SAN DIEGO, May 9, 2017 /PRNewswire/ -- Orexigen
Therapeutics, Inc. (Nasdaq: OREX) today announced business and
financial results for the first quarter ended March 31, 2017.
"During the first quarter of 2017, the team at Orexigen
delivered dramatic growth of U.S. Contrave sales and a clear trend
break from prior performance," said Mike
Narachi, CEO of Orexigen. He continued, "Our commercial
model continues to evolve, and we expect it to become increasingly
effective and more efficient, which we believe positions
Orexigen to deliver strong, sustainable growth as we advance
towards profitability. It's been an exciting start to 2017, and we
look forward to providing additional updates regarding our
performance throughout the year."
Adding to Mike's comments, Dr. Thomas
Cannell, Chief Operating Officer and President of Global
Commercial Products said, "Since the start of the year, our
patient-centric campaign has been in full swing and our sales force
has consistently been exceeding expectations. During the first
quarter of 2017, Contrave established new all-time highs for nearly
a dozen prescription volume and share metrics since the product was
launched. Our telemedicine pilot program has also demonstrated
early signs of success in California and Texas, and we're now targeting the expansion
of the offering to 47 total states by the end of May. The combined
effect of this novel, broadly-integrated commercial effort is
clearly visible in our prescription-volume and net-sales
performance to date."
First Quarter 2017 business highlights:
- Delivered strong prescription growth for Contrave® (naltrexone
HCl and bupropion HCl extended-release tablets) in the United States, achieving new all-time
highs across a broad range of key metrics including weekly total
prescription volume and market share
- Achieved 39% growth in prescriptions in the United States in Q1 2017 versus Q4
2016
- Achieved 22% growth in average net revenue per unit sold in
the United States compared to the
first quarter of 2016
- Continued with the rollout of a comprehensive digital and
social-media marketing strategy, including the launches of Contrave
Facebook® and Instagram© pages
- Initiated the expansion of the Contrave telemedicine pilot from
two states, Texas and California, to a target of 47 states by the
end of May 2017
- Executed a distribution agreement with Bruno Farmaceutici
S.p.A. for the commercialization of Mysimba in Italy
- Negotiated the recently-executed distribution arrangement with
Navamedic ASA for the commercialization of Mysimba in Denmark, Finland, Norway, Sweden and Iceland
- Worked with our partner Laboratorios Farmacéuticos Rovi to
launch Mysimba in Spain, and our
partner Valeant to launch in six additional countries in Central
and Eastern Europe
- Reduced debt by approximately $7.2
million following the completion of an exchange of our
convertible notes
Business and financial results for the three months ended
March 31, 2017
According to IMS Health, 195,920 total prescriptions of Contrave
were filled in the first quarter of 2017, as compared to 192,005
total prescriptions filled in the first quarter of 2016.
Orexigen reported first quarter 2017 revenue of $19.1 million, including $14.8 million in net sales of Contrave in the
United Sates and $4.3 million in net
sales to partners outside the United
States. In the first quarter of 2016, Orexigen reported
total revenues of $5.0 million, which
included royalties earned on approximately $13.2 million of US net sales as reported by our
former partner. The increase in net sales was primarily
attributable to growth in net revenue per unit sold in the United States and product shipments to
support launches by our partners outside the United States.
Total operating expenses for the first quarter of 2017 were
$66.8 million compared to
$28.4 million for the first quarter
of 2016. This overall increase in operating expense was due
primarily to costs related to establishing and managing sales,
marketing and distribution capabilities associated with
commercializing Contrave in the United
States, including the launch of patient-activation
strategies. Operating expenses in the first quarter of 2017 also
included $3.4 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 March 31,
2017, Orexigen reported a net loss of $69.1 million, or $4.67 per share, as compared to a net loss of
$22.3 million, or $1.54 per share, for the first quarter of
2016.
As of March 31, 2017, Orexigen had
$126.6 million in cash, restricted
cash and 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 first quarter 2017 financial results and
recent business highlights. The live call may be accessed by phone
by calling (800) 708-4540 (domestic) or (847) 619-6397
(international), participant code 44748374. 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.
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
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 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.
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, especially: 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.
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; the potential for the Company to be
profitable; the Company's strategic plans and initiatives including
the Company's plans to expand its telemedicine pilot program;
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; 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 Quarterly Report on Form 10-Q which we
intend to file with the Securities and Exchange Commission on or
about May 11, 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)
|
|
|
|
March 31,
2017
|
|
December 31,
2016
|
|
|
(Unaudited)
|
|
|
Assets
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
76,656
|
|
$
92,494
|
Accounts receivable,
net
|
|
6,277
|
|
1,102
|
Investment
securities, available-for-sale
|
|
9,985
|
|
11,499
|
Restricted cash and
investments
|
|
40,000
|
|
90,005
|
Inventory
|
|
20,663
|
|
23,193
|
Prepaid expenses and
other current assets
|
|
4,938
|
|
6,168
|
Total current
assets
|
|
158,519
|
|
224,461
|
Property and
equipment, net
|
|
927
|
|
1,044
|
Intangible
assets
|
|
74,077
|
|
76,061
|
Other long-term
assets
|
|
2,672
|
|
2,835
|
Restricted
cash
|
|
188
|
|
188
|
Total
assets
|
|
$
236,383
|
|
$
304,589
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
15,640
|
|
$
15,210
|
Accrued
expenses
|
|
32,106
|
|
30,412
|
Contingent
consideration
|
|
—
|
|
15,000
|
Deferred revenue,
current portion
|
|
1,713
|
|
4,738
|
Total current
liabilities
|
|
49,459
|
|
65,360
|
Long-term contingent
consideration
|
|
8,200
|
|
6,800
|
Long-term convertible
debt
|
|
24,701
|
|
64,279
|
Long-term convertible
debt, at fair value
|
|
152,466
|
|
101,900
|
Deferred revenue,
less current portion
|
|
6,069
|
|
5,863
|
Commitments and
contingencies
|
|
|
|
|
Series Z preferred
stock, $.001 par value, 219,994 shares issued and outstanding at
March 31, 2017 and December 31, 2016
|
|
3,343
|
|
3,343
|
Stockholders'
equity:
|
|
|
|
|
Preferred stock,
$.001 par value, 10,000,000 shares authorized at March 31, 2017 and
December 31, 2016; 219,994 shares issued and outstanding at March
31, 2017 and December 31, 2016, respectively
|
|
—
|
|
—
|
Common stock, $.001
par value, 300,000,000 shares authorized at March 31, 2017 and
December 31, 2016; 15,227,802 and 14,616,751 shares issued and
outstanding at March 31, 2017 and December 31, 2016,
respectively
|
|
15
|
|
15
|
Additional paid-in
capital
|
|
703,933
|
|
698,229
|
Accumulated other
comprehensive income
|
|
2,495
|
|
4,011
|
Accumulated
deficit
|
|
(714,298)
|
|
(645,211)
|
Total stockholders'
equity (deficit)
|
|
(7,855)
|
|
57,044
|
Total liabilities and
stockholders' equity (deficit)
|
|
$
236,383
|
|
$
304,589
|
Orexigen
Therapeutics, Inc.
|
Consolidated
Statements of Operations
|
(In thousands,
except per share amounts)
|
(Unaudited)
|
|
|
|
Three Months Ended
March 31,
|
|
|
2017
|
|
2016
|
Revenues:
|
|
|
|
|
Net product
sales
|
|
$
19,041
|
|
$
—
|
Collaborative
agreement
|
|
104
|
|
2,391
|
Royalties
|
|
—
|
|
2,642
|
Total
revenues
|
|
19,145
|
|
5,033
|
Cost of product
sales
|
|
6,187
|
|
—
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
|
8,173
|
|
11,801
|
Selling, general and
administrative
|
|
55,247
|
|
16,551
|
Amortization expense
of intangible assets
|
|
1,984
|
|
—
|
Change in fair value
of contingent consideration
|
|
1,400
|
|
—
|
Total operating
expenses
|
|
66,804
|
|
28,352
|
Loss from
operations
|
|
(53,846)
|
|
(23,319)
|
Other income
(expense):
|
|
|
|
|
Interest
income
|
|
147
|
|
123
|
Interest
expense
|
|
(1,173)
|
|
(1,936)
|
Change in fair value
of financial instruments
|
|
(28,006)
|
|
—
|
Gain on
extinguishment of debt
|
|
12,316
|
|
—
|
Foreign currency
gain, net
|
|
1,475
|
|
2,784
|
Total other income
(expense)
|
|
(15,241)
|
|
971
|
Net loss
|
|
$ (69,087)
|
|
$ (22,348)
|
Net loss per share -
basic and diluted
|
|
$
(4.67)
|
|
$
(1.54)
|
Shares used in
computing basic and diluted net loss per share
|
|
14,806
|
|
14,556
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/orexigen-therapeutics-reports-financial-results-for-the-first-quarter-ended-march-31-2017-300454637.html
SOURCE Orexigen Therapeutics, Inc.