Le Lézard
Classified in: Health, Science and technology, Business, Covid-19 virus
Subjects: EARNINGS, Conference Call, Webcast

Omeros Corporation Reports Second Quarter 2022 Financial Results


Omeros Corporation (Nasdaq: OMER), a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation and immunologic diseases, including complement-mediated diseases and cancers, today announced recent highlights and developments as well as financial results for the second quarter ended June 30, 2022, which include:

"We remain confident that approval of narsoplimab in TA-TMA is warranted, and we look forward to OND's decision later this month," said Gregory A. Demopulos, M.D., Omeros' chairman and chief executive officer. "In addition to FDA's decision on narsoplimab approval, a series of value-driving milestones have aligned over the next few quarters: data from our Phase 3 trial of narsoplimab in IgA nephropathy are on track for readout by mid-next year; our MASP-3 inhibitor OMS906 is starting trials in PNH and C3 glomerulopathy with efficacy data targeted by early next year; about that same time, we expect data from our Phase 1 trial of OMS1029, our long-acting MASP-2 inhibitor, which began dosing earlier this week; also in early 2023, our PDE7 inhibitor OMS527 should have data available in a clinically predictive primate model of levodopa-induced dyskinesias; and, with separate payment for OMIDRIA reconfirmed by CMS in its recently released proposed rule for the Outpatient Prospective Payment System, we expect continuing growth in our royalty stream and, should OMIDRIA obtain long-term reimbursement, to secure the $200-million milestone payment."

Second Quarter and Recent Clinical Developments

Recent developments regarding OMS906, Omeros' lead monoclonal antibody targeting MASP-3, the key activator of the alternative pathway, and OMS1029, the company's long-acting, next-generation MASP-2 inhibitor, include the following:

Financial Results

On December 23, 2021, Rayner acquired OMIDRIA and certain related assets and liabilities. The completion of the sale required Omeros to reclassify all revenues and expenses related to OMIDRIA as discontinued operations for fiscal year 2021 in its financial statements.

During the second quarter of 2022, Omeros earned royalties of $17.2 million on sales of OMIDRIA, which were recorded as a reduction from the OMIDRIA contract royalty asset. The company also recorded $10.1 million of income in discontinued operations, primarily representing interest income and remeasurement adjustments to the OMIDRIA contract royalty asset.

Total costs and expenses for the second quarter of 2022 were $37.4 million compared to $45.6 million for the second quarter of 2021. The decrease was primarily due to the timing of narsoplimab manufacturing activities and a reduction in U.S. TA-TMA pre-launch activities.

Net loss was $30.9 million in the second quarter of 2022, or $0.49 per share, which included $3.7 million of non-cash expenses, or $0.06 per share. This compares to a net loss of $28.6 million, or $0.46 per share, including $3.9 million of non-cash expenses, or $0.06 per share, in 2Q 2021.

As of June 30, 2022, the company had $122.2 million of cash, cash equivalents and short-term investments with an additional $14.5 million in receivables, net.

Conference Call Details

To access the live conference call via phone, please dial (833) 634-2592 from the United States and Canada or (412) 902-4100 internationally and ask to be placed into the Omeros earnings call. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week following the call and may be accessed by dialing (877) 344-7529 from the United States, (412) 317-0088 internationally, and (855) 669-9658 from Canada. The replay access code is 4990130.

For online access to the live or subsequently archived webcast of the conference call, go to Omeros' website at https://investor.omeros.com/upcoming-events.

About Omeros Corporation

Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders including complement-mediated diseases, cancers, and addictive and compulsive disorders. Omeros' lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application pending before FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, COVID-19, and atypical hemolytic uremic syndrome. OMS906, Omeros' inhibitor of MASP-3, the key activator of the alternative pathway of complement, is advancing in clinical programs for paroxysmal nocturnal hemoglobinuria (PNH), complement 3 (C3) glomerulopathy and one or more related indications. For more information about Omeros and its programs, visit www.omeros.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the "safe harbor" created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as "anticipate," "believe," "could," "estimate," "expect," "goal," "intend," "likely," "look forward to," "may," "objective," "plan," "potential," "predict," "project," "should," "slate," "target," "will," "would" and similar expressions and variations thereof. Forward-looking statements, including expectations with regard to Omeros' pursuit of regulatory approval for narsoplimab in TA-TMA, including expectations regarding the potential or anticipated outcomes of its formal dispute resolution request, and expectations regarding the initiation or continuation of clinical trials evaluating Omeros' drug candidates and the anticipated availability of data therefrom, and expectations regarding growth in royalty-generating sales, are based on management's beliefs and assumptions and on information available to management only as of the date of this press release. Omeros' actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, unanticipated or unexpected outcomes of regulatory processes in relevant jurisdictions, unproven preclinical and clinical development activities, the impact of COVID-19 on our business, financial condition and results of operations, regulatory processes and oversight, challenges associated with manufacture or supply of our investigational or clinical products, changes in reimbursement and payment policies by government and commercial payers or the application of such policies, intellectual property claims, competitive developments, litigation, and the risks, uncertainties and other factors described under the heading "Risk Factors" in the company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 1, 2022. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the company assumes no obligation to update these forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

OMEROS CORPORATION

UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except share and per share data)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Six Months Ended

 

 

June 30,

 

June 30,

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

23,516

 

 

$

30,126

 

 

$

47,603

 

 

$

62,630

 

Selling, general and administrative

 

 

13,922

 

 

 

15,484

 

 

 

24,881

 

 

 

28,270

 

Total costs and expenses

 

 

37,438

 

 

 

45,610

 

 

 

72,484

 

 

 

90,900

 

Loss from continuing operations

 

 

(37,438

)

 

 

(45,610

)

 

 

(72,484

)

 

 

(90,900

)

Interest expense

 

 

(4,927

)

 

 

(4,910

)

 

 

(9,868

)

 

 

(9,807

)

Other income

 

 

670

 

 

 

333

 

 

 

1,163

 

 

 

751

 

Net loss from continuing operations

 

 

(41,695

)

 

 

(50,187

)

 

 

(81,189

)

 

 

(99,956

)

Net income from discontinued operations

 

 

10,846

 

 

 

21,594

 

 

 

17,329

 

 

 

36,273

 

Net loss

 

$

(30,849

)

 

$

(28,593

)

 

$

(63,860

)

 

$

(63,683

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted net income (loss) per share

 

 

 

 

 

 

 

 

 

 

 

 

Net loss from continuing operations

 

 

(0.66

)

 

 

(0.80

)

 

$

(1.30

)

 

$

(1.61

)

Net income from discontinued operations

 

 

0.17

 

 

 

0.34

 

 

 

0.28

 

 

 

0.59

 

Net loss

 

$

(0.49

)

 

$

(0.46

)

 

$

(1.02

)

 

$

(1.02

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted-average shares used to compute basic and diluted net income (loss) per share

 

 

62,730,015

 

 

 

62,373,521

 

 

 

62,727,395

 

 

 

62,154,714

 

(1)

The sale of OMIDRIA has been accounted for as the sale of an asset. Accordingly, we have reclassified all revenues and expenses related to OMIDRIA to net income from discontinued operations for the three and six months ended June 30, 2021 in our financial statements.

OMEROS CORPORATION

UNAUDITED CONSOLIDATED BALANCE SHEET DATA

(In thousands)

 

 

 

 

 

 

 

 

 

June 30,

 

December 31,

 

 

2022

 

 

2021

Cash and cash equivalents

 

$

122,562

 

 

$

157,266

OMIDRIA contract royalty asset

 

 

170,606

 

 

 

184,570

Total assets

 

345,638

 

 

419,268

Total current liabilities

 

 

38,501

 

 

 

51,789

Lease liabilities

 

 

28,665

 

 

 

34,381

Unsecured convertible senior notes, net

 

 

314,358

 

 

 

313,458

Total shareholders' equity (deficit)

 

 

(32,702

)

 

 

23,780

Working capital

 

154,221

 

 

196,167

OMEROS CORPORATION

UNAUDITED CONSOLIDATED SUPPLEMENTAL DATA

(In thousands)

 

The following schedule presents a rollforward of the OMIDRIA contract royalty asset:

 

 

 

 

OMIDRIA contract royalty asset at December 31, 2021

 

$

184,570

 

Royalties earned

 

 

(31,062

)

Royalty interest income and remeasurement adjustments

 

 

17,098

 

OMIDRIA contract royalty asset at June 30, 2022

 

$

170,606

Net income from discontinued operations is as follows:

 

 

Three Months Ended

 

Six Months Ended

 

 

June 30,

 

June 30,

 

 

2022

 

 

2021

 

2022

 

 

2021

 

 

(In thousands)

Product sales, net

 

$

?

 

 

$

28,823

 

$

?

 

 

$

49,884

Royalty interest income and remeasurement adjustments

 

 

10,102

 

 

 

?

 

 

17,098

 

 

 

?

Total

 

 

10,102

 

 

 

28,823

 

 

17,098

 

 

 

49,884

Other income, costs and expenses, net

 

 

(744

)

 

 

7,229

 

 

(231

)

 

 

13,611

Net income from discontinued operations

 

$

10,846

 

 

$

21,594

 

$

17,329

 

 

$

36,273

 


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