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8-K - 8-K - Penumbra Incpen-093018x8k.htm


Exhibit 99.1
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Penumbra, Inc. Reports Third Quarter 2018 Financial Results

ALAMEDA, Calif., November 5, 2018 (PR Newswire) - Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today reported financial results for the third quarter ended September 30, 2018.

Revenue of $111.8 million in the third quarter of 2018, an increase of 33.2% over the third quarter of 2017.

Third Quarter 2018 Financial Results
Total revenue grew to $111.8 million for the third quarter of 2018 compared to $83.9 million for the third quarter of 2017, an increase of 33.2%. The United States represented 65% of total revenue and international represented 35% of total revenue for the third quarter of 2018. Revenue from sales of neuro products grew to $74.7 million for the third quarter of 2018, an increase of 27.3%, from the third quarter of 2017. Revenue from sales of peripheral vascular products grew to $37.1 million for the third quarter of 2018, an increase of 47.1%, from the third quarter of 2017.

Gross profit was $75.0 million, or 67.1% of total revenue, for the third quarter of 2018, compared to $54.8 million, or 65.3% of total revenue, for the third quarter of 2017.

In the third quarter of 2018, total operating expenses include a $30.8 million acquired in-process research and development (“IPR&D”) charge in connection with the acquisition of a controlling interest in MVI Health Inc. which was accounted for as an asset acquisition. Total operating expenses for the third quarter of 2018 were $95.9 million, or 85.7% of total revenue. Excluding the IPR&D charge, total adjusted operating expenses1 (a non-GAAP measure) were $65.0 million, or 58.2% of total revenue, for the third quarter of 2018. This compares to total operating expenses of $54.1 million, or 64.5% of total revenue, for the third quarter of 2017. R&D expenses were $9.1 million for the third quarter of 2018, compared to $8.1 million for the third quarter of 2017. SG&A expenses were $55.9 million for the third quarter of 2018, compared to $46.0 million for the third quarter of 2017.

Operating loss for the third quarter of 2018 was $20.8 million. Excluding the IPR&D charge, adjusted operating income1 (a non-GAAP measure) was $10.0 million for the third quarter of 2018. This compares to operating income of $0.7 million for the third quarter of 2017.

Full Year 2018 Financial Outlook
The Company is increasing its 2018 guidance for total revenue to be in the range of $437 million to $438 million. This new range compares to the previous range of $420 million to $425 million.

Webcast and Conference Call Information
Penumbra, Inc. will host a conference call to discuss the third quarter 2018 financial results after market close on Monday, November 5, 2018 at 5:00 PM Eastern Time. The conference call can be accessed live over the phone by dialing (866) 393-4306 for domestic callers or (734) 385-2616 for international callers (conference id: 8597766), or the webcast can be accessed on the “Events” section under the “Investors” tab of the Company’s website at: www.penumbrainc.com. The webcast will be available on the Company’s website for two weeks following the completion of the call.

About Penumbra
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets medical devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs. Penumbra sells its products to hospitals primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc. For more information, visit www.penumbrainc.com.

 
1See “Non-GAAP Financial Measures” below for important information about our use of non-GAAP measures and further information about our adjusted operating expenses and adjusted operating income (loss) measures.

1




Non-GAAP Financial Measures
In addition to financial measures prepared in accordance with U.S. generally accepted accounting principles (“GAAP”), the Company uses the following non-GAAP financial measures in this press release: a) adjusted operating expenses and adjusted operating income (loss), b) adjusted net income (loss) and adjusted diluted earnings per share (“EPS”), and c) constant currency.

Constant Currency. The Company’s constant currency revenue disclosures estimate the impact of changes in foreign currency rates on the translation of the Company’s current period revenue as compared to the applicable comparable period in the prior year. This impact is derived by taking the current local currency revenue and translating it into U.S. dollars based upon the foreign currency exchange rates used to translate the local currency revenue for the applicable comparable period in the prior year, rather than the actual exchange rates in effect during the current period. It does not include any other effect of changes in foreign currency rates on the Company’s results or business. Revenue growth was not reported on a constant currency basis for this period as the percentages were deemed not significant but revenue growth on a constant currency basis is included in the reconciliation below.

Adjusted operating expenses and adjusted operating income (loss). The Company defines adjusted operating expenses as total operating expenses, excluding the IPR&D charge in connection with the MVI Health Inc. asset acquisition. Adjusted operating income (loss) is defined as operating income (loss), excluding the same IPR&D charge.

Adjusted net income (loss) and adjusted diluted EPS. The Company defines adjusted net income (loss) as net income (loss), excluding a) the IPR&D charge in connection with the MVI Health Inc. asset acquisition, b) the one-time effect of the transition tax from the Tax Cuts and Jobs Act of 2017 (the “Tax Reform Act”) in the first quarter of 2018, and c) the effects of the excess tax benefits associated with share-based compensation arrangements, net of any related valuation allowance. The Company defines adjusted diluted EPS as GAAP diluted EPS, excluding the effects of the same items above.

Full reconciliation of these non-GAAP measures to the most comparable GAAP measures is set forth in the tables below.

Our management believes the non-GAAP financial measures disclosed in this press release are useful to investors in assessing the operating performance of our business and provide meaningful comparisons to prior periods and thus a more complete understanding of our business than could be obtained absent this disclosure. Specifically, we consider the change in constant currency revenue as a useful metric as it provides an alternative framework for assessing how our underlying business performed excluding the effect of foreign currency rate fluctuations. We consider adjusted operating expenses, adjusted operating income (loss), adjusted net income (loss), and adjusted diluted EPS useful metrics as they provide an alternative framework for assessing how our underlying business performed. These metrics exclude the effects of the IPR&D charge in connection with the MVI Health Inc. asset acquisition, and, in the case of adjusted net income (loss) and adjusted diluted EPS, the one-time effect of the transition tax from the Tax Reform Act, as well as the effects of excess tax benefits associated with share-based compensation arrangements, net of any related valuation allowance.

The non-GAAP financial measures included in this press release may be different from, and therefore may not be comparable to, similarly titled measures used by other companies. These non-GAAP measures should not be considered in isolation or as alternatives to GAAP measures. We urge investors to review the reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures included in this press release, and not to rely on any single financial measure to evaluate our business.

Forward-Looking Statements
Except for historical information, certain statements in this press release are forward-looking in nature and are subject to risks, uncertainties and assumptions about us. Our business and operations are subject to a variety of risks and uncertainties and, consequently, actual results may differ materially from those projected by any forward-looking statements. Factors that could cause actual results to differ from those projected include, but are not limited to: failure to sustain or grow profitability or generate positive cash flows; failure to effectively introduce and market new products; delays in product introductions; significant competition; inability to further penetrate our current customer base, expand our user base and increase the frequency of use of our products by our customers; inability to achieve or maintain satisfactory pricing and margins; manufacturing difficulties; permanent write-downs or write-offs of our inventory; product defects or failures; unfavorable outcomes in clinical trials; inability to maintain our culture as we grow; fluctuations in foreign currency exchange rates; potential adverse regulatory actions; and potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make. These risks and uncertainties, as well as others, are discussed in greater detail in our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K for the year ended December 31, 2017 filed with the SEC on February 27, 2018. There may be additional risks of which we are not presently aware or that we currently believe are immaterial which could have an adverse impact on our business. Any forward-looking statements are based on our current expectations, estimates and assumptions regarding future events and are applicable only as of the dates of such statements. We make no commitment to revise or update any forward-looking statements in order to reflect events or circumstances that may change.


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Penumbra, Inc.
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands)
 
 
September 30,
2018
 
December 31,
2017
Assets
 
 
 
 
Current assets:
 
 
 
 
     Cash and cash equivalents
 
$
47,742

 
$
50,637

     Marketable investments
 
146,176

 
163,954

Accounts receivable, net
 
80,435

 
58,007

     Inventories
 
109,706

 
94,901

     Prepaid expenses and other current assets
 
13,536

 
14,735

          Total current assets
 
397,595

 
382,234

Property and equipment, net
 
34,133

 
30,899

Intangible assets, net
 
27,284

 
23,778

Goodwill
 
7,923

 
8,178

Long-term investments
 

 
3,872

Deferred taxes
 
32,985

 
26,690

Other non-current assets
 
1,085

 
1,016

         Total assets
 
$
501,005

 
$
476,667

Liabilities and Stockholders’ Equity
 
 
 
 
Current liabilities:
 
 
 
 
     Accounts payable
 
$
8,869

 
$
6,757

     Accrued liabilities
 
56,183

 
44,825

          Total current liabilities
 
65,052

 
51,582

Deferred rent
 
7,510

 
6,199

Other non-current liabilities
 
19,155

 
18,478

          Total liabilities
 
91,717

 
76,259

Stockholders’ equity:
 
 
 
 
Common stock
 
34

 
33

Additional paid-in capital
 
407,881

 
396,810

Accumulated other comprehensive (loss) income
 
(899
)
 
1,569

Retained earnings
 
2,403

 
1,996

Total Penumbra, Inc. stockholders’ equity
 
409,419

 
400,408

Non-controlling interest
 
(131
)
 

Total stockholders’ equity
 
$
409,288

 
$
400,408

Total liabilities and stockholders’ equity
 
$
501,005

 
$
476,667



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Penumbra, Inc.
Condensed Consolidated Statements of Operations
(unaudited)
(in thousands, except share and per share amounts)
 
 
Three Months Ended September 30,
 
Nine Months Ended September 30,
 
 
2018
 
2017
 
2018
 
2017
Revenue
 
$
111,806

 
$
83,911

 
$
324,145

 
$
237,713

Cost of revenue
 
36,794

 
29,134

 
110,324

 
84,298

Gross profit
 
75,012

 
54,777

 
213,821

 
153,415

Operating expenses:
 
 
 
 
 
 
 
 
Research and development
 
9,092

 
8,132

 
25,298

 
23,260

Sales, general and administrative
 
55,934

 
45,962

 
165,209

 
132,846

Acquired in-process research and development
 
30,835

 

 
30,835

 

Total operating expenses
 
95,861

 
54,094

 
221,342

 
156,106

(Loss) income from operations
 
(20,849
)
 
683

 
(7,521
)
 
(2,691
)
Interest income, net
 
771

 
658

 
2,240

 
1,926

Other income (expense), net
 
170

 
(102
)
 
(460
)
 
(665
)
(Loss) income before income taxes and equity in losses of unconsolidated investee
 
(19,908
)
 
1,239

 
(5,741
)
 
(1,430
)
Provision for (benefit from) income taxes
 
1,598

 
456

 
(5,288
)
 
2,293

(Loss) income before equity in losses of unconsolidated investee
 
(21,506
)
 
783

 
(453
)
 
(3,723
)
Equity in losses of unconsolidated investee
 
(920
)
 
(545
)
 
(3,101
)
 
(703
)
Consolidated net (loss) income
 
$
(22,426
)
 
$
238

 
$
(3,554
)
 
$
(4,426
)
Net loss attributable to non-controlling interest
 
(3,496
)
 

 
(3,496
)
 

Net (loss) income attributable to Penumbra, Inc.
 
$
(18,930
)
 
$
238

 
$
(58
)
 
$
(4,426
)
Net (loss) income attributable to Penumbra, Inc. per share:
 
 
 
 
 
 
 
 
Basic
 
$
(0.55
)
 
$
0.01

 
$

 
$
(0.14
)
Diluted
 
$
(0.55
)
 
$
0.01

 
$

 
$
(0.14
)
Weighted average shares outstanding:
 
 
 
 
 
 
 
 
Basic
 
34,248,484

 
33,446,841

 
34,057,216

 
32,766,135

Diluted
 
34,248,484

 
35,664,272

 
34,057,216

 
32,766,135



4



Penumbra, Inc.
Reconciliation of GAAP Operating Expenses and Operating (Loss) Income to Adjusted Operating Expenses and Adjusted Operating Income (Loss)1 
(unaudited)
(in thousands)
 
 
Three Months Ended September 30,
 
Nine Months Ended September 30,
 
 
2018
 
2017
 
2018
 
2017
GAAP operating expenses
 
$
95,861

 
$
54,094

 
$
221,342

 
$
156,106

GAAP total operating expenses and operating (loss) income from operations includes the effect of the following items:
 
 
 
 
 
 
 
 
Acquired IPR&D in connection with an asset acquisition2
 
30,835

 

 
30,835

 

Adjusted operating expenses
 
$
65,026

 
$
54,094

 
$
190,507

 
$
156,106

 
 
 
 
 
 
 
 
 
GAAP operating (loss) income from operations
 
$
(20,849
)
 
$
683

 
$
(7,521
)
 
$
(2,691
)
Adjusted operating income (loss) from operations
 
$
9,986

 
$
683

 
$
23,314

 
$
(2,691
)

Penumbra, Inc.
Reconciliation of GAAP Net Income (Loss) and Diluted EPS to Adjusted Net Income (Loss) and Adjusted Diluted EPS1 
(unaudited)
(in thousands, except share and per share amounts)
 
 
Three Months Ended September 30,
 
Nine Months Ended September 30,
 
 
2018
 
2017
 
2018
 
2017
GAAP net (loss) income attributable to Penumbra, Inc.
 
$
(18,930
)
 
$
238

 
$
(58
)
 
$
(4,426
)
GAAP net (loss) income includes the effect of the following items:
 
 
 
 
 
 
 
 
Acquired IPR&D in connection with an asset acquisition2
 
27,393

 

 
27,393

 

Effect of the transition tax under the Tax Reform Act3
 

 

 
88

 

Excess tax benefits related to stock compensation awards4
 
(2,156
)
 
(2,602
)
 
(13,610
)
 
(19,082
)
Valuation allowance on excess tax benefit related to stock compensation awards4
 

 
2,602

 

 
19,082

Adjusted net income (loss)
 
$
6,307

 
$
238

 
$
13,813

 
$
(4,426
)
 
 
 
 
 
 
 
 
 
GAAP diluted EPS
 
$
(0.55
)
 
$
0.01

 
$

 
$
(0.14
)
Adjusted diluted EPS
 
$
0.17

 
$
0.01

 
$
0.38

 
$
(0.14
)
Weighted average shares outstanding used to compute:
 
 
 
 
 
 
 
 
Adjusted diluted EPS5
 
36,125,198
 
35,664,272
 
36,064,996
 
32,766,135
 
1See “Non-GAAP Financial Measures” above for important information about our use of non-GAAP measures and further information about our adjusted operating expenses, adjusted operating income (loss), adjusted net income (loss) and adjusted diluted EPS measures.
2On August 31, 2018, the Company acquired a controlling interest in MVI Health Inc. which was accounted for as an asset acquisition. In connection with the transaction, the Company recorded a $30.8 million IPR&D charge during the three and nine months ended September 30, 2018, in the consolidated statements of operations related to the acquired technology under development from MVI Health Inc. Of the total IPR&D charge, $27.4 million was attributable to the net loss of Penumbra, Inc. There was no effect on the provision for (benefit from) income taxes related to the IPR&D charge for the three and nine months ended September 30, 2018, respectively.
3On December 22, 2017, the Tax Reform Act was enacted into law. This new tax law, among other changes, reduces the Company’s U.S. federal statutory corporate income tax rate from 34% to 21% effective January 1, 2018. In the first quarter of 2018, the Company recorded a provisional tax charge for the one-time transition tax on the undistributed earnings of its foreign subsidiaries.
4In accordance with Accounting Standards Update No. 2016-09, Improvements to Employee Share-Based Payment Accounting, all excess tax benefits related to share-based compensation be recognized as an income tax benefit, instead of in stockholders’ equity. For the three and nine months ended September 30, 2017, the Company determined that it was not more-likely-than-not that sufficient taxable income would be generated to realize all of the domestic deferred tax assets as of September 30, 2017. Accordingly, the Company recorded a partial valuation allowance against its domestic deferred tax assets generated during the three and nine months ended September 30, 2017, which was primarily driven by the significant excess stock compensation tax benefit.
5GAAP diluted EPS for the three and nine months ended September 30, 2018, is calculated using diluted weighted average shares of approximately 34.2 million and 34.1 million, respectively, which is the same as basic weighted average shares, due to the GAAP net losses incurred in each period.


5



Adjusted diluted EPS for the three and nine months ended September 30, 2018, is calculated using diluted weighted average shares of approximately 36.1 million, for both periods respectively, as the Company had adjusted net income in each period.
Penumbra, Inc.
Reconciliation of Revenue Growth by Geographic Regions to Constant Currency Revenue Growth1 
(unaudited)
(in thousands)
 
 
Three Months Ended September 30,
 
Reported Change
 
 FX Impact
 
Constant Currency Change
 
 
2018
 
2017
 
$
 
%
 
 $
 
$
 
%
United States
 
$
72,991

 
$
55,652

 
$
17,339

 
31.2
%
 
$

 
$
17,339

 
31.2
%
International
 
38,815

 
28,259

 
10,556

 
37.4
%
 
118

 
10,674

 
37.8
%
Total
 
$
111,806

 
$
83,911

 
$
27,895

 
33.2
%
 
$
118

 
$
28,013

 
33.4
%
Penumbra, Inc.
Reconciliation of Revenue Growth by Product Categories to Constant Currency Revenue Growth1 
(unaudited)
(in thousands)
 
 
Three Months Ended September 30,
 
Reported Change
 
 FX Impact
 
Constant Currency Change
 
 
2018
 
2017
 
$
 
%
 
 $
 
$
 
%
Neuro
 
$
74,689

 
$
58,670

 
$
16,019

 
27.3
%
 
$
76

 
$
16,095

 
27.4
%
Peripheral Vascular
 
37,117

 
25,241

 
11,876

 
47.1
%
 
42

 
11,918

 
47.2
%
Total
 
$
111,806

 
$
83,911

 
$
27,895

 
33.2
%
 
$
118

 
$
28,013

 
33.4
%

Penumbra, Inc.
Reconciliation of Revenue Growth by Geographic Regions to Constant Currency Revenue Growth1 
(unaudited)
(in thousands)
 
 
Nine Months Ended September 30,
 
Reported Change
 
 FX Impact
 
Constant Currency Change
 
 
2018
 
2017
 
$
 
%
 
 $
 
$
 
%
United States
 
$
210,070

 
$
157,559

 
$
52,511

 
33.3
%
 
$

 
$
52,511

 
33.3
%
International
 
114,075

 
80,154

 
33,921

 
42.3
%
 
(4,732
)
 
29,189

 
36.4
%
Total
 
$
324,145

 
$
237,713

 
$
86,432

 
36.4
%
 
$
(4,732
)
 
$
81,700

 
34.4
%
Penumbra, Inc.
Reconciliation of Revenue Growth by Product Categories to Constant Currency Revenue Growth1 
(unaudited)
(in thousands)
 
 
Nine Months Ended September 30,
 
Reported Change
 
 FX Impact
 
Constant Currency Change
 
 
2018
 
2017
 
$
 
%
 
 $
 
$
 
%
Neuro
 
$
220,318

 
$
165,122

 
$
55,196

 
33.4
%
 
$
(3,857
)
 
$
51,339

 
31.1
%
Peripheral Vascular
 
103,827

 
72,591

 
31,236

 
43.0
%
 
(875
)
 
30,361

 
41.8
%
Total
 
$
324,145

 
$
237,713

 
$
86,432

 
36.4
%
 
$
(4,732
)
 
$
81,700

 
34.4
%

 
1See “Non-GAAP Financial Measures” above for important information about our use of this non-GAAP measure and further information about our calculation of constant currency results.

Investor Relations
Penumbra, Inc.
510-995-2461
investors@penumbrainc.com 
Source: Penumbra, Inc. 


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