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Third Quarter 2008 Management s Discussion and Analysis of Financial Condition and Results of Operations The following analysis provides a review of the Company s results of operations, financial condition and cash flows

Key Takeaway: Management s Discussion and of Financial Condition and Results of Operations The following analysis provides a review of the Company s results of operations, financial condition and cash flows for the three-month and nine-month periods ended September 30, 2008 and 2007. In t

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Management s Discussion and
of Financial Condition and
Results of Operations
The following analysis provides a review of
the Company s results of operations, financial condition and cash flows for the
three-month and nine-month periods ended September 30, 2008 and 2007. In this Management s
Discussion and Analysis (MD&A), the Company , we , us , and our mean
terna Zentaris Inc. and its subsidiaries. This discussion should be read in conjunction
with the information contained in terna Zentaris Inc. s interim consolidated
financial statements and related notes for the three-month and nine-month
periods ended on September 30, 2008 and 2007. Our consolidated financial
statements are reported in United States dollars and have been prepared in
accordance with Generally Accepted Accounting Principles in Canada, or Canadian
Generally Accepted Accounting Principles (Canadian GAAP). All amounts are in US dollars unless otherwise indicated.

Company Overview

Inc. (TSX: AEZ, NASDAQ: AEZS) is a global biopharmaceutical company focused on
endocrine therapy and oncology.
pipeline encompasses compounds at all stages of development, from drug
discovery through marketed products. The two highest priority clinical programs
are our lead value driver, cetrorelix for benign prostatic hyperplasia (BPH)
and our lead oncology program, AEZS-108 for advanced endometrial and advanced

Key Developments for the Quarter Ended September 30, 2008

2008, Juergen Engel, Ph.D., was appointed President and CEO of the Company, 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,
We completed patient recruitment for
the second efficacy trial of our Phase 3 program in BPH with our lead compound,
We entered the second stage of
recruitment for our 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
license and cooperation agreement for the commercialization of cetrorelix in
BPH, with Handok Pharmaceuticals Co., Ltd. (Handok) for the Korean market.
Furthermore, subsequent to quarter-end, we signed another agreement with Handok for the
commercialization of ozarelix in BPH also for the Korean market.
We regained worldwide rights from
Ardana plc (LSE: ARA) for the Growth Hormone Secretagogue (GHS) compound,
AEZS-130. In 2002, we had granted Ardana an exclusive worldwide license to
develop and market AEZS-130. A Phase 1 clinical trial has been completed with
AEZS-130 for therapeutic use in growth hormone deficiencies. Future development
options are currently being evaluated for the use of this compound.

Subsequent to Quarter-End

On November 11, 2008, we agreed to sell to
Cowen Healthcare Royalty Partners, L.P. ( CHRP ), our rights to royalties on
future sales of Cetrotide covered
by our license agreement with Merck Serono. The license agreement between terna
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, terna
Zentaris will receive $52.5 million from CHRP. In addition, contingent on
2010 net sales of Cetrotide reaching a specified level, we 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, terna 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
The transaction is expected to close on or before December 2,
Status of our drug pipeline
as of November 12, 2008
Discovery Preclinical Phase 1 Phase 2 Phase 3 Commercial
120,000 compound library AEZS-115 (endometriosis & urology) AEZS-120 (oncology vaccine) Erk & PI3K Inhibitors (oncology) Ghrelin receptor ligands (endocrinology) AEZS-127 (oncology) AEZS-112 (oncology) AEZS-130 (endocrinology) AEZS-108 (endometrial and ovarian cancers) Cetrorelix (endometriosis) (BPH in Japan) Ozarelix (BPH, prostate cancer) Perifosine (multiple cancers) Cetrorelix (BPH) Cetrotide ( in vitro fertilization)
Partners
Cetrorelix: Shionogi in Japan Ozarelix : Spectrum in North America and India, Nippon Kayaku in Japan Ozarelix (BPH): Handok in Korea Perifosine: Keryx in North America Cetrorelix (BPH): Handok in Korea Cetrotide : Merck Serono (World ex-Japan) Nippon Kayaku / Shionogi (Japan)
In September 2008, we
reported the completion of patient recruitment for the second efficacy trial of
this program, which involves approximately 400 patients primarily in Europe.
In April 2008, we reported
the completion of patient recruitment for the first efficacy trial of this same
program. The study involves approximately 600 patients primarily in the United
States and Canada, with additional sites in Europe.
In May 2008, we had also
reported first patient dosing for the safety trial, an open-label,
single-armed, multi-center study involving approximately 500 patients in North
First efficacy results of this
Phase 3 program are expected in the third quarter of 2009.
In July 2008, we signed a
license and cooperation agreement for the commercialization of cetrorelix in
BPH with Handok Pharmaceuticals Co., Ltd. (Korea Stock Exchange: Koscom) for
the Korean market, providing us with upfront and future milestone payments
based on approval, launch and future sales of cetrorelix in this indication.
In September 2008, we announced
that we had entered the second stage of patient recruitment for our Phase 2
trial in ovarian cancer with AEZS-108, a luteinizing hormone-releasing hormone
(LHRH) agonist linked to doxorubicin. The trial is part of a Phase 2
program in gynaecological cancers which will include up to 82 women (up to 41
with ovarian cancer and up to 41 with endometrial cancer).
Subsequent to quarter-end, we
signed a license and cooperation agreement for the commercialization of
ozarelix in BPH with Handok for the Korean market, providing us with upfront
and future milestone payments based on approval, launch and future sales of
Consolidated Results of Operations
For the three-month and nine-month periods ended September 30,
2007, consolidated revenues and expenses of Echelon Biosciences have been
reclassified as discontinued operations. Since we disposed of our entire
position in Echelon Biosciences in November 2007, going forward we will no
longer have access to liquidity or cash flows from said company.
The following table sets forth selected Canadian GAAP consolidated
financial data in thousands of US dollars, except shares and per share data.
Three months ended Sept. 30, Nine months ended 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 administrative 52 447 78 1,312
102 511 244 1,492
Last updated: Nov 13, 2008