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Verastem Oncology Reports Second Quarter 2019 Financial Results and Highlights Recent Company Progress
Company Reports
Cash, Cash Equivalents and Short-Term Investments of
Company to Host Conference Call Today at
“With the third full quarter of the COPIKTRA launch now complete, including the first full quarter of the follicular lymphoma (FL) marketing campaign, net sales are up 81% quarter-over-quarter,” said
Key Second Quarter 2019 and Recent Accomplishments:
Corporate and Financial
- Brian Stuglik Appointed Chief Executive Officer and Other Leadership Changes – In July, Verastem Oncology announced the appointment of
Brian Stuglik as Chief Executive Officer. Mr. Stuglik, who has served as a member of the Company’s Board of Directors sinceSeptember 2017 , succeedsRobert Forrester who stepped down inJune 2019 . Other leadership changes includeDan Paterson , the Company’s Chief Operating Officer, assuming the role of President and Chief Operating Officer andRob Gagnon , the Company’s Chief Financial Officer, appointed to Chief Business and Financial Officer.
- Signed Exclusive License Agreement with
Sanofi for the Development and Commercialization of Duvelisib in Select Eurasian Territories – InJuly 2019 , the Company announced its entry into an exclusive license agreement withSanofi , under which Verastem Oncology granted exclusive rights toSanofi to develop and commercialize products containing COPIKTRA inRussia and CIS,Turkey , theMiddle East andAfrica . Under the terms of the agreement, Verastem Oncology will receive 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 Commercialization of COPIKTRA in
the United States (U.S.) –Verastem Oncology continued the ongoing launch of COPIKTRA, an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, in the U.S. for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies or relapsed or refractory 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. During the second quarter of 2019, the number of prescribing physicians increased by over 50% and the Company has now achieved reimbursement coverage for COPIKTRA with virtually all the targeted insurance plans. COPIKTRA contains a BOXED WARNING and 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.
- Presented COPIKTRA Data at the
American Society of Clinical Oncology (ASCO ) 2019 Annual Meeting – In early June, an abstract was presented atASCO 2019 that highlighted dose modification data from the Phase 3 DUO study evaluating COPIKTRA in patients with relapsed or refractory CLL after at least two prior therapies. This is the same indication for which COPIKTRA received approval from theFDA inSeptember 2018 . These new data demonstrated that dose modifications of COPIKTRA may be used to effectively manage treatment-emergent adverse events, while allowing patients to remain on therapy. Specifically, the data suggest that dosing interruptions of a median of 15 days resulted in similar response rates and progression-free survival to the 16.4 months shown in the COPIKTRA label. The data also showed that when adverse events of special interest (AESIs) occur, they tend to appear in the first few months of treatment, followed by a proportionate decrease in the number of patients experiencing AESIs.
- Presented COPIKTRA Data at the
European Hematology Association (EHA) 2019 Annual Meeting – In June, two posters were presented at EHA 2019. The first poster described results from a post-hoc analysis evaluating the effect of COPIKTRA on lymphocytosis in patients with relapsed or refractory CLL/SLL from the Phase 3 DUO study. In this analysis, treatment with COPIKTRA rapidly increased lymphocytes and resulted in shrinkage of lymph nodes, with 86% of patients achieving a lymph node response. The data were similar in high-risk patients. COPIKTRA also resulted in resolution of lymphocytosis at up to 21 weeks. The other poster was an encore presentation of the COPIKTRA dose modification data fromASCO 2019.
- Presented Supportive Duvelisib Data in Relapsed or Refractory PTCL at the 15th
International Congress on Malignant Lymphoma (ICML) – In June, Dr.Steven Horwitz , MD,Memorial Sloan Kettering Cancer Center , and lead investigator of the Company’s ongoing Phase 2 PRIMO study, gave an oral presentation highlighting supportive data from two Phase 1 clinical studies evaluating duvelisib in patients with relapsed or refractory PTCL. Across both studies, patients treated with duvelisib demonstrated preliminary, but compelling clinical activity, including a positive trend in response rates. The preliminary safety profile of duvelisib in patients with relapsed or refractory PTCL was considered reasonable and consistent with prior studies. The goal of the ongoing Phase 2 PRIMO study is to provide guidance on a duvelisib monotherapy dosing regimen in patients with relapsed or refractory PTCL and to further characterize its efficacy and tolerability in this population.
Other abstracts presented at ICML included an analysis of efficacy and safety of duvelisib compared to ofatumumab from the Phase 3 DUO study in patients with relapsed or refractory CLL/SLL after ≥2 prior therapies, characterization of duvelisib in patients with refractory marginal zone lymphoma from the Phase 2 DYNAMO study, and an overview of preclinical data showing the potential of duvelisib in mantle cell lymphoma.
Second Quarter 2019 Financial Results
Net product revenue for the three months ended
Research and development (R&D) expense for the 2019 Quarter was
Selling, general and administrative expense for the 2019 Quarter was
Net loss for the 2019 Quarter was
For the 2019 Quarter, non-GAAP adjusted net loss was
As of
Financial Guidance for Fiscal 2019
Verastem Oncology is raising its full-year guidance for net product revenue of COPIKTRA. The Company now expects net product revenue of COPIKTRA to be in the range of
Conference Call and Webcast Information
The Verastem Oncology management team will host a conference call and webcast today,
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
About Follicular Lymphoma
Follicular lymphoma (FL) is typically a slow-growing or indolent form of non-Hodgkin lymphoma (
About Peripheral T-Cell Lymphoma
Peripheral T-cell lymphoma (PTCL) is a rare, aggressive type of non-Hodgkin lymphoma (
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
Our first
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
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 for complete Boxed Warning and other important safety information.
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
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
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
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. |
6www.clinicaltrials.gov, NCT03372057 |
Verastem, Inc. Condensed Consolidated Balance Sheets (in thousands) |
|||||||
|
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
||
|
|
2019 |
|
2018 |
|
||
|
|
|
|
|
|
|
|
Cash, cash equivalents and investments |
|
$ |
187,253 |
|
$ |
249,653 |
|
Accounts receivable, net |
|
|
1,389 |
|
|
306 |
|
Inventory |
|
|
294 |
|
|
327 |
|
Prepaid expenses and other current assets |
|
|
3,410 |
|
|
2,973 |
|
Property and equipment, net |
|
|
1,149 |
|
|
1,369 |
|
Intangible assets, net |
|
|
20,793 |
|
|
21,577 |
|
Right-of-use asset, net |
|
|
3,225 |
|
|
— |
|
Other assets |
|
|
1,028 |
|
|
1,031 |
|
Total assets |
|
$ |
218,541 |
|
$ |
277,236 |
|
|
|
|
|
|
|
|
|
Current Liabilities |
|
$ |
31,204 |
|
$ |
37,077 |
|
Long-term debt |
|
|
34,673 |
|
|
19,506 |
|
Convertible senior notes |
|
|
99,163 |
|
|
95,231 |
|
Lease Liability, long-term |
|
|
3,694 |
|
|
— |
|
Other liabilities |
|
|
500 |
|
|
1,123 |
|
Stockholders’ equity |
|
|
49,307 |
|
|
124,299 |
|
Total liabilities and stockholders’ equity |
|
$ |
218,541 |
|
$ |
277,236 |
|
Verastem, Inc. Unaudited Condensed Consolidated Statements of Operations (in thousands, except per share amounts) |
|||||||||||||||||
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|||||||||||||||||
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|
Three months ended June 30, |
|
Six months ended June 30, |
|
||||||||||||
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|
||||||||
Revenue: |
|
|
|
|
|
|
|
|
|
||||||||
Product revenue, net |
|
$ |
3,019 |
|
|
$ |
— |
|
$ |
4,690 |
|
|
$ |
— |
|
||
License and collaboration revenue |
|
|
117 |
|
|
|
10,000 |
|
|
|
117 |
|
|
|
10,000 |
|
|
Total revenue |
|
|
3,136 |
|
|
|
10,000 |
|
|
|
4,807 |
|
|
|
10,000 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of sales - product |
|
|
377 |
|
|
|
— |
|
|
534 |
|
|
|
— |
|
||
Cost of sales - intangible amortization |
|
|
392 |
|
|
|
— |
|
|
785 |
|
|
|
— |
|
||
Research and development |
|
|
11,346 |
|
|
|
12,381 |
|
|
|
21,103 |
|
|
|
23,315 |
|
|
Selling, general and administrative |
|
|
29,298 |
|
|
|
15,813 |
|
|
|
55,331 |
|
|
|
25,640 |
|
|
Total operating expenses |
|
|
41,413 |
|
|
|
28,194 |
|
|
|
77,753 |
|
|
|
48,955 |
|
|
Loss from operations |
|
|
(38,277 |
) |
|
|
(18,194 |
) |
|
|
(72,946 |
) |
|
|
(38,955 |
) |
|
Interest income |
|
|
1,268 |
|
|
|
343 |
|
|
|
2,765 |
|
|
|
534 |
|
|
Interest expense |
|
|
(5,185 |
) |
|
|
(516 |
) |
|
|
(10,115 |
) |
|
|
(996 |
) |
|
Net loss |
|
$ |
(42,194 |
) |
|
$ |
(18,367 |
) |
|
$ |
(80,296 |
) |
|
$ |
(39,417 |
) |
|
Net loss per share—basic and diluted |
|
$ |
(0.57 |
) |
|
$ |
(0.30 |
) |
|
$ |
(1.09 |
) |
|
$ |
(0.70 |
) |
|
Weighted average common shares outstanding used in computing net loss per share—basic and diluted |
|
|
73,877 |
|
|
|
61,256 |
|
|
|
73,865 |
|
|
|
56,074 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Verastem, Inc. Reconciliation of GAAP to Non-GAAP Financial Information (in thousands, except per share amounts) |
||||||||||||||||
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|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Three months ended June 30, |
|
Six months ended June 30, |
|
||||||||||||
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|
||||||||
Net Loss Reconciliation |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net Loss (GAAP basis) |
$ |
(42,194 |
) |
|
$ |
(18,367 |
) |
|
$ |
(80,296 |
) |
|
$ |
(39,417 |
) |
|
Adjust: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Amortization of acquired intangible asset |
|
393 |
|
|
|
— |
|
|
785 |
|
|
|
— |
|
||
Stock-based compensation expense |
|
3,065 |
|
|
|
1,539 |
|
|
|
5,313 |
|
|
|
2,867 |
|
|
Non-cash interest, net |
|
1,207 |
|
|
|
95 |
|
|
|
2,815 |
|
|
|
178 |
|
|
Severance and Other |
|
1,780 |
|
|
|
— |
|
|
1,780 |
|
|
|
— |
|
||
Adjusted Net Loss (non-GAAP basis) |
$ |
(35,749 |
) |
|
$ |
(16,733 |
) |
|
$ |
(69,603 |
) |
|
$ |
(36,372 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Reconciliation of Net Loss Per Share |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net Loss per share – diluted (GAAP Basis) |
|
(0.57 |
) |
|
|
(0.30 |
) |
|
|
(1.09 |
) |
|
|
(0.70 |
) |
|
Adjust per diluted share: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Amortization of acquired intangible asset |
|
0.01 |
|
|
|
— |
|
|
0.01 |
|
|
|
— |
|
||
Stock-based compensation expense |
|
0.04 |
|
|
|
0.03 |
|
|
|
0.07 |
|
|
|
0.05 |
|
|
Non-cash interest, net |
|
0.02 |
|
|
|
0.00 |
|
|
|
0.04 |
|
|
|
0.00 |
|
|
Severance and Other |
|
0.02 |
|
|
|
— |
|
|
0.02 |
|
|
|
— |
|
||
Adjusted Net Loss per share – diluted (non-GAAP Basis) |
$ |
(0.48 |
) |
|
$ |
(0.27 |
) |
|
$ |
(0.94 |
) |
|
$ |
(0.65 |
) |
|
Weighted average common shares outstanding used in computing net loss per share—diluted |
|
73,877 |
|
|
|
61,256 |
|
|
|
73,865 |
|
|
|
56,074 |
|
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20190801005848/en/
Source:
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