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 third quarter ended
September 30, 2021 and provided a corporate update.
“We have made progress toward our goal of providing patients and
physicians with a portfolio of innovative medicines and product
candidates that can better treat diseases of the front and back of
the eye,” said Mark Iwicki, Chief Executive Officer of Kala. “We
continue to receive positive feedback from physicians and patients
on EYSUVIS and saw 19% prescription growth in the third quarter
compared to the prior quarter. In parallel, we continue to invest
in advancing our pipeline and today announced the acquisition of
Combangio and its lead product candidate, now known as KPI-012, a
novel biologic for the treatment of rare ocular surface diseases.
We believe that together with our rTKI and SEGRM programs, KPI-012
will serve as a key foundation for our long-term growth. We look
forward to submitting an investigational new drug application to
the U.S. Food and Drug Administration for KPI-012 and, subject to
regulatory clearance, initiating a Phase 2/3 trial for persistent
corneal epithelial defect in the third quarter of 2022.”
Third 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 18,537 EYSUVIS prescriptions were filled in the third
quarter of 2021, representing quarter-over-quarter growth of 19%.
As of the week ended November 5, 2021, 50,862 prescriptions of
EYSUVIS, including over 6,652 refill prescriptions, written by more
than 5,502 unique prescribers, have been filled since the product
launched in early January 2021.
As of the end of the third quarter of 2021, Kala has secured
coverage for more than 99 million commercial lives, which
represents approximately 60% of all commercially insured lives. In
the third quarter, EYSUVIS added an additional 4.5 million covered
lives through health plans and existing contracts with Express
Scripts and OptumRx. 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 the end of the third quarter of 2021, EYSUVIS
achieved 10% Medicare Part D coverage, an increase of 3% for the
quarter and total coverage for EYSUVIS is 4.5 million Medicare Part
D lives.
INVELTYS® (loteprednol etabonate ophthalmic suspension)
1%: 37,410 INVELTYS prescriptions were reported by
Symphony Health in the third quarter of 2021, compared to 41,103
prescriptions reported in the second quarter of 2021. INVELTYS
prescriptions declined in the quarter due to continued weakness in
the ocular surgery market from COVID-19 as well as the removal of
INVELTYS from the CVS/Caremark formulary coverage list. Kala
believes that INVELTYS prescriptions and revenues will return to
growth 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: In a separate press
release issued today, Kala announced the acquisition of Combangio,
Inc., a private, clinical-stage company developing a novel
investigational secretome therapy, now known as KPI-012, to address
the complex wound healing process in persistent corneal epithelial
defect (PCED) and other severe ocular diseases driven by impaired
corneal healing. KPI-012 is initially in clinical development for
the treatment of PCED, a rare disease with an estimated incidence
in the U.S. of 100,000 cases per year and 238,000 cases per year in
the U.S., E.U. and Japan combined, and has received Orphan
Designation for the treatment of PCED by the U.S. Food and Drug
Administration (FDA). Kala plans to submit an investigational new
drug (IND) application to FDA for KPI-012 and, subject to
regulatory clearance, initiate a Phase 2/3 trial of KPI-012 in the
third quarter of 2022.
In addition, Kala continues to progress its development programs
targeted to address front and back of the eye diseases. These
programs, all of which are new chemical entities (NCEs), include a
receptor Tyrosine Kinase Inhibitor candidate (rTKI), KPI-287, and
selective glucocorticoid receptor modulators (SEGRMs). KPI-287 is
administered via suprachoroidal delivery for the treatment of
retinal diseases, including wet age-related macular degeneration
(wet AMD). Kala expects to announce preclinical pharmacokinetics
and efficacy data in the first quarter of 2022.
SEGRMs 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. Kala expects to determine a development
candidate in the first half of 2022. Kala owns all intellectual
property and worldwide rights to its 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 September 30, 2021, Kala
had cash and cash equivalents of $124.5 million, compared to $149.6
million of cash, cash equivalents and short-term investments as of
June 30, 2021. This decrease primarily reflects cash used in
operations. Cash and cash equivalents as of September 30, 2021 do
not reflect the $5 million paid as upfront consideration for the
acquisition of Combangio, which was announced in a separate press
release this morning. Based on its current plans, including the
costs to acquire Combangio and develop KPI-012, Kala anticipates
that its cash resources as of September 30, 2021, together with
anticipated revenue from EYSUVIS and INVELTYS and certain cost
containment measures, will enable it to fund its operations until
the second quarter of 2023.
Third Quarter 2021 Financial Results
- Net Product Revenues: For the quarter ended
September 30, 2021, Kala reported net product revenues of $3.1
million, consisting of $1.83 million of net revenues from EYSUVIS
sales and $1.24 million of net revenues from INVELTYS sales,
compared to $2.2 million from INVELTYS sales for the same period in
2020.
- Cost of Product Revenues: For the quarter
ended September 30, 2021, cost of product revenues was $0.9
million, compared to $0.7 million for the same period in 2020. Cost
of product revenues increased due to units of EYSUVIS sold.
Non-GAAP cost of product revenues was $0.9 million for the quarter
ended September 30, 2021, compared to $0.7 million for the same
period in 2020.
- SG&A Expenses: For the quarter ended
September 30, 2021, selling, general and administrative (SG&A)
expenses were $25.3 million, compared to $23.9 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. Non-GAAP SG&A expenses were $22.1
million for the quarter ended September 30, 2021, compared to $20.5
million for the same period in 2020.
- R&D Expenses: For the quarter ended
September 30, 2021, research and development (R&D) expenses
were $2.9 million, compared to $3.5 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 as well as other costs
related to EYSUVIS that were expensed as research and development,
during the third 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 $2.0 million for
the quarter ended September 30, 2021, compared to $2.4 million for
the same period in 2020.
- Operating Loss: For the quarter ended
September 30, 2021, loss from operations was $26.1 million,
compared to $25.8 million for the same period in 2020. Non-GAAP
operating loss was $21.9 million for the quarter ended September
30, 2021, compared to $21.4 million for the same period in
2020.
- Net Loss: For the quarter ended September 30,
2021, net loss was $28.1 million, or $0.43 per share, compared to a
net loss of $27.9 million, or $0.50 per share, for the same period
in 2020. Non-GAAP net loss was $23.5 million for the quarter ended
September 30, 2021, compared to $23.2 million for the same period
in 2020. The weighted average number of shares used to calculate
net loss per share was 65.1 million for the quarter ended September
30, 2021 and 56.0 million for the quarter ended September 30,
2020.
Financial Results for the Nine Months ended September
30, 2021
- Net Product Revenues: For the nine months
ended September 30, 2021, Kala reported net product revenues of
$9.4 million, consisting of $5.1 million of net revenues from
EYSUVIS sales and $4.3 million of net revenues from INVELTYS sales,
compared to $4.1 million of net revenue from INVELTYS sales for the
same period in 2020.
- Cost of Product Revenues: For the nine months
ended September 30, 2021, cost of product revenues was $2.7
million, compared to $1.8 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 nine months ended
September 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 nine months ended September 30, 2020, which did
not occur during the same period in 2021. Non-GAAP cost of product
revenues was $2.5 million for the nine months ended September 30,
2021, compared to $1.7 million for the same period in 2020.
- SG&A Expenses: For the nine months ended
September 30, 2021, selling, general and administrative (SG&A)
expenses were $81.0 million, compared to $54.6 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 $70.1 million for the nine months
ended September 30, 2021, compared to $47.2 million for the same
period in 2020.
- R&D Expenses: For the nine months ended
September 30, 2021, R&D expenses were $9.1 million, compared to
$15.0 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 nine months ended September
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 $6.1 million for the nine months
ended September 30, 2021, compared to $12.5 million for the same
period in 2020.
- Operating Loss: For the nine months ended
September 30, 2021, loss from operations was $83.4 million,
compared to $67.2 million for the same period in 2020. Non-GAAP
operating loss was $69.3 million for the nine months ended
September 30, 2021, compared to $57.3 million for the same period
in 2020.
- Net Loss: For the nine months ended September
30, 2021, net loss was $95.0 million, or $1.49 per share, compared
to a net loss of $73.2 million, or $1.44 per share, for the same
period in 2020. Non-GAAP net loss was $74.5 million for the nine
months ended September 30, 2021, compared to $62.5 million for the
same period in 2020. The weighted average number of shares used to
calculate net loss per share was 63.8 million for the nine months
ended September 30, 2021, and 50.9 million for the nine months
ended September 30, 2020.
Conference Call Information:Kala will host a
live conference call and webcast today, November 15, 2021
at 10:30 a.m. ET to review its third quarter 2021
financial results, as well as its acquisition of Combangio, which
was announced in a separate press release this morning. To access
the live 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:
7298039.
To access the live webcast, which will include a slide
presentation, 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, 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 development programs including a
clinical-stage secretome product candidate initially targeting
persistent corneal epithelial defects (PCED) and multiple
proprietary NCE preclinical development programs targeted to
address unmet medical needs, including both front and back of the
eye diseases. Kala plans to submit an investigational new drug
application with the FDA for KPI-012 and, subject to regulatory
clearance, commence a Phase 2/3 clinical trial for PCED in the
United States in third quarter of 2022. 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 acquisition of
Combangio and the other transactions contemplated by the
acquisition of Combangio and any other statements about future
expectations, prospects, estimates and other matters that are
dependent upon future events or developments, including statements
related to Kala’s expectations with respect to the potential
financial impact and benefits of the acquisition of Combangio,
expectations with respect to potential advantages of KPI-012, the
future development or commercialization of KPI-012, conduct and
timelines of clinical trials, the clinical utility of KPI-012 for
PCEDs, plans for regulatory filings, the market opportunity for
KPI-012 for PCEDs and other indications, plans to pursue research
and development of KPI-012 for other indications, expectations
regarding the growth in EYSUVIS and INVELTYS prescriptions and
revenue over time, estimates regarding anticipated product revenue
and planned cost containment measures, Kala’s plans to progress its
pipeline of preclinical development programs targeted to address
front and back of the eye diseases, 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
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 Kala’s sales force and the market for EYSUVIS
and INVELTYS; whether Kala will be able to successfully implement
its commercialization plans for EYSUVIS and INVELTYS; whether the
market opportunity for EYSUVIS and INVELTYS is consistent with
Kala’s expectations and market research; Kala’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 Kala will be able to generate its
projected net product revenue on the timeline expected, or at all;
Kala’s ability to realize the anticipated benefits of the
acquisition of Combangio, including the possibility that the
expected benefits, synergies and growth prospects from the
acquisition of Combangio will not be realized or will not be
realized within the expected time period or at all, negative
effects of the announcement of the acquisition of Combangio on the
market price of Kala’s common stock, significant transaction costs,
unknown liabilities, the risk of litigation and/or regulatory
actions related to the acquisition of Combangio, the uncertainties
inherent in the initiation and conduct of clinical trials,
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,
whether regulatory or commercial milestones are achieved, Kala’s
ability to successfully integrate Combangio’s business into its
business, Kala’s ability to retain and hire key personnel, the risk
that disruption resulting from the acquisition of Combangio may
adversely affect its business and business relationships, including
with employees and suppliers, 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 the Company’s views as of the
date of this 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.
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) |
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
2021 |
|
|
2020 |
Cash, cash equivalents and
short-term investments |
$ |
124,503 |
|
|
$ |
153,540 |
Total assets |
|
193,814 |
|
|
|
221,606 |
Working capital (1) |
|
121,891 |
|
|
|
149,154 |
Long-term debt, net of
discounts |
|
78,491 |
|
|
|
72,243 |
Other long-term
liabilities |
|
26,659 |
|
|
|
27,143 |
Total stockholders’
equity |
|
61,469 |
|
|
|
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 |
|
Nine Months Ended |
|
September 30, |
|
September 30, |
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
Product revenues, net |
$ |
3,067 |
|
|
$ |
2,220 |
|
|
$ |
9,384 |
|
|
$ |
4,124 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenues |
|
908 |
|
|
|
701 |
|
|
|
2,679 |
|
|
|
1,814 |
|
Selling, general and administrative |
|
25,349 |
|
|
|
23,893 |
|
|
|
81,034 |
|
|
|
54,602 |
|
Research and development |
|
2,881 |
|
|
|
3,468 |
|
|
|
9,101 |
|
|
|
14,955 |
|
Total operating expenses |
|
29,138 |
|
|
|
28,062 |
|
|
|
92,814 |
|
|
|
71,371 |
|
Loss from operations |
|
(26,071 |
) |
|
|
(25,842 |
) |
|
|
(83,430 |
) |
|
|
(67,247 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
16 |
|
|
|
51 |
|
|
|
92 |
|
|
|
451 |
|
Interest expense |
|
(2,072 |
) |
|
|
(2,157 |
) |
|
|
(6,304 |
) |
|
|
(6,419 |
) |
Loss on extinguishment of debt |
|
— |
|
|
|
— |
|
|
|
(5,395 |
) |
|
|
— |
|
Net loss |
|
(28,127 |
) |
|
|
(27,948 |
) |
|
|
(95,037 |
) |
|
|
(73,215 |
) |
Net loss per share
attributable to common stockholders—basic and diluted |
$ |
(0.43 |
) |
|
$ |
(0.50 |
) |
|
$ |
(1.49 |
) |
|
$ |
(1.44 |
) |
Weighted average shares
outstanding—basic and diluted |
|
65,050,481 |
|
|
|
56,030,717 |
|
|
|
63,766,052 |
|
|
|
50,851,167 |
|
|
|
|
|
Kala Pharmaceuticals, Inc. |
Reconciliation of GAAP to Non-GAAP Financial
Measures |
(In thousands) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
September 30, |
|
|
September 30, |
|
2021 |
|
|
2020 |
|
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss (GAAP) |
$ |
(28,127 |
) |
|
$ |
(27,948 |
) |
|
|
$ |
(95,037 |
) |
|
$ |
(73,215 |
) |
Add-back: stock-based
compensation expense |
|
3,928 |
|
|
|
4,261 |
|
|
|
|
13,340 |
|
|
|
9,249 |
|
Add-back: non-cash
interest |
|
435 |
|
|
|
269 |
|
|
|
|
1,080 |
|
|
|
782 |
|
Add-back: depreciation and
amortization |
|
259 |
|
|
|
220 |
|
|
|
|
763 |
|
|
|
674 |
|
Add-back: loss on
extinguishment of debt |
|
— |
|
|
|
— |
|
|
|
|
5,395 |
|
|
|
— |
|
Non-GAAP net loss |
$ |
(23,505 |
) |
|
$ |
(23,198 |
) |
|
|
$ |
(74,459 |
) |
|
$ |
(62,510 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenues
(GAAP) |
$ |
908 |
|
|
$ |
701 |
|
|
|
$ |
2,679 |
|
|
$ |
1,814 |
|
Less: stock-based compensation
expense |
|
38 |
|
|
|
32 |
|
|
|
|
109 |
|
|
|
60 |
|
Less: depreciation and
amortization |
|
13 |
|
|
|
13 |
|
|
|
|
39 |
|
|
|
39 |
|
Non-GAAP cost of product
revenues |
$ |
857 |
|
|
$ |
656 |
|
|
|
$ |
2,531 |
|
|
$ |
1,715 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative expenses (GAAP) |
$ |
25,349 |
|
|
$ |
23,893 |
|
|
|
$ |
81,034 |
|
|
$ |
54,602 |
|
Less: stock-based compensation
expense |
|
3,021 |
|
|
|
3,244 |
|
|
|
|
10,410 |
|
|
|
6,930 |
|
Less: depreciation and
amortization |
|
185 |
|
|
|
150 |
|
|
|
|
553 |
|
|
|
450 |
|
Non-GAAP selling, general and
administrative expenses |
$ |
22,143 |
|
|
$ |
20,499 |
|
|
|
$ |
70,071 |
|
|
$ |
47,222 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
expenses (GAAP) |
$ |
2,881 |
|
|
$ |
3,468 |
|
|
|
$ |
9,101 |
|
|
$ |
14,955 |
|
Less: stock-based compensation
expense |
|
869 |
|
|
|
985 |
|
|
|
|
2,821 |
|
|
|
2,259 |
|
Less: depreciation and
amortization |
|
61 |
|
|
|
57 |
|
|
|
|
171 |
|
|
|
185 |
|
Non-GAAP research and
development expenses |
$ |
1,951 |
|
|
$ |
2,426 |
|
|
|
$ |
6,109 |
|
|
$ |
12,511 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating loss
(GAAP) |
$ |
(26,071 |
) |
|
$ |
(25,842 |
) |
|
|
$ |
(83,430 |
) |
|
$ |
(67,247 |
) |
Add-back: stock-based
compensation expense |
|
3,928 |
|
|
|
4,261 |
|
|
|
|
13,340 |
|
|
|
9,249 |
|
Add-back: depreciation and
amortization |
|
259 |
|
|
|
220 |
|
|
|
|
763 |
|
|
|
674 |
|
Non-GAAP total operating
loss |
$ |
(21,884 |
) |
|
$ |
(21,361 |
) |
|
|
$ |
(69,327 |
) |
|
$ |
(57,324 |
) |
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