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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
þQUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2024
or
¨
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
Commission File Number: 001-37507
_____________________________________
IMMUNITYBIO, INC.
(Exact name of registrant as specified in its charter)
_____________________________________
Delaware43-1979754
(State or other jurisdiction of
incorporation or organization)
(I.R.S. Employer
Identification No.)
3530 John Hopkins Court
San Diego, California
92121
(Address of principal executive offices)(Zip Code)
Registrant’s telephone number, including area code: (844) 696-5235
_____________________________________
Securities registered pursuant to Section 12(b) of the Act:
Title of each class Trading Symbol(s)Name of each exchange on which registered
Common Stock, par value $0.0001 per shareIBRXThe Nasdaq Global Select Market
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes þ No ¨
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 such files). Yes þ No ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
¨
Accelerated filer
¨
Non-accelerated filer
þ
Smaller reporting company
þ
Emerging growth company
¨
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No þ
The number of shares of the Registrant’s common stock outstanding as of August 7, 2024 was 696,533,418 (excluding 163,800 shares held by a majority owned subsidiary of ours which are treated as treasury shares for accounting purposes).



TABLE OF CONTENTS
Page
 
 
 
i


Defined Terms
Unless expressly indicated or the context required otherwise, the terms “ImmunityBio,” “the company,” “we,” “us,” and “our” in this Quarterly Report refer to ImmunityBio, Inc., a Delaware corporation, and, where appropriate, its subsidiaries. We have also used several other terms in this Quarterly Report, the unaudited condensed consolidated financial statements and accompanying notes included herein, most of which are defined below:
TermDefinition
2015 PlanImmunityBio, Inc. 2015 Equity Incentive Plan
3M IPC3M Innovative Properties Company
3PL Agentlogistics agent
AAHIAccess to Advanced Health Institute
ACAAffordable Care Act
AltorAltor BioScience, LLC
America Invents ActLeahy-Smith America Invents Act
AmyrisAmyris, Inc.
ANKTIVA®
Proprietary name for N-803 (formerly ALT-803), our novel IL-15 agonist complex
   (nogapendekin alfa inbakicept-pmln) currently approved for use in the United States
   with BCG for the treatment of adult patients with BCG-unresponsive non-muscle invasive
   bladder cancer with carcinoma in situ with or without papillary tumors, and currently in
   clinical development for other indications.
Annual ReportAnnual Report on Form 10-K for the year ended December 31, 2023
Approved productANKTIVA
ASCAccounting Standards Codification
ASUAccounting Standards Update
AthenexAthenex, Inc.
ATM“at-the-market” sales agreement
ATRAAmerican Taxpayer Relief Act of 2012
BCGBacillus Calmette-Guérin
BeikeShenzhen Beike Biotechnology Co. Ltd.
BLABiologics License Application
BPCIABiologics Price Competition and Innovation Act of 2009
BrinkBrink Biologics, Inc.
CambridgeCambridge Equities, LP
CCPACalifornia Consumer Privacy Act of 2018
CEOchief executive officer
CFOchief financial officer
cGMPcurrent Good Manufacturing Practice
Chinawhen used in connection with the RIPA, People’s Republic of China, Hong Kong and
   any territories controlled by the People’s Republic of China
CIScarcinoma in situ
ClinicImmuno-Oncology Clinic, Inc.
Closing Datewhen used in connection with the RIPA, December 29, 2023
CMCChemistry, Manufacturing and Controls
CMOcontract manufacturing organization
CMSCenters for Medicare & Medicaid Services
CodeInternal Revenue Code of 1986, as amended
ii


TermDefinition
CPRACalifornia Privacy Rights Act
CRLcomplete response letter
CROcontract research organization
CVRcontingent value right
DGCLDelaware General Corporation Law
Duley RoadDuley Road, LLC
Dunkirk Facilitya leasehold interest in a cGMP ISO Class 5 pharmaceutical manufacturing space in
   western New York
EMAEuropean Medicines Agency
EUEuropean Union
Exchange ActSecurities Exchange Act of 1934, as amended
ExyteExyte U.S., Inc.
FASBFinancial Accounting Standards Board
FCAFalse Claims Act
FCPAU.S. Foreign Corrupt Practices Act
FDAU.S. Food and Drug Administration
FIFOFirst In First Out inventory method
FSMCFort Schuyler Management Corporation, a not-for-profit corporation affiliated with the
   State of New York
FTOfreedom-to-operate
FVOfair value option
GBMglioblastoma multiforme
GCPGood Clinical Practice
GDPRGeneral Data Protection Regulation
GLPGood Laboratory Practice
GMPGood Manufacturing Practice
GTPGood Tissue Practice
hAd5human adenovirus serotype 5
Hatch-Waxman ActDrug Price Competition and Patent Term Restoration Act of 1984
HCWHCW Biologics, Inc.
HIPAAHealth Insurance Portability and Accountability Act of 1996
HITECHHealth Information Technology for Economic and Clinical Health Act
HIVhuman immunodeficiency virus
IgDraSolIgDraSol, Inc., a subsidiary of the company
INDinvestigational new drug
InfinityInfinity SA LLC, as purchaser agent for affiliates of Oberland
IPR&DIn-process research and development
IRAInflation Reduction Act of 2022
IRSInternal Revenue Service
LMIClow- and middle-income countries
mAbsmonoclonal antibodies
iii


TermDefinition
Nant CapitalNant Capital, LLC
NantBioNantBio, Inc.
NantCellNantCell, Inc., a subsidiary of the company
NANTibodyImmunotherapy NANTibody, LLC, a subsidiary of the company
NantKwestNantKwest, Inc.
NantPharmaNantPharma, LLC
NantWorksNantWorks, LLC, a related-party
NCCNNational Comprehensive Cancer Network
NCINational Cancer Institute
NCSCNantCancerStemCell, LLC
NDANew Drug Application
NEOnamed executive officer
NKnatural killer
NMIBCnon-muscle invasive bladder cancer
NOLnet operating loss
NSCLCnon-small cell lung cancer
OberlandOberland Capital Management LLC and its affiliates (including Purchasers as
   defined in the RIPA)
OFACU.S. Treasury Department’s Office of Foreign Assets Control
PHIProtected Health Information
PMApremarket approval
QMSRQuality Management System Regulation
QSRQuality System Regulation
Quarterly ReportQuarterly Report on Form 10-Q for the three and six months ended June 30, 2024
QUILTQUantitative Integrated Lifelong Trial
RDOregistered direct offering
REMSRisk Evaluation and Mitigation Strategy
RIPARevenue Interest Purchase Agreement
RSUrestricted stock unit
Sarbanes-OxleySarbanes-Oxley Act of 2002
saRNAself-amplifying RNA
SARS-CoV-2novel strain of the coronavirus (COVID-19)
SECU.S. Securities and Exchange Commission
Section 404Section 404 of the Sarbanes-Oxley Act of 2002
Securities ActSecurities Act of 1933, as amended
SorrentoSorrento Therapeutics, Inc.
SPOAStock Purchase and Option Agreement
TAAtumor-associated antigen
TCJATax Cuts and Jobs Act of 2017
iv


TermDefinition
TF Platformtissue factor-based fusion discovery platform
Term SOFRTerm Secured Overnight Financing Rate
Test Datewhen used in connection with the RIPA, December 31, 2029
TGF-βtransforming growth factor beta
TLRtoll-like receptor
U.S. GAAPaccounting principles generally accepted in the United States of America
UK GDPRUK Data Protection Act of 2018
USPTOU.S. Patent and Trademark Office
VBC HoldingsVBC Holdings, LLC, a subsidiary of the company
VIEvariable interest entity
VivaBioCellVivaBioCell, S.p.A., a wholly-owned subsidiary of VBC Holdings
v

PART I—FINANCIAL INFORMATION
ITEM 1.     FINANCIAL STATEMENTS.
ImmunityBio, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
June 30,
2024
December 31,
2023
(Unaudited)  
ASSETS  
Current assets:  
Cash and cash equivalents$130,104 $265,453 
Marketable securities87,875 1,009 
Accounts receivable, net1,033  
Inventories1,811  
Due from related parties1,027 2,019 
Prepaid expenses and other current assets (including amounts with related parties)20,980 25,603 
Total current assets242,830 294,084 
Marketable securities, noncurrent 891 
Property, plant and equipment, net141,956 146,082 
Intangible assets, net16,058 17,093 
Convertible note receivable7,004 6,879 
Operating lease right-of-use assets, net (including amounts with related parties)33,817 36,543 
Other assets (including amounts with related parties)2,660 2,880 
Total assets$444,325 $504,452 
LIABILITIES AND STOCKHOLDERS’ DEFICIT  
Current liabilities:  
Accounts payable$20,317 $9,195 
Accrued expenses and other liabilities35,344 42,708 
Due to related parties200 1,136 
Operating lease liabilities (including amounts with related parties)6,249 5,244 
Total current liabilities62,110 58,283 
Related-party nonconvertible note, net of discount (Note 11)
108,811 104,586 
Related-party convertible notes and accrued interest, net of discount (Note 11)
584,107 576,951 
Revenue interest liability (Note 10)
263,342 155,415 
Operating lease liabilities, less current portion (including amounts with related parties)36,427 39,942 
Derivative liabilities (Note 10) and (Note 11)
20,807 35,333 
Warrant liabilities65,395 118,770 
Other liabilities704 1,109 
Total liabilities1,141,703 1,090,389 
The accompanying notes are an integral part of these condensed consolidated financial statements.
1

ImmunityBio, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets (Continued)
(in thousands, except share and per share amounts)
June 30,
2024
December 31,
2023
(Unaudited)  
Commitments and contingencies (Note 8)
Stockholders’ deficit:  
Common stock, $0.0001 par value; 1,350,000,000 shares authorized
   as of June 30, 2024 and December 31, 2023; 691,793,169 and
   670,867,344 shares issued and outstanding as of June 30, 2024 and
   December 31, 2023, respectively; excluding treasury stock, 163,800 shares
   outstanding as of June 30, 2024 and December 31, 2023
$69 $67 
Additional paid-in capital2,531,909 2,374,620 
Accumulated deficit(3,230,357)(2,961,684)
Accumulated other comprehensive (loss) income(8)10 
Total ImmunityBio stockholders’ deficit(698,387)(586,987)
Noncontrolling interests1,009 1,050 
Total stockholders’ deficit(697,378)(585,937)
Total liabilities and stockholders’ deficit$444,325 $504,452 
The accompanying notes are an integral part of these condensed consolidated financial statements.
2

ImmunityBio, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(Unaudited)
Three Months Ended
June 30,
Six Months Ended
June 30,
2024202320242023
Revenue
Product revenue, net$990 $ $990 $ 
Other revenues57 41 97 401 
Total revenue1,047 41 1,087 401 
Operating costs and expenses
Cost of product revenue    
Research and development (including amounts
   with related parties)
51,129 53,168 104,480 132,432 
Selling, general and administrative (including amounts
   with related parties)
49,251 32,018 91,136 64,694 
Total operating costs and expenses100,380 85,186 195,616 197,126 
Loss from operations(99,333)(85,145)(194,529)(196,725)
Other income (expense), net   
Interest and investment income (loss), net1,891 (61)4,990 612 
Interest expense (including amounts with related parties)(29,794)(32,235)(59,277)(62,051)
Change in fair value of derivative liabilities21,194  18,470  
Change in fair value of warrant liabilities(19,300)(10,019)(21,102)17,535 
Interest expense related to revenue interest liability(9,225) (17,229) 
Change in fair value of related-party convertible note (6,768) (6,768)
Loss on equity method investment (3,957) (6,294)
Other expense, net (including amounts
   with related parties)
(17)(28)(37)(1,105)
Total other expense, net(35,251)(53,068)(74,185)(58,071)
Loss before income taxes and noncontrolling interests(134,584)(138,213)(268,714)(254,796)
Income tax expense    
Net loss(134,584)(138,213)(268,714)(254,796)
Net loss attributable to noncontrolling interests, net of tax(20)(334)(41)(574)
Net loss attributable to ImmunityBio common stockholders$(134,564)$(137,879)$(268,673)$(254,222)
Net loss per ImmunityBio common share – basic and diluted$(0.20)$(0.32)$(0.40)$(0.59)
Weighted-average number of common shares used in computing
   net loss per share – basic and diluted
686,938,120 437,456,657 679,884,678 432,944,133 
The accompanying notes are an integral part of these condensed consolidated financial statements.
3

ImmunityBio, Inc. and Subsidiaries
Condensed Consolidated Statements of Comprehensive Loss
(in thousands)
(Unaudited)
Three Months Ended
June 30,
Six Months Ended
June 30,
2024202320242023
Net loss$(134,584)$(138,213)$(268,714)$(254,796)
Other comprehensive loss, net of income taxes:
Net unrealized gains (losses) on available-for-sale securities9 (6)(8)(2)
Reclassification of net realized (gains) losses on
   available-for-sale securities included in net loss
(4) 45 6 
Foreign currency translation adjustments(6)(1)(55)(227)
Total other comprehensive loss(1)(7)(18)(223)
Comprehensive loss(134,585)(138,220)(268,732)(255,019)
Less: Comprehensive loss attributable to noncontrolling interests20 334 41 574 
Comprehensive loss attributable to ImmunityBio
   common stockholders
$(134,565)$(137,886)$(268,691)$(254,445)
The accompanying notes are an integral part of these condensed consolidated financial statements.
4

ImmunityBio, Inc. and Subsidiaries
Condensed Consolidated Statements of Stockholders’ Deficit
(in thousands, except share amounts)
(Unaudited)
Six Months Ended June 30, 2024
Common Stock
Additional
Paid-in
Capital
Accumulated
Deficit
Accumulated
Other
Comprehensive
Income (Loss)
Total
ImmunityBio
Stockholders’
Deficit
Noncontrolling
Interests
Total
Stockholders’
Deficit
SharesAmount
Balance as of December 31, 2023
670,867,344 $67 $2,374,620 $(2,961,684)$10 $(586,987)$1,050 $(585,937)
Stock-based compensation expense— — 8,266 — — 8,266 — 8,266 
Vesting of RSUs
2,969,156 — — — — — — — 
Net share settlement for RSUs vesting
(1,117,737)— (3,867)— — (3,867)— (3,867)
Exercise of warrants4,284,648 1 24,701 — — 24,702 — 24,702 
Other comprehensive loss, net of tax
— — — — (17)(17)— (17)
Net loss— — — (134,109)— (134,109)(21)(134,130)
Balance as of March 31, 2024
677,003,411 68 2,403,720 (3,095,793)(7)(692,012)1,029 (690,983)
Issuance of common stock “at-the-market”
   offering, net of commissions and
   offering costs of $660
427,368 — 3,625 — — 3,625 — 3,625 
Stock-based compensation expense
— — 9,639 — — 9,639 — 9,639 
Exercise of stock options146,199 — 429 — — 429 — 429 
Vesting of RSUs
222,578 — — — — — — — 
Net share settlement for RSUs vesting
(83,220)— (496)— — (496)— (496)
Exercise of warrants13,217,843 1 107,438 — — 107,439 — 107,439 
Exercise of Oberland stock option, net of commissions of $150
858,990 — 7,554 — — 7,554 — 7,554 
Other comprehensive loss, net of tax
— — — — (1)(1)— (1)
Net loss— — — (134,564)— (134,564)(20)(134,584)
Balance as of June 30, 2024
691,793,169 $69 $2,531,909 $(3,230,357)$(8)$(698,387)$1,009 $(697,378)
The accompanying notes are an integral part of these condensed consolidated financial statements.
5

ImmunityBio, Inc. and Subsidiaries
Condensed Consolidated Statements of Stockholders’ Deficit (Continued)
(in thousands, except share amounts)
(Unaudited)
Six Months Ended June 30, 2023
Common Stock
Additional
Paid-in
Capital
Accumulated
Deficit
Accumulated
Other
Comprehensive
Income (Loss)
Total
ImmunityBio
Stockholders’
Deficit
Noncontrolling
Interests
Total
Stockholders’
Deficit
SharesAmount
Balance as of December 31, 2022
421,569,115 $42 $1,930,936 $(2,378,488)$183 $(447,327)$(2,493)$(449,820)
Issuance of shares in an RDO, net of discount and
   offering costs of $2,046 and value ascribed
   to associated warrants
14,072,615 1 24,255 — — 24,256 — 24,256 
Stock-based compensation expense— — 10,878 — — 10,878 — 10,878 
Exercise of stock options81,037 — 126 — — 126 — 126 
Vesting of RSUs313,975 — — — — — — — 
Net share settlement for RSUs vesting(113,638)— (357)— — (357)— (357)
Other comprehensive loss, net of tax— — — — (216)(216)— (216)
Net loss— — — (116,343)— (116,343)(240)(116,583)
Balance as of March 31, 2023
435,923,104 43 1,965,838 (2,494,831)(33)(528,983)(2,733)(531,716)
Issuance of common stock “at-the-market”
   offering, net of commissions and
   offering costs of $313
4,605,323 1 13,615 — — 13,616 — 13,616 
Stock-based compensation expense
— — 11,062 — — 11,062 — 11,062 
Exercise of stock options26,583 — 135 — — 135 — 135 
Vesting of RSUs
140,269 — — — — — — — 
Net share settlement for RSUs vesting
(21,382)— (60)— — (60)— (60)
Other comprehensive loss, net of tax
— — — — (7)(7)— (7)
Net loss— — — (137,879)— (137,879)(334)(138,213)
Balance as of June 30, 2023
440,673,897 $44 $1,990,590 $(2,632,710)$(40)$(642,116)$(3,067)$(645,183)
The accompanying notes are an integral part of these condensed consolidated financial statements.
6

ImmunityBio, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows
(in thousands)
(Unaudited)
 Six Months Ended
June 30,
 20242023
Operating activities: 
Net loss$(268,714)$(254,796)
Adjustments to reconcile net loss to net cash used in operating activities:
Change in fair value of warrant liabilities21,102 (17,535)
Change in fair value of derivative liabilities(18,470) 
Stock-based compensation expense17,905 21,940 
Non-cash interest expense related to the revenue interest liability17,211  
Amortization of related-party notes discounts11,381 23,824 
Depreciation and amortization8,961 9,363 
Non-cash lease expense related to operating lease right-of-use assets2,726 3,233 
Accretion of discounts on marketable debt securities(885) 
Non-cash interest items, net (including amounts with related parties)(125)5,026 
Unrealized losses on equity securities15 258 
Change in fair value of convertible note 6,768 
Transaction costs allocated to warrant liabilities 984 
Other94 123 
Changes in operating assets and liabilities:
Accounts receivable(1,033) 
Inventories(1,811) 
Prepaid expenses and other current assets3,148 11,240 
Other assets181 1,047 
Accounts payable8,969 (869)
Accrued expenses and other liabilities(5,620)27,864 
Related parties56 (1,232)
Operating lease liabilities(2,420)(1,321)
Net cash used in operating activities
(207,329)(164,083)
Investing activities:
Purchases of marketable debt securities, available-for-sale(134,129)(236)
Maturities of marketable debt securities, available-for-sale48,021  
Proceeds from sales of marketable debt securities981 102 
Purchases of property, plant and equipment(1,985)(16,954)
Net cash used in investing activities
(87,112)(17,088)
The accompanying notes are an integral part of these condensed consolidated financial statements.
7

ImmunityBio, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows (Continued)
(in thousands)
(Unaudited)
 Six Months Ended
June 30,
 20242023
Financing activities:
Proceeds from the RIPA, net of issuance costs$96,956 $ 
Proceeds from exercises of warrants57,664  
Proceeds from exercise of Oberland stock option, net of commissions4,850  
Net share settlement for RSUs vesting(4,363)(417)
Proceeds from equity offerings, net of discounts and issuance costs3,625 60,794 
Proceeds from exercises of stock options429 261 
Principal payments of finance leases(42)(38)
Proceeds from issuance of related-party promissory notes, net of issuance costs paid 59,700 
Net cash provided by financing activities
159,119 120,300 
Effect of exchange rate changes on cash, cash equivalents, and restricted cash(27)(264)
Net change in cash, cash equivalents, and restricted cash(135,349)(61,135)
Cash, cash equivalents, and restricted cash, beginning of period265,787 104,965 
Cash, cash equivalents, and restricted cash, end of period$130,438 $43,830 
The accompanying notes are an integral part of these condensed consolidated financial statements.
8

ImmunityBio, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows (Continued)
(in thousands)
(Unaudited)
 Six Months Ended
June 30,
 20242023
Reconciliation of cash, cash equivalents, and restricted cash, end of period:  
Cash and cash equivalents$130,104 $43,506 
Restricted cash 334 324 
Cash, cash equivalents, and restricted cash, end of period$130,438 $43,830 
Supplemental disclosure of cash flow information:  
Cash paid during the period for:  
Interest$47,891 $25,520 
Income taxes$13 $ 
Supplemental disclosure of non-cash activities:  
Property and equipment purchases included in accounts payable,
   accrued expenses and due to related parties
$2,995 $11,992 
Unrealized gains on marketable debt securities, net$37 $4 
Initial measurement of warrants issued in connection with
   RDOs accounted for as liabilities
$ $23,698 
Unpaid offering costs included in accounts payable and accrued expenses$ $208 
The accompanying notes are an integral part of these condensed consolidated financial statements.
9

ImmunityBio, Inc. and Subsidiaries
Notes to Unaudited Condensed Consolidated Financial Statements
1.    Description of Business
In these notes to unaudited condensed consolidated financial statements, the terms “ImmunityBio,” “the company,” “we,” “us,” and “our” refer to ImmunityBio, Inc. and its subsidiaries.
Our Business
ImmunityBio is a vertically-integrated biotechnology company developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases. The company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. We are applying our science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases.
Our platforms and their associated product and product candidates are designed to attack cancer and infectious pathogens by activating both the innate immune system, including—NK cells, dendritic cells, and macrophages, as well as—the adaptive immune system comprising—B and T cells,—in an orchestrated manner. The goal of this potentially best-in-class approach is to generate immunogenic cell death thereby eliminating rogue cells from the body whether they are cancerous or virally-infected. Our ultimate goal is to overcome the limitations of current treatments, such as checkpoint inhibitors, and/or reduce the need for standard high-dose chemotherapy in cancer by employing this coordinated approach to establish “immunological memory” that confers long-term benefit for the patient.
Our proprietary platforms for the development of biologic product candidates include: (i) antibody-cytokine fusion proteins, (ii) DNA, RNA, and recombinant protein vaccines, and (iii) cell therapies. As of June 2024, our platforms have generated nine first-in-human therapeutic agents (including one FDA-approved agent) that are currently or planned to be studied in clinical trials in liquid and solid tumors. Specifically, our clinical focus includes bladder, lung, and colorectal cancers and GBM, which are among the most frequent and lethal cancer types, and where there are high failure rates for existing standards of care or no available effective treatment.
Our lead biologic product ANKTIVA is a novel first-in-class IL-15 agonist antibody-cytokine fusion protein. On April 22, 2024, the FDA approved our product, ANKTIVA with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors (the “approved product”). We began commercial distribution of our approved product in May 2024.
2.    Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. GAAP and pursuant to the rules and regulations of the SEC. The unaudited condensed consolidated financial statements reflect all adjustments which are, in the opinion of management, necessary for a fair presentation of our financial position and results of operations. Certain items in the prior year’s consolidated financial statements have been reclassified to conform to the current presentation. These reclassifications had no effect on the reported results of operations. The unaudited condensed consolidated financial statements do not include all information and notes required by U.S. GAAP for annual reports and therefore should be read in conjunction with our consolidated financial statements and the notes thereto contained in our Annual Report filed with the SEC on March 19, 2024. These interim financials are not necessarily indicative of results expected for the full fiscal year.
10

Principles of Consolidation
The accompanying unaudited condensed consolidated financial statements include the accounts of the company, its wholly-owned subsidiaries, and a VIE for which the company is the primary beneficiary. Any material intercompany transactions and balances have been eliminated upon consolidation. For consolidated entities where we have less than 100% of ownership, we record net loss attributable to noncontrolling interests, net of tax, on the condensed consolidated statement of operations equal to the percentage of the ownership interest retained in such entities by the respective noncontrolling parties.
We assess whether we are the primary beneficiary of a VIE at the inception of the arrangement and at each reporting date. This assessment is based on our power to direct the activities of the VIE that most significantly impact the VIE’s economic performance and our obligation to absorb losses or the right to receive benefits from the VIE that could potentially be significant to the VIE.
If the entity is within the scope of the variable interest model and meets the definition of a VIE, we consider whether we must consolidate the VIE or provide additional disclosures regarding our involvement with the VIE. If we determine that we are the primary beneficiary of the VIE, we will consolidate the VIE. This analysis is performed at the initial investment in the entity or upon any reconsideration event.
For entities we hold as an equity investment that are not consolidated under the VIE model, we consider whether our investment constitutes a controlling financial interest in the entity and therefore should be considered for consolidation under the voting interest model.
Liquidity
As of June 30, 2024, the company had an accumulated deficit of $3.2 billion. We also had negative cash flows from operations of $207.3 million during the six months ended June 30, 2024. The company will likely need additional capital to commercialize our approved product, and to further fund the development of, and to seek regulatory approvals for, our other product candidates.
The condensed consolidated 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, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or amounts and classification of liabilities that may result from the outcome of the uncertainty of our ability to continue as a going concern. As a result of continuing anticipated operating cash outflows as we commercialize our approved product and accelerate our development efforts, we believe that substantial doubt exists regarding our ability to continue as a going concern without additional funding or financial support. However, we believe our existing cash, cash equivalents, and investments in marketable securities; sales of our approved product; capital to be raised through equity offerings, including but not limited to, the offering, issuance and sale by us of our common stock under the ATM, of which we had $296.5 million available for future issuance as of June 30, 2024; and our potential ability to borrow from affiliated entities will be sufficient to fund our operations through at least the next 12 months following the issuance date of the consolidated financial statements based primarily upon our Executive Chairman and Global Chief Scientific and Medical Officer’s intent and ability to support our operations with additional funds, including loans from affiliated entities, as required, which we believe alleviates such doubt.
In addition to funds from the future sales of our approved product, which we expect to take time to establish, we may also seek to sell additional equity, through one or more follow-on offerings, or in separate financings, or obtain incremental subordinated debt in compliance with our existing revenue interest liability. However, we may not be able to secure such external financing in a timely manner or on favorable terms. Without significant sales of our approved product or additional funds, we may choose to delay or reduce our operating or investment expenditures. Further, because of the risk and uncertainties associated with the commercialization of our approved product and our other product candidates, we may need additional funds to meet our needs sooner than planned.
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Use of Estimates
The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, we evaluate our estimates, including those related to the valuation of equity-based awards, deferred income taxes and related valuation allowances, preclinical and clinical trial accruals, impairment assessments, CVR measurement and assessments, the measurement of right-of-use assets and lease liabilities, useful lives of long-lived assets, loss contingencies, fair value calculation of warrants, stock options, derivative liabilities, and convertible promissory notes, fair value measurements, revenue interest liability, revenue recognition, accruals for research and development activities, and the assessment of our ability to fund our operations for at least the next 12 months from the date of issuance of these condensed consolidated financial statements. We base our estimates on historical experience and on various other market-specific and relevant assumptions that we believe to be reasonable under the circumstances. Estimates are assessed each period and updated to reflect current information and anticipated future events, and accordingly, actual results may ultimately differ materially from those estimates.
Significant Accounting Policies
Our significant accounting policies are described in Note 2, Summary of Significant Accounting Policies, of the “Notes to Consolidated Financial Statements” that appears in Part II, Item 8. “Financial Statements and Supplementary Data” of our Annual Report filed with the SEC on March 19, 2024, except as updated herein or as it relates to revenue recognition, cost of revenue, accounts receivable, inventory, warrants, convertible notes, debt, revenue interest liability, derivative liabilities and the adoption of new accounting standards during the six months ended June 30, 2024. Management does not believe that any recently issued, but not yet effective, accounting pronouncements, if currently adopted, would have a material effect on the company’s consolidated financial statements.
Revenues
Product Sales
After FDA approval in April 2024, the company began recognizing revenue from the sale of ANKTIVA in accordance with ASC Topic 606, Revenue from Contracts with Customers (ASC 606). Revenue from product sales is recorded at the net sales price (“transaction price”), which includes an estimate of variable consideration. An estimate of variable consideration is based on an amount that reflects the consideration to which we expect to be entitled, net of accruals for estimated rebates, chargebacks, discounts and other deductions and returns established at the time of sale.
Where appropriate, these estimates are based on factors such as industry data and forecasted customer buying and payment patterns, our experience, current contractual and statutory requirements, specific known market events and trends. These reductions to gross sales reflect our best estimates of the amount of consideration to which we are entitled based on the terms of the contract. Variable consideration is included in the transaction price 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. Actual amounts of consideration ultimately received may differ from our estimates. If actual results in future periods vary from our estimates, we adjust these estimates, which would affect product revenue and earnings in the period such variances become known. As we gain more experience, estimates will be more heavily based on the expected utilization from historical data we have accumulated since the ANKTIVA product launch.
The company entered into a third-party logistics agreement to engage a 3PL Agent to distribute the company’s products to its customers. The 3PL Agent provides services to the company that include storage, shipping and distribution, processing product returns, as well as customer service, order to cash, and logistics support. The company’s customers are currently limited to pharmaceutical specialty distributors (each a “Customer”) pursuant to a drop-ship arrangement whereby the 3PL Agent will ship products to end customers of such Customers. Our Customers subsequently sell ANKTIVA to hospitals, medical facilities, physician practices, pharmacies and government agencies. Revenue from product sales is recognized when our performance obligations are satisfied, which is upon delivery to the end customer.
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Other Revenues
Prior to the approval of ANKTIVA for commercial sale, we primarily generated revenues from non-exclusive license agreements related to our cell lines, the sale of our bioreactors and related consumables, and grant programs. The company expects to continue to generate revenue from these programs.
License Agreements with Third Parties
The company has nonexclusive license agreements with a limited number of pharmaceutical and biotechnology companies that grant them the right to use our cell lines and intellectual property for non-clinical use. These agreements generally include upfront fees and annual research license fees for such use, as well as commercial license fees for sales of the licensee products developed or manufactured using our intellectual property and cell lines.
Under our license agreements with customers, we typically promise to provide a license to use certain cell lines and related patents, the related know-how, and future research and development data that affect the license. We have concluded that these promises represent one performance obligation due to the highly interrelated nature of the promises. We provide the cell lines and know-how immediately upon entering into the contracts. Research and development data are provided throughout the term of the contract when and if available. A performance obligation is a promise in a contract to transfer a distinct good or service to the customer. A contract’s transaction price is allocated to each distinct performance obligation based on relative standalone selling price and recognized as revenue when, or as, the performance obligation is satisfied.
Our license agreements may include non-refundable upfront payments, event-based milestone payments, sales-based royalty payments, or some combination of these. The event-based milestone payments represent variable consideration and we use the most likely amount method to estimate this variable consideration. Given the high degree of uncertainly around the achievement of these milestones, we do not recognize revenue from these milestone payments until the uncertainty associated with these payments is resolved. We currently estimate variable consideration related to milestone payments to be zero and, as such, no revenue has been recognized for milestone payments. We recognize revenue from sales-based royalty payments when or as sales occur. On a quarterly basis, we re-evaluate our estimate of milestone variable consideration to determine whether any amount should be included in the transaction price and recorded in revenue prospectively.
Other Product and Services Revenue
We sell our proprietary GMP-in-a-Box bioreactors and related consumables to affiliated companies and third parties. The arrangements typically include delivery of bioreactors, consumables, and providing installation service and perpetual software licenses for using the equipment. We recognize revenue when customers obtain control and can benefit from the promised goods or services, generally upon installation of the bioreactors, in an amount that reflects the consideration that we expect to receive in exchange for those goods or services. Upfront payments and fees are recorded as deferred revenue upon receipt and recognized as revenue when we satisfy our performance obligations under these arrangements.
Grant Revenue
Grant revenue is typically paid for reimbursable costs incurred over the duration of the associated research project or clinical trial and is recognized either when expenses reimbursable under the grants have been incurred and payments under the grants become contractually due or when cash is received, depending on the certainty of payment and other factors specific to each grant.
Cost of Product Revenue
Cost of product revenue consists primarily of third-party manufacturing costs, distribution, and overhead costs related to sales of approved product subsequent to receiving regulatory approval. Cost of product revenue may also include costs related to excess or obsolete inventory adjustment charges, abnormal costs, unabsorbed manufacturing and overhead costs, and manufacturing variances. Based on our policy to expense costs associated with the manufacture of products prior to receiving regulatory approval, all costs associated with the production of ANKTIVA were expensed in research and development expense, on the condensed consolidated statement of operations in the period incurred and therefore are not reflected in cost of product revenue.
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Accounts Receivable, Net
Accounts receivable is recorded net of allowances for prompt payment discounts, returns, and credit losses. The company estimates an allowance for credit losses by considering factors such as credit quality, the age of the accounts receivable balances, and current economic conditions that may affect a customer’s ability to pay. As of June 30, 2024, the credit profile for the company’s counterparty was deemed to be in good standing, and as such an allowance for credit losses was not recorded.
Inventory
We began to capitalize inventory costs associated with ANKTIVA during the three months ended June 30, 2024 after receiving FDA approval in April 2024 when it was determined that the inventory had a probable future economic benefit.
Inventory is stated at the lower of cost or estimated net realizable value with cost determined using the FIFO method. Inventory costs include the cost of materials, third-party contract manufacturing, third-party packaging services, freight, labor costs for personnel involved in the manufacturing process, and indirect overhead costs. Net realizable value is the estimated selling price in the ordinary course of business less reasonably predictable costs of completion, disposal and transportation.
The company performs an assessment of the recoverability of capitalized inventory during each reporting period, and it writes down any excess and obsolete inventories to their estimated net realizable value in the period in which the impairment is first identified. Such impairment charges, if they occur, are recorded in cost of product revenue, on the condensed consolidated statement of operations.
Because FDA approval was recently received and the company capitalized its first inventory as of June 30, 2024, no reserve has been established. The company will continue to monitor if a reserve is needed at each reporting period.
Warrants
The company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in ASC Topic 480, Distinguishing Liabilities from Equity (ASC 480), and ASC Topic 815, Derivatives and Hedging (ASC 815). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the company’s own stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the company’s control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding.
For warrants that meet all criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital, on the condensed consolidated statement of stockholders’ deficit at the time of issuance. For warrants that do not meet all the criteria for equity classification, the warrants are required to be recorded at their initial fair value on the date of issuance, and on each balance sheet date thereafter. Changes in the estimated fair value of the warrants are recorded as a non-cash gain or loss in other income (expense), net, on the condensed consolidated statement of operations. The fair value of the warrants was estimated using the Black-Scholes option pricing model.
Fair Value Option Election
The company accounted for a convertible note issued on March 31, 2023 under the FVO election of ASC Topic 825, Financial Instruments (ASC 825) until it was amended and restated on December 29, 2023. Prior to its extinguishment on December 29, 2023, the convertible note was a debt host financial instrument containing embedded features wherein the entire financial instrument was initially measured at its issuance-date fair value and then subsequently remeasured at estimated fair value on a recurring basis at each reporting period date.
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Changes in the estimated fair value of this convertible note were recorded in other (expense) income, net, on the condensed consolidated statement of operations, except that changes in estimated fair value caused by changes in the instrument-specific credit risk are included in other comprehensive income (loss). In accordance with FASB ASC Topic 470-50, Debt – Modifications and Extinguishments (ASC 470-50), when the convertible note was extinguished on December 29, 2023, the cumulative amount previously recorded in other comprehensive (loss) income resulting from changes in the instrument-specific credit risk were reclassified and reported in current earnings on the condensed consolidated statement of operations. See Note 11, Related-Party Debt, for more information.
Debt Modification and Extinguishment
The company evaluates amendments to its debt instruments in accordance with ASC 470-50. This evaluation includes comparing (1) if applicable, the net present value of future cash flows of the amended debt to that of the original debt and (2) the change in fair value of an embedded conversion feature to that of the carrying amount of the debt immediately prior to amendment to determine, in each case, if a change greater than 10% occurred. In instances where the net present value of future cash flows or the fair value of an embedded conversion feature, if any, changed more than 10%, the company applies extinguishment accounting. In instances where the net present value of future cash flows and the fair value of an embedded conversion feature, if any, changed less than 10%, the company accounts for the amendment to the debt as a debt modification. Gains and losses on debt amendments that are considered extinguishments are recognized in current earnings or in additional paid-in capital if the transactions are with entities under common control. Debt amendments that are considered debt modifications are accounted for prospectively through yield adjustments, based on the revised terms. The increase in fair value of the embedded conversion feature from the debt modification was accounted for as an increase in debt discount with a corresponding increase in additional paid-in capital. Legal fees and other costs incurred with third parties that are directly related to debt modifications are expensed as incurred. Amounts paid by the company to the lenders, are reflected as additional debt discount and amortized as an adjustment of interest expense over remaining term of modified debt using the effective interest method.
Revenue Interest Liability
On December 29, 2023, we entered into the RIPA with Infinity and Oberland. Pursuant to the RIPA, Oberland acquired certain Revenue Interests (as defined in the RIPA) from us for a gross purchase price of $200.0 million paid on closing and acquired additional Revenue Interests from us for a gross purchase price of $100.0 million paid on May 13, 2024. Under the RIPA, Oberland has the right to receive quarterly payments from us based on, among other things, a certain percentage of our worldwide net sales, excluding those in China, during such quarter. The RIPA is considered a sale of future revenues and is accounted for as a liability net of a debt discount comprised of deferred issuance costs, the fair value of a freestanding option agreement related to the SPOA, and the fair value of embedded derivatives requiring bifurcation on the consolidated balance sheet. The company imputes interest expense associated with this liability using the effective interest rate method. The effective interest rate is calculated based on the rate that would enable the debt to be repaid in full over the anticipated life of the arrangement. Interest expense is recognized over the estimated term on the consolidated statement of operations. The interest rate on this liability may vary during the term of the agreement depending on a number of factors, including the level of actual and forecasted net sales. The company evaluates the interest rate quarterly based on actual and forecasted net sales utilizing the prospective method. A significant increase or decrease in actual or forecasted net sales will materially impact the revenue interest liability, interest expense, and the time period for repayment.
Derivative Liabilities
Embedded derivatives that are required to be bifurcated from the underlying debt instrument that do not meet the derivative scope exception and equity classification criteria are accounted for and valued as separate financial instruments. The terms of an embedded derivative related to a contingent exercisable prepayment feature of a convertible note have been evaluated and deemed to require bifurcation. This embedded derivative was initially measured at fair value and will be remeasured to fair value at each reporting date until the derivative is settled.
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In addition, the RIPA contains certain features that meet the definition of being an embedded derivative requiring bifurcation as a separate compound financial instrument apart from the RIPA. In May 2024, Oberland acquired additional Revenue Interests for a gross purchase price of $100.0 million, and the company recorded an incremental portion of the fair value of the derivative liability as of the funding date of $6.2 million as a debt discount, which is being amortized in interest expense, on the condensed consolidated statement of operations along with the initial debt discount over the expected term of the debt using the effective interest rate method. The fair value of the derivative liability is subject to remeasurement at each reporting period, with changes in fair value recognized in other income (expense), net, on the condensed consolidated statement of operations.
Basic and Diluted Net Loss per Share of Common Stock
Basic net loss per share is calculated by dividing the net loss attributable to ImmunityBio common stockholders by the weighted-average number of common shares outstanding for the period. Diluted loss per share is computed by dividing net loss attributable to ImmunityBio common stockholders by the weighted-average number of common shares, including the number of additional shares that would have been outstanding if the potential common shares had been issued and if the additional common shares were dilutive.
For all periods presented, potentially dilutive securities are excluded from the computation of fully diluted loss per share as their effect is anti-dilutive. The following table details the number of shares of common stock underlying those securities that have been excluded from the computation of potentially dilutive securities:
As of June 30,
20242023
(Unaudited)
Related-party convertible notes162,471,837 60,340,936 
Outstanding third-party warrants20,230,329 23,163,524 
Outstanding stock options15,714,486 10,002,722 
Outstanding RSUs6,444,196 6,029,582 
Outstanding related-party warrants1,638,000 1,638,000 
Total206,498,848 101,174,764 
The dilutive securities shown in the table above as of June 30, 2024 exclude an option to purchase up to approximately $5.0 million of the company’s common stock pursuant to the SPOA entered in connection with the RIPA, as the exercise price cannot be determined until the date of exercise.
Recent Accounting Pronouncements
Application of New or Revised Accounting Standards – Adopted
In June 2022, the FASB, issued ASU 2022-03, Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions, which clarifies that a contractual restriction on the sale of an equity security is not considered part of the unit of account of the equity security and, therefore, is not considered in measuring fair value. This ASU also clarifies that an entity cannot, as a separate unit of account, recognize and measure a contractual sale restriction and introduces certain disclosure requirements for equity securities subject to such restrictions. We adopted this ASU on January 1, 2024 on a prospective basis with no impact on our condensed consolidated financial statements.
In March 2023, the FASB issued ASU 2023-01, Leases-Common Control Arrangements (Topic 842). This ASU provides updated guidance for accounting for leasehold improvements associated with common control leases. We adopted this ASU on January 1, 2024 on a prospective basis with no impact on our condensed consolidated financial statements.
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Application of New or Revised Accounting Standards – Not Yet Adopted
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, to improve its income tax disclosure requirements. Under the ASU, entities must annually (1) disclose specific categories in the rate reconciliation, (2) provide additional information for reconciling items that meet a quantitative threshold, and (3) disclose more detailed information about income taxes paid, including by jurisdiction; pretax income (or loss) from continuing operations; and income tax expense (or benefit). The ASU is effective for fiscal years beginning after December 15, 2024, and interim periods beginning after December 15, 2025, with early adoption permitted. We are currently evaluating the impact of this standard on our disclosures.
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires disclosure of incremental segment information on an annual and interim basis. This ASU is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024 on a retrospective basis. We are currently evaluating the impact of this standard on our disclosures.
In August 2023, the FASB issued ASU 2023-05, Business Combinations-Joint Venture Formations (Subtopic 805-60): Recognition and Initial Measurement, which requires a joint venture to initially measure all contributions received upon its formation at fair value. This ASU is applicable to joint venture entities with a formation date on or after January 1, 2025 on a prospective basis. We will apply this guidance prospectively in future reporting periods after the guidance is effective to any future arrangements meeting the definition of a joint venture.
Other recent authoritative guidance issued by the FASB (including technical corrections to the ASC), and the SEC during the six months ended June 30, 2024 did not, or are not expected to, have a material effect on our condensed consolidated financial statements.
3.    Revenues
As discussed in Note 2, Summary of Significant Accounting Policies, revenues are recognized in accordance with ASC 606. The following table presents our disaggregated revenue for the periods presented (in thousands):
Three Months Ended
June 30,
Six Months Ended
June 30,
2024202320242023
(Unaudited)(Unaudited)
Product revenue, net$990 $ $990 $ 
Other revenues57 41 97 401 
Total revenue$1,047 $41 $1,087 $401 
Product Revenue, Net
During the three months ended June 30, 2024, our only source of product revenue has been from U.S. sales of ANKTIVA, which we began shipping to customers in May 2024.
As of June 30, 2024, approximately $49 thousand of gross-to-net accruals have been recorded as a reduction to revenue, of which approximately $5 thousand as a reduction of accounts receivable, net and approximately $44 thousand is presented in accrued expenses and other current liabilities on the condensed consolidated balance sheet.
Other Revenues
During the three and six months ended June 30, 2024, our primary source of other revenues was consumable product sales.
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4.    Financial Statement Details
Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consist of the following (in thousands):
June 30,
2024
December 31,
2023
(Unaudited)
Prepaid research and development costs$8,695 $7,847 
Prepaid services4,168 5,869 
Prepaid software license fees3,227 2,100 
Prepaid insurance1,428 2,242 
Prepaid rent1,254 1,113 
Prepaid equipment maintenance1,253 1,183 
ERP system implementation cost475 1,087 
Insurance premium financing asset 1,475 
Insurance claims receivable 1,149 
Other480 1,538 
Prepaid expenses and other current assets$20,980 $25,603 
Inventories
Inventories consist of the following (in thousands):
June 30,
2024
December 31,
2023
(Unaudited)
Raw materials$ $ 
Work-in-progress1,811  
Finished goods  
Inventories$1,811 $ 
Inventory is stated at the lower of cost or net realizable value and consists of raw materials, work-in-progress and finished goods. Cost is determined using a standard cost method, which approximates actual cost, and assumes a FIFO flow of goods. Inventory that is used for clinical development purposes is expensed in research and development expense, on the condensed consolidated statement of operations when consumed.
Cost of product revenue consists primarily of third-party manufacturing costs, distribution, and overhead costs related to sales of approved product subsequent to receiving regulatory approval. Cost of product revenue may also include costs related to excess or obsolete inventory adjustment charges, abnormal costs, unabsorbed manufacturing and overhead costs, and manufacturing variances. Based on our policy to expense costs associated with the manufacture of products prior to receiving regulatory approval, all costs associated with the production of ANKTIVA were expensed in research and development expense, on the condensed consolidated statement of operations in the period incurred and therefore are not reflected in cost of product revenue.
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The work-in-progress materials consists of bulk drug substance and drug product, which have a multi-year shelf life. When the bulk drug substance is manufactured into ANKTIVA drug product, those goods have a shelf life of two years from the date of manufacture. The work-in-progress drug product gets converted to finished goods at the time of labeling. Our expectation is to sell finished goods at least twelve months prior to expiration. Due to our long manufacturing lead time, it was necessary to build up inventory in support of ANKTIVA forecasted sales. As a result of being in the early stages of the ANKTIVA product launch, the company is continuing to evaluate the length of its operating cycle.
On a quarterly basis, the company analyzes its inventory levels for excess quantities and obsolescence (expiration), taking into account factors such as historical and anticipated future sales compared to quantities on hand and the remaining shelf-life. At June 30, 2024, we determined that a reserve related to ANKTIVA inventory for excess quantities and obsolescence is not required. In addition, since the FDA approval of ANKTIVA the company has not recorded any inventory write downs.
Property, Plant and Equipment, Net
Property, plant and equipment, net, consist of the following (in thousands):
June 30,
2024
December 31,
2023
(Unaudited)
Leasehold improvements$72,533 $72,552 
Equipment72,827 69,915 
Construction in progress85,322 84,436 
Furniture & fixtures1,878