EX-99.1 2 d172984dex991.htm EX-99.1 EX-99.1

Exhibit 99.1



Orexigen Therapeutics Reports Business and Financial Results for the Second Quarter Ended June 30, 2016

SAN DIEGO, August 4, 2016 — 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® (naltrexone HCl/bupropion HCl extended-release tablets) 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 products sales of $1.8M 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 (³5 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




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.


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.




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.


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.


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 (³18 years) with an initial Body Mass Index (BMI) of


  ³ 30 kg/m2 (obese), or


  ³ 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:


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.

Source: Orexigen Therapeutics, Inc.

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)



     Three Months Ended
June 30,
    Six Months Ended
June 30,
     2016     2015     2016     2015  



Collaborative agreement

   $ 2,403      $ 2,057      $ 4,794      $ 4,114   


     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,



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        —     


     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