CAMBREX REPORTS FOURTH QUARTER AND FULL YEAR 2018

On February 13, 2019 Cambrex Corporation (NYSE: CBM), a leading provider of development, manufacturing, testing and technology services for small molecules, reported results for the fourth quarter and full year ended December 31, 2018 (Press release, Cambrex, FEB 13, 2019, View Source [SID1234533274]).

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Fourth Quarter 2018 Highlights

Announced the acquisition of Avista Pharma Solutions ("Avista"), an early clinical phase Contract Development, Manufacturing and Testing Organization, for approximately $252 million in total cash consideration. This transaction closed on January 2, 2019.

Net revenue was $134.3 million under current U.S. GAAP, ASC 606 ("ASC 606"). Under ASC 605, the previous revenue recognition standard, and the only standard under which fourth quarter 2017 results were reported, Net revenue increased 16% compared to the same quarter last year.

Under current U.S. GAAP, Income from continuing operations was $1.3 million and Diluted EPS was $0.04 per share. This reflects the impacts of the timing of certain tax charges related to tax reform in New Jersey. Under previous U.S. GAAP utilizing ASC 605, Income from continuing operations would have been $32.3 million and Diluted EPS from continuing operations would have been $0.96 per share compared to Income from continuing operations of $40.2 million and Diluted EPS of $1.20 in the same quarter last year. Adjusted Income from continuing operations was $48.7 million and Diluted EPS was $1.44, compared to $42.3 million and $1.26, respectively, for the same quarter last year (see table at the end of this press release).

Under ASC 606, EBITDA was $33.5 million. Adjusted EBITDA, which excludes the impact of adopting ASC 606, Halo’s results and Acquisition and Integration costs, was $70.7 million compared to $65.1 million in the same quarter last year (see table at the end of this press release).

Net debt was $204.1 million at the end of the quarter, a decrease of $23.7 million during the quarter primarily driven by cash flows from operations.

The Company expects full year 2019 Net revenue, which excludes the impact of foreign currency, to be between 21% and 25% higher than 2018 Net revenue as recorded under ASC 606 for both years. Adjusted EBITDA is expected to be between $150 and $160 million (see Financial Expectations – Continuing Operations section below for related explanations and additional financial guidance).

"We’re very excited to add the early stage development and testing capabilities of Avista Pharma, which when added to the drug product capabilities of Halo Pharma, which we acquired a few months ago, and Cambrex’s legacy drug substance capabilities, makes us a leading global provider of end to end integrated services for small molecules. Combining Cambrex, Halo and Avista will allow us to follow a small molecule from pre-clinical through commercialization and leverage hundreds of new customers and molecule opportunities across a much broader services and manufacturing platform. Integration efforts are well under way with the goal of building a best-in-class fully integrated contract development and manufacturing organization," commented Steven M. Klosk, President and Chief Executive Officer of Cambrex.

"Looking forward, we continue to see strong market conditions in the sectors that we serve. This is especially true in early stage development and testing, where we expect continued strong growth, creating the potential for a large funnel of molecules for which we hope to deliver a broad range of services all the way through commercial approval."

Basis of Reporting

The Company has provided a reconciliation of GAAP to adjusted (i.e. Non-GAAP) amounts at the end of this press release. Cambrex management believes that the adjustments provide useful information to investors due to the magnitude and nature of certain amounts recorded under GAAP.

Fourth Quarter 2018 Operating Results – Consolidated, Continuing Operations

Net revenue under ASC 606 was $134.3 million. Under ASC 605, the revenue recognition standard for which 2017 results were reported, Net revenue increased to $212.3 million, or 16%, from $182.3 million in the same quarter last year. Results under ASC 605 include a 2% unfavorable impact of foreign exchange compared to the fourth quarter of 2017. Net revenue during the fourth quarter of 2018 includes the acquisition of Halo, now our finished dosage form segment, which contributed revenue of $23.4 million under ASC 606 and $23.2 million under ASC 605. Excluding finished dosage form Net revenues, higher sales of controlled substances was the primary driver of the increase under ASC 605 compared to the same quarter last year.

Gross margin under ASC 606 was 36% for the fourth quarter of 2018. Under ASC 605, Gross margin was 41% compared to 43% in the same quarter last year. Excluding the finished dosage form segment and the unfavorable impact of foreign exchange, ASC 605 Gross margin during the quarter was 42%.

Selling, general and administrative expenses were $21.5 million, compared to $18.3 million in the same quarter last year. The increase was mainly due to higher amortization expense related to purchased intangible assets of $3.0 million within the finished dosage form segment.

Research and development expenses were $3.6 million, compared to $4.3 million in the same quarter last year. The decrease is primarily due to lower expenses related to the development of generic drug products.

Acquisition and Integration expenses of $3.4 million for the fourth quarter of 2018 represent costs associated with the acquisitions of Halo and Avista. The acquisition of Avista closed on January 2, 2019.

Operating profit under ASC 606 was $19.8 million for the fourth quarter of 2018. Under ASC 605, Operating profit was $58.8 million compared to $56.3 million in the same quarter last year. The increase was primarily the result of higher gross profit partially offset by higher operating expenses as described above. Adjusted EBITDA was $70.7 million compared to $65.1 million in the same quarter last year (see table at the end of this press release).

Income tax expense under ASC 606 was $17.5 million resulting in an effective tax rate of 93% compared to $15.6 million and an effective tax rate of 28% in the same quarter last year. Income tax expense during the quarter reflects $11.4 million of expense primarily for a state valuation allowance due to New Jersey tax reform enacted during the fourth quarter of 2018. The fourth quarter of 2018 also includes the immediate recognition of certain effects of share-based compensation, acquisition and integration expenses, amortization of purchased intangibles, unrealized gain on investment in equity securities and the finalization of the U.S. tax reform toll charge on undistributed foreign earnings. Under ASC 605 and excluding these items, the effective tax rate would have been approximately 22% during the quarter.

Income from continuing operations under ASC 606 was $1.3 million. Under ASC 605, Income from continuing operations was $32.3 million, or $0.96 per diluted share, compared to $40.2 million, or $1.20 per diluted share, in the same quarter last year.

Adjusted Income from continuing operations, calculated under ASC 605, to be comparable to the prior year results, and including other adjustments described in the table at the end of this press release, was $48.7 million or $1.44 per share, compared to $42.3 million or $1.26 per share in the same quarter last year.

Capital expenditures were $19.1 million and depreciation and amortization was $13.7 million compared to $13.9 million and $8.8 million, respectively, in the same quarter last year.

Net debt was $204.1 million at the end of the quarter, a decrease of $23.7 million during the quarter primarily driven by cash flows from operations.

As a result of the Halo acquisition in September 2018, and to be in alignment with how the business is managed, the Company’s operating segments were aggregated to form two reportable segments, Active Pharmaceutical Ingredients ("APIs") and Finished Dosage Form ("FDF"). The API segment consists of four operating segments which manufactures APIs. The FDF segment consists of one operating segment which manufactures and develops finished dosage form products.

Fourth Quarter 2018 Operating Results – Active Pharmaceutical Ingredients ("API") segment

Net revenue was $110.9 million under ASC 606. Under ASC 605, net revenue was $189.1 million compared to $182.3 in the same quarter last year, a 3.7% increase. Results under ASC 605 include a 2% unfavorable impact of foreign exchange compared to the fourth quarter of 2017. Higher sales of controlled substances was the primary driver of the increase under ASC 605 compared to the same quarter last year.

Gross profit in the fourth quarter of 2018 was $42.6 million. Under ASC 605, Gross profit would have been $81.8 million compared to $78.9 million in the same quarter last year. Gross margins decreased to 38% from 43% in the same quarter last year. Excluding the impact of the new revenue recognition standard, gross margins would have been 43%.

Selling, general and administrative ("SG&A") expenses were $10.2 million in the fourth quarter 2018, compared to $14.0 million in the same quarter last year. The decrease was mainly due to lower personnel related costs and consulting expenses.

Operating profit was $29.3 million under ASC 606 in the fourth quarter 2018. Under ASC 605, operating profit was $68.6 million compared to $61.9 in the fourth quarter 2017. The increase in operating profit under ASC 605 was due to higher gross profit and lower operating expenses.

Fourth Quarter 2018 Operating Results – Finished Dosage Form ("FDF") segment

Results on an ASC 605 basis were not materially different than the reported results under ASC 606.

FDF Net revenue in the fourth quarter of 2018 was $23.4 million under ASC 606.

Gross profit was $5.7 million and gross margin was 24% under ASC 606 in the fourth quarter of 2018.

Selling, general and administrative expenses were $5.4 million in the fourth quarter of 2018 including amortization of purchased intangibles of $3.0 million.

Acquisition and Integration expenses of $1.1 million for the fourth quarter of 2018 represent costs associated with the acquisitions of Halo and Avista.

Operating loss under ASC 606 was $0.7 million. Operating loss includes $1.1 million in integration costs and approximately $3.3 million of increased depreciation and amortization expense resulting from the application of purchase accounting.

Fourth Quarter 2018 Operating Results – Corporate Headquarters

Selling, general and administrative expenses were $5.9 million in the fourth quarter of 2018 compared to $4.3 million in the same quarter last year. The increase is primarily related to higher personnel related expenses.

Acquisition and Integration expenses of $2.3 million for the fourth quarter of 2018 represent costs associated with the acquisitions of Halo and Avista.

Operating loss in the fourth quarter 2018 was $8.8 million compared to $5.6 million in the same quarter last year.

Financial Expectations – Continuing Operations

The following table shows the Company’s current expectations for its full year 2019 financial performance. The expectations in the table below reflect expected results from the business including the recent acquisitions of Halo and Avista. All expectations for 2019, including growth relative to 2018, are based on actual and expected ASC 606 results for both years.

Consistent with the Company’s usual guidance practices, these financial expectations are for continuing operations and exclude the impact of any potential future acquisitions and related transaction and integration expenses, including those related to the recent acquisitions of Halo Pharma and Avista Pharma Solutions, divestitures, restructuring activities, certain tax items discussed below, and the impact of foreign currency on Net revenue.

EBITDA, Adjusted EBITDA and Adjusted Income from continuing operations per share for 2019 will be computed on a basis consistent with the reconciliation of the current quarter financial results in the tables at the end of this press release, except that all 2019 results will be on an ASC 606 basis. Free cash flow is defined as the change in debt, net of cash during the year. Adjusted effective tax rate excludes the immediate recognition of certain benefits of share-based compensation and certain other items adjusted for in the non-GAAP reconciliation tables at the end of this release.

The tax rate will be sensitive to the Company’s geographic mix of income, changes in the tax laws or rates within the countries in which the Company operates and the effects of certain share-based payments. Reconciliations of these measures to measures calculated in accordance with GAAP are not available without unreasonable effort due to the unavailability of certain information needed to calculate certain reconciling items, including interest expense and income tax expense.

We expect M&A and related integration expenses for 2019 to be between $9 and $11 million. These amounts are excluded from our consolidated Adjusted EBITDA and Adjusted income from continuing operations per share guidance included above. These expenses consist of approximately $4.5 million of transaction expenses paid in conjunction with our acquisition of Avista in early January and the remainder will consist of integration expenses incurred across most functional areas throughout 2019. This estimate also includes certain immediate and one-time expenses related to IT systems, but does not include costs to upgrade the two newly acquired businesses to SAP, our ERP software, which will likely happen over the course of 2019 and 2020.

Expectations above include preliminary estimates for Depreciation expense associated with purchase accounting for the Avista acquisition. We expect to finalize the purchase accounting for Avista during the first half of 2019. As a result, expected Depreciation expense and its impact on expected Adjusted Income from continuing operations per share in the table below will likely change when purchase accounting is finalized.

Refer to the tables at the end of this press release which includes items typically adjusted to arrive at the Company’s non-GAAP results.

The financial information contained in this press release is unaudited, subject to revision and should not be considered final until the Company’s 2018 Form 10-K is filed with the SEC.

Conference Call and Webcast

A conference call to discuss the Company’s fourth quarter and full year 2018 results will begin at 8:30 a.m. Eastern Time on February 13, 2019 and can be accessed by calling 1-877-260-1479 for domestic and +1-334-323-0522 for international. Please use the passcode 2955208 and call approximately 10 minutes prior to the start time. A webcast will be available in the Investors section on the Cambrex website located at www.cambrex.com. A telephone replay of the conference call will be available through February 20, 2019 by calling 1-888-203-1112 for domestic and +1-719-457-0820 for international. Please use the passcode 2955208 to access the replay.

Innovent Announces First Patient Dosed in a Phase I Clinical Trial of an Anti-OX40 Antibody

On February 13, 2019 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality innovative medicines for the treatment of oncology, autoimmune and other major diseases, reported that the first patient has been dosed in a Phase I clinical trial of IBI101, a recombinant fully human anti-tumor necrosis factor receptor superfamily member 4 (anti-OX40) monoclonal antibody (Press release, Innovent Biologics, FEB 13, 2019, View Source [SID1234533290]).

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In this Phase I clinical study, the tolerance, safety and primary efficacy of IBI101, either as monotherapy or in combination with Tyvyt (sintilimab injection), an anti-programmed cell death protein 1 (PD-1) antibody, will be evaluated. The study comprises two parts, namely a Phase Ia study with IBI101 as monotherapy and a Phase Ib study with IBI101 in combination with Tyvyt. Patients with advanced solid tumors who have failed standard treatments will be enrolled in the study.

"The Investigational New Drug (IND) application of IBI101, indicated for patients with advanced solid tumors, was approved by the U.S. Food & Drug Administration (FDA) on 5 Dec, 2018. The mechanism of IBI101 is different from that of anti-PD-1 antibodies. IBI101 stimulates the OX40 pathway so as to activate effector T cells, thus enhancing the anti-tumor immune reaction," commented Professor XU Ruihua, Director of Sun Yat-Sen University Cancer Hospital. "Worldwide clinical research on anti-OX40 antibodies is limited so far. We are looking forward to the study results of IBI101."

"Innovent, a China-based company, was established with an ambition to serve global patient needs. We are dedicated to exploring the most advanced research areas in cancer immunotherapy and providing innovative medicines that improve lives around the world. The initiation of Phase I study of IBI101 and dosing of first patient have again demonstrated our efforts and commitment. We truly anticipate further breakthroughs so that more patients will potentially benefit in the future," said Michael Yu, Founder, Chief Executive Officer and Chairman.

About IBI101

IBI101 is a recombinant fully human anti-OX40 monoclonal antibody developed by Innovent with independent intellectual property rights. Pre-clinical data confirms that IBI101 has a clear mechanism of action that enhances the activation of effector T cells and mediates the clearance of regulatory T cells, thus inhibiting the growth of tumor cells. The IND application of IBI101 was approved by the U.S. FDA on 5 Dec, 2018. Agonistic OX40 candidates are expected to be used in combination with our anti-PD-1 monoclonal antibody, Tyvyt (sintilimab injection), and other immunomodulating agents in our R&D pipeline to meet the unmet medical needs of cancer patients. At present, there are no approved monoclonal antibody therapeutics against the same target across the world.

About Tyvyt (sintilimab injection)

Tyvyt (sintilimab injection) is an innovative drug jointly developed in China by Innovent and Eli Lilly and Company. Innovent is currently conducting the clinical studies of sintilimab injection in the United States. Tyvyt (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-1 Ligand-1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Tyvyt (sintilimab injection) is the only PD-1 antibody in China branded by both a local biopharmaceutical company and a global pharmaceutical company. Tyvyt (sintilimab injection) has been approved by the National Medical Products Administration (NMPA) for relapsed or refractory classical Hodgkin’s lymphoma (r/r cHL). Currently, more than twenty clinical studies of sintilimab injection, including seven registration studies, are ongoing to evaluate the efficacy of sintilimab injection on other solid tumors.

Cerus to Release Fourth Quarter and Full Year 2018 Results on February 26, 2019

On February 13, 2019 Cerus Corporation (Nasdaq:CERS) reported that its fourth quarter and full-year 2018 results will be released on Tuesday, February 26, 2019, after the close of the stock market (Press release, Cerus, FEB 13, 2019, View Source [SID1234533312]). The company will host a conference call and webcast at 4:30 P.M. EDT that afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook.

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To access the live webcast, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on the company’s website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 2392137. The replay will be available approximately three hours after the call through March 12, 2019.

Cartherics Pty Ltd teams up with Canada’s panCELLa Inc to bring the power of safe cell therapy to a greater number of patients

On February 13, 2019 Cartherics Pty Ltd ("Cartherics") and panCELLa Inc. ("panCELLa") are pleased to announce their collaboration to research, develop and commercialize products for the treatment of cancer and other debilitating diseases using cell therapy (Press release, Cartherics, FEB 13, 2019, View Source [SID1234553814]). panCELLa will integrate their exclusive FailSafeTM technology into Cartherics’ proprietary homozygous HLA haplotype cells to bring the power of safe cell therapy to a greater number of patients.

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"This technology is an important step to ensure the safety of the next generation of very effective gene-edited stem cell-derived immunotherapies," said Prof. Alan Trounson, CEO Cartherics.

Leveraging the science recently published in "Linking a cell division and a suicide gene to define and improve cell therapy safety" in the November 21st 2018 issue of Nature, panCELLa will maximize the safety level of Cartherics unique therapeutic cancer-killing cells (CAR-T Cells) by building in a molecular kill-switch among the genes of the cells, enabling the efficient elimination of dangerously dividing or rogue cells.

"We anticipate that this partnership will provide for the highest level of cell therapy safety," stated Dr. Andras Nagy, President and CSO of panCELLa. "We are pleased to partner with Cartherics to address the needs of immunotherapy treated cancer patients and to generate a FailSafe cell source for cell therapies in regenerative medicine. It is our mission to provide off-the-shelf universally safe cell therapies for all humankind."

Vanda Pharmaceuticals Reports Fourth Quarter 2018 and Full Year 2018 Financial Results

On February 13, 2019 Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) reported financial and operational results for the fourth quarter and full year ended December 31, 2018 (Press release, Vanda Pharmaceuticals, FEB 13, 2019, View Source [SID1234533291]).

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"The combination of strong commercial performance and positive clinical results has set 2018 apart as a transformative year for Vanda," said Mihael H. Polymeropoulos, M.D., Vanda’s President and CEO. "The tradipitant clinical programs in gastroparesis and atopic dermatitis have emerged as potentially significant drivers of future growth with the possibility of bringing new treatment options to millions of patients."

Key Financial Highlights:

Total net product sales from HETLIOZ and Fanapt were $53.0 million in the fourth quarter of 2018, an 8% increase compared to $49.1 million in the third quarter of 2018 and a 20% increase compared to $44.3 million in the fourth quarter of 2017.
HETLIOZ net product sales were $32.4 million in the fourth quarter of 2018, an 8% increase compared to $29.9 million in the third quarter of 2018 and a 30% increase compared to $25.0 million in the fourth quarter of 2017.
Fanapt net product sales were $20.6 million in the fourth quarter of 2018, a 7% increase compared to $19.2 million in the third quarter of 2018 and a 7% increase compared to $19.3 million in the fourth quarter of 2017.
Cash, cash equivalents and marketable securities (Cash) were $257.4 million as of December 31, 2018, representing an increase to Cash of $113.9 million during 2018.
Research and Development Highlights:

Tradipitant – Clinical Development

In December 2018, Vanda announced positive results from a Phase II clinical study (2301) of tradipitant in gastroparesis. Gastroparesis patients treated with tradipitant demonstrated significant improvement in nausea and most of the core gastroparesis symptoms.
Vanda expects to meet with the U.S. Food and Drug Administration (the FDA) to further define and confirm the path towards approval of tradipitant in the treatment of patients with gastroparesis, including the planned initiation of a Phase III clinical study in the second quarter of 2019.
Enrollment in the Phase III clinical study (EPIONE) of tradipitant in atopic dermatitis is ongoing. Results are expected in the first half of 2020. A second Phase III clinical study is expected to begin in the first quarter of 2020.
In January 2019, Vanda initiated a Phase II clinical study of tradipitant in motion sickness. Study results are expected in the second quarter of 2019.
HETLIOZ (tasimelteon)

In December 2018, Vanda announced positive results from a clinical study of HETLIOZ in Smith-Magenis Syndrome (SMS). SMS patients treated with HETLIOZ demonstrated significant improvement in overall sleep quality and overall total nighttime sleep duration.
Vanda expects to meet with the FDA in the second quarter of 2019 to confirm the regulatory path forward for HETLIOZ in the treatment of patients with SMS and expects to file a supplemental New Drug Application (sNDA) in the third quarter of 2019.
In December 2018, Vanda announced that the FDA had accepted the HETLIOZ sNDA for the treatment of jet lag disorder with a Prescription Drug User Fee Act target action date of August 16, 2019.
Vanda plans in the third quarter of 2019 to initiate a Phase II clinical study of HETLIOZ in delayed sleep phase disorder (DSPD) in patients who have a mutation in the CRY1 gene which is believed to be causative in a subset of patients with the disorder.
Fanapt (iloperidone)

Enrollment is ongoing in a pharmacokinetic study for the once-a-month long acting injectable (LAI) formulation of Fanapt. A randomized clinical study of the LAI formulation in schizophrenia is planned to begin in 2019.
A randomized study of Fanapt in bipolar disorder is planned to begin in 2019.
VTR-297 (histone deactetylase (HDAC) inhibitor)

Enrollment is ongoing in a Phase I clinical study (1101) of VTR-297 in hematologic malignancies.
Tradipitant – Partial Clinical Hold and FDA Dispute

In April 2018, Vanda submitted a protocol amendment to the FDA, proposing a 52-week open-label extension (OLE) period for patients who had completed the tradipitant Phase II clinical study (2301) in gastroparesis. In May 2018, based on feedback from the FDA, Vanda amended the protocol limiting the duration of treatment in the 2301 study to a total of three months, while continuing to seek further dialogue with the FDA on extending the study duration to 52-weeks. As a part of this negotiation process, in September 2018, Vanda submitted a new follow-on 52-week OLE protocol to the FDA (2302) for patients who had completed the 2301 study. While waiting for further feedback, no patients were ever enrolled in any study beyond 12 weeks.
On December 19, 2018, the FDA imposed a partial clinical hold (PCH) on the two proposed studies, stating that Vanda is required first to conduct additional chronic toxicity studies in canines, monkeys or minipigs before allowing patients access in any clinical protocol beyond 12 weeks. The PCH was not based on any safety or efficacy data related to tradipitant. Rather, the FDA informed Vanda that these additional toxicity studies are required by a guidance document.
On February 5, 2019, Vanda filed a lawsuit against the FDA in the United States District Court for the District of Columbia, challenging the FDA’s legal authority to issue the PCH, and seeking an order to set it aside.
Vanda does not expect the PCH to have any material impact on its ongoing clinical studies in atopic dermatitis and motion sickness or the planned Phase III study in gastroparesis. At present, the PCH has not had any impact on the potential timing of an NDA filing or approval for these indications. Vanda will continually reassess this situation as events unfold.
Non-GAAP Financial Results

Non-GAAP net income was $13.7 million for the fourth quarter of 2018, or $0.26 per share, compared to a Non-GAAP net income of $1.4 million, or $0.03 per share, for the fourth quarter of 2017. Vanda Non-GAAP net income was $38.4 million for the full year 2018, compared to a Non-GAAP net loss of $3.4 million for the full year 2017.

Vanda provides Non-GAAP financial information, which it believes can enhance an overall understanding of its financial performance when considered together with GAAP figures. Refer to the sections of this press release entitled "Non-GAAP Financial Information" and "Reconciliation of GAAP to Non-GAAP Financial Information" for more detailed information regarding Non-GAAP financial information.

2019 Financial Guidance

Conference Call

Vanda has scheduled a conference call for today, Wednesday, February 13, 2019, at 4:30 PM ET. During the call, Vanda’s management will discuss the fourth quarter and full year 2018 financial results and other corporate activities. Investors can call 1-866-688-9426 (domestic) or 1-409-216-0816 (international) and use passcode 1579398. A replay of the call will be available on Wednesday, February 13, 2019, beginning at 7:30 PM ET and will be accessible until Wednesday, February 20, 2019, at 7:30 PM ET. The replay call-in number is 1-855-859-2056 for domestic callers and 1-404-537-3406 for international callers. The passcode number is 1579398.

The conference call will be broadcast simultaneously on Vanda’s website, www.vandapharma.com. Investors should click on the Investor Relations tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda’s website for a period of 30 days.

Non-GAAP Financial Information

Vanda believes that the Non-GAAP financial information provided in this press release can assist investors in understanding and assessing the ongoing economics of Vanda’s business and reflect how it manages the business internally and sets operational goals. Vanda’s "Non-GAAP Selling, general and administrative expenses" and "Non-GAAP Research and development expenses" exclude stock-based compensation. Vanda’s "Non-GAAP Net income (loss)," "Non-GAAP Net income (loss) per share" and "Non-GAAP Operating expenses excluding Cost of goods sold" exclude stock-based compensation and intangible asset amortization.

Vanda believes that excluding the impact of these items better reflects the recurring economic characteristics of its business, as well as Vanda’s use of financial resources and its long-term performance.

These Non-GAAP financial measures, as presented, may not be comparable to similarly titled measures reported by other companies since not all companies may calculate these measures in an identical manner and, therefore, they are not necessarily an accurate measure of comparison between companies.

The presentation of these Non-GAAP financial measures is not intended to be considered in isolation or as a substitute for guidance prepared in accordance with GAAP. The principal limitation of these Non-GAAP financial measures is that they exclude significant elements that are required by GAAP to be recorded in Vanda’s financial statements. In addition, they are subject to inherent limitations as they reflect the exercise of judgments by management in determining these Non-GAAP financial measures. In order to compensate for these limitations, Vanda presents its Non-GAAP financial guidance in connection with its GAAP guidance. Investors are encouraged to review the reconciliation of our Non-GAAP financial measures to their most directly comparable GAAP financial measure.