Form 8-K Orexigen Therapeutics, For: Nov 05
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 5, 2015
OREXIGEN THERAPEUTICS, INC.
(Exact Name of Registrant as Specified in its Charter)
| Delaware | 001-33415 | 65-1178822 | ||
| (State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
| 3344 N. Torrey Pines Ct., Suite 200, La Jolla, CA | 92037 | |
| (Address of Principal Executive Offices) | (Zip Code) |
Registrant’s telephone number, including area code: (858) 875-8600
(Former Name or Former Address, if Changed Since Last Report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 2.02 | Results of Operations and Financial Condition |
On November 5, 2015, Orexigen Therapeutics, Inc. (the “Company” or “Orexigen”) issued a press release announcing its financial results for the three months ended September 30, 2015. A copy of this press release is attached hereto as Exhibit 99.1.
| Item 7.01. | Regulation FD Disclosure. |
Starting on November 5, 2015, representatives of the Company will be presenting to and conducting meetings with investors, analysts and others. During these presentations and meetings, the Company will present the slides attached as Exhibit 99.2 to this Current Report on Form 8-K, which is incorporated herein by reference.
The information in Items 2.02 and 7.01 of this Current Report on Form 8-K, including Exhibits 99.1 and 99.2, is being furnished pursuant to Items 2.02 and 7.01 and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to the items of this report.
* * *
By filing this Current Report on Form 8-K and furnishing this information, the Company makes no admission as to the materiality of any information in this report. The information contained in this report is intended to be considered in the context of the Company’s filings with the Securities and Exchange Commission (“SEC”) and other public announcements that the Company makes, by press release or otherwise, from time to time. The Company undertakes no duty or obligation to publicly update or revise the information contained in this report, although it may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosure.
Orexigen cautions you that statements included in this report 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 for Contrave and Mysimba to achieve commercial success globally; the potential to continue a successful launch in the United States; the potential to commercialize in the European Union in 2016; the potential for the acquisition of new assets; the potential success of Orexigen’s go to market approach outside of the United States; Orexigen’s ability to retain ownership of Contrave/Mysimba in certain markets; the potential for significant sales for Contrave/Mysimba outside of the United States; the projections for overall obesity prescription market growth; the potential unmet need and market opportunity in United States and Europe; the potential for Orexigen to obtain marketing authorizations or commercialization partner(s) for Contrave in territories outside the United States and South Korea; the sufficiency of Orexigen’s cash resources; anticipated trends in our business and industry; the potential to maintain and strengthen the intellectual property protection for Contrave/Mysimba globally and other characterizations of future events or circumstances. 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 cardiovascular outcomes trial 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 dependence on Takeda to continue the commercial launch of Contrave in 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; the potential for early termination of our collaboration agreement with Takeda; 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 reliance on Takeda 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 report 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 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission August 8, 2015 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 “Investor Relations.” 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.
| Item 9.01 | Financial Statements and Exhibits |
(d) Exhibits.
| Exhibit No. |
Description | |
| 99.1 | Press Release, dated November 5, 2015 | |
| 99.2 | Slide Presentation, dated November 5, 2015 | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| OREXIGEN THERAPEUTICS, INC. | ||||||
| Date: November 5, 2015 | By: | /s/ Joseph P. Hagan | ||||
| Name: | Joseph P. Hagan | |||||
| Title: | EVP, Chief Business and Financial Officer | |||||
Exhibit 99.1
Orexigen Therapeutics Reports Financial and Business Results for the Third Quarter Ended September 30, 2015
| • | More than 500,000 prescriptions written in first full year of Contrave® (naltrexone HCI and bupropion HCI extended-release tablets) launch |
San Diego, CA, November 5, 2015 – Orexigen Therapeutics, Inc. (Nasdaq: OREX) today announced business and financial results for the third quarter ended September 30, 2015.
“In the first 12 months since the U.S. launch, we have been encouraged by gross demand for Contrave, with well over 500,000 prescriptions written by approximately 50,000 physicians,” said Mike Narachi, CEO of Orexigen. “In the coming year, we expect the overall market for anti-obesity medicines to grow significantly year over year and for Contrave to continue to gain overall market share.”
Recent Business Highlights:
| • | According to IMS Health, 190,201 prescriptions of Contrave® (naltrexone HCl and bupropion HCl extended-release tablets) were filled in the third quarter 2015, an increase of 10% compared to the second quarter. |
| • | Kwang Dong Pharmaceutical Company, Ltd., has filed a New Drug Application with the Ministry of Food and Drug Safety (MFDS) in South Korea for Contrave® (naltrexone HCl and bupropion HCl) as a monotherapy for weight management in overweight or obese adult patients. If approved, Kwang Dong will market and distribute Contrave as part of its distributorship agreement with Orexigen’s wholly-owned subsidiary Orexigen Therapeutics Ireland Ltd., executed in August 2015. Under the terms of the agreement, Kwang Dong is responsible for seeking regulatory approval and for all commercialization activity and expenses. Kwang Dong expects to begin marketing Contrave in the second half of 2016, pending regulatory approval. In September, Orexigen received a $7 million upfront payment from Kwang Dong. |
| • | In September, Orexigen received the first of three potential $15 million anniversary milestone payments from Takeda Pharmaceuticals, Orexigen’s United States partner for Contrave. Two additional potential $15 million anniversary milestone payments are expected from Takeda in the fourth quarter of each of 2016 and 2017. |
Financial results for the three months ended September 30, 2015
For the three months ended September 30, 2015, Orexigen reported a net loss of $11.1 million, or $0.09 per share, as compared to a profit of $11.3 million, or $0.09 per share, for the third quarter of 2014.
Orexigen reported third quarter revenue of $10 million, including $2.6 million in royalties earned on U.S. net sales of Contrave of $12.8 million recorded by Orexigen’s partner for North America, Takeda Pharmaceuticals.
Total operating expenses for the third quarter of 2015 were $20.9 million compared to $17.8 million for the third quarter of 2014. The increase in operating expense was driven by an increase in general and administrative expense, primarily for marketing and consulting costs, partially offset by a decline in clinical development costs.
As of September 30, 2015, Orexigen had $154.3 million in cash and cash equivalents and an additional $79.2 million in marketable securities, for a total of $233.4 million.
Conference Call Today at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time)
The Orexigen management team will host a teleconference and webcast to discuss the third quarter 2015 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 41044938. 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 Europe, the medicine was approved in March 2015 with the brand name Mysimba.
The exact neurochemical effects of Contrave leading to weight loss are not fully understood. Contrave has two components: naltrexone, an opioid antagonist, and bupropion, a relatively weak inhibitor of the neuronal reuptake of dopamine and norepinephrine. Nonclinical studies suggest that naltrexone and bupropion have effects on two separate areas of the brain involved in the regulation of food intake: the hypothalamus (appetite regulatory center) and the mesolimbic dopamine circuit (reward system).
Four 56-week multicenter, double-blind, placebo-controlled Phase 3 clinical trials were conducted to evaluate the effect of Contrave in conjunction with lifestyle modification in 4,536 subjects randomized to Contrave or placebo. In these studies, the most common adverse reactions (>5 percent) seen in patients taking Contrave included nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea.
The clinical trial program also includes a double-blind, placebo-controlled cardiovascular outcomes trial known as the Light Study. The primary objective of this study was to evaluate the occurrence of major adverse cardiovascular events (MACE) in overweight and obese adults with cardiovascular risk factors receiving Contrave. A second study, designed to address post-approval requirements in both Europe and the United States, is planned in order to further evaluate cardiovascular outcomes.
Further information can be found at http://www.orexigen.com/.
Important Safety Information for CONTRAVE and MYSIMBA
(naltrexone HCl and bupropion HCl) 8 mg/90 mg extended-release tablets
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS; AND NEUROPSYCHIATRIC REACTIONS
Suicidality and Antidepressant Drugs
Not approved for use in the treatment of major depressive disorder or other psychiatric disorders. Contains bupropion, the same active ingredient as some other antidepressant medications (including, but not limited to, WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, and APLENZIN). Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects over age 24; there was a reduction in risk with antidepressant use in subjects aged 65 and older. In patients of all ages, monitor closely for worsening, and for the emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber. Not approved for use in pediatric patients.
Neuropsychiatric Reactions in Patients Taking Bupropion for Smoking Cessation
Serious neuropsychiatric reactions have occurred in patients taking bupropion for smoking cessation. The majority of these reactions occurred during bupropion treatment, but some occurred in the context of discontinuing treatment. In many
cases, a causal relationship to bupropion treatment is not certain, because depressed mood may be a symptom of nicotine withdrawal. However, some of the cases occurred in patients taking bupropion who continued to smoke. Although not approved for smoking cessation, observe all patients for neuropsychiatric reactions. Instruct the patient to contact a healthcare provider if such reactions occur.
Contraindications
Contraindicated in: uncontrolled hypertension; seizure disorder or a history of seizures; use of other bupropion-containing products; bulimia or anorexia nervosa, which increase the risk for seizure; chronic opioid or opiate agonist (eg, methadone) or partial agonists (eg, 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 (eg, 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 (ie, 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 (eg, 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 (eg, 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 (eg, 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 (eg, 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 comorbid condition (eg, hypertension, type 2 diabetes mellitus, or dyslipidemia) or greater (overweight) in the presence of at least one weight-related comorbid condition (eg, 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 (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: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003687/human_med_001845.jsp&mid=WC0b01ac058001d124
Mysimba™ and Contrave ® are trademarks of Orexigen Therapeutics, Inc. registered with the U.S. Patent and Trademark Office.
About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. Orexigen developed Contrave® (naltrexone HCl and bupropion HCl extended release), which is approved in the United States and is being commercialized there by the company’s U.S. partner, Takeda Pharmaceuticals. In Europe the drug has been approved under the brand name MysimbaTM (naltrexone HCl/ bupropion HCl prolonged release). Orexigen’s strategy for Contrave/Mysimba is to pursue marketing authorizations worldwide and pharmaceutical partnerships for global commercialization. Further information about the Company can be found at http://www.orexigen.com/.
Forward-Looking Statements
Orexigen cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “should,” “intends,” “potential,” “suggests,” “assuming,” “designed” and similar expressions are intended to identify forward-looking statements. These statements are based on the Company’s current beliefs and expectations. These forward-looking statements include statements regarding: the potential success of marketing and commercialization of Contrave/Mysimba; the potential for the overall market for anti-obesity medicines to grow significantly year over year and for Contrave to continue to gain overall market share; and the potential for and timing of regulatory approval and commercialization of Contrave in South Korea. 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 dependence on Takeda to carry out the commercial launch of Contrave in 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; the potential for early termination of our collaboration agreement with Takeda; 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 reliance on Takeda 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 Quarterly Report on Form 10-Q we filed with the Securities and Exchange Commission on or about August 7, 2015 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.
Balance Sheets
(In thousands, except share and par value amounts)
| September 30, 2015 |
December 31, 2014 |
|||||||
| (Unaudited) | ||||||||
| Assets |
||||||||
| Current assets: |
||||||||
| Cash and cash equivalents |
$ | 154,267 | $ | 104,243 | ||||
| Accounts receivable |
4,560 | 2,571 | ||||||
| Investment securities, available-for-sale |
79,175 | 101,294 | ||||||
| Inventory |
11,068 | 1,198 | ||||||
| Deferred tax assets |
547 | 547 | ||||||
| Prepaid expenses and other current assets |
2,231 | 1,473 | ||||||
|
|
|
|
|
|||||
| Total current assets |
251,848 | 211,326 | ||||||
| Property and equipment, net |
931 | 857 | ||||||
| Other long-term assets |
1,415 | 621 | ||||||
| Restricted cash |
138 | 177 | ||||||
|
|
|
|
|
|||||
| Total assets |
$ | 254,332 | $ | 212,981 | ||||
|
|
|
|
|
|||||
| Liabilities and stockholders’ equity |
||||||||
| Current liabilities: |
||||||||
| Accounts payable |
$ | 3,917 | $ | 4,243 | ||||
| Accrued clinical trial expenses |
8,806 | 10,690 | ||||||
| Accrued expenses |
12,720 | 6,552 | ||||||
| Deferred revenue, current portion |
10,004 | 8,229 | ||||||
|
|
|
|
|
|||||
| Total current liabilities |
35,447 | 29,714 | ||||||
| Long-term convertible debt |
87,043 | 83,908 | ||||||
| Deferred revenue, less current portion |
84,849 | 76,114 | ||||||
| Deferred tax liabilities |
547 | 547 | ||||||
| Other long-term liabilities |
206 | 354 | ||||||
| Commitments and contingencies |
||||||||
| Stockholders’ equity: |
||||||||
| Preferred stock, $.001 par value, 10,000,000 shares authorized at September 30, 2015 and December 31, 2014; no shares issued and outstanding at September 30, 2015 and December 31, 2014 |
— | — | ||||||
| Common stock, $.001 par value, 300,000,000 shares authorized at September 30, 2015 and December 31, 2014; 145,414,090 and 123,460,598 shares issued and outstanding at September 30, 2015 and December 31, 2014, respectively |
145 | 123 | ||||||
| Additional paid-in capital |
650,612 | 574,247 | ||||||
| Accumulated other comprehensive income (loss) |
(1,639 | ) | (26 | ) | ||||
| Accumulated deficit |
(602,878 | ) | (552,000 | ) | ||||
|
|
|
|
|
|||||
| Total stockholders’ equity |
46,240 | 22,344 | ||||||
|
|
|
|
|
|||||
| Total liabilities and stockholders’ equity |
$ | 254,332 | $ | 212,981 | ||||
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Orexigen Therapeutics, Inc.
Statements of Operations
(In thousands, except per share amounts)
(Unaudited)
| Three Months Ended September 30, |
Nine Months Ended September 30, |
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| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| Revenues: |
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| Collaborative agreement |
$ | 7,411 | $ | 30,857 | $ | 11,525 | $ | 32,571 | ||||||||
| Royalties |
2,563 | — | 8,002 | — | ||||||||||||
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| Total revenues |
9,974 | 30,857 | 19,527 | 32,571 | ||||||||||||
| Operating expenses: |
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| Research and development |
8,817 | 10,719 | 35,166 | 44,446 | ||||||||||||
| General and administrative |
12,103 | 7,097 | 31,502 | 21,040 | ||||||||||||
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| Total operating expenses |
20,920 | 17,816 | 66,668 | 65,486 | ||||||||||||
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| Income (loss) from operations |
(10,946 | ) | 13,041 | (47,141 | ) | (32,915 | ) | |||||||||
| Other income (expense): |
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| Interest income |
65 | 16 | 195 | 68 | ||||||||||||
| Interest expense |
(1,872 | ) | (1,784 | ) | (5,544 | ) | (5,285 | ) | ||||||||
| Foreign currency gain (loss) net |
1,612 | — | 1,612 | — | ||||||||||||
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| Total other expense |
(195 | ) | (1,768 | ) | (3,737 | ) | (5,217 | ) | ||||||||
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| Net income (loss) |
$ | (11,141 | ) | $ | 11,273 | $ | (50,878 | ) | $ | (38,132 | ) | |||||
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| Basic and diluted net income (loss) per share |
$ | (0.09 | ) | $ | 0.09 | $ | (0.40 | ) | $ | (0.33 | ) | |||||
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| Shares used in computing basic net income (loss) per share |
129,747 | 122,583 | 126,295 | 116,655 | ||||||||||||
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| Shares used in computing diluted net income (loss) per share |
129,747 | 130,140 | 126,295 | 116,655 | ||||||||||||
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3Q 2015 Conference Call November 5, 2015 Exhibit 99.2
Forward Looking Statements This presentation contains forward-looking statements about Orexigen Therapeutics, Inc. and its recently approved product, Contrave. 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 for Contrave and Mysimba to achieve commercial success globally; the potential to continue a successful launch in the United States, the potential to commercialize in the European Union in 2016; the potential for the acquisition of new assets; the potential success of Orexigen’s go to market approach outside of the United States; Orexigen’s ability to retain ownership of Contrave/Mysimba in certain markets; the potential for significant sales for Contrave/Mysimba outside of the United States; the projections for overall obesity prescription market growth; the potential unmet need and market opportunity in United States and Europe; the potential for additional regulatory filings and approvals through 2016; the potential for Orexigen to obtain marketing authorizations or commercialization partner(s) for Contrave in territories outside the United States and South Korea; the sufficiency of Orexigen’s cash resources; anticipated trends in our business and industry; the potential to maintain and strengthen the intellectual property protection for Contrave/Mysimba globally and other characterizations of future events or circumstances. 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 dependence on Takeda to carry out the commercial launch of Contrave in 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; the potential for early termination of our collaboration agreement with Takeda; 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 reliance on Takeda 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 Current Report on Form 10-Q filed with the Securities and Exchange Commission on August 7, 2015 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. For investor purposes only – not for use in product promotion
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. Approved with the brand name Contrave in the United States and Mysimba in the European Union. 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. Full Prescribing Information, including Medication Guide, for Contrave is available at http://www.contrave.com/. The Mysimba Summary of Product Characteristics is available at ema.europe.eu. For investor purposes only – not for use in product promotion
2H 2015 Focus for Orexigen EU and ROW commercialization Continuing US launch success For investor purposes only – not for use in product promotion Acquisition of new assets
Successful US Contrave® (naltrexone HCl / bupropion HCl extended-release) launch, branded market share leader EU Approval for Mysimba™ (naltrexone HCl / bupropion HCl prolonged-release) Balance sheet strengthened $233 million in cash at September 30, 2015 (unaudited) Began earning royalties on US sales Established Orexigen Ireland to manage ex-US business Partnering process yielded first deal in South Korea Orexigen: An eventful 2015 For investor purposes only – not for use in product promotion
A structured process is advancing toward the best go to market approach Fully partner out License, but retain key commercial rights Launch via strategic alliances Build de novo South Korea USA EU 31 Australia Brazil Canada China India MENA Mexico Russia Launch Examples Tier 1 markets
Country 2014 Sales (M) Peak Year Sales (Year) Mexico $140 $213 (2008) Brazil $120 $164 (2008) Russia $67 $84 (2012) Korea $58 $79 (2008) Australia $56 $58 (2012) MENA* $34 $40 (2010) Canada $14 $36 (2006) India $10 $15 (2010) Significant ex-US Sales Potential for Contrave® / Mysimba™ For investor purposes only – not for use in product promotion Obesity Drug Sales in Key RoW Countries *Egypt, Saudi Arabia, Lebanon, Jordan, Kuwait, UAE and Morocco Source: IMS Health Midas 2006-2014, Includes Rx and OTC ATC3 A8A Obesity Ex-US Historic Obesity Rx Sales in 2007 ~ $1.4 billion Europe 35% ROW 65% Source: IMS Health Orexigen owns all rights outside United States and Korea for Contrave / Mysimba 7
U.S. Market
The overall US obesity prescription drug market shows solid growth Monthly TRx Source: IMS Health NPA Monthly. Note: Orlistat and other medicines not included (c. 7% of market) 1. Includes Qsymia®, Belviq®, Contrave® and Saxenda®’ Branded drugs1 Phentermine 9
The overall US obesity prescription drug market is growing with seasonal patterns of utilization +10% 2014 vs 2013 Monthly TRx Source: IMS Health NPA Monthly and Analytics Link +2% 2013 vs 2012 2015 2014 2013 +13% Sep YTD 2015 vs Sep YTD 2014 10
Contrave® continues to widen its lead in the US branded market TRx Share Source: IMS Health NPA Monthly Contrave Belviq Qsymia Saxenda 25.0% 27.3% 30.1% 32.4% 33.4% 34.8% 36.2% 37.2% 31,765 36,387 49,047 54,477 56,497 61,076 64,459 63,034 Brand TRx share TRx volume for Contrave 37.8% 62,708 Jan-15 Feb-15 Mar-15 Apr-15 May-15 Jun-15 Jul-15 Aug-15 Sep-15 11
New writers of Contrave® have increased steadily Cumulative writers Source: IMS Health Exponent Weekly, Cumulative totals for each month represented by data from the first week of the newest month. 12
Projections for overall obesity Rx market growth Source: IMS NPA Monthly; Orexigen estimates TRx (000) 2013 2014 2017 2016 2015 2018 13
EU Market
Three overarching goals guide European Strategy Realize maximum value for Orexigen's shareholders 1 Maximize market penetration and Mysimba sales 2 Deploy Orexigen's resources efficiently and effectively 3 Maintain strategic flexibility 15
EU market attributes Concentrated obesity specialist community Excess capacity of existing Pharma SFs Patient willingness to pay out-of-pocket Competitive profile of obesity Rx market Skills and capabilities of potential partners Attractive EU market attributes revealed in market research
Significant unmet need and market opportunity Note: Rx eligible: No. of patients calculated based on patient population aged ≥ 18 Obese with a BMI ≥ 30 *Approved Mysimba European markets 1. Orexigen internal estimates for presented to phys. and ov./ob. explicitly diagnosed Source: Orexigen models based on UN population and WHO obesity estimates Treatment eligible patients (ob.) U.S. Europe* 81 24 4 95 17 <1 Presented to physician and diagnosed1 Rx treated Millions of eligible patients 17
Phentermine Diethyl- propion Benz- pheta- mine Phendi- metrazine Gx Continuum of treatment modalities for obesity GI Lipase Inhibitor GLP-1 Injectable Diet and lifestyle counseling Surgery MOA/Route of Administration Qsymia Belviq Contrave 18
Continuum of treatment modalities for obesity Diet and lifestyle counseling Surgery GLP-1 Injectable Mysimba GI Lipase Inhibitor MOA/Route of Administration 19
Differentiated clinical profile for Mysimba™ MOA Efficacy Safety & Tolerability Metabolic Effect Mysimba supports sustained weight loss via regulation of appetite and reward-driven behavior Individual components approved and available for >30 years for depression, smoking cessation, alcohol and opioid dependence Database of >13,000 patients including preliminary CV outcomes trial Prescriber guide provided reminding of indication, safety and tolerability Most frequent adverse reactions included nausea, vomiting, dizziness, and dry mouth Special warnings and precautions for use >50% of patients with diabetes achieved ADA Guideline of <7% A1C level3 Positive impact on triglycerides and HDL 8.1% reduction in weight (18lbs/8.2kg) and a 6.2cm decrease in waist circumference at 56 wks1 34% of patients achieved a ≥10% weight loss 11.5% reduction in body weight and a 10.0cm decrease in waist circumference at 56 wks2 along with a more intensive behavior modification program 55% of patients achieved a ≥10% weight loss Indicated for adult patients (≥ 18 years) with initial BMI of ≥30kg/m2 or ≥27kg/m2 to <30kg/m2 in the presence of one or more weight-related co-morbidities (Please refer to SmPC for full prescribing information) 1COR-I (NB-301) Completer Population; 2COR-BMOD (NB-302) Completer Population; 3COR-Diabetes Full Analysis Set (Last Observation Carried Forward) 20
Many EU patients open to taking obesity prescription medicines EU 51 USA2 1. n=500 2. n=300 Source: Orexigen proprietary market research, 2015 – Patient survey 66% Would you take/continue taking a prescription drug for weight reduction? 57% 21
3 3 GI Lipase Inhibitor1 Willingness and ability to pay for obesity prescription medicines Price range Mysimba willingness/ability to pay surveys1 Market analogies Gx Branded UK reimb. in US $/day 1. Price range for unbranded Gx ~ $ 3.0 – $ 3.6, range for branded Gx ~ $ 3.7 – $ 4.7; 2. Retail price including VAT; 3. Range from marginally cheap to marginally expensive price, n = 100 per country for both patient and physician survey Source: Orexigen proprietary market research, 2015; LEK Study; IHS A B D C E A B C D E EU 5 EU 5 22
Obesity clinics in UK and Italy Source: Obesity Management Association, UK Members map, 2009, http://www.omaorg.com/index.php?option=com_gmapfp&view=gmapfplist&id_perso=1&Itemid=78; Sicob (Italian society for obesity surgery and metabolic diseases), http://www.sicob.org/; Dietologica (collaboration for nutrition and obesity, recognized by Ministry of Health, http://www.dietologica.it/centri_cura/ 23
Obesity Centers most likely to utilize obesity Rx medicines Focus Integrated centers N/A Surgery centers Behavioral/ medical oriented centers Business Volume Medical Surgical 1. Business impact is combination of prescribing potential and influence; future prescribing potential approximated with Orlistat prescribing rates (depending on data availability); influence approximated with presence of relevant KOLs in center 2. Percentages for EU5 based on results of Obesity Center mapping; percentage distribution varies by country Source: Primary market research, 2015 – Obesity center mapping EU5 24
Go to market hypothesis: Sequenced launch most efficient/effective Country specific triggers Country specific triggers Country specific triggers Phase I Phase II Phase III Patient GP Specialist Specialty Activation GP Activation Patient Activation Adherence Support GP Awareness Behavior Modification Specialty Advocacy GP Advocacy Guidelines/Reimb. 25
Go to market hypothesis : ability to leverage strategic alliances Market access Specialist Activation Pharmaco-vigilance / safety Alliance management Patient Activation Supply chain/ Manufacturing Distributors GP Activation Partner functions Brand Marketing Product Supply Pricing / Access Commercial Insights Medical Affairs Regulatory Affairs Clinical Development Lifecycle Management Orexigen strategic functions
Go to market hypothesis : general practitioner promotion via revenue sharing 1. Primary detail equivalent Revenue Revenue Share License brand A License brand B N/A Revenue/ Expense 50:50 License brand A Promote brand B N/A Expense Pay per PDE1 N/A Pay per PDE1 Co-promotion Co-marketing CSO 27
There are a broad range of synergistic adjacencies to Contrave / Mysimba Variety of close obesity related business adjacencies exist Synergistic new assets could accelerate growth and profitability Other adjacent disease areas include sleep apnea, hepato-renal treatment, orthopedic treatment, women's health Close Cardiovascular, esp. hypertension Endocrine, esp. diabetes Other obesity Rx treatment Obesity OTC treatment Functional food/nutraceuticals Mysimba in obesity centers Nutritional counseling BMOD Physical exercise 28
Broad and Growing Patent Estate Could Yield Protection Through 2034 2034 2031 2031 2029 2027 2027 2026 2024 2024/25 Binge Eating (methods) Major Depression (methods) Visceral Fat (methods) Titration / Dose Pack (methods & devices) Tri-layer (methods & compositions) Food Cravings / Titration (methods) Insulin Sensitivity (methods & compositions) Weber / Cowley (methods & compositions) Pending Issued in some territories, pending in others 2030 Nal SR (methods & compositions) For investor purposes only – not for use in product promotion Dates reflect US patent expiration Cardiovascular outcomes (methods) 29
Solid Financial Position Cash Inflows Income from Contrave® / Mysimba™ sales $15 million milestones payable by Takeda in 2016, 2017 Potential sales milestones up to $880M from Takeda over the life of the agreement Other ROW partnership income (e.g. Korea at $7m upfront) Cash Outflows Contrave estimated post-approval development obligations cash spend guidance: $35-45M (2016), $35-45M (2017) 2015 estimated net cash burn: $60-65M Cash and Investments Balance Expect to end 2015 with more than $200M For investor purposes only – not for use in product promotion 30
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