Akela Pharma Inc
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Akela Pharma repeating Fentanyl inhalant safety study at FDA request
www.canadianbusiness.com | Jul 8, 2008
MONTREAL - Akela Pharma Inc. (TSX:AKL) has started over again with safety studies on its Tamifun pla
http://www.canadianbusiness.com/markets/headline_news/article.jsp?content=b070829A
Akela Pharma Awarded Development Contract from Pear Tree Pharmaceuticals, Inc. at its PharmaForm Subsidiary
www.bioportfolio.co.uk | Jun 15, 2008
Biotechnology and Pharmaceutical Industry Search Find Companies, News, Events, Jobs, Directory
Akela Pharma Inc. Initiates Its First Abuse Deterrent Opioid Phase I Clinical Trial
www.biospace.com | Mar 6, 2008
MONTREAL, March 6 /PRNewswire-FirstCall/ - Akela Pharma Inc. (TSX: "AKL"), a drug development company focused on developing therapies for the inhalation and pain markets, today announced that it has started its first EDACS(TM) product Phase I clinical trial.
http://www.biospace.com/news_story.aspx?StoryID=88375&full=1
Akela Pharma initiates its first abuse deterrent opioid Phase I clinical trial
www.prnewswire.com | Mar 6, 2008
The study will be carried out in 12 healthy subjects, and the results are expected to be available in Q3/2008. "The abuse of prescription drugs is approaching epidemic proportions in numerous countries. The costs to society associated with this abuse are tremendous.
http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=109&STORY=/www/story/03-06-2008/0004768856&EDATE=
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Akela - Company Overview - Hoover's
The industry is marked by rapid advances in scientific knowledge that produce ever-more effective medicines. Profitability is determined mainly by the ability to discover new drugs....
http://www.hoovers.com/akela/--ID__117179--/free-co-factsheet.xhtml
Agenda: Day 1 - Monday, December 3, 2007 - Search Engine Strategies Chicago - December 3-7, 2007
Search Around the World - Part One: Asia/Pacific & Australia Eastern and Western companies are rushing to get a piece of the action internationally, but does anyone really understand the marketplace? In this session, attendees will learn how to separate hype from actionable activity.
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News from Zibb.com
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Akela Pharma reports results for the second quarter of fiscal 2008 - Zibb.com
MONTREAL, Aug. 14, 2008 (Canada NewsWire via COMTEX) --
www.akelapharma.com
Toronto Stock Exchange Symbol: AKL
Akela Pharma Inc. (TSX: AKL), a drug development company focused on developing therapies for the inhalation and pain markets, today announced its financial results for the three and six months ended June 30, 2008.
Consolidated revenues for the second quarter and six months ended June 30, 2008 were $3.2 million and $7.1 million, respectively. For the three and six months ended June 30, 2008, Akela's consolidated net loss was $4.2 million and $8.7 million.
During the second quarter of 2008, we had a number of operational achievements which position us well for accelerated growth through the close of the year. In May our original licensing and development agreement with Janssen Pharmaceutica NV for Fentanyl TAIFUN(R) was amended to secure advanced milestones of $3,9 million (2,5 million euros) on the first local regulatory approval of the Phase III protocol and $3,1 million (2,0 million euros) on clinical site readiness. Under the licensing agreement an additional milestone of $3,9 million (2,5 million euros) will be due as of the inclusion of the 7th patient in the study. We expect all events to occur during the next four to five months. During the second quarter our PharmaForm subsidiary was awarded with several new drug formulation and manufacturing contracts with an estimated revenue potential in excess of $5,0 million. On July 28, 2008 PharmaForm entered into a lease agreement for a 69,872 square foot facility located in Austin, Texas. This state of the art facility will allow us to accommodate the growing demand for our current service offering and expand into commercial scale manufacturing.
2008 Second Quarter Financial Highlights
<<
- Total consolidated revenues for the second quarter of 2008 were
$3.2 million, including $0.5 million in co-development fees and
$2.7 million of contract services. Total consolidated revenues for the
first quarter of 2007 were $3.4 million, including $0.4 million in
co-development fees and $2.6 million of contract services.
- Consolidated net loss for the second quarter of 2008 was $4.2 million
or ($0.19) per share. Consolidated net loss for the second quarter of
2007 was $8.6 million or ($0.50) per share.
2008 Second Quarter Operational Highlights
- On May 14, 2008, the Company announced that it had won the "Best
Abstract Reward" at the recent 11th Asia Pacific Congress of Nephrology
in Kuala Lumpur, Malaysia in the "International Abstract" category for
its GHRH Phase II results abstract.
- On May 23, 2008, the Company's original licensing and development
agreement with Janssen Pharmaceutica NV for Fentanyl TAIFUN(R) was
amended to secure advanced milestones of $3,900 (2,500 euros) on the
first local regulatory approval of the Phase III protocol and $3,100
(2,000 euros) on clinical site readiness. Under the licensing
agreement an additional milestone of $3,900 (2,500 euros) will be due
as of the inclusion of the 7th patient in the study.
- On July 28, 2008, the Company's PharmaForm subsidiary signed an office
lease agreement with HEP-Davis Spring, L.P. Pursuant to the lease,
PharmaForm will relocate operations from its current 50,000 square foot
facility to approximately 69,872 square feet of space in a building
located at 9825 Spectrum Drive, Austin, Texas for a term of 15 years,
commencing on or after November 1, 2008. The Company estimates that
PharmaForm's gross base rental obligation over the term of the Lease
will be approximately $15.8 million.
Financial Results
Consolidated SG&A expenses totalled $1.7 million for the second quarter of
2008 compared to $4.1 million for the second quarter of 2007.
R&D costs for the second quarter of 2008 were $2.9 million compared to
$4.6 million for the second quarter of 2007. The decrease in spending is
primarily attributable to the downsizing of our Finnish operation and lower
Fentanyl TAIFUN(R) related clinical trial spending.
The consolidated net loss for the second quarter of 2008 was $4.2 million,
or ($0.19) per share compared with a net loss of $8.6 million or ($0.50) per
share for the second quarter of 2007.
The Company had a cash balance of $7.6 million as of June 30, 2008
compared with $6.7 million as of December 31, 2007.
About Akela Pharma Inc.
Akela Pharma is an integrated drug development company focused on
developing therapies for the growing multi-billion dollar inhalation and pain
markets. Its lead product, for the treatment of breakthrough cancer pain, is a
fast-acting Fentanyl formulation delivered using the Company's TAIFUN(R) dry
powder inhaler platform. Its pipeline also includes therapeutics for asthma,
COPD, growth hormone deficiencies and controlled substance abuse deterrent
formulations.
Akela's common shares trade on The Toronto Stock Exchange ("TSX") under
the symbol "AKL" with 21.6 million shares outstanding.
This news release contains certain forward-looking statements that reflect
the current views and/or expectations of Akela Pharma Inc. with respect to its
performance, business and future events. Such statements are subject to a
number of risks, uncertainties and assumptions. Actual results and events may
vary significantly.
AKELA PHARMA INC.
Consolidated Balance Sheets
(Unaudited)
Periods ended June 30, 2008 and 2007
(in thousands of US dollars)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
June 30, December 31,
2008 2007
-------------------------------------------------------------------------
Assets
Current assets:
Cash $ 7,569 $ 6,688
Accounts receivable 1,621 4,806
Prepaid expenses 287 462
-----------------------------------------------------------------------
9,477 11,956
Restricted cash 600 600
Property and equipment 4,992 5,220
Intangible assets 12,864 14,170
Goodwill 6,457 6,457
Other assets 2,292 738
-------------------------------------------------------------------------
$ 36,682 $ 39,141
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable and accrued liabilities $ 6,483 $ 8,873
Deferred revenue 2,453 2,598
Current portion of long-term debt 495 499
-----------------------------------------------------------------------
9,431 11,970
Deferred revenue 9,211 10,145
Long-term debt 6,121 5,824
Future income taxes 1,150 1,154
Shareholders' equity:
Common shares (unlimited authorized,
21,615,577 and 11,768,294 common shares
issued and outstanding with no par
value at June 30, 2008 and
December 31, 2007) 66,346 54,227
Preference shares (issuable in series,
unlimited authorized, zero issued
and outstanding) - -
Warrants 2,814 364
Additional paid-in capital 7,909 11,702
Accumulated other comprehensive income 3,110 3,110
Deficit (69,410) (59,355)
-----------------------------------------------------------------------
(66,300) (56,245)
Total shareholders' equity 10,769 10,048
Commitments, contingencies and guarantees
-------------------------------------------------------------------------
$ 36,682 $ 39,141
-------------------------------------------------------------------------
-------------------------------------------------------------------------
See accompanying notes to unaudited consolidated financial statements.
AKELA PHARMA INC.
Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
Periods ended June 30, 2008 and 2007
(in thousands of US dollars, except share and per share data)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Three months ended Six months ended
June 30, June 30,
-------------------------------------------------------
2008 2007 2008 2007
-------------------------------------------------------------------------
Revenues $ 3,222 $ 3,409 $ 7,092 $ 4,783
Expenses:
Direct costs 1,750 1,448 3,438 2,241
Selling,
general and
administrative 1,713 4,102 3,806 6,538
Research and
development 2,882 4,595 5,454 9,638
Stock-based
compensation 111 379 281 497
Depreciation
of property
and equipment 445 245 908 409
Amortization
of intangible
assets 680 700 1,424 1,234
Interest on
long-term debt 40 50 71 97
Foreign
exchange (181) (1,127) 350 (714)
-----------------------------------------------------------------------
7,440 10,392 15,732 19,940
Net loss before
income taxes (4,218) (6,983) (8,640) (15,157)
Recovery of
(provision for)
income taxes:
Current - (119) - (138)
Future 47 (6) 93 80
-----------------------------------------------------------------------
47 (125) 93 (58)
-------------------------------------------------------------------------
Net loss and
comprehensive
loss $ (4,171) $ (7,108) $ (8,547) $ (15,215)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Basic and
diluted net
loss per share $ (0.19) $ (0.60) $ (0.50) $ (1.30)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Basic and diluted
weighted average
number of shares
outstanding 21,615,577 11,762,938 16,938,309 11,674,506
-------------------------------------------------------------------------
-------------------------------------------------------------------------
See accompanying notes to unaudited consolidated financial statements.
AKELA PHARMA INC.
Consolidated Statement of Shareholders' Equity
(Unaudited)
Six month period ended June 30, 2008
(in thousands of US dollars)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Common Shares
-------------------------
Number Dollars
-------------------------------------------------------------------------
Balance, December 31, 2007 11 768 294 $ 54 227
Issuance of units 8 625 000 8 045
PharmaForm acquisition -
Phase II Share Payment 1 222 283 4 074
Stock-based compensation - -
Net loss - -
-------------------------------------------------------------------------
Balance, June 30, 2008 21 615 577 $ 66 346
-------------------------------------------------------------------------
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Accumu-
lated
other
Additional compre-
Paid-in hensive
Warrants Capital income Deficit Total
-------------------------------------------------------------------------
Balance, December
31, 2007 $ 364 $ 11 702 $ 3 110 $ (59 355) $ 10 048
Issuance of units 2 450 - - (1 508) 8 987
PharmaForm
acquisition -
Phase II Share
Payment - (4 074) - - -
Stock-based
compensation - 281 - - 281
Net loss - - - (8 547) (8 547)
-------------------------------------------------------------------------
Balance,
June 30, 2008 $ 2 814 $ 7 909 $ 3 110 $ (69 410) $ 10 769
-------------------------------------------------------------------------
-------------------------------------------------------------------------
See accompanying notes to unaudited consolidated financial statements.
AKELA PHARMA INC.
Consolidated Statements of Cash Flows
(Unaudited)
Periods ended June 30, 2008 and 2007
(in thousands of US dollars)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Three months ended Six months ended
June 30, June 30,
2008 2007 2008 2007
-------------------------------------------------------------------------
Cash flows
from operating
activities:
Net loss $ (4 171) $ (7 108) $ (8 547) $ (15 215)
Adjustments for:
Depreciation
of property
and equipment 445 245 908 409
Amortization
of intangible
assets 680 700 1 424 1 234
Stock-based
compensation 111 379 281 497
Unrealized
foreign
exchange
(gain) loss (250) - 264 -
Services
rendered for
shares - - - 52
Future income
taxes (47) 6 (93) (80)
Net changes
in operating
assets and
liabilities 95 (28) 90 (1 268)
-------------------------------------------------------------------------
(3 137) (5 806) (5 673) (14 371)
Cash flows from
financing
activities:
Restricted cash - (600) - (600)
Repayments of
long-term debt (107) (1 242) (326) (1 860)
Proceeds from
issuance of
long-term debt - 1 200 - 1 200
Proceeds from
issuance of
units - - 10 200 -
Unit issue costs (163) - (1 213) -
-------------------------------------------------------------------------
(270) (642) 8 661 (1 260)
Cash flows from
investing
activities:
Acquisition of
PharmaForm, net
of cash - (55) - (8 180)
Acquisition of
property and
equipment (1 453) (618) (1 984) (869)
Addition to
intangible
assets (168) - (189) -
-------------------------------------------------------------------------
(1 621) (673) (2 173) (9 049)
Net increase
(decrease) in
cash (5 028) (7 121) 815 (24 680)
Cash, beginning
of period 12 837 19 658 6 688 35 304
Effect of
exchange rate
changes (240) (417) 66 1 496
-------------------------------------------------------------------------
Cash, end of
period $ 7 569 $ 12 120 $ 7 569 $ 12 120
-------------------------------------------------------------------------
-------------------------------------------------------------------------
See accompanying notes to unaudited consolidated financial statements.
>>
%SEDAR: 00003466E
SOURCE: Akela Pharma Inc.
Frédéric Dumais, Vice-President, Investor Relations, (514) 315-3330 ext. 106, Fax: (514) 315-3325 or visit Akela's website at www.akelapharma.com
Tags: acquisition asia asthma business cancer clinical commercial contract debt deficit dollar equity financial results foreign exchange local malaysia manufacturing pipeline property research and development revenue state of the art taxes texas toronto trade trial
Companies: Akela Pharma Inc (AKL)
Akela Pharma awarded development contract at its PharmaForm subsidiary - Zibb.com
MONTREAL, Jul 24, 2008 (Canada NewsWire via COMTEX) --
www.akelapharma.com
Toronto Stock Exchange Symbol: AKL
Akela Pharma Inc. (TSX: "AKL"), a drug development company focused on developing therapies for the inhalation and pain markets, today announced that it has been awarded a contract at its PharmaForm subsidiary located in Austin, Texas, to process validate and manufacture Phase III Registration Batches for Proellex(R), a drug product developed by Repros Therapeutics, Inc (NASDAQ: "RPRX").
"We are very pleased to have been awarded this important contract and with our long relationship with Repros. Proellex(R) will fill unmet medical needs and could be a blockbuster should it meet all clinical endpoints. It represents a great partnership and opportunity for both organizations." said Dr. Michael Crowley, Vice President, Business Development of PharmaForm.
About Repros:
Repros Therapeutics focuses on the development of oral small molecule drugs for major unmet medical needs that treat male and female reproductive disorders.
For more information, please visit the Company's website at http://www.reprosrx.com.
About Akela Pharma Inc.:
Akela Pharma is an integrated drug development company focused on developing therapies for the growing multi-billion dollar inhalation and pain markets. Its lead product, for the treatment of breakthrough cancer pain, is a fast-acting Fentanyl formulation delivered using the Company's TAIFUN(R) dry powder inhaler platform. Its pipeline also includes therapeutics for asthma, COPD, growth hormone deficiencies and controlled substance abuse deterrent formulations. PharmaForm, Akela's wholly owned subsidiary, is a leading specialty contract service provider offering a portfolio of innovative technologies in drug product development, manufacturing and analytical testing to the pharmaceutical and biotechnology industries. Through its diverse offerings, PharmaForm solutions help clients reduce development costs and accelerate time-to-market.
Akela's common shares trade on The Toronto Stock Exchange ("TSX") under the symbol "AKL" with 21.6 million shares outstanding.
This news release contains certain forward-looking statements that reflect the current views and/or expectations of Akela Pharma Inc. with respect to its performance, business and future events. Such statements are subject to a number of risks, uncertainties and assumptions. Actual results and events may vary significantly.
%SEDAR: 00003466EF
SOURCE: Akela Pharma Inc.
visit www.akelapharma.com or contact: Frédéric Dumais, Vice-President, Investor Relations, (514) 315-3330 ext. 106, Fax: (514) 315-3325
Tags: asthma biotechnology business cancer contract dollar drugs manufacturer manufacturing medical nasdaq partnership pipeline president product development technology texas toronto trade
Companies: Akela Pharma Inc (AKL)
LAB Research Announces its 2008 Second Quarter Financial Results - Zibb.com
LAVAL, QC, Jul 31, 2008 (Canada NewsWire via COMTEX) --
Record revenues of $16.1 million and strong backlog
LAB Research Inc. (TSX: LRI) ("LAB Research" or the "Company"), a Canadian-based global non-clinical contract research organization, today announced its 2008 second quarter financial results. This press release contains forward-looking information, investors are invited to read the cautionary language contained under "Forward-Looking Statements" below.
<<
Highlights
Three months ended June 30, 2008 and 2007:
- Revenues of $16.1 million, up 9% with strong performance from Canada
and Denmark where combined revenues increased by 19% offset by a
decrease in Hungary;
- Adjusted EBITDA of $3.0 million, down 12% (up 15% compared to Q1 2008);
- Net earnings of $0.7 million ($0.04 per share), down 54% (up 37%
compared with Q1 2008);
- Backlog of $28.8 million, up 31%;
- Backlog in Hungary up 25%, compared to Q1 2008, representing 1.8:1 book
to bill ratio
Six months ended June 30, 2008 and 2007:
- Revenues of $31.5 million, up 14%;
- Adjusted EBITDA of $5.5 million down 10%;
- Net earnings of $1.3 million ($0.07 per share), down 55%;
- Backlog up 7% (335% in Hungary representing a book to bill ratio of
2.27:1).
"In the second quarter of 2008, our Canadian and Danish sites continued to
yield excellent performance and profit growth. Their combined revenues
increased by 19% compared to the results achieved in the second quarter of
2007, while their combined adjusted EBITDA increased by 11%. The Company's
overall financial performance was still affected by our Hungarian site, which
recorded sales of $1.3 million in the second quarter of the current fiscal
year due to slow study starts. As mentioned in our Q1 press release, the
situation in Hungary is improving as evidenced by our strong contract signing.
In fact, the backlog went from $1.4 million in December 2007, to $3.9 million
in March 2008, and to $4.8 million in June 2008, an increase of more than 300%
in six months. This backlog should convert into higher revenues and better
financial performance in the second half of 2008 as more revenues from signed
contracts start being recognized," said Luc Mainville, President and Chief
Executive Officer of LAB Research.
Financial Results for the Quarter Ended June 30, 2008
LAB Research posted record revenues of $16.1 million in the second quarter
of 2008, up 9% compared to $14.7 million in the second quarter of 2007. While
LAB Canada and LAB Denmark's combined revenues increased by 19%, the revenues
of the Hungarian site declined by 44%.
Our Canadian non-clinical operations ("LAB Canada") posted record revenues
of $7.0 million in the second quarter of 2008, up 10% compared to $6.4 million
during the same period of 2007, and up 13% compared to $6.2 million in the
first quarter of 2008. These increases are attributable to increased
utilization of capacity following the December 2006 expansion and a good study
mix.
Our Danish subsidiary ("LAB Denmark") posted revenues of $7.8 million in
the second quarter of 2008, up 28% compared to $6.1 million in the second
quarter of 2007. This increase is attributable to an increased utilization of
capacity, expanded by 25% in July 2007.
Our Hungarian subsidiary ("LAB Hungary") posted revenues of $1.3 million
in the second quarter of 2008, down 44% compared to $2.3 million generated in
the same period of 2007. This significant decrease is due to slower than
anticipated study starts and a less than optimal study mix composed of a high
percentage of studies from the agro-chemical market in 2008. These studies
provide less revenues and lower margins than the more lucrative pharma and
biotech markets. Nevertheless, the backlog has increased more than three fold
since December 2007, from $1.4 million to $4.8 million as at June 30, 2008
representing a book-to-bill ratio of 2.27:1 for that six-month period. While
we are pleased by the increase in backlog in Hungary, we have experienced a
high level of delays in the initiation of many lucrative contracts which we
anticipated would have contributed to a more rapid recovery of our revenues in
Hungary. Nevertheless, we are benefiting from incremental contract signing
which we expect should provide better revenues in Hungary for the balance of
2008.
Overall, the Company's gross margin was 33% in the second quarter of 2008,
compared with 39% in the second quarter of 2007 (33% in the first quarter of
2008). While Canadian gross margin held steady, gross margin for Danish
activities decreased by 10% and went from 43% to (14%) in Hungary. The
negative variances are explained in Denmark, by higher salary costs and less
than optimal study mix, and in Hungary by lower than anticipated revenues. For
the second quarters of 2008 and 2007, earnings before interest, income taxes,
depreciation and amortization ("EBITDA") stood at $3.0 million (adjusted
EBITDA of $3.0 million considering the impact of the Canadian facility's
sale-leaseback transaction) and $3.3 million (adjusted EBITDA $3.4 million),
respectively.
The Company's 2007 repurchase of the Canadian site and improvement at the
Danish and Hungarian sites increased amortization and interest expenses. In
fact, amortization expense was $1.3 million, compared with $1.0 million in the
second quarter of 2007, and net interest expense was $0.6 million, compared
with $0.3 million in the second quarter of 2007.
As a result, net earnings were $0.7 million, compared with $1.6 million
for the same period of 2007. Note that Canadian and Danish operations
generated net combined earnings of $1.7 million, while Hungarian operations
recorded a net loss of $0.4 million. Earnings per share were $0.04 per share
($0.04 per share on a diluted basis) on the basis of 18,062,526 weighted
average shares outstanding (basic), compared with earnings per share of $0.09
($0.09 per share on a diluted basis) for the same period in 2007 on the basis
of 18,035,714 shares.
Financial Results for the Half-Year Ended June 30, 2008
LAB Research posted revenues of $31.5 million in the first six months of
2008, up 14% compared to $27.7 million during the same period of 2007. While
LAB Canada and LAB Denmark's combined revenues increased by 26%, Hungarian
revenues declined by 45%. LAB Canada posted revenues of $13.2 million, up
27% compared to $10.4 million in the first half of 2007. LAB Denmark posted
revenues of $15.7 million, up 26% compared to $12.5 million during the same
period of 2007. Finally, LAB Hungary posted revenues of $2.7 million, down
45%, compared to $4.9 million in the first half of 2007.
Gross margin was 33%, compared to 39% for the same period in 2007.
Adjusted EBITDA totalled $5.5 million, compared to $6.2 million, representing
adjusted EBITDA margins of 18% and 22%, respectively.
The Company's net earnings totalled $1.3 million, compared to $2.9 million
for the same period in 2007. During the first six months of 2008, Canadian and
Danish operations generated net combined earnings of $3.3 million, compared to
$2.8 million in the first half of 2007. This strong performance was offset by
a reduced performance of our Hungarian site. Earnings per share were $0.07
($0.07 per share on a diluted basis) on the basis of 18,056,615 weighted
average shares outstanding (basic), compared with earnings per share of $0.16
($0.15 per share on a diluted basis) for the same period in 2007 on the basis
of 18,035,714 shares.
Canadian Site Expansion
In the second half of 2007, the Company initiated a major expansion of its
Canadian site. Significant progress was achieved in the first six months of
2008, and completion is still expected early in the fourth quarter of 2008
with some capacity added by the end of the third quarter. This expansion will
increase the facility from 87,000 to 170,000 square feet and its animal
housing capacity from 36 to 80 rooms. Once completed and fully equipped, the
expanded site capacity should increase three-fold. As announced on May 6,
2008, the Company secured bank financing in the amount of $21.1 million. The
loan consists of a $13.7 million mortgage with a 16-year term and a
$7.4 million loan to finance equipment, repayable over 11 years. As at
June 30, 2008, the projected $24 million expansion budget had been committed
as well as $1 million of the 2009 planned expenditures which have been
accelerated to initiate Absorption, Distribution, Metabolism, Excretion
("ADME") services more rapidly. As we are approaching the commissioning of the
building, we are foreseeing completion ahead of the original schedule and
within budget.
Follow-up on the Litigation by a Sponsor
On January 30, 2008, the Company was informed by one of its sponsors that
it had received notice from the Food and Drug Administration ("FDA") that the
animal inhalation toxicology studies conducted by LAB Hungary were rejected
due to Good Laboratory Practices ("GLP") deficiencies. In their letter to the
sponsor, the FDA had highlighted deficiencies already mentioned and addressed
by LAB Hungary in its final GLP report of the respective studies to the
sponsor. Following issuing of the reports by LAB Hungary, each of the Company,
the sponsor and its third party expert concluded that these deficiencies did
not alter the results of the studies. Consequently, the sponsor filed its
Investigational New Drug filing with the FDA in September 2007. On June 3,
2008, LAB Research received a revised demand letter from the sponsor seeking
recovery of some study costs in the amount of 2.7 million Euros
($4.4 million), payment of the costs to repeat the studies evaluated at
US$5 million ($5.1 million), and damages in the amount of US$20 million
($20.4 million) representing the licensing fees the sponsor claimed it would
have received from a potential partner.
The sponsor also reaffirmed its intention to seek damages from the Company
associated with the reduced market capitalization and loss of rights under the
sponsor's existing licensee, which the sponsor admittedly could not calculate.
Following an investigation and a review of the claim received from the
sponsor, the Company's insurer has indicated to LAB Research that the loss
would appear to be covered by the Company's insurance policy up to its
coverage level subject to review of a prospective breakdown of damages or
legal action, if taken by the sponsor. Under the contract signed between the
sponsor and the Company concurrently with the Initial Public Offering of
August 3, 2006, the Company cannot be held liable for any incidental, indirect
or consequential damages of the sponsor and LAB Research's liability is
limited to the amount received for such study work and, even in the case of
gross negligence, cannot exceed two times the amount received for the study,
an amount far less than the figures now being claimed.
LAB Research continues to believe that most GLP deficiencies were directly
the result of the study protocol dictated by the sponsor. The sponsor is
seeking full reimbursement of the study costs which assumes that the studies
would have met regulatory requirements and that the study findings would have
provided no benefits to the sponsor in reaching this goal. Since the FDA
notice, the sponsor has publicly confirmed that the toxicology studies had
been re-initiated, and that the protocols had been modified to take into
account findings of the studies performed by LAB Hungary.
We intend to vigorously contest any future legal action taken by the
sponsor. The ultimate resolution of this matter and the estimated damages, if
any, cannot be determined and, accordingly, the Company has not recorded any
provision in its financial statements for this matter.
On December 21, 2007, LAB Research was served with an introductory motion
of suit from one of its former suppliers claiming an amount of $1.4 million
for the breach of a right of first refusal. On May 7, 2008, LAB Research
served its defence denying liability for the principal claim and filed its own
cross-claim for damages caused by same supplier during the construction of the
previous phase of building expansion in Canada. The ultimate resolution of
this matter and the estimated damages, if any, cannot be determined and,
accordingly, the Company has not recorded any provision in its financial
statements for this matter.
LAB Research is party to other litigation arising in the normal course of
operations. LAB Research does not expect the resolution of these other matters
to have a materially adverse effect on the financial position of results of
operations of the Company.
Towards a Strong Ending of 2008
Achieving critical mass and maximizing capacity utilization are two of LAB
Research's main objectives. These key success factors allow for increased
scheduling flexibility and internalization of additional services, leading to
higher profit margins. Since December 2006, LAB Research added 106,000 square
feet to its overall surface area, numerous services, and more than 100
high-calibre employees. The site's average surface area is now 115,000 square
feet (51 animal rooms), compared to an estimated average of 286,000 square
feet (131 animal rooms) for the world's five largest non-clinical Contract
Research Organizations. Following the completion of LAB Research's Canadian
expansion in the fourth quarter of the current fiscal year, its total surface
area will be 427,000 square feet, for an average of 142,000 square feet per
site and 66 animal rooms, representing a 94% increase in square footage and
77% increase in animal rooms since the 2006 Initial Public Offering.
"Our Canadian and Danish sites have done very well at maximizing their
capacity utilization following recent expansions. As for our Hungarian site,
the expansion of which was completed in the third quarter of 2007, capacity
utilization remains our main objective. Through the efforts of the new
management and all employees, the backlog has increased considerably since the
beginning of the year, and this will translate into increased revenues and
gross margin in the coming quarters. All in all, we are still confident that
our 2008 growth rate will exceed the industry's projected 15% growth, and that
the Company's profitability will return to its historical levels," added
Mr. Mainville. "The ongoing litigation with our former parent company impacted
our ability to quickly recover from a difficult year, last year, in Hungary.
Nevertheless we remain very optimistic about the ability of the site to reach
profitability in the coming quarters based on our growing backlog. Based on
progress made to date, we are convinced that LAB Hungary has the required
ingredients to be successful." added Mr. Mainville.
Forward-Looking Statements
Certain statements in this document are forward looking and prospective.
By their nature, forward-looking statements require us to make assumptions and
are subject to inherent risks and uncertainties. There is significant risk
that predictions and other forward-looking statements will not prove to be
accurate. Readers of this document are cautioned not to place undue reliance
on our forward-looking statements as a number of factors could cause future
results, conditions, actions, or events to differ materially from the
operating target, expectations, estimates, or intentions expressed in the
forward-looking statements. For additional information on these and other
factors, see the reports filed by LAB Research with Canadian securities
regulators.
Forward-looking statements reflect our current views with respect to
future events and are based upon what we believe are reasonable assumptions
and subject to risks and uncertainties. These forward-looking statements
represent our estimates and assumptions only as at the date of this document.
We undertake no obligation and do not intend to update or revise these
forward-looking statements, unless required by law.
About LAB Research Inc.
LAB Research is a Canadian global non-clinical contract research
organization that provides contract research services to the pharmaceutical,
biotechnology, agro-chemical, petro-chemical, and industrial markets. LAB
Research supports the development of its clients' products from three
state-of-the-art facilities located in Canada, Denmark, and Hungary. LAB
Research shares trade on the TSX under the symbol "LRI," with 18.1 million
shares outstanding.
Appendix 1: Non Generally Accepted Accounting Principles ("GAAP")
Measures
We use certain non-GAAP measures, including Book to Bill ratio, Backlog,
EBITDA, Adjusted EBITDA, Adjusted EBITDA Margin, and Gross Margin, as
financial performance indicators. The Company believes such measures provide
meaningful information on its performance and operating results. However,
readers are cautioned that non-GAAP measures do not have a standardized
meaning under GAAP and, thus, they are unlikely to be comparable to similar
measures presented by other issuers.
(a) EBITDA
The following table reconciles our net earnings to our EBITDA and our
Adjusted EBITDA, from continuing activities by reporting periods.
Three months Six months
ended ended
June 30 June 30
2008 2007 2008 2007
-------- -------- -------- --------
(in thousands of dollars) $ $ $ $
Net earnings from
continuing activities 748 1,615 1,295 2,871
Adjustements for:
Income taxes 332 304 547 668
Interest on long-term
debt 573 376 1,153 487
Amortization 1,303 968 2,538 1,793
-------- -------- -------- --------
EBITDA 2,956 3,263 5,533 5,819
Rent Expense(1) - 102 - 363
-------- -------- -------- --------
Adjusted EBITDA 2,956 3,365 5,533 6,182
-------- -------- -------- --------
-------- -------- -------- --------
Adjusted EBITDA margin % 18.3% 22.8% 17.5% 22.3%
-------- -------- -------- --------
-------- -------- -------- --------
(1) Rent expense on the Canadian facility, as a result of the sale-
leaseback transaction from November 1, 2005 to April 16, 2007 (see
below).
While operating as a segment of our former parent company, Akela Pharma
Inc. ("Akela"), we entered into a sale-leaseback transaction on the Canadian
facility, which took effect on November 1, 2005. On April 17, 2007, following
the Initial Public Offering ("IPO"), and in accordance with our strategic
growth plan, we reacquired the property. Accordingly, prior to November 1,
2005 and after April 16, 2007, "amortization" includes amortization of the
related building and "interest, net" includes interest expense on the
long-term debt secured by the building. Between November 2005 and April 2007,
while the sale-leaseback transaction was in effect, amortization and interest
expense related to the building was replaced by "rent expense" in our
statements of earnings.
(b) Gross margin
Gross margin refers to revenues less direct costs. Direct costs do not
include depreciation expense of assets used in our direct operations.
The following table presents our gross margins from continuing activities
by reporting periods.
Three months Six months
ended ended
June 30 June 30
2008 2007 2008 2007
-------- -------- -------- --------
(in thousands of dollars) $ $ $ $
Revenues 16,120 14,742 31,549 27,727
Direct costs 10,882 8,935 21,247 16,928
-------- -------- -------- --------
Gross Margin 5,238 5,807 10,302 10,799
-------- -------- -------- --------
-------- -------- -------- --------
Gross Margin % 32.5% 39.4% 32.7% 38.9%
-------- -------- -------- --------
-------- -------- -------- --------
LAB RESEARCH INC.
Consolidated Balance Sheets
(Unaudited)
June 30, 2008 and December 31, 2007
(in thousands of Canadian dollars)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
June 30, December 31,
2008 2007
-------------------------------------------------------------------------
(audited)
Assets
Current assets:
Cash and cash equivalents $ 4,511 $ 6,825
Accounts and other receivables 10,574 9,450
Work in progress 4,525 2,913
Income taxes receivable 3,202 1,894
Prepaid expenses 1,090 1,361
Future income taxes 906 916
-----------------------------------------------------------------------
24,808 23,359
Property and equipment 81,164 60,176
Intangible assets 2,023 2,076
Other assets 3,574 3,598
Future income taxes 3,398 3,435
-------------------------------------------------------------------------
$114,967 $ 92,644
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable and accrued liabilities $ 9,260 $ 10,066
Building expansions related accounts payable 7,111 1,607
Deferred revenue 8,873 7,949
Current portion of long-term debt 2,667 2,111
Holdback payable 1,442 203
Future income taxes 579 585
-----------------------------------------------------------------------
29,932 22,521
Long-term debt 45,314 33,825
Future income taxes 1,903 1,924
Shareholders' equity:
Share capital 63,873 63,753
Additional paid-in capital 882 682
Accumulated other comprehensive
earnings (loss) 643 (1,186)
Deficit (27,580) (28,875)
-----------------------------------------------------------------------
37,818 34,374
-------------------------------------------------------------------------
$114,967 $ 92,644
-------------------------------------------------------------------------
-------------------------------------------------------------------------
LAB RESEARCH INC.
Consolidated Statements of Earnings
(Unaudited)
Periods ended June 30, 2008 and 2007
(in thousands of Canadian dollars, except per share and share data)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Three months Six months
ended June 30, ended June 30,
--------------------- ----------------------
2008 2007 2008 2007
-------------------------------------------------------------------------
Revenues $ 16,120 $ 14,742 $ 31,549 $ 27,727
Expenses:
Direct costs 10,882 8,935 21,247 16,928
Selling, general and
administrative 2,765 2,303 5,204 4,627
Stock-based compensation 114 113 231 226
Amortization of property
and equipment 1,164 838 2,267 1,528
Amortization of
intangible assets 139 130 271 265
Interest, net 562 338 1,106 409
Foreign exchange (586) 166 (619) 205
-----------------------------------------------------------------------
15,040 12,823 29,707 24,188
-------------------------------------------------------------------------
Earnings before income
taxes from continuing
operations 1,080 1,919 1,842 3,539
Provision for income taxes 332 304 547 668
-------------------------------------------------------------------------
Net earnings from
continuing operations 748 1,615 1,295 2,871
Net loss from discontinued
operations - (25) - (74)
-------------------------------------------------------------------------
Net earnings $ 748 $ 1,590 $ 1,295 $ 2,797
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Earnings per share:
Basic:
Continuing operations $ 0.04 $ 0.09 $ 0.07 $ 0.16
Discontinued operations - - - -
-----------------------------------------------------------------------
$ 0.04 $ 0.09 $ 0.07 $ 0.16
-------------------------------------------------------------------------
Diluted:
Continuing operations $ 0.04 $ 0.09 $ 0.07 $ 0.16
Discontinued operations - - - (0.01)
-----------------------------------------------------------------------
$ 0.04 $ 0.09 $ 0.07 $ 0.15
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Weighted average number
of outstanding shares:
Basic 18,062,526 18,035,714 18,056,615 18,035,714
Effect of
dilutive options 415,237 352,159 412,704 233,664
-------------------------------------------------------------------------
Diluted 18,477,763 18,387,873 18,469,319 18,269,378
-------------------------------------------------------------------------
-------------------------------------------------------------------------
LAB RESEARCH INC.
Consolidated statements of Cash Flows
(Unaudited)
Periods ended June 30, 2008 and 2007
(in thousands of Canadian dollars)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Three months Six months
ended June 30, ended June 30,
---------------------- -----------------------
2008 2007 2008 2007
-------------------------------------------------------------------------
Cash flows from
operating activities:
Net earnings $ 748 $ 1,590 $ 1,295 $ 2,797
Net loss from
discontinued operations - 25 - 74
-------------------------------------------------------------------------
Net earnings from
continuing operations 748 1,615 1,295 2,871
Adjustments for:
Amortization of property
and equipment 1,164 838 2,267 1,528
Amortization of
intangible assets 139 130 271 265
Unrealized gain on
foreign exchange (127) (30) (147) (10)
Stock-based compensation 114 113 231 226
Future income taxes (144) (344) (248) (1,017)
Other 5 69 14 89
Net changes in non-cash
operating assets
and liabilities (1,448) (2,408) (2,743) (1,946)
-------------------------------------------------------------------------
451 (17) 940 2,006
Net cash from operations
provided by discontinued
operations - 97 - 175
-------------------------------------------------------------------------
451 80 940 2,181
Cash flows from financing
activities:
Proceeds from issuance
of shares 89 - 89 -
Proceeds from issuance
of long-term debt 11,305 23,100 11,358 23,100
Repayment of
long-term debt (640) (3,138) (1,060) (3,356)
Repayment of capital leases (165) (138) (291) (289)
Repayments under bank
credit facilities - - - (223)
-------------------------------------------------------------------------
10,589 19,824 10,096 19,232
Cash flows from
investing activities:
Cash held in escrow - 500 - -
Payment of holdback payable (59) (34) (59) (835)
Additions to property
and equipment (9,650) (20,230) (13,016) (23,340)
Proceeds from disposal
of property and equipment - 69 - 86
Loan receivable - (300) - (300)
Other assets 7 27 (7) 19
-------------------------------------------------------------------------
(9,702) (19,968) (13,082) (24,370)
Effect of exchange rate
changes on cash and
cash equivalents (478) (105) (268) (92)
-------------------------------------------------------------------------
Net increase (decrease)
in cash and cash equivalents 860 (169) (2,314) (3,049)
Cash and cash equivalents,
beginning of period 3,651 5,636 6,825 8,516
-------------------------------------------------------------------------
Cash and cash equivalents,
end of period $ 4,511 $ 5,467 $ 4,511 $ 5,467
-------------------------------------------------------------------------
-------------------------------------------------------------------------
>>
%SEDAR: 00023798EF
SOURCE: LAB RESEARCH INC.
LAB Research Inc.: Luc Mainville, President and Chief Executive Officer, (450) 973-2240, ext. 1206, mainvillel@labresearch.com, www.labresearch.com; Media and Investors: Echoes Financial Network Inc.: Dominic Sicotte, (866) 633-9551, (514) 842-9551, dsicotte@echoesfinancial.com
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Companies: LAB Research Inc (LRI)
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