(Source: Business Wire)

Biovail Corporation (NYSE/TSX: BVF) today announced its financial results for the three-month period ended March 31, 2009.
To the extent that this news release contains forward-looking statements, investors are cautioned that these are based on the Company's current views, and actual outcomes are not certain. For more information, see the note on forward-looking information following the conference-call details below.
"We are ahead of schedule with our New Strategic Focus and have proven our ability to execute," said Biovail Chief Executive Officer Bill Wells. "We acquired and launched our first specialty CNS product, tetrabenazine for Huntington's Chorea, which is performing ahead of our expectations. We have begun building a promising pipeline of specialty CNS products. On the business-development front, we are hard at work on a number of interesting opportunities. We have reinforced our base business in order to provide additional resources to accelerate our strategy through the acquisition of U.S. rights to Wellbutrin XL®, which is expected to add $200 million to $220 million in cash flow through 2010 and create substantial value for the Company. We have strengthened our senior management team and established an outstanding External Advisory Board. Perhaps most importantly, we have become a recognized and credible participant in the specialty CNS market."
Mr. Wells added, "We are making excellent progress toward implementing our New Strategic Focus and shifting Biovail to high growth, but we still have work to do. Given the current global financial environment, we are seeing numerous and unique opportunities to in-license or acquire CNS products and also have been introduced to corporate acquisition targets that might not have been otherwise available. Business development remains a top priority. We must ensure we have the resources to pursue these opportunities by reinforcing our cash flows in the base business, increasing efficiencies and ensuring we have the right capital structure. Including the incremental cash anticipated from Wellbutrin XL® and the announced change in our dividend policy, we expect additional available cash of approximately $480 million through 2010. We must also continue to build our capabilities and steadily increase our presence in the specialty CNS market. The challenges are great, but we believe the opportunities are equally large. Everyone at Biovail is highly motivated to tackle these challenges and succeed. If we are successful, Biovail will be a leader in the specialty CNS market and a high-growth company."
First-Quarter 2009 Financial Results
Total revenues for the three months ended March 31, 2009 were $173.3 million, compared with $208.5 million for the first quarter of 2008. First-quarter 2009 net income, in accordance with United States Generally Accepted Accounting Principles (GAAP), was $39.0 million, compared with $56.4 million for the corresponding 2008 period. GAAP diluted earnings per share (EPS) for the first quarter of 2009 were $0.25, versus $0.35 for the first quarter of 2008.
Specific Items Affecting First-Quarter Results
GAAP net income and EPS figures for the first quarter of 2009 were negatively impacted by a $2.7-million loss on the impairment of investments related to the Company's investment in auction-rate securities, $1.4 million in costs associated with the Securities and Exchange Commission (SEC) consultant hired as a result of the settlement of the legacy SEC proceeding, a $1.3-million restructuring charge related to the implementation of the Company's New Strategic Focus, and $0.2 million in legal settlements. In aggregate, these items negatively impacted net income and EPS in the first quarter of 2009 by $5.7 million and $0.04, respectively.
GAAP net income and EPS figures for the first quarter of 2008 were negatively impacted by a $3.6-million loss on the impairment of investments primarily related to the Company's investments in auction-rate securities, a $1.2-million equity loss related to an investment in Western Life Sciences Venture Fund and an accrual of $7.9 million for the estimated contractual obligations to terminate the long-term safety study for BVF-146 (combination of once-daily tramadol with an anti-inflammatory agent).
Acquisition of U.S. Rights to Wellbutrin XL®
Biovail also announced today that it has entered into an agreement to acquire the U.S. commercialization rights to Wellbutrin XL® (extended-release bupropion hydrochloride tablets) from GlaxoSmithKline (GSK) for total consideration of $510 million. Wellbutrin XL®, which GSK has distributed in the U.S. since September 2003, was developed by Biovail and is manufactured at the Company's Steinbach, Manitoba manufacturing facility. The agreement is subject to Hart-Scott-Rodino regulatory clearance in the U.S. For more information, see separate news release issued May 6, 2009, Biovail Announces Acquisition of U.S. Rights to Wellbutrin XL®. Biovail intends to finance this acquisition through the use of available cash and the Company's credit facility.
Pimavanserin License & Collaboration Agreement with ACADIA Pharmaceuticals
Earlier this week, Biovail announced a collaboration and license agreement with ACADIA Pharmaceuticals Inc. for the U.S. and Canadian rights to develop manufacture and commercialize pimavanserin tartrate, a new chemical entity (NCE) currently in development for the treatment of Parkinson's disease psychosis (PDP). Under the terms of the agreement, Biovail has paid to ACADIA an upfront amount of $30 million and will make additional milestone payments as pimavanserin progresses towards commercialization. For more information, see news release issued May 4, 2009, Biovail Enters Into Collaboration and License Agreement with ACADIA for Pimavanserin.
Tetrabenazine CR for Tourette Syndrome
Biovail today announced that, in partnership with Cambridge Laboratories (Ireland) Limited, a controlled-release formulation of tetrabenazine for the treatment of Tourette Syndrome (BVF-018) has been added to the Biovail's specialty CNS pipeline. Biovail is targeting a mid-2009 pre-IND meeting with the U.S. Food and Drug Administration (FDA) for this program. Tourette Syndrome is a central nervous system (CNS) disorder estimated to affect approximately 200,000 people in the U.S.
Commercial Launch of Aplenzin
In April 2009, Biovail announced the U.S. commercial launch of Aplenzin (bupropion hydrobromide) extended-release tablets by sanofi-aventis US. Aplenzin was approved by the FDA in April 2008 at dosage strengths of 174mg, 348mg and 522mg for the treatment of major depressive disorder (MDD). The 522mg dosage strength of Aplenzin represents the only FDA-approved single-tablet, once-daily treatment option equivalent to 450mg of bupropion hydrochloride therapy, which requires two or three tablets daily.
Establishment of External Advisory Board
In March 2009, Biovail announced the formation of an External Advisory Board (EAB) to oversee and provide medical, scientific, and commercial input into the Company's development-pipeline efforts in specialty CNS disorders.
Biovail's EAB is comprised of Franklin M. Berger, Dr. Mark A. Cochran, Dr. Kathleen Clarence-Smith, Dr. Robert H. Lenox, Dr. Karoly Nikolich and Dr. Ian Ragan. These exceptional professionals bring a wealth of academic, business and product-development expertise and acumen to Biovail. For more information, please see news release issued March 27, 2009, Biovail Announces Establishment of External Advisory Board.
Restructuring Update
In consideration of the Company's shift in its research-and-development focus from reformulation opportunities to the in-licensing and development of specialty CNS programs, Biovail has decided to close its research and development (R&D) site in Mississauga, Ontario, and to streamline its R&D operations in Chantilly, Virginia. The Chantilly operation, currently housed in two buildings, will be consolidated into a single building and will assume the Pharmaceutical Science and Technology Transfer functions currently performed at Biovail's Mississauga R&D site. This initiative, which will retain our strong expertise in formulation, clinical development and regulatory affairs, will reduce headcount by approximately 50 employees, and is expected to reduce R&D overhead by approximately $8 million annually. Restructuring charges of approximately $4 million and other costs of approximately $2.2 million are expected to be incurred largely in the second quarter of 2009. Biovail continues to target an investment in R&D of $600 million in the 2008 to 2012 timeframe.
The ongoing closure of Biovail's manufacturing facilities in Puerto Rico remains on track to be completed by early 2010. The two Puerto Rico facilities, and the previously closed R&D facility in Dublin, Ireland, remain on the market to be sold.
Biovail's restructuring and expense reduction opportunities have proven to be greater than originally anticipated. Consequently, Biovail is increasing its cost reduction target to $40 million to $60 million annually beginning in 2010. Total write-offs and restructuring charges associated with this effort are now expected to be in the range of $100 million to $120 million (previously $80 million to $100 million), of which the estimated cash component remains in the range of $20 million to $40 million. To date, $75.6 million of these charges have been incurred.
Balance Sheet & Cash Flow
At the end of the first quarter of 2009, Biovail had cash and cash equivalents of $297.7 million, marketable securities valued at $20.7 million, and no borrowings under its $250-million committed credit facility.
Cash flow from operations was $47.0 million in the first quarter of 2009, compared with $92.7 million in the first quarter of 2008 ($66.9 million and $73.9 million, respectively, before changes in operating assets and liabilities), which primarily reflects lower net income in 2009 and a decrease of $21.7 million related to the change in accounts receivable, reflecting a higher level of receipts in the first quarter of 2008. Net capital expenditures in the first quarter of 2009 amounted to $0.8 million, compared with $9.7 million in the prior-year period. Going forward, capital expenditures are expected to remain significantly below historical levels as a result of the closure or consolidation of the Company's facilities in Puerto Rico, Ireland, Mississauga and Chantilly, and the availability of capacity in Biovail's Steinbach manufacturing facility. In 2009, Biovail anticipates capital expenditures to be in the range of $5 million to $10 million.
First-Quarter 2009 Financial Performance
Product revenues for the first quarter of 2009 were $165.4 million, compared with $196.9 million in the first quarter of 2008. This decline is primarily due to lower revenues from Wellbutrin XL®, the Zovirax® line, Ultram® ER, Cardizem® LA and the impact of a weaker Canadian dollar on the sales of Biovail Pharmaceuticals Canada (BPC). Partially offsetting factors include the strong performance of Biovail's Legacy products, and the inclusion of revenues from Xenazine®/Nitoman® and Aplenzin in the first quarter of 2009. Excluding Wellbutrin XL®, total product revenues were $145.3 million in the first quarter of 2009, compared with $138.1 million in the prior-year period, an increase of 5%.
Launched in November 2008 by Biovail's marketing partner Ovation Pharmaceuticals, Inc, (acquired by H. Lundbeck A/S in February 2009), Xenazine® generated first-quarter 2009 revenues of $6.7 million. Through April 9, 2009, the product's total prescription volume and average daily dose remain above initial expectations. In Canada, Nitoman® generated revenue of $1.0 million in the first quarter of 2009, which is included in Biovail Pharmaceutical Canada's revenues.
Aplenzin generated revenues of $3.8 million in the first quarter of 2009, which represented launch quantities and samples shipped to Biovail's marketing partner sanofi-aventis US prior to the product's April 2009 U.S. commercial launch.
Product revenues for Wellbutrin XL® were $20.1 million in the first quarter of 2009, compared with $58.9 million in the first quarter of 2008. This decrease reflects the introduction of a generic formulation of the 150mg strength of the product in May 2008.
First-quarter 2009 revenues for Biovail's Zovirax® franchise were $32.9 million, compared with $37.1 million in the prior-year period, reflecting a 5% decrease in prescription volume and a reduction in inventories at the wholesaler level, partially offset by price increases.