Exhibit 99.3
Consolidated Financial Statements
(Unaudited)
Transition Therapeutics Inc.
For the three and six months ended December 31, 2015 and 2014
Transition Therapeutics Inc.
CONSOLIDATED BALANCE SHEETS
(Unaudited)
In Canadian Dollars | | Note | | | As At December 31, 2015 | | | As at June 30, 2015 | |
| | | | | | | | | | | | |
Assets | | | | | | | | | | | | |
Current assets | | | | | | | | | | | | |
Cash | | | | | | | 29,070,189 | | | | 40,510,758 | |
Other receivables | | | | | | | 72,553 | | | | 265,189 | |
Income tax and investment tax credits receivable | | | | | | | 399,668 | | | | 399,668 | |
Prepaid expenses and deposits | | | | | | | 328,921 | | | | 259,143 | |
| | | | | | | 29,871,331 | | | | 41,434,758 | |
Non-current assets | | | | | | | | | | | | |
Property and equipment | | | | | | | 152,530 | | | | 191,944 | |
Intangible assets | | | 5 | | | | 7,759,188 | | | | 8,022,383 | |
Total assets | | | | | | | 37,783,049 | | | | 49,649,085 | |
| | | | | | | | | | | | |
Liabilities | | | | | | | | | | | | |
Current liabilities | | | | | | | | | | | | |
Trade and other payables | | | 6 | | | | 2,064,780 | | | | 8,549,895 | |
Contingent consideration payable | | | 7 | | | | 935,848 | | | | 858,257 | |
| | | | | | | 3,000,628 | | | | 9,408,152 | |
Non-current liabilities | | | | | | | | | | | | |
Contingent consideration payable | | | 7 | | | | 3,980,476 | | | | 3,503,344 | |
Total liabilities | | | | | | | 6,981,104 | | | | 12,911,496 | |
| | | | | | | | | | | | |
Equity attributable to owners of the Company | | | | | | | | | | | | |
Share capital | | | 9 | | | | 233,623,544 | | | | 233,633,493 | |
Warrants | | | 9 | | | | 3,150,558 | | | | 5,176,397 | |
Contributed surplus | | | | | | | 17,170,146 | | | | 14,771,907 | |
Share-based payment reserve | | | 9 | | | | 6,472,380 | | | | 5,892,305 | |
Accumulated other comprehensive income | | | | | | | (662,748 | ) | | | (281,814 | ) |
Deficit | | | | | | | (228,951,935 | ) | | | (222,454,699 | ) |
Total equity | | | | | | | 30,801,945 | | | | 36,737,589 | |
| | | | | | | | | | | | |
Total liabilities and equity | | | | | | | 37,783,049 | | | | 49,649,085 | |
| | | | | | | | | | | | |
Contingencies and commitments | | | 12 | | | | | | | | | |
The notes are an integral part of these consolidated financial statements
On behalf of the Board:
| ![](https://capedge.com/proxy/6-K/0001144204-16-080033/tex99-3sig1.jpg) | ![](https://capedge.com/proxy/6-K/0001144204-16-080033/tex99-3sig2.jpg) |
| Tony Cruz | Christopher Henley |
| Director | Director |
Transition Therapeutics Inc.
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
For the six and three months ended December 31, 2015 and 2014
(Unaudited)
In Canadian Dollars, except per share data | | | Note | | | Six month period ended December 31, 2015 | | | Six month period ended December 31, 2014 | | | Three month period ended December 31, 2015 | | | Three month period ended December 31, 2014 | |
| | | | | | | | | | | | | | | | | | | | |
Expenses | | | | | | | | | | | | | | | | | | | | |
Research and development | | | 10 | | | | 6,388,426 | | | | 31,939,780 | | | | 1,662,946 | | | | 15,904,889 | |
Selling, general and administrative expenses | | | 10 | | | | 2,619,202 | | | | 2,509,281 | | | | 1,218,794 | | | | 1,203,449 | |
| | | | | | | | | | | | | | | | | | | | |
Operating Loss | | | | | | | (9,007,628 | ) | | | (34,449,061 | ) | | | (2,881,740 | ) | | | (17,108,338 | ) |
Change in fair value of contingent consideration payable | | | 7 | | | | (230,422 | ) | | | (470,959 | ) | | | (1,563 | ) | | | (245,658 | ) |
Interest income | | | | | | | 63,719 | | | | 112,247 | | | | 26,255 | | | | 46,554 | |
Foreign exchange gain | | | | | | | 2,677,095 | | | | 2,202,310 | | | | 851,268 | | | | 397,303 | |
Net loss for the period | | | | | | | (6,497,236 | ) | | | (32,605,463 | ) | | | (2,005,780 | ) | | | (16,910,139 | ) |
| | | | | | | | | | | | | | | | | | | | |
Other Comprehensive loss for the period | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | |
Items that may be subsequently reclassified to net income: | | | | | | | | | | | | | | | | | | | | |
Cumulative translation adjustment | | | | | | | (380,934 | ) | | | (39,676 | ) | | | (384,448 | ) | | | (57,099 | ) |
Comprehensive loss for the period | | | | | | | (6,878,170 | ) | | | (32,645,139 | ) | | | (2,390,228 | ) | | | (16,967,238 | ) |
Basic and diluted net loss per common share | | | 11 | | | | (0.17 | ) | | | (0.93 | ) | | | (0.05 | ) | | | (0.48 | ) |
The notes are an integral part of these consolidated financial statements.
Transition Therapeutics Inc.
CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY
For the six month periods ended December 31, 2015 and 2014
(Unaudited)
| | | | | | | | Attributable to equity holders of the Company | | | | | | | | | | |
In Canadian Dollars | | Note | | | Number of common shares | | | Share capital | | | Warrants | | | Contributed surplus | | | Share-based payment reserve | | | Accumulated Other Comprehensive Income | | | Deficit | | | Total equity | |
| | | | | # | | | $ | | | $ | | | $ | | | $ | | | $ | | | $ | | | $ | |
Balance, July 1, 2015 | | | | | | | 38,878,879 | | | | 233,633,493 | | | | 5,176,397 | | | | 14,771,907 | | | | 5,892,305 | | | | (281,814 | ) | | | (222,454,699 | ) | | | 36,737,589 | |
Net loss for the period | | | | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | (6,497,236 | ) | | | (6,497,236 | ) |
Cumulative translation adjustment | | | | | | | - | | | | - | | | | - | | | | - | | | | - | | | | (380,934 | ) | | | - | | | | (380,934 | ) |
Share issuance costs pursuant to public offering, net | | | 9 | | | | - | | | | (9,949 | ) | | | - | | | | - | | | | - | | | | - | | | | - | | | | (9,949 | ) |
Share options exercised, expired or cancelled | | | 9 | | | | - | | | | - | | | | - | | | | 372,400 | | | | (372,400 | ) | | | - | | | | - | | | | - | |
Warrants expired | | | 9 | | | | - | | | | - | | | | (2,025,839 | ) | | | 2,025,839 | | | | - | | | | - | | | | - | | | | - | |
Share-based payment compensation expense | | | 9 | | | | - | | | | - | | | | - | | | | - | | | | 952,475 | | | | - | | | | - | | | | 952,475 | |
Balance, December 31, 2015 | | | | | | | 38,878,879 | | | | 233,623,544 | | | | 3,150,558 | | | | 17,170,146 | | | | 6,472,380 | | | | (662,748 | ) | | | (228,951,935 | ) | | | 30,801,945 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Balance, July 1, 2014 | | | | | | | 35,303,913 | | | | 207,374,493 | | | | 5,176,397 | | | | 14,768,221 | | | | 2,866,292 | | | | 24,028 | | | | (171,115,171 | ) | | | 59,094,260 | |
Net loss for the period | | | | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | (32,605,463 | ) | | | (32,605,463 | ) |
Cumulative translation adjustment | | | | | | | - | | | | - | | | | - | | | | - | | | | - | | | | (39,676 | ) | | | - | | | | (39,676 | ) |
Share options exercised, expired or cancelled | | | 9 | | | | 12,170 | | | | 44,764 | | | | - | | | | - | | | | (18,535 | ) | | | - | | | | - | | | | 26,229 | |
Share-based payment compensation expense | | | 9 | | | | - | | | | - | | | | - | | | | - | | | | 1,565,220 | | | | - | | | | - | | | | 1,565,220 | |
Balance, December 31, 2014 | | | | | | | 35,316,083 | | | | 207,419,257 | | | | 5,176,397 | | | | 14,768,221 | | | | 4,412,977 | | | | (15,648 | ) | | | (203,720,634 | ) | | | 28,040,570 | |
The notes are an integral part of these consolidated financial statements.
Transition Therapeutics Inc.
CONSOLIDATED STATEMENTS OF CASH FLOWS
For the six and three month periods ended December 31, 2015 and 2014
(Unaudited)
In Canadian Dollars | | Note | | | Six month period ended December 31, 2015 | | | Six month period ended December 31, 2014 | | | Three month period ended December 31, 2015 | | | Three month period ended December 31, 2014 | |
| | | | | | | | | | | | | | | | | | | | |
Cash flows from operating activities | | | | | | | | | | | | | | | | | | | | |
Net loss for the period | | | | | | | (6,497,236 | ) | | | (32,605,463 | ) | | | (2,005,780 | ) | | | (16,910,139 | ) |
Adjustments for: | | | | | | | | | | | | | | | | | | | | |
Change in fair value of contingent consideration payable | | | | | | | 230,422 | | | | 470,959 | | | | 1,563 | | | | 245,658 | |
Depreciation and amortization | | | | | | | 372,547 | | | | 332,826 | | | | 186,447 | | | | 171,230 | |
Share-based payment compensation expense | | | | | | | 952,475 | | | | 1,565,220 | | | | 534,960 | | | | 673,566 | |
Accrued interest | | | | | | | - | | | | 34,562 | | | | - | | | | 34,562 | |
Unrealized foreign exchange gain | | | | | | | (3,033,883 | ) | | | (2,653,341 | ) | | | (999,294 | ) | | | (846,862 | ) |
Change in working capital | | | 13 | | | | (6,816,644 | ) | | | (3,650,791 | ) | | | (1,473,763 | ) | | | (3,418,617 | ) |
Net cash used in operating activities | | | | | | | (14,792,319 | ) | | | (36,506,028 | ) | | | (3,755,867 | ) | | | (20,050,602 | ) |
| | | | | | | | | | | | | | | | | | | | |
Cash flows from investing activities | | | | | | | | | | | | | | | | | | | | |
Maturity of short term investments | | | | | | | - | | | | 3,025,000 | | | | - | | | | 3,025,000 | |
Purchase of property and equipment | | | | | | | (687 | ) | | | (119,722 | ) | | | - | | | | (82,256 | ) |
Net cash (used in) provided by investing activities | | | | | | | (687 | ) | | | 2,905,278 | | | | - | | | | 2,942,744 | |
| | | | | | | | | | | | | | | | | | | | |
Cash flows from financing activities | | | | | | | | | | | | | | | | | | | | |
Share issuance costs paid | | | | | | | (9,949 | ) | | | - | | | | - | | | | - | |
Proceeds from share options exercised | | | 9 | | | | - | | | | 26,229 | | | | - | | | | 20,791 | |
Net cash provided by (used in) financing activities | | | | | | | (9,949 | ) | | | 26,229 | | | | - | | | | 20,791 | |
| | | | | | | | | | | | | | | | | | | | |
Foreign exchange gains on cash | | | | | | | 3,362,386 | | | | 3,118,841 | | | | 1,022,855 | | | | 1,061,351 | |
| | | | | | | | | | | | | | | | | | | | |
Net decrease in cash | | | | | | | (11,440,569 | ) | | | (30,455,680 | ) | | | (2,733,012 | ) | | | (16,025,716 | ) |
Cash at beginning of period | | | | | | | 40,510,758 | | | | 57,212,004 | | | | 31,803,201 | | | | 42,782,040 | |
Cash at end of period | | | | | | | 29,070,189 | | | | 26,756,324 | | | | 29,070,189 | | | | 26,756,324 | |
The notes are an integral part of these consolidated financial statements
Notes to the Audited Consolidated Financial Statements
December 31, 2015
(Unaudited in Canadian Dollars)
| 1. | GENERAL INFORMATION AND NATURE OF OPERATIONS |
Transition Therapeutics Inc. and its subsidiaries (together the Company or Transition) was incorporated by Articles of Incorporation under the Business Corporations Act (Ontario) on July 6, 1998. The Company is a public company with common shares listed on both the NASDAQ and Toronto Stock Exchange and is incorporated and domiciled in Canada. The address of its registered office is 101 College Street, Suite 220, Toronto, Ontario, Canada.
The Company is a product-focused biopharmaceutical company developing therapeutics for disease indications with large markets. The Company’s lead technologies are focused on the treatment of agitation and aggression in Alzheimer’s disease and diabetes.
The success of the Company is dependent on bringing its products to market, obtaining the necessary regulatory approvals and achieving future profitable operations. The continuation of the research and development activities and the commercialization of its products are dependent on the Company’s ability to successfully complete these activities and to obtain adequate financing through a combination of financing activities and operations. It is not possible to predict either the outcome of future research and development programs or the Company’s ability to fund these programs going forward.
These consolidated financial statements have been prepared in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board for interim financial statements, including IAS 34 Interim Financial Reporting. The consolidated financial statements have been prepared using the historical cost convention except for the revaluation of contingent consideration payable to fair value.
The preparation of financial statements in conformity with IFRS requires use of certain critical accounting estimates. It also requires management to exercise its judgment in the process of applying the Company’s accounting policies. The areas involving a higher degree of judgment or complexity, or areas where assumptions and estimates are significant to the consolidated financial statements are disclosed in the annual consolidated financial statements for the year ended June 30, 2015.
| 3. | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
The Board of Directors approved the interim consolidated financial statements for issuance on February 5, 2016. The significant accounting policies that have been applied in the preparation of these interim consolidated financial statements are described in the Company’s annual financial statements for the year ended June 30, 2015 and have been applied to all periods presented.
IFRS issued but not yet adopted by the Company are disclosed in the Company’s annual financial statements for the year ended June 30, 2015 except as follows:
On January 13, 2016, the International Accounting Standards Board issued IFRS 16, Leases which replaces the current guidance in IAS 17, Leases. IFRS 16 requires lessees to recognize a lease liability reflecting future lease payments and a right of use asset for virtually all lease contracts. IFRS 16 must be applied to an entity’s first annual IFRS financial statements for periods beginning on or after January 1, 2019, with early adoption permitted. Management is evaluating the standard and has not yet determined the impact on its consolidated financial statements.
Notes to the Audited Consolidated Financial Statements
December 31, 2015
(Unaudited in Canadian Dollars)
| 4. | FINANCIAL RISK MANAGEMENT |
4.1 Categories of financial assets and liabilities
All financial instruments are measured at amortized cost except for the contingent consideration payable which is measured at fair value. The following table outlines the Company’s financial instruments, their classification, carrying value and fair value.
Financial Instruments as at December 31, 2015 | | Classification | | Carrying Value ($) | | | Fair Value ($) | |
Cash | | Loans and receivables | | | 29,070,189 | | | | 29,070,189 | |
Other receivables | | Loans and receivables | | | 72,553 | | | | 72,553 | |
Trade and other payables | | Other liabilities | | | 2,064,780 | | | | 2,064,780 | |
Contingent consideration payable | | Fair value through profit and loss | | | 4,916,324 | | | | 4,916,324 | |
Financial Instruments as at June 30, 2015 | | Classification | | Carrying Value ($) | | | Fair Value ($) | |
Cash | | Loans and receivables | | | 40,510,758 | | | | 40,510,758 | |
Other receivables | | Loans and receivables | | | 265,189 | | | | 265,189 | |
Trade and other payables | | Other liabilities | | | 8,549,895 | | | | 8,549,895 | |
Contingent consideration payable | | Fair value through profit and loss | | | 4,361,601 | | | | 4,361,601 | |
The Company has determined the estimated fair values of its financial instruments based on appropriate valuation methodologies; however, considerable judgment is required to develop these estimates. The carrying value of cash, other receivables and accounts payable and accrued liabilities approximates fair value due to the short-term nature of the financial instruments.
The contingent consideration is measured at fair value based on level 3 inputs. The contingent consideration is not based on observable inputs and is measured using a discounted cash flow analysis of expected payments in future periods. The significant estimates used in the fair value calculations are as follows:
| (a) | Management has estimated the timing of the milestone payments based on current expectations and plans for the development of ELND005. The milestone payments are assigned a probability based on industry statistics for the successful development of pharmaceutical products. An increase of 10% applied to the probability assumptions, with all other variables held constant, will increase the contingent consideration payable by $1,624,168. Conversely a decrease of 10% applied to the probability assumptions, with all other variables held constant, would decrease the contingent consideration payable by $1,710,592; |
| (b) | The probability adjusted cash flows are discounted at a rate of 20% which is management’s best estimate of the Company’s cost of capital. An increase of 5% to the discount rate would decrease the contingent consideration payable by $1,191,416. Conversely, a decrease of 5% to the discount rate would increase the contingent consideration payable by $1,682,499. |
Notes to the Audited Consolidated Financial Statements
December 31, 2015
(Unaudited in Canadian Dollars)
4.2 Financial risk factors
The Company’s activities expose it to a variety of financial risks: market risk (including foreign exchange and interest rate risks), credit risk and liquidity risk. Risk management is the responsibility of the Company’s finance function which identifies, evaluates and where appropriate, mitigates financial risks.
(a) Foreign exchange risk
The Company operates in Canada and has relationships with entities in other countries. Foreign exchange risk arises from purchase transactions, as well as recognized financial assets and liabilities denominated in foreign currencies, mainly the US dollar. The Company does not enter into hedging or other contracts to mitigate its exposure to foreign exchange risk and maintains sufficient US dollars to meet the Company’s planned US dollar expenses.
Financial instruments in foreign currencies at December 31, 2015 and June 30, 2015 are approximately:
| | December 31, 2015 | | | June 30, 2015 | |
| | US$ | | | US$ | |
Cash | | | 19,269,111 | | | | 30,544,014 | |
Trade and other payables | | | (276,245 | ) | | | (102,464 | ) |
| | | 18,992,866 | | | | 30,441,550 | |
Fluctuations in the US dollar exchange rate could potentially have a significant impact on the Company’s results. At December 31, 2015, if the Canadian dollar weakened 10% against the US dollar, with all other variables held constant, comprehensive loss for the six month period ended December 31, 2015 would have decreased by approximately $1,581,000. Conversely, if the Canadian dollar strengthened 10% against the US dollar, with all other variables held constant, comprehensive loss for the six month period ended December 31, 2015 would have increased by approximately $1,581,000.
(b) Liquidity risk
Liquidity risk is the risk that the Company will not be able to meet its obligations as they become due.
The Company’s investment policies are designed to maintain safety of principal and provide sufficient readily available cash in order to meet liquidity requirements. The Company manages its liquidity risk by forecasting cash flows from operations and anticipated investing and financing activities. All cash and short term investments have maturities less than one year.
At December 31, 2015 the Company’s financial liabilities which include trade and other payables are current and are expected to be repaid within 1 to 3 months of the period end date.
If all contingencies are satisfied, the contingent consideration payable is expected to be paid as follows:
Fiscal year ending June 30, 2017 | | $ | 2,847,759 | |
Fiscal year ending June 30, 2021 | | $ | 3,797,096 | |
Fiscal year ending June 30, 2022 | | $ | 18,111,664 | |
Fiscal year ending June 30, 2023 | | $ | 20,760,000 | |
Fiscal year ending June 30, 2024 | | $ | 20,760,000 | |
Notes to the Audited Consolidated Financial Statements
December 31, 2015
(Unaudited in Canadian Dollars)
| 4.3 | Capital risk management |
The Company’s primary objective when managing capital is to ensure its ability to continue as a going concern in order to pursue the development of its drug candidates and the out-license of these drug candidates to pharmaceutical companies. The Company attempts to maximize return to shareholders by minimizing shareholder dilution and, when possible, utilizing non-dilutive arrangements such as collaborative partnership arrangements.
The Company includes equity comprised of issued share capital, warrants, contributed surplus and deficit in the definition of capital. The Company has financed its capital requirements primarily through share issuances since inception and collaborative partnership agreements.
The Company manages its capital structure and makes adjustments to it in light of changes in economic conditions and risk characteristics of the underlying assets. The Company monitors its cash requirements and market conditions to anticipate the timing of requiring additional capital to finance the development of its drug candidates. The Company is not subject to externally imposed capital requirements and there has been no change with respect to the overall capital management strategy during the six month period ended December 31, 2015 from the year ended June 30, 2015.
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 beyond the next 12 months. However, the Company’s working capital may not be sufficient to meet its stated business objectives in the event of unforeseen circumstances or a change in the strategic direction of the Company. When, or if, the Company requires additional capital, there can be no assurance that the Company will be able to obtain further financing on favourable terms, if at all.
Intangible assets consist of the following:
| | ENI Technology acquired (ELND005) | | | Lilly Licenses acquired (TT401/402) | | | Lilly SARM License acquired (TT701) | | | Total | |
| | $ | | | $ | | | $ | | | $ | |
As at July 1, 2015 | | | | | | | | | | | | | | | | |
Cost | | | 20,547,993 | | | | 1,055,900 | | | | 624,500 | | | | 22,228,393 | |
Accumulated amortization | | | (13,919,829 | ) | | | (282,019 | ) | | | (4,162 | ) | | | (14,206,010 | ) |
Net book value July 1, 2015 | | | 6,628,164 | | | | 773,881 | | | | 620,338 | | | | 8,022,383 | |
As at December 31, 2015 | | | | | | | | | | | | | | | | |
Cost | | | 20,547,993 | | | | 1,055,900 | | | | 692,000 | | | | 22,295,893 | |
Accumulated amortization | | | (14,195,999 | ) | | | (308,417 | ) | | | (32,289 | ) | | | (14,536,705 | ) |
Net book value December 31, 2015 | | | 6,351,994 | | | | 747,483 | | | | 659,711 | | | | 7,759,188 | |
Period ended December 31, 2015 | | | | | | | | | | | | | | | | |
Opening net book value | | | 6,628,164 | | | | 773,881 | | | | 620,338 | | | | 8,022,383 | |
Amortization charge | | | (276,170 | ) | | | (26,398 | ) | | | (28,127 | ) | | | (330,695 | ) |
Foreign exchange | | | - | | | | - | | | | 67,500 | | | | 67,500 | |
Net book value December 31, 2015 | | | 6,351,994 | | | | 747,483 | | | | 659,711 | | | | 7,759,188 | |
Notes to the Audited Consolidated Financial Statements
December 31, 2015
(Unaudited in Canadian Dollars)
| | Technology acquired (ELND005) | | | Lilly Licenses acquired (TT401/402) | | | Lilly SARM License acquired (TT701) | | | Total | |
| | $ | | | $ | | | $ | | | $ | |
| | | | | | | | | | | | | | | | |
As at July 1, 2014 | | | | | | | | | | | | | | | | |
Cost | | | 20,547,993 | | | | 1,055,900 | | | | - | | | | 21,603,893 | |
Accumulated amortization | | | (13,367,489 | ) | | | (229,223 | ) | | | - | | | | (13,596,712 | ) |
Net book value | | | 7,180,504 | | | | 826,677 | | | | - | | | | 8,007,181 | |
| | | | | | | | | | | | | | | | |
As at June 30, 2015 | | | | | | | | | | | | | | | | |
Cost | | | 20,547,993 | | | | 1,055,900 | | | | 624,500 | | | | 22,228,393 | |
Accumulated amortization | | | (13,919,829 | ) | | | (282,019 | ) | | | (4,162 | ) | | | (14,206,010 | ) |
Net book value June 30, 2015 | | | 6,628,164 | | | | 773,881 | | | | 620,338 | | | | 8,022,383 | |
| | | | | | | | | | | | | | | | |
Year ended June 30, 2015 | | | | | | | | | | | | | | | | |
Opening net book value | | | 7,180,504 | | | | 826,677 | | | | - | | | | 8,007,181 | |
Acquisition of intangible assets | | | - | | | | - | | | | 624,500 | | | | 624,500 | |
Amortization charge | | | (552,340 | ) | | | (52,796 | ) | | | (4,162 | ) | | | (609,298 | ) |
Net book value June 30, 2015 | | | 6,628,164 | | | | 773,881 | | | | 620,338 | | | | 8,022,383 | |
The amortization of all intangible assets relates to the research and development efforts of the Company and has therefore been included in the “research and development” line in the consolidated statement of comprehensive loss.
| 6. | TRADE AND OTHER PAYABLES |
Trade and other payables consist of the following:
| | December 31, 2015 | | | June 30, 2015 | |
| | $ | | | $ | |
Accounts payable | | | 320,679 | | | | 2,594 | |
Accrued expenses: | | | | | | | | |
Clinical trials and manufacturing | | | 1,062,335 | | | | 7,769,521 | |
Salaries and benefits | | | 370,131 | | | | 398,017 | |
Professional fees and services | | | 208,680 | | | | 235,477 | |
Other | | | 102,955 | | | | 144,286 | |
| | | 1,744,101 | | | | 8,547,301 | |
| | | 2,064,780 | | | | 8,549,895 | |
| 7. | CONTINGENT CONSIDERATION PAYABLE |
| (a) | Under the terms of the ENI step-acquisition agreement, the Company is committed to pay the former shareholders of ENI contingent clinical milestones potentially totaling $10.9 million payable in cash or Transition common shares at the then market price and a royalty of up to 1% on net sales of the ELND005 product. The Company has recognized a liability as at December 31, 2015 of $1,502,576 (June 30, 2015 - $1,429,884) which represents the fair value of the contingent consideration payable to the former shareholders of ENI. |
Notes to the Audited Consolidated Financial Statements
December 31, 2015
(Unaudited in Canadian Dollars)
| (b) | Under the terms of the ELND005 milestone and royalty agreement, the Company is committed to pay Perrigo Company Limited contingent approval and commercialization milestones potentially totaling US$40 million and a royalty of up to 6.5% on net sales of the ELND005 product. Accordingly, the Company has recognized a liability as at December 31, 2015 of $3,413,748 (June 30, 2015 - $2,931,717) which represents the fair value of the contingent consideration payable to Perrigo. |
| | Payable to | | | Payable to | | | | |
| | ENI | | | Perrigo | | | Total | |
Contingent Consideration Payable | | $ | | | $ | | | $ | |
Balance at July 1, 2014 | | | 1,030,775 | | | | 2,807,511 | | | | 3,838,286 | |
Change in contingent consideration payable | | | 399,109 | | | | (333,322 | ) | | | 65,787 | |
Foreign exchange | | | - | | | | 457,528 | | | | 457,528 | |
Balance at June 30, 2015 | | | 1,429,884 | | | | 2,931,717 | | | | 4,361,601 | |
Change in contingent consideration payable | | | 72,692 | | | | 157,730 | | | | 230,422 | |
Foreign exchange | | | - | | | | 324,301 | | | | 324,301 | |
Balance at December 31, 2015 | | | 1,502,576 | | | | 3,413,748 | | | | 4,916,324 | |
Significant assumptions and the sensitivity of changes to these assumptions are discussed in Note 4.
| 8. | LICENSING AND COLLABORATION AGREEMENTS WITH ELI LILLY AND COMPANY |
| (a) | On March 3, 2010, Transition and Eli Lilly and Company (“Lilly”) entered into a licensing and collaboration agreement granting Transition the rights to a series of preclinical compounds in the area of diabetes. Under the licensing and collaboration agreement, Transition will receive exclusive worldwide rights to develop and potentially commercialize a class of compounds that, in preclinical models showed potential to provide glycemic control and other beneficial effects including weight loss. |
Under the terms of the agreement, Lilly received an up-front payment of US$1 million and retained the option to reacquire the rights to the compounds at a later date. The up-front payment of $1,055,900 (US$1 million) has been capitalized as a license acquired from Lilly and will be amortized over 20 years which represents the estimated remaining life of the underlying compounds and patents.
In June 2013, Lilly exercised their option and assumed all development and commercialization rights to type 2 diabetes drug candidate TT401. In conjunction with this assumption of rights, Transition received a milestone payment of $7,118,300 (US$7 million) which has been recognized as revenue during the year ended June 30, 2013. Lilly has assumed all costs and will perform all future development and commercialization activities of TT401. In fiscal 2015, Transition has paid US$14 million ($15,491,600) to Lilly in three separate installments during the Phase 2 clinical study. In return, Transition is eligible to receive up to approximately US$240 million in additional milestone payments and will also be eligible to receive a double-digit royalty on sales of TT401 products and a low single digit royalty on related compounds. The Company has no further funding obligations under the Agreement.
| (b) | On May 6, 2015, the Company, through its wholly owned subsidiary Transition Therapeutics Ireland Limited (“TTIL”), exclusively licensed worldwide rights to a novel small molecule drug candidate, TT701 from Lilly. Under the terms of the agreement, TTIL has acquired the rights to develop and commercialize TT701. Transition will pay Lilly upfront consideration of up to US$1 million. As of June 30, 2015, Transition has paid Lilly $624,500 (US$500,000) of the upfront consideration and this payment has been capitalized as a license acquired from Lilly and will be amortized over the estimated remaining life of 12.5 years. The remaining upfront payment of US$500,000 is due upon first patient enrollment in a clinical trial and is expected to be paid in fiscal 2016 once the milestone is achieved. |
Notes to the Audited Consolidated Financial Statements
December 31, 2015
(Unaudited in Canadian Dollars)
At December 31, 2015, the authorized share capital of the Company consists of an unlimited number of no par value common shares. The common shares are voting and are entitled to dividends if, as and when declared by the Board of Directors.
| [b] | Common shares issued and outstanding during the period |
At December 31, 2015, there were 38,878,879 common shares issued and outstanding [June 30, 2015 – 38,878,879].
Warrants
Details of whole warrants outstanding at December 31, 2015 are as follows:
| | | | | Fair Value at Date of Issuance | | | Expiry |
Warrants | | # | | | $ | | | Date |
US$4.60 Warrants issued August 15, 2013 | | | 853,223 | | | | 1,108,107 | | | August 15, 2015 |
US$6.50 Warrants issued August 15, 2013 | | | 1,050,118 | | | | 917,732 | | | August 15, 2015 |
US$7.10 Warrants issued June 23, 2014 | | | 1,949,250 | | | | 3,150,558 | | | June 23, 2016 |
Warrants outstanding at June 30, 2015 | | | 3,852,591 | | | | 5,176,397 | | | |
US$4.60 Warrants expired August 15, 2015 | | | (853,223 | ) | | | (1,108,107 | ) | | |
US$6.50 Warrants expired August 15, 2015 | | | (1,050,118 | ) | | | (917,732 | ) | | |
Warrants outstanding at December 31, 2015 | | | 1,949,250 | | | | 3,150,558 | | | |
On August 15, 2015, the warrants issued on August 15, 2013 expired unexercised and accordingly, the carrying value of the expired warrants of $2,025,839 was reclassified to contributed surplus during the three month period ending September 30, 2015.
The remaining warrants outstanding at December 31, 2015 have a total fair value at date of issuance of $3,150,558 which was calculated using the Black-Scholes pricing model.
| | | | | | | | Weighted Average Exercise Price | |
Stock options | | # | | | $ | | | $ | |
Stock options outstanding, July 1, 2015 | | | 2,755,764 | | | | 5,892,305 | | | | 4.82 | |
Stock options expired [i] | | | (175,000 | ) | | | (372,400 | ) | | | 3.48 | |
Stock options forfeited or cancelled [ii] | | | (172,384 | ) | | | - | | | | 7.16 | |
Stock based compensation expense | | | - | | | | 952,475 | | | | - | |
Stock options outstanding, December 31, 2015 | | | 2,408,380 | | | | 6,472,380 | | | | 4.75 | |
Notes to the Audited Consolidated Financial Statements
December 31, 2015
(Unaudited in Canadian Dollars)
| | | | | | | | Weighted Average Exercise Price | |
Stock options | | # | | | $ | | | $ | |
Stock options outstanding, July 1, 2014 | | | 2,305,589 | | | | 2,866,292 | | | | 3.91 | |
Stock options issued [iii] | | | 45,000 | | | | - | | | | 7.53 | |
Stock options exercised [iv] | | | (12,170 | ) | | | (18,535 | ) | | | 2.18 | |
Stock options forfeited or cancelled [ii] | | | (18,484 | ) | | | - | | | | 5.58 | |
Stock based compensation expense | | | | | | | 1,565,220 | | | | - | |
Stock options outstanding, December 31, 2014 | | | 2,319,935 | | | | 4,412,977 | | | | 3.97 | |
| [i] | During the six month period ended December 31, 2015, 175,000 stock options expired unexercised. These stock options had a fair value of $372,400 which was reclassified to contributed surplus. |
| [ii] | During the six month period ended December 31, 2015, 172,384 stock options were cancelled. These options had a fair value of $885,865 and were unvested at the time of cancellation. During the six month period ended December 31, 2014, 18,484 stock options were forfeited. These options had a fair value of $75,971 and were unvested at the time of forfeit. |
| [iii] | No stock options were issued during the six month period ended December 31, 2015. The fair value of the 45,000 stock options issued during the six month period ended December 31, 2014 was $248,411. |
| [iv] | No stock options were exercised during the six month period ended December 31, 2015. During the six month period ended December 31, 2014, 12,170 stock options were exercised. These options had a fair value of $18,535 and resulted in cash proceeds to the Company of $26,229. |
| [v] | The maximum possible cash proceeds to the Company from the exercise of the stock options outstanding at December 31, 2015 are $11,430,633 [June 30, 2015 - $13,274,428]. |
| | Six month period ended December 31, 2015 | | | Six month period ended December 31, 2014 | | | Three month period ended December 31, 2015 | | | Three month period ended December 31, 2014 | |
| | $ | | | $ | | | $ | | | $ | |
Research and development | | | | | | | | | | | | | | | | |
Clinical trials and manufacturing | | | 4,285,705 | | | | 28,671,103 | | | | 648,649 | | | | 14,356,285 | |
Salaries and benefits | | | 1,372,201 | | | | 1,794,558 | | | | 520,917 | | | | 911,258 | |
Stock compensation expense | | | 175,420 | | | | 869,778 | | | | 211,407 | | | | 359,889 | |
Depreciation and amortization | | | 329,001 | | | | 310,687 | | | | 164,632 | | | | 155,343 | |
Facility lease costs and utilities | | | 141,581 | | | | 148,953 | | | | 71,249 | | | | 63,573 | |
Insurance | | | 33,273 | | | | 101,911 | | | | 17,601 | | | | 44,833 | |
General laboratory supplies and materials | | | 51,245 | | | | 128,451 | | | | 28,491 | | | | 56,876 | |
Ontario investment tax credits | | | - | | | | (85,661 | ) | | | - | | | | (43,168 | ) |
| | | 6,388,426 | | | | 31,939,780 | | | | 1,662,946 | | | | 15,904,889 | |
| | | | | | | | | | | | | | | | |
Selling, general and administrative expenses | | | | | | | | | | | | | | | | |
Salaries and benefits | | | 909,756 | | | | 839,900 | | | | 444,825 | | | | 422,939 | |
Professional fees and services | | | 249,419 | | | | 357,716 | | | | 122,314 | | | | 159,248 | |
Insurance | | | 130,693 | | | | 129,316 | | | | 69,111 | | | | 67,139 | |
Stock compensation expense | | | 777,055 | | | | 695,442 | | | | 323,553 | | | | 313,677 | |
Facility lease costs and utilities | | | 80,704 | | | | 76,238 | | | | 42,420 | | | | 38,119 | |
Business development, corporate communication and investor relations | | | 186,991 | | | | 204,706 | | | | 121,827 | | | | 89,120 | |
Regulatory and stock transfer fees | | | 40,717 | | | | 54,501 | | | | 13,274 | | | | 26,716 | |
Office and related expenses | | | 121,321 | | | | 127,986 | | | | 59,178 | | | | 70,096 | |
Business taxes | | | 79,000 | | | | - | | | | 477 | | | | - | |
Depreciation and amortization | | | 43,546 | | | | 23,476 | | | | 21,815 | | | | 16,395 | |
| | | 2,619,202 | | | | 2,509,281 | | | | 1,218,794 | | | | 1,203,449 | |
| 11. | EARNINGS (LOSS) PER SHARE |
Basic and diluted loss per share is calculated by dividing the loss attributable to equity holders of the Company by the weighted average number of common shares outstanding during the period. Outstanding options to purchase common shares of 2,408,380 [December 31, 2014 – 2,319,935] and warrants of 1,949,250 [December 31, 2014 – 3,852,591] are not included in the calculation of diluted loss per share as the effect is anti-dilutive due to losses incurred in the six and three month periods ended December 31, 2015 and 2014.
For the six and three month periods ended December 31, 2015 and 2014, 79,908 contingently returnable common shares were excluded from the basic and diluted net loss per common share calculation. The contingently returnable common shares relate to employment contracts and will be released from escrow based on the achievement of certain corporate milestones.
| | Six month period ended December 31, 2015 | | | Six month period ended December 31, 2014 | | | Three month period ended December 31, 2015 | | | Three month period ended December 31, 2014 | |
Loss attributable to equity holders of the Company | | $ | (6,497,236 | ) | | $ | (32,605,463 | ) | | $ | (2,005,780 | ) | | $ | (16,910,139 | ) |
| | | | | | | | | | | | | | | | |
Weighted average number of common shares outstanding | | | 38,798,971 | | | | 35,227,705 | | | | 38,798,971 | | | | 35,229,357 | |
| 12. | CONTINGENCIES AND COMMITMENTS |
At December 31, 2015, the Company is committed to aggregate expenditures of approximately $1,993,000 [June 30, 2015 - $3,541,000] for clinical and toxicity studies to be completed during fiscal 2016, approximately $51,000,[June 30, 2015 - $215,000] for manufacturing agreements and approximately $156,000 [June 30, 2015 - $327,000] for consulting and other agreements.
The Company may also be required to pay commercial milestone payments of US$10,000,000 to Brigham and Women’s Hospital in respect of TT701.
Notes to the Audited Consolidated Financial Statements
December 31, 2015
(Unaudited in Canadian Dollars)
| 13. | CHANGE IN WORKING CAPITAL |
The change in working capital consists of the following:
| | Six month period ended December 31, 2015 | | | Six month period ended December 31, 2014 | | | Three month period ended December 31, 2015 | | | Three month period ended December 31, 2014 | |
| | $ | | | $ | | | $ | | | $ | |
Other receivables | | | 192,636 | | | | (1,167,342 | ) | | | 257,607 | | | | (1,183,648 | ) |
Income tax and investment tax credits receivable | | | - | | | | (272,936 | ) | | | - | | | | (230,443 | ) |
Prepaid expenses and deposits | | | (69,778 | ) | | | (204,402 | ) | | | 127,039 | | | | 85,026 | |
Trade and other payables | | | (6,939,502 | ) | | | (2,006,111 | ) | | | (1,858,409 | ) | | | (2,089,552 | ) |
| | | (6,816,644 | ) | | | (3,650,791 | ) | | | (1,473,763 | ) | | | (3,418,617 | ) |
| 14. | RELATED PARTY TRANSACTIONS |
Key management compensation
Key management includes the Company’s directors, and members of the senior management team. The compensation paid or payable to key management for employee services is show below:
| | Six month period ended December 31, 2015 | | | Six month period ended December 31, 2014 | | | Three month period ended December 31, 2015 | | | Three month period ended December 31, 2014 | |
| | $ | | | $ | | | $ | | | $ | |
Salaries and other short-term employee benefits | | | 851,826 | | | | 1,046,777 | | | | 373,912 | | | | 530,680 | |
Stock-compensation expenses | | | 780,160 | | | | 1,107,302 | | | | 405,261 | | | | 462,472 | |
Termination benefits | | | 127,542 | | | | - | | | | - | | | | - | |
| | | 1,759,528 | | | | 2,154,079 | | | | 779,173 | | | | 993,152 | |
During the three month period ended September 30, 2015, the Chief Medical Officer and the ELND005 Program Lead left the Company, which resulted in a termination payment of $127,542.
The Company operates in one operating segment, the research and development of therapeutic agents. The Company’s non-current assets are primarily located in Canada.