MannKind Corporation (Nasdaq: MNKD) today reported
financial results for the quarter and full year ended
December 31, 2023.
“We doubled our total revenues to nearly $200 million in 2023
and ended the year with a robust fourth quarter total revenue of
$58 million,” said Michael Castagna, PharmD, Chief Executive
Officer of MannKind Corporation. "With our strong year-end cash
position of over $300 million, we are well positioned to capitalize
on upcoming data read-outs for Afrezza and move MNKD-101
(clofazimine inhalation suspension) into phase 3 and MNKD-201
(nintedanib DPI) into phase 1 in the first half of 2024."
Fourth Quarter 2023 Results
Revenue Highlights
|
|
|
Three Months Ended December 31, |
|
|
|
|
2023 |
|
|
2022 |
|
|
$ Change |
|
|
% Change |
|
|
|
|
(Dollars in thousands) |
|
|
Net revenue – Afrezza |
|
$ |
15,487 |
|
|
$ |
12,006 |
|
|
$ |
3,481 |
|
|
|
29 |
% |
| Net revenue – V-Go |
|
|
4,708 |
|
|
|
5,434 |
|
|
$ |
(726 |
) |
|
|
(13 |
%) |
| Revenue – collaborations and
services |
|
|
17,249 |
|
|
|
9,544 |
|
|
$ |
7,705 |
|
|
|
81 |
% |
| Royalties – collaborations |
|
|
21,028 |
|
|
|
9,075 |
|
|
$ |
11,953 |
|
|
|
132 |
% |
|
Total revenues |
|
$ |
58,472 |
|
|
$ |
36,059 |
|
|
$ |
22,413 |
|
|
|
62 |
% |
|
|
Afrezza® net revenue for the fourth quarter of 2023 increased
$3.5 million, or 29%, compared to the same period in 2022 as a
result of higher product demand and higher price (including a
decrease in gross-to-net adjustments as a percentage of gross
sales). V-Go® net revenue for the fourth quarter of 2023 decreased
$0.7 million, or 13%, compared to the same period in 2022 as a
result of lower product demand and an increase in rebates (as a
percentage of gross sales). Collaborations and services revenue
increased $7.7 million, or 81%, compared to the same period in 2022
primarily attributable to an increase in manufacturing Tyvaso DPI
for United Therapeutics ("UT"). Royalties related to Tyvaso DPI for
the fourth quarter of 2023 increased $12.0 million, or 132%,
primarily as a result of increased patient demand.
Commercial product gross margin in the fourth quarter of 2023
was 70% compared to 77% for the same period in 2022. The decrease
in gross margin was primarily attributable to an increase in cost
of goods sold for Afrezza due to the timing of the capitalization
of costs to inventory and lower net revenue for V-Go.
Cost of revenue – collaborations and services was $12.0 million
for the fourth quarter of 2023 and remained consistent with the
same period in 2022. Higher manufacturing volumes resulted in
efficiencies which contributed to a lower effective cost per
unit.
Research and development ("R&D") expenses for the fourth
quarter of 2023 were $9.2 million compared to $7.2 million for the
same period in 2022. The $2.1 million increase was primarily
attributed to increased development activities for INHALE-3 which
commenced in the second quarter of 2023, INHALE-1 and other
research and development activities, partially offset by a decrease
in development activities for MNKD-101 due to the completion of a
toxicology study in 2022.
Selling expenses were $11.0 million in the fourth quarter of
2023 compared to $11.6 million for the same period in 2022. The
$0.6 million decrease was primarily due to lower promotional
activities.
General and administrative expenses for the fourth quarter of
2023 were $9.5 million compared to $10.5 million for the same
period in 2022. The $1.0 million decrease was primarily
attributable to a decrease in personnel and consulting costs.
Interest income was $1.7 million for the fourth quarter of 2023
compared to $1.0 million for the same period in 2022. The $0.8
million increase was primarily due to higher yields on our
marketable securities and money market funds.
Interest expense on notes was $2.5 million and interest expense
on financing liability (related to the sale-leaseback of our
Danbury manufacturing facility) was $2.7 million for the fourth
quarter of 2023 and remained consistent with the same period in
2022.
Loss on available-for-sale securities for the fourth quarter of
2023 was $1.1 million as a result of the change in fair value of
the investment which related to credit risk.
Year Ended December 31, 2023
Revenue Highlights
|
|
|
Year Ended December 31, |
|
|
|
|
2023 |
|
|
2022 |
|
|
$ Change |
|
|
% Change |
|
|
|
|
(Dollars in thousands) |
|
|
Net revenue – Afrezza |
|
$ |
54,914 |
|
|
$ |
43,316 |
|
|
$ |
11,598 |
|
|
|
27 |
% |
| Net revenue – V-Go |
|
|
19,115 |
|
|
|
12,931 |
|
|
$ |
6,184 |
|
|
|
48 |
% |
| Revenue – collaborations and
services |
|
|
52,954 |
|
|
|
27,924 |
|
|
$ |
25,030 |
|
|
|
90 |
% |
| Royalties – collaborations |
|
|
71,979 |
|
|
|
15,599 |
|
|
$ |
56,380 |
|
|
* |
|
|
Total revenues |
|
$ |
198,962 |
|
|
$ |
99,770 |
|
|
$ |
99,192 |
|
|
|
99 |
% |
________________________* Not meaningful
Afrezza net revenue for the year ended December 31, 2023
increased $11.6 million, or 27%, compared to the same period in
2022 primarily as a result of higher product demand and price
(including a decrease in gross-to-net adjustments as a percentage
of gross sales). V-Go net revenue for the year ended December 31,
2023 increased $6.2 million, compared to the same period in 2022.
The increase reflects a full year of sales in 2023 compared to
seven months in 2022 after V-Go was acquired in May of that year.
Net revenue from collaborations and services for the year ended
December 31, 2023 increased $25.0 million, or 90%, primarily as a
result of an increase in manufacturing Tyvaso DPI for UT and the
deferral of manufacturing revenue in the prior year period until we
began commercial manufacturing in May 2022. Royalties related to
Tyvaso DPI, launched in the late second quarter of 2022 by UT,
reached $72.0 million for the year ended December 31, 2023,
reflecting a full year of sales and increasing patient demand over
the period.
Commercial product gross margin was 72% for the year ended
December 31, 2023 and remained consistent with the same period in
2022.
Cost of revenue – collaborations and services for the year ended
December 31, 2023 was $41.9 million and remained consistent with
the same period in 2022 as manufacturing activities shifted from
preproduction efforts in the first five months of 2022 to full
commercial production of Tyvaso DPI thereafter. Higher
manufacturing volumes resulted in efficiencies which contributed to
a lower effective cost per unit.
R&D expenses for the year ended December 31, 2023 were $31.3
million compared to $19.7 million for the same period in 2022. The
$11.6 million increase was primarily attributed to increases in
development activities for MNKD-101, costs for INHALE-3, which
commenced in the second quarter of 2023, costs for INHALE-1 and
other research and development activities.
Selling expenses for the year ended December 31, 2023 were $51.8
million compared to $53.8 million for the same period in 2022. The
$2.0 million decrease was primarily due to the termination of an
Afrezza pilot promotional effort with a contract sales force
targeting primary care physicians, which ended in the third quarter
of 2022, partially offset by increased personnel and promotional
activities related to the acquisition of V-Go in the second quarter
of 2022.
General and administrative expenses for the year ended December
31, 2023 were $42.5 million compared to $37.7 million for the same
period in 2022. The $4.8 million increase was primarily
attributable to increased personnel and consulting costs, including
stock-based compensation and headcount.
Interest income was $6.2 million for the year ended December 31,
2023 compared to $2.5 million for the same period in 2022. The
increase was primarily due to higher yields on our marketable
securities and money market funds.
Interest expense on notes and milestone rights was $15.2 million
and interest expense on financing liability was $9.8 million for
the year ended December 31, 2023 and remained consistent with the
same period in 2022.
Loss on available-for-sale securities for the year ended
December 31, 2023 was $0.2 million as a result of the change in the
fair value of the investment which related to credit risk.
Cash, cash equivalents and investments as of December 31,
2023 were $302.3 million.
Non-GAAP Measures
To supplement our consolidated financial statements presented
under U.S. generally accepted accounting principles (GAAP), we are
presenting non-GAAP income (loss) from operations, non-GAAP net
income (loss) and non-GAAP net income (loss) per share - basic,
which are non-GAAP financial measures. We are providing these
non-GAAP financial measures to disclose additional information to
facilitate the comparison of past and present operations, and they
are among the indicators management uses as a basis for evaluating
our financial performance. We believe that these non-GAAP financial
measures, when considered together with our GAAP financial results,
provide management and investors with an additional understanding
of our business operating results, including underlying trends.
These non-GAAP financial measures are not meant to be considered
in isolation or as a substitute for comparable GAAP measures;
should be read in conjunction with our consolidated financial
statements prepared in accordance with GAAP; have no standardized
meaning prescribed by GAAP; and are not prepared under any
comprehensive set of accounting rules or principles. In addition,
from time to time in the future there may be other items that we
may exclude for purposes of our non-GAAP financial measures; and we
may in the future cease to exclude items that we have historically
excluded for purposes of our non-GAAP financial measures. Likewise,
we may determine to modify the nature of adjustments to arrive at
our non-GAAP financial measures. Because of the non-standardized
definitions of non-GAAP financial measures, the non-GAAP financial
measures as used by us in this report have limits in their
usefulness to investors and may be calculated differently from, and
therefore may not be directly comparable to, similarly titled
measures used by other companies.
The following table reconciles our financial measure for income
(loss) from operations, net income (loss) and net income (loss) per
share ("EPS") for basic and diluted weighted average shares as
reported in our consolidated statement of operations to a non-GAAP
presentation as adjusted for select non-cash items: 1% royalty on
net revenues for Tyvaso DPI ("Sold portion of royalty revenue") and
interest expense on the related liability, stock-based compensation
expense, gain on foreign currency transaction and gain on
available-for-sale securities for the periods presented (in
thousands, except per share amounts):
| |
Three Months |
|
Year |
|
| |
Ended December 31, |
|
Ended December 31, |
|
| |
2023 |
|
2022 |
|
2023 |
|
2022 |
|
|
|
(In thousands except per share data) |
|
|
GAAP income (loss) from operations |
$ |
7,858 |
|
$ |
(12,790 |
) |
$ |
8,678 |
|
$ |
(64,110 |
) |
| Select non-cash
adjustments: |
|
|
|
|
|
|
|
|
| Sold
portion of royalty revenue (1) |
|
(2,103 |
) |
|
— |
|
|
(2,103 |
) |
|
— |
|
| Stock
compensation |
|
3,786 |
|
|
2,597 |
|
|
17,649 |
|
|
13,447 |
|
| Loss (gain)
on foreign currency transaction |
|
2,776 |
|
|
3,474 |
|
|
1,916 |
|
|
(4,811 |
) |
| Non-GAAP income (loss) from
operations |
$ |
12,317 |
|
$ |
(6,719 |
) |
$ |
26,140 |
|
$ |
(55,474 |
) |
| |
|
|
|
|
|
|
|
|
| GAAP net income
(loss) |
$ |
1,401 |
|
$ |
(17,947 |
) |
$ |
(11,938 |
) |
$ |
(87,400 |
) |
| Select non-cash
adjustments: |
|
|
|
|
|
|
|
|
| Sold
portion of royalty revenue (1) |
|
(2,103 |
) |
|
— |
|
|
(2,103 |
) |
|
— |
|
| Stock
compensation |
|
3,786 |
|
|
2,597 |
|
|
17,649 |
|
|
13,447 |
|
| Loss (gain)
on foreign currency transaction |
|
2,776 |
|
|
3,474 |
|
|
1,916 |
|
|
(4,811 |
) |
| Interest
expense on liability for sale of future royalties |
|
185 |
|
|
— |
|
|
185 |
|
|
— |
|
| Loss on
available-for-sale securities |
|
1,102 |
|
|
932 |
|
|
170 |
|
|
932 |
|
| Non-GAAP net income
(loss) |
$ |
7,147 |
|
$ |
(10,944 |
) |
$ |
5,879 |
|
$ |
(77,832 |
) |
| |
|
|
|
|
|
|
|
|
| GAAP net income (loss)
per share - basic |
$ |
0.01 |
|
$ |
(0.07 |
) |
$ |
(0.04 |
) |
$ |
(0.34 |
) |
| Select non-cash
adjustments: |
|
|
|
|
|
|
|
|
| Sold
portion of royalty revenue |
|
(0.01 |
) |
|
0.00 |
|
|
(0.01 |
) |
|
0.00 |
|
| Stock
compensation |
|
0.01 |
|
|
0.01 |
|
|
0.07 |
|
|
0.05 |
|
| Loss (gain)
on foreign currency transaction |
|
0.01 |
|
|
0.01 |
|
|
0.01 |
|
|
(0.02 |
) |
| Interest
expense on liability for sale of future royalties |
|
0.00 |
|
|
0.00 |
|
|
0.00 |
|
|
0.00 |
|
| Loss on
available-for-sale securities |
|
0.00 |
|
|
0.00 |
|
|
0.00 |
|
|
0.00 |
|
| Non-GAAP net income (loss) per
share - basic |
$ |
0.02 |
|
$ |
(0.05 |
) |
$ |
0.03 |
|
$ |
(0.31 |
) |
| |
|
|
|
|
|
|
|
|
| Weighted average shares -
basic |
|
269,648 |
|
|
263,378 |
|
|
267,014 |
|
|
257,092 |
|
__________________________
|
(1) |
Represents the non-cash portion of the 1% royalty on net sales of
Tyvaso DPI earned during 4Q 2023 which is remitted to the royalty
purchaser and recognized as royalties from collaborations in our
consolidated statements of operations. Our revenues from
royalties from collaborations during 4Q 2023 totaled $21.0 million,
of which $2.1 million will be remitted to the royalty
purchaser. |
|
|
|
Clinical Development Update
Afrezza INHALE-1 (pediatric phase 3 clinical
trial)
- Enrollment completed in February 2024
- Upcoming expected data read-outs:
- Primary endpoint analysis in 4Q 2024
- Full results in 1H 2025
- FDA submission for label expansion expected in 2025
Afrezza INHALE-3 (T1DM, Afrezza vs. standard of care
including AID pumps; phase 4 clinical trial)
- Enrollment completed ahead of schedule in 4Q 2023
- Upcoming expected data read-outs:
- First meal dosing – ATTD oral presentation in March 2024
- 17-week top-line data/primary endpoints to be presented at ADA
in June 2024
- Additional data to be presented at ADCES August conference
MNKD-101 (clofazimine inhalation
suspension)
- Phase 3 development program aligned with the FDA – IND expected
to be filed in 1Q 2024
- Co-primary endpoints of sputum conversion and patient-reported
outcomes
- Up to 100 global sites, first patient expected to enroll in 2Q
2024
MNKD-201 (nintedanib DPI)
- Phase 1 development program in healthy volunteers, expected to
dose first patient in 2Q 2024
- Results expected in late 2024
Conference Call
MannKind will host a conference call and presentation webcast to
discuss these results today at 5:00 p.m. Eastern Time. Those
interested in listening to the conference call live via the
Internet may do so by visiting the Company’s website at
mannkindcorp.com under Events & Presentations. A replay will be
available on MannKind's website for 14 days.
About MannKind
MannKind Corporation (Nasdaq: MNKD) focuses on the development
and commercialization of inhaled therapeutic products for patients
with endocrine and orphan lung diseases.
We are committed to using our formulation capabilities and
device engineering prowess to lessen the burden of diseases such as
diabetes, pulmonary arterial hypertension (PAH) and nontuberculous
mycobacterial (NTM) lung disease. Our signature technologies –
dry-powder formulations and inhalation devices – offer rapid and
convenient delivery of medicines to the deep lung where they can
exert an effect locally or enter the systemic circulation.
With a passionate team of Mannitarians collaborating nationwide,
we are on a mission to give people control of their health and the
freedom to live life.
Please visit mannkindcorp.com to learn more, and follow us on
LinkedIn, Facebook, Twitter or Instagram.
Forward-Looking Statements
Statements in this press release that are not statements of
historical fact are forward-looking statements that involve risks
and uncertainties. These statements include, without
limitation, statements regarding the commencement of clinical
studies of MNKD-101 and MNKD-201, FDA submissions and the data
read-outs from clinical studies of Afrezza and MNKD-201. Words such
as “believes,” “anticipates,” “plans,” “expects,” “intend,” “will,”
“goal,” “potential” and similar expressions are intended to
identify forward-looking statements. These forward-looking
statements are based upon MannKind’s current expectations. Actual
results and the timing of events could differ materially from those
anticipated in such forward-looking statements as a result of
various risks and uncertainties, which include, without limitation,
risks associated with manufacturing and supply, risks associated
with developing product candidates, and other risks detailed in
MannKind’s filings with the Securities and Exchange Commission
(“SEC”), including under the “Risk Factors” heading of its Annual
Report on Form 10-K for the year ended December 31, 2023,
being filed with the SEC later today. You are cautioned not to
place undue reliance on these forward-looking statements, which
speak only as of the date of this press release. All
forward-looking statements are qualified in their entirety by this
cautionary statement, and MannKind undertakes no obligation to
revise or update any forward-looking statements to reflect events
or circumstances after the date of this press release.
Tyvaso DPI is a trademark of United Therapeutics
Corporation.
AFREZZA, MANNKIND, and V-GO are registered trademarks of
MannKind Corporation.
MannKind Contact:Rose Alinaya, Investor
Relations(818) 661-5000IR@mannkindcorp.com
|
|
|
MANNKIND CORPORATION AND SUBSIDIARY |
|
CONSOLIDATED STATEMENTS OF OPERATIONS |
|
|
|
|
|
Three Months Ended December 31, |
|
|
Year Ended December 31, |
|
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
|
(In
thousands except per share data) |
|
| Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenue – commercial product sales |
|
$ |
20,195 |
|
|
$ |
17,440 |
|
|
$ |
74,029 |
|
|
$ |
56,247 |
|
|
Revenue – collaborations and services |
|
|
17,249 |
|
|
|
9,544 |
|
|
|
52,954 |
|
|
|
27,924 |
|
|
Royalties – collaborations |
|
|
21,028 |
|
|
|
9,075 |
|
|
|
71,979 |
|
|
|
15,599 |
|
|
Total revenues |
|
|
58,472 |
|
|
|
36,059 |
|
|
|
198,962 |
|
|
|
99,770 |
|
| Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
|
6,114 |
|
|
|
4,081 |
|
|
|
20,863 |
|
|
|
16,003 |
|
|
Cost of revenue – collaborations and services |
|
|
11,953 |
|
|
|
12,043 |
|
|
|
41,908 |
|
|
|
41,494 |
|
|
Research and development |
|
|
9,236 |
|
|
|
7,156 |
|
|
|
31,283 |
|
|
|
19,721 |
|
|
Selling |
|
|
11,024 |
|
|
|
11,616 |
|
|
|
51,776 |
|
|
|
53,753 |
|
|
General and administrative |
|
|
9,511 |
|
|
|
10,479 |
|
|
|
42,538 |
|
|
|
37,720 |
|
|
Loss (gain) on foreign currency transaction |
|
|
2,776 |
|
|
|
3,474 |
|
|
|
1,916 |
|
|
|
(4,811 |
) |
|
Total expenses |
|
|
50,614 |
|
|
|
48,849 |
|
|
|
190,284 |
|
|
|
163,880 |
|
| Income (loss) from
operations |
|
|
7,858 |
|
|
|
(12,790 |
) |
|
|
8,678 |
|
|
|
(64,110 |
) |
| Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
|
1,725 |
|
|
|
957 |
|
|
|
6,154 |
|
|
|
2,513 |
|
|
Interest expense on financing liability |
|
|
(2,493 |
) |
|
|
(2,478 |
) |
|
|
(9,825 |
) |
|
|
(9,758 |
) |
|
Interest expense |
|
|
(2,677 |
) |
|
|
(2,809 |
) |
|
|
(15,151 |
) |
|
|
(15,011 |
) |
|
Interest expense on liability for sale of future royalties |
|
|
(185 |
) |
|
|
— |
|
|
|
(185 |
) |
|
|
— |
|
|
Loss on available-for-sale securities |
|
|
(1,102 |
) |
|
|
(932 |
) |
|
|
(170 |
) |
|
|
(932 |
) |
|
Other income (expense) |
|
|
(164 |
) |
|
|
105 |
|
|
|
122 |
|
|
|
(102 |
) |
|
Total other expense |
|
|
(4,896 |
) |
|
|
(5,157 |
) |
|
|
(19,055 |
) |
|
|
(23,290 |
) |
| Income (loss) before income tax
expense |
|
|
2,962 |
|
|
|
(17,947 |
) |
|
|
(10,377 |
) |
|
|
(87,400 |
) |
| Income tax expense |
|
|
(1,561 |
) |
|
|
— |
|
|
|
(1,561 |
) |
|
|
— |
|
| Net income (loss) |
|
$ |
1,401 |
|
|
$ |
(17,947 |
) |
|
$ |
(11,938 |
) |
|
$ |
(87,400 |
) |
| Net income (loss) per share –
basic |
|
$ |
0.01 |
|
|
$ |
(0.07 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.34 |
) |
| Weighted average shares used to
compute net income (loss) per share – basic |
|
|
269,648 |
|
|
|
263,378 |
|
|
|
267,014 |
|
|
|
257,092 |
|
| Net income (loss) per share –
diluted |
|
$ |
0.00 |
|
|
$ |
(0.07 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.34 |
) |
| Weighted average shares used to
compute net income (loss) per share – diluted |
|
|
323,880 |
|
(1) |
|
263,378 |
|
|
|
267,014 |
|
|
|
257,092 |
|
__________________________
|
(1) |
Diluted weighted average shares differs from basic due to the
weighted average number of shares that would be outstanding upon
conversion of our Senior convertible notes (44,120 shares) and Mann
Group convertible note (3,370 shares), and exercise or vesting of
outstanding share-based payments to employees (6,742 shares). These
adjustments to weighted average shares are only applied to periods
with net income. |
|
MANNKIND CORPORATION AND SUBSIDIARY |
|
CONSOLIDATED BALANCE SHEETS |
|
|
|
|
|
December 31, 2023 |
|
|
December 31, 2022 |
|
|
|
|
(In thousands except share and per share
data) |
|
|
ASSETS |
|
|
|
|
|
|
| Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
238,480 |
|
|
$ |
69,767 |
|
|
Short-term investments |
|
|
56,619 |
|
|
|
101,079 |
|
|
Accounts receivable, net |
|
|
14,901 |
|
|
|
16,801 |
|
|
Inventory |
|
|
28,545 |
|
|
|
21,772 |
|
|
Prepaid expenses and other current assets |
|
|
34,848 |
|
|
|
25,477 |
|
|
Total current assets |
|
|
373,393 |
|
|
|
234,896 |
|
| Property and equipment, net |
|
|
84,220 |
|
|
|
45,126 |
|
| Goodwill |
|
|
1,931 |
|
|
|
2,428 |
|
| Other intangible asset |
|
|
1,073 |
|
|
|
1,153 |
|
| Long-term investments |
|
|
7,155 |
|
|
|
1,961 |
|
| Other assets |
|
|
7,426 |
|
|
|
9,718 |
|
|
Total assets |
|
$ |
475,198 |
|
|
$ |
295,282 |
|
| |
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' DEFICIT |
|
|
|
|
|
|
| Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
|
$ |
9,580 |
|
|
$ |
11,052 |
|
|
Accrued expenses and other current liabilities |
|
|
42,036 |
|
|
|
35,553 |
|
|
Financing liability – current |
|
|
9,809 |
|
|
|
9,565 |
|
|
Midcap credit facility – current |
|
|
20,000 |
|
|
|
— |
|
|
Liability for sale of future royalties – current |
|
|
9,756 |
|
|
|
— |
|
|
Deferred revenue – current |
|
|
9,085 |
|
|
|
1,733 |
|
|
Recognized loss on purchase commitments – current |
|
|
3,859 |
|
|
|
9,393 |
|
|
Total current liabilities |
|
|
104,125 |
|
|
|
67,296 |
|
| Mann Group convertible note |
|
|
8,829 |
|
|
|
8,829 |
|
| Accrued interest – Mann Group
convertible note |
|
|
56 |
|
|
|
55 |
|
| Financing liability – long
term |
|
|
94,319 |
|
|
|
94,512 |
|
| Midcap credit facility – long
term |
|
|
13,019 |
|
|
|
39,264 |
|
| Senior convertible notes |
|
|
226,851 |
|
|
|
225,397 |
|
| Liability for sale of future
royalties – long term |
|
|
136,054 |
|
|
|
— |
|
| Recognized loss on purchase
commitments – long term |
|
|
60,942 |
|
|
|
62,916 |
|
| Operating lease liability |
|
|
3,925 |
|
|
|
5,343 |
|
| Deferred revenue – long term |
|
|
69,794 |
|
|
|
37,684 |
|
| Milestone liabilities |
|
|
3,452 |
|
|
|
4,524 |
|
|
Total liabilities |
|
|
721,366 |
|
|
|
545,820 |
|
| Stockholders' deficit: |
|
|
|
|
|
|
| Undesignated preferred stock,
$0.01 par value – 10,000,000 shares authorized; no shares
issued or outstanding as of December 31, 2023 and 2022 |
|
|
— |
|
|
|
— |
|
| Common stock, $0.01 par value –
800,000,000 and 400,000,000 shares authorized as of
December 31, 2023 and 2022, respectively, and
270,034,495 and 263,793,305 shares issued and outstanding as of
December 31, 2023 and 2022, respectively |
|
|
2,700 |
|
|
|
2,638 |
|
| Additional paid-in capital |
|
|
2,980,539 |
|
|
|
2,964,293 |
|
| Accumulated other comprehensive
income |
|
|
— |
|
|
|
— |
|
| Accumulated deficit |
|
|
(3,229,407 |
) |
|
|
(3,217,469 |
) |
|
Total stockholders' deficit |
|
|
(246,168 |
) |
|
|
(250,538 |
) |
|
Total liabilities and stockholders' deficit |
|
$ |
475,198 |
|
|
$ |
295,282 |
|
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