NEKTAR THERAPEUTICS
For the period ended Sep 30, 2024. Filed Nov 8, 2024.
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Sep 30, 2024 · Filed Nov 8, 2024
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Notes to Condensed Consolidated Financial Statements
September 30, 2024
Note 1 — Organization and Summary of Significant Accounting Policies
Organization
Nektar Therapeutics (Nektar, we) is a clinical stage, research-based drug discovery biopharmaceutical company headquartered in San Francisco, California and incorporated in Delaware, focused on discovering and developing innovative medicines in the field of immunotherapy. Within this growing field, we direct our efforts toward creating new immunomodulatory agents that selectively induce, amplify, attenuate or prevent immune responses in order to achieve desired therapeutic outcomes. Our pipeline of clinical-stage and preclinical-stage immunomodulatory agents targets the treatment of autoimmune diseases (e.g. rezpegaldesleukin and NKTR-0165, respectively) and cancer (e.g. NKTR-255).
Our research and development activities have required significant ongoing investment to date and are expected to continue to require significant investment. As a result, we expect to continue to incur substantial losses and negative cash flows from operations in the future. We have financed our operations primarily through cash generated from licensing, collaboration and manufacturing agreements and financing transactions. As of September 30, 2024, we had approximately$249.0 million in cash and investments in marketable securities.
Sale of Manufacturing Facility
On November 1, 2024, we entered into an Asset Purchase Agreement (the APA) with an affiliate (the Purchaser) of Ampersand Management LLC d/b/a Ampersand Capital Partners (Ampersand), for the sale of our manufacturing facility located in Huntsville, Alabama (the Facility) and certain other manufacturing assets related thereto, including the assignment of our existing manufacturing and supply obligations, for consideration of $70 million in cash (subject to customary closing costs and adjustments based on closing net working capital, closing inventory and the amount of any indebtedness assumed by the Purchaser) and an approximate 20% equity ownership at the time of close in the Purchaser. See Note 10 for additional information.
Financing Transactions
During the nine months ended September 30, 2024, we entered into the following transactions:
On February 12, 2024, for total cash consideration paid of $3.0 million, we repurchased from Bristol Myers Squibb Company (BMS)8.3 million shares of Nektar's common stock that were previously sold to BMS, which we report as treasury stock on our Condensed Consolidated Balance Sheets. See Note 6 for additional information.
On March 4, 2024, we entered into a Securities Purchase Agreement with TCG Crossover Fund II, L.P. (TCG), pursuant to which we issued a pre-funded warrant to TCG to purchase 25,000,000 shares of Nektar’s common stock for gross proceeds of $30.0 million (or a purchase price of $1.20 per share of common stock that can be issued upon exercise of the pre-funded warrant). On May 28, 2024, we filed with the SEC a registration statement on Form S-3 (file no. 333-279760) registering for the resale of up to 25,000,000 shares of Nektar’s common stock upon exercise of the pre-funded warrant issued to TCG pursuant to the Securities Purchase Agreement. The registration statement became effective on June 5, 2024. See Note 5 for additional information.
On March 4, 2024, for total cash consideration received of $15.0 million, we entered into an amendment (the Amendment) with entities managed by Healthcare Royalty Management, LLC (collectively, HCR) to remove the cap on royalties previously sold to HCR under a Purchase and Sale Agreement (the 2020 Purchase and Sale Agreement). See Note 3 for additional information.
Restructuring Plans
In April 2022, we announced the termination of the bempegaldesleukin program and a new strategic reorganization and cost restructuring plan (together, the 2022 Restructuring Plan), pursuant to which we completed an approximate 70% reduction of our workforce during 2022. We also decided to seek a sublease for certain of our leased premises in San Francisco, CA, including all of our office space on Third St. and portions of our office and laboratory space on Mission Bay Blvd. South.
In April 2023, we announced Eli Lilly and Company's (Lilly) decision to terminate our license agreement (the Lilly Agreement) for the development of rezpegaldesleukin, as well as a new strategic reprioritization and cost restructuring plan (the 2023 Restructuring Plan). Under the 2023 Restructuring Plan, we reduced our San Francisco-based workforce by approximately 60%. In addition, under the 2023 Restructuring Plan, we decided to seek a sublease for our remaining office and laboratory space on Mission Bay Blvd. South which we had not planned to sublease pursuant to the 2022 Restructuring Plan.
We have regained full rights to rezpegaldesleukin from Lilly, and we initiated a Phase 2b study of rezpegaldesleukin in patients with moderate-to-severe atopic dermatitis in October 2023 and a Phase 2b study of rezpegaldesleukin in patients with severe-to-very severe alopecia areata in March 2024. We will also explore other auto-immune indications for the development of rezpegaldesleukin.
We have incurred significant costs resulting from the 2022 and 2023 Restructuring Plans. See Note 7 for additional information on the effect on our Condensed Consolidated Financial Statements.
Basis of Presentation and Principles of Consolidation
Our Condensed Consolidated Financial Statements include the financial position, results of operations and cash flows of Nektar Therapeutics and our wholly-owned subsidiaries. We have eliminated all intercompany accounts and transactions in consolidation.
We prepared our Condensed Consolidated Financial Statements following the requirements of the Securities and Exchange Commission (SEC) for interim reporting. As permitted under those rules, we may condense or omit certain footnotes or other financial information that are normally required by U.S. generally accepted accounting principles (GAAP) for annual periods. In the opinion of management, these financial statements include all normal and recurring adjustments that we consider necessary for the fair presentation of our financial position and operating results.
Our Condensed Consolidated Financial Statements are denominated in U.S. dollars. Accordingly, changes in exchange rates between the applicable foreign currency and the U.S. dollar will affect the translation of each foreign subsidiary’s financial results into U.S. dollars for purposes of reporting our consolidated financial results. We include translation gains and losses in accumulated other comprehensive income (loss) in the stockholders’ equity section of our Condensed Consolidated Balance Sheets.
Our comprehensive loss consists of our net loss plus our foreign currency translation gains and losses and unrealized gains and losses on available-for-sale securities. There were no significant reclassifications out of accumulated other comprehensive income (loss) to the statements of operations during the three and nine months ended September 30, 2024 and 2023 except as otherwise disclosed below in Note 3.
The accompanying Condensed Consolidated Financial Statements are unaudited. The Condensed Consolidated Balance Sheet data as of December 31, 2023 was derived from the audited consolidated financial statements which are included in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on March 5, 2024. The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the consolidated financial statements and the accompanying notes to those financial statements.
Revenue, expenses, assets, and liabilities can vary during each quarter of the year. The results and trends in these interim Condensed Consolidated Financial Statements are not necessarily indicative of the results to be expected for the full year or any other period.
Use of Estimates
The preparation of consolidated financial statements in conformity with U.S. generally accepted accounting principles (GAAP) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenue and expenses during the reporting period. Accounting estimates and assumptions are inherently uncertain.
Actual results could differ materially from those estimates and assumptions. As appropriate, we assess estimates each period, update them to reflect current information, and generally reflect any changes in estimates in the period first identified.
Significant Concentrations
Our customers are primarily pharmaceutical companies that are located in the U.S. and Europe and with whom we have multi-year arrangements. Our accounts receivable balances contain billed and unbilled trade receivables from product sales, milestones (to the extent that they have been achieved and are due from the counterparty), and other contingent payments, as well as reimbursable costs from collaborative research and development agreements. We generally do not require collateral from our customers. We perform a regular review of our customers’ credit risk and payment histories, including payments made after period end. Historically, we havenot experienced credit losses from our accounts receivable or contract assets. We have not recorded reserves for credit losses for thethree and nine months ended September 30, 2024 and 2023, nor have recorded such an allowance as of September 30, 2024 or December 31, 2023. As of September 30, 2024, all billed and unbilled trade receivables from product sales and contract assets have been classified as held-for-sale and included within assets held for sale on our Condensed Consolidated Balance Sheets.
We are dependent on our suppliers and contract manufacturers to provide raw materials and drugs of appropriate quality and reliability and to meet applicable contract and regulatory requirements. In certain cases, we rely on single sources of supply of one or more critical materials. Consequently, in the event that supplies are delayed or interrupted for any reason, our ability to develop and produce our drug candidates or our ability to meet our supply obligations could be significantly impaired, which could have a material adverse effect on our business, financial condition and results of operations.
For our available-for-sale securities, we have significant concentrations of issuers in the banking and financial services industries. While our investment policy requires that we only invest in highly-rated securities and limit our exposure to any single issuer, various factors may materially affect the financial condition of issuers. Additionally, pursuant to our investment policy, we may sell securities before maturity if the issuer’s credit rating has been downgraded below our minimum credit rating requirements, which may result in a loss on the sale. Accordingly, if various factors result in downgrades below our minimum credit rating requirements and if we decide to sell these securities, we may experience losses on such sales.
Treasury Stock
We record treasury stock activities under the cost method. Treasury stock is included in authorized and issued shares but excluded from outstanding shares. The re-issuance of treasury stock is accounted for on a first in, first-out basis and any differences between the cost of treasury stock and the re-issuance proceeds are charged or credited to additional paid-in capital.
Restructuring
We recognize restructuring charges related to reorganization plans that have been committed to by management when liabilities have been incurred. In connection with these activities, we record restructuring charges at fair value for:
contractual or other employee termination benefits provided that the obligations result from services already rendered based on rights that vest or accumulated when the payment of benefits becomes probable and the amount can be reasonably estimated;
one-time employee termination benefits on the communication date from management to the employees provided that management has committed to a plan of termination, the plan identifies the employees and their expected termination dates, the details of termination benefits are complete, and it is unlikely that changes to the plan will be made or the plan will be withdrawn; and
contract termination costs for costs incurred when we cancel the contract in accordance with its terms, or for costs to be incurred over the remaining contract term without economic benefit to us at the cease-use date.
For one-time employee terminations benefits, we recognize the liability in full on the communication date when future services are not required or amortize the liability ratably over the service period, if required. The fair value of termination benefits reflects our estimates of expected utilization of certain Company-funded post-employment benefits.
See Note 7 for additional information on the severance expense that we recognized for employees terminated in connection with our reductions-in-force.
Impairment of Goodwill
Goodwill is assessed for impairment on an annual basis and whenever events and circumstances indicate that it may be impaired. Factors that may indicate potential impairment and trigger an impairment test include, but are not limited to, current economic, market and geopolitical conditions, including a significant, sustained decline in our stock price and market capitalization compared to the net book value; an adverse change in legal factors, business climate or operational performance of the business; or significant changes in the ability of the reporting unit to generate positive cash flows for our strategic business objectives. If the carrying value of the reporting unit, including goodwill, exceeds the reporting unit’s fair value, we will recognize a goodwill impairment loss, and we will write down goodwill such that the carrying value of the reporting unit equals its fair value, provided that we cannot reduce goodwill below zero.
See Note 8 for additional information regarding the impairment charges we recorded during the three months ended March 31, 2023 in connection with our goodwill.
Long-Lived Asset Impairment
We assess the impairment of long-lived assets whenever events or changes in business circumstances indicate that the carrying amounts of the assets may not be fully recoverable. In the case of property, plant and equipment and right-of-use assets for our leases, we determine whether there has been an impairment by comparing the carrying value of the asset to the anticipated undiscounted net cash flows associated with the asset. If such cash flows are less than the carrying value, we write down the asset to its fair value, which may be measured as anticipated net cash flows associated with the asset, discounted at a rate that we believe a market participant would utilize to reflect the risks associated with the cash flows, such as credit risk.
See Note 7 for additional information regarding the impairment charges we recorded in connection with our leased facilities and certain property and equipment.
Net Loss per Share
For all periods presented in the Condensed Consolidated Statements of Operations, the net loss available to common stockholders is equal to the reported net loss. We calculate basic net loss per share based on the weighted-average number of common shares outstanding, including the pre-funded warrant, during the periods presented. Shares of common stock into which the pre-funded warrant may be exercised are considered outstanding for the purposes of computing basic net loss per share because the shares may be issued for little or no consideration, are fully vested and are exercisable after the original issuance date. For the three and nine months ended September 30, 2024 and 2023, basic and diluted net loss per share are the same due to our net losses and the requirement to exclude potentially dilutive securities which would have an antidilutive effect on net loss per share. We excluded shares underlying the weighted average outstanding stock options, restricted stock units (RSUs) and performance stock units (PSUs), as follows (in thousands):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Potentially dilutive securities | 25,887 | 17,476 | 26,417 | 20,513 |
Note 2 — Cash and Investments in Marketable Securities
Cash and investments in marketable securities, including cash equivalents, are as follows (in thousands):
| Estimated Fair Value at | ||
|---|---|---|
| September 30, 2024 | December 31, 2023 | |
| Cash and cash equivalents | $30,109 | $35,277 |
| Short-term investments | 214,386 | 268,339 |
| Long-term investments | 4,537 | 25,825 |
| Total cash, cash equivalents, and investments in marketable securities | $249,032 | $329,441 |
Our portfolio of cash and investments in marketable securities includes (in thousands):
| September 30, 2024 · December 31, 2023 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Fair Value Hierarchy Level · Amortized Cost · Gross Unrealized Gains · Gross Unrealized Losses · Fair Value · Fair Value | |||||||||
| Corporate notes and bonds | 2 | $90,589 | $214 | $(10) | $90,793 | $38,882 | |||
| Corporate commercial paper | 2 | 125,927 | 163 | (7) | 126,083 | 255,241 | |||
| Obligations of U.S. government agencies | 2 | 1,500 | 2 | — | 1,502 | — | |||
| Available-for-sale investments | $218,016 | $379 | $(17) | $218,378 | $294,123 | ||||
| Money market funds | 1 | 10,361 | 2,359 | ||||||
| Certificates of deposit | 2 | 14,046 | 15,116 | ||||||
| Cash | N/A | 6,247 | 17,843 | ||||||
| Total cash and investments in marketable securities | $249,032 | $329,441 | |||||||
For the three and nine months ended September 30, 2024 and 2023, there were no transfers between Level 1 and Level 2 of the fair value hierarchy. At December 31, 2023, our gross unrealized gains and losses were insignificant.
Note 3 — Condensed Consolidated Financial Statement Details
Inventory
Inventory consists of the following (in thousands):
| September 30, 2024 | December 31, 2023 | |
|---|---|---|
| Raw materials | $— | $1,861 |
| Work-in-process | — | 12,880 |
| Finished goods | — | 1,360 |
| Total inventory, net | $— | $16,101 |
We manufacture finished goods inventory upon receipt of firm purchase orders, and we may manufacture certain intermediate work-in-process materials and purchase raw materials based on purchase forecasts from our partners. We include direct materials, direct labor, and manufacturing overhead in inventory and determine cost on a first-in, first-out basis for raw materials and on a specific identification basis for work-in-process and finished goods. We value inventory at the lower of cost or net realizable value, and we write down defective or excess inventory to net realizable value based on historical experience or projected usage. We expense inventory related to our research and development activities as manufactured by us or when purchased.
As of September 30, 2024 and December 31, 2023, we recorded aggregate provisions of $0 and $2.0 million, respectively, for the net realizable value of our batches. Our manufacturing agreement with UCB Pharma (UCB) for the reagent used in the manufacture of CIMZIA® provided for a fixed selling price which we had negotiated in exchange for a higher royalty rate.
Accordingly, when evaluating the net realizable value of our inventory for UCB, we include the negotiated increase of the royalties in our analysis, and the aggregate revenue has historically been greater than our manufacturing cost. Due to the decreases in the royalty rate for 2024 and 2025 as a result of a settlement agreement with UCB, the aggregate revenue was expected to be less than our manufacturing cost for these years, and therefore we previously recorded a provision for net realizable value. As further disclosed in Note 6, on July 31, 2024, we entered into a long-term supply agreement with UCB that increases the selling price of the reagent used in the manufacture of CIMZIA®, which resulted inthe aggregate revenue exceeding our manufacturing costs. As a result, we reduced the provision to $0 during thethree months ended September 30, 2024.
As of September 30, 2024, all of the inventory balance is classified as held for sale and included within assets held for sale on our Condensed Consolidated Balance Sheets.
Other Current Assets
Other current assets consist of the following (in thousands):
| September 30, 2024 | December 31, 2023 | |
|---|---|---|
| Prepaid research and development expenses | $3,960 | $4,325 |
| Interest and other non-trade receivables | 2,123 | 1,047 |
| Other prepaid expenses | 2,850 | 4,407 |
| Total other current assets | $8,933 | $9,779 |
Assets Held for Sale
We classify assets and liabilities (the “disposal group”) as held for sale in the period in which all of the required criteria under ASC 360 “Property, Plant, and Equipment” are met. We initially measure the disposal group asset that is classified as held for sale at the lower of its carrying value or fair value less any costs to sell. Upon classification of the disposal group, we test the assets for impairment and cease related depreciation and amortization.
As of September 30, 2024, we concluded that our manufacturing facility in Huntsville, Alabama meets the requirements for classification as assets held for sale. Accordingly, assets and liabilities associated with the disposal group were reclassified as held for sale. See Note 10 for additional information. The assets and liabilities as of December 31, 2023 on our Condensed Consolidated Balance Sheets were not recast to reflect the held for sale classification.
As of September 30, 2024, assets held for sale consist of the following:
| Accounts receivable | $1,746 |
|---|---|
| Inventory, net | 16,889 |
| Property, plant and equipment, net | 11,386 |
| Contract asset | 3,032 |
| Total assets held for sale | $33,053 |
A contract asset is a right to consideration that is conditional upon factors other than the passage of time. The contract asset above relates to the long-term supply agreement with UCB entered into on July 31, 2024 (See Note 6 for additional information). As of September 30, 2024, liabilities related to assets held for sale primarily consists of accrued compensation and other accrued expenses.
Property, Plant and Equipment
Property, plant and equipment consists of the following (in thousands):
| September 30, 2024 | December 31, 2023 | |
|---|---|---|
| Building and leasehold improvements | $3,834 | $43,184 |
| Computer equipment and computer software | 14,615 | 22,438 |
| Manufacturing equipment | — | 24,315 |
| Laboratory equipment | 616 | 14,537 |
| Furniture, fixtures and other | 59 | 541 |
| Depreciable property, plant and equipment at cost | 19,124 | 105,015 |
| Less: accumulated depreciation | (15,659) | (86,898) |
| Depreciable property, plant and equipment, net | 3,465 | 18,117 |
| Construction in process | 138 | 739 |
| Property, plant and equipment, net | $3,603 | $18,856 |
Due to the weakening lease markets during the three months ended June 30, 2024, we recorded additional non-cash impairment charges of $1.0 million for property, plant and equipment for the three months ended June 30, 2024, which we report in restructuring, impairment and costs of terminated program in our Condensed Consolidated Statement of Operations. See Note 7 for additional information. As of September 30, 2024, property, plant and equipment associated with our manufacturing facility in Huntsville, Alabama is classified as held for sale and included within assets held for sale on our Condensed Consolidated Balance Sheets.
Accrued Expenses
Accrued expenses consist of the following (in thousands):
| September 30, 2024 | December 31, 2023 | |
|---|---|---|
| Accrued compensation | $7,007 | $5,553 |
| Accrued research and development expenses | 17,916 | 10,118 |
| Accrued contract termination costs | 3,151 | 3,020 |
| Other accrued expenses | 4,303 | 3,471 |
| Total accrued expenses | $32,377 | $22,162 |
Liabilities Related to the Sales of Future Royalties
In 2012 and 2020, we sold to RPI Finance Trust (RPI) and HCR, respectively, our rights to receive royalties under our license and manufacturing agreements with certain pharmaceutical partners under the 2012 Purchase and Sale Agreement and the 2020 Purchase and Sale Agreement, respectively. We account for these transactions as debt and recognize non-cash royalty revenue and non-cash interest expense to amortize the proceeds over the lives of the respective arrangements. We periodically update our prospective non-cash interest rate based on our estimates of future royalties. As of September 30, 2024, our imputed interest rates for the arrangements with RPI and HCR were 43% and 24%, respectively.
The original 2020 Purchase and Sale Agreement was to expire -- and wherein the right to receive royalties would revert to us -- if HCR received aggregate royalties of $210.0 million on or prior to December 31, 2025 (the 2025 Threshold), or, if the 2025 Threshold was not achieved by December 31, 2025, when HCR received aggregate royalties of $240.0 million. On March 4, 2024, Nektar and HCR amended the original 2020 Purchase and Sale Agreement (the Amendment), pursuant to which the parties agreed to remove our reversionary rights in the royalties in exchange for a $15.0 million payment from HCR. Accordingly, HCR will receive all future royalties of the products, and none of these royalties will return to Nektar. We account for the Amendment as a modification of the existing arrangement, and therefore recorded the $15.0 million proceeds as an increase to the liability.
The following is a reconciliation of the changes in our liabilities related to the sales of future royalties for thenine months ended September 30, 2024 (in thousands):
| 2012 Purchase and Sale Agreement | 2020 Purchase and Sale Agreement | Total | |
|---|---|---|---|
| Liabilities related to the sales of future royalties, net – beginning balance | $24,217 | $88,408 | $112,625 |
| Non-cash royalty revenue | (19,007) | (29,022) | (48,029) |
| Non-cash interest expense | 4,940 | 13,019 | 17,959 |
| Amortization of transaction costs | — | 274 | 274 |
| Proceeds from the Amendment | — | 15,000 | 15,000 |
| Liabilities related to the sales of future royalties, net – ending balance | $10,150 | $87,679 | $97,829 |
Accumulated Other Comprehensive Income (Loss)
The following table summarizes the changes in accumulated other comprehensive income (loss) by component (in thousands):
| Foreign currency translation | Available-for-sale securities | Accumulated Other Comprehensive Income | |
|---|---|---|---|
| Balance at December 31, 2023 | $30 | $50 | $80 |
| Foreign currency translation adjustments | (8) | — | (8) |
| Unrealized gain (loss) on available-for-sale securities | — | (475) | (475) |
| Balance at March 31, 2024 | $22 | $(425) | $(403) |
| Foreign currency translation adjustments | (1) | — | (1) |
| Unrealized gain (loss) on available-for-sale securities | — | (90) | (90) |
| Balance at June 30, 2024 | $21 | $(515) | $(494) |
| Foreign currency translation adjustments | (28) | — | (28) |
| Unrealized gain (loss) on available-for-sale securities | — | 877 | 877 |
| Balance at September 30, 2024 | $(7) | $362 | $355 |
| Foreign currency translation | Available-for-sale securities | Accumulated Other Comprehensive Income | |
|---|---|---|---|
| Balance at December 31, 2022 | $(5,131) | $(1,776) | $(6,907) |
| Foreign currency translation adjustments | 139 | — | 139 |
| Unrealized gain (loss) on available-for-sale securities | — | 1,087 | 1,087 |
| Balance at March 31, 2023 | $(4,992) | $(689) | $(5,681) |
| Foreign currency translation adjustments | 13 | — | 13 |
| Unrealized gain (loss) on available-for-sale securities | — | 244 | 244 |
| Reclassification adjustments to income | (1,026) | — | (1,026) |
| Balance at June 30, 2023 | $(6,005) | $(445) | $(6,450) |
| Foreign currency translation adjustments | (98) | — | (98) |
| Unrealized gain (loss) on available-for-sale securities | — | 196 | 196 |
| Balance at September 30, 2023 | $(6,103) | $(249) | $(6,352) |
The reclassification from accumulated other comprehensive loss relates to the closure of one of our foreign subsidiaries and has been included within other income (expense), net in our Condensed Consolidated Statement of Operations.
Note 4 — Commitments and Contingencies
Legal Matters
From time to time, we are involved in lawsuits, arbitrations, claims, investigations and proceedings, consisting of intellectual property, commercial, employment and other matters, which arise in the ordinary course of business. We make provisions for liabilities when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. Such provisions are reviewed at each reporting date and adjusted to reflect the impact of settlement negotiations, judicial and administrative rulings, advice of legal counsel, and other information and events pertaining to a particular case. Litigation is inherently unpredictable. If any unfavorable ruling were to occur in any specific period, there exists the possibility of a material adverse impact on the results of our operations for that period and on our cash flows and liquidity.
On August 7, 2023, we filed a complaint in the United States District Court for the Northern District of California (the Court) against Lilly alleging, among other claims, breach of contract and breach of implied covenant of good faith and fair dealing (the Complaint), in connection with our collaboration with Lilly. Following the denial of its motion to dismiss the Complaint entirely, Lilly filed an answer that included counterclaims against us alleging breach of specified confidentiality provisions and defamation. The case is proceeding.
We have recordedno liability for any litigation matters in our Condensed Consolidated Balance Sheets at either September 30, 2024 or December 31, 2023.
Indemnifications in Connection with Commercial Agreements
As part of our collaboration agreements with our partners related to the license, development, manufacture and supply of drugs and PEGylation materials based on our proprietary technologies and drug candidates, we generally agree to defend, indemnify and hold harmless our partners from and against third party liabilities arising out of the agreement, including product liability (with respect to our activities) and infringement of intellectual property to the extent the intellectual property is developed by us and licensed to our partners. The term of these indemnification obligations is generally perpetual commencing after execution of the agreement. There is generally no limitation on the potential amount of future payments we could be required to make under these indemnification obligations.
From time to time, we enter into other strategic agreements such as divestitures and financing transactions pursuant to which we are required to make representations and warranties and undertake to perform or comply with certain covenants. For example, we made certain intellectual property representations in connection with our RPI and HCR transactions, however, the time limitation we have to indemnify RPI with respect to any breach of these intellectual property-based representations and warranties has passed. In the event it is determined that we breached certain of the representations and warranties or covenants made by us in any such agreements or certain express indemnification provisions are applicable, we could incur substantial indemnification liabilities depending on the timing, nature, and amount of any such claims.
To date, we have not incurred any costs to defend lawsuits or settle claims related to these indemnification obligations, nor any breaches of representations or warranties or covenants. Because the aggregate amount of any potential indemnification obligation is not a stated amount, we cannot reasonably estimate the overall maximum amount of any such obligations.
Note 5 — Pre-Funded Warrant
In March 2024, we issued a pre-funded warrant to purchase an aggregate of 25,000,000 shares of our common stock to TCG at a price of $1.20 per share for gross proceeds of $30.0 million. Transaction costs were immaterial. The pre-funded warrant has an exercise price of $0.0001 per share and may be exercised at any time after the original issuance date. TCG may not exercise the warrant if TCG, together with its affiliates, would beneficially own more than 9.99% of the number of shares of our common stock outstanding immediately after giving effect to such exercise. TCG may increase or decrease this percentage not in excess of 19.99% by providing at least 61 days’ prior notice to the Company. On May 28, 2024, we filed with the SEC a registration statement on Form S-3 (file no. 333-279760) registering for resale of up to 25,000,000 sharesof our common stock issuable upon exercise of the pre-funded warrant. The registration statement became effective on June 5, 2024. As of September 30, 2024, the warrant has not been exercised.
We classified the pre-funded warrant as a component of permanent equity in our Condensed Consolidated Balance Sheets as it is a freestanding financial instrument that was immediately exercisable, does not embody an obligation for the Company to repurchase its own shares and permits the holder to receive a fixed number of shares of common stock upon exercise. All of the shares underlying the pre-funded warrant have been included in the weighted-average number of shares of common stock used to calculate net loss per share attributable to common stockholders because the shares may be issued for little or no consideration, are fully vested and are exercisable after the original issuance date of the pre-funded warrant.
Note 6 — License and Collaboration Agreements
We have entered into various collaboration agreements including license agreements and collaborative research, development and commercialization agreements with various pharmaceutical and biotechnology companies. Under these collaboration arrangements, we are entitled to receive license fees, upfront payments, milestone and other contingent payments, royalties, sales milestone payments, and payments for the manufacture and supply of our proprietary polyethylene glycol reagents (PEG reagents) and/or reimbursement for research and development activities. We generally include our costs of performing these services in research and development expense, except for costs for product sales to our collaboration partners which we include in cost of goods sold. We analyze our agreements to determine whether we should account for the agreements within the scope of ASC 808 Collaborative Arrangements, and, if so, we analyze whether we should account for any elements under ASC 606 Revenue from Contracts with Customers.
Eli Lilly and Company (Lilly): Rezpegaldesleukin (previously referred to as NKTR-358)
On July 23, 2017, we entered into a worldwide license agreement (the Lilly Agreement) with Lilly to co-develop rezpegaldesleukin, a novel immunological drug candidate that we invented, pursuant to which we received an initial payment of $150.0 million and were eligible for up to $250.0 million in additional development and regulatory milestones. The Lilly Agreement provided that, during Phase 1B and Phase 2 development, we shared development costs wherein 75% of the costs were borne by Lilly and 25% of the costs were borne by us.
On April 23, 2023, we received from Lilly a notice of at-will termination of the Lilly Agreement. We have regained full rights to rezpegaldesleukin from Lilly, and the Lilly Agreement subsequently terminated. Following the return of our rights to develop rezpegaldesleukin, we bear all costs of development. We initiated a Phase 2b study of rezpegaldesleukin in patients with moderate-to-severe atopic dermatitis in October 2023 and a Phase 2b study of rezpegaldesleukin in patients with severe-to-very severe alopecia areata in March 2024. We will also explore other auto-immune indications for the development of rezpegaldesleukin.
Bristol-Myers Squibb Company (BMS): Bempegaldesleukin, also referred to as NKTR-214
Effective April 3, 2018, we entered into a Strategic Collaboration Agreement (the BMS Collaboration Agreement) and a Share Purchase Agreement with BMS. Pursuant to the BMS Collaboration Agreement, we and BMS jointly developed bempegaldesleukin in combination with BMS’ Opdivo®. The parties shared the internal and external development costs for bempegaldesleukin in combination regimens based on each party’s relative ownership interest in the compounds included in the regimens.
Upon the effective date of the BMS Collaboration Agreement in April 2018, BMS paid us a non-refundable upfront cash payment of $1.0 billion and purchased 8,284,600 shares of our common stock pursuant to the Share Purchase Agreement for total additional cash consideration of $850.0 million. In 2020, we received additional non-refundable milestone payments of $50.0 million.
In April 2022, we announced that BMS and we decided to discontinue all development of bempegaldesleukin in combination with Opdivo®. On September 6, 2023, BMS and we terminated the BMS Collaboration Agreement, and pursuant to the surviving provisions of the BMS Collaboration Agreement, we and BMS continue our efforts to wind down the bempegaldesleukin program, and the cost sharing provisions continue to remain in effect as the parties wind down the studies. On February 12, 2024, we repurchased the 8.3 million shares previously sold to BMS for total cash consideration of $3.0 million.
We determined that the BMS Collaboration Agreement falls within the scope of ASC 808. Based on the cost sharing percentages described above, we recognize the net reimbursement to (from) BMS as an increase (decrease) to the applicable expense. As discussed in Note 7, beginning in the second quarter of 2022, we began reporting clinical trial, other third-party costs and employee costs for the wind down of the bempegaldesleukin program in restructuring, impairment and costs of terminated program. For the three and nine months ended September 30, 2024, such amounts are immaterial and are included in research and development expense.
Biolojic Design (Biolojic): NKTR-0165
In 2021, we entered into a research collaboration and license option agreement with Biolojic to discover and develop agonistic antibodies that activate a novel and previously un-drugged target for the treatment of autoimmune diseases. In 2023, we exercised an option to gain an exclusive license to specified agonistic antibodies and other materials that were developed pursuant to a research collaboration and license option agreement in all fields of use (other than in the field of oncology). As a result of exercising the option to gain an exclusive license, we may be required to pay up to $18.0 million based on the achievement of certain development milestones, including the first milestone of $3.0 million payable upon the acceptance of the first investigational new drug application, and up to $35.0 million based on the achievement of certain regulatory approval milestones. Each milestone is payable only once, regardless of the number of indications for which we develop the licensed product. We record a liability when a milestone payment becomes probable. As of September 30, 2024, no milestones have been achieved or are considered probable, and no liability has been recorded.
Other
We have other collaboration agreements that have resulted in commercialized products for our collaborations partners. Under these agreements, we may sell our proprietary PEG reagents for use in these products, and we are entitled to receive royalties based on net sales of these products as well as sales milestones. As discussed in Note 3, we have sold our rights to receive royalties from these other collaboration agreements. Our non-cash royalty revenue, which totaled$18.2 million and$50.9 million for the three and nine months ended September 30, 2023, respectively, and$15.7 million and$48.0 million for the three and nine months ended September 30, 2024, respectively, represents revenue for granting licenses which we had satisfied in prior periods.
We have a collaboration agreement with UCB for dapirolizumab pegol, under which we are entitled to up to a total of $40.0 million of regulatory approval milestones, as well as royalties in the low single digits based on net sales of commercialized products, if any. UCB is developing dapirolizumab pegol, a PEGylated antibody fragment, with Biogen, Inc. for the treatment of systemic lupus erythematosus. However, given the current phase of development of this product and the uncertainty in clinical development, we have excluded these milestones from the transaction price for this agreement. We have not sold our rights to receive these milestones or royalties from dapoirolizumab pegol under the APA with the Purchaser of the sale of the Facility.
On July 31, 2024, and further formalized in an Amended and Restated Manufacturing and Supply Agreement dated October 18, 2024, we entered into a long-term "take or pay" supply agreement with UCB that increases the selling price of the PEG reagent used in the manufacture of CIMZIA® (the UCB Supply Agreement). The UCB Supply Agreement also covers UCB’s purchases of the same reagent (at the same price) for use in the manufacture of dapirolizumab pegol. We analyzed the terms of the agreement, including its cancellation provisions, and concluded that it represents a long-term agreement. Since the performance obligations are deliveries of a single reagent, we determined a single sales price for recognition of revenue over the term of the arrangement. Accordingly, because the billed price was less than the single selling price, we recorded a contract asset of $3.0 millionas of September 30, 2024, which is included within assets held for sale on our Condensed Consolidated Balance Sheet, as further disclosed in Note 3. Pursuant to a separate APA between the Purchaser and us, the UCB Supply Agreement will be assigned to the Purchaser upon closing of the sale of the Facility. The assignment of the UCB Supply Agreement does not alter the potential milestones and potential royalties payable by UCB to us pursuant to the collaboration agreement for dapirolizumab pegolnor the non-cash royalties payable under our collaboration agreement for CIMZIA®. See Note 10 for additional information on the APA.
Note 7 — Restructuring, Impairment and Costs of Terminated Program
In connection with our 2022 and 2023 Restructuring Plans, we report the following costs in restructuring, impairment and costs of terminated program:
Clinical trial expense, other third-party costs and employee costs for the wind down of the bempegaldesleukin program, net of the reimbursement from BMS, initiated in 2022;
Severance and related benefit costs pursuant to the 2022 and 2023 Restructuring Plans;
Non-cash impairment of right-of-use assets and property, plant and equipment; and
Contract termination and other costs associated with these plans.
Restructuring, impairment and costs of terminated program includes the following (in thousands):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Clinical trial expense, other third-party and employee costs for the wind down of the bempegaldesleukin program | $— | $652 | $— | $3,606 |
| Severance and benefit expense | — | 535 | — | 7,961 |
| Impairment of right-of-use assets and property, plant and equipment | — | 10,173 | 8,329 | 36,628 |
| Contract termination and other restructuring costs | 46 | — | 5,981 | 912 |
| Restructuring, impairment and other costs of terminated program | $46 | $11,360 | $14,310 | $49,107 |
Wind Down of the Bempegaldesleukin Program
In prior periods through March 31, 2022, we reported the clinical trial costs, other third-party costs and employee costs related to the bempegaldesleukin program primarily in research and development expense. Beginning in the second quarter of 2022, following our announcement to terminate the program, we began reporting clinical trial, other third-party costs and employee costs for the wind down of the bempegaldesleukin program in restructuring, impairment and costs of terminated program. For the three and nine months ended September 30, 2024, such amounts are immaterial and are included in research and development expense.
Severance and Benefit Expense
Employees affected by the reduction in force under the 2022 and 2023 Restructuring Plans are entitled to receive severance payments and certain Company funded benefits. The restructuring charges are recorded at fair value.
For the 2022 Restructuring Plan, we recognized all expense in 2022 and paid the final liability of $3.3 million in the three months ended March 31, 2023.
For the 2023 Restructuring Plan, we recognized $7.9 million in total expense in 2023 for the 2023 Restructuring Plan and paid the final liability of $0.2 million in the three months ended March 31, 2024.
We do not expect to recognize any additional severance and benefits expense for the 2022 and 2023 Restructuring Plans.
The following table provides details regarding the severance and benefit expense for thethree and nine months ended September 30, 2024 pursuant to the 2023 Restructuring Plan and a reconciliation of the severance and benefits liability for the three and nine months ended September 30, 2023 pursuant to the 2022 and 2023 Restructuring Plans, which we report within accrued expenses on our Condensed Consolidated Balance Sheet (in thousands):
| 2023 Restructuring Plan | 2022 Restructuring Plan | Total | |
|---|---|---|---|
| Liability balance as of December 31, 2022 | $— | $3,299 | $3,299 |
| Expense recognized during the period | 5,483 | — | 5,483 |
| Payments during the period | — | (3,299) | (3,299) |
| Liability balance as of March 31, 2023 | $5,483 | $— | $5,483 |
| Expense recognized during the period | 1,943 | — | 1,943 |
| Payments during the period | (6,624) | — | (6,624) |
| Liability balance as of June 30, 2023 | $802 | $— | $802 |
| Expense recognized during the period | 535 | — | 535 |
| Payments during the period | (887) | — | (887) |
| Liability balance as of September 30, 2023 | $450 | $— | $450 |
| 2023 Restructuring Plan | 2022 Restructuring Plan | Total | |
| Liability balance as of December 31, 2023 | $196 | $— | $196 |
| Expense recognized during the period | — | — | — |
| Payments during the period | (196) | — | (196) |
| Liability balance as of September 30, 2024 | $— | $— | $— |
Impairment of Long-Lived Assets
As a result of our 2022 and 2023 Restructuring Plans, we decided to seek a sublease for all of our leased spaces on Third Street and Mission Bay Blvd. South (the Third Street Facility and the Mission Bay Facility, respectively). Accordingly, we evaluate each space for impairment when management decides to sublease the respective space and at each reporting date thereafter, as facts and circumstances change. The significant assumptions in our impairment analysis relate to sublease income, including the length of time to enter into a sublease, sublease rental payments, free rent periods, tenant improvement allowances and broker commissions. When available, we use sublease negotiations or agreements, but in the absence of such information, we develop our own subjective estimates based on current real estate trends and market conditions. Accordingly, our estimates are subject to significant risk, and the terms of sublease agreements, if any, and the resulting amount and timing of sublease income, if ever realized, may be materially different than our estimates.
As part of our evaluation of each sublease space, we separately compare the estimated undiscounted sublease income, as described above, for each sublease to the net book value of the related long-term assets, which include right-of-use assets and certain property, plant and equipment, primarily for leasehold improvements (collectively, sublease assets). If such sublease income exceeds the net book value of the sublease assets, we do not record an impairment charge. Otherwise, we record an impairment charge by reducing the net book value of the sublease assets to their estimated fair value, which we determined by discounting the estimated sublease income using the estimated borrowing rate of a market participant subtenant.
During the three months ended March 31, 2023, we recorded an initial impairment charge of $11.5 million for our remaining office and laboratory leased space in our Mission Bay Facility, when we initially decided to sublease the space under the 2023 Restructuring Plan. We also recorded an additional impairment charge of $1.7 million for certain excess laboratory equipment which we subsequently sold in the three months ended September 30, 2023 and recognized an immaterial gain, resulting in a net impairment of $1.3 million for the nine months ended September 30, 2023. As the life sciences lease market has continued to deteriorate in the San Francisco Bay Area, we recorded additional non-cash impairment charges of $9.1 million in the three months ended September 30, 2023, and $3.9 million in the three months ended June 30, 2024, for this space.
During the three months ended June 30, 2023 and September 30, 2023, we recorded additional non-cash impairment charges of $7.1 million and $1.5 million, respectively, for other sublease assets in our Mission Bay Facility that we sought to sublease under the 2022 Restructuring Plan. Due to the worsening office lease market, for the three months ended June 30, 2024 and 2023, we recorded non-cash impairment charges of $4.4 million and $6.2 million, respectively, for our sublease assets at our Third Street Facility.
For these impairment charges, we developed our estimates of sublease income based on market participant assumptions as described above, and we discounted the sublease income using the estimated borrowing rate of a market participant subtenant, which we estimated to be 7.9% for the three months ended March 31, 2023,8.5% for the three months ended June 30, 2023,8.7% for the three months ended September 30, 2023, and 6.2% for the three months ended June 30, 2024. We recordedno impairment charges for the three months ended March 31, 2024 and the three months ended September 30, 2024.
The following is a reconciliation of the impairment charges we recorded for thenine months ended September 30, 2024 and three and nine months ended September 30, 2023, including the net book values of the sublease assets before the impairment and the fair values of the sublease assets (in thousands):
| Property, Plant and Equipment | Operating Lease Right-of-Use Assets | Total | |
|---|---|---|---|
| Net book value of impaired facilities before write-off | $1,897 | $12,506 | $14,403 |
| Less: Fair value of impaired facilities — Level 3 of Fair Value Hierarchy | (855) | (5,219) | (6,074) |
| Total impairment of right-of-use assets and property, plant and equipment | $1,042 | $7,287 | $8,329 |
| Property, Plant and Equipment | Operating Lease Right-of-Use Assets | Total | |
|---|---|---|---|
| Net book value of impaired facilities before write-off | $3,050 | $18,830 | $21,880 |
| Less: Fair value of impaired facilities — Level 3 of Fair Value Hierarchy | (1,650) | (9,663) | (11,313) |
| Impairment expense for facilities | 1,400 | 9,167 | 10,567 |
| (Gain) on sale or disposal of property, plant, and equipment | (394) | — | (394) |
| Total impairment of right-of-use assets and property, plant and equipment | $1,006 | $9,167 | $10,173 |
| Property, Plant and Equipment · Operating Lease Right-of-Use Assets · Total | ||||
|---|---|---|---|---|
| Net book value of impaired facilities before write-off | $7,206 | $46,292 | $53,498 | |
| Less: Fair value of impaired facilities — Level 3 of Fair Value Hierarchy | (2,172) | (14,364) | (16,536) | |
| Book value in excess of fair value | 5,034 | 31,928 | 36,962 | |
| Less: Amounts recorded as amortization between March 31, 2023 and September 30, 2023 for Mission Bay facility | (263) | (1,370) | (1,633) | |
| Impairment expense for facilities | 4,771 | 30,558 | 35,329 | |
| Impairment of other property, plant and equipment | 1,299 | 1,299 | ||
| Total impairment of right-of-use assets and property, plant and equipment | $6,070 | $30,558 | $36,628 | |
Contract Termination and Other Costs
We have incurred significant contract termination costs in connection with our Restructuring Plans. Because we continue to adjust the liability based on updates to our assumptions at each reporting date, we continue to recognize expense as our estimates change until settlement.
The following are reconciliations of the contract termination and other costs forthree and nine months ended September 30, 2024 and 2023. As of September 30, 2024 and December 31, 2023, we report $3.2 million and $3.0 million, respectively, within accrued expenses and the remaining within other long-term liabilities on our Condensed Consolidated Balance Sheets.
| For the Nine Months Ended September 30, | ||
|---|---|---|
| 2024 | 2023 | |
| Liability balances as of December 31, 2023 and 2022, respectively | $5,542 | $7,710 |
| Expense recognized during the period | 975 | 912 |
| Payments during the period | (928) | (1,129) |
| Liability balances as of March 31, 2024 and 2023, respectively | $5,589 | $7,493 |
| Expense recognized during the period | 4,960 | - |
| Payments during the period | (887) | (1,264) |
| Liability balances as of June 30, 2024 and 2023, respectively | $9,662 | $6,229 |
| Expense recognized during the period | 46 | - |
| Payments during the period | (886) | (460) |
| Liability balances as of September 30, 2024 and 2023, respectively | $8,822 | $5,769 |
Note 8 — Impairment of Goodwill
During the three months ended March 31, 2023, our stock price and resulting market capitalization experienced a significant, sustained decline. Accordingly, we assessed our long-lived assets, including our property, plant and equipment, right-of-use assets and goodwill, for impairment.
As part of our long-lived asset impairment analysis, we first assessed which long-lived assets have identifiable cash flows that are largely independent of the cash flows of other groups of assets. We concluded that the sublease assets, for which we recognized significant impairment charges during 2022 and 2023, including for the three months ended March 31, 2023, are independent of our entity-wide group. See Note 7 for additional information regarding impairment charges that we have recorded for our sublease assets, as well as certain property, plant and equipment that we subsequently sold.
We next evaluated our remaining long-lived assets for impairment and performed a recoverability test using the undiscounted cash flows approach. We didnot recognize any additional impairment charges on the remaining long-lived assets.
Finally, we measured the fair value of our reporting unit utilizing both income and market approaches for our entity-wide asset impairment analysis. Based on this analysis, we wrote off all of our goodwill, resulting in a non-cash impairment charge of $76.5 million which we reported as impairment of goodwill in our Condensed Consolidated Statements of Operations for the three months ended March 31, 2023. We had previously recognized goodwill primarily from our acquisitions of Shearwater Corp. and Aerogen, Inc. in 2001 and 2005, respectively.
Note 9 — Stock-Based Compensation
We recognized total stock-based compensation expense in our Condensed Consolidated Statements of Operations as follows (in thousands):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Cost of goods sold | $516 | $841 | $1,673 | $2,454 |
| Research and development | 2,010 | 3,202 | 6,337 | 11,107 |
| General and administrative | 2,865 | 4,106 | 8,799 | 12,573 |
| Total stock-based compensation | $5,391 | $8,149 | $16,809 | $26,134 |
Note 10 — Subsequent Event
On November 1, 2024, we entered into the APA and certain other agreements (the Transactions) with an affiliate (the Purchaser) of Ampersand Capital Partners. Under the APA, the Purchaser will purchase our manufacturing facility located in
Huntsville, Alabama (the Facility), and certain other related assets and will assume certain related liabilities, and we will assign our manufacturing and supply agreements for PEG reagents to the Purchaser. As consideration, we will receive $70 million in cash at closing of the Transactions(subject to customary closing costs and adjustments based on closing net working capital, closing inventory and the amount of any indebtedness assumed by the Purchaser)and an approximate 20% equity ownership at the time of close in the Purchaser.
The closing of the Transactions is subject to the satisfaction or waiver of certain customary closing conditions set forth in the APA.
The APA contains customary representations and warranties of Nektar and Purchaser. Nektar has agreed to provide certain specific and customary indemnities to Purchaser for certain excluded liabilities not covered by a representation and warranties policy to be obtained by Purchaser in connection with the Transactions. In addition, the APA contains certain restrictive covenants, which will restrict, as of the closing of the Transactions, Nektar’s ability to manufacture and sell PEG reagents.
In addition, the APA provides that, at the closing of the Transactions, each of Nektar and Purchaser will enter into certain ancillary agreements to effect the Transactions, including a mutual transition services agreement and a manufacturing and supply agreement and for Purchaser to supply to Nektar the PEG reagents for use in the manufacture of rezpegaldesleukin and NKTR-255.
Item 2. Management’s Discussion and A
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.