Item 1. Financial Statements
Item 1. Financial Statements
ASSEMBLY BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands except for share amounts and par value)
June 30,
December 31,
2020
2019
(Unaudited)
ASSETS
Current assets
Cash and cash equivalents
$
96,709
$
46,732
Marketable securities
130,005
227,311
Accounts receivable from collaboration
3,315
3,374
Prepaid expenses and other current assets
5,059
5,363
Total current assets
235,088
282,780
Property and equipment, net
2,063
1,830
Operating lease right-of-use (ROU) assets
10,780
11,975
Other assets
5,232
1,684
Indefinite-lived intangible asset
29,000
29,000
Goodwill
12,638
12,638
Total assets
$
294,801
$
339,907
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Accounts payable
$
3,640
$
1,731
Accrued clinical expenses
4,362
4,826
Other accrued expenses
6,019
8,286
Deferred revenue - short-term
—
6,411
Operating lease liabilities - short-term
3,250
3,186
Total current liabilities
17,271
24,440
Deferred tax liabilities
2,531
2,531
Deferred revenue - long-term
—
30,637
Operating lease liabilities - long-term
7,884
9,082
Total liabilities
27,686
66,690
Commitments and contingencies
Stockholders' equity
Preferred stock, $ 0.001 par value; 5,000,000 shares authorized; no shares issued or outstanding
—
—
Common stock, $ 0.001 par value; 100,000,000 shares authorized as of June 30, 2020 and December 31, 2019; 32,807,519 and 32,558,307 shares issued and outstanding as of June 30, 2020 and December 31, 2019, respectively
33
32
Additional paid-in capital
725,784
712,807
Accumulated other comprehensive income (loss)
104
( 201
)
Accumulated deficit
( 458,806
)
( 439,421
)
Total stockholders' equity
267,115
273,217
Total liabilities and stockholders' equity
$
294,801
$
339,907
See Accompanying Notes to Condensed Consolidated Financial Statements
1
ASSEMBLY BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
(In thousands except for share and per share amounts)
(Unaudited)
Three Months Ended June 30,
Six Months Ended June 30,
2020
2019
2020
2019
Collaboration revenue
$
39,376
$
3,080
$
43,457
$
6,966
Operating expenses:
Research and development
23,327
18,700
46,373
41,405
General and administrative
9,470
4,080
18,199
13,597
Total operating expenses
32,797
22,780
64,572
55,002
Income (loss) from operations
6,579
( 19,700
)
( 21,115
)
( 48,036
)
Other income
Interest and other income, net
691
1,186
1,730
2,463
Total other income
691
1,186
1,730
2,463
Income (loss) before income taxes
7,270
( 18,514
)
( 19,385
)
( 45,573
)
Income tax benefit
—
11
—
18
Net income (loss)
$
7,270
$
( 18,503
)
$
( 19,385
)
$
( 45,555
)
Other comprehensive income
Unrealized gain on marketable securities, net of tax
190
52
305
160
Comprehensive income (loss)
$
7,460
$
( 18,451
)
$
( 19,080
)
$
( 45,395
)
Net income (loss) per share, basic
$
0.21
$
( 0.72
)
$
( 0.55
)
$
( 1.77
)
Weighted average common shares outstanding, basic
35,307,669
25,740,500
35,229,570
25,690,617
Net income (loss) per share, diluted
$
0.19
$
( 0.72
)
$
( 0.55
)
$
( 1.77
)
Weighted average common shares outstanding, diluted
37,291,474
25,740,500
35,229,570
25,690,617
See Accompanying Notes to Condensed Consolidated Financial Statements
2
ASSEMBLY BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
Six Months Ended June 30,
2020
2019
Cash flows from operating activities
Net loss
$
( 19,385
)
$
( 45,555
)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
237
260
Stock-based compensation
12,058
8,645
Net accretion and amortization of investments in marketable debt securities
( 101
)
( 1,141
)
Non-cash rent expense
2,308
2,208
Deferred income tax benefit
—
( 18
)
Loss on disposal of fixed assets
—
102
Other
—
( 5
)
Changes in operating assets and liabilities:
Accounts receivable from collaboration
59
( 473
)
Prepaid expenses and other current assets
304
( 5,068
)
Other assets
( 2,155
)
1,655
Accounts payable
516
( 279
)
Accrued clinical expenses
( 464
)
248
Other accrued expenses
( 2,416
)
( 2,428
)
Deferred revenue
( 37,048
)
( 996
)
Operating lease liabilities
( 2,247
)
( 2,099
)
Net cash used in operating activities
( 48,334
)
( 44,944
)
Cash flows from investing activities
Purchases of property and equipment
( 470
)
( 1,539
)
Purchases of marketable securities
( 44,240
)
( 93,667
)
Proceeds from maturities of marketable securities
119,252
131,591
Proceeds from sale of marketable securities
22,700
500
Net cash provided by investing activities
97,242
36,885
Cash flows from financing activities
Proceeds from the exercise of stock options
602
331
Proceeds from the issuance of common stock under Employee Stock Purchase Plan (ESPP)
467
515
Net cash provided by financing activities
1,069
846
Net increase (decrease) in cash and cash equivalents
49,977
( 7,213
)
Cash and cash equivalents at the beginning of the period
46,732
41,471
Cash and cash equivalents at the end of the period
$
96,709
$
34,258
Supplemental non-cash investing and financing activities
Operating lease liabilities arising from obtaining ROU assets
$
545
$
14,225
See Accompanying Notes to Condensed Consolidated Financial Statements
3
ASSEMBLY BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(In thousands except for share amounts)
(Unaudited)
For the Three Month Period
Common Stock
Additional
Accumulated
Other
Total
Shares
Amount
Paid-in
Capital
Comprehensive
Income (Loss)
Accumulated
Deficit
Stockholders'
Equity
Balance as of March 31, 2020
32,624,725
$
32
$
717,898
$
( 86
)
$
( 466,076
)
$
251,768
Issuance of common stock upon exercise of stock options
74,879
1
482
—
—
483
Issuance of common stock under ESPP
42,266
—
467
—
—
467
Issuance of shares of common stock for settlement of restricted stock units (RSUs)
65,649
—
—
—
—
—
Unrealized gain on marketable debt securities
—
—
—
190
—
190
Stock-based compensation
—
—
6,937
—
—
6,937
Net income
—
—
—
—
7,270
7,270
Balance as of June 30, 2020
32,807,519
$
33
$
725,784
$
104
$
( 458,806
)
$
267,115
Common Stock
Additional
Accumulated
Other
Total
Shares
Amount
Paid-in
Capital
Comprehensive
Loss
Accumulated
Deficit
Stockholders'
Equity
Balance as of March 31, 2019
25,549,757
$
26
$
559,453
$
( 239
)
$
( 368,839
)
$
190,401
Issuance of common stock upon exercise of stock options
29,875
—
191
—
—
191
Issuance of common stock under ESPP
36,804
—
515
—
—
515
Issuance of shares of common stock for settlement of RSUs
30,347
—
—
—
—
—
Unrealized gain on marketable debt securities, net of tax
—
—
—
52
—
52
Stock-based compensation
—
—
2,051
—
—
2,051
Net loss
—
—
—
—
( 18,503
)
( 18,503
)
Balance as of June 30, 2019
25,646,783
$
26
$
562,210
$
( 187
)
$
( 387,342
)
$
174,707
4
For the Six Month Period
Common Stock
Additional
Accumulated
Other
Total
Shares
Amount
Paid-in
Capital
Comprehensive
Income (Loss)
Accumulated
Deficit
Stockholders'
Equity
Balance as of December 31, 2019
32,558,307
$
32
$
712,807
$
( 201
)
$
( 439,421
)
$
273,217
Issuance of common stock upon exercise of stock options
91,713
1
601
—
—
602
Issuance of common stock under ESPP
42,266
—
467
—
—
467
Issuance of shares of common stock for settlement of RSUs
115,233
—
—
—
—
—
Reclassification of stock-based awards from equity to accrued expenses
—
—
—
—
—
—
Unrealized gain on marketable debt securities
—
—
—
305
—
305
Stock-based compensation
—
—
11,909
—
—
11,909
Net loss
—
—
—
—
( 19,385
)
( 19,385
)
Balance as of June 30, 2020
32,807,519
$
33
$
725,784
$
104
$
( 458,806
)
$
267,115
Common Stock
Additional
Accumulated
Other
Total
Shares
Amount
Paid-in
Capital
Comprehensive
Loss
Accumulated
Deficit
Stockholders'
Equity
Balance as of December 31, 2018
25,495,425
$
25
$
552,762
$
( 347
)
$
( 341,787
)
$
210,653
Issuance of common stock upon exercise of stock options
50,875
—
331
—
—
331
Issuance of common stock under ESPP
36,804
—
515
—
—
515
Issuance of shares of common stock for settlement of RSUs
63,679
1
( 1
)
—
—
—
Settlement of RSUs for cash
—
—
( 4
)
—
—
( 4
)
Unrealized gain on marketable debt securities, net of tax
—
—
—
160
—
160
Stock-based compensation
—
—
8,607
—
—
8,607
Net loss
—
—
—
—
( 45,555
)
( 45,555
)
Balance as of June 30, 2019
25,646,783
$
26
$
562,210
$
( 187
)
$
( 387,342
)
$
174,707
See Accompanying Notes to Condensed Consolidated Financial Statements
5
ASSEMBLY BIOSCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Note 1 - Nature of Business
Overview
Assembly Biosciences, Inc., together with its subsidiaries (Assembly or the Company), incorporated in Delaware in October 2005, is a clinical-stage biotechnology company advancing two innovative programs: a novel class of oral therapeutic candidates targeting chronic hepatitis B virus (HBV) infection and a novel class of oral live microbial biotherapeutic candidates, which are designed to treat disorders associated with the microbiome. The Company operates in one segment and is headquartered in South San Francisco, California, with operations in California, Connecticut and China.
The Company’s HBV Cure program is pursuing multiple drug candidates that inhibit the HBV lifecycle and block the generation of covalently closed circular DNA (cccDNA), with the aim of increasing the current low cure rates for patients with chronic HBV infection. Assembly has discovered several novel core inhibitors, which are small molecules that directly target and allosterically modify the HBV core protein.
The Company’s Microbiome program is centered on a fully integrated platform that includes a biological function-based strain isolation, identification, characterization and selection process, methods for strain purification and growth under conditions compliant with current Good Manufacturing Practice (cGMP) requirements. That platform is complemented by a licensed patented delivery system that the Company calls GEMICEL®, which is designed to allow for targeted oral delivery of live biologic and conventional therapies to the lower gastrointestinal (GI) tract. Using the Company’s microbiome platform, the Company is exploring product candidates for multiple disease indications, including ulcerative colitis (UC), Crohn’s disease and irritable bowel syndrome (IBS) in connection with its Research, Development, Collaboration and License Agreement (the Allergan Collaboration Agreement) with Allergan Pharmaceuticals International Limited (Allergan), which was acquired by AbbVie Inc. (AbbVie) in May 2020. In June 2020, AbbVie made a strategic portfolio decision to terminate the Allergan Collaboration Agreement effective on October 10, 2020 (see Note 8). Assembly is also exploring the microbiome in connection with immune-mediated and metabolic disorders and oncology.
Liquidity
The Company has not derived any revenue from product sales to date and currently has no approved products. Once a product has been developed, it will need to be approved for sale by the U.S. Food and Drug Administration (FDA) or an applicable foreign regulatory agency. Since inception, the Company’s operations have been financed primarily through the sale of equity securities, proceeds from the exercise of warrants and stock options, issuance of debt and an upfront payment related to the Allergan Collaboration Agreement. The Company has incurred losses from operations since inception and expects to continue to incur substantial losses for the next several years as it continues its product development efforts. Management believes the Company currently has sufficient funds to meet its operating requirements for at least the next 12 months following the date that these unaudited condensed consolidated interim financial statements are issued. If the Company cannot generate significant cash from its operations, it intends to obtain any additional funding it requires through strategic relationships, public or private equity or debt financings, grants or other arrangements (see Note 6 for recent sales of common stock). The Company cannot assure such funding will be available on reasonable terms, if at all. Market volatility resulting from the global novel coronavirus disease (COVID-19) pandemic or other factors could also adversely impact the Company’s ability to access capital when and as needed.
If the Company is unable to generate sufficient revenue from its collaborations, secure additional sources of funding or receive full and timely collections of amounts due, it may be necessary to significantly reduce the current rate of spending through reductions in staff and delaying, scaling back, or stopping certain research and development programs, including more costly clinical trials.
6
ASSEMBLY BIOSCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Note 2 - Summary of Significant Accounting Policies and Recent Accounting Pronouncements
Basis of Presentation
The accompanying unaudited interim condensed consolidated financial statements include the accounts of the Company and its subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.
The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with the accounting principles generally accepted in the United States of America (U.S. GAAP) for interim financial information and pursuant to the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the U.S. Securities and Exchange Commission (SEC). In management’s opinion, the unaudited interim condensed consolidated financial statements have been prepared on the same basis as the annual audited consolidated financial statements and include normal recurring adjustments necessary for the fair presentation of the Company’s financial position and its results of operations and comprehensive loss and its cash flows for the periods presented. These statements do not include all disclosures required by U.S. GAAP and should be read in conjunction with the Company’s audited consolidated financial statements and accompanying notes for the fiscal year ended December 31, 2019, which are contained in the Company’s Annual Report on Form 10-K as filed with the SEC on March 4, 2020. The results for the three and six months ended June 30, 2020 are not necessarily indicative of results to be expected for the entire year ending December 31, 2020 or future operating periods.
Use of Estimates
The preparation of the unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that may affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. Actual results could differ from those estimates.
Significant estimates inherent in the preparation of the accompanying unaudited condensed consolidated financial statements include revenue recognition, clinical trial accruals, recoverability and useful lives (indefinite or finite) of intangible assets, assessment of impairment of goodwill, provisions for income taxes, amounts receivable and recognized as revenue under the Allergan Collaboration Agreement, measurement of operating lease liabilities, and the fair value of stock options, stock appreciation rights, and restricted stock units (RSUs) granted to employees, directors and consultants.
The Company’s estimates could be affected by external conditions, including those unique to the Company and general economic conditions. It is reasonably possible that these external factors could have an effect on the Company’s estimates and could cause actual results to differ materially from those estimates and assumptions.
Other Risks and Uncertainties
In March 2020, the World Health Organization declared the COVID-19 outbreak a pandemic. To date, the Company’s operations have not been significantly impacted by the COVID-19 pandemic. However, the Company cannot at this time predict the specific extent, duration, or full impact the COVID-19 pandemic will have on its business, operations, strategy, prospects and financial condition and results. The impact of the COVID-19 pandemic on the financial performance of the Company will depend on future developments, including the duration and spread of the outbreak and related governmental advisories and restrictions. These developments and the impact of the COVID-19 pandemic on the financial markets and the overall economy are highly uncertain. If the financial markets and/or the overall economy are impacted for an extended period, the Company’s results may be adversely affected.
Income Taxes
In March 2020, the Families First Coronavirus Response Act (FFCR Act) and the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) were each enacted in response to the COVID-19 pandemic. The FFCR Act and the CARES Act contain numerous income tax provisions relating to refundable payroll tax credits, deferment of employer side social security payments, net operating loss carryback periods, alternative minimum tax credit refunds, modifications to the net interest deduction limitations and technical corrections to tax depreciation methods for qualified improvement property.
7
ASSEMBLY BIOSCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
In June 2020, Assembly Bill 85 (A.B. 85) was signed into California law. A.B. 85 provides for a three-year suspension of the use of net operating losses for medium and large businesses and a three-year cap on the use of business incentive tax credits to offset no more than $ 5.0 million of tax per year. A.B. 85 suspends the use of net operating losses for taxable years 2020, 2021 and 2022 for certain taxpayers with taxable income of $ 1.0 million or more. The carryover period for any net operating losses that are suspended under this provision will be extended. A.B. 85 also requires that business incentive tax credits including carryovers may not reduce the applicable tax by more than $ 5.0 million for taxable years 2020, 2021 and 2022.
The FFCR Act, CARES Act and A.B. 85 did not have a material impact on the Company’s condensed consolidated financial statements as of June 30, 2020; however, the Company continues to examine the impacts the FFCR Act, CARES Act and A.B. 85 may have on its business, results of operations, financial condition and liquidity.
Net Income (Loss) per Share
Basic net income (loss) per common share excludes dilution and is computed by dividing net income (loss) by the weighted average number of common shares outstanding during the period. Diluted net income (loss) per common share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the entity unless inclusion of such shares would be anti-dilutive.
In December 2019, the Company sold 6,287,878 shares of common stock as well as pre-funded warrants to purchase up to 2,424,242 shares of common stock (see Note 6). The pre-funded warrants are exercisable for shares of common stock at a price of $ 0.001 per share. The shares of common stock into which the pre-funded warrants may be exercised are considered outstanding for the purposes of computing earnings per share because the shares may be issued for little or no consideration, are fully vested, and are exercisable after the original issuance date.
A reconciliation of the numerators and the denominators of the basic and diluted net income (loss) per common share computations is as follows (in thousands, except per share amounts):
Three Months Ended June 30,
Six Months Ended June 30,
2020
2019
2020
2019
Numerator:
Net income (loss)
7,270
( 18,503
)
( 19,385
)
( 45,555
)
Denominator:
Shares used in per share calculation - basic
35,307,669
25,740,500
35,229,570
25,690,617
Dilutive effect of securities
1,983,805
-
-
-
Shares used in per share calculation - diluted
37,291,474
25,740,500
35,229,570
25,690,617
Net income (loss) per share:
Basic
0.21
( 0.72
)
( 0.55
)
( 1.77
)
Diluted
0.19
( 0.72
)
( 0.55
)
( 1.77
)
Securities excluded from the computation of diluted income (loss) per share because including them would have been antidilutive are as follows:
Three Months Ended June 30,
Six Months Ended June 30,
2020
2019
2020
2019
Warrants to purchase common stock
15,296
15,296
15,296
15,296
Options to purchase common stock
3,521,778
5,203,935
6,652,076
5,203,935
Common stock subject to purchase under our ESPP
8,991
5,976
8,991
5,976
Unvested RSUs
41,762
489,857
978,879
489,857
Total
3,587,827
5,715,064
7,655,242
5,715,064
As of June 30, 2020, 145,000 performance-based RSUs granted by the Company were excluded from the table above because they are subject to contingencies that were not achieved as of this date.
8
ASSEMBLY BIOSCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Adoption of Recent Accounting Pronouncements
In January 2017, the Financial Accounting Standards Board (FASB) issued ASU 2017-04, Intangibles-Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment (ASU 2017-04), which simplifies how an entity is required to test goodwill for impairment by eliminating Step 2 from the goodwill impairment test. Step 2 measures a goodwill impairment loss by comparing the implied fair value of a reporting unit's goodwill with the carrying amount of that goodwill. Under the amendments in ASU 2017-04, an entity should recognize an impairment charge for the amount by which the carrying amount of a reporting unit exceeds its fair value; however, the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. The updated guidance requires a prospective adoption. In November 2019, the FASB issued ASU 2019-10, Financial Instruments – Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842): Effective Dates (ASU 2019-10), which deferred the effective date of this standard for all entities except SEC filers that are not smaller reporting companies to fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. Early adoption is permitted for goodwill impairment tests performed on testing dates after January 1, 2017. The Company early adopted ASU 2017-04 effective January 1, 2020. The adoption of this standard had no material impact on the Company’s condensed consolidated financial statements.
On January 1, 2020, the Company adopted ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement, which makes a number of changes meant to add, modify or remove certain disclosure requirements associated with the movement amongst or hierarchy associated with Level 1, Level 2 and Level 3 fair value measurements. The adoption of this standard had no material impact on the Company’s condensed consolidated financial statements and related disclosures.
On January 1, 2020, the Company adopted ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 , which clarifies that certain transactions between collaborative arrangement participants should be accounted for as revenue under Topic 606 when the collaborative arrangement participant is a customer in the context of a unit of account. In those situations, all the guidance in Topic 606 should be applied, including recognition, measurement, presentation, and disclosure requirements. The standard adds unit-of-account guidance in Topic 808 to align with the guidance in Topic 606 (that is, a distinct good or service) when an entity is assessing whether the collaborative arrangement or a part of the arrangement is within the scope of Topic 606 and requires that in a transaction with a collaborative arrangement participant that is not directly related to sales to third parties, presenting the transaction together with revenue recognized under Topic 606 is precluded if the collaborative arrangement participant is not a customer. Amendments in the standard should be applied retrospectively to the date of initial application of Topic 606, but entities may elect to apply the amendments in Topic 808 retrospectively either to all contracts or only to contracts that are not completed at the date of initial application of Topic 606, and should disclose the election. An entity may also elect to apply the practical expedient for contract modifications that is permitted for entities using the modified retrospective transition method in Topic 606. The adoption of this standard had no impact on the Company’s condensed consolidated financial statements and related disclosures.
In December 2019, the FASB issued ASU No. 2019-12, Simplifying the Accounting for Income Taxes (ASU 2019-12), which eliminates certain exceptions to the guidance in ASC 740 related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. The new guidance also simplifies aspects of the accounting for franchise taxes and enacted changes in tax laws or rates and clarifies the accounting for transactions that result in a step-up in the tax basis of goodwill. The standard is effective for fiscal years beginning after December 15, 2020 and interim periods within those fiscal years. Early adoption is permitted in an interim or annual period. Entities that elect to early adopt the amendments in an interim period should reflect any adjustments as of the beginning of the annual period that includes that interim period. Additionally, entities that elect early adoption must adopt all the amendments in the same period. Entities will apply the guidance prospectively, except for certain amendments. The Company early adopted ASU 2019-12 effective January 1, 2020. The adoption of this standard did not have a material impact on the Company’s condensed consolidated financial statements and related disclosures.
9
ASSEMBLY BIOSCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Recent Accounting Pronouncements
In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments (ASU 2016-13), which requires that expected credit losses relating to financial assets measured on an amortized cost basis and available-for-sale debt securities be recorded through an allowance for credit losses. ASU 2016-13 limits the amount of credit losses to be recognized for available-for-sale debt securities to the amount by which carrying value exceeds fair value and also requires the reversal of previously recognized credit losses if fair value increases. In April, May and November 2019, the FASB issued additional amendments to the new guidance related to transition and clarification. In November 2019, the FASB issued ASU 2019-10, which deferred the effective date of this standard for all entities except SEC filers that are not smaller reporting companies to fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. Early adoption is permitted. The Company is evaluating this new accounting standard but currently does not expect the adoption of this standard to have a material impact on its condensed consolidated financial statements and related disclosures.
Note 3 – Investments in Marketable Securities
The carrying amounts of cash equivalents and marketable securities approximate their fair value based upon quoted market prices. Certain of the Company’s financial instruments are not measured at fair value on a recurring basis, but are recorded at amounts that approximate their fair value due to their liquid or short-term nature, such as cash, accounts receivable, accounts payable, accrued expenses, lease liability-short term and deferred revenue-short term.
The Company uses the following three-level hierarchy that maximizes the use of observable inputs and minimizes the use of unobservable inputs to value its financial instruments:
Level 1: Observable inputs such as unadjusted quoted prices in active markets for identical instruments.
Level 2: Quoted prices for similar instruments that are directly or indirectly observable in the marketplace.
Level 3: Significant unobservable inputs that are supported by little or no market activity and that are financial instruments whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation.
Investments in marketable securities consisted of the following (in thousands):
June 30, 2020
Amortized
Cost
Gross
Unrealized
Gain
Gross
Unrealized
Loss
Fair Value
Cash equivalents
Money market funds
$
94,524
$
—
$
—
$
94,524
Total cash equivalents
94,524
—
—
94,524
Short-term investments
U.S. and foreign corporate debt securities
32,958
161
—
33,119
Asset-backed securities
22,183
72
—
22,255
U.S. treasury securities
36,080
176
—
36,256
U.S. and foreign commercial paper
38,375
—
—
38,375
Total short-term investments
129,596
409
—
130,005
Total cash equivalents and investments
$
224,120
$
409
$
—
$
224,529
10
ASSEMBLY BIOSCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
December 31, 2019
Amortized
Cost
Gross
Unrealized
Gain (1)
Gross
Unrealized
Loss (1)
Fair Value
Cash equivalents
Money market funds
$
33,095
$
—
$
—
$
33,095
U.S. and foreign corporate debt securities
5,000
—
( 1
)
4,999
U.S. and foreign commercial paper
4,484
—
—
4,484
Total cash equivalents
42,579
—
( 1
)
42,578
Short-term investments
U.S. and foreign corporate debt securities
72,452
38
( 4
)
72,486
Asset-backed securities
34,008
17
—
34,025
U.S. treasury securities
44,692
24
( 2
)
44,714
U.S. and foreign commercial paper
76,086
—
—
76,086
Total short-term investments
227,238
79
( 6
)
227,311
Total cash equivalents and investments
$
269,817
$
79
$
( 7
)
$
269,889
(1)
Gross unrealized gain (loss) is pre-tax.
The contractual term to maturity of short-term marketable securities held by the Company as of June 30, 2020 is less than one year . There were no long-term marketable securities held by the Company as of June 30, 2020.
Realized gains and losses for the three and six months ended June 30, 2020 and 2019 were not significant. None of the Company’s investments have been in a continuous unrealized loss position for more than 12 months as of June 30, 2020.
The following tables present the fair value of the Company’s financial assets measured at fair value on a recurring basis (in thousands):
June 30, 2020
Level 1
Level 2
Level 3
Fair Value
Cash equivalents
Money market fund
$
94,524
$
—
$
—
$
94,524
Total cash equivalents
94,524
—
—
94,524
Short-term investments
U.S. and foreign corporate debt securities
—
33,119
—
33,119
Asset-backed securities
—
22,255
—
22,255
U.S. treasury securities
—
36,256
—
36,256
U.S. and foreign commercial paper
—
38,375
—
38,375
Total short-term investments
—
130,005
—
130,005
Total assets measured at fair value
$
94,524
$
130,005
$
—
$
224,529
11
ASSEMBLY BIOSCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
December 31, 2019
Level 1
Level 2
Level 3
Fair Value
Cash equivalents
Money market fund
33,095
—
—
33,095
U.S. and foreign corporate debt securities
—
4,999
—
4,999
U.S. and foreign commercial paper
—
4,484
—
4,484
Total cash equivalents
33,095
9,483
—
42,578
Short-term investments
U.S. and foreign corporate debt securities
—
72,486
—
72,486
Asset-backed securities
—
34,025
—
34,025
U.S. treasury securities
—
44,714
—
44,714
U.S. and foreign commercial paper
—
76,086
—
76,086
Total short-term investments
—
227,311
—
227,311
Total assets measured at fair value
$
33,095
$
236,794
$
—
$
269,889
The Company estimates the fair value of its U.S. and foreign corporate debt securities, asset-backed securities, U.S. treasury securities and U.S. and foreign commercial paper by taking into consideration valuations obtained from third-party pricing services. The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar securities, issuer credit spreads, benchmark securities, prepayment/default projections based on historical data, and other observable inputs.
There were no transfers between Level 1, Level 2 or Level 3 during the periods presented.
Note 4 - Property and Equipment, Net
Property and equipment consist of the following (in thousands):
Useful life
June 30,
December 31,
(Years)
2020
2019
Lab equipment
3 to 5
$
290
$
247
Office equipment
7
699
699
Leasehold improvement
1 to 5
2,084
2,084
Total property and equipment
3,073
3,030
Less: Accumulated depreciation and amortization
( 1,437
)
( 1,200
)
Construction in progress
N/A
427
—
Property and equipment, net
$
2,063
$
1,830
Depreciation expense was $ 0.1 million and $ 0.2 million for the three and six months ended June 30, 2020, respectively and $ 0.1 million and $ 0.3 million for the three and six months ended June 30, 2019, respectively and was recorded in both research and development expense and general and administrative expense in the unaudited condensed consolidated statements of operations and comprehensive loss. Primarily all of property and equipment of the Company is located in the U.S.
12
ASSEMBLY BIOSCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Note 5 – Accrued Expenses
Accrued expenses consist of the following (in thousands):
June 30,
December 31,
2020
2019
Accrued expenses:
Accrued compensation
$
4,186
$
5,312
Accrued restructuring charges
1,019
2,094
Accrued professional fees and other
814
880
Total accrued expenses
$
6,019
$
8,286
Accrued restructuring charges relate to the Company’s decision to relocate its headquarters to South San Francisco, California as approved by the Board of Directors in November 2019 and effective January 1, 2020. The Company accrued restructuring charges of $ 2.1 million in 2019 related to one-time severance payments and other employee-related costs associated with the relocation plan. This represents the total amount expected to be incurred in connection with the relocation and is expected to be fully paid in 2020.
Note 6 – Stockholders’ Equity
The Company is authorized to issue 5,000,000 shares of preferred stock as of June 30, 2020 and December 31, 2019, respectively. As of June 30, 2020 and December 31, 2019, no shares of preferred stock were issued and outstanding. The Company is authorized to issue 100,000,000 shares of common stock as of June 30, 2020 and December 31, 2019, respectively.
Sale of Common Stock and Pre-Funded Warrants
In December 2017, the Company filed a registration statement on Form S-3 with the SEC using a “shelf” registration statement, file No. 333-222366, which became effective January 10, 2018 (the Registration Statement). Under this shelf registration process, the Company may from time to time sell any combination of the securities described in the Registration Statement in one or more offerings up to an aggregate offering price of $ 250.0 million. In connection with the filing of this Registration Statement, the Company entered into a sales agreement under which the Company may offer and sell shares of its common stock having an aggregate offering price of up to $ 75.0 million through “at the market offerings” (ATM). As of June 30, 2020, no shares have been sold under the ATM program and $ 21.4 million remains available for sale under this Registration Statement.
In December 2019, the Company sold to various investors an aggregate of 6,287,878 shares of common stock at a public offering price of $ 16.50 per share, which included the exercise in full by the underwriters of their option to purchase 1,136,363 additional shares of common stock, and pre-funded warrants to purchase 2,424,242 shares of common stock at a public offering price of $ 16.499 per warrant. The Company received aggregate net proceeds of $ 134.7 million from the offering and the option exercise, after deducting underwriting discounts and commissions and offering expenses payable by the Company. The pre-funded warrants became immediately exercisable upon issuance at an exercise price of $ 0.001 per share, but under their terms, the outstanding pre-funded warrants to purchase shares of the Company’s common stock generally may not be exercised if the holder’s ownership of the Company’s common stock would exceed 19.99 % following such exercise. The exercise price and number of shares of common stock issuable upon the exercise of the pre-funded warrants (Warrant Shares) are subject to adjustment in the event of any stock dividends and splits, reverse stock split, recapitalization, reorganization or similar transaction, as described in the pre-funded warrant agreements. Under certain circumstances, the pre-funded warrants may be exercisable on a “cashless” basis. Both the pre-funded warrants and the Warrant Shares are registered securities.
13
ASSEMBLY BIOSCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
The pre-funded warrants were classified as a component of permanent stockholders’ equity within additional paid-in-capital and were recorded at the issuance date using a relative fair value allocation method. The pre-funded warrants are equity classified because they are freestanding financial instruments that are legally detachable and separately exercisable from the equity instruments, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, permit the holders to receive a fixed number of common shares upon exercise, are indexed to the Company’s common stock and meet the equity classification criteria. In addition, such pre-funded warrants do not provide any guarantee of value or return. The Company valued the pre-funded warrants at issuance, concluding their sales price approximated their fair value, and allocated net proceeds from the sale proportionately to the common stock and pre-funded warrants of which $ 37.5 million was allocated to the pre-funded warrants and recorded as a component of additional paid-in-capital.
Common Stock Warrants
As of June 30, 2020 and December 31, 2019 the following warrants to purchase shares of the Company’s common stock were issued and outstanding:
Issue date
Expiration
date
Exercise Price
per Share
Number of
warrants
outstanding
September 10, 2010
September 10, 2020
$
30.000
15,296
December 16, 2019
None
$
0.001
2,424,242
2,439,538
There were no warrants exercised during the three and six months ended June 30, 2020 or 2019.
Note 7 – Stock Plans and Stock-Based Compensation
Equity Incentive Plans
In May 2018, the Company’s stockholders approved (1) the Assembly Biosciences, Inc. 2018 Stock Incentive Plan (the 2018 Plan) pursuant to which the Company reserved 1,900,000 shares of its common stock for issuance in connection with equity incentive awards and (2) the Assembly Biosciences Inc. Employee Stock Purchase Plan (the 2018 ESPP) pursuant to which the Company reserved 400,000 shares of its common stock for issuance in connection with purchases by employees pursuant to this plan.
In May 2019, the Company’s stockholders approved an amendment to the 2018 Plan that increased the aggregate number of shares of common stock reserved under the 2018 Plan to 3,000,000 .
In June 2020, the Company’s stockholders approved an amendment to the 2018 Plan that increased the aggregate number of shares of common stock reserved under the 2018 Plan to 4,600,000 .
As of June 30, 2020, the Company had awards outstanding under the following shareholder-approved plans: 2010 Equity Incentive Plan (the 2010 Plan), which has been frozen; the Amended and Restated 2014 Stock Incentive Plan (the 2014 Plan); and the 2018 Plan. Shares of common stock underlying awards that are forfeited under the 2010 Plan on or after June 2, 2016 will become available for issuance under the 2014 Plan. As of June 30, 2020, the Company also had awards outstanding under the Assembly Biosciences, Inc. 2017 Inducement Award Plan (the 2017 Plan), the Assembly Biosciences, Inc. 2019 Inducement Award Plan (the 2019 Plan) and the Assembly Biosciences, Inc. 2020 Inducement Award Plan (the 2020 Plan).
The Company issues new shares of common stock to settle options exercised and vested RSUs. The Company also issues new shares of common stock in connection with purchases of shares of common stock by eligible employees under the Company’s 2018 ESPP.
14
ASSEMBLY BIOSCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Stock Plan Activity
Stock Options
A summary of the Company’s option activity and related information for the six months ended June 30, 2020 is as follows:
Number
of Shares
Weighted
Average
Exercise
Price
Per Share
Weighted
Average
Remaining
Contractual
Term
(Years)
Total
Intrinsic
Value (in
thousands)
Outstanding as of December 31, 2019
5,613,353
$
15.90
Granted
1,275,180
15.92
Exercised
( 91,713
)
7.38
Forfeited
( 144,744
)
25.57
Outstanding as of June 30, 2020
6,652,076
$
15.81
7.3
$
63,186
Options vested and exercisable as of June 30, 2020
3,440,092
$
14.22
5.6
$
39,923
The weighted-average grant-date fair value of options granted was $ 10.52 and $ 12.68 during the six months ended June 30, 2020 and 2019, respectively. The total intrinsic value of options exercised during the six months ended June 30, 2020 and 2019 was $ 1.0 million and $ 0.7 million, respectively.
RSUs
A summary of the Company’s RSUs and related information for the six months ended June 30, 2020 is as follows:
Number
of RSUs
Weighted
Average Fair
Value Per RSU
at Grant Price
Nonvested as of December 31, 2019
758,718
$
25.47
Granted
531,164
16.31
Vested
( 99,224
)
33.59
Forfeited
( 54,279
)
25.90
Nonvested as of June 30, 2020
1,136,379
(1)
$
20.45
(1)
Includes 157,500 RSUs that have vested but are subject to deferred settlement, which have a weighted average remaining contractual term of 1.7 years.
The total fair value of RSUs vested and settled during the six months ended June 30, 2020 and 2019 was $ 3.1 million and $ 2.9 million, respectively. The total intrinsic value of RSUs vested and settled during the six months ended June 30, 2020 and 2019 was $ 1.6 million and $ 1.3 million, respectively.
As of June 30, 2020, RSUs outstanding include 45,000 RSUs granted in December 2017 and 100,000 RSUs granted in September 2019 to executives of the Company with performance-based conditions vesting conditions. As of June 30, 2020, the performance condition for the 45,000 RSUs granted in December 2017 was deemed probable of being met and was subsequently achieved in July 2020. The Company recognized $ 0.7 million as a cumulative catch-up adjustment of stock-based compensation expense for this award for the three and six months ended June 30, 2020. The remaining 100,000 awards with an aggregate fair value of $ 1.2 million vest upon performance conditions not yet deemed probable and accordingly no stock-based compensation expense has been recognized as of June 30, 2020.
15
ASSEMBLY BIOSCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
ESPP
Employees purchased 42,266 and 36,804 shares of common stock under the 2018 ESPP during the six months ended June 30, 2020 and 2019, respectively.
Valuation Assumptions
The fair value of the stock options granted or modified during the periods indicated was estimated using the Black-Scholes option pricing model, based on the following assumptions:
Three Months Ended June 30,
Six Months Ended June 30,
2020
2019
2020
2019
Exercise price
$14.57 - $20.52
$15.22 - $57.33
$14.45 - $20.52
$15.22 - $57.33
Expected volatility
69.13% - 82.24%
66.2% - 83.0%
66.38% - 82.24%
66.2% - 83.2%
Risk-free rate
0.36% - 0.60%
2.17% - 2.47%
0.36% - 1.44%
2.17% - 2.65%
Expected term (years)
5.5 - 7.5
5.0 - 9.0
5.5 - 7.5
5.0 - 9.0
Expected dividend yield
0 %
0 %
0 %
0 %
The fair value of RSUs granted is determined based on the price of the Company’s common stock on the date of grant.
The fair value of ESPP purchase rights were not material for any period presented.
Stock-Based Compensation Expense
The following table summarizes the components of total stock-based compensation expense included in the condensed consolidated statements of operations and comprehensive loss (in thousands):
Three Months Ended June 30,
Six Months Ended June 30,
2020
2019
2020
2019
Research and development
$
3,607
$
3,116
$
5,551
$
5,845
General and administrative
3,527
( 1,048
)
(1)
6,507
2,800
Total stock-based compensation expense
$
7,134
$
2,068
$
12,058
$
8,645
(1)
Includes the reversal of previously recognized stock-based compensation expense of $ 3.6 million related to forfeited awards resulting from the departure of one of the Company’s former officers during the period.
As of June 30, 2020, there was $ 32.2 million of total unrecognized stock-based compensation related to outstanding equity awards which is expected to be recognized over a weighted average remaining amortization period of 1.8 years.
16
ASSEMBLY BIOSCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Note 8 - Collaboration Agreement
Termination of Allergan Collaboration Agreement
In January 2017, the Company entered into the Allergan Collaboration Agreement with Allergan to develop and commercialize select microbiome gastrointestinal disease therapies. Pursuant to the Allergan Collaboration Agreement, the Company granted to Allergan an exclusive worldwide license to certain of its intellectual property, including its intellectual property arising under the Allergan Collaboration Agreement, to develop and commercialize licensed compounds for UC, Crohn’s disease, and two compounds for IBS. Allergan and the Company also agreed to collaborate on research and development activities with respect to the licensed compounds in accordance with a mutually agreed upon research and development plan. Per the terms of the Allergan Collaboration Agreement, Allergan could select backups and additional target indications to add to the licenses granted for additional consideration and also had the ability to enter into a contract manufacturing agreement with the Company for compound supply at cost plus an agreed upon margin. In addition, the Company participated in a Joint Development Committee (JDC) and Joint Patent Committee (JPC). Allergan had the right to terminate the Allergan Collaboration Agreement at any time upon advance written notice.
In June 2020, following its acquisition of Allergan, AbbVie, on behalf of Allergan, gave written notice of termination of the Allergan Collaboration Agreement, effective 120 days following the delivery of notice, on October 10, 2020. Upon termination, the licenses granted by the Company and its know-how will revert to the Company. Under the terms of the Allergan Collaboration Agreement, AbbVie is obligated to continue to reimburse the Company for certain research and development costs through October 10, 2020. Upon effectiveness of the termination, such reimbursements will cease. Due to the delivery of the termination notice, the Company determined that there were no further enforceable rights and obligations under the Allergan Collaboration Agreement beyond June 2020 and the remaining $ 36.0 million of deferred revenue was recognized in the period.
History of the Allergan Collaboration Agreement
Allergan paid the Company an upfront non-refundable payment of $ 50.0 million, which was received in 2017. Additionally, the Company is eligible to receive variable consideration in the form of research and development cost reimbursements, up to $ 631.0 million related to seven development milestones and up to $ 2.14 billion related to 12 commercial development and sales milestones in connection with the successful development and commercialization of licensed compounds. In addition, the Company was eligible to receive tiered royalties at rates ranging from the mid-single digits to the mid-teens based on net sales.
Allergan and the Company agreed to share research and development costs up to an aggregate of $ 75.0 million through proof-of-concept (POC) studies on a ⅔, ⅓ basis, respectively, and Allergan agreed to assume all post-POC development costs. In the event any pre-POC development costs exceed $ 75.0 million in the aggregate, the Company could have elected either (a) to fund ⅓ of such costs in excess of $ 75.0 million or (b) to allow Allergan to deduct from future development milestone payments ⅓ of the development costs funded by Allergan in excess of $ 75.0 million plus a premium of 25 %. The Company had an option to co-promote the licensed programs in the U.S. and China, subject to certain conditions set forth in the Allergan Collaboration Agreement.
The Company concluded that Allergan was a customer, and the contract was not subject to accounting literature on collaborative arrangements. This is because the Company granted to Allergan licenses to its intellectual property and research and development services, all of which are outputs of the Company’s ongoing activities, in exchange for consideration. The Company identified the following material promises under the Allergan Collaboration Agreement: (1) grant of licenses to intellectual property for the four initial indications, inclusive of the related technology know-how (Licenses) and (2) the obligation to perform research development services through POC (Development Services). The Company’s participation on the JDC and JPC were considered to be immaterial in the context of the contract. The Company’s co-promotion option was not considered to be a performance obligation. Allergan’s selection of backups or additional target indications to add to the licenses granted for additional consideration and ability to enter into a contract manufacturing agreement with the Company for compound supply at cost plus an agreed upon margin were not considered to be performance obligations as the Company concluded the options were not offered at a discount that exceeds discounts available to other customers, and therefore were not material rights. The grant of additional licensing rights upon option exercises and contract manufacturing agreements were to be accounted for as separate contracts when or if they occurred.
17
ASSEMBLY BIOSCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
The Company concluded the Licenses each were considered to be functional as they ha d significant standalone functionality and were capable of being distinct. However, the Company determined that each of the Licenses individually were not distinct from the Development Services within the context of the agreement. This is because Allergan wa s dependent on the Company to execute the Development Services, which it wa s uniquely able to perform, in order for Allergan to benefit from the Licenses. As such, the Company determined that it ha d four performance obligations under the Allergan Collaboration Agreement associated with the grant of the four compound Licenses combined with the performance of the Development Services for each of the four compound indications. The Company determined that the four performance obligations would have been performed over the duration of the contract, which began in February 2017 and ended upon receipt of the termination notice . The Company used a cost-based input method to measure proportional performance and to calculate the corresponding amount of revenue to recognize. The Company believe d this was the best measure of progress because other measures do not reflect how the Company transfers its performance obligation to Allergan. In applying the cost-based input method of revenue recognition, the Company measure d costs incurred relative to budgeted costs to fulfill the four performance obligations. These costs consist ed primarily of third-party contract costs and internal labor costs. Revenue was recognized based on actual costs incurred as a percentage of total budgeted costs as the Company complete d its performance obligations.
To allocate transaction price among the four performance obligations, the Company estimated their standalone selling price (SSP) using an income-based valuation approach for the estimated value a licensor of the compounds would receive considering the stage of the compounds’ development. A change in the assumptions used to determine its best estimate of selling price for the four performance obligations would not have had a significant effect on the allocation of consideration received to the four performance obligations.
The transaction price at the inception of the agreement and upon adoption of the revenue from contracts with customers guidance was limited to $ 50.0 million upfront payment. Of this amount, the Company allocated $ 12.5 million to each of the four performance obligations. Research and development cost reimbursement payments are included in the transaction price in the reporting period that the Company concludes that it is probable that recording revenue in the period will not result in a significant reversal in amounts recognized in future periods. The variable consideration related to the remaining development and commercialization milestone payments has not been included in the transaction price as these were fully constrained at June 30, 2020. As part of the Company’s evaluation of the development and commercialization milestones constraint, the Company determined that the achievement of such milestones is contingent upon success in future clinical trials and regulatory approvals which are not within its control and uncertain at this stage. Any variable consideration related to sales-based milestones (including royalties) would have been recognized when the related sales occur as they were determined to relate predominantly to the license granted to Allergan. The Company re-evaluated the transaction price in each reporting period and as uncertain events were resolved or other changes in circumstances occur.
The Company did not incur any significant incremental costs of obtaining the Allergan contract.
For the six months ended June 30, 2020 and 2019, the Company recognized $ 43.5 million and $ 7.0 million, respectively, in revenue associated with the Allergan Collaboration Agreement. Short-term and long-term deferred revenue contract liabilities related to the Allergan Collaboration Agreement were $ 6.4 million and $ 30.6 million at December 31, 2019. There were no deferred revenue contract liabilities as of June 30, 2020 due to the Company recognizing a cumulative catch-up adjustment of the remaining deferred revenue balance during the three months ended June 30, 2020 for the determined completion of the Company’s performance obligations under the Allergan Collaboration Agreement upon receipt of the notice of termination from AbbVie.
On the unaudited condensed consolidated balance sheets, contract asset balances of $ 3.3 million and $ 3.4 million were recorded as accounts receivable from collaboration as of June 30, 2020 and December 31, 2019, respectively.
18
ASSEMBLY BIOSCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
The following table presents changes in the Company’s contract liabilities (in thousands):
Balance at
Beginning
of Period
Additions
Deductions
Balance at
End of
Period
Six Months Ended June 30, 2020
Contract liabilities:
Deferred revenue
$
37,048
$
—
$
( 37,048
)
$
—
Balance at
Beginning
of Period
Additions
Deductions
Balance at
End of
Period
Six Months Ended June 30, 2019
Contract liabilities:
Deferred revenue
$
40,660
$
—
$
( 996
)
$
39,664
Three Months Ended June 30,
Six Months Ended June 30,
2020
2019
2020
2019
Collaboration revenue recognized in the period from
Amounts included in deferred revenue at the beginning of the period
$
36,041
$
137
$
37,048
$
996
Performance obligations satisfied in previous period
—
—
—
—
Note 9 - Milestones and Research Agreements
HBV Research Agreement with Indiana University
Since September 2013, the Company has been party to an exclusive License Agreement dated September 3, 2013 with Indiana University Research and Technology Corporation (IURTC) from whom it has licensed aspects of the Company’s HBV program held by IURTC. The license agreement requires the Company to make milestone payments based upon the successful accomplishment of clinical and regulatory milestones. The aggregate amount of all performance milestone payments under the IURTC license agreement, should all milestones through development be met, is $ 0.8 million, with a portion related to the first performance milestone having been paid. The Company is obligated to pay IURTC royalty payments based on net sales of the licensed technology. The Company is also required to pay diligence maintenance fees each year to the extent that the royalty, sublicensing, and milestone payments to IURTC are less than such fees for that year. Amounts paid in the six months ended June 30, 2020 and 2019 were insignificant.
Microbiome Targeted Colonic Delivery Platform
In November 2013, the Company entered into a License and Collaboration Agreement with Therabiome, LLC (Therabiome), for all intellectual property and know-how owned or controlled by Therabiome relating to the oral delivery of pharmaceutical drugs to specific sites in the intestine, using a pH sensitive controlled release capsule-in-capsule technology. The Company will be solely responsible for all research and development activities with respect to any product it develops under the license.
The Company must pay Therabiome clinical and regulatory milestones for each product or therapy advanced from the platform for U.S. regulatory milestones. In addition, the Company must pay Therabiome lesser amounts for foreign regulatory milestones, which vary by country and region. The Company is also required to pay Therabiome royalties on annual net sales of a product in the low to mid-single digit percentages plus, once annual net sales exceed certain thresholds, a one-time cash payment upon reaching such thresholds.
Therabiome must pay the Company royalties on annual net sales of any product Therabiome is permitted to develop using the intellectual property in the low double to mid-double-digit percentages, depending on the level of development or involvement the Company had in the product.
19
ASSEMBLY BIOSCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
No amounts were accrued for this agreement as of and for the six months ended June 30, 2020. Two regulatory milestones were determined to have occurred under this agreement and $ 0.3 million was accrued and included in accrued expenses during the six months ended June 30, 2019.
Note 10 - Leases
Operating Leases
The Company leases office space for corporate, administrative and laboratory functions in South San Francisco, California under a sub-sublease that expires in December 2023. The Company also leases office space in Carmel, Indiana under a lease agreement that expires in August 2023, which the Company has subleased. The Company also leases office and laboratory space in Groton, Connecticut under a lease that expires in March 2021. The Company’s China subsidiary leases office space in Shanghai that expires in May 2021 and rents lab space in Shanghai under a lease agreement that expires in December 2020. Additionally, the Company’s China subsidiary leases office space in Beijing under a lease agreement that expires in December 2020. Certain lease contracts contain renewal clauses that the Company assesses on a case by case basis. The Company also leases certain laboratory equipment accounted for as operating leases. Certain equipment leases continue to expire in 2020, with the final lease expiring in 2023.
When the Company cannot determine the implicit rate in its leasing arrangements, the Company uses its incremental borrowing rate as the discount rate when measuring operating lease liabilities. The incremental borrowing rate represents an estimate of the interest rate the Company would incur at lease commencement to borrow an amount equal to the lease payments on a collateralized basis over the term of a lease within a particular currency environment.
At June 30, 2020, the Company had operating lease liabilities of $ 11.1 million and ROU assets of $ 10.8 million, which were included in the condensed consolidated balance sheet.
The following summarizes quantitative information about the Company’s operating leases (in thousands):
Three Months Ended June 30,
Six Months Ended June 30,
2020
2019
2020
2019
Lease cost
Operating lease cost
$
1,158
$
1,117
$
2,308
$
2,208
Short-term lease cost
100
112
200
433
Variable lease cost
408
300
692
599
Total lease cost
$
1,666
$
1,529
$
3,200
$
3,240
Six Months Ended June 30,
2020
2019
Operating cash flows from operating leases
$
2,247
$
2,099
ROU assets exchanged for new operating lease liabilities
$
545
$
14,225
As of June 30, 2020 and December 31, 2019, the weighted-average remaining lease term for operating leases was 3.3 years and 2.7 years, respectively. As of June 30, 2020 and December 31, 2019, the weighted-average discount rate for operating leases was 9.5 % and 9.4 %, respectively.
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ASSEMBLY BIOSCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
As of June 30, 2020, the maturities of the Company’s operating lease liabilities were as follows (in thousands):
Six months ending December 31, 2020
$
2,356
Year Ending December 31, 2021
3,991
Year Ending December 31, 2022
3,627
Year Ending December 31, 2023
3,325
Total
13,299
Less: present value discount
( 2,165
)
Operating lease liabilities
$
11,134
Note 11 – Subsequent Events
On July 17, 2020, the Company entered into a Collaboration Agreement (China Collaboration Agreement) with BeiGene, Ltd. (BeiGene), granting BeiGene an exclusive, royalty-bearing license to develop and commercialize the Company’s novel core inhibitor product candidates ABI-H0731, ABI-H2158 and ABI-H3733 for chronic HBV infection (the Licensed Product Candidates) in the People’s Republic of China, Hong Kong, Taiwan and Macau (the Territory).
Pursuant to the terms of the China Collaboration Agreement, the Company received an upfront cash payment of $ 40.0 million from BeiGene, and the Company is eligible to receive up to approximately $ 500.0 million in cash milestone payments, comprised of up to $ 113.8 million for development and regulatory milestones and up to $ 385.0 million in net sales milestones. In addition, the Company is eligible to receive tiered royalties at percentages ranging from the mid-teens to the low thirties of net sales. BeiGene also agreed to pay all development and regulatory costs for the Licensed Product Candidates in the Territory up to an aggregate of $ 45.0 million. Development and regulatory costs for the Licensed Product Candidates for the Territory in excess of $ 45.0 million will be shared equally by the Company and BeiGene.
The China Collaboration Agreement also contains provisions such as representations and warranties of the parties, terms as to governance of the collaboration, commercialization and regulatory responsibilities of the parties, and manufacturing and supply, including potential adjustments in the event supply costs exceed certain levels. In addition, during the term of the China Collaboration Agreement, neither party will commercialize any competing products in the Territory.
If, after ABI-H2158 and ABI-H3733 reach the end of Phase 2 clinical trials, the Company and BeiGene are unable to mutually agree on the terms of a Phase 3 global study, BeiGene may elect to terminate the China Collaboration Agreement solely as it relates to that compound, as applicable. Such a termination would result in the Company regaining all rights to the applicable compound in the Territory. In addition, BeiGene may terminate the China Collaboration Agreement for convenience at any time upon 90 days’ advance written notice to us. The China Collaboration Agreement also contains customary provisions for termination by either party, including in the event of breach of the China Collaboration Agreement, subject to cure.
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