27% Revenue Increase for Full Year 2006; 15% Revenue Increase for
Fourth Quarter IRVINE, California and LAUSANNE, Switzerland,
February 26 /PRNewswire-FirstCall/ -- IsoTis, Inc (ISOT), a leading
orthobiologics company, today reported results for the fourth
quarter and full year ended December 31, 2006. Revenue was $9.9
million for the fourth quarter of 2006, representing a 15% increase
over revenue of $8.6 million for the fourth quarter of 2005. For
the full year 2006, revenue was $40.7 million, representing a 27%
increase over revenue of $32.1 million for the full year 2005. The
results of operations reported in this press release are those of
IsoTis S.A. (SWX/Euronext: ISON) (TSX: ISO), the former parent
entity of IsoTis, Inc. and now a subsidiary of IsoTis, Inc. IsoTis,
Inc. was formed for the purpose of reorganizing IsoTis S.A. into
the United States, which it accomplished by means of an exchange
offer that resulted in IsoTis, Inc. acquiring more than 90% of the
outstanding shares of IsoTis S.A. In connection with the exchange
offer, the shares of IsoTis, Inc. started trading on NASDAQ on
January 26, 2007. IsoTis, Inc. intends to cause IsoTis S.A. to
delist its shares from the Toronto Stock Exchange and Euronext
Amsterdam. IsoTis, Inc. also intends to effect a squeeze-out merger
to acquire the remaining IsoTis S.A. shares. Following the
squeeze-out merger, IsoTis S.A. will be a wholly-owned subsidiary
of IsoTis, Inc. and its shares will no longer trade on the SWX
Swiss Exchange. The squeeze-out merger is expected to be completed
in the first half of 2007. As a result, unless the context
otherwise states, references throughout this press release to
"IsoTis" or the "company" refer to the business of IsoTis S.A. and
its subsidiaries for all periods prior to the consummation of the
exchange offer and to the business of IsoTis, Inc. and that of its
subsidiaries for all periods subsequent to the consummation of the
exchange offer. Revenue Analysis IsoTis' chief distribution
channels are its U.S. network of independent distributor agents and
its network of international stocking distributors, while the
remaining portion of its revenues is derived from private label
partners in the United States and internationally. In the fourth
quarter of 2006, revenue from the U.S. independent distributor
agents grew 8% to $6.3 million compared to $5.8 million in the
fourth quarter of 2005, while for the full year 2006, revenue from
the U.S. independent distributor agents grew 15% to $25.9 million,
compared to $22.6 million for the full year 2005. In the fourth
quarter of 2006, revenue from international stocking distributors
decreased 7% to $2.1 million compared to $2.3 million in the fourth
quarter of 2005, while for the full year 2006 revenue from
international stocking distributors grew 30% to $9.6 million,
compared to $7.4 million for the full year 2005. In the fourth
quarter of 2006, revenue from private label partners grew 150% to
$1.5 million compared to $0.6 million in the fourth quarter of
2005, while for the full year 2006 revenue from private label
partners grew 160% to $5.2 million compared to $2.0 million for the
full year 2005. Results Comparison & Cash Position The loss
from operations for the fourth quarter of 2006 was $4.3 million,
compared to $2.7 million for the fourth quarter of 2005. For the
full year 2006, the loss from operations was $12.1 million,
compared to $9.9 million for the full year 2005. Net loss for the
fourth quarter of 2006 totaled $6.6 million or $0.09 per diluted
share as compared with a net loss of $1.4 million or $0.02 per
diluted share for the fourth quarter of 2005. The net loss for the
full year ended December 31, 2006 was $18.5 million or $0.26 per
share due in part to the $7.0 million negative impact of foreign
currency movements on intercompany loans. For the full year ended
December 31, 2005 net income was $0.9 million or $0.01 per share
which was primarily due to a $10.0 million favorable impact of
foreign currency movements on intercompany loans. In January 2007,
IsoTis, Inc. capitalized these intercompany loans, which it
believes will result in substantially reduced foreign exchange
fluctuations going forward. The fourth quarter results were
negatively impacted by several non-recurring items. These
non-recurring items included the costs for outside advisors and
exchange agents in four jurisdictions associated with the Company's
successful transformation to a US-based NASDAQ listed company,
which amounted to approximately $2.7 million. The negative impact
was offset, in part, by a $1.8 million one-time reversal of a
provision the Company had taken in 2002 related to a claim by the
Dutch tax authorities. The Company appealed this claim in court and
won. At December 31, 2006, IsoTis had cash and cash equivalents and
restricted cash of $16.3 million. Highlights 2006 & Year to
Date - Successful exchange offer to establish IsoTis as a U.S.
company with a NASDAQ listing - Key US patent for Accell technology
- Sale of dental assets to Keystone Dental Inc. for $7.4 million -
Secured $5 million credit line with SVB Silicon Valley Bank - Key
management & board of director appointments - Private label
agreement with Alphatec Spine Other Recent Events As disclosed on
February 14, 2007, IsoTis received a letter from the U.S. Food and
Drug Administration (FDA) on February 7, 2007 with additional
comments and questions regarding the pending 510(k) application for
some of its Accell products. The letter raises a jurisdictional
question as to how the Accell products should be regulated. IsoTis
has responded to the letter and requested a meeting with the FDA to
discuss its questions. The Company believes that it can continue to
market Accell Putty and Accell TBM as human tissue until it
receives 510(k) clearance, although there is no assurance that this
will be the case. In light of this regulatory situation, and as
also previously disclosed, the Company has decided not to proceed
with its proposed public offering at this time and is taking a
number of measures intended to reduce the use of its cash reserves
without impacting its ability to manufacture and supply its
customers. Pieter Wolters, President and CEO of IsoTis said, "We
are very pleased with our achievements in 2006. We are reporting
our ninth consecutive quarter of comparable quarter revenue growth.
We believe the continuous strong growth of Accell sales indicates
that surgeons are experiencing positive outcomes using our product:
since the first Accell product launch in 2002, we have sold more
than 50,000 units of Accell. We improved our gross profit margin
percentage by approximately 4% to 62.9% in 2006. Our recent NASDAQ
listing provides a viable platform from which we believe we can
sustain our growth. While we believe that the prospects for IsoTis
are excellent, we will not provide financial guidance for 2007
pending a positive outcome of our discussions with the FDA on the
regulatory status of our Accell products, as discussed in our
February 14, 2007 press release." Conference Call IsoTis has
scheduled a conference call to discuss these results today February
26, 2007 at 5 pm EST. US Dial In: toll free 1 800.798.2864; toll 1
617. 614. 6206; UK Dial In 44 20 7365 8426; Continental Europe Dial
In: 41 1 800 9569; password: IsoTis. Digital playback is available
from February 27 at 7:00 p.m. for 24 hours. US Dial In: 1 617801
6888; European Dial In 44 20 7365 8427; playback ID: 22040500. To
listen to the conference call live via the internet, visit the
Investors section of the IsoTis website at http://www.isotis.com/.
Please go to the website 15 minutes prior to the call to register,
download and install the necessary audio software. About IsoTis
IsoTis is a leading orthobiologics company that develops,
manufactures and markets proprietary products for the treatment of
musculoskeletal diseases and disorders. IsoTis' current
orthobiologics products are bone graft substitutes that promote the
regeneration of bone and are used to repair natural, trauma-related
and surgically-created defects common in orthopedic procedures,
including spinal fusions. IsoTis' current commercial business is
highlighted by its Accell line of products, which the company
believes represents the next generation in bone graft substitution.
Certain statements in this press release are "forward-looking
statements" within the meaning of Section 21E of the Securities
Exchange Act of 1934, as amended, including those that refer to
management's plans and expectations for future operations,
prospects and financial condition. Words such as "strategy,"
"expects," "plans," "anticipates," "believes," "will," "continues,"
"estimates," "intends," "projects," "goals," "targets" and other
words of similar meaning are intended to identify such
forward-looking statements. One can also identify them by the fact
that they do not relate strictly to historical or current facts.
Such statements are based on the current expectations of the
management of IsoTis only. Undue reliance should not be placed on
these statements because, by their nature, they are subject to
known and unknown risks and can be affected by factors that are
beyond the control of IsoTis. Actual results could differ
materially from current expectations due to a number of factors and
uncertainties affecting IsoTis' business, including, but not
limited to, a competitive sales and marketing environment, the
timely commencement and success of IsoTis' clinical trials and
research endeavors, delays in receiving U.S. Food and Drug
Administration or other regulatory approvals (a.o. EMEA, CE),
including the risk that the FDA determines that our Accell Putty
and Accell TBM products are not human tissue or class II medical
devices, that the Company is unable to obtain 510(k) clearance for
its Accell products, that the FDA requires the Company to obtain
premarket approval of its Accell products prior to continuing their
marketing, that the FDA requires the Company to produce additional
clinical data to support approval or clearance of its products,
that the FDA imposes compliance measures against the Company for
the marketing of its Accell products, including imposing fines and
injunctions or causing the Company to recall its Accell products,
market acceptance of IsoTis' products, effectiveness of IsoTis'
distribution channels, development of competing therapies and/or
technologies, the terms of any future strategic alliances, the need
for additional capital, the inability to obtain, or meet,
conditions imposed for required governmental and regulatory
approvals and consents. IsoTis expressly disclaims any intent or
obligation to update these forward-looking statements except as
required by law. For a more detailed description of the risk
factors and uncertainties affecting IsoTis, refer to IsoTis' Annual
Report on Form 20-F for the fiscal year ended December 31, 2005,
and its other reports filed with the SEC, IsoTis' reports filed
from time to time with the Swiss Stock Exchange (SWX), Euronext
Amsterdam N.V., SEDAR at http://www.sedar.com/ and the Toronto
Stock Exchange (TSX) and the reports filed with the SEC from time
to time by IsoTis, Inc., the successor in interest to IsoTis S.A.
IsoTis S.A. Consolidated Statements of Operations US Dollars Three
Months Year Ended Ended December 31, December December 31, December
2006 31, 2005 2006 31, 2005 (Unaudited) (Unaudited) (Unaudited)
Revenues Product sales $ 9,932,615 $ 8,613,412 $ 40,661,728 $
32,063,461 Other revenue - - 35,816 38,825 Total revenues 9,932,615
8,613,412 40,697,544 32,102,286 Operating expenses Costs of sales
3,766,753 3,926,929 15,071,566 13,114,233 Research and development
2,151,027 2,130,585 7,742,795 6,330,136 Marketing and selling
3,954,457 3,752,246 17,155,432 13,140,497 General and
Administrative 4,373,161 1,510,024 12,818,895 9,424,863 Total
operating expenses 14,245,398 11,319,784 52,788,688 42,009,729 Loss
from operations (4,312,783) (2,706,372) (12,091,144) (9,907,443)
Interest income 167,354 160,046 607,375 546,021 Interest expense
(17,531) (249,556) (149,750) (406,111) Foreign exchange (loss) gain
(2,403,576) 1,356,579 (6,971,614) 9,981,769 Other (15,131) 31,345
126,969 694,696 Net (loss) income before taxes (6,581,667)
(1,407,958) (18,478,164) 908,932 Provision for income taxes Net
(loss) income $ (6,581,667) $ (1,407,958)$ (18,478,164) $ 908,932
Basic and diluted net (loss) income per share $ (0.09) $ (0.02)$
(0.26) $ 0.01 Weighted average common shares outstanding Basic
70,944,753 70,804,821 70,925,009 70,464,330 Diluted 70,944,753
70,804,821 70,925,009 72,447,640 IsoTis S.A. Consolidated Balance
Sheets US Dollars December 31, December 31, 2006 2005 (Unaudited)
Assets Current assets: Cash and cash equivalents $ 13,362,915 $
15,714,442 Restricted cash 1,659,787 2,184,063 Trade receivables,
net 7,463,194 6,306,518 Other receivables 374,061 390,620
Inventories 14,211,189 10,020,906 Prepaid expenses and other
current assets 923,746 761,355 Total current assets 37,994,892
35,377,904 Non-current assets: Restricted cash 1,250,000 2,250,000
Property, plant and equipment, net 3,907,175 1,359,280 Goodwill
16,383,069 16,383,069 Intangible assets, net 11,026,656 13,585,250
Total non-current assets 32,566,900 33,577,599 Total assets $
70,561,792 $ 68,955,503 Liabilities and stockholders' equity
Current liabilities: Trade payables $ 6,707,212 $ 2,910,114 Accrued
liabilities 6,560,894 6,680,989 Deferred revenue 1,342,797 344,719
Current portion of interest-bearing Loans 3,751,201 1,015,471 and
borrowings Total current liabilities 18,362,104 10,951,293
Non-current liabilities: Interest-bearing loans and borrowings
1,696,963 2,043,781 Deferred revenue 4,792,638 Other long term
liabilities 279,025 Total non-current liabilities 6,768,626
2,043,781 50,728,864 50,644,949 106,867,774 106,212,297 20,141,408
12,932,003 (132,306,984) (113,828,820) Total stockholders' equity
45,431,062 55,960,429 Total liabilities and stockholders' Equity $
70,561,792 $ 68,955,503 IsoTis S.A. Consolidated Statements of Cash
Flows US Dollars Year Ended December 31, 2006 December 31, 2005
(Unaudited) Cash flows from operating activities Net (loss) income
$ (18,478,164) $ 908,932 Adjustments to reconcile net (loss) income
to net cash used in operating activities: Depreciation and
amortization 3,352,068 3,408,066 Bad debt expense 228,089 240,923
Loss (gain) on sale of assets 42,831 (653,580) Issuance of shares
for services 10,311 - Stock-based compensation expense 620,826
411,459 Reversal of legal claim accrual (1,772,716) - Foreign
currency transaction loss 6,971,614 (9,981,769) (gain) Change in
operating assets and liabilities: Inventories (4,090,175) (890,949)
Trade receivables (1,497,431) (2,411,000) Other current assets
(41,238) 928,732 Deferred revenue (726,378) 288,940 Trade and other
payables 4,927,089 (835,099) Other long term liabilities 279,025 -
Restructuring provision - (673,197) Net cash flows used in
operating activities (10,174,249) (9,258,542) Cash flows from
investing activities Purchase of property, plant and equipment
(3,357,320) (555,876) Proceeds from sale of intangible assets -
250,000 Change in restricted cash 1,628,164 2,820,277 Proceeds from
sale of property, plant and equipment and assets 6,990,101
2,532,202 Net cash flows provided by investing activities 5,260,945
5,046,603 Cash flow from financing activities Proceeds from
issuance of common shares 108,255 892,051 Proceeds from
interest-bearing loans 5,100,000 - and borrowings Repayment of
interest-bearing loans and borrowings (2,717,043) (6,448,281) Net
cash flows provided by (used in) financing activities 2,491,212
(5,556,230) Gain (loss) on cash held in foreign currency 70,565
(56,992) Net decrease in cash and cash equivalents (2,351,527)
(9,825,161) Cash and cash equivalents at the beginning of year
15,714,442 25,539,603 Cash and cash equivalents at the end of year
$ 13,362,915 $ 15,714,442 DATASOURCE: Isotis Inc CONTACT: For
information contact: Rob Morocco, CFO Hans Herklots, Director IR,
+1-949-855-7155 +1-949-855-7195,
Copyright