On May 15, 2018 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to the development and delivery of high quality, cost-effective pharmaceutical products and innovative therapeutics to patients in the U.S., China and throughout the world, reported financial results for the first quarter and provided a review of recent accomplishments and anticipated upcoming milestones (Press release, CASI Pharmaceuticals, MAY 15, 2018, View Source [SID1234526614]).
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Ken K. Ren, Ph.D., CASI’s Chief Executive Officer, commented, "We have made significant progress in 2018, having acquired a portfolio of 25 US FDA-approved ANDAs from Sandoz, which has substantially broadened our product pipeline. The acquisition squarely enhances our strategic focus of capitalizing on the evolving CFDA landscape, which is expected to streamline and accelerate the approval process for high-quality generic products."
Dr. Ren continued, "The capital raise announced in March leaves us well-positioned to drive forward with our EVOMELA commercialization plans, and given the positive tenor of the April 2018 Center for Drug Evaluation (CDE) Expert Advisory Committee meeting, where no questions were posed and no new materials were requested, we remain encouraged that we will receive additional feedback from the CDE/CFDA regarding the EVOMELA application in the coming weeks. We remain committed to developing a strong and robust product portfolio through licensing opportunities as well as seeking other advantageous relationships that will further expand our footprint in both the U.S. and in China."
CASI Pharmaceuticals, Inc. / 9620 Medical Center Drive / Suite 300 / Rockville, MD 20850
Phone 240.864.2600 / Fax 301.315.2437
First Quarter and Recent Business Highlights
Company prepares for commercial launch of EVOMELA in China – In March 2018, CASI hired Thomas Zhang as General Manager of its Sales & Marketing team in China and is currently building out a robust and experienced team in China to support commercial operations there. Mr. Zhang has over 20 years of commercial experience in China, and prior to joining CASI was responsible for the successful launch and commercialization of Herceptin and Xeloda at Shanghai Roche Pharmaceuticals Co., Ltd. A team of seasoned sales and marketing professionals are being hired in preparation for the launch of EVOMELA following anticipated marketing authorization.
Update on advisory committee meeting notice from China Center for Drug Evaluation (CDE) – On April 26, 2018, the Center for Drug Evaluation (CDE), a group within the China FDA in charge of technical review, held a meeting of the Expert Advisory Anti-Tumor (Oncology) Drugs Committee (the "Advisory Committee") to review the EVOMELA application. In preparation for the Advisory Committee meeting, no additional questions were posed and the CDE requested no new analysis or materials. The Advisory Committee meeting did not include sponsor or public participants and the Advisory Committee will provide its recommendations directly to the CDE. CASI anticipates receiving feedback from the CDE/CFDA on the EVOMELA application in the coming weeks.
Acquired portfolio of 25 US FDA-approved ANDAs from Sandoz Inc. – In January 2018, the Company announced the acquisition of a portfolio of 25 US FDA-approved ANDAs, plus four pipeline ANDA’s that are pending FDA approval. CASI intends to select and commercialize certain products from the portfolio that have a unique market opportunity and cost-effective manufacturing in China and/or in the U.S.
Announced $50 million private placement to new and existing investors – In March 2018, the Company announced a $50 million private placement (common stock with accompanying warrants). Existing stockholders or their affiliates, including IDG-Accel China Growth Fund III, ETP Global Fund LP, and new stockholders including Robert W. Duggan, former Chairman and CEO of Pharmacyclics Inc., led the financing.
Upcoming presentations – CASI will provide a corporate update at the 2018 BIO International Convention (Boston, MA June 4-7).
Financial Results for the Quarter ended March 31, 2018
Cash Position: As of March 31, 2018, CASI had cash and cash equivalents of $49.9 million.
R&D Expenses: R&D expenses for the quarter ended March 31, 2018 were $1.7 million compared to $1.0 million in 2017, an increase of $0.7 million. The increase in R&D expenses primarily reflects costs associated with the technology transfer activities and regulatory support associated with the recently acquired ANDA portfolio, including non-cash intangible amortization expense of $0.3 million.
G&A Expenses: G&A expenses for the quarter ended March 31, 2018 were $1.3 million compared to $0.6 million in 2017. The increase in G&A over the prior year is primarily attributed to an increase in salary, benefits and recruitment expense in China, largely related to sales and marketing efforts to prepare for the anticipated launch of the Company’s first commercial product in China, as well as other general and administrative functions. There were also increased costs associated with business development, investor and public relations activities, and an increase in legal and other professional services fees during the 2018 period.
Net Loss: The Company reported a net loss of ($3.6 million), or ($0.05) per share, for the quarter ended March 31, 2018. This compares with a net loss of ($1.7 million), or ($0.03) per share for the first quarter of 2017. The increase in net loss is primarily due to costs associated the technology transfer activities and regulatory support for our ANDA portfolio, the write-off of approximately $0.7 million due to acquired in-process R&D primarily related to ANDAs not approved by the FDA, and increased costs associated with G&A functions, including employment costs for sales and marketing efforts, increased business development and investor relations activities, as well as other professional service fees.