-On an Adjusted EBITDA Basis, Transaction Expected to be EBITDA Accretive and to Move Profitability Forward to 2017-
-Company to Host Conference Call on October 4, 2016 at 8:30 a.m. ET-
MISSISSAUGA, Ontario, Oct. 4, 2016 /CNW/ -- Aralez Pharmaceuticals Inc.(NASDAQ: ARLZ) (TSX: ARZ), a global specialty pharmaceutical company, today announced it will acquire the U.S. rights to Toprol-XL® (metoprolol succinate) and its Authorized Generic (AG) pursuant to an agreement entered into between AstraZeneca and Aralez Pharmaceuticals Trading DAC, a subsidiary of Aralez. Toprol-XL is a cardioselective beta-blocker indicated for the treatment of hypertension, alone or in combination with other antihypertensives; the long term treatment of angina pectoris and treatment of stable, symptomatic (NYHA class II or III) heart failure of specific origins. It was first approved in the U.S. in 1992. AstraZeneca recorded U.S. net revenues from Toprol-XL and its AG of $89 million and $53 million in 2015 and year-to-date June 2016, respectively. The transaction is expected to be immediately EBITDA accretive and to move profitability forward to 2017, in each case on an adjusted EBITDA basis. The transaction is expected to be completed in the fourth quarter of 2016, subject to customary closing conditions.
The agreement includes an initial upfront payment of $175 million, which will be financed through a previously committed senior secured debt facility with Deerfield Management. At closing, Aralez will also borrow funds under this credit facility to replenish $25 million that was paid from cash on hand in connection with the recently announced ZONTIVITY® acquisition. In addition, Deerfield has agreed to provide Aralez access to up to an additional $250 million in capital to fund future mutually agreeable acquisitions. The transaction with AstraZeneca also includes mid-teen percentage royalties and up to $48 million of potential contingent milestone payments. In connection with the Asset Purchase Agreement, at closing the parties will enter into a Supply Agreement pursuant to which AstraZeneca will continue to manufacture and supply Toprol-XL and the AG to Aralez for at least ten years, a License Agreement with respect to certain trademarks and copyrights and a Transition Services Agreement. Under the terms of the Transition Services Agreement, AstraZeneca will continue to distribute the product on behalf of Aralez for up to nine months until the product is transferred to Aralez Pharmaceuticals Trading DAC.
"We are delighted to enter into an agreement with AstraZeneca for the U.S. rights to Toprol-XL and its AG, a beta blocker that further broadens our cardiovascular portfolio and, importantly, strengthens our financial profile by generating meaningful cash, which should accelerate our profitability to 2017 on an adjusted basis in addition to offsetting launch costs for YOSPRALA™ and ZONTIVITY," said Adrian Adams, Chief Executive Officer of Aralez. "This transaction further reflects our ability to deliver against the expectations that we set upon the formation of Aralez that included promoting FIBRICOR®, approval and commercialization of YOSPRALA, and seizing opportunities to expand through aggressive business development and licensing as evidenced by our recent acquisition of ZONTIVITY and now Toprol-XL."
Toprol-XL is an extended-release tablet that belongs to a family of high blood pressure medications known as beta-blockers. Extended-release tablets need to be taken only once a day. After swallowing Toprol-XL, the coating of the tablet dissolves, releasing a multitude of controlled release pellets filled with metoprolol succinate. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval of 24 hours.
Greenhill & Co. served as Financing Advisor and Willkie Farr & Gallagher LLP served as Legal Advisor in connection with the transaction.
Conference Call and Webcast
Aralez will host a conference call today at 8:30 a.m. ET, to discuss details of the transaction. The webcast can be accessed live and will be available for replay at www.aralez.com.
Conference Call Details
Date: Tuesday, October 4, 2016
Time: 8:30 a.m. ET
Dial-in (U.S.): 877-407-8037
Dial-in (International): 201-689-8037
About Hypertension
Hypertension, or high blood pressure, is dangerous because it makes the heart work too hard and contributes to atherosclerosis (hardening of the arteries). It increases the risk of heart disease and stroke, which are the first and third leading causes of death among Americans. High blood pressure can also result in other conditions, such as congestive heart failure, kidney disease, and blindness.
About Toprol-XL
Toprol-XL® is approved for the treatment of high blood pressure. By lowering blood pressure, Toprol-XL may lower the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. Toprol-XL is also indicated for the long-term treatment of angina pectoris, to reduce angina attacks and to improve exercise tolerance and for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin. It was studied in patients already receiving ACE inhibitors, diuretics, and, in the majority of cases, digitalis. In this population, Toprol-XL decreased the rate of mortality plus hospitalization, largely through a reduction in cardiovascular mortality and hospitalizations for heart failure.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals.
Toprol-XL is supplied as 25mg, 50mg, 100mg and 200mg tablets designed for oral administration. For full prescribing information and additional important safety information, please visit: www.TOPOL-XL.com.
Important Safety Information
Because of the possibility of serious side effects, such as chest pain or a heart attack, you should not stop taking Toprol-XL suddenly. If your doctor decides you should stop taking Toprol-XL, you may be instructed to slowly reduce your dose over a period of time before stopping it completely.
Toprol-XL may not be right for everyone, especially people who have the following health conditions:
- Extreme slowing of the heart rate.
- Sudden and severe drop in blood pressure and blood flow through the body because the heart is not pumping normally.
- Uncontrolled heart failure.
- Slowdown of the heart's electrical signal causing a slower heart rate.
- Damage to the heart's natural pacemaker that affects the heart's rhythm unless one has a pacemaker device.
- Any allergies to Toprol-XL or its ingredients.
It is important to take your medications every day as directed by your doctor.
Patients who have asthma or asthma-like lung disease should, in general, not take Toprol-XL.
Your doctor may not want you to take Toprol-XL if you are currently taking certain types of high blood pressure medicine, or have adrenal gland tumors, diabetes, low blood sugar, liver damage, overactive thyroid disease, or hardening of the arteries in the arms or legs.
Your doctor may not want you to start taking Toprol-XL if you are about to have any type of surgery.
If you have a history of serious allergic reactions, the usual dose of epinephrine (adrenaline) may not work as well if you are taking Toprol-XL.
Until you know how you will react to Toprol-XL, avoid activities that require alertness.
Contact your doctor if you have any difficulty in breathing.
In patients with high blood pressure, the most common side effects were tiredness, dizziness, depression, diarrhea, itching or rash, shortness of breath, and slow heart rate. If you experience any of these or other side effects, contact your doctor.