- Q2 2022 revenue of
$15.5 million , Adjusted EBITDA of$6.2 million and cash from operations of$3.5 million . - Total Vascepa prescriptions grew 88% year-over-year, reflecting sequential growth of total and new Vascepa® prescriptions in Q2 2022 of 18% and 30%, respectively.
- 2,400 physicians have prescribed Vascepa, up 131% year-over-year and 19% sequentially: 8,500 patients have taken Vascepa, up 107% year-over-year and 19% sequentially.
Q2 FISCAL 2022 HIGHLIGHTS
- Q2 2022 revenue was
$15.5 million compared to$14.9 million in Q2 2021. - Canadian Product Sales were
$9.5 million , up 7% from Q2 2021 (up 11% in Canadian Dollar terms). - Q2 2022 Adjusted EBITDA was
$6.2 million compared to$6.6 million in Q2 2021. - Q2 2022 net loss was
($9.1) million , or ($0.28 ) per common share, compared to net loss of($2.2) million , or ($0.07 ) per common share, in Q2 2021. - Q2 2022 cash generated from operations was
$3.5 million compared to$1.7 million in Q2 2021. - Cash and cash equivalents were
$21.2 million atJune 30, 2022 essentially unchanged versusDecember 31, 2021 . - Completed a Letter of Intent ("LOI") with the pan-
Canadian Pharmaceutical Alliance ("pCPA") for the terms and conditions under which Vascepa will qualify for public market reimbursement inCanada . - Obtained public reimbursement for Vascepa in
Quebec ,New Brunswick ,Northwest Territories and the Non-Insured Health Benefits (NIHB) program for First Nations and Inuit peoples prior to the end of the fiscal quarter. - Share repurchases under the Company's Normal Course Issuer Bid ("NCIB") of
$0.4 million .
SUBSEQUENT TO QUARTER-END
- Obtained public reimbursement for Vascepa in
Ontario andSaskatchewan . Approximately 70% of publicly covered lives inCanada are now eligible for reimbursement for Vascepa. Quebec prescription growth for Vascepa was 29% in the two-month period following the announcement of public reimbursement compared to the prior two-month period.
"In Q2 we delivered a solid quarter and signed an LOI with the pCPA paving the way for public reimbursement of Vascepa, which we believe will be the single greatest catalyst to realize the growth potential of the product," said
"The onset of public reimbursement allows us to work closely with our partner, Pfizer, to ramp our outreach efforts to the physician community and drive prescription growth of Vascepa. In Q2 we reached new heights in physician interactions, and more than 75% of those were in-person meetings compared to approximately 50% in Q1 2022. The frequency of interaction with physicians is key for driving adoption and in June, on the heels of signing the LOI with the pCPA and after completing the first few public plan agreements, we achieved record monthly call volumes. The combination of public reimbursement along with the expansion of our sales effort will be key factors in the growth of Vascepa prescription volumes in the second half of the year and into 2023."
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 (
Q2 & YEAR-TO-DATE FISCAL 2022 FINANCIAL REVIEW
The Company's Management's Discussion and Analysis and Consolidated Financial Statements for the three- and six-month periods ended
Revenue
The following table provides revenue segmentation by revenue type for the three- and six-month periods ended
Three months ended | Six months ended | |||
2022 | 2021 | 2022 | 2021 | |
Product sales | ||||
| 9,527 | 8,912 | 17,930 | 16,745 |
United States | 3,718 | 3,861 | 7,161 | 7,796 |
13,245 | 12,773 | 25,091 | 24,541 | |
Royalty revenue | 2,287 | 2,172 | 4,997 | 4,718 |
15,532 | 14,945 | 30,088 | 29,259 |
Product Sales
Record Q2 2022 product sales in
Clozaril continues to be the leading treatment for treatment-resistant schizophrenia and the number of patients in
Royalty revenues
Royalty revenues of
Operating Expenses
Three months ended | Six months ended | |||
2022 | 2021 | 2022 | 2021 | |
Cost of product sales | 1,154 | 896 | 2,107 | 1,670 |
Selling and marketing | 4,542 | 3,731 | 8,371 | 6,899 |
Medical, regulatory and patient support | 1,347 | 1,501 | 2,623 | 2,834 |
General and administrative | 2,331 | 2,256 | 4,513 | 4,627 |
9,374 | 8,384 | 17,614 | 16,030 |
Operating expenses in Q2 2022 increased 12% from Q2 2021. Cost of product sales increased due to the year-over-year growth in Vascepa sales. Increased selling and marketing activities reflect additional marketing support costs for Vascepa and initial introductory spending related to
Adjusted EBITDA (1)
Three months ended | Six months ended | |||
2022 | 2021 | 2022 | 2021 | |
Net loss for the period | (9,143) | (2,197) | (12,759) | (6,950) |
Stock-based compensation | 1,230 | (409) | 2,045 | 1,938 |
Amortization and depreciation | 8,489 | 7,480 | 16,876 | 14,847 |
Finance and related costs, net | 1,043 | 1,510 | 1,363 | 2,859 |
Transaction and other costs | 4,542 | — | 4,887 | 84 |
Income tax expense | (3) | 177 | 62 | 451 |
Adjusted EBITDA | 6,158 | 6,561 | 12,474 | 13,229 |
Adjusted EBITDA in Q2 2022 was 6% lower year-over-year due primarily to the increased selling and marketing expense and increased cost of product sales related to the growth in sales of Vascepa.
(1) See "Cautionary Note Regarding Non-IFRS Measures" section of this press release. |
Net Loss
Net loss for Q2 2022 was (
Transaction and other costs largely consisted of a non-cash
Regarding the PERSERIS impairment charge, during the quarter, negotiations with the pCPA concluded without an agreement with respect to public reimbursement for the product. This was a disappointing outcome given that the
Cash from Operations and Financial Position
Cash generated from operations was
HLS has a strong financial position with
Q2 FISCAL 2022 CONFERENCE CALL
HLS will hold a conference call today at
CONFERENCE ID: | 28339844 |
DATE: | |
TIME: | |
DIAL-IN NUMBER: | 1-888-664-6392 or 416-764-8659 |
WEBCAST LINK: | |
TAPED REPLAY: | 1-888-390-0541 or 416-764-8677 |
REPLAY CODE: | 339844 |
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) "transaction costs and other charges", (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
INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION | |||
Unaudited | |||
[in thousands of | |||
As at | As at | ||
ASSETS | |||
Current | |||
Cash and cash equivalents | 21,160 | 21,179 | |
Accounts receivable | 10,710 | 11,511 | |
Inventories | 10,130 | 8,925 | |
Income taxes recoverable | 272 | — | |
Prepaid expenses and other current assets | 2,702 | 2,136 | |
Total current assets | 44,974 | 43,751 | |
Property, plant and equipment | 1,294 | 1,569 | |
Intangible assets | 217,857 | 229,181 | |
Deferred tax asset | 530 | 690 | |
Other non-current assets | 1,973 | 714 | |
Total assets | 266,628 | 275,905 | |
LIABILITIES AND SHAREHOLDERS' EQUITY | |||
Current | |||
Accounts payable and accrued liabilities | 14,097 | 10,596 | |
Provisions | 2,759 | 3,472 | |
Debt and other liabilities | 22,832 | 13,507 | |
Income taxes payable | — | 97 | |
Total current liabilities | 39,688 | 27,672 | |
Debt and other liabilities | 81,619 | 86,844 | |
Deferred tax liability | 922 | 653 | |
Total liabilities | 122,229 | 115,169 | |
Shareholders' equity | |||
Share capital | 266,007 | 265,917 | |
Contributed surplus | 12,625 | 11,717 | |
Accumulated other comprehensive income | 973 | 2,959 | |
Deficit | (135,206) | (119,857) | |
Total shareholders' equity | 144,399 | 160,736 | |
Total liabilities and shareholders' equity | 266,628 | 275,905 | |
INTERIM CONSOLIDATED STATEMENTS OF LOSS | |||||
Unaudited | |||||
[in thousands of | |||||
Three months ended | Six months ended | ||||
2022 | 2021 | 2022 | 2021 | ||
Revenue | 15,532 | 14,945 | 30,088 | 29,259 | |
Expenses | |||||
Cost of product sales | 1,154 | 896 | 2,107 | 1,670 | |
Selling and marketing | 4,542 | 3,731 | 8,371 | 6,899 | |
Medical, regulatory and patient support | 1,347 | 1,501 | 2,623 | 2,834 | |
General and administrative | 2,331 | 2,256 | 4,513 | 4,627 | |
Stock-based compensation | 1,230 | (409) | 2,045 | 1,938 | |
Amortization and depreciation | 8,489 | 7,480 | 16,876 | 14,847 | |
Finance and related costs, net | 1,043 | 1,510 | 1,363 | 2,859 | |
Transaction and other costs | 4,542 | — | 4,887 | 84 | |
Loss before income taxes | (9,146) | (2,020) | (12,697) | (6,499) | |
Income tax expense (recovery) | (3) | 177 | 62 | 451 | |
Net loss for the period | (9,143) | (2,197) | (12,759) | (6,950) | |
Net loss per share: | |||||
Basic and diluted | |||||
INTERIM CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) | ||||
Unaudited | ||||
[in thousands of | ||||
Three months ended | Six months ended | |||
2022 | 2021 | 2022 | 2021 | |
Net loss for the period | (9,143) | (2,197) | (12,759) | (6,950) |
Item that may be reclassified subsequently to net loss | ||||
Unrealized foreign currency translation adjustment | (4,424) | 2,737 | (1,986) | 4,180 |
Comprehensive income (loss) for the period | (13,567) | 540 | (14,745) | (2,770) |
INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY | ||||||||||
Unaudited | ||||||||||
[in thousands of | ||||||||||
Share capital | Contributed surplus | Accumulated other | Deficit | Total | ||||||
Balance, | 265,917 | 11,717 | 2,959 | (119,857) | 160,736 | |||||
Stock options exercised | 236 | (64) | — | — | 172 | |||||
Shares repurchased | (146) | (191) | — | (41) | (378) | |||||
Share purchase obligation | — | (272) | — | — | (272) | |||||
Stock option expense | — | 1,435 | — | — | 1,435 | |||||
Net loss for the period | — | — | — | (12,759) | (12,759) | |||||
Dividends declared | — | — | — | (2,549) | (2,549) | |||||
Unrealized foreign currency | — | — | (1,986) | — | (1,986) | |||||
Balance, | 266,007 | 12,625 | 973 | (135,206) | 144,399 | |||||
Balance, | 257,411 | 11,393 | 2,020 | (101,575) | 169,249 | |||||
Warrants exercised | 2,963 | (192) | — | — | 2,771 | |||||
Stock options exercised | 2,901 | (770) | — | — | 2,131 | |||||
Stock option expense | — | 1,043 | — | — | 1,043 | |||||
Net loss for the period | — | — | — | (6,950) | (6,950) | |||||
Dividends declared | — | — | — | (2,594) | (2,594) | |||||
Unrealized foreign currency | — | — | 4,180 | — | 4,180 | |||||
Balance, | 263,275 | 11,474 | 6,200 | (111,119) | 169,830 | |||||
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||
Unaudited | ||||
[in thousands of | ||||
Three months ended | Six months ended | |||
2022 | 2021 | 2022 | 2021 | |
OPERATING ACTIVITIES | ||||
Net loss for the period | (9,143) | (2,197) | (12,759) | (6,950) |
Adjustments to reconcile net loss to cash provided by operating activities | ||||
Stock-based compensation | 1,230 | (409) | 2,045 | 1,938 |
Amortization and depreciation | 8,489 | 7,480 | 16,876 | 14,847 |
Impairment charge | 3,051 | — | 3,051 | — |
Accreted interest | 205 | 182 | 412 | 368 |
Fair value adjustment on financial assets and liabilities | (696) | (384) | (2,170) | (695) |
Deferred income taxes | 20 | 59 | 429 | 265 |
Net change in non-cash working capital balances related to operations | 356 | (3,016) | 1,386 | (873) |
Cash provided by operating activities | 3,512 | 1,715 | 9,270 | 8,900 |
INVESTING ACTIVITIES | ||||
Additions to property, plant and equipment | (15) | (9) | (24) | (15) |
Rights acquisitions | — | (2,500) | — | (3,820) |
Other additions to intangible assets | (66) | (23) | (92) | (51) |
Cash used in investing activities | (81) | (2,532) | (116) | (3,886) |
FINANCING ACTIVITIES | ||||
Stock options exercised | 7 | 1,724 | 172 | 2,131 |
Warrants exercised | — | 915 | — | 920 |
Shares repurchased | (357) | — | (378) | — |
Dividends paid | (1,267) | (1,310) | (2,549) | (2,577) |
Repayment of senior secured term loan | (3,000) | (2,250) | (6,000) | (4,500) |
Lease payments | (180) | (162) | (339) | (317) |
Cash used in financing activities | (4,797) | (1,083) | (9,094) | (4,343) |
Net increase (decrease) in cash and cash equivalents during the period | (1,366) | (1,900) | 60 | 671 |
Foreign currency translation | (138) | 44 | (79) | 64 |
Cash and cash equivalents, beginning of period | 22,664 | 23,203 | 21,179 | 20,612 |
Cash and cash equivalents, end of period | 21,160 | 21,347 | 21,160 | 21,347 |
SOURCE
© Canada Newswire, source