- Q4 2021 revenue of
$15.7 million , Adjusted EBITDA of$6.2 million and cash from operations of$4.0 million - 2021 revenue of
$60.0 million , Adjusted EBITDA of$26.3 million and cash from operations of$16.4 million - Vascepa® prescriptions grew 19% sequentially in Q4 2021 - amid continued COVID-19 disruptions
- 1,710 physicians have prescribed Vascepa, up 25% sequentially and up from 550 at the end of 2020. 6,100 patients have used Vascepa, up 21% sequentially and up from 2,000 at the end of 2020
- HLS is in the final stages of the process for public plan reimbursement of Vascepa. Final outcome is expected within weeks.
Q4 & FISCAL 2021 FINANCIAL HIGHLIGHTS
- Q4 2021 revenue was
$15.7 million compared to$16.5 million in Q4 2020. Fiscal 2021 revenue was$60.0 million compared to$56.1 million in 2020. - Q4 2021 product sales were
$13.2 million compared to$11.9 million in Q4 2020. Fiscal 2021 product sales were$50.6 million compared to$45.7 million in 2020. - Q4 2021 Adjusted EBITDA was
$6.2 million compared to$8.7 million in Q4 2020. Excluding the Q4 2020 Absorica royalties terminatedDecember 31, 2020 , and the$0.5 million one-time realized gain on the acquired royalty receivable, Q4 2020 Adjusted EBITDA was$5.9 million . Fiscal 2021 Adjusted EBITDA was$26.3 million compared to$24.1 million in 2020. - Q4 2021 net loss was
($4.2) million , or ($0.13 ) per common share, compared to net loss of($7.3) million , or ($0.23 ) per common share, in Q4 2020. Fiscal 2021 net loss was($13.1) million , or ($0.41 ) per common share, compared to net loss of($15.3) million , or ($0.48 ) per common share, in 2020. - Q4 2021 cash generated from operations was
$4.0 million compared to$5.8 million in Q4 2020. Fiscal 2021 cash generated from operations was$16.4 million compared to$9.3 million in 2020. - Cash and cash equivalents were
$21.2 million atDecember 31, 2021 compared to$20.6 million atDecember 31, 2020 .
Q4 & FISCAL 2021 BUSINESS HIGHLIGHTS
- Pfizer initiated its promotional activity for Vascepa in late September.
- Vascepa received private payer health plan coverage in
Canada for more than 90% of in-label patients. The Canadian Cardiovascular Society , theCanadian Heart & Stroke Foundation and Thrombosis Canada issued guidelines that strongly recommend the use of icosapent ethyl (Vascepa).- Exceeded Canadian market growth rate with Clozaril patients up 2.5% year-over-year, gaining market share in the process.
- Launched MyCare Therapeutic Drug Monitoring ("TDM") which measures patient drug levels for six of the most common antipsychotics used to treat schizophrenia and bi-polar disorder.
"In fiscal 2021, we made important progress on the roll-out of Vascepa, generated steady and reliable performance from our core products, and advanced other products through the pipeline and towards commercial launch," said
"Among our significant accomplishments with Vascepa during the year, we achieved reimbursement coverage with private payers representing more than 90% of privately covered eligible lives in
"While the Delta and Omicron variants of the COVID-19 virus meant that restrictions were in place during much of the year and into the first two months of 2022, we are encouraged by recent steps that suggest markets could be opening more broadly in
"For 2022, our priorities are to finalize public market access for Vascepa in
"Regarding public market access for Vascepa, we are pleased to report that we are in the final stages of the process for the reimbursement of Vascepa. We can't comment on the outcome today but look forward to providing a more detailed communication and next steps when the outcome becomes public, likely within weeks."
DIVIDEND
On
These dividends paid on the Company's common shares are designated to be "eligible dividends" for purposes of section 89(1) of the Income Tax Act (
Q4 & FISCAL 2021 FINANCIAL REVIEW
The Company's Management's Discussion and Analysis and Consolidated Financial Statements for the three-and twelve-month periods ended
Revenue
The following table provides revenue segmentation by revenue type for the three- and twelve-month periods ended
Three months ended | Year ended | |||
2021 | 2020 | 2021 | 2020 | |
Product sales | ||||
| 9,245 | 7,656 | 34,609 | 29,393 |
| 4,003 | 4,198 | 16,013 | 16,265 |
13,248 | 11,854 | 50,622 | 45,658 | |
Royalty revenue | 2,442 | 4,631 | 9,387 | 10,451 |
15,690 | 16,485 | 60,009 | 56,109 |
Product Sales
Product sales (Vascepa and Clozaril) in Q4 2021 were
Royalty revenues
On
Royalty revenues were
In addition, the Company had a one-time
Operating Expenses
Three months ended | Year ended | |||
2021 | 2020 | 2021 | 2020 | |
Cost of product sales | 1,122 | 1,311 | 3,972 | 3,625 |
Selling and marketing | 4,407 | 3,260 | 14,660 | 12,900 |
Medical, regulatory and patient support | 1,508 | 1,284 | 5,679 | 5,467 |
General and administrative | 2,471 | 2,403 | 9,364 | 10,487 |
9,508 | 8,258 | 33,675 | 32,479 |
Operating expenses in Q4 2021 were
Adjusted EBITDA (1)
Three months ended | Year ended | |||
2021 | 2020 | 2021 | 2020 | |
Net loss for the period | (4,188) | (7,278) | (13,117) | (15,331) |
Stock-based compensation | 529 | 2,420 | 2,354 | 2,531 |
Amortization and depreciation | 8,045 | 9,513 | 30,264 | 33,186 |
Acquisition and transaction costs | 77 | 152 | 169 | 709 |
Finance and related costs, net | 1,048 | 3,372 | 5,355 | 4,012 |
Income tax expense (recovery) | 671 | 557 | 1,309 | (968) |
Adjusted EBITDA | 6,182 | 8,736 | 26,334 | 24,139 |
Adjusted EBITDA in Q4 2021 was
"We are pleased that even in a year of investment for the launch of a major product like Vascepa that we were able to maintain good cost management throughout the organization and to grow our Adjusted EBITDA for the year," said
(1) See "Cautionary Note Regarding Non-IFRS Measures" section of this press release. |
Net Loss
Net loss for Q4 2021 was
Cash from Operations and Financial Position
Cash generated from operations was
HLS has a strong financial position with
Q4 FISCAL 2021 CONFERENCE CALL
HLS will hold a conference call today at
CONFERENCE ID: | 86772514 |
DATE: | |
TIME: | |
DIAL-IN NUMBER: | 1-888-664-6392 or 416-764-8659 |
WEBCAST LINK: | https://produceredition.webcasts.com/starthere.jsp?ei=1528259&tp_key=599f8c5ca9 |
TAPED REPLAY: | 1-888-390-0541 or 416-764-8677 |
REPLAY CODE: | 772514 |
The taped replay will be available for 14 days and the archived webcast will be available for 365 days.
A link to the live audio webcast of the conference call will also be available on the events page of the investors section of
ABOUT
Formed in 2015, HLS is a pharmaceutical company focused on the acquisition and commercialization of late-stage development, commercial stage promoted and established branded pharmaceutical products in the North American markets. HLS's focus is on products targeting the central nervous system and cardiovascular therapeutic areas. HLS's management team is composed of seasoned pharmaceutical executives with a strong track record of success in these therapeutic areas and at managing products in each of these lifecycle stages. For more information visit: www.hlstherapeutics.com
1CAUTIONARY NOTE REGARDING NON-IFRS MEASURES
This press release refers to certain non-IFRS measures. These measures are not recognized measures under IFRS, do not have a standardized meaning prescribed by IFRS and are therefore unlikely to be comparable to similar measures presented by other companies. Rather, these measures are provided as additional information to complement those IFRS measures by providing further understanding of HLS's results of operations from management's perspective. Accordingly, they should not be considered in isolation nor as a substitute for analysis of HLS's financial information reported under IFRS. HLS uses non-IFRS measures to provide investors with supplemental measures of its operating performance and thus highlight trends in its core business that may not otherwise be apparent when relying solely on IFRS financial measures. HLS also believes that securities analysts, investors and other interested parties frequently use non-IFRS measures in the evaluation of issuers. HLS's management also uses non-IFRS measures in order to facilitate operating performance comparisons from period to period, prepare annual operating budgets and assess HLS's ability to meet its future debt service, capital expenditure and working capital requirements.
In particular, management uses Adjusted EBITDA as a measure of HLS's performance. To reconcile net income (loss) for the period with Adjusted EBITDA, each of (i) "stock-based compensation", (ii) "amortization and depreciation", (iii) "acquisition and transaction costs", (iv) "finance and related costs", and (v) "income tax expense (recovery)" appearing in the Consolidated Statement of Net Income (Loss) are added to net income (loss) for the period to determine Adjusted EBITDA. Adjusted EBITDA does not have any standardized meaning prescribed by IFRS and is not necessarily comparable to similar measures presented by other companies. Adjusted EBITDA should not be considered in isolation or as a substitute for net income (loss) prepared in accordance with IFRS as issued by the IASB.
FORWARD LOOKING INFORMATION
This release includes forward-looking statements regarding HLS and its business. Such statements are based on the current expectations and views of future events of HLS's management. In some cases the forward-looking statements can be identified by words or phrases such as "may", "will", "expect", "plan", "anticipate", "intend", "potential", "estimate", "believe" or the negative of these terms, or other similar expressions intended to identify forward-looking statements, including, among others, statements with respect to HLS's pursuit of additional product and pipeline opportunities in certain therapeutic markets, statements regarding growth opportunities, expectations regarding financial performance, and the NCIB and ASPP. The forward-looking events and circumstances discussed in this release may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting HLS, including risks relating to the specialty pharmaceutical industry, risks related to the regulatory approval process, economic factors and many other factors beyond the control of HLS. Forward-looking statements and information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause HLS's actual results, performance or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statement or information. Accordingly, readers should not place undue reliance on any forward-looking statements or information. A discussion of the material risks and assumptions associated with this release can be found in the Company's Annual Information Form dated
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION | |||
[in thousands of | |||
As at | As at | ||
ASSETS | |||
Current | |||
Cash and cash equivalents | 21,179 | 20,612 | |
Accounts receivable | 11,511 | 12,497 | |
Inventories | 8,925 | 10,630 | |
Prepaid expenses and other current assets | 2,136 | 2,172 | |
Total current assets | 43,751 | 45,911 | |
Property, plant and equipment | 1,569 | 1,384 | |
Intangible assets | 229,181 | 253,404 | |
Deferred tax asset | 690 | 1,173 | |
Other non-current assets | 714 | 2,034 | |
Total assets | 275,905 | 303,906 | |
LIABILITIES AND SHAREHOLDERS' EQUITY | |||
Current | |||
Accounts payable and accrued liabilities | 10,596 | 14,223 | |
Provisions | 3,472 | 4,516 | |
Debt and other liabilities | 13,507 | 16,358 | |
Income taxes payable | 97 | 545 | |
Total current liabilities | 27,672 | 35,642 | |
Debt and other liabilities | 86,844 | 99,015 | |
Deferred tax liability | 653 | — | |
Total liabilities | 115,169 | 134,657 | |
Shareholders' equity | |||
Share capital | 265,917 | 257,411 | |
Contributed surplus | 11,717 | 11,393 | |
Accumulated other comprehensive income | 2,959 | 2,020 | |
Deficit | (119,857) | (101,575) | |
Total shareholders' equity | 160,736 | 169,249 | |
Total liabilities and shareholders' equity | 275,905 | 303,906 |
CONSOLIDATED STATEMENTS OF NET LOSS | ||||
[in thousands of | ||||
Three months ended | Year ended | |||
2021 | 2020 | 2021 | 2020 | |
Revenues | 15,690 | 16,485 | 60,009 | 56,109 |
Expenses | ||||
Cost of product sales | 1,122 | 1,311 | 3,972 | 3,625 |
Selling and marketing | 4,407 | 3,260 | 14,660 | 12,900 |
Medical, regulatory and patient support | 1,508 | 1,284 | 5,679 | 5,467 |
General and administrative | 2,471 | 2,403 | 9,364 | 10,487 |
Stock-based compensation | 529 | 2,420 | 2,354 | 2,531 |
Amortization and depreciation | 8,045 | 9,513 | 30,264 | 33,186 |
Operating loss | (2,392) | (3,706) | (6,284) | (12,087) |
Realized gain on acquired royalty receivable | — | (509) | — | (509) |
Acquisition and transaction costs | 77 | 152 | 169 | 709 |
Finance and related costs, net | 1,048 | 3,372 | 5,355 | 4,012 |
Loss before income taxes | (3,517) | (6,721) | (11,808) | (16,299) |
Income tax expense (recovery) | 671 | 557 | 1,309 | (968) |
Net loss for the period | (4,188) | (7,278) | (13,117) | (15,331) |
Net loss per share: | ||||
Basic and diluted | ||||
| ||||
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) | ||||
[in thousands of | ||||
Three months ended | Year ended | |||
2021 | 2020 | 2021 | 2020 | |
Net loss for the period | (4,188) | (7,278) | (13,117) | (15,331) |
Item that may be reclassified subsequently to net loss | ||||
Unrealized foreign currency translation adjustment | 798 | 7,385 | 939 | 2,557 |
Comprehensive income (loss) for the period | (3,390) | 107 | (12,178) | (12,774) |
CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY | ||||||
[in thousands of | ||||||
Share capital | Contributed surplus | Accumulated other | Deficit | Total | ||
Balance, | 248,687 | 11,517 | (537) | (81,468) | 178,199 | |
Warrants exercised | 8,663 | (1,652) | — | — | 7,011 | |
Stock options exercised | 61 | (16) | — | — | 45 | |
Stock option expense | — | 1,544 | — | — | 1,544 | |
Net loss for the year | — | — | — | (15,331) | (15,331) | |
Dividends declared | — | — | — | (4,776) | (4,776) | |
Unrealized foreign currency | — | — | 2,557 | — | 2,557 | |
Balance, | 257,411 | 11,393 | 2,020 | (101,575) | 169,249 | |
Warrants exercised | 3,203 | (192) | — | — | 3,011 | |
Stock options exercised | 5,332 | (1,410) | — | — | 3,922 | |
Shares repurchased | (29) | — | — | (18) | (47) | |
Stock option expense | — | 1,926 | — | — | 1,926 | |
Net loss for the year | — | — | — | (13,117) | (13,117) | |
Dividends declared | — | — | — | (5,147) | (5,147) | |
Unrealized foreign currency | — | — | 939 | — | 939 | |
Balance, | 265,917 | 11,717 | 2,959 | (119,857) | 160,736 | |
CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||
[in thousands of | ||||
Three months ended | Year ended | |||
2021 | 2020 | 2021 | 2020 | |
OPERATING ACTIVITIES | ||||
Net loss for the period | (4,188) | (7,278) | (13,117) | (15,331) |
Adjustments to reconcile net loss to cash provided by operating activities | ||||
Stock-based compensation | 529 | 2,420 | 2,354 | 2,531 |
Amortization and depreciation | 8,045 | 9,513 | 30,264 | 33,186 |
Accreted interest | 206 | 261 | 783 | 1,173 |
Fair value adjustment on financial assets and liabilities | (797) | 1,642 | (1,970) | (2,243) |
Unrealized foreign exchange | — | — | — | 176 |
Deferred income taxes | 617 | (131) | 1,136 | (2,483) |
Net change in non-cash working capital balances related to operations | (434) | (581) | (3,021) | (7,665) |
Cash provided by operating activities | 3,978 | 5,846 | 16,429 | 9,344 |
INVESTING ACTIVITIES | ||||
Additions to property, plant and equipment | (22) | (4) | (47) | (36) |
Royalty acquisition | — | (855) | — | (31,692) |
Rights acquisitions | — | (1,825) | (3,820) | (12,050) |
Other additions to intangible assets | (400) | (138) | (643) | (899) |
Cash used in investing activities | (422) | (2,822) | (4,510) | (44,677) |
FINANCING ACTIVITIES | ||||
Stock options exercised | 260 | — | 3,922 | 45 |
Warrants exercised | — | — | 986 | 1,590 |
Shares repurchased | — | — | (47) | — |
Dividends paid | (1,269) | (1,238) | (5,122) | (4,749) |
Drawdown of senior secured term loan | (3,000) | — | — | 20,000 |
Repayment of senior secured term loan | — | (2,250) | (10,500) | (6,132) |
Debt costs | — | — | — | (658) |
Lease payments | (161) | (158) | (637) | (532) |
Cash provided by (used in) financing activities | (4,170) | (3,646) | (11,398) | 9,564 |
Net increase (decrease) in cash and cash equivalents during the period | (614) | (622) | 521 | (25,769) |
Foreign exchange on cash and cash equivalents | 57 | 344 | 46 | (697) |
Cash and cash equivalents, beginning of period | 21,736 | 20,890 | 20,612 | 47,078 |
Cash and cash equivalents, end of period | 21,179 | 20,612 | 21,179 | 20,612 |
SOURCE
© Canada Newswire, source