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Advances product pipeline; new regulatory submissions expected before year end
TORONTO, Aug. 9 /PRNewswire-FirstCall/ -- Predictive medicine company PreMD Inc. (TSX: PMD; Amex: PME) today announced results for the second quarter of fiscal 2006 ended June 30, 2006 (Q2 2006).
Recent Highlights
- Exceeded the enrollment target in the 600-subject PASA study with a
total of 650 patients enrolled. This study is aimed at expanding
PREVU(x) Point of Care (POC) Skin Sterol Test's regulatory claim in
the United States to include risk assessment of heart attack and
stroke;
- Reported positive preliminary data on PREVU(x) LT Skin Sterol Test
from the life insurance industry study (PREPARE) that demonstrated
statistically significant relationships and is supportive of the
study's primary objective;
- Submitted a Special 510(k) application to U.S. Food and Drug
Administration (FDA) for clearance of an enhanced color reader for
PREVU(x) POC;
- Received clearance from Health Canada's Therapeutic Products
Directorate as well as a Conformite Europeene (CE) Mark for the new
color reader, which validates the viability of the product and allows
it to be marketed in Canada and in the European Union; and
- Presented data on a new LungAlert(TM) test format at the American
Association for Clinical Chemistry Annual Meeting.
The consolidated net loss for Q2 2006 was $2,115,000 or $0.10 per share compared with a loss of $1,455,000 or $0.07 per share for the quarter ended June 30, 2005 (Q2 2005). For the six months ended June 30, 2006, the net loss was $4,489,000, or $0.21 per share, compared with $2,757,000, or $0.13 per share for the six months ended June 30, 2005, primarily due to increased research and development expenses related to the acceleration of clinical trials in 2006 and to interest and imputed interest expenses on convertible debentures issued on August 30, 2005. The Company expects research and development expenses to return to lower than historical levels in the second half of fiscal 2006. Cash used to fund operating activities during Q2 2006 amounted to $1,835,000 compared with $1,164,000 in Q2 2005, the increase resulting from increased expenditures on clinical trials.
Total product related sales to McNeil Consumer Healthcare were $5,000 for Q2 2006 compared with $333,000 for Q2 2005. McNeil continues to use inventory purchased in 2005 for sales and marketing proposals to potential customers and has purchased only a small quantity of new products so far in 2006. License revenue was $80,000 for Q2 2006, approximately the same as for Q2 2005.
"We are pleased with the advancements we are making, particularly with the completion of enrollment in the PREPARE and PASA clinical trials," said Dr. Brent Norton, President and Chief Executive Officer. "Preliminary results from PREPARE are positive and we are moving quickly to complete the analysis while working with McNeil Consumer Healthcare to finalize the regulatory and marketing strategies for PREVU(x) LT in 2006. We will also be analyzing the data from PASA in the coming months and expect to be in a position to make various regulatory submissions to the FDA and regulatory authorities in Canada and Europe before the end of the year. Additionally, we have expanded enrollment in the I-ELCAP trial, which we expect to provide important new data on LungAlert(TM) later this year."
Outlook
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"We believe that a number of McNeil's market evaluations for PREVU(x) are gaining traction, which we expect to see build through the year, particularly as the new reader becomes available," continued Dr. Norton. "We are making excellent progress against our objectives and anticipate revenues and additional milestone payments related to the successful completion of our strategic objectives. As these goals are achieved, we expect to move toward breaking even, possibly by the end of 2006."
PreMD's near-term objectives include:
- Achieve regulatory clearance for PREVU(x) LT to enable marketing
launch;
- Achieve new regulatory claim for PREVU(x) in the U.S. as a test to
predict risk of heart attack and stroke;
- Complete analysis of new LungAlert(TM) data and expand participation
in I-ELCAP to additional sites;
- Complete pivotal study for the breast cancer test at the University
of Louisville and initiate an additional clinical trial for
ColorectAlert(TM); and
- Conclude a strategic partnership for PreMD's cancer products.
PREVU(x) Commercialization Update
---------------------------------
McNeil is advancing initiatives in targeted segments of the risk assessment market as well as the life insurance industry:
- McNeil will showcase the new handheld PREVU(x) POC spectrometer to
cardiologists and other medical professionals at the World Congress
of Cardiology 2006, an event organized by the European Society of
Cardiology and the World Heart Federation, to be held in Barcelona,
Spain in September.
- McNeil's pilot program with Costco, held at two retail locations in
Florida in March, is expected to be rolled out to additional stores
in the southeastern U.S. in the fourth quarter. Additionally, McNeil
is working to significantly extend its previous retail pilot program
with Wal-Mart in Quebec this fall in response to favorable customer
and retailer feedback.
- McNeil has completed a sales broker contract with Medivon, LLC, a
Florida-based healthcare company that provides heart disease risk
assessment programs. Medivon has selective rights in the U.S. to
promote the use of PREVU(x) POC with selected customers.
- In the life insurance market, McNeil's efforts to raise awareness of
PREVU(x) LT with life insurance companies include presentations at
the recent annual meetings of the Canadian Institute of Underwriters
(CIU) and the SouthEastern Home Office Underwriters' Association
(SEHOUA).
- McNeil continues to evaluate opportunities in the occupational health
market, which includes employee health fairs and programs, and has
established an industry advisory board. This advisory board met in
May at the American College of Occupational and Environmental
Medicine conference to discuss PREVU(x) POC and establish contacts
with industry thought leaders.
Financial Review
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During Q2 2006, the Company focused on accelerating key clinical trials to obtain additional claims for PREVU(x) POC and to obtain regulatory clearance for PREVU(x) LT, the company's skin sterol test for the life insurance industry. As a result, research and development expenditures increased by $665,000 to $1,470,000 from $805,000 in Q2 2005. The variance for the quarter reflects:
- an increase of $851,000 in spending on clinical trials for the
company's family of skin sterol tests, particularly related to the
PREPARE and PASA trials, as well as clinical trials for the lung,
colorectal and breast cancer technologies;
- a decrease of $85,000 in legal fees on intellectual property; and
- a decrease of $96,000 in subcontract research due to the completion
of the development of the second-generation spectrometer.
Total research and development expenditures for the six months ended June 30, 2006 and 2005 amounted to $2,986,000 and $1,448,000, respectively. As a result of the completion of enrolment in the above-noted trials, clinical trial costs are expected to decline significantly for the balance of 2006.
General and administration expenses amounted to $689,000 for Q2 2006 compared with $770,000 in Q2 2005, a decrease of $81,000. The decrease for the quarter reflects a decrease of $74,000 in expenses related to investor communications. For the six months ended June 30, 2006, general and administration expenses amounted to $1,266,000, a decrease of $269,000 from the corresponding period in 2005.
Interest on convertible debentures (issued on August 30, 2005) amounted to $173,000 in Q2 2006 compared with nil in Q2 2005. For the six months ended June 30, 2006, interest amounted to $338,000 compared with nil for the corresponding period in 2005. The debentures bear interest at an annual rate of 7%, payable quarterly in either cash or common shares. The expense for Q2 2006 was paid in common shares, of which 40,561 were issued during the quarter and 31,065 were issued subsequent to the quarter, on July 5, 2006.
Imputed interest for the three and six months ended June 30, 2006 amounted to $205,000 and $404,000, respectively, compared with nil for the corresponding periods in 2005. It is a non-cash expense and represents the amortization of the fair value of the warrants and equity component of the debentures over the life of the debentures.
Amortization expenses for equipment and acquired technology for Q2 2006 amounted to $46,000 compared with $54,000 for Q2 2005. For the six months ended June 30, 2006 and 2005, amortization amounted to $89,000 and $106,000, respectively. Purchases of capital assets amounted to $3,000 during Q2 2006 compared with $81,000 in Q2 2005.
Amortization of deferred financing fees related to the convertible debentures amounted to $32,000 in Q2 2006 ($65,000 for the six months ended June 30, 2006) compared with nil in Q2 2005. The financing fees are being amortized over the life of the convertible debentures.
The gain on foreign exchange for Q2 2006 amounted to $278,000 compared with $12,000 for the corresponding period in 2005. Included in the gain for 2006 is $425,000 resulting from the effects of foreign exchange on the convertible debentures which are repayable in U.S. dollars. It is partially offset during the quarter by a loss on the revaluation of investments held in U.S. dollars, amounting to $163,000. For the six months ended June 30, 2006 and 2005, the gain on foreign exchange amounted to $215,000 and $13,000, respectively.
Refundable scientific investment tax credits (ITCs) accrued for Q2 2006 amounted to $70,000 versus $48,000 for Q2 2005. For the six months ended June 30, 2006 and 2005, the ITC revenue amounted to $130,000 and $98,000, respectively.
Interest income amounted to $70,000 for Q2 2006 compared with $22,000 for Q2 2005 as a result of higher cash balances. For the six months ended June 30, 2006 and 2005, interest income amounted to $157,000 and $51,000, respectively.
As at June 30, 2006, PreMD had cash, cash equivalents and short-term investments totaling $5,888,000 ($8,679,000 as at December 31, 2005). The Company invests its funds in short-term financial instruments and marketable securities. Cash used to fund operating activities during Q2 2006 amounted to $1,835,000 compared with $1,164,000 in Q2 2005, the increase resulting from the increased expenditures on clinical trials.
To date, the Company has financed its activities through product sales, license revenues, the issuance of shares and convertible debentures and the recovery of ITCs. Management believes that clinical trial expenses will be reduced dramatically for the balance of 2006 and for 2007 and that, based on historic cash expenditures and the current expectation of further revenues from product sales, royalties and license fees, its existing cash resources together with the ITC receivable of $330,000 will be sufficient to meet its current operating and capital requirements through at least 2008.
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Conference Call and Webcast
PreMD will hold a conference call and webcast tomorrow, Thursday,
August 10, 2006, at 10 a.m. ET. To access the conference call, please
dial 1-800-866-5043. A live audio webcast will be available at
http://www.premdinc.com/, and will be subsequently archived for three months. To
access the replay via telephone, which will be available until Thursday,
August 17, 2006, please dial (416) 640-1917 or (877) 289-8525 and enter
the passcode 21199051 followed by the number sign.
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About PreMD Inc.
PreMD Inc. is a world leader in predictive medicine, dedicated to developing rapid, non-invasive tests for the early detection of life-threatening diseases. PreMD's cardiovascular products, which are branded as PREVU(x) Skin Sterol Test, are licensed worldwide to McNeil Consumer Healthcare. The company's cancer tests include ColorectAlert(TM), LungAlert(TM) and a breast cancer test. PreMD's head office is located in Toronto, and its research and product development facility is at McMaster University in Hamilton, Ontario. For further information, please visit http://www.premdinc.com/. For more information about PREVU(x), please visit http://www.prevu.com/ or call 1-866-283-8328 (North America) or 00-800-8283-8328 (Europe), or email .
This news release contains forward-looking statements, including the Company's expectations related to future performance. Known and unknown risks and uncertainties that could cause the Company's actual results to differ materially from those in the forward-looking statements include, among others: the successful and timely completion of clinical studies; the successful development or marketing of the Company's products and the competitiveness of the Company's products if successfully commercialized; whether reimbursement for the Company's products will be available and the potential impact of reimbursement policies imposed by third-party payers on the development, usage and pricing of the Company's products; the lack of operating profit and availability of funds and resources to pursue R&D projects and clinical trials; product liability; the Company's reliance on third-party manufacturers; the ability of the Company to take advantage of business opportunities; uncertainties related to the Company's presentation of data to regulatory authorities and the approval of marketing applications by regulatory authorities; and general changes in economic conditions. In addition, while the Company routinely obtains patents for its products and technology, the protection offered by the Company's patents and patent applications may be challenged, invalidated or circumvented by its competitors and there can be no guarantee of the Company's ability to obtain or maintain patent protection for its products or product candidates.
Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions, available at http://www.sedar.com/ and http://www.sec.gov/, for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned not to rely on these forward-looking statements. The Company is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this news release as a result of new information, future events or otherwise.
(x) Trademark
PreMD Inc.
Incorporated under the laws of Canada
CONSOLIDATED BALANCE SHEETS
(In Canadian dollars)
As at June 30, 2006 and December 31, 2005
Unaudited
June 30, December 31,
2006 2005
$ $
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ASSETS
Current
Cash and cash equivalents 90,801 773,199
Short-term investments 5,797,510 7,905,883
Accounts receivable - 881,891
Inventory 35,638 36,306
Prepaid expenses and other receivables 225,603 317,264
Investment tax credits receivable 330,000 200,000
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Total current assets 6,479,552 10,114,543
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Deferred financing fees, net of accumulated
amortization of $108,157 (2005 - $43,059) 412,627 477,725
Capital assets, net of accumulated
amortization of $782,589 (2005 - $721,784) 370,746 410,636
Acquired technology, net of accumulated
amortization of $885,999 (2005 - $856,970) 261,257 290,286
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7,524,182 11,293,190
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LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIENCY)
Current
Accounts payable 721,748 291,125
Accrued liabilities 665,719 655,113
Current portion of deferred revenue 306,900 311,915
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Total current liabilities 1,694,367 1,258,153
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Convertible debentures 5,913,256 5,893,340
Deferred revenue 2,143,823 2,297,400
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Total liabilities 9,751,446 9,448,893
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Shareholders' equity (deficiency)
Capital stock 24,546,459 24,449,826
Contributed surplus 2,161,979 1,840,979
Equity component of convertible debentures 2,393,145 2,393,145
Warrants 1,373,718 1,373,718
Deficit (32,702,565) (28,213,371)
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Total shareholders' equity (deficiency) (2,227,264) 1,844,297
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7,524,182 11,293,190
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PreMD Inc.
CONSOLIDATED STATEMENTS OF LOSS AND DEFICIT
(In Canadian dollars)
Unaudited
Three months ended Six months ended
June 30 June 30
------------------------ ------------------------
2006 2005 2006 2005
$ $ $ $
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REVENUE
Product sales 5,015 332,701 5,132 345,060
License revenue 79,624 78,081 156,675 154,806
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84,639 410,782 161,807 499,866
Cost of product sales 4,255 319,322 4,383 330,551
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Gross Profit 80,384 91,460 157,424 169,315
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EXPENSES
Research and
development 1,469,815 805,088 2,985,524 1,447,574
General and
administration 688,617 769,537 1,265,865 1,534,912
Interest on convertible
debentures 172,623 - 338,137 -
Imputed interest on
convertible debentures 205,269 - 404,132 -
Amortization 77,561 53,705 154,932 106,011
Gain on foreign
exchange (277,675) (11,537) (215,043) (13,047)
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2,336,210 1,616,793 4,933,547 3,075,450
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RECOVERIES AND OTHER
INCOME
Investment tax credits 70,000 47,923 130,000 97,923
Interest 70,394 22,383 156,929 51,273
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140,394 70,306 286,929 149,196
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Net loss for the
period (2,115,432) (1,455,027) (4,489,194) (2,756,939)
Deficit, beginning
of period (30,587,133) (24,525,578) (28,213,371) (23,223,666)
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Deficit, end of
period (32,702,565) (25,980,605) (32,702,565) (25,980,605)
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Basic and diluted
loss per share $(0.10) $(0.07) $(0.21) $(0.13)
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Weighted average
number of common
shares outstanding 21,566,994 21,529,262 21,559,121 21,434,065
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PreMD Inc.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In Canadian dollars)
Unaudited
Three months ended Six months ended
June 30 June 30
------------------------ ------------------------
2006 2005 2006 2005
$ $ $ $
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OPERATING ACTIVITIES
Net loss for the
period (2,115,432) (1,455,027) (4,489,194) (2,756,939)
Add items not
involving cash
Amortization 77,561 53,705 154,932 106,011
Stock-based
compensation costs
included in:
Research and
development
expense 58,904 58,122 94,719 88,443
General and
administration
expense 173,741 183,477 243,212 282,027
Imputed interest
on convertible
debentures 205,269 - 404,132 -
Interest on convertible
debentures paid in
stock 79,702 - 79,702 -
Deduct gain on
foreign exchange (277,675) (11,537) (215,043) (13,047)
Net change in non-cash
working capital
balances related to
operations 44,745 83,858 1,296,533 (444,739)
Decrease in deferred
revenue (81,867) (76,725) (158,592) (153,450)
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Cash used in operating
activities (1,835,052) (1,164,127) (2,589,599) (2,891,694)
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INVESTING ACTIVITIES
Short-term
investments 1,695,094 1,009,887 1,881,904 2,645,617
Purchase of capital
assets (2,817) (80,511) (20,915) (115,776)
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Cash provided by
investing activities 1,692,277 929,376 1,860,989 2,529,841
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FINANCING ACTIVITIES
Issuance of capital
stock, net of issue
costs - - - 198,400
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Cash provided by
financing activities - - - 198,400
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Effect of exchange rate
changes on cash and
cash equivalents 4,145 1,270 46,212 (844)
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Net decrease in cash
and cash equivalents
during the period (138,630) (233,481) (682,398) (164,297)
Cash and cash
equivalents
- Beginning of period 229,431 308,642 773,199 239,458
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- End of period 90,801 75,161 90,801 75,161
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Represented by:
Cash 90,801 75,161 90,801 75,161
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90,801 75,161 90,801 75,161
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DATASOURCE: PreMD Inc.
CONTACT: Sarah Borg-Olivier, Director, Communications, T: (416) 222-3449,
; Ron Hosking, Chief Financial Officer, T : (416)
222-3449,