Moderna Reports First Quarter 2024 Financial Results and Provides Business Updates

Alleen voor leden beschikbaar, wordt daarom gratis lid!

Algemeen advies 02/05/2024 15:01
Reports rst quarter revenues of $167 million, GAAP net loss of $1.2 billion and GAAP diluted EPS of $(3.07)
Prepares for launches of RSV vaccine and Spikevax® 2024-2025 formula; rearms 2024 expected product sales of
approximately $4 billion
Initiated three new clinical studies evaluating Moderna's investigational individualized neoantigen therapy in
combination with Merck's Keytruda® for treatment of patients with bladder cancer, kidney cancer and cutaneous
squamous cell carcinoma
Advanced three new vaccine programs (Epstein-Barr virus, Varicella-Zoster virus, norovirus) toward Phase 3 clinical
trials as announced at Vaccines Day investor event
CAMBRIDGE, MA / ACCESSWIRE / May 2, 2024 / Moderna, Inc. (NASDAQ:MRNA) today reported nancial results and
provided business updates for the rst quarter of 2024.
"As we anticipate the launches of our Spikevax 2024-2025 formula and RSV vaccine, we are exercising nancial
discipline and have intensied our focus on building and utilizing AI technologies to further streamline operations
and enhance productivity," said Stéphane Bancel, Chief Executive Ocer of Moderna. "With 10 late-stage programs,
and additional new programs advancing toward pivotal studies, we continue to expect numerous product
milestones this year across our vaccines and therapeutics portfolio. This is the start of a banner year for our vaccine
platform as we continue to advance mRNA medicines for patients. This is just the beginning."
1
Recent progress includes:
Commercial Updates
COVID-19: The Company reported $167 million in Spikevax (COVID-19 vaccine) sales in the rst quarter of 2024,
which includes $100 million of U.S. sales and $67 million of international sales.
In the U.S., the Company is rearming its 2024 product sales outlook as it enters the second year of the
commercial endemic COVID market. Moderna's focus is on working with public health ocials, health care
providers and pharmacies to increase vaccination coverage rates to reduce the substantial burden of COVID-19.
Moderna is also working with the U.S. FDA and regulators to align the timing of u and COVID-19 vaccine approvals,
which is expected to result in higher vaccination uptake if vaccines are available sooner and oered at the same
time as the u shot.
In the European Union, Moderna is participating in the EU Health Emergency and Response Authority's tendering
procedure for up to 36 million doses of mRNA COVID-19 vaccines per year for up to four years.
In the Rest of World, the Company is prioritizing markets for greater commercial focus and in April announced a
contract with the Ministry of Health in Brazil (Ministério da Saúde) to supply 12.5 million mRNA COVID-19 vaccines
as an integral part of Brazil's 2024 national vaccination campaign against COVID-19.
RSV: The Company anticipates initial regulatory approvals of its RSV vaccine (mRNA-1345) beginning in the rst half
of 2024.
Moderna is targeting fall 2024 for its U.S. RSV vaccine launch, which will build upon the success of its commercial
eorts in the fall COVID-19 market. The Company is encouraged by early indications of widespread consumer
awareness and established demand in the RSV market, which Moderna will enter with a strong competitive prole
with robust clinical ecacy data, a well-established safety and tolerability prole for its mRNA technology, and as
the only pre-lled syringe (PFS) product available.
The PFS ready-to-use formulation will save pharmacists and clinicians time, potentially alleviating wait times and
reducing the burden on pharmacy sta. In a study funded by Moderna, the PFS presentation was three to four
times more ecient than vaccines requiring reconstitution, measured in doses per hour and based on mean time
of preparation.
First Quarter 2024 Financial Results
2
Revenue: Total revenue for the rst quarter of 2024 was $167 million, compared to $1.9 billion in the same period
in 2023. The decline was primarily due to reduced sales of the Company's COVID-19 vaccine. Net product sales for
the rst quarter of 2024 were $167 million, representing a 91% decline compared to the same period in 2023. This
decline aligns with the anticipated transition to a seasonal COVID-19 vaccine market; in the prior year period, the
Company recognized revenue primarily from delivered doses deferred from 2022.
Cost of Sales: Cost of sales for the rst quarter of 2024 totaled $96 million, which included third-party royalties of $8
million, inventory write-downs of $30 million, and unutilized manufacturing capacity and winddown costs of $27
million. Cost of sales for the rst quarter of 2024 decreased by $696 million, or 88%, compared to the same period
in 2023. Cost of sales as a percentage of net product sales was 58% for the rst quarter of 2024, compared to 43%
for the rst quarter of 2023. The decrease in cost of sales in 2024 was primarily driven by lower sales volume
coupled with reduced unutilized manufacturing capacity, inventory write-downs and losses on rm purchase
commitments and related cancellation fees. Conversely, the increase in cost of sales as a percentage of net product
sales in 2024 was driven by the lower sales level compared to the prior year.
Research and Development Expenses: Research and development expenses for the rst quarter of 2024 decreased
by 6% to $1.1 billion, compared to the same quarter of 2023. This reduction was primarily due to the absence of
upfront collaboration payments being made in 2024. The upfront payments made in the rst quarter of 2023 were
related to the Company's strategic collaborations with Generation Bio and Life Edit Therapeutics. Additionally, there
was a decrease in clinical development and manufacturing expenses, driven by lower spending on clinical trials for
the Company's COVID-19, RSV and seasonal u programs, which aligns with its planned trial schedules. These
decreases were partially oset by higher personnel-related costs, resulting from an increased headcount in the
research and development functions.
Selling, General and Administrative Expenses: Selling, general and administrative expenses for the rst quarter of
2024 decreased by 10% to $274 million, compared to the rst quarter of 2023. This decrease is a result of cost
discipline and the eciencies resulting from investments the Company made in foundational capabilities over the
last year, which allowed for a signicant reduction of purchased services and the use of external consultants. The
Company continues to invest in digital and commercial capabilities and has intensied its focus on building and
utilizing AI technologies to further streamline operations and enhance productivity.
Income Taxes: Income tax expense for the rst quarter of 2024 was $10 million, in contrast to an income tax benet
of $384 million in the same period last year. The shift primarily resulted from the continued application of a
valuation allowance on the majority of the Company's deferred tax assets, rst established in the third quarter of
2023. The Company only maintained a valuation allowance on certain state deferred tax assets prior to the third quarter of 2023.

see & read more on
https://s29.q4cdn.com/435878511/files/doc_news/Moderna-Reports-First-Quarter-2024-Financial-Results-and-Provides-Business-Updates-2024.pdf



Beperkte weergave !
Leden hebben toegang tot meer informatie! Omdat u nog geen lid bent of niet staat ingelogd, ziet u nu een beperktere pagina. Wordt daarom GRATIS Lid of login met uw wachtwoord


Copyrights © 2000 by XEA.nl all rights reserved
Niets mag zonder toestemming van de redactie worden gekopieerd, linken naar deze pagina is wel toegestaan.


Copyrights © DEBELEGGERSADVISEUR.NL