[Ip-health] Moderna, May 18, 2020 prospectus filed with SEC
james.love at keionline.org
Thu May 21 04:27:07 PDT 2020
For those following vaccines, this was filed by Moderna a few days ago.
PROSPECTUS Filed pursuant to Rule 424(b)(5) Registration No. 333-238467
Prospectus dated May 18, 2020.
In April, BARDA committed to fund up to $483 million to accelerate the
clinical development and manufacturing process scale-up of mRNA-1273. Under
the terms of the agreement, BARDA will fund the advancement of mRNA-1273 to
FDA licensure and the scale-up of manufacturing processes. The agreement
does not contemplate any product stockpiling.
We expect to utilize the proceeds of this offering to fund working capital
needs to begin manufacturing the vaccine ahead of a potential approval and
launch of mRNA-1273. We believe the substantial majority of these
investments will be used for raw material purchases and other operating
expenses in connection with our mRNA-1273 program, which may result in up
to approximately $1 billion of incremental investments in 2020.
As part of our preparation for wider-scale clinical development,
manufacturing and distribution of mRNA-1273, if approved by the FDA, other
global regulatory authorities or as otherwise authorized for interim
emergency use, we intend to enter into a variety of potential contractual
arrangements and collaborations with third parties. For example, on May 1,
2020, we entered into a ten year strategic collaboration agreement with
Lonza Ltd. to enable larger scale manufacture of mRNA-1273 and additional
Moderna products in the future. Under the terms of the agreement, we plan
to establish manufacturing suites at Lonza’s facilities in the United
States and Switzerland for the manufacture of mRNA-1273 at both sites.
Although the proceeds from this offering will help provide capital to fund
our preparation activities, we continue to seek to collaborate with third
parties in various ways, including through: (i) the entry into contracts
for purchases of raw materials and consumable supplies, including those
that contain provisions requiring exclusivity and contractual obligations
to purchase a certain amount of material in a given period; (ii) contracts
with governmental entities that contain provisions regarding future supply
of an approved vaccine in exchange for payments, some of which may be made
in advance of delivery, that will allow us to utilize such payments to
further build out our manufacturing infrastructure and acquire raw
materials; and (iii) contracts with one or more strategic collaborators
that may assist in some or all of the development, manufacture,
distribution, or storage of a vaccine in one or more jurisdictions. In
addition, one or more of these contracts may be accompanied by an equity
investment in or loan to us, which investment or loan may be used in the
further development of mRNA-1273.
We remain focused on securing additional funding to continue preparation
for larger scale vaccine manufacturing and distribution. This additional
funding will help enable us to purchase the required capital equipment,
hire appropriate global staff and secure the raw materials and other
consumables necessary to produce up to one billion doses of mRNA-1273,
assuming a 50 µg dose. We believe we are positioned to have the first or
one of the first approved vaccines for COVID-19, which will give us an
opportunity to have a global health impact.
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