Item 1. Financial Statements
Item 1. Financial Statements.
REPLIMUNE GROUP, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share and
per share amounts)
(Unaudited)
September 30,
March 31,
2020
2020
Assets
Current assets:
Cash and cash equivalents
$ 43,326
$ 59,500
Short-term investments
201,320
109,055
Research and development incentives receivable
3,081
2,962
Prepaid expenses and other current assets
4,687
2,734
Total current assets
252,414
174,251
Property, plant and equipment, net
7,166
6,860
Research and development incentives receivable - long term
1,462
-
Restricted cash
1,636
1,636
Right-to-use asset - operating leases
5,830
4,425
Right-to-use asset - financing leases
45,736
46,925
Total assets
$ 314,244
$ 234,097
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable
$ 2,374
$ 3,434
Accrued expenses and other current liabilities
7,245
5,156
Operating lease liabilities, current
896
873
Financing lease liabilities, current
2,450
2,411
Total current liabilities
12,965
11,874
Long term debt, net of debt discount
9,827
9,801
Operating lease liabilities, non-current
5,177
3,737
Financing lease liabilities, non-current
24,885
24,967
Total liabilities
52,854
50,379
Commitments and contingencies (Note 12)
Stockholders' equity
Common stock, $0.001 par value; 150,000,000 shares authorized as of September 30, 2020 and March 31, 2020; 40,312,272 and 36,668,743 shares issued and outstanding as of September 30, 2020 and March 31, 2020, respectively
40
37
Additional paid-in capital
411,847
296,961
Accumulated deficit
(149,886 )
(112,298 )
Accumulated other comprehensive loss
(611 )
(982 )
Total stockholders' equity
261,390
183,718
Total liabilities and stockholders' equity
$ 314,244
$ 234,097
The accompanying notes are an integral part
of these condensed consolidated financial statements.
2
REPLIMUNE GROUP, INC.
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
(Amounts in thousands, except share and
per share amounts)
(Unaudited)
Three Months Ended
Six Months Ended
September 30,
September 30,
2020
2019
2020
2019
Operating expenses:
Research and development
$ 14,050
$ 8,168
$ 26,207
$ 15,625
General and administrative
5,613
4,074
11,289
7,524
Total operating expenses
19,663
12,242
37,496
23,149
Loss from operations
(19,663 )
(12,242 )
(37,496 )
(23,149 )
Other income:
Research and development incentives
755
620
1,441
1,241
Investment income
178
567
705
1,254
Interest expense on finance lease liability
(562 )
(195 )
(1,123 )
(195 )
Interest expense on debt obligations
(286 )
-
(570 )
-
Other income
(517 )
111
(545 )
202
Total other income, net
(432 )
1,103
(92 )
2,502
Net loss attributable to common stockholders
$ (20,095 )
$ (11,139 )
$ (37,588 )
$ (20,647 )
Net loss per share attributable to common stockholders, basic and diluted
$ (0.46 )
$ (0.35 )
$ (0.90 )
$ (0.65 )
Weighted average common shares outstanding, basic and diluted
44,015,786
31,675,323
41,950,401
31,668,414
The accompanying notes are an integral part
of these condensed consolidated financial statements.
3
REPLIMUNE GROUP, INC.
CONDENSED CONSOLIDATED STATEMENTS OF
COMPREHENSIVE LOSS
(Amounts in thousands)
(Unaudited)
Three Months Ended
Six Months Ended
September 30,
September 30,
2020
2019
2020
2019
Net loss
$ (20,095 )
$ (11,139 )
$ (37,588 )
$ (20,647 )
Other comprehensive loss:
Foreign currency translation loss
626
(218 )
614
(400 )
Net unrealized gain (loss) on short-term investments, net of tax
(47 )
(40 )
(244 )
25
Comprehensive loss
$ (19,516 )
$ (11,397 )
$ (37,218 )
$ (21,022 )
The accompanying notes are an integral part
of these condensed consolidated financial statements.
4
REPLIMUNE GROUP, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’
EQUITY
(Amounts in thousands, except share amounts)
(Unaudited)
Accumulated
Additional
other
Total
Common stock
paid-in
Accumulated
comprehensive
stockholders’
Shares
Amount
capital
deficit
loss
equity
Balances as of March 31, 2020
36,668,743
$ 37
$ 296,961
$ (112,298 )
$ (982 )
$ 183,718
Issuance of prefunded warrants to purchase common stock, net of $2,100 issuance costs
-
-
32,900
-
-
32,900
Issuance of common stock, net of issuance costs and underwriter fees of $5,117
3,478,261
3
74,879
74,882
Foreign currency translation adjustment
-
-
-
-
(12 )
(12 )
Unrealized loss on short-term investments
-
-
-
-
(196 )
(196 )
Exercise of stock options
133,416
1,547
-
-
1,547
Stock-based compensation expense
-
-
2,468
-
-
2,468
Net loss
-
-
-
(17,493 )
-
(17,493 )
Balances as of June 30, 2020
40,280,420
40
408,755
(129,791 )
(1,190 )
277,814
Foreign currency translation adjustment
-
-
-
-
626
626
Unrealized loss on short-term investments
-
-
-
-
(47 )
(47 )
Exercise of stock options
31,852
-
291
-
-
291
Stock-based compensation expense
-
-
2,801
-
-
2,801
Net loss
-
-
-
(20,095 )
-
(20,095 )
Balances as of September 30, 2020
40,312,272
$ 40
$ 411,847
$ (149,886 )
$ (611 )
$ 261,390
Balances as of March 31, 2019
31,656,950
$ 32
$ 198,645
$ (59,766 )
$ (1,055 )
$ 137,856
Foreign currency translation adjustment
-
-
-
-
(182 )
(182 )
Unrealized gain on short-term investments
-
-
-
-
65
65
Exercise of stock options
6,751
-
18
-
-
18
Stock-based compensation expense
-
-
1,810
-
-
1,810
Impact of adoption of ASC 842
-
-
-
93
-
93
Net loss
-
-
-
(9,508 )
-
(9,508 )
Balances as of June 30, 2019
31,663,701
32
200,473
(69,181 )
(1,172 )
130,152
Foreign currency translation adjustment
-
-
-
-
(218 )
(218 )
Unrealized loss on short-term investments
-
-
-
-
(40 )
(40 )
Exercise of stock options
55,645
-
105
-
-
105
Stock-based compensation expense
-
-
1,781
-
-
1,781
Net loss
-
-
-
(11,139 )
-
(11,139 )
Balances as of September 30, 2019
31,719,346
$ 32
$ 202,359
$ (80,320 )
$ (1,430 )
$ 120,641
The accompanying notes are an integral part
of these condensed consolidated financial statements.
5
REPLIMUNE GROUP, INC.
CONDENSED CONSOLIDATED STATEMENTS OF
CASH FLOWS
(Amounts in thousands)
(Unaudited)
Six Months Ended
September 30,
2020
2019
Cash flows from operating activities:
Net loss
$ (37,588 )
$ (20,647 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense
5,269
3,591
Depreciation and amortization
816
84
Noncash interest expense
126
14
Net amortization of premiums and discounts on short-term investments
409
(730 )
Changes in operating assets and liabilities:
Research and development incentives receivable
(1,438 )
(1,241 )
Prepaid expenses and other current assets
(1,932 )
(2,128 )
Operating lease, right-of-use-asset
238
250
Finance lease, right-of-use-asset
1,188
60
Long term prepaid rent
-
(12,433 )
Accounts payable
(1,198 )
(900 )
Accrued expenses and other current liabilities
2,023
669
Operating lease liabilities
(182 )
(144 )
Net cash used in operating activities
(32,269 )
(33,555 )
Cash flows from investing activities:
Purchases of property, plant and equipment
(1,007 )
(1,146 )
Purchase of short-term investments
(196,535 )
(30,628 )
Proceeds from sales and maturities of short-term investments
103,618
83,909
Net cash provided by (used in) investing activities
(93,924 )
52,135
Cash flows from financing activities:
Proceeds from long-term debt, net of debt issuance costs
(100 )
9,645
Proceeds from issuance of common stock in follow-on public offering, net of issuance costs
74,883
-
Proceeds from issuance of prefunded warrants to purchase common stock, net of issuance costs
32,900
-
Principal payment of finance lease obligation
(42 )
-
Exercise of stock options
1,838
123
Net cash provided by financing activities
109,479
9,768
Effect of exchange rate changes on cash, cash equivalents and restricted cash
540
(304 )
Net increase in cash, cash equivalents and restricted cash
(16,174 )
28,044
Cash, cash equivalents and restricted cash at beginning of period
61,136
26,890
Cash, cash equivalents and restricted cash at end of period
$ 44,962
$ 54,934
Supplemental disclosure of cash flow information:
Cash paid during the period for interest
$ 445
$ -
Supplemental disclosure of non-cash investing and financing activities:
Net unrealized gain (loss) on short-term investments
$ (244 )
$ 25
Issuance costs included in accounts payable
$ -
$ -
Purchases of property and equipment included in accounts payable
$ 79
$ 1,825
Lease assets obtained in exchange for new financing lease liabilities
$ 7,165
Lease assets obtained in exchange for new operating lease liabilities
$ 1,580
$ 5,152
The accompanying notes are an integral part
of these condensed consolidated financial statements.
6
REPLIMUNE GROUP, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
(Amounts in thousands, except share and
per share amounts)
(Unaudited)
1. Nature of the business
Replimune Group, Inc. (the “Company”)
is a clinical-stage biotechnology company focused on the development of oncolytic immunotherapies to treat cancer. Replimune Group, Inc.,
whose predecessor was founded in 2015, is the parent company of its wholly owned, direct and indirect subsidiaries: Replimune Limited
(“Replimune UK”); Replimune, Inc. (“Replimune US”); Replimune Securities Corporation; and Replimune
(Ireland) Limited.
The Company is subject to risks and uncertainties
common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new
technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations
and the ability to secure additional capital to fund operations. Product candidates currently under development will require significant
additional research and development efforts, including preclinical and clinical testing and regulatory approval, prior to commercialization.
These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance
and reporting capabilities. Even if the Company’s product development efforts are successful, it is uncertain when, if ever,
the Company will realize significant revenue from product sales.
Basis of presentation
The accompanying consolidated financial
statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities
and commitments in the ordinary course of business. The Company has incurred recurring losses since its inception, including net
losses of $20,095 and $11,139 for the three months ended September 30, 2020 and 2019, respectively and net losses of $37,588 and
$20,647 for the six months ended September 30, 2020 and 2019, respectively. In addition, as of September 30, 2020, the Company
had an accumulated deficit of $149,886. The Company expects to continue to generate operating losses for the foreseeable future.
As of the issuance date of these consolidated financial statements, the Company expects that its cash and cash equivalents and
short-term investments will be sufficient to fund its operating expenses and capital expenditure requirements through at least
12 months from the issuance of the consolidated financial statements.
Impact of the COVID-19 coronavirus
In December 2019, a novel strain of coronavirus,
which causes the disease known as COVID-19, was reported to have surfaced in Wuhan, China. Since then, COVID-19 coronavirus has
spread globally. In March 2020, the World Health Organization declared the COVID-19 outbreak a pandemic and the U.S. government
imposed travel restrictions on travel between the United States, Europe and certain other countries. The impact of this pandemic
has been, and will likely continue to be, extensive in many aspects of society, which has resulted, and will likely continue to
result, in significant disruptions to the global economy as well as businesses and capital markets around the world.
In response to public health
directives and orders and to help minimize the risk of the virus to employees, the Company has taken precautionary measures,
including implementing work-from-home policies for the Company’s employees, other than those in its laboratory, those
performing manufacturing functions and certain other employees as deemed appropriate from time to time. For those employees,
the Company has implemented stringent safety measures designed to comply with applicable federal, state and local guidelines
instituted in response to the COVID-19 pandemic. The Company has taken these and other precautionary steps while maintaining
business continuity in order to continue to progress its programs. While there has been no prolonged material disruption to
the Company’s business to date, the impact of the virus, including work-from-home policies, may negatively impact
productivity, disrupt the Company’s business, and delay its preclinical research and clinical trial activities and its
development program timelines, the magnitude of which will depend, in part, on the length and severity of the restrictions
and other limitations on the Company’s ability to conduct its business in the ordinary course. Other impacts to the
Company’s business may include temporary closures of its suppliers and disruptions or restrictions on its
employees’ ability to travel. Any prolonged material disruption to the Company’s employees or suppliers could
adversely impact the Company’s preclinical research and clinical trial activities, financial condition and results of
operations, including its ability to obtain financing.
7
2. Summary of significant accounting policies
Principles of consolidation
The accompanying consolidated financial
statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP,
and include the accounts of the Company and its direct and indirect wholly owned subsidiaries, Replimune UK, Replimune US, Replimune
Securities Corporation and Replimune (Ireland) Limited after elimination of all intercompany accounts and transactions.
Use of estimates
The preparation of consolidated financial
statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets
and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the
reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in these consolidated
financial statements include, but are not limited to, the accrual for research and development expenses and the valuation of stock-based
awards. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors
that it believes to be reasonable under the circumstances.
The full extent to which the COVID-19 pandemic
will directly or indirectly impact our business, results of operations and financial condition, including, expenses, research and
development costs and employee-related amounts, will depend on future developments that are highly uncertain, including as a result
of new information that may emerge concerning COVID-19 and the actions taken to contain it or treat COVID-19. We have made estimates
of the impact of COVID-19 within our financial statements and there may be changes to those estimates in future periods.
Estimates are periodically reviewed in light
of reasonable changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become
known. Actual results could differ from those estimates or assumptions.
Unaudited interim financial information
The accompanying consolidated balance sheet
as of September 30, 2020, the consolidated statements of operations, of comprehensive loss and of stockholders’ equity for
the three and six months ended September 30, 2020 and 2019 and the consolidated statements of cash flows for the six months ended
September 30, 2020 and 2019 are unaudited. The unaudited interim consolidated financial statements have been prepared on the same
basis as the audited annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which
include only normal recurring adjustments, necessary for the fair presentation of the Company’s financial position as of
September 30, 2020 and the results of its operations for the three and six months ended September 30, 2020 and 2019 and its cash
flows for the six months ended September 30, 2020 and 2019. The financial data and other information disclosed in these consolidated
notes related to the three and six months ended September 30, 2020 and 2019 are unaudited. The results for the three and six months
ended September 30, 2020 are not necessarily indicative of results to be expected for the year ending March 31, 2021, any other
interim periods or any future year or period. The financial information included herein should be read in conjunction with the
financial statements and notes in the Company's Annual Report on Form 10-K for the year ended March 31, 2020.
During the three and six months
ended September 30, 2020, there have been no changes to the Company’s significant accounting policies as described
in the Company's Annual Report on Form 10-K for the year ended March 31, 2020 which was filed with the Securities and Exchange
Commission on June 3, 2020, except as described below.
8
Recently adopted accounting
pronouncements
In August 2018, the FASB issued ASU
No. 2018-13, Fair Value Measurement (Topic 820), Disclosure Framework- Changes to the Disclosure Requirements for
Fair Value Measurement (“ASU 2018-13”). The amendments in this ASU require certain existing disclosure requirements
in Topic 820 to be modified or removed, and certain new disclosure requirements to be added to the Topic. In addition, this ASU
allows entities to exercise more discretion when considering fair value measurement disclosures. The Company adopted ASU 2018-13
on April 1, 2020. The adoption of ASU 2018-13 did not have a material impact on the Company's consolidated financial statements.
In November 2018, the FASB issued ASU No. 2018-18,
Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 (“ASU2018-18”),
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. The standard is effective for interim and annual periods beginning after December 15, 2019,
with early adoption permitted, including adoption in any interim period for public business entities for periods in which financial
statements have not been issued. 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 this Update 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 Company adopted ASU 2018-18 on April 1, 2020. The adoption of ASU 2018-18 did not have
a material impact on the Company's consolidated financial statements.
Recently issued accounting
pronouncements
In June 2016, the FASB issued ASU No. 2016-13, Financial
Instruments- Credit Losses (Topic 326). The standard changes how entities will measure credit losses for most financial
assets and certain other instruments that are not measured at fair value through net income. Financial assets measured at amortized
cost will be presented at the net amount expected to be collected by using an allowance for credit losses. In April 2019,
the FASB issued ASU No. 2019-04, Codification Improvements to Topic 326, Financial Instruments - Credit
Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments, which clarifies and corrects certain
unintended applications of the guidance contained in each of the amended Topics. Additionally, in May 2019, the FASB issued
ASU No. 2019-05, Financial Instruments - Credit Losses (Topic 326), which provides an option
to irrevocably elect to measure certain individual financial assets at fair value instead of amortized cost. The standard is effective
for fiscal years and interim periods beginning after December 15, 2023. Early adoption is permitted for all periods beginning
after December 15, 2018. The adoption of ASU 2016-13 is not expected to have a material impact on the Company's consolidated
financial statements.
3. Fair value of financial assets and liabilities
The following tables present information
about the Company’s financial assets and liabilities measured at fair value on a recurring basis:
9
Fair Value Measurements as of
September 30, 2020 Using:
Level 1
Level 2
Level 3
Total
Assets
Money market funds
$ -
$ 13,437
$ -
$ 13,437
US Treasury bonds
-
111,841
-
111,841
US Government Agency bonds
-
89,479
-
89,479
$ -
$ 214,757
$ -
$ 214,757
Fair Value Measurements as of
March 31, 2020 Using:
Level 1
Level 2
Level 3
Total
Assets
Money market funds
$ -
$ 36,712
$ -
$ 36,712
Commercial paper
-
21,884
-
21,884
US Treasury bonds
-
35,810
-
35,810
US Government Agency bonds
-
15,295
-
15,295
Corporate debt securities
-
36,066
-
36,066
$ -
$ 145,767
$ -
$ 145,767
The underlying securities held in the money
market funds held by the Company are all government backed securities.
During the three and six months ended September
30, 2020 and 2019, there were no transfers between levels.
Valuation of cash equivalents and short-term investments
Money market funds, commercial paper, U.S.
Treasury bonds, U.S. Government Agency bonds and corporate debt securities were valued by the Company using quoted prices in active
markets for similar securities, which represent a Level 2 measurement within the fair value hierarchy. Cash equivalents consisted
of money market funds at September 30, 2020 and March 31, 2020.
4. Short-term investments
Short-term investments by investment type
consisted of the following:
September 30, 2020
Amortized
cost
Gross unrealized
gains
Gross unrealized
losses
Fair value
US Government agency bonds
$ 89,462
$ 19
$ (2 )
$ 89,479
US Treasury bonds
111,778
63
-
111,841
$ 201,240
$ 82
$ (2 )
$ 201,320
March 31, 2020
Amortized
cost
Gross unrealized
gains
Gross unrealized
losses
Fair value
Commercial paper
$ 21,818
$ 66
$ -
$ 21,884
US Government agency bonds
15,217
78
-
15,295
US Treasury bonds
35,590
220
-
35,810
Corporate debt securities
36,107
24
(65 )
36,066
$ 108,732
$ 388
$ (65 )
$ 109,055
10
5. Property, plant and equipment, net
Property, plant and equipment, net consisted
of the following:
September 30,
March 31,
2020
2020
Construction in progress
$ 1,184
$ 1,217
Plant and laboratory equipment
4,616
3,669
Leasehold improvements
736
532
Computer equipment
1,661
1,658
Office equipment
721
721
8,918
7,797
Less: Accumulated depreciation and amortization
(1,752 )
(937 )
$ 7,166
$ 6,860
Depreciation and amortization expense was
$425 and $816 for the three and six months ended September 30, 2020, respectively, and $42 and $84 for the three and six months
ended September 30, 2019, respectively. Depreciation and amortization expense are recorded within research and development and
general and administrative expenses in the consolidated statement of operations.
6. Accrued expenses and other current liabilities
Accrued expenses and other current liabilities
consisted of the following:
September 30,
March 31,
2020
2020
Accrued research and development costs
$ 3,983
$ 2,009
Accrued compensation and benefits costs
1,845
2,065
Accrued professional fees
443
779
Other
974
303
$ 7,245
$ 5,156
7. Long-term debt
Long-term debt consisted of the following:
September 30,
March 31,
2020
2020
Principal amount of long-term debt
$ 10,000
$ 10,000
Unamortized debt discount
(173 )
(199 )
Long-term debt, net of discount
$ 9,827
$ 9,801
Hercules Loan Agreement
On August 8, 2019, (the “Closing
Date”) the Company and certain of its affiliates entered into a Loan and Security Agreement (as amended, the “Hercules
Loan Agreement”) with Hercules Capital, Inc. (“Hercules”) pursuant to which Hercules agreed to make available
to the Company a secured term loan facility in the amount of $30,000 (the “Term Loan Facility”), subject to certain
terms and conditions. The Company borrowed $10,000 under the Hercules Loan Agreement in one advance as a single tranche Term Loan
on the Closing Date upon which the Company paid a $225 facility charge and incurred $130 in additional closing and legal fees.
The Company may borrow the unused $20,000 available under the Term Loan Facility in two separate advances. The second advance of
up to $10,000 may be borrowed between January 1, 2020 and December 15, 2020 and the third advance of up to $10,000 may
be borrowed between July 1, 2020 and June 30, 2021.
On
June 1, 2020, the Company entered into the First Amendment to the Hercules Loan Agreement (the “Hercules First
Amendment”), to, among other things, increase the aggregate principal amount of the secured term loan facility from
$30,000 to $40,000 , by adding a fourth advance of up to $10,000. Pursuant to the Hercules First Amendment, the Company
may borrow the second advance of $10,000 between October 1, 2020 and December 15, 2020. In the event the Company does not
draw on the second advance or if the Term Loan Facility is terminated prior to a draw of the second advance, the Company
shall pay Hercules a one-time facility charge fee of $100 on the earliest of (i) December 16, 2020 or (ii) the date the
Company prepays the outstanding obligations. The third advance of up to $10,000 may be borrowed between July 1, 2020 and June
30, 2021. The fourth advance of up to $10,000 may be borrowed between July 1, 2021 and December 15, 2021. The Company
incurred $100 in additional closing and legal fees in connection with Hercules First Amendment which were capitalized and
will be amortized as part of the effective yield. Additionally, the Hercules First Amendment extended the interest only
payment period from March 1, 2022 to September 1, 2022 (the “Amortization Date”).
11
Advances under the Term Loan Facility bear
interest at a rate per annum equal to the greater of either (i) the prime rate as reported in The Wall Street Journal plus
2.75%, or (ii) 8.75%. The Hercules Loan Agreement includes covenants, limitations, and events of default customary for similar
facilities. The term of the Hercules Loan Agreement is four years, ending August 1, 2023.
Interest is payable on a monthly basis until
the Amortization Date. After the Amortization Date, payments shall consist of equal monthly installments of principal and interest
payable until the secured obligations are repaid in full.
At any time the Company may prepay the principal
of any advance pursuant to the terms of the Term Loan Facility subject to a prepayment charge equal to: 3.0%, if such advance is
prepaid within the first twelve months following the Closing Date, 2.0%, if such advance is prepaid after twelve months but prior
to twenty four months following the Closing Date, and 1.0%, if such advance is prepaid anytime thereafter. The Company will also
pay a charge equal to the product of 4.95% and the aggregate amount of any advance made pursuant to the terms of the Term Loan
Facility.
The Term Loan Facility is secured by substantially
all of the Company’s assets, but excluding its intellectual property, and subject to certain exceptions and exclusions.
The Hercules Loan Agreement contains customary
covenants for transactions of this type and other covenants agreed to by the parties, including, among others, (i) the provision
of delivery of annual and quarterly financial statements and insurance policies and restrictions on incurring debt, granting liens,
making acquisitions, making loans, paying dividends, dissolving, and entering into leases and asset sales. The Hercules Loan Agreement
also provides for customary events of default, including, among others, events of default relating to failure to make payment,
bankruptcy, breach of covenants, breaches of representations and warranties, change of control, judgment and material adverse effects.
In connection with entering into the Hercules
Loan Agreement, the Company paid Hercules $355 of upfront fees, including closing costs and legal fees associated with entering
into the agreement, which were recorded as a debt discount. In connection with entering into the Hercules First Amendment, the
Company paid $100 of upfront fees, including closing costs and legal fees associated with entering into the amendment, which were
recorded as debt discount, totaling the debt discount to $455 as of September 30, 2020. The debt discount is reflected as a reduction
of the carrying value of long-term debt on the Company’s consolidated balance sheet and is being amortized to interest expense
over the term of the loan using the effective interest method.
The
Company recognized aggregate interest expense under the Hercules Loan Agreement of $286 and $570 during the three and six
months ended September 30, 2020, respectively, which included non-cash interest expense of $63 and $126 for the three and six months
ended September 30, 2020, respectively, $29 and $56 related to the accretion of the debt discount and $34 and $70 related to the
accretion of the final payment for the three and six months ended September 30, 2020, respectively. The Company’s annual
effective interest rate under the Hercules Loan Agreement (after giving effect to the Hercules First Amendment) was approximately
10.5% as of September 30, 2020.
There were no principal payments due or
paid under the Hercules Loan Agreement during the three and six months ended September 30, 2020.
12
Future payments of long-term debt
as of September 30, 2020 are as follows (fiscal years):
Future long-term debt payments:
2021 (remaining six months) $
-
2022
-
2023
5,722
2024
4,278
Total debt payments $
10,000
The table of future payments of long-term
debt excludes the end of term charge of $495 as of September 30, 2020, which is due upon the maturity of the loan.
8. Stockholders’ Equity
Common stock
As of September 30, 2020 and March 31, 2020,
the Company’s certificate of incorporation, as amended and restated, authorized the Company to issue up to 150,000,000 shares
of common stock, par value $0.001 per share.
As of September 30, 2020 and March 31, 2020,
the Company had reserved 13,638,824 and 10,449,033 shares of common stock for the exercise of outstanding stock options, the number
of shares remaining available for grant under the Company’s 2018 Omnibus Incentive Compensation Plan and the Company’s
Employee Stock Purchase Plan (see Note 9) and the exercise of the outstanding warrants to purchase shares of common, respectively.
Undesignated preferred
stock
As of September 30, 2020, the Company’s
certificate of incorporation, as amended and restated, authorized the Company to issue up to 10,000,000 shares of undesignated
preferred stock, par value $0.001 per share. There were no undesignated preferred shares issued or outstanding as of September 30,
2020.
Convertible preferred stock and preferred
stock warrants
Prior to the IPO, the Company
issued series seed convertible preferred stock (the “series seed preferred stock”), series A convertible preferred
stock (the “series A preferred stock”) and series B convertible preferred stock (the “series B preferred stock”).
The series seed preferred stock, series A preferred stock and series B preferred stock are collectively referred to as the “preferred
stock.” In connection with the closing of the IPO, the preferred stock converted into 19,157,360 shares of common stock on
a 1:9.94688 basis. There was no preferred stock outstanding as of September 30, 2020 and March 31, 2020.
In
connection with the issuance of the series seed preferred stock, the Company issued to the holders of the series seed preferred
stock warrants for the purchase of 50,000 shares of series seed preferred stock, which became fully vested and exercisable in the
year of issuance. The warrants to purchase shares of series seed preferred stock were issued at an exercise price of $10.00 per
share and expire on the earlier of September 16, 2025 or a qualified change of control event. In connection with the closing
of the IPO , the series seed preferred stock warrants became exercisable for 497,344 shares of common stock and the exercise price
was adjusted to $1.01 per share. Upon the closing of the IPO, the series seed preferred stock warrants and were reclassified to
stockholders’ equity. The warrants to purchase 497,344 shares of common stock remain outstanding as of September 30,
2020.
13
ATM program
In August 2019, the
Company entered into a Sales Agreement (as amended, the “2019 Sales Agreement”) with SVB Leerink LLC (the
“Agent”), pursuant to which the Company could sell, from time to time, at its option, up to an aggregate amount
of $75,000 of shares of the Company’s common stock, $0.001 par value per share, through the Agent, as the
Company’s sales agent. In June 2020, the 2019 Sales Agreement was amended to reduce the aggregate offering amount under
the 2019 Sales Agreement from $75,000 of shares to $30,000 of shares.
On August 11, 2020, the 2019 Sales
Agreement was terminated by the execution by the Company and the Agent of a new sales agreement (the “2020 Sales Agreement”).
Under the 2020 Sales Agreement the Company may sell, from time to time, at its option, up to an aggregate of $75,000 of shares
of the Company’s common stock, $0.001 par value per share (the “Shares”), through the Agent, as the Company’s
sales agent. On October 21, 2020, the 2020 Sales Agreement was amended to reduce the aggregate offering amount under the
2020 Sales Agreement from $75,000 of Shares to $62,500 of Shares (Note 14).
Any Shares to be offered and sold
under the 2020 Sales Agreement will be issued and sold (i) by methods deemed to be an “at the market offering” (“ATM”)
as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended or in negotiated transactions, if authorized
by the Company and (ii) pursuant to, and only upon the effectiveness of, a registration statement on Form S-3 filed by the Company
with the Securities and Exchange Commission on August 11, 2020 for an offering of up to $350,000 of various securities, including
shares of the Company’s common stock, preferred stock, debt securities, warrants and/or units for sale to the public in one
or more public offerings.
Subject to the terms of the 2020
Sales Agreement, the Agent will use reasonable efforts to sell the Shares from time to time, based upon the Company’s instructions
(including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company cannot
provide any assurances that it will issue any Shares pursuant to the 2020 Sales Agreement. The Company will pay the Agent a commission
of up to 3.0% of the gross proceeds from the sale of the Shares, if any. The Company has also agreed to provide the Agent with
customary indemnification rights.
During the year ended March 31,
2020, the Company issued and sold 287,559 shares of common stock under the 2019 Sales Agreement, for gross proceeds of $4,568 less
offering fees of $137 for net proceeds of $4,431 under the ATM. The Company has not issued and sold any shares under the 2020 Sales
Agreement as of September 30, 2020.
Equity offerings
In November 2019, the Company
entered into an Underwriting Agreement (the “November 2019 Underwriting Agreement”) with J.P. Morgan Securities LLC
and SVB Leerink LLC, as representatives of the several underwriters named therein (the “November 2019 Underwriters”),
relating to the issuance and sale of an aggregate of (a) 3,678,031 shares of the Company’s common stock (the “November
2019 Shares”), and (b) pre-funded warrants to purchase 2,200,000 shares of the Company’s common stock (the “November
2019 Pre-Funded Warrants”) to the Underwriters (the “November 2019 Offering”). The November 2019 Shares
were sold to the purchasers at the public offering price of $13.61 per share. The November 2019 Pre-Funded Warrants were sold at
a public offering price of $13.6099 per November 2019 Pre-Funded Warrant, which represents the per share public offering price
for the Company’s common stock less a $0.0001 per share exercise price for each such November 2019 Pre-Funded Warrant. In
December 2019, the November 2019 Underwriters partially exercised their purchase option pursuant to the Underwriting Agreement,
and the Company issued and sold an additional 838,530 shares of its common stock. The Company received aggregate net proceeds
of approximately $85,598 in the November 2019 Offering, after deducting underwriting discounts, commissions and other
offering expenses payable by the Company of approximately $5,814.
Funds affiliated with Redmile Group,
LLC purchased all of the November 2019 Pre-Funded Warrants. The November 2019 Pre-Funded Warrants are exercisable at any time after
the date of issuance. A holder of November 2019 Pre-Funded Warrants may not exercise the November 2019 Pre-Funded Warrant if the
holder, together with its affiliates, would beneficially own more than 9.99% of the number of shares of the Company’s common
stock outstanding immediately after giving effect to such exercise. A holder of November 2019 Pre-Funded Warrants may increase
or decrease this percentage to any other percentage by providing at least 61 days’ prior notice to the Company. As of
September 30, 2020, none of the November 2019 Pre-Funded Warrants had been exercised.
14
In June 2020, the Company entered
into a separate Underwriting Agreement (the “June 2020 Underwriting Agreement”) with J.P. Morgan Securities LLC and
SVB Leerink LLC, as representatives of the several underwriters named therein (the “June 2020 Underwriters”), relating
to the issuance and sale of an aggregate of (a) 2,826,088 shares of the Company’s common stock (the “June 2020
Shares”), and (b) pre-funded warrants to purchase 1,521,738 shares of the Company’s common stock (the “June
2020 Pre-Funded Warrants”) to the Underwriters (the “June 2020 Offering”). The June 2020 Shares were sold
to the purchasers at the public offering price of $23.00 per share. The June 2020 Pre-Funded Warrants were sold at a public offering
price of $22.9999 per June 2020 Pre-Funded Warrant, which represents the per share public offering price for the Company’s
common stock less a $0.0001 per share exercise price for each such June 2020 Pre-Funded Warrant. The June 2020 Underwriters fully
exercised their purchase option pursuant to the June 2020 Underwriting Agreement, and the Company issued and sold an additional
652,173 shares of its common stock. The Company received aggregate net proceeds of approximately $107,782 after
deducting underwriting discounts, commissions and other offering expenses payable by the Company of approximately $7,217.
Funds affiliated with Redmile Group,
LLC and funds affiliated with a second institutional investor purchased all of the June 2020 Pre-Funded Warrants. The June 2020
Pre-Funded Warrants are exercisable at any time after the date of issuance. A holder of June 2020 Pre-Funded Warrants may not exercise
the June 2020 Pre-Funded Warrant if the holder, together with its affiliates, would beneficially own more than 9.99% of the number
of shares of the Company’s common stock outstanding immediately after giving effect to such exercise. A holder of June 2020
Pre-Funded Warrants may increase or decrease this percentage up to 19.99% by providing at least 61 days’ prior notice to
the Company. As of September 30, 2020, none of the June 2020 Pre-Funded Warrants had been exercised.
Other
than as set forth in Note 10 to these consolidated financial statements, including in the calculation of basic and diluted
net loss per share attributable to common stockholders, the 3,721,738 shares of the Company’s common stock into which the
November 2019 Pre-Funded Warrants and the June 2020 Pre-Funded Warrants are exercisable are not included in the number of issued
and outstanding shares of the Company’s common stock set forth herein.
9. Stock-based compensation
2015 Enterprise Management
Incentive Share Option Plan
The 2015 Enterprise Management Incentive
Share Option Plan of Replimune UK (the “2015 Plan”) provided for Replimune UK to grant incentive stock options, non-statutory
stock options, stock awards, stock units, stock appreciation rights and other stock-based awards. Incentive stock options are granted
only to the Company’s employees, including officers and directors who are also employees. Non-statutory stock options are
granted to employees, members of the board of directors, outside advisors and consultants of the Company.
2017 Equity Compensation
Plan
In July 2017, in conjunction with the Reorganization,
the 2015 Plan was terminated, and all awards were cancelled with replacement awards issued under the 2017 Equity Compensation Plan
(the “2017 Plan”). Subsequent to the Reorganization, no additional grants will be made under the 2015 Plan and any
outstanding awards under the 2015 Plan will continue with their original terms. The Company concluded that the cancellation of
the 2015 Plan and issuance of replacement awards under the 2017 Plan was a modification with no change in the material rights and
preferences and therefore no recorded change in the fair value of each respective award.
The Company’s 2017 Plan provides
for the Company to grant incentive stock options or non-statutory stock options, stock awards, stock units, stock
appreciation rights and other stock-based awards. Incentive stock options may be granted only to the Company’s
employees, including officers and directors who are also employees. Restricted stock awards and non-statutory stock options
may be granted to employees, officers, members of the board of directors, advisors and consultants of the Company. The
maximum number of common shares that may be issued under the 2017 Plan was 2,659,885 of which 0 remained available for future
grants as of September 30, 2020. Shares with respect to which awards have expired, terminated, surrendered or cancelled
under the 2017 Plan without having been fully exercised will be available for future awards under the 2017 Plan. In addition,
shares of common stock that are tendered to the Company by a participant to exercise an award are added to the number of
shares of common stock available for the grant of awards.
15
2018 Omnibus Incentive
Compensation Plan
On July 9, 2018, the Company’s
board of directors adopted, and the Company’s stockholders approved the 2018 Omnibus Incentive Compensation Plan (the “2018
Plan”), which became effective immediately prior to the effectiveness of the registration statement for the Company’s
initial public offering. The 2018 Plan provides for the issuance of incentive stock options, non-qualified stock options, stock
awards, stock units, stock appreciation rights and other stock-based awards. The number of shares initially reserved for issuance
under the 2018 Plan is 3,617,968 shares. If any options or stock appreciation rights, including outstanding options and stock appreciation
rights granted under the 2017 Plan (up to 2,520,247 shares), terminate, expire, or are canceled, forfeited, exchanged, or surrendered
without having been exercised, or if any stock awards, stock units or other stock-based awards, including outstanding awards granted
under the 2017 Plan, are forfeited, terminated, or otherwise not paid in full in shares of common stock, the shares of the Company’s
common stock subject to such grants will be available for purposes of our 2018 Plan. On April 1, 2020, the number of shares
reserved for issuance under the 2018 Plan automatically increased by 1,466,749 shares pursuant to the terms of the 2018 Plan. On
April 1, 2019, the number of shares reserved for issuance under the 2018 Plan automatically increased by 1,266,278 shares
pursuant to the terms of the 2018 Plan. As of September 30, 2020, 1,722,528 shares remained available for future grants under
the 2018 Plan.
The 2015 Plan, the 2017 Plan and the 2018
Plan was administered by the board of directors or, at the discretion of the board of directors, by a committee of the board of
directors. However, the board of directors shall administer and approve all grants made to non-employee directors. The exercise
prices, vesting and other restrictions are determined at the discretion of the board of directors, except that the exercise price
per share of incentive stock options may not be less than 100% of the fair market value of the common stock on the date of grant
(or 110% of fair value in the case of an award granted to employees who hold more than 10% of the total combined voting power of
all classes of stock at the time of grant) and the term of stock options may not be greater than five years for an incentive stock
option granted to a 10% stockholder and greater than ten years for all other options granted. Stock options awarded under both
plans expire ten years after the grant date, unless the board of directors sets a shorter term. Vesting periods for both plans
are determined at the discretion of the board of directors. Incentive stock options granted to employees and non-statutory options
granted to employees, officers, members of the board of directors, advisors, and consultants of the Company typically vest over
four years.
Employee Stock Purchase
Plan
On July 9, 2018, the Company’s board
of directors adopted and the Company’s stockholders approved the Employee Stock Purchase Plan (the “ESPP”), which
became effective immediately prior to the effectiveness of the registration statement for the Company’s IPO. The total shares
of common stock initially reserved for issuance under the ESPP is limited to 348,612 shares. In addition, as of the first trading
day of each fiscal year during the term of the ESPP (excluding any extensions), an additional number of shares of the Company’s
common stock equal to 1% of the total number of shares outstanding on the last trading day in the immediately preceding fiscal
year or 697,224 shares, whichever is less (or such lesser amount as determined by the Company’s board of directors) will
be added to the number of shares authorized under the ESPP. In accordance, on April 1, 2020 and 2019, the number of shares reserved
for issuance under the ESPP automatically increased by 366,687 and 316,569 shares respectively, for a total of 1,031,868 shares
reserved for the ESPP. If the total number of shares of common stock to be purchased pursuant to outstanding purchase rights on
any particular date exceed the number of shares then available for issuance under the ESPP, then the plan administrator will allocate
the available shares pro-rata and refund any excess payroll deductions or other contributions to participants. The Company’s
ESPP is not currently active.
Stock option valuation
The fair value of stock option grants
is estimated using the Black-Scholes option-pricing model. The Company lacks company-specific historical and implied
volatility information. Therefore, it estimated its expected stock volatility based on the historical volatility of a
publicly traded set of peer companies. For options with service-based vesting conditions, the expected term of the
Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as
“plain-vanilla” options. The expected term of stock options granted to non-employees is equal to the contractual
term of the option award. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect
at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend
yield is based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in
the foreseeable future.
16
The
following table presents, on a weighted-average basis, the assumptions that the Company used to determine the grant-date fair value
of stock options granted to employees and directors:
Three Months Ended
September 30,
Six Months Ended
September 30,
2020
2019
2020
2019
Risk-free interest rate
0.33 %
1.68 %
1.08 %
2.30 %
Expected term (in years)
6.1
6.1
6.4
6.0
Expected volatility
75.3 %
70.2 %
74.6 %
71.4 %
Expected dividend yield
0 %
0 %
0 %
0 %
Stock options
The
following table summarizes the Company’s stock option activity:
Weighted
Weighted
Average
Average
Aggregate
Number of
Exercise
Contractual
Intrinsic
Shares
Price
Term (Years)
Value
Outstanding as of March 31, 2020
4,964,381
$ 9.78
8.02
$ 15,344
Granted
2,081,504
12.52
9.57
Exercised
(165,268 )
11.19
Cancelled
(215,271 )
12.38
Outstanding as of September 30, 2020
6,665,346
10.52
8.14
$ 83,329
Options exercisable as of March 31, 2020
2,117,721
$ 5.66
7.20
$ 11,733
Options exercisable as of September 30, 2020
3,894,669
$ 12.82
7.02
$ 43,583
The aggregate intrinsic value of stock options
is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common
stock for those stock options that had exercise prices lower than the fair value of the Company’s common stock.
The weighted average grant-date fair value
per share of stock options granted during the six months ended September 30, 2020 and 2019 was $8.28 and $9.82, respectively.
The total fair value of options vested during the three months and six months ended September 30, 2020 was $1,628 and $6,261, respectively.
The total fair value of options vested during the three months and six months ended September 30, 2019 was $3,206 and $3,417, respectively.
17
Stock-based compensation expense
Stock-based compensation expense was classified
in the consolidated statements of operations as follows:
Three Months Ended
Six Months Ended
September 30,
September 30,
2020
2019
2020
2019
Research and development
$ 1,298
$ 815
$ 2,297
$ 1,656
General and administrative
1,503
966
2,972
1,935
$ 2,801
$ 1,781
$ 5,269
$ 3,591
As of September 30, 2020, total unrecognized
compensation cost related to the unvested stock-based awards was $29,049, which is expected to be recognized over a weighted average
period of 2.96 years.
10. Net loss per share
Basic and diluted net loss per share attributable
to common stockholders was calculated as follows:
Three Months Ended
September 30,
Six Months Ended
September 30,
2020
2019
2020
2019
Numerator:
Net loss attributable to common stockholders
$ (20,095 )
$ (11,139 )
$ (37,588 )
$ (20,647 )
Denominator:
Weighted average common shares outstanding, basic and diluted
44,015,786
31,675,323
41,950,401
31,668,414
Net loss per share attributable to common stockholders, basic and diluted
$ (0.46 )
$ (0.35 )
$ (0.90 )
$ (0.65 )
The
November 2019 Pre-Funded Warrants and the June 2020 Pre-Funded Warrants are included in the calculation of basic and diluted
net loss per share attributable to common stockholders. The Company’s potentially dilutive securities, which include stock
options, preferred stock and warrants to purchase shares of series seed preferred stock, have been excluded from the computation
of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted average number of
common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the
same. The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from
the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them
would have had an anti-dilutive effect:
Three and Six Months Ended
September 30,
2020
2019
Options to purchase common stock
6,665,346
4,739,336
Warrants to purchase convertible preferred stock (as converted to common stock)
497,344
497,344
7,162,690
5,236,680
11. Significant agreements
Agreement with Bristol-Myers
Squibb Company
In February 2018, the Company entered into
an agreement with Bristol-Myers Squibb Company (“BMS”). Pursuant to the agreement, BMS will provide to the Company,
at no cost, a compound for use in the Company’s ongoing clinical trial. Under the agreement, the Company will sponsor, fund
and conduct the clinical trial in accordance with an agreed-upon protocol. BMS granted the Company a non-exclusive, non-transferrable,
royalty-free license (with a right to sublicense) under its intellectual property to its compound in the clinical trial and agreed
to supply its compound, at no cost to the Company, for use in the clinical trial. In January 2020, this agreement was expanded
to cover an additional cohort of 125 patients with anti-PD-1 failed melanoma.
18
Unless earlier terminated, the agreement
will remain in effect until (i) the completion of the clinical trial, (ii) all related clinical trial data have been
delivered to both parties and (iii) the completion of any statistical analyses and bioanalyses contemplated by the clinical
trial protocol or any analysis otherwise agreed upon by the parties. The agreement may be terminated by either party (i) in
the event of an uncured material breach by the other party, (ii) in the event the other party is insolvent or in bankruptcy
proceedings or (iii) for safety reasons. Upon termination, the licenses granted to the Company to use BMS’s compound
in the clinical trial will terminate.
In April 2019, the Company entered
into a separate agreement with BMS on terms similar to the terms set forth in the agreement described above, pursuant to which
BMS will provide to the Company, at no cost, nivolumab for use in the Company’s Phase 1 clinical trial of RP2 in combination
with nivolumab.
As of September 30, 2020, the Company had
not incurred any costs and does not expect to incur future costs in connection with this agreement.
Agreement
with Regeneron Pharmaceuticals, Inc .
In May 2018, the Company entered into an
agreement with Regeneron Pharmaceuticals, Inc. (“Regeneron”). The Company and Regeneron are each independently
developing compounds for the treatment of certain tumor types. Pursuant to the agreement, the Company and Regeneron will undertake
one or more clinical trials using a combination of the compounds being developed by each entity. Under the agreement, each study
will be conducted under terms set out in a separately agreed upon study plan that will identify the name of the sponsor and which
party will manage the particular clinical trial, and include the protocol, the budget and a schedule of clinical obligations. In
June 2018, under the terms of the agreement between the Company and Regeneron, the parties agreed to the first study plan. The
Company and Regeneron have agreed to the protocol, budget, sample testing and clinical obligations schedule under the study plan.
Development and supply costs associated with the study plan will be split equally between the Company and Regeneron.
Pursuant to the terms of the agreement,
each party granted the other party a non-exclusive license under its respective intellectual property and agreed to contribute
the necessary resources needed to fulfill its respective obligations, in each case, under the terms of the agreed-upon or to-be
agreed upon study plans. Development costs of a particular clinical trial will be split equally between the Company and Regeneron.
The agreement may be terminated by either
party if (i) there is no active study plan for which a final study report has not been completed, (ii) the parties have
not entered into a study plan for an additional clinical trial within a period of time after the delivery of the most recent final
study report or (iii) in the event of a material breach.
The Company will account for costs incurred
as part of the study, including costs to supply compounds for use in the study, as research and development expenses within the
consolidated statement of operations. The Company will recognize any amounts received from Regeneron in connection with this agreement
as an offset to research and development expense within the consolidated statement of operations.
Under the terms of the agreement, on a quarterly
basis the Company and Regeneron true-up costs of the study and make corresponding payments to the party that incurred the majority
of the costs. During the three and six months ended September 30, 2020 or 2019, the Company did not make any payments under
the terms of the agreement to Regeneron. During the three and six months ended September 30, 2020, the Company received
payments under the terms of the agreement to Regeneron of $1,433 and $2,404, respectively. During the three and six months
ended September 30, 2019, the Company received payments under the terms of the agreement to Regeneron of $337 and $912, respectively.
As of September 30, 2020 and March 31, 2020, the Company recorded $1,453 and $971 of receivables from Regeneron in connection
with this agreement in prepaid expenses and other current assets in the consolidated balance sheet, respectively.
19
12. Commitments and contingencies
Leases
In April 2016, the Company entered into
a lease agreement for office and laboratory space in Abingdon, England. On June 29, 2020 the Company modified the lease terms to
extend the expiration date to April 3, 2031 and the lease modification was not accounted for as a separate contract. As part of
the lease modification, the lease liability was remeasured in accordance with the updated terms of the contract and the associated
lease liability and right-of-use asset was increased by $1,580. The Company has the right to terminate the lease as of April 4,
2026 upon at least twelve months’ prior written notice. Monthly lease payments are inclusive of base rent, ancillary charges,
non-rent shared tenant occupancy costs and the respective value added tax to be paid. Monthly lease payments include base rent
of approximately $29 through June 23, 2020, $14 from June 24, 2020 through December 24, 2020, and $29 thereafter. Monthly base
rent is subject to increase after April 2021 in proportion to the Retail Price Index or market rates. The lease is classified as
an operating lease.
In June 2018, the Company entered into an
agreement to lease approximately 63,000 square feet of office, manufacturing and laboratory space in Framingham, Massachusetts.
Pursuant to the lease agreement, the lease term commenced in December 2018, subject to the landlord completing certain agreed upon
landlord improvements. The rent commencement date started in August 2019. The initial lease term is ten years from the rent commencement
date and includes two optional five-year extensions. Annual lease payments during the first year were $2,373 with increases of
3.0% each year thereafter until the expiration of the lease.
Construction was completed associated with
approximately 10,500 square feet of the leased space in Framingham, Massachusetts and the Company occupied the building as office
space beginning August 1, 2019. The Company recorded a right-of-use asset and lease liability associated with the occupied
space as of August 1, 2019. The Company recorded $2,368 in related construction costs to the right-of-use asset upon the lease
commencement date which were reclassified from prepaid rent. The Company occupied the remainder of the facility, approximately
52,500 square feet used as laboratory space, on October 22, 2019. The Company recorded a right-of-use asset and lease
liability associated with the remaining space as of October 22, 2019. The Company recorded $18,164 in related construction costs
and $261 in rent payments made prior to the lease commencement date to the right-of-use asset upon the lease commencement date
which were reclassified from prepaid rent. The lease is classified as a financing lease.
In June 2019, the Company entered into
an agreement to lease approximately 18,700 square feet of office space in Woburn, Massachusetts. Pursuant to the lease agreement,
the lease term commenced in August 2019. The rent commenced in September 2019. The initial lease term is ten years from
the rent commencement date and includes an optional five-year extension. Annual lease payments during the first year are $488 with
increases of approximately 1.6% each year. The Company recorded a right-of-use asset and a lease liability of $4,363 upon the commencement
date of the lease and the lease is classified as an operating lease.
The Company determines if an arrangement
is a lease at inception. Operating leases are included in our balance sheet as right-to-use—operating leases, operating lease
liabilities, current and operating lease liabilities, non-current. Finance leases are included in the balance sheet as right-to-use
asset—finance lease finance lease liabilities, current, and finance lease liabilities, non-current. Certain of the Company’s
lease agreements contain renewal options; however, the Company does not recognize right-of-use assets or lease liabilities for
renewal periods unless it is determined that the Company is reasonably certain of renewing the lease at inception or when a triggering
event occurs. As the Company’s leases do not provide an implicit rate, the Company estimated the incremental borrowing rate
in calculating the present value of the lease payments. Since the Company elected to account for each lease component and its associated
non-lease components as a single combined lease component, all contract consideration was allocated to the combined lease component.
Some of the Company’s lease agreements contain rent escalation clauses (including index-based escalations). The Company recognizes
the minimum rental expense on a straight-line basis based on the fixed components of a lease arrangement. The Company amortizes
this expense over the term of the lease beginning with the date of initial possession, which is the date the Company can enter
the leased space and begin to make improvements in preparation for its intended use. Variable lease components represent amounts
that are not fixed in nature and are not tied to an index or rate, and are recognized as incurred.
20
Three Months Ended
September 30,
Six Months Ended
September 30,
2020
2019
2020
2019
Lease cost
Finance lease costs:
Amortization of right-to-use asset
$ 607
$ -
$ 1,214
$ -
Interest on lease liabilities
562
-
1,123
-
Operating lease costs
237
378
467
492
Total lease cost
$ 1,406
$ 378
$ 2,804
$ 492
Finance lease costs of $89 and $60 are recognized
in general and administrative expenses for the three months ended September 30, 2020 and 2019, respectively, and $179 and $149 for
the six months ended September 30, 2020 and 2019, respectively. Finance lease costs of $518 and $0 are recognized in research and
development expenses for the three months ended September 30, 2020 and 2019, respectively, and $1,035 and $0 for the six months
ended September 30, 2020 and 2019, respectively. Operating leases costs are recognized in general and administrative expenses for
the three and six months ended September 30, 2020 and 2019. The following table summarizes the maturity of the Company’s
lease liabilities on an undiscounted cash flow basis and a reconciliation to the operating and financing lease liabilities recognized
on our balance sheet as of September 30, 2020:
Maturity
lease liabilities
September 30, 2020
Operating leases
Financing lease
Total
2021 (remaining six months)
$ 425
$ 1,222
$ 1,647
2022
945
2,487
3,432
2023
955
2,562
3,517
2024
964
2,639
3,603
2025
973
2,718
3,691
Thereafter
4,924
43,704
48,628
Total lease payments
9,186
55,332
64,518
Less: interest
3,113
27,997
31,110
Total lease liabilities
$ 6,073
$ 27,335
$ 33,408
21
The following table provides lease disclosure
as of September 30, 2020 and March 31, 2020:
September 30, 2020
March 31, 2020
Leases
Right-to-use operating lease asset
$ 5,830
$ 4,425
Right-to-use finance lease asset
45,736
46,925
Total lease assets
$ 51,566
$ 51,350
Operating lease liabilities, current
$ 896
$ 873
Finance lease liabilities, current
2,450
2,411
Operating lease liabilities, non-current
5,177
3,737
Finance lease liabilities, non-current
24,885
24,967
Total lease liabilities
$ 33,408
$ 31,988
The
following table provides lease disclosure for the six months ended September 30, 2020 and 2019:
Six
Months Ended
September 30,
2020
2019
Other
information
Cash
paid for amounts included in the measurement of lease liabilities:
Operating
cash flows from operating leases
$ 391
$ 327
Operating
cash flows from finance leases
$ 1,122
$ -
Financing
cash flows from finance leases
$ 42
$ -
Right-to-use
asset obtained in exchange for new operating lease liabilities
$ 1,580
$ 5,152
Weighted-average
remaining lease term - operating leases
9.3 years
8.7 years
Weighted-average
remaining lease term - financing leases
18.8 years
19.8 years
Weighted-average
discount rate - operating leases
9.6 %
8 %
Weighted-average
discount rate - financing leases
8.3 %
7 %
The variable lease costs and short-term lease costs
were insignificant for three and six months ended September 30, 2020 and 2019.
Manufacturing commitments
The Company has entered into an agreement
with a contract manufacturing organization to provide clinical trial products. As of September 30, 2020 and March 31, 2020, the
Company had committed to minimum payments under these arrangements totaling $2,137 and $3,569, respectively, through March 31,
2021.
Indemnification agreements
In the ordinary course of business, the
Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect
to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property
infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of
its board of directors that will require the Company, among other things, to indemnify them against certain liabilities that may
arise by reason of their status or service as directors or officers. The maximum potential amount of future payments the Company
could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred
any material costs as a result of such indemnifications. The Company is not aware of any claims under indemnification arrangements,
and therefore it has not accrued any liabilities related to such obligations in its consolidated financial statements as of September
30, 2020 or March 31, 2020.
Legal proceedings
The Company is not a party to any litigation
and does not have contingency reserves established for any litigation liabilities.
22
13. Geographic information
The Company operates in two geographic regions:
the United States (Massachusetts) and the United Kingdom (Oxfordshire). Information about the Company’s long-lived assets
held in different geographic regions is presented in the tables below:
September 30, 2020
March 31, 2020
United States
$ 6,610
$ 6,357
United Kingdom
556
503
$ 7,166
$ 6,860
14. Subsequent events
On October 26, 2020, pursuant to an underwriting
agreement with J.P. Morgan Securities LLC and SVB Leerink LLC, as representatives of the several underwriters named therein, the
Company issued and sold to the underwriters (a) 5,625,000 shares of the Company’s common stock, inclusive of the underwriters
30-day option to purchase up to an additional 937,500 shares of the Company’s common stock, and (b) pre-funded warrants
to purchase 1,562,500 shares of the Company’s common stock. The shares of the Company’s common stock were sold to the
underwriters at the public offering price of $40.00 per share and the pre-funded warrants were sold at a public offering price
of $39.99 per warrant share, which represents the per share public offering price for the Company’s common stock less a $0.0001
per share exercise price for each such pre-funded warrant.
The Company received aggregate net proceeds
of approximately $270 million after deducting underwriting discounts, commissions and other offering expenses payable by the
Company.
23
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.