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Company Links |
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Major Stock Holders
(Prior To
Offering) |
Name |
Class A |
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Ann Barlow |
6.20% |
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David S. Barlow |
13.80% |
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James Poitras |
6.50% |
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John Babich |
3.10% |
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Stephen Feinberg |
13.60% |
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Business Environment |
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In the United States, approximately five to eight million chest pain patients present to emergency departments each year to determine whether their chest pain is caused by cardiac ischemia or myocardial infarction (heart attack). Of these chest pain patients, over three million are admitted to the hospital to achieve diagnosis, of which only approximately 15% are ultimately diagnosed with acute coronary syndrome, or ACS, an umbrella term which refers to cardiac ischemia and myocardial infarction. These life-threatening disorders are a major cause of emergency medical care and hospitalization.
Because of the limitations associated with the current standard of care to detect ACS in the emergency department, diagnosis continues to be a source of uncertainty and error. Moreover, the current standard of care to detect ACS also results in a high rate of “missed” diagnoses. Of the approximately 25% of patients with chest pain who are discharged from the emergency department having not been diagnosed with ACS or admitted for further assessment, 1% to 5% actually have ACS.
Unnecessary hospitalizations and “missed” diagnoses are costly in many ways. The current standard of care to detect ACS results in an estimated $3 to $6 billion per year in inpatient expenses that could be avoided with an improved diagnostic. The complications in discharged patients whose ACS is “missed” account for approximately 20% of malpractice awards against emergency department physicians, even though patients with chest pain comprise approximately 6% of a typical emergency physician’s practice.
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Company Strategy |
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A biopharmaceutical company focused on the research, development and commercialization of innovative molecular imaging pharmaceuticals and targeted radiotherapeutics. |
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Product/Services Portfolio |
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The lead product candidate, Zemiva (iodofiltic acid I 123), is a radiolabeled fatty acid analog that the Company is developing as a molecular imaging pharmaceutical for the diagnosis of insufficient blood flow to the heart, or cardiac ischemia. The Company has recently completed a Phase 2b clinical trial for Zemiva. In this clinical trial, the Company evaluated the safety and efficacy of Zemiva and initial findings suggest that Zemiva has the ability to detect areas of cardiac ischemia with results generally consistent with the current standard of care. Moreover, Zemiva appeared to have significant predictive value in ruling out cases in which cardiac ischemia was not present.
Zemiva is a radiolabeled fatty acid analog that is also known as BMIPP. This molecule has been sold in Japan under the name Cardiodine in the non-acute setting for over ten years and no significant safety events have been reported. Cardiodine has been used in over 500,000 patients and has been the subject of over 200 peer-reviewed articles.
The Company is conducting discovery studies on second-generation fatty acid compounds that are based on enhanced structural features of Zemiva, as well as on third-generation fatty acid analogs that will focus on a new class of proprietary radiolabeled fatty acid analogs. The Company believes that these compounds may provide it with a robust, patented and differentiated extension to the Zemiva franchise.
Prostate cancer is the most commonly diagnosed cancer among men in the United States, with approximately 230,000 men newly diagnosed each year. The Company is engaged in discovery studies of radiopharmaceuticals to bind to prostate specific membrane antigen, or PSMA, that would allow it to image the tumor and monitor response therapy. This technology employs a novel class of synthetic dipeptides used in conjunction with the Company’s SAAC technology. The Company believes that its approach should lead to new targeting molecules that would allow it to image angiogenesis in a variety of tumors and to monitor response to anti-angiogenic tumor therapy.
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Investment Analysis |
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Revenue increased $179.0 thousand, or 72%, to $427.0 thousand for the six months ended June 30, 2005 from $248.0 thousand for the six months ended June 30, 2004.
Research and development expense increased $2.0 million, or 101%, to $4.0 million for the six months ended June 30, 2005 from $2.0 million for the six months ended June 30, 2004.
General and administrative expense increased $1.5 million, or 99%, to $3.0 million for the six months ended June 30, 2005 from $1.5 million for the six months ended June 30, 2004.
Other income, net increased $115.0 thousand to $126.0 thousand for the six months ended June 30, 2005 from $11.0 thousand for the six months ended June 30, 2004.
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Income Data (Thousand $ Except EPS) |
| Year |
Revenues |
Costs |
Oper Income |
Taxes |
Net Income |
EPS |
| 2002
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624,161 |
7,676,894 |
-7,052,733 |
0.00 |
-7,083,506 |
-0.63 |
| 2003
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723,475 |
4,040,811 |
-3,317,336 |
0.00 |
-3,347,727 |
-0.19 |
| 2004
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569,273 |
8,901,173 |
-8,331,900 |
0.00 |
-8,315,403 |
-0.42 |
| 2005
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426,962 |
7,031,748 |
-6,604,786 |
0.00 |
-6,478,554 |
-0.33 |
| *As of period Ended June 30, 2005
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Balance Sheet Data
(Thousand $) |
Year |
Cash |
Acct Recv. |
Inventory |
Total Cur Assets |
Total Cur Liability |
PPE |
Total Assets |
LT Debt |
SH Equity |
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2003 |
1,710,500 |
49,378 |
0.00 |
1,835,997 |
3,544,895 |
383,830 |
2,232,118 |
0.00 |
-9,022,844 |
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2004 |
846,154 |
86,465 |
0.00 |
1,187,162 |
3,753,164 |
378,803 |
1,572,856 |
0.00 |
-17,831,229 |
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2005 |
21,152,694 |
125,308 |
0.00 |
21,521,815 |
2,373,678 |
388,286 |
21,911,992 |
0.00 |
-24,360,807 |
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*As of period Ended June 30, 2005
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| Cash
Flow Summary
(Thousand $) |
Year |
Net Cash-Ops |
Net Cash-Inv |
Net Cash-Fin |
Net Change |
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2002 |
-2,284,417 |
-24,964 |
1,105,256 |
-1,204,125 |
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2003 |
-3,026,275 |
-26,148 |
4,749,833 |
1,697,410 |
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2004 |
-6,167,335 |
-202,542 |
5,505,531 |
-864,346 |
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2005 |
-6,322,032 |
-88,172 |
26,716,744 |
20,306,540 |
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*As of period Ended June 30, 2005
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