Avid Bioservices Reports Financial Results for First Quarter Fiscal 2020 and Recent Developments

On September 5, 2019 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, reported financial results for the first quarter of fiscal 2020 ended July 31, 2019 (Press release, Avid Bioservices, SEP 5, 2019, View Source [SID1234539300]).

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Highlights Since April 30, 2019

"During the first quarter of 2020, we recorded revenue that met our expectations for the period, significantly strengthened our backlog and initiated a number of operational improvements in our facilities," stated Rick Hancock, interim president and chief executive officer. "Despite our topline strength, margins declined during the quarter due to several factors, none of which are expected to impact our stated guidance for the year. These factors include an increase in headcount to accommodate growth in production demand, a realignment of the company’s compensation structure to secure our existing work force, and equipment repairs.

"Important achievements during the period included the completion of an additional process validation campaign for a customer that anticipates conducting future commercial manufacturing at Avid. The company also entered into two new contract manufacturing service agreements during the first quarter, adding one of the world’s leading pharmaceutical companies to our customer list. These projects are currently in the onboarding process, both of which are proceeding well.

"During the period, Avid also announced the appointment of Catherine Mackey, Ph.D. as an independent member to the company’s board of directors. With more than 30 years experience in biopharma research and development, Dr. Mackey brings an important perspective that will allow us to best support the needs of our current, as well as prospective clients. The board is thrilled with Dr. Mackey’s appointment and we look forward to working together toward Avid’s continued growth.

"The highlights of the first quarter of 2020 were new customer contracts, significant backlog growth and completion of another successful process validation campaign. We believe each of these accomplishments will contribute significantly to the future growth and expansion of the business and we are eager to build on this momentum."

Financial Highlights and Guidance

The company is reaffirming revenue guidance for the full fiscal year 2020 of $64 million – $67 million.

Revenue was $15.3 million for the first quarter of fiscal 2020, a 21% increase compared to $12.6 million for the first quarter of last fiscal year. This increase is primarily due to growing demand from a more diversified client base.

As of July 31, 2019, revenue backlog was approximately $61 million, an increase of 34% as compared to the fourth quarter of fiscal 2019. The company expects to recognize the majority of this backlog in fiscal year 2020.

Gross margin for the first quarter of fiscal 2020 of 7% was down slightly compared to a gross margin of 9% in the prior year period. Despite increased revenue during the first quarter of 2020, gross margin was impacted by hiring personnel to accommodate growth in production demand, a realignment of the company’s compensation structure to secure our existing work force, and equipment repairs that impacted efficiencies during the period. Management does not expect these factors to impact our stated revenue guidance for the year.

Selling, general and administrative expenses ("SG&A") for the first quarter of fiscal 2020 were $4.5 million compared to $3.2 million for the first quarter of last year. The increase in SG&A was primarily due to employee separation-related expenses, and increased stock-based compensation. Excluding the separation agreement expenses and the increase in stock-based compensation, SG&A during the first quarter of 2020 is consistent with SG&A for the prior year quarter.

For the first quarter of fiscal 2020, the company recorded consolidated net loss attributable to common stockholders of $4.6 million or $0.08 per share, compared to a consolidated net loss attributable to common stockholders of $3.4 million or $0.06 per share, for the first quarter of fiscal 2019.

Avid reported $28.9 million in cash and cash equivalents as of July 31, 2019, compared to $32.4 million on April 30, 2019.
More detailed financial information and analysis may be found in Avid Bioservices’ Quarterly Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today.

Recent Corporate Developments

Signed two new contract manufacturing service agreements to support the development of novel drug candidates. The agreements include the addition of one of the world’s leading pharmaceutical companies to Avid’s growing list of customers, as well as the expansion of the relationship with one of the company’s existing biotechnology customers.

Completed the first process validation campaign of fiscal 2020. Completion of a process validation campaign is a critical step in the regulatory product approval process, and is likely to result in future commercial production at Avid.

Appointed Catherine Mackey, Ph.D. as an independent member to the company’s board of directors. Dr. Mackey is an experienced leader, director and advisor with more than 30 years of R&D and operations experience in the pharmaceutical, biotechnology and agricultural industries, including over a decade in key leadership roles at Pfizer Inc.
Conference Call

Avid will host a conference call and webcast this afternoon, September 5, 2019, at 4:30 PM EDT (1:30 PM PDT).

To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Avid Bioservices conference call. To listen to the live webcast, or access the archived webcast, please visit: View Source

Merck to Present at the Morgan Stanley 17th Annual Global Healthcare Conference

On September 5, 2019 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that Kenneth C. Frazier, chairman and chief executive officer, and Dr. Roger M. Perlmutter, president, Merck Research Laboratories, are scheduled to present during a fireside chat at the Morgan Stanley 17th Annual Global Healthcare Conference in New York on Sept. 9, 2019 at 10:30 a.m. EDT (Press release, Merck & Co, SEP 5, 2019, View Source [SID1234539299]).

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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at https://cc.talkpoint.com/morg007/090919b_js/?entity=73_1XEFBTH.

Can-Fite to Present at H. C. Wainwright 21st Annual Global Investment Conference on September 10, 2019

On September 5, 2019 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that bind specifically to the A3 adenosine receptor (A3AR), addressing cancer, liver and inflammatory diseases, reported the Company’s CEO Dr. Pnina Fishman will present at the H. C. Wainwright 21st Annual Global Investment Conference to be held on September 8-10, 2019 at the Lotte New York Palace Hotel in New York City (Press release, Can-Fite BioPharma, SEP 5, 2019, https://ir.canfite.com/news/detail/864/can-fite-to-present-at-h-c-wainwright-21st-annual-global-investment-conference-on-september-10-2019 [SID1234539298]).

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Dr. Fishman will present on Tuesday, September 10th at 3:00 p.m. in the Kennedy I room, 4th floor. Company executives will also conduct one-on-one meetings with institutional investors.

Selvita Reports Second Quarter and Half-year 2019 Financial Results

On September 5, 2019 Selvita (WSE: SLV) reported second quarter 2019 financial results and provided a corporate update (Press release, Selvita, SEP 5, 2019, View Source [SID1234539281]).

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"We continue to execute on the priorities we set out early in the year," commented Pawel Przewiezlikowski, Chief Executive Officer of Selvita. "We expect to see our oncology therapeutics and research services divisions operate as independent public companies in the fourth quarter of 2019, and our portfolio programs continue to advance as expected. Dosing of the first patient in our Phase 1 study of CDK8 inhibitor SEL120 is expected in the third quarter of 2019 and we expect to select an additional candidate to advance into clinical development by the end of 2019."

Recent Achievements

In June, a poster relating to the Phase 1/2 study of SEL24/MEN1703, an oral dual PIM/FLT3 kinase discovered by Selvita, was presented at the 24th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) (Abstract PF281).
In June, a poster relating to the Phase 1/2 study of SEL24/MEN1703 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Abstract TPS7062).
Selvita Oncology Second Quarter and Six Months Ended June 30, 2019 Financial Results

Operating loss (EBITDA excluding IFRS16 impact) for the quarter ended June 30, 2019, was $(2.7) million, compared to net loss of $(0.8) million for the quarter ended June 30, 2018. Revenues attributable to non-dilutive grant sources were $2.1 million for the quarter ended June 30, 2019, compared to grant revenues of $1.6 million for the quarter ended June 30, 2018. Research and development expenses were $5.0 million for the quarter ended June 30, 2019, an increase of $1.8 million, compared to $3.2 million for the same period ended June 30, 2018. The increase in research and development expenses was primarily attributable to the fact that the Group strongly focuses on the development of its own research projects and preparing them for commercialization at the later stages of development.

Operating loss (EBITDA excluding IFRS16 impact) for the six months ended June 30, 2019, was $(4.9) million, compared to net loss of $(1.4) million for the quarter ended June 30, 2018. Revenues attributable to non-dilutive grant sources were $4.1 million for the six months ended June 30, 2019, compared to grant revenues of $2.7 million for the six months ended June 30, 2018. Research and development expenses were $9.5 million for the six months ended June 30, 2019, an increase of $4.0 million, compared to $5.5 million for the same period ended June 30, 2018.

At June 30, 2019, Selvita Oncology held $20 million in cash, cash equivalents, and short-term investments.

Selvita CRO Second Quarter and Six Months Ended June 30, 2019 Financial Results

Research Services revenues for the quarter ended June 30, 2019, were $5.5 million, an increase of $1.3 million compared to revenues of $4.2 million for the quarter ended June 30, 2018. Operating profits (EBITDA excluding IFRS16 impact) in the Services Division were $1.2 million for the quarter ended June 30, 2019, as compared with $0.9 million for the same period ended June 30, 2018.

Research Services revenues for the six months ended June 30, 2019, were $10.4 million, an increase of $2.2 million compared to revenues of $8.2 million for the quarter ended June 30, 2018. Operating profits (EBITDA excluding IFRS16 impact) in the Services Division were $2.1 million for the quarter ended June 30, 2019, as compared with $1.8 million for the same period ended June 30, 2018.

Bexion Pharmaceuticals, Inc. To Present Clinical Data at 2019 NORD Annual Meeting

On September 4, 2019 Bexion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on rare brain and solid tumors, reported that it will feature a clinical poster presentation at the National Organization for Rare Disorders’ (NORD) Rare Disease and Orphan Products Breakthrough Summit taking place October 21-22, 2019 in Washington, D.C. at the Marriott Wardman Park (Press release, Bexion, SEP 4, 2019, View Source [SID1234539354]).

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NORD Annual Meeting
The NORD Annual Meeting brings together approximately 1000 multi-stakeholders in the rare disease community including Senior FDA officials, advocacy/patient groups, bio/pharma and solution services professionals.

First-in-human, First-in-class
Bexion’s poster is entitled, "First-in-human, First-in-class Phase 1 Study of BXQ-350 for Solid Tumors and Gliomas," and includes updated clinical information from the original poster presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in June, 2018.

Strong Safety and Tolerability
"This Phase 1 study of BXQ-350 demonstrated a strong safety and tolerability profile for a first-in-class, novel approach to treating brain and solid tumors," said Ray Takigiku, CEO and President of Bexion. "We are also highly encouraged by the evidence of possible clinical activity in some of our patients and are excited to explore the potential of this compound in future clinical trials."