On May 7, 2019 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that the Company will release its first quarter financial results on Tuesday, May 14, 2019, after the close of US markets (Press release, Curis, MAY 7, 2019, View Source [SID1234535822]). Management will host a conference call on the same day at 4:30 p.m. ET.

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To access the live conference call, please dial (888) 346-6389 from the United States or (412) 317-5252 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed on the Curis website at www.curis.com in the ‘Investors’ section. A replay of the financial results conference call will be available on the Curis website shortly after completion of the call.

On May 7, 2019 Takeda Pharmaceutical Company Limited [TSE: 4502 / NYSE: TAK] reported that it will present a total of five company-sponsored poster presentations, as well as an oral pipeline symposium, at the 15th International Symposium on Myelodysplastic Syndromes taking place in Copenhagen, Denmark from May 8-11, 2019 (Press release, Takeda, MAY 7, 2019, View Source [SID1234535855]). Takeda’s presentations will highlight the company’s investigations into the epidemiology, prognosis and patient reported outcomes for higher-risk myelodysplastic syndromes (HR-MDS) and the related conditions – chronic myelomonocytic leukemia (CMML) and acute myeloid leukemia (AML) – to achieve a deep understanding of these rare cancers and the needs of this patient community.

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"We are excited to join the MDS community at this upcoming meeting where we will share key findings around Takeda’s research in HR-MDS, CMML and AML," said Hui Huang, PhD, Head, Oncology Global Outcomes Research at Takeda. "For over a decade, there has been little advancement in treatment options for people living with HR-MDS and CMML, despite poor patient outcomes. Takeda’s investment in this wide-ranging global outcomes research directly captures patient input to better understand these cancers, as well as AML, and the impact on their lives. These findings are an important aspect of our work as we strive to bring new treatment options to patients."

At this year’s International Symposium on Myelodysplastic Syndromes, Takeda will present results from a variety of innovative research studies. These results are the first global systematic review of HR-MDS and CMML on incidence and prevalence, including the risk of transformation to AML. The results will also quantify the disease burden, discuss the difficulties associated with diagnosis and underscore the significant unmet need of this patient population. Some of this research was conducted in collaboration with the MDS Foundation – an international non-profit advocacy organization whose mission is to support and educate patients and healthcare providers with innovative research into the fields of MDS, AML and related myeloid neoplasms.

Five Takeda Oncology-sponsored abstracts were accepted for poster presentation, as well as an oral pipeline symposium during MDS 2019:

Note: All times listed are in Central European Standard Time

Understanding and Measuring Fatigue In Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, and Acute Myeloid Leukemia: Mixed Method Research. Abstract MDS19-0051. Wednesday, May 8, 1:00 p.m. – 9:30 p.m. (Tivoli Conference Center, Room Vandsalen).
Epidemiology of Chronic Myelomonocytic Leukemia: A Systematic Review. Abstract MDS19-0038. Wednesday, May 8, 1:00 p.m. – 9:30 p.m. (Tivoli Conference Center, Room Vandsalen).
Is Contemporary Incidence Estimation of Higher-Risk Myelodysplastic Syndrome Possible? Results From a Systematic Literature Review. Abstract MDS19-0037. Wednesday, May 8, 1:00 p.m. – 9:30 p.m. (Tivoli Conference Center, Room Vandsalen).
Identification of the Most Suitable Patient-Reported Outcomes Measure for Trials in Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, and Acute Myeloid Leukemia. Abstract MDS19-0052. Wednesday, May 8, 1:00 p.m. – 9:30 p.m. (Tivoli Conference Center, Room Vandsalen).
Characteristics of Untreated Patients with Higher-Risk Myelodysplastic Syndromes (HR-MDS) Identified in a United States (US) Electronic Medical Record (EMR) Database. Abstract MDS19-0035. Wednesday, May 8, 1:00 p.m. – 9:30 p.m. (Tivoli Conference Center, Room Vandsalen).
A Pragmatic Patient-Reported Outcome Strategy for Rare Disease Clinical Trials: Application of the EORTC Item Library. Oral Symposium Presentation. Thursday, May 9, 11:45 a.m. – 12:45 p.m. (Tivoli Congress Hall).
For more information, the MDS 2019 program is available here: View Source

About Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia and Acute Myeloid Leukemia

Myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) and acute myeloid leukemia (AML) are rare forms of blood cancer that are caused by irregular blood cell production within the bone marrow. As a result of this irregular production, a person with MDS, CMML or AML does not have enough normal red blood cells, white blood cells and/or platelets in circulation. Symptoms for MDS, CMML and AML are often vague and related to low blood counts, and may include fatigue, shortness of breath, easy bruising or bleeding, loss of appetite, weakness, pale skin, fever and frequent or severe infections.

There are several classifications of MDS – lower risk to higher-risk – determined by blood counts, blast counts, mutations and cytogenetics. Higher-risk disease is defined as intermediate, high or very high risk on the International Prognostic Scoring System – Revised (IPSS-R), and these patients often have a poorer prognosis. In some cases, MDS and CMML can progress into AML.

On May 7, 2019 Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported financial results for the first quarter of 2019 and associated Company developments (Press release, Supernus, MAY 7, 2019, View Source [SID1234535883]).

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Commercial Update

First quarter 2019 product prescriptions for Trokendi XR and Oxtellar XR, as reported by IQVIA, totaled 199,520, an 11.0% increase over the first quarter of 2018.

In the fourth quarter of 2018, wholesalers, distributors, and pharmacies increased their inventory holdings as compared to the prevailing inventory levels in the third quarter of 2018. As previously disclosed, the Company estimated that this caused net product sales to be approximately $10 million higher in the fourth quarter of 2018 than it would have been otherwise, had inventory levels remained consistent quarter to quarter.

This process was effectively reversed in the first quarter of 2019, with net product sales decreasing in the first quarter of 2019 by an estimated $10 million, as compared both to the prior year as well as the prior quarter.

In addition, net product sales were impacted by the growing prevalence of high deductible patient plans, their seasonal effect on first quarter prescription trends, and the seasonal increase in our use of copay assistance. Consequently, gross to net deductions were higher by approximately $4 million, as compared to the first quarter of 2018.

Progress of Product Pipeline

During its Investor Day held on April 16, 2019, the Company provided a product pipeline update as set forth below.

SPN-812 – Novel non-stimulant for the treatment of ADHD

During March 2019, the Company announced data from the fourth and final Phase III study for SPN-812 (P304) that confirm positive results from the previous three Phase III studies on SPN-812, announced in December 2018.
The Company continues to expect to submit a New Drug Application (NDA) for SPN-812 in the second half of 2019, and to launch it, pending U.S. Food and Drug Administration (FDA) approval, in the second half of 2020.
A Phase III program in adult patients is anticipated to start in the second half of 2019.
SPN-810 – Novel treatment of Impulsive Aggression in patients with ADHD

Enrollment in the Phase III trials (P301 and P302) continues with data from both trials expected in the second half of 2019.
The Company continues to expect to submit an NDA for SPN-810 in the second half of 2020, and to launch it, pending FDA approval, in the second half of 2021.
Enrollment in the open label extension (OLE) study continues at 90% or higher. On average, a patient in the OLE study remains on SPN-810 treatment for approximately 10.5 months, which the Company believes is an encouraging sign of the tolerability and efficacy of SPN-810.
Patient dosing continues in the Phase III trial (P503) in adolescent patients.
SPN-604 – Novel treatment of bipolar disorder

The Company expects to start a pivotal Phase III program for the treatment of bipolar disorder in the fourth quarter of 2019.
Operating Expenses

Research and development expenses in the first quarter of 2019 were $15.4 million, as compared to $18.9 million in the same quarter last year. This decrease is due to the completion of the four Phase III clinical trials for SPN-812, three of which were completed in December 2018 and one completed in March 2019. The decrease was partially offset by the manufacture of validation and registration lots for SPN-812 to support the Company’s upcoming submission of its New Drug Application (NDA).

Selling, general and administrative expenses in the first quarter of 2019 were $41.0 million, as compared to $36.8 million in the same quarter last year. This increase was primarily due to the development and production of promotional materials and marketing programs associated with the launch of the monotherapy indication for Oxtellar XR.

Operating Earnings and Earnings Per Share

Operating earnings in the first quarter of 2019 were $25.4 million, compared to $31.4 million in the same quarter last year. The decrease in operating earnings was primarily due to decreased net product sales. Excluding the negative impact to net product sales from the aforementioned inventory drawdown in the first quarter, operating earnings would have been approximately $9.5 million higher than in 2018.

Net earnings (GAAP) in the first quarter of 2019 were $18.3 million, or $0.34 per diluted share, compared to $26.4 million, or $0.49 per diluted share, in the same period last year. In addition to the impact of lower operating earnings for the first quarter of 2019, net earnings (GAAP) were subject to a higher effective tax rate in the first quarter of 2019 relative to the first quarter of 2018. The tax rate in the first quarter of 2018 benefited from stock option exercises.

Weighted-average diluted common shares outstanding were approximately 54.0 million in the first quarter of 2019, as compared to approximately 53.8 million in the prior year period.

"Our financial results for the first quarter were adversely impacted by several factors, converging all at once: the fourth quarter 2018 inventory buildup impacting shipments in first quarter 2019: first quarter seasonal insurance plan dynamics putting pressure on prescription growth coupled with increased gross-to-net deductions through our copay assistance; and the increase in the effective tax rate compared to same period in 2018," said Jack Khattar, President and CEO of Supernus. "Aside from the effective tax rate, these one-time events are not expected to have a continuing effect in the subsequent quarters. We have already seen in the second quarter of 2019 a normalization of shipments and prescription trends"

Balance Sheet Highlights

As of March 31, 2019, the Company had $815.5 million in cash, cash equivalents, marketable securities, and long term marketable securities, compared to $774.8 million at December 31, 2018. This increase primarily reflects cash generated from operations in the first quarter of 2019.

Financial Guidance

For full year 2019, the Company reiterates its prior guidance for net product sales, research and development expenses, operating earnings, and effective tax rate as set forth below:

Net product sales in the range of $435 million to $455 million
Research and development expenses in the range of $70 million to $80 million
Operating earnings in the range of $160 million to $180 million
Effective tax rate of approximately 23% to 25%
Conference Call Details

The Company will hold a conference call hosted by Jack Khattar, President and Chief Executive Officer, and Greg Patrick, Senior Vice President and Chief Financial Officer, to discuss these results at 9:00 a.m. Eastern Time, on Wednesday, May 8, 2019. An accompanying webcast also will be provided.

Please refer to the information below for conference call dial-in information and webcast registration. Callers should dial in approximately 10 minutes prior to the start of the call.

Conference dial-in: (877) 288-1043
International dial-in: (970) 315-0267
Conference ID: 8139879
Conference Call Name: Supernus Pharmaceuticals First Quarter 2019 Earnings Conference Call
Following the live call, a replay will be available on the Company’s website, www.supernus.com, under "Investor Relations".

On May 7, 2019 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (Nasdaq: EGRX) reported its financial results for the three months ended March 31, 2019 (Press release, Eagle Pharmaceuticals, MAY 7, 2019, View Source [SID1234535799]). Highlights of, and subsequent to, the first quarter of 2019 include:

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Business and Recent Highlights:

·Completed a successful study to evaluate the neuroprotective effects of RYANODEX (dantrolene sodium) for the treatment of nerve agent exposure:

· Conducted in collaboration with the United States Army Medical Research Institute of Chemical Defense (USAMRICD), the nation’s leading science and technology laboratory in the area of medical chemical countermeasures research and development;

· The Company plans to meet with the U.S. Food and Drug Administration (FDA) as soon as possible;

·Announced a revised licensing agreement for BENDEKA that extends the term of the agreement until the product is no longer sold and increases Eagle’s royalty rate from 25% to 30% in October 2019 and by 1% annually until it reaches 32%;

· The FDA issued a decision in favor of Eagle regarding the scope of BENDEKA’s Orphan Drug Exclusivity (ODE), further protecting the longevity of the BENDEKA franchise; and

·The Centers for Medicare and Medicaid Services (CMS) established a unique, product specific, billing code (J-code: J9036) effective July 1, 2019, for BELRAPZO, the brand name under which Eagle’s currently marketed 500mL infusion bendamustine solution will be sold beginning June 3, 2019.

Financial Highlights:

· Total revenue for the first quarter of 2019 was $49.8 million, compared to $46.6 million in the first quarter of 2018;

·Q1 2019 bendamustine hydrochloride 500ml solution ("Big Bag" or "BELRAPZO") product sales were $3.2 million;

·Q1 2019 RYANODEX product sales were $4.0 million, compared to $4.4 million in Q1 2018;

Eagle Pharmaceuticals Reports First Quarter 2019 Results

·Q1 2019 net income was $9.0 million, or $0.64 per basic and $0.62 per diluted share, compared to net income of $2.6 million, or $0.18 per basic and $0.17 per diluted share in Q1 2018;

Q1 2019 adjusted non-GAAP net income was $14.6 million, or $1.05 per basic and $1.01 per diluted share, compared to adjusted non-GAAP net income of $8.2 million, or $0.55 per basic and $0.53 per diluted share in Q1 2018; and

·Cash and cash equivalents were $102.1 million, net accounts receivable was $63.9 million, and debt was $42.5 million as of March 31, 2019.

"This is an exciting time at Eagle as we continue to position the Company for growth. We have solidified our bendamustine franchise by securing marketing exclusivity for BENDEKA and effectively preventing generic competition through the end of 2022, revising our licensing agreement for BENDEKA to extend the term of the agreement well beyond 2025 and increase our royalty rate, and launching BELRAPZO, our 500mL infusion bendamustine product, which will have its own unique J-code effective July 1st of this year. Combined, these efforts now give us the most certitude for our bendamustine portfolio since launch and should provide a very strong base of earnings upon which we can continue to build to further grow the Company," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

"With bendamustine as a solid base for many years to come, we are excited about our pipeline. Today’s news about RYANODEX for nerve agent exposure is an important step in diversifying our product line and building growth," concluded Tarriff.

First Quarter 2019 Financial Results

Total revenue for the three months ended March 31, 2019 was $49.8 million, as compared to $46.6 million for the three months ended March 31, 2018. We recorded $9.0 million in revenue during the first quarter of 2019 upon execution of an agreement to terminate Teva’s obligation to pay future milestones and royalties on BENDEKA sales outside of the U.S.

Royalty revenue was $26.3 million in the first quarter of 2019, compared to $35.8 million in the first quarter of 2018. BENDEKA royalties were $26.0 million in the first quarter of 2019, compared to $34.0 million in the first quarter of 2018. A summary of total revenue is outlined below:

Gross Margin was 74% during the first quarter of 2019, as compared to 75% in the first quarter of 2018.

R&D expenses were $6.4 million for the quarter, compared to $17.3 million in the same quarter in the prior year. The first quarter year over year decrease reflects a substantial reduction in fulvestrant expense, partially offset by the cost to bring vasopressin to market. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense during the first quarter was $5.2 million.

SG&A expenses in the first quarter of 2019 increased to $18.1 million compared to $15.2 million in the first quarter of 2018. External legal expenses associated with litigation on PEMFEXY, vasopressin and bendamustine and higher stock compensation expense account for the year over year increase. Excluding stock-based compensation and other non-cash and non-recurring items, first quarter 2019 SG&A expense was $12.9 million.

Net income for the first quarter of 2019 was $9.0 million, or $0.64 per basic and $0.62 per diluted share, compared to net income of $2.6 million, or $0.18 per basic and $0.17 per diluted share in the three months ended March 31, 2018, due to the factors discussed above.

Adjusted non-GAAP net income for the first quarter of 2019 was $14.6 million, or $1.05 per basic and $1.01 per diluted share, compared to Adjusted non-GAAP net income of $8.2 million or $0.55 per basic and $0.53 per diluted share in the prior year quarter. For a full reconciliation of adjusted non-GAAP net income to the most comparable GAAP financial measures, please see the tables at the end of this press release.

2019 Expense Guidance

· R&D spend in 2019, on a non-GAAP basis, is expected to be $32.0-$36.0 million, as compared to $38.0 million in 2018.

· SG&A spend in 2019, on a non-GAAP basis, is expected to be $51.0-$54.0 million, as compared to $43.0 million in 2018.

The guidance provided in this section represents forward-looking information, and actual results may vary. Please see the risks and assumptions referred to in the Forward-Looking Statements section of this press release.

Liquidity

As of March 31, 2019, the Company had $102.1 million in cash and cash equivalents and $63.9 million in net accounts receivable, $46.6 million of which was due from Teva Pharmaceutical Industries Ltd. The Company had $42.5 million in outstanding debt. Therefore, at March 31, 2019, the Company had net cash and receivables of $123.6 million.

Conference Call

As previously announced, Eagle management will host its first quarter 2019 conference call as follows:

Date

Tuesday, May 7, 2019

Time

8:30 A.M. EDT

3

Toll free (U.S.)

877-876-9176

International

785-424-1670

Webcast (live and replay)

www.eagleus.com, under the "Investor + News" section

A replay of the conference call will be available for one week after the call’s completion by dialing 800-839-5493 (US) or 402-220-2552 (International) and entering conference call ID EGRXQ119. The webcast will be archived for 30 days at the aforementioned URL.

On May 7, 2019 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on our Probody therapeutic technology platform, reported that the company will present at the Bank of America Merrill Lynch 2019 Health Care Conference (Press release, CytomX Therapeutics, MAY 7, 2019, View Source [SID1234535823]). Sean McCarthy, D.Phil., president, chief executive officer and chairman, will deliver a corporate overview on May 16, 2019, at 10:15 a.m. PDT/ 1:15 p.m. EDT.

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A live audio webcast of the presentation will be available through the Investors and News section of CytomX’s website. An archived replay will be available for 90 days following the event.