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SEC Filings

10-Q
ATHENEX, INC. filed this Form 10-Q on 05/09/2019
Entire Document
 

 

 

Continue our current preclinical and clinical research program and development activities;

 

Advance the preclinical and clinical research program and development activities of our recently in-licensed technology platforms, TCR-T Immunotherapy and Arginine Deprivation Therapy;

 

Seek to identify additional research programs and product candidates;

 

Continue to invest in acquiring or in-licensing other drugs and technologies;

 

Continue to invest in our manufacturing facilities;

 

Continue to invest in further developing our Commercial Platform ahead of our intended proprietary drug launch;  

 

Hire additional research, development and business personnel;

 

Maintain, expand and protect our intellectual property portfolio; and

 

Incur additional costs associated with operating as a public company.

On May 7, 2019, we completed a private placement equity offering of 10 million shares of common stock. All shares were offered by us at a price of $10.00 per share to three institutional investors, namely Perceptive Advisors, Avoro Capital Advisors (formerly known as venBio Select Advisor), and OrbiMed. The aggregate net proceeds received by us from the offering were $99.8 million, net of offering expenses of approximately $0.2 million.

We have funded our operations to date primarily from the issuance and sale of our common stock through public offerings, private placements, and convertible bonds, debt and, to a lesser extent, through revenue generated from our Global Supply Chain Platform. As of March 31, 2019, we had cash, cash equivalents and short-term investments of $71.3 million.  

Key Components of Results of Operations

Revenue

We derive our consolidated revenue primarily from (i) the sales of 503B and API products by our Global Supply Chain Platform; (ii) the sales of generic injectable products by our Commercial Platform; (iii) licensing and collaboration projects conducted by our Oncology Innovation Platform, which generates revenue in the form of upfront payments, milestone payments and payments received for providing research and development services for our collaboration projects and for other third parties; and (iv) grant awards from government agencies and universities for our continuing research and development efforts.

We do not anticipate revenue being generated from sales of our product candidates under development in our Oncology Innovation Platform until we have obtained regulatory approval. We cannot assure you that we will succeed in achieving regulatory approval for our drug candidates as planned, or at all.

Cost of Sales

Along with sourcing from third-party manufacturers, we manufacture clinical products in our cGMP facility in New York and APIs at our cGMP facility in China through our Global Supply Chain Platform. Cost of sales primarily includes the cost of finished products, raw materials, labor costs, manufacturing overhead expenses and reserves for expected scrap, as well as transportation costs. Cost of sales also includes depreciation expense for production equipment, changes to our excess and obsolete inventory reserves, and certain direct costs such as shipping costs, net of costs charged to customers.

Research and Development Expenses

Research and development expenses consist of the costs associated with in-licensing of product candidates, milestone payments, conducting preclinical studies and clinical trials, activities related to regulatory filings and other research and development activities. Our current research and development activities mainly relate to the clinical development of the following programs:

Orascovery platform—Comprised of our in-licensed and novel P-gp inhibitor, HM30181A, that is combined with various chemotherapeutic agents and enables the agents to be absorbed into the blood when given orally:

 

Oraxol, combining HM30181A with an oral dosage form of paclitaxel;

 

Oratecan, combining HM30181A with an oral dosage form of irinotecan;

 

Oradoxel, combining HM30181A with an oral dosage form of docetaxel;

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