- Soliris® (eculizumab) Net
Product Sales Increased 44% to
- Continued Steady Growth of Soliris in PNH -
- aHUS Launch Progresses With New Patients Starting on Soliris -
- Guidance Revised Upward for Revenues and Non-GAAP EPS -
- Encouraging Eculizumab Phase 2 Data in NMO Presented at the ANA Meeting -
Third Quarter 2012 Financial Highlights:
-
Q3 2012 revenues increased 44 percent to
$294.1 million , compared to$204.0 million in Q3 2011 -
Q3 2012 GAAP net income increased 41 percent to
$92.2 million , or$0.46 per share, compared to GAAP net income of$65.6 million , or$0.34 per share, in Q3 2011 -
Q3 2012 non-GAAP net income increased 66 percent to
$120.7 million , or$0.60 per share, compared to non-GAAP net income of$72.6 million , or$0.37 per share, in Q3 2011
Revenue performance for the quarter reflected steady additions of new
patients with paroxysmal nocturnal hemoglobinuria (PNH) commencing
Soliris therapy in Alexion's core territories of the US,
Soliris is approved for patients with PNH in the US (2007),
Alexion's non-GAAP operating results are equal to GAAP operating results adjusted for the impact of share-based compensation, costs associated with acquisitions, taxes that are not payable in cash, taxes related to acquisition structuring, impact of intellectual property settlements and intangible asset impairments. A full reconciliation of non-GAAP results is included later in this press release.
Third Quarter 2012 Non-GAAP Financial Results:
The Company reported non-GAAP net income of
As noted above, non-GAAP EPS in Q3 2012 excludes the
Alexion's non-GAAP operating expenses for Q3 2012 were
Third Quarter 2012 GAAP Financial Results:
Alexion reported GAAP net income of
On a GAAP basis, operating expenses for Q3 2012 were
Balance Sheet:
As of
"In the third quarter, a substantial number of new patients with PNH
started on Soliris in our core territories and new countries, while
Soliris therapy also commenced for a growing number of new patients with
aHUS," said
Research and Development Programs:
Alexion currently has lead development programs underway with five highly innovative therapeutics, including eculizumab (Soliris), which are being investigated across eight severe and ultra-rare disorders beyond PNH and aHUS.
Ultra-Rare Disease Programs With Eculizumab
-
Nephrology: STEC-HUS and Kidney Transplant: Data from the full
cohort of 198 enrolled patients in the Company-sponsored
Shiga -toxin-producing E. coli hemolytic uremic syndrome (STEC-HUS) trial will be presented at theAmerican Society of Nephrology (ASN) meeting onNovember 3rd . Separately, enrollment is ongoing in Company-sponsored, multi-national, living-donor and deceased-donor kidney transplant trials in patients at elevated risk of Acute Humoral Rejection (AHR), also known as antibody mediated rejection. -
Neurology: NMO and MG: Data from the investigator-initiated
Phase 2 clinical trial of eculizumab in severe and relapsing
neuromyelitis optica (NMO) were presented at the
American Neurological Association (ANA) meeting earlier this month. The study met its primary efficacy endpoint with high degrees of both clinical and statistical significance. Clinically and statistically significant improvements were also observed in key secondary endpoints. Separately, Alexion continues to work with investigators to design the next clinical trial to evaluate eculizumab as a treatment for patients with severe and refractory myasthenia gravis (MG).
Ultra-Rare Disease Programs With Highly Innovative Therapeutic Candidates Beyond Eculizumab
- Asfotase Alfa: The natural history study in infants with hypophosphatasia (HPP), an ultra-rare, inherited and life-threatening metabolic disease, is on-going.
- cPMP Replacement Therapy: The Company expects to complete pre-IND toxicology studies in early 2013 required to commence clinical studies in normal volunteers with its cPMP replacement therapy for the treatment of patients with Molybdenum Cofactor Deficiency Type A, a severe, ultra-rare and genetic metabolic disorder that is fatal in newborns.
- ALXN1102/ALXN1103: Enrollment continues in a Phase I study to characterize the mechanism of action and develop initial safety data for ALXN1102 and ALXN1103, intravenous and sub-cutaneous versions, respectively, of one of Alexion's novel complement inhibitors.
- ALXN1007: Enrollment continues in a Phase I study of ALXN1007, a novel anti-inflammatory antibody, to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of this therapeutic candidate in healthy volunteers.
2012 Financial Guidance:
Alexion today announced that it is raising its 2012 revenue guidance
from the previous range of
Conference Call/Web Cast Information:
Alexion will host a conference call/webcast to discuss matters mentioned
in this release. The call is scheduled for today,
About Soliris:
Soliris is a first-in-class terminal complement inhibitor developed from
the laboratory through regulatory approval and commercialization by
Alexion. Soliris is approved in the US,
About Alexion:
[ALXN-E]
This news release contains forward-looking statements, including
statements related to guidance regarding anticipated financial results
for 2012, assessment of the Company's financial position and
commercialization efforts, medical benefits and commercial potential for
Soliris for PNH and aHUS and other potential indications, expansion of
clinical and commercial operations to additional countries, medical and
commercial potential of Alexion's complement-inhibition technology and
other technologies, plans for clinical programs for each of our product
candidates and progress in developing commercial infrastructure.
Forward-looking statements are subject to factors that may cause
Alexion's results and plans to differ from those expected, including for
example, decisions of regulatory authorities regarding marketing
approval or material limitations on the marketing of Soliris for PNH and
aHUS and other potential indications, delays in arranging satisfactory
manufacturing capabilities and establishing commercial infrastructure,
the possibility that results of clinical trials are not predictive of
safety and efficacy results of Soliris in broader patient populations in
the disease studied or other diseases, the risk that acquisitions will
not result in short-term or long-term benefits, the possibility that
current results of commercialization are not predictive of future rates
of adoption of Soliris in PNH, aHUS or other diseases, the risk that
third parties will not agree to license any necessary intellectual
property to Alexion on reasonable terms or at all, the risk that third
party payors (including governmental agencies) will not reimburse or
continue to reimburse for the use of Soliris at acceptable rates or at
all, the risk that estimates regarding the number of patients with PNH,
aHUS or other disorders are inaccurate, and a variety of other risks set
forth from time to time in Alexion's filings with the
In addition to financial information prepared in accordance with
GAAP, this news release also contains non-GAAP financial measures that
we believe, 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. 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 Net Income 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
|
|
||||||||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||
| (in thousands, except per share amounts) | ||||||||||||||||
| (unaudited) | ||||||||||||||||
| Three months ended | Nine months ended | |||||||||||||||
|
|
|
|||||||||||||||
| 2012 | 2011 | 2012 | 2011 | |||||||||||||
| Net product sales | $ | 294,136 | $ | 204,047 | $ | 813,588 | $ | 555,872 | ||||||||
| Cost of sales | 33,186 | 23,369 | 93,067 | 64,342 | ||||||||||||
| Gain on intellectual property settlement | (53,377 | ) | - | (53,377 | ) | - | ||||||||||
| Total cost of sales | (20,191 | ) | 23,369 | 39,690 | 64,342 | |||||||||||
| Research and development | 54,280 | 36,567 | 159,323 | 103,023 | ||||||||||||
| Selling, general and administrative | 89,957 | 77,572 | 272,054 | 221,609 | ||||||||||||
| Impairment of acquired in-process research and development | 26,300 | - | 26,300 | - | ||||||||||||
| Acquisition-related costs | 1,071 | 340 | 19,759 | 11,442 | ||||||||||||
| Total operating expenses | 171,608 | 114,479 | 477,436 | 336,074 | ||||||||||||
| Operating income | 142,719 | 66,199 | 296,462 | 155,456 | ||||||||||||
| Interest and other income (expense) | (1,954 | ) | (522 | ) | (6,165 | ) | 134 | |||||||||
| Income before income taxes | 140,765 | 65,677 | 290,297 | 155,590 | ||||||||||||
| Income tax provision | 48,586 | 107 | 116,446 | 28,445 | ||||||||||||
| Net income | $ | 92,179 | $ | 65,570 | $ | 173,851 | $ | 127,145 | ||||||||
| Earnings per common share | ||||||||||||||||
| Basic | $ | 0.48 | $ | 0.36 | $ | 0.92 | $ | 0.70 | ||||||||
| Diluted | $ | 0.46 | $ | 0.34 | $ | 0.88 | $ | 0.66 | ||||||||
| Shares used in computing earnings per common share | ||||||||||||||||
| Basic | 193,353 | 183,706 | 189,219 | 182,805 | ||||||||||||
| Diluted | 201,142 | 192,161 | 197,635 | 191,267 | ||||||||||||
|
|
|||||||||||||||||
|
RECONCILIATION OF GAAP TO NON-GAAP NET INCOME |
|||||||||||||||||
| (in thousands, except per share amounts) | |||||||||||||||||
| (unaudited) | |||||||||||||||||
| Three months ended | Nine months ended | ||||||||||||||||
|
|
|
||||||||||||||||
| 2012 | 2011 | 2012 |
2011 |
||||||||||||||
| GAAP net income | $ | 92,179 | $ | 65,570 | $ | 173,851 | $ | 127,145 | |||||||||
|
Share-based compensation expense (1) |
14,015 | 11,261 | 40,322 | 34,426 | |||||||||||||
| Acquisition-related costs (2) | 1,071 | 340 | 19,759 | 11,442 | |||||||||||||
| Non-cash taxes (3) | 40,550 | (4,597 | ) | 74,207 | 12,608 | ||||||||||||
| Tax related to acquisition structuring (3) | - | - | 21,812 | - | |||||||||||||
| Gain on intellectual property settlement (4) | (53,377 | ) | - | (53,377 | ) | - | |||||||||||
|
Impairment of acquired in-process research and development asset (5) |
26,300 | - | 26,300 | - | |||||||||||||
| Non-GAAP net income | $ | 120,738 | $ | 72,574 | $ | 302,874 | $ | 185,621 | |||||||||
| Shares used in computing diluted earnings per share (GAAP) | 201,142 | 192,161 | 197,635 | 191,267 | |||||||||||||
| Shares used in computing diluted earnings per share (non-GAAP) | 202,377 | 193,889 | 198,953 | 193,041 | |||||||||||||
| GAAP earnings per share - diluted | $ | 0.46 | $ | 0.34 | $ | 0.88 | $ | 0.66 | |||||||||
| Non-GAAP earnings per share - diluted | $ | 0.60 | $ | 0.37 | $ | 1.52 | $ | 0.96 | |||||||||
| (1) | The following table summarizes the share-based compensation expense for each expense category in our condensed consolidated statements of operations: | ||||||||||||||
| Three months ended | Nine months ended | ||||||||||||||
|
|
|
||||||||||||||
| 2012 | 2011 | 2012 | 2011 | ||||||||||||
| Share-based compensation expense: | |||||||||||||||
| Cost of sales | $ | 664 | $ | 645 | $ | 1,939 | $ | 1,762 | |||||||
| Research and development | 3,643 | 2,511 | 10,373 | 7,489 | |||||||||||
| Selling, general and administrative | 9,708 | 8,105 | 28,010 | 25,175 | |||||||||||
| $ | 14,015 | $ | 11,261 | $ | 40,322 | $ | 34,426 | ||||||||
| (2) | The following table summarizes acquisition-related costs: | ||||||||||||||
| Three months ended | Nine months ended | ||||||||||||||
|
|
|
||||||||||||||
| 2012 | 2011 | 2012 | 2011 | ||||||||||||
|
Acquisition-related costs: |
|||||||||||||||
| Transaction and separation costs | $ | 1,509 | $ | - | $ | 15,114 | $ | 10,047 | |||||||
| Contingent consideration | (542 | ) | 236 | 4,333 | 1,117 | ||||||||||
| Amortization of purchased technology | 104 | 104 | 312 | 278 | |||||||||||
| $ | 1,071 | $ | 340 | $ | 19,759 | $ | 11,442 | ||||||||
| (3) |
Non-cash taxes represent the adjustment for GAAP tax expense that is not payable in cash due to the utilization of our US net operating losses.
In the third quarter of 2011, we elected to claim foreign tax and
orphan drug credits resulting in a tax benefit of
The tax provision for the nine months ended |
|
| (4) |
In |
|
| (5) |
During the three months ended |
|
|
|
||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| (in thousands) | ||||||||
| (unaudited) | ||||||||
|
|
December 31, | |||||||
| 2012 | 2011 | |||||||
| Cash and cash equivalents | $ | 905,526 | $ | 540,865 | ||||
| Trade accounts receivable, net | 311,369 | 244,288 | ||||||
| Inventories, net | 90,049 | 81,386 | ||||||
| Deferred tax assets, current | 19,177 | 19,132 | ||||||
| Other current assets | 84,270 | 55,599 | ||||||
| Property, plant and equipment, net | 165,047 | 165,852 | ||||||
| Deferred tax assets, noncurrent | 14,509 | 103,868 | ||||||
| Intangible assets, net | 648,306 | 91,604 | ||||||
| Goodwill | 253,839 | 79,639 | ||||||
| Other noncurrent assets | 13,516 | 12,518 | ||||||
| Total assets | $ | 2,505,608 | $ | 1,394,751 | ||||
| Accounts payable and accrued expenses | $ | 269,847 | $ |
199,653 |
||||
| Current portion of long-term debt | 48,000 | - | ||||||
| Other current liabilities | 44,095 | 28,132 | ||||||
| Long-term debt | 113,000 | - | ||||||
| Contingent consideration | 139,453 | 18,120 | ||||||
| Other noncurrent liabilities | 18,778 |
14,354 |
||||||
| Total liabilities | 633,173 | 260,259 | ||||||
| Total stockholders' equity | 1,872,435 | 1,134,492 | ||||||
| Total liabilities and stockholders' equity | $ | 2,505,608 | $ | 1,394,751 | ||||
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