MannKind Corporation (Nasdaq: MNKD) today reported
financial results for the quarter ended March 31, 2023.
“Demand for Tyvaso DPI® has been very strong, which
resulted in $23 million in revenues in the first quarter of 2023,”
said Michael Castagna, PharmD, Chief Executive Officer of MannKind
Corporation. “I'm excited about our inhaled platform and orphan
lung pipeline as we get ready to launch our Phase 2/3 inhaled
clofazimine trial for patients in the second half of 2023.”
Revenue Highlights
|
Three Months Ended March 31, |
|
|
2023 |
|
2022 |
|
$ Change |
|
% Change |
|
|
(Dollars in thousands) |
|
Net revenue – Afrezza |
$ |
12,423 |
|
$ |
9,826 |
|
$ |
2,597 |
|
26 |
% |
Net revenue – V-Go |
|
5,139 |
|
|
— |
|
$ |
5,139 |
|
* |
|
Revenue – collaborations and
services |
|
11,386 |
|
|
2,166 |
|
$ |
9,220 |
|
426 |
% |
Royalties – collaborations |
|
11,678 |
|
|
— |
|
$ |
11,678 |
|
* |
|
Total revenues |
$ |
40,626 |
|
$ |
11,992 |
|
$ |
28,634 |
|
239 |
% |
___________________* Not meaningful
Afrezza® net revenue for the first quarter of 2023
increased compared to the same period in 2022 as a result of higher
product demand, higher price (including a more favorable
gross-to-net adjustment) and a more favorable cartridge mix. V-Go®
was acquired in the second quarter of 2022. The increase in
collaborations and services revenue reflected that the commercial
manufacturing of Tyvaso DPI had not yet commenced in the prior
period. Royalties related to Tyvaso DPI, launched in the second
quarter of 2022 by United Therapeutics (“UT”), continued to grow
based on strong patient demand.
Commercial product gross margin in the first
quarter of 2023 was 69% compared to 77% for the same period in 2022
primarily related to the addition of V-Go in the second quarter of
2022 which had a lower gross margin than Afrezza.
Cost of revenue – collaborations and services for
the first quarter of 2023 was $10.7 million compared to $8.7
million for the same period in 2022, an increase of $2.0 million,
due to an increase in manufacturing activities for Tyvaso DPI.
Research and development expenses for the first
quarter of 2023 were $5.6 million compared to $3.5 million for the
same period in 2022. The $2.1 million increase was primarily
attributed to costs incurred to develop our product pipeline,
including MNKD-101 (inhaled clofazimine) and the Afrezza pediatrics
clinical study (INHALE-1).
Selling expenses for the first quarter of 2023 were
$13.3 million compared to $12.7 million for the same period in
2022. The $0.6 million increase was primarily due to V-Go
promotional efforts and increased headcount after the acquisition
in the second quarter of 2022 as well as an increase in Afrezza
promotional activities, partially offset by the termination of an
Afrezza pilot promotional effort targeting primary care physicians
which ended in the third quarter of 2022.
General and administrative expenses for the first
quarter of 2023 were $10.5 million compared to $7.9 million for the
same period in 2022. The $2.6 million increase was primarily
attributable to higher stock-based compensation, increased
headcount, and higher professional fees.
Interest expense on financing liability was $2.4
million for the first quarter of 2023 and remained consistent with
the same period in 2022.
Interest expense on notes was $2.8 million in the
first quarter of 2023 and remained consistent with the same period
in 2022 due to fixed interest rates and no changes in debt
balances.
Cash, cash equivalents and investments as of
March 31, 2023 were $166.6 million.
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 MannKind’s pipeline
advancement, including the planned launch of MannKind's inhaled
clofazimine trial for patients in the second half of 2023. 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 these
risks and uncertainties, which include, without limitation, risks
associated with manufacturing and supply, risks associated with
product commercialization, risks associated with developing product
candidates, risks associated with MannKind’s ability to manage its
existing cash resources or raise additional cash resources, 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, 2022, filed with the SEC on February 23, 2023,
and under the “Risk Factors” heading of its Quarterly Report on
Form 10-Q for the quarter ended March 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 CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
|
|
|
|
Three Months Ended March 31, |
|
|
2023 |
|
|
2022 |
|
|
(In
thousands except per share data) |
|
Revenues: |
|
|
|
|
|
Net revenue – commercial product sales |
$ |
17,562 |
|
|
$ |
9,826 |
|
Revenue – collaborations and services |
|
11,386 |
|
|
|
2,166 |
|
Royalties – collaborations |
|
11,678 |
|
|
|
— |
|
Total revenues |
|
40,626 |
|
|
|
11,992 |
|
Expenses: |
|
|
|
|
|
Cost of goods sold |
|
5,530 |
|
|
|
2,284 |
|
Cost of revenue – collaborations and services |
|
10,683 |
|
|
|
8,714 |
|
Research and development |
|
5,605 |
|
|
|
3,536 |
|
Selling |
|
13,310 |
|
|
|
12,728 |
|
General and administrative |
|
10,542 |
|
|
|
7,969 |
|
Loss (gain) on foreign currency transaction |
|
954 |
|
|
|
(1,983 |
) |
Total expenses |
|
46,624 |
|
|
|
33,248 |
|
Loss from operations |
|
(5,998 |
) |
|
|
(21,256 |
) |
Other (expense) income: |
|
|
|
|
|
Interest income, net |
|
1,302 |
|
|
|
377 |
|
Interest expense on financing liability |
|
(2,424 |
) |
|
|
(2,371 |
) |
Interest expense on notes |
|
(2,786 |
) |
|
|
(2,748 |
) |
Other income |
|
111 |
|
|
|
— |
|
Total other expense |
|
(3,797 |
) |
|
|
(4,742 |
) |
Loss before income tax
expense |
|
(9,795 |
) |
|
|
(25,998 |
) |
Benefit from income taxes |
|
— |
|
|
|
— |
|
Net loss |
$ |
(9,795 |
) |
|
$ |
(25,998 |
) |
Net loss per share – basic and
diluted |
$ |
(0.04 |
) |
|
$ |
(0.10 |
) |
Shares used to compute net loss
per share – basic and diluted |
|
263,969 |
|
|
|
251,887 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MANNKIND CORPORATION AND
SUBSIDIARY CONDENSED CONSOLIDATED BALANCE
SHEETS
|
|
|
|
March 31, |
|
|
2023 |
|
|
2022 |
|
|
(In thousands except share and per share
data) |
|
ASSETS |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
85,869 |
|
|
$ |
69,767 |
|
Short-term investments |
|
80,273 |
|
|
|
101,079 |
|
Accounts receivable, net |
|
19,714 |
|
|
|
16,801 |
|
Inventory |
|
21,998 |
|
|
|
21,772 |
|
Prepaid expenses and other current assets |
|
15,445 |
|
|
|
25,477 |
|
Total current assets |
|
223,299 |
|
|
|
234,896 |
|
Property and equipment, net |
|
54,837 |
|
|
|
45,126 |
|
Goodwill |
|
1,998 |
|
|
|
2,428 |
|
Other intangible asset |
|
1,133 |
|
|
|
1,153 |
|
Long-term investments |
|
492 |
|
|
|
1,961 |
|
Other assets |
|
16,378 |
|
|
|
9,718 |
|
Total assets |
$ |
298,137 |
|
|
$ |
295,282 |
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' DEFICIT |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
13,889 |
|
|
$ |
11,052 |
|
Accrued expenses and other current liabilities |
|
32,995 |
|
|
|
35,553 |
|
Financing liability – current |
|
9,626 |
|
|
|
9,565 |
|
Midcap credit facility – current |
|
11,667 |
|
|
|
— |
|
Deferred revenue – current |
|
2,316 |
|
|
|
1,733 |
|
Recognized loss on purchase commitments – current |
|
11,360 |
|
|
|
9,393 |
|
Total current liabilities |
|
81,853 |
|
|
|
67,296 |
|
Mann Group convertible note |
|
8,829 |
|
|
|
8,829 |
|
Accrued interest – Mann Group convertible note |
|
54 |
|
|
|
55 |
|
Financing liability – long term |
|
94,441 |
|
|
|
94,512 |
|
Midcap credit facility |
|
27,704 |
|
|
|
39,264 |
|
Senior convertible notes |
|
225,761 |
|
|
|
225,397 |
|
Recognized loss on purchase commitments – long term |
|
59,829 |
|
|
|
62,916 |
|
Operating lease liability |
|
4,879 |
|
|
|
5,343 |
|
Deferred revenue – long term |
|
45,659 |
|
|
|
37,684 |
|
Milestone liabilities |
|
4,524 |
|
|
|
4,524 |
|
Deposits from customer |
|
— |
|
|
|
— |
|
Total liabilities |
|
553,533 |
|
|
|
545,820 |
|
Stockholders' deficit: |
|
|
|
|
|
Undesignated preferred stock, $0.01 par value – 10,000,000 shares
authorized; no shares issued or outstanding as of
March 31, 2023 and December 31, 2022 |
|
— |
|
|
|
— |
|
Common stock, $0.01 par value – 400,000,000 shares authorized,
264,278,760 and 263,793,305 shares issued and
outstanding as of March 31, 2023 and December 31,
2022, respectively |
|
2,643 |
|
|
|
2,638 |
|
Additional paid-in capital |
|
2,969,225 |
|
|
|
2,964,293 |
|
Accumulated deficit |
|
(3,227,264 |
) |
|
|
(3,217,469 |
) |
Total stockholders' deficit |
|
(255,396 |
) |
|
|
(250,538 |
) |
Total liabilities and stockholders' deficit |
$ |
298,137 |
|
|
$ |
295,282 |
|
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