Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a commercial-stage
biopharmaceutical company focused on the discovery, development and
commercialization of innovative therapies for diseases of the eye,
today reported financial results for the second quarter ended June
30, 2021 and provided a corporate update.
“In recent months, we have made substantial progress toward
establishing EYSUVIS as the preferred prescription therapy for the
short-term treatment of dry eye disease, expanding market access
with Commercial and Medicare Part D health plans and strengthening
our base of prescribing eye care professionals,” said Mark Iwicki,
Chairman, President and Chief Executive Officer of Kala
Pharmaceuticals. “We are encouraged by the very positive feedback
we consistently receive from physicians and patients, who describe
EYSUVIS as an effective and comfortable medicine, and look forward
to building on this foundation as we continue with the EYSUVIS
launch. In parallel, we continue to promote INVELTYS and are
advancing our pipeline of new chemical entities for front and back
of the eye diseases, as we work to build a robust and sustainable
portfolio of innovative treatments.”
Second Quarter and Recent Business
Highlights:
EYSUVIS® (loteprednol etabonate ophthalmic suspension)
0.25%: EYSUVIS became commercially available in January
2021 as 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. Data from Symphony Health and the EYSUVIS patient hub
indicate that 15,632 EYSUVIS prescriptions were filled in the
second quarter of 2021, reflecting quarter-over-quarter growth of
93%. As of the week ended July 23, 2021, more than 28,000
prescriptions of EYSUVIS, written by more than 3,800 unique
prescribers, have been filled since the product launched in early
January 2021. Kala recently expanded its sales force from 91 to 105
ophthalmic sales professionals and expects a subsequent expansion
to 125 sales professionals by year-end, subject to continued growth
in payor coverage and the status of the COVID-19 pandemic.
As of the end of the second quarter of 2021, Kala has secured
coverage for more than 96 million commercial lives, which
represents approximately 56% of all commercially insured lives. In
February 2021, EYSUVIS was added to Express Scripts’ National
Preferred, Basic and High-Performance Formularies and in May 2021,
EYSUVIS was added to the Cigna and OptumRx commercial formularies.
Kala continues to engage in contract discussions with other
commercial health plans and expects to further expand formulary
coverage in the coming months.
In addition, as of July 1, 2021, EYSUVIS achieved 7% Medicare
Part D unrestricted market access, for a total of approximately 3.2
million covered Medicare Part D lives. Consistent with the
customary annual Medicare Part D bid cycle, contract negotiations
for 2022 coverage are ongoing with additional decisions anticipated
by the end of 2021.
INVELTYS® (loteprednol etabonate ophthalmic suspension)
1%: More than 41,000 INVELTYS prescriptions were reported
by Symphony Health in the second quarter of 2021, compared to
approximately 37,000 prescriptions reported in the first quarter of
2021. Kala believes that INVELTYS prescriptions and revenues will
grow over time as the number of ocular surgeries return to
pre-COVID levels. However, the Company is unable to project the
specific timing or quantify the specific potential impact on future
revenues given the continued uncertainty around the impact and
duration of the COVID-19 pandemic on elective procedures, which
includes ocular surgeries.
Development-Stage Pipeline: Kala is progressing
a pipeline of preclinical development programs targeted to address
front and back of the eye diseases. These programs, all of which
are new chemical entities (NCEs), include selective glucocorticoid
receptor modulators (SEGRMs), which are a novel class of therapies
designed to modify the downstream activity of the glucocorticoid
receptor to exhibit the anti-inflammatory and immunomodulatory
properties of corticosteroids while potentially avoiding the
typical safety concerns of steroids; and a receptor Tyrosine Kinase
Inhibitor program (rTKI) for the treatment of retinal diseases,
including wet age-related macular degeneration (wet AMD). Kala
owns all intellectual property and worldwide rights to these
pipeline candidates.
Financial Results:The financial results below
contain both GAAP and non-GAAP financial measures. The non-GAAP
financial measures exclude stock-based compensation expense, loss
on extinguishment of debt, non-cash interest expense and
depreciation and amortization. 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, 2021, Kala had
cash, cash equivalents and short-term investments of $149.6
million, compared to $153.5 million as of December 31, 2020. This
decrease primarily reflects cash used in operations, largely offset
by net proceeds of $40.7 million received from sales of common
stock under Kala’s at-the-market (ATM) offering program in the six
months ended June 30, 2021, and the release of $10 million in
restricted cash in connection with Kala’s repayment of its credit
facility with Athyrium following its entry into a loan agreement
with Oxford Finance. Kala anticipates that its cash resources as of
June 30, 2021, together with anticipated revenue from EYSUVIS and
INVELTYS, will enable it to fund its operations for at least two
years.
Second Quarter 2021 Financial Results
- Net Product Revenues: For the quarter ended
June 30, 2021, Kala reported net product revenues of $3.1 million,
consisting of $1.7 million of net revenues from EYSUVIS sales and
$1.4 million of net revenues from INVELTYS sales, compared to $0.8
million from INVELTYS sales for the same period in 2020.
- Cost of Product Revenues: For the quarter
ended June 30, 2021, cost of product revenues was $1.0 million,
compared to $0.8 million for the same period in 2020. Cost of
product revenues increased due to units of EYSUVIS sold as well as
the increase in total INVELTYS units sold during the quarter ended
June 30, 2021, compared to the same period in 2020, but was
partially offset by a reserve for excess INVELTYS inventory of $0.5
million recorded during the second quarter of 2020, which did not
occur during the same period in 2021. Non-GAAP cost of product
revenues was $1.0 million for the quarter ended June 30, 2021,
compared to $0.7 million for the same period in 2020.
- SG&A Expenses: For the quarter ended June
30, 2021, selling, general and administrative (SG&A) expenses
were $28.0 million, compared to $15.3 million for the same period
in 2020. The increase was primarily due to an increase in costs as
a result of the launch of EYSUVIS, including expansion of Kala’s
field sales force and stock-based compensation costs. Non-GAAP
SG&A expenses were $24.1 million for the quarter ended June 30,
2021, compared to $13.2 million for the same period in 2020.
- R&D Expenses: For the quarter ended June
30, 2021, research and development (R&D) expenses were $3.1
million, compared to $6.1 million for the same period in 2020. The
decrease was primarily due to costs incurred for STRIDE 3, Kala’s
Phase 3 clinical trial of EYSUVIS, during the second quarter of
2020 which were not incurred during the same period in 2021,
partially offset by increased spending on pipeline programs.
Non-GAAP R&D expenses were $2.1 million for the quarter ended
June 30, 2021, compared to $5.3 million for the same period in
2020.
- Operating Loss: For the quarter ended June 30,
2021, loss from operations was $29.0 million, compared to $21.3
million for the same period in 2020. Non-GAAP operating loss was
$24.1 million for the quarter ended June 30, 2021, compared to
$18.4 million for the same period in 2020.
- Net Loss: For the quarter ended June 30, 2021,
net loss was $36.5 million, or $0.57 per share, compared to a net
loss of $23.3 million, or $0.42 per share, for the same period in
2020. Non-GAAP net loss was $25.8 million for the quarter ended
June 30, 2021, compared to $20.2 million for the same period in
2020. The weighted average number of shares used to calculate net
loss per share was 64.6 million for the quarter ended June 30, 2021
and 55.7 million for the quarter ended June 30, 2020.
Financial Results for the Six Months ended June 30,
2021
- Net Product Revenues: For the six months ended
June 30, 2021, Kala reported net product revenues of $6.3 million,
consisting of $3.3 million of net revenues from EYSUVIS sales and
$3.0 million of net revenues from INVELTYS sales, compared to $1.9
million from INVELTYS sales for the same period in 2020.
- Cost of Product Revenues: For the six months
ended June 30, 2021, cost of product revenues was $1.8 million,
compared to $1.1 million for the same period in 2020. The increase
was primarily due to units of EYSUVIS sold as well as the increase
in total INVELTYS units sold during the six months ended June 30,
2021, compared to the same period in 2020, partially offset by a
reserve for excess INVELTYS inventory of $0.5 million recorded
during the six months ended June 30, 2020, which did not occur
during the same period in 2021. Non-GAAP cost of product revenues
was $1.7 million for the six months ended June 30, 2021, compared
to $1.1 million for the same period in 2020.
- SG&A Expenses: For the six months ended
June 30, 2021, SG&A expenses were $55.7 million, compared to
$30.7 million for the same period in 2020. The increase was
primarily due to an increase in costs as a result of the launch of
EYSUVIS, including expansion of Kala’s field sales force and
stock-based compensation costs. Non-GAAP SG&A expenses were
$47.9 million for the six months ended June 30, 2021, compared to
$26.7 million for the same period in 2020.
- R&D Expenses: For the six months ended
June 30, 2021, R&D expenses were $6.2 million, compared to
$11.5 million for the same period in 2020. The decrease was
primarily due to costs incurred for STRIDE 3, Kala’s Phase 3
clinical trial of EYSUVIS, during the six months ended June 30,
2020, which were not incurred during the same period in 2021,
partially offset by increased spending on pipeline programs.
Non-GAAP R&D expenses were $4.2 million for the six months
ended June 30, 2021, compared to $9.9 million for the same period
in 2020.
- Operating Loss: For the six months ended June
30, 2021, loss from operations was $57.4 million, compared to $41.4
million for the same period in 2020. Non-GAAP operating loss was
$47.4 million for the six months ended June 30, 2021, compared to
$35.8 million for the same period in 2020.
- Net Loss: For the six months ended June 30,
2021, net loss was $66.9 million, or $1.06 per share, compared to a
net loss of $45.3 million, or $0.94 per share, for the same period
in 2020. Non-GAAP net loss was $51.0 million for the six months
ended June 30, 2021, compared to $39.2 million for the same period
in 2020. The weighted average number of shares used to calculate
net loss per share was 63.1 million for the six months ended June
30, 2021, and 48.2 million for the six months ended June 30,
2020.
Conference Call Information:Kala will host a
live conference call and webcast today, August 5, 2021
at 8:00 a.m. ET to review its second quarter 2021
financial results. To access the conference call, please dial
866-300-4091 (domestic callers) or 703-736-7433 (international
callers) five minutes prior to the start of the call and provide
the conference ID: 3852499.
To access a subsequent archived recording of the call, please
visit the “Investors & Media” 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, loss on extinguishment of debt, non-cash interest expense
and depreciation and amortization. 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 EYSUVIS:EYSUVIS (loteprednol etabonate
ophthalmic suspension) 0.25% is approved for the short-term (up to
two weeks) treatment of the signs and symptoms of dry eye disease.
EYSUVIS utilizes Kala's AMPPLIFY® mucus-penetrating particle (MPP)
Drug Delivery Technology to enhance penetration of loteprednol
etabonate (LE) into target tissue of the ocular surface. In
preclinical studies, the AMPPLIFY Drug Delivery Technology
increased delivery of LE into target ocular tissues more than
three-fold compared to an active LE comparator by facilitating
penetration through the tear film mucins. EYSUVIS was approved by
the FDA on October 26, 2020. Kala believes that EYSUVIS' broad
mechanism of action, rapid onset of relief of both signs and
symptoms, favorable tolerability and safety profile and the
potential to be complementary to existing therapies, offer a
differentiated product profile for the short-term treatment of dry
eye disease, including the management of dry eye flares.
EYSUVIS, as with other ophthalmic corticosteroids, is
contraindicated in most viral diseases of the cornea and
conjunctiva including epithelial herpes simplex keratitis
(dendritic keratitis), vaccinia, and varicella, and also in
mycobacterial infection of the eye and fungal diseases of ocular
structures. The initial prescription and each renewal of the
medication order should be made by a physician only after
examination of the patient with the aid of magnification, such as
slit lamp biomicroscopy, and, where appropriate, fluorescein
staining. Prolonged use of corticosteroids may result in glaucoma
with damage to the optic nerve, as well as defects in visual acuity
and fields of vision. Corticosteroids should be used with caution
in the presence of glaucoma. Renewal of the medication order should
be made by a physician only after examination of the patient and
evaluation of the IOP. Use of corticosteroids may result in
posterior subcapsular cataract formation. Use of corticosteroids
may suppress the host response and thus increase the hazard of
secondary ocular infections. In acute purulent conditions,
corticosteroids may mask infection or enhance existing infection.
Use of a corticosteroid medication in the treatment of patients
with a history of herpes simplex requires great caution. Use of
ocular corticosteroids may prolong the course and may exacerbate
the severity of many viral infections of the eye (including herpes
simplex). Fungal infections of the cornea are particularly prone to
develop coincidentally with long-term local corticosteroid
application. Fungus invasion must be considered in any persistent
corneal ulceration where a corticosteroid has been used or is in
use. The most common adverse drug reaction following the use of
EYSUVIS for two weeks was instillation site pain, which was
reported in 5% of patients.
Please see full Prescribing Information at www.eysuvis.com
About INVELTYS:INVELTYS (loteprednol etabonate
ophthalmic suspension) 1% is a twice-a-day corticosteroid for the
treatment of post-operative inflammation and pain following ocular
surgery. INVELTYS utilizes Kala’s proprietary AMPPLIFY
mucus-penetrating particle (MPP) Drug Delivery Technology to
enhance penetration of loteprednol etabonate (LE) into target
tissues of the eye. In preclinical studies, the AMPPLIFY Drug
Delivery Technology increased delivery of LE into target ocular
tissues more than three-fold compared to an active LE comparator by
facilitating penetration through the tear film mucins. INVELTYS was
approved by the FDA on August 22, 2018. Kala
believes INVELTYS has a favorable profile for the treatment of
inflammation and pain following ocular surgery, due to its
twice-a-day dosing regimen.
INVELTYS, as with other ophthalmic corticosteroids, is
contraindicated in most viral diseases of the cornea and
conjunctiva including epithelial herpes simplex keratitis
(dendritic keratitis), vaccinia, and varicella, and also in
mycobacterial infection of the eye and fungal diseases of ocular
structures. A prolonged use of corticosteroids may result in
glaucoma with damage to the optic nerve, defects in visual acuity
and fields of vision. If this product is used for 10 days or
longer, IOP should be monitored. Use of corticosteroids may result
in posterior subcapsular cataract formation. Use of steroids after
cataract surgery may delay healing and increase the incidence of
bleb formation. In those diseases causing thinning of the cornea or
sclera, perforations have been known to occur with the use of
topical steroids. The initial prescription and renewal of the
medication order should be made by a physician only after
examination of the patient with the aid of magnification such as
slit lamp biomicroscopy and, where appropriate, fluorescein
staining. Prolonged use of corticosteroids may suppress the host
response and thus increase the hazard of secondary ocular
infections. In acute purulent conditions, steroids may mask
infection or enhance existing infection. Use of a corticosteroid
medication in the treatment of patients with a history of herpes
simplex requires great caution. Use of ocular steroids may prolong
the course and may exacerbate the severity of many viral infections
of the eye (including herpes simplex). Fungal infections of the
cornea are particularly prone to develop coincidentally with
long-term local steroid application. Fungus invasion must be
considered in any persistent corneal ulceration where a steroid has
been used or is in use. In clinical trials, the most common adverse
drug reactions were eye pain (1%) and posterior capsular
opacification (1%). These reactions may have been the consequence
of the surgical procedure.
Please see full Prescribing Information
at www.inveltys.com
About Kala Pharmaceuticals:
Kala is a commercial-stage biopharmaceutical company focused on
the discovery, development, and commercialization of innovative
therapies for diseases of the eye. Kala has applied its AMPPLIFY®
mucus-penetrating particle (MPP) Drug Delivery Technology to two
ocular therapies, EYSUVIS® (loteprednol etabonate ophthalmic
suspension) 0.25% for the short-term (up to two weeks) treatment of
signs and symptoms of dry eye disease and INVELTYS® (loteprednol
etabonate ophthalmic suspension) 1% for the treatment of
post-operative inflammation and pain following ocular surgery. The
Company also has a pipeline of pre-clinical development programs
targeted to address unmet medical needs, including both front and
back of the eye diseases. 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, including statements regarding
the Company’s plans to expand its sales force, subject to continued
growth in payor coverage and the status of the COVID-19 pandemic,
the Company’s expectations regarding an increase in payor coverage
for EYSUVIS and INVELTYS, the Company’s expectations regarding the
growth in EYSUVIS and INVELTYS prescriptions and revenue over time,
the Company progressing its pipeline of preclinical development
programs targeted to address front and back of the eye diseases,
and the Company’s expectations regarding its use of cash, cash
runway and anticipated revenues. All statements, other than
statements of historical facts, contained in this press release,
including statements regarding the Company’s strategy, future
operations, future financial position, future revenue, projected
costs, prospects, plans and objectives of management, are
forward-looking statements. The words “anticipate,” “believe,”
“continue” “could,” “estimate,” “expect,” “intend,” “may,” “plan,”
“potential,” “predict,” “project,” “should,” “target,” “will,”
“would,” and similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. The Company may not
actually achieve the plans, intentions or expectations disclosed in
its forward-looking statements, and you should not place undue
reliance on such forward-looking statements. Actual results or
events could differ materially from the plans, intentions and
expectations disclosed in the forward-looking statements as a
result of various risks and uncertainties including, but not
limited to: the impact of extraordinary external events, such as
the current pandemic health event resulting from the novel
coronavirus (COVID-19), and their collateral consequences,
including disruption of the activities of the Company’s sales force
and the market for EYSUVIS and INVELTYS; whether the Company will
be able to successfully implement its commercialization plans for
EYSUVIS and INVELTYS; whether the market opportunity for EYSUVIS
and INVELTYS is consistent with the Company’s expectations and
market research; the Company’s ability execute on the commercial
launch of EYSUVIS on the timeline expected, or at all, including
obtaining and increasing Commercial and Medicare Part D payor
coverage; whether the Company will be able to generate its
projected net product revenue on the timeline expected, or at all;
whether the Company's cash resources will be sufficient to fund the
Company's foreseeable and unforeseeable operating expenses and
capital expenditure requirements for the Company's expected
timeline; other matters that could affect the availability or
commercial potential of EYSUVIS and INVELTYS; and other important
factors, any of which could cause the Company's actual results to
differ from those contained in the forward-looking statements,
discussed in the “Risk Factors” section of the Company’s Annual
Report on Form 10-K, most recently filed Quarterly Report on Form
10-Q and other filings the Company makes with the Securities and
Exchange Commission. These forward-looking statements represent the
Company’s views as of the date of this release and should not be
relied upon as representing the Company’s views as of any date
subsequent to the date hereof. The Company 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.
Investors:Jill
Steierjill.steier@kalarx.com781-810-4086
Hannah Deresiewiczhannah.deresiewicz@sternir.com212-362-1200
Financial Tables
Kala Pharmaceuticals, Inc. |
Balance Sheet Data |
(in thousands) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2021 |
|
|
2020 |
Cash,
cash equivalents and short-term investments |
|
|
$ |
149,635 |
|
|
$ |
153,540 |
Total
assets |
|
|
|
215,464 |
|
|
|
221,606 |
Working capital (1) |
|
|
|
145,644 |
|
|
|
149,154 |
Long-term debt, net of
discounts |
|
|
|
78,055 |
|
|
|
72,243 |
Other long-term
liabilities |
|
|
|
27,063 |
|
|
|
27,143 |
Total
stockholders’ equity |
|
|
|
84,270 |
|
|
|
99,995 |
(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, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues, net |
|
|
$ |
3,051 |
|
|
$ |
833 |
|
|
$ |
6,317 |
|
|
$ |
1,904 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs
and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenues |
|
|
|
1,016 |
|
|
|
759 |
|
|
|
1,771 |
|
|
|
1,113 |
|
Selling, general and administrative |
|
|
|
27,986 |
|
|
|
15,301 |
|
|
|
55,685 |
|
|
|
30,709 |
|
Research and development |
|
|
|
3,094 |
|
|
|
6,053 |
|
|
|
6,220 |
|
|
|
11,487 |
|
Total operating expenses |
|
|
|
32,096 |
|
|
|
22,113 |
|
|
|
63,676 |
|
|
|
43,309 |
|
Loss
from operations |
|
|
|
(29,045 |
) |
|
|
(21,280 |
) |
|
|
(57,359 |
) |
|
|
(41,405 |
) |
Other
income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
|
33 |
|
|
|
102 |
|
|
|
76 |
|
|
|
400 |
|
Interest expense |
|
|
|
(2,091 |
) |
|
|
(2,134 |
) |
|
|
(4,232 |
) |
|
|
(4,262 |
) |
Loss on extinguishment of debt |
|
|
|
(5,395 |
) |
|
|
— |
|
|
|
(5,395 |
) |
|
|
— |
|
Net loss |
|
|
|
(36,498 |
) |
|
|
(23,312 |
) |
|
|
(66,910 |
) |
|
|
(45,267 |
) |
Net
loss per share attributable to common stockholders—basic and
diluted |
|
|
$ |
(0.57 |
) |
|
$ |
(0.42 |
) |
|
$ |
(1.06 |
) |
|
$ |
(0.94 |
) |
Weighted average shares outstanding—basic and diluted |
|
|
|
64,554,506 |
|
|
|
55,703,882 |
|
|
|
63,113,194 |
|
|
|
48,232,933 |
|
Kala Pharmaceuticals, Inc. |
|
Reconciliation of GAAP to Non-GAAP Financial
Measures |
|
(In thousands) |
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2021 |
|
|
2020 |
|
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss (GAAP) |
|
|
$ |
(36,498 |
) |
|
$ |
(23,312 |
) |
|
|
$ |
(66,910 |
) |
|
$ |
(45,267 |
) |
Add-back: stock-based
compensation expense |
|
|
|
4,710 |
|
|
|
2,648 |
|
|
|
|
9,412 |
|
|
|
5,143 |
|
Add-back: non-cash
interest |
|
|
|
367 |
|
|
|
260 |
|
|
|
|
645 |
|
|
|
513 |
|
Add-back: depreciation and
amortization |
|
|
|
256 |
|
|
|
224 |
|
|
|
|
504 |
|
|
|
454 |
|
Add-back: loss on
extinguishment of debt |
|
|
|
5,395 |
|
|
|
— |
|
|
|
|
5,395 |
|
|
|
— |
|
Non-GAAP net loss |
|
|
$ |
(25,770 |
) |
|
$ |
(20,180 |
) |
|
|
$ |
(50,954 |
) |
|
$ |
(39,157 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenues
(GAAP) |
|
|
$ |
1,016 |
|
|
$ |
759 |
|
|
|
$ |
1,771 |
|
|
$ |
1,113 |
|
Less: stock-based compensation
expense |
|
|
|
37 |
|
|
|
9 |
|
|
|
|
71 |
|
|
|
28 |
|
Less: depreciation and
amortization |
|
|
|
13 |
|
|
|
13 |
|
|
|
|
26 |
|
|
|
26 |
|
Non-GAAP cost of product
revenues |
|
|
$ |
966 |
|
|
$ |
737 |
|
|
|
$ |
1,674 |
|
|
$ |
1,059 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative expenses (GAAP) |
|
|
$ |
27,986 |
|
|
$ |
15,301 |
|
|
|
$ |
55,685 |
|
|
$ |
30,709 |
|
Less: stock-based compensation
expense |
|
|
|
3,687 |
|
|
|
1,933 |
|
|
|
|
7,389 |
|
|
|
3,686 |
|
Less: depreciation and
amortization |
|
|
|
187 |
|
|
|
150 |
|
|
|
|
368 |
|
|
|
300 |
|
Non-GAAP selling, general and
administrative expenses |
|
|
$ |
24,112 |
|
|
$ |
13,218 |
|
|
|
$ |
47,928 |
|
|
$ |
26,723 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
expenses (GAAP) |
|
|
$ |
3,094 |
|
|
$ |
6,053 |
|
|
|
$ |
6,220 |
|
|
$ |
11,487 |
|
Less: stock-based compensation
expense |
|
|
|
986 |
|
|
|
706 |
|
|
|
|
1,952 |
|
|
|
1,429 |
|
Less: depreciation and
amortization |
|
|
|
56 |
|
|
|
61 |
|
|
|
|
110 |
|
|
|
128 |
|
Non-GAAP research and
development expenses |
|
|
$ |
2,052 |
|
|
$ |
5,286 |
|
|
|
$ |
4,158 |
|
|
$ |
9,930 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating loss
(GAAP) |
|
|
$ |
(29,045 |
) |
|
$ |
(21,280 |
) |
|
|
$ |
(57,359 |
) |
|
$ |
(41,405 |
) |
Add-back: stock-based
compensation expense |
|
|
|
4,710 |
|
|
|
2,648 |
|
|
|
|
9,412 |
|
|
|
5,143 |
|
Add-back: depreciation and
amortization |
|
|
|
256 |
|
|
|
224 |
|
|
|
|
504 |
|
|
|
454 |
|
Non-GAAP total operating
loss |
|
|
$ |
(24,079 |
) |
|
$ |
(18,408 |
) |
|
|
$ |
(47,443 |
) |
|
$ |
(35,808 |
) |
KALA BIO (NASDAQ:KALA)
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