Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a clinical-stage
biopharmaceutical company dedicated to the research, development
and commercialization of innovative therapies for rare and severe
diseases of the eye, today reported financial results for the
fourth quarter and full year ended December 31, 2022 and provided a
corporate update.
“2022 was a transformational year for Kala. In the third
quarter, we completed the sale of EYSUVIS® and INVELTYS® to Alcon
Inc., enabling us to devote our full attention to developing
innovative therapies, including KPI-012, for rare and severe eye
diseases,” said Mark Iwicki, Chief Executive Officer and Chairman
of Kala Pharmaceuticals. “In the months since, we made great
progress advancing KPI-012 for the treatment of persistent corneal
epithelial defect (PCED), a rare and debilitating ocular condition.
We recently enrolled the first patient in our CHASE Phase 2b
clinical trial of KPI-012, potentially the first of two pivotal
studies required to support an application for marketing approval
in the United States, and we are targeting top-line safety and
efficacy data in the first quarter of 2024. In addition, following
the completion of our $31.0 million private placement financing in
the fourth quarter of 2022 and coupled with our streamlined
corporate structure, we are operating from a position of financial
strength, with capital well beyond the anticipated readout from the
CHASE trial.”
Fourth Quarter and Recent Business
Highlights:
Development-Stage Pipeline:In February 2023,
Kala dosed the first patient in its CHASE (Corneal
Healing After
SEcretome therapy) Phase 2b clinical trial
evaluating KPI-012 for PCED in the United States. The CHASE Phase
2b clinical trial is a multicenter, randomized, double-masked,
vehicle-controlled, parallel-group study to evaluate the safety and
efficacy of two doses of KPI-012 ophthalmic solution (3 U/mL and 1
U/mL) compared to vehicle when dosed topically four times per day
(QID) for 56 days. After the first cohort with two initial patients
to evaluate the safety of the high dose, patients in the second
cohort will be randomized to treatment with either KPI-012 or
vehicle. The trial is expected to enroll approximately 90 adult
patients with PCED, and the primary endpoint of the trial is the
complete healing of the PCED as measured by corneal fluorescein
staining. Kala is targeting top-line safety and efficacy data from
the CHASE Phase 2b clinical trial in the first quarter of 2024. If
the results are positive, and subject to discussions with
regulatory authorities, Kala believes this trial could serve as the
first of two pivotal trials required to support the submission of a
Biologics License Application (BLA) to the U.S. Food and Drug
Administration (FDA). Kala has received Orphan Drug Designation
from the FDA for KPI-012 for the treatment of PCED.
Kala believes the multifactorial mechanism of action of KPI-012
makes it a platform technology and is evaluating the potential
development of KPI-012 for additional rare, front-of-the-eye
diseases, such as Limbal Stem Cell Deficiency and ocular
manifestations of moderate-to-severe Sjögren’s. Kala has also
initiated preclinical studies for its KPI-014 program, evaluating
the utility of its mesenchymal stem cell secretome (MSC-S) platform
for inherited retinal degenerative diseases such as Retinitis
Pigmentosa and Stargardt Disease.
Corporate Updates:In December 2022, Kala closed
a private placement financing, raising aggregate gross proceeds of
$31.0 million. Under the terms of the private placement, Kala sold
an aggregate of 76,813 shares of its common stock at a price of
$5.75 per share and an aggregate of 53,144 shares of its Series E
Convertible Non-Redeemable Preferred Stock at a price of $575.00
per share to a life sciences-focused investor.
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, acquired
in-process research and development (IPR&D) expense,
transaction costs related to the Alcon, Inc. (Alcon) and Combangio,
Inc. (Combangio) transactions, 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, the impact of the termination of the lease for the Company’s
former corporate headquarters 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 December 31, 2022, Kala
had cash and cash equivalents of $70.5 million, compared to $52.4
million as of September 30, 2022. This increase reflects the gross
proceeds of $31.0 million received from Kala’s private placement
financing, which closed in December 31, 2022, partially offset by
cash used in operations. In January 2023, Kala raised net proceeds
of $11.4 million under its at-the-market (ATM) offering program and
used approximately $10 million to prepay a portion of the principal
on its debt facility. Based on its current plans, Kala anticipates
that its cash resources as of December 31, 2022 will enable it to
fund operations into the first quarter of 2025.
Fourth Quarter 2022 Financial Results:
- Net Product Revenues: Kala did not
recognize product revenues in the fourth quarter of 2022, following
the sale of its commercial portfolio to Alcon on July 8, 2022. For
the quarter ended December 31, 2021, Kala reported net product
revenues of $1.9 million.
- Cost of Product Revenues: Kala did not
record cost of product revenues in the fourth quarter of 2022
following the sale of its commercial portfolio to Alcon on July 8,
2022. For the quarter ended December 31, 2021, cost of product
revenues was $1.4 million. Non-GAAP cost of product revenues were
$1.3 million for the quarter ended December 31, 2021.
- SG&A Expenses: For the quarter ended
December 31, 2022, selling, general and administrative (SG&A)
expenses were $5.8 million, compared to $24.0 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,
and related workforce reduction. Non-GAAP SG&A expenses were
$5.0 million for the quarter ended December 31, 2022, compared to
$21.5 million for the same period in 2021.
- R&D Expenses: For the quarter ended
December 31, 2022, research and development (R&D) expenses were
$3.3 million, compared to $2.4 million for the same period in 2021.
The increase was primarily due to the increase in development costs
for KPI-012. Non-GAAP R&D expenses were $3.1 million for the
quarter ended December 31, 2022, compared to $2.0 million for the
same period in 2021.
- Acquired IPR&D Expenses: There were
no acquired IPR&D expenses for the quarter ended
December 31, 2022. For the quarter ended December 31,
2021, acquired IPR&D expenses were $26.6 million and were costs
associated with the acquisition of acquired IPR&D assets from
Combangio in November 2021. Non-GAAP operating loss and net
loss exclude acquired IPR&D expenses.
- Loss (Gain) on Fair Value Remeasurement of Deferred
Purchase Consideration: For the quarter ended
December 31, 2022, the loss on fair value remeasurement of deferred
purchase consideration, in connection with the acquisition of
Combangio, was $0.4 million. For the quarter ended December 31,
2021, the gain on fair value remeasurement of deferred purchase
consideration was $5.8 million. Non-GAAP operating loss and
non-GAAP net loss exclude the loss (gain) on fair value
remeasurement of deferred purchase consideration.
- Loss on Fair Value Remeasurement of Contingent
Consideration: For the quarter ended December 31,
2022, the loss on fair value remeasurement of contingent
consideration, in connection with the Combangio acquisition, was
$0.7 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 loss on fair value
remeasurement of contingent consideration.
- Operating Loss: For the quarter
ended December 31, 2022, loss from operations was $10.3
million, compared to $46.8 million for the same period in
2021. Non-GAAP operating loss was $8.1 million for the
quarter ended December 31, 2022, compared to $23.0
million for the same period in 2021.
- Net Loss: For the quarter ended December
31, 2022, Kala reported a net loss of $12.8 million, or a basic and
diluted net loss per share of $7.97, compared to a net loss of
$47.6 million, or $33.94 per share on a basic and diluted basis,
for the same period in 2021. Non-GAAP net loss was $10.4 million
for the quarter ended December 31, 2022, compared to $24.6 million
for the same period in 2021. The weighted average number of shares
used to calculate net loss per share was 1.6 million for the
quarter ended December, 2022, and 1.4 million for the quarter ended
December 31, 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 prices. The
weighted average number of shares used to calculate net loss has
been retroactively adjusted for all periods presented in this press
release to reflect the reverse stock split.
Financial Results for Full Year ended December 31,
2022:
- Net Product Revenues: For the full year
ended December 31, 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 $11.2 million.
- Cost of Product Revenues: For the full
year ended December 31, 2022, cost of product revenues was $2.6
million, compared to $4.1 million for the same period in 2021.
Non-GAAP cost of product revenues was $2.4 million for the full
year ended December 31, 2022, compared to $3.9 million for the same
period in 2021.
- SG&A Expenses: For the full year
ended December 31, 2022, SG&A expenses were $65.0 million,
compared to $105.1 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 $58.4 million for the full year ended December 31,
2022, compared to $91.6 million for the same period in 2021.
- R&D Expenses: For the full year ended
December 31, 2022, R&D expenses were $17.7 million, compared to
$11.5 million for the same period in 2021. The increase was
primarily due to development costs for KPI-012. Non-GAAP R&D
expenses were $16.2 million for the full year ended December 31,
2022, compared to $8.1 million for the same period in 2021.
- Acquired IPR&D Expenses: There were
no acquired IPR&D expenses for the full year ended
December 31, 2022. For the full year ended December 31,
2021, acquired IPR&D were $26.6 million and were costs
associated with the acquisition of acquired IPR&D assets from
Combangio. Non-GAAP operating loss and net loss exclude
acquired IPR&D expenses.
- Loss (Gain) on Fair Value Remeasurement of Deferred
Purchase Consideration: For the full year ended
December 31, 2022, the loss on fair value remeasurement of deferred
purchase consideration, in connection with the acquisition of
Combangio, was $0.6 million. For the full year ended December 31,
2021, the gain on fair value remeasurement of deferred purchase
consideration was $5.8 million. Non-GAAP operating loss and
non-GAAP net loss exclude the gain or loss on fair value
remeasurement of deferred purchase consideration.
- Gain on Fair Value Remeasurement of Contingent
Consideration: For the full year ended December 31,
2022, the gain on fair value remeasurement of contingent
consideration, in connection with the Combangio acquisition, was
$0.3 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 full year ended
December 31, 2022, loss from operations was $81.7 million,
compared to $130.2 million for the same period in 2021.
Non-GAAP operating loss was $73.1 million for the full
year ended December 31, 2022, compared to $92.3
million for the same period in 2021.
- Loss on Extinguishment of Debt: For the full
year ended December 31, 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 its loan
agreement with Oxford Finance LLC in connection with the closing of
the sale of its commercial business to Alcon. For the full year
ended December 31, 2021, Kala reported a loss on extinguishment of
debt of $5.4 million as a result of the repayment in full of all
amounts owed under the credit agreement with Athyrium Opportunities
III Acquisition LP in May 2021.
- Gain on Sale of Commercial Business: For
the full year ended December 31, 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 full year ended
December 31, 2022, net loss was $44.8 million, or $29.48 per share,
compared to a net loss of $142.6 million, or $108.32 per share, for
the same period in 2021. Non-GAAP net loss was $79.1 million for
the full year ended December 31, 2022, compared to $99.1 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 full
year ended December 31, 2022, and 1.3 million for the full year
ended December 31, 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 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, acquired in-process research and development expense,
transaction costs related to the Alcon and Combangio transactions,
gain or loss on fair value remeasurement of deferred purchase
consideration and contingent consideration, gain on sale of the
commercial business, loss on extinguishment of debt, the impact of
the termination of the lease for the Company’s former corporate
headquarters and other non-cash expenses. 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.
About Kala Pharmaceuticals, Inc.
Kala is a clinical-stage biopharmaceutical company dedicated to
the research, development and commercialization of innovative
therapies for rare and severe 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 a human MSC-S, which
contains numerous human-derived biofactors, 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. KPI-012 is
currently in clinical development for the treatment of persistent
corneal epithelial defect (PCED), a rare disease of impaired
corneal healing, for which it 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 Limbal
Stem Cell Deficiency and ocular manifestations of
moderate-to-severe Sjögren's and has initiated preclinical studies
to evaluate the potential utility of its MSC-S platform for
inherited 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; anticipated timelines to report topline data for the
CHASE Phase 2b clinical trial of KPI-012; the design of the CHASE
Phase 2b clinical trial; Kala’s belief that the Chase Phase 2b
trial could serve as the first of two pivotal trials required to
support the submission of a BLA to the FDA; the clinical utility of
KPI-012 for PCED; Kala’s plans to pursue research and development
of KPI-012 and its MSC-S platform for other indications and to
apply for RMAT designation; the sufficiency of Kala’s existing cash
resources for the period anticipated; 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: 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, including the
planned Phase 2b 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
impact of extraordinary external events, such as the current
pandemic health event resulting from the coronavirus (COVID-19),
and their collateral consequences; 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) |
|
|
|
|
|
|
|
December 31, |
|
December 31, |
|
2022 |
|
2021 |
Cash and cash equivalents |
$ |
70,495 |
|
$ |
92,136 |
Total assets |
|
86,820 |
|
|
139,427 |
Working capital (1) |
|
60,257 |
|
|
86,944 |
Longterm debt, net of
discounts |
|
37,937 |
|
|
78,929 |
Other long-term
liabilities |
|
4,224 |
|
|
6,272 |
Total stockholders’
equity |
|
18,974 |
|
|
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 |
|
Year Ended |
|
December 31, |
|
December 31, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
|
|
|
|
|
|
|
|
|
Product revenues, net |
$ |
— |
|
$ |
1,856 |
|
$ |
3,892 |
|
$ |
11,240 |
Costs and
expenses: |
|
|
|
|
|
|
|
|
|
|
Cost of product revenues |
|
— |
|
|
1,418 |
|
|
2,560 |
|
|
4,097 |
Selling, general and administrative |
|
5,831 |
|
|
24,027 |
|
|
65,035 |
|
|
105,061 |
Research and development |
|
3,323 |
|
|
2,414 |
|
|
17,653 |
|
|
11,515 |
Acquired in-process research and development |
|
— |
|
|
26,617 |
|
|
— |
|
|
26,617 |
Loss (gain) loss on fair value remeasurement of deferred |
433 |
|
(5,805) |
|
638 |
|
(5,805) |
purchase consideration |
|
|
|
Loss (gain) on fair value remeasurement of |
664 |
|
— |
|
(288) |
|
— |
contingent consideration |
|
|
|
Total operating expenses |
|
10,251 |
|
|
48,671 |
|
|
85,598 |
|
|
141,485 |
Loss from
operations |
|
(10,251) |
|
|
(46,815) |
|
|
(81,706) |
|
(130,245) |
Other income
(expense): |
|
|
|
|
|
|
|
|
|
|
Interest income |
|
354 |
|
|
12 |
|
|
664 |
|
104 |
Interest expense |
|
(1,577) |
|
|
(2,076) |
|
|
(7,266) |
|
(8,380) |
Loss on extinguishment of debt |
|
— |
|
|
— |
|
|
(2,583) |
|
(5,395) |
Gain on sale of Commercial Business |
|
— |
|
|
— |
|
|
46,995 |
|
— |
Gain on lease modification |
|
— |
|
|
1,311 |
|
|
— |
|
1,311 |
Other income (expense), net |
|
(1,369) |
|
|
— |
|
|
(926) |
|
|
— |
Net loss |
$ |
(12,843) |
|
$ |
(47,568) |
|
$ |
(44,822) |
|
$ |
(142,605) |
Net loss per share
attributable to common |
$ |
(7.97) |
|
$ |
(33.94) |
|
$ |
(29.48) |
|
$ |
(108.32) |
stockholders—basic and diluted |
|
|
|
Weighted average
shares outstanding—basic and |
1,611,375 |
|
1,401,729 |
|
1,520,611 |
|
1,316,495 |
diluted |
|
|
|
|
|
|
|
|
|
|
|
|
Kala Pharmaceuticals, Inc. |
Reconciliation of GAAP to non-GAAP Financial
Measures |
(In thousands) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Year Ended |
|
December 31, |
|
December 31, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss (GAAP) |
$ |
(12,843) |
|
$ |
(47,568) |
|
$ |
(44,822) |
|
$ |
(142,605) |
Add-back: stock-based compensation expense |
|
960 |
|
|
2,748 |
|
|
7,008 |
|
|
16,088 |
Add-back: non-cash interest |
|
295 |
|
|
439 |
|
|
1,425 |
|
|
1,519 |
Add-back: depreciation and amortization |
|
80 |
|
|
212 |
|
|
537 |
|
|
975 |
Add-back: acquired in-process research and development |
|
— |
|
|
26,617 |
|
|
— |
|
|
26,617 |
Add-back: transaction costs related to the Alcon |
— |
|
— |
|
758 |
|
— |
transaction |
|
|
|
Add back: transaction costs related to acquisition of |
— |
|
1,179 |
|
— |
|
1,179 |
Combangio, Inc. |
|
|
|
Add loss (gain) on fair value remeasurement of deferred |
433 |
|
(5,805) |
|
638 |
|
(5,805) |
purchase consideration |
|
|
|
Add: loss (gain) on fair value remeasurement of |
664 |
|
— |
|
(288) |
|
— |
contingent consideration |
|
|
|
Add-back: gain on sale of Commercial Business |
|
— |
|
|
— |
|
|
(46,995) |
|
|
— |
Add-back: loss on debt extinguishment |
|
— |
|
|
— |
|
|
2,583 |
|
|
5,395 |
Add-back: impact of lease modification |
|
— |
|
|
(2,467) |
|
|
— |
|
|
(2,467) |
Add-back: other (income) expense |
|
(4) |
|
|
— |
|
|
90 |
|
|
— |
non-GAAP net loss |
$ |
(10,415) |
|
$ |
(24,645) |
|
$ |
(79,066) |
|
$ |
(99,104) |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenues (GAAP) |
$ |
— |
|
$ |
1,418 |
|
$ |
2,560 |
|
$ |
4,097 |
Less: stock-based compensation expense |
|
— |
|
|
60 |
|
|
166 |
|
|
169 |
Less: depreciation and amortization |
|
— |
|
|
13 |
|
|
33 |
|
|
52 |
non-GAAP cost of product revenues |
$ |
— |
|
$ |
1,345 |
|
$ |
2,361 |
|
$ |
3,876 |
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative expenses (GAAP) |
$ |
5,831 |
|
$ |
24,027 |
|
$ |
65,035 |
|
$ |
105,061 |
Less: stock-based compensation expense |
|
753 |
|
|
2,364 |
|
|
5,550 |
|
|
12,774 |
Less: depreciation and amortization |
|
59 |
|
|
140 |
|
|
332 |
|
|
693 |
Less: transaction costs related to the Alcon transaction |
|
— |
|
|
— |
|
|
758 |
|
|
— |
Less: transaction costs related to acquisition of |
— |
|
1,179 |
|
— |
|
1,179 |
Combangio, Inc. |
|
|
|
Less: impact of lease modification |
|
— |
|
|
(1,156) |
|
|
— |
|
|
(1,156) |
non-GAAP selling, general and administrative expenses |
$ |
5,019 |
|
$ |
21,500 |
|
$ |
58,395 |
|
$ |
91,571 |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
expenses (GAAP) |
$ |
3,323 |
|
$ |
2,414 |
|
$ |
17,653 |
|
$ |
11,515 |
Less: stock-based compensation
expense |
|
207 |
|
|
324 |
|
|
1,292 |
|
|
3,145 |
Less: depreciation and
amortization |
|
21 |
|
|
59 |
|
|
172 |
|
|
230 |
non-GAAP research and
development expenses |
$ |
3,095 |
|
$ |
2,031 |
|
$ |
16,189 |
|
$ |
8,140 |
|
|
|
|
|
|
|
|
|
|
|
|
Acquired in-process research and development expenses |
$ |
— |
|
$ |
26,617 |
|
$ |
— |
|
$ |
26,617 |
(GAAP) |
|
|
|
Less: acquired in-process research and development |
— |
|
26,617 |
|
— |
|
26,617 |
expenses |
|
|
|
non-GAAP acquired in-process research and development |
$ |
— |
|
$ |
— |
|
$ |
— |
|
$ |
— |
expenses |
|
|
|
Loss (gain) on fair value remeasurement of deferred |
$ |
433 |
|
$ |
(5,805) |
|
$ |
638 |
|
$ |
(5,805) |
purchase consideration |
|
|
|
Less: loss (gain) on fair value remeasurement of deferred |
433 |
|
(5,805) |
|
638 |
|
(5,805) |
purchase consideration |
|
|
|
non-GAAP gain or loss on fair value remeasurement of |
$ |
— |
|
$ |
— |
|
$ |
— |
|
$ |
— |
deferred purchase consideration |
|
|
|
Loss (gain) on fair value remeasurement of contingent |
$ |
664 |
|
$ |
— |
|
$ |
(288) |
|
$ |
— |
consideration |
|
|
|
Less: loss (gain) on fair value remeasurement of |
664 |
|
— |
|
(288) |
|
— |
contingent consideration |
|
|
|
non-GAAP gain or loss on fair value remeasurement of |
$ |
— |
|
$ |
— |
|
$ |
— |
|
$ |
— |
contingent consideration |
|
|
|
Total operating loss (GAAP) |
$ |
(10,251) |
|
$ |
(46,815) |
|
$ |
(81,706) |
|
$ |
(130,245) |
Add-back: stock-based compensation expense |
|
960 |
|
|
2,748 |
|
|
7,008 |
|
|
16,088 |
Add-back: depreciation and amortization |
|
80 |
|
|
212 |
|
|
537 |
|
|
975 |
Add-back: acquired in-process research and development |
|
|
|
|
26,617 |
|
|
— |
|
|
26,617 |
Add-back: transaction costs related to the Alcon |
— |
|
— |
|
758 |
|
— |
transaction |
|
|
|
Add-back: transaction costs related to acquisition of |
— |
|
1,179 |
|
— |
|
1,179 |
Combangio, Inc. |
|
|
|
Add: loss (gain) on fair value remeasurement of deferred |
433 |
|
(5,805) |
|
638 |
|
(5,805) |
purchase consideration |
|
|
|
Add: loss (gain) on fair value remeasurement of |
664 |
|
— |
|
(288) |
|
— |
contingent consideration |
|
|
|
Add-back: impact of lease modification |
|
— |
|
|
(1,156) |
|
|
— |
|
|
(1,156) |
non-GAAP total operating loss |
$ |
(8,114) |
|
$ |
(23,020) |
|
$ |
(73,053) |
|
$ |
(92,347) |
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