On August 2, 2018 Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) reported consolidated financial results for the second quarter ended June 30, 2018 (Press release, Pacira Pharmaceuticals, AUG 2, 2018, View Source;p=irol-newsArticle&ID=2361688 [SID1234528322]).

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"The first half of 2018 was marked by tremendous progress as our EXPAREL growth strategy is taking hold and driving robust topline results," said Dave Stack, chairman and chief executive officer of Pacira. "These positive results reflect the growing role of EXPAREL as an integral component of multimodal pain management due to its tremendous flexibility around dosing, volume expansion, and admixing. EXPAREL allows physicians to deliver long-acting, opioid-free local or regional analgesia using individualized approaches for both small and large procedures. We are seeing a high level of engagement and enthusiasm around our expanded label that now includes brachial plexus nerve block and an uptick in the successful use of EXPAREL as a field block for soft tissue procedures. Our partnered Johnson and Johnson accounts are delivering impressive results in the orthopedic space with significant room for expansion in key procedures, such as spine, shoulder and hip fractures. Across all aspects of the business, we are very pleased with the market dynamics and our ability to increase our full-year sales guidance for EXPAREL."

Highlights and Recent Events

Licensing agreement with Nuance Biotech for EXPAREL in China. Pacira and Nuance Biotech Co. Ltd, a China-based specialty pharmaceutical company, entered into an agreement to advance the development and commercialization of EXPAREL in China.
Collaboration with Aetna now highlighting providers offering opioid alternatives, including EXPAREL. Aetna began updating its online provider directory, DocFind, to help members easily identify surgeons who are committed to offering opioid alternatives, including EXPAREL.
MEDNAX National Medical Group and Pacira launched national initiative to minimize opioid use after cesarean surgery. Pacira and MEDNAX launched a partnership to address the ongoing use of opioids during and after cesarean surgery by launching a national collaborative aimed at implementing an Enhanced Recovery after Cesarean Surgery (ERACS) program.
Second Quarter 2018 Financial Results

EXPAREL net product sales were $80.4 million in the second quarter of 2018, a 15% increase over the $69.8 million reported for the second quarter of 2017.

Total operating expenses were $77.6 million in the second quarter of 2018, compared to $86.7 million in the second quarter of 2017.

GAAP net income was $2.6 million, or $0.06 per share (basic and diluted), in the second quarter of 2018, compared to a GAAP net loss of $19.7 million, or $(0.49) per share (basic and diluted), in the second quarter of 2017.

Non-GAAP net income was $9.9 million, or $0.24 per share (basic and diluted) in the second quarter of 2018, compared to a non-GAAP net loss of $4.4 million, or $(0.11) per share (basic and diluted) in the second quarter of 2017.

Pacira ended the second quarter of 2018 with cash, cash equivalents, short-term and long-term investments ("cash") of $372.9 million.

Pacira had 40.8 million basic weighted average shares of common stock outstanding in the second quarter of 2018.

Pacira had 41.7 million diluted weighted average shares of common stock outstanding in the second quarter of 2018.
2018 Outlook

Pacira increased its full year 2018 financial guidance for EXPAREL net product sales and updated its remaining full-year 2018 financial guidance as follows:

EXPAREL net product sales of $320 million to $325 million.

Non-GAAP gross margins of 72% to 74%.

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, August 2, at 8:30 a.m. ET. To participate in the conference call, dial 1-877-845-0779 and provide the passcode 5387259. 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 5387259. 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 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.

On August 2, 2018 Savara Inc. (NASDAQ: SVRA), an orphan lung disease company, reported it will release its second quarter 2018 financial results on Thursday, August 9, 2018 (Press release, Savara, AUG 2, 2018, View Source [SID1234528323]). Savara management will also host a conference call for investors beginning at 5:30 p.m. ET on Thursday August 9, 2018 to discuss its second quarter 2018 financial results and to provide a business update.

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Shareholders and other interested parties may access the conference call by dialing (855) 239-3120 from the U.S., (855) 669-9657 from Canada, and (412) 542-4127 from elsewhere outside the U.S. and request the Savara Inc. call. A live webcast of the conference call will be available online in the Investors section of Savara’s website at View Source Replays of the webcast will be available on Savara’s website for 30 days and a telephone replay will be available through August 16, 2018 by dialing (877) 344-7529 from the U.S., (855) 669-9658 from Canada, and (412) 317-0088 from elsewhere outside the U.S. and entering replay access code 10122221.

On August 2, 2018 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that management will present at the upcoming Canaccord Genuity 38th Annual Growth Conference taking place August 8-9, 2018 in Boston, MA, USA (Press release, Zymeworks, AUG 2, 2018, View Source [SID1234528351]).

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The Company will provide a corporate update and present upcoming catalysts on Wednesday, August 8, 2018 at 2:00 p.m. ET. Interested parties can access a live webcast of the presentation via a link from Zymeworks’ website at View Source, which will also host a recorded replay available afterwards.

On August 2, 2018 Epizyme, Inc. (NASDAQ: EPZM), a clinical-stage company developing novel epigenetic therapies, reported financial results for the second quarter of 2018 and provided key business updates (Press release, Epizyme, AUG 2, 2018, View Source [SID1234528418]).

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"In the second quarter, we presented encouraging new clinical data regarding tazemetostat’s anti-tumor activity and tolerability in follicular lymphoma and mesothelioma," said Robert Bazemore, president and chief executive officer of Epizyme. "As we enter the second half of 2018, we have focused the organization on several strategic priorities. First and foremost, we are working diligently to resolve the partial clinical hold and resume enrollment in tazemetostat clinical studies. In addition, we are progressing tazemetostat toward a first NDA for the treatment of epithelioid sarcoma, continuing to advance its development in follicular lymphoma based on the strength of our clinical data, and advancing our novel inhibitor of G9a, EZM8266, toward the clinic. We believe the actions we have taken will allow us to capitalize on our near-term tazemetostat opportunities while also extending our cash runway."

Partial Clinical Hold Update

A partial clinical hold pausing the enrollment of new patients into tazemetostat clinical trials was implemented in the second quarter of 2018 in the United States, France and Germany following a safety report of a single pediatric patient who developed a secondary T-cell lymphoblastic lymphoma (T-LBL). Epizyme has reconsented all patients in its clinical trials and updated its informed consent form based on this safety report. The company also reviewed the single T-LBL case in detail, recently completed a comprehensive assessment of tazemetostat safety data and clinical activity observed to date across clinical trials, and convened a panel of external experts to review and validate the assessment. This information will be included in a formal response to regulatory authorities.

Epizyme plans to continue its engagement with the U.S. Food and Drug Administration (FDA) in the weeks ahead and then finalize its response to regulatory authorities, including changes that may be proposed to study protocols. Once the company has gained alignment with regulators in the U.S., France and Germany, it is anticipated that the partial clinical hold would be lifted and that enrollment activities would be allowed to proceed in those countries.

ES Program Update

At the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in October 2018, Epizyme plans to present updated Phase 2 data from patients with epithelioid sarcoma (ES) who are receiving tazemetostat as a monotherapy. Enrollment in this trial was completed in July 2017. A recent assessment of interim data from the full 62-patient ES cohort in this study has shown that the objective response rate has remained consistent with what was observed in the initial 31 enrolled patients. In addition, durability data from the cohort continue to mature.

Epizyme is continuing to prepare its first New Drug Application (NDA) submission for tazemetostat for the treatment of patients with ES. In order to include more mature durability data

in its submission and based on the potential impact of the partial clinical hold on the timing of the company’s pre-NDA meeting with the FDA, Epizyme now plans to submit its NDA in the first half of 2019.

DLBCL Program Update

Epizyme has been conducting a Phase 2 trial that is assessing tazemetostat activity in cohorts of patients with relapsed and/or refractory diffuse large B-cell lymphoma (DLBCL). These cohorts include DLBCL patients with EZH2 activating mutations and with wild-type EZH2 who are receiving tazemetostat as monotherapy. The trial also includes a cohort of DLBCL patients who are receiving tazemetostat in combination with prednisolone. Epizyme has conducted an interim assessment of data from this trial and concluded that the clinical activity seen in these cohorts is not sufficient to warrant further development of tazemetostat in DLBCL as a monotherapy or in combination with prednisolone. Epizyme plans to present clinical data from each of these study cohorts at a medical meeting in the second half of 2018. The company has two additional combination studies in DLBCL ongoing and plans to evaluate other potential combinations in this aggressive and difficult-to-treat cancer longer term.

Recent Progress

New Chief Medical Officer: Epizyme recently appointed Dr. Shefali Agarwal as chief medical officer. In this role, Dr. Agarwal will oversee all of the company’s activities related to the global strategic development of tazemetostat and additional pipeline candidates. A trained medical oncologist, Dr. Agarwal brings to Epizyme nearly two decades of clinical research and regulatory expertise as well as leadership experience in clinical development, clinical operations and medical affairs.

Positive Data in Follicular Lymhoma (FL): At the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Stockholm, positive interim data were reported from the follicular lymphoma cohorts in Epizyme’s ongoing Phase 2 study of tazemetostat in non-Hodgkin lymphoma. The data as of May 1, 2018 showed that tazemetostat continued to demonstrate meaningful clinical activity as a monotherapy and was generally well tolerated in adult patients with relapsed and/or refractory FL. An objective response rate (ORR) of 71 percent was observed in the cohort of FL patients with EZH2 activating mutations (n=28), with an interim median duration of response (DOR) of approximately 32 weeks. An ORR of 33 percent was observed in the fully-enrolled cohort of FL patients with wild-type EZH2 (n=54), with an interim median DOR of approximately 76 weeks. The median DOR figures in these cohorts continue to mature, with more than half of the responders still on therapy. After resolving the partial clinical hold, Epizyme plans to re-engage with the FDA to refine the company’s registration plans for tazemetostat in relapsed and/or refractory FL.

Clinical Activity in Mesothelioma: At the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, clinical data were reported from Epizyme’s Phase 2 study of tazemetostat as a monotherapy in relapsed and/or refractory malignant mesothelioma patients with BRCA1-associated protein 1 (BAP1) loss-of-function. The primary endpoint in this trial was met with 51 percent of patients (31/61) having achieved disease control at 12 weeks, exceeding the pre-specified disease control rate threshold of ³35 percent. Tazemetostat was generally well tolerated in this study.

Second Quarter 2018 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $215.6 million as of June 30, 2018, which compares to $247.9 million as of March 31, 2018.

Revenue: Revenue for the second quarter of 2018 was $12.0 million, which compares with $10.0 million in revenue for the second quarter of 2017. The increase is due to greater milestone-related revenue from the company’s collaboration and license agreement with GlaxoSmithKline.

R&D Expenses: Research and development (R&D) expenses were $31.3 million for the second quarter of 2018, which compares to $27.3 million for the second quarter of 2017. The increase is primarily due to greater tazemetostat manufacturing expense, increased clinical and regulatory activities associated with tazemetostat’s development and preclinical studies related to the company’s G9a inhibitor candidate.

G&A Expenses: General and administrative (G&A) expenses were $10.9 million for the second quarter of 2018, which compares to $11.2 million for the second quarter of 2017. The decline is primarily due to reduced consulting costs.

Net Loss: The company’s net loss was $29.1 million, or $0.42 per share, for the second quarter of 2018, which compares to a net loss of $28.0 million, or $0.48 per share, for the second quarter of 2017.

Financial Guidance

Epizyme has extended its cash runway guidance based on changes that are being made to its planned operating expenditures. The company now expects that its existing cash, cash equivalents and marketable securities will be sufficient to fund its planned operations into the fourth quarter of 2019.

Conference Call Reminder

As previously announced, management plans to host a conference call and webcast at 8:30 a.m. ET today to discuss the company’s second quarter 2018 results and other business updates. To participate, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 5734199. A live webcast will be available in the investor section of the company’s website at www.epizyme.com. The webcast also will be archived on the website for 60 days.

About the Tazemetostat Clinical Trial Program

Tazemetostat, a first-in-class EZH2 inhibitor, is currently being studied as a monotherapy in ongoing Phase 2 programs in certain molecularly defined solid tumors, including epithelioid sarcoma and other INI1-negative tumors; follicular lymphoma (FL); and combination studies in diffuse large B-cell lymphoma (DLBCL) and non–small cell lung cancer (NSCLC).

On August 2, 2018 Medivir AB (Nasdaq Stockholm: MVIR) reported that the first patient has been enrolled and is being dosed with remetinostat gel 1% in an investigator-initiated phase II clinical study in patients with basal cell carcinoma (BCC) (Press release, Medivir, AUG 2, 2018, View Source [SID1234528308]). This clinical study will be conducted at the Stanford University School of Medicine in California, USA under the leadership of the principal investigator, Dr Kavita Sarin. Medivir will be providing remetinostat drug supply for this study, and will have full access to, and the rights to use, all clinical data after the study is complete.

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The primary objective of the study is to assess the effects of topical remetinostat on the overall response rate in a cohort of BCC patients and could establish that remetinostat has the potential for use in other skin-associated cancers in addition to CTCL. Further details of the study can be found at www.clinicaltrials.gov with the reference NCT03180528.

"This study highlights the potential of remetinostat to be used in conditions beyond early-stage cutaneous T-cell lymphoma," said Christine Lind, CEO of Medivir. She continues, "We look forward to the completion of the study and communication of the clinical outcomes."

For further information, please contact:
Christine Lind, CEO, Medivir AB, phone: +46 (0)8 5468 3100
Erik Björk, CFO, Medivir AB, mobile: +46 (0)72 228 2831

About remetinostat
Remetinostat is a histone deacetylase (HDAC) inhibitor. The unique design of remetinostat enables topical application, making it active only in the skin. As soon as it reaches the blood stream, it is degraded, avoiding the side effects associated with other HDAC inhibitors.