Market Newsdesk

MONTREAL, Nov. 13, 2020 (GLOBE NEWSWIRE) — Knight Therapeutics Inc. (TSX: GUD) (“Knight” or “the Company”), a leading pan-American (ex-US) specialty pharmaceutical company, today reported financial results for its third quarter ended September 30, 2020. All currency amounts are in thousands except for share and per share amounts. All currencies are Canadian unless otherwise specified.

Q3 2020 Highlights

Financials

• Revenues were $45,239, an increase of $41,209 or 1,023% over prior year.
• Gross margin was $19,533 or 43% compared to $3,301 or 82% in prior year.
• Interest income generated of $3,188 a decrease of $2,870 or 47% over prior year.
• Adjusted earnings¹ of $6,582, an increase of $1,020 or 18% over prior year.
• Net income for the period was $17,492 compared to a net loss of $2,959 in prior year.

Corporate Developments

• Launched a normal course issuer bid (“NCIB”) in July 2020 and purchased 797,952 common shares for an aggregate cost of $4,745.
• Completed the tender offer process and acquired all of the outstanding Brazilian Depositary Receipts (“BDR”) of Biotoscana Investments S.A. (“GBT”).

Products

• 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.

Strategic Investments

• Received distributions of $14,887 from strategic fund investments and realized a gain of $9,348.

Key Subsequent Event

• Signed a new exclusive distribution agreement with Gilead for the continued commercialization of AmBisome® in Brazil, effective January 1, 2021.

“We are pleased to have completed the GBT acquisition and are knee deep in needed integration work which is complicated by COVID-19. In addition, we remain focused on execution of business development initiatives to in-license and acquire innovative pharmaceuticals for the Canadian and Latin American markets”, said Jonathan Ross Goodman, CEO of Knight Therapeutics Inc.

_____________________
¹Adjusted earnings is not a defined term under IFRS, refer to the definition below for additional details.

SELECT FINANCIAL RESULTS & BALANCE SHEET ITEMS

[In thousands of Canadian dollars]

	Change												Change
	Q3-20		Q3-19		$ 1		%2		YTD-20		YTD-19		$1		%2
Revenues	45,239		4,030		41,209		1,023	%	144,328		10,190		134,138		1,316	%
Gross margin	19,533		3,301		16,232		492	%	61,630		8,519		53,111		623	%
Selling and marketing	7,763		1,146		(6,617	)	577	%	26,928		3,341		(23,587	)	706	%
General and administrative	10,835		4,761		(6,074	)	128	%	27,424		12,339		(15,085	)	122	%
Research and development	2,967		892		(2,075	)	233	%	8,035		2,502		(5,533	)	221	%
Amortization of intangible assets	5,703		424		(5,279	)	1,245	%	17,546		1,273		(16,273	)	1,278	%
Operating loss	(7,735	)	(3,922	)	(3,813	)	97	%	(18,303	)	(10,936	)	(7,367	)	67	%
Interest income	(3,188	)	(6,058	)	(2,870	)	47	%	(11,515	)	(18,108	)	(6,593	)	36	%
Interest expense	822		—		(822	)	N/A		3,070		—		(3,070	)	N/A
Foreign exchange loss	703		638		(65	)	10	%	9,666		3,315		(6,351	)	192	%
Net income (loss)	17,492		(2,959	)	20,451		N/A		23,527		21,186		2,341		11	%
Basic net earnings (loss) per share	0.138		(0.021	)	0.159		N/A		0.256		0.150		0.106		71	%
Adjusted earnings3	6,582		5,562		1,020		18	%	23,510		14,755		8,755		59	%
1 Includes fair value adjustments recorded on the business combination
2 A positive variance represents a positive impact to net income and a negative variance represents a negative impact to net income
3 Percentage change is presented in absolute values

					Change
	09-30-20		12-31-19		$		%1
Cash, cash equivalents, restricted cash and marketable securities	392,352		536,182		(143,830	)	27	%
Trade and other receivables	65,611		108,182		(42,571	)	39	%
Inventory	61,783		70,870		(9,087	)	13	%
Financial assets	173,116		159,151		13,965		9	%
Accounts payable, accrued and other liabilities	44,128		96,156		(52,028	)	54	%
Bank loans	43,407		55,579		(12,172	)	22	%
1 Percentage change is presented in absolute values

Revenue:
For the quarter ended September 30, 2020, GBT’s financial results accounted for $40,574 of incremental revenues ($16,020 in Brazil, $8,497 in Argentina, $7,659 in Colombia and $8,398 in the rest of the Latin American region). The remainder of the growth in revenues of $635 attributable to timing of sales of Impavido^® and the in-licensing of Trelstar^®. The increase in year-to-date revenues is primarily attributed to consolidation of GBT’s financial results as well as the growth in sales of Movantik^®, timing of sales of Impavido^®, and in-licensing of Trelstar^®.

Gross margin:
For the quarter ended September 30, 2020, the gross margin decreased to 43% compared to the same period in the prior year due to consolidation of GBT’s results and an inventory provision of $1,871 due to impact of COVID-19 on certain new product launches. The gross margin would have been 46%, an increase of 3%, from 43% after excluding the adjustment of hyperinflation accounting in accordance with IAS 29.

Selling and marketing:
The increase of $6,617 for the quarter is primarily driven by the consolidation of GBT.

General and administrative:
The increase in general and administrative expenses of $6,074 for the quarter ended September 30, 2020 is due to consolidation of GBT’s financial results which accounted for $4,710 of incremental general and administrative expenses for the three-month ended September 30, 2020. In addition, in Q3-2020 Knight incurred $3,490 in legal and advisory fees in relation to the unified tender offer compared to $2,476 in Q3-2019 for the acquisition of 51.2% of GBT.

Research and development:
GBT’s financial results accounted for $2,006 of incremental research and development expenses for the three-month period ended September 30, 2020.

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 costs and other interest income.  For the quarter, interest income was $3,188 a decrease of 47% or $2,870 compared to the same period prior year. The decrease is due to lower interest rates, average cash and marketable securities balances and average loan balance.

Interest expense:  The consolidation of GBT’s financial results accounted for $822 of incremental interest expense for the three-month period ended September 30, 2020 mainly related to interest on its bank loans.

Net income or loss:  For the quarter net income was $17,492 an increase of $20,451 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 $12,873 (Q3-19 loss of $4,883), (ii) net gain on mandatory tender offer (“MTO”) liability of $10,502 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 $401 due to net monetary positions under hyperinflation accounting.

Adjusted Earnings: For the three-month period ended September 30, 2020, adjusted earnings were $6,582 an increase of $1,020 or 18% 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 September 30, 2020, Knight had $392,352 in cash, cash equivalents and marketable securities, a decrease of $143,830 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.

Trade and other receivables:  As at September 30, 2020, Knight had $65,611 in trade and other receivables, a decrease of $42,571 compared to December 31, 2019 which primarily relates to the net collection of receivables of $24,494 as well as depreciation of Latin American (“LATAM”) currencies of $9,445, and an increase in estimated credit loss provision recorded in 2020 of $2,819. The remaining difference is mainly due to collection of a distribution receivable from a fund investment, a decrease in interest receivable due to timing of the maturities of the marketable securities as well as a decline in interest rates.

Inventory: Overall decrease in inventories of $9,087 as compared to December 31, 2019 is due to increase of $1,516 related net inventory purchases (purchases offset by cost of goods sold) driven by the timing of inventory purchases and new product launches, offset by $3,806 of decrease related to depreciation of LATAM currencies and $6,797 of additional inventory provision recorded in the period ending September 30, 2020.  

Financial assets:  The increase of $13,965 as compared to December 31, 2019 in financial assets is due to the following: (i) increase of $3,859 attributable to loans and receivables as a result of additional loans issued and $883 of gain on foreign exchange (ii) decrease in equity investments, warrants and derivatives of $5,673 due to disposal and revaluation, and (iii) increase of $15,779 attributable to fund investments due to capital calls, foreign exchange gains and mark to market adjustments partially offset by distribution received.

Accounts payable, accrued, and other liabilities: Decrease in accounts payable and accrued liabilities balance of $52,028, or 54% is mainly due payments of inventory purchases, GBT transaction fees, the depreciation of LATAM currencies and lower accrual balance as compared to December 31, 2019 due to timing.

Bank Loans: As at September 30, 2020, bank loans were at $43,407, a decrease of $12,172 mainly due to loan repayment of $8,219 and the foreign exchange revaluation, partially offset by additional loan issued to a subsidiary of GBT.

Product Updates

In September 2020, Knight announced that it has submitted a supplemental NDS to Health Canada for neratinib in combination with capecitabine for the treatment of patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed treatments.

On July 31, 2018, Knight entered into an exclusive licensing agreement for the commercial rights of Imvexxy™ and Bijuva™ in Canada and Israel. Both Imvexxy™ and Bijuva™ were approved by Health Canada during Q3-20.  Imvexxy™, an estradiol vaginal inserts, has been approved for the treatment of postmenopausal moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Bijuva™, a once-daily combination of estradiol and progesterone in a single oral capsule, was approved for the treatment of moderate-to-severe vasomotor symptoms due to menopause. The Company expects to launch both products in 2022

In July 2020, Knight obtained regulatory approval for Lenvima^® (lenvatinib) in Ecuador for the treatment of (i) unresectable hepatocellular carcinoma (HCC); (ii) advanced renal cell carcinoma (RCC), in combination with everolimus; and (iii) differentiated thyroid cancer (DTC).  In addition, in August 2020, the Company obtained regulatory approval for Halaven® in Ecuador for the treatment of patients with metastatic breast cancer.  Through its acquisition of GBT, Knight has the license to Halaven® and Lenvima^® from Eisai for all Latin America excluding Mexico.

On October 26, 2020, the Company announced a new exclusive agreement with Gilead for the commercialization of AmBisome^®. The new agreement is effective starting January 1, 2021. AmBisome^® is a liposomal amphotericin B that is used to treat antifungal infections. This product has been 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 make a NCIB. Under the terms of the 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 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 NCIB. Furthermore, Knight entered into an agreement with a broker to facilitate purchases of its common shares under the 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 three-month period ended September 30, 2020, the Company purchased 797,952 common shares, for an aggregate cash consideration of $4,745, of which $1,009 remains to be settled and 172,642 shares remain to be cancelled as at September 30, 2020. 

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 acquired all the BDRs outstanding.  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: November 13, 2020
Time: 8:30 a.m. ET
Telephone: Telephone: Dial-in information will be provided to participants following pre-registration
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

Please pre-register in advance of the call.

This method will allow you to join the call seconds before it goes live without having to hold for a live agent to pick up your line, which has proven to be an issue with the influx of callers during
the COVID-19 pandemic.

Online pre-registration: http://www.directeventreg.com/registration/event/4687537

Phone pre-registration: 1-(888)-869-1189 and provide the Conference ID: 4687537 to the Live Agent who will take your details.

Once you register, you will receive a confirmation which will have the dial in number and both the Direct Event Passcode and your unique Registrant ID to join this call. For security reasons, please do NOT share this information with anyone else.

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 a controlling stake in Grupo Biotoscana, 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, 2019 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:

Investor Contact:
Knight Therapeutics Inc.
Samira Sakhia	Arvind Utchanah
President & Chief Operating Officer	Chief Financial Officer
T: 514.484.4483 ext.122	T. 514.484.4483 ext. 115
F: 514.481.4116	F. 514.481.4116
Email: info@knighttx.com	Email: info@knighttx.com
Website: www.gud-knight.com	Website: www.gud-knight.com

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:

Q3-20

	Reported under IFRS		Excluding impact of IAS 29		Variance
					$ 1		%2
Revenues	45,239		45,847		(608	)	1	%
Cost of goods sold	25,706		24,765		(941	)	4	%
Gross margin	19,533		21,082		(1,549	)	7	%
Gross margin (%)	43	%	46	%
Expenses
Selling and marketing	7,763		7,604		(159	)	2	%
General and administrative	10,835		10,883		48		0	%
Research and development	2,967		3,026		59		2	%
Amortization of intangible assets	5,703		5,756		53		1	%
Operating Loss	(7,735	)	(6,187	)	(1,548	)	25	%
1 A positive variance represents a positive impact to net income due to the application of IAS 29 and a negative variance represents a negative impact to net income due to the application of IAS 29
2 Percentage change is presented in absolute values

YTD-20

	Reported under IFRS		Excluding impact of IAS 29		Variance
					$ 1		%2
Revenues	144,328		145,860		(1,532	)	1	%
Cost of goods sold	82,698		78,792		(3,906	)	5	%
Gross margin	61,630		67,068		(5,438	)	8	%
Gross margin (%)	43	%	46	%
Expenses
Selling and marketing	26,928		27,021		93		0	%
General and administrative	27,424		26,656		(768	)	3	%
Research and development	8,035		8,175		140		2	%
Amortization of intangible assets	17,546		17,407		(139	)	1	%
Operating Loss	(18,303	)	(12,191	)	(6,112	)	50	%
1 A positive variance represents a positive impact to net income due to the application of IAS 29 and a negative variance represents a negative impact to net income due to the application of IAS 29
2  Percentage change is presented in absolute values

RECONCILIATION TO 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, purchase price allocation accounting, and the impact of IAS 29 (accounting under hyperinflation) but to include costs related to leases.

Adjusted earnings: Operating (loss) income adjusted to exclude amortization and impairment of intangible assets, depreciation, acquisition costs, non-recurring expenses incurred but to include interest income earned net of interest expenses and costs related to leases.

Adjustments to operating (loss) income 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 expenses of $3,490 for the quarter, 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 ended September 30, 2020, Knight recorded one-time costs of $595 related to restructuring activities including severance to certain employees as part of restructuring and integration of GBT
• 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 and excludes Knight’s interest accretion

For the three-month and nine-month periods ended September 30, 2020, the Company calculated adjusted earnings as follows:

	Q3-20		Q3-19		YTD-20		YTD-19
Operating (loss) income	(7,735	)	(3,922	)	(18,303	)	(10,936	)
Adjustments to operating (loss) income:
Amortization of intangible assets	5,703		424		17,546		1,273
Depreciation of property, plant and equipment	1,382		112		4,916		305
Lease costs (IFRS 16 adjustment)	(820	)	(122	)	(2,405	)	(274	)
Impact of PPA accounting	—		—		865		—
Impact of IAS 29	1,601		—		5,973		—
EBITDA	131		(3,508	)	8,592		(9,632	)
Acquisition costs	3,490		2,476		3,810		2,476
Other non-recurring expenses	595		536		2,663		3,803
Interest income	3,188		6,058		11,515		18,108
Interest expense on bank loans	(822	)	—		(3,070	)	—
Adjusted earnings	6,582		5,562		23,510		14,755

INTERIM CONSOLIDATED BALANCE SHEETS

[In thousands of Canadian dollars]
[Unaudited]

	09-30-20		12-31-19
ASSETS
Current
Cash, cash equivalents and restricted cash	218,091		174,268
Marketable securities	158,944		235,045
Trade receivables	51,894		85,845
Other receivables	11,809		17,622
Inventories	61,783		70,870
Prepaids and deposits	2,927		3,306
Other current financial assets	26,248		26,303
Income taxes receivable	6,439		8,265
Total current assets	538,135		621,524
Marketable securities	15,317		126,869
Trade receivables	1,908		4,715
Prepaids and deposits	4,066		4,652
Right-of-use Asset	4,651		6,409
Property, plant and equipment	21,979		22,639
Investment properties	1,439		1,740
Intangible assets	156,641		173,372
Goodwill	77,770		88,262
Other financial assets	146,868		132,848
Deferred income tax assets	1,123		3,991
Other long-term receivables	41,582		41,582
	473,344		607,079
Assets held for sale	2,484		76,700
Total assets	1,013,963		1,305,303

INTERIM CONSOLIDATED BALANCE SHEETS (continued)

[In thousands of Canadian dollars]
[Unaudited]

	09-30-20		12-31-19
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current
Accounts payable and accrued liabilities	42,475		94,406
Lease liabilities	1,089		1,788
Other liabilities	1,270		1,750
Other financial liabilities	—		184,023
Bank loans	41,567		50,557
Income taxes payable	11,828		15,447
Other balances payable	802		2,833
Total current liabilities	99,031		350,804
Accounts payable and accrued liabilities	383		—
Lease liabilities	3,351		4,812
Bank loan	1,840		5,022
Other balances payable	8,495		1,699
Deferred income tax liabilities	18,641		27,860
Total liabilities	131,741		390,197
Equity
Share capital	695,066		723,832
Warrants	117		785
Contributed surplus	18,203		16,463
Accumulated other comprehensive income	2,530		17,405
Retained earnings	166,306		52,246
Attributable to shareholders of the Company	882,222		810,731
Non-controlling interests	—		104,375
Total equity	882,222		915,106
Total liabilities and  Equity	1,013,963		1,305,303

INTERIM CONSOLIDATED STATEMENTS OF INCOME (LOSS)

[In thousands of Canadian dollars, except for share and per share amounts]
[Unaudited]

	Three months ended September 30				Nine months ended September 30
	2020		2019		2020		2019
Revenues	45,239		4,030		144,328		10,190
Cost of goods sold	25,706		729		82,698		1,671
Gross margin	19,533		3,301		61,630		8,519
Expenses
Selling and marketing	7,763		1,146		26,928		3,341
General and administrative	10,835		4,761		27,424		12,339
Research and development	2,967		892		8,035		2,502
Amortization of intangibles	5,703		424		17,546		1,273
Operating loss	(7,735	)	(3,922	)	(18,303	)	(10,936	)
Interest income on financial instruments measured at amortized cost	(1,754	)	(4,825	)	(7,477	)	(14,651	)
Other interest income	(1,434	)	(1,233	)	(4,038	)	(3,457	)
Interest expense	822		—		3,070		—
Other income	(243	)	(1,579	)	(133	)	(1,949	)
Net (gain) loss on financial instruments measured at fair value through profit or loss	(12,873	)	4,883		(22,642	)	(19,649	)
Net gain on mandatory tender offer liability	(10,502	)	—		(12,072	)	—
Realized gain on sale of asset held for sale	—		—		(2,948	)	—
Realized gain on automatic share purchase plan	—		—		(4,168	)	—
Share of net income of associate	—		(128	)	—		(448	)
Foreign exchange loss	703		638		9,666		3,315
Loss on hyperinflation	401		—		1,205		—
Income before income taxes	17,145		(1,678	)	21,234		25,903
Income tax
Current	(3,079	)	999		1,386		3,168
Deferred	2,732		282		(3,679	)	1,549
Income tax (recovery) expense	(347	)	1,281		(2,293	)	4,717
Net income for the period	17,492		(2,959	)	23,527		21,186
Attributable to:
Shareholders of the Company	18,094		(2,959	)	33,834		21,186
Non-controlling interests	(602	)	—		(10,307	)	—
Attributable to shareholders of the Company
Basic (loss) earnings per share	0.138		(0.021	)	0.256		0.150
Diluted (loss) earnings per share	0.138		(0.021	)	0.256		0.150
Weighted average number of common shares outstanding
Basic	130,867,769		137,783,892		132,346,922		141,147,239
Diluted	131,051,220		138,154,629		132,614,809		141,519,892

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

	Three months ended September 30,				Nine months ended September 30,
	2020		2019		2020		2019
OPERATING ACTIVITIES
Net income for the period	17,492		(2,959	)	23,527		21,186
Adjustments reconciling net income to operating cash flows:
Deferred income tax expense (recovery)	2,732		282		(3,679	)	1,549
Share-based compensation expense	725		484		1,422		1,639
Depreciation and amortization	7,085		536		22,462		1,578
Net (gain) loss on financial instruments	(12,873	)	4,883		(22,642	)	(19,649		)
Net gain on mandatory tender offer liability	(10,502	)	—		(12,072	)	—
Realized gain on sale of asset held for sale	—		—		(2,948	)	—
Realized gain on automatic share purchase plan	—		—		(4,168	)	—
Interest expense	822		—		3,070		—
Foreign exchange loss	703		638		9,666		3,315
Loss on hyperinflation	401		—		1,205		—
Share of net income of associate	—		(128	)	—		(448		)
Other adjustments	424		(180	)	(50	)	(363		)
	7,009		3,556		15,793		8,807
Changes in non-cash working capital and other items	(15,413	)	472		(30,974	)	2,368
Other long-term receivable	—		—		—		(18,242		)
Dividends from associate	—		—		—		4,159
Interest payments on bank loans	(8	)	—		(1,321	)	—
Cash (outflow) inflow from operating activities	(8,412	)	4,028		(16,502	)	(2,908		)
INVESTING ACTIVITIES
Acquisition of shares through mandatory tender offer	(170,855	)	—		(170,855	)	—
Purchase of marketable securities	(662	)	(20,300	)	(37,778	)	(203,445		)
Purchase of intangible assets	(1,191	)	(328	)	(14,024	)	(2,317		)
Purchase of property and equipment	(861	)	—		(3,119	)	(4		)
Exercise of warrant investments	—		—		(397	)	—
Issuance of loans receivables	—		(1,987	)	(7,364	)	(20,038		)
Purchase of equity investments	—		—		—		(6		)
Investment in funds	(2,010	)	(5,864	)	(15,010	)	(18,434		)
Proceeds on sale of asset held for sale	—		—		77,000		—
Proceeds on maturity of marketable securities	32,440		90,543		226,999		362,091
Proceeds from repayments of loans receivable	17		873		7,786		3,574
Proceeds from disposal of equity investments	—		1,676		2,919		1,676
Proceeds from distribution of funds	14,887		8,500		26,996		9,177
Cash (outflow) inflow from investing activities	(128,235	)	73,113		93,153		132,274
FINANCING ACTIVITIES
Proceeds from exercise of stock options	115		—		595		—
Proceeds from contributions to share purchase plan	62		62		175		178
Proceeds from repayment of share purchase loans	—		425		—		425
Proceeds from bank loans	—		—		10,998		—
Repurchase of common shares through Normal Course Issuer Bid	(3,736	)	(54,181	)	(35,001	)	(54,181		)
Principal repayment of lease liabilities	(888	)	(68	)	(2,406	)	(205		)
Principal repayments on bank loans	(701	)	—		(8,219	)	—
Cash outflow from financing activities	(5,148	)	(53,762	)	(33,858	)	(53,783		)
(Decrease) increase in cash and cash equivalents during the period	(141,795	)	23,379		42,793		75,583
Cash, cash equivalents and restricted cash, beginning of the period	359,593		294,911		174,268		244,785
Net foreign exchange difference	293		835		1,030		(1,243		)
Cash, cash equivalents and restricted cash, end of the period	218,091		319,125		218,091		319,125
Cash and cash equivalents					218,091		319,125
Short-term marketable securities					158,944		243,790
Long-term marketable securities					15,317		137,177
Total cash, cash equivalents and marketable securities					392,352		700,092

CAMBRIDGE, Mass., Nov. 13, 2020 (GLOBE NEWSWIRE) — Fulcrum Therapeutics, Inc. (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced that management will participate in the following virtual investor conferences:

• Stifel Virtual 2020 Healthcare Conference
  Presentation on Wednesday, November 18, 2020 at 11:20 a.m. ET.

• Piper Sandler 32nd Annual Virtual Healthcare Conference
  Prerecorded Fireside Chat Available on Monday, November 23, 2020 at 10:00 a.m. ET

Audio webcasts of the presentations will be available through the Investor Relations section of the Fulcrum website at https://ir.fulcrumtx.com/events-and-presentations. Archived replays will be available on the Company’s website for 90 days after each conference.

About Fulcrum Therapeutics

Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum’s proprietary product engine identifies drug targets which can modulate gene expression to treat the known root cause of gene mis-expression. The company has advanced losmapimod to Phase 2 clinical development for the treatment of facioscapulohumeral muscular dystrophy (FSHD) and Phase 3 for the treatment of COVID-19. Fulcrum has also advanced FTX-6058, a small molecule designed to increase expression of fetal hemoglobin for the treatment of sickle cell disease and beta thalassemia into Phase 1 clinical development.

Please visit www.fulcrumtx.com.

C
ontact:

Christi Waarich
Director, Investor Relations
and Corporate Communications
617-651-8664
[email protected]

CINCINNATI, Nov. 13, 2020 (GLOBE NEWSWIRE) — Meridian Bioscience, Inc. (NASDAQ: VIVO) today announced financial results for the fourth quarter and fiscal year ended September 30, 2020.

Fourth Quarter 2020 Highlights (Comparison to Fourth Quarter Fiscal 2019):

• Consolidated Net Revenue of $64.2 million, up 26% year-over-year
• Life Science segment delivers revenue of $34.4 million, up 97% year-over-year
• Diagnostics segment revenues decreased 11% year-over-year to $29.8 million, a stronger than expected rebound from Q3 FY20, up 38% quarter-over-quarter
• Launched various SARS-CoV-2 antibody pairs, designed for highly sensitive rapid antigen tests (for saliva and nasopharyngeal samples)

Full Fiscal Year 2020 Highlights (Comparison to Full Year Fiscal 2019):

• Consolidated Net Revenue of $253.7 million, up 26% year-over-year
• Life Science segment delivers record revenue of $132.5 million, up 106% year-over-year, with the contribution of $71.5 million from COVID-19 related products for immunological and molecular tests
• Diagnostics segment revenues decreased 11% year-over-year to $121.1 million, due to headwinds from COVID-19 pandemic in the second half
• Launched the Curian^® analyzer and HpSA^® assay, the first internally developed new product in several years
• Completed assay design lock of a PCR COVID-19 test on the Revogene^® system and preparing submission to the FDA for Emergency Use Authorization
• Closed the acquisition of Exalenz Bioscience, adding the BreathID^® instrument and its Urea Breath Test for H. pylori to the diagnostics product portfolio

Fourth Quarter Fiscal 2020 Results (Comparison to Fourth Quarter Fiscal 2019)

Consolidated revenue for the fourth quarter of fiscal 2020 increased 26% to $64.2 million, compared to $50.8 million last year.  Diagnostics segment revenues rebounded strongly from the pandemic headwinds seen in the third fiscal quarter, but were still down 11% year-over-year.  Life Science segment revenues were up 97%.  Our Diagnostics segment experienced a 23% decrease in revenues from our molecular products and revenues from our non-molecular assay products decreased 8%.  Our Life Science segment revenues for the quarter included $18.1 million in revenue from COVID-19 related products with $14.6 million coming from molecular products and $3.5 million coming from immunological products.

Reported operating income for the fourth quarter of fiscal 2020 was $9.5 million.  Operating expenses included: (i) higher research and development spending in the Diagnostics segment; (ii) acquisition-related costs in connection with the recent Exalenz acquisition; and (iii) purchase accounting amortization related to the acquisition of Exalenz in April 2020, as well as an upward adjustment in the fair value of the earnout obligation for the acquisition of the GenePOC business in 2019.  On an adjusted basis, operating income was $12.0 million, a margin of 19% (see non-GAAP financial measure reconciliation below).    

Jack Kenny, Chief Executive Officer, commented, “This was truly a transformative year for Meridian.  All our hard work over the previous two years prepared us to both weather the storm in Diagnostics and excel as a critical partner to the IVD industry battling a global pandemic.  Heading into fiscal 2021, we will build on the momentum in Diagnostics and continue the strength in Life Science to deliver another record year.”

Full Fiscal Year 2020 Results (Comparison to Full Year Fiscal 2019)

Consolidated revenue for the fiscal year ended September 30, 2020 increased 26% to $253.7 million, compared to $201.0 million in fiscal 2019.  Diagnostics segment revenues were down 11%, while Life Science segment revenues were up 106%.  Our Diagnostics segment experienced a 17% decrease in revenues from our molecular products and revenues from our non-molecular assay products decreased 10%.  Our Life Science segment revenues for the fiscal year included $71.5 million in revenue from COVID-19 related products with $52.2 million coming from molecular products and $19.3 million coming from immunological products.

Reported operating income for fiscal 2020 was $61.3 million.  Operating expenses included: (i) higher research and development spending in the Diagnostics segment; (ii) acquisition-related costs in connection with the recent Exalenz acquisition; and (iii) purchase accounting amortization related to the acquisitions of Exalenz and the GenePOC business in April 2020 and June 2019, respectively, as well as a net downward adjustment in the fair value of the earnout obligation for the acquisition of the GenePOC business.  On an adjusted basis, operating income was $61.7 million, a margin of 24% (see non-GAAP financial measure reconciliation below).   

Bryan Baldasare, Chief Financial Officer, commented, “Fiscal 2020 marked not only a record year in revenues and earnings, but also cash flows from operations, allowing us to repay borrowings under our revolving credit facility and increase our available credit capacity.”

Fiscal 2021 Guidance

Our fiscal 2021 guidance reflects a big rebound of the Diagnostics segment and continued strong demand for our Life Science reagents used in COVID-19 assays.  We expect continued headwinds to our core diagnostics products through the first half, with anticipated full recovery in the second half of the fiscal year.  COVID-19 related diagnostics products are expected to supplement that recovery in the fiscal second quarter.  Life Science demand is expected to be strong throughout fiscal 2021, between $80 and $85 million, albeit, subject to the same quarter-to-quarter volatility that was seen in fiscal 2020.  Adjusted operating margin reflects significant investment in R&D and manufacturing, coupled with costs associated with the acquisition of Exalenz and annualization of headcount increases during fiscal 2020.  Gross margin is expected to be relatively flat on a consolidated basis, reflecting a modest improvement for Diagnostics driven by higher volumes from rebounding demand, and a modest decline for Life Science driven by investments to fortify capacity for larger scale manufacturing.  Diagnostics investment in new product development is forecast to be 18% of Diagnostics revenue as a result of costs for clinical trials delayed from fiscal 2020, which are added to anticipated spend on products advancing through the development pipeline.  Life Science is also investing in infrastructure across sales and R&D to support the new scale of the business.

Revenues

• Consolidated – $290 to $310 million
• Diagnostics segment – $140 to $150 million
• Life Science segment – $150 to $160 million

Adjusted Operating Margin

• Consolidated – 23.5% to 24.5%

Effective Tax Rate

• 23% to 24%

Adjusted Earnings Per Share on a Diluted Basis (based on 44.3M shares)

• $1.14 to $1.28

The higher tax rate compared to 2020 reflects a larger amount of taxable income coming from the United States.  Adjusted operating margin and adjusted earnings per share on a diluted basis for fiscal 2021 exclude costs associated with restructuring activities, changes in the fair value of the earnout obligation and selected legal matters that we expect to continue in fiscal 2021.  Current customer order patterns for our Life Science segment coupled with the current trends with the pandemic, indicate revenues for the segment could favor the first half of the fiscal year and are incorporated in our guidance.  Finally, this guidance reflects our current line of sight and assumes that we do not encounter any significant reductions in manufacturing capacity as a result of the pandemic causing either partial or full site closures for an extended period of time, or adversely affecting our supply chain for raw materials.

Financial Condition

At September 30, 2020, cash and equivalents were $53.5 million and the Company had $91.2 million of borrowing capacity under its $160.0 million commercial bank credit facility.  The Company’s bank-debt obligations under the bank credit facility totaled $68.8 million as of September 30, 2020.

Conference Call Information

Jack Kenny, Chief Executive Officer, and Bryan Baldasare, Executive Vice President and Chief Financial Officer, will host a conference call on Friday, November 13, 2020 beginning at 10:00 a.m. Eastern Time to discuss the fourth quarter and full fiscal year financial results and answer questions.  A presentation to accompany the quarterly and full fiscal year financial results and related discussion will be made available within the Investor Relations section of the Company’s website, www.meridianbioscience.com, prior to the conference call.

To participate in the live call by telephone from the U.S., dial (866) 443-5802, or from outside the U.S., dial (513) 360-6924, and enter the audience pass code 3958286.  A replay will be available for 14 days beginning at 1:00 p.m. Eastern Time on November 13, 2020 by dialing (855) 859-2056 or (404) 537-3406 and entering pass code 3958286.   

FOURTH QUARTER AND FISCAL 2020 UNAUDITED OPERATING RESULTS

(In Thousands, Except per Share Data)

The following table sets forth the unaudited comparative results of Meridian on a U.S. GAAP basis for the interim and annual periods of fiscal 2020 and fiscal 2019.

			Three Months Ended								Twelve Months Ended
			September 30,								September 30,
			2020				2019				2020				2019
Net revenues			$	64,153			$	50,846			$	253,667			$	201,014
Cost of sales				25,822				21,664				97,419				82,286
		Gross profit		38,331				29,182				156,248				118,728
Operating expenses
	Research and development			6,983				5,607				23,729				17,760
	Selling and marketing			7,210				7,140				26,486				27,995
	General and administrative			12,109				8,872				44,345				34,044
	Acquisition-related costs			462				363				3,890				1,808
	Change in fair value of contingent
	consideration obligation			1,135				–				(6,293	)			–
	Restructuring costs			67				1,138				687				2,839
	Selected legal costs			891				213				2,080				1,583
		Total operating expenses		28,857				23,333				94,924				86,029
Operating income				9,474				5,849				61,324				32,699
Other expense, net				(1,727	)			(493	)			(2,031	)			(1,142	)
	Earnings before income taxes			7,747				5,356				59,293				31,557
	Income tax provision			1,254				1,253				13,107				7,175
	Net earnings		$	6,493			$	4,103			$	46,186			$	24,382
Net earnings per basic common share			$	0.15			$	0.10			$	1.08			$	0.57
Basic common shares outstanding				42,940				42,711				42,855				42,571
Net earnings per diluted common share			$	0.15			$	0.10			$	1.07			$	0.57
Diluted common shares outstanding				43,642				42,916				43,174				42,899

					Three Months Ended										Twelve Months Ended
					September 30,										September 30,
					2020					2019					2020					2019
Adjusted Financial Measures
(see non-GAAP financial measure reconciliation below)
Operating income		$			12,029			$		7,563		$			61,688			$		38,929
Net earnings					8,289					5,399					46,301					29,142
Net earnings per diluted common share		$			0.19			$		0.13		$			1.07			$		0.68

Condensed Balance Sheet Data

		September 30,
		2020			2019
Cash and equivalents	$	53,514		$	62,397
Working capital		109,666			123,847
Long-term debt		68,824			75,824
Shareholders’ equity		247,629			190,967
Total assets		405,261			325,478

Segment Data

The following table sets forth the unaudited revenue and segment data for the interim and annual periods in fiscal 2020 and fiscal 2019 (in thousands).

		Three Months Ended										Twelve Months Ended
		September 30,										September 30,
		2020			2019							2020				2019
Net Revenues – By Product Platform/Type
Diagnostics
	Molecular assays	$	4,648		$			6,074				$	21,907			$			26,283
	Non-molecular assays		25,153					27,325					99,225						110,399
	Total Diagnostics		29,801					33,399					121,132						136,682
Life Science
	Molecular reagents		22,703					5,764					78,431						23,261
	Immunological reagents		11,649					11,683					54,104						41,071
	Total Life Science		34,352					17,447					132,535						64,332
	Total Net Revenues	$	64,153		$			50,846				$	253,667			$			201,014

		Three Months Ended													Twelve Months Ended
		September 30,													September 30,
		2020							2019						2020							2019
Net Revenues – By Disease State/Geography
Diagnostics
	Gastrointestinal assays	$		15,396					$		16,958				$		55,040					$		68,982
	Respiratory illness assays			3,030							5,380						26,694							26,622
	Blood chemistry assays			5,026							5,275						17,534							18,639
	Other			6,349							5,786						21,864							22,439
	Total Diagnostics			29,801							33,399						121,132							136,682
Life Science
	Americas			6,795							5,092						37,391							19,441
	EMEA			17,115							7,241						58,125							28,850
	ROW			10,442							5,114						37,019							16,041
	Total Life Science			34,352							17,447						132,535							64,332
	Total Net Revenues	$		64,153					$		50,846				$		253,667					$		201,014
OPERATING INCOME
	Diagnostics	$		(4,174		)			$		2,728				$		3,885					$		25,390
	Life Science			17,234							5,007						68,826							17,581
	Corporate			(3,605		)					(1,923	)					(11,437		)					(10,373	)
	Eliminations			19							37						50							101
	Total Operating Income	$		9,474					$		5,849				$		61,324					$		32,699
	Geographic Regions Americas = North and Latin America EMEA = Europe, Middle East and Africa ROW = Rest of World

NON-GAAP FINANCIAL MEASURES

In this press release, we have supplemented our reported GAAP financial information with information on operating expenses, operating income, operating margin, net earnings, basic earnings per share and diluted earnings per share, each on an adjusted basis excluding the effects of acquisition-related costs, changes in fair value of the contingent consideration obligation, restructuring costs, and selected legal costs, each of which is a non-GAAP measure.  We have provided in the tables below reconciliations to the operating expenses, operating income, net earnings, basic earnings per share and diluted earnings per share amounts reported under U.S. Generally Accepted Accounting Principles for the fourth quarters and fiscal years ended September 30, 2020 and September 30, 2019. 

We believe this information is useful to an investor in evaluating our performance because:

1. These measures help investors to more meaningfully evaluate and compare the results of operations from period to period by removing the impacts of these non-routine items; and
    
2. These measures are used by our management for various purposes, including evaluating performance against incentive bonus achievement targets, comparing performance from period to period in presentations to our board of directors, and as a basis for strategic planning and forecasting.

These non-GAAP measures may be different from non-GAAP measures used by other companies.  In addition, the non-GAAP measures are not based on any comprehensive set of accounting rules or principles.  Non-GAAP measures have limitations, in that they do not reflect all amounts associated with our results as determined in accordance with U.S. GAAP.  Therefore, these measures should only be used to evaluate our results in conjunction with corresponding GAAP measures.

FOURTH QUARTER AND FISCAL YEAR

GAAP TO NON-GAAP RECONCILIATION TABLES

(In Thousands, Except per Share Data)

			Three Months								Twelve Months
			Ended September 30,								Ended September 30,
			2020				2019				2020				2019
Operating Expenses –
	U.S. GAAP basis		$	28,857			$	23,333			$	94,924			$	86,029
	Acquisition-related costs			(462	)			(363	)			(3,890	)			(1,808	)
	Change in fair value of contingent     consideration obligation			(1,135	)			–				6,293				–
	Restructuring costs			(67	)			(1,138	)			(687	)			(2,839	)
	Selected legal costs			(891	)			(213	)			(2,080	)			(1,583	)
	Adjusted Operating Expenses		$	26,302			$	21,619			$	94,560			$	79,799
Operating Income –
	U.S. GAAP basis		$	9,474			$	5,849			$	61,324			$	32,699
	Acquisition-related costs			462				363				3,890				1,808
	Change in fair value of contingent     consideration obligation			1,135				–				(6,293	)			–
	Restructuring costs			67				1,138				687				2,839
	Selected legal costs			891				213				2,080				1,583
	Adjusted Operating Income		$	12,029			$	7,563			$	61,688			$	38,929
Net Earnings –
	U.S. GAAP basis		$	6,493			$	4,103			$	46,186			$	24,382
	Acquisition-related costs, including gain     on currency hedge of purchase price *			212				273				2,751				1,381
	Change in fair value of contingent     consideration obligation *			867				–				(4,726	)			–
	Restructuring costs *			50				864				528				2,169
	Selected legal costs *			667				159				1,562				1,210
	Adjusted Earnings		$	8,289			$	5,399			$	46,301			$	29,142
Basic Earnings per Common Share –
	U.S. GAAP basis		$	0.15			$	0.10			$	1.08			$	0.57
	Acquisition-related costs, including gain     on currency hedge of purchase price			–				0.01				0.06				0.03
	Change in fair value of contingent     consideration obligation			0.02				–				(0.11	)			–
	Restructuring costs			–				0.02				0.01				0.05
	Selected legal costs			0.02				–				0.04				0.03
	Adjusted Basic EPS		$	0.19			$	0.13			$	1.08			$	0.68

			Three Months													Twelve Months
			Ended September 30,													Ended September 30,
			2020							2019						2020							2019
Diluted Earnings per Common Share –
	U.S. GAAP basis		$	0.15						$		0.10				$		1.07					$		0.57
	Acquisition-related costs, including gain     on currency hedge of purchase price			–								0.01						0.06							0.03
	Change in fair value of contingent     consideration obligation			0.02								–						(0.11		)					–
	Restructuring costs			–								0.02						0.01							0.05
	Selected legal costs			0.02								–						0.04							0.03
	Adjusted Diluted EPS		$	0.19						$		0.13				$		1.07					$		0.68
	*    Net of tax.

FORWARD-LOOKING STATEMENTS
The Private Securities Litigation Reform Act of 1995 provides a safe harbor from civil litigation for forward-looking statements accompanied by meaningful cautionary statements. Except for historical information, this report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, which may be identified by words such as “continues”, “estimates”, “anticipates”, “projects”, “plans”, “seeks”, “may”, “will”, “expects”, “intends”, “believes”, “signals”, “should”, “can” and similar expressions or the negative versions thereof and which also may be identified by their context. All statements that address operating performance or events or developments that Meridian expects or anticipates will occur in the future, including, but not limited to, statements relating to per share diluted earnings, sales, product demand, revenue, operating margin, other guidance and the impact of COVID-19 on our business and prospects, are forward-looking statements. Such statements, whether expressed or implied, are based upon current expectations of the Company and speak only as of the date made. Specifically, Meridian’s forward-looking statements are, and will be, based on management’s then-current views and assumptions regarding future events and operating performance. Meridian assumes no obligation to publicly update or revise any forward-looking statements even if experience or future changes make it clear that any projected results expressed or implied therein will not be realized.  These statements are subject to various risks, uncertainties and other factors that could cause actual results to differ materially, including, without limitation, the following:

Meridian’s operating results, financial condition and continued growth depends, in part, on its ability to introduce into the marketplace enhancements of existing products or new products that incorporate technological advances, meet customer requirements and respond to products developed by Meridian’s competition, its ability to effectively sell such products and its ability to successfully expand and effectively manage increased sales and marketing operations. While Meridian has introduced a number of internally developed products and acquired products, there can be no assurance that it will be successful in the future in introducing such products on a timely basis or in protecting its intellectual property, and unexpected or costly manufacturing costs associated with its introduction of new products or acquired products could cause actual results to differ from expectations. Meridian relies on proprietary, patented and licensed technologies. As such, the Company’s ability to protect its intellectual property rights, as well as the potential for intellectual property litigation, would impact its results. Ongoing consolidations of reference laboratories and formation of multi-hospital alliances may cause adverse changes to pricing and distribution. Recessionary pressures on the economy and the markets in which our customers operate, as well as adverse trends in buying patterns from customers, can change expected results. Costs and difficulties in complying with laws and regulations, including those administered by the United States Food and Drug Administration, can result in unanticipated expenses and delays and interruptions to the sale of new and existing products, as can the uncertainty of regulatory approvals and the regulatory process (including the currently ongoing study and other FDA actions regarding the Company’s LeadCare products). The international scope of Meridian’s operations, including changes in the relative strength or weakness of the U.S. dollar and general economic conditions in foreign countries, can impact results and make them difficult to predict. One of Meridian’s growth strategies is the acquisition of companies and product lines. There can be no assurance that additional acquisitions will be consummated or that, if consummated, will be successful and the acquired businesses will be successfully integrated into Meridian’s operations. There may be risks that acquisitions may disrupt operations and may pose potential difficulties in employee retention, and there may be additional risks with respect to Meridian’s ability to recognize the benefits of acquisitions, including potential synergies and cost savings or the failure of acquisitions to achieve their plans and objectives. Meridian cannot predict the outcome of future goodwill impairment testing and the impact of possible goodwill impairments on Meridian’s earnings and financial results. Meridian cannot predict the possible impact of U.S. health care legislation enacted in 2010 – the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act – and any modification or repeal of any of the provisions thereof initiated by Congress or the presidential administration, and any similar initiatives in other countries on its results of operations. Efforts to reduce the U.S. federal deficit, breaches of Meridian’s information technology systems, trade wars, increased tariffs, and natural disasters and other events could have a materially adverse effect on Meridian’s results of operations and revenues. In the past, the Company has identified a material weakness in our internal control over financial reporting, which has been remediated, but the Company can make no assurances that a material weakness will not be identified in the future, which if identified and not properly corrected, could materially adversely affect our operations and result in material misstatements in our financial statements. Meridian also is subject to risks and uncertainties related to disruptions to or reductions in business operations or prospects due to pandemics, epidemics, widespread health emergencies, or outbreaks of infectious diseases such as the coronavirus disease COVID-19.  In addition to the factors described in this paragraph, as well as those factors identified from time to time in our filings with the Securities and Exchange Commission, Part I, Item 1A Risk Factors of our most recent Annual Report on Form 10-K contains a list and description of uncertainties, risks and other matters that may affect the Company. Readers should carefully review these forward-looking statements and risk factors, and not place undue reliance on our forward-looking statements.

About Meridian Bioscience, Inc.

Meridian is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. Through discovery and development, we provide critical life science raw materials used in immunological and molecular tests for human, animal, plant, and environmental applications. Through diagnosis, we provide diagnostic solutions in areas including gastrointestinal and upper respiratory infections and blood lead level testing. We build relationships and provide solutions to hospitals, reference laboratories, research centers, veterinary testing centers, physician offices, diagnostics manufacturers, and biotech companies in more than 70 countries around the world.

Meridian’s shares are traded on the NASDAQ Global Select Market, symbol VIVO. Meridian’s website address is www.meridianbioscience.com.

Contact:

Charlie Wood
Vice President – Investor Relations
Meridian Bioscience, Inc.
Phone:  +1 513.271.3700
Email:  [email protected]

BOSTON JERUSALEM, Nov. 13, 2020 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of orally delivered large molecule therapeutics, announced it will report business and financial results for the quarter ended September 30, 2020 on November 19, 2020, before the U.S. financial markets open.

Entera’s management will host a conference call on Thursday, November 19, 2020 at 8:30 a.m. ET to discuss the results for the quarter. A question-and-answer session will follow Entera’s remarks. To participate on the live call, please dial (855) 547-3865 (US) or (409) 217-8787 (international) and provide the conference ID “9495026” five to ten minutes before the start of the call.

To access a live audio webcast of the presentation on the “Investor Relations” page of Entera’s website, please click here. A replay of the webcast will be archived on Entera’s website for approximately 45 days following the presentation.

About Entera Bio

Entera is a leader in the development of orally delivered large molecule therapeutics for use in areas with significant unmet medical need where adoption of injectable therapies is limited due to cost, convenience and compliance challenges for patients. The Company’s proprietary, oral drug delivery technology is designed to address the technical challenges of poor absorption, high variability, and the inability to deliver large molecules to the targeted location in the body through the use of a synthetic absorption enhancer to facilitate the absorption of large molecules, and protease inhibitors to prevent enzymatic degradation and support delivery to targeted tissues. The Company’s most advanced product candidates, EB613 for the treatment of osteoporosis and EB612 for the treatment of hypoparathyroidism are in Phase 2 clinical development. Entera also licenses its technology to biopharmaceutical companies for use with their proprietary compounds and, to date, has established a collaboration with Amgen Inc. For more information on Entera Bio, visit www.enterabio.com.

Contact:

Jonathan Lieber, CFO
Tel: +001 617-362-3579
[email protected]

Company Management and Principal Investigator of ReSPECT to Discuss Interim Data

Webinar Scheduled for Thursday, November 19, 2020 at 4:30 – 5:30 p.m. ET

AUSTIN, Texas, Nov. 13, 2020 (GLOBE NEWSWIRE) — Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing novel, personalized and targeted therapies for rare and difficult to treat cancers, today announced it will host a webinar on Thursday, November 19, 2020, 4:30 to 5:30 p.m. ET. The call will follow a poster presentation of new interim data from the ongoing National Institutes of Health-sponsored ReSPECT™ Phase 1 clinical trial evaluating the Company’s lead investigational asset, Rhenium NanoLiposome (RNL™), in patients with recurrent glioblastoma (GBM) at the 2020 Society for Neuro-Oncology (SNO) Annual Meeting.

The webinar will feature a discussion of the interim safety, tolerability, dosing, feasibility and efficacy data from the ongoing ReSPECT trial. Andrew J. Brenner, M.D., Ph.D., Associate Professor of Medicine, Neurology, and Neurosurgery at The University of Texas, Health Services Center at San Antonio, will provide an update on the ReSPECT trial and provide insight on the trial data.

Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics, and Gregory D. Stein, M.D., M.B.A., Senior Vice President, Clinical Development of Plus Therapeutics, will discuss the technology behind RNL as well as the current treatment landscape and unmet medical need in treating patients with recurrent GBM.

The sixth and final dose escalation cohort of the ReSPECT trial is underway and is expected to fully enroll by the end of 2020. In September 2020, the FDA granted both Orphan Drug designation and Fast Track designation to RNL for the treatment of patients with recurrent glioblastoma. Additional details about the ReSPECT trial are available at clinicaltrials.gov (NCT01906385).

Webcast Details

A live webinar with accompanying slides will be available in the Events page of the ‘Investors’ section of the Plus Therapeutics website or by clicking here. Individuals can participate in an interactive Q&A session by submitting pertinent questions via the webcast platform.

Please log in approximately 10 minutes prior to the scheduled start time. The archived webcast will be available in the Events section of the Company’s website for 90 days.

A live audio conference will be available by dialing (833) 340-0285 (toll-free) or (236) 712-2475 and entering Conference ID 6095968.

Andrew J. Brenner, M.D., Ph.D.

Dr. Brenner is a nationally known expert in the treatment of brain and breast cancers, with a particular research interest in developing new treatments. He has served on multiple committees and panels including for the National Institutes of Health, National Cancer Institute, Department of Defense Breast Cancer Research Program, and others. He has also served on advisory committees for a number of companies to help direct development of new drugs. His laboratory work developing new treatments has been funded by the Food and Drug Administration, National Cancer Institute, and Cancer Prevention and Research Institute of Texas. He has published nearly 50 original research articles in peer reviewed journals. Dr. Brenner is a member of the Plus Therapeutics Scientific Advisory Board.

About Plus Therapeutics, Inc.

Plus Therapeutics (Nasdaq: PSTV) is a clinical-stage pharmaceutical company whose radiotherapeutic portfolio is concentrated on nanoliposome-encapsulated radionuclides for several cancer targets. Central to the Company’s drug development is a unique nanotechnology platform designed to reformulate, deliver and commercialize multiple drugs targeting rare cancers and other diseases. The platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at PlusTherapeutics.com and ReSPECT-Trials.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains certain statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements, other than statements of historical fact, that address activities, events or developments that we intend, expect, project, believe or anticipate and similar expressions or future conditional verbs such as will, should, would, could or may occur in the future are forward-looking statements. Such statements are based upon certain assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements about: the Company’s potential to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers; the Company’s potential to develop drug candidates currently in its product pipeline; and the Company’s potential to develop additional drugs outside of its current pipeline. The forward-looking statements included in this press release are subject to a number of additional material risks and uncertainties, including but not limited to: the risk that the Company is not able to successfully develop product candidates that can leverage the U.S. FDA’s accelerated regulatory pathways; and the risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.

Investor Contact
Peter Vozzo
Westwicke/ICR
(443) 377-4767
[email protected]

Media Contact
Terri Clevenger
Westwicke/ICR
(203) 856-4326
[email protected]

SAN FRANCISCO, Nov. 13, 2020 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) and affiliate Navire Pharma, Inc. announced today that the first patient has been dosed in a Phase 1 clinical trial of its SHP2 inhibitor (BBP-398) in patients with solid tumors driven by mutations in the MAPK signaling pathway, including RAS and receptor tyrosine kinase genes. BBP-398 was developed through a collaboration with The University of Texas MD Anderson Cancer Center’s Therapeutics Discovery division.

In this two-part Phase 1 study, safety and preliminary anti-tumor activity will be examined. Part 1 is a dose escalation to establish the recommended Phase 2 dose (RP2D) of BBP-398. Part 2 will examine preliminary anti-tumor activity in four cohorts of patients with certain molecular alterations. Those cohorts include advanced KRAS G12C mutant non-small cell lung carcinoma (NSCLC), advanced KRAS G12C mutant non-NSCLC, advanced solid tumors with other MAPK pathway mutations and advanced EGFR-mutant NSCLC. David S. Hong, professor of Investigational Cancer Therapeutics at MD Anderson, will serve as the lead principal investigator for the study.

The primary objective of the study is to evaluate the safety of BBP-398 in advanced cancer patients, with secondary objectives assessing preliminary anti-tumor activity, including objective response rates and duration of response. Patients enrolling in the study must have a diagnosis of advanced (primary or recurrent) or metastatic solid tumor with potentially susceptible genomic alterations in the MAPK pathway (excluding BRAF V600X).

“SHP2 inhibitors have the potential to be effective additions to the therapeutic arsenal for difficult-to-treat cancers by overcoming multiple mechanisms that tumors use to evade treatments,” said Eli Wallace, Ph.D., chief scientific officer of oncology at BridgeBio, Navire’s parent company. “This study is a critical step in understanding the potential that BBP-398 has for patients with tumors driven by RAS or other MAPK-pathway activating mutations and informing our future clinical development activities.”

SHP2, a conserved protein tyrosine phosphatase, plays a critical role in cell signaling and growth, which are important in the progression of cancer. As SHP2 regulates receptor tyrosine kinase signaling pathways commonly overly activated in cancer, targeting SHP2 may offer a potential new approach to treat this disease.

BBP-398 was initially discovered and developed by a team of scientists in MD Anderson’s Institute for Applied Cancer Science (IACS) and Translational Research to Advance Therapeutics and Innovation in Oncology (TRACTION) platforms, both engines within the Therapeutics Discovery division. The ongoing research is supported by Navire through a global licensing and development agreement with MD Anderson.

About BridgeBio Pharma

BridgeBio is a team of experienced drug discoverers, developers and innovators working to create life-altering medicines that target well-characterized genetic diseases at their source. BridgeBio was founded in 2015 to identify and advance transformative medicines to treat patients who suffer from Mendelian diseases, which are diseases that arise from defects in a single gene, and cancers with clear genetic drivers. BridgeBio’s pipeline of over 20 development programs includes product candidates ranging from early discovery to late-stage development. For more information visit bridgebio.com.

About Navire Pharma

Navire Pharma, an affiliate of BridgeBio, in collaboration with MD Anderson’s Therapeutics Discovery division, is developing inhibitors of SHP2 as targeted therapeutics for the treatment of multiple cancers. Together with patients and physicians, the company aims to bring safe, effective treatments to market as quickly as possible. For more information, please visit navirepharma.com

BridgeBio Pharma Forward–Looking Statements
This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements relating to Navire Pharma’s clinical development plans, clinical trial results, timing and completion of clinical trials, Phase 1 study design and objectives, competitive environment, and clinical and therapeutic potential of BBP-398, an SHP2 inhibitor, reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, Navire Pharma’s ability to continue its planned clinical development for BBP-398 and the timing and success of any such continued clinical development, the therapeutic potential of BBP-398, an SHP2 inhibitor, in patients with solid tumors driven by mutations in the MAPK signaling pathway, including RAS and receptor tyrosine kinase genes, and the continuing success of Navire Pharma’s collaboration with The University of Texas MD Anderson Cancer Center’s Institute for Applied Cancer Sciences, as well as those set forth in the Risk Factors section of BridgeBio Pharma, Inc.’s most recent Quarterly Report on Form 10-Q and our other SEC filings. Except as required by law, we and Navire Pharma assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact:

Grace Rauh
BridgeBio Pharma
[email protected]
917-232-5478

Source: BridgeBio Pharma, Inc.