Transition Therapeutics Announces Fiscal 2013 Year End Financial Results
TORONTO, Sept. 11, 2013 /PRNewswire/ – 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 year ended June 30, 2013.
During fiscal 2013 and up to the date of this press release, the Company
announced the following:
-- September 4, 2013 - Transition announced that their licensing partner Elan had dosed the first patient in a Phase 2a clinical study of ELND005 in Down Syndrome;
-- July 17, 2013 - Transition announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation to the development program for ELND005 which was submitted for the treatment of Neuropsychiatric Symptoms (NPS) in Alzheimer's disease (AD).The FDA concluded that the development program for ELND005 for the treatment of NPS in AD meets their criteria for Fast Track Designation. Transition's licensing partner, Elan is responsible for all development and commercialization activities and costs of ELND005;
-- November 28, 2012 - Transition announced that their licensing partner Elan had enrolled the first patient in a Phase 2 study of ELND005 for the treatment of agitation/aggression in patients with moderate to severe Alzheimer's disease;
-- August 30, 2012 - Transition announced that their licensing partner Elan had dosed the first patient in a Phase 2 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.
-- June 17, 2013 - Transition announced that Lilly has exercised its option to assume all development and commercialization rights to type 2 diabetes drug candidate TT-401. In conjunction with this assumption of rights, Transition received a US$7 million milestone payment;
-- April 30, 2013 - Transition announced the results of a five-week proof of concept clinical study of TT-401 in type 2 diabetic and obese non-diabetic subjects. In the study, TT-401, a once-weekly administered peptide, demonstrated significant improvements in glycemic control and reductions in body weight.
-- July 23, 2013 - Transition announced the exclusive licensing of worldwide rights to a novel small molecule transcriptional regulator ("TT-601") from Lilly for the treatment of osteoarthritis ("OA") pain.TT-601 is a potent and selective ligand for a novel nuclear receptor target. Modulating the activity of this novel target in patients with osteoarthritis may provide pain relief to a large segment of OA patients who do not have adequate response to therapy with NSAIDs (non-steroidal anti-inflammatory drugs). TT-601 has completed preclinical development to date and Transition anticipates can enter the clinic in the first half of calendar 2014.
-- August 15, 2013 - Transition announced the closing of the private placement involving Jack W. Schuler, Larry N. Feinberg, Oracle Investment Management, certain Transition Board members, management and other existing shareholders of US$11 million by purchasing 2,625,300 units of the Company at a price of US$4.19 per common share.
The Company’s cash and cash equivalents and short term investments were
$28,125,639 at June 30, 2013.
Subsequent to June 30, 2013, the Company announced the issuance of
2,625,300 units in a private placement to existing shareholders, board
members and management which resulted in gross proceeds of $US11
million. Each unit consisted of (i) one common share, (ii) 0.325 Common
Share purchase warrant with a purchase price of US$4.60 per whole
warrant and (iii) 0.4 Common Share purchase warrant with a purchase
price of US$6.50 per whole warrant. Each whole warrant will entitle the
holder, within two years, to purchase one additional common share in
the capital of the Company. If and when all of the warrants are
exercised, the Company will realize an additional US$10.7 million in
In light of the recent private placement, 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.
During the year ended June 30, 2013, the Company recorded a net income
of $23,297 ($0.00 income per common share) compared to a net loss of
$12,269,845 ($0.48 loss per common share) for the year ended June 30,
In fiscal 2013, the Company recognized $17,933,500 as revenue which
represents the milestone payment of $10,815,200 (US$11,000,000)
received from Elan upon their commencement of the next ELND005 clinical
trial and the milestone payment of $7,118,300 (US$7,000,000) received
from Lilly upon exercising its option to assume all development and
commercialization rights to type 2 diabetes drug candidate TT-401.
Revenue is $17,933,500 in the year ended June 30, 2013 compared to nil
in the year ended June 30, 2012.
Research and development expenses increased $664,147 or 8% from
$8,198,725 for the fiscal year ended June 30, 2012 to $8,862,872 for
the fiscal year ended June 30, 2013. The increase in research and
development expenses is primarily due to an increase in clinical
development costs related to TT-401/TT-402 which has been partially
offset by a decrease in clinical development costs related to
General and administrative expenses decreased by $849,488 or 19% from
$4,407,280 for the fiscal year ended June 30, 2012 to $3,557,792 for
the fiscal year ended June 30, 2013. The decreases in general and
administrative expenses during the fiscal year ended June 30, 2013 are
due to decreases in legal consulting fees 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. The decrease in general and administrative
expenses has been partially offset by increased investor relation
Impairment of intangible assets is $6,545,821 for the year ended June
30, 2013 compared to nil for the year ended June 30, 2012. During the
year ended June 30, 2013, the Company decided to no longer develop
TT-301 and TT-302, the compounds acquired from NMX. Accordingly, the
Company has recognized an impairment loss of $6,545,821.
Transition is a biopharmaceutical company, developing novel therapeutics
for disease indications with large markets. The Company’s lead CNS drug
candidate is ELND005 for the treatment of Alzheimer’s disease and
bipolar disorder. Transition’s lead metabolic drug candidate is TT-401
for the treatment of type 2 diabetes and accompanying obesity. The
Company’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
In Canadian Dollars June 30, 2013 June 30, 2012 Assets Current assets Cash and cash equivalents 23,067,937 12,955,081 Short term investments 5,057,702 6,057,264 Other receivables 35,792 43,658 Investment tax credits receivable 180,652 241,951 Prepaid expenses and deposits 359,164 316,286 28,701,247 19,614,240 Non-current assets Property and equipment 168,034 215,000 Intangible assets 8,938,674 17,263,790 Total assets 37,807,955 37,093,030 Liabilities Current liabilities Trade and other payables 874,149 1,178,915 Current portion of contingent 2,321,373 2,321,373 consideration payable 3,195,522 3,500,288 Non-current liabilities Contingent consideration payable 1,434,958 1,434,958 Leasehold inducement 22,863 34,295 4,653,343 4,969,541 Equity attributable to owners of the Company Share capital 165,367,524 165,334,259 Contributed surplus 14,768,002 13,168,411 Share-based payment reserve 2,352,002 2,977,032 Deficit (149,332,916) (149,356,213) 33,154,612 32,123,489 Total liabilities and equity 37,807,955 37,093,030
CONSOLIDATED STATEMENTS OF INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS)
For the year ended June 30, 2013 and 2012
In Canadian Dollars 2013 2012 Revenues Licensing fees 17,933,500 - Expenses Research and development 8,862,872 8,198,725 Selling, general and administrative expenses 3,557,792 4,407,280 Impairment of intangible assets 6,545,821 - Loss on disposal of property and equipment - 125,748 18,966,485 12,731,753 Operating loss (1,032,985) (12,731,753) Interest income 146,209 165,070 Interest expense - (851) Foreign exchange gain 910,073 297,689 Net income (loss) and comprehensive income 23,297 (12,269,845) ( loss) for the year Basic and diluted net income (loss) per 0.00 (0.48) common share
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.