On November 1, 2018 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported operating results for third-quarter 2018 and provided an update on the Company’s commercial products and development programs (Press release, TESARO, NOV 1, 2018, View Source [SID1234530565]).

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"In the third quarter, we launched several initiatives to grow the use of ZEJULA for recurrent ovarian cancer and we continued to execute on our development strategies focused on gynecologic and lung cancers as we approach a period of significant data readouts," said Lonnie Moulder, CEO of TESARO. "Following results of the Phase 3 PRIMA trial next year, we intend for ZEJULA to benefit patients throughout all stages of their ovarian cancer journey, including first-line, recurrent, and late-line treatment settings. Our immuno-oncology pipeline continues to advance, led by our anti-PD-1 antibody, TSR-042, for which we are on track to submit a BLA next year. We look forward to initial data from the Phase 1 AMBER trial of our anti-TIM-3 antibody, TSR-022, in combination with TSR-042, which will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting next week."

Recent Business Highlights

ZEJULA net revenue increased 61% year-over-year to $63.2 million for the third quarter of 2018. In the U.S. and Europe, approximately 10,000 patients have been treated with ZEJULA since its launch in April 2017. ZEJULA is now approved in 33 countries and is reimbursed and launched in Germany, the U.K., Italy and several other European countries.
Safety data were presented from the Phase 3 PRIMA trial of ZEJULA monotherapy in first-line ovarian cancer during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress in October. Data demonstrated a favorable tolerability profile for niraparib when dosed according to a patient’s weight and platelet count compared to a fixed starting dose. The PRIMA Phase 3 trial is fully enrolled and top-line results are expected in late 2019.
Based upon the responses observed in the first stage of the study, the second stage of the Phase 2 JASPER study was initiated, which evaluates ZEJULA in combination with TSR-042 as a first-line treatment for patients with non-small cell lung cancer and high levels of PD-L1 expression.
Data were presented from the GARNET trial of TSR-042 monotherapy at ESMO (Free ESMO Whitepaper) and demonstrated TSR-042 is well tolerated and has robust clinical activity in patients with MSI-H endometrial cancer.
Zai Lab Limited announced ZEJULA approval in Hong Kong on October 22, 2018. ZEJULA is the first and only PARP inhibitor approved in Hong Kong for the maintenance treatment of platinum-sensitive relapsed ovarian cancer regardless of BRCA mutation status.
In October, TESARO and actress Cobie Smulders launched Not on My Watch, a national movement to empower the ovarian cancer community, especially women with recurrent ovarian cancer, to take informed and proactive steps against the threat of disease recurrence.
Development milestones were achieved in October related to Janssen’s ongoing GALAHAD trial of niraparib monotherapy for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) and DNA-repair anomalies. The achievement of these milestones triggered an $18 million payment from Janssen to TESARO.
Third Quarter 2018 Financial Results

TESARO reported net product revenue of $63.6 million for the third quarter of 2018, compared to a total of $41.8 million for the third quarter of 2017. ZEJULA net revenue increased 61% to $63.2 million for the third quarter of 2018, compared to $39.4 million for the third quarter of 2017. Cost of goods sold increased to $14.2 million for the third quarter of 2018, compared to $6.2 million for the same period in 2017, primarily related to increased volume and new supplier set-up expenses.

Research and development expenses increased to $94.2 million for the third quarter of 2018, compared to $73.4 million for the third quarter of 2017, driven primarily by higher manufacturing and clinical development costs associated with TSR-042, TSR-022, and ZEJULA, and research collaborations.

Selling, general and administrative expenses increased to $93.5 million for the third quarter of 2018, compared to $84.0 million for the third quarter of 2017, primarily due to increased headcount and activities in support of the launches of ZEJULA in the U.S. and Europe.

Operating expenses as described above include total non-cash, stock-based compensation expense of $24.8 million for the third quarter of 2018, compared to $25.0 million for the third quarter of 2017.

Net loss totaled $137.1 million, or ($2.49) per share, for the third quarter of 2018, compared to a net loss of $25.3 million, or ($0.47) per share, for the third quarter of 2017. The increase in net loss was primarily due to the $100.0 million up-front payment received and recorded as revenue in the third quarter of 2017 as part of the license agreement with Takeda, partially offset by a $17.6 million gain in the third quarter of 2018 associated with the divestiture of VARUBI in the U.S., for which TESARO received an up-front payment of $35 million.

(in thousands, except per share amounts) Three Months Ended
September 30,
2018
2017

Product revenue, net
ZEJULA $ 63,226 $ 39,375
VARUBI/VARUBY $ 386 $ 2,380
Total product revenue, net $ 63,612 $ 41,755
License, collaboration, and other revenue $ 787 $ 101,011
Total revenues $ 64,399 $ 142,766

Net loss $ (137,088 ) $ (25,277 )

Net loss per share, basic and diluted $ (2.49 ) $ (0.47 )

(in thousands) Three Months Ended
September 30,
2018 2017
Cost of sales – product $ 14,225 $ 6,216
Cost of sales – intangible asset amortization $ 728 $ 1,254
Research and development (R&D) $ 94,188 $ 73,388
Selling, general and administrative (SG&A) $ 93,497 $ 83,998
Acquired in-process R&D $ - $ -
Cash and Cash Equivalents

As of September 30, 2018, TESARO had approximately $476.8 million in cash and cash equivalents and approximately 55.0 million outstanding shares of common stock.

2018 Financial Guidance

TESARO is updating its 2018 financial guidance for ZEJULA:

Total Revenue, net, worldwide (FY) $258 to $265 million
(previously $250 to $265 million)
ZEJULA (FY) $233 to $238 million
(previously $225 to $235 million)
ZEJULA (Q4) $67 to $72 million
Other revenue, including licensing and
VARUBY oral (FY) $25 to $27 million
(previously $25 to $30 million)
Interest expense (FY) Approximately $60 million,
including non-cash interest expense of $14 million
In the third quarter, TESARO’s cash and cash equivalents balance declined by approximately $98 million. TESARO anticipates year-end 2018 cash and cash equivalents to be approximately $400 million.

Key Development Milestones

Gynecologic Cancers:

Submit QUADRA sNDA for treatment of late-line ovarian cancer beyond BRCAmut near year-end
Results of the AVANOVA Phase 2 study of ZEJULA in combination with bevacizumab for treatment of recurrent ovarian cancer to be submitted for presentation at a medical meeting in 1H 2019
Report Phase 2 OVARIO results of ZEJULA in combination with bevacizumab in first-line ovarian cancer maintenance in late 2019
Report Phase 3 PRIMA results of ZEJULA in first-line ovarian cancer maintenance in late 2019
Lung Cancer:

Report initial data for the AMBER trial of TSR-022 in combination with TSR-042 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) Annual Meeting on November 9
Report additional data from the NSCLC cohort of the GARNET trial of TSR-042 at SITC (Free SITC Whitepaper)
Initiate Phase 2 registration enabling trial of TSR-042 versus standard of care in first-line NSCLC in early 2019
Report additional data from the Phase 2 JASPER study of ZEJULA in combination with anti-PD-1 at a medical meeting in 1H 2019
Breast Cancer:

Submit BRAVO data for ZEJULA in germline BRCAmut breast cancer patients for publication in Q4 2018
Complete protocol development for registration study of ZEJULA in combination with TSR-042 and other agents in breast cancer
Prostate Cancer:

Janssen to advance GALAHAD trial of ZEJULA in mCRPC and DNA-repair anomalies to support global regulatory filings in 2019
Planning underway by Janssen for a future Phase 3 trial that will assess the clinical benefit of niraparib in combination with abiraterone acetate + prednisone in mCRPC patients
Immuno-oncology Pipeline:

Continue dose-escalation in the CITRINO trial (combination of TSR-033 plus TSR-042) and report Phase 1 monotherapy dose-escalation data for TSR-033 at SITC (Free SITC Whitepaper)
Advance IND-enabling studies of PD-1/LAG-3 bi-specific antibody (TSR-075)
Today’s Conference Call and Webcast

TESARO will host a conference call to discuss the Company’s third quarter operating results and provide an update on the Company’s commercial products and development programs today at 4:15 P.M. Eastern time. The accompanying slide presentation and live webcast of the conference call can be accessed by visiting the TESARO website at www.tesarobio.com. The call can be accessed by dialing (877) 853-5334 (U.S. and Canada) or (970) 315-0307 (international). A replay of the webcast will be archived on the Company’s website for 30 days following the call.

About ZEJULA (niraparib)

ZEJULA (niraparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. In preclinical studies, ZEJULA concentrates in the tumor relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumor effect. Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including some fatal cases, was reported in patients treated with ZEJULA. Discontinue ZEJULA if MDS/AML is confirmed. Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia), as well as cardiovascular effects (hypertension and hypertensive crisis) have been reported in patients treated with ZEJULA. Monitor complete blood counts to detect hematologic adverse reactions, as well as to detect cardiovascular disorders, during treatment. ZEJULA can cause fetal harm and females of reproductive potential should use effective contraception. Please see full prescribing information, including additional important safety information, available at www.zejula.com.

On November 1, 2018 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated therapeutics targeting the underlying mechanisms of cancer, reported that preclinical data for its pan-FLT3/pan-BTK inhibitor CG-806 will be presented in two separate posters at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition being held December 1-4, 2018 in San Diego, CA (Press release, Aptose Biosciences, NOV 1, 2018, View Source [SID1234530564]).

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The abstracts accepted for presentation are listed below and can be viewed online at the ASH (Free ASH Whitepaper) conference website.

CG-806 Poster Presentation Details

CG-806, a First-in-Class Pan-FLT3/Pan-BTK Inhibitor, Exhibits Broader and Greater Potency Than Ibrutinib Against Primary and Cultured Malignant B Cells

Date & Time: Sunday December 2, 2018, 6:00-8:00 PM PT
Session Name: 802. Chemical Biology and Experimental Therapeutics: Poster II
Abstract Number: 3503
Location: San Diego Convention Center, Hall GH

Concomitant Targeting of FLT3 and BTK with CG-806 Overcomes FLT3-Inhibitor Resistance Through Inhibition of Autophagy

Date & Time: Sunday December 2, 2018, 6:00-8:00 PM PT
Session Name: 604. Molecular Pharmacology and Drug Resistance in Myeloid Diseases: Poster II
Abstract Number: 2635
Location: San Diego Convention Center, Hall GH

About CG-806

CG-806 is a preclinical stage oral, first-in-class pan-FLT3/pan-BTK multi-cluster kinase inhibitor. This small molecule demonstrates potent inhibition of wild type and all mutant forms of FLT3 (including internal tandem duplication, or ITD, and mutations of the receptor tyrosine kinase domain and gatekeeper region), eliminates acute myeloid leukemia (AML) tumors in the absence of toxicity in murine xenograft models, and represents a potential best-in-class therapeutic for patients with AML. Likewise, CG-806 demonstrates potent, non-covalent inhibition of the wild type and Cys481Ser mutant forms of the BTK enzyme, as well as other oncogenic kinase pathways operative in B cell malignancies, suggesting CG-806 may be developed for various B cell malignancy patients (including CLL, MCL, DLBCL and others) that are resistant/refractory/intolerant to covalent BTK inhibitors.

On November 1, 2018 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported financial results for the third quarter ended September 30, 2018 (Press release, Curis, NOV 1, 2018, View Source [SID1234530550]).

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"Following Curis’s recent leadership change, we are increasing our focus on the clinical execution of our three first-in-class therapeutics that have the potential to be significant and innovative cancer treatments. We expect all three drug candidates to progress rapidly in the clinic and have data readouts in 2019," said James Dentzer, President & Chief Executive Officer of Curis. "To achieve this goal, we are re-allocating resources to prioritize clinical operations and have implemented a reduction in headcount and expenditure on pre-clinical science, pipeline expansion, and general and administrative expenses. We expect these reductions will offset an increase in headcount and costs associated with clinical operations and result in net savings for the Company, reducing cash burn from approximately $11 million to $8 million per quarter. This renewed focus on clinical execution will benefit patients in need of life-changing medications and shareholders alike," Mr. Dentzer concluded.

Third Quarter 2018 Financial Results

Curis reported a net loss of $7.2 million, or $0.22 per share on a basic and diluted basis for the third quarter of 2018, as compared to a net loss of $15.5 million, or $0.53 per share respectively for the same period in 2017.

Revenues for the third quarter of 2018 were $2.8 million, as compared to $2.4 million for the same period in 2017. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge.

Operating expenses were $9.3 million for the third quarter of 2018, as compared to $16.9 million for the same period in 2017, and comprised the following:

Costs of Royalty Revenues. Costs of royalty revenues, resulting from payments to third-party university patent licensors associated with Genentech and Roche’s Erivedge net sales, were $0.2 million as compared to $0.1 million for the same period in 2017.

Research and Development Expenses. Research and development expenses were $5.0 million, as compared to $13.4 million for the same period in 2017. The decrease was primarily driven by decreased costs related to clinical activities and manufacturing for fimepinostat, CA-170 and CA-4948 and a payment to Aurigene of $3.8 million for an exclusivity option in September 2017.

General and Administrative Expenses. General and administrative expenses were $4.1 million as compared to $3.4 million for the same period in 2017. The increase in general and administrative expenses was primarily driven by higher personnel costs and professional and consulting services partially offset by lower stock-based compensation for the period.

Other Expenses. Net other expenses totaled $0.8 million as compared to $1.0 million for the same period in 2017. Net other expense primarily consisted of interest expense related to Curis Royalty’s (a wholly owned subsidiary of Curis) debt obligations.

As of September 30, 2018, Curis’s cash, cash equivalents and investments totaled $30.8 million and there were approximately 33.1 million shares of common stock outstanding.

Recent Operational Highlights

Precision oncology, fimepinostat (formerly CUDC-907):

Having received Fast Track designation for fimepinostat, Curis is working with the FDA and select clinical sites to initiate a combination study of fimepinostat (a MYC inhibitor) with venetoclax (a BCL-2 inhibitor) in DLBCL, including patients with DH/DE Lymphoma.
DLBCL with alterations in both the MYC gene and the BCL2 gene is defined as Double-Hit Lymphoma. In preclinical studies, the combination of fimepinostat with venetoclax has demonstrated highly synergistic effect, resulting in significant tumor size reduction.
Precision oncology, CA-4948 (IRAK4 Kinase Inhibitor; Aurigene collaboration):

Curis continues to enroll patients with relapsed or refractory non-Hodgkin lymphoma in a dose escalation study evaluating CA-4948, a first-in-class oral, small molecule IRAK4 kinase inhibitor. CA-4948 is designed to target cancers with MYD88 mutations in DLBCL and Waldenström’s macroglobulinemia.
Immuno-oncology, CA-170 (VISTA / PDL1 antagonist; Aurigene collaboration):

Patient treatment continues in the dose escalation study evaluating CA-170 in patients with advanced solid tumors or lymphomas.
Curis is working with select clinical sites to initiate a study of CA-170 in patients with mesothelioma, following evidence of mesothelioma tumor samples expressing high levels of VISTA. Recent publications have identified VISTA as a possible resistance mechanism to treatment with anti-PD1 antibodies in several cancer indications.
Curis collaborator Aurigene continues to enroll immunotherapy treatment-naïve patients in a clinical study of CA-170 at select trial sites in India.
Recent Corporate Highlights

In September, Curis announced change in leadership with the appointment of James Dentzer to the position of President and Chief Executive Officer.
In October, Curis implemented a 27% reduction in headcount and a re-allocation of pre-clinical resources to strengthen focus on clinical development. The Company expects the net result of expense reductions in pre-clinical R&D and G&A and targeted increases in clinical operations to result in a total cash burn reduction from approximately $11 million to $8 million per quarter going forward.
Upcoming Activities

Curis will provide an update on the dose escalation study of CA-170 at the annual SITC (Free SITC Whitepaper) conference in November.
2019 Data Catalysts

Curis expects to commence enrollment in a combination study evaluating a fimepinostat and venetoclax regimen in patients with R/R DLBCL, including patients with DH/DE Lymphoma, in the first half of 2019 and report initial data in the second half of 2019.
Curis expects to report initial data from an ongoing dose escalation study evaluating CA-4948 in patients with R/R DLBCL and WM, including patients with MYD88-altered disease, by mid-year 2019.
Curis expects to commence enrollment in a clinical study evaluating CA-170 in patients with mesothelioma (high VISTA expressors) in the first half of 2019 and report initial data in the second half of 2019.
Conference Call Information

Curis management will host a conference call today, November 1, 2018, at 8:30 a.m. ET, to discuss these financial results, as well as provide a corporate update.

To access the live conference call, please dial 1-888-346-6389 (United States) or 1-412-317-5252 (International), shortly before 8:30 a.m. ET. The conference call can also be accessed on the Curis website at www.curis.com in the Investors section. A replay of the call will be available on the Curis website shortly after the commencement of the meeting

On November 1, 2018 Intrexon Corporation (NASDAQ: XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet, reported it will release third quarter 2018 financial results after the market closes on Thursday, November 8th, 2018 (Press release, Intrexon, NOV 1, 2018, View Source [SID1234530547]). The Company will host a conference call that day at 5:30 PM ET to discuss the results and provide a general business update.

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The conference call may be accessed by dialing 1-888-317-6003 (Domestic US), 1-866-284-3684 (Canada), and 1-412-317-6061 (International) and providing the number 8225818 to join the Intrexon Corporation Call. Participants may also access the live webcast through Intrexon’s website in the Investors section at View Source

On November 1, 2018 Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) reported consolidated financial results for the third quarter ended September 30, 2018 (Press release, Pacira Pharmaceuticals, NOV 1, 2018, View Source;p=irol-newsArticle&ID=2374725 [SID1234530546]).

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"As evident from these financial results, EXPAREL continues to deliver impressive sales growth with physicians having great success delivering targeted, long-acting, opioid-free local or regional analgesia for postsurgical pain in a variety of procedures," said Dave Stack, chairman and chief executive officer of Pacira Pharmaceuticals. "Specifically we are seeing great enthusiasm around the use of EXPAREL as a brachial plexus nerve block and an increasing number of anesthesiologists incorporating EXPAREL into their suite of postsurgical pain solutions by expanding its use in newer regional anesthesia techniques, such as transverse abdominis, pectoralis and fascial iliaca plane blocks. In addition, our highly successful partnership with Johnson & Johnson remains a key growth driver as we integrate EXPAREL into multiple joint marketing programs, including a new initiative that will feature EXPAREL and TYLENOL as a platform for opioid-free postsurgical pain relief. Overall we are very pleased to be increasing our financial guidance for the second time this year."

"Looking forward we expect various initiatives to expand access to EXPAREL, particularly the assignment of new ambulatory care and dental reimbursement codes at the beginning of 2019, as well as increasing public and private payer recognition of the need for non-opioid pain relief following surgery."

Third Quarter 2018 Financial Results

EXPAREL net product sales were $82.2 million in the third quarter of 2018, a 23% increase over the $66.8 million reported for the third quarter of 2017.

Total operating expenses were $79.4 million in the third quarter of 2018, compared to $70.9 million in the third quarter of 2017.

GAAP net loss was $0.6 million, or $(0.02) per share (basic and diluted), in the third quarter of 2018, compared to a GAAP net loss of $7.6 million, or $(0.19) per share (basic and diluted), in the third quarter of 2017.

Non-GAAP net income was $12.8 million, or $0.31 per share (basic and diluted) in the third quarter of 2018, compared to non-GAAP net income of $4.4 million, or $0.11 per share (basic and diluted) in the third quarter of 2017.

Pacira ended the third quarter of 2018 with cash, cash equivalents and short-term investments ("cash") of $386.4 million.

Pacira had 41.0 million basic weighted average shares of common stock outstanding in the third quarter of 2018.

Pacira had 42.0 million diluted weighted average shares of common stock outstanding in the third quarter of 2018.
2018 Financial Guidance

Today, the company is increasing its full-year 2018 guidance for EXPAREL net product sales and improving its guidance for non-GAAP gross margins. The remainder of the company’s guidance remains unchanged from the ranges previously provided in August 2018. A summary of Pacira’s full-year 2018 financial guidance is outlined below.

EXPAREL net product sales of $325 million to $330 million.

Non-GAAP gross margins of 74% to 75%.

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

Non-GAAP selling, general and administrative (SG&A) expense of $150 million to $160 million.

Stock-based compensation of $30 million to $35 million.
See "Non-GAAP Financial Information" and "Reconciliations of GAAP to Non-GAAP 2018 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, Thursday, November 1, at 8:30 a.m. ET. To participate in the conference call, dial 1-877-845-0779 and provide the passcode 1988603. International callers may dial 1-720-545-0035 and use the same passcode. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com.

For those unable to participate in the live call, a replay will be available at 1-855-859-2056 (domestic) or 1-404-537-3406 (international) using the passcode 1988603. The replay of the call will be available for one week from the date of the live call. The webcast will be available on the Pacira website for approximately 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 net income (loss) per share, non-GAAP cost of goods sold, non-GAAP gross margins, non-GAAP research and development (R&D) expense and non-GAAP selling, general and administrative (SG&A) expense, because such measures exclude milestone revenue, stock-based compensation, amortization of debt discount, loss on early extinguishment of debt, exit costs related to the discontinuation of DepoCyt(e) production and loss on an unexercised investment purchase option.

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 expense and SG&A expense outlook for 2018 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 2018 financial guidance for gross margins, R&D expense and SG&A expense.