Surmodics Reports First Quarter of Fiscal Year 2024 Financial Results; Updates Fiscal Year 2024 Financial Guidance
First Quarter Fiscal 2024 Financial Summary
- Total Revenue of
$30.6 million , an increase of 23% year-over-year - Total Revenue excluding SurVeil™ drug-coated balloon (“DCB”) license fee revenue(1) of
$29.6 million , an increase of 25% year-over-year - GAAP net loss of
$(0.8) million , compared to$(7.8) million in the prior-year period - Adjusted EBITDA(2) of
$3.9 million , compared to$(3.3) million in the prior-year period
First Quarter and Recent Business Highlights
- On
October 31, 2023 ,Surmodics announced the launch of its Preside™ medical device coating technology providing industry-leading lubricity and durability to a broader range of complex device applications. - On
November 16, 2023 ,Surmodics announced that 36-month data from its TRANSCEND clinical trial of the company’s SurVeil DCB was presented at the Symposium on Vascular and Endovascular Issues (“VEITHsymposium”) inNew York, NY , with the SurVeil DCB demonstrating sustained durability of the trial’s safety and efficacy endpoints. - On
November 16, 2023 ,Surmodics announced that 24-month data from its SWING trial, a first-in-human study of the company’s Sundance™ Sirolimus DCB, was presented at the VEITHsymposium, with a per protocol analysis demonstrating that primary patency was maintained in the target lesion in 71% of patients at 24-months, with an excellent safety profile. - On
January 22, 2024 ,Surmodics announced the successful early clinical use of the Pounce™ LP (Low Profile) Thrombectomy System, designed to address a critical, unmet need by facilitating removal of thrombi and emboli below the knee.
“We delivered total revenue growth in the first quarter that exceeded our expectations, increasing 23% year-over-year – 25% excluding SurVeil DCB license fees(1) – with impressive performance in both our Medical Device and
First Quarter Fiscal 2024 Financial Results
|
Three Months Ended |
|
|
Increase |
|
||||||||||
|
2023 |
|
|
2022 |
|
|
$ |
|
|
% |
|
||||
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
||||
Medical Device |
$ |
23,545 |
|
|
$ |
19,018 |
|
|
$ |
4,527 |
|
|
|
24 |
% |
In |
|
7,007 |
|
|
|
5,915 |
|
|
|
1,092 |
|
|
|
18 |
% |
Total revenue |
$ |
30,552 |
|
|
$ |
24,933 |
|
|
$ |
5,619 |
|
|
|
23 |
% |
Total revenue increased
Medical Device revenue increased
Product gross profit(3) increased
Operating costs and expenses, excluding product costs, decreased
GAAP net loss was
Adjusted EBITDA(2) was
Balance Sheet Summary
As of
Fiscal Year 2024 Financial Guidance
The company now expects fiscal 2024 GAAP diluted loss per share to range from
Non-GAAP diluted loss per share(4) in fiscal 2024 is now expected to range from
Conference Call Today at
An audio replay of the conference call will be available beginning at
About
Safe Harbor for Forward-looking Statements
This press release, and disclosures related to it, contain 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 regarding: future success; our ability to execute our stated strategic objectives while continuing to focus on cash efficiency; our access to additional borrowings under our existing credit agreement; the potential of the SurVeil DCB products, Pounce thrombectomy products, and Sublime radial access products to be growth catalysts; the SurVeil DCB being positioned as the next generation of drug-coated balloons; our commitment to addressing Abbott’s future demand for SurVeil DCB products; our belief that two digital supplements in Endovascular Today will serve as an important resource for potential customers that our sales team can continue to leverage going forward; laying the foundation for our future, long-term growth by advancing our pipeline of new products and line extensions; supporting customers’ efforts as they integrate our Preside coating technology into their next-generation devices and pursue regulatory clearance; our expectations related to completing the limited market evaluation cases for our Pounce venous thrombectomy system and its limited and full commercial launches; that our Pounce
Use of Non-GAAP Financial Information
In addition to reporting financial results in accordance with
|
|||||||
Condensed Consolidated Statements of Operations |
|||||||
(in thousands, except per share data) |
|||||||
(Unaudited) |
|||||||
|
Three Months Ended |
||||||
|
2023 |
|
2022 |
||||
Revenue: |
|
|
|
||||
Product sales |
$ |
18,827 |
|
|
$ |
14,234 |
|
Royalties and license fees |
|
9,179 |
|
|
|
8,765 |
|
Research, development and other |
|
2,546 |
|
|
|
1,934 |
|
Total revenue |
|
30,552 |
|
|
|
24,933 |
|
Operating costs and expenses: |
|
|
|
||||
Product costs |
|
8,803 |
|
|
|
5,267 |
|
Research and development |
|
8,664 |
|
|
|
12,743 |
|
Selling, general and administrative |
|
12,537 |
|
|
|
13,239 |
|
Acquired intangible asset amortization |
|
870 |
|
|
|
913 |
|
Total operating costs and expenses |
|
30,874 |
|
|
|
32,162 |
|
Operating loss |
|
(322 |
) |
|
|
(7,229 |
) |
Other expense, net |
|
(402 |
) |
|
|
(779 |
) |
Loss before income taxes |
|
(724 |
) |
|
|
(8,008 |
) |
Income tax (expense) benefit |
|
(62 |
) |
|
|
165 |
|
Net loss |
$ |
(786 |
) |
|
$ |
(7,843 |
) |
|
|
|
|
||||
Basic net loss per share |
$ |
(0.06 |
) |
|
$ |
(0.56 |
) |
Diluted net loss per share |
$ |
(0.06 |
) |
|
$ |
(0.56 |
) |
|
|
|
|
||||
Weighted average number of shares outstanding: |
|
|
|
||||
Basic |
|
14,102 |
|
|
|
13,983 |
|
Diluted |
|
14,102 |
|
|
|
13,983 |
|
|
|||||||
Condensed Consolidated Balance Sheets |
|||||||
(in thousands) |
|||||||
|
|
|
|
||||
|
2023 |
|
2023 |
||||
Assets |
(Unaudited) |
|
(See Note) |
||||
Current Assets: |
|
|
|
|
|
||
Cash and cash equivalents |
$ |
23,355 |
|
|
$ |
41,419 |
|
Available-for-sale securities |
|
11,819 |
|
|
|
3,933 |
|
Accounts receivable, net |
|
12,919 |
|
|
|
10,850 |
|
Contract assets |
|
9,178 |
|
|
|
7,796 |
|
Inventories, net |
|
14,438 |
|
|
|
14,839 |
|
Prepaids and other |
|
8,099 |
|
|
|
7,854 |
|
Total Current Assets |
|
79,808 |
|
|
|
86,691 |
|
Property and equipment, net |
|
25,563 |
|
|
|
26,026 |
|
Intangible assets, net |
|
26,213 |
|
|
|
26,206 |
|
|
|
44,283 |
|
|
|
42,946 |
|
Other assets |
|
4,373 |
|
|
|
3,864 |
|
Total Assets |
$ |
180,240 |
|
|
$ |
185,733 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
||
Current Liabilities: |
|
|
|
|
|
||
Deferred revenue |
|
4,008 |
|
|
|
4,378 |
|
Other current liabilities |
|
12,469 |
|
|
|
19,576 |
|
Total Current Liabilities |
|
16,477 |
|
|
|
23,954 |
|
Long-term debt, net |
|
29,443 |
|
|
|
29,405 |
|
Deferred revenue |
|
1,648 |
|
|
|
2,400 |
|
Other long-term liabilities |
|
10,522 |
|
|
|
10,064 |
|
Total Liabilities |
|
58,090 |
|
|
|
65,823 |
|
Total Stockholders’ Equity |
|
122,150 |
|
|
|
119,910 |
|
Total Liabilities and Stockholders’ Equity |
$ |
180,240 |
|
|
$ |
185,733 |
|
|
|
|
|
|
|
||
Note: Derived from audited financial statements as of the date indicated. |
|
|
|||||||
Condensed Consolidated Statements of Cash Flows |
|||||||
(in thousands) |
|||||||
(Unaudited) |
|||||||
|
Three Months Ended |
||||||
|
2023 |
|
2022 |
||||
Operating Activities: |
|
|
|
||||
Net loss |
$ |
(786 |
) |
|
$ |
(7,843 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
||||
Depreciation and amortization |
|
2,333 |
|
|
|
2,122 |
|
Stock-based compensation |
|
1,968 |
|
|
|
1,965 |
|
Deferred taxes |
|
(97 |
) |
|
|
(107 |
) |
Other |
|
142 |
|
|
|
374 |
|
Change in operating assets and liabilities: |
|
|
|
||||
Accounts receivable and contract assets |
|
(3,430 |
) |
|
|
546 |
|
Inventories |
|
401 |
|
|
|
(905 |
) |
Prepaids and other |
|
(788 |
) |
|
|
(1,857 |
) |
Accounts payable |
|
(428 |
) |
|
|
(1,254 |
) |
Accrued liabilities |
|
(7,084 |
) |
|
|
(4,700 |
) |
Income taxes |
|
99 |
|
|
|
2,218 |
|
Deferred revenue |
|
(1,122 |
) |
|
|
(1,361 |
) |
Net cash used in operating activities |
|
(8,792 |
) |
|
|
(10,802 |
) |
Investing Activities: |
|
|
|
||||
Purchases of property and equipment |
|
(720 |
) |
|
|
(977 |
) |
Purchases of available-for-sale securities |
|
(9,750 |
) |
|
|
— |
|
Maturities of available-for-sale securities |
|
2,000 |
|
|
|
— |
|
Net cash used in investing activities |
|
(8,470 |
) |
|
|
(977 |
) |
Financing Activities: |
|
|
|
||||
Payments of short-term borrowings |
|
— |
|
|
|
(10,000 |
) |
Proceeds from issuance of long-term debt |
|
— |
|
|
|
29,664 |
|
Payments of debt issuance costs |
|
— |
|
|
|
(353 |
) |
Issuance of common stock |
|
39 |
|
|
|
347 |
|
Payments for taxes related to net share settlement of equity awards |
|
(1,088 |
) |
|
|
(858 |
) |
Net cash (used in) provided by financing activities |
|
(1,049 |
) |
|
|
18,800 |
|
Effect of exchange rate changes on cash |
|
247 |
|
|
|
411 |
|
Net change in cash and cash equivalents |
|
(18,064 |
) |
|
|
7,432 |
|
Cash and Cash Equivalents: |
|
|
|
||||
Beginning of period |
|
41,419 |
|
|
|
18,998 |
|
End of period |
$ |
23,355 |
|
|
$ |
26,430 |
|
|
|||||||||||||||
Supplemental Revenue Information |
|||||||||||||||
(in thousands) |
|||||||||||||||
(Unaudited) |
|||||||||||||||
|
Three Months Ended |
|
Increase (Decrease) |
||||||||||||
|
2023 |
|
2022 |
|
$ |
|
% |
||||||||
Medical Device Revenue |
|
|
|
|
|
|
|
|
|
|
|
||||
Product sales |
$ |
11,950 |
|
|
$ |
8,380 |
|
|
$ |
3,570 |
|
|
|
43 |
% |
Royalties & license fees – performance coatings |
|
8,208 |
|
|
|
7,469 |
|
|
|
739 |
|
|
|
10 |
% |
License fees – SurVeil DCB(1) |
|
971 |
|
|
|
1,296 |
|
|
|
(325 |
) |
|
|
(25 |
)% |
R&D and other |
|
2,416 |
|
|
|
1,873 |
|
|
|
543 |
|
|
|
29 |
% |
Medical Device revenue |
|
23,545 |
|
|
|
19,018 |
|
|
|
4,527 |
|
|
|
24 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
||||
In Vitro Diagnostics Revenue |
|
|
|
|
|
|
|
|
|
|
|
||||
Product sales |
|
6,877 |
|
|
|
5,854 |
|
|
|
1,023 |
|
|
|
17 |
% |
R&D and other |
|
130 |
|
|
|
61 |
|
|
|
69 |
|
|
|
113 |
% |
In |
|
7,007 |
|
|
|
5,915 |
|
|
|
1,092 |
|
|
|
18 |
% |
Total Revenue |
$ |
30,552 |
|
|
$ |
24,933 |
|
|
$ |
5,619 |
|
|
|
23 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Medical Device Revenue, excluding |
$ |
22,574 |
|
|
$ |
17,722 |
|
|
$ |
4,852 |
|
|
|
27 |
% |
Total Revenue, excluding |
$ |
29,581 |
|
|
$ |
23,637 |
|
|
$ |
5,944 |
|
|
|
25 |
% |
|
|||||||||||
Supplemental Segment Information |
|||||||||||
(in thousands) |
|||||||||||
(Unaudited) |
|||||||||||
|
Three Months Ended |
|
Increase (Decrease) |
||||||||
|
2023 |
|
2022 |
|
$ |
||||||
Operating Loss: |
|
|
|
|
|
||||||
Medical Device |
$ |
(224 |
) |
|
$ |
(7,235 |
) |
|
$ |
7,011 |
|
In |
|
3,124 |
|
|
|
2,948 |
|
|
|
176 |
|
Total segment operating income (loss) |
|
2,900 |
|
|
|
(4,287 |
) |
|
|
7,187 |
|
Corporate |
|
(3,222 |
) |
|
|
(2,942 |
) |
|
|
(280 |
) |
Total Operating Loss |
$ |
(322 |
) |
|
$ |
(7,229 |
) |
|
$ |
6,907 |
|
|
|||||||||||
GAAP to Non-GAAP Reconciliation: EBITDA and Adjusted EBITDA |
|||||||||||
(in thousands) |
|||||||||||
(Unaudited) |
|||||||||||
|
Three Months Ended |
|
Increase (Decrease) |
||||||||
|
2023 |
|
2022 |
|
$ |
||||||
Net loss |
$ |
(786 |
) |
|
$ |
(7,843 |
) |
|
$ |
7,057 |
|
Income tax expense (benefit) |
|
62 |
|
|
|
(165 |
) |
|
|
227 |
|
Depreciation and amortization |
|
2,333 |
|
|
|
2,122 |
|
|
|
211 |
|
Interest expense, net |
|
896 |
|
|
|
826 |
|
|
|
70 |
|
Investment income, net |
|
(539 |
) |
|
|
(172 |
) |
|
|
(367 |
) |
EBITDA |
|
1,966 |
|
|
|
(5,232 |
) |
|
|
7,198 |
|
|
|
|
|
|
|
||||||
Adjustments: |
|
|
|
|
|
||||||
Stock-based compensation expense |
|
1,968 |
|
|
|
1,965 |
|
|
|
3 |
|
Adjusted EBITDA |
$ |
3,934 |
|
|
$ |
(3,267 |
) |
|
$ |
7,201 |
|
|
|||||||||||||||||||
GAAP to Non-GAAP Reconciliation: Net (Loss) Income and Diluted EPS |
|||||||||||||||||||
(in thousands, except per share data) |
|||||||||||||||||||
(Unaudited) |
|||||||||||||||||||
|
Three Months Ended |
||||||||||||||||||
|
Operating (Loss) Income |
|
Loss (Income) |
|
Net (Loss) |
|
Diluted EPS |
||||||||||||
GAAP |
$ |
(322 |
) |
|
|
(1.1 |
)% |
|
$ |
(724 |
) |
|
$ |
(786 |
) |
|
$ |
(0.06 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
||||||||||
Amortization of acquired intangible assets(5) |
|
870 |
|
|
|
2.9 |
% |
|
|
870 |
|
|
|
805 |
|
|
|
0.06 |
|
Non-GAAP |
$ |
548 |
|
|
|
1.8 |
% |
|
$ |
146 |
|
|
$ |
19 |
|
|
$ |
0.00 |
|
Diluted weighted average shares |
|
|
|
|
|
|
|
|
|
14,167 |
|
|
Three Months Ended |
||||||||||||||||||
|
Operating Loss |
|
Loss Before |
|
Net Loss(6) |
|
Diluted EPS |
||||||||||||
GAAP |
$ |
(7,229 |
) |
|
|
(29.0 |
)% |
|
$ |
(8,008 |
) |
|
$ |
(7,843 |
) |
|
$ |
(0.56 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
||||||||||
Amortization of acquired intangible assets(5) |
|
913 |
|
|
|
3.7 |
% |
|
|
913 |
|
|
|
851 |
|
|
|
0.06 |
|
Non-GAAP |
$ |
(6,316 |
) |
|
|
(25.3 |
)% |
|
$ |
(7,095 |
) |
|
$ |
(6,992 |
) |
|
$ |
(0.50 |
) |
Diluted weighted average shares |
|
|
|
|
|
|
|
|
|
13,983 |
|
|
|||||||||||||||||||
Guidance Reconciliation: Revenue |
|||||||||||||||||||
For the Fiscal Year Ending |
|||||||||||||||||||
(in millions) |
|||||||||||||||||||
(Unaudited) |
|||||||||||||||||||
|
Fiscal 2024 Full-Year Estimate |
|
Increase (Decrease) |
|
|
||||||||||||||
|
Low |
|
High |
|
Low |
|
High |
|
Fiscal 2023 |
||||||||||
Total Revenue |
$ |
117 |
|
|
$ |
121 |
|
|
|
(12 |
)% |
|
|
(9 |
)% |
|
$ |
133 |
|
License fees – SurVeil DCB(1) |
|
(4 |
) |
|
|
(4 |
) |
|
|
(86 |
)% |
|
|
(86 |
)% |
|
|
(30 |
) |
Total Revenue, excluding SurVeil DCB license fees(1) |
$ |
113 |
|
|
$ |
117 |
|
|
|
10 |
% |
|
|
14 |
% |
|
$ |
103 |
|
|
|||||||
Guidance Reconciliation: Non-GAAP Diluted EPS |
|||||||
For the Fiscal Year Ending |
|||||||
(shares in thousands) |
|||||||
(Unaudited) |
|||||||
|
Fiscal 2024 Full-Year Estimate |
||||||
|
Low |
|
High |
||||
GAAP Diluted EPS |
$ |
(1.40 |
) |
|
$ |
(1.10 |
) |
Amortization of acquired intangibles per diluted share(5) |
|
0.23 |
|
|
|
0.23 |
|
Non-GAAP Diluted EPS |
$ |
(1.17 |
) |
|
$ |
(0.87 |
) |
Diluted weighted average shares outstanding |
|
14,150 |
|
|
|
(1) |
SurVeil DCB license fee revenue represents revenue recognition on milestone payments received under the company’s Development and Distribution Agreement with Abbott (“Abbott Agreement”). For further details, refer to Supplemental Revenue Information and Guidance Reconciliation: Revenue. |
|
(2) |
For the calculation of Adjusted EBITDA, refer to GAAP to Non-GAAP Reconciliation: EBITDA and Adjusted EBITDA. |
|
(3) |
Product gross profit equals product sales less product costs, as reported on the condensed consolidated statements of operations. Product gross margin equals product gross profit as a percentage of product sales. |
|
(4) |
For the calculation of Non-GAAP net income (loss) and Non-GAAP income (loss) per diluted share (also referred to as Non-GAAP diluted EPS), refer to GAAP to Non-GAAP Reconciliation: Net (Loss) Income and Diluted EPS and Guidance Reconciliation: Non-GAAP Diluted EPS. |
|
(5) |
Represents amortization of business acquisition-related intangible assets and associated tax impact. A significant portion of the business acquisition-related amortization is not tax deductible. |
|
(6) |
Net (loss) income includes the effect of the above adjustments on income tax (expense) benefit, taking into account deferred taxes net of valuation allowances, as well as non-deductible items. Income tax impacts were estimated using the applicable statutory rate (21% in the |
|
(7) |
Diluted weighted average shares outstanding used in the calculation of EPS was the same for GAAP EPS and Non-GAAP EPS for the three months ended |
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