BOULDER, Colo., Oct. 30, 2018 /PRNewswire/ -- Array
BioPharma Inc. (Nasdaq: ARRY) today reported results for its first
quarter of fiscal 2019 and provided an update on the progress of
its key commercial products and clinical development programs.
"We have received positive feedback from the melanoma community
and our team continues to execute a robust U.S. launch of BRAFTOVI
+ MEKTOVI for patients with BRAF-mutant melanoma. We were
also delighted BRAFTOVI + MEKTOVI received European Commission
approval in September," said Ron Squarer, Chief Executive Officer.
"Our BEACON CRC Phase 3 trial continues to advance and is supported
by Breakthrough Therapy Designation. We look forward to the interim
analysis of the BEACON CRC trial in the first half of 2019."
MELANOMA
COMMERCIAL
BRAFTOVI + MEKTOVI
U.S. Approval and Launch
BRAFTOVI + MEKTOVI were available
for sale beginning on July 2, 2018,
and patients began receiving the combination therapy that same
week.
Net product sales for the first quarter was $14 million. Array has seen strong demand for
BRAFTOVI + MEKTOVI and continues to receive positive feedback from
healthcare providers, payers and the melanoma community regarding
the combination.
BRAFTOVI + MEKTOVI European Approval
On September 20, 2018, the European Commission
approved BRAFTOVI in combination with MEKTOVI for the treatment of
adult patients with unresectable or metastatic melanoma with a
BRAFV600 mutation, as detected by a validated
test. This approval is applicable to all 28 European Union member
states, as well as Liechtenstein,
Iceland and Norway.
COLUMBUS PHASE 3 TRIAL OVERALL SURVIVAL (OS) RESULTS
PUBLISHED IN THE LANCET ONCOLOGY
Detailed OS results of the
pivotal COLUMBUS trial were published online on September 12, 2018 by The Lancet
Oncology.
- The median OS was 33.6 months for patients treated with
BRAFTOVI + MEKTOVI, compared to 16.9 months for patients treated
with vemurafenib as a monotherapy. The combination reduced the risk
of death compared to treatment with vemurafenib [hazard ratio (HR)
of 0.61, (95% CI 0.47-0.79, p <0.0001)] in the planned analysis
of OS.
- Observed grade 3 or 4 adverse events seen in more than 5% of
patients with BRAFTOVI + MEKTOVI were increased
gamma-glutamyltransferase (9%), increased blood creatine
phosphokinase (7%) and hypertension (6%). Additional safety
information can be found in the manuscript and in the Important
Safety Information and the full Prescribing Information for
BRAFTOVI and MEKTOVI below.
COLORECTAL CANCER (CRC)
BEACON CRC PHASE 3
TRIAL
Breakthrough Therapy Designation
On August
7, 2018, Array announced that the FDA granted Breakthrough Therapy
Designation to BRAFTOVI, in combination with MEKTOVI and cetuximab
for the treatment of patients with
BRAFV600E-mutant metastatic colorectal cancer
(mCRC) as detected by an FDA-approved test, after failure of one to
two prior lines of therapy for metastatic disease.
BRAFV600E-mutant mCRC patients have a mortality
risk more than double that of mCRC patients without the mutation,
and currently there are no therapies specifically approved for this
high unmet need population. [1-6]
Regulatory Update
Following consultation with the FDA
and European Medicines Agency, Array has initiated an amendment to
the BEACON CRC protocol to allow for an interim analysis of trial
endpoints. Should a planned analysis based primarily on confirmed
overall response rate (ORR) and durability of response be
supportive, the Company plans to use it to seek accelerated
approval in the U.S. The interim analysis may also support
regulatory submissions in other regions. The Company anticipates
topline results from this analysis in the first half of 2019. This
timing allows for the subset of patients required for the interim
analysis of ORR to achieve a response and for the durability of
responses to be appropriately evaluated.
The BEACON CRC trial continues to enroll well and Array expects
to complete enrollment of the trial around the end of 2018.
ANCHOR CRC TRIAL
In October 2018, ANCHOR CRC, an
international trial designed to assess the efficacy and safety of
the combination of encorafenib, binimetinib and cetuximab in
patients with BRAFV600E-mutant mCRC in the
first-line setting, was posted to clinicaltrials.gov. This trial
was designed in partnership with top global key opinion leaders and
Array is excited by the potential of this combination therapy to
benefit patients in the first-line setting. The ANCHOR CRC trial is
being conducted in collaboration with Pierre Fabre and Ono Pharmaceutical Co.,Ltd.,
and with support from Merck KGaA, Darmstadt, Germany.
IMMUNO-ONCOLOGY COLLABORATIONS
TRIALS ADVANCING
WITH BRISTOL-MYERS SQUIBB, MERCK
AND PFIZER
Array is developing binimetinib in combination
with PD-1/PD-L1 checkpoint inhibitors and previously
announced separate, strategic collaborations with
Bristol-Myers Squibb, Merck and Pfizer. Each collaboration is
pursuing a different rationally designed clinical approach in
several solid tumor populations including metastatic colorectal
cancer patients with microsatellite stable tumors (BMS and Merck),
and patients with non-small cell lung and pancreatic cancer
(Pfizer). These approaches are characterized by their focus on
earlier lines of therapy and the addition of a third regimen.
FINANCIAL HIGHLIGHTS
First Quarter of Fiscal 2019 Compared to First Quarter of
Fiscal 2018
- Net Product Sales for BRAFTOVI + MEKTOVI for the first
quarter of fiscal 2019 was $14.0
million. The Company has seen strong demand for BRAFTOVI +
MEKTOVI during the quarter and continues to receive positive
feedback from the melanoma community.
- Total Revenue for the first quarter of fiscal 2019
increased by $27.2 million compared
to the same quarter of fiscal 2018. The increase was primarily due
to new product sales and increased milestone revenue from
Pierre Fabre and Loxo Oncology,
which was partially offset by reduced reimbursement revenue from
Novartis as those underlying trials continue to decrease and
certain reimbursement limits are met.
- Cost of Goods Sold related to our product revenues was
$0.2 million which represents 1.4% of
net sales. The Company expects the percentage of net sales in
subsequent quarters to increase as the initial launch inventory was
mostly expensed prior to approval.
- Research and development expense for proprietary
programs increased by $2.3
million, compared to the first quarter of fiscal 2018. The
increase was primarily driven by activities related to the BEACON
CRC trial, which was partially offset by lower activity on the
Novartis transitioned studies.
- Selling, General and Administrative increased by
$12.8 million compared to first
quarter of fiscal 2018, primarily driven by commercialization
activities for the BRAFTOVI and MEKTOVI launch.
- Net loss for the first quarter of fiscal 2019 was
$24.8 million, or ($0.12) per share, compared to $38.0 million, or ($0.22) per share, for the same quarter in fiscal
2018. The decrease in net loss was primarily due to new product
sales and increased milestone revenue from Pierre Fabre and Loxo Oncology, which was
partially offset by reduced reimbursement revenue from
Novartis.
- Cash, cash equivalents and marketable securities as of
September 30, 2018 were $415
million.
CONFERENCE CALL INFORMATION
Array will hold a
conference call on Tuesday, October 30, 2018, at 9:00 a.m. Eastern
Time to discuss these results and provide an update on the progress
of its key commercial products and clinical development programs.
Ron Squarer, Chief Executive Officer, will lead the call.
Date:
|
Tuesday, October 30,
2018
|
Time:
|
9:00 a.m. Eastern
Time
|
Toll-Free:
|
(844)
464-3927
|
Toll:
|
(765)
507-2598
|
Pass
Code:
|
5559328
|
Webcast, including Replay and Conference Call Slides:
https://edge.media-server.com/m6/p/kdv5h8qp
About BRAF-mutant Metastatic
Melanoma
Melanoma develops when unrepaired DNA damage to
skin cells triggers mutations that may lead them to multiply and
form malignant tumors. Metastatic melanoma is the most serious and
life-threatening type of skin cancer and is associated with low
survival rates. [7,8] There are a variety of gene mutations that
can lead to metastatic melanoma. The most common genetic mutation
in metastatic melanoma is BRAF. There are about 200,000 new
cases of melanoma diagnosed worldwide each year, approximately half
of which have BRAF mutations, a key target in the
treatment of metastatic melanoma. [7,9-11]
About BRAFTOVI + MEKTOVI
BRAFTOVI is an oral small
molecule BRAF kinase inhibitor and MEKTOVI is an oral small
molecule MEK inhibitor which target key enzymes in the MAPK
signaling pathway (RAS-RAF-MEK-ERK). Inappropriate activation of
proteins in this pathway has been shown to occur in many cancers
including melanoma, colorectal cancer, non-small cell lung cancer
and others. In the U.S., BRAFTOVI + MEKTOVI are approved for the
treatment of unresectable or metastatic melanoma with
a BRAFV600E or BRAFV600K mutation,
as detected by an FDA-approved test. BRAFTOVI is not indicated
for treatment of patients with wild-type BRAF melanoma. In
Europe, the combination is
approved for adult patients with unresectable or metastatic
melanoma with a BRAFV600 mutation, as
detected by a validated test.
The Swiss Medicines Agency (Swissmedic) and the Australian
Therapeutic Goods Administration (TGA) are currently reviewing the
Marketing Authorization Applications for BRAFTOVI and MEKTOVI
submitted by Pierre Fabre, and
Japan's Pharmaceuticals and
Medical Devices Agency (PMDA) is currently reviewing the
Manufacturing and Marketing Approval applications submitted by Ono
Pharmaceutical Co, Ltd.
Indications and Usage
BRAFTOVI®
(encorafenib) and MEKTOVI® (binimetinib) are kinase
inhibitors indicated for use in combination for the treatment
of patients with unresectable or metastatic melanoma with a
BRAFV600E or
BRAFV600K mutation, as detected by
an FDA-approved test.
Limitations of Use: BRAFTOVI is not indicated for the treatment
of patients with wild-type BRAF melanoma.
BRAFTOVI + MEKTOVI Important Safety
Information
The information below applies to the safety
of the combination of BRAFTOVI and MEKTOVI unless otherwise
noted.
Warnings and Precautions New Primary
Malignancies: New primary malignancies, cutaneous and
non-cutaneous malignancies can occur. In the COLUMBUS trial,
cutaneous squamous cell carcinoma, including keratoacanthoma,
occurred in 2.6% and basal cell carcinoma occurred in 1.6% of
patients. Perform dermatologic evaluations prior to initiating
treatment, every 2 months during treatment, and for up to 6 months
following discontinuation of treatment. Discontinue BRAFTOVI
for RAS mutation-positive non-cutaneous
malignancies.
Tumor Promotion in BRAF Wild-Type
Tumors: Confirm evidence
of BRAFV600E or BRAFV600Kmutation
prior to initiating BRAFTOVI.
Cardiomyopathy: In the COLUMBUS trial,
cardiomyopathy occurred in 7% and Grade 3 left ventricular
dysfunction occurred in 1.6% of patients. Cardiomyopathy resolved
in 87% of patients. Assess left ventricular ejection fraction by
echocardiogram or MUGA scan prior to initiating treatment, 1 month
after initiating treatment, and then every 2 to 3 months during
treatment. The safety has not been established in patients with a
baseline ejection fraction that is either below 50% or below the
institutional lower limit of normal.
Venous Thromboembolism (VTE): In the COLUMBUS trial,
VTE occurred in 6% of patients, including 3.1% of patients who
developed pulmonary embolism.
Hemorrhage: In the COLUMBUS trial, hemorrhage
occurred in 19% of patients and ≥Grade 3 hemorrhage occurred in
3.2% of patients. Fatal intracranial hemorrhage in the setting of
new or progressive brain metastases occurred in 1.6% of
patients.
Ocular Toxicities: In the COLUMBUS trial, serous
retinopathy occurred in 20% of patients; 8% were retinal detachment
and 6% were macular edema. Symptomatic serous retinopathy occurred
in 8% of patients with no cases of blindness. In patients
with BRAF mutation-positive melanoma across
multiple clinical trials, 0.1% of patients experienced retinal vein
occlusion (RVO). Permanently discontinue MEKTOVI in patients with
documented RVO. In COLUMBUS, uveitis, including iritis and
iridocyclitis, was reported in 4% of patients. Assess for visual
symptoms at each visit. Perform ophthalmic evaluation at regular
intervals and for any visual disturbances.
Interstitial Lung Disease (ILD): ILD, including
pneumonitis, occurred in 0.3% of patients
with BRAFmutation-positive melanoma across multiple
clinical trials. Assess new or progressive unexplained pulmonary
symptoms or findings for possible ILD.
Hepatotoxicity: In the COLUMBUS trial, the incidence
of Grade 3 or 4 increases in liver function laboratory tests was 6%
for alanine aminotransferase (ALT) and 2.6% for aspartate
aminotransferase (AST). Monitor liver laboratory tests before and
during treatment and as clinically indicated.
Rhabdomyolysis: In the COLUMBUS trial, elevation of
laboratory values of serum creatine phosphokinase (CPK) occurred in
58% of patients. Rhabdomyolysis was reported in 0.1% of patients
with BRAF mutation-positive melanoma across
multiple clinical trials. Monitor CPK periodically and as
clinically indicated.
QTc Prolongation: In the COLUMBUS trial, an increase
in QTcF to >500 ms was measured in 0.5% (1/192) of patients.
Monitor patients who already have or who are at significant risk of
developing QTc prolongation. Correct hypokalemia and hypomagnesemia
prior to and during BRAFTOVI administration. Withhold, reduce dose,
or permanently discontinue for QTc >500 ms.
Embryo-Fetal Toxicity: BRAFTOVI or MEKTOVI can cause
fetal harm when administered to pregnant women. Nonhormonal
contraceptives should be used during treatment and for at least 30
days after the final dose for patients taking BRAFTOVI +
MEKTOVI.
Adverse Reactions
The most common adverse reactions (≥20%, all Grades, in the
COLUMBUS trial) were: fatigue, nausea, diarrhea, vomiting,
abdominal pain, arthralgia, myopathy, hyperkeratosis, rash,
headache, constipation, visual impairment, serous retinopathy.
In the COLUMBUS trial, the most common laboratory abnormalities
(≥20%, all Grades) included: increased creatinine, increased CPK,
increased gamma glutamyl transferase, anemia, increased ALT,
hyperglycemia, increased AST, and increased alkaline
phosphatase.
Drug interactions
Avoid concomitant use of strong or
moderate CYP3A4 inhibitors or inducers and sensitive CYP3A4
substrates with BRAFTOVI. Modify BRAFTOVI dose if concomitant
use of strong or moderate CYP3A4 inhibitors cannot be avoided.
Please see full Prescribing Information for
BRAFTOVI and full Prescribing Information for
MEKTOVI for additional information [12,13]. You may
report side effects to the FDA at (800) FDA-1088 or
www.fda.gov/medwatch. You may also report side effects to Array at
1-844-Rx-Array (1-844-792-7729).
About COLUMBUS
The COLUMBUS trial (NCT01909453) is a
two-part, international, randomized, open label Phase 3 trial
evaluating the efficacy and safety of BRAFTOVI (encorafenib) in
combination with MEKTOVI (binimetinib) compared to vemurafenib and
encorafenib monotherapy in 921 patients with locally advanced,
unresectable or metastatic melanoma with BRAFV600
mutation. The primary endpoint of the trial was PFS; all secondary
efficacy analyses, including the prospectively planned analysis of
OS, are descriptive in nature. Over 200 sites across North America, Europe, South
America, Africa,
Asia and Australia participated in the trial.
About Colorectal Cancer
Worldwide, colorectal cancer
is the third most common type of cancer in men and the second most
common in women, with approximately 1.4 million new diagnoses in
2012. Globally in 2012, approximately 694,000 deaths were
attributed to colorectal cancer. [14] In the U.S. alone, an
estimated 140,250 patients will be diagnosed with cancer of the
colon or rectum in 2018, and approximately 50,000 are estimated to
die of their disease. [15] In the U.S., BRAF mutations are
estimated to occur in 10% to 15% of patients with colorectal cancer
and represent a poor prognosis for these patients. [5,6,16,17] The
risk of mortality in CRC patients with the
BRAFV600E mutation is more than two times higher
than for those with wild-type BRAF. [18] Several irinotecan
and cetuximab-containing regimens, similar to the BEACON CRC
control arm, have established clinical activity benchmarks in
BRAFV600E-mutant mCRC patients, whose disease has
progressed after one or two prior lines of therapy. These
benchmarks include ORR of 4% to 8% ,mPFS of 1.8 to 2.5 months and
median OS of 4 to 6 months. [1-6,19]
About BEACON CRC
BEACON CRC is a randomized,
open-label, global trial evaluating the efficacy and safety of
BRAFTOVI, MEKTOVI and cetuximab in patients with
BRAFV600E-mutant mCRC whose disease has
progressed after one or two prior regimens. BEACON CRC is the first
and only Phase 3 trial designed to test a BRAF/MEK combo targeted
therapy in BRAFV600E-mutant mCRC. Thirty patients
were treated in the safety lead-in and received the triplet
combination (BRAFTOVI 300 mg daily, MEKTOVI 45 mg twice daily and
cetuximab per label). Of the 30 patients, 29 had a
BRAFV600E mutation. MSI-H, resulting from
defective DNA mismatch repair, was detected in only 1 patient. As
previously announced, the triplet combination demonstrated good
tolerability, supporting initiation of the randomized portion of
the trial.
The randomized portion of the BEACON CRC trial is designed to
assess the efficacy of BRAFTOVI in combination with cetuximab with
or without MEKTOVI compared to cetuximab and irinotecan-based
therapy. Approximately 615 patients are expected to be randomized
1:1:1 to receive triplet combination, doublet combination (BRAFTOVI
and cetuximab) or the control arm (irinotecan-based therapy and
cetuximab). The study has been amended to include an interim
analysis of endpoints including ORR. The primary overall
survival endpoint is a comparison of the triplet combination to the
control arm. Secondary endpoints address efficacy of the doublet
combination compared to the control arm, and the triplet
combination compared to the doublet therapy. Other secondary
endpoints include PFS, duration of response, safety and
tolerability. Health related quality of life data will also be
assessed. The trial is being conducted at over 200 investigational
sites in North America,
South America, Europe and the Asia
Pacific region. The BEACON CRC trial is being conducted with
support from Ono Pharmaceutical Co., Pierre
Fabre and Merck KGaA, Darmstadt, Germany (support is for sites outside of
North America).
About Array BioPharma
Array BioPharma Inc. is a
fully-integrated, biopharmaceutical company focused on the
discovery, development and commercialization of transformative and
well-tolerated targeted small molecule drugs to treat patients
afflicted with cancer and other high-burden diseases. Array markets
in the United States
BRAFTOVI® (encorafenib) capsules in combination with
MEKTOVI® (binimetinib) tablets for the treatment of
patients with unresectable or metastatic melanoma with a
BRAFV600E or BRAFV600K
mutation. Array's lead clinical programs, encorafenib and
binimetinib, are being investigated in over 30 clinical trials
across a number of solid tumor indications, including a Phase 3
trial in BRAF-mutant colorectal cancer. Array's pipeline
includes several additional programs being advanced by Array or
current license-holders, including the following programs currently
in registration trials: selumetinib (partnered with AstraZeneca),
larotrectinib and LOXO-292 (partnered with Loxo Oncology),
ipatasertib (partnered with Genentech), tucatinib (partnered with
Seattle Genetics) and ARRY-797. Ganovo® (danoprevir,
partnered with Roche) was recently approved in China for the treatment of viral hepatitis C.
For more information on Array, please visit www.arraybiopharma.com
or follow @arraybiopharma on Twitter and LinkedIn.
References
[1] Kopetz et al., ASCO
2017.
[2] De Roock et al., Lancet Oncol.
2010.
[3] Ulivi et al., J Transl Med. 2012.
[4] Peeters et al., ASCO 2014.
[5] Saridaki et
al., PLoS One. 2013.
[6] Loupakis et al., Br J
Cancer. 2009.
[7] Melanoma Skin Cancer. American Cancer Society. Available
at: https://www.cancer.org/cancer/melanoma-skin-cancer.html.
Accessed January 2018.
[8] A Snapshot of Melanoma. National Cancer Institute.
Available
at: https://seer.cancer.gov/statfacts/html/melan.html.
Accessed January 2018.
[9] Globocan 2012: Estimated Cancer Incidence, Mortality and
Prevalence Worldwide in
2012. http://globocan.iarc.fr/Pages/fact_sheets_population.aspx.
Accessed January 2018.
[10] Klein O, et al. Eur J Cancer,
2013.
[11] American Cancer Society. What Causes Melanoma Skin
Cancer?
2016. https://www.cancer.org/cancer/melanoma-skin-cancer/causes-risks-prevention/what-causes.html.
Accessed April 11, 2018.
[12] BRAFTOVI® (encorafenib) Prescribing
Information. Array BioPharma Inc., June
2018
[13] MEKTOVI® (binimetinib) Prescribing Information.
Array BioPharma Inc., June 2018
[14] Global Cancer Facts & Figures 3rd Edition. American Cancer
Society. Available at:
https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/global-cancer-facts-and-figures/global-cancer-facts-and-figures-3rd-edition.pdf.
Accessed January 2018.
[15] Cancer Facts & Figures 2018. American Cancer
Society. Available at:
https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2018/cancer-facts-and-figures-2018.pdf.
Accessed January 2018.
[16] Sorbye, et al. PLoS One. 2015.
[17] Vecchione, et al. Cell. 2016.
[18] Safaee, et al. PLoS One. 2012.
[19] Seymour et al., Lancet Oncol. 2013 (supplementary
appendix).
Forward-Looking Statement
This press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, including, among others,
statements about the future development plans of encorafenib and
binimetinib; expectations that events will occur that will create
greater value for Array; and the potential for the results of
current and future clinical trials to support regulatory approval
or the marketing success of encorafenib and binimetinib. Because
these statements reflect our current expectations concerning future
events and involve significant risks and uncertainties, our actual
results could differ materially from those anticipated in these
forward-looking statements as a result of many factors. These
factors include, but are not limited to, the potential that the
FDA, EMA or other regulatory agencies determine results from
clinical trials are not sufficient to support registration or
marketing approval of encorafenib and binimetinib; our ability to
effectively and timely conduct clinical trials in light of
increasing costs and difficulties in locating appropriate trial
sites and in enrolling patients who meet the criteria for certain
clinical trials; risks associated with our dependence on
third-party service providers to successfully conduct clinical
trials and to manufacture drug substance and product within and
outside the U.S.; our ability to grow and successfully develop
commercialization capabilities; our ability to achieve and maintain
profitability and maintain sufficient cash resources; and our
ability to attract and retain experienced scientists and
management. Additional information concerning these and other risk
factors can be found in our most recent annual report filed on Form
10-K, in our quarterly reports filed on Form 10-Q, and in other
reports filed by Array with the Securities and Exchange Commission.
We are providing this information as of October 30, 2018. We undertake no duty to update
any forward-looking statements to reflect the occurrence of events
or circumstances after the date of such statements or of
anticipated or unanticipated events that alter any assumptions
underlying such statements.
BRAFTOVI® and MEKTOVI® are registered
trademarks of Array BioPharma Inc. in the United States and various other
countries.
Array BioPharma
Inc.
|
Consolidated
Statements of Operations
|
(Unaudited)
|
(in thousands,
except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
|
|
|
|
|
|
September
30,
|
|
|
|
|
|
|
|
2018
|
|
2017
|
|
Revenue
|
|
|
|
|
|
|
|
Product sales,
net
|
|
|
$
13,993
|
|
$
-
|
|
|
Collaboration and
license revenue
|
|
|
31,028
|
|
11,554
|
|
|
Reimbursement
revenue
|
|
|
11,889
|
|
18,192
|
|
|
|
Total
revenue
|
|
|
56,910
|
|
29,746
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
|
195
|
|
-
|
|
|
Research and
development
|
|
|
55,550
|
|
53,204
|
|
|
Selling, general and
administrative
|
|
|
24,890
|
|
12,048
|
|
|
|
Total operating
expenses
|
|
|
80,635
|
|
65,252
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
(23,725)
|
|
(35,506)
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense)
|
|
|
|
|
|
|
|
Interest
income
|
|
|
1,524
|
|
525
|
|
|
Interest
expense
|
|
|
(2,580)
|
|
(3,213)
|
|
|
Other
|
|
|
(30)
|
|
200
|
|
|
|
Total other income
(expense), net
|
|
|
(1,086)
|
|
(2,488)
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
|
|
$
(24,811)
|
|
$
(37,994)
|
|
Net loss per share
- basic and diluted
|
|
|
$
(0.12)
|
|
$
(0.22)
|
|
Weighted average
shares outstanding - basic and diluted
|
|
|
212,193
|
|
174,772
|
|
|
|
|
|
|
|
|
|
|
|
Summary
Consolidated Balance Sheet Data
|
(Unaudited)
|
(in
thousands)
|
|
|
|
|
|
|
September 30,
2018
|
|
June 30,
2018
|
|
|
|
|
Cash, cash
equivalents and marketable securities
|
|
$
415,391
|
|
$
413,406
|
|
|
|
|
Working
capital
|
|
|
$
391,444
|
|
$
355,612
|
|
|
|
|
Total
assets
|
|
|
$
484,219
|
|
$
460,364
|
|
|
|
|
Long-term debt, net
and notes payable at fair value
|
$
131,093
|
|
$
111,775
|
|
|
|
|
Total stockholders'
equity
|
|
|
$
219,068
|
|
$
219,743
|
|
|
|
|
|
|
|
|
|
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CONTACT:
Array BioPharma
Andrea N. Flynn, Ph.D.
Senior Director, Investor Relations & Corporate
Communications
(303) 381-6600
ir@arraybiopharma.com
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SOURCE Array BioPharma Inc.