Press Release
<< Back
Verastem Oncology Reports Third Quarter 2019 Financial Results and Recent Company Progress
Company Reports
Cash, Cash Equivalents and Short-Term Investments of
Company to
Company to Host Conference Call Today at
“In the third quarter, we achieved
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 – 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 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 firstFDA -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 inJapan . -
Duvelisib Receives Orphan Drug Designation from
FDA for the Treatment of T-Cell Lymphoma – In early October, duvelisib (COPIKTRA) received orphan drug designation from theFDA 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 theAmerican 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 andJapan .
-
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 theSociety 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
Total operating expenses for the 2019 Quarter were
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 reiterating its full-year 2019 guidance and expects net product revenue for 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 an 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 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
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
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
2
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
|
|
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
|
|
392 |
|
31 |
|
1,177 |
|
31 |
Research and development |
|
12,219 |
|
11,571 |
|
33,322 |
|
34,886 |
Selling, general and
|
|
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
|
$ |
(0.41) |
$ |
(0.29) |
$ |
(1.49) |
$ |
(0.99) |
Weighted average common
|
|
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
|
|
392 |
|
31 |
|
1,177 |
|
31 |
Stock-based compensation
|
|
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
|
$ |
(26,181) |
$ |
(19,441) |
$ |
(95,784) |
$ |
(55,811) |
|
|
|
|
|
|
|
|
|
Reconciliation of Net Loss Per
|
|
|
|
|
|
|
|
|
Net Loss per share – diluted (GAAP Basis) |
|
(0.41) |
|
(0.29) |
|
(1.49) |
|
(0.99) |
Adjust per diluted share |
|
|
|
|
|
|
|
|
Amortization of acquired
|
|
0.01 |
|
0.0 |
|
0.02 |
|
0.00 |
Stock-based compensation
|
|
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 –
(non-GAAP Basis) |
$ |
(0.35) |
$ |
(0.26) |
$ |
(1.29) |
$ |
(0.90) |
Weighted average common
|
|
74,228 |
|
73,644 |
|
73,988 |
|
61,995 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20191029006089/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