On November 8, 2017 Eagle Pharmaceuticals, Inc. ("Eagle" or "the Company") (Nasdaq: EGRX) reported its financial results for the three- and nine-months ended September 30, 2017 (Press release, Eagle Pharmaceuticals, NOV 8, 2017, View Source [SID1234521738]). Highlights of and subsequent to the third quarter of 2017 include:

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Financial Highlights:

Total revenue for the third quarter of 2017 grew 67% to $63.0 million compared to $37.8 million in the third quarter of 2016;
Royalty revenue increased to $43.6 million compared to $26.2 million in Q3 2016;
Product sales decreased to $6.9 million compared to $7.8 million in Q3 2016;
Q3 2017 income before income tax provision was $24.5 million;
Q3 2017 net income was $15.4 million, or $1.03 per basic and $0.98 per diluted share, compared to a net income of $12.0 million, or $0.77 per basic and $0.73 per diluted share in Q3 2016;
Q3 2017 Adjusted Non-GAAP net income was $19.2 million, or $1.27 per basic and $1.22 per diluted share, compared to Adjusted Non-GAAP net income of $14.7 million, or $0.95 per basic and $0.89 per diluted share in the prior year quarter. For a full reconciliation of Adjusted Non-GAAP net income to the most comparable GAAP financial measures, please see the tables at the end of this press release; and,
Cash and cash equivalents were $97.5 million and accounts receivable were $71.6 million as of September 30, 2017.
Business and Recent Highlights:

BENDEKA total market share of 97%, as of September 30, 2017;
Sales of RYANODEX grew 29% to $3.3 million during the third quarter of 2017 compared to $2.5 million in Q3 2016;
Received tentative U.S. Food and Drug Administration (FDA) approval for PEMFEXY (pemetrexed injection) ready-to-dilute formulation;
Granted a new patent related to RYANODEX formulation (dantrolene sodium) by the United States Patent and Trademark Office, expiring June 2022;
Licensed Japanese rights for bendamustine hydrochloride ready-to-dilute and rapid infusion injection products to SymBio Pharmaceuticals Limited and received a $12.5 million upfront payment;
Announced positive results of an initial study in over 50 rodents to evaluate the neuroprotective effects of RYANODEX in an established rodent model of Nerve Agent-induced seizures and seizure-related brain damage;
Filed for a second source drug product manufacturing site for BENDEKA;
2017 R&D and SG&A guidance updated:
We expect our full year 2017 R&D expense will be consistent with the upper end of the $31-$35 million range. This reflects ongoing expenses for the enrollment of the fulvestrant and RYANODEX for Ecstasy and methamphetamine intoxication clinical trials. Excluding stock based compensation, the R&D expense would be in the range of $27 – $31 million.
We expect our full year SG&A expense to be in the range of $67 – $70 million, slightly higher than previous guidance. Excluding stock based compensation and other non-cash items, SG&A expense would be in the range of $53 – $56 million.
"This was another strong quarter for Eagle with record revenue driven by BENDEKA, a growing cash position and significant movement in our pipeline," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

"During the quarter, we advanced multiple pipeline candidates. We plan to begin dosing patients in our fulvestrant study in a few weeks and expect to file an NDA in the fourth quarter of 2018. With one dose, our formulation will deliver a 5mL solution, using a smaller needle and in less time than the current commercially available product. In addition, we received tentative approval from the FDA for PEMFEXY, our ready-to-dilute pemetrexed IV formulation. As the first company to receive tentative approval for this product using the 505(b)2 pathway, we hope to find a way to market as soon as possible, once our litigation with Eli Lilly is resolved," added Tarriff.

"We remain confident in our RYANODEX portfolio. We are continuing our dialogue with the FDA regarding EHS, while advancing our clinical work for the Ecstasy and methamphetamine, and nerve agent programs. We have also made progress on an intramuscular delivery formulation for RYANODEX, which we believe will provide patients and healthcare professionals with a valuable delivery option," Tarriff added.

"Eagle continues to generate strong cash flow, which allows us to invest in our pipeline, evaluate additional strategic opportunities and return capital to shareholders when it maximizes value. We have completed the first $75 million share repurchase program and will continue purchasing up to an additional $100 million shares under our current share repurchase plan, reflecting our belief in the potential of our products and pipeline," concluded Tarriff.

Third Quarter 2017 Financial Results

Total revenue for the three months ended September 30, 2017 was $63.0 million, as compared to $37.8 million for the three months ended September 30, 2016. A summary of total revenue is outlined below:

Three Months Ended September 30,
2017 2016

Revenue ($ in 000’s):
Product sales $ 6,905 $ 7,837
Royalty revenue 43,616 26,246
License and other income 12,500 3,750
Total revenue 63,021 37,833

Product sales decreased to $6.9 million driven by lower net product sales of BENDEKA and Argatroban, partially offset by an increase in net product sales of RYANODEX. Royalty revenue increased to $43.6 million, as a result of the increased market share on Teva sales of BENDEKA, as well as an increase in the royalty rate from 20% to 25%.

Research and development expenses increased to $9.0 million in the three months ended September 30, 2017, compared to $3.2 million in the prior year quarter. The increase is due to continued spending on the Company’s pipeline, and in particular, our fulvestrant, RYANODEX for Ecstasy and methamphetamine intoxication, and pemetrexed projects.

SG&A expenses increased to $16.7 million in the third quarter of 2017 compared to $11.7 million in the three months ended September 30, 2016. Personnel-related expenses grew as a result of the expansion of our sales force in the second quarter of 2017. External legal expenses also increased, due to ongoing litigation.

An income tax provision of $9.0 million was recorded during the third quarter of 2017.

Net income for the third quarter of 2017 was $15.4 million, or $1.03 per basic share and $0.98 per diluted share, compared to net income of $12.0 million, or $0.77 per basic and $0.73 per diluted share in the three months ended September 30, 2016, due to the factors discussed above.

Adjusted Non-GAAP net income for the third quarter of 2017 was $19.2 million, or $1.27 per basic and $1.22 per diluted share, compared to Adjusted Non-GAAP net income of $14.7 million or $0.95 per basic and $0.89 per diluted share in the prior year quarter. For a full reconciliation of Adjusted Non-GAAP net income to the most comparable GAAP financial measures, please see the tables at the end of this press release.

Liquidity

As of September 30, 2017, the Company had $48 million in net cash and cash equivalents and $72 million in net accounts receivable, $46 million of which was due from Teva. For the nine months ended September 30, 2017, net cash provided by operating activities, excluding the increase in net accounts receivable, was $62 million. The Company had $50 million in outstanding debt.

As part of our stock repurchase plan, we purchased $13.5 million worth of our shares during the quarter, completing our original $75 million share repurchase plan initiated in August 2016. We expanded the program by $100 million during the second quarter of 2017.

Conference Call

As previously announced, Eagle management will host its third quarter 2017 conference call as follows:

Date Wednesday, November 8, 2017
Time 8:30 A.M. EST
Toll free (U.S.) 866-518-6930
International 203-518-9797
Webcast (live and replay)
www.eagleus.com, under the "Investor Relations" section

A replay of the conference call will be available for one week after the call’s completion by dialing 800-839-8705 (US) or 402-220-6075 (International) and entering conference call ID EGRXQ317. The webcast will be archived for 30 days at the aforementioned URL.

On November 8, 2017 GlycoMimetics, Inc. (NASDAQ: GLYC) reported progress on its clinical development programs and its financial results for the third quarter and nine months ended September 30, 2017 (Press release, GlycoMimetics, NOV 8, 2017, View Source [SID1234521739]).

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The Company will host a conference call and webcast to provide a corporate update and report its third-quarter 2017 financial results today at 8:30 a.m. ET. The dial-in number for the conference call is (844) 413-7154 for domestic participants and (216) 562-0466 for international participants with participant code 8794188. A webcast replay will be available via the "Investors" tab on the GlycoMimetics website for 30 days following the call. A dial-in phone replay will be available for 24 hours after the close of the call by dialing (855) 859-2056, participant code 8794188.

"In the third quarter of 2017, we initiated productive discussions with the FDA to review data emerging from the ongoing Phase 1/2 clinical trial of our specific E-selectin inhibitor product candidate, GMI-1271, for the treatment of acute myeloid leukemia (AML) and to plan a mid-2018 start of the Phase 3 trial. The discussions reflect the FDA’s granting of Breakthrough Therapy designation to GMI-1271 for the treatment of relapsed/refractory AML patients. Our focus is on finalizing the design of the registrational trial in relapsed/refractory disease. While in the near term we are preparing to provide an update on the GMI-1271 program via two oral presentations at the ASH (Free ASH Whitepaper) meeting, we also continue to make progress across our clinical pipeline and in the preclinical arena," stated Rachel King, Chief Executive Officer.

Key Operational Highlights for the Third Quarter of 2017:

GlycoMimetics engaged with the FDA under the terms of the Breakthrough Therapy designation the Company received in May. Discussions are focused on the design of a Phase 3 clinical trial protocol, including appropriate endpoints to capture GMI-1271’s potential benefits and a plan for other aspects of the program required for registration.
Data related to GMI-1271 will be highlighted in two oral presentations at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Expo. The ASH (Free ASH Whitepaper) meeting will take place in Atlanta, GA, December 9-12, 2017. The oral presentations at the ASH (Free ASH Whitepaper) meeting will include results from the ongoing Phase 1/2 clinical trial of GMI-1271, as well as a preclinical study in which the mechanism by which E-selectin mediates resistance to chemotherapy was observed. In the Phase 1/2 clinical trial, improved clinical outcomes were seen in both relapsed/refractory and newly diagnosed AML patients following treatment with GMI-1271. The preclinical data point to E-selectin dependent upregulation of tumor survival pathways, which are inhibited by GMI-1271.
The rivipansel Phase 3 trial, being conducted by the Company’s collaborator Pfizer, is evaluating patients hospitalized for vaso-occlusive crisis of sickle cell disease. Pfizer reports that the study remains on track for completion in the second half of 2018.
Third Quarter 2017 Financial Results:

Cash position: As of September 30, 2017, GlycoMimetics had cash and cash equivalents of $112.9 million as compared to $40.0 million as of December 31, 2016. The Company raised $86.8 million in net proceeds from a public offering of common stock completed in May 2017. Subsequent to September 30, the Company raised an additional $19.2 million in net proceeds under an at-the-market equity facility, resulting in a pro forma cash balance of $132.1 million as of September 30.
R&D Expenses: The Company’s research and development expenses decreased slightly to $5.8 million for the quarter ended September 30, 2017 as compared to $5.9 million for the third quarter of 2016. The decrease was primarily caused by lower clinical trial expenses related to the Phase 1/2 clinical trial of GMI-1271 for the treatment of AML due to patient enrollment completion in May 2017 and a decrease in costs for non-clinical toxicology studies and clinical studies for GMI-1359. These decreases were offset in part by additional costs related to the manufacturing of Phase 3 clinical supplies of GMI-1271.
G&A Expenses: The Company’s general and administrative expenses increased to $2.4 million for the quarter ended September 30, 2017 as compared to $2.0 million for the third quarter of 2016. These increases were primarily attributable to annual salary adjustments and stock-based compensation expense from 2017 equity awards to employees and directors.
Shares Outstanding: Shares of common stock outstanding as of September 30, 2017 were 32,737,799.
About GMI-1271

GMI-1271 is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. In a Phase 1/2 clinical trial that has now completed enrollment, GMI-1271 is being evaluated in both newly diagnosed elderly and relapsed/refractory patients with acute myeloid leukemia (AML). In both populations in this trial, patients treated with GMI-1271 together with standard chemotherapy have achieved higher than expected remission rates based on historical controls, as well as lower than expected induction-related mortality rates. Importantly, treatment in these patient populations has been well tolerated with minimal adverse effects.

About GMI-1359

GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. Since E-selectin and CXCR4 are both adhesion molecules that keep cancer cells in the bone marrow, the Company believes that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of both liquid and solid tumors that affect the bone marrow, as compared to targeting CXCR4 alone. GMI-1359 is currently being evaluated in a Phase 1 clinical trial.

About Rivipansel

Rivipansel, a pan-selectin antagonist, is being developed for the treatment of vaso-occlusive crisis (VOC) in sickle cell disease and is being evaluated in a Phase 3 clinical trial being conducted by GlycoMimetics’ strategic collaborator, Pfizer. Sickle cell disease is a genetic disease that, according to the U.S. Centers for Disease Control and Prevention, affects millions of people throughout the world, including an estimated 90,000 to 100,000 people in the United States. VOC is one of the most severe complications of sickle cell disease.

On November 8, 2017 Ophthotech Corporation (Nasdaq: OPHT) reported financial and operating results for the third quarter ended September 30, 2017 and provided a business update (Press release, Ophthotech, NOV 8, 2017, View Source [SID1234521757]).

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"We are very excited to update you on the expansion of our age related and orphan retina programs with our complement C5 inhibitor, Zimura," stated Glenn P. Sblendorio, Chief Executive Officer and President of Ophthotech. "Scientific literature continues to strengthen our belief in the potential role of complement C5 inhibition in the treatment of retinal diseases. We have progressed in all of our clinical programs by initiating new trials and modifying a current clinical trial. We remain on track to have four trials ongoing by the end of the year."

Zimura Complement Factor C5 Inhibitor Program

•
Geographic Atrophy, a severe form of Dry Age-related Macular Degeneration: Ophthotech has modified its on-going Zimura (avacincaptad pegol) clinical trial for the treatment of geographic atrophy (GA) secondary to dry age related macular degeneration (AMD). This on-going randomized, double-masked, sham controlled Phase 2b clinical trial is designed to assess the safety and efficacy of Zimura monotherapy in patients with GA. The Company has modified the design of the trial to accelerate the anticipated timeline for obtaining top-line data. The Company has reduced the number of patients it plans to enroll in this trial to approximately 200 and has shortened the time point for attaining the primary efficacy endpoint to 12 months. The number of sites has been expanded within the United States and globally to expedite enrollment. The primary efficacy endpoint is the mean rate of change in GA over 12 months. Patients will be treated and monitored for 18 months. The modified study design incorporates patients that were already enrolled in the study prior to these modifications. A range of Zimura dosing regimens will also be assessed. The Company submitted a modified Phase 2b clinical trial protocol to the U.S. Food and Drug Administration (FDA) early in the fourth quarter of 2017. Initial, top-line data is expected to be available during the second half of 2019.

•
Wet Age-related Macular Degeneration: During the third quarter of 2017, the Company initiated a new dose-ranging, open-label Phase 2a clinical trial of Zimura in combination with Lucentis in patients with wet AMD who have not been previously treated with any anti-VEGF agents. Approximately 60 patients will be enrolled and

treated for a duration of 6 months. Based on the anticipated enrollment rate, the Company expects initial top-line data from this trial to be available by the end of 2018.

•
Idiopathic Polypoidal Choroidal Vasculopathy: The Company plans to initiate before year end an open-label Phase 2a clinical trial evaluating Zimura in combination with Eylea for the treatment of idiopathic polypoidal choroidal vasculopathy (IPCV) in treatment experienced patients. Approximately 20 patients will be enrolled and treated for a duration of 9 months. Initial top-line data is expected to be available during the second half of 2019.

Ophthalmic Orphan Disease Program

•
Autosomal Recessive Stargardt Disease: Ophthotech remains on track to initiate a Phase 2b randomized, double masked, sham controlled clinical trial in autosomal recessive Stargardt disease (STGD1) before the end of this year. This trial will assess the safety and efficacy of Zimura monotherapy in patients with STGD1, an inherited orphan retinal disease causing vision loss during childhood or adolescence. There are currently no FDA or EMA approved treatments available for STGD1 and it remains a significant unmet medical need. The Company expects to enroll approximately 120 patients in this trial, making it one of the largest interventional clinical trials in Stargardt disease to date. The Company plans to use an anatomic endpoint as measured by spectral domain optical coherence tomography (SD-OCT) as the primary endpoint, which will be assessed at 18 months. Initial top-line data is expected to be available in 2020.

Third Quarter 2017 Financial Highlights

•
Cash Position: As of September 30, 2017, the Company had $180.2 million in cash and cash equivalents. The Company expects a 2017 year end cash balance of between $155 million and $165 million, excluding any potential business development activities, and including the approximately $5 million to $7 million that remains committed to implementing a reduction in personnel and winding-down the Fovista (pegpleranib) in combination with Eylea or Avastin clinical trial.

•
Revenues: Collaboration revenue was $206.7 million for the quarter ended September 30, 2017, compared to $1.7 million for the same period in 2016. For the nine months ended September 30, 2017, collaboration revenue was $210 million, compared to $45.6 million for the same period in 2016. Collaboration revenue increased in both the quarter and nine months ended September 30, 2017 as the Company completed all deliverables required under its licensing and commercialization agreement with Novartis Pharma AG and recognized all associated deferred revenue. This increase in collaboration revenue had no impact on the Company’s cash balance.

•
R&D Expenses: Research and development expenses were $10.7 million for the quarter ended September 30, 2017, compared to $50.9 million for the same period in 2016. For the quarter ended September 30, 2017, research and development expenses included approximately $0.9 million in costs related to the Company’s previously announced reduction in personnel. For the nine months ended September 30, 2017, research and development expenses were $58.3 million, compared to $136.9 million for the same period in 2016. For the nine months ended September 30,

2017, research and development expenses included approximately $6.8 million in costs related to the Company’s previously announced reduction in personnel. Research and development expenses decreased in both the quarter and nine months ended September 30, 2017 primarily due to a decrease in expenses related to the Company’s Fovista Phase 3 clinical program, including a decrease in manufacturing activities.

•
G&A Expenses: General and administrative expenses were $7.1 million for the quarter ended September 30, 2017, compared to $12.0 million for the same period in 2016. For the quarter ended September 30, 2017, general and administrative expenses included approximately $0.5 million in costs related to the Company’s previously announced reduction in personnel. For the nine months ended September 30, 2017, general and administrative expenses were $28.8 million, compared to $37.2 million for the same period in 2016. For the nine months ended September 30, 2017, general and administrative expenses included approximately $5.1 million in costs related to the Company’s previously announced reduction in personnel and its termination of facilities leases. General and administrative expenses decreased in both the quarter and nine months ended September 30, 2017 primarily due to a decrease in costs to support the Company’s operations and infrastructure.

•
Net Income: The Company reported net income for the quarter ended September 30, 2017 of $189.1 million, or $5.25 per diluted share, compared to a net loss of $60.9 million, or ($1.71) per diluted share, for the same period in 2016. For the nine months ended September 30, 2017, the Company reported net income of $123.7 million, or $3.44 per diluted share, compared to a net loss of $127.1 million, or ($3.59) per diluted share, for the same period in 2016.

Conference Call/Web Cast Information
Ophthotech will host a conference call/webcast to discuss the Company’s financial and operating results and provide a business update. The call is scheduled for November 8, 2017 at 8:00 a.m. Eastern Time. To participate in this conference call, dial 800-239-9838 (USA) or +1 323-794-2551 (International), passcode 7300213. A live, listen-only audio webcast of the conference call can be accessed on the Investor Relations section of the Ophthotech website at: www.ophthotech.com. A replay will be available approximately two hours following the live call for two weeks. The replay number is 888-203-1112 (USA Toll Free), passcode 7300213

On November 8, 2017 Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) reported consolidated financial results for the third quarter ended September 30, 2017 (Press release, Pacira Pharmaceuticals, NOV 8, 2017, View Source;991.htm [SID1234521758]).

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"We continue to make important progress during 2017 as we advance our strategy to expand the role of EXPAREL as the only long-acting local analgesic capable of providing non-opioid pain control during the most intense period of postsurgical pain," said Dave Stack, chairman and chief executive officer of Pacira. "Recent highlights include the FDA acceptance of our sNDA for nerve block; the publication of new research quantifying the devastating impact of opioids for postsurgical pain; a unique collaboration with Aetna to reduce opioid use associated with impacted wisdom teeth extractions; and the advancement of our important partnership with J&J."

"During the quarter we generated year over year EXPAREL growth despite fewer selling days and the impact of weather in areas of the southern United States representing about 20 percent of our business. From our commercial initiatives and current trends however; we remain confident in the growth potential of EXPAREL and our steadfast commitment to reducing the use of opioids for postsurgical pain."

Recent Highlights

•
U.S. Food and Drug Administration (FDA) Acceptance of Supplementary New Drug Application for Nerve Block. In October, the FDA accepted the company’s resubmission of its supplemental new drug application (sNDA) seeking expansion of the EXPAREL (bupivacaine liposome injectable suspension) label to include administration via nerve block for prolonged regional analgesia. If approved, EXPAREL could help eliminate the need for cumbersome devices like pumps and catheters and shift numerous procedures to an outpatient setting. The expected action date for the FDA under the Prescription Drug User Fee Act (PDUFA) is April 6, 2018.

•
Provided Invited Testimony at White House Opioid Crisis Commission Meeting. In September, Pacira Chief Executive Officer Dave Stack testified before President Trump’s Commission on Combating Drug Addiction and the Opioid Crisis. The Commission, led

by New Jersey Governor Chris Christie, was created to study ways to combat and treat drug abuse, addiction and the opioid crisis. Stack provided insights into the critical nature of clinician and patient access to non-opioid medications that can effectively manage postsurgical pain while reducing opioid requirements.

•
Published New Research Highlighting Serious Threats Associated with Overprescribing Postsurgical Opioids. Newly published research, conducted by the QuintilesIMS Institute, shows individuals undergoing surgery are at particular risk for long-term opioid use. An overwhelming majority of patients (nine in 10) are exposed to opioids to manage postsurgical pain, and those given prescriptions received an average of 85 pills each. In addition, nearly 3 million individuals who had surgery in 2016 became persistent opioid users, according to the research. This report, The United States for Non-Dependence, represents the most current analysis of national trends in opioid prescribing.

•
Collaboration with Aetna and the American Association of Oral and Maxillofacial Surgeons to Reduce Opioid Use. In September, Pacira announced a nationwide collaboration with Aetna and the American Association of Oral and Maxillofacial Surgeons (AAOMS) aimed at reducing the number of opioid tablets prescribed to patients undergoing impacted third molar extraction by at least 50 percent through the utilization of EXPAREL to provide prolonged non-opioid postsurgical pain control.

•
Multiple EXPAREL Data Presentations at the New York School of Regional Anesthesia Annual Fall Symposium. In September, the company presented three posters evaluating the use of EXPAREL administered as a regional nerve block to manage postsurgical pain at the New York School of Regional Anesthesia’s (NYSORA) 16th Annual Symposium on Regional Anesthesia, Pain and Perioperative Medicine.

Third Quarter 2017 Financial Results

•
EXPAREL net product sales were $66.8 million in the third quarter of 2017, a 3% increase over the $64.9 million reported for the third quarter of 2016. There were two fewer selling days in the third quarter of 2017 compared to the third quarter of 2016.

•
Total revenues were $67.3 million in the third quarter of 2017, a 1% decrease versus the $68.4 million reported for the third quarter of 2016, primarily related to the discontinuation of DepoCyt(e) and lower collaborative licensing and milestone revenue.

•
Total operating expenses were $70.9 million in the third quarter of 2017, compared to $89.2 million in the third quarter of 2016.

•
GAAP net loss was $7.6 million, or $(0.19) per share (basic and diluted), in the third quarter of 2017, compared to a GAAP net loss of $22.2 million, or $(0.59) per share (basic and diluted), in the third quarter of 2016.

•
Non-GAAP net income was $4.4 million, or $0.11 per share (basic and diluted) in the third quarter of 2017, compared to non-GAAP net income of $8.0 million, or $0.22 per share (basic) and $0.20 per share (diluted), in the third quarter of 2016.

•
Pacira ended the third quarter of 2017 with cash, cash equivalents, short-term and long-term investments ("cash") of $374.9 million.

•
Pacira had 40.5 million basic weighted average shares of common stock outstanding in the third quarter of 2017.

•
For non-GAAP measures, Pacira had 41.4 million diluted weighted average shares of common stock outstanding in the third quarter of 2017.

2017 Outlook

Pacira is updating its full year 2017 sales guidance and reiterating its remaining financial guidance as follows:

•
EXPAREL net product sales of $280 million to $285 million from its previously guided range of $290 million to $310 million.

•
Non-GAAP gross margins of approximately 70%.

•
Non-GAAP research and development (R&D) expense of $50 million to $60 million.

•
Non-GAAP selling, general and administrative (SG&A) expense of $145 million to $155 million.

•
Stock-based compensation of $30 million to $35 million.

See "Non-GAAP Financial Information" and "Reconciliations of GAAP to Non-GAAP 2017 Financial Guidance" below.

Today’s Conference Call and Webcast Reminder

The Pacira management team will host a conference call to discuss the company’s financial results and recent developments today, Wednesday, November 8, 2017, at 8:30 a.m. ET. The call can be accessed by dialing 1-877-845-0779 (domestic) or 1-720-545-0035 (international) ten minutes prior to the start of the call and providing the Conference ID 96590192.

A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing 1-855-859-2056 (domestic) or 1-404-537-3406 (international) and providing the Conference ID 96590192. The replay of the call will be available for two weeks from the date of the live call.

The live, listen-only webcast of the conference call can also be accessed by visiting the "Investors & Media" section of the company’s website at investor.pacira.com. A replay of the webcast will be archived on the Pacira website for two weeks following the call.

Non-GAAP Financial Information

This press release contains financial measures that do not comply with U.S. generally accepted accounting principles (GAAP), such as non-GAAP net income (loss), non-GAAP cost of goods sold, non-GAAP gross margins, non-GAAP research and development (R&D), non-GAAP selling, general and administrative (SG&A) and non-GAAP product discontinuation expenses, because such measures exclude stock-based compensation, amortization of debt discount, loss on early extinguishment of debt, a contract termination fee with CrossLink BioScience, LLC, or CrossLink, exit costs related to the discontinuation of DepoCyt(e) production and inventory and related reserves from 2016.

These measures supplement the company’s financial results prepared in accordance with GAAP. Pacira management uses these measures to better analyze its financial results, estimate its future cost of goods sold, gross margins, R&D and SG&A outlook for 2017 and to help make managerial decisions. In management’s opinion, these non-GAAP measures are useful to investors and other users of our financial statements by providing greater transparency into the operating performance at Pacira and the company’s future outlook. Such measures should not be deemed to be an alternative to GAAP requirements or a measure of liquidity for Pacira. Non-GAAP measures are also unlikely to be comparable with non-GAAP disclosures released by other companies. See the tables below for a reconciliation of GAAP to non-GAAP measures, and a reconciliation of our GAAP to non-GAAP 2017 financial guidance for gross margins, R&D and SG&A.

On November 8, 2017 Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx, reported its financial results for the nine months ended September 30, 2017 and provided a corporate update (Press release, Protalix, NOV 8, 2017, View Source;p=RssLanding&cat=news&id=2315313 [SID1234521760]).

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"I am excited about the progress we made recently," said Moshe Manor, Protalix’s President and Chief Executive Officer. "We are no longer facing any debt issue or financing overhang. Moreover, with the recent strategic collaboration with Chiesi, not only did we secure a strong, experienced clinical and commercial partner, but we also meaningfully increased our capital resources, providing us with sufficient cash into 2020, irrespective of any milestone payments we are entitled to from Chiesi, increased revenues or from future partnerships. In addition, on the strategic front, we now have three novel and clinically differentiated product candidates in the clinic with potentially superior efficacy which provides us multiple shots at goal to realize significant value for our stockholders."

Third Quarter and Recent Clinical Highlights

Pegunigalsidase alfa (PRX-102) for Fabry Disease

Protalix entered into an EX-US collaboration agreement with Chiesi Farmaceutici S.p.A., or Chiesi, for pegunigalsidase alfa, or PRX-102. Under the terms of the agreement, Protalix is entitled to an upfront payment of $25 million from Chiesi, up to $25 million to cover development costs for pegunigalsidase alfa, subject to a maximum of $10 million per year, and up to an additional $320 million in regulatory and commercial milestone payments. Additionally, Protalix is entitled to tiered payments of 15% to 35% of Chiesi’s net sales.

Patient enrollment in the Company’s phase III clinical trials, referred to as the Balance, Bridge and Bright studies, is on-going.
Alidornase alfa (PRX-110) for Cystic Fibrosis

Protalix applied for a financial grant from the Cystic Fibrosis Foundation to support the clinical development of alidornase alfa.

A poster titled "Development of Novel Actin Inhibition Resistant DNase I Enzyme – alidornase alfa – for the Treatment of Cystic Fibrosis" was presented at the North American Cystic Fibrosis Conference held in November 2017.
Oral antiTNF (OPRX-106) for Ulcerative Colitis

The final patients needed to complete enrollment in the Company’s phase II clinical trial of OPRX-106 for the treatment of ulcerative colitis are in the screening process. The Company remains on track to complete enrollment during the fourth quarter and report top-line results in early 2018.
Alfataliglicerase for Gaucher Disease

Shipment of approximately $3.0 million of alfataliglicerase was completed this quarter for a total of $6.6 million for the nine months ended September 30, 2017.

According to the purchase order received by the Company, additional shipments are scheduled to be made during fourth quarter of 2017, and into 2018.
Financial Results for Nine Months ended September 30, 2017

The Company reported a net loss of $32.1 million, or $0.25 per share, basic and diluted, for the nine-month period ended September 30, 2017, excluding a one-time, non-cash net charge of $38.1 million in connection with the remeasurement of a derivative, compared to a net loss of $26.7 million, or $0.27 per share, basic and diluted, for the same period of 2016.

The Company recorded total revenues of $16.8 million for the nine-month period ended September 30, 2017, compared to $7.1 million during the same period of 2016. The increase is primarily the result of increased sales of drug product to Brazil of $6.6 million in the nine months ended September 30, 2017, compared to $2.7 million in the same period of 2016, and the sale of drug substance to Pfizer Inc.

Research and development expenses, net were $19.8 million for the nine-month period ended September 30, 2017, compared to $18.9 million for the same period of 2016. Selling, general and administrative expenses were $8.2 million for the nine-month period ended September 30, 2017, compared to $6.2 million incurred during the same period of 2016. The increases are primarily attributed to increased activities in three ongoing clinical trials and selling in Brazil.

During the nine-month period ended September 30, 2017 and during October, note holders converted the entire $8.55 million in aggregate principal amount of the Company’s 4.50% convertible notes due 2022.

As of today, the Company’s outstanding convertible notes include 4.50% convertible notes due September 2018 with an aggregate principal amount of $5.9 million and senior secured 7.50% convertible notes due November 2021 with an aggregate principal amount of $61.9 million.

On September 30, 2017, the Company had $33.4 million of cash and cash equivalents. With the Company’s current cash, plus the additional $25 million upfront payment due from Chiesi, and without giving effect to any milestone payment we are entitled to from Chiesi, anticipated increase in revenue run rate or any additional potential partnerships, the Company has sufficient resources to fund operations into 2020.
Conference Call and Webcast Information

The Company will host a conference call on Wednesday, November 8, 2017, at 8:30 am ET to review the clinical, corporate and financial highlights.

To participate in the conference call, please dial the following numbers prior to the start of the call: United States: (844) 358-6760; International: (478) 219-0004. Conference ID number 6767278.

The conference call will also be broadcast live and available for replay for two weeks on the Company’s website, www.protalix.com, in the Events Calendar of the Investors section. Please access the Company’s website at least 15 minutes ahead of the conference to register, download, and install any necessary audio software.