YM BioSciences Reports Operational and Financial Results for the Second Quarter of Fiscal 2012
MISSISSAUGA, ON, Feb. 9, 2012 /PRNewswire/ - YM BioSciences Inc. (NYSE Amex: YMI, TSX: YM), a drug development company advancing a diverse portfolio of hematology and cancer related products, today reported operational and financial results for its second quarter of fiscal 2012, ended December 31, 2011.
"JAK inhibitors may ultimately prove valuable in the treatment of a wide range of blood disorders, cancers and inflammatory diseases, representing an immense opportunity for this emerging drug class. We recently reported multicenter data for our lead JAK inhibitor, CYT387, establishing its competitive safety and efficacy profile in patients with myelofibrosis," said Dr. Nick Glover, President and CEO of YM BioSciences. "The strength of our data positions us well to select the optimal course to further advance this opportunity."
Updated results from the Phase I/II study of CYT387 in 166 patients with myelofibrosis were presented in a poster session at the 53rd Annual Meeting of the American Society of Hematology held in San Diego in December 2011. CYT387 demonstrated an ability to render and maintain anemic myelofibrosis patients transfusion independent for clinically-relevant periods while also producing significant and durable improvements in their splenomegaly and constitutional symptoms. CYT387 was generally safe and well tolerated in myelofibrosis patients for dosing periods up to and exceeding two years, with minimal treatment-related myelosuppression observed.
Financial Results (CDN dollars)
The interim consolidated financial statements and comparative information for the second quarter of fiscal 2012 have been prepared in accordance with International Financial Reporting Standards ("IFRS"). Previously, up to June 30, 2011, the Company prepared its Interim and Annual Consolidated Financial Statements in accordance with Canadian Generally Accepted Accounting Principles ("Canadian GAAP").
Revenue from out-licensing for the second quarter of fiscal 2012, ended December 31, 2011, was $0.4 million compared with $0.3 million for the second quarter of fiscal 2011. Revenue from out-licensing for the first six months of fiscal 2012 was $0.6 million and comparable to $0.6 million for the first six months of fiscal 2011.
Net finance income was $1.5 million for the second quarter of fiscal 2012 compared to net finance costs of $4.6 million for the second quarter of fiscal 2011. Net finance income was $9.0 million for the first six months of fiscal 2012 compared to net finance costs of $8.3 million for the first six months of fiscal 2011. Under IFRS, warrants denominated in a different currency than the Company's functional currency must be classified as a financial liability and measured at fair value, with changes reflected in profit or loss. The change in net finance income during the second fiscal quarter is primarily attributed to a change of $6.0 million in the fair value adjustment for USD warrants. For the first six months of fiscal 2012, the Company incurred a gain of $7.3 million compared to a loss of $7.5 million for the six months ended December 31, 2010 on the revaluation of warrants.
Licensing and product development expenses were $7.3 million for the second quarter of fiscal 2012 compared with $5.2 million for the second quarter of fiscal 2011. Licensing and product development expenses were $13.7 million for the first six months of fiscal 2012 compared with $10.9 million for the first six months of fiscal 2011. Development expenses for CYT387 increased due to the expansion of the Phase I/II clinical trial in myelofibrosis, start-up costs associated with the BID (twice-daily dosing) study, pre-clinical development activities, and manufacturing of drug for these programs. Expenses for nimotuzumab continued to decrease.
General and administrative expenses were $1.2 million for the second quarter of fiscal 2012 compared to $2.7 million for the second quarter of fiscal 2011. General and administrative expenses were $3.3 million for the first six months of fiscal 2012 compared to $5.0 million for the first six months of fiscal 2011, primarily due to severance and restructuring costs in 2010.
Net loss for the second quarter of fiscal 2012 was $6.6 million ($0.06 per share) compared to $12.3 million ($0.14 per share) for the same period last year.
As at December 31, 2011 the Company had cash and short-term deposits totaling $67.9 million and accounts payables and accrued liabilities totaling $3.7 million compared to $79.7 million and $4.4 million respectively at June 30, 2011. Management believes that the cash and short-term deposits at December 31, 2011 are sufficient to support the Company's activities for at least the next 18 months.
As at December 31, 2011 the Company had 116,711,448 common shares and 7,366,418 warrants outstanding.
About YM BioSciences
YM BioSciences Inc. is a drug development company advancing three products: CYT387, a small molecule, dual inhibitor of the JAK1/JAK2 kinases; nimotuzumab, an EGFR-targeting monoclonal antibody; and CYT997, a vascular disrupting agent (VDA).
CYT387 is an orally administered inhibitor of both the JAK1 and JAK2 kinases, which have been implicated in a number of immune cell disorders including myeloproliferative neoplasms and inflammatory diseases as well as certain cancers. Positive interim results have been reported from a Phase I/II trial of CYT387 in 166 patients with myelofibrosis. This trial has completed enrollment while a 60 patient Phase II twice-daily dose escalation trial is currently recruiting patients. Nimotuzumab is a humanized monoclonal antibody targeting EGFR with an enhanced side-effect profile over currently marketed EGFR-targeting antibodies. Nimotuzumab is being evaluated in numerous Phase II and III trials worldwide. CYT997 is an orally-available small molecule therapeutic with dual mechanisms of vascular disruption and cytotoxicity, and has completed a Phase II trial in glioblastoma multiforme. In addition to YM's three products, the Company has several preclinical research programs underway with candidates from its library of novel compounds identified through internal research conducted at YM BioSciences Australia.
This press release may contain forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process or the ability to obtain drug product in sufficient quantity or at standards acceptable to health regulatory authorities to complete clinical trials or to meet commercial demand; and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting. Certain of the assumptions made in preparing forward-looking statements include but are not limited to the following: that CYT387, nimotuzumab and CYT997 will generate positive efficacy and safety data in ongoing and future clinical trials, and that YM and its various licensees will complete their respective clinical trials and disclose data within the timelines communicated in this release. Except as required by applicable securities laws, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
YM BIOSCIENCES INC.
Condensed Consolidated Interim Statements of Financial Position
(Expressed in Canadian dollars, unless otherwise noted)
(Unaudited)
| December 31, 2011 |
June 30, 2011 |
July 1, 2010 |
|
| Assets | |||
| Current assets: | |||
| Cash and cash equivalents | $ 21,538,285 | $ 32,046,630 | $ 19,460,141 |
| Short-term deposits | 46,410,762 | 47,611,922 | 26,184,991 |
| Accounts receivable | 284,435 | 205,900 | 161,184 |
| Prepaid expenses | 491,612 | 731,676 | 237,962 |
| Total current assets | 68,725,094 | 80,596,128 | 46,044,278 |
| Non-current assets: | |||
| Property and equipment | 68,406 | 91,320 | 84,775 |
| Intangible assets | 4,883,690 | 7,137,698 | 11,645,714 |
| Total non-current assets | 4,952,096 | 7,229,018 | 11,730,489 |
| Total assets | $ 73,677,190 | $ 87,825,146 | $ 57,774,767 |
| Liabilities and Equity | |||
| Current liabilities: | |||
| Accounts payable | $ 1,537,001 | $ 1,718,893 | $ 699,277 |
| Accrued liabilities | 2,170,038 | 2,652,511 | 2,085,824 |
| Share purchase warrants | 7,212,460 | 14,476,681 | 6,358,480 |
| Deferred revenue | 594,072 | 594,072 | 1,523,916 |
| Total current liabilities | 11,513,571 | 19,442,157 | 10,667,497 |
| Non-current liabilities: | |||
| Deferred revenue | 1,534,686 | 1,831,722 | 1,650,909 |
| Total non-current liabilities | 1,534,686 | 1,831,722 | 1,650,909 |
| Equity: | |||
| Share capital | 264,586,651 | 264,548,643 | 203,498,239 |
| Contributed surplus | 16,636,188 | 15,144,062 | 14,232,353 |
| Deficit | (220,593,906) | (213,141,438) | (172,274,231) |
| Total equity | 60,628,933 | 66,551,267 | 45,456,361 |
| Total liabilities and equity | $ 73,677,190 | $ 87,825,146 | $ 57,774,767 |
Approved by the Board and authorized for issue on February 8, 2012:
Tryon Williams, Director
David G.P. Allan, Director
YM BIOSCIENCES INC.
Condensed Consolidated Interim Statements of Comprehensive Income
(Expressed in Canadian dollars, unless otherwise noted)
(Unaudited)
| Three months ended December 31, |
Six months ended December 31, |
||||
| 2011 | 2010 | 2011 | 2010 | ||
| Revenue: | |||||
| Out-licensing | $ 380,117 | $ 251,417 | $ 630,845 | $ 593,773 | |
| Expenses: | |||||
| Licensing and product development | 7,260,481 | 5,246,698 | 13,748,328 | 10,938,754 | |
| General and administrative | 1,154,883 | 2,742,199 | 3,315,031 | 4,954,611 | |
| 8,415,364 | 7,988,897 | 17,063,359 | 15,893,365 | ||
| Loss before the undernoted | (8,035,247) | (7,737,480) | (16,432,514) | (15,299,592) | |
| Finance income | 2,058,174 | 86,892 | 8,980,046 | 149,498 | |
| Finance costs | (580,705) | (4,679,605) | - | (8,498,335) | |
| Other income | - | 24,916 | - | 24,916 | |
| Net loss for the period and comprehensive loss | $ (6,557,778) | $ (12,305,277) | $ (7,452,468) | $ (23,623,513) | |
| Basic and diluted loss per common share | $ (0.06) | $ (0.14) | $ (0.06) | $ (0.29) | |
YM BIOSCIENCES INC.
Condensed Consolidated Interim Statements of Changes in Equity
(Expressed in Canadian dollars, unless otherwise noted)
(Unaudited)
| Share capital | Contributed | ||||
| Number | Amount | surplus | Deficit | Total | |
| Balance, July 1, 2010 | 80,359,623 | $ 203,498,239 | $ 14,232,353 | $ (172,274,231) | $ 45,456,361 |
| Net loss for the period | - | - | - | (23,623,513) | (23,623,513) |
| Transactions with owners of the Company, recognized directly in equity: |
|||||
| Share-based compensation | - | - | 1,044,198 | - | 1,044,198 |
| Shares issued on exercise of options | 319,309 | 425,589 | (171,780) | - | 253,809 |
| Shares issued on exercise of warrants | 527,343 | 1,599,312 | - | - | 1,599,312 |
| Shares issued pursuant to prospectus offering | 28,750,000 | 43,334,523 | - | - | 43,334,523 |
| Total transactions with owners of the Company | 29,596,652 | 45,359,424 | 872,418 | - | 46,231,842 |
| Balance, December 31, 2010 | 109,956,275 | $ 248,857,663 | $ 15,104,771 | $ (195,897,744) | $ 68,064,690 |
| Share capital | Contributed | ||||
| Number | Amount | surplus | Deficit | Total | |
| Balance, June 30, 2011 | 116,681,948 | $ 264,548,643 | $ 15,144,062 | $ (213,141,438) | $ 66,551,267 |
| Net loss for the period | - | - | - | (7,452,468) | (7,452,468) |
| Transactions with owners of the Company, recognized directly in equity: |
|||||
| Share-based compensation | - | - | 1,507,684 | - | 1,507,684 |
| Shares issued on exercise of options | 29,500 | 38,008 | (15,558) | - | 22,450 |
| Total transactions with owners of the Company | 29,500 | 38,008 | 1,492,126 | - | 1,530,134 |
| Balance, December 31, 2011 | 116,711,448 | $ 264,586,651 | $ 16,636,188 | $ (220,593,906) | $ 60,628,933 |
YM BIOSCIENCES INC.
Condensed Consolidated Interim Statements of Cash Flows
(Expressed in Canadian dollars, unless otherwise noted)
(Unaudited)
| Three months ended December 31, |
Six months ended December 31, |
|||||||||||
| 2011 | 2010 | 2011 | 2010 | |||||||||
| Cash provided by (used in): | ||||||||||||
| Operating activities: | ||||||||||||
| Net loss for the period | $ | (6,557,778) | $ | (12,305,277) | $ | (7,452,468) | $ | (23,623,513) | ||||
| Items not involving cash: | ||||||||||||
| Depreciation of property and equipment | 16,550 | 19,789 | 33,134 | 39,147 | ||||||||
| Amortization of intangible assets | 1,127,004 | 1,127,004 | 2,254,008 | 2,254,008 | ||||||||
| Interest earned | (154,692) | (82,740) | (309,168) | (138,375) | ||||||||
| Unrealized (gain) loss on cash and cash equivalents | 576,919 | 601,654 | (1,406,658) | 1,010,362 | ||||||||
| Gain on disposal of property and equipment | - | - | - | (10,744) | ||||||||
| Share-based compensation | 442,030 | 408,145 | 1,507,684 | 1,044,198 | ||||||||
| Change in fair value of share purchase warrants | (1,903,482) | 4,076,077 | (7,264,221) | 7,487,973 | ||||||||
| Changes in non-cash working capital balances: | ||||||||||||
| Short-term deposits | (139,972) | (66,524) | (305,277) | (106,367) | ||||||||
| Accounts receivable | (17,069) | (37,156) | (78,535) | (41,979) | ||||||||
| Prepaid expenses | 64,352 | (370,250) | 240,064 | (256,716) | ||||||||
| Accounts payable | (319,915) | 718,772 | (181,892) | 712,684 | ||||||||
| Accrued liabilities | (393,750) | 631,723 | (482,473) | 1,528,885 | ||||||||
| Deferred revenue | (148,518) | (148,518) | (297,036) | (451,995) | ||||||||
| Net cash used in operating activities | (7,408,321) | (5,427,301) | (13,742,838) | (10,552,432) | ||||||||
| Investing activities: | ||||||||||||
| Proceeds from sale of short-term deposits | 33,988,017 | 20,202,541 | 35,806,437 | 48,854,217 | ||||||||
| Purchase of short-term deposits | (33,500,000) | (48,514,540) | (34,300,000) | (76,014,540) | ||||||||
| Interest earned | 154,692 | 82,740 | 309,168 | 138,375 | ||||||||
| Additions to property and equipment | (5,920) | - | (10,220) | (52,694) | ||||||||
| Net cash provided by (used in) investing activities | 636,789 | (28,229,259) | 1,805,385 | (27,074,642) | ||||||||
| Financing activities: | ||||||||||||
| Issuance of common shares on exercise of options | - | 238,809 | 22,450 | 253,809 | ||||||||
| Issue of common shares on exercise warrants | - | 850,159 | - | 850,159 | ||||||||
| Net proceeds from issuance of shares | - | 43,334,523 | - | 43,334,523 | ||||||||
| Net cash provided by financing activities | - | 44,423,491 | 22,450 | 44,438,491 | ||||||||
| Impact of foreign exchange rates on cash | (576,919) | (601,654) | 1,406,658 | (1,010,362) | ||||||||
| Increase (decrease) in cash and cash equivalents | (7,348,451) | 10,165,277 | (10,508,345) | 5,801,055 | ||||||||
| Cash and cash equivalents, beginning of period | 28,886,736 | 15,095,919 | 32,046,630 | 19,460,141 | ||||||||
| Cash and cash equivalents, end of period | $ | 21,538,285 | $ | 25,261,196 | $ | 21,538,285 | $ | 25,261,196 | ||||
SOURCE YM BioSciences Inc.
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