ImmuCell Announces Unaudited Financial Results for the Third Quarter Ended September 30, 2020

PORTLAND, Maine, Nov. 12, 2020 (GLOBE NEWSWIRE) — ImmuCell Corporation (Nasdaq: ICCC) (“ImmuCell” or the “Company”), a growing animal health company that develops, manufactures and markets scientifically-proven and practical products that improve the health and productivity of dairy and beef calves, today announced unaudited financial results for the quarter ended September 30, 2020.


Product Sales Results:

  • Total product sales increased by 25%, or $752,000, to $3.7 million during the three-month period ended September 30, 2020 versus the comparable period during 2019.
  • The backlog of orders was reduced to approximately $130,000 as of September 30, 2020 from approximately $945,000 as of June 30, 2020.
  • During the nine-month period ended September 30, 2020, total product sales increased by 15%, or $1.5 million, to $11.6 million versus the comparable period during 2019.
  • Total product sales increased by 17%, or $2.2 million, to $15.2 million during the trailing twelve-month period ended September 30, 2020 versus the trailing twelve-month period ended September 30, 2019.


Management


’s


Discussion:


“As indicated by the top line growth, our sales team continues to be productive and healthy despite COVID-19’s impact on the economy,” commented Michael F. Brigham, President and CEO. “We are making measurable progress in expanding our First Defense® business. We reduced the backlog of orders and expect to fully realize the benefits of our expanded production capacity beginning in the second quarter of 2021.”

“Our first production priority is Tri-Shield First Defense® because our growth is being driven primarily by this product format, which contributes the higher gross margin dollar but at a lower gross margin percentage of sales,” added Mr. Brigham. “As we increase colostrum collection from new cows that have not been immunized previously with our proprietary vaccines, our production yields tend to decline, but we expect that to improve over time. Tri-Shield® provides antibodies without vaccination so every calf receives a measured dose of Immediate Immunity™ against all three of the primary scour-causing pathogens, E. coli, coronavirus, and rotavirus.”

“Most of our product development expenses were related to the Re-Tain™ product development and commercial scale-up initiative,” concluded Mr. Brigham. “We are proceeding on plan to make our second-phased submission of the CMC Technical Section by the end of the year, which will be subject to at least one six-month review by the FDA.”


Other


Financial Results:

  • Gross margin earned was 46% and 49% of total product sales during the quarters ended September 30, 2020 and 2019, respectively.
  • Gross margin earned was 45% and 49% of total product sales during the nine-month periods ended September 30, 2020 and 2019, respectively.
  • Product development expenses were $1.1 million and $985,000 during the quarters ended September 30, 2020 and 2019, respectively.
  • Product development expenses were $3.2 million and $2.7 million during the nine-month periods ended September 30, 2020 and 2019, respectively.
  • Net loss was $323,000, or $0.04 per share, during the quarter ended September 30, 2020 in comparison to net loss of $503,000, or $0.07 per share, during the quarter ended September 30, 2019.
  • Net loss was $1.2 million, or $0.17 per share, during the nine-month period ended September 30, 2020 in comparison to net loss of $985,000, or $0.15 per share, during the nine-month period ended September 30, 2019.
  • The $937,700 loan received under the Paycheck Protection Program was recorded as a liability as of September 30, 2020. Subsequent to then, we received notice from our bank that this loan has been fully forgiven by the federal government. The full amount is expected to be recognized as other income during the fourth quarter of 2020.
  • EBITDA (a non-GAAP financial measure defined on page 4 of this press release) was $354,000 and $179,000 during the quarters ended September 30, 2020 and 2019, respectively.
  • EBITDA was $1,008,000 and $1,085,000 during the nine-month periods ended September 30, 2020 and 2019, respectively.


B


alance Sheet Data as of


September


30


, 20


20


:

  • Cash, cash equivalents, short-term investments and restricted cash decreased to $7.3 million as of September 30, 2020 from $8.8 million as of December 31, 2019.
  • Net working capital decreased to $8.1 million as of September 30, 2020 from $10.7 million as of December 31, 2019.
  • Total assets increased to $40 million as of September 30, 2020 from $38.7 million as of December 31, 2019.
  • Stockholders’ equity decreased to $28 million as of September 30, 2020 from $29 million as of December 31, 2019.



C
ondensed Statements of Operations (Unaudited)

       
  During
the Three-Month

Periods
Ended
September
30
,
  During the
Nine
-Month

Periods Ended
September
30,
(In thousands, except per share amounts) 20
20
    201
9
    2020     2019  
               
Product sales $3,723     $2,970     $11,599     $10,091  
Costs of goods sold 2,001     1,519     6,357     5,189  
Gross margin 1,722     1,451     5,242     4,902  
               
Sales, marketing and administrative expenses 851     896     2,804     2,898  
Product development expenses 1,123     985     3,184     2,715  
Operating expenses 1,974     1,881     5,988     5,613  
               
NET OPERATING
LOSS
(252 )   (430 )   (746 )   (711 )
               
Other expenses, net 71     65     480     242  
               
LOSS
BEFORE INCOME TAXES
(323 )   (495 )   (1,226 )   (953 )
               
Income tax expense (benefit)     8     (15 )   32  
               
NET
LOSS
($323 )   ($503 )   ($1,211 )   ($985 )
               
Basic weighted average common shares outstanding 7,213     7,210     7,213     6,687  
Basic net loss per share ($0.04 )   ($0.07 )   ($0.17 )   ($0.15 )
               
Diluted weighted average common shares outstanding 7,213     7,210     7,213     6,687  
Diluted net loss per share ($0.04 )   ($0.07 )   ($0.17 )   ($0.15 )
               



Selected Balance Sheet Data (In thousands) (Unaudited)

       
  As of


September 30


, 20


20
  As of


December 31, 201


9
       
Cash, cash equivalents, short-term investments and restricted cash         $7,313   $8,774
Net working capital    8,135       10,694
Total assets 39,987      38,692
Stockholders’ equity $28,021   $28,991
       


Non-GAAP Measures:


Generally, a non-GAAP financial measure is a numerical measure of a company’s performance, financial position or cash flow that either excludes or includes amounts that are not normally excluded or included in the most directly comparable measure calculated and presented in accordance with GAAP. The non-GAAP measures included in this press release should be considered in addition to, and not as a substitute for or superior to, the comparable measure prepared in accordance with GAAP. A reader should review our Statements of Cash Flows for a detailed understanding of our sources and uses of cash. We start with our reported loss before income taxes because presently we are not paying cash for income taxes and do not anticipate paying significant cash for income taxes in the near-term future. We believe that considering the non-GAAP income before income taxes and before certain non-cash expenses assists management and investors by looking at our performance across reporting periods on a consistent basis excluding these certain charges that are not uses of cash from our reported loss before income taxes. We calculate non-GAAP income before income taxes and certain non-cash expenses as indicated in the table below:

  During
the Three-Month
Periods Ended

September
3
0
,
  During the
Nine
-Month

Periods Ended

September
30,
(In thousands) 20
20
    201
9
    20
20
    201
9
 
               
Loss before income taxes ($323 )   ($495 )   ($1,226 )   ($953 )
Depreciation, amortization and stock-based compensation 665     640     2,032     1,939  
Income before income taxes and certain non-cash expenses $342     $145     $806     $986  
                       

The figures we have calculated and reported above do not include cash used to repay bank debt in the amounts of $143,000 and $215,000 during the three-month periods ended September 30, 2020 and 2019, respectively, and $488,000 (exclusive of the $8.3 million used to repay our refinanced bank debt) and $644,000 during the nine-month periods ended September 30, 2020 and 2019, respectively. The figures calculated above differ from the calculation of Earnings Before Interest, Taxes, Depreciation and Amortization (EBITDA) in two significant ways. First, we have not added back interest expense because we do pay cash for interest. Interest expense was $76,000 and $107,000 during the quarters ended September 30, 2020 and 2019, respectively, and $500,000 and $333,000 during the nine-month periods ended September 30, 2020 and 2019, respectively. During the nine-month period ended September 30, 2020, interest expense included payments of $165,000 to terminate our interest rate swap agreements and $95,000 to write-off debt issuance costs, both made in connection with the refinancing of our bank debt during the first quarter of 2020. Second, we have added back stock-based compensation expense because this is a non-cash expense, but it is not added back to the calculation of EBITDA. EBITDA was $354,000 and $179,000 during the quarters ended September 30, 2020 and 2019, respectively, and $1,008,000 and $1,085,000 during the nine-month periods ended September 30, 2020 and 2019, respectively.


Conference Call:


Interested parties can access the conference call scheduled by the Company to review the full third quarter 2020 financial results by dialing (844) 855-9502 (toll free) or (412) 317-5499 (international) at 9:00 AM ET on Friday, November 13, 2020. A teleconference replay of the call will be available for seven days at (877) 344-7529 (toll free) or (412) 317-0088 (international), utilizing confirmation #10148680.

Investors are encouraged to review the Company’s Quarterly Report on Form 10-Q for the three-month period ended September 30, 2020 that was filed with the SEC on Thursday, November 12, 2020 and its updated Corporate Presentation slide deck that provides an overview of the Company’s business and is available under the “Investors” tab of the Company’s website at www.immucell.com, or by request to the Company.


About


ImmuCell


:


ImmuCell Corporation’s (Nasdaq: ICCC) purpose is to create scientifically-proven and practical products that improve the health and productivity of dairy and beef calves. ImmuCell manufactures and markets First Defense®, providing Immediate Immunity™ to newborn dairy and beef calves, and is in the late stages of developing Re-Tain, a novel treatment for subclinical mastitis without a milk discard requirement that provides an alternative to traditional antibiotics. Press releases and other information about the Company are available at: http://www.immucell.com.

Contacts:    Michael F. Brigham, President and CEO
  ImmuCell Corporation
  (207) 878-2770
   
  Joe Diaz, Robert Blum and Joe Dorame
  Lytham Partners, LLC
  (602) 889-9700
  [email protected] 
   


Cautionary Note Regarding Forward-Looking Statements (Safe


Harbor


Statement):

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. Such statements include, but are not limited to, any statements relating to: our plans and strategies for our business; projections of future financial or operational performance; the timing and outcome of pending or anticipated applications for regulatory approvals; factors that may affect the dairy and beef industries and future demand for our products; the extent, nature and duration of the COVID-19 pandemic and its consequences, and their direct and indirect impacts on the Company’s production activities, operating results and financial condition and on the customers and markets the Company serves; the scope and timing of ongoing and future product development work and commercialization of our products; future costs of product development efforts; the estimated prevalence rate of subclinical mastitis and producers’ level of interest in treating subclinical mastitis given the current economic and market conditions; the expected efficacy of new products; estimates about the market size for our products; future market share of and revenue generated by current products and products still in development; our ability to increase production output and reduce costs of goods sold associated with our new product, Tri-Shield First Defense®; the future adequacy of our own manufacturing facilities or those of third parties with which we have contractual relationships to meet demand for our products on a timely basis; the anticipated costs of (or time to complete) planned expansions of our manufacturing facilities and the adequacy of our funds available for these projects; the continuing availability to us on reasonable terms of third-party providers of critical products or services; the robustness of our manufacturing processes and related technical issues; estimates about our production capacity, efficiency and yield, which are highly subject to biological variability and the product format mix of our sales; the future adequacy of our working capital and the availability and cost of third-party financing; our ability to gain access to all or a substantial portion of the cash escrow funds presently held by our bank lender; future regulatory requirements relating to our products; future expense ratios and margins; future compliance with bank debt covenants; costs associated with sustaining compliance with current Good Manufacturing Practice (cGMP) regulations in our current operations and attaining such compliance for the facility to produce the Nisin Drug Substance; implementation of international trade tariffs that could reduce the export of dairy products, which could in turn weaken the price received by our customers for their products; our effectiveness in competing against competitors within both our existing and our anticipated product markets; the cost-effectiveness of additional sales and marketing expenditures and resources; anticipated changes in our manufacturing capabilities and efficiencies; the value of our net deferred tax assets; projections about depreciation expense and its impact on income for book and tax return purposes; anticipated market conditions; and any other statements that are not historical facts. Forward-looking statements can be identified by the use of words such as “expects”, “may”, “anticipates”, “aims”, “intends”, “would”, “could”, “should”, “will”, “plans”, “believes”, “estimates”, “targets”, “projects”, “forecasts”, “seeks” and similar words and expressions. In addition, there can be no assurance that future developments affecting us will be those that we anticipate. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing, regulatory approval, production and marketing of our products (including the First Defense® product line and Re-Tain), competition within our anticipated product markets, customer acceptance of our new and existing products, product performance, alignment between our manufacturing resources and product demand, our reliance upon third parties for financial support, products and services, changes in laws and regulations, decision making and delays by regulatory authorities, currency values and fluctuations and other risks detailed from time to time in filings we make with the SEC, including our Quarterly Reports on Form 10-Q, our Annual Reports on Form 10-K and our Current Reports on Form 8-K. Such statements involve risks and uncertainties and are based on our current expectations, but actual results may differ materially due to various factors, including the risk factors summarized above.

Jamf Announces Third Quarter 2020 Financial Results

  • Q
    3
    total
    revenue gr
    ew
    29
    % year-over-year to $
    70
    .
    4
    million
  • R
    ecurring revenue gr
    ew
    4
    0
    % year-over-year to $
    65.8
    million
  • ARR g
    rew
    3
    7
    % year-over-year to $
    2
    6
    1.5
    million

MINNEAPOLIS, Nov. 12, 2020 (GLOBE NEWSWIRE) — Jamf (NASDAQ: JAMF), the standard in Apple Enterprise Management, today announced financial results for its third quarter ended September 30, 2020.


Financial Highlights for the


Third


Quarter 2020:

  • ARR: ARR increased 37% year-over-year to $261.5 million as of September 30, 2020.
  • Revenue: Total revenue was $70.4 million, an increase of 29% year-over-year. Recurring revenue was $65.8 million, an increase of 40% year-over-year.
  • Gross Profit: GAAP gross profit was $55.2 million, or 78% of total revenue, compared to $40.5 million, or 74% of total revenue, in the third quarter of 2019. Non-GAAP Gross Profit was $58.2 million, or 83% of total revenue, compared to $43.2 million, or 79% of total revenue, in the third quarter of 2019.
  • Operating Loss/Income: GAAP operating loss was $376 thousand, compared to GAAP operating income of $205 thousand in the third quarter of 2019. Non-GAAP Operating Income was $12.0 million, or 17% of total revenue, compared to $9.6 million, or 18% of total revenue in the third quarter of 2019.
  • Cash Flow: Cash flow provided by operations was $23.6 million, compared to $15.1 million in the third quarter of 2019. Unlevered free cash flow was $28.2 million, or 40% of total revenue, compared to $17.9 million, or 33% of total revenue in the third quarter of 2019.

A reconciliation between historical GAAP and non-GAAP information is contained in the tables below and the section titled “Non-GAAP Financial Measures” below contains reconciliations of these non-GAAP financial measures.

“We delivered strong third quarter results as the tailwinds of telehealth, distance learning, and remote work offset economic headwinds and drove robust Jamf sales, growth, and customer acquisition,” said Dean Hager, CEO of Jamf. “We are dedicated to our customers’ success and continue to roll out new features and enhancements to optimize the Jamf Apple Enterprise Management platform. We showcased many of these platform enhancements at our annual Jamf Nation User Conference (JNUC), which drew ten times our normal conference attendance this year as a virtual event. We are well positioned for continued growth in a large and expanding market, and we look forward to continuing to improve the overall management, security and experience for organizations using Apple, so they can empower their end users with the native Apple experience.”


Recent Business Highlights:

  • Expanded education offering with several new capabilities, including one-click Remote Class and Raise Hand features, as well as the new Jamf Assessment app to administer proctored exams in a virtual world.
  • Grew the total number of Apple devices running Jamf to 18.6 million at the end of the third quarter.
  • Hosted approximately 20,000 attendees at the virtual JNUC, ten times the normal attendance of our annual, in-person event. Jamf showcased platform enhancements that are powering the learn, care and work anywhere trends, along with customer and partner stories on how they were able to succeed during this time using Apple and Jamf.
  • Announced same-day compatibility and key feature support across its product portfolio for Apple’s fall releases, including macOS Big Sur and support for the new Mac built with the new Apple M1 chip, which were released this week.
  • Extended collaboration with Microsoft Enterprise Mobility + Security by launching iOS Device Compliance, empowering organizations to choose Jamf for all Apple device management while also sharing important device information, like compliance status, with Microsoft Endpoint Manager.
  • Announced the acquisition of Mondada, the creator of Kinobi and Kinobi Pro, leading solutions in patch management for the Apple platform. Mondada’s solutions integrate with Jamf Pro, allowing organizations to extend Jamf Pro’s built-in patch management functionality to include all Mac applications within an environment.


Financial Outlook:

For the fourth quarter of 2020, the company currently expects:

  • Total revenue of $70 to $71 million
  • Non-GAAP Operating Income of $1 to $2 million

For the full year 2020, the company is increasing its outlook and currently expects:

  • Total revenue of $263 to $264 million
  • Non-GAAP Operating Income of $28.5 to $29.5 million


Conference Call Information:

Jamf will host a conference call and live webcast for analysts and investors at 3:30 p.m. Central Time (4:30 p.m. Eastern Time) on November 12, 2020. The news release with the financial results will be accessible from the company’s website prior to the conference call. Parties in the United States and Canada can access the call by dialing +1 (833) 519-1319, and international parties can access the call by dialing +1 (914) 800-3885.

The webcast will be accessible on Jamf’s investor relations website at https://ir.jamf.com. A telephonic replay of the conference call will be available through Thursday, November 19, 2020. To access the replay, parties should dial (855) 859-2056, or (404) 537-3406 and enter the passcode 8684837#.


Non-GAAP Financial Measures:

In addition to our results determined in accordance with generally accepted accounting principles in the United States (“GAAP”), we believe the non-GAAP measures of Non-GAAP Operating Expenses, Non-GAAP Gross Profit, Non-GAAP Gross Profit Margin, Non-GAAP Operating Income, Non-GAAP Operating Income Margin, Unlevered Free Cash Flow and Unlevered Free Cash Flow Margin are useful in evaluating our operating performance. Certain of these non-GAAP measures exclude stock-based compensation, depreciation and amortization expense, acquisition-related expenses, acquisition-related earnout, foreign currency transaction loss and discrete tax items. We believe that non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance and assists in comparisons with other companies, some of which use similar non-GAAP information to supplement their GAAP results. The non-GAAP financial information is presented for supplemental informational purposes only, and should not be considered a substitute for financial information presented in accordance with GAAP, and may be different from similarly-titled non-GAAP measures used by other companies. Reconciliation tables of the most comparable GAAP financial measures to the non-GAAP financial measures used in this press release are included with the financial tables at the end of this release.

Jamf is not providing a quantitative reconciliation of forward-looking guidance of Non-GAAP Operating Income to GAAP operating income (loss) because certain items are out of Jamf’s control or cannot be reasonably predicted. Historically, these items have included, but are not limited to, acquisition-related expenses and acquisition-related earnout, amortization and stock-based compensation. Accordingly, a reconciliation for forward-looking Non-GAAP Operating Income is not available without unreasonable effort. However, for the fourth quarter of 2020 and full year 2020 amortization is expected to be $8.3 million and $33.3 million, respectively. In addition, for the fourth quarter of 2020 and full year 2020 stock-based compensation is expected to be $2.9 million and $6.8 million, respectively. These items are uncertain, depend on various factors, and could result in projected GAAP operating income (loss) being materially less than is indicated by currently estimated Non-GAAP Operating Income.


Forward-Looking Statements:

This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including but not limited to, statements regarding our financial outlook and market positioning. Forward-looking statements give our current expectations and projections relating to our financial condition, results of operations, plans, objectives, future performance and business. You can identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. These statements may include words such as “anticipate,” “estimate,” “expect,” “project,” “plan,” “intend,” “believe,” “may,” “will,” “should,” “can have,” “likely” and other words and terms of similar meaning in connection with any discussion of the timing or nature of future operating or financial performance or other events. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that we expected, including: the impact on our operations and financial condition from the effects of the current COVID-19 pandemic; the potential impact of customer dissatisfaction with Apple or other negative events affecting Apple services and devices, and failure of enterprises to adopt Apple products; the potentially adverse impact of changes in features and functionality by Apple on our engineering focus or product development efforts; changes in our continued relationship with Apple; the fact that we are not party to any exclusive agreements or arrangements with Apple; our reliance, in part, on channel partners for the sale and distribution of our products; risks associated with cyber-security events; the impact of reputational harm if users perceive our products as the cause of device failure; our ability to successfully develop new products or materially enhance current products through our research and development efforts; our ability to continue to attract new customers; our ability to retain our current customers; our ability to sell additional functionality to our current customers; our ability to meet service-level commitments under our subscription agreements; our ability to correctly estimate market opportunity and forecast market growth; risks associated with failing to continue our recent growth rates; our dependence on one of our products for a substantial portion of our revenue; our ability to scale our business and manage our expenses; our ability to change our pricing models, if necessary to compete successfully; the impact of delays or outages of our cloud services from any disruptions, capacity limitations or interferences of third-party data centers that host our cloud services, including AWS; our ability to maintain, enhance and protect our brand; our ability to maintain our corporate culture; the ability of Jamf Nation to thrive and grow as we expand our business; the potential impact of inaccurate, incomplete or misleading content that is posted on Jamf Nation; our ability to offer high-quality support; risks and uncertainties associated with potential acquisitions and divestitures, including, but not limited to, disruptions to ongoing operations; diversions of management from day-to-day responsibilities; adverse impacts on our financial condition; failure of an acquired business to further our strategy; uncertainty of synergies; personnel issues; resulting lawsuits and issues unidentified in diligence processes; our ability to predict and respond to rapidly evolving technological trends and our customers’ changing needs; our ability to compete with existing and new companies; the impact of adverse general and industry-specific economic and market conditions; the impact of reductions in IT spending; the impact of real or perceived errors, failures or bugs in our products; the impact of interruptions or performance problems associated with our technology or infrastructure; our ability to attract and retain highly qualified personnel; risks associated with competitive challenges faced by our customers; the impact of statutory and regulatory determinations on our offerings to governmental entities; risks associated with stringent and changing privacy laws, regulations and standards, and information security policies and contractual obligations related to data privacy and security; the impact of any catastrophic events; and, risks associated with our financial results or difficulty in predicting our financial results due to our revenue recognition. Given these factors, as well as other variables that may affect Jamf’s operating results, you should not rely on forward-looking statements, assume that past financial performance will be a reliable indicator of future performance, or use historical trends to anticipate results or trends in future periods. The forward-looking statements included in this press release and on the related teleconference call relate only to events as of the date hereof. Jamf undertakes no obligation to update or revise any forward-looking statement as a result of new information, future events or otherwise, except as otherwise required by law.


About


Jamf

Jamf, the standard in Apple Enterprise Management, extends the legendary Apple experience people love to businesses, schools and government organizations through its software and the world’s largest online community of IT admins focused exclusively on Apple, Jamf Nation. To learn more, visit: www.jamf.com.

Investor Contact:

Jennifer Gaumond
[email protected]

Media Contact:

Rachel Nauen
[email protected]

Jamf Holding Corp.  
Consolidated Balance Sheets  
(In thousands)  
                 
          September 30,   December 31,  
            2020       2019    
Assets


 
    (unaudited)      
                 
Current assets:             
  Cash and cash equivalents     $ 177,457     $ 32,433    
  Trade accounts receivable, net of allowances of $513 and $200       64,151       46,513    
  Income taxes receivable       672       14    
  Deferred contract costs       8,528       5,553    
  Prepaid expenses       16,565       10,935    
  Other current assets       764       3,133    
    Total current assets       268,137       98,581    
                 
Equipment and leasehold improvements, net       10,934       12,477    
Goodwill        539,818       539,818    
Other intangible assets, net       210,120       235,099    
Deferred contract costs       23,433       16,234    
Other assets        2,842       2,599    
                 
    Total assets     $ 1,055,284     $ 904,808    
                 
Liabilities and stockholders’ equity            
                 
Current liabilities:            
  Accounts payable     $ 6,672     $ 3,684    
  Accrued liabilities       21,521       26,927    
  Income taxes payable       1,294       819    
  Deferred revenues       151,532       120,089    
    Total current liabilities       181,019       151,519    
                 
Deferred revenues, noncurrent       36,706       20,621    
Deferred tax liability       12,774       18,133    
Debt              201,319    
Other liabilities       9,399       9,338    
    Total liabilities       239,898       400,930    
                 
Commitments and contingencies            
                 
Stockholders’ equity:            
  Preferred stock                
  Common stock       117       103    
  Additional paid-in capital       894,056       568,756    
  Accumulated deficit       (78,787 )     (64,981 )  
    Total stockholders’ equity       815,386       503,878    
                 
    Total liabilities and stockholders’ equity     $ 1,055,284     $ 904,808    
                 

 

Jamf Holding Corp.  
Consolidated Statements of Operations  
(In thousands, except share and per share amounts)  
(unaudited)  
                       
        Three Months Ended September 30,   Nine Months Ended September 30,  
          2020       2019       2020       2019    
                   
Revenue:                   
  Subscription   $ 57,933     $ 41,916     $ 160,989     $ 112,872    
  Services     3,605       5,234       10,066       14,529    
  License      8,866       7,418       21,970       19,605    
    Total revenue     70,404       54,568       193,025       147,006    
                       
Cost of revenue:                  
  Cost of subscription(1) (exclusive of amortization shown below)     10,117       8,045       28,127       22,425    
  Cost of services(1) (exclusive of amortization shown below)     2,443       3,397       7,736       10,589    
  Amortization expense     2,679       2,634       8,034       7,588    
    Total cost of revenue     15,239       14,076       43,897       40,602    
                       
    Gross profit     55,165       40,492       149,128       106,404    
                       
Operating expenses:                  
  Sales and marketing(1)     23,251       16,962       65,735       48,850    
  Research and development(1)     12,736       10,919       37,282       29,453    
  General and administrative(1)     13,921       6,779       31,813       21,576    
  Amortization expense     5,633       5,627       16,941       16,886    
    Total operating expenses     55,541       40,287       151,771       116,765    
                       
    Income (loss) from operations     (376 )     205       (2,643 )     (10,361 )  
                       
Interest expense, net     (1,207 )     (5,473 )     (10,675 )     (16,425 )  
Loss on extinguishment of debt     (5,213 )           (5,213 )        
Foreign currency transaction loss     (154 )     (861 )     (471 )     (1,311 )  
Other income, net           55       91       165    
    Loss before income tax benefit     (6,950 )     (6,074 )     (18,911 )     (27,932 )  
                       
Income tax benefit     1,857       1,404       5,105       6,581    
                       
    Net loss   $ (5,093 )   $ (4,670 )   $ (13,806 )   $ (21,351 )  
                       
Net loss per share, basic and diluted   $ (0.04 )   $ (0.05 )   $ (0.13 )   $ (0.21 )  
                       
Weighted-average shares used to compute net loss per share, basic and diluted   113,203,074       102,791,023       106,333,836       102,727,198    
                       
(1) Includes stock-based compensation as follows:                  
        Three Months Ended September 30,   Nine Months Ended September 30,  
          2020       2019       2020       2019    
Cost of revenue:                  
Subscription   $ 314     $ 38     $ 390     $ 156    
Services     62             62          
Sales and marketing     675       112       897       348    
Research and development     523       99       821       284    
General and administrative     754       349       1,733       1,028    
        $ 2,328     $ 598     $ 3,903     $ 1,816    
                       

Jamf Holding Corp.  
Consolidated Statements of Cash Flows  
(In thousands)  
(unaudited)    
                       
              Nine Months Ended September 30,    
                2020       2019      
Cash flows from operating activities              
  Net loss      $ (13,806 )   $ (21,351 )    
  Adjustments to reconcile net loss to cash              
    provided by (used in) operating activities:              
    Depreciation and amortization expense       28,378       27,437      
    Amortization of deferred contract costs       6,705       4,463      
    Amortization of debt issuance costs       700       843      
    Provision for bad debt expense and returns       894            
    Loss (gain) on disposal of equipment and leasehold              
      improvements       (23 )     (11 )    
    Loss on extinguishment of debt       5,213            
    Share-based compensation       3,903       1,816      
    Deferred taxes       (5,357 )     (6,867 )    
    Adjustment to contingent consideration       (3,100 )          
    Changes in operating assets and liabilities:              
      Trade accounts receivable       (18,332 )     (13,046 )    
      Income tax receivable/payable       (183 )     (246 )    
      Prepaid expenses and other assets       (4,699 )     (4,888 )    
      Deferred contract costs       (16,879 )     (12,684 )    
      Accounts payable       3,145       (836 )    
      Accrued liabilities       (4,207 )     1,151      
      Deferred revenue       47,528       29,597      
      Other liabilities       3,161       (11 )    
        Net cash provided by operating activities       33,041       5,367      
                       
Cash flows from investing activities              
  Acquisition, net of cash acquired             (40,173 )    
  Purchases of equipment and leasehold improvements       (1,836 )     (6,164 )    
        Net cash used in investing activities       (1,836 )     (46,337 )    
                       
Cash flows from financing activities              
  Proceeds from debt             40,000      
  Debt issuance costs       (1,264 )     (1,550 )    
  Payment of debt       (205,000 )     (4,750 )    
  Payment of debt extinguishment costs       (2,050 )          
  Proceeds from initial public offering, net of underwriting discounts and commissions       326,316            
  Cash paid for offering costs       (6,601 )          
  Proceeds from private placement       2,233            
  Proceeds from the exercise of stock options       185       820      
        Net cash provided by financing activities       113,819       34,520      
                       
        Net increase (decrease) in cash       145,024       (6,450 )    
                       
Cash, beginning of period       32,433       39,240      
                       
Cash, end of period     $ 177,457     $ 32,790      
                       

  

Jamf Holding Corp.  
Supplemental Financial Information  
Disaggregated Revenues  
(In thousands)  
(unaudited)  
                   
    Three Months Ended September 30,   Nine Months Ended September 30,  
      2020     2019     2020     2019  
                           
               
SaaS subscription and support and maintenance   $ 57,933   $ 41,916   $ 160,989   $ 112,872  
On-premise subscription     7,849     5,135     18,159     12,224  
Recurring revenue     65,782     47,051     179,148     125,096  
                   
Perpetual licenses     1,017     2,283     3,811     7,381  
Professional services     3,605     5,234     10,066     14,529  
Non-recurring revenue     4,622     7,517     13,877     21,910  
Total revenue   $ 70,404   $ 54,568   $ 193,025   $ 147,006  
                   

 

Jamf Holding Corp.  
Supplemental Financial Information  
Reconciliation of GAAP to non-GAAP Financial Data  
(In thousands, except share and per share amounts)  
(unaudited)  
                 
  Three Months Ended September 30,   Nine Months Ended September 30,  
    2020       2019       2020       2019    
Operating expenses $ 55,541     $ 40,287     $ 151,771     $ 116,765    
Amortization expense   (5,633 )     (5,627 )     (16,941 )     (16,886 )  
Stock-based compensation   (1,952 )     (560 )     (3,451 )     (1,660 )  
Acquisition-related expense   (1,092 )     (488 )     (4,328 )     (1,392 )  
Acquisition-related earnout   (600 )           3,100          
Non-GAAP Operating Expenses $ 46,264     $ 33,612     $ 130,151     $ 96,827    
                 
  Three Months Ended September 30,   Nine Months Ended September 30,  
    2020       2019       2020       2019    
Gross profit $ 55,165     $ 40,492     $ 149,128     $ 106,404    
Amortization expense   2,679       2,634       8,034       7,588    
Stock-based compensation   376       38       452       156    
Non-GAAP Gross Profit $ 58,220     $ 43,164     $ 157,614     $ 114,148    
Non-GAAP Gross Profit Margin   83 %     79 %     82 %     78 %  
                 
  Three Months Ended September 30,   Nine Months Ended September 30,  
    2020       2019       2020       2019    
Operating income (loss) $ (376 )   $ 205     $ (2,643 )   $ (10,361 )  
Stock-based compensation   2,328       598       3,903       1,816    
Acquisition-related expense   1,092       488       4,328       1,392    
Amortization expense   8,312       8,261       24,975       24,474    
Acquisition-related earnout   600             (3,100 )        
Non-GAAP Operating Income $ 11,956     $ 9,552     $ 27,463     $ 17,321    
Non-GAAP Operating Income Margin   17 %     18 %     14 %     12 %  
                 
  Three Months Ended September 30,   Nine Months Ended September 30,  
    2020       2019       2020       2019    
Net loss $ (5,093 )   $ (4,670 )   $ (13,806 )   $ (21,351 )  
Stock-based compensation   2,328       598       3,903       1,816    
Acquisition-related expense   1,092       488       4,328       1,392    
Amortization expense   8,312       8,261       24,975       24,474    
Acquisition-related earnout   600             (3,100 )        
Loss on extinguishment of debt   5,213             5,213          
Foreign currency transaction loss   154       861       471       1,311    
Discrete tax items   (1,389 )     42       (1,599 )     66    
Benefit for income taxes (1)   (3,050 )     (2,494 )     (7,470 )     (7,083 )  
Non-GAAP Net Income $ 8,167     $ 3,086     $ 12,915     $ 625    
Net loss per share:                
Basic $ (0.04 )   $ (0.05 )   $ (0.13 )   $ (0.21 )  
Diluted $ (0.04 )   $ (0.05 )   $ (0.13 )   $ (0.21 )  
Weighted-average shares used in computing net loss per share:                
Basic   113,203,074       102,791,023       106,333,836       102,727,198    
Diluted   113,203,074       102,791,023       106,333,836       102,727,198    
Non-GAAP Net Income per Share:                
Basic $ 0.07     $ 0.03     $ 0.12     $ 0.01    
Diluted $ 0.07     $ 0.03     $ 0.12     $ 0.01    
Weighted-average shares used in computing Non-GAAP Net Income per Share:                
Basic   113,203,074       102,791,023       106,333,836       102,727,198    
Diluted   116,688,193       104,600,602       109,188,051       103,701,743    
                 
(1) The related tax effects of the adjustments to Non-GAAP Net Income were calculated using the respective statutory tax rates for applicable jurisdictions, which is not materially different from our annual effective tax rate of approximately 25%.  
 
                 
  Three Months Ended September 30,   Nine Months Ended September 30,  
    2020       2019       2020       2019    
Net cash provided by operating activities $ 23,608     $ 15,086     $ 33,041     $ 5,367    
Add:                
Cash paid for interest   3,385       5,217       12,647       15,785    
Cash paid for acquisition-related expense   1,700       488       3,300       1,392    
Less:                
Purchases of equipment and leasehold improvements   (494 )     (2,845 )     (1,836 )     (6,164 )  
Unlevered free cash flow $ 28,199     $ 17,946     $ 47,152     $ 16,380    
Unlevered free cash flow margin   40 %     33 %     24 %     11 %  
                 

Opiant Pharmaceuticals Announces Third Quarter 2020 Financial Results and Corporate Update

SANTA MONICA, Calif., Nov. 12, 2020 (GLOBE NEWSWIRE) — Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ: OPNT), a specialty pharmaceutical company developing medicines to treat addictions and drug overdose, today reported financial results for the three months ended September 30, 2020, and provided a corporate update. Recent highlights include:


  • OPNT003 nasal nalmefene for opioid overdose


     
    –  Opiant to use Aptar Pharma’s Unit Dose System
    –  Upcoming FDA meeting in December to review Pharmacodynamic study in healthy volunteers and 505(b)(2) submission strategy
    –  Opiant continues to expect to file a New Drug Application by end of 2021
    –  The Centers for Disease Control and Prevention reports an increase in fatal drug overdoses in the first three months of 2020 putting the U.S. on pace for record year of drug overdose deaths during coronavirus pandemic
     

  • Q3 revenues of $9.1 million driven by
    NARCAN® Nasal Spray (“NARCAN®”) royalties
     
    –  Recognized approximately $8.6 million in royalty revenue for Q3 2020 from approximately $88.8 million in net sales of NARCAN® Nasal Spray
    –  Projected royalties for the full-year 2020 raised from $26.2 million to approximately $28 million, based on Emergent Biosolutions (“EBS”) updated revenue guidance for NARCAN® sales of between $295 million and $315 million
     

  • $31.1 million in cash and cash equivalents

Commenting on the quarter, Roger Crystal, M.D., President and Chief Executive Officer of Opiant, said:

“Deaths from overdoses on opioids remain a crisis for communities across the United States, exacerbated by the COVID-19 pandemic. The determined deployment of opioid overdose rescue medication is essential to save lives. The trajectory of America’s opioid crisis, fueled by the availability of fentanyl and related synthetic opioids, underscores the need for stronger, longer-acting formulations of opioid antagonists. To this end, we made good progress this quarter with OPNT003 nasal nalmefene, our investigational treatment for opioid overdose. I am pleased we can now use Aptar Pharma’s Unit Dose System for OPNT003, which has been approved by the FDA with many other drug products, including NARCAN® Nasal Spray. Adding to the momentum, we will meet with the FDA in December to review the design of our pharmacodynamic study in healthy volunteers and our New Drug Application plan, which is on track to be submitted by the end of next year.”

David O’Toole, Chief Financial Officer of Opiant, said:

“Royalties from net sales of NARCAN® Nasal Spray continue to fortify our already strong balance sheet. EBS reported higher sales than expected this quarter and raised their NARCAN® revenue guidance for the year to a range of $295 million to $315 million. Based on this we have increased our projection of royalty revenue for the full year to approximately $28 million. We also now expect a cash balance at the end of 2020 of approximately $30 million.”

Third Quarter 2020 Results

For the three months ended September 30, 2020, Opiant recorded approximately $9.1 million in revenue, compared to approximately $20.6 million during the corresponding period of 2019. For the three months ended September 30, 2020, we recorded approximately $8.6 million of revenue from our license agreement with EBS for the sale of NARCAN®, compared to approximately $20.5 million in the same period of 2019 which included a final milestone payment of $13.5 million, as sales of NARCAN® Nasal Spray exceeded $200 million for 2019. Third quarter 2020 sales of NARCAN® were approximately $88.8 million, as reported by EBS.

General and administrative expenses for the quarter were approximately $2.7 million, compared to $3.2 million for the same period in 2019. The $0.5 million decrease was primarily attributable to a decrease in legal and professional fees of approximately $0.8 million, partially offset by an increase in personnel and related expense of $0.3 million for the three months ended September 30, 2020 compared to the three months ended September 30, 2019. 

Research and development expenses were approximately $2.8 million, as compared to approximately $1.8 million in the third quarter of 2019. External development expense increased by $0.8 million and personnel and related expense increased by approximately $0.2 million during the three months ended September 30, 2020 compared to the three months ended September 30, 2019.

Sales and marketing expenses were approximately $0.9 million, as compared to approximately $0.1 million in the third quarter of 2019. The $0.8 million increase was attributable to pre-commercialization efforts related to OPNT003 nasal nalmefene, which is under clinical development. 

Royalty expense for the second quarter was approximately $2 million compared to $4.9 million for the same period in 2019. Royalty expense is for payments that we make to our net profit partners on the royalties we received from the net sales of NARCAN®.

Net income for the third quarter was approximately $0.7 million, or $0.17 per basic and $0.15 per diluted share, compared to net income of approximately $10.7 million, or $2.64 per basic and $1.97 per diluted share, for the comparable period of 2019.

Financial Results for the Nine Months Ended September 30, 2020

For the nine months ended September 30, 2020, Opiant recorded approximately $19.7 million in revenue, compared to approximately $32.9 million during the corresponding period of 2019. For the nine months ended September 30, 2020, we recognized approximately $19.1 million of revenue from our license agreement with EBS for the sale of NARCAN®, compared to approximately $30.4 million in the comparable period of 2019. The decrease in revenue of approximately $11.3 million was primarily attributable to a milestone payment of $13.5 million earned in the third quarter of 2019, as sales of NARCAN® exceeded $200 million for 2019, offset by an increase in royalties as a result of and increase in net sales of NARCAN® for the nine months ended September 30, 2020. Sales of NARCAN® for the nine months ended September 30, 2020, were approximately $233.8 million, as reported by EBS. 

General and administrative expenses for the nine months ended September 30, 2020, were approximately $8.1 million, compared to approximately $9.4 million in the comparable period of 2019. The decrease of $1.3 million was primarily due to a $1.5 million decrease in legal and professional fees, partially offset by a $0.2 million increase in personnel and related expense including stock based compensation for the nine months ended September 30, 2020 compared to the nine months ended September 30, 2019.

Research and development expenses for the nine months ended September 30, 2020, were approximately $4.8 million, compared to approximately $7.0 million in the comparable period of 2019. The decrease of $2.2 million resulted from a decrease in third party clinical trial and development expense of $2.5 million, partially offset by an increase in personnel and related expense of $0.3 million.

Sales and marketing expenses for the nine months ended September 30, 2020, were approximately $3.7 million, compared to $0.1 million during the same period 2019. For the nine months ended September 30, 2020 personnel and related expense including stock based compensation was $0.9 million, and $2.8 million was related to third party expenses for various pre-commercial activities including market research and assessments, and strategic planning.

Royalty expenses were $4.3 million and $6.1 million during the nine months ended September 30, 2020 and 2019, respectively. Royalty expense is for payments that we make to our net profit partners on the royalties we received from the net sales of NARCAN®.

Net loss for the nine months ended September 30, 2020, was approximately $1.2 million, or a loss of $0.28 per basic and diluted share, compared to a net income of approximately $10.6 million, or $2.64 per basic share and $1.98 per diluted share, for the comparable period of 2019.

As of September 30, 2020, Opiant had cash and cash equivalents of $31.1 million, compared to approximately $31 million at December 31, 2019. The current cash balance does not include the full impact of the NIDA grant that we previously received of approximately $7.4 million or the BARDA contract of approximately $4.6 million.


Conference Call Details:


Thursday, November 12

th

at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time

Toll Free:   877-407-0792
International:   201-689-8263
Conference ID:   13712206
Webcast:   http://ir.opiant.com/


About Opiant Pharmaceuticals, Inc.

Opiant Pharmaceuticals, Inc., the company that developed NARCAN® Nasal Spray, is building a leading franchise of new medicines to combat addictions and drug overdose.

For more information visit: www.opiant.com.


Forward-Looking Statements


This press release contains forward-looking statements. These statements relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed, implied or inferred by these forward-looking statements, and among other things, our ability to maintain cash balances and successfully commercialize or partner our product candidates currently under development. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “intends,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” or “continue” or the negative of such terms and other same terminology. These statements are only predictions based on our current expectations and projections about future events. You should not place undue reliance on these statements. Actual events or results may differ materially. In evaluating these statements, you should specifically consider various factors. Additional factors that could materially affect actual results can be found in our filed quarterly reports on Form 10-Q and our annual report on Form 10-K for the year ended December 31, 2019, filed with the Securities and Exchange Commission on March 4, 2020, including under the caption titled “Risk Factors.” These and other factors may cause our actual results to differ materially from any forward-looking statement. We undertake no obligation to update any of the forward-looking statements after the date of this press release to conform those statements to reflect the occurrence of unanticipated events, except as required by applicable law.

Investor Relations Contacts:

Ben Atkins

VP of Corporate Communications and Investor Relations
[email protected]
(310) 598-5410

Dan Ferry

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

Opiant Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except shares and per share amounts)
         
    As of September 30,   As of December 31,
    2020   2019
Assets   (unaudited)    
Current Assets        
Cash & cash equivalents   $ 31,103     $ 30,981  
Accounts receivable     8,613       7,218  
Prepaid expenses and other current assets     862       1,056  
Total Current Assets     40,578       39,255  
Long-term Assets        
Property and equipment, net of depreciation     202       243  
Right of use assets – operating leases     397       769  
Patents and patent applications, net of amortization     13       14  
Other non-current assets     1,052        
Total Assets   $ 42,242     $ 40,281  
         
Liabilities and stockholders’ equity        
Current Liabilities        
Accounts payable and accrued expenses   $ 2,553     $ 1,317  
Accrued salaries & wages     1,435       1,238  
Royalty payable     1,952       1,620  
Deferred revenue     360       918  
Operating leases – current     401       517  
Total Current Liabilities     6,701       5,610  
Long-Term Liabilities        
Operating leases – long term           255  
Total Long-Term Liabilities           255  
Total Liabilities     6,701       5,865  
Stockholders’ equity        
Common stock, $0.001 par value, 200,000,000 shares        
authorized, 4,258,105 and 4,186,438 shares        
issued and outstanding at September 30, 2020 and        
December 31, 2019, respectively     4       4  
Additional paid-in-capital     99,655       97,239  
Foreign Currency Translation Adjustment     (115 )      
Accumulated deficit     (64,003 )     (62,827 )
Total stockholders’ equity     35,541       34,416  
Total liabilities and stockholders’ equity   $ 42,242     $ 40,281  

Opiant Pharmaceuticals Inc.
Condensed Consolidated Statements of Operations
(in thousands, except shares and per share amounts)
(unaudited)
                 
    Three months ended   Nine months ended
    September 30,   September 30,
      2020       2019       2020       2019  
                 
Revenues                
Royalty & licensing revenue   $ 8,601     $ 20,494     $ 19,057     $ 30,368  
Treatment investment revenue                       644  
Grant and contract revenue     505       147       644       1,838  
Total Revenue     9,106       20,641       19,701       32,850  
Operating expenses                
General and administrative     2,729       3,211       8,138       9,389  
Research and development     2,784       1,843       4,763       7,044  
Sales and marketing     914       141       3,738       141  
Royalty expense     1,952       4,851       4,289       6,099  
Total operating expenses     8,379       10,046       20,928       22,673  
                 
Income (loss) from operations     727       10,595       (1,227 )     10,177  
                 
Other income (expense)                
Interest income     4       112       92       356  
Gain (loss) on foreign exchange     (6 )     (24 )     (2 )     (65 )
Total other income     (2 )     88       90       291  
Income (loss) before income taxes     725       10,683       (1,137 )     10,468  
Income tax (expense) benefit                 (39 )     57  
Net income (loss)   $ 725     $ 10,683     $ (1,176 )   $ 10,525  
                 
Other comprehensive loss                
Foreign currency translation adjustment     196             (115 )      
Total other comprehensive loss   $ 921     $ 10,683     $ (1,291 )   $ 10,525  
                 
Net income (loss) per common share                
Basic   $ 0.17     $ 2.64     $ (0.28 )   $ 2.64  
Diluted   $ 0.15     $ 1.97     $ (0.28 )   $ 1.98  
                 
Weighted-average common shares outstanding:              
Basic     4,258,105       4,048,635       4,247,045       3,985,112  
Diluted     4,847,211       5,422,345       4,247,045       5,310,157  

 

Wright Medical Announces Fundamental Change With Respect to the 2.25% Cash Convertible Senior Notes due 2021 issued by Wright Medical Group N.V. and the 1.625% Cash Exchangeable Senior Notes due 2023 issued by Wright Medical Group, Inc.

AMSTERDAM, The Netherlands, Nov. 12, 2020 (GLOBE NEWSWIRE) — Wright Medical today announced that in connection with the tender offer (the “Tender Offer”) and the mergers (the “Mergers”) pursuant to which Wright Medical Group N.V. (“WMG”) was acquired by Stryker Corporation, Stryker Unite, Ltd. (formerly Wright Medical Ltd.) succeeded to and assumed any and all obligations of WMG under the indentures governing the 2.25% Cash Convertible Senior Notes due 2021 issued by WMG (the “2021 Notes”) and the 1.625% Cash Convertible Senior Notes due 2023 issued by Wright Medical Group, Inc. (the “2023 Notes”). In connection with the closing of the Mergers, the name of Wright Medical Ltd. (as successor to WMG) was changed to Stryker Unite, Ltd.

Pursuant to the indentures governing the 2021 Notes and the 2023 Notes, the consummation of the Tender Offer and the related securities filing made in connection with the Tender Offer, and the consummation of each of the Mergers, each constituted a “Fundamental Change” and a “Make-Whole Fundamental Change” under, and as defined in, such indentures. The “Effective Date” (as defined in each indenture) of the Fundamental Change and Make-Whole Fundamental Change in connection with each of the Mergers was November 11, 2020 and in connection with the Tender Offer was November 12, 2020. The “Fundamental Change Repurchase Date” (as defined in each indenture) will be December 8, 2020. In connection with the Make-Whole Fundamental Change, the conversion rate of the 2021 Notes will be adjusted to 47.4849, and the exchange rate of the 2023 Notes will be adjusted to 34.5507, in each case for any conversions between November 11, 2020 and December 7, 2020. In connection with the Mergers, the “Reference Property” per ordinary share of WMG, under and as defined in each Indenture, will be $30.75.

Investors & Media:

Julie D. Dewey, IRC
Sr. Vice President, Chief Communications Officer
Wright Medical Group N.V.
(901) 290-5817
[email protected]

Relay Therapeutics Reports Third Quarter 2020 Financial Results

CAMBRIDGE, Mass., Nov. 12, 2020 (GLOBE NEWSWIRE) — Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by leveraging unparalleled insights into protein motion, today reported third quarter 2020 financial results.

“In our first quarter as a public company, I am proud of our team’s unwavering focus on bringing our medicines to patients,” said Sanjiv Patel, M.D., president and chief executive officer of Relay Therapeutics. “In July, we completed and closed our initial public offering. In September, we dosed the first patient with our second targeted medicine, RLY-4008, the only selective small molecule inhibitor of FGFR2 in clinical development. We look forward to providing updates across our pipeline in 2021.”

Second
Quarter Financial Highlights

Cash and Cash Equivalents: Cash, cash equivalents and investments totaled approximately $713 million as of September 30, 2020, which includes the net proceeds of $425 million from the Company’s initial public offering, compared to $356 million as of December 31, 2019. The Company expects its current cash and cash equivalents will be sufficient to fund its current operating plan into 2023.

R&D Expenses: Research and development expenses were $24 million for the third quarter of 2020, as compared to $18 million for the third quarter of 2019. This increase was primarily due to higher personnel costs, including an increase of $4.6 million in non-cash stock-based compensation expenses related to the accounting treatment of certain options granted in the first quarter of 2020, as well as an increase in costs to support our clinical trials, offset in part by a decrease in outside and consulting services for our pre-clinical candidates.

G&A Expenses: General and administrative expenses were $12 million for the third quarter of 2020, as compared to $4 million for the third quarter of 2019. This increase was primarily due to higher personnel costs, including an increase of $6.0 million in non-cash stock-based compensation expenses related to the accounting treatment of certain options granted in the first quarter of 2020, to support our infrastructure.

Net Loss: Net loss was $36 million for the third quarter of 2020, or a net loss per share of $3.00, as compared to a net loss of $20 million for the third quarter of 2019, or a net loss per share of $5.53.

About Relay Therapeutics

Relay Therapeutics (Nasdaq: RLAY) is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, Relay Therapeutics aims to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. The Company’s Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. For more information, please visit www.relaytx.com or follow us on Twitter.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the Company’s strategy, business plans and focus; the progress and timing of updates on the clinical development of the programs across the Company’s portfolio; and expectations regarding our cash runway and the use of capital, expenses, future accumulated deficit and other financial results in the future. The words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target” and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: the impact of COVID-19 on countries or regions in which we have operations or do business, as well as on the timing and anticipated results of our clinical trials, strategy and future operations; the delay of any current or planned clinical trials or the development of the Company’s drug candidates, including, but not limited to, RLY-1971 and RLY-4008; the risk that the results of our clinical trials may not be predictive of future results in connection with future clinical trials; the Company’s ability to successfully demonstrate the safety and efficacy of its drug candidates; the timing and outcome of the Company’s planned interactions with regulatory authorities; and obtaining, maintaining and protecting its intellectual property.  These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Relay Therapeutics’ most recent Quarterly Report on Form 10-Q as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Relay Therapeutics’ views only as of today and should not be relied upon as representing its views as of any subsequent date. Relay Therapeutics explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

Contact:
Pete Rahmer, Head of Investor Relations and Communications
617-322-0715
[email protected]

Media:
Dan Budwick
1AB
973-271-6085
[email protected]


Relay Therapeutics, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
(Unaudited)

  Three Months Ended

September 30,
  Nine Months Ended
September 30,



 
  2020     2019     2020     2019  
Operating expenses:        
Research and development expenses $ 24,376     $ 18,256     $ 67,739     $ 47,899  
General and administrative expenses   12,231       3,652       23,045       10,316  
Total operating expenses   36,607       21,908       90,784       58,215  
Loss from operations   (36,607 )     (21,908 )     (90,784 )     (58,215 )
Other income (expense):        
Interest income   534       2,236       3,104       6,881  
Other expense   (5 )     (1 )     (8 )     (58 )
Total other income (expense), net   529       2,235       3,096       6,823  
Net loss $ (36,078 )   $ (19,673 )   $ (87,688 )   $ (51,392 )
Deemed dividend resulting from extinguishment upon modification
  of series C preferred stock
  (177,789 )           (177,789 )      
Net loss attributable to common stockholders $ (213,867 )   $ (19,673 )   $ (265,477 )   $ (51,392 )
Net loss attributable to common stockholders per share, basic and
  diluted
$ (3.00 )   $ (5.53 )   $ (9.92 )   $ (15.46 )
Weighted average shares of common stock, basic and diluted   71,248,846       3,556,303       26,766,687       3,323,456  
         

Relay Therapeutics, Inc.
Selected Condensed Consolidated Balance Sheet Data
(In thousands)
(Unaudited)

  September
 30,

2020
  December 31,
2019  
     
Cash, cash equivalents and investments $ 713,466   $ 355,816
Working capital (1)   706,184     348,550
Total assets   751,681     393,068
Total liabilities   38,156     35,725
Convertible preferred stock       537,781
Total stockholders’ equity (deficit)   713,525     (180,438)
Restricted cash   878     878
     
(1)   Working capital is defined as current assets less current liabilities.    

 

Eton Pharmaceuticals Announces Third Quarter 2020 Financial Results

DEER PARK, Ill., Nov. 12, 2020 (GLOBE NEWSWIRE) — Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases, today reported financial results for the third quarter ended September 30, 2020 and provided an update on business progress.


“In recent weeks we submitted the last of our nine product candidates to the FDA. This is a tremendous accomplishment by our team after years of hard work. We are now turning our focus to building out a leading orphan drug commercial organization,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals. “Early interest in ALKINDI SPRINKLE from physicians and caregivers has been very strong and has reiterated the significant need for the product.”


Recent Business Milestones

  • FDA approval of orphan product ALKINDI® SPRINKLE. In September, ALKINDI SPRINKLE was approved by the FDA as a replacement therapy for Adrenocortical Insufficiency in patients under 17 years of age. Eton expects to have the product commercially available by the end of November.

  • FDA approval of Alaway Preservative Free®. During the quarter, Alaway Preservative Free was approved by the FDA. Bausch Health plans to launch the product by the Spring of 2021 and Eton will receive a royalty on sales of the product.

  • Four additional NDAs submitted to the FDA. Eton, or its partners, have submitted four NDAs in the second half of 2020. Dehydrated alcohol injection, zonisamide oral suspension, and ephedrine injection have all been accepted for filing and assigned PDUFA dates of May 27, 2021; May 29, 2021; and June 18, 2021, respectively.

  • Successful completion of equity financing. In October, Eton closed an oversubscribed common stock offering which resulted in gross proceeds of approximately $22.5 million. The proceeds are expected to be sufficient to allow Eton to launch its current pipeline products and reach profitability.




ALKINDI SPRINKLE

Eton anticipates having commercial availability of ALKINDI SPRINKLE by the end of November. The company’s ALKINDI SPRINKLE sales representatives have been hired, fully trained, and have begun engaging with pediatric endocrinologists. Initial interest from physicians, caregivers, and patients has been very strong and Eton expects the product to exceed the company’s original sales forecast for 2021.




Biorphen

The company remains on schedule to file a Prior Approval Supplement for Biorphen vials in the fourth quarter of 2020, which should allow for a launch of the vial product in the first half of 2021. Customer feedback continues to show aversion to the ampule format but strong interest in the product in vial form.




Pipeline Update


Product Regulatory Status
Biorphen® Commercial
ALKINDI® SPRINKLE Approved
Alaway Preservative Free® Approved
Dehydrated Alcohol Inj. (DS-100) Filed
Lamotrigine Oral Susp. (ET-105) Filed
Zonisamide Oral Susp. (ET-104) Filed
Cysteine Inj. (DS-300) Filed
Ephedrine Injection (ET-203) Filed
Topiramate Oral Soln (ET-101) Submitted



Dehydrated Alcohol Injection (DS-100).
During the quarter, Eton submitted an NDA for the product and the application was accepted for filing. The application has been assigned a PDUFA date of May 27, 2021.

Lamotrigine Oral Suspension (ET-105). The product’s human factors study is ongoing. One of the three requested arms has been completed, and the two remaining arms are ongoing. Eton expects the study to be completed and submitted to the FDA in the coming months, allowing for potential FDA approval as early as the first half of 2021.

Zonisamide Oral Suspension (ET-104). During the quarter, Eton submitted an NDA for the product and the application was accepted for filing. The application has been assigned a PDUFA date of May 29, 2021.

Cysteine Injection (DS-300). In October, Eton’s Abbreviate New Drug Application received a complete response letter from the FDA with only minor deficiencies. Eton expects to respond to the request in December, which should allow the application to receive tentative approval as early as the first quarter of 2021. The company’s paragraph IV litigation and post grant review (PGR) challenges are ongoing. Eton remains confident the innovator’s patents will be invalidated, and the company believes its product could launch as early as November 2021 if the PGR process is successful or August 2022 when the 30-month stay expires.

Ephedrine Injection (ET-203). Eton’s partner submitted the product’s NDA during the quarter and the application has been accepted for filing by the FDA. The NDA has been assigned a PDUFA date of June 18, 2021.

Topiramate Oral Solution (ET-101). Eton submitted an NDA for the product in October 2020. If the application is accepted for filing, Eton would expect it to be assigned a PDUFA date of Q3 2021.




Financial Results

Revenue: Eton reported revenue of ($0.2) million for the third quarter of 2020. During the quarter, Eton lowered the list price of Biorphen, which resulted in a $0.2 million reduction to revenue due to a shelf stock adjustment charge tied to inventory on hand with wholesale customers. Eton reported no revenue in the third quarter of 2019.

Selling, General, & Administrative (SG&A): SG&A expenses in the third quarter of 2020 were $3.4 million compared with $1.6 million in the prior year period. The increase was driven by higher sales and marketing spending in advance of the ALKINDI SPRINKLE launch, paragraph IV litigation expenses related to the company’s cysteine injection patent challenge, and higher non-cash stock-based compensation in the period.

Research & Development (R&D): R&D expenses in the third quarter of 2020 were $2.8 million compared with $3.4 million in the prior year period. The third quarter of 2020 included a $1.5 million NDA filing fee paid to the FDA. The third quarter of 2019 included a $2.0 million licensing payment related to the lamotrigine product.

Net Loss: Eton reported a net loss of $6.5 million in the third quarter of 2020 compared to a net loss of $5.0 million for the same period in 2019.

Cash Position: As of September 30, 2020, Eton reported cash and cash equivalents of $7.3 million. Subsequent to the quarter end, Eton closed an equity financing which resulted in gross proceeds of approximately $22.5 million.

Conference Call and Webcast Information:

Eton Pharmaceuticals will host a conference call and webcast today at 4:30 p.m. ET (3:30 p.m. CT). To access the conference call, please dial 1-866-795-8473 (domestic) or 1-470-495-9161 (international) and refer to conference ID 5092872. The webcast can be accessed under “Events & Presentations” in the Investors section of the Company’s website at https://ir.etonpharma.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days.

About Eton Pharmaceuticals

Eton Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases. The company currently owns or receives royalties from three FDA-approved products, including ALKINDI® SPRINKLE, Biorphen®, and Alaway Preservative Free®, and has six additional products that have been submitted to the FDA.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited to statements regarding Eton’s business strategy, Eton’s plans to develop and commercialize its product candidates, the safety and efficacy of Eton’s product candidates, Eton’s plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton’s product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Eton’s development programs and financial position are described in additional detail in Eton’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.



Eton Pharmaceuticals, Inc.

Condensed Statements of Operations

(In thousands, except per share amounts)

(Unaudited)

   
For the three months ended
   
For the


nine


months ended
 
 
September 30,
   
September 30,
    September 30,     September 30,  
  2020     2019     2020     2019  
Revenues:                          
Product sales, net $ (161 )   $     $ (42 )   $  
Licensing revenue                     500  
Total revenues   (161 )           (42 )     500  
                               
Cost of product sales   (144 )           (14 )      
                               
Gross (loss) profit   (
17
)           (
28
)     500  
                               
Operating expenses:                              
Research and development   2,826       3,418       10,703       11,322  
General and administrative   3,429       1,624       8,960       5,123  
Total operating expenses   6
,
255
      5
,
042
      19
,
663
      16
,
445
 
                               
Loss from operations   (6,272 )     (5,042 )     (19,691 )     (15,945 )
                               
Other (expense) income:                              
Interest and other (expense) income, net   (232 )     77       (592 )     321  
                               
Loss before income tax expense   (6,504 )     (4,965 )     (20,283 )     (15,624 )
                               
Income tax expense                      
                               
Net loss $ (6,504 )   $ (4,965 )   $ (20,283 )   $ (15,624 )
Net loss per share, basic and diluted $ (0.
31
)   $ (0
.28
)   $ (
1
.
01
)   $ (0.
88
)
Weighted average number of common shares outstanding, basic and diluted   21,052       17,878       20,070       17,706  



Eton Pharmaceuticals, Inc.

Condensed Balance Sheets

(in thousands, except share and per share amounts)

  September 30, 2020     December 31, 2019  
  (Unaudited)        
Assets              
Current assets:              
Cash and cash equivalents $ 7,332     $ 12,066  
Accounts receivable, net         473  
Inventory   1,699       380  
Prepaid expenses and other current assets   754       2,090  
Total current assets   9,785       15,009  
               
Property and equipment, net   854       1,117  
Intangible assets, net   612       725  
Operating lease right-of-use assets, net   63       160  
Other long-term assets, net   81       61  
Total assets $ 11,395     $ 17,072  
               
Liabilities and stockholders’ equity              
Current liabilities:              
Accounts payable $ 2,208     $ 575  
PPP loan, current portion   219        
Accrued liabilities   792       1,388  
Total current liabilities   3,219       1,963  
               
Long-term debt, net of discount and including accrued fees   6,496       4,540  
Long-term portion of PPP and EIDL loans   292        
Operating lease liabilities, net of current portion         19  
               
Total liabilities   10
,
007
      6,522  
               
Commitments and contingencies (Note 11)              
               
Stockholders’ equity              
Common stock, $0.001 par value; 50,000,000 shares authorized as of September 30, 2020 and December 31, 2019; 20,988,533 and 17,877,486 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively   21       18  
Additional paid-in capital   85,838       74,720  
Accumulated deficit   (84,471 )     (64,188 )
Total stockholders’ equity   1,388       10,550  
               
Total liabilities and stockholders’ equity $ 11,395     $ 17,072  



Eton Pharmaceuticals, Inc.

Condensed Statements of Cash Flows

(In thousands)

(Unaudited)

  Nine months ended
September 30, 2020
    Nine months ended 

September 30, 2019
 
Cash flows from operating activities              
Net loss $ (20,283 )   $ (15,624 )
               
Adjustments to reconcile net loss to net cash used in operating activities:              
Stock-based compensation   1,803       1,387  
Common stock issued for product candidate licensing rights   1,264        
Depreciation and amortization   490       299  
Debt discount amortization   85        
Changes in operating assets and liabilities:              
Accounts receivable   473        
Inventory   (1,319 )      
Prepaid expenses and other assets   1,305       426  
Accounts payable   1,633       (403 )
Accrued liabilities   (615 )     (263 )
Net cash used in operating activities   (15,164 )     (14,178 )
               
Cash used in investing activities              
Purchases of property and equipment   (6 )     (1,062 )
               
Cash flows from financing activities              
Proceeds from issuance of long-term debt, net of issuance costs   1,965        
Proceeds from sales of common stock, net of offering costs   7,756        
Proceeds from PPP and EIDL loans   511        
Proceeds from employee stock purchase plan and stock option exercises   204       282  
Net cash provided by financing activities   10,436       282  
               
Change in cash and cash equivalents   (4,734     (14,958 )
Cash and cash equivalents at beginning of period   12,066       26,735  
Cash and cash equivalents at end of period $ 7,332     $ 11,177  
               
Supplemental disclosures of cash flow information              
Cash paid for interest $ 545     $  
Cash paid for income taxes $     $  
               
Supplemental disclosure of non-cash financing activity              
Relative fair value of common stock warrants issued in connection with debt $ 94     $  



Investor Contact:

David Krempa
[email protected]
612-387-3740

Neuronetics to Present at the Canaccord Genuity Virtual MedTech & Diagnostics Forum

MALVERN, Pa., Nov. 12, 2020 (GLOBE NEWSWIRE) — Neuronetics, Inc. (NASDAQ: STIM), a commercial stage medical technology company focused on designing, developing and marketing products that improve the quality of life for patients who suffer from psychiatric disorders, today announced that the management team will present at the Canaccord Genuity Virtual MedTech & Diagnostics Forum on Thursday, November 19, 2020 at 12:30pm ET.

A live audio webcast of the conference presentation will be available online at the investor relations page of the Company’s website at ir.neuronetics.com. A replay of the webcast will be archived on the website for approximately 90 days.

About Neuronetics

Neuronetics, Inc. is a commercial-stage medical technology company focused on designing, developing, and marketing products that improve the quality of life for patients who suffer from psychiatric disorders. Our first commercial product, the NeuroStar® Advanced Therapy System, is a non-invasive and non-systemic office-based treatment that uses transcranial magnetic stimulation, or TMS, to create a pulsed, MRI-strength magnetic field that induces electrical currents designed to stimulate specific areas of the brain associated with mood. The system is cleared by the United States Food and Drug Administration, or FDA, for the treatment of major depressive disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. NeuroStar is also available in other parts of the world, including Japan, where it is listed under Japan’s national health insurance. Additional information can be found at www.neuronetics.com.

Investor Contact:

Mark R. Klausner
Westwicke Partners
443-213-0501
[email protected]

Media Contact:

Chelsey Manko
Vault Communications
610-455-2778
[email protected]

CTG Provides Update on Proven Solutions Strategy Driving Earnings Growth and Shareholder Value

Strong 2020 Third Quarter Growth in Solutions and Earnings Amidst Global Pandemic

Director Search Initiated to Replace Retiring Board Member

BUFFALO, N.Y., Nov. 12, 2020 (GLOBE NEWSWIRE) — CTG (NASDAQ: CTG), a leading provider of information technology (IT) solutions and services in North America and Western Europe, today provided an update regarding the ongoing successful acceleration of its strategic digital solutions plan and commitment to enhancing shareholder value, highlighting the actions the CTG Board of Directors and management team have taken in recent years to expand its solutions business.

Digital Solutions
Strategic Plan

A key objective of the Company’s strategy is to provide higher-margin digital solutions that support long-term growth in all of the markets and industries the Company serves. To do so, the Company will continue to invest its capital to drive additional digital solutions development and to make highly selective, strategic acquisitions that expand and support CTG’s solutions portfolio.

The Company’s existing portfolio of digital solutions include application development and support, infrastructure and data management, and testing and automation services provided to its industries and markets in North America and Europe. These projects range from digital workspace and collaboration platforms to hybrid cloud transformation services, and incorporating robotic process automation (RPA) and artificial intelligence (AI) into service desk offerings. The onset of the global COVID-19 pandemic has accelerated clients’ need for digital transformation services. To support this evolving demand, the Company has strategically invested in its business development resources to focus on selling digital solutions.

CTG has also taken steps to meaningfully strengthen its digital solutions leadership team, ensuring it has the right talent and experience to advance and expand its solutions portfolio. Brett Hunt, Managing Director North American Solutions, whose extensive background includes security solutions and cloud software development, and Tanya Johnson, Managing Director North American Solutions, an application testing and training expert, joined the Company in the past year. Most recently CTG hired Phaedra Divras, Director, North American Solutions, an accomplished executive with experience delivering cloud transformation consulting and managed services. Brett, Tanya and Phaedra, join an increasingly strong global solutions leadership team that also includes Rick Cruz, Director, North American Solutions who has a robust track record in data migration and information management. This team is focused on working closely with the business development teams to accelerate the growth of digital solutions and services across North America and Europe.

“By continuing to execute on our proven solutions strategy and identify new opportunities to expand our digital expertise, we are confident CTG will remain well-positioned to generate long-term, above market growth and deliver higher margins and profitability,” said Filip Gydé, CTG President and CEO.

Mergers and Acquisitions

In addition to strengthening its organic business development initiatives, the Company employs a proven mergers and acquisitions strategy of targeted acquisitions that enhance existing or provide new capabilities, and grow the client base. Since the beginning of 2018, CTG has successfully completed three accretive transactions that added higher-margin offerings to its portfolio, including business consulting in the financial services industry, cloud services and crowd testing. These acquisitions bolster our European operations and supplement a strong and growing organic business that has had significant growth over the past decade. Given the success of these recent acquisitions, the Board and senior leadership team expect to continue evaluating opportunities that will accelerate the delivery of digital services to clients.

Recent Financial Results

Although CTG’s clients and geographic markets have been negatively impacted by the COVID-19 pandemic, the actions the Board and senior leadership team have taken are delivering strong results. In the third quarter of 2020, revenue from solutions services increased 3.7% sequentially and 6.5% year-over-year, and now represent nearly 40% of total revenue. In addition, CTG delivered year-over-year increases in its GAAP operating margin and meaningfully increased adjusted EBITDA to $14.9 million over the last twelve months. This strong quarterly performance builds on CTG’s track record of consistently delivering results and steady improvement over the last seven quarters. During this period, the GAAP operating margin has improved – up 77% from 1.2% in the first quarter of 2019 to 2.1% in the third quarter of 2020. The non-GAAP operating margin increased 72% from 1.5% to 2.7% over the same time period.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/f2173fd9-b88e-4c79-96e4-8f4eb20deb7d

Board Refreshment

CTG’s Board is overseeing senior management’s execution of the Company’s strategic plan. The Board consists of highly qualified individuals who bring extensive talent across IT services, cyber-security, finance and the healthcare sectors to provide strong, unified leadership to the Company. To ensure the Board continues to have the right talent to lead the Company, the Nominating and Corporate Governance Committee has engaged a leading search firm to identify a new independent director as Dan Sullivan, the current Chairman, will leave the Board at the 2021 annual meeting as a result of reaching the Company’s mandatory retirement age. Extensive experience leading digital transformation services will be one of the key criteria that the Board uses to evaluate candidates for the new independent director position.

About CTG

CTG has established a reputation for responsiveness and reliability—traits that our clients say set us apart—since our founding in 1966. Today, we provide comprehensive information, technology, and business solutions that address critical challenges for clients in high-growth industries in North America and Western Europe. Backed by a proven track record of reliable delivery, CTG fosters long-term client relationships and trust, which allows us to develop strategic insights that maximize client investments in solutions and competitive advantage. CTG has operations in North America, South America, Western Europe, and India. The Company regularly posts news and other important information online at www.ctg.com.

Reconciliation of GAAP to Non-GAAP Information

The Company has referenced non-GAAP information in this news release. The Company believes that the use of non-GAAP financial information provides useful information to investors and management to gain an overall understanding of its current financial performance and prospects. In addition, non-GAAP financial measures are used by management for forecasting, facilitating ongoing operating decisions, and measuring the Company’s overall performance. The Company believes that these non-GAAP measures align closely with its internal measurement processes and are reflective of the Company’s core operating results.

A reconciliation of GAAP to non-GAAP information is included in the financial tables below. The non-GAAP financial information is presented using a consistent methodology from quarter-to-quarter and year-to-year. These measures should be considered in addition to results prepared in accordance with GAAP. In addition, these non-GAAP financial measures are not based on any comprehensive set of accounting rules or principles. The Company believes that non-GAAP financial measures have limitations in that they do not reflect all amounts associated with the Company’s results of operations as determined in accordance with GAAP and that these measures should only be used to evaluate the Company’s results of operations in conjunction with the corresponding GAAP financial measures. As such, the non-GAAP financial measures disclosed by the Company should not be considered a substitute for or superior to financial measures calculated in accordance with GAAP, and reconciliations between GAAP and non-GAAP financial measures included in this earnings release should be carefully evaluated.

Safe Harbor Statement

This document contains certain forward-looking statements concerning the Company’s current expectations as to future growth, financial outlook, business strategy and performance expectations for 2020 and statements related to cost control, new business opportunities, financial performance, market demand, and other attributes of the Company. These statements are based upon the Company’s expectations and assumptions, a review of industry reports, current business conditions in the areas where the Company does business, feedback from existing and potential new clients, a review of current and proposed legislation and governmental regulations that may affect the Company and/or its clients, and other future events or circumstances. Actual results could differ materially from the outlook guidance, expectations, and other forward-looking statements as a result of a number of factors, including among others, the effects of the COVID-19 pandemic and the regulatory, social and business responses thereto on the Company’s business, operations, employees, contractors and clients, the availability to the Company of qualified professional staff, domestic and foreign industry competition for clients and talent, increased bargaining power of large clients, the Company’s ability to protect confidential client data, the partial or complete loss of the revenue the Company generates from International Business Machines Corporation (IBM), the ability to integrate businesses when acquired and retain their clients while achieving cost reduction targets, the uncertainty of clients’ implementations of cost reduction projects, the effect of healthcare reform and initiatives, the mix of work between staffing and solutions, currency exchange risks, risks associated with operating in foreign jurisdictions, renegotiations, nullification, or breaches of contracts with clients, vendors, subcontractors or other parties, the change in valuation of capitalized software balances, the impact of current and future laws and government regulation, as well as repeal or modification of such, affecting the information technology (IT) solutions and staffing industry, taxes and the Company’s operations in particular, industry and economic conditions, including fluctuations in demand for IT services, consolidation among the Company’s competitors or clients, the need to supplement or change our IT services in response to new offerings in the industry or changes in client requirements for IT products and solutions, actions of activist shareholders, and other factors that involve risk and uncertainty including those listed in the Company’s reports filed with the Securities and Exchange Commission as of the date of this document. Such forward-looking statements should be read in conjunction with the Company’s disclosures set forth in the Company’s Form 10-K for the year ended December 31, 2019, which is incorporated by reference, and other reports that may be filed from time to time with the Securities and Exchange Commission. The Company assumes no obligation to update the forward-looking information contained in this release.

Contacts

Investors:
John M. Laubacker, Chief Financial Officer
(716) 887-7368

Media
Michael Freitag / Joseph Sala
Joele Frank, Wilkinson Brimmer Katcher
(212) 355-4449

COMPUTER TASK GROUP, INCORPORATED (CTG)

(Unaudited)

The non-GAAP information below excludes gains from non-taxable life insurance and on the sale of a building, and costs associated with severance and certain acquisition-related expenses. The acquisition-related expenses consist of due diligence costs, amortization of intangible assets, and changes in the value of earn-out payments upon the achievement of certain financial targets from the Company’s recent acquisitions.

Reconciliation of GAAP to non-GAAP Operating Margin

  For the Quarter Ended
  Mar.   Jun.   Sept.   Dec.   Mar.   Jun.   Sept.
  2019   2019   2019   2019   2020   2020   2020
GAAP Operating Margin 1.2 %   1.8 %   1.6 %   2.4 %   2.4 %   2.1 %   2.1 %
Acquisition-related expenses 0.3 %   0.6 %   0.8 %   0.6 %   0.5 %   0.4 %   0.6 %
Severance                     0.7 %    
Non-GAAP Operating Margin 1.5 %   2.4 %   2.4 %   3.0 %   2.9 %   3.2 %   2.7 %
                           

Reconciliation of Net income to Earnings before Interest, Taxes, Depreciation and Amortization, Equity-Based Compensation, Non-Operational Gains on Life Insurance and Sale of a Building, Acquisition-Related Expenses and adjusted EBITDA

  For the Quarter Ended
  Mar.   Jun.   Sept.   Dec.   Mar.   Jun.   Sept.

(in millions)
2019   2019   2019   2019   2020   2020   2020
Net income*** $ 0.6   $ 0.9   $ 0.9   $ 1.7   $ 1.1   $ 1.8     $ 2.8  
Interest   0.1     0.1     0.1     0.1     0.1            
Taxes   0.3     0.6     0.4     0.8     0.7     1.4       (0.6 )
Depreciation and amortization   0.7     0.7     1.0     0.8     0.8     0.8       1.0  
Equity-Based compensation expense   0.2     0.5     0.5     0.6     0.5     0.6       0.7  
Severance                       0.6        
Non-taxable life insurance gain                       (0.4 )     (0.6 )
Gain on sale of building                       (0.8 )      
Acquisition-related expenses   0.2     0.2     0.2     0.2     0.2            
Adjusted EBITDA $ 2.1   $ 3.0   $ 3.1   $ 4.2   $ 3.4   $ 4.0     $ 3.3  
                           

*** Net Income in the 2020 third quarter includes a $1.1 million tax benefit from a change in legislation

C4 Therapeutics Reports Business Highlights and Third Quarter 2020 Financial Results

Strengthened leadership team with appointments of Andrew Hirsch as Chief Executive Officer, William McKee as Chief Financial Officer and Jolie M. Siegel as Chief Legal Officer

Completed upsized IPO in October 2020, raising $209.8 million in gross proceeds; cash runway extended into the second half of 2023

Investigational New Drug (IND) submission for lead candidate, CFT7455, for hematologic malignancies anticipated by YE 2020; Phase 1/2 study expected to initiate in 1H 2021

WATERTOWN, Mass., Nov. 12, 2020 (GLOBE NEWSWIRE) — C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a biopharmaceutical company pioneering a new class of small-molecule drugs that selectively destroys disease-causing proteins through degradation, today reported financial results for the third quarter ended September 30, 2020, highlighted recent progress and provided a business update.

“C4T’s recent IPO was a tremendous milestone for our team and an important accomplishment as the company advances our programs to the clinic. With a strong balance sheet and expanded senior team, we are well-positioned to execute against our pipeline and continue investing in our differentiated TORPEDO™ discovery platform,” said Andrew Hirsch, chief executive officer at C4 Therapeutics. “Looking ahead, we expect to have four clinical-stage programs by the end of 2022, including our lead candidate, CFT7455, for hematological malignancies, which is on track for an IND submission by the end of this year. We believe targeted protein degraders represent a novel class of medicines with distinctive benefits over traditional inhibitor drugs and look forward to exploring their potential in patients.”

THIRD QUARTER 2020 AND RECENT HIGHLIGHTS

  • Amended the Amended and Restated Roche Collaboration Agreement: In November 2020, C4T entered into the First Amendment to its 2018 Amended and Restated License Agreement with F. Hoffman-La Roche Ltd and Hoffman-La Roche Inc., which clarifies the rights and responsibilities of both parties in the event of a program termination. In addition, through this amendment, C4T and Roche mutually agreed to terminate the Amended and Restated Agreement with respect to the target epidermal growth factor receptor (EGFR). With this termination, C4T regains the right to pursue the target EGFR in products that use degradation as their mode of action.
  • Presented at Scientific Conferences on Protein Structure and Degradation: In October 2020, C4T participated in the 3rd Annual Targeted Protein Degradation Summit. Rhamy Zeid, Ph.D., Director of Target Biology at C4T, delivered a presentation highlighting CFT8634, a novel degrader of the protein BRD9. This case study showcased C4T’s TORPEDO platform’s capabilities to enable the development of novel, selective, orally bioavailable degraders. C4T’s Chief Scientific Officer, Stewart Fisher, Ph.D., also led a roundtable discussion on the pace of innovation in drug discovery and development. In November 2020, C4T participated in the 28th Annual Protein Structure Determination in Industry (PSDI) Conference. Joe Patel, Ph.D., C4T’s Senior Director of Biochemistry, Biophysics and Crystallography, delivered a presentation demonstrating how C4T’s TORPEDO platform leverages HDX data and computational methods to design novel degrader candidates with predictable ternary complexes.
  • Completed Upsized Initial Public Offering: In October 2020, C4T completed an upsized initial public offering of 11.0 million shares of common stock, including the full exercise of the underwriters’ over-allotment option, at a price of $19.00 per share. Net proceeds from the offering were $191.1 million.
  • Strengthened Leadership Team: In September 2020, C4T announced the appointment of Andrew Hirsch as Chief Executive Officer. Additionally, in July 2020, the Company announced the appointments of William McKee as Chief Financial Officer and Jolie M. Siegel as Chief Legal Officer.

KEY UPCOMING MILESTONES

  • Investigational New Drug (IND) submission planned for Q4 2020 for CFT7455, an orally bioavailable MonoDAC™ (Monofunctional Degradation Activating Compound) targeting IKZF1/3 for the treatment of hematologic malignancies such as multiple myeloma and non-Hodgkin lymphomas (NHLs), including peripheral T cell lymphoma (PTCL) and mantle cell lymphoma (MCL). C4T anticipates initiating a Phase 1/2 clinical trial for this program in 1H 2021.
  • IND submission expected in 2H 2021 for CFT8634, an orally bioavailable BiDAC™ (Bifunctional Degradation Activating Compound) targeting BRD9 for the treatment of synovial sarcoma and SMARCB1-deleted solid tumors. C4T anticipates initiating a Phase 1/2 clinical trial for this program by 2H 2021.

UPCOMING INVESTOR EVENTS

  • November 19, 2020 – C4T will present at the Jefferies Virtual London Healthcare Conference
  • December 3, 2020 – C4T will hold a Fireside Chat/Panel discussion at the 3rd Annual Evercore ISI HealthCONx Conference

THIRD QUARTER 2020 FINANCIAL RESULTS

Revenues: Total revenues for the third quarter of 2020 were $8.4 million, compared to $5.4 million for the third quarter of 2019. Total revenues reflect revenues recognized under our collaboration agreements with Roche, Biogen and Calico and increased by $3 million compared to the same period of 2019 primarily due to increased reimbursements from Biogen reflecting increase activities on collaboration projects and related activities.

Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2020 were $23.9 million, compared to $12.9 million for the third quarter of 2019. The increase in R&D expense was primarily attributable to increased third-party chemistry and biology costs, higher preclinical costs related to our lead programs and increased workforce expenses to support our growing clinical development activities.

General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2020 were $2.9 million, compared to $2.4 million for the third quarter of 2019. The increase in G&A expense was primarily attributable to higher legal and professional costs supporting the company’s growth.

Net Loss: Net loss for the third quarter of 2020 was $21.8 million, compared to $10.1 million for the third quarter of 2019.

Cash Position and Financial Guidance: Cash, cash equivalents and short-term investments as of September 30, 2020, were $199.4 million, compared to $90.5 million as of December 31, 2019. The September 30th balance does not include $191.1 million in net proceeds from our initial public offering, which was completed on October 6, 2020. We expect our cash, cash equivalents and short-term investments, including the net proceeds from our initial public offering and payments to be received under our existing collaboration agreements, will be sufficient to fund planned operating expenses and capital expenditures into the second half of 2023.

About C4 Therapeutics

C4 Therapeutics (C4T) is a biopharmaceutical company focused on harnessing the body’s natural regulation of protein levels to develop novel therapeutic candidates to target and destroy disease-causing proteins for the treatment of cancer, neurodegenerative conditions and other diseases. This targeted protein degradation approach offers advantages over traditional therapies, including the potential to treat a wider range of diseases, reduce drug resistance, achieve higher potency, and decrease side effects through greater selectivity. To learn more about C4 Therapeutics, visit www.C4Therapeutics.com.

Forward-Looking Statements

This press release contains “forward-looking statements” of C4 Therapeutics, Inc. within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, express or implied statements regarding our ability to develop potential therapies for patients; the design and potential efficacy of our therapeutic approaches; the predictive capability of our TORPEDO™ platform in the development of novel, selective, orally bioavailable degraders; the potential timing and advancement of our preclinical studies and clinical trials; our ability and the potential to successfully manufacture and supply our product candidates for clinical trials; our ability to replicate results achieved in our preclinical studies or clinical trials in any future studies or trials; our current resources and cash runway; and regulatory developments in the United States and foreign countries. Any forward-looking statements in this press release are based on management’s current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: uncertainties related to the initiation, timing and conduct of studies and other development requirements for our product candidates; the risk that any one or more of our product candidates will not be successfully developed and commercialized; and the risk that the results of preclinical studies and clinical trials will be predictive of future results in connection with future studies or trials. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause C4T’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in C4 Therapeutics registration statement on Form S-1, as filed with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and C4T undertakes no duty to update this information unless required by law.

         
Consolidated Balance Sheet Data
(in thousands)
(Unaudited)
    SEPTEMBER 30,
2020
  DECEMBER 31,
2019
Cash, cash equivalents and short-term investments   $ 199,413     $ 90,549  
Accounts Receivable     4,141       4,623  
Total Assets     229,127       118,260  
Deferred Revenue     84,997       93,423  
Debt     9,877        
Stockholders’ Deficit     (155,924 )     (111,963 )
         

 

                 
Consolidated Statement of Operations Data
(in thousands, except share and per share data)
(Unaudited)
                 
    THREE MONTHS ENDED
SEPTEMBER 30,
  NINE MONTHS ENDED
SEPTEMBER 30,
      2020       2019       2020       2019  
Revenue from collaboration agreements   $ 8,447     $ 5,364     $ 24,933     $ 13,172  
Operating expenses:                
Research and development     23,935       12,948       58,007       32,042  
General and administrative     2,861       2,417       8,472       6,083  
Total operating expenses     26,796       15,365       66,479       38,125  
Loss from operations     (18,349 )     (10,001 )     (41,546 )     (24,953 )
Net loss     (21,835 )     (10,094 )     (44,540 )     (24,076 )
Accrual of preferred stock dividends     (5,212 )     (2,201 )     (10,363 )     (6,531 )
Net loss attributable to common stockholders     (27,047 )     (12,295 )     (54,903 )     (30,607 )
Net loss per share – basic and diluted   $ (17.55 )   $ (8.93 )   $ (36.76 )   $ (22.59 )
Weighted-average number of shares used in computing net loss per share – basic and diluted     1,540,902       1,376,365       1,493,521       1,354,734  
                 

Investor & Media Contact:
Kendra Adams
SVP, Communications & Investor Relations
[email protected]

aTyr Pharma Announces Third Quarter 2020 Results and Provides Corporate Update

C
omplete
s
e
nrollment of ATYR1923
c
linical
t
rial
in
patients with
COVID-19
s
evere
r
espiratory
c
omplications
.
Topline
data is expected at turn of calendar year.

Announce
s
Investigational New Drug
c
andidate
in oncology,
ATYR2810
,
f
rom its NRP2
a
ntibody
p
rogram
.

Company to host conference call and webcast today,
November 12,
at 5:00 p.m. E
S
T / 2:00 p.m. P
S
T
.

SAN DIEGO, Nov. 12, 2020 (GLOBE NEWSWIRE) — aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, today announced third quarter results and provided a corporate update.

“Throughout the third quarter, we remained focused on our clinical program for our lead therapeutic candidate, ATYR1923. We now have three active clinical trials as part of this program. Most notably, we have completed enrollment in our Phase 2 trial in COVID-19 patients with severe respiratory complications. We expect to report topline data from this study around the turn of the calendar year. In addition, amidst the ongoing pandemic, our pulmonary sarcoidosis trial sites have been reactivated to screen and dose patients and finish enrollment of the third and final cohort of our Phase 1b/2a study. Finally, our partner Kyorin Pharmaceutical is currently enrolling a Phase 1 study in healthy volunteers in Japan,” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr.

“While our clinical operations have expanded, so too has our pipeline. We have selected an Investigational New Drug (IND) candidate from our Neuropilin-2 (NRP2) antibody program, ATYR2810. This antibody, which has generated compelling data in pre-clinical cancer models, will be evaluated for the potential treatment of certain aggressive tumors where NRP2 is implicated.”

Third Quarter 2020 and Subsequent Period Highlights

  • Completed enrollment in its Phase 2 randomized, double blind, placebo-controlled study of ATYR1923 in COVID-19 patients with severe respiratory complications. The study enrolled a total of 32 patients at hospitals in the U.S. and Puerto Rico, exceeding the target enrollment of 30 patients. Topline data is expected at the turn of the calendar year.
  • Continued enrollment in the third and final cohort of its ongoing Phase 1b/2a multiple-ascending dose, placebo-controlled study of ATYR1923 in 36 patients with pulmonary sarcoidosis. The majority of sites have reactivated and are screening and dosing patients.
  • Kyorin Pharmaceutical, Co., Ltd., aTyr’s partner in the development and commercialization of ATYR1923 for interstitial lung diseases in Japan, initiated and continues to enroll a Phase 1 study to evaluate the safety, pharmacokinetics and immunogenicity of ATYR1923 (known as KRP-R120 in Japan) in 32 Japanese healthy volunteers.
  • Declared an IND candidate in oncology from its NRP2 antibody program, ATYR2810. This fully humanized monoclonal antibody will be evaluated for the potential treatment of certain aggressive tumors where NRP2 is implicated. NRP2 expression is associated with worsened patient outcomes in many cancers.
  • Entered into a research collaboration with the Medical University of South Carolina (MUSC) to support the company’s NRP2 antibody program in oncology. Dr. Robert Gemmill, the former Melvyn Berlinksy Chair of Cancer Research and Professor of Medicine Emeritus in the Division of Hematology/Oncology at MUSC, will serve as the principal investigator for the collaboration, which aims to accelerate the development of therapeutic antibodies that selectively target specific NRP2 isoforms and validate their potential use in the treatment of lung cancer.
  • Published a paper in the peer-reviewed journal mAbs titled, “Isolation of monoclonal antibodies from anti-synthetase syndrome patients and affinity maturation by recombination of independent somatic variants,” which highlighted novel technological advances to isolate, characterize and engineer high-affinity therapeutic antibodies.

Third Quarter 2020 Financial Results

Total revenues were $0.1 million and $0.2 million for the three months ended September 30, 2020 and 2019, respectively, consisting of license revenue. Research and development expenses were $4.6 million and $3.8 million for the three months ended September 30, 2020 and 2019, respectively. The increase was due primarily to the progression of ATYR1923 clinical activities. General and administrative expenses were consistent between the periods at $2.0 million and $1.9 million for the three months ended September 30, 2020 and 2019, respectively.

Total revenues were $8.4 million and $0.3 million for the nine months ended September 30, 2020 and 2019, respectively. Revenues for the nine months ended September 30, 2020 included $8.0 million from license revenue under the collaboration agreement with Kyorin. Research and development expenses were $12.6 million and $10.5 million for the nine months ended September 30, 2020 and 2019, respectively. The increase was due primarily to the progression of ATYR1923 clinical activities. General and administrative expenses were consistent between the periods at $6.8 million for each of the nine months ended September 30, 2020 and 2019.

As of September 30, 2020, aTyr had $36.1 million in cash, cash equivalents and investments. As of September 30, 2020, aTyr had $3.1 million of term loans. On November 3, 2020, aTyr fully repaid its term loans and retired its debt.

Conference Call and Webcast Details

aTyr Pharma will host a conference call and webcast today at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time to discuss its financial results and provide a corporate update. Interested parties may access the call by dialing toll-free 844-358-9116 from the US, or 209-905-5951 internationally and using conference ID 4549288. Links to a live audio webcast and replay may be accessed on the aTyr website events page at: http://investors.atyrpharma.com/events-and-webcasts. An audio replay will be available for at least 90 days following the event.

About ATYR1923

aTyr is developing ATYR1923 as a potential therapeutic for patients with inflammatory lung diseases. ATYR1923, a fusion protein comprised of the immuno-modulatory domain of histidyl tRNA synthetase fused to the FC region of a human antibody, is a selective modulator of neuropilin-2 that downregulates the innate and adaptive immune response in inflammatory disease states. aTyr is currently enrolling a proof-of-concept Phase 1b/2a trial evaluating ATYR1923 in patients with pulmonary sarcoidosis. This Phase 1b/2a study is a multi-ascending dose, placebo-controlled, first-in-patient study of ATYR1923 that has been designed to evaluate the safety, tolerability, steroid sparing effect, immunogenicity and pharmacokinetics profile of multiple doses of ATYR1923. In response to the COVID-19 pandemic, aTyr is conducting a Phase 2 clinical trial with ATYR1923 in COVID-19 patients with severe respiratory complications. This Phase 2 study is a randomized, double blind, placebo-controlled study that has been designed to evaluate the safety and preliminary efficacy of a single dose of ATYR1923.

About aTyr

aTyr is a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways. aTyr’s research and development efforts are concentrated on a newly discovered area of biology, the extracellular functionality and signaling pathways of tRNA synthetases. aTyr has built a global intellectual property estate directed to a potential pipeline of protein compositions derived from 20 tRNA synthetase genes and their extracellular targets. aTyr’s primary focus is ATYR1923, a clinical-stage product candidate which binds to the neuropilin-2 receptor and is designed to down-regulate immune engagement in inflammatory lung diseases. For more information, please visit http://www.atyrpharma.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by such safe harbor provisions for forward-looking statements and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements include statements regarding the potential therapeutic benefits and applications of ATYR1923, ATYR2810 and our NRP2 antibody program; timelines and plans with respect to certain development activities (including the further development of ATYR9123, ATYR2810 and our NRP2 antibody program); expected activities under our collaboration agreements and certain development goals. These forward-looking statements also reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects, as reflected in or suggested by these forward-looking statements, are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. All forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain. Furthermore, actual results may differ materially from those described in these forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, the fact that NRP2 biology is not fully understood, uncertainty regarding the COVID-19 pandemic, including the risk of delays in enrollment in our clinical trials, risks associated with the discovery, development and regulation of our product candidates, including the risk that results from clinical trials or other studies may not support further development, the risk that we may cease or delay preclinical or clinical development activities for any of our existing or future product candidates for a variety of reasons, the fact that our collaboration agreements are subject to early termination, and the risk that we may not be able to raise the additional funding required for our business and product development plans, as well as those risks set forth in our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and in our other SEC filings. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

   
ATYR PHARMA INC.  
Condensed Consolidated Statements of Operations  
(in thousands, except share and per share data)  
           
  Three Months Ended     Nine Months Ended  
  September
 
30,
    September
 
30,
 
  2020     2019     2020     2019  
                       
  (unaudited)  
Revenues:                              
License revenues $ 148     $ 184     $ 8,402     $ 278  
Total revenues   148       184       8,402       278  
Operating expenses:                              
Research and development   4,616       3,799       12,593       10,458  
General and administrative   2,044       1,883       6,780       6,836  
Total operating expenses   6,660       5,682       19,373       17,294  
Loss from operations   (6,512 )     (5,498 )     (10,971 )     (17,016 )
Total other expense, net   (88 )     (147 )     (324 )     (614 )
Consolidated net loss $ (6,600 )   $ (5,645 )   $ (11,295 )   $ (17,630 )
Net loss attributable to noncontrolling interest in Pangu BioPharma Limited   1             3        
Net loss attributable to aTyr Pharma, Inc. $ (6,599 )   $ (5,645 )   $ (11,292 )   $ (17,630 )
Net loss per share, basic and diluted $ (0.68 )   $ (1.47 )   $ (1.31 )   $ (5.55 )
Shares used in computing net loss per share, basic and diluted   9,648,534       3,846,249       8,632,972       3,175,177  

   
ATYR PHARMA INC.  
Condensed Consolidated Balance Sheets  
(in thousands)  
               
  September
 
30,
    December
 
31,
 
  2020     2019  
  (unaudited)          
Cash, cash equivalents and available-for-sale investments $ 36,146     $ 31,144  
Other receivables   245       100  
Property and equipment, net   1,004       1,270  
Right-of-use assets   2,274       2,821  
Prepaid expenses and other assets   1,967       853  
Total assets $ 41,636     $ 36,188  
               
Accounts payable, accrued expenses and other liabilities $ 4,138     $ 3,431  
Current portion of operating lease liability   834       755  
Term loans, net of debt issuance costs and discount   3,061       8,737  
Long-term operating lease liability, net of current portion   1,605       2,239  
Total Stockholders’ equity   31,998       21,026  
Total liabilities and stockholders’ equity $ 41,636     $ 36,188  

 
Contact:
Ashlee Dunston
Director, Investor Relations and Corporate Communications


[email protected]