Knight Therapeutics Reports Fourth Quarter and Year End 2020 Results

Knight Therapeutics Inc. (TSX: GUD) ("Knight" or "the Company"), a leading pan-American (ex-US) specialty pharmaceutical company, today reported financial results for its fourth quarter and year ended December 31, 2020. All currency amounts are in thousands except for share and per share amounts. All currencies are Canadian unless otherwise specified.

2020 Highlights

Financials

• Revenues were $199,519, an increase of $152,058 or 320% over prior year.
• Gross margin was $81,690 or 41% compared to $26,918 or 57% in prior year.
• Adjusted EBITDA ¹ was $16,837 compared to $2,827 in prior year.
• Interest income generated of $14,322 a decrease of $9,220 or 39% over prior year.
• Gain from strategic fund investments of $46,733, of which $16,644 was realized.
• Adjusted earnings ¹ of $28,713, an increase of $2,714 or 10% over prior year.
• Net income was $31,760 compared to net income of $18,033 in prior year.
  

Corporate Developments

• Promoted Arvind Utchanah from VP Finance to CFO.
• Appointed Janice Murray and Nicolás Sujoy on the Board of Directors.
• Disposed of the shares of Medison Biotech (1995) Ltd. for a cash consideration of $77,000 and recorded a gain of $2,948.
• Purchased 5,748,716 common shares at an average price of $6.40 per share through a Normal Course Issuer Bid ("NCIB").
• Completed the tender offer process for an aggregate purchase price of $170,855 and achieved 99.9% ownership of Biotoscana Investments S.A. ("GBT").
  

Products

• Launched Cresemba ^® , indicated for the treatment of invasive aspergillosis and invasive mucormycosis, in Brazil.
• Launched Karfib ^® , indicated for relapsed or refractory multiple myeloma, in Argentina.
• Received regulatory approval from Health Canada for Ibsrela™ for the treatment of Irritable Bowel Syndrome with Constipation ("IBS-C").
• Obtained the exclusive Canadian commercial rights of Trelstar ^® , approved for the treatment of advanced prostate cancer.
• Obtained regulatory approval for Lenvima ^® and Halaven ^® in Ecuador.
• Received regulatory approval from Health Canada for Imvexxy™ and Bijuva™.
• Submitted a supplement to a New Drug Submission ("NDS") of Nerlynx ^® for HER2-positive metastatic breast cancer.
• Signed a new exclusive distribution agreement with Gilead for the continued commercialization of AmBisome ^® in Brazil, effective January 1, 2021.

Strategic Investments

• Disposed of 111,355 common shares of Profound Medical Inc. for total proceeds of $1,825.
• Received US$5,000 for the full repayment of the strategic loan issued to Triumvira Immunologics Inc.
• Amended strategic loan issued to Synergy CHC Corp. and loaned an additional US$2,500.
• Received distributions of $29,128 from strategic fund investments and realized a gain of $16,644.

Key Subsequent Event

• Purchased an additional 2,895,456 common shares at an average price of $5.25 per share through the NCIB.
• Disposed of 315,600 common shares of Medexus Pharmaceuticals Inc. for total proceeds of $2,624.
• Announced the Canadian commercial launch of Ibsrela™ for the treatment of IBS-C.
  

"The past year was a transformative year for Knight with the completion of the acquisition of GBT. Despite the challenges due to COVID-19, we continue to progress on integration, while advancing on our product portfolio in both Canada and Latin America. We have received regulatory approvals from Health Canada for Ibsrela™, Imvexxy™ and Bijuva ^® and received regulatory approvals for Lenvima ^® and Halaven ^® in Ecuador. We continue to focus on our mission to acquire, in-license, develop and commercialize innovative medicines and high-quality treatments to improve the health of patients in Latin America and Canada," said Samira Sakhia, President and Chief Operating Officer of Knight Therapeutics Inc.

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_{¹ Adjusted   earnings   and adjusted EBITDA   are   not defined term   s   under IFRS, refer to   the definition   s   below for additional details   .}

SELECT FINANCIAL RESULTS & BALANCE SHEET ITEMS
[In thousands of Canadian dollars]

Revenue: For the quarter ended December 31, 2020, revenues increased by $17,920 or 48% over prior year driven primarily by full quarter consolidation of GBT's financial results compared to one moth in 2019. For the year ended December 31, 2020, revenues increased by $152,058 or 320% as compared to the same period in the prior year driven by the consolidation of GBT's financial results.

Gross margin: For the quarter ended December 31 , 2020, the gross margin decreased from 49% to 36% compared to the same period in the prior year due to the consolidation of GBT's results, change in product mix and an inventory write-off of $3,249 as a result of the impact of COVID-19 on certain new product launches. The gross margin would have been 40%, an increase of 4%, from 36% after excluding the adjustment of hyperinflation accounting in accordance with IAS 29.

For the year ended December 31 , 2020, the gross margin decreased from 57% to 41% compared to the same period in the prior year due to consolidation of GBT's results and an inventory write-off of $10,046 as a result of the impact of COVID-19 on certain new product launches. The gross margin would have been 44%, an increase of 3%, from 41% after excluding the adjustment of hyperinflation accounting in accordance with IAS 29.

Selling and marketing: The increase of $4,209 for the quarter and $27,796 for the twelve-month period ended December 31, 2020 compared to the same prior year periods is primarily driven by the consolidation of GBT's results.

General and administrative: For the year ended December 31, 2020, the general and administrative expenses increased by $14,385 or 59% as compared to the same period in prior year driven by the consolidation of GBT's expenses of $22,052 partially offset by a decrease in one time costs related to the GBT acquisition and the public proxy battle.

Research and development: For the quarter and year ended December 31, 2020, research and development expenses increased by $2,279 or 162% and $7,812 or 200% compared to the same prior year periods. The increase is driven by the consolidation of GBT's financial results and the continued investment in the Canadian product launches.

Amortization of intangible assets: Increase due to the amortization of the definite-life intangible assets acquired in the GBT acquisition.

Interest income: Interest income is the sum of interest income on financial instruments measured at amortized cost and other interest income. For the quarter, interest income was $2,807, a decrease of 48% or $2,627 compared to the same period prior year. For the year, interest income was $14,322 a decrease of 39% or $9,220 compared to the same period in prior year. The decrease in both instances is due to lower interest rates, average cash, marketable securities and strategic loan balances.

Interest expense: The consolidation of GBT's financial results accounted for $3,131 of incremental interest expense for the year ended December 31, 2020 mainly related to interest on its bank loans.

Net income or loss: For the quarter ended December 31, 2020, net income was $8,233 an increase of $11,386 compared to the same period last year. The variance mainly resulted from the above-mentioned items as well as a net gain on the revaluation of financial assets measured at fair value through profit or loss of $25,418 (Q4-19 gain of $1,065).

For the year net income was $31,760 an increase of $13,727 compared to the same period last year. The variance mainly resulted from the above-mentioned items as well as (i) net gain on the revaluation of financial assets measured at fair value through profit or loss of $48,060 (Q4-19 gain of $20,714), (ii) net gain on mandatory tender offer ("MTO") liability of $12,072 mainly driven by the public shareholders of GBT tendering their shares using the Alternative Offer Price at BRL 10.40 per share, (iii) loss on hyperinflation of $1,444 due to net monetary positions under hyperinflation accounting.

Adjusted EBITDA : For the three-month period ended December 31, 2020, adjusted EBITDA was $1,771, a decrease of $4,409 or 71% compared to the same period last year. The variance is mainly explained by an inventory write-off of $3,249 in the fourth quarter of 2020. For the twelve-month period ended December 31, 2020, adjusted EBITDA was $16,837, an increase of $14,010 or 496% compared to the same period last year. For the twelve-month period, the variance is mainly due to the consolidation of GBT's adjusted EBITDA.

Adjusted Earnings : For the three-month period ended December 31, 2020, adjusted earnings were $4,174 a decrease of $7,070 or 63% compared to the same period last year. For the twelve months period ended December 31, 2020, adjusted earnings were $28,713 an increase of $2,714 or 10% as compared to the same period last year. The variance is mainly explained by the incremental adjusted earnings of the GBT acquisition offset by a decline in interest income.

Cash, cash equivalents, restricted cash and marketable securities : As at December 31, 2020, Knight had $392,225 in cash, cash equivalents and marketable securities, a decrease of $143,957 or 27% as compared to December 31, 2019. The variance is primarily due to cash outflows related to the acquisition of the outstanding BDRs of GBT, shares repurchased through NCIB and changes in working capital partially offset by Medison settlement.

Financial assets: The increase of $34,804 for the year ended December 31, 2020 compared to the prior year is due to the following: (i) increase of $2,537 attributable to loans and receivables as a result of additional loans issued partially offset by loss on foreign exchange revaluations and changes in fair value (ii) decrease in equity investments, warrants and derivatives of $3,408 due to disposal and revaluation, and (iii) increase of $35,675 attributable to fund investments.

Bank Loans: As at December 31, 2020, bank loans were at $51,770, a decrease of $3,809 mainly due to loan repayment of $14,714 and a further decrease of $14,178 due to the foreign exchange revaluation, partially offset by additional loans of $24,581 issued in March and December 2020. Subsequent to the year end, loan balance was reduced by $10,111.

Product Updates

On January 8, 2020, Knight announced that the Company entered into an agreement with Debiopharm for the Canadian commercial rights of Trelstar® (triptorelin), for the treatment of advanced prostate cancer and the management and relief of chronic pain associated with endometriosis. On April 20, 2020, the Company announced that it took over commercial activities from Debiopharm's previous partner, Allergan, and is commercializing Trelstar ^® in Canada. According to IQVIA data, Trelstar® sales in Canada were $1,824 for the year ended December 31, 2020 (2019: $2,179).

In the first quarter of 2020 the Company launched Cresemba ^® (isavuconazonium sulfate) in Brazil which was licensed from Basilea Pharmaceuticals for the treatment of invasive aspergillosis and invasive mucormycosis. Knight also launched Karfib ^® (carfilzomib) in Argentina, which is indicated for relapsed or refractory myeloma.

During the year, the Company received a regulatory approval from Health Canada for Ibsrela™ (tenapenor) for the treatment of IBS-C, which was launched subsequent to the year end. Knight also received a regulatory approval for Imvexxy™ (estradiol vaginal inserts) indicated for the treatment of moderate-to-severe dyspareunia and Bijuva™ (estradiol and progesterone) used for the treatment of moderate-to-severe vasomotor symptoms. Knight also submitted a supplement to a NDS of Nerlynx ^® (neratinib) for HER2-positive metastatic breast cancer. Moreover, the Company obtained a regulatory approval for Lenvima ^® (lenvatinib) and Halaven ^® (eribulin mesylate) in Ecuador.

On October 26, 2020, Knight signed a new exclusive distribution agreement with Gilead Sciences Inc. for the commercialization of AmBisome ^® (liposomal amphotericin B) in Brazil. The agreement will be effective starting January 1, 2021. This product has been a part of Knight's Brazilian affiliate's portfolio for over twenty years.

NCIB

On July 10, 2020, the Company announced that the Toronto Stock Exchange approved its notice of intention to launch an additional NCIB (‘2020 NCIB"). Under the terms of the 2020 NCIB, Knight may purchase for cancellation up to 10,856,710 common shares of the Company which represented 10% of its public float as at July 6, 2020. The 2020 NCIB commenced on July 14, 2020 and will end on the earlier of July 13, 2021 or when the Company completes its maximum purchases under the 2020 NCIB. Furthermore, Knight entered into an agreement with a broker to facilitate purchases of its common shares under the 2020 NCIB. Under Knight's automatic share purchase plan, the broker may purchase common shares which would ordinarily not be permitted due to regulatory restrictions or self-imposed blackout periods. During the twelve -month period ended December 31, 2020, the Company purchased 944,273 common shares under the 2020 NCIB, for an aggregate cash consideration of $5,522. Subsequent to year end, the Company purchased an additional 2,895,456 common shares, of which 1,605,699 remain to be cancelled, for an aggregate cash consideration of $15,206.

Acquisition of GBT

On July 15, 2020, Knight announced the launch of the tender offer for the acquisition and delisting of the remaining 48.8% Brazilian Depository Receipts ("BDRs") of GBT. The public shareholders had the choice between the following two tender options:

• BRL11.23 per BDR with an amount equivalent to 20% deposited in an escrow account to secure the sellers' indemnification obligations under the purchase agreement for the GBT Transaction, provided that BRL 0.91 of the escrow amount shall be mandatorily paid on or at any time prior to November 29, 2022. The escrow amount will be released equally over a period of three years from closing, net of claims in accordance with the terms and conditions of the Share Purchase Agreement.
• BRL10.40 per BDR in cash on the settlement date ("Alternative Offer Price").

Upon close of the tender offer process, 99.6% of the public shareholders tendered their BDRs through the Alternative Offer Price. The Company paid an aggregate purchase price of $170,855 [BRL 537,523] and obtained 99.9% ownership of GBT. On October 23, 2020, the BDR program of GBT was cancelled by the Brazilian Securities and Exchange Commission.

COVID-19 Update

The recent outbreak of the coronavirus, or COVID-19, which has been declared by the World Health Organization to be a pandemic, has spread across the globe and is impacting worldwide economic activity. Certain countries where the Company has significant operations, have required entities to limit or suspend business operations and have implemented travel restrictions and quarantine measures. Knight is continuing to work to alleviate some of the pressure that the global COVID-19 pandemic has placed on our healthcare systems and ensure that we maintain supply of our medicines to patients. The Company and its employees have transitioned to working remotely, including our field sales and medical teams. The Company has taken steps to establish digital and virtual channels to ensure that physicians and patients continue to receive continued support. Knight is developing return to field or office protocols on a country by country basis. Furthermore, the Company has not faced any inventory shortages and has sufficient liquidity to meet all operating requirements for the foreseeable future. As the date hereof, the outbreak has not had a material impact on the Company's results.

Conference Call Notice

Knight will host a conference call and audio webcast to discuss its third quarter results today at 8:30 am ET. Knight cordially invites all interested parties to participate in this call.

Date: Thursday, March 25, 2021
Time: 8:30 a.m. ET
Telephone: : Toll Free 877-876-9176 or International 785-424-1670
Webcast: www.gud-knight.com or Webcast
This is a listen-only audio webcast. Media Player is required to listen to the broadcast.

Replay: An archived replay will be available for 30 days at https://www.gud-knight.com

About Knight Therapeutics Inc.

Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing and commercializing innovative pharmaceutical products for Canada and Latin America. Knight owns Biotoscana Investments S.A., a pan-Latin American specialty pharmaceutical company. Knight Therapeutics Inc.'s shares trade on TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company's web site at www.gud-knight.com or www.sedar.com.

Forward-Looking Statement

This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.'s Annual Report and in Knight Therapeutics Inc.'s Annual Information Form for the year ended December 31, 2020 as filed on www.sedar.com . Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information or future events, except as required by law.

CONTACT INFORMATION:

IMPACT OF HYPERINFLATION
[In thousands of Canadian dollars]

The Company applies IAS 29, Financial Reporting in Hyperinflation Economies, as the Company's Argentine subsidiaries used the Argentine Peso as their functional currency. IAS 29 requires that the financial statements of an entity whose functional currency is the currency of a hyperinflationary economy be adjusted based on an appropriate general price index to express the effects of inflation. If the Company did not apply IAS 29, the effect on the Company's operating income would be as follows:

Q4-20

YTD-20

RECONCILIATION TO ADJUSTED EBITDA AND ADJUSTED EARNINGS
[In thousands of Canadian dollars]

Non-IFRS measure: EBITDA and Adjusted earnings

The Company discloses non-IFRS measures that do not have standardized meanings prescribed by IFRS. The Company believes that shareholders, investment analysts and other readers find such measures helpful in understanding the Company's financial performance and in interpreting the effect of the GBT Transaction on the Company. Non-IFRS financial measures do not have any standardized meaning prescribed by IFRS and may not have been calculated in the same way as similarly named financial measures presented by other companies.

The Company uses the following non-IFRS measures:

EBITDA: Operating (loss) income adjusted to exclude amortization and impairment of intangible assets, depreciation, PPA accounting adjustments, and the impact of IAS 29 (accounting under hyperinflation) but to include costs related to leases. In addition, EBITDA does not reflect the portion of GBT's adjusted earnings attributable to the non-controlling interests.

Adjusted EBITDA: EBITDA adjusted for acquisition costs and non-recurring expenses

Adjusted earnings: Adjusted EBIDTA adjusted to include interest income earned and interest expenses on bank loans.

Adjustments include the following:

• With the adoption of IFRS 16, the lease payments of Knight are not reflected in operating expenses. The IFRS 16 adjustment approximates the cash outflow related to leases of Knight.
• Acquisition costs relate to costs incurred on legal, consulting and advisory fees for the acquisition of GBT.
• Other non-recurring expenses relate to expenses incurred by Knight that are not due to, and are not expected to occur in, the ordinary course of business. For the quarter and the twelve-month period ended December 31, 2020, Knight recorded one-time costs of $2,603 and $5,383 respectively. The expenses related to restructuring activities including severance to certain employees as part of restructuring and integration of GBT, inventory destruction and bad debt against accounts receivable.
• Interest income Includes "Interest income on financial instruments measured at amortized cost" and "Other interest income", primarily from interest earned on loans, cash and cash equivalents, marketable securities and accretion on loans receivable.
• Interest expense on bank loans includes GBT's interest expense mainly related to interest on its bank loans
  

For the three-month and twelve-month periods ended December 31, 2020, the Company calculated adjusted EBITDA and adjusted earnings as follows:

CONSOLIDATED BALANCE SHEETS
[In thousands of Canadian dollars]

CONSOLIDATED BALANCE SHEETS (continued)
[In thousands of Canadian dollars]

CONSOLIDATED STATEMENTS OF INCOME
[In thousands of Canadian dollars, except for share and per share amounts]

CONSOLIDATED STATEMENTS OF CASH FLOWS
[In thousands of Canadian dollars]