MannKind Corporation (Nasdaq: MNKD) today reported
financial results for the quarter ended March 31, 2022.
“As we approach the FDA action date for Tyvaso
DPI, our company is focused on supporting United Therapeutics in
their planned commercial launch,” said Michael Castagna, PharmD,
Chief Executive Officer of MannKind Corporation. “Our endocrine
business unit execution has resulted in Afrezza net revenue growth
of 21% vs. the first quarter 2021 and we continue to add sites and
patients into our Afrezza pediatric trial, INHALE-1.”
Total revenues were $12.0 million for the first
quarter of 2022, reflecting Afrezza net revenue of $9.8 million and
collaborations and services revenue of $2.2 million. Afrezza net
revenue increased 21% compared to $8.1 million in the first quarter
of 2021 as a result of wholesaler inventory ordering patterns for
the first quarter of 2021, which was adversely impacted as
wholesalers decreased inventory levels, plus price, which included
more favorable gross-to-net deductions. Collaborations and services
revenue decreased $7.2 million compared to the first quarter of
2021 primarily due to the completion of the R&D Services
associated with our collaboration with United Therapeutics (“UT”).
In August 2021, we entered into a commercial supply agreement
(“CSA”) with UT. Revenue associated with the CSA is deferred as of
March 31, 2022 and will be recognized over the period when
commercial product is sold to UT. The deferred revenue balance
associated with the CSA increased by $7.1 million in the first
quarter to $25.7 million as of March 31, 2022.
Afrezza gross profit for the first quarter of
2022 was $7.5 million compared to $3.8 million in the same period
of 2021, an increase of $3.8 million, or 99%, which was driven by
an increase in Afrezza sales and a decrease in cost of goods sold.
The Afrezza cost of goods sold decreased by $2.0 million, or 47%,
compared to the same period in 2021, primarily as a result of the
absorption of manufacturing-related costs due to the manufacturing
of a second product. Afrezza gross margin in the first quarter of
2022 was 77% compared to 47% for the same period in 2021.
Cost of revenue – collaborations and services
increased by $5.4 million in the first quarter of 2022 compared to
the same period in 2021 primarily due to an increase in costs of
manufacturing activities in preparation for supplying commercial
product to UT.
Research and development expenses for the first
quarter of 2022 were $3.5 million compared to $2.4 million for the
first quarter of 2021. This $1.1 million increase was mainly
related to costs incurred for research and development activities
for our product pipeline, including a phase 1 clinical trial for
inhaled clofazimine.
Selling, general and administrative expenses for
the first quarter of 2022 were $20.7 million compared to $17.4
million for the first quarter of 2021. This $3.3 million increase
was primarily attributable to an enhanced primary care
physician-focused promotional campaign that began in the fourth
quarter of 2021, Afrezza territory restructuring costs, as well as
promotional and patient support services expenses to support
Afrezza sales growth.
For the first quarter of 2022, the gain on
foreign currency translation (for insulin purchase commitments
denominated in Euros) was $2.0 million compared to $3.8 million for
the first quarter of 2021. The fluctuation was due to a change in
the U.S. dollar to Euro foreign currency exchange rate.
Interest expense on financing liability was $2.4
million for the first quarter of 2022 and represented interest
incurred on the sale lease-back transaction for our manufacturing
facility in Danbury, CT.
Interest expense on debt for the first quarter
of 2022 was $2.7 million compared to $6.5 million for the first
quarter of 2021. This decrease of $3.7 million was primarily due to
a milestone payment obligation that was achieved during the first
quarter of 2021, partially offset by an increase in interest
expense related to our senior convertible notes.
The net loss for the first quarter of 2022 was
$26.0 million, or $0.10 per share, compared to $12.9 million in the
first quarter of 2021, or $0.05 per share. The $13.1 million
increase in the net loss was primarily due to a decrease in
revenues from collaboration and services and an increase in the
cost of revenue for collaborations and services. Revenue associated
with the CSA is deferred as of March 31, 2022 and will be
recognized over the period when commercial product is sold to UT.
The increase in cost of revenue for collaborations and services was
primarily due to an increase in costs of manufacturing activities
in preparation for supplying commercial product to UT.
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 Corporation
MannKind Corporation (Nasdaq: MNKD) focuses on
the development and commercialization of inhaled therapeutic
products for patients with endocrine and orphan lung diseases.
MannKind is currently commercializing Afrezza® (insulin human)
Inhalation Powder, the Company’s first FDA-approved product and the
only inhaled ultra rapid-acting mealtime insulin in the United
States, where it is available by prescription from pharmacies
nationwide. Afrezza is also available by prescription in Brazil,
where it is commercialized by the Company’s partner, Biomm SA.
MannKind was established in 1991, and is located in Danbury, Conn.,
and Westlake Village, Calif. The Company also employs field sales
and medical representatives across the U.S. Please visit
mannkindcorp.com to learn more.
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 expected PDUFA date for Tyvaso
DPI and our ability to support United Therapeutics in its planned
commercial launch of Tyvaso DPI. 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: the FDA may not complete its review of the NDA for Tyvaso DPI
on the timeframe expected for various reasons, including due to
disruptions that may be caused by personnel shortages, citizen
petitions and the COVID-19 pandemic; the FDA may determine not to
approve Tyvaso DPI; and if we fail as an effective manufacturing
organization, we may be unable to support commercialization of
Tyvaso DPI, if approved. These and other are 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, 2021, filed
with the SEC on February 24, 2022, and in its Quarterly Report on
Form 10-Q for the quarter ended March 31, 2022, 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 an investigational combination
product that is not approved for any use in any country. The Tyvaso
DPI tradename is pending final FDA review. TYVASO DPI is a
trademark of United Therapeutics Corporation.
AFREZZA is a registered trademark of MannKind
Corporation.
MannKind Contact:Rose Alinaya, Investor
Relations(818) 661-5000
MANNKIND CORPORATION AND
SUBSIDIARY CONDENSED CONSOLIDATED
BALANCE SHEETS (In thousands, except share and per
share data)
|
March 31, 2022 |
|
December 31, 2021 |
ASSETS |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
67,243 |
|
|
$ |
124,184 |
|
Short-term investments |
|
95,203 |
|
|
|
79,932 |
|
Accounts receivable, net |
|
9,823 |
|
|
|
4,739 |
|
Inventory |
|
8,044 |
|
|
|
7,152 |
|
Prepaid expenses and other current assets |
|
3,952 |
|
|
|
3,482 |
|
Total current assets |
|
184,265 |
|
|
|
219,489 |
|
Property and equipment, net |
|
41,453 |
|
|
|
36,612 |
|
Long-term investments |
|
70,542 |
|
|
|
56,619 |
|
Other assets |
|
12,058 |
|
|
|
8,441 |
|
Total assets |
$ |
308,318 |
|
|
$ |
321,161 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' DEFICIT |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
$ |
8,702 |
|
|
$ |
6,956 |
|
Accrued expenses and other current liabilities |
|
27,131 |
|
|
|
27,419 |
|
Financing liability — current |
|
9,410 |
|
|
|
6,977 |
|
Deferred revenue — current |
|
1,307 |
|
|
|
827 |
|
Recognized loss on purchase commitments — current |
|
6,944 |
|
|
|
6,170 |
|
Total current liabilities |
|
53,494 |
|
|
|
48,349 |
|
Senior convertible notes |
|
224,307 |
|
|
|
223,944 |
|
Midcap credit facility |
|
38,939 |
|
|
|
38,833 |
|
Promissory notes |
|
18,425 |
|
|
|
18,425 |
|
Accrued interest — promissory
notes |
|
520 |
|
|
|
404 |
|
Financing liability — long
term |
|
93,463 |
|
|
|
93,525 |
|
Recognized loss on purchase
commitments — long term |
|
72,400 |
|
|
|
76,659 |
|
Operating lease liability |
|
826 |
|
|
|
1,040 |
|
Deferred revenue — long term |
|
26,116 |
|
|
|
19,543 |
|
Milestone rights liability |
|
4,838 |
|
|
|
4,838 |
|
Deposits from customer |
|
7,054 |
|
|
|
4,950 |
|
Total liabilities |
|
540,382 |
|
|
|
530,510 |
|
Stockholders' deficit: |
|
|
|
|
|
|
|
Undesignated preferred stock,
$0.01 par value — 10,000,000 shares authorized; no shares issued or
outstanding as of March 31, 2022 and December 31, 2021 |
|
— |
|
|
|
— |
|
Common stock, $0.01 par value -
400,000,000 shares authorized, 252,413,434 and 251,477,562 shares
issued and outstanding at March 31, 2022 and December 31, 2021,
respectively |
|
2,524 |
|
|
|
2,515 |
|
Additional paid-in capital |
|
2,922,555 |
|
|
|
2,918,205 |
|
Accumulated other comprehensive
loss |
|
(1,076 |
) |
|
|
— |
|
Accumulated deficit |
|
(3,156,067 |
) |
|
|
(3,130,069 |
) |
Total stockholders' deficit |
|
(232,064 |
) |
|
|
(209,349 |
) |
Total liabilities and
stockholders' deficit |
$ |
308,318 |
|
|
$ |
321,161 |
|
|
MANNKIND CORPORATION AND
SUBSIDIARY CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS (In thousands, except per
share data)
|
Three Months EndedMarch 31, |
|
|
2022 |
|
2021 |
Revenues: |
|
|
|
|
|
|
|
Net revenue — commercial product sales |
$ |
9,826 |
|
|
$ |
8,099 |
|
Revenue — collaborations and services |
|
2,166 |
|
|
|
9,337 |
|
Total revenues |
|
11,992 |
|
|
|
17,436 |
|
Expenses: |
|
|
|
|
|
|
|
Cost of goods sold |
|
2,284 |
|
|
|
4,315 |
|
Cost of revenue — collaborations and services |
|
8,714 |
|
|
|
3,295 |
|
Research and development |
|
3,536 |
|
|
|
2,442 |
|
Selling, general and administrative |
|
20,697 |
|
|
|
17,413 |
|
Gain on foreign currency translation |
|
(1,983 |
) |
|
|
(3,838 |
) |
Total expenses |
|
33,248 |
|
|
|
23,627 |
|
Loss from operations |
|
(21,256 |
) |
|
|
(6,191 |
) |
Other (expense) income: |
|
|
|
|
|
|
|
Interest income, net |
|
377 |
|
|
|
3 |
|
Interest expense on financing liability |
|
(2,371 |
) |
|
|
— |
|
Interest expense on notes |
|
(2,748 |
) |
|
|
(6,452 |
) |
Other expense |
|
— |
|
|
|
(276 |
) |
Total other expense |
|
(4,742 |
) |
|
|
(6,725 |
) |
Loss before provision for income
taxes |
|
(25,998 |
) |
|
|
(12,916 |
) |
Provision for income taxes |
|
— |
|
|
|
— |
|
Net loss |
$ |
(25,998 |
) |
|
$ |
(12,916 |
) |
Net loss per share - basic and
diluted |
$ |
(0.10 |
) |
|
$ |
(0.05 |
) |
Shares used to compute net loss
per share - basic and diluted |
|
251,887 |
|
|
|
246,631 |
|
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