SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
6-K
REPORT
OF FOREIGN PRIVATE ISSUER
PURSUANT
TO RULE 13a-16 OR 15d-16 UNDER
THE
SECURITIES EXCHANGE ACT OF 1934
For
the month of August 2010
001-33444
(Commission
File Number)
Eurand
N.V.
(Exact
Name of Registrant as Specified in Its Charter)
Not
Applicable
(Translation
of registrant’s name into English)
Olympic
Plaza
Fred.
Roeskestraat 123
1076
EE Amsterdam, The Netherlands
(Address
of principal corporate office)
Indicate
by check mark whether the registrant files or will file annual reports under
cover Form 20-F or Form 40-F: Form 20-F
þ
Form 40-F
o
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(1):
o
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(7):
o
Indicate
by check mark whether the registrant by furnishing the information contained in
this Form is also thereby furnishing the information to the Commission pursuant
to Rule 12g3-2(b) under the Securities Exchange Act of 1934: Yes
o
No
þ
If “Yes”
is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b): 82-
Index to
Form 6-K
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Page
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Part
I
|
Unaudited
Condensed Consolidated Financial Information
|
|
|
|
|
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|
1
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19
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PART
I. UNAUDITED CONDENSED CONSOLIDATED FINANCIAL INFORMATION
EURAND
N.V.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In
thousands of euros)
|
|
June
30,
2010
(Unaudited)
|
|
|
December
31, 2009
(Note
2)
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
Current
Assets
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
|
20,720
|
|
|
|
16,893
|
|
Marketable
securities
|
|
|
17,572
|
|
|
|
23,049
|
|
Accounts
receivable, less allowance for doubtful accounts of €431 and €436,
respectively
|
|
|
21,347
|
|
|
|
21,331
|
|
Inventories,
net
|
|
|
19,494
|
|
|
|
15,633
|
|
Prepaid
expenses and other current assets
|
|
|
10,526
|
|
|
|
9,041
|
|
Deferred
income taxes
|
|
|
2,148
|
|
|
|
2,086
|
|
Total
Current Assets
|
|
|
91,807
|
|
|
|
88,033
|
|
|
|
|
|
|
|
|
|
|
Non-Current
Assets
|
|
|
|
|
|
|
|
|
Property,
plant and equipment, net of accumulated depreciation of €79,230 and
€73,145 , respectively
|
|
|
37,301
|
|
|
|
35,596
|
|
Goodwill
|
|
|
28,315
|
|
|
|
26,818
|
|
Other
intangible assets, net of accumulated amortization of €6,793 and €5,720,
respectively
|
|
|
6,353
|
|
|
|
6,288
|
|
Deferred
income taxes
|
|
|
84
|
|
|
|
1,133
|
|
Other
non-current assets
|
|
|
21
|
|
|
|
21
|
|
Total
Non-Current Assets
|
|
|
72,074
|
|
|
|
69,856
|
|
|
|
|
|
|
|
|
|
|
Total
Assets
|
|
|
163,881
|
|
|
|
157,889
|
|
|
|
|
|
|
|
|
|
|
See
accompanying notes to unaudited condensed consolidated financial
statements.
EURAND
N.V.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In
thousands of euros, except share and per share amounts)
|
|
June
30,
2010
(Unaudited)
|
|
|
December
31, 2009
(Note
2)
|
|
|
|
|
|
LIABILITIES
AND SHAREHOLDERS’ EQUITY
|
|
|
|
|
|
|
Current
Liabilities
|
|
|
|
|
|
|
Current
portion of long-term debt from banks
|
|
|
1,000
|
|
|
|
-
|
|
Short-term
borrowings
|
|
|
-
|
|
|
|
207
|
|
Accounts
payable
|
|
|
8,353
|
|
|
|
12,628
|
|
Income
taxes payable
|
|
|
3,240
|
|
|
|
3,260
|
|
Accrued
expenses and other current liabilities
|
|
|
24,112
|
|
|
|
20,158
|
|
Total
Current Liabilities
|
|
|
36,705
|
|
|
|
36,253
|
|
|
|
|
|
|
|
|
|
|
Non-Current
Liabilities
|
|
|
|
|
|
|
|
|
Long-term
debt from banks
|
|
|
2,000
|
|
|
|
-
|
|
Employees
severance indemnities
|
|
|
3,864
|
|
|
|
3,932
|
|
Other
non-current liabilities
|
|
|
3,523
|
|
|
|
3,192
|
|
Deferred
income taxes
|
|
|
6,176
|
|
|
|
2,938
|
|
Total
Non-Current Liabilities
|
|
|
15,563
|
|
|
|
10,062
|
|
|
|
|
|
|
|
|
|
|
Commitments
and contingencies (Note 11)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Shareholders'
Equity
|
|
|
|
|
|
|
|
|
Ordinary
shares, par value €0.01 (130,000,000 shares authorized and 47,943,296 and
47,856,976 shares issued and outstanding as of June 30, 2010
and December 31, 2009, respectively)
|
|
|
479
|
|
|
|
479
|
|
Additional
paid-in capital
|
|
|
152,472
|
|
|
|
150,976
|
|
Accumulated
deficit
|
|
|
(47,299
|
)
|
|
|
(44,286
|
)
|
Accumulated
other comprehensive income
|
|
|
5,961
|
|
|
|
4,405
|
|
Total
Shareholders' Equity
|
|
|
111,613
|
|
|
|
111,574
|
|
Total
Liabilities and Shareholders' Equity
|
|
|
163,881
|
|
|
|
157,889
|
|
See
accompanying notes to unaudited condensed consolidated financial
statements.
EURAND
N.V.
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In
thousands of euros, except share and per share amounts)
|
|
For
the three months ended
|
|
|
For
the six months ended
|
|
|
|
June 30,
2010
|
|
|
June
30,
2009
|
|
|
June
30,
2010
|
|
|
June
30,
2009
|
Product
sales
|
|
|
29,441
|
|
|
|
24,095
|
|
|
|
56,287
|
|
|
|
48,098
|
|
Royalties
|
|
|
1,839
|
|
|
|
2,445
|
|
|
|
4,647
|
|
|
|
5,298
|
|
Development
fees
|
|
|
1,641
|
|
|
|
4,010
|
|
|
|
3,062
|
|
|
|
6,312
|
|
Revenues
|
|
|
32,921
|
|
|
|
30,550
|
|
|
|
63,996
|
|
|
|
59,708
|
|
Cost
of goods sold
|
|
|
(15,624
|
)
|
|
|
(15,565
|
)
|
|
|
(28,379
|
)
|
|
|
(29,810
|
)
|
Research
and development expenses attributable to development fees
|
|
|
(1,240
|
)
|
|
|
(2,211
|
)
|
|
|
(2,472
|
)
|
|
|
(3,823
|
)
|
Other
research and development expenses
|
|
|
(4,401
|
)
|
|
|
(3,173
|
)
|
|
|
(8,469
|
)
|
|
|
(7,900
|
)
|
Selling,
general and administrative costs
|
|
|
(14,168
|
)
|
|
|
(8,492
|
)
|
|
|
(25,096
|
)
|
|
|
(16,650
|
)
|
Amortization
of intangibles
|
|
|
(311
|
)
|
|
|
(347
|
)
|
|
|
(618
|
)
|
|
|
(702
|
)
|
Other
income (expenses)
|
|
|
35
|
|
|
|
-
|
|
|
|
(471
|
)
|
|
|
-
|
|
Operating
income (loss)
|
|
|
(2,788
|
)
|
|
|
762
|
|
|
|
(1,509
|
)
|
|
|
823
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income (expense), net
|
|
|
(12
|
)
|
|
|
75
|
|
|
|
5
|
|
|
|
128
|
|
Foreign
exchange gain (loss), net
|
|
|
-
|
|
|
|
(353
|
)
|
|
|
512
|
|
|
|
(297
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income
(loss) before taxes
|
|
|
(2,800
|
)
|
|
|
484
|
|
|
|
(992
|
)
|
|
|
654
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income
tax expense
|
|
|
(573
|
)
|
|
|
(1,086
|
)
|
|
|
(2,021
|
)
|
|
|
(2,230
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
|
(3,373
|
)
|
|
|
(602
|
)
|
|
|
(3,013
|
)
|
|
|
(1,576
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted net loss per share
|
|
|
(0.07
|
)
|
|
|
(0.01
|
)
|
|
|
(0.06
|
)
|
|
|
(0.03
|
)
|
Weighted
average shares used to compute basic and diluted net loss per
share
|
|
|
47,907,205
|
|
|
|
45,754,727
|
|
|
|
47,885,957
|
|
|
|
45,753,725
|
|
See
accompanying notes to unaudited condensed consolidated financial
statements.
EURAND
N.V.
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’
EQUITY
Six
months ended June 30, 2010 and 2009
(In
thousands of euros, except share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional
|
|
|
|
|
|
Other
|
|
|
Total
|
|
|
|
Common
Stock
|
|
|
Paid-In
|
|
|
Accumulated
|
|
|
Comprehensive
|
|
|
Shareholders'
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Deficit
|
|
|
Income
|
|
|
Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As
at December 31, 2008
|
|
|
45,751,997
|
|
|
|
458
|
|
|
|
134,643
|
|
|
|
(38,382
|
)
|
|
|
5,383
|
|
|
|
102,102
|
|
Comprehensive
loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,576
|
)
|
|
|
|
|
|
|
(1,576
|
)
|
Cumulative
exchange translation adjustment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(456
|
)
|
|
|
(456
|
)
|
Comprehensive
loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,032
|
)
|
Stock
option compensation
|
|
|
|
|
|
|
|
|
|
|
1,152
|
|
|
|
|
|
|
|
|
|
|
|
1,152
|
|
Exercise
of stock options
|
|
|
3,920
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-
|
|
As
at June 30, 2009
|
|
|
45,755,917
|
|
|
|
458
|
|
|
|
135,795
|
|
|
|
(39,958
|
)
|
|
|
4,927
|
|
|
|
101,222
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As
at December 31, 2009
|
|
|
47,856,976
|
|
|
|
479
|
|
|
|
150,976
|
|
|
|
(44,286
|
)
|
|
|
4,405
|
|
|
|
111,574
|
|
Comprehensive
loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,013
|
)
|
|
|
|
|
|
|
(3,013
|
)
|
Cumulative
exchange translation adjustment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,556
|
|
|
|
1,556
|
|
Comprehensive
loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,457
|
)
|
Stock
option compensation
|
|
|
|
|
|
|
|
|
|
|
1,397
|
|
|
|
|
|
|
|
|
|
|
|
1,397
|
|
Exercise
of stock options
|
|
|
86,320
|
|
|
|
-
|
|
|
|
99
|
|
|
|
|
|
|
|
|
|
|
|
99
|
|
As
at June 30, 2010
|
|
|
47,943,296
|
|
|
|
479
|
|
|
|
152,472
|
|
|
|
(47,299
|
)
|
|
|
5,961
|
|
|
|
111,613
|
|
See
accompanying notes to unaudited condensed consolidated financial
statements.
EURAND
N.V.
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In
thousands of euros)
|
|
For
the six months ended
|
|
|
|
June
30, 2010
|
|
|
June
30, 2009
|
|
Operating
Activities
|
|
|
|
|
|
|
Net
loss
|
|
|
(3,013
|
)
|
|
|
(1,576
|
)
|
Adjustments
to reconcile net loss to net cash provided by (used in) operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
3,048
|
|
|
|
3,511
|
|
Amortization
|
|
|
618
|
|
|
|
702
|
|
Unrealized
foreign exchange (gains) losses
|
|
|
(1,646
|
)
|
|
|
(58
|
)
|
Stock
compensation
|
|
|
1,397
|
|
|
|
1,152
|
|
Deferred
income taxes
|
|
|
1,085
|
|
|
|
21
|
|
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts
receivable, net
|
|
|
1,127
|
|
|
|
(4,526
|
)
|
Inventories,
net
|
|
|
(2,474
|
)
|
|
|
(1,359
|
)
|
Prepaid
expenses and other current assets
|
|
|
(430
|
)
|
|
|
(1,152
|
)
|
Other
non-current assets
|
|
|
-
|
|
|
|
(67
|
)
|
Accounts
payable
|
|
|
(4,744
|
)
|
|
|
(1,578
|
)
|
Accrued
expenses and other current liabilities
|
|
|
2,032
|
|
|
|
5,955
|
|
Other
non-current liabilities
|
|
|
(158
|
)
|
|
|
857
|
|
Income
taxes
|
|
|
(25
|
)
|
|
|
(970
|
)
|
Cash
provided by (used in) operating activities
|
|
|
(3,183
|
)
|
|
|
912
|
|
|
|
|
|
|
|
|
|
|
Investing
Activities
|
|
|
|
|
|
|
|
|
Purchase
of marketable securities
|
|
|
(5,276
|
)
|
|
|
(6,189
|
)
|
Maturity
of marketable securities
|
|
|
12,585
|
|
|
|
3,832
|
|
Losses
from hedging of marketable securities
|
|
|
(1,817
|
)
|
|
|
-
|
|
Purchases
of property, plant and equipment
|
|
|
(1,837
|
)
|
|
|
(2,258
|
)
|
Cash
provided by (used in) investing activities
|
|
|
3,655
|
|
|
|
(4,615
|
)
|
|
|
|
|
|
|
|
|
|
Financing
Activities
|
|
|
|
|
|
|
|
|
Net
changes in short term borrowings
|
|
|
(208
|
)
|
|
|
(72
|
)
|
Exercise
of stock options
|
|
|
99
|
|
|
|
-
|
|
Cash
received from long-term debt from banks
|
|
|
3,000
|
|
|
|
-
|
|
Cash
provided by (used in) financing activities
|
|
|
2,891
|
|
|
|
(72
|
)
|
Effect
of exchange rates on cash
|
|
|
464
|
|
|
|
(53
|
)
|
Increase
(decrease) in cash and cash equivalents
|
|
|
3,827
|
|
|
|
(3,828
|
)
|
Cash
and cash equivalents at beginning of period
|
|
|
16,893
|
|
|
|
19,146
|
|
Cash
and cash equivalents at end of period
|
|
|
20,720
|
|
|
|
15,318
|
|
See
accompanying notes to unaudited condensed consolidated financial
statements.
EURAND
N.V.
(In
thousands of euros, except share and per share data)
1. Company
Overview
Eurand
N.V. is a holding company formerly known as Eurand B.V., and before that, Eurand
Pharmaceuticals Holdings B.V., that was incorporated in The Netherlands as a
private company with limited liability in 1984 and converted into a Dutch public
limited liability company by notarial deed of conversion executed
November 30, 2006. In May 2007, Eurand N.V. completed an initial
public offering of its ordinary shares in the United States and its ordinary
shares began trading on the NASDAQ Global Market. Eurand N.V.’s
principal executive offices are located at Olympic Plaza, Fred. Roeskestraat
123, 1076 EE Amsterdam, The Netherlands, telephone +31 20-673 2744, with
operating subsidiaries organized in the United States, Italy, France and
Ireland.
Eurand
N.V. together with its subsidiaries (collectively the “Company”) is a specialty
pharmaceutical company that develops, manufactures and commercializes enhanced
pharmaceutical and biopharmaceutical products, utilizing proprietary
pharmaceutical technologies to develop novel products that it believes will have
advantages over existing products or will address unmet medical
needs. Through collaboration arrangements, the Company has applied
its technologies to drug products in a range of therapeutic areas, including
cardiovascular, gastrointestinal, pain, nutrition and
respiratory. The Company is developing and commercializing a
portfolio of therapeutic products to address conditions associated with cystic
fibrosis and gastrointestinal disorders and, which are being promoted in the
United States with the Company’s own sales and marketing team.
2. Basis
of Presentation
The
accompanying unaudited condensed consolidated financial statements as of and for
the three and six months ended June 30, 2010 and 2009, have been prepared in
accordance with United States generally accepted accounting principles (“U.S.
GAAP”) and Regulation S-X of the U.S. Securities and Exchange Commission
(“SEC”), consistently applied. The accompanying financial statements are
condensed, because certain information and footnote disclosures normally
included in annual financial statements have been condensed or omitted. In the
opinion of management, the accompanying unaudited condensed consolidated
financial statements contain all adjustments necessary to fairly present the
financial position, results of operations, changes in shareholders’ equity and
cash flows of the interim periods presented. All such adjustments are of a
normal recurring nature. The results of operations for any interim period are
not necessarily indicative of results for the full financial year. The
accompanying condensed consolidated financial statements should be read in
conjunction with the audited consolidated financial statements for the year
ended December 31, 2009. The accounting policies applied in preparing the
accompanying unaudited condensed consolidated financial statements are
consistent with those for the year ended December 31, 2009, except as
discussed in Adoption of Accounting Standards below.
The
preparation of the accompanying unaudited condensed consolidated financial
statements requires management to make estimates and assumptions that affect the
reported amounts of assets and liabilities and disclosure of contingent assets
and liabilities at the date of the financial statements and reported amounts of
revenues and expenses during the reporting periods. Actual results could differ
materially from those estimates.
Adoption
of Accounting Standards
In
January 2010, the FASB issued Accounting Standard Update
(“ASU”) 2010-06 for Fair Value Measurements and Disclosures (ASC
820): Improving Disclosures about Fair Value Measurements. This ASU
requires new disclosures for transfers in and out of Level 1 and 2 and activity
in Level 3; and also clarifies existing disclosures for level of disaggregation
and about inputs and valuation techniques. The changes to the ASC as a
result of this update were effective for interim and annual periods beginning
after December 15, 2009, except for the Level 3 disclosures, which are
effective for fiscal years beginning after December 15, 2010 and for
interim periods within those years; and the adoption did not have a material
impact on our consolidated financial statements. For Level 3 disclosures the
Company does not expect that new requirements will have a significant impact on
its consolidated financial statements.
EURAND
N.V.
NOTES TO
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(In
thousands of euros, except share and per share data)
Recent
Accounting Pronouncements
In
October 2009, the FASB issued ASU 2009-13, Multiple-Deliverable Revenue
Arrangements, which amends ASC 605, “Revenue Recognition.” ASU
2009-13 amends the ASC to eliminate the residual method of allocation for
multiple-deliverable revenue arrangements, and requires that arrangement
consideration be allocated at the inception of an arrangement to all
deliverables using the relative selling price method. The ASU also
establishes a selling price hierarchy for determining the selling price of a
deliverable, which includes: (1) vendor-specific objective evidence if
available, (2) third-party evidence if vendor-specific objective evidence is not
available, and (3) estimated selling price if neither vendor-specific nor
third-party evidence is available. Moreover, the ASU changes separability
criteria applied in identification of units of accounting, abolishing the
criterion that there must be objective and reliable evidence of fair value of
the undelivered item(s) for the delivered item to be a separate unit of
accounting. Additionally, ASU 2009-13 expands the disclosure requirements
related to a vendor's multiple-deliverable revenue arrangements. The changes to
the ASC as a result of this update are effective prospectively for revenue
arrangements entered into or materially modified in fiscal years beginning on or
after June 15, 2010 (January 1, 2011 for the Company). The changes to the ASC as
a result of this update also permit retrospective application for all periods
presented. The Company is currently evaluating the potential impact, if any, of
the adoption on its consolidated financial statements.
On 31
March 2010 FASB ratified Emerging Issues Task Force (“EITF”) Issue No. 08-9,
“Milestone Method of Revenue Recognition” (Issue 08-9). The ASU resulting from
Issue 08-9 amends ASC 605-28. The Task Force concluded that the milestone method
is a valid application of the proportional performance model when applied to
research or development arrangements. Accordingly, the consensus states that an
entity can make an accounting policy election to recognize a payment that is
contingent upon the achievement of a substantive milestone in its entirety in
the period in which the milestone is achieved. The milestone method is not
required and is not the only acceptable method of revenue recognition for
milestone payments. The guidance in Issue 08-9 is effective for fiscal years,
and interim periods within those years, beginning on or after 15 June 2010
(January 1, 2011 for the Company), and may be applied prospectively to
milestones achieved after the adoption date or retrospectively for all periods
presented. Early adoption is permitted provided that the revised guidance is
retrospectively applied to the beginning of the year of adoption. The Company
has elected not to adopt the ASU before January 1, 2011. The Company does not
expect that the adoption of the ASU will have a significant impact on the
consolidated financial statements of the Company.
The
carrying amounts of cash and cash equivalents, net accounts receivable, net
accounts payable, short term borrowings and long term debt from banks
approximate their fair values as of June 30, 2010 and December 31,
2009.
As of
June 30, 2010 and December 31, 2009 the Company held U.S. treasury bills and
French government bonds; and U.S. treasury bills, German and French government
bonds, respectively, classified as “held to maturity.” Held to maturity
investments are recorded at cost, adjusted for amortization of premiums and
discounts.
|
|
June
30, 2010 (unaudited)
|
|
|
December
31, 2009 (note 2)
|
|
|
|
Carrying
value
|
|
|
Fair
value measured at prices quoted in active markets for identical assets
(Level 1)
|
|
|
Carrying
value
|
|
|
Fair
value measured at prices quoted in active markets for identical assets
(Level 1)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Marketable
securities
|
|
|
17,572
|
|
|
|
17,559
|
|
|
|
23,049
|
|
|
|
23,013
|
|
For
marketable securities, pricing inputs are readily observable in the market, the
valuation methodology used is widely accepted by market participants, and the
valuation does not require significant management discretion. Level 1
inputs include quoted prices for identical instruments and are
observable.
Marketable
securities held as of June 30, 2010 and December 31, 2009 all had contractual
maturities within one year of the reporting dates.
4.
Derivatives
The
Company enters into forward exchange contracts to hedge receivables and payables
denominated in U.S. dollars and Swiss francs. These contracts do not meet
the criteria for formal designation and documentation at hedge inception and,
accordingly, they are adjusted to fair value through income. Any respective
assets or liabilities resulting from the fair value valuation of forward
exchange contracts are disclosed as other current assets and other current
liabilities, respectively, and were immaterial as of June 30, 2010 and
December 31, 2009. The notional amounts of the forward exchange contracts
to sell U.S. dollars were $18,782,000 and $29,723,000 as of June 30,
2010 and December 31, 2009, respectively. The notional amounts of the
forward exchange contracts to buy Swiss francs were CHF 3,665,000 and CHF
3,776,000 as of June 30, 2010 and December 31, 2009, respectively.
During the three months ended June 30, 2010 and 2009, the Company
recognized foreign exchange gains (losses) of €(3,687) and €176, respectively,
within foreign exchange gain (loss), net, in the unaudited consolidated
statement of operations, related to these hedging activities. During the six
months ended June 30, 2010 and 2009, the Company recognized foreign exchange
losses of €5,214 and €218, respectively, within foreign exchange gain (loss),
net, in the unaudited consolidated statement of operations, related to these
hedging activities.
5. Inventories,
net
|
|
June
30,
2010
(unaudited)
|
|
|
December
31,
2009
(note
2)
|
|
|
|
|
|
|
|
|
Raw
materials
|
|
|
10,677
|
|
|
|
9,759
|
|
Work
in progress
|
|
|
3,390
|
|
|
|
3,174
|
|
Finished
goods
|
|
|
5,427
|
|
|
|
2,700
|
|
|
|
|
19,494
|
|
|
|
15,633
|
|
Allowances
for obsolescence of inventories were €1,750 and €1,681 as of June 30, 2010 and
December 31, 2009, respectively.
EURAND
N.V.
NOTES TO
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(In
thousands of euros, except share and per share data)
6. Prepaid
Expenses and Other Current Assets
|
|
June
30,
2010
(unaudited)
|
|
|
December
31,
2009
(note
2)
|
|
|
|
|
|
|
|
|
Litigation
settlement receivable – current portion
|
|
|
4,303
|
|
|
|
3,646
|
|
Prepayments
|
|
|
3,917
|
|
|
|
2,135
|
|
Recoverable
amounts for income taxes
|
|
|
1,670
|
|
|
|
1,649
|
|
Recoverable
amounts for other taxes
|
|
|
387
|
|
|
|
1,053
|
|
Deferred
cost of goods sold
|
|
|
249
|
|
|
|
558
|
|
|
|
|
10,526
|
|
|
|
9,041
|
|
7. Income
Taxes
The major
reconciling items between the income taxes computed at the Dutch statutory tax
rate of 25.5% and the effective tax rate for the three and six months ended June
30, 2010 and 2009 are the increase in the valuation allowance recorded on net
operating losses (“NOLs”) incurred by certain of our subsidiaries and the effect
of Imposta Regionale sulle Attività Produttive (“IRAP tax”) in
Italy.
The IRAP
tax is an Italian regional tax on productive activities, and has a statutory
rate of 3.9%. The IRAP tax base is similar to the corporate tax base, however
deduction of interest and most labor costs is not permitted. The IRAP tax is not
deductible for corporate tax purposes.
8. Accrued
Expenses and Other Current Liabilities
|
|
June
30,
2010
(unaudited)
|
|
|
December
31,
2009
(note
2)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accrued
employee compensation
|
|
|
6,194
|
|
|
|
5,436
|
|
Accrued
expenses
|
|
|
3,782
|
|
|
|
3,448
|
|
Accrued
product returns
|
|
|
2,451
|
|
|
|
3,595
|
|
Accrued
rebates and chargebacks
|
|
|
2,352
|
|
|
|
940
|
|
Social
security and other contributions
|
|
|
1,408
|
|
|
|
1,523
|
|
Taxes,
other than income taxes
|
|
|
836
|
|
|
|
898
|
|
Deferred
revenues
|
|
|
7,089
|
|
|
|
4,318
|
|
|
|
|
24,112
|
|
|
|
20,158
|
|
EURAND
N.V.
NOTES TO
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(In
thousands of euros, except share and per share data)
9. Long-Term
Debt from Banks
On June
16, 2010 the Company entered into an unsecured loan agreement with an Italian
bank to borrow €3,000 repayable in installments from September 2010 through
September 2013 with a variable interest of 1.6% above Euribor. Euribor interest
rate is hedged by a cap of 2.5%.
Long-term
debt from banks is as follows:
|
|
June
30,
2010
(unaudited)
|
|
|
December
31,
2009
(note
2)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loan
from Italian bank
|
|
|
3,000
|
|
|
|
-
|
|
|
|
|
3,000
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Amount
due within one year
|
|
|
(1,000
|
)
|
|
|
-
|
|
|
|
|
2,000
|
|
|
|
-
|
|
10. Shareholders’
Equity
Share
Capital
During
the six months ended June 30, 2010 and 2009, the Company issued 86,320 and 3,920
ordinary shares, respectively, in order to satisfy our obligations on the
exercise of employee stock options.
Equity
Based Compensation
Certain
of our employees participate in the Eurand N.V. Equity Compensation Plan (the
“Plan”) for which a maximum of 12,235,224 ordinary shares have been authorized
for grants of options and other share awards by us. The Plan is an amendment and
restatement of the Eurand N.V. Equity Compensation Plan adopted on
August 29, 2007, which in turn was an amendment and restatement of the
Eurand N.V. 1999 Stock Option Plan first adopted in December 1999.
The
criteria for measurement of option value, and consequently the commencement of
the amortization of the expense, were met for 870,250 and 254,000 options,
respectively, during the six months ended June 30, 2010 and 2009.
11. Commitments
and Contingencies
We are
involved in legal proceedings arising in the normal course of business.
Management believes that, based on advice of legal counsel and currently
available information, the outcome of these proceedings will not have a material
adverse effect on our consolidated financial statements.
EURAND
N.V.
(In
thousands of euros, except share and per share data)
12. Per
Share Information
In
accordance with ASC Topic 260, “Earnings per Share,” the Company has reported
both basic and diluted net loss per share. The computation of diluted net loss
per share did not assume the effect of shares issuable upon the exercise of
stock options as their effects are anti-dilutive. Averages of non-dilutive stock
options are as follows:
|
|
For
the three months ended
|
|
For
the six months ended
|
|
|
|
June
30, 2009
(unaudited)
|
|
|
June
30, 2009
(unaudited)
|
|
|
June
30, 2010
(unaudited)
|
|
|
June
30, 2009
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average
of non-dilutive stock options
|
|
|
4,522,136
|
|
|
|
3,840,096
|
|
|
|
4,205,679
|
|
|
|
3,852,356
|
|
13. Geographic
Revenues
Revenues
based on the country in which the recipient of the product or service is
resident, are as follows:
|
|
For
the three months ended
|
|
|
For
the six months ended
|
|
|
|
June 30,
2010 (unaudited)
|
|
|
June
30, 2009 (unaudited)
|
|
|
June
30, 2010 (unaudited)
|
|
|
June
30, 2009 (unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.A
|
|
|
23,151
|
|
|
|
16,814
|
|
|
|
43,542
|
|
|
|
32,894
|
|
Germany
|
|
|
2,709
|
|
|
|
3,062
|
|
|
|
6,496
|
|
|
|
6,040
|
|
United
Kingdom
|
|
|
1,708
|
|
|
|
2,382
|
|
|
|
3,841
|
|
|
|
4,827
|
|
Japan
|
|
|
1,074
|
|
|
|
1,394
|
|
|
|
1,893
|
|
|
|
2,527
|
|
Italy
|
|
|
943
|
|
|
|
1,269
|
|
|
|
1,592
|
|
|
|
2,686
|
|
Spain
|
|
|
329
|
|
|
|
1,037
|
|
|
|
779
|
|
|
|
1,459
|
|
Switzerland
|
|
|
1,253
|
|
|
|
915
|
|
|
|
1,271
|
|
|
|
2,262
|
|
Canada
|
|
|
308
|
|
|
|
804
|
|
|
|
703
|
|
|
|
1,206
|
|
France
|
|
|
553
|
|
|
|
545
|
|
|
|
1,006
|
|
|
|
1,461
|
|
Netherlands
|
|
|
34
|
|
|
|
471
|
|
|
|
474
|
|
|
|
1,080
|
|
Other
|
|
|
859
|
|
|
|
1,857
|
|
|
|
2,399
|
|
|
|
3,266
|
|
|
|
|
32,921
|
|
|
|
30,550
|
|
|
|
63,996
|
|
|
|
59,708
|
|
OPERATING
AND FINANCIAL REVIEW AND PROSPECTS
You
should read the following discussion and analysis in conjunction with our
unaudited condensed consolidated financial statements and the related notes to
our unaudited condensed consolidated financial statements and the other
financial information appearing elsewhere in this report. Except for
historical information contained herein, this discussion contains
forward-looking statements that involve risks and uncertainties. Our actual
results could differ materially from the results discussed below. Accordingly,
investors should not place undue reliance upon our forward-looking
statements.
Forward Looking
Statements
The
forward-looking statements are contained primarily in the section entitled
“Operating and Financial Review and Prospects”. All statements in this document
that are not statements of historical fact are forward looking statements as
defined in Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended. In some
cases, you can identify forward-looking statements by terms including
“anticipates,” “believes,” “could,” “estimates,” “expects,” “intends,” “may,”
“plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would,” and
similar expressions intended to 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. In addition to the risks and uncertainties included in this Report
on Form 6-K, other factors that could cause our actual results or actual
outcomes to differ materially from those expressed in or implied by such
forward-looking statements include, but are not limited to:
·
|
our
ability to market, commercialize and achieve market acceptance for
ZENPEP
®
or any of the products that we are developing, commercializing or may
develop or commercialize in the future, including the growth and
establishment of specialty sales, marketing and distribution capabilities
in the United States to commercialize
products;
|
·
|
the
possibility that our competitors have introduced significant quantities of
unapproved products into the market place prior to the FDA’s April 28
th
,
2010 Stop Distribution date and that, for a period of time, this excess
inventory will compete with sales of our approved product,
ZENPEP;
|
·
|
the
uncertainty surrounding the timing of the U.S. Food and Drug
Administration’s (FDA) approval for Axcan’s ULTRASE® MT. The
Company licenses, manufactures and supplies Ultrase capsules to Axcan and
there is possibility that we may have significantly reduced PEP sales to
this customer in the United States until such approval is obtained, as
well as subsequent competition in the event that the product is
approved;
|
·
|
the
expected timing, costs, progress or success of any of our preclinical and
clinical development programs, regulatory approvals, or commercialization
efforts;
|
·
|
delays
in obtaining, or a failure to obtain and maintain, regulatory approval for
our product candidates;
|
·
|
our
ability to continue to successfully manufacture our existing
products;
|
·
|
the
potential advantages of our products or product candidates over other
existing or potential products;
|
·
|
our
ability to enter into any new co-development or licensing agreements or to
maintain any existing co-development or licensing agreements with respect
to our product candidates or
products;
|
·
|
our
ability to effectively maintain existing licensing relationships and
establish new licensing
relationships;
|
·
|
the
expense, time and uncertainty involved in the development of our product
candidates, some or all of which may never reach the regulatory approval
stage;
|
·
|
our
reliance on collaboration partners and licensees, to obtain and maintain
regulatory approval for certain of our products and product candidates,
and to commercialize such products;
|
·
|
our
ability to compete in the pharmaceutical
industry;
|
·
|
our
ability to protect our intellectual property and know-how and operate our
business without infringing the intellectual property rights or regulatory
exclusivity of others;
|
·
|
the
continuation of product sales by our collaborators and
licensees;
|
·
|
a
loss of rights to develop and commercialize our products under our license
and sublicense agreements;
|
·
|
a
loss of any of our key scientists or management
personnel;
|
·
|
our
estimates of market sizes and anticipated uses of our products and product
candidates;
|
·
|
our
estimates, and the estimates of others, including equity research
analysts, of our future
performance;
|
·
|
and
our estimates, and the estimates of others, including equity research
analysts, regarding our anticipated future revenue, expenses, operating
losses, capital requirements and our needs for additional
financing.
|
Business Update
Marketed
Product Updates
EUR-1008
– ZENPEP
®
(pancrelipase) Delayed-Release Capsules
FDA-approved
ZENPEP is a proprietary porcine-derived pancreatic enzyme replacement product,
or PEP, developed to address the 2004 FDA guidance on pancreatic enzyme products
(PEPs). It has been approved for the treatment of (exocrine
pancreatic insufficiency) EPI due to cystic fibrosis (CF) or other
conditions. Patients suffering from EPI are unable to produce or
secrete pancreatic enzymes necessary for digestion, resulting in the
malabsorption of nutrients and overall malnutrition. EPI patients
typically require PEPs which break down fats, proteins and complex carbohydrates
for proper absorption into the body. PEPs are a daily requirement for
patients with EPI and are considered necessary for survival of many patients
with CF. According to data from IMS Health, PEPs generated
approximately $1.3 billion in worldwide sales and approximately
$403 million in U.S. sales in 2009.
PEPs had
been commercialized in the U.S. without the benefit of FDA approval for more
than 70 years. In 2004, after significant adverse event reports, the
FDA conducted a review of PEPs and found that none demonstrated “consistent
bioactivity that results in predictable safety and effectiveness,” primarily as
a result of lack of product stability and overfill. As a result of
these findings, the FDA mandated that all PEPs be subject to FDA review and
approval and established criteria to ensure consistent quality, potency and
stability of PEPs. The FDA initially allowed certain manufacturers to
continue to manufacture and sell unapproved PEPs until April 28,
2008. However, in October 2007 the FDA extended the deadline to April
28, 2010.
We
launched ZENPEP
®
(pancrelipase) Delayed-Release Capsules, a treatment for pancreatic
insufficiency, in November 2009. In mid-December 2009, we introduced
PANCRELIPASE™, an authorized generic (AG) to the 5000 unit dose of
ZENPEP. The AG is intended to retain the market share which the
unbranded Pancrelipase captured in 2009 in the low-dose segment of the
gastroenterology market. This market has historically has moved to the
lowest-cost product.
In
addition to receiving five years of regulatory exclusivity as a new chemical
entity (NCE), we have filed a number of patent applications that include claims
intended to provide market exclusivity for certain commercial aspects of
ZENPEP. On February 9, 2010, the U.S. Patent and Trademark Office
issued U.S. Patent No. 7,658,918, entitled "STABLE DIGESTIVE ENZYME
COMPOSITIONS". We expect that this patent will provide us with patent
coverage on ZENPEP until at least February 20, 2028.
We are
marketing ZENPEP to the approximately 120 CF Centers across the U.S. through our
own sales force of 16 sales representatives and to the gastrointestinal market
segment primarily through a contract sales organization of 49 sales
representatives.
Based on
publicly available materials and our industry knowledge, we are aware of two
other PEP manufacturers that filed and have pending NDAs for a PEP and two
(Solvay/Abbott and Johnson & Johnson) who have received FDA approval. In
2009 two PEPs received FDA approval, Creon
®
from
Solvay/Abbott and ZENPEP. In April 2010 McNeil Consumer Healthcare, a
subsidiary of Johnson & Johnson, announced FDA approval for Pancreaze™, its
reformulated PEP, formerly marketed as Pancrease.
ZENPEP
Launch Update
For the
week ended July 23, 2010, our total ZENPEP franchise (ZENPEP and the AG) held
15% of total prescriptions in the PEP market. This represents an
increase of 9 points or 150% when compared with a 6% share of total
prescriptions as of April 23, 2010.
In late
March 2010, the FDA, in accordance with its previously stated guidance that all
marketed PEPs were required to have FDA approval by April 28, 2010, declared
this a Stop Distribution date for unapproved PEPs and advised that patients not
currently taking an approved product begin working with their healthcare
professionals to switch to an FDA-approved PEP. On April 29, 2010, the Centers
for Medicare & Medicaid Services (CMS) announced that, effective
immediately, certain unapproved PEPs would no longer be reimbursed.
On May 6,
2010, Axcan announced that the FDA issued a complete response letter regarding
Axcan’s New Drug Application (NDA) for its coated PEP, ULTRASE
®
MT. This letter requires that deficiencies with respect to the
manufacturing and control processes at the manufacturer of the active ingredient
of ULTRASE
®
MT be
addressed before approval can be granted (Eurand is not the manufacturer of the
active ingredient). The FDA has not requested any new clinical
studies. Axcan has stated publicly that they are working closely with
the FDA to address outstanding questions and are confident that ULTRASE
®
MT
will receive NDA approval, but cannot give any guidance at this point as to when
approval will occur.
In
accordance with the FDA's guidance, Axcan has stated that they stopped
distribution of Ultrase effective April 28, 2010. We license, manufacture
and supply Ultrase capsules to Axcan and also receive royalties based on a
percentage of Axcan’s net sales of the finished product. Both in 2009 and in the
three months ended March 31, 2010, revenues from product sales and royalties to
Axcan in the United States accounted for 31% of our total
revenues. In the second quarter of 2010 our revenues from Ultrase
decreased substantially compared with the second quarter of 2009 and the first
quarter of 2010, and accounted for 19% of our total
revenues. However, sales of ZENPEP in the second quarter 2010 more
than offset lower product sales and royalties from Axcan for Ultrase, compared
with the second quarter of 2009.
The
ULTRASE
®
MT
product, if approved, would compete with ZENPEP. As there are
currently only three approved products for the PEP market (ZENPEP, Creon
®
by
Solvay/Abbott and Pancreaze™ by Johnson & Johnson) as long as Axcan's
ULTRASE
®
MT
and VIOKASE
®
products remain unapproved, an opportunity is
presented for ZENPEP, or the other approved PEPs, to capture an additional share
of the PEP market. Pending FDA approval and launch, we anticipate
lower product sales and royalties from Axcan for Ultrase in the second half of
2010 compared with the first half, but we expect that, compared with the second
half of 2009, the revenue decrease due to Ultrase should be more than offset by
increasing ZENPEP franchise revenues.
Product
Development Pipeline Updates
EUR-1008
– ZENPEP
®
(pancrelipase) Delayed-Release Capsules
In late
2009, the European Medicines Agency (EMA) finalized its draft guidelines on the
clinical development and evaluation of medicinal products, including PEPs, for
the treatment of cystic fibrosis. Based on these guidelines and the
feedback we received from the EMA on the clinical and regulatory path forward
for EUR-1008 (ZENPEP), we anticipate initiating a Phase III study in Europe in
the second half of 2010.
The EMA
has deemed a ZENPEP marketing authorization application eligible for evaluation
of the under the Centralized Procedure, which enables a single marketing
authorization that is valid across the European Union and provides the potential
for 10 years of marketing exclusivity once the product is
approved. We believe that ZENPEP could be the first product to be
filed under the Centralized Procedure since the EMA guidelines were
issued.
We intend
to out-license the distribution rights for EUR-1008 in Europe and Asia and
discussions are ongoing with potential partners in those regions.
EUR-1025
– Once-Daily Formulation of Ondansetron
Following
a meeting with the FDA in late 2009, we submitted a protocol to the FDA for two
Phase III studies evaluating EUR-1025, a proprietary once-a-day oral
modified-release formulation of ondansetron, in the prevention of nausea and
vomiting. The FDA recently provided its response, and Eurand is
incorporating this feedback into the protocol design.
EUR-1073
– CLIPPER™ (beclomethasone dipropionate)
Chiesi
Farmaceutici S.p.A., the licensor of EUR-1073, a corticosteroid for the
treatment
of ulcerative colitis, completed a Phase IIIb clinical study in Europe
comparing
CLIPPER™ to the current standard of care, prednisolone, in ulcerative
colitis.
Following a thorough analysis of the data from this study, Eurand has
decided
to discontinue development of this product and return the rights to Chiesi at
no cost
to Eurand.
Presentation of Financial
information
We
prepared our financial statements included in this report in euros in accordance
with U.S. GAAP. References to “U.S. dollars,” “dollars,” “U.S. $” or “$” in this
report are to the currency of the United States and references to “euro”,
“(euro)” or “€“ are to the single currency of the European Union.
Exchange
Rate Information
Fluctuations
in the exchange rates between the euro and the dollar will affect the dollar
amounts received by owners of our shares on payment of dividends, if any, paid
in euros. Moreover, such fluctuations may also affect the dollar price of our
shares on the NASDAQ Global Market.
The
following table sets forth information regarding the exchange rates of U.S.
dollar per euro for the periods indicated. Average rates are calculated by using
the average of the closing noon buying rates on each day during the periods
presented.
|
|
High
|
|
|
Low
|
|
|
Average
|
|
|
Period
End
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three
months ended
|
|
|
|
|
|
|
|
|
|
|
|
|
March
31, 2009
|
|
|
1.3946
|
|
|
|
1.2547
|
|
|
|
1.3035
|
|
|
|
1.3261
|
|
June 30,
2009
|
|
|
1.4270
|
|
|
|
1.2903
|
|
|
|
1.3619
|
|
|
|
1.4020
|
|
September 30,
2009
|
|
|
1.4795
|
|
|
|
1.3852
|
|
|
|
1.4311
|
|
|
|
1.4630
|
|
December
31, 2009
|
|
|
1.5100
|
|
|
|
1.4243
|
|
|
|
1.4762
|
|
|
|
1.4332
|
|
March
31, 2010
|
|
|
1.4536
|
|
|
|
1.3344
|
|
|
|
1.3820
|
|
|
|
1.3526
|
|
June
30, 2010
|
|
|
1.3666
|
|
|
|
1.1959
|
|
|
|
1.2740
|
|
|
|
1.2291
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six months ended June 30,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
1.4270
|
|
|
|
1.2547
|
|
|
|
1.3334
|
|
|
|
1.4020
|
|
2010
|
|
|
1.4536
|
|
|
|
1.1959
|
|
|
|
1.3267
|
|
|
|
1.2291
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Month
in 2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
January
|
|
|
1.4536
|
|
|
|
1.3870
|
|
|
|
1.4266
|
|
|
|
1.3870
|
|
February
|
|
|
1.3955
|
|
|
|
1.3476
|
|
|
|
1.3675
|
|
|
|
1.3660
|
|
March
|
|
|
1.3758
|
|
|
|
1.3344
|
|
|
|
1.3570
|
|
|
|
1.3526
|
|
April
|
|
|
1.3666
|
|
|
|
1.3130
|
|
|
|
1.3417
|
|
|
|
1.3302
|
|
May
|
|
|
1.3183
|
|
|
|
1.2224
|
|
|
|
1.2563
|
|
|
|
1.2369
|
|
June
|
|
|
1.2385
|
|
|
|
1.1959
|
|
|
|
1.2223
|
|
|
|
1.2291
|
|
July
|
|
|
1.3069
|
|
|
|
1.2464
|
|
|
|
1.2811
|
|
|
|
1.3069
|
|
Results of
Operations
This
section discusses our operating results.
Three
months ended June 30, 2010, compared to three months ended June 30,
2009
The
following table shows how revenues for the three months ended June 30, 2010
changed compared to the same period in 2009.
|
|
Three
months ended June 30,
|
|
|
|
2010
|
|
|
2009
|
|
|
Increase
(decrease) compared to previous period
|
|
|
|
(euros
in thousands, except percentages)
|
|
Product
sales
|
|
|
29,441
|
|
|
|
24,095
|
|
|
|
5,346
|
|
|
|
22
|
%
|
Royalty
income
|
|
|
1,839
|
|
|
|
2,445
|
|
|
|
(606
|
)
|
|
|
-25
|
%
|
Development
fees
|
|
|
1,641
|
|
|
|
4,010
|
|
|
|
(2,369
|
)
|
|
|
-59
|
%
|
Total
revenues
|
|
|
32,921
|
|
|
|
30,550
|
|
|
|
2,371
|
|
|
|
8
|
%
|
Revenues.
Our total revenues
were
€32.9
million
for the three months ended June 30, 2010, compared to
€30.6
million
for the same period in 2009, an increase of
€2.4
million
or approximately 8%. The increase was primarily due to sales of ZENPEP and its
AG (Authorized Generic), Pancrelipase
TM
,
which we sell in the U.S. market and were launched at the end of 2009. This
growth would have been 0.9 million, approximately 3%, if we excluded the effect
of currency exchange rates variances.
Our
product sales were
€29.4
million
for the three months ended June 30, 2010, an increase of
€5.3
million
or approximately 22% compared to the same period in 2009. The
increase was due to sales of ZENPEP which more than offset lower sales of
ULTRASE to Axcan and no revenues from our low cost pancrelipase product which
generated significant sales in 2009. The increase in product sales growth would
have been
€4.1
million
or approximately 17% if currency effects worth
€1.2
million
were excluded.
Our
royalties were
€1.8
million
for the three months ended June 30, 2010, a decrease of
€0.6
million
or approximately 25%, due to a decrease in royalties from ULTRASE of
Axcan. This decrease would have been
€
0.7 million or 29%
if the currency effects were excluded. Pending FDA approval and launch, we
anticipate substantially lower product royalties from ULTRASE of Axcan in the
subsequent periods.
Our
development fees were
€1.6
million for
the three months ended June 30, 2010 compared to
€4.0
million
for the same period in 2009, a decrease of
€2.4
million,
or approximately 59%. If the currency exchange rate effect were
excluded the decrease would have been 62% or
€2.5
million. Development
fees may fluctuate significantly from quarter to quarter depending on when
certain milestone fees are earned and during the same period of 2009 included
milestone revenue from GSK related to the launch of LAMICTAL ODT.
Cost of Goods Sold.
Our cost
of goods sold was
€15.6
million
for the three months ended June 30, 2010 compared to
€15.6
million
for the same period in 2009. If negative foreign exchange effects of
approximately
€0.6
million
were excluded, cost of goods sold would have decreased by
€0.6
million
or approximately 4% compared to the previous year. During the second quarter of
2010 we sold some inventories of ZENPEP that had been expensed in previous
periods before in the third quarter of 2009 we received a regulatory approval
for commercial launch in the U.S. If the related inventories were not expensed
in previous periods cost of goods sold in the three months ended June 30, 2010
would have been higher by approximately €0.4 million.
Cost of
goods sold as a percentage of product sales was 53.1% compared to 64.6% in the
same period of 2009 and is primarily the result of the increase in higher margin
ZENPEP product sales.
Research and Development Expenses.
Research and development expenses were
€5.6
million
for the three months ended June 30, 2010 compared to
€5
.4 million
for the same period in 2009, representing an increase of
€0.3
million,
or approximately 5%. If foreign exchange rate effects were excluded,
total R&D expense would have increased by
€0
.1 million,
approximately 1%. We classify our research and development expenses
into two categories, research and development expenses attributable to
development fees and other research and development expenses.
Research and Development Expenses
Attributable to Development Fees
. For the three months ended June 30,
2010, we were involved in a number of external projects for third parties, which
we classify in our consolidated statement of operations as research and
development expenses attributable to development fees. For the three months
ended June 30, 2010, we incurred €1.2 million in research and development
expenses attributable to development fees, representing 22% of our total
research and development expenses. This represented a decrease of €1.0 million
compared to the same period in 2009. The largest component of these research and
development expenses attributable to development fees was personnel costs. For
the three months ended June 30, 2010, €0.6 million of personnel costs were
incurred compared to €0.7 million for the same period in 2009. With more than 10
active external projects during the three months ended June 30, 2010 and 2009,
no single project was individually significant.
Other Research and Development
Expenses.
In our consolidated statement of operations, we refer to
internal research and development expenses as other research and development
expenses. For the three months ended June 30, 2010, we incurred €4.4 million in
other research and development expenses, representing 78% of our total research
and development expenses. This represented an increase of €1.2 million compared
to the same period in 2009. Certain components of our other research and
development expenses, notably clinical study activity, can
significantly
vary from quarter to quarter. Both for the three months ended June 30, 2010 and
2009, the only internal project that was individually significant with respect
to our total research and development expenses was ZENPEP® (EUR-1008). In the
three months ended June 30, 2010 development costs for EUR-1008 were €1.7
million and €1.5 million in the same period in 2009. For the three months ended
June 30, 2010 and 2009, the portion of our research and development
expenses attributable to other internal development projects was €2.7 million
and €1.7 million, respectively, and was comprised of multiple projects, none of
which was individually significant in relation to our total research and
development expenses.
Selling, General and Administrative
Expenses.
Selling, general and administrative expenses were
€14.2
million for
the three months ended June 30, 2010 compared to
€8.5
million
for the same period in 2009, representing an increase of
€5.7 million,
ap
proximately 67% or
€4.9
million,
approximately 58% if the currency effects were excluded. This is
primarily attributable to an increase in direct sales and marketing expenses
associated with the launch of ZENPEP, the expansion of the sales force, and
related marketing, patient support and managed care programs.
Income tax expense.
For the
three months ended June 30, 2010, we recorded income taxes of
€573
thousand on a
pre-tax loss of
€2.8
million
. In the three months ended June 30, 2009, we
recorded income taxes of approximately
€1
.1 million
on a pre-tax income of
€484
thousand
. Our taxes do not correlate directly to our
consolidated profit and loss before tax for two main reasons. First,
we are subject to certain local income taxes in Italy for which most labor and
financial costs are non-deductible. Second, we have recorded
valuation allowances to reduce deferred tax assets and withholding taxes
recoverable in certain operating subsidiaries that are not generating taxable
profits on a recurring basis to amounts that are deemed more likely than not to
be recovered. Additionally in the second quarter 2010, due to revisions to our
estimates of revenues from product sales and royalties from ULTRASE of Axcan, we
revised and increased our estimated annual effective tax rate applied to the
income of our Italian subsidiary. The effect of this revision, which was applied
to income before taxes for the first half of 2010, was fully recorded in income
tax expense in the second quarter of 2010.
Six
months ended June 30, 2010, compared to six months ended June 30,
2009
The
following table shows how revenues for the six months ended June 30, 2010
changed compared to the same period in 2009.
|
|
Six
months ended June 30,
|
|
|
|
2010
|
|
|
2009
|
|
|
Increase
(decrease) compared to previous period
|
|
|
|
(euros
in thousands, except percentages)
|
|
Product
sales
|
|
|
56,287
|
|
|
|
48,098
|
|
|
|
8,189
|
|
|
|
17
|
%
|
Royalty
income
|
|
|
4,647
|
|
|
|
5,298
|
|
|
|
(651
|
)
|
|
|
-12
|
%
|
Development
fees
|
|
|
3,062
|
|
|
|
6,312
|
|
|
|
(3,250
|
)
|
|
|
-52
|
%
|
Total
revenues
|
|
|
63,996
|
|
|
|
59,708
|
|
|
|
4,288
|
|
|
|
7
|
%
|
Revenues.
Our total revenues
were
€64
.0 million
for the six months ended June 30, 2010, compared to
€59.7
million
for the same period in 2009, an increase of
€4.3
million
or approximately 7%. The increase was primarily due to sales of ZENPEP and its
AG (Authorized Generic), Pancrelipase
TM
,
which we sell in the U.S. market and were launched at the end of 2009. This
growth was not affected by changes in exchange rates.
Our
royalties were
€4.6
million
for the six months ended June 30, 2010, a decrease of
€0.7
million
or approximately 12%, due to a decrease in royalties from ULTRASE of Axcan. This
decrease would have been
€
0.6 million or 11%
if the currency effects were excluded. Pending FDA approval and launch, we
anticipate substantially lower product royalties from ULTRASE of Axcan in the
subsequent periods.
Our
development fees were
€3.1
million for
the six months ended June 30, 2010 compared to
€6.3
million
for the same period in 2009, a decrease of
€3.2
million,
or approximately 52%. The currency exchange rate had no significant
impact on the development fees. Development fees may fluctuate significantly
from quarter to quarter depending on when certain milestone fees are earned and
for the first six months of 2009 included a milestone payment from GSK related
to the launch of LAMICTAL ODT.
Cost of Goods Sold.
Our cost
of goods sold was
€
28.4 million
for the six months ended June 30, 2010 compared to
€
29.8 million
for the same period in 2009, representing a decrease of
€1.4
million,
or approximately 5%. If foreign exchange effects of approximately
€0.3
million
were excluded then the decrease would have been approximately
€1
.7 million
or 6%, compared to the previous year. During the first half of 2010 we sold some
inventories of ZENPEP that were expensed in previous periods before in the third
quarter of 2009 we received a regulatory approval for commercial launch in the
U.S. If the related inventories were not expensed in previous periods cost of
goods sold in the six months ended June 30, 2010 would have been higher by
approximately €0.5 million.
Cost of
goods sold as a percentage of product sales was 50.4% compared to 62.0% in the
same period of 2009 primarily as result of the increase in higher margin ZENPEP
product sales.
Research and Development Expenses.
Research and development expenses were
€
10.9 million
for the six months ended June 30, 2010 compared to
€11
.7 million
for the same period in 2009, representing a decrease of
€0.8
million,
or approximately 7%. Foreign exchange rate effects have not had any
significant impact and would show the same decrease if the currency effects were
excluded. We classify our research and development expenses into two
categories, research and development expenses attributable to development fees
and other research and development expenses.
Research and Development Expenses
Attributable to Development Fees
. For the six months ended June 30, 2010,
we were involved in a number of external projects for third parties, which we
classify in our consolidated statement of operations as research and development
expenses attributable to development fees. For the six months ended June 30,
2010, we incurred €2.5 million in research and development expenses attributable
to development fees, representing 23% of our total research and development
expenses. This represented a decrease of €1.4 million compared to the same
period in 2009. The largest component of these research and development expenses
attributable to development fees was personnel costs. For the six months ended
June 30, 2010, €0.9 million of personnel costs were incurred compared to €1.3
million for the same period in 2009. With more than 10 active external projects
during the six months ended June 30, 2010 and 2009, no single project was
individually significant.
Other Research and Development
Expenses.
In our consolidated statement of operations, we refer to
internal research and development expenses as other research and development
expenses. For the six months ended June 30, 2010, we incurred €8.5 million in
other research and development expenses, representing 77% of our total research
and development expenses. This represented an increase of €0.6 million compared
to the same period in 2009. Certain components of our other research and
development expenses, notably clinical study activity, can significantly vary
from quarter to quarter. Both for the six months ended June 30, 2010 and 2009,
the only internal project that was individually significant with respect to our
total research and development expenses was ZENPEP® (EUR-1008). In the six
months ended June 30, 2010 development costs for EUR-1008 were €2.9 million and
€3.4 million in the same period in 2009. For the six months ended June 30, 2010
and 2009, the portion of our research and development expenses attributable
to other internal development projects was €5.6 million and €4.5
million,
respectively,
and was comprised of multiple projects, none of which was individually
significant in relation to our total research and development
expenses.
Selling, General and Administrative
Expenses.
Selling, general and administrative expenses were
€25.1
million for
the six months ended June 30, 2010 compared to
€
16.7 million
for the same period in 2009, representing an increase of
€8.4 million,
ap
proximately 51% or
€
8.1 million,
approximately 49% if the currency effects were excluded. This is
primarily attributable to an increase in direct sales and marketing expenses
associated with the launch of ZENPEP, the expansion of the sales force, and
related marketing, patient support and managed care programs.
Income tax expense.
For the
six months ended June 30, 2010, we recorded income taxes of
€
2.0 million
on a pre-tax loss of
€992
thousand
. In the six months ended June 30, 2009, we
recorded income taxes of approximately
€2
.2 million
on a pre-tax income of
€654
thousand
. Our taxes do not correlate directly to our
consolidated profit and loss before tax for two main reasons. First,
we are subject to certain local income taxes in Italy for which most labor and
financial costs are non-deductible. Second, we have recorded
valuation allowances to reduce deferred tax assets and withholding taxes
recoverable in certain operating subsidiaries that are not generating taxable
profits on a recurring basis to amounts that are deemed more likely than not to
be recovered.
Changes in Financial
Position
Cash and cash equivalents
.
Cash and cash equivalents were €20.7 million as of June 30, 2010 compared to
€16.9 million as of December 31, 2009. Our cash and cash equivalents increased
primarily due to cash received on maturity of marketable securities of €12.6
million and cash received from long-term bank borrowings of €3.0 million, which
more than offset purchase of marketable securities of €5.3 million, cash used in
operating activities in the period of €3.2 million and investments in property,
plant and equipment of €1.8 million.
Marketable securities
.
Marketable securities were €17.6 million as of June 30, 2010 compared to €23.0
million as of December 31, 2009.
Total shareholders’ equity
.
Shareholders’ equity on June 30, 2010 did not change from December 31, 2009 and
was €111.6 million, primarily as a result of the following offsetting equity
changes: a net loss of €3.0 million, the effects of share-based compensation of
€1.4 million and a positive exchange translation adjustment of €1.6
million.
Off Balance Sheet
Arrangements
As of
June 30, 2010, we did not have any off balance sheet arrangements.
Exchange Rate
Risk
Our
European operations use the euro as the functional currency, and our U.S.
operations use the U.S. dollar as the functional currency. We express our
consolidated financial statements in euros. Our European operations transact
business in euros primarily with European customers, with the notable exception
of Axcan, our largest customer. Our U.S. operations transact business in U.S.
dollars primarily with U.S. customers. We recognize the cumulative effect of
foreign currency translations as a separate component of shareholders’
equity.
A
hypothetical 10% appreciation in currency exchange rates against the U.S. dollar
from the prevailing market rates would have increased our pre-tax loss by
approximately €874 thousand for the six months ended June 30, 2010. Conversely,
a hypothetical 10% depreciation in currency exchange rates against the U.S.
dollar from the prevailing market rates would have decreased our pre-tax loss by
approximately €1.1 million for the six months ended June 30, 2010.
Impact of
Inflation
We do not
believe that inflation has had a material effect on our business, results of
operations or financial condition for any of the periods discussed or that
inflation will affect us to a different extent than it affects the general
economy.
PART
II. OTHER INFORMATION
Risk
Factors
There
have been no material changes from the risk factors set forth in the Company's
quarterly report on Form 6-K for the quarter ended March 31,
2010.
Pursuant to the requirements of the
Securities Exchange Act of 1934, the registrant has duly caused this report to
be signed on its behalf by the undersigned, thereunto duly
authorized.
Date: August 6, 2010
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EURAND
N.V.
|
|
(Registrant)
|
|
|
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By:
|
/s/Mario
Crovetto
|
|
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Mario
Crovetto
|
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Chief
Financial Officer
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