SAN DIEGO, Aug. 4, 2016 /PRNewswire/ -- Orexigen
Therapeutics, Inc. (Nasdaq: OREX) today announced business and
financial results for the second quarter ended June 30, 2016.
"Earlier this week we completed our acquisition of U.S. rights
to Contrave®, transforming Orexigen into a fully
integrated commercial pharmaceutical company focused on our mission
to improve the health and lives of patients struggling to lose
weight," said Mike Narachi, CEO of
Orexigen. "With the completion of this acquisition and the
development of our independent commercialization capabilities over
the past several months, Orexigen is ready to execute on our
strategy to grow Contrave sales in the U.S. with our targeted
specialty sales force and to market Mysimba® and
Contrave outside the U.S. through multiple, regionally specific
partnerships."
Recent business highlights:
- Completed the acquisition of full rights to Contrave
(naltrexone HCl / bupropion HCl extended release) in the U.S. and
relaunched Contrave with a dedicated sales and marketing team on
August 1
- Received the Wholesale Distribution Authorisation from the
Irish Health Product Regulatory Authority, enabling Orexigen
Therapeutics Ireland Ltd. to ship product supply to distributor
partners in Europe. Valeant is
planning to launch Mysimba in 11 European Union countries by year
end 2016 and in Greece and
Cyprus in the first quarter of
2017
- Executed a commercialization and distributorship agreement with
Laboratorios Farmacéuticos Rovi, S.A. for Mysimba in Spain
- Announced launch of Contrave in South
Korea by partner Kwang Dong Pharmaceuticals
- Kwang Dong is now executing on a
comprehensive commercial plan that leverages their medical and
sales teams to target hospitals, clinics and physicians
- Reported favorable Markman ruling in Contrave patent litigation
- There are 10 Contrave patents listed in the Orange Book, the
last of which expires in 2032
- Promoted Thomas Cannell, D.V.M.,
to Chief Operating Officer and President of Global Commercial
Products, Jason Keyes to Chief
Financial Officer, and Peter Flynn,
Ph.D., to Head of Global Development, Regulatory and Safety
- The Company's senior executive leadership team is now in place
to take full control and responsibility for Contrave, and to manage
an effective and efficient U.S. sales and marketing organization in
addition to a growing number of partnerships around the world for
ex-U.S. commercialization of Contrave and Mysimba
Business and financial results for the three months ended
June 30, 2016
According to IMS Health, 191,033 prescriptions of Contrave were
filled in the second quarter of 2016.
For the three months ended June 30,
2016, Orexigen reported a net loss of $25.2 million, or $1.73 per share, as compared to a net loss of
$22.5 million, or $1.80 per share, for the second quarter of
2015.
Orexigen reported second quarter 2016 revenue of $7.8 million, including $2.5 million in royalties earned on U.S. net
sales of Contrave, $2.4 million in
collaborative income, and $2.9M in
net product sales to an ex-U.S. commercial partner. Total revenue
for the second quarter of 2015 was $5.2
million, including $3.1
million in royalties on net sales of Contrave.
Orexigen reported cost of product sales of
$1.8 million in the second
quarter of 2016 associated with its product sales to an ex-U.S.
commercial partner.
Total operating expenses for the second quarter of 2016 were
$39.2 million compared to
$25.9 million for the second quarter
of 2015. The increase was driven primarily by an increase in
SG&A associated with the hiring and build out of the global
commercial organization.
As of June 30, 2016, Orexigen had
$264.4 million in cash, restricted
cash and investments, and short term investments.
Conference Call Today at 2:00 p.m.
Pacific Time (5:00 p.m. Eastern
Time)
The Orexigen management team will host a teleconference and
webcast to discuss the second quarter 2016 financial results. The
live call may be accessed by phone by calling (888) 771-4371
(domestic) or (847) 585-4405 (international), participant code
42982061.
About Contrave and Mysimba
Contrave, approved by the United States Food and Drug
Administration in September 2014, is
indicated for use as an adjunct to a reduced-calorie diet and
increased physical activity for chronic weight management in adults
with an initial body mass index (BMI) of 30 kg/m2 or
greater (obese), or 27 kg/m2 or greater (overweight) in
the presence of at least one weight-related comorbid condition
(e.g., hypertension, type 2 diabetes mellitus or dyslipidemia). In
Europe, the medicine was approved
in March 2015 with the brand name
Mysimba.
The exact neurochemical effects of Contrave leading to weight
loss are not fully understood. Contrave has two components:
naltrexone, an opioid antagonist, and bupropion, a relatively weak
inhibitor of the neuronal reuptake of dopamine and norepinephrine.
Nonclinical studies suggest that naltrexone and bupropion have
effects on two separate areas of the brain involved in the
regulation of food intake: the hypothalamus (appetite regulatory
center) and the mesolimbic dopamine circuit (reward system).
Four 56-week multicenter, double-blind, placebo-controlled Phase
3 clinical trials were conducted to evaluate the effect of Contrave
in conjunction with lifestyle modification in 4,536 subjects
randomized to Contrave or placebo. In these studies, the most
common adverse reactions (≥5 percent) seen in patients taking
Contrave included nausea, constipation, headache, vomiting,
dizziness, insomnia, dry mouth, and diarrhea.
The clinical trial program also includes a double-blind,
placebo-controlled cardiovascular outcomes trial known as the Light
Study. The primary objective of this study was to evaluate the
occurrence of major adverse cardiovascular events (MACE) in
overweight and obese adults with cardiovascular risk factors
receiving Contrave. A second study, designed to address
post-approval requirements in both Europe and the
United States, is planned in order to further evaluate
cardiovascular outcomes.
Further information can be found at
http://www.orexigen.com/.
Important Safety Information for CONTRAVE and MYSIMBA
(naltrexone HCl and bupropion HCl) 8 mg/90 mg
extended-release tablets
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS; AND
NEUROPSYCHIATRIC REACTIONS
Suicidality and Antidepressant Drugs
Not approved for use in the treatment of major depressive
disorder or other psychiatric disorders. Contains bupropion, the
same active ingredient as some other antidepressant medications
(including, but not limited to, WELLBUTRIN, WELLBUTRIN SR,
WELLBUTRIN XL, and APLENZIN). Antidepressants increased the risk of
suicidal thoughts and behavior in children, adolescents, and young
adults in short-term trials. These trials did not show an increase
in the risk of suicidal thoughts and behavior with antidepressant
use in subjects over age 24; there was a reduction in risk with
antidepressant use in subjects aged 65 and older. In patients of
all ages, monitor closely for worsening, and for the emergence of
suicidal thoughts and behaviors. Advise families and caregivers of
the need for close observation and communication with the
prescriber. Not approved for use in pediatric patients.
Neuropsychiatric Reactions in Patients Taking Bupropion for
Smoking Cessation
Serious neuropsychiatric reactions have occurred in patients
taking bupropion for smoking cessation. The majority of these
reactions occurred during bupropion treatment, but some occurred in
the context of discontinuing treatment. In many cases, a causal
relationship to bupropion treatment is not certain, because
depressed mood may be a symptom of nicotine withdrawal. However,
some of the cases occurred in patients taking bupropion who
continued to smoke. Although not approved for smoking cessation,
observe all patients for neuropsychiatric reactions. Instruct the
patient to contact a healthcare provider if such reactions
occur.
Contraindications
Contraindicated in: uncontrolled hypertension; seizure
disorder or a history of seizures; use of other
bupropion-containing products; bulimia or anorexia nervosa, which
increase the risk for seizure; chronic opioid or opiate agonist
(e.g., methadone) or partial agonists (e.g., buprenorphine) use, or
acute opiate withdrawal; patients undergoing an abrupt
discontinuation of alcohol, benzodiazepines, barbiturates, and
antiepileptic drugs; use during/within 14 days following treatment
with monoamine oxidase inhibitors (MAOIs)—there is an increased
risk of hypertensive reactions when used concomitantly with MAOIs
and use with reversible MAOIs such as linezolid or intravenous
methylene blue is also contraindicated; known allergy to any
component, anaphylactoid/anaphylactic reactions and Stevens-Johnson
syndrome have been reported; pregnancy.
WARNINGS AND PRECAUTIONS
Suicidal Behavior and Ideation
All patients being treated with antidepressants for any
indication should be monitored appropriately and observed closely
for clinical worsening, suicidality, and unusual changes in
behavior, especially during the initial few months of a course of
drug therapy, or at times of dose changes, either increases or
decreases. This warning applies because one component, bupropion,
is a member of an antidepressant class.
Consideration should be given to changing the therapeutic
regimen, including possibly discontinuing the medication, in
patients whose depression is persistently worse, or who are
experiencing emergent suicidality or symptoms that might be
precursors to worsening depression or suicidality, especially if
these symptoms are severe, abrupt in onset, or were not part of the
patient's presenting symptoms.
Families and caregivers of patients being treated with
antidepressants for major depressive disorder or other indications,
both psychiatric and nonpsychiatric, should be alerted about the
need to monitor patients for the emergence of anxiety, agitation,
irritability, unusual changes in behavior, and other symptoms, as
well as the emergence of suicidality, and to report such symptoms
immediately to healthcare providers. Such monitoring should include
daily observation by families and caregivers. Prescriptions should
be written for the smallest quantity of tablets consistent with
good patient management, in order to reduce the risk of
overdose.
Neuropsychiatric Symptoms and Suicide Risk in Smoking
Cessation Treatment
Not approved for smoking cessation treatment, but serious
neuropsychiatric symptoms have been reported in patients taking
bupropion for smoking cessation. These have included changes in
mood (including depression and mania), psychosis, hallucinations,
paranoia, delusions, homicidal ideation, hostility, agitation,
aggression, anxiety, and panic, as well as suicidal ideation,
suicide attempt, and completed suicide. Observe patients for the
occurrence of neuropsychiatric reactions. Instruct patients to
contact a healthcare professional if such reactions occur.
Seizures
Can cause seizures. The risk of seizure is dose-related.
Discontinue treatment and do not restart in patients who experience
a seizure. Caution should be used when prescribing to patients with
predisposing factors that may increase the risk of seizure,
including: history of head trauma or prior seizure, severe stroke,
arteriovenous malformation, central nervous system tumor or
infection, or metabolic disorders (e.g., hypoglycemia,
hyponatremia, severe hepatic impairment, and hypoxia); excessive
use of alcohol or sedatives, addiction to cocaine or stimulants, or
withdrawal from sedatives; patients with diabetes treated with
insulin and/or oral diabetic medications (sulfonylureas and
meglitinides) that may cause hypoglycemia; concomitant
administration of medications that may lower the seizure threshold,
including other bupropion products, antipsychotics, tricyclic
antidepressants, theophylline, systemic steroids.
Clinical experience with bupropion suggests that the risk of
seizure may be minimized by adhering to the recommended dosing
recommendations, in particular: the total daily dose does not
exceed 360 mg of the bupropion component (i.e., four tablets per
day); the daily dose is administered in divided doses (twice
daily); the dose is escalated gradually; no more than two tablets
are taken at one time; coadministration with high-fat meals is
avoided; if a dose is missed, a patient should wait until the next
scheduled dose to resume the regular dosing schedule.
Patients Receiving Opioid Analgesics
Vulnerability to Opioid Overdose: Should not be administered to
patients receiving chronic opioids, due to the naltrexone
component, which is an opioid receptor antagonist. If chronic
opiate therapy is required, treatment should be stopped. In
patients requiring intermittent opiate treatment, therapy should be
temporarily discontinued and lower doses of opioids may be needed.
Patients should be alerted that they may be more sensitive to
opioids, even at lower doses, after treatment is discontinued. An
attempt by a patient to overcome any naltrexone opioid blockade by
administering large amounts of exogenous opioids is especially
dangerous and may lead to a fatal overdose or life-threatening
opioid intoxication (e.g., respiratory arrest, circulatory
collapse). Patients should be told of the serious consequences of
trying to overcome the opioid blockade.
Precipitated Opioid Withdrawal: An opioid-free interval of a
minimum of 7 to 10 days is recommended for patients previously
dependent on short-acting opioids, and those patients transitioning
from buprenorphine or methadone may need as long as two weeks.
Patients should be made aware of the risks associated with
precipitated withdrawal and encouraged to give an accurate account
of last opioid use.
Increase in Blood Pressure (BP) and Heart Rate (HR)
Can cause an increase in systolic BP, diastolic BP, and/or
resting HR. These events were observed in both patients with and
without evidence of preexisting hypertension. In clinical practice
with other bupropion-containing products, hypertension, in some
cases severe and requiring acute treatment, has been reported.
Blood pressure and pulse should be measured prior to starting
therapy with CONTRAVE and should be monitored at regular intervals
consistent with usual clinical practice, particularly among
patients with cardiac or cerebrovascular disease and/or with
controlled hypertension prior to treatment.
Allergic Reactions
Anaphylactoid/anaphylactic reactions and symptoms suggestive of
delayed hypersensitivity have been reported with bupropion, as well
as rare spontaneous reports of erythema multiforme, Stevens-Johnson
syndrome, and anaphylactic shock. Instruct patients to discontinue
and consult a healthcare provider if they develop an allergic or
anaphylactoid/anaphylactic reaction (e.g., skin rash, pruritus,
hives, chest pain, edema, or shortness of breath) during this
treatment.
Hepatotoxicity
Cases of hepatitis, clinically significant liver dysfunction,
and transient asymptomatic hepatic transaminase elevations have
been observed with naltrexone exposure. Patients should be warned
of the risk of hepatic injury and advised to seek medical attention
if they experience symptoms of acute hepatitis. Discontinue in the
event of symptoms/signs of acute hepatitis.
Activation of Mania
Bupropion is a drug used for the treatment of depression.
Antidepressant treatment can precipitate a manic, mixed, or
hypomanic episode. The risk appears to be increased in patients
with bipolar disorder or who have risk factors for bipolar
disorder. Prior to initiating therapy, screen patients for history
of bipolar disorder and the presence of risk factors for bipolar
disorder (e.g., family history of bipolar disorder, suicide, or
depression). Not approved for use in treating bipolar
depression.
Angle-Closure Glaucoma
The pupillary dilation that occurs following use of many
antidepressant drugs, including bupropion, may trigger an
angle-closure attack in a patient with anatomically narrow angles
who does not have a patent iridectomy.
Hypoglycemia with Use of Antidiabetic Medications
Weight loss may increase the risk of hypoglycemia in patients
with type 2 diabetes mellitus treated with insulin and/or insulin
secretagogues (e.g., sulfonylureas). Measurement of blood glucose
levels prior to starting therapy and during treatment is
recommended in patients with type 2 diabetes. Decreases in
medication doses for antidiabetic medications which are
non-glucose-dependent should be considered to mitigate the risk of
hypoglycemia.
Adverse Reactions
Most common adverse reactions (>5%) include: nausea (32.5%),
constipation (19.2%), headache (17.6%), vomiting (10.7%), dizziness
(9.9%), insomnia (9.2%), dry mouth (8.1%), and diarrhea (7.1%).
Drug Interactions
Increased risk of hypertensive reactions can occur when used
concomitantly with MAOIs. Use caution and consider dose reduction
of drugs metabolized by CYP2D6. Avoid concomitant use with CYP2B6
inducers. Reduce dose when taken with CYP2B6 inhibitors. Dose with
caution when used with drugs that lower seizure threshold. Use
caution and monitor for CNS toxicity when using concomitantly with
dopaminergic drugs (levodopa and amantadine). Can cause false
positive urine test results for amphetamines.
Indication and Usage for Contrave in the United States
CONTRAVE is indicated as an adjunct to a reduced-calorie diet
and increased physical activity for chronic weight management in
adults with an initial body mass index (BMI) of:
30 kg/m2 or greater (obese) or
27 kg/m2 or greater (overweight) in the presence of at least one
weight-related comorbidity (e.g., hypertension, type 2 diabetes
mellitus, or dyslipidemia)
Limitations of Use
The effect of CONTRAVE on cardiovascular morbidity and mortality
has not been established. The safety and effectiveness of CONTRAVE
in combination with other products intended for weight loss,
including prescription drugs, over-the-counter drugs, and herbal
preparations, have not been established.
Please see accompanying full Prescribing Information and
Medication Guide for CONTRAVE.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit
http://www.accessdata.fda.gov, or call 1-800-FDA-1088.
Indication and Usage of MYSIMBA in the European Union
MYSIMBA is indicated, as an adjunct to a reduced-calorie diet
and increased physical activity, for the management of weight in
adult patients (≥18 years) with an initial Body Mass Index (BMI)
of
- ≥ 30 kg/m2 (obese), or
- ≥ 27 kg/m2 to < 30 kg/m2 (overweight)
in the presence of one or more weight-related co‑morbidities (e.g.,
type 2 diabetes, dyslipidaemia, or controlled hypertension)
Treatment with MYSIMBA should be discontinued after 16 weeks if
patients have not lost at least 5% of their initial body
weight.
Please see Summary of Product Characteristics
and more information about MYSIMBA for EU patients available
at:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003687/human_med_001845.jsp&mid=WC0b01ac058001d124
Mysimba™ and Contrave® are trademarks of Orexigen
Therapeutics, Inc. registered with the U.S. Patent and Trademark
Office.
About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company
focused on the treatment of obesity. Orexigen developed
Contrave® (naltrexone HCl and bupropion HCl extended
release), which is approved in the United
States and is being commercialized there by the company's
U.S. partner, Takeda Pharmaceuticals. In Europe the drug has been approved under the
brand name MysimbaTM (naltrexone HCl/ bupropion HCl
prolonged release). Orexigen's strategy for Contrave/Mysimba is to
pursue marketing authorizations worldwide and pharmaceutical
partnerships for global commercialization. Further information
about the Company can be found at http://www.orexigen.com/.
Forward-Looking Statements
Orexigen cautions you that statements included in this press
release that are not a description of historical facts are
forward-looking statements. Words such as "believes,"
"anticipates," "plans," "expects," "indicates," "will," "should,"
"intends," "potential," "suggests," "assuming," "designed" and
similar expressions are intended to identify forward-looking
statements. These statements are based on the Company's current
beliefs and expectations. These forward-looking statements include
statements regarding: the potential to grow Contrave sales in the
U.S. with the Company's targeted speciality sales force and to
market Mysimba and Contrave outside the U.S. through multiple,
regionally specific partnerships; the potential for and timing of
commercialization of Mysimba in certain Eastern European countries
by the Company's distribution partner; the ability of the Company's
senior executive leadership team to manage an effective and
efficient U.S. sales and marketing organization in addition to a
growing number of partnerships around the world for ex-U.S.
commercialization of Contrave and Mysimba; and the potential to
enter into additional partnerships around the world for ex-U.S.
commercialization of Contrave and Mysimba. The inclusion of
forward‐looking statements should not be regarded as a
representation by Orexigen that any of its plans will be achieved.
Actual results may differ materially from those expressed or
implied in this release due to the risk and uncertainties inherent
in the Orexigen business, including, without limitation: the
potential that the marketing and commercialization of Contrave and
Mysimba will not be successful; the ability to obtain partnerships
and marketing authorizations globally; competition in the global
obesity market, particularly from existing therapies; additional
analysis of the interim results or the final data from the
terminated Light Study, including safety-related data, and the
additional CVOT may produce negative or inconclusive results, or
may be inconsistent with the conclusion that the interim analysis
was successful; our ability to retain ownership of Contrave and
Mysimba and create value in certain markets outside of the United States; our ability to obtain and
maintain global intellectual property protection for Contrave and
Mysimba; the potential that the interim analysis of the Light Study
may not be predictive of future results in the Light Study or other
clinical trials; legal or regulatory proceedings against Orexigen,
as well as potential reputational harm, as a result of misleading
public claims about Orexigen; the therapeutic and commercial value
of Contrave and Mysimba; our ability to successfully acquire,
develop and market additional product candidates or approved
products; our ability to maintain sufficient capital to fund our
operations for the foreseeable future; estimates of the capacity of
manufacturing and other facilities to support Contrave; the
Company's ability to vigorously enforce the CONTRAVE intellectual
property rights; the potential for a Delaware court to determine that one or more
of the patents are not valid or that Actavis' proposed generic
product is not infringing each of the patents at issue; and other
risks described in Orexigen's filings with the Securities and
Exchange Commission. You are cautioned not to place undue reliance
on these forward‐looking statements, which speak only as of the
date hereof, and Orexigen undertakes no obligation to revise or
update this news release to reflect events or circumstances after
the date hereof. Further information regarding these and other
risks is included under the heading "Risk Factors" in Orexigen's
Annual Report on Form 10-K we filed with the Securities and
Exchange Commission on or about February 26,
2016 and its other reports, which are available from the
SEC's website (www.sec.gov) and on Orexigen's website
(www.orexigen.com) under the heading "Investors." All
forward‐looking statements are qualified in their entirety by this
cautionary statement. This caution is made under the safe harbor
provisions of Section 21E of the Private Securities Litigation
Reform Act of 1995.
Orexigen Contact:
McDavid Stilwell VP, Corporate
Communications and Business Development
(858) 875-8629
Media Contact:
Julie Normart, BrewLife
(415) 946-1087
Orexigen
Therapeutics, Inc.
|
|
Statements of
Operations
|
|
(In thousands, except
per share amounts)
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
Six Months
Ended
|
|
|
June
30,
|
June
30,
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
Collaborative
agreement
|
|
$
|
2,403
|
|
$
|
2,057
|
|
$
|
4,794
|
|
$
|
4,114
|
Royalties
|
|
|
2,453
|
|
|
3,137
|
|
|
5,095
|
|
|
5,439
|
Net product
sales
|
|
|
2,935
|
|
|
-
|
|
|
2,935
|
|
|
-
|
Total
revenues
|
|
7,791
|
|
5,194
|
|
12,824
|
|
9,553
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product
sales
|
|
|
1,784
|
|
|
-
|
|
|
1,784
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
14,249
|
|
15,107
|
|
26,050
|
|
26,349
|
Selling, general and
administrative
|
|
24,991
|
|
10,815
|
|
41,542
|
|
19,399
|
Total operating
expenses
|
|
39,240
|
|
25,922
|
|
67,592
|
|
45,748
|
Loss from
operations
|
|
(33,233)
|
|
(20,728)
|
|
(56,552)
|
|
(36,195)
|
Interest and other
(expense) income, net:
|
|
|
|
|
|
|
|
|
Interest
income
|
|
163
|
|
67
|
|
286
|
|
130
|
Interest
expense
|
|
|
(1,954)
|
|
|
(1,843)
|
|
(3,890)
|
|
(3,672)
|
Change in fair value
of financial instruments
|
|
|
11,600
|
|
|
-
|
|
11,600
|
|
-
|
Foreign currency gain
(loss), net
|
|
(1,806)
|
|
-
|
|
978
|
|
-
|
Total interest and
other (expense) income, net
|
|
8,003
|
|
(1,776)
|
|
8,974
|
|
(3,542)
|
Net
loss
|
|
$
|
(25,230)
|
|
$
|
(22,504)
|
|
$
|
(47,578)
|
|
$
|
(39,737)
|
|
|
|
|
|
|
|
|
|
|
Net loss per share -
basic and diluted
|
|
$
|
(1.73)
|
|
$
|
(1.80)
|
|
$
|
(3.27)
|
|
$
|
(3.19)
|
Shares used in
computing net loss per share – basic and diluted
|
|
14,566
|
|
12,519
|
|
14,561
|
|
12,454
|
Orexigen
Therapeutics, Inc.
|
Consolidated Balance
Sheets
|
(In thousands, except
share and par value amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June
30,
|
|
December
31,
|
|
2016
|
|
2015
|
|
(Unaudited)
|
|
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
78,173
|
|
$
155,422
|
Accounts
receivable
|
2,922
|
|
6,828
|
Investment
securities, available-for-sale
|
20,983
|
|
58,589
|
Restricted cash and
investments
|
165,203
|
|
-
|
Inventory
|
11,458
|
|
10,802
|
Prepaid expenses and
other current assets
|
3,965
|
|
2,254
|
Total current
assets
|
282,704
|
|
233,895
|
Property and
equipment, net
|
1,377
|
|
1,284
|
Prepaid purchase
price - Contrave
|
60,000
|
|
-
|
Other long-term
assets
|
1,210
|
|
1,013
|
Restricted
cash
|
138
|
|
138
|
Total
assets
|
$
345,429
|
|
$
236,330
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
4,105
|
|
$
6,485
|
Accrued clinical
trial expenses
|
10,516
|
|
5,820
|
Accrued
expenses
|
10,551
|
|
10,323
|
Deferred revenue,
current portion
|
9,600
|
|
9,613
|
Total current
liabilities
|
34,772
|
|
32,241
|
Long-term convertible
debt
|
90,142
|
|
87,870
|
Long-term convertible
debt, at fair value
|
116,300
|
|
-
|
Warrant liability, at
fair value
|
33,100
|
|
-
|
Deferred revenue,
less current portion
|
77,737
|
|
82,691
|
Other long-term
liabilities
|
37
|
|
150
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
|
Series Z preferred
stock, $0.001 par value, 219,994 and no shares issued and
outstanding at March 31, 2016 and
December 31, 2015, respectively
|
3,343
|
|
-
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
Preferred stock,
$0.001 par value, 10,000,000 shares authorized at June 30, 2016 and December 31,
2015; 219,994 and no shares issued
and outstanding at June 30,
2016 and December 31, 2015, respectively
|
-
|
|
-
|
Common stock, $0.001
par value, 300,000,000 shares
authorized at June 30, 2016 and December 31, 2015;
14,586,780 and 14,554,592 shares
issued and outstanding at June 30, 2016
and December 31, 2015,
respectively
|
15
|
|
15
|
Additional paid-in
capital
|
659,129
|
|
653,835
|
Accumulated other
comprehensive income (loss)
|
(881)
|
|
215
|
Accumulated
deficit
|
(668,265)
|
|
(620,687)
|
Total stockholders'
equity
|
(10,002)
|
|
33,378
|
Total liabilities and
stockholders' equity
|
$
345,429
|
|
$
236,330
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/orexigen-therapeutics-reports-business-and-financial-results-for-the-second-quarter-ended-june-30-2016-300309376.html
SOURCE Orexigen Therapeutics, Inc.