TG Therapeutics, Inc. to Host Conference Call on Third Quarter 2017 Financial Results and Business Update

On November 6, 2017 TG Therapeutics, Inc. (NASDAQ:TGTX), reported that a conference call will be held on Wednesday, November 8, 2017 at 8:30am ET to discuss results for the third quarter of 2017 and provide a business outlook for the remainder of the year (Press release, TG Therapeutics, NOV 6, 2017, View Source [SID1234521589]). Michael S. Weiss, Executive Chairman and Chief Executive Officer, will host the call.

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To participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics Third Quarter 2017 Earnings Call. A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at www.tgtherapeutics.com. An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call.

TG Therapeutics will announce its financial results for this period in a press release to be issued prior to the call.

ERYTECH Reports Third Quarter 2017 Financial Results and Provides Business Update

On November 6, 2017 ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY) (Euronext Paris: ERYP) (ADR: EYRYY), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells (“ERYTECH” or the “Company”), reported a business update and its financial results for the quarter ended September 30, 2017

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Business Highlights

In September 2017, ERYTECH presented full results from its open-label, multi-center, randomized Phase 2b trial of eryaspase in combination with chemotherapy for the treatment of second-line metastatic pancreatic cancer at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress in Madrid. In October 2017, the Company met with the FDA to discuss further development of eryaspase for the pancreatic cancer indication and intends to meet with the EMA to also discuss the design of a Phase 3 clinical trial that the Company hopes to initiate during the third quarter of 2018. The Company expects that the Phase 3 clinical trial will be designed to study the safety and efficacy of eryaspase combined with chemotherapy in patients with second-line metastatic pancreatic cancer. The trial is expected to enroll approximately 400 to 600 patients across clinical sites in the United States and Europe. The Company expects the primary endpoint of the trial to measure overall survival, and the main secondary endpoints will include progression-free survival, objective response rate, disease control rate, quality of life and safety. ERYTECH is also considering proof-of-concept studies in first-line pancreatic cancer and other settings and has initiated further preclinical work to assess the combinability of eryaspase with other compounds used in the treatment of first-line pancreatic cancer patients.

In October 2017, the Company resubmitted its MAA for eryaspase (GRASPA) for the treatment of patients with R/R ALL to the EMA. The validation of the MAA by the EMA is ongoing, after which the EMA will begin its formal assessment.

In September 2017, the Company announced the determination of the recommended Phase 2 dose in its U.S. Phase 1 dose escalation trial of eryaspase (GRASPA) as a first-line treatment of adult ALL patients at the level of 100 U/kg. This dose had been previously recommended following ERYTECH’s Phase 2 trial in elderly ALL patients. It is also the dose level used in the Company’s Phase 2b trial in second-line, metastatic pancreatic cancer and in its ongoing Phase 2b trial in AML, from which top-line results are expected by the end of 2017.

Preclinical development activities of other product candidates are progressing:
In September, ERYTECH presented preclinical data on its eryminase and erymethionase programs at the 13th International Congress of Inborn Errors of Metabolism (ICIEM). Both programs underscore ERYTECH’s opportunities with companies active in the field of metabolic diseases and enzyme replacement therapies. Further proof of concept data are expected during the course of 2018.

ERYTECH continues to explore the use of its proprietary ERYCAPS platform to encapsulate tumor antigens within red blood cells as an innovative approach to cancer immunotherapy. The Company expects to complete preclinical proof-of-concept studies of ERYMMUNE during the course of 2018.
Financial Highlights

Net loss for the nine-month period ended September 30, 2017 was €20.8 million, compared to €16.1 million for the same period in the prior year. The €4.7 million increase reflected increased activity to advance the Company’s ongoing preclinical and clinical development programs and was primarily related to the clinical and regulatory progress of product development projects, and higher personnel costs incurred due to the previously announced staffing of key positions in the Company’s preclinical, clinical and pharmaceutical operations, to address the Company’s activity expansion and prepare the Company for the next stages of its development strategy.

As of September 30, 2017, ERYTECH had cash and cash equivalents totaling €80.3 million, compared with €88.6 million as of June 30, 2017 and €37.6 million as of December 31, 2016. Total net cash utilization was €8.3 million in the third quarter of 2017 and €22.8 million for the nine-month period ended September 30, 2017, excluding the €65.2 million net proceeds from the Company’s April 2017 capital raise.

The financial results for the three and nine months ended September 30, 2017 were in line with ERYTECH’s established strategy for 2017 and reflected the strengthening of the Company’s operations, which focuses on preparing the Company for its next stage of development, including its expected launch in 2018 of a Phase 3 clinical trial in second line metastatic pancreatic cancer in Europe and the United States. Management believes that its cash and cash equivalents available at September 30, 2017 are sufficient to fund our clinical trials that have already commenced, on the basis of its current cost structure and its ongoing programs, to ensure its viable going concern through the 2020 horizon.

Key newsflow and milestones expected over the next 12 months

Expect to report results from EU Phase 2b AML study in Europe
Meeting with CHMP on PDAC development plan
Meeting with FDA on ALL development plan
Potential initiation of Phase 3 trial in second-line PDAC in Europe and the U.S.
Potential initiation of clinical studies in first-line PDAC and other solid tumors
Potential launch of Phase 3 trial in first-line adult ALL
Potential launch of Phase 3 trial in AML
Expected initiation of erymethionase Phase 1 study

Next financial updates:

Financial highlights for the 4th quarter and full-year 2017: March 12, 2018 (after market close), followed by a conference call and webcast on March 13, 2018 (1:30pm CET/8:30am EDT)
Upcoming participations at investor conferences:

Jefferies Global Healthcare Conference, November 15-16, 2017, London
Actionaria, November 23-24, 2017, Paris
Geneva European Midcap Event, November 28-29, Geneva
Biomed Invest Securities, December 19, Paris
Investor access event at the J.P. Morgan Healthcare Conference, January 8-11, 2018, San Francisco
ODDO BHF Forum, January 11-12, 2018, Lyon

10-Q – Quarterly report [Sections 13 or 15(d)]

Xoma has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Xoma, 2017, NOV 6, 2017, View Source [SID1234521616]).

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TRILLIUM THERAPEUTICS TO PRESENT AT UPCOMING SCIENTIFIC CONFERENCES

On November 6, 2017 Trillium Therapeutics Inc. (Nasdaq/TSX: TRIL) a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported that the company is scheduled to present an update on the company’s programs and progress at several upcoming scientific conferences (Press release, Trillium Therapeutics, NOV 6, 2017, View Source [SID1234521590]).

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Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 32nd Annual Meeting
Presenter: Lisa Johnson, Ph.D., Trillium Research Scientist
Title: The checkpoint inhibitor TTI-621 (SIRPaFc) stimulates innate and adaptive immune responses in patients with hematologic and solid tumor malignancies (P42)
Date and Time: Nov. 11, 2017 at 12:30 p.m. – 2:00 p.m. and 6:30 p.m. – 8:00 p.m. ET
Location: Gaylord National Hotel and Convention Center, National Harbor Maryland

Presenter: Lei Cui, Ph.D., Trillium Postdoctoral Research Fellow
Title: The anti-tumor effect of radiation therapy is enhanced with the addition of TTI-621 (SIRPaFc), an immune checkpoint inhibitor blocking the CD47 "do not eat" signal (P272)
Date and Time: Nov. 11, 2017 at 12:30 p.m. – 2:00 p.m. and 6:30 p.m. – 8:00 p.m. ET
Location: Gaylord National Hotel and Convention Center, National Harbor Maryland

Society for Neuro Oncology 22nd Annual Meeting
Presenter: Zezhou Wang, Ph.D., Trillium Research Scientist

Title: TTI-2341: A novel, orally bioavailable, brain-penetrant, covalent epidermal growth factor receptor (EGFR) inhibitor for treatment of glioblastoma multiforme (GBM) and brain metastases of non-small cell lung cancer (NSCLC)
Date and Time: Nov. 18, 2017 at 5:00 p.m. – 7:00 p.m. PT,
Location: Marriott Marquis, San Francisco, California

American Society of Hematology 59th Annual Meeting
Presenter: Stephen Ansell, M.D., Ph.D., Division of Hematology, Mayo Clinic
Title: TTI-621 (SIRPaFc), an Immune Checkpoint Inhibitor Blocking the CD47 "Do Not Eat" Signal, Induces Objective Responses in Patients with Advanced, Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Date and Time: Dec. 11, 2017 at 6:00 p.m. – 8:00 p.m. ET
Location: Building A, Level 1, Hall A2, Georgia World Congress Center, Atlanta, Georgia

Presenter: Christiane Querfeld, M.D., Ph.D., City of Hope National Medical Center
Title: A Single Direct Intratumoral Injection of TTI-621 (SIRPaFc) Induces Antitumor Activity in Patients with Relapsed/Refractory Mycosis Fungoides and Sézary Syndrome: Preliminary Findings Employing an Immune Checkpoint Inhibitor Blocking the CD47 "Do Not Eat" Signal
Date and Time: Dec. 11, 2017 6:00 p.m. – 8:00 p.m. ET,
Location: Building A, Level 1, Hall A2, Georgia World Congress Center, Atlanta, Georgia

Diplomat Announces 3rd Quarter Financial Results

On November 6, 2017 Diplomat Pharmacy, Inc. (NYSE: DPLO), the nation’s largest independent provider of specialty pharmacy services, reported financial results for the quarter ended September 30, 2017 (Press release, Diplomat Speciality Pharmacy, NOV 6, 2017, View Source [SID1234521604]). All comparisons, unless otherwise noted, are to the quarter ended September 30, 2016.

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Diplomat Specialty Pharmacy (PRNewsFoto/Diplomat Pharmacy, Inc.)

Third Quarter 2017 Highlights include:

Revenue of $1,125 million, compared to $1,181 million
Total prescriptions dispensed of 222,000, compared to 266,000
Gross margin of 7.6% versus 6.6%
Gross profit per prescription dispensed of $360, compared to $289
Net income attributable to Diplomat of $1.0 million, compared to $5.4 million
Adjusted EBITDA of $23.2 million, compared to $22.6 million
Adjusted EBITDA margin of 2.1% versus 1.9%
EPS of $0.01 per diluted common share versus $0.08
Adjusted EPS of $0.25 versus $0.21
Phil Hagerman, CEO and Chairman of Diplomat, commented “Diplomat’s third quarter results were solid as we achieved financial results in-line with our expectations, experienced continued growth in our oncology and infusion businesses and expansion in our access to limited distribution drugs, as well as encouraging trends within the specialty pharmacy industry. I am pleased to announce we have resolved our arbitration with CVS and have transitioned from a PSAO contract to a direct contract with CVS, one of the nation’s largest health care companies. 2017 is a transition year for Diplomat, and we continue to make significant strides, including broadening our services through our acquisitions of NPS and 8th Day Software and enhancing our senior management team to execute on our strategy to become a broader-based health care company.”

Third Quarter Financial Summary:

Revenue for the third quarter of 2017 was $1,125 million, compared to $1,181 million in the third quarter of 2016. The decrease was driven by a loss of approximately $118 million due to contracts that were not renewed in 2017 and approximately $89 million due to a decrease in the demand for hepatitis C drugs versus the prior year period. These decreases were partially offset by approximately $64 million from the impact of manufacturer price increases, approximately $47 million from increased volume and mix with existing payor contracts, approximately $25 million of revenue from our recent acquisitions, and approximately $15 million from drugs that were new in the past year. Our revenue increase year over year excluding the impact of the contract losses was approximately 6%.

Gross profit in the third quarter of 2017 was $85.3 million and generated a 7.6% gross margin, compared to $78.5 million and 6.6% in the third quarter of 2016. The gross margin increase in the quarter was primarily due to the continued growth of our specialty infusion therapeutic category, the impact of our WRB Communications acquisition, each having higher margins, the receipt and recognition of approximately $1 million of insurance proceeds, and the non-repeat of an approximately $4 million direct and indirect remuneration (“DIR”) fee true-up that occurred in the year ago period.

Selling, general, and administrative expenses (“SG&A”) for the third quarter of 2017 were $83.0 million, an increase of $5.9 million, compared to $77.1 million in the third quarter of 2016. Of this change, $4.9 million related to employee cost, of which $5.2 million was employee cost for our recently acquired entities partially offset by operational efficiencies. Also contributing to the SG&A increase was a $2.4 million increase in amortization expense from definite-lived intangible assets, and a $1.9 million increase in the fair value of contingent consideration, both of which are associated with our acquired entities. We also experienced increases in other SG&A; including professional fees, workers’ compensation insurance, and other miscellaneous expenses. These increases were partially offset by the non-repeat of a $4.8 million impairment expense to fully impair certain definite-lived intangible assets in the prior year period. As a percentage of revenue, SG&A excluding change in fair value of contingent consideration and the prior year period impairment was 7.2% for the three months ended September 30, 2017, compared to 6.1% in the prior year period. This increase is primarily attributable to acquisition related amortization, professional fees, and the increased operating complexity associated with both our acquisitions and new drugs.

Net income attributable to Diplomat for the third quarter of 2017 was $1.0 million compared to $5.4 million in the third quarter of 2016. This decrease was primarily driven by the revenue, gross profit, and SG&A explanations above, as well as a $2.6 million change in income taxes. Adjusted EBITDA for the third quarter of 2017 was $23.2 million compared to $22.6 million in the third quarter of 2016.

Earnings per share for the third quarter of 2017 was $0.01 per basic/diluted common share, compared to $0.08 per basic/diluted common share for the third quarter of 2016. Diluted non-GAAP adjusted earnings per share (“Adjusted EPS”) was $0.25 in the third quarter of this year compared to $0.21 in the third quarter of 2016.

2017 Financial Outlook

For the full-year 2017, we are updating our previous financial guidance:

Revenue between $4.4 and $4.6 billion, versus the previous range of $4.3 and $4.6 billion
Net income attributable to Diplomat between $10 and $14 million, versus the previous range of $10 and $16 million
Adjusted EBITDA between $99 and $102 million, versus the previous range of $97 and $103 million
Diluted EPS between $0.15 and $0.20, versus the previous range of $0.15 and $0.23
Adjusted EPS between $0.82 and $0.87, versus the previous range of $0.71 and $0.79
Our EPS and Adjusted EPS expectations assume approximately 68,600,000 weighted average common shares outstanding on a diluted basis and a tax rate of 19%, versus the previous tax rate of 26%, for the full year 2017, which could differ materially.

Earnings Conference Call Information

As previously announced, the Company will hold a conference call to discuss its third quarter performance this evening, November 6, 2017, at 5:00 p.m. Eastern Time. Shareholders and interested participants may listen to a live broadcast of the conference call by dialing 833-286-5805 (or 647-689-4450 for international callers) and referencing participant code 95696083 approximately 15 minutes prior to the call. A webcast and audio file of the conference call will be available on the investor relations section of the Company’s website for approximately 90 days at ir.diplomat.is.