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 fourth quarter and full
year ended December 31, 2021 and provided a corporate update.
“In recent months, we have made meaningful progress toward our
goal of establishing EYSUVIS as the preferred first line
prescription therapy for mild or moderate dry eye disease, and we
are pleased to report a 21% increase in prescriptions for the
fourth quarter of 2021 relative to the prior quarter,” said Mark
Iwicki, Chairman and Chief Executive Officer of Kala. “We believe
this prescription growth is a positive indicator and will be
enhanced by our recently launched direct-to-consumer marketing
campaign, as well as expanded commercial and Medicare coverage,
which together now account for over 125 million total lives.”
Mr. Iwicki continued, “In parallel, we continue to progress our
portfolio of innovative medicines for diseases of the front and
back of the eye, including KPI-012, our novel investigational
secretome therapy, and KPI-287, our potent and selective tyrosine
kinase inhibitor candidate. We look forward to sharing data from
the completed Phase 1b clinical trial of KPI-012 at the ARVO Annual
Meeting in the second quarter and expect to initiate our Phase 2/3
development program in the fourth quarter of 2022, as we advance
KPI-012 to address the unmet needs in persistent corneal epithelial
defect (PCED) and additional indications.”
Fourth Quarter and Recent Business
Highlights:
Commercial Portfolio:
EYSUVIS® (loteprednol etabonate ophthalmic suspension)
0.25%: EYSUVIS became commercially available in January
2021 as the first and only U.S. Food and Drug Administrative (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 indicate that 22,460 EYSUVIS prescriptions were filled in
the fourth quarter of 2021, representing quarter-over-quarter
growth of 21%. EYSUVIS prescription growth has continued in the
first quarter of 2022. As of the week ended March 18, 2022, 86,969
prescriptions of EYSUVIS, including over 14,533 refill
prescriptions, written by more than 7,400 unique prescribers, have
been filled since the product launched in January 2021.
Kala has secured coverage for more than 118 million commercial
lives, which represents approximately 70% of all commercially
insured lives. This includes coverage under UnitedHealthcare, one
of the largest commercial health care plans in the United States,
which became effective in March 2022. In addition, Kala has secured
coverage for 7.1 million Medicare lives, which represents
approximately 15% of all Medicare-insured lives. This includes
coverage under Cigna Medicare, which added EYSUVIS as a preferred
brand in February 2022. Kala continues to engage in contract
discussions with other health plans and expects to further expand
formulary coverage in the first half of 2022.
INVELTYS® (loteprednol etabonate ophthalmic suspension)
1%: 36,695 INVELTYS prescriptions were reported by
Symphony Health in the fourth quarter of 2021, compared to 37,410
prescriptions reported in the third quarter of 2021. Kala believes
that INVELTYS prescriptions and revenues will return to growth as
the number of ocular surgeries return to pre-COVID levels and as
Medicare Part D coverage for the product increases.
Development-Stage Pipeline:
Kala is progressing a pipeline of clinical and preclinical
programs addressing important unmet needs in ophthalmology:
KPI-012: KPI-012 is a novel cell-free secretome
therapy containing biomolecules secreted by human bone marrow
derived mesenchymal stem cells that has the potential for multiple
therapeutic applications. The combination of growth factors,
protease inhibitors, matrix proteins and neurotrophic factors in
KPI-012 has the potential to correct the impaired corneal healing
that is an underlying etiology of diseases such as persistent
corneal epithelial defect (PCED), the first indication that Kala is
pursuing, and other severe ocular diseases driven by impaired
healing. A Phase 1b clinical trial in PCED patients demonstrated
significant improvement in seven of the eight PCED patients treated
and complete healing in six of eight of the patients, in most cases
within 1-2 weeks of initiation of twice-daily (BID) dosing. Kala
plans to submit an investigational new drug (IND) application to
the FDA for KPI-012 and, subject to regulatory clearance, initiate
a Phase 2/3 clinical trial of KPI-012 in PCED patients in the
fourth quarter of 2022. Kala believes the multifactorial mechanism
of action of KPI-012 also makes it a platform technology and is
evaluating KPI-012 for potential expansion
to indications for rare front of the eye diseases,
such as limbal stem cell deficiency, chemical burns and Sjogren’s
Syndrome, as well as select rare back of the eye diseases,
such as retinitis pigmentosa and optic neuritis.
A poster presentation detailing the results of the previously
completed Phase 1b clinical trial of KPI-012 in patients with PCED
has been accepted for presentation at the Association for Research
in Vision and Ophthalmology (ARVO) Annual Meeting, which will be
held from May 1-4, 2022 in Denver, Colorado and virtually from May
11-12, 2022.
KPI-287: KPI-287 is a suprachoroidal tyrosine
kinase inhibitor (TKI) candidate for the treatment of retinal
diseases such as wet age-related macular degeneration and diabetic
macular edema. Preclinical studies are ongoing to evaluate
pharmacokinetics and efficacy over six months to evaluate the
potential for sustained delivery and inhibition of VEGF-induced
pathology. Kala plans to provide updates on this program throughout
2022.
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, loss on extinguishment of debt,
acquired in-process research and development, gain on fair value
remeasurement of deferred purchase consideration, transaction costs
related to the acquisition of Combangio, and the impact of the
termination of the lease for the Company’s former corporate
headquarters. 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, 2021, Kala
had cash and cash equivalents of $92.1 million, compared to $124.5
million of cash, cash equivalents and short-term investments as of
September 30, 2021. This decrease primarily reflects cash used in
operations, as well as the $5 million paid as upfront consideration
for the acquisition of Combangio, which closed in the fourth
quarter of 2021. Based on its current plans, Kala anticipates that
its cash resources as of December 31, 2021, together with
anticipated revenue from EYSUVIS and INVELTYS, will enable it to
fund its operations into the second quarter of 2023.
Fourth Quarter 2021 Financial Results:
- Net Product Revenues: For the quarter ended
December 31, 2021, Kala reported net product revenues of $1.9
million, consisting of $1.2 million of net revenues from EYSUVIS
sales and $0.7 million of net revenues from INVELTYS sales,
compared to net product revenues of $2.2 million, consisting of
$0.3 million of net revenues from EYSUVIS sales and $1.9 million of
net revenues from INVELTYS sales, for the same period in 2020. The
increase of $0.9 million in net revenue from the sales of EYSUVIS
in the fourth quarter of 2021 compared to the same period in 2020
is due to the commencement of the full commercial launch of EYSUVIS
beginning in January 2021. The decrease of $1.2 million in net
revenue from sales of INVELTYS for the fourth quarter of 2021
compared to the fourth quarter of 2020 is primarily the result of
increased product returns.
- Cost of Product Revenues: For the quarter
ended December 31, 2021, cost of product revenues was $1.4 million,
consistent with the same period in 2020. Non-GAAP cost of product
revenues was $1.3 million for the quarter ended December 31, 2021,
consistent with the same period in 2020.
- SG&A Expenses: For the quarter ended
December 31, 2021, selling, general and administrative (SG&A)
expenses were $24.0 million, compared to $26.5 million for the same
period in 2020. The decrease was primarily due to decreases in
professional service fees, external sales and marketing costs and
stock compensation. Non-GAAP SG&A expenses were $21.5 million
for the quarter ended December 31, 2021, compared to $23.1 million
for the same period in 2020.
- R&D Expenses: For the quarter ended
December 31, 2021, research and development (R&D) expenses were
$2.4 million, compared to $3.4 million for the same period in 2020.
The decrease was primarily due to decreased employee-related costs,
such as stock compensation expense, in the quarter ended December
31, 2021 as compared to the same period in 2020, partially offset
by increased spending on pipeline programs. Non-GAAP R&D
expenses were $2.0 million for the quarter ended December 31, 2021,
compared to $2.5 million for the same period in 2020.
- Acquired IPR&D Expenses: For the quarter
ended December 31, 2021, acquired in-process R&D expenses
(IPR&D) were $26.6 million. Acquired IPR&D for the quarter
ended December 31, 2021 are costs associated with
the acquisition of acquired IPR&D assets from
Combangio. There were no acquired IPR&D expenses for the
same period in 2020. Non-GAAP operating loss and net loss exclude
acquired IPR&D expenses.
- Gain on Fair Value Remeasurement of Deferred Purchase
Consideration: For the quarter ended December 31, 2021,
the gain on fair value remeasurement of deferred purchase
consideration, in connection with the Combangio acquisition, was
$5.8 million. There was no gain or loss on fair value remeasurement
of deferred purchase consideration for the same period in 2020.
Non-GAAP operating loss and net loss exclude the gain on fair value
remeasurement of deferred purchase consideration.
- Operating Loss: For the quarter ended December
31, 2021, loss from operations was $46.8 million, compared to $29.0
million for the same period in 2020. Non-GAAP operating loss was
$23.0 million for the quarter ended December 31, 2021, compared to
$24.7 million for the same period in 2020.
- Net Loss: For the quarter ended December 31,
2021, net loss was $47.6 million, or $0.68 per share, compared to a
net loss of $31.1 million, or $0.55 per share, for the same period
in 2020. Non-GAAP net loss was $24.6 million for the quarter ended
December 31, 2021, compared to $26.5 million for the same period in
2020. The weighted average number of shares used to calculate net
loss per share was 69.5 million for the quarter ended December 31,
2021 and 56.9 million for the quarter ended December 31, 2020.
Financial Results for the Full Year Ended December 31,
2021:
- Net Product Revenues: For the full year ended
December 31, 2021, Kala reported net product revenues of $11.2
million, consisting of $6.3 million of net revenues from EYSUVIS
sales and $4.9 million of net revenues from INVELTYS sales,
compared to net product revenues of $6.4 million, consisting of
$0.3 million of net revenues from EYSUVIS sales and $6.1 million of
net revenues from INVELTYS sales, for the same period in 2020. The
increase of $6.0 million in net revenue from the sales of EYSUVIS
for the year ended December 31, 2021 compared to the same period in
2020 is due to the commencement of the full commercial launch of
EYSUVIS beginning in January 2021. The decrease of $1.2 million in
net revenue from sales of INVELTYS for the year ended December 31,
2021 compared to the same period in 2020 is primarily the result of
increased product returns.
- Cost of Product Revenues: For the full year
ended December 31, 2021, cost of product revenues was $4.1 million,
compared to $3.2 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 year ended December 31,
2021, compared to the same period in 2020. Partially offsetting
these increases was an additional reserve for excess or obsolete
inventory of $0.5 million recorded during the year ended December
31, 2020, as compared to the year ended December 31, 2021. Non-GAAP
cost of product revenues was $3.9 million for the full year ended
December 31, 2021, compared to $3.0 million for the same period in
2020.
- SG&A Expenses: For the full year ended
December 31, 2021, SG&A expenses were $105.1 million, compared
to $81.1 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
$91.6 million for the full year ended December 31, 2021, compared
to $70.3 million for the same period in 2020.
- R&D Expenses: For the full year ended
December 31, 2021, R&D expenses were $11.5 million, compared to
$18.4 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 year ended December 31, 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 $8.1 million for the full year ended December 31,
2021, compared to $15.0 million for the same period in 2020.
- Acquired IPR&D Expenses: For the full year
ended December 31, 2021, acquired IPR&D were $26.6 million.
Acquired IPR&D for the year ended December 31,
2021 are costs associated with the acquisition of acquired
IPR&D assets from Combangio. There were no acquired IPR&D
expenses for the same period in 2020. Non-GAAP operating loss and
net loss exclude the acquired IPR&D expenses.
- Gain on Fair Value Remeasurement of Deferred Purchase
Consideration: For the full year ended December 31, 2021,
the gain on fair value remeasurement of deferred purchase
consideration, in connection with the Combangio acquisition, was
$5.8 million. There was no gain or loss on fair value remeasurement
of deferred purchase consideration for the same period in 2020.
Non-GAAP operating loss and net loss exclude the gain on fair value
remeasurement of deferred purchase consideration.
- Operating Loss: For the full year ended
December 31, 2021, loss from operations was $130.2 million,
compared to $96.2 million for the same period in 2020. Non-GAAP
operating loss was $92.3 million for the full year ended December
31, 2021, compared to $82.0 million for the same period in
2020.
- Net Loss: For the full year ended December 31,
2021, net loss was $142.6 million, or $2.19 per share, compared to
a net loss of $104.3 million, or $1.99 per share, for the same
period in 2020. Non-GAAP net loss was $99.1 million for the full
year ended December 31, 2021, compared to $89.0 million for the
same period in 2020. The weighted average number of shares used to
calculate net loss per share was 65.2 million for the full year
ended December 31, 2021, and 52.4 million for the full year ended
December 31, 2020.
Conference Call Information:Kala will host a
live conference call and webcast today, March 29, 2022
at 8:00 a.m. ET to review its fourth quarter and full
year 2021 financial results. 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: 7368936. 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, acquired in-process research and
development expense, gain on fair value remeasurement of deferred
purchase consideration, transaction costs related to the
acquisition of Combangio, and the impact of the termination of the
lease for the Company’s former corporate headquarters. Management
believes this non-GAAP information is useful for investors, taken
in conjunction with Kala’s GAAP financial statements, because it
provides greater transparency and period-over-period comparability
with respect to Kala’s operating performance. These measures are
also used by management to assess the performance of the business.
Investors should consider these non-GAAP measures only as a
supplement to, not as a substitute for, or as superior to, measures
of financial performance prepared in accordance with GAAP. In
addition, these non-GAAP financial measures are unlikely to be
comparable with non-GAAP information provided by other companies.
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% and INVELTYS® (loteprednol etabonate ophthalmic
suspension) 1%. The Company also has a pipeline of development
programs including a clinical-stage secretome product candidate,
KPI-012, initially targeting persistent corneal epithelial defects
(PCED) and multiple proprietary new chemical entity (NCE)
preclinical 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. 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, 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 and discussions with regulatory
authorities, 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, expectations
regarding the expansion of Commercial and Medicare Part D payor
coverage, estimates regarding anticipated product revenue, 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, the uncertainties inherent in the initiation and conduct of
preclinical studies and 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) |
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2021 |
|
|
2020 |
Cash, cash equivalents and
short-term investments |
|
|
$ |
92,136 |
|
|
$ |
153,540 |
Total assets |
|
|
|
139,427 |
|
|
|
221,606 |
Working capital (1) |
|
|
|
86,944 |
|
|
|
149,154 |
Long-term debt, net of
discounts |
|
|
|
78,929 |
|
|
|
72,243 |
Other long-term
liabilities |
|
|
|
6,272 |
|
|
|
27,143 |
Total stockholders’
equity |
|
|
|
16,804 |
|
|
|
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.
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Year Ended |
|
December 31, |
|
December 31, |
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
Product revenues, net |
$ |
1,856 |
|
|
$ |
2,238 |
|
|
$ |
11,240 |
|
|
$ |
6,362 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenues |
|
1,418 |
|
|
|
1,359 |
|
|
|
4,097 |
|
|
|
3,173 |
|
Selling, general and administrative |
|
24,027 |
|
|
|
26,466 |
|
|
|
105,061 |
|
|
|
81,068 |
|
Research and development |
|
2,414 |
|
|
|
3,397 |
|
|
|
11,515 |
|
|
|
18,352 |
|
Acquired in-process research and development |
|
26,617 |
|
|
|
— |
|
|
|
26,617 |
|
|
|
— |
|
Gain on fair value remeasurement of deferred purchase
consideration |
|
(5,805 |
) |
|
|
— |
|
|
|
(5,805 |
) |
|
|
— |
|
Total operating expenses |
|
48,671 |
|
|
|
31,222 |
|
|
|
141,485 |
|
|
|
102,593 |
|
Loss from operations |
|
(46,815 |
) |
|
|
(28,984 |
) |
|
|
(130,245 |
) |
|
|
(96,231 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
12 |
|
|
|
42 |
|
|
|
104 |
|
|
|
493 |
|
Interest expense |
|
(2,076 |
) |
|
|
(2,170 |
) |
|
|
(8,380 |
) |
|
|
(8,589 |
) |
Loss on extinguishment of debt |
|
— |
|
|
|
— |
|
|
|
(5,395 |
) |
|
|
— |
|
Gain on lease modification |
|
1,311 |
|
|
|
— |
|
|
|
1,311 |
|
|
|
— |
|
Net loss |
|
(47,568 |
) |
|
|
(31,112 |
) |
|
|
(142,605 |
) |
|
|
(104,327 |
) |
Net loss per share
attributable to common stockholders—basic and diluted |
$ |
(0.68 |
) |
|
$ |
(0.55 |
) |
|
$ |
(2.19 |
) |
|
$ |
(1.99 |
) |
Weighted average shares
outstanding—basic and diluted |
|
69,466,320 |
|
|
|
56,923,421 |
|
|
|
65,202,832 |
|
|
|
52,377,526 |
|
|
Three Months Ended |
|
|
Year Ended |
|
December 31, |
|
|
December 31, |
|
2021 |
|
|
2020 |
|
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss (GAAP) |
$ |
(47,568 |
) |
|
$ |
(31,112 |
) |
|
|
$ |
(142,605 |
) |
|
$ |
(104,327 |
) |
Add-back: stock-based compensation expense |
|
2,748 |
|
|
|
4,063 |
|
|
|
|
16,088 |
|
|
|
13,312 |
|
Add-back: non-cash interest |
|
439 |
|
|
|
277 |
|
|
|
|
1,519 |
|
|
|
1,059 |
|
Add-back: depreciation and amortization |
|
212 |
|
|
|
238 |
|
|
|
|
975 |
|
|
|
912 |
|
Add-back: loss on extinguishment of debt |
|
— |
|
|
|
— |
|
|
|
|
5,395 |
|
|
|
— |
|
Add-back: acquired in-process research and development |
|
26,617 |
|
|
|
— |
|
|
|
|
26,617 |
|
|
|
— |
|
Less: gain on fair value remeasurement of deferred purchase
consideration |
|
(5,805 |
) |
|
|
— |
|
|
|
|
(5,805 |
) |
|
|
— |
|
Add-back: transaction costs related to acquisition of Combangio,
Inc. |
|
1,179 |
|
|
|
— |
|
|
|
|
1,179 |
|
|
|
— |
|
Less: impact of lease modification |
|
(2,467 |
) |
|
|
— |
|
|
|
|
(2,467 |
) |
|
|
— |
|
Non-GAAP net loss |
$ |
(24,645 |
) |
|
$ |
(26,534 |
) |
|
|
$ |
(99,104 |
) |
|
$ |
(89,044 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenues (GAAP) |
$ |
1,418 |
|
|
$ |
1,359 |
|
|
|
$ |
4,097 |
|
|
$ |
3,173 |
|
Less: stock-based compensation expense |
|
60 |
|
|
|
32 |
|
|
|
|
169 |
|
|
|
92 |
|
Less: depreciation and amortization |
|
13 |
|
|
|
13 |
|
|
|
|
52 |
|
|
|
52 |
|
Non-GAAP cost of product revenues |
$ |
1,345 |
|
|
$ |
1,314 |
|
|
|
$ |
3,876 |
|
|
$ |
3,029 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative expenses (GAAP) |
$ |
24,027 |
|
|
$ |
26,466 |
|
|
|
$ |
105,061 |
|
|
$ |
81,068 |
|
Less: stock-based compensation expense |
|
2,364 |
|
|
|
3,207 |
|
|
|
|
12,774 |
|
|
|
10,137 |
|
Less: depreciation and amortization |
|
140 |
|
|
|
171 |
|
|
|
|
693 |
|
|
|
621 |
|
Less: transaction costs related to acquisition of Combangio,
Inc. |
|
1,179 |
|
|
|
— |
|
|
|
|
1,179 |
|
|
|
— |
|
Less: impact of lease modification |
|
(1,156 |
) |
|
|
— |
|
|
|
|
(1,156 |
) |
|
|
— |
|
Non-GAAP selling, general and administrative expenses |
$ |
21,500 |
|
|
$ |
23,088 |
|
|
|
$ |
91,571 |
|
|
$ |
70,310 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses (GAAP) |
$ |
2,414 |
|
|
$ |
3,397 |
|
|
|
$ |
11,515 |
|
|
$ |
18,352 |
|
Less: stock-based compensation expense |
|
324 |
|
|
|
824 |
|
|
|
|
3,145 |
|
|
|
3,083 |
|
Less: depreciation and amortization |
|
59 |
|
|
|
54 |
|
|
|
|
230 |
|
|
|
239 |
|
Non-GAAP research and development expenses |
$ |
2,031 |
|
|
$ |
2,519 |
|
|
|
$ |
8,140 |
|
|
$ |
15,030 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquired in-process research and development expenses (GAAP) |
$ |
26,617 |
|
|
$ |
— |
|
|
|
$ |
26,617 |
|
|
$ |
— |
|
Less: acquired in-process research and development expenses |
|
26,617 |
|
|
|
— |
|
|
|
|
26,617 |
|
|
|
— |
|
Non-GAAP acquired in-process research and development expenses |
$ |
— |
|
|
$ |
— |
|
|
|
$ |
— |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain on fair value remeasurement of deferred purchase consideration
(GAAP) |
$ |
(5,805 |
) |
|
$ |
— |
|
|
|
$ |
(5,805 |
) |
|
$ |
— |
|
Less: gain on fair value remeasurement of deferred purchase
consideration |
|
(5,805 |
) |
|
|
— |
|
|
|
|
(5,805 |
) |
|
|
— |
|
Non-GAAP gain on fair value remeasurement of deferred purchase
consideration |
$ |
— |
|
|
$ |
— |
|
|
|
$ |
— |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating loss (GAAP) |
$ |
(46,815 |
) |
|
$ |
(28,984 |
) |
|
|
$ |
(130,245 |
) |
|
$ |
(96,231 |
) |
Add-back: stock-based compensation expense |
|
2,748 |
|
|
|
4,063 |
|
|
|
|
16,088 |
|
|
|
13,312 |
|
Add-back: depreciation and amortization |
|
212 |
|
|
|
238 |
|
|
|
|
975 |
|
|
|
912 |
|
Add-back: acquired in-process research and development |
|
26,617 |
|
|
|
— |
|
|
|
|
26,617 |
|
|
|
— |
|
Less: gain on fair value remeasurement of deferred purchase
consideration |
|
(5,805 |
) |
|
|
— |
|
|
|
|
(5,805 |
) |
|
|
— |
|
Add back: transaction costs related to acquisition of Combangio,
Inc. |
|
1,179 |
|
|
|
— |
|
|
|
|
1,179 |
|
|
|
— |
|
Less: impact of lease modification |
|
(1,156 |
) |
|
|
— |
|
|
|
|
(1,156 |
) |
|
|
— |
|
Non-GAAP total operating loss |
$ |
(23,020 |
) |
|
$ |
(24,683 |
) |
|
|
$ |
(92,347 |
) |
|
$ |
(82,007 |
) |
KALA BIO (NASDAQ:KALA)
Historical Stock Chart
From Jun 2024 to Jul 2024
KALA BIO (NASDAQ:KALA)
Historical Stock Chart
From Jul 2023 to Jul 2024