surf1944
15 years ago
Johnson & Johnson Announces Definitive Agreement to Acquire Omrix
Monday November 24, 6:30 am ET
Omrix's Biopharmaceutical Expertise Complements ETHICON's Industry-Leading Surgery Portfolio
NEW BRUNSWICK, N.J. and NEW YORK, Nov. 24 /PRNewswire-FirstCall/ -- Johnson & Johnson (NYSE: JNJ - News) and Omrix Biopharmaceuticals, Inc. (Nasdaq: OMRI - News), a fully integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, today announced a definitive agreement whereby Omrix will be acquired for approximately $438 million in a cash tender offer. Omrix is expected to operate as a stand-alone entity reporting through ETHICON, Inc., a Johnson & Johnson company and leading provider of suture, mesh, hemostats and other products for a wide range of surgical procedures.
The acquisition of Omrix would provide ETHICON with an opportunity to strengthen its presence in active, biologic-based hemostats and convergent products for various surgical applications. ETHICON currently has exclusive distribution rights in the U.S. and the European Union for EVITHROM(TM) Thrombin Topical (Human) and EVICEL(TM) Fibrin Sealant (Human), two active, biologic-based hemostats manufactured by Omrix. ETHICON and Omrix are also partnering on a Fibrin Pad product candidate, currently in Phase II clinical trials, as an adjunct to control mild to moderate soft tissue bleeding.
Under the terms of the agreement, Johnson & Johnson will commence a tender offer to purchase all outstanding shares of Omrix at $25.00 per share, which is expected to close by the end of December 2008. The tender offer is conditioned on the tender of a majority of the outstanding shares of Omrix's common stock on a fully diluted basis. The closing is conditioned on Israeli antitrust clearance and other customary closing conditions. The $358 million estimated net value of the transaction is based on Omrix's 17.5 million fully diluted shares outstanding, net of estimated cash on hand at time of closing. The boards of directors of Johnson & Johnson and Omrix have approved the transaction. In addition, Robert Taub, Omrix's Founder and Chief Executive Officer, and entities controlled by Robert Taub, have agreed to tender approximately 16% of Omrix's outstanding shares in the tender offer.
Alex Gorsky, Company Group Chairman for Johnson & Johnson with responsibility for the ETHICON business worldwide, said, "Our partnership with Omrix has already expanded our capacity to provide innovative, next generation products that raise the standard of surgical care. We believe this transaction will further enhance our efforts to bring new, science-based products to patients and the healthcare professionals who treat them."
"We are delighted to announce this transaction, which combines Omrix's expertise in developing innovative biological products with ETHICON's commercialization expertise and global reach. We believe this merger is in the best interest of Omrix's shareholders, customers and employees," commented Robert Taub. "Omrix and ETHICON have enjoyed a solid partnership for the past five years. As a formally unified entity, our successful distribution and development agreements will evolve into an even more attractive long-term growth strategy. Omrix's Israeli-based manufacturing and research & development expertise will be strengthened by the long-term stability and integration that this merger will create."
Assuming this transaction closes in 2008, Johnson & Johnson is expected to incur an estimated one-time, after-tax charge of approximately $120 million reflecting the write-off of in-process research and development charges (IPR&D). The acquisition is expected to be breakeven to slightly dilutive to Johnson & Johnson's earnings per share in 2009.
surf1944
16 years ago
Omrix Biopharmaceuticals Announces Second Quarter 2008 Financial Results
Monday August 11, 4:10 pm ET
NEW YORK--(BUSINESS WIRE)--Omrix Biopharmaceuticals, Inc. (“Omrix” or the “Company”) (NASDAQ: OMRI - News), a fully-integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, today announced financial results for the second quarter ended June 30, 2008:
* Second quarter 2008 total revenues were $19.2 million, a 71% increase, from $11.2 million in the second quarter of 2007.
* Second quarter 2008 product sales were $18.2 million, a 100% increase, from $9.1 million in the second quarter of 2007.
* Second quarter 2008 biosurgical product sales were $8.4 million, a 155% increase, from $3.3 million in the second quarter of 2007.
* Second quarter 2008 passive immunotherapy product sales were $7.9 million, a 36% increase, from $5.8 million in the second quarter of 2007.
* Second quarter 2008 passive immunotherapy byproduct sales were $1.9 million. There were no such sales in the second quarter of 2007.
* Second quarter 2008 net income was $3.0 million, or $0.17 per share on a diluted basis, from $1.5 million, or $0.09 per share on a diluted basis, in the second quarter of 2007.
Recent Events:
* Appointed Asaf Alperovitz as Chief Financial Officer effective October 23, 2008. Since June 2005, Mr. Alperovitz has been Chief Financial Officer of Tefron Ltd. In his position as CFO of Omrix, Mr. Alperovitz will be responsible for finance, strategic, operational and financial planning, investor relations and information technology systems.
* Initiated a Phase II Clinical Trial in Israel for the Fibrin Pad (formerly Fibrin Patch) in severe bleeding. This is the first clinical trial that will evaluate the Fibrin Pad's performance in surgery where severe bleeding is present and the product is applied directly onto a solid organ. The Fibrin Pad is the Company’s breakthrough convergence product candidate. The Fibrin Pad, comprised of biological components in a biodegradable matrix, is designed for the management and rapid control of mild, moderate and severe bleeding.
* Received a positive opinion for EVICEL™ Fibrin Sealant (Human) from the Committee for Medicinal Products for Human Use (CHMP). Omrix is seeking approval to market Evicel in Europe for the improvement of hemostasis in surgery. CHMP is the scientific committee of the European Medicines Agency (EMEA) and is responsible for reviewing medicinal product applications for quality, safety and efficacy. The CHMP's positive opinion for Evicel will now be forwarded to the European Commission for marketing authorization
“We are pleased to report a record quarter of biosurgery sales. Our biosurgery marketing partner ETHICON, INC., a Johnson & Johnson company, confirms that Evicel continues to increase penetration in the fibrin sealant market by both the addition of new customers and increased sales to repeat customers,” stated Robert Taub, Chief Executive Officer. “We believe that our overall operational and financial results demonstrate our ongoing commitment to executing our business strategy. We continue to develop innovative partnered and non-partnered biosurgical products and deliver solid revenue growth and profitability.”
Second Quarter 2008 Financial Results
Total revenues for the second quarter of 2008 increased to $19.2 million, a 71% increase, from $11.2 million in the second quarter of 2007.
Total product sales for the second quarter of 2008 increased to $18.2 million ($8.4 million from biosurgery products, $7.9 million from immunotherapy products and $1.9 million from immunotherapy byproducts), a 100% increase from $9.1 million ($3.3 million from biosurgery products, $5.8 million from immunotherapy products and $0.0 from immunotherapy byproducts) in the comparable quarter in 2007. Biosurgery product sales increased 155% primarily due to increased unit sales and unit price of Evicel. Evithrom end-user sales continue to grow moderately. However, in the second quarter of 2008 approximately 40% of the customers who purchased Evithrom were first time buyers.
Total product sales include $1.9 million of immunotherapy byproduct sales. Omrix has entered into a three-year agreement to supply this byproduct, which previously had been discarded. Sales of this byproduct amounted to $1.4 million in the second quarter of 2008 and $0.7 million in the first quarter of 2008. Second quarter 2008 byproduct sales also include a $0.5 million one-time sale of another byproduct to the same party. Excluding byproduct sales, total product sales would have increased to $16.3 million, or 80%, from $9.1 million in the comparable quarter in 2007.
Gross profit for the second quarter of 2008 was $8.0 million, or 42% of total revenues, compared to $4.2 million, or 38% of total revenues, in the corresponding quarter of 2007. Gross profit was favorably impacted by increased sales volumes.
Research and development, including clinical and regulatory, expenses increased by 12% to $1.6 million in the second quarter of 2008 from $1.4 million in the second quarter of 2007. This increase is driven by an increase in personnel and in expenses mainly related to the development of Adhexil, the Company’s adhesion prevention product candidate, and other non-partnered products. The Company expects research and development, including clinical and regulatory, expenses to continue at higher than historical levels as it increases the development of non-partnered products, balancing delivering short-term results with investments for long-term growth.
Selling, marketing, general and administrative expenses, or SG&A, in the second quarter of 2008 increased to $4.2 million, a 35% increase, compared to $3.1 million in the second quarter of 2007. Second quarter 2008 SG&A expenses include a non-recurring expense of $0.5 million related to the relocation of the Company’s U.S. office, in the third quarter, to lower cost facilities. Excluding this non-recurring expense, SG&A in the second quarter of 2008 would have been $3.7 million, or 19% of total revenues and a 20% increase, when compared to $3.1 million in the second quarter of 2007.
Financial income, net includes interest income, banking charges and amounts generated by exchange rate fluctuations. In the second quarter of 2008, financial income, net amounted to $0.9 million, including interest income of $0.6 million and foreign exchange gains of $0.3 million compared to a total of $1.0 million, including interest income of $1.1 million and exchange losses of $0.1 million in the second quarter of 2007.
Other income in the second quarter of 2008 includes $0.2 million of non–recurring sales, which represent a gain on the sale of excess plasma. Other income in the second quarter of 2007 includes $0.9 million of non–recurring sales, which represent a gain from the termination of an agreement with a distributor.
In 2008, Omrix’ Israeli subsidiary began to accrue income taxes as it has fully utilized all of its tax-loss carry-forwards. As it also receives tax benefits under the approved and privileged enterprise status and as a “foreign investors’ company”, a significant portion of its taxable income enjoys a reduced tax rate in 2008. As a result, in 2008, the Company expects its effective income tax rate to be approximately 10%.
Net income for the second quarter of 2008 was $3.0 million, or $0.17 per share on a diluted basis, versus $1.5 million, or $0.09 per share on a diluted basis, in the second quarter of 2007.
Cash, cash equivalents and short-term investments totaled $83.1 million. As of June 30, 2008, the Company had 17,115,398 shares of common stock outstanding.
Full Year 2008 Guidance
The Company is increasing its total product sales and immunotherapy sales guidance to reflect the addition of its immunotherapy byproduct sales. Thus, the Company is providing the following guidance:
* Total product sales ranging from approximately $68.0 million to $71.0 million from $64.0 million to $67.0 million for the full year 2008;
* Biosurgical product sales growth of approximately 75% in 2008 when compared to 2007; and
* Immunotherapy product and byproduct sales of approximately $34.0 to $35.0 million for the full year 2008.
Third Quarter 2008 Guidance
The Company is providing the following guidance:
* Biosurgery product sales of approximately $8.4 million for the third quarter of 2008.
The Company’s product sales guidance for 2008 is based on the following key assumptions:
* Current biosurgery sales forecasts provided by Omrix’ marketing partner, ETHICON, INC., a Johnson & Johnson Company;
* No product or business acquisitions; and
* No product sales from vaccinia immunoglobulin (VIG).
Upcoming Milestones
The Company anticipates the following milestones in the remainder of 2008:
* Obtain EMEA approval of Evicel as a supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of hemostasis and as suture support for hemostasis in vascular surgery;
* Complete enrollment of 130 patients in the U.S. mild to moderate Phase II clinical trial of the Fibrin Pad in late 2008/early 2009;
* Announce data from the Phase I/II clinical trial of Adhexil; and
* Obtain approval of Hepatitis B Immunoglobulin (HBIG) in Sweden.
Conference Call Information
Omrix will host a conference call to discuss these financial results today, Monday, August 11, 2008, at 4:30 p.m. Eastern Time. To access the live telephonic broadcast, U.S. callers should dial (800) 299-7635; international callers may dial (617) 786-2901 and provide confirmation code 60144306. A live audio webcast of the call will be available via the Investor Relations' section of the Company's website at www.omrix.com. Participants are urged to log on to the website 15 minutes prior to the scheduled start time to download and install any necessary software.
An audio replay of the conference call will be available from 6:30 pm ET on Monday, August 11, 2008 through Monday, August 18, 2008 by dialing (888) 286-8010 from the U.S. or (617) 801-6888 when calling internationally, and entering confirmation code 73005754. The audio webcast will be available on the company's website, www.omrix.com, for 30 days. The financial results press release will also be accessible on the company's website at www.omrix.com.
http://biz.yahoo.com/bw/080811/20080811006244.html?.v=1
surf's up......crikey
surf1944
16 years ago
Omrix Biopharmaceuticals Initiates Phase II Clinical Trial in Israel for Fibrin Pad Product Candidate
Wednesday July 2, 1:02 pm ET
NEW YORK--(BUSINESS WIRE)--Omrix Biopharmaceuticals, Inc. (“Omrix” or the “Company”) (NASDAQ: OMRI - News) announced today that it has enrolled its first patient in a Phase II clinical trial in Israel for its Fibrin Pad product candidate. This is the first clinical trial that will evaluate the Fibrin Pad’s performance in surgery where severe bleeding is present and the product is applied directly onto a solid organ. The Phase II clinical trial in Israel is being conducted simultaneously with the Phase II clinical trial in the U.S., which commenced on March 27, 2008 and is under an Investigational New Drug (IND) application that was filed with the Food and Drug Administration (FDA) in November 2007.
The Fibrin Pad is a breakthrough convergence product candidate comprised of biological components in a biodegradable device. In collaboration with ETHICON, INC., a Johnson & Johnson company, the Fibrin Pad is being developed for the management and rapid control of mild, moderate and severe bleeding.
About the Phase II Clinical Trials in the US and Israel
The US trial is a randomized, controlled clinical study that will evaluate the superiority of the Fibrin Pad when compared to SURGICEL® Absorbable Hemostat. In this study, the Fibrin Pad is applied to soft tissue as an adjunct to hemostasis in mild to moderate bleeding. The Israeli trial is a randomized, controlled clinical study that will evaluate the safety and efficacy of the Fibrin Pad when compared to the standard of care, defined as suture, cautery, ligature or passive hemostats. In this study, the Fibrin Pad is applied directly onto the solid organ in severe bleeding. The trials also differ in the number of patients to be enrolled (up to 210 patients in the US trial and up to 30 patients in the Israeli trial).
Phase II Clinical Trial Design in Israel
This study will enroll up to 30 patients undergoing partial nephrectomy, who will be randomized into two treatment arms: (1) 10 patients will be treated in accordance with the standard of care; and (2) 20 patients will be treated with the Fibrin Pad applied directly onto the solid organ. The endpoints will measure both safety and efficacy. The primary efficacy endpoint will measure time to hemostasis at 10 minutes and if any re-bleeding occurs during a subsequent 6 minute observation period. The clinical trial has a 1 month follow-up period.
About Omrix Biopharmaceuticals, Inc.
Omrix is a fully integrated biopharmaceutical company that develops, manufactures and markets protein-based biosurgery and passive immunotherapy products. Omrix' biosurgery product line includes products and product candidates that are used for the control of bleeding, or hemostasis, and other surgical applications. The Company's passive immunotherapy product line includes antibody-rich products and product candidates for the treatment of immune deficiencies, infectious diseases and potential biodefense applications. For more information, please visit www.omrix.com.
surf1944
16 years ago
Omrix Biopharmaceuticals Announces First Quarter 2008 Financial Results
Friday May 9, 6:00 am ET
NEW YORK--(BUSINESS WIRE)--Omrix Biopharmaceuticals, Inc. (“Omrix” or the “Company”) (NASDAQ: OMRI - News), a fully-integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, today announced financial results for the first quarter ended March 31, 2008:
* First quarter 2008 total revenues were $17.7 million, a 25% increase, from $14.2 million in the first quarter of 2007.
* First quarter 2008 product sales were $15.1 million, a 34% increase, from $11.3 million in the first quarter of 2007.
* First quarter 2008 biosurgical product sales were $6.1 million, a 120% increase, versus $2.8 million in the first quarter of 2007.
* First quarter 2008 passive immunotherapy product sales were $9.0 million, a 6% increase, versus $8.5 million in the first quarter of 2007.
* First quarter 2008 net income was $2.1 million, or $0.12 per share on a diluted basis, versus $3.4 million, or $0.20 per share on a diluted basis, in the first quarter of 2007.
Recent Events:
* Received Food and Drug Administration, or FDA, approval to market the Company’s liquid fibrin sealant, Evicel™, with general hemostasis in surgery indication on January 10, 2008; and
* Initiated a Phase II Clinical Trial in mild to moderate bleeding for the Fibrin Patch, the Company’s breakthrough convergence product candidate. The Fibrin Patch, comprised of biological components in a biodegradable device, is designed for the management and rapid control of mild, moderate and severe bleeding.
“Our biosurgery business is a key driver for 2008 and we continue to be confident in our prior guidance of growing this business by approximately 75% when compared to 2007,” stated Robert Taub, Chief Executive Officer. “Our biosurgery marketing partner ETHICON, INC., a Johnson & Johnson company, confirms that Evicel continues to increase penetration in the fibrin sealant market by both the addition of new customers and increased sales to repeat customers.”
First Quarter 2008 Financial Results
Total revenues for the first quarter of 2008 increased to $17.7 million, a 25% increase, from $14.2 million in the first quarter of 2007.
Total product sales for the first quarter of 2008 increased to $15.1 million, a 34% increase ($6.1 million from biosurgery products and $9.0 million from immunotherapy products), from $11.3 million ($2.8 million from biosurgery products and $8.5 million from immunotherapy products) in the comparable quarter in 2007. The biosurgery product sales increase of 120% is principally attributable to increased unit sales of Evicel. Evithrom sales continue moderate growth with approximately 60% of sales in the first quarter of 2008 attributable to new, first time accounts. Immunotherapy product sales include $0.7 million of Vaccinia Immunoglobulin, or VIG, deferred revenues.
Gross profit for the first quarter of 2008 was $7.6 million, or 43% of total revenues, compared to $5.4 million, or 38% of total revenues, in the corresponding quarter of 2007. Excluding the recognition of deferred VIG revenues, gross profit on product sales improved from 37% in the first quarter of 2007 to 41% in the first quarter of 2008. Gross profit was favorably impacted by increased sales volume.
Research and development, including clinical and regulatory expenses, increased by 152% to $2.0 million in the first quarter of 2008 from $0.8 million in the first quarter of 2007. This difference is driven by an increase in research and development personnel and in expenses mainly related to the development of Adhexil, the Company’s abdominal adhesion prevention product candidate. The Company is optimistic about the prospects for Adhexil, which it is developing without third party collaboration, and the Company expects to initiate discussions with prospective partners in the second half of 2008 for the distribution of Adhexil, when it is commercially available. The Company additionally expects research and development expenses to continue at higher than historical levels as it increases the development of non-partnered products, balancing delivering short-term results with investments for long-term growth.
Selling, marketing, general and administrative expenses, or SG&A, in the first quarter of 2008 increased to $4.8 million, a 98% increase, compared to $2.4 million in the first quarter of 2007. The difference is due to increases in salaries, rent, consulting, legal and patent fees. First quarter 2008 expenses include $0.3 million of non-recurring severance paid to our former Chief Financial Officer. The Company expects its infrastructure and personnel investments to continue at approximately the same level for the remainder of 2008, as it positions itself for the development and introduction of new products, the introduction of current products in new markets, and related revenue growth. A modest reduction in SG&A expenses is anticipated, as a percentage of revenues, beginning in 2009.
Financial income includes interest income, banking charges and amounts generated by exchange rate fluctuations. In the first quarter of 2008, financial income includes interest income of $0.8 million and foreign exchange gains of $0.6 million compared to $1.1 million and $0.1 million, respectively, for the three months ended March 31, 2007.
In 2008, Omrix’ Israeli subsidiary will begin to pay income taxes as it has fully utilized all of its tax-loss carry-forwards. As it also receives tax benefits under the approved and privileged enterprise status and as a “foreign investors’ company”, a significant portion of its taxable income enjoys a reduced tax rate in 2008. As a result, in 2008 the Company expects its effective income tax rate to be approximately 10%.
Net income for the first quarter of 2008 was $2.1 million, or $0.12 per share on a diluted basis, versus $3.4 million, or $0.20 per share on a diluted basis, in the first quarter of 2007.
As of March 31, 2008, the Company had 17,115,681 shares of common stock outstanding. Cash, cash equivalents and short-term investments totaled $82.5 million.
Full Year 2008 Guidance and Upcoming Milestones
http://biz.yahoo.com/bw/080509/20080509005193.html?.v=1
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mlkrborn
16 years ago
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