FORM 10-Q
|
Delaware
|
|
81-3467528
|
(State or Other Jurisdiction of Incorporation or Organization)
|
|
(IRS Employer Identification No.)
|
|
|
|
200 Technology Square
Cambridge, Massachusetts
|
|
02139
|
(Address of Principal Executive Offices)
|
|
(Zip Code)
|
Title of each class
|
Trading symbol(s)
|
Name of each exchange on which registered
|
Common stock, par value $0.0001 per share
|
MRNA
|
The NASDAQ Stock Market LLC
|
Large accelerated filer o
|
|
Accelerated filer o
|
|
Non-accelerated filer x
|
|
Smaller reporting company o
|
|
|
|
|
|
|
Emerging growth company x
|
•
|
the initiation, timing, progress, results, safety and efficacy, and cost of our research and development programs and our current and future preclinical studies and clinical trials, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, and our research and development programs;
|
•
|
our anticipated next steps for our development candidates and investigational medicines;
|
•
|
our ability to identify research priorities and apply a risk-mitigated strategy to efficiently discover and develop development candidates and investigational medicines, including by applying learnings from one program to our other programs and from one modality to our other modalities;
|
•
|
our ability and the potential to successfully manufacture our drug substances, delivery vehicles, development candidates, and investigational medicines for preclinical use, for clinical trials and on a larger scale for commercial use, if approved;
|
•
|
the ability and willingness of our third-party strategic collaborators to continue research and development activities relating to our development candidates and investigational medicines;
|
•
|
our ability to obtain funding for our operations necessary to complete further development and commercialization of our investigational medicines;
|
•
|
our ability to obtain and maintain regulatory approval of our investigational medicines;
|
•
|
our ability to commercialize our products, if approved;
|
•
|
the pricing and reimbursement of our investigational medicines, if approved;
|
•
|
the implementation of our business model, and strategic plans for our business, investigational medicines, and technology;
|
•
|
the scope of protection we are able to establish and maintain for intellectual property rights covering our investigational medicines and technology;
|
•
|
estimates of our future expenses, revenues, capital requirements, and our needs for additional financing;
|
•
|
the potential benefits of strategic collaboration agreements, our ability to enter into strategic collaborations or arrangements, and our ability to attract collaborators with development, regulatory, and commercialization expertise;
|
•
|
future agreements with third parties in connection with the commercialization of our investigational medicines, if approved;
|
•
|
the size and growth potential of the markets for our investigational medicines, and our ability to serve those markets;
|
•
|
our financial performance;
|
•
|
the rate and degree of market acceptance of our investigational medicines;
|
•
|
regulatory developments in the United States and foreign countries;
|
•
|
our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately;
|
•
|
our ability to produce our products or investigational medicines with advantages in turnaround times or manufacturing cost;
|
•
|
the success of competing therapies that are or may become available;
|
•
|
our ability to attract and retain key scientific or management personnel;
|
•
|
the impact of laws and regulations;
|
•
|
developments relating to our competitors and our industry; and
|
•
|
other risks and uncertainties, including those discussed in Part II, Item 1A - Risk Factors in this Form 10-Q.
|
PART I.
|
|
Page
|
Item 1.
|
||
|
||
|
||
|
||
|
||
|
||
|
||
Item 2.
|
||
Item 3.
|
||
Item 4.
|
||
PART II.
|
|
|
Item 1.
|
||
Item 1A.
|
||
Item 2
|
||
Item 6.
|
||
|
|
|
September 30,
|
|
December 31,
|
||||
|
2019
|
|
2018
|
||||
Assets
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
173,711
|
|
|
$
|
658,364
|
|
Investments
|
884,829
|
|
|
863,063
|
|
||
Accounts receivable
|
2,800
|
|
|
11,686
|
|
||
Accounts receivable from related party
|
5,416
|
|
|
899
|
|
||
Prepaid expenses and other current assets
|
26,678
|
|
|
28,399
|
|
||
Restricted cash
|
1,032
|
|
|
595
|
|
||
Total current assets
|
1,094,466
|
|
|
1,563,006
|
|
||
Investments, non-current
|
279,860
|
|
|
172,990
|
|
||
Property and equipment, net
|
203,688
|
|
|
211,977
|
|
||
Restricted cash, non-current
|
10,791
|
|
|
11,532
|
|
||
Other non-current assets
|
2,094
|
|
|
2,644
|
|
||
Total assets
|
$
|
1,590,899
|
|
|
$
|
1,962,149
|
|
Liabilities and Stockholders’ Equity
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
11,737
|
|
|
$
|
31,210
|
|
Accrued liabilities
|
60,079
|
|
|
79,073
|
|
||
Deferred revenue
|
70,191
|
|
|
109,056
|
|
||
Other current liabilities
|
5,835
|
|
|
3,464
|
|
||
Total current liabilities
|
147,842
|
|
|
222,803
|
|
||
Deferred revenue, non-current
|
143,438
|
|
|
165,352
|
|
||
Deferred lease obligation, non-current
|
13,850
|
|
|
10,006
|
|
||
Lease financing obligation
|
33,801
|
|
|
33,489
|
|
||
Other non-current liabilities
|
161
|
|
|
258
|
|
||
Total liabilities
|
339,092
|
|
|
431,908
|
|
||
Commitments and contingencies (Note 7)
|
|
|
|
||||
Stockholders’ equity:
|
|
|
|
||||
Preferred stock, par value $0.0001; 162,000,000 shares authorized as of September 30, 2019
and December 31, 2018; no shares issued or outstanding at September 30, 2019 and
December 31, 2018
|
—
|
|
|
—
|
|
||
Common stock, par value $0.0001; 1,600,000,000 shares authorized as of September 30, 2019 and December 31, 2018; 332,494,777 and 328,798,904 shares issued and outstanding as of September 30, 2019 and December 31, 2018, respectively
|
33
|
|
|
33
|
|
||
Additional paid-in capital
|
2,618,492
|
|
|
2,538,155
|
|
||
Accumulated other comprehensive income (loss)
|
2,830
|
|
|
(1,320
|
)
|
||
Accumulated deficit
|
(1,369,548
|
)
|
|
(1,006,627
|
)
|
||
Total stockholders’ equity
|
1,251,807
|
|
|
1,530,241
|
|
||
Total liabilities and stockholders’ equity
|
$
|
1,590,899
|
|
|
$
|
1,962,149
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Revenue:
|
|
|
|
|
|
|
|
||||||||
Collaboration revenue
|
$
|
9,614
|
|
|
$
|
16,935
|
|
|
$
|
32,757
|
|
|
$
|
56,530
|
|
Collaboration revenue from related party
|
3,724
|
|
|
19,727
|
|
|
4,726
|
|
|
33,166
|
|
||||
Grant revenue
|
3,708
|
|
|
5,095
|
|
|
8,671
|
|
|
9,951
|
|
||||
Total revenue
|
17,046
|
|
|
41,757
|
|
|
46,154
|
|
|
99,647
|
|
||||
Operating expenses:
|
|
|
|
|
|
|
|
||||||||
Research and development
|
119,715
|
|
|
109,050
|
|
|
378,786
|
|
|
303,653
|
|
||||
General and administrative
|
28,188
|
|
|
18,525
|
|
|
83,994
|
|
|
56,229
|
|
||||
Total operating expenses
|
147,903
|
|
|
127,575
|
|
|
462,780
|
|
|
359,882
|
|
||||
Loss from operations
|
(130,857
|
)
|
|
(85,818
|
)
|
|
(416,626
|
)
|
|
(260,235
|
)
|
||||
Interest income
|
9,252
|
|
|
6,519
|
|
|
30,546
|
|
|
18,129
|
|
||||
Other expense, net
|
(1,767
|
)
|
|
(1,032
|
)
|
|
(5,351
|
)
|
|
(1,044
|
)
|
||||
Loss before income taxes
|
(123,372
|
)
|
|
(80,331
|
)
|
|
(391,431
|
)
|
|
(243,150
|
)
|
||||
(Benefit from) provision for income taxes
|
(178
|
)
|
|
—
|
|
|
(526
|
)
|
|
158
|
|
||||
Net loss
|
$
|
(123,194
|
)
|
|
$
|
(80,331
|
)
|
|
$
|
(390,905
|
)
|
|
$
|
(243,308
|
)
|
Net loss attributable to common stockholders (Note 11)
|
$
|
(123,194
|
)
|
|
$
|
(87,819
|
)
|
|
$
|
(390,905
|
)
|
|
$
|
(257,758
|
)
|
Net loss per share attributable to common stockholders, basic and diluted
|
$
|
(0.37
|
)
|
|
$
|
(1.32
|
)
|
|
$
|
(1.19
|
)
|
|
$
|
(3.91
|
)
|
Weighted average common shares used in net loss per share attributable to common stockholders, basic and diluted
|
330,769,341
|
|
|
66,283,040
|
|
|
329,592,322
|
|
|
65,887,511
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Net loss
|
$
|
(123,194
|
)
|
|
$
|
(80,331
|
)
|
|
$
|
(390,905
|
)
|
|
$
|
(243,308
|
)
|
Other comprehensive income (loss):
|
|
|
|
|
|
|
|
||||||||
Unrealized gain on available-for-sale debt securities, net of tax, $25 and $0, for three months ended September 30, 2019 and 2018, respectively, and net of tax, $1,173 and $0, for nine months ended September 30, 2019 and 2018, respectively
|
168
|
|
|
458
|
|
|
4,243
|
|
|
197
|
|
||||
Less: amounts recognized for net realized (gain)/loss included in net loss
|
(79
|
)
|
|
629
|
|
|
(93
|
)
|
|
38
|
|
||||
Total other comprehensive income
|
89
|
|
|
1,087
|
|
|
4,150
|
|
|
235
|
|
||||
Comprehensive loss
|
$
|
(123,105
|
)
|
|
$
|
(79,244
|
)
|
|
$
|
(386,755
|
)
|
|
$
|
(243,073
|
)
|
|
|
Three Months Ended September 30, 2019
|
||||||||||||||||||||||||||||||
|
|
Redeemable Convertible
Preferred Stock
|
|
|
|
Common Stock
|
|
Additional
Paid-In
Capital
|
|
Accumulated
Other
Comprehensive
Income
|
|
Accumulated
Deficit
|
|
Total
Stockholders’
Equity
|
||||||||||||||||||
|
|
Shares
|
|
Amount
|
|
|
|
Shares
|
|
Amount
|
|
|
|
|
||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Balance at June 30, 2019
|
|
—
|
|
|
$
|
—
|
|
|
|
|
329,958,172
|
|
|
$
|
33
|
|
|
$
|
2,582,134
|
|
|
$
|
2,741
|
|
|
$
|
(1,246,354
|
)
|
|
$
|
1,338,554
|
|
Vesting of restricted common stock
|
|
—
|
|
|
—
|
|
|
|
|
33,678
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Exercise of options to purchase common stock, net
|
|
—
|
|
|
—
|
|
|
|
|
2,502,927
|
|
|
—
|
|
|
15,554
|
|
|
—
|
|
|
—
|
|
|
15,554
|
|
||||||
Stock-based compensation
|
|
—
|
|
|
—
|
|
|
|
|
—
|
|
|
—
|
|
|
20,804
|
|
|
—
|
|
|
—
|
|
|
20,804
|
|
||||||
Unrealized gain on marketable securities
|
|
—
|
|
|
—
|
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
89
|
|
|
—
|
|
|
89
|
|
||||||
Net loss
|
|
—
|
|
|
—
|
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(123,194
|
)
|
|
(123,194
|
)
|
||||||
Balance at September 30, 2019
|
|
—
|
|
|
$
|
—
|
|
|
|
|
332,494,777
|
|
|
$
|
33
|
|
|
$
|
2,618,492
|
|
|
$
|
2,830
|
|
|
$
|
(1,369,548
|
)
|
|
$
|
1,251,807
|
|
|
|
Three Months Ended September 30, 2018
|
||||||||||||||||||||||||||||||
|
|
Redeemable Convertible
Preferred Stock
|
|
|
|
Common Stock
|
|
Additional
Paid-In
Capital
|
|
Accumulated
Other
Comprehensive
Loss
|
|
Accumulated
Deficit
|
|
Total
Stockholders’
Deficit
|
||||||||||||||||||
|
|
Shares
|
|
Amount
|
|
|
|
Shares
|
|
Amount
|
|
|
|
|
||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Balance at June 30, 2018
|
|
509,352,795
|
|
|
$
|
1,837,620
|
|
|
|
|
66,204,796
|
|
|
$
|
6
|
|
|
$
|
98,105
|
|
|
$
|
(2,009
|
)
|
|
$
|
(784,870
|
)
|
|
$
|
(688,768
|
)
|
Vesting of restricted common stock
|
|
—
|
|
|
—
|
|
|
|
|
103,798
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Exercise of options to purchase common stock, net
|
|
—
|
|
|
—
|
|
|
|
|
44,307
|
|
|
—
|
|
|
290
|
|
|
—
|
|
|
—
|
|
|
290
|
|
||||||
Repurchase of Series D redeemable convertible preferred stock
|
|
(269,180
|
)
|
|
(704
|
)
|
|
|
|
—
|
|
|
—
|
|
|
(2,009
|
)
|
|
—
|
|
|
—
|
|
|
(2,009
|
)
|
||||||
Repurchase of Series E redeemable convertible preferred stock
|
|
(544,100
|
)
|
|
(3,355
|
)
|
|
|
|
—
|
|
|
—
|
|
|
(2,118
|
)
|
|
—
|
|
|
—
|
|
|
(2,118
|
)
|
||||||
Stock-based compensation
|
|
—
|
|
|
—
|
|
|
|
|
—
|
|
|
—
|
|
|
14,720
|
|
|
—
|
|
|
—
|
|
|
14,720
|
|
||||||
Unrealized gain on marketable securities
|
|
—
|
|
|
—
|
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,087
|
|
|
—
|
|
|
1,087
|
|
||||||
Net loss
|
|
—
|
|
|
—
|
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(80,331
|
)
|
|
(80,331
|
)
|
||||||
Balance at September 30, 2018
|
|
508,539,515
|
|
|
$
|
1,833,561
|
|
|
|
|
66,352,901
|
|
|
$
|
6
|
|
|
$
|
108,988
|
|
|
$
|
(922
|
)
|
|
$
|
(865,201
|
)
|
|
$
|
(757,129
|
)
|
|
|
Nine Months Ended September 30, 2019
|
||||||||||||||||||||||||||||||
|
|
Redeemable Convertible
Preferred Stock
|
|
|
|
Common Stock
|
|
Additional
Paid-In
Capital
|
|
Accumulated
Other
Comprehensive
Income
|
|
Accumulated
Deficit
|
|
Total
Stockholders’
Equity
|
||||||||||||||||||
|
|
Shares
|
|
Amount
|
|
|
|
Shares
|
|
Amount
|
|
|
|
|
||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Balance at December 31, 2018
|
|
—
|
|
|
$
|
—
|
|
|
|
|
328,798,904
|
|
|
$
|
33
|
|
|
$
|
2,538,155
|
|
|
$
|
(1,320
|
)
|
|
$
|
(1,006,627
|
)
|
|
$
|
1,530,241
|
|
Transition adjustment from adoption of ASU Topic 606 (Note 2)
|
|
|
|
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
27,984
|
|
|
27,984
|
|
||||||||
Vesting of restricted common stock
|
|
—
|
|
|
—
|
|
|
|
|
141,153
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Exercise of options to purchase common stock, net
|
|
—
|
|
|
—
|
|
|
|
|
3,554,720
|
|
|
—
|
|
|
19,541
|
|
|
—
|
|
|
—
|
|
|
19,541
|
|
||||||
Stock-based compensation
|
|
—
|
|
|
—
|
|
|
|
|
—
|
|
|
—
|
|
|
60,796
|
|
|
—
|
|
|
—
|
|
|
60,796
|
|
||||||
Unrealized gain on marketable securities
|
|
—
|
|
|
—
|
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4,150
|
|
|
—
|
|
|
4,150
|
|
||||||
Net loss
|
|
—
|
|
|
—
|
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(390,905
|
)
|
|
(390,905
|
)
|
||||||
Balance at September 30, 2019
|
|
—
|
|
|
$
|
—
|
|
|
|
|
332,494,777
|
|
|
$
|
33
|
|
|
$
|
2,618,492
|
|
|
$
|
2,830
|
|
|
$
|
(1,369,548
|
)
|
|
$
|
1,251,807
|
|
|
|
Nine Months Ended September 30, 2018
|
||||||||||||||||||||||||||||||
|
|
Redeemable Convertible
Preferred Stock
|
|
|
|
Common Stock
|
|
Additional
Paid-In
Capital
|
|
Accumulated
Other
Comprehensive
Loss
|
|
Accumulated
Deficit
|
|
Total
Stockholders’
Deficit
|
||||||||||||||||||
|
|
Shares
|
|
Amount
|
|
|
|
Shares
|
|
Amount
|
|
|
|
|
||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Balance at December 31, 2017
|
|
448,686,791
|
|
|
$
|
1,176,661
|
|
|
|
|
65,206,999
|
|
|
$
|
6
|
|
|
$
|
71,679
|
|
|
$
|
(1,157
|
)
|
|
$
|
(621,893
|
)
|
|
$
|
(551,365
|
)
|
Vesting of restricted common stock
|
|
—
|
|
|
—
|
|
|
|
|
754,127
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Issuance of Series G redeemable convertible preferred stock, net of issuance costs of $10,517
|
|
55,666,004
|
|
|
549,413
|
|
|
|
|
—
|
|
|
—
|
|
|
152
|
|
|
—
|
|
|
—
|
|
|
152
|
|
||||||
Issuance of Series H redeemable convertible preferred stock, net of issuance costs of $474
|
|
5,000,000
|
|
|
111,546
|
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Repurchase of Series D redeemable convertible preferred stock
|
|
(269,180
|
)
|
|
(704
|
)
|
|
|
|
—
|
|
|
—
|
|
|
(2,009
|
)
|
|
—
|
|
|
—
|
|
|
(2,009
|
)
|
||||||
Repurchase of Series E redeemable convertible preferred stock
|
|
(544,100
|
)
|
|
(3,355
|
)
|
|
|
|
—
|
|
|
—
|
|
|
(2,118
|
)
|
|
—
|
|
|
—
|
|
|
(2,118
|
)
|
||||||
Exercise of options to purchase common stock, net
|
|
—
|
|
|
—
|
|
|
|
|
391,775
|
|
|
—
|
|
|
360
|
|
|
—
|
|
|
—
|
|
|
360
|
|
||||||
Stock-based compensation
|
|
—
|
|
|
—
|
|
|
|
|
—
|
|
|
—
|
|
|
40,924
|
|
|
—
|
|
|
—
|
|
|
40,924
|
|
||||||
Unrealized loss on marketable securities
|
|
—
|
|
|
—
|
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
235
|
|
|
—
|
|
|
235
|
|
||||||
Net loss
|
|
—
|
|
|
—
|
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(243,308
|
)
|
|
(243,308
|
)
|
||||||
Balance at September 30, 2018
|
|
508,539,515
|
|
|
$
|
1,833,561
|
|
|
|
|
66,352,901
|
|
|
$
|
6
|
|
|
$
|
108,988
|
|
|
$
|
(922
|
)
|
|
$
|
(865,201
|
)
|
|
$
|
(757,129
|
)
|
|
Nine Months Ended September 30,
|
||||||
|
2019
|
|
2018
|
||||
Operating activities
|
|
|
|
||||
Net loss
|
$
|
(390,905
|
)
|
|
$
|
(243,308
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
Stock-based compensation
|
60,796
|
|
|
40,924
|
|
||
Depreciation and amortization
|
22,082
|
|
|
17,512
|
|
||
Amortization/accretion of investments
|
(3,428
|
)
|
|
(1,103
|
)
|
||
Loss on disposal of property and equipment
|
70
|
|
|
—
|
|
||
Changes in assets and liabilities:
|
|
|
|
||||
Accounts receivable
|
8,886
|
|
|
2,036
|
|
||
Accounts receivable from related party
|
(4,517
|
)
|
|
(176
|
)
|
||
Prepaid expenses and other assets
|
(1,407
|
)
|
|
(5,246
|
)
|
||
Accounts payable
|
(19,185
|
)
|
|
718
|
|
||
Accrued liabilities
|
(8,253
|
)
|
|
(17,190
|
)
|
||
Deferred revenue
|
(32,795
|
)
|
|
(37,103
|
)
|
||
Deferred lease obligation
|
3,844
|
|
|
2,237
|
|
||
Other liabilities
|
1,617
|
|
|
854
|
|
||
Net cash used in operating activities
|
(363,195
|
)
|
|
(239,845
|
)
|
||
Investing activities
|
|
|
|
||||
Purchases of marketable securities
|
(949,277
|
)
|
|
(951,194
|
)
|
||
Proceeds from maturities of marketable securities
|
747,846
|
|
|
493,525
|
|
||
Proceeds from sales of marketable securities
|
81,030
|
|
|
170,531
|
|
||
Purchases of property and equipment
|
(24,892
|
)
|
|
(92,129
|
)
|
||
Net cash used in investing activities
|
(145,293
|
)
|
|
(379,267
|
)
|
||
Financing activities
|
|
|
|
||||
Proceeds from issuance of redeemable convertible preferred stock, net of issuance costs
|
—
|
|
|
661,111
|
|
||
Repurchases of redeemable convertible preferred stock
|
—
|
|
|
(8,182
|
)
|
||
Proceeds from issuance of common stock through equity plans, net
|
19,541
|
|
|
360
|
|
||
Reimbursement of assets under lease financing obligation
|
3,678
|
|
|
1,747
|
|
||
Payments on financing lease obligation
|
312
|
|
|
(4,109
|
)
|
||
Net cash provided by financing activities
|
23,531
|
|
|
650,927
|
|
||
Net (decrease) increase in cash, cash equivalents and restricted cash
|
(484,957
|
)
|
|
31,815
|
|
||
Cash, cash equivalents and restricted cash, beginning of year
|
670,491
|
|
|
147,608
|
|
||
Cash, cash equivalents and restricted cash, end of period
|
$
|
185,534
|
|
|
$
|
179,423
|
|
Non-cash investing and financing activities
|
|
|
|
||||
Purchases of property and equipment included in accounts payable and accrued liabilities
|
$
|
1,863
|
|
|
$
|
12,768
|
|
Leasehold improvements included in prepaid and other current assets
|
$
|
6,310
|
|
|
$
|
13,567
|
|
Lease financing obligation
|
$
|
—
|
|
|
$
|
13,567
|
|
|
Unrealized Gain on Available-for-Sale Debt Securities
|
||
|
September 30, 2019
|
||
Accumulated other comprehensive loss, balance at December 31, 2018
|
$
|
(1,320
|
)
|
Other comprehensive income
|
1,911
|
|
|
Accumulated other comprehensive income, balance at March 31, 2019
|
591
|
|
|
Other comprehensive income
|
2,150
|
|
|
Accumulated other comprehensive income, balance at June 30, 2019
|
2,741
|
|
|
Other comprehensive income
|
89
|
|
|
Accumulated other comprehensive income, balance at September 30, 2019
|
$
|
2,830
|
|
Condensed Consolidated Balance Sheet
|
|
Balance at December 31, 2018
|
|
Adjustments
|
|
Balance at
January 1, 2019
|
||||||
Deferred revenue, current
|
|
$
|
109,056
|
|
|
$
|
(27,281
|
)
|
|
$
|
81,775
|
|
Deferred revenue, non-current
|
|
165,352
|
|
|
(3,441
|
)
|
|
161,911
|
|
|||
Accounts receivable
|
|
11,686
|
|
|
(2,738
|
)
|
|
8,948
|
|
|||
Accumulated deficit
|
|
(1,006,627
|
)
|
|
27,984
|
|
|
(978,643
|
)
|
|
|
September 30, 2019
|
||||||||||
Condensed Consolidated Balance Sheet
|
|
As reported under ASC 606
|
|
Adjustments
|
|
Balance without adoption of ASC 606
|
||||||
Deferred revenue, current
|
|
$
|
70,191
|
|
|
$
|
(16,549
|
)
|
|
$
|
53,642
|
|
Deferred revenue, non-current
|
|
143,438
|
|
|
11,259
|
|
|
154,697
|
|
|||
Accumulated deficit
|
|
(1,369,548
|
)
|
|
6,081
|
|
|
(1,363,467
|
)
|
|
|
Three Months Ended September 30, 2019
|
||||||||||
Condensed Consolidated Statement of Operations
|
|
As reported under ASC 606
|
|
Adjustments
|
|
Amount without adoption of ASC 606
|
||||||
Revenue:
|
|
|
|
|
|
|
||||||
Collaboration revenue
|
|
$
|
9,614
|
|
|
$
|
676
|
|
|
$
|
10,290
|
|
Collaboration revenue from related party
|
|
3,724
|
|
|
7,000
|
|
|
10,724
|
|
|||
Total revenue
|
|
17,046
|
|
|
7,676
|
|
|
24,722
|
|
|||
Loss from operations
|
|
(130,857
|
)
|
|
7,676
|
|
|
(123,181
|
)
|
|||
Loss before income taxes
|
|
(123,372
|
)
|
|
7,676
|
|
|
(115,696
|
)
|
|||
Net loss
|
|
(123,194
|
)
|
|
7,676
|
|
|
(115,518
|
)
|
|||
Net loss per share - basic and diluted
|
|
(0.37
|
)
|
|
0.02
|
|
|
(0.35
|
)
|
|
|
Nine Months Ended September 30, 2019
|
||||||||||
Condensed Consolidated Statement of Operations
|
|
As reported under ASC 606
|
|
Adjustments
|
|
Amount without adoption of ASC 606
|
||||||
Revenue:
|
|
|
|
|
|
|
||||||
Collaboration revenue
|
|
$
|
32,757
|
|
|
$
|
2,045
|
|
|
$
|
34,802
|
|
Collaboration revenue from related party
|
|
4,726
|
|
|
32,019
|
|
|
36,745
|
|
|||
Total revenue
|
|
46,154
|
|
|
34,064
|
|
|
80,218
|
|
|||
Loss from operations
|
|
(416,626
|
)
|
|
34,064
|
|
|
(382,562
|
)
|
|||
Loss before income taxes
|
|
(391,431
|
)
|
|
34,064
|
|
|
(357,367
|
)
|
|||
Net loss
|
|
(390,905
|
)
|
|
34,064
|
|
|
(356,841
|
)
|
|||
Net loss per share - basic and diluted
|
|
(1.19
|
)
|
|
0.11
|
|
|
(1.08
|
)
|
|
|
As of September 30,
|
||||||
|
|
2019
|
|
2018
|
||||
Cash and cash equivalents
|
|
$
|
173,711
|
|
|
$
|
167,060
|
|
Restricted cash
|
|
1,032
|
|
|
831
|
|
||
Restricted cash, non-current
|
|
10,791
|
|
|
11,532
|
|
||
Total cash, cash equivalents and restricted cash shown in the condensed consolidated
statements of cash flows
|
|
$
|
185,534
|
|
|
$
|
179,423
|
|
|
|
Three Months Ended
|
||||||||||
Collaboration Revenue by Strategic Collaborator:
|
|
September 30, 2019
as reported (under ASU 606) |
|
September 30, 2019
without adoption of 606 (under ASC 605) |
|
September 30, 2018
as reported (under ASC 605) |
||||||
Merck
|
|
$
|
9,110
|
|
|
$
|
9,786
|
|
|
$
|
14,475
|
|
AstraZeneca
|
|
3,724
|
|
|
10,724
|
|
|
19,727
|
|
|||
Vertex
|
|
504
|
|
|
504
|
|
|
2,460
|
|
|||
Total collaboration revenue
|
|
$
|
13,338
|
|
|
$
|
21,014
|
|
|
$
|
36,662
|
|
|
|
Nine Months Ended
|
||||||||||
Collaboration Revenue by Strategic Collaborator:
|
|
September 30, 2019
as reported (under ASU 606) |
|
September 30, 2019
without adoption of 606 (under ASC 605) |
|
September 30, 2018
as reported (under ASC 605) |
||||||
Merck
|
|
$
|
28,456
|
|
|
$
|
30,103
|
|
|
$
|
47,537
|
|
AstraZeneca
|
|
4,726
|
|
|
36,745
|
|
|
33,166
|
|
|||
Vertex
|
|
4,301
|
|
|
4,699
|
|
|
8,993
|
|
|||
Total collaboration revenue
|
|
$
|
37,483
|
|
|
$
|
71,547
|
|
|
$
|
89,696
|
|
|
|
January 1, 2019
|
|
Additions
|
|
Deductions
|
|
September 30, 2019
|
||||||||
Contract Assets:
|
|
|
|
|
|
|
|
|
||||||||
Accounts receivable
|
|
$
|
4,612
|
|
|
$
|
12,118
|
|
|
$
|
(8,514
|
)
|
|
$
|
8,216
|
|
Contract Liabilities:
|
|
|
|
|
|
|
|
|
||||||||
Deferred revenue
|
|
$
|
240,924
|
|
|
$
|
9,774
|
|
|
$
|
(40,245
|
)
|
|
$
|
210,453
|
|
Revenue recognized in the period from:
|
|
Three Months Ended September 30, 2019
|
|
Nine Months Ended September 30, 2019
|
||||
Amounts included in contract liabilities at the beginning of the period (1)
|
|
$
|
15,080
|
|
|
$
|
40,245
|
|
|
|
September 30, 2019
|
||||||||||||||||||||||||||
|
|
Amortized
Cost
|
|
Unrealized
Gains
|
|
Unrealized
Losses
|
|
Fair Value
|
|
Cash and
Cash
Equivalents
|
|
Current
Marketable
Securities
|
|
Non-
Current
Marketable
Securities
|
||||||||||||||
Cash and cash equivalents
|
|
$
|
173,711
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
173,711
|
|
|
$
|
173,711
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Available-for-sale:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Level 2:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Certificates of deposit
|
|
81,350
|
|
|
147
|
|
|
—
|
|
|
81,497
|
|
|
—
|
|
|
81,497
|
|
|
—
|
|
|||||||
U.S. treasury securities
|
|
146,825
|
|
|
421
|
|
|
—
|
|
|
147,246
|
|
|
—
|
|
|
124,355
|
|
|
22,891
|
|
|||||||
Debt securities of U.S. government agencies and corporate entities
|
|
932,510
|
|
|
3,457
|
|
|
(21
|
)
|
|
935,946
|
|
|
—
|
|
|
678,977
|
|
|
256,969
|
|
|||||||
|
|
$
|
1,334,396
|
|
|
$
|
4,025
|
|
|
$
|
(21
|
)
|
|
$
|
1,338,400
|
|
|
$
|
173,711
|
|
|
$
|
884,829
|
|
|
$
|
279,860
|
|
|
|
December 31, 2018
|
||||||||||||||||||||||||||
|
|
Amortized
Cost
|
|
Unrealized
Gains
|
|
Unrealized
Losses
|
|
Fair Value
|
|
Cash and
Cash
Equivalents
|
|
Current
Marketable
Securities
|
|
Non-
Current
Marketable
Securities
|
||||||||||||||
Cash and cash equivalents
|
|
$
|
658,365
|
|
|
$
|
20
|
|
|
$
|
(21
|
)
|
|
$
|
658,364
|
|
|
$
|
658,364
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Available-for-sale:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Level 2:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Certificates of deposit
|
|
173,102
|
|
|
42
|
|
|
(36
|
)
|
|
173,108
|
|
|
—
|
|
|
157,920
|
|
|
15,188
|
|
|||||||
U.S. treasury securities
|
|
152,205
|
|
|
18
|
|
|
(48
|
)
|
|
152,175
|
|
|
—
|
|
|
152,175
|
|
|
—
|
|
|||||||
Debt securities of U.S. government agencies and corporate entities
|
|
712,065
|
|
|
40
|
|
|
(1,335
|
)
|
|
710,770
|
|
|
—
|
|
|
552,968
|
|
|
157,802
|
|
|||||||
|
|
$
|
1,695,737
|
|
|
$
|
120
|
|
|
$
|
(1,440
|
)
|
|
$
|
1,694,417
|
|
|
$
|
658,364
|
|
|
$
|
863,063
|
|
|
$
|
172,990
|
|
|
|
September 30, 2019
|
||||||
|
|
Amortized
Cost
|
|
Estimated
Fair Value
|
||||
Due in one year or less
|
|
$
|
882,514
|
|
|
$
|
884,829
|
|
Due after one year through five years
|
|
278,171
|
|
|
279,860
|
|
||
Total
|
|
$
|
1,160,685
|
|
|
$
|
1,164,689
|
|
|
|
September 30,
|
|
December 31,
|
||||
|
|
2019
|
|
2018
|
||||
Prepaid expenses
|
|
$
|
9,730
|
|
|
$
|
10,401
|
|
Tenant incentives receivables
|
|
9,904
|
|
|
10,089
|
|
||
Interest receivable on marketable securities
|
|
7,044
|
|
|
7,909
|
|
||
Prepaid expenses and other current assets
|
|
$
|
26,678
|
|
|
$
|
28,399
|
|
|
|
September 30,
|
|
December 31,
|
||||
|
|
2019
|
|
2018
|
||||
Building
|
|
$
|
144,039
|
|
|
$
|
140,442
|
|
Laboratory equipment
|
|
103,854
|
|
|
96,907
|
|
||
Leasehold improvements
|
|
15,124
|
|
|
13,741
|
|
||
Furniture, fixtures and other
|
|
2,142
|
|
|
2,122
|
|
||
Computer equipment and software
|
|
11,918
|
|
|
11,513
|
|
||
Internally developed software
|
|
7,020
|
|
|
7,020
|
|
||
Construction in progress
|
|
5,992
|
|
|
4,688
|
|
||
|
|
290,089
|
|
|
276,433
|
|
||
Less: Accumulated depreciation
|
|
(86,401
|
)
|
|
(64,456
|
)
|
||
Property and equipment, net
|
|
$
|
203,688
|
|
|
$
|
211,977
|
|
|
|
September 30,
|
|
December 31,
|
||||
|
|
2019
|
|
2018
|
||||
In-licenses
|
|
$
|
—
|
|
|
$
|
22,000
|
|
Property and equipment
|
|
2,275
|
|
|
12,089
|
|
||
Compensation-related
|
|
23,963
|
|
|
23,406
|
|
||
External goods and services
|
|
33,841
|
|
|
21,578
|
|
||
Accrued liabilities
|
|
$
|
60,079
|
|
|
$
|
79,073
|
|
Fiscal Year
|
Minimum Lease Payments
|
|||
2019
|
(remainder of the year)
|
$
|
5,440
|
|
2020
|
|
19,972
|
|
|
2021
|
|
19,886
|
|
|
2022
|
|
20,347
|
|
|
2023
|
|
20,583
|
|
|
Thereafter
|
161,218
|
|
||
Total
|
$
|
247,446
|
|
|
|
Number of
Options
|
|
Weighted-
Average
Exercise
Price per
Share
|
|
Weighted-
Average
Grant
Date Fair
Value per
Share
|
|
Weighted-
Average
Remaining
Contractual
Term
|
|
Aggregate
Intrinsic
Value (1)
(in thousands)
|
|||||||
Outstanding at December 31, 2018
|
|
50,821,132
|
|
|
$
|
12.16
|
|
|
$
|
6.59
|
|
|
7.1 years
|
|
$
|
220,434
|
|
Granted
|
|
6,543,166
|
|
|
20.01
|
|
|
11.71
|
|
|
|
|
|
||||
Exercised
|
|
(3,554,720
|
)
|
|
5.61
|
|
|
3.89
|
|
|
|
|
|
||||
Canceled/forfeited
|
|
(4,846,923
|
)
|
|
14.94
|
|
|
8.65
|
|
|
|
|
|
||||
Outstanding at September 30, 2019
|
|
48,962,655
|
|
|
13.43
|
|
|
7.18
|
|
|
7.2 years
|
|
201,014
|
|
|||
Exercisable at September 30, 2019
|
|
24,449,929
|
|
|
9.64
|
|
|
4.58
|
|
|
5.6 years
|
|
167,915
|
|
|||
Expected to vest at September 30, 2019
|
|
24,512,726
|
|
|
17.22
|
|
|
9.78
|
|
|
8.7 years
|
|
33,099
|
|
|
Number of
Shares |
|
Weighted
Average
Fair Value
per Share
|
|||
Outstanding, non-vested at December 31, 2018
|
198,597
|
|
|
$
|
12.15
|
|
Issued
|
—
|
|
|
—
|
|
|
Vested
|
(141,153
|
)
|
|
12.15
|
|
|
Canceled, forfeited and adjustments, net
|
(35,880
|
)
|
|
12.15
|
|
|
Outstanding, non-vested at September 30, 2019
|
21,564
|
|
|
12.15
|
|
|
Units
|
|
Weighted-Average
Fair Value
per Unit
|
|||
Outstanding, non-vested at December 31, 2018
|
458,715
|
|
|
$
|
11.93
|
|
Issued
|
1,247,620
|
|
|
19.19
|
|
|
Vested (1)
|
43,002
|
|
|
11.93
|
|
|
Canceled/forfeited
|
(47,148
|
)
|
|
21.01
|
|
|
Pending settlement (1)
|
(43,002
|
)
|
|
11.93
|
|
|
Outstanding, non-vested at September 30, 2019
|
1,659,187
|
|
|
17.13
|
|
|
|
Weighted Average
|
||||||
|
|
Nine Months Ended September 30,
|
||||||
|
|
2019
|
|
2018
|
||||
Options:
|
|
|
|
|
||||
Risk-free interest rate
|
|
2.39
|
%
|
|
2.71
|
%
|
||
Expected term
|
|
6.07 years
|
|
|
6.06 years
|
|
||
Expected volatility
|
|
62
|
%
|
|
64
|
%
|
||
Expected dividends
|
|
—
|
%
|
|
—
|
%
|
||
Weighted average fair value per share
|
|
$
|
11.71
|
|
|
$
|
8.68
|
|
|
|
|
|
|
||||
ESPP:
|
|
|
|
|
||||
Risk-free interest rate
|
|
2.31
|
%
|
|
|
|||
Expected term
|
|
0.50 years
|
|
|
|
|||
Expected volatility
|
|
50
|
%
|
|
|
|||
Expected dividends
|
|
—
|
%
|
|
|
|||
Weighted average fair value per share
|
|
19.85
|
|
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, 2019 |
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Options
|
$
|
18,994
|
|
|
$
|
13,917
|
|
|
$
|
56,475
|
|
|
$
|
37,228
|
|
Restricted common stock and units
|
1,291
|
|
|
803
|
|
|
3,628
|
|
|
3,696
|
|
||||
ESPP
|
519
|
|
|
—
|
|
|
693
|
|
|
—
|
|
||||
Total
|
$
|
20,804
|
|
|
$
|
14,720
|
|
|
$
|
60,796
|
|
|
$
|
40,924
|
|
Research and development
|
$
|
12,616
|
|
|
$
|
8,714
|
|
|
$
|
36,268
|
|
|
$
|
24,498
|
|
General and administrative
|
8,188
|
|
|
6,006
|
|
|
24,528
|
|
|
16,426
|
|
||||
Total
|
$
|
20,804
|
|
|
$
|
14,720
|
|
|
$
|
60,796
|
|
|
$
|
40,924
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Numerator:
|
|
|
|
|
|
|
|
||||||||
Net loss
|
$
|
(123,194
|
)
|
|
$
|
(80,331
|
)
|
|
$
|
(390,905
|
)
|
|
$
|
(243,308
|
)
|
Premium paid on repurchase of redeemable convertible preferred stock
|
—
|
|
|
(4,127
|
)
|
|
—
|
|
|
(4,127
|
)
|
||||
Cumulative dividends on redeemable convertible preferred stock
|
—
|
|
|
(3,361
|
)
|
|
—
|
|
|
(10,323
|
)
|
||||
Net loss attributable to common stockholders
|
$
|
(123,194
|
)
|
|
$
|
(87,819
|
)
|
|
$
|
(390,905
|
)
|
|
$
|
(257,758
|
)
|
Denominator:
|
|
|
|
|
|
|
|
||||||||
Weighted average common shares used in net loss per share attributable to common stockholders, basic and diluted
|
330,769,341
|
|
|
66,283,040
|
|
|
329,592,322
|
|
|
65,887,511
|
|
||||
Net loss per share attributable to common stockholders, basic and diluted
|
$
|
(0.37
|
)
|
|
$
|
(1.32
|
)
|
|
$
|
(1.19
|
)
|
|
$
|
(3.91
|
)
|
|
September 30,
|
||||
|
2019
|
|
2018
|
||
Redeemable convertible preferred stock
|
—
|
|
|
236,012,913
|
|
Stock options
|
48,962,655
|
|
|
44,075,419
|
|
Restricted common stock
|
21,564
|
|
|
306,281
|
|
Restricted common stock units
|
1,659,187
|
|
|
458,715
|
|
|
50,643,406
|
|
|
280,853,328
|
|
•
|
continue our platform research and drug discovery and development efforts;
|
•
|
conduct clinical studies for our investigational medicines;
|
•
|
manufacture clinical study materials and develop large-scale manufacturing capabilities;
|
•
|
seek regulatory approval for our investigational medicines;
|
•
|
maintain, expand, and protect our intellectual property;
|
•
|
hire additional personnel to support our program development effort to obtain regulatory approval and secure additional facilities for operations; and
|
•
|
continue to operate as a public company.
|
•
|
Prophylactic vaccines included eight development candidates across seven programs: RSV vaccine (mRNA-1777 and mRNA-1172 or V172), CMV vaccine (mRNA-1647), hMPV+PIV3 vaccine (mRNA-1653), H10N8 vaccine (mRNA-1440), H7N9 vaccine (mRNA-1851), Zika vaccine (mRNA-1893), and Chikungunya vaccine (mRNA-1388). All seven programs in this modality either have ongoing or completed Phase 1 clinical trials.
|
•
|
Cancer vaccines included two development candidates: Personalized cancer vaccine ("PCV") (mRNA-4157) and KRAS vaccine (mRNA-5671 or V941). We are collaborating with Merck on both programs. PCV is in a Phase 1 clinical trial and the first patient has been dosed in a Phase 2 clinical trial, and the KRAS vaccine is in a Phase 1 clinical trial.
|
•
|
Intratumoral immuno-oncology included three development candidates: OX40L (mRNA-2416), OX40L+IL23+IL36γ (Triplet) (mRNA-2752), and IL12 (MEDI1191). OX40L is currently being evaluated in a Phase 1/2 trial that includes a Phase 2 expansion cohort in patients with advanced ovarian carcinoma. Triplet and IL12 are currently in Phase 1 clinical trials.
|
•
|
Localized regenerative therapeutics included one development candidate, VEGF-A (AZD8601). The program is being led by AstraZeneca through clinical development and is in a Phase 2a clinical trial.
|
•
|
Systemic secreted therapeutics included three development candidates: antibody against Chikungunya virus (mRNA-1944), Relaxin (AZD7970), and Fabry disease (mRNA-3630). The antibody against Chikungunya virus development candidate is in collaboration with DARPA and the program is in a Phase 1 clinical trial. The Relaxin program in collaboration with AstraZeneca and the Fabry disease program are both in preclinical development.
|
•
|
Systemic intracellular therapeutics included four development candidates: MMA (mRNA-3704), PA (mRNA-3927), PKU (mRNA-3283), and GSD1a (mRNA-3745). The MMA program has open clinical sites for a Phase 1/2 clinical trial, the U.S. Food and Drug Administration (the "FDA") has completed its review of the IND for mRNA-3927 allowing the PA program to proceed to a Phase 1/2 clinical trial, and the PKU and GSD1a programs are in preclinical development.
|
•
|
CMV vaccine (mRNA-1647): We announced positive data from the three-month interim analysis of the Phase 1 clinical trial of mRNA-1647, which has completed enrollment and is evaluating the safety and immunogenicity of mRNA-1647 in healthy adult volunteers. The clinical trial population includes those who were naïve to CMV infection (CMV-seronegative) and those who had previously been infected by CMV (CMV-seropositive). Participants were randomized to receive either placebo, or 30, 90, 180 or 300 µg of mRNA-1647 on a dosing schedule of 0, 2 and 6 months. This first planned interim analysis assessed safety and immunogenicity of the first three dose levels (30, 90, and 180 µg) at three months, one month after the second vaccination and before the third vaccination. Neutralizing antibody titers (levels of circulating antibodies that block infection) were assessed in two assays utilizing epithelial cells and fibroblasts, which measure immune response to the pentamer and gB vaccine antigens, respectively. Seropositive baseline titers are associated with lower rates of congenital CMV transmission.
|
◦
|
A dose-related increase in neutralizing antibody titers was observed in both epithelial cell and fibroblast assays.
|
◦
|
In epithelial cells, after the second vaccination, neutralizing antibody titers were three to five times higher than CMV-seropositive baseline titers at the 90 and 180 µg dose levels.
|
◦
|
In fibroblasts, after the second vaccination, neutralizing antibody titers were equivalent to CMV-seropositive baseline titers at the 90 and 180 µg dose levels.
|
◦
|
For the 12 sentinel participants who received mRNA-1647 under an earlier arm of the protocol (Phase A) and who received three doses (at 0, 2 and 6 months), neutralizing antibody titers were further boosted at seven months and were sustained at or above CMV-seropositive baseline levels for at least 12 months.
|
◦
|
A dose-related increase in neutralizing antibody titers was observed in both epithelial cell and fibroblast assays.
|
◦
|
In epithelial cells, the second vaccination boosted neutralizing antibody titers to a level of 10-fold to 19-fold baseline titers in all dose groups.
|
◦
|
In fibroblasts, the second vaccination boosted neutralizing antibody titers to a level of 2-fold to 4-fold baseline titers in all dose groups.
|
•
|
hMPV+PIV3 vaccine (mRNA-1653): The first subject in the Phase 1b age de-escalation clinical trial of mRNA-1653 has been dosed.
|
•
|
Zika virus vaccine (mRNA-1893): The first subject has been dosed in the Phase 1 clinical trial of mRNA-1893, which recently received Fast Track designation from the FDA. This development candidate is being developed in collaboration with the U.S. Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
|
•
|
Personalized cancer vaccine (PCV) (mRNA-4157): The first patients have been dosed in the randomized Phase 2 clinical trial investigating a 1 mg dose of mRNA-4157 in combination with Merck’s pembrolizumab (KEYTRUDA), compared to pembrolizumab alone, for the adjuvant treatment of high-risk resected melanoma.
|
•
|
OX40L (mRNA-2416): Based on available data, we have decided to focus the development of mRNA-2416 for the treatment of patients with ovarian cancer in combination with durvalumab (IMFINZI), a PD-L1 inhibitor. The safety cohort of the combination arm (mRNA-2416 and durvalumab) of this Phase 1/2 clinical trial continues to enroll and will be followed by a Phase 2 expansion cohort in patients with advanced ovarian carcinoma. We will not move forward with the mRNA-2416 monotherapy ovarian cancer arm of this study.
|
•
|
Antibody against Chikungunya virus (mRNA-1944): We announced positive interim data in the first analysis of safety and activity in a Phase 1 clinical trial evaluating escalating doses of mRNA-1944 administered via intravenous infusion in healthy adults. mRNA-1944 encodes for an antibody (CHKV-24) with activity against chikungunya virus. At all three dose levels, the administration of mRNA-1944 led to detectable levels of CHKV-24 antibody in all participants, ranging from 1 µg/mL to 14 µg/mL. These results mark the first systemic mRNA therapeutic to show production of a secreted protein in humans.
|
•
|
Propionic Acidemia (PA) (mRNA-3927): FDA granted Fast Track designation for mRNA-3927. Study start-up is ongoing for the open-label, multi-center, dose escalation Phase 1/2 clinical trial of multiple ascending doses of mRNA-3927 in pediatric patients with PA in the U.S.
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Collaboration revenue:
|
|
|
|
|
|
|
|
||||||||
Merck
|
$
|
9,110
|
|
|
$
|
14,475
|
|
|
$
|
28,456
|
|
|
$
|
47,537
|
|
AstraZeneca
|
3,724
|
|
|
19,727
|
|
|
4,726
|
|
|
33,166
|
|
||||
Vertex
|
504
|
|
|
2,460
|
|
|
4,301
|
|
|
8,993
|
|
||||
Total collaboration revenue
|
$
|
13,338
|
|
|
$
|
36,662
|
|
|
$
|
37,483
|
|
|
$
|
89,696
|
|
•
|
cost to develop our platform;
|
•
|
discovery efforts leading to development candidates;
|
•
|
preclinical, nonclinical, and clinical development costs for our programs;
|
•
|
cost to develop our manufacturing technology and infrastructure; and
|
•
|
digital infrastructure costs.
|
•
|
personnel-related expenses, including salaries, benefits, and stock-based compensation expense;
|
•
|
expenses incurred under agreements with third parties, such as consultants, investigative sites, contract research organizations, or CROs, that conduct our preclinical and clinical studies, and in-licensing arrangements;
|
•
|
costs of acquiring, developing, and manufacturing materials for preclinical and clinical studies, including both internal manufacturing and third-party contract manufacturing organizations, or CMOs;
|
•
|
expenses incurred for the procurement of materials, laboratory supplies, and non-capital equipment used in the research and development process; and
|
•
|
facilities, depreciation, and amortization, and other direct and allocated expenses incurred as a result of research and development activities.
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Program expenses by modality:
|
|
|
|
|
|
|
|
||||||||
Prophylactic vaccines
|
$
|
5,666
|
|
|
$
|
4,499
|
|
|
$
|
38,326
|
|
|
$
|
18,991
|
|
Cancer vaccines
|
10,346
|
|
|
7,878
|
|
|
33,807
|
|
|
24,699
|
|
||||
Intratumoral immuno-oncology
|
4,205
|
|
|
2,534
|
|
|
11,398
|
|
|
13,098
|
|
||||
Localized regenerative therapeutics
|
1
|
|
|
5
|
|
|
17
|
|
|
85
|
|
||||
Systemic secreted therapeutics
|
1,296
|
|
|
2,803
|
|
|
10,413
|
|
|
11,866
|
|
||||
Systemic intracellular therapeutics
|
5,039
|
|
|
10,887
|
|
|
21,611
|
|
|
29,814
|
|
||||
Total program-specific expenses by modality (1)
|
26,553
|
|
|
28,606
|
|
|
115,572
|
|
|
98,553
|
|
||||
Other research and development expenses:
|
|
|
|
|
|
|
|
||||||||
Discovery programs
|
13,829
|
|
|
8,593
|
|
|
42,379
|
|
|
24,271
|
|
||||
Platform research
|
21,940
|
|
|
25,747
|
|
|
70,693
|
|
|
67,924
|
|
||||
Technical development and unallocated manufacturing expenses
|
29,372
|
|
|
26,467
|
|
|
69,231
|
|
|
59,302
|
|
||||
Shared discovery and development expenses
|
15,405
|
|
|
9,929
|
|
|
44,643
|
|
|
29,105
|
|
||||
Stock-based compensation
|
12,616
|
|
|
9,708
|
|
|
36,268
|
|
|
24,498
|
|
||||
Total research and development expenses
|
$
|
119,715
|
|
|
$
|
109,050
|
|
|
$
|
378,786
|
|
|
$
|
303,653
|
|
|
|
|
|
|
|
|
|
(1)
|
Include a total of 21 development candidates for both September 30, 2019 and 2018. Program-specific expenses include external costs and allocated manufacturing costs of mRNA supply and consumables, and are reflected as of the beginning of the period in which the program was internally advanced to development or removed if development was ceased.
|
•
|
scope, progress, and expense of developing ongoing and future development candidates and investigational medicines;
|
•
|
entry in and completion of related preclinical studies;
|
•
|
enrollment in and completion of subsequent clinical trials;
|
•
|
safety and efficacy of investigational medicines resulting from these clinical trials;
|
•
|
changes in laws or regulations relevant to the investigational medicines in development;
|
•
|
receipt of the required regulatory approvals; and
|
•
|
commercialization, including establishing manufacturing and marketing capabilities.
|
|
Three Months Ended September 30,
|
|
Change 2019 vs. 2018
|
||||||||||
|
2019
|
|
2018
|
|
$
|
|
%
|
||||||
Revenue:
|
|
|
|
|
|
|
|
||||||
Collaboration revenue
|
$
|
13,338
|
|
|
$
|
36,662
|
|
|
$
|
(23,324
|
)
|
|
(64)%
|
Grant revenue
|
3,708
|
|
|
5,095
|
|
|
(1,387
|
)
|
|
(27)%
|
|||
Total revenue
|
17,046
|
|
|
41,757
|
|
|
(24,711
|
)
|
|
(59)%
|
|||
Operating Expenses:
|
|
|
|
|
|
|
|
||||||
Research and development
|
119,715
|
|
|
109,050
|
|
|
10,665
|
|
|
10%
|
|||
General and administrative
|
28,188
|
|
|
18,525
|
|
|
9,663
|
|
|
52%
|
|||
Total operating expenses
|
147,903
|
|
|
127,575
|
|
|
20,328
|
|
|
16%
|
|||
Loss from operations
|
(130,857
|
)
|
|
(85,818
|
)
|
|
(45,039
|
)
|
|
52%
|
|||
Interest income
|
9,252
|
|
|
6,519
|
|
|
2,733
|
|
|
42%
|
|||
Other expense, net
|
(1,767
|
)
|
|
(1,032
|
)
|
|
(735
|
)
|
|
71%
|
|||
Loss before income taxes
|
(123,372
|
)
|
|
(80,331
|
)
|
|
(43,041
|
)
|
|
54%
|
|||
Benefit from income taxes
|
(178
|
)
|
|
—
|
|
|
(178
|
)
|
|
|
|||
Net loss
|
$
|
(123,194
|
)
|
|
$
|
(80,331
|
)
|
|
$
|
(42,863
|
)
|
|
53%
|
|
Nine Months Ended September 30,
|
|
Change 2019 vs. 2018
|
||||||||||
|
2019
|
|
2018
|
|
$
|
|
%
|
||||||
Revenue:
|
|
|
|
|
|
|
|
||||||
Collaboration revenue
|
$
|
37,483
|
|
|
$
|
89,696
|
|
|
$
|
(52,213
|
)
|
|
(58)%
|
Grant revenue
|
8,671
|
|
|
9,951
|
|
|
(1,280
|
)
|
|
(13)%
|
|||
Total revenue
|
46,154
|
|
|
99,647
|
|
|
(53,493
|
)
|
|
(54)%
|
|||
Operating Expenses:
|
|
|
|
|
|
|
|
||||||
Research and development
|
378,786
|
|
|
303,653
|
|
|
75,133
|
|
|
25%
|
|||
General and administrative
|
83,994
|
|
|
56,229
|
|
|
27,765
|
|
|
49%
|
|||
Total operating expenses
|
462,780
|
|
|
359,882
|
|
|
102,898
|
|
|
29%
|
|||
Loss from operations
|
(416,626
|
)
|
|
(260,235
|
)
|
|
(156,391
|
)
|
|
60%
|
|||
Interest income
|
30,546
|
|
|
18,129
|
|
|
12,417
|
|
|
68%
|
|||
Other expense, net
|
(5,351
|
)
|
|
(1,044
|
)
|
|
(4,307
|
)
|
|
413%
|
|||
Loss before income taxes
|
(391,431
|
)
|
|
(243,150
|
)
|
|
(148,281
|
)
|
|
61%
|
|||
(Benefit from) provision for income taxes
|
(526
|
)
|
|
158
|
|
|
(684
|
)
|
|
|
|||
Net loss
|
$
|
(390,905
|
)
|
|
$
|
(243,308
|
)
|
|
$
|
(147,597
|
)
|
|
61%
|
|
Three Months Ended September 30,
|
|
Change 2019 vs. 2018
|
||||||||||
|
2019
|
|
2018
|
|
$
|
|
%
|
||||||
Gain on investments
|
$
|
79
|
|
|
$
|
771
|
|
|
$
|
(692
|
)
|
|
(90)%
|
Interest expense
|
(1,543
|
)
|
|
(1,519
|
)
|
|
(24
|
)
|
|
2%
|
|||
Other expense, net
|
(303
|
)
|
|
(284
|
)
|
|
(19
|
)
|
|
7%
|
|||
Total other expense, net
|
$
|
(1,767
|
)
|
|
$
|
(1,032
|
)
|
|
$
|
(735
|
)
|
|
|
|
Nine Months Ended September 30,
|
|
Change 2019 vs. 2018
|
||||||||||
|
2019
|
|
2018
|
|
$
|
|
%
|
||||||
Gain on investments
|
$
|
93
|
|
|
$
|
1,362
|
|
|
$
|
(1,269
|
)
|
|
(93)%
|
Interest expense
|
(4,617
|
)
|
|
(1,571
|
)
|
|
(3,046
|
)
|
|
194%
|
|||
Other expense, net
|
(827
|
)
|
|
(835
|
)
|
|
8
|
|
|
(1)%
|
|||
Total other expense, net
|
$
|
(5,351
|
)
|
|
$
|
(1,044
|
)
|
|
$
|
(4,307
|
)
|
|
|
|
Nine Months Ended September 30,
|
||||||
|
2019
|
|
2018
|
||||
Net cash (used in) provided by:
|
|
|
|
||||
Operating activities
|
$
|
(363,195
|
)
|
|
$
|
(239,845
|
)
|
Investing activities
|
(145,293
|
)
|
|
(379,267
|
)
|
||
Financing activities
|
23,531
|
|
|
650,927
|
|
||
Net (decrease) increase in cash, cash equivalents and restricted cash
|
$
|
(484,957
|
)
|
|
$
|
31,815
|
|
Exhibit No.
|
|
Exhibit Index
|
|
|
|
10.1
|
|
|
31.1
|
|
|
31.2
|
|
|
32.1+
|
|
|
101.INS
|
|
XBRL Instance Document
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Document
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
101.LAB
|
|
XBRL Taxonomy Extension Label Linkbase Document
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Link Document
|
|
|
|
|
+
|
The certification furnished in Exhibit 32.1 hereto is deemed to accompany this Form 10-Q and will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended. Such certification will not be deemed to be incorporated by reference into any filings under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except to the extent that the Registrant specifically incorporates it by reference.
|
†
|
Portions of this exhibit (indicated by asterisks) have been omitted in accordance with the rules of the Securities and Exchange Commission.
|
|
|
|
|
|
|
|
MODERNA, INC.
|
|
|
|
|
Date:
|
|
By:
|
/s/ Stéphane Bancel
|
November 6, 2019
|
|
|
|
|
|
|
Stéphane Bancel
|
|
|
|
Chief Executive Officer and Director
|
|
|
|
(Principal Executive Officer)
|
|
|
|
|
Date:
|
|
By:
|
/s/ Lorence Kim, M.D.
|
November 6, 2019
|
|
|
|
|
|
|
Lorence Kim, M.D.
|
|
|
|
Chief Financial Officer
|
|
|
|
(Principal Financial Officer)
|
|
|
|
|
1.
|
Base Term. The Base Term of the Lease is hereby extended with respect to the entire Premises through the Fifth Amendment Expiration Date. Tenant’s occupancy of the Premises through the Fifth Amendment Expiration Date shall be on an “as-is” basis and, except as otherwise expressly provided in Section 3 below, Landlord shall have no obligation to provide any tenant improvement allowance or make any alterations to the Premises.
|
2.
|
Base Rent. Tenant shall continue to pay Base Rent as provided in the Lease through December 31, 2027. Thereafter, Base Rent shall continue to increase by the Rent Adjustment Percentage on each January 1st during the Base Term through the Fifth Amendment Expiration Date.
|
3.
|
Tenant Improvements. Landlord shall make available a tenant improvement allowance to Tenant in the amount of $2,346,000 for the design and construction of improvements by Tenant pursuant to the Fifth Amendment Work Letter.
|
4.
|
Brokers. Landlord and Tenant each represents and warrants that it has not dealt with any broker, agent or other person (collectively, “Broker”) in connection with the transaction reflected in this Fifth Amendment and that no Broker brought about this transaction, other than Jones Lang LaSalle. Landlord and Tenant each hereby agrees to indemnify and hold the other harmless from and against any claims by any Broker claiming a commission or other form of compensation by virtue of having dealt with Tenant or Landlord, as applicable, with regard to this Fifth Amendment.
|
5.
|
OFAC. Tenant and all beneficial owners of Tenant are currently (a) in compliance with and shall at all times during the Term of the Lease remain in compliance with the regulations of the Office of Foreign Assets Control (“OFAC”) of the U.S. Department of Treasury and any statute, executive order, or regulation relating thereto (collectively, the “OFAC Rules”), (b) not listed on, and shall not during the term of the Lease be listed on, the Specially Designated Nationals and Blocked Persons List, Foreign Sanctions Evaders List or the Sectoral Sanctions Identifications List, which are all maintained by OFAC and/or on any other similar list maintained by OFAC or other governmental authority pursuant to any authorizing statute, executive order, or regulation, and (c) not a person or entity with whom a U.S. person is prohibited from conducting business under the OFAC Rules.
|
6.
|
Miscellaneous.
|
Date: November 6, 2019
|
|
By:
|
/s/ Stéphane Bancel
|
|
|
|
Stéphane Bancel
|
|
|
|
Chief Executive Officer
|
|
|
|
(Principal Executive Officer)
|
Date: November 6, 2019
|
|
By:
|
/s/ Lorence Kim
|
|
|
|
Lorence Kim M.D.
|
|
|
|
Chief Financial Officer
(Principal Financial Officer)
|
1.
|
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
|
2.
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
Date: November 6, 2019
|
|
By:
|
/s/ Stéphane Bancel
|
|
|
|
Stéphane Bancel
|
|
|
|
Chief Executive Officer
|
|
|
|
(Principal Executive Officer)
|
|
|
|
|
Date: November 6, 2019
|
|
By:
|
/s/ Lorence Kim
|
|
|
|
Lorence Kim, M.D.
|
|
|
|
Chief Financial Officer
|
|
|
|
(Principal Financial Officer)
|
|
|
|
|