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 first quarter ended March
31, 2022 and provided a corporate update.
“Since our founding, we have been committed to developing
innovative medicines that can better treat diseases of the front
and back of the eye and we have advanced two products to market,
which address significant unmet needs in dry eye disease and
post-ocular surgery,” said Mark Iwicki, Chief Executive Officer and
Chairman of Kala. “Securing broad market access so prescriptions
can be filled at reasonable costs is of paramount importance in the
success of any commercial launch. I’m very pleased that in recent
months, we have made meaningful progress toward our goal of
increasing payer coverage for EYSUVIS. We recently expanded EYSUVIS
coverage to more than 90% of commercial lives and 30% of Medicare
lives, which we believe will enable more prescriptions to be filled
and support long-term revenue growth. As we have been working to
expand market access, we have used patient assistance programs to
help ensure prescriptions are filled and have seen increased usage
in the first quarter of 2022, representing an increased demand for
EYSUVIS but also negatively impacting our net revenues. With the
recent expansion in payor coverage, we expect our patient
assistance programs to have less of an impact on average selling
price, and thus net revenue, in the future.”
Kala continues to progress the development of KPI-012, and
believes it has broad potential to change the standard of care in
persistent corneal epithelial defect (PCED), as well as other rare
and severe ocular diseases. The Company expects to initiate a Phase
2/3 clinical trial of KPI-012 for PCED later this year, subject to
regulatory clearance, and plans to provide updates on its
indication expansion strategy in the months ahead.
First Quarter and Recent Business
Highlights:
Commercial Portfolio:
EYSUVIS® (loteprednol etabonate ophthalmic suspension)
0.25%: Data from Symphony Health indicate that 26,518
EYSUVIS prescriptions were filled in the first quarter of 2022,
representing quarter-over-quarter growth of 18%. EYSUVIS
prescription growth has continued in the second quarter of 2022. As
of the week ended May 6, 2022, 103,514 prescriptions of EYSUVIS,
including over 17,955 refill prescriptions, written by more than
8,200 unique prescribers, have been filled since the product
launched in January 2021.
In May 2022, Kala announced that the largest Pharmacy Benefit
Manager in the United States added EYSUVIS as a covered brand on
its commercial formularies, effective May 2, 2022. In addition,
effective June 1, 2022, Humana, one of the largest Medicare health
plans in the United States, will include EYSUVIS as a “preferred
brand” on its Medicare formularies. With these additions, Kala has
secured coverage for 155.3 million commercial lives, representing
approximately 92% of all commercially insured lives, and 14.1
million Medicare lives, representing approximately 30% of all
Medicare-insured lives. Kala expects this expanded payor coverage
to substantially reduce reliance on co-pay assistance programs and,
as a result, significantly improve the Company’s gross-to-net
adjustments. Kala continues to engage in contract discussions with
other health plans and expects to further expand formulary coverage
in 2022.
INVELTYS® (loteprednol etabonate ophthalmic suspension)
1%: 34,691 INVELTYS prescriptions were reported by
Symphony Health in the first quarter of 2022, compared to 36,695
prescriptions reported in the fourth quarter of 2021. INVELTYS
prescriptions were impacted by the reduction in ocular surgeries
due to the pandemic but the amount of ocular surgeries has since
returned to pre-pandemic levels. Despite this trend, the market for
the treatment of post-operative inflammation and pain following
ocular surgery has become more generic causing the branded market
to decline. Kala believes that INVELTYS prescriptions and revenues
will grow 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 PCED, the first
indication that Kala is pursuing for KPI-012, and other severe
ocular diseases driven by impaired corneal healing.
At the Association for Research in Vision and Ophthalmology
(ARVO) Annual Meeting in May 2022, Kala presented data from a Phase
1b clinical trial of KPI-012. The single arm trial enrolled
patients with PCED of various etiologies, who were treated with
KPI-012 twice daily for up to four weeks and followed for up to 12
weeks. Of the eight patients who were evaluable for efficacy, six
achieved complete healing after four weeks of treatment, including
four who were healed by the end of one week of treatment and one
who was healed by the end of the second week of treatment. All six
healed patients remained healed through the end of the follow-up
period. In addition, an improvement in PCED lesion size was
observed in both patients who did not experience full wound
healing. KPI-012 was generally well-tolerated in the trial.
Kala plans to submit an investigational new drug application to
the U.S. Food and Drug Administration for KPI-012 and, subject to
regulatory clearance, initiate a Phase 2/3 clinical trial in
patients suffering from PCED in the fourth quarter of 2022. Kala
believes this trial could serve as the first of two required
pivotal trials needed for securing a potential PCED indication in
the U.S. and potentially in other countries.
In addition, Kala believes KPI-012 represents a platform
technology due to its multifactorial mechanism of action and is
evaluating KPI-012 for potential expansion to other ocular
indications. Based on existing pre-clinical and clinical data, Kala
believes that KPI-012 has the potential to treat multiple corneal
diseases characterized by severe ocular surface damage driven by
impaired healing. Additionally, mesenchymal stem cell secretomes
are known to contain constituents with therapeutic potential for
diseases of the back of the eye. The Company is currently
conducting an in-depth analysis to identify potential additional
front and back of the eye indications for future development.
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 and gain
or loss on fair value remeasurement of deferred purchase and
contingent consideration. 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 March 31, 2022, Kala had
cash, cash equivalents and short-term investments of $70.2 million,
compared to $92.1 million of cash and cash equivalents as of
December 31, 2021. This decrease reflects cash used in operations.
Based on its current plans, Kala anticipates that its cash
resources as of March 31, 2022, together with anticipated revenue
from EYSUVIS and INVELTYS, will enable it to fund its operations
into the second quarter of 2023.
First Quarter 2022 Financial Results:
- Net Product Revenues: For the quarter ended
March 31, 2022, Kala reported net product revenues of $1.4 million,
consisting of $1.0 million of net revenue from EYSUVIS sales and
$0.4 million of net revenue from INVELTYS sales, compared to net
product revenues of $3.3 million for the same period in 2021,
consisting of $1.6 million of net revenues from EYSUVIS sales and
$1.6 million of net reviews from INVELTYS sales.
- Cost of Product Revenues: For the quarter
ended March 31, 2022, cost of product revenues was $0.8 million,
consistent with the same period in 2021. Non-GAAP cost of product
revenues was $0.7 million for the quarter ended March 31, 2022,
consistent with the same period in 2021.
- SG&A Expenses: For the quarter ended March
31, 2022, selling, general and administrative (SG&A) expenses
were $27.0 million, compared to $27.7 million for the same period
in 2021. The decrease was primarily due to decreases in stock-based
compensation and facility related costs. Non-GAAP SG&A expenses
were $24.7 million for the quarter ended March 31, 2022, compared
to $23.8 million for the same period in 2021.
- R&D Expenses: For the quarter ended March
31, 2022, research and development (R&D) expenses were $4.5
million, compared to $3.1 million for the same period in 2021. The
increase was primarily due to increased spending on pipeline
programs, including development costs for KPI-012, in the quarter
ended March 31, 2022, as compared to the same period in 2021.
Non-GAAP R&D expenses were $3.9 million for the quarter ended
March 31, 2022, compared to $2.1 million for the same period in
2021.
- Loss on Fair Value Remeasurement of Deferred Purchase
Consideration: For the quarter ended March 31, 2022, the
loss on fair value remeasurement of deferred purchase
consideration, in connection with the Combangio acquisition, was
$1.1 million. There was no gain or loss on fair value remeasurement
of deferred purchase consideration for the same period in 2021.
Non-GAAP operating loss and non-GAAP net loss exclude the loss on
fair value remeasurement of deferred purchase consideration.
- Gain on Fair Value Remeasurement of Contingent
Consideration: For the quarter ended March 31, 2022, the
gain on fair value remeasurement of contingent consideration, in
connection with the Combangio acquisition, was $1.0 million. There
was no gain or loss on fair value remeasurement of contingent
consideration for the same period in 2021. Non-GAAP operating loss
and non-GAAP net loss exclude the gain on fair value remeasurement
of contingent consideration.
- Operating Loss: For the quarter
ended March 31, 2022, loss from operations was $30.9
million, compared to $28.3 million for the same period in
2021. Non-GAAP operating loss was $27.9 million for the
quarter ended March 31, 2022, compared to $23.4
million for the same period in 2021.
- Net Loss: For the quarter ended March 31,
2022, net loss was $32.9 million, or $0.45 per share, compared to a
net loss of $30.4 million, or $0.49 per share, for the same period
in 2021. Non-GAAP net loss was $29.5 million for the quarter ended
March 31, 2022, compared to $25.2 million for the same period in
2021. The weighted average number of shares used to calculate net
loss per share was 73.6 million for the quarter ended March 31,
2022, and 61.7 million for the quarter ended March 31, 2021.
Conference Call Information:Kala will host a
live conference call and webcast today, May 16, 2022 at 8:00 a.m.
ET to review its first quarter 2022 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: 6384677. 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 and gain
or loss on fair value remeasurement of deferred purchase and
contingent consideration. 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, Inc.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; 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.
Investor Contacts:
Jill Steierjill.steier@kalarx.com
781-996-5252
Hannah Deresiewiczhannah.deresiewicz@sternir.com
212-362-1200
Financial Tables:
Kala Pharmaceuticals, Inc. |
Balance Sheet Data |
(in thousands) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2022 |
|
|
|
2021 |
Cash, cash equivalents and short-term investments |
|
|
$ |
70,162 |
|
|
|
$ |
92,136 |
Total assets |
|
|
|
111,574 |
|
|
|
|
139,427 |
Working capital (1) |
|
|
|
65,497 |
|
|
|
|
86,944 |
Long-term debt, net of
discounts |
|
|
|
79,361 |
|
|
|
|
78,929 |
Other long-term
liabilities |
|
|
|
4,739 |
|
|
|
|
6,272 |
Total stockholders’ (deficit)
equity |
|
|
|
(5,284 |
) |
|
|
|
16,804 |
(1) The Company defines working capital as current assets less
current liabilities. See the Company's consolidated financial
statements for further information regarding its current assets and
current liabilities.
Kala Pharmaceuticals,
Inc.Consolidated Statement of
Operations(In thousands, except share and per
share data)(Unaudited)
|
Three Months Ended |
|
March 31, |
|
2022 |
|
2021 |
|
|
|
|
|
|
Product revenues, net |
$ |
1,372 |
|
|
$ |
3,266 |
|
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
Cost of product revenues |
|
775 |
|
|
|
755 |
|
Selling, general and administrative |
|
26,982 |
|
|
|
27,699 |
|
Research and development |
|
4,466 |
|
|
|
3,126 |
|
Loss on fair value remeasurement of deferred purchase
consideration |
|
1,051 |
|
|
|
— |
|
Gain on fair value remeasurement of contingent consideration |
|
(988 |
) |
|
|
— |
|
Total operating expenses |
|
32,286 |
|
|
|
31,580 |
|
Loss from operations |
|
(30,914 |
) |
|
|
(28,314 |
) |
Other income (expense): |
|
|
|
|
|
Interest income |
|
8 |
|
|
|
43 |
|
Interest expense |
|
(2,035 |
) |
|
|
(2,141 |
) |
Net loss |
|
(32,941 |
) |
|
|
(30,412 |
) |
Net loss per share
attributable to common stockholders—basic and diluted |
$ |
(0.45 |
) |
|
$ |
(0.49 |
) |
Weighted average shares
outstanding—basic and diluted |
|
73,640,830 |
|
|
|
61,655,867 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Kala Pharmaceuticals,
Inc.Reconciliation of GAAP to Non-GAAP Financial
Measures(In
thousands)(Unaudited)
|
Three Months Ended |
|
March 31, |
|
2022 |
|
2021 |
|
|
|
|
|
|
Net loss (GAAP) |
$ |
(32,941 |
) |
|
$ |
(30,412 |
) |
Add-back: stock-based compensation expense |
|
2,805 |
|
|
|
4,702 |
|
Add-back: non-cash interest |
|
432 |
|
|
|
278 |
|
Add-back: depreciation and amortization |
|
157 |
|
|
|
248 |
|
Add-back: loss on fair value remeasurement of deferred purchase
consideration |
|
1,051 |
|
|
|
— |
|
Less: gain on fair value remeasurement of contingent
consideration |
|
(988 |
) |
|
|
— |
|
Non-GAAP net loss |
$ |
(29,484 |
) |
|
$ |
(25,184 |
) |
|
|
|
|
|
|
Cost of product revenues (GAAP) |
$ |
775 |
|
|
$ |
755 |
|
Less: stock-based compensation expense |
|
48 |
|
|
|
34 |
|
Less: depreciation and amortization |
|
13 |
|
|
|
13 |
|
Non-GAAP cost of product revenues |
$ |
714 |
|
|
$ |
708 |
|
|
|
|
|
|
|
Selling, general and administrative expenses (GAAP) |
$ |
26,982 |
|
|
$ |
27,699 |
|
Less: stock-based compensation expense |
|
2,232 |
|
|
|
3,702 |
|
Less: depreciation and amortization |
|
89 |
|
|
|
181 |
|
Non-GAAP selling, general and administrative expenses |
$ |
24,661 |
|
|
$ |
23,816 |
|
|
|
|
|
|
|
Research and development expenses (GAAP) |
$ |
4,466 |
|
|
$ |
3,126 |
|
Less: stock-based compensation expense |
|
525 |
|
|
|
966 |
|
Less: depreciation and amortization |
|
55 |
|
|
|
54 |
|
Non-GAAP research and development expenses |
$ |
3,886 |
|
|
$ |
2,106 |
|
|
|
|
|
|
|
Loss on fair value remeasurement of deferred purchase consideration
(GAAP) |
$ |
1,051 |
|
|
$ |
— |
|
Less: loss on fair value remeasurement of deferred purchase
consideration |
|
1,051 |
|
|
|
— |
|
Non-GAAP loss on fair value remeasurement of deferred purchase
consideration |
$ |
— |
|
|
$ |
— |
|
|
|
|
|
|
|
Gain on fair value remeasurement of contingent consideration
(GAAP) |
$ |
(988 |
) |
|
$ |
— |
|
Less: gain on fair value remeasurement of contingent
consideration |
|
(988 |
) |
|
|
— |
|
Non-GAAP gain on fair value remeasurement of contingent
consideration |
$ |
— |
|
|
$ |
— |
|
|
|
|
|
|
|
Total operating loss (GAAP) |
$ |
(30,914 |
) |
|
$ |
(28,314 |
) |
Add-back: stock-based compensation expense |
|
2,805 |
|
|
|
4,702 |
|
Add-back: depreciation and amortization |
|
157 |
|
|
|
248 |
|
Add-back: loss on fair value remeasurement of deferred purchase
consideration |
|
1,051 |
|
|
|
— |
|
Less: gain on fair value remeasurement of contingent
consideration |
|
(988 |
) |
|
|
— |
|
Non-GAAP total operating loss |
$ |
(27,889 |
) |
|
$ |
(23,364 |
) |
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