Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a clinical-stage
biopharmaceutical company dedicated to the research, development
and commercialization of innovative therapies for rare diseases of
the eye, today reported financial results for the third quarter
ended September 30, 2022 and provided a corporate update.
“We continue to advance our proprietary mesenchymal stem cell
secretome (MSC-S) platform and expect to submit an investigational
new drug (IND) application with the U.S. Food and Drug
Administration (FDA) during the fourth quarter of 2022 for KPI-012
for the treatment of PCED,” said Mark Iwicki, Chief Executive
Officer and Chairman of Kala. “Pending IND clearance, we plan to
initiate our Phase 2/3 clinical trial in the fourth quarter of
2022, marking a significant step toward our goal of delivering the
promise of MSC-S-based therapies to people living with rare and
severe ocular diseases.”
PCED is a clinically burdensome condition with high unmet needs.
It affects approximately 100,000 people in the United States each
year and, if left untreated, can lead to infection, corneal
ulceration or perforation, scarring, opacification and significant
vision loss. Based on its multifactorial mechanism of action and
preclinical and clinical data generated to-date, Kala believes
KPI-012 may represent a significant advancement in the treatment of
PCED and could become the first approved treatment for PCED across
all its various etiologies. Kala also plans to explore the
potential of its MSC-S platform for other rare corneal disease
indications where it believes its secretome-based approach could
deliver benefit.
Third Quarter and Recent Business
Highlights:
Development-Stage Pipeline:
KPI-012 is a human mesenchymal stem cell secretome, which
contains numerous human-derived biofacters, such as growth factors,
protease inhibitors, matrix proteins and neurotrophic factors that
can potentially correct the impaired corneal healing that is an
underlying etiology of multiple severe ocular diseases. Subject to
submission and clearance of an IND, Kala plans to initiate a Phase
2/3 clinical trial of KPI-012 in PCED patients during the fourth
quarter of 2022 with topline results expected in the first quarter
2024. The Phase 2/3 trial is designed to evaluate the efficacy and
safety of two doses of KPI-012 in PCED patients with a broad range
of underlying etiologies.
Kala has received Orphan Drug Designation from the FDA for
KPI-012 for the treatment of PCED.
In addition, Kala is evaluating the potential of KPI-012 to
treat other rare anterior segment diseases as follow-on
indications, such as Partial Limbal Stem Cell Deficiency and ocular
manifestations of moderate-to-severe Sjögren’s. Kala also plans to
initiate preclinical studies for KPI-014, the Company’s program
evaluating the utility of its MSC-S platform for retinal
degenerative diseases such as Retinitis Pigmentosa and Stargardt
Disease, with the goal of selecting a retinal indication for
development in the second half of 2023.
Corporate Updates:
In November 2022, Kala announced the appointment of Marjan
Farid, M.D., to its Board of Directors. Dr. Farid, who is currently
Professor of Clinical Ophthalmology, Director of Cornea, Refractive
& Cataract Surgery, and Vice Chair of Ophthalmic Faculty at the
Gavin Herbert Eye Institute, University of California Irvine (UCI),
founded the Severe Ocular Surface Disease Center at UCI and is an
industry leader in the care and treatment of corneal diseases. On
October 20, 2022, Kala effected a 1-for-50 reverse stock split of
its shares of common stock either issued and outstanding or held by
the Company as treasury stock. As a result of the reverse stock
split, every 50 shares of issued and outstanding common stock were
automatically combined into one issued and outstanding share of
common stock, without any change in the par value per share. No
fractional shares were issued as a result of the reverse stock
split. Any fractional shares that would otherwise have resulted
from the reverse stock split were rounded up to the next whole
number.
Financial Results:
The financial results below contain both GAAP and non-GAAP
financial measures. The non-GAAP financial measures exclude
stock-based compensation expense, non-cash interest expense,
depreciation and amortization, transaction costs related to
the Alcon transaction, gain or loss on fair value remeasurement of
deferred purchase and contingent consideration, gain on sale of the
commercial business, loss on extinguishment of debt and other
non-cash expenses. See “Non-GAAP Financial Measures” below; for a
full reconciliation of Kala’s GAAP to non-GAAP financial measures,
please refer to the tables at the end of this press release.
- Cash Position: As of September 30, 2022, Kala
had cash and cash equivalents of $52.4 million, compared to $44.6
million of cash and cash equivalents as of June 30, 2022. This
increase reflects the net proceeds received from the sale of Kala’s
commercial portfolio and related intellectual property assets to
Alcon Inc., which closed in July 2022, partially offset by cash
used in operations. Included in Kala’s cash and cash equivalents of
$52.4 million as of September 30, 2022 is $2.8 million of cash
collected on behalf of Alcon from the sales of EYSUVIS and INVELTYS
following the close of the transaction. Based on its current plans,
Kala anticipates that its cash resources as of September 30, 2022
will enable it to fund its operations into the second quarter of
2024. Kala continues to anticipate approximately a 50% reduction in
non-GAAP operating expenses in the second half of 2022 as compared
to the first half of 2022 and a 60-70% reduction in non-GAAP total
operating expenses for the full year 2023 compared to the full year
2021.
Third Quarter 2022 Financial Results:
- Net Product Revenues: For the quarter ended
September 30, 2022, Kala reported net product revenues of $0.4
million, representing approximately one week of net product
revenues from sales of EYSUVIS and INVELTYS. Kala recognized net
product revenues from EYSUVIS and INVELTYS until it completed the
sale of its commercial portfolio to Alcon on July 8, 2022. For the
quarter ended September 30, 2021, Kala reported net product
revenues of $3.1 million.
- Cost of Product Revenues: For the quarter
ended September 30, 2022, cost of product revenues was less than
$0.1 million representing approximately one week of cost of product
revenues as Kala completed the sale of its commercial portfolio to
Alcon on July 8, 2022, compared to cost of product revenues of $0.9
million for the same period in 2021. Non-GAAP cost of product
revenues were less than $0.1 million for the quarter ended
September 30, 2022, compared to $0.9 million for the same period in
2021.
- SG&A Expenses: For the quarter ended
September 30, 2022, selling, general and administrative (SG&A)
expenses were $9.5 million, compared to $25.3 million for the same
period in 2021. The decrease was primarily due to the sale of
Kala’s commercial portfolio to Alcon, which closed on July 8, 2022.
Non-GAAP SG&A expenses were $8.4 million for the quarter ended
September 30, 2022, compared to $22.1 million for the same period
in 2021.
- R&D Expenses: For the quarter ended
September 30, 2022, research and development (R&D) expenses
were $5.4 million, compared to $2.9 million for the same period in
2021. The increase was primarily due to development costs for
KPI-012, including pre-clinical studies to support the planned IND
submission. Non-GAAP R&D expenses were $5.1 million for the
quarter ended September 30, 2022, compared to $2.0 million for the
same period in 2021.
- Gain on Fair Value Remeasurement of Deferred Purchase
Consideration: For the quarter ended September 30, 2022,
the gain on fair value remeasurement of deferred purchase
consideration, in connection with the acquisition of Combangio,
Inc. (Combangio) in November 2021, was less than $0.1 million.
There was no gain or loss on fair value remeasurement of deferred
purchase consideration for the same period in 2021. Non-GAAP
operating loss and non-GAAP net loss exclude the gain on fair value
remeasurement of deferred purchase consideration.
- Loss on Fair Value Remeasurement of Contingent
Consideration: For the quarter ended September 30, 2022,
the loss on fair value remeasurement of contingent consideration,
in connection with the Combangio acquisition, was $0.1 million.
There was no gain or loss on fair value remeasurement of contingent
consideration for the same period in 2021. Non-GAAP operating loss
and non-GAAP net loss exclude the gain on fair value remeasurement
of contingent consideration.
- Operating Loss: For the quarter
ended September 30, 2022, loss from operations was $14.6
million, compared to $26.1 million for the same period in
2021. Non-GAAP operating loss was $13.1 million for the
quarter ended September 30, 2022, compared to $21.9
million for the same period in 2021.
- Loss on Extinguishment of Debt: For the
quarter ended September 30, 2022, Kala reported a loss on
extinguishment of debt of $2.6 million as a result of a partial
prepayment of outstanding principal and related fees on the
Company’s loan agreement in connection with the closing of the sale
of its commercial business. There was no loss on extinguishment of
debt for the same period in 2021.
- Gain on Sale of Commercial Business: For the
quarter ended September 20, 2022, Kala reported a gain on the sale
of its commercial business to Alcon of $47.0 million. There was no
gain on sale of commercial business for the same period in
2021.
- Net Income/Loss: For the quarter ended
September 30, 2022, Kala reported net income of $29.1 million, or a
basic net income per share of $19.39 and $19.25 per share on a
fully diluted basis, compared to a net loss of $28.1 million, or
$21.41 per share on a basic and diluted basis, for the same period
in 2021. Non-GAAP net loss was $13.5 million for the quarter ended
September 30, 2022, compared to $23.5 million for the same period
in 2021. The weighted average number of shares used to calculate
net income/loss per share was 1.5 million for the quarter ended
September 30, 2022, and 1.3 million for the quarter ended September
30, 2021. On October 20, 2022, Kala effected a reverse stock split
of its outstanding common stock at a ratio of 1 post-split share
for every 50 pre-split shares. Proportional adjustments were also
made to the number of shares of Kala’s common stock issuable upon
exercise or conversion of Kala’s equity awards and warrants, as
well as the applicable exercise price. The weighted average number
of shares used to calculate net income/loss has been retroactively
adjusted for all periods presented in this press release to reflect
the reverse stock split.
Nine Months ended September 30, 2022 Financial
Results:
- Net Product Revenues: For the nine months
ended September 30, 2022, Kala reported net product revenues of
$3.9 million, which is reflective of the closing of the sale of
Kala’s commercial portfolio to Alcon on July 8, 2022. For the same
period in 2021, Kala reported net product revenues of $9.4
million.
- Cost of Product Revenues: For the nine months
ended September 30, 2022, cost of product revenues was $2.6
million, compared to $2.7 million for the same period in 2021.
Non-GAAP cost of product revenues was $2.4 million for the nine
months ended September 30, 2022, compared to $2.5 million for the
same period in 2021.
- SG&A Expenses: For the nine months ended
September 30, 2022, SG&A expenses were $59.2 million, compared
to $81.0 million for the same period in 2021. The decrease was
primarily due to the sale of Kala’s commercial portfolio to Alcon,
which closed on July 8, 2022. Non-GAAP SG&A expenses were $53.4
million for the nine months ended September 30, 2022, compared to
$70.1 million for the same period in 2021.
- R&D Expenses: For the nine months ended
September 30, 2022, R&D expenses were $14.3 million, compared
to $9.1 million for the same period in 2021. The increase was
primarily due to development costs for KPI-012, including
pre-clinical studies to support the planned IND submission.
Non-GAAP R&D expenses were $13.1 million for the nine months
ended September 30, 2022, compared to $6.1 million for the same
period in 2021.
- Loss on Fair Value Remeasurement of Deferred Purchase
Consideration: For the nine months ended September 30,
2022, the loss on fair value remeasurement of deferred purchase
consideration, in connection with the acquisition of Combangio, was
$0.2 million. There was no gain or loss on fair value remeasurement
of deferred purchase consideration for the same period in 2021.
Non-GAAP operating loss and non-GAAP net loss exclude the loss on
fair value remeasurement of deferred purchase consideration.
- Gain on Fair Value Remeasurement of Contingent
Consideration: For the nine months ended September 30,
2022, the gain on fair value remeasurement of contingent
consideration, in connection with the Combangio acquisition, was
$1.0 million. There was no gain or loss on fair value remeasurement
of contingent consideration for the same period in 2021. Non-GAAP
operating loss and non-GAAP net loss exclude the gain on fair value
remeasurement of contingent consideration.
- Operating Loss: For the nine months
ended September 30, 2022, loss from operations was $71.5
million, compared to $83.4 million for the same period in
2021. Non-GAAP operating loss was $64.9 million for the
nine months ended September 30, 2022, compared to $69.3
million for the same period in 2021.
- Loss on Extinguishment of Debt: For the nine
months ended September 30, 2022, Kala reported a loss on
extinguishment of debt of $2.6 million as a result of a partial
prepayment of outstanding principal and related fees on the
Company’s loan agreement in connection with the closing of the sale
of its commercial business. There was no loss on extinguishment of
debt for the same period in 2021.
- Gain on Sale of Commercial Business: For the
nine months ended September 20, 2022, Kala reported a gain on the
sale of its commercial business to Alcon of $47.0 million. There
was no gain on sale of commercial business for the same period in
2021.
- Net Loss: For the nine months ended September
30, 2022, net loss was $32.0 million, or $21.46 per share, compared
to a net loss of $95.0 million, or $73.80 per share, for the same
period in 2021. Non-GAAP net loss was $68.7 million for the nine
months ended September 30, 2022, compared to $74.5 million for the
same period in 2021. The weighted average number of shares used to
calculate net loss per share was 1.5 million for the nine months
ended September 30, 2022, and 1.3 million for the nine months ended
September 30, 2021. October 20, 2022, Kala effected a reverse stock
split of its outstanding common stock at a ratio of 1 post-split
share for every 50 pre-split shares. Proportional adjustments were
also made to the number of shares of Kala’s common stock issuable
upon exercise or conversion of Kala’s equity awards and warrants,
as well as the applicable exercise price. The weighted average
number of shares used to calculate net income/loss has been
retroactively adjusted for all periods presented in this press
release to reflect the reverse stock split.
Non-GAAP Financial Measures:
In this press release, the financial results of Kala are
provided in accordance with accounting principles generally
accepted in the United States (GAAP) and using certain non-GAAP
financial measures. The items included in GAAP presentations but
excluded for purposes of determining non-GAAP financial measures
for the periods presented in this press release are stock-based
compensation expense, non-cash interest expense, depreciation and
amortization, transaction costs related to the Alcon transaction,
acquired in-process research and development expense, gain or loss
on fair value remeasurement of deferred purchase consideration and
contingent consideration, gain on fair value remeasurement of
deferred purchase consideration, gain on sale of the commercial
business, loss on extinguishment of debt and other non-cash
expenses, transaction costs related to the acquisition of
Combangio, and the impact of the termination of the lease for the
Company’s former corporate headquarters. Management believes this
non-GAAP information is useful for investors, taken in conjunction
with Kala’s GAAP financial statements, because it provides greater
transparency and period-over-period comparability with respect to
Kala’s operating performance. These measures are also used by
management to assess the performance of the business. Investors
should consider these non-GAAP measures only as a supplement to,
not as a substitute for, or as superior to, measures of financial
performance prepared in accordance with GAAP. In addition, these
non-GAAP financial measures are unlikely to be comparable with
non-GAAP information provided by other companies. A quantitative
reconciliation of projected total non-GAAP operating expenses to
total GAAP operating expenses is not available without unreasonable
effort primarily due to Kala’s inability to predict with reasonable
certainty the amount of future stock-based compensation expense.
For a reconciliation of these non-GAAP financial measures to the
most comparable GAAP measures, please refer to the table at the end
of this press release.
About Kala Pharmaceuticals, Inc.
Kala is a clinical-stage biopharmaceutical company dedicated to
the research, development and commercialization of innovative
therapies for rare diseases of the eye. Kala’s biologics-based
investigational therapies utilize Kala’s proprietary Mesenchymal
Stem Cell Secretome (MSC-S) platform. Kala’s lead product
candidate, KPI-012, is in clinical development for the treatment of
persistent corneal epithelial defect (PCED), a rare disease of
impaired corneal healing, which has received orphan drug
designation from the U.S. Food and Drug Administration. Kala is
also targeting the potential development of KPI-012 for the
treatment of Partial Limbal Stem Cell Deficiency and ocular
manifestations of moderate-to-severe Sjögren's and plans to
initiate preclinical studies to evaluate the utility of its MSC-S
platform for retinal degenerative diseases, such as Retinitis
Pigmentosa and Stargardt Disease. For more information on Kala,
please visit www.kalarx.com.
Forward Looking Statements:
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that involve substantial risks and uncertainties. Any statements in
this press release about Kala’s future expectations, plans and
prospects, including but not limited to statements about Kala’s
expectations with respect to potential advantages of KPI-012 and
its MSC-S platform; the future development or commercialization of
KPI-012; plans to submit regulatory filings; conduct and timelines
of preclinical studies and clinical trials; the clinical utility of
KPI-012 for PCED; plans to pursue research and development of
KPI-012 and its MSC-S platform for other indications; Kala’s
ability to realize potential milestones payments under the
transaction with Alcon; Kala’s estimates regarding its projected
reduction in non-GAAP operating expenses; the sufficiency of Kala’s
existing cash resources, and other statements containing the words
“anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,”
“plan,” “predict,” “project,” “target,” “potential,” “likely,”
“will,” “would,” “could,” “should,” “continue,” and similar
expressions constitute forward-looking statements. Actual results
may differ materially from those indicated by such forward-looking
statements as a result of various important factors, including: the
effect that the reverse stock split may have on the price of Kala’s
common stock; Kala’s ability to realize any milestone payments from
Alcon Inc.; the impact of extraordinary external events, such as
the current pandemic health event resulting from the novel
coronavirus (COVID-19), and their collateral consequences; Kala’s
ability to maintain its listing on the Nasdaq Global Select Market;
Kala’s ability to comply with the covenants under its outstanding
loan agreement; the uncertainties inherent in the initiation and
conduct of preclinical studies and clinical trials; uncertainties
regarding availability and timing of data from clinical trials;
whether results of early clinical trials or trials in different
disease indications will be indicative of the results of ongoing or
future trials; whether results of the Phase 1b clinical trial of
KPI-012 will be indicative of results for any future clinical
trials and studies of KPI-012; uncertainties associated with
regulatory review of clinical trials and applications for marketing
approvals; Kala’s ability to retain and hire key personnel; the
sufficiency of cash resources and need for additional financing and
other important factors, any of which could cause the Kala’s actual
results to differ from those contained in the forward-looking
statements, discussed in the “Risk Factors” section of Kala’s
Annual Report on Form 10-K, most recently filed Quarterly Report on
Form 10-Q and other filings Kala makes with the Securities and
Exchange Commission. These forward-looking statements represent
Kala’s views as of the date of this press release and should not be
relied upon as representing Kala’s views as of any date subsequent
to the date hereof. Kala does not assume any obligation to update
any forward-looking statements, whether as a result of new
information, future events or otherwise, except as required by
law.
Investor Contact:
Hannah Deresiewiczhannah.deresiewicz@sternir.com
212-362-1200
Financial Tables
Kala Pharmaceuticals, Inc. |
Balance Sheet Data |
(in thousands) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2022 |
|
|
|
2021 |
Cash and cash equivalents |
|
|
$ |
52,393 |
|
|
|
$ |
92,136 |
Total
assets |
|
|
|
85,698 |
|
|
|
|
139,427 |
Working capital (1) |
|
|
|
44,431 |
|
|
|
|
86,944 |
Longterm debt, net of
discounts |
|
|
|
42,642 |
|
|
|
|
78,929 |
Other longterm
liabilities |
|
|
|
3,783 |
|
|
|
|
6,272 |
Total
stockholders’ (deficit) equity |
|
|
|
(968 |
) |
|
|
|
16,804 |
|
|
|
|
|
|
|
|
|
(1) The Company
defines working capital as current assets less current liabilities.
See the Company's consolidated financial statements for further
information regarding its current assets and current
liabilities. |
Kala Pharmaceuticals, Inc. |
Consolidated Statement of Operations |
(In thousands, except share and per share
data) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
|
September 30, |
|
September 30, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues, net |
|
|
$ |
420 |
|
|
$ |
3,067 |
|
|
$ |
3,892 |
|
|
$ |
9,384 |
|
Costs
and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenues |
|
|
|
11 |
|
|
|
908 |
|
|
|
2,560 |
|
|
|
2,679 |
|
Selling, general and administrative |
|
|
|
9,549 |
|
|
|
25,349 |
|
|
|
59,204 |
|
|
|
81,034 |
|
Research and development |
|
|
|
5,391 |
|
|
|
2,881 |
|
|
|
14,330 |
|
|
|
9,101 |
|
(Gain) loss on fair value remeasurement of deferred purchase
consideration |
|
(57 |
) |
|
|
— |
|
|
|
205 |
|
|
|
— |
|
Loss (gain) on fair value remeasurement of contingent
consideration |
|
|
|
95 |
|
|
|
— |
|
|
|
(952 |
) |
|
|
— |
|
Total operating expenses |
|
|
|
14,989 |
|
|
|
29,138 |
|
|
|
75,347 |
|
|
|
92,814 |
|
Loss
from operations |
|
|
|
(14,569 |
) |
|
|
(26,071 |
) |
|
|
(71,455 |
) |
|
|
(83,430 |
) |
Other
income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
|
234 |
|
|
|
16 |
|
|
|
310 |
|
|
|
92 |
|
Interest expense |
|
|
|
(1,447 |
) |
|
|
(2,072 |
) |
|
|
(5,689 |
) |
|
|
(6,304 |
) |
Loss on extinguishment of debt |
|
|
|
(2,583 |
) |
|
|
— |
|
|
|
(2,583 |
) |
|
|
(5,395 |
) |
Gain on sale of Commercial Business |
|
|
|
46,995 |
|
|
|
— |
|
|
|
46,995 |
|
|
|
— |
|
Other income (expense), net |
|
|
|
443 |
|
|
|
— |
|
|
|
443 |
|
|
|
— |
|
Net income (loss) |
|
|
$ |
29,073 |
|
|
$ |
(28,127 |
) |
|
$ |
(31,979 |
) |
|
$ |
(95,037 |
) |
Net
income (loss) per share attributable to common
stockholders—basic |
|
|
$ |
19.39 |
|
|
$ |
(21.41 |
) |
|
$ |
(21.46 |
) |
|
$ |
(73.80 |
) |
Net
income (loss) per share attributable to common
stockholders—diluted |
|
|
$ |
19.25 |
|
|
$ |
(21.41 |
) |
|
$ |
(21.46 |
) |
|
$ |
(73.80 |
) |
Weighted average shares outstanding—basic |
|
|
|
1,499,001 |
|
|
|
1,313,466 |
|
|
|
1,490,159 |
|
|
|
1,287,772 |
|
Weighted average shares outstanding—diluted |
|
|
|
1,510,421 |
|
|
|
1,313,466 |
|
|
|
1,490,159 |
|
|
|
1,287,772 |
|
Kala Pharmaceuticals, Inc. |
Reconciliation of GAAP to non-GAAP Financial
Measures |
(In thousands) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2022 |
|
|
2021 |
|
|
|
2022 |
|
|
2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) (GAAP) |
|
|
$ |
29,073 |
|
|
$ |
(28,127 |
) |
|
|
$ |
(31,979 |
) |
|
$ |
(95,037 |
) |
Add-back: stock-based
compensation expense |
|
|
|
1,327 |
|
|
|
3,928 |
|
|
|
|
6,048 |
|
|
|
13,340 |
|
Add-back: non-cash
interest |
|
|
|
258 |
|
|
|
435 |
|
|
|
|
1,130 |
|
|
|
1,080 |
|
Add-back: depreciation and
amortization |
|
|
|
151 |
|
|
|
259 |
|
|
|
|
457 |
|
|
|
763 |
|
Add-back: transaction costs
related to the Alcon transaction |
|
|
|
— |
|
|
|
— |
|
|
|
|
758 |
|
|
|
— |
|
Add (gain) loss on fair value
remeasurement of deferred purchase consideration |
|
|
|
(57 |
) |
|
|
— |
|
|
|
|
205 |
|
|
|
— |
|
Add: gain on fair value
remeasurement of contingent consideration |
|
|
|
95 |
|
|
|
— |
|
|
|
|
(952 |
) |
|
|
— |
|
Add-back: gain on sale of
Commercial Business |
|
|
|
(46,955 |
) |
|
|
— |
|
|
|
|
(46,955 |
) |
|
|
— |
|
Add-back: loss on debt
extinguishment |
|
|
|
2,583 |
|
|
|
— |
|
|
|
|
2,583 |
|
|
|
5,395 |
|
Add-back: other expense |
|
|
|
94 |
|
|
|
— |
|
|
|
|
94 |
|
|
|
— |
|
non-GAAP net loss |
|
|
$ |
(13,471 |
) |
|
$ |
(23,505 |
) |
|
|
$ |
(68,651 |
) |
|
$ |
(74,459 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenues
(GAAP) |
|
|
$ |
11 |
|
|
$ |
908 |
|
|
|
$ |
2,560 |
|
|
$ |
2,679 |
|
Less: stock-based compensation
expense |
|
|
|
4 |
|
|
|
38 |
|
|
|
|
166 |
|
|
|
109 |
|
Less: depreciation and
amortization |
|
|
|
7 |
|
|
|
13 |
|
|
|
|
33 |
|
|
|
39 |
|
non-GAAP cost of product
revenues |
|
|
$ |
— |
|
|
$ |
857 |
|
|
|
$ |
2,361 |
|
|
$ |
2,531 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative expenses (GAAP) |
|
|
$ |
9,549 |
|
|
$ |
25,349 |
|
|
|
$ |
59,204 |
|
|
$ |
81,034 |
|
Less: stock-based compensation
expense |
|
|
|
1,085 |
|
|
|
3,021 |
|
|
|
|
4,797 |
|
|
|
10,410 |
|
Less: depreciation and
amortization |
|
|
|
101 |
|
|
|
185 |
|
|
|
|
273 |
|
|
|
553 |
|
Less: transaction costs
related to the Alcon transaction |
|
|
|
— |
|
|
|
— |
|
|
|
|
758 |
|
|
|
— |
|
non-GAAP selling, general and
administrative expenses |
|
|
$ |
8,363 |
|
|
$ |
22,143 |
|
|
|
$ |
53,376 |
|
|
$ |
70,071 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
expenses (GAAP) |
|
|
$ |
5,391 |
|
|
$ |
2,881 |
|
|
|
$ |
14,330 |
|
|
$ |
9,101 |
|
Less: stock-based compensation
expense |
|
|
|
238 |
|
|
|
869 |
|
|
|
|
1,085 |
|
|
|
2,821 |
|
Less: depreciation and
amortization |
|
|
|
43 |
|
|
|
61 |
|
|
|
|
151 |
|
|
|
171 |
|
non-GAAP research and
development expenses |
|
|
$ |
5,110 |
|
|
$ |
1,951 |
|
|
|
$ |
13,094 |
|
|
$ |
6,109 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Gain) loss on fair value
remeasurement of deferred purchase consideration |
|
|
$ |
(57 |
) |
|
$ |
— |
|
|
|
$ |
205 |
|
|
$ |
— |
|
Less: (gain) loss on fair
value remeasurement of deferred purchase consideration |
|
|
|
(57 |
) |
|
|
— |
|
|
|
|
205 |
|
|
|
— |
|
non-GAAP gain or loss on fair
value remeasurement of deferred purchase consideration |
|
|
$ |
— |
|
|
$ |
— |
|
|
|
$ |
— |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss (gain) on fair value
remeasurement of contingent consideration |
|
|
$ |
95 |
|
|
$ |
— |
|
|
|
$ |
(952 |
) |
|
$ |
— |
|
Less: loss (gain) on fair
value remeasurement of contingent consideration |
|
|
|
95 |
|
|
|
— |
|
|
|
|
(952 |
) |
|
|
— |
|
non-GAAP gain or loss on fair
value remeasurement of contingent consideration |
|
|
$ |
— |
|
|
$ |
— |
|
|
|
$ |
— |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating loss
(GAAP) |
|
|
$ |
(14,569 |
) |
|
$ |
(26,071 |
) |
|
|
$ |
(71,455 |
) |
|
$ |
(83,430 |
) |
Add-back: stock-based
compensation expense |
|
|
|
1,327 |
|
|
|
3,928 |
|
|
|
|
6,048 |
|
|
|
13,340 |
|
Add-back: depreciation and
amortization |
|
|
|
151 |
|
|
|
259 |
|
|
|
|
457 |
|
|
|
763 |
|
Add-back: transaction costs
related to the Alcon transaction |
|
|
|
— |
|
|
|
— |
|
|
|
|
758 |
|
|
|
— |
|
Add: (gain) loss on fair value
remeasurement of deferred purchase consideration |
|
|
|
(57 |
) |
|
|
— |
|
|
|
|
205 |
|
|
|
— |
|
Add: gain on fair value
remeasurement of contingent consideration |
|
|
|
95 |
|
|
|
— |
|
|
|
|
(952 |
) |
|
|
— |
|
non-GAAP total operating
loss |
|
|
$ |
(13,053 |
) |
|
$ |
(21,884 |
) |
|
|
$ |
(64,939 |
) |
|
$ |
(69,327 |
) |
Kala Pharmaceuticals,
Inc.Reconciliation of GAAP to non-GAAP Financial
Measures(In
thousands)(Unaudited)
|
|
|
|
|
|
|
|
Year EndedDecember 31, 2021 |
|
|
|
|
|
Net loss (GAAP) |
|
|
$ |
142,605 |
|
Add-back: stock-based compensation expense |
|
|
|
16,088 |
|
Add-back: non-cash interest |
|
|
|
1,519 |
|
Add-back: depreciation and amortization |
|
|
|
975 |
|
Add-back: loss on extinguishment of debt |
|
|
|
5,395 |
|
Add-back: acquired in-process research and development |
|
|
|
26,617 |
|
Add-back: gain on fair value remeasurement of deferred purchase
consideration |
|
|
|
(5,805 |
) |
Add-back: gain on fair value remeasurement of contingent
consideration |
|
|
|
— |
|
Add
back: transaction costs related to acquisition of Combangio,
Inc. |
|
|
|
1,179 |
|
Add-back: impact of lease modification |
|
|
|
(2,467 |
) |
non-GAAP net loss |
|
|
$ |
(99,104 |
) |
|
|
|
|
|
Cost
of product revenues (GAAP) |
|
|
$ |
4,097 |
|
Less:
stock-based compensation expense |
|
|
|
169 |
|
Less:
depreciation and amortization |
|
|
|
52 |
|
non-GAAP cost of product revenues |
|
|
$ |
3,876 |
|
|
|
|
|
|
Selling, general and administrative expenses (GAAP) |
|
|
$ |
105,061 |
|
Less:
stock-based compensation expense |
|
|
|
12,774 |
|
Less:
depreciation and amortization |
|
|
|
693 |
|
Less:
transaction costs related to acquisition of Combangio, Inc. |
|
|
|
1,179 |
|
Less:
impact of lease modification |
|
|
|
(1,156 |
) |
non-GAAP selling, general and administrative expenses |
|
|
$ |
91,571 |
|
|
|
|
|
|
Research and development expenses (GAAP) |
|
|
$ |
11,515 |
|
Less:
stock-based compensation expense |
|
|
|
3,145 |
|
Less:
depreciation and amortization |
|
|
|
230 |
|
non-GAAP research and development expenses |
|
|
$ |
8,140 |
|
|
|
|
|
|
Acquired in-process research and development expenses (GAAP) |
|
|
$ |
26,617 |
|
Less:
acquired in-process research and development expenses |
|
|
|
26,617 |
|
non-GAAP acquired in-process research and development expenses |
|
|
$ |
— |
|
|
|
|
|
|
Gain
on fair value remeasurement of deferred purchase consideration |
|
|
$ |
(5,805 |
) |
Less:
gain on fair value remeasurement of deferred purchase
consideration |
|
|
|
(5,805 |
) |
non-GAAP gain on fair value remeasurement of deferred purchase
consideration |
|
|
$ |
— |
|
|
|
|
|
|
Gain
on fair value remeasurement of contingent consideration |
|
|
$ |
— |
|
Less:
gain on fair value remeasurement of contingent consideration |
|
|
|
— |
|
non-GAAP gain on fair value remeasurement of contingent
consideration |
|
|
$ |
— |
|
|
|
|
|
|
Total
operating expenses (GAAP) |
|
|
$ |
141,485 |
|
Less:
stock-based compensation expense |
|
|
|
16,088 |
|
Less:
depreciation and amortization |
|
|
|
975 |
|
Less:
transaction costs related to acquisition of Combangio, Inc. |
|
|
|
1,179 |
|
Less:
impact of lease modification |
|
|
|
(1,156 |
) |
Less:
acquired in-process research and development expenses |
|
|
|
26,617 |
|
Less:
gain on fair value remeasurement of deferred purchase
consideration |
|
|
|
(5,805 |
) |
Less:
gain on fair value remeasurement of contingent consideration |
|
|
|
— |
|
non-GAAP total operating expenses |
|
|
$ |
103,587 |
|
|
|
|
|
|
Total
operating loss (GAAP) |
|
|
$ |
(130,245 |
) |
Add-back: stock-based compensation expense |
|
|
|
16,088 |
|
Add-back: depreciation and amortization |
|
|
|
975 |
|
Add-back: acquired in-process research and development |
|
|
|
26,617 |
|
Add-back:gain on fair value remeasurement of deferred purchase
consideration |
|
|
|
(5,805 |
) |
Add-back: gain on fair value remeasurement of contingent
consideration |
|
|
|
— |
|
Add-back: transaction costs related to acquisition of Combangio,
Inc. |
|
|
|
1,179 |
|
Add-back: impact of lease modification |
|
|
|
(1,156 |
) |
non-GAAP total operating loss |
|
|
$ |
(92,347 |
) |
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