Sophiris Bio Reports Third Quarter Financial Results and Recent Key
Operational Highlights
SAN DIEGO, CA and VANCOUVER, BC, Nov. 12,
2012 /PRNewswire/ - 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, 2012
The 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 Costs
Research 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 Costs
General 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 Income
Interest 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 Expense
Interest 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, 2012
The 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 Costs
Research 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 Costs
General 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 Income
Interest 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 Expense
Interest 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, |
|
|
|
|
|
|
|
2012 |
2011 |
|
2012 |
2011 |
|
$ |
$ |
|
$ |
$ |
|
|
|
|
|
|
|
|
|
|
|
|
Expenses |
|
|
|
|
|
Research and development |
3,411,012 |
1,543,618 |
|
10,193,869 |
4,540,579 |
General and
administrative |
1,980,287 |
1,100,777 |
|
4,341,993 |
3,591,313 |
|
5,391,299 |
2,644,395 |
|
14,535,862 |
8,131,892 |
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
Interest income |
44,615 |
20,238 |
|
93,277 |
50,031 |
Interest expense |
(482,218) |
(421,857) |
|
(1,519,996) |
(421,857) |
Loss on disposal of assets |
- |
(11,648) |
|
- |
(11,648) |
Foreign
exchange gain (loss) |
206,131 |
83,386 |
|
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 differences |
211,203 |
(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
diluted |
163,793,203 |
122,126,537 |
|
157,102,206 |
121,660,360 |
Sophiris 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 equivalents |
15,226,029 |
|
23,410,478 |
|
Other receivables |
113,667 |
|
238,906 |
|
Prepaid expenses |
194,484 |
|
284,770 |
|
15,534,180 |
|
23,934,154 |
Non-current assets
|
|
|
|
|
Property and equipment |
184,583 |
|
219,740 |
|
Intangible assets |
- |
|
316,099 |
|
Other long term assets |
44,459 |
|
29,495 |
Total assets |
15,763,222 |
|
24,499,488 |
|
|
|
|
Liabilities |
|
|
|
|
|
|
|
Current liabilities
|
|
|
|
|
Accounts payable and accrued liabilities |
2,638,673 |
|
3,101,548 |
|
Current portion of secured promissory notes |
5,756,757 |
|
14,456,768 |
|
8,395,430 |
|
17,558,316 |
|
|
|
|
Long-term secured promissory
notes |
7,385,751 |
|
- |
|
|
|
|
Shareholders' equity
|
|
|
|
|
Common shares |
54,490,667 |
|
48,073,120 |
|
Common share purchase warrants |
7,794,477 |
|
5,926,762 |
|
Contributed Surplus |
6,120,004 |
|
5,631,987 |
|
Currency translation differences |
(69,495) |
|
(177,344) |
|
Deficit |
(68,353,612) |
|
(52,513,353) |
|
Total shareholders' (deficit) equity |
(17,959) |
|
6,941,172 |
Total 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 compensation |
488,017 |
|
719,993 |
|
Accretion expense |
486,747 |
|
132,986 |
|
Depreciation of property and
equipment |
60,735 |
|
25,551 |
|
Amortization of intangible
assets |
149,222 |
|
152,897 |
|
Impairment loss |
175,766 |
|
- |
|
Loss on disposal of assets |
- |
|
11,648 |
|
Unrealized foreign exchange
(gain) |
(109,071) |
|
(38,955) |
|
Interest expense |
1,033,250 |
|
186,042 |
|
Interest income |
(93,277) |
|
(46,780) |
Change in non-cash
working capital: |
|
|
|
|
Other receivables |
142,221 |
|
95,784 |
|
Prepaid expenses |
90,451 |
|
(277,738) |
|
Other long term assets |
(14,643) |
|
(573,381) |
|
Accounts payable and accrued
liabilities |
(608,144) |
|
366,746 |
|
Accrued interest |
(14,258) |
|
118,750 |
Net cash flows used in
operating activities |
(14,053,243) |
|
(7,648,691) |
|
|
|
|
Cash flows from
(used in) investing activities |
|
|
|
Interest received
|
82,440 |
|
46,780 |
Purchase 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) |
- |
|
14,645,048 |
Issuance 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 |
- |
|
77,895 |
Issuance of common
shares on exercise of stock options |
- |
|
302,481 |
Principal 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 equivalents |
375,278 |
|
(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.