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Financial Performance & Scoring -- © 2005 Gaskins IPO Desktop/IPOdesktop |
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Analysis of 15 Biotech, Biopharma, Medical Device, Medical-related pre-IPO companies |
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. Opening Premium Star Ratings: |
1-Star--Flat to up $0.38; 2-Stars--Up $0.50 to $1; |
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3-Stars-UP $1 to $3; 4-Stars--$4 and higher; 5-Stars--Moonshot, 100% plus |
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. Business Model Rating Criteria |
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A = high growth market, potential leader; B = more competitive market; C='public venture capital' |
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. Calculations |
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. IPO Price to annualized Sales Ratio -- (Price / Sales) |
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Numerator |
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Denominator |
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IPO market capitalization… |
Annualized Sales (last quarter's revenues times 4) |
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(post-IPO # of shares times mid-point of IPO price range) |
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. IPO Price to annualized Earnings (loss) -- (Price / Earnings) |
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Numerator |
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Denominator |
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IPO market cap |
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Annualized Earnings (loss) from the last quarter |
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Use 'Edit, find on this page' to search for companies |
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VALUATION RATIOS |
IPO Mrkt |
Price / |
Price / |
Price / |
Price / |
% offered |
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Cap (mm) |
Sales |
Earnings |
BookValue |
TangibleBV |
in IPO |
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March 8 |
CombinatoRx (CRXX |
223 |
n/a |
-10.0 |
2.4 |
2.4 |
30% |
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new medicines from synergistic combinations of approved drugs |
Post-IPO shrs:20.3mm |
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March 4 |
AsprevaPharma ASPV |
461 |
124.7 |
-19.2 |
3.7 |
3.7 |
22% |
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commercializes approved drugs |
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Post-IPO shrs:32.95mm |
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Feb 25 |
Targacept (TRGT) |
244 |
66.1 |
-10.2 |
2.1 |
2.1 |
31% |
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biopharmaceutical |
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Post-IPO shrs:20.37mm |
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Jan 21 |
ViaCell (VIAC) |
289 |
3.2 |
26.7 |
4.0 |
4.4 |
21% |
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biotechnology company enabling the use of human cells as medicine |
Post-IPO shrs:36.1mm |
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Dec 14 |
Conor Med (CONR) |
368 |
n/a |
-17 |
3.5 |
3.5 |
16% |
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stents for vascular drug delivery |
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Post-IPO:30.7mm shrs |
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Dec 10 |
Adeza Biomd (ADZA) |
239 |
7.3 |
39 |
3.5 |
3.5 |
24% |
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patented diagnostic test, the Fetal Fibronectin Test |
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Post-IPO:15.9 mm shrs |
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Dec6midwk |
CABG Med (CABG) |
87 |
n/a |
-30 |
3.0 |
3.0 |
35% |
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artificial coronary graft system |
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Post-IPO: 15.8 mm shrs |
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Dec 8 |
OccuLogix (RHEO) |
376 |
622.3 |
63 |
1.7 |
8.0 |
20% |
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innovative treatments for eye diseases |
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Post-IPO:41.76mm shrs |
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Dec 9 |
SYMMETRY Md SMA |
459 |
2.2 |
31 |
2.5 |
11.0 |
24% |
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implants, elated instruments & cases for orthopedic device manufacturers. |
Post-IPO: 32.8mm shrs |
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Oct 20 |
VNUS Medical (VNUS) |
192 |
5.6 |
112 |
3.4 |
3.4 |
35% |
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medical devices for minimally invasive treatment of venous reflux disease |
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Oct 14 |
CoTherix (CTRX) |
176 |
n/a |
-5 |
2.4 |
2.4 |
26% |
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biopharmaceutical: therapeutics for life threatening diseases. |
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Oct 7 |
IntraLase (ILSE) |
305 |
6.0 |
-38 |
3.5 |
3.5 |
26% |
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laser technology for the first step of LASIK surgery |
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Sept 28 |
Theravance (THRX) |
583 |
81.0 |
-6 |
2.9 |
3.6 |
12% |
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biopharmaceutical company |
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Sept 23 |
Cogent Sys (COGT) |
741 |
10.8 |
49 |
5.9 |
5.9 |
23% |
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provider of Automated Fingerprint Identification Systems, or AFIS |
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Sept 22 |
Nephros (NEP) |
78 |
n/a |
-11 |
5.8 |
5.8 |
32% |
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development stage medical device and technology company |
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========================================================================= |
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SEARCH BY COMPANY |
Use 'Edit, find on this page' to search for companies |
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pre-IPO scheduled date |
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March 8 |
CombinatoRx |
CRXX, 2-Stars, C |
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new medicines from synergistic combinations of approved drugs |
Post-IPO shrs:20.3mm |
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Boston, MA |
2001 |
2002 |
2003 |
2004 |
IPO Mkt |
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Revenue ($mm) |
none |
none |
none |
none |
Cap (mm) |
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R&D |
3.8 |
9.9 |
12.1 |
15.9 |
$223 |
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Income (loss) ($mm) |
-$5.6 |
-$13.6 |
-$16.3 |
-$22.3 |
@$11 |
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VALUATION RATIOS |
IPO Mrkt |
Price / |
Price / |
Price / |
Price / |
% offered |
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Cap (mm) |
Sales |
Earnings |
BookValue |
TangibleBV |
in IPO |
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March 8 |
CombinatoRx (CRXX), CRXX, 2-Stars |
223 |
n/a |
-10.0 |
2.4 |
2.4 |
30% |
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SCORECARD |
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Mgt |
Market |
Market Do- |
Proprie- |
Total |
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1-5, 5 is high |
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Growth |
mination |
tary |
rating |
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20 is perfect |
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2 |
2 |
0 |
2 |
6 |
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Business |
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Developing new medicines built from synergistic combinations of approved drugs. |
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cHTS approach |
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. CRXX. Uses its combination high throughput screening, or cHTS, technology, to systematically |
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screen pair-wise combinations from its library of approximately 2,000 United States, European |
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and Japanese approved drugs |
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. In cell-based assays corresponding to major diseases such as cancer, rheumatoid arthritis, |
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asthma, psoriasis and diabetes. |
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. Using these cell-based assays, cHTS technology screens the effects of millions of possible |
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dose-specific combinations of existing drugs in each of our selected disease models. |
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Discoveries |
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. Has discovered pairs of approved drugs which in preclinical studies exhibit a therapeutic effect |
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against a model for a target disease when applied in combination, |
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. Even though neither drug is indicated for such disease on its own. |
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. Also discovered pairs of drugs where CRXX's preclinical studies suggest the effectiveness or |
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safety of one drug in its primary disease indication may be improved by combining it with another |
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drug that, on its own, is not indicated for that disease. |
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Advantages of CRXX's Approach |
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. Early stage drug candidates often fail. |
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. CRXX'ss approach seeks to address this high failure rate by pursuing a portfolio strategy for drug |
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discovery and development. |
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. By applying cHTS technology to screen for the biological effects of combinations of approved |
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drugs in disease models |
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. CRXX has identified multiple product candidates for selected major diseases and advanced them |
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into proof-of-concept clinical trials. |
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Active ingredients are approved drugs |
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. Because the active pharmaceutical ingredients in CRXX"s product candidates are themselves |
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approved drugs |
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. CRXX has been able to move seven of product candidates into human clinical studies without the |
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need to first complete many of the extensive preclinical toxicology and pharmacology studies |
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generally required before initiating clinical trials for a new chemical entity. |
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. This approach allows CRXX to make early development decisions based studies in patients, |
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rather than only on studies in animals. |
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Product candidates |
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Immuno-Inflammatory Disease Program |
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. CRXX currently has six clinical stage product candidates targeting immuno-inflammatory |
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diseases and multiple additional preclinical product candidates. |
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Oncology (cancer) Program |
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. CRXX's oncology product pipeline includes dual-action agents in clinical and preclinical |
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development. |
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Metabolic Diseases and Other Preclinical Programs |
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. CRXX's preclinical pipeline includes multiple product candidates targeted for potential |
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development in Type II diabetes, other metabolic diseases, oncology and multiple immuno |
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inflammatory diseases. |
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Clinical Status |
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. Five product candidates are in proof-of-concept studies in patients, or phase IIa trials, and a sixth |
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product candidate is planned to enter phase IIa clinical trials in 2005. |
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. In addition, CRXX is testing our oncology product candidate in patients with advanced cancers |
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who have failed one or more prior therapies. These oncology trials, referred to here as phase I/II |
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trials, are designed to evaluate safety, response rate, dosage levels and other factors. |
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Competition |
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. Will be competing against a wide range of pharmaceutical and life science companies that have |
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greater resources |
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Discovery technology |
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. Seeks to create barriers to entry for other pharmaceutical companies by filing patent applications |
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for technology and by protecting trade secrets |
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. Many companies have already developed and employ high throughput screening technologies. . |
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Should these companies seek to apply these technologies to the discovery of combination drugs, |
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CRXX drug discovery technology may be rendered obsolete or noncompetitive. |
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Use of $59.8mm in IPO proceeds |
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• Development of our current portfolio of seven clinical stage product candidates; |
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• Development of our preclinical stage product candidates. |
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• Discovery and development of additional product candidates; |
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• Further development of drug discovery technology; and |
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• Working capital, capital expenditures and other general corporate purposes. |
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March 4 |
Aspreva Pharma |
ASPV, 1-Star, C |
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commercializes approved drugs |
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Post-IPO shrs:32.95mm |
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Victoria, British Columbia, Canada |
2002 |
2003 |
2004 |
IPO Mkt |
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Revenue ($mm) |
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none |
none |
none |
Cap (mm) |
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R&D |
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0.07 |
1.20 |
10.10 |
$461 |
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Income (loss) ($mm) |
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-$0.2 |
-$2.5 |
-$22.5 |
@$14 |
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VALUATION RATIOS |
IPO Mrkt |
Price / |
Price / |
Price / |
Price / |
% offered |
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Cap (mm) |
Sales |
Earnings |
BookValue |
TangibleBV |
in IPO |
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March 4 |
AsprevaPharma ASPV |
461 |
124.7 |
-19.2 |
3.7 |
3.7 |
22% |
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SCORECARD |
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Mgt |
Market |
Market Do- |
Proprie- |
Total |
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1-5, 5 is high |
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Growth |
mination |
tary |
rating |
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20 is perfect |
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2 |
2 |
1 |
1 |
6 |
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Business |
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Commercializes new indications for approved drugs and drug candidates for underserved |
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patient populations. |
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Strategy |
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. Collaborate with pharmaceutical and biopharmaceutical companies to pursue new |
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indication approvals which lie beyond their strategic focus. |
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. Intends to assume the clinical, regulatory and commercial activities for these non-core |
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indications of collaborators’ existing drugs. |
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. Seeks collaborations with companies that have approved drugs and drug candidates |
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that ASPV believes have compelling scientific, clinical and commercial potential. |
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Example |
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. CellCept is a drug currently approved in the United States, European Union, Canada |
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and other countries for the prevention of organ transplant rejection. |
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ASPV believes that CellCept also has the potential to be effective in treating a variety of |
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autoimmune diseases. |
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Collaboration with Roche |
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. In July 2003, entered into first collaboration with Roche for the drug CellCept. |
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. ASPV is responsible for clinical development, preparing regulatory filings and, following |
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regulatory approval, commercialization, marketing and promotion of CellCept for use in |
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autoimmune indications. |
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. Roche will manufacture, distribute and record sales of CellCept. |
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. Starting April 1, 2005 and during the term of the agreement, Roche is obligated to pay, |
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on a quarterly basis, an amount equal to half of any incremental net sales of CellCept |
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attributed to the use of CellCept for non-transplant indications above a negotiated |
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baseline of 134 million Swiss Francs, or CHF, per year. |
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Competition |
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CellCept |
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. In the transplant market, CellCept currently competes with Myfortic, which is marketed |
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by Novartis. Myfortic is approved only for the prevention of kidney rejection. If additional |
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indications are approved for CellCept, Novartis may choose to compete in these markets |
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by also pursuing clinical trials in autoimmune indications. |
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. If approved, CellCept will compete with immunosuppressants, the current standard of |
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care for the treatment of autoimmune diseases, such as steroids and cytotoxic agents, |
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including cyclophosophamide, cyclosporine and azathioprine. |
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. In addition, ASPV is aware that the following companies have products in development |
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or on the market that may be competitive with CellCept in lupus nephritis: La Jolla |
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Pharmaceuticals Co., Prometheus Laboratories, Inc., Human Genome Sciences Inc., |
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Genelabs Technologies Inc., Genentech Inc., Teva Pharmaceuticals Ltd., Novartis AG |
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and Bristol Myers Squibb Co. |
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. ASPV is also aware that the following companies have products in development that |
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may be competitive with CellCept in myasthenia gravis: Novo Nordisk A/ S, Corixa |
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Corporation and Cambridge Neuroscience, Inc. |
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. Ttwo companies are developing potential therapies for pemphigus vulgaris: Alexion |
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Antibody Technologies, Inc. and Peptimmune, Inc. |
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Use of $90.7mm in IPO proceeds |
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• $14.0 million to commence planned Phase III clinical trial for the use of CellCept in the |
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induction and maintenance treatment of lupus nephritis; |
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• $6.0 million to continue Phase III clinical trial for the use of CellCept to treat myasthenia |
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gravis; |
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• $5.0 million to continue Phase III clinical trial for the use of CellCept to treat pemphigus |
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vulgaris; |
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• $15.0 million to fund market research, continuing medical education, medical liaisons |
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and product launch preparation for CellCept. |
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=================================== |
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note: TRGT was postponed |
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Feb 25 |
Targacept (TRGT) |
TRGT, 1-Star, C |
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biopharmaceutical |
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Post-IPO shrs:20.37mm |
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Winston-Salem, North Carolina |
2002 |
2003 |
2004 |
IPO Mkt |
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Revenue ($mm) |
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$2.3 |
$2.5 |
$3.7 |
Cap (mm) |
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R&D |
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$16 |
$18 |
$23 |
$244 |
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Income (loss) ($) |
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-$21 |
-$19 |
-$24 |
@$12 |
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VALUATION RATIOS |
IPO Mrkt |
Price / |
Price / |
Price / |
Price / |
% offered |
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Cap (mm) |
Sales |
Earnings |
BookValue |
TangibleBV |
in IPO |
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Feb 25 |
Targacept (TRGT) |
244 |
66.1 |
-10.2 |
2.1 |
2.1 |
31% |
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SCORECARD |
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Mgt |
Market |
Market Do- |
Proprie- |
Total |
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1-5, 5 is high |
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Growth |
mination |
tary |
rating |
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20 is perfect |
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2 |
2 |
1 |
1 |
6 |
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Business |
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. Biopharmaceutical targeting a new class of drugs to treat multiple diseases and disorders |
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. By selectively targeting a class of receptors known as neuronal nicotinic acetylcholine receptors, |
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or NNRs. |
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. Has worldwide commercialization rights for all of product candidates |
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Focus and product candidates |
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. Three therapeutic areas: cognitive impairment, pain and depression. |
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. Within these areas, has three product candidates in clinical development and three preclinical |
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product candidates |
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. Expects to advance one of the preclinical product candidates into clinical development in the first |
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half of 2005. |
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. Also has multiple preclinical programs for target indications outside these areas, which TRGT |
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believes NNRs can be exploited for medical benefit. |
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Inversein |
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Product candidate currently in a Phase II clinical trial as an add-on therapy in patients with major |
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depressive disorder, is approved in the United States for moderately severe to severe essential |
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hypertension. |
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TRGT believes that Inversine is the only FDA-approved product designed to target an NNR. |
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Sources of revenue |
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. Since August 2000, funded operations primarily through private placement of equity securities |
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and, to a much lesser extent, through payments received from our collaborators, equipment and |
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building lease incentive financing, sales of our product Inversine and government grants. |
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History |
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. Traces scientific lineage to a research program initiated by R.J. Reynolds Tobacco Company in |
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1982 to study the activity and effects of nicotine in the body and the function of nicotinic |
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acetylcholine receptors. |
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. Incorporated in Delaware in 1997 as a wholly owned subsidiary of RJR. |
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. In August 2000, we became an independent company when we issued shares of our series B |
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convertible preferred stock to outside investors. |
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Competition |
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Substantial competition from therapies designed to target NNRs (neuronal nicotinic acetylcholine |
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receptors) |
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. Pfizer, with an NNR-targeted compound in Phase III for smoking cessation, and Abbott |
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Laboratories, with an NNR-targeted compound in Phase II for Alzheimer’s disease, ADHD and |
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schizophrenia and a second NNR-targeted compound in Phase I for pain. |
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. In addition, companies with active NNR-based research programs include Merck & Co., |
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AstraZeneca, Eli Lilly, Sanofi-Synthélabo, Memory Pharmaceuticals, Critical Therapeutics and |
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NeuroSearch A/S. |
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While there is currently no approved product either for AAMI or for cognitive impairment |
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associated with schizophrenia, primary competitive products include |
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• for mild to moderate Alzheimer’s disease, acetylcholinesterase inhibitors such as Aricept from |
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Pfizer, Reminyl from Johnson & Johnson and Exelon from Novartis and for moderate to severe |
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Alzheimer’s disease, Namenda from Forest Laboratories, which acts by regulating the |
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neurotransmitter glutamate; |
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• for pain, non-steroidal anti-inflammatory drugs such as Celebrex from Pfizer and opioids such as |
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OxyContin from Purdue Pharma; |
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• for depression, selective serotonin reuptake inhibitors such as Prozac from Eli Lilly, |
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Paxil/Seroxar from GlaxoSmithKline, Zoloft from Pfizer, Celexa from Forest Laboratories and |
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Lexapro from Forest Laboratories and the dual uptake inhibitor Effexor from Wyeth; |
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• for schizophrenia, anti-psychotics such as Zyprexa from Eli Lilly, Risperdal from Johnson & |
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Johnson and Abilify from Bristol-Myers Squibb; and |
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• for smoking cessation, Zyban from GlaxoSmithKline. |
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Use of $67.8mm in IPO proceeds |
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Fund clinical trials, preclinical testing and other research and development activities |
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• $25 million to fund further development of ispronicline, product candidate for conditions marked |
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by cognitive impairment that afflict the elderly, including Alzheimer’s disease and AAMI; |
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• $2 million to fund further development of TC-1827, product candidate for cognitive impairment |
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associated with schizophrenia; |
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• $12 million to fund further development of TC-2696, product candidate for acute post-operative |
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pain; |
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• $3 million to complete ongoing Phase II clinical trial of Inversine as an add-on therapy in |
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patients with major depressive disorder; |
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• $2 million to conduct the additional preclinical toxicology studies necessary to support an IND |
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for clinical trials of TC-2216; and |
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• $24 million to fund general and administrative expenses, other research and development |
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expenses, working capital needs and other general corporate purposes. |
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==================================== |
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Jan 21 |
ViaCell |
VIAC, 2-Stars, B- |
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biotechnology company enabling the use of human cells as medicine |
Post-IPO shrs:36.1mm |
|
Boston, MA |
2001 |
2002 |
2003 |
Sept 9 mos |
IPO Mkt |
|
|
Revenue (mm) ($) |
$7.3 |
$20.4 |
$31.9 |
$28.6 |
Cap (mm) |
|
|
Gross margin % |
57.5% |
71.1% |
77.6% |
80.7% |
$289 |
|
|
R&D |
$7.0 |
$11.4 |
$13.2 |
$11.7 |
@$8 |
|
|
Inprocess tech* |
$0.6 |
$5.9 |
$23.9 |
|
|
|
|
*cost of acquiring technology |
|
|
|
|
|
|
Income (loss) ($) |
-22.1 |
-36.0 |
-55.5 |
-15.9 |
|
|
|
Income (loss) (%) |
-302.7% |
-176.5% |
-174.0% |
-55.6% |
|
|
|
VALUATION RATIOS |
IPO Mrkt |
Price / |
Price / |
Price / |
Price / |
% offered |
|
|
Cap (mm) |
Sales |
Earnings |
BookValue |
TangibleBV |
in IPO |
|
Jan 21 |
ViaCell (VIAC) |
289 |
3.2 |
-14.4 |
4.0 |
4.4 |
21% |
|
SCORECARD |
|
Mgt |
Market |
Market Do- |
Proprie- |
Total |
|
1-5, 5 is high |
|
|
Growth |
mination |
tary |
rating |
|
20 is perfect |
|
2 |
3 |
1 |
2 |
8 |
|
Business |
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|
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enabling the use of human cells as medicine |
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. An early stage of development for cellular therapeutic candidates and has recently initiated the |
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first clinical trial for the lead product candidate, CB001. |
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|
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. Developing a pipeline of other proprietary product candidates intended to address cancer, cardiac |
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diseases, and infertility. |
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|
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. Also has a commercial business dedicated to the preservation of umbilical cord blood, an |
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abundant source of stem cells for potential therapeutic use. |
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|
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. Currently generates revenue from cord blood preservation activities, which VIAC markets as its |
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Viacord product. |
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Collaborations |
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. In December 2003, VIAC entered into a license and collaboration agreement with Amgen under |
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which VIAC received a non-exclusive license to certain Amgen stem cell growth factors for use in |
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developing and manufacturing cell therapy products |
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|
|
|
. Amgen received an option to collaborate with VIAC on development and commercialization of |
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any product, including CB001, that incorporates an Amgen growth factor or technology. |
|
|
. Amgen made a $20 million equity investment in VIAC. |
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|
|
|
. In addition, VIAC has an agreement with Genzyme, an equity investor in ViaCell, under which |
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Genzyme provides scientific support in the area of islet stem cell research. |
|
|
. VIAC also has entered into relationships with academic institutions and other companies. |
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Product and Product Candidates |
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CB001 |
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. Lead cellular therapy product candidate, CB001, is initially being developed by us for use as a |
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substitute for bone marrow and other hematopoietic stem cell transplants. CB001 is a proprietary, |
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highly concentrated and purified population of stem cells |
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. Currently enrolling patients in a Phase I clinical trial |
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Viacord |
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. Viacord customers are expectant parents who have entrusted us with their child’s umbilical cord |
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blood, which VIAC processes into a cellular therapeutic and cryopreserve, or preserve by freezing, |
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for potential future use by that child or a sibling |
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|
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|
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. VIAC believes it is one of the leaders in the emerging private, or family, cord blood preservation |
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industry. |
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Oocytes |
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. Preservation and storage of human oocytes: VIAC has an exclusive license to a proprietary |
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cryopreserving media that allows VIAC to preserve oocytes. A study of the application of this |
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media published in Human Reproduction, a peer-reviewed journal, documented four pregnancies |
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and five live births following 11 embryo transfers. VIAC is working with in vitro fertilization |
|
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centers to demonstrate additional births using this technology. |
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Intellectual Property |
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. Currently owns or has exclusively in-licensed the five US patents |
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|
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. Three of the owned and issued US patents are directed to methods of manufacturing target |
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populations of primary cells for use as cellular medicines. These patents broadly cover the use of |
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selection elements to select a target population of cells continuously, intermittently during, or after |
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a culture phase. |
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|
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|
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. The Selective Amplification technology covered by these patents is core to the manufacture of |
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VIAC's lead stem cell product candidate, CB001. These patents expire in 2014 if not extended. |
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Corresponding international applications are pending. |
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|
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. One of VIAC's owned and issued US patents is directed to the method of making hemangioblast |
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cells from a neonatal source. This patent broadly covers the derivation and growth of human |
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hemangioblasts from a non-fetal source. This patent expires in 2017 if not extended. |
|
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Corresponding international applications are pending. |
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|
|
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. One of VIAC's exclusively in-licensed and issued US patents is directed to a method of |
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cryopreserving human oocytes. This patent is broadly directed at cryopreservation of a human |
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oocyte, using proprietary media so that the oocyte enters into a dormant state and is then stored for |
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future use. This patent expires in 2017 if not extended. |
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|
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. VIAC owns two pending US patent applications directed to compositions and methods of using |
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USSCs to treat a broad class of diseases. |
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. Furthermore, VIAC owns outright or has exclusively in-licensed 52 international patent |
|
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applications. |
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. In addition, VIAC has non-exclusive licenses to 30 US patents and patent applications and 86 |
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foreign patents and patent applications, including patents covering growth factors used in VIAC's |
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Selective Amplification process. |
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Competition |
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Stem cell therapy competitors |
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. Stem cell therapy competitors with products that could potentially compete with CB001 include |
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commercial and development-stage companies offering or intending to offer stem cell products |
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derived from bone marrow, cord blood or mobilized peripheral blood, or devices or services for |
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processing and producing cells derived from these tissues, for use in stem cell transplants. Specific |
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competitors include Aastrom Biosciences, Celgene, Cellerant, Gamida-Cell and Osiris |
|
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Therapeutics. Companies with the most advanced products potentially competitive with CB001 |
|
include Gamida-Cell and Osiris Therapeutics. |
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. Gamida-Cell, a private company based in Israel, has a hematopoetic stem cell product candidate |
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made from umbilical cord blood that is intended for use in hematopoietic stem cell transplants, |
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similar to CB001. Gamida-Cell’s product candidate is currently being evaluated in a Phase I |
|
clinical trial. Osiris Therapeutics, a private company based in the US, has a mesenchymal stem |
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cell product candidate isolated from bone marrow that is intended for use in conjunction with |
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transplantation of conventional bone marrow or cord blood cells. Osiris’ product candidate has |
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already completed Phase I testing. |
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. In addition to these cell therapy products, competition for CB001 may be in the form of new and |
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better drugs to treat leukemias, lymphomas, myelomas and certain genetic diseases. |
|
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Stem cell therapies |
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. VIAC is aware of several competitors developing stem cell therapies for the treatment of cardiac |
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disease, including GenVec, Genzyme, Bioheart, Osiris Therapeutics, and potentially others. |
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GenVec, Genzyme, and Bioheart are all developing products consisting of skeletal myoblasts |
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isolated from muscle, expanded in culture, and injected into a patient’s heart to repair dead tissue. |
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All three companies’ products are currently in clinical studies: Bioheart completed a Phase I study |
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in 2002; GenVec is currently conducting its Phase I study; and Genzyme is currently recruiting |
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patients for its Phase II study. Osiris’s product candidate consists of mesenchymal stem cells |
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isolated from donor bone marrow, expanded in culture, and is intended to be injected into a |
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patient’s heart to prevent scar tissue. Osiris has publicly stated that it intends to file an IND to |
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begin clinical studies in 2004. Other companies, including Hydra Biosciences, have pre-clinical |
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development efforts using growth factors to stimulate repair of endogenous heart tissue. |
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Cord blood preservation |
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. Competitors in the cord blood preservation industry include the approximately 20 other national |
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private family cord blood banks in the United States, including California Cryobank, Cbr Systems |
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(Cord Blood Registry), Cryo-Cell International, CorCell, LifeBankUSA, and New England Cord |
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Blood Bank. |
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. Some of the competitors, including Cryo-Cell, CorCell, and LifeBankUSA, charge a lower price |
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for their products than we do. |
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. Other competitors such as LifeBankUSA, a division of Celgene, a publicly traded corporation, |
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may have greater financial resources. |
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|
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. There are also more than fifty public cord blood banks throughout the world, including the New |
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York Blood Center (National Cord Blood Program), University of Colorado Cord Blood Bank, |
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Milan Cord Blood Bank, Düsseldorf Cord Blood Bank, and others. |
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Oocyte preservation |
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. Compeitors are expected to include IVF centers and individual companies that offer oocyte |
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preservation. |
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. VIAC is are aware of 20 IVF centers already offering oocyte preservation, which may make it |
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more difficult for to establish a product or achieve a significant market share. |
|
|
. IVF centers currently offering this service include Florida Institute for Reproductive Medicine, |
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Stanford University, The Jones Institute for Reproductive Medicine, and Egg Bank USA (through |
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Advanced Fertility Clinic). |
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. Companies offering oocyte preservation include Extend Fertility. |
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|
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Cord Blood Stem Cell Act. |
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. The Cord Blood Stem Cell Act of 2003, or the CBSCA, is currently being considered by the U.S. |
|
Congress. |
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. If enacted, it would provide federal funding for a national system of public cord blood banks in |
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order to increase the number of available cord blood units to at least 150,000 units. |
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. It also contains provisions designed to encourage cord blood donations from an ethnically diverse |
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population. |
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. Under the CBSCA, a public cord blood bank could obtain federal funding from this program if |
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the bank meets eligibility requirements established by the CBSCA. |
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|
. The CBSCA is not applicable to family cord blood banks such as Viacord, and Viacord would |
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not be eligible for federal funding under the CBSCA. |
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Other |
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|
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. ViaCell plans to obtain cord blood units to manufacture CB001 from public cord blood banks. |
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An increase in the number and availability of public cord blood units could increase the available |
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units for use in manufacturing CB001. Alternatively, an increase in the number of available cord |
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blood units in public banks could have an adverse effect on the market for CB001 or other of our |
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potential cell therapy products. |
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|
|
|
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. If public cord blood banks are able to increase their inventories and obtain more units with a |
|
higher volume of stem cells, then public cord blood banks may be able to better compete with |
|
VIAC's potential cell therapy products. |
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Use of $53mm in IPO proceeds |
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|
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• $15.0 million for conducting a Phase II clinical trial for CB001, assuming successful completion |
|
of the Phase I clinical trial for CB001 currently underway; |
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• $5.0 million for preclinical research and development activities relating to product candidates; |
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• $15.1 million for repayment of principal and interest on a $14.0 million note issued as partial |
|
consideration in the acquisition of Kourion Therapeutics in 2003; and |
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|
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• $18.2 million for general corporate purposes, including working capital needs, and potential |
|
acquisitions of technologies or businesses or the establishment of partnerships and collaborations |
|
================================= |
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Dec 14 |
Conor Medsystems |
CONR, 2-Stars, C |
|
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|
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stents for vascular drug delivery |
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|
Post-IPO:30.7mm shrs |
|
Menlo Park, CA |
2001 |
2002 |
2003 |
Sept 9 mos |
IPO Mkt |
|
|
Revenue (mm) ($) |
none |
$0.1 |
none |
none |
Cap (mm) |
|
|
R&D ($mm) |
$1.4 |
$3.6 |
$9.2 |
$11.9 |
$368 |
|
|
Income (loss) ($) |
-$2.0 |
-$5.0 |
-$11.0 |
-$15.8 |
@$12 |
|
|
VALUATION RATIOS |
IPO Mrkt |
Price / |
Price / |
Price / |
Price / |
% offered |
|
|
Cap (mm) |
Sales |
Earnings |
BookValue |
TangibleBV |
in IPO |
|
Dec 14 |
Conor Med (CONR) |
368 |
n/a |
-17 |
3.5 |
3.5 |
16% |
|
SCORECARD |
|
Mgt |
Market |
Market Do- |
Proprie- |
Total |
|
1-5, 5 is high |
|
|
Growth |
mination |
tary |
rating |
|
20 is perfect |
|
1 |
2 |
1 |
2 |
6 |
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Business |
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. Controlled vascular drug delivery technologies |
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. Initially focused on the development of drug eluting stents to treat coronary artery disease, |
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a market that CONR believes will grow to over $6 billion by 2008. |
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|
|
. Stents are tubular mesh devices consisting of interconnected metal struts that are inserted inside |
|
an artery to act as scaffolding, propping open a narrowed blood vessel. |
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|
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Products |
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|
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. CONR stents have been specifically designed for vascular drug delivery, in contrast to currently |
|
available drug eluting stents, which are conventional bare metal stents coated with a drug and |
|
polymer. |
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. A polymer is a substance used to adhere a drug to the surface of a stent and to modulate its |
|
release. |
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. CONR stents incorporate hundreds of small holes, each acting as a reservoir into which CONR |
|
can load a drug-polymer composition. |
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Competition |
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Marketing treatments for restenosis |
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|
|
. In particular, Boston Scientific Corporation has developed a paclitaxel eluting stent, the |
|
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TAXUS™ Express 2™ stent, which is marketed in the United States, Europe and other |
|
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international markets. |
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|
|
. Johnson & Johnson has developed a stent coated with rapamycin, the CYPHER™ stent, which is |
|
marketed in the United States and Europe. The TAXUS™ Express 2™ stent and the CYPHER™ |
|
stent are currently the only FDA approved drug eluting stents in the United States. |
|
|
. In addition, Guidant Corporation, Abbott Laboratories, Biocompatibles International plc and |
|
Medtronic, Inc. are all developing drug eluting stents. |
|
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|
|
. All of the drug eluting stents that have been publicly disclosed as being under development by |
|
other companies are surface-coated stents. |
|
|
|
|
|
. Many of these companies claim that their drug eluting stents provide the ability to control release |
|
kinetics. |
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Boston Scientific |
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|
|
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|
|
|
. In August 2004, Boston Scientific announced that it had begun patient enrollment in a pivotal |
|
study to collect data to support regulatory filings required to commercialize its new TAXUS™ |
|
Liberte™ paclitaxel-coated coronary stent as a platform for its next-generation drug eluting |
|
coronary stent system. |
|
|
|
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|
|
. Boston Scientific has stated that the trial is designed to assess the safety and efficacy of a slow |
|
release dose formulation for the treatment of coronary disease and that the TAXUS™ Liberte™ |
|
stent system is designed to further enhance the stent's deliverability and conformability, |
|
|
particularly in challenging lesions. |
|
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|
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|
|
Use of $54mm in IPO proceeds from sale of 5mm shares |
|
|
|
|
. $41mm for product development |
|
|
|
|
|
|
. $7mm for sales & marketing |
|
|
|
|
|
|
. Balance for working capital and general corporate purposes |
|
|
|
===================================== |
|
|
|
|
Dec 10 |
Adeza Biomedical |
ADZA, 2-Stars, C+ |
|
|
|
|
|
patented diagnostic test, the Fetal Fibronectin Test |
|
Post-IPO:15.9 mm shrs |
|
Sunnyvale, CA |
2001 |
2002 |
2003 |
Sept 9 mos |
IPO Mkt |
|
|
Revenue (mm) ($) |
$6.7 |
$14.3 |
$26.5 |
$24.5 |
Cap (mm) |
|
|
Gross margin % |
62.7% |
74.1% |
77.0% |
85.3% |
$239 |
|
|
Income (loss) ($) |
$5.0 |
$5.0 |
$5.0 |
$4.6 |
@$15 |
|
|
Income (loss) (%) |
74.6% |
35.0% |
18.9% |
18.8% |
|
|
|
Not included: accrued royalties, should have been amortized |
$2.7 |
|
|
|
VALUATION RATIOS |
IPO Mrkt |
Price / |
Price / |
Price / |
Price / |
% offered |
|
|
Cap (mm) |
Sales |
Earnings |
BookValue |
TangibleBV |
in IPO |
|
Dec 10 |
Adeza Biomd (ADZA) |
239 |
7.3 |
39 |
3.5 |
3.5 |
24% |
|
SCORECARD |
|
Mgt |
Market |
Market Do- |
Proprie- |
Total |
|
1-5, 5 is high |
|
|
Growth |
mination |
tary |
rating |
|
20 is perfect |
|
2 |
2 |
2 |
2 |
8 |
|
Business |
|
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|
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|
|
. Innovative products for women’s health |
|
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|
|
. Initial focus is on reproductive healthcare, using proprietary technologies to predict preterm birth |
|
and assess infertility |
|
|
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|
|
|
|
Product |
|
|
|
|
|
|
|
. Patented diagnostic test, the Fetal Fibronectin Test, that utilizes a single-use, disposable cassette |
|
and is analyzed on ADZA's patented instrument, the TLiIQ System. |
|
|
|
. Product is approved by the Food and Drug Administration, or FDA, for broad use in assessing |
|
the risk of preterm birth. |
|
|
|
|
|
|
. Designed to objectively determine a woman’s risk of preterm birth by detecting the presence of a |
|
specific protein, fetal fibronectin, in vaginal secretions during pregnancy. |
|
|
|
. Testing for fetal fibronectin during pregnancy provides a more accurate assessment of the |
|
likelihood of a preterm birth than traditional methods. |
|
|
|
|
Preterm births |
|
|
|
|
|
|
|
. According to the New England Journal of Medicine, preterm births have historically accounted |
|
for up to 85% of all pregnancy-related complications and deaths in the United States. |
|
|
. The March of Dimes estimated that over $13 billion in costs were associated with the care of |
|
preterm or low birth weight infants in 2001. |
|
|
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|
|
Three patient categories |
|
|
|
|
|
|
. Women who present with signs and symptoms of preterm labor and are typically directed to the |
|
hospital. |
|
|
|
|
|
|
|
. Second and third categories include women designated as either "high-risk" or "low-risk" for |
|
preterm birth by their healthcare providers, and who currently exhibit no signs and symptoms of |
|
preterm labor. |
|
|
|
|
|
|
|
. ADZA believes that by using the Fetal Fibronectin Test periodically during a pregnancy, |
|
healthcare providers can more accurately assess the likelihood that women in all three categories |
|
will not deliver preterm. |
|
|
|
|
|
|
|
Market size |
|
|
|
|
|
|
|
. ADZA estimates that its product has a potential market size in the first two patient categories is |
|
of over $400 million annually. |
|
|
|
|
|
|
. If ADZA is able to expand the use of the Fetal Fibronectin Test for women designated as "low |
|
risk" and for other uses, ADZA estimates the potential annual market size can be greater than $1 billion. |
|
Competition |
|
|
|
|
|
|
|
. ADZA is currently the only provider of a fetal fibronectin test for predicting preterm birth. |
|
. Competitors could use other biomarkers, including cytokines and other proteins indicative of |
|
infection, and proteomics are the subject of research that may yield new products or technologies. |
|
. Healthcare providers use diagnostic techniques such as clinical examination and ultrasound to |
|
diagnose the likelihood of preterm birth. Healthcare providers may choose to continue using these |
|
techniques to assess their patients, rather than use ADZA's Fetal Fibronectin Test |
|
|
Use of $50.5mm in IPO proceeds |
|
|
|
|
|
|
. $15.0 million to expand our sales and marketing efforts in the United States and internationally; |
|
. $8.0 million for research and development activities related to product development, clinical |
|
trials and regulatory approvals for additional indications for the Fetal Fibronectin Test in the |
|
United States and internationally. Potential additional indications include induction of labor, |
|
prediction of delivery date and bladder cancer monitoring. |
|
|
|
|
. $7.0 million for research & development activities for oncology-related products & other |
|
|
areas; |
|
|
|
|
|
|
|
. Balance for working capital and other general corporate purposes, including $5.0 million for |
|
investment in working capital related to expected increases in accounts receivable and inventory |
|
and $2.5 million for increases in general and administrative costs |
|
|
|
==================================== |
|
|
|
|
Dec6midwk |
CABG Medical (CABG) |
CABG, 1-Star, C |
|
|
|
|
|
artificial coronary graft system |
|
|
|
Post-IPO: 15.8 mm shrs |
|
Minneapolis, MN |
2001 |
2002 |
2003 |
Sept 9 mos |
IPO Mkt |
|
|
Revenue (mm) ($) |
none |
none |
none |
none |
Cap (mm) |
|
|
R&D |
$0.7 |
$0.6 |
$1.2 |
$1.6 |
$87 |
|
|
Income (loss) ($) |
-$0.7 |
-$0.7 |
-$1.5 |
-$2.2 |
@$11 |
|
|
VALUATION RATIOS |
IPO Mrkt |
Price / |
Price / |
Price / |
Price / |
% offered |
|
|
Cap (mm) |
Sales |
Earnings |
BookValue |
TangibleBV |
in IPO |
|
Dec6midwk |
CABG Med (CABG) |
87 |
n/a |
-30 |
3.0 |
3.0 |
35% |
|
SCORECARD |
|
Mgt |
Market |
Market Do- |
Proprie- |
Total |
|
1-5, 5 is high |
|
|
Growth |
mination |
tary |
rating |
|
20 is perfect |
|
2 |
2 |
0 |
2 |
6 |
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Business |
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. Developmental stage medical technology company seeking to improve the treatment of coronary |
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heart disease, or CHD, by advancing conventional bypass surgery. |
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. Created an artificial coronary graft system "Holly Graft System |
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. The Holly Graft System has not yet received regulatory approval for sale anywhere in the world |
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and will not be commercially available for several years, if ever. |
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Trials |
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. CABG has conducted a limited number of preclinical animal tests of the Holly Graft System and |
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expects to complete the first human implant of the Holly Graft System in the fourth quarter of '04 |
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. CABG expects to continue implant efforts in Australia and to commence human clinical trials in |
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Europe in 2005. |
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Employees |
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. CABG has eight full-time employees and is led by a team of experienced medical technology |
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industry executives and recognized experts in cardiac surgery and cardiovascular research. |
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. CABG intends to add employees following this offering. |
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. Manny Villafaña, Chairman and Chief Executive Officer, has previously introduced innovative |
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cardiac surgery products such as pacemakers and heart valves throughout the world and founded |
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companies such as Cardiac Pacemakers, Inc. (now Guidant Corporation), St. Jude Medical, Inc. |
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and ATS Medical, Inc. |
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The need |
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. Today’s coronary bypass procedure typically requires two surgeries: one to harvest either or both |
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of the principal superficial veins in the leg, or saphenous veins, or radial arteries from the arms, |
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and a second to implant the harvested vessels as grafts. |
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. The harvesting of vessels increases the risk of infection, pain, swelling caused by a buildup of |
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watery fluid in the cellular tissue, or edema, and other adverse complications, while adding time, |
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cost and complexity to the bypass procedure. Unsightly scarring of legs or arms remains a lifelong |
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legacy of vessel harvesting. |
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. According to the study: "Endoscopic Versus Open Saphenous Vein Harvest: A Comparison of |
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Postoperative Wound Complications" published in 2002 by the Annals of Thoracic Surgery, |
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approximately twenty percent of such patients experience some type of complication as a result of |
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a traditional saphenous vein harvesting. Patients who are obese, diabetic or both are particularly at |
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risk for such complications. |
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. While surgical techniques such as endoscopic vein harvesting can reduce the number of |
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complications to approximately four percent, these techniques do not eliminate the need for |
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harvesting vessels, nor do they eliminate resulting complications. A significant portion of patients |
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suffering such complications require rehospitalization, the costs of which typically must be |
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absorbed by the hospitals and payors. |
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. In addition, the saphenous vein harvesting approach assumes the availability of suitable vessels |
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from the patient, which is often not the case, particularly in the elderly or in patients suffering |
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from diabetes, obesity or other forms of cardiovascular disease. |
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Market |
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. CABG's technology is intended to obviate the need for vessel harvesting surgery. |
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. The American Heart Association, or AHA, reports that in the United States alone during 2001, |
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over 300,000 patients had bypass surgery largely requiring saphenous vein grafts, or SVGs. |
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. CABG estimates the market for the rest of the world to be roughly equal in size to that of the |
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United States. |
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. Over the last several years, the total number of patients undergoing bypass surgery has decreased |
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as a result of new, less invasive therapies such as pharmacotherapy, angioplasty and stenting. |
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. Any future decline in the total number of patients undergoing bypass surgery could decrease |
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CABG's potential market both prior to and after commercialization. |
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CABG's solution |
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. Numerous efforts to develop an artificial coronary graft using materials that mimic the natural |
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structure of the coronary artery have been attempted, including porcine conduit, tissue engineered |
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grafts and grafts made from synthetic materials. |
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. Thus far, none have been approved by the United States Food and Drug Administration, or FDA. |
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CABG believes previous artificial grafts were primarily focused on ascertaining the appropriate |
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tissue or materials on which to base the graft, rather than the mechanics of blood flow and the |
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corresponding influence on graft patency (openness). |
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. CABG believes artificial graft work and continuous high blood flow and pressure, coupled with |
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drug combinations, are the critical elements necessary to adequately limit or obviate clotting and |
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tissue formation in an artificial graft system, each of which can adversely impact vessel patency. |
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. CABG expects that its Holly Graft System will provide cardiac surgeons with a new technology |
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that will be differentiated and innovative in the worldwide market for coronary artery bypass |
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grafting, or CABG, procedures. |
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Animal tests |
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. Based on the animal tests CABG has performed to date, CABG believes the Holly Graft System |
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should be at least as effective as the traditional SVG procedure in restoring blood circulation in |
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coronary arteries without the negative side effects of saphenous vein harvesting. |
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. In terms of maintaining graft patency, CABG's system delivers critical continuous high blood |
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flow from the aorta to the target vessel, thereby diminishing the greater susceptibility of clotting |
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and tissue formation associated with low flow situations. |
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. Typically, harvested vessels are low flow due to the termination of flow at the target vessel. |
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. The Holly Graft System is able to maintain continuous high flow and pressure because of the |
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following characteristics: |
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• Larger Diameter: Our graft consists of a 6 mm diameter conduit compared to the typical 2-3 mm |
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harvested conduit. The increase in size allows for increased flow. |
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• Healthier Conduits: The Holly Graft System provides surgeons with a plaque free, consistent |
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and reliable source of conduit for grafts, which are free from disease. Patients suffering from CHD |
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commonly have a build up of fatty deposits inside the arterial walls, or atherosclerosis, or other |
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conditions causing marginal quality vessels (particularly those individuals with obese and diabetic |
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conditions) that immediately threaten the patency of harvested SVGs and other vessels. |
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Note: saphenous vein grafts (SVGs) |
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• Flow Limiter: The Holly Graft System utilizes a flow limiter which maintains pressure within |
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the graft and creates pressure to feed the target coronary artery through the system’s vessel |
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connectors. |
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• Drug Combinations: The vessel connectors used in the Holly Graft System are coated with the |
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same drug combination that is used on certain prominent drug-eluting stents. In our animal trials, |
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these drug combinations prevented the buildup of tissue proximate to the grafting site, which can |
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result in post-operative obstructions or closures of vessels, or occlusions, in the same manner in |
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which the combination prevents the recurrence of a blockage, or restenosis, in stenting procedures. |
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Accordingly, we believe that these drug combinations will limit the risk of an interruption of the |
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Holly Graft System. Obtaining a license to such a drug combination is critical to the |
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commercialization of the Holly Graft System. |
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Physician Preference |
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. Assuming CABG's clinical studies prove that the Holly Graft System is as effective as SVGs, |
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CABG believes many cardiac surgeons will readily accept and utilize the Holly Graft System in |
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order to reduce operating time and avoid the patient discomfort, scarring and frequent |
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complications associated with the surgery to remove the saphenous vein. |
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. Although endoscopic harvesting procedures can reduce the complication rate associated with |
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saphenous vein harvesting, the training required to learn the technique is significant and |
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proficiency is generally not obtained until a physician performs the procedure on numerous |
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patients. |
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. To the best of CABG's knowledge, no statistics on the usage of endoscopic procedures are |
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available, but due to above-mentioned factors, CABG believes that the preponderance of |
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saphenous vein harvesting is performed by the traditional "open procedure" and that the majority |
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of endoscopic procedures are performed at large heart centers that perform a significant number of |
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bypass procedures each year. Additionally, endoscopic procedures still (i) require a second |
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surgery; (ii) result in scarring; and (iii) only reduce the incidence of, but do not eliminate |
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complications associated with saphenous vein harvesting. |
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Patents |
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. CABG has obtained two United States patents, applied for four additional United States patents |
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on various aspects of the Holly Graft System, and is seeking licenses for other aspects |
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. Has filed foreign applications in the European Union, Japan, China, Australia, Brazil, Canada, |
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Argentina and Hong Kong. |
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Competition |
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. Medtronic, Inc., Guidant Corporation, St. Jude Medical, Inc., Thoratec Corporation and Edwards |
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Lifesciences Corporation, are working on products similar to CABG's artificial coronary graft as |
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well as other competing products or therapies, including stenting, angioplasty and |
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pharmacological therapies. |
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. CAGB currently faces direct competition from CardioTech International, Inc., a company that is |
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in human clinical trials evaluating an artificial coronary bypass graft |
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Use of $26.7mm in IPO proceeds from sale of 5.5mm shares |
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• 20% to fund our clinical trials; |
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• 15% to fund our investigation of drug combination and coating technologies; |
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• 35% to develop our sales and marketing capabilities, promote pre- and post-commercialization |
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physician education and awareness, and create product marketing programs, an international |
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distribution network and a domestic sales team; and |
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• 30% for general corporate purposes, including working capital needs, facilities expansion and |
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potential acquisitions. |
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===================================== |
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Dec 8 |
OccuLogix (RHEO) |
RHEO, 2-Stars, C |
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innovative treatments for eye diseases |
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Post-IPO:41.76mm shrs |
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Mississauga, Ontario CA |
2002 |
2003 |
Sept 9 mos |
IPO Mkt |
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Revenue (mm) ($) |
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$0.1 |
$0.5 |
$0.5 |
Cap (mm) |
|
|
Gross margin % |
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72.2% |
26.5% |
31.6% |
$376 |
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Operating Income % |
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6.4% |
6.4% |
11.7% |
@$9 |
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Income (loss) ($) |
-$4.0 |
-$2.9 |
-$19.7 |
-$4.5 |
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Income (loss) (%) |
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-4833.3% |
-4053.5% |
-993.4% |
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2003 results includes $15.9mm of stock option expense |
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VALUATION RATIOS |
IPO Mrkt |
Price / |
Price / |
Price / |
Price / |
% offered |
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Cap (mm) |
Sales |
Earnings |
BookValue |
TangibleBV |
in IPO |
|
Dec 8 |
OccuLogix (RHEO) |
376 |
622.3 |
63 |
1.7 |
8.0 |
20% |
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SCORECARD |
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Mgt |
Market |
Market Do- |
Proprie- |
Total |
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1-5, 5 is high |
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Growth |
mination |
tary |
rating |
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20 is perfect |
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2 |
2 |
0 |
2 |
6 |
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Business |
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. Ophthalmic therapeutic company founded to commercialize innovative treatments for eye |
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diseases, including age-related macular degeneration, or AMD. |
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. AMD is the leading cause of late onset visual impairment and legal blindness in people over the |
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age of 50 in the United States and other Western industrialized societies. |
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Market potential |
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. RHEO believes that 15 million people in the United States suffer from AMD. |
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. According to a ten-year study published in Ophthalmology in October 2002, the prevalence of |
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AMD among a select sample of U.S. residents increased sharply with age, from 28.2% among |
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people 65 to 74 years of age to 46.2% among people 75 years and older. |
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. A study by Duke University published in 2003 reported that the prevalence of AMD among a |
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selected sample of U.S. residents aged 65 and older was 27% in 1999. |
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. According to the U.S. Census Bureau, the number of people in the United States aged 50 or older |
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is 80 million and is expected to increase by 40% over the next two decades. |
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. RHEO expects that this increase in the number of elderly people will result in a significant |
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increase in the number of cases of AMD in the United States. |
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Market Opportunity |
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. RHEO believes that Dry AMD, the most common form of the disease, afflicts 13.0 to 13.5 |
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million people in the United States, representing 85% to 90% of all AMD cases. |
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. Although the exact cause of AMD is not known, researchers have identified several factors that |
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are associated with AMD, including poor microcirculation and the gradual build-up of cellular |
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waste material in the retina. |
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. RHEO believes that a treatment that improves microcirculation in the retina can help to enhance |
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the metabolic efficiency of the retina and the removal of waste material and thereby aid in the |
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treatment of Dry AMD. |
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. RHEO believes there is a significant market opportunity for such a treatment. |
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Overview of AMD |
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. AMD is a chronic, progressive disease of the macula, or the central part of the retina, that results |
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in the loss of central vision, and cannot be corrected by refractive means, such as glasses, contact |
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lenses or laser eye surgery. |
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. Dry AMD is characterized by a gradual decrease of visual acuity, pigment abnormalities on the |
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macula and the build-up of protein and lipid deposits, called drusen. |
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. This build-up of drusen affects the microcirculation in the eye. Research suggests that the retinal |
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cells, overwhelmed by the lack of oxygen and nutrients and the build-up of debris, enter into a |
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dysfunctional state. |
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. Without treatment, the retinal cells ultimately die and do not regenerate, leading to irreversible |
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vision loss either through the progression of Dry AMD or conversion into Wet AMD, the other |
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form of the disease. |
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No current cure for Wet AMD |
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. Retinal specialists may treat the symptoms of Wet AMD using one of a very few FDA-approved |
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therapies currently available, including thermal laser treatment and photodynamic therapy. |
|
. There are currently more than 30 therapies being evaluated in U.S. clinical studies for the |
|
treatment of Wet AMD. |
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. These treatments may slow the progression of the disease, but do not prevent the reoccurrence of |
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abnormal blood vessel growth and do not restore lost vision. |
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|
|
. The only currently accepted treatment option for persons with advanced cases of Dry AMD is to |
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take over-the-counter vitamins, antioxidants and zinc supplements which can reduce, but do not |
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eliminate, the risk of conversion to Wet AMD. |
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|
|
|
. According to the Age Related Eye Disease Report, or AREDS Report, No. 11, vitamins, |
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antioxidants and zinc supplements only reduce the five-year risk of conversion into Wet AMD by |
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up to 25% for Category 3 and Category 4, intermediate-to-late stage, Dry AMD cases. Regardless |
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of the supplement treatments, Dry AMD may ultimately lead to irreversible vision loss, whether or |
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not it converts into Wet AMD. |
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Product |
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. RHEO's product, the RHEO System, is designed to improve microcirculation in the eye by |
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filtering high molecular weight proteins and other macromolecules from the patient’s plasma. |
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. The RHEO System is used to perform Rheopheresis, which we refer to under our trade name |
|
RHEO Therapy. Rheopheresis is a blood filtration process that selectively removes molecules |
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from plasma. |
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. The RHEO System consists of the OctoNova pump and a disposable treatment set, containing |
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two filters, through which the patient’s blood circulates. We believe that the RHEO System is the |
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only Dry AMD treatment to target what we believe to be the underlying cause of AMD rather than |
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its symptoms and that, based on preliminary data, appears to demonstrate improved vision in some |
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patients. |
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RHEO Solution |
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. The RHEO System, which consists of a pump and a disposable treatment set, containing two |
|
filters, is designed to filter high molecular weight proteins and other macromolecules from the |
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patient’s plasma and improve microcirculatory function. |
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|
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. The RHEO System pumps blood from a large vein in one arm and circulates the blood through a |
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filtration system that separates the whole blood from the plasma. |
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|
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. The patient’s plasma is filtered to remove high molecular weight proteins and other |
|
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macromolecules. |
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. The filtered plasma is then remixed with the whole blood and returned to the patient |
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intravenously through the other arm. RHEO's believes that blood filtered with the RHEO System |
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is able to flow more easily through the tiny capillaries of the eye and that the resulting improved |
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microcirculation more effectively supplies the macular cells with oxygen and nutrients, facilitating |
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removal of cellular waste materials |
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North American & Caribbean rights |
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. RHEO has exclusive rights to commercialize the RHEO System for ophthalmic uses in North |
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America and the Caribbean. |
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RHEO does not have rights to commercialize the RHEO System in Europe |
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Related party |
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. RHEO's primary customer is RHEO Clinic Inc., a subsidiary of TLC Vision |
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Relationship with TLC Vision |
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. TLC Vision, after this offering, will beneficially own 52.2% of RHEO outstanding common |
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stock, or 48.9% on a fully diluted basis. |
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|
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. Elias Vamvakas, the Chairman and former CEO of TLC Vision, became RHEO's Chairman in |
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2003 and is now also RHEO's CEO |
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Commercialization |
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. In 2003, began limited commercialization of the RHEO System in three clinics in Canada. |
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. In September 2004, signed an agreement with Rheo Therapeutics Inc., a private Canadian |
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company, which has agreed to purchase 8,000 treatment sets, and an estimated 20 OctoNova |
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pumps by the end of 2005, with an option to purchase up to an additional 2,000 treatment sets, |
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subject to availability. |
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. RHEO believes that Rheo Therapeutics plans to open a number of commercial treatment centers |
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in various Canadian cities where RHEO Therapy will be performed |
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FDA |
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|
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|
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. The RHEO System is a class III device and will require approval of a PMA, which has not yet |
|
been submitted to the FDA |
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Clinical trial |
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. RHEO is currently conducting a pivotal clinical trial, called MIRA-1, which, if successful, is |
|
expected to support RHEO's application with the U.S. Food and Drug Administration, or FDA, |
|
to obtain approval to market the RHEO System in the United States |
|
|
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Patents and Proprietary Rights |
|
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|
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. There is currently no FDA-approved therapy for Dry AMD and, to date, RHEO is not aware of |
|
any other treatment in clinical development in North America. |
|
|
|
. One aspect of the RHEO System is a treatment method described in an issued U.S. patent which |
|
expires in 2017. This patent, issued under U.S. patent number 6,245,038 and entitled "Method of |
|
Treatment of Ophthalmological Diseases," is directed to a process for treating ocular diseases |
|
using apheresis. RHEO licenses this patent from the two co-owners of the patent under a separate |
|
license agreement with each owner. Under the license agreements, RHEO has the exclusive right |
|
to use the claimed treatment method in the U.S. during the term of the patent. As part of those |
|
agreements RHEO is required to make royalty payments in the aggregate of 2% of the sales for the |
|
OctoNova pumps and filters, subject to minimum required payments in the aggregate amount of |
|
$25,000 during each calendar quarter. |
|
|
|
|
|
. In addition, RHEO owns one issued patent in the United States, which expires in 2019. This |
|
patent, issued under U.S. patent number 6,551,266 and entitled "Rheological Treatment Methods," |
|
is directed to methods of screening and identifying patient candidates for RHEO Therapy. |
|
. RHEO also has three additional pending patent applications in the United States, Europe and |
|
Japan relating to the 6,551,266 patent. |
|
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|
|
Competition |
|
|
|
|
|
|
|
. RHEO specifically targets those afflicted with Dry AMD. |
|
|
|
|
. While RHEO is aware that a number of companies have developed or are in the process of |
|
developing treatments for Wet AMD, including Eyetech Pharmaceuticals, Inc./ Pfizer Inc., |
|
Genentech, Inc./ Novartis Ophthalmics, Alcon Laboratories, Inc., Iridex Corporation, QLT Inc. |
|
and Gen Vec, Inc., |
|
|
|
|
|
|
|
. RHEO is not aware of any companies developing treatments specifically for Dry AMD |
|
|
. However, some of these companies may develop new treatments for Dry AMD or may develop |
|
modifications to their treatments for Wet AMD that may be effective for Dry AMD as well |
|
|
. While there are other suppliers who manufacture a pump that could be used in the RHEO |
|
System, there are no other suppliers of Asahi’s Rheofilter and consequently RHEO believes that a |
|
third party could not readily make a system similar to the RHEO System. |
|
|
. Furthermore, if a third party were to be successful in making a system similar to the RHEO |
|
System, it would be required to have that system approved for marketing in the United States by |
|
the FDA. |
|
|
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|
|
|
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Use of $44.8mm in IPO proceeds from sale of 5.6mm shares |
|
|
|
(selling shareholders intend to offer 2.8mm shares) |
|
|
|
|
. $5.3 to $6.6mm to complete our MIRA-1 trial, a related crossover trial and additional anticipated |
|
clinical trials and complete the FDA approval process. |
|
|
|
|
. $17.5mm to $18.8mm to build our infrastructure, including distribution, sales and marketing, and |
|
to facilitate the commercialization of the RHEO System if and when FDA approval is received |
|
. RHEO estimates that infrastructure growth will result in increased employee related costs of |
|
$11.0 million to $11.5 million, with related travel and administrative costs of $4.7 million to $5.0 |
|
million |
|
|
|
|
|
|
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. $9.5mm to $10.5mm to purchase and accumulate inventory of components of the RHEO System |
|
to facilitate rapid commercialization in the United States if and when FDA approval is received |
|
=================================== |
|
|
|
|
|
Dec 9 |
SYMMETRY Medical |
SMA, 2-Stars, C+ |
|
|
|
|
|
implants, elated instruments & cases for orthopedic device manufacturers. |
Post-IPO: 32.8mm shrs |
|
Warsaw, Indiana |
2001 |
2002 |
2003 |
Sept 9 mos |
IPO Mkt |
|
|
Revenue (mm) ($) |
$66.5 |
$65.4 |
$158.4 |
$153.1 |
Cap (mm) |
|
|
Gross margin % |
27.5% |
26.8% |
29.0% |
29.2% |
$459 |
|
|
Operating Income % |
11.7% |
12.4% |
14.2% |
18.1% |
@$14 |
|
|
Income (loss) ($) |
$5.0 |
$5.0 |
$5.0 |
$11.0 |
|
|
|
Income (loss) (%) |
7.5% |
7.6% |
3.2% |
7.2% |
|
|
|
2003 and Sept 9 months are proforma and include the Mettis acquisition (see below) |
|
|
VALUATION RATIOS |
IPO Mrkt |
Price / |
Price / |
Price / |
Price / |
% offered |
|
|
Cap (mm) |
Sales |
Earnings |
BookValue |
TangibleBV |
in IPO |
|
Dec 9 |
SYMMETRY Md SMA |
459 |
2.2 |
31 |
2.5 |
11.0 |
24% |
|
SCORECARD |
|
Mgt |
Market |
Market Do- |
Proprie- |
Total |
|
1-5, 5 is high |
|
|
Growth |
mination |
tary |
rating |
|
20 is perfect |
|
2 |
2 |
2 |
2 |
8 |
|
Business |
|
|
|
|
|
|
|
. The world’s largest independent provider of implants and related instruments and cases |
|
to orthopedic device manufacturers |
|
|
|
|
|
|
. Orthopedic devices principally consist of reconstructive implants used to replace or repair knees, |
|
hips, shoulders and other joints, as well as other orthopedic devices to repair bone fractures and |
|
the spine. |
|
|
|
|
|
|
|
Market Opportunity |
|
|
|
|
|
|
|
. The global medical device market was estimated to be approximately $207 billion in 2003. |
|
. The orthopedic device segment of the medical device market was estimated to be approximately |
|
$16 billion in 2003, and is expected to grow approximately 12% annually to greater than $25 |
|
billion by 2007. |
|
|
|
|
|
|
|
. There were approximately 1.5 million reconstructive orthopedic implant procedures performed |
|
globally in 2003, an increase of 13% over the previous year. |
|
|
|
|
Market growth drivers |
|
|
|
|
|
|
|
. Growing elderly population; aging, |
|
|
|
|
|
|
. Affluent and active "baby boomers"; |
|
|
|
|
|
. Improving technologies that expand the market, including minimally invasive surgery; |
|
|
. Developing international markets. |
|
|
|
|
|
|
Mettis acquisition |
|
|
|
|
|
|
|
. SMA acquired Mettis on June 11, 2003 for $164mm |
|
|
|
|
. Mettis is a leading manufacturer of forged, cast and machined implants for global orthopedic |
|
device manufacturers. This acquisition added implants to our product offerings and increased |
|
SMA's European presence. |
|
|
|
|
|
|
. SMA now offers a comprehensive line of implants, surgical instruments and cases for orthopedic |
|
device manufacturers on a global basis |
|
|
|
|
|
Customers |
|
|
|
|
|
|
|
. During fiscal 2003, SMA sold to 500 customers, including 72 new customers. |
|
|
. Four largest customers accounted for 22.6%, 15.2%, 14.7% and 10.3% of revenue in the nine |
|
months ended October 2, 2004 |
|
|
|
|
|
|
. Three largest customers accounted for 19.5%, 14.7% and 10.5% of revenue in fiscal 2003. |
|
. Ten largest customers collectively accounted for 77.7% and 68.3% of revenue in the nine months |
|
ended October 2, 2004 and fiscal 2003, respectively. |
|
|
|
|
. 67.6%, 12.5% and 19.9% of revenue in the nine months ended October 2, 2004 was from sales to |
|
customers in the United States, United Kingdom and other foreign countries, respectively. |
|
. Customer base includes Biomet Inc., DePuy Inc., Kyocera Corporation, Medtronic Sofamor |
|
Danek, Smith & Nephew plc, Stryker Corporation, Synthes, Inc. and Zimmer Holdings, Inc. |
|
Competition |
|
|
|
|
|
|
|
. SMA believes one or more of its customers may seek to expand their development and |
|
manufacturing operations which may reduce their reliance on independent suppliers such |
|
as SMA |
|
|
|
|
|
|
|
. SMA is not aware of any medical device manufacturers who currently sell products |
|
|
similar to the ones SMA produces to third parties |
|
|
|
|
|
. SMA believes that it is the only independent supplier to offer a complete implant, |
|
|
instrument and case solution to orthopedic device manufacturers. |
|
|
|
. The majority of the competition are privately owned and produce some, but not all, of the |
|
products required in orthopedic implant systems. |
|
|
|
|
Olympus Partners -- controlling shareholder |
|
|
|
|
|
. Olympus Partners, a private asset management firm headquartered in Stamford, CT Connecticut, |
|
with assets under management of approximately $1.7 billion. Through its . Prior to the offering, |
|
the Olympus funds beneficially owned an aggregate of 82.1% of SMA's our common stock |
|
Use of $97.7mm in IPO proceeds |
|
|
|
|
|
|
. $36.4 to repay all of existing subordinated indebtedness, of which $8.0 million is held by |
|
the Olympus funds (the majority owner) |
|
|
|
|
|
. $45 million to repay a portion of existing senior indebtedness. |
|
|
|
. $16.2 million to repurchase a portion of outstanding preferred stock and preferred stock |
|
|
warrants, 92% of which are held by SMA's affiliates |
|
|
|
|
=================================== |
|
|
|
|
|
VNUS Medical |
VNUS, 2-Stars, C+ |
|
|
|
|
|
medical devices for minimally invasive treatment of venous reflux disease |
|
|
San Jose, CA |
2001 |
2002 |
2003 |
June 6mos |
IPO Mkt |
Price / |
|
Revenue (mm) ($) |
$5.6 |
$10.0 |
$21.8 |
$16.9 |
Cap (mm) |
Sales |
|
Gross Margin % |
41% |
64% |
72% |
76% |
$192 |
|
|
Sales & Marketing % |
101% |
77% |
55% |
44% |
@$14 |
|
|
Income (loss) ($) |
-$8.5 |
-$6.0 |
-$2.6 |
$0.9 |
|
|
|
Income (loss) % |
-152% |
-60% |
-12% |
5% |
|
|
|
VALUATION RATIOS |
IPO Mrkt |
Price / |
Price / |
Price / |
Price / |
% offered |
|
|
Cap (mm) |
Sales |
Earnings |
BookValue |
TangibleBV |
in IPO |
|
Oct 20 |
VNUS Medical (VNUS) |
192 |
5.6 |
112 |
3.4 |
3.4 |
35% |
|
SCORECARD |
|
Mgt |
Market |
Market Do- |
Proprie- |
Total |
|
1-5, 5 is high |
|
|
Growth |
mination |
tary |
rating |
|
20 is perfect |
|
2 |
2 |
2 |
1 |
7 |
|
Business |
|
|
|
|
|
|
|
. Medical devices for the minimally invasive treatment of venous reflux disease. |
|
|
. Venous reflux disease, a progressive condition caused by incompetent vein valves, is |
|
|
characterized by the poor return of blood from the legs to the heart. |
|
|
|
. This results in symptoms that significantly impact quality of life such as leg pain, swelling, |
|
Recently profitable |
|
|
|
|
|
|
|
. In the last quarter of 2003 and each of the first two quarters of 2004 VNUS was profitable. |
|
. In the first six months of 2004, VNUS shipped products to 549 customers in the United States |
|
compared to 328 customers during the same period in 2003 |
|
|
|
|
Products |
|
|
|
|
|
|
|
. The Closure system, which consists of a proprietary radio-frequency, or RF, generator and |
|
proprietary disposable endovenous catheters |
|
|
|
|
|
. Which close diseased veins through the application of temperature-controlled RF energy. |
|
. Product line: disposable catheters, RF generators and accessories |
|
|
|
. % of 2004 six month sales: disposable catheters 75%; RF generators 21%; accessories 4% |
|
Note: notice the high percentage of recurring revenue from disposables. |
|
|
|
Benefits |
|
|
|
|
|
|
|
. VNUS's Closure system provides the benefits of a minimally invasive procedure, with short |
|
recovery time and minimal post-operative pain |
|
|
|
|
|
. In a randomized clinical trial was established to be as effective as vein stripping, with fewer side |
|
effects and faster recovery. |
|
|
|
|
|
|
. Vein stripping is an open surgical procedure that has historically been the standard of care for |
|
venous reflux disease. |
|
|
|
|
|
|
|
Marketing & patients |
|
|
|
|
|
|
|
. The Closure system is marketed in the United States through VNUS's direct sales organization of |
|
44 people |
|
|
|
|
|
|
|
. The Closure procedure is accepted by the policies of 95 health insurers, representing over 200 |
|
million covered lives in the United States. |
|
|
|
|
|
. VNUS estimates that in excess of 60,000 patients have been treated using the Closure system |
|
since 1999 |
|
|
|
|
|
|
|
. With 18,000 of those patients treated in the first half of 2004. |
|
|
|
Market and Current Treatments |
|
|
|
|
|
|
. Published population studies indicate that 25 million people in the United States and 40 million |
|
people in Western Europe suffer from symptomatic venous reflux disease and experience painful |
|
symptoms. |
|
|
|
|
|
|
|
. Due to the pain and discomfort of the condition, venous reflux disease can be disabling and have |
|
a significant impact on quality of life by disrupting physical, social and professional activities. |
|
. VNUS commissioned a study that estimated that 1.2 million people in the United States with |
|
symptomatic venous reflux disease seek treatment each year, of which over 800,000 exhibit |
|
saphenous vein reflux and the attendant symptoms. |
|
|
|
|
. VNUS believes these 800,000 patients are eligible for treatment with the Closure system |
|
. As more people become aware of minimally invasive alternatives to vein stripping, VNUS |
|
believes a larger percentage of the 25 million symptomatic patients in the United States will seek |
|
therapy. |
|
|
|
|
|
|
|
Alternatives to vein stripping |
|
|
|
|
|
|
. Closure procedure and endovenous laser ablation, or EVL, have been developed as alternatives to |
|
vein stripping. |
|
|
|
|
|
|
|
. EVL is a medical procedure in which an optical fiber is inserted into the treated vein to deliver |
|
laser energy to boil blood, damage the vein and create a clot that occludes the length of the treated |
|
vein. |
|
|
|
|
|
|
|
. Currently marketed EVL technologies do not provide physicians feedback on the heat energy |
|
delivered during the procedure and, as a result, therapy is difficult to control and can cause vein |
|
perforation, bruising and pain. |
|
|
|
|
|
|
. VNUS believes that its Closure system results in less bruising and skin discoloration than vein |
|
stripping or EVL. Also, because the Closure procedure is catheter-based, it results in little or no |
|
scarring compared to vein stripping. |
|
|
|
|
|
|
Customers |
|
|
|
|
|
|
|
. Diverse customer base of hospitals, physicians and physician groups, with no customers |
|
accounting for 10% or more of net revenues in the years ended December 31, 2001, 2002 and |
|
'2003 or the first six months of 2004. |
|
|
|
|
|
. VNUS customers are reimbursed by governmental and third-party payors, and that |
|
|
reimbursement is subject to periodic review and adjustment. |
|
|
|
|
Patents and Proprietary Technology |
|
|
|
|
|
|
In the United States, as of September 15, 2004, VNUS had 29 issued patents and 15 pending |
|
patent applications |
|
|
|
|
|
|
|
. Many of which relate to the Closure system and procedure, including, among other things, vein |
|
shrinkage and occlusion using various forms of energy, including RF; self expanding and |
|
|
collapsing electrodes; and use of single and double electrode array devices. |
|
|
. Fourteen of the issued patents relate to devices or devices with methods and 15 relate to methods. |
|
. Issued patents related to the Closure system and procedure will expire between 2016 and 2018 |
|
. Internationally, as of September 15, 2004, VNUS has 8 foreign patents providing protection in |
|
Australia, New Zealand, Singapore, Russia, China and Europe. |
|
|
|
. In addition, VNUS has 29 pending foreign patent applications, many of which relate to the |
|
Closure technology. There are applications pending in Europe, Japan, Australia, Canada, New |
|
Zealand, Singapore, Russia and other countries. |
|
|
|
|
|
Competition |
|
|
|
|
|
|
|
. Principally competes against vein stripping procedures, as well as companies that have |
|
commercialized and sell EVL (endovenous laser ablation) systems. |
|
|
|
. Sclerotherapy and phlebectomy procedures that treat varicose veins at the surface of the skin are |
|
complementary to the Closure procedure because they do not treat saphenous vein reflux and may |
|
be used in conjunction with the Closure system. |
|
|
|
|
|
. Vein stripping and ligation surgery has historically been the standard of care to address venous |
|
reflux disease. This procedure is well established among physicians who treat venous reflux |
|
disease, has extensive long-term data, is routinely taught to new surgeons and has remained |
|
relatively unchanged for the past 50 years. |
|
|
|
|
|
EVL (endovenous laser ablation) competitors |
|
|
|
|
|
. Competitors that have developed and market EVL systems include AngioDynamics, Inc., biolitec |
|
AG, Diomed Holdings, Inc., Dornier MedTech GmbH and Vascular Solutions, Inc. |
|
|
. These competitors’ EVL systems use laser energy to occlude diseased veins by clotting the blood |
|
in the vein. |
|
|
|
|
|
|
|
Use of $41.4mm in IPO proceeds from sale of 3.3mm shares |
|
|
|
(shareholders plan to sell 1.4mm shares) |
|
|
|
|
|
• $10.0 million for sales and marketing activities; |
|
|
|
|
|
• $6.0 million for clinical research and product development; and |
|
|
|
• Remainder for working capital and other general corporate purposes |
|
|
|
=================================== |
|
|
|
|
|
CoTherix (CTRX) |
CTRX, 1-star, C |
|
|
|
|
|
biopharmaceutical: therapeutics for life threatening diseases. |
|
|
|
So San Francisco, CA |
2001 |
2002 |
2003 |
June 6 mos |
IPO Mkt |
Price / |
|
Grant Revenue |
0.0 |
0.0 |
0.2 |
none |
Cap (mm) |
Sales |
|
R&D |
2.3 |
3.4 |
2.8 |
8.5 |
$176 |
|
|
Income (loss) |
-2.9 |
-4.7 |
-12.6 |
-17.7 |
@$9 |
n/a |
|
VALUATION RATIOS |
IPO Mrkt |
Price / |
Price / |
Price / |
Price / |
% offered |
|
|
Cap (mm) |
Sales |
Earnings |
BookValue |
TangibleBV |
in IPO |
|
Oct 14 |
CoTherix (CTRX) |
176 |
n/a |
-5 |
2.4 |
2.4 |
26% |
|
SCORECARD |
|
Mgt |
Market |
Market Do- |
Proprie- |
Total |
|
1-5, 5 is high |
|
|
Growth |
mination |
tary |
rating |
|
20 is perfect |
|
2 |
2 |
0 |
2 |
6 |
|
Business |
|
|
|
|
|
|
|
. CTRX are a biopharmaceutical company focused on licensing, developing and commercializing |
|
therapeutic products |
|
|
|
|
|
|
|
. For the treatment of cardiopulmonary and other chronic diseases. |
|
|
|
Lead product |
|
|
|
|
|
|
|
. Ventavis, CTRX lead product candidate, is an inhaled formulation of iloprost. Iloprost is a |
|
synthetic compound that is structurally similar to prostacyclins, which are naturally-occurring |
|
molecules that cause blood vessels to dilate. |
|
|
|
|
|
. CTRX is developing Ventavis for the treatment of pulmonary arterial hypertension, or PAH, a |
|
highly debilitating disease characterized by severe constriction of the blood vessels of the lungs |
|
which leads to very high pulmonary arterial pressure. |
|
|
|
|
Schering AG License and Manufacturing Agreements |
|
|
|
|
. On October 2, 2003, CTRX entered into a development and license agreement with Schering |
|
AG. |
|
|
|
|
|
|
|
. This agreement grants us the exclusive right to develop and commercialize Ventavis in the U.S. |
|
for inhaled use for the treatment of pulmonary hypertension. |
|
|
|
|
. CTRX is obligated to use its best efforts to develop Ventavis in accordance with a mutually |
|
agreed upon development plan and to commercialize Ventavis in the U.S. |
|
|
|
Sales and Marketing |
|
|
|
|
|
|
|
. CTRX is currently building CTRX sales and marketing organization. |
|
|
|
. CTRX's plan is to develop CTRX own U.S. sales force and marketing infrastructure to |
|
|
commercialize Ventavis and other products that CTRX develop in the future. |
|
|
Competition |
|
|
|
|
|
|
|
CTRX face significant competition from pharmaceutical and biotechnology companies that are |
|
researching and developing products designed to treat cardiopulmonary and other chronic |
|
diseases. |
|
|
|
|
|
|
|
Use of $39mm in IPO proceeds |
|
|
|
|
|
|
. Up to $15.0 million to fund the commercialization of Ventavis, including establishing field-based |
|
clinical, physician education, and commercial capabilities and distribution arrangements to launch |
|
Ventavis; |
|
|
|
|
|
|
|
. Up to $8.0 million to fund clinical trials for Ventavis; and |
|
|
|
|
. $9.0 million milestone payment due to Schering AG under CTRX current licensing agreement |
|
upon NDA approval for Ventavis. |
|
|
|
|
|
|
=================================== |
|
|
|
|
|
IntraLase |
ILSE, 2-Stars, B- |
|
|
|
|
|
laser technology for the first step of LASIK surgery |
|
|
|
|
Irvine, CA |
2001 |
2002 |
2003 |
June 6mos |
IPO Mkt |
Price / |
|
Revenue (mm) ($) |
$1.8 |
$18.1 |
$25.4 |
$25.3 |
Cap (mm) |
Sales |
|
Gross Margin % |
3% |
27% |
33% |
40% |
$305 |
|
|
Income (loss) ($) |
-$15.7 |
-$11.9 |
-$11.9 |
-$4.0 |
@$12 |
6.0 |
|
Income (loss) % |
-872% |
-66% |
-47% |
-16% |
|
|
|
VALUATION RATIOS |
IPO Mrkt |
Price / |
Price / |
Price / |
Price / |
% offered |
|
|
Cap (mm) |
Sales |
Earnings |
BookValue |
TangibleBV |
in IPO |
|
Oct 7 |
IntraLase (ILSE) |
305 |
6.0 |
-38 |
3.5 |
3.5 |
26% |
|
SCORECARD |
|
Mgt |
Market |
Market Do- |
Proprie- |
Total |
|
1-5, 5 is high |
|
|
Growth |
mination |
tary |
rating |
|
20 is perfect |
|
2 |
2 |
2 |
2 |
8 |
|
Classic razor-razor blade (per procedure disposable) business model |
|
|
|
Business |
|
|
|
|
|
|
|
. Leading laser technology for the first step of LASIK surgery, the most common means of |
|
surgical vision correction. |
|
|
|
|
|
|
. Designs, developes and markets a laser, related software and disposable devices used |
|
|
to create a cut of tissue across the cornea of a patient's eye, or a corneal flap |
|
|
. The first step in LASIK surgery. |
|
|
|
|
|
|
Company vision |
|
|
|
|
|
|
|
. To replace the mechanical, metal-bladed microkeratome with the INTRALASE® FS |
|
|
laser in LASIK surgery practices. |
|
|
|
|
|
|
. Target the most active LASIK surgery practices in the United States and in key |
|
|
international markets to buy or lease the INTRALASE® FS laser |
|
|
|
. Generate repeat revenues from the sale of per procedure disposable patient interface. |
|
|
Benefits |
|
|
|
|
|
|
|
. ISLE's advanced laser technology improves the safety, precision and visual acuity of |
|
|
LASIK surgery by providing a computer-controlled laser solution as an alternative |
|
|
. To the traditional method of creating the corneal flap using a hand-held mechanical, |
|
|
metal-bladed device called a microkeratome. |
|
|
|
|
|
. ISLE believes its product offering will become the new standard of care for corneal flap |
|
|
creation. |
|
|
|
|
|
|
|
Market Opportunity |
|
|
|
|
|
|
|
. Vision correction represents one of the largest medical markets in the United States |
|
|
. According to Market Scope, LLC, an independent source of market information on the |
|
|
surgical vision correction market, of the 156.5 million people in the United States who |
|
|
require vision correction, approximately 55.5 million people, or 111 million eyes, are |
|
|
eligible for surgical vision correction and have not yet been treated. |
|
|
|
. According to Market Scope, LASIK surgery represents 88% of all U.S. surgical vision |
|
|
corrections, with a total U.S. annual market size of approximately $2.4 billion in 2004 |
|
|
. This market is currently under-penetrated, with less than 7% of all eligible patients |
|
|
opting for LASIK surgery instead of conventional solutions such as eyeglasses or contact |
|
lenses. |
|
|
|
|
|
|
|
. Industry analysts expect the growth rate in LASIK procedures in 2004 to be |
|
|
approximately 12% in the United States and 10% internationally, with volume outside the |
|
United States concentrated in Europe and the Asia-Pacific region. |
|
|
|
Target markets |
|
|
|
|
|
|
|
According to Market Scope, there are approximately 4,100 LASIK surgery practices |
|
|
worldwide. |
|
|
|
|
|
|
|
. Of these surgery practices, ISLE's target customers are the 1,400 most active LASIK |
|
|
surgery practices in the United States and in key international markets, which perform |
|
|
over 50 LASIK procedures per month. |
|
|
|
|
|
. As of June 30, 2004, approximately 150 of these 1,400 LASIK surgery practices were |
|
|
IntraLase customers |
|
|
|
|
|
|
|
. Of the total number of U.S. LASIK procedures performed in the three months ended |
|
|
June 30, 2004, 14% were performed using ISLE's product offering to create the corneal |
|
|
flap. |
|
|
|
|
|
|
|
. ISLE believes the other approximately 86% of total procedures performed in this time |
|
|
period were performed using the traditional microkeratome (see competition, below) |
|
|
Products |
|
|
|
|
|
|
|
Introduced into the U.S. market in late 2001 |
|
|
|
|
|
INTRALASE® FS laser |
|
|
|
|
|
|
|
Patent-protected laser is an ultra-fast laser, generating ten thousand pulses per second |
|
|
to create a precise surgical incision below the surface of the cornea to create the corneal |
|
flap. |
|
|
|
|
|
|
|
IntraLASIK® software. |
|
|
|
|
|
|
|
Proprietary software directs the laser to create the corneal flap based on each patient's |
|
|
surgical parameters. |
|
|
|
|
|
|
|
Disposable patient interface |
|
|
|
|
|
|
Patent-protected disposable patient interface is required for each eye treated and serves |
|
|
as an interface between ISLE's laser and the patient's eye. |
|
|
|
|
Revenue sources |
|
|
|
|
|
|
|
. Primarily from the sale or lease of INTRALASE® FS laser and |
|
|
|
. The sale of per procedure disposable patient interface |
|
|
|
|
. 98% of equipment is sold |
|
|
|
|
|
|
Installed base |
|
|
|
|
|
|
|
. As of June 30, 2004, ISLE had sold or leased 123 lasers in the United States |
|
|
. 30 outside the United States, primarily in the Asia-Pacific region, Europe and the Middle |
|
East. |
|
|
|
|
|
|
|
Seasonality |
|
|
|
|
|
|
|
. Lasers. Sales and leases of our lasers seasonal. |
|
|
|
|
. The second and fourth calendar quarters are typically stronger than the first and third |
|
|
calendar quarters. |
|
|
|
|
|
|
|
Six month revenue increase |
|
|
|
|
|
|
. Revenue increase attributable to continued market acceptance of product offerings and |
|
expansion into international markets, primarily in the Asia-Pacific region, Europe and the |
|
Middle East, which ISLE began in the second half of 2003. |
|
|
|
|
Laser equipment increase |
|
|
|
|
|
|
. During the six months ended June 30, 2004, ISLE sold or leased 47 lasers and |
|
|
generated $13.1 million in revenues |
|
|
|
|
|
|
During the six months ended June 30, 2003, ISLE sold or leased 27 lasers and |
|
|
generated $4.5 million in revenues. |
|
|
|
|
|
|
Per procedure disposable sales increase |
|
|
|
|
|
. During the six months ended June 30, 2004, ISLE sold 89,516 per procedure |
|
|
disposable patient interfaces and generated $10.3 million in revenues |
|
|
|
. Up from 34,694 per procedure disposable patient interfaces for the six months ended |
|
|
June 30, 2003, which generated $3.7mm in revenue |
|
|
|
|
. Increase is attributable to an increased installed base of lasers |
|
|
|
. ISLE entered the six month period ended June 30, 2004 with approximately 2.5 times |
|
|
the installed base of lasers as compared to the same period in 2003. |
|
|
|
. ISLE expects sales of per procedure disposable patient interfaces to continue to |
|
|
increase as the installed base of lasers increases. |
|
|
|
|
Competition Creating the Corneal Flap |
|
|
|
|
|
Microkeratome companies |
|
|
|
|
|
|
. Bausch & Lomb, with approximately half of the U.S. microkeratome and blade market |
|
|
. Moria/Microtech, the second largest supplier of microkeratomes and blades in the U.S. |
|
market, Advanced Medical Optics and Nidek. |
|
|
|
|
|
. ILSE believes that these microkeratome manufacturers will continue to enhance and |
|
|
further develop microkeratomes to improve performance and accuracy to compete with |
|
|
ISLE's laser. |
|
|
|
|
|
|
|
. Microkeratomes are less expensive than ISLE's laser, although surgeons typically need |
|
to purchase more than one microkeratome machine because the machine must be |
|
|
serviced at the manufacturer's location. |
|
|
|
|
|
. In addition, competitors may offer microkeratome systems at a lower price, may in the |
|
|
future price their microkeratome systems as part of a bundle of products or services, |
|
|
including the excimer laser used in the second step of LASIK surgery, or may enhance or |
|
further develop products to improve performance and accuracy of their existing product to |
|
compete against ISLE |
|
|
|
|
|
|
|
Competition Against LASIK |
|
|
|
|
|
|
. Because ILSE's technology is used in the first step of the LASIK surgery, ISLE also |
|
|
competes against other vision correction technologies that bypass the need for the |
|
|
creation of the corneal flap. |
|
|
|
|
|
|
. LASIK competes with other treatments such as eyeglasses, contact lenses and other |
|
|
surgical techniques. |
|
|
|
|
|
|
|
. Such techniques include corneal inlays and epithelial flaps, which are currently in the |
|
|
early stages of development and do not have a significant presence in the market. |
|
|
Use of $68mm in IPO proceeds |
|
|
|
|
|
|
. $1.5 million repay amounts owed under ISLE's equipment advance facility. |
|
|
. $765,000 for the second installment of the purchase price to be paid to the University of |
|
Michigan for the purchase of a fully paid, royalty free, irrevocable and worldwide license |
|
|
from the University of Michigan |
|
|
|
|
|
|
. Balance of the net proceeds to support continued growth |
|
|
|
|
==================================== |
|
|
|
|
Theravance (THRX) |
THRX, 2-Stars, C |
|
|
|
|
|
biopharmaceutical company |
|
|
|
|
|
|
S. San Francisco, CA |
2001 |
2002 |
2003 |
June 6mos |
IPO Mkt |
Price / |
|
3rd party rev ($mm) |
none |
$0.2 |
$3.6 |
$3.6 |
Cap (mm) |
Sales |
|
R&D ($mm) |
54 |
67 |
62 |
39 |
$583 |
|
|
Income (loss) ($) |
-$64.9 |
-$79.2 |
-$70.6 |
-$51.2 |
@$14 |
81.0 |
|
Income (loss) % |
#VALUE! |
-50769% |
-1961% |
-1438% |
|
|
|
VALUATION RATIOS |
IPO Mrkt |
Price / |
Price / |
Price / |
Price / |
% offered |
|
|
Cap (mm) |
Sales |
Earnings |
BookValue |
TangibleBV |
in IPO |
|
Sept 28 |
Theravance (THRX) |
583 |
81.0 |
-6 |
2.9 |
3.6 |
12% |
|
SCORECARD |
|
Mgt |
Market |
Market Do- |
Proprie- |
Total |
|
1-5, 5 is high |
|
|
Growth |
mination |
tary |
rating |
|
20 is perfect |
|
2 |
2 |
0 |
2 |
6 |
|
Business |
|
|
|
|
|
|
|
. Biopharmaceutical company with a pipeline of product candidates that THRX |
|
|
discovered and expect to develop in collaboration with partners or on THRX's own. |
|
|
. In seven years of operation, four product candidates discovered by THRX have |
|
|
advanced into clinical trials, two of which are currently in Phase 2. |
|
|
|
. THRX has seven additional product candidates discovered by THRX in preclinical |
|
|
studies. |
|
|
|
|
|
|
|
Relationship with GlaxoSmithKline |
|
|
|
|
|
|
2002 Collaboration |
|
|
|
|
|
|
|
. In November 2002, THRX entered into a long-acting beta2 agonist (LABA) collaboration |
|
|
agreement with GlaxoSmithKline (GSK) to develop and commercialize product |
|
|
candidates for the treatment of asthma and chronic obstructive pulmonary disease |
|
|
(COPD). |
|
|
|
|
|
|
|
. LABAs are medicines that work by relaxing the muscles that line the airways, allowing |
|
|
the airways to expand and leading to relief and/or prevention of many of the symptoms of |
|
asthma and COPD. |
|
|
|
|
|
|
|
. These LABA product candidates are intended to be administered via inhalation once |
|
|
daily both as a single new medicine and as part of a new combination medicine with an |
|
|
inhaled corticosteroid. |
|
|
|
|
|
|
|
. Under the terms of the collaboration with GSK, each company contributed four LABA |
|
|
product candidates to the collaboration. |
|
|
|
|
|
. GSK is responsible for all development and commercialization costs associated with |
|
|
these eight product candidates and will pay THRX based upon its product candidates |
|
|
reaching clinical, regulatory and commercial milestones. |
|
|
|
|
2004 Strategic Alliance. |
|
|
|
|
|
|
. In March 2004, THRX entered into a strategic alliance with GSK whereby GSK received |
|
an option to license product candidates from all of our other current and future drug |
|
|
discovery and development programs initiated prior to September 1, 2007, on pre |
|
|
determined terms and on an exclusive, worldwide basis. |
|
|
|
|
. If GSK exercises its option to license any of THRX programs, THRX will receive an |
|
|
upfront payment, additional payments if future milestones are achieved and royalties on |
|
|
any future sale of medicines developed from these programs. |
|
|
|
. In addition, GSK would fund all of the development and commercialization costs for |
|
|
product candidates in such programs. |
|
|
|
|
|
GSK ownership |
|
|
|
|
|
|
|
. GSK currently owns all of THRX's Class A common stock, which represents |
|
|
approximately 19.7% of outstanding stock before the offering. |
|
|
|
. GSK's ownership of THRX's stock could increase to approximately 60% through the |
|
|
issuance by THRX to GSK of the number of shares of our common stock that THRX may |
|
be required to redeem from its stockholders |
|
|
|
|
|
THRX Programs |
|
|
|
|
|
|
|
. Seven programs focused on discovering and developing new medicines. Three of these |
|
|
programs have product candidates in Phase 1 or Phase 2 clinical trials: |
|
|
|
. Asthma and COPD: Long-Acting Beta2 Agonists (LABA). |
|
|
|
|
. Bacterial Infections. THRX's lead antibiotic product candidate, telavancin, is a rapidly |
|
|
bactericidal, injectable antibiotic. In January 2004, we completed a Phase 2 clinical trial in |
|
complicated skin and soft tissue infections comparing the clinical results of telavancin |
|
|
with current standard antibiotic therapy |
|
|
|
|
|
. Overactive Bladder (OAB). THRX's lead product candidate for OAB is TD-6301. We |
|
|
initiated the first Phase 1 clinical trial of TD-6301 in December 2003. THRX plans to |
|
|
initiate additional Phase 1 clinical trials in 2004. According to IMS Health, the market for |
|
|
medicines to treat OAB in the United States, Japan and Europe was approximately $1.5 |
|
|
billion in 2003. |
|
|
|
|
|
|
|
Competition |
|
|
|
|
|
|
|
. Telavancin. THRX anticipates that, if approved, telavancin will compete with |
|
|
vancomycin, a generic drug that is manufactured by a variety of companies, as well as |
|
|
other drugs targeted at Gram-positive bacterial infections. These include daptomycin |
|
|
(marketed by Cubist Pharmaceuticals), linezolid (marketed by Pfizer Inc) and |
|
|
quinupristin/dalfopristin (marketed by Sanofi-Aventis and King Pharmaceutical). In |
|
|
addition, dalbavancin (being developed by Vicuron Pharmaceuticals) and oritavancin |
|
|
(being developed by Intermune, Inc.) are in late-stage clinical trials and represent |
|
|
potential competition for telavancin. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
. GSK LABA Collaboration. THRX anticipates that, if approved, any product from THRX |
|
LABA collaboration with GSK will compete with a number of approved bronchodilator |
|
|
drugs and drug candidates under development that are designed to treat asthma and |
|
|
COPD. These include salmeterol and fluticisone (marketed by GSK), formoterol |
|
|
(marketed by Novartis and AstraZeneca), and tiotropium (marketed by Boehringer |
|
|
Ingelheim and Pfizer Inc). In addition, QAB 149 (being developed by Novartis) is in late |
|
|
stage clinical trials and represents potential competition for any product from our LABA |
|
|
collaboration. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
. Overactive Bladder. THRX anticipates that, if approved, TD-6301 would compete with |
|
|
tolterodine (marketed by Pfizer Inc), oxybutinin (marketed by Ortho-McNeil |
|
|
Pharmaceutical, Inc. and Watson Pharmaceuticals) and trospium (marketed by Indevus |
|
|
Pharmaceuticals, Inc.). In addition, darifenacin (being developed by Novartis) and |
|
|
solifenacin (being developed by Yamanouchi Pharmaceutical Co., Ltd.) are in late-stage |
|
|
clinical trials and represent potential competition for TD-6301. |
|
|
|
Use of $65mm in IPO proceeds |
|
|
|
|
|
|
. THRX expects to use the net IPO proceeds, and $20 million to $30 million of existing |
|
|
cash and cash equivalents, to fund Phase 3 clinical trials of telavancin. |
|
|
|
. THRX current plans to begin these trials by the end of 2004. |
|
|
|
========================== |
|
|
|
|
|
|
Cogent Systems |
COGT, 3-Stars, B- |
|
|
|
|
|
provider of Automated Fingerprint Identification Systems, or AFIS |
|
|
|
South Pasadena, CA |
2001 |
2002 |
2003 |
June 6mos |
IPO Mkt |
Price / |
|
Revenue (mm) |
$13.1 |
$16.4 |
$32.2 |
$32.5 |
Cap (mm) |
Sales |
|
Gross Margin % |
65% |
70% |
68% |
77% |
$741 |
|
|
Operating Inc % |
31% |
46% |
64% |
62% |
@$9.5 |
10.8 |
|
Income (loss) ($)* |
$0.1 |
$1.7 |
$5.6 |
$7.3 |
|
|
|
Income (loss) % |
1% |
10% |
17% |
22% |
|
|
|
*proforma with taxes, rather than subchapter S |
|
|
|
|
|
---------------------------------------------------- |
|
|
|
|
|
|
Quarterly results |
Sept 03 |
Dec 03 |
March 04 |
June 04 |
|
|
|
Revenue (mm) |
$3.0 |
$20.0 |
$15.4 |
$17.1 |
|
|
|
Gross Margin % |
60% |
71% |
79% |
75% |
|
|
|
Operating Inc % |
93% |
17% |
43% |
34% |
|
|
|
VALUATION RATIOS |
IPO Mrkt |
Price / |
Price / |
Price / |
Price / |
% offered |
|
|
Cap (mm) |
Sales |
Earnings |
BookValue |
TangibleBV |
in IPO |
|
Sept 23 |
Cogent Sys (COGT) |
741 |
10.8 |
49 |
5.9 |
5.9 |
23% |
|
SCORECARD |
|
Mgt |
Market |
Market Do- |
Proprie- |
Total |
|
1-5, 5 is high |
|
|
Growth |
mination |
tary |
rating |
|
20 is perfect |
|
2 |
2 |
2 |
2 |
8 |
|
Business |
|
|
|
|
|
|
|
. Provides Automated Fingerprint Identification Systems, or AFIS (biometric) solutions to |
|
governments, law enforcement agencies and other organizations worldwide |
|
|
. Utilizes advanced search algorithms together with optimized hardware, to achieve high |
|
|
performance levels that enable customers to deploy systems in high traffic areas where real-time |
|
authentication or identification is critical, while still maintaining high accuracy rates. |
|
|
. In business since 1990 |
|
|
|
|
|
|
Growth drivers |
|
|
|
|
|
|
|
. Recent legislation passed in the United States and in many foreign jurisdictions mandating the |
|
implementation of fingerprint systems at points of entry and exit such as the US-VISIT program |
|
. Increased government spending on the infrastructure for fingerprint biometrics as well as recent |
|
terrorist attacks |
|
|
|
|
|
|
|
Recent increase based on Department of Homeland Security orders |
|
|
|
. COGT experienced a significant increase in revenues and net income in the fourth quarter of |
|
2003 and the first six months of 2004 as the market for our AFIS and other fingerprint biometric |
|
solutions expanded primarily due to increased demand by the Department of Homeland Security |
|
(DHS) for COGT AFIS solutions |
|
|
|
|
|
|
. Especially for COGT's Live-ID AFIS solutions in connection with the implementation of the |
|
United States Visitor and Immigrant Status Indicator Technology, or US-VISIT, program. |
|
|
COGT Objective |
|
|
|
|
|
|
|
To become the leading provider of biometric solutions for governments, law enforcement agencies |
|
and other organizations worldwide. Key elements of our strategy to achieve this objective include: |
|
Biometrics defined |
|
|
|
|
|
|
|
. Biometrics is the automated use of unique physiological characteristics of individuals, such as |
|
fingerprints, palm prints, faces or irises, to authenticate or verify an individual’s identity. . |
|
Biometrics can be more accurate, convenient and cost-effective than traditional methodologies due |
|
to its reliance on unchanging, unique characteristics that cannot be lost, stolen, forged, shared or |
|
forgotten. |
|
|
|
|
|
|
|
. Of the various types of biometrics, fingerprints have been, and COGT believes will continue to |
|
be, the most widely used biometric because they are relatively simple to capture, are oftentimes |
|
left at crime scenes, are relatively non-intrusive and are supported by a standardized classification |
|
format. |
|
|
|
|
|
|
|
. In addition, databases of hundreds of millions of fingerprints are already in use by law |
|
|
enforcement agencies, government agencies and other organizations worldwide. |
|
|
From the Cogent website, http://www.cogentsystems.com/cogent/cogenthome.html |
|
|
. Cogent is the world's leading supplier of integrated systems solutions using biometrics for both |
|
government and commercial users. Cogent is the only provider of biometric information systems |
|
. That can accurately perform biometric comparisons |
|
|
|
|
. Using its Image Flow (patent pending) and its massively parallel processing Data Flow (patent |
|
pending) supercomputer technology |
|
|
|
|
|
. To provide high performance real-time identification and authentication for information systems. |
|
Marketing & customers |
|
|
|
|
|
|
|
. Markets solutions directly to end customers and indirectly as a subcontractor with other vendors |
|
to U.S. and international government organizations such as the U.S. Department of Homeland |
|
Security, or DHS, the U.S. Department of Justice, Federal Bureau of Investigations, or FBI, the |
|
Federal Bureau of Prisons, the European Commission, National Electoral Council in the Republic |
|
of Venezuela, the Chilean National Police, the Italian National Police, the U.K. police, and the |
|
Singapore National Police, state and local law enforcement and government agencies, such as the |
|
Los Angeles County Sheriff’s Department and the Los Angeles Police Department, the State of |
|
Connecticut and the Ohio Bureau of Criminal Investigation and Identification, and other |
|
|
organizations such as the National Association of Securities Dealers and Hewlett-Packard. |
|
. To date, COGT has served as the primary supplier of AFIS solutions for the United States Visitor |
|
and Immigrant Status Indicator Technology, or US-VISIT, program, an extensive effort by the |
|
DHS requiring the fingerprinting of visitors that enter and exit the United States through air, sea |
|
and land ports. |
|
|
|
|
|
|
|
Dependence on Department of Homeland Security |
|
|
|
|
. COGT anticipates that the DHS will continue to require more of PMA servers, live-scans and |
|
related equipment, services and software to satisfy the mandated rollout plan for US-VISIT |
|
. And that the DHS will continue to account for a substantial portion of revenues for the |
|
|
foreseeable future. |
|
|
|
|
|
|
|
Future demand |
|
|
|
|
|
|
|
. COGT does not have any long-term contracts with the DHS for the sale of products |
|
|
. Any delay or other change in the rollout of US-VISIT would cause revenues to fall short of |
|
expectations |
|
|
|
|
|
|
|
. Future sales to the DHS will depend upon the receipt of additional purchase orders from the |
|
DHS. |
|
|
|
|
|
|
|
. COGT also expects to experience increased demand from a number of other governments as they |
|
deploy AFIS solutions at points of entry and exit, including borders, seaports and airports. |
|
Sources of Revenue |
|
|
|
|
|
|
|
. Programmable Matching Accelerator, or PMA, servers and other AFIS equipment, including |
|
work stations and live-scans, bundled with proprietary software. |
|
|
|
. Also included in product revenues are fees generated from design and deployment of AFIS |
|
solutions. |
|
|
|
|
|
|
|
. Also generates maintenance revenues from maintenance contracts that are typically included with |
|
the sale of AFIS solutions. |
|
|
|
|
|
|
Customer concentration |
|
|
|
|
|
|
. In 2003 and for the six months ended June 30, 2004, COGT derived 64% and 79%, respectively, |
|
of revenues from a limited number of customers, including 59% and 64%, respectively, directly or |
|
indirectly from various agencies of the DHS. |
|
|
|
|
|
. In 2003 and for the six months ended June 30, 2004, COGT derived 75% and 74%, respectively, |
|
of revenues from the sale of our solutions either directly or indirectly to U.S. government entities |
|
pursuant to government contracts, |
|
|
|
|
|
|
. In 2003, COGT had four customers that individually accounted for more than 5% of revenues. |
|
Those four customers collectively accounted for 64% of revenues in 2003, of which 59% of our |
|
revenues was derived from sales directly or indirectly to various agencies of the DHS. |
|
|
. For the six months ended June 30, 2004, COGT had five customers that collectively accounted |
|
for 79% of revenues for that period, of which 64% was derived from sales directly or indirectly to |
|
various agencies of the DHS. |
|
|
|
|
|
|
. COGT's most significant customer since 1995 has been, and for the foreseeable future is |
|
expected to continue to be, the DHS and its predecessor entities. |
|
|
|
. COGT expects that sales under its contract with the DHS for the United States Visitor and |
|
Immigrant Status Indicator Technology, or US-VISIT, program will account for a majority of |
|
revenues in 2004. |
|
|
|
|
|
|
|
Backlog |
|
|
|
|
|
|
|
As of December 31, 2003 and 2002, COGT's total backlog was $47 million and $19.1 million, |
|
respectively. |
|
|
|
|
|
|
|
International |
|
|
|
|
|
|
|
. For the year ended December 31, 2003 and for the six months ended June 30, 2004, revenues |
|
outside of the Americas accounted for approximately 15.0% and 20.4%, respectively, of total |
|
revenues. |
|
|
|
|
|
|
|
. COGT currently have international operations, including offices in the United Kingdom, Austria, |
|
China and Taiwan. Our international revenues and operations are subject to a number of material |
|
risks, including, but not limited to: |
|
|
|
|
|
|
Accounting weakness |
|
|
|
|
|
|
|
. COGT's independent auditors have reported several material weaknesses in internal controls |
|
Quarterly fluctuations |
|
|
|
|
|
|
|
. COGT's financial results often vary significantly from quarter to quarter |
|
|
|
Gross margins |
|
|
|
|
|
|
|
. For the remainder of 2004 COGT believes gross margins are likely to decrease due to anticipated |
|
changes in product mix, which COGT expects to reflect a smaller proportion of PMA server |
|
shipments |
|
|
|
|
|
|
|
Intellectual Property |
|
|
|
|
|
|
|
. Core technology used in COGT's products and solutions is not the subject of any patent or |
|
copyright protection. |
|
|
|
|
|
|
|
. COGT relies on a portfolio of intellectual property rights, both foreign and domestic, including |
|
trade secrets, trademarks, contractual provisions, patent applications and licenses to protect its |
|
intellectual property. |
|
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. Two pending patent applications relate to our Data Flow and Information Fusion technology. |
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Competition |
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Includes |
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• Diversified technology providers, such as NEC, Sagem Morpho, Inc. (a wholly owned subsidiary |
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of Sagem) and Motorola, Inc. (through its Printrak International division) that offer integrated |
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AFIS solutions to government and law enforcement agencies; |
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• Companies that are AFIS component providers, such as Identix; |
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• Prime government contractors such as Northrop Grumman, that develop integrated information |
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technology products and services that include biometrics-related solutions that are frequently |
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delivered in partnership with diversified technology providers and biometrics-focused companies; |
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• Companies focused on other fingerprint biometrics solutions, such as BioScrypt and Dermalog. |
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• COGT offerings also compete with non-biometric technologies such as public key infrastructure |
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solutions, smart card security solutions and traditional key, card surveillance and password |
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systems. |
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Use of $157mm in IPO proceeds |
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. $67mm stockholder dividend (conversion from subchapter S) |
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. Balance for working capital and general corporate purposes |
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==================================== |
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Nephros (NEP) |
NEP, 1 star, C |
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development stage medical device and technology company |
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New York, New York |
2001 |
2002 |
2003 |
June6mos |
IPO Mkt |
Price / |
|
Revenue |
$0.3 |
none |
none |
none |
Cap (mm) |
Sales |
|
Income (loss) ($) |
-1.0 |
-2.4 |
-5.6 |
-3.7 |
$78 |
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|
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@$6.50 |
n/a |
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VALUATION RATIOS |
IPO Mrkt |
Price / |
Price / |
Price / |
Price / |
% offered |
|
|
Cap (mm) |
Sales |
Earnings |
BookValue |
TangibleBV |
in IPO |
|
Sept 14 |
Nephros (NEP) |
78 |
n/a |
-11 |
5.8 |
5.8 |
32% |
|
SCORECARD |
|
Mgt |
Market |
Market Do- |
Proprie- |
Total |
|
1-5, 5 is high |
|
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Growth |
mination |
tary |
rating |
|
20 is perfect |
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1 |
2 |
0 |
2 |
5 |
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Business |
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. NEP is a development stage medical device and technology company that was founded in 1997 |
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by health professionals, scientists and engineers affiliated with Columbia University |
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. To develop cost-effective, improved products and therapies for End Stage Renal Disease, or |
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ESRD, therapy |
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Competition |
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. The dialyzer and renal replacement therapy market is subject to intense competition |
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. NEPH expects to compete with other suppliers of ESRD therapies, supplies and services. |
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. Suppliers include Fresenius Medical Care AG, The Gambro Company and Baxter International |
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Inc., currently three of the primary machine manufacturers in hemodialysis. |
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. At present, Fresenius, Gambro and Baxter also manufacture HDF machines. |
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. Some of the competitors, including Fresenius and Gambro, manufacture their own products and |
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own dialysis clinics in the United States, the Target European Market and other regions of the |
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world |
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Use of Proceeds |
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Marketing & sales, clinical studies, capital expenditures, supplier settlement, preferred stock |
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dividends, working capital |
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=================================== |
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