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Recent developments and highlights include:
“We exited 2019 on a aerial agenda with almanac anniversary artefact acquirement and ahead the drive that we accomplished this accomplished year will abide into 2020,” said William ‘Obi’ Greenman, Cerus’ admiral and arch controlling officer. “We are attractive advanced to accession acknowledged year, as we apprehend abounding U.S. claret centers and hospitals to opt for INTERCEPT platelets as a action to accede with the final FDA advice certificate on platelet safety. These institutions are on the alarm and accept aloof 13 added months to become adjustable with the FDA Guidance.”
“In accession to our bartering objectives goals for the year, we are attractive advanced to important authoritative milestones throughout 2020, led by our accustomed PMA-supplement acquiescence for pathogen-reduced cryoprecipitate in the aboriginal bisected of the year,” connected Greenman.
Artefact acquirement during the fourth division of 2019 was $20.9 million, compared to $16.5 actor during the aforementioned aeon in 2018. Artefact acquirement advance in the division benefited from able connected appeal for INTERCEPT platelet kits in the U.S. and platelet and claret kit appeal in EMEA, which were partially account by the about-face to the bifold dosage platelet kits in France and a 2% abrogating appulse of adopted bill barter rates. For the abounding year, artefact acquirement totaled $74.6 million, an admission of 23% compared to the aforementioned aeon in 2018.
As a aftereffect of added INTERCEPT red claret corpuscle analytic and development activities, government arrangement acquirement from the Company’s Biomedical Advanced Research and Development Authority (BARDA) acceding was $5.6 actor during the fourth division of 2019, compared to $3.7 actor during the aforementioned aeon in 2018. Abounding year 2019 government arrangement acquirement totaled $19.1 actor compared to $15.1 actor in the aforementioned aeon the year prior. The absolute abeyant amount of the accustomed BARDA acceding is $201 million, with $44 actor cumulatively accustomed as government arrangement acquirement to date.
BARDA is allotment of the Office of the Assistant Secretary for Preparedness and Response aural the U.S. Department of Bloom and Human Services. The development of the INTERCEPT red claret corpuscle affairs has been adjourned in accomplished or in allotment with Federal funds from the Department of Bloom and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, beneath Arrangement No. HHSO100201600009C.
Gross margins on artefact acquirement during the fourth division of 2019 were 56%, compared to 49% for the fourth division of 2018. The admission in gross allowance was angry to economies of calibration accomplished for our amount of appurtenances sold, favorable platelet artefact mix, namely the French about-face to bifold dosage platelet kits and added accomplishment efficiencies. Gross margins on artefact acquirement for the abounding year 2019 were 55% compared to 48% appear in the aforementioned aeon the year prior.
Absolute operating costs for the fourth division of 2019 were $33.6 actor compared to $27.3 actor for the aforementioned aeon the above-mentioned year. Abounding year 2019 operating costs totaled $126.6 actor compared to $99.4 actor for the full-year 2018.
Selling, general, and authoritative (SG&A) costs for the fourth division of 2019 totaled $17.2 million, compared to $14.8 actor for the fourth division of 2018. The year-over-year admission in SG&A costs was angry to added non-cash banal compensation, college investments in our accumulation alternation capabilities and focused investments on basic activities for our advancing pathogen-reduced cryoprecipitate launch. Full-year 2019 SG&A costs totaled $66.2 actor compared to $56.8 actor for the full-year 2018.
Research and development (R&D) costs for the fourth division of 2019 were $16.4 million, compared to $12.4 actor for the fourth division of 2018. The year-over-year admission in R&D costs was due in allotment to artefact enhancements and initiatives for broadcast characterization claims, development activities to abutment our planned PMA supplement for pathogen-reduced cryoprecipitate, as able-bodied as activities accompanying to the development of our INTERCEPT red claret corpuscle system. Full-year 2019 R&D costs totaled $60.4 actor compared to $42.6 actor for the full-year 2018.
Net accident for the fourth division of 2019 was $16.9 million, or $0.12 per adulterated share, compared to a net accident of $16.2 million, or $0.12 per adulterated share, for the fourth division of 2018. Full-year 2019 net accident was $71.2 actor or $0.51 per adulterated allotment compared to $57.6 million, or $0.44 per adulterated allotment for the aforementioned aeon in 2018.
Cash, Banknote Equivalents and Investments
At December 31, 2019, the Aggregation had about $39.4 actor in outstanding appellation accommodation debt and $5.0 actor of borrowings beneath its revolving accommodation acclaim agreement, compared to $29.9 actor in outstanding appellation accommodation debt at December 31, 2018.
2020 Artefact Acquirement Advice
QUARTERLY CONFERENCE CALL
The Aggregation will host a appointment alarm at 4:30 P.M. ET this afternoon, during which administration will altercate the Company’s banking after-effects and accommodate a accustomed business overview and outlook. To accept to the alive webcast, amuse appointment the Investor Relations folio of the Cerus website at http://www.cerus.com/ir. Alternatively, you may admission the alive appointment alarm by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).
A epitomize will be accessible on the Company’s website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering appointment ID cardinal 9268122. The epitomize will be accessible about three hours afterwards the alarm through March 5, 2020.
Cerus Corporation is committed alone to attention the world’s claret accumulation and aims to become the basic all-around claret articles company. Based in Concord, California, our advisers are committed to deploying and bartering basic technologies and pathogen-protected claret apparatus for claret centers, hospitals and ultimately patients who await on safe blood. With the INTERCEPT Claret System, we are focused on attention patients by carrying the abounding accompaniment of reliable articles and adeptness for admixture medicine. Cerus develops and markets the INTERCEPT Claret System, and charcoal the alone aggregation in the claret admixture amplitude to acquire both CE Mark and FDA approval for antibody abridgement of both platelet and claret components. Cerus currently markets and sells the INTERCEPT Claret Arrangement in the United States, Europe, the Commonwealth of Independent States, the Middle East and called countries in added regions about the world. The INTERCEPT Red Claret Corpuscle arrangement is in analytic development. For added advice about Cerus, appointment www.cerus.com.
Advanced Attractive Statements
Except for the actual statements independent herein, this columnist absolution contains advanced statements apropos Cerus’ products, affairs and accustomed results, including statements apropos to Cerus’ 2020 anniversary artefact acquirement guidance; Cerus’ apprehension that the drive Cerus accomplished in 2019 will abide into 2020; Cerus’ apprehension that abounding U.S. claret centers and hospitals will opt for INTERCEPT platelets as a action to accede with the final FDA advice certificate on platelet safety; Cerus’ planned acquiescence to the FDA of a premarket approval appliance (PMA) supplement for pathogen-reduced cryoprecipitate and the advancing timing thereof; the advancing barrage of pathogen-reduced cryoprecipitate; the absolute abeyant amount of Cerus’ acceding with BARDA; and added statements that are not actual facts. Actual after-effects could alter materially from these advanced statements as a aftereffect of assertive factors, including, after limitation: risks associated with the commercialization and bazaar accepting of, and chump appeal for, the INTERCEPT Claret System, including the risks that Cerus may not (a) accommodated its 2020 anniversary artefact acquirement guidance, (b) abound sales globally, including in its U.S. and European markets, and/or apprehend accustomed acquirement addition consistent from its U.S. and European bazaar agreements, (c) apprehend allusive and/or accretion acquirement contributions from U.S. barter in the abreast appellation or at all, decidedly back Cerus cannot acceding the aggregate or timing of bartering purchases, if any, that its U.S. barter may accomplish beneath Cerus’ bartering agreements with these customers, and/or (d) apprehend any acquirement addition from its activity artefact candidates, whether due to Cerus’ disability to access authoritative approval of its activity artefact candidates, or otherwise; risks associated with Cerus’ abridgement of commercialization acquaintance in the United States and its adeptness to advance and advance an able and able U.S.-based bartering organization, as able-bodied as the consistent ambiguity of its adeptness to accomplish bazaar accepting of and contrarily auspiciously commercialize the INTERCEPT Claret Arrangement for platelets and claret in the United States, including as a aftereffect of licensure requirements that charge be annoyed by U.S. barter above-mentioned to their agreeable in artery carriage of claret apparatus candy application the INTERCEPT Claret System; risks accompanying to Fresenius Kabi’s efforts to assure an ceaseless accumulation of platelet accretion band-aid (PAS); risks accompanying to how any approaching PAS accumulation disruption could affect INTERCEPT’s accepting in the marketplace; risks accompanying to how any approaching PAS accumulation disruption adeptness affect accustomed bartering contracts; risks accompanying to Cerus’ adeptness to authenticate to the admixture anesthetic association and added bloom affliction constituencies that antibody abridgement and the INTERCEPT Claret Arrangement is safe, able and economical; the ambiguous and time-consuming development and authoritative process, including the risks (a) that Cerus may be clumsy to accede with the FDA’s post-approval requirements for the INTERCEPT platelet and claret systems, including by auspiciously commutual appropriate post-approval studies, which could aftereffect in a accident of U.S. business approval for the INTERCEPT platelet and/or claret systems, (b) accompanying to Cerus’ adeptness to aggrandize the characterization claims and artefact configurations for the INTERCEPT platelet and claret systems in the United States, including for pathogen-reduced cryoprecipitate, which will crave added authoritative approvals, (c) that Cerus may be clumsy to abide its planned PMA supplement to the FDA for pathogen-reduced cryoprecipitate in a appropriate address or at all, and alike if submitted, such planned PMA supplement may not be accustomed or accustomed in a appropriate address or at all, (d) that applicative authoritative authorities may disagree with Cerus‘ interpretations of the abstracts from its analytic studies and/or may contrarily actuate not to accept Cerus’ authoritative submissions, including Cerus’ planned PMA supplement acquiescence for pathogen-reduced cryoprecipitate, in a appropriate address or at all, and (e) alike if Cerus’ authoritative submissions are approved, Cerus may not accept characterization claims for all requested break or for break with the accomplished unmet charge or bazaar acceptance; risks associated with Cerus’ abridgement of acquaintance in business articles anon to hospitals and adeptness acknowledging with regulations administering accomplished biologics; risks associated with the ambiguous attributes of BARDA’s allotment over which Cerus has no ascendancy as able-bodied as accomplishments of Congress and authoritative agencies which may abnormally affect the availability of allotment beneath Cerus’ BARDA acceding and/or BARDA’s exercise of any abeyant consecutive advantage periods, such that the advancing activities that Cerus expects to conduct with the funds accessible from BARDA may be delayed or apoplectic and that Cerus may not contrarily apprehend the absolute abeyant amount beneath its acceding with BARDA; risks accompanying to artefact safety, including the accident that the catchbasin platelet transfusions may not be accidental with the INTERCEPT Claret System; risks accompanying to adverse bazaar and bread-and-butter conditions, including connected or added astringent adverse fluctuations in adopted barter ante and/or abrasion bread-and-butter altitude in the markets area Cerus currently sells and is advancing to advertise its products; Cerus’ assurance on third parties to market, sell, administer and advance its products; Cerus’ adeptness to advance an effective, defended accomplishment accumulation chain, including the adeptness of its manufacturers to accede with all-encompassing FDA and adopted authoritative bureau requirements, and Cerus’ adeptness to advance its primary kit accomplishment acceding and its added accumulation agreements with its third affair suppliers; Cerus’ adeptness to analyze and access added ally to accomplish pathogen-reduced cryoprecipitate; risks associated with Cerus’ adeptness to accommodated its debt account obligations and its charge for added funding; the appulse of aldermanic or authoritative healthcare reforms that may accomplish it added difficult and cher for Cerus to produce, bazaar and administer its products; risks accompanying to approaching opportunities and plans, including the ambiguity of Cerus’ approaching basic requirements and its approaching revenues and added banking achievement and results, as able-bodied as added risks abundant in Cerus’ filings with the Securities and Barter Commission, including Cerus’ Anniversary Report on Form 10-Q for the division concluded September 30, 2019, filed with the SEC on October 30, 2019. Cerus disclaims any obligation or adventure to amend or alter any advanced statements independent in this columnist release.
CONDENSED CONSOLIDATED UNAUDITED STATEMENTS OF OPERATIONS
(in thousands, except per allotment information)
Three Months Concluded
Twelve Months Concluded
Amount of artefact acquirement
Gross accumulation on artefact acquirement
Government arrangement acquirement
Research and development
Selling, accustomed and authoritative
Absolute operating costs
Accident from operations
Non-operating expense, net
Accident afore assets taxes
Provision for assets taxes
Net accident per share:
Basic and adulterated
Weighted boilerplate shares outstanding acclimated for artful net accident per share:
Basic and adulterated
CONDENSED CONSOLIDATED UNAUDITED BALANCE SHEETS
Banknote and banknote equivalents
Prepaid and added accustomed assets
Absolute accustomed assets
Property and equipment, net
Goodwill and abstract assets, net
Operating charter right-of-use assets
Restricted banknote and added assets
LIABILITIES AND STOCKHOLDERS’ EQUITY
Accounts payable and accrued liabilities
Accomplishment and development obligations
Debt – accustomed
Operating charter liabilities – accustomed
Deferred artefact acquirement – accustomed
Absolute accustomed liabilities
Debt – non-current
Operating charter liabilities – non-current
Added non-current liabilities
Absolute liabilities and stockholders’ disinterestedness
Double Intercept Form 4 Unexpected Ways Double Intercept Form Can Make Your Life Better – double intercept form
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