Aralez to Acquire From AstraZeneca U.S. Rights to Beta Blocker Toprol-XL®

-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 -- Aralez Pharmaceuticals Inc. (NASDAQ:ARLZ - News) (TSX:ARZ.TO - News), 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 millionin 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.

 

About Aralez Pharmaceuticals Inc.

Aralez Pharmaceuticals Inc. (NASDAQ: ARLZ and TSX: ARZ) is a global specialty pharmaceutical company focused on delivering meaningful products to improve patients' lives while creating shareholder value by acquiring, developing and commercializing products primarily in cardiovascular, pain and other specialty areas. Aralez's Global Headquarters is in Mississauga, Ontario, Canada, its U.S. Headquarters is planned to be in Princeton, NJ and the Irish Headquarters is in Dublin, Ireland. More information about Aralez can be found at www.aralez.com.

 

Cautionary Language Concerning Forward-Looking Statements 

This press release includes certain statements that constitute "forward-looking statements" within the meaning of applicable securities laws. Forward-looking statements include, but are not limited to, statements regarding transition matters and our ability to successfully integrate the acquisition of the U.S. rights to Toprol-XL and its AG, the closing of the acquisition of the U.S. rights to Toprol-XL and its AG, including the expected completion in the fourth quarter of 2016, financing the upfront payment of the acquisition of the U.S. rights to Toprol-XL and its AG under the debt facility with Deerfield Management and borrowing under such facility to replenish cash paid in connection with the recently announced ZONTIVITY acquisition, access to up to an additional $250 million in capital from Deerfield Management to fund future mutually agreeable acquisitions, payments of royalties and potential contingent milestones with respect to Toprol-XL and its AG, the distribution of the product by AstraZeneca on behalf of Aralez for up to nine months, the manufacture and supply of Toprol-XL and the AG by AstraZeneca, the benefits of Toprol-XL and its AG, the expected benefits to us of the acquisition of the U.S. rights to Toprol-XL and its AG, including that the transaction is expected to be immediately EBITDA accretive and to move profitability forward to 2017, in each case on an adjusted EBITDA basis, Toprol-XL and its AG as further broadening our cardiovascular portfolio and the acquisition as strengthening our financial profile by generating meaningful cash, offsetting launch costs for YOSPRALA and ZONTIVITY, the acquisition of the U.S. rights to Toprol-XL and its AG reflecting our ability to deliver against the expectations that we set upon our formation, that included promoting FIBRICOR, approval and commercialization of YOSPRALA, and seizing opportunities to expand through aggressive business development and licensing, and other statements that are not historical facts, and such statements are typically identified by use of terms such as "may," "will," "would," "should," "could," "expect," "plan," "intend," "anticipate," "believe," "estimate," "predict," "likely," "potential," "continue" or the negative or similar words, variations of these words or other comparable words or phrases, although some forward-looking statements are expressed differently.

You should be aware that the forward-looking statements included herein represent management's current judgment and expectations, and are based on current estimates and assumptions made by management in light of its experience and perception of historical trends, current conditions and expected future developments, as well as other factors that it believes are appropriate and reasonable under the circumstances, but there can be no assurance that such estimates and assumptions will prove to be correct and, as a result, the forward-looking statements based on those assumptions could prove to be incorrect. Accordingly, actual results, level of activity, performance or achievements or future events or developments could differ materially from those expressed or implied in the forward-looking statements. Our operations involve risks and uncertainties, many of which are outside of our control, and any one or any combination of these risks and uncertainties could also affect whether the forward-looking statements ultimately prove to be correct and could cause our actual results, level of activity, performance or achievements or future events or developments to differ materially from those expressed or implied by the forward-looking statements. These risks and uncertainties include, without limitation, our inability to build, acquire or contract with a sales force of sufficient scale for the commercialization of YOSPRALA, ZONTIVITY and FIBRICOR in a timely and cost-effective manner; our failure to successfully commercialize our products and product candidates; increased generic competition; costs and delays in the development and/or approval of our product candidates, including as a result of the need to conduct additional studies or due to issues with third-party API or finished product manufacturers, or the failure to obtain such approval of our product candidates for all expected indications, including as a result of changes in regulatory standards or the regulatory environment during the development period of any of our product candidates; the inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products, including our dependence on AstraZeneca AB and Horizon Pharma USA, Inc. for the sales and marketing of VIMOVO, our dependence on Patheon Pharmaceuticals Inc. for the manufacture of YOSPRALA, our dependence on Schering-Plough (Ireland) Company for the supply of ZONTIVITY and (following the closing of the acquisition of the U.S. rights thereto) our dependence on AstraZeneca AB for the manufacture and supply of Toprol-XL and its AG; our ability to protect our intellectual property and defend our patents; regulatory obligations and oversight; failure to successfully identify, execute, integrate and maintain new acquisitions, such as the integration of ZONTIVITY and (following the closing of the acquisition of the U.S. rights thereto) Toprol-XL and its AG; fluctuations in the value of certain foreign currencies, including the Canadian dollar, in relation to the U.S. dollar, and other world currencies; changes in government regulations, including tax laws and unanticipated tax liabilities; general adverse economic, market and business conditions; and those risks detailed from time-to-time under the caption "Risk Factors" and elsewhere in the Company's Securities and Exchange Commission ("SEC") filings and reports and Canadian securities law filings, including in our Annual Report on Form 10-K for the year ended December 31, 2015 and our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2016, which are available on EDGAR at www.sec.gov, on SEDAR at www.sedar.com, and on the Company's website atwww.aralez.com, and those described from time to time in our future reports filed with the SEC and applicable securities regulatory authorities in Canada. You should not place undue importance on forward-looking statements and should not rely upon this information as of any other date. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, unless required by law.

 

Contact Information:

Aralez Pharmaceuticals US Inc.

Nichol Ochsner

Executive Director, 

Investor Relations & Corporate Communications

732.754.2545 

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