Case Study #1:
Establishment of an Affiliate Company in Another Region of the World to Help Finance and Develop a Product
The Partners of BioMed acquired a portfolio of intellectual property in the biomarker field and created a U.S.-based company to further develop and commercialize the portfolio. As part of this effort, we partnered with a New Zealand venture fund to establish and finance a separate New Zealand-based company in order to carry out similarly high quality research but at lower cost than might be the case for work performed in the U.S. The Partners licensed Australasian rights to the new company, created a geographic marketing agreement, and identified clinical collaborators in Europe for the New Zealand company. In addition to company formation, the Partners continue to provide on-going advisory services and assist in the management of the development program in New Zealand.
In this effort, we identified a biomarker with significant commercial potential, created two companies, identified capital efficient funding sources, and established a development plan that leveraged our expertise in diagnostics and clinical validation. Our corporate business development experience enabled us to propose, create, and negotiate the necessary term sheets, agreements, and legal documents. We also identified additional potential licensees, U.S.- based commercialization partners, additional indications for the biomarker, and created an international distribution site.
By establishing a New Zealand company as a strategic partner for a U.S. company, the product development work could be conducted in a more capital-efficient manner as compared with the equivalent effort undertaken in the United States. At the conclusion of the development work in New Zealand, all rights, excluding those in Australasia, will revert to the U.S. company. Substantial value will have been created for both the U.S.-based and New Zealand-based companies.
Case Study #2:
Evaluation of a Non-Core U.S. Unit for a European Multinational Healthcare Company and Development and Implementation of a Strategic Growth Plan for that Unit
The Partners of BioMed assisted a European multinational healthcare company by evaluating a non-core U.S. business unit and developing a growth strategy for the business. In its strategic evaluation, the Partners identified a range of U.S.-based growth opportunities including the expanded use of the unit's core product for additional applications and markets and the acquisition of products to expand the unit's competitive footprint. Subsequent to the initial assignment, the Partners were asked to evaluate a product opportunity, conduct diligence, and represent the European company in its discussions with the company that held the product targeted for acquisition by the unit. In its continuing association with the European company, the Partners identified additional U.S. license and acquisition opportunities.
The U.S.-based non-core business unit has become an important and strategic profit center for the European multinational healthcare company.
Case Study #3:
Serving as the U.S. Management Team of the U.S. Subsidiary of a Life Sciences Company Traded on the Australian Securities Exchange
The Partners of BioMed were engaged to provide strategic advice and serve as the U.S. management team of a clinical-stage life sciences company traded on the Australian Securities Exchange. In connection with this assignment, three Partners served as members of the Board of Directors of the U.S. subsidiary of the company. Beyond serving as strategic advisors to the company, the assignment encompassed the establishment of a presence for the company in the U.S., serving as a liaison with U.S. investors, and assisting company management to identify U.S. organizations and resources that might support the company.
Among the relationships in the U.S. that were established were the opportunity to conduct a clinical trial at a major U.S. medical research center; research conducted by company personnel located on the campus of a top U.S. research university; and, investor and public relations directed at U.S. investors through firms specializing in such activities.
During their tenure as the U.S. management team of the company, the Partners obtained and supported a listing for the company on the OTCQX that facilitated investment in the company by U.S. investors and provided additional liquidity to all investors. Trading volume doubled in about a year and the price of the company's stock also doubled. The Partners were able to improve relations with major U.S.-based shareholders. Additionally, the Partners were instrumental in the procurement of a grant from a major medical research foundation to support a clinical trial underway by the company.
Case Study #4:
Acquisition and Transformation of a Biological Products Business Unit into a Revenue-Generating Profitable Business
A Partner of BioMed acquired a small biological products business unit from a major pharmaceutical company and reoriented it. At the time of its acquisition, the unit did not conduct its own manufacturing – and it had no foreign operations or sales. Working with a small team, the Partner identified a synergistic company that had the capability to manufacture the business unit's products. Within months the business unit and the company merged. The combined company made use of the sales and marketing expertise of the Partner to enter into new markets and develop new products. The company also began to manufacture and sell its own products as well as manufacture products to be sold by other companies. Within a year, the company was generating positive cash flow. These actions enabled the company to acquire additional complementary business assets that brought in additional infrastructure, expanded capabilities, and the ability to generate higher cash flow and profits.
By building organizational infrastructure and additional capabilities through a roll-up acquisition strategy, the Partner grew the company into a global business that included several GMP facilities and facilities and organizations located on three continents. At the time of its sale to a major biologicals company and throughout almost all of its 14-year history, the company was profitable. Its international sales grew to forty percent of total revenues.
Case Study #5:
Development of Reimbursement and Regulatory Pathways for a Diagnostic Test Developed by a Start-Up Company: A Consultative Assignment
A Partner of BioMed was engaged by a startup diagnostics company based outside the U.S. to provide guidance from a commercial laboratory perspective in multiple areas, including operations, regulatory matters, and reimbursement issues. To that end, the Partner advised management on clinical validation of the diagnostic test, establishment of a U.S.-based laboratory operation, strategies for publication of peer reviewed articles, conducted health economics evaluations, recruited key opinion leaders, and prepared coverage and pricing documentation for discussions with insurance companies. The Partner provided a roadmap on regulatory matters to assure that the company would be compliant with current regulatory requirements and that management would be in a position to address changes in the regulatory environment.
The company successfully launched its diagnostic service in the U.S., has met all regulatory requirements, and continues to gain market share. Currently, its diagnostic test is reimbursed by many insurance carriers in the U.S. and it has begun to gain acceptance in several international markets.
Case Study #6:
Due Diligence and Restart of a Manufacturer of Protein Therapeutics: An Interim Management Assignment
European investors were referred through their U.S.-based attorneys to BioMed for the purpose of asking the Partners to conduct due diligence on a U.S.-based, biomanufacturing company that had ceased operations and that was available for sale. To that end, we carried out extensive and rapid scientific and business due diligence that led to the investors' decision to acquire the business. Coincident with the acquisition, the investors entered into a one-year interim management contract with BioMed.
Partners of BioMed assumed key management roles and strategically repositioned the company. We hired a small team of employees to restore, upgrade, and bring the biomanufacturing facility up to current operating standards. Therapeutic proteins were manufactured in compliance with FDA regulations. The facility was inspected and its drug manufacturing license re-approved by regulatory authorities. The biomanufacturing company now has a cGMP compliant facility capable of producing therapeutic proteins for commercial production. The Partners evaluated the company's clinical development portfolio and determined not to pursue products and indications that would lack institutional investor support because of regulatory or market hurdles. The Partners identified a new indication for a product that the company had produced that provided a significant market opportunity with little competition and a clear regulatory path forward.
Case Study #7:
Inventing New Technology to Advance a Company whose Current Technology Faces Regulatory and Other Roadblocks
A Partner of BioMed co-founded a biotechnology company having a unique delivery tool for enzyme replacement therapy. Within the first year following the founding of the company, the key personnel realized that there was a major regulatory hurdle facing the company that might well stand in the way of securing the necessary venture capital financing. To circumvent that issue, a core group including the Partner developed an alternative technology approach that solved the regulatory issue and, most importantly, induced subsequent rounds of venture capital investment.
The company developed its drug candidate using the newly developed technology and successfully brought the drug candidate into clinical trials with the assistance of a strategic partner. The company subsequently was acquired by a major player in the same strategic space.
Case Study #8:
Bringing an Israeli Medical Device Company to the U.S.
A Partner of BioMed co-founded a medical device company in Israel. The first prototype product was developed within two years following the company's formation. The Partner then was asked by the other founders to initiate commercialization of the product in the United States. The Partner led the entire regulatory process and obtained FDA approval within one year. In order to assure acceptance of the product by U.S. physicians, the Partner obtained the professional support of key U.S. opinion leaders who were experts in the technology underlying the product, established personal relationships with them, and arranged for the company to conduct clinical trials with each one of them to evaluate the company's product — in all cases resulting in positive results. These key opinion leaders then became members of the advisory committee for the company.
The Company successfully penetrated the U.S. market though its strategy of conducing clinical trials in the U.S. that were beyond those required by the FDA for regulatory approval. The Partner identified a strategic partner that initially invested in the company and ultimately bought the company, providing a substantial return to inventors and resulting in a very positive outcome for company founders and management.