On August 9, 2019 SHINE Medical Technologies LLC reported it has received a $15-million award from the Department of Energy’s National Nuclear Security Administration (DOE/NNSA) (Press release, Shine Medical Technologies, AUG 9, 2019, View Source;pk_kwd=15-million-doe-nnsa-award-for-production-of-medical-isotope [SID1234540974]). The award was made by the agency as part of its effort to establish a reliable, U.S.-produced supply of molybdenum-99 (Mo-99), the most commonly used medical isotope, without the use of highly enriched uranium. The cooperative agreement with the DOE/NNSA requires SHINE to provide $15 million of matching funds.

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Medical isotopes are used in heart stress tests, cancer staging and therapeutics, and other medical applications. Chronic global shortages of Mo-99 routinely and significantly affect the diagnosis and treatment of patients in the United States and around the world.

SHINE broke ground in May on an isotope production facility in Janesville, Wisconsin. It will be the first facility of its kind in the world, using the company’s patented technology to produce Mo-99 and other isotopes used in more than 40 million procedures every year. When the facility becomes operational after the company receives approval to operate from the Nuclear Regulatory Commission (NRC), the plant will be capable of producing the majority of U.S. demand for Mo-99. The NRC’s review is expected to take up to 24 months from its acceptance of SHINE’s application.

"We are grateful for DOE/NNSA’s award as SHINE continues its progress toward production of Mo-99 and other important medical isotopes," said Greg Piefer, SHINE’s founder and CEO. "SHINE’s recently-submitted operating license application to the NRC brings us one step closer to that goal. The recent DOE/NNSA award directly supports SHINE’s continued advancement as we work to supply lifesaving medical tracers and therapeutics to an underserved, growing global market."

About Medical Isotopes
Medical isotopes are radioisotopes that are used in the diagnosis and treatment of disease. Molybdenum-99 (Mo-99) is a radioisotope that decays into the diagnostic imaging agent technetium 99m (Tc-99m). The workhorse of nuclear medicine, Tc-99m is used in more than 40 million medical imaging procedures each year, primarily in stress tests to diagnose heart disease and to stage cases of cancer. SHINE was founded to deploy a safe, cost-effective and environmentally friendly technology to produce a variety of medical isotopes, including Mo-99. Roughly one percent of all Mo-99 in the world decays every hour, meaning it must be produced continuously. Current production is limited to only a handful of government-owned nuclear research reactors, the majority of which are overseas.

On August 9, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its financial results for the second quarter ended June 30, 2019 and recent company developments (Press release, TG Therapeutics, AUG 9, 2019, View Source [SID1234538544]).

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Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, "As we enter into the second half of the year, we are pleased with the progress made thus far and excited for the upcoming milestones. With a well-defined path to a regulatory submission for umbralisib in marginal zone lymphoma, we feel confident that we are at a pivotal point in our Company’s lifecycle." Mr. Weiss continued, "As we prepare for our first filing in MZL, we are also building a top-notch commercial organization which will fuel the long-term success of TG. And with pivotal data readouts also expected in CLL and MS over the next 6-12 months, we believe we are at the beginning of an extremely exciting transformational period for our Company."

Recent Developments and Highlights

Marginal Zone Lymphoma – Confirmed Registration Path: Announced confirmation of registration path to submit umbralisib for accelerated approval based on data from the marginal zone lymphoma (MZL) cohort of the UNITY-NHL Phase 2b trial.

Positive Interim Data from MZL Cohort of UNITY-NHL Trial: Presented positive interim data from the MZL cohort of the UNITY-NHL trial during oral presentations at the 55thAmerican Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting and the 2019 International Conference on Malignant Lymphoma (ICML).

Ublituximab Data in Multiple Sclerosis: Presented long-term follow-up data from the Phase 2 trial of ublituximab in patients with relapsing forms of multiple sclerosis (RMS) at the 5th Congress of the European Academy of Neurology (EAN).

Umbralisib Data in CLL and RT: Presented Phase 2 data of umbralisib in patients with chronic lymphocytic leukemia (CLL) who are intolerant to prior BTK or PI3k delta inhibitor therapy, and also presented data from patients with relapsed/refractory CLL or Richter’s Transformation (RT) treated with the triple combination of ublituximab, umbralisib and pembrolizumab.

TG-1801 Preclinical Data: Presented the first preclinical data of TG-1801, the Company’s first-in-class anti-CD47/CD19 bispecific antibody, at the 24th European Hematology Association (EHA) (Free EHA Whitepaper) annual congress.
Remaining 2019 and Early 2020 Milestones

Initiate a rolling New Drug Application (NDA) submission for patients with previously treated MZL

Present final data from the MZL cohort of the UNITY-NHL registration directed trial evaluating umbralisib in MZL

Potential top-line progression free survival (PFS) results from the Phase 3 UNITY-CLL trial evaluating U2 in patients with CLL

Present updated data from our pipeline products and combination studies at upcoming major medical conferences
Financial Results for the Three and Six Months Ended June 30, 2019

R&D Expenses: Other research and development (R&D) expense (not including non-cash compensation and non-cash in-licensing expense) was $31.4 million and $62.3 million for the three and sixth months ended June 30, 2019 compared to $34.8 million and $66.0 million for the three and six months ended June 30, 2018. The decrease in other R&D expense is primarily attributable to a decrease in clinical trial expenses of $9.7 million and $10.4 million, respectively during the three and six months ended June 30, 2019, as compared to prior periods, offset by an increase in manufacturing and CMC expenses for Phase 3 clinical trials and potential commercialization of $7.9 million and $4.7 million, respectively during the three and six months ended June 30, 2019, as compared to prior periods. The current period decrease in other R&D expenses is primarily due to full enrollment in our pivotal Phase III clinical development programs completed in the prior period. We expect other R&D expenses to decrease through the remainder of 2019.

G&A Expenses: Other general and administrative (G&A) expense (not including non-cash compensation) was $2.3 million and $4.3 million for the three and six months ended June 30, 2019 as compared to $2.3 million and $4.4 million for the three and six months ended June 30, 2018. Other G&A expenses remained relatively flat compared to the prior period, and we expect Other G&A expenses to increase modestly through the remainder of 2019.

Net Loss: Net loss was $36.2 million and $71.4 million for the three and six months ended June 30, 2019, respectively, compared to a net loss of $44.1 million and $85.7 million for the three and six months ended June 30, 2018, respectively. Excluding non-cash items, the net loss for the three and six months ended June 30, 2019 was approximately $34.4 million and $67.6 million. We expect our quarterly net loss to decrease through the remainder of 2019.

Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $85.0 million as of June 30, 2019. Pro forma cash, cash equivalents and investment securities as of June 30, 2019 (excluding our third quarter 2019 operations) are approximately $96.6 million, after giving effect to $11.6 million of net proceeds from the utilization of the Company’s at-the-market ("ATM") sales facility during the third quarter of 2019. The Company believes its cash, cash equivalents and investment securities on hand as of June 30, 2019, inclusive of the proceeds raised from the ATM facility subsequent to the second quarter, as well as future availability under the ATM facility, will be sufficient to fund the Company’s planned operations through the third quarter of 2020.
Conference Call Information

The Company will host a conference call today, August 9, 2019, at 8:30 am ET, to discuss the Company’s second quarter 2019 financial results and provide a business outlook for the remainder of 2019.

In order 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 Second Quarter 2019 Business Update Call. A live audio webcast will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source 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.

On August 9, 2019 CytRx Corporation (OTCQB: CYTR), a biopharmaceutical research and development company specializing in oncology and rare diseases, reported financial results for the second quarter ended June 30, 2019, and provided an overview of recent accomplishments (Press release, CytRx, AUG 9, 2019, View Source [SID1234538569]).

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"The first half of 2019 has been marked by significant achievements from our licensees, who continue to make progress in bringing CytRx’s technology closer to patients who are in need of novel and innovative therapies," said Eric Curtis, CytRx’s President and Chief Operating Officer. "As these partners continue to work diligently, CytRx stands to receive milestone payments and royalties, which may strengthen our balance sheet."

Second Quarter 2019 and Recent Highlights

CytRx Corporation

Orphazyme Prepares Regulatory Submission in United States and Europe for Niemann-Pick Disease Type C. In July 2019, CytRx highlighted that arimoclomol licensee Orphazyme announced that following a positive meeting with the U.S. Food and Drug Administration (FDA), the Company remains on track to submit a New Drug Application (NDA) for arimoclomol in NPC in the first half of 2020. Orphazyme also updated the anticipated timing for submission of its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval for arimoclomol in Niemann-Pick disease Type C (NPC). Based on advice received from the EMA’s Scientific Advice Working Group, Orphazyme expects to submit the arimoclomol MAA in the first half of 2020. CytRx is eligible to receive up to $120 million in future milestones, plus royalties, from its arimoclomol licensing agreement with Orphazyme. Specifically, CytRx is eligible to receive $6 million in the U.S. and $4 million in Europe upon approval of arimoclomol in Orphazyme’s first non-ALS indication, plus royalties.
Licensee Orphazyme Completed Enrollment in Phase 3 Trial of Arimoclomol in Amyotrophic Lateral Sclerosis. In July 2019, CytRx highlighted that arimoclomol licensee Orphazyme A/S (ORPH.CO) has completed enrollment in its Phase 3 trial evaluating arimoclomol for the treatment of amyotrophic lateral sclerosis (ALS) ahead of schedule. Orphazyme anticipates announcing top-line results from the Phase 3 trial in the first half of 2021.
New Patent Issued for Aldoxorubicin Formulation. In June 2019, CytRx highlighted that it has been issued a patent from the U.S. Patent and Trademark Office (USPTO) covering the formulation, storage, delivery and administration of aldoxorubicin at room temperature. The new patent, which issued on June 25, 2019 as U.S. Patent No. 10,328,093 and is titled "Anthracycline Formulations," covers a reconstituted formula of aldoxorubicin that stabilizes the compound, solubilizes it in ethanol and water, and eliminates the need for cold handling, allowing it to be administered to patients in all potential disease indications at room temperature.
CytRx Commences Trading on OTCQB Venture Market. In May 2019, CytRx announced that it commenced trading on the OTCQB Venture Market. The Company continues to trade under ticker symbol "CYTR". Investors can find current financial disclosure and real-time Level 2 quotes for the Company on www.otcmarkets.com/stock/CYTR/quote.
Patent Issued for the Use of Aldoxorubicin in the Treatment of Brain Cancer. In May 2019, CytRx announced that it had been issued a patent the USPTO covering the use of aldoxorubicin intravenously, intra-arterially or intramuscularly for the treatment of brain cancer. The new patent issued on May 7, 2019 as U.S. Patent No. 10,278,981, is titled "Cytotoxic Agents for The Treatment of Cancer." This patent was exclusively licensed by CytRx to NantCell in July 2017.
Orphazyme Completed Enrollment in its Phase 2/3 Clinical Trial in Systemic Inclusion Body Myositis. In April 2019, CytRx highlighted that arimoclomol licensee Orphazyme had completed enrollment in its Phase 2/3 clinical trial in Systemic Inclusion Body Myositis (sIBM). The Phase 2/3 trial is a 150-patient, 20-month, randomized, double-blind, placebo-controlled trial in 11 centers in the United States and one in the United Kingdom. Orphazyme expects to conduct an interim analysis in the first half of 2020 and to complete the study by the end of 2020, with results anticipated in the first half of 2021.
Second Quarter 2019 Financial Results

CytRx reported cash, cash equivalents and short-term investments of $19.4 million as of June 30, 2019.

Net loss for the quarter ended June 30, 2019 was $1.3 million, or $(0.04) per share, compared with a net loss of $ 3.0 million, or $(0.10) per share, for the quarter ended June 30, 2018, a reduction of $1.7 million.

General and administrative (G&A) expenses were $1.5 million for the second quarter of 2019, compared with $ 1.7 million for the second quarter of 2018, including non-cash stock-compensation expense of $0.2 million for the second quarter of 2019 as compared to $ 0.4 million for the second quarter of 2018. G&A expenses decreased by approximately $0.2 million, or 9.4%, primarily due to a decrease in legal fees and a reduction in head count.

Based on our currently projected expenditures for the next 13 months, our monthly cash burn rate is estimated at approximately $400,000 per month.

On August 9, 2019 Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, reported second quarter 2019 financial results (Press release, Epizyme, AUG 9, 2019, View Source [SID1234538518]).

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"Over the course of the first half of 2019, we made tremendous progress across all aspects of Epizyme’s business, and the second half of the year holds even greater opportunities as we transition to a commercial-stage company and work to achieve our Vision 2020," said Robert Bazemore, president and chief executive officer of Epizyme. "Our vision is to bring tazemetostat to both epithelioid sarcoma and follicular lymphoma patients, while also expanding its development in the future to additional tumor types and combinations, to advance research efforts to bring EZM8266 and other early programs into the clinic, and to further enhance our leadership in the field of epigenetic drug discovery and development. The milestones we have achieved so far this year, along with the anticipated clinical and regulatory catalysts over the next several months, position this to be our most significant year yet. We look forward to continuing our progress in an effort to impact the lives of as many people as we can."

Leadership Team Expansion

Epizyme recently appointed Paolo Tombesi as chief financial officer to further support the company’s transition to a commercial-stage organization. Mr. Tombesi brings over 30 years of extensive financial and accounting expertise to Epizyme, most recently serving as the chief financial officer at Insmed, Inc.

Tazemetostat for Epithelioid Sarcoma (ES)

NDA Submission Accepted for Priority Review: The U.S. Food and Drug Administration (FDA) has accepted for filing Epizyme’s New Drug Application (NDA) for accelerated approval of tazemetostat, its lead investigational agent. The company has proposed an indication for the treatment of patients with metastatic or locally advanced epithelioid sarcoma who are not eligible for curative surgery. The FDA granted Priority Review for the NDA and has set a Prescription Drug User Fee Act (PDUFA) target action date of January 23, 2020. The submission is based primarily upon data from the 62 patient ES cohort in the company’s ongoing Phase 2 trial of tazemetostat, which were recently presented at ASCO (Free ASCO Whitepaper), and the safety and tolerability data generated across the tazemetostat development program.

Confirmatory Program Anticipated to Begin in 2H 2019: Epizyme has aligned on the design of its confirmatory trial to support full approval of tazemetostat for ES. The company plans to conduct a 1:1 randomized, controlled clinical trial in the front-line treatment setting comparing tazemetostat in combination with doxorubicin, a commonly used systemic treatment in this setting, versus placebo plus doxorubicin in approximately 150 patients. The primary efficacy endpoint will be progression-free survival, and secondary efficacy endpoints will include overall survival, disease control rate, overall response rate and duration of response. The safety run-in portion of the study is expected to begin in the second half of 2019.

Tazemetostat for Follicular Lymphoma (FL)

Planned NDA Submission for All-Comer FL on Track for Fourth Quarter: Epizyme is preparing to submit an NDA for accelerated approval of tazemetostat for the treatment of adult patients with relapsed or refractory FL, regardless of their EZH2 mutational status, who have received at least two prior systemic therapies. The company expects to submit the NDA for this indication in the fourth quarter of 2019.

Positive Updated Data from Ongoing Phase 2 Trial: At ICML, Epizyme presented data from the Phase 2 study of tazemetostat, as of a June 7, 2019 data cut off, showing that patients with an EZH2 mutation (n=43) had a 77% overall response rate (ORR) and a median duration of response (DOR) of 8.3 months. Patients with wild-type EZH2 (n=53) had a mature 34% ORR and 13-month DOR. Notably, favorable safety and tolerability were observed, with treatment-related adverse events resulting in only 5% of patients discontinuing treatment due to an adverse event. Enrollment is completed and the study is ongoing.

Confirmatory Program Anticipated to Begin in 2H 2019: To support full approval, Epizyme is planning to conduct a confirmatory program with an adaptive study evaluating the combination of tazemetostat with the chemo-free treatment regimen "R2" (Revlimid plus Rituxan) in the second line or later treatment setting for FL patients, both with and without EZH2 activating mutations. The final design is subject to alignment with FDA, and the company anticipates initiating the safety run-in portion in the second half of 2019.

FL Expansion Plans Established: Multiple additional clinical studies are anticipated to begin in the second half of 2019, and are designed to evaluate tazemetostat in earlier lines of FL treatment and in new combination regimens, including:

a combination study of tazemetostat with rituximab in patients with relapsed and/or refractory FL, and

a combination study of tazemetostat with R-CHOP in front-line patients in collaboration with the Lymphoma Study Association.

Tazemetostat for Additional Solid Tumors

Epizyme is planning several proof-of-concept clinical trials to begin in the second half of 2019 intended to explore the potential of new tazemetostat combinations in multiple solid tumor cancers, including:

a combination study of tazemetostat with the standards of care in patients with castration-resistant prostate cancer, and

a combination study of tazemetostat with a PARP inhibitor in patients with platinum-resistant solid tumors, such as small-cell lung cancer, triple-negative breast cancer and ovarian cancer.

EZM8266 for Sickle Cell Disease

Epizyme anticipates beginning clinical development of EZM8266, a novel, first-in-class G9a inhibitor, with a Phase 1 clinical trial in the second half of 2019.

Second Quarter 2019 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $331.0 million as of June 30, 2019, as compared to $215.6 million as of June 30, 2018.

Revenue: Collaboration revenue for the second quarter of 2019 was $5.9 million, compared to $12.0 million for the second quarter of 2018. The collaboration revenue recognized in the second quarter of 2019 relates to revenue earned as part of the company’s collaboration with Boehringer Ingelheim. In the second quarter of 2018, Epizyme recognized a $12.0 million milestone under its agreement with GlaxoSmithKline.

R&D Expenses: Research and development (R&D) expenses were $40.9 million for the second quarter of 2019, compared to $31.3 million for the second quarter of 2018. The increase is primarily due to a $10.0 million development milestone paid to Eisai in connection with the submission of the NDA in the second quarter of 2019

G&A Expenses: General and administrative (G&A) expenses were $15.7 million for the second quarter of 2019, compared to $10.9 million for the second quarter of 2018. The increase is due primarily to increased pre-commercialization activities and staffing, as well as increased personnel related expenses.

Net Loss Attributed to Common Stockholders: Net loss attributable to common stockholders was $48.5 million, or $0.53 per share, for the second quarter of 2019, compared to $29.1 million, or $0.42 per share, for the second quarter of 2018.

Financial Guidance

Based on its current operating plan, Epizyme continues to expect its cash runway to extend into the first quarter of 2021.

The company will not hold a conference call in conjunction with these results.

On August 9, 2019 Diplomat Pharmacy, Inc. (NYSE: DPLO), the nation’s largest independent provider of specialty pharmacy and infusion services, reported financial results for the quarter ended June 30, 2019 (Press release, Diplomat Speciality Pharmacy, AUG 9, 2019, View Source [SID1234538545]). All comparisons, unless otherwise noted, are to the quarter ended June 30, 2018.

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

Second Quarter 2019 Highlights include:

Revenue of $1,288 million, compared to $1,416 million
Specialty segment revenue of $1,216 million, compared to $1,234 million
PBM segment revenue of $90 million, compared to $189 million
Specialty segment total prescriptions dispensed of 235,000, compared to 236,000
PBM segment total volume, adjusted to 30-day equivalent, of 942,000, compared to 2,123,000
Gross margin of 5.6% versus 6.9%
Specialty segment gross margin of 5.2% versus 5.9%
PBM segment gross margin of 10.7% versus 13.7%
EPS of $(2.13) per basic/diluted common share versus $(0.05) per basic/diluted common share
Adjusted EBITDA of $19.3 million, compared to $42.7 million
Adjusted EBITDA margin of 1.5% versus 3.0%
Net cash provided by operating activities was $43.1 million, compared to $18.1 million
Net debt1 decreased to $584.8 million, from $622.5 million at March 31, 2019.
Brian Griffin, Chairman and CEO of Diplomat, commented "We continue to believe in our business model and long-term prospects and we remain encouraged by our pipeline for 2020, despite our reduced guidance for 2019. We are pleased that infusion therapies continue to demonstrate strength and we are taking actions to improve our core specialty pharmacy business, rebuild our PBM and enhance our financial flexibility. At the same time, our Board has concluded that a broad review of strategic alternatives is in the best interests of the Company and our shareholders. While this is taking place, we intend to maintain our focus on executing our strategic plan, improving our businesses and supporting our shareholders, patients and their providers, payers, as well as our manufacturer partners and our employees."

Second Quarter Financial Summary:

Revenue for the second quarter of 2019 was $1,288 million, compared to $1,416 million in the second quarter of 2018, a decrease of $128 million or 9%. Our Specialty segment revenue amounted to $1,216 million, compared to $1,234 million in the prior year quarter, while revenue from our PBM segment amounted to $90 million, compared to $189 million in the prior year quarter. The decrease in our Specialty segment was primarily driven by payor reimbursement compression and the conversion of brand name drugs to their generic equivalent. The decrease was partially offset by the benefit of manufacturer price increases and growth in infusion therapies. The decrease in our PBM segment was due to previously disclosed contract losses.

Gross profit in the second quarter of 2019 was $72.7 million and generated a 5.6% gross margin, compared to $98.4 million gross profit and a 6.9% gross margin in the second quarter of 2018. Gross profit from our Specialty segment was $63.0 million and generated a 5.2% gross margin, compared to $72.5 million and a 5.9% gross margin in the prior period. The gross margin decrease in our Specialty segment was primarily driven by payor reimbursement compression. Gross profit from our PBM segment was $9.7 million and generated a 10.7% gross margin, compared to $25.9 million and a 13.7% gross margin in the prior period. The gross margin decrease in our PBM segment was primarily driven by a $2.5 million non-recurring client rebate payment.

Selling, general and administrative expenses for the second quarter of 2019 were $80.8 million, a decrease of $9.8 million, compared to $90.6 million in the second quarter of 2018. This decrease was primarily driven by a $4.2 million decrease in amortization expense, largely due to the impairment of our PBM segment in the fourth quarter of 2018, a $3.0 million decrease in merger and acquisition related expenses, and a $2.7 million decrease in share-based compensation expense primarily due to the recognition of our CEO share based RSU grant in the prior year period. We also reduced our consulting and recruiting expenses. These reductions were partially offset by an increase in severance, insurance, and facility expenses.

Net loss for the second quarter of 2019 was $(159.5) million compared to $(4.0) million in the second quarter of 2018. This decrease was primarily driven by an $85 million non-cash impairment charge related to goodwill and definite-lived intangible assets associated with our Specialty segment, as well as a $56 million non-cash impairment charge related to goodwill and definite-lived intangible assets associated with our PBM segment both due to a reduced forecast. The forecast reduction in Diplomat Specialty Pharmacy ("DSP"), a reporting unit within our Specialty segment, is due to less favorable drug mix, continued reimbursement pressure, slower than anticipated volume growth from our payor team investment, and a delay in implementing our new operating system which is also delaying the anticipated efficiencies. The PBM segment forecast reduction is due to lower earned rebates due to drug mix, slightly lower rebate retention, and a more conservative outlook for growth. Adjusted EBITDA for the second quarter of 2019 was $19.3 million compared to $42.7 million in the second quarter of 2018, a decrease of $23.4 million.

Loss per share for the second quarter of 2019 was $(2.13) per basic/diluted common share, compared to $(0.05) per basic/diluted common share for the second quarter of 2018.

2019 Financial Outlook

For the full-year 2019, we are updating our previous financial guidance:

Revenue between $4.7 and $5.0 billion
Specialty segment revenue between $4.4 and $4.6 billion
PBM segment revenue between $0.325 and $0.375 billion
Net loss between $(201) and $(191) million, versus the previous range of $(49) and $(33) million
Adjusted EBITDA between $87 and $93 million, versus the previous range of $110 and $116 million
Diluted EPS between $(2.69) and $(2.55), versus the previous range of $(0.65) and $(0.44)
Our income tax expectation for the year is an expense range of $1.5 to $2.0 million, primarily related to state taxes. A federal tax benefit will not be recorded for our 2019 losses as we are required to record a valuation allowance against any such benefit due to being in a cumulative loss position. Our EPS expectations for 2019 assume approximately 74,750,000 weighted average common shares outstanding on a diluted basis, versus the prior expectation of approximately 75,300,000, which could differ materially.

We have recently agreed with our lenders to amend certain financial performance covenants applicable to our credit facility. Amended terms became effective August 6, 2019 and amend the Total Net Leverage Ratio and Interest Coverage Ratio for the periods from the third quarter of 2019 through the fourth quarter of 2020, which is expected to provide the Company financial flexibility. As of March 31, 2021, the covenants revert back to the levels indicated in the original credit facility. Additional details are available in our Current Report on Form 8-K filed with the Securities and Exchange Commission on August 9, 2019.

Earnings Conference Call Information

As previously announced, the Company will hold a conference call to discuss its second quarter performance this morning, August 9, 2019, at 8:30 a.m. Eastern Time. Shareholders and interested participants may listen to a live broadcast of the conference call by dialing 833.286.5805 (647.689.4450 for international callers) and referencing participant code 7394702 approximately 15 minutes prior to the call. A live webcast of the conference call and associated slide presentation will be available on the investor relations section of the Company’s website for approximately 90 days at ir.diplomat.is.