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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2023
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: 001-36112
MACROGENICS, INC.
(Exact name of registrant as specified in its charter)
Delaware06-1591613
(State or other jurisdiction of
incorporation or organization)
(I.R.S. Employer
Identification No.)
9704 Medical Center Drive
Rockville, Maryland
20850
(Address of principal executive offices)(Zip code)
301-251-5172
(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, par value $0.01 per share
MGNXNasdaq 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  ☒   No  ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes  ☒   No  ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See definitions of "accelerated filer," "large accelerated filer," "smaller reporting company" and "emerging growth company" in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filerAccelerated filer
Non-accelerated filerSmaller reporting company
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.   ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes      No  ☒
As of November 3, 2023, 62,029,447 shares of the registrant's common stock, par value $0.01 per share, were outstanding.





TABLE OF CONTENTS

PART I.
Item 1.
Item 2.
Item 3.
Item 4.
PART II.
Item 1.
Item 1A.
Item 6.





FORWARD-LOOKING STATEMENTS
This report includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements include statements that may relate to our plans, objectives, goals, strategies, future events, future revenues or performance, capital expenditures, financing needs and other information that is not historical information. Many of these statements appear, in particular, under the headings "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in this Quarterly Report on Form 10-Q. Forward-looking statements can often be identified by the use of terminology such as "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy.
All forward-looking statements, including, without limitation, our examination of historical operating trends, are based upon our current expectations and various assumptions. We believe there is a reasonable basis for our expectations and beliefs, but they are inherently uncertain. We may not realize our expectations, and our beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements. The following uncertainties and factors, among others (including those set forth under "Item 1A. Risk Factors" of our Annual Report on Form 10-K for the year ended December 31, 2022 and "Part II, Item 1A. Risk Factors" of this Quarterly Report on Form 10-Q), could affect future performance and cause actual results to differ materially from those matters expressed in or implied by forward-looking statements:
our plans to develop and commercialize our product candidates;
the outcomes of our ongoing and planned clinical trials and the timing of those outcomes, including when clinical trials will be initiated or completed, enrollment of trials, and when data will be reported or regulatory filings will be made;
the timing of and our ability to obtain and maintain regulatory approvals for our product candidates and the labeling for any approved products;
our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
our ability to raise additional capital through the capital markets or through one or more corporate partnerships, equity offerings, debt financings, collaborations, licensing arrangements or asset sales;
our expectations regarding product candidates currently being developed by our collaborators;
our ability to enter into new collaborations or to identify additional products or product candidates with significant commercial potential that are consistent with our commercial objectives;
the potential benefits and future operation of our existing collaborations;
our ability to recover the investment in our manufacturing capabilities;
the rate and degree of market acceptance and clinical utility of our products;
our commercialization, marketing and manufacturing capabilities and strategy;
significant competition in our industry;
costs of litigation and the failure to successfully defend lawsuits and other claims against us and our expectations regarding the outcome of any regulatory or legal proceedings;
economic, political and other risks associated with our international operations;
our ability to receive research funding and achieve anticipated milestones under our collaborations;
our ability to protect and enforce patents and other intellectual property;
costs of compliance and our failure to comply with new and existing governmental regulations including, but not limited to, tax regulations;
loss or retirement of key members of management;
failure to successfully execute our growth strategy, including any delays in our planned future growth;
our failure to maintain effective internal controls; and
the severity and duration of the impact of a global pandemic on our business, operations, clinical programs, manufacturing, financial results and other aspects of our business.
Consequently, forward-looking statements speak only as of the date that they are made and should be regarded solely as our current plans, estimates and beliefs. You should not place undue reliance on forward-looking statements. We cannot guarantee future results, events, levels of activity, performance or achievements. Except as required by law, we do not undertake and specifically decline any obligation to update, republish or revise forward-looking statements to reflect future events or circumstances or to reflect the occurrences of unanticipated events.




PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS

MACROGENICS, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
September 30, 2023December 31, 2022
(unaudited)
Assets
Current assets:
Cash and cash equivalents$89,898 $108,884 
Marketable securities166,534 45,462 
Accounts receivable25,311 56,222 
Inventory, net 1,066 1,451 
Prepaid expenses and other current assets8,510 10,161 
Total current assets291,319 222,180 
Property, equipment and software, net22,634 29,575 
Operating lease right-of-use assets24,632 27,335 
Other non current assets1,387 1,378 
Total assets$339,972 $280,468 
Liabilities and stockholders' equity
Current liabilities:
Accounts payable$3,303 $4,899 
Accrued expenses and other current liabilities25,478 28,998 
Deferred revenue18,584 9,988 
Lease liabilities3,926 4,726 
Total current liabilities51,291 48,611 
Deferred revenue, net of current portion64,260 59,480 
Lease liabilities, net of current portion30,183 30,106 
Other non current liabilities258 258 
Total liabilities145,992 138,455 
Stockholders' equity:
Common stock, $0.01 par value -- 125,000,000 shares authorized, 62,028,904 and 61,701,467 shares outstanding at September 30, 2023 and December 31, 2022, respectively
620 617 
Additional paid-in capital1,250,074 1,235,095 
Accumulated other comprehensive income (loss)(34)(5)
Accumulated deficit(1,056,680)(1,093,694)
Total stockholders' equity193,980 142,013 
Total liabilities and stockholders' equity$339,972 $280,468 

See notes to consolidated financial statements.
1



MACROGENICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
(unaudited)
(in thousands, except share and per share data)


Three Months Ended September 30,Nine Months Ended September 30,
2023202220232022
Revenues:
Collaborative and other agreements$885 $35,674 $23,593 $59,630 
Product sales, net4,695 4,371 13,247 12,623 
Contract manufacturing 4,462 1,142 9,664 5,134 
Royalty revenue10  431  
Government agreements345 547 1,094 1,455 
Total revenues10,397 41,734 48,029 78,842 
Costs and expenses:
Cost of product sales85 3,007 456 3,235 
Cost of manufacturing services3,274 136 7,603 2,358 
Research and development30,131 48,191 119,232 161,372 
Selling, general and administrative12,409 15,355 39,628 45,277 
Total costs and expenses45,899 66,689 166,919 212,242 
Loss from operations(35,502)(24,955)(118,890)(133,401)
Gain on royalty monetization arrangement50,000  150,930  
Interest and other income3,056 142 6,404 841 
Interest expense  (1,430) 
Net income (loss)17,554 (24,813)37,014 (132,560)
Other comprehensive income (loss):
Unrealized gain (loss) on investments38 213 (30)(52)
Comprehensive income (loss)$17,592 $(24,600)$36,984 $(132,612)
Net income (loss) per common share:
Basic$0.28 $(0.40)$0.60 $(2.16)
Diluted $0.28 $(0.40)$0.60 $(2.16)
Weighted average common shares outstanding:
Basic61,980,680 61,459,831 61,890,824 61,390,143 
Diluted 62,244,602 61,459,831 62,090,343 61,390,143 

See notes to consolidated financial statements.

2



MACROGENICS, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
(unaudited)
(in thousands, except share amounts)


Common StockAdditional
Paid-In
Capital
Accumulated
Deficit
Accumulated
Other
Comprehensive Income (Loss)
Total
Stockholders'
Equity
SharesAmount
Balance, December 31, 202261,701,467 $617 $1,235,095 $(1,093,694)$(5)$142,013 
Share-based compensation— — 4,788 — — 4,788 
Issuance of common stock, net of offering costs95,000 1 616 — — 617 
Stock plan related activity42,098 — (154)— — (154)
Unrealized gain on investments— — — — 13 13 
Net loss— — — (38,009)— (38,009)
Balance, March 31, 202361,838,565 618 1,240,345 (1,131,703)8 109,268 
Share-based compensation— — 4,436 — — 4,436 
Issuance of common stock36,135 — 235 — — 235 
Stock plan related activity63,793 1 215 — — 216 
Unrealized loss on investments— — — — (80)(80)
Net income— — — 57,469 — 57,469 
Balance, June 30, 202361,938,493 619 1,245,231 (1,074,234)(72)171,544 
Share-based compensation— — 4,746 — — 4,746 
Issuance of common stock36,135 — 187 — — 187 
Stock plan related activity54,276 1 (90)— — (89)
Unrealized gain on investments— — — — 38 38 
Net income— — — 17,554 — 17,554 
Balance, September 30, 202362,028,904 $620 $1,250,074 $(1,056,680)$(34)$193,980 

See notes to consolidated financial statements.

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Common StockAdditional
Paid-In
Capital
Accumulated
Deficit
Accumulated
Other
Comprehensive Income (Loss)
Total
Stockholders'
Equity
SharesAmount
Balance, December 31, 202161,307,428 $613 $1,213,002 $(973,936)$(61)$239,618 
Share-based compensation— — 5,224 — — 5,224 
Stock plan related activity25,646 — 37 — — 37 
Unrealized loss on investments— — — — (222)(222)
Net loss— — — (66,443)— (66,443)
Balance, March 31, 202261,333,074 613 1,218,263 (1,040,379)(283)178,214 
Share-based compensation— — 5,350 — — 5,350 
Stock plan related activity125,716 2 262 — — 264 
Unrealized loss on investments— — — — (43)(43)
Net loss— — — (41,304)— (41,304)
Balance, June 30, 202261,458,790 615 1,223,875 (1,081,683)(326)142,481 
Share-based compensation— — 5,077 — — 5,077 
Stock plan related activity3,399 — — — — — 
Unrealized loss on investments— — — — 213 213 
Net loss— — — (24,813)— (24,813)
Balance, September 30, 202261,462,189 $615 $1,228,952 $(1,106,496)$(113)$122,958 


See notes to consolidated financial statements.
4



MACROGENICS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(in thousands)
Nine Months Ended September 30,
20232022
Cash flows from operating activities
Net income (loss)$37,014 $(132,560)
Adjustments to reconcile net income (loss) to net cash used in operating activities:
Depreciation and amortization expense7,745 8,634 
Amortization of premiums and discounts on marketable securities(3,276)740 
Stock-based compensation14,014 15,697 
Gain on royalty monetization arrangement(150,930) 
Non-cash interest expense1,430  
Non-cash lease expense2,703 2,468 
Other non-cash items423 2,882 
Loss on disposal of assets111  
Changes in operating assets and liabilities:
Accounts receivable30,911 (3,452)
Inventory385 419 
Prepaid expenses and other current assets1,651 11,898 
Other non current assets(7) 
Accounts payable(1,607)(10,897)
Accrued expenses and other current liabilities(3,388)(184)
Lease liabilities(723)(3,447)
Deferred revenue13,376 (8,477)
Net cash used in operating activities(50,168)(116,279)
Cash flows from investing activities
Purchases of marketable securities(217,216)(75,457)
Proceeds from sale and maturities of marketable securities99,390 155,190 
Purchases of property, equipment and software(1,144)(3,230)
Proceeds from sales of equipment64  
Net cash provided by (used in) investing activities(118,906)76,503 
Cash flows from financing activities
Proceeds from issuance of common stock, net of offering costs616  
Proceeds from stock option exercises and ESPP purchases279 314 
Taxes paid related to net share settlement of equity awards(306)(14)
Principal payments on royalty monetization arrangement(156) 
Net proceeds from sale of future royalties149,655  
Net cash provided by financing activities150,088 300 
Net change in cash and cash equivalents(18,986)(39,476)
Cash and cash equivalents at beginning of period108,884 123,469 
Cash and cash equivalents at end of period$89,898 $83,993 
Supplemental Cash Flow Information
Property, equipment and software included in accounts payable or accruals$166 $295 


See notes to consolidated financial statements.
5



MACROGENICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
1. Nature of Operations
Description of the business
MacroGenics, Inc. (the Company) is incorporated in the state of Delaware. The Company is a biopharmaceutical company focused on developing, manufacturing and commercializing innovative antibody-based therapeutics designed to modulate the human immune response for the treatment of cancer. The Company has a pipeline of product candidates being evaluated in clinical trials sponsored by MacroGenics or its collaborators. These product candidates include multiple oncology programs, some of which were created primarily using the Company’s proprietary, antibody-based technology platforms. The Company believes its product candidates have the potential, if approved for marketing by regulatory authorities, to have a meaningful effect on treating patients' unmet medical needs as monotherapy or, in some cases, in combination with other therapeutic agents. To date, three products originating from our pipeline of proprietary or partnered product candidates have received U.S. Food and Drug Administration (FDA) approval. In March 2021, the Company and its commercialization partner commenced U.S. marketing of MARGENZA (margetuximab-cmkb), a human epidermal growth factor receptor 2 (HER2) receptor antagonist indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. In November 2022, the FDA approved TZIELD® (teplizumab-mzwv) to delay the onset of Stage 3 Type 1 Diabetes (T1D) in adult and pediatric patients aged 8 years and older with Stage 2 T1D. Teplizumab was acquired from the Company by Provention Bio, Inc. (Provention) in May 2018, pursuant to an asset purchase agreement. In March 2023, the FDA approved ZYNYZ™ (retifanlimab-dlwr), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1). Retifanlimab was previously developed by the Company and licensed to Incyte Corporation (Incyte) pursuant to an exclusive global collaboration and license agreement in October 2017.
Liquidity
The Company’s multiple product candidates currently under development will require significant additional research and development efforts that include extensive preclinical studies and clinical testing, and regulatory approval prior to commercial use.
The future success of the Company is dependent on its ability to identify and develop its product candidates, and ultimately upon its ability to attain profitable operations. The Company has devoted substantially all of its financial resources and efforts to research and development and general and administrative expense to support such research and development. Net losses and negative cash flows have had, and will continue to have, an adverse effect on the Company’s stockholders’ equity and working capital, and accordingly, its ability to execute its future operating plans.
As a biotechnology company, the Company has primarily funded its operations with proceeds from the sale of its common stock in equity offerings and revenue from its multiple collaboration agreements. Management regularly reviews the Company’s available liquidity relative to its operating budget and forecast to monitor the sufficiency of the Company’s working capital. The Company plans to meet its future operating requirements by generating revenue from current and future strategic collaborations or other arrangements, product sales and royalties. The Company anticipates continuing to draw upon available sources of capital, including equity and debt instruments, to support its product development activities. If the Company is unable to enter into new arrangements or to perform under current or future agreements or obtain additional capital, the Company will assess its capital resources and may be required to delay, reduce the scope of, or eliminate one or more of its product research and development programs or clinical studies, reduce other operating expenses, and/or downsize its organization. Based on the Company’s most recent cash flow forecast, the Company believes its current resources are sufficient to fund its operating plans for a minimum of twelve months from the date that this Quarterly Report on Form 10-Q was filed.
Similar to the other risk factors pertinent to the Company's business, geopolitical tensions and related global slowdown of economic activity, decades-high inflation, rising interest rates, adverse events involving financial institutions or the financial services industry and a potential recession in the United States might unfavorably impact the Company's ability to generate such additional funding. Given the uncertainty in the rapidly changing market and economic conditions related to these uncertainties, the Company will continue to evaluate the nature and extent of the impact of these uncertainties on its business and financial position.
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Basis of Presentation
The accompanying unaudited interim consolidated financial statements of the Company have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) for interim financial information. The financial statements include all adjustments (consisting only of normal recurring adjustments) that the management of the Company believes are necessary for a fair presentation of the periods presented. These interim financial results are not necessarily indicative of results expected for the full fiscal year or for any subsequent interim period.
The accompanying unaudited interim consolidated financial statements include the accounts of MacroGenics, Inc. and its wholly owned subsidiaries, MacroGenics UK Limited and MacroGenics Limited. All intercompany accounts and transactions have been eliminated in consolidation. These consolidated financial statements and related notes should be read in conjunction with the financial statements and notes thereto included in the Company's 2022 Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 15, 2023.
2. Summary of Significant Accounting Policies
During the nine months ended September 30, 2023, the Company adopted the following significant accounting policies in addition to those disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022.
Liability related to the sale of future royalties and related interest expense
The Company assesses the relevant accounting criteria under Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) 470, Debt (ASC 470) to determine whether the upfront payment received from the purchaser should be accounted for as debt or deferred income depending on the facts and circumstances. If the criteria in ASC 470 is met, the Company accounts for net proceeds from sales of its rights to receive future royalty payments as a liability that is amortized using the effective interest method over the term of the arrangement. The liability related to future royalties is presented net of unamortized issuance costs on the consolidated balance sheets. Interest expense on the liability related to future royalties is recognized using the effective interest rate method over the life of the arrangement. The Company calculates an effective interest rate which will amortize its related obligation to zero over the anticipated repayment period. The liability related to future royalties and the related interest expense are based on the Company’s current estimates of future royalties expected to be received over the life of the arrangement, which the Company determines by using internal sales projections and external information from market data sources, which are considered Level 3 inputs. The Company periodically assesses the expected payments and to the extent the Company’s estimates of future royalty payments are greater or less than previous estimates or the estimated timing of such payments is materially different than previous estimates, the Company will adjust the effective interest rate and recognize related non-cash interest expense on a prospective basis. Non-cash amortization is reflected as interest expense in the consolidated statements of operations and comprehensive income (loss).
Upon changes in facts and circumstances, for example as a result of a modification to the existing agreements, the Company re-evaluates its rights and obligations and accounts for the change in accordance with the respective accounting guidance.
Recent Accounting Pronouncements
There were no new accounting pronouncements that were issued or became effective since the issuance of the Company’s 2022 Annual Report on Form 10-K that had, or are expected to have, a material impact on its consolidated financial position, results of operations or cash flows.
3. Fair Value of Financial Instruments
The Company's financial instruments consist of cash and cash equivalents, marketable securities, accounts receivable, accounts payable and accrued expenses. The carrying amount of accounts receivable, accounts payable and accrued expenses are generally considered to be representative of their respective fair values because of their short-term nature.  The Company accounts for recurring and non-recurring fair value measurements in accordance with ASC 820, Fair Value Measurements and Disclosures (ASC 820). ASC 820 defines fair value, establishes a fair value hierarchy for assets and liabilities measured at fair value, and requires expanded disclosures about fair value measurements. The ASC 820 hierarchy ranks the quality of reliability of inputs, or assumptions, used in the determination of fair value and requires assets and liabilities carried at fair value to be classified and disclosed in one of the following three categories:
Level 1 - Fair value is determined by using unadjusted quoted prices that are available in active markets for identical assets and liabilities.
7



Level 2 - Fair value is determined by using inputs other than Level 1 quoted prices that are directly or indirectly observable. Inputs can include quoted prices for similar assets and liabilities in active markets or quoted prices for identical assets and liabilities in inactive markets. Related inputs can also include those used in valuation or other pricing models, such as interest rates and yield curves that can be corroborated by observable market data.
Level 3 - Fair value is determined by inputs that are unobservable and not corroborated by market data. Use of these inputs involves significant and subjective judgments to be made by a reporting entity - e.g., determining an appropriate adjustment to a discount factor for illiquidity associated with a given security.
The Company evaluates financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level at which to classify them each reporting period. This determination requires the Company to make subjective judgments as to the significance of inputs used in determining fair value and where such inputs lie within the ASC 820 hierarchy. There were no transfers between levels during the periods presented.
Financial assets measured at fair value on a recurring basis were as follows (in thousands):
Fair Value Measurements at September 30, 2023
TotalLevel 1Level 2
Assets:
Money market funds$51,137 $51,137 $ 
U.S. Treasury securities26,038 26,038  
Government-sponsored enterprises83,695  83,695 
Corporate debt securities56,801  56,801 
Total assets measured at fair value(a)
$217,671 $77,175 $140,496 
Fair Value Measurements at December 31, 2022
TotalLevel 1Level 2
Assets:
Money market funds$41,564 $41,564 $ 
Government-sponsored enterprises32,811  32,811 
Corporate debt securities17,626  17,626 
Total assets measured at fair value(b)
$92,001 $41,564 $50,437 
(a) Total assets measured at fair value at September 30, 2023 includes approximately $51.1 million reported in cash and cash equivalents on the consolidated balance sheet.
(b) Total assets measured at fair value at December 31, 2022 includes approximately $46.5 million reported in cash and cash equivalents on the consolidated balance sheet.
8



4. Marketable Securities
The following tables summarize the Company's marketable debt securities (in thousands):
September 30, 2023
Amortized
Cost
Gross
Unrealized
Gains
Gross
Unrealized
Losses
Fair
Value
U.S. Treasury securities$26,050 $ $(12)$26,038 
Government-sponsored enterprises83,671 40 (16)83,695 
Corporate debt securities56,847  (46)56,801 
Total$166,568 $40 $(74)$166,534 
December 31, 2022
Amortized
Cost
Gross
Unrealized
Gains
Gross
Unrealized
Losses
Fair
Value
Government-sponsored enterprises$32,812 $5 $(7)$32,810 
Corporate debt securities12,655 1 (4)12,652 
Total$45,467 $6 $(11)$45,462 

All available-for-sale marketable debt securities held as of September 30, 2023 and December 31, 2022 had contractual maturities of less than one year. All of the Company's available-for-sale marketable debt securities in an unrealized loss position as of September 30, 2023 and December 31, 2022 were in a loss position for less than twelve months. Unrealized losses on available-for-sale debt securities as of September 30, 2023 and December 31, 2022 were not significant and were primarily due to changes in interest rates, including market credit spreads, and not due to increased credit risks associated with specific securities. Accordingly, no allowance for credit losses related to the Company's available-for-sale debt securities was recorded for any periods presented. The Company does not intend to sell these investments and it is not more likely than not that the Company will be required to sell the investments before recovery of their amortized cost bases, which may be at maturity.
5. Inventory, Net
All of the Company's inventory relates to the manufacturing of MARGENZA. The following table sets forth the Company's net inventory (in thousands):
September 30, 2023December 31, 2022
Work in process$ $409 
Finished goods1,066 1,042 
Total inventory, net$1,066 $1,451 

Prior to FDA approval of MARGENZA in December 2020, the cost of materials and expenses associated with the manufacturing of MARGENZA were recorded as research and development expense. Subsequent to FDA approval, the Company began capitalizing inventory costs related to the manufacture of MARGENZA. The inventory balance as of September 30, 2023 and December 31, 2022 is net of a reserve of $4.9 million for unsaleable inventory. These reserves are reflected in cost of product sales during the period they are recorded.
6. Royalty Monetization Arrangement
In March 2023, the Company entered into a Purchase and Sale Agreement (Royalty Purchase Agreement) with DRI Healthcare Acquisitions LP (DRI), a wholly owned subsidiary of DRI Healthcare Trust, for the sale to DRI of the Company’s single-digit royalty interest on global net sales of TZIELD (teplizumab-mzwv) under the Company’s Asset Purchase Agreement dated May 7, 2018, as amended (the Provention APA), with Provention. The Company retained its other economic interests related to TZIELD under the Provention APA, including future potential development, regulatory, and commercial milestones.
9



Under the terms of the Royalty Purchase Agreement, the Company received $100.0 million from DRI for its single-digit royalty interest on global net sales of TZIELD under the Provention APA (the Royalty Interest). Additionally, the Company has the right to receive a 50% share of the royalty on global net sales above a certain annual threshold (the Retained Interest). In addition, the Company was eligible to receive up to $50.0 million upon the occurrence of pre-specified events tied to the advancement of TZIELD for the treatment of newly diagnosed type 1 diabetes. This milestone was achieved in July 2023 as described below. The Company is also eligible to receive an additional $50.0 million milestone if TZIELD achieves a certain level of net sales (Sales Milestone Payment).
The $100.0 million proceeds received from DRI for the Royalty Interest were recorded as a liability related to future royalties, net of transaction costs of $0.3 million, which was to be amortized over the term of the arrangement using the effective interest rate method. At inception, the Company accounted for the Royalty Purchase Agreement as a financing arrangement because the Company had significant continuing involvement in the delivery of future royalty payments to DRI and other existing obligations under the Provention APA.
In April 2023, the Company entered into an agreement (the Tripartite Agreement) with DRI and a subsidiary of Sanofi S.A. (Sanofi), whereby the Company consented to the sale of DRI’s Royalty Interest and related milestone payment obligations to Sanofi. The Tripartite Agreement eliminated the Company’s obligation to deliver payments to DRI related to the Royalty Interest and removed all of the Company’s other obligations under the Royalty Purchase Agreement. The Royalty Interest will be paid directly to Sanofi by Provention. As a result, the Company’s royalty rights are only for the Retained Interest. This change in rights and obligations resulted in a change in the terms of the liability related to future royalties which was evaluated by the Company in accordance with ASC 470-50, Debt — Modifications and Extinguishments. The Company concluded that the execution of the Tripartite Agreement resulted in a modification to the liability related to future royalties. The Company determined that the terms of the new liability related to the single-digit future royalties and the original liability related to future royalties were substantially different as the Company no longer receives payments for the Royalty Interest and therefore has a significantly reduced liability to make payments in accordance with the Royalty Purchase Agreement. The new liability related to future royalties was determined to be de minimis. As a result, the Company recorded $100.9 million within other income on the statement of operations and comprehensive income (loss) during the three months ended June 30, 2023. There was no modification to the Company's Retained Interest in the Tripartite Agreement.
In July 2023, Sanofi reported achievement of the primary endpoint milestone event related to the $50.0 million milestone noted above. Given that the Company has no continuing obligation to pay the Royalty Interest to Sanofi, the Company recorded this milestone within other income on the statement of operations and comprehensive income (loss) during the three months ended September 30, 2023. Also in September 2023, the Company and Sanofi executed Amendment No. 2 to the Provention APA to incorporate the Sales Milestone Payment obligation from the Royalty Purchase Agreement into the Provention APA. In addition, the Company and Sanofi terminated the Royalty Purchase Agreement, which did not result in a material impact to the financial statements given the fair value of the liability related to future royalties was de minimis.
Changes to the liability related to future royalties were as follows for the nine months ended September 30, 2023 (in thousands):

Liability related to future royalties - beginning balance$ 
Proceeds from sale of future royalties150,000 
Deferred transaction costs(344)
Royalty revenue payable to DRI(156)
Interest expense recognized1,430 
Gain on royalty monetization arrangement(150,930)
Liability related to future royalties - ending balance$ 

7. Stockholders' Equity
In November 2020, the Company entered into a sales agreement (Sales Agreement) with an agent to sell, from time to time, shares of its common stock having an aggregate sales price of up to $100.0 million through an “at the market offering” (ATM Offering) as defined in Rule 415 under the Securities Act of 1933, as amended. The Company sold 3,622,186 shares of common stock resulting in net proceeds of approximately $98.2 million through December 31, 2021 under the Sales Agreement. In April 2021, the Company entered into Amendment No. 1 to the Sales Agreement which increased the amount of
10



the Company’s common stock that can be sold by the Company through its agent under the ATM Offering, from an aggregate offering price of up to $100.0 million to an aggregate offering price of up to $300.0 million. In March 2023, the Company terminated the Sales Agreement and entered into a new sales agreement with an agent to sell, from time to time, shares of its common stock having an aggregate sales price of up to $100.0 million through an ATM Offering. During the nine months ended September 30, 2023, the Company sold 95,000 shares of common stock at a weighted average price per share of $6.60, resulting in net proceeds of approximately $0.6 million, net of offering expenses.

8. Revenue
Collaborative and Other Agreements
Incyte Corporation
Incyte License Agreement
In 2017, the Company entered into an exclusive global collaboration and license agreement with Incyte , which was amended in March 2018, April 2022 and July 2022, for retifanlimab, an investigational monoclonal antibody that inhibits PD-1 (Incyte License Agreement). Incyte has obtained exclusive worldwide rights for the development and commercialization of retifanlimab in all indications, while the Company retains the right to develop its pipeline assets in combination with retifanlimab. Under the terms of the Incyte License Agreement, Incyte paid the Company an upfront payment of $150.0 million in 2017. MacroGenics will manufacture a portion of Incyte’s global commercial supply of retifanlimab. In March 2023, the FDA approved Incyte's Biologics License Application (BLA) for ZYNYZ (retifanlimab-dlwr) for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma. Incyte has stated it is pursuing development of retifanlimab in potentially registration-enabling studies, including in patients with squamous cell carcinoma of the anal canal, MSI-high endometrial cancer and non-small cell lung cancer. Incyte is also pursuing development of retifanlimab in combination with multiple product candidates from its pipeline.
Under the terms of the Incyte License Agreement, as amended, Incyte will lead global development of retifanlimab. Assuming successful development and commercialization by Incyte in multiple indications, the Company could receive up to a total of $435.0 million in development and regulatory milestones and up to $330.0 million in commercial milestones. From the inception of the Incyte License Agreement through September 30, 2023, the Company has recognized $115.0 million in development milestones under the Incyte License Agreement, including $15.0 million received following the FDA approval of ZYNYZ. The Company is also eligible to receive tiered royalties of 15% to 24% on global net sales. The Company retains the right to develop its pipeline assets in combination with retifanlimab, with Incyte commercializing retifanlimab and the Company commercializing its asset(s), if any such potential combinations are approved. In addition, the Company retains the right to manufacture a portion of both companies' global commercial supply needs of retifanlimab, subject to the separate commercial supply agreement.
The Company evaluated the Incyte License Agreement under the provisions of Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (ASC 606) at inception and identified the following two performance obligations under the agreement: (i) the license of retifanlimab and (ii) the performance of certain clinical activities through a brief technology transfer period. The Company determined that the license and clinical activities are separate performance obligations because they are capable of being distinct and are distinct in the context of the contract. The license has standalone functionality as it is sublicensable, Incyte has significant capabilities in performing clinical trials, and Incyte is capable of performing these activities without the Company's involvement; the Company performed the activities during the transfer period as a matter of convenience. The Company determined that the transaction price of the Incyte License Agreement at inception was $154.0 million, consisting of the consideration to which the Company was entitled in exchange for the license and an estimate of the consideration for clinical activities to be performed. The transaction price was allocated to each performance obligation based on their relative standalone selling price. The standalone selling price of the license was determined using the adjusted market assessment approach considering similar collaboration and license agreements. The standalone selling price for the agreed-upon clinical activities to be performed was determined using the expected cost approach based on similar arrangements the Company has with other parties. The potential development and regulatory milestone payments are fully constrained until the Company concludes that achievement of the milestone is probable, and that recognition of revenue related to the milestone will not result in a significant reversal in amounts recognized in future periods, and as such have been excluded from the transaction price. Any consideration related to sales-based milestones and royalties will be recognized when the related sales occur, as they were determined to relate predominantly to the license granted to Incyte and, therefore, have also been excluded from the transaction price. The Company re-assesses the transaction price in each reporting period and when events whose outcomes are resolved or other changes in circumstances occur. From 2018 through September 30, 2023, it became probable that a significant reversal of cumulative revenue would not occur for development
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milestones totaling $115.0 million related to clinical and regulatory activities related to the further advancement of retifanlimab. Therefore, the associated consideration was added to the estimated transaction price and was recognized as revenue.

The Company recognized the $150.0 million allocated to the license when it satisfied its performance obligation and transferred the license to Incyte in 2017. The $4.0 million allocated to the clinical activities was recognized ratably as services were performed during 2017 and 2018. The Company recognized the $15.0 million ZYNYZ approval milestone as revenue under the Incyte License Agreement during the nine months ended September 30, 2023. $30.0 million in revenue was recognized under the Incyte License Agreement during the three and nine months ended September 30, 2022.
Incyte Clinical Supply Agreement
In 2018, the Company entered into an agreement with Incyte, under which the Company is to perform development and manufacturing services for Incyte’s clinical needs of retifanlimab (Incyte Clinical Supply Agreement). The Company evaluated the Incyte Clinical Supply Agreement under ASC 606 and identified one performance obligation under the agreement: to perform services related to the development and manufacturing of the clinical supply of retifanlimab. The transaction price is based on the costs incurred to develop and manufacture drug product and drug substance, and is recognized over time as the services are provided, as the performance by the Company does not create an asset with an alternative use and the Company has an enforceable right to payment for the performance completed to date. The transaction price is being recognized using the input method reflecting the costs incurred (including resources consumed and labor hours expended) related to the manufacturing services. During the three months ended September 30, 2023 and 2022, the Company recognized revenue of $0.2 million and $0.1 million, respectively, for services performed under the Incyte Clinical Supply Agreement. During the nine months ended September 30, 2023 and 2022, the Company recognized revenue of $1.7 million and $0.6 million, respectively, for services performed under the Incyte Clinical Supply Agreement.
Gilead Sciences, Inc
In October 2022, the Company and Gilead Sciences, Inc. (Gilead) entered into an exclusive option and collaboration agreement (Gilead Agreement) to develop and commercialize MGD024, an investigational, bispecific antibody that binds CD123 and CD3, and create bispecific cancer antibodies using the Company’s DART platform and undertake their early development under a maximum of two separate bispecific cancer target research programs. Under the agreement, the Company will continue the ongoing phase 1 trial for MGD024 according to a development plan, during which Gilead will have the right to exercise an option granted to Gilead to obtain an exclusive license under the Company’s intellectual property to develop and commercialize MGD024 and other bispecific antibodies of MacroGenics that bind CD123 and CD3 (CD123 Option). The agreement also grants Gilead the right, within its first two years, to nominate a bispecific cancer target set for up to two research programs conducted by the Company and to exercise separate options to obtain an exclusive license for the development, commercialization and exploitation of molecules created under each research program (Research Program Option). Gilead nominated the first of the two research programs in September 2023.
Under the terms of the Gilead Agreement, in October 2022 Gilead paid the Company an upfront payment of $60.0 million. Assuming Gilead exercises the CD123 Option and Research Program Option and successfully develops and commercializes MGD024, or other CD123 products developed under the agreement, and products result from the two additional research programs, the Company would be eligible to receive up to $1.7 billion in target nomination, option fees, and development, regulatory and commercial milestones. Assuming exercise of the CD123 Option, the Company will also be eligible to receive tiered, low double-digit royalties on worldwide net sales of MGD024 (or other CD123 products developed under the agreement) and assuming exercise of the Research Program Option, a flat royalty on worldwide net sales of any products resulting from the two research programs.
The Company evaluated the Gilead Agreement under the provisions of ASC 606 and identified the following material promises under the agreement: (i) a license to perform any activities allocated to Gilead under the MGD024 development plan; (ii) development activities regarding MGD024, including manufacturing, research and early clinical development activities, necessary to deliver an informational package of development and clinical data, information and materials specified in the Gilead Agreement during the period in which Gilead can exercise the CD123 Option; (iii) the CD123 Option and (iv) the Research Program Option.
The Company concluded that the license under the MGD024 development plan and development activities are not distinct from one another, as the license has limited value without the Company’s performance of the development activities. Therefore, the Company determined that the development term license and development activities should be combined into a single performance obligation (Development Activities). The CD123 Option is considered a material right as the value of the exclusive license exceeds the payment to be made by Gilead if they exercise their option to obtain an exclusive license to develop and commercialize MGD024 or an alternative CD123 product, and is therefore a distinct performance obligation. The
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Company determined that the Research Program Option does not provide a material right, as there is no discount on its standalone selling price.
In accordance with ASC 606, the Company determined that the initial transaction price under the Gilead Agreement was $60.0 million, consisting of the upfront, non-refundable payment paid by Gilead. The CD123 Option and Research Program Option payments are excluded from the initial transaction price at contract inception along with any future development, regulatory, and commercial milestone payments (including royalties) following the CD123 Option and Research Program Option exercise. The Company reassesses the amount of variable consideration included in the transaction price every reporting period. The Company allocated the $60.0 million upfront payment in the transaction price to the Development Activities and the CD123 Option based on each performance obligation’s relative standalone selling price. The standalone selling price for the Development Activities was calculated using an expected cost-plus margin approach for the pre-option development timeline. For the standalone selling price of the CD123 Option, the Company utilized an income-based approach which included the following key assumptions: post-option development timeline and costs, forecasted revenues, discount rates and probabilities of technical and regulatory success.
The Company is recognizing revenue related to the Development Activities performance obligation over the estimated period to complete the Development Activities using an input method reflecting the costs incurred (including resources consumed and labor hours expended) related to the Development Activities. The Company will defer revenue recognition related to the CD123 Option. If Gilead exercises the CD123 Option and obtains an exclusive license, the Company will recognize revenue as it fulfills its obligations under the Gilead Agreement. If the CD123 Option is not exercised, the Company will recognize the entirety of the revenue in the period when the CD123 Option expires.
During the three and nine months ended September 30, 2023, the Company recorded revenue of $0.4 million and $1.0 million, respectively, related to the Gilead Agreement. As of September 30, 2023, $58.9 million in revenue was deferred under this agreement, $2.2 million of which was current and $56.7 million of which was non-current. As of December 31, 2022, $59.8 million in revenue was deferred under this agreement, $1.8 million of which was current and $58.0 million of which was non-current.
During the three months ended September 30, 2023, the Company and Gilead executed a Letter Agreement through which Gilead nominated the first of the two research programs contemplated in the Gilead Agreement (First Research Program), the Company granted Gilead a research license, and the parties agreed on a research plan for the First Research Program under which the Company will provide research and development services. Gilead paid the Company a $15.7 million nomination fee, which was received by the Company in October 2023. The Company evaluated the Letter Agreement under the terms of ASC 606, and concluded that it is a modification to the Gilead Agreement that results in a separate contract since the modification is for additional goods and services that are distinct and at standalone selling price. The Company determined that the license and the related research and development activities were not distinct from one another, as the license has limited value without the performance of the research and development activities. As such, the Company determined that these should be combined into a single performance obligation. Gilead also has the exclusive option to pay the Company $10.0 million to obtain a license to exploit the research molecule and research product with respect to the First Research Program. The Company determined that this exclusive option does not provide a material right, as there is no discount on its standalone selling price.
In accordance with ASC 606, the Company determined that the initial transaction price for the First Research Program agreement was $15.7 million, consisting of the non-refundable payment paid by Gilead. The Company is recognizing revenue over the estimated period to complete the services using the input method reflecting the costs incurred (including resources consumed and labor hours expended) related to the research and development services.
During the three and nine months ended September 30, 2023, the Company recorded revenue of $0.1 million related to the First Research Program. As of September 30, 2023, $15.6 million in revenue was deferred under this agreement, $10.0 million of which was current and $5.6 million of which was non-current.
Zai Lab Limited
2018 Zai Lab Agreement
In 2018, the Company entered into a collaboration and license agreement with Zai Lab Limited (Zai Lab) under which Zai Lab obtained regional development and commercialization rights in mainland China, Hong Kong, Macau and Taiwan (Zai Lab’s territory) for (i) margetuximab, an immune-optimized anti-HER2 monoclonal antibody, (ii) tebotelimab, a bispecific DART® molecule designed to provide coordinate blockade of PD-1 and LAG-3 for the potential treatment of a range of solid tumors and hematological malignancies, and (iii) an undisclosed multi-specific TRIDENT molecule in preclinical development (2018 Zai Lab Agreement). Zai Lab will lead clinical development of these molecules in its territory. Zai Lab has informed the
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Company that they have decided to discontinue development of tebotelimab for indications they were enrolling in their territory and is evaluating future development plans in other indications.
Under the terms of the 2018 Zai Lab Agreement, Zai Lab paid the Company an upfront payment of $25.0 million ($22.5 million after netting value-added tax withholdings of $2.5 million). Assuming successful development and commercialization of margetuximab, tebotelimab and the TRIDENT molecule, the Company could receive up to $140.0 million in development and regulatory milestones, of which the Company has earned and received $9.0 million through September 30, 2023. In addition, Zai Lab would pay the Company tiered royalties at percentage rates of mid-teens to 20% for net sales of margetuximab in Zai Lab’s territory, mid-teens for net sales of tebotelimab in Zai Lab’s territory and 10% for net sales of the TRIDENT molecule in Zai Lab’s territory, which may be subject to adjustment in specified circumstances.
The Company evaluated the 2018 Zai Lab Agreement under the provisions of ASC 606 and identified the following material promises under the arrangement for each of the two product candidates, margetuximab and tebotelimab: (i) an exclusive license to develop and commercialize the product candidate in Zai Lab’s territory and (ii) certain research and development activities. The Company determined that each license and the related research and development activities were not distinct from one another, as the license has limited value without the performance of the research and development activities. As such, the Company determined that these promises should be combined into a single performance obligation for each product candidate. Activities related to margetuximab and tebotelimab are separate performance obligations from each other because they are capable of being distinct, and are distinct in the context of the contract. The Company evaluated the promises related to the TRIDENT molecule and determined they were immaterial in context of the contract, therefore there is no performance obligation related to that molecule. The Company determined that the net $22.5 million upfront payment from Zai Lab constituted the entirety of the consideration to be included in the transaction price as of the outset of the arrangement, and the transaction price was allocated to the two performance obligations based on their relative standalone selling price. The standalone selling price of the performance obligations was determined using the adjusted market assessment approach considering similar collaboration and license agreements. The potential development and regulatory milestone payments are fully constrained until the Company concludes that achievement of the milestone is probable, and that recognition of revenue related to the milestone will not result in a significant reversal in amounts recognized in future periods, and as such have been excluded from the transaction price. Any consideration related to royalties will be recognized if and when the related sales occur, as they were determined to relate predominantly to the license granted to Zai Lab and, therefore, have also been excluded from the transaction price.
The Company re-assesses the transaction price in each reporting period and when events whose outcomes are resolved or other changes in circumstances occur. From 2020 through September 30, 2023, it became probable that a significant reversal of cumulative revenue would not occur for development and regulatory milestones totaling $9.0 million. Therefore, the associated consideration, $8.1 million net of value-added tax withholdings, was added to the estimated transaction price and was recognized as revenue. No revenue was recognized under the 2018 Zai Lab Agreement during the three and nine months ended September 30, 2023. During the three months ended September 30, 2022, no revenue was recognized, and during the nine months ended September 30, 2022, the Company recognized revenue of $4.9 million under the 2018 Zai Lab Agreement.
2021 Zai Lab Agreement

In June 2021, the Company entered into a collaboration and license agreement with Zai Lab US LLC (collectively with Zai Lab Limited referred herein as Zai Lab) involving collaboration programs and license-only programs (collectively, the Programs) encompassing four separate immuno-oncology molecules (2021 Zai Lab Agreement). In August 2022, the Company and Zai Lab agreed to discontinue research and development of the Lead Program. In August 2023, the parties mutually agreed to terminate the 2021 Zai Lab Agreement.
In connection with the execution of the 2021 Zai Lab Agreement, Zai Lab paid the Company an upfront payment of $25.0 million. Additionally, as part of the consideration for the rights granted to Zai Lab under the 2021 Zai Lab Agreement, the Company and Zai Lab entered into a stock purchase agreement whereby Zai Lab paid the Company approximately $30.0 million to purchase shares of the Company’s common stock, par value $0.01, at a fixed price of $31.30 which represented a $10.4 million premium over the share price on the stock purchase agreement date.
The Company evaluated the 2021 Zai Lab Agreement under the provisions of ASC 606 and identified four performance obligations included in the 2021 Zai Lab Agreement.The Company concluded that the estimated transaction price was $40.4 million, consisting of the $25.0 million upfront payment, the $10.4 million premium related to the purchase of the Company’s common stock, and the $5.0 million estimated reimbursement by Zai Lab for research and development activities for the Lead Program. The transaction price of $40.4 million was then allocated to the four performance obligations based on their relative standalone selling price. The standalone selling price of the performance obligations was not directly observable; therefore, the Company estimated the standalone selling price using an adjusted market assessment approach, representing the
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amount that the Company believed a market participant was willing to pay for the product or service. The estimate was based on consideration of observable inputs, such as values of other preclinical collaboration arrangements adjusted for the Company’s estimate of the probability of success for each Program.
Revenue related to the Lead Program license and related research and development services performance obligation was recognized over time as the research and development activities were performed. The Company utilized a cost-based input method according to costs incurred to date compared to estimated total costs. The transfer of control occured over this time period and, in management’s judgment, was the best measure of progress towards satisfying the performance obligations. The Company recognized revenue allocated to the other programs at a point in time upon transfer of the licenses to Zai Lab in 2021. During the three and nine months ended September 30, 2023, no revenue was recognized under the 2021 Zai Lab Agreement. During the three and nine months ended September 30, 2022, the Company recognized revenue of $1.8 million and $16.8 million, respectively, under the 2021 Zai Lab Agreement.
Provention Bio, Inc.
In 2018, the Company entered into a license agreement with Provention pursuant to which the Company granted Provention exclusive global rights for the purpose of developing and commercializing MGD010 (renamed PRV-3279), a CD32B x CD79B DART molecule being developed for the treatment of autoimmune indications (Provention License Agreement). As partial consideration for the Provention License Agreement, Provention granted the Company a warrant to purchase shares of Provention’s common stock at an exercise price of $2.50 per share. If Provention successfully develops, obtains regulatory approval for, and commercializes PRV-3279, the Company will be eligible to receive up to $65.0 million in development and regulatory milestones and up to $225.0 million in commercial milestones. As of September 30, 2023, the Company has not recognized any milestone revenue under this agreement. If commercialized, the Company would be eligible to receive single-digit royalties on net sales of the product. The license agreement may be terminated by either party upon a material breach or bankruptcy of the other party, by Provention without cause upon prior notice to the Company, and by the Company in the event that Provention challenges the validity of any licensed patent under the agreement, but only with respect to the challenged patent.
Also, in 2018, the Company entered into the Provention APA pursuant to which Provention acquired the Company’s interest in teplizumab (renamed PRV-031), a monoclonal antibody being developed for the treatment of type 1 diabetes. As partial consideration for the Provention APA, Provention granted the Company a warrant to purchase shares of Provention’s common stock at an exercise price of $2.50 per share. Under the Provention APA, Provention is obligated to pay the Company contingent milestone payments totaling $170.0 million upon the achievement of certain regulatory milestones. In addition, Provention is obligated to make contingent milestone payments to the Company totaling $225.0 million upon the achievement of certain commercial milestones as well as single-digit royalties on net sales of the product. In March 2023, the Company entered into a Royalty Purchase Agreement with DRI; see Note 6, Royalty Monetization Arrangement, for additional information. The FDA approved the BLA for TZIELD in November 2022, and the Company recognized $60.0 million in revenue related to this regulatory milestone during the year ended December 31, 2022. In November 2022, the Company and Provention amended the Provention APA. Under this amendment, the milestone for first approval was split into four equal payments, all of which were received prior to June 30, 2023. Provention has also agreed to pay third-party obligations, including low single-digit royalties of which a portion is creditable against royalties payable to the Company, aggregate milestone payments of up to approximately $1.3 million and other consideration, for certain third-party intellectual property under agreements Provention assumed pursuant to the Provention APA. Further, Provention is required to pay the Company a low double-digit percentage of certain consideration to the extent it is received in connection with a future grant of rights to PRV-031 by Provention to a third party.
The Company evaluated the Provention License Agreement and Provention APA under the provisions of ASC 606 and determined that they should be accounted for as a single contract and identified two performance obligations within that contract: (i) the license of MGD010 and (ii) the title to teplizumab. The Company determined that the transaction price of the Provention agreements was $6.1 million, based on the Black-Scholes valuation of the warrants to purchase a total of 2,432,688 shares of Provention's common stock. The transaction price was allocated to each performance obligation based on the number of shares of common stock the Company is entitled to purchase under each warrant. The potential development and regulatory milestone payments are fully constrained until the Company concludes that achievement of the milestone is probable and that recognition of revenue related to the milestone will not result in a significant reversal in amounts recognized in future periods, and as such were excluded from the initial transaction price. Any consideration related to sales-based milestones and royalties will be recognized when the related sales occur, therefore they have also been excluded from the transaction price. The Company re-assesses the transaction price in each reporting period and when events whose outcomes are resolved or other changes in circumstances occur. The Company recognized revenue of $6.1 million when it satisfied its performance obligations under the agreements and transferred the MGD010 license and teplizumab assets to Provention in 2018. In 2019, the Company
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exercised the warrants on a cashless basis, and subsequently sold all the shares of Provention common stock acquired through the exercise. No shares of Provention stock were held subsequent to the sale of stock in 2019. During the year ended December 31, 2022, it became probable that a significant reversal of cumulative revenue would not occur for a regulatory milestone of $60.0 million, therefore the associated consideration was added to the estimated transaction price and was recognized as revenue.
On April 27, 2023, Sanofi completed its acquisition of Provention. Concurrently on April 27, 2023, the Company entered into a Tripartite Agreement, as discussed in Note 6, Royalty Monetization Arrangement. Also on April 27, 2023, the Company and a subsidiary of Sanofi entered into a Side Letter Agreement which specified certain post-closing covenants and also accelerated certain payments due to the Company under the Provention APA upon the closing of the merger between Sanofi and Provention. The Company evaluated the Side Letter Agreement as a contract modification under the provisions of ASC 606. As a result, during the nine months ended September 30, 2023, the Company recognized $5.5 million related to other consideration under the Provention APA and Side Letter Agreement. During the nine months ended September 30, 2023, the Company recognized $0.3 million in royalty revenue under the Provention APA based on sales of TZIELD.

As discussed in Note 6, in September 2023, the Company and Sanofi executed Amendment No. 2 to the Provention APA and terminated the Royalty Purchase Agreement with DRI. As a result, the remaining $50.0 million milestone under the Royalty Purchase Agreement was incorporated into the Provention APA. The Company evaluated the amendment as a contract modification under the provisions of ASC 606 which did not result in any revenue being recognized during the three or nine months ended September 30, 2023.
I-Mab Biopharma
I-Mab License Agreement

In 2019, the Company entered into a collaboration and license agreement with I-Mab Biopharma (I-Mab) to develop and commercialize enoblituzumab, an immune-optimized, anti-B7-H3 monoclonal antibody that incorporates the Company's proprietary Fc Optimization technology platform (I-Mab License Agreement). I-Mab obtained regional development and commercialization rights in mainland China, Hong Kong, Macau and Taiwan (I-Mab's territory), lead clinical development of enoblituzumab in its territories, and will participate in global studies conducted by the Company. The I-Mab License Agreement was terminated effective as of February 25, 2023.
Under the terms of the I-Mab License Agreement, I-Mab paid the Company an upfront payment of $15.0 million, and $5.0 million of milestone revenue has been earned from the inception of the I-Mab License Agreement through termination of the agreement.
The Company evaluated the I-Mab License Agreement under the provisions of ASC 606 and identified a single performance obligation. The Company determined that the $15.0 million upfront payment from I-Mab constituted the entirety of the consideration to be included in the transaction price as of the outset of the arrangement for the license and related research and development activities. The Company reassessed the transaction price as it became probable that a significant reversal of cumulative revenue would not occur for a $5.0 million milestone ($4.5 million after netting a one-time credit as described above) related to development progress of enoblituzumab, therefore the associated consideration was added to the estimated transaction price and was recognized as revenue during 2021.
    Revenue under the I-Mab License Agreement was recognized using a cost-based input method according to costs incurred to date compared to estimated total costs. The transfer of control occurs over this time period and, in management’s judgment, was the best measure of progress towards satisfying the performance obligations. During the three and nine months ended September 30, 2023, the Company recognized no revenue under the I-Mab License Agreement. During the three and nine months ended September 30, 2022, the Company recognized revenue of $3.8 million and $4.5 million, respectively, under the I-Mab License Agreement.

Manufacturing Services Agreement
Incyte
In January 2022, the Company entered into a Manufacturing and Clinical Supply Agreement with Incyte (Incyte Manufacturing and Clinical Supply Agreement) to provide manufacturing services to produce certain Incyte bulk drug substance over a three-year period at one of the Company’s manufacturing facilities. Under the terms of the Incyte Manufacturing and Clinical Supply Agreement, the Company received an upfront payment of $10.0 million and is eligible to
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receive annual fixed payments paid quarterly over the term of the contract totaling $14.4 million. The Company will also be reimbursed for materials used to manufacture product as well as other costs incurred to provide manufacturing services. In July 2022, the Company and Incyte executed an amendment to the Incyte Manufacturing and Clinical Supply Agreement which extended the term for one year and provided for an additional annual fixed payment of $5.1 million (July 2022 Incyte Amendment).
The Company evaluated the Incyte Manufacturing and Clinical Supply Agreement and the July 2022 Incyte Amendment under the provisions of ASC 606 and identified one performance obligation to provide manufacturing runs to Incyte, as and when requested by Incyte, over the term of the contract that is part of a series of goods and services. The Company determined that the transaction price consists of the upfront payment received of $10.0 million and the annual fixed payments totaling $19.5 million. The Company will recognize revenue over time on a straight-line basis as the manufacturing services are provided to Incyte, as the Company determined that its efforts in providing the manufacturing services will be incurred evenly throughout the performance period and therefore straight-line revenue recognition closely approximates the level of effort for the manufacturing services. Variable consideration relating to the reimbursed materials and other reimbursed costs incurred to manufacture product for Incyte will be allocated to the related manufacturing activities and will be recognized as revenue as those activities occur. Materials purchased by the Company to manufacture the product for Incyte are considered costs to fulfill a contract and will be capitalized and expensed as the materials are used to provide the manufacturing services.
During the three months ended September 30, 2023 and 2022, the Company recognized revenue of $4.5 million and $1.1 million, respectively, under the Incyte Manufacturing and Clinical Supply Agreement. During the nine months ended September 30, 2023 and 2022 the Company recognized revenue of $9.6 million and $5.1 million, respectively, under the Incyte Manufacturing and Clinical Supply Agreement. As of September 30, 2023, $7.0 million in revenue was deferred under this agreement, $6.4 million of which was current and $0.6 million of which was non-current.
Government Agreement
NIAID Contract
The Company entered into a contract with NIAID, effective as of September 15, 2015, to perform product development and to advance up to two DART molecules, MGD014 and MGD020 (NIAID Contract). Under the NIAID Contract, the Company will develop these product candidates for Phase 1/2 clinical trials as therapeutic agents, in combination with latency reversing treatments, to deplete cells infected with human immunodeficiency virus (HIV) infection. NIAID does not receive goods or services from the Company under this contract, therefore the Company does not consider NIAID to be a customer and concluded this contract is outside the scope of ASC 606.
Since the inception of the NIAID Contract, NIAID has exercised the two options contemplated in the original contract and executed modifications such that the total funded contract value as of September 30, 2023 is $25.1 million. In addition, the most recent modification changed the period of performance under the NIAID Contract to end in September 2024. During the three months ended September 30, 2023 and 2022, the Company recognized revenue under the NIAID Contract of $0.3 million and $0.5 million, respectively . During the nine months ended September 30, 2023 and 2022, the Company recognized revenue under the NIAID Contract of $1.1 million and $1.5 million, respectively.

9. Stock-Based Compensation
Employee Stock Purchase Plan
In May 2017, the Company’s stockholders approved the 2016 Employee Stock Purchase Plan (the 2016 ESPP). The 2016 ESPP is structured as a qualified employee stock purchase plan under Section 423 of the Internal Revenue Code of 1986, as amended (IRC), and is not subject to the provisions of the Employee Retirement Income Security Act of 1974. The Company reserved 800,000 shares of common stock for issuance under the 2016 ESPP. The 2016 ESPP allows eligible employees to purchase shares of the Company’s common stock at a discount through payroll deductions of up to 10% of their eligible compensation, subject to any plan limitations. The 2016 ESPP provides for six-month offering periods ending on May 31 and November 30 of each year. At the end of each offering period, employees are able to purchase shares at 85% of the fair market value of the Company’s common stock on the last day of the offering period. During the nine months ended September 30, 2023, 48,280 shares of common stock were purchased under the 2016 ESPP.
Employee Stock Incentive Plans
Effective February 2003, the Company implemented the 2003 Equity Incentive Plan (2003 Plan), and it was amended and approved by the Company's stockholders in 2005. Stock options granted under the 2003 Plan may be either incentive stock options as defined by the IRC, or non-qualified stock options. In 2013, the 2003 Plan was terminated, and no further awards
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may be issued under the plan. Any shares of common stock subject to awards under the 2003 Plan that expire, terminate, or are otherwise surrendered, canceled, forfeited or repurchased without having been fully exercised, or resulting in any common stock being issued, will become available for issuance under the 2013 Equity Incentive Plan (2013 Plan), up to a specified number of shares.
In October 2013, the Company implemented the 2013 Plan. The 2013 Plan provides for the grant of stock options and other stock-based awards, as well as cash-based performance awards. In May 2023, the 2013 Plan was terminated, and no further awards may be issued under the plan. If an option granted under the 2013 Plan expires or terminates for any reason without having been fully exercised, if any shares of restricted stock are forfeited, or if any award terminates, expires or is settled without all or a portion of the shares of common stock covered by the award being issued, such shares will become available for issuance under the 2023 Equity Incentive Plan (2023 Plan).
The 2023 Plan was effective as of stockholder approval in May 2023. The 2023 Plan provides for grants of stock options and other stock-based awards, as well as cash-based performance awards. Initially, the maximum number of shares of the Company’s common stock that may be issued under the 2023 Plan will not exceed 4,850,000 shares. If an option expires or terminates for any reason without having been fully exercised, if any shares of restricted stock are forfeited, or if any award terminates, expires or is settled without all or a portion of the shares of common stock covered by the award being issued, such shares are available for the grant of additional awards. However, any shares that are withheld (or delivered) to pay withholding taxes or to pay the exercise price of an option are not available for the grant of additional awards.
The following stock-based compensation expense was recognized for the periods indicated (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,
2023202220232022
Research and development$2,335 $2,571 $6,996 $7,621 
Selling, general and administrative2,455 2,552 7,018 8,076 
Total stock-based compensation expense$4,790 $5,123 $14,014 $15,697 
Employee stock options
The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing model using the assumptions in the following table for options issued during the period indicated:
Nine Months Ended September 30,
20232022
Expected dividend yield0%0%
Expected volatility
76.1% -94.9%
87.8% - 90.8%
Risk-free interest rate
3.5% - 4.4%
1.4% - 3.6%
Expected term5.88 years5.95 years
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The following table summarizes stock option activity during the nine months ended September 30, 2023:
SharesWeighted-
Average
Exercise Price
Weighted-Average
Remaining
Contractual Term
(Years)
Aggregate
Intrinsic
Value
 (in thousands)
Outstanding, December 31, 202210,098,929 $18.58 6.5
Granted3,267,727 4.91 
Exercised(26,146)3.34 
Forfeited(293,161)9.78 
Expired(367,054)19.77 
Outstanding, September 30, 202312,680,295 15.26 6.7$301 
As of September 30, 2023:
Exercisable7,836,655 19.50 5.4186 
Vested and expected to vest11,733,021 15.75 6.5278 
The weighted-average grant-date fair value of options granted during the nine months ended September 30, 2023 and 2022 was $3.78 and $6.89, respectively. The total intrinsic value of options exercised during the nine months ended September 30, 2023 and 2022 was $0.1 million and $0.5 million, respectively. The total cash received for options exercised during the nine months ended September 30, 2023 and 2022 was $0.1 million and $0.3 million, respectively. The total fair value of shares vested in the nine months ended September 30, 2023 and 2022 was approximately $13.6 million and $15.1 million, respectively. As of September 30, 2023, the total unrecognized compensation expense related to unvested stock options, net of related forfeiture estimates, was approximately $22.6 million, which the Company expects to recognize over a weighted-average period of approximately 1.3 years.
Restricted Stock Units
The Company awards restricted stock units (RSUs) to employees. RSUs are valued based on the closing price of the Company’s common stock on the date of the grant. The fair value of RSUs is recognized and amortized on a straight-line basis over the requisite service period of the award.
The following table summarizes RSU activity during the nine months ended September 30, 2023:
Shares
Weighted-Average
Grant Date Fair Value
Outstanding, December 31, 2022415,084 $8.83 
Granted696,635 4.84 
Vested(135,396)8.32 
Forfeited(68,046)7.53 
Outstanding, September 30, 2023908,277 5.95 

At September 30, 2023, there was $2.9 million of total unrecognized compensation cost related to unvested RSUs, which the Company expects to recognize over a remaining weighted-average period of approximately 1.3 years.

10. In-licensing arrangement
In January 2022, the Company entered into a non-exclusive license agreement with Synaffix B.V., a Lonza company, (Synaffix) to develop, manufacture and commercialize up to three antibody-drug conjugate targets using Synaffix’s proprietary technology. The Company made an upfront payment to Synaffix upon contract execution. In March 2023, the Company and Synaffix amended the agreement, adding four additional targets. Assuming all seven targets are successfully developed and commercialized, the Company would be obligated to pay up to $2.8 billion for development, regulatory and sales milestones. Finally, pursuant to the terms of this license agreement, as amended, upon commencement of commercial sales of any products developed from these targets, the Company would be required to pay Synaffix tiered royalties in the low‑single digit percentages on net sales of the respective products. The Company may terminate this agreement at any time with 30 days’ notice to Synaffix. Amounts paid to Synaffix under this agreement are recorded as research and development expense in the
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consolidated statement of operations. No expense was incurred under this agreement during the three months ended September 30, 2023 or 2022. The Company incurred $1.7 million and $1.0 million in expense under this agreement during the nine months ended September 30, 2023 and 2022, respectively.

11 . Net Income (Loss) Per Share
Basic income (loss) per common share is determined by dividing income (loss) attributable to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration of common stock equivalents. Diluted income (loss) per share is computed by dividing the income (loss) attributable to common stockholders by the weighted-average number of common stock equivalents outstanding for the period. The treasury stock method is used to determine the dilutive effect of the Company's stock option grants and RSUs. 12,607,056 and 12,514,638 stock options and RSUs (common stock equivalents) were excluded from the calculation of diluted income per share for the three and nine months ended September 30, 2023, respectively, because their inclusion would have been anti-dilutive.

Basic and diluted income (loss) per common share is computed as follows (in thousands except share and per share data):
Three Months Ended September 30,Nine Months Ended September 30,
2023202220232022
Numerator:
Net income (loss) used for calculation of basic and diluted EPS$17,554 $(24,813)$37,014 $(132,560)
Denominator:
Weighted average shares outstanding, basic61,980,680 61,459,831 61,890,824 61,390,143 
Effect of dilutive securities:
Stock options and restricted stock units263,922  199,519  
Weighted average shares outstanding, diluted62,244,602 61,459,831 62,090,343 61,390,143 
Net income (loss) per share, basic$0.28 $(0.40)$0.60 $(2.16)
Net income (loss) per share, diluted$0.28 $(0.40)$0.60 $(2.16)


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ITEM 2.MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion of our financial condition and results of operations is based upon our unaudited consolidated financial statements included in this Quarterly Report on Form 10-Q, which have been prepared by us in accordance with U.S. generally accepted accounting principles (GAAP), for interim periods and with Regulation S-X promulgated under the Securities Exchange Act of 1934, as amended. This discussion and analysis should be read in conjunction with these unaudited consolidated financial statements and the notes thereto as well as in conjunction with our audited consolidated financial statements and related notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2022. 

Overview
We are a biopharmaceutical company focused on developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer. We have a pipeline of product candidates being evaluated in clinical trials sponsored by us or our collaborators in addition to several molecules in preclinical development. Our clinical product candidates include multiple oncology programs, many of which were created using our proprietary, antibody-based technology platforms. We believe our product candidates have the potential, if approved for marketing by regulatory authorities, to have a meaningful effect on treating patients' unmet medical needs as monotherapy or, in some cases, in combination with other therapeutic agents. To date, three products originating from our pipeline of proprietary or partnered product candidates have received U.S. Food and Drug Administration (FDA) approval. In March 2021, we and our commercialization partner commenced U.S. marketing of MARGENZA (margetuximab-cmkb), a human epidermal growth factor receptor 2 (HER2) receptor antagonist indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. In November 2022, the FDA approved TZIELD® (teplizumab-mzwv) to delay the onset of Stage 3 Type 1 Diabetes (T1D) in adult and pediatric patients aged 8 years and older with Stage 2 T1D. Teplizumab was acquired from us by Provention Bio, Inc. (Provention) in 2018, pursuant to an asset purchase agreement. In March 2023, the FDA approved ZYNYZ™ (retifanlimab-dlwr), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1). Retifanlimab was previously developed by us and licensed to Incyte Corporation (Incyte) pursuant to an exclusive global collaboration and license agreement in October 2017.
Our operations to date have concentrated on developing our technology platforms, identifying potential product candidates, undertaking preclinical studies, conducting clinical trials, developing collaborations, operating manufacturing facilities, business planning and raising capital. We only began generating revenues from the sale of products in 2021. We have financed our operations primarily through the public and private offerings of our securities and collaborations with other biopharmaceutical companies. Although it is difficult to predict our funding requirements, we anticipate that our cash, cash equivalents and marketable securities as of September 30, 2023, combined with anticipated and potential collaboration payments, product revenue, contract manufacturing revenue, and royalties, should enable us to fund our operations into 2026. Our expected funding requirements reflect anticipated expenditures related to the Phase 2 TAMARACK clinical trial of vobramitamab duocarmazine (vobra duo) in metastatic castration-resistant prostate cancer (mCRPC), our Phase 2 LORIKEET study of lorigerlimab in mCRPC as well as our other clinical and preclinical studies currently ongoing.
Through September 30, 2023, we had an accumulated deficit of $1.1 billion. We expect that over the next several years this deficit will increase as we continue to incur research and development expense in connection with our ongoing activities and several clinical studies. 
Macroeconomic Conditions
The global economy, credit markets and financial markets have and may continue to experience significant volatility as a result of significant worldwide events, including adverse events involving financial institutions or the financial services industry, inflation and rising interest rates and geopolitical upheaval (collectively, the Macroeconomic Conditions). These Macroeconomic Conditions have and may continue to create supply chain disruptions, inventory disruptions, and fluctuations in economic growth, including fluctuations in employment rates, inflation, energy prices and consumer sentiment. It remains difficult to assess or predict the ultimate duration and economic impact of the Macroeconomic Conditions. Prolonged uncertainty with respect to Macroeconomic Conditions could cause further economic slowdown or cause other unpredictable events, each of which could adversely affect our business, results of operations or financial condition.

Collaborations
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We pursue a balanced approach between product candidates that we develop ourselves and those that we develop with our collaborators. Under our strategic collaborations to date, we have received significant non-dilutive funding and continue to have rights to additional funding upon completion of certain research, achievement of key product development milestones and royalties and other payments upon the commercial sale of products. Our current collaborations include the following:
Incyte. We have an exclusive global collaboration and license agreement with Incyte for retifanlimab, an investigational monoclonal antibody that inhibits PD-1 (Incyte License Agreement). Under this agreement, as amended, Incyte has obtained exclusive worldwide rights for the development and commercialization of retifanlimab in all indications, while we retain the right to develop our pipeline assets in combination with retifanlimab. We received an upfront payment of $150.0 million and milestone payments totaling $115.0 million from Incyte through September 30, 2023, including $15.0 million upon the FDA approval of ZYNYZ (retifanlimab-dlwr) in March 2023. We are eligible to receive an additional $320.0 million in development and regulatory milestones and $330.0 million in commercial milestones. We are also eligible to receive tiered royalties of 15% to 24% on any global net sales and we have the option to co-promote retifanlimab with Incyte. We retain the right to develop our pipeline assets in combination with retifanlimab, with Incyte commercializing retifanlimab and us commercializing our asset(s), if any such potential combinations are approved. We also have an agreement with Incyte under which we are to perform development and manufacturing services for Incyte's clinical needs of retifanlimab (Incyte Clinical Supply Agreement) and another agreement under which we are entitled to manufacture a portion of Incyte’s global commercial supply of retifanlimab (Incyte Commercial Supply Agreement).
Gilead. In October 2022, we and Gilead Sciences, Inc. (Gilead) entered into an exclusive option and collaboration agreement (Gilead Agreement) to develop and commercialize MGD024 and create bispecific cancer antibodies using our DART platform and undertake their early development under a maximum of two separate bispecific cancer target research programs. Under the Gilead Agreement, we will continue the ongoing phase 1 trial for MGD024 according to a development plan, during which Gilead will have the right to exercise an option granted to Gilead to obtain an exclusive license to develop and commercialize MGD024 and other bispecific antibodies of ours that bind CD123 and CD3 (CD123 Option). The agreement also grants Gilead the right, within its first two years, to nominate a bispecific cancer target set for up to two research programs conducted by us and to exercise separate options to obtain an exclusive license for the development, commercialization and exploitation of molecules created under each research program (Research Program Option). As part of the Gilead Agreement, Gilead paid us a non-refundable upfront payment of $60.0 million and we will be eligible to receive up to $1.7 billion in target nomination, option fees, and development, regulatory and commercial milestones, assuming Gilead exercises the CD123 Option and Research Program Option, successfully develops and commercializes MGD024 or other CD123 products developed under the agreement, and products result from the two additional research programs. Assuming exercise of the CD123 Option, we will also be eligible to receive tiered, low double-digit royalties on worldwide net sales of MGD024 (or other CD123 products developed under the agreement) and assuming exercise of the Research Program Option, a flat royalty on worldwide net sales of any products resulting from the two research programs. In September 2023, Gilead nominated the first of the two research programs contemplated in the Gilead Agreement (First Research Program), we granted Gilead a research license, and the parties agreed on a research plan for the First Research Program under which we will provide research and development services. Gilead paid us a $15.7 million nomination fee, which we received in October 2023.
Zai Lab. In 2018, we entered into a collaboration and license agreement with Zai Lab Limited (Zai Lab) under which Zai Lab obtained regional development and commercialization rights in mainland China, Hong Kong, Macau and Taiwan (Zai Lab’s territory) for (i) margetuximab, an immune-optimized anti-HER2 monoclonal antibody, (ii) tebotelimab, a bispecific DART molecule designed to provide coordinate blockade of PD-1 and LAG-3 for the potential treatment of a range of solid tumors and hematological malignancies, and (iii) an undisclosed multi-specific TRIDENT molecule in preclinical development (2018 Zai Lab Agreement). Zai Lab will lead clinical development in its territory. Zai Lab has informed us that they have decided to discontinue development of tebotelimab for indications they were enrolling in their territory and is evaluating future development plans in other indications.
Under the terms of the 2018 Zai Lab Agreement, Zai Lab paid us an upfront payment of $25.0 million less foreign withholding tax of $2.5 million. Assuming successful development and commercialization of margetuximab, tebotelimab and the TRIDENT molecule, we could receive up to $140.0 million in development and regulatory milestones, of which we have earned and received $9.0 million through September 30, 2023. In addition, Zai Lab
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would pay us tiered royalties at percentage rates of mid-teens to 20% for net sales of margetuximab in Zai Lab’s territory, mid-teens for net sales of tebotelimab in Zai Lab’s territory and 10% for net sales of the TRIDENT molecule in Zai Lab’s territory, which may be subject to adjustment in specified circumstances.
Provention. In 2018, we entered into an asset purchase agreement (Provention APA) pursuant to which Provention acquired our interest in teplizumab. Under the Provention APA, if Provention successfully develops, obtains regulatory approval for, and commercializes teplizumab, we will be eligible to receive up to $170.0 million in regulatory milestones, and up to $225.0 million in commercial milestones. In November 2022, the FDA approved TZIELD (teplizumab-mzwv) to delay the onset of Stage 3 T1D in adult and pediatric patients aged 8 years and older with Stage 2 T1D, and we recognized $60.0 million in milestone revenue during the year ended December 31, 2022. In November 2022 we and Provention amended the Provention APA. Under the amended Provention APA, the $60.0 million milestone for a first approval was split into four $15 million payments, all of which were received prior to June 30, 2023. Under the Provention APA we are also eligible to receive single-digit royalties on net sales of TZIELD. Provention has also agreed to pay third-party obligations, including low single-digit royalties, a portion of which is creditable against royalties payable to us, aggregate milestone payments of up to approximately $1.3 million and other consideration, for certain third-party intellectual property under agreements Provention assumed pursuant to the Provention APA. Further, Provention is required to pay us a low double-digit percentage of certain consideration to the extent it is received in connection with a grant of rights by Provention to a third party.
In March 2023, we sold our single-digit royalty interest in TZIELD (Royalty Interest) to a wholly-owned subsidiary of DRI Healthcare Trust (DRI) and received a $100.0 million payment from DRI under a Royalty Purchase Agreement. We retain our other economic interests related to TZIELD, including future potential regulatory and commercial milestones. We retain the right to receive a 50% share of the royalty on global net sales above a certain annual threshold (Retained Interest). In addition, we received $50.0 million upon the occurrence of the primary endpoint milestone event in September 2023, and we are also eligible to receive an additional $50.0 million if TZIELD achieves a certain level of net sales (the Sales Milestone Payment). In April 2023, we entered into an agreement (the Tripartite Agreement) with DRI and a subsidiary of Sanofi S.A. (Sanofi), whereby we consented to the sale of DRI’s Royalty Interest and the related milestone payment obligations to Sanofi. The Tripartite Agreement eliminated our obligation to deliver payments to DRI related to the Royalty Interest and removed all of our other obligations under the Royalty Purchase Agreement. The Royalty Interest will be paid directly to Sanofi by Provention, therefore we no longer have any obligation to pay DRI. There was no modification to our Retained Interest in the Tripartite Agreement.
In September 2023, we and Sanofi executed Amendment No. 2 to the Provention APA to incorporate the Sales Milestone Payment obligation from the Royalty Purchase Agreement into the Provention APA and terminated the Royalty Purchase Agreement. As a result, the remaining $50.0 million Sales Milestone Payment under the Royalty Purchase Agreement was incorporated into the Provention APA.


Critical Accounting Estimates
Our critical accounting estimates are policies which require the most significant judgments and estimates in the preparation of our consolidated financial statements. A summary of our critical accounting estimates is presented in Part II, Item 7, "Management's Discussion and Analysis of Financial Condition and Results of Operations" of our Annual Report on Form 10-K for the year ended December 31, 2022. The following accounting policies and estimates were deemed critical during the nine months ended September 30, 2023:

Liability related to the sale of future royalties and related interest expense
The liability related to future royalties is presented net of unamortized issuance costs on our consolidated balance sheets. Interest expense on the liability related to future royalties is recognized using the effective interest rate method over the life of the arrangement. We calculate an effective interest rate which will amortize our related obligation to zero over the anticipated repayment period. The liability related to future royalties and the related interest expense are based on our current estimates of future royalties expected to be received over the life of the arrangement, which we determine by using internal sales projections and external information from market data sources, which are considered Level 3 inputs. We periodically assess the expected payments and to the extent our estimates of future royalty payments are greater or less than previous estimates or the estimated timing of such payments is materially different than previous estimates, we will adjust the effective interest rate and recognize related non-cash interest expense on a prospective basis.
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Upon changes in facts and circumstances, for example as a result of a modification to the existing agreements, we re-evaluate our rights and obligations and account for the change in accordance with the respective accounting guidance.

Results of Operations
Revenue
The following represents a comparison of our revenue for the three and nine months ended September 30, 2023 and 2022 (dollars in millions):
Three Months Ended September 30,Nine Months Ended September 30,
20232022Change %20232022Change%
Collaborative and other agreements$0.9 $35.7 $(34.8)(98)%$23.6 $59.6 $(36.0)(60)%
Product sales, net4.7 4.4 0.3 %13.2 12.6 0.6 %
Contract manufacturing 4.5 1.1 3.4 309 %9.7 5.1 4.6 90 %
Royalty revenue*— — N/A0.4 — 0.4 N/A
Government agreements0.3 0.5 (0.2)(40)%1.1 1.5 (0.4)(27)%
Total revenue$10.4 $41.7 $(31.3)(76)%$48.0 $78.8 $(30.8)(39)%
* Represents revenue of less then $0.1 million.
The decrease in revenue of $31.3 million for the three months ended September 30, 2023 compared to the three months ended September 30, 2022 was primarily due to:
recognition of $30.0 million in milestone payments under the Incyte License Agreement during the three months ended September 30, 2022;
a decrease of $3.8 million in revenue recognized under the I-Mab License Agreement; and
a decrease of $1.8 million in revenue recognized under the 2021 Zai Lab Agreement.
These decreases were partially offset by an increase of $3.3 million in revenue recognized under the Incyte Manufacturing and Clinical Supply Agreement.
The decrease in revenue of $30.8 million for the nine months ended September 30, 2023 compared to the nine months ended September 30, 2022 was primarily due to:
a decrease of $16.8 million in revenue recognized under the 2021 Zai Lab Agreement;
a decrease of $15.0 million in milestone payments under the Incyte License Agreement;
a decrease of $4.9 million in revenue recognized under the 2018 Zai Lab Agreement;
a decrease of $4.5 million in revenue recognized under the I-Mab License Agreement; and
a decrease of $1.4 million in revenue recognized under the I-Mab Clinical Supply Agreement.
These decreases were partially offset by:
an increase of $5.5 million in revenue recognized under the Provention APA;
an increase of $4.5 million in revenue recognized under the Incyte Manufacturing and Clinical Supply Agreement;
an increase of $1.1 million in revenue recognized under the Gilead Agreement; and
an increase of $1.1 million in revenue recognized under the Incyte Clinical Supply Agreement.
Revenue from collaborative and other agreements may vary substantially from period to period depending on the progress made by our collaborators with their product candidates and the timing of milestones achieved under current agreements, and whether we enter into additional collaboration agreements.
Cost of Product Sales
Cost of product sales for all periods presented consists primarily of product royalties and fill finish costs. Product sold during these periods consisted of drug product that was previously charged to research and development expense prior to FDA
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approval of MARGENZA, which favorably impacted our gross margin. We expect cost of product sales to continue to be positively impacted as we sell through this drug product.
Cost of Manufacturing Services
Cost of manufacturing services consists of the costs to provide manufacturing services to produce certain Incyte bulk drug substance under the Incyte Manufacturing and Clinical Supply Agreement. We expect cost of manufacturing services to vary from period to period based on the agreed-upon manufacturing schedule.
Research and Development Expense
The following represents a comparison of our research and development expense for the three and nine months ended September 30, 2023 and 2022 (dollars in millions):
Three Months Ended September 30,Nine Months Ended September 30,
20232022Change%20232022Change%
Antibody-drug conjugates (ADCs) (a)$7.9 $6.3 $1.6 25 %$25.2 $13.0 $12.2 94 %
Vobramitamab duocarmazine6.5 10.1 (3.6)(36)%28.0 37.6 (9.6)(26)%
Lorigerlimab6.2 4.9 1.3 27 %21.6 14.6 7.0 48 %
Margetuximab3.3 6.9 (3.6)(52)%12.9 22.6 (9.7)(43)%
Next-generation T-cell engagers (b)2.1 1.2 0.9 75 %8.1 13.2 (5.1)(39)%
MGD0241.2 2.1 (0.9)(43)%4.6 6.1 (1.5)(25)%
IMGC9360.8 1.4 (0.6)(43)%2.4 6.2 (3.8)(61)%
Tebotelimab0.7 1.9 (1.2)(63)%5.3 9.3 (4.0)(43)%
DART molecules under HIV government contract0.5 1.8 (1.3)(72)%1.7 3.6 (1.9)(53)%
Retifanlimab0.2 0.2 — — %0.7 1.9 (1.2)(63)%
Enoblituzumab0.1 3.7 (3.6)(97)%2.3 12.5 (10.2)(82)%
Flotetuzumab— 1.5 (1.5)(100)%2.7 10.8 (8.1)(75)%
Other programs (b)0.6 6.2 (5.6)(90)%3.7 10.0 (6.3)(63)%
Total research and development expense$30.1 $48.2 $(18.1)(38)%$119.2 $161.4 $(42.2)(26)%
(a) Includes MGC026 and other preclinical ADCs.
(b) Includes research and discovery projects, as well as early preclinical molecules and molecules not advanced to clinical development.
Our research and development expense for the three months ended September 30, 2023 decreased by $18.1 million compared to the three months ended September 30, 2022 primarily due to:
decreased development and clinical trial costs related to margetuximab, including expenses under the 2018 Zai Lab Agreement;
decreased development, manufacturing and clinical trial costs related to enoblituzumab;
decreased development and vobra duo clinical trial costs;
decreased development and clinical trial costs related to flotetuzumab due to discontinued development of this molecule;
decreased development, manufacturing and clinical trial costs related to tebotelimab; and
decreased development costs related to other programs;.
These decreases were partially offset by:
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increased research and development costs related to preclinical ADC product candidates; and
increased clinical trial costs related to lorigerlimab.
Our research and development expense for the nine months ended September 30, 2023 decreased by $42.2 million compared to the nine months ended September 30, 2022 primarily due to:
•    decreased development, manufacturing and clinical trial costs related to enoblituzumab;
decreased development and clinical trial costs related to margetuximab, including expenses under the 2018 Zai Lab Agreement;
decreased manufacturing related costs for vobra duo;
decreased development and clinical trial costs related to flotetuzumab due to discontinued development of this molecule;
decreased research and development costs related to next-generation T-cell engagers under the discontinued 2021 Zai Lab Agreement lead program;
decreased development, manufacturing and clinical trial costs related to tebotelimab;
decreased development costs related to other programs.
These decreases were partially offset by:
•    increased research and development costs related to preclinical ADC product candidates; and
•    increased clinical trial costs related to lorigerlimab.
There are uncertainties associated with our research and development expenses for future quarters which are impacted by multiple variables, including timing of wind down activities for recently closed studies and current and expected expenditures associated with our ongoing clinical studies.
Selling, General and Administrative Expense
Selling, general and administrative expenses decreased by $3.0 million for the three months ended September 30, 2023 compared to the three months ended September 30, 2022, and decreased by $5.6 million for the nine months ended September 30, 2023 compared to the nine months ended September 30, 2022 primarily due to decreased MARGENZA-related selling expenses.

Gain on Royalty Monetization Arrangement
In April 2023, we entered into the Tripartite Agreement with DRI and Sanofi, whereby we consented to the sale of DRI’s Royalty Interest and the related milestone payment obligations to Sanofi. The execution of the Tripartite Agreement resulted in a modification to the liability related to future royalties, and we recognized a $100.9 million gain on royalty monetization arrangement. In July 2023, Sanofi reported achievement of the primary endpoint milestone event related to a $50.0 million milestone, which resulted in an additional $50.0 million gain on royalty monetization arrangement. In September 2023, we amended the Provention APA and terminated the Royalty Purchase Agreement with DRI. See Note 6, Royalty Monetization Arrangement, of the Notes to Consolidated Financial Statements, for additional information.

Liquidity and Capital Resources
Cash Flows
The following table represents a summary of our cash flows for the nine months ended September 30, 2023 and 2022:
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Nine Months Ended September 30,
20232022
(dollars in millions)
Net cash provided by (used in):
Operating activities$(50.2)$(116.3)
Investing activities(118.9)76.5 
Financing activities150.1 0.3 
Net change in cash and cash equivalents$(19.0)$(39.5)
Operating Activities
Net cash used in operating activities consists of our net loss adjusted for non-cash items such as depreciation and amortization expense and stock-based compensation, gain on royalty monetization arrangement which is classified as a financing activity, and changes in working capital. Net cash used in operating activities for the nine months ended September 30, 2023 benefited from $15.0 million in milestones received from Incyte under the Incyte License Agreement. Net cash used in operating activities for the nine months ended September 30, 2022 benefited from $30.0 million in milestones received from Incyte under the Incyte License Agreement, $12.3 million received from Incyte under the Incyte Manufacturing and Clinical Supply Agreement and $4.5 million (after netting value-added tax withholding) in milestones received under the 2018 Zai Lab Agreement.
Investing Activities
Net cash used in investing activities during the nine months ended September 30, 2023 is primarily due to purchases of marketable securities, partially offset by maturities of marketable securities. Net cash provided by investing activities during the nine months ended September 30, 2022 is primarily due to maturities of marketable securities, partially offset by purchases of marketable securities.
Financing Activities
Net cash provided by financing activities for the nine months ended September 30, 2023 includes net cash proceeds from our Royalty Purchase Agreement with DRI of $149.7 million.
Our multiple product candidates currently under development will require significant additional research and development efforts that include extensive preclinical studies and clinical testing, and regulatory approval prior to commercial use. Our future success is dependent on our ability to identify and develop our product candidates, and ultimately upon our ability to attain profitable operations. We have devoted substantially all of our financial resources and efforts to research and development and general and administrative expense to support such research and development. Net losses and negative cash flows have had, and will continue to have, an adverse effect on our stockholders’ equity and working capital, and accordingly, our ability to execute our future operating plans.
As a biotechnology company, we have primarily funded our operations with proceeds from the sale of our common stock in equity offerings and revenue from our multiple collaboration agreements. Management regularly reviews our available liquidity relative to our operating budget and forecast to monitor the sufficiency of our working capital, and anticipates continuing to draw upon available sources of capital, including equity and debt instruments, to support our product development activities. There can be no assurances that new sources of capital will be available to us on commercially acceptable terms, if at all. Also, any future collaborations, strategic alliances and marketing, distribution or licensing arrangements may require us to give up some or all rights to a product or technology at less than its full potential value. If we are unable to enter into new arrangements or to perform under current or future agreements or obtain additional capital, we will assess our capital resources and may be required to delay, reduce the scope of, or eliminate one or more of our product research and development programs or clinical studies, and/or downsize our organization. Although it is difficult to predict our funding requirements, we anticipate that our cash, cash equivalents and marketable securities as of September 30, 2023 combined with anticipated and potential collaboration payments, product revenue, contract manufacturing revenue, and royalties, should enable us to fund our operations into 2026. Our expected funding requirements reflect anticipated expenditures related to the Phase 2 TAMARACK clinical trial of vobra duo in mCRPC, our Phase 2 study of lorigerlimab in mCRPC as well as our other clinical and preclinical studies currently ongoing.
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Material Cash Requirements
During the nine months ended September 30, 2023, there were no significant changes to our material cash requirements, including contractual and other obligations, as presented in 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 fiscal year ended December 31, 2022.

ITEM 3.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
 Under SEC rules and regulations, because we are considered to be a “smaller reporting company," we are not required to provide the information required by this item in this Quarterly Report on Form 10-Q.

ITEM 4.CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
Our management, including our principal executive officer and principal financial officer, has evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2023. Our disclosure controls and procedures are designed to provide reasonable assurance that the information required to be disclosed in our periodic reports filed with the SEC (such as this Quarterly Report on Form 10-Q) has been appropriately recorded, processed, summarized and reported within the time periods specified in the SEC's rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, to allow timely decisions regarding required disclosure. Based on their evaluation of our disclosure controls and procedures as of September 30, 2023, our principal executive officer and principal financial officer have concluded that our disclosure controls and procedures are effective at the reasonable assurance level.
Changes in Internal Control
There were no changes in our internal control over financial reporting during the three months ended September 30, 2023 that materially affected, or are reasonably likely to materially effect, our internal control over financial reporting.

PART II. OTHER INFORMATION
Item 1. Legal Proceedings
In the ordinary course of business, we are or may be involved in various legal or regulatory proceedings, claims or class actions related to alleged patent infringements and other intellectual property rights, or alleged violation of commercial, corporate, securities, labor and employment, and other matters incidental to our business. We do not currently, however, expect such legal proceedings to have a material adverse effect on our business, financial condition or results of operations. However, depending on the nature and timing of a given dispute, an eventual unfavorable resolution could materially affect our current or future results of operations or cash flows.

Item 1A.Risk Factors
Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and trading price of our securities. In addition to the other information set forth in this Quarterly Report on Form 10-Q, you should carefully consider the factors described in Part I, Item 1A. “ Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2022. There have been no material changes in the risk factors described in “Item 1A. Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2022.

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Item 6.Exhibits
10.1+
31.1*
31.2*
32.1**
32.2**
101.INSXBRL Instance Document
101.SCHXBRL Schema Document
101.CALXBRL Calculation Linkbase Document
101.DEFXBRL Definition Linkbase Document
101.LABXBRL Labels Linkbase Document
101.PREXBRL Presentation Linkbase Document
104Cover Page Interactive Data (formatted as Inline XBRL and contained in Exhibit 101 filed herewith)

+    Portions of this document (indicated by “[***]” have been omitted because they are not material and are the type that
MacroGenics, Inc. treats as private and confidential.
*     Filed herewith
**     Furnished herewith






SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
MACROGENICS, INC.
BY:/s/ Scott Koenig
Scott Koenig, M.D., Ph.D.
President and Chief Executive Officer
(Principal Executive Officer)
BY:/s/ James Karrels
James Karrels
Senior Vice President and Chief Financial Officer
(Principal Financial Officer)
Dated: November 6, 2023


Document

EXHIBIT 10.1

CERTAIN PORTIONS OF THIS EXHIBIT (INDICATED BY [***]) HAVE BEEN EXCLUDED PURSUANT TO ITEM 601(B)(10) OF REGULATION S-K BECAUSE THEY ARE BOTH NOT MATERIAL AND ARE THE TYPE THAT THE COMPANY TREATS AS PRIVATE AND CONFIDENTIAL.
AMENDMENT NO. 2 TO ASSET PURCHASE AGREEMENT

This Amendment No. 2 to the Asset Purchase Agreement (this “Amendment No. 2”), by and between MacroGenics, Inc., a Delaware corporation (“Seller”), Provention Bio, Inc., a Delaware corporation (“Buyer”) and, as to Section 2 g) of this Amendment No. 2 with respect to Section 3.12 of the Agreement (as defined below), Parent (as defined below) and together with Seller and Buyer, the “Parties” and each separately, a “Party”), hereby amends that certain Asset Purchase Agreement, dated as of May 7, 2018, as amended by Amendment No. 1 to the Asset Purchase Agreement, dated November 30, 2022, by and between Seller and Buyer (the “Agreement”). Capitalized terms used and not otherwise defined herein shall have the meanings ascribed to such terms in the Agreement.

WHEREAS, Sanofi, a French société anonyme (“Sanofi”) completed its acquisition of Buyer on April 27, 2023 (the “Provention Acquisition”);

WHEREAS, as a result of the Provention Acquisition, Buyer became and is now a wholly owned subsidiary of Aventis, Inc., a Delaware corporation (“Parent”) and wholly owned subsidiary of Sanofi;

WHEREAS, pursuant to that certain Tripartite Agreement, dated April 27, 2023, by and among Parent, DRI Healthcare Acquisitions LP, a Delaware limited partnership (“DRI”), and Seller, Parent acquired and assumed all of DRI’s rights and obligations under that certain Purchase and Sale Agreement, dated March 8, 2023, by and between DRI and Seller (the “Purchase Agreement”);

WHEREAS, pursuant to that certain Side Letter Agreement, dated April 27, 2023, by and between Parent and Seller (the “Side Letter Agreement”), the parties thereto agreed to enter into, or cause their affiliates to enter into, this Amendment No. 2;

WHEREAS, pursuant to Section 2.5(a)(i) of the Purchase Agreement, achievement of the Primary Endpoint Milestone Event was publicly announced on July 28, 2023, and on August 22, 2023, Parent paid to Seller the Non-Sales Milestone Payment (as defined in the Purchase Agreement) in the amount of $50,000,000; and

WHEREAS, the Parties now desire to enter into this Amendment No. 2.

NOW, THEREFORE, IN CONSIDERATION of the mutual covenants contained herein, and for other good and valuable consideration the receipt and adequacy of which are hereby acknowledged, the Parties agree as follows:

1.This Amendment No. 2 shall be effective on September 19, 2023 (the “Amendment No. 2 Effective Date”).

2.The Parties agree that the Agreement shall be amended from and after the Amendment No. 2 Effective Date as follows:

a) Section 1.1 of the Agreement is amended to add the following defined terms in alphabetical order within Section 1.1:
Guaranteed Obligations” means, collectively, the obligation of Buyer, or any authorized assignee, substitute or successor entity, pursuant to the terms and conditions of this Agreement, to pay the Sales-Based Milestone Payment.

Parent” means Aventis, Inc., a Delaware corporation and wholly owned subsidiary of Sanofi S.A.

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Royalty Reports” means the quarterly reports required to be prepared and delivered by Buyer to Seller pursuant to Section 3.6.

Sales-Based Milestone Event” means the occurrence, [***] on or after [***] equaling, in the [***].

Sales-Based Milestone Payment” means $50,000,000.

Seller Account” means the account set forth on Exhibit 2A hereto or such other account as may be designated by Seller in writing from time to time.

b) Sections 3.2, 3.2(a) and 3.2(b) of the Agreement are hereby deleted and replaced with the following text:

“3.2    Development and Regulatory Milestones. Buyer shall pay (which payments shall not be creditable against any other obligations of Buyer hereunder) a non-refundable payment for each of the milestone events set forth in this Section 3.2 (each a “Development and Regulatory Milestone”), whether the Development and Regulatory Milestone is achieved by Buyer, its Affiliates or Licensees, or any Third Party acting on behalf of Buyer, its Affiliates or Licensees. Payment for each of the Development and Regulatory Milestones shall be made only once regardless of how many times a Product achieves the corresponding Development and Regulatory Milestone, and no payment shall be due for any Development and Regulatory Milestone which is not achieved. The Development and Regulatory Milestones shall be as follows:

Development and Regulatory Milestone
Payment
[***][***]
[***]
[***]
[***][***]
[***]
[***]


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[***][***]


Buyer shall provide Seller with written notice within thirty (30) days after the achievement of the corresponding Development and Regulatory Milestone. The payment pertaining to each Development and Regulatory Milestone shall be made by Buyer to Seller within ninety (90) days after the achievement of the corresponding Development and Regulatory Milestone.”


c)Section 3.3 of the Agreement is hereby deleted and replaced with the following text:

“3.3    Earn-Out.

i.Subject to Sections 3.3(b), (c) and (d), Buyer shall pay to Seller [***] ([***]%) of the aggregate worldwide annual Net Sales of Product by Buyer, its Affiliates or Licensees, or any Third Party acting on behalf of Buyer, its Affiliates or Licensees of all Products that exceed [***] the Earn-Out Term.

ii.If, during a given calendar quarter when a Product is being Commercialized by or on behalf of Buyer, its Affiliates or Licensees in a particular country, there is Generic Competition in such country with respect to a Product, then the earn-out payment payable pursuant to Section 3.3(a) on the Net Sales of Product in such country shall thereafter be reduced to [***] percent ([***]%) of the amounts otherwise payable pursuant to Section 3.3(a) with respect to such Product in such country for such calendar quarter for so long as such Generic Competition remains.

iii.Beginning on the date of the First Commercial Sale of a Product, and thereafter until all payment obligations due in connection with the sale of Product under the Eli Lilly Agreement (as such obligations exist as of the Closing Date) are satisfied, the earn-out due to Seller set forth in Section 3.3(a) shall be reduced dollar-for-dollar by the amount payable by Buyer to Eli Lilly (or its successor in interest) under the Eli Lilly Agreement for the corresponding calendar quarter.

iv.In the event that Buyer enters into a license with Invitrogen in respect of the issue disclosed and further described on Schedule 5.7(vii), Buyer shall be entitled to credit [***] percent ([***]%) of the amount payable to Invitrogen under such license in a given period in connection with such license against the amount payable to Seller under Section 3.3(a) for the corresponding period.”

d)Section 3.4 of the Agreement is hereby deleted and replaced with the following text:


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“3.4    Commercial Milestones. Buyer shall pay a non-creditable, non-refundable milestone payment for each of the milestone events set forth in this Section 3.4 (each a “Commercial Milestone”), whether the Commercial Milestone is achieved by Buyer, its Affiliates or Licensees, or any Third Party acting on behalf of Buyer, its Affiliates or Licensees. Payment for each of the Commercial Milestones shall be made only once regardless of how many times a Product achieves the corresponding Commercial Milestone, and no payment shall be due for any Commercial Milestone which is not achieved. The Commercial Milestones shall be as follows:

Commercial Milestone
Payment
Aggregate worldwide Net Sales of Product that exceed [***] United States dollars ($[***]) based on the aggregate of all Net Sales of Product since the first commercial sale of Product
[***] United States dollars ($[***])
Aggregate worldwide Net Sales of Product that exceed [***] United States dollars ($[***]) based on the aggregate of all Net Sales of Product since the first commercial sale of Product
[***] United States dollars ($[***])
Aggregate worldwide Net Sales of Product that exceed [***] United States dollars ($[***]) based on the aggregate of all Net Sales of Product since the first commercial sale of Product
[***] United States dollars ($[***])
Achievement of Sales-Based Milestone Event
Sales-Based Milestone Payment

Buyer shall provide Seller with written notice within sixty (60) days of Buyer becoming aware of the occurrence of any of the Commercial Milestones (which awareness shall not be deemed to occur prior to twenty (20) days following the end of the fiscal quarter in which such milestone was achieved) and the payment pertaining to such Commercial Milestone, other than the Sales- Based Milestone Payment, which shall be governed by Section 3.4(a), shall be made by Buyer to Seller within ninety (90) days after the end of the calendar year in which such Commercial Milestone is achieved.”

e)The following text is hereby added to the Agreement as a new Section 3.4(a):

“3.4(a) Sales-Based Milestone Payment. If the Sales-Based Milestone Event is achieved, Buyer shall deliver written notice of such achievement to Seller within thirty (30) Business Days following delivery by Buyer to Seller of the Royalty Report in respect of the second calendar quarter contained in the Sales-Based Milestone Measurement Period certifying that the Sales-


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Based Milestone Event has been achieved. Buyer shall pay the Sales-Based Milestone Payment to Seller within ten (10) Business Days following delivery by Buyer of such written notice in immediately available funds by wire transfer to the Seller Account.”

f)Section 3.5 of the Agreement is hereby deleted and replaced with the following text:

“3.5(a) Qualified Consideration. Buyer shall pay Seller an amount equal to [***] percent ([***]%) of all Qualified Consideration received pursuant to any Qualified Consideration Agreement; provided that if Buyer or its Affiliates enter into the Qualified Consideration Agreement after the Completion of the first Phase III Clinical Trial for a Product, then all such amounts paid to Seller shall be creditable against future milestones (other than the Sales-Based Milestone Payment) related to the applicable Product which are due to Seller in accordance with Section 3.2 or Section 3.4 (other than Section 3.4(a)). Notwithstanding anything contained in this Agreement to the contrary, the TN-10 Study constitutes a Phase III Clinical Trial with respect to the Product, Teplizumab.

3.5(b) Qualified Consideration Payment. On May 1, 2023, Seller received a payment in respect of Qualified Consideration in the amount of $5,500,000, pursuant to Qualified Consideration received by Buyer under the Co-Promotion Service Agreement entered into by Buyer and Sanofi S.A. on October 4, 2022. This amount shall be credited against any future milestone payments (other than the Sales-Based Milestone Payment) that may become payable under Section 3.2 or Section 3.4 (other than Section 3.4(a)) in accordance with Section 3.5(a). By way of example, if [***] occurs due to [***], then the applicable $[***] milestone payable pursuant to Section 3.2 shall be reduced to $[***].”

g)The following text is hereby added to the Agreement as a new Section 3.12:

“3.12    Parent Guaranty.

(1)Parent hereby unconditionally, absolutely and irrevocably guarantees, as a primary obligor and not merely as a surety, to Seller the full and punctual payment of the Guaranteed Obligations. Parent agrees to pay the Guaranteed Obligations when and as the same shall become due and payable in accordance with the terms of Section 3.4(a) and upon written notice from Seller. The obligation of Parent pursuant to this Section
3.12 is independent of the obligation of Buyer. Seller shall not be required to pursue legal or equitable remedies or otherwise seek to enforce any contractual provisions under this Agreement against Buyer with respect to the Guaranteed Obligations before seeking enforcement hereunder against Parent.

(2)The liability of Parent hereunder is irrevocable, continuing, absolute, and unconditional and the obligations of Parent hereunder shall not be discharged or impaired or otherwise effected by, and Parent hereby irrevocably waives: (a) any defense based upon any legal disability or other defense of Buyer, any other guarantor or other person, or by reason of the cessation or limitation of the liability of Buyer from any cause other than full payment of all sums payable under this Agreement; (b) any defense based upon


5






any lack of authority of the officers, directors, partners or agents acting or purporting to act on behalf of Buyer or any principal of Buyer; (c) any defense based upon the application by Buyer of the proceeds of this Agreement for purposes other than the purposes represented by Buyer to Seller or intended or understood by Seller or Parent; (d) any and all rights and defenses arising out of an election of remedies by Seller, even though that election of remedies may adversely affect Parent’s rights of subrogation and reimbursement against the principal; (e) any defense based upon any statute or rule of law which provides that the obligation of a surety must be neither larger in amount nor in any other respects more burdensome than that of a principal; (f) any defense based upon Seller’s election, in any proceeding instituted under the U.S. Bankruptcy Code, of the application of Section 1111(b)(2) of the U.S. Bankruptcy Code or any successor statute;
(g) any right of subrogation, any right to enforce any remedy which Seller may have against Buyer and any right to participate in, or benefit from, any security for this Agreement now or hereafter held by Seller; (h) presentment, demand, protest and notice of any kind; (i) the benefit of any statute of limitations affecting the liability of Parent hereunder or the enforcement hereof; and (j) any other circumstance (including without limitation any statute of limitations) whatsoever which might, but for the provisions of this clause, constitute a legal or equitable discharge of Parent’s obligations hereunder (except that Parent may assert the defense of payment in full of the Guaranteed Obligations). Finally, Parent agrees that the performance of any act or any payment which tolls any statute of limitations applicable to this Agreement shall similarly operate to toll the statute of limitations applicable to Parent’s liability hereunder.”

3.Exhibit 2A. A copy of Exhibit 2A to the Agreement is attached hereto as Exhibit A.

4.Entire Agreement. The Agreement (including Amendment No. 1), as supplemented and modified by this Amendment No. 2, together with the exhibits thereto and together with the Side Letter Agreement contains the entire understanding of the Parties with respect to the subject matter hereof and supersedes all prior agreements and understandings, oral or written, with respect to such matters, which the Parties acknowledge have been merged into the Agreement.

5.Governing Law. This Amendment No. 2 shall be governed by and construed under the laws of the State of Delaware, without giving effect to any choice of law principles that would require the application of the laws of a different state.

6.Execution in Counterparts. This Amendment No. 2 may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. This Amendment No. 2 may be executed by .pdf or other electronically transmitted signatures and such signatures shall be deemed to bind each Party as if they were the original signatures.

7.Remaining Provisions of the Agreement. Except as expressly provided herein, each of the other provisions of the Agreement shall remain in full force and effect.

8.References. Upon the effectiveness of this Amendment No. 2, on and after the date hereof, each reference in the Agreement to “this Agreement,” “hereunder,” “hereof,”


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“herein” or words of like import shall mean and be a reference to the Agreement, as amended hereby.

[signature page follows]


7






IN WITNESS WHEREOF, the Parties hereto have caused this Amendment No. 2 to the Asset Purchase Agreement to be duly executed by their respective authorized signatories effective as of the Amendment No. 2 Effective Date.

PROVENTION BIO, INC.    MACROGENICS, INC.


Name: