SAN DIEGO, March 28, 2017 /PRNewswire/ -- Orexigen
Therapeutics, Inc. (Nasdaq: OREX) today announced business and
financial results for the fourth quarter and year ended
December 31, 2016.
"Last year was a year of transformational progress for Orexigen,
beginning with the re-acquisition of the rights to Contrave® in
the United States. Commencing
early March, the team at Orexigen demonstrated remarkable focus,
executing on a myriad of projects and deals which reshaped and
strengthened our Company while rewarding us full control of our FDA
approved product," said Mike
Narachi, CEO of Orexigen. "Last year we built a
fully-operational, high-quality commercial infrastructure in a
matter of months. We re-positioned Contrave to focus on the
attributes that we believe mattered most to patients, and launched
an impactful, broadly-integrated patient campaign along with
direct-to-consumer advertising in December. With an established
platform to drive growth, and an unwavering commitment to our
mission of helping improve the health and lives of patients
struggling to lose weight, we are excited for the remainder of
2017."
Adding to Mike's comments, Dr. Thomas
Cannell, Chief Operating Officer and President of Global
Commercial Products said, "As a result of the efforts that began in
2016, early 2017 prescription trends for Contrave in the United States appear to have entered a new
phase of growth. By the first week of March, prescription volumes
exceeded their prior peak and continue to trend above prior highs–
all with approximately half the average annual commercial spend
invested during the first two years on the market. Outside
the United States we continue to
make substantial progress for the Contrave / Mysimba brand, which
is now partnered in 39 total countries."
Looking ahead to the rest of 2017, Orexigen is firmly committed
to growing global net sales of the Contrave / Mysimba brand,
carefully managing operating expenses, and continuing to support
patients in innovative and effective ways, like better assisting
patient access through the nationwide expansion of a digital health
platform, telemedicine pilot and home-delivery pharmacy.
2016 business highlights:
- Acquired the U.S. rights to Contrave from Takeda in a deal
announced on March 15, 2016
- Raised $165 million in a
convertible note offering, with proceeds intended to fund the
acquisition and commercialization of Contrave in the U.S.
- Built a robust commercial infrastructure for Orexigen in the
U.S., including a dedicated sales force of 160 contract sales
professionals
- Transferred responsibility for U.S. Post Marketing Required
(PMR) clinical studies and Regulatory/Pharmacovigilance
reporting from Takeda to Orexigen and continued delivery of
high-quality PMR data, on schedule, to meet the requirements of
U.S. and EU regulatory authorities
- Launched a new physician-centered campaign with the Orexigen
sales force on August 1, 2016
- Launched a new patient-focused campaign with direct-to-consumer
advertising on December 26, 2016,
leveraging high-profile television, print and digital media
outlets
- Launched an innovative telemedicine pilot program to enable
online physician consultation, diagnosis, prescription issuance and
fulfilment, and home delivery of Contrave in California and Texas
- Signed partnerships spanning 37 additional countries; key
territories include Central and Eastern
Europe, Spain, the
United Kingdom, Ireland, Australia, New
Zealand and the Middle
East
- Announced early-stage development programs targeting two
high-profile therapeutic areas: analgesia, with reduced addiction
and abuse potential, and medication-assisted addiction
management
- Reduced outstanding indebtedness on favorable terms through an
open-market purchase and retirement of $35
million of 2.75% convertible notes
Business and financial results for the three months ended
December 31, 2016
According to IMS Health, 140,755 total prescriptions of
Contrave® (naltrexone HCl and bupropion HCl extended-release
tablets) were filled in the fourth quarter of 2016, as compared to
185,944 total prescriptions filled in the fourth quarter of
2015.
Orexigen reported fourth quarter 2016 revenue of $13.9 million, as compared to $4.9 million in the fourth quarter of 2015. The
increase was primarily attributable to Orexigen recording U.S. net
sales of Contrave as a result of acquiring U.S. rights to Contrave
from Takeda, whereas in the fourth quarter of 2015 Orexigen's
revenue included royalties earned on Takeda's sales of Contrave in
the U.S.
Total operating expenses for the fourth quarter of 2016 were
$52.6 million compared to
$17.8 million for the fourth quarter
of 2015. This overall increase in operating expense was due
primarily to an increase in costs to establish and manage sales,
marketing and distribution capabilities associated with
commercializing Contrave in the United
States, including the launch of the national, dynamic
direct-to-consumer advertising campaign. In addition, the fourth
quarter of 2016 also included $3.9
million of non-cash expense from the amortization of
intangible assets and a change in the fair market value of
contingent consideration related to the acquisition of Contrave in
2016.
For the three months ended December 31,
2016, Orexigen reported a net loss of $24.6 million, or $1.69 per share, as compared to a net loss of
$17.8 million, or $1.22 per share, for the fourth quarter of
2015.
Financial results for the year ended December 31, 2016
Annualized prescription data from IMS Health indicated 691,279
total prescriptions for Contrave were filled in 2016, as compared
to 665,388 total prescriptions filled in 2015.
Revenues for the year ended December 31,
2016 increased to $33.7
million from $24.5 million in
2015. The increase of approximately $9.2
million was primarily due to $22.0
million of net sales being recorded by Orexigen in 2016,
offset by a $4.7 million decrease in
royalties and an $8.1 million
decrease in milestone amortization revenue resulting from our
acquisition of Contrave last year.
Total operating expenses for 2016 were $82.7 million, including a one-time, non-cash
settlement gain of $80.2 million
which resulted from the elimination of previously-recorded,
pre-existing deferred revenue. That deferred revenue was associated
with upfront and launch milestone payments received in prior years
from Takeda, which were being amortized into revenue over the
estimated life of the Takeda collaboration. As a result of the
completed acquisition of U.S. rights to Contrave, the remaining
balance was eliminated and recorded as a non-cash gain in operating
expense in 2016. Excluding this non-cash gain, and other business
combination accounting adjustments totaling $6.3 million, operating expenses would have been
$156.6 million in 2016 compared to
$84.5 million for 2015. The increase
was driven primarily by SG&A expenses associated with the
hiring and building out of the commercial organization and the
launch of Contrave by Orexigen's own sales and marketing team. A
reconciliation of full year 2016 GAAP to non-GAAP operating expense
is presented at the end of this press release.
For the year ended December 31,
2016, Orexigen reported a net loss of $24.5 million, or $1.68 per share, as compared to a net loss of
$68.7 million, or $5.24 per share for 2015. The 2016 net loss
benefitted from the above-mentioned non-cash gain related to
deferred revenue, and other one-time events including a non-cash
gain associated with the repurchase of convertible debt in
December.
As of December 31, 2016, Orexigen
had $182.5 million in cash,
restricted cash and investments and an additional $11.5 million in marketable securities, for a
total of $194.0 million.
Non-GAAP Financial Measures
This press release includes information relating to non-GAAP
operating expense, which the Securities and Exchange Commission has
defined as a "non-GAAP financial measure." Non-GAAP operating
expense has been included in this press release because it
disregards certain one-time non-recurring accounting charges and
therefore aids Orexigen management and its board of directors in
understanding and comparing the financial performance for the
quarter to core operating performance and trends, and to develop
short- and long-term operational plans. The presentation of this
financial information, which is not prepared under any
comprehensive set of accounting rules or principles, is not
intended to be considered in isolation or as a substitute for the
financial information prepared and presented in accordance with
generally accepted accounting principles in the United States ("GAAP").
Non-GAAP operating expense has limitations as an analytical
tool, and you should not consider it in isolation or as a
substitute for analysis of Orexigen's financial results as reported
under GAAP. For example, non-GAAP operating expense does not take
into account certain non-recurring non-cash charges associated with
the acquisition of the rights to Contrave from Takeda.
Because of these limitations, you should consider non-GAAP
operating expense alongside other financial performance measures,
including GAAP operating expense. For a reconciliation of
non-GAAP financial measures to the nearest comparable GAAP
measures, see the non-GAAP reconciliations included below in this
press release.
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 fourth quarter and full year 2016 financial
results and recent business highlights. The live call may be
accessed by phone by calling (888) 771-4371 (domestic) or (847)
585-4405 (international), participant code 44520315. The
webcast can be accessed live on the "Investors" section of the
Orexigen web site at http://www.orexigen.com, and will be archived
for 14 days following the call.
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
the European Union, 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.contrave.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
www.fda.gov/medwatch, 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's first product,
Contrave® (naltrexone HCl and bupropion HCl extended release), was
approved in the United States in
September 2014 and became the most
prescribed branded obesity medication in the United States in June 2015. In the European Union, the drug has
been approved under the brand name Mysimba® (naltrexone HCl/
bupropion HCl prolonged release). Orexigen is undertaking a range
of development and commercialization activities, both on its own
and with strategic partners, to bring Contrave / Mysimba to
patients around the world. Further information about Orexigen
can be found at 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 success of marketing and
commercialization of Contrave/Mysimba in the United States and elsewhere; the potential
growth of Contrave/Mysimba prescriptions in 2017; the Company's
strategic plans and initiatives; the potential for Orexigen and its
partners to obtain regulatory approvals for and successfully
commercialize Contrave and Mysimba in additional markets outside
the United States; the potential
success of the Company's pilot telemedicine program; the potential
timing and success of a home-delivery pharmacy program; and the
potential to maximize operational efficiencies by carefully
managing operating expenses. 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/Mysimba will not be successful,
particularly, with respect to Contrave, in the U.S. following the
launch of the patient-focused marketing campaign; the Company's
ability to obtain and maintain partnerships and marketing
authorization globally; our ability to adequately inform consumers
about Contrave; our ability to successfully commercialize Contrave
with a specialty sales force in the
United States; our ability to successfully complete the
post-marketing requirement studies for Contrave; the capabilities
and performance of various third parties on which we rely for a
number of activities related to the manufacture, development and
commercialization of Contrave/Mysimba; the therapeutic and
commercial value of Contrave/Mysimba; competition in the global
obesity market, particularly from existing and generic therapies;
the Company's failure to successfully acquire, develop and market
additional product candidates or approved products; our ability to
obtain and maintain global intellectual property protection for
Contrave and Mysimba; legal or regulatory proceedings against
Orexigen, as well as potential reputational harm, as a result of
misleading public claims about Orexigen; our ability to maintain
sufficient capital to fund our operations for the foreseeable
future; 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 will be included under the heading "Risk Factors" in
Orexigen's Annual Report on Form 10‑K which we intend to file with
the Securities and Exchange Commission on or about March 29, 2017 and its other reports, which are
available from the SEC's website (www.sec.gov) and on Orexigen's
web site (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 Investor Contact:
Jason Keyes, Chief Financial
Officer
+1-858- 875-8600
ir@orexigen.com
Orexigen Media Contact:
Erika Hackmann
Y&R
+1-917-538-3375
erika.hackmann@yr.com
Orexigen
Therapeutics, Inc.
|
Consolidated
Balance Sheets
|
(In thousands,
except share and par value amounts)
|
|
|
|
December 31,
2016
|
|
December 31,
2015
|
|
|
(Unaudited)
|
|
|
Assets
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
92,494
|
|
$
155,422
|
Accounts
receivable
|
|
1,102
|
|
6,828
|
Investment
securities, available-for-sale
|
|
11,499
|
|
58,589
|
Restricted cash and
investments
|
|
90,005
|
|
—
|
Inventory
|
|
23,193
|
|
10,802
|
Prepaid expenses and
other current assets
|
|
6,168
|
|
2,254
|
Total current
assets
|
|
224,461
|
|
233,895
|
Property and
equipment, net
|
|
1,044
|
|
1,284
|
Intangible
assets
|
|
76,061
|
|
—
|
Other long-term
assets
|
|
2,835
|
|
1,013
|
Restricted
cash
|
|
188
|
|
138
|
Total
assets
|
|
$
304,589
|
|
$
236,330
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
15,210
|
|
$
6,485
|
Accrued clinical
trial expenses
|
|
—
|
|
5,820
|
Accrued
expenses
|
|
30,412
|
|
10,323
|
Contingent
consideration
|
|
15,000
|
|
—
|
Deferred revenue,
current portion
|
|
4,738
|
|
9,613
|
Total current
liabilities
|
|
65,360
|
|
32,241
|
Long-term contingent
consideration
|
|
6,800
|
|
—
|
Long-term convertible
debt
|
|
64,279
|
|
87,870
|
Long-term convertible
debt, at fair value
|
|
101,900
|
|
—
|
Deferred revenue,
less current portion
|
|
5,863
|
|
82,691
|
Other long-term
liabilities
|
|
—
|
|
150
|
Commitments and
contingencies
|
|
|
|
|
Series Z preferred
stock, $.001 par value, 219,994 and no shares issued and
outstanding at December 31, 2016 and December 31, 2015,
respectively
|
|
3,343
|
|
—
|
Stockholders'
equity:
|
|
|
|
|
Preferred stock,
$0.001 par value, 10,000,000 shares authorized at December 31, 2016
and 2015, 219,994 shares and no shares issued and outstanding at
December 31, 2016 and 2015, respectively
|
|
—
|
|
—
|
Common stock, $0.001
par value, 300,000,000 shares authorized at December 31, 2016 and
2015; 14,616,751 and 14,554,592 shares issued and outstanding at
December 31, 2016 and 2015, respectively
|
|
15
|
|
15
|
Additional paid-in
capital
|
|
698,229
|
|
653,835
|
Accumulated other
comprehensive income (loss)
|
|
4,011
|
|
215
|
Accumulated
deficit
|
|
(645,211)
|
|
(620,687)
|
Total stockholders'
equity
|
|
57,044
|
|
33,378
|
Total liabilities and
stockholders' equity
|
|
$
304,589
|
|
$
236,330
|
Orexigen
Therapeutics, Inc.
|
Statements of
Operations
|
(In thousands,
except per share amounts)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
December 31,
|
|
Year Ended
December 31,
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
Revenues:
|
|
|
|
|
|
|
|
|
Collaborative
agreement
|
|
$
76
|
|
$
2,340
|
|
$
5,795
|
|
$
13,865
|
Royalties
|
|
—
|
|
2,592
|
|
5,931
|
|
10,594
|
Net product
sales
|
|
13,807
|
|
—
|
|
21,983
|
|
—
|
Total
revenues
|
|
13,883
|
|
4,932
|
|
33,709
|
|
24,459
|
Cost of product
sales
|
|
4,271
|
|
—
|
|
7,995
|
|
—
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
6,719
|
|
5,584
|
|
38,023
|
|
40,750
|
Selling, general and
administrative
|
|
41,938
|
|
12,260
|
|
118,583
|
|
43,762
|
Pre-existing
settlement gain
|
|
—
|
|
—
|
|
(80,229)
|
|
—
|
Amortization expense
of intangible assets
|
|
1,899
|
|
—
|
|
3,307
|
|
—
|
Change in fair value
of contingent consideration
|
|
2,000
|
|
—
|
|
3,000
|
|
—
|
Total operating
expenses
|
|
52,556
|
|
17,844
|
|
82,684
|
|
84,512
|
Loss from
operations
|
|
(42,944)
|
|
(12,912)
|
|
(56,970)
|
|
(60,053)
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Interest
income
|
|
97
|
|
32
|
|
622
|
|
227
|
Interest
expense
|
|
(1,972)
|
|
(1,902)
|
|
(7,850)
|
|
(7,446)
|
Change in fair value
of financial instruments
|
|
7,700
|
|
—
|
|
25,400
|
|
—
|
Foreign currency gain
(loss), net
|
|
(5,644)
|
|
(1,651)
|
|
(3,880)
|
|
(39)
|
Gain on
extinguishment of debt
|
|
18,287
|
|
—
|
|
18,287
|
|
—
|
Total other income
(expense)
|
|
18,468
|
|
(3,521)
|
|
32,579
|
|
(7,258)
|
Net loss before
income taxes
|
|
(24,476)
|
|
(16,433)
|
|
(24,391)
|
|
(67,311)
|
Income
taxes
|
|
133
|
|
1,376
|
|
133
|
|
1,376
|
Net loss
|
|
$ (24,609)
|
|
$ (17,809)
|
|
$ (24,524)
|
|
$ (68,687)
|
Net loss per share -
basic and diluted
|
|
$
(1.69)
|
|
$
(1.22)
|
|
$
(1.68)
|
|
$
(5.24)
|
Shares used in
computing net loss per share - basic and diluted
|
|
14,594
|
|
14,548
|
|
14,576
|
|
13,113
|
Orexigen
Therapeutics, Inc.
|
Reconciliation of
GAAP to Non-GAAP
|
(In
thousands)
|
(Unaudited)
|
|
|
|
|
|
|
|
Three Months Ended
December 31,
|
|
|
2016
|
|
2015
|
GAAP Operating
expenses
|
|
$
(52,556)
|
|
$ (17,844)
|
Adjustments:
|
|
|
|
|
Amortization expense
of intangible assets
|
|
1,899
|
|
—
|
Change in fair value
of contingent consideration
|
|
2,000
|
|
—
|
Adjusted Non-GAAP
Operating expenses
|
|
$
(48,657)
|
|
$ (17,844)
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended
December 31,
|
|
|
2016
|
|
2015
|
GAAP Operating
expenses
|
|
$
(82,684)
|
|
$ (84,512)
|
Adjustments:
|
|
|
|
|
Pre-existing
settlement gain
|
|
(80,229)
|
|
—
|
Amortization expense
of intangible assets
|
|
3,307
|
|
—
|
Change in fair value
of contingent consideration
|
|
3,000
|
|
—
|
Adjusted Non-GAAP
Operating expenses
|
|
$
(156,606)
|
|
$ (84,512)
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/orexigen-therapeutics-reports-financial-results-for-the-fourth-quarter-and-year-ended-december-31-2016-300430699.html
SOURCE Orexigen Therapeutics, Inc.