EX-99.2 3 tv488037_ex99-2.htm EXHIBIT 99.2

 

Exhibit 99.2

 

 

Fourth Quarter & Full Year 2017 Results March 8, 2018

 

 

2 Safe Harbor This presentation may include forward - looking statements within the meaning of Section 27 A of the Securities Act of 1933 and Section 21 E of the Securities Exchange Act of 1934 . The words “will,” “may,” “believe,” “expect,” “anticipate,” “estimate,” “project” and similar expressions, and the negatives thereof, identify forward - looking statements, each of which speaks only as of the date the statement is made . Although we believe that our forward - looking statements are based on reasonable assumptions within the bounds of our knowledge of our business and operations, our business is subject to significant risks and as a result there can be no assurance that actual results of our research, development and commercialization activities and our results of operations will not differ materially from the results contemplated in such forward - looking statements . These risks include : ( i ) risks relating to our exchangeable senior notes including use of the net proceeds from the offering of the notes and other future events related to the notes ; (ii) risks relating to the divestiture of our former pediatric business including whether such divestiture will be accretive to our operating income and cash flow ; (iii) risks relating to our license agreement with Serenity Pharmaceuticals, LLC including that our internal analyses may overstate the market opportunity in the United States for the drug desmopressin acetate (the “Drug”) or we may not effectively exploit such market opportunity, that significant safety or drug interaction problems could arise with respect to the Drug, that we may not successfully increase awareness of nocturia and the potential benefits of the Drug, and that the need for management to focus attention on the development and commercialization of the Drug could cause our ongoing business operations to suffer ; and (iv) the other risks, uncertainties and contingencies described in the Company's filings with the U . S . Securities and Exchange Commission, including our annual report on Form 10 - K for the year ended December 31 , 2016 , and our Current Report on Form 8 - K filed on February 14 , 2018 , in particular disclosures that may be set forth in particular under the captions “Forward - Looking Statements” and “Risk Factors,” including without limitation : our dependence on a small number of products and customers for the majority of our revenues ; the possibility that our Bloxiverz ®, Vazculep ® and Akovaz ® products, which are not patent protected, could face substantial competition resulting in a loss of market share or forcing us to reduce the prices we charge for those products ; the possibility that we could fail to successfully complete the research and development for pipeline products we are evaluating for potential application to the FDA pursuant to our "unapproved - to - approved" strategy, or that competitors could complete the development of such products and apply for FDA approval of such products before us ; the possibility that our products may not reach the commercial market or gain market acceptance ; our need to invest substantial sums in research and development in order to remain competitive ; our dependence on certain single providers for development of several of our drug delivery platforms and products ; our dependence on a limited number of suppliers to manufacture our products and to deliver certain raw materials used in our products ; the possibility that our competitors may develop and market technologies or products that are more effective or safer than ours, or obtain regulatory approval and market such technologies or products before we do ; the challenges in protecting the intellectual property underlying our drug delivery platforms and other products ; and our dependence on key personnel to execute our business plan .

 

 

3 Call Outline I. Fourth quarter & full year 2017 overview II. REST - ON Phase III trial update III. FT 218: Pharmacokinetic overview IV. Market update: i. Sodium oxybate use and persistence rates ii. Concomitant use of sodium oxybate and sodium valproate iii. Noctiva ™ V. Q&A

 

 

4 Recent Highlights Financial Overview • 4Q 2017 revenues of $34.2 million & adjusted LPS of $(0.28) • 2017 total revenues of $172.7 million & adjusted EPS of $0.31 • Repurchased $22.3 million of shares • Operating cash flow positive • $137.7 million in net proceeds from convertible offering (2/14/18) Strategic Execution • In - licensed Noctiva ™ in September 2017 • Continued enrollment in REST - ON Phase III trial of FT 218 in narcolepsy patients • Granted Orphan Drug Designation for FT 218 (1/10/18) • Reduced R&D footprint in France • Developed 4 th sterile injectable product • Divested four pediatric products (2/12/18)

 

 

5 Fourth Quarter & Full Year 2017 Financial Results

 

 

6 Non - GAAP Financial Results *Reconciliations from GAAP to Non - GAAP can be found in the appendix (in $000s, except for per share amounts 12/31/17 09/30/17 12/31/16 12/31/17 12/31/16 Total revenue 34,590$ 39,675$ 43,085$ 174,183$ 150,246$ Cost of products and services sold 4,048 3,790 3,610 16,255 12,742 Research and development expenses 12,125 8,095 13,476 34,218 34,611 Selling, general and admin expenses 23,058 11,563 10,688 58,862 44,179 Intangible asset amortization - - - - - Restructuring costs - - - - - Operating expenses 39,231 23,448 27,774 109,335 91,532 Contingent consideration payments and accruals 5,966 7,264 7,645 31,362 26,966 Operating income (loss) (10,607) 8,963 7,666 33,486 31,748 Interest and other income (expense), net (102) 847 294 1,798 672 Other expense - contingent consideration payments and accruals (818) (963) (1,018) (4,246) (3,636) Income (loss) before income taxes (11,527) 8,847 6,942 31,038 28,784 Income tax (benefit) provision (556) 5,100 6,875 18,296 31,373 Net income (loss) (10,971)$ 3,747$ 67$ 12,742$ (2,589)$ Diluted earnings (loss) per share (0.28)$ 0.09$ -$ 0.31$ (0.06)$ Weighted average number of shares outstanding - diluted 39,350 41,339 42,808 41,765 41,248 Three Months Ended Twelve Months Ended (in $000, except for per share amounts)

 

 

7 GAAP Financial Results (in $000s, except for per share amounts 12/31/17 09/30/17 12/31/16 12/31/17 12/31/16 Total revenue 34,248$ 39,675$ 43,085$ 172,741$ 150,246$ Cost of products and services sold 4,048 3,790 2,591 16,301 13,248 Research and development expenses 12,125 8,095 13,476 34,218 34,611 Selling, general and admin expenses 23,058 11,563 10,688 58,862 44,179 Intangible asset amortization 1,967 564 2,970 3,659 13,888 Restructuring costs (631) (549) - 2,542 - Operating expenses 40,567 23,463 29,725 115,582 105,926 (Gain) loss - changes in fair value of related party contingent consideration (1,034) (9,906) (3,704) (31,141) 49,285 Operating income (loss) (5,285) 26,118 17,064 88,300 (4,965) Interest and other income (expense), net (689) 714 1,429 1,084 1,795 Other income (expense) - changes in fair value of related party payable (903) 768 (413) 2,085 (6,548) Income (loss) before income taxes (6,877) 27,600 18,080 91,469 (9,718) Income tax provision 2,385 5,921 13,346 24,215 31,558 Net income (loss) (9,262)$ 21,679$ 4,734$ 67,254$ (41,276)$ Diluted earnings (loss) per share (0.24)$ 0.52$ 0.11$ 1.61$ (1.00)$ Three Months Ended Twelve Months Ended (in $000, except for per share amounts)

 

 

8 Cash Flow Summary in $000's 2017 2016 TOTAL Cash and Marketable Securities Beginning Balance 154,195$ 144,802$ Operating cash flows (excl tax and earnout payments) - base business 86,870 68,801 Noctiva operating spending (15,000) - Earnout/Royalty Payments (37,311) (30,837) Tax Payments (19,143) (27,180) Acquisition of Noctiva Asset (53,111) - Share Repurchases (22,361) - Capital Spending (591) (1,201) Other 527 (190) Change in Total (60,120) 9,393 Ending Balance 94,075$ 154,195$ Twelve Months Ended December 31,

 

 

9 2018 Non - GAAP Guidance 2018 Guidance Current Previous Total Revenues $1 05 M - $1 25 M $1 10 M - $1 30 M Noctiva Revenues $10M - $20M $10M - $20M R&D Expense $ 40 M - $ 50 M $ 40 M - $ 50 M Income Ta x Benefit 0 % - 10 % - Guidance update driven by divestiture of pediatric assets in February 2018

 

 

10 REST - ON Phase III Clinical Update & PK Overview

 

 

11 REST - ON Status Update NDA filing by year end 2018 no longer expected Recent enrollment rate increases are not meeting expectations Activating new clinical sites and increasing patient engagement initiatives to improve screening and enrollment Update on trial to be provided in 2H 2018

 

 

12 Pharmacokinetics: FT 218 vs. Twice - Nightly • 3 FT 218 prototypes at 4.5g vs approved 2 x 2.25g doses • Cmax of FT 218 avoids high peak levels of sodium oxybate associated with second dose • With preferred formulations blood concentration higher first 4 hours with gradual decline • FT 218 similar or lower blood levels to 2x nightly dosing at hour 8 – minimize “ hangover”effect • Similar “onset of action” to 2x - nightly • Identical AUC to 2x - nightly

 

 

13 Pharmacokinetics: FT 218 at 4.5g, 6g & 7.5g Doses • PK for doses at 4.5g, 6g, 7.5g • Consistency and linearity of response as dose increased • Robust and reproducible across dose strengths • Remove inconsistency in timing or missing of second dose

 

 

14 Market Update: Sodium Oxybate & Noctiva ™

 

 

15 Sodium Oxybate: Market Research Highlights 3 - year longitudinal claims analysis & market assessment identifying 262K diagnosed narcolepsy patients Of 262K patients, 194K were treated pharmacologically 19K unique patients (~10%) received 2x - nightly sodium oxybate <1% of 19K patients received sodium valproate ~ 50% of the 19K sodium oxybate users discontinue treatment within 12 months – patients report tolerability & difficulty with dosing

 

 

16 Sodium Oxybate: Market Research Highlights Significant interest from patients in 1x - night given tolerability & dosing Cost assessment: Current & only approved product’s price increased ~1,600% 1 since 2006 Est. 70% of 2x - nightly product revenue increase in last 5 years was price driven, with an est. 30% driven by volume 2 Findings align with multipronged approach to address approval from clinical, regulatory & legal pathways 1) Gold Standard Drug Database 2) Internal estimates

 

 

17 Noctiva ™: Launch Update Accelerated launch >4 weeks ahead of schedule – shipments to wholesalers have begun Patient assistance programs fully operational, including retail & specialty / mail order Fully staffed sales force initiating early access programs & PI launch 4/1/18; Branded launch 5/1 Established Noctiva ™ in own category in 3 major compendia services A primary focus is to secure Part D coverage for 2019 with rollbacks onto 2018 formularies

 

 

18 Question & Answer

 

 

19 Appendix

 

 

20 Revenues by Product (GAAP) in $000's Q1 2017 Q2 2017 Q3 2017 Q4 2017 Full Year 2017 Full Year 2016 Bloxiverz 13,902$ 13,719$ 9,920$ 7,763$ 45,304$ 82,896$ Vazculep 10,179 10,154 9,573 8,140 38,046 39,796 Akovaz 25,638 20,912 18,561 15,435 80,546 16,831 Other 2,038 2,320 1,093 2,990 8,441 7,699 Total product sales and services 51,757$ 47,105$ 39,147$ 34,328$ 172,337$ 147,222$ License and research revenue 750$ (794)$ 528$ (80)$ 404 3,024$ Total revenues 52,507$ 46,311$ 39,675$ 34,248$ 172,741$ 150,246$ (in $000) Products:

 

 

21 GAAP to Non - GAAP Reconciliations: 4Q 2017 Include GAAP Intangible asset amortization Foreign exchange (loss) gain Restructuring impacts License Revenue Adjustment U.S. Federal Tax Law Change Contingent related party payable fair value remeasurements Contingent related party payable paid/accrued Total Adjustments Adjusted GAAP Product sales and services 34,328$ -$ -$ -$ -$ -$ -$ -$ -$ 34,328$ License and research revenue (80) - - - 342 - - - 342 262 Total revenue 34,248 - - - 342 - - - 342 34,590 - - - - - - - Cost of products and services sold 4,048 - - - - - - - - 4,048 Research and development expenses 12,125 - - - - - - - - 12,125 Selling, general and administrative expenses 23,058 - - - - - - - - 23,058 Intangible asset amortization 1,967 (1,967) - - - - - - (1,967) - Changes in fair value of related party contingent consideration (1,034) - - - - - 1,034 5,966 7,000 5,966 Restructuring costs (631) - - 631 - - - - 631 - Total operating expenses 39,533 (1,967) - 631 - - 1,034 5,966 5,664 45,197 Operating income (loss) (5,285) 1,967 - (631) 342 - (1,034) (5,966) (5,322) (10,607) - - - - - - - Investment Income 161 - - - - - - - - 161 Interest Expense (263) - - - - - - - - (263) Other Expense - changes in fair value of related party payable (903) - - - - - 903 (818) 85 (818) Foreign exchange (loss) gain (587) - 587 - - - - - 587 - - - - - - - - Income (loss) before income taxes (6,877) 1,967 587 (631) 342 - (131) (6,784) (4,650) (11,527) Income tax provision (benefit) 2,385 706 - - - (3,513) 299 (433) (2,941) (556) Net (loss) income (9,262)$ 1,261$ 587$ (631)$ 342$ 3,513$ (430)$ (6,351)$ (1,709)$ (10,971)$ Net (loss) income per share - diluted (0.24)$ 0.03$ 0.01$ (0.02)$ 0.01$ 0.09$ (0.01)$ (0.15)$ (0.04)$ (0.28)$ Weighted average number of shares outstanding - Diluted 39,350 39,350 39,350 39,350 39,350 39,350 39,350 39,350 39,350 39,350 Exclude GAAP to Non-GAAP adjustments for the three months ended December 31, 2017

 

 

22 GAAP to Non - GAAP Reconciliations: 3Q 2017 Include GAAP Intangible asset amortization Foreign exchange (loss) gain Cross-border merger impacts Purchase accounting adjustments - FSC Contingent related party payable fair value remeasurements Contingent related party payable paid/accrued Total Adjustments Adjusted GAAP Product sales and services 42,364$ -$ -$ -$ -$ -$ -$ -$ 42,364$ License and research revenue 721 - - - - - - - 721 Total revenue 43,085 - - - - - - - 43,085 Cost of products and services sold 2,591 - - - 1,019 - - 1,019 3,610 Research and development expenses 13,476 - - - - - - - 13,476 Selling, general and administrative expenses 10,688 - - - - - - - 10,688 Intangible asset amortization 2,970 (2,970) - - - - - (2,970) - Changes in fair value of related party contingent consideration (3,704) - - - - 3,704 7,645 11,349 7,645 Restructuring costs - - - - - - - - - Total operating expenses 26,021 (2,970) - - 1,019 3,704 7,645 9,398 35,419 Operating income (loss) 17,064 2,970 - - (1,019) (3,704) (7,645) (9,398) 7,666 Investment Income 555 - - - - - - - 555 Interest Expense (261) - - - - - - - (261) Other Expense - changes in fair value of related party payable (413) - - - - 413 (1,018) (605) (1,018) Foreign exchange (loss) gain 1,135 - (1,135) - - - - (1,135) - Income (loss) before income taxes 18,080 2,970 (1,135) - (1,019) (3,291) (8,663) (11,138) 6,942 Income tax provision (benefit) 13,346 1,066 - (6,754) (366) 82 (499) (6,471) 6,875 Net income (loss) 4,734$ 1,904$ (1,135)$ 6,754$ (653)$ (3,373)$ (8,164)$ (4,667)$ 67$ Net income (loss) per share - diluted 0.11$ 0.04$ (0.03)$ 0.16$ (0.02)$ (0.08)$ (0.19)$ (0.11)$ -$ Weighted average number of shares outstanding - Diluted 42,808 42,808 42,808 42,808 42,808 42,808 42,808 42,808 42,808 Exclude GAAP to Non-GAAP adjustments for the three months ended December 31, 2016

 

 

23 GAAP to Non - GAAP Reconciliations: 4Q 2016 Include GAAP Intangible asset amortization Foreign exchange (loss) gain Cross-border merger impacts Purchase accounting adjustments - FSC Contingent related party payable fair value remeasurements Contingent related party payable paid/accrued Total Adjustments Adjusted GAAP Product sales and services 42,364$ -$ -$ -$ -$ -$ -$ -$ 42,364$ License and research revenue 721 - - - - - - - 721 Total revenue 43,085 - - - - - - - 43,085 Cost of products and services sold 2,591 - - - 1,019 - - 1,019 3,610 Research and development expenses 13,476 - - - - - - - 13,476 Selling, general and administrative expenses 10,688 - - - - - - - 10,688 Intangible asset amortization 2,970 (2,970) - - - - - (2,970) - Changes in fair value of related party contingent consideration (3,704) - - - - 3,704 7,645 11,349 7,645 Restructuring costs - - - - - - - - - Total operating expenses 26,021 (2,970) - - 1,019 3,704 7,645 9,398 35,419 Operating income (loss) 17,064 2,970 - - (1,019) (3,704) (7,645) (9,398) 7,666 Investment Income 555 - - - - - - - 555 Interest Expense (261) - - - - - - - (261) Other Expense - changes in fair value of related party payable (413) - - - - 413 (1,018) (605) (1,018) Foreign exchange (loss) gain 1,135 - (1,135) - - - - (1,135) - Income (loss) before income taxes 18,080 2,970 (1,135) - (1,019) (3,291) (8,663) (11,138) 6,942 Income tax provision (benefit) 13,346 1,066 - (6,754) (366) 82 (499) (6,471) 6,875 Net income (loss) 4,734$ 1,904$ (1,135)$ 6,754$ (653)$ (3,373)$ (8,164)$ (4,667)$ 67$ Net income (loss) per share - diluted 0.11$ 0.04$ (0.03)$ 0.16$ (0.02)$ (0.08)$ (0.19)$ (0.11)$ -$ Weighted average number of shares outstanding - Diluted 42,808 42,808 42,808 42,808 42,808 42,808 42,808 42,808 42,808 Exclude GAAP to Non-GAAP adjustments for the three months ended December 31, 2016

 

 

24 GAAP to Non - GAAP Reconciliations: FY 2017 Include GAAP Intangible asset amortization Foreign exchange (loss) gain Restructuring impacts Purchase accounting adjustments - FSC License Revenue Adjustment U.S. Federal Tax Law Change Contingent related party payable fair value remeasurements Contingent related party payable paid/accrued Total Adjustments Adjusted GAAP Product sales and services 172,337$ -$ -$ -$ -$ -$ -$ -$ -$ -$ 172,337$ License and research revenue 404 - - - - 1,442 - - - 1,442 1,846 Total revenue 172,741 - - - - 1,442 - - - 1,442 174,183 Cost of products and services sold 16,301 - - - (46) - - - - (46) 16,255 Research and development expenses 34,218 - - - - - - - - - 34,218 Selling, general and administrative expenses 58,862 - - - - - - - - - 58,862 Intangible asset amortization 3,659 (3,659) - - - - - - - (3,659) - Changes in fair value of related party contingent consideration (31,141) - - - - - - 31,141 31,362 62,503 31,362 Restructuring costs 2,542 - - (2,542) - - - - - (2,542) - Total operating expenses 84,441 (3,659) - (2,542) (46) - - 31,141 31,362 56,256 140,697 Operating income (loss) 88,300 3,659 - 2,542 46 1,442 - (31,141) (31,362) (54,814) 33,486 Investment Income 2,850 - - - - - - - - - 2,850 Interest Expense (1,052) - - - - - - - - - (1,052) Other Expense - changes in fair value of related party payable 2,085 - - - - - - (2,085) (4,246) (6,331) (4,246) Foreign exchange (loss) gain (714) - 714 - - - - - - 714 - - - - - - - - - Income (loss) before income taxes 91,469 3,659 714 2,542 46 1,442 - (33,226) (35,608) (60,431) 31,038 Income tax provision (benefit) 24,215 1,309 - - 17 - (3,513) (1,477) (2,255) (5,919) 18,296 Net income (loss) 67,254$ 2,350$ 714$ 2,542$ 29$ 1,442$ 3,513$ (31,749)$ (33,353)$ (54,512)$ 12,742$ Net income (loss) per share - diluted 1.61$ 0.06$ 0.02$ 0.06$ -$ 0.03$ 0.08$ (0.76)$ (0.80)$ (1.31)$ 0.31$ Weighted average number of shares outstanding - Diluted 41,765 41,765 41,765 41,765 41,765 41,765 41,765 41,765 41,765 41,765 41,765 Exclude GAAP to Non-GAAP adjustments for the twelve months ended December 31, 2017

 

 

25 GAAP to Non - GAAP Reconciliations: FY 2016 Include GAAP IntAIgible asset amortization Foreign exchange (loss) gain Cross-border merger impacts Purchase accounting adjustments - FSC Contingent related party payable fair value remeasurements Contingent related party payable paid/accrued Total Adjustments Adjusted GAAP Product sales and services 147,222$ -$ -$ -$ -$ -$ -$ -$ 147,222$ License and research revenue 3,024 - - - - - - - 3,024 Total revenue 150,246 - - - - - - - 150,246 Cost of products and services sold 13,248 - - - (506) - - (506) 12,742 Research and development expenses 34,611 - - - - - - - 34,611 Selling, general and administrative expenses 44,179 - - - - - - - 44,179 Intangible asset amortization 13,888 (13,888) - - - - - (13,888) - Changes in fair value of related party contingent consideration 49,285 - - - - (49,285) 26,966 (22,319) 26,966 Restructuring costs - - - - - - - - - Total operating income (expenses) 155,211 (13,888) - - (506) (49,285) 26,966 (36,713) 118,498 Operating income (loss) (4,965) 13,888 - - 506 49,285 (26,966) 36,713 31,748 Investment Income 1,635 - - - - - - - 1,635 Interest Expense (963) - - - - - - - (963) Other Expense - changes in fair value of related party payable (6,548) - - - - 6,548 (3,636) 2,912 (3,636) Foreign exchange (loss) gain 1,123 - (1,123) - - - - (1,123) - Income (loss) before income taxes (9,718) 13,888 (1,123) - 506 55,833 (30,602) 38,502 28,784 Income tax provision (benefit) 31,558 4,986 - (6,754) 182 3,068 (1,667) (185) 31,373 Net income (loss) (41,276)$ 8,902$ (1,123)$ 6,754$ 324$ 52,765$ (28,935)$ 38,687$ (2,589)$ Net income (loss) per share - diluted (1.00)$ 0.22$ (0.03)$ 0.16$ 0.01$ 1.28$ (0.70)$ 0.94$ (0.06)$ Weighted average number of shares outstanding - Diluted 41,248 41,248 41,248 41,248 41,248 41,248 41,248 41,248 41,248 Exclude GAAP to Non-GAAP adjustments for the twelve months ended December 31, 2016