text:
Nuclear Regulatory Commission Public Meeting – Response to Fukushima Daiichi Events
March 21, 2011 By Rod Adams
***MEDIA ADVISORY*** NUCLEAR REGULATORY COMMISSION TO HOLD PUBLIC MEETING ON NRC RESPONSE TO RECENT JAPAN EVENT
The U.S. Nuclear Regulatory Commission will be briefed by its staff on the NRC's response to the ongoing nuclear event in Japan in a public meeting on March 21 at 9 a.m. at NRC Headquarters, 11555 Rockville Pike, Rockville, Md. The commission meeting will be open to public observation and will be webcast at: http://www.nrc.gov/public-involve/public-meetings/webcast-live.html.
Due to limited space availability, the meeting will be set up for a C-SPAN pool camera crew. Broadcast media outlets interested in receiving the feed should contact the network pool at 202-626-7966. For still photographers, this meeting will be pooled with AP, Reuters, AFP, Bloomberg and Getty.
In order for us to try to ensure sufficient seating for reporters, please notify the Office of Public Affairs at the contact information above if you plan to attend. There will be additional space available in our auditorium on a first-come, first-serve basis.
Pool photographers will have limited space at the meeting in which to take photos. Movement must be kept to a minimum so as not to be distracting and entry into the inner well closest to the Commission briefing table is prohibited. Plan to arrive in advance of the meeting at the Marinelli Road entrance of the NRC with proper media credentials. The NRC offices are located across the street from the White Flint Metro station. Parking is available at the White Flint metro parking garage on Marinelli Road.
If I could attend the above event, I would ask how anyone who understands radiation, radioactive material, doses, dose rates, and contamination could consider an evacuation order to be a conservative approach focused on protecting the public. Putting large populations in motion is always a decision that carries significant potential for causing public harm; that is especially true in the middle of a widespread natural disaster that has strained transportation networks and the logistics support needed to provide food, water and gasoline to the people who have been ordered to move.
However, it is time for me to go back to my day job. You might notice a bit less responsiveness at Atomic Insights compared to what I have managed during the past 10 days; I used up 4.5 days worth of vacation time to do what I think still needs to be done. People need access to more accurate sources of information about the hazards of nuclear energy especially compared to the hazards of all other energy options.
Separate topic – Nuclear Exceptionalism
News flash – the Chiba refinery fire has been reported to have been extinguished as of 0342 EDT on March 21, 2011. That fire was initiated by the March 11, 2011 earthquake. That refinery is about 10-20 miles outside of Tokyo. It dumped thousands of tons of potential hazardous material into the atmosphere in Japan every day for ten solid days. The people who own that refinery could not approach the fire close enough to take effective action due to the high levels of radiation (thermal) being emitted from the fire. My guess is that the fire's fuel finally ran out.
You might recognize some of the footage in the above video. Similar scenes were run several times in the background as the anchors at major news outlets including CNN and CBS talked about the struggles at the Fukushima nuclear station – giving viewers the impression that the dramatic blazes had something to do with nuclear energy.
The reality of the very brief hydrogen explosions was quite different. In those cases, a large, visible volume of smoke erupted and rapidly dissipated. There was no continuing fire, but I am pretty certain you have seen the video clip enough times to have had it impressed into your brain that nuclear plants can explode during an accident. No one has tried to help you put that fact into any context, so it remains unanchored and kind of scary. I can only guess why the only footage I have found of the Chiba refinery fire came during the very first day of the 10 day long blaze.
Have you heard or found any follow-up to the story about the hydroelectric dam that collapsed during the earthquake, destroying 1800 homes? I am just guessing here, but I think that the probability of all of those homes having been empty at the time they were flooded is far lower than the probability of a used pool being emptied. However, no coverage of that accident can be found outside of dusty corners of the internet and no one has even speculated on the death toll from that single renewable energy accident.
Context and comparisons between various sources of energy must play an important role in near term decisions about the use of nuclear energy. We cannot allow people who want us to continue in our present course of consuming fossil fuels as fast as we can extract them to set the agenda for the review. They must explain how slowing nuclear energy helps to improve public safety compared to energy sources like coal, oil, natural gas, hydro, wind, solar, and geothermal. All have some risk, but the measured, numerical risks must be put on the table and rationally evaluated.
One more topic – there is a new Atomic Show Podcast available. On March 20, 2011, I gathered five pro nuclear communicators together for a discussion about our collective and individual efforts to share as much information as we know in response to the earthquake and tsunami disaster that included a nuclear component that turned into the media's focus area.
You can find the podcast at Atomic Show #164 – Fukushima Discussion by Pro Nuclear Communicators. There is an inline player or you can download the file for future consumption. If you like what you hear, please consider subscribing so that you will get the shows whenever they are ready – the production schedule is so fluid as to not actually be a "schedule."
There is going to be a backlash over the kind of coverage this incident got in the media, once the dust settles. The total lack of subtlety that we saw over this period, and the obvious attempt to sensationalize the problems at the reactors while neglecting the wider story of Japan's suffering will not go unpunished. The media are cannibals, and will turn on one another in a flash if they think there is a story, and there is.
PlanetaryGear says
The media has covered several things over the last few years about which I knew a little bit, and I learned that on their best days they only get it mostly right, and on their middling days they get things almost totally wrong. If I didn
The older you get and the more you know, the more likely you'll see a story in the news about a topic you are knowledgeable about. At that point you'll come to the realization that journalists are the most highly educated idiots in society.
John – I agree, except for one point. I don't consider journalists to be all that highly educated.
Now, I have run across some very highly educated idiots in my time (they're not all that uncommon), but they had much more prestigious job descriptions than "journalist."
Think of it this way: for every stupid article that reads "scientists believe" or "science says," there generally has to be a "scientist" somewhere who is actually making the stupid statement referred to in the article.
And dont forget all the articles that begin
judderbar says
I once worked in a very junior capacity in a nuclear testing lab and then got a degree in chemistry and like many people only have a vague idea of what is going on in a disaster like this. I reasoned the Zircalloy could not burn or it would be very difficult to burn but i saw the videos of the plants blowing up more or less in real time. Hydrogen explosions? I am not totally convinced. Criticality could have been achieved in some of these ponds where design restrictions meant there was too much fuel in too small a pond.
Some of the attitude here is that people like me are scaremongers and ignorant and others know better and this kind of attitude will back fire on you. Surely you realise highly toxic fumes are being vented from these plants and this process is not likely to end at best for the next week. It could be months before the thing is contained and fumes are being stored.
Wouldn
Oh, I think that if we had had a criticality incident, we'd know it.
When a reactor starts up it can do so relatively slowly to the critical state and even if goes to super critical the water boils to moderate the reaction and keep it only critical. Where critical is the normal heating of the reactor.
if the rods go critical then water was present at that time. If most of the rods are exposed and hot the zirc cladding can fail and dump the U02 towards the bottom – under the water. A critical event could occur near the bottom of the pool. The water would most likely be immediately dumped out of the pool to stop the fission – just as if the reactor had started but meanwhile the high temperatures have vapourised the zirc and you could get a hydrogen explosion, zirc fire and who knows what – but you would not get an atomic bomb like release of atomic energy.
There was a violent release of energy at one of the reactor buildings.
Not sure why this hasn't gotten any press, but for the last several days Japanese officials have included in their status updates concerns about criticality in the unit #4 spent fuel pond: "renewed nuclear chain reaction feared at spent-fuel storage pool."
EL – It's not news to anyone familiar with situation and the physical phenomena involved.
They (i.e., nuclear professionals) always worry about the possibility of a criticality event. It's almost as if it has been worked into their bones. When are you going to finally realize that the nuclear industry worldwide takes safety very seriously?
Personally, as someone who does not have any responsibility for the safety of the plant and is merely an educated observer, I think that the risks of criticality in the fuel pool are overstated. I won't say impossible, of course, but the possibility is unlikely.
The real news story would have been if the Japanese officials were not considering the possibility of the used fuel in the pool going critical. Then, I would be concerned.
The issue being discussed was not if it will happen but whether it did happen. So far you have confirmed that you believe it would be unlikely but it could happen and you would be concerned if the authorities were not concerned it could happen.
So…….if it did happen the next question is what would be observed at a minimum and what is more likely if it did happen? There would be a range of likely possibilities if the worried about event had happened. According to Wiki, at the TL1 event there was little outside contamination even though there was no containment vessel and the explosion ended as soon as it began to the point people in the room were still alive when firemen entered the room. So in that possibility there would be relatively little to be concerned about outside the immediate area given the wind conditions at the time.
Long story short: things would heat up very quickly; water would convert to steam, thereby removing the moderation; the system would return to subcritical. It is quite possible that this could happen very rapidly and violently, but any damage would be local. Nevertheless, it should be obvious that such an event had occurred.
http://www.youtube.com/watch?v=KZrP3KlmHto
13 neutron beams sampled so far
If it did happen, and all that was observed was what was observed then I guess it was no big deal. If there needs to be discussion on if it happened or not, then it wasn
if criticality only resulted in a steam and hydrogen explosion that only ejected the contents of the MOX fuel rods over the local area where the sea is only about 200m away, while burning some vaporised contents in a brief fire that would fit some of the data so far i think.
The air tight bulldozing tanks were called into removed highly radioactive rubble that was preventing efficient access to the site. Where would such *highly* radioactive rubble have come from?
"Where would such *highly* radioactive rubble have come from?"
They were venting radioactive gasses from the primary containment to the secondary containment, which subsequently experienced a hydrogen explosion. This happened not once, but three times.
@Brian. They were venting radioactive gases from primary containment to outside the reactor building in 1 and 3 (through a hard vent added to the Mark I design at a later point). The leak at the top of the containment structure to the operating floor of the reactor building was a breach of containment (likely through the removable servicing head and flange at the top of the primary containment vessel). This is disputed by GE and NEI (in a briefing note they added responding to accident), but they have described no other pathway for the gas to reach the secondary containment structure in 1 and 3. Reactor 2 had a hydrogen explosion within the primary containment structure involving some components of the torus or piping in the pressure release safety valves (which shunt steam, residual heat, and pressure to the suppression pool).
EL – Oh yeah. The explosion in unit 2 is believed to have occurred near the location of the wet well. It had slipped my mind for a moment.
On the other hand, the "other pathway" is the valve that the operators opened to vent the gases from the primary to the secondary containment, as has been reported for many days by multiple sources.
Hardened vents have been installed on all US Mark I BWR's because the retrofit has been required by the NRC. It is unclear, however, (at least, to me) whether the Fukushima reactors were ever retrofitted.
Your "leak" theory doesn't make sense.
This is going to be an important issue in the subsequent dissection of this accident (venting and hydrogen management). But I'm pretty positive that there isn't a vent that goes into one of the main working areas of the reactor building close to the spent fuel pools and near the servicing hatch for the primary containment vessel. Why on earth would anybody design a venting system for hydrogen into an enclosed area (containing oxygen) and in one of the main working areas of the reactor building? NEI reports the venting of steam from primary containment goes to "outside the reactor building." The best other alternative I have seen, there are tall 100 meter emissions stacks for diffusing vented radioactive gas next to each of the reactor buildings (you've probably seen these in the photos). But these require fans to work properly (and force the gas through filters to remove some of the radioactive particles). Without electrical power to run these fans, there is some thought that gas seeped into adjacent areas along the piping for these vents and into secondary containment. Both theories (and you are right about that) seem to indicate the venting system did not work properly, and may have been a failure of design. E&E publishing (appearing in the Times) is one source looking at these questions.
@PlanetaryGear. I think instrumentation is a big problem overall (PlanetaryGear).
The Japanese Nuclear and Industry Safety Agency (NISA) is publishing daily instrumentation and temperature readings (to the extent this is possible, and the readings are getting more reliable with electrical AC established to control rooms). They are one of the best websites out there providing comprehensive coverage of what is going on at the power plants, worker exposure to radiation, contamination of surrounding areas, etc.
http://www.nisa.meti.go.jp/english/
The challenges are pretty massive
http://www3.nhk.or.jp/daily/english/27_12.html
Tepco report very high concentrations of Iodine 134 with half life of 52.5 minutes probably coming from the core of reactor 2
tom murphy says
"If I could attend the above event, I would ask how anyone who understands radiation, radioactive material, doses, dose rates, and contamination could consider an evacuation order to be a conservative approach focused on protecting the public."
You frame the question to imply that whomever made the evacuation decision must not understand the science. What are the credentials of the Head of the NRC? Does the NRC have a dual mandate, similar to the FAA, to regulate and promote nuclear power generation?
I assume that the NRC understands that any evacuation order must weigh the potential injuries and deaths caused by the evacuation against the potential injuries and deaths that might occur from not giving the evacuation order. I am inclined to give the US NRC the benefit of the doubt especially given TEPCO's history of concealing past events.
I would like to know under what conditions you would have ordered a larger evacuation and how that compares with the NRC guidelines [I assume those guidelines or standards are published].
Thomas Murphy
"What are the credentials of the Head of the NRC?"
Apparently, the only credential necessary is to have a resume composed exclusively of serving as a lackey to two powerful members of congress with strong records of opposing the nuclear industry.
"Does the NRC have a dual mandate, similar to the FAA, to regulate and promote nuclear power generation?"
Heh … That would be a definite no.
YMP Refugeee says
It's hard not to concur with the basic sentiment vis-a-vis Chairman Jaczko, but his credentials do extend slightly beyond what you mention. Even so, it is profoundly odd that our current NRC chairman was an advisor/aide to one of our most anti-nuke politicians (Markey) and to the Senator (Reid) directly responsible for scuttling the Yucca Mountain Project.
The NRC was created (along with DOE) out of the old AEC, which was intentionally split into two agencies because the regulatory wing of the AEC had been accused of being influenced by the "promotional" wing of the agency. Thus, we got NRC, which is supposed to be an independent and impartial regulator of civilian nuclear uses, and DOE, which is supposed to promote, improve, and advance energy technologies (among other things).
Jaczko, sadly, appears to have injected a strong dose of politics into NRC, so it's difficult to refrain from speculating that his very un-NRC-like statement during the Fukushima crisis was politically influenced. His actions with respect to the YMP, if nothing else, have revealed his willingness to brush aside agency traditions and protocols and to justify his actions with mere "legality," which is the hallmark of a politician.
Without going into detail, suffice it to say that time after time the Chairman has made decisions that, while technically permissible, fly in the face of NRC's usually measured and balanced approach. I mean, think about it: NRC commissioners and chairmen are seldom controversial — seldom even known, in fact. And yet here we have a chairman whose name is extremely difficult to pronounce if you've never heard it before ("YATZ-ko"), but every time I've seen him appear in Congress, the politicians pronounce his name as easily as "Abe Lincoln"! Here we have the agency equivalent of a unicorn: A notorious NRC Chairman!
At the same time, I would guess that an unprecedented ex-NRC commissioners and staffers have gone on record disagreeing with things Jaczko has done. Heck, many current NRC staffers have openly disagreed with him, and many others have covertly expressed vehement disapproval of the man.
Most recently, it came to light that a number of high-ranking NRC experts within the division handling the Yucca Mountain license application evaluation have registered open dissent against Jaczko's many unseemly and possibly unethical actions to halt the evaluation and prevent the NRC staff from publishing its analysis (the Safety Evaluation Report). One of these experts, the highly respected Dr. Janet Kotra, really criticizes Jaczko in her dissent, strongly suggesting that his actions have been both unilateral and political. And what is especially striking is that the dissenters took advantage of an option in NRC's process to make their dissents public.
The dissenters clearly wanted to make public their strong disapproval of the Chairman's actions.
YMP Refugeee: "… but his credentials do extend slightly beyond what you mention."
Oh, right. He has a PhD — not in any type of engineering, but in theoretical physics from doing research on baryons and mesons. Note that this is a research degree that he has never actually used, since he went straight from graduate school to Washington DC. The guy has never held a real job in science or engineering.
His credentials extend very slightly indeed.
@tom murphy:
One other thing: I have heard some reports and accusations of TEPCO being less than forthcoming, concealing the severity of past incidents, etc. I don't know if any of that is true, because my information on the subject only comes from media reports.
However, with respect to Chairman Jaczko and what is going on at NRC, I have quite a bit more direct knowledge and "inside information" from people I know in the industry and at the agency. Stuff I hear from the latter doesn't automatically equate with "truth," but it is certainly more detailed and in most cases highly plausible.
I can tell you this about the current Chairman: He has been criticized by the most recent Chairman (Dale Klein) on numerous occasions for impropriety and not respecting NRC traditions and protocols. Usually, Jaczko will not have openly violated any law or regulation in doing so, but he is clearly relying on technicalities and the barely permissible, which is doing great harm (many argue) to the credibility and reputation of the agency.
In other words, though I don't know offhand the NRC guidelines for evacuations, I would suspect that what Jaczko ordered was permissible within the limits of those guidelines, but that most NRC commissioners would have been more prudent and circumspect, in keeping with the agency's almost impersonal image as a neutral regulator. They would not, I suspect, have ordered such an evacuation or openly contradicted another nation's own regulatory agency unless the evidence for doing so was virtually incontrovertible. As events seem to have demonstrated in this case, the evidence was clearly not.
This is just one of many instances, for people who follow the industry, of Jaczko "stepping over the line" in a way we haven't often seen with other NRC commissioners or chairmen. It is part of the reason why many people fear that the agency is becoming not only political, but also the opposite but equally bad thing you yourself mention: except rather than promoting nuclear power generation, Jaczko seems to be demoting or even sabotaging it. His relationship to the industry is starting more strongly to resemble that of Eliot Ness to bootleggers.
Thank you for taking the time to explain this. I looked up his background and was surprised that a science advisor was appointed to that position.
Is the real debate nuclear versus fossil fuels, or is it energy versus no energy? Most anti-nukes think the problem is that we use way too much energy, whatever its origin…
Jerry says
They are anti-energy. Nuclear is a thorn in their side because it provides too much energy too cheap. The Fukushima incident goes to show how abundant nuclear energy is – they have trouble cooling it (heat) and it produces hydrogen (fuel). Oil&gas are expensive and they work to keep them expensive (blocking oil exploration, imposing excessive taxes on it in Europe), so people are forced to use less of them and can't reach higher standards of living (to far above the "natural" way to live). Big Oil likes this and is supporting (funding) it because it restricts the competition – they want to extract and sell the world's oil in slow motion to maximize profits.
Chuck P. says
Once the debate becomes (in the minds of the public), "(mostly) nuclear energy) vs "no energy," it will take about ten minutes for the debate to be won by the nuclear side. Only a few extremists want "no energy." Exposing the true agenda of these extremists will go a long way to aid the accecptance of nuclear energy.
Maybe a new oil (and natural gas) embargo by the Arabs would not be a bad thing.
square1 says
Over the years, I have known, gone to school with, and worked with many people who strongly identify as environmentalists. Some of them were anti-nuclear. I can't think of a single person who could be called "anti-energy." I'm not saying that such people don't exist. Just that those people are so numerically small and politically insignificant that they not worth discussing.
In fact, my off-the-cuff estimate would be, if you can categorize it, that at least 2/3 of the opposition to new nuclear plant construction would be regarding the safety of transporting and permanently storing fuel, rather than safety regarding the operation of the plants themselves (concerns about aging and older-design plants is a different matter).
Jeff Schmidt says
@Rod, "Have you heard or found any follow-up to the story about the hydroelectric dam that collapsed during the earthquake, destroying 1800 homes?"
On aspect, that I think you seem to consistently neglect or just not get, is that one of the biggest reasons people fear nuclear accidents is that if radioisotopes like radioactive Cesium gets out into the environment, it continues to be a problem and put people's health at risk over a somewhat large area, for decades. If a dam busts, it might do a pretty devestating amount of damage in a day, and then it's over. The reservoir is drained, there's no "on-going" harm from the dam stretching decades into the future.
On the other hand, in absolute terms, the dam might kill and injure more people in a day, and destroy homes, businesses, etc, than the radiation would do in all those decades. Personally, if given the choice between dieing today from a flood, gas explosion, oil fire, chemical release, etc, or maybe dieing in a few years from a cancer I wouldn't otherwise have gotten, I'd choose the cancer – I'd get at least that many more years to live before I died. But, I suspect most people probably don't see it the way I do.
I also think that we have the science and technology to secure the radioactive fuel much better than we do dams, gas depots, oil refineries, and coal ash retention ponds. I think we have newer technology than the plants in question in this issue which do an even better job of coping with an extreme disaster such as has occured in Japan, and that even the old tech plants in Fukushima have shown a remarkable resiliency and ability to contain most of the radioactive materials in the face of a series of unfortunate events (including the hydrogen explosions caused by the reactors themselves – they still didn't catastrophically fail despite those explosions).
But, it is important to at least acknowledge the difference between a 'one-time' disaster, and an on-going contamination. With the one-time disaster, you can at least probably rebuild and repopulate the area. If the area gets contaminated, many people will be afraid to live there or do business there, or generally even set foot in the area for any longer than necessary.
50 years ago it was 1 in 12 or so dying of cancer (yet live expectancy was far lower). Now it is 1 in 3, and soon could be 1 in 2. It's easy to invent theories for something causing cancer, since cancer is a puzzle that modern medicine has yet to solve. Then there's the new "health movement" that goes right along with the environmental movement. As long as we consider health more important than any other form of wealth, we will never compete against economic powerhouses such as China.
This appears to be an irrigation dam that broke along the Abukuma River in Fukushima Prefecture on March 12th: "The Sankei Shimbun newspaper reported that the Fujinuma irrigation dam in Sukagawa city, Fukushima, had collapsed, with homes washed away and people missing. The dam was a 57-foot-tall and 436-foot-long embankment-type dam [see photo] located on a tributary of the Abukuma River." Subsequent reports indicate 5 houses were washed away, 4 bodies have been found (and 4 remain missing).
I think the confusion with the numbers comes from this CNN report, which indicates 1,800 houses destroyed in total in Fukushima Prefecture.
That does seems to be the only reported dam collapse EL. There was plenty of confusion in reports early on, which is still echoing around attempts to understand the full picture. Good links.
iorrus mcdonnagh says
Interesting photo of reactor 3. Very difficult to know status of the cooling pond
Bill Hannahan says
Weighing the pros and cons on the evacuation I support it for two reasons.
1… Fear of danger, real or imagined, is damaging to health. The risk and discomfort of an evacuation may be less harmful than being hunkered down in your home in a constant state of fear.
2… A low population dose makes it harder for the UCS to cob up a calculation predicting a large number of latent fatalities.
The most interesting outcome of recent events to me is whether the episode in Japan will change the minds of the somewhat reluctant new supporters of nuclear power, who see it as a tool to combat global warming (or "climate change" or "global climate disruptions" or whatever new marketing term it is using these days).
Of course, I don't expect Barry Brook at Brave New Climate to change his mind. In fact, he has been at the forefront of getting out accurate information on the accident and combating much of the misinformation out there. His efforts should be applauded. I'm referring to the more lukewarm supporters in the climate crowd.
I guess only time will tell, but it is encouraging to see this article from George Monbiot today. I have to say that I wasn't expecting this type of reaction from him, but then again, this is not the first time he has surprised me. I might not agree with Monbiot on certain issues, but to his credit, he is definitely not a knee-jerk automaton, and I respect that.
stephen romer says
Brian thanks for the link it is a great read. This weekend I was at a party talking about this so called nuclear crisis with five of my friends and we came to the same conclusion as George.
Christopher says
Why did the NRC publically release a "Dose Calculation" with no explanation of what the numbers mean, and no context or explanations of the assumptions used to come up with those values? There's probably only a few hundred nuclear professionals that have any idea what those numbers signify, and even they wouldn't know what the source term was that was being assumed in the calc.
http://www.nrc.gov/reading-rm/doc-collections/news/2011/11-050.pdf
rsscmh says
"Dangers of Leaving No Resident Behind" by By Gardiner Harris in the New York Times on March 22, 2011 at page D1 http://www.nytimes.com/2011/03/22/health/22prepare.html
"For Mr. Thornburgh, the lessons of the Three Mile Island accident were to restrain emergency personnel who wanted to act even if such action was not warranted; to resist what he called
I am glad to see you twittered the Monbiot article. He is such a hard core watermelon (green on the outside red on the inside) that some people claim he was the inspiration for the term of internet abuse: "moonbat".
With the NYTimes article I cited below and the Monbiot articles, I think we can claim to be making an impact on the public understanding of the Fukishima incident.
Article about the fossil fuel industry profiting from Japan's tsunami shutdown of nuclear plants: http://rbth.ru/articles/2011/03/22/atomic_growth_12583.html
…The nuclear production capacity Japan lost as a result of the earthquake is equivalent to 13 billion cubic meters of annual gas consumption, or 9 percent of total Gazprom exports…
Robert Steinhaus says
Advocates of fluid fuel reactors can live with a fluid schedule for Atomic Show podcasts.


Sometimes, being considered proficient in a role requires a specified number of credits within a predetermined time frame. In Schoox, you are able to set up types of credits, and then create rules that determine success for those credit types.
Specifically, you can create types of credits, and associate them with a course, or a job, in a way that someone would know that a number of specific course credits should be acquired within a period of time.
For example, "SEO Expert" could be a credit type. You can specify that a Unit manager who wants to be a SEO expert should have ten credits by the end of the year and that he can acquire them by taking courses of a specific category in your academy. To do so, you should associate each course with the relevant amount of credits and types of credits that it should have.
Let's take the procedure step by step.
First, you need to create Credit Types for your academy. To do so, navigate to your Admin tab from the upper navigation menu and select Credits. Under Credits, select Create Types. Give the type a name, and select both the period type and expiration period. Then, click on Add New Type.
Custom time period types start counting six months, or a year, from the day you add the type. Calendar time types count six calendar months or a calendar year. Hire date starts counting from the employees' hire date.
You are able to edit or delete the Type from this panel at any time.
After creating the types, select Create Rules from the same panel. Select the Type, the related job and specify the number of needed credits. You can also select the courses category, which implies that credits will be acquired only from courses that belong in this particular category. Click on Add New Rule to finish.
Please note that you have the option to recalculate the credits for employees that had completed their training prior to the rule set up. Simply click on the button Recalc. However, the credits and completions that will show up in the Credits Dashboard, will be only those that occurred in the defined time frame.
Note: When you select Recalc, no credits will be acquired if there aren't any course completions within the specific time frame you've defined.
You can specify the Types and Number of Credits for each course from the course panel. To do so, navigate to All Courses in the upper navigation bar and select Manage Course under the desired course. In the panel that opens, select Course Info. Scroll down and enter the information. Save before you close.
You can track the number of completions per employee on a separate dashboard. In the admin panel, select Reporting from the left-side menu and Credits Dashboard. Here, you can see the percentage of completions per job. Select the stats icon to filter this information per employee.


text:
Fate/kaleid liner Prisma Illya 2wei Herz! Ad Shows Swimsuit Scene
fhána 's opening song previewed from 3rd magical girl spinoff premiering July 24
Kadokawa began streaming a television commercial for Fate/kaleid liner Prisma Illya 2wei Herz! , the third Fate/kaleid liner Prisma Illya television anime and the sequel to Fate/kaleid liner Prisma Illya 2wei!, on Saturday. The ad features the opening theme song "Wonder Stella" by fhana:
Voice: In this Illya , it's birthday time in swimsuits in the sea!!
Text: Birthdays in swimsuits in the sea!!
Voice & Text: The daily life (!?) of the magical girls takes the stage starting now
Voice & Text: Fate/kaleid liner Prisma Illya 2wei Herz! Dive into summer!
Hiroyama's original Fate/kaleid liner Prisma Illya manga re-imagines the Fate/stay night character Illyasviel von Einzbern in an alternate universe as a magical girl. Fate/kaleid liner Prisma Illya ran in Kadokawa Shoten's Comp Ace from 2007 to 2008. Hiroyama then launched several sequel manga series.
The cast, returning from the Fate/kaled liner Prisma Ilya 2wei show, includes:
Mai Kadowaki as Illyasviel von Einzbern
Kaori Nazuka as Miyu Edelfelt
Chiwa Saito as Chloe Von Einzbern
Shizuka Itou as Luviagelita Edelfelt
Kana Ueda as Rin Tohsaka
Miyu Matsuki as Magical Sapphire
Naoko Takano as Magical Ruby
Sayaka Ohara as Irisviel von Einzbern
Hitomi Nabatame as Bazett Fraga McRemitz
Ami Koshimizu as Caren Hortensia
Noriaki Sugiyama as Shirō Emiya
Haruhi Nanao as Sella
Miho Miyagawa as Leysritt
Rikiya Koyama as Kiritsugu Emiya
Mariya Ise as Nanaki Moriyama
Emiri Katō as Tatsuko Gakumazawa
Kanae Itō as Suzuka Kurihara
Satomi Satou as Mimi Katsura
Miki Itou as Taiga Fujimura
The first television anime premiered in 2013, followed by the second in 2014. Crunchyroll streamed both series as they aired in Japan, and Sentai Filmworks licensed both series for home video release in North America.
The new series will premiere on July 24 on Tokyo MX TV and other channels.
Images © 2015 Hiroshi Hiroyama, Type-Moon / Kadokawa / Prisma Illya 2wei Herz! Production Committee
discuss this in the forum (1 post) |

redpajama_set_name: RedPajamaCommonCrawl


text:
All notable changes to this project will be documented in this file.

The format is mainly based on [Keep a Changelog](http://keepachangelog.com/)
and this project adheres to [Semantic Versioning](http://semver.org/).

## 3.3.0 - 2019-11-05

* Added: The parent folder will be created, if it does not exists

## 3.2.0 - 2019-08-29

* Added: The Path parameter for Start-ScriptLogger can now be an empty string

## 3.1.0 - 2019-02-18

* Added: Optional log rotation (hourly, daily, monthly, yearly)

## 3.0.1 - 2019-02-14

* Changed: Format of the script logger object to show the logger name

## 3.0.0 - 2019-02-14

* Added: Support multiple messages for log functions
* Changed: Support multiple loggers distinguished by a logger name
* Changed: Default log file is now next to the executed script

## 2.0.0 - 2016-12-10

* Changed: Remove positional parameters (BREAKING CHANGE)
* Changed: Convert module to new deployment model
* Changed: Rework code against high quality module guidelines by Microsoft

## 1.2.0 - 2016-03-10

* Added: Encoding option for the log file output
* Added: Error handling for log file and event log output
* Changed: Console output from cmdlets to $Host.UI methods
* Fixed: Error record handling to log correct invocation information

## 1.1.1 - 2016-02-09

* Added: Formats and types resources
* Fixed: Tests for PowerShell 3.0 & 4.0

## 1.1.0 - 2016-02-04

* Added: ErrorRecord parameter to Write-ErrorLog
* Changed: Return logger object inside Start-ScriptLogger

## 1.0.0 - 2016-02-03

* Added: Initial public release

redpajama_set_name: RedPajamaGithub


text:
Posts Tagged 'Inmet'
Copper wars: Lundin deciding on sale
May 13, 2011 businessmining	Comments off
"Lundin Mining Corp. expects to say by the end of May whether it can reach a deal for the sale of the company as a whole or for the sale of individual assets. 'We should be in a position…to give some indication (by the end of this month) in terms…of whether a transaction is likely to arise or not,' Chief Executive Phil Wright said on a conference call Wednesday, following the release late Tuesday of the copper miner's first-quarter results.
Lundin reported higher year-over-year earnings, but they still fell short of expectations as sales suffered from shipping disruptions. Toronto-based Lundin effectively put itself up for sale at the end of March, after a bid by Equinox Minerals Ltd. scotched plans for a merger with Inmet. Barrick Gold Corp. then agreed to buy Equinox, but Lundin executives said at the time they would continue to seek a buyer. Lundin is open to proposals to either sell the company outright or to sell off its assets piecemeal. But a sale or breakup of Lundin is 'not a certainty,' Mr. Wright said Wednesday."
Source: Wall Street Journal, May 11 2011
Lundin management is considering options to sell the company after they did not succeed in merging with Inmet and they decided not to cooperate with a sale to Equinox.
The company's most valuable asset is a 25% stake in the world-class Tenke Fungurume project in Congo. Freeport-McMoran holds the majority stake in this project and has the first right to buy Lundin's stake if Lundin decides to sell.
The difference in taxation of an asset sale compared to a share sale will be an important consideration for Lundin, although the $100mln taxation hit of a total asset sale corresponds to only some 2% of the company value. Most likely it is easier to get a good price for individual assets (especially Tenke Fungurume) and in that way maximize total value for Lundin's shareholders.
The actions by Lundin's management to put the company up for sale seem to indicate mr. Lundin, the founder and chairman of the company, has given up the hope to keep his company independent or to merge it with another small party to create a larger player.
©2011 | Wilfred Visser | thebusinessofmining.com
Categories: Financial reports, Market change Tags: asset sale, business, Congo, copper, DRC, Freeport-McMoran, Inmet, Lundin, mining, mining business, takeover, taxation, Tenke Fugurume
Copper wars: Barrick outbids Minmetals for Equinox
April 26, 2011 businessmining	Comments off
"Barrick Gold Corporation announced today that it has entered into a support agreement with Equinox Minerals Limited for Barrick to acquire, through an all-cash offer, all of the issued and outstanding common shares of Equinox (including the shares represented by Equinox's CHESS Depositary Interests) by way of a friendly take-over offer. The Offer is for C$8.15 per Equinox share in cash, or a total of approximately C$7.3 billion. The Offer represents a 30% premium based on Equinox's closing share price on the Toronto Stock Exchange on February 25, 2011 (the last trading day before Equinox announced its intention to make a take-over bid for the common shares of Lundin Mining Corporation). The Offer also represents a 16% premium over the per share price under the offer for Equinox proposed by Minmetals Resources Ltd. on April 3, 2011 (which offer has not yet commenced)."
Source: Barrick Press Release, April 26 2011
Barrick's appearance as a white knight is a surprising turn in the copper wars, which started in January when Inmet and Lundin announced plans to merge into Symterra
Minmetals dropped its bid for Equinox the day after Barrick's offer, saying that entering into a bidding war would destruct value for its shareholders.
The bid by Barrick has two interesting implications: a continued uncertainty about consolidation in the copper industry; and changing dynamics in the relationship between gold and copper miners.
Consolidation in the copper industry: although Minmetals appears not to enter into a bidding war, other offers for Equinox might follow. The incentive to keep Barrick out of the copper industry might trigger players like Freeport-McMoran and Xstrata/Glencore to make an offer. Furthermore the players that started the copper wars, Inmet and Lundin, are available as takeover or merger targets again.
Copper vs. Gold dynamics: Barrick's entrance into the copper arena is a significant change of strategy for the gold miner. Its Chilean copper operations did not account for more than 10% of revenue until now, but the copper output will be doubled by adding Equinox' capacity. Operational synergies with Equinox' assets in Zambia and Saudi Arabia will not be achieved, thus the acquisition is purely a move for increased diversification. Other gold miners, sitting on piles of cash, might follow Barrick's strategy.
Categories: Mergers & Acquisitions Tags: Barrick, business, consolidation, copper, copper wars, diversification, Equinox, gold, Inmet, Lundin, mining, mining business, Minmetals, Saudi Arabia, takeover, white knight, Zambia
Copper wars: Minmetals in $6.5bn bid for Equinox
April 4, 2011 businessmining	Comments off
"China's Minmetals Resources has launched a C$6.3bn (US$6.5bn) unsolicited bid for Equinox Minerals, the Australian-Canadian copper miner which itself is in the throes of seeking to acquire Vancouver-based Lundin Mining. The bid is the largest-ever unsolicited takeover attempt by a Chinese mining company, at a time when China's miners are increasingly seeking to go abroad.
Minmetals on Sunday night said its all-cash offer of C$7 per share, a 23 per cent premium to Friday's closing price, was a superior alternative for Equinox shareholders to the Lundin acquisition, offering them 'certainty of value and timing in realising their investments'.
The bid is conditional on Equinox dropping its offer for Lundin. Andrew Michelmore, Minmetals' chief executive, said that the Chinese group was only interested in buying Equinox, which he said aligned with Minmetals' strategy for growth and enhanced its global production portfolio."
Source: Financial Times, April 4 2011
Minmetals is the third stage in the developing copper wars for consolidation in the industry. In the first stage Lundin and Inmet proposed a merger of equals named Symterra. In the second stage this merger was derailed by a takeover attempt of Lundin by Equinox.
Minmetals is one of the most active Chinese companies in foreign investment, buying most of the assets of Australian OZ Minerals to form Minerals and Metals Group (MMG) in 2009 for $1.4bln. It appears Minerals and Metals Group and Equinox will be combined. MMG is mainly run by western managers.
For most shareholders the all-cash offer of Minmetals will be preferable to the takeover of Lundin, which would increase the gearing of the company to dangerous levels. Equinox' management might be able to get a slightly better price from Minmetals, but it is unlikely that the company will stay independent.
The announcement of Minmetals comes on the same day the World Copper Conference kicks off in Santiago. Many of the industry's CEOs are gathered for this event. Also today, Chinalco announced its intention to expand the scope of activities from aluminium to other commodities, including copper. It is unlikely that other state-controlled Chinese companies will come with a competing offer for Equinox, but the meetings around the Copper Conference might trigger other M&A developments in the industry.
Categories: Mergers & Acquisitions Tags: acquisition, business, Canada, China, Chinalco, copper, Equinox, Inmet, Lundin, merger, Minerals and Metals Group, mining, mining business, Minmetals, OZ Minerals, Symterra, takeover, World Copper Conference
Lundin and Inmet abandon proposed merger
March 30, 2011 businessmining	Comments off
"Lundin Mining Corporation and Inmet Mining Corporation jointly announced today that they have terminated the arrangement agreement dated January 12, 2011 between them in accordance with its terms.
As a result, the formerly announced Special Meetings of Shareholders of both Inmet and Lundin Mining, scheduled for April 4, 2011, are cancelled. The parties have agreed that Inmet's right to a break fee of $120 million, in accordance with the arrangement agreement, will be preserved in connection with the unsolicited offer of Equinox Minerals Limited to acquire Lundin Mining."
Source: Inmet Press Release, March 30 2011
Continuation of the merger became highly unlikely after the government of Panama did not give permission to coal-fire the power plant for Inmet's flagship Cobre Panama project. Any alternative source of power will reduce project value by over 10%, causing a material change to the proposed merger agreement. Still Inmet will receive $120mln because the breakup is attributed to the Equinox offer.
Lundin advised its shareholders to reject the competing offer by Equinox last week. Key arguments mentioned in the explaining circular are: inadequate pricing; high leverage of resulting company; potential shortage of cash for investments; and increased geo-political risk. However, mr. Lundin commented that he would be willing to sell a an adequate price.
Equinox refers in its circular to a 64% premium paid since 2004 in large mining takeovers. This reference could be seen as a counterbid to the 26% pre-announcement premium of Equinox' offer. Increasing the premium to approx. 40% (to $9.00/share) will convince most shareholders to tender their shares if the financial risk can be sufficiently covered.
No competing bidders for Lundin have emerged and Lundin does not report looking for alternatives at this moment. As Equinox is stretching its financial capacity with this deal, a competing bidder might be able to take over Lundin by offering only slightly more than a potential sweetened Equinox bid.
Categories: Mergers & Acquisitions Tags: acquisition, business, Cobre Panama, copper, Equinox, Inmet, Lundin, merger, mining, mining business, Panama, takeover
Copper wars: Equinox, Lundin & Inmet
March 1, 2011 businessmining	Comments off
"African-focused copper miner Equinox Minerals (EQN.TO) offered C$4.8 billion ($4.9 billion) to buy Canada's Lundin Mining (LUN.TO) in an unsolicited bid that threatens to scuttle Lundin's rival C$9 billion tie-up with Inmet Mining. The cash and shares bid could kick off a bidding war for the base metal miner as near record copper prices and expected supply shortages spurs another round of consolidation in the global resources sector, analysts said.
The proposed bid comes just over a month after Lundin and Inmet Mining Corp (IMN.TO), a copper miner with operations in Spain, Turkey and Finland, agreed to combine and create a new Canadian copper mining major called Symterra, worth about C$9 billion ($9.2 billion)."
Source: Reuters, February 28 2011
Equinox offers a combination of cash and shares, worth C$8.10 per share of Lundin; a 26% premium over current share price. This is more or less the price to which Lundin's shares increased after the January 12 announcement of the merger with Inmet, but Lundin's share price has dropped over 20% in the past 5 weeks.
The proposed deal between Lundin and Inmet to form Symterra is a 'friendly' merger, in which the boards advise the shareholders to vote for the exchange of shares in a shareholder meeting (planned for March 14th). Equinox' offer is a 'hostile' takeover: an official procedure in which an offer is made for all outstanding shares, for which no board approval or shareholder approval from the target is required.
Equinox' board presents the deal as clearly superior to the Symterra merger plan, using the short term growth perspective as key argument. The value driver for the Symterra deal would be the development of Inmet's Cobre Panama project, for which it required the spending power of Lundin. The recommendation of Lundin's board to the shareholders will be crucial for the outcome of the battle.
A combination of forces of the 3 companies should not be ruled out, as it would maximize the synergies between the firms. This would create a player with copper output similar to Rio Tinto's copper production. Clearly combining 3 companies would not only face integration obstacles, but would also depend heavily on the ability of the management teams to cooperate.
Potential rival bidders for Lundin (and/or Equinox and Inmet) include BHP Billiton, Rio Tinto, Freeport-McMoran, Teck, First Quantum, and Chinese players. Vale communicated that acquisitions of this size would not be likely, though it would help the company to diversify. With the battle for ownership opened it would be surprising if more than one company out of the group of Lundin, Equinox and Inmet survives this year stand-alone.
Categories: Market change, Mergers & Acquisitions Tags: acquisition, business, copper, Equinox, Inmet, Inmet Mining, lead, Lundin, merger, mining, mining business, shares, Symterra, takeover, zinc
Symterra: Inmet, Lundin Merger to Forge Copper Mining Giant
"Inmet Mining Corp.'s planned merger with Lundin Mining Corp. will catapult the combined 9 billion Canadian dollars (US $9.1 billion) miner among the world's biggest copper producers as demand for the widely used industrial metal shows no signs of easing.
The combined company, to be known as Symterra Corp., will generate annual production of around 500,000 metric tons of copper starting in 2017, up from around an estimated 205,000 metric tons this year, ranking it among world's top five senior copper producers. Chile's Antofagasta PLC is the biggest copper producer, with output of more than 600,000 metric tons estimated for this year.
Inmet and Lundin, both based in Toronto, will combine five copper mines in Portugal, Spain, Turkey, Sweden and Finland with two huge copper projects—Inmet's 80%-owned Cobre Panama operation, one of the world's largest undeveloped copper projects with a mine life exceeding 30 years, and Lundin's 24.8% stake in the Tenke Fungurume mine in the Democratic Republic of Congo. The initial phase of that project calls for a 40-year mine."
Source: Wall Street Journal, January 13 2011
Although both headquartered in Toronto, Lundin and Inmet don't have operations in North America. Most of the current production takes place in Europe, with focus of production in the future shifting to Asia, Africa and potentially Latin America.
The market capitalization of both firms is roughly equal at $4.4bln. Inmet has demonstrated a stable performance over the past years with profit margin in the range of 25-50%. Lundin has not been as profitable yet, but has access to the promising Tenke Fungurume project.
The main driver for the merger is combined spending power for the development of Cobre Panama and Fungurume and the dilution of political risk associated with operation in Papua New Guinea and Congo.
Analysts point to the difference in corporate cultures of the two companies as a potential obstacle for smooth integration. The composition of the new board, with Inmet's Jochen Tilk as president & CEO, indicates that Inmet's 'corporate citizenship' culture might become dominant.
Categories: Mergers & Acquisitions Tags: business, Canada, copper, culture, gold, Inmet, lead, Lundin, merger, mining, mining business, nickel, Symterra, zinc


Unable to obtain a ticket using API for OAM-integrated Sites instance.
- e.g. using com.fatwire.wem.sso.SSOSession.getMultiTicket() to get a multiticket from an OAM-integrated Sites instance.
1) Unable to install Community Gadgets with OAM-integrated Sites instance.
- The above exception is seen in the CG logs when deploying the Production application.
2) Unable to use CSDT with OAM-integrated Sites instance.
- The above exception is seen in Eclipse error console after connecting to the Sites instance.


text:
Monday, October 1st, 2018
September 30, 2018 Reception	Leave a comment
7:45 – 8:30 a.m. Wake up and Warm Up Emily C.
8:45 -10:00 a.m. Slow Flow Emily C.
12:30 -1:15 p.m. Beginning Roxanne G.
5:45 – 7:00 p.m. Beginning Kat B.
7:30 – 8:45 p.m. Balanced Stretch, Flow & Inversion Victor D.
Noon-1:15pm: Gentle Beginning with Kat B.
1:45-3:00pm: Slow Flow with Mel
Noon-4pm: Tomek
Saturday September 29th 2018
10:00-11:30 a.m. Intermediate Victor D.
12:00- 1:15 p.m. Beginning Victor D.
7:45-8:30 a.m. Wake Up and Warm Up with Emily C.
8:45-10:00 a.m. Slow Flow with Ashley R.
12:30-1:15 p.m. Gentle Beginning with Ashley R.
10:00 a.m. – 2:00 p.m. with Cecily
2:30 p.m. – 6:30 p.m. with Rose
9:00 a.m. – 6:00 p.m. with Jocelyn
7:45-8:30 Gentle Wake Up with Emily C.
8:45-10:00 Stretch out and Chill Out with Roxanne G.
12:30-1:15 Balanced Stretch and Flow with Victor D.
5:30-7:15 Challenging Stretch, Flow and Inversion with Victor D.
Rose from 12:30-4:30 p.m.
Jocelyn from 2:00-5:30 p.m.
7:45 – 8:30 a.m. Wake Up and Warm Up with Emily C.
8:45 – 10:00 a.m. Slow Flow with Emily C.
12:30 – 1:15 p.m. Gentle Beginning with Victor D.
5:45 – 7:00 p.m. Gentle Beginning with Victor D.
9:00 a.m. – 12:00 p.m. with Jocelyn
4:30 – 8:30 p.m. with Tomek
7:45-8:30 a.m. Gentle Wake Up with Emily C.
8:45-10:00 a.m. Stretch Out and Chill Out with Victor.
12:30-1:15 p.m. Balanced Stretch & Flow with Victor D.
5:30-7:15 p.m. Challenging Stretch, Flow & Inversion with Victor D.
7:30 a.m.-12:15 p.m. and 2:00-5:00 p.m. with Jocelyn D.
4:30-8:30 p.m. with Cecily H.
8:45 –10:00 a.m. Slow Flow Emily C.
12:30 -1:15 p.m. Beginning Ashley R.
Sunday, September 23rd, 2018
1:45-3:00pm: Slow Flow with Ashley R.
Saturday, September 22nd 2018


text:
Alexion Pharmaceuticals, Inc. (ALXN) SEC Filing 8-K Material Event for the period ending Thursday, February 4, 2021
Alexion Pharmaceuticals, Inc. (ALXN)
8-K Material Event Thu Feb 04 2021
ALXN Valuations
ALXN Annual Reports
ALXN Quarterly Reports
ALXN Corporate News
Change in Control
Ending Agreement
Security Holders Change
ALXN Merger Prospectus
425 Merger Prospectus July 2021
425 Merger Prospectus June 2021
425 Merger Prospectus May 2021
Last10K.com | 8-K Material Event Thu Feb 04 2021
Alexion Pharmaceuticals, Inc.
CIK: 899866 Ticker: ALXN
Earnings Press Release 8-K Corporate News
Alexion Reports Fourth Quarter and Full Year 2020 Results
•4Q20 total revenues of $1,591.8 million, a 15% increase over 4Q19
•4Q20 GAAP diluted EPS of $2.42; non-GAAP diluted EPS of $2.96
•Announced agreement to be acquired by AstraZeneca; transaction expected to close in Q3 2021
•Received EU approval for ULTOMIRIS® (ravulizumab) 100 mg/mL higher concentration formulation in paroxysmal nocturnal hemoglobinuria (PNH) & atypical hemolytic uremic syndrome (aHUS)
•Continued advancement of pipeline, including initiation of three Phase 3 development programs and two novel IND filings in Q4 2020
BOSTON, February 4, 2021 - Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced financial results for the fourth quarter and full year of 2020. Total revenues for the full year of 2020 were $6,069.9 million, a 22 percent increase compared to the same period in 2019. The negative impact of foreign currency on total revenues year-over-year was 1 percent, or $52.0 million, inclusive of hedging activities. On a GAAP basis, diluted EPS for the full year of 2020 was $2.72, compared to $10.70 in the prior year. Full year 2020 includes impairment charges of $2,053.3 million primarily relating to the KANUMA intangible asset and a related deferred tax benefit of $377.3 million. Full year 2019 includes one-time tax benefits of $382.2 million related to intra-entity asset transfers of intellectual property. Non-GAAP diluted EPS for the full year of 2020 was $12.51, a 19 percent increase versus the prior year.
Total revenues in the fourth quarter were $1,591.8 million, a 15 percent increase compared to the same period in 2019. The positive impact of foreign currency on total revenues year-over-year was less than 1 percent, or $0.1 million, inclusive of hedging activities. On a GAAP basis, diluted EPS in the quarter was $2.42, compared to $4.00 in the prior year, inclusive of one-time tax benefits of $382.2 million related to intra-entity asset transfers of intellectual property in the fourth quarter of 2019. Non-GAAP diluted EPS for the fourth quarter of 2020 was $2.96, a 9 percent increase versus the fourth quarter of 2019.
"In 2020, we delivered on our LEAD-EXPAND-DIVERSIFY strategy - progressing our commercial portfolio with multiple global regulatory approvals, and further building our pipeline, which now spans more than 20 development programs. I am so proud of our team's remarkable execution and perseverance amidst the uncertainties of COVID-19," said Ludwig Hantson, Ph.D., Chief Executive Officer of Alexion. "We enter 2021 with significant momentum, a strong foundation and a promising future. I am confident we are well positioned to build on our success and further advance our mission of delivering life-changing medicines to people with rare diseases and devastating conditions in the coming months and once we become part of AstraZeneca."
Full Year 2020 Financial Highlights
•Net product sales were $6,069.1 million, compared to $4,990.0 million in 2019.
•SOLIRIS net product sales were $4,064.2 million, compared to $3,946.4 million in 2019, representing a 3 percent increase.
•ULTOMIRIS net product sales were $1,076.7 million, compared to $338.9 million in 2019, representing a 218 percent increase.
•STRENSIQ net product sales were $731.8 million, compared to $592.5 million in 2019, representing a 24 percent increase.
•KANUMA net product sales were $117.9 million, compared to $112.2 million in 2019, representing a 5 percent increase.
•ANDEXXA/ONDEXXYA net product sales were $78.5 million.
•GAAP cost of sales was $553.5 million, compared to $394.5 million in 2019. Non-GAAP cost of sales was $518.2 million, compared to $380.3 million in 2019.
•GAAP R&D expense was $1,002.9 million, compared to $886.0 million in 2019. Non-GAAP R&D expense was $929.4 million, compared to $720.9 million in 2019.
•GAAP SG&A expense was $1,399.9 million, compared to $1,261.1 million in 2019. Non-GAAP SG&A expense was $1,198.6 million, compared to $1,099.9 million in 2019.
•GAAP impairment of intangible assets was $2,053.3 million primarily related to an impairment charge recorded during the second quarter 2020 related to the KANUMA intangible asset.
•GAAP income tax benefit was $34.4 million, compared to $225.5 million in 2019. GAAP income tax benefit for 2020 includes a deferred tax benefit of $377.3 million associated with the impairment charge related to the KANUMA intangible asset. GAAP income tax benefit for 2019 includes one-time tax benefits of $382.2 million related to intra-entity asset transfers of intellectual property in 2019. Non-GAAP income tax expense was $512.8 million, compared to $359.4 million in 2019.
•GAAP diluted EPS was $2.72, compared to $10.70 in 2019. GAAP diluted EPS for 2020 includes impairment charges of $2,053.3 million primarily relating to the KANUMA intangible asset, offset by a deferred tax benefit of $377.3 million associated with the KANUMA impairment charge. GAAP diluted EPS for 2019 includes one-time tax benefits of $382.2 million related to intra-entity asset transfers of intellectual property in 2019. Non-GAAP diluted EPS was $12.51, compared to $10.53 in 2019.
Fourth Quarter 2020 Financial Highlights
•Net product sales were $1,591.7 million in the fourth quarter of 2020, compared to $1,384.2 million in the fourth quarter of 2019.
•SOLIRIS net product sales were $1,023.5 million, compared to $1,013.1 million in the fourth quarter of 2019, representing a 1 percent increase.
•ULTOMIRIS net product sales were $313.5 million, compared to $170.2 million in the fourth quarter of 2019, representing an 84 percent increase.
•STRENSIQ net product sales were $185.9 million, compared to $166.8 million in the fourth quarter of 2019, representing an 11 percent increase.
•KANUMA net product sales were $29.2 million, compared to $34.1 million in the fourth quarter of 2019, representing a 14 percent decrease.
•ANDEXXA/ONDEXXYA net product sales were $39.6 million in the fourth quarter of 2020.
•GAAP cost of sales was $152.2 million, compared to $114.3 million in the fourth quarter of 2019. Non-GAAP cost of sales was $138.0 million, compared to $110.8 million in the fourth quarter of 2019.
•GAAP R&D expense was $295.0 million, compared to $269.6 million in the fourth quarter of 2019. Non-GAAP R&D expense was $269.8 million, compared to $226.7 million in the fourth quarter of 2019.
•GAAP SG&A expense was $444.4 million, compared to $381.0 million in the fourth quarter of 2019. Non-GAAP SG&A expense was $384.6 million, compared to $340.0 million in the fourth quarter of 2019.
•GAAP income tax expense was $54.8 million, compared to income tax benefit of $287.0 million in the fourth quarter of 2019, inclusive of one-time tax benefits related to intra-entity asset transfers of intellectual property in the fourth quarter of 2019. Non-GAAP income tax expense was $111.0 million, compared to $85.8 million in the fourth quarter of 2019.
•GAAP diluted EPS was $2.42, compared to $4.00 in the fourth quarter of 2019, inclusive of one-time tax benefits related to intra-entity asset transfers of intellectual property in the fourth quarter of 2019. Non-GAAP diluted EPS was $2.96, compared to $2.71 in the fourth quarter of 2019.
We continue to take steps to proactively respond to the evolving COVID-19 pandemic and to plan for related uncertainties. We remain focused on continuing to serve patients, protecting the health and safety of our employees and the communities in which we live and work, and supporting patients in clinical trials. We are also focused on minimizing potential interactions that could contribute to the spread of the virus and put additional strain on healthcare systems through the use of innovative virtual means where possible.
•Clinical Trials: We have implemented a pandemic response business continuity plan designed to protect patients and site staff safety while continuing our clinical trials with limited interruption to the extent we are able. The COVID-19 impact has varied by study and program, but there has been little timing impact on fully-enrolled trials. By the third quarter of 2020, we had successfully re-initiated the majority of studies that had been temporarily paused earlier in the year. However, increasing COVID-19 cases have had further effects on the timing of healthy volunteer studies in particular. In addition, there has been, and may continue to be, an impact to the timing of trials that are enrolling patients and activating sites, or have not yet started to do so, based on local dynamics where these studies are being conducted.
•Business Impact: We continue to take proactive measures designed to mitigate the risk of potential interruptions in supply and/or access to patients' customary site-of-care locations. Treatment compliance rates across all our medicines have remained strong. We have also seen the predicted slowing of new patient initiations and delays in treatment starts, and we are continuing to closely monitor this environment as the pandemic continues.
•SOLIRIS - Guillain-Barre Syndrome (GBS): SOLIRIS in GBS has been granted SAKIGAKE designation by Japan's Ministry of Health, Labour and Welfare (MHLW). Alexion plans to initiate a Phase 3 study of SOLIRIS in GBS in Japan in the first half of 2021.
•ULTOMIRIS - 100 mg/mL: In November 2020, the ULTOMIRIS 100 mg/mL formulation for PNH and aHUS was approved in the EU. An application for approval is under review in Japan. This higher concentration formulation is designed to reduce infusion time by more than 60 percent to approximately 45 minutes.
•ULTOMIRIS - Subcutaneous: The Phase 3 study of weekly subcutaneous (SC) ULTOMIRIS demonstrated PK-based non-inferiority versus intravenous ULTOMIRIS. Pending collection of 12-month safety and drug-device combination data, Alexion plans to file for approval in the U.S. and EU for the ULTOMIRIS SC formulation and device combination in PNH and aHUS in the third quarter of 2021.
•ULTOMIRIS - gMG: In November 2020, Alexion completed enrollment in the Phase 3 study of ULTOMIRIS in adults with gMG. Study results are expected in the second half of 2021.
•ULTOMIRIS - NMOSD: A Phase 3 study of ULTOMIRIS in NMOSD is underway.
•ULTOMIRIS - Amyotrophic Lateral Sclerosis (ALS): As completion of full enrollment nears, screening of new patients has closed for the Phase 3 study of ULTOMIRIS in ALS.
•ULTOMIRIS - Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy (HSCT-TMA): Dosing is underway in Phase 3 studies of ULTOMIRIS in adults and children with HSCT-TMA.
•ULTOMIRIS - Complement Mediated Thrombotic Microangiopathy (CM-TMA): In January 2021, Alexion submitted an Investigational New Drug (IND) application for ULTOMIRIS in CM-TMA and plans to initiate a Phase 3 study in the first half of 2021.
•ULTOMIRIS - Severe COVID-19: In January 2021, Alexion paused further enrollment in a Phase 3 trial of ULTOMIRIS in adults hospitalized with severe COVID-19 requiring mechanical ventilation, due to lack of efficacy, pending further analysis of the data. This decision was made based on the recommendation of an independent data monitoring committee, following their review of data from a pre-specified interim analysis. Alexion continues to provide ULTOMIRIS for the ongoing TACTIC-R platform study led by Cambridge University Hospitals NHS Foundation Trust, which is evaluating the potential of earlier immune modulatory treatment (hospitalized patients not requiring mechanical ventilation) in preventing progression of the virus.
•ULTOMIRIS - Dermatomyositis (DM): Alexion plans to initiate a Phase 2/3 study of ULTOMIRIS in DM in the second half of 2021, pending regulatory feedback.
•ALXN1840 - Wilson Disease: Enrollment is complete in a Phase 3 study of ALXN1840 in Wilson disease. Study results are expected in the first half of 2021.
•CAEL-101 - Caelum Biosciences: Alexion and Caelum Biosciences are conducting the Cardiac Amyloid Reaching for Extended Survival (CARES) Phase 3 clinical program to evaluate CAEL-101, a first-in-class amyloid fibril targeted therapy, in combination with standard-of-care therapy in AL amyloidosis. Dosing is underway in two parallel Phase 3 studies – one in patients with Mayo stage IIIa disease and one in patients with Mayo stage IIIb disease.
•ALXN2060 (AG10): Alexion holds an exclusive license to develop and commercialize ALXN2060 (AG10) in Japan. Eidos is currently evaluating AG10 in two Phase 3 studies in the U.S. and Europe – one for ATTR cardiomyopathy (ATTR-CM) and one for ATTR polyneuropathy (ATTR-PN). In October 2020, Alexion initiated a Phase 3 bridging study of ALXN2060 for patients with ATTR-CM in Japan and dosing is underway.
•ALXN2040 (Danicopan) - PNH with Extravascular Hemolysis (EVH): In December 2020, Alexion initiated a Phase 3 study of ALXN2040 as an add-on therapy for PNH patients with EVH and dosing is underway.
•ANDEXXA - Acute Intracranial Hemorrhage (ICH): The Phase 4 ANNEXA-I study - designed to provide clinical data supporting full approval - is underway to assess ANDEXXA compared to usual standard of care in patients presenting with acute intracranial hemorrhage while taking an oral Factor Xa inhibitor. In December 2020, Alexion submitted a supplemental Biologics License Application (sBLA) to the U.S. FDA to enable the addition of edoxaban and enoxaparin to the U.S. label. Alexion plans to file for regulatory approval of ANDEXXA in Japan in the first quarter of 2021.
•ULTOMIRIS - Renal Diseases: In November 2020, Alexion initiated a proof-of-concept study of ULTOMIRIS in patients with IgA nephropathy and lupus nephritis.
•ALXN1830: Due to COVID-19, Alexion discontinued the Phase 2 study of ALXN1830, administered intravenously, in warm autoimmune hemolytic anemia (WAIHA) and the Phase 1 study of a subcutaneous formulation of ALXN1830 in healthy volunteers. In January 2021, a Clinical Trial Application (CTA) for a new Phase 1 study of subcutaneous ALXN1830 was approved in New Zealand; study initiation is planned for the first quarter of 2021. Following successful completion of the Phase 1 study, Alexion plans to initiate Phase 2 studies of subcutaneous ALXN1830 in gMG and WAIHA in 2021, pending regulatory feedback.
•ALXN2040 - Geographic Atrophy (GA): Alexion plans to initiate a Phase 2 study of ALXN2040 in GA in the second half of 2021.
•ALXN2040 - COVID-19: Alexion has agreed to provide ALXN2040 to the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, for the ACTIV-5 Big Effect Trial in adults hospitalized with COVID-19. This Phase 2 platform trial is comparing different investigational therapies to a common control arm with the intent of identifying promising treatments to enter a more definitive study.
•ALXN2050 - PNH: Alexion has paused additional enrollment in the Phase 2 study of ALXN2050 monotherapy in PNH patients, pending the receipt of further Phase 1 data (expected in the second quarter of 2021) that will allow for dose escalation in the Phase 2 study.
•ALXN2050 - Renal Diseases: Alexion plans to initiate a proof-of-concept study of ALXN2050 in patients with various renal diseases in 2021, pending regulatory feedback.
•ALXN1720: The Phase 1 healthy volunteer study of ALXN1720, a novel anti-C5 albumin-binding bi-specific mini-body that is designed to bind and prevent activation of human C5, has been paused for a second time due to COVID-19. Additional cohorts have been added to the study to explore higher doses and enable the initiation of a Phase 3 study in gMG, pending successful completion of the Phase 1 study as has been agreed with the FDA. Data from the Phase 1 study are expected in the second half of 2021. Alexion also plans to initiate a study of ALXN1720 in DM.
•ANDEXXA - Urgent Surgery: ANDEXXA is currently being evaluated in a single-arm, open-label Phase 2 study in patients taking apixaban, rivaroxaban, edoxaban, or enoxaparin who require urgent surgery. The results of this study will inform the design of a randomized controlled Phase 3 clinical trial to expand the label in this population.
•ALXN2075 (cerdulatinib): Acquired as part of the Portola acquisition, ALXN2075 is a dual spleen tyrosine kinase and janus kinase (SYK/JAK) inhibitor being evaluated in a Phase 1/2a study in patients with relapsed/refractory chronic lymphocytic leukemia or B-cell or T-cell non-Hodgkin lymphoma. Data are expected in the first half of 2021.
•ALXN1820: In January 2021, Alexion initiated a Phase 1 study of ALXN1820, its bi-specific anti-properdin mini-body, in healthy volunteers.
•ALXN1850 - Hypophosphatasia (HPP): In November 2020, Alexion submitted an IND application to the FDA for ALXN1850, its next generation asfotase alfa asset. Initiation of a Phase 1 study in adults with HPP is planned for the second quarter of 2021.
Conference Call/Earnings Materials:
Given the recently announced agreement for Alexion to be acquired by AstraZeneca, Alexion will not be hosting a conference call. Earnings materials are available publicly on the Investor Relations page of our website at http://ir.alexion.com. Questions may be directed to the Investor Relations team via e-mail at InvestorRelations@Alexion.com or the contact information below.
About Alexion
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. As a leader in rare diseases for more than 25 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D) as well as the first and only approved Factor Xa inhibitor reversal agent. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on hematology, nephrology, neurology, metabolic disorders, cardiology, ophthalmology and acute care. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. This press release and further information about Alexion can be found at: www.alexion.com.
[ALXN-E]
In connection with the proposed transaction, AstraZeneca PLC ("AstraZeneca") intends to file with the SEC a registration statement on Form F-4 that will include a proxy statement of Alexion and that also constitutes a prospectus of AstraZeneca. Each of Alexion and AstraZeneca may also file other relevant documents with the U.S. Securities and Exchange Commission ("SEC") regarding the proposed transaction. This document is not a substitute for the proxy statement/prospectus or registration statement or any other document that Alexion or AstraZeneca may file with the SEC. The definitive proxy statement/prospectus (if and when available) will be mailed to stockholders of Alexion. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE REGISTRATION STATEMENT, PROXY STATEMENT/PROSPECTUS AND ANY OTHER RELEVANT DOCUMENTS THAT MAY BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and security holders will be able to obtain free copies of the registration statement and proxy statement/prospectus (if and when available) and other documents containing important information about Alexion, AstraZeneca and the proposed transaction, once such documents are filed with the SEC through the website maintained by the SEC at http://www.sec.gov. Copies of the documents filed with the SEC by Alexion will be available free of charge on Alexion's website at http://www.alexion.com or by contacting Alexion's Investor Relations Department by email at InvestorRelations@alexion.com. Copies of the documents filed with the SEC by AstraZeneca will be available free of charge on AstraZeneca's website at https://www.astrazeneca.com/investor-relations.html or by contacting AstraZeneca's Investor Relations department by email at global-mediateam@astrazeneca.com.
Participants in the Solicitation
Alexion, AstraZeneca, their respective directors and certain of their executive officers and other employees may be deemed to be participants in the solicitation of proxies from Alexion's stockholders in connection with the proposed transaction. Information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of Alexion stockholders in connection with the proposed mergers, including a description of their direct or indirect interests, by security holdings or otherwise, will be set forth in the proxy statement/prospectus when it is filed with the SEC. Information about Alexion's directors and executive officers is available in Alexion's proxy statement for its 2020 annual meeting of stockholders, which was filed with the SEC on March 26, 2020, Alexion's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, which was filed with the SEC on February 4, 2020, and other documents subsequently filed by Alexion with the SEC. Information about AstraZeneca's directors and executive officers is available in AstraZeneca's Form 20-F filed with the SEC on March 3, 2020, and other documents subsequently filed by AstraZeneca with the SEC.
This communication is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended.
This communication contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. You can generally identify forward-looking statements by the use of forward-looking terminology such as "anticipate," "believe," "continue," "could," "estimate," "expect," "explore," "evaluate," "intend," "may," "might," "plan," "potential," "predict," "project," "seek," "should," or "will," or the negative thereof or other variations thereon or comparable terminology. These forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond Alexion's control. Statements in this communication regarding Alexion, AstraZeneca and the combined company that are forward-looking, including anticipated benefits of the proposed transaction, the impact of the proposed transaction on Alexion's and AstraZeneca's businesses, that Alexion is well positioned to build on its success, the anticipated timing of initiation, enrollment, reporting results of clinical trials, the timing of filing for regulatory approvals and receipt of approvals are based on management's estimates, assumptions and projections, and are subject to significant uncertainties and other factors, many of which are beyond Alexion's and AstraZeneca's control. These factors include, among other things, market factors, completion of the audit of Alexion's fiscal year 2020 financial results, competitive product development and approvals, pricing controls and pressures (including changes in rules and practices of managed care groups and institutional and governmental purchasers), economic conditions such as interest rate and currency exchange rate fluctuations, judicial decisions, claims and concerns that may arise regarding the safety and efficacy of in-line products and product candidates, changes to wholesaler inventory levels, variability in data provided by third parties, changes in, and interpretation of, governmental regulations and legislation affecting domestic or foreign operations, including tax obligations, changes to business or tax planning strategies, difficulties and delays in product development, manufacturing or sales including any potential future recalls, patent positions and the ultimate outcome of any litigation matter. Additional information concerning these risks, uncertainties and assumptions can be found in Alexion's filings with the SEC, including the risk factors discussed in Alexion's most recent Annual Report on Form 10-K, as updated by its Quarterly Reports on Form 10-Q, and in Alexion's future filings with the SEC. Important risk factors could cause actual future results and other future events to differ materially from those currently estimated by management, including, but not limited to, the risks that: a condition to the closing the proposed acquisition may not be satisfied; a regulatory approval that may be required for the proposed acquisition is delayed, is
not obtained or is obtained subject to conditions that are not anticipated; management's time and attention is diverted on transaction related issues; disruption from the transaction makes it more difficult to maintain business, contractual and operational relationships; the credit ratings of the combined company declines following the proposed acquisition; legal proceedings are instituted against Alexion, AstraZeneca or the combined company; Alexion is unable to retain key personnel; and the announcement or the consummation of the proposed acquisition has a negative effect on the market price of the capital stock of Alexion or on Alexion's operating results. No assurances can be given that any of the events anticipated by the forward-looking statements will transpire or occur, or if any of them do occur, what impact they will have on the results of operations, financial condition or cash flows of Alexion. Should any risks and uncertainties develop into actual events, these developments could have a material adverse effect on the proposed transaction and/or Alexion. You are cautioned not to rely on Alexion's forward-looking statements. These forward-looking statements are and will be based upon management's then-current views and assumptions regarding future events and operating performance, and are applicable only as of the dates of such statements. Alexion assumes no duty to update or revise forward-looking statements, whether as a result of new information, future events or otherwise, as of any future date.
In addition to financial information prepared in accordance with GAAP, this press release also contains non-GAAP financial measures that Alexion believes, when considered together with the GAAP information, provide investors and management with supplemental information relating to performance, trends and prospects that promote a more complete understanding of our operating results and financial position during different periods. Alexion also uses these non-GAAP financial measures to establish budgets, set operational goals and to evaluate the performance of the business. The non-GAAP results, determined in accordance with our internal policies, exclude the impact of the following GAAP items (see reconciliation tables below for additional information): share-based compensation expense, fair value adjustment of inventory acquired, amortization of purchased intangible assets, changes in fair value of contingent consideration, restructuring and related expenses, upfront payments related to licenses and other strategic agreements, acquired in-process research and development, impairment of purchased intangible assets, gains and losses related to strategic equity investments, litigation charges, gain or loss on sale of a business or asset, gain or loss related to modification of purchase options, contingent milestone payments associated with acquisitions of legal entities accounted for as asset acquisitions, acquisition-related costs and certain adjustments to income tax expense. These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for, or superior to, the financial measures prepared and presented in accordance with GAAP, and should be reviewed in conjunction with the relevant GAAP financial measures. Please refer to the attached Reconciliation of GAAP to non-GAAP Financial Results for explanations of the amounts adjusted to arrive at non-GAAP net income and non-GAAP earnings per share amounts for the three and twelve month periods ended December 31, 2020 and 2019.
(Tables Follow)
TABLE 1: CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in millions, except per share amounts)
Three months ended Twelve months ended
December 31, December 31,
Net product sales $ 1,591.7 $ 1,384.2 $ 6,069.1 $ 4,990.0
Other revenue 0.1 0.1 0.8 1.1
Total revenues 1,591.8 1,384.3 6,069.9 4,991.1
Costs and expenses:
Cost of sales (exclusive of amortization of purchased intangible assets) 152.2 114.3 553.5 394.5
Research and development 295.0 269.6 1,002.9 886.0
Selling, general and administrative 444.4 381.0 1,399.9 1,261.1
Acquired in-process research and development — — — (4.1)
Amortization of purchased intangible assets 53.2 73.9 253.7 309.6
Change in fair value of contingent consideration 16.2 4.4 61.2 11.6
Acquisition-related costs 11.9 — 117.6 —
Restructuring expenses (3.2) 0.1 10.3 12.0
Impairment of intangible assets — — 2,053.3 —
Gain on sale of asset — — (14.8) —
Total costs and expenses 969.7 843.3 5,437.6 2,870.7
Operating income 622.1 541.0 632.3 2,120.4
Other income and expense:
Investment income, net (3.1) 49.7 44.7 100.3
Interest expense (27.7) (21.7) (104.7) (77.8)
Other income and (expense) (0.7) 33.0 (3.3) 35.9
Income before income taxes 590.6 602.0 569.0 2,178.8
Income tax expense (benefit) 54.8 (287.0) (34.4) (225.5)
Net income $ 535.8 $ 889.0 $ 603.4 $ 2,404.3
Earnings per common share
Basic $ 2.45 $ 4.02 $ 2.74 $ 10.77
Diluted $ 2.42 $ 4.00 $ 2.72 $ 10.70
Shares used in computing earnings per common share
Basic 218.9 221.3 220.1 223.2
Diluted 221.3 222.5 222.0 224.8
TABLE 2: RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS
GAAP net income $ 535.8 $ 889.0 $ 603.4 $ 2,404.3
Before tax adjustments:
Cost of sales:
Share-based compensation 3.1 3.5 12.4 14.2
Fair value adjustment in inventory acquired (1)
11.1 — 22.9 —
Research and development expense:
Share-based compensation 21.0 15.8 68.6 61.7
Upfront payments related to licenses and other strategic agreements (2)
— 27.1 — 103.4
4.2 — 4.9 —
Selling, general and administrative expense:
Share-based compensation 59.8 41.0 179.7 161.1
Litigation charges (3)
— — 21.6 0.1
Change in fair value of contingent consideration (4)
Acquisition-related costs (5)
11.9 — 117.6 —
Restructuring expenses (6)
(3.2) 0.1 10.3 12.0
Impairment of intangible assets (7)
— — 2,053.3 —
Gain on sale of asset (8)
— — (14.8) —
Investment income (expense):
(Gains) and losses related to strategic equity investments(9)
7.6 (39.0) (26.6) (59.7)
Other income and (expense):
Gain related to modification of purchase option(10)
— (32.0) — (32.0)
Adjustments to income tax expense (11)
(56.2) (372.8) (547.2) (584.9)
Non-GAAP net income $ 664.5 $ 611.0 $ 2,821.0 $ 2,397.3
GAAP earnings per common share - diluted $ 2.42 $ 4.00 $ 2.72 $ 10.70
Non-GAAP earnings per common share - diluted $ 2.96 $ 2.71 $ 12.51 $ 10.53
Shares used in computing diluted earnings per common share (GAAP) 221.3 222.5 222.0 224.8
Shares used in computing diluted earnings per common share (non-GAAP) 224.4 225.6 225.5 227.6
(1) During the three months ended December 31, 2020, we recorded $11.1 million and $4.2 million within cost of sales and research and development expense, respectively, related to the amortization of the excess fair value of ANDEXXA inventory over the estimated historical cost basis of the inventory, recognized in connection with the acquisition of Portola Pharmaceuticals, Inc. During the twelve months ended December 31, 2020 we recorded $22.9 million and $4.9 million within cost of sales and research and development expense, respectively.
(2) During the three months ended December 31, 2019, we recorded expense of $27.1 million in connection with upfront payments on strategic agreements that we entered into with Stealth BioTherapeutics Corp. (Stealth) and Immune Pharmaceuticals (Immune Pharma). During the twelve months ended December 31, 2019, we recorded expense of $103.4 million in connection with upfront payments on strategic agreements that we entered into with Stealth, Immune Pharma, Eidos Therapeutics, Inc., Affibody AB, and Zealand Pharma A/S.
(3) During the twelve months ended December 31, 2020, we recorded $21.6 million in litigation charges in connection with legal proceedings.
(4) Changes in the fair value of contingent consideration expense for the three and twelve months ended December 31, 2020 reflect changes in the expected timing and probability of achieving contingent milestone payments and the interest component of contingent consideration related to changes in discount rates and the passage of time. Changes in fair value of contingent consideration expense for the three and twelve months ended December 31, 2019 reflect changes in the expected timing of achieving contingent milestone payments and the interest component of contingent consideration related to the passage of time.
(5) For the three and twelve months ended December 31, 2020, we recorded $11.9 million and $117.6 million, respectively, of acquisition-related costs primarily in connection with the Achillion Pharmaceuticals, Inc. and Portola Pharmaceuticals, Inc. acquisitions. Acquisition-related costs primarily consist of transaction costs, costs associated with the accelerated vesting of equity awards previously granted to employees and employee separation costs.
(6) During the three and twelve months ended December 31, 2020, we recorded a benefit of $3.2 million and expense of $10.3 million, respectively, of restructuring expenses relating to restructuring activities initiated during the third quarter 2020 primarily within our commercial organization.
(7) In the second quarter 2020, we recognized impairment charges of $2,053.3 million, primarily related to our KANUMA intangible asset.
(8) In July 2020, we sold certain intellectual property rights and assets to Inozyme Pharma in exchange for $14.8 million of Inozyme common stock. As a result, we recognized a gain on the sale during the twelve months ended December 31, 2020.
(9) (Gains) and losses related to strategic equity investments include unrealized gains and losses in investment income to adjust our strategic equity investments to fair value. In addition, during the three and twelve months ended December 31, 2020 we recognized an impairment charge of $49.0 million on our option to acquire the remaining equity of Caelum Biosciences (Caelum). In connection with entering into the Merger Agreement with AstraZeneca in December 2020, we determined that the fair value of our option decreased as a result of a change to the expected option exercise date.
(10) In December 2019, we amended the terms our of our agreement with Caelum with respect to the option to acquire the remaining equity in Caelum. In conjunction with this amendment, we recognized a gain of $32.0 million in other income and (expense), which reflects an increase in the fair value of the option, less incremental upfront funding and the change in the fair value of contingent payments which we also modified as a part of amendment.
(11) Alexion's non-GAAP income tax expense for the three and twelve months ended December 31, 2020 and 2019 excludes the tax effect of pre-tax adjustments to GAAP profit. Non-GAAP income tax expense for the three and twelve months ended December 31, 2019 excludes a one-time tax benefit of $382.2 million related to the intra-entity asset transfer of intellectual property within our captive foreign partnership. Non-GAAP income tax expense for the twelve months ended December 31, 2019 also excludes certain one-time tax benefits of $95.7 million and $30.3 million associated with a tax election made with respect to intellectual property of Wilson and a release of an existing valuation allowance, respectively.
TABLE 3: NET PRODUCT SALES BY GEOGRAPHY
SOLIRIS
United States $ 587.4 $ 557.2 $ 2,259.7 $ 2,014.0
Europe 267.6 249.6 1,033.3 1,049.8
Asia Pacific 87.5 94.3 343.0 423.5
Rest of World 81.0 112.0 428.2 459.1
Total SOLIRIS $ 1,023.5 $ 1,013.1 $ 4,064.2 $ 3,946.4
ULTOMIRIS
United States $ 185.7 $ 92.9 $ 646.0 $ 236.8
Europe 58.0 31.1 170.4 52.2
Asia Pacific 69.0 46.2 255.3 49.9
Rest of World 0.8 — 5.0 —
Total ULTOMIRIS $ 313.5 $ 170.2 $ 1,076.7 $ 338.9
STRENSIQ
United States $ 144.8 $ 128.0 $ 562.9 $ 451.7
Europe 19.2 21.0 80.8 77.0
Asia Pacific 16.3 14.4 61.0 50.4
Rest of World 5.6 3.4 27.1 13.4
Total STRENSIQ $ 185.9 $ 166.8 $ 731.8 $ 592.5
ANDEXXA
United States $ 35.5 $ — $ 71.7 $ —
Europe 4.1 — 6.8 —
Asia Pacific — — — —
Rest of World — — — —
Total ANDEXXA $ 39.6 $ — $ 78.5 $ —
KANUMA
United States $ 16.1 $ 14.9 $ 63.7 $ 60.0
Europe 10.2 7.7 35.6 27.1
Asia Pacific 1.4 1.2 4.3 4.6
Rest of World 1.5 10.3 14.3 20.5
Total KANUMA $ 29.2 $ 34.1 $ 117.9 $ 112.2
Net Product Sales
Asia Pacific 174.2 156.1 663.6 528.4
Total Net Product Sales $ 1,591.7 $ 1,384.2 $ 6,069.1 $ 4,990.0
TABLE 4: CONDENSED CONSOLIDATED BALANCE SHEETS
Cash and cash equivalents $ 2,964.5 $ 2,685.5
Marketable securities 34.9 64.0
Trade accounts receivable, net 1,409.3 1,243.2
Prepaid expenses and other current assets 648.6 456.1
Property, plant and equipment, net 1,238.8 1,163.3
Intangible assets, net 3,002.4 3,344.3
Right of use operating assets 223.1 204.0
Deferred tax assets 2,199.4 2,290.2
Total assets $ 18,103.0 $ 17,544.6
Accounts payable and accrued expenses $ 1,203.3 $ 966.7
Current portion of long-term debt 142.4 126.7
Current portion of contingent consideration 114.9 —
Long-term debt, less current portion 2,419.6 2,375.0
Deferred tax liabilities 1,632.2 2,081.4
Contingent consideration 299.4 192.4
Noncurrent operating lease liabilities 177.1 164.1
Total liabilities 6,451.8 6,272.8
Total stockholders' equity 11,651.2 11,271.8
Total liabilities and stockholders' equity $ 18,103.0 $ 17,544.6
TABLE 5: CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS
Year Ended December 31,
Net income $ 603.4 $ 2,404.3
Adjustments to reconcile net income to net cash flows from operating activities:
Depreciation and amortization 329.4 376.8
Impairment of intangible assets 2,053.3 —
Change in fair value of contingent consideration 61.2 11.6
Payments of contingent consideration — (100.0)
Share-based compensation expense 281.1 237.0
Non-cash expense for acquired IPR&D — —
Deferred tax (benefit) expense (283.4) (455.4)
Unrealized foreign currency (gain) loss (5.2) (2.1)
Unrealized loss (gain) on forward contracts 6.4 (16.5)
Unrealized loss (gain) on strategic equity investments 3.0 (26.9)
Gain on sale of strategic equity investments — (32.8)
Gain on sale of asset (14.8) —
Gain on modification of purchase option — (32.0)
Gain on derecognition of Portola strategic equity investment (29.7) —
Inventory obsolescence charge 27.5 3.3
Other 4.5 (2.7)
Changes in operating assets and liabilities, excluding the effect of acquisitions:
Accounts receivable (139.4) (319.2)
Inventories 95.0 (160.2)
Prepaid expenses, right of use operating assets and other assets (111.9) (31.0)
Accounts payable, accrued expenses, lease liabilities and other liabilities 122.5 230.7
Net cash provided by operating activities 3,002.9 2,084.9
Purchases of available-for-sale debt securities (19.4) (80.2)
Proceeds from maturity or sale of available-for-sale debt securities 184.2 222.2
Purchases of mutual funds related to nonqualified deferred compensation plan (19.7) (17.6)
Proceeds from sale of mutual funds related to nonqualified deferred compensation plan 12.1 14.7
Purchases of property, plant and equipment (106.7) (154.7)
Purchases of strategic equity investments and options (38.1) (73.3)
Proceeds from sale of strategic equity investments — 114.7
Payments for acquisitions of businesses, net of cash and restricted cash acquired (2,111.9) —
Purchases of intangible assets — (16.0)
Other — (0.1)
Net cash (used in) provided by investing activities (2,099.5) 9.7
Proceeds from revolving credit facility — —
Payments on revolving credit facility — (250.0)
Payments on term loan (130.6) (98.0)
Repurchase of common stock (510.8) (416.0)
Net proceeds from issuance of stock under share-based compensation arrangements 58.7 29.9
Other (29.2) (5.0)
Net cash used in financing activities (611.9) (739.1)
Effect of exchange rate changes on cash and cash equivalents and restricted cash 19.5 0.8
Net change in cash and cash equivalents and restricted cash 311.0 1,356.3
Cash and cash equivalents and restricted cash at beginning of period $ 2,723.6 $ 1,367.3
Cash and cash equivalents and restricted cash at end of period $ 3,034.6 $ 2,723.6
Alexion Contacts:
Megan Goulart, 857-338-8634
Executive Director, Corporate Communications
Chris Stevo, 857-338-9309
https://last10k.com/sec-filings/report/899866/000089986621000009/alxn-20210204.htm
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Alexion Pharmaceuticals, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2021 10-K Annual Report includes:
Cover Page Statement
Alexion Pharmaceuticals, Inc. provided additional information to their SEC Filing as exhibits
Ticker: ALXN
Period: Thursday, February 4, 2021
Industry: Pharmaceutical Preparations
https://last10k.com/sec-filings/alxn/0000899866-21-000009.htm