AMSTERDAM, THE NETHERLANDS, Nov. 5, 2009 (Marketwire) --
AMSTERDAM, THE NETHERLANDS -- (Marketwire) -- 11/05/09 -- Eurand N.V. (NASDAQ: EURX)
Key Achievements:
-- Received U.S. Food and Drug Administration (FDA) approval for lead
proprietary product ZENPEP(TM) (pancrelipase) Delayed-Release Capsules, a
pancreatic enzyme product (PEP) for the treatment of exocrine pancreatic
insufficiency (EPI) due to cystic fibrosis (CF) or other conditions; launch
is expected to commence by the end of November 2009
-- Grew third quarter 2009 revenues 25%, or 19% at constant currency
rates, to EUR 30.6 million ($44.8 million) compared with the same period in
2008
-- Continued to grow revenues from Pancrelipase, Eurand's unbranded PEP,
which held 21.2% of all prescriptions for coated PEPs for the week ended
October 23, 2009, according to IMS Health Incorporated
-- Increased total cash, cash equivalents and marketable securities to
EUR 31.3 million ($45.8 million) at September 30, 2009, up EUR 8.6 million
($12.5 million) from December 31, 2008
-- On October 27th, 2009, completed a public offering of 9,775,000
ordinary shares at $11.25 per share, including 2,000,000 newly issued
shares and exercise of over-allotment option of 1,275,000 shares. The net
proceeds of approximately $20.6 million from the sale of the newly issued
shares will add substantially to the Company's cash reserves.
Eurand N.V. (NASDAQ: EURX), a global specialty pharmaceutical company, today reported revenues of EUR 30.6 million ($44.8 million) for the three months ended September 30, 2009, an increase of 25%, or 19% percent at constant currency rates, from the third quarter of 2008.
The increase in revenues for the 2009 third quarter was led by strong sales of Eurand's unbranded pancreatic enzyme product, Pancrelipase, currently the second-most prescribed coated PEP with a 21.2% share of total prescriptions dispensed through October 23, 2009. Also contributing to the strong quarterly performance was continued growth in sales of partnered products, in particular ULTRASE® by Axcan and AMRIX® by Cephalon.
"Eurand had another excellent quarter, highlighted by the FDA approval of our first proprietary product, ZENPEP, as well as continued strong revenue growth and positive cash flow," said Gearóid Faherty, Chairman and Chief Executive Officer. "We eagerly await the upcoming launch of ZENPEP, which we believe lays the foundation for our long-term growth and profitability." He noted that Eurand is completing pre-launch preparations, including training its sales organization, finalizing marketing and promotional materials, and preparing launch stock for shipment.
"We continue to perform well across all areas of our business," Faherty added. "We believe that with the upcoming launch of ZENPEP, the ongoing launch of LAMICTAL® ODT(TM) by our partner GlaxoSmithKline and the continued success of our other partnered products, we are well positioned to sustain the strong revenue growth we have achieved year to date in 2009."
RECENT CORPORATE DEVELOPMENT
On October 27, 2009, Eurand completed a public offering of 9,775,000 ordinary shares, including over-allotments, at $11.25 per share. The Company intends to use the net proceeds of approximately $20.6 million from the issuance and sale of its 2,000,000 ordinary shares to fund potential product acquisitions and/or potential acquisitions of complementary businesses and research and development of additional product candidates, as well as other general corporate purposes. The remaining 7,775,000 shares were sold by current stockholders, Warburg, Pincus Equity Partners, L.P. (including two affiliated partnerships) and Warburg, Pincus Ventures International, L.P. Chairman and Chief Executive Officer Gearóid Faherty, Eurand's second-largest shareholder, elected not to sell any shares in this offering. The shares were offered through an underwriting syndicate led by Deutsche Bank Securities and BofA Merrill Lynch, together with co-managers Cowen and Company and Thomas Weisel Partners LLC.
PRODUCT DEVELOPMENT PIPELINE UPDATE:
EUR-1008 - ZENPEP(TM) (pancrelipase) Delayed-Release Capsules
-- As announced on August 28, 2009, the FDA approved ZENPEP (EUR-1008)
for the treatment of exocrine pancreatic insufficiency due to cystic
fibrosis or other conditions. ZENPEP is the only FDA-approved pancreatic
enzyme product that has been evaluated in clinical studies in adults and
children -- including children from one to seven years old -- and will
offer four dosage strengths to meet the varied needs of infants, toddlers,
adolescents and adults with EPI. ZENPEP is the sixth Eurand-developed
product to be approved by the FDA since 2001 and the second this year
following the May 8th approval of LAMICTAL® ODT(TM) (lamotrigine) Orally
Disintegrating Tablets.
-- Eurand has completed a Phase III trial with ZENPEP in patients with
chronic pancreatitis and the data are currently under evaluation.
EUR-1048 -- LAMICTAL® ODT(TM) (lamotrigine) Orally Disintegrating Tablets
-- As announced on May 11, 2009, the FDA approved EUR-1048, LAMICTAL ODT
for the treatment of Bipolar I disorder and seizures. Eurand's partner,
GlaxoSmithKline, launched LAMICTAL ODT in late June 2009. Co-developed by
Eurand andGSK, LAMICTAL ODT uses Eurand's AdvaTab® orally disintegrating
tablet and Microcaps® taste-masking technologies. In addition to
receiving an undisclosed milestone payment upon launch, Eurand earns
revenue for manufacturing LAMICTAL ODT tablets for GSK, royalties on net
sales of the product and milestone payments in connection with LAMICTAL ODT
achieving predetermined sales levels in the U.S.
EUR-1025 -- Once-Daily Formulation of Ondansetron
-- As previously disclosed, Eurand conducted two pivotal pharmacokinetic
studies of EUR-1025, a proprietary once-a-day oral modified-release
formulation of ondansetron versus an 8 mg dose of the anti-emetic drug
Zofran® (ondansetron). Based on the results of these studies, the Company
expects that EUR-1025 has a similar efficacy and safety profile as 8 mg
Zofran dosed three times a day. Eurand has recently initiated discussions
with the FDA regarding the future development of EUR-1025.
THIRD QUARTER 2009 FINANCIAL RESULTS
Total revenues were EUR 30.6 million ($44.8 million) in the third quarter of 2009, an increase of approximately 25%, or 19% at constant currency rates, compared with the third quarter of 2008.
Product sales grew 24%, or 19% at constant currency rates, to EUR 25.1 million ($36.7 million) in the third quarter of 2009 compared with the same period of 2008. This increase can be attributed mainly to sales of ULTRASE to Axcan and sales of Eurand's Pancrelipase product. Royalties were EUR 2.8 million ($4.1 million), representing an increase of 40%, or 34% at constant currency rates, compared with the third quarter of 2008, due primarily to AMRIX by Cephalon. Development fees for the third quarter of 2009 were EUR 2.7 million ($4.0 million), up 13%, or 9% at constant currency rates, from the prior year period.
