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Note 1 - Organization and Business | 12 Months Ended
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Dec. 31, 2017
Notes to Financial Statements |
Business Description and Basis of Presentation [Text Block] |
1. | Organization and Business
Heron Therapeutics, Inc. (“Company”, “Heron”, or “we”) is a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments that address some of the most important unmet patient needs. We are developing novel, patient-focused solutions that apply our innovative science and technologies to already approved pharmacological agents for patients suffering from cancer or pain. On August 9, 2016, our first commercial product, SUSTOL ® (granisetron) extended-release injection (“SUSTOL”), was approved by the U.S. Food and Drug Administration (“FDA”). We developed SUSTOL for the prevention of chemotherapy-induced nausea and vomiting (“CINV”). SUSTOL is indicated, in combination with other antiemetics, in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (“MEC”) or anthracycline and cyclophosphamide combination chemotherapy regimens. We commenced commercial sales of SUSTOL in the U.S. in October 2016. On November 9, 2017, our second commercial product, CINVANTI™ (aprepitant) injectable emulsion (“CINVANTI”), was approved by the FDA. CINVANTI is an intravenous formulation of the neurokinin- 1 receptor antagonist aprepitant. We developed CINVANTI for the prevention of CINV as an adjunct to other antiemetic agents. CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of high emetogenic cancer chemotherapy including high-dose cisplatin and nausea and vomiting associated with initial and repeat courses of MEC. We commenced commercial sales of CINVANTI in the U.S. in January 2018. HTX- 011 is a long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the prevention of postoperative pain. By delivering sustained levels of both a potent anesthetic and an anti-inflammatory agent directly to the site of tissue injury, HTX- 011 was designed to provide superior pain relief while potentially reducing the need for systemically administered pain medications such as opioids, which carry the risk of harmful side effects, abuse and addiction. The Phase 2 development program for HTX- 011 was designed to target the many patients undergoing a wide range of surgeries who experience significant postoperative pain. Following an End-of-Phase 2 meeting with the FDA, we initiated our Phase 3 program, which completed enrollment in January 2018. We anticipate reporting top-line results in the first half of 2018, and we expect to file a New Drug Application for HTX- 011 in the second half of 2018. We have been granted Fast Track designation for HTX- 011 by the FDA for local administration into the surgical site to reduce postoperative pain and the need for opioid analgesics for 72 hours. Fast Track designation is intended to facilitate the development and expedite the review of new therapies to treat serious conditions with unmet medical needs by providing sponsors with the opportunity for frequent interactions with the FDA. We have incurred significant operating losses and negative cash flows from operations. As of December 31, 2017, our accumulated deficit was $783.5 million, and we had $172.4 million in cash, cash equivalents and short-term investments. Based on our current operating plan and projections, management believes that available cash, cash equivalents and short-term investments are sufficient to fund operations for at least one year from the date this Annual Report on Form 10 -K is filed with the U.S. Securities and Exchange Commission (“SEC”).

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- Definition The entire disclosure for the business description and basis of presentation concepts. Business description describes the nature and type of organization including but not limited to organizational structure as may be applicable to holding companies, parent and subsidiary relationships, business divisions, business units, business segments, affiliates and information about significant ownership of the reporting entity. Basis of presentation describes the underlying basis used to prepare the financial statements (for example, US Generally Accepted Accounting Principles, Other Comprehensive Basis of Accounting, IFRS). + References Reference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 205 -URI http://asc.fasb.org/topic&trid=2122149 Reference 2: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 275 -URI http://asc.fasb.org/topic&trid=2134479 Reference 3: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 235 -URI http://asc.fasb.org/topic&trid=2122369 + Details
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