Marker Therapeutics to Present at Three Upcoming Healthcare Conferences

On November 8, 2018 Marker Therapeutics, Inc. (NASDAQ: MRKR), a clinical-stage immuno-oncology company, reported that its President and CEO, Peter L. Hoang, will participate in three upcoming healthcare conferences. Mr. Hoang will participate in a panel discussion titled "Drug Pricing and Development Challenges" at the CEO Life Sciences and Pharmaceuticals Symposium on November 13, 2018 in New York City, and will give corporate overviews at the Piper Jaffray 30th Annual Healthcare Conference on November 27, 2018 in New York City and at the Evercore ISI HealthconX Conference on November 28, 2018 in Boston (Press release, Marker Therapeutics, NOV 8, 2018, View Source [SID1234530974]).

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November Conferences
November Conferences
CEO Life Sciences and Pharmaceuticals Symposium
Title: Drug Pricing and Development Challenges
Date: Tuesday, November 13, 2018
Time: 5:00pm – 6:30pm (EST)
Location: Yellow Room, 107 East 16th Street, New York City

Piper Jaffray 30th Annual Healthcare Conference
Date: Tuesday, November 27, 2018
Time: 12:00pm – 12:25pm (EST)
Location: Lotte New York Palace, Holmes 1, 4th Floor

Evercore ISI HealthconX Conference
Date: Wednesday, November 28, 2018
Time: 10:35am – 10:55am (EST)
Location: Boston Harbor Hotel, South Atlantic Room, 2nd Floor

Webcasts for the Piper Jaffray and Evercore ISI conferences will be made available at View Source

Stemline Therapeutics Reports Third Quarter 2018 Financial Results

On November 8, 2018 Stemline Therapeutics, Inc. (Nasdaq: STML), a biopharmaceutical company focused on the development and potential commercialization of novel oncology therapeutics, reported financial results for the quarter ended September 30, 2018 (Press release, Stemline Therapeutics, NOV 8, 2018, View Source [SID1234531049]). The Company also reviewed recent clinical and regulatory events, and outlined key upcoming milestones:

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ELZONRIS – Potential Approval and Pre-Commercial Activities

The FDA accepted, for filing, the Company’s Biologics License Application (BLA) for ELZONRISTM (tagraxofusp; SL-401) for the treatment of patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). The FDA also granted Priority Review for the BLA and set a target action date of February 21, 2019, under the Prescription Drug User Fee Act (PDUFA).
In preparation for potential US approval, we continue to build out our pre-launch activities. These efforts include ramping up our disease awareness campaign targeting key stakeholders including hematologist-oncologists, dermatologists, and pathologists.
During the quarter, we conducted meetings with our assigned Rapporteurs and the European Medicines Agency (EMA). Based on feedback from these meetings, we plan to submit a Marketing Authorization Application (MAA) to the EMA for ELZONRIS in the first quarter of 2019 seeking marketing approval in Europe.
ELZONRIS – Market Expansion Efforts

ELZONRIS is being evaluated in clinical trials in additional indications, with a focus on chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF).
Based on the clinical results observed in CMML and MF thus far, we are finalizing registrational plans in these indications. We plan to seek regulatory advice in early 2019 with the goal of initiating pivotal trials, or cohorts, to follow. Ahead of this, the ongoing trial continues to enroll CMML and MF patients, and periodic updates at upcoming conferences will be provided.
ASH Conference

At the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) conference in December, ELZONRIS data were selected for four presentations, including an oral presentation. Presentations include results of the BPDCN pivotal trial and updated clinical trial data in patients with chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF).
Additionally, we expect to have a robust clinical, medical affairs and pre-commercial presence at ASH (Free ASH Whitepaper), including hosting an investor/analyst event on December 3rd.
SL-801

In October, data from the ongoing Phase 1 trial of SL-801 in patients with advanced solid tumors were presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress 2018.
Patient enrollment and dose escalation continues. We expect to provide further updates at upcoming conferences.
SL-701

In October, data from the Phase 2 trial of SL-701 in patients with second-line glioblastoma (GBM) were delivered via oral presentation at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress 2018.
Discussions around next steps to unlock potential value from the program are ongoing, and we expect to provide further updates at upcoming conferences.
Ivan Bergstein, M.D., CEO of Stemline Therapeutics, commented "This is an extremely exciting time for Stemline, as we gear up for the possible approval and near-term launch of ELZONRIS for BPDCN. We have nearly completed the full build-out of our U.S. sales force and commercial infrastructure in preparation for potential launch of ELZONRIS. In parallel, we continue to generate very promising clinical data in CMML and MF, additional areas of unmet medical need. Overall, the ability to effectively target CD123 with an acceptable safety profile we believe opens up significant developmental and commercial opportunities for Stemline."

Third Quarter 2018 Financial Results Review

Stemline ended the third quarter of 2018 with $78.5 million in cash, cash equivalents and investments, representing cash use of $18.6 million in the third quarter. The Company ended the third quarter of 2018 with 31.7 million shares outstanding. For the third quarter of 2018, Stemline had a net loss of $21.0 million, or $0.73 per share, compared with a net loss of $16.1 million, or $0.68 per share, for the same period in 2017.

Research and development expenses were $11.8 million for the quarter ended September 30, 2018, compared with $12.4 million for the quarter ended September 30, 2017.

General and administrative expenses were $9.6 million for the quarter ended September 30, 2018, compared with $4.2 million for the quarter ended September 30, 2017, representing an increase of $5.4 million. The higher expenses were primarily attributed to a $4.6 million increase in pre-launch expenses to support a potential commercialization of ELZONRIS in BPDCN, if marketing approval from the FDA is obtained. Additionally, the higher expense was also due to an increase in non-cash stock-based compensation and increased headcount.

About BPDCN
Please visit the BPDCN disease awareness booth (#205) at ASH (Free ASH Whitepaper) 2018, and the BPDCN disease awareness website at www.bpdcninfo.com.

Coherus BioSciences Reports Corporate Highlights and Third Quarter 2018 Financial Results

On November 8, 2018 Coherus BioSciences, Inc. (Nasdaq: CHRS), reported financial results for the quarter ended September 30, 2018 (Press release, Coherus Biosciences, NOV 8, 2018, View Source/news-releases/news-release-details/coherus-biosciences-reports-corporate-highlights-and-third" target="_blank" title="View Source/news-releases/news-release-details/coherus-biosciences-reports-corporate-highlights-and-third" rel="nofollow">View Source [SID1234531695]).

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Third Quarter 2018 and Recent Corporate Highlights Include:

On September 25, 2018, the European Commission (EC) approved UDENYCA by granting marketing authorization in all European Union member states.
On November 2, 2018, the U.S. Food and Drug Administration (FDA) approved UDENYCA (pegfilgrastim-cbqv) for patients with cancer receiving myelosuppressive chemotherapy. UDENYCA is Coherus’ first drug to receive FDA or EC approval.
In preparation for a comprehensive launch of UDENYCA, Coherus completed the hiring of about 70 sales representatives covering seven territories as well as the hiring of other personnel for our commercial groups and teams.
Third Quarter 2018 Financial Results:
Research and development (R&D) expenses for the third quarter of 2018 were $31.6 million compared to $42.6 million for the same period in 2017. R&D expenses for the nine months ended September 30, 2018 were $83.6 million, as compared to $130.9 million for the same period in 2017. The decreases in R&D expenses were mainly due to the completion of our clinical trials and related manufacturing for the immunology biosimilar drug candidates, CHS-1420 (adalimumab (Humira) biosimilar) and CHS-0214 (etanercept (Enbrel) biosimilar). These cost decreases were partially offset by the costs associated with the manufacturing of UDENYCA.
General and administrative (G&A) expenses for the third quarter of 2018 were $25.4 million, compared to $14.0 million for the same period in 2017. G&A expenses for the nine months ended September 30, 2018 were $60.3 million, as compared to $56.3 million for the same period in 2017. The increases in G&A expenses in 2018 were mainly attributable to the costs associated with hiring a sales force and completing the commercial infrastructure to launch and sell UDENYCA in the U.S.
Net loss attributable to Coherus for the third quarter of 2018 was ($58.8) million, or ($0.87) per share, compared to a net loss of ($59.0) million, or ($1.09) per share, for the same period in 2017.
Cash and cash equivalents and investments in marketable securities – totaled $117.2 million as of September 30, 2018, compared to $159.8 million as of June 30, 2018. Cash use in operations of $42.8 million during the third quarter of 2018 was lower than guidance of $48 to $53 million.

Guidance for next twelve months from September 30, 2018:
UDENYCA (pegfilgrastim-cbqv), Neulasta biosimilar

Anticipate U.S. commercial launch in January 2019.
CHS-1420 (adalimumab (Humira) biosimilar)

Pursue manufacturing objectives in support of the anticipated filing of a 351(k) biologic license application (BLA) in the U.S. at the end of 2019.
CHS-3351 (ranibizumab (Lucentis) biosimilar) and CHS-2020 (aflibercept (Eylea) biosimilar)

Complete manufacturing technology transfer and continue clinical development of CHS-3351.
Continue preclinical development of CHS-2020.
CHS-131 (small molecule drug candidate in nonalcoholic steatohepatitis "NASH")

Anticipate initiation of Phase 2 clinical trial in NASH.
Conference Call Information

When: Thursday, November 8, 2018 at 4:30 p.m. ET

Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)

Conference ID: 7181479

Webcast: View Source

Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.

Bicycle Therapeutics to Present at Jefferies 2018 London Healthcare Conference

On November 8, 2018 Bicycle Therapeutics, a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptide (Bicycle) product platform, reported that management will present a company update at the Jefferies 2018 London Healthcare Conference (Press release, Bicycle Therapeutics, NOV 8, 2018, View Source [SID1234530956]). The presentation will take place at 5:20 p.m. GMT on Thursday, November 15, 2018.

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Perrigo Company plc Reports Third Quarter 2018 Financial Results

On November 8, 2018 Perrigo Company plc (NYSE; TASE: PRGO) reported financial results for the third quarter ended September 29, 2018 (Press release, Perrigo Company, NOV 8, 2018, View Source [SID1234530975]).

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Refer to Tables I – VI at the end of this press release for a reconciliation of non-GAAP measures to the current year and prior year periods and additional non-GAAP information. The Company’s reported results are included in the attached Condensed Consolidated Statements of Operations, Balance Sheets and Statements of Cash Flows.

Reported net sales for the third quarter of calendar year 2018 were approximately $1.1 billion, which included new product sales of $35 million, partially offset by discontinued products of $9 million. Adjusted net sales decreased 5.7% on a constant currency basis. Unfavorable currency movements impacted net sales by $12 million.

Reported net loss was $68 million, or $0.49 per diluted share, versus net income of $45 million, or $0.31 per diluted share, in the prior year. Excluding charges as outlined in Table I, third quarter 2018 adjusted net income was $150 million, or $1.09 per diluted share, versus adjusted net income of $197 million, or $1.39 per diluted share, for the same period last year.

CHC Americas segment reported net sales were relatively flat compared to last year. Strong net sales in the smoking cessation, infant formula and dermatological categories coupled with new product sales of $13 million, were offset by lower net sales in the animal health and gastrointestinal categories and discontinued products of $1 million. Excluding the animal health business, net sales in the CHC Americas segment grew approximately 3%, on a constant currency basis.

CHC Americas third quarter reported gross profit margin was 31.0%. Adjusted gross profit margin was 32.7%, lower than the prior year due primarily to the animal health business, operating inefficiencies and relatively higher input costs.

Reported third quarter operating margin was (20.8)%. Third quarter adjusted operating margin was 19.0%, lower than the prior year due primarily to adjusted gross margin flow through.

CHC International net sales increased approximately 1%, excluding $2 million in net sales from exited businesses in 2017 and unfavorable foreign currency movements of $10 million. Growth was driven by net sales in the analgesic, anti-parasite and personal care categories in addition to new product sales of $19 million. Partially offsetting this growth were lower net sales in the lifestyle category and non-branded U.K. businesses. Discontinued products were $5 million.

Third quarter reported gross margin was 46.6%. Adjusted gross margin increased 120 basis points over the previous year to 52.6%, driven primarily by adjusted gross margin improvement initiatives including new product margin contributions.

Reported operating margin was (0.6)%. Adjusted operating margin expanded 230 basis points to 18.7% driven by gross margin flow through and improved operating leverage
RX reported net sales of $179 million were lower due primarily to challenging market dynamics in a number of authorized generic products and customer service challenges, resulting in lower sales volumes. Discontinued products were $4 million.

Reported gross margin was 41.0%. Adjusted gross margin was 52.3%, 260 basis points lower than the same quarter last year, due primarily to unfavorable product mix.

Reported operating margin was 20.1%. Adjusted operating margin was 31.9% compared to 42.4% in the prior year, due primarily to a 580 basis points increase in R&D investments as a percentage of net sales, compared to the prior year and adjusted gross margin flow through. R&D as a percentage to net sales was approximately 11% in the quarter.

Impairment

During the three months ended September 29, 2018, the animal health reporting unit continued to experience declines in its year-to-date financial results and had additional indications of impairment due to changes in channel dynamics, a strategic decision to re-prioritize our brands, and a decline in the forecasted outlook of the reporting unit. As a result, the Company realized an impairment in goodwill and intangible assets in this reporting unit within CHC Americas of approximately $213 million.

Guidance

The Company now expects calendar year 2018 net sales to be approximately $4.72 billion. The Company also expects calendar year 2018 adjusted diluted EPS in the range of $4.45 to $4.65, primarily due to revised expectation in the RX segment. In addition, reduced margin expectations in the CHC Americas segment are expected to be partially offset by improved margin expectations in the CHC International segment.

Conference Call

The Company will host a conference call at 8:30 a.m. EST (5:30 a.m. PDT), November 8, 2018. The conference call will be available live via webcast to interested parties in the investor relations section of the Perrigo website at View Source or by phone at 888-317-6003, International 412-317-6061, and reference ID #4651574. A taped replay of the call will be available beginning at approximately 12:00 p.m. (EST) Thursday, November 8, until midnight November 15, 2018. To listen to the replay, dial 877-344-7529, International 412-317-0088, and use access code 10125751.