Benzinga | May 18, 2021 10:28AM EDT

BICX: BICX104 IND Approved

By Beth Senko, CFA

OTC:BICX

READ THE FULL BICX RESEARCH REPORT

In early May, BioCorRx (OTC:BICX) reached a key milestone when it received US FDA IND approval for its subcutaneous naltrexone pellet, BICX104, for the treatment of opioid and alcohol use disorders. The approval came about 30 days after filing, in line with expectations. In addition, in March, the Company raised $2.25 million from existing shareholders at $2.00/share.

BioCorRx, Inc. develops and markets medication-assisted treatment and behavioral therapy programs to treat opioid use disorder (OUD), alcohol use disorder (AUD), and weight-management. The Company's offerings combine proprietary cognitive-behavioral-therapy (CBT) and peer support with medications (primarily naltrexone) prescribed by a physician which can enable them to provide customizable solutions to their patients. BioCorRx has sold its Beat Addiction Recovery program for OUD and AUD since 2010.

Naltrexone implants of various types have been available for over two decades under compounding pharmacy guidelines, but none have ever gone through the FDA approval process. In 2018, BioCorRx had a pre-IND meeting with the FDA to seek guidance on getting approval for BICX102, a proprietary, implantable naltrexone pellet. The Company ultimately filed for a slightly different formulation (BICX104) based on preclinical and manufacturing factors. If all goes according to plan, the Company expects to begin clinical trials later this year and submit its NDA application for approval in 2022.

Opioid misuse has been a top public health issue for the past decade. The pandemic has reignited this concern as drug overdose deaths increased 18% in the twelve months ended May 2020 after having leveled off in the previous two years.

Our intrinsic value for BICX of $5.65/share is based on an NPV for an FDA-approved naltrexone implant for OUD and AUD, the Company's addiction recovery program, and the UnCraveRx program for weight management. Our model assumes BICX carries all R&D costs through approval (estimated range of $12-15 million) partially offset by research grants of nearly $10 million through 2023.

Several factors provide upside to our valuation including: additional research funding beyond our $10 million assumption, partnership that provides milestones and/or R&D cost sharing; a faster, or less-costly path to US approval; and the potential for sales in other geographies and indications as well as the possibility of additional approvals.

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