AEterna Zentaris, Incorporated
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AEterna Zentaris "buy," target price reduced
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NEW YORK, June 3 (newratings.com) - Analysts at Canaccord Adams reiterate their "buy" rating on AEterna Zentaris Inc (ticker: AEZS). The target price has been reduced from $3.20 to $2.65. [more]
http://www.newratings.com/en/main/company_headline.m?id=1755879
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AEZS: Sale of Rights for Cetrotide(R) to Cowen Healthcare - Zibb.com
www.zibb.com
By Fain Hughes, fhughes@knobias.com AEterna Zentaris Inc. (AEZS) has signed a definitive agreement to sell to Cowen Healthcare Royalty Partners, L.P. ("CHRP") its rights to royalties on future sales of Cetrotide(R) covered by its license agreement with Merck Serono. The license agreement
http://www.zibb.com/article/4362801/AEZS+Sale+of+Rights+for+Cetrotide+R+to+Cowen+Healthcare
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AEterna Zentaris Reports Third Quarter 2008 Financial and Operating Results - Zibb.com
QUEBEC CITY, Nov 13, 2008 /PRNewswire-FirstCall via COMTEX/ --
All amounts are in U.S. dollars
AEterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ), a global biopharmaceutical company focused on endocrinology and oncology, today reported financial and operating results for the third quarter ended September 30, 2008.
Third Quarter 2008 Highlights
- Appointment on September 1, 2008, of Juergen Engel, Ph.D. as President
and CEO of AEterna Zentaris, replacing Juergen Ernst who had been
acting as Interim President and CEO since April 2008. Mr. Ernst, the
former Chairman of the Company, was appointed Executive Chairman
effective September 1, 2008;
- Completion of patient recruitment for the second efficacy trial of the
Phase 3 program in benign prostatic hyperplasia (BPH) with lead
compound, cetrorelix;
- Start of second stage of recruitment for the Phase 2 trial in ovarian
cancer with AEZS-108. The trial is part of a Phase 2 program in
gynaecological cancers which will include up to 82 women;
- Signing of a license and cooperation agreement for the
commercialization of cetrorelix in BPH, with Handok Pharmaceuticals
Co., Ltd. (Handok) for the Korean market. Subsequent to quarter end,
signing of another agreement with Handok for the commercialization of
ozarelix in BPH for the Korean market; and
- Recovery of worldwide rights from Ardana plc (LSE: ARA) for the Growth
Hormone Secretagogue (GHS) compound, AEZS-130. Future development
options are currently being evaluated for the use of this compound in
growth hormone deficiencies.
Subsequent to Quarter-End
On November 11, 2008, AEterna Zentaris signed a definitive agreement to sell to Cowen Healthcare Royalty Partners, L.P. ("CHRP") its rights to royalties on future sales of Cetrotide(R) covered by its license agreement with Merck Serono. The license agreement between AEterna Zentaris and Merck Serono was signed in 2000 and granted Merck Serono exclusive rights to market, distribute and sell Cetrotide worldwide, with the exception of Japan, in the field of in vitro fertilization. On closing, AEterna Zentaris will receive $52.5 million from CHRP. In addition, contingent on 2010 net sales of Cetrotide(R) reaching a specified level, AEterna Zentaris would receive an additional payment of $2.5 million from CHRP.
Under the terms of the agreement, if cetrorelix which is currently in Phase 3 clinical trials for the treatment of benign prostatic hyperplasia, is approved for sale by the European regulatory authorities in an indication other than in vitro fertilization, AEterna Zentaris has agreed to make a one-time cash payment to CHRP for an amount ranging from $5 million up to a maximum of $15 million. The amount which would be due to CHRP will be higher the earlier the product receives European regulatory approval.
"We are very pleased with the Cowen Healthcare Royalty Partners transaction for Cetrotide(R) which is in line with our strategy of generating non-dilutive financing. With this transaction, we strengthened our financial position to focus on the development of cetrorelix in BPH, while pursuing partnership opportunities for its future commercialization," said Juergen Engel, Ph.D., President and Chief Executive Officer of AEterna Zentaris. "At the drug development level, both our Phase 3 program in BPH with cetrorelix, and our Phase 2 program with our lead oncology compound, AEZS-108 in ovarian and endometrial cancer, met their recruitment goals as scheduled and remain on track. First results for cetrorelix in BPH are still expected in the third quarter of 2009, while those for AEZS-108 should be disclosed in the next few months."
CONSOLIDATED RESULTS FOR THE THIRD QUARTER ENDED SEPTEMBER 30, 2008
Consolidated sales and royalties increased to $8.6 million for the three-month period ended September 30, 2008, compared to $7.4 million for the same period in 2007. The increase in sales and royalties for the three-month period ended September 30, 2008 compared to the same period last year is related primarily to additional sales of Cetrotide(R), partly offset by the exclusion of sales from Impavido(R) in the third quarter of 2008.
License fees revenues decreased to $2.4 million for the three-month period ended September 30, 2008 compared to $3.7 million for the same period in 2007. The decrease for the three-month period ended September 30, 2008, compared to the same period in 2007, is mainly attributable to a milestone payment received in 2007 from Ardana plc.
Consolidated R&D costs, net of tax credits and grants were $13.9 million for the three-month period ended September 30, 2008 compared to $9.8 million for the same period in 2007. Additional R&D expenses for the three-month period ended September 30, 2008, compared to the same period in 2007 are mainly related to the advancement of the Phase 3 program in BPH with the compound, cetrorelix.
Consolidated selling, general and administrative (SG&A) expenses were $3.3 million for the three-month period ended September 30, 2008 compared to $5.8 million for the same period in 2007. The decrease in SG&A expenses for the three-month period ended September 30, 2008 compared to the same period in 2007 is primarily related to organizational changes and cost saving measures that were implemented in the second quarter of 2008.
Consolidated net loss for the three-month period ended September 30, 2008 was $13.9 million or $0.26 per basic and diluted share compared to $8.7 million or $0.16 per basic and diluted share for the same period in 2007. The increase in net loss for the three-month period ended September 30, 2008 compared to the same period last year, is mainly related to the advancement of the cetrorelix Phase 3 program for BPH, lower manufacturing margins and foreign exchange loss.
The cash and short-term investments were $11 million as at September 30, 2008.
CONFERENCE CALL
Management will be hosting a conference call for the investment community beginning at 10:00 a.m. Eastern Time, today, November 13, 2008, to discuss third quarter 2008 financial results. To participate in the live conference call by telephone, please dial 416-646-3095, 514-807-8791 or 800-814-4859. Individuals interested in listening to the conference call on the Internet may do so by visiting www.aezsinc.com. A replay will be available on the Company's Web site for 30 days.
About AEterna Zentaris Inc.
AEterna Zentaris Inc. is a global biopharmaceutical company focused on endocrine therapy and oncology with proven expertise in drug discovery, development and commercialization.
News releases and additional information are available at www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned not to rely on these forward-looking statements. The Company does not undertake to update these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments except if we are requested by a governmental authority or applicable law.
Attachment: Financial summary
(In thousands of US dollars, except share
and per share data)
Three months ended Nine months ended
Sept. 30, Sept. 30,
(Unaudited) 2008 2007 2008 2007
-------------------------------------------------------------------------
-------------------------------------------------------------------------
$ $ $ $
Revenues
Sales and royalties 8,630 7,372 24,822 22,392
License fees 2,399 3,671 6,412 9,436
-------------------------------------------------------------------------
11,029 11,043 31,234 31,828
-------------------------------------------------------------------------
Operating expenses
Cost of sales 4,986 3,290 14,348 9,675
Research and development
costs, net of tax
credits and grants* 13,880 9,835 44,914 25,557
Selling, general and
administrative* 3,277 5,847 14,287 15,257
Depreciation and
amortization:
Property, plant and
equipment 433 426 1,199 1,183
Intangible assets 839 1,024 2,555 3,014
-------------------------------------------------------------------------
23,415 20,422 77,303 54,686
-------------------------------------------------------------------------
Loss from operations (12,386) (9,379) (46,069) (22,858)
Other income (expenses)
Interest income 149 494 737 1,369
Interest expense - (15) (68) (68)
Foreign exchange (loss)
gain (1,324) (170) 429 (766)
Loss on disposal of
long-lived assets held
for sale (90) - (125) -
-------------------------------------------------------------------------
(1,265) 309 973 535
-------------------------------------------------------------------------
Loss before income taxes (13,651) (9,070) (45,096) (22,323)
Income tax (expense)
recovery (228) 1,012 (228) 4,287
-------------------------------------------------------------------------
Net loss from continuing
operations (13,879) (8,058) (45,324) (18,036)
Net loss from
discontinued operations - (646) - (624)
-------------------------------------------------------------------------
Net loss for the period (13,879) (8,704) (45,324) (18,660)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Net loss per share from
continuing operations
Basic and diluted (0.26) (0.15) (0.85) (0.34)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Net loss per share
Basic and diluted (0.26) (0.16) (0.85) (0.35)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Weighted average number
of shares
Basic and diluted 53,187,470 53,184,803 53,187,470 53,181,248
-------------------------------------------------------------------------
-------------------------------------------------------------------------
* Stock-based
compensation costs
included in:
Research and
development 50 64 166 180
Selling, general
and administra-
tive 52 447 78 1,312
-------------------------------------------------------------------------
102 511 244 1,492
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Consolidated Statement of Comprehensive Income
Three months ended Nine months ended
Sept. 30, Sept. 30,
(Unaudited) 2008 2007 2008 2007
-------------------------------------------------------------------------
-------------------------------------------------------------------------
$ $ $ $
Net loss for the period (13,879) (8,704) (45,324) (18,660)
Other comprehensive
income (loss):
Foreign currency
translation (3,169) 6,315 (2,650) 13,204
Variation in the fair
value of short-term
investments (15) 81 (3) (87)
-------------------------------------------------------------------------
Comprehensive loss (17,063) (2,308) (47,977) (5,543)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
(In thousands of US dollars)
CONSOLIDATED BALANCE SHEETS September 30, December 31,
Unaudited 2008 2007
-------------------------------------------------------------------------
-------------------------------------------------------------------------
$ $
Cash and short-term investments 10,957 41,387
Other current assets 15,374 18,193
----------------------------
26,331 59,580
Long-term assets 46,227 63,783
----------------------------
Total assets 72,558 123,363
----------------------------
----------------------------
Current liabilities 17,611 22,255
Deferred revenues 4,508 3,333
Long-term payable 197 -
Employee future benefits 9,384 9,184
----------------------------
31,700 34,772
Shareholders' equity 40,858 88,591
----------------------------
Total liabilities and shareholders' equity 72,558 123,363
----------------------------
----------------------------
SOURCE AETERNA ZENTARIS INC.
Tags: appointment business cancer ceo clinical community conference equity executive financial results financial summary foreign exchange grants healthcare hosting japan law manufacturing market nasdaq partnership pharmaceuticals plant president property research and development sales securities tax taxes track trial web women
Companies: AEterna Zentaris Inc (AEZ), AEterna Zentaris Inc (AEZS)
AEterna Zentaris to sell Cetrotide royalty stream to CHRP - Zibb.com
Nov 13, 2008 (Datamonitor via COMTEX) --
AEterna Zentaris, a biopharmaceutical company, has signed a definitive agreement to sell to Cowen Healthcare Royalty Partners, its rights to royalties on future sales of Cetrotide covered by its license agreement with Merck Serono.
On closing, AEterna Zentaris will receive $52.5 million from Cowen Healthcare Royalty Partners (CHRP). In addition, contingent on 2010 net sales of Cetrotide reaching a specified level, AEterna Zentaris would receive an additional payment of $2.5 million from CHRP.
Under the terms of the agreement, if cetrorelix, which is currently in Phase III clinical trials for the treatment of benign prostatic hyperplasia, is approved for sale by European regulatory authorities in an indication other than in vitro fertilization, AEterna Zentaris has agreed to make a one-time cash payment to CHRP in an amount ranging from $5 million up to a maximum of $15 million. The amount which would be due to CHRP will be higher the earlier the product receives European regulatory approval.
RBC Capital Markets acted as exclusive financial advisor to AEterna Zentaris in connection with this transaction. The transaction is expected to close within the next 15 business days.
The licensing agreement between AEterna Zentaris and Merck Serono was signed in 2000 and granted Merck Serono exclusive rights to market, distribute and sell Cetrotide worldwide, with the exception of Japan, in the field of in vitro fertilization.
Juergen Engel, president and CEO of AEterna Zentaris, said: "We are very pleased with this transaction which is in line with our strategy of generating non-dilutive financing through non-core asset monetization. We now expect to end the year 2008 with approximately $50 million in cash, providing us with the financial resources for the continued development of cetrorelix in benign prostatic hyperplasia."
http://www.datamonitor.com
Republication or redistribution, including by framing or similar means, is expressly prohibited without prior written consent. Datamonitor shall not be liable for errors or delays in the content, or for any actions taken in reliance thereon
Tags: business ceo clinical healthcare japan market president sales
Companies: AEterna Zentaris Inc (AEZS), Merck & Co., Inc. (MRK)
AEterna enters second stage of patient recruitment for Phase II cancer trial - Zibb.com
Nov 04, 2008 (Datamonitor via COMTEX) --
AEterna Zentaris, a biopharmaceutical company, has entered the second stage of patient recruitment for its Phase II trial in endometrial cancer with AEZS-108, a luteinizing hormone-releasing hormone agonist linked to doxorubicin.
The decision to enter the second stage of patient recruitment was taken following recent first stage data reporting one complete response and two partial responses among 14 patients with a diagnosis of disseminated endometrial cancer. The trial is part of a Phase II program in gynecological cancers for which patient enrollment began in December 2007.
The open-label, non-comparative multi-center Phase II program will treat up to 82 women with luteinizing hormone-releasing hormone (LHRH)-receptor positive ovarian and endometrial cancerous tumors. The primary endpoint for the program is the partial or complete tumor response rate according to response evaluation criteria in solid tumors (RECIST) or Gynaecologic Cancer Intergroup guidelines.
Paul Blake, chief medical officer of AEterna Zentaris, said: "We are very pleased with this additional data on the early signal of potential efficacy of our lead oncology compound, AEZS-108 in both endometrial and ovarian cancer.
"The data also strengthens our belief that increased clinical benefit for patients could be achieved by specifically targeting LHRH-receptor expressing tumors using doxorubicin. Finally, this program remains on track and we expect to disclose full results over the next few months."
http://www.datamonitor.com
Republication or redistribution, including by framing or similar means, is expressly prohibited without prior written consent. Datamonitor shall not be liable for errors or delays in the content, or for any actions taken in reliance thereon
Tags: cancer clinical track trial women
Companies: AEterna Zentaris Inc (AEZS)
AEterna Zentaris Agrees to Sell Cetrotide(R) Royalty Stream for $52.5 Million to Cowen Healthcare
QUEBEC CITY, Nov 12, 2008 /PRNewswire-FirstCall via COMTEX/ --
All amounts are in U.S. dollars
AEterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ), a global biopharmaceutical company focused on endocrine therapy and oncology, today announced that it has signed a definitive agreement to sell to Cowen Healthcare Royalty Partners, L.P. ("CHRP") its rights to royalties on future sales of Cetrotide(R) covered by its license agreement with Merck Serono. The license agreement between AEterna Zentaris and Merck Serono was signed in 2000 and granted Merck Serono exclusive rights to market, distribute and sell Cetrotide(R) worldwide, with the exception of Japan, in the field of in vitro fertilization. On closing, AEterna Zentaris will receive $52.5 million from CHRP. In addition, contingent on 2010 net sales of Cetrotide(R) reaching a specified level, AEterna Zentaris would receive an additional payment of $2.5 million from CHRP.
Under the terms of the agreement, if cetrorelix, which is currently in Phase 3 clinical trials for the treatment of benign prostatic hyperplasia, is approved for sale by European regulatory authorities in an indication other than in vitro fertilization, AEterna Zentaris has agreed to make a one-time cash payment to CHRP in an amount ranging from $5 million up to a maximum of $15 million. The amount which would be due to CHRP will be higher the earlier the product receives European regulatory approval.
"We are very pleased with this transaction which is in line with our strategy of generating non-dilutive financing through non-core asset monetization," said Juergen Engel, Ph.D., President and Chief Executive Officer of AEterna Zentaris. "We now expect to end the year 2008 with approximately $50 million in cash, providing us with the financial resources for the continued development of cetrorelix in BPH."
"Our investment in Cetrotide(R) is consistent with our strategy to invest in unique commercial-stage products with strong marketing partners, and attractive risk reward profiles," said Todd C. Davis, Co-Founder and Managing Director of CHRP. "There is a growing demand for fertility treatment products around the globe and we believe Cetrotide(R) is well positioned to expand its presence in the market."
The transaction is expected to close within the next 15 business days.
RBC Capital Markets acted as exclusive financial advisor to AEterna Zentaris in connection with this transaction.
About Cetrotide(R) (cetrorelix)
Cetrotide(R) (cetrorelix) was the first luteinizing hormone-releasing hormone (LHRH) antagonist treatment approved for in vitro fertilization. It is administered to women to prevent premature ovulation in order to increase fertility success rate. Developed in cooperation with Medicine Nobel-Prize winner, Professor Andrew Schally of Veterans Affairs, Miami, Florida, it was launched in Europe in 1999 and in the United States in 2001. Cetrotide(R) is currently marketed worldwide by Merck Serono, except for Japan where it is marketed by Nippon Kayaku and Shionogi.
Cetrorelix is also currently in a Phase 3 program in benign prostatic hyperplasia involving 1,500 patients in North America and Europe. First results are expected in Q3 2009 with an NDA filing to follow in 2010 and potential launch in 2011.
About Cowen Healthcare Royalty Partners
Cowen Healthcare Royalty Partners ("CHRP") is a global healthcare private equity firm with over $500 million in capital under management. The firm invests principally in commercial-stage biopharmaceutical and medical device companies and products, through the purchase of royalty or Synthetic Royalty(SM) interests, debt and equity. CHRP's investment team has over 90 years of healthcare related experience including principal investing, structured finance, healthcare industry senior management, Wall Street research and consulting, scientific and clinical experience. For more information, please visit www.cowenroyalty.com.
About AEterna Zentaris Inc.
AEterna Zentaris Inc. is a global biopharmaceutical company focused on endocrine therapy and oncology, with proven expertise in drug discovery, development and commercialization.
News releases and additional information are available at www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned not to rely on these forward-looking statements. The Company does not undertake to update these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments except if we are requested by a governmental authority or applicable law.
SOURCE AETERNA ZENTARIS INC.
Tags: business ceo clinical commercial consulting debt equity europe finance healthcare investment japan law market marketing medical medicine nasdaq north america president Private Equity products sales science securities veterans women
Companies: AEterna Zentaris Inc (AEZ), AEterna Zentaris Inc (AEZS), Merck & Co., Inc. (MRK)
News from Zibb.com
- AEterna Zentaris Reports Third Quarter 2008 Financial and Operating Results - Zibb.com
- AEterna Zentaris to sell Cetrotide royalty stream to CHRP - Zibb.com
- AEterna enters second stage of patient recruitment for Phase II cancer trial - Zibb.com
- AEterna Zentaris Agrees to Sell Cetrotide(R) Royalty Stream for $52.5 Million to Cowen Healthcare
