-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, CYjpeQrRKnJ/d/4ne7G/vTFsRBCnF/Tpc9qt2o7oMdZluwVz8clM/F5RMobUgYoI mhXQJMEAZNfUf7FqvvW0Xw== 0001193125-10-179377.txt : 20100805 0001193125-10-179377.hdr.sgml : 20100805 20100805161749 ACCESSION NUMBER: 0001193125-10-179377 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 6 CONFORMED PERIOD OF REPORT: 20100805 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20100805 DATE AS OF CHANGE: 20100805 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NeurogesX Inc CENTRAL INDEX KEY: 0001385830 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 943307935 STATE OF INCORPORATION: CA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-33438 FILM NUMBER: 10994707 BUSINESS ADDRESS: STREET 1: 2215 BRIDGEPOINTE PARKWAY STREET 2: SUITE 200 CITY: SAN MATEO STATE: CA ZIP: 94404 BUSINESS PHONE: 650-358-3300 MAIL ADDRESS: STREET 1: 2215 BRIDGEPOINTE PARKWAY STREET 2: SUITE 200 CITY: SAN MATEO STATE: CA ZIP: 94404 8-K 1 d8k.htm FORM 8-K Form 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

August 5, 2010 (August 5, 2010)

Date of Report (date of earliest event reported)

 

 

NEUROGESX, INC.

(Exact name of Registrant as specified in its charter)

 

 

 

Delaware   001-33438   94-3307935

(State or other jurisdiction of

incorporation or organization)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification Number)

2215 Bridgepointe Parkway, Suite 200, San Mateo, California 94404

(Address of principal executive offices)

(650) 358-3300

(Registrant’s telephone number, including area code)

N/A

(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))

 

 

 


Item 2.02. Results of Operations and Financial Condition.

On August 5, 2010, NeurogesX, Inc. (the “Company”) issued a press release regarding the Company’s financial results for the second quarter ended June 30, 2010 and held a teleconference to review these results and discuss recent developments. Copies of the press release and script are filed as Exhibits 99.1 and 99.2, respectively, to this Form 8-K, the contents of which are incorporated by reference into this Item 2.02.

 

Item 8.01. Other Events

The discussion set forth in Item 2.02 above is hereby incorporated by reference into this Item 8.01, as well as the contents of the press release and script filed as Exhibits 99.1 and 99.2, respectively, and is deemed to be filed for purposes of the Securities Exchange Act of 1934, as amended.

On August 5, 2010, the Company also issued a press release regarding its plans to file a universal shelf registration on Form S-3 with the Securities and Exchange Commission. A copy of the press release relating to the shelf filing is being filed as Exhibit 99.3 and is incorporated by reference into this Item 8.01.

 

Item 9.01. Financial Statements and Exhibits.

 

  (d) Exhibits

 

Exhibit 99.1    Press release entitled “NeurogesX Reports Second Quarter 2010 Results.”
Exhibit 99.2    Script of August 5, 2010 teleconference.
Exhibit 99.3    Press release entitled “NeurogesX Announces Proposed Shelf Registration Statement.”


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.

 

    NEUROGESX, INC.
Date: August 5, 2010     By:  

/S/    STEPHEN F. GHIGLIERI        

      Stephen F. Ghiglieri
     

Executive Vice President, Chief Operating Officer

Chief Financial Officer


EXHIBIT LIST

 

Exhibit 99.1    Press release entitled “NeurogesX Reports Second Quarter 2010 Results.”
Exhibit 99.2    Script of August 5, 2010 teleconference.
Exhibit 99.3    Press release entitled “NeurogesX Announces Proposed Shelf Registration Statement.”
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

LOGO

 

NeurogesX, Inc.

Stephen Ghiglieri

Executive Vice President, COO

and CFO

(650) 358-3310

  

The Ruth Group

Sara Pellegrino (investors)

(646) 536-7002

spellegrino@theruthgroup.com

 

Jason Rando (media)

(646) 536-7025

jrando@theruthgroup.com

NeurogesX Reports Second Quarter 2010 Results

Conference Call Today at 4:30pm ET

Recent Highlights:

 

   

Qutenza launched in April, 2010

 

   

Qutenza available and/or on formulary at 60 U.S. hospitals

 

   

Astellas initiates Qutenza E.U. launch in Germany, Austria, and the UK

 

   

Completed $40 million royalty based debt financing

Upcoming 2010 Milestones:

 

   

Qutenza launch in additional E.U. markets by Astellas

 

   

Initiation of Phase 2 clinical trial of NGX-1998 in PHN patients

San Mateo, Calif., (August 5, 2010) – NeurogesX, Inc. (Nasdaq: NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, today reported results for its second quarter ended June 30, 2010.

During the second quarter of 2010, NeurogesX initiated the U.S. launch of Qutenza® (capsaicin) 8% patch for the management of neuropathic pain associated with postherpetic neuralgia (PHN), through targeted physician outreach, in-office training, and support for patient access to treatment and reimbursement. During the early launch phase, the NeurogesX sales team is focused on targeting hospitals, pain centers, and private pain specialists to establish a national network of Qutenza-experienced physicians (Qutenza Practice Referral Optimization or “QPRO” Centers of Excellence) that can provide treatment and serve as referral centers for PHN patients. The Company continues to progress with its reimbursement strategy which has three primary elements: 1) obtain coverage under medical benefit (Medicare Part B and private payers) for Qutenza; 2) establish coding for both Qutenza and the application procedure; and 3) provide customer billing support through the Insight:Qutenza Reimbursement Support Program.


LOGO

 

Anthony DiTonno, President and CEO, commented, “A primary goal of the U.S. Qutenza launch is to maximize long-term value by creating a positive initial experience for both physician offices and their patients. This process will take time to execute but the early feedback suggests that we are on the right path. I am very pleased with the progress we have made in regards to our reimbursement strategy, which is creating access to Qutenza for PHN patients, as well as the performance of our sales and marketing team in implementing our QPRO strategy. I believe we are currently building the foundation that will enable Qutenza to become a significant option for physicians when treating their PHN patients.”

In the European Union, Qutenza was launched in the second quarter 2010 by NeurogesX’ commercial partner Astellas Pharma Europe Ltd. (Astellas), and is now available in Germany, Austria, and the UK with initial launch activities focused on intensive site training. During the second half of 2010, Astellas plans to launch Qutenza further into more European markets increasing their presence in the pain management arena.

Moving into the second half of 2010, NeurogesX plans to resume clinical development of NGX-1998, a second-generation liquid formulation of high-concentration capsaicin. Preparations are underway to initiate a Phase 2 adaptive-design clinical study in PHN patients to evaluate the potential of NGX-1998 to provide safety and efficacy in a shorter time frame than is required for Qutenza. The Company is also continuing to evaluate its path forward with regard to Qutenza for the HIV distal sensory polyneuropathy (HIV-DSP) and painful diabetic neuropathy (PDN) indications. The Company is scheduled to meet with the FDA later this year to discuss the HIV-DSP indication and potential paths forward for this program. For PDN, the Company is continuing to evaluate further development in light of Astellas’ plans to address certain post-market commitments in the European Union.

Second Quarter 2010 Results

Since the U.S. launch of Qutenza on April 5, 2010, the Company recorded sales of Qutenza to its specialty distribution and specialty pharmacy customers totaling $308,000, of which $33,000 was recorded as Qutenza revenue for the second quarter 2010. Due to limited history of product returns and launch-related programs, including extended payment programs, NeurogesX is deferring revenue recognition of the remaining $275,000 in Qutenza sales to these customers. Of the deferred revenue total, $122,000 was sold through to end user customers (i.e. physicians, clinics and hospitals) and the deferral has resulted from launch related extended payment terms, while $153,000 represents deferral of sales into the company’s distribution channel, recognition of which will be based upon ultimate sales of those units to end user customers. Deferred revenue is reported net of associated cost of goods sold on the Company’s balance sheet.

Collaboration revenue for the second quarter of 2010 was $2.1 million, consisting of $1.9 million in amortization of upfront payments received in connection with the Astellas Agreement, and $0.2 million to reflect a difference between the carrying costs and contractual transfer price of Qutenza supply sold to Astellas. Under the Astellas Supply Agreement, NeurogesX is obligated to supply Astellas with Qutenza at a contractually agreed upon cost for materials, related labor, and overhead, until Astellas establishes its own suppliers.


LOGO

 

Total operating expenses were approximately $11.1 million for the second quarter of 2010, up from approximately $5.4 million in the year ago period. This increase was due primarily to an increase in selling, general and administrative expenses offset by a minor reduction in research and development expenses.

Cost of goods sold for the second quarter of 2010 totaled $45,000 for the quarter and consisted mainly of fixed monthly charges related to our third party logistics provider for warehousing, and shipping activities during the quarter.

Research and development expenses were approximately $2.7 million for the second quarter of 2010, compared to approximately $2.8 million in the year ago period. The year-over-year decrease of $0.1 million primarily reflected costs to support and maintain the FDA approval of Qutenza during the second quarter 2010, compared to the costs associated with obtaining the FDA approval during the year ago period.

Selling, General and Administrative (SG&A) expenses were $8.3 million during the second quarter 2010, up from $2.6 million in the second quarter 2009. This increase was due in large part to the commercial launch of Qutenza in the United States in April, 2010. Specifically, the increases included a $2.6 million increase in costs associated with our sales and commercial operations organization including salary and related expenses; $2.1 million related to marketing materials development and other launch-related marketing costs; and to a lesser extent, increases in our medical affairs and general and administrative functions. During the year ago period, limited pre-commercialization activities were performed as marketing authorization for Qutenza had been received only in the E.U. and was pending in the U.S.

Net loss for the second quarter of 2010 was $10.2 million, compared to a net loss of $5.4 million for the second quarter of 2009. Net loss per share was $0.58 and $0.31 for the three months ended June 30, 2010 and 2009, respectively, based on weighted average shares outstanding of 17,748,720 and 17,580,158, respectively. The weighted average shares used in computing net loss per share for all periods presented exclude anti-dilutive securities, such as stock options and warrants.

Cash, cash equivalents and short-term investments were $67.9 million at June 30, 2010, compared to $40.1 million at March 31, 2010.

Stephen Ghiglieri, EVP, COO and CFO, commented, “We are pleased with the market acceptance of Qutenza to date. Given our approach for establishing the market for Qutenza which involves a substantial selling process that may take weeks to months to establish a Qutenza treating physician practice, metrics to evaluate success are different than your average retail pharmaceutical product launch. Qutenza represents a treatment innovation with the potential to provide neuropathic pain relief in patients with PHN and we are pleased with our progress to date.”


LOGO

 

Conference Call Details

The Company will hold its quarterly conference call today at 4:30 p.m. ET (1:30 p.m. PT) to discuss second quarter 2010 results.

To participate, please dial 1-877-407-0789 (USA) or 1-201-689-8562 (International). To access the live web cast please visit the Investor Relations section on the corporate web site at http://www.neurogesx.com.

A replay of the conference call will be available beginning August 5, 2010 at 7:30 p.m. ET (4:30 p.m. PT) and ending on August 15, 2010 by dialing 1-877-870-5176 (USA) or 1-858-384-5517 (International), Account Number: 3055, Conference ID Number: 354780. A replay of the webcast will also be available on the corporate website for one month, through September 5, 2010.

About Qutenza®

Qutenza® (capsaicin) 8% patch, a localized dermal delivery system containing a prescription strength capsaicin, is approved by the U.S. Food and Drug Administration (FDA) for the management of neuropathic pain associated with postherpetic neuralgia (PHN).

Clinical studies have shown that a single one-hour Qutenza application can provide three months relief from pain associated with postherpetic neuralgia (PHN), the nerve pain that can occur after shingles.

In clinical trials, serious adverse reactions included application-associated pain and increase in blood pressure. The most common treatment-emergent adverse reactions (greater than or equal to 5% of Qutenza patients and greater than control) were application-site erythema, application-site pain, application-site pruritus, and application-site papules.

Qutenza is also approved in the E.U. and is marketed by Astellas Pharma Europe Ltd. (Astellas), the European subsidiary of Tokyo-based Astellas Pharma Inc.

About NeurogesX, Inc.

NeurogesX, Inc. (Nasdaq: NGSX) is a San Francisco Bay Area-based biopharmaceutical company focused on developing and commercializing novel pain management therapies. NeurogesX was founded on the concept that use of prescription-strength capsaicin could help manage the pain associated with neuropathic pain conditions. Since its inception, NeurogesX has leveraged its passion to help people with pain to efficiently develop this concept, resulting in the commercial launch of Qutenza® (capsaicin) 8% patch in 2010. The Company continues to apply its knowledge and expertise in the development of other novel treatments for pain.


LOGO

 

The Company’s lead product, Qutenza, is a localized dermal delivery system containing prescription strength capsaicin that is currently approved in the United States and the European Union. Qutenza is now available in the United States for the management of neuropathic pain associated with postherpetic neuralgia (PHN). In Europe, Qutenza is being marketed by Astellas Pharma Europe Ltd. (Astellas), the European subsidiary of Tokyo-based Astellas Pharma Inc.

The Company’s most advanced product candidate, NGX-1998, is a topically applied liquid formulation containing a high concentration of capsaicin designed to treat pain associated with neuropathic pain conditions such as PHN. NGX-1998 has completed three Phase 1 studies.

The Company’s early-stage product pipeline includes pre-clinical compounds which are prodrugs of acetaminophen and various opioids. The Company has evaluated these compounds in vitro and in vivo.

Safe Harbor Statement

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). NeurogesX disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include but are not limited to: statements regarding the safety and efficacy of Qutenza® including any timing or approval of any expansions on indication and market acceptance of Qutenza by patients and healthcare providers; planned commercialization and sales strategies, as well as the expected benefits of such strategies and the effect such strategies may have on sales and revenue expectations; expectations regarding reimbursement for Qutenza, including the receipt and timing of any product specific reimbursement codes; sales and marketing expenses for 2010 and into 2011; the timing and scope of commercial launch of Qutenza in the United States and European Union; the timing of re-entry of NGX-1998 into clinical development; and the sufficiency of cash resources to fund the Company’s operations. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to: difficulties or delays in the commercialization of Qutenza, including with respect to manufacture and supply of Qutenza; Qutenza may have unexpected adverse side effects; physician or patient reluctance to use Qutenza; and other difficulties or delays in the launch of Qutenza by Astellas in the European Union. For further information regarding these and other risks related to NeurogesX’ business, investors should consult NeurogesX’ filings with the Securities and Exchange Commission.


LOGO

 

NeurogesX, Inc.

Condensed Consolidated Statements of Operations

(in thousands, except share and per share data)

(unaudited)

 

     Three Months Ended
June 30,
    Six Months Ended
June 30,
 
     2010     2009     2010     2009  

Net product revenue

   $ 33      $ —        $ 33      $ —     

Collaborative revenue

     2,051        —          3,837        —     
                                

Total Revenues

     2,084        —          3,870        —     
                                

Operating expenses:

        

Cost of goods sold

     45        —          45        —     

Research and development

     2,745        2,780        4,868        5,106   

Selling, general and administrative

     8,271        2,605        17,078        4,794   
                                

Total operating expenses

     11,061        5,385        21,991        9,900   
                                

Loss from operations

     (8,977     (5,385     (18,121     (9,900

Interest income

     22        11        29        45   

Interest expense

     (1,289     (68     (1,289     (188

Other income (expense), net

     11        10        (16     10   
                                

Net loss

   $ (10,233   $ (5,432   $ (19,397   $ (10,033
                                

Basic and diluted net loss per share

   $ (0.58   $ (0.31   $ (1.09   $ (0.57
                                

Shares used to compute basic and diluted net loss per share

     17,748,720        17,580,158        17,737,499        17,574,455   
                                


LOGO

 

NeurogesX, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share and per share information)

 

     June 30,
2010
    December 31,
2009
 
     (unaudited)     (Note 1)  
Assets     

Current assets:

    

Cash and cash equivalents

   $ 14,690      $ 29,695   

Short term investments

     53,197        20,864   

Receivable from collaborative partner

     798        678   

Trade receivable

     186        —     

Prepaid expenses and other current assets

     1,024        769   

Restricted cash

     290        40   

Inventories, net

     1,091        —     
                

Total current assets

     71,276        52,046   

Property and equipment, net

     935        739   

Other assets

     246        —     

Restricted cash

     120        120   
                

Total Assets

   $ 72,577      $ 52,905   
                
Liabilities and Stockholders’ Equity (Deficit)     

Liabilities

    

Current Liabilities

    

Accounts payable

   $ 1,388      $ 65   

Accrued compensation

     1,225        2,157   

Accrued license fees

     —          1,213   

Accrued research and development

     517        670   

Other accrued expenses

     3,426        1,222   

Deferred product revenue, net

     256        —     

Deferred collaborative revenue

     7,242        7,242   

Notes payable - current portion

     —          191   
                

Total current liabilities

     14,054        12,760   

Non-current liabilities

    

Deferred collaborative revenue

     36,010        39,601   

Deferred rent

     208        291   

Long term obligations

     39,518        —     

Interest payable on long term obligations

     597        —     
                

Total non-current liabilities

     76,333        39,892   

Stockholders’ equity (deficit):

    

Common Stock

     18        18   

Additional paid-in capital

     213,575        212,254   

Accumulated other comprehensive income

     5        (8

Accumulated deficit

     (231,408     (212,011
                

Total stockholders’ equity (deficit)

     (17,810     253   
                

Total liabilities and stockholders’ equity (deficit)

   $ 72,577      $ 52,905   
                

(Note 1) The balance sheet at December 31, 2009, has been derived from the audited consolidated financial statements at that date.

EX-99.2 3 dex992.htm SCRIPT OF AUGUST 5, 2010 TELECONFERENCE Script of August 5, 2010 teleconference

Exhibit 99.2

NeurogesX, Inc.

Second Quarter 2010 Conference Call

August 5, 2010

Operator:

Greetings ladies and gentlemen and welcome to the NeurogesX Inc. second Quarter 2010 conference call.

At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star-zero on your telephone keypad. As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Ms. Carol Ruth of The Ruth Group. Thank you Ms. Ruth. You may begin.

TRG:

Thank you, Operator. Joining us on the call today are Tony DiTonno, Chief Executive Officer and Stephen Ghiglieri, Executive Vice President, Chief Operating Officer and Chief Financial Officer.

Statements in this conference call regarding NeurogesX business which are not historical facts may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995, or “The Act.” NeurogesX disclaims any intent or obligation to update these forward-looking statements and claims protection of the Safe Harbor for forward-looking statements contained in the Act.

Forward looking statements may include, but are not limited to, statements regarding the safety and efficacy of Qutenza® including any timing or approval of any expansions on indication; planned commercialization and sales strategies, as well as the expected benefits of such strategies and the effect such strategies may have on sales and revenue expectations; expectations regarding reimbursement for Qutenza, including the receipt and timing of any product specific reimbursement codes; the estimated usage profile of patients that may use Qutenza and physicians that may prescribe Qutenza; sales and marketing expenses for 2010 and into 2011, including the rate of increase of such expenses over 2010 and into 2011; the timing and scope of commercial launch of Qutenza in the United States and European Union; the roles and activities of Astellas in commercialization of Qutenza in the European Union; the timing of re-entry of NGX-1998 into clinical development; the sufficiency of cash resources to fund the Company’s operations into late 2011; and expected sources of capital.

 

1


Actual results may differ from these discussed here today. Factors that may affect the outcome of forward-looking statements are explained in the risk factors section of our filings with SEC, including our Form 10-K, which we filed with the SEC on March 19, 2010 as updated by our Form 10-Q filing as filed with the SEC on May 14, 2010 and our most recent Form 10-Q for the second quarter of 2010, which will be filed with the SEC next week.

Now I would like to turn the call over to Tony DiTonno, Chief Executive Officer of NeurogesX.

Anthony DiTonno:

Thank you, Carol and thank you all for joining us today.

The second quarter 2010 reflects the results of our initial three-month period as a commercial enterprise. Our goal on today’s call is to give you an update on the launch of Qutenza® in the U.S. and Europe. In this discussion, we will update you on key launch metrics, including an update on our reimbursement progress, to help gauge the success of Qutenza in the market. We also have exciting opportunities ahead for our clinical pipeline, and will talk a little bit later about our progress towards initiating a Phase 2 trial for NGX-1998. Stephen will also be providing additional insights into the financial results for the quarter.

The launch of Qutenza is proceeding well as measured by the key metrics we will be discussing shortly. Given the unique selling proposition for Qutenza as a single, one hour, localized treatment that can provide 3 months of relief from pain associated with postherpetic neuralgia, or PHN, we have spent considerable time over the last few conference calls highlighting the Qutenza “total office call” and its impact on the Qutenza launch. This approach results in a significantly different launch ramp from your typical retail pharmaceutical product launch, which only requires the physician to write a prescription before the sale can take place. Briefly, I would like to revisit this approach as an important foundation for understanding our second quarter 2010 results and setting expectations for the next few quarters.

 

2


Our 40 sales professionals are initially targeting the top treaters of PHN patients in private practices, hospitals, Military Treatment Facilities and VA’s. Our focus requires considerable time and effort to educate and train physician offices prior to their initial Qutenza treatments. Our sales force exceeded our second quarter “Reach” goal, and by the end of July we had secured face-to-face interactions with nearly 1400 of the approximately 2000 - 3000 high decile physicians we are targeting in the first year of launch.

We also reached and profiled an additional 2400 physicians from our target list of approximately 20,000 deciled physicians to validate these targets going forward. Reflecting the success of our physician outreach, over 500 physicians (and their support staffs) have now been trained on proper Qutenza administration, of which roughly half were trained by our clinical educators and the other half through our sales professionals or other available training programs. We currently have just under 50 physicians awaiting training.

By the end of the second quarter 100 unique users have purchased or prescribed Qutenza and we are pleased to report that this number increased by just over 50% in the month of July. Repeat users have also nearly doubled from the end of the quarter through July. We believe that the recent increases in new and repeat users, albeit off a small base, are reflective of the momentum we are beginning to see in the market. For this discussion, when we talk about users, we are referring to individual physicians, physician practices as well as institutions such as hospitals and clinics. We believe that the “total office call” is preparing physicians, their staffs and their patients to have a positive experience with Qutenza and that this will increasingly lead to both new users and increasing repeat users in the quarters to come.

 

3


As part of our highly targeted selling strategy, we are working to establish a national network of “Centers of Excellence,” that offer Qutenza in their practice and who want to be referral centers for PHN patients who may benefit from Qutenza. To assist with this effort, our Qutenza Practice Referral Optimization, or QPRO, Program has been implemented to help drive patients and physician referrals towards these centers of excellence. For Qutenza to succeed, we don’t need every physician to administer Qutenza, but we do need patients around the country to have access to local physician practices or institutions that can administer Qutenza. While this program is just getting off the ground, we believe that it will be a key element in helping to provide national patient access to Qutenza. By helping QPRO accounts communicate information about Qutenza to their patients, referring physicians, advocacy groups and media PHN patients can be directed to these practices for possible treatment with Qutenza.

Another recently implemented support tool for helping patients access Qutenza is the “Find a Doctor” program on the Qutenza Website. This program helps PHN referring physicians and patients find a physician practice that offers Qutenza in their local areas through search functions that include Name, City and Zip Code searches. Since we started “Find a Doctor” in mid June 80 physicians enrolled in the program as of earlier this week. We expect this program to gain momentum in the coming months as more physicians gain experience with Qutenza.

As we have mentioned on earlier calls, our primary objective for the U.S. launch is to ensure a positive initial experience with Qutenza for patients, physicians and their office staff. Training on how to administer and receive reimbursement for Qutenza is required for us to accomplish this goal. Our Pain Education Network, or PEN, and our reimbursement support programs are important aspects of our launch strategy that have been well received by our customers. Our sales force is leveraging PEN, our national network of approximately 75 clinical educators, to schedule and provide in-office trainings before the first patient is treated. To supplement these efforts, we also have on-line training and other physician education tools. Since Qutenza administration involves physicians, nurses and other staff, it usually takes more than one visit to train the full office. By the way you can visit the Qutenza.com website and see many of these programs first hand.

 

4


Of course, payer coverage as well as timely and adequate reimbursement is a major factor in the initial Qutenza experience. Our reimbursement support program and a team of reimbursement managers are actively assisting patients and physicians, and working with payers to facilitate access to Qutenza treatment. The uncertainty of timing for reimbursement has prompted most users to ask the reimbursement support program to verify benefits for patients prior to treatment, so that they can understand each patient’s coverage and minimize their financial risk. Even with our 120-day deferred payment launch terms, many physicians want to have experience getting paid. As a result, physicians are inclined to treat a single patient and see how reimbursement goes before treating additional patients. Other physicians wish to wait to hear how their colleagues are faring in the reimbursement process before incorporating Qutenza into their practices. As physicians treat their first patients with Qutenza and begin receiving explanation of benefits, or EOB’s, which can take 30-60 days from claim submission, we believe that they will begin expanding their use of Qutenza, assuming they are reasonably satisfied with reimbursement received for their time and the cost of Qutenza. The time required to train offices and secure initial reimbursement has been factored into our guidance for gradual uptake during the initial launch phase.

While we are on the subject of reimbursement, now is a great time to highlight our recent progress. Only four months into launch, the evidence on claims submitted and resolved through our reimbursement support program is encouraging. Through July 30, 2010, nearly 450 benefit investigations have been submitted to our reimbursement support group and about 3% resulted in a denial of benefit. Of those submitted, just under half represent Medicare claims, for which there have been no denials, and the balance represent private payer claims.

 

5


With regard to Medicare, we received Medicare Part B coverage for Qutenza in all 50 states, much sooner after launch than we expected. Additionally, CMS has granted Qutenza a specific C-code (C9268) to facilitate Medicare hospital outpatient reimbursement until a permanent J code is established, which is expected in January 2011.

In addition to the progress we have made with Medicare, we are also pleased with our progress on the private payer side. We are focusing our efforts on the approximately 50 U.S. managed care organizations that encompass approximately 90% of covered lives. Discussions with these organizations represent a process which often starts with building product awareness, then may lead to approval with restrictions and ultimately we hope may evolve to a positive coverage determination.

The hospital outpatient setting is a very important part of our Qutenza launch strategy as these institutions are well positioned for offering Qutenza treatments. Our team has made good progress as several large influential institutions have added Qutenza to their formularies. At institutions where we have gained formulary access, buying patterns have far exceeded other providers, and hospital purchases accounted for over 60% of our second quarter sales to end users. Qutenza is currently available either on formulary or otherwise at 60 U.S. hospitals and another 50 institutions are currently evaluating Qutenza for addition to their formularies. Although it takes some time to get on these formularies, we believe this early uptake suggests that hospital outpatient clinics will likely be a significant source of our sales activity going forward.

Starting October 1 we expect CMS to publish an average selling price, or ASP, for Qutenza. As you know, physicians will be reimbursed at ASP + 6% for Qutenza under Medicare Part B. Presently 7 of 12 Medicare contractors are reimbursing physicians based on the invoiced amount until an ASP is published by CMS. Shifting to ASP-based payments starting in October in states where contractors are reimbursing based on invoices will result in about $40.00 per patch for these physicians. We believe that publication of an ASP for Qutenza and the improved reimbursement it represents is important in expanding use of Qutenza.

 

6


Regarding coding and reimbursement for the Qutenza treatment procedure, all Medicare carriers have provided, and in some cases published, guidance on coding for physicians’ professional services related to Qutenza administration. Generally Medicare contractors are recommending providers use evaluation and management (E&M) codes to bill for the Qutenza procedure. E&M codes range from levels 1 to 5 based on a number of factors, including extent of history obtained, extent of examination performed and the complexity of medical decision making involved. It is not yet clear which Level E&M code physicians typically select when administering Qutenza. However, two Medicare contractors have published provider guidance that anticipates claims for the Qutenza application procedure would be billed with a Level 3 or 4 E&M code. Medicare payments for E&M codes vary by geography. The average allowable Medicare payment for Level 3 and 4 codes for an established patient and a participating physician are $68 and $108, respectively. Private payers, for the most part, have been following Medicare’s lead and are asking providers to use an E&M, or less frequently the 64999 code for an unlisted neurology procedure code. The payment rates for private payers are generally 150% to 200% of the allowable Medicare payment, although this can vary widely depending on local market factors.

As you can see, we’ve made significant headway in reaching and training physicians on the proper use of Qutenza, and progress with reimbursement is beginning to drive repeat customers. While we continue to reach and train new physicians, and gain access through hospital formularies, we continue to expect it will take at least four quarters from launch before revenue trends can begin to be analyzed to gauge long term product potential. For the time being, our favorable metrics on physician conversion and feedback from the field leave us confident that our strategy is effective.

Another potential leading indicator for us relates to our Medical Affairs function, a group within our organization that is staffed with MD’s, PharmD’s and PhDs. Their jobs include responding to medical information requests from physicians and patients, currently we are averaging over 100 inquiries a month, split roughly 50/50 between physician and patient requests.

 

7


Before I turn the call over to Stephen, I would like to provide a brief update on the Qutenza launch in Europe, as well as our clinical pipeline. In late May, I had the opportunity to participate in the NeuPSIG conference in Athens, where Astellas introduced Qutenza to the European pain community. I was extremely impressed with their professionalism and their commitment to the product, from the CEO of Astellas Europe to the country managers I had the pleasure of meeting. Astellas’ approach is very similar to ours, with a focus on training, ensuring knowledgeable physicians who will assist in the introduction of Qutenza across their markets. Astellas has been fully engaged in what we believe to be necessary activities to ensure success of Qutenza and as planned, the focus during the quarter has been to fully train specialist pain centers on the use of Qutenza and not on current period revenue generation. At the end of our second quarter, Qutenza was available in Germany, Austria, and the UK. We expect that during the second half of 2010 Astellas will launch Qutenza into more European markets, further increasing their presence in the Pain Specialist arena.

Regarding our clinical pipeline, we are moving steadily ahead on our plans to dose the first patient in our Phase 2 adaptive-design study of NGX-1998, our second capsaicin-based product candidate. NGX-1998 is a liquid formulation developed to provide greater versatility and to optimize rapid capsaicin delivery. Our desired end result is a reduction in overall treatment time required to deliver an efficacious dose of capsaicin. We have already begun study site selection, are planning an investigator meeting to be held in the third quarter, and expect to begin enrolling patients in the Phase 2 study before the end of the year. The objective of this study is to assess tolerability, determine the minimum time for the treatment procedure and select a capsaicin concentration for evaluation in the subsequent phase 3 program, expected to begin in 2012.

We are also evaluating potential post-approval clinical support studies with Qutenza. We are continuing to assess our HIV-DSP data and planning to discuss with the FDA the best path forward utilizing HIV –DSP data from our previous studies. Astellas is continuing to evaluate plans for a clinical study in painful diabetic neuropathy, or PDN, and our U.S. strategy with regard to PDN will continue to be evaluated in light of whatever work Astellas decides to do in this patient population to address E.U. regulatory requirements.

 

8


Stephen will now discuss our financial results for the quarter

Stephen Ghiglieri

Thanks, Tony. Our results for the second quarter 2010 are summarized in today’s earnings release which if you don’t already have, may be accessed on our website. In addition, we expect to file our Form 10-Q with the SEC next week, where you will find more detailed disclosures about our quarterly results. This being our first quarter after the commercial launch of Qutenza, I will be touching on a number of new areas in this conference call. First, I would like to talk about sales and revenue recognition.

As you know, we launched Qutenza on April 5. Our launch is being conducted by our own sales force which numbers 40 professionals. As Tony has already mentioned, our focus on the Qutenza “total office call” and our QPRO program are key elements of our strategy to build Qutenza into a valuable long term product. During the second quarter, we saw significant evidence of this strategy bearing fruit – and as we have discussed many times, product sales and revenue recognition are not the criteria by which we are measuring success for at least the next few quarters.

We have established a distribution channel which currently includes both specialty pharmacies and specialty distributors. The product we sell them is carried in their own inventory for ultimate sale to the end user – that is, physicians, clinics and hospitals who will treat patients with Qutenza. Our sales to our distribution network are where legal title passes and as such, this transaction results in our recording a sale and a receivable.

Pretty straightforward so far. However, due to accounting rules which require that we have a predictable pattern of return goods from those distributors before revenue can be recognized from our sales to distributors, for the near term we will defer revenue until we have evidence of distributors’ sales to an end user, which eliminates the potential for a product return.

 

9


Each of our distributors has agreed to abide by our return goods policy which is fairly restrictive and allows for the return of goods in three situations 1) if we shipped an order incorrectly, 2) if we shipped damaged goods and 3) if they have product which falls below a specified remaining shelf life threshold. Given this restrictive return goods policy, we anticipate a low level of product returns. This expectation is further supported by the fact that our distributors typically will carry a relatively small amount of inventory – usually 2 to 4 weeks. Regardless of these facts, we need experience to demonstrate that returns will not be significant – which typically is not possible until you have a sales history, which could take many quarters or even years. To obtain evidence of product sold through, we receive weekly data feeds from our distributors on product quantity sold through to end users – and this information provides the basis for what you will see in our income statements as recognized revenue for the foreseeable future.

During the second quarter, we sold $308,000 of Qutenza to our distributors, of which $153,000 remained as inventory in the distribution channel at the end of the quarter. We had evidence of “sell through” for a total of $155,000 of this amount and most quarters, this “sell through” amount would be our reported revenue. However, as a result of a launch program which provided extended payment terms to our specialty distributor customers, we have had to defer, revenue under that program until we are paid (which we expect to occur in the very near term). This extended payment program will expire at the end of August, so its effect will be less significant next quarter and should be completely washed through by the end of the year.

The revenue we did report, which totals $33,000, represents only the sell through from specialty pharmacy customers who were not included in the deferred payment program. During the quarter, we had only limited adjustments to gross sales – related to traditional discounts provided on government sales. Other than government discounts for such entities as public health facilities, VA and Medicaid, we do not currently have discounted sales programs. Included as an offset to our deferred revenue is approximately $5,000 of these government related discounts. In addition, on a go forward basis we will expect to net certain fees from our distributors against gross revenues, which we expect to total less than 5% of gross revenue.

 

10


Collaboration revenue in the second quarter 2010 totaled $2.1 million, which is principally comprised of $1.9 million in amortization of upfront payments received under our commercialization agreement with Astellas. In addition, we reported approximately $0.2 million of collaboration revenue representing net profit on supply of product to Astellas. The majority of this revenue results from our having expensed certain product costs in periods prior to receiving regulatory approval and subsequently selling that product to Astellas during this most recent quarter. Going forward we don’t expect to make a significant net profit or loss on sales of product to Astellas.

During the second quarter 2010, Astellas also made progress, as Tony mentioned previously, having introduced Qutenza in Germany, Austria and the United Kingdom. Although the vast majority of their activities were related to intensive physician training, they did report their first sales of Qutenza as well. As a reminder, we earn a royalty on Astellas’s net sales at a rate which starts in the high teens. Astellas is also responsible for paying third party royalties to UC and LTS on their net sales. We will be reporting Astellas royalties on a quarter lag basis to ensure adequate time to receive and incorporate this information into our quarterly reporting. Therefore, we reported no revenue from Astellas’ Qutenza sales this quarter. However, based upon the recently received royalty report, we expect our royalty on Astellas sales for the quarter ended June 30, to be nominal.

Total operating expenses for the second quarter 2010 were $11.1 million, a 106% increase from the $5.4 million we reported in the year ago period. This increase is due to higher selling general and administrative expenses due to the Qutenza product launch, offset by a minor decrease in our research and development expense that I will address in moment.

 

11


For the quarter, we recognized cost of goods totaling $45,000. Included in our cost of goods is the manufacturing cost for our products as well as certain costs associated with our third party logistics provider that manages the warehouse where our product is stored and provides the pick, pack and ship function for us. Much of the fees for this service are on a fixed cost basis. As a result, given the small amount of revenue recognized during this quarter, we ended up with negative margins. We will likely see a reduction in our target margins for the next few quarters but ultimately we believe that margins should be in the range of 90%.

Research and development expenses for the quarter totaled $2.7 million and were essentially flat with the second quarter of 2009. Activities in the quarter ended June 30, 2010 included maintenance of our NDA for Qutenza and general regulatory support, as well as the ramp of activities in our NGX-1998 development program, including non-clinical studies, formulation work and activities to support our initiation of a Phase 2 study in NGX-1998, which we expect to kick off towards the end of this year. In the second quarter of 2009, we were engaged in completing the MAA review process and supporting the FDA’s review of our NDA for Qutenza and also included a small study in Qutenza which we performed at the request of the FDA.

Selling, general and administrative expenses totaled $8.3 million for the second quarter of 2010, which represents a 219% increase over the $2.6 million we reported in the second quarter of 2009. This increase is due primarily to the commercialization of Qutenza, including the deployment of our sales force, ongoing costs of commercial operations, marketing costs associated with our launch, and reimbursement support activities. Additionally, we saw increases in our medical affairs function and general and administrative functions all mainly in support of commencing commercial operations.

 

12


We recorded $1.3 million of interest expense this quarter, resulting from our royalty financing transaction with Cowen Healthcare Royalty Partners. In April, we signed this $40 million debt facility which is secured by and will be repaid through the royalties and milestones that result from our commercialization agreement with Astellas. Under this agreement, we will accrue interest at 19%, which we estimate to be the effective interest rate of the debt facility. To the extent that revenue in flows from Astellas do not cover currently due interest, the residual or unpaid interest will become principal. As a result, for the next few quarters we would expect that our debt obligation to Cowen will continue to grow on our balance sheet. Once quarterly proceeds from Astellas are sufficient to meet currently due interest, the debt obligation will begin to be paid down.

Net loss for the second quarter of 2010 was $10.2 million compared to a net loss of $5.4 million for the second quarter of 2009. Net loss per share totaled $0.58 and $0.31 for the three months ended June 30, 2010 and 2009 respectively, based upon weighted average shares outstanding of 17.7 million and 17.6 million respectively. The weighted average shares used in computing loss per share for both periods presented exclude anti-dilutive securities, such as stock options and warrants.

Cash, cash equivalents and short-term investments were $67.9 million at June 30, 2010, compared to $40.1 million at March 31, 2010. This increase in cash is due to our closing the debt facility with Cowen Healthcare Royalty Partners as previously discussed, offset by our cash burn during the quarter which totaled $11.7 million. We expect that our cash burn will continue in the range of $10 million to $12 million per quarter for the remainder of the year and we believe that our current cash resources are sufficient to last at least into late 2011.

On a final note, we also announced today that we are preparing to file a shelf registration statement in the next week or two. We expect this to be a $75 million universal shelf which we believe to be an appropriate financial tool to have in the tool box. We have no immediate intentions to utilize the shelf.

Before we turn to the Q&A I wanted to summarize the key points from our call today.

First, our launch of Qutenza is progressing and we are building momentum.

 

13


The key metrics that we touched on today, including the growing numbers of our physicians reached, benefit investigations initiated and resolved, incoming medical inquires from medical professionals as well as patients, all point to the success we are having in raising awareness of Qutenza in the market place and we believe bode well for future quarters.

We intend to continue to execute our total office call approach and focus on establishing the QPRO Centers of Excellence nationwide as we believe this will enable the greatest access for PHN patients to Qutenza in the intermediate term.

Finally, we believe that our continued successful execution of these strategies will position Qutenza to become a very significant product in the long run.

Thanks for your attention; I would now like to open the call up for questions,

Operator?

Q&A Session

Anthony DiTonno: (Wrap-up statement)

As always, thank you for continued interest and support of Neurogesx. These are exciting times as we begin to see our commercialization efforts bear fruit while at the same time preparing to re-enter the clinic with NGX-1998.

I hope you all enjoy what’s left of summer. We look forward to seeing many of you after Labor Day.

 

14

EX-99.3 4 dex993.htm PRESS RELEASE Press Release

Exhibit 99.3

LOGO

 

NeurogesX, Inc.

Stephen Ghiglieri

Executive Vice President, COO

and CFO

(650) 358-3310

  

The Ruth Group

Sara Pellegrino (investors)

(646) 536-7002

spellegrino@theruthgroup.com

 

Jason Rando (media)

(646) 536-7025

jrando@theruthgroup.com

  

NeurogesX Announces Proposed Shelf Registration Statement

San Mateo, Calif., (August 5, 2010) – NeurogesX, Inc. (Nasdaq: NGSX) announced today that on or about the filing date of its upcoming Quarterly Report on Form 10-Q for the quarter ended June 30, 2010, it intends to file a universal shelf registration statement on Form S-3 with the Securities and Exchange Commission (SEC).

This shelf registration statement is planned to give NeurogesX the ability to offer and sell from time to time up to an aggregate of $75,000,000 of its securities, which may consist of common stock, preferred stock, debt securities, warrants, or depositary shares. The terms of any offering under the shelf registration statement will be determined at the time of offering. While NeurogesX does not have any immediate plans to offer securities under this shelf registration, it is intended to give NeurogesX the flexibility to take advantage of financing opportunities as needed or deemed desirable in light of market conditions.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any security and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offering, solicitation or sale would be unlawful. The offering of NeurogesX securities under the universal shelf registration will be made only by means of a prospectus.

About NeurogesX, Inc.

NeurogesX, Inc. (Nasdaq: NGSX) is a San Francisco Bay Area-based biopharmaceutical company focused on developing and commercializing novel pain management therapies. NeurogesX was founded on the concept that use of prescription-strength capsaicin could help manage the pain associated with neuropathic pain conditions. Since its inception, NeurogesX has leveraged its passion to help people with pain to efficiently develop this concept, resulting in the commercial launch of Qutenza® (capsaicin) 8% patch in 2010. The Company continues to apply its knowledge and expertise in the development of other novel treatments for pain.


LOGO

The Company’s lead product, Qutenza, is a localized dermal delivery system containing prescription strength capsaicin that is currently approved in the United States and the European Union. Qutenza is now available in the United States for the management of neuropathic pain associated with postherpetic neuralgia (PHN). In Europe, Qutenza is being marketed by Astellas Pharma Europe Ltd. (Astellas), the European subsidiary of Tokyo-based Astellas Pharma Inc.

The Company’s most advanced product candidate, NGX-1998, is a topically applied liquid formulation containing a high concentration of capsaicin designed to treat pain associated with neuropathic pain conditions such as PHN. NGX-1998 has completed three Phase 1 studies.

The Company’s early-stage product pipeline includes pre-clinical compounds which are prodrugs of acetaminophen and various opioids. The Company has evaluated these compounds in vitro and in vivo.

Safe Harbor Statement

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). NeurogesX disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, statements regarding the timing and intent to file a universal shelf registration statement. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, delays in the filing of the shelf registration statement and management decisions to delay or not proceed with a shelf registration statement filing. For further information regarding these and other risks related to NeurogesX’ business, investors should consult NeurogesX’ filings with the Securities and Exchange Commission.

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-----END PRIVACY-ENHANCED MESSAGE-----