Phase 2 Proof-of-Concept Study of NBI-921352 in Patients with Focal Onset Seizures Failed to Demonstrate Meaningful Reduction in Seizure Frequency
Phase 2 Proof-of-Concept Study of NBI-1065846 in Patients with Anhedonia in Major Depressive Disorder Failed to Meet its Primary Endpoint
After its dim third-quarter earnings report on Nov. 2, Moderna (MRNA -2.56%) saw its shares crash by more than 12% before recovering. Still, the stock is down by 60% this year, and it's clear that investors continue to have doubts about prospects for the once-vaunted biotech.
But there's more than one reason to believe Moderna may yet have a bright future ahead, provided that you're willing to hold it over the next few years. Let's examine how its strategic plans and favorable stock valuation might make it a great performer for those with a little patience.
Most people are familiar with Moderna thanks to its coronavirus vaccines. It's going to continue making those jabs, but in case it wasn't obvious, peak sales of those vaccinations are in the past and won't be returning.
The company anticipates residual sales of Spikevax to reach $6 billion in 2023, which likely will fall further to $4 billion in 2024. Compared to its haul in excess of $19 billion last year, that sum isn't much. So far, its prior hopes for the seasonal market for updated booster shots being enough to sustain the top line have not been borne out.
The next driver of fresh revenue will likely be its respiratory syncytial virus (RSV) vaccine for older adults, which it expects to launch in 2024, assuming regulators approve it. Despite its performance characteristics, which management describes as the best in its class, it will have some competition. Pfizer brought in $375 million in the third quarter with its RSV shot, and GSK's version is selling even more. Grabbing market share from those two juggernauts will be difficult, so it is unlikely that the vaccine will have a blowout debut.
Moderna's prospects beyond RSV are even more important to the bull thesis, however. The company's pipeline has as many as 15 new or updated medicines it could commercialize within the next five years. Management has been diligently funneling its coronavirus vaccine windfalls into research and development (R&D) to provision for its future. There should be additional R&D investment of $25 billion between 2024 and 2028.
Among the notable programs set to advance are its combination vaccine for COVID-19, influenza, and RSV, which could easily become a seasonal staple for public health organizations worldwide as a result of its convenience.
In its oncology segment, it also has three vaccines designed to treat cancers like melanoma and non-small cell lung cancer in conjunction with other medicines. And most of its rare-disease portfolio is in early to mid-stage clinical testing right now.
By 2028, Moderna could have a base of strongly recurring sales from its seasonal prophylactic vaccines, as well as significant revenue from its therapeutic vaccines for oncology and a few rare diseases. By then, its top line might not be bigger than it was in 2022, but it could still grow a huge amount from where it is today, beefing up its share price in the process.
Moderna's next couple of years are more likely to be transitional than impressive. It's no surprise that the market is showing its disfavor for the stock. Its shares might yet drop further as it doesn't particularly have anything coming up that would make the market swoon in expectation of massive new revenue. There is also no guarantee that 100% of its ongoing clinical trials will succeed.
But for farsighted investors, the stock is currently at an attractive entry point. Right now, its price-to-sales (P/S) ratio is 2.9. For reference, in the third quarter of 2019, well before its blockbuster coronavirus jab was even on the radar (and in fact before it even had any products on the market), its P/S multiple was 56. At the end of 2020, it was 686.
So it is safe to say that the pandemic-era hype that drove its valuation skyward is now fully deflated. That means the risk of a rapid deflation of its shares is far lower than it was just last year.
If you can stomach the idea of its shares getting even cheaper as the remaining scale-down of its coronavirus revenue plays out through 2024, Moderna stock is a no-brainer buy at the moment. It's rare to find a biotech with a proven development platform, a battle-tested and visionary management team, and a world-class commercial organization. It's even rarer to find such a company priced cheaply. Just don't expect success to arrive overnight.
https://www.fool.com/investing/2023/11/09/modernas-stock-just-tumbled-12-heres-why-its-still/
Indivior PLC on Thursday maintained net revenue guidance, after swinging to a net loss despite seeing a sales increase in the third quarter.
For the three months ended September 30, the Virginia-headquartered pharmaceutical company reported net revenue of USD271 million, up 17% from USD232 million a year prior.
During the third quarter, US revenue rose 20% to USD227 million from USD189 million. Meanwhile, Rest of World revenue grew 2% to USD44 million from USD43 million the previous year.
By contrast, Indivior posted a net loss of USD135 million for the quarter, swung from net income of USD41 million year-on-year. Pretax loss was USD181 million, swung from profit of USD54 million.
Diluted loss per share was USD0.98, swung from earnings per share of USD0.29 a year prior.
Losses came amid higher expenses. While research and development costs were marginally lower year-on-year at USD18 million from USD20 million, selling, general and administrative expenses rose to USD390 million from USD115 million.
Earlier in October, Indivior reached an agreement to resolve claims brought by the direct purchasers in an antitrust multi-district litigation.
The litigation was centred on the claim that the pharmaceutical company stymied generic competition for the opioid addiction treatment Suboxone, in order to preserve its dominance.
Indivior agreed to pay USD385 million and book a charge of USD228 million in the third quarter, though said this would be excluded from adjusted earnings. Payment is expected to be made in November, and funded from existing cash.
"This quarter has again demonstrated the commitment and capabilities of the Indivior team. We delivered double-digit top-line performance led by strong growth of SUBLOCADE (buprenorphine extended release), which continues to shift the paradigm for the treatment of opioid use disorder," said Chief Executive Officer Mark Crossley.
"Additionally, we made good progress against our strategic priorities, with the launch of OPVEE (nalmefene) nasal spray as well as key transactions to strengthen our pipeline and to secure long-term product supply," Crossley added.
Looking ahead, the firm continues to expect full year net revenue in the range of USD1.03 billion to USD1.09 billion, reflecting growth of 18% at the mid-point compared with the previous year.
Within the total, it now expects Sublocade net revenue to be USD610 million to USD630 million, versus the previous range of USD590 million to USD630 million, based on continued strong performance in the OHS channel.
Perseris net revenue is now expected to be at the lower end of the USD45 million to USD55 million guidance range, reflecting year-to-date results and near-term competitive pressures.
Costs are expected to be higher, with selling, general and administrative expenses anticipated between USD540 million and USD550 million, from previous guidance of USD530 million to USD540 million.
Overall, Indivior continues to expect adjusted operating profit to be higher than the previous financial year's USD212 million.
-- VAX-31, a 31-Valent Pneumococcal Conjugate Vaccine (PCV) Candidate, is the Broadest-Spectrum PCV to Enter the Clinic --
-- Topline Safety, Tolerability and Immunogenicity Data Expected in Second Half of 2024 --
-- VAX-31 is Designed to Provide Coverage for Approximately 95% of Invasive Pneumococcal Disease Circulating in the U.S. Adult Population -
Struggling from the slow rollout and lack of demand for its COVID-19 vaccine, Novavax scaled down its full-year guidance Thursday, as total revenue for the third quarter sank 75% compared to the prior year.
Thanks to a boost from $165 million in U.S. government grants to help cover clinical trial expenses, Novavax’s third-quarter revenue was higher than expected at $187 million, down from $735 million in the prior year. An additional $12 million came from royalties.
With sagging sales, Novavax dropped its full-year guidance for 2023 to a range of $900 million to $1.1 billion, down from its previous forecast of $1.3 billion to $1.5 billion.
R&D expenses for the quarter were $106 million, compared to $304 million for the same quarter last year. In the first nine months of the year, it cut $950 million out of its operating expenses. Yet, after warning investors it may not be able to continue operations in March 2023, Novavax is now ready to slash even more from its spending.
The vaccine maker announced it is prepared to initiate an additional cost cutting program to further reduce 2024 expenses by over $300 million. Novavax anticipates slashing annual research and commercial expenses up to 25% through cost-cutting initiatives and layoffs. In May 2023, the company announced it would reduce its workforce by about 25%.
Novavax is suffering from the same disappointing financial results Moderna, Pfizer and BioNTech have reported—a dwindling market for COVID-19 vaccines.
While Novavax’s updated COVID-19 vaccine won regulatory approval last month, the market is significantly smaller this year than anticipated. Experts had estimated 80 million to 100 million doses in the U.S. market this year, but the expectation for COVID shots is now between 30 million to 50 million. As of Oct. 27, only around 4.5% of the U.S. population has received the updated shots now available.
"We are proud of the progress we made over the last quarter to deliver the only protein-based non-mRNA vaccine option in the U.S.,” Novavax CEO John Jacobs said in a statement, clarifying that despite the planned cost reductions, the company will maintain its “ability to bring forward a combination vaccine.”
Novavax and Pfizer are respectively working on combining their COVID shots with protection from seasonal influenza. Expecting to initiate a pivotal trial in the second half of 2024, Novavax is aiming for approval and launch as early as 2026.
Novo Nordisk will discontinue its long-acting insulin treatment Levemir in the U.S. by the end of next year, the company announced Wednesday.
The decision was driven by “global manufacturing constraints, formulary losses impacting patient access, and the availability of alternative options,” Novo said in a posting on its website. “We will continue to provide Levemir FlexPen and Levemir vials to wholesalers while supplies last, up to the discontinuation dates, but supply disruptions should be expected.”
FlexPen supplies will see disruptions starting in mid-January 2024, leading up to the product’s complete discontinuation by April 1, 2024. Levemir vials will continue to be available beyond that until the full brand is discontinued on Dec. 31, 2024.
Levemir’s discontinuation comes amid strong pressure from U.S. lawmakers to lower insulin prices. In March 2023, Sen. Bernie Sanders (I-VT), chairman of the Committee on Health, Education, Labor and Pensions, wrote to Novo and Sanofi urging them to follow Eli Lilly’s example and lower the costs of their insulin products.
Novo agreed a few days later, announcing that it would cut the list prices for several of its insulin products by up to 75%. In its announcement at the time, the company specifically named Levemir, which would take a 65% price cut. Novo also committed to lowering the prices of Novolin and NovoLog, as well as its unbranded biologics to match the reduced costs of the branded reference products. These new prices are set to take effect on Jan. 1, 2024.
Novo is also facing additional pricing pressure from the Inflation Reduction Act’s Drug Price Negotiation Program. In August 2023, the Centers for Medicare and Medicaid Services announced the first 10 drugs that will be impacted by the negotiations.
The CMS list includes Novo’s insulin products Fiasp and NovoLog, alongside other highly prescribed medicines such as Lilly’s Jardiance (empagliflozin) and Amgen’s Enbrel (etancercept). Novo has reluctantly agreed to participate in the drug price negotiations.
Nevertheless, even as Novo faces price reductions on its insulin products, the company is still enjoying strong sales growth, driven mainly by its weight-loss franchise. In its third-quarter financial report, Novo reported that Wegovy (semaglutide) earned almost $3.1 billion in revenue during the first nine months of 2023. This represents approximately 490% sales growth compared to the prior year period.
Demand for Wegovy is expected to grow even stronger, particularly as Novo appears to be eyeing an expansion into renal and cardiovascular spaces. Last month, the company ended the Phase III FLOW trial ahead of schedule due to strong signals of efficacy in kidney outcomes. In August 2023, Novo reported that Wegovy also cleared the Phase III STEP trial in patients with heart failure with preserved ejection fraction.
