Business

Overview

We are

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.

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 or anthracycline and cyclophosphamide combination chemotherapy regimens. We commenced commercial sales of SUSTOL in

October 2016.

We have

two

investigational pharmaceutical products for patients suffering from cancer or postoperative pain.

CINVANTI™

(HTX-

019

) (“CINVANTI”), an intravenous formulation of the neurokinin-

receptor antagonist aprepitant, has been developed for the prevention of CINV as an adjunct to other antiemetic agents. We submitted a New Drug Application (“NDA”) with the FDA for CINVANTI. Our NDA is pending review with the FDA and has been assigned a Prescription Drug User Fee Act goal date of

November 12, 2017.

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

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

meeting with the FDA, we initiated our Phase

program, which we anticipate completing in the

first

half of

2018.

We expect to file an NDA for HTX-

011

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

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.

The accompanying unaudited condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. We have incurred signifi

cant operating losses and negative cash flows from operations. As of

September 30, 2017,

our accumulated deficit was

$721.0

million, and we had

$74.0

million in cash, cash equivalents and short-term investments. Our capital requirements going forward will depend on numerous factors, including, but

not

limited to: the degree of commercial success of SUSTOL; the scope, rate of progress, results and costs of preclinical testing and clinical trials; the timing and cost to manufacture our products; an approval decision by the FDA with respect to CINVANTI; the timing and costs associated with the commercial launch of CINVANTI, if approved; the degree of commercial success of CINVANTI, if approved; 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 expect to satisfy our future cash needs through public or private equity offerings, debt financings, strategic collaborations and licensing arrangements, or other sources of financing. We cannot be certain that additional funding will be available to us on acceptable terms, or at all. Our ability to obtain new financing

may

be constrained by our failure to achieve significant business objectives, covenants applicable to our Senior Secured Convertible Notes (the “Convertible Notes”) and Subordinated Secured Promissory Note (the “Promissory Note”), and numerous other factors. These factors, among others, raise substantial doubt about our ability to continue as a going concern within

one

year from the date this Quarterly Report on Form

-Q is filed with the U.S. Securities and Exchange Commission (“SEC”). The accompanying unaudited condensed consolidated financial statements do

not

include any adjustments relating to the recoverability of assets and classification of liabilities that might be necessary should we be unable to continue as a going concern.