Company Reports $9 Million in Total Revenue,
including $4.0 Million in Net Product Revenue from COPIKTRA®;
Reaffirms FY2019 Revenue Guidance
Cash, Cash Equivalents and Short-Term
Investments of $160.2 Million as of September 30, 2019
Company to Streamline Organization and Reduce
Operating Expenses by $25 Million in 2020
Company to Host Conference Call Today at 4:30
PM ET
Verastem, Inc. (Nasdaq: VSTM), operating as Verastem Oncology
(or “the Company”), focused on developing and commercializing
medicines seeking to improve the survival and quality of life of
cancer patients, today reported financial results for the three
months ended September 30, 2019, and provided an overview of recent
accomplishments and clinical development progress for duvelisib
(COPIKTRA®).
“In the third quarter, we achieved $9.0 million in revenue,
including $4.0 million in net product revenue from COPIKTRA, a 33%
increase over the prior quarter, and we remain on track to achieve
the revenue that we have guided for this year. We continue to make
progress with COPIKTRA sales as the intent to prescribe and new
prescriber base grows week over week due to solid progress across
our commercial efforts, including physician education and
contracting. We also believe in the long-term potential for our
current COPIKTRA indications,” said Brian Stuglik, Chief Executive
Officer of Verastem Oncology. “We are deeply committed to our
long-term strategy to achieve sustainable growth and progress our
mission on behalf of patients. In order to achieve these ambitious
goals and provide us with greater financial flexibility going
forward, we are streamlining our organization and reducing
operating expenses, which will result in approximately $25 million
in annualized cost savings next year.”
Key Third Quarter 2019 and Recent Accomplishments
Corporate and Financial
- Implementing a Corporate Restructuring as Part of the
Long-Term “6-2-5” Strategy – Verastem Oncology continues to
deliver on its “6-2-5” strategic plan in which we aim to narrow the
gap between revenue and commercial spend by year end 2019, achieve
cash flow break-even for both the commercial and clinical COPIKTRA
program by mid-2021, and the indications for COPIKTRA are broadened
with at least one additional marketed product, along with a
pipeline of assets in development by mid-2024. In order to support
this strategy, the company will be reducing overall operating
expenses, including the elimination of approximately 40 current
positions across all functions. The workforce reduction is designed
to streamline operations, speed execution, and reflect the focused,
account-based approach in the field. The Company expects minimal
impact on top-line revenue results with these changes. The overall
reduction in operating expenses is expected to result in
approximately $25 million in annualized cost savings in 2020.
Verastem Oncology estimates that it will incur approximately $1.0
million in pre-tax charges for severance and other costs related to
the workforce reduction, the majority of which will be incurred in
2019.
- Signed Exclusive License Agreement with Sanofi for the
Development and Commercialization of Duvelisib in Select Eurasian
Territories – In July 2019, the Company announced its entry
into an exclusive license agreement with Sanofi, under which
Verastem Oncology granted exclusive rights to Sanofi to develop and
commercialize products containing COPIKTRA in Russia and CIS,
Turkey, the Middle East and Africa. Under the terms of the
agreement, Verastem Oncology received an upfront payment of $5
million (USD) and is eligible to receive aggregate payments of up
to $42 million if certain development and sales milestones are
successfully achieved, plus double-digit percentage royalties based
on future net sales of COPIKTRA in the licensed territories. In
exchange, Sanofi received exclusive rights to develop and
commercialize COPIKTRA and hold the marketing authorization and
product license for COPIKTRA in the licensed territories.
Additionally, Sanofi will have the right to collaborate with
Verastem Oncology on certain global development and clinical trial
activities.
COPIKTRA (duvelisib)
- Ongoing Commercial Rollout of COPIKTRA in the United States
(U.S.) – COPIKTRA, the Company’s oral inhibitor of
phosphoinositide 3-kinase (PI3K), and the first FDA-approved dual
inhibitor of PI3K-delta and PI3K-gamma continues to gain momentum
in the U.S. generating revenues of $4.0 million during the third
quarter of 2019, a 33% increase over the prior quarter. As of the
end of the third quarter 2019, the number of prescribing physicians
had increased by over 30%, compared to the end of the prior
quarter.
- Yakult Doses First Patient in Japanese Bridging Study
Evaluating COPIKTRA in Relapsed or Refractory CLL/SLL – In
early October, Verastem Oncology’s partner Yakult Honsha Co., Ltd.
(Yakult) dosed the first patient in a Phase 1b Japanese bridging
study evaluating COPIKTRA in patients with relapsed or refractory
CLL/SLL following at least one prior therapy. Yakult’s multicenter,
open-label Phase 1b study is expected to enroll approximately 10
patients and the primary endpoint of the study is objective
response rate. Secondary endpoints of the study include overall
survival, progression free survival and safety. This Phase 1b study
is expected to serve as a bridging study based on the efficacy and
safety observed in Verastem Oncology’s Phase 3 DUO study. The
results of the Phase 1b bridging study are expected to form the
basis of a regulatory submission for COPIKTRA for the treatment of
relapsed or refractory CLL/SLL in Japan.
- Duvelisib Receives Orphan Drug Designation from FDA for the
Treatment of T-Cell Lymphoma – In early October, duvelisib
(COPIKTRA) received orphan drug designation from the FDA for use in
the treatment of T-Cell lymphoma. The designation was created to
encourage the development of drugs that may provide significant
benefit to patients suffering from rare diseases. Duvelisib is not
currently approved for the treatment of T-cell lymphoma. The
Company recently completed the dose optimization/dose selection
phase of the PRIMO study in patients with relapsed or refractory
peripheral T-cell lymphoma (PTCL) and has submitted the data for
presentation at the American Society of Hematology 2019 Annual
Meeting in December. The registration-directed portion of the PRIMO
study is currently on going and is being conducted in the U.S.,
Europe and Japan.
- Presented New Preclinical Duvelisib Data at the 5th
International Conference on New Concepts in Lymphoid
Malignancies– In early October, an abstract was presented at
the meeting that showed superior anti-cancer activity of the dual
PI3K-delta/gamma inhibitor duvelisib compared to the PI3K-delta
inhibitor idelalisib in preclinical models of mantle cell lymphoma
(MCL). Verastem Oncology’s goal is to expand into additional
lymphoid malignancy indications and these data provide additional
support for the future study of duvelisib through clinical trials
in patients with MCL. Duvelisib is not approved for use in
MCL.
- Presented Seven COPIKTRA Abstracts at Two Prestigious
Medical Meetings – Throughout September, Verastem Oncology
continued to have a strong scientific presence for COPIKTRA at
important medical congresses. The Company presented a total of
seven COPIKTRA abstracts at two prestigious medical oncology
meetings; the 18th Annual International Workshop on Chronic
Lymphocytic Leukemia (iwCLL) and the Society of Hematologic
Oncology 2019 Annual Meeting. Collectively, the presented abstracts
highlighted a wide range of duvelisib clinical data, including data
from the Phase 3 DUO study in patients with relapsed or refractory
CLL/SLL, dose modification data from the Phase 3 DUO study, data
from a post-hoc analysis evaluating the effect of COPIKTRA on
lymphocytosis, including in patients with high-risk factors, and
data from the Phase 2 DYNAMO in patients with refractory marginal
zone lymphoma. These presented data continue to support the ongoing
commercialization of COPIKTRA.
Third Quarter 2019 Financial Results
Total revenue for the three months ended September 30, 2019
(2019 Quarter) was $9.0 million. Net product revenue for the 2019
Quarter was $4.0 million, compared to $0.5 million for the three
months ended September 30, 2018 (2018 Quarter), following the FDA’s
approval of COPIKTRA on September 24, 2018. License and
collaboration revenue for the 2019 Quarter was $5.0 million,
compared to $15.0 million for the 2018 Quarter. The 2018 Quarter
included license revenue of $15.0 million related to an upfront
payment pursuant to a license and collaboration agreement executed
between Verastem Oncology and CSPC Pharmaceutical Group Limited in
September 2018. The 2019 Quarter includes a $5.0 million upfront
payment received pursuant to a license and collaboration agreement
executed between Verastem Oncology and Sanofi in July 2019.
Total operating expenses for the 2019 Quarter were $35.1
million, compared to $41.4 million for the second quarter of 2019
and compared to $37.1 million for the 2018 Quarter.
Research and development (R&D) expense for the 2019 Quarter
was $12.2 million, compared to $11.6 million for the 2018 Quarter.
The increase of $0.6 million, or 5.2%, was primarily related to an
increase of $0.4 million in contract research organizations (CRO)
costs and an increase of $0.3 million related to personnel costs,
including non-cash stock-based compensation, partially offset by a
decrease of $0.1 million in consulting costs. The $0.4 million
increase in CRO costs is primarily related to an increase of $1.5
million for the Company’s planned DUETTO and TEMPO studies,
partially offset by a decrease of $1.0 million resulting from site
closures for the Phase 3 DUO and Phase 2 DYNAMO studies as patients
continue to complete treatment.
Selling, general and administrative expense for the 2019 Quarter
was $22.2 million, compared to $25.4 million for the 2018 Quarter.
The decrease of $3.2 million, or 12.6%, was primarily due to a
decrease of $2.3 million in consulting and professional fees,
primarily related to the support of commercial launch preparation
activities in the 2018 Quarter and a decrease of $0.9 million in
personnel related costs, including non-cash stock-based
compensation.
Net loss for the 2019 Quarter was $30.1 million, or $0.41 per
share (basic and diluted), compared to $21.7 million, or $0.29 per
share (basic and diluted), for the 2018 Quarter.
For the 2019 Quarter, non-GAAP adjusted net loss was $26.2
million, or $0.35 per share, compared to non-GAAP adjusted net loss
of $19.4 million, or $0.26 per share, for the 2018 Quarter. Please
refer to the GAAP to Non-GAAP Reconciliation attached to this press
release.
As of September 30, 2019, Verastem Oncology had cash, cash
equivalents and short-term investments of $160.2 million.
Financial Guidance for Fiscal 2019
Verastem Oncology is reiterating its full-year 2019 guidance and
expects net product revenue for COPIKTRA to be in the range of
$12-14 million. This guidance is based on product revenue to date,
current run rates and near-term expectations.
Conference Call and Webcast Information
The Verastem Oncology management team will host a conference
call and webcast today, Tuesday, October 29, 2019, at 4:30 PM (ET).
The call can be accessed by dialing (877) 341-5660 (U.S. and
Canada) or (315) 625-3226 (international), five minutes prior to
the start of the call and providing the passcode 5785818.
The live, listen-only webcast of the conference call can be
accessed by visiting the investors section of the Company's website
at www.verastem.com. A replay of the webcast will be archived on
the Company's website for 90 days following the call.
About Chronic Lymphocytic Leukemia/Small Lymphocytic
Lymphoma
Chronic lymphocytic leukemia (CLL) and small lymphocytic
lymphoma (SLL) are cancers that affect lymphocytes and are
essentially the same disease, with the only difference being the
location where the cancer primarily occurs. When most of the cancer
cells are located in the bloodstream and the bone marrow, the
disease is referred to as CLL, although the lymph nodes and spleen
are often involved. When the cancer cells are located mostly in the
lymph nodes, the disease is called SLL. The symptoms of CLL/SLL
include a tender, swollen abdomen and feeling full even after
eating only a small amount. Other symptoms can include fatigue,
shortness of breath, anemia, bruising easily, night sweats, weight
loss, and frequent infections. However, many patients with CLL/SLL
will live for years without symptoms. In 2018, there were
approximately 200,000 patients in the United States affected by
CLL/SLL with nearly 20,000 new diagnoses. While there are therapies
currently available, real-world data reveals that a significant
number of patients either relapse following treatment, become
refractory to current agents, or are unable to tolerate treatment,
representing a significant medical need. The potential of
additional oral agents, particularly as a monotherapy that can be
used in the general community physician’s armamentarium, may hold
significant value in the treatment of patients with CLL/SLL.
About Follicular Lymphoma
Follicular lymphoma (FL) is typically a slow-growing or indolent
form of non-Hodgkin lymphoma (NHL) that arises from B-lymphocytes,
making it a B-cell lymphoma. In 2018, this lymphoma subtype
accounted for 20 to 30 percent of all NHL cases, with more than
140,000 people in the United States with FL and more than 13,000
newly diagnosed patients. Common symptoms of FL include enlargement
of the lymph nodes in the neck, underarms, abdomen, or groin, as
well as fatigue, shortness of breath, night sweats, and weight
loss. Often, patients with FL have no obvious symptoms of the
disease at diagnosis. Follicular lymphoma is usually not considered
to be curable, but more of a chronic disease, with patients living
for many years with this form of lymphoma. The potential of
additional oral agents, particularly as a monotherapy that can be
used in the general community physician’s armamentarium, may hold
significant value in the treatment of patients with FL.
About Peripheral T-Cell Lymphoma
Peripheral T-cell lymphoma (PTCL) is an aggressive type of
non-Hodgkin lymphoma (NHL) that develops in mature white blood
cells called “T cells” and “natural killer (NK) cells”1 which
circulate with the lymphatic system.2 PTCL accounts for between
10-15% of all non-Hodgkin lymphomas (NHLs) and generally affects
people aged 60 years and older.1 Although there are many different
subtypes of peripheral T-cell lymphoma, they often present in a
similar way, with widespread, enlarged, painless lymph nodes in the
neck, armpit or groin.2 There is currently no established standard
of care for patients with relapsed or refractory disease.1
About COPIKTRA™ (duvelisib)
COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase
(PI3K), and the first approved dual inhibitor of PI3K-delta and
PI3K-gamma, two enzymes known to help support the growth and
survival of malignant B-cells. PI3K signaling may lead to the
proliferation of malignant B-cells and is thought to play a role in
the formation and maintenance of the supportive tumor
microenvironment.3,4,5 COPIKTRA is indicated for the treatment of
adult patients with relapsed or refractory chronic lymphocytic
leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two
prior therapies and relapsed or refractory follicular lymphoma (FL)
after at least two prior systemic therapies. COPIKTRA is also being
developed by Verastem Oncology for the treatment of peripheral
T-cell lymphoma (PTCL), for which it has received Fast Track
status, and is being investigated in combination with other agents
through investigator-sponsored studies.6 For more information on
COPIKTRA, please visit www.COPIKTRA.com. Information about
duvelisib clinical trials can be found on
www.clinicaltrials.gov.
About Verastem Oncology
Verastem Oncology (Nasdaq: VSTM) is a commercial
biopharmaceutical company committed to the development and
commercialization of medicines to improve the lives of patients
diagnosed with cancer. We are driven by the strength, tenacity and
courage of those battling cancer – single-minded in our resolve to
deliver new therapies that not only keep cancer at bay but improve
the lives of patients diagnosed with cancer. Because for us, it’s
personal.
Our first FDA approved product is now available for the
treatment of patients with certain types of indolent non-Hodgkin’s
lymphoma (iNHL). Our pipeline comprises product candidates that
seek to treat cancer by modulating the local tumor
microenvironment. For more information, please visit
www.verastem.com.
COPIKTRA includes a Boxed Warning for fatal and serious
toxicities including infections, diarrhea or colitis, cutaneous
reactions and pneumonitis. See full Prescribing Information for
complete Boxed Warning and other important safety information.
SELECT IMPORTANT SAFETY INFORMATION
This does not include all information needed to use COPIKTRA™
(duvelisib) safely and effectively. See full Prescribing
Information.
WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA
OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS
See full Prescribing Information for
complete boxed warning
- Fatal and/or serious infections occurred in 31% (4% fatal) of
COPIKTRA-treated patients. Monitor for signs and symptoms of
infection. Withhold COPIKTRA if infection is suspected.
- Fatal and/or serious diarrhea or colitis occurred in 18%
(<1% fatal) of COPIKTRA-treated patients. Monitor for the
development of severe diarrhea or colitis. Withhold COPIKTRA.
- Fatal and/or serious cutaneous reactions occurred in 5% (<1%
fatal) of COPIKTRA-treated patients. Withhold COPIKTRA.
- Fatal and/or serious pneumonitis occurred in 5% (<1% fatal)
of COPIKTRA-treated patients. Monitor for pulmonary symptoms and
interstitial infiltrates. Withhold COPIKTRA.
INDICATIONS AND USAGE
COPIKTRA is a kinase inhibitor indicated for the treatment of
adult patients with:
- Relapsed or refractory chronic lymphocytic leukemia (CLL) or
small lymphocytic lymphoma (SLL) after at least two prior
therapies.
- Relapsed or refractory follicular lymphoma (FL) after at least
two prior systemic therapies. Accelerated approval based on overall
response rate and continued approval may be contingent upon
confirmatory trials
WARNINGS AND PRECAUTIONS
- Hepatotoxicity: Monitor hepatic function.
- Neutropenia: Monitor blood counts.
- Embryo-Fetal toxicity: COPIKTRA can cause fetal harm. Advise
patients of potential risk to a fetus and to use effective
contraception.
ADVERSE REACTIONS
The most common adverse reactions (≥20%) are diarrhea or
colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper
respiratory infection, pneumonia, musculoskeletal pain, and
anemia.
To report Adverse Reactions, contact FDA at 1-800-FDA-1088
(1-800-332-1088) or www.fda.gov/medwatch and Verastem Oncology at
1-877-7RXVSTM (1-877-779-8786).
DRUG INTERACTIONS
- CYP3A inducers: Avoid co-administration with strong CYP3A
inducers.
- CYP3A inhibitors: Monitor for COPIKTRA toxicities when
co-administered with strong or moderate CYP3A inhibitors. Reduce
COPIKTRA dose to 15 mg twice daily when co-administered with strong
CYP3A4 inhibitors.
- CYP3A substrates: Monitor for signs of toxicities when
co-administering COPIKTRA with sensitive CYP3A substrates.
USE IN SPECIFIC POPULATIONS
Lactation: Advise women not to breastfeed.
Use of Non-GAAP Financial Measures
To supplement Verastem Oncology’s condensed consolidated
financial statements, which are prepared and presented in
accordance with generally accepted accounting principles in the
United States (GAAP), the Company uses the following non-GAAP
financial measures in this press release: non-GAAP adjusted net
loss and non-GAAP net loss per share. These non-GAAP financial
measures exclude certain amounts or expenses from the corresponding
financial measures determined in accordance with GAAP. Management
believes this non-GAAP information is useful for investors, taken
in conjunction with the Company’s GAAP financial statements,
because it provides greater transparency and period-over-period
comparability with respect to the Company’s operating performance
and can enhance investors’ ability to identify operating trends in
the Company’s business. Management uses these measures, among other
factors, to assess and analyze operational results and trends and
to make financial and operational decisions. Non-GAAP information
is not prepared under a comprehensive set of accounting rules and
should only be used to supplement an understanding of the Company’s
operating results as reported under GAAP, not in isolation or as a
substitute for, or superior to, financial information prepared and
presented in accordance with GAAP. In addition, these non-GAAP
financial measures are unlikely to be comparable with non-GAAP
information provided by other companies. The determination of the
amounts that are excluded from non-GAAP financial measures is a
matter of management judgment and depends upon, among other
factors, the nature of the underlying expense or income amounts.
Reconciliations between these non-GAAP financial measures and the
most comparable GAAP financial measures for the three and six
months ended June 30, 2019 and 2018 are included in the tables
accompanying this press release after the unaudited condensed
consolidated financial statements.
Forward looking statements notice
This press release and the commentary in the conference call to
be held today each include forward-looking statements about
Verastem Oncology’s strategy, future plans and prospects, including
statements regarding the development and activity of Verastem
Oncology’s lead product COPIKTRA, and Verastem Oncology’s PI3K
program generally, its commercialization of COPIKTRA, the potential
commercial success of COPIKTRA, including financial guidance and
patient population estimates, the anticipated adoption of COPIKTRA
by patients and physicians, the structure of its planned and
pending clinical trials and the timeline and indications for
clinical development, regulatory submissions and commercialization
activities. The words "anticipate," "believe," "estimate,"
"expect," "intend," "may," "plan," "predict," "project," "target,"
"potential," "will," "would," "could," "should," "continue," and
similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. Each forward-looking statement is subject
to risks and uncertainties that could cause actual results to
differ materially from those expressed or implied in such
statement.
Applicable risks and uncertainties include the risks and
uncertainties, among other things, regarding: the commercial
success of COPIKTRA in the United States; physician and patient
adoption of COPIKTRA, including those related to the safety and
efficacy of COPIKTRA; the uncertainties inherent in research and
development of COPIKTRA, such as negative or unexpected results of
clinical trials; whether and when any applications for COPIKTRA may
be filed with regulatory authorities in any other jurisdictions;
whether and when regulatory authorities in any other jurisdictions
may approve any such other applications that may be filed for
COPIKTRA, which will depend on the assessment by such regulatory
authorities of the benefit-risk profile suggested by the totality
of the efficacy and safety information submitted and, if approved,
whether COPIKTRA will be commercially successful in such
jurisdictions; our ability to obtain, maintain and enforce patent
and other intellectual property protection for COPIKTRA and our
other product candidates; the scope, timing, and outcome of any
legal proceedings; decisions by regulatory authorities regarding
labeling and other matters that could affect the availability or
commercial potential of COPIKTRA; the fact that regulatory
authorities in the U.S. or other jurisdictions, if approved, could
withdraw approval; whether preclinical testing of our product
candidates and preliminary or interim data from clinical trials
will be predictive of the results or success of ongoing or later
clinical trials; that the timing, scope and rate of reimbursement
for our product candidates is uncertain; that third-party payors
(including government agencies) may not reimburse for COPIKTRA;
that there may be competitive developments affecting our product
candidates; that data may not be available when expected; that
enrollment of clinical trials may take longer than expected; that
COPIKTRA or our other product candidates will cause unexpected
safety events, experience manufacturing or supply interruptions or
failures, or result in unmanageable safety profiles as compared to
their levels of efficacy; that COPIKTRA will be ineffective at
treating patients with lymphoid malignancies; that we will be
unable to successfully initiate or complete the clinical
development and eventual commercialization of our product
candidates; that the development and commercialization of our
product candidates will take longer or cost more than planned; that
we may not have sufficient cash to fund our contemplated
operations; that we, CSPC Pharmaceutical Group, Yakult Honsha Co.,
Ltd., Sanofi or Infinity Pharmaceuticals, Inc. will fail to fully
perform under the duvelisib license agreements; that we may be
unable to make additional draws under our debt facility or obtain
adequate financing in the future through product licensing,
co-promotional arrangements, public or private equity, debt
financing or otherwise; that we will not pursue or submit
regulatory filings for our product candidates, including for
duvelisib in patients with chronic lymphocytic leukemia/small
lymphocytic lymphoma (CLL/SLL) or indolent non-Hodgkin lymphoma
(iNHL) in other jurisdictions; and that our product candidates will
not receive regulatory approval, become commercially successful
products, or result in new treatment options being offered to
patients.
Other risks and uncertainties include those identified under the
heading "Risk Factors" in the Company’s Annual Report on Form 10-K
for the year ended December 31, 2018 as filed with the SEC on March
12, 2019 and in any subsequent filings with the SEC. The
forward-looking statements contained in this press release reflect
Verastem Oncology’s views as of the date hereof, and the Company
does not assume and specifically disclaims any obligation to update
any forward-looking statements whether as a result of new
information, future events or otherwise, except as required by
law.
References
1 The Leukemia & Lymphoma Society. Peripheral T-Cell
Lymphoma Facts. July 2014.
2 Leukemia Foundation.
http://www.leukaemia.org.au/blood-cancers/lymphomas/non-hodgkin-lymphoma-nhl/peripheral-t-cell-lymphoma
3 Winkler D.G., Faia K.L., DiNitto J.P. et al. PI3K-delta and
PI3K-gamma inhibition by IPI-145 abrogates immune responses and
suppresses activity in autoimmune and inflammatory disease models.
Chem Biol 2013; 20:1-11.
4 Reif K et al. Cutting Edge: Differential Roles for
Phosphoinositide 3 kinases, p110-gamma and p110-delta, in
lymphocyte chemotaxis and homing. J Immunol 2004:173:2236-2240.
5 Schmid M et al. Receptor Tyrosine Kinases and TLR/IL1Rs
Unexpectedly activate myeloid cell PI3K, a single convergent point
promoting tumor inflammation and progression. Cancer Cell 2011;
19:715-727.
6 www.clinicaltrials.gov, NCT03372057
Verastem, Inc.
Condensed Consolidated Balance
Sheets
(in thousands)
(unaudited)
September 30,
December 31,
2019
2018
Cash, cash equivalents and investments
$
160,228
$
249,653
Accounts receivable, net
2,203
306
Inventory
478
327
Prepaid expenses and other current
assets
4,049
2,973
Property and equipment, net
1,041
1,369
Intangible assets, net
20,400
21,577
Right-of-use asset, net
3,146
—
Other assets
1,055
1,031
Total assets
$
192,600
$
277,236
Current Liabilities
$
30,510
$
37,077
Long-term debt
34,882
19,506
Convertible senior notes
101,249
95,231
Lease Liability, long-term
3,572
—
Other liabilities
870
1,123
Stockholders’ equity
21,517
124,299
Total liabilities and stockholders’
equity
$
192,600
$
277,236
Verastem, Inc.
Unaudited Condensed
Consolidated Statements of Operations
(in thousands, except per share
amounts)
(unaudited)
Three months ended September
30,
Nine months ended September
30,
2019
2018
2019
2018
Revenue:
Product revenue, net
$
4,032
$
508
$
8,722
$
508
License and collaboration revenue
5,000
15,000
5,118
25,000
Total revenue
9,032
15,508
13,840
25,508
Operating expenses:
Cost of sales - product
371
49
906
49
Cost of sales - intangible
amortization
392
31
1,177
31
Research and development
12,219
11,571
33,322
34,886
Selling, general and administrative
22,153
25,426
77,484
51,066
Total operating expenses
35,135
37,077
112,889
86,032
Loss from operations
(26,103)
(21,569)
(99,049)
(60,524)
Interest income
1,005
763
3,770
1,297
Interest expense
(5,041)
(862)
(15,156)
(1,858)
Net loss
$
(30,139)
$
(21,668)
$
(110,435)
$
(61,085)
Net loss per share—basic and diluted
$
(0.41)
$
(0.29)
$
(1.49)
$
(0.99)
Weighted average common shares outstanding
used in computing net loss per share—basic and diluted
74,228
73,644
73,988
61,995
Verastem, Inc.
Reconciliation of GAAP to
Non-GAAP Financial Information
(in thousands, except per share
amounts)
(unaudited)
Three months ended September
30,
Nine months ended September
30,
2019
2018
2019
2018
Net Loss Reconciliation
Net Loss (GAAP basis)
$
(30,139)
$
(21,668)
$
(110,435)
$
(61,085)
Adjust:
Amortization of acquired intangible
asset
392
31
1,177
31
Stock-based compensation expense
1,915
2,040
7,228
4,908
Non-cash interest, net
1,611
156
4,426
335
Severance and Other
40
—
1,820
—
Adjusted Net Loss (non-GAAP
basis)
$
(26,181)
$
(19,441)
$
(95,784)
$
(55,811)
Reconciliation of Net Loss Per
Share
Net Loss per share – diluted
(GAAP Basis)
(0.41)
(0.29)
(1.49)
(0.99)
Adjust per diluted share
Amortization of acquired intangible
asset
0.01
0.0
0.02
0.00
Stock-based compensation expense
0.03
0.03
0.10
0.08
Non-cash interest, net
0.02
0.00
0.06
0.01
Severance and Other
0.00
—
0.02
—
Adjusted Net Loss per share –
diluted
(non-GAAP Basis)
$
(0.35)
$
(0.26)
$
(1.29)
$
(0.90)
Weighted average common shares outstanding
used in computing net loss per share— diluted
74,228
73,644
73,988
61,995
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191029006089/en/
Investors: John Doyle Vice President, Investor Relations &
Finance +1 781-469-1546 jdoyle@verastem.com
Media: Lisa Buffington Corporate Communications +1 781-292-4205
lbuffington@verastem.com
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