Lilly Reports Third-Quarter 2014 Results
- Third-quarter 2014 revenue declined 16 percent driven by the impact of U.S. patent expirations for Cymbalta and Evista, partially offset by volume growth in most other products.
- Reported operating expenses declined 4 percent as ongoing cost containment initiatives were partially offset by expense associated with the U.S. Branded Prescription Drug Fee and costs related with the termination of development for tabalumab. Non-GAAP operating expenses declined 8 percent.
- Third-quarter 2014 earnings per share were
$0.47 on a reported basis and$0.66 on a non-GAAP basis. - Clinical pipeline advancements during the third quarter included 3
FDA approvals and several positive Phase III data readouts. - 2014 reported EPS guidance range revised to be
$2.34 to$2.42 ; non-GAAP EPS guidance range reaffirmed at$2.72 to$2.80 .
$ in millions, except per share data |
Third Quarter |
% | ||||||
2014 |
2013 |
Change | ||||||
Total Revenue - Reported |
$ |
4,875.6 |
$ |
5,772.6 |
(16)% | |||
Net Income - Reported |
500.6 |
1,203.1 |
(58)% | |||||
EPS - Reported |
0.47 |
1.11 |
(58)% | |||||
Net Income - non-GAAP |
706.6 |
1,203.1 |
(41)% | |||||
EPS - non-GAAP |
0.66 |
1.11 |
(41)% | |||||
Certain financial information for 2014 and 2013 is presented on both a reported and a non-GAAP basis. Some numbers in this press release may not add due to rounding. Reported results were prepared in accordance with generally accepted accounting principles (GAAP) and include all revenue and expenses recognized during the period. Non-GAAP measures exclude the items described in the reconciliation tables later in the release. The non-GAAP measures are presented in order to provide additional insights into the underlying trends in the company's business. The company's 2014 financial guidance is also being provided on both a reported and a non-GAAP basis.
"While Lilly's third-quarter financial results continue to reflect the impact of recent patent expirations, our clinical pipeline is now producing strong momentum to drive future growth," said
Key Events Over the Last Three Months
The U.S. Food and Drug Administration (FDA) approved Jardiance® (empagliflozin) tablets as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Jardiance is part of the company's strategic diabetes collaboration with Boehringer Ingelheim. The companies have launched Jardiance in the U.S. and certain European countries.- The
FDA approved Trulicity™ (dulaglutide) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The company is launching Trulicity in the U.S. in the fourth quarter of 2014. In addition, theCommittee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval of Trulicity to improve glycemic control in adults with type 2 diabetes as monotherapy or in combination with other diabetes medicines, including insulin. - The
FDA granted tentative approval for Basaglar™ (insulin glargine injection), a basal insulin product being developed in collaboration with Boehringer Ingelheim. TheFDA has determined that Basaglar meets all of the regulatory requirements for approval, but it is subject to an automatic stay of up to 30 months as a result of litigation filed by Sanofi, claiming patent infringement. In addition, theEuropean Commission granted marketing authorization for this insulin glargine product, indicated to treat diabetes in adults, adolescents and children aged 2 years and above. Lilly and Boehringer Ingelheim will launch the insulin glargine product based on dates that do not infringe valid and enforceable patents. - The company announced that its investigational medicine ixekizumab was statistically superior to etanercept and placebo on all skin clearance measures in Phase III studies in moderate-to-severe plaque psoriasis. Lilly is on track to file a submission with regulatory authorities by the end of the first half of 2015.
- The company announced that its investigational basal insulin peglispro demonstrated a statistically significant lower hemoglobin A1c compared with insulin glargine at 26 weeks and 52 weeks, respectively, in Phase III clinical trials in patients with type 1 diabetes. Lilly is on track to file submissions with regulatory authorities by the end of the first quarter in 2015.
- The company announced a Phase III study of Cyramza® in combination with chemotherapy in patients with metastatic colorectal cancer met its primary endpoint of overall survival. The company expects to initiate regulatory submissions in the first half of 2015.
- The company submitted Cyramza to the
FDA as a treatment for second-line non-small cell lung cancer. The company expects regulatory action by the end of 2014. - The CHMP issued a positive opinion recommending approval for Cyramza in adults in combination with paclitaxel for the treatment of advanced gastric (stomach) or gastroesophageal junction adenocarcinoma following prior chemotherapy and as a monotherapy in this setting for patients for whom treatment in combination with paclitaxel is not appropriate. The company has also submitted Cyramza for the treatment of second line gastric cancer in
Japan and was granted priority review. - The company and AstraZeneca announced an agreement to co-develop and commercialize AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in development as a potential treatment for Alzheimer's disease.
- The company announced it will discontinue development of tabalumab -- being studied for the treatment of systemic lupus erythematosus (SLE, commonly known as lupus) and multiple myeloma.
- The feed additives business acquired from
Lohmann Animal Health in the second quarter of 2014 was sold as planned to a Lohmann management-led group. - The company recorded a
$119 million non-tax deductible charge in the third quarter of 2014 due to a change created by theIRS final regulations in regard to its administration of the U.S. Branded Prescription Drug Fee. Final regulations modified the timing of when the company must recognize the expense. In addition to accounting for the fee that was imposed and paid in 2014, the company must now also accrue in 2014 for the fee that will be imposed and paid in 2015. - In October the company made the decision and announced plans to close and sell one of its three manufacturing plants located in
Puerto Rico . As a result of this action, the company expects to record a charge of approximately$170 million (pre-tax) or approximately$0.16 per share (after tax) in the fourth-quarter of 2014. - The company announced the expansion of its existing licensing and collaboration agreement with
Zymeworks Inc. The company will expand the collaboration to include development of additional targets, specifically focused on immuno-modulatory bi-specific antibodies.
Third-Quarter Reported Results
In the third quarter of 2014, worldwide total revenue was
Gross margin decreased 21 percent to
Total operating expenses in the third quarter of 2014, defined as the sum of research and development and marketing, selling and administrative expenses, were
In the third quarter of 2014, the company recognized acquired in-process research and development charges totaling
In the third quarter of 2014, the company recognized asset impairment, restructuring and other special charges of
Operating income in the third quarter of 2014 was
Other income (expense) was income of
The effective tax rate was 23.6 percent in the third quarter of 2014, compared with 20.5 percent in the third quarter of 2013. The effective tax rate for the third quarter of 2014 includes the negative impact of the expiration of the R&D tax credit in the U.S. at the end of 2013.
In the third quarter of 2014, net income and earnings per share decreased 58 percent to
Third-Quarter 2014 Non-GAAP Measures
On a non-GAAP basis, operating income decreased
Non-GAAP measures exclude items totaling
Third Quarter |
||||
2014 |
2013 |
% Growth | ||
Earnings per share (reported) |
|
|
(58)% | |
Branded Prescription Drug Fee |
.11 |
- |
||
Acquired in-process research and development charges associated with |
.06 |
- |
||
Asset impairment, restructuring and other special charges |
.02 |
- |
||
Earnings per share (non-GAAP) |
|
|
(41)% |
Year-to-Date Results
For the first nine months of 2014, worldwide total revenue was
Non-GAAP measures exclude items totaling
Year-to-Date |
||||
2014 |
2013 |
% Growth | ||
Earnings per share (reported) |
|
|
(50)% | |
Branded Prescription Drug Fee |
.11 |
- |
||
Acquired in-process research and development charges associated with |
.06 |
- |
||
Asset impairment, restructuring and other special charges |
.04 |
.06 |
||
Income related to the termination of the exenatide collaboration with Amylin |
- |
(.29) |
||
Earnings per share (non-GAAP) |
|
|
(40)% |
Numbers do not add due to rounding.
Revenue Highlights |
||||||||||||||||||
(Dollars in millions) |
Third Quarter |
% Change |
Year-to-Date |
% Change | ||||||||||||||
2014 |
2013 |
2013 |
2014 |
2013 |
2013 | |||||||||||||
Alimta® |
$ |
723.4 |
$ |
690.5 |
5% |
$ |
2,067.0 |
$ |
1,976.8 |
5% | ||||||||
Humalog® |
706.1 |
616.0 |
15% |
2,056.1 |
1,877.4 |
10% | ||||||||||||
Cialis® |
568.4 |
526.7 |
8% |
1,668.6 |
1,571.1 |
6% | ||||||||||||
Cymbalta |
368.0 |
1,375.8 |
(73)% |
1,247.5 |
4,201.2 |
(70)% | ||||||||||||
Humulin® |
335.9 |
307.0 |
9% |
1,004.5 |
946.3 |
6% | ||||||||||||
Forteo® |
332.2 |
306.7 |
8% |
941.2 |
885.2 |
6% | ||||||||||||
Zyprexa® |
257.4 |
278.7 |
(8)% |
784.2 |
846.7 |
(7)% | ||||||||||||
Strattera® |
191.9 |
173.2 |
11% |
543.7 |
508.1 |
7% | ||||||||||||
Effient® |
131.5 |
124.9 |
5% |
384.4 |
378.1 |
2% | ||||||||||||
Evista |
89.5 |
255.3 |
(65)% |
347.8 |
774.6 |
(55)% | ||||||||||||
|
584.7 |
530.3 |
10% |
1,713.3 |
1,573.1 |
9% | ||||||||||||
Total Revenue |
$ |
4,875.6 |
$ |
5,772.6 |
(16)% |
$ |
14,494.3 |
$ |
17,304.3 |
(16)% |
Alimta
For the third quarter of 2014, Alimta generated sales of
Humalog
For the third quarter of 2014, worldwide Humalog sales increased 15 percent, to
Cialis
Cialis sales for the third quarter of 2014 increased 8 percent to
Cymbalta
For the third quarter of 2014, Cymbalta generated
Humulin
Worldwide Humulin sales increased 9 percent in the third quarter of 2014, to
Forteo
Third-quarter 2014 sales of Forteo were
Zyprexa
In the third quarter of 2014, Zyprexa sales totaled
Strattera
During the third quarter of 2014, Strattera generated
Effient
Effient sales were
Evista
Evista sales for the third quarter of 2014 decreased 65 percent to
In the third quarter of 2014, worldwide animal health sales totaled
2014 Financial Guidance
The company has revised certain elements of its 2014 financial guidance. Full-year 2014 earnings per share are now expected to be in the range of
2014 Expectations |
2013 Results |
% Change | |||
Earnings per share (reported) |
|
|
(46)% to (44)% | ||
Asset impairment, restructuring and other special charges |
.20 |
.08 |
|||
U.S. Branded Prescription Drug Fee |
.11 |
- |
|||
Income related to termination of the exenatide collaboration with Amylin |
- |
(.29) |
|||
Acquired in-process research and development charges associated with |
.06 |
.03 |
|||
Earnings per share (non-GAAP) |
|
|
(34)% to (33)% |
Numbers do not add due to rounding.
Due to the strengthening of the U.S. Dollar, as well as competitive pressures and market dynamics in the U.S. animal health business, the company now anticipates 2014 revenue between
The company now anticipates gross margin as a percent of revenue will be approximately 74.5 percent in 2014 driven by recent strengthening of the U.S. Dollar versus the Euro. Gross margin in 2014 is now also expected to benefit from a decision to delay until 2015 the shutdown at one of the company's bulk insulin plants to implement production changes.
Total operating expenses in 2014 are still expected to decrease substantially compared to 2013. On a reported basis marketing, selling and administrative expenses are now expected in the range of
Other income (expense) is now expected to be in the range of
The 2014 tax rate is now expected to be approximately 20 percent, on a reported basis and still expected to be approximately 19 percent on a non-GAAP basis. These tax rates assume a full-year 2014 benefit of the R&D tax credit and other tax provisions up for extension. If these items are not extended, both 2014 tax rates would be approximately 2 percentage points higher.
The company now expects 2014 net income to be at least
The company's 2014 financial guidance assumes that the acquisition of
The following table summarizes revisions to the company's 2014 financial guidance.
2014 Guidance | |||
Prior |
Revised | ||
Total Revenue |
|
| |
Gross Margin % of Revenue |
Approx. 73% |
Approx. 74.5% | |
Marketing, Selling & Admin (reported) |
|
| |
Marketing, Selling & Admin (non-GAAP) |
|
| |
Research & Development |
|
| |
Other Income/(Expense) |
|
| |
Tax Rate (reported) |
Approx. 19% |
Approx. 20% | |
Tax Rate (non-GAAP) |
Approx. 19% |
Approx. 19% | |
Minimum Net Income (reported) |
|
| |
Minimum Net Income (Non-GAAP) |
|
| |
Earnings per Share (reported) |
|
| |
Earnings per Share (non-GAAP) |
|
| |
Minimum Operating Cash Flow |
|
| |
Capital Expenditures |
Approx. |
Approx. |
Webcast of Conference Call
As previously announced, investors and the general public can access a live webcast of the third-quarter 2014 financial results conference call through a link on Lilly's website at www.lilly.com. The conference call will be held today from
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and voluntarism. To learn more about Lilly, please visit us at www.lilly.com and http://newsroom.lilly.com/social-channels. F-LLY
This press release contains management's current intentions and expectations for the future, all of which are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The words "estimate", "project", "intend", "expect", "believe", "target" and similar expressions are intended to identify forward-looking statements. Actual results may differ materially due to various factors. There are significant risks and uncertainties in pharmaceutical research and development. There can be no guarantees with respect to pipeline products that the products will receive the necessary clinical and manufacturing regulatory approvals or that they will prove to be commercially successful. Pharmaceutical products can develop unexpected safety or efficacy concerns. The company's results may also be affected by such
factors as the timing of anticipated regulatory approvals and launches of new products; market uptake of recently launched products; competitive developments affecting current products; the expiration of intellectual property protection for certain of the company's products; the company's ability to protect and enforce patents and other intellectual property; the impact of governmental actions regarding pricing, importation, and reimbursement for pharmaceuticals, including U.S. health care reform; regulatory compliance problems or government investigations; regulatory actions regarding currently marketed products; unexpected safety or efficacy concerns associated with the company's products; issues with product supply stemming from manufacturing difficulties or disruptions; regulatory changes or other developments; changes in patent law or regulations related to data-package exclusivity;
litigation involving current or future products; the extent to which third party indemnification obligations relating to product liability litigation and similar matters will be performed; unauthorized disclosure of trade secrets or other confidential data stored in the company's information systems and networks; changes in tax law and regulations; changes in inflation, interest rates, and foreign currency exchange rates; asset impairments and restructuring charges; changes in accounting standards promulgated by the
Alimta® (pemetrexed, Lilly)
BasaglarTM (insulin glargine injection, Lilly)
Cialis® (tadalafil, Lilly)
Cymbalta® (duloxetine hydrochloride, Lilly)
Cyramza® (ramucirumab, Lilly)
Effient® (prasugrel, Lilly)
Evista® (raloxifene hydrochloride, Lilly)
Forteo® (teriparatide of recombinant DNA origin injection, Lilly)
Humalog® (insulin lispro injection of recombinant DNA origin, Lilly)
Humulin® (human insulin of recombinant DNA origin, Lilly)
Jardiance® (empagliflozin, Boehringer Ingelheim)
Strattera® (atomoxetine hydrochloride, Lilly)
Trajenta® (linagliptin, Boehringer Ingelheim)
TrulicityTM (dulaglutide,
Lilly)
Zyprexa® (olanzapine, Lilly)
| ||
|
| |
Worldwide Employees |
39,510* |
37,925 |
* Employment totals as of |
| |||||||||||||||||||||||||||||||||
Operating Results (Unaudited) - REPORTED | |||||||||||||||||||||||||||||||||
(Dollars in millions, except per share data) | |||||||||||||||||||||||||||||||||
Three Months Ended |
Nine Months Ended | ||||||||||||||||||||||||||||||||
|
| ||||||||||||||||||||||||||||||||
2014 |
2013 |
% Chg. |
2014 |
2013 |
% Chg. | ||||||||||||||||||||||||||||
Total revenue |
$ |
4,875.6 |
$ |
5,772.6 |
(16)% |
$ |
14,494.3 |
$ |
17,304.3 |
(16)% | |||||||||||||||||||||||
Cost of sales |
1,267.0 |
1,198.1 |
6% |
3,679.4 |
3,521.6 |
4% | |||||||||||||||||||||||||||
Research and development |
1,243.2 |
1,377.4 |
(10)% |
3,547.9 |
4,055.9 |
(13)% | |||||||||||||||||||||||||||
Marketing, selling and administrative |
1,672.1 |
1,652.4 |
1% |
4,820.9 |
5,172.0 |
(7)% | |||||||||||||||||||||||||||
Acquired in-process research |
95.0 |
— |
NM |
95.0 |
— |
NM | |||||||||||||||||||||||||||
Asset impairment, restructuring and other special charges |
36.3 |
— |
NM |
67.7 |
85.2 |
(21)% | |||||||||||||||||||||||||||
Operating income |
562.0 |
1,544.7 |
(64)% |
2,283.4 |
4,469.6 |
(49)% | |||||||||||||||||||||||||||
Net interest income (expense) |
(9.3) |
(7.6) |
(14.6) |
(34.9) |
|||||||||||||||||||||||||||||
Other income - Special |
— |
— |
— |
495.4 |
|||||||||||||||||||||||||||||
Net other income (expense) |
102.8 |
(23.7) |
217.9 |
49.3 |
|||||||||||||||||||||||||||||
Other income (expense) |
93.5 |
(31.3) |
NM |
203.3 |
509.8 |
(60)% | |||||||||||||||||||||||||||
Income before income taxes |
655.5 |
1,513.4 |
(57)% |
2,486.7 |
4,979.4 |
(50)% | |||||||||||||||||||||||||||
Income taxes |
154.9 |
310.3 |
(50)% |
524.7 |
1,022.1 |
(49)% | |||||||||||||||||||||||||||
Net income |
$ |
500.6 |
$ |
1,203.1 |
(58)% |
$ |
1,962.0 |
$ |
3,957.3 |
(50)% | |||||||||||||||||||||||
Earnings per share - diluted |
$ |
0.47 |
$ |
1.11 |
(58)% |
$ |
1.82 |
$ |
3.64 |
(50)% | |||||||||||||||||||||||
Dividends paid per share |
$ |
0.49 |
$ |
0.49 |
0% |
$ |
1.47 |
$ |
1.47 |
0% | |||||||||||||||||||||||
Weighted-average shares outstanding (thousands) - diluted |
1,074,386 |
1,084,257 |
1,075,740 |
1,086,692 |
|||||||||||||||||||||||||||||
NM - not meaningful
|
||||||||||||||||||
Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited) |
||||||||||||||||||
(Dollars in millions, except per share data) |
||||||||||||||||||
Three Months Ended |
Three Months Ended | |||||||||||||||||
GAAP |
Adjustments |
Non-GAAP |
GAAP |
Adjustments |
Non-GAAP | |||||||||||||
Total revenue |
$ |
4,875.6 |
$ |
— |
$ |
4,875.6 |
$ |
5,772.6 |
$ |
— |
$ |
5,772.6 |
||||||
Cost of sales |
1,267.0 |
— |
1,267.0 |
1,198.1 |
— |
1,198.1 |
||||||||||||
Operating expenses(b) (c) |
2,915.3 |
(119.0) |
2,796.2 |
3,029.8 |
— |
3,029.8 |
||||||||||||
Acquired in-process research and development(c) |
95.0 |
(95.0) |
— |
— |
— |
— |
||||||||||||
Asset impairment, restructuring and other special charges(c) |
36.3 |
(36.3) |
— |
— |
— |
— |
||||||||||||
Other income (expense) |
93.5 |
— |
93.5 |
(31.3) |
— |
(31.3) |
||||||||||||
Income taxes |
154.9 |
44.4 |
199.3 |
310.3 |
— |
310.3 |
||||||||||||
Net income |
$ |
500.6 |
206.0 |
$ |
706.6 |
$ |
1,203.1 |
— |
$ |
1,203.1 |
||||||||
Earnings per share - diluted
|
$ |
0.47 |
0.19 |
$ |
0.66 |
$ |
1.11 |
— |
$ |
1.11 |
Numbers do not add due to rounding. | |
(a) |
The company uses non-GAAP financial measures that differ from financial statements reported in conformity with U.S. generally accepted accounting principles (GAAP). The items that are excluded when non-GAAP measures or expectations provided are typically highly variable, difficult to predict, and of a size that could have a substantial impact on the company's reported operations for a period. The company believes that these non-GAAP measures provide useful information to investors. Among other things, they may help investors evaluate the company's ongoing operations. They can assist in making meaningful period-over-period comparisons and in identifying operating trends that would otherwise be masked or distorted by the items subject to the adjustments. Management uses these non-GAAP measures internally to evaluate the performance of the business, including to allocate resources and to evaluate results relative to incentive compensation targets. Investors should consider these non-GAAP measures in addition to, not as a substitute for or superior to, measures of financial performance prepared in accordance with GAAP. |
(b) |
Operating expenses include research and development, and marketing, selling and administrative expenses. |
(c) |
Certain GAAP reported measures have been adjusted to eliminate a portion of operating expenses, acquired in-process research and development, asset impairment, restructuring and other special charges. During the three months ended |
|
||||||||||||||||||
Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited) |
||||||||||||||||||
(Dollars in millions, except per share data) |
||||||||||||||||||
Nine Months Ended |
Nine Months Ended |
|||||||||||||||||
GAAP |
Adjustments |
Non-GAAP |
GAAP |
Adjustments |
Non-GAAP |
|||||||||||||
Total revenue |
$ |
14,494.3 |
$ |
— |
$ |
14,494.3 |
$ |
17,304.3 |
$ |
— |
$ |
17,304.3 |
||||||
Cost of sales |
3,679.4 |
— |
3,679.4 |
3,521.6 |
— |
3,521.6 |
||||||||||||
Operating expenses(b) (c) |
8,368.8 |
(119.0) |
8,249.7 |
9,227.9 |
— |
9,227.9 |
||||||||||||
|
95.0 |
(95.0) |
— |
— |
— |
— |
||||||||||||
Asset impairment, restructuring and other special charges(c) |
67.7 |
(67.7) |
— |
85.2 |
(85.2) |
— |
||||||||||||
Other income |
203.3 |
— |
203.3 |
509.8 |
(495.4) |
14.4 |
||||||||||||
Income taxes |
524.7 |
53.8 |
578.5 |
1,022.1 |
(158.6) |
863.5 |
||||||||||||
Net income |
$ |
1,962.0 |
228.0 |
$ |
2,190.0 |
$ |
3,957.3 |
(251.6) |
$ |
3,705.7 |
||||||||
Earnings per share - diluted |
$ |
1.82 |
0.21 |
$ |
2.04 |
$ |
3.64 |
(0.23) |
$ |
3.41 |
Numbers do not add due to rounding. | |
(a) |
The company uses non-GAAP financial measures that differ from financial statements reported in conformity with U.S. generally accepted accounting principles (GAAP). The items that are excluded when non-GAAP measures or expectations provided are typically highly variable, difficult to predict, and of a size that could have a substantial impact on the company's reported operations for a period. The company believes that these non-GAAP measures provide useful information to investors. Among other things, they may help investors evaluate the company's ongoing operations. They can assist in making meaningful period-over-period comparisons and in identifying operating trends that would otherwise be masked or distorted by the items subject to the adjustments. Management uses these non-GAAP measures internally to evaluate the performance of the business, including to allocate resources and to evaluate results relative to incentive compensation targets. Investors should consider these non-GAAP measures in addition to, not as a substitute for or superior to, measures of financial performance prepared in accordance with GAAP. |
(b) |
Operating expenses include research and development, and marketing, selling and administrative expenses. |
(c) |
Certain GAAP reported measures have been adjusted to eliminate a portion of operating expenses, acquired in-process research and development, asset impairment, restructuring and other special charges. During the nine months ended |
(d) |
Certain GAAP reported measures have been adjusted to eliminate a portion of other income (expense). During the nine months ended |
Refer to:
(317) 276-5795 -
(317) 277-6524 -
(317) 655-6874 -
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