Company Reports $1.7 Million in Net Product
Revenues from COPIKTRA™; Issues Product Revenue Guidance for
2019
Cash, Cash Equivalents and Short-Term
Investments of $211.7 Million as of March 31, 2019
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 March 31, 2019.
“We are now into the second full quarter of the COPIKTRA launch
and sales were up approximately 38% compared to the prior quarter,”
said Robert Forrester, President and Chief Executive Officer of
Verastem Oncology. “We have also made substantial progress securing
broader reimbursement for our product, with over 92% of targeted
health plans now listing and providing reimbursement for COPIKTRA.
We continue to receive positive feedback from physicians using
COPIKTRA for the treatment of patients with relapsed or refractory
chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)
after at least two prior therapies or follicular lymphoma (FL)
after at least two prior systemic therapies.”
“The commercial team has been diligently working to enhance
physician and advocacy group awareness of COPIKTRA, and to overcome
certain historical misperceptions concerning the PI3K class. We
believe the groundwork we have laid over the past several months
will have an increasingly positive impact through 2019 and into
next year. In parallel, we continue to advance duvelisib in
additional lines of therapy, both as a monotherapy and in
combination, as well as in additional indications like peripheral
T-cell lymphoma (PTCL) for which preliminary data are expected by
the end of this year,” concluded Mr. Forrester.
Key First Quarter 2019 and Recent Accomplishments:
COPIKTRA (duvelisib)
- Launched COPIKTRA in FL – In
mid-March 2019, upon completion of the required 120-day waiting
period following receipt of accelerated approval from the FDA, the
Company launched its physician education and marketing campaign for
COPIKTRA for the treatment of patients with FL after at least two
prior systemic therapies. Accelerated approval in FL was based on
overall response rate and continued approval may be contingent upon
confirmatory trials, the first of which is expected to start in
2019.
- Presented COPIKTRA Data at the
23rd Annual International Congress on Hematologic
Malignancies (ICHM) – The Company presented four COPIKTRA
abstracts at ICHM 2019, including an abstract highlighting Phase 3
DUO data in patients with relapsed or refractory CLL/SLL who have
progressed following two prior lines of the therapy. This is the
same indication for which COPIKTRA received approval from the FDA
in September 2018. In this analysis, COPIKTRA demonstrated
progression-free survival (PFS) of 16.4 months and an ORR of 78%,
with a manageable safety profile. The remaining three abstracts
featured data from a long-term (>2 years) efficacy and safety
analysis, the Phase 3 DUO crossover extension study, and prognostic
and immune-related factors associated with response to duvelisib
from the Phase 2 DYNAMO™ study in indolent non-Hodgkin’s lymphoma
(iNHL). Collectively, the data presented at ICHM 2019 continue to
support the use of COPIKTRA in its approved indications of relapsed
or refractory CLL/SLL after at least two prior therapies and FL
after at least two prior systemic therapies. PDF copies of all of
the ICHM 2019 poster presentations are available here.
- Phase 2 DYNAMO Study Results
Published in the Journal of Clinical Oncology – In February
2019, results of the Phase 2 DYNAMO™ study, which evaluated
COPIKTRA in patients with indolent non-Hodgkin lymphoma (iNHL) who
were refractory to both rituximab and chemotherapy or
radioimmunotherapy, was published online in the peer-reviewed
Journal of Clinical Oncology. The full manuscript, titled “DYNAMO:
A Phase II Study of Duvelisib (IPI-145) in Patients with Refractory
Indolent Non-Hodgkin Lymphoma,” (Flinn, et al. DOI:
10.1200/JCO.18.00915) can be accessed at www.ascopubs.org.
- Continued Commercialization of
COPIKTRA in the United States – Verastem Oncology launched
COPIKTRA, an oral inhibitor of phosphoinositide 3-kinase (PI3K),
and the first approved dual inhibitor of PI3K-delta and PI3K-gamma,
in the United States following FDA approval for the treatment of
adult patients with relapsed or refractory CLL/SLL after at least
two prior therapies. COPIKTRA also received accelerated approval
for the treatment of adult patients with relapsed or refractory FL
after at least two prior systemic therapies.COPIKTRA contains a
BOXED WARNING for fatal and/or serious toxicities including
infections, diarrhea or colitis, cutaneous reactions, and
pneumonitis. Verastem Oncology has implemented a Risk Evaluation
and Mitigation Strategy to provide appropriate dosing and safety
information to better support physicians in managing their patients
on COPIKTRA.Additionally, use of COPIKTRA is associated with other
adverse reactions which may also require dose reduction, treatment
delay or discontinuation of COPIKTRA.Please see
www.COPIKTRAHCP.com/prescribinginformation for full Prescribing
Information including BOXED WARNING and Select Important Safety
Information provided below.
Corporate and Financial
- Chief Commercial Officer Joseph
Lobacki to Step Down in 2019 – Joseph Lobacki, Chief Commercial
Officer of Verastem Oncology will be stepping down from the Company
in 2019 to pursue other professional opportunities, including Board
of Director roles. Mr. Lobacki intends to continue in his role
until the Company identifies and appoints a successor. During this
transition, Brian Stuglik, RPh, a member of the Company’s Board of
Directors and the former Chief Marketing Officer of Lilly Oncology,
will provide strategic oversight and advisory support for the
commercial organization.
- Amended Hercules Loan Facility –
In April 2019, the Company announced an amendment to its existing
Loan and Security Agreement with Hercules Capital, Inc., changing
key terms of the agreement, including a lower overall interest rate
and an extended principal repayment timeline. The amendment also
increases the borrowing limit from $50 million to $75 million in
financing.
First Quarter 2019 Financial Results
Net product revenue for the 2019 Quarter was $1.7 million, which
reflects the second full quarter of recorded sales for COPIKTRA.
The Company did not have any product revenue for the 2018 Quarter
as the FDA approved COPIKTRA on September 24, 2018.
Research and development (R&D) expense for the 2019 Quarter
was $9.8 million, compared to $10.9 million for the 2018 Quarter.
The decrease of $1.1 million, or 11%, was primarily related to a
decrease in consulting fees as a result of activities to file a New
Drug Application for COPIKTRA in the 2018 Quarter and lower R&D
costs associated with the development of COPIKTRA as a result of
site closures in the Company’s Phase 3 DUO and Phase 2 DYNAMO
studies throughout 2018 and 2019 as patients continue to complete
treatment. All of these lower costs were partially offset by an
increase in costs related to the Phase 2 PRIMO study for the
treatment of patients with relapsed or refractory PTCL.
Selling, general and administrative expense for the 2019 Quarter
was $26.0 million, compared to $9.8 million for the 2018 Quarter.
The increase of $16.2 million, or 165%, was primarily due to higher
personnel and related costs, as well as promotional and consulting
costs in support of the launch of COPIKTRA.
Net loss for the three months ended March 31, 2019 (2019
Quarter) was $38.1 million, or $0.52 per share (basic and diluted),
as compared to $21.1 million, or $0.41 per share (basic and
diluted), for the three months ended March 31, 2018 (2018 Quarter).
In addition, net loss includes non-cash stock-based compensation
expense of $2.2 million and $1.3 million for the 2019 and 2018
Quarters, respectively.
As of March 31, 2019, Verastem Oncology had cash, cash
equivalents and short-term investments of $211.7 million.
Financial Outlook
For 2019, the Company expects net product revenue from sales of
COPIKTRA to be in the range of $10-12 million, 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, Thursday, May 9, 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 7199457.
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 a rare, 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™ (duvelisib) – Select Important Safety
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% 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% of COPIKTRA-treated patients. Monitor for
the development of severe diarrhea or colitis. Withhold
COPIKTRA.
- Fatal and/or serious cutaneous
reactions occurred in 5% of COPIKTRA-treated patients. Withhold
COPIKTRA.
- Fatal and/or serious pneumonitis
occurred in 5% of COPIKTRA-treated patients. Monitor for pulmonary
symptoms and interstitial infiltrates. Withhold COPIKTRA.
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 SUSPECTED ADVERSE REACTIONS, contact Verastem, Inc.
(Verastem) at 877-7RXVSTM or 1-877-779-8786, or U.S. Food and Drug
Administration (FDA) at 1-800-FDA-1088 or www.fda.gov/medwatch.
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.
See full Prescribing Information, including Boxed Warning,
at www.COPIKTRA.com
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. 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)
March 31, December 31,
2019 2018 Cash, cash equivalents and
investments $ 211,659 $ 249,653 Accounts receivable, net 558 306
Inventory 306 327 Prepaid expenses and other current assets 4,073
2,973 Property and equipment, net 1,256 1,369 Intangible assets,
net 21,185 21,577 Other assets 4,328 1,031
Total
assets $ 243,365 $ 277,236
Current Liabilities $ 28,624 $ 37,077 Long-term debt 24,814 19,506
Convertible senior notes 97,159 95,231 Other liabilities 4,308
1,123 Stockholders’ equity 88,460 124,299
Total
liabilities and stockholders’ equity $ 243,365
$ 277,236
Verastem, Inc.
Unaudited Condensed Consolidated
Statements of Operations
(in thousands, except per share
amounts)
Three months ended March 31, 2019
2018 Revenue: Product revenue, net $ 1,671 $ — Total revenue
1,671 — Operating expenses: Costs of revenues,
excluding amortization of acquired intangible assets 158 — Research
and development 9,758 10,934 Selling, general and administrative
26,033 9,827 Amortization of acquired intangible assets 392
— Total operating expenses 36,341 20,761 Loss
from operations (34,670) (20,761) Interest income
1,497 191 Interest expense (4,929) (480) Net loss
$ (38,102) $ (21,050) Net loss per
share—basic and diluted
$ (0.52) $
(0.41)
Weighted average common shares outstanding
used in computingnet loss per share—basic and diluted
73,854 50,835
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190509005837/en/
Verastem Oncology:John DoyleVice President, Investor Relations
& Finance+1 781-469-1546jdoyle@verastem.com
Investors:Joseph RayneArgot Partners+1
617-340-6075joseph@argotpartners.com
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