TORONTO, Feb. 7, 2013 /CNW/ - Transition Therapeutics Inc. ("Transition" or the "Company") (TSX: TTH; NASDAQ: TTHI), a
product-focused biopharmaceutical company developing therapeutics for
disease indications with large markets, today announced its financial
results for the three and six month periods ended December 31, 2012.
Selected Highlights
During fiscal 2013 and up to the date of this press release, the Company
announced the following:
- On November 28, 2012, Transition announced that their licensing partner
Elan had enrolled the first patient in a Phase II study of ELND005 for
the treatment of agitation/aggression in patients with moderate to
severe Alzheimer's disease;
- On August 30, 2012, Transition announced that their licensing partner
Elan had dosed the first patient in a Phase II clinical study of
ELND005 in Bipolar Disorder. The study is a placebo-controlled, safety and efficacy study of oral
ELND005 as an adjunctive maintenance treatment in patients with Bipolar
1 Disorder to delay the time to occurrence of mood episodes. As the
first patient has been dosed in the study, Transition received a
milestone payment of US$11 million from Elan.
Financial Liquidity
The Company's cash and cash equivalents and short term investments were
$24,958,522 at December 31, 2012.
The Company's current cash projection indicates that the current cash
resources should enable the Company to execute its core business plan
and meet its projected cash requirements well beyond the next 12
months.
Financial Review
For the three month period ended December 31, 2012, the Company recorded
a net loss of $2,754,534 ($0.10 loss per common share) compared to net
loss of $3,790,421 ($0.15 loss per common share) for the three month
period ended December 31, 2011.
For the six month period ended December 31, 2012, the Company recorded a
net income of $4,981,512 ($0.19 income per common share) compared to a
net loss of $6,661,178 ($0.28 loss per common share) for the six-month
period ended December 31, 2011.
Revenue is nil and $10,815,200 in the three and six month periods ended
December 31, 2012 respectively, compared to nil in both three and six
month period ended December 31, 2011.
In August 2012, Elan dosed the first patient in a Phase 2 clinical study
of ELND005 in Bipolar Disorder. In light of the amendments to the Elan
agreement, the Company has recognized $10,815,200 (US$11,000,000) as
revenue during the first quarter of fiscal 2013 which represents the
milestone payment received from Elan upon their commencement of the
next ELND005 clinical trial. The payment from Elan was received on
October 1, 2012.
Research and development expenses increased $80,635 or 4% from
$2,060,622 for the three month period ended December 31, 2011 to
$2,141,257 for the three month period ended December 31, 2012. The
increase is largely due to an increase in clinical development costs
related to TT-401/402, which has been offset by decreases in clinical
development costs related to TT-301/302 and salaries and related costs
associated with headcount reductions.
For the six month period ended December 31, 2012, research and
development expenses decreased $118,543 or 3% to $4,195,803 from
$4,314,346 for the same period in fiscal 2012. The decrease is
primarily due to decreases in clinical development costs related to
TT-301/302 and salaries and related costs associated with headcount
reductions. The decrease is largely offset by increased clinical
development costs related to TT-401/402.
General and administrative expenses decreased by $683,472 or 45% from
$1,532,912 for the three month period ended December 31, 2011 to
$849,440 for the three month period ended December 31, 2012. For the
six month period ended December 31, 2012, general and administrative
expenses decreased $956,616 or 36% to $1,666,342 from $2,622,958 for
the same period in fiscal 2012.
The decreases in general and administrative expenses for both the three
and six month periods ended December 31, 2012 are due to decreases in
legal consulting fees, facility lease costs, and investor relation and
business development expenses, as well as decreased salaries and
related costs resulting from headcount reductions as the comparative
periods included severances relating to terminations.
About Transition
Transition is a biopharmaceutical company, developing novel therapeutics
for disease indications with large markets. Transition's lead product
is ELND005 for the treatment of Alzheimer's disease and bipolar
disorder. Transition also has an emerging pipeline of innovative
preclinical and clinical drug candidates. The other drugs in the
pipeline that the Company is developing are for anti-inflammatory and
metabolic indications. Transition's shares are listed on the NASDAQ
under the symbol "TTHI" and the Toronto Stock Exchange under the symbol
"TTH". For additional information about the Company, please visit www.transitiontherapeutics.com.
Extracts of the Financial Statements to Follow:
CONSOLIDATED BALANCE SHEETS
(Unaudited)
As at
In Canadian Dollars | December 31, 2012 |
| June 30, 2012 |
|
|
|
|
|
|
Assets |
|
|
|
|
Current assets |
|
|
|
|
Cash and cash equivalents
| 18,955,854 |
|
12,955,081
|
|
Short term investments
| 6,002,668 |
|
6,057,264
|
|
Trade and other receivables
| 48,408 |
|
43,658
|
|
Investment tax credits receivable
| 370,289 |
|
241,951
|
|
Prepaid expenses and deposits
| 458,037 |
|
316,286
|
|
|
|
|
|
|
| 25,835,256 |
|
19,614,240
|
|
Non-current assets |
|
|
|
|
Property and equipment
| 194,181 |
|
215,000
|
|
Intangible assets
| 16,374,143 |
|
17,263,790
|
|
Total assets | 42,403,580 |
|
37,093,030
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
Current liabilities |
|
|
|
|
Trade and other payables
| 896,145 |
|
1,178,915
|
|
Current portion of contingent consideration payable
| 2,321,373 |
|
2,321,373
|
|
| 3,217,518 |
|
3,500,288
|
|
|
|
|
|
|
Non-current liabilities |
|
|
|
|
Contingent consideration payable
| 1,434,958 |
|
1,434,958
|
|
Leasehold inducement
| 28,579 |
|
34,295
|
|
| 4,681,055 |
|
4,969,541
|
|
|
|
|
|
|
Equity attributable to owners of the Company |
|
|
|
|
Share capital
| 165,334,259 |
|
165,334,259
|
|
Contributed surplus
| 13,431,445 |
|
13,168,411
|
|
Share-based payment reserve
| 3,331,522 |
|
2,977,032
|
|
Deficit
| (144,374,701) |
|
(149,356,213)
|
|
| 37,722,525 |
|
32,123,489
|
|
|
|
|
|
|
Total liabilities and equity | 42,403,580 |
|
37,093,030
|
|
CONSOLIDATED STATEMENTS OF INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS)
For the six and three month periods ended December 31, 2012 and 2011
(Unaudited)
In Canadian Dollars |
| Six month period ended December 31, 2012 |
|
Six month
period ended
December 31,
2011
|
| Three month period ended December 31, 2012 |
|
Three month
period ended
December 31,
2011
|
|
|
|
|
|
|
|
|
|
Revenues |
|
|
|
|
|
|
|
|
Licensing fees
|
| 10,815,200 |
| - |
| - |
| - |
Expenses |
|
|
|
|
|
|
|
|
Research and development
|
| 4,195,803 |
|
4,314,346
|
| 2,141,257 |
|
2,060,622
|
Selling, general and administrative expenses
|
| 1,666,342 |
|
2,622,958
|
| 849,440 |
|
1,532,912
|
Loss on disposal of property and equipment
|
| - |
|
118,623
|
| - |
|
38,709
|
|
|
|
|
|
|
|
|
|
Operating income (loss) |
| 4,953,055 |
|
(7,055,927)
|
| (2,990,697) |
|
(3,632,243)
|
|
|
|
|
|
|
|
|
|
Interest income
|
| 68,489 |
|
80,339
|
| 34,872 |
|
40,412
|
Interest expense
|
| - |
|
(851)
|
| - |
|
(241)
|
Foreign exchange gain (loss)
|
| (40,032) |
|
315,261
|
| 201,291 |
|
(198,349)
|
Net income (loss) and comprehensive income (loss) for the period |
| 4,981,512 |
|
(6,661,178)
|
| (2,754,534) |
|
(3,790,421)
|
Basic and diluted net income (loss) per common share |
| 0.19 |
|
(0.28)
|
| (0.10) |
|
(0.15)
|
Notice to Readers: Information contained in our press releases should be
considered accurate only as of the date of the release and may be
superseded by more recent information we have disclosed in later press
releases, filings with the OSC, SEC or otherwise. Except for historical
information, this press release may contain forward-looking statements,
relating to expectations, plans or prospects for Transition, including
conducting clinical trials. These statements are based upon the current
expectations and beliefs of Transition's management and are subject to
certain risks and uncertainties that could cause actual results to
differ materially from those described in the forward-looking
statements. These risks and uncertainties include factors beyond
Transition's control and the risk factors and other cautionary
statements discussed in Transition's quarterly and annual filings with
the Canadian commissions.
SOURCE: Transition Therapeutics Inc.
<p> For further information on Transition, visit <a href="http://www.transitiontherapeutics.com">www.transitiontherapeutics.com</a>, or contact: </p> <p> Dr. Tony Cruz<br/> Chairman & Chief Executive Officer<br/> Transition Therapeutics Inc.<br/> Phone: (416) 260-7770, x.223<br/> <a href="mailto:tcruz@transitiontherapeutics.com">tcruz@transitiontherapeutics.com </a> </p> <p> Nicole Rusaw-George<br/> Chief Financial Officer<br/> Transition Therapeutics Inc.<br/> Phone: (416) 260-7770, x.202<br/> <a href="mailto:nrusaw@transitiontherapeutics.com">nrusaw@transitiontherapeutics.com</a> </p>