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 second quarter
ended June 30, 2022 and provided a corporate update.
“We continue to make meaningful progress toward our goal of
developing novel medicines that can improve the care and treatment
of eye diseases. In July, we completed the sale of EYSUVIS and
INVELTYS to Alcon Inc., a business with decades of experience
providing market-leading vision care globally, and an ideal
acquirer to expand the reach of these assets,” said Mark Iwicki,
Chief Executive Officer and Chairman of Kala. “Now, we are focusing
our efforts on KPI-012, our mesenchymal stem cell secretome (MSC-S)
for the treatment of rare and severe ocular diseases. In addition
to the clinical development of KPI-012 for PCED, we believe this
product candidate has the potential to treat Partial Limbal Stem
Cell Deficiency and ocular manifestations of moderate-to-severe
Sjögren’s. We also plan to initiate preclinical studies researching
the utility of our MSC-S platform technology for retinal
degenerative diseases, such as Retinitis Pigmentosa and Stargardt
Disease.”
Second Quarter and Recent Business
Highlights:
Development-Stage Pipeline:
KPI-012 is a mesenchymal stem cell secretome, which combines
growth factors, protease inhibitors, matrix proteins and
neurotrophic factors to potentially correct the impaired corneal
healing that is an underlying etiology of multiple severe ocular
diseases. Subject to the filing and clearance of an investigational
new drug application, Kala plans to initiate a Phase 2/3 clinical
trial of KPI-012 in PCED patients in the fourth quarter of 2022. In
addition to PCED, Kala is evaluating the potential of KPI-012 for
the treatment of Partial Limbal Stem Cell Deficiency and ocular
manifestations of moderate-to-severe Sjögren’s, both of which are
areas of significant unmet medical need.
Persistent corneal epithelial defect (PCED) is a persistent
non-healing corneal defect or wound that is refractory to
conventional treatments. If left untreated PCED can lead to
infection, corneal ulceration and/or perforation, scarring,
opacification and significant vision loss. PCED is a disease of
impaired corneal healing and can be the result of numerous
etiologies, including (but not limited to) neurotrophic keratitis,
infectious keratitis, surgical or nonsurgical trauma, and
significant ocular surface diseases of various causes. In PCED, the
normal corneal healing process is impaired due to an imbalance of
the key biomolecules that orchestrate the wound healing process.
Kala believes that effective treatment of PCED across the various
etiologies requires a multifactorial mechanism of action, such as
that of KPI-012 . PCED is a rare disease with an
estimated incidence of 100,000 cases per year in the United States
and 238,000 cases per year in the United States, European Union and
Japan combined. KPI-012 has received Orphan Drug Designation from
the U.S. Food and Drug Administration (FDA) for the treatment of
PCED.
Limbal Stem Cell Deficiency (LSCD) is an ocular surface disease
characterized by the loss or deficiency of limbal epithelial stem
cells, which play an essential role in generation and repopulation
of corneal epithelial cells and maintenance of corneal clarity and
integrity. Due to their integral role in epithelial cell generation
and repopulation, LSCD can result in recurrent epithelial
breakdown, neovascularization, conjunctivalization, inflammation
and other sequalae that can lead to loss of corneal clarity and
vision impairment. Approximately 70% of LSCD patients – or about
70,000 patients in the United States – have partial deficiency of
the limbal stem cells (Partial LSCD). There are currently no
approved pharmaceutical products for the treatment of Partial LSCD,
and while current disease management techniques may be able to
impact certain sequalae, they do not address the underlying
pathology and often do not provide significant clinical benefit.
Patients with Partial LSCD could be appropriate candidates for a
cell-free regenerative therapy such as KPI-012, which acts to
maintain the integrity of the ocular surface and avoid the vision
impairment and pain associated with LSCD. Partial LSCD is estimated
to affect approximately 70,000 patients in the United States.
Sjögren’s is a chronic, multisystem autoimmune disease
characterized by insufficient fluid production in certain glands of
the body leading to substantial dryness, primarily dry eye and dry
mouth. Approximately 90% of Sjögren’s patients suffer from ocular
manifestations and can experience significant ocular symptoms,
which impact their daily life and productivity. As a result, the
quality of life in Sjögren’s patients can be significantly
diminished. Despite currently available treatments, many Sjögren’s
patients do not achieve significant improvement in their ocular
symptoms. There is a substantial need for new therapies that can
address the ocular symptoms, visual impairment and quality of life
for the approximately 95,000 moderate-to-severe Sjögren’s patients
in the United States.
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.
In connection with the decision to focus research and
development efforts on KPI-012, KPI-014 and its MSC-S platform,
Kala ceased the development of its other preclinical pipeline
programs, including KPI-287, its receptor tyrosine kinase
inhibitor, and selective glucocorticoid receptor modulators.
Corporate:
In July 2022, Kala completed the sale of its commercial
portfolio and related intellectual property assets to Alcon Inc.
The sale included EYSUVIS, the first and only FDA approved medicine
for the short-term (up to two weeks) treatment of the signs and
symptoms of dry eye disease, and INVELTYS, a twice-a-day
corticosteroid for the treatment of post-operative inflammation and
pain following ocular surgery. Kala received an upfront payment of
$60 million in cash at closing and is eligible to receive up to
$325 million in commercial-based sales milestones.
Financial Results:
The financial results and guidance 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, loss on extinguishment of
debt, transaction costs related to the Alcon transaction,
transaction costs related to the Combangio transaction, gain or
loss on fair value remeasurement of deferred purchase and
contingent consideration, acquired in-process research and
development and the impact of the termination of the lease for the
Company’s former corporate headquarters. Anticipated severance
costs are also excluded for the purposes of estimating projected
non-GAAP total operating expenses for the second half of 2022. 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 June 30, 2022, Kala had
cash, cash equivalents and short-term investments of $44.6 million,
compared to $92.1 million of cash and cash equivalents as of
December 31, 2021. This decrease reflects cash used in operations.
Kala’s cash position as of June 30, 2022 does not include net cash
received in July 2022 from the sale of its commercial business to
Alcon Inc. Based on its current plans, Kala anticipates that its
cash resources as of June 30, 2022, together with the net proceeds
from the Alcon transaction and associated reduction in operating
expenses, will enable it to fund its operations into the second
quarter of 2024. Following the closing of the Alcon transaction,
the Company reduced its corporate infrastructure, and anticipates
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.
Financial Results for the Three Months ended June 30,
2022:
- Net Product Revenues: For the quarter ended
June 30, 2022, Kala reported net product revenues of $2.1 million,
consisting of $0.9 million of net revenue from EYSUVIS sales and
$1.2 million of net revenue from INVELTYS sales, compared to net
product revenues of $3.1 million for the same period in 2021, which
consisted of $1.7 million of net revenues from EYSUVIS sales and
$1.4 million of net reviews from INVELTYS sales.
- Cost of Product Revenues: For the quarter
ended June 30, 2022, cost of product revenues was $1.8 million,
compared to $1.0 million for the same period in 2021. Non-GAAP cost
of product revenues was $1.6 million for the quarter ended June 30,
2022, compared to $1.0 million for the same period in 2021.
- SG&A Expenses: For the quarter ended June
30, 2022, selling, general and administrative (SG&A) expenses
were $22.7 million, compared to $28.0 million for the same period
in 2021. The decrease was primarily due to decreases in facility
costs, employee-rated costs and stock-based compensation expense.
Non-GAAP SG&A expenses were $20.4 million for the quarter ended
June 30, 2022, compared to $24.1 million for the same period in
2021.
- R&D Expenses: For the quarter ended June
30, 2022, research and development (R&D) expenses were $4.5
million, compared to $3.1 million for the same period in 2021. The
increase was primarily due to development costs for KPI-012.
Non-GAAP R&D expenses were $4.1 million for the quarter ended
June 30, 2022, compared to $2.1 million for the same period in
2021.
- Gain on Fair Value Remeasurement of Deferred Purchase
Consideration: For the quarter ended June 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 $0.8 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.
- Gain on Fair Value Remeasurement of Contingent
Consideration: For the quarter ended June 30, 2022, the
gain 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 June 30, 2022, loss from operations was $26.0
million, compared to $29.0 million for the same period in
2021. Non-GAAP operating loss was $24.0 million for the
quarter ended June 30, 2022, compared to $24.1
million for the same period in 2021.
- Net Loss: For the quarter ended June 30, 2022,
net loss was $28.1 million, or $0.38 per share, compared to a net
loss of $36.5 million, or $0.57 per share, for the same period in
2021. Non-GAAP net loss was $25.7 million for the quarter ended
June 30, 2022, compared to $25.8 million for the same period in
2021. The weighted average number of shares used to calculate net
loss per share was 73.7 million for the quarter ended June 30,
2022, and 64.6 million for the quarter ended June 30, 2021.
Financial Results for the Six Months ended June 30,
2022
- Net Product Revenues: For the six months ended
June 30, 2022, Kala reported net product revenues of $3.5 million,
consisting of $1.9 million of net revenue from EYSUVIS sales and
$1.6 million of net revenue from INVELTYS sales, compared to net
product revenues of $6.3 million for the six months ended June 30,
2021, which consisted of $3.3 million from EYSUVIS sales and $3.0
million from INVELTYS sales.
- Cost of Product Revenues: For the six months
ended June 30, 2022, cost of product revenues was $2.5 million,
compared to $1.8 million for the same period in 2021. Non-GAAP cost
of product revenues was $2.4 million for the six months ended June
30, 2022, compared to $1.7 million for the same period in
2021.
- SG&A Expenses: For the six months ended
June 30, 2022, SG&A expenses were $49.7 million, compared to
$55.7 million for the same period in 2021. The decrease was
primarily due to decreases in facility costs, employee-related
costs and stock-based compensation expense. Non-GAAP SG&A
expenses were $45.0 million for the six months ended June 30, 2022,
compared to $47.9 million for the same period in 2021.
- R&D Expenses: For the six months ended
June 30, 2022, R&D expenses were $8.9 million, compared to $6.2
million for the same period in 2021. The increase was primarily due
to development costs for KPI-012. Non-GAAP R&D expenses were
$8.0 million for the six months ended June 30, 2022, compared to
$4.2 million for the same period in 2021.
- Loss on Fair Value Remeasurement of Deferred Purchase
Consideration: For the six months ended June 30, 2022, the
loss on fair value remeasurement of deferred purchase
consideration, in connection with the acquisition of Combangio, was
$0.3 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 six months ended June 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 six months
ended June 30, 2022, loss from operations was $56.9
million, compared to $57.4 million for the same period in
2021. Non-GAAP operating loss was $51.9 million for the
six months ended June 30, 2022, compared to $47.4
million for the same period in 2021.
- Net Loss: For the six months ended June 30,
2022, net loss was $61.1 million, or $0.83 per share, compared to a
net loss of $66.9 million, or $1.06 per share, for the same period
in 2021. Non-GAAP net loss was $55.2 million for the six months
ended June 30, 2022, compared to $51.0 million for the same period
in 2021. The weighted average number of shares used to calculate
net loss per share was 73.7 million for the six months ended June
30, 2022, and 63.1 million for the six months ended June 30,
2021.
Conference Call Information
Kala will host a live conference call and webcast today, August
11, 2022, at 8:00 a.m. ET today to review its second quarter 2022
financial results. To access the live conference call, please dial
800-715-9871 five minutes prior to the start of the call and
provide the conference ID: 9372651. To access the live webcast and
subsequent archived recording of the call, please visit the
“Investor” section on the Kala website at http://kalarx.com.
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, loss on
extinguishment of debt, transaction costs related to the Alcon
transaction, transaction costs related to the Combangio
transaction, gain or loss on fair value remeasurement of deferred
purchase consideration and contingent consideration, acquired
in-process research and development and the impact of the
termination of the lease for the Company’s former corporate
headquarters. Anticipated severance costs are also excluded for the
purposes of estimating projected non-GAAP total operating expenses
for the second half of 2022. 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. 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. 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.
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 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
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;
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 and the risk that Kala
may not realize the expected benefits of the transaction; 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: Kala’s ability to realize
the anticipated benefits of the transaction with Alcon, including
the uncertainty regarding the receipt of any milestone payments;
the impact of extraordinary external events, such as the current
pandemic health event resulting from the novel coronavirus
(COVID-19), and their collateral consequences; 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 in PCED or
any other indications; uncertainties as to the timing of and Kala’s
ability to submit and obtain regulatory clearance for an
investigational new drug application for KPI-012 and initiate a
clinical trial; 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 the 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.com212-362-1200
Financial Tables
Kala Pharmaceuticals, Inc. |
Balance Sheet Data |
(in thousands) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2022 |
|
|
|
2021 |
Cash, cash equivalents and
short-term investments |
|
|
$ |
44,568 |
|
|
|
$ |
92,136 |
Total assets |
|
|
|
84,976 |
|
|
|
|
139,427 |
Working capital (1) |
|
|
|
50,624 |
|
|
|
|
86,944 |
Long-term debt, net of
discounts |
|
|
|
79,800 |
|
|
|
|
78,929 |
Other long-term
liabilities |
|
|
|
3,839 |
|
|
|
|
6,272 |
Total stockholders’ (deficit)
equity |
|
|
|
(31,554 |
) |
|
|
|
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 |
|
|
Six Months Ended |
|
|
June 30, |
|
|
June 30, |
|
|
2022 |
|
|
2021 |
|
|
|
2022 |
|
|
2021 |
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues, net |
|
$ |
2,100 |
|
|
$ |
3,051 |
|
|
|
$ |
3,472 |
|
|
$ |
6,317 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenues |
|
|
1,774 |
|
|
|
1,016 |
|
|
|
|
2,549 |
|
|
|
1,771 |
|
Selling, general and administrative |
|
|
22,673 |
|
|
|
27,986 |
|
|
|
|
49,655 |
|
|
|
55,685 |
|
Research and development |
|
|
4,473 |
|
|
|
3,094 |
|
|
|
|
8,939 |
|
|
|
6,220 |
|
(Gain) loss on fair value remeasurement of
deferred purchase consideration |
|
|
(789 |
) |
|
|
— |
|
|
|
|
262 |
|
|
|
— |
|
Gain on fair value remeasurement of contingent consideration |
|
|
(59 |
) |
|
|
— |
|
|
|
|
(1,047 |
) |
|
|
— |
|
Total operating expenses |
|
|
28,072 |
|
|
|
32,096 |
|
|
|
|
60,358 |
|
|
|
63,676 |
|
Loss from operations |
|
|
(25,972 |
) |
|
|
(29,045 |
) |
|
|
|
(56,886 |
) |
|
|
(57,359 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
68 |
|
|
|
33 |
|
|
|
|
76 |
|
|
|
76 |
|
Interest expense |
|
|
(2,207 |
) |
|
|
(2,091 |
) |
|
|
|
(4,242 |
) |
|
|
(4,232 |
) |
Loss on extinguishment of debt |
|
|
— |
|
|
|
(5,395 |
) |
|
|
|
— |
|
|
|
(5,395 |
) |
Net loss |
|
|
(28,111 |
) |
|
|
(36,498 |
) |
|
|
|
(61,052 |
) |
|
|
(66,910 |
) |
Net loss per share
attributable to common stockholders—basic and diluted |
|
$ |
(0.38 |
) |
|
$ |
(0.57 |
) |
|
|
$ |
(0.83 |
) |
|
$ |
(1.06 |
) |
Weighted average shares
outstanding—basic and diluted |
|
|
73,676,819 |
|
|
|
64,554,506 |
|
|
|
|
73,658,924 |
|
|
|
63,113,194 |
|
Kala Pharmaceuticals,
Inc.Reconciliation of GAAP to Non-GAAP Financial
Measures(In
thousands)(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss (GAAP) |
|
$ |
(28,111 |
) |
|
$ |
(36,498 |
) |
|
$ |
(61,052 |
) |
|
$ |
(66,910 |
) |
Add-back: stock-based compensation expense |
|
|
1,916 |
|
|
|
4,710 |
|
|
|
4,721 |
|
|
|
9,412 |
|
Add-back: non-cash interest |
|
|
439 |
|
|
|
367 |
|
|
|
871 |
|
|
|
645 |
|
Add-back: depreciation and amortization |
|
|
149 |
|
|
|
256 |
|
|
|
306 |
|
|
|
504 |
|
Add-back: loss on extinguishment of debt |
|
|
— |
|
|
|
5,395 |
|
|
|
— |
|
|
|
5,395 |
|
Add-back: transaction costs related to the Alcon transaction |
|
|
758 |
|
|
|
— |
|
|
|
758 |
|
|
|
— |
|
Add-back: (gain) loss on fair value remeasurement of deferred
purchase consideration |
|
|
(789 |
) |
|
|
— |
|
|
|
262 |
|
|
|
— |
|
Add-back: gain on fair value remeasurement of contingent
consideration |
|
|
(59 |
) |
|
|
— |
|
|
|
(1,047 |
) |
|
|
— |
|
Non-GAAP net loss |
|
$ |
(25,697 |
) |
|
$ |
(25,770 |
) |
|
$ |
(55,181 |
) |
|
$ |
(50,954 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenues (GAAP) |
|
$ |
1,774 |
|
|
$ |
1,016 |
|
|
$ |
2,549 |
|
|
$ |
1,771 |
|
Less: stock-based compensation expense |
|
|
114 |
|
|
|
37 |
|
|
|
162 |
|
|
|
71 |
|
Less: depreciation and amortization |
|
|
13 |
|
|
|
13 |
|
|
|
26 |
|
|
|
26 |
|
Non-GAAP cost of product revenues |
|
$ |
1,647 |
|
|
$ |
966 |
|
|
$ |
2,361 |
|
|
$ |
1,674 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative expenses (GAAP) |
|
$ |
21,915 |
|
|
$ |
27,986 |
|
|
$ |
49,655 |
|
|
$ |
55,685 |
|
Less: stock-based compensation expense |
|
|
1,480 |
|
|
|
3,687 |
|
|
|
3,712 |
|
|
|
7,389 |
|
Less: depreciation and amortization |
|
|
83 |
|
|
|
187 |
|
|
|
172 |
|
|
|
368 |
|
Less: transaction costs related to the Alcon transaction |
|
|
758 |
|
|
|
— |
|
|
|
758 |
|
|
|
— |
|
Non-GAAP selling, general and administrative expenses |
|
$ |
20,352 |
|
|
$ |
24,112 |
|
|
$ |
45,013 |
|
|
$ |
47,928 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses (GAAP) |
|
$ |
4,473 |
|
|
$ |
3,094 |
|
|
$ |
8,939 |
|
|
$ |
6,220 |
|
Less: stock-based compensation expense |
|
|
322 |
|
|
|
986 |
|
|
|
847 |
|
|
|
1,952 |
|
Less: depreciation and amortization |
|
|
53 |
|
|
|
56 |
|
|
|
108 |
|
|
|
110 |
|
Non-GAAP research and development expenses |
|
$ |
4,098 |
|
|
$ |
2,052 |
|
|
$ |
7,984 |
|
|
$ |
4,158 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Gain) loss on fair value remeasurement of deferred purchase
consideration |
|
$ |
(789 |
) |
|
$ |
— |
|
|
$ |
262 |
|
|
$ |
— |
|
Less: (gain) loss on fair value remeasurement of deferred purchase
consideration |
|
|
(789 |
) |
|
|
— |
|
|
|
262 |
|
|
|
— |
|
Non-GAAP (gain) loss on fair value remeasurement of deferred
purchase consideration |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain on fair value remeasurement of contingent consideration |
|
$ |
(59 |
) |
|
$ |
— |
|
|
$ |
(1,047 |
) |
|
$ |
— |
|
Less: gain on fair value remeasurement of contingent
consideration |
|
|
(59 |
) |
|
|
— |
|
|
|
(1,047 |
) |
|
|
— |
|
Non-GAAP gain on fair value remeasurement of contingent
consideration |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses (GAAP) |
|
$ |
28,072 |
|
|
$ |
32,096 |
|
|
$ |
60,358 |
|
|
$ |
63,676 |
|
Less: stock-based compensation expense |
|
|
1,916 |
|
|
|
4,710 |
|
|
|
4,721 |
|
|
|
9,412 |
|
Less: depreciation and amortization |
|
|
149 |
|
|
|
256 |
|
|
|
306 |
|
|
|
504 |
|
Less: transaction costs related to the Alcon transaction |
|
|
758 |
|
|
|
— |
|
|
|
758 |
|
|
|
— |
|
Less: (gain) loss on fair value remeasurement of deferred purchase
consideration |
|
|
(789 |
) |
|
|
— |
|
|
|
262 |
|
|
|
— |
|
Less: gain on fair value remeasurement of contingent
consideration |
|
|
(59 |
) |
|
|
— |
|
|
|
(1,047 |
) |
|
|
— |
|
Non-GAAP total operating expenses |
|
$ |
26,097 |
|
|
$ |
27,130 |
|
|
$ |
55,358 |
|
|
$ |
53,760 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating loss (GAAP) |
|
$ |
(25,972 |
) |
|
$ |
(29,045 |
) |
|
$ |
(56,886 |
) |
|
$ |
(57,359 |
) |
Add-back: stock-based compensation expense |
|
|
1,916 |
|
|
|
4,710 |
|
|
|
4,721 |
|
|
|
9,412 |
|
Add-back: depreciation and amortization |
|
|
149 |
|
|
|
256 |
|
|
|
306 |
|
|
|
504 |
|
Add-back: transaction costs related to the Alcon transaction |
|
|
758 |
|
|
|
— |
|
|
|
758 |
|
|
|
— |
|
Add-back: (gain) loss on fair value remeasurement of deferred
purchase consideration |
|
|
(789 |
) |
|
|
— |
|
|
|
262 |
|
|
|
— |
|
Add-back: gain on fair value remeasurement of contingent
consideration |
|
|
(59 |
) |
|
|
— |
|
|
|
(1,047 |
) |
|
|
— |
|
Non-GAAP total operating loss |
|
$ |
(23,997 |
) |
|
$ |
(24,079 |
) |
|
$ |
(51,886 |
) |
|
$ |
(47,443 |
) |
Kala Pharmaceuticals,
Inc.Reconciliation of GAAP to Non-GAAP Financial
Measures(In
thousands)(Unaudited)
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, 2022 |
|
Year Ended December 31, 2021 |
|
|
|
|
|
|
|
Net loss (GAAP) |
|
$ |
32,941 |
|
|
$ |
142,605 |
|
Add-back: stock-based compensation expense |
|
|
2,805 |
|
|
|
16,088 |
|
Add-back: non-cash interest |
|
|
432 |
|
|
|
1,519 |
|
Add-back: depreciation and amortization |
|
|
157 |
|
|
|
975 |
|
Add-back: loss on extinguishment of debt |
|
|
— |
|
|
|
5,395 |
|
Add-back: acquired in-process research and development |
|
|
— |
|
|
|
26,617 |
|
Add-back: loss (gain) on fair value remeasurement of deferred
purchase consideration |
|
|
1,051 |
|
|
|
(5,805 |
) |
Add-back: gain on fair value remeasurement of contingent
consideration |
|
|
(988 |
) |
|
|
— |
|
Add back: transaction costs related to acquisition of Combangio,
Inc. |
|
|
— |
|
|
|
1,179 |
|
Add-back: impact of lease modification |
|
|
— |
|
|
|
(2,467 |
) |
Non-GAAP net loss |
|
$ |
(29,484 |
) |
|
$ |
(99,104 |
) |
|
|
|
|
|
|
|
Cost of product revenues (GAAP) |
|
$ |
775 |
|
|
$ |
4,097 |
|
Less: stock-based compensation expense |
|
|
48 |
|
|
|
169 |
|
Less: depreciation and amortization |
|
|
13 |
|
|
|
52 |
|
Non-GAAP cost of product revenues |
|
$ |
714 |
|
|
$ |
3,876 |
|
|
|
|
|
|
|
|
Selling, general and administrative expenses (GAAP) |
|
$ |
26,982 |
|
|
$ |
105,061 |
|
Less: stock-based compensation expense |
|
|
2,232 |
|
|
|
12,774 |
|
Less: depreciation and amortization |
|
|
89 |
|
|
|
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 |
|
$ |
24,661 |
|
|
$ |
91,571 |
|
|
|
|
|
|
|
|
Research and development expenses (GAAP) |
|
$ |
4,466 |
|
|
$ |
11,515 |
|
Less: stock-based compensation expense |
|
|
525 |
|
|
|
3,145 |
|
Less: depreciation and amortization |
|
|
55 |
|
|
|
230 |
|
Non-GAAP research and development expenses |
|
$ |
3,886 |
|
|
$ |
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 |
|
$ |
— |
|
|
$ |
— |
|
|
|
|
|
|
|
|
Loss (gain) on fair value remeasurement of deferred purchase
consideration |
|
$ |
1,051 |
|
|
$ |
(5,805 |
) |
Less: loss (gain) on fair value remeasurement of deferred purchase
consideration |
|
|
1,051 |
|
|
|
(5,805 |
) |
Non-GAAP (gain) loss on fair value remeasurement of deferred
purchase consideration |
|
$ |
— |
|
|
$ |
— |
|
|
|
|
|
|
|
|
Gain on fair value remeasurement of contingent consideration |
|
$ |
(988 |
) |
|
$ |
— |
|
Less: gain on fair value remeasurement of contingent
consideration |
|
|
(988 |
) |
|
|
— |
|
Non-GAAP gain on fair value remeasurement of contingent
consideration |
|
$ |
— |
|
|
$ |
— |
|
|
|
|
|
|
|
|
Total operating expenses (GAAP) |
|
$ |
32,286 |
|
|
$ |
141,485 |
|
Less: stock-based compensation expense |
|
|
2,805 |
|
|
|
16,088 |
|
Less: depreciation and amortization |
|
|
157 |
|
|
|
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: loss on fair value remeasurement of deferred purchase
consideration |
|
|
1,051 |
|
|
|
(5,805 |
) |
Less: gain on fair value remeasurement of contingent
consideration |
|
|
(988 |
) |
|
|
— |
|
Non-GAAP total operating expenses |
|
$ |
29,261 |
|
|
$ |
103,587 |
|
|
|
|
|
|
|
|
Total operating loss (GAAP) |
|
$ |
(30,914 |
) |
|
$ |
(130,245 |
) |
Add-back: stock-based compensation expense |
|
|
2,805 |
|
|
|
16,088 |
|
Add-back: depreciation and amortization |
|
|
157 |
|
|
|
975 |
|
Add-back: acquired in-process research and development |
|
|
— |
|
|
|
26,617 |
|
Add-back: loss (gain) on fair value remeasurement of deferred
purchase consideration |
|
|
1,051 |
|
|
|
(5,805 |
) |
Add-back: gain on fair value remeasurement of contingent
consideration |
|
|
(988 |
) |
|
|
— |
|
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 |
|
$ |
(27,889 |
) |
|
$ |
(92,347 |
) |
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