IPO Report: Tobira Therapeutics (TBRA)

Tobira Therapeutics (TBRA) is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics to treat liver disease, human immunodeficiency virus, or HIV, fibrosis and inflammation. Headquartered in South San Francisco, CA.

Nineteen other companies are scheduled to IPO for the week of July 28, 2014.  The full IPO calendar is available at IPOpremium.

The manager and co-managers are BMO Capital Markets, JMP Securities, Oppenheimer.

TBRA scheduled a $60 million IPO with a market capitalization of $143 million at a price range midpoint of $13 for Thursday, July 31, 2014 on the Nasdaq.  SEC filings

TBRA IPO Overview

TBRA is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics to treat liver disease, human immunodeficiency virus, or HIV, fibrosis and inflammation.

TBRA Valuation

Glossary

Conclusion on TBRA IPO

The price to book value is 2.5

Existing shareholders and affiliates have indicated an interest in purchased $15-20 million of the IPO.  $17.5 million would be 29% of the IPO.

The rating is neutral.

Tobira Business

TBRA is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics to treat liver disease, human immunodeficiency virus, or HIV, fibrosis and inflammation.

Phase 2 trial planned for 2nd half of 2014 for lead product candidate

TBRA’s lead product candidate, cenicriviroc, or CVC, is a proprietary immunomodulator that can potentially be used to treat a number of disease states with high unmet medical need. TBRA is developing CVC for nonalcoholic steatohepatitis, or NASH, for which TBRA plans to begin a Phase 2 clinical trial in the second half of 2014.

Second Product Candidate

TBRA also plans to advance CVC in a fixed-dose combination for HIV type 1, or HIV-1, infection through Phase 3 development and commercialization in collaboration with a strategic partner or with non-dilutive financing.

CVC is a once-daily pill with well-established safety and tolerability in approximately 550 subjects dosed in completed Phase 1 and Phase 2 trials, including 115 HIV-1 infected subjects on treatment for up to 48 weeks.

CVC is a first-in-class oral, long-acting, once-daily, potent dual inhibitor, or antagonist, of chemokine receptor type 2, or CCR2, and type 5, or CCR5, with anti-inflammatory and anti-fibrotic activity.

TBRA is initially developing CVC for NASH, a liver disease characterized by fatty deposits, cellular damage, inflammation and fibrosis.

CVC binds to both CCR2 and CCR5 and blocks the migration of immune cells to the liver in response to cellular damage, thereby disrupting the immuno-inflammatory cascade and the activation of fibrosis generating hepatic stellate cells, or HSCs.

TBRA believes CVC is an excellent candidate for the chronic treatment of NASH due to its safety profile in healthy subjects and HIV patients and first-in-class dual mechanism of action targeting fibrosis-generating cells.

TBRA believes there are no other product candidates in development or approved for NASH that target the immuno-inflammatory pathways responsible for fibrosis.

NASH is a severe type of non-alcoholic fatty liver disease, or NAFLD. NAFLD is the most common liver disease and is associated with obesity and type-2 diabetes and is characterized by the accumulation of fat in the liver with no other apparent causes.

The rising prevalence of obesity-related disorders has contributed to a rapid rise in the prevalence of NASH and NAFLD.

In the United States, NAFLD affects approximately 27%-34% of the population, or an estimated 86 million to 108 million people.

Approximately 10%-20% of people with NAFLD will progress to NASH. Current estimates place NASH prevalence at approximately 9 million to 15 million people in the United States, or 3%-5% of the population, with similar prevalence in other major markets.

Prevalence is also rising in developing regions, likely due to the adoption of a more sedentary lifestyle and westernized diet consisting of processed food with high fat and fructose content.

TBRA Dividend Policy

No dividends are planned.

Tobira's Intellectual Property

TBRA owns exclusively several patents covering CVC which it obtained from Takeda, and have also licensed intellectual property relating to CVC from Takeda.

Patents owned by or licensed to TBRA covering CVC composition of matter are expected to expire in the United States in 2022, before any potential patent term extensions or exclusivity protection or adjustments for patent office delays, and in 2023 when such adjustments for patent office delays are considered.

TBRA owns or has rights to additional patents and pending patent applications that cover formulations, combination products, and use of CVC to treat various indications with expected patent expiration dates in the United States that range from 2022 (for issued patents) to potentially 2035 (for currently-filed provisional patent applications if patents were to issue on non-provisional applications filed thereon).

Tobira's Competition

TBRA faces significant competition from large multinational pharmaceutical companies, established biotechnology companies and specialty pharmaceutical companies, which have materially greater financial, manufacturing, marketing, research and drug development resources than TBRA does.

Large pharmaceutical companies in particular have extensive expertise in preclinical and clinical testing and in obtaining regulatory approvals for drugs.

Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies.

In addition, academic institutions, government agencies and other public and private organizations conducting research may seek patent protection with respect to potentially competitive products or technologies.

These organizations may also establish exclusive collaborative or licensing relationships with TBRA’s competitors.

TBRA believes the key competitive factors that will affect the development and commercial success of its product candidates are efficacy, safety and tolerability profile, reliability, convenience of dosing, price and reimbursement.

TBRA is aware of several companies with development programs targeting NASH in clinical trials including Intercept Pharmaceuticals, Inc., Gilead Sciences, Inc., Galmed Medical Research Ltd., Genfit Corp., Novartis AG, Takeda Pharmaceutical Company Limited, or Takeda, Raptor Pharmaceutical Corp., Immuron Ltd., Shire plc and Conatus Pharmaceuticals Inc. TBRA is not aware of a competitor with an active development program for NASH targeting CCR2/CCR5 inhibition.

5% Stockholders

Frazier Healthcare V, L.P.           25.3%

Funds affiliated with Montreux Equity Partners 17.5%

Patrick Heron 25.3%                                                   

Use of Proceeds

TBRA intends to use the $52 million in proceeds from its IPO as follows:

to fund the further development and commercialization of CVC for the treatment of NASH,

including a Phase 2 clinical trial that TBRA expects to initiate in the second half of 2014, and other immuno-inflammatory and fibrosis indications, as well as for manufacturing of clinical drug supply, working capital and general corporate purposes.

TBRA estimates that the proceeds from this offering, together with its current resources, can fund operations through the completion of the CENTAUR study.

Although TBRA cannot specify with certainty the particular amounts or uses for the net proceeds from this offering, TBRA currently intends to use approximately $35 million for the development of CVC for the treatment of NASH including TBRA’s planned Phase 2 clinical trial of CVC for the treatment of NASH, approximately $5 million for other immuno-inflammatory and fibrosis indications, approximately $4 million for manufacturing of clinical drug supply and the remainder for working capital and general corporate purposes.

Accordingly, TBRA’s management will have broad discretion in using the net proceeds from this offering.