Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following Management’s Discussion and Analysis of Financial Condition and Results of Operations (this MD&A) together with the consolidated financial statements and the related notes thereto included in this Annual Report on Form 10-K. This MD&A contains forward-looking statements that are subject to risks and uncertainties, such as those set forth in the sections of this Annual Report on Form 10-K captioned “Cautionary Note Regarding Forward-Looking Statements,” “Risk Factors” and elsewhere. As a result, our actual results may differ materially from those anticipated in these forward-looking statements.
Overview
We are a clinical-stage, research and development biotechnology company focused on developing novel immunotherapy candidates for the treatment of different forms of cancer. We have developed two versatile and enabling platform technologies for rational design of precision immune modulatory drugs and have two clinical candidates and three preclinical candidates currently in development. Clinical candidate APVO436 is a CD3xCD123 T-cell engager currently being clinically evaluated for the treatment of acute myelogenous leukemia (AML). Clinical candidate ALG.APV-527 targets 4-1BB (co-stimulatory receptor) and 5T4 (tumor antigen). The compound is designed to reactivate antigen-primed T-cells to specifically kill tumor cells and is currently being evaluated for the treatment of multiple solid tumor types.
Preclinical candidates, APVO603 and APVO711, were also developed using our ADAPTIRTM modular protein technology platform. Our preclinical candidate APVO442 was developed using our ADAPTIR-FLEXTM modular protein technology platform.
Our ADAPTIR and ADAPTIR-FLEX platforms are designed to generate monospecific, bispecific, and multi-specific antibody candidates capable of enhancing the human immune system against cancer cells. ADAPTIR and ADAPTIR-FLEX are both modular platforms, which gives us the flexibility to potentially generate immunotherapeutic candidates with a variety of mechanisms of action. This flexibility in design allows us to generate novel therapeutic candidates that may provide effective strategies against difficult to treat, as well as advanced forms of cancer. We have successfully designed and constructed numerous investigational-stage product candidates based on our ADAPTIR platform. The ADAPTIR platform technology is designed to generate monospecific and bispecific immunotherapeutic proteins that specifically bind to one or more targets, for example, bispecific therapeutic molecules, which may have structural and functional advantages over monoclonal antibodies. The structural differences of ADAPTIR molecules over monoclonal antibodies allow for the development of ADAPTIR immunotherapies that are designed to engage immune effector cells and disease targets to produce signaling responses that modulate the immune system to kill tumor cells.
We believe we are skilled at candidate generation, validation, and subsequent preclinical and clinical development using the ADAPTIR platform and the ADAPTIR-FLEX platform to generate bispecific and multi-specific candidates or other candidates to our platform capabilities. We have developed a preclinical candidate based on the ADAPTIR-FLEX platform which is advancing in our pipeline. We are developing our ADAPTIR and ADAPTIR-FLEX molecules using our protein engineering, preclinical development, process development, and clinical development capabilities.
Results of Operations
Except as otherwise stated below, the following discussions of our results of operations reflect the results of our continuing operations, excluding the results related to Aptevo BioTherapeutics LLC (Aptevo BioTherapeutics), which was sold in February 2020 to Medexus and has been separated from continuing operations and reflected as a discontinued operation. See Note 2 – Discontinued Operations to the accompanying consolidated financial statements for additional information.
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Year Ended December 31, 2023 Compared to Year Ended December 31, 2022
For the year ended December 31, 2023, we had net loss of $17.4 million compared to $8 million net income for the same period in 2022. As of December 31, 2023, we had $16.9 million in cash and cash equivalents.
Royalty Revenue
For the year ended December 31, 2023, we did not record royalty revenue compared to $3.1 million royalty revenue for the same period in 2022. We did not recognize royalty revenue in 2023 due to our Amendment to Royalty Purchase Agreement with HCR. As a result of the amendment, we ceased reporting as royalty revenue, and royalties were paid by Pfizer to HCR related to Pfizer’s sales of RUXIENCE beginning in the second quarter of 2022. The royalty revenue from Pfizer related to a Collaboration and License Agreement ("Definitive Agreement") acquired by Aptevo as part of our spin-off from Emergent in 2016. The Definitive Agreement was originally executed by Trubion Pharmaceuticals, which was subsequently acquired by Emergent, and Wyeth, a wholly owned subsidiary of Pfizer (see Note 9).
On March 30, 2021, we entered into and closed a Royalty Purchase Agreement with an entity managed by HCR pursuant to which we sold to HCR the right to receive royalty payments made by Pfizer in respect of net sales of RUXIENCE. Under the terms of the Royalty Purchase Agreement, the Company received $35 million at closing and we are eligible to receive additional payments in the aggregate of up to an additional $32.5 million based on the achievement of sales milestones in 2021, 2022 and 2023. We received the 2021 milestone payments in the collective amount of $10 million on March 8, 2022. The proceeds from these milestone payments, net of transaction costs, were recorded as an additional liability related to the sale of royalties on the consolidated balance sheet as of March 31, 2022.
Due to the nature of the transaction, which included a cap on HCR’s rate of return, constituting continuing involvement under the Collaboration and License Agreement originally between Trubion and Wyeth, we recorded a liability related to the proceeds received from HCR of $35.0 million, net of transaction costs of $1.1 million. Further, we received proceeds related to the 2021 milestone of $10.0 million, net of transaction costs of $0.5 million, and recorded additional liability related to sale of royalties. We recognized royalty revenue on net sales of RUXIENCE and recorded the royalty payments to HCR as a reduction of the liability when paid.
In order to non-dilutively address a Nasdaq listing compliance matter, on June 7, 2022, we entered into and closed an amendment to the Royalty Purchase Agreement (the Amendment to Royalty Purchase Agreement), pursuant to which we agreed to forego our right to receive 50% of incremental RUXIENCE royalty revenue after HCR received aggregate royalty payments totaling 190% of the Investment Amount plus Milestone Amounts to the extent paid by HCR. The Amendment to Royalty Purchase Agreement eliminated all of our continuing involvement with the cash generating activities related to the royalties and removed all restrictions related to HCR’s rate of return and therefore was accounted for under ASC 610-20, Gains and Losses from Derecognition of Nonfinancial Assets and ASC 405-20, Liabilities – Extinguishment of Liabilities, resulting in recognition of $37.2 million gain, which was the total balance of the liability related to the sale of royalties on the closing date.
We received 2022 milestone payment of $2.5 million on February 28, 2023. The proceeds from the 2022 milestone payment were recorded as other income in the consolidated statement of operations for the year ended December 31, 2022. We do not expect to receive any further milestone payments pursuant to our royalty purchase agreement.
Research and Development Expenses
We expense research and development costs as incurred. These expenses relate primarily to conducting non-clinical studies and clinical trials, fees to professional service providers for analytical testing, independent monitoring or other administration of our clinical trials and obtaining and evaluating data from our clinical trials and non-clinical studies. Our research and development expenses include:
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employee salaries and related expenses, including stock-based compensation and benefits for our employees involved in our drug discovery and development activities;
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consulting costs related to our clinical and preclinical programs;
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external research and development expense incurred under agreements with third-party contract research organizations (CROs) and investigative sites;
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manufacturing services and material expense for third-party manufacturing; and
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overhead costs such as rent, utilities and depreciation.
We expect our research and development spending will be dependent upon such factors as the results from our clinical trials, the availability of reimbursement of research and development spending, the number of product candidates under development, the size, structure and duration of any clinical programs that we may initiate, and the costs associated with manufacturing our product candidates on a large-scale basis for later stage clinical trials. We may experience interruption of key clinical trial activities, such as site initiation, patient enrollment and clinical trial site monitoring, and key non-clinical activities due to a variety of risk factors, including macroeconomic conditions. While a number of our programs are still in the preclinical trial phase, we do not provide a breakdown of the initial associated expenses as we are often evaluating multiple product candidates simultaneously. Costs are reported in preclinical research and discovery until the program enters the clinic.
Our research and development expenses by program for the years ended December 31, 2023 and 2022 are shown in the following table:
For the Year Ended December 31,
(in thousands) 2023 2022 Increase (Decrease)
Clinical programs:
Preclinical program, general research and discovery 9,021 11,452 (2,431 )
Research and development expenses decreased by $0.8 million, to $17.1 million for the year ended December 31, 2023 from $17.9 million for the year ended December 31, 2022. The decrease was primarily due to lower APVO436 trial costs as we concluded our Phase 1b dose expansion study. The decrease was partially offset by higher expenses related to ALG.APV-527 trial costs as 2023 consisted of a full year of CRO and patient visit costs compared to preclinical and start-up activities in 2022.
General and Administrative Expenses
General and administrative expenses consist primarily of personnel-related costs and professional fees in support of our executive, business development, finance, accounting, information technology, legal and human resource functions. Other costs include facility costs not otherwise included in research and development expenses.
For the year ended December 31, 2023, general and administrative expenses decreased by $2.1 million, to $11.8 million from $13.9 million for the year ended December 31, 2022. The decrease is primarily due to lower employee and consulting costs.
Other Income (Expense), Net
Other income (expense), net consists primarily of gain on extinguishment of liabilities, milestone income related to sale of royalties, costs related to debt extinguishment, accrued exit fees on debt, non-cash interest on financing agreements, and interest on debt.
Other Income (Expense), Net
Other income, net was $0.6 million for the year ended December 31, 2023 and other expense, net was $4.0 million for the year ended December 31, 2022. The change in other income (expense), net is primarily due to higher interest income from our money market funds and not having interest expense related to our MidCap term loan due to principal paydown and full repayment of the outstanding balance in the first quarter of 2023. Additionally, we no
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longer record non-cash interest expense due to our Amendment to the Royalty Purchase Agreement in the second quarter of 2022, which eliminated the liability related to the sale of royalties and the related non-cash interest expense.
Gain Related to Sale of Nonfinancial Asset
We recorded $9.7 million in other income for the year ended December 31, 2023, due to the sale of deferred payments and milestones to XOMA during the year (see Note 3).
Gain on Extinguishment of Liability Related to Sale of Royalties
We recorded $37.2 million in other income for the year ended December 31, 2022, due to our Amendment to Royalty Purchase Agreement (see Note 9).
Milestone Income Related to the Sale of Royalties
We recorded $2.5 million in other income for the year ended December 31, 2022, related to Pfizer's net sales of RUXIENCE in fiscal year 2022. Due to our Amendment to Royalty Purchase Agreement, we record Milestone Amounts from HCR when they are earned (see Note 9).
Discontinued Operations
For the year ended December 31, 2023 and 2022, we recorded $1.2 million and $1.0 million, respectively, of contingent gain consideration from previous discontinued operations.
Liquidity and Capital Resources
Cash Flows
The following table provides information regarding our cash flows for year ended December 31, 2023 and 2022:
For the Year Ended December 31,
Net cash (used in) provided by:
Investing activities — (29 )
(Decrease) in cash and cash equivalents $ (5,732 ) $ (23,667 )
Net cash used in operating activities for the year ended December 31, 2023, was primarily due to our net operating loss of $17.4 million and changes in our working capital accounts, and was partially offset by $2.5 million HCR 2022 royalty milestone payment. Net cash used in operating activities for the year ended December 31, 2022, was primarily due to changes in working capital accounts and our operating cash spend.
Net cash used in investing activities for the year ended December 31, 2023 was $0. Net cash used in investing activities for the year ended December 31, 2022 was primarily due to purchases of property and equipment.
Net cash provided by financing activities for the year ended December 31, 2023 was primarily due to the $3.3 million proceeds received from the issuance of common stock, $3.0 million proceeds received from the exercise of pre-funded warrants, and $3.3 million gross proceeds received from the exercise of common warrants. This was offset by $3.5 million of repayments of the MidCap term loan, which included the remaining outstanding principal balance and loan prepayment fees. Net cash used in financing activities for the year ended December 31, 2022 was primarily due to the $12.3 million of repayments of the MidCap Financial term loan, and $6.8 million royalties received from Pfizer by HCR pursuant to our Royalty Purchase Agreement. This was offset by the $10 million milestone received by Aptevo from HCR related to the sale of royalties, net of $0.5 million transaction costs, and $7.0 million of proceeds received from issuance of common stock pursuant to our Equity Distribution Agreement with Piper Sandler.
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Sources of Liquidity
IXINITY Milestone Payments
On February 28, 2020, Aptevo entered into an LLC Purchase Agreement with Medexus, pursuant to which we sold all of the issued and outstanding limited liability company interests of Aptevo BioTherapeutics LLC, a wholly owned subsidiary of Aptevo. On March 29, 2023, we entered into and closed a Purchase Agreement with XOMA pursuant to which we sold to XOMA our right, title, and interest to all future deferred payments from Medexus and a portion of potential milestones. Aptevo continues to be eligible to receive up to $5.8 million in milestone payments from Medexus upon achievement of certain regulatory and IXINITY net sales threshold. For the year ended December 31, 2023, Aptevo received $0.5 million in deferred payments from Medexus related to IXINITY sales for the fourth quarter of 2022.
Lincoln Park Purchase Agreement
On February 16, 2022, we entered into a new Purchase Agreement and a Registration Rights Agreement with Lincoln Park (2022 Purchase Agreement and Registration Rights Agreement). The 2022 Purchase Agreement and Registration Rights Agreement replaced our Purchase Agreement and Registration Rights Agreement with Lincoln Park that we entered into with them in December 2018. Under the 2022 Purchase Agreement, Lincoln Park committed to purchase up to $35.0 million worth of our common stock over a 36-month period commencing after the satisfaction of certain conditions, which are within our control, as set forth in the Purchase Agreement. The purchase price per share will be based on the prevailing market price; provided, however, that the prevailing market price is not below $1.00. The Company issued 99,276 shares of our common stock to Lincoln Park for no cash consideration as an initial fee for its commitment to purchase shares of our common stock under the Purchase Agreement. The aggregate number of shares that we can sell to Lincoln Park under the Purchase Agreement may not exceed 981,103 shares, unless shareholder approval is obtained or the average price of all applicable sales of our common stock sold to Lincoln Park equals or exceeds $6.14 per share. For the year ended December 31, 2023, we issued 300,000 shares of our common stock for cash consideration to Lincoln Park under the 2022 Purchase Agreement. We received $0.5 million in proceeds from these shares. The Company did not issue any shares of common stock for cash consideration to Lincoln Park under the Purchase Agreement for the year ended December 31, 2022.
Actual sales of shares of our common stock to Lincoln Park under the Purchase Agreement will occur at our discretion from time to time and depend on a variety of factors, including, among others, market conditions, the trading price of our common stock and additional determinations as to the appropriate sources of funding for our operations. Lincoln Park has no right to require any sales, but is obligated to make purchases as we direct, in accordance with the Purchase Agreement.
Common Warrants - 2019
On March 11, 2019, in connection with the completion of a public offering of common stock, we issued warrants to purchase 1,571,429 shares of common stock at a price of $18.20. As of December 31, 2023 and 2022, there were warrants to purchase 350,589 shares of common stock outstanding. These warrants have a 5-year life and expire in March 2024.
Series A and Series B Common Warrants - August 2023
On August 4, 2023, in connection with the completion of a public offering, we issued Series A Common Warrants to purchase up to an aggregate of 8,064,517 shares of common stock and Series B Common Warrants to purchase up to an aggregate of 8,064,517 shares of common stock. The Series A and Series B Common Warrants have an exercise price of $0.62 per share, are exercisable immediately following the date of issuance and will expire on August 4, 2028 and February 4, 2025, respectively. As of December 31, 2023, we have 1,872,516 Series A and 58,000 Series B Common Warrants outstanding from our August 2023 public offering with an exercise price of $0.62 per
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share. If the remaining August 2023 warrants are exercised, we may receive up to an additional $1.1 million in gross proceeds.
New Series A and Series B Common Warrants - November 2023
On November 9, 2023, we entered into a warrant Inducement Agreement with certain holders of our existing Series A common warrants and Series B common warrants (together, the "Existing Warrants") to purchase shares of common stock. Pursuant to the terms of the Inducement Agreement, the holders agreed to exercise for cash their Existing Warrants to purchase up to an aggregate of 16,013,034 shares of common stock at an exercise price of $0.233 during the period from the date of the Inducement Agreement until December 8, 2023. In consideration of the holder’s agreement to exercise the Existing Warrants, we agreed to issue new Series A and new Series B common warrants (together, the "New Warrants"), to purchase a number of shares of common stock equal to 200% of the number of shares of common stock issued upon exercise of the Existing Warrants. Holders exercised 6,192,001 Existing Series A and 8,006,517 Existing Series B Warrants and the Company received $3.3 million in gross proceeds. As of December 31, 2023, we have 12,384,002 New Series A and 16,013,034 New Series B Common Warrants outstanding from our November 2023 warrant inducement with an exercise price of $0.233 per share. If the New Warrants are exercised, we may receive up to an additional $6.6 million in gross proceeds.
Liquidity
We have financed our operations to date primarily through royalty and purchase agreements with various partners, sale of business products and segments, public offerings of our common stock, loan proceeds, milestone payments, research and development funding from strategic partners, revenue generated from our previously owned commercial products, and funds received at the date of our spin-off from Emergent. We had cash and cash equivalents of $16.9 million and an accumulated deficit of $223.4 million as of December 31, 2023.
For the year ended December 31, 2023, net cash used in our operating activities was $11.7 million.
Our future success is dependent on our ability to develop our product candidates. We anticipate that we will continue to incur significant operating losses for the next several years as we incur expenses to continue to execute on our development strategy to advance our preclinical and clinical stage assets. We will not generate revenues from our development stage product candidates unless and/or until we or our collaborators successfully complete development and obtain regulatory approval for such product candidates, which we expect will take a number of years and is subject to significant uncertainty. If we obtain regulatory approval for one of our development stage product candidates, we expect to incur significant commercialization expenses related to sales, marketing, manufacturing and distribution, to the extent that such costs are not paid by collaborators. We do not have sufficient cash to complete the clinical development of any of our development stage product candidates and will require additional funding in order to complete the development activities required for regulatory approval of such product candidates. We will require substantial additional funds to continue our development programs and to fulfill our planned operating goals.
We may experience delays in opportunities to partner our product candidates, due to financial and other impacts on potential partners. Additionally, we may experience potential impacts on our future milestones from Medexus due to effects of macroeconomic impacts, including, but not limited to, bank failure, and the rising and fluctuating inflation, which may impact Medexus’ ability to continue to successfully commercialize the IXINITY businesses.
There are numerous risks and uncertainties associated with research, development, and commercialization of pharmaceutical products. Accordingly, our future funding requirements may vary from our current expectations and will depend on many factors, including, but not limited to:
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our ability to raise additional capital when needed or on acceptable terms;
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future profitability given our historical losses;
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our ability to attract, motivate and retain key personnel;
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the timing of, and the costs involved in, completing our clinical trials, and obtaining regulatory approvals for our product candidates;
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our ability to obtain regulatory clearance to commence clinical trials for product candidates;
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our ability to establish and maintain strategic partnerships, licensing or other arrangements and the financial terms of such agreements;
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the effects of macroeconomic conditions, including rising and fluctuating inflation, interest rates and supply chain constraints;
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our ability to successfully develop our ADAPTIR or ADAPTIR-FLEX platforms;
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the results of our current and planned preclinical studies and clinical trials;
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the scope, progress, results, and costs of researching and developing our product candidates, and of conducting preclinical and clinical trials, including whether clinical trial results will be consistent with the past data;
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our reliance on third parties to effectively conduct our clinical and non-clinical trials, and to effectively carry out their contractual duties, comply with regulatory requirements or meet expected deadlines;
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the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims, including litigation costs and the outcome of such litigation;
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the cost of commercialization activities if any of our product candidates are approved for sale, including marketing, sales, and distribution costs;
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the timing, receipt and amount of any milestone payments and deferred payments from Medexus with respect to IXINITY; and
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our ability to continue as a going concern.
If we are unable to raise substantial additional capital in the next year, whether on terms that are acceptable to us or at all, then we may be required to:
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delay, limit, reduce or terminate our clinical trials or other development activities for one or more of our product candidates; and/or,
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delay, limit, reduce or terminate our establishment of other activities that may be necessary to commercialize our product candidates, if approved.
The sale of additional equity or convertible debt securities may result in additional dilution to our stockholders. If we raise additional funds through the issuance of debt securities or preferred stock or through credit facilities, these securities and/or the loans under credit facilities could provide for rights senior to those of our common stock and could contain covenants that would restrict our operations. Additional funds may not be available when we need them, on terms that are acceptable to us, or at all. We also expect to seek additional funds through arrangements with collaborators, licensees or other third parties. These arrangements would generally require us to relinquish or encumber rights to some of our technologies or drug candidates, and we may not be able to enter into such arrangements on acceptable terms, if at all. Due to the macroeconomic factors, we may experience delays in clinical trials and non-clinical work, and opportunities to partner our product candidates, due to financial and other impacts on potential partners.
Our results of operations will be highly dependent on our research and development spending. When considered in aggregate, these factors raise substantial doubt about our ability to continue as a going concern for the one-year period from the date of issuance of these financial statements. We will need to raise additional funds to support our operating and capital needs in addition to our existing cash resources, cash to be generated from future milestones related to IXINITY sales and regulatory approvals achieved by Medexus, and exercise of warrants.
Our plans to address this condition include pursuing one or more of the following options to secure additional funding, none of which can be guaranteed or are entirely within our control:
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raise funding through the possible additional sales of our common stock through public or private equity financings;
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license, partner, or sell a portion or all rights to any of our assets to secure potential additional non-dilutive funds; and
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establish additional credit lines or other debt financing sources.
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There can be no assurance, however, that we will receive cash proceeds from any of these potential resources or to the extent cash proceeds are received such proceeds would be sufficient to support our current operating plan for at least the next twelve months from the date of filing this Annual Report on Form 10-K.
Contractual Obligations
We have an operating lease related to our office and laboratory space in Seattle, Washington. This lease was amended in March 2019 to extend the term of the amended lease is through April 2030 and provided two options to extend the lease term, each by five years, as well as a one-time option to terminate the lease in April 2023, with nine months’ notice, or by July 2022. On May 26, 2022, we further amended our office and laboratory lease to remove the one-time termination option in April 2023. In exchange for removing the termination option, we received six months of free rent. As a result, we recorded an additional $4.4 million of lease liability and right-of-use asset on the consolidated balance sheet in May 2022.
We have a non-exclusive Commercial Platform License Agreement with OMT ("OMT License Agreement") for certain transgenic rodents of OMT's OmniAb platform. Our OMT License Agreement obligates us to make milestone and royalty payments upon achievement of certain regulatory approvals and commercialization of our product candidates. APVO436 and APVO603 are the product candidates currently subject to this agreement. Pursuant to our agreement, we are required to make a $2.0 million milestone payment upon dosing the first patient in our Phase 2 clinical trial of APVO436.
Our principal commitments include obligations under vendor contracts to purchase research services and other purchase commitments with our vendors. In the normal course of business, we enter into services agreements with contract research organizations, contract manufacturing organizations and other third parties. Generally, these agreements provide for termination upon notice, with specified amounts due upon termination based on the timing of termination and the terms of the agreement. The actual amounts and timing of payments under these agreements are uncertain and contingent upon the initiation and completion of the services to be provided.
Critical Accounting Policies, and Significant Judgments, and Estimates
The preparation of our consolidated financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. We base our estimates on historical experience and on various other factors. Although we believe that our judgments and estimates are appropriate, actual results may differ materially from our estimates and changes in these estimates are recorded when known. An accounting policy is considered critical if it is important to a company’s financial condition and results of operations and if it requires the exercise of significant judgment and the use of estimates on the part of management in its application.
While our significant accounting policies are more fully described in Note 1 to our audited consolidated financial statements appearing elsewhere in this report, we believe the following accounting policies are the most critical to the judgments and estimates we use in the preparation of our consolidated financial statements.
Research and Development Expenses
Research and development expenses are expensed as incurred. Research and development costs primarily consist of internal labor costs, fees paid to outside service providers and the costs of materials used in clinical trials and research and development. Other research and development expenses include facility, maintenance, and related support expenses.
A substantial portion of our preclinical studies and all of our clinical studies have been performed by third-party contract research organizations (CRO). We review the activities performed by the CROs each period. For preclinical studies, the significant factors used in estimating accruals include the percentage of work completed to date and contract milestones achieved. For clinical study expenses, the significant factors used in estimating accruals include the number of enrolled patients visit at each site to date. Our estimates are highly dependent upon the timeliness and accuracy of the data provided by our CROs regarding the status of each program and total program spending and adjustments are made when deemed necessary.
Stock-Based Compensation
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Under ASC 718, Compensation—Stock-based Compensation, we measure and recognize compensation expense for restricted stock units (RSUs), and stock options granted to our employees and directors based as of the fair value of the awards on the date of grant. The fair value of stock options is estimated at the date of grant using the Black-Scholes option pricing model that requires management to apply judgment and make estimates, including:
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the expected term of the stock option award, which we calculate using the simplified method, as permitted by the SEC Staff Accounting Bulletin No. 110, Share-Based Payment, as we have insufficient historical information regarding our stock options to provide a basis for an estimate;
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the expected volatility of our underlying common stock, which we estimate based on the historical volatility of a representative group of publicly traded biopharmaceutical companies with similar characteristics to us, and our own historical and implied future volatility;
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the risk-free interest rate, which we based on the yield curve of U.S. Treasury securities with periods commensurate with the expected term of the options being valued;
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the expected dividend yield, which we estimate to be zero based on the fact that we have never paid cash dividends and have no present intention to pay cash dividends; and
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the fair value of our common stock on the date of grant.
Stock-based compensation expense for RSUs, and stock options is recognized on a straight-line basis over the requisite service period, which is generally the vesting period of the respective award. We are required to estimate a forfeiture rate to calculate the stock-based compensation expense for our awards. Our forfeiture rate is based on an analysis of our actual forfeitures since the adoption of our equity award plan. We routinely evaluate the appropriateness of the forfeiture rate based on actual forfeiture experience, analysis of employee turnover, and expectations of future option exercise behavior.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk.
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act, and are not required to provide the information required under this item.
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Table of Contents
Index to Consolidated Financial Statements
Item 8. Financial Statements and Supplementary Data
APTEVO THERAPEUTICS INC.
Financial Statements
Consolidated Balance Sheets 75
Consolidated Statements of Operations 76
Consolidated Statements of Cash Flows 77
Consolidated Statements of Changes in Stockholders’ Equity 78
Notes to Consolidated Financial Statements 79
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Report of Independent Registered Public Accounting Firm
To the Stockholders and the Board of Directors of
Aptevo Therapeutics Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Aptevo Therapeutics Inc. (the “Company”) as of December 31, 2023 and 2022, the related consolidated statements of operations, cash flows, and changes in stockholders’ equity for the years then ended, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the consolidated financial position of the Company as of December 31, 2023 and 2022, and the consolidated results of its operations and its cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States of America.
Going Concern Uncertainty
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the consolidated financial statements, the Company has suffered recurring losses from operations and has a net capital deficiency that raise substantial doubt about its ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 1. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidatedfinancial statements, whether due to error or fraud, and performing procedures to respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidatedfinancial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits providea reasonable basis for our opinion.
Critical Audit Matter
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The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that (1) relates to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Accounting for the Sale of Future Payments for IXINITY Sales
As described in Note 3, the Company sold to XOMA the right to receive all deferred payments and a portion of milestone payments related to global sales of IXINITY in exchange for total cash consideration of $9.65 million. The sale of deferred payments and certain milestone payments was recorded as a gain related to the sale of a non-financial asset in the Company’s consolidated statements of operations for the year ended December 31, 2023.
We identified the accounting for the sale of future payments for IXINITY sales as a critical audit matter because the transaction was highly complex and required management to interpret and apply complex accounting standards. This, in turn, led to a high degree of auditor judgment and increased audit effort, including the use of subject matter experts on technical accounting matters, in performing procedures to evaluate whether the transaction was properly accounted for in accordance with relevant accounting principles.
The primary procedures we performed to address this critical audit matter included:
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Reviewing the analysis prepared by management and the related agreements to obtain an understanding of the sale of future payments for IXINITY sales.
•
With the assistance of a subject matter expert on technical accounting matters, evaluating the reasonableness of management’s accounting conclusion to record the sale of future payments for IXINITY sales as a gain related to the sale of a non-financial asset.
•
Evaluating management's analysis by:
o
testing the completeness and accuracy of inputs by comparing key terms to the relevant agreements,
o
agreeing the dollar value of the gain recorded as other income to the agreement,
o
recalculating the total purchase price, and
o
agreeing cash payments received to bank statements.
/s/ Moss Adams LLP
Seattle, Washington
March 5, 2024
We have served as the Company’s auditor since 2020.
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Aptevo Therapeutics Inc.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share amounts)
ASSETS
Current assets:
Royalty and milestone receivable — 2,500
Property and equipment, net 895 1,462
Operating lease right-of-use asset 4,881 5,303
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and other accrued liabilities $ 3,984 $ 3,499
Current portion of long-term debt — 2,000
Long-term debt — 1,456
Stockholders' equity:
Total liabilities and stockholders' equity $ 24,842 $ 34,215
The accompanying notes are an integral part of these consolidated financial statements.
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Aptevo Therapeutics Inc.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
For the Year Ended December 31,
Royalty revenue $ — $ 3,114
Operating expenses:
Other income (expense):
Other income (expense) from continuing operations, net 578 (4,027 )
Gain related to sale of non-financial asset 9,650 —
Gain on extinguishment of liability related to sale of royalties — 37,182
Milestone income related to sale of royalties — 2,500
Net (loss) income from continuing operations (18,650 ) 7,014
Discontinued operations:
Income from discontinued operations 1,239 1,013
Net (loss) income per share:
Shares used in calculation:
The accompanying notes are an integral part of these consolidated financial statements.
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Aptevo Therapeutics Inc.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
For the Year Ended December 31,
Operating Activities
Adjustments to reconcile (loss) income to net cash used in operating activities:
Depreciation and amortization 567 901
Loss on disposal of property and equipment — 47
Non-cash interest expense and other 10 3,239
Gain on extinguishment of liability related to sale of royalties — (37,182 )
Changes in operating assets and liabilities:
Prepaid expenses and other current assets 153 355
Operating lease right-of-use asset 422 653
Accounts payable, accrued compensation and other liabilities 518 (394 )
Long-term operating lease liability (682 ) 366
Net cash used in operating activities (11,730 ) (21,022 )
Investing Activities
Purchases of property and equipment — (29 )
Net cash used in investing activities — (29 )
Financing Activities
Payments of long-term debt, including fees (3,467 ) (12,267 )
Repayments under liability related to sale of royalties — (6,779 )
Value of equity awards withheld for tax liability (10 ) (4 )
Proceeds from exercises of warrants 3,047 —
Proceeds from milestones related to sale of royalties — 10,000
Transaction costs for milestones related to sale of royalties — (500 )
Proceeds from issuance of common stock and prefunded warrants 6,428 6,934
Net cash provided by (used in) financing activities 5,998 (2,616 )
(Decrease) in cash and cash equivalents (5,732 ) (23,667 )
Cash and cash equivalents at beginning of period 22,636 46,303
Cash and cash equivalents at end of period $ 16,904 $ 22,636
Supplemental Cash Flow Information
Warrant modification - incremental value $ 2,080 $ —
The accompanying notes are an integral part of these consolidated financial statements.
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Aptevo Therapeutics Inc.
CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY
(in thousands, except share amounts)
Additional Total
Common Stock Paid-In Accumulated Stockholders'
Shares Amount Capital Deficit Equity
Stock-based compensation — — 1,802 — 1,802
Net income for the period — — — 8,027 8,027
Proceeds from warrant inducement, net of issuance cost(1) 3,809,652 4 963 — 967
Warrant modification - incremental fair value — — 2,080 — 2,080
Stock-based compensation — — 2,193 — 2,193
Net (loss) for the period — — — (17,411 ) (17,411 )
(1) Includes gross proceeds of $3.3 million less issuance costs of $2.3 million, which includes $2.1 million warrant modification incremental fair value.
The accompanying notes are an integral part of these consolidated financial statements.
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Aptevo Therapeutics Inc.
Notes to Consolidated Financial Statements
Note 1. Nature of Business and Significant Accounting Policies
Organization and Liquidity
Aptevo Therapeutics Inc. (Aptevo, we, us, or the Company) is a clinical-stage, research and development biotechnology company focused on developing novel immunotherapy candidates for the treatment of different forms of cancer. We have developed two versatile and enabling platform technologies for rational design of precision immune modulatory drugs. Our clinical candidates, APVO436 and ALG.APV-527, and preclinical candidates, APVO603 and APVO711, were developed using our ADAPTIRTM modular protein technology platform. Our preclinical candidate APVO442 was developed using our ADAPTIR-FLEXTM modular protein technology platform.
We are currently trading on the Nasdaq Capital Market under the symbol “APVO.”
The accompanying consolidated financial statements have been prepared on a basis that assumes we will continue as a going concern and which contemplates the realization of assets, and satisfaction of liabilities, and commitments in the normal course of business. For the year ended December 31, 2023, we had net loss of $17.4 million. We had an accumulated deficit of $223.4 million as of December 31, 2023. For the year ended December 31, 2023, net cash used in our operating activities was $11.7 million. We have suffered recurring losses from operations and negative cash flows from operating activities. When considered in aggregate, these factors raise substantial doubt about our ability to continue as a going concern for the one-year period from the date of issuance of these financial statements. We will need to raise additional funds to support our operating and capital needs in addition to our existing cash resources, cash to be generated from future milestones related to IXINITY sales and regulatory approvals achieved by Medexus Pharmaceuticals ("Medexus"), and exercise of warrants. We may choose to raise additional funds to support our operating and capital needs in the future.
We continue to face significant challenges and uncertainties and, as a result, our available capital resources may be consumed more rapidly than currently expected due to: (a) changes we may make to the business that affect ongoing operating expenses; (b) changes we may make in our business strategy; (c) changes we may make in our research and development spending plans; (d) whether and to what extent expected milestones are received from Medexus with respect to IXINITY; (e) whether and to what extent future milestone payments are received under our Royalty Purchase Agreement; (f) macroeconomic conditions such as rising interest rates, inflation and costs; and (g) other items affecting our forecasted level of expenditures and use of cash resources. We may obtain additional funding through our existing equity Purchase Agreement with Lincoln Park or attempt to obtain other public or private financing, collaborative or licensing arrangements with strategic partners, or through credit lines or other debt financing sources to increase the funds available to fund operations. However, we may not be able to secure such funding in a timely manner or on favorable terms, if at all. Furthermore, if we issue equity or debt securities to raise additional funds, our existing stockholders may experience dilution, and the new equity or debt securities may have rights, preferences, and privileges senior to those of our existing stockholders. If we raise additional funds through collaboration, licensing, or other similar arrangements, it may be necessary to relinquish valuable rights to our potential products or proprietary technologies, or grant licenses on terms that are not favorable to us. Without additional funds, we may be forced to delay, scale back, or eliminate some of our research and development activities or other operations and potentially delay product development in an effort to provide sufficient funds to continue our operations. If any of these events occurs, our ability to achieve our development goals may be adversely affected. Given the continuing global economic and geopolitical climate, including rising interest rates and stock market volatility, we may experience delays or difficulties in the financing environment and raising capital due to economic uncertainty.
Basis of Presentation
The accompanying consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP). These consolidated financial statements include all adjustments, which include normal recurring adjustments, necessary for the fair presentation of the Company’s financial position.
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from these estimates and changes in these estimates are recorded when known.
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The consolidated financial statements include the accounts of the Company and our wholly owned subsidiary, Aptevo Research and Development LLC. All intercompany balances and transactions have been eliminated. All intercompany balances and transactions have been eliminated.
Significant Accounting Policies
Use of Estimates
The preparation of financial statements in conformity with GAAP requires estimates and assumptions that affect the reported amounts of assets and liabilities, revenues and expenses, and related disclosures of contingent liabilities in the consolidated financial statements and accompanying notes. Estimates are used for, but not limited to, clinical accruals, useful lives of equipment, commitments and contingencies, stock-based compensation, and incremental borrowing rate (IBR) used for our lease. Given the global economic and geopolitical climate, these estimates are becoming more challenging, and actual results could differ materially from those estimates.
Cash Equivalents
Cash equivalents are highly liquid investments with a maturity of 90 days or less at the date of purchase and include time deposits and investments in money market funds with commercial banks and financial institutions.
Concentrations of Credit Risk
Financial instruments that potentially subject Aptevo to concentrations of credit risk consist primarily of cash and cash equivalents, certain investments and royalty and milestone receivable. Aptevo places its cash and cash equivalents with high quality financial institutions and may maintain cash balances in excess of insured limits. Management believes that the financial risks associated with its cash and cash equivalents are minimal.
Property and Equipment
Property and equipment are stated at cost. Depreciation is computed using the straight-line method over the following estimated useful lives:
Furniture and equipment 7-10 years
Software and hardware 3-5 years or product life
Leasehold improvements Lesser of the asset life or the remaining lease term
Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is credited or charged to operations. Repairs and maintenance costs are expensed as incurred.
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Leases
We determine if an arrangement is a lease at inception date. Leases are to be classified as finance or operating leases at the lease commencement date, which affects the classification of expense recognition in the consolidated statement of operations. Right-of-use assets represent the right to use an underlying asset for the lease term and lease liabilities represent the obligation to make lease payments, as agreed to in the lease. Operating lease liabilities and the corresponding right-of-use assets are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. An operating right-of-use asset is measured as the amount of the initial measurement of the lease liability, adjusted for prepaid or accrued lease payments, the remaining balance of any lease incentive received, unamortized initial direct costs, and any impairment of the right-of-use asset. The initial measurement of the lease liabilities and right-to-use assets of finance leases is the same as for operating leases. We include options to extend the lease and certain termination options in our lease liability and right-of-use asset when it is reasonably certain that we will exercise those options.
As our existing leases do not contain an implicit interest rate, we estimate our IBR based on information available at commencement date in determining the present value of future payments. Due to the significant judgment involved and the complex analysis needed to determine this discount rate, we engaged a third-party valuation specialist to advise us in our determination of our IBR for the initial adoption of the standard and subsequent amendment of our office lease.
Lease expense for operating leases is recognized on a straight-line basis over the lease term as part of our selling, general and administrative expenses and our research and development expenses on our consolidated statements of operations. Lease expense for financing leases consists of amortization of the right-of-use asset and interest on the lease liability as part of our research and development expenses on our consolidated statements of operations.
Fair Value of Financial Instruments
We measure and record cash equivalents at fair value in the accompanying financial statements. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability, an exit price, in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs.
The carrying amounts of our short-term financial instruments, which include cash and cash equivalents, royalty and milestone receivable and accounts payable, approximate their fair value due to their short maturities.
Debt Extinguishment
On March 29, 2023, we used a portion of the proceeds from our Purchase Agreement with XOMA to fully repay the $2.8 million outstanding principal balance of our MidCap debt, and $0.3 million in exit fees. The pre-payment was not considered an amendment to our Credit Agreement (as defined below) since we were required to fully repay the remaining principal balance if we sold our IXINITY deferred payment stream and milestones.
Royalty Revenue
We recognized revenue in accordance with ASC 606 - Revenue from Contracts with Customers. Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation.
RUXIENCE Royalty Revenue
Aptevo’s royalty revenue was exclusively related to royalties on Pfizer’s net sales of RUXIENCE. We did not recognize royalty revenue for the year ended December 31, 2023. Royalty revenue for the period covered by this report reflects revenue recorded only in the first quarter of 2022 due to our Amendment to Royalty Purchase Agreement with HCR (see Note 9). As a result of the Amendment to Royalty Purchase Agreement, we ceased reporting as royalty revenue, royalties paid by Pfizer to HCR related to Pfizer’s sales of RUXIENCE.
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We recognized royalty revenue under ASC 606, which provides revenue recognition constraints by requiring the recognition of revenue at the later of the following: (1) when the subsequent sale or usage occurs or (2) when the performance obligation to which some or all of the sales-based or usage-based royalty has been allocated has been satisfied (or partially satisfied). We satisfied our performance obligation prior to the period covered by this report, specifically in May 2011 when the original Collaboration and License Agreement between Trubion Pharmaceuticals and Wyeth was amended to remove the exclusivity/non-compete restrictions so that Pfizer could develop a CD20 biosimilar product in exchange for a one-time payment of $2.5 million and future royalties of 2.5% on any CD20 biosimilar product commercialized by Pfizer in the future. We do not have future performance obligations under this agreement. We applied the royalty recognition constraint required under the guidance for sales-based royalties, which requires a sales-based royalty to be recorded no sooner than the underlying sale. Therefore, royalties on sales of products commercialized by Pfizer were recognized in the quarter the product is sold.
Given the royalty revenues were based on 2.5% of global net sales of RUXIENCE, the considerations were considered variable. Pfizer generally reported sales information to us within 60 days of quarter end. Unless we received finalized sales information for the respective quarter, we estimated the expected royalty proceeds based on an analysis of historical experience, analyst expectations, interim data provided by Pfizer, including their publicly announced sales, and other publicly available information. Differences between actual and estimated royalty revenues were adjusted for in the period in which they became known, typically the following quarter. Aptevo did not record revenue for the year ended December 31, 2023 due to our Amendment to Royalty Purchase Agreement. Revenue recorded for the year ended December 31, 2022 represents actual royalty revenue given the timing of RUXIENCE sales reports received from Pfizer. There was no significant financing component to the contract.
Research and Development Expenses
Research and development expenses are expensed as incurred. Research and development costs primarily consist of internal labor costs, fees paid to outside service providers and the costs of materials used in clinical trials and research and development. Other research and development expenses include facility, maintenance, and related support expenses.
A substantial portion of Aptevo’s preclinical studies and all of its clinical studies have been performed by third-party CROs. The Company reviews the activities performed by the CROs each period. For preclinical studies, the significant factors used in estimating accruals include the percentage of work completed to date and contract milestones achieved. For clinical study expenses, the significant factors used in estimating accruals include the number of patients enrolled and services provided but not yet invoiced. The Company’s estimates are highly dependent upon the timeliness and accuracy of the data provided by its CROs regarding the status of each program and total program spending and adjustments are made when deemed necessary.
General and Administrative Expenses
General and administrative expenses consist primarily of personnel-related costs and professional fees in support of our executive, business development, finance, accounting, information technology, legal and human resource functions. Other costs include facility costs not otherwise included in research and development expense.
Stock-Based Compensation
We measure and recognize compensation expense for restricted stock units (RSUs), and stock options granted to our employees and directors based on the fair value of the awards as of the date of grant. The fair value of stock options is estimated at the date of grant using the Black-Scholes option pricing model that requires management to apply judgment and make estimates, including:
•
the expected term of the stock option award, which we calculate using the simplified method, as we have insufficient historical information regarding our stock options to provide a basis for an estimate;
•
the expected volatility of our underlying common stock, which we estimate based on the historical volatility of the historical and implied future volatility of our common stock;
•
the risk-free interest rate, which we based on the yield curve of U.S. Treasury securities with periods commensurate with the expected term of the options being valued;
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•
the expected dividend yield, which we estimate to be zero based on the fact that we have never paid cash dividends and have no present intention to pay cash dividends; and
•
the fair value of our common stock on the date of grant.
Stock-based compensation expense for RSUs is recognized on a straight-line basis over the vesting period of the respective award. Stock-based compensation expense for our stock options, both converted and Aptevo granted, is recognized on a straight-line basis over the vesting period of the respective award.
We routinely evaluate the appropriateness of the forfeiture rate based on actual forfeiture experience, analysis of employee turnover, and expectations of future option exercise behavior.
Income Taxes
Income taxes are accounted for using the liability method. Deferred tax assets and liabilities are recognized for future tax consequences attributable to differences between financial statement carrying amounts of existing assets and liabilities and their respective tax bases and net operating loss and tax credit carry forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the year in which those temporary differences are expected to be recovered or settled.
Aptevo’s ability to realize deferred tax assets depends upon future taxable income, as well as the limitations discussed below. For financial reporting purposes, a deferred tax asset must be reduced by a valuation allowance if it is more likely than not that some portion or all of the deferred tax assets will not be realized prior to expiration. Aptevo considers historical and future taxable income, future reversals of existing taxable temporary differences, taxable income in prior carryback years, and ongoing tax planning strategies in assessing the need for valuation allowances. In general, if Aptevo determines that it is more likely than not to realize more than the recorded amounts of net deferred tax assets in the future, Aptevo will reverse all or a portion of the valuation allowance established against its deferred tax assets, resulting in a decrease to the provision for income taxes in the period in which the determination is made. Likewise, if Aptevo determines that it is not more likely than not to realize all or part of the net deferred tax asset in the future, Aptevo will establish a valuation allowance against deferred tax assets, with an offsetting increase to the provision for income taxes, in the period in which the determination is made.
Because tax laws are complex and subject to different interpretations, significant judgment is required. As a result, Aptevo makes certain estimates and assumptions, in (1) calculating Aptevo’s income tax expense, deferred tax assets and deferred tax liabilities, (2) determining any valuation allowance recorded against deferred tax assets and (3) evaluating the amount of unrecognized tax benefits, as well as the interest and penalties related to such uncertain tax positions. Aptevo’s estimates and assumptions may differ significantly from tax benefits ultimately realized.
Segment Reporting
Operating segments are identified as components of an entity about which separate discrete financial information is available for evaluation by the chief operating decision maker (CODM), or decision-making group, in making decisions on how to allocate resources and assess performance. The Company's CODM is the Chief Executive Officer, who views the Company's operations as one operating segment, which is discovery and development of novel oncology therapeutics.
Note 2. Discontinued Operations
The accompanying consolidated financial statements include discontinued operations from the sale of business products and segments.
The following table represents the components attributable to income from discontinued operations in the consolidated statements of operations (in thousands):
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For the Year Ended December 31,
Deferred payments from Medexus $ 523 $ 1,013
Gain on contingent consideration from Kamada 553 —
Income from discontinued operations $ 1,239 $ 1,013
For the year ended December 31, 2023, we collected $0.5 million in deferred payments from Medexus related to IXINITY sales and $0.2 million related to funds released from escrow from the sale of Aptevo BioTherapeutics in 2020. Additionally, we received $0.6 million related to the sale of hyperimmune business to Saol (later acquired by Kamada, Ltd.) as a result of the collection of certain accounts receivable. For the year ended December 31, 2022, we collected $1.0 million in deferred payment from Medexus related to IXINITY sales.
Note 3. XOMA Transaction
On March 29, 2023, we entered into and closed a Purchase Agreement with XOMA pursuant to which we sold to XOMA our right, title and interest in and to all of the deferred payments and a portion of the milestone payments from Medexus under our 2020 LLC Purchase Agreement. Under the terms of our Purchase Agreement with XOMA, we received $9.6 million at closing (the “Closing Payment”) and an additional post-closing payment of $0.05 million (the “Post-Closing Payment”). In exchange for the Closing Payment, we sold to XOMA our right, title and interest to the following payments under the LLC Purchase Agreement: (i) 100% of the Company’s entitlement to receive the deferred payments that may become due and payable following March 29, 2023 (including, for avoidance of doubt, any and all payments earned during Q1 2023), (ii) 25% of the Company’s entitlement to receive the Canadian Approval Milestone Payment; and (iii) 50% of the Company’s entitlement to receive the European Approval Milestone Payments and Net Sales Milestone Payment.
We accounted for the $9.6 million Closing Payment and the $0.05 million post-closing payment from XOMA as other income in accordance with ASC 610-20 Other Income - Gains and Losses from the Derecognition of Nonfinancial Assets in the first quarter of 2023. Contractual rights sold to XOMA represent an intangible asset under ASC 610-20 Other Income - Gains and Losses from the Derecognition of Nonfinancial Assets for which XOMA bears all benefit and Aptevo has no obligations going forward. The transaction was considered a complete sale of a nonfinancial assets. Additionally, XOMA has no recourse against the Company for Medexus’ non-payment absent breach by the Company of its representations, warranties, and covenants in the LLC Purchase Agreement and Aptevo has no role in obtaining regulatory approvals or achieving net sales targets. The Company will continue to account for its portion of future milestones under our LLC Purchase Agreement with Medexus as contingent consideration under ASC 450-30 Gain Contingencies and will record income when proceeds are received.
Note 4. Collaboration Agreements
Alligator Bioscience AB
On July 20, 2017, our wholly owned subsidiary Aptevo Research and Development LLC (Aptevo R&D), entered into a collaboration and option agreement (the Collaboration Agreement) with Alligator Bioscience AB (Alligator), pursuant to which Aptevo and Alligator have been collaboratively developing ALG.APV-527, a lead bispecific antibody candidate simultaneously targeting 4-1BB (CD137), a member of the TNFR superfamily of a costimulatory receptor found on activated T cells, and 5T4, a tumor antigen widely overexpressed in a number of different types of cancer.
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We assessed the arrangement in accordance with ASC 606 and concluded that the contract counterparty, Alligator, is not a customer. As such the arrangement is not in the scope of ASC 606 and is instead treated as a collaborative agreement under ASC 808 – Collaborative Arrangements (ASC 808). In accordance with ASC 808, we concluded that because the Collaboration Agreement is a cost sharing agreement, there is no revenue.
For the years ended December 31, 2023 and 2022, we recorded approximately $2.7 million and $1.7 million, which represent our 50% cost share, in our research and development expense related to the Collaboration Agreement, respectively.
Note 5. Fair Value Measurements
The Company’s estimates of fair value for financial assets and financial liabilities are based on the framework established in the fair value accounting guidance. The framework is based on the inputs used in valuation, gives the highest priority to quoted prices in active markets and requires that observable inputs be used in the valuations when available. The disclosure of fair value estimates in the fair value accounting guidance hierarchy is based on whether the significant inputs into the valuation are observable. In determining the level of the hierarchy in which the estimate is disclosed, the highest priority is given to unadjusted quoted prices in active markets and the lowest priority to unobservable inputs that reflect the Company’s significant market assumptions. The level in the fair value hierarchy within which the fair value measurement is reported is based on the lowest level input that is significant to the measurement in its entirety. The three levels of the hierarchy are as follows:
Level 1— Quoted prices in active markets for identical assets and liabilities;
Level 2— Inputs other than quoted prices in active markets, that are either directly or indirectly observable; and,
Level 3— Unobservable inputs that are supported by little or no market activity, and that are significant to the fair value of the assets or liabilities.
As of December 31, 2023 and 2022, we had $13.2 million and $21.6. million in money market funds, respectively, which are classified as Level 1 investments. The carrying amounts of our money market funds approximate their fair value. As of December 31, 2023 and 2022, we did not have any Level 2 or Level 3 assets or liabilities.
Note 6. Cash and Cash Equivalents
The Company’s cash equivalents are highly liquid investments with a maturity of 90 days or less at the date of purchase and investments in money market funds.
The following table shows our cash and cash equivalents as of December 31, 2023 and 2022:
As of December 31,
Note 7. Property and equipment, net
Property and equipment consist of the following:
For the Year Ended December 31,
Total property and equipment, net $ 895 $ 1,462
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Depreciation expense for the years ended December 31, 2023 and 2022 was $0.6 million and $0.9 million, respectively.
Note 8. Debt
Credit Agreement
On August 5, 2020, we entered into a Credit Agreement, with MidCap Financial (the "Credit Agreement"). The Credit Agreement provided us with up to $25.0 million of available borrowing capacity under a term loan facility. The full $25.0 million was drawn on the closing date of the Credit Agreement.
On March 29, 2023, we used a portion of the proceeds from our Purchase Agreement with XOMA to fully repay the $2.8 million outstanding principal of our MidCap debt and payment of $0.3 million in exit fees. The pre-payment was not considered an amendment to our Credit Agreement since we were required to fully repay the remaining principal balance if we sold IXINITY deferred payment stream and milestones. As of December 31, 2023, we do not have any outstanding debt on the balance sheet.
Note 9. Liability Related to Sale of Royalties
On March 30, 2021, we entered into and closed a Royalty Purchase Agreement with HCR pursuant to which we sold to HCR the right to receive royalty payments made by Pfizer in respect of global net sales of RUXIENCE. Under the terms of the Royalty Purchase Agreement, we have received $47.5 million through December 31, 2023 ($35 million at closing and $12.5 million in milestone payments).
Due to the nature of the transaction, which included a cap on HCR’s rate of return, we recorded a liability related to the proceeds received from HCR of $35.0 million, net of transaction costs of $1.1 million and the 2021 milestone payments in the collective amount of $10.0 million as an additional liability related to the sale of royalties on the consolidated balance sheet as of March 31, 2022 pursuant to ASC 470-10-25, Debt – Sales of Future Revenues or Various Other Measures of Income.
On June 7, 2022, we entered into and closed an amendment to our Royalty Purchase Agreement, resulting in the Company recognizing a $37.2 million gain, which was the total balance of liability related to the sale of royalties on the closing date. The Amendment to Royalty Purchase Agreement eliminated all of our continuing involvement with the cash generating activities related to the royalties and removed all restrictions related to the rate of return and was therefore accounted for under ASC 610-20, Other Income —Gains and Losses from Derecognition of Nonfinancial Assets and ASC 405-20, Liabilities – Extinguishment of Liabilities.
We received a 2022 milestone payment of $2.5 million on February 28, 2023. The proceeds from the 2022 milestone payment were recorded as other income in the consolidated statement of operations for the year ended December 31, 2022.
Due to our Amendment to Royalty Purchase Agreement, we did not have any liability related to sale of royalties as of December 31, 2023. The following table presents the changes in the liability in the prior period related to the sale of royalties under the Royalty Purchase Agreement with HCR (in thousands):
For the year ended December 31, 2022
Liability related to sale of royalties, beginning balance $ 31,045
Proceeds from sale of royalties, net of transaction costs —
Proceeds from milestone payments, net of transaction costs 9,500
Non-cash interest expense 3,416
RUXIENCE royalties paid by Pfizer to HCR (6,779 )
Gain from extinguishment of liability related to sale of royalties (37,182 )
Liability related to sale of royalties, ending balance —
Current portion of liability related to sale of royalties —
Liability related to sale of royalties, non-current $ —
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Note 10. Leases and Contingencies
Office Space Lease – Operating
We have an operating lease related to our office and laboratory space in Seattle, Washington. This lease was amended in March 2019 to extend the term through April 2030 and provide two options to extend the lease term, each by five years, as well as a one-time option to terminate the lease in April 2023, with nine months’ notice, or by July 2022. We had previously determined we should not include any periods after the termination option when evaluating this amendment as we were not reasonably certain to not exercise the option, therefore we recorded our liability through April 30, 2023.
On May 26, 2022, we amended our office and laboratory lease to remove the one-time termination option. In exchange for removing the termination option, we received six months of free rent. As a result, we recorded an additional $4.4 million of lease liability and right-of-use asset on the consolidated balance sheet on the date of the amendment. As of December 31, 2023, we are not reasonably certain to exercise the two options to extend the lease term. Therefore, pursuant to our May 26, 2022 amendment, we recorded our lease liability through April 30, 2030.
For the years ended December 31, 2023 and 2022, we recorded $0.8 million and $0.7 million, respectively, related to variable expense due to true ups of operating costs or real estate taxes.
Equipment Leases - Operating and Financing
As of December 31, 2023, we did not have any operating or financing leases for equipment.
Components of lease expense:
For the year endedDecember 31, For the year endedDecember 31,
Right-of-use assets acquired under operating leases:
As of December 31, As of December 31,
Seattle office lease, including amendment 4,881 5,303
Total right-of-use assets $ 4,881 $ 5,303
Lease payments:
For the year endedDecember 31, For the year endedDecember 31,
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Future minimum payments as of December 31, 2023 are as follows:
(in thousands)
Total future minimum lease payments 8,715
Less: imputed interest (2,636 )
As of December 31, 2023, the long-term and current portion of the lease liabilities were $5.4 million and $0.7 million, respectively. As of December 31, 2022, the long-term and current portion of the lease liabilities were $6.1 million and $0.4 million, respectively.
As of December 31, 2023, the weighted average remaining lease term and weighted discount rate for operating leases was 6.3 years and 12.03%. As of December 31, 2022, the weighted average remaining lease term and weighted discount rate for operating leases was 7.3 years and 12.03%.
Note 11. Net Income (Loss) per Share
Basic net income (loss) per share is calculated by dividing the net income (loss) by the weighted-average number of common shares outstanding for the period. The weighted-average number of common shares outstanding includes the shares held in abeyance resulting from the exercise of warrants because there is no consideration required for delivery of shares. Diluted net income (loss) per share is computed by dividing the net income (loss) by the weighted-average number of common share equivalents outstanding for the period using the as-if converted method. For the purpose of this calculation, warrants, stock options and restricted stock units ("RSUs") are only included in the calculation of diluted net income (loss) per share when their effect is dilutive.
We utilize the control number concept in the computation of diluted earnings per share to determine whether potential common stock instruments are dilutive. The control number used is income (loss) from continuing operations or income from discontinued operations. The control number concept requires that the same number of potentially dilutive securities applied in computing diluted earnings per share from continuing operations be applied to all other categories of income or loss, regardless of their anti-dilutive effect on such categories.
Common stock equivalents include warrants, stock options and unvested RSUs.
The following table presents the computation of basic and diluted net income (loss) per share (in thousands, except share and per share amounts):
For the Year Ended December 31,
Net (loss) income from continuing operations $ (18,650 ) $ 7,014
Income from discontinued operations 1,239 1,013
Basic and diluted net (loss) income per share from continuing operations:
Basic and diluted net income per share from discontinued operations:
Shares used in calculation
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The following table represents all potentially dilutive shares:
As of December 31,
(in thousands, except for per share amounts) 2023 2022
Outstanding options to purchase common stock 442 364
We use the treasury stock method when determining dilutive shares. For the year ended December 31, 2023, the Company was in a net loss position, therefore the share number used to calculate diluted earnings per share is the same as the basic earnings per share. As of December 31, 2022, we determined RSUs were the only dilutive shares, therefore included in the diluted earnings per share calculation.
Note 12. Equity
Warrants - 2019
In March 2019, as part of a public offering, we issued warrants to purchase up to 1,725,000 shares of our common stock, 1,571,429 of which have an exercise price of $18.20 per share and have a five-year life, and 153,571 of pre-funded warrants with an exercise price of $0.14 per share. The pre-funded warrants had a ten-year life and would have expired on March 11, 2029; however, all of the pre-funded warrants were exercised in March 2019. We determined the warrants do not meet liability classification pursuant to ASC 480 – Distinguishing Liabilities from Equity. These are therefore included within equity on our consolidated balance sheets. For the year ended December 31, 2023 and 2022, the Company did not have any of its warrants exercised. As of December 31, 2023 and 2022, there were warrants to purchase 350,589 shares of common stock outstanding, which expire in March 2024.
August 2023 Public Raise
On August 4, 2023, we completed a public offering of common stock and warrant, as follows:
•
2,221,550 shares of common stock at a price of $0.62 per share.
•
$0.62 per pre-funded warrant, to purchase up to 5,842,967 shares of common stock at an exercise price of $0.001 per share and will not expire prior to exercise. As of December 31, 2023, all pre-funded warrants have been exercised.
•
Series A and Series B common warrants to purchase up to an aggregate of 16,129,034 shares of common stock at an exercise price of $0.62 per share. The remaining 1,872,516 Series A and 58,000 Series B common warrants will expire on August 4, 2028 and February 4, 2025, respectively.
We received net proceeds of $4.3 million, net of transaction costs, as a result of this offering. In the fourth quarter of 2023, an aggregate of 14,198,518 Series A and Series B common warrants were exercised as part of our November 2023 warrant inducement agreement with certain holders of our common warrants. As of December 31, 2023, 3,809,652 shares of common stock have been issued with the remaining 10,388,866 shares held in abeyance and reserved for issuance at a later date. As of December 31, 2023, there were 1,872,516 Series A and 58,000 Series B common warrants outstanding with an exercise price of $0.62 per share.
November 2023 Warrant Inducement
On November 9, 2023, we entered into a warrant inducement agreement (the "Inducement Agreement") with certain holders of our Series A and Series B common warrants issued in connection with our August 2023 public offering. Pursuant to the Inducement Agreement, certain holders agreed to exercise for cash 6,192,001 Series A and 8,006,517 Series B common warrants at a reduced exercise price of $0.233. The Company also agreed to issue new common stock warrants to purchase a number of shares of common stock equal to 200% of the number of shares of common stock issued upon exercise of the existing Series A and Series B warrants as applicable. We received $3.3 million in gross proceeds from the exercise of these warrants less total issuance costs of $2.3 million. Issuance costs include banker and legal fees $0.2 million and non-cash warrant modification costs of $2.1 million. Because the modification represented a short-term inducement, modification accounting was only performed on the warrants that
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were actually exercised under the agreement. The Company recognized the $2.1 million modification date incremental value of the modified warrants and additional warrants issued as compared to the original warrants as an issuance cost of the warrant exercise. Additionally, pursuant to the Inducement Agreement, we issued an aggregate of 28,397,036 new Series A and new Series B warrants as follows:
•
12,384,002 New Series A common warrants to purchase an aggregate of up to 12,384,002 shares of common stock at $0.233 per share, of which 6,192,001 Series A-1 common warrants are immediately exercisable and 6,192,001 Series A-2 common warrants will be exercisable at any time on or after the Stockholder Approval Date. The Series A-1 and Series A-2 common warrants have terms of four years and eight months, and five years, respectively.
•
16,013,034 New Series B common warrants to purchase an aggregate of up to 16,013,034 shares of common stock at $0.233 per share, of which 8,006,517 Series B-1 common warrants are immediately exercisable and 8,006,517 Series B-2 common warrants will be exercisable at any time on or after the Stockholder Approval Date. The Series B-1 and Series B-2 common warrants have terms of fourteen months and twenty-four months, respectively.
If the new warrants are exercised, we may receive up to an additional $6.6 million in gross proceeds. As of December 31, 2023, there were 6,192,001 Series A-1, 6,192,001 Series A-2, 8,006,517 Series B-1 and 8,006,517 Series B-2 common warrants outstanding with an exercise price of $0.233 per share.
Number ofShares Weighted-Average Exercise Price Weighted-AverageRemaining Term
Exercised with shares held in abeyance at December 31, 2023 10,388,866 - -
Common warrants outstanding at December 31, 2023, includes 6,192,001 Series A-2 and 8,006,517 Series B-2 common warrants that became exercisable upon shareholder approval as of February 5, 2024.
Aptevo uses Black-Scholes valuation model for estimating the incremental fair value of the exchanged common warrants included in the Inducement Agreement. Set forth below are the assumptions used in valuing the common warrants issued:
For the Year Ended December 31,
Expected dividend yield 0.00%
Expected volatility 104.01%
Risk-free interest rate 5.40%
Expected average life of warrants 1.2 - 5 years
Equity Distribution Agreement
On December 14, 2020, we entered into an Equity Distribution Agreement with Piper Sandler. The Equity Distribution Agreement provided that, upon the terms and subject to the conditions set forth therein, we may issue and sell through Piper Sandler, acting as sales agent, shares of our common stock, $0.001 par value per share having an aggregate offering price of up to $50.0 million. This offering superseded and replaced the program we commenced in December 2017. We had no obligation to sell any such shares under the Equity Distribution Agreement. The sale of such shares of common stock by Piper Sandler would be effected pursuant to a Registration Statement on Form S-3 which we filed on December 14, 2020, and expired in December 2023. For the year ended December 31, 2023, we issued 730,913 shares of our common stock at an average share price of $2.26 under the Equity Distribution Agreement. We received $1.6 million in proceeds from issuance of these shares. For the year ended December 31,
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2022, we issued 1,452,065 shares of our common stock at an average share price of $4.92 under the Equity Distribution Agreement. We received $7.0 million in proceeds from issuance of these shares.
Lincoln Park Purchase Agreement
On February 16, 2022, we entered into a Purchase Agreement (2022 Purchase Agreement) and a Registration Rights Agreement with Lincoln Park. The 2022 Purchase Agreement and Registration Rights Agreement replaced our 2018 Purchase Agreement and Registration Rights Agreement with Lincoln Park. Under the 2022 Purchase Agreement, Lincoln Park committed to purchase up to $35.0 million of our common stock over a 36-month period commencing after the satisfaction of certain conditions, which are within our control, as set forth in the Purchase Agreement. The purchase price per share will be based on prevailing market prices; provided, however, that the prevailing market price is not below $1.00. We agreed to and issued 99,276 shares of our common stock to Lincoln Park for no cash consideration as an initial fee for its commitment to purchase shares of our common stock under the 2022 Purchase Agreement.
For the year ended December 31, 2023, we issued 300,000 shares of our common stock to Lincoln Park under the 2022 Purchase Agreement and we received $0.5 million in proceeds from issuance of these shares. For the year ended December 31, 2022, we did not issue any shares of common stock for cash consideration to Lincoln Park under the 2022 Purchase Agreement.
Rights Plan
On November 8, 2020, our Board of Directors (the "Board") approved and adopted a Rights Agreement (the "Rights Agreement"), dated as of November 8, 2020, by and between the Company and Broadridge Corporate Issuer Solutions, Inc., as rights agent, pursuant to which the Board declared a dividend of one preferred share purchase right (each, a "Right") for each outstanding share of the Company’s common stock held by stockholders as of the close of business on November 23, 2020. One Right also will be issued together with each Common Share issued by the Company after November 23, 2020, but before the Distribution Date (as defined below) (or the earlier redemption or expiration of the Rights) and, in certain circumstances, after the Distribution Date. When exercisable, each Right initially would represent the right to purchase from the Company one one-thousandth of a share of a newly-designated series of preferred stock, Series A Junior Participating Preferred Stock, par value $0.001 per share, of the Company. Subject to various exceptions, the Rights become exercisable in the event any person (excluding certain exempted or grandfathered persons) becomes the beneficial owner of ten percent (10%) or more of the Company’s common stock without the approval of the Board. On November 2, 2023, we entered into Amendment No. 3 to the Rights Agreement and extended the expiration of such agreement to November 4, 2024 and changed the exercise price to $2.02 per one one-thousandth of a Series A Junior Participating Preferred Share, subject to adjustment.
2018 Stock Incentive Plan
On June 1, 2018, at the 2018 Annual Meeting of the Stockholders, the Company’s stockholders approved a new 2018 Stock Incentive Plan (the "2018 SIP"), which replaced the Restated 2016 Plan on a go-forward basis. All stock options, RSUs or other equity awards granted subsequent to June 1, 2018 have been and will be issued out of the 2018 SIP, which has 0.3 million shares of Aptevo common stock authorized for issuance. The 2018 Plan became effective immediately upon stockholder approval at the 2018 Annual Meeting of the Stockholders. Any shares subject to outstanding stock awards granted under the 2016 SIP that (a) expire or terminate for any reason prior to exercise or settlement; (b) are forfeited because of the failure to meet a contingency or condition required to vest such shares or otherwise return to the Company; or (c) otherwise would have returned to the 2016 SIP for future grant pursuant to the terms of the 2016 Plan (such shares, the “Returning Shares”) will immediately be added to the share reserve under the 2018 SIP as and when such shares become Returning Shares, up to a maximum of 0.3 million shares.
On June 7, 2022, at the 2022 Annual Meeting of Stockholders, our stockholders approved the Amended and Restated 2018 SIP to increase the number of shares authorized for issuance under the 2018 SIP by 0.5 million shares of common stock. As of December 31, 2023, there are approximately 0.1 million shares available to be granted under the 2018 SIP.
Stock options and RSUs under the Amended and Restated 2018 SIP generally vest pro rata over a one-year or three-year period. Stock options terminate ten years from the grant date, though the specific terms of each grant are determined individually. The Company’s executive officers, members of our board of directors, and certain other employees and consultants may be awarded options and/or RSUs with different vesting criteria, and awards granted to non-employee directors will vest over a one-year period. Option exercise and RSU grant prices for new awards
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granted by the Company equal the closing price of the Company’s common stock on the Nasdaq Capital Market on the date of grant.
Stock-Based Compensation Expense
Stock-based compensation expense includes amortization of stock options and RSUs granted to employees and non-employees and has been reported in our consolidated statements of operations as follows:
For the Year Ended December 31,
Research and development $ 684 $ 196
Total stock-based compensation expense $ 2,193 $ 1,802
The Company accounts for stock-based compensation by measuring the cost of employee services received in exchange for all equity awards granted based on the fair value of the award as of the grant date. The Company recognizes the compensation expense over the vesting period. All assumptions used to calculate the grant date fair value of non-employee equity awards are generally consistent with the assumptions used for equity awards granted to employees. In the event the Company terminates any of its consulting agreements, the unvested equity underlying the agreements would also be forfeited.
Stock Options
Aptevo utilizes the Black-Scholes valuation model for estimating the fair value of all stock options granted. Set forth below are the assumptions used in valuing the stock options granted:
For the Year Ended December 31,
Expected dividend yield 0.00% 0.00%
Risk-free interest rate 4.18% 1.71%
Expected average life of options 5 years 5 years
Management has applied an estimated forfeiture rate of 29% and 30% for the year ended December 31, 2023 and 2022, respectively. Expected volatility decreased, as our stock price fluctuated from a low of $0.17 to a high of $2.54 throughout the year ended December 31, 2023, compared to a low of $2.00 to a high of $8.42 throughout the year ended December 31, 2022.
The following is a summary of option activity for the year ended December 31, 2023:
Number ofShares Weighted-AverageExercise Price Weighted-AverageRemaining Term
Exercised — — —
As of December 31, 2023, we had $0.8 million of unrecognized compensation expense related to options expected to vest over a weighted average period of 0.7 years. The weighted-average grant date fair value per share of options granted during the years ended December 31, 2023 and 2022 was $1.68 and $4.36, respectively. The aggregate intrinsic value of options exercised for the years ended December 31, 2023 and 2022 was $0. The total fair value of stock options vested for the years ended December 31, 2023 and 2022 was $1.2 million and $1.3 million, respectively.
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The aggregate intrinsic value in the table above represents the total pretax intrinsic value (the difference between the closing stock price of Aptevo’s common stock on the last trading day of December 2023 and the exercise price, multiplied by the number of in the money options) that would have been received by the option holders had all the option holders exercised their options on the last trading day of the quarter.
Restricted Stock Units
The following is a summary of restricted stock activity for the year ended December 31, 2023:
Number ofUnits WeightedAverage FairValue per Unit
As of December 31, 2023, we had $0.8 million of unrecognized stock-based compensation expense related to RSUs expected to vest over a weighted average period of 1.2 years. As of December 31, 2022, we had $1.5 million of unrecognized stock-based compensation expense related to RSUs expected to vest over a weighted average period of 1.6 years.
The fair value of each RSU has been determined to be the closing trading price of the Company’s common stock on the date of grant as quoted on the Nasdaq Capital Market.
Note 13. 401(k) Savings Plan
Aptevo has established a defined contribution savings plan under Section 401(k) of the Internal Revenue Code, as amended. The 401(k) Plan covers all employees. Under the 401(k) Plan, employees may make elective salary deferrals. Aptevo currently provides for matching of qualified deferrals up to 50% of 401(k) employee deferral contributions, based on a maximum employee deferral rate of 6% of compensation. During the year ended December 31, 2023 and 2022, Aptevo’s related share of matching contributions was approximately $0.2 million.
Note 14. Income Taxes
We did not have an income tax benefit or income tax expense from continuing operations in the years ended December 31, 2023 and 2022.
The components of income (loss) before income taxes were as follows (in thousands):
Year ended December 31,
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The tax effects of temporary differences that give rise to significant portions of the deferred tax assets and deferred tax liabilities are presented below:
For the Year Ended December 31,
Capitalized research expenditures 5,859 3,361
Stock-based compensation 963 912
Other deferred tax assets 380 496
Gain related to sale of future royalties — 2,016
Deferred tax assets, net of valuation 1,027 1,124
Net deferred tax assets $ — $ —
The Company evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets. Based on the Company’s history of operating losses, including a three-year cumulative loss position as of December 31, 2023, the Company has concluded that it is more likely than not that the benefit of its deferred tax assets will not be realized. Accordingly, the Company provided a full valuation allowance for its net deferred tax assets as of December 31, 2023 and 2022. The valuation allowance increased by $4.2 million during the year ended December 31, 2023. The increase in the valuation allowance during the year ended December 31, 2023 was due primarily to a an increase in deferred tax assets resulting from the orphan drug credit generated during the period, Section 174 capitalized research expenditures, and the generation of federal and state NOLs during the period.
As of December 31, 2023 and 2022, we have recorded gross federal net operating losses (NOL) carryforwards of approximately $168.2 and $156.2 million, respectively, gross state NOL carryforwards of approximately $70.5 and $71.1 million, respectively, and tax credit carryforwards of $6.1 million and $4.9 million, respectively. Approximately $15.2 million of federal losses and credits would begin to expire in 2037, while $153 million of federal losses may be carried forward indefinitely. The state net operating losses will begin to expire in varying periods.
The Company completed an IRC Section 382/383 study on its federal and state tax attributes based on an ownership change that occurred during 2021. Based on the study, there are not any permanent limitations on our ability to use federal and state net operating loss carryforwards and tax credits. We may experience ownership changes in the future as a result of subsequent shifts in our stock ownership, some of which may be outside of our control. If an ownership change occurs in the future, our ability to use our net operating loss carryforwards and credits could be limited.
The Company files income tax returns in the U.S. and several state jurisdictions and are open to review by taxing authorities for the 2016 tax filings and thereafter.
We are subject to the accounting guidance for uncertain income tax positions. We believe that our income tax positions and deductions will be sustained on audit and do not anticipate any adjustments that will result in a material adverse effect on our financial condition, results of operations, or cash flow. Our policy for recording interest and penalties associated with audits and uncertain tax positions is to record such items as a component of income tax expense, and amounts recognized to date are insignificant. No uncertain income tax positions are recorded, and we do not expect our uncertain tax position to change during the next twelve months.
The reconciliation of the federal statutory income tax rate to the Company’s effective income tax from continuing operations is as follows:
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Year ended December 31,
Federal tax at statutory rates 21.0 % 21.0 %
State taxes, net of federal benefit -0.2 % -1.8 %
Change in valuation allowance -23.8 % -12.5 %
Permanent differences -0.1 % 0.8 %
Stock-based compensation -2.6 % 10.1 %
Total income tax benefit 0.0 % 0.0 %
Note 15. Subsequent Events
On January 2 and February 15, 2024, holders of our August 2023 common warrants provided notice to release 2,864,870 and 1,130,000 shares of common stock from abeyance, respectively, which were then issued, leaving a remainder of 6,393,996 shares in abeyance. As of March 5, 2024, we have 23,472,436 shares of common stock issued and outstanding.
On February 5, 2024, the Company held a Special Meeting of Stockholders (the “Special Meeting”), at which the Company’s stockholders:
1.
Approved an amendment to the Company’s Amended and Restated Certificate of Incorporation to effect a reverse stock split of the Company’s common stock at a ratio in the range of 1-for-15 to 1-for-44, with such ratio to be determined in the discretion of the Board of Directors of the Company (the “Board”) and with such reverse stock split to be effected at such time and date, if at all, as determined by the Board in its sole discretion (Proposal 1);
2.
Approved, in accordance with Nasdaq Listing Rule 563(d), the issuance of more than 19.99% of the Company’s outstanding common stock, par value $0.001 per share, issuable upon the exercise of New Series A-2 Warrants and New Series B-2 Warrants with the right for such potential exercise to occur immediately following the date upon which stockholders approved this proposal (Proposal 2); and
3.
Approved an authorization to adjourn the Special Meeting, if necessary or appropriate, to solicit additional proxies if there are not sufficient votes in favor of Proposal 1 or Proposal 2.
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Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
None.
Item 9A. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
As of December 31, 2023, management, with the participation of our Chief Executive Officer and Chief Financial Officer, performed an evaluation of the effectiveness of our disclosure controls and procedures as defined in Rules 13a- 15(e) and 15d-15(e) of the Exchange Act. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of December 31, 2023, the design and operation of our disclosure controls and procedures were effective to provide reasonable assurance that information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms and to provide reasonable assurance that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.
Management’s Report on Internal Control over Financial Reporting
Management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Rule 13a-15(f) of the 1934 Act. Management has assessed the effectiveness of our internal control over financial reporting as of December 31, 2023 based on criteria established in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. As a result of this assessment, management concluded that, as of December 31, 2023, our internal control over financial reporting was effective in providing reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles.
Changes in Internal Control over Financial Reporting
There have been no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended December 31, 2023, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Limitations on Controls
Because of inherent limitations, disclosure controls and internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Item 9B. Other Information.
None.
Item 9C. Disclosure Regarding Foreign Jurisdictions That Prevent Inspections.
Not Applicable.
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PART III
Item 10. Directors, Executives Officers and Corporate Governance.
Names of Directors and Other Information
Aptevo’s Board is divided into three classes. Each class consists, as nearly as possible, of one-third of the total number of directors, and each class has a three-year term.
The Board presently has six members. The following are brief biographies of each person serving as a member of our Board.
Name Age Principal Occupation
Marvin L. White 62 President and Chief Executive Officer of Aptevo
Grady Grant, III 68 EVP/Partner of Vanigent BioPharm
Marvin L. White has served as our President, Chief Executive Officer and as a member of our Board since August 2016. From 2010 to 2016, Mr. White served as a director of Emergent, and in 2020, he rejoined the Emergent Board of Directors. From 2008 to 2014, Mr. White served as the Chief Financial Officer of St. Vincent Health, and was responsible for finance, materials management, accounting, patient financial services and managed care for all 19 hospitals and 36 joint ventures. Prior to joining St. Vincent Health in 2008, Mr. White was the Chief Financial Officer of Lilly USA, LLC, a subsidiary of Eli Lilly and Company, where he also held leadership positions in treasury and corporate finance and investment banking in the Corporate Strategy Group. He serves on the Board of Directors of OneAmerica Financial Insurance Partners, Inc., a mutual insurance and financial services company based in Indianapolis, Indiana and Delta Dental of Washington, a non-profit company. Prior to taking the role of President and Chief Executive Officer of Aptevo, Mr. White served on the Board of Directors of Washington Prime Group, a New York Stock Exchange-listed real estate investment trust (REIT) that invests in shopping centers, and CoLucid Pharmaceuticals, Inc., a pharmaceutical company that was publicly-traded until its acquisition by Eli Lilly in 2017. Mr. White earned a bachelor of science degree from Wilberforce University in Accounting and his MBA degree in Finance from Indiana University. Mr. White’s tenure as Chief Executive Officer of Aptevo and his director experience at Emergent provides valuable management and leadership experience. In addition, Mr. White provides crucial insight to the Board on company strategic planning and operations. For these reasons, the Board believes Mr. White is qualified to serve on Aptevo’s Board.
Daniel J. Abdun-Nabi has served as a member of our Board since August 2016. Mr. Abdun-Nabi served as the President and Chief Executive Officer of Emergent from 2012 to 2019 and as a director of Emergent from 2009 to 2019. Prior to that, Mr. Abdun-Nabi served in other various leadership positions at Emergent, including President and Chief Operating Officer from 2007 to 2012, Corporate Secretary from 2004 to 2008, Senior Vice President, Corporate Affairs and General Counsel from 2004 to 2007, and Vice President and General Counsel from May 2004 to December 2004. Before joining Emergent, Mr. Abdun-Nabi was General Counsel for IGEN International, Inc., a biotechnology company, and its successor BioVeris Corporation, from 1999 to 2004, and Senior Vice President, Legal Affairs, General Counsel and Secretary of North American Vaccine, Inc., a publicly traded vaccine company acquired by Baxter International Inc. In 2000. Mr. Abdun-Nabi earned a bachelor degree in political science from the University of Massachusetts Amherst, a J.D. from the University of San Diego School of Law and an LLM from Georgetown
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University Law Center. The Board believes that Mr. Abdun-Nabi is qualified to serve on Aptevo's Board because of his extensive experience and knowledge of the biotechnology industry and Aptevo products.
Grady Grant, III has served as a member of our Board since August 2016. Mr. Grant is currently serving as EVP/Partner of Vanigent BioPharm, and until April 2022, was Senior Vice President of Evolve Biosystems, a biotechnology company that specializes in providing microbiome-based products to maintain a healthy newborn gut microbiome. Previously, from 2020 to 2021, he was Interim Chief Commercial Officer for New Vision Pharmaceuticals LLC, a contract pharmaceutical development and manufacturing company specializing in blow-fill-seal packaging, from 2018 to 2020, he was the Vice President of Sales for Tissue Tech Limited, a regenerative medicine company, and from 2011 to 2018, he worked as Vice President of Medical Sales for Mead Johnson Nutrition Company, a public company focused on pediatric nutrition. Prior to that, he served for 30 years at Eli Lilly and Company in various capacities, including service as Vice President of Sales Neuroscience from 2006 to 2011. Mr. Grant earned a bachelor degree in pharmaceutical science from Temple University. Mr. Grant is also certified as a Board Director by the National Association of Corporate Directors. The Board believes that Mr. Grant is qualified to serve on Aptevo's Board because of his knowledge of the pharmaceutical industry and marketed products.
Zsolt Harsanyi, Ph.D. Has served as a member of our Board since August 2016. Dr. Harsanyi has served on the Board of Directors of Emergent since 2004 and as its Chairman since April 1, 2022 and as Chairman of the Board of Directors of N-Gene Research Laboratories, Inc., a privately-held biotechnology company, since 2011. Prior to that, Dr. Harsanyi served as Chief Executive Officer and Chairman of the Board of Directors of Exponential Biotherapies Inc., a private biotechnology company, from 2004 to 2011. Prior to that, Dr. Harsanyi served as President of Porton International Inc., a pharmaceutical and vaccine company, from January 1983 to December 2004. In 1996, Dr. Harsanyi founded Dynport Vaccine Company LLC. Prior to that, he was Vice President of Corporate Finance at E.F. Hutton, Inc. Dr. Harsanyi directed the first assessment of biotechnology for the U.S. Congress’ Office of Technology Assessment, served as a consultant to the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research and was on the faculties of Microbiology and Genetics at Cornell Medical College. Dr. Harsanyi received his bachelor degree from Amherst College and his Ph.D. in genetics from Albert Einstein College of Medicine. The Board believes Dr. Harsanyi is qualified to serve on Aptevo’s Board because of his industry experience, his senior executive and financial positions, and his public company audit committee chair experience.
Barbara Lopez Kunz has served as a member of our Board since August 2016. Ms. Kunz retired at the end of March 2023 as the President and Global Chief Executive of the Drug Information Association, a non-profit health care company. Ms. Kunz serves as Vice-Chair of the Board of Directors of Children’s National Health System Research Institute and on the Board of Directors of Caidyo, a clinical research organization. From 2007 to 2013, she worked as President of Health and Life Sciences Global Business at Battelle Memorial Institute, a private nonprofit applied science and technology development company. Prior to that, she worked as Executive VP/GM for Thermo Fisher Scientific Inc.’s Fisher Biosciences from 2003 to 2007 and led the Latin America regional business from 2000 to 2003 at Uniqema, a company acquired by Croda International plc in 2006. Ms. Kunz also worked as Head of Strategy/M&A of Dupont from 1997 to 1998 and was the Global VP for the Enterprise Business Group of Imperial Chemical Industries (now AstraZeneca/Croda) from 1993 to 1997. Ms. Kunz earned bachelor degrees in both biology and chemistry from Thiel College, MBA coursework at Cleveland State University, an MS in polymer science from the University of Akron and is certified in INSEAD’s international executive program. She is also certified as a Board Director by the National Association of Corporate Directors. The Board believes that Ms. Kunz is qualified to serve on Aptevo’s Board because of her leadership experience, her business acumen and knowledge of the healthcare industry.
John E. Niederhuber, M.D. has served on our Board and as our Chairman (previously Vice Chairman and Lead Independent Director) since August 2016. Dr. Niederhuber is currently an adjunct professor of surgery and oncology at The Johns Hopkins University School of Medicine. Dr. Niederhuber is the former Executive Vice President of the Inova Health System, Founder of the Inova Translational Medicine Institute (“Inova”), and founding President and Chief Executive Officer of the Genomics and Bioinformatics Research Institute, a joint venture between Inova and the University of Virginia. Dr. Niederhuber joined the Inova Health System in 2010 as Executive Vice President of the Health System and Chief Executive Officer of Inova. He officially retired from his position at Inova in 2019. Prior to Inova, he served as the Director of the National Cancer Institute, the National Institutes of Health from 2006 to 2010 and as the Director of the University of Wisconsin Comprehensive Cancer Center and professor of
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surgery and oncology (member of the McArdle Laboratory) at the University of Wisconsin School of Medicine from 1997 to 2005. He chaired the Department of Surgery at Stanford University School of Medicine from 1991 to 1997 and held professorships at The Johns Hopkins University School of Medicine from 1987 to 1991 and at the University of Michigan from 1973 to 1987. Dr. Niederhuber also previously served on the Board of Directors of Emergent from 2010 to 2016. Dr. Niederhuber earned a bachelor of science from Bethany College and his M.D. from The Ohio State University School of Medicine. He is a member of the National Academy of Medicine. The Board believes that Dr. Niederhuber is qualified to serve on Aptevo's Board because he provides valuable insights to the Board through his experience in the field of oncology, immunology, genomics and in the business of healthcare.
Names of Officers and Biographical Information
Set forth below is information regarding the positions, ages and business experience of each of our executive officers as of March 1, 2024. Biographical information with regard to Mr. White is presented under “Election of Directors” in this report.