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IPO Report: Jaguar Animal Health (JAGX)

Jaguar Animal Health ($JAGX) is an animal health company focused on developing and commercializing first-in-class gastrointestinal products for companion and production animals. It is based in San

Jaguar Animal Health ($JAGX) is an animal health company focused on developing and commercializing first-in-class gastrointestinal products for companion and production animals. It is based in San Francisco, CA.

Ten other companies are scheduled for the week of Nov. 3, 2014. The full IPO calendar is available at IPOpremium.

SEC Documents

Manager, Joint-managers: BMO Capital Markets and Guggenheim Securities

Co-manager: Roth Capital Partners

End of lockup (180 days): Monday, May 4, 2015

End of 25-day quiet period: Monday, Dec. 1, 2014

JAGX scheduled a $40 million IPO with a market capitalization of $80 million at a price range midpoint of $8 for Wednesday, Nov. 5, 2014 on Nasdaq.

Jaguar Animal Health IPO Report

Summary

JAGX is an animal health company focused on developing and commercializing first-in-class gastrointestinal products for companion and production animals. Canalevia is JAGX’s lead prescription drug product candidate for the treatment of various forms of watery diarrhea in dogs.

Valuation

Glossary

Valuation Ratios

Mrkt Cap (mm)

Price /Sls

Price /Erngs

Price /BkVlue

Price /TanBV

% offered in IPO

.

           

Jaguar Animal Health JAGX)

$80

no rev

-10.3

2.1

2.1

50%

             

Conclusion

NeutralIntroducing new product for diatrectic dogs

No rev, P/E of -10.3

Business

JAGX is an animal health company focused on developing and commercializing first-in-class gastrointestinal products for companion and production animals. Canalevia is JAGX’s lead prescription drug product candidate for the treatment of various forms of watery diarrhea in dogs.

JAGX expects to announce data from its proof-of-concept study of Canalevia for general acute watery diarrhea in dogs in the fourth quarter of 2014.

JAGX also expects to initiate filing of a rolling new animal drug application, or NADA, for Canalevia for chemotherapy-induced diarrhea, or CID, in dogs, by the end of 2014.

Canalevia is a canine-specific formulation of crofelemer, an active pharmaceutical ingredient isolated and purified from the Croton lechleri tree.

A human-specific formulation of crofelemer, Fulyzaq, was approved by the U.S. Food and Drug Administration, or FDA, in 2012 for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy.

Members of JAGX’s management team developed crofelemer, including while at Napo Pharmaceuticals, Inc., or Napo.

Neonorm is JAGX’s lead non-prescription product to improve gut health and normalize stool formation in animals suffering from watery diarrhea, or scours.

JAGX recently launched Neonorm in the United States for preweaned dairy calves under the brand name Neonorm Calf and expect to launch additional formulations of Neonorm for other animal species beginning in 2015.

Neonorm is a botanical extract also derived from the Croton lechleri tree. Canalevia and Neonorm are distinct products that are formulated to address specific species and market channels. JAGX has filed eight investigational new animal drug applications, or INADs, with the FDA and intend to develop species-specific formulations of Neonorm in six additional target species.

Diarrhea is one of the most common reasons for veterinary office visits for dogs and is the second most common reason for visits to the veterinary emergency room, yet there are no FDA-approved anti-secretory products for the treatment of diarrhea.

JAGX estimates that in the United States, veterinarians see approximately six million annual cases of acute and chronic watery diarrhea in dogs, approximately two-thirds of which are acute watery diarrhea. JAGX believes Canalevia will be effective in treating watery diarrhea because it acts at the last physiological step, conserved across mammalian species, in the manifestation of watery diarrhea, regardless of cause, by normalizing ion and water flow in the intestinal lumen.

JAGX is first seeking a minor use, minor species, or MUMS, designation for Canalevia for CID in dogs to shorten the timeframe to commercialization.

If JAGX receives conditional approval pursuant to MUMS designation, it expects to commercialize Canalevia for CID in dogs in early 2016. JAGX is also enrolling a placebo-controlled proof-of-concept study of approximately 240 treated dogs with multiple preselected and distinct types of watery diarrhea.

JAGX is conducting this study to support full approval of Canalevia for CID, as well as protocol concurrence discussions with the FDA regarding expansion of labeled indications of watery diarrhea beyond CID, to include general acute watery diarrhea. JAGX plans to market Canalevia, if approved, through its focused direct sales force and to complement its internal efforts with distribution partners.

Intellectual property

Under the Napo License Agreement, JAGX has exclusive rights in the veterinary field to an international patent family related to International Patent Application WO1998/16111. The patents and patent applications in this family are directed to enteric protected formulations of proanthocyanidin polymers isolated from Croton spp. (such as crofelemer and Neonorm), and methods of treating watery diarrhea using the enteric protected formulations for both human and veterinary uses.

As such, the patents and patent applications of this family cover certain formulations of crofelemer, including Canalevia, as well as the standardized botanical extract in Neonorm, and methods of treating diarrhea using these formulations.

There are three U.S. patents and a pending U.S. patent application in this family, including, US 7,323,195, which has a term until at least June 7, 2018, US 7,341,744, which has a term until at least January 11, 2018, and US 8,574,634, which has a term until at least February 4, 2018.

Competition

The animal health industry is dominated by large independent companies such as Zoetis Inc., a stand alone animal health company that was spun out from Pfizer, Inc. in 2013, as well as subsidiaries of large pharmaceutical companies, including Novartis Animal Health Inc., a subsidiary of Novartis International AG., Merck Animal Health, the animal health division of Merck & Co., Inc., Merial Limited, the animal health division of Sanofi S.A., Elanco Animal Health, the animal health division of Eli Lilly and Company, Bayer Animal Health GmbH, a subsidiary of Bayer AG, and Boehringer Ingelheim Animal Health, the animal health division of Boehringer Ingelheim GmbH. There are also animal health companies based in Europe, including Vétoquinol S.A., Virbac S.A., Dechra Pharmaceuticals PLC and Ceva Animal Health S.A.

Additionally, smaller animal health companies, such as Aratana Therapeutics, Inc., Kindred Biosciences, Inc., Phibro Animal Health Corporation and Parnell Pharmaceuticals Holdings Ltd, recently completed initial public offerings of their stock in the United States and may choose to develop competitive products. JAGX believes that the large human pharmaceutical companies may also decide to spin out their animal health subsidiaries into stand alone companies.

5% shareholders pre-IPO

Napo Pharmaceuticals, Inc.        53.8%

Entities affiliated with BVCF       31.3%             

James J. Bochnowski    7.5%

Zhi Yang, Ph.D.            31.3%  

Dividends

No dividends are planned.

Use of proceeds

JAGX expects to receive $35 million from its IPO and use it for the following:

$3.6 million for clinical studies and regulatory approval costs related to Canalevia for CID ($0.3 million) and general acute watery diarrhea ($3.3 million) in dogs;

$6.2 million for clinical studies and regulatory approval costs related to the other prescription drug products in its pipeline, namely species-specific formulations of crofelemer for general acute watery diarrhea in cats ($1.7 million), acute colitis in horses ($0.6 million), gastric and colonic ulcers in horses ($2.0 million) and the herpes virus in cats ($0.4 million), as well as proof-of-concept studies for NP-500 ($1.5 million);

$2.0 million for studies and commercial activities inside and outside the United States related to Neonorm for improving gut health and normalizing stool formation in preweaned dairy calves ($1.1 million) and for the equine field ($0.9 million);

$1.6 million for the formulation costs associated with developing species-specific formulations of its products and for other third-party costs;

$2.1 million for establishing third-party manufacturing capability, including the technology transfer and manufacturing and support equipment at Indena S.p.A. pursuant to its memorandums of understanding;

and the remaining funds will be utilized for working capital and general corporate purposes.

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