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Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) is a San Diego-based specialty biopharmaceutical company
focused on developing and commercializing products in the therapeutic areas of respiratory disease, allergy, oncology
and immunology. Its specialty pharmaceuticals division, which currently has four products in its pipeline, is creating
low-cost therapeutic alternatives to existing treatments in large markets. Adamis will pursue 505(b)(2) regulatory ap-
proval filings for these products in order to minimize costs and shorten the time to market. The Company also has a
four-product biotechnology pipeline that it is currently considering all of its options for how to strategically partner the
assets. Therefore, the biotech division should be viewed as a free call option that could add value to shareholders.
Specialty Pharmaceutical Pipeline
Epinephrine Pre-Filled Syringe — Addressable Market $900 M
The Epinephrine Pre-Filled Syringe (PFS) will compete as a simple, intuitive, low-cost therapeutic alternative to epi-
nephrine auto injectors like Mylan’s EpiPen® in the anaphylaxis market. In the U.S., an estimated 5% of the population
suffers from insect sting anaphylaxis, up to 6% are latex sensitive and up to 1.5% of adults and 5% of children under
three years of age experience food related anaphylaxis. Prescriptions have grown annually as the risk of anaphylaxis
has been more widely understood. Estimated sales for Mylan’s EpiPen® for 2013 was over $800 million and growing
~15% annually. ADMP expects FDA approval and commercial launch during the first half of 2015 at a significant
price discount to its peers.
HFA Branded Generic Inhaled Oral Steroid — Addressable Market $2.7 B
APC-1000 is a branded generic inhaled oral steroid for the treatment of asthma and COPD. For APC-1000, Adamis is
using a well-known steroid (beclomethasone) and combining it with a HFA propellant to create a pulmonary metered
dose inhaler (pMDI) with global potential. The Company believes that clinical and regulatory risks for this product are
low, since this steroid has been well accepted and the clinical trial path to approval is well known. Adamis’ manufac-
turer, Beximco, has demonstrated the know-how and ability to manufacture complex HFA products-overcoming the
barriers to entry that have made it difficult for other firms to develop such products. Beximco currently manufactures
and sells an APC-1000 like product for developing countries. ADMP intends to begin a pharmacokinetic (PK) study in
the 4Q of 2014 and a Phase III study in the first half of 2015. The Company estimates the commercial launch during
2016.
HFA Branded Generic Inhaled Nasal Steroid — Addressable Market $2.0 B
APC-3000 is a HFA branded generic inhaled nasal steroid for the treatment of seasonal and perennial allergic rhinitis.
With the discontinuation of CFCs as propellants, this market has moved from gas propelled steroids to aqueous pumped
steroids. However, many patients have difficulty using the aqueous delivered products, and the Company believes that
there is an important unmet need to offer again the once dominant gas propelled inhaled nasal steroids. Adamis' strate-
gy is to target that market segment by using a steroid that is well-known by both the FDA and the doctors who are do-
ing the prescribing. This strategy helps to reduce the regulatory risk, since the company uses a well-known steroid that
is off patent and couples it with an environmentally friendly HFA (a gas that has been cleared by the FDA). ADMP
estimates a commercial launch in 2016/2017 time frame.
Branded Generic Dry Powder Inhaler — Addressable Market $8.2 B worldwide
APC-5000 is Adamis' first product using the Taper Dry Powder Inhalation (DPI) technology that the Company has
acquired from 3M Drug Delivery Systems. The Taper DPI is a patented pre-metered device that Adamis expects will
have a number of advantageous features when compared to competing DPI products including: greater efficiency, less
dependence on the individual's inspiratory flow rate, no need for excipients in most formulations, capability of deliver-
ing up to 120 doses (a two month supply), moisture protection, and ease of use. In addition, the device has been de-
signed to reduce the likelihood of delivering a double dose. ADMP intends to initiate a PK study (proof-of-concept) in
the 4Q of 2014 and estimates a commercial launch in 2017. This platform technology can provide several follow-on
products that can drive revenues for the foreseeable future.
Investment Conclusions
Adamis has four product launches anticipated between 2015 and 2017 in the multi-billion dollar allergy and respiratory
markets. Given its product’s competitive advantages, including being lower cost alternatives to existing products cou-
pled with increased price sensitivity of consumers, the Company should be able to penetrate a meaningful percentage of
these large and growing markets. As such, it represents a compelling investment for investors at these levels as well as
an attractive M&A target by any of the major pharmaceutical companies.
ACORN MANAGEMENT P ARTNERS
AMP Quick Facts Adamis Pharmaceuticals, Inc. (ADMP)
For More Information
Contact: Austin Gilbert
Acorn Management
Partners
678-736-5671
November 5, 2014
Healthcare
Symbol: ADMP
Last Price: $4.46
(November 5, 2014)
Sector: Healthcare
Industry: Specialty
Pharmaceuticals
Debt: $0
Cash: $5.9M
(September 30, 2014)
52 Week Range:
Low $2.62
High $11.90
Market Size: $30.0B+
Market-Cap: $46.8M
Shares: O/S 10.5 M
Float: 8.1 M
Avg. Vol. (90 days):
85,039
Adamas Pharmaceuticals, Inc., 11682 El Camino Real, Suite 300, San Diego, CA 92130
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