Sophiris Bio Inc. (Sophiris, NASDAQ: SPHS, TSX: SHS) (the
“Company” or “Sophiris”), a biopharmaceutical company developing a
clinical-stage, targeted treatment for the symptoms of benign
prostatic hyperplasia (BPH or enlarged prostate), today announced
financial results and recent key operational highlights for the
three and nine months ended September 30, 2013.
Recent Key Operational Highlights
- On October 28, 2013, the Company
announced that enrollment had begun and the first patients had been
dosed in a Phase 3 clinical trial of PRX302 (topsalysin) as a
treatment for lower urinary tract symptoms of benign prostatic
hyperplasia (BPH or enlarged prostate). The Phase 3
international, multi-center trial, called the PLUS-1 study, will
enroll approximately 440 patients. The randomized, double-blind and
vehicle-controlled trial will assess the safety and efficacy of a
single intraprostatic injection of PRX302 (0.6 µg/g prostate)
for the treatment of BPH. The primary endpoint is the International
Prostate Symptom Score (IPSS) total score change from baseline over
52 weeks. Secondary endpoints include Qmax (maximum urine flow)
change from baseline over 52 weeks.
- On August 23, 2013, the Company
announced that it had closed its initial U.S. public offering.
Under the offering, the Company issued 13,000,000 common shares at
a price of $5.00 per share for aggregate gross proceeds of $65
million.
- Upon the closing of the Company’s
initial public offering on The NASDAQ Stock Market, Joseph L.
Turner was formally appointed to the Company’s Board of
Directors. Mr. Turner has more than 25 years of financial
management experience in the biotech and pharmaceutical industries.
Mr. Turner currently serves on the Boards of Directors and is the
chair of the audit committees of three publicly-traded
pharmaceutical companies.
- On August 9, 2013, the Company’s Board
of Directors approved a 52-for-1 share consolidation to increase
the Company’s share price to meet the minimum share price
requirements of The NASDAQ Stock Market.
“During the third quarter Sophiris successfully completed an
initial U.S. public offering and raised the capital necessary to
advance PRX302 into its first Phase 3 clinical trial for a
treatment for enlarged prostate,” stated Randall Woods, President
and CEO of Sophiris Bio. “Our team has quickly mobilized since
completing the offering and already enrolled the first patients
into the first Phase 3 trial of PRX302. Building off of the success
of the previously completed Phase 2 trial, we are focused on steady
execution of the PRX302 Phase 3 clinical program.”
Financial Results for the Third Quarter Ended September 30,
2013
The Company reported a net loss of $3.0 million ($0.31 per
share) for the three months ended September 30, 2013, compared to a
net loss of $5.6 million ($1.79 per share) for the three months
ended September 30, 2012.
Research and development expenses
Research and development expenses were $2.1 million for the
three months ended September 30, 2013 compared to $3.4 million for
the three months ended September 30, 2012. The decrease in research
and development costs is attributable to the following:
- A $0.4 million decrease in costs
associated with the transfer and scale-up of manufacturing
activities for PRX302;
- A $0.2 million decrease in costs
associated with certain non-clinical activities, specifically a
repeat dose monkey study and a rat fertility study both completed
in 2012; and
- A $0.4 million decrease in the costs
associated with the Company’s Phase 1/2 transrectal clinical
trial.
Research and development costs included stock-based compensation
charges of $0.1 million for the three months ended September 30,
2013 which was comparable to the three months ended September 30,
2012.
General and administrative expenses
General and administrative expenses were $0.9 million for
the three months ended September 30, 2013 compared to
$2.0 million for the three months ended September 30, 2012.
This decrease is partially due to a $0.6 million decrease in market
research costs. The remaining decrease is associated with a
reduction in personnel related costs and consulting costs which
were offset partially by an increase in corporate insurance and
stock compensation expense. General and administrative cost
included stock based compensation expense of $0.2 million for
the three months ended September 30, 2013 as compared to
$0.1 million for the three months ended September 30,
2012.
Interest expense
Interest expense, net was $0.3 million for the three months
ended September 30, 2013 compared to $0.4 million in the same
period in 2012. This decrease resulted from a reduction in interest
expense related to the Company’s promissory notes with Oxford
Finance. Interest expense related to Company’s promissory notes
with Oxford Finance is expected to decline over the term of the
loan as the total principal outstanding on the loan is paid
down.
Other income
Other income was $0.4 million for the three months ended
September 30, 2013 as compared to $0.2 million for the three months
ended September 30, 2012. This change was primarily due to a $0.2
million gain recognized for the change in the fair value of the
Company’s warrant liability from the initial recognition date of
the warrant liability, the date of our initial public offering, to
September 30, 2013. As a result of a change in the functional
currency of Sophiris Bio Inc. to the U.S. dollar, the Company was
required to recognize a liability for the fair value of the
Company’s previously issued warrants which were issued with an
exercise price denominated in Canadian dollars. The Company is
required to reassess the fair value of the warrants each reporting
period until the warrants expire or they are exercised. Any
non-cash gain or loss on the fair value of the warrants will be
recorded as a component of other income.
Financial Results for the Nine Months Ended September 30,
2013
The Company reported a net loss of $5.7 million ($1.08 per
share) for the nine months ended September 30, 2013, compared to a
net loss of $15.9 million ($5.25 per share) for the nine months
ended September 30, 2012.
License revenue
During the nine months ended September 30, 2013, the Company
recorded as revenue a $5.0 million non-refundable milestone
payment due from Kissei upon its achievement of certain development
activities, as such milestone had been achieved during this period.
The Company received payment of this milestone in April.
Research and development expenses
Research and development expenses were $6.1 million in the nine
months ended September 30, 2013, compared to $10.2 million in the
nine months ended September 30, 2012. The decrease in research and
development costs is attributable to the following:
- A $1.2 million decrease in the costs
associated with the Company’s non-clinical activities, specifically
a repeat dose monkey study and a rat fertility study both of which
were completed in 2012;
- A $2.3 million decrease in the costs
associated with the transfer and scale-up of manufacturing
activities for PRX302; and
- A $1.3 million decrease in costs
associated with the Company’s Phase 1/2 trial.
Offsetting these decreases is an increase of $0.8 million for
cost associated with the Company’s first Phase 3 clinical trial.
Also offsetting this decrease is a $0.4 million sub-license royalty
fee which was expensed during the nine months ended September 30,
2013 due to UVIC Industry Partnerships and The Johns Hopkins
University associated with the Company’s $5.0 million
milestone payment from Kissei. Research and development expense
included stock-based compensation charges of $0.1 million for both
the nine months ended September 30, 2013 and the nine months ended
September 30, 2012.
General and administrative expenses
General and administrative expenses were $3.0 million in the
nine months ended September 30, 2013, compared to $4.3 million for
the nine months ended September 30, 2012. The decrease of
$1.3 million is partially due to a $0.8 million decrease in
market research costs. The remaining decrease is associated with a
reduction in personnel related costs and consulting costs which
were offset partially by an increase in accounting and tax
professional fees, corporate insurance and stock compensation
expense. General and administrative costs included stock based
compensation expense of $0.6 million for the nine months ended
September 30, 2013 as compared to $0.4 million for the
nine months ended September 30, 2012.
Interest expense
Interest expense was $1.1 million in the nine months ended
September 30, 2013, compared to $1.5 million in the same period in
2012. This decrease resulted from a reduction in interest expense
related to the Company’s promissory notes with Oxford Finance.
Interest expense related to the Company’s promissory notes with
Oxford Finance is expected to decline over the term of the loan as
the total principal outstanding on the loan is paid down.
Other income
Other income was $5,000 for the nine months ended September 30,
2013, compared to $0.1 million for the nine months ended September
30, 2012. Included as a component of other income during the nine
months ended September 30, 2013 was a $0.2 million gain associated
with the change in the fair value of the Company’s warrant
liability. This gain was offset almost entirely by foreign currency
exchange losses.
Income tax expense
The milestone payment from Kissei was subject to a ten percent
Japanese withholding tax. As a result the Company recorded an
income tax expense of $0.5 million for the nine months ended
September 30, 2013. The Company will be eligible to utilize the
withholding tax to offset future taxes due in Japan, if any. Given
the uncertainty around the Company’s ability to generate future
taxable income, the Company has expensed the withholding tax during
the nine months ended September 30, 2013.
For complete financial results, please see the Company’s website
at www.sophiris.com.
About Sophiris
Sophiris Bio Inc. is a biopharmaceutical company developing a
clinical-stage, targeted treatment for the symptoms of benign
prostatic hyperplasia (BPH or enlarged prostate), which it believes
is an unsatisfied market with significant market potential.
Sophiris’ lead candidate for BPH, PRX302, 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 initiated its first Phase 3 clinical
trial of PRX302 in October 2013. For more information, please visit
www.sophiris.com.
Certain statements included in this press release may be
considered forward-looking, including the quote of our President
and CEO and any expectations relating to our Phase 3 trial of
PRX302 or our capital requirements. 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, clinical trial
enrollment and results,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 Balance
Sheets
(in thousands, except share amounts)
(unaudited)
September 30,2013 December
31,2012 Assets Current assets: Cash and
cash equivalents $ 54,739 $ 9,721 Other receivables 30 71 Deferred
financing costs — 937 Prepaid expenses 3,212 593
Total current assets 57,981 11,322 Property and
equipment, net 102 163 Other long-term assets 19 44
Total assets $ 58,102 $ 11,529
Liabilities and stockholders’ equity Current liabilities:
Accounts payable $ 1,600 $ 1,774 Accrued expenses 1,233 2,839
Current portion of promissory notes 6,724 5,895 Total
current liabilities 9,557 10,508 Long-term promissory notes,
less current portion 1,693 6,126 Warrant liability 1,376 —
Total liabilities 12,626 16,634
Commitments and contingencies
Stockholders’ equity
(deficit): Common stock, unlimited authorized shares, no par
value; 16,149,871 and 3,149,871 shares issued and outstanding at
September 30, 2013 and December 31, 2012, respectively 111,218
54,215 Common share purchase warrants — 6,045 Contributed surplus
13,567 8,379 Accumulated other comprehensive (loss) gain 99 (46 )
Deficit accumulated during development stage (79,408 ) (73,698 )
Total stockholders’ equity (deficit) 45,476 (5,105 )
Total liabilities and stockholders’ equity (deficit) $
58,102 $ 11,529
Sophiris Bio Inc.
Condensed Consolidated Statement of
Operations and Comprehensive Loss
(in thousands, expect share and per share
amounts)
(unaudited)
Three Months Ended
September 30,
Nine Months Ended
September 30,
Cumulative period from January
11, 2002 (date of inception) to September
30, 2013
2013 2012 2013
2012 Revenues: License revenue $
— $ — $ 5,000 $ — $ 8,000
Operating expenses:
Research and development 2,117 3,411 6,143 10,193 55,788 General
and administrative 883 1,980 3,009 4,342
27,487 Total operating expenses 3,000 5,391
9,152 14,535 83,275
Other
income (expense): Interest income (expense), net (313 ) (445 )
(1,064 ) (1,450 ) (2,977 ) Other income (expense), net 361
206 5 122 (341 ) Total other income (expense)
48 (239 ) (1,059 ) (1,328 ) (3,318 )
Net loss
before income taxes (2,952 ) (5,630 ) (5,211 ) (15,863 )
(78,593 ) Income tax expense — — (500 ) —
(815 )
Net loss $ (2,952 ) $ (5,630 ) $ (5,711
) $ (15,863 ) $ (79,408 )
Basic and diluted loss per
share
$
(0.31 )
$
(1.79 ) $ (1.08 ) $ (5.25 ) Weighted average number of outstanding
shares – basic and diluted 9,509 3,150 5,293
3,021
Other comprehensive income (loss) Currency
translation adjustment (154 ) 211 146 108 99
Total comprehensive loss $ (3,106 ) $ (5,419 ) $
(5,565 ) $ (15,755 ) $ (79,309 )
Sophiris Bio Inc.
Condensed Consolidated Statement of
Cash Flows
(in thousands)
(unaudited)
Nine Months Ended
September 30,
Cumulative Period From January
11, 2002 (date of inception) toSeptember 30,
2013
2013 2012 Cash flows used in
operating activities Net loss for the period $ (5,711 ) $
(15,863 ) $ (79,408 ) Adjustments to reconcile net loss to net cash
used by operating activities: Stock-based compensation 715 488
5,052 Accretion of debt discount 299 391 1,029 Depreciation of
property and equipment 63 61 586 Amortization of intangible assets
— 149 1,205 Amortization of promissory note issuance costs 86 119
310 Impairment loss — 176 176 Change in fair value warrant
liability (195 ) — (195 ) Foreign exchange (gain) loss 216 (109 )
(1,453 ) Loss on disposal of assets — — 25 Other — — 182 Changes in
operating assets and liabilities: Other receivables 36 142 21
Prepaid expenses (2,680 ) 81 (3,483 ) Deferred financing costs — —
(936 ) Other long-term assets 6 (15 ) (38 ) Accounts payable and
accrued expenses (1,657 ) (637
)
2,675 Net cash used in operating activities (8,822 ) (15,017
) (74,252 )
Cash flows used in investing activities
Purchases of property and equipment (3 ) (26 ) (725 ) Proceeds from
the disposal of property and equipment — — 11 Acquisition of
intangible assets — — (1,372 ) Maturity of marketable securities —
— 1,112 Purchases of marketable securities — — (1,112
) Net cash flows used in investing activities (3 ) (26 ) (2,086 )
Cash flows from financing activities Issuance of
common shares from private placement, net of issuance cost — 8,285
50,179 Issuance of common shares from public offering, net of
issuance cost 57,816 — 60,844 Issuance of preferred shares, net of
issuance cost — — 465 Cash acquired on reverse acquisition — — 818
Issuance of common shares on exercise of warrants — — 8,702
Issuance of common shares on exercise of stock options — — 514 Cash
received from the issuance of promissory notes — — 15,000 Principal
payments on notes payable (3,903 ) (1,801 ) (7,092 ) Increase in
lease obligations — — 120 Capital lease payments — — (120 )
Deferred financing costs — — — Other — — 4 Net
cash provided by financing activities 53,913 6,484
129,433 Effect of exchange rate changes on cash and cash
equivalents (70 ) 375 1,644
Net increase
(decrease) in cash and cash equivalents 45,018 (8,184 ) 54,739
Cash and cash equivalents at beginning of period 9,721
23,410 —
Cash and cash equivalents at end
of period $ 54,739 $ 15,226 $ 54,739
Company Contact:Sophiris Bio Inc.Peter Slover, Chief
Financial Officer858-777-1760orCorporate Communications and
Investor Relations:Canale CommunicationsJason Spark,
619-849-6005jason@canalecomm.comorEquicom GroupMichael Moore,
619-467-7067mmoore@tmxequicom.com
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