IPO Report: Anterios (ANTE)

Francis Gaskins |

Anterios (ANTE) is a clinical stage biopharmaceutical company focused on the development, manufacturing and commercialization of novel botulinum products for therapeutic and aesthetic applications. It is based in New York, NY.

Eleven other companies are scheduled for the week of May 4. The full IPO calendar is available at IPO Premium.

SEC Documents

Manager, Joint-managers: Stifel, RBC
Co-managers: JMP Securities, Needham & Company

End of lockup (180 days): Wednesday, November 4, 2015
End of 25-day quiet period: Tuesday, June 2, 2015

ANTE scheduled a $51 million IPO with a market capitalization of $175 million at a price range midpoint of $13 for Friday, May 8, 2015 on Nasdaq.

Anterios Summary

ANTE is a clinical stage biopharmaceutical company focused on the development, manufacturing and commercialization of novel botulinum products for therapeutic and aesthetic applications.

The botulinum toxin type A, or botulinum, market is currently a $2.8 billion global market. All currently approved and commercially available botulinum products are administered by injection.

Lead product is a topical formulation, not like injectible Botox

Anterios Valuation

Glossary

Valuation Ratios

Mrkt Cap (mm)

Price /Sls

Price /Erngs

Price /BkVlue

Price /TanBV

% offered in IPO

Anterios (ANTE)

$176

no rev

-31.3

3.5

3.6

29%

             

Anterios Conclusion

Lead product is a topical version of botox etc ($2.8bb global market)

Neutral

Planning Phase 2 trials, topical not injection based

Price-to-book of 3.5, a little on the high side

P/E of -31, indicating relatively low cash burn rate relative to market cap

No revenue

Shareholders not buying

No strategic partners

Anterios Business

ANTE is a clinical stage biopharmaceutical company focused on the development, manufacturing and commercialization of novel botulinum products for therapeutic and aesthetic applications.

The botulinum toxin type A, or botulinum, market is currently a $2.8 billion global market. All currently approved and commercially available botulinum products are administered by injection.

Anterios Lead Product, Topical Formulation, Not Like Injectible Botox

ANTE’s lead product candidate, ANT-1207, is a ready-to-use topical formulation of botulinum, which ANTE is  developing for the treatment of primary axillary hyperhidrosis, or excessive underarm sweating, facial acne and lateral canthal lines, also called "crow's feet" wrinkles.

ANTE believes that, with ANT-1207, ANTE has the potential to expand the botulinum market by increasing the use of botulinum in currently approved indications and by pursuing new indications, such as acne.

ANTE has exclusive patent rights covering the use of botulinum for the treatment of acne. ANTE has successfully completed multi-center, double-blind, randomized, clinical trials of ANT-1207 in primary axillary hyperhidrosis, facial acne, and lateral canthal lines and are currently planning Phase 2b clinical trials in each indication.

ANTE believes topical treatment with ANT-1207 would have substantial advantages over injections for both physicians and patients, including the elimination of the pain, bleeding and bruising associated with needle-sticks.

ANTE has completed a 71-patient multi-center, double-blind, controlled, randomized, sequential dose-escalation clinical trial for ANT-1207 in the United States, which demonstrated a clinically meaningful and statistically significant improvement in primary axillary hyperhidrosis as compared to patients who received inactive vehicle control.

Based on its clinical trial results and its analysis of Botox's pivotal clinical trial data, ANTE believes that its clinical trial results for ANT-1207 are consistent with those found for injected Botox.

ANTE is currently planning a Phase 2b clinical trial in approximately 150 primary axillary hyperhidrosis patients to establish the dose for its Phase 3 clinical trials.

ANTE expects to initiate the Phase 2b clinical trial in the first half of 2015 and to report results at the end of 2015

Anterios Second Product Candidate

ANTE’s second product candidate, AI-09, is a novel injectable formulation of botulinum that is packaged as a ready-to-use liquid preparation for indications where deeper delivery of the botulinum is required.

ANTE believes AI-09 will have advantages over existing injectable products, which are all packaged as powders and are not ready-to-use. Both ANT-1207 and AI-09 combine purified botulinum, derived from ANTE’s proprietary cell line, with its proprietary NDS formulation technology.

ANTE owns the worldwide rights to ANT-1207, AI-09, and the NDS formulation technology.

ANTE’s lead indication for ANT-1207 is primary axillary hyperhidrosis.

Approximately 2.8% of the U.S. population is estimated to suffer from hyperhidrosis, which equates to approximately 9 million people based on the current population of the United States.

Hyperhidrosis is excessive sweating that may occur in the underarms, hands, feet, forehead and other areas of the body.

The most common area affected by hyperhidrosis is the underarms, which is called primary axillary hyperhidrosis.

This condition is believed to be caused by dysregulation of the sweat glands that are controlled by nerves in the underarms that regulate the degree of sweating by releasing the neurotransmitter acetylcholine which stimulates sweat production.

Botulinum blocks acetylcholine release from the nerve cells and thereby reduces sweat production. Botox, an injectable botulinum product, is approved as a treatment for primary axillary hyperhidrosis, but requires up to 30 injections into the underarms during a single office visit.

Anterios Intellectual Property

ANTE owns or licenses rights to 30 issued patents and 95 pending patent applications, including foreign counterparts of U.S. patents and applications.

Relating to ANT-1207, ANTE owns or licenses rights to 23 issued patents and 63 pending patent applications, including foreign counterparts of U.S. patents and applications.

These patent filings address composition of matter, methods of use including treatment of specific conditions, and manufacturing.

Four of ANTE’s patents are issued in the United States, with the rest issued in Australia, Canada, China, various countries in Europe, Japan, Mexico, New Zealand, Singapore, South Africa and South Korea. In addition, ANTE has pending patent applications in the United States as well as in Australia, Canada, China, various countries in Europe, Hong Kong, India, Israel, Japan, Mexico, New Zealand, Singapore, South Africa and South Korea.

In the United States, the expected date of the last to expire currently issued patent is December 31, 2030. Because approval of ANT-1207 is still pending, one of ANTE’s U.S. patents may be eligible for a patent term extension for up to five years, provided the total period of patent protection based on the extended patent does not exceed 14 years.

Anterios Competition

ANTE’s competitors in the prescription pharmaceutical market are companies offering approved injectable dosage forms of botulinum that are either approved or applied off-label for the indications that ANTE is currently targeting with ANT-1207 and ANT-09, including:

Botox, marketed by Allergan, which, since its original approval by the FDA in 1989, has been approved for multiple indications, including primary axillary hyperhidrosis, lateral canthal lines, and glabellar lines.

Dysport, an injectable botulinum approved by the FDA in 2009 for the treatment of glabellar lines and cervical dystonia. Dysport is marketed by Ipsen Ltd. and Galderma S.A. Dysport is also marketed as Azzalure in European Union countries.

Xeomin, marketed by Merz Aesthetics, Inc, approved by the FDA in 2010 for cervical dystonia and blepharospasm in adults previously treated with Botox. Bocouture®, rebranded from Xeomin, received approval for glabellar lines in Germany in 2009.

In 2010, Bocouture was approved in other significant markets within the European Union for glabellar lines. In 2011, Xeomin was approved by the FDA for glabellar lines.

Anterios 5% Shareholders Pre-IPO

Funds affiliated with Ascent Biomedical Ventures           18.2%

Funds affiliated with Scientific Health Development, Ltd.             11.6%

Jon Edelson, M.D.        19.1%

Carter Meyer, J.D.         11.6%              

Anterios Dividends

No dividends are planned.

Anterios Use of Proceeds

ANTE expects to receive $45 million from its IPO and use it for the following:

$1.5 million to fund clinical development for ANT-1207 for primary axillary hyperhidrosis through completion of Phase 2 clinical development;

$1.5 million to fund clinical development for ANT-1207 for facial acne through completion of Phase 2 clinical development;

$1.5 million to fund clinical development for ANT-1207 for lateral canthal lines through completion of Phase 2 clinical development;

$2 million to fund two initial clinical trials, if the IND is accepted by the FDA, for AI-09 for glabellar lines through completion of Phase 2 clinical development; and

the remainder for working capital, research and development infrastructure and general corporate purposes.

DISCLOSURE: The views and opinions expressed in this article are those of the authors, and do not represent the views of equities.com. Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions. To read our full disclosure, please go to: http://www.equities.com/disclaimer

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