Surmodics Reports Second Quarter Fiscal 2019 Results

Updates Fiscal 2019 Guidance

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 2019 second quarter ended March 31,
2019, and updated its financial outlook for fiscal 2019.

Summary of Second Quarter and Recent Highlights

• Revenue of $22.7 million, an increase of 19% year-over-year
• GAAP EPS of $0.09, non-GAAP EPS of $0.07
• TRANSCEND clinical trial enrollment 75% complete
• FDA Clearance of Sublime™ guide sheath for radial access

“Our second quarter performance marked our fourth consecutive quarter of
double-digit year-over-year revenue growth as both our Medical Device
and IVD businesses continued to generate meaningful top-line gains,”
said Gary Maharaj, President and CEO of Surmodics. “Despite the current
uncertainty related to paclitaxel-coated devices, we have appropriately
adjusted our TRANSCEND trial to respond to the FDA’s recommendations and
are pleased to have many of our trial sites actively enrolling and
randomizing patients. In addition, we continue to make progress on our
key strategic initiatives including the recent FDA 510(k) clearance of
our Sublime guide sheath for radial access to the peripheral
arteries.”

Second Quarter Fiscal 2019 Financial Results

Total revenue for the second quarter of fiscal 2019 was $22.7 million,
as compared with $19.1 million in the prior-year period. Medical Device
revenue was $17.3 million in the second quarter of fiscal 2019, as
compared with $14.1 million in the year-ago period, an increase of 23%,
and includes $1.6 million from our SurVeil™ agreement with Abbott, as
compared with $0.5 million in the prior-year quarter. In Vitro
Diagnostics revenue was $5.4 million for the second quarter of fiscal
2019 as compared with $5.0 million in the same prior-year quarter, an
increase of 7%.

Diluted GAAP earnings per share in the second quarter of fiscal 2019 was
$0.09 as compared with $0.11 in the year-ago period. On a non-GAAP
basis, earnings per share were $0.07 in the second quarter of fiscal
2019, as compared with $0.07 in the year-ago period.

As of March 31, 2019, cash and investments were $46.5 million. Surmodics
generated $1.5 million of cash from operating activities in the second
quarter of fiscal 2019. Capital expenditures totaled $1.0 million for
the second quarter of fiscal 2019.

Fiscal 2019 Guidance Revised

Although we continue to enroll patients in our TRANSCEND trial, the
current uncertainty related to utilization of paclitaxel-coated devices
has and is expected to continue to impact our recognition of SurVeil
revenue and TRANSCEND clinical trial expense. We are updating our
full-year revenue and earnings guidance for fiscal 2019 to account for
this impact, as well as our strong operating performance in the first
half of our fiscal year. We are lowering our fiscal 2019 revenue
expectations by $5.5 million to a range of $88.5 million to $91.5
million, from our previous revenue range of $94 million to $97 million.
We are increasing our fiscal 2019 diluted GAAP EPS to a range of $0.14
to $0.24 per share compared with our previous expectations of a diluted
loss in the range of ($0.22) to a loss of ($0.02) per share. Diluted
non-GAAP EPS is now expected to be in the range of $0.26 to $0.36 per
share compared with previous expectations of $0.02 to $0.22 per share.

Conference Call

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 7350230. The audio replay will be available beginning
at 7 p.m. CT on Wednesday, May 1, 2019, until 7 p.m. CT on Wednesday,
May 8, 2019.

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 whole-product
solutions that are designed to address unmet clinical needs for its
medical device customers 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 SEC.

Safe Harbor for Forward-Looking Statements

This press release contains forward-looking statements. Statements that
are not historical or current facts, including statements about beliefs
and expectations regarding the Company’s performance in the near- and
long-term, including our revenue and earnings expectations for fiscal
2019, our SurVeil DCB and other proprietary products, and the
TRANSCEND clinical trial 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 (1) our ability to successfully develop, timely
complete clinical trials for, obtain regulatory approval for and, if
approved, commercialize our SurVeil DCB (including realization of
the full potential benefits of our agreement with Abbott), 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, and (4) 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, 2018, 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 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 payout 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,
		2019				2018				2019				2018
		(Unaudited)								(Unaudited)
Revenue:
Product sales		$	9,887			$	8,686			$	19,638			$	16,774
Royalties and license fees			9,932				8,428				20,028				15,504
Research, development and other			2,857				1,944				5,251				3,793
Total revenue			22,676				19,058				44,917				36,071
Operating costs and expenses:
Product costs			3,093				2,913				6,616				5,804
Research and development			13,555				10,774				25,041				18,605
Selling, general and administrative			4,876				6,440				10,825				11,628
Acquired intangible asset amortization			604				636				1,210				1,254
Contingent consideration gain			(317	)			(2,230	)			(352	)			(1,112	)
Total operating costs and expenses			21,811				18,533				43,340				36,179
Operating income (loss)			865				525				1,577				(108	)
Other income (loss), net			235				(211	)			657				(99	)
Income (loss) before income taxes			1,100				314				2,234				(207	)
Income tax benefit			162				1,220				338				185
Net income (loss)		$	1,262			$	1,534			$	2,572			$	(22	)
Basic income (loss) per share:		$	0.09			$	0.12			$	0.19			$	(0.00	)
Diluted income (loss) per share:		$	0.09			$	0.11			$	0.19			$	(0.00	)
Weighted average number of shares outstanding:
Basic			13,390				13,102				13,379				13,078
Diluted			13,785				13,465				13,816				13,078

Surmodics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(in thousands)
(Unaudited)
		March 31,			September 30,
		2019			2018
Assets		(Unaudited)
Current Assets:
Cash and cash equivalents		$	22,470		$	23,318
Restricted cash			—			350
Available-for-sale securities			24,023			41,352
Accounts receivable, net			9,312			8,877
Contract assets – royalties and license fees			7,065			—
Inventories, net			4,345			4,016
Prepaids and other			4,302			3,614
Total Current Assets			71,517			81,527
Property and equipment, net			29,512			30,143
Deferred tax assets			5,301			6,304
Intangible assets, net			16,020			17,683
Goodwill			26,549			27,032
Other assets			2,081			1,446
Total Assets		$	150,980		$	164,135
Liabilities and Stockholders’ Equity
Current Liabilities:
Contingent consideration, current portion			3,009			11,041
Deferred revenue			6,385			9,646
Other current liabilities			10,950			14,446
Total Current Liabilities			20,344			35,133
Contingent consideration, less current portion			—			3,425
Deferred revenue, less current portion			10,470			11,247
Other long-term liabilities			4,853			5,720
Total Liabilities			35,667			55,525
Total Stockholders’ Equity			115,313			108,610
Total Liabilities and Stockholders’ Equity		$	150,980		$	164,135

Surmodics, Inc. and Subsidiaries
Supplemental Segment Information
(in thousands)
(Unaudited)
		Three Months Ended March 31,
		2019								2018
Revenue:						% of Total								% of Total				% Change
Medical Device		$	17,301			76.3%				$	14,052			73.7%				23.1%
In Vitro Diagnostics			5,375			23.7%					5,006			26.3%				7.4%
Total revenue		$	22,676							$	19,058							19.0%
		Six Months Ended March 31,
		2019								2018
Revenue:						% of Total								% of Total				% Change
Medical Device		$	34,559			76.9%				$	26,826			74.4%				28.8%
In Vitro Diagnostics			10,358			23.1%					9,245			25.6%				12.0%
Total revenue		$	44,917							$	36,071							24.5%
		Three Months Ended								Six Months Ended
		March 31,								March 31,
		2019				2018				2019				2018
Operating income (loss):
Medical Device		$	(23	)		$	232			$	334			$	(157	)
In Vitro Diagnostics			2,915				2,423				5,370				4,093
Total segment operating income			2,892				2,655				5,704				3,936
Corporate			(2,027	)			(2,130	)			(4,127	)			(4,044	)
Total operating income (loss)		$	865			$	525			$	1,577			$	(108	)

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,
		2019				2018				2019				2018
Net income (loss)		$	1,262			$	1,534			$	2,572			$	(22	)
Income tax benefit			(162	)			(1,220	)			(338	)			(185	)
Depreciation and amortization			1,819				1,586				3,575				3,106
Investment income, net			(265	)			(142	)			(581	)			(263	)
Interest expense			37				—				74				—
EBITDA			2,691				1,758				5,302				2,636
Adjustments:
Contingent consideration gain (1)			(317	)			(2,230	)			(352	)			(1,112	)
Foreign exchange loss (gain) (2)			—				353				(126	)			539
Gain on strategic investment (4)			—				—				(7	)			(177	)
Claim settlement (6)			(650	)			1,000				(650	)			1,000
Adjusted EBITDA		$	1,724			$	881			$	4,167			$	2,886
Net Cash Provided by (Used In) Operating Activities		$	1,467			$	26,817			$	(3,938	)		$	27,431

Estimated Non-GAAP Net Earnings per Common Share Guidance Reconciliation
For the Fiscal Year Ended September 30, 2019
(Unaudited)
		Full Fiscal Year Estimate
		Low				High
GAAP results		$	0.14			$	0.24
Contingent consideration adjustments (1)			0.01				0.01
Foreign exchange gain on contingent consideration (2)			(0.01	)			(0.01	)
Amortization of acquired intangibles (3)			0.16				0.16
Claim settlement (6)			(0.04	)			(0.04	)
Non-GAAP results		$	0.26			$	0.36

Surmodics, Inc., and Subsidiaries
Net Income (Loss) and Diluted EPS GAAP to Non-GAAP Reconciliation
(in thousands, except per share data)
(Unaudited)
		For the Three Months Ended March 31, 2019
												Income
									Operating			Before
		Total			Operating				Income			Income				Net				Diluted				Effective
		Revenue			Income				Percentage			Taxes				Income (7)				EPS				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
Gain on strategic investment (4)			—			—			—				—				—				—
Claim settlement (6)			—			(650	)		(2.9	)			(650	)			(514	)			(0.04	)
Non-GAAP		$	22,676		$	502			2.2	%		$	737			$	990			$	0.07			(34.3	%)

		For the Three Months Ended March 31, 2018
												Income
					Operating				Operating			Before
		Total			Income				Income			Income				Net				Diluted				Effective
		Revenue			(Loss)				Percentage			Taxes				Income (7)				EPS				tax rate
GAAP		$	19,058		$	525			2.8	%		$	314			$	1,534			$	0.11			(388.5	%)
Adjustments:
Contingent consideration gain (1)		―				(2,230	)		(11.7	)			(2,230	)			(2,230	)			(0.17	)
Foreign exchange loss on contingent consideration (2)		―				—			—				338				338				0.03
Amortization of acquired intangible assets (3)		―				636			3.3				636				584				0.04
Claim settlement (6)		―				1,000			5.2				1,000				755				0.06
Non-GAAP		$	19,058		$	(69	)		(0.4	%)		$	58			$	981			$	0.07			(1591.4	%)

Surmodics, Inc., and Subsidiaries
Net Income (Loss) and Diluted EPS GAAP to Non-GAAP Reconciliation – Continued
(in thousands, except per share data)
(Unaudited)
		For the Six Months Ended March 31, 2019
												Income
									Operating			Before
		Total			Operating				Income			Income				Net				Diluted				Effective
		Revenue			Income				Percentage			Taxes				Income (7)				EPS				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	)			(0.00	)
Claim settlement (6)		―				(650	)		(1.4	)			(650	)			(514	)			(0.04	)
Non-GAAP		$	44,917		$	1,785			4.0	%		$	2,309			$	2,694			$	0.19			(16.7	%)

		For the Six Months Ended March 31, 2018
												(Loss)
									Operating			Income
					Operating				(Loss)			Before
		Total			(Loss)				Income			Income				Net (Loss)				Diluted				Effective
		Revenue			Income				Percentage			Taxes				Income (7)				EPS				tax rate
GAAP		$	36,071		$	(108	)		(0.3	%)		$	(207	)		$	(22	)		$	(0.00	)		89.4	%
Adjustments:
Contingent consideration gain (1)		―				(1,112	)		(3.1	)			(1,112	)			(1,112	)			(0.08	)
Foreign exchange loss (2)		―			―				—				518				518				0.04
Amortization of acquired intangible assets (3)		―				1,254			3.5				1,254				1,150				0.09
Gain on strategic investment (4)		―				—			—				(177	)			(177	)			(0.01	)
Tax reform impact (5)		―				—			—				—				1,246				0.09
Claim settlement accrual (6)		―				1,000			2.8				1,000				755				0.06
Non-GAAP		$	36,071		$	1,034			2.9	%		$	1,276			$	2,358			$	0.18			(84.8	%)

(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. The tables include contingent consideration liability adjustments in each respective historical period and do not include in future-period fair value changes, other than estimated accretion expense as determined at the end of the current quarter. 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. The tables include foreign currency exchange loss or gain recorded in each respective historical period and do not include forecasted currency fluctuations in future periods. 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)		Represents the gain recognized on the sale of a strategic investment which was not tax-affected as it was offset by previously recognized capital losses.
(5)		Income tax expense from the re-measurement of net deferred tax assets recognized after the enactment of the Tax Cuts and Jobs Act in December 2017.
(6)		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.
(7)		Net income (loss) includes the effect of the above adjustments on the income tax provision, taking into account deferred taxes and non-deductible items. Effective rates of 21% (fiscal 2019) and 24.5% (fiscal 2018) were used to estimate the income tax impact of the adjustments, except that expenses occurring in Ireland have not been tax-affected as all tax benefits are offset by a full valuation allowance.

Contacts

Surmodics, Inc.
Tim Arens, 952-500-7000
[email protected]