Market Newsdesk

November 20, 2020 7:03 am

The RMR Group Inc. Announces Fourth Quarter 2020 Results

The RMR Group Inc. Announces Fourth Quarter 2020 Results

Net Income Attributable to The RMR Group Inc. of $0.38 Per Diluted Share and Adjusted Net Income Attributable to The RMR Group Inc. of $0.39 Per Diluted Share

NEWTON, Mass.–(BUSINESS WIRE)–The RMR Group Inc. (Nasdaq: RMR) today announced its financial results for the fiscal quarter ended September 30, 2020.

Adam Portnoy, President and Chief Executive Officer, made the following statement regarding the fourth quarter fiscal 2020 results:

“In the fiscal fourth quarter, we generated net income of $14.4 million, Adjusted EBITDA of $20.8 million and an Adjusted EBITDA Margin of 48.8%. The sequential quarter increases of 6.1% and 170 basis points in Adjusted EBITDA and Adjusted EBITDA Margin, respectively, were primarily driven by an increase in management services revenues, as the majority of our Managed Equity REITs realized increases in fee paying assets under management, and the implementation of targeted cost containment measures.

Despite the challenges presented by the ongoing pandemic, we believe our Client Companies have sufficient resources to weather near-term challenges. More specifically, at our Managed Equity REITs, rent collections remained strong, rent relief requests are declining and leasing activity is improving. As a result, we believe our Client Companies are well-capitalized and, in some cases, are well positioned to be opportunistic in the near term.

We remain focused on assessing opportunities to grow our private capital assets under management, both organically and through possible external acquisitions. To this end, we recently announced the closing of our inaugural private capital investment vehicle with a large, top tier global sovereign wealth fund. The vehicle has initial investments of $680 million in industrial and logistics properties throughout the U.S., and we expect this investment vehicle may substantially grow in the future. We hope that this new private capital investment vehicle marks the beginning of a new line of business for RMR of managing large amounts of private capital on behalf of institutional clients for investments in core real estate assets. We also ended the fiscal year with $369.7 million of cash and continue to have no debt.”

Fourth Quarter Fiscal 2020 Highlights:

As of September 30, 2020, The RMR Group LLC had $32.3 billion of gross assets under management compared to gross assets under management of $32.9 billion as of September 30, 2019. Fee paying assets under management were $20.6 billion on September 30, 2020 compared to $26.0 billion on September 30, 2019.
Total management and advisory services revenues for the quarter ended September 30, 2020, were $40.2 million, compared to $45.2 million for the quarter ended September 30, 2019.
The RMR Group LLC’s assets under management and management services revenues by source are as follows (dollars in thousands):

	Gross		Fee Paying		Management Services
	AUM		AUM		Revenues
As of or for the Three Months Ended September 30, 2020
Managed Equity REITs ⁽¹⁾	$	29,318,014	$	17,830,148	$	32,705	82.7	%
Managed Operators⁽²⁾	1,939,100		1,939,100		5,676		14.4	%
Other	1,019,040		830,116		1,164		2.9	%
Total	$	32,276,154	$	20,599,364	$	39,545	100.0	%

As of or for the Three Months Ended September 30, 2019
Managed Equity REITs ⁽¹⁾	$	30,102,924	$	23,279,051	$	36,342	82.0	%
Managed Operators⁽²⁾	1,909,164		1,909,164		6,624		14.9	%
Other	912,408		790,746		1,380		3.1	%
Total	$	32,924,496	$	25,978,961	$	44,346	100.0	%

(1)		Managed Equity REITs for the periods presented includes: Diversified Healthcare Trust (DHC), Industrial Logistics Properties Trust (ILPT), Office Properties Income Trust (OPI) and Service Properties Trust (SVC).
(2)		Managed Operators collectively refers to: Five Star Senior Living Inc. (FVE), Sonesta International Hotels Corporation (Sonesta) and TravelCenters of America Inc. (TA).

For the three months ended September 30, 2020, net income was $14.4 million and net income attributable to The RMR Group Inc. was $6.2 million, or $0.38 per diluted share, compared to net income of $18.9 million and net income attributable to The RMR Group Inc. of $8.4 million, or $0.51 per diluted share, for the three months ended September 30, 2019.
For the three months ended September 30, 2020, adjusted net income attributable to The RMR Group Inc. was $6.4 million, or $0.39 per diluted share, compared to $9.6 million, or $0.59 per diluted share, for the three months ended September 30, 2019. The adjustments to net income attributable to The RMR Group Inc. this quarter included $0.6 million, or $0.03 per diluted share, related to certain compensation adjustments, net of reimbursements, and $0.5 million, or $0.03 per diluted share, of separation costs, partially offset by $0.8 million, or $0.05 per diluted share, of unrealized gains on an equity method investment accounted for under the fair value option.
For the three months ended September 30, 2020, Adjusted EBITDA was $20.8 million, Operating Margin was 34.6% and Adjusted EBITDA Margin was 48.8%, compared to Adjusted EBITDA of $28.6 million, Operating Margin of 46.1% and Adjusted EBITDA Margin of 60.2% for the three months ended September 30, 2019.
As of September 30, 2020, The RMR Group Inc. had $369.7 million in cash and cash equivalents with no outstanding debt obligations. Cash and cash equivalents as of September 30, 2020 reflect the payment of annual cash bonuses to officers and employees during the fiscal fourth quarter.

Reconciliations to GAAP:

Adjusted net income attributable to The RMR Group Inc., EBITDA, Adjusted EBITDA and Adjusted EBITDA Margin are non-GAAP financial measures. The GAAP financial measure that is most directly comparable to adjusted net income attributable to The RMR Group Inc. is net income attributable to The RMR Group Inc., the GAAP financial measure that is most directly comparable to EBITDA and Adjusted EBITDA is net income, while the GAAP financial measure that is most directly comparable to Adjusted EBITDA Margin is Operating Margin, which represents operating income divided by total management and advisory services revenues. Reconciliations of net income attributable to The RMR Group Inc. determined in accordance with GAAP to adjusted net income attributable to The RMR Group Inc., and of net income to EBITDA and Adjusted EBITDA as well as calculations of Operating Margin and Adjusted EBITDA Margin for each of the three months ended September 30, 2020 and 2019 are presented later in this press release.

Assets Under Management:

The calculation of gross assets under management, or gross AUM, primarily includes: (i) the gross book value of real estate and related assets, excluding depreciation, amortization, impairment charges or other non-cash reserves, of the Managed Equity REITs and ABP Trust, plus (ii) the gross book value of real estate assets, property and equipment of the Managed Operators, excluding depreciation, amortization, impairment charges or other non-cash reserves, plus (iii) the fair value of investments of Affiliates Insurance Company (until its dissolution on February 13, 2020) and the RMR Office Property Fund LP (until its dissolution on July 28, 2020) and the managed assets of RMR Mortgage Trust and Tremont Mortgage Trust. This calculation of gross AUM may include amounts that are higher than the calculations of assets under management used for purposes of calculating fees under the terms of the business management agreements.

The calculation of fee paying assets under management, or fee paying AUM, refers to the fact that base business management fees payable to The RMR Group LLC by the Managed Equity REITs are calculated monthly based upon the lower of the average historical cost of each entity’s real estate assets and its average market capitalization. Management fees payable to The RMR Group LLC by other client companies are generally calculated as a percentage of revenues earned, average daily managed assets, equity, net asset value or total premiums paid under active insurance policies in accordance with the applicable management agreement.

All references in this press release to assets under management on, or as of, a date are calculated at a point in time.

For additional information on the calculation of assets under management for purposes of the fee provisions of the business management agreements, see The RMR Group Inc.’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission, or SEC. The RMR Group Inc.’s SEC filings are available at the SEC website: www.sec.gov.

Conference Call:

At 10:00 a.m. Eastern Time, President and Chief Executive Officer, Adam Portnoy, and Executive Vice President, Chief Financial Officer and Treasurer, Matt Jordan, will host a conference call to discuss The RMR Group Inc.’s fiscal fourth quarter ended September 30, 2020 financial results.

The conference call telephone number is (877) 329-4297. Participants calling from outside the United States and Canada should dial (412) 317-5435. No pass code is necessary to access the call from either number. Participants should dial in about 15 minutes prior to the scheduled start of the call. A replay of the conference call will be available through 11:59 p.m. Eastern Time on Friday, November 27, 2020. To access the replay, dial (412) 317-0088. The replay pass code is 10148135.

A live audio webcast of the conference call will also be available in a listen only mode on The RMR Group Inc.’s website, at www.rmrgroup.com. Participants wanting to access the webcast should visit The RMR Group Inc.’s website about five minutes before the call. The archived webcast will be available for replay on The RMR Group Inc.’s website following the call for about one week. The transcription, recording and retransmission in any way of The RMR Group Inc.’s fiscal fourth quarter ended September 30, 2020 financial results conference call are strictly prohibited without the prior written consent of The RMR Group Inc.

About The RMR Group Inc.

The RMR Group Inc. is a holding company, and substantially all of its business is conducted by its majority-owned subsidiary, The RMR Group LLC. The RMR Group LLC is an alternative asset manager that primarily provides management services to publicly traded REITs and real estate operating companies. As of September 30, 2020, The RMR Group LLC had $32.3 billion of assets under management, including over 2,100 properties, and employed over 600 real estate professionals in more than 30 offices throughout the United States; and the companies managed by The RMR Group LLC collectively had approximately 42,500 employees. The RMR Group Inc. is headquartered in Newton, Massachusetts.

	Three Months Ended September 30,				Fiscal Year Ended September 30,
	2020		2019		2020		2019
Revenues:
Management services ⁽¹⁾	$	39,545	$	44,346	$	168,766	$	178,075
Incentive business management fees	—		—		—		120,094
Advisory services	659		824		2,911		3,169
Total management and advisory services revenues	40,204		45,170		171,677		301,338
Reimbursable compensation and benefits	17,179		16,622		57,256		57,490
Other client company reimbursable expenses	92,720		97,452		360,572		354,540
Total reimbursable costs	109,899		114,074		417,828		412,030
Total revenues	150,103		159,244		589,505		713,368

Expenses:
Compensation and benefits	31,498		29,006		121,386		114,529
Equity based compensation ⁽²⁾	4,645		4,691		7,828		9,040
Separation costs	1,236		—		1,881		7,050
Total compensation and benefits expense	37,379		33,697		131,095		130,619
General and administrative	5,836		6,594		26,514		28,706
Other client company reimbursable expenses	92,720		97,452		360,572		354,540
Transaction and acquisition related costs	22		425		1,618		698
Depreciation and amortization	237		255		968		1,017
Total expenses	136,194		138,423		520,767		515,580
Operating income	13,909		20,821		68,738		197,788
Interest and other income	349		2,368		4,451		8,770
Impairment loss on Tremont Mortgage Trust investment	—		—		—		(6,213)
Equity in earnings of investees	508		401		1,545		719
Unrealized gain (loss) on equity method investment accounted for under the fair value option	2,235		(1,722)		3,151		(4,700)
Income before income tax expense	17,001		21,868		77,885		196,364
Income tax expense	(2,608)		(2,985)		(11,552)		(27,320)
Net income	14,393		18,883		66,333		169,044
Net income attributable to noncontrolling interest	(8,235)		(10,529)		(37,541)		(94,464)
Net income attributable to The RMR Group Inc.	$	6,158	$	8,354	$	28,792	$	74,580

Weighted average common shares outstanding – basic⁽³⁾	16,214		16,149		16,194		16,132
Weighted average common shares outstanding – diluted⁽³⁾	16,214		16,149		31,194		16,143

Net income attributable to The RMR Group Inc. per common share – basic⁽³⁾	$	0.38	$	0.51	$	1.77	$	4.59
Net income attributable to The RMR Group Inc. per common share – diluted ⁽³⁾	$	0.38	$	0.51	$	1.75	$	4.59

See Notes beginning on page 6.

The RMR Group Inc.

Notes to Consolidated Statements of Income

(dollars in thousands, except per share amounts)

(unaudited)

(1)

Includes business management fees earned from the Managed Equity REITs monthly based upon the lower of (i) the average historical cost of each REIT’s properties and (ii) each REIT’s average market capitalization. The following table presents a summary of each Managed Equity REIT’s primary strategy and the lesser of the historical cost of its assets under management and its market capitalization as of September 30, 2020 and 2019, as applicable:

		Lesser of Historical Cost of Assets
		Under Management or
		Total Market Capitalization ^(a)
		As of September 30,
REIT	Primary Strategy	2020		2019
DHC	Medical office and life science properties, senior living communities and wellness centers	$	4,381,749	$	5,889,907
ILPT	Industrial and logistics properties	2,613,338		2,530,811
OPI	Office properties primarily leased to single tenants, including the government	3,244,624		4,074,202
SVC	Hotels and net lease service and necessity-based retail properties	7,590,437		10,784,131
		$	17,830,148	$	23,279,051

(a)

The basis on which base business management fees are calculated for the three months ended September 30, 2020 and 2019 may differ from the basis at the end of the periods presented in the table above. As of September 30, 2020, the market capitalization was lower than the historical costs of assets under management for DHC, OPI and SVC. The historical costs of assets under management for DHC, OPI and SVC as of September 30, 2020, were $8,486,147, $5,755,652 and $12,462,877, respectively. For ILPT, the historical costs of assets under management were lower than its market capitalization of $2,805,113 as of September 30, 2020.

(2)		Equity based compensation expense for the three months ended September 30, 2020 consists of $1,127 related to shares granted by The RMR Group Inc. to certain of its officers and employees and $3,518 related to Client Companies’ shares granted to certain of The RMR Group Inc.’s officers and employees.

		Equity based compensation related to shares granted by Client Companies is based on the fair value as of the grant date for those shares that have vested, with subsequent changes in the fair value of the unvested grants being recognized over the requisite service periods.

		Equity based compensation related to shares granted by The RMR Group Inc. is based on the market value on the date of grant, with the aggregate value of the shares granted amortized over the applicable vesting period. Shares issued each September vest in five equal, consecutive annual installments, with the first installment vesting on the date of grant. During the three months ended September 30, 2020, The RMR Group Inc. granted 93,700 shares to certain of its officers and employees. As of September 30, 2020, The RMR Group Inc. had 143,990 unvested shares outstanding which are scheduled to vest as follows:

	Number of	Weighted Average
Year	Shares Vesting	Grant Date Fair Value
2021	50,560	$49.74
2022	41,930	$49.47
2023	32,760	$36.72
2024	18,740	$29.79

The RMR Group Inc.

Notes to Consolidated Statements of Income (Continued)

(amounts in thousands, except per share amounts)

(unaudited)

(3)

The RMR Group Inc. calculates earnings per share, or EPS, using the two-class method. As such, earnings attributable to unvested participating shares are excluded from earnings before calculating per share amounts. In addition, diluted EPS includes the assumed issuance of Class A Common Shares pursuant to The RMR Group Inc.’s equity compensation plan and the issuance of Class A Common Shares related to the assumed redemption of the noncontrolling interest’s 15,000 Class A Units using the if-converted method. The calculation of basic and diluted EPS is as follows:

	Three Months Ended September 30,				Fiscal Year Ended September 30,
	2020		2019		2020		2019
Numerators:
Net income attributable to The RMR Group Inc.	$	6,158	$	8,354	$	28,792	$	74,580
Income attributable to unvested participating securities	(43)		(50)		(209)		(482)
Net income attributable to The RMR Group Inc. used in calculating basic EPS	6,115		8,304		28,583		74,098
Effect of dilutive securities:
Add back: net income attributable to noncontrolling interest	—		—		37,541		—
Add back: income tax expense	—		—		11,552		—
Income tax expense at enacted tax rates assuming redemption of noncontrolling interest’s Class A Units for Class A Common Shares	—		—		(23,183)		—
Net income attributable to The RMR Group Inc. used in calculating diluted EPS	$	6,115	$	8,304	$	54,493	$	74,098

Denominators:
Weighted average common shares outstanding – basic	16,214		16,149		16,194		16,132
Effect of dilutive securities:
Assumed redemption of noncontrolling interest’s Class A Units for Class A Common Shares^(a)	—		—		15,000		—
Incremental unvested shares	—		—		—		11
Weighted average common shares outstanding – diluted	16,214		16,149		31,194		16,143

Net income attributable to The RMR Group Inc. per common share – basic	$	0.38	$	0.51	$	1.77	$	4.59
Net income attributable to The RMR Group Inc. per common share – diluted	$	0.38	$	0.51	$	1.75	$	4.59

(a)

For the fiscal year ended September 30, 2020, the assumed redemption of the noncontrolling interest’s Class A Units for Class A Common Shares is dilutive to EPS. For the three months ended September 30, 2020 and the three months and fiscal year ended September 30, 2019, such redemption is not reflected in diluted EPS as the assumed redemption would be anti-dilutive.

The RMR Group Inc.

Reconciliation of Adjusted Net Income Attributable to The RMR Group Inc. from

Net Income Attributable to The RMR Group Inc.

(dollars in thousands, except per share amounts)

(unaudited)

The RMR Group Inc. is providing the reconciliations below and information regarding certain individually significant items occurring or impacting its financial results for the three months ended September 30, 2020 and 2019 for supplemental informational purposes in order to enhance the understanding of The RMR Group Inc.’s consolidated statements of income and to facilitate a comparison of The RMR Group Inc.’s current operating performance with its historical operating performance. This information should be considered in conjunction with net income, net income attributable to The RMR Group Inc. and operating income as presented in The RMR Group Inc.’s consolidated statements of income.

	Three Months Ended September 30, 2020
		Impact on Net Income Attributable to The RMR Group Inc.		Impact on Net Income Attributable to The RMR Group Inc. Per Common Share – Diluted
Net income attributable to The RMR Group Inc.		$	6,158	$	0.38
Unrealized gain on equity method investment accounted for under the fair value option⁽¹⁾		(824)		(0.05)
Certain compensation adjustments, net of reimbursements⁽²⁾		557		0.03
Separation costs⁽³⁾		455		0.03
Transaction and acquisition related costs⁽⁴⁾		8		—
Adjusted net income attributable to The RMR Group Inc.		$	6,354	$	0.39

(1)		Includes $2,235 in unrealized gains on The RMR Group Inc.’s investment in TA common shares, adjusted to reflect amounts attributable to the noncontrolling interest and income tax expense at a rate of approximately 15.3%.
(2)		Includes $1,511 of certain compensation adjustments related to annual bonus estimates, adjusted to reflect amounts attributable to the noncontrolling interest and income tax expense at a rate of approximately 15.3%.
(3)		Includes $1,236 of separation costs, adjusted to reflect amounts attributable to the noncontrolling interest and income tax expense at a rate of approximately 15.3%.
(4)		Includes $22 of transaction and acquisition related costs, adjusted to reflect amounts attributable to the noncontrolling interest and income tax expense at a rate of approximately 15.3%.

	Three Months Ended September 30, 2019
		Impact on Net Income Attributable to The RMR Group Inc.		Impact on Net Income Attributable to The RMR Group Inc. Per Common Share – Diluted
Net income attributable to The RMR Group Inc.		$	8,354	$	0.51
Unrealized loss on equity method investment accounted for under the fair value option⁽¹⁾		662		0.04
Certain compensation adjustments, net of reimbursements ⁽²⁾		371		0.03
Transaction and acquisition related costs ⁽³⁾		163		0.01
Adjusted net income attributable to The RMR Group Inc.		$	9,550	$	0.59

(1)		Includes $1,722 in unrealized losses on The RMR Group Inc.’s investment in TA common shares, adjusted to reflect amounts attributable to the noncontrolling interest and income tax expense at a rate of approximately 13.7%.
(2)		Includes $966 of certain compensation adjustments related to annual bonus estimates, adjusted to reflect amounts attributable to the noncontrolling interest and income tax expense at a rate of approximately 13.7%.
(3)		Includes $425 of transaction and acquisition related costs, adjusted to reflect amounts attributable to the noncontrolling interest and income tax expense at a rate of approximately 13.7%.

The RMR Group Inc. Reconciliation of EBITDA and Adjusted EBITDA from Net Income and Calculation of Operating Margin and Adjusted EBITDA Margin⁽¹⁾(dollars in thousands) (unaudited)

	Three Months Ended September 30,				Fiscal Year Ended September 30,
	2020		2019		2020		2019
Reconciliation of EBITDA and Adjusted EBITDA from net income:
Net income	$	14,393	$	18,883	$	66,333	$	169,044
Income tax expense	2,608		2,985		11,552		27,320
Depreciation and amortization	237		255		968		1,017
EBITDA	17,238		22,123		78,853		197,381
Other asset amortization	2,354		2,354		9,416		9,416
Operating expenses paid in the form of The RMR Group Inc.’s common shares	1,127		1,183		3,480		3,363
Separation costs	1,236		—		1,881		7,050
Transaction and acquisition related costs	22		425		1,618		698
Straight line office rent	30		—		154		—
Impairment loss on Tremont Mortgage Trust investment	—		—		—		6,213
Unrealized (gain) loss on equity method investment accounted for under the fair value option	(2,235)		1,722		(3,151)		4,700
Equity in earnings of investees	(508)		(401)		(1,545)		(719)
Certain compensation adjustments, net of reimbursements	1,511		966		—		—
Incentive business management fees earned	—		—		—		(120,094)
Certain other net adjustments	—		225		(13)		384
Adjusted EBITDA	$	20,775	$	28,597	$	90,693	$	108,392

Calculation of Operating Margin:
Total management and advisory services revenues	$	40,204		$	45,170		$	171,677		$	301,338
Operating income	$	13,909		$	20,821		$	68,738		$	197,788
Operating Margin	34.6		%	46.1		%	40.0		%	65.6		%

Calculation of Adjusted EBITDA Margin:
Contractual management and advisory fees (excluding any incentive business management fees) ⁽²⁾	$	42,558		$	47,524		$	181,093		$	190,660
Adjusted EBITDA	$	20,775		$	28,597		$	90,693		$	108,392
Adjusted EBITDA Margin	48.8		%	60.2		%	50.1		%	56.9		%

(1)		EBITDA, Adjusted EBITDA and Adjusted EBITDA Margin are non-GAAP financial measures calculated as presented in the tables above. The RMR Group Inc. considers EBITDA, Adjusted EBITDA and Adjusted EBITDA Margin to be appropriate supplemental measures of its operating performance, along with net income, net income attributable to The RMR Group Inc., operating income and operating margin. The RMR Group Inc. believes that EBITDA, Adjusted EBITDA and Adjusted EBITDA Margin provide useful information to investors because by excluding the effects of certain amounts, such as those outlined in the tables above, EBITDA, Adjusted EBITDA and Adjusted EBITDA Margin may facilitate a comparison of current operating performance with The RMR Group Inc.’s historical operating performance and with the performance of other asset management businesses. In addition, The RMR Group Inc. believes that providing Adjusted EBITDA Margin may help investors assess The RMR Group Inc.’s performance of its business by providing the margin that Adjusted EBITDA represents to its contractual management and advisory fees (excluding any incentive business management fees). EBITDA, Adjusted EBITDA and Adjusted EBITDA Margin do not represent cash generated by operating activities in accordance with GAAP and should not be considered as alternatives to net income, net income attributable to The RMR Group Inc., operating income or operating margin as an indicator of The RMR Group Inc.’s financial performance or as a measure of The RMR Group Inc.’s liquidity. Other asset management businesses may calculate EBITDA, Adjusted EBITDA and Adjusted EBITDA Margin differently than The RMR Group Inc. does.
(2)		Contractual management and advisory fees are the base business management fees, property management fees and advisory fees The RMR Group Inc. or its subsidiaries earns pursuant to its management and investment advisory agreements with its client companies. These amounts are calculated pursuant to the contractual formulas and do not deduct other asset amortization of $2,354 for each of the three months ended September 30, 2020 and 2019, or $9,416 for each of the fiscal years ended September 30, 2020 and 2019, required to be recognized as a reduction to management services revenues in accordance with GAAP and do not include the incentive business management fees of $120,094 that The RMR Group Inc. recognized under GAAP during the fiscal year ended September 30, 2019, which were earned for the calendar year 2018.

The RMR Group Inc. Consolidated Balance Sheets (dollars in thousands, except per share amounts) (unaudited)

	September 30,
	2020		2019
Assets
Current assets:
Cash and cash equivalents	$	369,663	$	358,448
Due from related parties	82,605		93,521
Prepaid and other current assets	3,877		5,848
Total current assets	456,145		457,817

Property and equipment, net	2,299		2,383
Due from related parties, net of current portion	7,764		9,238
Equity method investment	7,467		6,658
Equity method investment accounted for under the fair value option	12,152		3,682
Goodwill	1,859		1,859
Intangible assets, net of amortization	277		323
Operating lease right of use assets	34,663		—
Deferred tax asset	23,900		25,729
Other assets, net of amortization	143,727		153,143
Total assets	$	690,253	$	660,832

Liabilities and Equity
Current liabilities:
Other client company reimbursable expenses	$	56,079	$	65,909
Accounts payable and accrued expenses	16,984		20,266
Operating lease liabilities	4,407		—
Employer compensation liability	4,298		4,814
Total current liabilities	81,768		90,989

Deferred rent payable, net of current portion	—		1,620
Operating lease liabilities, net of current portion	32,030		—
Amounts due pursuant to tax receivable agreement, net of current portion	27,789		29,950
Employer compensation liability, net of current portion	7,764		9,238
Total liabilities	149,351		131,797

Commitments and contingencies

Equity:
Class A common stock, $0.001 par value; 31,600,000 shares authorized; 15,395,641 and 15,302,710 shares issued and outstanding, respectively	15		15
Class B-1 common stock, $0.001 par value; 1,000,000 shares authorized, issued and outstanding	1		1
Class B-2 common stock, $0.001 par value; 15,000,000 shares authorized, issued and outstanding	15		15
Additional paid in capital	106,622		103,360
Retained earnings	286,249		257,457
Cumulative common distributions	(96,983)		(72,194)
Total shareholders’ equity	295,919		288,654
Noncontrolling interest	244,983		240,381
Total equity	540,902		529,035
Total liabilities and equity	$	690,253	$	660,832

WARNING CONCERNING FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Forward-looking statements can be identified by use of words such as “outlook,” “believe,” “expect,” “potential,” “will,” “may,” “estimate,” “anticipate” and derivatives or negatives of such words or similar words. Forward-looking statements in this press release are based upon present beliefs or expectations. However, forward-looking statements and their implications are not guaranteed to occur and may not occur for various reasons, including some reasons beyond The RMR Group Inc.’s control. For example:

Mr. Portnoy states that in the fiscal fourth quarter, The RMR Group Inc. generated net income of $14.4 million, Adjusted EBITDA of $20.8 million and an Adjusted EBITDA Margin of 48.8%. He also states that the sequential quarter increases of 6.1% and 170 basis points in Adjusted EBITDA and Adjusted EBITDA Margin, respectively, were primarily driven by an increase in management services revenues, as the majority of the Managed Equity REITs realized increases in fee paying assets under management, and the implementation of targeted cost containment measures. These statements may imply that The RMR Group Inc.’s Adjusted EBITDA Margin and revenue may continue to increase in future periods and that The RMR Group Inc. may continue to benefit from increased management services revenue. However, The RMR Group Inc.’s business is subject to various risks, including risks outside its control. Further, the impact and duration of the COVID-19 pandemic is not known and the current difficult economic conditions may continue and could deteriorate further and such adverse conditions may continue for a prolonged period. Accordingly, The RMR Group Inc.’s fee paying assets under management and management services revenues may not grow in future periods and could decline;
Mr. Portnoy also states that, despite the challenges presented by the COVID-19 pandemic, The RMR Group Inc. believes its Client Companies have sufficient resources to weather near-term challenges. He also states that specifically, at the Managed Equity REITs, rent collections remained strong, rent relief requests are declining and leasing activity is improving. Mr. Portnoy further states that, as a result, The RMR Group Inc. believes its Client Companies are well-capitalized, and in some cases, are well positioned to be opportunistic in the near term. These statements may imply that tenant rent collections and tenant relief requests will continue at current levels or improve and that tenant requests for rent relief will further decline. However, tenant rent collections may decline and tenant rent relief requests may increase in the future, particularly if the COVID-19 pandemic does not abate and economic conditions do not sufficiently and sustainably improve. In addition, these tenants may be unable to repay those amounts when due. Further, these and other tenants of the Client Companies may be unable to pay other rent amounts and they may default on those payments or the Client Companies may grant them relief, any of which may reduce or delay the fees The RMR Group Inc. earns. In addition, the Client Companies may not identify opportunities for growth and any opportunities that they do pursue may not be successful; and
Mr. Portnoy states that The RMR Group Inc. remains focused on assessing opportunities to grow its private capital assets under management, both organically and through possible external acquisitions. Mr. Portnoy also states that The RMR Group Inc. recently announced the closing of its inaugural private capital investment vehicle with a large, top tier global sovereign wealth fund. The vehicle has initial investments of $680 million in industrial and logistics properties throughout the U.S., and The RMR Group Inc. expects this investment vehicle may substantially grow in the future. Mr. Portnoy also states that he hopes that this new private capital investment vehicle marks the beginning of a new line of business for The RMR Group Inc. of managing large amounts of private capital on behalf of institutional clients for investments in core real estate assets. These statements may imply that The RMR Group Inc. will be successful in pursuing strategic opportunities, whether internal or external, for future growth, and that The RMR Group Inc.’s business will grow and that its operating performance and financial results will improve as a result. However, The RMR Group Inc. may not identify growth opportunities it wishes to pursue and any growth opportunities it may pursue, including the recently announced closing of The RMR Group Inc.’s inaugural private capital investment vehicle, may not be successful and may not result in The RMR Group Inc. improving its operating performance or its financial results or realizing the returns it expects, and The RMR Group Inc. may realize losses as a result.

The information contained in The RMR Group Inc.’s filings with the SEC, including under the caption “Risk Factors” in The RMR Group Inc.’s periodic reports, or incorporated therein, identifies important factors that could cause differences from the forward-looking statements in this press release. The RMR Group Inc.’s filings with the SEC are available on its website and at www.sec.gov.

You should not place undue reliance on forward-looking statements.

Except as required by law, The RMR Group Inc. undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

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Michael Kodesch, Director, Investor Relations

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November 20, 2020 7:03 am

GE Healthcare Pioneers Photon Counting CT with Prismatic Sensors Acquisition

GE Healthcare Pioneers Photon Counting CT with Prismatic Sensors Acquisition

GE Healthcare invests in a unique approach to cutting-edge CT technology and acquires Prismatic Sensors AB, a leader in Deep Silicon detector technology for photon counting computed tomography (PCCT)

CHICAGO–(BUSINESS WIRE)–
GE Healthcare today announced its acquisition of Prismatic Sensors AB, a Swedish start-up specializing in photon counting detectors, signifying the company’s continued investment in photon counting CT technology. This technology has the potential to establish a new standard of care in oncology, cardiology, neurology, and many other clinical CT applications.

PCCT has the promise to further expand the clinical capabilities of traditional CT, including the visualization of minute details of organ structures, improved tissue characterization, more accurate material density measurement (or quantification) and lower radiation dose. Prismatic Sensors has overcome many challenges working with silicon and patented a novel way to position the silicon sensors “edge on” so the detector is deep enough to absorb very high energy photons and fast enough to count hundreds of millions of CT photons per second. The company was founded in 2012 as a spin-off from KTH Royal Institute of Technology in Stockholm, Sweden.

“We believe this technology has the potential to be a substantial step forward for CT imaging to establish a new standard of care and eventually improve clinical outcomes for millions of patients worldwide,” said Kieran Murphy, President & CEO, GE Healthcare. “From the first x-ray machines to the first photon counting CT prototype, GE Healthcare is committed to pioneering next generation technologies to achieve precision health and improve lives. We are excited about this cutting-edge approach with Deep Silicon and its clinical potential.”

“Our research shows Deep Silicon is the best solution for photon counting CT to meet clinical requirements,” says Mats Danielsson, PhD, CEO of Prismatic Sensors, “Silicon is by far the purest material produced for use in detectors. Alternative materials, including cadmium-based, will be limited as x-ray detector materials due to their imperfect crystal structure and contaminations. Silicon-based detectors will enable superior spectral resolution without compromising on count rate or spatial resolution. Our collaboration with GE Healthcare has been very productive and together, we have made rapid progress. Now, we look forward to the next chapter as we come together as one team working towards bringing photon counting CT with Deep Silicon detectors to the market.”

For nearly 50 years, CT has proven to be a vital imaging tool used to detect cancer, heart conditions, and other diseases large and small. CT’s clinical use and diagnostic power have rapidly increased with the introduction of volumetric imaging, faster rotation speed, iterative and AI-based image reconstruction, as well as dual energy. Last year, the United States reported an all-time high in CT procedure volume with an estimated 91.4 million scans¹. Now, photon counting CT technology may have the potential to define the next 50 years of CT innovation.

“It has been evident for decades that CT (and x-ray imaging) would benefit greatly from energy-discriminating photon counting detectors,” explains Norbert Pelc, Sc.D., Professor of Radiology, Emeritus at Stanford University. “The challenge has been developing detectors that can handle the very high photon flux from high-power x-ray tubes while delivering good energy resolution and maintaining or improving spatial resolution. Of course, the detectors also have to be manufacturable at reasonable cost. It is a huge testament to the scientists and engineers at Prismatic Sensors that they have achieved this. I expect the impact on the CT field will be large, for example, improved dose efficiency, particularly for low dose acquisitions and for applications that benefit from tissue specificity. To put the higher spatial resolution of this Deep Silicon detector in perspective, we have not seen an improvement of this magnitude in decades, and every other time that spatial resolution was improved significantly the utility of CT also advanced. This is very exciting.”

GE researchers began studying PCCT in 1993 and introduced the world’s first PCCT prototype using cadmium-based detectors in 2006. The company has been an industry leader in this technology for Nuclear Medicine for a decade, providing excellent results to clinicians and patients. Now, using Deep Silicon detectors, GE has identified a better solution for CT to accommodate the much higher count-rate demands of CT imaging, thereby providing much more information to clinicians.

“Clinicians rely on the information they receive from medical images – like those we receive from a CT – to help correctly diagnose patients, monitor cases, and make treatment decisions,” explains Staffan Holmin, MD, Professor in Clinical Neuroimaging, Karolinska Institutet and Senior Consultant at Karolinska University Hospital in Sweden. “What’s so exciting about photon counting CT is that it brings higher spatial resolution and contrast. This can help us to image small blood vessels, vascular pathologies, and to see malignant changes at an earlier stage when treatment can be more effective. The potential for substantially reduced radiation is also important, particularly for pediatric patients. Photon counting will likely become the standard of care for all clinical applications where CT is used today.”

GE Healthcare expects to close the Prismatic Sensors acquisition by January 2021, after holding a minority position in the company since 2017. GE Healthcare and Prismatic Sensors will work together to deliver a clinical system in the near future². Terms of the transaction are not disclosed.

For more information on GE Healthcare and this cutting-edge CT technology visit the company’s virtual RSNA booth or gehealthcare.com.

To learn more about Prismatic Sensors, visit prismatic.se.

About GE Healthcare:

GE Healthcare is the $16.7 billion healthcare business of GE (NYSE: GE). As a leading global medical technology and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. With over 100 years of healthcare industry experience and around 50,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world.

Follow us on Facebook, LinkedIn, Twitter, Instagram and Insights for the latest news, or visit our website www.gehealthcare.com for more information.

About Prismatic Sensors AB:

Prismatic Sensors AB is a spin-off company from research at KTH Royal Institute of Technology and Linköping Institute of Technology. The company is focused on research and development of photon counting detectors for CT, providing improved contrast and spatial resolution at reduced radiation dose. Prismatic has many granted patents as well as pending patent applications. Ramsbury Invest was an initial investor along with company employees. Prismatic has offices in Stockholm and Linköping, Sweden. It has cutting edge competency in the design of integrated circuits, high precision mechanical solutions, physics, software, algorithms, as well as mathematics for image reconstruction.

¹ 2019 CT Market Outlook Report by IMV Medical Information Division.

² Technology in development. Not for sale. Not cleared or approved by the U.S. FDA or any other global regulator for commercial availability.

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Margaret Steinhafel

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November 20, 2020 7:03 am

KKR Expands Real Estate Industrial Portfolio in Phoenix with a New Acquisition

KKR Expands Real Estate Industrial Portfolio in Phoenix with a New Acquisition

Investment Increases Phoenix Industrial Footprint to Nearly Two Million Square Feet

NEW YORK–(BUSINESS WIRE)–
KKR, a leading global investment firm, today announced the acquisition of an industrial distribution property in Phoenix for a purchase price of approximately $32 million. The property takes KKR’s industrial footprint in the Phoenix market to nearly two million square feet.

Built in 2001, the asset is a 32-foot clear height, Class A property located in Phoenix’s Southwest Valley. The property was 100% leased at acquisition to a high quality tenant for approximately five and a half years. KKR acquired the asset from Cohen Asset Management and Cushman & Wakefield brokered the transaction.

“This is an important acquisition for us as we continue to develop and diversify our industrial footprint,” said Roger Morales, KKR Partner and Head of Commercial Real Estate Acquisitions in the Americas. “The Phoenix market fundamentals remain highly attractive and we believe the continued acceleration of e-Commerce penetration will drive demand for state of the art distribution centers like this one.”

KKR is making the investment through its Real Estate Partners Americas Fund II.

Across its funds, KKR owns over 16 million square feet of industrial properties in strategic locations across major metropolitan areas in the U.S. Since launching a dedicated real estate platform in 2011, KKR has grown real estate AUM to approximately $14 billion across the U.S., Europe and Asia as of September 30, 2020. The global real estate team consists of over 90 dedicated investment professionals, spanning both the equity and credit businesses.

About KKR

KKR is a leading global investment firm that manages multiple alternative asset classes, including private equity, credit and real assets, with strategic partners that manage hedge funds. KKR aims to generate attractive investment returns for its fund investors by following a patient and disciplined investment approach, employing world-class people, and driving growth and value creation with KKR portfolio companies. KKR invests its own capital alongside the capital it manages for fund investors and provides financing solutions and investment opportunities through its capital markets business. References to KKR’s investments may include the activities of its sponsored funds. For additional information about KKR & Co. Inc. (NYSE: KKR), please visit KKR’s website at www.kkr.com and on Twitter @KKR_Co.

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Cara Major or Miles Radcliffe-Trenner

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November 20, 2020 7:03 am

IMFINZI® (durvalumab)Approved In The US For Less-Frequent, Fixed-Dose Use

IMFINZI® (durvalumab)Approved In The US For Less-Frequent, Fixed-Dose Use

Four-week dosing now approved in all IMFINZIindications, reducing medical visits and improving patient convenience

WILMINGTON, Del.–(BUSINESS WIRE)–
AstraZeneca’s IMFINZI® (durvalumab) has been approved in the US for an additional dosing option, a 1,500mg fixed dose every four weeks, in the approved indications of unresectable Stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy (CRT) and previously treated advanced bladder cancer. This new option is consistent with the approved IMFINZI dosing in extensive-stage small cell lung cancer (ES-SCLC) and will be available to patients weighing more than 30kg as an alternative to the approved weight-based dosing of 10mg/kg every two weeks.

The approval by the Food and Drug Administration (FDA) was based on data from several IMFINZI clinical trials, including the PACIFIC Phase III trial which supported the two-week, weight-based dosing in unresectable Stage III NSCLC, and the CASPIAN Phase III trial which used four-week, fixed-dosing during maintenance treatment in ES-SCLC.^{The decision follows the Priority Review granted by the FDA in August 2020.}

Victoria M. Villaflor, MD, Clinical Professor in the Department of Medical Oncology and Therapeutics Research at City of Hope Cancer Center, Los Angeles, California, said: “This new four-week dosing option gives doctors the choice to cut the number of visits for critical cancer treatment in half and offers a regimen that is more convenient for patients.^{Additionally, it limits potential exposure to infection in the healthcare environment for a population that is especially vulnerable to complications from COVID-19.”}

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: “The approval of this new dosing option across indications reflects our ongoing commitment to improve the patient experience and ensure continuity of care – a priority at all times, but especially during the pandemic. Cancer won’t wait, and it is our job to provide patients with treatment options that acknowledge the challenges the pandemic poses to cancer care, enabling them to visit their physician when truly needed and avoid preventable exposure to healthcare-associated infections.”

The four-week 1,500mg fixed-dosing option forIMFINZIis also under regulatory review in several other countries, including in the EU where the new dosing option was granted accelerated assessment.

IMFINZIis approved in the curative-intent setting of unresectable, Stage III NSCLC after CRT in the US, in the EU, in Japan, in China and in many other countries, based on the PACIFIC Phase III trial. IMFINZI is also approved for previously treated patients with advanced bladder cancer in the US and several other countries. Additionally, it is approved in the US, the EU, Japan and several other countries around the world for the treatment of ES-SCLC based on the CASPIAN Phase III trial.

Important Safety Information

There are no contraindications for IMFINZI^® (durvalumab).

Immune-Mediated Adverse Reactions

Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue IMFINZI depending on severity. See Dosing and Administration for specific details. In general, if IMFINZI requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.

Immune-Mediated Pneumonitis

IMFINZI can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients who did not receive recent prior radiation, the incidence of immune-mediated pneumonitis was 2.0% (28/1414), including fatal (<0.1%), and Grade 3-4 (0.4%) adverse reactions. In patients who received recent prior radiation, the incidence of pneumonitis (including radiation pneumonitis) in patients with unresectable Stage III NSCLC following definitive chemoradiation within 42 days prior to initiation of IMFINZI in PACIFIC was 16.6% (79/475) in patients receiving IMFINZI and 13.2% (31/234) in patients receiving placebo. Of the 79 patients who received IMFINZI, 1.1% were fatal and 2.5% were Grade 3-4 adverse reactions. The frequency and severity of immune-mediated pneumonitis in patients who did not receive definitive chemoradiation prior to IMFINZI were similar in patients who received IMFINZI as a single agent or with ES-SCLC when in combination with chemotherapy.

Immune-Mediated Colitis

IMFINZI can cause immune-mediated colitis that is frequently associated with diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.6% (31/1889) of patients receiving IMFINZI, including Grade 4 (0.1%) and Grade 3 (0.3%) adverse reactions.

Immune-Mediated Hepatitis

IMFINZI can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 1.0% (19/1889) of patients receiving IMFINZI, including fatal (<0.1%) and Grade 3 (0.6%) adverse reactions.

Immune-Mediated Endocrinopathies

Adrenal Insufficiency:IMFINZI can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Immune-mediated adrenal insufficiency occurred in 0.4% (7/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.

Hypophysitis:IMFINZI can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate symptomatic treatment including hormone replacement as clinically indicated. Grade 3 hypophysitis/hypopituitarism occurred in <0.1% (1/1889) of patients who received IMFINZI.

Thyroid Disorders:IMFINZI can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement therapy for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated.

Thyroiditis: Immune-mediated thyroiditis occurred in 0.4% (7/1889) of patients receiving IMFINZI.

Hyperthyroidism: Immune-mediated hyperthyroidism occurred in 1.4% (27/1889) of patients receiving IMFINZI.

Hypothyroidism:Immune-mediated hypothyroidism occurred in 7.3% (137/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.

Type 1 Diabetes Mellitus, which can present with diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Grade 3 immune-mediated type 1 diabetes mellitus occurred in <0.1% (1/1889) of patients receiving IMFINZI.

Immune-Mediated Nephritis with Renal Dysfunction

IMFINZI can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (5/1889) of patients receiving IMFINZI, including Grade 3 (0.1%) adverse reactions.

Immune-Mediated Dermatology Reactions

IMFINZI can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens Johnson Syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), have occurred with PD-1/L-1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes. Immune-mediated rash or dermatitis occurred in 1.6% (30/1889) of patients receiving IMFINZI, including Grade 3 (0.4%) adverse reactions.

Other Immune-Mediated Adverse Reactions

The following clinically significant, immune-mediated adverse reactions occurred at an incidence of less than 1% each in patients who received IMFINZI or were reported with the use of other PD-1/PD-L1 blocking antibodies.

Cardiac/vascular: Myocarditis, pericarditis, vasculitis.

Nervous system: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy.

Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss.

Gastrointestinal: Pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis.

Musculoskeletal and connective tissue disorders: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatic.

Endocrine: Hypoparathyroidism

Other (hematologic/immune): Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection.

Infusion-Related Reactions

IMFINZI can cause severe or life-threatening infusion-related reactions. Monitor for signs and symptoms of infusion-related reactions. Interrupt, slow the rate of, or permanently discontinue IMFINZI based on the severity. See Dosing and Administration for specific details. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses. Infusion-related reactions occurred in 2.2% (42/1889) of patients receiving IMFINZI, including Grade 3 (0.3%) adverse reactions.

Complications of Allogeneic HSCT after IMFINZI

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/L-1 blocking antibody. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/L-1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an allogeneic HSCT.

Embryo-Fetal Toxicity

Based on its mechanism of action and data from animal studies, IMFINZI can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with IMFINZI and for at least 3 months after the last dose of IMFINZI.

Lactation

There is no information regarding the presence of IMFINZI in human milk; however, because of the potential for adverse reactions in breastfed infants from IMFINZI, advise women not to breastfeed during treatment and for at least 3 months after the last dose.

Adverse Reactions

In patients with UC in Study 1108 (n=182), the most common adverse reactions (≥15%) were fatigue (39%), musculoskeletal pain (24%), constipation (21%), decreased appetite (19%), nausea (16%), peripheral edema (15%), and urinary tract infection (15%). The most common Grade 3 or 4 adverse reactions (≥3%) were fatigue, urinary tract infection, musculoskeletal pain, abdominal pain, dehydration, and general physical health deterioration

In patients with UC in Study 1108, discontinuation due to adverse reactions occurred in 3.3% of patients. Serious adverse reactions occurred in 46% of patients. The most frequent serious adverse reactions (>2%) were acute kidney injury (4.9%), urinary tract infection (4.4%), musculoskeletal pain (4.4%), liver injury (3.3%), general physical health deterioration (3.3%), sepsis, abdominal pain, and pyrexia/tumor associated fever (2.7% each)

In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), the most common adverse reactions (≥20%) were cough (40%), fatigue (34%), pneumonitis or radiation pneumonitis (34%), upper respiratory tract infections (26%), dyspnea (25%), and rash (23%). The most common Grade 3 or 4 adverse reactions (≥3%) were pneumonitis/radiation pneumonitis (3.4%) and pneumonia (7%)

In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), discontinuation due to adverse reactions occurred in 15% of patients in the IMFINZI arm. Serious adverse reactions occurred in 29% of patients receiving IMFINZI. The most frequent serious adverse reactions (≥2%) were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%). Fatal pneumonitis or radiation pneumonitis and fatal pneumonia occurred in <2% of patients and were similar across arms

In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), the most common adverse reactions (≥20%) were nausea, fatigue/asthenia, and alopecia. The most common Grade 3 or 4 adverse reaction (≥3%) was fatigue/asthenia (3.4%)

In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), IMFINZI was discontinued due to adverse reactions in 7% of the patients receiving IMFINZI plus chemotherapy. Serious adverse reactions occurred in 31% of patients receiving IMFINZI plus chemotherapy. The most frequent serious adverse reactions reported in at least 1% of patients were febrile neutropenia (4.5%), pneumonia (2.3%), anemia (1.9%), pancytopenia (1.5%), pneumonitis (1.1%), and COPD (1.1%). Fatal adverse reactions occurred in 4.9% of patients receiving IMFINZI plus chemotherapy

The safety and effectiveness of IMFINZI have not been established in pediatric patients.

Indications:

IMFINZI is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who:

Have disease progression during or following platinum-containing chemotherapy.

Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

IMFINZI is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

Please see complete Prescribing Information, including Patient Information.

NOTES TO EDITORS

About Stage III NSCLC

Stage III NSCLC (locally advanced) is commonly divided into three sub-categories (IIIA, IIIB and IIIC), defined by how much the cancer has spread locally and the possibility of surgery.¹ Stage III disease is different from Stage IV disease, where the cancer has spread (metastasized), as the majority of Stage III patients are currently treated with curative intent.^1,2

Stage III NSCLC represents approximately one third of NSCLC incidence and in 2015 was estimated to affect nearly 200,000 patients in the following eight large countries: China, France, Germany, Italy, Japan, Spain, UK, and the US, with approximately 43,000 cases in the US alone.^3,4 The majority of Stage III NSCLC patients are diagnosed with unresectable tumors.⁵ Prior to approval of IMFINZI in this setting, no new treatments beyond CRT had been available to patients for decades.^6-8

About Small cell lung cancer

SCLC is a highly aggressive, fast-growing form of lung cancer that typically recurs and progresses rapidly, despite initial response to chemotherapy.^9,10 About two thirds of SCLC patients are diagnosed with extensive-stage disease, in which the cancer has spread widely through the lung or to other parts of the body.¹¹ Prognosis is particularly poor, as only 6% of all SCLC patients will be alive five years after diagnosis.¹¹

About Bladder cancer

This year, an estimated 81,400 adults in the United States will be diagnosed with bladder cancer.¹² Locally advanced and metastatic bladder cancer remains an area of unmet medical need and typically only one in seven patients is alive five years after diagnosis.¹³Urothelial cancer (UC) is the most common form of bladder cancer.¹⁴ Urothelial cancer (UC) is the most common form of bladder cancer.⁹ Bladder cancer is projected to cause an estimated 17,980 cancer deaths in the US this year.^12,15 PD-L1 is widely expressed in tumor and immune cells in patients with bladder cancer and helps tumors evade detection from the immune system.¹⁶

About IMFINZI® (durvalumab)

IMFINZI is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor’s immune-evading tactics and releasing the inhibition of immune responses.

As part of a broad development program, IMFINZI is also being tested as a monotherapy and in combinations including with tremelimumab, an anti-CTLA4 monoclonal antibody and potential new medicine, as a treatment for patients with NSCLC, SCLC, bladder cancer, head and neck cancer, liver cancer, biliary tract cancer, esophageal cancer, gastric cancer, cervical cancer, ovarian cancer, endometrial cancer and other solid tumors.

About AstraZeneca Support Programs

AstraZeneca strives to ensure that appropriate patients and their oncologists have access to IMFINZI and relevant support resources. These include educational resources, an Oncology Nurse Educator program and affordability and reimbursement programs, such as Access 360™.

Additionally, AstraZeneca has launched Lighthouse, a program that provides support to patients during any immune-mediated adverse events they may encounter during treatment, through medically trained Lighthouse Advocates. The program aims to make patients’ treatment experience as comfortable as possible. Find out more about Lighthouse at LighthouseProgram.com or call 1-855-LHOUSE1 (1-855-546-8731).

About AstraZeneca in lung cancer

AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage development for the treatment of different forms of lung cancer spanning different histologies, several stages of disease, lines of therapy and modes of action.

An extensive Immuno-Oncology (IO) development program focuses on lung cancer patients without a targetable genetic mutation, which represent up to three-quarters of all patients with lung cancer.¹⁷ IMFINZI, an anti-PDL1 antibody, is in development for patients with advanced disease (POSEIDON and PEARL Phase III trials) and for patients in earlier stages of disease, including potentially-curative settings (MERMAID-1, AEGEAN, ADJUVANT BR.31, PACIFIC-2, PACIFIC-4, PACIFIC-5, and ADRIATIC Phase III trials) both as monotherapy and in combination with tremelimumab and/or chemotherapy.

IMFINZI is also in development in the Phase II trials NeoCOAST, COAST and HUDSON in combination with potential new medicines from the early-stage pipeline, including Enhertu (trastuzumab deruxtecan).

About AstraZeneca’s approach to IO

IO is a therapeutic approach designed to stimulate the body’s immune system to attack tumors. The Company’s IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumor immune suppression. AstraZeneca is invested in using IO approaches that deliver long-term survival for new groups of patients across tumor types.

The Company is pursuing a comprehensive clinical-trial program that includes IMFINZI as a monotherapy and in combination with tremelimumab in multiple tumor types, stages of disease, and lines of therapy, and where relevant using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. In addition, the ability to combine the IO portfolio with radiation, chemotherapy, small targeted molecules from across AstraZeneca’s Oncology pipeline, and from research partners, may provide new treatment options across a broad range of tumors.

About AstraZeneca in oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With seven new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers.

By harnessing the power of six scientific platforms – Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response, Antibody Drug Conjugates, Epigenetics, and Cell Therapies – and by championing the development of personalized combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, Cardiovascular, Renal & Metabolism and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS.

References

1. ASCO. Cancer.net. Lung Cancer – Non-Small Cell. Available at: https://www.cancer.net/cancer-types/lung-cancer/view-all. Accessed September 2020.

2. Cheema PK, et al. Perspectives on Treatment Advances For Stage III Locally Advanced Unresectable Non-Small-Cell Lung Cancer. Curr Oncol. 2019;26(1):37-42.

3. Antonia SJ, et al. PACIFIC Investigators. Durvalumab After Chemoradiotherapy In Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017;377(20):1919-1929.

4. EpiCast Report: NSCLC Epidemiology Forecast to 2025. GlobalData. 2016.

5. Provencio M, et al. Inoperable Stage III Non-Small Cell Lung Cancer: Current Treatment And Role Of Vinorelbine. J Thorac Dis. 2011;3:197-204.

6. Curran WJ, et al. Sequential vs Concurrent Chemoradiation for Stage III Non–Small Cell Lung Cancer: Randomized Phase III Trial RTOG 9410. J Natl Cancer Inst. 2011;103(19):1452-1460.

7. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) – Non-Small Cell Lung Cancer. Version 8. 2017. https://www.nccn.org/professionals/physician_gls/pdf/nscl_blocks.pdf. Accessed September 2020.

8. Hanna N, et al. Current Standards and Clinical Trials in Systemic Therapy for Stage III Lung Cancer: What is New? Am Soc Clin Oncol Educ Book. 2015:e442-447.

9. Kalemkerian GP, et al. Treatment Options for Relapsed Small-Cell Lung Cancer: What Progress Have We Made? J Oncol Pract. 2018;14(6):369-370.

10. National Cancer Institute. NCI Dictionary – Small Cell Lung Cancer. Available at https://www.cancer.gov/publications/dictionaries/cancer-terms/def/small-cell-lung-cancer. Accessed November 2020.

11. Cancer.Net. Lung Cancer – Small Cell. Available at https://www.cancer.net/cancer-types/lung-cancer-small-cell. Accessed November 2020.

12. ASCO. Cancer.net. Bladder Cancer. Available at: https://www.cancer.net/cancer-types/bladder-cancer/statistics. Accessed August 2020.

13. Von der Maase H, et al. Long-Term Survival Results of a Randomized Trial Comparing Gemcitabine Plus Cisplatin, with Methotrexate, Vinblastine, Doxorubicin, Plus Cisplatin in Patients with Bladder Cancer. J Clin Oncol. 2005;23:4602-4608.

14. American Society of Clinical Oncology. Bladder Cancer: Introduction. Available at https://www.cancer.net/cancer-types/bladder-cancer/introduction. Accessed September 2020.

15. American Society of Clinical Oncology. Bladder Cancer: Introduction. Available at https://www.cancer.net/cancer-types/bladder-cancer/introduction. Accessed August 2020.

16. Magdalene J, et al. Immune Responses in Bladder Cancer-Role of Immune Cell Populations, Prognostic Factors and Therapeutic Implications. Front Oncol. 2019;9:1270.

17. Pakkala, S, et al. Personalized Therapy for Lung Cancer: Striking a Moving Target. JCI Insight. 2018;3(15):e120858.

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Posted on November 20, 2020 7:03 am
Destination XL Group, Inc. Reports Third Quarter Financial Results

CANTON, Mass., Nov. 20, 2020 (GLOBE NEWSWIRE) — Destination XL Group, Inc. (NASDAQ: DXLG), the largest omni-channel specialty retailer of big and tall men’s clothing, today reported operating results for the third quarter of fiscal 2020 and provided a business update with respect to the COVID-19 pandemic.

Third Quarter Financial Highlights

Total sales for the third quarter were $85.2 million, down 20.1% from $106.6 million in the prior-year third quarter.

Cash Flow from operations for the first nine months of ($8.6) million as compared to the prior year of $(14.4) million. Free Cash Flow was ($11.6) million as compared to ($25.4) million last year.

Net loss for the third quarter was $(7.0) million as compared to a net loss of $(7.2) million in the prior year’s third quarter.

Adjusted EBITDA for the third quarter was $(1.7) million compared to $1.7 million in the prior-year quarter.

At October 31, 2020, cash balance of $21.4 million, total debt of $82.9 million and remaining availability under our credit facility of $13.5 million.

Management’s Comments

“For the past eight months we’ve been pivoting to position DXL for the long-term recovery from COVID-19 and future growth. In the third quarter, comparable sales which were down 20.5% improved from the second quarter, when our comparable sales were down 38.6%. Our store performance has improved each month from June through September with improvements in both traffic and conversion. In Direct, DXL.com was up 28.4%, with total Direct up 18.2% and total Direct penetration at 33.4%,” said Harvey Kanter, President and Chief Executive Officer.

“Despite the unrelenting impact of COVID-19 on the apparel industry, we believe our actions give DXL the strongest opportunity to succeed. Our digital transformation efforts, begun in mid-2019, have measurably impacted our ability to serve our core consumer in this volatile environment and provides us with even greater opportunity to navigate changes in consumer behavior. The fact that so many of us are staying close to home and avoiding large social gatherings has resulted in a solid improvement in many of our core and basic categories. Our customers still need to replenish basics and, in time, we know he will also need to update his wardrobe. We expect our business will continue to be challenged until we are able to start gathering socially in larger groups again and we see an increase in demand for event-based shopping visits, but we have cautious optimism for continued improvement.”

Kanter continued, “We recently completed our second corporate restructuring in the past 9 months to provide the Company with more financial flexibility. Together, the two restructurings have reduced our corporate workforce by 29% and our store workforce by 54% since the beginning of the year. We have also eliminated professional services and certain marketing costs to further right-size our cost structure. Our ability to restructure has been critical as it creates operating leverage and allows us to better withstand a decline in revenue. Reducing our cost structure and preserving our liquidity have been of paramount importance to our long-term recovery.

“From a liquidity perspective, we had a cash balance of $21.4 million and total debt of $82.9 million at the end of the third quarter. Total debt, net of cash, improved to $61.5 million compared to $77.5 million in the third quarter last year. Our focus on cash is relentless. With the significant steps we have taken to align our SG&A costs, we are now turning our attention to our landlord community in an attempt to right-size our lease structure. We have a cash management plan and we believe that we have sufficient liquidity to navigate our working capital needs for the next 12 months without additional financing and assuming no further significant shutdowns of the economy,” Mr. Kanter concluded.

Third Quarter Results

Sales

Total sales for the third quarter of fiscal 2020 decreased 20.1% to $85.2 million from $106.6 million in the third quarter of fiscal 2019. Comparable sales for the quarter were down 20.5% to last year. The 20.5% decrease in comparable sales was primarily driven by our stores, which were down 31.5% from the prior year’s third quarter, partially offset by our direct business, which was up 18.2%. The increase in our direct business was principally due to our DXL.com e-commerce site, which had a sales increase of 28.4%.

All of our stores had reopened by the end of June, and we were seeing month-over-month improvements in both traffic and conversion through September. However, with the resurgence of the virus, fires on the west coast and distractions from the election, our sales momentum slowed in October.

Our wholesale business contributed $5.0 million in sales during the third quarter, as compared to $2.9 million in the prior year, principally due to Amazon Essentials. We saw demand for masks, which was significant for us in the second quarter, drop during the third quarter.

Gross Margin

For the third quarter of fiscal 2020, our gross margin rate, inclusive of occupancy costs, was 36.5% as compared to a gross margin rate of 41.1% for the third quarter of fiscal 2019. Our gross margin rate declined 4.6% from a decrease of 2.8% in merchandise margins and a decrease of 1.8% due to the deleveraging in occupancy costs. Merchandise margins have improved from the second quarter of fiscal 2020, when merchandise margins were down 11.1% as we were highly promotional. During the third quarter, we made progress with improving our markdowns by focusing on more targeted promotions with a greater gross margin impact as well as improving on our clearance markdowns. Because of the growth in our direct channel and free shipping promotions, shipping costs continued to increase over the prior year and are expected to remain elevated in the fourth quarter.

Selling, General & Administrative

As a percentage of sales, SG&A (selling, general and administrative) expenses for the third quarter of fiscal 2020 were 38.5% as compared to 39.5% for the third quarter of fiscal 2019. On a dollar basis, SG&A decreased by $9.3 million, or 22.1%, as compared to the third quarter of fiscal 2019. We continue to take proactive measures to reduce our operating costs given the lower sales base. The decrease in the third quarter was primarily driven by a decrease in store and corporate payroll and cost reduction efforts throughout all areas of our business.

Subsequent to the end of the third quarter on November 2, 2020, we implemented an additional corporate restructuring to realign our SG&A costs with our sales levels. The restructuring included the termination of certain service agreements, the elimination of certain professional services and the elimination of an additional 45 positions in the corporate workforce. These additional actions are expected to result in annualized savings of approximately $9.7 million. This year, we have reduced our field organization by approximately 54% and our corporate workforce by 29%. With the reduced sales levels and store traffic, our stores are operating at minimal staffing levels and reduced operating hours. The Company expects to incur an aggregate charge of approximately $0.5 million in the fourth quarter of fiscal 2020 related to employee severance and one-time termination benefits.

Management views SG&A expenses through two primary cost centers: Customer Facing Costs and Corporate Support Costs. Customer Facing Costs, which include store payroll, marketing and other store operating costs, represented 19.2% of sales in the third quarter of fiscal 2020 as compared to 22.0% of sales in the third quarter of last year. Corporate Support Costs, which include the distribution center and corporate overhead costs, represented 19.3% of sales in the third quarter of fiscal 2020 compared to 17.5% of sales in the third quarter of last year.

Impairment of Assets

During the third quarter of fiscal 2020, the Company recorded a $1.2 million non-cash gain on the reduction of its operating lease liability in connection with its decision to close certain retail stores, which resulted in a revaluation of the lease liability. Approximately $1.1 million of this non-cash gain, related to leases where the right-of-use assets had previously been impaired, has been recorded as a reduction of the previously recorded impairment and is included in the Impairment of Assets line of the Consolidated Statement of Operations for the three and nine months ended October 31, 2020. The remaining gain of $0.1 million is included as a reduction in store occupancy costs and is reflected in the Cost of Goods Sold, Including Occupancy Costs on the Consolidated Statement of Operations for the three and nine months ended October 31, 2020.

Net Loss

For the third quarter of fiscal 2020, we had a net loss of $(7.0) million, or $(0.14) per diluted share, compared with a net loss of $(7.2) million, or $(0.14) per diluted share, for the third quarter of fiscal 2019.

On a non-GAAP basis, adjusting for a normalized tax rate of 26% for both periods, the adjusted net loss for the third quarter of fiscal 2020 was ($0.12) per diluted share, as compared to an adjusted net loss of ($0.08) per diluted share for the third quarter of fiscal 2019.

Adjusted EBITDA

Adjusted earnings before interest, taxes, depreciation and amortization (Adjusted EBITDA), a non-GAAP measure, for the third quarter of fiscal 2020 were $(1.7) million, compared to $1.7 million for the third quarter of fiscal 2019.

Cash Flow

Cash flow from operations for the first nine months of fiscal 2020 was $(8.6) million as compared to $(14.4) million for the first nine months of fiscal 2019 and free cash flow was $(11.6) million for the first nine months of fiscal 2020 as compared to $(25.4) million for the first nine months of fiscal 2019.

Continuing to manage and preserve liquidity has been a primary financial goal this quarter. We have eliminated costs where possible and have reduced the majority of our capital spending, except such spending necessary to our immediate business needs. Our capital expenditures for the first nine months of fiscal 2020 were $2.9 million as compared to $11.0 million for the same period last year.

For the nine months ended

(in millions) October 31, 2020 November 2, 2019

Cash flow from operating activities (GAAP basis) $ (8.6 ) $ (14.4 )

Capital expenditures, infrastructure projects (2.0 ) (7.2 )

Capital expenditures for DXL stores (0.9 ) (3.8 )

Free Cash Flow (non-GAAP basis) $ (11.6 ) $ (25.4 )

Non-GAAP Measures

Adjusted EBITDA, adjusted net loss, adjusted net loss per diluted share and free cash flow are non-GAAP financial measures. Please see “Non-GAAP Measures” below and reconciliations of these non-GAAP measures to the comparable GAAP measures that follow in the tables below.

Balance Sheet & Liquidity

Managing our liquidity and maintaining our financial flexibility continues to be our primary goal as we navigate through this pandemic. To this end, we have taken several actions since March, including but not limited to: (i) amending our credit facility to increase our borrowing base, (ii) decreasing our payroll and operating costs to align with the expected decrease in revenues, (iii) working with our landlords on short-term rent relief, (iv) cancellation of purchase orders, and (v) negotiating extended payment terms with our merchandise vendors.

At the end of the third quarter of fiscal 2020, we had a cash balance of $21.4 million, total debt (which consists of our revolving credit facility and long-term FILO loan) of $82.9 million and remaining availability under our credit facility of $13.5 million. Our availability under our credit facility is based on inventory levels, which are intentionally lower given the current sales environment. Total debt less cash for the third quarter is $61.5 million compared to $77.5 million in the third quarter of fiscal 2019.

Our accounts payable balance at the end of the third quarter of fiscal 2020 was $28.6 million as compared to $27.0 million at the end of the third quarter of fiscal 2019. Included in the October 31, 2020, balance are $1.3 million of promissory notes, payable through April 1, 2021. We continue to work with our vendors to secure extended payment terms where possible to better manage our working capital.

As of October 31, 2020, our inventory decreased approximately $25.3 million to $94.9 million, as compared to $120.2 million at November 2, 2019. We are managing our inventory conservatively, slowing replenishment and reducing fall receipts to align with the current sales trend. Our objective is to maintain a healthy inventory, which will include narrowing our assortment while also continuing to manage clearance levels. At October 31, 2020, our clearance inventory decreased by approximately $0.8 million, representing 11.8% of our total inventory, as compared to 10.0% at November 2, 2019.

Retail Store Information

Total retail square footage has steadily decreased since the end of fiscal 2017:

Year End 2017 Year End 2018 Year End 2019 At October 31, 2020

# of
Stores Sq Ft.
(000’s) # of
Stores Sq Ft.
(000’s) # of
Stores Sq Ft.
(000’s) # of
Stores Sq Ft.
(000’s)

DXL retail 212 1,665 216 1,684 228 1,729 227 1,724

DXL outlets 14 72 15 78 17 82 17 82

CMXL retail 78 268 66 221 50 164 49 160

CMXL outlets 33 103 30 91 28 85 23 69

Rochester Clothing 5 51 5 51 – – – –

Total 342 2,159 332 2,125 323 2,060 316 2,035

Of the 316 stores in our portfolio as of October 31, 2020, 52 stores are controlled by lease agreements that have a natural expiration or kick-out option by the end of fiscal 2021; 44 stores are controlled by lease agreements that have a natural expiration or kick-out option in fiscal 2022; and 220 stores are controlled by lease agreements that have a natural expiration or kick-out option in fiscal 2023 or later. We review store leases on a case-by-case basis and will make decisions to renew or terminate leases based on specific store performance and their overall strategic importance to the brand.

E-Commerce Information

The Company distributes its licensed branded and private label products directly to consumers through its stores, website and third-party marketplaces. E-commerce sales, which we also refer to as direct sales, are defined as sales that originate online, whether through our website, at the store level or through a third-party marketplace. For the third quarter of fiscal 2020, our direct sales increased by $4.1 million to 33.4% of retail segment sales as compared to 21.9% for the third quarter of fiscal 2019. The increase in sales growth and penetration was driven by a 28.4% increase in sales on our own website at DXL.com. Store traffic during the third quarter of fiscal 2020 has been slow to rebound and with the resurgence of the virus in much of the country, store traffic may continue to be down. As a result, we continue to see our e-commerce business playing a vital role in enabling us to continue to engage with our customers. Our direct business will be a critical component of how we navigate through the remainder of fiscal 2020 and beyond.

Conference Call

The Company will hold a conference call to review its financial results today, November 20, 2020 at 9:00 a.m. ET. To listen to the live webcast, visit the “Investor Relations” section of the Company’s website. The live call also can be accessed by dialing: (866) 680-2311. Please reference conference ID: 1282108. An archived version of the webcast may be accessed by visiting the “Events” section of the Company’s website for up to one year.

During the conference call, the Company may discuss and answer questions concerning business and financial developments and trends. The Company’s responses to questions, as well as other matters discussed during the conference call, may contain or constitute information that has not been disclosed previously.

Non-GAAP Measures

In addition to financial measures prepared in accordance with U.S. generally accepted accounting principles (“GAAP”), this press release contains non-GAAP financial measures, including adjusted EBITDA, adjusted net loss, adjusted net loss per diluted share and free cash flow. The presentation of these non-GAAP measures is not in accordance with GAAP, and should not be considered superior to or as a substitute for net loss, net loss per diluted share or cash flows from operating activities or any other measure of performance derived in accordance with GAAP. In addition, not all companies calculate non-GAAP financial measures in the same manner and, accordingly, the non-GAAP measures presented in this release may not be comparable to similar measures used by other companies. The Company believes the inclusion of these non-GAAP measures help investors gain a better understanding of the Company’s performance, especially when comparing such results to previous periods, and that they are useful as an additional means for investors to evaluate the Company’s operating results, when reviewed in conjunction with the Company’s GAAP financial statements. Reconciliations of these non-GAAP measures to their comparable GAAP measures are provided in the tables below.

The Company believes that adjusted EBITDA (calculated as earnings before interest, taxes, depreciation and amortization and excluding CEO transition costs, exit costs associated with London operations and asset impairment charges, if applicable) is useful to investors in evaluating its performance and is a key metric to measure profitability and economic productivity.

The Company has fully reserved against its deferred tax assets and, therefore, its net loss is not reflective of earnings assuming a “normal” tax position. In addition, we have added back charges for costs associated with the CEO transition, exit costs associated with London operations and asset impairment charges, if applicable, because it provides comparability of results without these charges. Adjusted net loss provides investors with a useful indication of the financial performance of the business, on a comparative basis, assuming a normalized effective tax rate of 26%.

Free cash flow is a metric that management uses to monitor liquidity. Management believes this metric is important to investors because it demonstrates the Company’s ability to strengthen liquidity while supporting its capital projects and new store growth. Free cash flow is calculated as cash flow from operating activities, less capital expenditures and excludes the mandatory and discretionary repayment of debt.

About Destination XL Group, Inc.

Destination XL Group, Inc. is the largest retailer of men’s clothing in sizes XL and up, with operations throughout the United States as well as in Toronto, Canada. In addition to DXL Big + Tall retail and outlet stores, subsidiaries of Destination XL Group, Inc. also operate Casual Male XL retail and outlet stores, and e-commerce sites, including DXL.com. DXL.com offers a multi-channel solution similar to the DXL store experience with the most extensive selection of online products available anywhere for Big + Tall men. The Company is headquartered in Canton, Massachusetts, and its common stock is listed on the NASDAQ Capital Market under the symbol “DXLG.” For more information, please visit the Company’s investor relations website: https://investor.dxl.com.

Forward-Looking Statements

Certain statements and information contained in this press release constitute forward-looking statements under the federal securities laws, including statements regarding the Company’s ability to withstand the impact of the COVID-19 pandemic on our business and results in fiscal 2020 and to manage through the pandemic, our efforts to restructure and reduce costs and, right size our lease structure, expected inventory levels for the remainder of fiscal 2020, the impact of direct sales on results in fiscal 2020, expected annualized savings from additional restructuring actions taken in November 2020, the ability to keep some or all of our reopened stores open and operating during more normalized hours, and our expected liquidity for the next 12 months. The discussion of forward-looking information requires management of the Company to make certain estimates and assumptions regarding the Company’s strategic direction and the effect of such plans on the Company’s financial results. The Company’s actual results and the implementation of its plans and operations may differ materially from forward-looking statements made by the Company. The Company encourages readers of forward-looking information concerning the Company to refer to its filings with the Securities and Exchange Commission, including without limitation, its Annual Report on Form 10-K filed on March 19, 2020, its Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission that set forth certain risks and uncertainties that may have an impact on future results and direction of the Company, including risks relating to the COVID-19 pandemic and its impact on the Company’s results of operations, the Company’s execution of its DXL strategy and ability to grow its market share, predict customer tastes and fashion trends, forecast sales growth trends and compete successfully in the United States men’s big and tall apparel market.

Forward-looking statements contained in this press release speak only as of the date of this release. Subsequent events or circumstances occurring after such date may render these statements incomplete or out of date. The Company undertakes no obligation and expressly disclaims any duty to update such statements.

Investor Contact:
ICR, Inc.
Tom Filandro, 646-277-1235
[email protected]

DESTINATION XL GROUP, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share data)

(unaudited)

For the three months ended For the nine months ended

October 31,
2020 November 2,
2019 October 31,
2020 November 2,
2019

Sales $ 85,171 $ 106,581 $ 218,840 $ 342,799

Cost of goods sold including occupancy 54,099 62,776 153,057 195,012

Gross profit 31,072 43,805 65,783 147,787

Expenses:

Selling, general and administrative 32,820 42,108 90,727 134,197

CEO transition costs — — — 702

Exit costs associated with London operations — 1,737 — 1,737

Impairment of assets (1,135 ) — 15,200 —

Depreciation and amortization 5,302 6,329 16,374 18,877

Total expenses 36,987 50,174 122,301 155,513

Operating loss (5,915 ) (6,369 ) (56,518 ) (7,726 )

Interest expense, net (1,080 ) (870 ) (2,873 ) (2,585 )

Loss before provision (benefit) for income taxes (6,995 ) (7,239 ) (59,391 ) (10,311 )

Provision (benefit) for income taxes 27 (49 ) 71 (78 )

Net loss $ (7,022 ) $ (7,190 ) $ (59,462 ) $ (10,233 )

Net loss per share – basic and diluted $ (0.14 ) $ (0.14 ) $ (1.16 ) $ (0.21 )

Weighted-average number of common shares outstanding:

Basic 51,545 50,089 51,127 49,853

Diluted 51,545 50,089 51,127 49,853

DESTINATION XL GROUP, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

October 31, 2020, February 1, 2020 and November 2, 2019

(In thousands)

(unaudited)

October 31, February 1, November 2,

2020 2020 2019

ASSETS

Cash and cash equivalents $ 21,417 $ 4,338 $ 5,462

Inventories 94,898 102,420 120,211

Other current assets 10,757 17,102 15,511

Property and equipment, net 60,617 78,279 83,371

Operating lease right-of-use assets 147,540 186,413 195,971

Intangible assets 1,150 1,150 1,150

Other assets 540 1,215 3,364

Total assets $ 336,919 $ 390,917 $ 425,040

LIABILITIES AND STOCKHOLDERS’ EQUITY

Accounts payable $ 28,580 $ 31,763 $ 27,038

Accrued expenses and other liabilities 27,886 23,390 24,905

Operating leases 196,522 223,227 233,374

Long-term debt 14,855 14,813 14,799

Borrowings under credit facility 68,019 39,301 68,185

Stockholders’ equity 1,057 58,423 56,739

Total liabilities and stockholders’ equity $ 336,919 $ 390,917 $ 425,040

CERTAIN COLUMNS IN THE FOLLOWING TABLES MAY NOT FOOT DUE TO ROUNDING

GAAP TO NON-GAAP RECONCILIATION OF ADJUSTED NET LOSS

AND ADJUSTED NET LOSS PER DILUTED SHARE

(unaudited)

For the three months ended For the nine months ended

October 31, 2020 November 2, 2019 October 31, 2020 November 2, 2019

$ Per diluted
share $ Per diluted
share $ Per diluted
share $ Per diluted
share

(in thousands, except per share data)

Net loss (GAAP basis) $ (7,022 ) $ (0.14 ) $ (7,190 ) $ (0.14 ) $ (59,462 ) $ (1.16 ) $ (10,233 ) $ (0.21 )

Adjust:

CEO transition costs – – – 702

Exit costs associated with London operations – 1,737 – 1,737

Impairment of assets (1,135 ) – 15,200 –

Add back actual income tax provision (benefit) 27 (49 ) 71 (78 )

Add income tax benefit, assuming a normal tax rate of 26% 2,114 1,431 11,490 2,047

Adjusted net loss (non-GAAP basis) $ (6,016 ) $ (0.12 ) $ (4,071 ) $ (0.08 ) $ (32,701 ) $ (0.64 ) $ (5,825 ) $ (0.12 )

Weighted average number of common shares

outstanding on a diluted basis 51,545 50,089 51,127 49,853

GAAP TO NON-GAAP RECONCILIATION OF ADJUSTED EBITDA

(unaudited)

For the three months ended For the nine months ended

October 31, 2020 November 2, 2019 October 31, 2020 November 2, 2019

(in millions)

Net loss (GAAP basis) $ (7.0 ) $ (7.2 ) $ (59.5 ) $ (10.2 )

Add back:

CEO transition costs – – – 0.7

Exit costs associated with London operations – 1.7 – 1.7

Impairment of assets (1.1 ) – 15.2 –

Provision (benefit) for income taxes – – 0.1 (0.1 )

Interest expense 1.1 0.9 2.9 2.6

Depreciation and amortization 5.3 6.3 16.4 18.9

Adjusted EBITDA (non-GAAP basis) $ (1.7 ) $ 1.7 $ (24.9 ) $ 13.6

GAAP TO NON-GAAP RECONCILIATION OF FREE CASH FLOW

(unaudited)

For the nine months ended

(in millions) October 31, 2020 November 2, 2019

Cash flow from operating activities (GAAP basis) $ (8.6 ) $ (14.4 )

Capital expenditures, infrastructure projects (2.0 ) (7.2 )

Capital expenditures for DXL stores (0.9 ) (3.8 )

Free Cash Flow (non-GAAP basis) $ (11.6 ) $ (25.4 )

Posted on November 20, 2020 7:03 am
BioCryst to Present at Upcoming Virtual Investment Conferences

RESEARCH TRIANGLE PARK, N.C., Nov. 20, 2020 (GLOBE NEWSWIRE) — BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced that the company will present at the Evercore ISI 3rd Annual HealthCONx on Wednesday, December 2, 2020 at 12:35 p.m. ET and at the Piper Sandler 32nd Annual Healthcare Conference. Both conferences are being conducted as virtual events.

Piper Sandler is pre-recording company presentations at the conference and the pre-recorded presentation may be accessed on Monday, November 23, 2020 in the Investors section of BioCryst’s website at http://www.biocryst.com.

Links to a live audio webcast and replay of the presentation at the Evercore ISI conference may be accessed on December 2, 2020 in the Investors section of BioCryst’s website at http://www.biocryst.com.

About BioCryst Pharmaceuticals

BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including ORLADEYO^™ (berotralstat), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB^® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst’s first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company’s website at www.BioCryst.com.

BCRXW

Contact:

John Bluth
+1 919 859 7910
[email protected]

Posted on November 20, 2020 7:03 am
BioRestorative Therapies Emerges from Chapter 11 Reorganization

MELVILLE, N.Y., Nov. 20, 2020 (GLOBE NEWSWIRE) — BioRestorative Therapies, Inc. (“BioRestorative” or the “Company”) (OTC: BRTX), a life sciences company focused on stem cell-based therapies, announced today that its amended joint plan of reorganization has become effective and it has emerged from Chapter 11 reorganization. Pursuant to the confirmed plan of reorganization, the Company has received $3,848,000 in financing. The confirmed plan of reorganization also provides for additional funding, subject to certain conditions, of $3,500,000 less the sum of the debtor-in-possession financing provided to the Company during the reorganization (approximately $1,227,000) and the costs incurred by the debtor-in-possession lender.

In connection with the reorganization, Lance Alstodt has been appointed the Company’s President, Chief Executive Officer and Chairman of the Board. Mr. Alstodt said, “This process has been a long and challenging journey for the Company. I’m inspired by the great resolve and execution from our employees, professionals and investors. We are very pleased that all requirements have been met for us to emerge. Allowed creditor claims have been fully satisfied and, as importantly, our equity holders have retained their shares in this exciting new opportunity. We were able to preserve all of our intellectual property assets and look forward to initiating our Phase 2 clinical trial.”

Based upon the Company’s emergence from Chapter 11 reorganization, FINRA has removed the “Q” at the end of its trading symbol. Shareholders do not need to exchange their shares for new shares.

About BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders:

• Disc/Spine Program (brtxDISC™): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person’s own) cultured mesenchymal stem cells collected from the patient’s bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders. The BRTX-100 production process utilizes proprietary technology and involves collecting a patient’s bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patient’s damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have received authorization from the Food and Drug Administration to commence a Phase 2 clinical trial using BRTX-100 to treat persistent lower back pain due to painful degenerative discs.

• Metabolic Program (ThermoStem®): We are developing a cell-based therapy to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (“BAT”). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in the body may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.

Forward-Looking Statements

This press release 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, as amended, and such forward-looking statements are made pursuant to the safe harbor provision
s of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in th
e forward-looking statements as a result of various factors and other risks, including, without limitation, those set forth in the Company’s latest Form 10-
K filed
with the Securities and Exchange Commission. You should consider these factors in evaluatin
g the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.

CONTACT:
Email: [email protected]

Posted on November 20, 2020 7:03 am
Trevena, Inc. Announces Publication Highlighting GI Tolerability Profile of OLINVYK™ (oliceridine) injection in Pain and Therapy

—

OLINVYK s
ignificantly reduced risk of vomiting and rescue antiemetic use
compared to IV morphine
in a retrospective analysis

—

CHESTERBROOK, Pa., Nov. 20, 2020 (GLOBE NEWSWIRE) — Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced a publication, titled “Oliceridine is Associated with Reduced Risk of Vomiting and Need for Rescue Antiemetics Compared to Morphine: Exploratory Analysis from Two Phase 3 Randomized Placebo and Active Controlled Trials,” with lead author Tim Beard, M.D., Chair of the Department of Surgery at Summit Medical Group (DOI: https://doi.org/10.1007/s40122-020-00216-x).

The results of this analysis highlight an improved gastrointestinal (GI) tolerability profile, with OLINVYK demonstrating a ~2-3x likelihood of achieving a “complete GI response” compared to IV morphine under equianalgesic conditions. A complete GI response is defined as the proportion of patients who complete the study without vomiting and without using any antiemetics.

“There are multiple types of procedures where post-operative nausea or vomiting can disrupt the integrity of a surgery, posing a significant challenge to a patient’s recovery,” said Tim Beard, M.D. “Based on the results of this analysis, OLINVYK has the potential to greatly reduce the risk of nausea and vomiting following surgery, compared to IV morphine. These are compelling findings that suggest the clinical advantages OLINVYK may offer in the post-operative acute care setting.”

Publication Key Points:

O

rthopedic

surgery-bunionectomy study

:
A higher proportion of patients achieved ‘complete GI response’ with all OLINVYK treatment regimens (0.1 mg: 76.3%; 0.35 mg: 53.2%; 0.5 mg: 49.4%) compared to IV morphine (32.9%; p < 0.05 for all 3 OLINVYK dose regimens).

P

lastic

surgery-abdominoplasty study

:
A higher proportion of patients achieved ‘complete GI response’ with all OLINVYK treatment regimens (0.1 mg: 59.7%; 0.35 mg: 39.2%; 0.5 mg: 29.9%) compared to IV morphine (28.8%; p ≤ 0.0001 for OLINVYK 0.1 mg).

P

ooled

data from

both

trials

:
There was a statistically significantly higher rate of ‘complete GI response’ associated with OLINVYK 0.1 mg (68%) and 0.35 mg (46.2%) compared to IV morphine (30.8%; p ≤ 0.005).

Under equianalgesic conditions
: Where analgesia as measured by Sum of Pain Intensity Difference (SPID) scores was held constant, patients were 3.1x more likely to achieve a ‘complete GI response’ with OLINVYK than IV morphine in the orthopedic surgery-bunionectomy study (95% CI: 1.78, 5.56; p <0.0001), and 1.9x more likely in the plastic-surgery abdominoplasty study (95% CI: 1.09, 3.36; p = 0.024).

About OLINVYK™ (oliceridine) injection

OLINVYK is a new chemical entity approved by the FDA in August 2020. OLINVYK contains oliceridine, a Schedule II controlled substance with a high potential for abuse similar to other opioids. It is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. OLINVYK is available in 1 mg/1 mL and 2 mg/2 mL single-dose vials, and a 30 mg/30 mL single-patient-use vial for patient-controlled analgesia (PCA). Approved PCA doses are 0.35 mg and 0.5 mg and single bolus doses greater than 3 mg have not been evaluated. The cumulative daily dose should not exceed 27 mg. Please see Important Safety Information, including the BOXED WARNING, and full prescribing information at www.OLINVYK.com.

About Trevena

Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has one approved product in the United States, OLINVYK™ (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company also has four novel and differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, and TRV027 for acute lung injury / abnormal blood clotting in COVID-19 patients. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

For more information, please visit www.Trevena.com

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates, commercialization of approved drug products and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “objective,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” “ongoing,” or the negative of these terms or similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the commercialization of any approved drug product, the status, timing, costs, results and interpretation of the Company’s clinical trials or any future trials of any of the Company’s investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company’s assessment of the discussions with the FDA or other regulatory agencies about any and all of its programs; uncertainties related to the commercialization of OLINVYK; available funding; uncertainties related to the Company’s intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company’s therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company’s views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

For more information, please contact:

Investor Contact:

Dan Ferry
Managing Director
LifeSci Advisors, LLC
[email protected]
(617) 430-7576

Company Contact:

Bob Yoder
SVP and Chief Business Officer
Trevena, Inc.
(610) 354-8840

Posted on November 20, 2020 7:03 am
Baudax Bio Announces Publication of ANJESO® Network Meta-Analysis in the Peer-Reviewed Journal BMC Anesthesiology

ANJESO Found to Provide Superior Pain Relief with Similar or Better Safety Compared to Other Approved IV Non-Opioid Analgesics

MALVERN, Pa., Nov. 20, 2020 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced the online publication of a Network Meta-Analysis (NMA) for ANJESO (meloxicam) injection in the peer-reviewed medical journal BMC Anesthesiology. ANJESO was recently launched in the U.S. and is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics.

“The management of post-operative pain remains a significant issue, including providing adequate pain control beyond immediate postsurgical recovery,” said Jonathan Jahr, M.D., Professor Emeritus, Anesthesiology, University of California, Los Angeles School of Medicine. “Based on the results of multiple clinical trials, ANJESO (meloxicam) injection has been found to provide relief of moderate to severe acute pain, alone or in combination with other analgesics within the first 15 minutes after dosing and up to 24 hours after dosing compared to placebo. Specifically, ANJESO (meloxicam) injection provided superior pain relief for abdominoplasty, bunionectomy and hysterectomy when compared with acetaminophen, ibuprofen, and ketorolac, while also demonstrating a compelling profile with respect to reducing morphine consumption. Notably, ANJESO (meloxicam) injection was significantly more effective at reducing pain intensity than all comparators for those procedures in which pain intensity scores were recorded.”

“We believe that ANJESO offers an effective, non-opioid therapeutic option for the management of postsurgical pain for eligible patients,” said Stewart McCallum, M.D., F.A.C.S., Chief Medical Officer of Baudax Bio. “As the only intravenous IV NSAID that lasts up to 24 hours, ANJESO has an equal or better safety profile than that of other IV non-opioids, and benefits patients by reducing their opioid consumption post-surgery. The results of this meta-analysis add to the growing body of data supporting our ongoing ANJESO commercial launch efforts.”

ANJESO
N
etwork
M
eta-
A
nalysis
Results

The published NMA results are based on the screening of over 2,300 studies, whereby 27 studies were identified and included in the analysis. Randomized clinical trials from 2000 to 2019 which involved at least one of the following procedures: open abdominal surgery, bunionectomy, open hysterectomy, orthopedic joint replacement surgery (including knee, ankle, hip, shoulder) were evaluated for inclusion. The literature search included publications that reported clinical effectiveness, safety and tolerability in adult patients receiving post-operative pain treatments. For this NMA, ANJESO was indirectly compared with only those IV treatments that were available at the time in the U.S., including acetaminophen, ibuprofen, and ketorolac. Studies for other non-opioid analgesics such as parecoxib and diclofenac were used for indirect comparison with the placebo arms in those studies.

The NMA found that among patients reporting moderate to severe postoperative pain, ANJESO was superior in pain reduction for abdominoplasty, bunionectomy and hysterectomy when compared with acetaminophen, ibuprofen, and ketorolac. In reducing morphine consumption, ANJESO was associated with significantly less morphine milligram equivalents (MME) utilization versus all comparators for abdominal procedures, hysterectomy, and versus acetaminophen in orthopedic procedures. Elsewhere MME utilization outcomes for ANJESO were largely equivalent or nominally better than other comparators.

The odds of opioid-related adverse events (ORADEs) were significantly higher for all comparators compared to ANJESO for orthopedic (gastrointestinal) and hysterectomy (respiratory). These results suggest ANJESO may provide better pain relief with a similar or better reduction in ORADEs compared to other approved IV NSAIDS.

About ANJESO®

ANJESO (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis. ANJESO was launched in the U.S. in June 2020 following its approval by the Food and Drug Administration in February 2020. ANJESO is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. Because of the delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required. ANJESO is supported by two pivotal Phase III clinical efficacy trials, a large double-blind, placebo-controlled Phase III safety trial and four Phase II clinical efficacy trials, as well as other safety studies. As a non-opioid, Baudax Bio believes ANJESO has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential, while maintaining meaningful analgesic effects for relief of pain. ANJESO was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

About Baudax Bio

Baudax Bio is a pharmaceutical company focused on therapeutics for acute care settings. The launch of Baudax Bio’s first commercial product ANJESO® began in June 2020 following its approval by the U.S. Food and Drug Administration in February 2020. ANJESO is a once daily IV NSAID with preferential COX-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. In addition to ANJESO, Baudax has a pipeline of other pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies, and intranasal dexmedetomidine which is being developed for possible uses in pain or sedation. For more information please visit www.baudaxbio.com.

Cautionary Statement Regarding Forward Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “may,” “upcoming,” “plan,” “target,” “goal,” “intend,” and “expect,” and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio’s performance to differ materially from those expressed in, or implied by, these forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO® or disruption in supply chain, Baudax Bio’s ability to maintain regulatory approval for ANJESO, Baudax Bio’s ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bio’s ability and that of Baudax Bio’s third party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO, Baudax Bio’s ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio’s ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bio’s ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio’s ability to comply with the financial and other covenants under its credit facility, Baudax Bio’s ability to manage costs and execute on our operational and budget plans, the accuracy of Baudax Bio’s estimates of the potential market for ANJESO, Baudax Bio’s ability to achieve its financial goals; and Baudax Bio’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law.

CONTACT:

Investor Relations Contact:
Argot Partners
Sam Martin / Claudia Styslinger
(212) 600-1902
[email protected]
[email protected]

Baudax Bio, Inc.
Ryan D. Lake
(484) 395-2436
[email protected]

Media Contact:
Argot Partners
David Rosen
(212) 600-1902
[email protected]

Posted on November 20, 2020 7:03 am
AAON Named a Mosaic Top Inclusive Workplace

TULSA, Okla., Nov. 20, 2020 (GLOBE NEWSWIRE) — AAON, Inc. (NASDAQ: AAON), a leading manufacturer of heating and cooling products, announced that it has been named a 2020 Top Inclusive Workplace by Mosaic and the Tulsa Regional Chamber. Mosaic is the Tulsa Regional Chamber-led coalition of companies and nonprofit partners that celebrate diversity, champion equity and cultivate inclusion within the region’s business community. In order to qualify as a Top Inclusive Workplace, a company or organization must complete the Mosaic Index and report in the areas of CEO commitment, diverse suppliers, diverse people, internal policy and community outreach.

“AAON is honored to be named as a Top Inclusive Workplace in recognition of our commitment to diversity, equity and inclusion,” said Gary Fields, President and CEO of AAON. “We know that diversity and inclusion are key drivers for furthering innovation, productivity and team member engagement at AAON.”

AAON has two team member resource groups: AAON Veterans Empowering Through Service (V.E.T.S.) and the Women’s Alliance and Resource Program (WARP). AAON employs individuals from over 32 countries, and has a focus on promoting from within. On-site classes are available to help team members develop professionally and advance in the company such as: English as a Second Language, Spanish Language Classes, and Frontline Leadership Training for new and existing leaders.

About Mosaic

Mosaic is the Tulsa Regional Chamber-led coalition of companies and nonprofit partners that celebrate diversity, champion equity and cultivate inclusion within the region’s business community. Mosaic seeks to leverage the region’s diversity to improve perceptions of our community and grow the economy. Ultimately, Mosaic wishes to catapult the Tulsa region into the forefront of diversity and inclusion through talent recruitment initiatives and business retention and expansion efforts.

About AAON

AAON is engaged in the engineering, manufacturing, marketing, and sale of air conditioning and heating equipment consisting of standard, semi-custom, and custom rooftop units, chillers, packaged outdoor mechanical rooms, air handling units, condensing units, makeup air units, energy recovery units, geothermal/water-source heat pumps, coils, and controls. Since the founding of AAON in 1988, AAON has maintained a commitment to design, develop, manufacture and deliver heating and cooling products to perform beyond all expectations and demonstrate the value of AAON to our customers. For more information, please visit www.AAON.com.

Contact:
Stephanie Cameron
AAON, Inc.
918-688-9796
[email protected]

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