Author: Randy Chase

At the end of December, the FDA approved yet another biosimilar, Yusimry (adalimumab-aqvh) from Coherus Bioscience. Yusimry is a tumor necrosis factor blocker approved as a subcutaneous formulation. It is indicated for plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis.

Yusimry is the seventh biosimilar to be approved for AbbVie’s blockbuster Humira (adalimumab).

This approval marks the thirty third (33) biosimilar in the US and the 7th biosimilar to Humira. None of the Humira biosims are currently available for sale in the US. Per the terms of its agreement with AbbVie, Coherus (as with the others) will launch in the U.S. in July of 2023.

Last year was a lean year for new biosimilar approvals….. only four products. That compares poorly compared with 2019 when 10 biosimilars were approved.

Pricing for Yusimry is unlikely to be released until the product is close to its 2023 launch date.

Last week the FDA approved a new ORAL therapy, Recorlev (levoketoconazole) from Xeris Biopharma Holdings, for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative. 

Cushing’s is a rare disease and Recorlev was granted an Orphan designation. There are fewer than 20,000 individuals with a Cushing’s diagnosis in the US and fewer with the endogenous hypercortisolemia diagnosis. 

Xeris did not announce pricing for Recorlev. The therapy is a next generation version of ketoconazole (tablets), a relatively inexpensive drug but not indicated for endogenous hypercortisolemia. That being said, there are plenty of examples where the new therapy is priced well above its sister legacy formulation. Several therapies have been approved for Cushing’s in recent years and all are considered specialty therapies. 

Xeris did not announce distribution details for Recorlev, however, they have launched a patient support HUB which has all the hallmarks of using the specialty pharmacy channel. Recorlev will be available later in Q1-22.

Click here to access prescribing information

We are catching up on the wave of FDA approvals that happen in the waning hours of the year.

The FDA approved Apretude (cabotegravir), from Viiv, for use in at-risk adults and adolescents for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV.

Apretude is an extended-release injectable suspension as a gluteal intramuscular injection only . It is first administered as two initiation injections one month apart, and then every two months thereafter (total of 6 doses in year 1). Patients can start treatment with Apretude or take oral cabotegravir (Vocabria) for four weeks to assess how well they tolerate the drug.

Uptake has increased measurably since the introduction of Truvada, an oral medication also indicated for PrEP. However, compliance with the daily oral regimen has not been exemplary. It is believed that a periodic injection of Apretude will increase compliance rates.

Apretude includes a boxed warning to not use the drug unless a negative HIV test is confirmed. It must only be prescribed to individuals confirmed to be HIV-negative immediately prior to starting the drug and before each injection to reduce the risk of developing drug resistance. It appears that this testing requirement will mean that patients will be seeing a healthcare professional for the testing and injection.

Apretude has a list price of $3,700 per dose (or $22,200 per year, for six doses). By comparison, Truvada (brand) is priced at $21,000 per year. However, Truvada is also now available as a generic priced at a very low cost of $500 annually with a coupon.

Apretude is expected to ship to wholesalers and specialty distributors in early 2022.

In the final hours of 2021, the FDA approved a number of new drugs. One of these therapies is Adbry (tralokinumab-ldrm) from Leo Pharma. Adbry, an interleukin-13 antagonist, is indicated for the treatment of moderate-to-severe atopic dermatitis in adults 18 years or older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Tralokinumab is a human monoclonal antibody that inhibits interleukin-13 (IL-13), a cytokine which plays a key role in AD inflammation.

There are an estimated 16.5 million adults in the U.S. living with atopic dermatitis, with approximately 6.6 million categorized as living with moderate-to-severe disease

Leo Pharma did not announce pricing at this time.
ICER published the following price references (including their estimate for Adbry):
Tralokinumab (Adbry) — $25,700-$35,000 per year (estimate)
Abrocitinib — $30,600-$41,800 per year.
Olumiant — $24,400-$33,300 per year (US list price: $29,000)
Rinvoq — $30,400-$41,500 per year (US list price: $64,300)
Dupixent — $29,000-$39,500 per year (US list price: $41,800)

Adbry is supplied in 150 mg pre-filled syringes for Sub-Q administration. The initial dose of 600 mg (four 150 mg injections) is followed by 300 mg (two 150 mg injections) administered every other week.

Adbry is the first biologic launched by LEO Pharma in the United States and is expected to be available in pharmacies by February 2022. Given the size of the size of the potential patient population and that the other therapies in this segment are not in limited distribution, it is likely Adbry will not be launched through LD.

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LEO Pharma announces FDA approval of Adbry (tralokinumab-ldrm)

The first and only treatment specifically targeting IL-13 for adults with moderate-to-severe atopic dermatitis

MADISON, N.J. — December 28, 2021 (BUSINESS WIRE)–LEO Pharma Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Adbry (tralokinumab-ldrm) for the treatment of moderate-to-severe atopic dermatitis in adults 18 years or older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Adbry can be used with or without topical corticosteroids. Adbry is the first and only FDA approved biologic that specifically binds to and inhibits the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms.1,3,4

“Adbry will be an important addition to our therapeutic armamentarium as a treatment designed to specifically target and neutralize the IL-13 cytokine, thereby, helping patients manage their atopic dermatitis.”

“Today’s FDA approval of Adbry is a major milestone for LEO Pharma and for the millions of people living with moderate-to-severe atopic dermatitis who struggle to find effective control for this chronic and debilitating disease,” said Anders Kronborg, Chief Financial Officer and Acting Chief Executive Officer of LEO Pharma A/S. “As our first biologic in the U.S., Adbry signifies important progress in our mission of advancing the standard of care in medical dermatology.”

The approval of Adbry is based on safety and efficacy results from the ECZTRA 1, 2 and ECZTRA 3 pivotal Phase 3 trials, which included nearly 2,000 adult patients with moderate-to-severe atopic dermatitis.1 Safety data was evaluated from a pool of five randomized, double-blind, placebo-controlled trials, including ECZTRA 1, 2 and ECZTRA 3, a dose-finding trial, and a vaccine response trial.1

In all three pivotal trials, Adbry 300 mg every other week alone or with topical corticosteroids (TCS) as needed met the primary endpoints at Week 16 as measured by an Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and/or at least a 75% improvement in the Eczema Area and Severity Index score (EASI-75), and the secondary endpoint of reduction of weekly average Worst Daily Pruritus NRS of ≥ 4 points on the 11-point itch NRS.1

In clinical trials, the safety of Adbry was well established with an overall frequency of adverse events comparable with placebo.1 The most common adverse events (incidence ≥1% and greater than placebo) were upper respiratory tract infections (mainly reported as common cold), conjunctivitis, injection site reactions, and eosinophilia.1

“Atopic dermatitis can be severe and unpredictable, which makes it not only challenging for patients to achieve long-term disease control, but also for clinicians to treat, since there are limited treatment options for this burdensome chronic skin disease,” said Jonathan Silverberg, MD, PhD, MPH, Associate Professor of Dermatology at George Washington University School of Medicine and Health Sciences, and tralokinumab clinical trial investigator. “Adbry will be an important addition to our therapeutic armamentarium as a treatment designed to specifically target and neutralize the IL-13 cytokine, thereby, helping patients manage their atopic dermatitis.”

Last week the FDA approved Leqvio, from Novartis Pharmaceuticals. Leqvio is a first-in-class, RNAi sub-Q therapy indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of low density lipoprotein cholesterol (LDL-C).

The startup dose is given via subcutaneous injection by a healthcare professional. The next dose is given after 3 months with subsequent doses every 6 months. Before starting Leqvio the patient should be on a diet to lower cholesterol and a statin.

Novartis priced Leqvio at $3,250 per dose in the U.S., meaning the first year of treatment will cost $9,750 and subsequent years $6,500. That range falls in line with the current list prices of two existing PCSK9 therapies—around $5,400 to $5,850 for Amgen’s Repatha and Regeneron’s Praluent.

As an in-office procedure, Leqvio injections will be covered under the Medicare Part B. But, coverage through Part B could be an advantage for Leqvio over Repatha and Praluent. Physicians will be reimbursed for Leqvio ASP plus 6%. The other two drugs are covered by Part D under the pharmacy benefit.

Given the relatively large patient population and relatively low cost for a specialty drug, it is unlikely that Leqvio will be channeled through a limited distribution specialty pharmacy program. Leqvio qualifies as a specialty pharmacy therapy mainly because it ‘fits’ the specialty class of therapy carved out by Repatha and Praluent.

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FDA approves add-on therapy to lower cholesterol among certain high-risk adults

FDA has approved Leqvio (inclisiran) injection as a treatment to be used along with diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low-density lipoprotein cholesterol (LDL-C). Leqvio works to reduce circulating levels of LDL-C, commonly known as “bad cholesterol.”

Leqvio is approved at a 284 mg dose administered as an initial under-the skin injection, a second dose at three months, and continued treatment once every six months after that point.

Diseases or Conditions
HeFH is a life-threatening condition in which patients have a mutation in a small group of genes that controls the way the body clears cholesterol. As a result, patients have extremely high levels of LDL-C. People with HeFH generally have cholesterol levels two to three times higher than normal. These individuals are at increased risk of cardiovascular events, such as heart attack, stroke, and coronary artery disease. HeFH occurs in approximately 1 in 250 individuals.

ASCVD involves the buildup of cholesterol plaque in arteries. Approximately 18.3 million American adults (8%) have ASCVD. Clinical ASCVD is an umbrella term and includes conditions such as acute coronary syndromes (sudden, reduced blood flow to the heart), peripheral arterial disease, heart attack and stroke.

Effectiveness
The effectiveness of Leqvio was studied in three randomized, double-blind, placebo-controlled trials that enrolled 3,457 adults with HeFH or clinical ASCVD. Enrolled participants were taking maximally tolerated statin therapy but required additional LDL-C lowering based on their risk for cardiovascular events. In all three studies, the main effectiveness outcome measure was the percent change in LDL-C from the beginning of the trial to day 510 (month 17). In each trial, participants received under-the-skin injections of either 284 mg Leqvio or a placebo on four separate days: day 1, day 90 (month 3), day 270 (month 9), and day 450 (month 15).

Study 1 enrolled 1,561 adults with ASCVD. At day 510, the Leqvio group had an average LDL-C decrease of 51% whereas the placebo group had an average LDL-C increase of 1%. Study 2 enrolled 1,414 adults with ASCVD. At day 510, the Leqvio group had an average LDL-C decrease of 46% whereas the placebo group had an average LDL-C increase of 4%. Study 3 enrolled 482 adults with HeFH. At day 510, the Leqvio group had an average LDL-C decrease of 40% whereas the placebo group had an average LDL-C increase of 8%.

The public relations battle surrounding White Bagging is heating up. Who’s on each side?

Depends on who you ask….!

• On one side, hospitals are claiming that their very existence is being threatened due to White Bagging policies.
• On the other side are the PBMs and the payers.

But, is there yet a third side? We will get to that. 

First, what is White Bagging?

As defined by the hospitals in the article link below….. White Bagging consists of “policies that require hospitals administering certain high-cost medications in an outpatient setting [actually inpatient as well] to receive those medications from third parties contracted with the health plan, instead of providing those medications directly from the hospital pharmacy inventories.” Increasingly, those third parties are specialty pharmacies acting as specialty distributors, under a distributor’s license (no prescription required) or as the pharmacy (with a prescription). 

What’s at stake? Money and control.

The number of rare therapies approved over the past two years has mushroomed. Most of the therapies have been $HUGE$ dollar meds that are hospital administered, often at leading national medical centers. These providers are very concerned about money and control. If they can buy directly and bill under often outdated, traditional contract terms (which never envisioned meds costing in the hundreds of thousands of dollars for a one-time infusion and may still pay them at U&C rates) then chances are they will realize a larger Net profit. If a specialty pharmacy is inserted into that scenario, they may not be able to realize any profit if the SP directly bills the PBM as a pharmacy claim or payer via a medical claim. 

It is no surprise that the hospitals are now upping the ante and turning to the courts and even state legislatures, where they may have significant influence, to seek relief and regain control. 

But…. who is the third party to this battle? Manufacturers.The pharmaceutical manufacturers proliferated the “White Bagging” war by selecting one or a handful of specialty pharmacies to be their preferred distributor(s) for these new infused therapies. Traditional distributors can’t perform all the functions of a specialty pharmacy as they are prohibited from making direct patient contact. Manufactures realized that SPs can help them out with managing patient care, ensuring compliance, tracking outcomes for FDA reporting, in addition to all the traditional SP patient stuff such as clearing prior authorizations and financial assistance. When payers and PBMs realized what was happening they got creative and saw a way to insert utilization review and tighter benefits management into the mix, things that SPs are also adept at juggling. 

It is also noteworthy to mention that SPs are also inventorying their meds for distribution. Traditional distributors charge manufacturers a percentage for their limited services…. better to pay an SP for the full-service package vs. just “park, pack, and ship.” 

So, it is surprising that the hospital lobby is focusing its ire only on the payers and PBMs, allowing the manufacturers off the hook. Then again, there are a lot of big research dollars that flow from manufacturers to the same big medical centers in new drug trials….. just sayin’. 

So, read the article below for a good update on what the leading payers are doing related to “White Bagging”.
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Payers Attempt to Impose “White-Bagging” Policies on Hospitals

CLICK HERE TO READ THE FULL ARTICLE

The FDA has approved a new INFUSED biologic, Vyvgart (efgartigimod alfa-fcab, Argenx), for treatment of generalized Myasthenia Gravis (gMG) in adults who are acetylcholine receptor antibody positive. gMG is a rare, chronic autoimmune, neuromuscular disease.

Myasthenia gravis is characterized by debilitating and potentially life-threatening muscle weakness and rapid fatigue of any of the muscles under voluntary control. The disease can affect people of any age and is more common in women younger than 40 and in men older than 60. Roughly 3 percent of people who develop gMG will die from it.

There is no cure for myasthenia gravis, but treatment can help relieve other signs and symptoms, such as double vision, drooping eyelids, and difficulties with speech, chewing, swallowing and breathing.

Prior to the approval of Vyvgart, therapies to control gMG include corticosteroids such as prednisone (Rayos), immunosuppressants (e.g., Azasan, Imuran), mycophenolate mofetil (Cellcept), cyclosporine (Sandimmune, Gengraf, others), methotrexate (Trexall) or tacrolimus (Astrograf XL, Prograf, others). Intravenous therapies incude plasmapheresis, intravenous immunoglobulin (IVIg), and monoclonal antibodies such as Rituximab (Rituxan) and eculizumab (Soliris).

The prevalence of gMG in the United States is estimated at 14 to 20 per 100,000 population, which translates into 36,000 to 60,000 cases in the United States. gMG has a low incidence rate of 2.1 to 5.0 per million people per year in the US.

Pricing for Vyvgart was not released upon approval. By reference, Soliris is currently priced at $675,000 per year. Distribution details were not released; however, it is presumed that Vyvgart will launch into limited distribution similar to Soliris.

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FDA approves Vyvgart for treatment of myasthenia gravis

The FDA announced the approval of Vygart for treatment of the chronic autoimmune, neuromusucal disease myasthenia gravis in adults who are positive for acetylcholine receptor antibody positive adults.

The approval of the investigational antibody fragment designed to target the neonatal Fc receptor is the first for the new drug class, according to a press release.

“There are significant unmet medical needs for people living with myasthenia gravis, as with many other rare diseases,” Billy Dunn, MD, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in the press release. “Today’s approval is an important step in providing a novel therapy option for patients and underscores the agency’s commitment to help make new treatment options available for people living with rare diseases.”

In a randomized, double-blind, placebo controlled, multicenter Phase 3 trial completed in 2020, patients with myasthenia gravis with acetylcholine receptor antibodies who received Vyvgart (efgartigimod, Argenx) responded to treatment at a higher rate as compared with placebo.

Since the therapy reportedly decreases levels of immunoglobulin, experts warn of an increased risk of infection. Hypersensitivity reactions are also possible, including eyelid swelling, shortness of breath, and rash. In the cases of hypersensitivity or existing infection, treatment should be either discontinued or delayed, according to the press release.

The FDA approved a new, subcutaneous biologic last week, Tezspire (tezepelumab-ekko) from Amgen and AstraZeneca, an add-on maintenance treatment for adult and pediatric patients (12+) with severe asthma. Tezspire is a first-in-class biologic for this complex condition.

Severe asthma impacts many of the 34 million people living with the disease worldwide. It affects their breathing and can severely limit day-to-day activity. The treatment has proven effective across a spectrum of causes of inflammation (but not indicated for acute bronchospasm or status asthmaticus).

Tezspire is the result of a collaboration agreement by Amgen and AstraZeneca that started in 2012. The companies will share costs and profits equally. AstraZeneca will lead development and Amgen will lead manufacturing. Amgen and AstraZeneca will jointly commercialize Tezspire in the US. Tezspire will enter the segment now led by Xolair (omalizaub) for patients with allergic asthma and Dupixent (dupilumab) for patients with eosinophilic asthma. Analysts forecast Teszpire to break the $$billion mark within three years of launch.

Tezspire will enter the market at an anticipated price of $28,000 per year. Distribution details were not released. Given that both Xolair and Dupixent are only available through limited distribution it is likely that Tezspire will also launch through LD.

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FDA Approves Tezspire (tezepelumab-ekko) in the U.S. for Severe Asthma

First and Only Biologic to Consistently and Significantly Reduce Exacerbations in a Broad Population of Severe Asthma Patients
Only Biologic for Severe Asthma Approved With no Phenotype or Biomarker Limitations

THOUSAND OAKS, Calif., Dec. 17, 2021 /PRNewswire/ — Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved Amgen and AstraZeneca’s Tezspire™ (tezepelumab-ekko) for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.1

Tezspire was approved following a Priority Review by the FDA and based on results from the PATHFINDER clinical trial program. The application included results from the pivotal NAVIGATOR Phase 3 trial in which Tezspire demonstrated superiority across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy.2

“Today’s approval by the FDA marks the first time that patients and their physicians will have a biologic option for severe asthma without phenotypic limitations and irrespective of biomarker levels,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “Asthma is a complex and chronic inflammatory disease that affects everyone differently. By working at the top of the inflammation cascade, Tezspire helps stop the inflammation that causes asthma attacks at the source and has the potential to treat a broad population of people with severe asthma, including those who have historically lacked effective treatment options.”

Tezspire acts at the top of the inflammatory cascade by targeting thymic stromal lymphopoietin (TSLP), an epithelial cytokine.3 It is the first and only biologic to consistently and significantly reduce asthma exacerbations across Phase 2 and 3 clinical trials, which included a broad population of severe asthma patients irrespective of key biomarkers, including blood eosinophil counts, allergic status and fractional exhaled nitric oxide (FeNO).2,3 Tezspire is the first and only biologic for severe asthma that does not have a phenotype—eosinophilic or allergic—or biomarker limitation within its approved label.4-11

“Due to the complex and heterogeneous nature of severe asthma and despite recent advances, many patients continue to experience frequent exacerbations, an increased risk of hospitalization and a significantly reduced quality of life,” said Professor Andrew Menzies-Gow, director of the Lung Division, Royal Brompton Hospital, London, UK, and the principal investigator of the NAVIGATOR trial. “Tezspire represents a much-needed new treatment for the many patients who remain underserved and continue to struggle with severe, uncontrolled asthma.”

Results from the NAVIGATOR Phase 3 trial were published in The New England Journal of Medicine in May 2021.2 In clinical studies of Tezspire, the most common adverse reactions were nasopharyngitis, upper respiratory tract infection and headache.

Specialty pharmacies should be well into forecasting for the upcoming year. Cash in fuels cash out….. and you know that more of the former is critical for growth. So, good forecasting provides a roadmap for marketing, sales, purchasing, HR, etc., to ramp up for the new year — or, heaven forbid, plan to trim expenses. Remember, Finance takes an approved forecast and translates it into a company budget.

All good forecasts rely on published reports from pharmacy market analytic resources. Successful forecasts aggregate as much data as possible from multiple sources. So, before you submit your 2022 forecast check out the 2020 Specialty Trend Report from Pharmaceutical Strategies Group (PSG). 

CLICK HERE to download the PSG Report

By now you should know the highlights. 2020 was a sour year for the economy and its impact to specialty pharmacy should not be overlooked. But, there was some palpable market rebound in 2021…. but we won’t see that data till about April 2022. So, the trends through the downturn are harbingers for the upturn. And, the 2-5-year estimates in the report are credible metrics to moderate your optimism (or pessimism) for 2022. 

The press release below raised eyebrows. At first, we thought that Omnicell had acquired ReCept Specialty Pharmacy. ReCept is a four decades long running specialty provider and has grown to eleven locations mostly in the southern states. But our quick scan of the release proved first impressions wrong.

ReCept has sold off only the assets of a relatively small division, one that provides specialty pharmacy management services for health systems, clinics, and physician groups. Services include operational expertise, HR, technology / integration, workflow management, payer access assistance, and other aspects of managing a specialty pharmacy.

What is noteworthy is that these services are being offered to help health system owned (HOSP) pharmacies compete with independent specialty pharmacies. Is this a case of ‘If ya can’t beat em’… join em’? ReCept would not be the first SP to make this tack. Walgreens, for example, has been active in the HOSP space for several years.

Perhaps the most eye-popping aspect of the announcement was that this division only generated $24 million in the prior year period….. but was acquired by Omnicell for $100 million. That’s not 5X EBIDTA…. It’s 5X Revenue. Well played ReCept….. well played!

ReCept will continue to operate its specialty pharmacies and retail locations. 
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Omnicell to Acquire ReCept

Strategic acquisition of leading specialty pharmacy management services provider supports the Autonomous Pharmacy vision and expands Omnicell’s Advanced Services portfolio

Addresses significant need for access to and management of complex medications, expected to improve profitability and patient care

December 02, 2021  — Mountain View, Calif.–(BUSINESS WIRE)–Omnicell, Inc., a leading provider of medication management solutions and adherence tools for health systems and pharmacies, today announced it has entered into a definitive agreement with ReCept Holdings, Inc., a leading provider of specialty pharmacy management services for health systems, clinics, and physician groups, to acquire its business for total aggregate cash consideration of $100 million, subject to customary adjustments. The acquisition will broaden Omnicell’s portfolio of capabilities and services to address the significant need to improve access to and care coordination for complex medications.

“As medical innovations drive new, more complex drugs, pharmacy requires more specialized tools and expertise to help manage the patient’s treatment journey”

Studies have shown that specialty medications represent over 50 percent of the country’s total spending on retail, mail-order, and provider-administered drugs.1 Used for treatment of complex conditions, these medications often require intensive patient management and specialized workflows for dispensing and care coordination. Specialty pharmacies serve as the connection between patients, prescribing physicians, and payors to ensure streamlined access and adherence to these specialty drugs, helping to maintain continuity of care throughout the process, and are expected to improve margin and profitability. As an Advanced Services organization, ReCept provides implementation and managed services for health systems and other provider organizations to optimize their specialty pharmacy programs and the related pharmaceutical aspects of patient care.

The ReCept acquisition will add solutions for specialty pharmacy management services, including specialty pharmacy expertise and operational capabilities, human resources, technology and integration, workflow management, payor access assistance, and other aspects of managing a specialty pharmacy, to Omnicell’s broader medication management infrastructure. This total solution for provider groups, federally qualified health centers (FQHCs), and health systems supports on-site management of specialty pharmacy services, including payor contracting, staffing, licensing, quality assurance, 340B administration, and preferred pricing agreements designed to improve margin and profitability, while keeping the patient at the center of care.

“As medical innovations drive new, more complex drugs, pharmacy requires more specialized tools and expertise to help manage the patient’s treatment journey,” said Randall Lipps, chairman, president, CEO, and founder of Omnicell. “The ReCept acquisition is a strategic investment that expands our portfolio to address the significant market need for specialty pharmacy solutions. Our entry into this rapidly expanding area of practice is a natural progression on the path to the Autonomous Pharmacy and the goal to enhance care, improve efficiency, and drive profitability. We are excited to add these critical solutions to the Omnicell portfolio for our health system clients and prospects.”

“Specialty pharmacy is a key component of medication management. By joining with Omnicell we look forward to maximizing the benefits of our managed services capabilities as part of a broader, intelligent infrastructure that will deliver value for our pharmacy partners,” said Carmine DeNardo, president and chief executive officer, ReCept. “The synergies with Omnicell’s advanced pharmacy technology solutions create a comprehensive strategic partner that will help give health systems broader and deeper expertise across the full spectrum of medication management.”

Compelling Strategic BenefitsDifferentiated Portfolio of Solutions: ReCept provides a full suite of turnkey specialty pharmacy management services, including specialty pharmacy expertise and operational capabilities, technology and integration solutions, assistance in increasing access to payor networks and limited distribution drugs, and performance analytics and clinical outcomes assessment tools. These capabilities are complementary to Omnicell 340B, EnlivenHealth™, and IV Compounding Services, and can also support health systems moving to a consolidated service center approach to pharmacy operations.

Extends the Autonomous Pharmacy Vision: The ReCept acquisition furthers Omnicell’s commitment to deliver the hardware, software, and services to support the Autonomous Pharmacy vision, while advancing the evolution of the pharmacy care delivery model.

Complementary to Existing Solutions: The combination of ReCept’s specialty pharmacy expertise and operational capabilities and Omnicell’s commercial capabilities and client relationships, as well as its 340B program administration solutions and EnlivenHealth’s patient and member management tools, is expected to provide meaningful differentiation in the large and growing specialty pharmacy managed services organizations.

Transaction HighlightsUnder the terms of the agreement, Omnicell will pay total aggregate cash consideration of $100 million, subject to customary adjustments, at closing as provided for in the agreement and plan of merger. The transaction, which is expected to close by the end of the year, is subject to Hart-Scott-Rodino clearance and the satisfaction of other customary closing conditions. The ReCept business that is being acquired recorded approximately $24 million of total revenue (unaudited) for the 12 months ended September 30, 2021.

Omnicell will use cash available on its balance sheet to fund the transaction. Upon closing, the transaction is expected to be accretive to Omnicell’s non-GAAP EBITDA beginning in the first quarter of 2023.

About ReCeptReCept is the national leader in pharmacy and specialty pharmacy management solutions for health systems, federally qualified health centers, Ryan White HIV/AIDS programs and large physician provider groups. With over 40 years of experience in retail and specialty pharmacy management, ReCept has developed a proprietary and turnkey implementation and management platform, leveraging industry best practices to help pharmacies achieve their full potential. ReCept leads its customers through the entire pharmacy lifecycle, from store buildout to licensing to supporting ongoing operations to ensure future success. As a respected partner in the industry focused on quality patient care since 1978, ReCept helps its customers tackle the barriers associated with specialty medications, increasing patient access, improving patient adherence, and driving better outcomes for patients and prescribers. ReCept is a portfolio company of Generation Partners. To learn more about ReCept, visit: https://receptrx.com.

About OmnicellSince 1992, Omnicell has been committed to transforming the pharmacy care delivery model to dramatically improve outcomes and lower costs. Through the vision of the autonomous pharmacy, a combination of automation, intelligence, and technology-enabled services, powered by a cloud data platform, Omnicell supports more efficient ways to manage medications across all care settings. Over 7,000 facilities worldwide use Omnicell automation and analytics solutions to help increase operational efficiency, reduce medication errors, deliver actionable intelligence, and improve patient safety. More than 60,000 institutional and retail pharmacies across North America and the United Kingdom leverage Omnicell’s innovative medication adherence and population health solutions to improve patient engagement and adherence to prescriptions, helping to reduce costly hospital readmissions. To learn more, visit www.omnicell.com.