Richard Chin - Founder, CEO Denise Bevers - Founder, COO Wendy Wee - VP, Finance.
Louis Chen - Guggenheim David Redfern - BMO Capital Markets.
Welcome to the Fourth Quarter 2014 Financial Results Conference Call and Webcast for Kindred Biosciences. At this time, all participants have been placed on a listen-only mode and the floor will be open for your questions following the presentation. When posing your question please pick-up your handset to allow optimal sound quality.
It is now my pleasure to turn the floor over to Kindred Bio's CEO and President, Richard Chin. Dr. Chin, please proceed..
Thank you, operator. Good afternoon and welcome to our 2014 year end earnings call.
I am very pleased to be joined today by the management team from Kindred Bio, Denise Bevers, our Chief Operating Officer, Wendy Wee, our new VP of Finance, Steve Sundlof, who has recently been promoted to Chief Scientific Officer and EVP of Regulatory Affairs and Quality and Allan Weingarten, who recently joined us from Merck Animal Health as Head of Clinical Development.
Before I begin, I should note that our remarks today will include forward-looking statement and that actual results could differ materially from those projected or implied in our forward-looking statements. For a description of important factors that could cause actual results to differ.
I refer you to the forward-looking statements in today's press release and a note on forward-looking statements in our SEC filings. I will start this call with a corporate update. Then Denise will give you an update on the status of our lead program. After Denise, Wendy will report on the 2014 financial highlights.
2014 was an exciting year for Kindred Bio marked by significant accomplishments as well as some challenges. Among the accomplishment, our first full year as a public company, we continued to build a world-class veterinary drug development organization of nearly 50 people, strengthen our management team and continue to advance on exciting pipeline.
Denise will talk about our pipeline in more detail. But, we now have over 20 programs with multiple molecules and indications for various clinical developments. We have not yet disclosed any of the molecules for competitive reason. But, we are very excited about the pipeline, which we believe is one of the strongest in the industry.
In particular, we are making excellent progress on biologic and we believe that we have some of the best antibody capabilities in the veterinary industry. Furthermore, we have validated our ability to execute programs on time and on budget.
We continue to believe that our lean approach to development will allow us to develop drugs at lower costs than many of our competitors and give us a significant advantage. I would like now to spend a few minutes introducing some of the new team members at Kindred Bio. I was very pleased to continue to work with world-class members.
Wendy Wee joined Kindred Bio as Vice President of Finance at the end of last year. Wendy has over 30 years of finance experience in the hi-tech and biotech industry. She joined Kindred Bio from Telik where she was VP of Finance and Controller for the clinical stage biopharmaceutical company.
Allan Weingarten is a veterinarian, who joined us several weeks ago as Head of Clinical Development. He comes from Merck Animal Health where we previously severed as Director of Pharmaceutical Research. His experience and over 20 years of veterinary drug development heading over a dozen drug development programs that were commercialized successfully.
Allan has an exceptional record of bringing veterinary medicine from concept all the way to commercialization. I'm also very pleased to announce the promotion of Steve Sundlof to Chief Scientific Officer and Executive Vice President of Regulatory Affairs and Quality.
In addition to being one of the most talented scientists with whom I had the pleasure of working with, Steve brings decades of experience from his tenure running the veterinary division of the FDA and as built an outstanding regulatory and quality development here at Kindred Bio.
In addition to our tremendously talented management team, I would like to note that we have built an exceptional team throughout the organization. Now turning to the program, in the last several months we have been focused on execution.
We believe that if we execute well, we will naturally demonstrate the value of our business model and looking ahead in 2015, we are on track to report out at least one and possibly two pivotal studies, SentiKin for post-operative pain in dogs and KIND-012 for fever in horses, also which Denise will discuss.
In addition, we expect several pilot studies to read out throughout the year. Now 2014 was also marked by some challenges. We believe in learning from [experience] [ph] and we have already taken the lessons learned and applied them to our pipeline of products.
For example, we are conducting more pilot studies internally rather than relying only on published pilot studies that we can conduct. We believe that this will further derisk our program. I should note, that the pilot studies if conducted properly can also be performed without a certain timeline, which will allow us to continue to execute quickly.
We are well-capitalized and have many promising programs in our pipeline. Our philosophy is to advance a diversified portfolio of multiple validated molecules in a highly capital efficient manner.
As you will hear from Wendy, we have an extremely capital efficient and given the amount of funding we have, we expect to be able to procure many attractive product candidates. This means that we are not dependent on any one or two programs for test. In addition, we are in a position to fund sequential business development.
We are very excited about our pipeline, our team and our commitment of being in the veterinary community. We take pride in being on the forefront of this emerging industry. Before, I turn the call over to Denise; I would like to note that in the future we plan to have quarterly earnings call as appropriate, but not necessarily every quarter.
Denise will now update you on our lead program..
Thank you, Richard. I would like to reiterate how pleased we are to have Allan Weingarten join our Kindred Bio family. Under Allan's leadership, we believe we have one of the top clinical development teams in veterinary drug development.
Once Allan had chance to completely come up to speed on our programs, you can look forward to future clinical updates from him. I would like to begin this update with our SentiKin program. I should note the slight change in the name which is a result of our negotiations with FDA.
As many of you know, we are actively enrolling our pivotal field trial for post-operative pain in dog. The enrollment has been going quite well and as mentioned previously, we have decided to expand the enrollment in this trial to increase the statistical power.
Given the current phase of the trial, we plan to report out on this program in the second half of this year. We have completed our target animal safety study and we will begin working on our safety technical section of the NADA, which we intend to submit in a timely manner in 2015.
We are also moving forward with our CMC activities and plan to have at least one additional CMC submission by the end of 2015.
We are also testing the active ingredient in SentiKin in several other indication including post-operative pain in cats, osteoarthritis in dogs as well as a handful of other indications that we are not yet prepared to disclose at this time.
We are very excited about this molecule and the fact that it is a non-NSAID, non-opioid, so we hope that it will eventually have many phase and effective therapeutic uses for dogs, cats and horses. Regarding KIND-012, our molecule for treating fever in horses, we have completed the PK study.
We are completing our pilot study and we are also beginning our start-up activity for the pivotal field study. We intend to report out on the pivotal field trials of KIND-012 at the end of 2015 or early 2016.
We are also completing our pilot study of KIND-010 for inappetence in cats and are about to start our pilot study for KIND-011 for metabolic syndrome in horses. We look forward to providing an update in 2015 regarding which of these programs will also be taken into pivotal field trial.
As Richard mentioned, we have a very strong biologics team and they have been making excellent progress on our biologics program. Our feline EPO program is moving ahead rapidly and we have started some laboratory studies already.
The anti-TNF and checkpoint inhibitor programs are also making excellent progress as well as multiple other biologics programs that we have not yet disclosed. Again, we look forward to providing update on meaning accomplishment and news in 2015.
This year, our number one goal is to complete positive pivotal trials to get some wins on the board, to prove that our model of lean drug development as a smart business model that would advance the practice of veterinary medicine. It is now my pleasure to turn the call over to Wendy to review our 2014 financial.
As the head of operations, I'm so pleased to have such a talented partner in finance as Wendy..
Thank you, Denise. For the quarter ended December 31, 2014, Kindred Bio recorded a net loss of $6.8 million or $0.34 per share as compared to a net loss of $2.4 million or $0.40 per share for the same period in 2013.
Research and development expenses for the fourth quarter of 2014 increased to $4.8 million as compared to $1.7 million for the same period in 2013. General and administrative expenses for the fourth quarter of 2014 increased to $2 million as compared to $641,000 for the same period in 2013.
For the year ended December 31, 2014, Kindred Bio reported a net loss of $27.1 million or $1.44 per share as compared to a net loss of $4.2 million or $1.13 per share for the same period in 2013.
Research and development expenses for the year ended December 31, 2014 were $18.7 million compared to $3.1 million in 2013, while general and administrative expenses were $8.5 million compared to $1.1 million in 2013.
The increase of $15.6 million in research and development expenses in 2014 compared to 2013 was primarily driven by the increase in outsourced development expense for SentiKin, AtoKin, CereKin and the company's other product development program in total of approximately $8.1 million.
In addition, research and development expenses also increased by $6.4 million due to payroll and related expenses as Kindred Bio increased it's headcount as well as consulting and stock-based compensation expenses.
The increase of $7.5 million in general and administrative expenses in 2014 over 2013 was due primarily to stock-based compensation expense, professional and consulting fees for legal, accounting and tax services, headcount related expenses and other general services as we operate as a public company.
As of December 31, 2014, Kindred Bio have $101 million in cash, cash equivalents and short-term investments, a net increase of $35.7 million from December 31, 2013.
This increase was due to the net cash proceed of $58.1 million from Kindred Bio's follow-on offering in April 2014 offset in part by cash use in operating activities of approximately $21.9 million. With respect to spending in 2015, as Richard mentioned, we are aggressively expanding our pipeline and accelerating our program.
As a result, we see our expenditures increasing from the annualized fourth quarter 2014 level of approximately $27.2 million. Accordingly, our guidance on spending for 2015 is $35 million to $40 million excluding the impact of stock-based compensation and the impact of acquisitions, if any.
We anticipate that we will be able to accomplish our current operating goals with these spending levels. These costs include the development of necessary regulatory and quality processes as we near the filing of registration for our product candidate.
Additionally, we are putting into place the necessary manufacturing requirements for possible commercialization in the following years. With that, I will turn the call back over to Richard..
Thank you, Wendy. Operator, we are ready for questions..
Thank you. [Operator Instructions] Our first question comes from the line of Louis Chen from Guggenheim..
Hi. Thanks for taking my questions. I had a few here. First question I had was something you addressed earlier but just wondering if you give more color here given some of the step backs that you had on your first two potential drugs.
What have you learned from this experience and how will it change things going forward with your business model with management? And then secondly, are you still interested in business development, and if so what areas, regions of the world, are there good opportunities out there that you have been reviewing? And then last question is just more color on the SentiKin enrollment exactly where you are with the numbers and what you need to meet – anything you could provide there would be very helpful.
Thank you..
Sure. I will take the first two questions and then I will turn it over Denise. In terms of lessons learned, part of the drug development is always looking ahead what went right and what went wrong and making cost adjustment.
And one of the cost adjustments that we are making as I mentioned earlier is, we are doing a lot more pilot studies using our own personnel, using our own design. We think by doing so will increase the speed probably the technical features on our program. Of course, having said that these are still clinical studies, it never guaranties success.
We think that what we are doing now will increase, probably the success.
In terms of business development, we are primarily focused on opportunities within the United States and either commercial or near commercial opportunities and we have been in discussions with multiple potential parties and we are optimistic, but we are not in a position to disclose any further. Denise please go ahead..
Hi, Louis. With regard to the SentiKin enrollment, the enrollment is actually going quite well. We had originally reported that we would report out on that in mid-2015. It's going a little slower than we anticipated given that it is a post-operative pain study. However, we are well on our way to reporting out in the second half of 2015.
We probably won't get much more granular beyond that as far as enrollment numbers, but rest assured that enrollment is going quite well..
Thank you..
Sure..
Thank you. Our next question comes from the line of Alex Arfaei from BMO Capital Markets..
Hi. This is David Redfern in for Alex Arfaei. In terms of SentiKin, wondering if you can give a bit of color about the other indications you mentioned in the past like post-operative pain horses and cats, osteoarthritis in dogs.
Also, regarding the various pilot studies, wondering if you could just give a bit more clarity on when we will you give the data for these and in which order and for which candidates.
And finally, you mentioned that you have been approached by potential partners who are interested in licensing before, whether you plan A is still to commercialize yourself.
Can you just give us an update on your commercialization strategy and whether or not you are still planning on building or maybe acquiring sales force like we are expecting, when did the other two lead programs are still on the pictures? Thank you..
Hi. Dave, its Denise. I will answer the first two, and then I will turn it over to Richard regarding the third question.
So for the pilot study at this point, what we have announced is what we are going to disclose at this time that we are working in post-operative pains in cats, osteoarthritis in dogs as well as some other indications which for competitive reasons we have not disclosed at this point.
As far as the other pilot studies that I talked about today, we are not going to necessarily say when the – what the order will be, however, please do know that as soon as we have data we will be sharing those as appropriate. And in addition, we will also keep this community apprise of what studies will be going into pivotal trials..
And with respect to potential possible partners out license, we have been approached by virtually every large veterinary pharmaceutical companies and we are continuing to talk to them. Our primary plan is to commercialize ourselves in the United States and out license in x U.S. territories.
However, we are keeping all our options open and ultimately our decisions will depend on what makes it most economic..
Great. Thank you..
Thank you. [Operator Instructions] And I see no further questions at this time. I would like to turn the conference back to management for any closing comments..
Thank you, operator. I would like to take a moment to thank the Kindred Bio's team for all of its hard work and dedication and to thank all of you who called in today for your support and interest in Kindred Bio. We are deeply committed to the future of veterinary drug development and look forward for the successes to come..
Thank you. Ladies and gentlemen, thank you for your participation in today's conference. This does conclude the program. And you may now disconnect. Everyone have a good day..