(Source: Business Wire)

AMRI (NASDAQ: AMRI) today reported financial and operating results for the second quarter ended June 30, 2009.
Financial and other significant events for the quarter include:
Receipt of a $4 million milestone payment from Bristol-Myers Squibb Company for the submission of a Clinical Trial Application (CTA) by BMS to initiate Phase I studies on an AMRI compound exclusively licensed to BMS
Large scale revenue growth of 18% or $2.9 million from the quarter ended June 30, 2008
Recurring royalty increase of 13% in the second quarter of 2009 to $8.5 million, compared to $7.6 million in 2008
A $1.9 million, or $0.04 per basic and diluted share, non-cash inventory write-down related to legacy generic inventories
Second Quarter 2009 Results
Total revenue for the second quarter of 2009 was $51.3 million, a decrease of 11% compared to total revenue of $57.9 million reported in the second quarter of 2008.
Total contract revenue for the second quarter of 2009 was $38.8 million, a decrease of 16% compared to total contract revenue of $46.4 million reported in 2008. Total contract revenue encompasses revenue from AMRI's Discovery Services, Development and Small Scale Manufacturing, and Large Scale Manufacturing business components.
Discovery Services contract revenue for the second quarter was $11.5 million, a decrease of 22% from $14.8 million in 2008
Development/Small Scale Manufacturing contract revenue for the second quarter was $8.1 million, a decrease of 47% from $15.3 million in 2008
Large Scale Manufacturing contract revenue for the second quarter was $19.2 million, an increase of 18% from $16.3 million in 2008
Recurring royalties in the second quarter of 2009 were $8.5 million, an increase of 13% compared to recurring royalties of $7.6 million reported in 2008. AMRI earns royalties from worldwide sales of the non-sedating antihistamine Allegra® (Telfast® outside the United States), as well as certain generic forms of Allegra®, for patents relating to the active ingredient in Allegra®.
Milestone revenue resulting from the company's 2005 licensing agreement with BMS was $4 million in the second quarter of 2009. In May, AMRI announced that a Clinical Trial Application (CTA) had been filed in Sweden related to an AMRI compound being developed under its license and research agreement with BMS, triggering the payment to AMRI. This is the second AMRI compound from this collaboration to be selected by Bristol-Myers Squibb for Phase I testing. BMS initiated a Phase I study on a separate AMRI compound in Canada in June 2008.
Second quarter 2009 results include $1.9 million, or $0.04 per basic and diluted share, of non-cash inventory write-downs primarily related to a legacy generic API.
Net income under U.S. Generally Accepted Accounting Principles (U.S. GAAP) in the second quarter of 2009 was $179,000 or $0.01 per basic and diluted share, compared to net income of $5.7 million or $0.18 per basic and diluted share in the second quarter of 2008.
Year-to-Date
Total revenue for the six-month period ended June 30, 2009 was $105.3 million, a decrease of $6.2 million or 6% compared to $111.5 million for the same period in 2008.
Total contract revenue for the first six months of 2009 of $82.0 million represented a decrease of $9.7 million or 11% over the same period in 2008.
Contract revenue for Discovery Services in the six-month period ended June 30, 2009 was $23.1 million, a decrease of 18% from $28.2 million in 2008
Contract revenue for Development/Small Scale Manufacturing in the six-month period ended June 30, 2009 was $19.0 million, a decrease of 33% from $28.5 million in 2008
Contract revenue for Large Scale Manufacturing in the six-month period ended June 30, 2009 was $39.9 million, an increase of 14% compared to $35.0 million in the six-month period ended June 30, 2008
Milestone revenue resulting from the company's 2005 licensing agreement with BMS for the first half of 2009 was $4 million, compared to total milestone revenue of $4 million in the first half of 2008.
Recurring royalties from Allegra® for the first six months of 2009 were $19.3 million, an increase of 22% compared to royalty revenue of $15.8 million in 2008.
Net income under U.S. GAAP in the first half of 2009 was $2.1 million or $0.07 per basic and diluted share, compared to net income of $10.4 million or $0.33 per basic and diluted share in the first half of 2008.
For a reconciliation of net income and earnings per diluted share as reported to adjusted net income and earnings per diluted share for the 2009 and 2008 reporting period, please see Table 1 at the end of this press release.
AMRI Chairman, President and CEO Thomas E. D'Ambra said, "The business climate for our contract services business continues to be challenging during this economic downturn. Our revised financial guidance reflects primarily a demand for our Development/Small Scale business at lower than historical levels. We are continuing to implement cost containment activities by both restricting expenditures and streamlining operations, with the objective of returning our core contract business to cash flow positive results in 2010. We believe these efforts position us to realize a more rapid return to profitability when growth returns in this segment of our business. We continue to believe that long term prospects for outsourcing remain strong and that AMRI is uniquely and well positioned in our space."
Dr. D'Ambra continued, "With regard to our R&D efforts, we are utilizing our scientific resources and investing to improve the manufacturing process for several of our legacy generic products, as well as our own proprietary tubulin inhibitor compound, currently in Phase I testing. On the proprietary R&D front, our MCH-1 receptor antagonist program, offering a promising new approach for the treatment of obesity, advanced into preclinical testing this quarter, our sixth program to advance into this stage. As evidenced by the success of our collaboration with BMS and the Allegra® royalty revenues we have generated to date, we are confident in the potential for our proprietary development activities to drive significant value by generating additional milestone and royalty revenues in the future."
Liquidity and Capital Resources
At June 30, 2009, AMRI had cash, cash equivalents and marketable securities of $100.4 million, compared to $87.5 million at December 31, 2008.
Total debt at June 30, 2009 was $13.5 million, down from $13.7 million at December 31, 2008. Cash, cash equivalents, and marketable securities, net of debt, were $86.9 million at June 30, 2009. Total common shares outstanding, net of treasury shares, were 31,630,453 at June 30, 2009.
The increase of $12.9 million in cash, cash equivalents and marketable securities in the first half of 2009 was due to operating cash flows of $24.8 million, driven primarily by the receipt of a $10 million sub-license fee from sanofi-aventis U.S. LLC and the collection of customer receivables. These increases in cash and equivalents were partially offset by capital expenditures of $11.9 million.
2009 Financial Guidance Update
AMRI Chief Financial Officer Mark T. Frost provided contract revenue and earnings per share ("EPS") guidance for the third quarter and revised guidance for the full year 2009. "In the third quarter, we expect contract revenue to range from $37 million to $41 million, a decrease of 24% to 32% from the third quarter of 2008. For the full year 2009, we expect contract revenue to range from $154 million to $162 million, a decrease of 17% to 21% versus 2008."
Mr. Frost continued, "With regard to our royalty revenues from worldwide sales of Allegra® and certain generic forms of Allegra®, we expect third quarter royalties of approximately $6 to $7 million and full year 2009 royalties of approximately $32 to $34 million. For the third quarter, we expect a loss per share of between $0.02 and $0.05.