SAN DIEGO, Nov. 13, 2017 /PRNewswire/ -- Orexigen
Therapeutics, Inc. (Nasdaq: OREX) today announced business and
financial results for the third quarter ended September 30, 2017.
Orexigen Therapeutics Recent Business Highlights:
- Drove 26% increase in Contrave® (naltrexone HCl / bupropion HCl
extended release) total prescription volume in the United States in the third quarter of 2017
relative to the third quarter of 2016
- Received positive U.S District Court ruling regarding its
patent litigation with Actavis, providing market exclusivity for
Contrave into 2030
- Launched successful fall advertising campaign which, for the
first time, featured active promotion of the "Get Contrave Now"
website and the innovative telemedicine platform supporting the
prescribing of Contrave through online or telephone-based physician
consultations, with free-home delivery
- Finalized commercialization and distributorship agreement with
Merck KGaA, Darmstadt, Germany for
Latin America, including
Brazil and Mexico; Contrave/Mysimba™ is now partnered in
67 markets and launched in 17 countries, with 10-15 additional
international launches expected by the end of the first quarter of
2018
"Our performance in the third quarter of 2017 reflects the
continued success of the commercial strategy we launched late last
year. The dramatic results generated by the launch of the next
phase of our patient-activation campaign in September supports our
thesis that we can drive significant growth in Contrave sales but
at a substantially lower cost than that of a more-traditional
primary care selling model," said Mike
Narachi, President and Chief Executive Officer of
Orexigen. Mike continued, "Adding to our continued, strong
year-over-year business performance, the recently-announced
positive decision from the U.S. District Court regarding our patent
litigation with Actavis has solidified our intellectual property
portfolio and provides Contrave with market exclusivity into 2030.
This broad window of market exclusivity, coupled with growing
global Contrave/Mysimba sales, positions Orexigen for over a decade
of profitable growth beginning in 2019, the year in which we have
previously guided that we expect to achieve profitability."
Business and financial results for the three
months ended September 30,
2017
According to data compiled by IMS Health and telemedicine
partners working with Orexigen, 208,397 total prescriptions of
Contrave were filled in the third quarter of 2017, as compared to
164,746 total prescriptions filled in the third quarter of
2016.
Orexigen reported third quarter 2017 revenue of $18.9 million, including $17.8 million in net sales of Contrave in
the United States, and
$1.1 million in combined net sales to
partners outside the United States
and milestone income. In the third quarter of 2016, Orexigen
recorded total revenue of $7.0
million, including $1.8
million of combined collaborative income and royalties
earned on U.S. net sales of Contrave generated by our former
partner in July 2016 prior to the
completed acquisition of Contrave by Orexigen and $5.2 million of U.S. net sales of Contrave
generated by Orexigen in August and September 2016 following the completed
acquisition. The combined total net sales of Contrave
in the United States during the
third quarter of 2016, as reported by Orexigen and our former
partner were $9.6 million.
Total operating expenses for the third quarter of 2017 were
$37.6 million compared to a credit of
$37.5 million for the third quarter
of 2016. Third quarter 2016 operating expense was impacted by
a non-cash settlement gain of $80.2
million resulting from the elimination of
previously-recorded pre-existing deferred revenue.
For the three months ended September 30,
2017, Orexigen reported a net loss of $20.8 million, or $1.35 per share.
As of September 30, 2017, Orexigen
had $70.6 million in cash, cash
equivalents and marketable securities.
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 third quarter 2017 financial results and
recent business highlights. The live call may be accessed by
phone by (800) 708-4539 (domestic) or (847) 619-6396
(international), participant code 45886353. The webcast can
be accessed live on the Investors section of the Orexigen web site
at www.orexigen.com, and will be archived for 14 days following the
call.
About Contrave and Mysimba
Contrave, marketed as Mysimba in the European Union, is a
prescription-only, FDA-approved weight-loss medication believed to
work on two areas of the brain—the hunger center and the reward
system—to reduce hunger and help control cravings. The exact
neurochemical effects of Contrave/Mysimba leading to weight loss
are not fully understood. Contrave/Mysimba contains two
medicines, bupropion, a relatively weak inhibitor of the neuronal
reuptake of dopamine and norepinephrine and naltrexone, an opioid
antagonist.
Contrave, approved by the FDA 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, Mysimba was approved in
March 2015.
Orexigen is committed to helping eligible patients learn about
Contrave and recommends patients in the U.S. visit www.contrave.com
for additional information.
For full U.S. prescribing information please visit
www.contrave.com.
Important Safety Information for CONTRAVE and MYSIMBA (per
U.S. prescribing information)
(naltrexone HCl and bupropion HCl) 8 mg/90 mg
extended-release tablets
One of the ingredients in CONTRAVE, bupropion, may increase
the risk of suicidal thinking in children, adolescents, and young
adults. CONTRAVE patients should be monitored for suicidal
thoughts and behaviors. In patients taking bupropion
for smoking cessation, serious neuropsychiatric adverse events have
been reported. CONTRAVE is not approved for use in children
under the age of 18.
Stop taking CONTRAVE and call a healthcare provider right
away if you have any of the following symptoms, especially if they
are new, worse, or worry you: thoughts about suicide or dying;
attempts to commit suicide; depression; anxiety; feeling agitated
or restless; panic attacks; trouble sleeping (insomnia);
irritability; aggression, anger, or violence; acting on dangerous
impulses; an extreme increase in activity and talking (mania);
other unusual changes in behavior or mood.
Do not take CONTRAVE if you have uncontrolled high blood
pressure; have or have had seizures; use other medicines that
contain bupropion such as WELLBUTRIN, APLENZIN or ZYBAN; have or
have had an eating disorder; are dependent on opioid pain medicines
or use medicines to help stop taking opioids such as methadone or
buprenorphine, or are in opiate withdrawal; drink a lot of alcohol
and abruptly stop drinking; are allergic to any of the ingredients
in CONTRAVE; or are pregnant or planning to become pregnant.
Before taking CONTRAVE, tell your healthcare provider about
all the medicines you take, including prescription and
over-the-counter medicines, vitamins, and herbal supplements.
Do not take any other medicines while you are taking CONTRAVE
unless your healthcare provider says it is okay.
Tell your healthcare provider about all of your medical
conditions including if you have: depression or other mental
illnesses; attempted suicide; seizures; head injury; tumor or
infection of brain or spine; low blood sugar or low sodium; liver
or kidney problems; high blood pressure; heart attack, heart
problems, or stroke; eating disorder; drinking a lot of alcohol;
prescription medicine or street drug abuse; are 65 or older;
diabetes; pregnant; or breastfeeding.
CONTRAVE may cause serious side effects, including:
Seizures. There is a risk of having a seizure when
you take CONTRAVE. If you have a seizure, stop taking
CONTRAVE, tell your healthcare provider right
away.
Risk of opioid overdose. Do not take large amounts
of opioids, including opioid-containing medicines, such as heroin
or prescription pain pills, to try to overcome the opioid-blocking
effects of naltrexone.
Sudden opioid withdrawal. Do not use any type of
opioid for at least 7 to 10 days before starting
CONTRAVE.
Severe allergic reactions. Stop taking CONTRAVE and
get medical help immediately if you have any signs and symptoms of
severe allergic reactions: rash, itching, hives, fever, swollen
lymph glands, painful sores in your mouth or around your eyes,
swelling of your lips or tongue, chest pain, or
trouble breathing.
Increases in blood pressure or heart rate.
Liver damage or hepatitis. Stop taking CONTRAVE if
you have any symptoms of liver problems: stomach area pain lasting
more than a few days, dark urine, yellowing of the whites of your
eyes, or tiredness.
Manic episodes.
Visual problems (angle-closure glaucoma). Signs and
symptoms may include: eye pain, changes in vision, swelling or
redness in or around the eye.
Increased risk of low blood sugar (hypoglycemia) in people
with type 2 diabetes mellitus who also take medicines to treat
their diabetes (such as insulin or sulfonylureas).
The most common side effects of CONTRAVE include nausea,
constipation, headache, vomiting, dizziness, trouble sleeping, dry
mouth, and diarrhea.
These are not all the possible side effects of CONTRAVE. Tell
your healthcare provider about any side effect that bothers you or
does not go away.
Use of CONTRAVE
CONTRAVE is a prescription weight-loss medicine that may help
some adults with a body mass index (BMI) of
30 kg/m2 or greater (obese), or adults with a BMI
of 27 kg/m2 or greater (overweight) with at least
one weight-related medical problem such as high blood pressure,
high cholesterol, or type 2 diabetes, lose weight and keep the
weight off.
- CONTRAVE should be used with a reduced-calorie diet and
increased physical activity
- It is not known if CONTRAVE changes your risk of heart problems
or stroke or of death due to heart problems or stroke
- It is not known if CONTRAVE is safe and effective when taken
with other prescription, over-the-counter, or herbal weight-loss
products
CONTRAVE is not approved to treat depression or other mental
illnesses, or to help people quit smoking (smoking
cessation). One of the ingredients in CONTRAVE, bupropion, is
the same ingredient in some other medicines used to treat
depression and to help people quit smoking.
Ask your doctor or healthcare professional if CONTRAVE is
right for you. Please see Full Prescribing
Information, including 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.
About Obesity & Weight Loss
Obesity is a serious and rising health epidemic and has been
declared a disease by the American Medical Association. It is
estimated that about 110 million adults are overweight or
struggling with obesity; however, only 3% are treated with a
prescription weight loss medicine. By 2030, the percentage of
Americans who struggle with obesity could reach 51%. Obesity
can increase the risk of heart disease, type 2 diabetes, some types
of cancer, sleep apnea, and a variety of other conditions.
Weight loss is complex and for many people diet and exercise alone
may not be enough. Two areas of the brain play an important
role in weight loss. The hypothalamus, your hunger center,
regulates hunger and the mesolimbic reward system can cause
cravings even when you are not hungry. Other areas of the
brain may be involved.
About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company
focused on the treatment of weight loss and obesity. Our
mission is to help improve the health and lives of patients
struggling to lose weight. Orexigen's first product,
Contrave® (naltrexone HCl and bupropion HCl extended release), was
approved in the U.S. in September
2014 and became the #1 prescription weight loss brand in the
U.S. in June 2015. In the European Union, the medicine has
been approved under the brand name Mysimba™ (naltrexone HCl/
bupropion HCl prolonged release). Millions around the globe
continue to face challenges of weight loss. 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. As a
patient-centric company, we continue to focus not only on
innovating medicine for the treatment of obesity, but to also offer
unique resources and healthcare delivery options to improve the
patient experience. 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; expectations
regarding Orexigen's future profitability; and the potential growth
of Contrave/Mysimba sales.
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; the company's ability
to obtain and maintain partnerships and the ability of it or its
partners to maintain marketing authorization globally; the
company's ability to adequately inform consumers about Contrave;
the company's ability to successfully commercialize Contrave with a
specialty sales force in the United
States; the capabilities and performance of various third
parties on which it relies for a number of activities related to
the manufacture, development and commercialization of
Contrave/Mysimba; the estimates of the capacity of manufacturing
and the company's ability to secure additional manufacturing
capabilities; the company's ability to successfully complete the
post-marketing requirement studies for Contrave; the therapeutic
and commercial value of Contrave/Mysimba; competition in the global
obesity market, particularly from existing therapies; the company's
failure to successfully acquire, develop and market additional
product candidates or approved products; the company's ability to
obtain and maintain global intellectual property protection for
Contrave and Mysimba; the potential for an appeals court to
determine in our patent litigation matter with Actavis that one or
more of the company's patents is not valid or that Actavis'
proposed generic product is not infringing each of the patents at
issue; other legal or regulatory proceedings against Orexigen, as
well as potential reputational harm, as a result of misleading
public claims about Orexigen; the company's ability to maintain
sufficient capital to fund its operations for the foreseeable
future; the company's ability to satisfy covenants in the
indentures for its outstanding indebtedness, including one
requirement that the company generate consolidated net product
sales of least $100 million for
fiscal year 2017; the company's ability to satisfy the applicable
listing standards of the NASDAQ Global Market; 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 Quarterly
Report on Form 10-Q which we intend to file with the Securities and
Exchange Commission on or about November 13,
2017 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 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)
|
|
|
|
September 30,
2017
|
|
December 31,
2016
|
|
|
(Unaudited)
|
|
(See Note
below)
|
Assets
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
45,577
|
|
$
92,494
|
Accounts receivable,
net
|
|
19,103
|
|
1,102
|
Investment
securities, available-for-sale
|
|
24,990
|
|
11,499
|
Restricted cash and
investments
|
|
—
|
|
90,005
|
Inventory
|
|
16,105
|
|
23,193
|
Prepaid expenses and
other current assets
|
|
6,510
|
|
6,168
|
Total current
assets
|
|
112,285
|
|
224,461
|
Property and
equipment, net
|
|
702
|
|
1,044
|
Intangible
assets
|
|
70,108
|
|
76,061
|
Other long-term
assets
|
|
464
|
|
2,835
|
Restricted
cash
|
|
188
|
|
188
|
Total
assets
|
|
$
183,747
|
|
$
304,589
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
10,933
|
|
$
15,210
|
Accrued
expenses
|
|
44,061
|
|
30,412
|
Contingent
consideration
|
|
—
|
|
15,000
|
Deferred revenue,
current portion
|
|
1,238
|
|
4,738
|
Total current
liabilities
|
|
56,232
|
|
65,360
|
Long-term contingent
consideration
|
|
8,400
|
|
6,800
|
Long-term convertible
debt
|
|
25,367
|
|
64,279
|
Long-term convertible
debt, at fair value
|
|
146,234
|
|
101,900
|
Deferred revenue,
less current portion
|
|
6,538
|
|
5,863
|
Commitments and
contingencies
|
|
|
|
|
Series Z preferred
stock, $0.001 par value, 219,994 shares issued and outstanding at
September 30, 2017 and December 31, 2016
|
|
3,343
|
|
3,343
|
Stockholders'
equity:
|
|
|
|
|
Preferred stock,
$0.001 par value, 10,000,000 shares authorized at September
30, 2017 and December 31, 2016; 219,994 shares issued and
outstanding at September 30, 2017 and December 31, 2016,
respectively
|
|
—
|
|
—
|
Common stock, $0.001
par value, 300,000,000 shares authorized at September 30,
2017 and December 31, 2016; 15,601,157 and 14,616,751 shares
issued and outstanding at September 30, 2017 and December 31, 2016,
respectively
|
|
16
|
|
15
|
Additional paid-in
capital
|
|
710,607
|
|
698,229
|
Accumulated other
comprehensive income (loss)
|
|
(7,345)
|
|
4,011
|
Accumulated
deficit
|
|
(765,645)
|
|
(645,211)
|
Total stockholders'
equity (deficit)
|
|
(62,367)
|
|
57,044
|
Total liabilities and
stockholders' equity
|
|
$
183,747
|
|
$
304,589
|
|
|
|
|
|
|
Note: The Balance
Sheet at December 31, 2016 has been derived from the audited
financial statements at that date.
|
Orexigen
Therapeutics, Inc.
|
Consolidated
Statements of Operations
|
(In thousands,
except per share amounts)
|
(Unaudited)
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
Revenues:
|
|
|
|
|
|
|
|
|
Net product
sales
|
|
$
18,768
|
|
$
5,241
|
|
$
61,041
|
|
$
8,176
|
Collaborative
agreement
|
|
135
|
|
895
|
|
363
|
|
5,689
|
Royalties
|
|
—
|
|
866
|
|
—
|
|
5,961
|
Total
revenues
|
|
18,903
|
|
7,002
|
|
61,404
|
|
19,826
|
Cost of product
sales
|
|
4,037
|
|
1,940
|
|
17,066
|
|
3,724
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
5,776
|
|
5,254
|
|
21,458
|
|
31,304
|
Selling, general and
administrative
|
|
30,367
|
|
35,103
|
|
133,925
|
|
76,645
|
Pre-existing
settlement gain
|
|
—
|
|
(80,229)
|
|
—
|
|
(80,229)
|
Amortization expense
of intangible assets
|
|
1,985
|
|
1,408
|
|
5,953
|
|
1,408
|
Change in fair value
of contingent consideration
|
|
(500)
|
|
1,000
|
|
1,600
|
|
1,000
|
Total operating
expenses
|
|
37,628
|
|
(37,464)
|
|
162,936
|
|
30,128
|
Income (loss) from
operations
|
|
(22,762)
|
|
42,526
|
|
(118,598)
|
|
(14,026)
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Interest
income
|
|
180
|
|
239
|
|
444
|
|
525
|
Interest
expense
|
|
(794)
|
|
(1,988)
|
|
(2,830)
|
|
(5,878)
|
Change in fair value
of financial instruments
|
|
(628)
|
|
6,100
|
|
(22,668)
|
|
17,700
|
Gain on
extinguishment of debt
|
|
—
|
|
—
|
|
12,316
|
|
—
|
Foreign currency gain
(loss), net
|
|
3,175
|
|
786
|
|
10,902
|
|
1,764
|
Total other income
(expense)
|
|
1,933
|
|
5,137
|
|
(1,836)
|
|
14,111
|
Net income (loss) -
basic
|
|
$
(20,829)
|
|
$
47,663
|
|
$
(120,434)
|
|
$
85
|
Net income (loss) -
diluted
|
|
$
(20,829)
|
|
$
40,963
|
|
$
(120,434)
|
|
$
85
|
Basic net income
(loss) per share
|
|
$
(1.35)
|
|
$
3.27
|
|
$
(7.94)
|
|
$
0.01
|
Diluted net income
(loss) per share
|
|
$
(1.35)
|
|
$
1.12
|
|
$
(7.94)
|
|
$
0.01
|
Basic shares used in
computing net income (loss) per share
|
|
15,440
|
|
14,587
|
|
15,164
|
|
14,570
|
Diluted shares used
in computing net income (loss) per share
|
|
15,440
|
|
36,615
|
|
15,164
|
|
14,570
|
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SOURCE Orexigen Therapeutics, Inc.