Item 1. Financial Statements
Item 1. Financial Statements
RIGEL PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEET S
(In thousands)
September 30,
December 31,
2022
2021 (1)
(unaudited)
Assets
Current assets:
Cash and cash equivalents
$
29,866
$
18,890
Short-term investments
51,776
106,077
Accounts receivable, net
15,525
15,472
Inventories
7,116
6,616
Prepaid and other current assets
6,157
7,412
Total current assets
110,440
154,467
Property and equipment, net
1,694
2,184
Operating lease right-of-use asset
2,991
9,703
Other assets
484
974
$
115,609
$
167,328
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable
$
2,721
$
3,795
Accrued compensation
8,773
10,690
Accrued research and development
7,574
10,384
Other accrued liabilities
17,602
12,691
Lease liabilities, current portion
3,314
9,892
Deferred revenue
1,369
2,596
Other long-term liabilities, current portion
5,912
13,506
Total current liabilities
47,265
63,554
Long-term portion of lease liabilities
—
759
Loans payable, net of discount
39,468
19,914
Other long-term liabilities
48,710
52,727
Commitments
Stockholders’ equity (deficit):
Preferred stock
—
—
Common stock
173
172
Additional paid-in capital
1,364,139
1,354,190
Accumulated other comprehensive loss
( 286 )
( 102 )
Accumulated deficit
( 1,383,860 )
( 1,323,886 )
Total stockholders’ equity (deficit)
( 19,834 )
30,374
$
115,609
$
167,328
(1) The balance sheet as of December 31, 2021 has been derived from the audited financial statements included in Rigel’s Annual Report on Form 10-K for the year ended December 31, 2021 filed with the Securities and Exchange Commission (SEC) on March 1, 2022 .
See Accompanying Notes to Condensed Financial Statements
3
Table of Contents
RIGEL PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATION S
(In thousands, except per share amounts)
(unaudited)
Three Months Ended September 30,
Nine Months Ended September 30,
2022
2021
2022
2021
Revenues:
Product sales, net
$
19,188
$
16,012
$
53,935
$
45,441
Contract revenues from collaborations
722
4,531
12,529
73,886
Government contract
2,500
1,000
2,500
9,500
Total revenues
22,410
21,543
68,964
128,827
Costs and expenses:
Cost of product sales
250
151
1,407
596
Research and development
14,666
18,300
44,907
51,933
Selling, general and administrative
25,897
22,877
80,279
67,376
Total costs and expenses
40,813
41,328
126,593
119,905
Income (loss) from operations
( 18,403 )
( 19,785 )
( 57,629 )
8,922
Interest income
192
14
255
31
Interest expense
( 826 )
( 1,317 )
( 2,600 )
( 3,561 )
Income (loss) before income taxes
( 19,037 )
( 21,088 )
( 59,974 )
5,392
Provision for (benefit from) income taxes
—
( 136 )
—
665
Net income (loss)
$
( 19,037 )
$
( 20,952 )
$
( 59,974 )
$
4,727
Net income (loss) per share
Basic
$
( 0.11 )
$
( 0.12 )
$
( 0.35 )
$
0.03
Diluted
$
( 0.11 )
$
( 0.12 )
$
( 0.35 )
$
0.03
Weighted average shares used in computing net income (loss) per share
Basic
172,836
170,886
172,256
170,297
Diluted
172,836
170,886
172,256
176,452
See Accompanying Notes to Condensed Financial Statements
4
Table of Contents
RIGEL PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(In thousands)
(unaudited)
Three Months Ended September 30,
Nine Months Ended September 30,
2022
2021
2022
2021
Net income (loss)
$
( 19,037 )
$
( 20,952 )
$
( 59,974 )
$
4,727
Other comprehensive income (loss):
Net unrealized gain (loss) on short-term investments
152
1
( 184 )
12
Comprehensive income (loss)
$
( 18,885 )
$
( 20,951 )
$
( 60,158 )
$
4,739
See Accompanying Notes to Condensed Financial Statements
5
Table of Contents
RIGEL PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)
(In thousands, except share amounts)
(unaudited)
Accumulated
Additional
Other
Total
Common Stock
Paid-in
Comprehensive
Accumulated
Stockholders’
Shares
Amount
Capital
Loss
Deficit
Equity (Deficit)
Balance as of January 1, 2022
171,602,226
$
172
$
1,354,190
$
( 102 )
$
( 1,323,886 )
$
30,374
Net loss
—
—
—
—
( 27,445 )
( 27,445 )
Net unrealized loss on short-term investments
—
—
—
( 314 )
—
( 314 )
Issuance of common stock upon exercise of options
420,521
—
940
—
—
940
Issuance of common stock upon vesting of restricted stock units
22,500
—
—
—
—
—
Stock-based compensation expense
—
—
3,243
—
—
3,243
Balance as of March 31, 2022
172,045,247
$
172
$
1,358,373
$
( 416 )
$
( 1,351,331 )
$
6,798
Net loss
—
—
—
—
( 13,492 )
( 13,492 )
Net unrealized loss on short-term investments
—
—
—
( 22 )
—
( 22 )
Issuance of common stock upon exercise of options and participation in Purchase Plan
609,839
1
598
—
—
599
Issuance of common stock upon vesting of restricted stock units
181,250
—
—
—
—
—
Stock-based compensation expense
—
—
2,440
—
—
2,440
Balance as of June 30, 2022
172,836,336
$
173
$
1,361,411
$
( 438 )
$
( 1,364,823 )
$
( 3,677 )
Net loss
—
—
—
—
( 19,037 )
( 19,037 )
Net unrealized gain on short-term investments
—
—
—
152
—
152
Stock-based compensation expense
—
—
2,728
—
—
2,728
Balance as of September 30, 2022
172,836,336
$
173
$
1,364,139
$
( 286 )
$
( 1,383,860 )
$
( 19,834 )
Accumulated
Additional
Other
Total
Common Stock
Paid-in
Comprehensive
Accumulated
Stockholders’
Shares
Amount
Capital
Loss
Deficit
Equity
Balance as of January 1, 2021
169,316,782
$
169
$
1,339,833
$
( 4 )
$
( 1,305,972 )
$
34,026
Net income
—
—
—
—
39,500
39,500
Net unrealized gain on short-term investments
—
—
—
3
—
3
Issuance of common stock upon exercise of options
813,854
1
2,096
—
—
2,097
Stock-based compensation expense
—
—
2,672
—
—
2,672
Balance as of March 31, 2021
170,130,636
$
170
$
1,344,601
$
( 1 )
$
( 1,266,472 )
$
78,298
Net loss
—
—
—
—
( 13,821 )
( 13,821 )
Net unrealized gain on short-term investments
—
—
—
8
—
8
Issuance of common stock upon exercise of options and participation in Purchase Plan
711,847
1
1,318
—
—
1,319
Stock-based compensation expense
—
—
2,306
—
—
2,306
Balance as of June 30, 2021
170,842,483
$
171
$
1,348,225
$
7
$
( 1,280,293 )
$
68,110
Net loss
—
—
—
—
( 20,952 )
( 20,952 )
Net unrealized gain on short-term investments
—
—
—
1
—
1
Issuance of common stock upon exercise of options
127,265
—
274
—
—
274
Stock-based compensation expense
—
—
2,237
—
—
2,237
Balance as of September 30, 2021
170,969,748
$
171
$
1,350,736
$
8
$
( 1,301,245 )
$
49,670
See Accompanying Notes to Condensed Financial Statements
6
Table of Contents
RIGEL PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF CASH FLOW S
(In thousands)
(unaudited)
Nine Months Ended September 30,
2022
2021
Operating activities
Net income (loss)
$
( 59,974 )
4,727
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
Stock-based compensation expense
8,305
7,147
Gain on disposal of assets
( 465 )
—
Depreciation and amortization
714
758
Non-cash interest expense
682
2,314
Net amortization and accretion of discount on short-term investments and term loan
116
171
Changes in assets and liabilities:
Accounts receivable, net
( 53 )
982
Inventories
( 394 )
( 5,325 )
Prepaid and other current assets
1,255
8,113
Other assets
490
( 111 )
Right-of-use assets
6,712
6,071
Accounts payable
( 999 )
( 656 )
Accrued compensation
( 1,917 )
( 131 )
Accrued research and development
( 2,810 )
4,586
Other accrued liabilities
4,911
2,563
Lease liability
( 7,337 )
( 6,384 )
Deferred revenue
( 1,227 )
139
Other current and long-term liabilities
142
—
Net cash provided by (used in) operating activities
( 51,849 )
24,964
Investing activities
Purchases of short-term investments
( 26,049 )
( 117,076 )
Maturities of short-term investments
80,062
31,200
Proceeds from disposal of assets
543
—
Capital expenditures
( 377 )
( 648 )
Net cash provided by (used in) investing activities
54,179
( 86,524 )
Financing activities
Cost share advance from collaboration partner
—
57,900
Cost share payments to a collaboration partner
( 12,435 )
—
Net proceeds from issuances of common stock upon exercise of options and participation in Purchase Plan
1,539
3,690
Net proceeds from term loan financing
19,542
—
Net cash provided by financing activities
8,646
61,590
Net increase in cash and cash equivalents
10,976
30
Cash and cash equivalents at beginning of period
18,890
30,373
Cash and cash equivalents at end of period
$
29,866
$
30,403
Supplemental disclosure of cash flow information
Interest paid
$
1,549
$
1,094
See Accompanying Notes to Condensed Financial Statements
7
Table of Contents
Rigel Pharmaceuticals, In c.
Notes to Condensed Financial Statements
(unaudited)
In this report, “Rigel,” “we,” “us” and “our” refer to Rigel Pharmaceuticals, Inc.
1.
Organization and Summary of Significant Accounting Policies
Description of Business
We are a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with hematologic disorders, cancer and rare immune diseases. Our pioneering research focuses on signaling pathways that are critical to disease mechanisms. Our first product approved by the US Food and Drug Administration (FDA) is TAVALISSE® (fostamatinib disodium hexahydrate) tablets, the only approved oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. The product is also commercially available in Europe, United Kingdom (UK) (TAVLESSE) and Canada (TAVALISSE) for the treatment of chronic ITP in adult patients.
Our portfolio also includes olutasidenib, an oral, small molecule inhibitor of mutated isocitrate dehydrogenase-1 (mIDH1) being investigated for the treatment of acute myeloid leukemia (AML) and other malignancies. We in-licensed olutasidenib from Forma Therapeutics, Inc. (Forma) with exclusive, worldwide rights to develop, manufacture, and commercialize the investigational drug.
We conducted a Phase 3 clinical trial evaluating fostamatinib for the treatment of warm autoimmune hemolytic anemia (wAIHA), and recently announced that we do not expect to file a supplemental New Drug Application (sNDA) for this indication at this time considering the top-line data results and the guidance received from the FDA. We recently announced the completion of the FOCUS Phase 3 clinical trial of fostamatinib for the treatment of hospitalized high-risk patients with COVID-19. Fostamatinib is also currently being studied in a National Institute of Health (NIH)/National Heart, Lung, and Blood Institute (NHLBI) sponsored Accelerating COVID-19 Therapeutic Inventions and Vaccines (ACTIV-4) Phase 3 trial (ACTIV-4 Host Tissue Trial) for the treatment of COVID-19 in hospitalized patients.
Our other clinical programs include our interleukin receptor-associated kinase (IRAK) inhibitor program and a receptor-interacting serine/threonine-protein kinase (RIPK1) inhibitor program in clinical development with partner Eli Lilly and Company (Lilly). In addition, we have product candidates in clinical development with partners BerGenBio ASA (BerGenBio) and Daiichi Sankyo (Daiichi).
Basis of Presentation
Our accompanying unaudited condensed financial statements have been prepared in accordance with United States generally accepted accounting principles (US GAAP), for interim financial information and pursuant to the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities Act of 1933, as amended (Securities Act). Accordingly, they do not include all the information and notes required by US GAAP for complete financial statements. These unaudited condensed financial statements include only normal and recurring adjustments that we believe are necessary to fairly state our financial position and the results of our operations and cash flows. Interim-period results are not necessarily indicative of results of operations or cash flows for a full-year or any subsequent interim period. The balance sheet as of December 31, 2021 has been derived from audited financial statements at that date but does not include all disclosures required by US GAAP for complete financial statements. Because certain disclosures required by US GAAP for complete financial statements are not included herein, these interim unaudited condensed financial statements and the notes accompanying them should be read in conjunction with our audited financial statements and the notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 1, 2022.
Use of Estimates
The preparation of financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. We base our
8
Table of Contents
estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances. Actual results could differ from these estimates.
Significant Accounting Policies
Our significant accounting policies are described in “Note 1 – Description of Business and Summary of Significant Accounting Policies” to our “Notes to Financial Statements” contained in “Part II, Item 8, Financial Statements and Supplementary Data” of our Annual Report on Form 10-K for the year ended December 31, 2021. There have been no material changes to these accounting policies, except for our accounting associated with our in-license agreement with Forma as discussed in detail in “Note 4 – Sponsored Research and License Agreements”.
Liquidity
As of September 30, 2022, we had approximately $ 81.6 million in cash, cash equivalents and short-term investments. Since inception, we have financed our operations primarily through sales of equity securities, debt financing, contract payments under our collaboration agreements and from product sales.
Based on our current operating plan, we believe that our existing cash, cash equivalents, and short-term investments will be sufficient to fund our expenses and capital expenditure requirements for at least the next 12 months from the date of issuance of this Form 10-Q.
Recently Issued Accounting Standards
No new accounting guidance adopted during the period. Recently issued accounting guidance is not applicable or did not have, or is not expected to have, a material impact to us.
2.
Net Income (Loss) Per Share
Basic net income (loss) per share is computed by dividing net income (loss) by the weighted-average number of shares of common stock outstanding during the period. Diluted net income (loss) per share is computed by dividing net income (loss) by the weighted-average number of shares of common stock outstanding during the period and the number of additional shares of common stock that would have been outstanding if potentially dilutive securities had been issued. Potentially dilutive securities include stock options, restricted stock units and shares issuable under our Employee Stock Purchase Plan (Purchase Plan). The dilutive effect of these potentially dilutive securities is reflected in diluted earnings per share by application of the treasury stock method. Under the treasury stock method, an increase in the fair market value of our common stock can result in a greater dilutive effect from potentially dilutive securities.
The following table sets forth the computation of basic and diluted earnings per share (in thousands except per share amounts):
Three Months Ended September 30,
Nine Months Ended September 30,
2022
2021
2022
2021
EPS Numerator:
Net income (loss)
$
( 19,037 )
$
( 20,952 )
$
( 59,974 )
$
4,727
EPS Denominator—Basic and Diluted:
Weighted-average common shares outstanding
172,836
170,886
172,256
170,297
EPS Denominator—Diluted:
Weighted-average common shares outstanding
172,836
170,886
172,256
170,297
Dilutive effect of stock options, restricted stock units and shares under Purchase Plan
—
—
—
6,155
Weighted-average shares outstanding and common stock equivalents
172,836
170,886
172,256
176,452
Net income (loss) per share
Basic
$
( 0.11 )
$
( 0.12 )
$
( 0.35 )
$
0.03
Diluted
$
( 0.11 )
$
( 0.12 )
$
( 0.35 )
$
0.03
9
Table of Contents
The potential shares of common stock that were excluded from the computation of diluted net income (loss) per share for the periods presented because including them would have been antidilutive are as follows (in thousands):
Three Months Ended September 30,
Nine Months Ended September 30,
2022
2021
2022
2021
Outstanding stock options
32,687
30,490
32,687
9,450
Restricted stock units
1,174
234
1,174
4
Purchase Plan
398
313
398
—
Total
34,259
31,037
34,259
9,454
3.
Revenues
Revenues disaggregated by category were as follows (in thousands):
Three Months Ended September 30,
Nine Months Ended September 30,
2022
2021
2022
2021
Product sales:
Gross product sales
$
26,977
$
20,546
$
76,022
58,692
Discounts and allowances
( 7,789 )
( 4,534 )
( 22,087 )
( 13,251 )
Total product sales, net
19,188
16,012
53,935
45,441
Revenues from collaborations:
License revenues
—
2,431
2,545
70,354
Development milestones
—
1,875
5,000
1,875
Research and development services and others
722
225
4,984
1,657
Total revenues from collaborations
722
4,531
12,529
73,886
Government contract
2,500
1,000
2,500
9,500
Total revenues
$
22,410
$
21,543
$
68,964
$
128,827
Our net product sales include sales of TAVALISSE in the US, net of chargebacks, discounts and fees, government and other rebates and returns. The following tables summarize the activities in chargebacks, discounts and fees, government and other rebates and returns that were accounted for within other accrued liabilities, for each of the periods presented (in thousands):
Chargebacks,
Government
Discounts and
and Other
Fees
Rebates
Returns
Total
Balance as of January 1, 2022
$
3,404
$
2,494
$
2,017
$
7,915
Provision related to current period sales
14,475
4,130
1,045
19,650
Credit or payments made during the period
( 11,920 )
( 4,257 )
( 199 )
( 16,376 )
Balance as of September 30, 2022
$
5,959
$
2,367
$
2,863
$
11,189
Chargebacks,
Government
Discounts and
and Other
Fees
Rebates
Returns
Total
Balance as of January 1, 2021
$
2,461
$
2,115
$
1,489
$
6,065
Provision related to current period sales
7,326
3,995
739
12,060
Credit or payments made during the period
( 7,073 )
( 3,367 )
( 387 )
( 10,827 )
Balance as of September 30, 2021
$
2,714
$
2,743
$
1,841
$
7,298
Of the $ 22.1 million discounts and allowances from gross product sales for the nine months ended September 30, 2022, $ 19.7 million was accounted for as additions to other accrued liabilities and $ 2.4 million as reductions in accounts receivable (as it relates to allowance for prompt pay discount) and prepaid and other current assets (as it relates to certain chargebacks and other fees that were prepaid) in the condensed balance sheet.
10
Table of Contents
Of the $ 13.3 million discounts and allowances from gross product sales for the nine months ended September 30, 2021, $ 12.1 million was accounted for as additions to other accrued liabilities and $ 1.2 million as reductions in accounts receivable (as it relates to allowance for prompt pay discount) and prepaid and other current assets (as it relates to certain chargebacks and other fess that were prepaid) in the condensed balance sheet.
For detailed discussions of our revenues from collaboration and government contract, see “Note 4 – Sponsored Research and License Agreements and Government Contract” below.
The following table summarizes the percentages of revenues from each of our customers who individually accounted for 10% or more (wherein * denotes less than 10%) of the total net product sales and revenues from collaborations:
Three Months Ended September 30,
Nine Months Ended September 30,
2022
2021
2022
2021
McKesson Specialty Care Distribution Corporation
44 %
35 %
38 %
17 %
Cardinal Healthcare
27 %
18 %
22 %
*
ASD Healthcare and Oncology Supply
25 %
25 %
21 %
15 %
Lilly
*
12 %
*
56 %
Kissei
*
*
11 %
*
4.
Sponsored Research and License Agreements and Government Contract
Sponsored Research and License Agreements
We conduct research and development programs independently and in connection with our corporate collaborators. As of September 30, 2022, we are a party to collaboration agreements with Lilly to develop and commercialize R552, a RIPK1 inhibitor, for the treatment of non-central nervous system (non-CNS) diseases and collaboration aimed at developing additional RIPK1 inhibitors for the treatment of central nervous system (CNS) diseases; with Grifols S.A. (Grifols) to commercialize fostamatinib for human diseases in all indications, including chronic ITP and autoimmune hemolytic anemia (AIHA), in Europe and Turkey; with Kissei Pharmaceutical Co., Ltd. (Kissei) to develop and commercialize fostamatinib in Japan, China, Taiwan and the Republic of Korea; with Medison Pharma Trading AG (Medison Canada) and Medison Pharma Ltd. (Medison Israel and, together with Medison Canada, Medison) to commercialize fostamatinib in all indications, including chronic ITP and AIHA, in Canada and Israel, respectively; and with Knight Therapeutics International SA (Knight) to commercialize fostamatinib in all indications, including chronic ITP and AIHA, in Latin America, consisting of Mexico, Central and South America, and the Caribbean (Knight territory).
Further, we are also a party to collaboration agreements, but do not have ongoing performance obligations with BerGenBio for the development and commercialization of AXL inhibitors in oncology, and with Daiichi to pursue research related to MDM2 inhibitors, a novel class of drug targets called ligases. We had an agreement with AstraZeneca AB (AZ) for the development and commercialization of R256, an inhaled JAK inhibitor. In December 2021, AZ provided a notice to terminate the agreement effective April 19, 2022 and returned to us the full rights to our propriety JAK inhibitor.
Under the above existing agreements that we entered into in the ordinary course of business, we received or may be entitled to receive upfront cash payments, payments contingent upon specified events achieved by such partners and royalties on any net sales of products sold by such partners under the agreements. As of September 30, 2022, total future contingent payments to us under all of above existing agreements, excluding terminated agreements, could exceed $ 1.3 billion if all potential product candidates achieved all of the payment triggering events under all of our current agreements. Of this amount, $ 279.5 million relates to the achievement of development events, $ 283.1 million relates to the achievement of regulatory events and $ 796.0 million relates to the achievement of certain commercial events. This estimated future contingent amount does not include any estimated royalties that could be due to us if the partners successfully commercialize any of the licensed products. Future events that may trigger payments to us under the agreements are based solely on our partners’ future efforts and achievements of specified development, regulatory and/or commercial events.
11
Table of Contents
Global Exclusive License Agreement with Lilly
On February 18, 2021, we entered into a global exclusive license agreement and strategic collaboration with Lilly (Lilly Agreement), which became effective on March 27, 2021, to develop and commercialize R552, a RIPK1 inhibitor, for the treatment of non-CNS diseases. In addition, the collaboration is aimed at developing additional RIPK1 inhibitors for the treatment of CNS diseases. Pursuant to the terms of the license agreement, we granted to Lilly exclusive rights to develop and commercialize R552 and related RIPK1 inhibitors in all indications worldwide. The agreement became effective in March 2021 upon clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. The parties’ collaboration is governed through a joint governance committee and appropriate subcommittees.
We are responsible for 20 % of development costs for R552 in the US, Europe, and Japan, up to a specified cap. Lilly is responsible for funding the remainder of all development activities for R552 and other non-CNS disease development candidates. We have the right to opt-out of co-funding the R552 development activities in the US, Europe and Japan at two different specified times. If we exercise our first opt-out right (no later than September 30, 2023), under the Lilly Agreement, we are required to fund our share of the R552 development activities in the US, Europe, and Japan up to a maximum funding commitment of $ 65.0 million through April 1, 2024. If we decide not to exercise our opt-out rights, we will be required to share in global development costs of up to certain amounts at a specified cap, as provided for in the Lilly Agreement.
We are responsible for performing and funding initial discovery and identification of CNS disease development candidates. Following candidate selection, Lilly will be responsible for performing and funding all future development and commercialization of the CNS disease development candidates.
Under the terms of the license agreement, we were entitled to receive a non-refundable and non-creditable upfront cash payment amounting to $ 125.0 million, which we received in April 2021. We are also entitled to additional milestone payments for non-CNS disease products consisting of up to $ 330.0 million in milestone payments upon the achievement of specified development, regulatory and commercial milestones, and up to $ 100.0 million in sales milestone payments on a product-by-product basis. In addition, depending on the extent of our co-funding of R552 development activities, we would be entitled to receive tiered royalty payments on net sales of non-CNS disease products at percentages ranging from the mid-single digits to high-teens, subject to certain standard reductions and offsets. We are also eligible to receive milestone payments for CNS disease products consisting of up to $ 255.0 million in milestone payments upon the achievement of specified development, regulatory and commercial milestones, and up to $ 150.0 million in sales milestone payments on a product-by-product basis. We would be entitled to receive tiered royalty payments on net sales of CNS disease products up to low-double digits, subject to certain standard reductions and offsets.
We accounted for this agreement under ASC 606 and identified the following distinct performance obligations at inception of the agreement: (a) granting of the license rights over the non-CNS penetrant intellectual property (IP), and (b) granting of the license rights over the CNS penetrant IP which will be delivered to Lilly upon completion of the additional research and development efforts specified in the agreement. We concluded each of these performance obligations is distinct. We based our assessment on the assumption that Lilly can benefit from each of the licenses on its own by developing and commercializing the underlying product using its own resources.
Under the Lilly Agreement, we are required to share 20 % of the development costs for R552 in the US, Europe and Japan up to a specified cap. Given our rights to opt-out from the development of R552, we believe at the minimum, we have a commitment to fund the development costs up to $ 65.0 million as discussed above. We considered this commitment to fund the development costs as a significant financing component of the contract, which we accounted for as a reduction of the upfront fee to derive the transaction price. This financing component was recorded as a liability at its net present value of approximately $ 57.9 million using a 6.4 % discount rate. Interest expense is being accreted on such liability over the expected commitment period and adjusted for timing of expected cost share payments. Interest expense accreted during the three months ended September 30, 2022 and 2021 was no ne and $ 0.8 million, respectively, and for the nine months ended September 30, 2022 and 2021 was $ 0.7 million and $ 1.9 million, respectively. Through September 30, 2022, Lilly billed us $ 12.4 million for our share of development costs under this agreement, and the amount was fully paid as of September 30, 2022. As of September 30, 2022 and December 31, 2021, the outstanding financing liability to Lilly was $ 48.9 million and $ 60.7 million, respectively, and included within other long-term liabilities, current portion, and other long-term liabilities in the condensed balance sheet.
12
Table of Contents
We allocated the net transaction price of $ 67.1 million to each performance obligation based on our best estimate of its relative standalone selling price using the adjusted market assessment approach. We concluded that the license rights over the non-CNS penetrant IP represents functional IP that is not expected to change over time, and we have no ongoing or undelivered obligations relative to such IP that Lilly will benefit from the use of such IP on the delivery date. As such, the transaction price allocated to the non-CNS penetrant IP of $ 60.4 million was recognized as revenue during the first quarter of 2021 upon delivery of the non-CNS penetrant IP to Lilly in March 2021. For the delivery of license rights over the CNS penetrant IP, we were obligated to perform additional research and development efforts before Lilly can accept the license. The allocated transaction price to the CNS penetrant IP of $ 6.7 million was recognized as revenue from the effective date of the Lilly Agreement through the eventual acceptance by Lilly using the input method. In June 2022, Lilly provided notice of continuance pursuant to the terms of the Lilly Agreement, whereby Lilly elected its option to lead the identification and selection of CNS penetrant lead candidate. As such, we recognized the remaining outstanding deferred revenue related to delivery of the CNS penetrant IP in the second quarter of 2022. For the three months ended September 30, 2022 and 2021, revenue recognized related to activities associated with the delivery of CNS penetrant IP was no ne and $ 2.4 million, respectively, and $ 0.5 million and $ 6.0 million for the nine months ended September 30, 2022 and 2021, respectively.
The remaining future variable consideration related to future milestone payments as discussed above were fully constrained because we cannot conclude that it is probable that a significant reversal of the amount of cumulative revenue recognized will not occur, given the inherent uncertainty of success with these future milestones. For sales-based milestones and royalties, we determined that the license is the predominant item to which the royalties or sales-based milestones relate. Accordingly, we will recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). We will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.
Grifols License Agreement
In January 2019, we entered into an exclusive license agreement with Grifols to commercialize fostamatinib in all indications, including chronic ITP and AIHA, in Europe and Turkey. Under the agreement, we received an upfront payment of $ 30.0 million, with the potential for $ 297.5 million in total regulatory and commercial milestones. We are also entitled to receive stepped double-digit royalty payments based on tiered net sales which may reach 30 % of net sales. In return, Grifols received exclusive rights to commercialize fostamatinib for human diseases, including chronic ITP, AIHA, and IgAN, in Europe and Turkey. Grifols also has the exclusive option to expand the territory under its exclusive and non-exclusive licenses to include the Middle East, North Africa and Russia (including Commonwealth of Independent States). In November 2020, Grifols exercised its option to include these territories as part of the licensed territories under the agreement. The agreement also required us to continue to conduct our long-term open-label extension study on patients with ITP through European Medicines Agency (EMA) approval of ITP in Europe or until the study ends as well as conduct the Phase 3 trial of fostamatinib in AIHA.
We entered into a Commercial Supply Agreement with Grifols in October 2020 to supply and sell our drug product priced at a certain markup specified in the agreement, in quantities Grifols shall order from us pursuant to and in accordance with the agreement.
In January 2020, the European Commission granted a centralized Marketing Authorization (MA) for fostamatinib valid throughout the European Union and in the UK after the departure of the UK from the European Union for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments. With this approval, in February 2020, we received $ 20.0 million non-refundable payment, comprised of a $ 17.5 million payment due upon Marketing Authorization Application (MAA) approval by the EMA of fostamatinib for the first indication and a $ 2.5 million creditable advance royalty payment, based on the terms of our collaboration agreement with Grifols. The above milestone payment was allocated to the distinct performance obligations in the collaboration agreement with Grifols.
13
Table of Contents
We accounted for this agreement under ASC 606 and identified the following distinct performance obligations at inception of the agreement: (a) granting of the license, (b) performance of research and regulatory services related to our ongoing long-term open-label extension study on patients with ITP, and (c) performance of research services related to our Phase 3 study in AIHA. In October 2020, we entered into a commercial supply agreement for the licensed territories. We concluded each of these performance obligations is distinct. We based our assessment on the following: (i) our assessment that Grifols can benefit from the license on its own by developing and commercializing the underlying product using its own resources, and (ii) the fact that the manufacturing services are not highly specialized in nature and can be performed by other vendors. Upon execution of our agreement with Grifols, we determined that the upfront fee of $ 5.0 million, which is the non-refundable portion of the $ 30.0 million upfront fee, represented the transaction price. In the first quarter of 2020, we revised the transaction price to include the $ 25.0 million of the upfront payment that is no longer refundable under our agreement and the $ 20.0 million payment received that is no longer constrained. We allocated the updated transaction price to the distinct performance obligations in our collaboration agreement based on our best estimate of the relative standalone selling price as follows: (a) for the license, we estimated the standalone selling price using the adjusted market assessment approach to estimate its standalone selling price in the licensed territories; (b) for the research and regulatory services, we estimated the standalone selling price using the cost plus expected margin approach. As a result of the adjusted transaction price, adjustments are recorded on a cumulative catch-up basis, and recorded as part of contract revenues from collaborations in the first quarter of 2020.
We recognized revenue associated with the remaining outstanding deferred revenue from research and development services of $ 0.2 million each for the three months ended September 30, 2022 and 2021, and $ 0.7 million and $ 0.6 million, for the nine months ended September 30, 2022 and 2021, respectively. In addition, we recognized revenue for the delivery of fostamatinib to Grifols of $ 0.4 million and none for the three months ended September 30, 2022 and 2021, respectively, and $ 1.6 million and $ 1.0 million, for the nine months ended September 30, 2022 and 2021, respectively.
During the three and nine months ended September 30, 2022, we recognized $ 0.1 million of initial royalty revenue from Grifols, and such amount was included within contract revenues from collaboration. No such revenue was recognized during the same periods in 2021.
The remaining future variable consideration of $ 277.5 million related to future regulatory and commercial milestones were fully constrained because we cannot conclude that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur, given the inherent uncertainty of success with these future milestones. We are recognizing revenues related to the research and regulatory services throughout the term of the respective clinical programs using the input method. For sales-based milestones and royalties, we determined that the license is the predominant item to which the royalties or sales-based milestones relate. Accordingly, we will recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). We will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.
Kissei License Agreement
In October 2018, we entered into an exclusive license and supply agreement with Kissei to develop and commercialize fostamatinib in all current and potential indications in Japan, China, Taiwan and the Republic of Korea. Kissei is responsible for performing and funding all development activities for fostamatinib in the above-mentioned territories. We received an upfront cash payment of $ 33.0 million, with the potential for up to an additional $ 147.0 million in development, regulatory and commercial milestone payments, and will receive mid- to upper twenty percent, tiered, escalated net sales-based payments for the supply of fostamatinib. Under the agreement, we granted Kissei the license rights to fostamatinib in the territories above and are obligated to supply Kissei with drug product for use in clinical trials and pre-commercialization activities. We are also responsible for the manufacture and supply of fostamatinib for all future development and commercialization activities under the agreement.
We accounted for this agreement under ASC 606 and identified the following distinct performance obligations at inception of the agreement: (a) granting of the license, (b) supply of fostamatinib for clinical use and (c) material right associated with discounted fostamatinib that is supplied for use other than clinical or commercial. In addition, we will provide commercial product supply if the product is approved in the licensed territory. We concluded that each of these
14
Table of Contents
performance obligations is distinct. We based our assessment on the following: (i) our assessment that Kissei can benefit from the license on its own by developing and commercializing the underlying product using its own resources and (ii) the fact that the manufacturing services are not highly specialized in nature and can be performed by other vendors. Moreover, we determined that the upfront fee of $ 33.0 million represented the transaction price and was allocated to the performance obligations based on our best estimate of the relative standalone selling price as follows: (a) for the license, we estimated the standalone selling price using the adjusted market assessment approach to estimate its standalone selling price in the licensed territories; (b) for the supply of fostamatinib and the material right associated with discounted fostamatinib, we estimated the standalone selling price using the cost plus expected margin approach. Variable consideration of $ 147.0 million related to future development and regulatory milestones was fully constrained because we cannot conclude that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur, given the inherent uncertainty of success with these future milestones. We will recognize revenues related to the supply of fostamatinib and material right upon delivery of fostamatinib to Kissei. For sales-based milestones and royalties, we determined that the license is the predominant item to which the royalties or sales-based milestones relate to. Accordingly, we will recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). We will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.
As of September 30, 2022 and December 31, 2021, the remaining deferred revenue was related to the material right associated with discounted fostamatinib supply which amounted to $ 1.4 million. No material revenue was recognized during the three and nine months ended September 30, 2022 and 2021 associated with such outstanding deferred revenue.
During the three and nine months ended September 30, 2022, we recognized an immaterial amount of revenue and $ 2.6 million of revenue, respectively, related to the delivery of fostamatinib supply to Kissei mainly for commercial use. No such revenue was recognized during the same periods in 2021.
In April 2022, Kissei announced that a new drug application was submitted to Japan’s Pharmaceuticals and Medical Devices Agency for fostamatinib in chronic ITP. With this milestone event, we received $ 5.0 million non-refundable and non-creditable payment from Kissei pursuant to the terms of our collaboration agreement. Such amount was recognized as revenue in the second quarter of 2022 .
Medison Commercial and License Agreements
In October 2019, we entered into two exclusive commercial and license agreements with Medison for the commercialization of fostamatinib for chronic ITP in Israel and in Canada, pursuant to which we received a $ 5.0 million upfront payment with respect to the agreement in Canada. We accounted for this agreement under ASC 606 and identified the following combined performance obligations at inception of the agreement: (a) granting of the license and (b) obtaining regulatory approval in Canada of fostamatinib in ITP. We determined that the non-refundable upfront fee of $ 5.0 million represented the transaction price. However, under the agreement, we have the option to buy back all rights to the product in Canada within six months from obtaining regulatory approval for the treatment of AIHA in Canada. The buyback option precludes us from transferring control of the license to Medison under ASC 606. We believe that the buyback provision, if exercised, will require us to repurchase the license at an amount equal to or more than the upfront $ 5.0 million. As such, this arrangement was accounted for as a financing arrangement. Interest expense is being accreted on such liability over the expected buyback period. No interest was accreted during the three and nine months ended September 30, 2022. During the three and nine months ended September 30, 2021, we accrued interest amounting to $ 0.1 million and $ 0.4 million, respectively, related to this financing arrangement. As of September 30, 2022 and December 31, 2021, the outstanding financing liability to Medison of $ 5.7 million and $ 5.6 million, respectively, was included within other long-term liabilities in the condensed balance sheet.
Knight Commercial License and Supply Agreement
In May 2022, we entered into commercial license and supply agreements with Knight for the commercialization of fostamatinib for approved indications in Knight territory. Pursuant to such commercial license agreement, we received a $ 2.0 million one-time, non-refundable, and non-creditable upfront payment, with potential for up to an additional $ 20.0 million in regulatory and sales-based commercial milestone payments, and will receive twenty- to mid-thirty percent,
15
Table of Contents
tiered, escalated net-sales based royalty payments for products sold in the Knight territory. We accounted for this agreement under ASC 606 and identified that the upfront payment was a consideration for granting Knight the license to commercialize fostamatinib for approved indication in the Knight territory, and no further material deliverables associated to such upfront payment. As such, we recognized the upfront payment as revenue during the second quarter of 2022. Variable consideration related to future regulatory milestones was fully constrained because we cannot conclude that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur, given the inherent uncertainty of success with these future milestones. For sales-based milestones and royalties, we determined that the license is the predominant item to which the royalties or sales-based milestones relate to. Accordingly, we will recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all the royalty has been allocated has been satisfied (or partially satisfied). We will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur. We are also responsible for the exclusive manufacture and supply of fostamatinib for all future development and commercialization activities under agreement.
Other license agreements
In February 2021, we entered into a non-exclusive license agreement with an unrelated third party whereby we granted such unrelated third party rights to a certain patent. In consideration for the license rights granted, we received a one-time fee of $ 4.0 million. All the deliverables under the agreement had been delivered and the one-time fee was recognized as revenue during the first quarter of 2021.
Government Contract - US Department of Defense’s JPEO-CBRND
In January 2021, we were awarded up to $ 16.5 million by the US Department of Defense to support our ongoing Phase 3 clinical trial to evaluate the safety and efficacy of fostamatinib for the treatment of hospitalized high-risk patients with COVID-19. The amount of award we will receive from the US Department of Defense is subject to submission of proper documentation as evidence of completion of certain clinical trial events or milestones as specified in the agreement, and approval by the US Department of Defense that such events or milestones have been met. We determined that this government award should be accounted for under IAS 2, Accounting for Government Grants and Disclosure of Government Assistance, which is outside of the scope of Topic 606, as the US Department of Defense is not receiving reciprocal value for their contributions. We record government contract revenue in the statement of operations in the period when it is probable that we will receive the award, which is when we comply with the conditions associated with the award and obtain approval from the US Department of Defense that such conditions have been met. For the three and nine months ended September 30, 2022, we recognized $ 2.5 million of revenue related to this grant. For the three and nine months ended September 30, 2021, we recognized $ 1.0 million and $ 9.5 million of revenue, respectively, related to this grant. Through September 30, 2022, we recognized $ 13.0 million revenue and we expect to receive the remaining award of $ 3.5 million throughout the period we conduct our clinical trial, subject to us meeting certain clinical trial events or milestones and approval by the US Department of Defense as specified in the agreement.
License and Transition Services Agreement with Forma
On July 27, 2022, we entered into a license and transition services agreement with Forma for an exclusive license to develop, manufacture and commercialize olutasidenib, Forma’s proprietary inhibitor of mIDH1, for any uses worldwide, including for the treatment of AML and other malignancies. Pursuant to the terms of the license and transition services agreement, we paid Forma an upfront fee of $ 2.0 million, with the potential to pay up to $ 67.5 million of additional payments upon achievement of specified development and regulatory milestones and up to $ 165.5 million of additional payments upon achievement of certain commercial milestones. The potential development and regulatory milestone payments of $ 67.5 million include a $ 2.5 million payment upon achievement of a certain near-term regulatory milestone, a $ 5.0 million payment upon the first regulatory approval of the licensed product, and $ 10.0 million payment upon the licensed product’s first commercial sale subject to certain other conditions. In addition, subject to the terms and conditions of the license and transition services agreement, Forma would be entitled to tiered royalty payments on net sales of licensed products at percentages ranging from low-teens to mid-thirties, as well as certain portion of our sublicensing revenue, subject to certain standard reductions and offsets.
16
Table of Contents
Forma has submitted an NDA for olutasidenib for the treatment of m1DH1 relapsed/refractory (R/R) AML to the FDA and the Prescription Drug User Fee Act (PDUFA) action date for the application is February 15, 2023.
The transaction was accounted for as an acquisition of asset under ASC 730, Research and Development . In accordance with the guidance, in a transaction accounted for as an asset acquisition, any acquired in-process research and development (IPR&D) that does not have alternative future use is charged to expense at the acquisition date. At the acquisition date, the acquired license asset was accounted for as IPR&D, and we do not anticipate any economic benefit to be derived from such acquired licensed asset other than the primary indications. As such, we accounted for the upfront fee of $ 2.0 million paid to Forma as IPR&D and recorded such cost within research and development expenses in the condensed statements of operations for the three and nine months ended September 30, 2022.
Under the accounting guidance, contingent cash payments will be accrued when it is probable that a liability has been incurred and the amount can be reasonably estimated. We will account for m ilestone payment obligations incurred at development stage and prior to a regulatory approval of an indication associated with the acquired licensed asset as research and development expenses when the event requiring payment of the milestone occurs. Milestone payment obligations incurred upon and after a regulatory approval of an indication associated with the acquired licensed asset, and at the commercial stage, will be recorded as intangible asset when the event requiring payment of the milestones occurs. The amount recorded as intangible asset will be amortized over the estimated useful life of the acquired licensed asset. Royalty payments related to the acquired licensed asset will be recorded as cost of sales when incurred. As of September 30, 2022, no milestone payment was met. In October 2022, the near-term regulatory milestone was met which entitles Forma to receive a $ 2.5 million milestone payment. Since such milestone payment obligation was incurred prior to a regulatory approval of an indication associated with the acquired licensed asset, we will record such amount as research and development expense in the fourth quarter of 2022.
5.
Stock-Based Compensation
Stock-based compensation for the periods presented was as follows (in thousands):
Three Months Ended September 30,
Nine Months Ended September 30,
2022
2021
2022
2021
Selling, general and administrative
$
2,119
$
1,800
$
6,791
$
5,625
Research and development
588
402
1,514
1,522
Total stock-based compensation expense
$
2,707
$
2,202
$
8,305
$
7,147
In March 2022, our Board of Directors approved to extend the exercise period of the stock option grants made to our two former Board of Directors whose terms expired in May 2022. As a result of this modification, we recorded an incremental stock-based compensation expense of approximately $ 0.8 million in the first quarter of 2022. The amount was included within selling, general and administrative expense in the condensed statement of operations.
During the nine months ended September 30, 2022, we granted stock options to purchase 5,523,247 shares of common stock with weighted-average grant-date fair value of $ 1.60 per share, and 433,318 stock options were exercised. As of September 30, 2022, there were 32,686,792 stock options outstanding, of which, 2,535,000 are outstanding performance-based stock options wherein the achievement of the corresponding corporate-based milestones were not considered probable as of September 30, 2022. Accordingly, none of the $ 5.0 million grant date fair value for these awards has been recognized as stock-based compensation expense through September 30, 2022.
The fair value of each option award is estimated on the date of grant using the Black-Scholes option pricing model. The following table summarizes the weighted-average assumptions relating to options granted pursuant to our Equity Incentive Plans (2018 Equity Incentive Plan and Inducement Plan) for the periods presented:
Three Months Ended September 30,
Nine Months Ended September 30,
2022
2021
2022
2021
Risk-free interest rate
3.0
%
1.1
%
1.9
%
1.0
%
Expected term (in years)
6.1
6.0
6.5
6.5
Dividend yield
0.0
%
0.0
%
0.0
%
0.0
%
Expected volatility
80.9
%
70.4
%
70.5
%
70.6
%
17
Table of Contents
During the nine months ended September 30, 2022, we granted 1,181,362 restricted stock units (RSUs) with a grant-date weighted-average fair value of $ 2.36 per share, and 203,750 RSUs were released. The RSUs granted generally vest over 4 years . As of September 30, 2022, there were 1,174,232 RSUs outstanding.
As of September 30, 2022, there was approximately $ 15.8 million of unrecognized stock-based compensation which is expected to be recognized over a remaining weighted-average period of 2.75 years related to time-based stock options, RSUs and performance-based stock options where achievement of the corresponding corporate-based milestones was considered probable as of September 30, 2022.
In January 2022 and April 2022, our Board of Directors approved the increase of 610,000 shares and 626,000 shares, respectively, of common stock reserved for issuance under the Inducement Plan. In May 2022 at the annual stockholders meeting, our stockholders approved to amend our 2018 Equity Incentive Plan (2018 Plan), among other items, added an additional 5,000,000 shares to the number of shares of common stock authorized for issuance under the 2018 Plan. As of September 30, 2022, there were 12,353,820 shares of common stock available for future grant under our Equity Incentive Plans.
Employee Stock Purchase Plan
Our Purchase Plan permits our eligible employees to purchase common stock at a discount through payroll deductions during the offering period. Our Purchase Plan provides for a twenty-four -month offering period comprised of four six-month purchase periods with a look-back option. A look-back option is a provision in our Purchase Plan under which eligible employees can purchase shares of our common stock at a price per share equal to the lesser of 85 % of the fair market value on the first day of the offering period or 85 % of the fair market value on the purchase date. Our Purchase Plan also includes a feature that provides for a new offering period to begin when the fair market value of our common stock on any purchase date during an offering period falls below the fair market value of our common stock on the first day of such offering period. This feature is called a “reset.” Participants are automatically enrolled in the new offering period.
Our previous twenty-four -month offering period under our Purchase Plan ended on June 30, 2022, and a new twenty-four-month offering period started on July 1, 2022. The fair value of awards under our Purchase Plan is estimated on the date of our new offering period using the Black-Scholes option pricing model, which is being amortized over the requisite service periods. As of September 30, 2022, unrecognized stock-based compensation cost related to our Purchase Plan amounted to $ 1.4 million, which is expected to be recognized over the remaining weighted average period of 0.99 years.
During the nine months ended September 30, 2022, there were 597,042 shares purchased under the Purchase Plan. As of September 30, 2022, there were 3,987,442 shares reserved for future issuance under the Purchase Plan.
6.
Inventories
Inventories for the periods presented consist of the following (in thousands):
September 30,
December 31,
2022
2021
Raw materials
$
4,555
$
5,142
Work in process
1,244
162
Finished goods
1,317
1,312
Total
$
7,116
$
6,616
As of September 30, 2022, we have $ 0.7 million in advance payments to the manufacturer of our raw materials, which was included within prepaid and other current assets in the condensed balance sheet.
18
Table of Contents
7. Cash, Cash Equivalents and Short-Term Investments
Cash, cash equivalents and short-term investments for the periods presented consist of the following (in thousands):
September 30,
December 31,
2022
2021
Cash
$
3,705
$
6,249
Money market funds
8,084
6,842
US treasury bills
17,160
35,366
Government-sponsored enterprise securities
23,898
14,678
Corporate bonds and commercial paper
28,795
61,832
$
81,642
$
124,967
Reported as:
Cash and cash equivalents
$
29,866
$
18,890
Short-term investments
51,776
106,077
$
81,642
$
124,967
Cash equivalents and short-term investments include the following securities with gross unrealized gains and losses (in thousands):
Gross
Gross
Amortized
Unrealized
Unrealized
September 30, 2022
Cost
Gains
Losses
Fair Value
US treasury bills
$
17,272
$
—
$
( 112 )
$
17,160
Government-sponsored enterprise securities
24,017
4
( 123 )
23,898
Corporate bonds and commercial paper
28,850
—
( 55 )
28,795
Total
$
70,139
$
4
$
( 290 )
$
69,853
Gross
Gross
Amortized
Unrealized
Unrealized
December 31, 2021
Cost
Gains
Losses
Fair Value
US treasury bills
$
35,416
$
—
$
( 50 )
$
35,366
Government-sponsored enterprise securities
14,705
—
( 27 )
14,678
Corporate bonds and commercial paper
61,857
2
( 27 )
61,832
Total
$
111,978
$
2
$
( 104 )
$
111,876
As of September 30, 2022 and December 31, 2021, our cash equivalents and short-term investments had a weighted-average time to maturity of approximately 105 days and 196 days , respectively. Our short-term investments are classified as available-for-sale securities. Accordingly, we have classified certain securities as short-term investments on our condensed balance sheets as they are available for use in the current operations. As of September 30, 2022, we had no investments that had been in a continuous unrealized loss position for more than 12 months. As of September 30, 2022, a total of 36 individual securities had been in an unrealized loss position for 12 months or less, and the losses were determined to be temporary. The gross unrealized losses above were caused by interest rate increases. No significant facts or circumstances have arisen to indicate that there has been any significant deterioration in the creditworthiness of the issuers of the securities held by us. Based on our review of these securities, including our assessment of the duration and severity of unrealized losses, there were no other-than-temporary impairments for these securities as of September 30, 2022.
19
Table of Contents
The following table shows the fair value and gross unrealized losses of our investments in individual securities that are in an unrealized loss position, aggregated by investment category (in thousands):
September 30, 2022
Fair Value
Unrealized Losses
US treasury bills
$
17,160
$
( 112 )
Government-sponsored enterprise securities
14,239
( 123 )
Corporate bonds and commercial paper
28,795
( 55 )
Total
$
60,194
$
( 290 )
8.
Fair Value
The table below summarizes the fair value of our cash equivalents and short-term investments measured at fair value on a recurring basis, and are categorized based upon the lowest level of significant input to the valuations (in thousands):
Assets at Fair Value as of September 30, 2022
Level 1
Level 2
Level 3
Total
Money market funds
$
8,084
$
—
$
—
$
8,084
US treasury bills
—
17,160
—
17,160
Government-sponsored enterprise securities
—
23,898
—
23,898
Corporate bonds and commercial paper
—
28,795
—
28,795
Total
$
8,084
$
69,853
$
—
$
77,937
Assets at Fair Value as of December 31, 2021
Level 1
Level 2
Level 3
Total
Money market funds
$
6,842
$
—
$
—
$
6,842
US treasury bills
—
35,366
—
35,366
Government-sponsored enterprise securities
—
14,678
—
14,678
Corporate bonds and commercial paper
—
61,832
—
61,832
Total
$
6,842
$
111,876
$
—
$
118,718
9. Debt
We have a Credit and Security Agreement (Credit Agreement) with MidCap Financial Trust (MidCap) entered on September 27, 2019 (Closing Date) and amended on March 29, 2021 (First Amendment), February 11, 2022 (Second Amendment) and July 27, 2022 (Third Amendment). The Credit Agreement provides for a $ 60.0 million term loan credit facility. At the Closing Date, $ 10.0 million was funded (Tranche 1), in May 2020, an additional $ 10.0 million was funded (Tranche 2), at the Second Amendment, an additional $ 10.0 million was funded (Tranche 3), and at the Third Amendment, an additional $ 10.0 million was funded (Tranche 4). As of September 30, 2022, the outstanding principal balance of the loan was $ 40.0 million, and the facility gives us the ability to access an additional $ 20.0 million aggregate principal amount of term loan at our option through March 31, 2023 (Tranche 5).
The First Amendment to the Credit Agreement entered in March 2021 extended the period through which Tranche 3 was available to us. The Second Amendment to the Credit Agreement entered in February 2022, among other things, amended the applicable funding conditions, applicable commitments and certain other terms relating to available credit facilities (Tranches 3 and 4), added additional term loan credit facility (Tranche 5), and revised certain terms related to the financial covenants.
Prior to the Third Amendment, the outstanding principal balance of the loan bore interest at an annual rate of one-month London Interbank Offered Rate (LIBOR), or a comparable applicable index rate determined pursuant to the Credit Agreement if the LIBOR is no longer available, plus applicable margin of 5.65 % , subject to a LIBOR floor of 1.50 % and is payable monthly in arrears. Further, the Credit Agreement provided for an interest-only payment period of 24 months from October 1, 2019, followed by 36 months of amortization payments. The interest-only period can also be extended to 36 months (first interest-only extension) and again to 48 months (second interest-only extension) upon the satisfaction of certain conditions set forth in the Credit Agreement. In June 2021 and June 2022, we satisfied the first and second interest-only extension conditions, respectively, which effectively extended the interest-only period through
20
Table of Contents
October 1, 2023. All unpaid principal and accrued interest were due and payable no later than September 1, 2024, and a final payment fee of 2.5 % of principal was due on the final payment of the term loan.
Following the Third Amendment, the maturity date for the term loans was extended to September 1, 2026, and the interest-only period was extended to October 1, 2024. Further, the interest rate benchmark was changed from LIBOR to Secured Overnight Financing Rate (SOFR). The interest rate applicable to the term loans under the amended Credit Agreement is the sum of one-month SOFR, plus an adjustment of 0.11448% , subject to 1.50 % applicable floor, plus applicable margin of 5.65 % . A final payment fee of 2.5 % of principal is due at maturity date of the term loans.
U nder the amended Credit Agreement, the prepayment fee applicable to the term loans was reset at the Third Amendment date. We may make voluntary prepayments, in whole or in part, subject to certain prepayment premiums and additional interest payments. The Credit Agreement also contains certain provisions, such as event of default and change in control provisions, which, if triggered, would require us to make mandatory prepayments on the term loan, which are subject to certain prepayment premiums and additional interest payments. The obligations under the amended Credit Agreement are secured by a perfected security interest in all of our assets including our intellectual property.
The amendment to the Credit Agreement was accounted for as debt modification. As such, fees paid to Midcap of $ 0.4 million were recorded as additional debt discount and added to the unamortized debt discount that are being amortized as interest expense through maturity using the effective interest rate method. Debt issuance costs are recorded as a direct deduction from the outstanding principal balance of the term loan. As of September 30, 2022 and December 31, 2021, the unamortized issuance costs and debt discounts amounted to $ 0.5 million and $ 0.1 million, respectively. As of September 30, 2022 and December 31, 2021, the outstanding balance of the loan, net of unamortized debt discount was classified as long-term liability in the accompanying condensed balance sheet.
Interest expense, including amortization of the debt discount and accretion of the final fees related to the Credit Agreement for the three months ended September 30, 2022 and 2021 was $ 0.8 million and $ 0.4 million, respectively, and for the nine months ended September 30, 2022 and 2021 was $ 1.9 million and $ 1.2 million, respectively. Accrued interest of $ 0.7 million was included within other accrued liabilities in the condensed balance sheet as of September 30, 2022.
The following table presents the future minimum principal payments of the outstanding loan as of September 30, 2022 (in thousands):
Remainder of 2022
$
—
2023
—
2024
5,000
2025
20,000
2026
15,000
Principal amount (Tranches 1, 2, 3 and 4)
$
40,000
The amended Credit Agreement contains certain covenants which, among others, require us to deliver financial reports at designated times of the year and maintain minimum unrestricted cash and trailing net revenues. As of September 30, 2022, we were not in violation of any covenants.
21
Table of Contents
10. Leases
We currently lease our research and office space under a noncancelable lease agreement with our landlord, Healthpeak Properties, Inc. (formerly known as HCP BTC, LLC), which originally set to expire in 2018, and was extended in July 2017 for another five years through January 2023. In March 2022, we entered an amendment to the lease agreement to waive our option or right to further extend the term of the lease. The weighted average remaining term of our lease as of September 30, 2022 was 0.33 years. On October 28, 2022, we entered into a sublease agreement. See further discussions in Note 12 - Subsequent Events.
We have a sublease agreement originally entered in December 2014, and subsequently amended in February 2017 and July 2017, with an unrelated third party to occupy a portion of our research and office space which expire in January 2023.
As of September 30, 2022, we received from our landlord leasehold improvement incentives amounting to $ 0.7 million related to leasehold improvements. We record these leasehold improvement incentives as a reduction to operating lease right-of-use asset and lease liability until the lease ends and the asset is transferred.
We recorded rent expense on a straight-line basis for our lease, net of sublease income. For our sublease arrangement which we classified as an operating lease, our loss on the sublease was comprised of the present value of our future payments to our landlord less the present value of our future rent payments expected from our subtenant over the term of the sublease.
The components of our operating lease expense were as follows (in thousands):
Three Months Ended September 30,
Nine Months Ended September 30,
2022
2021
2022
2021
Fixed operating lease expense
$
1,340
$
1,340
$
4,020
$
4,020
Variable operating lease expense
211
259
602
651
Total operating lease expense
$
1,551
$
1,599
$
4,622
$
4,671
Supplemental information related to our operating lease were as follow (in thousands):
Three Months Ended September 30,
Nine Months Ended September 30,
2022
2021
2022
2021
Cash payments included in the measurement of operating lease liabilities
$
2,630
$
2,529
$
7,856
$
7,554
Supplemental information related to our operating sublease was as follow (in thousands):
Three Months Ended September 30,
Nine Months Ended September 30,
2022
2021
2022
2021
Fixed sublease expense
$
1,095
$
1,095
$
3,285
$
3,285
Variable sublease expense
232
236
682
680
Sublease income
( 1,327 )
( 1,331 )
( 3,967 )
( 3,965 )
Net
$
—
$
—
$
—
$
—
The following table presents the future lease payments of our operating lease liabilities as of September 30, 2022 (in thousands):
Operating Lease
Sublease Receipts
Net
Remainder of 2022
$
2,630
( 1,183 )
1,447
2023
877
( 394 )
483
Total minimum payments required
$
3,507
$
( 1,577 )
$
1,930
22
Table of Contents
11. Income Taxes
For the three and nine months ended September 30, 2022, we did no t recognize provision for income taxes due to our pre-tax book loss as we continue to record a full valuation allowance on our deferred tax assets considering our cumulative losses in prior years and forecasted losses in the future. For the three and nine months ended September 30, 2021, we recorded a benefit from income tax of $ 0.1 million and a provision for income tax of $ 0.7 million, respectively. The benefit from and the provision for income tax for the three and nine months ended September 30, 2021 were determined using our effective tax rate on our year-to-date income (loss). We estimated a state tax liability over our pre-tax income (loss) for 2021, which was primarily due to revenue recognized for the Lilly Agreement. We did not estimate a provision for federal income taxes due to the sufficient net operating loss carryforwards that were generated prior to enactment of the Tax Cuts and Jobs Act, as well as our ability to utilize significant research and development credit carryforwards.
12. Subsequent Events
Restructuring
On October 10, 2022, we announced a reduction in our workforce primarily in our development and administration groups. All affected employees will be eligible to receive, among other things, specified severance payments based on the applicable employee’s level and years of service with us. We expect to complete the workforce reduction by January 31, 2023. We recognize restructuring charges when the liability is probable, and the amount is estimable. The related employee termination benefits are accrued at the date management has committed to a plan of termination and affected employees have been notified of their termination date and expected severance benefits. As such, we expect to recognize the restructuring charges in the fourth quarter of 2022.
Sublease Agreement
On October 28, 2022, we entered into a sublease agreement with Atara Biotherapeutics, Inc. (Atara) to sublease approximately 13,670 rentable square feet of office space located in South San Francisco, California. Subject to the terms of the sublease agreement, the lease term shall commence no sooner than November 1, 2022 and shall expire on May 24, 2025. The future lease payments associated with this sublease agreement are approximately $ 1.7 million. We expect this new leased facility will be held as our new Headquarters following the expiration of our current leased facility in South San Francisco, California in January 2023. In accordance with ASC 842, Leases, we expect to recognize the operating lease right-of-use asset and lease liability associated with this sublease agreement in the fourth quarter of 2022.
23
Table of Contents
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.