Highlights: * EUR-1008 (Zentase(r)) NDA accepted and granted priority review status by FDA * EUR-1008 (Zentase(r)) MAA received eligibility for centralized review procedure in European Union * In-licensed corticosteroid product for inflammatory bowel disease (IBD) in the U.S. and Canada from Chiesi Farmaceutici SpA * OTC Unisom(r) SleepMelts(tm), developed by Eurand, launched in U.S. by Chattem, Inc. * Amrix(r) patent application received notice of allowance from USPTO * EUR-1025, once-daily formulation of ondansetron for the treatment and prevention of chemotherapy-induced nausea and vomiting (CINV), demonstrates positive results in pharmacokinetic study * First quarter 2008 revenues increased 24 percent year-over-year at constant currency to EUR 24.9 million ($39.3 million)
AMSTERDAM, Netherlands, May 9, 2008 (PRIME NEWSWIRE) -- Eurand N.V. (Nasdaq:EURX), a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug formulation technologies, today announced key achievements and financial results for the first quarter of 2008.
The Company disclosed recent business and regulatory developments related to its preparations for the commercial launch of its lead proprietary product candidate, EUR-1008 (Zentase(r)), currently being developed for the treatment of exocrine pancreatic insufficiency (EPI). Eurand also provided an update on Amrix(r) (cyclobenzaprine HCl), the only once-daily skeletal muscle relaxant which Eurand developed that is currently marketed in the U.S. by Cephalon, Inc., as well as updates related to the Company's most advanced product candidates, both partnered and proprietary.
Gearoid Faherty, Chief Executive Officer of Eurand, commented, "The first quarter of 2008 was marked by the achievement of many key milestones across all areas of our business. In particular, our new drug application (NDA) for EUR-1008 (Zentase(r)), was accepted by the FDA and subsequently granted priority review status, while in Europe, EUR-1008 was deemed eligible for review under the centralized procedure. The centralized procedure offers many advantages, including the possibility to gain marketing authorizations in 27 countries in one efficient process and up to 10 years of market exclusivity."
Mr. Faherty continued, "Other important highlights of the quarter include the in-licensing of Clipper(tm) from Chiesi Farmaceutici SpA, the notice of allowance for our patent application for Amrix(r) in the United States, and the commercial launch of an AdvaTab(r) product with Chattem."
PRODUCT DEVELOPMENT PIPELINE UPDATES:
EUR-1008 - Zentase(r)
* On December 20, 2007, Eurand announced the completion of its NDA
submission to the U.S. Food and Drug Administration (FDA) for
EUR-1008 (Zentase(r)), its lead product candidate intended for the
treatment of exocrine pancreatic insufficiency (EPI). The NDA was
accepted and granted priority review status by the FDA in February
2008. The typical review period for NDAs under priority review
status is six months versus the standard ten-month review period.
Pending FDA approval, Eurand intends to market the product in the
U.S. with a specialty sales force, targeting the 120 Cystic
Fibrosis Treatment Centers (CFTCs), as well as key
gastroenterologists and pulmonologists in the U.S.
Eurand intends to out-license marketing rights to EUR-1008 outside
of the U.S. and is currently in negotiations with potential
partners in Europe. In April 2008, Eurand received confirmation
from the European Medicines Evaluation Agency (EMEA) that a
marketing application for EUR-1008 is eligible for Community
(Centralized) Marketing Authorization submission in the European
Union (EU). Eurand plans to file a marketing authorization
application (MAA) for EUR-1008 with the EMEA, the approval of which
would allow market access to 27 European Union member states and
provide 10 years of market exclusivity. Eurand expects to meet with
the EMEA in the near future to define requirements for filing its
MAA.
EUR-1073 - Clipper(tm) (beclomethasone diproprionate)
* In April 2008, Eurand was granted an exclusive license by Chiesi
Farmaceutici SpA to its gastro-resistant, controlled release tablet
formulation of the corticosteroid, beclomethasone diproprionate, in
the U.S. and Canada. The product is currently approved and marketed
in the United Kingdom, Italy, Spain, and Belgium. Eurand will make
an up-front payment and commercial milestone payments to Chiesi
Farmaceutici contingent upon obtaining U.S. regulatory approval for
the product. Eurand will also pay royalties on net sales of the
product.
Marketed in Europe under the Clipper(tm) 5 mg tablets brand,
Eurand's newly in-licensed product candidate, EUR-1073, is an
enteric coated, controlled release formulation of beclomethasone
diproprionate, a corticosteroid intended for use in the treatment
of Ulcerative Colitis, the most prevalent type of inflammatory
bowel disease (IBD). EUR-1073 was developed by Chiesi using a drug
delivery system that targets the lower gastrointestinal (GI) tract,
providing a sustained release of drug upon delivery which is
intended to preserve the efficacy of classical corticosteroids
while reducing the side effects commonly associated with their use.
Eurand plans to work with the FDA to establish a clinical
development and regulatory pathway for the product in the
United States.
Unisom(r) SleepMelts(tm) - Orally Disintegrating Diphenhydramine
Hydrochloride
* In April 2008, Eurand announced that its partner, Chattem, Inc.
("Chattem"), had launched a new orally disintegrating tablet
("ODT") formulation of its popular over-the-counter (OTC) sleep-aid
brand, Unisom(r), called Unisom(r) SleepMelts(tm). The product,
which contains 25mg of diphenhydramine hydrochloride, was developed
by Eurand using its AdvaTab(r) and Microcaps(r) taste-masking
technologies as part of the EUR-1047 program. Unisom(r)
SleepMelts(tm) is now available in leading U.S. mass merchandiser,
drug and food retailers. Eurand will exclusively manufacture and
supply the product for Chattem. The launch of Unisom(r)
SleepMelts(tm) represents the first product to be commercialized
using the AdvaTab(r) ODT technology.
EUR-1002 - Amrix(r) (cyclobenzaprine HCl)
* In April 2008, Eurand received a notice of allowance from the
United States Patent and Trademark Office (USPTO) for U.S. patent
application No. 10/713,929, entitled "Modified Release Dosage Forms
of Skeletal Muscle Relaxants". Eurand's patent application was
filed November 14, 2003 and includes allowed claims covering
Amrix(r), the only FDA approved once-daily formulation of the
skeletal muscle relaxant, cyclobenzaprine hydrochloride, for the
relief of muscle spasm associated with acute, painful
musculoskeletal conditions. The extended-release formulation,
developed by Eurand using its proprietary Diffucaps(r) technology,
was launched by Eurand's partner, Cephalon, in the U.S. in November
2007. Currently marketed skeletal muscle relaxant products are
typically dosed multiple times a day and have varying degrees of
somnolence. Amrix(r) not only provides the benefit of once-daily
dosing, but Cephalon has reported that it also has a lower
incidence of somnolence compared to immediate release
cyclobenzaprine. Eurand, as the developer, licensor and exclusive
manufacturer of the product, is working with Cephalon to support
the commercialization of the product in the U.S. Eurand will
receive royalty payments and manufacturing revenue from Cephalon on
Amrix(r) sales.
FIRST QUARTER 2008 FINANCIAL RESULTS:
Total revenues were EUR 24.9 million ($39.3 million) for the first quarter 2008, representing an increase of approximately 24 percent at constant currency rates compared to the first quarter 2007. Revenues from Source CF, Eurand's recent acquisition, contributed EUR 0.9 million ($1.4 million). Product sales were EUR 20.3 million ($32.0 million), representing an increase of 17 percent at constant currency compared to the first quarter of 2007. Product sales were also higher than the fourth quarter of 2007 due to the timing of certain high value shipments. The timing of these shipments also affected product mix and consequently our margins, which were high in first quarter 2008 and low in fourth quarter 2007 compared to the preceding three quarters of 2007. Royalties were EUR 1.7 million ($2.7 million), representing an increase of 103 percent at constant currency compared to 2007. Development fees were EUR 2.9 million ($4.5 million), representing an increase of 47 percent at constant currency compared to 2007.
Research and development expenses were EUR 4.5 million ($7.1 million) for the first quarter 2008, representing an increase of 21 percent at constant currency rates compared to the first quarter 2007. Selling, general and administrative (SG&A) expenses were EUR 7.6 million ($12.0 million), representing an increase of 79 percent at constant currency compared to 2007. This increase was primarily due to increased head count and other costs associated with the build-out of the sales and marketing infrastructure for EUR-1008, the costs of public company compliance and other legal costs.
Operating income was EUR 197,000 ($311,000) for the first quarter 2008, compared to EUR 795,000 ($1.3 million) for the same quarter of 2007. The lower operating profit was primarily due to increased SG&A spending.
Financial items constituted an income of EUR 129,000 ($204,000) for the first quarter 2008, compared to an expense of EUR 1.2 million ($1.9 million) for the first quarter of 2007. This turnaround was due to the repayment of debt and increase in cash deposits from the proceeds of the Company's May 2007 IPO.
Net loss was EUR 1.0 million ($1.6 million) or EUR (0.02) per share ($(0.04) per share) for the first quarter 2008, compared to a loss of EUR 782,000 ($1.2 million) or EUR (0.02) per share ($(0.03) per share), on a pro forma per share basis for the same period in 2007.
The Company's financial position on March 31, 2008 included EUR 10.1 million ($15.9 million) of cash.
Attached to this earnings press release are two tables:
1. Selected consolidated statements of operations for the three
months ended March 31, 2008 compared to the same period in 2007
2. Selected balance sheet data
This press release contains translations of euros into U.S. dollars at a convenience rate of EUR1=$1.581, the noon buying rate at the Federal Reserve Bank of New York on March 31, 2008.
Percentage variances quoted in "Constant Currency" represent the increase or decrease recomputed as if euro/dollar exchange rates had been the same in the three months ended March 31, 2008 as they were in the same period in 2007. As a guide, average exchange rates were EUR1=$1.50 in the three months to March 31, 2008, and EUR1=$1.31 in the three months to March 31, 2007.
Conference Call Information
The Company will host a conference call on Friday, May 9, 2008 at 8:30 AM Eastern Time, 2:30 PM Central Europe Time covering the first quarter 2008 financial results.
To participate in the conference call, U.S. Participants dial 1-877-407-0789, International Participants dial +1-201-689-8562. A replay of the call will be available until June 9, 2008. To participate in the replay of the call, U.S. Participants dial 1-877-660-6853, International Participants dial +1-201-612-7415. The Account Number is: 3055, Conference ID Number: 282168.
A live web cast of the call will also be available from the Investor Relations section on the corporate web site at www.eurand.com. Following the live webcast, the archived version of the call will be available at the same URL until June 9, 2008.
About Eurand
Eurand is a specialty pharmaceutical company that develops, manufactures and commercializes enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug formulation technologies. Eurand has had four partnered products approved by the FDA since 2001 and has a pipeline of product candidates in development for itself and its collaboration partners. Eurand has completed two phase III clinical trials on its lead product candidate, EUR-1008 (Zentase(r)), intended for the treatment of pancreatic insufficiency and has submitted an NDA for this product. Eurand's technology platforms include bioavailability enhancement of poorly soluble drugs, customized release, taste-masking/fast-dissolving formulations and drug conjugation.
Eurand is a global company with facilities in the USA and Europe. For more information, visit Eurand's website at www.eurand.com.
This release, and oral statements made with respect to information contained in this release, constitutes forward-looking statements. Such forward-looking statements include those which express plan, anticipation, intent, contingency, goals, targets or future development and/or otherwise are not statements of historical fact including, but not limited to the status of our NDA filing and plans for MAA filing relating to EUR-1008, enrollment and future plans for our clinical trials, progress of and reports of results from clinical studies, clinical development plans and product development activities. The words "potentially", "could", "calls for" and similar expressions also identify forward-looking statements. These statements are based upon management's current expectations and are subject to risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. Factors that could affect actual results include risks associated with the possibility that the FDA does not approve our NDA or delays approval; the outcome of any discussions with the FDA; and unexpected delays in preparation of materials for submission to the FDA as a part of our NDA filing. Forward-looking statements contained in this press release are made as of this date, and we undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Actual events could differ materially from those anticipated in the forward-looking statements.
Selected Consolidated Statement of Operations Data
--------------------------------------------------
Three months ended March 31, % Change
2008 2008 2007 At At
current constant
$'000(a) euro'000 euro'000 currency currency
Product sales 32,019 20,259 18,706 +8% +17%
Royalty
income 2,741 1,734 974 +78% +103%
Development
fees 4,544 2,875 2,210 +30% +47%
---------- ---------- ---------- ------- -------
Total revenues 39,304 24,868 21,890 +14% +24%
Cost of goods
sold (19,036) (12,044) (12,555) -4% +4%
R & D expenses (7,093) (4,488) (3,879) +16% +21%
S,G & A
expenses (12,001) (7,593) (4,481) +69% +79%
Amortization
of intangibles (863) (546) (180) +203% +224%
---------- ---------- ---------- ------- -------
Operating
income 311 197 795 n/a n/a
Financial
income
(expense) 204 129 (1,200) n/a n/a
---------- ---------- ---------- ------- -------
Income (loss)
before taxes 515 326 (405) n/a n/a
Income taxes (2,105) (1,332) (377) n/a n/a
---------- ---------- ---------- ------- -------
Net loss (1,590) (1,006) (782) n/a n/a
========== ========== ========== ======= =======
Basic and
diluted net
loss per share $ (0.04) Euro (0.02) Euro (0.33)
Weighted
average number
of shares 44,228,749 44,228,749 2,339,686
Pro forma
basic and
diluted net
loss per share $ (0.04) Euro (0.02) Euro (0.02)(b)
Pro forma
weighted
average number
of shares
44,228,749 44,228,749 36,857,412(b)
(a) Figures in U.S. Dollars are translated from the euro, for
convenience, at a rate of 1Euro=$1.581, the noon buying rate at
the Federal Reserve Bank of New York on March 31, 2008.
(b) Presumes the conversion of all Series A preference shares into
32,487,940 ordinary shares and the conversion of all Series C
preference shares into 2,029,786 ordinary shares, as if these had
occurred on January 1, 2007.
Selected Consolidated Balance Sheet Data
----------------------------------------
March 31, December 31,
2008 2008 2007
$'000 (1) euro'000 euro'000
Cash and cash equivalents 15,898 10,059 12,541
Total debt 1,972 1,248 1,551
Total shareholders' equity (deficit) 127,967 80,966 81,067
(1) Figures in U.S. Dollars are translated from the euro, for
convenience, at a rate of 1Euro=$1.581, the noon buying rate at
the Federal Reserve Bank of New York on March 31, 2008.