On May 10, 2016 Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX, ISIN: DE0005664809) reported financial results and corporate updates for the first quarter of 2016 (Press release, Evotec, MAY 10, 2016, View Source [SID:1234512324]).

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FINANCIAL PERFORMANCE: BEST Q1 FINANCIAL RESULTS IN COMPANY’S HISTORY

– Significant Group revenue growth of 74% to EUR 37.5 m (2015: EUR 21.5 m); base revenues up 83% to EUR 33.9 m

– Revenue growth in both operating segments: EVT Execute revenues up 67% to EUR 38.6 m, EVT Innovate revenues up 67% to EUR 6.4 m

– Adjusted Group EBITDA significantly increased to EUR 7.2 m (2015: EUR (0.3) m)

– Adjusted EBITDA of EUR 9.6 m for EVT Execute (2015: EUR 3.5 m)

– Increase in R&D expenses of 14% to EUR 4.4 m primarily focused on oncology projects and CNS

– Strong strategic liquidity position of EUR 122.5 m

EVT Execute – ACCELERATED GROWTH IN BASE BUSINESS

– Important milestone achievement in Padlock collaboration

– Multi-year compound management agreement closed with Pierre Fabre (after period-end)

– Milestone achievement in Bayer collaboration (after period-end)

EVT Innovate – FIRST-IN-CLASS CURE X/TARGET X STRATEGY

– Good progress in Cure X/Target X programmes

– Grant from The Michael J. Fox Foundation for Parkinson’s Research

– Good progress in existing partnerships (e.g. EVT201, EVT801 and other Sanofi oncology projects, kidney disease collaboration with AstraZeneca)

– Partnership on immuno-oncology therapeutics with ex scienta

– Phase out of EVT100 in TRD by Janssen Pharmaceuticals

EVT EQUITY – COMPANY FORMATION TO ACCELERATE DRUG DISCOVERY AND PRODUCT DEVELOPMENT

– Formation of a spin-off company (Topas Therapeutics GmbH) in the field of nanoparticle-based therapeutics to treat immunological disorders; completed Series A funding of EUR 14 m

MANAGEMENT BOARD UPDATES AND STRENGTHENING OF GLOBAL HUMAN RESOURCES CAPACITIES

– CEO, COO and CSO contracts extended

– Contract of Colin Bond, CFO, will end 30 June 2016

– Appointment of Enno Spillner as new CFO effective 18 July 2016

– Appointment of Monika Conradt as Global Head of Human Resources effective 01 June 2016

GUIDANCE 2016 CONFIRMED

1. Financial performance

BEST Q1 FINANCIAL RESULTS IN COMPANY’S HISTORY

The 2015 and 2016 results are not fully comparable. The difference stems from the acquisition of Evotec (France) SAS, effective 01 April 2015. While the results of Evotec (France) SAS are fully included in the accompanying consolidated income statement for the first three months of 2016, they were not included in the comparable period of the previous year.

The presented financial statements include a change in presentation in the first three months of 2015 and 2016. From 01 January 2016 onwards, amortisation of intangible assets are no longer presented in a separate line in the consolidated income statement but are allocated to the relating cost lines in the income statement. The prior-year period was changed accordingly resulting in higher costs of revenue (EUR 0.6 m).

In the first quarter of 2016, Evotec’s Group revenues grew to EUR 37.5 m, an increase of 74% compared to the same period of the previous year (2015: EUR 21.5 m). This increase resulted primarily from an increase in base revenues across all business units and the contribution from the Sanofi collaboration. Excluding milestones, upfronts and licences, Evotec’s revenues for the first quarter of 2016 were EUR 33.9 m, an increase of 83% over the same period of the previous year (2015: EUR 18.5 m). Revenues from milestones, upfronts and licences increased to EUR 3.6 m compared to the same period of the previous year (EUR 3.0 m). The gross margin amounted to 33.3% in the first three months of 2016 (2015: 28.0%). This significant margin increase over 2015 primarily reflects growth in base revenues, improved capacity utilisation as well as favourable foreign exchange rate effects.

In the first quarter of 2016, Evotec’s R&D expenses amounted to EUR 4.4 m (2015: EUR 3.8 m). This increase is in-line with the Company’s strategic plans and primarily results from significant investments in acquired oncology projects and intensified investments in CNS projects. Selling, general and administrative (SG&A) expenses increased by 5% in the first quarter of 2016 to EUR 5.4 m (2015: EUR 5.1 m) and were mainly impacted by ongoing costs at Toulouse site.

Adjusted Group EBITDA in the first quarter of 2016 was positive and amounted to EUR 7.2 m (2015: EUR (0.3) m). EBITDA was adjusted for changes in contingent consideration. Evotec’s operating income in the first quarter of 2016 amounted to EUR 2.7 m (2015: operating loss of EUR 3.3 m).

Liquidity, which includes cash and cash equivalents (EUR 49.2 m) and investments (EUR 73.3 m) amounted to EUR 122.5 m as of 31 March 2016 (31 December 2015: EUR 133.9 m) and remained on a high level even though the first quarter of 2016 was affected by bonuses, extraordinary and advance payments. In the current low and negative interest rate environment, the Company is considering options to reduce outstanding levels of debt during Q2 2016 while maintaining future access to such financing. Debt reduction would be possible due to the current strength of the underlying business and the strong liquidity position of the Company.

Revenues from the EVT Execute segment amounted to EUR 38.6 m in the first quarter of 2016 (2015: EUR 23.1 m) and included EUR 7.5 m of intersegment revenues (2015: EUR 5.4 m). This sharp increase was mainly driven by the strong performance of the base business, the milestone achievement in the Padlock collaboration and the contribution from the Sanofi transaction. The EVT Innovate segment generated revenues of EUR 6.4 m (2015: EUR 3.8 m) consisting entirely of third-party revenues. This increase compared to the prior year results mainly from EVT Innovate projects which were partnered in 2015. Gross margin for EVT Execute amounted to 26.1% while EVT Innovate generated a gross margin of 46.1%. R&D expenses for the EVT Innovate segment amounted to EUR 4.9 m in the first quarter of 2016 (2015: EUR 4.6 m) and continued the upward trend compared to previous quarters. In the first quarter of 2016, the adjusted EBITDA (before changes in contingent consideration) of the EVT Execute segment was strongly positive at EUR 9.6 m and improved compared to the same period of the previous year (2015: EUR 3.5 m). The EVT Innovate segment reported a negative EBITDA before changes in contingent consideration of EUR (2.4) m but has improved over the prior year (2015: EUR (3.8) m) due to new EVT Innovate partnerships based on Cure X/Target X initiatives signed in 2015.

2. EVT Execute and EVT Innovate

EVT Execute – ACCELERATED GROWTH IN BASE BUSINESS

The first quarter of 2016 saw a strong operational performance in the EVT Execute segment. Important milestones were achieved in ongoing collaborations (Padlock; Bayer (after period-end)). In addition, the base business gained further momentum, especially with regards to compound management services, which was further demonstrated by new multi-year compound management agreements which Evotec entered with UCB at the end of 2015 and with Pierre Fabre just after period-end.

EVT Innovate – FIRST-IN-CLASS CURE X/TARGET X STRATEGY

In the EVT Innovate segment, Evotec recorded a research grant which was awarded from The Michael J. Fox Foundation to further develop Evotec’s TargetaSN (Targetalpha-synuclein) programme for the treatment of Parkinson’s disease. This programme is part of a larger internal initiative to address neurodegenerative diseases through highly innovative approaches involving patient-derived stem cells and genetically validated mechanisms. Furthermore, good progress was demonstrated in existing partnerships and development projects in the first quarter: The clinical studies for EVT201 in China are running according to plan. EVT801 and other oncology projects are progressing well. Good progress was achieved in the kidney collaboration with AstraZeneca. Regarding Evotec’s legacy pipeline, Evotec was informed by Janssen Pharmaceuticals, Inc. that Janssen intends to phase out the agreement regarding NMDA antagonists as of August 2016. This is reflected in a full impairment of the asset in the amount of EUR 1.4 m.

3. EVT Equity – Company formation to accelerate drug discovery and product development

In March 2016, Evotec announced the formation of a spin-off company, called Topas Therapeutics GmbH ("Topas"), focused on the field of nanoparticle-based therapeutics to treat immunological disorders. Epidarex Capital, EMBL Ventures and Gimv participated together with Evotec in a EUR 14 m ($ 15.75 m) Series A financing round of Topas. Evotec will remain the largest shareholder after the financing round. The new company aims to build a unique pipeline of clinical-stage development projects to treat autoimmune diseases. The establishment of Topas is the first example of an acceleration of Evotec’s business model to take advantage of carving out promising programmes with upside potential on a shared risk and shared success basis.

4. Management Board updates and strengthening of Global Human Resources capacities

The Supervisory Board has agreed to the extension of the service contract of Dr Werner Lanthaler as CEO of the Company for another five years to 2021 and the extensions of the contracts of Dr Mario Polywka as COO and Dr Cord Dohrmann as CSO for a further three years to 2019. Colin Bond has decided not to extend his contract and will leave the Company at his own request when his current contract as CFO expires at the end of June 2016.

The Supervisory Board of Evotec has appointed Enno Spillner as its new Chief Financial Officer and member of the Management Board effective 18 July 2016. Enno Spillner has most recently served as Chairman of the Management Board and CEO/CFO of 4SC AG since April 2013. He joined 4SC AG as CFO in September 2005. Before working for 4SC AG, Enno Spillner was Head of Finance and Controlling at BioM AG, a German regional biotech venture fund, which he joined at the beginning of 1999. In this role, he was responsible for managing investments in the equity portfolio and also held the position of interim Managing Director at two portfolio companies. Enno Spillner earned his Dipl.-Kaufmann degree (Masters in Economics) at the University of Bamberg, Germany. He also is a member of the Supervisory Board and Chairman of the audit committee at Nanobiotix, Paris.

To support the growth and increase attention to its human talent, the Management Board of Evotec has appointed Ms Monika Conradt Global Head of Human Resources. Ms Conradt joins Evotec from Boehringer Ingelheim, where she has been HR Manager Europe.

Dr Werner Lanthaler, Chief Executive Officer of Evotec, commented: "On behalf of the Management Board and the Company, I would like to thank Colin for his most valuable contributions over the past six years. He was outstanding in the challenge and balance that he provided to the Management Team. Colin Bond has made many essential contributions to the strategic development of Evotec. We will closely stay in touch with him and we wish him ongoing success for his future endeavours in a key position at one of our drug discovery partners. I am delighted to welcome Enno Spillner to our team as new Chief Financial Officer and Monika Conradt as Global Head of Human Resources."

5. Guidance 2016 confirmed

Guidance 2016 Actual 2015
Base revenues1) >15% EUR 115.4 m
Adjusted Group EBITDA2) Positive and significantly improved to prior year EUR 8.7 m
R&D expenses Approx. EUR 20 m EUR 18.3 m
Liquidity3) Similar level to prior year EUR 134.5 m
Capex investments Up to EUR 10 m EUR 11.2 m
1) Excluding milestones, upfronts and licences

2) Before contingent considerations, income from bargain purchase and excluding impairments on goodwill, other intangible and tangible assets as well as the total non-operating result
3) Excluding M&A and related payments

On May 10, 2016 SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) reported financial results for the quarter ended March 31, 2016 (Press release, SciClone Pharmaceuticals, MAY 10, 2016, View Source [SID:1234512322]).

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Revenues: In the first quarter 2016, SciClone reported revenues of $36.5 million, compared to $33.6 million for the same period in 2015.
GAAP Diluted EPS: In the first quarter 2016, SciClone reported GAAP diluted earnings per share of $0.15, compared to $0.17 for the same period in 2015.
Non-GAAP Diluted EPS: In the first quarter 2016, SciClone reported non-GAAP diluted earnings per share of $0.19, compared to $0.19 for the same period in 2015.
Revenues in the first quarter of 2016 were $36.5 million, a $2.9 million or 9% increase, compared to $33.6 million for the same period in 2015. ZADAXIN revenues were $33.6 million in the first quarter of 2016, a $2.3 million or 7% increase, compared to $31.3 million for the same period in 2015. Promotion services revenues were $1.2 million for the first quarter of 2016, a $0.8 million or 195% increase, compared to $0.4 million in the same period in 2015.

On a GAAP basis, SciClone reported net income in the first quarter of 2016 of $7.9 million, or $0.16 and $0.15 per share on a basic and diluted basis, respectively, compared to net income of approximately $9.0 million, or $0.18 and $0.17 per share on a basic and diluted basis, respectively, for the same period in 2015.

SciClone’s non-GAAP net income in the first quarter of 2016 was $9.7 million, or $0.20 and $0.19 per share on a basic and diluted basis, respectively, compared with non-GAAP net income of $9.8 million, or $0.20 and $0.19 per share on a basic and diluted basis, respectively, for the same period of the prior year.

Friedhelm Blobel, PhD, SciClone’s Chief Executive Officer commented: "Building on our 2015 momentum, we delivered another strong quarterly performance. Our core business, driven by ZADAXIN, continued to outpace the growth rate of the China pharma market. Today, ZADAXIN has achieved more than 40% of the value share in the thymalfasin market category in China, and our volume share has increased to 17%, an impressive achievement. We achieved substantial growth in our oncology portfolio this quarter compared to prior quarters, including the products we promote for our pharmaceutical partners, Baxter and Pfizer. While still modest in size, our oncology portfolio is a key strategic asset for our Company. We anticipate continued growth in the coming years as we introduce additional anticancer products into the market."

Continued Dr. Blobel: "We are continuing to implement academic marketing strategies to build the market for DC Bead as a novel treatment for liver cancer and alternative to conventional TACE procedures using gels. We are seeing increased utilization in the market, which we believe will translate into growing sales this year. Our development portfolio continues to progress on track, and we anticipate achieving important regulatory milestones in the next few years."

For the first quarter of 2016, sales and marketing (S&M) expenses were $12.4 million, compared with $11.4 million for the same period in 2015. The increase in S&M for first quarter of 2016, compared to the same period in 2015, related to increases in sales and marketing efforts for ZADAXIN.

For the first quarter of 2016, research and development (R&D) expenses were $1.5 million, compared with $1.1 million of R&D expenses for the same period of 2015. R&D was higher for the first quarter of 2016, compared to the first quarter of 2015, related to in-licensing agreements with certain business partners and R&D activities in China.

For the first quarter of 2016, general and administrative (G&A) expenses were $7.4 million, compared with $7.0 million for the same period in 2015. G&A was higher for the first quarter of 2016, compared to the first quarter of 2015, related to higher legal costs primarily in connection with the Company’s strategic review to maximize shareholder value and related to higher stock-based compensation expenses.

For the first quarter of 2016, tax provision was $1.9 million, compared with $0.6 million for the same period in 2015. The $1.9 million tax provision for the first quarter of 2016 included a $1.2 million uncertain tax provision for our China operations from 2013 to 2015.

As of March 31, 2016, cash, cash equivalents and short-term investments totaled $114.7 million, compared to $101.4 million as of December 31, 2015, excluding the $12.8 million of restricted cash held in escrow as of December 31, 2015 for the SEC settlement which was released and paid in February 2016.

SciClone has presented non-GAAP information above as the Company believes this non-GAAP information is useful for investors, taken in conjunction with SciClone’s GAAP financial statements, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of SciClone’s operating results as reported under GAAP. The non-GAAP calculations and reconciliation are provided in the accompanying table titled "Reconciliation of GAAP to Non-GAAP Net Income."

On May 10, 2016 Repros Therapeutics Inc. (Nasdaq:RPRX) reported financial results for the first quarter ended March 31, 2016 (Press release, Repros Therapeutics, MAY 10, 2016, View Source [SID:1234512321]).

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Financial Results

Net loss for the three month period ended March 31, 2016 was ($4.8) million, or ($0.20) per share, as compared to a net loss of ($8.5) million, or ($0.35) per share, for the same period in 2015. The decrease in net loss for the three month period ended March 31, 2016 as compared to the same period in 2015 was primarily due to decreases in clinical development expenses related to the Company’s enclomiphene product candidate, research and development payroll and benefits expenses and legal expenses, partially offset by an increase in clinical development expenses related to Proellex.

Research and development ("R&D") expenses decreased 49%, or $3.5 million, to $3.8 million for the three month period ended March 31, 2016, as compared to $7.3 million for the same period in the prior year. R&D expenses related to the clinical development of enclomiphene decreased 71%, or approximately $2.9 million, for the three month period ended March 31, 2016 as compared to the prior year period, primarily due to the submission of the NDA to the FDA in the first quarter of 2015. R&D expenses related to the clinical development of Proellex increased 41%, or approximately $336,000, from the 2015 period to the 2016 period, due to increased expenses associated with our ongoing Phase 2B clinical trials for the treatment of uterine fibroids. Payroll and benefits expenses decreased 45%, or approximately $580,000, to $712,000 for the three month period ended March 31, 2016 as compared to $1.3 million for the same period in the prior year. Included in payroll and benefits expense is a charge for non-cash stock-based compensation of $193,000 for the three month period ended March 31, 2016 as compared to $574,000 for the same period in the prior year. Additionally, salaries for the three month period ended March 31, 2016 were $422,000 as compared to $579,000 for the same period in the prior year. Operating and occupancy expenses decreased 37%, or approximately $423,000, to $716,000 for the three month period ended March 31, 2016 as compared to $1.1 million for the same period in the prior year, primarily due to decreased legal expenses.

General and administrative ("G&A") expenses decreased 9%, or approximately $109,000, to $1.1 million for the three month period ended March 31, 2016 as compared to $1.2 million for the same period in the prior year. Payroll and benefits expense decreased 17%, or approximately $123,000, to $620,000 for the three month period ended March 31, 2016 as compared to $743,000 for the same period in the prior year. Included in payroll and benefits expense is a charge for non-cash stock based compensation expense of $323,000 for the three month period ended March 31, 2016 as compared to $448,000 for the same period in the prior year. Additionally, salaries for the three month period ended March 31, 2016 were $257,000 as compared to $255,000 for the same period in the prior year. G&A operating and occupancy expense increased 3%, or approximately $14,000, to $476,000 for the three month period ended March 31, 2016 as compared to $462,000 for the same period in the prior year primarily due to an increase in legal expenses.

Interest income increased to $17,000 for the three month period ended March 31, 2016 as compared to $1,000 for the same period in the prior year. The increase was primarily due to higher yields for the three month period ended March 31, 2016 as compared to the prior year.

Liquidity and Capital Resources

The Company had cash and cash equivalents of $16.0 million as of March 31, 2016 as compared to $21.4 million as of December 31, 2015. Net cash of approximately $5.3 million and $8.8 million was used in operating activities during the three month periods ended March 31, 2016 and 2015, respectively. The major use of cash for operating activities for the three month period ended March 31, 2016 was to fund our clinical development programs and associated administrative costs. No cash was used in investing activities during the three month period ended March 31, 2016 and no cash was provided by financing activities during the three month period ended March 31, 2016.

As of March 31, 2016, the Company had 24,318,111 shares of common stock outstanding.

On May 10, 2016 Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.pvct.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or "the Company"), reported its financial results for the first quarter 2016 ended March 31, 2016 (Press release, Provectus Pharmaceuticals, MAY 10, 2016, View Source [SID:1234512317]).

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First Quarter Results and Balance Sheet Highlights

Our cash and cash equivalents were $9,760,997 at March 31, 2016, compared with $14,178,902 at December 31, 2015. The decrease of approximately $4.4 million was due primarily to the $8.0 million in cash used to fund our operating activities for the quarter offset by $3.6 million in cash received from the warrant exchange offer in the quarter ended March 31, 2016. Additional sales of common stock have been reduced since we are seeking to minimize dilution to our existing stockholders where practicable by limiting the issuance of our equity securities.

By managing variable cash expenses due to minimal fixed costs, we believe our cash and cash equivalents on hand at March 31, 2016, will be sufficient to meet our current and planned operating needs until into 2017 without consideration being given to additional cash inflows that might occur from the exercise of outstanding warrants or future sales of equity securities.

Shareholders’ equity at March 31, 2016 was $14,184,248. This compares to shareholders’ equity at December 31, 2015 of $16,316,941.

For additional information regarding Provectus’ results of operations and financial condition for the first quarter ended March 31, 2016, please see Provectus’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 10, 2016.

On May 10, 2016 CEL-SCI Corporation (NYSE MKT: CVM) reported financial results for the quarter ended March 31, 2016 (Press release, Cel-Sci, MAY 10, 2016, View Source [SID:1234512270]).

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Key corporate and clinical developments during second quarter fiscal year 2016 include:

Enrolled an additional 186 patients in the global pivotal Phase 3 head and neck cancer trial during the first six months of FY 2016, a 32% increase in enrollment compared to the first six months of FY 2015.
Enrolled a monthly record of 41 patients in April 2016, following the end of Q2.
A total of 797 patients have been enrolled in the study as of April 30, 2016.
The Company’s CEO and CSO provided informative updates in multiple interviews, including Fox Business News.
Continued patient enrollment in the Phase 1 trial of Multikine* in HIV/HPV co-infected men and women with peri-anal warts at San Diego Naval Medical Center and University of California, San Francisco (UCSF).
Received significant litigation funding for arbitration lawsuit against former CRO that led to a narrowing of G&A expense and operating loss in Q2 FY 2016.
CEL-SCI reported an operating loss of ($6,273,603) for the quarter ended March 31, 2016 versus an operating loss of ($7,759,343) for the quarter ended March 31, 2015. The operating loss for the six months ended March 31, 2016 was ($12,056,735) versus ($17,755,084) during the six months ended March 31, 2015. The decrease in operating loss in the first half of fiscal 2016 was mostly attributable to a decrease in general and administrative expenses of approximately $5,803,000, as compared to the first half of fiscal 2015. A major component of the decrease is the approximate $3,254,000 gain on the derecognition of legal fees recognized pursuant to an agreement with Lake Whillans for funding litigation expenses in the Company’s arbitration against its former CRO. Additionally, during the first half of fiscal 2015, there was approximately $2,726,000 in employee compensation costs related to the issuance of shareholder approved shares of restricted stock released upon meeting predetermined milestones. Research and development expenses remained relatively consistent and decreased by $176,000 during the six months ended March 31, 2016.

CEL-SCI’s net loss available to common shareholders for the quarter ended March 31, 2016 was ($8,844,855) or ($0.07) per basic and diluted share, versus ($12,556,236) or ($0.17) per basic and diluted share during the quarter ended March 31, 2015. The net loss available to common shareholders for the six months ended March 31, 2016 was ($6,503,042) or ($0.06) per basic and diluted share, versus ($20,401,554) or ($0.27) per basic and diluted share during the same six months ended March 31, 2015. The decrease in net loss for the three and six month periods of 2016 as compared to the same periods in 2015 was primarily attributable to the decrease in operating loss and reduced loss and unrealized gain, respectively, on the fair value of warrants as a result of the change in the stock price between reporting periods.

About Multikine (Leukocyte Interleukin, Injection)

Multikine is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase 3 clinical trial as a potential first-line treatment for advanced primary (not yet treated) squamous cell carcinoma of the head and neck. Multikine is designed to be a different type of therapy in the fight against cancer: one that appears to have the potential to work with the body’s natural immune system in the fight against tumors.