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Verastem Oncology Reports on Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Follicular Lymphoma Opportunity, Landscape and Advancements in Pre-Commercial Initiatives at Analyst and Investor Day

On May 3, 2018 Verastem, Inc. (NASDAQ:VSTM) (Verastem Oncology or the Company), focused on developing and commercializing drugs to improve the survival and quality of life of cancer patients, yesterday hosted in New York City an Analyst and Investor Day, titled, "Duvelisib: Harnessing the Power of Dual PI3K Inhibition (Press release, Verastem, MAY 3, 2018, View Source;p=RssLanding&cat=news&id=2346689 [SID1234526027])."

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The program featured key opinion leaders in the hematologic oncology field: Jennifer Brown, MD, PhD, Associate Professor of Medicine, Harvard Medical School Director, and Director, CLL Center of the Division of Hematologic Malignancies, Dana-Farber Cancer Institute; Ian Flinn, MD, PhD, Director, Blood Cancer Research Program at Sarah Cannon Research Institute, and Lead Investigator of the DUO and DYNAMO Studies; Steven Horwitz, MD, Medical Oncologist, Memorial Sloan Kettering Cancer Center and NYC Health + Hospitals/Bellevue; Brian Koffman, MDCM, DCFP, FCFP, DABFP, MSEd, Physician, Medical Director of the Chronic Lymphocytic Leukemia (CLL) Society and CLL Patient; and Lori Kunkel, MD, Former Chief Medical Officer, Pharmacyclics.

These leading experts in hematologic malignancies, including chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), follicular lymphoma (FL), and peripheral T-cell lymphoma (PTCL), provided an in-depth discussion regarding the current U.S. treatment landscape, where phosphoinositide-3-kinase (PI3K)- inhibitors fit into the treatment paradigm and the need for new anti-cancer agents such as duvelisib, the Company’s first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma. Joe Lobacki, Chief Commercial Officer of Verastem, outlined the Company’s commercialization strategy and plans, including an overview of ongoing pre-commercial and launch initiatives, in preparation for the potential launch of duvelisib in the U.S. following the assigned target action date of October 5, 2018. Following the presentations, Robert Forrester, President and Chief Executive Officer of Verastem, moderated an expert panel discussion which highlighted the unmet need in CLL/SLL, FL and T-cell lymphomas, the clinical utility of PI3K-inhibitors and in particular duvelisib, as well as current treatment practices and their perspectives on the medical need for new treatment options.

"At Verastem Oncology, we care differently. We are driven by the strength, tenacity and courage of those battling cancer and are single-minded in our resolve to deliver new therapies to patients in need," said Robert Forrester, President and Chief Executive Officer of Verastem. "I want to extend my thanks to the outstanding panel of experts for their presentations and thoughtful discussion. Their comments further reinforce our belief in the unmet need of CLL/SLL and FL patients, the importance of PI3K inhibitors, as well as the gap that duvelisib will fill, if approved."

Presentation Highlights

Brian Koffman, MDCM, DCFP, FCFP, DABFP, MSEd, Physician, Founder & President of the CLL Society, and CLL patient kicked off the morning by taking the audience through the CLL patient journey, along with the learnings and challenges of living with high risk disease. Dr. Koffman, who was diagnosed twelve years ago with CLL, highlighted his perspective on what patients want, "I believe that more targeted options are needed for relapsed patients and therapy should be matched to each individual’s profile and preference."

Lori Kunkel, MD, former CMO at Pharmacyclics with global approval of cancer therapeutic IMBRUVICA, presented the evolving landscape of therapies for hematologic malignancies. As Dr. Kunkel noted, there are a number of factors to consider when treating patients with CLL/SLL or FL, including resistance or intolerance to first-line therapies, patient sub-types, and comorbidities. She went on to illustrate that every patient is different, concluding that there is no single solution for all patients and more options, like duvelisib, are needed for these incurable diseases.

Jennifer Brown, MD, PhD, Director of the CLL Center of the Division of Hematologic Malignancies, Dana-Farber Cancer Institute, and Associate Professor of Medicine at Harvard Medical School, gave a compelling presentation on the role of PI3K inhibitors as treatment evolves towards a chemo-free future for many patients with B-Cell malignancies. "While there are other, efficacious targeted therapies available, each comes with its own limitations," noted Dr. Brown. Her presentation focused on the role of the PI3K inhibitor, the large and growing population of patients intolerant of BTK inhibitors, particularly older patients, and a steadily increasing population progressing on BTK and BCL-2 inhibitors. "While venetoclax is an effective therapy, it can be very challenging to give in a community setting. Duvelisib has a novel mechanism that is easily given with no infusions required. This may provide a benefit to older patients in the community, which represents the majority of the patients," she concluded.

Ian Flinn, MD, PhD, Director, Blood Cancer Research Program at Sarah Cannon Research Institute was the lead Investigator of the DUO and DYNAMO studies, the basis for the New Drug Application for duvelisib. "In the Phase 3 DUO study, oral duvelisib monotherapy achieved a statistically significant improvement in progression-free survival (PFS) versus the approved standard of care treatment ofatumumab, along with a well characterized and manageable safety profile, in patients with previously treated CLL/SLL," noted Dr. Flinn. During an overview of the Phase 2 DYNAMO data, Dr. Flinn commented, "The clinical activity and durability of responses observed in the DYNAMO study, seen across highly refractory disease subtypes such as FL, highlight the potential of this drug in lymphoid malignancies. These results were seen in patients who were refractory to both rituximab and chemotherapy, a specific population with unmet medical need." Dr. Flinn concluded by saying, "Additional options are needed for a physician’s armamentarium in the treatment of chronic indolent lymphomas and leukemias and the sequential use of clinically manageable treatments may extend the period of disease control. Continued development of oral, targeted therapies such as duvelisib, is necessary to address the medical unmet need. The DYNAMO and DUO results support duvelisib oral monotherapy as a potential new and convenient treatment option for previously treated CLL/SLL or FL patients."

Dr. Steve Horwitz, Medical Oncologist at Memorial Sloan Kettering, presented an overview of the unmet need for new strategies in T-cell lymphoma. He presented encouraging Phase 1 clinical data where duvelisib demonstrated a 50% investigator-assessed overall response rate in 16 heavily pre-treated patients with relapsed or refractory PTCL, including a 19% complete response rate and a 31% partial response rate. Dr. Horwitz also presented data showing that oral duvelisib, in combination with either romidepsin or bortezomib, has an acceptable safety profile in patients with relapsed or refractory TCL with meaningful response rates, noting, "While still preliminary, the results appear promising when compared to those seen with currently approved therapies. We were especially pleased to see that these response rates were even higher in patients with PTCL, a rare and aggressive type of non-Hodgkin lymphoma." Dr. Horwitz is an investigator on PRIMO, an open-label, multicenter, Phase 2 clinical trial evaluating the efficacy and safety of duvelisib in patients with relapsed or refractory PTCL that is currently being initiated in the US, EU and Japan.

Mr. Lobacki, former Chief Commercial Officer at Medivation, concluded the presentations by highlighting the current limited options for CLL/SLL and FL patients and where duvelisib meets the unmet needs of both patients and physicians. He provided an overview of how duvelisib could potentially fit into the treatment landscape, given its profile as a first in class dual PI3K inhibitor with demonstrated clinical efficacy in relapsed lymphomas, a single CLL/SLL and FL therapy option with a safety profile that is well characterized and manageable, a chemo-free option that has shown signs of clinical efficacy regardless of tumor burden or genetic alterations, and a daily oral monotherapy that can be taken at home with no planned hospitalization or infusions required. Mr. Lobacki also outlined Verastem’s plan to commercialize duvelisib in the U.S. including sales force size, geographic coverage, reimbursement and access as well as plans to prioritize a seamless patient experience. "With this go-to-market plan and this commercial launch, we anchor duvelisib in relapsed CLL and FL. However, this is just the start, as we have a strong foundation for future growth into other important markets," he concluded.

At the Analyst and Investor Day event, the Company also announced that it will change its name to Verastem Oncology. Shares of the Company’s common stock will continue to trade on the Nasdaq Global Market under the symbol "VSTM." The name change reinforces Verastem’s commitment to advance innovative treatment options to improve the lives of patients battling cancer.

An archived webcast of the event is available on the "Events and Presentations" page in the "Investors" section of the Company’s website at www.verastem.com.

About Duvelisib

Duvelisib is a first-in-class investigational oral, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells and T-cells. PI3K signaling may lead to the proliferation of malignant B- and T-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 Duvelisib was evaluated in late- and mid-stage extension trials, including DUO, a randomized, Phase 3 monotherapy study in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL),4 and DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL).5 Both DUO and DYNAMO achieved their primary endpoints. Verastem Oncology’s New Drug Application (NDA) requesting the full approval of duvelisib for the treatment of patients with relapsed or refractory CLL/SLL, and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma (FL) was accepted for filing by the U.S. Food and Drug Administration (FDA), granted Priority Review and assigned a target action date of October 5, 2018. Duvelisib is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), and is being investigated in combination with other agents through investigator-sponsored studies.6 Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

Valeant To Participate At Goldman Sachs Third Annual Leveraged Finance Conference

On May 3, 2018 Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) ("Valeant") reported that Paul S. Herendeen, executive vice president, Finance, and chief financial officer, is scheduled to participate at the Goldman Sachs Third Annual Leveraged Finance Conference in Rancho Palos Verdes, Calif. on Thursday, May 10, 2018 at 2:10 p.m. PDT (5:10 p.m. EDT) (Press release, Valeant, MAY 3, 2018, http://ir.valeant.com/news-releases/2018/05-03-2018-130141166 [SID1234526026]).

A live webcast and audio archive of the event will be available on the Investor Relations page of the Valeant web site at: http://ir.valeant.com/events-and-presentations/2018.

Regeneron Reports First Quarter 2018 Financial and Operating Results

On May 3, 2018 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported financial results for the first quarter of 2018 and provided a business update (Press release, Regeneron, MAY 3, 2018, View Source [SID1234526025]).

"Regeneron’s commercial business continues to advance with positive sales growth for EYLEA and strong underlying demand for Dupixent," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "This year, we have reported positive Phase 3 results for Praluent in cardiovascular risk reduction and for EYLEA in diabetic retinopathy – and look forward to continued progress with Dupixent, including a U.S. regulatory decision in uncontrolled asthma and Phase 3 results in both adolescents with atopic dermatitis and adults with nasal polyps. Our immuno-oncology portfolio is advancing rapidly, with a potential first approval for cemiplimab in advanced cutaneous squamous cell carcinoma, and a broad pivotal program in lung cancer."

First Quarter 2018 Business Highlights

Key Pipeline Progress
Regeneron has seventeen product candidates in clinical development, which consist of EYLEA and fully human antibodies generated using the Company’s VelocImmune technology, including six in collaboration with Sanofi. Updates from the clinical pipeline include:
EYLEA (aflibercept) Injection

In the first quarter of 2018, the Company announced positive top-line results from the Phase 3 PANORAMA study of EYLEA in moderately severe to severe non-proliferative diabetic retinopathy (NPDR). PANORAMA will form the basis of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) by the end of the year.

Dupixent (dupilumab) Injection

Dupixent, an antibody that blocks signaling of IL-4 and IL-13, is currently approved in atopic dermatitis for adults in the United States, European Union, and certain other countries outside the United States.

Dupilumab is being studied in asthma, adolescent and pediatric atopic dermatitis, nasal polyps, and eosinophilic esophagitis (EoE), with additional studies planned in 2018. Data are expected to be reported from Phase 3 studies in patients with nasal polyps and adolescent patients with atopic dermatitis during 2018.

In March 2018, the sBLA for Dupixent as an add-on maintenance treatment in certain adults and adolescents (12 years of age and older) with moderate-to-severe asthma was filed with the FDA, with a target action date of October 20, 2018. In the first quarter of 2018, regulatory applications were also accepted for review by the European Medicines Agency (EMA) and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan for Dupixent in asthma.

Dupixent for the treatment of atopic dermatitis in adults not adequately controlled with existing therapies was approved by the Ministry of Health, Labor and Welfare (MHLW) in Japan in the first quarter of 2018, and has recently been launched.

In the first quarter of 2018, a Phase 2/3 study in younger pediatric patients (from six months to five years of age) with severe atopic dermatitis was initiated.

Praluent (alirocumab) Injection

In the first quarter of 2018, the Company and Sanofi announced that the ODYSSEY OUTCOMES trial met its primary endpoint, demonstrating that high-risk patients who added Praluent to maximally-tolerated statins experienced significantly fewer major adverse cardiovascular events compared to those on maximally-tolerated statins alone. In addition, in this study, adding Praluent to maximally-tolerated statins was associated with reduced death from any cause.

In May 2018, the Company and Sanofi announced they will lower the net price of Praluent in exchange for straightforward, more affordable patient access from Express Scripts. Praluent will become the exclusive PCSK9 inhibitor therapy on the Express Scripts national formulary. The agreement takes effect on July 1, 2018 for commercial patients covered by the Express Scripts National Preferred Formulary (approximately 25 million individuals in total).

Cemiplimab, an antibody to programmed cell death protein 1 (PD-1), is being studied in patients with cancer.

In April 2018, the FDA accepted for priority review the BLA for cemiplimab for the treatment of patients with metastatic CSCC or patients with locally advanced CSCC who are not candidates for surgery. The target action date for the FDA decision is October 28, 2018.

In April 2018, the EMA also accepted for review the Marketing Authorization Application (MAA) for cemiplimab in patients with metastatic CSCC or patients with locally advanced CSCC who are not candidates for surgery.

Fasinumab, an antibody targeting Nerve Growth Factor (NGF), is being studied in patients with osteoarthritis of the knee or hip and chronic low back pain in patients with concomitant osteoarthritis of the knee or hip.

An independent Data Monitoring Committee monitoring the ongoing safety and efficacy of the fasinumab clinical trials recommended that the higher dose-regimens be discontinued based on the risk benefit assessment and that the program may continue with the lower dose-regimens of fasinumab. The trials are being modified accordingly.

Evinacumab is an antibody to angiopoietin-like protein 3 (ANGPTL3). A Phase 3 study in homozygous familial hypercholesterolemia (HoFH) was initiated in the first quarter of 2018.

Financial Results

Product Revenues: Net product sales were $988 million in the first quarter of 2018, compared to $858 million in the first quarter of 2017. EYLEA net product sales in the United States were $984 million in the first quarter of 2018, compared to $854 million in the first quarter of 2017. Overall distributor inventory levels remained within the Company’s one- to two-week targeted range.

Total Revenues: Total revenues, which include product revenues described above, increased by 15% to $1.511 billion in the first quarter of 2018, compared to $1.319 billion in the first quarter of 2017. Total revenues include Sanofi and Bayer collaboration revenues of $437 million in the first quarter of 2018, compared to $404 million in the first quarter of 2017. Sanofi collaboration revenue in the first quarter of 2018 decreased primarily due to the Company’s Discovery and Preclinical Development Agreement with Sanofi ending on December 31, 2017, lower reimbursement for Dupixent (dupilumab) development activities, and an increase in the Company’s share of the collaborations’ Dupixent commercialization expenses. These decreases were partly offset by the Company’s share of higher net sales of Dupixent (as the product was launched at the end of March 2017), and an increase in reimbursement revenues in connection with late-stage clinical development activities for cemiplimab. Bayer collaboration revenue increased in the first quarter of 2018 primarily due to an increase in the Company’s share of net profits in connection with higher sales of EYLEA outside the United States.

Other revenue in the first quarter of 2018 increased primarily due to higher reimbursements of the Company’s fasinumab research and development expenses in connection with the Company’s collaboration agreement with Teva.

The Company adopted Accounting Standard Codification (ASC) 606, Revenue from Contracts with Customers, as of January 1, 2018. The Company adopted the standard using the modified retrospective method; prior period amounts have not been adjusted and the Company recognized a cumulative-effect adjustment to reduce Retained earnings and increase Deferred revenue on January 1, 2018 by $143 million, net of tax. The adoption of the new standard did not have a material impact of the Company’s total revenues in the first quarter of 2018.

Refer to Table 4 for a summary of collaboration and other revenue.

Research and Development (R&D) Expenses: GAAP R&D expenses were $499 million in the first quarter of 2018, compared to $507 million in the first quarter of 2017. The lower R&D expenses in the first quarter of 2018 were principally due to a decrease in clinical manufacturing costs and a decrease in dupilumab development costs. These decreases were partly offset by an increase in cemiplimab and fasinumab clinical trial costs. In the first quarter of 2018, R&D-related non-cash share-based compensation expense was $41 million, compared to $74 million in the first quarter of 2017. The decrease in total non-cash share-based compensation expense in the first quarter of 2018 was primarily attributable to a revision in the Company’s estimate of the number of stock options that are expected to be forfeited.

Selling, General, and Administrative (SG&A) Expenses: GAAP SG&A expenses were $331 million in the first quarter of 2018, compared to $297 million in the first quarter of 2017. The higher SG&A expenses in the first quarter of 2018 were primarily due to higher headcount and headcount-related costs and an increase in commercialization-related expenses to support the launch of Dupixent. In the first quarter of 2018, SG&A-related non-cash share-based compensation expense decreased to $35 million, compared to $54 million in the first quarter of 2017, primarily due to the revision in the Company’s estimate of stock option forfeitures as described under "R&D Expenses" above.

Income Tax Expense: In the first quarter of 2018, GAAP income tax expense was $107 million and the effective tax rate was 18.3%, compared to $183 million and 42.4% in the first quarter of 2017. The Company’s effective tax rate for the first quarter of 2018 was significantly impacted by the bill known as the Tax Cuts and Jobs Act (the "U.S. Tax Reform Act"), which reduced the U.S. federal corporate income tax rate from 35% to 21% effective January 1, 2018. The effective tax rate for the first quarter of 2018 was positively impacted, compared to the U.S. federal statutory rate, primarily by the foreign-derived intangible income deduction and the federal tax credit for research activities.

Other income, net: GAAP other income in the first quarter of 2018 included the recognition of unrealized gains on equity securities. In the first quarter of 2018, the Company adopted Accounting Standards Update ("ASU") 2016-01, Recognition and Measurement of Financial Assets and Financial Liabilities, as of January 1, 2018, which requires the Company to measure equity investments at fair value with changes in fair value recognized in net income; previously, such changes in fair value were recognized in Other comprehensive income (loss). Refer to Table 3 for the non-GAAP adjustment related to these gains.

GAAP and Non-GAAP Net Income(2): GAAP net income was $478 million, or $4.44 per basic share and $4.16 per diluted share, in the first quarter of 2018, compared to GAAP net income of $249 million, or $2.36 per basic share and $2.16 per diluted share, in the first quarter of 2017.

Non-GAAP net income was $537 million, or $4.99 per basic share and $4.67 per diluted share, in the first quarter of 2018, compared to non-GAAP net income of $337 million, or $3.19 per basic share and $2.92 per diluted share, in the first quarter of 2017

Regeneron records net product sales of EYLEA in the United States. Outside the United States, EYLEA net product sales comprise sales by Bayer in countries other than Japan and sales by Santen Pharmaceutical Co., Ltd. in Japan under a co-promotion agreement with an affiliate of Bayer. The Company recognizes its share of the profits (including a percentage on sales in Japan) from EYLEA sales outside the United States within "Bayer collaboration revenue" in its Statements of Operations.

This press release uses non-GAAP net income, non-GAAP net income per share, non-GAAP unreimbursed R&D, and non-GAAP SG&A, which are financial measures that are not calculated in accordance with U.S. Generally Accepted Accounting Principles ("GAAP"). These non-GAAP financial measures are computed by excluding certain non-cash and other items from the related GAAP financial measure. Non-GAAP adjustments also include the estimated income tax effect of reconciling items.

The Company makes such adjustments for items the Company does not view as useful in evaluating its operating performance. For example, adjustments may be made for items that fluctuate from period to period based on factors that are not within the Company’s control (such as the Company’s stock price on the dates share-based grants are issued or changes in the fair value of the Company’s equity investments) or items that are not associated with normal, recurring operations (such as changes in applicable laws and regulations). Management uses these non-GAAP measures for planning, budgeting, forecasting, assessing historical performance, and making financial and operational decisions, and also provides forecasts to investors on this basis. Additionally, such non-GAAP measures provide investors with an enhanced understanding of the financial performance of the Company’s core business operations. However, there are limitations in the use of these and other non-GAAP financial measures as they exclude certain expenses that are recurring in nature. Furthermore, the Company’s non-GAAP financial measures may not be comparable with non-GAAP information provided by other companies. Any non-GAAP financial measure presented by Regeneron should be considered supplemental to, and not a substitute for, measures of financial performance prepared in accordance with GAAP. A reconciliation of the Company’s historical GAAP to non-GAAP results is included in Table 3 of this press release.

The Company’s 2018 financial guidance does not assume the completion of any significant business development transactions not completed as of the date of this press release.

Conference Call Information

Regeneron will host a conference call and simultaneous webcast to discuss its first quarter 2018 financial and operating results on Thursday, May 3, 2018, at 8:30 AM. To access this call, dial (800) 708-4540 (U.S.) or (847) 619-6397 (International). A link to the webcast may be accessed from the "Investors & Media" page of Regeneron’s website at View Source A replay of the conference call and webcast will be archived on the Company’s website and will be available for 30 days.

Pacira Pharmaceuticals, Inc. Reports First Quarter 2018 Financial Results

On May 3, 2018 Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) reported consolidated financial results for the first quarter ended March 31, 2018 (Press release, Pacira Pharmaceuticals, MAY 3, 2018, View Source;p=RssLanding&cat=news&id=2346741 [SID1234526024]).

"2018 is off to a terrific start with EXPAREL daily sales volumes accelerating from 6 percent in January to 15 percent in March, as well as a recently expanded label that now includes interscalene brachial plexus block," said Dave Stack, chairman and chief executive officer of Pacira Pharmaceuticals. "As the only long-acting, single-dose nerve block commercially available, EXPAREL has the potential to eliminate cumbersome delivery technologies, like catheters and pumps, and shift more procedures to the outpatient setting. We believe this expanded label along with our robust educational initiatives and strong coalition of like-minded collaborators, including Johnson & Johnson, will fuel positive sales trends as we continue to drive meaningful change toward eliminating the role of the operating room as a gateway to opioid use and abuse."

First Quarter 2018 Financial Results

EXPAREL net product sales were $74.0 million in the first quarter of 2018, a 9% increase over the $67.7 million reported for the first quarter of 2017.

Total operating expenses were $81.5 million in the first quarter of 2018, compared to $83.3 million in the first quarter of 2017.

GAAP net loss was $10.7 million, or $(0.26) per share (basic and diluted), in the first quarter of 2018, compared to a GAAP net loss of $19.9 million, or $(0.52) per share (basic and diluted), in the first quarter of 2017.

Non-GAAP net income was $0.9 million, or $0.02 per share (basic and diluted) in the first quarter of 2018, compared to a non-GAAP net loss of $7.3 million, or $(0.19) per share (basic and diluted) in the first quarter of 2017.

Pacira ended the first quarter of 2018 with cash, cash equivalents, short-term and long-term investments ("cash") of $361.5 million.

Pacira had 40.7 million basic weighted average shares of common stock outstanding in the first quarter of 2018.

For non-GAAP measures, Pacira had 41.6 million diluted weighted average shares of common stock outstanding in the first quarter of 2018.
2018 Outlook

Pacira reiterated its full year 2018 financial guidance as follows. Pacira expects:

EXPAREL net product sales of $300 million to $310 million.

Non-GAAP gross margins of 70% to 72%.

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, May 3, 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 6585169.

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 6585169. 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, 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 stock-based compensation, amortization of debt discount, loss on early extinguishment of debt and exit costs related to the discontinuation of DepoCyt(e) production.

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.

OncoSec to Present at Eighth Annual BioNJ BioPartnering Conference

On May 3, 2018 OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, reported that Daniel J. O’Connor, Chief Executive Officer of OncoSec, will present at the Eighth Annual BioNJ BioPartnering Conference, developed in partnership with J.P. Morgan, being held Thursday, May 3, 2018 at the The Palace at Somerset Park in Somerset, NJ (Press release, OncoSec Medical, MAY 3, 2018, View Source [SID1234526023]).

As part of his presentation, Mr. O’Connor will discuss OncoSec’s corporate growth strategy; provide a comprehensive overview of the Company’s ongoing and anticipated clinical programs involving ImmunoPulse IL-12 (or Intratumoral tavo-EP) in metastatic melanoma and triple-negative breast cancer (TNBC); and the potential of ImmunoPulse IL-12 as a monotherapy and in combination with anti-PD-1 antibody therapy in metastatic melanoma and triple-negative breast cancer (TNBC). In addition to the presentation, management will participate in one-on-one meetings with qualified members of the investor community who are registered to attend the conference.

BioNJ’s Eighth Annual BioPartnering Conference, developed in partnership with J.P. Morgan Chase, will bring together nearly 400 public and private company investors, life sciences professionals and academic partners from the Northeast to Mid-Atlantic states. Pharmaceutical sponsors for the conference include The Janssen Pharmaceutical Companies of Johnson & Johnson, Merck, and Pfizer.