"The U.S. market for branded anti-obesity pharmacotherapeutics continues to develop at a substantially lower rate than expected, held in check by a number of factors," said
Third Quarter 2015 Financial Results
Total revenue was
Approximately 146,000 Qsymia prescriptions were dispensed in the current quarter, compared to 140,000 in the third quarter of 2014.
Total cost of goods sold, excluding inventory impairment, was
Total selling, general and administrative expense was
Total research and development expense was
Charges incurred for severance were approximately
Net loss was
Cash, cash equivalents and available-for-sale securities (collectively cash) totaled
Recent Business Update
Note to Investors
As previously announced,
Qsymia is approved in the U.S. and 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 medical condition such as high blood pressure, type 2 diabetes, or high cholesterol.
The effect of Qsymia on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of Qsymia in combination with other products intended for weight loss, including prescription and over-the-counter drugs, and herbal preparations, have not been established.
Important Safety Information
Qsymia® (phentermine and topiramate extended-release) capsules CIV is contraindicated in pregnancy; in patients with glaucoma; in hyperthyroidism; in patients receiving treatment or within 14 days following treatment with monoamine oxidase inhibitors (MAOIs); or in patients with hypersensitivity to sympathomimetic amines, topiramate, or any of the inactive ingredients in Qsymia.
Qsymia can cause fetal harm. Females of reproductive potential should have a negative pregnancy test before treatment and monthly thereafter and use effective contraception consistently during Qsymia therapy. If a patient becomes pregnant while taking Qsymia, treatment should be discontinued immediately, and the patient should be informed of the potential hazard to the fetus.
The most commonly observed side effects in controlled clinical studies, 5% or greater and at least 1.5 times placebo, include paraesthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth.
STENDRA® (avanafil) is approved in the U.S. by the
STENDRA is available through retail and mail order pharmacies. Endo currently offers programs that help patients with out-of-pocket costs.
SPEDRA™, the trade name for avanafil in the EU, is approved by the EMA for the treatment of erectile dysfunction in the EU.
Avanafil is licensed from Mitsubishi Tanabe Pharma Corporation (MTPC).
For more information about STENDRA, please visit www.Stendra.com.
Important Safety Information
STENDRA® (avanafil) is prescribed to treat erectile dysfunction (ED).
Do not take STENDRA if you take nitrates, often prescribed for chest pain, as this may cause a sudden, unsafe drop in blood pressure.
Discuss your general health status with your healthcare provider to ensure that you are healthy enough to engage in sexual activity. If you experience chest pain, nausea, or any other discomforts during sex, seek immediate medical help.
STENDRA may affect the way other medicines work. Tell your healthcare provider if you take any of the following; medicines called HIV protease inhibitors, such as ritonavir (Norvir®), indinavir (Crixivan®), saquinavir (Fortavase® or Invirase®) or atazanavir (Reyataz®); some types of oral antifungal medicines, such as ketoconazole (Nizoral®), and itraconazole (Sporanox®); or some types of antibiotics, such as clarithromycin (Biaxin®), telithromycin (Ketek®), or erythromycin.
In the rare event of an erection lasting more than 4 hours, seek immediate medical help to avoid long-term injury.
In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines, including STENDRA) reported a sudden decrease or loss of vision. It is not possible to determine whether these events are related directly to these medicines or to other factors. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including STENDRA, and call a doctor right away.
Sudden decrease or loss of hearing has been rarely reported in people taking PDE5 inhibitors, including STENDRA. It is not possible to determine whether these events are related directly to the PDE5 inhibitors or to other factors. If you experience sudden decrease or loss of hearing, stop taking STENDRA and contact a doctor right away. If you have prostate problems or high blood pressure for which you take medicines called alpha blockers or other anti-hypertensives, your doctor may start you on a lower dose of STENDRA.
Drinking too much alcohol when taking STENDRA may lead to headache, dizziness, and lower blood pressure.
STENDRA in combination with other treatments for ED is not recommended.
STENDRA does not protect against sexually transmitted diseases, including HIV.
The most common side effects of STENDRA are headache, flushing, runny nose and congestion.
Please see full patient prescribing information for STENDRA (50 mg, 100 mg, 200 mg) tablets.
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to risks, uncertainties and other factors, including risks and uncertainties related to our ability to eliminate expenses and reduce our headcount and fully realize the benefits from a corporate restructuring to achieve neutral or positive operating cash flows by year-end 2016, including the timing thereof; risks and uncertainties related to the impact of lower annual net cost savings than currently expected; risks and uncertainties related to the impact of a corporate restructuring on our business and unanticipated charges not currently contemplated that may occur as a result of a corporate restructuring; risks and uncertainties related to our ability to accurately forecast Qsymia demand and inventory requirements, including the
impact of a corporate restructuring on our future sales forecast and inventory; risks and uncertainties related to our ability to work with leading cardiovascular outcome trial experts in planning substantial revisions to the original design and execution of the CVOT with the goal of reducing costs and obtaining
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except per share data)|
|Three Months Ended||Nine Months Ended|
|Net product revenue||$||14,011||$||12,454||$||40,652||$||32,575|
|License and milestone revenue||-||15,070||11,574||38,614|
|Cost of goods sold||11,765||7,268||31,531||23,816|
|Selling, general and administrative||17,129||27,828||65,730||84,703|
|Research and development||1,532||2,574||6,825||11,083|
|Inventory impairment and other non-recurring charges||2,539||4,119||32,061||6,173|
|Total operating expenses||32,965||41,789||136,147||125,775|
|Loss from operations||(8,029||)||(7,912||)||(56,060||)||(33,326||)|
|Interest expense and other expense, net||8,076||8,135||24,851||24,534|
|Loss before income taxes||(16,105||)||(16,047||)||(80,911||)||(57,860||)|
|Provision for (benefit from) income taxes||1||(222||)||13||(660||)|
|Basic and diluted net loss per share||$||(0.15||)||$||(0.15||)||$||(0.78||)||$||(0.55||)|
|Shares used in per share computation:|
|Basic and diluted||104,014||103,477||103,950||103,373|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||79,496||$||83,174|
|Accounts receivable, net||14,894||11,595|
|Prepaid expenses and other assets||9,640||12,824|
|Total current assets||284,849||358,437|
|Property and equipment, net||1,121||1,346|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accrued and other liabilities||14,821||17,037|
|Current portion of long-term debt||15,080||10,459|
|Total current liabilities||59,401||57,371|
|Long-term debt, net of current portion||219,166||217,324|
|Deferred revenue, net of current portion||7,124||8,876|
|Non-current accrued and other liabilities||692||849|
|Commitments and contingencies|
|Common stock and additional paid-in capital||828,952||825,795|
|Accumulated other comprehensive (loss) income||96||(28||)|
|Total stockholders' equity||4,875||82,518|
|Total liabilities and stockholders' equity||$||291,258||$||366,938|
|* The Condensed Consolidated Balance Sheet at
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