Document
false0001356576 0001356576 2019-11-05 2019-11-05


 
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): November 5, 2019
 
Supernus Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)

Delaware
001-35518
20-2590184
 
(State or other jurisdiction of incorporation or organization)
(Commission File Number)
(I.R.S. Employer Identification No.)
 
 
 
1550 East Gude Drive
Rockville
MD
20850
 
(Address of Principal Executive Offices)
 
(Zip Code)
 

 
Registrant’s telephone number, including area code: (301) 838-2500
 
Not Applicable
(Former name or former address, if changed since last report.)

  Securities registered pursuant to Section 12(b) of the Exchange Act
Title of each class
Trading Symbol
Name of each exchange on which registered
Common Stock, $0.001 par value per share
SUPN
The Nasdaq Global Market

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))
 
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).
 
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.
 

1



Item 2.02                                           Results of Operations and Financial Condition.

On November 5, 2019, Supernus Pharmaceuticals, Inc. (“Supernus” or the “Company”) issued a press release regarding its financial results for the third quarter ended September 30, 2019. A copy of this press release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.

As previously announced, Supernus will host a conference call at 9:00 a.m. Eastern Time on Wednesday, November 6, 2019, to present the business and financial results. A live webcast will be available at www.supernus.com. The webcast will be archived on the Company’s website for 60 days following the live call. Callers should dial in approximately 10 minutes prior to the start of the call. The phone number to join the conference call is +1 (877) 288-1043 (U.S. and Canada) or +1 (970) 315-0267 (international). The access code for the live call is 8278897.

The information in this Item 2.02 (including Exhibit 99.1) is being “furnished” and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, whether made before or after the date of this report, except as shall be expressly set forth by specific reference in such filing.

Item 8.01                                           Other Events.
 
On November 5, 2019, the Company issued a press release announcing the topline results from one of its Phase III studies of SPN-810 for the treatment of Impulsive Aggression ("IA") in attention deficit hyperactivity disorder (“ADHD”) patients 6 to 11 years old. The Phase III P301 trial in patients 6 to 11 years old did not meet its primary endpoint. The study was a randomized, double-blind, placebo controlled, multicenter, parallel group clinical trial in patients diagnosed with ADHD. Patients receiving SPN-810 36 mg showed a median percent reduction in the average weekly frequency of impulsive aggression episodes from baseline that was not statistically significant compared to placebo. These results are based on the combined analysis of data from stage 1 (interim analysis stage) and stage 2 (post interim analysis stage) in the study. In stage 1, the median percent reduction was statistically significant compared to placebo. However, in stage 2 of the study, post the interim analysis, the increase in variability in the 36mg treatment arm seems to have adversely impacted the results in the combined analysis. The median percent reduction in frequency of IA behavior in this Phase III study is consistent with the range of percent improvement in the retrospective modified aggression scale in the two positive treatment arms in the Phase IIb study.

Overall, the trial exhibited favorable tolerability and safety profiles with low incidence of adverse events (AEs) across all doses. AEs were mild leading to low discontinuance rates for the 18mg, 36mg and combined treatment arms, respectively.

The Company will stop enrollment in the Phase III P302 trial in patients 6 to 11 years old and analyze the data, which is expected to be available by the end of 2019. In the meantime, enrollment in the P503 Phase III trial (adolescents) is on hold until data from the P302 study are available and a final decision is reached regarding the SPN-810 program in IA. A copy of this press release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.

This Current Report on Form 8-K contains “forward-looking statements” that do not convey historical information, but relate to predicted or potential future events, such as statements of our plans, strategies and intentions. These statements can often be identified by the use of forward-looking terminology such as “believe,” “expect,” “intend,” “may,” “will,” “should,” or “anticipate” or similar terminology. All statements other than statements of historical facts included in this Current Report on Form 8-K are forward-looking statements. All forward-looking statements speak only as of the date of this Current Report on Form 8-K. Except for Supernus’ ongoing obligations to disclose material information under the federal securities laws, Supernus undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. In addition to the risks and uncertainties of ordinary business operations and conditions in the general economy and the markets in which Supernus competes, the forward-looking statements of Supernus contained in this Current Report on Form 8-K are also subject to various risks and uncertainties, including those set forth in Item 1A, “Risk Factors,” in Supernus’ Annual Report on Form 10-K for the fiscal year ended December 31, 2018, which the Company filed on March 1, 2019.


2



 
Item 9.01                                           Financial Statements and Exhibits*.
 
(d)                                 Exhibit
 
The following document is furnished as an Exhibit pursuant to Item 2.02 hereof:
 
Exhibit 99.1 — Press Release Dated November 5, 2019.

Exhibit 104 — The cover page from this Current Report on Form 8-K, formatted in Inline XBRL.

______________________________________

* The information furnished under Item 2.02 and item 9.01 of this Current Report on Form 8-K, including the exhibits, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange act of 1934, as amended, or otherwise subject to liabilities under that section, nor shall it be deemed incorporated by reference in any registration statement or other filings of the Company under the Securities act of 1933, as amended, except as shall be set forth by specific reference in such filing.

3



EXHIBIT INDEX
 
Number
 
Description
 
 
 
 
 
 
 
99.1
 
 
Attached

4



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. 
 
SUPERNUS PHARMACEUTICALS, INC.
 
 
DATED: November 6, 2019
By:
/s/ Gregory S. Patrick
 
 
Gregory S. Patrick
 
 
Senior Vice-President and Chief Financial Officer


5
Exhibit


Exhibit 99.1
 http://api.tenkwizard.com/cgi/image?quest=1&rid=23&ipage=13185936&doc=8
 

Supernus Announces Third Quarter 2019 Financial Results and Topline Data from
Phase III Study of SPN-810 for Treatment of Impulsive Aggression (IA) in ADHD Patients


Total revenue of $102.1 million, compared to $103.0 million in third quarter 2018
Net product sales of $100.0 million, compared to $100.2 million in third quarter 2018
Operating earnings of $39.7 million, compared to $37.5 million in third quarter 2018
NDA submission for SPN-812 expected in November 2019
Phase III P301 trial of SPN-810 for the treatment of IA in ADHD patients 6 to 11 years old did not meet its primary endpoint

ROCKVILLE, Md., November 5, 2019 - Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today reported financial results for the third quarter of 2019, results from the Phase III P301 trial for SPN-810 and associated Company developments.
Commercial Update
Third quarter 2019 product prescriptions for Trokendi XR® and Oxtellar XR®, as reported by IQVIA, totaled 215,033, a 6.4% increase over the third quarter of 2018.
 
Prescriptions
 
 
 
Q3 2019

 
Q3 2018

 
Change %

Trokendi XR
172,981

 
164,689

 
5.0
%
Oxtellar XR
42,052

 
37,476

 
12.2
%
Total
215,033

 
202,165

 
6.4
%
Source: IQVIA
Net product sales for the third quarter of 2019 were $100.0 million, compared to $100.2 million in the third quarter of 2018. Net product sales by product are as follows:

Net Product Sales
($ in thousands)
 
Q3 2019

 
Q3 2018

 
Change %

Trokendi XR
$
77,332

 
$
79,834

 
(3.1
)%
Oxtellar XR
22,702

 
20,393

 
11.3
 %
Total
$
100,034

 
$
100,227

 
(0.2
)%
“For the quarter and year to date periods, the beneficial impact of volume growth and price increases has been offset by continued pressure on gross-to-net sales deductions,” said Jack Khattar, President and CEO of Supernus. “Going forward, we believe that competitive dynamics and pressure on gross-to-net deductions are not likely to abate; consequently, we believe that net product sales growth will essentially be flat, even with moderate growth in prescriptions.”






Progress of Product Pipeline
SPN-812 - Novel non-stimulant for the treatment of ADHD
The Company expects to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for SPN-812 for the treatment of ADHD in November 2019.
A Phase III program in adult patients was initiated during the third quarter of 2019.

SPN-810 - Novel treatment of Impulsive Aggression (IA) in patients with ADHD
Phase III P301 trial in patients 6 to 11 years old did not meet its primary endpoint. The study was a randomized, double-blind, placebo controlled, multicenter, parallel group clinical trial in patients diagnosed with ADHD. Patients receiving SPN-810 36mg showed a median percent reduction of 58.6% in the average weekly frequency of impulsive aggression episodes from baseline that was not statistically significant (p= 0.092) compared to placebo. These results are based on the combined analysis of data from stages 1 and 2 in the study. In stage 1 (interim analysis stage), the median percent reduction was 60%, which was statistically significant (p= 0.029) compared to placebo. However, in stage 2 of the study, post the interim analysis, the increase in variability in the 36mg treatment arm seems to have adversely impacted the results in the combined analysis.

Percent Change from Baseline (CFB) in the Frequency of IA Behaviors
Treatment Period - Primary Analysis (ITT Population)

Stage 1 - % CFB
Placebo
SPN-810
18mg
 
SPN-810
36mg
 
   N
52
49
45
   Mean (SD)
-42.9 (35.9)
-45.8 (33.5)
-56.6 (34.1)
   Median
-48.6
-47.8
-60.0
   P-value
 
0.651
0.029
Stage 2 - % CFB
 
 
 
   N
73
16
90
   Mean (SD)
-43.8 (36.3)
-44.5 (34.6)
-44.0 (43.5)
   Median
-47.2
-45.6
-58.5
   P-value
 
 
0.102
Stages 1 & 2 Combined - % CFB
 
 
 
   N
125
65
135
   Mean (SD)
-43.4 (36.0)
-45.5 (33.5)
-48.2 (40.9)
   Median
-48.2
-47.9
-58.6
   P-value
 
0.714
0.092

The median percent reduction in frequency of IA behavior in this Phase III study is consistent with the range of percent improvement in the retrospective modified aggression scale (58% - 62%) we saw in the two positive treatment arms in the Phase IIb study. The Company will continue its analysis of the results to better understand the reasons behind the increased variability in the 36mg treatment arm in the P301 study.

Overall, the trial exhibited favorable tolerability and safety profiles with low incidence of adverse events (AEs) across all doses. AEs were mild leading to low discontinuation rates of 0%, 7% and 5% for the 18mg, 36mg and combined treatment arms, respectively.





    
Adverse Event (AE)
N (%)
Placebo
(N=126)
SPN-810 18mg
(N=65)
SPN-810 36mg (N=137)
SPN-810 Combined (N=202)
Fatigue
1 (0.8)
2 (3.1)
10 (7.3)
12 (5.9)
Headache
2 (1.6)
2 (3.1)
7 (5.1)
9 (4.5)
Increased Appetite
6 (4.8)
0
9 (6.6)
9 (4.5)
Blood Prolactin Increased
1 (0.8)
4 (6.2)
2 (1.5)
6 (3.0)
Upper Respiratory Tract Infection
8 (6.3)
2 (3.1)
2 (1.5)
4 (2.0)
 
 
 
 
 
Discontinuation Rate due to AE’s
4 (3.1)
0 (0)
10 (7.2)
10 (4.9)

Enrollment in the Phase III P302 trial in patients 6 to 11 years old is at 98% of the target. The Company will cease enrollment in the P302 trial and analyze the data, which are expected to be available by the end of 2019. In the meantime, enrollment in the P503 Phase III trial (adolescents) is on hold until data from the P302 study are available and a final decision is reached regarding the SPN-810 program in IA. Mr. Khattar added, “We are obviously disappointed with the efficacy results from our Phase III P301 trial with SPN-810. I thank all our employees for working diligently to complete the studies and believing in what we do for our patients. I also thank all our patients, their families, and our investigators for participating in our studies.”

SPN-604 - Novel treatment of bipolar disorder
The Company initiated a pivotal Phase III monotherapy trial for the treatment of bipolar disorder in the fourth quarter of 2019.

Operating Expenses
Research and development (R&D) expenses in the third quarter of 2019 were $16.9 million, lower than the $20.4 million in the same quarter last year. This decrease is due to the completion of the four Phase III clinical trials for SPN-812, three of which were completed in December 2018 and one of which was completed in March 2019. These reductions were partially offset by SPN-812 manufacturing costs in support of the Company’s NDA submission.
Selling, general and administrative (SG&A) expenses in the third quarter of 2019 were $40.6 million, essentially unchanged from $40.9 million in the same quarter last year.
Operating Earnings and Earnings Per Share
Operating earnings in the third quarter of 2019 were $39.7 million, a 5.9% increase from $37.5 million in the same quarter last year. The increase in operating earnings was primarily due to lower R&D expenses in the third quarter of 2019.
Net earnings (GAAP) in the third quarter of 2019 were $28.9 million, or $0.54 per diluted share, compared to $28.0 million, or $0.52 per diluted share, in the same period last year. Growth in operating earnings was offset by a modestly higher effective tax rate in the third quarter of 2019 compared to the year earlier period (27.1% compared to 23.0%), resulting in net earnings in the third quarter of 2019 that were comparable to net earnings in third quarter 2018.

Weighted-average diluted common shares outstanding were approximately 53.8 million in the third quarter of 2019, as compared to approximately 54.2 million in the prior year period.

Balance Sheet Highlights
As of September 30, 2019, the Company had $893.1 million in cash, cash equivalents, marketable securities and long term marketable securities, compared to $774.8 million at December 31, 2018. This increase primarily reflects cash generated from operations in the first nine months of 2019.






Financial Guidance
The Company is revising its full year 2019 guidance for net product sales, R&D expenses and operating earnings, and reaffirming expectations for the effective tax rate as set forth below:
Net product sales in the range of $390 million to $395 million, compared to the previously expected range of $400 million to $410 million.
R&D expenses of approximately $70 million, compared to the previously expected range of $70 million to $80 million.
Operating earnings in the range of $150 million to $155 million, compared to the previously expected range of $150 million to $160 million.
Effective tax rate of approximately 23% to 25%.

Looking forward to 2020, the Company expects that the combined impact of product unit volume growth and price increases will be offset by continued pressure on gross-to-net sales deductions. In addition, the Company expects to launch SPN-812 in the second half of 2020. As such, the Company expects SG&A expenses to exceed $200 million for 2020, driven by pre-launch and launch marketing expenses, as well as the impact of fielding the psychiatry sales force in the second half of the year. Finally, R&D expenses are expected to be comparable to 2019.
Conference Call Details
The Company will hold a conference call hosted by Jack Khattar, President and Chief Executive Officer, and Greg Patrick, Senior Vice President and Chief Financial Officer, to discuss these results at 9:00 a.m. Eastern Time, on Wednesday, November 6, 2019.
Please refer to the information below for conference call dial-in information and webcast registration. Callers should dial in approximately 10 minutes prior to the start of the call.
Conference dial-in:
(877) 288-1043
International dial-in:
(970) 315-0267
Conference ID:
8278897
Conference Call Name:
Supernus Pharmaceuticals Third Quarter 2019 Earnings Conference Call
 
Following the live call, a replay will be available on the Company's website, www.supernus.com, under “Investor Relations”.

About Supernus Pharmaceuticals, Inc.
 
Supernus Pharmaceuticals, Inc. is a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. The Company currently markets Trokendi XR® (extended-release topiramate) for the prophylaxis of migraine and the treatment of epilepsy, and Oxtellar XR® (extended-release oxcarbazepine) for the treatment of epilepsy. The Company is also developing several product candidates to address large market opportunities in the CNS market, including SPN-812 for the treatment of ADHD and SPN-604 for the treatment of bipolar disorder.





Forward-Looking Statements:
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not convey historical information, but relate to predicted or potential future events that are based upon management's current expectations. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In addition to the factors mentioned in this press release, such risks and uncertainties include, but are not limited to, the Company’s ability to sustain and increase its profitability; the Company’s ability to raise sufficient capital to fully implement its corporate strategy; the implementation of the Company’s corporate strategy; the Company’s future financial performance and projected expenditures; the Company’s ability to increase the number of prescriptions written for each of its products; the Company’s ability to increase its net revenue; the Company’s ability to enter into future collaborations with pharmaceutical companies and academic institutions or to obtain funding from government agencies; the Company’s product research and development activities, including the timing and progress of the Company’s clinical trials, and projected expenditures; the Company’s ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company’s product candidates; the Company’s ability to protect its intellectual property and operate its business without infringing upon the intellectual property rights of others; the Company’s expectations regarding federal, state and foreign regulatory requirements; the therapeutic benefits, effectiveness and safety of the Company’s product candidates; the accuracy of the Company’s estimates of the size and characteristics of the markets that may be addressed by its product candidates; the Company’s ability to increase its manufacturing capabilities for its products and product candidates; the Company’s projected markets and growth in markets; the Company’s product formulations and patient needs and potential funding sources; the Company’s staffing needs; and other risk factors set forth from time to time in the Company’s filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. The Company undertakes no obligation to update the information in this press release to reflect events or circumstances after the date hereof or to reflect the occurrence of anticipated or unanticipated events.
















Supernus Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share data)
 
September 30,
 
December 31,
 
2019
 
2018
 
(unaudited)
 
 
Assets
 
 
 
Current assets
 
 
 
Cash and cash equivalents
$
116,889

 
$
192,248

Marketable securities
179,808

 
163,770

Accounts receivable, net
86,699

 
102,922

Inventories, net
25,504

 
25,659

Prepaid expenses and other current assets
18,182

 
8,888

Total current assets
427,082

 
493,487

Long term marketable securities
596,442

 
418,798

Property and equipment, net
9,977

 
4,095

Intangible assets, net
26,101

 
31,368

Lease assets
18,780

 

Deferred income taxes
27,953

 
29,683

Other assets
574

 
380

 
 
 
 
Total assets
$
1,106,909

 
$
977,811

 
 
 
 
Liabilities and stockholders’ equity
 
 
 
Current liabilities
 
 
 
Accounts payable
$
3,090

 
$
3,195

Accrued product returns and rebates
98,050

 
107,063

Accrued expenses and other current liabilities
40,800

 
36,535

Income taxes payable
4,818

 
12,377

Nonrecourse liability related to sale of future royalties, current portion
2,959

 
2,183

Total current liabilities
149,717

 
161,353

Convertible notes, net
341,163

 
329,462

Nonrecourse liability related to sale of future royalties, long term
20,305

 
22,575

Lease liabilities, long term
27,256

 

Other liabilities
11,211

 
11,398

Total liabilities
549,652

 
524,788

 
 
 
 
Stockholders’ equity
 
 
 
Common stock, $0.001 par value; 130,000,000 shares authorized; 52,462,936 and 52,316,583 shares issued and outstanding as of September 30, 2019 and December 31, 2018, respectively
52

 
52

Additional paid-in capital
383,525

 
369,637

Accumulated other comprehensive earnings (loss), net of tax
7,261

 
(3,158
)
Retained earnings
166,419

 
86,492

Total stockholders’ equity
557,257

 
453,023

 
 
 
 
Total liabilities and stockholders’ equity
$
1,106,909

 
$
977,811








Supernus Pharmaceuticals, Inc.
Condensed Consolidated Statements of Earnings
(in thousands, except share and per share data)
 
Three Months ended September 30,
 
Nine Months ended
September 30,
 
2019
 
2018
 
2019
 
2018
 
(unaudited)
 
(unaudited)
Revenues
 
 
 
 
 
 
 
Net product sales
$
100,034

 
$
100,227

 
$
285,491

 
$
286,377

Royalty revenues
2,106

 
2,769

 
6,818

 
5,836

Licensing revenues

 

 

 
750

Total revenues
102,140

 
102,996

 
292,309

 
292,963

 
 
 
 
 
 
 
 
Costs and expenses
 
 
 
 
 
 
 
Cost of goods sold
4,819

 
4,207

 
12,547

 
11,168

Research and development
16,943

 
20,422

 
49,307

 
59,368

Selling, general and administrative
40,649

 
40,892

 
122,700

 
117,838

 
 
 
 
 
 
 
 
Total costs and expenses
62,411

 
65,521

 
184,554

 
188,374

 
 
 
 
 
 
 
 
Operating earnings
39,729

 
37,475

 
107,755

 
104,589

 
 
 
 
 
 
 
 
Other income (expenses), net
(139
)
 
(1,104
)
 
(1,180
)
 
(3,180
)
 
 
 
 
 
 
 
 
Earnings before income taxes
39,590

 
36,371

 
106,575

 
101,409

 
 
 
 
 
 
 
 
Income tax expense
10,730

 
8,360

 
26,648

 
16,309

Net earnings
$
28,860

 
$
28,011

 
$
79,927

 
$
85,100

 
 
 
 
 
 
 
 
Earnings per share
 
 
 
 
 
 
 
Basic
$
0.55

 
$
0.54

 
$
1.53

 
$
1.64

Diluted
$
0.54

 
$
0.52

 
$
1.48

 
$
1.57

 
 
 
 
 
 
 
 
Weighted-average shares outstanding
 
 
 
 
 
 
 
Basic
52,453,384

 
52,227,630

 
52,392,232

 
51,897,240

Diluted
53,805,838

 
54,239,847

 
53,898,486

 
54,098,330

 
 
 
 
 
 
 
 






CONTACTS:

Jack A. Khattar, President and CEO
Gregory S. Patrick, Senior Vice President and CFO
Supernus Pharmaceuticals, Inc.
Tel: (301) 838-2591

or

INVESTOR CONTACT:
Peter Vozzo
Westwicke, an ICR Company
Office: (443) 213-0505
Mobile: (443) 377-4767
Email: peter.vozzo@westwicke.com