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Financial Performance & Scoring -- © 2007 Gaskins IPO Desktop/IPOdesktop |
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Pre-IPO analysis, grading & scoring -- updated May 26 |
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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 |
Denominator |
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IPO market capitalization… |
Annualized Sales (based on recent results) |
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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 |
Denominator |
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IPO market cap |
Annualized Earnings (loss) from the last quarter |
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=================== |
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SEARCH BY COMPANY |
In your browser use 'Edit/Find' to search for companies |
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or ticker for analysis |
scheduled below |
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=================== |
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May 28wk week IPO schedule |
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VALUATION RATIOS |
IPO Mrkt |
Price / |
Price / |
Price / |
Price / |
% offered |
|
Cap (mm) |
Sales |
Earnings |
BookValue |
TangibleBV |
in IPO |
|
|
Amicus Thera (FOLD) |
$333 |
n/a |
-8 |
2.6 |
2.6 |
23% |
|
Clinical-stage pharmaceutical: C, 6 |
Post-IPO shrs: 22m |
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|
Jazz Pharma (JAZZ) |
$614 |
11.0 |
-8 |
2.9 |
5.5 |
24% |
|
neurological and psychiatric products: C, 6.5 |
Post-IPO shrs: 24.5m |
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|
LDK Solar (LDK) |
$2,704 |
9.3 |
28 |
5.4 |
5.4 |
17% |
|
multicrystalline wafers for solar cells: B-, 8 |
Post-IPO shrs: 104m |
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May 28wk financials, analysis, grading, scoring |
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Amicus Therapeutics |
FOLD, C, 6 |
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Clinical-stage pharmaceutical |
Post-IPO shrs: 22m |
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|
Cranbury, NJ |
2004 |
2005 |
2006* |
March, 07* |
IPO Mkt |
|
|
Profit (loss) $mm |
-$9 |
-$21 |
-$47 |
-$10 |
Cap (mm) |
|
|
*quarter ending March 31 |
$333 |
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|
@$15 |
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VALUATION RATIOS |
IPO Mrkt |
Price / |
Price / |
Price / |
Price / |
% offered |
|
Cap (mm) |
Sales |
Earnings |
BookValue |
TangibleBV |
in IPO |
|
|
Amicus Thera (FOLD) |
$333 |
n/a |
-8 |
2.6 |
2.6 |
23% |
|
SCORECARD |
Mgt |
Market |
Market Do- |
Proprie- |
Total |
|
|
1-5, 5 is high |
Growth |
mination |
tary |
rating |
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|
20 is perfect |
2 |
2 |
0 |
2 |
6 |
|
|
Note: very high cash burn rate, as inidcated by a P/E ration of -8 |
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|
Business |
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|
. Clinical-stage biopharmaceutical company focused on the discovery, development and commercialization |
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|
of novel small molecule, orally-administered drugs, known as pharmacological chaperones, for the |
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|
treatment of a range of human genetic diseases. |
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|
. Certain human diseases result from mutations in specific genes that, in many cases, lead to the production |
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|
of proteins with reduced stability. |
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|
Misfolded proteins |
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Proteins with such mutations may not fold into their correct three-dimensional shape and are generally |
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referred to as misfolded proteins. |
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|
. Misfolded proteins are often recognized by cells as having defects and, as a result, may be eliminated |
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|
prior to reaching their intended location in the cell. |
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. The reduced biological activity of these proteins leads to impaired cellular function and ultimately to |
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disease. |
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The FOLD approach |
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. To the treatment of human genetic diseases consists of using pharmacological chaperones that selectively |
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bind to the target protein, increasing the stability of the protein and helping it fold into the correct three |
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dimensional shape. |
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. This allows proper trafficking of the protein, thereby increasing protein activity, improving cellular |
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|
function and potentially reducing cell stress. |
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. Currently conducting Phase II clinical trials of Amigal for Fabry disease, Phase II clinical trials of Plicera |
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for Gaucher disease, and Phase I clinical trials of AT2220 for Pompe disease. |
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Competition |
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FOLD is not aware that any currently working to develop products that would directly compete with |
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FOLD's product pipeline. |
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. Major competitors include pharmaceutical and biotechnology companies in the United States and abroad |
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that have approved therapies or therapies in development for lysosomal storage disorders within FOLD's |
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core programs. |
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. Other competitors are pharmaceutical and biotechnology companies that have approved therapies or |
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therapies in development for genetic diseases for which pharmacological chaperone technology may be |
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|
applicable. |
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. Additionally, FOLD ise aware of several early-stage, niche pharmaceutical and biotechnology companies |
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|
whose core business revolves around protein misfolding |
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. Specific competitors include Genzyme Corporation, Shire PLC, Actelion, Ltd. |
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Use of $68mm in IPO proceeds |
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|
o $20.0 million for clinical development of Amigal for the treatment of Fabry disease; |
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o $20.0 million for clinical development of Plicera for the treatment of Gaucher disease; |
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o $20.0 million for clinical development of AT2220 for the treatment of Pompe disease; |
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o $5.0 million for research and development activities relating to additional preclinical programs |
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o the balance, if any, to fund working capital and other general corporate purposes, |
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=================== |
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Jazz Pharmaceuticals |
JAZZ, C, 6.5 |
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neurological and psychiatric products |
Post-IPO shrs: 24.5m |
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Palo Alto, CA |
2004 |
2005 |
2006 |
March, 06* |
March, 07* |
IPO Mkt |
|
Rev ($mm) |
$21 |
$45 |
$10 |
$14 |
Cap (mm) |
|
|
Direct product cost % |
20% |
16% |
16% |
14% |
$614 |
|
|
Operating loss % |
-366% |
-174% |
-196% |
-139% |
@$26 |
|
|
Profit (loss) $mm |
-$25 |
-$85 |
-$59 |
-$22.4 |
-$19.5 |
|
|
Profit (loss) % |
-397.2% |
-131.4% |
-228.6% |
-139.3% |
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|
*quarter ending March 31 |
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|
VALUATION RATIOS |
IPO Mrkt |
Price / |
Price / |
Price / |
Price / |
% offered |
|
Cap (mm) |
Sales |
Earnings |
BookValue |
TangibleBV |
in IPO |
|
|
Jazz Pharma (JAZZ) |
$614 |
11.0 |
-8 |
2.9 |
5.5 |
24% |
|
SCORECARD |
Mgt |
Market |
Market Do- |
Proprie- |
Total |
|
|
1-5, 5 is high |
Growth |
mination |
tary |
rating |
||
|
20 is perfect |
2 |
2 |
1 |
1.5 |
6.5 |
|
|
Comments |
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. Intellectual property position doesn't seem strong |
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. 57% of IPOproceeds to market a product in the US acqired in January 2007 |
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. Very high cash burn rate, as inidcated by a P/E ration of -8 |
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|
. Very interesting product portfolio |
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Business |
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Specialty pharmaceutical company focused on identifying, developing and commercializing innovative |
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products to meet unmet medical needs in neurology and psychiatry. |
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Summary -- $115mm of $158mm in proceeds |
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(most of remainder of IPO proceeds for R&D) |
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Luvox CR -- $90mm of IPO proceeds allocated to Luvox CR |
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|
> Acquired Luvox CR in January 2007 only in the U.S. |
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. Obtained the exclusive rights to market and distribute Luvox CR in the United States from Solvay |
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Pharmaceuticals, Inc., or Solvay, in January 2007. |
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|
. Solvay retains the rights to market and distribute Luvox CR outside of the United States. Solvay submitted |
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|
a new drug application, or NDA, to the FDA for Luvox CR in April 2006, and, in February 2007, the FDA |
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|
issued an approvable letter. |
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> JAZZ will need to demonstrate that the benefits of Luvox CR to patients justify the higher price of a |
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|
branded product. |
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> o Luvox CR (fluvoxamine maleate extended release capsules) is Luvox CR, an extended release |
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|
formulation of fluvoxamine, a selective serotonin reuptake inhibitor, which has been developed for the |
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|
treatment of obsessive compulsive disorder and social anxiety disorder. |
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|
Phase III clinical trials -- $25mm of IPO proceeds |
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|
. JAZZ's only product candidate currently in Phase III clinical trials is JZP-6 for the treatment of |
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|
fibromyalgia syndrome. |
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|
. ThePhase III clinical program for JZP-6 is costly, and JAZZ does not expect to complete the program |
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|
until early 2009. |
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Intellectual property - doesn't seem strong |
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|
Has filed multiple U.S. patent applications and foreign counterparts |
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|
Patent Risk: |
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|
. The pharmaceutical and life sciences industry has produced a proliferation of patents, and it is not always |
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|
clear to industry participants, including JAZZ, which patents cover various types of products or methods. |
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|
. The coverage of patents is subject to interpretation by the courts, and the interpretation is not always |
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|
uniform |
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The existence of a patent will not necessarily prevent other companies from developing similar or
therapeutically equivalent products or protect us from claims of third parties that our products infringe their
issued patents, which may require licensing and the payment of significant fees or royalties.
Competitors may successfully challenge our patents, produce similar products that do not infringe our |
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patents, or manufacture products in countries where we have not applied for patent protection or that do not |
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respect our patents." |
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|
Formulations applied to known drug compounds |
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|
. Applies novel formulations and drug delivery technologies to known drug compounds, and compounds |
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|
with the same mechanism of action or similar chemical structure as marketed products, to improve patient |
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care by, among other things, improving efficacy, reducing adverse side effects or increasing patient |
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compliance relative to existing therapies. |
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|
. By working with these drug compounds, JAZZ believes that it can substantially mitigate the risks and |
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|
reduce the costs and time associated with product development and commercialization of |
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new therapies with significant market opportunities. |
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Portfolio progress |
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|
. Since inception in 2003, has built a commercial operation and assembled a portfolio of products and |
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|
product candidates that currently includes |
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. Two marketed products that generated net product sales of $41.9 million in 2006, |
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|
. One product candidate for which an approvable letter has been issued by the U.S. Food and Drug |
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|
Administration, or FDA, and |
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. Five product candidates in various stages of clinical development. |
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. Also has additional product candidates in earlier stages of development. |
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. In March 2007, sold rights to a third marketed product that generated net product sales of $1.4 million |
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in 2006 for cash consideration of $9.0 million. |
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JAZZ's marketed products in 2006 were: |
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o Xyrem (sodium oxybate) oral solution. Xyrem is the only product approved by the FDA for the |
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|
treatment of both cataplexy and excessive daytime sleepiness in patients with narcolepsy. Net product sales |
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|
of Xyrem were $29.0 million in 2006 and $8.6 million in the first quarter of 2007. We promote Xyrem in |
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|
the United States to neurologists, psychiatrists, pulmonologists and sleep specialists through our 55 person |
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specialty sales force. Xyrem is distributed in the United States by Express Scripts Specialty Distribution |
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|
Services, or Express Scripts, a specialty pharmaceutical distribution company, which is our only customer |
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|
for Xyrem. We have licensed the rights to commercialize Xyrem in 54 countries outside of the United |
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States to UCB Pharma Limited, or UCB, and in Canada to Valeant Canada Limited, or Valeant. In October |
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2005, the European Agency for the Evaluation of Medical Products approved Xyrem for the treatment of |
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|
cataplexy associated with narcolepsy and in March 2007, the European Agency for the Evaluation of |
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|
Medical Products approved the product for the treatment of narcolepsy with cataplexy in adult patients. |
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|
UCB has commercially launched Xyrem in 12 countries. |
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|
o Antizol (fomepizole). Antizol is the only FDA-approved antidote for suspected or confirmed ethylene |
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|
glycol or methanol poisonings in humans. We market Antizol primarily to hospitals and emergency rooms. |
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|
Net product sales of Antizol were $12.5 million in 2006 and $2.6 million in the first quarter of 2007. |
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Antizol is distributed to wholesalers in the United States, and we retain the services of a third party to |
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|
promote the product. Antizol is marketed by our distributors in Canada and Israel. We also market Antizol |
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|
Vet, an injectable formulation of fomepizole approved as an antidote for suspected or confirmed ethylene |
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|
glycol poisoning in dogs. Net product sales of Antizol-Vet in 2006 were $313,000. |
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|
o Cystadane (betaine anhydrous). Cystadane is approved by the FDA for the treatment of homocystinuria, |
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|
an inherited metabolic disease. Net product sales of Cystadane in 2006 were $1.4 million. In March 2007, |
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|
sold our rights to Cystadane to an unrelated third party for cash consideration of $9.0 million. |
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Late-stage product candidates |
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|
o Luvox CR (fluvoxamine maleate extended release capsules). |
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|
. Most advanced product candidate is Luvox CR, an extended release formulation of fluvoxamine, a |
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|
selective serotonin reuptake inhibitor, which has been developed for the treatment of obsessive compulsive |
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|
disorder and social anxiety disorder. |
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|
. Obtained the exclusive rights to market and distribute Luvox CR in the United States from Solvay |
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|
Pharmaceuticals, Inc., or Solvay, in January 2007. |
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|
. Solvay retains the rights to market and distribute Luvox CR outside of the United States. Solvay submitted |
||||||
|
a new drug application, or NDA, to the FDA for Luvox CR in April 2006, and, in February 2007, the FDA |
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|
issued an approvable letter. |
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|
. Under the agreement with Solvay, Solvay has primary responsibility for the NDA for Luvox CR and |
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|
communications with the FDA until after such time, if ever, as the FDA approves the NDA for Luvox CR |
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. Subject to the satisfaction of the requirements set forth in an approvable letter issued by the FDA to |
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Solvay and FDA approval, JAZZ expects to commence promotion of Luvox CR in the United States in the |
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first quarter of 2008 through an expanded specialty sales force. |
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. During 2007, expects to make significant expenditures relating to the planned launch and |
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commercialization of Luvox CR, including milestone payments to Solvay, activities related to preparation |
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for marketing and promotion, expansion of the specialty sales force and production of commercial |
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quantities of Luvox CR. |
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o JZP-6 (sodium oxybate). |
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. Developing a liquid dosage form of sodium oxybate, the active pharmaceutical ingredient in Xyrem, for |
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the treatment of fibromyalgia syndrome. |
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|
. Has successfully completed a Phase II clinical trial of this product candidate for the treatment of |
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fibromyalgia syndrome. |
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. Currently conducting two pivotal Phase III clinical trials, and expects preliminary data from the first |
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Phase III pivotal clinical trial in the second half of 2008. |
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. Has granted to UCB the commercialization rights to JZP-6 in 54 countries outside of the United States. |
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Clinical development pipeline |
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In addition to product candidates in late-stage development, JAZZ's clinical development pipeline consists |
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of the following product candidates: |
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o JZP-4 (Type IIa sodium channel antagonist). |
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. Subject to the results of a proof of concept clinical trial, formulation studies and long-term toxicology |
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studies, plans to commence a Phase II clinical trial of JZP-4 for the treatment of epilepsy in the fourth |
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quarter of 2007. |
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. Also developing JZP-4 for the treatment of bipolar disorder. |
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o JZP-8 (benzodiazepine) |
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Plans to commence a Phase II clinical trial of JZP-8 for the treatment of acute repetitive seizure clusters in |
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refractory epilepsy patients in the fourth quarter of 2007. |
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o JZP-7 (dopamine agonist) |
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Intends to conduct an additional pharmacokinetic study of JZP-7 in 2007 prior to commencing Phase II |
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clinical trials for the treatment of restless legs syndrome. |
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o JZP-2 (benzodiazepine) |
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Has developed a target formulation for JZP-2 and plan to commence one or more clinical trials of JZP-2 for |
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the acute treatment of panic attacks associated with panic disorder in 2007. |
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Funding by category |
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|
o Equity Financings. Preferred stock financings raised gross proceeds of $265.0 million. |
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o Debt Financings. In connection with the acquisition of Orphan Medical, issued $80.0 million aggregate |
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|
principal amount of senior secured notes and warrants to purchase 785,728 shares of Series BB convertible |
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preferred stock. Additionally, in September 2006, entered into a one year line of credit agreement with a |
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financial institution under which JAZZ may borrow up to 80% of eligible accounts receivable, up to a |
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maximum borrowing limit of $5.0 million. |
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o Development Financing. In August 2005, entered into an agreement with a third party under which the |
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|
third party agreed to provide $30.0 million to fund a Phase III clinical trial of JZP-3, a product candidate |
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|
then in development for the treatment of general anxiety disorder. Under that agreement, received $15.0 |
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|
million in 2005 and $15.0 million in 2006. In June 2006, following analysis of the results of the Phase III |
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|
clinical trial, notified the third party of our intention to discontinue development of the product candidate |
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|
and not to seek product marketing approval from the FDA. As a result of our notification, is not obligated |
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|
to make any payments to the third party that otherwise would have been made upon regulatory approval, |
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|
launch and commercialization of JZP-3. |
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|
o Collaboration. Under the terms of an agreement with UCB for Xyrem and JZP-6, received an upfront |
||||||
|
payment of $5.0 million and a $10.0 million payment upon election by UCB to exercise its rights to |
||||||
|
develop and commercialize JZP-6 for the treatment of fibromyalgia syndrome. Also entitled to additional |
||||||
|
development and commercialization milestone payments of up to $146.0 million and royalties on all |
||||||
|
commercial sales of Xyrem and JZP-6 by UCB. |
||||||
|
Financing history, chronology |
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|
. In March 2003, incorporated in the State of California and began operations. |
||||||
|
. In April 2003, we entered into agreements with investors for a $15.0 million Series A preferred stock |
||||||
|
financing, the funds from which were received in 2003 and early 2004. |
||||||
|
. In January 2004, we reincorporated in the State of Delaware. In February 2004, entered into agreements |
||||||
|
with investors for a $250.0 million Series B preferred stock and Series B Prime preferred stock financing |
||||||
|
led by an affiliate of Kohlberg Kravis Roberts & Co., the funds from which were received in 2004, 2005 |
||||||
|
and 2006. |
||||||
|
. On June 24, 2005, acquired Orphan Medical, Inc., including its three marketed products, Xyrem, Antizol |
||||||
|
and Cystadane, in order to complement the development portfolio with marketed products and to build |
||||||
|
JAZZ's commercial organization. |
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|
Competition |
||||||
|
Xyrem |
||||||
|
. As an alternative to Xyrem, cataplexy is often treated with tricyclic antidepressants and selective serotonin |
||||||
|
reuptake inhibitors, although none of these compounds has been approved by the FDA for the treatment of |
||||||
|
cataplexy. Tricyclic antidepressants are a class of antidepressant drugs first used in the 1950s. |
||||||
|
. The use of these drugs can often result in somnolence, which exacerbates excessive daytime sleepiness |
||||||
|
already experienced by all patients with narcolepsy. |
||||||
|
. Other treatments for excessive daytime sleepiness in patients with narcolepsy consist primarily of |
||||||
|
stimulants and wakefulness promoting agents, including Provigil (modafinil). Xyrem and Provigil are both |
||||||
|
approved for the treatment of excessive daytime sleepiness in patients with narcolepsy, but Xyrem is also |
||||||
|
approved for the treatment of cataplexy, the most well-recognized symptom of narcolepsy. |
||||||
|
. Provigil is also approved for the treatment of excessive daytime sleepiness in patients with obstructive |
||||||
|
sleep apnea/hypopnea syndrome and shift work sleep disorder, which may help make it more well-known |
||||||
|
to physicians and patients. |
||||||
|
Obsessive compulsive disorder |
||||||
|
. Although not FDA-approved for the treatment of obsessive compulsive disorder, based on data from the |
||||||
|
2006 Physicians Drug and Diagnosis Audit, JAZZ estimates that more than 15 additional products and their |
||||||
|
generic equivalents accounted for over 47% of total drug usage for the treatment of obsessive compulsive |
||||||
|
disorder in 2006 |
||||||
|
. Given the prevalence of generic products, in order to gain significant market acceptance, JAZZ will need |
||||||
|
to demonstrate that the benefits of Luvox CR to patients justify the higher price of a branded product. |
||||||
|
> Paxil, Zoloft, Prozac & Anafranil |
||||||
|
. Based on data from the 2006 Physicians Drug and Diagnosis Audit, JAZZ estimates that Paxil, Zoloft, |
||||||
|
Prozac and Anafranil (and each of their generic equivalents) and fluvoxamine accounted for 48% of the |
||||||
|
total drug usage for the treatment of obsessive compulsive disorder in 2006. |
||||||
|
. Four branded products are currently approved by the FDA for the treatment of obsessive compulsive |
||||||
|
disorder, including three selective serotonin reuptake inhibitors: Paxil (paroxetine HCl), which is marketed |
||||||
|
by GlaxoSmithKline, Zoloft (sertraline HCl), which is marketed by Pfizer, and Prozac (fluoxetine |
||||||
|
hydrochloride), which is marketed by Eli Lilly. Anafranil (clomipramine hydrochloride), the other branded |
||||||
|
product approved by the FDA for the treatment of obsessive compulsive disorder, is a tricyclic |
||||||
|
antidepressant marketed by Mallinckrodt in the United States. |
||||||
|
. The relative use of each of these products for the treatment of obsessive compulsive disorder has varied |
||||||
|
over the past ten years, and each currently has generic equivalents. |
||||||
|
. Generic products are generally sold at significantly lower prices than branded products, tending to both |
||||||
|
take market share away from branded products and put downward pricing pressure on branded products. |
||||||
|
Fluvoxamine, the generic equivalent of Luvox and a selective serotonin reuptake inhibitor, is the only other |
||||||
|
drug currently approved for the treatment of obsessive compulsive disorder. |
||||||
|
> Fluvoxamine |
||||||
|
Based on data from the 2006 Physicians Drug and Diagnosis Audit, JAZZ estimates that fluvoxamine use |
||||||
|
represented 11% of total drug usage for the treatment of obsessive compulsive disorder in 2006. |
||||||
|
. Prior to the introduction of generic fluvoxamine in 2000, Luvox was considered one of the preferred |
||||||
|
treatments of obsessive compulsive disorder. |
||||||
|
. Based on data from the 2005 Physicians Drug and Diagnosis Audit, JAZZ estimates that Luvox accounted |
||||||
|
for 21% of total drug usage for the treatment of obsessive compulsive disorder in 1999. |
||||||
|
Social anxiety disorder |
||||||
|
Based on limited data from the 2005 Physicians Drug and Diagnosis Audit, JAZZ estimates that Paxil CR |
||||||
|
use represented 5%, and Effexor XR use represented 9%, of total drug usage for the treatment of social |
||||||
|
anxiety disorder in 2006 |
||||||
|
. Four products are currently approved by the FDA for the treatment of social anxiety disorder, including |
||||||
|
three selective serotonin reuptake inhibitors: Zoloft, Paxil and Paxil CR, an extended release version of |
||||||
|
Paxil, and one serotonin-norepinephrine reuptake inhibitor, Effexor XR (venlafaxine HCl). Paxil CR and |
||||||
|
Effexor XR, developed and sold by GlaxoSmithKline and Wyeth, respectively, do not have generic |
||||||
|
equivalents, whereas Paxil and Zoloft have generic equivalents. |
||||||
|
. Paxil CR was approved for the treatment of social anxiety disorder in 2003 |
||||||
|
. Effexor XR was approved for the treatment of social anxiety disorder in 2003. |
||||||
|
As with obsessive compulsive disorder, in order to gain significant market acceptance, JAZZ will need to |
||||||
|
demonstrate that the benefits of Luvox CR to patients justify the higher price of a branded product. |
||||||
|
> Zoloft, Paxil, Paxil CR, Effexor XR |
||||||
|
. The presence in a particular patient of more than one psychiatric condition is an important consideration |
||||||
|
by physicians in the selection of drugs to treat social anxiety disorder. |
||||||
|
. For patients with multiple conditions, a selective serotonin reuptake inhibitor or a serotonin |
||||||
|
norepinephrine reuptake inhibitor with demonstrated efficacy in multiple indications is generally the |
||||||
|
preferred treatment option. Zoloft, Paxil, Paxil CR and Effexor XR are approved for additional psychiatric |
||||||
|
disorders, such as depression, in addition to social anxiety disorder, which may give them broader |
||||||
|
recognition by physicians and patients. |
||||||
|
. These products therefore may be more likely to be prescribed than Luvox CR which, if approved, would |
||||||
|
at most be indicated for the treatment of obsessive compulsive disorder and social anxiety disorder. |
||||||
|
Fibromyalgia |
||||||
|
Based on available market data, JAZZ estimates that more than 6.3 million total prescriptions were written |
||||||
|
to treat fibromyalgia syndrome symptoms in 2006, of which 32% were for antidepressants, 25% were for |
||||||
|
opioids and 30% were for muscle relaxants |
||||||
|
. There are currently no products approved by the FDA for the treatment of fibromyalgia syndrome. In |
||||||
|
clinical practice, a variety of drugs are often prescribed to address individual symptoms of fibromyalgia |
||||||
|
syndrome, including antidepressants, pain medications, muscle relaxants, hypnotics and anticonvulsants. |
||||||
|
. In addition to JZP-6 (from JAZZ), there are currently four programs that have completed or are in Phase |
||||||
|
III clinical development for the treatment of fibromyalgia syndrome. These include Lyrica (pregabalin), an |
||||||
|
anticonvulsant being developed by Pfizer, which has previously been approved by the FDA for the |
||||||
|
treatment of partial seizures, post herpetic neuralgia and diabetic peripheral neuropathy. |
||||||
|
. In December 2006, Pfizer submitted a supplemental NDA seeking FDA approval of Lyrica for the |
||||||
|
treatment of fibromyalgia syndrome, or certain symptoms associated with fibromyalgia syndrome. |
||||||
|
Epilepsy |
||||||
|
Seizures in epileptic patients are typically controlled by treatment with one or more antiepileptic drugs. |
||||||
|
. In 2006, there were 6.2 million prescriptions written for Lamictal. |
||||||
|
. While up to 70% of epilepsy patients respond to therapy and become seizure-free with chronic treatment |
||||||
|
with antiepileptic drugs, the remaining patients fail treatment either because the drugs do not stop their |
||||||
|
seizures or because they cannot tolerate the side effects. |
||||||
|
Bipolar Disorder |
||||||
|
Bipolar disorder is typically managed with drugs from a variety of different drug classes. |
||||||
|
. While treatment duration varies for each patient, treatment of an acute phase of the disease generally lasts |
||||||
|
three weeks, followed by a continuation phase of two months, and a maintenance phase of up to 18 |
||||||
|
months. |
||||||
|
. Generally, the treatment is chosen based on the mood episode a patient is experiencing at a particular time. |
||||||
|
. Treatment for patients in the acute mania phase includes a mood stabilizer, such as lithium or an |
||||||
|
antiepileptic drug, in addition to an atypical antipsychotic. Patients in the acute depression phase are |
||||||
|
initially treated with Lamictal, Symbyax (olanzapine and fluoxetine HCl capsules), a combination |
||||||
|
antidepressant and antipsychotic, or Seroquel (quetiapine), an antipsychotic. For long-term maintenance, |
||||||
|
the same medications that were effective for the acute episodes are typically continued at the same or lower |
||||||
|
doses. |
||||||
|
. Many of the drugs currently used in the treatment of bipolar disorder have adverse drug interactions |
||||||
|
affecting each drug's efficacy and safety as well as adverse tolerability and other negative side effects such |
||||||
|
as sedation, weight gain, involuntary movements, tremors, stiffness orthostatic hypotension and potentially |
||||||
|
life-threatening immune system reactions. |
||||||
|
. These side effects discourage compliance and may pose serious health risks. Antidepressants are also |
||||||
|
often prescribed to treat bipolar depression, even though they are not indicated for such treatment and there |
||||||
|
is a risk that such antidepressants can induce a bipolar patient to switch from depression to mania. |
||||||
|
Use of $158mm in IPO proceeds |
||||||
|
o $90.0 million to fund the planned U.S. launch and commercialization of Luvox CR, including $41.0 |
||||||
|
million for development and commercial milestone payments to Solvay in connection with the acquisition |
||||||
|
of U.S. rights to Luvox CR, $39.0 million for activities related to preparation for marketing, promotion and |
||||||
|
expansion of a specialty sales force and $10.0 million for production of initial commercial quantities of |
||||||
|
Luvox CR; |
||||||
|
o $25.0 million to fund Phase III pivotal clinical trials of JZP-6 through the completion of the first Phase III |
||||||
|
clinical trial, after which, if the trial is successful, would need an estimated $50.0 million to complete |
||||||
|
development and commercial launch of JZP-6; |
||||||
|
o remainder to fund continued development of and feasibility activities for the portfolio of clinical and |
||||||
|
early-stage product candidates during the next 12 to 18 months, as well as working capital, capital |
||||||
|
expenditures and other general corporate purposes |
||||||
|
=================== |
||||||
|
LDK Solar |
LDK, B-, 8 |
|||||
|
multicrystalline wafers for solar cells |
Post-IPO shrs: 104m |
|||||
|
Xinyu City, Jiangxi Province, China |
2006 |
March, 07* |
IPO Mkt |
|||
|
Rev ($mm) |
$105 |
$73 |
Cap (mm) |
|||
|
Gross profit % |
40% |
39% |
$2,704 |
|||
|
Operating income % |
35% |
35% |
@$26 |
|||
|
Profit (loss) |
$30 |
$24.5 |
||||
|
Profit (loss) % |
29% |
33% |
||||
|
Export sales |
*quarter ending March 31 |
|||||
|
% sales to China-based cos |
75% |
50% |
||||
|
% export sales |
||||||