Surmodics Reports Second Quarter Fiscal 2020 Results and Provides COVID-19 Pandemic Update

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EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the healthcare industry, today announced results for its fiscal 2020 second quarter ended March 31, 2020, and suspended its financial guidance for fiscal 2020.

Summary of Second Quarter and Recent Highlights

  • Revenue of $22.8 million, an increase of 1% year-over-year
  • GAAP EPS of $0.11, non-GAAP EPS of $0.04
  • Cash and short-term investments of $48.4 million
  • CE Mark clearance received for Telemark™ coronary/peripheral support microcatheter
  • Partnership announced with Cook Medical for commercialization of .014” and .018” low-profile PTA balloon catheters

“Our customers depend on Surmodics as a critical supplier, with thousands of vital medical device procedures and in vitro diagnostic tests relying on our products every day. The health and safety of our employees is our top priority, and I want to thank our team for their courage and commitment through this COVID-19 health crisis,” said Gary Maharaj, President and CEO of Surmodics, Inc. “While we are operating in an evolving and uncertain environment, our healthy balance sheet, strength of our supply chain, and dedicated team will enable us to continue to effectively operate during these challenging times.”

Response to COVID-19 Pandemic

Since the emergence of COVID-19 in the U.S. and Europe, Surmodics has responded with preparation and action to mitigate the impact of this outbreak on our employees, our community and our mission. In response to directives and recommendations from federal and local government and health agencies, many of the Company’s U.S. and Ireland-based employees have been enabled to work from home. Consistent with applicable government guidance, Surmodics is maintaining its U.S. and Ireland manufacturing operations in order to ensure the uninterrupted supply of our medical device and in vitro diagnostic products and technologies, which are essential for our customers to provide often life-saving care to patients. With workplace health and safety a top priority, Surmodics has implemented recommended best practices to protect our employees. While great uncertainty remains about the duration and impacts of the COVID-19 pandemic, Surmodics management remains confident in the long-term underlying strength of the Company’s customer base, innovation pipeline, business model and balance sheet.

Second Quarter Fiscal 2020 Financial Results

Total revenue for the second quarter of fiscal 2020 was $22.8 million, as compared with $22.7 million in the prior-year period. Medical Device revenue was $16.3 million in the second quarter of fiscal 2020, as compared with $17.3 million in the year-ago period, a decrease of 6%. Medical Device revenue was significantly impacted both by the expiration of the Company’s fourth generation hydrophilic coating patents and by postponement of non-essential procedures as a result of the COVID-19 pandemic. In Vitro Diagnostics revenue was $6.5 million for the second quarter of fiscal 2020, as compared with $5.4 million in the same prior-year quarter, an increase of 21%.

Diluted GAAP earnings per share in the second quarter of fiscal 2020 was $0.11, as compared with $0.09 in the year-ago period. On a non-GAAP basis, earnings per share was $0.04 in the second quarter of fiscal 2020, as compared with $0.07 in the year-ago period.

As of March 31, 2020, cash and short-term investments totaled $48.4 million. Surmodics generated $2.2 million of cash from operating activities in the second quarter of fiscal 2020. Capital expenditures totaled $0.6 million for the second quarter of fiscal 2020. In response to COVID-19, Surmodics has taken prudent measures including targeted delays in capital expenditures and hiring and reductions in discretionary operating expenses, without sacrificing investments in our key strategic initiatives.

Fiscal 2020 Guidance

Due to the uncertainty surrounding the duration and magnitude of the COVID-19 pandemic, Surmodics is suspending the previously issued financial guidance for fiscal year 2020.

Conference Call Today at 4 p.m. CT (5 p.m. ET)

Surmodics will host a webcast at 4 p.m. CT (5 p.m. ET) today to discuss second quarter results. To access the webcast, go to the investor relations portion of the Company’s website at https://surmodics.gcs-web.com and click on the webcast icon. The webcast will be archived on the Company’s website for 90 days. A replay of the second quarter conference call will be available by dialing 888-203-1112 and entering conference call ID passcode 2200822. The audio replay will be available beginning at 7 p.m. CT on Wednesday, April 29, 2020, until 7 p.m. CT on Wednesday, May 6, 2020.

About Surmodics, Inc.

Surmodics is the global leader in surface modification technologies for intravascular medical devices and a leading provider of chemical components for in vitro diagnostic (IVD) immunoassay tests and microarrays. Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease. Surmodics is headquartered in Eden Prairie, Minnesota. For more information, visit www.surmodics.com. The content of Surmodics’ website is not part of this press release or part of any filings that the company makes with the Securities and Exchange Commission(“SEC”).

Safe Harbor for Forward-looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements that are not historical or current facts, including statements about beliefs and expectations regarding the Company’s ability to continue to operate effectively during COVID-19 challenges, expectations about the impact of delayed elective procedures on our medical device business, expectations about clinical trial data, and statements about initiating future clinical trials, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and important factors could cause actual results to differ materially from those anticipated, including, without limitation: (1) our ability to successfully develop and commercialize our SurVeilTM DCB (including realization of the full potential benefits of our agreement with Abbott), AvessTM DCB, SundanceTM DCB and other proprietary products; (2) our reliance on third parties (including our customers and licensees) and their failure to successfully develop, obtain regulatory approval for, market and sell products incorporating our technologies; (3) possible adverse market conditions and possible adverse impacts on our cash flows; (4) the impacts, duration and severity of the global COVID-19 pandemic and the effects of responses to it on healthcare systems, the general economy, our business partners, and our operations; and (5) the factors identified under “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended September 30, 2019, and updated in our subsequent reports filed with the SEC. These reports are available in the Investors section of our website at https://surmodics.gcs-web.com and at the SEC website at www.sec.gov. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update them in light of new information or future events.

Use of Non-GAAP Financial Information

In addition to reporting financial results in accordance with U.S. generally accepted accounting principles, or GAAP, Surmodics is reporting non-GAAP financial results including EBITDA and Adjusted EBITDA, non-GAAP operating income, non-GAAP operating income percentage, non-GAAP income before income taxes, non-GAAP net income, and non-GAAP diluted earnings per share, and the non-GAAP effective income tax rate. We believe that these non-GAAP measures, when read in conjunction with the Company’s GAAP financial statements, provide meaningful insight into our operating performance excluding certain event-specific matters, and provide an alternative perspective of our results of operations. We use non-GAAP measures, including those set forth in this release, to assess our operating performance and to determine payouts under our executive compensation programs. We believe that presentation of certain non-GAAP measures allows investors to review our results of operations from the same perspective as management and our board of directors and facilitates comparisons of our current results of operations. The method we use to produce non-GAAP results is not in accordance with GAAP and may differ from the methods used by other companies. Non-GAAP results should not be regarded as a substitute for corresponding GAAP measures but instead should be utilized as a supplemental measure of operating performance in evaluating our business. Non-GAAP measures do have limitations in that they do not reflect certain items that may have a material impact on our reported financial results. As such, these non-GAAP measures should be viewed in conjunction with both our financial statements prepared in accordance with GAAP and the reconciliation of the supplemental non-GAAP financial measures to the comparable GAAP results provided for the specific periods presented, which are attached to this release.

Surmodics, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations

(in thousands, except per share data)

(Unaudited)

Three Months Ended

Six Months Ended

March 31,

March 31,

2020

2019

2020

2019

Revenue:

Product sales

$

11,770

$

9,887

$

21,744

$

19,638

Royalties and license fees

8,221

9,932

18,369

20,028

Research, development and other

2,831

2,857

5,325

5,251

Total revenue

22,822

22,676

45,438

44,917

Operating costs and expenses:

Product costs

3,769

3,093

6,972

6,616

Research and development

11,935

13,555

24,077

25,041

Selling, general and administrative

6,733

4,876

13,676

10,825

Acquired intangible asset amortization

541

604

1,135

1,210

Contingent consideration gain

(317

)

(352

)

Total operating costs and expenses

22,978

21,811

45,860

43,340

Operating (loss) income

(156

)

865

(422

)

1,577

Other (expense) income

(329

)

235

(165

)

657

(Loss) income before income taxes

(485

)

1,100

(587

)

2,234

Income tax benefit

1,947

162

2,197

338

Net income

$

1,462

$

1,262

$

1,610

$

2,572

Basic net income per share

$

0.11

$

0.09

$

0.12

$

0.19

Diluted net income per share

$

0.11

$

0.09

$

0.12

$

0.19

Weighted average number of shares outstanding:

Basic

13,507

13,390

13,474

13,379

Diluted

13,751

13,785

13,779

13,816

Surmodics, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

(in thousands)

March 31,

September 30,

2020

2019

Assets

(Unaudited)

(See note)

Current Assets:

Cash and cash equivalents

$

15,208

$

30,361

Available-for-sale securities

33,190

24,931

Accounts receivable, net

8,886

8,993

Contract assets – royalties and license fees

6,282

8,210

Inventories, net

5,740

4,501

Prepaids and other

7,995

4,424

Total Current Assets

77,301

81,420

Property and equipment, net

29,785

29,748

Deferred tax assets

4,788

6,176

Intangible assets, net

13,037

14,226

Goodwill

26,276

26,171

Other assets

4,360

2,124

Total Assets

$

155,547

$

159,865

Liabilities and Stockholders’ Equity

Current Liabilities:

Contingent consideration, current portion

3,200

Deferred revenue

4,675

5,553

Other current liabilities

8,603

11,456

Total Current Liabilities

13,278

20,209

Deferred revenue

9,861

11,628

Other long-term liabilities

7,442

5,512

Total Liabilities

30,581

37,349

Total Stockholders’ Equity

124,966

122,516

Total Liabilities and Stockholders’ Equity

$

155,547

$

159,865

Note: Derived from audited financial statements as of the date indicated.

Surmodics, Inc. and Subsidiaries

Supplemental Segment Information

(in thousands)

(Unaudited)

Three Months Ended March 31,

2020

2019

Revenue:

% of Total

% of Total

% Change

Medical Device

$

16,304

71.4%

$

17,301

76.3%

(5.8)%

In Vitro Diagnostics

6,518

28.6%

5,375

23.7%

21.3%

Total revenue

$

22,822

$

22,676

0.6%

Six Months Ended March 31,

2020

2019

Revenue:

% of Total

% of Total

% Change

Medical Device

$

33,708

74.2%

$

34,559

76.9%

(2.5)%

In Vitro Diagnostics

11,730

25.8%

10,358

23.1%

13.2%

Total revenue

$

45,438

$

44,917

1.2%

Three Months Ended

Six Months Ended

March 31,

March 31,

2020

2019

2020

2019

Operating (loss) income:

Medical Device

$

(1,453

)

$

(23

)

$

(1,876

)

$

334

In Vitro Diagnostics

3,462

2,915

6,061

5,370

Total segment operating income

2,009

2,892

4,185

5,704

Corporate

(2,165

)

(2,027

)

(4,607

)

(4,127

)

Total operating (loss) income

$

(156

)

$

865

$

(422

)

$

1,577

Surmodics, Inc. and Subsidiaries

Reconciliation of GAAP Measures to Non-GAAP Amounts

Schedule of EBITDA, Adjusted EBITDA and Cash Flows from Operations

(in thousands)

(Unaudited)

Three Months Ended

Six Months Ended

March 31,

March 31,

2020

2019

2020

2019

EBITDA and Adjusted EBITDA

Net income

$

1,462

$

1,262

$

1,610

$

2,572

Income tax benefit

(1,947

)

(162

)

(2,197

)

(338

)

Depreciation and amortization

1,796

1,819

3,600

3,575

Investment income, net

(210

)

(265

)

(460

)

(581

)

Interest expense

30

37

70

74

EBITDA

1,131

2,691

2,623

5,302

Adjustments:

Contingent consideration gain (1)

(317

)

(352

)

Foreign exchange gain (2)

(126

)

Loss (gain) on strategic investments (4)

479

479

(7

)

Claim settlement (7)

(650

)

(650

)

Adjusted EBITDA

$

1,610

$

1,724

$

3,102

$

4,167

Cash Flows from Operations

Net cash provided by (used in) operating activities

$

2,166

$

1,467

$

1,257

$

(3,938

)

Surmodics, Inc., and Subsidiaries

Net Income and Diluted EPS GAAP to Non-GAAP Reconciliation

(in thousands, except per share data)

(Unaudited)

For the Three Months Ended March 31, 2020

Total
Revenue

Operating
(Loss)
Income

Operating
(Loss)
Income
Percentage

(Loss)
Income
Before
Income
Taxes

Net
Income
(6)

Diluted
EPS

Effective
tax rate

GAAP

$22,822

$(156)

(0.7)%

$(485)

$1,462

$0.11

401.4 %

Adjustments:

Amortization of acquired intangible assets (3)

541

2.4 %

541

507

0.03

Loss on strategic investment (4)

479

378

0.03

Tax impact of CARES Act (5)

(1,768)

(0.13)

Non-GAAP

$22,822

$385

1.7 %

$535

$579

$0.04

(8.2)%

For the Three Months Ended March 31, 2019

Total
Revenue

Operating
Income

Operating
Income
Percentage

Income
Before
Income
Taxes

Net
Income
(6)

Diluted
EPS

Effective
tax rate

GAAP

$22,676

$865

3.8 %

$1,100

$1,262

$0.09

(14.7)%

Adjustments:

Contingent consideration gain (1)

(317)

(1.4)%

(317)

(317)

(0.02)

Amortization of acquired intangible assets (3)

604

2.7 %

604

559

0.04

Claim settlement (7)

(650)

(2.9)%

(650)

(514)

(0.04)

Non-GAAP

$22,676

$502

2.2 %

$737

$990

$0.07

(34.3)%

Surmodics, Inc., and Subsidiaries

Net Income and Diluted EPS GAAP to Non-GAAP Reconciliation – Continued

(in thousands, except per share data)

(Unaudited)

For the Six Months Ended March 31, 2020

Total
Revenue

Operating
(Loss)
Income

Operating
(Loss)
Income
Percentage

(Loss)
Income
Before
Income
Taxes

Net
Income
(6)

Diluted
EPS

Effective
tax rate

GAAP

$

45,438

$

(422

)

(0.9

)%

$

(587

)

$

1,610

$

0.12

374.3

%

Adjustments:

Amortization of acquired intangible assets (3)

1,135

2.5

%

1,135

1,056

0.07

Loss on strategic investment (4)

479

378

0.03

Tax impact of CARES Act (5)

(1,768

)

(0.13

)

Non-GAAP

$

45,438

$

713

1.6

%

$

1,027

$

1,276

$

0.09

(24.2

)%

For the Six Months Ended March 31, 2019

Total
Revenue

Operating
Income

Operating
Income
Percentage

Income
Before
Income
Taxes

Net
Income
(6)

Diluted
EPS

Effective
tax rate

GAAP

$

44,917

$

1,577

3.5

%

$

2,234

$

2,572

$

0.19

(15.1

)%

Adjustments:

Contingent consideration gain (1)

(352

)

(0.8

)%

(352

)

(352

)

(0.03

)

Foreign exchange gain (2)

(126

)

(126

)

(0.01

)

Amortization of acquired intangible assets (3)

1,210

2.7

%

1,210

1,121

0.08

Gain on strategic investment (4)

(7

)

(7

)

Claim settlement (7)

(650

)

(1.4

)%

(650

)

(514

)

(0.04

)

Non-GAAP

$

44,917

$

1,785

4.0

%

$

2,309

$

2,694

$

0.19

(16.7

)%

(1)

Represents accounting adjustments to state acquisition-related contingent consideration liabilities at their estimated fair value, including accretion for the passage of time as well as adjustments to the liabilities’ fair values related to changes in the timing and/or probability of achieving milestones. These amounts are not taxable or tax deductible.

(2)

Foreign exchange gains and losses are related to marking non-U.S. dollar contingent consideration to period-end or settlement date exchange rates. These gains and losses are not taxable or tax deductible.

(3)

Amortization of acquisition-related intangible assets and associated tax impact. A significant portion of the acquisition-related amortization is not tax deductible.

(4)

In fiscal 2020, represents the loss recognized on the impairment of a strategic investment for which an effective rate of 21% was used to estimate the income tax impact. In fiscal 2019, represents the gain recognized on the sale of a strategic investment which was not tax-effected as it was offset by previously recognized capital losses.

(5)

Represents the income tax benefit recognized from the carryback of net operating losses under the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) enacted in March 2020.

(6)

Net income includes the effect of the above adjustments on the income tax benefit, taking into account deferred taxes and non-deductible items. In both fiscal 2020 and fiscal 2019, an effective rate of 21% was used to estimate the income tax impact of the adjustments, except that expenses occurring in Ireland have not been tax-effected as all tax benefits are offset by a full valuation allowance.

(7)

Represents a royalty-related customer claim accrued at $1.0 million in the second quarter of fiscal 2018, settled in the second quarter of 2019 for $0.4 million.

 

Contacts

Surmodics, Inc.
Tim Arens, 952-500-7000
ir@surmodics.com

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