Company highlights key strategic initiatives to grow underlying value in 2023 and beyond

Company announces it is in strategic discussions to develop BE-Smart cancer test globally

Company to hold a conference call Tuesday, March 28, 2023, at 11:00AM ET

Garden City, NY, March 28, 2023 (GLOBE NEWSWIRE) — ProPhase Labs, Inc. (NASDAQ: PRPH), a growth oriented and diversified diagnostics, genomics and biotech company, today reported its financial and operational results for the year ended December 31, 2022.

Financial highlights for the full year ended December 31, 2022, include the following:

Corporate highlights for the year ended December 31, 2022, and subsequently include the following:

Ted Karkus, ProPhase Lab’s Chief Executive Officer, commented, “While working on Wall Street in the 90’s, I learned that when it comes to investing, particularly in small cap development stage companies, bet on the jockey and not the horse. My fellow shareholders, you have all bet on the right jockey. Our results over the past decade and in particular over the last few years, which have proven to be a very difficult period for many companies, have been extraordinary for our company, and 2022 was no exception. I am so proud of our entire management team for what we have collectively accomplished, and the platform that we have built together to provide an exciting future for our company and our shareholders.”

Mr. Karkus continued, “A decade ago, we inherited a cold brand with declining sales. Management had the skill and foresight to turn it around and sell it for $50 million dollars. Unlike the managements of many other companies, we rewarded shareholders with stock buybacks and special dividends and did not squander a single penny. We then looked for opportunities and were patient, only swinging at balls that we felt could result in homeruns for our company. With the emergence of COVID-19, we found an opportunity to help people while generating immediate and significant returns. The financial results speak for themselves.”

“I am truly pleased with our full year 2022 revenues of $122.6 million and adjusted EBITDA of $38.6 million,” continued Mr. Karkus. “One item to clarify is a one-time year-end charge of $5.9 million related to bad debt write-offs. This charge relates to the first half of 2022 when HRSA stopped reimbursing COVID-19 testing providers for claims without insurance. While this write-off is prudent, we still hope to collect insurance on many of these claims.”

“I believe that it is our destiny to build a multi-billion-dollar company together,” continued Mr. Karkus. “While our financial results have been stellar, we believe that our diversification strategy, which began in 2022, will make our previous successes seem trivial in comparison to what is yet to come. Over the past two years, we have taken advantage of the bear market in micro-cap development stage biotech and life sciences companies and licensed and/or acquired some fantastic assets that will gestate and become potentially billion-dollar franchises on their own.”

“As our COVID-19 and flu testing slows in 2023, we believe that the underlying value of our other subsidiaries will continue to grow rapidly and will more than make up for the slowdown in our diagnostics business and will reward our shareholders significantly over time. Several of these subsidiaries are already beginning to operate exceptionally well.”

Mr. Karkus elaborated, “Revenues from our Pharmaloz Manufacturing subsidiary are up approximately 100% year-over-year and we expect them to triple over the next two years. We already have the demand and are only limited by how quickly we can build out our capacity. Our Nebula Genomics subsidiary is growing even faster. We estimate revenues for this business will grow more than 100% in 2023 and that is before we leverage off of our superior retail distribution network. If we are successful in gaining acceptance in major retailers, then sales will grow even more dramatically. Retail is something we know better than anyone and we expect to execute on this in the near term.”

“We are confident that combining Nebula Genomics’ comprehensive genomic testing with our CLIA-certified lab capabilities will lead to faster turnaround times and lower price points, driving additional demand,” Mr. Karkus continued. “We also plan to offer low-pass genomic testing at significantly lower price points. This will allow us to leverage our distribution network of more than 40,000 food, drug, and mass retail stores to further expand direct-to-consumer and big-box retail distribution of Nebula’s Genomic sequencing products and services. Additional goals include the development of partnerships for Nebula Genomic’s proprietary library, research collaborations with universities, and leveraging the Nebula Genomics database. Furthermore, we believe our lab will be one of the most sophisticated in the nation and therefore could become the go to spot for all genetic sample processing. Each of these initiatives could significantly grow sales as we look forward to 2023 and beyond.”

Mr. Karkus continued, “We are very excited to be developing the BE-Smart Esophageal Cancer Test. Testing is ongoing at mProbe in collaboration with Dr. Hartley and The Mayo Clinic as well as with several other Key Opinion Leaders around the country. As described in recent press releases, we believe the BE-Smart test has multi-billion-dollar potential with minimal competition and significant unmet need. We expect to pursue initial commercialization of the BE-Smart test later this year as a laboratory developed test (LDT) and for research use only (RUO) for cash payment. Full commercialization backed by insurance is expected to commence in the first half of 2024 once CPT codes are obtained for insurance reimbursement. In parallel, we are also in current discussions to explore strategic opportunities to potentially develop, commercialize and distribute our BE-Smart test globally. These global opportunities may be even larger than in the United States. In the longer-term we feel that our knowledge gained from the BE-Smart test could also lead to some significant opportunities for therapeutic applications for Esophageal Adeno Carcinoma (EAC).”

“As shareholders, we look for catalysts to drive performance,” added Mr. Karkus. “We believe our ProPhase BioPharma subsidiary has exciting potential in both the short-term and the long-term. We are currently conducting clinical studies of Equivir (OTC/dietary supplement), a broad based anti-viral, and anticipate launching Equivir (OTC/dietary supplement) in the United States in the second half of this year. We believe that this product has significant potential as a dietary supplement and leverages our core infrastructure from when we owned the Cold-EEZE Cold Remedy brand. Our Linebacker cancer compound (LB-1) continues to demonstrate excellent pre-clinical results as a potential cancer co-therapy for several billion-dollar cancer drugs. These studies are continuing at Dana Farber Cancer Institute, and we look forward to reporting additional progress in the second quarter of this year. Longer term, we do not plan to spend significantly on this development path and plan to sell, license or joint venture Linebacker once Phase 1 human clinical studies are completed at minimal cost to ProPhase shareholders.”

“And finally, our diversification strategy for our diagnostics laboratory is proceeding nicely. Our clinical lab and our genomics lab have both been fully constructed with equipment installed. We are in the final stages of completing clinical validations to ensure testing accuracy for regulatory obligations. Our genomics laboratory is equipped with state-of-the-art genomics equipment, which provides us with the opportunity to potentially be the low-cost provider of all whole genome sequencing in the United States, as well as a leading provider of other genomics tests.
We will also continue to evaluate and pursue additional strategic and synergistic acquisitions to build our precision medicine and genomics research capabilities with the help of world-renowned genomics expert, George Church, co-founder of Nebula Genomics and Russ Altman, both of whom are advisors to ProPhase Labs.”

Mr. Karkus concluded, “As the largest shareholder in the Company, my primary concern has always been on creating value and a return on investment, on both an absolute and per share basis. While long-term performance is really just a series of good short-term executions, I remain focused on both the near-term and the long-term. In 2022, we returned a total of 1.3 million shares to the Company from the combination of our common stock repurchase plan and cashless stock options exercised at a total value of $11.3 million. Our recently announced new $6 million dollar stock repurchase program is a testament to our significant execution over the past two years as well as the Board’s confidence in our multi-faceted strategy to continue to build value for our shareholders long-term. Suffice it to say, the Board of Directors and I are excited for the future of our Company.”

Financial Results
Year Ended December 31, 2022

Net revenue for the year ended December 31, 2022 increased $43.6 million, or 55%, to $122.6 million compared to $79.0 million for the year ended December 31, 2021. The increase in net revenue was the result of a $39.8 million increase from diagnostic services, and a $3.8 million increase from consumer products. The increase in net revenue from diagnostic services was due to increased COVID-19 testing volumes performed as a result of the spread of the Omicron variant, which emerged in early 2022. Overall diagnostic testing volume increased from approximately 600,000 tests for the year ended December 31, 2021 to approximately 1,000,000 tests for the year ended December 31, 2022, of which 58% and 29% were reimbursed by the HRSA uninsured program, respectively. The average variable consideration received was $108.00 per adjudicated test for the year ended December 31, 2022 compared to $114.00 per adjudicated test for the year ended December 31, 2021 .

Cost of revenues for the year ended December 31, 2022 was $52.0 million, comprised of $39.9 million for diagnostic services and $12.1 million for consumer products. Cost of revenues for the year ended December 31, 2021 were $37.1 million comprised of $29.4 million for diagnostic services and $7.6 million for consumer products.

We realized a gross profit of $70.7 million for the year ended December 31, 2022, as compared to $42.0 million for the year ended December 31, 2021. The increase for the year ended December 31, 2022 compared to the year ended December 31, 2021 of $28.7 million attributable to an increase in diagnostic services, while consumer products remained flat. For the year ended December 31, 2022, our overall gross margin was 57.6% as compared to 53.1% for the year ended December 31, 2021. Gross margin for diagnostic services was 63.2% and 57.1% for the years ended December 31, 2022 and 2021, respectively. The increase in gross margin was principally due (i) increased efficiencies in our lab processing, (ii) decreased sample collection costs and (iii) a decrease in cost of testing materials. Gross margin for consumer products was 15.5% and 27.1% for the years ended December 31, 2022 and 2021, respectively. Gross margin for consumer products has historically been influenced by fluctuations in quarter-to-quarter production volume, fixed production costs and related overhead absorption, raw ingredient costs, inventory mark to market write-downs and timing of shipments to customers.  

Diagnostic expenses for the year ended December 31, 2022 were $12.0 million as compared to $9.2 million of diagnostic expenses for the year ended December 31, 2021. The increase in diagnostic expenses of $2.8 million was primarily due to increased COVID-19 testing volumes performed as a result of the spread of the Omicron variant, which emerged in early 2022, partially offset by a greater proportion of costs allocated to cost of revenues as a result of the nature of agreements with network providers.

General and administration expenses increased $11.9 million for the year ended December 31, 2022 to $34.4 million as compared to $22.5 million for the year ended December 31, 2021. The increase in general and administration expenses for the year ended December 31, 2022 as compared to the year ended December 31, 2021 was primarily related to an increase in personnel expenses and professional fees associated with our diagnostic services business. Additionally, we recorded a bad debt expense of $5.9 million representing a direct write-off of trade receivables we have determined to be uncollectible.

Research and development costs for the year ended December 31, 2022 were $0.7 million as compared to $0.5 million for the year ended December 31, 2021. The increase in research and development costs in fiscal 2022 as compared to fiscal 2021 was principally due to a decrease in personnel expenses associated with our diagnostics services business.

Our aggregate cash and cash equivalents and restricted cash as of December 31, 2022 were $9.1 million as compared to $8.7 million at December 31, 2021. Our working capital was $44.8 million and $45.8 million as of December 31, 2022 and 2021, respectively. The increase of $0.5 million in our cash and cash equivalents for the year ended December 31, 2022 was primarily due to the proceeds from the sale and maturities of marketable debt securities of $8.2 million, proceeds from dispositions of property and other assets of $0.5 million, and $28.7 million in cash provided by operating activities, offset by (i) purchases of marketable securities of $6.8 million, (ii) cash dividend payments of $9.3 million, (iii) repayment of note payable of $7.0 million, (iv) repurchase of common shares for $2.2 million, and (v) capital expenditures of $4.1 million.

Company CEO Named Top 10 Most Innovative Healthcare Leaders To Watch In 2023

ProPhase Labs CEO Ted Karkus Named One of Inc Magazine’s 10 Most Innovative Healthcare Leaders to Watch in 2023

Garden City, NY, April 28, 2023 (GLOBE NEWSWIRE) — ProPhase Labs, Inc. (NASDAQ: PRPH) (“ProPhase”), a next-generation biotech, genomics and diagnostics company, is pleased to announce that Ted Karkus, CEO, has been named one of Inc Magazine’s 10 Most Innovative Healthcare Leaders to Watch in 2023. The annual listing represents dynamic healthcare leaders redefining the world with their innovative products and leadership.

Mr. Karkus was recognized by Inc Magazine for his visionary leadership in the healthcare industry, as well as his dedication to driving innovation and improving patient outcomes. Under his guidance, ProPhase Labs has rapidly evolved from a legacy over-the-counter healthcare products and supplements company to a diversified, next-generation biotech, genomics and diagnostics company with multiple new products and subsidiaries.

In the article, Mr. Karkus was highlighted for his leadership stewarding ProPhase Labs through the c-virus pandemic, and his efforts to bring cutting-edge technologies and therapies to the healthcare industry through subsidiaries ProPhase Diagnostics, ProPhase BioPharma and Nebula Genomics. Mr. Karkus was instrumental in ProPhase’s quick pivot into the CV-19 testing business at the onset of the pandemic, generating over $200Mn in revenue over the past few years and fueling the company’s long-term growth and diversification strategies.

Mr. Karkus commented, “I am honored to be recognized by Inc Magazine as one of the 10 Most Innovative Healthcare Leaders to Watch for 2023. This recognition is a testament to the hard work and dedication of the entire ProPhase Labs team, and I look forward to continuing to drive innovation and improve patient outcomes in the years ahead. With Nebula Genomics, and the potential game changer diagnostics and therapeutics we are developing, including our BE-Smart Esophageal Cancer Test, Linebacker cancer compounds, and broad based Equivir anti-virals, as well as our new fully diversified, state-of-the-art clinical lab and genomics testing lab, I promise that we are just getting started and that there is a lot more to come!”

Diamond Equity Research Initiates Coverage on ProPhase Labs Inc. (NASDAQ: PRPH) $20 PRICE TARGET

NEW YORK, May 01, 2023 (GLOBE NEWSWIRE) — Diamond Equity Research, a leading equity research firm with a focus on small capitalization public companies has initiated coverage of ProPhase Labs Inc. (NASDAQ: PRPH). The in-depth 32-page initiation report includes detailed information on the ProPhase’s business model, services, industry, valuation, management, and risks.

The full research report is available here. Highlights from the report include:

• Diagnostics Business Enabling Pivot Toward Niche and Emerging Business Segments: ProPhase’s strategic evolution from a predominantly diagnostics-centric company to a multifaceted healthcare organization is underscored by its ability to capitalize on the success and cash generation of its diagnostics division. By investing in and growing healthcare companies such as genomics and biopharma, the company expands its market presence and fosters revenue diversification. The company’s management is ambitiously striving to transform ProPhase Labs into an all-encompassing healthcare powerhouse, with diagnostics and genomics pinpointing disease origins, contract manufacturing delivering top-tier production capabilities, and the biopharma division driving the development of cutting-edge therapies and treatments.
• Solid Financial Performance Showcasing Substantial Progress: The company reported strong growth across all its major business divisions for the year ended 2022. In 2022, ProPhase Labs reported revenue of $122.64 million, a significant increase from the $79.04 million recorded in 2021. This translates to a year-over-year (y-o-y) growth rate of 55.16%. In 2022, the diagnostics business itself experienced a 63.3% revenue growth, mainly due to increased COVID-19 testing volumes in response to the spread of the Omicron variant. Other divisions, such as contract manufacturing and genomics, have also reported impressive growth numbers. We anticipate a contraction in diagnostics revenue for 2023 and 2024 due to changing market dynamics. To offset this, ProPhase is focusing on growth in BioPharma, Contract Manufacturing, and Genomics divisions. The BioPharma division aims to fully commercialize its esophageal cancer test by H1 2024, while Contract Manufacturing and Genomics divisions are expanding their client base and distribution channels.

• Valuation: The market has been conservative in valuing ProPhase, possibly undervaluing its potential and expertise across multiple segments due to a lack of understanding of the unique strengths and synergies between divisions. The genomics business and esophageal pre-cancer test operate in promising markets with billion-dollar opportunities. The management remains strongly optimistic about its genomics business and expects over 100% growth in 2023. These businesses are regarded as somewhat de-risked, given their exceptional value proposition and the overall market undervaluation of the company. With its impressive competitive positioning, exceptional product offerings, and tremendous growth potential within the genomics market, it can be reasonably argued that Nebula, as an independent entity, has the potential to command a valuation in the range of $80-$120 million. Furthermore, the company’s Equivir and Linebacker portfolios are supported by a strong sound scientific background and present high upside optionality in terms of shareholder value creation. We assessed the company’s value at around $344 million or $20.00 per share using a combination of DCF and SOTP valuation methodologies, allocating equal weightage to both approaches. The DCF assumptions include a discount rate of 12.5% and a terminal growth rate of 1.5%. By using the median 2024e EV/Revenue multiple for each business division and their forecasted revenue numbers, we have determined the value of each segment. Subsequently, we aggregated these values to derive the overall SOTP valuation for the company, providing a detailed and nuanced perspective on the company’s worth. However, the valuation is contingent on the company’s successful execution and is subject to change with new information or progress in development and commercialization processes.
• Significant Momentum Across Nascent Business Domains: ProPhase is strategically positioned to capitalize on emerging opportunities across its contract manufacturing, genomics, dietary supplements, and biopharma divisions. The contract manufacturing division, PMI, has experienced significant revenue growth due to an expanding client base, an extended manufacturing agreement with Mylan, and facility improvements. Management expects a 200% increase in production capacity over the next two years, projecting to triple the division’s revenue from $8 million to $25 million by 2024. The genomics division, Nebula, is set to benefit from the growing demand for direct-to-consumer genetic testing, driven by factors such as customized healthcare solutions, precision medicine, and a decrease in whole genome sequencing costs. Nebula excels as the price and quality leader in the industry, providing valuable DNA testing insights and maintaining a competitive position among low-cost genotyping service providers. An extended distribution network and partnerships with research-focused universities will likely fuel further expansion in this field. The dietary supplements segment targets the growing health and wellness market, while the biopharma division develops innovative products, such as the BE-Smart esophageal cancer test, addressing urgent medical needs within a multi-billion-dollar market. It is being developed in collaboration with the Mayo Clinic and may be commercialized as early as Q1 2024. The biopharma division is also developing Linebacker, a cancer co-therapy with excellent pre-clinical results being developed in collaboration with Dana Farber Cancer Institute and Harvard University scientists. Additionally, ProPhase has displayed a remarkable ability to identify and execute value-enhancing acquisitions at highly favorable market valuations.
• Executives With a Proven Track Record of Execution and Adaptability: The leadership of ProPhase Labs, under Ted Karkus’ supervision, has skillfully navigated the company’s growth by organically developing the diagnostics business and swiftly growing it into a $100 million business. The management team has accomplished remarkable growth and profitability by prudently allocating resources and investing in advanced genomic sequencing tools and innovative drug-development projects. This adept approach to managing growth and resources highlights the team’s ability to deliver sustained success while continuously exploring new avenues in healthcare innovation. The team has also exhibited exceptional adaptability in modifying strategies, as demonstrated by their swift response to the discontinuation of the HRSA uninsured program for COVID-19 testing. Moreover, the company is capitalizing on its vast biopharma experience and utilizing genomics as a strategic advantage to create synergies across diagnostics, genomics, and biopharma business divisions. The management led by Ted Karkus’ successfully turned around the flagship Cold-EEZE brand, significantly growing revenues before selling the brand to Mylan for $50 million in 2017. Notably, Ted Karkus previously forced the restructuring, turnaround, and new direction for ID Biomedical, a Canadian biotech company, ultimately leading to its acquisition by GlaxoSmithKline for over $1.4 billion.