203,034 shares were subject to outstanding stock options and restricted stock units and 3,790,1233,738,015 shares were available for future grants of stock-based awards.

 

Stock Options

 

Stock options granted under our Stock Plans are granted at an exercise price not less than the fair market value of our common stock on the date of grant. Stock option grants to employees generally vest 25% on each of the first, second, third and fourth anniversaries of the date of grant, and stock option grants to non-employee directors generally vest over a period of one to three years from the date of grant. TheStock options generally have a contractual term of seven years; however, the maximum contractual term of any stock option granted under the Stock Plans is ten years.

 

The estimated fair value of stock options are measured at the grant date, using a fair value based method, such as a Black-Scholes option valuation model, and is amortized as stock-based compensation expense on a straight-line basis over the requisite service period of the award, which is generally the vesting period. The use of a valuation model requires us to make certain estimates and assumptions with respect to selected model inputs. The expected volatility is based on the daily historical volatility of our common stock covering the estimated expected term. The expected term of options granted reflects actual historical exercise activity and assumptions regarding future exercise activity of unexercised, outstanding options. The risk-free interest rate is based on U.S. Treasury notes with terms within the contractual life of the option at the time of grant. The expected dividend yield assumption is based on our expectation of future dividend payouts. We have never declared or paid any cash dividends on our common stock and currently do not anticipate paying such cash dividends.

 

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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(in thousands, except share and per share information)

The fair value of stock options on the date of grant and the weighted-average assumptions used to estimate the fair value of the stock options using the Black-Scholes option valuation model for fiscal years ended April 30, 2020, 2019 2018 and 2017,2018, were as follows:

 

 Fiscal Year Ended April 30,  Fiscal Year Ended April 30, 
 2019  2018  2017  2020  2019  2018 
Risk-free interest rate  2.81%   2.21%   1.32%   1.86%   2.81%   2.21% 
Expected life (in years)  5.57   6.19   6.12   5.06   5.57   6.19 
Expected volatility  76.56%   110.43%   111.30%   77.45%   76.56%   110.43% 
Expected dividend yield                  

49

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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

The following summarizes our stock option transaction activity for the fiscal year ended April 30, 2019:2020:

 

 Stock Options  

Grant Date

Weighted

Average Exercise

Price

 

Weighted

Average

Remaining

Contractual

Life (in years)

 

Aggregate

Intrinsic

Value(1)

  

Stock Options

(in thousands)

 

Grant Date

Weighted

Average Exercise

Price

 

Weighted

Average

Remaining

Contractual

Life (in years)

 

Aggregate

Intrinsic

Value(1)

(in thousands)

 
Outstanding at May 1, 2018  3,597,738  $8.74         
Outstanding at May 1, 2019  3,274  $7.51         
Granted  973,614  $5.00           887  $5.91         
Exercised  (371,327) $3.45           (251) $3.73         
Canceled or expired  (925,810) $11.28           (1,014) $10.79         
Outstanding at April 30, 2019  3,274,215  $7.51   5.53  $1,238 
Outstanding at April 30, 2020  2,896  $6.20   5.76  $2,457 
Vested and expected to vest  3,274,215  $7.51   5.53  $1,238   2,896  $6.20   5.76  $2,457 
Exercisable at April 30, 2019  1,932,527  $9.45   3.87  $700 
Exercisable at April 30, 2020  1,530  $6.77   4.89  $1,566 

______________

(1)Aggregate intrinsic value represents the difference between the exercise price of an option and the closing market price of our common stock on April 30, 2019,2020, which was $4.79$6.10 per share.

 

The weighted-average grant date fair value of options granted to employees during the fiscal years ended April 30, 2020, 2019 and 2018 was $3.74, $3.30 and 2017 was $3.30, $3.50 and $2.86 per share, respectively.

 

The aggregate intrinsic value of stock options exercised during the fiscal years ended April 30, 2020, 2019 and 2018 was $0.7 million, $0.5 million and 2017 was $547, $173 and $11,$0.2 million, respectively. Cash received from stock options exercised during fiscal years ended April 30, 2020, 2019 and 2018 totaled $0.9 million, $1.3 million and 2017, totaled $1,278, $752 and $31,$0.8 million, respectively.

 

We issue shares of common stock that are reserved for issuance under the Stock Plans upon the exercise of stock options, and we do not expect to repurchase shares of common stock from any source to satisfy our obligations under our compensation plans.

 

As of April 30, 2019,2020, the total estimated unrecognized compensation cost related to non-vested employee stock options was $3,880.$4.1 million. This cost is expected to be recognized over a weighted average vesting period of 2.702.66 years based on current assumptions.

52

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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(in thousands, except share and per share information)

 

Restricted Stock

 

A restricted stock unit (“RSU”) represents the right to receive one share of our common stock upon the vesting of each unit. RSUs generally vest over four years at the rate of one-fourth of the shares granted on each anniversary of the date of grant. The estimated fair value of RSUs is based on the closing market value of our common stock on the date of grant, and is amortized as stock-based compensation expense on a straight-line basis over the period of vesting.

 

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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

The following summarizes our RSUs transaction activity for the fiscal year ended April 30, 2019:2020:

 

   Shares  

Weighted Average

Grant Date

Fair Value

 
 Outstanding at May 1, 2018     $ 
 Granted   217,200   4.28 
 Vested       
 Forfeited   (16,825)  3.78 
 Outstanding at April 30, 2019   200,375  $4.32 
   

Shares

(in thousands)

  

Weighted Average

Grant Date

Fair Value

 
Outstanding at May 1, 2019   200  $4.32 
Granted   194   5.91 
Vested   (49)  4.30 
Forfeited   (38)  5.07 
Outstanding at April 30, 2020   307  $5.23 

 

There were noThe weighted-average grant date fair value of RSUs granted during the fiscal years ended April 30, 20182020 and 2017. 2019 was $5.91 and $4.28 per share, respectively. No RSUs were granted during the fiscal year ended April 30, 2018.

The total fair value of RSUs vested during the fiscal year ended April 30, 2020 was $0.3 million. No RSUs vested during the fiscal years ended April 30, 2019 and 2018.

As of April 30, 2019,2020, the total estimated unrecognized compensation cost related to non-vested RSUs was $733.$1.3 million. This cost is expected to be recognized over a weighted average vesting period of 3.342.82 years.

 

Employee Stock Purchase Plan

 

The Avid Bioservices, Inc. 2010 Employee Stock Purchase Plan (the “ESPP”) is a stockholders’-approvedstockholder-approved plan under which allows eligible employees tocan purchase shares of our common stock, through payroll deductions atbased on a percentage of their compensation, subject to certain limits. The purchase price per share is equal to 85%the lower of the lower85% of the fair market value of our common stock as ofon the first trading day of the offering period or on the last trading day of the six-month offering period. Employee participants are limitedOn October 9, 2019, our stockholders approved an amendment to purchase no more than $25,000the ESPP to extend its term for an additional five years to October 21, 2025 and to change the commencement dates of stock in any one calendarthe six-month offering periods from May 1 and November 1 of each year to January 1 and July 1 of each year.

During the fiscal years ended April 30, 2020, 2019 2018 and 2017,2018, a total of 47,526, 75,148 88,327 and 270,07588,327 shares of our common stock were purchased, respectively, under the ESPP at a weighted average purchase price per share of $3.94, $3.44 $3.59 and $1.95,$3.59, respectively. As of April 30, 2019,2020, we had 1,196,2611,148,735 shares of our common stock reserved for issuance under the ESPP.

 

The fair value of the shares purchased under the ESPP was determined using a Black-Scholes option pricingvaluation model (see explanation of valuation model inputs above under “Stock Options”), and is recognized as expense on a straight-line basis over the requisite service period (or six-month offering period).

 

51

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The weighted average grant date fair value of purchase rights under the ESPP during fiscal years ended April 30, 2020, 2019 and 2018 was $1.81, $1.49 and 2017 was $1.49, $1.65, and $1.07, respectively, based on the following weighted-average Black-Scholes option valuation model inputs:

 

  Fiscal Year Ended April 30, 
  2019  2018  2017 
Risk-free interest rate  2.26%   1.10%   0.46% 
Expected life (in years)  0.50   0.50   0.50 
Expected volatility  71.10%   75.18%   105.27% 
Expected dividend yield         

53

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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(in thousands, except share and per share information)

  Fiscal Year Ended April 30, 
  2020  2019  2018 
Risk-free interest rate  2.08%   2.26%   1.10% 
Expected life (in years)  0.50   0.50   0.50 
Expected volatility  56.71%   71.10%   75.18% 
Expected dividend yield         

 

401(k) Plan

 

We havemaintain a 401(k) Plan (the “Plan”) pursuant to section 401(k) of the Internal Revenue Code that allows participating employees to contribute up to 100%defer a portion of their compensation on a tax deferred basis up to the maximum amount permitted by the Internal Revenue Code. We match 50% of employee contributions of up to 6% of their annual eligible compensation. The expense related to our matching contributions to the 401(k) Plan was $377, $564$0.5 million, $0.4 million and $845$0.6 million for the fiscal years ended April 30, 2020, 2019 2018 and 2017,2018, respectively.

 

Stock-based Compensation Expense

 

Stock-based compensation expense for the fiscal years ended April 30, 2020, 2019 2018 and 20172018 was comprised of the following:following (in thousands):

 

 Fiscal Year Ended April 30,  Fiscal Year Ended April 30, 
 2019  2018  2017  2020  2019  2018 
Cost of revenues $474  $378  $108  $922  $474  $378 
Selling, general and administrative expense  1,121   820   1,553   1,577   1,121   820 
Discontinued operations
     340   1,702         340 
Total $1,595  $1,538  $3,363  $2,499  $1,595  $1,538 

 

Due to our net loss position, no tax benefits have been recognized in the Consolidated Statements of Cash Flows.

 

Note 67 – Income Taxes

 

We are primarily subject to U.S. federal and California state jurisdictions. To our knowledge, allAll tax years with tax attributes carrying forward remain open to examination by U.S. federal and state authorities.

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In accordance with ASC 740, we are required to recognize the impact of an uncertain tax position in the consolidated financial statements when it is more likely than not the position will be sustained upon examination by the tax authorities. An uncertain tax position will not be recognized if it has less than a 50% likelihood of being sustained upon examination by the tax authorities. We had no unrecognized tax benefits from uncertain tax positions as of April 30, 20192020 and 2018.2019. It is also our policy, in accordance with authoritative guidance, to recognize interest and penalties related to income tax matters in interest and other expense in our consolidated statementsConsolidated Statements of operationsOperations and comprehensive loss.Comprehensive Loss. We did not recognize interest or penalties related to income taxes for fiscal years ended April 30, 2020, 2019, 2018, and 2017,2018, and we did not accrue for interest or penalties as of April 30, 20192020 and 2018.

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(in thousands, except share and per share information)

2019.

 

Deferred income tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial reporting and tax bases of assets and liabilities and are measured using enacted tax rates in effect for the year in which those temporary differences are expected to be recovered or settled. A valuation allowance is provided for the amount of deferred tax assets that, based on available evidence, are not expected to be realized. As a result of our cumulative losses, management has concluded that a full valuation allowance against our net deferred tax assets is appropriate.

 

At April 30, 2019,2020, we had net deferred tax assets of $119,516.$118.1 million. Due to uncertainties surrounding our ability to generate future taxable income to realize these tax assets, a full valuation has been established to offset our net deferred tax assets. Additionally, the future utilization of our net operating loss carry forwards to offset future taxable income may be subject to an annual limitation, pursuant to Internal Revenue Code Section 382, as a result of ownership changes that may have occurred previously or that could occur in the future. A Section 382 analysis was completed as of the fiscal year ended April 30, 20182019 and we subsequently reviewed ownership activity through April 30, 2019,2020, which it was determined that no significant change in ownership had occurred. However, ownership changes occurring subsequent to April 30, 20192020 may impact the utilization of net operating loss carry forwards and other tax attributes.

 

At April 30, 2019,2020, we had federal net operating loss carry forwards of approximately $425,841.$427 million. The federal net operating loss carry forwards generated prior to January 1, 2018 expire in fiscal years 20202021 through 2038. The federal net operating loss generated after January 1, 2018 of $6,609$19.8 million can be carried forward indefinitely and be availableindefinitely. Net operating losses generated after 2017 through 2020 may offset future taxable income without limitation. Utilization of net operating losses generated subsequent to offset up2020 are limited to 80% of future taxable income each year.income. We also have California state net operating loss carry forwards of approximately $273,581$277 million at April 30, 2019,2020, which begin to expire in fiscal year 2029.

 

The provision for income taxes on our loss from continuing operations for the fiscal years ended April 30, 2020, 2019 and 2018 and 2017 areis comprised of the following:following (in thousands):

 

  2019  2018  2017 
Federal income taxes at statutory rate $(1,120) $(6,112) $475 
State income taxes  (48)  155   309 
Expiration and adjustments of deferred tax assets  2,507   1,840   1,693 
Change in valuation allowance  (2,480)  (57,599)  (2,616)
Stock-based compensation  1,309   1,584    
Other, net  (452)  6   139 
Tax Cuts and Jobs Act     60,126    
Income tax benefit $(284) $  $ 

  2020  2019  2018 
Federal income taxes at statutory rate $(2,197) $(1,120) $(6,112)
State income taxes     (48)  155 
Expiration of deferred tax assets  2,588   2,507   1,840 
Change in valuation allowance  (1,664)  (2,480)  (57,599)
Stock-based compensation  1,138   1,309   1,584 
Other, net  135   (452)  6 
Tax Cuts and Jobs Act        60,126 
Income tax benefit $  $(284) $ 

 

 

 

 5553 

avid bioservices, inc.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(in thousands, except share and per share information)

 

 

Deferred income taxes reflect the net effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts for income tax purposes. Significant components of our deferred tax assets and deferred tax liabilities at April 30, 20192020 and 20182019 are as follows:

 

  2019  2018 
Net operating losses $113,612  $115,236 
Stock-based compensation  3,416   4,828 
Deferred revenue  1,610   2,852 
Deferred rent  555   568 
Other  1,256   879 
Total deferred tax assets  120,449   124,363 
Less valuation allowance  (119,516)  (123,555)
Total deferred tax assets, net of valuation allowance $933  $808 
Deferred tax liabilities:        
Fixed assets  (933)  (808)
Total deferred tax liabilities  (933)  (808)
Net deferred tax assets $  $ 

On May 1, 2018, we adopted ASC 606 (Note 2). Upon adoption, no change in retained earnings was recorded related to income taxes as we maintain a full valuation allowance. However, an adjustment of approximately $700 was recorded as a deferred tax liability and a corresponding reduction to the valuation allowance.

  2020  2019 
Net operating losses $114,105  $113,612 
Stock-based compensation  2,573   3,416 
Deferred revenue  810   1,610 
Deferred rent     555 
Lease liabilities  6,324    
Other  1,197   1,256 
Total deferred tax assets  125,009   120,449 
Less valuation allowance  (118,137)  (119,516)
Total deferred tax assets, net of valuation allowance  6,872   933 
         
Deferred tax liabilities:        
Fixed assets  (1,216)  (933)
Right-of-use assets  (5,656)   
Total deferred tax liabilities  (6,872)  (933)
Net deferred tax assets $  $ 

 

On May 1, 2017, we adopted ASU 2016-09. Upon adoption, we have excessMarch 27, 2020, the CARES Act was signed into law. The CARES Act provides numerous tax benefitsprovisions and other stimulus measures, including temporary changes regarding the prior and future utilization of net operating losses, temporary changes to the prior and future limitations on interest deductions, temporary suspension of certain payment requirements for which a benefit could not previously be recognizedthe employer portion of approximately $2,400. The balanceSocial Security taxes, the creation of certain refundable employee retention credits, and technical corrections from prior tax legislation for tax depreciation of certain qualified improvement property. Due to our loss position, many of the unrecognized excess tax benefits has been reversed with the impact recorded to retained earnings including any change to the valuation allowance as a resultprovisions of the adoption. Due toCARES Act do not impact us and the full valuation allowanceCARES Act does not have a significant impact on the U.S. deferredour income tax assets, there was no impact to the accompanying consolidated financial statements as a result of adopting ASU 2016-09 other than what is reflected in the accompanying Consolidated Statements of Stockholders’ Equityprovision for the fiscal year ended April 30, 2018.2020.

In December 2017, the Tax Cuts and Jobs Act (the “Tax Act”) was enacted. The Tax Act includes a number of changes to existing U.S. tax laws that impact us, most notably a reduction of the U.S. corporate income tax rate from 35% to 21% for tax years, effective January 1, 2018. We performed a review of the Tax Act for the fiscal year ended April 30, 2018, and based on the information available at that time, we recorded a provisional increase in tax expense and a corresponding decrease in net deferred tax assets of $60,126, which were fully offset by a valuation allowance.

We applied the guidance under Staff Accounting Bulletin No. 118 when accounting for the enactment-date effects of the Tax Act for the fiscal year ended April 30, 2018 as we had not completed our accounting for all the enactment-date income tax effects of the Tax Act under ASC 740 for the remeasurement of deferred tax assets and liabilities. We completed our accounting for the enactment-date income tax effects of the Tax Act during the quarter ended January 31, 2019. Upon further analyses of the Tax Act and Notices and regulations issued and proposed by the U.S. Department of the Treasury and the Internal Revenue Service provisional amount recognized for the fiscal year ended April 30, 2018 did not change; therefore, there was no adjustment to tax expense.

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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(in thousands, except share and per share information)

 

Note 78 – Net Loss per Common Share

 

Basic net loss per common share is computed by dividing our net loss 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, unvested RSUs, shares of common stock expected to be issued under our ESPP, warrants, and Series E Preferred Stock outstanding during the period. Diluted net loss per common share is computed by dividing our net loss 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, shares of common stock expected to be issued under our ESPP, warrants, and Series E Preferred Stock outstanding during the period.

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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

Net loss attributable to common stockholders represents our net loss plus 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, 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 Series E Preferred Stock outstanding during the period wasis calculated using the if-converted method assuming the conversion of 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, becauseSince the impact of stock options, unvested RSUs, shares of common stock expected to be issued under our ESPP, warrants, and Series E Preferred Stockpotentially dilutive securities are anti-dilutive during periods of net loss, there was no difference between basic and diluted loss per common share amounts for the threefiscal years ended April 30, 2019.2020, 2019 and 2018.

 

The calculation of weighted average diluted shares outstanding excludes the dilutive effect of the following weighted average outstanding stock options, unvested RSUs and shares of common stock expected to be issued under our ESPPsecurities, as their impacteffect is anti-dilutive during periods of net loss:loss (in thousands):

 

 2019  2018  2017  2020  2019  2018 
Stock options  138,822   53,978      145   139   54 
RSUs  34,122         76   34    
ESPP  10,589   1,972   45,767   7   11   2 
Total  183,533   55,950   45,767   228   184   56 

 

The calculation of weighted average diluted shares outstanding also excludes the following weighted average outstanding stock options, unvested RSUs, warrants, and Series E Preferred Stock (assuming the if-converted method),securities, as their exercise prices or conversion price were greater than the average market price of our common stock during the respective periods, resulting in an anti-dilutive effect:effect (in thousands):

 

  2019  2018  2017 
Stock options  2,712,454   3,636,699   4,156,421 
RSUs  33,532       
Warrants  12,942   39,040   39,040 
Series E Preferred Stock  1,978,783   1,978,783 �� 1,955,588 
Total  4,737,711   5,654,522   6,151,049 

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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(in thousands, except share and per share information)

  2020  2019  2018 
Stock options  2,650   2,712   3,637 
RSUs  7   34    
Warrants     13   39 
Series E Preferred Stock  1,979   1,979   1,979 
Total  4,636   4,738   5,655 

 

Note 89 – Commitments and Contingencies

 

In 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.

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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. We are 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 impacts our future business, strategic initiatives, results of operations orand financial position.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 to what extent normal economic and operating conditions can resume.

 

Note 910 – Restructuring Charges

 

In August 2017, we 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 focused 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 fiscal quarter ended October 31, 2017, we incurred an aggregate of $1,588$1.6 million in restructuring costs consisting of termination benefits, including severance, and other employee-related costs, of which $330 related to our$0.3 million is from discontinued researchoperations and development segment and $1,258 related to our contract manufacturing services segment.$1.3 million is from continuing operations. The restructuring costs associated with ourfrom discontinued research and development segmentoperations are included in income (loss)loss from discontinued operations, net of tax, in the accompanying consolidated financial statementsConsolidated Financial Statements for the fiscal year ended April 30, 2018 (Note 10)11). The restructuring costs associated with our contract manufacturing services segmentfrom continuing operations are included in operating expenses in the accompanying consolidated financial statementsConsolidated Financial Statements for the fiscal year ended April 30, 2018. All restructuring costs were paid in full during fiscal year 2018.

 

Note 1011 – Sale of Research and Development Assets

 

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

 

Pursuant to the February 2018 Purchase Agreement, we received an aggregate of $8,000$8.0 million from Oncologie, of which $3,000$3.0 million was received in fiscal year 2018 and $5,000$5.0 million was received in fiscal year 2019. We are also eligible to receive up to an additional $95,000$95.0 million in the event that Oncologie 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 Oncologie commercializes and sells products utilizing bavituximab or the other transferred assets. As of April 30, 2019,2020, no development, regulatory or commercialization milestones have been achieved by Oncologie.Oncologie under the February 2018 Purchase Agreement. Oncologie 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 February 2018 Purchase Agreement incurred or arising prior to February 12, 2018).assets.

 

OnIn September 13, 2018, we entered into a separate Asset Assignment and Purchase Agreement (the “September 2018 Purchase Agreement”) with Oncologie, pursuant to which we sold to Oncologie our r84 technology, which included the assignment of certain licenses, patents and other assets useful and/or necessary for the potential commercialization of the r84 technology.

 

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(in thousands, except share and per share information)

Pursuant to the September 2018 Purchase Agreement, we received $1,000$1.0 million from Oncologie, which amount was paid to us in October 2018.fiscal year 2019. We are also eligible to receive up to an additional $21,000$21.0 million in the event that Oncologie achieves certain development, regulatory and commercialization milestones with respect to r84. In addition, we are eligible to receive royalties on net sales ranging from the low to mid-single digits in the event that Oncologie commercializes and sells products utilizing the r84 technology. As of April 30, 2019,2020, no development, regulatory or commercialization milestones have been achieved by Oncologie.Oncologie under the September 2018 Purchase Agreement. Oncologie is responsible for all future research, development and commercialization of r84, 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 September 2018 Purchase Agreement incurred or arising prior to September 13, 2018).assets.

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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

Discontinued Operations

 

As a result of the sale of our PS-targeting program and our r84 technology,technologies, the abandonment of our remaining research and development assets, and the strategic shift in our corporate direction to focus solely on our CDMO business, the operating results from our former research and development segment and the related assets and liabilities have been excluded from continuing operations and presented as discontinued operations in the accompanying consolidated financial statementsConsolidated Financial Statements for all periods presented. During the fiscal years ended April 30, 2019 and 2018, we recorded a gain of $1,000$1.0 million and $8,000,$8.0 million, respectively, upon the completion of the September 2018 Purchase Agreement and the February 2018 Purchase Agreement, which amounts are included in income (loss) from discontinued operations, net of tax, in the accompanying Consolidated Statements of Operations and Comprehensive Loss for the fiscal years ended April 30, 2019 and 2018, respectively. The results of operations from discontinued operations presented below include certain allocations that management believes fairly reflect the utilization of services provided to the former research and development segment. The allocations do not include amounts related to general corporate administrative expenses or interest expense. Therefore, these results of operations do not necessarily reflect what the results of operations would have been had the former research and development segment operated as a stand-alone segment.

 

There were no operating results from discontinued operations for the fiscal year ended April 30, 2020.

The following table summarizes the results of discontinued operations for the fiscal years ended April 30, 2019 and 2018 and 2017:(in thousands):

 

  2019  2018  2017 
          
License revenue $  $25  $ 
             
Operating expenses:            
Research and development     6,782   27,992 
Selling, general and administrative     2,163   1,560 
Restructuring charges     330    
Total operating expenses     9,275   29,552 
             
Other income  125       
Gain on sale of research and development assets before income taxes  1,000   8,000    
Income tax expense  284       
Income (loss) from discontinued operations, net of tax $841  $(1,250) $(29,552)

  Fiscal Year Ended April 30, 
  2019  2018 
License revenue $  $25 
Operating expenses:        
Research and development     6,782 
Selling, general and administrative     2,163 
Restructuring charges     330 
Total operating expenses     9,275 
         
Other income  125    
Gain on sale of research and development assets before income taxes  1,000   8,000 
Income tax expense  284    
Income (loss) from discontinued operations, net of tax $841  $(1,250)

 

 

 

 5957 

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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(in thousands, except share and per share information)

The following table includes the assets and liabilities of discontinued operations as of April 30, 2018. There were no assets or liabilities related to discontinued operations as of April 30, 2019:

  2018 
Assets:    
Other receivables $5,000 
     
Total assets of discontinued operations $5,000 
     
Liabilities:    
Accounts payable $32 
Accrued clinical trial and related fees  3,613 
Accrued payroll and related costs  614 
Other liabilities  291 
Total liabilities of discontinued operations $4,550 

The carrying value of the assets and liabilities deemed a component of the discontinued research and development segment were not classified as “held for sale” in the accompanying Consolidated Balance Sheet at April 30, 2018 as Oncologie did not purchase or assume any of the reported assets or liabilities under the aforementioned February 2018 Purchase Agreement and September 2018 Purchase Agreement.

 

Note 1112 – Selected Quarterly Financial Data (Unaudited)

 

SelectedThe following is a summary of our unaudited quarterly financial informationresults for each of the two most recent fiscal years is as follows:(in thousands, except per share amounts):

 

  Fiscal Year Ended April 30, 2019(a) 
   First Quarter   Second Quarter   Third Quarter   Fourth Quarter 
Revenues $12,589  $10,178  $13,781  $17,055 
Gross profit $1,192  $334  $2,050  $3,648 
(Loss) income from continuing operations $(1,961) $(2,190) $(1,139) $234 
Income from discontinued operations, net of tax(b)(c) $  $739  $  $102 
Net (loss) income $(1,961) $(1,451) $(1,139) $336 
Net loss attributable to common stockholders $(3,403) $(2,893) $(2,581) $(1,106)
Basic and diluted net (loss) income per common share attributable to common stockholders(d)                
Continuing operations $(0.06) $(0.06) $(0.05) $(0.02)
Discontinued operations $  $0.01  $  $ 
Net loss per common share attributable to common stockholders $(0.06) $(0.05) $(0.05) $(0.02)
  Fiscal Year Ended April 30, 2020 
   

First

Quarter

   

Second

Quarter

   

Third

Quarter

   

Fourth

Quarter

 
Revenues(a) $15,254  $18,313  $13,585  $12,550 
Gross profit (loss) $1,086  $3,360  $785  $(1,299)
Loss from continuing operations, net of tax(b) $(3,164) $(430) $(2,104) $(4,768)
Net loss $(3,164) $(430) $(2,104) $(4,768)
Net loss attributable to common stockholders $(4,606) $(1,872) $(3,546) $(6,210)
Basic and diluted net loss per common share attributable to common stockholders(c) $(0.08) $(0.03) $(0.06) $(0.11)

 

 

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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(in thousands, except share and per share information)

  

Fiscal Year Ended April 30, 2018(a)

 
   First Quarter   Second Quarter   Third Quarter   Fourth Quarter 
Revenues $27,077  $12,782  $6,819  $6,943 
Gross profit (loss) $6,629  $(3,460) $(4,132) $(1,961)
Income (loss) from continuing operations $2,800  $(8,301) $(8,928) $(6,134)
(Loss) income from discontinued operations, net of tax(b)(c) $(4,005) $(4,323) $(2,076) $9,154 
Net (loss) income $(1,205) $(12,624) $(11,004) $3,020 
Net (loss) income attributable to common stockholders $(2,647) $(14,066) $(12,446) $1,578 
Basic and diluted net income (loss) per common share attributable to common stockholders(d)                
Continuing operations $0.03  $(0.21) $(0.23) $(0.14)
Discontinued operations $(0.09) $(0.10) $(0.05) $0.17 
Net (loss) income per common share attributable to common stockholders $(0.06) $(0.31) $(0.28) $0.03 
   Fiscal Year Ended April 30, 2019 
   

First

Quarter

   

Second

Quarter

   

Third

Quarter

   

Fourth

Quarter

 
Revenues $12,589  $10,178  $13,781  $17,055 
Gross profit $1,192  $334  $2,050  $3,648 
(Loss) income from continuing operations, net of tax $(1,961) $(2,190) $(1,139) $234 
Income from discontinued operations, net of tax(d)(e) $  $739  $  $102 
Net (loss) income $(1,961) $(1,451) $(1,139) $336 
Net loss attributable to common stockholders $(3,403) $(2,893) $(2,581) $(1,106)
Basic and diluted net (loss) income per common share attributable to common stockholders(c)                
Continuing operations $(0.06) $(0.06) $(0.05) $(0.02)
Discontinued operations $  $0.01  $  $ 
Net loss per common share attributable to common stockholders $(0.06) $(0.05) $(0.05) $(0.02)

________________

(a)On May 1, 2018, we adopted ASC 606 using the modified retrospective method applied to all contracts not completed as of May 1, 2018 (Note 2). Under the modified retrospective method, resultsRevenues for the reporting periods beginning on or after May 1, 2018 are presentedfourth quarter of fiscal year ended April 30, 2020, includes a $1.5 million reduction due to changes in accordance with ASC 606, while prior period amounts are not adjusted and continueestimates for variable consideration as compared to be reported under the accounting standards that were in effect prior to May 1, 2018.third quarter of fiscal year ended April 30, 2020.
(b)For all periods presented, the operating results of our former research and development segment are reported as income (loss)Loss from discontinuedcontinuing operations net of tax (Note 1).
(c)Income from discontinued operations, net of tax, for the quarterssecond quarter of fiscal year ended October 31, 2018 and April 30, 2018 include2020 includes a gainloss on salelease termination of research and development assets before tax of $1,000 and $8,000, respectively$0.4 million (Note 10).4)
(d)(c)Basic and diluted net income (loss) per common share attributable to common stockholders calculations for each of the quarters are based on the basic and diluted weighted average common shares outstanding for each period. As such, the sum of the quarters may not necessarily equal the basic and diluted net (loss) income (loss) per common share amount for the fiscal year.
(d)For the fiscal year ended April 30, 2019, the operating results of our former research and development segment are reported as income from discontinued operations, net of tax (Note 1).There were no operating results from discontinued operations for the fiscal year ended April 30, 2020.
(e)Income from discontinued operations, net of tax, for the second quarter of fiscal year ended April 30, 2019 includes a gain on sale of research and development assets before tax of $1.0 million (Note 11).

58

avid bioservices, inc.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

Note 1213 – Subsequent Events

 

Repayment of PPP Loan

On May 12, 2020, we paid off in full the principal and interest on the PPP Loan, resulting in the termination of the Note (Note 3).

Series E Preferred Stock Dividend

On June 5, 2019,3, 2020, 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 April 1, 20192020 through June 30, 2019.2020.  The cash dividend of $1,081$1.1 million is payable on July 1, 20192020 to holders of the Series E Preferred Stock of record on June 17, 2019.15, 2020.

 

 

 

 

 6159 

 

Item 9.Changes In And Disagreements With Accountants On Accounting And Financial Disclosures

 

None.

 

Item 9A.Controls And Procedures

 

Evaluation of Disclosure Controls and Procedures

 

The term “disclosure controls and procedures” defined in Rule 13a-15(e) under the Exchange Act refers to the controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files under the Exchange Act is recorded, processed, summarized and reported within the required time periods. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can only provide reasonable assurance of achieving the desired control objectives, and in reaching a reasonable level of assurance, management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Under the supervision and with the participation of our management, including our interim chief executive officer and chief financial officer, we have conducted an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures as of April 30, 2019.2020. Based on this evaluation, our interim president and chief executive officer and our chief financial officer concluded that our disclosure controls and procedures were effective as of April 30, 20192020 to ensure the timely disclosure of required information in our SEC filings.

 

Management’s Report on Internal Control Over Financial Reporting

Management is responsible for establishing and maintaining adequate internal control over financial reporting and for the assessment of the effectiveness of internal control over financial reporting. The Company’s internal control over financial reporting is a process designed, as defined in Rule 13a-15(f) under the Exchange Act, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements for external purposes in accordance with generally accepted accounting principles.

 

The Company’s internal control over financial reporting is supported by written policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the Company’s assets; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of consolidated financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the Company are being made only in accordance with authorizations of the Company’s management and directors; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on the consolidated financial statements. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

 

In connection with the preparation of the Company’s annual consolidated financial statements, management of the Company has undertaken an assessment of the effectiveness of the Company’s internal control over financial reporting based on criteria established in Internal Control - Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework). Management’s assessment included an evaluation of the design of the Company’s internal control over financial reporting and testing of the operational effectiveness of the Company’s internal control over financial reporting.

 

Based on this assessment, management has concluded that the Company’s internal control over financial reporting was effective as of April 30, 2019.2020.

 

Our internal control over financial reporting as of April 30, 20192020 has been audited by Ernst & Young LLP, an independent registered public accounting firm, as stated in their report included herein.

 

62

Changes in Internal Control over Financial Reporting

Management has determined that, as of April 30, 2019,2020, there were no significant changes in our internal control over financial reporting during the fourth quarter of the fiscal year ended April 30, 20192020 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

  

Item 9B.Other Information

On June 26, 2019 (the “Effective Date”), we entered into an employment agreement with our chief financial officer, Daniel R. Hart (the “Employment Agreement”), who has served in this capacity since August 1, 2018. The Employment Agreement provides for an initial two-year term commencing on the Effective Date, unless sooner terminated as provided in the Employment Agreement. On each anniversary of the Effective Date, the term of the Employment Agreement will automatically be extended for an additional one (1) year period, unless either we or Mr. Hart gives to the other written notice at least ninety (90) days prior to the expiration of the then current year period, of such party’s intent not to extend Employment Agreement.

Pursuant to the terms of the Employment Agreement, Mr. Hart is entitled to receive an annual base salary of $397,000 and is eligible for an annual discretionary cash bonus of up to forty-five percent (45%) of his then in effect annual base salary as determined by the Compensation Committee of the Board of Directors in accordance with the our cash bonus plan for executives then in effect and in its sole discretion.

Mr. Hart is eligible to participate in all benefits plans or arrangements which may be in effect from time to time and made available by us to our executive management employees.

If Mr. Hart’s employment is terminated by us other than for cause or if he resigns for good reason (within the meaning given to such terms in the Employment Agreement), Mr. Hart will be entitled to receive, subject to his execution of a general release of claims, (i) continued base salary for a period of twelve (12) months, (i) COBRA continuation coverage for him and his family for a period of up to twelve (12) months paid by us, and (iii) 100% of his annual cash bonus pro rata portion for the year in which his termination occurs and payable at the time other executive management employees receive their discretionary bonuses. Mr. Hart will be subject to non-solicitation restrictions for a period of one year following any termination of his employment.

The foregoing description of the Employment Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Employment Agreement, a copy of which is filed as an exhibit to this Annual Report on Form 10-K and is incorporated herein by reference.

 

 6360 

 

Report of Independent Registered Public Accounting Firm

 

To the Stockholders and the Board of Directors of Avid Bioservices, Inc.

 

Opinion on Internal Control over Financial Reporting

 

We have audited Avid Bioservices, Inc.’s internal control over financial reporting as of April 30, 2019,2020, based on criteria established in Internal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria). In our opinion, Avid Bioservices, Inc. (the Company) maintained, in all material respects, effective internal control over financial reporting as of April 30, 2019,2020, based on the COSO criteria.

 

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of April 30, 20192020 and 2018,2019, the related consolidated statements of operations and comprehensive loss, stockholders’ equity and cash flows for each of the three years in the period ended April 30, 2019,2020, and the related notes and our report dated June 27, 201930, 2020 expressed an unqualified opinion thereon.

 

Basis for Opinion

 

The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management’s Report on Internal Control over Financial Reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

 

We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects.

 

Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.

 

Definition and Limitations of Internal Control Over Financial Reporting

 

A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.

 

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

 

/s/ Ernst & Young LLP

 

Irvine, California

June 27, 201930, 2020

 

 

 

Item 9B.Other Information

None.

 

 

 6461 

 

PART III

 

Item 10.Directors, Executive Officers And Corporate Governance

 

The information required by this Item regarding our directors, executive officers and committees of our board of directors is incorporated by reference to the information set forth under the captions, “Election of Directors,” “Executive Compensation” and “Corporate Governance” in our 20192020 Definitive Proxy Statement to be filed within 120 days after the end of our fiscal year ended April 30, 20192020 (the “2019“2020 Definitive Proxy Statement”).

 

Information required by this Item regarding Section 16(a) reporting compliance is incorporated by reference to the information set forth under the caption, “Section“Delinquent Section 16(a) Beneficial Ownership Reporting Compliance”Reports” in our 20192020 Definitive Proxy Statement.

 

Information required by this Item regarding our code of ethics is incorporated by reference to the information set forth under the caption, “Corporate Governance” in our 20192020 Definitive Proxy Statement.

 

Item 11.Executive Compensation

 

The information required by this Item is incorporated by reference to the information set forth under the captions, “Director Compensation,” “Compensation Discussion and Analysis” and “Executive Compensation” in our 20192020 Definitive Proxy Statement to be filed within 120 days after the end of our fiscal year ended April 30, 2019.2020.

 

Item 12.Security Ownership Of Certain Beneficial Owners And Management And Related Stockholder Matters

 

Other than as set forth below, the information required by this Item is incorporated by reference to the information set forth under the caption, “Security Ownership of Certain Beneficial Owners, Directors and Management” in our 20192020 Definitive Proxy Statement to be filed within 120 days after the end of our fiscal year ended April 30, 2019.2020.

 

Equity Compensation Plan Information

 

The following table summarizes our compensation plans under which our equity securities are authorized for issuance as of April 30, 2019:2020:

 

Plan Category

 

 

(a)

Number of Securities to be Issued Upon the Exercise of Outstanding Options, Warrants and Rights

 

(b)

Weighted-Average Exercise Price of Outstanding Options, Warrants and Rights ($/share)

 

(c)

Number of Shares Remaining Available for Future Issuance Under Equity Compensation Plans (Excluding Securities Reflected in Column (a))

  

 

(a)

Number of Securities to be Issued Upon the Exercise of Outstanding Options, Warrants and Rights

 

(b)

Weighted-Average Exercise Price of Outstanding Options, Warrants and Rights ($/share)

 

(c)

Number of Shares Remaining Available for Future Issuance Under Equity Compensation Plans (Excluding Securities Reflected in Column (a))

 
Equity compensation plans approved by stockholders(1)  3,462,587   7.49   3,790,123   3,193,204   6.17   3,738,015 
Equity compensation plans not approved by stockholders(2)  12,003   14.10      9,830   15.75    
Employee Stock Purchase Plan approved by stockholders        1,196,261         1,148,735 
Total  3,474,590   7.51(3)   4,986,384   3,203,034   6.20(3)   4,886,750 

____________________ ______________________

(1)Represents stock options and restricted stock units under our stockholder approved equity compensation plans referred to as the 2018 Omnibus Incentive Plan, the 2011 Stock Incentive Plan, the 2010 Stock Incentive Plan, the 2009 Stock Incentive Plan, the 2005 Stock Incentive Plan and the 2003 Stock Incentive Plan.
(2)Represents stock options under our 2002 Stock Incentive Plan (the “2002 Plan”), which was not submitted for stockholder approval. The 2002 Plan, which expired in June 2012, was a broad-based non-qualified stock option plan for the issuance of up to 85,714 stock options. The 2002 Plan provided for the granting of options to purchase shares of our common stock at prices not less than the fair market value of our common stock at the date of grant and generally expired ten years after the date of grant. No additional grants of stock options can be granted under the 2002 Plan, however, the terms of the 2002 Plan remain in effect with respect to the outstanding options granted under the 2002 Plan until they are exercised, canceled or expired
(3)Represents the weighted-average exercise price of outstanding stock options as there is no exercise price for restricted stock units.

 

 

 

 6562 

 

Item 13.Certain Relationships And Related Transactions, And Director Independence

 

The information required by this Item is incorporated by reference to the information set forth under the captions, “Certain Relationships and Related Transactions,” “Director Independence” and “Compensation Committee Interlocks and Insider Participation” in our 20192020 Definitive Proxy Statement to be filed within 120 days after the end of our fiscal year ended April 30, 2019.2020.

 

Item 14.Principal Accounting Fees and Services

 

The information required by this Item is incorporated by reference to the information set forth under the caption, “Independent Registered Public Accounting Firm Fees” in our 20192020 Definitive Proxy Statement to be filed within 120 days after the end of our fiscal year ended April 30, 2019.2020.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 6663 

 

PART IV

 

Item 15.Exhibits And Financial Statement Schedules

 

(a)Documents filed as part of this report on Form 10-K:

 

(1)Consolidated Financial Statements

 

Index to Consolidated Financial StatementsPage
Report of Independent Registered Public Accounting Firm3531
Consolidated Balance Sheets as of April 30, 20192020 and 201820193632
Consolidated Statements of Operations and Comprehensive Loss for each of the three years in the period ended
   April 30, 2019
2020
37
33
Consolidated Statements of Stockholders’ Equity for each of the three years in the period ended April 30, 201920203834
Consolidated Statements of Cash Flows for each of the three years in the period ended April 30, 201920203935
Notes to Consolidated Financial Statements4036

 

(2)       Financial Statement Schedules

(2)Financial Statement Schedules

 

All schedules are omitted as the required information is inapplicable, or the information is presented in the consolidated financial statements or related notes.

 

(3)       Exhibits

(3)Exhibits

 

The exhibits listed in the accompanying index to exhibits are filed or incorporated by reference as part of this report on Form 10-K.

 

Item 16.FORM 10-K SUMMARY

 

None.

 

 

 

64

EXHIBIT INDEX

    Incorporated by Reference 

Exhibit

Number

 

 

Description

 

 

Form

 

Date

Filed

 

Exhibit

Number

 

Filed

Herewith

 
3.1 Certificate of Incorporation, as amended through October 4, 2018 10-Q 12/10/2018 3.1   
3.2 Amended and Restated Bylaws 8-K 11/14/2014 3.2   
3.3 Amendment No. 1 to Amended and Restated Bylaws 8-K 3/13/2018 3.2   
4.1 Form of Certificate for Common Stock 10-K 1988 4.1   
4.2* 2002 Non-Qualified Stock Option Plan S-8 6/23/2006 4.17   
4.3* Form of 2002 Non-Qualified Stock Option Agreement S-8 6/23/2006 4.18   
4.4* 2003 Stock Incentive Plan Non-qualified Stock Option Agreement S-8 12/16/2004 10.95   
4.5* 2003 Stock Incentive Plan Incentive Stock Option Agreement S-8 12/16/2004 10.96   
4.6* 2010 Stock Incentive Plan DEF-14A 8/27/2010 A   
4.7* Form of Stock Option Award Agreement under 2010 Stock Incentive Plan S-8 12/9/2010 4.17   
4.8* 2010 Employee Stock Purchase Plan DEF-14A 8/27/2010 B   
4.9* Amendment to the 2010 Employee Stock Purchase Plan DEF-14A 8/26/2016 B   
4.10* 2011 Stock Incentive Plan DEF-14A 8/26/2011 A   
4.11* Form of Stock Option Award Agreement under 2011 Stock Incentive Plan S-8 12/12/2011 4.20   
4.12* First Amendment to 2011 Stock Incentive Plan DEF-14A 8/27/2012 A   
4.13* Second Amendment to 2011 Stock Incentive Plan DEF-14A 8/26/2013 A   
4.14* Third Amendment to 2011 Stock Incentive Plan 10-K 7/14/2015 4.24   
4.15* Form of Amendment to Stock Option Award Agreement Under 2011 Stock Incentive Plan related to Non-Employee Director stock option awards 10-K 7/14/2015 4.27   
4.16* Fourth Amendment to 2011 Stock Incentive Plan DEF-14A 8/28/2015 B   
4.17 Form of Indenture S-3 1/12/2018 4.4   
4.18* Avid Bioservices, Inc. 2018 Omnibus Incentive Plan DEF-14A 8/17/2018 A   
4.19* Form of Stock Option Award Agreement under 2018 Omnibus Incentive Plan S-8 12/10/2018 4.2   
              

 

 

 

 6765 

EXHIBIT INDEX

Exhibit
Number

Description

3.1Certificate of Incorporation of Avid Bioservices, Inc., a Delaware corporation, as amended through October 4, 2018 (Incorporated by reference to Exhibit 3.1 to Registrant’s Quarterly Report on Form 10-Q as filed with the Commission on December 10, 2018).
3.2Amended and Restated Bylaws of Avid Bioservices, Inc., a Delaware corporation (Incorporated by reference to Exhibit 3.2 to Registrant’s Current Report on Form 8-K as filed with the Commission on November 14, 2014).
3.3Amendment No. 1 to Amended and Restated Bylaws of Avid Bioservices, Inc., a Delaware corporation (Incorporated by reference to Exhibit 3.2 to Registrant’s Current Report on Form 8-K as filed with the Commission on March 13, 2018).
4.1Form of Certificate for Common Stock (Incorporated by reference to Exhibit 4.1 to Registrant’s Annual Report on Form 10-K for the year end April 30, 1988).
4.2Avid Bioservices, Inc. 2002 Non-Qualified Stock Option Plan (Incorporated by reference to Exhibit 4.17 to Registrant’s Registration Statement on Form S-8 (File No. 333-106385) as filed with the Commission on June 23, 2006). *
4.3Form of 2002 Non-Qualified Stock Option Agreement (Incorporated by reference to Exhibit 4.18 to Registrant’s Registration Statement on Form S-8 (File No. 333-106385) as filed with the Commission on June 23, 2006). *
4.4Amended and Restated Rights Agreement, dated March 16, 2016, between Avid Bioservices, Inc. and Broadridge Corporate Issuer Solutions, Inc., as Rights Agent (Incorporated by reference to Exhibit 4.1 to Registrant’s Current Report on Form 8-K as filed with the Commission on March 17, 2016).
4.52003 Stock Incentive Plan Non-qualified Stock Option Agreement (Incorporated by reference to Exhibit 10.95 to Registrant’s Registration Statement on Form S-8 (File No. 333-121334) as filed with the Commission on December 16, 2004).*
4.62003 Stock Incentive Plan Incentive Stock Option Agreement (Incorporated by reference to Exhibit 10.96 to Registrant’s Registration Statement on Form S-8 (File No. 333-121334) as filed with the Commission on December 16, 2004). *
4.72010 Stock Incentive Plan (Incorporated by reference to Exhibit A to Registrant’s Definitive Proxy Statement as filed with the Commission on August 27, 2010).*
4.8Form of Stock Option Award Agreement under 2010 Stock Incentive Plan (Incorporated by reference to Exhibit 4.17 to Registrant’s Registration Statement on Form S-8 (File No. 333-171067) as filed with the Commission on December 9, 2010). *
4.92010 Employee Stock Purchase Plan (Incorporated by reference to Exhibit B to Registrant’s Definitive Proxy Statement filed with the Commission on August 27, 2010). *
4.10Amendment to the 2010 Employee Stock Purchase Plan (Incorporated by reference to Exhibit B to Registrant’s Definitive Proxy Statement as filed with the Commission on August 26, 2016). *
4.112011 Stock Incentive Plan (Incorporated by reference to Exhibit A to Registrant’s Definitive Proxy Statement as filed with the Commission on August 26, 2011). *
4.12Form of Stock Option Award Agreement under 2011 Stock Incentive Plan (Incorporated by reference to Exhibit 4.20 to Registrant’s Registration Statement on Form S-8 (File No. 333-178452) as filed with the Commission on December 12, 2011). *
4.13First Amendment to the Avid Bioservices, Inc., 2011 Stock Incentive Plan (Incorporated by reference to Exhibit A to Registrant’s Definitive Proxy Statement as filed with the Commission on August 27, 2012). *
4.14Second Amendment to the Avid Bioservices, Inc. 2011 Stock Incentive Plan (Incorporated by reference to Exhibit A to Registrant’s Definitive Proxy Statement as filed with the Commission on August 26, 2013). *
4.15Third Amendment to the Avid Bioservices, Inc. 2011 Stock Incentive Plan dated April 24, 2015 (Incorporated by reference to Exhibit 4.24 to Registrant’s Annual Report on Form 10-K for the year ended April 30, 2015, as filed with the Commission on July 14, 2015). *
4.16Form of Amendment to Stock Option Award Agreement Under the Avid Bioservices, Inc., 2011 Stock Incentive Plan related to Non-Employee Director stock option awards (Incorporated by reference to Exhibit 4.27 to Registrant’s Annual Report on Form 10-K for the year ended April 30, 2015, as filed with the Commission on July 14, 2015).*

68

 

 

    Incorporated by Reference 

Exhibit

Number

 

 

Description

 

 

Form

 

Date

Filed

 

Exhibit

Number

 

Filed

Herewith

 
4.20* Form of Restricted Stock Unit Award Agreement under 2018 Omnibus Incentive Plan S-8 12/10/2018 4.3   
4.21 Description of Registrant’s Securities       X 
10.1 Lease and Agreement of Lease between TNCA, LLC, as Landlord, and Avid Bioservices, Inc., as Tenant, dated as of December 24, 1998 10-Q 3/12/1999 10.48   
10.2 First Amendment to Lease andAgreement of Lease between TNCA, LLC, as Landlord, and Avid Bioservices, Inc., as Tenant, dated December 22, 2005 8-K 12/23/2005 99.1  99.2   
10.3* Amended and Restated Employment Agreement by and between Avid Bioservices, Inc. and Mark R. Ziebell, effective December 27, 2012 10-Q 3/12/2013 10.38   
10.4** Asset Assignment and Purchase Agreement by and between Avid Bioservices, Inc. and Oncologie, Inc., dated February 12, 2018 10-K 7/16/2018 10.11   
10.5* Employment Agreement by and between Avid Bioservices, Inc. and Daniel R. Hart, effective June 26, 2019 10-K 6/27/2019 10.7   
10.6* Amendment to 2010 Employee Stock Purchase Plan DEF-14A 8/21/2019 A   
10.7 Promissory Note, dated April 17, 2020, by and between Avid Bioservices, Inc. and City National Bank 8-K 4/23/2020 10.1   
23.1 Consent of Independent Registered Public Accounting Firm       X 
24 Power of Attorney (included on signature page of Annual Report)       X 
31.1 Certification of Chief Executive Officer pursuant to Rule 13a-14(a)/15d-14(a) under the Securities Exchange Act of 1934, as amended       X 
31.2 Certification of Chief Financial Officer pursuant to Rule 13a-14(a)/15d-14(a) under the Securities Exchange Act of 1934, as amended       X 
32 

Certifications of Chief Executive Officer and Chief Financial Officer pursuant to Rule 13a-14(b)/15d-14(b) under the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350

       X 
101.INS XBRL Taxonomy Extension Instance Document       X 
101.SCH XBRL Taxonomy Extension Schema Document       X 
101.CAL XBRL Taxonomy Extension Calculation Linkbase Document       X 
101.DEF XBRL Taxonomy Extension Definition Linkbase Document       X 
101.LAB XBRL Taxonomy Extension Label Linkbase Document       X 
101.PRE XBRL Presentation Extension Linkbase Document       X 
              

Exhibit
Number

Description

4.17Fourth Amendment to the Avid Bioservices, Inc. 2011 Stock Incentive Plan (Incorporated by reference to Exhibit B to Registrant’s Definitive Proxy Statement filed with the Commission on August 28, 2015). *
4.18Form of Indenture (Incorporated by reference to Exhibit 4.4 to Registrant’s Registration Statement on Form S-3 (File No.: 333-222548) as filed with the Commission on January 12, 2018).
4.19Avid Bioservices, Inc. 2018 Omnibus Incentive Plan (Incorporated by reference to Exhibit A to Registrant’s Definitive Proxy Statement filed with the Commission on August 17, 2018). *
4.20Form of Stock Option Award Agreement under 2018 Omnibus Incentive Plan (Incorporated by reference to Exhibit 4.2 to Registrant’s Registration Statement on Form S-8 (File No. 333-228735) as filed with the Commission on December 10, 2018). *
4.21Form of Restricted Stock Unit Award Agreement under 2018 Omnibus Incentive Plan (Incorporated by reference to Exhibit 4.3 to Registrant’s Registration Statement on Form S-8 (File No. 333-228735) as filed with the Commission on December 10, 2018). *
10.1Lease and Agreement of Lease between TNCA, LLC, as Landlord, and Avid Bioservices, Inc., as Tenant, dated as of December 24, 1998 (Incorporated by reference to Exhibit 10.48 to Registrant’s Quarterly Report on Form 10-Q as filed with the Commission on March 12, 1999).
10.2First Amendment to Lease and Agreement of Lease between TNCA, LLC, as Landlord, and Avid Bioservices, Inc., as Tenant, dated December 22, 2005 (Incorporated by reference to Exhibit 99.1 and 99.2 to Registrant’s Current Report on Form 8-K as filed with the Commission on December 23, 2005).
10.3Annual Bonus Plan for Executive Officers adopted July 12, 2011(Incorporated by reference to Exhibit 10.29 to Registrant’s Annual Report on Form 10-K as filed with the Commission on July 14, 2011). *
10.4Amended and Restated Employment Agreement by and between Avid Bioservices, Inc. and Mark R. Ziebell, effective December 27, 2012 (Incorporated by reference to Exhibit 10.38 to Registrant’s Quarterly Report on Form 10-Q as filed with the Commission on March 12, 2013). *
10.5Asset Assignment and Purchase Agreement by and between Avid Bioservices, Inc. and Oncologie, Inc., dated February 12, 2018 (Incorporated by reference to Exhibit 10.11 to Registrant's Annual Report on Form 10-K as filed with the Commission on July 16, 2018). **
10.6Separation Agreement and Release of Claims between Roger J. Lias, Ph.D. and Avid Bioservices, Inc. dated June 12, 2019. ***
10.7Employment Agreement by and between Avid Bioservices, Inc. and Daniel R. Hart, effective June 26, 2019. (*) (***)
23.1Consent of Independent Registered Public Accounting Firm. ***
24Power of Attorney (included on signature page of Annual Report). ***
31.1Certification of Chief Executive Officer pursuant to Rule 13a-14(a)/15d-14(a) under the Securities Exchange Act of 1934, as amended. ***
31.2Certification of Chief Financial Officer pursuant to Rule 13a-14(a)/15d-14(a) under 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) under the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350. ***
101.INSXBRL Taxonomy Extension Instance Document. ***
101.SCHXBRL Taxonomy Extension Schema Document. ***
101.CALXBRL Taxonomy Extension Calculation Linkbase Document. ***
101.DEFXBRL Taxonomy Extension Definition Linkbase Document. ***
101.LABXBRL Taxonomy Extension Label Linkbase Document. ***
101.PREXBRL Presentation Extension Linkbase Document. ***
_______________________________

*

**

 

This Exhibit is a management contract or a compensation plan or arrangement.

**Portions omitted pursuant to a request of confidentiality filed separately with the SEC.
***

Filed herewith.

 

 

 

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SIGNATURES

 

Pursuant to the requirements of Section 13 or 15(d) 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.
  
Dated:Date: June 27, 201930, 2020By: /s/ /Richard B. Hancock
  

Richard B. Hancock
Interim President and Chief Executive Officer

(Principal Executive Officer)

 

POWER OF ATTORNEY

 

KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Richard B. Hancock, Interim President and Chief Executive Officer, and Daniel R. Hart, Chief Financial Officer, and each of them, his true and lawful attorneys-in-fact and agents, with the full power of substitution and re-substitution, for him and in his name, place and stead, in any and all capacities, to sign any amendments to this report, and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto each said attorney-in-fact and agent full power and authority to do and perform each and every act in person, hereby ratifying and confirming all that said attorney-in-fact and agent, or either of them, or their or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.

 

Pursuant to the requirements of the Securities Exchange Act of 1934, this Report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated:

 

Name Title Date
     
/s/ Richard B. Hancock Interim President and Chief Executive Officer and Director June 27, 201930, 2020
Richard B. Hancock (Principal Executive Officer)  
     
     
/s/ Daniel R. Hart Chief Financial Officer June 27, 201930, 2020
Daniel R. Hart (Principal Financial Officer and Principal Accounting Officer) 
     
     
/s/ Joseph Carleone, Ph.D. Chairman of the Board of Directors June 27, 201930, 2020
Joseph Carleone, Ph.D.    
     
     
/s/ Mark R. Bamforth Director June 27, 201930, 2020
Mark R. Bamforth    
     
     
/s/ Joel McCombCatherine J. Mackey, Ph.D. Director June 27, 201930, 2020
Joel McCombCatherine J. Mackey, Ph.D.    
     
     
/s/ Gregory P. Sargen Director June 27, 201930, 2020
Gregory P. Sargen    
     
     
/s/ Patrick D. Walsh Director June 27, 201930, 2020
Patrick D. Walsh    
     

 

 

 

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