Eurand N.V. (NASDAQ: EURX)
Recent Developments:
-- Fourth quarter 2009 revenues were EUR 30.3 million ($43.4
million), up 18%, or 28% in constant currency, from the fourth
quarter of 2008.
-- Full-year revenues in 2009 grew to a record EUR 120.6 million
($172.8 million), up 22%, or 18% in constant currency, from
2008.
-- November 2009, launched lead proprietary product ZENPEP®
(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.
-- Granted patent for ZENPEP that will provide protection until
at least February 20, 2028.
-- Increased total cash, cash equivalents and marketable
securities to EUR 39.9 million ($57.2 million) at December 31,
2009, up EUR 17.2 million ($24.7 million) from December 31, 2008.
As previously disclosed, this includes $20.1 million in cash from
the net proceeds of a public offering of 2,000,000 newly issued
shares at $11.25 per share, completed October 27, 2009.
Eurand N.V. (NASDAQ: EURX), a global specialty pharmaceutical
company, today reported revenues for the fourth quarter of 2009 of
EUR 30.3 million ($43.4 million), a 28% increase in constant
currency from the fourth quarter of 2008. For the year ended
December 31, 2009, revenues grew to a record EUR 120.6 million
($172.8 million), up 18% in constant currency from 2008.
"Eurand completed another strong quarter, highlighted by the
launch of ZENPEP," said Gearóid Faherty, Chairman and Chief
Executive Officer. "In addition, we expanded our commercial
organization to support ZENPEP and completed a secondary offering
that increased our cash balance. The quarter capped off another
outstanding year for Eurand that included two new drug approvals
and a significant increase in revenues. As 2010 unfolds, we look
forward to another successful year, led by the ongoing launch of
ZENPEP and continuing growth from several key partnered products
such as AMRIX®, LAMICTAL® ODT™ and ULTRASE®."
The strong growth in 2009 can be attributed primarily to
revenues from Pancrelipase and from partnered products, AMRIX, a
once-daily skeletal muscle relaxant marketed by Cephalon, and
ULTRASE, a PEP marketed by Axcan. Cephalon reported AMRIX sales of
$30.6 million for the fourth quarter of 2009, a 17% increase from
the fourth quarter of 2008, and $114.4 million for the full year in
2009, up 55% from 2008. Eurand also benefited from revenues from
LAMICTAL ODT, launched by GlaxoSmithKline in mid-2009 as a
treatment for bipolar I disorder and epileptic seizures.
ZENPEP Launch Update
On November 30, 2009, Eurand announced the commercial
availability of ZENPEP, with sales support provided by a specialty
CF sales force composed of 16 Eurand sales people targeting the 120
accredited CF centers, satellites and other specialists who treat
CF. In addition, the Company contracted with Innovex, a Quintiles
company, to promote ZENPEP to other high-volume PEP prescribers who
commonly treat patients with EPI associated with other conditions
such as chronic pancreatitis, pancreatic cancer and gastric
surgery. These 49 Innovex sales professionals call on key
gastroenterologists, internal medicine specialists, family-practice
physicians and oncologists.
Eurand continued to ship its low cost Pancrelipase product to
wholesalers until the launch of ZENPEP in late November. In
mid-December 2009, Eurand introduced PANCRELIPASE™ 5000, an
authorized generic (AG) to the 5,000 unit dose of ZENPEP. The AG is
intended to retain the market share the unbranded Pancrelipase
captured in 2009 in the low-dose segment of the gastroenterology
market, which historically has moved to the lowest-cost
product.
For the week ended February 19, 2010, Eurand's total
pancrelipase franchise (including Pancrelipase, ZENPEP, and the AG,
PANCRELIPASE 5000) held 16.1% of total prescriptions in the coated
PEP market, according to IMS Health Incorporated. Performance by
product is as follows:
Share of Coated
Eurand Products Total Weekly Rx* PEP Market*
---------------- ---------------
Pancrelipase 2,262 12.3%
---------------- ---------------
ZENPEP 433 2.3%
---------------- ---------------
PANCRELIPASE 5000 280 1.5%
---------------- ---------------
Total 2,975 16.1%
---------------- ---------------
*Source: IMS Health Incorporated
The Company noted that several factors have influenced ZENPEP's
and its AG's uptake, including an extensive initial sampling
program, continued availability of Pancrelipase and the ongoing
efforts to obtain full Medicaid and Medicare Part D reimbursement,
which Eurand anticipates completing by the end of the first quarter
of 2010.
"We expect to see prescription volume increase in the second
quarter of 2010 as physicians and patients gain experience with
ZENPEP from the sampling program, as Pancrelipase inventory is
depleted and as the process for securing reimbursement for ZENPEP
is completed," said Faherty. He added that the competitive
landscape should be resolved following the FDA's April 28, 2010
deadline for approval of New Drug Applications for PEPs. Including
ZENPEP, only two of the five currently marketed PEPs are
FDA-approved.
ZENPEP Patent Granted
As announced on February 16, 2010, the U.S. Patent and Trademark
Office granted U.S. Patent No. 7,658,918, entitled "STABLE
DIGESTIVE ENZYME COMPOSITIONS". The patent should provide Eurand
with protection on ZENPEP until at least February 20, 2028.
PRODUCT DEVELOPMENT PIPELINE UPDATE:
EUR-1008 - ZENPEP® (pancrelipase) Delayed-Release Capsules
-- During the fourth quarter, the European Medicines Evaluation
Agency (EMEA) finalized its draft guidelines on the clinical
development and evaluation of medicinal products, including PEPs,
for the treatment of cystic fibrosis. Eurand recently received
feedback from the EMEA on the clinical and regulatory path forward
for EUR-1008 in light of the guidelines, and the Company
anticipates initiating a Phase III study in Europe in the second
half of 2010.
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 labeled dosages
of 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. During the fourth quarter, Eurand met with
the FDA to present these data and discuss the future development of
EUR-1025. Based on the outcome of this meeting, the Company expects
to submit to the FDA in the first half of 2010 a protocol for a
Phase III study in post-operative nausea and vomiting.
EUR-1073 - CLIPPER™ (beclomethasone dipropionate)
-- Chiesi Farmaceutici S.p.A., the licensor of EUR-1073, a
proprietary development product for the treatment of ulcerative
colitis, has completed a Phase IIIb clinical study in Europe
comparing CLIPPER™ to the current standard of care, prednisolone,
in ulcerative colitis. The results of this study showed that
CLIPPER met the primary efficacy endpoint of non-inferiority.
Eurand is currently evaluating the future course of development of
EUR-1073 in view of competitive positioning and other pipeline
opportunities.
FOURTH QUARTER 2009 FINANCIAL RESULTS
Total revenues were EUR 30.3 million ($43.4 million) in the
fourth quarter of 2009, an increase of approximately 18%, or 28% at
constant currency rates, compared with the fourth quarter of
2008.
Product sales grew 34%, or 45% at constant currency rates, to
EUR 25.9 million ($37.1 million) in the fourth 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 2.6 million ($3.7
million), up 4% at constant currency rates from the fourth quarter
of 2008. Development fees for the fourth quarter of 2009 were EUR
1.8 million ($2.6 million), down 50%, or 46% at constant currency
rates, from the prior year period. Revenue from development fees
can fluctuate from quarter to quarter because a significant portion
of fees is recognized upon achievement of development
milestones.
Cost of goods sold was EUR 15.9 million ($22.8 million) for the
three months ended December 31, 2009, up 12%, or 22% at constant
currency rates, compared with the same period in 2008. The margin
on product sales was 38.5% versus 26.4% in the fourth quarter of
2008, reflecting the increased proportion of higher margin products
within the total product sales figure.
Research and development (R&D) expenses were EUR 5.4 million
($7.7 million) for the three months ended December 31, 2009, down
25%, or 19% at constant currency rates, compared with the same
period in 2008. Selling, general and administrative (SG&A)
expenses of EUR 12.9 million ($18.5 million) were up 78%, or 95% at
constant currency rates, compared with the fourth quarter of 2008.
The increase in SG&A expenses is due primarily to costs
associated with the launch of ZENPEP, including the expansion of
Eurand's sales force, product sampling and marketing and
patient-support programs.
The operating loss for the fourth quarter of 2009 was EUR 4.6
million ($6.6 million) versus an operating loss of EUR 3.2 million
($4.6 million) in the comparable period of 2008. Tax expense was an
income of EUR 458,000 ($657,000) versus an income of EUR 403,000
($578,000) in the fourth quarter of 2008. Net loss for the fourth
quarter of 2009 was EUR 3.9 million ($5.6 million) or EUR (0.08)
per diluted share ($(0.12) per share). Net loss for the fourth
quarter of 2008 was EUR 2.8 million ($4.0 million), or EUR (0.06)
per diluted share ($(0.09) per share).
At December 31, 2009, cash, cash equivalents and marketable
securities totaled EUR 39.9 million ($57.2 million). This included
$20.1 million in cash from the net proceeds of a public offering of
2,000,000 shares completed on October 27, 2009.
YEAR-TO-DATE 2009 FINANCIAL RESULTS
For the year ended December 31, 2009, total revenues were EUR
120.6 million ($172.8 million), an increase of approximately 22%,
or 18% at constant currency rates, compared with 2008. The increase
in revenues can be attributed primarily to sales of Pancrelipase
and sales of ULTRASE to Axcan, and to higher royalties, notably
from AMRIX by Cephalon.
Product sales grew 24%, or 20% at constant currency rates, to
EUR 99.0 million ($141.9 million) in 2009 compared with 2008.
Royalties of EUR 10.7 million ($15.3 million) were up 32%, or 25%
at constant currency rates, compared with 2008. Development fees
were EUR 10.9 million ($15.6 million), up 4%, or down 1% at
constant currency rates, from the prior year.
Cost of goods sold was EUR 61.2 million ($87.7 million) for the
year ended December 31, 2009, up 14% from the prior year, or 12% at
constant currency rates. The margin on product sales was 38.2% in
2009 versus 32.7% in 2008, reflecting the increased proportion of
higher margin pancreatic enzyme products within the total product
sales figure.
R&D expenses were EUR 23.6 million ($33.8 million) in 2009,
up 16%, or 12% at constant currency rates, compared with 2008.
SG&A expenses of EUR 37.4 million ($53.6 million) were up 23%,
or 22% at constant currency rates, versus 2008.
For the full-year 2009, operating loss was EUR 3.4 million ($4.8
million). For 2008, operating result was an income of EUR 16.9
million ($24.2 million). On September 5, 2008, Eurand received $25
million in cash from UCB, Inc. as part of a $35 million litigation
settlement. This translated at the then current exchange rate of
approximately EUR1=$1.43 into a gain of EUR 24.4 million ($35.0
million at the convenience rate) and was recorded as income from
litigation settlement, a component of Eurand's operating income for
the year ended December 31, 2008. Excluding the impact of this
gain, operating result in 2008 would have been a loss of EUR 7.5
million ($10.7 million).
The net loss for 2009 was EUR 5.9 million ($8.5 million), or EUR
(0.13) per diluted share ($(0.18) per share). Net income for 2008
was EUR 13.6 million ($19.5 million), or EUR 0.29 per diluted share
($0.42 per share). Excluding the impact of the gain attributable to
the settlement of EUR 24.4 million ($35.0 million at the
convenience rate) and an estimate of related tax effect, net income
would have been a loss of approximately EUR 10.6 million ($15.2
million), or EUR (0.24) per diluted share ($(0.34) per share), in
2008.
Attached to this news release are three items:
1. Selected consolidated statements of operations for the three
months ended December 31, 2009 compared with the same period in
2008
2. Selected consolidated statements of operations for the year
ended December 31, 2009 compared with the same period in 2008
3. Selected balance sheet data as of December 31, 2009 and
2008
This news release contains translations of euros into U.S.
dollars at a convenience rate of EUR1=$1.4332, the noon buying rate
at the Federal Reserve Bank of New York on December 31, 2009.
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 December 31, 2009 as
they were in the same period in 2008. As a guide, average exchange
rates were EUR1=$1.478 in the three months to December 31, 2009,
EUR1=$1.393 in the 12 months to December 31, 2009, EUR1=$1.317 in
the three months to December 31, 2008 and EUR1=$1.471 in the 12
months to December 31, 2008.
Conference Call Information
Eurand will host a conference call today, Thursday, March 4,
2010 at 8:30 a.m. Eastern Time, 2:30 p.m. Central Europe Time,
covering the fourth quarter and full-year 2009 financial
results.
To participate in the conference call, U.S. participants dial
1-877-407-9039, international participants dial +1-201-689-8470. A
replay of the call will be available until April 4, 2010. 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: 343839.
A live web cast of the call will also be available from the
investor relations section of the company website at
www.eurand.com. Following the live webcast, the archived version of
the call will be available at the same URL until April 4, 2010.
About Eurand
Eurand is a specialty pharmaceutical company that develops,
manufactures and commercializes enhanced pharmaceutical and
biopharmaceutical products based on its proprietary pharmaceutical
technologies. Eurand has had six products approved by the FDA since
2001 and has a pipeline of product candidates in development for
itself and its collaboration partners. Its technology platforms
include bioavailability enhancement of poorly soluble drugs, custom
release profiles and taste-masking orally disintegrating tablet
(ODT) formulations.
Eurand is a global company with facilities in the U.S. and
Europe. For more information, visit Eurand's website at
www.eurand.com.
Forward-Looking Statement
This release and oral statements made with respect to
information contained in this release, including statements about
the potential of ZENPEP to treat Exocrine Pancreatic Insufficiency,
constitute 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. The words "expects",
"potentially", "anticipates", "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 our ability to
market, commercialize and achieve market acceptance for ZENPEP or
to develop or partner any of our other products. A non-exclusive
list of important factors that may affect future results may be
found in Eurand's filings with the Securities and Exchange
Commission, including its Form F-3, annual report on Form 20-F and
periodic reports on Form 6-K. Investors should evaluate any
statement in light of these important factors. 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.
Item 1. Selected consolidated statements of operations for the
three months ended December 31, 2009 compared with the same period
in 2008
Three months ended December 31,
2009 2009 2008 % Change
At At
current constant
$'000(a) euro'000 euro'000 currency currency
Product sales 37,060 25,858 19,257 34% 45%
Royalty income 3,715 2,592 2,770 -6% 4%
Development
fees 2,651 1,850 3,677 -50% -46%
---------- ---------- ---------- ---------- ----------
Total revenues 43,426 30,300 25,704 18% 28%
Cost of goods
sold (22,782) (15,896) (14,179) 12% 22%
R & D expenses (7,698) (5,371) (7,117) -25% -19%
S,G & A
expenses (18,478) (12,893) (7,260) 78% 95%
Amortization of
intangibles (473) (330) (283) 17% 25%
Other expenses (595) (415) (50) N.M. N.M.
---------- ---------- ---------- ---------- ----------
Operating loss (6,600) (4,605) (3,185) N.M. N.M.
Financial
income
(expense), net 305 213 (8) N.M. N.M.
---------- ---------- ---------- ---------- ----------
Loss before
taxes (6,295) (4,392) (3,193) N.M. N.M.
Income taxes 657 458 403 N.M. N.M.
---------- ---------- ---------- ---------- ----------
Net loss (5,638) (3,934) (2,790) N.M. N.M.
========== ========== ========== ========== ==========
Basic and
diluted net
loss per share $ (0.12) EUR (0.08) EUR (0.06)
Weighted
average number
of shares used
to compute
basic and
diluted loss
per share 47,263,014 47,263,014 45,615,976
(a) Figures in U.S. dollars are translated from the euro for convenience,
at a rate of 1Euro=$1.4332, the noon buying rate at the Federal
Reserve Bank of New York on December 31, 2009.
Item 2. Selected consolidated statements of operations for the
year ended December 31, 2009 compared with the same period in
2008
Year ended December 31,
2009 2009 2008 % Change
At At
current constant
$'000(a) euro'000 euro'000 currency currency
Product sales 141,900 99,009 79,932 24% 20%
Royalty income 15,342 10,705 8,140 32% 25%
Development
fees 15,600 10,885 10,464 4% -1%
---------- ---------- ---------- ---------- ----------
Total revenues 172,842 120,599 98,536 22% 18%
Cost of goods
sold (87,745) (61,223) (53,811) 14% 12%
R & D expenses (33,776) (23,567) (20,291) 16% 12%
S,G & A
expenses (53,599) (37,398) (30,516) 23% 22%
Amortization of
intangibles (1,960) (1,368) (1,361) 1% -3%
Other expenses (595) (415) (50) N.M. N.M.
Income from
litigation
settlement - - 24,404 N/A N/A
---------- ---------- ---------- ---------- ----------
Operating
income (loss) (4,833) (3,372) 16,911 N.M. N.M.
Financial
income, net 231 161 357 N.M. N.M.
---------- ---------- ---------- ---------- ----------
Income (loss)
before taxes (4,602) (3,211) 17,268 N.M. N.M.
Income taxes (3,860) (2,693) (3,639) N.M. N.M.
---------- ---------- ---------- ---------- ----------
Net income
(loss) (8,462) (5,904) 13,629 N.M. N.M.
========== ========== ========== ========== ==========
Basic net
income (loss)
per share $ (0.18) EUR (0.13) EUR 0.30
Diluted net
income (loss)
per share $ (0.18) EUR (0.13) EUR 0.29
Weighted
average number
of shares used
to compute
basic income
(loss) per
share 46,136,546 46,136,546 44,921,051
Weighted
average number
of shares used
to compute
diluted income
(loss) per
share 46,136,546 46,136,546 46,377,076
(a) Figures in U.S. dollars are translated from the euro for convenience,
at a rate of 1Euro=$1.4332, the noon buying rate at the Federal Reserve
Bank of New York on December 31, 2009.
Item 3. Selected balance sheet data as of December 31, 2009 and
2008
December 31, December 31,
2009 2009 2008
$'000 (1) euro'000 euro'000
Cash and cash equivalents 24,211 16,893 19,146
Marketable securities 33,034 23,049 3,592
Total debt 297 207 186
Total shareholders' equity 159,908 111,574 102,102
Figures in U.S. dollars are translated from the euro for convenience, at
a rate of 1Euro=$1.4332, the noon buying rate at the Federal Reserve Bank
of New York on December 31, 2009.
Contacts: Bill Newbould Vice President, Investor Relations
Eurand N.V. +1 267-759-9335 Email Contact Nick Laudico/Sara
Pellegrino The Ruth Group +1 646-536-7030/7002 Email Contact Email
Contact
Eurand N.V. (MM) (NASDAQ:EURX)
Historical Stock Chart
From Jul 2024 to Aug 2024
Eurand N.V. (MM) (NASDAQ:EURX)
Historical Stock Chart
From Aug 2023 to Aug 2024
