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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

 

Date of Report (Date of earliest event reported): August 9, 2021

 

SENSEONICS HOLDINGS, INC.
(Exact Name of Registrant as Specified in its Charter)

 

Delaware   001-37717   47-1210911
(State or Other
Jurisdiction of Incorporation)
  (Commission File Number)   (IRS Employer
Identification No.)

 

20451 Seneca Meadows Parkway
Germantown, MD 20876-7005
(Address of Principal Executive Office) (Zip Code)

 

Registrant's telephone number, including area code: (301) 515-7260

 

Not Applicable

Former name or former address, if changed since last report

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2 below):

 

¨    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class Trading Symbol(s) Name of each exchange on which registered
Common Stock SENS NYSE American

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

 

 

 

 

Item 2.02. Results of Operations and Financial Condition.

 

On August 9, 2021, Senseonics Holdings, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2021, as well as information regarding a conference call to discuss these financial results and the Company’s recent corporate highlights and outlook. This press release and a transcript of the conference call are furnished as Exhibits 99.1 and 99.2, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.

 

The information in this Current Report on Form 8-K, including Exhibits 99.1 and 99.2 attached hereto, are furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section. The information contained herein and in the accompanying exhibits are not incorporated by reference in any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof and irrespective of any general incorporation language in any filings.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit    
Number   Description
99.1   Press Release of Senseonics Holdings, Inc. dated August 9, 2021.
99.2   Transcript of Senseonics Earnings Call held on August 9, 2021.
104   Cover Page Interactive Data (embedded within the Inline XBRL document).

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: August 11, 2021 SENSEONICS HOLDINGS, INC.
     
  By: /s/ Nick Tressler
  Name: Nick Tressler
  Title: Chief Financial Officer

 

 

 

 

Exhibit 99.1

 

 

 

SENSEONICS HOLDINGS, INC. REPORTS SECOND QUARTER 2021 FINANCIAL RESULTS

 

GERMANTOWN, MD, August 9, 2021 —Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and commercialization of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today reported financial results for the quarter ended June 30, 2021.

 

Recent Highlights & Accomplishments:

 

·Generated second quarter 2021 revenue of $3.3 million.
·Ascensia Diabetes Care launched both a U.S. patient assistance program, reducing out-of-pocket costs to support all diabetes patients including the 200 million covered lives, and a direct-to-consumer digital advertising campaign, to raise patient awareness of Eversense and generate new patient leads.
·“The PROMISE Study: An Evaluation of the Safety and Accuracy of the Next Generation 180-Day Long-term Implantable Eversense CGM System” demonstrating sensor accuracy MARD of 8.5-9.1% was presented in June at the ATTD and ADA conferences along with the submission of the manuscript to a major diabetes journal.
·FDA active review continues for the Eversense® 180-day PMA supplement application.
·Raised $50 million in gross proceeds through completion of At-the-Market equity offering program. The use of proceeds is intended primarily for debt service.

 

“In the second quarter we made progress driving increased patient and provider awareness of Eversense through a targeted direct-to-consumer digital advertising campaign and presentations of the PROMISE Study, an evaluation of our 180-day sensor, at the ADA and ATTD conferences,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. “As announced when we submitted this data to the FDA, we are pleased with the strength of the data from the PROMISE Study which we believe represents a top tier CGM safety and accuracy profile. Along with our commercial partner Ascensia Diabetes Care we are excited about the opportunity to offer more patients the longest lasting CGM systems.”

 

Second Quarter 2021 Results:

 

Total revenue for the quarter was $3.29 million compared to $0.26 million for the second quarter of 2020. U.S. revenue was $0.98 million and revenue outside the U.S. was $2.31 million.

 

Second quarter 2021 gross profit increased by $1.54 million year-over-year, to $0.39 million. The positive gross margin in the quarter was primarily due to the fulfillment of orders utilizing existing written off inventory as a result of the COVID-19 pandemic.

 

Second quarter 2021 sales and marketing expenses decreased by $1.50 million year-over-year, to $1.64 million. The decrease was primarily due to the strategic changes in our go-to-market strategy with the Ascensia global collaboration.

 

Second quarter 2021 research and development expenses increased by $3.31 million year-over-year, to $7.11 million. The increase was primarily driven by clinical study costs and primarily non-cash, stock-based compensation and other personnel related expenses.

 

Second quarter 2021 general and administrative expenses increased by $3.09 million year-over-year, to $7.53 million. The increase was primarily due to primarily non-cash, stock-based compensation and other personnel related costs.

 

Net loss was $180.32 million, or $0.42 per share, in the second quarter of 2021, compared to $7.52 million, or $0.03 per share, in the second quarter of 2020. Net loss increased by $172.81 million due to a $169.43 million increase in other expenses primarily related to non-cash accounting charges resulting from the accounting for embedded derivatives related to certain of the company financings, as well as a $3.36 million increase in loss from operations.

 

 

 

 

 

 

As of June 30, 2021, cash, cash equivalents, short and long-term investments were $215.0 million and outstanding indebtedness was $109.9 million.

 

2021 Financial Outlook

 

The company continues to expect that global net revenue to Senseonics for the full year 2021 will be in the range of $12.0 million to $15.0 million.

 

Conference Call and Webcast Information:

 

Company management will host a conference call at 4:30 pm (Eastern Time) today, August 9, 2021, to discuss these financial results and recent business developments. This conference call can be accessed live by telephone or through Senseonics’ website.

 

Live Teleconference Information:

Dial in number: 888-317-6003

Entry Number: 4998185

International dial in: 412-317-6061

Live Webcast Information:

Visit http://www.senseonics.com and select the “Investor Relations” section

 

A replay of the call can be accessed on Senseonics’ website http://www.senseonics.com under “Investor Relations.”

 

About Senseonics

 

Senseonics Holdings, Inc. is a medical technology company focused on the design, development and commercialization of transformational glucose monitoring products designed to help people with diabetes confidently live their lives with ease. Senseonics' CGM systems, Eversense® and Eversense® XL, include a small sensor inserted completely under the skin that communicates with a smart transmitter worn over the sensor. The glucose data are automatically sent every 5 minutes to a mobile app on the user's smartphone.

 

Forward Looking Statements

 

Any statements in this press release about future expectations, plans and prospects for Senseonics, including the revenue projections under “2021 Financial Outlook,” statements about the potential benefits of the Ascensia commercialization and collaboration agreement, including the ability of Ascensia to grow the market for Eversense, the future increase in patient and provider awareness of Eversense, reductions in patient costs and expansion of access to Eversense, and other statements containing the words “believe,” “expect,” “intend,” “may,” “projects,” “will,” “planned,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties in the development and regulatory approval processes for the 180-day Eversense product, uncertainties inherent in the commercial launch and commercial expansion of the product, uncertainties inherent in the transition of commercialization responsibilities to Ascensia, uncertainties in insurer, regulatory and administrative processes and decisions, uncertainties in the duration and severity of the COVID-19 pandemic, and such other factors as are set forth in the risk factors detailed in Senseonics’ Annual Report on Form 10-K for the year ended December 31, 2020, Senseonics’ Quarterly Report on Form 10-Q for the quarter ended March 31, 2021 and Senseonics’ other filings with the SEC under the heading “Risk Factors.” In addition, the forward-looking statements included in this press release represent Senseonics’ views as of the date hereof. Senseonics anticipates that subsequent events and developments will cause Senseonics’ views to change. However, while Senseonics may elect to update these forward-looking statements at some point in the future, Senseonics specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing Senseonics’ views as of any date subsequent to the date hereof.

 

 

 

 

 

 

Investor Contact

Lynn Lewis or Philip Taylor

Investor Relations

415-937-5406

[email protected]

 

Senseonics Media Contact:

Mirasol Panlilio

301-556-1631

 

 

 

 

 

 

Senseonics Holdings, Inc. 

Consolidated Balance Sheets 

(in thousands, except for share and per share data)

 

   June 30,   December 31, 
   2021   2020 
   (unaudited)     
Assets          
Current assets:          
Cash and cash equivalents  $69,754   $18,005 
Restricted cash       200 
Short term investments, net   93,337     
Accounts receivable, net   207    565 
Accounts receivable - related parties   2,584    2,421 
Inventory, net   8,816    5,281 
Prepaid expenses and other current assets   4,533    3,774 
Total current assets   179,231    30,246 
           
Option   723    1,886 
Deposits and other assets   1,861    2,229 
Long term investments, net   51,919     
Property and equipment, net   1,391    1,557 
Total assets  $235,125   $35,918 
           
Liabilities and Stockholders’ Deficit          
Current liabilities:          
Accounts payable  $3,032   $1,762 
Accrued expenses and other current liabilities   11,225    11,674 
Term Loans, net   5,763    3,202 
Total current liabilities   20,020    16,638 
           
Long-term debt and notes payables, net   54,664    57,216 
Derivative liabilities   367,379    62,119 
Option   104,653    39,734 
Other liabilities   1,049    1,483 
Total liabilities   547,765    177,190 
           
Preferred stock and additional paid-in-capital, subject to possible redemption: $0.001 par value per share; 0 shares issued and outstanding as of June 30, 2021 and 3,000 shares issued and outstanding as of December 31, 2020       2,811 
Total temporary equity       2,811 
           
Commitments and contingencies          
           
Stockholders’ deficit:          
Common stock, $0.001 par value per share; 900,000,000 shares authorized; 445,124,690 and 265,582,688 shares issued and outstanding as of June 30, 2021 and December 31, 2020   445    266 
Additional paid-in capital   765,262    504,162 
Accumulated other comprehensive loss, net of tax   (16)    
Accumulated deficit   (1,078,331)   (648,511)
Total stockholders' deficit   (312,640)   (144,083)
Total liabilities and stockholders’ deficit  $235,125   $35,918 

 

 

 

 

 

 

Senseonics Holdings, Inc. 

Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except for share and per share data)

 

   Three Months Ended   Six Months Ended 
   June 30,   June 30, 
   2021   2020   2021   2020 
Revenue, net  $433   $216   $920   $247 
Revenue, net - related parties   2,856    45    5,215    50 
Total revenue   3,289    261    6,135    297 
Cost of sales   2,897    1,404    5,217    21,074 
Gross profit (loss)   392    (1,143)   918    (20,777)
Expenses:                    
Sales and marketing expenses   1,644    3,142    3,257    14,287 
Research and development expenses   7,107    3,796    12,362    11,159 
General and administrative expenses   7,531    4,445    12,505    10,134 
Operating loss   (15,890)   (12,526)   (27,206)   (56,357)
Other (expense) income, net:                    
Interest income   247    8    256    217 
Loss on fair value adjustment of option   (35,730)       (88,405)    
Gain (Loss) on extinguishment of debt and option       (6,385)   330    (10,931)
Interest expense   (4,034)   (3,555)   (8,092)   (7,928)
Gain (Loss) on change in fair value of derivatives   (124,361)   15,238    (305,260)   25,549 
Impairment cost   (381)       (1,163)    
Other expense   (157)   (295)   (280)   (658)
Total other (expense) income, net   (164,416)   5,011    (402,614)   6,249 
Net loss   (180,306)   (7,515)   (429,820)   (50,108)
Other comprehensive loss, net of tax                    
Unrealized loss on marketable securities   (16)       (16)    
Total other comprehensive loss, net of tax   (16)       (16)    
Total comprehensive loss  $(180,322)  $(7,515)  $(429,836)  $(50,108)
                     
Basic and diluted net loss per common share  $(0.42)  $(0.03)  $(1.08)  $(0.24)
Basic and diluted weighted-average shares outstanding   431,840,854    220,305,606    398,244,296    212,025,792 

 

 

 

Exhibit 99.2

 

Senseonics 2Q21 Earnings Script
August 9, 2021

 

Philip Taylor

 

Thank you. This is Philip Taylor from the Gilmartin Group. Before we begin today, let me remind you that the Company's remarks include forward-looking statements. These statements reflect management's expectations about future events, operating plans, regulatory matters, product enhancements, company performance and other matters, and speak only as of the date hereof. These forward-looking statements involve a number of risks and uncertainties. A list of the factors that could cause actual results to be materially different from those expressed or implied by any of these forward-looking statements is detailed under Risk Factors and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2020, our 10-Q for the quarter ended June 30, 2021, and our other reports filed with the SEC. These documents are available in the investor relations section of our website at www.senseonics.com. We undertake no obligation to update publicly or revise these forward-looking statements for any reason except as required by law. Also, on this call we will be discussing our 2021 outlook.

 

Joining me from Senseonics are Tim Goodnow, President and chief executive officer and Nick Tressler, chief financial officer.

 

With that, I would like to turn the call over to Tim Goodnow, President and CEO. Tim?

 

Tim Goodnow

 

Hello and thank you all for joining us. Today we’ll discuss the Q2 commercial initiatives led by of our global partner Ascensia Diabetes Care and provide progress updates on our clinical, product pipeline and regulatory activities. Nick will address the second quarter financials in detail, and then I will conclude and open the call up for Q&A.

 

In the second quarter, Senseonics achieved revenue of $3.3 million, which included $1.0 million of revenue from the U.S., and $2.3 million of revenue from outside the U.S. Through the first half of the year the global commercial partnership integration has progressed to Ascensia taking over full commercial operations and we have collaboratively continued our efforts to minimize the patient base attrition maintaining Eversense users. Based off the current plan, we continue to expect that global net revenue to Senseonics for the full year 2021 will be in the range of $12.0 to $15.0 million dollars.

 

1

 

 

Senseonics 2Q21 Earnings Script
August 9, 2021

 

As we operate today under the terms of our commercial collaboration agreement, Ascensia has assumed responsibility for marketing, market access, sales, distribution, reimbursement, and customer service in the U.S., Germany, Italy, Spain, the Netherlands, Poland, and now Sweden and Norway, the last two existing markets which were transitioned ahead of plan in Q2. We at Senseonics remain focused on product development, including clinical trials and regulatory activities, along with manufacturing our systems.

 

In the U.S., this was the first quarter for most members of Ascensia’s U.S. sales team, and we are pleased that they have taken the steps to establish this market coverage. To support this, they identified the skill sets that are required for sales professionals to be successful introducing our transformative CGM technology. Twenty-five new sales professionals experienced in diabetes or medical technology have now been fully on-boarded and are calling on existing accounts. This team has been trained in the reimbursement landscape and how to introduce the product and procedures to clinicians. The sales professionals are supported by a team of inside sales, clinical trainers, distribution channel, market access and customer care professionals at Ascensia. This comprehensive commercial infrastructure currently enables the targeting of existing providers and their intensively managed patients, as well as the payors and the trade channels. These resources invested by Ascensia represent their strong commitment to Eversense and are supportive of the full commercial activities.

 

Coming out of the height of the pandemic and our very limited commercialization in 2020 to both patients and providers, the Ascensia salesforce is actively reintroducing the product to both clinicians and patients who were impacted by these disruptions, with an initial focus on reestablishing and maintaining relationships. Their first action is calling on the existing Eversense prescribers to introduce themselves, make them aware of the transition and our re-entry into the market in pursuit of servicing existing patients and new patients. This stabilization effort is targeted at rebuilding the foundation for future growth. In the second half of the year, they plan to expand their reach to training and onboarding additional prescriber practices. We know there is real work to be done to regain market traction and we are pleased it is underway.

 

2

 

 

Senseonics 2Q21 Earnings Script
August 9, 2021

 

To support driving growth in the installed base, continuing user retention and ensuring greater access to Eversense, Ascensia has launched a patient assistance program. This program is designed to accommodate those whose health plans have high deductibles, coinsurance or co-pay costs and to support their out-of-pocket costs with using Eversense.

 

Specifically, U.S. Eversense users can access the program which covers up to $300 per sensor after the patient pays the first $100 out-of-pocket. For those who qualify for the full $300 reimbursement per sensor, Eversense would generally have a lower total annual cost than other CGMs on the market. Ascensia estimates that over half of people using mealtime insulin in the U.S. could be eligible for the patient assistance program. While the economics are different from our previous Bridge program, the patient assistance program shares the similar commitment intended to help a broader group with access to Eversense.

 

Ascensia is prioritizing raising awareness of the Eversense system within the diabetes community to drive demand with the patient assistance program and the established U.S. commercial infrastructure. There are two main initiatives aimed at increasing awareness – a direct-to-consumer, or DTC, digital marketing campaign and clinical education targeting HCPs. The DTC campaign targets social media audiences, primarily aimed at intensively managed patients seeking information about diabetes technology. The initial DTC campaign has resulted in nearly 50 million impressions or ads served to date through Facebook and Google. The campaign targets raising awareness and can be an effective sales tool for generating inbound leads. There is a strong consumer aspect to CGM as patients have the ability to ask their healthcare providers to prescribe Eversense. We anticipate that generating patient pull from DTC advertising will play an important role in driving overall adoption over time.

 

3

 

 

Senseonics 2Q21 Earnings Script
August 9, 2021

 

From the health care provider side, we remain actively engaged in scientific and industry meetings where we partner with Key Opinion Leaders who experience the positive clinical impacts and patient testimonials Eversense can have in managing patients’ diabetes and who can share those experiences with their peers. Two of the most important and well-attended meetings were held in the second quarter – the ADA, and the ATTD scientific conferences. Our presence at these meetings featured lead investigator Dr. Satish Garg’s presentation of the clinical data from the PROMISE study. The presentation highlighted the safety and accuracy profile of the Eversense 180-day sensor. Accuracy of the system with one calibration per day during the trial as measured by MARD was an industry leading 8.5%-9.1%. We are very proud of these results, which were well received by the broader diabetes community, and we look forward to seeing these results peer review published in the very near future.

 

Together with the Ascensia salesforce, we’re also actively and directly reaching out to local and national KOLs via one-on-one meet ups or small group discussions, in person, or tele-visits where required. We will remain engaged with the diabetes community not only to communicate the positive clinical impacts Eversense can have on diabetes management but also to learn and gather insights to fuel commercial, clinical and product development activities.

 

In addition, our initial involvement with an Accountable Care Organization, or ACO, is now in motion as well, with product on-site and ready to be inserted in the coming days at the University Hospital ACO in Cleveland, Ohio. They are the first accountable care organization to adopt Eversense into their practice. The initial program will include 20 Medicare diabetes patients on insulin regimens using the Eversense system for at least a year. The program will assess clinical outcomes such as A1c reduction and patient reported outcomes such as satisfaction levels during their use. We hope to learn and share valuable clinical information from the use of our long-term implantable CGM with this important managed care population.

 

4

 

 

Senseonics 2Q21 Earnings Script
August 9, 2021

 

Moving to progress outside the U.S., Ascensia sales professionals in the European countries have added Eversense to their sales portfolios and started marketing the system in February. This team has quickly learned the sales model for implantable CGM, as they all have extensive diabetes knowledge and familiarity with the market and its offerings.

 

Across European markets we executed smooth transitions from our prior distributors. Germany and Italy continue to represent two of our largest patient bases. In Germany, most payors cover Eversense and new contracts have been established with Ascensia. In Italy, we were able to transfer a majority of the previous contracts, including tenders. As different regions have experienced different impacts and regulations associated with COVID, which can complicate efforts to reach and train doctors with a new product, Ascensia is focused on servicing existing patients as restrictions allow. We are working closely to optimize sales channels to appropriate inventory levels to support and align with patient demand. They are off to a solid start OUS and are excited to now be marketing in Scandinavia as well.

 

With Ascensia assuming full commercial responsibilities, we have been able to focus and allocate our resources towards developing new products, strengthening our clinical profile, and advancing our regulatory activities, as we intended when entering into this collaboration. Market research of existing CGM patients shows that the two most sought-after features in a CGM system are sensor accuracy and extended sensor lifecycles. Studies have repeatedly shown that our sensors remain highly accurate throughout the full 180-day duration of the sensor life. Our growth strategy consists of offering patients’ improved benefits with each iteration of longer lasting, less intrusive Eversense sensors, which we believe will enable us to gain share and help expand the market for CGM. As evidenced through the reinsertion rates, our patient base has shown to be loyal, which we believe highlights the distinct, desired function and lifestyle benefits offered by Eversense.

 

5

 

 

Senseonics 2Q21 Earnings Script
August 9, 2021

 

On the U.S. regulatory side, the data gathered from the soon to be published PROMISE study is being used to support our 180-day product PMA supplement application, which as we previously announced was filed last fall. Following the Emergency Use Authorization delays, the submission was assigned a lead reviewer by the FDA on Apr 15th and we also reiterated the previous extended review timelines based on publicly made comments by the Agency officials.  At this time and based on the confidence in the strength and quality of our submission, and in discussion with the lead reviewer, we continue to expect the approval of the product by the end of 2021 though the constantly evolving situation with the pandemic and its impact on FDA workload make it hard to precisely estimate regulatory timelines.

 

Looking forward, we continue to make progress on our next generation technology platform. We are designing the system to have a lifespan of one year and require only one calibration per week and are actively working on its development. The attractiveness of this product to patients would represent another stepwise function that would address the needs of additional patients, and we believe, again revolutionize the CGM industry. The goal of bringing such a product to market represents our solution to the ultimate goal of lessening the burden of diabetes management and to offer people even more freedom. Our research and development activities are currently focused on working to realize this goal, with our efforts centered around the technical and chemical configuration of the sensor. Once the technical optimization is completed, we intend to submit the product to the FDA for an IDE approval to begin pivotal clinical testing. The development of the product has been steadily advancing, and we currently expect start the pivotal trial in the first half of next year.

 

6

 

 

Senseonics 2Q21 Earnings Script
August 9, 2021

 

I will now turn the call over to Nick to go over details of our second quarter financial results.

 

Nick Tressler

 

Thank you, Tim and good afternoon everyone. Our Q2 results reflect the full transition of commercial activities in the U.S. and E.U. to our partner Ascensia.

 

In the second quarter of 2021, total net revenue was $3.3 million compared to $261 thousand in the second quarter of 2020. US revenue for the second quarter was $1.0 million and revenue outside the US was $2.3 million.

 

Gross profit in Q2 2021 increased by $1.5 million year over year to $392 thousand. The positive gross margin in the quarter was primarily due to the fulfillment of orders utilizing existing written off inventory due to the COVID-19 pandemic.

 

 

Second quarter 2021 sales and marketing expenses decreased by $1.5 million year over year to $1.6 million, compared to $3.1 million in the prior year period. The decrease was primarily due to the strategic changes in our market commercialization approach through the Ascensia collaborative partnership.

 

Research and development expenses in Q2 2021 increased by $3.3 million year over year to $7.1 million, compared to $3.8 million in the prior year period. The increase was primarily driven by clinical study costs and personnel related expenses.

 

General and administrative expenses in Q2 2021 were $7.5 million, an increase of $3.1 million year over year, compared to $4.4 million in the prior year period, mostly due to an increase in personnel related costs.

 

7

 

 

Senseonics 2Q21 Earnings Script
August 9, 2021

 

For the three months ended June 30, 2021, operating loss was ($15.9M) compared to ($12.5M) in the second quarter of 2020. This represents a $3.4M increase in operating loss from one year ago.

 

The increase in the company’s share price at the end of the second quarter as compared the company’s share price at the end of the 1st quarter of 2021, led to significant non-cash charges in Q2. As a result, other expenses increased by $169.4 million compared to the prior year period primarily related to non-cash charges resulting from the accounting for imbedded derivatives and fair value adjustments related to the company’s financings including the 2023 and 2025 notes along with the PHC 2024 notes and Energy Capital equity line of credit. As required by U.S. Generally Accepted Accounting Principles or GAAP, we mark the value of these instruments to market for each reporting period and the change in these values are recorded as non-cash charges to the Income Statement. Each quarter the value of these non-cash gains or losses will vary based on the volatility in the company’s share price, so, generally, as share price increases, we incur a non-cash loss and as share price decreases, we recognize a non-cash gain. For the second quarter, the cash portion of the other expenses was $4.0M of interest expenses out of the total $164.4M.

 

For the three months ended June 30, 2021, total net loss was $180.3 million, or $0.42 per share, compared to $7.5 million or $0.03 per share, in the second quarter of 2020. Net loss increased by $172.8 million due to a $169.4 million increase to other expenses primarily related to the non-cash accounting charges from the accounting of the company financings previously mentioned, as well as a $3.4 million increase in loss from operations.

 

In the first half of 2021, our net cash used in operating activities was approximately $30.4M. As of June 30, 2021, cash, cash equivalents short and long-term investments totaled $215.0 million. This includes approximately $50 million in gross proceeds raised through our At-The-Market or ATM equity offering program. The use of proceeds will be primarily for debt service. Specifically, we will repay our PPP loan and have elected to pay the interest on the PHC notes in cash instead the Payment In Kind or PIK option. Paying the interest in cash raised from the use of the ATM will result in a significant reduction of shareholder dilution due to the lower share conversion price associated with the terms of the payment in kind agreement.

 

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Senseonics 2Q21 Earnings Script
August 9, 2021

 

Looking at the remainder of the year, we are reiterating our 2021 guidance. We continue to expect global revenues to Senseonics of between $12 and $15 million for 2021 with $6.1 million of revenue achieved in the first half. For full year 2021, net cash used in operations remains projected to be in the range of $60 to $65 million.

 

With that, I will turn it back to Tim.

 

Tim Goodnow

 

Thank you, Nick.

 

To wrap up, there were headwinds in the first half of the year as we worked with Ascensia to initiate their commercial activities. We reintroduced Eversense to the market with a new commercial partner amid the pandemic, which impacted both in-person actions to drive awareness and created delays in the review of our highly anticipated new product. These factors have gated us from achieving rapid patient adoption to date, but we believe we are better positioned to gain traction in the market with the right team and the right strategy to capitalize on the potential of Eversense. We are pleased to be working collaboratively with our partner on initiatives to drive growth, including increased patient and clinician marketing and launching the patient access program.

 

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Senseonics 2Q21 Earnings Script
August 9, 2021

 

We are confident in our product and its value proposition to users. Eversense users are continually commenting on how our system reduces the burden of managing their diabetes and we have been pleased with the many loyal users who already had awareness of Eversense. We see this as confirmation of our belief that our value proposition will resonate with the broader patient population. We are excited and motivated to offer more patients the same benefits. As we look forward to future generations of our technology, we are absolutely confident we can offer existing and new patient populations additional benefits, and build lasting patient and provider loyalty, that will contribute to our sustained growth and success as a business.

 

Thank you for your time today. Joining us for questions are Mukul Jain, our Chief Operating Officer; and Mirasol Panlilio, Vice President and General Manager of Global Commercial Operations. Operator let's open up the call for questions.

 

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