Tag: healthcare

GoHealth, Inc. (GOCO) – Is there a Tailwind in the Forecast?

Posted on by slightbourne@noblecapitalmarkets.com


Friday, August 09, 2024

Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Q2 results below estimates. The company reported Q2 revenue and adj. EBITDA of $105.9 million and a loss of $12.3 million, respectively, below our estimates. Our revenue and adj. EBITDA estimates were $144.0 million and a loss of $6.3 million, respectively.

Preparing for AEP. The company has been testing Plan Fit Save, an initiative whereby it is compensated by health plan carriers for improving customer retention when GoHealth recommends consumers to keep their existing plans. We believe the combination Plan Fit Save, as well as the prospect for disruption to health plan benefits in the upcoming Annual Enrollment Period, could set the company up for a strong finish to the year.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Release – Ocugen, Inc. Announces FDA Approval of Expanded Access Program for Patients with Retinitis Pigmentosa

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on OCGN

MALVERN, Pa., Aug. 05, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that it has received notification from FDA to begin its expanded access program (EAP) for the treatment of adult patients, aged 18 and older, with retinitis pigmentosa (RP) with OCU400—a modifier gene therapy product candidate.

“Each clinical milestone achieved by OCU400 brings us closer to providing a potential one-time treatment for life to patients living with RP,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “With positive Phase 1/2 study data and an ongoing Phase 3 liMeliGhT (pronounced “limelight”) clinical trial, we now plan to work with clinicians, patients, and the RP community to provide access to OCU400 for eligible patients through our EAP. The EAP strengthens our commitment to serving RP patients—300,000 in the U.S. and Europe and 1.6 million globally.”

EAP allows patients who have unmet medical needs with serious or life-threatening conditions to access treatments outside of a clinical trial that are not yet approved by the FDA.

The OCU400 EAP is available for patients with early, intermediate to advanced RP with at least minimal retinal preservation who may benefit from the mechanism of action of OCU400 prior to approval of the Biologics License Application (BLA). Ocugen is actively dosing patients in the Phase 3 liMeliGhT clinical trial.

“RP patients with mutations in multiple genes currently have no therapeutic options. As a retinal surgeon, I am encouraged by the therapeutic potential of OCU400 to provide long-term benefit,” said Lejla Vajzovic, MD, FASRS, Director, Duke Surgical Vitreoretinal Fellowship Program, Associate Professor of Ophthalmology with Tenure, Adult and Pediatric Vitreoretinal Surgery and Disease, Duke University Eye Center, and Retina Scientific Advisory Board Chair of Ocugen. “The OCU400 EAP gives RP patients access to this novel modifier gene therapy outside of the ongoing Phase 3 study.”

“We are pleased to make OCU400 available to patients beyond our Phase 3 liMeliGhT clinical trial through this EAP,” said Dr. Huma Qamar, Ocugen’s Chief Medical Officer. “We are excited to expand our enrollment to include patients representing a diverse array of RP gene mutations. This program reflects our ongoing commitment to develop a safe and effective therapy for RP patients who may not have other treatment options.”

Ocugen previously announced that OCU400 has received orphan drug and Regenerative Medicine Advanced Therapy (RMAT) designations from FDA and that the European Medicines Agency (EMA) accepted the U.S.-based trial for submission of a Marketing Authorization Application (MAA). With the dosing of patients in the Phase 3 clinical trial program underway, OCU400 remains on track for targeted BLA and MAA approval in 2026.

About OCU400 EAP
The OCU400 EAP is a U.S.-only protocol for (1) eligible adult RP patients, 18 years and older, with early, intermediate to advanced disease with at least minimal retinal preservation, (2) patients who participated in the OCU400 Phase 1/2 study and who qualify for dosing in the contralateral eye, (3) patients who failed to meet inclusion criteria in the Phase 1/2 trial and ongoing Phase 3 liMeliGhT clinical trial who could benefit from OCU400, and (4) RP patients who can benefit from the mechanism of action of OCU400 prior to BLA approval.

Additional information on the OCU400 EAP will be available on www.clinicaltrials.gov.

About OCU400 Phase 3 (liMeliGhT) for RP
The Phase 3 liMeliGhT clinical trial, with a duration of one year, will have a sample size of 150 participants. One arm will include 75 participants with RHO gene mutations, and the other arm will include 75 participants who have mutations in other genes. Within each arm, participants will be randomized 2:1 to the treatment group (2.5 x1010 vector genomes/eye of OCU400) and untreated control group, respectively. Patients eight years of age and older with early to late-stage RP are being recruited to participate in the liMeliGhT study.

About OCU400
OCU400 is the Company’s modifier gene therapy product based on a nuclear hormone receptor (NHR) gene called NR2E3. This gene regulates diverse physiological functions within the retina, such as photoreceptor development and maintenance, metabolism, phototransduction, inflammation, and cell survival. Retinal cells in RP patients have a dysfunctional gene network, and OCU400 resets this network to reestablish a healthy cellular homeostasis—which has the potential to improve vision in patients with RP.

About Modifier Gene Therapy
Modifier gene therapy is designed to fulfill unmet medical needs related to retinal diseases, including IRDs, such as RP, Leber congenital amaurosis (LCA) and Stargardt disease, as well as multifactorial diseases like dry age-related macular degeneration (dAMD). Our modifier gene therapy platform is based on the use of NHRs, master gene regulators, which have the potential to restore homeostasis — the basic biological processes in the retina. Unlike single-gene replacement therapies, which only target one genetic mutation, we believe that our modifier gene therapy platform, through its use of NHRs, represents a novel approach that has the potential to address multiple retinal diseases caused by mutations in multiple genes with one product, and to address complex diseases that are potentially caused by imbalances in multiple gene networks. Currently, Ocugen has three modifier gene therapy programs in the clinic: OCU400, OCU410, and OCU410ST. In addition to the OCU400 Phase 3 liMeliGhT clinical trial, the OCU410 Phase 1/2 ArMaDa clinical trial for geographic atrophy (GA) secondary to dAMD and the OCU410ST Phase 1/2 GARDian clinical trial for Stargardt disease are currently underway. GA affects approximately two to three million people in the U.S. and EU combined and Stargardt disease affects nearly 100,000 people in the U.S. and EU combined.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patients’ lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
Head of Corporate Communications
Tiffany.Hamilton@ocugen.com

Release – Schwazze Sets Second Quarter 2024 Conference Call for August 13, 2024 at 5:00 P.M. ET

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on SHWZ

DENVER, July 30, 2024 (GLOBE NEWSWIRE) — Medicine Man Technologies, Inc., operating as Schwazze, (OTC: SHWZ) (Cboe CA: SHWZ) (“Schwazze” or the “Company”), will host a conference call on Tuesday, August 13, 2024 at 5:00 p.m. Eastern time to discuss its financial and operational results for the second quarter ended June 30, 2024. The Company’s results will be reported in a press release prior to the call.

The Schwazze management team will host the conference call, followed by a question-and-answer period. Interested parties may submit questions to the Company prior to the call by emailing ir@schwazze.com.

Date: Tuesday, August 13, 2024
Time: 5:00 p.m. Eastern time
Toll-free dial-in: (844) 825-9789
International dial-in: (412) 317-5180
Conference ID: 10191294
Webcast: SHWZ Q2 2024 Earnings Call

The conference call will also be broadcast live and available for replay on the investor relations section of the Company’s website at https://ir.schwazze.com.

Toll-free replay number: (844) 512-2921
International replay number: (412) 317-6671
Replay ID: 10191294

If you have any difficulty registering or connecting with the conference call, please contact Elevate IR at (720) 330-2829.

About Schwazze

Schwazze (OTC: SHWZ) (Cboe CA: SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale.

Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector.

Medicine Man Technologies, Inc. was Schwazze’s former operating trade name. The corporate entity continues to be named Medicine Man Technologies, Inc. Schwazze derives its name from the pruning technique of a cannabis plant to enhance plant structure and promote healthy growth. To learn more about Schwazze, visit http://www.schwazze.com/.

Investor Relations Contact

Sean Mansouri, CFA or Aaron D’Souza
Elevate IR
(720) 330-2829
ir@schwazze.com

AI Revolution in Healthcare: Simplify Healthcare Acquires Virtical.ai

Posted on by slightbourne@noblecapitalmarkets.com

In a groundbreaking move, Simplify Healthcare has announced its acquisition of Virtical.ai, setting the stage for a dramatic transformation in health insurance technology. This strategic merger, revealed on June 24, 2024, combines Simplify Healthcare’s established SaaS platform with Virtical.ai’s advanced artificial intelligence capabilities, promising to revolutionize how health insurance providers operate in an increasingly complex market.

The timing of this acquisition is particularly significant as the healthcare industry grapples with mounting pressures to personalize services, streamline operations, and navigate intricate regulatory landscapes. By integrating Virtical.ai’s AI prowess into its Simplify Health Cloud™ platform, Simplify Healthcare aims to empower health insurance companies (Payers) with sophisticated tools to address these challenges effectively.

At the core of this acquisition lies the transformative potential of AI-driven solutions. Virtical.ai’s technology, which has been trained on an extensive database of health plan-specific documents, excels in data extraction and comparison. This capability enables Payers to offer highly personalized plans and benefits to both employer and individual segments, potentially revolutionizing the way health insurance is customized to meet individual needs.

Simplify Healthcare’s leadership team has expressed enthusiasm about the merger’s potential to reshape the industry. They emphasize the ability of AI models to process complex documents such as Statements of Benefits and Coverage (SBCs) and Machine Readable Files (MRFs), highlighting the potential for significant advancements in plan comparison, selection, and price transparency.

The acquisition also addresses critical challenges in network management. Virtical.ai’s platform can identify gaps in Payer networks by analyzing provider and member locations. This feature allows Payers to strategically promote their network coverage strengths and address deficiencies, ensuring members have access to suitable providers within their area. Moreover, the ability to benchmark negotiated provider rates against competitors offers Payers valuable insights for rate-setting and targeted marketing initiatives.

Virtical.ai’s leadership shares the excitement about the merger’s potential impact. They highlight how their AI models, built on decades of industry experience, are positioned to drive membership growth and revenue when integrated with Simplify Healthcare’s enterprise SaaS platform.

The integration of Virtical.ai’s technology is expected to enhance several of Simplify Healthcare’s existing solutions, including Benefits1™, Provider1™, Service1™, Claims1™, and Experience1™. These enhancements promise to provide Payers with more precise solutions to complex challenges in delivering products, benefits, and provider data.

Simplify Healthcare’s strategic team underscores the acquisition’s importance in the face of market disruptions. They believe that combining their industry-leading platform with Virtical.ai’s innovative AI solutions in Health Plan Sales and Network Management will empower Payers to achieve growth despite facing disruptive market and regulatory forces.

This merger also reflects a broader industry trend towards leveraging AI and machine learning to improve efficiency and personalization. By utilizing both generative AI and machine learning algorithms on unstructured document content and structured data, the combined entity aims to deliver cutting-edge solutions to Payers navigating the complexities of AI integration.

As the healthcare landscape continues to evolve, this acquisition positions Simplify Healthcare at the forefront of the AI revolution in health insurance technology. The promise of more personalized health plans, optimized network coverage, and data-driven decision-making tools could significantly impact not only Payers but also brokers and, ultimately, healthcare consumers.

With this bold move, Simplify Healthcare and Virtical.ai are poised to play a pivotal role in shaping the future of health insurance in an increasingly digital and personalized world. Their combined expertise and technological capabilities have the potential to drive innovation, enhance efficiency, and improve the overall experience for all stakeholders in the health insurance ecosystem.

Take a moment to take a look at GoHealth Inc. (GOCO), a health insurance marketplace that leverages modern machine-learning algorithms and helps individuals find the best health insurance plan for their specific needs.

Quantum Leap: The Next Big Investment Opportunity in Healthcare?

Posted on by slightbourne@noblecapitalmarkets.com

Imagine a world where diseases are detected at the earliest stages, new life-saving drugs are developed in a fraction of the time, and medical resources are optimized to deliver the best possible care. This future may not be as far-fetched as it sounds, thanks to a revolutionary technology called quantum computing.

What is Quantum Computing?
Quantum computing is a mind-bending technology that harnesses the strange behavior of particles at the subatomic level. Unlike traditional computers that process information as binary bits (0s and 1s), quantum computers use quantum bits or qubits that can exist in multiple states simultaneously. This superposition phenomenon allows quantum computers to perform millions of calculations at once, making them exponentially more powerful than classical computers.

The Healthcare Revolution
While quantum computing may seem like something straight out of a science fiction movie, its potential applications in healthcare are very real and could transform the industry as we know it.

  1. Accelerating Drug Discovery
    One of the most promising applications of quantum computing is in the field of drug discovery. Finding new medicines is a painstakingly slow and expensive process, often taking decades and billions of dollars. Quantum computers can simulate complex molecular interactions at an unprecedented scale, allowing researchers to quickly identify promising drug candidates. This could dramatically shorten the drug development timeline, saving lives and billions of dollars.

Consider this: It takes an average of 10 years and $2.6 billion to develop a new drug from initial discovery to market approval. With quantum computing, pharmaceutical companies could potentially cut development times by years, significantly reducing costs and getting life-saving treatments to patients faster.

  1. Personalized Medicine
    We all have unique genetic makeups that influence our response to different treatments. Personalized medicine aims to tailor therapies to an individual’s genetic profile, but analyzing vast amounts of genomic data is a daunting task for classical computers. Quantum computers can process and identify patterns in complex genetic data, enabling truly personalized treatment plans that maximize efficacy and minimize side effects.

Imagine a future where your doctor can analyze your entire genome and prescribe a medication tailored specifically to your genetic makeup, minimizing the risk of adverse reactions or ineffective treatments. This level of precision could revolutionize healthcare, improving outcomes and reducing waste.

  1. Enhanced Medical Imaging
    Medical imaging techniques like MRI and CT scans generate massive amounts of data. Quantum computing can enhance image processing, improving clarity and resolution, enabling earlier detection of diseases like cancer. Early detection is key to successful treatment and could save countless lives.

With quantum-enhanced imaging, doctors could potentially identify tumors and other abnormalities at much earlier stages, significantly increasing the chances of successful treatment and survival.

  1. Optimized Healthcare Logistics
    Healthcare systems involve intricate logistics, from managing hospital resources to optimizing patient care. Quantum computing’s ability to solve complex optimization problems can help hospitals better manage staff, equipment, and patient flow, leading to improved efficiency and reduced costs.

By optimizing resource allocation and patient flow, quantum computing could help hospitals reduce wait times, improve patient experiences, and ultimately deliver better care at lower costs.

The Investment Opportunity
While quantum computing is still in its early stages, the potential payoffs in healthcare are staggering. Tech giants like IBM, Google, and startups like Rigetti Computing are investing heavily in quantum research. As the technology matures, we can expect to see a surge of investment opportunities in quantum computing companies and healthcare firms that leverage this technology.

Analysts estimate that quantum computing could create a $450 billion to $850 billion annual market by 2045, with healthcare being one of the prime beneficiaries. Early investors in this space could see massive returns as the technology takes off.

Of course, there are challenges to overcome, such as building stable, large-scale quantum computers and developing algorithms tailored for healthcare applications. However, the potential rewards are vast, both in terms of human lives saved and financial returns for savvy investors who recognize the transformative power of quantum computing in healthcare.

Quantum computing holds the promise to revolutionize healthcare by accelerating drug discovery, enabling personalized medicine, enhancing medical imaging, and optimizing resource management. While the technology is still in its early stages, the potential benefits for medicine are enormous. As we continue to explore and develop quantum computing, the future of healthcare looks brighter than ever, offering new hope for patients and medical professionals alike.

Novavax Soars on Major Sanofi Partnership, Opening New Doors for Biotech Investors

Posted on by slightbourne@noblecapitalmarkets.com

In a dramatic turn of events, shares of Novavax skyrocketed over 130% on Friday after the struggling vaccine maker announced a landmark deal with global pharmaceutical giant Sanofi. This multibillion-dollar agreement could prove to be a game-changer, not just for Novavax’s outlook, but for biotech investors evaluating the emerging opportunities across the vaccine technology landscape.

The centerpiece of the deal is a co-commercialization partnership for Novavax’s protein-based Covid-19 vaccine beginning in 2025. Sanofi, with its vast global reach and resources, will take the lead in marketing and distributing the shot in most major markets outside of regions where Novavax already has existing commercial agreements.

For Novavax, which has grappled with sluggish demand and manufacturing challenges for its Covid vaccine, gaining access to Sanofi’s commercial juggernaut could unlock vastly greater market penetration worldwide. As a relatively small biotech player, going it alone has proven tremendously difficult against the entrenched dominance of mRNA giants like Pfizer and Moderna.

Investors clearly perceive the blockbuster potential in marrying Novavax’s innovative vaccine technology with Sanofi’s large-scale commercial capabilities and existing healthcare footprint. Expanded patient access could drive significant upside for Novavax’s revenues and growth trajectory in the coming years, breathing new life into a company that was on the brink.

But the deal goes far beyond just commercializing Novavax’s existing Covid vaccine. In a strategic masterstroke, Sanofi also secured the rights to develop new combination vaccines using Novavax’s breakthrough Matrix-M adjuvant technology, along with its Covid shot as a foundational component.

This pipeline partnership opens up a world of lucrative new product opportunities spanning respiratory illnesses like influenza to other viral targets. With Sanofi’s vast resources and deep experience in vaccines, the French pharma leader could rapidly advance and widely commercialize groundbreaking combination shots powered by Novavax’s underlying technology platform.

From an investment perspective, the potential to create multiple new high-value assets from a proven backbone of innovative biotech is hugely compelling. Sanofi is putting over $1 billion on the table in upfront fees and milestone payments tied to development and commercial objectives. Novavax will also earn royalties on all future product sales utilizing its technology.

Crucially, this deal relieves immense financial pressure from Novavax’s shoulders. Just a few months ago, the company warned of “substantial doubt” about its ability to continue operating through a dwindling cash position. Now flush with fresh capital from Sanofi and newly monetized royalty streams, Novavax can comfortably lift its “going concern” status while funding its own vaccine pipeline initiatives.

Investors should see the partnership as transformative, clearing the dark clouds of existential risk that had been swirling over Novavax and positioning the biotech for long-term sustainability through diversified vaccine revenue channels.

But Novavax’s good fortune goes beyond just its own prospects. The validation of its unique Matrix-M adjuvant and protein-based vaccine technology by a pharma titan like Sanofi should resonate across the broader biotech landscape. Smaller innovators working on novel vaccine platforms or therapeutic approaches could see heightened investor interest and appetite for collaborations.

The deal underscores how big pharma incumbents remain hungry for cutting-edge technologies to refresh and future-proof their product pipelines. More acquisitions and mutually beneficial licensing deals could emerge as large players double down on biotech externally to fuel new innovation cycles.

For biotech venture investors scouting breakthrough opportunities and transformative technology platforms, the Novavax-Sanofi partnership should serve as an encouraging proof-of-concept. Companies advancing truly differentiated science with clear competitive advantages and value-driving datasets now have a highly visible pathway to lucrative partnerships, exits or harnessing corporate funding muscle to propel their own commercialization dreams.

In life sciences industries where innovation is the key to disruption, this high-profile deal should instill greater confidence around investing in upstart biotechs clearing novel clinical and technological hurdles. The prospects of future value realization and exit opportunities just got a welcome booster shot.

While Novavax finally resolved one existential crisis, it may have just birthed an exciting new era of opportunity across the biotech investment landscape.

New Eli Lilly-Amazon Deal Signals Emerging Opportunities in Direct-to-Consumer Pharmaceuticals

Posted on by slightbourne@noblecapitalmarkets.com

The newly announced partnership between pharmaceutical giant Eli Lilly and e-commerce behemoth Amazon to enable direct-to-consumer medication delivery is sending shockwaves through the biotech and healthcare sectors. The deal, which allows customers to receive select Eli Lilly prescription drugs like diabetes, migraine, and weight-loss treatments via Amazon’s online pharmacy, represents a major shift in how pharmaceutical companies get products into the hands of consumers

For emerging biotech and healthcare companies watching this space, the Eli Lilly-Amazon partnership illuminates massive growth opportunities in the burgeoning direct-to-consumer pharmaceutical market. Cutting out the middlemen of insurance providers and brick-and-mortar pharmacies enables pharma companies to get closer to patients and potentially earn higher margins.

Under the partnership revealed this week, patients can receive Eli Lilly medications prescribed through the LillyDirect online platform or by their regular doctor, with Amazon handling the fulfillment and two-day delivery logistics. Axios’ Jacob Gardner points out this allows Eli Lilly “to reach more patients directly and sidestep more traditional pharmaceutical sales constraints.”

The collaboration helps both industry titans accomplish key objectives. For Eli Lilly, it expands their direct-to-consumer reach at a pivotal time following the approval of blockbuster weight-loss drug Zepbound last November. Amazon, meanwhile, continues growing its healthcare presence following the acquisition of PillPack and launch of Amazon Pharmacy in 2020.

Executives at emerging biotech and pharmaceutical companies would be wise to study this latest deal’s blueprint. By partnering with logistics giants like Amazon, FedEx, or UPS on the shipping side or digital health platforms on the consumer-facing end, they could unlock highly lucrative direct-to-consumer sales channels.

Beyond cutting out middlemen that take a cut of sales, direct-to-consumer pharma models can foster stronger patient relationships, bolster brand loyalty, and provide a wealth of data and analytics on consumer behaviors. Those insights allow companies to precisely tailor marketing and pricing strategies to drive further growth.

From the investor perspective, directly delivering cutting-edge treatments straight to patient doorsteps holds massive upside potential. Drug developers can keep more of the profits by circumventing insurance providers. But investing in the right direct-to-consumer pharmaceutical plays requires careful due diligence.

Investors need to scrutinize logistics capabilities, consumer marketing and branding strengths, and data analytics competencies in evaluating these emerging opportunities. The biggest winners will have a clear advantage in one or more of those mission-critical areas.

The overarching theme is clear – by cutting out the tangle of middlemen in the traditional pharmaceutical ecosystem, innovative companies embracing the direct-to-consumer model could potentially earn higher revenues, margins, and valuations. The ripple effects of the Eli Lilly-Amazon deal are likely just beginning for the healthcare investing space.

For investors willing to conduct thorough research and identify the pioneers, the emerging direct-to-consumer pharmaceutical market could birth the next generation of blockbuster biotech and healthcare companies.

Learn more about Noble Capital Markets’ Emerging Growth Virtual Healthcare Equity Conference on April 17-18 here.

Biden’s Scrutiny of Private Equity Healthcare Deals: A New Hurdle for Investors?

Posted on by slightbourne@noblecapitalmarkets.com

The healthcare industry has long been a fertile ground for private equity investments, with firms eagerly scooping up stakes in hospitals, physician practices, and ancillary service providers. However, a recent move by the Biden administration to scrutinize these deals more closely could signal turbulent times ahead for investors eyeing opportunities in the healthcare space.

In February 2024, the White House announced plans to establish an interagency taskforce dedicated to investigating the effects of private equity ownership on healthcare costs, quality, and workforce compensation. This move comes amid growing concerns from lawmakers and advocacy groups about the potential negative impacts of private equity firms’ profit-driven strategies on patient care and healthcare affordability.

The taskforce’s mandate is broad, encompassing a comprehensive examination of how private equity business models influence everything from staffing levels and worker wages to service availability and pricing dynamics across various healthcare sectors. While the specific policy implications remain uncertain, the heightened scrutiny alone could cast a cloud of uncertainty over future private equity healthcare deals, particularly smaller acquisitions of physician practices, nursing homes, and ancillary service providers.

For investors, this development represents a potential new hurdle in an already challenging regulatory landscape. Private equity firms have long been drawn to the healthcare sector due to its recession-resistant nature, steady cash flows, and the potential for operational improvements and consolidation plays. However, the increased regulatory oversight could make it more difficult for these firms to execute their traditional playbook of cost-cutting, leveraged buyouts, and aggressive growth strategies. Nathan Cali, Head of Healthcare Investment Banking at Noble Capital Markets said, “Certainly, government oversight never means more business to be done, and alternatively may result in fewer healthcare services, healthcare innovations and reduce opportunities for patients. Private equity typically fuels great innovation with the necessary growth funds to already thriving good businesses. Government regulations and oversight may reduce these types of activities.”

One area likely to face heightened scrutiny is the acquisition of physician practices by private equity firms. These deals have been a contentious issue, with critics arguing that private equity ownership can lead to higher healthcare costs, a focus on profitable procedures over patient needs, and potential conflicts of interest. If the taskforce recommends additional regulations or restrictions on such acquisitions, it could dampen private equity firms’ appetite for these investments, potentially limiting exit opportunities for investors.

Similarly, private equity ownership of nursing homes and long-term care facilities has been a subject of intense debate, with concerns over staffing levels, quality of care, and the diversion of resources towards profit maximization. Increased oversight in this sector could lead to stricter requirements for private equity firms, potentially impacting their ability to implement cost-cutting measures and limiting the financial returns on these investments.

Beyond the direct impact on private equity firms, the taskforce’s findings and recommendations could also have broader implications for the healthcare sector as a whole. If the investigation uncovers evidence of harmful practices or negative outcomes associated with private equity ownership, it could prompt lawmakers to pursue more comprehensive regulatory changes or industry-wide reforms.

Such changes could include enhanced transparency requirements, stricter oversight of billing practices, or even limitations on the types of healthcare entities that can be acquired by private equity firms. These measures could potentially level the playing field between private equity-owned and non-profit healthcare providers, but could also create additional compliance burdens and operational challenges for all industry participants.

For investors, navigating this shifting landscape will require a keen eye for regulatory risks and a deep understanding of the potential impacts on specific healthcare subsectors. While the taskforce’s ultimate recommendations remain uncertain, investors should be prepared for potential changes in valuations, deal structures, and exit strategies for private equity healthcare investments.

Noble Capital Markets’ Senior Research Analyst Robert Leboyer states, “The Administration’s provisions for Medicare price negotiations in the Inflation Reduction Act have added uncertainty to a high-risk business, causing reduction in the value of future drugs and discontinuation of some drugs in development. Small company valuations were reduced and many were unable to raise capital. Additional regulation for healthcare facilities would add administrative costs and reduce profitability, reducing the incentives and competition in providing the best care for patients.”

Additionally, investors may need to reassess their due diligence processes to scrutinize not only the financial and operational aspects of potential investments but also the potential regulatory and reputational risks associated with private equity ownership in the healthcare space.

Despite the challenges, the healthcare sector remains an attractive target for private equity firms due to its resilience, growth potential, and the ongoing need for operational efficiencies and consolidation. However, the Biden administration’s heightened scrutiny serves as a reminder that the pursuit of profits must be balanced against the broader societal impact and responsibilities inherent in the healthcare industry.

As the taskforce’s work unfolds, investors would be wise to closely monitor developments and adapt their strategies accordingly. Those who can navigate this new reality adeptly may find themselves well-positioned to capitalize on the enduring opportunities in the healthcare sector, while those who fail to adjust could face significant headwinds in a rapidly evolving regulatory and political landscape.

Healthcare Investment Ideas on Display at the Noble Capital Markets Emerging Growth Virtual Healthcare Equity Conference

Posted on by cpatches

Get the Virtual Conference eBook

Watch the Presentation and Q&A Replays

  • Emerging Growth Public Healthcare Company Executive Presentations
  • Q&A Sessions Moderated by Noble’s Analysts and Bankers
  • Scheduled 1×1 Meetings with Qualified Investors

Noble Capital Markets, a full-service SEC / FINRA registered broker-dealer, dedicated exclusively to serving emerging growth companies, is pleased to present the Emerging Growth Virtual Healthcare Conference, taking place April 17th and 18th, 2024. This virtual gathering is set to be an immersive experience, bringing together a unique blend of investors, industry leaders, and experts in the life sciences, healthcare, and medical device sectors.

Part of Noble’s Robust 2024 Events Calendar

The Emerging Growth Virtual Healthcare Conference is part of Noble’s 2024 event programming, featuring a range of c-suite interviews, in-person non-deal roadshows throughout the United States, two more sector-specific virtual equity conferences, and culminating in Noble’s preeminent in-person investor conference, NobleCon20, to be held at Florida Atlantic University in Boca Raton, Florida December 3-4. Keep an eye out for the official press release on NobleCon20 coming soon.

Check out the calendar of upcoming in-person non-deal roadshows here.

Sign up to receive more information on Noble’s other virtual conferences here.

What to Expect

The Emerging Growth Virtual Healthcare Conference will feature 2 days of corporate presentations from up to 50 innovative public healthcare, biotech, and medical device companies, showcasing their latest advancements and investment opportunities. Each presentation will be followed by a fireside-style Q&A session proctored by one of Noble’s analyst or bankers, with questions taken from the audience during the presentation. Panel presentations are planned, featuring key opinion leaders in the healthcare sector, providing valuable insights on emerging trends. Scheduled one-on-one meetings with public company executives, coordinated by Noble’s dedicated Investor Outreach team, are also available to qualified investors.

Why Your Company Should Present

Looking to increase awareness in your company and increase liquidity? Paid participation in Noble’s investor conferences, both virtual and in-person, provides that opportunity, with a tailored experience aimed at delivering substantial value. After 40 years of serving emerging growth companies, and the investors who follow them, Noble has built an investor base eager to discover where the next success story lies.

Noble’s investor base is relevant and, in many cases, new to your company. Noble’s dedicated Investor Outreach team provides unmatched exposure to investors that can invest in your company, including small money managers, family offices, RIAs, wealth managers, self-directed investors, and institutions. Most of Noble’s investors specifically seek undervalued, overlooked, emerging investment opportunities.

The cost to present includes your corporate presentation with a Q&A session proctored by one of Noble’s analysts or bankers, a webcast recording, scheduled 1×1 meetings with qualified investors, and marketing on Channelchek.

Benefits for Investors

The emerging growth healthcare space may be poised for a breakout year.  The recent dislocation in the healthcare and biotech spaces has created compelling valuation profiles for many companies. Hear directly from the c-suite of the next innovators in this space and learn about new investment opportunities. The Q&A portion of each presentation gives you the opportunity to have your questions answered during or after the proctored session. The planned panel presentations are sure to provide expert insight on growing trends in the healthcare space. And, for qualified investors, one-on-one meetings are available with company executives; scheduled by Noble’s dedicated Investor Outreach team. All from the comfort of your own desk, and at no cost.

How to Register

Limited presenting slots are available

Publicly traded companies in the healthcare space can submit their registration details here.

If you have any questions about presenting, please contact events@noblecapitalmarkets.com

Investor / Guest attendees can register here

Interested in becoming a sponsor of Noble’s virtual and in-person investor conferences?

Contact events@noblecapitalmarkets.com for sponsorship information.

AI in Healthcare: The Next Frontier for Investors?

Posted on by slightbourne@noblecapitalmarkets.com

In the ever-evolving world of technology, few terms have captured the imagination of investors quite like artificial intelligence (AI). From autonomous vehicles to virtual assistants, AI has permeated nearly every facet of modern life, disrupting traditional business models and creating new opportunities for growth and innovation.

One sector that is increasingly feeling the transformative impact of AI is healthcare. As the industry grapples with challenges such as rising costs, workforce shortages, and the need for more personalized and efficient care, AI is emerging as a powerful tool to address these issues and unlock new frontiers in medicine.

The applications of AI in healthcare are vast and varied, ranging from drug discovery and disease diagnosis to patient monitoring and virtual nursing assistants. At the forefront of this revolution are companies that are harnessing the power of AI to develop cutting-edge solutions and drive technological advancements in the field.

One area where AI is making significant strides is medical imaging and diagnostics. Companies like Enlitic, a pioneer in deep learning for radiology, are developing AI systems that can analyze medical images with unprecedented accuracy, aiding in the early detection of diseases and reducing the risk of misdiagnosis. By automating and enhancing the analysis of X-rays, CT scans, and MRI images, these AI solutions have the potential to improve patient outcomes while reducing the workload on healthcare professionals.

Another promising application of AI in healthcare is drug discovery and development. Traditionally, the process of bringing a new drug to market has been time-consuming and costly, often taking years and billions of dollars in research and clinical trials. However, AI is revolutionizing this process by analyzing vast amounts of data, identifying promising drug candidates, and accelerating the drug discovery pipeline.

Companies are leveraging machine learning algorithms to search through millions of potential drug compounds, predicting their efficacy and safety profiles with remarkable accuracy. This not only speeds up the drug development process but also increases the likelihood of successful clinical trials and faster time-to-market for new therapies.

Beyond drug discovery and medical imaging, AI is also playing a crucial role in personalized medicine and patient care. Companies are developing AI-powered virtual healthcare assistants that can provide personalized medical advice, triage patients, and even monitor chronic conditions remotely. By leveraging natural language processing and machine learning, these AI solutions can offer accessible and affordable healthcare services, particularly in underserved or remote areas.

For investors, the proliferation of AI in healthcare presents both opportunities and challenges. On the one hand, the potential for groundbreaking innovations and disruptive technologies in this sector could translate into significant returns for those who identify and invest in the right companies early on. However, the healthcare industry is also heavily regulated, and navigating the complex web of regulatory approvals and clinical trials can be a significant hurdle for AI-driven healthcare solutions.

Furthermore, as with any emerging technology, there are ethical considerations and potential risks associated with the use of AI in healthcare. Concerns around data privacy, algorithmic bias, and the potential for AI to perpetuate or exacerbate existing healthcare disparities must be carefully addressed to ensure the responsible and equitable deployment of these technologies.

Despite these challenges, the investment community is eagerly watching the AI healthcare space, recognizing the immense potential for transformative innovations and lucrative returns. As the adoption of AI in healthcare continues to accelerate, companies that can successfully navigate the regulatory landscape, mitigate risks, and deliver tangible solutions that improve patient outcomes and healthcare efficiency are likely to emerge as leaders in this burgeoning field.

For savvy investors, the key to capitalizing on the AI healthcare revolution lies in conducting thorough due diligence, understanding the competitive landscape, and identifying companies with robust AI capabilities, strong intellectual property portfolios, and a clear path to commercialization and scalability.

While AI may be a buzzword that often moves markets, in the healthcare sector, it represents a genuine paradigm shift with the potential to save lives, reduce costs, and transform the way we approach healthcare delivery. As such, investors who can separate the hype from the reality and identify the true pioneers in this space may be well-positioned to reap the rewards of this technological revolution.

noble capital markets emerging growth virtual healthcare equity conference

Healthy Returns Ahead: Investor Outlook for the Telemedicine Sector

Posted on by slightbourne@noblecapitalmarkets.com

The COVID-19 pandemic accelerated a trend that was already underway – the transition to virtual healthcare. Telehealth and telemedicine platforms that enable patient-doctor video visits surged in popularity with the rise of social distancing. This shift towards healthcare digitization appears poised to continue shaping the industry landscape long after the pandemic subsides.

Companies at the forefront of virtual care technology saw demand for their platforms skyrocket since early 2020. Now, with telehealth becoming entrenched in patient and provider norms, these virtual health firms are emerging as stocks to watch. Their continued growth could transform how healthcare is accessed and delivered.

Surging into the Mainstream

The coronavirus outbreak necessitated remote interactions, making virtual doctor appointments a necessity. Healthcare providers rapidly ramped up telehealth offerings to comply with public health mandates while ensuring patient access.

According to McKinsey, telehealth utilization soared from 11% of US consumers in 2019 to 46% in 2020. Virtual healthcare visits increased 38-fold from the pre-pandemic baseline.

This abrupt shift illuminated the viability of remote care. Patients and providers alike found telehealth appointments efficient and convenient compared to in-office visits. Virtual options grant easy access for patients while maximizing provider capacity.

Significant majorities of patients now prefer a telehealth option according to surveys. With Covid risks waning, medical practices face patient demand to maintain virtual visit capabilities. This bodes well for companies specializing in telemedicine software and infrastructure.

“Virtual care proved its worth during an extremely trying time for the healthcare system,” said Alan Warren, MD and Chief Medical Officer of Epic Health Services. “Now patients know its value. Providers have invested in it. There’s no going back.”

New Market Leader?

Hims & Hers Health (NYSE: HIMS) operates a telehealth platform focused on serving millennial and gen-Z demographics. Its model emphasizes accessible virtual care for conditions like skin, sexual health, mental health, and primary care.

Since pandemic onset, Hims & Hers has seen tremendous growth as young consumers flocked to its digital offerings. Quarterly revenues grew 74% year-over-year in Q3 2023. The company now boasts over a million subscribers and expanded its medical provider network 10-fold.

Hims & Hers shares surged over 15% this past week on the back of strong Q3 results that beat analyst estimates. The company increased its FY 2023 revenue guidance by $5 million.

As adoption of virtual care increases, platforms like Hims & Hers that cater to digital-native populations could see outsized gains. Younger demographics are leading the charge in embracing telehealth’s convenience and privacy.

“Hims & Hers is emerging as uniquely positioned to capture the virtual care market for younger users who prefer seeking healthcare from their smartphones,” said Morgan Stanley analyst Daniella Perry. She projects the company will top $500 million in sales by 2025.

The New Normal

While uncertainty always exists around new technologies, virtual healthcare appears poised for growing prominence even post-pandemic. Patients favor the enhanced access, efficiency, and safety it affords. Providers can boost capacity and revenue with integrated telemedicine capabilities.

Regulatory changes also signal momentum. Recently proposed congressional legislation aims to permanently remove geographic restrictions on telehealth while increasing reimbursements to incentivize adoption. If passed, such measures would further propel widespread virtual care.

Meanwhile, more providers are investing in platforms to offer hybrid models blending physical and digital visits. Partnerships between health systems and technology vendors are becoming commonplace.

“Virtual healthcare is becoming standard,” said John Smith, Chief Medical Officer at MedCity Health. “We’ve implemented secure video visit capabilities across all our primary care clinics. Patients love the flexibility of on-demand telehealth for many common conditions and follow-ups.”

For innovative companies enabling this care transformation, analysts see blue sky ahead. As telehealth becomes entrenched in care delivery norms, firms providing user-friendly, scalable platforms could capture enormous value. The next time you need to see a doctor, the visit may very likely take place online.

Veradigm Bets on AI, Acquires ScienceIO for $140M

Posted on by slightbourne@noblecapitalmarkets.com

Healthcare technology firm Veradigm announced a deal this week to purchase artificial intelligence (AI) startup ScienceIO for $140 million in cash. The acquisition provides Veradigm with advanced AI capabilities to derive insights from its health data assets.

Chicago-based Veradigm offers data platforms and software solutions for healthcare stakeholders including providers, insurers, and pharmaceutical companies. The company claims its network covers over 400,000 healthcare providers and 200 million patients.

ScienceIO, founded in 2019, has developed AI models and platforms specifically for healthcare applications. Its natural language processing models can extract information from complex medical text and records.

Powered by this AI, Veradigm aims to launch next-generation analytics products that enhance clinical decision-making and improve patient outcomes across its customer base.

Accelerating Growth Through AI

The merger agreement comes as Veradigm looks to reposition itself as a high-growth data analytics leader. Management believes integrating ScienceIO’s technology is key to that transformation.

In the press release, Veradigm Interim CEO Yin Ho said the acquisition “will be able to provide more highly differentiated and advanced products to provider, payer and life sciences customers.”

The company’s Executive Chairman Greg Garrison also called the deal “a natural next step in the strategy…to drive continued growth across our business units.”

Veradigm plans to leverage ScienceIO’s platform to build custom natural language processing models trained on its own proprietary health data. Running advanced analytics on its comprehensive provider and patient dataset will uncover previously untapped insights.

The focus will be developing AI-enabled offerings while ensuring full compliance with healthcare data privacy regulations. This will likely necessitate keeping modeling and computation on Veradigm’s controlled systems rather than via public cloud services.

Presenting Company Registration Now Open! Don’t miss Noble Capital Markets’ Emerging Growth Virtual Healthcare Equity Conference on April 17-18. This exclusive virtual event connects investors with 50 leading public biotech, healthcare services, and medical device companies. Presenting company slots are available…Read More

Near-Term Growth and Long-Term Potential

Incorporating ScienceIO’s technology throughout its product portfolio will help accelerate new feature development, per Veradigm management. Enhanced offerings could then drive near-term revenue growth.

But the larger potential impact is establishing Veradigm as a leader in next-generation intelligent healthcare systems. AI-powered analytics promise to transform areas like clinical diagnostics, patient risk assessment, and treatment decision support.

Veradigm highlighted that its unique combination of data breadth and advanced analytics can lead to “higher quality, lower cost care for patients.” This goal aligns with the current shift towards value-based care in the healthcare sector.

The transaction is expected to close within weeks, subject to customary closing conditions. ScienceIO’s team will likely join Veradigm’s existing technology group.

Plans for integrating operations and migrating customers to enhanced AI offerings will be critical during the post-merger integration process. Realizing the promised growth synergies rapidly will demonstrate the strategic logic of the deal.

What Competition and Customers Can Expect

For competitors, Veradigm gaining potent AI abilities raises the stakes in the race to provide smarter healthcare analytics tools. AI-driven insight platforms are seen as a major battleground in the industry.

The deal pressures other players to advance their own AI or seek technology acquisitions to keep pace. Industry titans like Optum and IQVIA have already been aggressive on the M&A front, snapping up emerging analytics firms.

Ultimately, it’s healthcare payers and providers that need to see material improvements from AI adoption. They will expect Veradigm’s new data products to deliver actionable insights that improve patient outcomes and the bottom line.

If Veradigm can successfully integrate ScienceIO’s capabilities across its client verticals, it will cement its positioning as a partner that can drive impact from healthcare data analytics.

But the company must also tread carefully, as the sensitive nature of health data makes privacy preservation paramount. Responsible data usage and ethics around AI will determine customer and public perception.

AstraZeneca Shares Drop Despite Strong 2024 Outlook

Posted on by slightbourne@noblecapitalmarkets.com

Shares of pharmaceutical giant AstraZeneca fell over 6% despite the company projecting double-digit growth for 2024. Investors were disappointed by AstraZeneca missing Q4 earnings expectations due to rising costs. However, smaller healthcare firms may offer more upside potential.

AstraZeneca reported fourth quarter core earnings per share of $1.45, below analyst estimates of $1.50. Higher research and development costs weighed on profits. Meanwhile, total revenue edged above expectations at $12.02 billion.

The company expects low double-digit percentage increases in both total revenue and core earnings per share in 2024. This robust guidance is driven by AstraZeneca’s oncology and rare disease drugs.

However, shares dropped as investors focused on the earnings miss and product mix in the latest quarterly results. While AstraZeneca maintains a strong long-term outlook, its scale and mature product portfolio limit rapid growth.

This has led some investors to turn their attention to younger healthcare companies in search of higher growth potential. Smaller biotechs and emerging medtech firms can offer more upside, albeit with higher risk.

For example, cancer immunotherapy developer Silverback Therapeutics went public in late 2020 and has seen its stock price triple over the last year. The company is advancing treatments that harness the body’s immune system to fight cancer.

Other high-growth areas include digital health, where newly public firms like GoodRx are disrupting pharmacy and drug pricing. And healthcare tech provider Oak Street Health has surged over 200% since its 2020 IPO.

These younger healthcare firms tend to have higher volatility compared to big pharmas like AstraZeneca. But their focus on new innovations and faster growth in underpenetrated markets make them appealing for growth-oriented investors.

However, due diligence is required as many of these stocks go on to underperform or even fail. Factors like clinical trial results, regulatory approvals, and market adoption can make or break emerging health stocks.

Diversification across multiple companies can help mitigate the risk. Investing in a healthcare-focused ETF is one method to gain diversified exposure to both mature drugmakers and higher-growth emerging stocks.

Additionally, many biotech and medtech IPOs have been impacted by the 2022/2023 bear market. This offers an opportunity for investors to buy promising stocks at lower valuations.

Overall, AstraZeneca maintains a healthy long-term outlook supported by its deep pipeline of new drugs. But near-term headwinds like rising costs and the latest earnings miss dragged shares lower.

This illustrates how even strong incumbent firms face challenges sustaining rapid growth. For investors seeking higher growth potential, carefully selected emerging healthcare stocks can provide more upside.

However, realizing this potential requires thorough due diligence. Not all emerging companies succeed, making diversification and patience key when investing in new healthcare names. But buying into the right stocks early can result in tremendous gains over the long-term.

The health sector’s constant innovation ensures exciting new companies will continue disrupting incumbents. While mature pharmas like AstraZeneca play a key role in the market, fast-growing upstarts are where outsized returns often lie.