BOULDER, Colo., May 7, 2019 /PRNewswire/ -- Array BioPharma
Inc. (Nasdaq: ARRY) today reported results for its third quarter of
fiscal 2019 and provided an update on the progress of its key
commercial products and clinical development programs.
"U.S. demand for BRAFTOVI + MEKTOVI for patients with
BRAF-mutant metastatic melanoma continues to be strong with
over $35 million in net product sales
during the third commercial quarter," said Ron Squarer, Chief
Executive Officer. "We are also pleased the combination of
BRAFTOVI, MEKTOVI and cetuximab or panitumumab was recommended by
NCCN guidelines as a treatment option for patients with advanced
BRAFV600E-mutant colorectal cancer. We look
forward to reporting topline results from the BEACON CRC interim
analysis this quarter."
MELANOMA
U.S. Sales
BRAFTOVI + MEKTOVI net
product sales for the third quarter were $35.1 million.
Japanese Launch
On February 26,
2019, BRAFTOVI + MEKTOVI was launched in Japan and is indicated for unresectable
melanoma with a BRAF mutation.
COLORECTAL CANCER (CRC)
BEACON CRC PHASE 3
TRIAL
National Comprehensive Cancer Network (NCCN)
Recommendation
On March 18,
2019, Array announced that the National Comprehensive Cancer
Network (NCCN) updated their Clinical Practice Guidelines in
Oncology for Colon and Rectal Cancer to include BRAFTOVI in
combination with MEKTOVI and ERBITUX® (cetuximab)
or panitumumab as a Category 2A treatment for patients with
BRAFV600E-mutant metastatic colorectal cancer
(mCRC), after one or two prior lines of therapy for metastatic
disease. The NCCN based their recommendation on data from the
safety lead-in of the BEACON CRC trial evaluating the triplet
combination of BRAFTOVI in combination with MEKTOVI and ERBITUX
(cetuximab) in 29 patients with BRAFV600E-mutant
mCRC.
Safety Lead-in Median Overall Survival (OS) Data Presented
at ASCO 2019 Gastrointestinal Cancers
Symposium
Array announced updated safety and efficacy results from the
safety lead-in of the Phase 3 BEACON CRC trial evaluating the
triplet combination of BRAFTOVI, MEKTOVI, and ERBITUX in patients
with BRAFV600E-mutant mCRC.
- Mature median OS was 15.3 months (95% CI, 9.6–not reached) for
patients treated with the triplet.
- Updated median progression-fee survival (mPFS) and updated
confirmed overall response rate (ORR) results for patients treated
with the triplet in the safety lead-in remain the same, as
previously reported, with 8 months mPFS (95% CI, 5.6-9.3) and a 48%
ORR (95% CI, 29.4–67.5). ORR by central assessment, 41% (95% CI
24%–61%), was consistent with local assessment.
- The triplet combination was generally well-tolerated with no
unexpected toxicities. The most common grade 3 or 4 adverse events
seen in at least 10% of patients were fatigue (13%), anemia (10%),
increased creatine phosphokinase (10%), increased aspartate
aminotransferase (10%) and urinary tract infections (10%). The rate
of grade 3 or 4 skin toxicities continued to be lower than
generally observed with ERBITUX in mCRC.
Regulatory Update
Following consultation with the FDA
and European Medicines Agency, Array 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
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 this
quarter. 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 has completed enrollment.
ANCHOR CRC TRIAL
ANCHOR CRC, an international trial
designed to assess the efficacy and safety of the combination of
BRAFTOVI, MEKTOVI, and ERBITUX in patients with
BRAFV600E-mutant mCRC in the first-line setting,
is advancing. 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 for sites
outside of North America.
IMMUNO-ONCOLOGY COLLABORATIONS
Array is investigating
MEKTOVI 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 mCRC patients with
microsatellite stable tumors (BMS and Merck), and patients with
non-small cell lung cancer and pancreatic cancer
(Pfizer).
BRAFTOVI + MEKTOVI LIFE-CYCLE TRIAL MANAGEMENT
POLARIS
(NCT03911869), an open-label Phase 2 trial designed to assess the
efficacy and safety of the combination of BRAFTOVI + MEKTOVI in
patients with BRAFV600-mutant melanoma brain
metastasis, has been active since April
2019.
PHAROS (NCT03915951), an open-label Phase 2 trial designed to
assess the efficacy and safety of the combination of BRAFTOVI +
MEKTOVI in patients with BRAFV600E-mutant
metastatic non-small cell lung cancer, has been active since
April 2019.
FINANCIAL HIGHLIGHTS
Third Quarter of Fiscal 2019 Compared to Second Quarter of
Fiscal 2019
- Net Product Sales for BRAFTOVI + MEKTOVI for the third
quarter of fiscal 2019 were $35.1
million, compared to $22.7
million for the second quarter of fiscal 2019.
- Total Revenue for the third quarter of fiscal 2019 was
$64.7 million, compared to
$82.5 million for the prior quarter.
The decrease was primarily due to the recognition of the
Vitrakvi® milestones in the prior quarter.
- Research and Development Expense for the third quarter
of fiscal 2019 was $65.5 million,
compared to $62.1 million for the
prior quarter. The increase was primarily driven by proprietary
trial activities including the BEACON CRC trial, as well as other
BRAFTOVI + MEKTOVI life-cycle trials initiated in the quarter,
POLARIS and PHAROS.
- Selling, General and Administrative for the third
quarter of fiscal 2019 was $35.5
million, compared to $30.5
million for the prior quarter. The increase was mostly
driven by costs associated with BRAFTOVI + MEKTOVI commercial and
sales activities, as well as general corporate expenses.
- Net loss for the third quarter of fiscal 2019 was
($37.5 million), or ($0.17) per share, compared to ($11.4 million), or ($0.05) per share, for the prior quarter.
- Cash, cash equivalents and marketable securities as of
March 31, 2019 were $479 million.
CONFERENCE CALL INFORMATION
Array will hold a
conference call on Tuesday, May 7,
2019, 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, May 7,
2019
|
Time:
|
9:00 a.m. Eastern
Time
|
Toll-Free:
|
(844)
464-3927
|
Toll:
|
(765)
507-2598
|
Pass
Code:
|
3638409
|
Webcast, including Replay and Conference Call Slides:
https://edge.media-server.com/m6/p/bt2tyqof
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. [1,2] 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. [1-5]
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. In Japan, the combination is approved for
unresectable melanoma with a BRAF mutation.
Array has exclusive rights to BRAFTOVI and MEKTOVI in the U.S.
and Canada. Array has granted Ono
Pharmaceutical Co. Ltd., exclusive rights to commercialize both
products in Japan and South Korea, Medison Pharma Ltd. exclusive
rights to commercialize both products in Israel and Pierre Fabre Médicament exclusive
rights to commercialize both products in all other countries,
including Europe, Latin American
and Asia (excluding Japan and South
Korea).
BRAFTOVI + MEKTOVI have received regulatory approval in
the United States, European Union,
Australia and Japan. The Swiss Medicines Agency (Swissmedic)
is currently reviewing the Marketing Authorization Applications for
BRAFTOVI and MEKTOVI submitted by Pierre
Fabre.
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. See
full Prescribing Information for BRAFTOVI and for MEKTOVI for dose
modifications for adverse reactions.
Warnings and Precautions
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. Manage suspicious skin lesions with excision and
dermatopathologic evaluation. Dose modification is not recommended
for new primary cutaneous malignancies. Based on its mechanism of
action, BRAFTOVI may promote malignancies associated with
activation of RAS through mutation or other mechanisms. Monitor
patients receiving BRAFTOVI for signs and symptoms of non-cutaneous
malignancies. Discontinue BRAFTOVI for RAS mutation-positive
non-cutaneous malignancies.
Tumor Promotion in BRAF Wild-Type
Tumors: Confirm evidence of BRAFV600E or
V600K mutation prior to initiating BRAFTOVI.
Cardiomyopathy, manifesting as left ventricular
dysfunction associated with symptomatic or asymptomatic decreases
in ejection fraction, has been reported in patients. 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. 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.
Patients with cardiovascular risk factors should be monitored
closely.
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.
The most frequent hemorrhagic events were gastrointestinal,
including rectal hemorrhage (4.2%), hematochezia (3.1%), and
hemorrhoidal hemorrhage (1%).
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. RVO is a known
class-related adverse reaction of MEK inhibitors and may occur in
patients treated with MEKTOVI in combination with encorafenib. In
patients with BRAF mutation-positive melanoma across
multiple clinical trials, 0.1% of patients experienced retinal vein
occlusion (RVO). The safety of MEKTOVI has not been established in
patients with a history of RVO or current risk factors for RVO
including uncontrolled glaucoma or a history of hyperviscosity or
hypercoagulability syndromes. Perform ophthalmological evaluation
for patient-reported acute vision loss or other visual disturbance
within 24 hours. 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 ophthalmological evaluation at
regular intervals and for any visual disturbances, and to follow
new or persistent ophthalmologic findings.
Interstitial Lung Disease (ILD): ILD, including
pneumonitis occurred in 0.3% of patients with BRAF
mutation-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), and 0.5% for alkaline phosphatase. 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 and creatinine levels prior to
initiating MEKTOVI, periodically during treatment, and as
clinically indicated.
QTc Prolongation: BRAFTOVI is associated with
dose-dependent QTc interval prolongation in some patients. 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. BRAFTOVI can render
hormonal contraceptives ineffective. Non-hormonal 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. Avoid
co-administration of BRAFTOVI with medicinal products with a known
potential to prolong QT/QTc interval.
Please see full Prescribing Information for
BRAFTOVI and full Prescribing Information for
MEKTOVI for additional information. [6-7]
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 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. [8] In the U.S. alone, an
estimated 140,250 patients were diagnosed with cancer of the colon
or rectum in 2018, and approximately 50,000 are estimated to die of
their disease each year. [9] BRAF mutations are estimated to
occur in up to 15% of patients with mCRC and represent a poor
prognosis for these patients. [10-14] The V600 mutation is the most
common BRAF mutation and the risk of mortality in CRC
patients with the BRAFV600E mutation is more than
two times higher than for those with wild-type BRAF. [10,15]
Several irinotecan and cetuximab-containing regimens, similar to
the BEACON CRC control arm, have established observed historical
published 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 2 to
3 months and median OS of 4 to 6 months. [12-14,16-20]
BRAFV600E-mutant mCRC is an area of high unmet
need as there are currently no FDA-approved therapies specifically
indicated for patients with BRAF-mutant mCRC, and these
patients derive limited benefit from available chemotherapy
regimens. [21-23] For more information about
BRAFV600E-mutant mCRC visit www.brafmcrc.com.
About BEACON CRC
BEACON CRC is a randomized,
open-label, global trial evaluating the efficacy and safety of
BRAFTOVI, MEKTOVI and ERBITUX 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
ERBITUX per label). Of the 30 patients, 29 had a
BRAFV600 mutation. Microsatellite instability
high, 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 ERBITUX with or without MEKTOVI compared to
ERBITUX and irinotecan-based therapy. Approximately 615 patients
are expected to be randomized 1:1:1 to receive triplet combination,
doublet combination (BRAFTOVI and ERBITUX) or the control arm
(irinotecan-based therapy and ERBITUX). 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. Ltd., Pierre Fabre and Merck KGaA, Darmstadt,
Germany for sites outside of
North America.
The triplet combination of BRAFTOVI, MEKTOVI and ERBITUX for the
treatment of patients with BRAFV600E-mutant mCRC
is investigational and not approved by the FDA.
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
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
in the United States and with
partners in other major worldwide markets. 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 metastatic
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), LOXO-292 (partnered with
Eli Lilly), ipatasertib (partnered with Genentech), tucatinib
(partnered with Seattle Genetics) and ARRY-797.
Vitrakvi® (larotrectinib, partnered with Bayer AG) is
approved in the United States and
Ganovo® (danoprevir, partnered with Roche) is approved
in China. For more information on
Array, please visit www.arraybiopharma.com or follow
@arraybiopharma on Twitter and LinkedIn.
References
[1] A Snapshot of
Melanoma. National Cancer Institute. Available
at: https://seer.cancer.gov/statfacts/html/melan.html.
Accessed January 2018.
[2] Melanoma Skin Cancer. American Cancer Society. Available
at: https://www.cancer.org/cancer/melanoma-skin-cancer.html.
Accessed January 2018.
[3] Globocan 2012: Estimated Cancer Incidence, Mortality and
Prevalence Worldwide in
2012. http://globocan.iarc.fr/Pages/fact_sheets_population.aspx.
Accessed January 2018.
[4] Klein O, et al. Eur J Cancer, 2013.
[5] 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.
[6] BRAFTOVI® (encorafenib) Prescribing Information.
Array BioPharma Inc., June 2018.
[7] MEKTOVI® (binimetinib) Prescribing Information.
Array BioPharma Inc., June 2018.
[8] 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.
[9] 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.
[10] Sorbye, et al. PLoS One. 2015.
[11] Vecchione, et al. Cell. 2016.
[12] Saridaki, et al., PLoS One. 2013.
[13] Loupakis, et al., Br J Cancer. 2009.
[14] Corcoran, et al., Cancer Discovery. 2012.
[15] Safaee, et al. PLoS One. 2012.
[16] Kopetz, et al., ASCO 2017.
[17] De Roock, et al., Lancet Oncol. 2010.
[18] Ulivi, et al., J Transl Med. 2012.
[19] Peeters, et al., ASCO 2014.
[20] Seymour, et al., Lancet Oncol. 2013 (supplementary
appendix).
[21] NCCN Clinical Practice Guidelines in Oncology for Colon
Cancer. Version 4.2018. National Comprehensive Cancer
Network.
[22] Van Cutsem, et al., Annals of Oncology. 2016.
[23] Ursem, et al., Gastrointest Cancer, 2018.
® National Comprehensive Cancer Network, Inc. 2019. To view the
most recent and complete version of the guideline, go online to
NCCN.org.
NCCN makes no warranties of any kind whatsoever regarding their
content, use or application and disclaims any responsibility for
their application or use in any way.
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 as part of an accelerated or regular review
process of the triplet combination of encorafenib, binimetinib and
cetuximab; 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 May
7, 2019 . 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.
Erbitux® is a registered trademark of Eli Lilly and
Company. Vitrakvi® is a registered trademark of Bayer
AG. All trademarks are properties of their respective owners.
Array BioPharma
Inc.
|
Consolidated
Statements of Operations
|
(Unaudited)
|
(in thousands,
except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
|
|
|
|
|
March
31,
|
|
March
31,
|
|
|
|
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Revenue
|
|
|
|
|
|
|
|
|
|
|
Product sales,
net
|
|
|
$
35,078
|
|
$
-
|
|
$
71,784
|
|
$
-
|
|
Product
royalties
|
|
|
937
|
|
-
|
|
1,261
|
|
-
|
|
Collaboration and
license revenue
|
|
|
19,493
|
|
41,616
|
|
101,121
|
|
72,993
|
|
Reimbursement
revenue
|
|
|
9,169
|
|
24,751
|
|
29,970
|
|
65,338
|
|
|
Total
revenue
|
|
|
64,677
|
|
66,367
|
|
204,136
|
|
138,331
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
|
1,042
|
|
-
|
|
2,023
|
|
-
|
|
Research and
development
|
|
|
65,541
|
|
71,348
|
|
183,211
|
|
180,881
|
|
Selling, general and
administrative
|
|
|
35,548
|
|
16,773
|
|
90,911
|
|
40,428
|
|
|
Total operating
expenses
|
|
|
102,131
|
|
88,121
|
|
276,145
|
|
221,309
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
(37,454)
|
|
(21,754)
|
|
(72,009)
|
|
(82,978)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense)
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
2,912
|
|
1,295
|
|
6,722
|
|
3,075
|
|
Interest
expense
|
|
|
(2,863)
|
|
(2,361)
|
|
(8,261)
|
|
(8,407)
|
|
Other, net
|
|
|
(89)
|
|
(31)
|
|
(119)
|
|
(6,588)
|
|
|
Total other income
(expense), net
|
|
|
(40)
|
|
(1,097)
|
|
(1,658)
|
|
(11,920)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
|
|
$
(37,494)
|
|
$
(22,851)
|
|
$
(73,667)
|
|
$
(94,898)
|
Net loss per share
- basic and diluted
|
|
|
$
(0.17)
|
|
$
(0.11)
|
|
$
(0.34)
|
|
$
(0.49)
|
Weighted average
shares outstanding - basic and diluted
|
|
|
219,913
|
|
208,994
|
|
215,964
|
|
194,434
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Summary
Consolidated Balance Sheet Data
|
(Unaudited)
|
(in
thousands)
|
|
|
|
|
|
|
March 31,
2019
|
|
June 30,
2018
|
|
|
|
|
|
|
|
Cash, cash
equivalents and marketable securities
|
|
$
479,096
|
|
$
413,406
|
|
|
|
|
|
|
|
Working
capital
|
|
|
$
407,254
|
|
$
355,612
|
|
|
|
|
|
|
|
Total
assets
|
|
|
$
567,004
|
|
$
460,364
|
|
|
|
|
|
|
|
Long-term debt, net
and notes payable at fair value
|
$
134,245
|
|
$
111,775
|
|
|
|
|
|
|
|
Total stockholders'
equity
|
|
|
$
301,625
|
|
$
219,743
|
|
|
|
|
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.