It took Bristol Myers Squibb’s new CEO Chris Boerner 16 minutes into his 24-minute presentation to address the big news the company made last month, with its holiday buyouts of Karuna Therapeutics, for $14 billion, and RayzeBio, for $4.1 billion.
What Boerner most wanted to highlight was the company’s pipeline which he said could deliver more than 16 new products through 2030.
“These products are overwhelmingly first- or best-in-class,” Boerner said. “And it is the pipeline momentum that supports the growth opportunities that we see in the back half of the decade.”
That period will be crunch time for BMS as it bears the brunt of patent expirations and Inflation Reduction Act effects for its trio of blockbuster drugs Revlimid, Eliquis and Opdivo, which accounted for 65% of the company’s revenue in 2022.
“While we have entered another significant period of transition for the company, I am very confident in our ability to navigate this journey with the goal of achieving top-tier growth by the end of the decade.”
Neuroscience specialist Karuna brings KarXT, which is set up for approval later this year, “has the potential to transform the treatment of schizophrenia and has a number of subsequent indications with significant, we believe, multi-billion dollar potential,” Boerner said. Meanwhile, RayzeBio provides earlier-stage radiopharma assets that could blossom later.
When asked about the potential to make other such deals, the BMS CEO said the company’s first priority is to “deliver on our organic pipeline,” Borner said. “I don’t think our pipeline has ever been richer.”
With those big-money deals done, Boerner added that BMS’s focus on business development will be on “licensing opportunities, partnerships and bolt-on opportunities.”
As for the more immediate future, Boerner sounded optimistic about the supply problems the company has experienced with CAR-T treatment Breyanzi, saying he feels "very good" about the expanded production capacity the company has secured.
"We've got to make sure we've got that capacity but more importantly, we've got two new indications with follicular lymphoma and (chronic lymphocytic leukemia)," Boerner said about Breyanzi.
Boerner also touted the improvements BMS has made in supplying another cell therapy, Abecma.
– Second and third FDA Fast Track Designations for CABA-201, following the systemic lupus erythematosus (SLE) and lupus nephritis (LN) designation, providing the opportunity for expedited development and review of CABA-201 for the treatment of these autoimmune diseases –
One of the most widely-used asthma and breathing treatments for over 20 years is being taken off the shelves in 2024, potentially leaving patients, healthcare providers and insurers scrambling.
Pharmaceutical manufacturer GlaxoSmithKline (GSK) announced that as of Jan. 1 it would no longer produce the asthma inhaler Flovent, one of the most popular preventive and maintenance treatments for asthma and pediatric asthma for decades.
The company will instead produce authorized generic versions of the inhalers, which it said will look and work the same but will simply not be branded with the Flovent name.
While GSK said the decision was made to offer a "potentially lower cost alternative" to patients who rely on the medication, experts have raised some concerns regarding the switch, including lower rates of insurance coverage, supply and prescription disruptions and pharmacy delays.
Doctors are suggesting people currently undergoing asthma treatment prepare for the switch and any potential hiccups, as it is important to maintain care with minimal interruption. Here's what we know about the switch so far.
GSK discontinues Flovent
In an email statement to USA TODAY, GSK said the company had launched the authorized generics of Flovent products in May 2022 and Oct. 2023 in conjunction with Prasco but are making the switch to utilizing only these generics starting Jan. 1, 2024.
"GSK will discontinue manufacturing branded Flovent HFA (all strengths) and branded Flovent Diskus (all strengths) for the US market," the pharmaceutical company said, as the generic alternatives work the same for a potentially lower cost. According to GSK, the non-name brand medications come in the same style of packaging with the same dosages and instructions as Flovent-branded products.
"These authorized generics will provide patients in the US with potentially lower cost alternatives of these medically important products," said GSK, and the change is the result of a commitment "to ensuring the affordability of our medicines."
While GSK has said the generics "may potentially be a lower-cost alternative to patients, depending on their insurance coverage and benefit design," reports have pointed out that the switch happened as a new provision to the 2021 American Rescue Plan Act came into play, which removes the cap on how much companies pay in rebates to Medicare if they have raised the prices of medications at a rate surpassing inflammation.
Past price hikes at a rate of almost 50% since 2014 may have left Flovent vulnerable to these Medicare costs, but a "new" medication without a history of such changes would not be. According to Good RX data, the Flovent HFA inhaler 110mcg ran $337.77 per package on Dec. 1, 2023, and the Flovent diskus inhaler 100mcg cost $264.26.
According to CNN, the new authorized generic of Flovent HFA is set at $177.99, a markedly cheaper price on paper.
"It's important to keep in mind that the list price is not the price most people usually pay as it does not include discounts, rebates, and other price adjustments to wholesalers or any other customer," GSK likewise said.
However, the change poses a different kind of affordability problem: availability through insurance.
Melanie Carver, Chief Mission Officer of the Asthma and Allergy Foundation of America (AAFA), told USA TODAY that access to the authorized generic will depend on a person’s health insurance and pharmacy benefits.
"While we hope most plans will replace the brand name Flovent with the authorized generic – we will have to wait and see if that doesn’t happen and causes challenges for patients to get the medicine they need," she said. "For some people, the out-of-pocket costs may unexpectedly be higher with the generic if their plan doesn’t have the authorized generics on their preferred drug lists."
Carver advised that the inhalers and the medicine inside them, fluticasone, will remain the same after the branding change. Disruptions in treatment may still occur due to pharmacy and insurance delays, however. She also clarified that there are no direct substitutes for the fluticasone HFA and fluticasone diskus other than the authorized generics, as other inhalers may have different medicines, uses or doses.
"It is really important for people with asthma to continue their asthma control medicines, especially during respiratory illness season," said Carver. "Fluticasone works by controlling inflammation and swelling in the airways to prevent asthma attacks. Pharmacy delays can put a person with asthma at risk of worsening inflammation. It’s a good idea to check your insurance now to see if the authorized generic fluticasone will be covered by your plan."
Some major insurers and pharmacies err toward keeping name-brand medications such as ArmonAir Digihaler and Arnuity Ellipta on their preferred drug lists, meaning GSK's ostensibly lower-cost generic may no longer be available to patients. In some cases, this will simply mean speaking to your pharmacist to be re-trained on how to use a different brand or type of inhaler or treatment.
In some other cases, however, finding and using an alternative is not that simple.
"Although Flovent is an asthma medication, the HFA version (metered dose inhaler) is also used off-label for the treatment of eosinophilic esophagitis (EoE), a chronic allergic inflammatory condition in the esophagus," said Carver.
It is the standard of care and most common treatment for children with EoE, she said and works by being sprayed via the inhaler into the mouth and the aerosolized fluticasone then being swallowed. However, some insurers do not offer a proper alternative for this treatment.
"Some insurers are transitioning to breath-actuated inhalers (like the diskus versions) on their preferred drug lists, but these are not appropriate for the treatment of EoE," she said.
What should you do if you or a loved one rely on Flovent? Get in touch with your doctor and insurers ahead of time, get that refill done ASAP and establish a clear path forward for ongoing treatment after the switch.
"If your insurance plan will not cover the authorized generic fluticasone, there are other inhaler options for the treatment of asthma," said Carver. "Check with your doctor on what dose to take if you are prescribed this medicine and ask them to show you how to use these inhalers."
Refill your current Flovent prescription as soon as possible.
Talk with your doctor about other asthma medicines. Some brand name options may include ArmonAir Digihaler and Arnuity Ellipta.
ArmonAir Digihaler is an alternative for Flovent Diskus. The formulation is the same but have slightly different doses available.
Arnuity Ellipta is an inhaled steroid but not a direct substitute for Flovent HFA or Flovent Diskus. Check with your doctor on what dose to take if you are prescribed this medicine.
Consider an authorized generic.
A generic fluticasone metered dose inhaler is available by RPK pharmaceuticals with the same doses as Flovent HFA.
Check with your insurance to find out what other asthma medicines they cover.
Preliminary unaudited revenue of approximately $6.8 million, a 32% year-over-year increase;
Increased biologics and drug delivery revenue to approximately $4.1 million, a 76% year-over-year increase; and
Cash burn of approximately $1.2 million in the fourth quarter. The Company had approximately $23.1 million in cash and cash equivalents at December 31, 2023.
Full Year 2023 Preliminary Unaudited Financial Highlights
Achieved preliminary unaudited record revenue of approximately $24 million, a 17% year-over-year increase, versus most recent guidance of $23 - $25 million; and
Increased biologics and drug delivery revenue to approximately $13.6 million, a 49% year-over-year increase.
Business Outlook and Planned Value Creating Milestones
The Company estimates revenue in 2024 to be between $28 million and $32 million, representing growth between 17% and 33%;
Achieve FDA clearance and launch SmartFrame OR for navigation and first revenue in the operating room;
Launch full market release of the ClearPoint PRISM® Neuro Laser Therapy System;
Launch and deploy ClearPoint 2.2 Software with embedded ClearPoint Maestro® and 1.2 Array Software with parallel trajectory tumor planning application to the installed base;
Win first purchase orders for GLP ready pre-clinical services;
Prototype demonstration of next generation software application for AI predictive modeling to pharma partners;
Continue global expansion to achieve 100 ClearPoint sites by 2025; and
Demonstrate operating leverage with expenses increasing less than revenue growth.
“We are thrilled with our fourth quarter performance delivering record revenue of $6.8 million, reflecting 32% growth, while meaningfully reducing our cash burn and gaining commitments for multiple new ClearPoint installations,” commented Joe Burnett, President and CEO at ClearPoint Neuro.
“In 2024, we look forward to several new product introductions reflecting success with the strategic investments we have made to expand our leadership position, including the SmartFrame OR for our entrance into the operating room; the full market release of the PRISM laser therapy system; the integration of ClearPoint Maestro into our navigation software; and the expansion of our pre-clinical biologics and drug delivery services including GLP readiness. These represent four new potential revenue streams that we plan to add to our base business throughout the year.”
Management will be available for meetings in San Francisco during the J.P. Morgan Healthcare Conference from January 8-11, 2024.
Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, announced today that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate NUV-1511, the first clinical candidate from the company’s novel drug-drug conjugate (DDC) platform.
"This IND clearance expands our clinical pipeline and validates the approach of our proprietary DDC platform to design potent oncology-focused chimeric small molecules which combine tumor-targeting specificity with the anti-cancer activity of known oncology agents," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "We believe NUV-1511 has the potential to provide favorable clinical benefit for patients with various solid tumors and we look forward to initiating the Phase 1/2 study."
Fourth quarter 2023 total revenue is expected to be in the range of $18.6 million to $18.8 million, a decrease of 9% compared to the prior year period at the estimated midpoint.
Surgical Glaucoma revenues are expected to be in the range of $17.1 million to $17.2 million, a decrease of 9% compared to the prior year period at the estimated midpoint.
Dry Eye revenues are expected to be in the range of $1.5 million to $1.6 million, a decrease of 13% compared to the prior year period at the estimated midpoint.
Full year 2023 total revenue is expected to be in the range of $80.9 million to $81.1 million, an increase of 14% compared to the prior year at the estimated midpoint.
Surgical Glaucoma revenues are expected to be in the range of $74.3 million to $74.4 million, an increase of 13% compared to the prior year at the estimated midpoint.
Dry Eye revenues are expected to be in the range of $6.6 million to $6.7 million, an increase of 17% compared to the prior year at the estimated midpoint.
The Company’s cash and cash equivalents as of December 31, 2023, was approximately $138 million, compared to $144.5 million as of September 30, 2023. Cash used in the quarter totaled approximately $6.5 million, reflecting continued operational discipline and a sequential improvement from $10.0 million cash used in the third quarter of 2023 and a decrease versus the comparative period in the prior year where cash used in the fourth quarter of 2022 was $14.8 million.
The Company’s fourth quarter and full year 2023 financial results are preliminary and subject to the completion of the Company’s 2023 audit. The Company expects to announce complete fourth quarter and full year 2023 financial results in March 2024.
"We are pleased to see the resilience exhibited in our fourth quarter sales and the double-digit revenue growth achieved for full year 2023 amidst the significant reimbursement uncertainty in our Surgical Glaucoma segment. We believe this is a testament to the differentiated clinical efficacy of the comprehensive outflow procedure performed with our OMNI® Surgical System technology, the high number of glaucoma surgeons who have mastered the OMNI procedure and made it an essential component of their glaucoma treatment paradigm, and our exceptional team and their incredibly valuable relationships with esteemed ophthalmologists across the country. We were successful in reducing our cost structure and optimizing our commercial teams organizationally to enhance effectiveness, maintain flexibility in prioritizing our strategic objectives, and extend our cash runway in a more dynamic operating environment," said Paul Badawi, Co-Founder and Chief Executive Officer of Sight Sciences. "We were very happy to see the withdrawal of the local coverage determinations from five Medicare Administrative Contractors, “MACs”, (WPS Government Health Administrators, Palmetto GBA, Celerian Group Company, National Government Services, and Noridian Healthcare Solutions), allowing for continued access to our surgical glaucoma technologies for all Medicare beneficiaries. We look forward to continuing to engage with all of the MACs, CMS, and the national and state societies going forward to ensure glaucoma patients and their physicians maintain appropriate and fair access to medically reasonable and necessary MIGS procedures and technologies."
MDxHealth SA (NASDAQ: MDXH), a commercial-stage precision diagnostics company, today reported preliminary fourth quarter and full year 2023 revenues and issued 2024 revenue guidance. The Company expects to report fourth quarter and full year 2023 revenues of approximately $19.4 and $70.2 million, respectively, with a year-end cash balance of $22.4 million, which reflects $2.3 million of non-operating and non-recurring cash use in the fourth quarter, primarily attributed to the transition to a sole listing on NASDAQ. The Company is also issuing 2024 revenue guidance of $79-81 million and confirms view of adjusted EBITDA profitability in first half of 2025.
Michael K. McGarrity, CEO of mdxhealth, commented: “We are pleased to report continued execution on our growth strategy, with year-over-year revenue growth of approximately 89% (or 42% when excluding GPS). We are confident that the strength of our sales channel coupled with our expanded menu offering to our urology customer base will continue to drive sustainable growth. Based on our commitment to continued operating discipline and commercial execution, we anticipate 2024 revenue of $79-81 million, which would represent year-over-year revenue growth of approximately 13-15%.”
