Alexion Pharmaceuticals, Inc. (ALXN) 10-Q Quarterly Report October 2019


•	Received 2 recent regulatory approvals - ULTOMIRIS^® (ravulizumab-cwvz) for atypical hemolytic uremic syndrome (aHUS) in the U.S. and SOLIRIS^® (eculizumab) for adults with neuromyelitis optica spectrum disorder (NMOSD) in the EU


•	Announced agreement to acquire Achillion Pharmaceuticals


•	Continued disciplined business development execution with Eidos and Stealth BioTherapeutics collaborations


•	Increased revenues and EPS guidance to reflect strong business and continued growth

BOSTON, October 23, 2019 - Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced financial results for the third quarter of 2019. Total revenues in the third quarter were $1,263.1 million, a 23 percent increase compared to the same period in 2018. The negative impact of foreign currency on total revenues year-over-year was less than 1 percent, or $2.5 million, inclusive of hedging activities. On a GAAP basis, diluted EPS in the quarter was $2.08, a 41 percent increase versus the prior year. Non-GAAP diluted EPS for the third quarter of 2019 was $2.79, a 38 percent increase versus the third quarter of 2018.

"With consistent and strong execution, we have delivered another record performance in the third quarter, building on our momentum from the first half of 2019. Our teams continued to demonstrate launch excellence across the globe, with very rapid starts to the German and Japanese ULTOMIRIS PNH launches, where conversion is progressing ahead of the best-in-class U.S. launch at the same time points, as well as a strong start to the SOLIRIS NMOSD launch in the U.S.," said Ludwig Hantson, Ph.D., Chief Executive Officer of Alexion. "We also continued to expand our portfolio with two additional approvals - ULTOMIRIS for atypical HUS in the U.S. and SOLIRIS for NMOSD in the EU - and three new business development transactions that further diversify our pipeline, including an agreement to acquire Achillion. By continuing to deliver on the ambitious transformation plan we laid out two-and-a-half years ago, we have successfully established a strong foundation for the future and look forward to building on this progress as we advance our mission of delivering life-changing therapies to people with rare diseases."

Third Quarter 2019 Financial Highlights


•	Total net product sales were $1,263.1 million in the third quarter of 2019, compared to $1,026.5 million in the third quarter of 2018.

The following information was filed by Alexion Pharmaceuticals, Inc. (ALXN) on Wednesday, October 23, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside Alexion Pharmaceuticals, Inc.'s 10-Q Quarterly Report:

Financial - Expense Highlight
49 During the third quarter 2019, the U.S. patent term extension to a composition of matter patent for STRENSIQ was granted, which resulted in a change in the estimated useful life of the STRENSIQ intangible asset and will result in lower amortization expense in future periods.Change in Fair Value of Contingent ConsiderationFor the three and nine months ended September 30, 2019, the expense resulting from the change in fair value of contingent consideration associated with our prior business combinations was $29.8 and $7.2, respectively, as compared to $53.5 and $110.9 for the three and nine months ended September 30, 2018.

Other - Other Highlight
Generalized Myasthenia Gravis (gMG) Myasthenia Gravis (MG) is a debilitating, complement-mediated neuromuscular disease in which patients suffer profound muscle weakness throughout the body, resulting in slurred speech, impaired swallowing and choking, double vision, upper and lower extremity weakness, disabling fatigue, shortness of breath due to respiratory muscle weakness and episodes of respiratory failure.
Financial - Cash Flow Highlight
We expect increases in cash flows from operations, which will be highly dependent on sales levels and the related cash collections from sales of our products.
Financial - Expense Highlight
Selling, General and Administrative Expense 2019 Selling General and Administrative Expense (SG&A) 2018 Selling General and Administrative Expense (SG&A) SG&A as a % of net product sales 48 Our selling, general and administrative expense includes commercial and administrative personnel, corporate facility and external costs required to support the marketing and sales of our commercialized products.
Financial - Expense Highlight
Partially offset by the following: Decrease of $10.4 in product development expenses primarily related to a decrease in costs associated with milestone expenses.
Financial - Cash Flow
We anticipate that cash generated...Read more
Other - Other
The increase in cash used...Read more
Financial - Income
Income Taxes 2019 Income Tax...Read more
Financial - Income
50 Other Income and (Expense)...Read more
Financial - Shares
52 Financial Condition, Liquidity and...Read more
Other - Other
However, readers should carefully review...Read more
Financial - Shares
Partially offsetting these increases was...Read more
Financial - Expense
Amortization of Purchase Intangible Assets...Read more
Financial - Income
These tax benefits decreased the...Read more
Financial - Shares
As of October 21, 2019,...Read more
Revenue - Geography
To date, we have not...Read more
Revenue - Product
The increase in cash used...Read more
Revenue - Product
This increase was offset by...Read more
Other - Other
In January 2019 we paid...Read more
Financial - Expense
Accordingly, the value of the...Read more
M & A - Other
The increase in cash was...Read more
Financial - Income
The income tax expense for...Read more
Financial - Expense
The remaining change in the...Read more
Financial - Shares
On October 22, 2019, the...Read more
Financial - Expense
Clinical development costs are comprised...Read more
Other - Other
The agreement with Affibody was...Read more
M & A - Other
Alexion's acquisition of Achillion is...Read more
Financial - Expense
These selling, general and administrative...Read more
Financial - Shares
The nine months ended September...Read more
Other - Other
The deferred tax benefits include...Read more
Financial - Expense
Other R&D expenses consist of...Read more
M & A - Other
Excluding the impact of any...Read more
Financial - Shares
The agreement also provides for...Read more
Financial - Expense
Increase in external selling, general...Read more
Revenue - Product
This increase in unit volumes...Read more
Other - Other
We operate in certain jurisdictions...Read more
Other - Other
The increase was primarily related...Read more
Revenue - Product
43 Net Product Sales Net...Read more
Other - Other
Increase of $14.6 in payroll...Read more
Other - Other
Increase of $27.6 in payroll...Read more
M & A - Other
Acquired In-Process Research and Development...Read more
Financial - Shares
Under the terms of the...Read more
Financial - Earnings
To the extent CFC earnings...Read more
Other - Other
We cannot guarantee that results...Read more
Revenue - Product
We believe the judgments, estimates...Read more

Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Material Contracts, Statements, Certifications & more

Alexion Pharmaceuticals, Inc. provided additional information to their SEC Filing as exhibits

Exhibit 10.1: Material Contract

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 31.2: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32.1: Section 1350 Certification

Exhibit 32.2: Section 1350 Certification

Ticker: ALXN
CIK: 899866
Form Type: 10-Q Quarterly Report
Accession Number: 0000899866-19-000099
Submitted to the SEC: Wed Oct 23 2019 3:56:30 AM EST
Accepted by the SEC: Wed Oct 23 2019
Period: Monday, September 30, 2019
Industry: Pharmaceutical Preparations