On November 12, 2019 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported financial results for the three- and nine-month periods ended September 30, 2019 (Press release, Eagle Pharmaceuticals, NOV 12, 2019, View Source [SID1234551001]). Third quarter and recent highlights include:

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Invested $12 million in research and development and external legal costs to advance Eagle’s pipeline.
Eagle’s Japanese marketing partner, SymBio Pharmaceuticals Limited, submitted a New Drug Application ("NDA") for TREAKISYM, bendamustine ready-to-dilute liquid formulation, in Japan in September. Approval is expected in Q4 2020, which would trigger a $5 million milestone payment to Eagle. Potential payments to Eagle could reach $10 to $25 million per year in royalties and milestones.
Advanced clinical development plans for Eagle’s innovative fulvestrant program, which has the potential to change the treatment of estrogen receptor-positive breast cancer. The program aims to determine if the unique properties of Eagle’s product will result in greater inhibition of estrogen receptors and better patient outcomes compared to currently available treatment options. The Company expects to dose the first subject in December.
Enrolled additional patients in its controlled clinical study of RYANODEX (dantrolene sodium for injectable suspension) for the treatment of exertional heat stroke ("EHS") patients during the 2019 Hajj pilgrimage held from August 9-14 in Saudi Arabia. The Company has recruited a total of 41 patients at the 2015, 2018 and 2019 Hajj pilgrimages. Eagle has submitted a plan to the U.S. Food and Drug Administration ("FDA") that proposes reviewing the data collectively for all 41 patients. If FDA agrees with this plan, Eagle plans to resubmit the NDA for EHS in response to the Complete Response Letter received in 2017.
The Company, in dialogue with FDA, has received further clarity regarding RYANODEX for the treatment of brain damage secondary to nerve agent exposure. FDA has recommended that, under the animal rule, an additional study be conducted in a second species. Eagle expects to file a supplement to the current NDA in the second half of 2020.
Total revenue for Q3 2019 was $41.1 million, compared to $51.3 million in Q3 2018, primarily reflecting lower BENDEKA royalty revenue and lower product sales of BELRAPZO and RYANODEX, partially offset by higher product sales of BENDEKA.
Q3 2019 net loss was $2.4 million, or $0.17 per basic and diluted share, compared to net income of $14.0 million, or $0.94 per basic and $0.91 per diluted share in Q3 2018.
Q3 2019 adjusted non-GAAP net income was $3.7 million, or $0.27 per basic and $0.26 per diluted share, compared to adjusted non-GAAP net income of $18.3 million, or $1.22 per basic and $1.18 per diluted share, in Q3 2018.
Cash and cash equivalents were $117.2 million, net accounts receivable was $44.8 million, and debt was $40.0 million as of September 30, 2019.
"In the third quarter, we invested over $12 million to further advance our pipeline. This includes $9 million in non-GAAP R&D expense as well as $3 million in external legal expense related to the pemetrexed and vasopressin litigations. We are advancing our pipeline, as evidenced by the news today on EHS, nerve agent and the planned initiation of our next clinical trial for fulvestrant. We are also pleased that our bendamustine program is expanding to Japan, and we are expecting $10-$25 million in annual royalty and milestone payments beginning in 2021. This is an exciting time for Eagle as we move closer to realizing the full potential of many of our late-stage products," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

Third Quarter 2019 Financial Results

Total revenue for the three months ended September 30, 2019 was $41.1 million, as compared to $51.3 million for the three months ended September 30, 2018.

Royalty revenue was $26.5 million in the third quarter of 2019, compared to $35.2 million in the third quarter of 2018. BENDEKA royalties were $26.2 million in the third quarter of 2019, compared to $33.8 million in the third quarter of 2018. A summary of total revenue is outlined below:

Gross Margin was 64% during the third quarter of 2019, as compared to 75% in the third quarter of 2018. The compression in gross margin in the third quarter of 2019 was primarily driven by an increase in BENDEKA product sales to our marketing partner, on which Eagle earns no profit, and the decrease in BENDEKA royalty revenue.

R&D expense was $10.2 million for the third quarter of 2019, compared to $6.0 million in the third quarter of 2018. The increase is largely attributable to spending on fulvestrant and vasopressin. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense during the third quarter of 2019 was $9.0 million.

SG&A expense in the third quarter of 2019 increased to $18.5 million compared to $13.9 million in the third quarter of 2018. External legal spend associated with litigation on pemetrexed and vasopressin as well as higher stock compensation expense account for the year-over-year increase. Excluding stock-based compensation and other non-cash and non-recurring items, third quarter 2019 SG&A expense was $13.4 million.

Net loss for the third quarter of 2019 was $2.4 million, or $0.17 per basic and diluted share, compared to net income of $14.0 million, or $0.94 per basic and $0.91 per diluted share, in the third quarter of 2018, due to the factors discussed above.

Adjusted non-GAAP net income for the third quarter of 2019 was $3.7 million, or $0.27 per basic and $0.26 per diluted share, compared to adjusted non-GAAP net income of $18.3 million or $1.22 per basic and $1.18 per diluted share in the third quarter of 2018. 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 September 30, 2019, the Company had $117.2 million in cash and cash equivalents plus $44.8 million in net accounts receivable, $34.4 million of which was due from Teva Pharmaceutical Industries Ltd. The Company had $40.0 million in outstanding debt. Therefore, at September 30, 2019, the Company had net cash plus receivables of $122.0 million.

Conference Call

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

Date

Tuesday, November 12, 2019

Time

8:30 A.M. EST

Toll free (U.S.)

866-342-8591

International

203-518-9713

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 800-839-4577 (US) or 402-220-2682 (International) and entering conference call ID EGRXQ319. The webcast will be archived for 30 days at the aforementioned URL.

On November 12, 2019 Alkermes plc (Nasdaq: ALKS) reported that its corporate presentation will be webcast live at the Stifel 2019 Healthcare Conference on Tuesday, Nov. 19, 2019 at 1:15 p.m. ET (6:15 p.m. GMT) from New York (Press release, Alkermes, NOV 12, 2019, View Source [SID1234551017]). In addition, Alkermes’ corporate presentation will be webcast live at the Jefferies London Healthcare Conference on Thursday, Nov. 21, 2019 at 4:00 p.m. GMT (11:00 a.m. ET) from London, U.K. These presentations may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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On November 12, 2019 Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage biotechnology company developing transformational treatments for patients with non-alcoholic steatohepatitis (NASH) and other serious metabolic disorders, reported third quarter 2019 financial results for the period ending September 30, 2019 (Press release, Akers Bioscience (ABI), NOV 12, 2019, View Source [SID1234551032]).

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"The third quarter of 2019 was a period of continued clinical and manufacturing progress for Akero," said Andrew Cheng, M.D., Ph.D., President and Chief Executive Officer. "We remain on track to report results of the BALANCED study’s primary endpoint in the first quarter of 2020 and full study results in the second quarter of 2020. We have successfully completed laboratory-scale transfer of AKR-001 drug substance manufacturing to Boehringer Ingelheim with yield and biological activity comparable to the drug substance originally manufactured by Amgen. We expect to release drug product produced in compliance with current good manufacturing practice requirements and to complete all nonclinical toxicology studies required to support a Phase 2b trial by the fourth quarter of 2020. These actions – and our $147.8 million cash position – provide a strong foundation for the continued development of AKR-001, which we believe has the potential to become a cornerstone of NASH treatment."

Third Quarter 2019 Financial Results

Akero’s cash and cash equivalents at September 30, 2019 were $147.8 million.
Research and development expenses for the three-month and nine-month periods ended September 30, 2019 were $13.9 million and $23.9 million, respectively, compared to $1.2 million and $9.9 million for the comparable periods in 2018. These increases are attributable to higher costs related to Akero’s AKR-001 program, including third-party contract manufacturing, contract research organization costs associated with the BALANCED study and internal personnel costs.
General and administrative expenses for the three-month and nine-month periods ended September 30, 2019 were $2.4 million and $5.5 million, respectively, compared to $0.5 million and $0.9 million for the comparable periods in 2018. These increases are attributable to higher expenses for personnel, including non-cash stock-based compensation, and professional services and other costs associated with becoming a public company.
Total operating expenses were $16.3 million and $29.4 million for the three-month and nine-month periods ended September 30, 2019, respectively, compared to $1.7 million and $10.8 million for the comparable periods in 2018.
About NASH

NASH is a leading cause of liver failure around the world, driven by the growing global epidemic of obesity. NASH is a severe form of non-alcoholic fatty liver disease (NAFLD) characterized by liver cell (hepatocyte) damage, liver inflammation, and fibrosis that can progress to cirrhosis, liver failure, cancer and death.

About AKR-001

AKR-001 is an engineered human Fc-FGF21 fusion protein designed to harness the inherent benefits of an endogenous hormone called FGF21, with the potential to reduce liver fat, mitigate inflammation, and reverse fibrosis in NASH patients. AKR-001 is uniquely designed to deliver sustained signaling through FGF21’s receptors with once-weekly subcutaneous dosing.

On November 12, 2019 MilliporeSigma reported that it has signed a license agreement providing Evotec SE access to MilliporeSigma’s foundational CRISPR intellectual property (Press release, MilliporeSigma, NOV 12, 2019, View Source [SID1234551108]). Evotec, an international biotechnology company headquartered in Hamburg, Germany, will use MilliporeSigma’s CRISPR genome-editing technology to create edited cell lines for Evotec’s commercial and internal research purposes.

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MilliporeSigma’s CRISPR license to Evotec is the impetus for important drug testing and discovery, which will accelerate research and lead to new therapy development
MilliporeSigma’s CRISPR license to Evotec is the impetus for important drug testing and discovery, which will accelerate research and lead to new therapy development
"This CRISPR license is the impetus for important drug testing and discovery that promises to accelerate research and lead to the development of new therapies," said Udit Batra, CEO, MilliporeSigma. "MilliporeSigma has been at the forefront of innovation in gene editing for 15 years and continues to work with industry and academia to solve complex problems using our patented CRISPR technology, both ethically and responsibly."

Evotec plans to use MilliporeSigma’s CRISPR Intellectual Property Portfolio to develop precisely engineered assays to determine the biology and toxicity for potential drug candidates during the drug development cycle.

"Evotec is excited to continue its strong partnership with MilliporeSigma through licensing their groundbreaking CRISPR technology," said Craig Johnstone, Chief Operating Officer of Evotec. "Our vision and passion for innovation includes using CRISPR technology to test and improve the translation of efficacy of the new drugs we develop to bring relief to patients suffering from underserved conditions worldwide."

This new license reinforces past collaborations between MilliporeSigma and Evotec. In November 2016, the companies entered into a set of agreements whereby Evotec would provide screening services using MilliporeSigma’s collection of genetic reagents including CRISPR and shRNA libraries. Combining access to MilliporeSigma’s genome editing libraries with Evotec’s screening expertise offers a faster path to explore and identify new drug targets.

MilliporeSigma holds 20 CRISPR-related patents worldwide in methods and composition, including the fundamental technology of CRISPR Cas9 for genetic integration in mammalian cells.

As a supplier of genome-editing technology, MilliporeSigma supports research with genome editing under careful consideration of ethical and legal standards. MilliporeSigma’s parent company, Merck KGaA, Darmstadt, Germany has established an independent, external Bioethics Advisory Panel to provide guidance for research in which its businesses are involved, including research on or using genome editing. The company has also defined a clear operational position considering scientific and societal issues to inform promising therapeutic approaches for use in research and applications.

Follow MilliporeSigma on Twitter @MilliporeSigma, on Facebook @MilliporeSigma and on LinkedIn.

All Merck KGaA, Darmstadt, Germany news releases are distributed by email at the same time they become available on the EMD Group website. In case you are a resident of the U.S. or Canada please go to www.emdgroup.com/subscribe to register again for your online subscription of this service as our newly introduced geo-targeting requires new links in the email. You may later change your selection or discontinue this service.

About the Life Science Business of Merck KGaA, Darmstadt, Germany
The Life Science business of Merck KGaA, Darmstadt, Germany, which operates as MilliporeSigma in the U.S. and Canada, has some 21,000 employees and 59 manufacturing sites worldwide, with a portfolio of more than 300,000 products focused on scientific discovery, biomanufacturing and testing services. Udit Batra is the global chief executive officer of MilliporeSigma.

Merck KGaA, Darmstadt, Germany completed its $17 billion acquisition of Sigma-Aldrich in November 2015, creating a leader in the $125 billion global life science industry.

Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and performance materials. Around 56,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From advancing gene-editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2018, Merck KGaA, Darmstadt, Germany generated sales of €14.8 billion in 66 countries.

The company holds the global rights to the name and trademark "Merck" internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials. Since its founding 1668, scientific exploration and responsible entrepreneurship have been key to the company’s technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company. For more information about Merck, KGaA, Darmstadt, Germany, visit www.emdgroup.com.

On November 12, 2019 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, reported that the FDA has approved a request for Investigational New Drug ("IND") status for its drug candidate WP1066 to be used in a Phase 1 clinical trial for the treatment of children with recurrent or refractory malignant brain tumors (Press release, Moleculin, NOV 12, 2019, View Source [SID1234550933]). The request was made by physician researchers at Emory University, including Dr. Tobey MacDonald, Professor of the Department of Pediatrics at Emory University School of Medicine, Director of Pediatric Neuro-Oncology at Aflac Cancer and Blood Disorders Center and Principle Investigator for this clinical trial. The trial will be conducted at the Aflac Cancer and Blood Disorders Center at Children’s Healthcare of Atlanta.

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Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)

"This FDA approval gives a green light for Emory University to begin an important clinical trial to explore a new approach to treating pediatric brain cancer," commented Walter Klemp, Moleculin’s Chairman and CEO. "WP1066 is currently in a clinical trial for adult patients with glioblastoma and melanoma metastases to the brain at MD Anderson Cancer Center, and this is a logical extension of that research. WP1066 is an inhibitor of the activated form of a protein called STAT3, a target that has been implicated in a wide range of highly resistant cancers. Preclinical research at Emory University indicated that WP1066 had a significant anti-tumor effect on medulloblastoma cell lines, so there is a lot of encouragement regarding the opportunity to provide new hope for treating this rare condition."