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Note 1 - Business
3 Months Ended
Mar. 31, 2016
Notes to Financial Statements  
Business Description and Basis of Presentation [Text Block]
1.     Business
 
Overview
 
Heron Therapeutics, Inc. is a biotechnology company focused on improving the lives of patients by developing best-in-class medicines that address major unmet medical needs. We are developing novel, patient-focused solutions that apply our innovative science and technologies to already-approved pharmacological agents. Our goal is to build on therapeutics with well-known pharmacology by improving their tolerability and efficacy as well as broadening their potential field of use.  
 
 
We are currently developing pharmaceutical product candidates for patients suffering from cancer or pain. SUSTOL
®
(granisetron) Injection, extended release (“SUSTOL”), is a subcutaneous formulation being developed for the prevention of both acute and delayed chemotherapy-induced nausea and vomiting (“CINV”) associated with moderately emetogenic chemotherapy or highly emetogenic chemotherapy. Our New Drug Application (“NDA”) for SUSTOL is pending review with the U.S. Food and Drug Administration (“FDA”) and was assigned a Prescription Drug User Fee Act goal date of January 17, 2016. We were notified by the FDA of delays in the review of the SUSTOL NDA in January 2016, February 2016 and April 2016. On April 18, 2016, we announced the FDA had indicated that no substantive deficiencies had been identified with the NDA and labeling discussions had begun.
 
In addition to SUSTOL, we are currently developing HTX-019, an intravenous formulation of the neurokinin-1 receptor antagonist aprepitant, for the prevention of CINV and HTX-011, a long-acting injectable formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory agent meloxicam, for the prevention of post-operative pain.
 
Liquidity
 
We have incurred significant operating losses and negative cash flows from operations, and we had an accumulated deficit of $446.3 million as of March 31, 2016. As of March 31, 2016, we had cash, cash equivalents and short-term investments of $100.4 million.
 
We believe that our current working capital is sufficient to fund operations through 2016, including pursuing regulatory approval for SUSTOL in the U.S., completing Phase 2 clinical studies currently ongoing and expected to commence in 2016 relative to our HTX-011 product candidate, filing the NDA for HTX-019, and, if approved, continuing to make significant investments to support the commercialization of SUSTOL. In the event that we pursue additional clinical development with respect to our current product candidates,
pursue preclinical and/or clinical development in other areas, potentially acquire other strategic assets, or if SUSTOL is not approved or has less commercial success than is expected, we may need to raise additional capital or reduce our activities. We may seek additional capital through various sources, including debt and equity offerings, corporate collaborations, bank borrowings, arrangements relating to assets, sale of royalty streams we may receive on our products or other financing methods or structures. The source, timing and availability of any financings will depend on market conditions, development program progress, interest rates and other factors. Our capital requirements going forward will depend on numerous factors, including but not limited to: the scope, rate of progress, results and costs of preclinical testing and clinical trials; an approval decision by the FDA with respect to SUSTOL; the timing of and costs associated with the commercial launch of SUSTOL, if approved; the degree of commercial success of SUSTOL; the number and characteristics of product development programs we pursue and the pace of each program, including the timing of clinical trials; the time, cost and outcome involved in seeking other regulatory approvals; scientific progress in our research and development programs; the magnitude and scope of our research and development programs; our ability to establish and maintain strategic collaborations or partnerships for research, development, clinical testing, manufacturing and marketing of our product candidates; the cost and timing of establishing sales, marketing and distribution capabilities if we commercialize products independently; the cost of establishing clinical and commercial supplies of our product candidates and any products that we may develop; and general market conditions.
 
 
 
We may not be able to raise sufficient additional capital when we need it on favorable terms, or at all. The sale of additional equity in the future may be dilutive to our stockholders. If we are unable to obtain adequate funds on reasonable terms, we may be required to curtail operations significantly or to obtain funds by entering into financing, supply or collaboration agreements on unattractive terms.