Site icon pharmaceutical daily

Alexion Reports Third Quarter 2020 Results

BOSTON–(BUSINESS WIRE)–Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced financial results for the third quarter of 2020. Total revenues in the third quarter were $1,588.7 million, a 26 percent increase compared to the same period in 2019. The negative impact of foreign currency on total revenues year-over-year was 2 percent, or $25.5 million, inclusive of hedging activities. (Read more…) On a GAAP basis, diluted EPS in the quarter was $2.62, compared to $2.08 in the prior year. Non-GAAP diluted EPS for the third quarter of 2020 was $3.24, a 16 percent increase versus the third quarter of 2019.

“We have continued to build on our momentum from the first half of the year, delivering another strong quarter despite the ongoing challenges and uncertainty surrounding COVID-19. In the third quarter, we further progressed our LEAD-EXPAND-DIVERSIFY strategy with multiple regulatory approvals, the initiation of new Phase 3 trials and the integration of the Portola team,” said Ludwig Hantson, Ph.D., Chief Executive Officer of Alexion. “Our foundation for the future is stronger than ever, and by maintaining our focus on serving patients and delivering for shareholders, I am confident that we will continue to build on our success to date and further advance our mission of delivering life-changing therapies to people with rare diseases and devastating conditions.”

Third Quarter 2020 Financial Highlights

COVID-19

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.

Research and Development

PHASE 3/4

PHASE 1/2

2020 Financial Guidance

Alexion is increasing full year 2020 financial guidance. Full guidance updates are outlined below.

 

Previous

Updated

Total revenues

$5,550 to $5,600 million

$5,900 to $5,950 million

SOLIRIS/ULTOMIRIS revenues

$4,725 to $4,755 million

$5,000 to $5,035 million

Metabolic revenues

$785 to $800 million

$835 to $845 million

ANDEXXA revenues

$40 to $45 million

$65 to $70 million

R&D (% total revenues)

 

 

GAAP

18.1% to 19.2%

17.2% to 18.3%

Non-GAAP

16.5% to 17.5%

16.0% to 17.0%

SG&A (% total revenues)

 

 

GAAP

24.5% to 25.7%

22.6% to 23.8%

Non-GAAP

21.0% to 22.0%

19.5% to 20.5%

Operating margin

 

 

GAAP

3.8% to 5.4%

7.2% to 8.8%

Non-GAAP

53.0% to 54.0%

54.5% to 55.5%

Earnings per share

 

 

GAAP

$0.96 to $1.30

$1.78 to $2.13

Non-GAAP

$10.65 to $10.95

$11.70 to $12.00

Updated 2020 financial guidance assumes a GAAP effective tax rate of (5.0) to (4.5) percent and a non-GAAP effective tax rate of 15.5 to 16.0 percent. The 2020 GAAP and non-GAAP tax rates do not benefit from one-time events that benefited the tax rates in 2019.

Alexion’s financial guidance is based on current foreign exchange rates net of hedging activities and does not include the effect of acquisitions, license and other strategic agreements, intangible asset impairments, litigation charges, changes in fair value of contingent consideration, gains or losses related to strategic equity investments or restructuring and related activity outside of the previously announced activities that may occur after the issuance of this press release.

Conference Call/Webcast Information:

Alexion will host a conference call/audio webcast to discuss the third quarter 2020 results today at 8:00 a.m. Eastern Time. To participate in the call, dial 866-762-3111 (USA) or 210-874-7712 (International), conference ID 6582445 shortly before 8:00 a.m. Eastern Time. A replay of the call will be available for a limited period following the call. The audio webcast can be accessed on the Investor page of Alexion’s website at: http://ir.alexion.com.

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]

Forward-Looking Statement

This press release contains forward-looking statements, including statements related to: guidance regarding anticipated financial results for 2020 (and the assumptions related to such guidance); our expectations regarding the affects COVID-19 will have on our business and operations, including clinical trials and product supply; the strength of our business and continued growth; the Company’s capital allocation strategy; plans to expand the Company’s pipeline; future plans for, and the timing for, the commencement of future clinical trials and the expected timing of the receipt of results of certain clinical trials and studies, including clinical programs for ULTOMIRIS, a higher concentration formulation of ULTOMIRIS, a subcutaneous administration of ULTOMIRIS, SOLIRIS, ALXN1840, CAEL-101, ALXN2060, ALXN2040, ALXN2050, ALXN1720, ALXN1830, ANDEXXA and CERDULATINIB; potential benefits of current products and products under development and in clinical trials; plans for development programs with third parties; and Alexion’s future clinical, regulatory, and commercial plans for ULTOMIRIS and other products and product candidates. Forward-looking statements are subject to factors that may cause Alexion’s results and plans to differ materially from those forward-looking statements, including for example: our dependence on sales from our principal product (SOLIRIS); our ability to facilitate the timely conversion from SOLIRIS to ULTOMIRIS; payer, physician and patient acceptance of ULTOMIRIS as an alternative to SOLIRIS; the impact of the COVID-19 pandemic on Alexion’s business, including its sales, clinical trials, operations and supply chain; appropriate pricing for ULTOMIRIS; future competition from biosimilars and novel products; decisions of regulatory authorities regarding the adequacy of our research, marketing approval or material limitations on the marketing of our products; delays or failure of product candidates to obtain regulatory approval; delays or the inability to launch product candidates due to regulatory restrictions, anticipated expense or other matters; interruptions or failures in the manufacture and supply of our products and our product candidates; failure to satisfactorily address matters raised by the FDA and other regulatory agencies; results in early stage clinical trials may not be indicative of full results or results from later stage or larger clinical trials (or broader patient populations) and do not ensure regulatory approval; the possibility that results of clinical trials are not predictive of safety and efficacy and potency of our products (or we fail to adequately operate or manage our clinical trials) which could cause us to halt trials, delay or prevent us from making regulatory approval filings or result in denial of approval of our product candidates; unexpected delays in clinical trials; unexpected concerns that may arise from additional data or analysis obtained during clinical trials; future product improvements may not be realized due to expense or feasibility or other factors; uncertainty of long-term success in developing, licensing or acquiring other product candidates or additional indications for existing products; inability to complete planned acquisitions due to failure of regulatory approval or material changes in target or otherwise; inability to complete acquisitions and investments due to increased competition for technology; the possibility that current rates of adoption of our products are not sustained; the adequacy of our pharmacovigilance and drug safety reporting processes; failure to protect and enforce our data, intellectual property and proprietary rights and the risks and uncertainties relating to intellectual property claims, lawsuits and challenges against us (including intellectual property lawsuits relating to ULTOMIRIS brought by third parties against Alexion and inter partes review petitions submitted by third parties); the risk that third party payors (including governmental agencies) will not reimburse or continue to reimburse for the use of our products at acceptable rates or at all; failure to realize the benefits and potential of investments, collaborations, licenses and acquisitions, including the acquisition of Portola Pharmaceuticals, Inc.; the possibility that expected tax benefits will not be realized or that potential tax liabilities exceed current expectations; assessment of impact of recent accounting pronouncements; potential declines in sovereign credit ratings or sovereign defaults in countries where we sell our products; delay of collection or reduction in reimbursement due to adverse economic conditions or changes in government and private insurer regulations and approaches to reimbursement; uncertainties surrounding legal proceedings, company investigations and government investigations; the risk that estimates regarding the number of patients with PNH, aHUS, gMG, NMOSD, HPP and LAL-D and other indications we are pursuing are inaccurate; the risks of changing foreign exchange rates; risks relating to the potential effects of the Company’s restructuring; risks related to the acquisition of companies and co-development and collaboration efforts; and a variety of other risks set forth from time to time in Alexion’s filings with the SEC, including but not limited to the risks discussed in Alexion’s Quarterly Report on Form 10-Q for the period ended June 30, 2020 and in our other filings with the SEC. Alexion disclaims any obligation to update any of these forward-looking statements to reflect events or circumstances after the date hereof, except when a duty arises under law.

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 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 Reconciliations of GAAP to non-GAAP Financial Results and GAAP to non-GAAP 2020 Financial Guidance for explanations of the amounts adjusted to arrive at non-GAAP net income and non-GAAP earnings per share amounts for the three and nine month periods ended September 30, 2020 and 2019 and projected twelve months ending December 31, 2020.

(Tables Follow)

 

ALEXION PHARMACEUTICALS, INC.

TABLE 1: CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in millions, except per share amounts)

(unaudited)

 

 

 

 

 

Three months ended

 

Nine months ended

 

September 30,

 

September 30,

 

2020

 

2019

 

2020

 

2019

Net product sales

$

1,588.3

 

 

$

1,263.1

 

 

$

4,477.4

 

 

$

3,605.8

 

Other revenue

0.4

 

 

 

 

0.7

 

 

1.0

 

Total revenues

1,588.7

 

 

1,263.1

 

 

4,478.1

 

 

3,606.8

 

Costs and expenses:

 

 

 

 

 

 

 

Cost of sales (exclusive of amortization of purchased intangible assets)

144.7

 

 

95.2

 

 

401.3

 

 

280.2

 

Research and development

285.9

 

 

232.9

 

 

707.9

 

 

616.4

 

Selling, general and administrative

334.2

 

 

299.3

 

 

955.5

 

 

880.1

 

Acquired in-process research and development

 

 

 

 

 

 

(4.1)

 

Acquisition-related costs

63.0

 

 

 

 

105.7

 

 

 

Restructuring expenses

14.3

 

 

0.3

 

 

13.5

 

 

11.9

 

Change in fair value of contingent consideration

23.4

 

 

29.8

 

 

45.0

 

 

7.2

 

Amortization of purchased intangible assets

53.1

 

 

75.6

 

 

200.5

 

 

235.7

 

Impairment of intangible assets

 

 

 

 

2,053.3

 

 

 

Gain on sale of asset

(14.8)

 

 

 

 

(14.8)

 

 

 

Total costs and expenses

903.8

 

 

733.1

 

 

4,467.9

 

 

2,027.4

 

Operating income

684.9

 

 

530.0

 

 

10.2

 

 

1,579.4

 

Other income and expense:

 

 

 

 

 

 

 

Investment income, net

11.5

 

 

23.0

 

 

47.8

 

 

50.6

 

Interest expense

(27.6)

 

 

(17.9)

 

 

(77.0)

 

 

(56.1)

 

Other income and (expense)

(1.9)

 

 

0.4

 

 

(2.6)

 

 

2.9

 

Income (loss) before income taxes

666.9

 

 

535.5

 

 

(21.6)

 

 

1,576.8

 

Income tax expense (benefit)

88.8

 

 

67.9

 

 

(89.2)

 

 

61.5

 

Net income

$

578.1

 

 

$

467.6

 

 

$

67.6

 

 

$

1,515.3

 

Earnings per common share

 

 

 

 

 

 

 

Basic

$

2.64

 

 

$

2.09

 

 

$

0.31

 

 

$

6.77

 

Diluted

$

2.62

 

 

$

2.08

 

 

$

0.30

 

 

$

6.72

 

Shares used in computing earnings per common share

 

 

 

 

 

 

 

Basic

219.1

 

 

223.3

 

 

220.4

 

 

223.8

 

Diluted

220.6

 

 

224.5

 

 

221.9

 

 

225.4

 

Contacts

Media
Megan Goulart, 857-338-8634

Executive Director, Corporate Communications

Investors
Chris Stevo, 857-338-9309

Head of Investor Relations

Read full story here

Exit mobile version