The Globe and Mail

Go to the Globe and Mail homepage

Jump to main navigationJump to main content

Globe Investor

News Sources

Take control of your investments with the latest investing news and analysis

Press release from CNW Group

Sophiris Bio Reports Third Quarter Financial Results and Recent Key Operational Highlights

Monday, November 12, 2012

Sophiris Bio Reports Third Quarter Financial Results and Recent Key Operational Highlights17:00 EST Monday, November 12, 2012SAN DIEGO, CA and VANCOUVER, BC, Nov. 12, 2012 /CNW/ - Sophiris Bio Inc. (TSX:SHS) ("Sophiris"), a urology company developing a late-stage, highly targeted treatment for benign prostatic hyperplasia (BPH or enlarged prostate), today announced financial results and recent key operational highlights for the third quarter ended September 30, 2012.Recent Key Operational Highlights The 12 month data from the Phase 2b study (TRIUMPH) of PRX302 has been accepted for publication by the Journal of Urology and is currently available online at: www.jurology.com/article/S0022-5347(12)05468-7/abstract.In the 12 month Phase 2b (TRIUMPH) study, patients receiving PRX302 for the treatment of BPH experienced a clinically significant improvement in the subjective symptom score (International Prostate Symptom Score, or IPSS) and the objective measure of mean peak urinary flow rate (Qmax) sustained over 12 months.The Company released data from its transrectal safety study demonstrating that PRX302 was well tolerated through three months following a transrectal injection. The results support the use of a transrectal ultrasound (TRUS) guided injection for the delivery of PRX302 directly into the prostate. This route of administration will be used in future clinical trials of PRX302 in patients with BPH.The Company announced the appointment of Randall E. Woods as Chief Executive Officer effective August 16, 2012. Mr. Woods brings almost 40 years of relevant industry experience to Sophiris, including past roles as CEO at NovaCardia Inc. (acquired by Merck & Co in 2007) and Corvas International (acquired by Dendreon in 2003).Financial Results for the Quarter Ended September 30, 2012The Company reported a net loss of $5.6 million ($0.03 per share) for the three months ended September 30, 2012, compared to a net loss of $3.0 million ($0.02 per share) for the three months ended September 30, 2011, representing an increase of $2.6 million. The increase in net loss was driven primarily from an increase in total operating expenses over the same period in 2011 as a result of our increased research and development activities of PRX302, principally our on-going transrectal study and clinical material manufacturing expenses.Research and Development CostsResearch and development costs were $3.4 million for the three months ended September 30, 2012, versus $1.5 million for the three months ended September 30, 2011, an increase of $1.9 million. The increase in research and development expenses is primarily attributable to the PRX302 clinical program, specifically the ongoing transrectal study and clinical material manufacturing expenses.General and Administrative CostsGeneral and administrative costs for the three months ended September 30, 2012, were $2.0 million, an increase of $0.9 million from the $1.1 million incurred during the three months ended September 30, 2011. The increase in general and administrative expenses is primarily related to an increase in market research costs and to a lesser extent an increase in personnel related costs associated with the build-out of our San Diego headquarters.Interest IncomeInterest income increased approximately $25,000 in the three months ended September 30, 2012, compared to the three months ended September 30, 2011. The increase in interest income was due to an increase in the average cash balance invested in interest bearing accounts during the three months ended September 30, 2012 compared to the prior period.Interest ExpenseInterest expense for the three months ended September 30, 2012, was $0.5 million, an increase of $0.1 million from the $0.4 million incurred during the three months ended September 30, 2011. The interest expense recorded by the Company is related to the Company's secured promissory note with Oxford Financial LLC. The secured promissory note was originated during July 2011 and therefore the increase in the interest expense from the three months ended September 30, 2011 to September 30, 2012 is the result of the promissory note being outstanding for the entire three months during 2012.Financial Results for the Nine Months Ended September 30, 2012The Company reported a net loss of $15.8 million ($0.10 per share) for the nine months ended September 30, 2012, compared to a net loss of $8.5 million ($0.07 per share) for the nine months ended September 30, 2011, representing an increase of $7.3 million. The increase in net loss was driven primarily from an increase in total operating expenses of $6.4 million over the same period in 2011, as a result of our increased research and development activities of PRX302, principally our on-going transrectal study and clinical material manufacturing expenses.Research and Development CostsResearch and development costs were $10.2 million for the nine months ended September 30, 2012, versus $4.5 million for the nine months ended September 30, 2011, an increase of $5.7 million. The increase in research and development expenses is primarily attributable to the PRX302 clinical program, specifically the on-going transrectal study and clinical material manufacturing expenses.General and Administrative CostsGeneral and administrative costs for the nine months ended September 30, 2012, were $4.3 million, an increase of $0.7 million from the $3.6 million incurred during the nine months ended September 30, 2011. For the nine months ended September 30, 2011, included as a component of our general and administrative expenses is $0.7 million of severance related costs associated with the shut-down of our Vancouver operations. When the severance related costs are excluded from our operating results for the nine months ended September 30, 2011, our general and administrative expenses increased $1.4 million for the nine months ended September 30, 2012 compared to the same period in 2011. This increase primarily relates to an increase in personnel related costs associated with the build-out of our San Diego headquarters, market research costs and costs associated with our recent name change.Interest IncomeInterest income increased approximately $43,000 in the nine months ended September 30, 2012 compared to the nine months ended September 30, 2011. The increase in interest income was due to an increase in the average cash balance invested in interest bearing accounts during the nine months ended September 30, 2012 compared to the prior period.Interest ExpenseInterest expense for the nine months ended September 30, 2012, was $1.5 million, an increase of $1.1 million from the $0.4 million incurred during the nine months ended September 30, 2011. The interest expense recorded by the Company relates to the Company's secured promissory note with Oxford Financial LLC. The secured promissory note was originated during July 2011 and therefore the increase in the interest expense from the nine months ended September 30, 2011 to September 30, 2012 is the result of the promissory note being outstanding for the entire nine months during 2012.For complete financial results, please see our filings at www.sedar.com.About Sophiris Sophiris Bio Inc. is a urology company developing a late-stage, highly targeted treatment for benign prostatic hyperplasia (BPH or enlarged prostate), an unsatisfied market with significant demand. PRX302, the company's lead candidate for BPH, is designed to be as efficacious as pharmaceuticals, less invasive than the surgical interventions, and without the sexual side effects seen with existing treatments. Sophiris is planning to begin a pivotal trial in the first half of 2013. Sophiris is advised by world-leading urologists, backed by experienced investors, and led by a team that has achieved more than twenty drug approvals. For more information, please visit www.sophirisbio.com.Certain statements included in this press release may be considered forward-looking. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on Sophiris' current beliefs as well as assumptions made by and information currently available to Sophiris and relate to, among other things, anticipated financial performance, business prospects, strategies, regulatory developments, market acceptance and future commitments. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by Sophiris in its public securities filings; actual events may differ materially from current expectations. Sophiris disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.Sophiris Bio Inc. Condensed Consolidated Statement of Operations, Comprehensive Loss and Deficit (Stated in United States Dollars - Unaudited) For the three months ended For the nine months ended  September 30, September 30,         20122011 20122011 $$ $$                Expenses       Research and development3,411,0121,543,618 10,193,8694,540,579General and administrative1,980,2871,100,777 4,341,9933,591,313 5,391,2992,644,395 14,535,8628,131,892        Other income (expense)       Interest income44,61520,238 93,27750,031Interest expense(482,218)(421,857) (1,519,996)(421,857)Loss on disposal of assets-(11,648) -(11,648)Foreign exchange gain (loss)206,13183,386 122,322(6,868)         (231,472)(329,881) (1,304,397)(390,342)Net loss for the period(5,622,771)(2,974,276) (15,840,259)(8,522,234)Other comprehensive income        Currency translation differences211,203(507,591) 107,849(203,195)        Total comprehensive loss for the period(5,411,568)(3,481,867) (15,732,410)(8,725,429)        Deficit - Beginning of the period(62,730,841)(43,850,654) (52,513,353)(38,302,696)Deficit - End of the period(68,353,612)(46,824,930) (68,353,612)(46,824,930)Basic and diluted loss per share(0.03)(0.02) (0.10)(0.07)Weighted average number of outstanding shares-        Basic and diluted163,793,203122,126,537 157,102,206121,660,360Sophiris Bio Inc.Condensed Consolidated Statement of Financial Position (Stated in United States Dollars - Unaudited)     Restated   September 30, December 31,   2012 2011   $ $      Assets     Current assets      Cash and cash equivalents15,226,029 23,410,478 Other receivables113,667 238,906 Prepaid expenses194,484 284,770   15,534,180 23,934,154Non-current assets      Property and equipment184,583 219,740 Intangible assets-   316,099 Other long term assets44,459 29,495Total assets  15,763,222 24,499,488      Liabilities           Current liabilities      Accounts payable and accrued liabilities2,638,673 3,101,548 Current portion of secured promissory notes5,756,757 14,456,768   8,395,430 17,558,316      Long-term secured promissory notes  7,385,751 -      Shareholders' equity      Common shares54,490,667 48,073,120 Common share purchase warrants7,794,477 5,926,762 Contributed Surplus6,120,004 5,631,987 Currency translation differences(69,495) (177,344) Deficit (68,353,612) (52,513,353) Total shareholders' (deficit) equity(17,959) 6,941,172Total liabilities and shareholders' equity  15,763,222 24,499,488 Sophiris Bio Inc.Condensed Consolidated Statement of Cash Flows(Stated in United States Dollars - Unaudited) For the nine months ended September 30, 2012 2011 $ $    Cash flows used in operating activities     Net loss for the period  (15,840,259) (8,522,234)Items not affecting cash:      Stock-based compensation488,017 719,993 Accretion expense486,747 132,986 Depreciation of property and equipment60,735 25,551 Amortization of intangible assets149,222 152,897 Impairment loss175,766 -  Loss on disposal of assets-   11,648 Unrealized foreign exchange (gain)(109,071) (38,955) Interest expense1,033,250 186,042 Interest income(93,277) (46,780)Change in non-cash working capital:      Other receivables142,221 95,784 Prepaid expenses90,451 (277,738) Other long term assets(14,643) (573,381) Accounts payable and accrued liabilities(608,144) 366,746 Accrued interest(14,258) 118,750Net cash flows used in operating activities  (14,053,243) (7,648,691)    Cash flows from (used in) investing activities     Interest received  82,440 46,780Purchase of property and equipment  (25,671) (231,186)Net cash flows from (used in) investing activities  56,769 (184,406)      Cash flows from financing activities     Cash received on issuance of promissory notes (Note 8)  -  14,645,048Issuance of common shares from private placement      - net of issurance costs paid (Note 9(a))8,285,262 -  Issuance of common shares on exercise of warrants  -   77,895Issuance of common shares on exercise of stock options  -   302,481Principal payments on notes payable  (1,801,008) -  Interest paid  (1,047,507) (186,042)Net cash flows from financing activities  5,436,747 14,839,382        Effect of exchange rate changes on cash      and cash equivalents375,278 (115,340)Net increase (decrease) in cash and cash equivalents  (8,184,449) 6,890,945    Cash and cash equivalents - Beginning of the period  23,410,478 12,381,237        Cash and cash equivalents - End of the period  15,226,029 19,272,182        SOURCE: Sophiris Bio, Inc.For further information: Lauren Glaser Investor Relations The Trout Group  646-378-2972 lglaser@troutgroup.com James Beesley Investor Relations Sequoia Partners 778-389-7715 james@sequoiapartners.ca Michael Moore Investor Relations TMX Equicom 619-467-7067 mmoore@tmxequicom.com Jason I. Spark Corporate Communications Canale Communications, Inc. 619-849-6005 jason@canalecomm.com