IRONWOOD PHARMACEUTICALS INC
For the period ended Jun 30, 2024. Filed Aug 8, 2024.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2024 · Filed Aug 8, 2024
Extracted filing text, with the paragraph anchors used by the comparison.
See the whole filing, with its images and exhibitsContents
Notes to Condensed Consolidated Financial Statements
1. Nature of Business
Ironwood Pharmaceuticals, Inc. (“Ironwood” or the “Company”) is a gastrointestinal (“GI”) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. The Company is focused on the development and commercialization of innovative GI product opportunities in areas of significant unmet need, leveraging its demonstrated expertise and capabilities in GI diseases.
LINZESS® (linaclotide), the Company’s commercial product, is the first product approved by the United States Food and Drug Administration (the “U.S. FDA”) in a class of GI medicines called guanylate cyclase type C agonists (“GC-C agonists”) and is indicated for adult men and women suffering from irritable bowel syndrome with constipation (“IBS-C”) or chronic idiopathic constipation (“CIC”) and for pediatric patients ages 6-17 years-old suffering from functional constipation (“FC”). LINZESS is available to adult men and women suffering from IBS-C or CIC in the United States (the “U.S.”), Mexico and Saudi Arabia, adult men and women suffering from IBS-C or chronic constipation in Japan, and IBS-C in China, and pediatric patients ages 6-17 years old with FC in the U.S. Linaclotide is available under the trademarked name CONSTELLA® to adult men and women suffering from IBS-C or CIC in Canada, and to adult men and women suffering from IBS-C in certain European countries.
The Company has strategic partnerships with leading pharmaceutical companies to support the development and commercialization of linaclotide throughout the world. The Company and its partner, AbbVie Inc. (together with its affiliates, “AbbVie”), began commercializing LINZESS in the U.S. in December 2012. Under the Company’s collaboration for North America with AbbVie, total net sales of LINZESS in the U.S., as recorded by AbbVie, are reduced by commercial costs incurred by each party, and the resulting amount is shared equally between the Company and AbbVie. Additionally, development costs are shared equally between the Company and AbbVie.
Outside of the U.S., the Company earns royalties as a percentage of net sales of products containing linaclotide as an active ingredient by the Company’s collaboration partners. AbbVie has an exclusive license from the Company to develop and commercialize linaclotide in all countries other than China (including Hong Kong and Macau), Japan and the countries and territories of North America (the “AbbVie License Territory”). In addition, AbbVie has exclusive rights to commercialize linaclotide in Canada as CONSTELLA and in Mexico as LINZESS. Astellas Pharma Inc. (“Astellas”), the Company’s partner in Japan, has an exclusive license to develop, manufacture, and commercialize linaclotide in Japan. AstraZeneca AB (together with its affiliates) (“AstraZeneca”), the Company’s partner in China, has the exclusive right to develop, manufacture, and commercialize products containing linaclotide in China (including Hong Kong and Macau) (the “AstraZeneca License Territory”).
In June 2023, the Company completed a tender offer to purchase 98% of the outstanding ordinary shares of VectivBio Holding AG (“VectivBio”), a clinical-stage biotechnology company focused on the discovery and development of treatments for severe, rare GI conditions for which there is a significant unmet medical need, at a price per share of $17.00, net to the shareholders of VectivBio in cash, without interest and subject to any applicable withholding taxes (the “VectivBio Acquisition”). In December 2023, the Company completed a squeeze-out merger under Swiss law to acquire all remaining outstanding ordinary shares in cash at a price per share of $17.00, and VectivBio Holding AG was merged with and into Ironwood Pharmaceuticals GmbH, a wholly-owned subsidiary of Ironwood organized under the laws of Switzerland (the “Squeeze-out Merger”). Through the acquisition, the Company is advancing apraglutide, a next-generation, synthetic peptide analog of glucagon-like peptide-2, for rare GI diseases, including short bowel syndrome with intestinal failure (“SBS-IF”), a severe malabsorptive condition. In February 2024, the Company announced positive topline results from its pivotal Phase III clinical trial, STARS, which evaluated the efficacy and safety of once-weekly subcutaneous apraglutide in reducing parenteral support dependency in adult patients with SBS-IF, and plans to submit a new drug application and other regulatory filings for apraglutide for use in adult patients with SBS who are dependent on parenteral support.
The Company has a collaboration and license option agreement (the “COUR Collaboration Agreement”) with COUR Pharmaceutical Development Company, Inc. (“COUR”), a biotechnology company developing novel immune-
modifying nanoparticles to treat autoimmune diseases. The COUR Collaboration Agreement grants the Company an option (the “Option”) to acquire an exclusive license to research, develop, manufacture and commercialize, in the U.S., products containing CNP-104, a potential treatment for primary biliary cholangitis (“PBC”), a rare autoimmune disease targeting the liver.
These and other agreements are more fully described in Note 5,Collaboration, License and Other Agreements, to these condensed consolidated financial statements.
The Company is also advancing IW-3300, a GC-C agonist, for the potential treatment of visceral pain conditions, including interstitial cystitis / bladder pain syndrome and endometriosis.
The Company was incorporated in Delaware on January 5, 1998 as Microbia, Inc. On April 7, 2008, the Company changed its name to Ironwood Pharmaceuticals, Inc. To date, the Company has dedicated a majority of its activities to the research, development and commercialization of linaclotide, as well as to the research and development of its other product candidates.
2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying condensed consolidated financial statements and the related disclosures are unaudited and have been prepared in accordance with accounting principles generally accepted in the U.S. Additionally, certain information and footnote disclosures normally included in the Company’s annual financial statements have been condensed or omitted. Accordingly, these interim condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the Securities and Exchange Commission (“SEC”) on February 16, 2024 (the “2023 Annual Report on Form 10-K”).
The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements and, in the opinion of management, reflect all normal recurring adjustments considered necessary for a fair statement of the Company’s financial position as of June 30, 2024, and the results of its operations for the three and six months ended June 30, 2024 and 2023, its statements of stockholders’ equity (deficit) for the three and six months ended June 30, 2024 and 2023, and its cash flows for the six months ended June 30, 2024 and 2023. The results of operations for the three and six months ended June 30, 2024 and 2023 are not necessarily indicative of the results that may be expected for the full year or any other subsequent interim period.
Principles of Consolidation
The accompanying condensed consolidated financial statements as of June 30, 2024 include the accounts of Ironwood and its wholly-owned subsidiaries, Ironwood Pharmaceuticals Securities Corporation, Ironwood Pharmaceuticals GmbH, VectivBio AG, GlyPharma Therapeutic Inc. (“GlyPharma”), and VectivBio US, Inc. All intercompany transactions and balances are eliminated in consolidation.
For consolidated entities in which the Company owns less than 100% of the outstanding shares, the Company records net income (loss) and comprehensive income (loss) attributable to noncontrolling interests in its consolidated statements of income (loss) and comprehensive income (loss), respectively, equal to the percentage of the common stock ownership interest retained in such entities by the noncontrolling parties. The Company reports noncontrolling interests in consolidated entities as a component of equity separate from the Company’s equity.
Use of Estimates
The preparation of condensed consolidated financial statements in accordance with U.S. generally accepted accounting principles requires the Company’s management to make estimates and judgments that may affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the amounts of revenues and expenses during the reported periods. On an ongoing basis, the Company’s management evaluates its estimates, judgments and methodologies. Estimates and assumptions in the condensed consolidated financial statements include those related to fair value of assets acquired and liabilities assumed in acquisitions; revenue recognition; accounts receivable; useful lives of long-lived assets; impairment of long-
lived assets, including goodwill; valuation procedures for right-of-use assets and operating lease liabilities; income taxes, including uncertain tax positions and the valuation allowance for deferred tax assets; research and development expenses; contingencies; defined benefit pension liabilities; and share-based compensation. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ materially from these estimates under different assumptions or conditions. Changes in estimates are reflected in reported results in the period in which they become known.
Reclassifications
Certain prior period amounts have been reclassified to conform to current period presentation.
Summary of Significant Accounting Policies
The Company’s significant accounting policies are described in Note 2,* Summary of Significant Accounting Policies*, in the 2023 Annual Report on Form 10-K. During the three and six months ended June 30, 2024, the Company did not adopt any additional significant accounting policies.
New Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (the “FASB”) or other standard setting bodies that are adopted by the Company as of the specified effective date. The Company did not adopt any new accounting pronouncements during the three and six months ended June 30, 2024 that had a material effect on its condensed consolidated financial statements.
In October 2023, the FASB issued Accounting Standards Update (“ASU”) No. 2023-06,Disclosure Improvements: Codification Amendment in Response to the SEC’s Disclosure Update and Simplification Initiative(“ASU 2023-06”). The guidance in ASU 2023-06 aligns the disclosure and presentation requirements in the FASB Accounting Standards Codification with the SEC’s regulations. The effective date for each amendment will be the date on which the SEC's removal of the related disclosure requirement from Regulation S-X or Regulation S-K becomes effective, with early adoption prohibited. Any amendments not removed by the SEC by June 30, 2027 will not become effective. The amendments adopted in ASU 2023-06 will be applied prospectively. The Company is currently evaluating the impact that theadoption of ASU 2023-06 may have on its disclosures in its condensed consolidated financial statements.
In November 2023, the FASB issued ASU No. 2023-07,Segment Reporting (Topic 280)(“ASU 2023-07”)*.The guidance in ASU 2023-07 *expands prior reportable segment disclosure requirements by requiring entities to disclose significant segment expenses that are regularly provided to the Chief Operating Decision Maker (“CODM”) and details of how the CODM uses financial reporting to assess their segment’s performance. The guidance is effective for fiscal years beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The ASU is required to be applied retrospectively upon adoption. The Company is currently evaluating the impact that theadoption of ASU 2023-07 may have on its condensed consolidated financial statements.
In December 2023, the FASB issued ASU No. 2023-09,Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”). The guidance in ASU 2023-09 improves the transparency of annual income tax disclosures by requiring greater disaggregation of information in the rate reconciliation and income taxes paid disaggregated by jurisdiction. The standard is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. Upon adoption, ASU 2023-09 may be applied prospectively or retrospectively. The Company is currently evaluating the impact that theadoption of ASU 2023-09 may have on its disclosures in its annual consolidated financial statements.
Other recent accounting pronouncements issued, but not yet effective, are not expected to be applicable to the Company or have a material effect on the condensed consolidated financial statements upon future adoption.
3. Acquisitions
As described in Note 1,Nature of Business, on June 29, 2023, the Company completed the VectivBio Acquisition. The aggregate consideration paid by the Company to acquire the shares accepted for payment was approximately $1.2 billion. The Company financed the acquisition through proceeds from the borrowings under the Revolving Credit Agreement (as defined elsewhere below) and cash on hand.
The total purchase consideration for VectivBio is as follows (in thousands):
| | | |
|---|---|---|
| Cash consideration paid to selling shareholders (1) | $1,041,391 | |
| Cash consideration paid to settle VectivBio restricted stock units (“RSUs”) and stock options (2) | 78,003 | |
| Cash consideration paid to settle VectivBio warrants (3) | | 3,720 |
| Transaction costs | | 26,270 |
| Fair value of noncontrolling interest (4) | | 26,218 |
| Total purchase consideration | $1,175,602 |
| (1) | The cash consideration paid to selling shareholders was determined based on the total number of the outstanding ordinary shares of VectivBio (the “VectivBio Shares”) tendered at closing of 61,258,315 at a per share price of $17.00. |
| (2) | The cash consideration paid to settle VectivBio RSUs and stock options issued under VectivBio’s equity incentive plans was determined based on the total number of underlying VectivBio Shares of 8,904,171 at a per share price of $17.00, less the exercise price for stock options. |
| (3) | The cash consideration paid to settle VectivBio warrants was determined based on the total number of VectivBio warrant shares outstanding at close of 324,190 at a per share price of $11.4757 calculated as the per share price of $17.00, less the exercise price of $5.5243 per share. |
| (4) | The fair value of the noncontrolling interest was determined based on the total number of VectivBio Shares outstanding at closing of 1,547,723 at the closing date of the tender offer, using the VectivBio closing share price on June 28, 2023 of $16.94. |
On December 12, 2023, the Company completed the Squeeze-out Merger and paid $26.3 million to acquire all remaining outstanding VectivBio Shares in cash. As of December 31, 2023, there wasno remaining noncontrolling interest in VectivBio.
The VectivBio Acquisition was accounted for as an asset acquisition under Accounting Standards Codification (“ASC”) Topic 805,Business Combinations, because substantially all of the fair value of the gross assets acquired was concentrated in a single identifiable in-process research and development (“IPR&D”) asset, apraglutide, VectivBio’s lead investigational asset. Apraglutide is a next-generation, long-acting synthetic GLP-2 analog being developed for a range of rare GI diseases for the potential treatment of SBS-IF. The Company recognized the acquired assets and assumed liabilities based on the consideration paid, inclusive of transaction costs, on a relative fair value basis. In accordance with the accounting for asset acquisitions, an entity that acquires IPR&D assets in an asset acquisition follows the guidance in ASC Topic 730Research and Development, which requires that both tangible and intangible identifiable research and development assets with no alternative future use be allocated a portion of the consideration transferred and recorded as research and development expense at the acquisition date. As a result, the Company recorded approximately $1.1 billion in acquired IPR&D expense related to the apraglutide IPR&D asset during the second quarter of 2023.
The following is the allocation of the purchase consideration based on the relative fair value of assets acquired and liabilities assumed by the Company (in thousands):
| | | |
|---|---|---|
| Assets acquired | | |
| Cash and cash equivalents | $123,340 | |
| Prepaid expenses and other current assets | | 10,867 |
| Property and equipment | | 126 |
| Intangible assets | | 4,100 |
| Acquired in-process research and development | | 1,090,449 |
| Total assets acquired | $1,228,882 |
| Liabilities assumed | | |
|---|---|---|
| Current liabilities | | 37,377 |
| Other liabilities | | 15,903 |
| Total liabilities assumed | $53,280 | |
| | | |
| Net assets acquired | $1,175,602 |
The Company incurred acquisition-related expenses of $2.4 million and $3.6 million, respectively, for the three and six months ended June 30, 2024, of which $0.4 million and $1.1 million, respectively, were included in selling, general and administrative expenses, an insignificant amount, were included in research and development expense, and $2.1 million and $2.5 million, respectively, were included in restructuring expense within the Company’s condensed consolidated statement of income (loss) for the three and six months ended June 30, 2024. The Company incurred acquisition-related expenses of $45.2 million for the three and six months ended June 30, 2023, of which $20.9 million were included in selling, general and administrative expenses, $14.8 million were included in research and development expense, and $9.6 million were included in restructuring expense within the Company’s condensed consolidated statement of income (loss) for the three and six months ended June 30, 2023. Acquisition-related expenses include direct and incremental costs incurred in connection with the transaction, including integration-related professional services and employee retention-related benefits. Acquisition-related expenses exclude transaction costs included in the computation of total consideration paid.
Intangible assets are comprised of the assembled workforce and are amortized on a straight-line basis over an estimated useful life offive years. The Company recognized $0.2 million and $0.4 million of amortization expense during the three and six months ended June 30, 2024, respectively. The Company recognized an insignificant amount of amortization expense during the three and six months ended June 30, 2023. The net carrying value of the assembled workforce was $3.3 million and $3.6 million as of June 30, 2024 and December 31, 2023, respectively. Future annual amortization expense will be $0.8 million for each of the years ending December 31, 2024 through December 31, 2027 and $0.4 million for the year ended December 31, 2028.
4. NetLoss Per Share
Basic and diluted net loss per common share is computed by dividing net loss attributable to Ironwood Pharmaceuticals, Inc. stockholders by the weighted average number of common shares outstanding during the period.
The outstanding securities set forth in the following table have been excluded from the computation of diluted weighted average shares outstanding, as applicable, as their effect would be anti-dilutive (in thousands):
| | | | | | | | | |
|---|---|---|---|---|---|---|---|---|
| · · Three Months Ended · · Six Months Ended | ||||||||
| · · June 30, · · June 30, | ||||||||
| · 2024 · 2023 · · 2024 · 2023 | ||||||||
| Stock options | | 4,759 | | 4,855 | | 3,891 | 4,957 | |
| Time-based restricted stock units | | 5,450 | | 1,365 | | 1,467 | | 920 |
| Performance-based restricted stock units | | 65 | | 230 | | 65 | | 146 |
| Note Hedge Warrants | | — | | 1,848 | | — | | 5,083 |
| 2024 Convertible Notes | | — | | 14,934 | | — | | 14,934 |
| 2026 Convertible Notes | | 14,934 | | 14,934 | | 14,934 | | 14,934 |
| Total | 25,208 | 38,166 | | 20,357 | 40,974 | |||
There was no dilutive impact of the 2024 Convertible Notes (as defined below) for the three and six months ended June 30, 2024 because the Company had elected prior to the beginning of the period to settle the conversion of 2024 Convertible Notes, if any, with a combination settlement of a cash payment equal to the principal value of converted notes and shares of Class A Common Stock equal to the conversion value in excess of the principal value, if any (Note 9). Accordingly, interest expense was not removed from the numerator and there was no calculated spread added to the denominator because the average market price of the Company’s Class A Common Stock during the period was not in excess of the conversion price.
5. Collaboration, License and Other Agreements
The Company has linaclotide collaboration agreements with AbbVie for North America and AstraZeneca for China (including Hong Kong and Macau), as well as linaclotide license agreements with Astellas for Japan and with AbbVie for the AbbVie License Territory. The following table provides amounts included in the Company’s condensed consolidated statements of income (loss) as collaborative arrangements revenue attributable to transactions from these and other agreements (in thousands):
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Three Months Ended · · Six Months Ended | ||||||||||||
| · · June 30, · · June 30, | ||||||||||||
| Collaborative Arrangements Revenue | | 2024 | 2023 | | 2024 | 2023 | ||||||
| Linaclotide Collaboration and License Agreements: | | | | | | | | | | | | |
| AbbVie (North America) | | $92,154 | | $105,482 | | $164,609 | | $207,818 | ||||
| AbbVie (Europe and other) | | | 833 | | | 694 | | | 1,539 | | | 1,357 |
| AstraZeneca (China, including Hong Kong and Macau) | | | 74 | | 121 | | | 195 | | 212 | ||
| Astellas (Japan) | | | 419 | | 482 | | | 787 | | 873 | ||
| Other Agreements: | | | | | | | | | | | | |
| Asahi Kasei Pharma Corporation (apraglutide) | | | 558 | | | 63 | | | 1,269 | | | 63 |
| Other | | | 358 | | | 540 | | | 874 | | | 1,120 |
| Total collaborative arrangements revenue | | $94,396 | | $107,382 | | $169,273 | | $211,443 | ||||
Accounts receivable, net, included $58.1 million and $129.1 million primarily related to collaborative arrangements revenue as of June 30, 2024 and December 31, 2023, respectively. Accounts receivable, net, included $57.1 million and $112.6 million due from the Company’s partner, AbbVie, net of $7.5 million and $4.3 million of accounts payable, as of June 30, 2024 and December 31, 2023, respectively.
The Company routinely assesses the creditworthiness of its license and collaboration partners. The Company did not experience any material losses related to receivables from its license or collaboration partners during the three and six months ended June 30, 2024 and 2023.
Linaclotide Agreements
Collaboration Agreement for North America with AbbVie
In September 2007, the Company entered into a collaboration agreement with AbbVie to develop and commercialize linaclotide for the treatment of IBS-C, CIC, and other GI conditions in North America. Under the terms of this collaboration agreement, the Company received an upfront licensing fee, equity investment, and development and regulatory milestones, and shares equally with AbbVie all development costs as well as net profits or losses from the development and sale of linaclotide in the U.S. In addition, the Company receives royalties in the mid-teens percent based on net sales in Canada and Mexico. AbbVie is solely responsible for the further development, regulatory approval and commercialization of linaclotide in those countries and funding any costs.
During the three and six months ended June 30, 2024, the Company incurred $1.9 million and $3.5 million, respectively, in total research and development expenses under the linaclotide collaboration for North America. During the three and six months ended June 30, 2023, the Company incurred $2.0 million and $3.4 million, respectively, in total research and development expenses under the linaclotide collaboration for North America. As a result of the research and development cost-sharing provisions of the linaclotide collaboration for North America, the Company incurred $2.9 million and $5.2 million in incremental research and development costs during the three and six months ended June 30, 2024, respectively, and incurred $3.1 million and $6.1 million in incremental research and development costs during the three and six months ended June 30, 2023, respectively, to reflect the obligations of each party under the collaboration to bear 50% of the development costs incurred.
The Company and AbbVie began commercializing LINZESS in the U.S. in December 2012. The Company receives 50% of the net profits and bears 50% of the net losses from the commercial sale of LINZESS in the U.S. Net profits or net losses consist of net sales of LINZESS to third-party customers and sublicense income in the U.S. less the cost of goods sold as well as selling, general and administrative expenses. LINZESS net sales are calculated and
recorded by AbbVie and may include gross sales net of discounts, rebates, allowances, sales taxes, freight and insurance charges, and other applicable deductions.
The Company evaluated its linaclotide collaboration arrangement for North America and concluded that all development-period performance obligations had been satisfied as of September 2012. The Company has determined that there arethree remaining commercial-period performance obligations, which include the sales detailing of LINZESS, participation in the joint commercialization committee, and approved additional trials. The consideration remaining includes cost reimbursements in the U.S. and net profit and loss sharing payments based on net sales in the U.S. Additionally, the Company receives royalties in the mid-teens percent based on net sales in Canada and Mexico. Royalties and net profit and loss sharing payments will be recorded as collaborative arrangements revenue or expense in the period earned, as these payments relate predominately to the license granted to AbbVie. The Company records royalty revenue in the period earned based on royalty reports from its partner, if available, or based on the projected sales and historical trends. The cost reimbursements received from AbbVie during the commercialization period will be recognized as earned in accordance with the right-to-invoice practical expedient, as the Company’s right to consideration corresponds directly with the value of the services transferred during the commercialization period.
Under the Company’s linaclotide collaboration agreement for North America, LINZESS net sales are calculated and recorded by AbbVie and include gross sales net of discounts, rebates, allowances, sales taxes, freight and insurance charges, and other applicable deductions, as noted above. These amounts include the use of estimates and judgments, which could be adjusted based on actual results in the future. The Company records its share of the net profits or net losses from the sales of LINZESS in the U.S. less commercial expenses on a net basis, and presents the settlement payments to and from AbbVie as collaboration expense or collaborative arrangements revenue, as applicable. This treatment is in accordance with the Company’s revenue recognition policy, given that the Company is not the primary obligor and does not have the inventory risks in the collaboration agreement with AbbVie for North America. The Company relies on AbbVie to provide accurate and complete information related to net sales of LINZESS in accordance with U.S. generally accepted accounting principles in order to calculate its settlement payments to and from AbbVie and record collaboration expense or collaborative arrangements revenue, as applicable.
During the three and six months ended June 30, 2024, the Company recognized an $8.5 million and $38.0 million reduction to collaboration revenue, respectively, as a result of changes in estimates of sales reserves and allowances associated with governmental and contractual rebates. Excluding the changes in estimates, net loss per share – basic and net loss per share – diluted would each have been $0.03 for the three months ended June 30, 2024, and would have been $0.13 and $0.12, respectively, for the six months ended June 30, 2024.
The following table summarizes collaborative arrangements revenue from thelinaclotide collaboration agreement for North America (in thousands):
| · · · · · · · · · · · · | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| · · Three Months Ended · · Six Months Ended | ||||||||||
| · · June 30, · · June 30, | ||||||||||
| · 2024 · 2023 · 2024 · 2023 | ||||||||||
| Collaborative arrangements revenue related to sales of LINZESS in the U.S. | | $91,415 | | $104,751 | | $163,130 | | $206,387 | ||
| Royalty revenue | | 739 | | 731 | | 1,479 | | | 1,431 | |
| Total collaborative arrangements revenue | | $92,154 | | $105,482 | | $164,609 | | $207,818 | ||
The Company incurred $9.4 million and $19.6 million in total selling, general and administrative costs related to the sale of LINZESS in the U.S. in accordance with the cost-sharing arrangement with AbbVie for the three and six months ended June 30, 2024, respectively. The Company incurred $9.5 million and $19.3 million in total selling, general and administrative costs related to the sale of LINZESS in the U.S. in accordance with the cost-sharing arrangement with AbbVie for the three and six months ended June 30, 2023, respectively.
In May 2014, CONSTELLA® became commercially available in Canada and, in June 2014, LINZESS became commercially available in Mexico. The Company records royalties on sales of CONSTELLA in Canada and LINZESS in Mexico in the period earned. The Company recognized $0.7 million and $1.5 million of combined royalty revenues from Canada and Mexico during the three and six months ended June 30, 2024, respectively. The Company recognized $0.7 million and $1.4 million of combined royalty revenues from Canada and Mexico during the three and six months ended June 30, 2023, respectively.
License Agreement with AbbVie (All countries other than the countries and territories of North America, China (including Hong Kong and Macau), and Japan)
The Company has a license agreement with AbbVie to develop, manufacture and commercialize linaclotide in (i) Europe, and (ii) all other countries other than China (including Hong Kong and Macau), Japan, and the countries and territories of North America, or collectively the “Expanded Territory”, for the treatment of IBS-C, CIC and other GI conditions.
Under the license agreement, as amended, AbbVie is obligated to pay the Company, (i) royalties based on sales volume in Europe in theupper-teens percent, and (ii) on a country-by-country and product-by-product basis in the Expanded Territory, a royalty as a percentage of net sales of products containing linaclotide as an active ingredient in the upper-single digits forfive years following the first commercial sale of a linaclotide product in a country, and in the low-double digits thereafter. The royalty rate for products in Europe and the Expanded Territory will decrease, on a country-by-country basis, to the lower-single digits, or cease entirely, following the occurrence of certain events. The license agreement also contains certain sales-based milestones and commercial launch milestones, which could total up to $42.5 million. The Company recognized$0.8 million and$1.5 million of royalty revenue during the three and six months ended June 30, 2024, respectively. The Company recognized$0.7 million and$1.3 million of royalty revenue during the three and six months ended June 30, 2023, respectively.
License Agreement for Japan with Astellas
The Company has a license agreement with Astellas to develop, manufacture, and commercialize linaclotide for the treatment of IBS-C, CIC and other GI conditions in Japan.
Under the license agreement, as amended, Astellas is required to pay royalties to the Company at rates beginning in the mid-single digit percent and escalating to low-double-digit percent, based on aggregate annual net sales in Japan of products containing linaclotide as an active ingredient. These royalty payments are subject to reduction following the expiration of certain licensed patents and the occurrence of generic competition in Japan.
The Company recognized $0.4 million and $0.8 million of royalty revenue during the three and six months ended June 30, 2024, respectively. The Company recognized $0.5 million and $0.9 million of royalty revenue during the three and six months ended June 30, 2023, respectively.
Collaboration Agreement for China (including Hong Kong and Macau) with AstraZeneca
The Company has a collaboration agreement with AstraZeneca under which AstraZeneca has the exclusive right to develop, manufacture and commercialize products containing linaclotide in the AstraZeneca License Territory.
Under the collaboration agreement, AstraZeneca is required to pay tiered royalties to the Company at rates beginning in the mid-single-digit percent and increasing up totwenty percent based on the aggregate annual net sales of products containing linaclotide in the AstraZeneca License Territory. In addition, AstraZeneca may be required to make milestone payments totaling up to $90.0 million contingent on the achievement of certain sales targets.
The Company recognized an insignificant amount and $0.2 million of royalty revenue during the three and six months ended June 30, 2024. The Company recognized an insignificant amount and $0.2 million of royalty revenue during the three and six months ended June 30, 2023, respectively.
At December 31, 2023, the Company had accounts receivable in the amount of $15.0 million related to the third and final installment of a non-contingent receivable due from AstraZeneca in connection with an amendment to the collaboration agreement executed during 2019. The non-contingent receivable was collected in full during the first quarter of 2024.
Apraglutide Agreements
Development and Commercialization Agreement with AKP
In March 2022, VectivBio entered into a development and commercialization agreement with Asahi Kasei Pharma Corporation (“AKP”) in which VectivBio granted an exclusive license to AKP, with the right to sublicense in multiple tiers, to develop, commercialize and exploit products derived from apraglutide in Japan.
Pursuant to the terms of the development and commercialization agreement with AKP, VectivBio received an upfront payment of JPY 3,000 million ($24.6 million at date of agreement) and development-related payments of JPY 1,600 million in the aggregate ($13.1 million at date of agreement) and is eligible to receive development milestones of JPY 1,000 million ($8.2 million at date of agreement) and up to JPY 19,000 million ($155.8 million at date of agreement) of commercial and sales-based milestone payments. VectivBio is also eligible to receive payments in the commercial period for manufacturing supply equal to cost-plus manufacturing mark-up and tiered royalties of up to a mid-double-digit percentage on product sales continuing until the later of (i) expiration of regulatory exclusivity in Japan, or (ii) expiration of the last valid patent claim that provides exclusivity to apraglutide in Japan (the “Royalty Term”). The development and commercialization agreement will terminate upon the expiration of the Royalty Term.
The Company identifiedtwo performance obligations consisting of the (i) exclusive license for the development and commercialization of apraglutide in Japan and (ii) development activities for conducting global trials and sharing of associated development data necessary for obtaining and maintaining regulatory approval in Japan. Each performance obligation was capable of being distinct and distinct in the context of the contract. The initial transaction price was allocated to each performance obligation on a relative standalone selling price basis. The Company assessed that it provided a right to use the license as the license exists (in terms of form and functionality) at the point in time at which it is granted and therefore, was satisfied at the inception of the arrangement. The development activities are being recognized over time as the Company performs development activities related to the global trials. The Company recognizes revenue associated with the development activities using an input method, according to the costs incurred, which in management’s judgment, is the best measure of progress towards satisfying the performance obligation. Under the sales-or-usage-based royalty exception, revenue related to sales-based milestone payments and royalty payments will be recognized as the underlying sales occur.
Prior to the VectivBio Acquisition, VectivBio had received the upfront payment of JPY 3,000 million ($24.6 million at date of agreement), development-related payments of JPY 1,100 million ($9.0 million at date of agreement), and development milestones of JPY 500 million ($4.1 million at date of agreement). Upon the acquisition of VectivBio on June 29, 2023, the Company assumed a contract liability for deferred revenue related to the development-related payments at its fair value of $4.3 million.
In April 2024, VectivBio received the final development-related payment of JPY 500 million ($4.1 million at date of agreement).
The Company recognized $0.6 million and $1.3 million of revenue related to development activities during the three and six months ended June 30, 2024, respectively, and an insignificant amount during the three and six months ended June 30, 2023. As of June 30, 2024, deferred revenue of $2.1 million is reported within accrued expenses and other current liabilities and $2.4 million is reported within other liabilities (Note 8) on the condensed consolidated balance sheets. Deferred revenue and future payments received related to development activities are expected to be recognized over the course of the development activities, which are expected to occur through 2028.
License Agreement with Ferring
In August 2012, as subsequently amended and restated in December 2016, GlyPharma entered into an exclusive licensing agreement with Ferring International Center, S.A. (“Ferring”), pursuant to which Ferring granted GlyPharma an exclusive, worldwide, sublicensable license under certain patent rights and know-how controlled by Ferring relating to apraglutide and certain know-how controlled by Ferring relating to specified alternate drug compounds, to research, develop, manufacture, make, have made, import, export, use, sell, distribute, promote, advertise, dispose of or offer to sell (i) products containing apraglutide whose manufacture, use or sale is covered by a valid claim of the licensed patents, or licensed products and (ii) products, containing a specified alternate drug compound, or alternate drug products. In April 2021, the license agreement was transferred and assigned to VectivBio AG, a subsidiary of VectivBio.
Under the license agreement, as partial consideration for the rights Ferring granted to it, VectivBio AG is required to pay Ferring a high single-digit percentage royalty on worldwide annual net sales of licensed products and alternate drug products until, on a country-by-country basis and licensed product-by-licensed product or alternate drug product-by-alternate drug product basis, as applicable, the date on which the manufacture, use or sale of such licensed product or alternate drug product, as applicable, ceases to be covered by a valid claim of a patent within the licensed patents in such a country. GlyPharma was also required to issue Ferring a certain number of warrants and Class A preferred shares pursuant to a shareholders’ agreement. The equity obligations under the license agreement have been fully performed by GlyPharma.
The Company is also obligated to pay Ferring a specified percentage of the annual consideration VectivBio AG or its affiliates, including the Company, received in connection with sales of licensed product or alternate drug product by any third parties to which VectivBio AG or its affiliates, including the Company, grant a sublicense of any of the rights licensed to VectivBio AG by Ferring under this license agreement. Such percentage is in the high single digits for sales of both licensed products and alternate drug products, and such payments are owed for the duration of the royalty term for licensed products or alternate drug products, as applicable.
Other Collaboration and License Agreements
Collaboration and License Option Agreement with COUR
In November 2021, the Company entered into the COUR Collaboration Agreement, pursuant to which the Company has been granted the Option to acquire an exclusive license to research, develop, manufacture and commercialize, in the U.S., products containing CNP-104 for the treatment of PBC. COUR has initiated a clinical study to evaluate the safety, tolerability, and pharmacodynamic effects and efficacy of CNP-104 in PBC patients.
Pursuant to the terms of the COUR Collaboration Agreement, the Company made an upfront, non-refundable payment of $6.0 million to COUR during the year ended December 31, 2021, and agreed to pay $13.5 million in non-contingent payments and milestone payments in connection with certain development activities and regulatory milestones. After reviewing the data from the clinical study for CNP-104, if the Company exercises the Option, the Company will pay COUR $35.0 million in exchange for the license, subject to the Company’s right to apply a credit against such payment as described below. Upon commercialization, COUR will be eligible to receive commercial milestone payments of up to $440.0 million over the term of the agreement and royalties in the high-single digits to low-double digits percentage of the aggregated annual net sales in the U.S. of products containing CNP-104.
In April 2023, the Company and COUR executed an amendment to the COUR Collaboration Agreement, in which the Company agreed to pay a one-time, non-refundable, upfront payment of $6.0 million to COUR in exchange for the right to apply a credit of $6.6 million against future amounts due to COUR in connection with the exercise of the Option, commercial milestones, or royalties. In connection with such payment, COUR also granted the Company a right of first negotiation over certain additional potential research and development programs. The $6.0 million payment was recognized as research and development expense in the second quarter of 2023.
6. Fair Value of Financial Instruments
The tables below present information about the Company’s assets and liabilities that are measured at fair value on a recurring basis as of June 30, 2024 and December 31, 2023 and indicate the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value. In general, fair values determined by Level 1 inputs utilize
observable inputs such as quoted prices in active markets for identical assets or liabilities. Fair values determined by Level 2 inputs utilize data points that are either directly or indirectly observable, such as quoted prices for similar instruments in active markets, interest rates and yield curves. Fair values determined by Level 3 inputs utilize unobservable data points in which there is little or no market data, which require the Company to develop its own assumptions for the asset or liability.
The Company’s investment portfolio may include fixed income securities that do not always trade on a daily basis. As a result, the pricing services used by the Company apply other available information as applicable through processes such as benchmark yields, benchmarking of like securities, sector groupings and matrix pricing to prepare valuations. In addition, model processes are used to assess interest rate impact and develop prepayment scenarios. These models take into consideration relevant credit information, perceived market movements, sector news and economic events. The inputs into these models may include benchmark yields, reported trades, broker-dealer quotes, issuer spreads and other relevant data. The Company validates the prices provided by its third-party pricing services by obtaining market values from other pricing sources and analyzing pricing data in certain instances. The Company periodically invests in certain reverse repurchase agreements, which are collateralized by Government Securities and Obligations for an amount not less than 102% of their principal amount. The Company does not record an asset or liability for the collateral as the Company is not permitted to sell or re-pledge the collateral. The collateral has at least the prevailing credit rating of U.S. Government Treasuries and Agencies. The Company utilizes a third-party custodian to manage the exchange of funds and ensure the collateral received is maintained at 102% of the reverse repurchase agreements principal amount on a daily basis.
The following tables present the assets and liabilities the Company has measured at fair value on a recurring basis (in thousands):
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · · · · Fair Value Measurements at Reporting Date Using | ||||||||||||
| · · · Quoted Prices in · Significant Other · Significant | ||||||||||||
| · · · · · Active Markets for · · Observable · · Unobservable | ||||||||||||
| · · June 30, · · Identical Assets · · Inputs · · Inputs | ||||||||||||
| · · 2024 · · (Level 1) · · (Level 2) · · (Level 3) | ||||||||||||
| Assets: | | | | | | | | | | | | |
| Cash and cash equivalents: | | | | | | | | | | | | |
| Money market funds | | $55,949 | | $55,949 | | $— | | $— | ||||
| U.S. Treasury securities | | | 10,770 | | | — | | | 10,770 | | | — |
| Commercial paper | | | 8,169 | | | — | | | 8,169 | | | — |
| Total assets measured at fair value | | $74,888 | | $55,949 | | $18,939 | | $— | ||||
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · · · · Fair Value Measurements at Reporting Date Using | ||||||||||||
| · · · Quoted Prices in · Significant Other · Significant | ||||||||||||
| · · · · · Active Markets for · · Observable · · Unobservable | ||||||||||||
| · · December 31, · · Identical Assets · · Inputs · · Inputs | ||||||||||||
| · · 2023 · · (Level 1) · · (Level 2) · · (Level 3) | ||||||||||||
| Assets: | | | | | | | | | | | | |
| Cash and cash equivalents: | | | | | | | | | | | | |
| Money market funds | | $45,939 | | $45,939 | | $— | | $— | ||||
| U.S. Treasury securities | | | 10,507 | | | — | | | 10,507 | | | — |
| Commercial paper | | | 2,240 | | | — | | | 2,240 | | | — |
| Total assets measured at fair value | | $58,686 | | $45,939 | | $12,747 | | $— | ||||
Cash equivalents, accounts receivable, prepaid expenses and other current assets, accounts payable, accrued research and development costs, accrued expenses and other current liabilities and current portion of operating lease obligations at June 30, 2024 and December 31, 2023 are carried at amounts that approximate fair value due to their short-term maturities.
Convertible Senior Notes
In August 2019, the Company issued $200.0 million aggregate principal amount of its 0.75% convertible senior notes due 2024 (the “2024 Convertible Notes”) and $200.0 million aggregate principal amount of its 1.50% convertible senior notes due 2026 (the “2026 Convertible Notes”) (Note 9). The fair value of the respective convertible senior notes, which differs from their carrying value, is influenced by interest rates, the price of the Company’s Class A Common
Stock and the volatility thereof, and the prices for the respective convertible senior notes observed in market trading, which are Level 2 inputs.
In June 2024, the Company repaid the aggregate principal amount of the 2024 Convertible Notes upon maturity(Note 9). The estimated fair value of the 2024 Convertible Notes was $209.6 million as of December 31, 2023. The estimated fair value of the 2026 Convertible Notes was $187.9 million and $217.1 million as of June 30, 2024 and December 31, 2023, respectively.
Revolving Credit Agreement
Outstanding borrowings under the revolving credit facility (Note 9) are carried at amounts that approximate fair value based on their nature, terms, credit spreads, and variable interest rates, which are Level 3 inputs.
Non-recurring Fair Value Measurements
Acquired IPR&D
The fair value of the acquired IPR&D asset, apraglutide, was determined using the multi-period excess earnings method using Level 3 fair value measurements and inputs including estimated cash flows and probabilities of success.
Assembled Workforce
The fair value of the assembled workforce was determined using the replacement cost method using Level 3 fair value measurements and inputs including estimated costs and productivity metrics.
7. Leases
The Company’s lease portfolio for the three and six months ended June 30, 2024 includes office leases for its current headquarters location and other locations, vehicle leases for its salesforce representatives, and leases for computer and office equipment.
The Company’s headquarters office lease and vehicle leases require letters of credit totaling $1.2 million to secure the Company’s obligations under the lease agreements. The letters of credit are maintained under a subfacility of the revolving credit agreement (Note 9).
Lease cost is recognized on a straight-line basis over the lease term. The components of lease cost for the three and six months ended June 30, 2024 and 2023 are as follows (in thousands):
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Three Months Ended · · Six Months Ended | ||||||||||||
| · · June 30, · · June 30, | ||||||||||||
| · · 2024 · · 2023 · · 2024 · · 2023 | ||||||||||||
| Operating lease cost | | $627 | | $627 | | $1,254 | | $1,254 | ||||
| Short-term lease cost | | | 361 | | | 269 | | | 745 | | | 540 |
| Total lease cost | | $988 | | $896 | | $1,999 | | $1,794 | ||||
Supplemental information related to leases for the periods reported is as follows:
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| · · Six Months Ended · | |||||||
| · · June 30, · | |||||||
| · · 2024 · · 2023 · | |||||||
| Cash paid for amounts included in the measurement of lease liabilities (in thousands) | | $1,550 | | $1,520 | | ||
| Weighted-average remaining lease term of operating leases (in years) | | | 6.0 | | | 7.0 | |
| Weighted-average discount rate of operating leases | | | 5.8% | | 5.8% | ||
Summer Street Lease
In June 2019, the Company entered into a non-cancelable operating lease (the “Summer Street Lease”) for approximately 39,000 square feet of office space on the 23 rd floor of 100 Summer Street, Boston, Massachusetts, which began serving as the Company’s headquarters in October 2019. The Summer Street Lease terminates on June 11, 2030 and includes a 2% annual rent escalation, free rent periods, a tenant improvement allowance, and anoption to extend the term of the lease for an additional five years at a market base rental rate. The extension option is not included in the lease term used for the measurement of the lease, as it is not reasonably certain to be exercised. The lease expense, inclusive of the escalating rent payments and lease incentives, is recognized on a straight-line basis over the lease term.
At lease commencement, the Company recorded a right-of-use asset and a lease liability using an incremental borrowing rate of 5.8%. At June 30, 2024, the balances of the right-of-use asset and operating lease liability were $11.8 million and $16.6 million, respectively. At December 31, 2023, the balances of the right-of-use asset and operating lease liability were $12.6 million and $17.7 million, respectively.
Lease costs recorded during the three and six months ended June 30, 2024 were$0.6 million and $1.3 million, respectively.
Future minimum lease payments under the Summer Street Lease as of June 30, 2024 are as follows (in thousands):
| | | | |
|---|---|---|---|
| 2024 (1) | | $1,576 | |
| 2025 | | | 3,189 |
| 2026 | | 3,252 | |
| 2027 | | | 3,317 |
| 2028 | | | 3,384 |
| 2029 and thereafter | | 4,901 | |
| Total future minimum lease payments | | | 19,619 |
| Less: present value adjustment | | | (3,010) |
| Operating lease liabilities | | | 16,609 |
| Less: current portion of operating lease liabilities | | | (3,157) |
| Operating lease liabilities, net of current portion | | $13,452 |
| (1) | For the six months ending December 31, 2024. |
8. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| · · | ||||||
| · June 30, 2024 · December 31, 2023 | ||||||
| Accrued compensation and benefits | | $12,887 | | $19,937 | ||
| Accrued interest | | 5,741 | | 5,953 | ||
| Accrued restructuring liabilities | | | 4,405 | | | 8,303 |
| Accrued taxes | | | 935 | | | 1,244 |
| Other | | | 8,438 | | | 8,817 |
| Total accrued expenses and other current liabilities | | $32,406 | | $44,254 | ||
As of June 30, 2024 other accrued expenses of $8.4 million were comprised primarily of $6.3 million of uninvoiced vendor liabilities and $2.1 million of deferred revenue (Note 5). As of December 31, 2023, other accrued expenses of $8.8 million were comprised primarily of $6.1 million of uninvoiced vendor liabilities and $2.6 million of deferred revenue.
9. Debt
0.75% Convertible Senior Notes due 2024 and 1.50% Convertible Senior Notes due 2026
In August 2019, the Company issued $200.0 million aggregate principal amount of the 2024 Convertible Notes and $200.0 million aggregate principal amount of the 2026 Convertible Notes, pursuant to separate indentures (each an “Indenture” and together the “Indentures”), between the Company and U.S. Bank National Association, as trustee (the “Trustee”). The Company received net proceeds of $391.0 million from the sale of the 2024 Convertible Notes and 2026 Convertible Notes, after deducting fees and expenses of $9.0 million. The Company used $25.2 million of the net proceeds from the sale of the 2024 Convertible Notes and 2026 Convertible Notes to pay the cost of the Capped Calls, as described below.
In June 2024, the Company repaid the $200.0 million aggregate principal amount of the 2024 Convertible Notes upon maturity. The 2024 Convertible Notes bore cash interest at the annual rate of 0.75% payable on June 15 and December 15 of each year. No conversions were exercised by holders of the 2024 Convertible Notes.
The 2026 Convertible Notes bear cash interest at the annual rate of 1.50%, payable on June 15 and December 15 of each year. The 2026 Convertible Notes will mature on June 15, 2026, unless earlier converted or repurchased.
The initial conversion rate for the 2026 Convertible Notes is 74.6687 shares of Class A Common Stock (subject to adjustment as provided for in the Indenture) per $1,000 principal amount of the 2026 Convertible Notes, which is equal to an initial conversion price of approximately $13.39 per share.
The Company will settle conversions of the 2026 Convertible Notes through payment or delivery, as the case may be, of cash, shares of the Company’s Class A Common Stock or a combination of cash and shares of Class A Common Stock, at the Company’s option (subject to, and in accordance with, the settlement provisions of the Indenture).
Holders of the 2026 Convertible Notes may convert their notes at their option at any time prior to the close of business on the business day immediately preceding December 15, 2025 in multiples of $1,000 principal amount, only under the following circumstances:
| ● | during any calendar quarter commencing after the calendar quarter ending on December 31, 2019 (and only during such calendar quarter), if the last reported sale price of Class A Common Stock for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price for the 2026 Convertible Notes on each applicable trading day; |
| ● | during the five-business day period after any five consecutive trading day period (the “measurement period”) in which the “trading price” (as defined in each Indenture) per $1,000 principal amount of the 2026 Convertible Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price of Class A Common Stock and the conversion rate for the 2026 Convertible Notes on each such trading day; or |
| ● | upon the occurrence of specified corporate events described in the Indenture. |
On or after December 15, 2025 until the close of business on the second scheduled trading day immediately preceding June 15, 2026, the holders of the 2026 Convertible Notes may convert their 2026 Convertible Notes, in multiples of $1,000 principal amount, regardless of the foregoing conditions.
Upon the occurrence of fundamental changes, as described in the Indenture, prior to the maturity date of the 2026 Convertible Notes, holders of such notes may require the Company to repurchase for cash all or a portion of their notes at a repurchase price equal to 100% of the principal amount of the notes to be repurchased, plus accrued and unpaid interest. If a make-whole fundamental change, as described in the Indenture, occurs and a holder elects to convert its notes in connection with such make-whole fundamental change, such holder may be entitled to an increase in the conversion rate as described in the Indenture.
The Indenture does not contain any financial covenants or restrict the Company’s ability to repurchase the Company’s securities, pay dividends or make restricted payments in the event of a transaction that substantially increases the Company’s level of indebtedness. The Indenture provides for customary events of default. In the case of an event of default arising from specified events of bankruptcy or insolvency, all outstanding notes will become due and payable immediately without further action or notice. If any other event of default under the Indenture occurs or is continuing, the Trustee or holders of at least 25% in aggregate principal amount of the then outstanding notes may declare the principal amount of such notes to be immediately due and payable.
The Company accounts for convertible debt instruments as a single liability measured at amortized cost.
The Company’s outstanding balances for the convertible senior notes consisted of the following (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| · June 30, 2024 · · · December 31, 2023 | ||||||
| Principal: | | | | | | |
| 2024 Convertible Notes | $— | | | $200,000 | ||
| 2026 Convertible Notes | | 200,000 | | | | 200,000 |
| Less: unamortized debt issuance costs | | (1,353) | | | | (2,131) |
| Net carrying amount | $198,647 | | | $397,869 | ||
In connection with the issuance of the 2024 Convertible Notes and the 2026 Convertible Notes, the Company incurred $9.0 million of debt issuance costs, which primarily consisted of initial purchaser’s discounts and legal and other professional fees. The debt issuance costs are reflected as a reduction in the carrying value of the convertible senior notes and recorded as interest expense over the life of the 2024 Convertible Notes and the 2026 Convertible Notes.
The Company determined the expected life of the 2024 Convertible Notes and the 2026 Convertible Notes was equal to their approximately five andseven-year terms, respectively. The effective annual interest rate of the 2024 Convertible Notes for the period from the date of issuance through maturity was 1.2%. The effective annual interest rate of the 2026 Convertible Notes for the period from the date of issuance through June 30, 2024 was 1.9%. The effective annual interest rate is computed using the contractual interest and the amortization of debt issuance costs.
The following table sets forth total interest expense recognized related to convertible senior notes (in thousands):
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Three Months Ended · · Six Months Ended | ||||||||||||
| · · June 30, · · June 30, | ||||||||||||
| · 2024 · 2023 · 2024 · 2023 | ||||||||||||
| Contractual interest expense | | $1,063 | | $1,125 | | $2,188 | | $2,250 | ||||
| Amortization of debt issuance costs | | | 369 | | | 404 | | | 777 | | | 806 |
| Total interest expense | | $1,432 | | $1,529 | | $2,965 | | $3,056 | ||||
Future minimum payments under the convertible senior notes as of June 30, 2024, are as follows (in thousands):
| | | | |
|---|---|---|---|
| 2024 (1) | | $1,500 | |
| 2025 | | | 3,000 |
| 2026 | | | 201,500 |
| Total future minimum payments under the convertible senior notes | | 206,000 | |
| Less: amounts representing interest | | | (6,000) |
| Less: unamortized debt issuance costs | | | (1,353) |
| Convertible senior notes balance | | $198,647 |
| (1) | For the six months ending December 31, 2024. |
Capped Calls with Respect to 2024 Convertible Notes and 2026 Convertible Notes
To minimize the impact of potential dilution to the Company’s Class A common stockholders upon conversion of the 2024 Convertible Notes and the 2026 Convertible Notes, the Company separately entered into the capped call transactions in August 2019 (the “Capped Calls”) in connection with the issuance of the 2024 Convertible Notes and the 2026 Convertible Notes. The Company paid the counterparties $25.2 million to enter into the Capped Calls, of which $25.0 million related to the premium payments and $0.2 million related to transaction costs. These instruments meet the conditions outlined in ASC 815 to be classified in stockholders’ equity and are not subsequently remeasured as long as the conditions for equity classification continue to be met.
The Capped Calls in connection with the issuance of the 2024 Convertible Notes, which covered 14,933,740 shares of Class A Common Stock, terminated unexercised upon expiry in June 2024.
The Capped Calls in connection with the 2026 Convertible Notes have an initial strike price of approximately $13.39 per share, which corresponds to the initial conversion price of the 2026 Convertible Notes and is subject to anti-dilution adjustments generally similar to those applicable to the 2026 Convertible Notes. The Capped Calls have a cap price of approximately $17.05 per share, subject to certain adjustments. The Capped Calls cover 14,933,740 shares of Class A Common Stock (subject to anti-dilution and certain other adjustments), which is the same number of shares of Class A Common Stock that initially underlie the 2026 Convertible Notes. Holders of the 2026 Convertible Notes do not have any rights with respect to the Capped Calls.
The Capped Calls are expected generally to reduce the potential dilution to the Class A Common Stock upon conversion of the 2026 Convertible Notes in the event that the market price per share of Class A Common Stock is greater than the strike price of the Capped Calls as adjusted pursuant to the anti-dilution adjustments. If, however, the market price per share of Class A Common Stock exceeds the cap price of the Capped Calls, there would nevertheless be dilution upon conversion of the 2026 Convertible Notes to the extent that such market price exceeds the cap price of the Capped Calls.
Revolving Credit Facility
In May 2023, in connection with the VectivBio Acquisition, the Company entered into a credit agreement (the “Revolving Credit Agreement”) with Wells Fargo Bank, N.A., as administrative agent, collateral agent, a letter of credit issuer and a lender, and the other agents, lenders and letter of credit issuers parties thereto.
The Revolving Credit Agreement provides for afour-year $500.0 million secured revolving credit facility (the "Revolving Credit Facility”), which includes a $10.0 million letter of credit subfacility, and loans made thereunder will mature on the earliest to occur of (i)May 21, 2027 or (ii) the date that is 91 days prior to the stated maturity date of the Company’s existing convertible notes then outstanding, unless, in the case of clause (ii), the Company’s minimum liquidity equals or exceeds certain agreed levels.
At the Company’s election, borrowings under the Revolving Credit Agreement will bear interest at a rate equal to (a) Adjusted Term Secured Overnight Financing Rate (“Adjusted Term SOFR”) (as defined in Revolving Credit Agreement) plus the applicable rate (ranging from 1.75% to 3.00%) or (b) the highest of (1) the weighted average overnight Federal funds rate, as published by the Federal Reserve Bank of New York, plus one half of 1.0%, (2) the prime lending
rate or (3) the one-month Adjusted Term SOFR plus 1.0% in effect from time to time plus the applicable rate (ranging from 0.75% to 2.00%). The applicable rates are based on the Company’s consolidated secured net leverage ratio (as defined under the Revolving Credit Facility) at the time of the applicable borrowing.
The Company pays aquarterly commitment fee of 0.30% to 0.425% on the daily amount by which the commitments under the Revolving Credit Agreement exceed the outstanding loans and letters of credit.
The loans and other obligations under the Revolving Credit Agreement are secured by substantially all of the Company’s personal property, including a pledge of all the capital stock of subsidiaries held directly by the Company or any subsidiary that guarantees the Revolving Credit Agreement following the closing date (which pledge, in the case of any foreign subsidiary, is limited to 65% of the voting stock), subject to certain customary exceptions and limitations. The Revolving Credit Agreement generally prohibits any other liens on the assets of the Company and its restricted subsidiaries, subject to certain exceptions as described in the Revolving Credit Agreement.
Under the terms of the Revolving Credit Agreement, the Company will be able to request an increase in the commitments or the addition of a term loan secured by a pari passu lien on the collateral of up to an additional amount equal to the greater of $200.0 million and 100% of the trailing twelve-month Consolidated Adjusted EBITDA (as defined in the Revolving Credit Agreement) upon satisfaction of customary conditions, including receipt of commitments from either new lenders or increased commitments from existing lenders.
The Revolving Credit Agreement contains certain customary covenants applicable to the Company and its Restricted Subsidiaries (as defined in the Revolving Credit Agreement), and commencing in the third quarter of 2023, the Company is required to maintain a maximum consolidated secured net leverage ratio of 3.00 to 1.00 and a minimum interest coverage ratio of 3.00 to 1.00, in each case at the end of each fiscal quarter. The Revolving Credit Agreement allows the Company to elect to increase the permitted maximum consolidated secured net leverage ratio to 3.50 to 1.00 forfour fiscal quarters in the event it consummates an acquisition for consideration in excess of $50.0 million, subject to certain limitations on how often this election can be made. As of June 30, 2024, the Company was in compliance with all covenants under the Revolving Credit Agreement.
In connection with the Revolving Credit Agreement, the Company incurred $2.9 million of debt issuance costs, which primarily consisted of $2.0 million of lender fees and $0.9 million of legal and other professional fees. The debt issuance costs are classified as other assets and are amortized on a straight-line basis over thefour-year term of the Revolving Credit Agreement. The Company had unamortized capitalized debt issuance costs of $2.1 million and $2.4 million at June 30, 2024 and December 31, 2023, respectively.
In June 2023, the Company borrowed $400.0 million to partially finance the VectivBio Acquisition. The outstanding principal balance on the revolving credit facility was $425.0 million and $300.0 million as of June 30, 2024 and December 31, 2023, respectively.
The following table sets forth total interest expense recognized related to the Revolving Credit Agreement (in thousands):
| | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Three Months Ended · · · Six Months Ended · | |||||||||||||
| · · June 30, · · · June 30, · | |||||||||||||
| · 2024 · 2023 · · · 2024 · 2023 · | |||||||||||||
| Contractual interest expense | | $5,841 | | $216 | | $11,598 | | $216 | | ||||
| Amortization of debt issuance costs | | | 180 | | | 81 | | | 361 | | | 81 | |
| Other financing costs | | | 13 | | | 14 | | | 25 | | | 14 | |
| Total interest expense | | $6,034 | | $311 | | $11,984 | | $311 | | ||||
10. Employee Stock Benefit Plans
The Company has several share-based compensation plans under which stock options, restricted stock awards, restricted stock units and other share-based awards are available for grant to employees, officers, directors and consultants of the Company.
The following table summarizes share-based compensation expense (in thousands):
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Three Months Ended · · Six Months Ended | ||||||||||||
| · · June 30, · · June 30, | ||||||||||||
| | 2024 | 2023 | 2024 | 2023 | ||||||||
| Share-based compensation expense: | | | | | | | | | | | | |
| Research and development | | $1,833 | | $12,756 | | $4,046 | | $14,111 | ||||
| Selling, general and administrative | | | 6,737 | | 22,147 | | 12,909 | | | 27,923 | ||
| Restructuring | | | — | | | 911 | | — | | 911 | ||
| Total share-based compensation expense included in operating expenses | | | 8,570 | | | 35,814 | | | 16,955 | | | 42,945 |
| Income tax benefit | | | 648 | | | 923 | | | 2,013 | | | 1,220 |
| Total share-based compensation expense, net of tax | | $7,922 | | $34,891 | | $14,942 | | $41,725 | ||||
In connection with the VectivBio Acquisition, the Company incurred$27.5 million of share-based compensation expense during the three and six months ended June 30, 2023 related to the vesting acceleration and settlement of outstanding VectivBio stock options and RSUs under VectivBio’s 2021 Equity Incentive Plan, of which$11.3 million was recorded within research and development expense and$16.2 million was recorded within selling, general and administrative expenses, respectively.
.
11. Income Taxes
The income tax provision during interim periods is computed by applying an estimated annual U.S. effective income tax rate to U.S. year-to-date pre-tax income, plus adjustments for significant unusual or infrequently occurring items, in accordance with ASC Subtopic 740-270,Income Taxes – Interim Reporting. Year-to-date pre-tax net loss generated in Switzerland is not included in the interim period income tax provision, as the related deferred tax assets are reserved in full by a valuation allowance.
During the three and six months ended June 30, 2024 the Company recorded income tax expense of $19.7 million and $28.9 million, respectively. During the three and six months ended June 30, 2023, the Company recorded income tax expense of $13.3 million and $33.4 million, respectively. Due to the Company's ability to offset its pre-tax income against net operating losses, the majority of its tax provision is expected to represent a non-cash expense until its net operating losses have been fully utilized.
The Company continues to record a valuation allowance against certain deferred tax assets comprised primarily of net operating loss carryforwards in Switzerland, as well as U.S. federal and state tax credits that are expected to expire prior to utilization. On a periodic basis, the Company reassesses the valuation allowance on its deferred income tax assets, weighing positive and negative evidence to assess the recoverability of the deferred tax assets.
12. Workforce Reductions and Restructuring
In April 2023, the Company reduced its workforce by approximately 10% of its headquarters-based personnel in an effort to further strengthen the operational efficiency of the organization. The workforce reduction was substantially completed during the second quarter of 2023. The Company recorded $3.5 million of restructuring expenses and adjustments, which are primarily comprised of employee severance, benefits and related costs, during each of the three and six months ended June 30, 2023.
In June 2023, the Company commenced the elimination of certain positions in connection with the VectivBio Acquisition. The majority of the eliminations were substantially completed during the year ended December 31, 2023. During the three and six months ended June 30, 2024, the Company incurred $2.1 million and $2.5 million of restructuring expenses, respectively, which are comprised primarily of employee severance, benefits, and related costs.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.