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Gensci
Parent Dismissed from Chapter 11
Toronto
/ Irvine / Lausanne / Bilthoven, August 5, 2003 – GenSci Regeneration
Sciences Inc. (TSX: GNS) and Biosurgery company IsoTis S.A. (SWX/Euronext
Amsterdam: ISON), today announced that the U.S. Bankruptcy Court,
Central District of California, has entered an order dismissing
GenSci Regeneration Sciences Inc. (GenSci Regeneration) from Chapter
11. This marks an important step towards completion of the proposed
merger between IsoTis and GenSci announced in early June. Both companies
further confirmed that reciprocal due diligence has now been successfully
completed.
Chapter 11
proceedings
GenSci Regeneration requested that the dismissal order be granted,
with the support of its creditors, to allow GenSci Regeneration
to proceed toward completion of the planned merger of its wholly
owned subsidiary, GenSci OrthoBiologics Inc., with IsoTis. GenSci
OrthoBiologics will remain under the protection of Chapter 11 pending
a confirmation hearing expected to be held in October 2003. In order
to effectuate the dismissal, IsoTis has funded US$200,000 for payment
of GenSci Regeneration’s pre-petition unsecured claims and post-petition
administrative claimants, including, but not limited to professional
fees, excluding (i) post-petition creditors whose claims are paid
in the ordinary course of business and not yet due, and (ii) Osteotech,
Inc.
Based upon an
agreement between GenSci Regeneration, the Creditors’ Committee
appointed in GenSci OrthoBiologics' Chapter 11 case, IsoTis, and
Osteotech, in the event that the merger of GenSci OrthoBiologics
and IsoTis is not completed by January 31, 2004 the dismissal order
shall be vacated, and the Chapter 11 case of GenSci Regeneration
would be reinstated.
Merger agreement
The merger agreement has been amended, to include completion of
due diligence and schedules and clarification of the number of IsoTis
shares to be issued to GenSci shareholders. Both companies reconfirmed
the merger agreement following the dismissal of GenSci Regeneration
from Chapter 11. The maximum number of shares to be issued has been
reduced to 29,150,000 from 29,450,000 to permit the inclusion of
a US$600,000 cash component to cover transaction costs. The maximum
number of shares to be issued will be reduced by the number of IsoTis
shares reserved for GenSci employees who will participate in the
IsoTis share option plan (approximately 2.2 million IsoTis shares
are expected to be reserved for this purpose), and by shares that
will not be issued to dissenting GenSci shareholders (if any).
Q2, 2003 reporting
to coincide with information circular & change to US GAAP
IsoTis and GenSci will each publish half-year 2003 results simultaneously
with the publication of the information circular, no later than
early September. The precise date will be announced in advance and
as soon as it is available. IsoTis originally planned to publish
its results on August 11th. However, in connection with the intended
merger, IsoTis will cease to report in accordance with International
Accounting Standards (IAS), and will henceforth report exclusively
in accordance with US GAAP. The IsoTis S.A. Q2 results will thus
be published under US GAAP, with the reporting currency in EUR,
and will be accompanied by a full set of figures under IAS. Both
sets of numbers will include historic comparisons. Beginning Q3,
2003, the company will change its reporting currency from EUR to
USD.
Next steps
• GenSci OrthoBiologics has filed the requisite amended court documents
(Disclosure Statement and Plan of Reorganization). A hearing to
approve the Disclosure Statement is scheduled for August 26, 2003.
• IsoTis and GenSci anticipate issuing a combined information circular
and prospectus no later than early September 2003.
• Q2 2003 results will be issued by IsoTis and GenSci to coincide
with publication of the information circular.
• Extraordinary general shareholder meetings of IsoTis and GenSci
to approve the issuance of shares and to consider the plan of arrangement
respectively will be held no later than October 2003. The merger
is expected to become effective no later than October 2003.
Note
On June 3, 2003, IsoTis and GenSci announced their intention to
merge to create a leading orthobiologics player with a global presence.
The official announcement can be found on www.isotis.com or www.gensciinc.com.
Summary of
merger rationale:
The merger will create a dedicated and global orthobiologics player
focused on the double-digit growth market of bone substitutes. The
combined IsoTis/GenSci product portfolio will have a broad presence
in both “natural” demineralized bone matrix (DBM) products and “synthetic”
bone substitutes. As DBM products are more common in North America
and synthetic bone substitutes are more common in Europe, the IsoTis/GenSci
product portfolio is well positioned to capitalize on significant
commercial opportunities in both of these major markets.
Further, IsoTis/GenSci
expects to sustain continued long-term growth in revenues through
aggressive development of its innovative orthobiologics pipeline.
The two companies have already identified a variety of ongoing product
development programs that have the potential to lead to breakthrough
products in musculoskeletal repair.
Combining
the companies:
With product sales exceeding US $22 million and positive cash flow
from operations in 2002, GenSci is recognized as a significant participant
in the North American bone graft substitute market. Its OrthoBlast®
II, DynaGraft® II, and Accell® DBM100 product lines are well recognized
and accepted in the orthopedic community.
IsoTis contributes
its innovative synthetic bone substitute OsSatura™ to the combination,
together with a range of small medical devices, and its highly promising
PolyActive BCP program, which constitutes a potential advance in
the treatment of osteochondral knee defects. In the first half of
2003, OsSatura™ received both the CE mark (on the claim of osteoinductivity)
and FDA 510(k) clearance in quick succession and has been contributing
to revenues as of Q1, 2003. IsoTis’ total 2002 sales amounted to
€ 2 million (US$ 2.3 million).
IsoTis has
a solid cash position of € 75 million (US$ 84 million) at March
31, 2003, an innovative product pipeline, and proven ability to
execute a complex cross border merger on a timely and efficient
basis.
IsoTis, the
Leading European Biosurgery Company
IsoTis was created in Q4 2002 through the merger of Modex, a biotechnology
company, and IsoTis, a Dutch biomedical company. The company operates
out of its corporate headquarters in Lausanne, Switzerland, and
its facilities in Bilthoven, The Netherlands. In Q1, 2003, it completed
a restructuring of the company by rationalizing its product portfolio
and substantially reducing its cash burn. IsoTis currently has 100
employees, a product portfolio with several orthobiologic medical
devices on the market and in development, and is traded under the
symbol “ISON” on both the Official Market Segment of Euronext Amsterdam
and the Main Board of the Swiss Exchange.
GenSci, the
Orthobiologics Technology CompanyTM
GenSci Regeneration Sciences, Inc. is a publicly traded company
listed on the Toronto Stock Exchange (TSX -"GNS") with corporate
headquarters in Toronto, Ontario. GenSci OrthoBiologics, Inc., the
company's wholly-owned subsidiary based in Irvine, California, focuses
on the research, development, production, and distribution of bioimplant
products for the orthopedic and spine markets. GenSci OrthoBiologics
is the company’s principal operating subsidiary. The company's products
are currently sold in over 1,500 hospitals across North America,
with a growing international presence throughout Latin America,
Europe, and Asia. GenSci has 85 employees.
(Certain statements
in this Press Release are “forward-looking statements”, including
those that refer to management’s plans and expectations for future
operations, prospects and financial condition. One can identify
these forward-looking statements by use of words such as 'strategy,'
'expects,' 'plans,' 'anticipates,' 'believes,' 'will,' 'continues,'
'estimates,' 'intends,' 'projects,' 'goals,' 'targets' and other
words of similar meaning. 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 S.A. and GenSci only. 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/GenSci. Actual results could differ materially
from current expectations due to a number of risk factors and uncertainties,
including but not limited to the timely commencement and success
of IsoTis’ and GenSci’s clinical trials and research endeavors,
delays in receiving U.S. FDA or other regulatory approvals (a.o.
EMEA, CE), market acceptance of the combined Company’s’ products,
development of competing therapies and/or technologies, the terms
of any future strategic alliances, the need for additional capital,
the failure of IsoTis or GenSci shareholders to approve the merger
transaction, the inability to obtain, or meet conditions imposed
for the required governmental and regulatory approvals and consents,
the risk that IsoTis and GenSci will not consummate the transaction,
or that implementing the merger may not provide all or any of the
benefits projected as it will place significant demands on our management.
For a more detailed description of the risk factors and uncertainties
affecting IsoTis, refer to IsoTis’ reports filed from time to time
with the Swiss Stock Exchange, SWX, Euronext Amsterdam N.V. For
a more detailed description of the risk factors and uncertainties
affecting GenSci, refer to GenSci’s reports filed from time to time
with the Canadian securities regulators, available at www.sedar.com.
IsoTis and GenSci are not obligated to update or revise any forward-looking
statements, whether as a result of new information or otherwise.
This communication
shall not constitute an offer to sell or the solicitation of an
offer to buy securities, nor shall there be any sale of securities
in any jurisdiction in which such offer, solicitation or sale would
be unlawful prior to registration or qualification under the securities
laws of such jurisdiction.)
Return
to headlines
Announces
Pre-merger Licensing Agreement
Lausanne / Bilthoven / Irvine / Toronto, 24 June, 2003 – Biosurgery company IsoTis S.A. (SWX/Euronext Amsterdam: ISON) and orthobiologics leader GenSci Regeneration Sciences, Inc. (TSX: GNS) today announced the signing of a licensing agreement that will allow both companies to aggressively move forward with the integration of their development teams and product platforms in advance of the completion of their recently proposed merger.
Under the licensing agreement, IsoTis gains access to the advanced carrier and delivery systems of GenSci OrthoBiologics. The carrier system is a unique reverse-phase medium (RPM), so called because it is malleable at operating room temperature, but thickens at the surgical site’s higher body temperature. The RPM technology provides exceptional handling and containment properties to GenSci’s demineralized bone matrix (DBM) products. The proprietary reverse phase carrier system is currently being used in several of GenSci’s DBM products, and has been a critical success factor in the rapid adoption of these products within the surgical community.
In exchange for the agreement GenSci will receive an upfront payment, milestone payments, and royalties on sales. Details are not disclosed.
Both companies regard it as essential to speed up the integration of their teams and technologies, and see this licensing agreement as a first concrete step towards forging a unified company while working towards the completion of the merger transaction expected this fall. Combining the RPM and delivery systems with its lead product OsSatura, a synthetic bone substitute that received the CE mark and FDA clearance earlier this year, will enable IsoTis to accelerate the expansion of its product range. The first project will focus on OsSatura RPM for dental and maxillofacial reconstruction. GenSci will in turn get access to additional working capital to increase its inventory level and meet increasing market demand for its innovative products.
Jacques Essinger, Chief Executive Officer, IsoTis S.A. said:
“We want to start capitalizing on each other’s know-how as soon as possible, and start bringing the teams together today. This agreement is a good example of our pragmatic approach, and demonstrates the business, technological, and personal synergies between IsoTis and GenSci. The teams are already working together on the OsSatura RPM development, and judging from the current stage of the project, tangible results can be expected before the completion of our merger, which we have every confidence will be approved by our respective shareholders.”
Douglass Watson, President and Chief Executive Officer, GenSci commented:
“This collaboration is the natural outcome of the excellent fit between GenSci and IsoTis, and only the beginning. I expect that the combination of our respective technologies will lead to unique product combinations that will allow us to service the orthopedic, dental, and craniofacial markets with a broad and innovative suite of products. This agreement will also provide GenSci with additional financial resources to increase our growth rate in anticipation of the merger completion.”
Note to the editor
On June 3, 2003, IsoTis and GenSci announced their intention to merge to create a leading orthobiologics player with a global presence.
Summary of merger rationale:
The merger will create a dedicated and global orthobiologics player focused on the double-digit growth market of bone substitutes. The combined IsoTis/GenSci product portfolio will have a broad presence in both “natural” demineralized bone matrix (DBM) products and “synthetic” bone substitutes. As DBM products are more common in North America and synthetic bone substitutes are more common in Europe, the IsoTis/GenSci product portfolio is well positioned to capitalize on significant commercial opportunities in both of these major markets.
Further, IsoTis/GenSci expects to sustain continued long-term growth in revenues through aggressive development of its innovative orthobiologics pipeline. The two companies have already identified a variety of ongoing product development programs that have the potential to lead to breakthrough products in musculoskeletal repair.
Combining the companies:
With product sales exceeding US $22 million and positive cash flow from operations in 2002, GenSci is recognized as a significant participant in the North American bone graft substitute market. Its OrthoBlast® II, DynaGraft® II, and Accell® DBM100 product lines are well recognized and accepted in the orthopedic community.
IsoTis contributes its innovative synthetic bone substitute OsSatura™ to the combination, together with a range of small medical devices, and its highly promising PolyActive BCP program, which constitutes a potential advance in the treatment of osteochondral knee defects. In the first half of 2003, OsSatura™ received both the CE mark (on the claim of osteoinductivity) and FDA 510(k) clearance in quick succession and has been contributing to revenues as of Q1, 2003. IsoTis’ total 2002 sales amounted to € 2 million (US$ 2 million).
IsoTis has a solid cash position of € 75 million (US$ 82 million) at March 31, 2003, an innovative product pipeline, and proven ability to execute a complex cross border merger on a timely and efficient basis.
IsoTis, the Leading European Biosurgery Company
IsoTis was created in Q4 2002 through the merger of Modex, a Swiss biotechnology company, and IsoTis, a Dutch biomedical company. The company operates out of its corporate headquarters in Lausanne, Switzerland, and its facilities in Bilthoven, The Netherlands. In Q1, 2003, it completed a restructuring of the company by rationalizing its product portfolio and substantially reducing its cash burn. IsoTis currently has 100 employees, a product portfolio with several orthobiologic medical devices on the market and in development, and is traded under the symbol “ISON” on both the Official Market Segment of Euronext Amsterdam and the Main Board of the Swiss Exchange.
GenSci, the Orthobiologics Technology CompanyTM
GenSci Regeneration Sciences, Inc. is a publicly traded company listed on the Toronto Stock Exchange (TSX -"GNS") with corporate headquarters in Toronto, Ontario. GenSci OrthoBiologics, Inc., the company's wholly owned subsidiary based in Irvine, California, focuses on the research, development, production, and distribution of bioimplant products for the orthopedic and spine markets. GenSci OrthoBiologics is the company’s principal operating subsidiary. The company's products are currently sold in over 1,550 hospitals across North America, with a growing international presence throughout Latin America, Europe, and Asia. GenSci has 85 employees.
(Certain statements in this Press Release are “forward-looking statements”, including those that refer to management’s plans and expectations for future operations, prospects and financial condition. One can identify these forward-looking statements by use of words such as 'strategy,' 'expects,' 'plans,' 'anticipates,' 'believes,' 'will,' 'continues,' 'estimates,' 'intends,' 'projects,' 'goals,' 'targets' and other words of similar meaning. 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 S.A. and GenSci only. 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/GenSci. Actual results could differ materially from current expectations due to a number of risk factors and uncertainties, including but not limited to the timely commencement and success of IsoTis’ and GenSci’s clinical trials and research endeavors, delays in receiving U.S. FDA or other regulatory approvals (a.o. EMEA, CE), market acceptance of the combined Company’s’ products, development of competing therapies and/or technologies, the terms of any future strategic alliances, the need for additional capital, the failure of IsoTis or GenSci shareholders to approve the merger transaction, the inability to obtain, or meet conditions imposed for the required governmental and regulatory approvals and consents, the risk that IsoTis and GenSci will not consummate the transaction, or that implementing the merger may not provide all or any of the benefits projected as it will place significant demands on our management. For a more detailed description of the risk factors and uncertainties affecting IsoTis, refer to IsoTis’ reports filed from time to time with the Swiss Stock Exchange, SWX, Euronext Amsterdam N.V. For a more detailed description of the risk factors and uncertainties affecting GenSci, refer to GenSci’s reports filed from time to time with the Canadian securities regulators, available at www.sedar.com. IsoTis and GenSci are not obligated to update or revise any forward-looking statements, whether as a result of new information or otherwise.
This communication shall not constitute an offer to sell or the solicitation of an offer to buy securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.)
Return to headlines
Isotis
And Gensci Merger To Create Orthobiologics Leader With Global
Presence
Irvine,June 3 , 2003 - Biosurgery company IsoTis S.A. (SWX/Euronext Amsterdam: ISON) and orthobiologics leader GenSci Regeneration Sciences, Inc. (TSX: GNS) today announced the signing of a definitive merger agreement to create a dynamic new competitor in orthobiologics. The Boards of Directors of both companies have unanimously approved the intended merger.
Highlights:
• Combined sales of US$ 24 million in 2002 through existing US and European distribution channels
• Realistic industry double digit annual growth forecast, resulting in management expecting profitability in 2005
• US$ 85 million (€ 78 million) in cash as of Q1 2003 to accelerate internal and external growth
• Powerful presence in both synthetic and natural bone substitutes with innovative near-term pipeline
• Lean, recently restructured companies are a natural match
• Creates robust player with critical mass in fast growing field
• IsoTis and GenSci current shareholders to own 60% and 40%, respectively, of combined company
Rationale:
The merger will create a dedicated and global orthobiology player focused on the double-digit growth market of bone substitution. The combined IsoTis/GenSci product portfolio will have a broad presence in both “natural” demineralized bone matrix (DBM) products and “synthetic” bone substitutes. As DBM products are more common in North America and synthetic bone substitutes are more common in Europe, the IsoTis/GenSci product portfolio is well positioned to capitalize on significant commercial opportunities in both of these major markets. Further, IsoTis/GenSci expects to sustain continued long-term growth in revenues through aggressive development of its innovative orthobiology pipeline. The two companies have already identified a variety of ongoing product development programs that have the potential to lead to breakthrough products in musculoskeletal repair.
Combining the companies:
With product sales exceeding US$ 22 million (€ 24 million) and positive cash flow from operations in 2002, GenSci is recognized as a significant participant in the North American bone substitution market. Its OrthoBlast® II, DynaGraft® II, and Accell® DBM 100 product lines are well-recognized and accepted in the orthopedic community. IsoTis contributes its innovative synthetic bone substitute OsSatura™ to the combination, together with a range of small medical devices, and its highly promising PolyActive BCP program, which constitutes a potential breakthrough in the treatment of osteochondral knee defects. In the first half of 2003, OsSatura™ received both the CE mark (on the claim of osteoinductivity) and FDA 510(k) approval in quick succession and has been contributing to revenues as of Q1, 2003. IsoTis’ total 2002 sales amounted to € 2 million (US$ 2 million). In light of recent revenue growth and market penetration trends at both companies, management of the two companies expects that full-year combined 2003 revenue will comfortably exceed 2002 combiined revenue. IsoTis/GenSci management also anticipates substantial sales and marketing synergies from the ability to commercialize their respective product lines through the established distribution infrastructure of GenSci in North America and of IsoTis in Europe. In light of these benefits and the above-referenced double digit revenue growth trends, management is confident that robust growth is sustainable for 2004 and 2005, laying the foundation for the expectation of the combined company turning profitable during 2005. The existing operational infrastructure of the combination in Europe and the US is state-of-the-art. IsoTis has GMP-approved and ISO-certified production facilities, labs and offices in Bilthoven, The Netherlands, as well as in Lausanne, Switzerland. GenSci has GMP-approved and ISO-certified production facilities, labs and offices in Irvine, California. IsoTis has a solid cash position of € 75 million (US$ 82 million) at March 31, 2003, an innovative product pipeline, and proven ability to execute a complex cross border merger on a timely basis and efficiently.
IsoTis, the Leading European Biosurgery Company
IsoTis was created in Q4 2002 through the merger of Modex, a Swiss biotechnology company, and IsoTis, a Dutch biomedical company. The company operates out of its corporate headquarters in Lausanne, Switzerland, and its facilities in Bilthoven, The Netherlands. In Q1, 2003, it completed a restructuring of the company that rationalized its product portfolio and substantially reduced its cash burn. IsoTis currently has 100 employees, a product portfolio with several orthobiological medical devices on the market and in development, and is traded under the symbol “ISON” on both the Official Market Segment of Euronext Amsterdam and the Main Board of the Swiss Exchange.
GenSci, the Orthobiologics Technology Company
GenSci Regeneration Sciences, Inc. is a publicly traded company listed on the Toronto Stock Exchange (TSX -"GNS") with corporate headquarters in Toronto, Ontario. GenSci OrthoBiologics, Inc., the company's wholly-owned subsidiary based in Irvine, California, focuses on the research, development, production and distribution of bioimplant products for the orthopedic and spine markets. GenSci OrthoBiologics is the company’s principal operating subsidiary. The company's products are currently sold in over 1,550 hospitals across North America, with a growing international presence throughout Latin America, Europe and Asia. GenSci has 85 employees. Upon conclusion of a infringement lawsuit in December 2001, GenSci filed for Chapter 11 protection to preserve its assets and reorganize its business. Today, the company is poised to emerge from Chapter 11 protection. During its 18 months in Chapter 11, GenSci successfully renewed its product portfolio, replacing the infringing products with new products, maintained its sales levels and initiated a major cost control program. The recent settlement of the patent infringement case now paves the way for emergence from Chapter 11.
Transaction:
The merger will be structured as a Plan of Arrangement pursuant to the Company Act (British Columbia) under which GenSci Regeneration Sciences, Inc. is incorporated. IsoTis will acquire the stock of GenSci OrthoBiologics, Inc. and all other assets relating to GenSci’s orthobiologics business from GenSci Regeneration Sciences Inc., in return for newly issued shares of IsoTis. The new IsoTis shares will be subsequently transferred to GenSci Regeneration Sciences’ current shareholders. The number of newly issued IsoTis shares will be such that IsoTis’ and GenSci’s current shareholders will own 60% and 40%, respectively, of the combined company. IsoTis intends to maintain its public listing on the Zurich and Amsterdam stock markets for the time being. It will review the benefits for the combined shareholders of a North American listing and its timing over the coming months.
The merger is subject to conditions customary to transactions of this type, including, but not limited to, the following conditions:
- Respective shareholder approvals
- Approval of the Supreme Court of British Columbia
- Swiss, Dutch and Canadian stock exchange and other regulatory approvals
- Accuracy of all representations and covenants
- GenSci emergence from Chapter 11
- Limited and short due diligence
The merger is expected to be consummated in the fall of 2003.
Management:
Executive Committee post-merger will consist of (present positions between brackets):
- Jacques R. Essinger, Chief Executive Officer (CEO IsoTis)
- James Hogan, President Europe (COO IsoTis)
- John F. Kay, Head of Research & Development (VP R&D GenSci)
- Douglass Watson, President North America (CEO GenSci)
- Pieter Wolters, Chief Financial Officer (CFO IsoTis)
The IsoTis/GenSci Board of Directors will consist of seven members, with four directors from the existing IsoTis board and three new directors from the current GenSci Board.
Jacques Essinger, Chief Executive Officer, IsoTis S.A. commented: “This merger fulfills our ambition and delivers on the promise we made when Modex and IsoTis merged in Q4 2002 to create a profitable orthobiology company in the short term. GenSci and IsoTis make an excellent fit, strategically and culturally. The business due diligence process has brought both teams together and has fostered mutual respect. The IsoTis team has enormous appreciation for the way in which GenSci management succeeded in turning the company around under very difficult circumstances. Coming out of Chapter 11, GenSci will have a clean slate and remarkably stable sales revenues. Combined with the successfully restructured IsoTis, the combination has ample cash to fuel its innovative product pipeline and its marketing and sales efforts in North America and Europe and, importantly, to aim for profitability in 2005.”
Douglass Watson, President and Chief Executive Officer, GenSci said: “Joining forces with IsoTis will create an extremely well-capitalized and strong player in the orthobiology market, with both the products and the financial strength to become profitable in the short term. By forging this new alliance, the combination will be able to accelerate its business development activities, and to achieve leadership in the orthobiology market on a global scale. We look forward to working as one team with our colleagues from IsoTis, who have demonstrated not only their capacity to merge companies, but also to unite them. Our combined product portfolio covers the near, mid and long term, enabling the new company to present an impressive growth opportunity, continuing well beyond 2005, the year when we anticipate profitability.”
For further information, contact: IsoTis: GenSci:
Hans Herklots Peter Ludlum, Louis G. Plourde Media & investor relations Chief Financial Officer Investor/shareholder relations Tel: +31(0)30 229 5271 Tel: +1 949 855 7154 Tel: + (800) 561-2955 (North America) Fax: +31(0)30 228 0255 E-mail: peterl@Gensciinc.com E-mail: IR@Gensci-regen.com E-mail: investor.relations@isotis.com
Rochat & Partners Citigate First Financial:
Christophe Lamps Floor van Maaren Tel: +41 79 476 26 87 Tel: +31 (0)20 575 40 78 E-mail: clamps@rochat-pr.ch Fax: +31 (0)20 575 40 20 E-mail: floor.vanmaaren@citigateff.nl
(Certain statements in this Press Release are “forward-looking statements”, including those that refer to management’s plans and expectations for future operations, prospects and financial condition. One can identify these forward-looking statements by use of words such as 'strategy,' 'expects,' 'plans,' 'anticipates,' 'believes,' 'will,' 'continues,' 'estimates,' 'intends,' 'projects,' 'goals,' 'targets' and other words of similar meaning. 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 S.A. and GenSci only. 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/GenSci. Actual results could differ materially from current expectations due to a number of risk factors and uncertainties, including but not limited to the timely commencement and success of IsoTis’ and GenSci’s clinical trials and research endeavors, delays in receiving U.S. FDA or other regulatory approvals (a.o. EMEA, CE), market acceptance of the combined Company’s’ products, development of competing therapies and/or technologies, the terms of any future strategic alliances, the need for additional capital, the failure of IsoTis or GenSci shareholders to approve the merger transaction, the inability to obtain, or meet conditions imposed for the required governmental and regulatory approvals and consents, the risk that IsoTis and GenSci will not consummate the transaction, or that implementing the merger may not provide all or any of the benefits projected as it will place significant demands on our management. For a more detailed description of the risk factors and uncertainties affecting IsoTis, refer to IsoTis’ reports filed from time to time with the Swiss Stock Exchange, SWX, Euronext Amsterdam N.V. For a more detailed description of the risk factors and uncertainties affecting GenSci, refer to GenSci’s reports filed from time to time with the Canadian securities regulators, available at www.sedar.com. IsoTis and GenSci are not obligated to update or revise any forward-looking statements, whether as a result of new information or otherwise. This communication shall not constitute an offer to sell or the solicitation of an offer to buy securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.)
1. Backgrounder - Next steps
Over the coming months, GenSci will focus on continuing to build the sales of their three new product lines and emerging from Chapter 11 protection. Specifically, it hopes to obtain from the US Bankruptcy Court approval for the dismissal of GenSci Regeneration Sciences' chapter 11 case in early July and the confirmation of GenSci OrthoBiologics' chapter 11 plan in the fall. Concurrent with the process of emergence from bankruptcy, and subject to appropriate US Bankruptcy Court orders, GenSci will prepare a detailed information circular regarding IsoTis and the combined company for its shareholders, seeking the approval of the British Columbia Supreme Court for the timing of the extraordinary general meeting (“EGM”) of GenSci shareholders to consider the plan of arrangement. IsoTis has entered into support agreements with GenSci shareholders MDS Capital, Canadian Medical Discoveries Fund Limited, and Royal Bank of Canada, pursuant to which they have agreed to vote their combined 26% shares of GenSci in favor of the merger. The support agreements are expressly conditioned on and will become effective only if and upon the US Bankruptcy Court giving its approval for the dismissal of GenSci Regeneration Sciences' chapter 11 case. IsoTis will schedule an extraordinary general meeting to ask its shareholders to approve the issuance of the 29.5 million shares to acquire the GenSci orthobiologics business. In the merger agreement, IsoTis agreed to loan US$5 million to GenSci to enable it to complete its bankruptcy plan in various circumstances, including if IsoTis’ shareholders fail to approve the issuance of the shares to acquire GenSci. In consideration of this and other aspects of the merger agreement, GenSci has granted IsoTis an option to acquire up to 19.9% of GenSci’s issued and outstanding common shares at CDN$0.43 per share. Such option is exercisable if the merger is terminated for various reasons, including GenSci’s receipt of a superior offer and in such circumstances IsoTis can put the option to GenSci for an amount not to exceed approximately CDN$1 million. Should the merger not be consummated and should IsoTis provide the USD$5 million to enable GenSci to emerge from Chapter 11, a warrant for IsoTis to acquire up to approximately 7 million common shares of GenSci at CDN$0.43 per share will become exercisable.
Sequence of events
• June GenSci OrthoBiologics files Revised Disclosure Statement with US Bankruptcy Court
• July Hearings on motion for dismissal of GenSci Regeneration Sciences' chapter 11 and for approval of GenSci OrthoBiologics' Disclosure Statement Hearing
• August Information Circulars to respective shareholders
• Sept - EGM GenSci to approve Arrangement - EGM IsoTis to approve issuing new stock - Chapter 11 Confirmation Hearing - Canadian Court Arrangement Hearing
• Fall 2003 - GenSci emerges from Chapter 11 - IsoTis issues 29.5 million new shares - Merger effective
2. Backgrounder - IsoTis products Orthobiologics OsSatura
With the CE mark it received in February 2003, OsSatura became the first synthetic bone substitute that is approved on the basis of its osteoinductive properties. Developed at IsoTis, OsSatura has all the hallmarks of a smart material, i.e. a material that is designed to set in motion a cascade of events in the musculo-skeletal system that results in bone growth. OsSatura promises accelerated skeletal repair, improved fusion consolidation, and reduces in part or entirely the need for autogenous bone harvesting for certain orthopedic or maxillo-facial indications. OsSatura is composed of approximately 80% hydroxyapatite (HA) and 20% ß-tricalcium phosphate (ß-T CP), similar to human bone in both structure and chemical composition. It is a porous biomaterial featuring interconnected macropores and micropores with an approximate total porosity of 75%. The macropores are responsible for the osteoconduction, whilst the proprietary microporous structure is responsible for the osteoinduction. OsSatura comes in a variety of granule sizes and forms. In addition to the CE mark, IsoTis recently received US FDA 510(k) approval. OsSatura has been launched in the EU in early 2003; the US launch is imminent.
PolyAcive BCP
PolyActive BCP is a fully synthetic bi-layered product under development for particularly difficult to treat knee lesions in which both cartilage and bone are implicated, so-called osteochondral knee defects. Bi-layered PolyActive BCP consists of a small OsSatura cylinder capped by a layer of PolyActive, IsoTis’ proprietary co-polymer system. While OsSatura is designed as a bone substitute, PolyActive can be made to almost the exact specifications of natural cartilage’s flexibility and mechanical strength. It is expected that PolyActive BCP with its combination of unique properties can become a real therapeutic breakthrough in the treatment of osteochondral defects. PolyActive BCP is expected to address a market of potentially US$ 100 million per year.
SynPlug
IsoTis’ SynPlug cement restrictor is used in cemented hip implants. SynPlug is presently being sold in Europe and the USA through a number of large orthopedic companies, as well as through a range of national distributors. SynPlug is made from a proprietary synthetic biomaterial, PolyActive™, that is biodegradable. In the cement restrictor market it successfully competes with synthetic materials that are not biodegradable. The company has superior in vitro pressure resistance data for the product, and an extensive safety file for PolyActive. SynPlug is CE certified and has 510 (k) FDA approval. Under contract of some of its partners, IsoTis also produces other PolyActive small devices.
Skin portfolio Allox
Allox is an off-the-shelf treatment for chronic skin wounds. Chronic skin wounds such as venous ulcers, pressure ulcers, or diabetic foot ulcers, constitute a major public health concern, and are a common cause of morbidity. As an allogeneic, cell-based product, Allox promises to be a considerable step forward compared to existing cell-based product in terms of ease-of-use and storage. Allox consists of growth-arrested skin cells that secrete endogenous growth factors to promote wound healing. Specifically, Allox is composed of a mixture of growth factor producing fibroblasts and keratinocytes in a fibrin spray. Stored in a frozen state, the Allox spray is available off-the-shelf and easy to use. After concluding successful Phase I clinical trials in 2002, IsoTis is currently conducting a multicenter Phase II clinical trial in several countries. The Phase II trial calls for the inclusion of 98 patients, and its results are expected to be available before the end of 2003. This result will subsequently pave the way for IsoTis to seek a partner to bring the program into Phase III clinical trials.
AcuDress & EpiDex
AcuDress is a fibrin-based autologous epidermal sheet which can be applied to burn wounds. EpiDex’ activities in Switzerland have been temporarily put on hold after it became clear that the product would not be reimbursed as of January 1, 2003. The company still maintains a minimal capability to produce EpiDex in order to leverage the Humanitarian Use Device designation received from the US Food and Drug Administration at the end of 2002.
3. Backgrounder - GenSci’s orthobiology products Accell® DBM100,
GenSci’s groundbreaking next-generation technology, is the first and only bone graft putty on the market composed of 100% demineralized bone matrix (DBM). Accell features an exclusive, patent-pending DBM processing technique that does not require an additive carrier, allowing for a 100% bone product with the handling characteristics of DBM putty.
DynaGraft® II has a higher DBM content than the original DynaGraft® while still featuring the excellent handling characteristics favored by surgeons. The transition to DynaGraft II was completed in September 2002, and the Company’s customers have rapidly adopted the new product line. GenSci believes these products to be among the most cost-effective autograft extenders available on the market, when considering osteoinductive performance and price.
OrthoBlast® II, a synergistic combination of DBM and donor-matched cancellous bone in a reverse phase medium features improved handling characteristics. OrthoBlast II replaced the original OrthoBlast™ product line in the market during the fourth quarter of 2002.
4. Backgrounder - Market Overview DBM & SBS: ~US$ 300 million (2002) global market with double digit growth prospects
The bone substitute market is driven by the following factors:
• Demographic changes - the graying of the population
• Expanded indications for bone grafting
• Concerns with autograft due to morbidity and increased costs
• Technological advances resulting in improved product performance Bone substitutes or bone void fillers are used in a wide range of applications in orthopedic and dental surgery.
The bone void filler market is a US$ 300 million market (2002). Demineralized bone matrix products comprise the majority of the market with 2002 sales of US$ 250 million and a CAGR of 10%. Synthetic bone substitutes represent 2002 sales of US$ 50 million but are expected to grow at a CAGR in excess of 20% over the next four years. The choice of either product category is very much a matter of tradition, i.e. dependent on when and where a particular surgeon has been trained. In the US, DBM holds some 80% of the market and synthetic bone substitutes 10%. In Europe the situation is almost the opposite.
Osteochondral Defects: ~50,000 annual cases represent potential US$100 million global market
For osteochondral defects of medium-to-high severity, patients and surgeons currently have very few options for cartilage repair. Those that are available are either limited in effectiveness (surgery) or entail radical changes to the relevant joint (prosthesis). This is a particularly favorable situation for the acceptance and reimbursement of a cartilage substitute that can be tailored almost to the exact specifications of natural cartilage’s flexibility and mechanical strength.
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Announced Conditional Settlement Wtih Osteotech
Irvine, California and Toronto, Ontario, April 21, 2003 - GenSci Regeneration Sciences Inc. (TSX: GNS), The OrthoBiologics Technology Company™, today announced that Osteotech Inc. and GenSci have agreed to settle the various disputes between them subject to certain significant conditions.
The conditions are that: (i) Osteotech receives a letter of credit or other security satisfactory to Osteotech of certain payments over time and (ii) GenSci receives a covenant from Osteotech not to sue GenSci in connection with its newly introduced products. With respect to the letter of credit or other security, GenSci will seek to obtain the security sought by Osteotech. However, there can be no assurance that GenSci will be able to obtain an appropriate security acceptable to Osteotech. There can also be no assurance that the two sides can reach a settlement if GenSci is unable to obtain the security required. With respect to the covenant not to sue, Osteotech is in the process of evaluating GenSci’s position that its new products do not infringe Osteotech’s patents. There is no assurance that Osteotech will agree with GenSci’s position. There can also be no assurance that, if a difference of opinion exists, the two sides can reach a settlement. In addition, there can be no assurance of the time frame required for the two sides to satisfy the conditions detailed above.
If the above two conditions are satisfactorily resolved, terms of settlement include payment of $7.5 million by GenSci to Osteotech. GenSci would recognize the validity of the Osteotech patents at issue in the trial completed in December 2001. GenSci would not be permitted to re-introduce products that are the subject of the pending litigation, which have been withdrawn from the market, and all other litigation between the two parties would be dismissed. Payments to Osteotech include $1 million to be paid on the effective date of GenSci’s plan of reorganization followed by payments of $325,000 per quarter with interest payable at the federal judgment rate, currently 1.3% capped for purposes of future interest payments at 3% per annum. GenSci is seeking a method to secure payment of $5 million of the settlement amount and will provide a subordinated lien on assets to guarantee the remaining $1.5 million in payments.
Finally, the settlement is contingent upon bankruptcy court approval. Terms of the settlement will be incorporated into the terms of a Chapter 11 Plan of Reorganization, which must be confirmed by the bankruptcy court.
GenSci Regeneration Sciences Inc. has established itself as a leader in the rapidly growing orthobiologics market, providing surgeons with biologically based products for bone repair and regeneration. Use of GenSci’s technologies permits less invasive procedures, reduces hospital stays, and improves patient recovery. Through its subsidiary, the Company designs, manufactures and markets biotechnology-based surgical products for orthopedics, neurosurgery and oral maxillofacial surgery. These products can either replace or augment traditional autograft as used in surgical procedures. GenSci is focused on increasing the safety, efficacy, and handling of orthobiologic materials and improving the use of biotechnology combined with materials science in developing products to promote the body’s natural ability to repair and regenerate musculoskeletal tissue.
Certain statements contained herein are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include the timing and success of litigation settlement activities. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors, which may cause the actual results, performance or achievements of the company to be materially different from those expressed or implied. Forward-looking statements involve risks and uncertainties, including, but not limited to, such risks as are described in the company’s annual report.
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Announces Strategic Partnership With AlloSource, Leading Tissue Bank Cooperative
IRVINE, Calif. and TORONTO, March 4, 2003 -- GenSci Regeneration Sciences Inc. (Toronto: GNS), The OrthoBiologics Technology Company(TM), today announced that it has entered into an agreement with AlloSource(R), one of the nation's largest non-profit tissue bank cooperatives, for supply and distribution of key allograft materials.
"The supply of allograft tissue is important to allow GenSci to produce quality products to promote the body's natural ability to repair and regenerate musculoskeletal tissue," said Douglass Watson, President and CEO. "We are proud to add AlloSource as another key strategic partner. This relationship is part of GenSci's evolving strategy to further develop our network of responsible and trusted supply partners and to expand distribution for our surgical products."
In addition to the supply agreement, GenSci OrthoBiologics Inc. will manufacture AlloFuse(TM) DBM Putty and Gel for distribution by AlloSource to its customers. This product will feature GenSci's RPM(TM) technology that provides the excellent handling characteristics favored by surgeons.
AlloSource: AlloSource brings together some of the country's most reputable organ and tissue procurement groups -- Mid-America Transplant Services of St. Louis; Donor Alliance of Denver; The Regional Organ Bank of Illinois in Chicago; and the Lifesharing(TM) Community Organ and Tissue Donation in San Diego. AlloSource and its partners are AATB accredited and represent more than 85 years of combined experience in the tissue banking industry.
GenSci: GenSci Regeneration Sciences Inc. has established itself as a leader in the rapidly growing orthobiologics market, providing surgeons with biologically based products for bone repair and regeneration. Use of GenSci's technologies permits less invasive procedures, reduces hospital stays, and improves patient recovery. Through its subsidiary, the Company designs, manufactures and markets biotechnology-based surgical products for orthopedics, neurosurgery and oral maxillofacial surgery. These products can either replace or augment traditional autograft as used in surgical procedures. GenSci is focused on increasing the safety, efficacy, and handling of orthobiologic materials and improving the use of biotechnology combined with materials science in developing products to promote the body's natural ability to repair and regenerate musculoskeletal tissue.
Certain statements contained herein are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include the timing and success of new business relationships. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors, which may cause the actual results, performance or achievements of the company to be materially different from those expressed or implied. Forward-looking statements involve risks and uncertainties, including, but not limited to, such risks as are described in the company's annual report.
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Provides 2002 Updates on New Product Launches, Financial Performance and Legal Proceedings
Irvine, California and Toronto, Ontario, February 18, 2003 - GenSci Regeneration Sciences Inc. (TSX: GNS), The OrthoBiologics Technology Company™, today announced that during the fiscal year ended December 31, 2002, the Company completely upgraded and expanded its product offering by launching three new product lines effectively replacing former products that were the subject of previously disclosed patent litigation.
Accell™ DBM100, GenSci’s groundbreaking next-generation technology, is the first and only bone graft putty on the market composed of 100% demineralized bone matrix (DBM). Accell features an exclusive, patent pending DBM processing technique that does not require an additive carrier, allowing for a 100% bone product with the handling characteristics of DBM putty.
DynaGraft™ II has a higher DBM content than the original DynaGraft® while still featuring excellent handling characteristics favored by surgeons. The transition was completed in September 2002, and the Company’s customers have rapidly adopted the new product line. GenSci believes these products to be among the most cost effective autograft extenders available on the market, when considering osteoinductive performance and price.
OrthoBlast™ II, a synergistic combination of DBM and cancellous bone in a reverse phase medium features improved handling characteristics and has replaced the original OrthoBlast™ product line in the market during the fourth quarter of 2002.
Douglass Watson, President and CEO stated: “We have successfully transitioned to an entirely new product offering, eliminating original products which were the subject of previously disclosed patent litigation. With Accell, we have raised the technological bar in the field of orthobiologics. An overwhelming majority of our existing accounts have converted to the Company’s new products, and after its first quarter in nationwide distribution, Accell’s revenues are approaching CDN$600,000 per month from almost 300 customers. We have re-invented the company.”
With the transition to DynaGraft II and OrthoBlast II the Company no longer manufactures or distributes any of the products, which were the subject of the patent litigation. The Federal District Court of Los Angeles has yet to enter a judgment relating to the patent litigation trial, which concluded with a jury verdict against the Company in December 2001. The Company still intends to vigorously pursue an appeal as soon as a judgment is filed.
As a result of the jury verdict, and in order to permit an opportunity to appeal, the Company has been operating under the protection of Chapter 11 of the U.S. Bankruptcy Code. On January 15, 2003 the Company submitted its first Plan of Reorganization, and on January 16, 2003 submitted a Disclosure Statement to the United States Bankruptcy Court for the Central District of California. A hearing will be held March 18, 2003 to review and potentially approve the Disclosure Statement, a required step towards presenting the plan of reorganization to creditors.
The Company has maintained normal operations under Chapter 11. Aggressive cost cutting initiatives undertaken since December 2001 and the benefit of operating under Chapter 11 have resulted in GenSci recording its first-ever full year with positive cash flow from operations. In spite of an increasingly competitive market environment and the challenges associated with introducing three new product lines, GenSci has maintained approximately 85% of its revenue base as compared to the prior year. In addition, with a near and medium-term product pipeline and an active product development program, GenSci intends to continue bringing innovative products with leading edge technologies to market.
Copies of GenSci’s Disclosure Statement have been mailed to the United States Trustee’s Office, counsel for the secured creditor(s), counsel to the Official Committee of Unsecured Creditors, and certain parties who have heretofore requested special notice. The Company will furnish to any creditor or interested party a copy of the proposed Disclosure Statement upon written request to Ms. Lori Gauthier, Winthrop Couchot Professional Corporation, 660 Newport Center Drive, 4th Floor, Newport Beach, California 92660.
GenSci Regeneration Sciences Inc. has established itself as a leader in the rapidly growing orthobiologics market, providing surgeons with biologically based products for bone repair and regeneration. Use of GenSci’s technologies permits less invasive procedures, reduces hospital stays, and improves patient recovery. Through its subsidiary, the Company designs, manufactures and markets biotechnology-based surgical products for orthopedics, neurosurgery and oral maxillofacial surgery. These products can either replace or augment traditional autograft surgical procedures. GenSci is focused on increasing the safety, efficacy, and handling of orthobiologic materials and improving the use of biotechnology combined with materials science in developing products to promote the body’s natural ability to repair and regenerate musculoskeletal tissue.
Certain statements contained herein are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include the timing and success of the release of new products, the ultimate results of the appeal of lower court patent litigation decisions and the timing and success of the Company’s efforts to emerge from Chapter 11 protection. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors, which may cause the actual results, performance or achievements of the company to be materially different from those expressed or implied. Forward-looking statements involve risks and uncertainties, including, but not limited to, such risks as are described in the company’s annual report.
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Announces Third Quarter Financial Results
Irvine, California and Toronto, Ontario, October 30, 2002 - GenSci Regeneration Sciences Inc. (TSE: GNS), The Orthobiologics Technology Company™, today announced summary financial results for the third quarter ended September 30, 2002. The complete quarterly financial results will be posted, as soon as available, at www.sedar.com and at www.gensciinc.com. Cash, restricted cash and short-term investments at September 30, 2002 increased 196 percent to $5.3 million compared to $1.8 million at September 30, 2001. This compares to cash, restricted cash and short-term investments of $1.2 million at December 31, 2001.
Revenues for the third quarter ended September 30, 2002 were $8.5 million (US $5.4 million) compared to $9.4 million (US $6.1 million) for the same quarter in 2001. The Company announced a loss of $0.5 million (US $0.3 million), or $0.01 per share, for the third quarter of 2002, a significant improvement compared to a loss of $3.3 million (US $2.2 million), or $0.06 per share, for the third quarter of 2001. The average rate of exchange for the current quarter was CDN $1.56 to US $1.00.
Revenues for the nine months ended September 30, 2002 were $27 million (US $17.2 million) compared to $30.4 million (US $19.8 million) for the same period in 2001. The Company announced a loss of $1.5 million (US $0.9 million), or $0.03 per share, for the first nine months of 2002 compared to a loss of $6.7 million (US $4.3 million), or $0.13 per share, for the same period of 2001.
“We have generated positive cash flow for the third consecutive quarter,” said Douglass Watson, President and CEO. “In addition, we have launched three new product lines this year, including Accell DBM 100™, the only DBM putty made of 100% bone. We now stand ready to move forward and invest in the expansion of our product lines and continue to develop additional new product offerings.”
“The Company is particularly pleased that its subsidiary, GenSci OrthoBiologics, has completely replaced its DynaGraft® line of products in the third quarter and is currently replacing its OrthoBlast™ product line with improved second generation products that no longer contain certain components alleged to infringe other patents,” Mr. Watson said. “The surgical community has responded favorably to these products which have significant improvements, including improved handling characteristics.”
The Company has established itself as a leader in the rapidly growing orthobiologics market, providing surgeons with biologically-based products for bone repair and regeneration. Our products can either replace or augment traditional autograft surgical procedures. This permits less invasive procedures, reduces hospital stays, and improves patient recovery. Through its subsidiaries, the Company designs, manufactures and markets biotechnology-based surgical products for orthopedics, neurosurgery and oral maxillofacial surgery.
Certain statements contained herein are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include the timing and success of new product introductions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors, which may cause the actual results, performance or achievements of the company to be materially different from those expressed or implied. Updates to forward looking statements on new product sales may be withheld for competitive purposes. Forward-looking statements involve risks and uncertainties, particularly the Company’s status under Chapter 11 of the U.S. Bankruptcy Code and including, but not limited to, such risks as are described in the company’s annual report.
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Announces First Quarter Financial Results
IRVINE, Calif., and TORONTO, June 27, 2002 -- GenSci Regeneration
Sciences Inc. (Toronto: GNS), The Orthobiologics Technology Company(TM),
today announced cash, cash equivalents and short-term investments
at March 31, 2002 increased to $4.8 million compared to $4.2 million
at March 31, 2001. This also compares to $1.2 million in cash and
cash equivalents at December 31, 2001.
The Company announced a loss of $544,435 (US $343,772), or $0.01
per share, for the first quarter of 2002 compared to a loss of $2.0
million (US $1.3 million), or $0.04 per share, for the first quarter
of 2001. Revenues for the first quarter ended March 31, 2002 were
$9.7 million (US $6.1 million) compared to $10.6 million (US $6.9
million) for the same quarter in 2001.
"We are different in many ways in 2002 because we have developed
an excellent independent sales network, expanded our international
presence to ten countries in Europe, Asia and Latin America, significantly
reduced payroll and operating expenses and improved our product
pipeline," said Douglass Watson, President and CEO. "We are poised
in 2002 and 2003 to introduce several new products important to
our future success, and expect to emerge from ongoing legal proceedings
as a much stronger, more focused company."
Mr. Watson said he is pleased that the May 2002 launch of DBM100,
the new Accell(TM) family of osteobiologic formulations made from
demineralized bone matrix, is being well accepted by surgeons. "We
expect to see a positive impact from this product in the very short-term,"
GenSci's CEO said.
GenSci Regeneration Sciences Inc. has established itself as a leader
in the rapidly growing orthobiologics market, providing surgeons
with biologically focused products for bone repair and regeneration.
Its products can either replace or augment traditional autograft
surgical procedures. This permits less invasive procedures, reduces
hospital stays, and improves patient recovery. Through its subsidiaries,
the Company designs, manufactures and markets biotechnology-based
surgical products for orthopedics, neurosurgery and oral maxillofacial
surgery.
Certain statements contained herein are forward-looking within
the meaning of the Private Securities Litigation Reform Act of 1995.
These statements include the Company's ability to continue operations
as a going concern, results of the appeal of the adverse jury verdict
and successfully launch new products plus the timing of the release
of future results of operations. Such forward-looking statements
involve known and unknown risks, uncertainties, and other factors,
which may cause the actual results, performance or achievements
of the company to be materially different from those expressed or
implied. Forward-looking statements involve risks and uncertainties,
including, but not limited to, such risks as are described in the
company's annual report.
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Announces Year-End Financial Results
IRVINE, Calif. and TORONTO, June 18, 2002 -- GenSci Regeneration
Sciences Inc. (Toronto: GNS), The Orthobiologics Technology Company(TM),
today announced that revenues for the fiscal year ended December
31, 2001 were $40.4 million (US $26.1 million) compared to $45.8
million (US $30.8 million) for fiscal year 2000.
In February 2001, the Company transitioned from DePuy AcroMed,
Inc., as a sales representative for two of its products, to a newly
formed independent sales representative network, which assumed responsibilities
for the sale of these products. In spite of the changeover and an
increasingly competitive market environment, GenSci's independent
sales network was able to limit the decrease in total revenue to
12%.
GenSci announced a loss of $37.0 million (US $23.5 million), or
$0.70 per share, for the year ended December 31, 2001 compared to
a loss of $7.0 million (US $4.8 million), or $0.15 per share, for
the year ended December 31, 2000. Results are reported in Canadian
dollars with an average annual exchange rate for the year 2001 of
$1.00 Canadian equaling approximately U.S. $0.645.
The loss includes a $23 million (US $14.5 million) accrual for
the previously announced adverse patent litigation jury verdict
that the Company will be appealing. Adding to the loss was the cost
of patent litigation defense, plus investments required to accelerate
market development for GenSci's new products including ongoing research
and development required for its next generation products and technologies.
GenSci reported a loss of $30.3 million, or $0.58 per share, on
revenues of $10.1 million for the fourth quarter ended December
31, 2001 compared to a loss of $4.0 million, or $0.08 per share,
on revenues of $12.6 million for the comparable period in 2000.
GenSci also announced that its annual report for 2001 has been
sent to its shareholders. As previously announced, the commencement
of the year end audit was delayed pending receipt of the required
approval by the United States Bankruptcy Court for the Company's
engagement of its auditors, which approval was not granted until
May 9, 2002. Further to its announcement on June 12, 2002, GenSci
continues to expect that its interim financial statements for the
period ended March 31, 2002, and its Annual Information Form, will
be filed on or before June 28, 2002.
GenSci Regeneration Sciences Inc. has established itself as a leader
in the rapidly growing orthobiologics market, providing surgeons
with biologically based products for bone repair and regeneration.
Its products can either replace or augment traditional autograft
surgical procedures. This permits less invasive procedures, reduces
hospital stays, and improves patient recovery. Through its subsidiaries,
the Company designs, manufactures and markets biotechnology-based
surgical products for orthopedics, neurosurgery and oral maxillofacial
surgery.
Certain statements contained herein are forward-looking within
the meaning of the Private Securities Litigation Reform Act of 1995.
These statements include the Company's ability to continue operations
as a going concern, results of the appeal of the adverse jury verdict
and successfully launch new products plus the timing of the release
of future results of operations. Such forward-looking statements
involve known and unknown risks, uncertainties, and other factors,
which may cause the actual results, performance or achievements
of the company to be materially different from those expressed or
implied. Forward-looking statements involve risks and uncertainties,
including, but not limited to, such risks as are described in the
company's annual report.
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Delay in Filing Annual Financial Statements
Irvine, California and Toronto, Ontario, May 27, 2002 - Further
to news announced May 22, 2002, GenSci Regeneration Sciences Inc.
(TSE: GNS) confirms that its comparative financial statements for
the fiscal year ended December 31, 2001 were not filed on or before
May 20, 2002, being 140 days after the end of the Company’s last
fiscal year, and advises that there will be a delay in the filing
of its interim financial statements for the period ended March 31,
2002 on or prior to May 30, 2002, which is 60 days after the end
of the Company’s last fiscal quarter, all as required by applicable
securities laws in the jurisdictions in which the Company is a reporting
issuer. The Company further confirms that its Annual Information
Form (“AIF”) and Management’s Discussion and Analysis (“MD&A”) were
not filed on or before May 20, 2002, being 140 days after the end
of the Company’s last fiscal year, as required by Ontario Securities
Commission (“OSC”) Rule 51-501. The Company is issuing this news
release further to the requirements of OSC Policy 57-603.
As previously announced, the commencement of the audit was delayed
pending receipt of the required approval by the United States Bankruptcy
Court for the Company’s engagement of its auditors, which approval
was not granted until May 9, 2002. The audit is currently proceeding
and the Company anticipates that the annual and interim financial
statements and its AIF and MD&A will be prepared and filed on or
before June 17, 2002. If the Company fails to file its annual financial
statements, AIF and MD&A by July 20, 2002 or its interim financial
statements by July 30, 2002, a cease trade order may be imposed
by the applicable securities commissions requiring that all trading
in securities of the Company cease for such period specified in
the order. The Company understands that during the period of time
that the annual and interim financial statements remain outstanding,
the insiders of the Company will be subject to an OSC cease trade
order, prohibiting such insiders from trading securities of the
Company.
The Company continues to operate with the protection of Chapter
11 of the U.S. Bankruptcy Code. As the Company is required to file
future reports with the Office of the U.S. Trustee, it will file
the same information with the applicable securities commissions.
The Company intends to satisfy the provisions of the alternate information
guidelines of OSC Policy 57-603 for so long as it remains in default
of the financial statement filing requirements of applicable securities
laws.
GenSci Regeneration Sciences Inc. has established itself as a leader
in the rapidly growing orthobiologics market, providing surgeons
with biologically based products for bone repair and regeneration.
Its products can either replace or augment traditional autograft
surgical procedures. This permits less invasive procedures, reduces
hospital stays, and improves patient recovery. Through its subsidiaries,
the Company designs, manufactures and markets biotechnology-based
surgical products for orthopedics, neurosurgery and oral maxillofacial
surgery.
Certain statements contained herein are forward-looking within
the meaning of the Private Securities Litigation Reform Act of 1995.
These statements include the timing of the release of future results
of operations. Such forward-looking statements involve known and
unknown risks, uncertainties, and other factors, which may cause
the actual results, performance or achievements of the company to
be materially different from those expressed or implied. Forward-looking
statements involve risks and uncertainties, including, but not limited
to, such risks as are described in the company’s annual report.
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Delayed Audit Triggers Late Filing
Irvine, California and Toronto, Ontario, May 22, 2002 - GenSci
Regeneration Sciences Inc. (TSE: GNS) today announced a delay beyond
the May 21, 2002 deadline for filing its annual report and financial
statements for the year ending December 31, 2001. The postponement
is due to a delay in the commencement of the Company’s year-end
audit. In order to reorganize, the Company is operating under Chapter
11 protection of the U.S. Bankruptcy Code. Under Chapter 11 procedures
the Court must approve the employment of all attorneys and auditors
working on behalf of the Company. The Company’s auditors were approved
on May 9, 2002. The Company’s results for the year ending December
31, 2001 will be announced and financial statements filed immediately
upon completion of the audit. First quarter 2002 results, due May
30, 2002, will also be delayed, for the same reasons.
GenSci Regeneration Sciences Inc. has established itself as a leader
in the rapidly growing orthobiologics market, providing surgeons
with biologically based products for bone repair and regeneration.
Its products can either replace or augment traditional autograft
surgical procedures. This permits less invasive procedures, reduces
hospital stays, and improves patient recovery. Through its subsidiaries,
the Company designs, manufactures and markets biotechnology-based
surgical products for orthopedics, neurosurgery and oral maxillofacial
surgery.
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Signs Two-Year Contract With HealthTrust Purchasing Group
Irvine, California, February 13, 2002-- GenSci OrthoBiologics,
Inc. (GenSci), a wholly-owned subsidiary of GenSci Regeneration
Sciences Inc. (TSE: GNS), today announced the signing of a two-year
agreement with HealthTrust Purchasing Group, L.P. (HPG), one of
America’s leading membership-based healthcare group purchasing organizations.
HPG has a contracting volume totaling approximately (U.S.) $5 billion
and a current membership in excess of 800 facilities.
Under the agreement, which took effect at the beginning of this
year, GenSci will offer its entire line of proprietary products
for distribution at a contracted fee to HPG’s nationwide network
of hospitals, clinics and surgery centers. The contract also provides
for the inclusion of future technology products or enhancements
as they are introduced into the market, such as Accell™ DBM 100,
the first product in a new line of osteoinductive putties, scheduled
for release in the Spring of 2002. "We are pleased to play a role
in meeting the needs of HPG’s patients and supporting HPG's mission
to provide high-quality, cost-effective surgical materials, supplies
and services for its patients and physicians,'' said Douglass C.
Watson, GenSci’s President and Chief Executive Officer. “This agreement
further benefits HPG member hospitals currently utilizing our products
and gives our distribution network the opportunity to introduce
GenSci’s biologically based surgical products to HPG accounts not
yet familiar with GenSci’s superior, leading-edge technologies.
We look forward to building on this relationship for many years
to come.”
Established in May 1999, HealthTrust Purchasing Group negotiates
with the nation's leading suppliers to provide its member facilities
with only the highest quality supplies, equipment and services at
the most competitive prices possible. Its member facilities include
Acumen Healthcare, ALTA Healthcare System, American MedTrust, Ardent
Health Services, Essent, HCA, Health Management Associates (HMA),
LifePoint Hospitals, PresGar Imaging, Province Healthcare, Quorum
Health Resources (QHR), SunLink Healthcare Corporation, Triad Hospitals,
and Vanguard Health Systems.
GenSci Regeneration Sciences Inc. has established itself as a leader
in the rapidly growing orthobiologics market, providing surgeons
with biologically based products for bone repair and regeneration.
Its products can either replace or augment traditional autograft
surgical procedures. This permits less invasive procedures, reduces
hospital stays, and improves patient recovery. Through its subsidiaries,
the Company designs, manufactures and markets biotechnology-based
surgical products for orthopedics, neurosurgery and oral maxillofacial
surgery.
Certain statements contained herein are forward-looking within
the meaning of the Private Securities Litigation Reform Act of 1995.
These statements include the future outcomes of marketing initiatives.
Such forward-looking statements involve known and unknown risks,
uncertainties, and other factors, which may cause the actual results,
performance or achievements of the company to be materially different
from those expressed or implied. Forward-looking statements involve
risks and uncertainties, including, but not limited to, such risks
as are described in the company’s annual report.
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Announces Sale of Osteopharm
Toronto, Ontario, January 7, 2002 - GenSci Regeneration Sciences
Inc. (TSE: GNS) today announced the sale of its wholly owned subsidiary,
Osteopharm Inc., to Charterbridge Holdings Ltd, as part of a previously
announced strategy to focus on its primary orthobiologics business.
Proceeds from this December 15, 2001 transaction include cash, a
note and a royalty interest in future Osteopharm products. GenSci
has retained an exclusive license to use Osteopharm’s proprietary
technology for use in developing products for surgical applications.
Osteopharm Inc. is located in Oakville, Ontario and is focused
on the commercialization of a series of anabolic peptide compounds
for the potential diagnosis and treatment of osteoporosis.
GenSci Regeneration Sciences Inc. is focused on developing novel
approaches to bone repair and regeneration and markets biotechnology
products in the areas of orthopedics, neurosurgery, and oral maxillofacial
surgery.
Certain statements contained herein are forward-looking within
the meaning of the Private Securities Litigation Reform Act of 1995.
These statements include the future results of intellectual property
development. Such forward-looking statements involve known and unknown
risks, uncertainties, and other factors, which may cause the actual
results, performance or achievements of the company to be materially
different from those expressed or implied. Forward-looking statements
involve risks and uncertainties, including, but not limited to,
such risks as are described in the company’s annual report.
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